14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399144|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399188|NCT00622518|P1|Participant Flow|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
399190|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
399145|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399146|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399147|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399148|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399149|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399150|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399151|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399152|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399153|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399154|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399155|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399156|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399157|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399158|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399159|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399160|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399161|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399162|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399163|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399164|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399189|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
399235|NCT00622388|O1|Outcome|Overall Study Arm|
399165|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399166|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399167|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399168|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399169|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399170|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399171|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399172|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399173|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399174|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399175|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399176|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399177|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399178|NCT00622635|O3|Outcome|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399179|NCT00622635|O2|Outcome|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399180|NCT00622635|O1|Outcome|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399181|NCT00622635|E3|Reported Event|Placebo to Indacaterol|Placebo to indacaterol was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399182|NCT00622635|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 µg was inhaled twice daily for 14 days using a multi-dose dry-powder inhaler (MDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399183|NCT00622635|E1|Reported Event|Indacaterol 300 μg|Indacaterol 300 µg was inhaled once daily for 14 days using a single-dose dry-powder inhaler (SDDPI) device. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
399184|NCT00622518|B3|Baseline|Total|Total of all reporting groups
399185|NCT00622518|B2|Baseline|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
399186|NCT00622518|B1|Baseline|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
399187|NCT00622518|P2|Participant Flow|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
399191|NCT00622518|O2|Outcome|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
399192|NCT00622518|O1|Outcome|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
399193|NCT00622518|E2|Reported Event|Standard Therapy Alone|No ear drops, standard care for otitis including antibiotics and/or medications to help with ear pain including acetaminophen and ibuprofen
399194|NCT00622518|E1|Reported Event|Ear Drops Plus Standard Therapy|homeopathic ear drops in addition to standard care for otitis media
399195|NCT00622440|B3|Baseline|Total|Total of all reporting groups
399196|NCT00622440|B2|Baseline|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399197|NCT00622440|B1|Baseline|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399198|NCT00622440|P2|Participant Flow|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399199|NCT00622440|P1|Participant Flow|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399200|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399201|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399202|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399203|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399204|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399205|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399206|NCT00622440|O2|Outcome|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399207|NCT00622440|O1|Outcome|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399208|NCT00622440|E2|Reported Event|Placebo|Placebo: Participants administer 1/4 teaspoon of placebo cream twice daily for 48 weeks.
399209|NCT00622440|E1|Reported Event|AIJP|AIJP (Arnebia Indigo Jade Pearl): Participants administer 1/4 teaspoon of AIJP cream twice daily for 48 weeks.
399210|NCT00622427|B3|Baseline|Total|Total of all reporting groups
399211|NCT00622427|B2|Baseline|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
399212|NCT00622427|B1|Baseline|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
399213|NCT00622427|P2|Participant Flow|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
399214|NCT00622427|P1|Participant Flow|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
399215|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep
399216|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep
399217|NCT00622427|O2|Outcome|Placebo|QD for 14 days prior to sleep first
399218|NCT00622427|O1|Outcome|Ramelteon|QD for 14 days prior to sleep first
399219|NCT00622427|E2|Reported Event|Placebo Then Ramelteon (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then Ramelteon QD for 14 days prior to sleep
399220|NCT00622427|E1|Reported Event|Ramelteon Then Placebo (8 mg)|QD for 14 days prior to sleep first, 2 week wash out period, then placebo QD for 14 days prior to sleep
399221|NCT00622401|B4|Baseline|Total|Total of all reporting groups
399222|NCT00622401|B3|Baseline|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
399223|NCT00622401|B2|Baseline|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
399224|NCT00622401|B1|Baseline|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
399225|NCT00622401|P3|Participant Flow|Group 3: Dendritic Cell/Tumor Fusion Vaccine and Higher Dose I|"Dendritic Cell/tumor fusion vaccine and higher dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 100ng/kg"
399226|NCT00622401|P2|Participant Flow|Group 2: Dendritic Cell/Tumor Fusion Vaccine and Low Dose IL-1|"Dendritic Cell/tumor fusion vaccine and low dose IL-12~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells~Interleukin-12: Given subcutaneously at dose of 30ng/kg"
399227|NCT00622401|P1|Participant Flow|Group 1: Dendritic Cell/Tumor Fusion Vaccine Only|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
399228|NCT00622401|O1|Outcome|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
399229|NCT00622401|E1|Reported Event|Group 1|"Dendritic Cell/Tumor Fusion Vaccine Only~Dendritic Cell/Tumor Fusion Vaccine: Vaccine is derived from the participants dendritic cells and tumor cells"
399230|NCT00622388|B1|Baseline|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399231|NCT00622388|P1|Participant Flow|Ofatumumab|Participants received 8 weekly intravenous (iv) infusions of ofatumumab: first infusion of 300 milligrams (mg), followed by 7 infusions of 1000 mg
399232|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399233|NCT00622388|O1|Outcome|Overall Study Arm|
399234|NCT00622388|O1|Outcome|Overall Study Arm|
399236|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399237|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399238|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399239|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399240|NCT00622388|O1|Outcome|Overall Study Arm|
399241|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399242|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399243|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399244|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399245|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399246|NCT00622388|O1|Outcome|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399247|NCT00622388|E1|Reported Event|Ofatumumab|Participants received 8 weekly iv infusions of ofatumumab: first infusion of 300 mg, followed by 7 infusions of 1000 mg
399248|NCT00622336|B1|Baseline|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
399249|NCT00622336|P1|Participant Flow|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399250|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
399251|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399252|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399253|NCT00622336|O1|Outcome|Lenalidomide 25mg|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399254|NCT00622336|O1|Outcome|Lenalidomide 25mg (CC-5013)|Oral 25mg daily on Days 1-21 every 28 days
399255|NCT00622336|E2|Reported Event|Lenalidomide ( ExtensionPhase) 22 Oct 2009 to 11 November 2013|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399256|NCT00622336|E1|Reported Event|Lenalidomide (Treatment Phase) Up to Data Cut-off 22 Oct 2009|Lenalidomide 25mg by mouth (PO) daily on Days 1 to 21 in each 28 day cycle
399257|NCT00622284|B3|Baseline|Total|Total of all reporting groups
399258|NCT00622284|B2|Baseline|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399259|NCT00622284|B1|Baseline|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399260|NCT00622284|P2|Participant Flow|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399261|NCT00622284|P1|Participant Flow|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399262|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399263|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399264|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399265|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399266|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399267|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399268|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399269|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399270|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399271|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399272|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399273|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399274|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399275|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399276|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399277|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399278|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399279|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399280|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399281|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399282|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399283|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399284|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399285|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399286|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399287|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399288|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399289|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399290|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399291|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399292|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399293|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399294|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399295|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399296|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399297|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399298|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399299|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399300|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399301|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399302|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399303|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399304|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399305|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399306|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399307|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399308|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399309|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399310|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399311|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399312|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399313|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399314|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399315|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399316|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399317|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399318|NCT00622284|O2|Outcome|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399319|NCT00622284|O1|Outcome|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399320|NCT00622284|E2|Reported Event|Glimepiride|Patients randomized to receive Glimepiride 1-4mg and metformin
399321|NCT00622284|E1|Reported Event|Linagliptin|Patients randomized to receive Linagliptin 5mg and metformin
399322|NCT00622167|B1|Baseline|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
399323|NCT00622167|P1|Participant Flow|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
399324|NCT00622167|O1|Outcome|Plaque Characteristics|Characteristics include plaque cross-sectional diameter, area measurements, plaque volume, and plaque morphology.
399325|NCT00622167|E1|Reported Event|IBIVUS and DSCT|All patients will receive integrated backscatter IVUS and dual source CT.
399326|NCT00621985|B1|Baseline|Experimental Group|These subjects were admitted twice, once while on baseline hydrocortisone and once on dexamethasone.
399327|NCT00621985|P1|Participant Flow|Experimental|Baseline hydrocortisone was given at a dose determined by the subject's primary endocrinologist and was given either 2 or 3 times per day as per their home regimen. Experimental therapy with nocturnal dexamethasone given at a dose equivalent to 1/50th of the total daily hydrocortisone dose. This dose was given at 10 PM for three nights with the admission to the hospital occurring on the 3rd day prior to the 3rd evening dose.
399328|NCT00621985|O2|Outcome|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
399329|NCT00621985|O1|Outcome|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
399330|NCT00621985|E2|Reported Event|Hydrocortisone Admission|This is the first admission of the protocol during which the subject received hydrocortisone.
399331|NCT00621985|E1|Reported Event|Dexamethasone Admission|This is the second admission of the protocol during which the subject received dexamethasone.
399332|NCT00621959|B3|Baseline|Total|Total of all reporting groups
399333|NCT00621959|B2|Baseline|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
399334|NCT00621959|B1|Baseline|Placebo|Matched placebo tablets once daily
399335|NCT00621959|P2|Participant Flow|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
399336|NCT00621959|P1|Participant Flow|Placebo|Matched placebo tablets once daily
399337|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
399338|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
399339|NCT00621959|O2|Outcome|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
399340|NCT00621959|O1|Outcome|Placebo|Matched placebo tablets once daily
399341|NCT00621959|E2|Reported Event|LCTZ|5 mg levocetirizine dihydrochloride tablet once daily
399342|NCT00621959|E1|Reported Event|Placebo|Matched placebo tablets once daily
399343|NCT00621946|B3|Baseline|Total|Total of all reporting groups
399344|NCT00621946|B2|Baseline|Placebo|Placebo Matching Escitalopram taken orally daily.
399345|NCT00621946|B1|Baseline|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399346|NCT00621946|P2|Participant Flow|Matching Placebo|Placebo Matching Escitalopram taken orally daily (for a 12-week duration).
399347|NCT00621946|P1|Participant Flow|Escitalopram|Once daily oral administration (for a 12-week duration) of 10 mg escitalopram tablets with an increase to 20 mg in those with a less than 30% decrease in HAM-D scores at week 4.
399348|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
399349|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399350|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
399351|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399352|NCT00621946|O2|Outcome|Matching Placebo|Placebo Matching Escitalopram taken orally daily.
399353|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399354|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
399355|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399356|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
399357|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399358|NCT00621946|O2|Outcome|Placebo|Placebo Matching Escitalopram taken orally daily.
399359|NCT00621946|O1|Outcome|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399360|NCT00621946|E2|Reported Event|Placebo|Placebo Matching Escitalopram taken orally daily.
399361|NCT00621946|E1|Reported Event|Escitalopram|Active Escitalopram (A SSRI) taken orally in 10mg or 20mg doses daily.
399362|NCT00621933|B1|Baseline|All Patients|All patients receiving cataract surgery
399363|NCT00621933|P1|Participant Flow|All Patients|All patients receiving cataract surgery
399364|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
399365|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
399366|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
399367|NCT00621933|O1|Outcome|All Patients|All patients receiving cataract surgery
399368|NCT00621933|E1|Reported Event|All Patients|All patients receiving cataract surgery
399369|NCT00621855|B6|Baseline|Total|Total of all reporting groups
399370|NCT00621855|B5|Baseline|Placebo|26 week blinded treatment
399371|NCT00621855|B4|Baseline|150mg Dabigatran Etexilate|26 week blinded treatment
399372|NCT00621855|B3|Baseline|110mg Dabigatran Etexilate|26 week blinded treatment
399373|NCT00621855|B2|Baseline|75mg Dabigatran Etexilate|26 week blinded treatment
399374|NCT00621855|B1|Baseline|50mg Dabigatran Etexilate|26 week blinded treatment
399375|NCT00621855|P5|Participant Flow|Placebo|26 week blinded treatment
399376|NCT00621855|P4|Participant Flow|150mg Dabigatran Etexilate|26 week blinded treatment
399377|NCT00621855|P3|Participant Flow|110mg Dabigatran Etexilate|26 week blinded treatment
399378|NCT00621855|P2|Participant Flow|75mg Dabigatran Etexilate|26 week blinded treatment
399379|NCT00621855|P1|Participant Flow|50mg Dabigatran Etexilate|26 week blinded treatment
399380|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399381|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399382|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399383|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399384|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399385|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399386|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399387|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399388|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399389|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399390|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399391|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399392|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399393|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399394|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399395|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399396|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399397|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399398|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399399|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399400|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399401|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399402|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399403|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399404|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399405|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399406|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399407|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399408|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399409|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399410|NCT00621855|O5|Outcome|Placebo|26 week blinded treatment
399411|NCT00621855|O4|Outcome|150mg Dabigatran Etexilate|26 week blinded treatment
399412|NCT00621855|O3|Outcome|110mg Dabigatran Etexilate|26 week blinded treatment
399413|NCT00621855|O2|Outcome|75mg Dabigatran Etexilate|26 week blinded treatment
399414|NCT00621855|O1|Outcome|50mg Dabigatran Etexilate|26 week blinded treatment
399415|NCT00621855|E5|Reported Event|Placebo|26 week blinded treatment
399416|NCT00621855|E4|Reported Event|150mg Dabigatran Etexilate|26 week blinded treatment
399417|NCT00621855|E3|Reported Event|110mg Dabigatran Etexilate|26 week blinded treatment
399418|NCT00621855|E2|Reported Event|75mg Dabigatran Etexilate|26 week blinded treatment
399419|NCT00621855|E1|Reported Event|50mg Dabigatran Etexilate|26 week blinded treatment
399420|NCT00621842|B1|Baseline|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399421|NCT00621842|P1|Participant Flow|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399422|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399423|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399424|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399425|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399426|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399427|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399428|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399429|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399430|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399431|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399432|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399433|NCT00621842|O1|Outcome|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399434|NCT00621842|E1|Reported Event|Open-label Lamotrigine Treatment|This solitary group received open-label lamotrigine treatment for bipolar depression.
399435|NCT00621777|B3|Baseline|Total|Total of all reporting groups
399436|NCT00621777|B2|Baseline|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
399437|NCT00621777|B1|Baseline|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
399438|NCT00621777|P2|Participant Flow|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
399439|NCT00621777|P1|Participant Flow|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks.~Double-Blind, Placebo-Controlled, Relapse-Prevention Phase:~Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
399440|NCT00621777|O2|Outcome|Placebo|"Placebo: At each weekly study visit from the baseline visit to study week 11,ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the placebo condition will receive placebo pills for 40 weeks."
399441|NCT00621777|O1|Outcome|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year. Varenicline has demonstrated safety when dosed at 1 mg twice per day for up to one year.~Varenicline: At each weekly study visit from the baseline visit to study week 11, ALL subjects will receive a one-week supply of varenicline with instructions on how to take the study medication. Titration is as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 weeks.~In addition, participants who enter the relapse prevention phase and are randomized to the varenicline condition will receive varenicline at the dose used to attain initial abstinence for 40 weeks."
399442|NCT00621777|E3|Reported Event|Placebo|2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52
399473|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399940|NCT00620542|P1|Participant Flow|Rosuvastatin 20 mg|2 week run-in period
399443|NCT00621777|E2|Reported Event|Varenicline|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~2. Double-Blind, Placebo-Controlled, Relapse-Prevention Phase: Participants in the open phase who met criteria for biochemically verified, 7-day, point-prevalence abstinence at wks 11 and 12 were considered to be continuously abstinent for at least 14 days and were randomized to continue varenicline, 1.0 mg twice a day, or switch to identical-appearing placebo for wks 12 through 52"
399444|NCT00621777|E1|Reported Event|Varenicline Open Label (Open Phase)|"Varenicline is a partial agonist at alpha4beta2 nicotinic acetylcholine receptors (nAChRs) and a full agonist at alpha 7 nAChRs that has been shown to be effective for smoking cessation compared with placebo and bupropion, with effects on abstinence rates for up to one year.~1. Open label, smoking cessation phase: At each weekly study visit from the baseline visit to study wk 11, ALL subjects will receive a one-week supply of varenicline as follows: 0.5 mg varenicline per day for 3 days, then 0.5 mg twice per day for 4 days, and then 1 mg twice per day for 11 wks."
399445|NCT00621764|B5|Baseline|Total|Total of all reporting groups
399446|NCT00621764|B4|Baseline|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
399447|NCT00621764|B3|Baseline|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399448|NCT00621764|B2|Baseline|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
399449|NCT00621764|B1|Baseline|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399450|NCT00621764|P4|Participant Flow|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399451|NCT00621764|P3|Participant Flow|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399452|NCT00621764|P2|Participant Flow|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399453|NCT00621764|P1|Participant Flow|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399454|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399455|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399456|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399457|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399458|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399459|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399460|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399461|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399462|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399463|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399464|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399465|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399466|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart.
399467|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399468|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399469|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399470|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399471|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399472|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399474|NCT00621764|O4|Outcome|Hepatitis A/JE-CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399475|NCT00621764|O3|Outcome|JE-CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE-CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399476|NCT00621764|O2|Outcome|Hepatitis A/JE-CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE-CV as second vaccination 28 days apart
399477|NCT00621764|O1|Outcome|JE-CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE-CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399478|NCT00621764|E4|Reported Event|Hepatitis A/JE CV (Group 4)|Toddlers aged 12 to 24 months of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
399479|NCT00621764|E3|Reported Event|JE CV/Hepatitis A (Group 3)|Toddlers aged 12 to 24 months of age received one dose of JE CV as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399480|NCT00621764|E2|Reported Event|Hepatitis A/JE CV (Group 2)|Children aged 2 to 5 years of age received one dose of Hepatitis A as first vaccination and one dose of JE CV as second vaccination 28 days apart
399481|NCT00621764|E1|Reported Event|JE CV/Hepatitis A (Group 1)|Children aged 2 to 5 years of age received one dose of Japanese Encephalitis ChimeriVax™ (JE CV) as first vaccination and one dose of Hepatitis A as second vaccination 28 days apart
399482|NCT00621686|B3|Baseline|Total|Total of all reporting groups
399483|NCT00621686|B2|Baseline|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399484|NCT00621686|B1|Baseline|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399485|NCT00621686|P2|Participant Flow|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399486|NCT00621686|P1|Participant Flow|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399487|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399488|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399489|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399490|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399491|NCT00621686|O2|Outcome|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399492|NCT00621686|O1|Outcome|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399493|NCT00621686|E2|Reported Event|Sorafenib + Bevacizumab /Group B|Patients receive oral sorafenib 200 mg once daily on days 1-14 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399494|NCT00621686|E1|Reported Event|Sorafenib + Bevacizumab/Group A|Patients receive oral sorafenib 400 mg (200 mg twice daily) days 1-5 and 8-12 and 5 mg/kg bevacizumab IV over 30-90 minutes on day 1. Courses repeat every 14 days.
399495|NCT00621621|B4|Baseline|Total|Total of all reporting groups
399496|NCT00621621|B3|Baseline|Subjects Collected From Published Data|Published evidence about the safety and efficacy of using Medtronic’s Freezor® 4 mm CryoCatheter has been reported since the initiation of the CryoFACTS-PAS. The results reported in the literature provide the supplemental data in the same study population as in the PAS and are included to meet the study objectives, as agreed upon with the FDA.
399497|NCT00621621|B2|Baseline|Subjects Consented in the Study Not Ablated|Actual Subjects that were consented in the study that did not meet inclusion criteria.
399498|NCT00621621|B1|Baseline|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
399499|NCT00621621|P2|Participant Flow|External Data Supporting the Study|Data from published reports that include subjects that met inclusion criteria for study and contained data of Heart block.
399500|NCT00621621|P1|Participant Flow|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
399501|NCT00621621|O2|Outcome|External Data Supporting the Study|This arm was taken from pier reviewed published reports that include adult subjects ablated with the Freezor catheter for AVNRT.
399502|NCT00621621|O1|Outcome|Experimental: Freezor Catheter for AVNRT|Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmiacryoablation
399503|NCT00621621|O2|Outcome|External Data Supporting the Study|
399504|NCT00621621|O1|Outcome|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
399505|NCT00621621|E2|Reported Event|External Data Supporting the Study|"Subjects from publication search with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
399941|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399506|NCT00621621|E1|Reported Event|Focal Cryoablation Group|"Subjects with Atrio Ventricular Reentrant Tachycardia (AVNRT)will be treated with cryo (freezing) energy to ablate the slow pathway causing the arrythmia.~Freezor® Cardiac Cryoablation Catheter CryoConsole System: cryoablation"
399507|NCT00621582|B1|Baseline|Tiotropium Bromide|
399508|NCT00621582|P1|Participant Flow|Tiotropium Bromide|
399509|NCT00621582|O1|Outcome|Tiotropium Bromide|
399510|NCT00621582|O1|Outcome|Tiotropium Bromide|
399511|NCT00621582|O1|Outcome|Tiotropium Bromide|
399512|NCT00621582|O1|Outcome|Tiotropium Bromide|
399513|NCT00621582|E1|Reported Event|Tiotropium Bromide|
399514|NCT00621543|B1|Baseline|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
399515|NCT00621543|P1|Participant Flow|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
399516|NCT00621543|O1|Outcome|Single Arm Study|
399517|NCT00621543|O1|Outcome|Single Arm Study|
399518|NCT00621543|E1|Reported Event|Observation- All Subjects|Women choosing intra-uterine contraception after medical abortion.
399519|NCT00621517|B3|Baseline|Total|Total of all reporting groups
399520|NCT00621517|B2|Baseline|Placebo|Participants will receive matching placebo capsule nightly.
399521|NCT00621517|B1|Baseline|Bupropion|Participants will receive 150MG Bupropion nightly.
399522|NCT00621517|P2|Participant Flow|Placebo|Participants will receive matching placebo capsule nightly.
399523|NCT00621517|P1|Participant Flow|Bupropion|Participants will receive 150MG Bupropion nightly.
399524|NCT00621517|O2|Outcome|Placebo|Participants will receive matching placebo capsule nightly.
399525|NCT00621517|O1|Outcome|Bupropion|Participants will receive 150MG Bupropion nightly.
399526|NCT00621517|E2|Reported Event|Placebo|Participants will receive matching placebo capsule nightly.
399527|NCT00621517|E1|Reported Event|Bupropion|Participants will receive 150MG Bupropion nightly.
399528|NCT00621504|B3|Baseline|Total|Total of all reporting groups
399529|NCT00621504|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
399530|NCT00621504|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
399531|NCT00621504|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
399532|NCT00621504|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
399533|NCT00621504|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
399534|NCT00621504|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
399535|NCT00621504|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
399536|NCT00621504|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300-mg IV infusions over 30 minutes, every 12 hours (q12h)
399537|NCT00621348|B4|Baseline|Total|Total of all reporting groups
399538|NCT00621348|B3|Baseline|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399539|NCT00621348|B2|Baseline|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399540|NCT00621348|B1|Baseline|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399541|NCT00621348|P3|Participant Flow|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399542|NCT00621348|P2|Participant Flow|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399543|NCT00621348|P1|Participant Flow|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399544|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399545|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399546|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399547|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399548|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399549|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399550|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399551|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399552|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399553|NCT00621348|O3|Outcome|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399554|NCT00621348|O2|Outcome|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399555|NCT00621348|O1|Outcome|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399556|NCT00621348|E3|Reported Event|Hypotonic Saline|N/5 saline in 5% dextrose at standard maintenance rate
399557|NCT00621348|E2|Reported Event|Fluid Restriction Group|Reduced volume (2/3 maintenance rate) of N/5 saline in 5% dextrose
399558|NCT00621348|E1|Reported Event|Dextrose Normal Saline|Normal saline in 5% dextrose at standard maintenance rate
399559|NCT00621322|B7|Baseline|Total|Total of all reporting groups
399560|NCT00621322|B6|Baseline|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399698|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399561|NCT00621322|B5|Baseline|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399562|NCT00621322|B4|Baseline|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399563|NCT00621322|B3|Baseline|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399564|NCT00621322|B2|Baseline|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399565|NCT00621322|B1|Baseline|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399566|NCT00621322|P6|Participant Flow|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399567|NCT00621322|P5|Participant Flow|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399568|NCT00621322|P4|Participant Flow|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399569|NCT00621322|P3|Participant Flow|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399570|NCT00621322|P2|Participant Flow|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399571|NCT00621322|P1|Participant Flow|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399572|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399573|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399574|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399575|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399576|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399577|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399578|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399579|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399580|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399581|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399582|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399699|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
405612|NCT00606905|B3|Baseline|Total|Total of all reporting groups
399583|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399584|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399585|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399586|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399587|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399588|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399589|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399590|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399591|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399592|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399593|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399594|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399595|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399596|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399597|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399598|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399599|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399600|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399601|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399602|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399603|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399604|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399700|NCT00621192|E4|Reported Event|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399701|NCT00621192|E3|Reported Event|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399605|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399606|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399607|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399608|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399609|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399610|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399611|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399612|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399613|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399614|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399615|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399616|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399617|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399618|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399619|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399620|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399621|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399622|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399623|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399624|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399625|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399626|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399702|NCT00621192|E2|Reported Event|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399703|NCT00621192|E1|Reported Event|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399627|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399628|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399629|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399630|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399631|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399632|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399633|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399634|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399635|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399636|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399637|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399638|NCT00621322|O6|Outcome|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399639|NCT00621322|O5|Outcome|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399640|NCT00621322|O4|Outcome|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399641|NCT00621322|O3|Outcome|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399642|NCT00621322|O2|Outcome|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399643|NCT00621322|O1|Outcome|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399644|NCT00621322|E6|Reported Event|GSK692342_F4D2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 2 (F4D2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399645|NCT00621322|E5|Reported Event|GSK692342_F4D1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 4 dosage 1 (F4D1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399646|NCT00621322|E4|Reported Event|GSK692342_F3 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 3, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399647|NCT00621322|E3|Reported Event|GSK692342_F2 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the adjuvanted GSK692342 vaccine formulation 2 (F2), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399648|NCT00621322|E2|Reported Event|GSK692342_F1 Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the non-adjuvanted GSK692342 vaccine formulation 1 (F1), at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399704|NCT00621153|B3|Baseline|Total|Total of all reporting groups
399705|NCT00621153|B2|Baseline|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
399649|NCT00621322|E1|Reported Event|Control Group|Healthy adults between and including 18 to 45 years of age at the time of first vaccination, who received 2 doses of the control GSK Biologicals` AS01B adjuvanted system, at Day 0, intramuscularly in the non-dominant arm and at Day 30, intramuscularly in the dominant arm.
399650|NCT00621296|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
399651|NCT00621296|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
399652|NCT00621296|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
399653|NCT00621296|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 24 weeks Other Name: Telaprevir
399654|NCT00621257|B6|Baseline|Total|Total of all reporting groups
399655|NCT00621257|B5|Baseline|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
399656|NCT00621257|B4|Baseline|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
399657|NCT00621257|B3|Baseline|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
399658|NCT00621257|B2|Baseline|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
399659|NCT00621257|B1|Baseline|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
399660|NCT00621257|P5|Participant Flow|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
399661|NCT00621257|P4|Participant Flow|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
399662|NCT00621257|P3|Participant Flow|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
399663|NCT00621257|P2|Participant Flow|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
399664|NCT00621257|P1|Participant Flow|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
399665|NCT00621257|O2|Outcome|Maintenance B|"2,000 IU/day of vitamin D2 orally from November 1 to April 30, and 1,000 IU/day of vitamin D2 orally for the remainder of the year over 2 years~ergocalciferol: 8000 units/ml"
399666|NCT00621257|O1|Outcome|Maintenance A|"400 IU/day of vitamin D2 orally over 2 years (control arm)~ergocalciferol: 8000 units/ml"
399667|NCT00621257|O3|Outcome|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
399668|NCT00621257|O2|Outcome|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
399669|NCT00621257|O1|Outcome|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
399670|NCT00621257|E5|Reported Event|Maintenance B|"1,000 IU of oral vitamin D2 per day from May to October and 2,000 IU of oral vitamin D2 per day of oral vitamin D2 per day from November to April~ergocalciferol 8000 IU/ml"
399671|NCT00621257|E4|Reported Event|Maintenance A|"400 IU per day of oral vitamin D2~ergocalciferol 8000 IU/ml"
399672|NCT00621257|E3|Reported Event|Treatment C|"50,000 IU of vitamin D2 once a week orally for 6 weeks~ergocalciferol: 8000 units/ml"
399673|NCT00621257|E2|Reported Event|Treatment B|"2,000 IU/day of vitamin D3 orally for 6 weeks~Cholecalciferol: 400 units per drop"
399674|NCT00621257|E1|Reported Event|Treatment A|"2,000 IU/day of vitamin D2 orally for 6 weeks (control arm)~ergocalciferol: 8000 units/ml"
399675|NCT00621192|B5|Baseline|Total|Total of all reporting groups
399676|NCT00621192|B4|Baseline|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399677|NCT00621192|B3|Baseline|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399678|NCT00621192|B2|Baseline|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399679|NCT00621192|B1|Baseline|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399680|NCT00621192|P4|Participant Flow|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399681|NCT00621192|P3|Participant Flow|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399682|NCT00621192|P2|Participant Flow|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399683|NCT00621192|P1|Participant Flow|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399684|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399685|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399686|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399687|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399688|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399689|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399690|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399691|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399692|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399693|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399694|NCT00621192|O2|Outcome|2. GA <32 Wks; PNA 91days ≥ 2Wks|Group 2: GA at birth below 32 weeks - PNA ≥ 2 weeks and < 91 days
399695|NCT00621192|O1|Outcome|1. GA <32 Wks; PNA<2 Wks|Group 1: GA at birth below 32 weeks - PNA < 2 weeks;
399696|NCT00621192|O4|Outcome|4. GA ≥32 Wks; PNA 91 Days ≥ 2 Wks|Group 4: GA at birth 32 weeks or older - PNA ≥ 2 weeks and < 91 days.
399697|NCT00621192|O3|Outcome|3. GA ≥ 32 Wks; PNA <2 Wks|Group 3: GA at birth 32 weeks or older - PNA < 2 weeks;
399706|NCT00621153|B1|Baseline|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
399707|NCT00621153|P2|Participant Flow|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
399708|NCT00621153|P1|Participant Flow|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
399709|NCT00621153|O2|Outcome|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
399710|NCT00621153|O1|Outcome|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
399711|NCT00621153|E2|Reported Event|Candesartan Cilexetil Monotherapy|candesartan cilexetil monotherapy
399712|NCT00621153|E1|Reported Event|Candesartan Cilexetil/Hydroclorozide Combination Therapy|candesartan cilexetil/Hydroclorozide combination therapy
399713|NCT00621140|B3|Baseline|Total|Total of all reporting groups
399714|NCT00621140|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399715|NCT00621140|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
399716|NCT00621140|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399717|NCT00621140|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
399718|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399719|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399720|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399721|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399722|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399723|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399724|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399725|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399726|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399727|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399728|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399729|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399730|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399731|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399732|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399733|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399734|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399735|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399736|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399737|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399738|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399739|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399740|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399741|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399742|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399743|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399744|NCT00621140|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399745|NCT00621140|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
399746|NCT00621140|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
399747|NCT00621140|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
399748|NCT00621049|B3|Baseline|Total|Total of all reporting groups
399749|NCT00621049|B2|Baseline|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399750|NCT00621049|B1|Baseline|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399751|NCT00621049|P2|Participant Flow|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399752|NCT00621049|P1|Participant Flow|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399753|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399754|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399755|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399756|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399757|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399758|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399759|NCT00621049|O2|Outcome|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399760|NCT00621049|O1|Outcome|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399761|NCT00621049|E2|Reported Event|Docetaxel and Carboplatin|"Docetaxel/Carboplatin: Adjuvant Treatment Cohort B:~Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1~Docetaxel should be administered before carboplatin.~Treatment cycle = 21 days. Patients in Cohort B will complete 4 cycles of treatment."
399762|NCT00621049|E1|Reported Event|Docetaxel/Carboplatin/Bevacizumab/Erlotinib|"Docetaxel/Carboplatin/Bevacizumab/Erlotinib: Docetaxel 75mg/m2 IV D1 Carboplatin AUC=6 IV D1 Bevacizumab 15mg/kg IV D1~Docetaxel should be administered before carboplatin.~After completion of four cycles of treatment, patients in Cohort A will then proceed with Maintenance treatment defined as follows:~Maintenance Treatment for patients in Cohort A:~Bevacizumab 15mg/kg IV D1 Erlotinib 150mg PO daily~Treatment cycle = 21 days. Patients will complete 8 cycles (24 weeks) of maintenance therapy unless there is evidence of disease recurrence or unacceptable toxicity."
399763|NCT00621023|B1|Baseline|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399764|NCT00621023|P1|Participant Flow|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399765|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399766|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399802|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
399942|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399767|NCT00621023|O1|Outcome|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399768|NCT00621023|E1|Reported Event|All Participants|"Drug: Decitabine, Arsenic Trioxide and Ascorbic Acid for MDS~Decitabine, Arsenic Trioxide and Ascorbic Acid : Subjects receive decitabine 20 mg/m2 IV over one hour for days1-5 of each cycle, and arsenic trioxide 0.25 mg/kg IV for days 1-5 of cycle 1 followed by 0.25 mg/kg twice weekly (Mon-Thursday or Tues-Fri) for all remaining cycles. Patients will have transfusion and supportive care therapy administered per the treating physician's discretion. Patients with a response after 4 cycles of therapy may choose to continue on two more cycles of decitabine with arsenic and ascorbic acid given only during the first week of those two additional cycles."
399769|NCT00620854|B7|Baseline|Total|Total of all reporting groups
399770|NCT00620854|B6|Baseline|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399771|NCT00620854|B5|Baseline|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399772|NCT00620854|B4|Baseline|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399773|NCT00620854|B3|Baseline|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399774|NCT00620854|B2|Baseline|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399775|NCT00620854|B1|Baseline|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399776|NCT00620854|P6|Participant Flow|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399777|NCT00620854|P5|Participant Flow|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399778|NCT00620854|P4|Participant Flow|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399779|NCT00620854|P3|Participant Flow|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399780|NCT00620854|P2|Participant Flow|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399781|NCT00620854|P1|Participant Flow|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399782|NCT00620854|O3|Outcome|Fortical®|Fortical nasal spray (200 IU)
399783|NCT00620854|O2|Outcome|rsCTB|Oral rsCT (200 micrograms)
399784|NCT00620854|O1|Outcome|rsCT A|Oral rsCT (150 micrograms)
399785|NCT00620854|E6|Reported Event|Fortical Then rsCTB Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399786|NCT00620854|E5|Reported Event|Fortical Then rsCTA Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399787|NCT00620854|E4|Reported Event|rsCTB Then Fortical Then rsCTA|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399788|NCT00620854|E3|Reported Event|rsCTB Then rsCTA Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399789|NCT00620854|E2|Reported Event|rsCTA Then Fortical Then rsCTB|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399790|NCT00620854|E1|Reported Event|rsCTA Then rsCTB Then Fortical|single dose rsCTA tablets (150 micrograms), single dose rsCTB tablets (200 micrograms), Fortical nasal spray (200 IU)
399791|NCT00620828|B3|Baseline|Total|Total of all reporting groups
399792|NCT00620828|B2|Baseline|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
399793|NCT00620828|B1|Baseline|Control Group|Subjects receive intra-op saline injection per protocol
399794|NCT00620828|P2|Participant Flow|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
399795|NCT00620828|P1|Participant Flow|Control Group|Subjects receive intra-op saline injection per protocol
399796|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
399797|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
399798|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
399799|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
399800|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
399801|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
399803|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
399804|NCT00620828|O2|Outcome|Control Group|Participants received a 20 mL posterior capsular injection of saline before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of saline.
399805|NCT00620828|O1|Outcome|Block Group|Participants received a 20 mL posterior capsular injection of ropivicaine before cementation of final components. The posterior capsule of the knee was divided into 4 quadrants, each receiving a 5 mL injection of ropivicaine.
399806|NCT00620828|E2|Reported Event|Block Group|Subjects receive intra-op Ropivicaine 0.5% injection per protocol
399807|NCT00620828|E1|Reported Event|Control Group|Subjects receive intra-op saline injection per protocol
399808|NCT00620815|B4|Baseline|Total|Total of all reporting groups
399809|NCT00620815|B3|Baseline|A/S-A|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399810|NCT00620815|B2|Baseline|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399811|NCT00620815|B1|Baseline|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399812|NCT00620815|P3|Participant Flow|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399813|NCT00620815|P2|Participant Flow|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399814|NCT00620815|P1|Participant Flow|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399815|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399816|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399817|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399818|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399819|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399820|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399821|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399822|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399823|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399824|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399825|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399826|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399827|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399828|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399829|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399830|NCT00620815|O6|Outcome|A/S-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
399831|NCT00620815|O5|Outcome|A/P-T: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
399832|NCT00620815|O4|Outcome|T/P-A: After 2nd Vaccination|Systemic reactions after second vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
405811|NCT00606554|O1|Outcome|Computer-assisted Weaning|intervention arm
399833|NCT00620815|O3|Outcome|A/S-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed 3 to 5 weeks later by Aflunov (A)
399834|NCT00620815|O2|Outcome|A/P-T: After 1st Vaccination|Systemic reactions after first vaccination after one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by tetravalent influenza vaccine (T)
399835|NCT00620815|O1|Outcome|T/P-A: After 1st Vaccination|Systemic reactions after first vaccination after one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed 3 to 5 weeks later by Aflunov (A)
399836|NCT00620815|O3|Outcome|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal(S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399837|NCT00620815|O2|Outcome|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399838|NCT00620815|O1|Outcome|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399839|NCT00620815|O6|Outcome|A/S-A: In Arm Receiving Seasonal Influenza Vaccine (S)|Local reactions after first vaccination in arm receiving seasonal influenza vaccination in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
399840|NCT00620815|O5|Outcome|A/S-A: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) bon day 22
399841|NCT00620815|O4|Outcome|A/P-T: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving Placebo in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
399842|NCT00620815|O3|Outcome|A/P-T: In Arm Receiving Aflunov (A)|Local reactions after first vaccination in arm receiving Aflunov in group receiving one dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine(T) on day 22
399843|NCT00620815|O2|Outcome|T/P-A: In Arm Receiving Placebo (P)|Local reactions after first vaccination in arm receiving placebo in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
399844|NCT00620815|O1|Outcome|T/P-A: In Arm Receiving Tetravalent Vaccine (T)|Local reactions after first vaccination in arm receiving tetravalent influenza vaccine in group receiving one dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
399845|NCT00620815|O3|Outcome|A/S-A|One dose of Aflunov (A) and concomitantly, but in a different arm, one dose of licensed seasonal vaccine (S) on day 1, followed Aflunov (A) on day 22
399846|NCT00620815|O2|Outcome|A/P-T|One dose of the Aflunov (A) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Tetravalent influenza vaccine (T) on day 22
399847|NCT00620815|O1|Outcome|T/P-A|One dose of the tetravalent influenza vaccine (T) and concomitantly, but in a different arm, one dose of placebo (P) on day 1, followed by Aflunov (A) on day 22
399848|NCT00620815|E3|Reported Event|A/S-A|one dose of the Aflunov (A, A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, one dose of licensed seasonal (S) vaccine, on study day 1, followed by Aflunov (A), on study day 22
399849|NCT00620815|E2|Reported Event|A/P-T|one dose of the Aflunov (A; A/H5N1) avian influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by the tetravalent (T) influenza vaccine, on study day 22
399850|NCT00620815|E1|Reported Event|T/P-A|one dose of the tetravalent (T) influenza vaccine administered concomitantly, in a different arm, with one dose of the placebo (P) control, on study day 1, followed by Aflunov, on study day 22
399851|NCT00620776|B3|Baseline|Total|Total of all reporting groups
399852|NCT00620776|B2|Baseline|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399853|NCT00620776|B1|Baseline|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399854|NCT00620776|P2|Participant Flow|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399855|NCT00620776|P1|Participant Flow|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399856|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399857|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399858|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399859|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399860|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399861|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399862|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399863|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399864|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399865|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399866|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399867|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399868|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399869|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399870|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399871|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399872|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399873|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399874|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399875|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399876|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399877|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399878|NCT00620776|O2|Outcome|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399879|NCT00620776|O1|Outcome|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399880|NCT00620776|E2|Reported Event|Medication Alone|Patients received Venlafaxine XR (75-225 mg/d) alone as treatment for GAD over a period of 6 months.
399881|NCT00620776|E1|Reported Event|Combined Treatment|Patients received Venlafaxine XR (75-225 mg/d) plus 12 weeks of CBT (one 1 to 1.5 hour session per week) for GAD over a period of 6 months.
399882|NCT00620763|B1|Baseline|Entire Study Population|Dietary Intervention: Crossover design, High meat and high potential renal acid load (high PRAL) diet and low meat and low potential renal acid load (low PRAL) diet, consumed in random order.
399883|NCT00620763|P2|Participant Flow|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
399884|NCT00620763|P1|Participant Flow|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
399885|NCT00620763|O2|Outcome|Low Meat - Low Potential Renal Acid Load|Low meat and low potential renal acid load (low PRAL) diet in either the first or second intervention period
399886|NCT00620763|O1|Outcome|High Meat - High Potential Renal Acid Load|High meat and high potential renal acid load (high PRAL) diet in either the first or second intervention period
399887|NCT00620763|E2|Reported Event|Low Meat & Low Potential Renal Acid Load - First|Low meat and low potential renal acid load (low PRAL) followed by High meat and high potential renal acid load (high PRAL) diet.
399888|NCT00620763|E1|Reported Event|High Meat & High Potential Renal Acid Load - First|High meat and high potential renal acid load (high PRAL) diet followed by low meat and low potential renal acid load (low PRAL) diet.
399889|NCT00620750|B1|Baseline|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
399890|NCT00620750|P1|Participant Flow|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
399891|NCT00620750|O1|Outcome|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
399892|NCT00620750|E1|Reported Event|Extended Release Injectable Naltrexone|This was a single arm trial, with no formal control group. The treatment administered was a single 380-mg extended-release naltrexone (Vivitrol)dose injected intramuscularly into the upper, outer gluteus,alternating sides monthly. Medication injection was performed by physicians per package insert guidelines. A final Month 4 visit assessed treatment outcomes and satisfaction. Patients interested in further extended-release naltrexone treatment at study end were referred to a related 12-month extended-release naltrexone extension study, and all patients were able to continue in primary care.
399939|NCT00620542|P2|Participant Flow|Atorvastatin 40 mg|2 week run-in period
407038|NCT00603590|B3|Baseline|Total|Total of all reporting groups
399893|NCT00620711|B1|Baseline|Preter Infnats With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms. Criteria include Sentinel evnet , Low Apgar, pH less than 7, Neonatal encephalopathy with no other cause and need for mechanical ventialtion~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
399894|NCT00620711|P1|Participant Flow|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
399895|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
399896|NCT00620711|O1|Outcome|Group 1 Cool- Cap Applied While Maintaining Rectal Temp|Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.
399897|NCT00620711|E1|Reported Event|Preterm Infants With HIE|"Babies that meet criteria will be offered participation in feasibility trial, there are no other arms.~Olympic Cool Cap: Olympic Cool Cap will be applied to infants 32-35 weeks gestation who meet criteria for HIE."
399898|NCT00620698|B1|Baseline|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399899|NCT00620698|P1|Participant Flow|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399900|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399901|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399902|NCT00620698|O1|Outcome|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399903|NCT00620698|E1|Reported Event|ALS Patients|Patients with clinically established amyotrophic lateral sclerosis
399904|NCT00620659|B1|Baseline|All Randomized Participants|All participants randomized in study
399905|NCT00620659|P6|Participant Flow|Modafinil/Placebo/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399906|NCT00620659|P5|Participant Flow|Placebo/MK0249/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399907|NCT00620659|P4|Participant Flow|MK0249/Modafinil/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399908|NCT00620659|P3|Participant Flow|Modafinil/MK0249/Placebo|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399909|NCT00620659|P2|Participant Flow|Placebo/Modafinil/MK0249|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399910|NCT00620659|P1|Participant Flow|MK0249/Placebo/Modafinil|"Eligible participants were equally randomized to 1 of 6 treatment sequences: MK0249/Placebo/Modafinil, Placebo/Modafinil/MK0249, Modafinil/MK0249/Placebo, MK0249/Modafinil/Placebo, Placebo/MK0249/Modafinil, Modafinil/Placebo/MK0249. The dose of the MK0249 was determined according to a predefined adaptive algorithm. Treatment period was determined by the sequence to which the participant was randomized. Each treatment period was followed by a 7-day placebo washout period.~MK0249 was provided as 1 mg and 5 mg tablets. Modafinil was provided as 100 mg tablets. Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet."
399911|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
399912|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
399913|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
399914|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
399915|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
399916|NCT00620659|O1|Outcome|MK0249 Top 2 Doses Pooled|"The top 2 doses (the two doses to which most patients were adaptively assigned) were 10 mg and 12 mg.~There were 74 participants who received MK0249 10 and 12 mg over 3 periods (25, 22, and 27 participants for Periods 1, 2, and 3 respectively)."
399917|NCT00620659|O2|Outcome|Modafinil 200 mg|There were 106 participants who received Modafinil 200 mg over 3 periods (40, 36, and 30 participants for Periods 1, 2, and 3 respectively).
399918|NCT00620659|O1|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
399919|NCT00620659|O2|Outcome|MK0249 Mode Dose|"The Mode dose (the dose to which most patients were adaptively assigned) of MK0249 was 10 mg.~There were 39 participants who received MK0249 10 mg (Mode Dose) over 3 periods (14, 12, and 13 participants for Periods 1, 2, and 3 respectively)."
399920|NCT00620659|O1|Outcome|Placebo|There were 116 participants who received placebo over 3 periods (42, 38, and 36 participants for Periods 1, 2, and 3 respectively).
399921|NCT00620659|E6|Reported Event|Modafinil|Modafinil was provided as 100 mg tablets.
399922|NCT00620659|E5|Reported Event|MK0249 12 mg|MK0249 was provided as 1 mg and 5 mg tablets.
399923|NCT00620659|E4|Reported Event|MK0249 10 mg|MK0249 was provided as 1 mg and 5 mg tablets.
399924|NCT00620659|E3|Reported Event|MK0249 8 mg|MK0249 was provided as 1 mg and 5 mg tablets.
399925|NCT00620659|E2|Reported Event|MK0249 5 mg|MK0249 was provided as 1 mg and 5 mg tablets.
399926|NCT00620659|E1|Reported Event|Placebo|Matching placebo tablets were provided for the MK0249 1 and 5 mg tablets and for the modafinil 100 mg tablet.
399927|NCT00620555|B1|Baseline|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399928|NCT00620555|P1|Participant Flow|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399929|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399930|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399931|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399932|NCT00620555|O1|Outcome|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399933|NCT00620555|E1|Reported Event|Gabapentin|Pediatric participants received gabapentin three times daily for 52 weeks. Participants aged 3 to 12 years received oral solution (250 mg/5 mL) at the dose calculated based on their body weight; 40 mg/kg/day for 3 to 4 years old and 25 to 35 mg/kg/day for 5 to 12 years old but not exceeding 1800 mg per day. Participants aged 13 to 15 years received gabapentin tablet at the dose of 1200 or 1800 mg/day. The dose was adjusted within the range of maintenance doses. Gabapentin could be increased if necessary with the maximum dose of 50 mg/kg/day for participants aged 3 to 12 years; All participants could receive gabapentin tablet not exceeding 2400 mg per day.
399934|NCT00620542|B3|Baseline|Total|Total of all reporting groups
399935|NCT00620542|B2|Baseline|Atorvastatin 80 mg|2 years
399936|NCT00620542|B1|Baseline|Rosuvastatin 40 mg|2 years
399937|NCT00620542|P4|Participant Flow|Atorvastatin 80 mg|2 year core study
399938|NCT00620542|P3|Participant Flow|Rosuvastatin 40 mg|2 year core study
399943|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399944|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399945|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399946|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399947|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399948|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399949|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399950|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399951|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399952|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399953|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399954|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399955|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399956|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399957|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399958|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399959|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399960|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399961|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399962|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399963|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399964|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399965|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399966|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399967|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399968|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399969|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399970|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399971|NCT00620542|O2|Outcome|Atorvastatin 80 mg|Part B: Atorvastatin 80 mg for core study - 2 years
399972|NCT00620542|O1|Outcome|Rosuvastatin 40 mg|Part B: Rosuvastatin 40 mg for core study - 2 years
399973|NCT00620542|E4|Reported Event|Atorvastatin 80 mg|2 year core study
399974|NCT00620542|E3|Reported Event|Rosuvastatin 40 mg|2 year core study
399975|NCT00620542|E2|Reported Event|Atorvastatin 40 mg|2 week run-in period
399976|NCT00620542|E1|Reported Event|Rosuvastatin 20 mg|2 week run-in period
399977|NCT00620464|B3|Baseline|Total|Total of all reporting groups
399978|NCT00620464|B2|Baseline|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
399979|NCT00620464|B1|Baseline|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
399980|NCT00620464|P2|Participant Flow|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
399981|NCT00620464|P1|Participant Flow|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
399982|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
399983|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
399984|NCT00620464|O2|Outcome|Implanon (Imp)|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
399985|NCT00620464|O1|Outcome|Radiopaque Implanon (ro Imp)|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
399986|NCT00620464|E2|Reported Event|Radiopaque Implanon|The radiopaque rod (Radiopaque Implanon) is similar to the Implanon rod except for the addition of barium sulfate.
400026|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400150|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
399987|NCT00620464|E1|Reported Event|Implanon|"Implanon® (Org 32222) is a single rod contraceptive implant of 4 cm length and 2 mm in diameter. Implanon® contains approximately 68 mg etonogestrel (ENG) (Org 3236, 3-ketodesogestrel) dispersed in a matrix of ethylene vinyl acetate (EVA)copolymer, surrounded by an EVA membrane.~The ENG dose released by Implanon® amounts to about 60-70 μg/day shortly after insertion and decreases to about 40 μg/day at the start of the second year, and to about 25-30 μg/day at the end of the third year."
399988|NCT00620425|B1|Baseline|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
399989|NCT00620425|P1|Participant Flow|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
399990|NCT00620425|O8|Outcome|72 hr Post-dose|Only 3 subjects were required to return on Day 4. Day 4 assessments included a 72 hour assessment for the first and second injections and a 48 hour assessment for the third injection.
399991|NCT00620425|O7|Outcome|48 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399992|NCT00620425|O6|Outcome|24 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399993|NCT00620425|O5|Outcome|8 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399994|NCT00620425|O4|Outcome|4 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399995|NCT00620425|O3|Outcome|1 hr Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399996|NCT00620425|O2|Outcome|All Participants Immediately Post-dose|These are the reactions relative to each injection (total of 3 injections in 18 participants).
399997|NCT00620425|O1|Outcome|All Participants at -15 Min Pre-dose|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
399998|NCT00620425|E1|Reported Event|All Participants|Every participant received SUMAVEL DosePro at time 0, 1 and 25 hrs. Every participant was monitored for the incidence and persistence of bleeding, bruising, swelling and erythema.
399999|NCT00620373|B1|Baseline|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
400000|NCT00620373|P1|Participant Flow|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
400001|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
400002|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
400003|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
400004|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
400005|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
400006|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
400007|NCT00620373|O1|Outcome|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-mBQ (20-mCi) Technetium (99mTc) sestamibi injection.
400008|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
400009|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
400010|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
400011|NCT00620373|O3|Outcome|Both Mammography and Gamma Imaging|For this reporting arm, the interpretation and analysis was done with both mammography and gamma images together.
400012|NCT00620373|O2|Outcome|Gamma Imaging|For this reporting arm, the interpretation and analysis was done with gamma imaging only.
400013|NCT00620373|O1|Outcome|Mammography Only|For this reporting arm, the interpretation and analysis was done with mammography only.
400014|NCT00620373|E1|Reported Event|Mammography and Molecular Breast Imaging|Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ)(20-mCi) Technetium (99mTc) sestamibi injection.
400015|NCT00620282|B4|Baseline|Total|Total of all reporting groups
400016|NCT00620282|B3|Baseline|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400017|NCT00620282|B2|Baseline|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400018|NCT00620282|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400019|NCT00620282|P3|Participant Flow|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400020|NCT00620282|P2|Participant Flow|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400021|NCT00620282|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400022|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400023|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400024|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400025|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400637|NCT00619060|E2|Reported Event|Placebo Forearm (Only)|Forearms receiving the Placebo
400027|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400028|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400029|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400030|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400031|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400032|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400033|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400034|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400035|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400036|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400037|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400038|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400039|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400040|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400041|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400042|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400043|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400044|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400045|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400046|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400047|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400048|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400049|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400050|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400051|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400052|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400053|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400054|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400055|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400056|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400057|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400058|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400059|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400060|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400061|NCT00620282|O3|Outcome|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400062|NCT00620282|O2|Outcome|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400063|NCT00620282|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400064|NCT00620282|E3|Reported Event|Glimepiride|Glimepiride 4 mg administered orally, once-daily, open-label, weeks 0-12
400065|NCT00620282|E2|Reported Event|Placebo|Placebo administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400066|NCT00620282|E1|Reported Event|Lira 1.8|Liraglutide 1.8 mg administered subcutaneously, once-daily, weeks 0-12 (100 uL/day, week 1; 200 uL/day, week 2; 300 uL/day, week 3-12)
400067|NCT00620126|B3|Baseline|Total|Total of all reporting groups
400068|NCT00620126|B2|Baseline|Control|Best Available Care
400069|NCT00620126|B1|Baseline|Intervention|UC Home Automated Telemanagement
400101|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400151|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400959|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400070|NCT00620126|P2|Participant Flow|Best Available Care|The standard of care for participants in this study is modeled after the standard of care at our institution, and based on current evidence-based guidelines including comprehensive assessment, a guideline-concordant therapy plan, scheduled and as needed clinic visits, scheduled and as needed telephone calls, and administration of educational fact sheets about disease-specific topics when appropriate. We expanded the care received by controls to make the groups more comparable. First, we provided the control group with all currently available educational fact sheets from the Crohn’s and Colitis Foundation at the time of group allocation. Second, we provided the control group with individualized written action plans at the time of group assignment without reinforcement.
400071|NCT00620126|P1|Participant Flow|UC Home Automated Telemanagement|The UC HAT home unit consists of a netbook computer and an electronic weight scale. Participants answer questions regarding symptoms, side effects, adherence, and receive disease-specific education using the home unit. The home unit automatically transmits the results to the decision support server after each self-testing session. Participants completed self-testing weekly. Updated action plans are automatically transmitted to participant home units if certain criteria are met. If certain clinical conditions are met, email alerts are sent to the nurse coordinator. The coordinator reviews the information and if necessary consults the medical provider and the participant for management changes.
400072|NCT00620126|O2|Outcome|Control|Best Available Care
400073|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
400074|NCT00620126|O2|Outcome|Control|Best Available Care
400075|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
400076|NCT00620126|O2|Outcome|Control|Best Available Care
400077|NCT00620126|O1|Outcome|Intervention|UC Home Automated Telemanagement
400078|NCT00620126|E2|Reported Event|Control|Best Available Care
400079|NCT00620126|E1|Reported Event|Intervention|UC Home Automated Telemanagement
400080|NCT00620074|B1|Baseline|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
400081|NCT00620074|P1|Participant Flow|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
400082|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
400083|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
400084|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
400085|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
400086|NCT00620074|O1|Outcome|Anidulalfungin and Voriconazole|Anidulafungin and voriconazole in combination followed by monotherapy.
400087|NCT00620074|E1|Reported Event|Anidulalfungin and Voriconazole|"Voriconazole: subjects with creatinine clearance at least 50 milliliters per minute (ml/min) will receive initial treatment with intravenous (IV) (loading dose of 6 milligrams per kilogram [mg/kg] every 12 hours [Q12h]) followed by maintenance dose of 4 mg/kg Q12h or oral (PO) (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h). Subjects with creatinine clearance <50 ml/min will receive oral Voriconazole (loading dose of 400 mg Q12h followed by maintenance dose of 300 mg Q12h).~Anidulafungin: loading dose of 200 mg once daily (QD) followed by maintenance dose of 100 mg QD for up to a total of 28 days therapy.~Subjects remain on combination therapy for minimum of 14 days and a maximum of 28 days; after combination therapy complete, subjects may remain on a maintenance dose of Voriconazole monotherapy until Day 42."
400088|NCT00620035|B1|Baseline|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400089|NCT00620035|P1|Participant Flow|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400102|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400090|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400091|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400092|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400093|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400094|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400095|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400096|NCT00620035|O1|Outcome|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400097|NCT00620035|E1|Reported Event|Radiopaque Etonogestrel Implant|"The Radiopaque Implant is a single rod contraceptive implant of 4 cm length and 2 mm in diameter which is placed at the inner side of the non-dominant upper-arm about 8-10 cm above the medial epicondyle. The Radiopaque Implant contains approximately 68 mg etonogestrel (ENG) dispersed in a matrix of ethylene vinyl acetate (EVA) copolymer and barium sulfate, surrounded by an EVA membrane. The barium-sulfate provides radio-opacity and allows detection by X-ray.~The ENG dose released from the implant amounts to about 60-70 mcg/day shortly after insertion and decreases to about 40 mcg/day at the start of the second year, and to about 25-30 mcg/day at the end of the third year."
400098|NCT00620022|B1|Baseline|Entire Study Population|The entire study population includes the group of patients who received indacaterol 300 μg in the first treatment period followed by placebo in the second treatment period and the group of patients who received placebo in the first treatment period followed by indacaterol 300 μg in the second treatment period. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400099|NCT00620022|P2|Participant Flow|Placebo Followed by Indacaterol 300 μg|Patients first received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received indacaterol 300 μg delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400100|NCT00620022|P1|Participant Flow|Indacaterol 300 μg Followed by Placebo|Patients first received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. After a 3-week washout period, patients received placebo delivered od via a SDDPI in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400149|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400103|NCT00620022|O2|Outcome|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400104|NCT00620022|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400105|NCT00620022|E2|Reported Event|Placebo|Patients received placebo delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400106|NCT00620022|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning for 3 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
400107|NCT00619970|B4|Baseline|Total|Total of all reporting groups
400108|NCT00619970|B3|Baseline|Children Receiving Placebo|1/3 patients with CAP
400109|NCT00619970|B2|Baseline|Children Receiving Rifaximin|2/3 Patients with CAP
400110|NCT00619970|B1|Baseline|Healthy Control|Healthy controls
400111|NCT00619970|P3|Participant Flow|Children Receiving Placebo|1/3 patients with CAP
400112|NCT00619970|P2|Participant Flow|Children Receiving Rifaximin|2/3 Patients with CAP
400113|NCT00619970|P1|Participant Flow|Healthy Control|Healthy controls
400114|NCT00619970|O2|Outcome|Children Receiving Placebo|1/3 patients with CAP
400115|NCT00619970|O1|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
400116|NCT00619970|O3|Outcome|Children Receiving Placebo|1/3 patients with CAP
400117|NCT00619970|O2|Outcome|Children Receiving Rifaximin|2/3 Patients with CAP
400118|NCT00619970|O1|Outcome|Healthy Control|Healthy controls
400119|NCT00619970|E3|Reported Event|Children Receiving Placebo|1/3 patients with CAP
400120|NCT00619970|E2|Reported Event|Children Receiving Rifaximin|2/3 Patients with CAP
400121|NCT00619970|E1|Reported Event|Healthy Control|Healthy controls
400122|NCT00619957|B3|Baseline|Total|Total of all reporting groups
400123|NCT00619957|B2|Baseline|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400124|NCT00619957|B1|Baseline|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400125|NCT00619957|P2|Participant Flow|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400126|NCT00619957|P1|Participant Flow|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400127|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400128|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400129|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400130|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400131|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400132|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400133|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400134|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400135|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400136|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400137|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400138|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400139|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400140|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400141|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400142|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400143|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400144|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400145|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400146|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400147|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400148|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
401506|NCT00617240|E1|Reported Event|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
400152|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400153|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400154|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400155|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400156|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400157|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400158|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400159|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400160|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400161|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400162|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400163|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400164|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400165|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400166|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400167|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400168|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400169|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400170|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400171|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400172|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400173|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400174|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400175|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400176|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400177|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400178|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400179|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400180|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400181|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400182|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400183|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400184|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400185|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400186|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400187|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400188|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400189|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400190|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400191|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400192|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400193|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400194|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400195|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400196|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400197|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400198|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400199|NCT00619957|O2|Outcome|Risedronate|35 mg risedronate tablet once a week for 2 years followed by an open label with 35 mg risedronate once a week for 2 years
400200|NCT00619957|O1|Outcome|Placebo|Placebo tablet once a week for 2 years followed by once a week Risedronate 35 mg tablet for 2 years
400201|NCT00619957|E4|Reported Event|Risedronate Year 4|Risedronate 35 mg tablet once weekly Years 1 thru 4
400202|NCT00619957|E3|Reported Event|Placebo-Risedronate Year 4|Placebo once weekly Years 1 & 2 followed by risedronate 35 mg once weekly Years 3 & 4
400203|NCT00619957|E2|Reported Event|Risedronate Year 2|Risedronate 35 mg tablet once weekly Years 1 & 2
400204|NCT00619957|E1|Reported Event|Placebo Year 2|Placebo tablet once weekly Years 1 & 2
400205|NCT00619918|B3|Baseline|Total|Total of all reporting groups
400206|NCT00619918|B2|Baseline|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400207|NCT00619918|B1|Baseline|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400208|NCT00619918|P2|Participant Flow|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400209|NCT00619918|P1|Participant Flow|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400210|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400211|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400212|NCT00619918|O2|Outcome|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400213|NCT00619918|O1|Outcome|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400214|NCT00619918|E2|Reported Event|Normal Saline|"0.9% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400215|NCT00619918|E1|Reported Event|Hypertonic Saline|"3% NaCl, 4 ml, via updraft wall nebulizer:~In ED: every 20 minutes up to 3 doses~In Inpatient: every 8 hours until discharge"
400216|NCT00619892|B3|Baseline|Total|Total of all reporting groups
400217|NCT00619892|B2|Baseline|Placebo|Placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
400218|NCT00619892|B1|Baseline|Quetiapine|Quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
400219|NCT00619892|P2|Participant Flow|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
400220|NCT00619892|P1|Participant Flow|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
400221|NCT00619892|O2|Outcome|Placebo|"Subjects received identical-appearing placebo tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication."
400222|NCT00619892|O1|Outcome|Quetiapine XR|"Our target daily dose for quetiapine XR was 200 mg/day. The detailed quetiapine XR dosing guidelines were as follows: 50 mg 1 tab po at HS × 3 days, then, if 50 mg tolerated, increase to 50 mg 2 tabs at HS × 4 days; at the beginning of week 2, if the last dose was tolerated increase to 50 mg 3 tabs at HS × 3 days, then, if 150 mg tolerated, increase to 4 tabs at HS; at the beginning of week 3, if no efficacy & the 200 mg dose was well tolerated, increase to one 300 mg tab at HS-otherwise remain at 200 mg one tab at HS; at week 4 if still no improvement, & 300 mg was tolerable, increase to 200 mg tablet 2 at HS. From the beginning of week 5 to the end of the trial, quetiapine XR doses were held. We used quetiapine XR tablets provided by Astra Zeneca (50, 200, and 300 mg designations).~quetiapine XR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg."
400223|NCT00619892|O2|Outcome|Placebo|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
400224|NCT00619892|O1|Outcome|Quetiapine SR|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
400225|NCT00619892|E2|Reported Event|Placebo Group|placebo: Subjects will receive daily dosing at night with caplets matching the appearance of the active drug. However, caplets will not contain any active medication.
400226|NCT00619892|E1|Reported Event|Quietapine Group|quetiapine SR: Subjects will receive daily dosing at night, with a flexible dosing schedule, 50-400 mg.
400227|NCT00619827|B3|Baseline|Total|Total of all reporting groups
400228|NCT00619827|B2|Baseline|Placebo|Placebo tablet
400229|NCT00619827|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
400230|NCT00619827|P2|Participant Flow|Placebo|Placebo tablet
400231|NCT00619827|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
400232|NCT00619827|O2|Outcome|Placebo|Placebo tablet
400233|NCT00619827|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
400234|NCT00619827|E2|Reported Event|Placebo|Placebo tablet
400235|NCT00619827|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
400236|NCT00619801|B3|Baseline|Total|Total of all reporting groups
400237|NCT00619801|B2|Baseline|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400400|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400238|NCT00619801|B1|Baseline|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400239|NCT00619801|P2|Participant Flow|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400240|NCT00619801|P1|Participant Flow|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400241|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400242|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400243|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400244|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400245|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400246|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400247|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400248|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400249|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400250|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400251|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400252|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400253|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400254|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400255|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400256|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400257|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400258|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400259|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400260|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400638|NCT00619060|E1|Reported Event|Both Forearms|Forearms receiving the Myristyl and Placebo, both arms affected
400261|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400262|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400263|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400264|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400265|NCT00619801|O2|Outcome|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400266|NCT00619801|O1|Outcome|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400267|NCT00619801|E2|Reported Event|Levocetirizine|Levocetirizine dihydrochloride 1.25 mg (5 drops containing 5 mg/mL) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400268|NCT00619801|E1|Reported Event|Placebo|Placebo (5 drops) dosed by mouth at breakfast time and in the evening (the evening dose should be administered approximately 12 hours later), twice a day for 2 weeks from Visit 2 (Day 0) to Visit 4 (Day 14) or the Early Discontinuation Visit (EDV).
400269|NCT00619762|B1|Baseline|LTN - Porcine Acellulare Dermal Matrix in Breast Recon|This was a single arm sudy without a control arm LTM used to reinforce weak tissue in breast reconstruction surgery
400270|NCT00619762|P1|Participant Flow|LTM - Porcine Acellular Dermal Matrix in Breast Reconstruct|"This was a single arm sudy without a control arm~Use of LTM to reinforce weak tissue in two-stage (expander then permanent implant) immediate post-mastectomy breast reconstruction."
400271|NCT00619762|O1|Outcome|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
400272|NCT00619762|O1|Outcome|Treatment Arm|all available patients/breasts who completed specified visit
400273|NCT00619762|E1|Reported Event|Treatment Arm|All implanted patients in the study, that is 29 breasts in 17 patients
400274|NCT00619619|B9|Baseline|Total|Total of all reporting groups
400275|NCT00619619|B8|Baseline|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400276|NCT00619619|B7|Baseline|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400277|NCT00619619|B6|Baseline|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400278|NCT00619619|B5|Baseline|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400279|NCT00619619|B4|Baseline|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400280|NCT00619619|B3|Baseline|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400281|NCT00619619|B2|Baseline|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400282|NCT00619619|B1|Baseline|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400283|NCT00619619|P8|Participant Flow|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400284|NCT00619619|P7|Participant Flow|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400285|NCT00619619|P6|Participant Flow|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400286|NCT00619619|P5|Participant Flow|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400287|NCT00619619|P4|Participant Flow|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400401|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400288|NCT00619619|P3|Participant Flow|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400289|NCT00619619|P2|Participant Flow|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400290|NCT00619619|P1|Participant Flow|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400291|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400292|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400293|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400294|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400295|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400296|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400297|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400298|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400299|NCT00619619|O1|Outcome|Desvenlafaxine - Combined Children and Adolescent Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels and Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
400300|NCT00619619|O2|Outcome|Desvenlafaxine – Combined Adolescent Cohorts|Desvenlafaxine sustained release tablets for 25 mg, 50 mg, 100 mg, and 200 mg Adolescent cohort dose levels.
400301|NCT00619619|O1|Outcome|Desvenlafaxine – Combined Children Cohorts|Desvenlafaxine sustained release tablets for 10 mg, 25 mg, 50 mg, and 100 mg Children cohort dose levels.
400302|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400303|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400304|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400305|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400306|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400307|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400308|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400309|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400310|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400311|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400312|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400313|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400314|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400402|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400315|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400316|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400317|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400318|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400319|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400320|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400321|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400322|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400323|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400324|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400325|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400326|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400327|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400328|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400329|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400330|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400331|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400332|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400333|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400334|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400335|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400336|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400337|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400338|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400339|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400340|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400341|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400342|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400343|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400344|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400345|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400346|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400347|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400348|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400349|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400350|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400351|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400352|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400353|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400354|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400355|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400356|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400357|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400358|NCT00619619|O8|Outcome|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400359|NCT00619619|O7|Outcome|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400360|NCT00619619|O6|Outcome|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400361|NCT00619619|O5|Outcome|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400362|NCT00619619|O4|Outcome|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400363|NCT00619619|O3|Outcome|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400364|NCT00619619|O2|Outcome|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400365|NCT00619619|O1|Outcome|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400366|NCT00619619|E8|Reported Event|Desvenlafaxine 200 mg Adolescent|Desvenlafaxine sustained release two 100 mg tablets on Day 1, 50 mg tablet on Days 4 through 7, 100 mg tablet on Days 8 through 14, two 100 mg tablets on days 15 through 56, 100 mg tablet on taper Days 1 through 7, 50 mg tablet for taper Days 8 through 14.
400367|NCT00619619|E7|Reported Event|Desvenlafaxine 100 mg Adolescent|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400368|NCT00619619|E6|Reported Event|Desvenlafaxine 50 mg Adolescent|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400369|NCT00619619|E5|Reported Event|Desvenlafaxine 25 mg Adolescent|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
401507|NCT00617201|B3|Baseline|Total|Total of all reporting groups
400370|NCT00619619|E4|Reported Event|Desvenlafaxine 100 mg Children|Desvenlafaxine sustained release 100 mg tablet on Day 1, 25 mg tablet on Days 4 through 7, 50 mg tablet on Days 8 through 14, 100 mg tablet on days 15 through 56, 50 mg tablet on taper Days 1 through 7, 25 mg tablet for taper Days 8 through 14.
400371|NCT00619619|E3|Reported Event|Desvenlafaxine 50 mg Children|Desvenlafaxine sustained release 50 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 14, 50 mg tablet on days 15 through 56, 25 mg tablet on taper Days 1 through 7, 10 mg tablet for taper Days 8 through 14.
400372|NCT00619619|E2|Reported Event|Desvenlafaxine 25 mg Children|Desvenlafaxine sustained release 25 mg tablet on Day 1, 10 mg tablet on Days 4 through 7, 25 mg tablet on Days 8 through 56, 10 mg tablet for 7 day taper.
400373|NCT00619619|E1|Reported Event|Desvenlafaxine 10 mg Children|Desvenlafaxine sustained release 10 milligram (mg) tablet
400374|NCT00619502|B3|Baseline|Total|Total of all reporting groups
400375|NCT00619502|B2|Baseline|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
400376|NCT00619502|B1|Baseline|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
400377|NCT00619502|P2|Participant Flow|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
400378|NCT00619502|P1|Participant Flow|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
400379|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
400380|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP-T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP-T at 15 to 18 months of age in the present study.
400381|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
400382|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
400383|NCT00619502|O2|Outcome|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
400384|NCT00619502|O1|Outcome|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
400385|NCT00619502|E2|Reported Event|Pentaxim™ + Engerix B™|All participants received a primary series of 3 vaccinations with Pentaxim™ and Engerix B™ vaccines, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-Hep B-PRP~T at 15 to 18 months of age in the present study.
400386|NCT00619502|E1|Reported Event|DTaP-IPV-HepB-PRP~T|All participants received a primary series of 3 vaccinations with DTaP-IPV-HepB-PRP~T, with 1 dose each at 2, 3, and 4 months of age, in Study A3L10; they received a booster dose of DTaP-IPV-HepB-PRP~T at 15 to 18 months of age in the present study.
400387|NCT00619489|B3|Baseline|Total|Total of all reporting groups
400388|NCT00619489|B2|Baseline|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400389|NCT00619489|B1|Baseline|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400390|NCT00619489|P2|Participant Flow|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400391|NCT00619489|P1|Participant Flow|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400392|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400393|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400394|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400395|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400396|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400397|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400398|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400399|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400634|NCT00619060|O1|Outcome|Myristyl Nicotinate Cream|Participants apply topical myristyl nicotinate to one forearm.
400403|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400404|NCT00619489|O2|Outcome|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400405|NCT00619489|O1|Outcome|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400406|NCT00619489|E2|Reported Event|Vedolizumab 6 mg/kg|Participants received vedolizumab, 6 mg/kg, IV, on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400407|NCT00619489|E1|Reported Event|Vedolizumab 2 mg/kg|Participants received vedolizumab, 2 mg/kg, intravenously (IV), on Days 1, 15 and 43, and thereafter once every 8 weeks for up to 78 weeks
400408|NCT00619476|B5|Baseline|Total|Total of all reporting groups
400409|NCT00619476|B4|Baseline|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400410|NCT00619476|B3|Baseline|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400411|NCT00619476|B2|Baseline|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400412|NCT00619476|B1|Baseline|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400413|NCT00619476|P4|Participant Flow|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400414|NCT00619476|P3|Participant Flow|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400415|NCT00619476|P2|Participant Flow|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400416|NCT00619476|P1|Participant Flow|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400417|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400418|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400419|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400420|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400421|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400422|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400423|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400424|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400425|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400426|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400427|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400428|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400429|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400430|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400431|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400432|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400433|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400434|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400435|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400436|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400437|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400438|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400439|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400440|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400441|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400442|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400443|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400444|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400445|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400446|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400639|NCT00618995|B1|Baseline|Totals For Study|All participants in the study.
400447|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400448|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400449|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400450|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400451|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400452|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400453|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400454|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400455|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400456|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400457|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400458|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400459|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400460|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400461|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400462|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400463|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400464|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400465|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400466|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400467|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400468|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400469|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400470|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400471|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400472|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400473|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400474|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400475|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400476|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400477|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400478|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400479|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400480|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400481|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400482|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400483|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400484|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400485|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400486|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400487|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400488|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400489|NCT00619476|O4|Outcome|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400490|NCT00619476|O3|Outcome|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400491|NCT00619476|O2|Outcome|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400492|NCT00619476|O1|Outcome|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400493|NCT00619476|E4|Reported Event|GEn 3600 mg/Day|Three 600 mg GEn tablets taken orally twice daily (morning and evening)
400494|NCT00619476|E3|Reported Event|GEn 2400 mg/Day|Two 600 mg GEn tablets and one GEN placebo tablet taken orally twice daily (morning and evening)
400495|NCT00619476|E2|Reported Event|GEn 1200 mg/Day|One 600 mg GEn tablet and two GEn placebo tablets taken orally twice daily (morning and evening)
400496|NCT00619476|E1|Reported Event|Placebo|Three 600 milligram (mg) gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, placebo tablets taken orally twice daily (morning and evening)
400497|NCT00619385|B4|Baseline|Total|Total of all reporting groups
400498|NCT00619385|B3|Baseline|Proellex 200 mg|"Proellex 200 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
400499|NCT00619385|B2|Baseline|Proellex 150 mg|"Proellex 150 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
400500|NCT00619385|B1|Baseline|Proellex 100 mg|"Proellex 100 mg daily for 7 days~Proellex: Proellex 25 mg capsules 100 mg, 150 mg or 200mg daily for 7 days"
400501|NCT00619385|P3|Participant Flow|Proellex 200 mg|Proellex 200 mg daily for 7 days
400502|NCT00619385|P2|Participant Flow|Proellex 150 mg|Proellex 150 mg daily for 7 days
400503|NCT00619385|P1|Participant Flow|Proellex 100 mg|Proellex 100 mg daily for 7 days
400504|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg vials daily for 7 days
400505|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg capsules daily for 7 days
400506|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
400507|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
400508|NCT00619385|O4|Outcome|Proellex 200 mg Vials|Proellex 200 mg daily for 7 days vials
400509|NCT00619385|O3|Outcome|Proellex 200 mg Caps|Proellex 200 mg daily for 7 days capsules
400510|NCT00619385|O2|Outcome|Proellex 150 mg|Proellex 150 mg daily for 7 days
400511|NCT00619385|O1|Outcome|Proellex 100 mg|Proellex 100 mg daily for 7 days
400512|NCT00619385|E3|Reported Event|Proellex 200 mg|Proellex 200 mg daily for 7 days
400513|NCT00619385|E2|Reported Event|Proellex 150 mg|Proellex 150 mg daily for 7 days
400514|NCT00619385|E1|Reported Event|Proellex 100 mg|Proellex 100 mg daily for 7 days
400515|NCT00619359|B3|Baseline|Total|Total of all reporting groups
400516|NCT00619359|B2|Baseline|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
400517|NCT00619359|B1|Baseline|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
400518|NCT00619359|P2|Participant Flow|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
400519|NCT00619359|P1|Participant Flow|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
400520|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
400521|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
400522|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
400523|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
400524|NCT00619359|O2|Outcome|Aprepitant|Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.
400525|NCT00619359|O1|Outcome|Fosaprepitant|Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.
400526|NCT00619359|E2|Reported Event|Aprepitant|"Aprepitant 125 mg by mouth (PO), ondansetron 32 mg IV, and dexamethasone 12 mg PO on Day 1, aprepitant 80 mg PO and dexamethasone 8 mg PO on Days 2 and 3, dexamethasone 8 mg PO on Day 4.~6 patients from the aprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
400527|NCT00619359|E1|Reported Event|Fosaprepitant|"Fosaprepitant dimeglumine 150 mg IV, ondansetron 32 mg IV, and dexamethasone 12 mg by mouth (PO) on Day 1, dexamethasone 8 mg PO on Day 2, and dexamethasone 16 mg PO on Days 3 and 4.~4 patients from the fosaprepitant regimen were randomized to the study, but discontinued before receiving study drug. These patients were excluded from the Adverse Event tables."
400528|NCT00619307|B3|Baseline|Total|Total of all reporting groups
400529|NCT00619307|B2|Baseline|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400530|NCT00619307|B1|Baseline|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400531|NCT00619307|P2|Participant Flow|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400532|NCT00619307|P1|Participant Flow|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400533|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400534|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400535|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400536|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400537|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400538|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400539|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400540|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400541|NCT00619307|O2|Outcome|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400542|NCT00619307|O1|Outcome|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400543|NCT00619307|E2|Reported Event|Transition With PRN Ibuprofen|subjects were instructed not to administer ibuprofen before the first RNF injection. Ibuprofen was taken solely as needed, PRN, after RNF injections to alleviate the symptoms of FLS. If FLS occurred after a RNF injection, then the subject could administer the first dose of ibuprofen 400 mg. The second dose of ibuprofen 400 mg could be taken 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours of RNF injection.
400635|NCT00619060|E4|Reported Event|Other Non-Derm Events|Systemic Other Adverse Events, i.e. Common Cold, Migraine
400544|NCT00619307|E1|Reported Event|Transition With Prophylactic Ibuprofen|"subjects received ibuprofen as prophylactic treatment against FLS on days when RNF 44 mcg tiw was injected (3 times weekly). Mandatory 400 mg of ibuprofen was administered prophylactically 30 to 60 minutes before each RNF injection.~Optionally the subject could take another 400 mg 6 hours after the first ibuprofen dose or upon waking if more than 6 hours later and if necessary a third dose of 400 mg 6 hours later, adding up to a maximum of 1200 mg within 24 hours."
400545|NCT00619242|B1|Baseline|Sorafenib|
400546|NCT00619242|P1|Participant Flow|Sorafenib|Sorafenib 400mg BID
400547|NCT00619242|O1|Outcome|Sorafenib|
400548|NCT00619242|E1|Reported Event|Sorafenib|
400549|NCT00619229|B3|Baseline|Total|Total of all reporting groups
400550|NCT00619229|B2|Baseline|Placebo|Placebo i.v. for 15 days
400551|NCT00619229|B1|Baseline|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400552|NCT00619229|P2|Participant Flow|Placebo|Placebo i.v. for 15 days
400553|NCT00619229|P1|Participant Flow|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400554|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400555|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400556|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400557|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400558|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400559|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400560|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400561|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400562|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400563|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400564|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400565|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400566|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400567|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400568|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400569|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400570|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400571|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400572|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400573|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400574|NCT00619229|O2|Outcome|Placebo|Placebo i.v. for 15 days
400575|NCT00619229|O1|Outcome|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400576|NCT00619229|E2|Reported Event|Placebo|Placebo i.v. for 15 days
400577|NCT00619229|E1|Reported Event|Alprostadil|Alprostadil 60 mcg/day i.v. for 15 days
400578|NCT00619190|B3|Baseline|Total|Total of all reporting groups
400579|NCT00619190|B2|Baseline|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
400580|NCT00619190|B1|Baseline|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400581|NCT00619190|P2|Participant Flow|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial.
400582|NCT00619190|P1|Participant Flow|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400583|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
400584|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400585|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
400586|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400587|NCT00619190|O2|Outcome|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
400588|NCT00619190|O1|Outcome|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400589|NCT00619190|E2|Reported Event|no Medication Control|group of children whose parents do not want them to take medications for autism over the year following enrollment in the trial. They may receive behavioral interventions
400590|NCT00619190|E1|Reported Event|Open Aripipraprazole|Openly provided, flexibly dosed aripiprazole in doses from 1mg to 30mg
400591|NCT00619177|B1|Baseline|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400592|NCT00619177|P1|Participant Flow|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400593|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400594|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400595|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400596|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400597|NCT00619177|O1|Outcome|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 – 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400636|NCT00619060|E3|Reported Event|Myristyl Forearm (Only)|Forearms receiving the Myristyl
400598|NCT00619177|E1|Reported Event|Meloxicam 7.5 mg Tablets, 15 mg Tablets or Injection|7.5 - 15 mg once daily (intramuscular injection and/or tablet), depending on clinical need and judgement of physician
400599|NCT00619151|B3|Baseline|Total|Total of all reporting groups
400600|NCT00619151|B2|Baseline|St.Jude Valve|St. Jude Medical Regent Valve
400601|NCT00619151|B1|Baseline|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
400602|NCT00619151|P2|Participant Flow|St.Jude Valve|St. Jude Medical Regent Valve
400603|NCT00619151|P1|Participant Flow|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
400604|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
400605|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
400606|NCT00619151|O2|Outcome|St.Jude Valve|St. Jude Medical Regent Valve
400607|NCT00619151|O1|Outcome|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
400608|NCT00619151|E2|Reported Event|St.Jude Valve|St. Jude Medical Regent Valve
400609|NCT00619151|E1|Reported Event|Top Hat Valve|CarboMedics Supra-annular Top Hat Valve
400610|NCT00619112|B1|Baseline|Temozolomide|"single arm trial~temozolomide : single arm study"
400611|NCT00619112|P1|Participant Flow|Temozolomide|"single arm trial~temozolomide : single arm study"
400612|NCT00619112|O1|Outcome|Temozolomide|"single arm trial~temozolomide : single arm study"
400613|NCT00619112|E1|Reported Event|Temozolomide|"single arm trial~temozolomide : single arm study"
400614|NCT00619099|B3|Baseline|Total|Total of all reporting groups
400615|NCT00619099|B2|Baseline|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400616|NCT00619099|B1|Baseline|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400617|NCT00619099|P2|Participant Flow|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400618|NCT00619099|P1|Participant Flow|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400619|NCT00619099|O2|Outcome|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400620|NCT00619099|O1|Outcome|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400621|NCT00619099|E2|Reported Event|Schedule B: SQ Once Every 7 Days|Decitabine : Schedule B: decitabine will be administered SQ every 7 days for 21 days (Days 1, 8, and 15) followed by 7 days without an administration of decitabine. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400622|NCT00619099|E1|Reported Event|Schedule A: SQ 3 Consecutive Days|Decitabine : Schedule A: decitabine will be administered subcutaneously (SQ) daily for 3 consecutive days (Days 1 to 3) every 28 days. The dose will be 20 mg/m^2/day. One course will be considered 28 days.
400623|NCT00619073|B1|Baseline|Entire Study Population|Includes groups randomized to receive clopidogrel + aspirin first and placebo + aspirin first
400624|NCT00619073|P2|Participant Flow|Placebo Then Clopidogrel|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. clopidogrel) will then be discontinued and aspirin continued for another 45 days.
400625|NCT00619073|P1|Participant Flow|Clopidogrel Then Placebo|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 45 days. After a 30 day washout from completion of first intervention, the subjects will be crossed over to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e. placebo) will then be discontinued and aspirin continued for another 45 days.
400626|NCT00619073|O2|Outcome|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
400627|NCT00619073|O1|Outcome|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
400628|NCT00619073|E2|Reported Event|Placebo + Aspirin|The subjects will be randomized to placebo plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., placebo) will then be discontinued and aspirin continued for another 43 days.
400629|NCT00619073|E1|Reported Event|Clopidogrel + Aspirin|The subjects will be randomized to clopidogrel 75 mg plus aspirin 81 mg orally daily for 14 days. The study drug (i.e., clopidogrel) will then be discontinued and aspirin continued for another 43 days.
400630|NCT00619060|B1|Baseline|Myristyl, Placebo|"Participants apply topical myristyl nicotinate to the and topical placebo to the other forearm once daily for 4 weeks; Myristyl, Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
400631|NCT00619060|P2|Participant Flow|Myristyl (Left), Placebo (Right)|Participants apply topical myristyl nicotinate to the left forearm and topical placebo to the right forearm once daily for 4 weeks; Myristyl (Left), Placebo (Right)Topical Myristyl Nicotinate Cream and Placebo
400632|NCT00619060|P1|Participant Flow|Myristyl (Right), Placebo (Left)|"Participants apply topical myristyl nicotinate to the right forearm and topical placebo to the left forearm once daily for 4 weeks; Myristyl (Right), Placebo (Left)Topical Myristyl Nicotinate Cream and Placebo~Topical Myristyl Nicotinate Cream and Placebo : Applied topically"
400633|NCT00619060|O2|Outcome|Topical Placebo Cream|Participants apply topical placebo cream to one forearm.
400640|NCT00618995|P4|Participant Flow|Sequence 4: A/D/B/C|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
400641|NCT00618995|P3|Participant Flow|Sequence 3: B/A/C/D|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
400642|NCT00618995|P2|Participant Flow|Sequence 2: C/B/D/A|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
400643|NCT00618995|P1|Participant Flow|Sequence 1: D/C/A/B|"A = ER Niacin 2 g/Laropiprant 40 mg once daily for 7 days~B = ER Niacin 2 g once daily for 7 days~C = Laropiprant 40 mg once daily for 7 days~D = Placebo once daily for 7 days"
400644|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
400645|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
400646|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
400647|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
400648|NCT00618995|O4|Outcome|Placebo|Placebo once daily for 7 days
400649|NCT00618995|O3|Outcome|Laropiprant|Laropiprant 40 mg once daily for 7 days
400650|NCT00618995|O2|Outcome|ER Niacin|ER Niacin 2 g once daily for 7 days
400651|NCT00618995|O1|Outcome|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
400652|NCT00618995|E4|Reported Event|Placebo|Placebo once daily for 7 days
400653|NCT00618995|E3|Reported Event|Laropiprant|Laropiprant 40 mg once daily for 7 days
400654|NCT00618995|E2|Reported Event|ER Niacin|ER Niacin 2 g once daily for 7 days
400655|NCT00618995|E1|Reported Event|ER Niacin/Laropiprant|Extended Release (ER) Niacin 2 g/Laropiprant 40 mg once daily for 7 days
400656|NCT00618982|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400657|NCT00618982|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400658|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400659|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400660|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400661|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400662|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
400663|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
400664|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
400665|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
400666|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
400667|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
400668|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
400669|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
400670|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
400671|NCT00618982|O3|Outcome|Sorafenib (Nexavar, BAY43-9006)_800 mg|Participants received 800 mg orally twice daily (bid)
400672|NCT00618982|O2|Outcome|Sorafenib (Nexavar, BAY43-9006)_600 mg|Participants received 600 mg orally twice daily (bid)
400673|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)_400 mg|Participants received 400 mg orally twice daily (bid)
400674|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400675|NCT00618982|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle, 600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400676|NCT00618982|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Intrapatient dose escalation of sorafenib from 400 mg orally twice daily (bid) for the first cycle,600 mg bid for the second cycle and 800 mg bid until disease progression, unacceptable toxicity or withdrawal of consent. Dose reductions due to toxicities were allowed.
400677|NCT00618956|B3|Baseline|Total|Total of all reporting groups
400678|NCT00618956|B2|Baseline|Milnacipran|
400679|NCT00618956|B1|Baseline|Placebo|
400680|NCT00618956|P2|Participant Flow|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
400681|NCT00618956|P1|Participant Flow|Placebo|ITT N= 93, OC analyzed n=89
400682|NCT00618956|O2|Outcome|Milnacipran|ITT N=181, OC analyzed n=162
400688|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N= 93, OC analyzed n=82; hypertensive: ITT N=88, OC analyzed n=80
400689|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N= 42, OC analyzed n=37; hypertensive: ITT N=51, OC analyzed n=47
400690|NCT00618956|O2|Outcome|Milnacipran|ITT N= 181, OC analyzed n=176
400691|NCT00618956|O1|Outcome|Placebo|ITT N= 93, OC analyzed n=89
400692|NCT00618956|O2|Outcome|Milnacipran|Normotensive: ITT N=93, OC analyzed n=92; hypertensive: ITT N=88, OC analyzed n=84
400693|NCT00618956|O1|Outcome|Placebo|Normotensive: ITT N=42, OC analyzed n=39; hypertensive: ITT N=51, OC analyzed n=50
400694|NCT00618956|E2|Reported Event|Milnacipran|Milnacipran 100 to 200 mg/day tablet, oral administration, BID.
400695|NCT00618956|E1|Reported Event|Placebo|ITT N= 93, OC analyzed n=89
400696|NCT00618839|B1|Baseline|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
400697|NCT00618839|P1|Participant Flow|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
400698|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
400699|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
400700|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by subsequent autografting once the wound bed has become healthy enough to accept an autograft. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
400701|NCT00618839|O1|Outcome|StrataGraft|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
400702|NCT00618839|O2|Outcome|Cadaver Skin|The current standard of care for the management of severe burns or other major skin trauma is temporary coverage of the wound with cadaver skin followed by autografting once once sufficient donor skin is available for autografting. Excised wounds are covered temporarily with cadaver skin to reduce fluid loss and infection. In addition to preventing excessive dehydration, restoration of a permeability barrier maintains a moist wound environment which promotes wound healing. However, there is inconsistent availability of freshly-harvested cadaver grafts. In addition, the quality of cadaver skin is variable- cadaver skin is often contaminated and if cadaver skin had undergone prolonged storage or freezing this reduces the viability of cadaver skin.
400703|NCT00618839|O1|Outcome|StrataGraft Skin Tissue|StrataGraft skin tissue is a fully-differentiated tissue which exhibits barrier function comparable to that of intact human skin. StrataGraft consists of an epidermal layer of fully-stratified human keratinocytes growing on a dermal layer which is comprised of human fibroblasts embedded in a collagen matrix. StrataGraft skin tissue is a tough, suturable, meshable tissue product that is manufactured with a surface area of 44 cm2. StrataGraft tissue is not intended to be a patient-specific product but rather to provide an allogeneic skin substitute which reproduces many of the structural and biological properties of normal human skin and is anticipated to serve as a biological wound dressing.
400704|NCT00618839|E1|Reported Event|StrataGraft : Cadaver Allograft|Wounds were excised and the half-wound sites were randomized to receive StrataGraft skin tissue or cadaver allograft for 7 days until the wounds were ready for autografting.
400705|NCT00618813|B1|Baseline|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400706|NCT00618813|P1|Participant Flow|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400707|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400960|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400708|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400709|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400710|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400711|NCT00618813|O1|Outcome|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400712|NCT00618813|E1|Reported Event|Treatment (Combination Chemotherapy)|"See Detailed Description~radiation therapy: Undergo radiation therapy~therapeutic conventional surgery: Undergo surgery~etoposide: Given IV~ifosfamide: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~topotecan hydrochloride: Given IV~filgrastim: Given SC"
400713|NCT00618787|B3|Baseline|Total|Total of all reporting groups
400714|NCT00618787|B2|Baseline|COPA|Regular foam dressing without Polyhexamethylene Biguanide
400715|NCT00618787|B1|Baseline|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
400716|NCT00618787|P2|Participant Flow|COPA|Regular foam dressing without Polyhexamethylene Biguanide
400717|NCT00618787|P1|Participant Flow|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
400718|NCT00618787|O2|Outcome|COPA|Regular foam dressing without Polyhexamethylene Biguanide
400719|NCT00618787|O1|Outcome|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
400720|NCT00618787|E2|Reported Event|COPA|Regular foam dressing without Polyhexamethylene Biguanide
400721|NCT00618787|E1|Reported Event|COPA AMD|Foam dressing impregnated with Polyhexamethylene Biguanide
400722|NCT00618774|B3|Baseline|Total|Total of all reporting groups
400723|NCT00618774|B2|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400724|NCT00618774|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400725|NCT00618774|P2|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400726|NCT00618774|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400727|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400728|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400729|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400730|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400731|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400732|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400733|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400734|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400735|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400736|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400737|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400738|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400739|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400740|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400741|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400742|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400743|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400744|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400745|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400746|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400747|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400748|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400749|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400750|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400751|NCT00618774|O2|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400752|NCT00618774|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400753|NCT00618774|E2|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400754|NCT00618774|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|
400755|NCT00618748|B4|Baseline|Total|Total of all reporting groups
400756|NCT00618748|B3|Baseline|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400757|NCT00618748|B2|Baseline|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400758|NCT00618748|B1|Baseline|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400759|NCT00618748|P3|Participant Flow|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400760|NCT00618748|P2|Participant Flow|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400761|NCT00618748|P1|Participant Flow|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400762|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400763|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400764|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400765|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400766|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400767|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400768|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400769|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400770|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400771|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400772|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400773|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400774|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400775|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400776|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400777|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400778|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400779|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400780|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400781|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400782|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400783|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400784|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400785|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400786|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400787|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400788|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400789|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400790|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400791|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400792|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400793|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400794|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400795|NCT00618748|O3|Outcome|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400796|NCT00618748|O2|Outcome|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400797|NCT00618748|O1|Outcome|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400798|NCT00618748|E3|Reported Event|New Olanzapine|Participants who did not participate in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 48 weeks.
400799|NCT00618748|E2|Reported Event|Pre-Placebo|Participants who received placebo in acute phase of Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400961|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400800|NCT00618748|E1|Reported Event|Pre-Olanzapine|Participants who received olanzapine in Study HGMP (NCT#00510146), received olanzapine 5-20 mg/day, orally for 24 weeks.
400801|NCT00618722|B5|Baseline|Total|Total of all reporting groups
400802|NCT00618722|B4|Baseline|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400803|NCT00618722|B3|Baseline|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400804|NCT00618722|B2|Baseline|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400805|NCT00618722|B1|Baseline|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400806|NCT00618722|P4|Participant Flow|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400807|NCT00618722|P3|Participant Flow|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400808|NCT00618722|P2|Participant Flow|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400809|NCT00618722|P1|Participant Flow|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400810|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400811|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400812|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400813|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400814|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400815|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400816|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400817|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400818|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400819|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400820|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400821|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400822|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400823|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400824|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400825|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400826|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400827|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400828|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
401508|NCT00617201|B2|Baseline|Atomoxetine|Atomoxetine (80 mg/day)
400829|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400830|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400831|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400832|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400833|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400834|NCT00618722|O4|Outcome|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400835|NCT00618722|O3|Outcome|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400836|NCT00618722|O2|Outcome|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400837|NCT00618722|O1|Outcome|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400838|NCT00618722|E4|Reported Event|Placebo|Participants received placebo administered in 0.2 mL injections, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400839|NCT00618722|E3|Reported Event|Deoxycholic Acid Injection 4 mg/cm²|Participants received 2.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (4 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400840|NCT00618722|E2|Reported Event|Deoxycholic Acid Injection 2 mg/cm²|Participants received 1.0% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (2 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400841|NCT00618722|E1|Reported Event|Deoxycholic Acid Injection 1 mg/cm²|Participants received 0.5% deoxycholic acid administered in 0.2 mL injections, up to 4.8 mL (1 mg/cm²) per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400842|NCT00618618|B5|Baseline|Total|Total of all reporting groups
400843|NCT00618618|B4|Baseline|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400844|NCT00618618|B3|Baseline|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400845|NCT00618618|B2|Baseline|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400846|NCT00618618|B1|Baseline|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400847|NCT00618618|P4|Participant Flow|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400848|NCT00618618|P3|Participant Flow|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400849|NCT00618618|P2|Participant Flow|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400850|NCT00618618|P1|Participant Flow|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400851|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400852|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400853|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400854|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400855|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400856|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400857|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400858|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400859|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400860|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400861|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400862|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400863|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400864|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400865|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400866|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400867|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400868|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400869|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400870|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400871|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400872|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400873|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400874|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400875|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400876|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400877|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400878|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400879|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400880|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400881|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400882|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400883|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400884|NCT00618618|O3|Outcome|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400885|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400886|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400887|NCT00618618|O4|Outcome|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400888|NCT00618618|O3|Outcome|0Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400889|NCT00618618|O2|Outcome|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400890|NCT00618618|O1|Outcome|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400891|NCT00618618|E4|Reported Event|Pooled Placebo|Participants received matching placebo administered in 0.2 or 0.4 mL injections, 0.7 or 1.0 cm apart, up to 4.8 or 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400892|NCT00618618|E3|Reported Event|Deoxycholic Acid Injection 0.4 mL/1.0 cm|Participants received deoxycholic acid administered in 0.4 mL injections, 1.0 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400893|NCT00618618|E2|Reported Event|Deoxycholic Acid Injection 0.2 mL/1.0 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 1.0 cm apart, up to 4.8 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400894|NCT00618618|E1|Reported Event|Deoxycholic Acid Injection 0.2 mL/0.7 cm|Participants received deoxycholic acid administered in 0.2 mL injections, 0.7 cm apart, up to 9.6 mL per treatment session at intervals of approximately 1 month for up to a maximum of 4 treatments.
400895|NCT00618540|B1|Baseline|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400896|NCT00618540|P1|Participant Flow|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400897|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400898|NCT00618540|O1|Outcome|Alemtuzumab|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400899|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400900|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400923|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400924|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400901|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400902|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400903|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400904|NCT00618540|O1|Outcome|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400905|NCT00618540|E1|Reported Event|Alemtuzumab Conditioning|"Patients administered with alemtuzumab, fludarabine phosphate, melphalan and donor stem cell transplantation in children with resistant Langerhans cell histiocytosis.~alemtuzumab: Administered intravenously (IV) 0.2 mg/kg on Days -8 through -4.~fludarabine phosphate: Administered 30 mg/m2 intravenously (IV) over 30-60 min on Days -7 through -3.~(dose adjust if age <12 months)~melphalan: Administered 140 mg/m2 intravenously (IV) over 30 min on Day -2 (dose adjust if age <12 months)~stem cell transplantation: Administered as allogeneic hematopoietic, peripheral blood or umbilical cord blood transplantation"
400906|NCT00618514|B3|Baseline|Total|Total of all reporting groups
400907|NCT00618514|B2|Baseline|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400908|NCT00618514|B1|Baseline|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400909|NCT00618514|P3|Participant Flow|Bright Tip Laser & Bare Tip Laser|Subjects that received testament of both limbs using the investigational device (Bright Tip laser) and the control (bare tip laser)
400910|NCT00618514|P2|Participant Flow|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this arm had only one limb treated with the bare tip laser fiber (control).
400911|NCT00618514|P1|Participant Flow|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts. Subjects in this category had only one limb treated with the Bright tip laser fiber.
400912|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400913|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400914|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400915|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400916|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400917|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400918|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400919|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400920|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400921|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400922|NCT00618514|O2|Outcome|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400925|NCT00618514|O1|Outcome|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400926|NCT00618514|E2|Reported Event|Standard Bare Tip Laser Fiber|Control Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400927|NCT00618514|E1|Reported Event|Bright Tip Laser Fiber|Investigational Device: The laser fiber is positioned at least two cm distal to the saphenofemoral junction. Laser energy is delivered through the 810 nm diode laser set at 10-14 watts.
400928|NCT00618449|B3|Baseline|Total|Total of all reporting groups
400929|NCT00618449|B2|Baseline|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400930|NCT00618449|B1|Baseline|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400931|NCT00618449|P2|Participant Flow|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400932|NCT00618449|P1|Participant Flow|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400933|NCT00618449|O2|Outcome|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400934|NCT00618449|O1|Outcome|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400935|NCT00618449|E2|Reported Event|Single-dose Azithromcyin|Subjects residing in villages assigned to treatment arm 1 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0); received the WHO standard of care for trachoma - 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400936|NCT00618449|E1|Reported Event|Two-doses of Azithromycin|Subjects residing in villages assigned to treatment arm 2 received a clinical evaluation for trachoma and provided a swab specimen of conjunctivae of the R eye at enrollment (Day 0) followed by an initial treatment with 1 gm oral dose of Azithromycin; received a second 1 gm oral dose of Azithromycin at Day 30; were re-screened (clinical evaluation and swab specimen of R eye collected) at Day 60; and again at Day 360.
400937|NCT00618436|B3|Baseline|Total|Total of all reporting groups
400938|NCT00618436|B2|Baseline|Phenytoin|This group will receive treatment with Phenytoin.
400939|NCT00618436|B1|Baseline|Levetiracetam|This group will receive treatment with Levetiracetam.
400940|NCT00618436|P2|Participant Flow|Phenytoin|This group will receive treatment with Phenytoin.
400941|NCT00618436|P1|Participant Flow|Levetiracetam|This group will receive treatment with Levetiracetam.
400942|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
400943|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
400944|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
400945|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
400946|NCT00618436|O2|Outcome|Phenytoin|This group will receive treatment with Phenytoin.
400947|NCT00618436|O1|Outcome|Levetiracetam|This group will receive treatment with Levetiracetam.
400948|NCT00618436|E2|Reported Event|Phenytoin|This group will receive treatment with Phenytoin.
400949|NCT00618436|E1|Reported Event|Levetiracetam|This group will receive treatment with Levetiracetam.
400950|NCT00618410|B1|Baseline|Entire Study Population|Study population includes subjects receiving interventions in either order.
400951|NCT00618410|P2|Participant Flow|Placebo, Then Carbon Dioxide|"Intervention sequence:~Intervention #1: nasal placebo administered 30 minutes prior to nasal challenge~Intervention #2: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge"
400952|NCT00618410|P1|Participant Flow|Carbon Dioxide, Then Placebo|"Intervention sequence:~Intervention #1: nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge~Intervention #2: nasal placebo administered 30 minutes prior to nasal challenge"
400953|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400954|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400955|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400956|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400957|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400958|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
401509|NCT00617201|B1|Baseline|Placebo|Matched placebo
400962|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400963|NCT00618410|O2|Outcome|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400964|NCT00618410|O1|Outcome|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400965|NCT00618410|E2|Reported Event|Placebo|nasal placebo administered 30 minutes prior to nasal challenge
400966|NCT00618410|E1|Reported Event|Carbon Dioxide|nasal Carbon dioxide, USP (CO2) administered 30 minutes prior to nasal challenge
400967|NCT00618371|B1|Baseline|Group 1|Group receiving raltegravir
400968|NCT00618371|P1|Participant Flow|Group 1|group to be treated with raltegravir
400969|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification. Samples from 0 participants were analyzed No Patients experienced ≥ 1 log decline in viral RNA, so no samples could be analyzed
400970|NCT00618371|O1|Outcome|Raltegravir Intensification|participants received 4 wk raltegravir intensification
400971|NCT00618371|E1|Reported Event|Group 1|group treated with raltegravir
400972|NCT00618332|B3|Baseline|Total|Total of all reporting groups
400973|NCT00618332|B2|Baseline|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400974|NCT00618332|B1|Baseline|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400975|NCT00618332|P2|Participant Flow|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400976|NCT00618332|P1|Participant Flow|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400977|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400978|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400979|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400980|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400981|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400982|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400983|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400984|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400985|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400986|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400987|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400988|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400989|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400990|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400991|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400992|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400993|NCT00618332|O2|Outcome|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400994|NCT00618332|O1|Outcome|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400995|NCT00618332|E2|Reported Event|Placebo|"2 weeks of treatment~placebo : 2 puffs in each nostril once a day for 2 weeks"
400996|NCT00618332|E1|Reported Event|Mometasone Furoate|"2 weeks of treatment~mometasone furoate nasal spray : 2 puffs in each nostril once a day for 2 weeks"
400997|NCT00618072|B4|Baseline|Total|Total of all reporting groups
400998|NCT00618072|B3|Baseline|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
400999|NCT00618072|B2|Baseline|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
401000|NCT00618072|B1|Baseline|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day
401001|NCT00618072|P3|Participant Flow|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401002|NCT00618072|P2|Participant Flow|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401003|NCT00618072|P1|Participant Flow|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
402378|NCT00615108|E1|Reported Event|Hypertension Patients|Telmisartan 40mg or 80 mg
401004|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401005|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401006|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401007|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401008|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401009|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401010|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401011|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401012|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401013|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401014|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401015|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401016|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401017|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401018|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401019|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401020|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401021|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401022|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401023|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401164|NCT00617851|O4|Outcome|Comparator Influenza Vaccine (Strain A/H1N1)|One injection of the comparator influenza virus vaccine-Strain A/H1N1
407039|NCT00603590|B2|Baseline|Control|Identical placebo tablet
401024|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401025|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401026|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401027|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401028|NCT00618072|O3|Outcome|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401029|NCT00618072|O2|Outcome|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401030|NCT00618072|O1|Outcome|A: EMPOWIR Diet and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a total dose of 4 mg/day.
401031|NCT00618072|E3|Reported Event|C: EMPOWIR Diet Plus Metformin and Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
401032|NCT00618072|E2|Reported Event|B: EMPOWIR Diet Plus Metformin and Placebo Avandia|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of rosiglitazone placebo 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
401033|NCT00618072|E1|Reported Event|A: EMPOWIR and Placebo|EMPOWIR dietary intervention food exchange program; 40-45% carbohydrates, 35-40% protein, and 20% fat AND 4 week dosage escalation of placebo metformin, 500 mg/day to a total dose of 2000mg/day; starting dose of placebo rosiglitazone 2mg/day added at weeks 3 and weeks 4 to a a total dose of 4 mg/day
401034|NCT00617929|B1|Baseline|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401035|NCT00617929|P1|Participant Flow|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401036|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401037|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401038|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401039|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401040|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401041|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401042|NCT00617929|O1|Outcome|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401043|NCT00617929|E1|Reported Event|Conditioning for Graft Failure After Transplant|Day -7: Rituximab 375 mg/m2 Day -6: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -5: Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -4: Clofarabine 30 mg/m2 IV over 1 hour and Antithymocyte globulin (Thymoglobulin) 3 mg/kg IV over 4 hours Day -3: Clofarabine 30 mg/m2 IV over 1 hour Day -2: Clofarabine 30 mg/m2 IV over 1 hour Day -1: Rest Day 0: Stem Cell Infusion
401044|NCT00617903|B3|Baseline|Total|Total of all reporting groups
401045|NCT00617903|B2|Baseline|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401046|NCT00617903|B1|Baseline|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401047|NCT00617903|P2|Participant Flow|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401048|NCT00617903|P1|Participant Flow|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401049|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401050|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401051|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401052|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401053|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401054|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401055|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401056|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401057|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401058|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401059|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401060|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401061|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401062|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401063|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401064|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401065|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401066|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401067|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401068|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401069|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401070|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401071|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401072|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401073|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401074|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401075|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401076|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401077|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401078|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401079|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401080|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401081|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401082|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401083|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401084|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401085|NCT00617903|O2|Outcome|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401086|NCT00617903|O1|Outcome|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401087|NCT00617903|E2|Reported Event|Vehicle Foam|Participants received vehicle foam topically twice daily for 12 weeks
401088|NCT00617903|E1|Reported Event|Azelaic Acid Foam, 15% (BAY39-6251)|Participants received azelaic acid foam, 15% topically twice daily for 12 weeks
401089|NCT00617890|B5|Baseline|Total|Total of all reporting groups
401090|NCT00617890|B4|Baseline|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401091|NCT00617890|B3|Baseline|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401092|NCT00617890|B2|Baseline|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401093|NCT00617890|B1|Baseline|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401094|NCT00617890|P4|Participant Flow|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401095|NCT00617890|P3|Participant Flow|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401096|NCT00617890|P2|Participant Flow|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401097|NCT00617890|P1|Participant Flow|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401098|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401099|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401100|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401101|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401102|NCT00617890|O2|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401103|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401104|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401105|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401106|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401107|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401108|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401109|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401110|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401111|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401112|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401113|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401114|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401115|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401116|NCT00617890|O4|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401117|NCT00617890|O3|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401118|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401119|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401120|NCT00617890|O1|Outcome|Group 2: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401121|NCT00617890|O2|Outcome|Group 1: 10 mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401122|NCT00617890|O1|Outcome|Group 1: 0.3 mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401165|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine-Strain B
401123|NCT00617890|O1|Outcome|Group 3: 10 mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401124|NCT00617890|E4|Reported Event|Group 3: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with Ewing's sarcoma refractory to prior treatment with at least 3 of the following agents: ifosfamide, etoposide, cyclophosphamide, doxorubicin, or vincristine.
401125|NCT00617890|E3|Reported Event|Group 2: 10mg/kg|Participants received robatumumab 10 mg/kg IV biweekly until disease recurrence or up to 1 year of dosing. This group comprised participants with relapsed and unresectable osteosarcoma refractory to prior chemotherapy with a platinum- and doxorubicin-containing regimen.
401126|NCT00617890|E2|Reported Event|Group 1: 10mg/kg|Participants received robatumumab 10 mg/kg IV as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 10 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401127|NCT00617890|E1|Reported Event|Group 1: 0.3mg/kg|Participants received robatumumab 0.3 mg/kg intravenously (IV) as a single dose on Day 1, followed by surgery on Day 10 to 14, and four weeks later, resumption of robatumumab 0.3 mg/kg on the same calendar day (± 3 days) once every 2 weeks until disease recurrence or up to 1 year of dosing. This group comprised participants with resectable osteosarcoma that relapsed within 6 months of prior definitive treatment (eg surgical metastasectomy) and having at least one prior chemotherapy regimen containing a platinum agent and doxorubicin.
401128|NCT00617851|B5|Baseline|Total|Total of all reporting groups
401129|NCT00617851|B4|Baseline|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401130|NCT00617851|B3|Baseline|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401131|NCT00617851|B2|Baseline|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401132|NCT00617851|B1|Baseline|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401133|NCT00617851|P4|Participant Flow|Comparator Influenza Vaccine|One injection of the comparator influeza virus vaccine
401134|NCT00617851|P3|Participant Flow|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influeza virus vaccine
401135|NCT00617851|P2|Participant Flow|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influeza virus vaccine
401136|NCT00617851|P1|Participant Flow|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influeza virus vaccine
401137|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401138|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401139|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401140|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401141|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401142|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401143|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401144|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401145|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401146|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401147|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401148|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401149|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401150|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401151|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401152|NCT00617851|O5|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401153|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401154|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401155|NCT00617851|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401156|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401157|NCT00617851|O5|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401158|NCT00617851|O4|Outcome|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401159|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401160|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401161|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401162|NCT00617851|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza virus vaccine-Strain B
401163|NCT00617851|O5|Outcome|Comparator Influenza Vaccine (Strain A/H3N2)|One injection of the comparator influenza virus vaccine-Strain A/H3N2
401166|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Strain A/H3N2)|One injection of the investigational influenza virus vaccine-Strain A/H3N2
401167|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Strain A/H1N1)|One injection of the investigational influenza virus vaccine-Strain A/H1N1
401168|NCT00617851|O3|Outcome|Influenza Virus Vaccine (Lot C)|One injection of lot C of the investigational influenza virus vaccine
401169|NCT00617851|O2|Outcome|Influenza Virus Vaccine (Lot B)|One injection of lot B of the investigational influenza virus vaccine
401170|NCT00617851|O1|Outcome|Influenza Virus Vaccine (Lot A)|One injection of lot A of the investigational influenza virus vaccine
401171|NCT00617851|E2|Reported Event|Comparator Influenza Vaccine|One injection of the comparator influenza virus vaccine
401172|NCT00617851|E1|Reported Event|Influenza Virus Vaccine (Pooled)|One injection of the investigational influenza virus vaccine (all lots pooled)
401173|NCT00617773|B1|Baseline|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401174|NCT00617773|P1|Participant Flow|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401175|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401176|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401177|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401178|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401179|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401180|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401181|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401182|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401183|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401184|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401185|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401186|NCT00617773|O1|Outcome|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401187|NCT00617773|E1|Reported Event|hu3S193|hu3S193 : 20 mg/m2, intravenous, weekly for a maximum of 3 cycles (of 8 weeks each)
401188|NCT00617708|B4|Baseline|Total|Total of all reporting groups
401189|NCT00617708|B3|Baseline|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401190|NCT00617708|B2|Baseline|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401191|NCT00617708|B1|Baseline|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401192|NCT00617708|P3|Participant Flow|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401193|NCT00617708|P2|Participant Flow|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401194|NCT00617708|P1|Participant Flow|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401195|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401196|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401197|NCT00617708|O3|Outcome|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401198|NCT00617708|O2|Outcome|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401199|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401200|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401201|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401202|NCT00617708|O1|Outcome|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401203|NCT00617708|O2|Outcome|Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401204|NCT00617708|O1|Outcome|Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401205|NCT00617708|E3|Reported Event|Ph II: Erlotinib + Gemcitabine|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15. One cycle = 28 days.
401206|NCT00617708|E2|Reported Event|Ph II: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401207|NCT00617708|E1|Reported Event|Ph I: Erlotinib + Gemcitabine + IMC-A12|Erlotinib 100 mg PO once daily, Gemcitabine 1,000 mg/m^2 IV days 1, 8 and 15, and IMC-A12 6 mg/kg IV days 1, 8, 15 and 22. One cycle = 28 days.
401208|NCT00617669|B3|Baseline|Total|Total of all reporting groups
401209|NCT00617669|B2|Baseline|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
402452|NCT00615017|B1|Baseline|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
401210|NCT00617669|B1|Baseline|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401211|NCT00617669|P2|Participant Flow|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401212|NCT00617669|P1|Participant Flow|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401213|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401214|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401215|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401216|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401217|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401218|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401219|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401220|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401221|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401222|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401223|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401224|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401225|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401226|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401227|NCT00617669|O2|Outcome|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401228|NCT00617669|O1|Outcome|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401229|NCT00617669|E2|Reported Event|Placebo + Docetaxel|placebo oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401230|NCT00617669|E1|Reported Event|ZD4054 + Docetaxel|XD4054 10 mg oral tablet once daily + docetaxel intravenous infusion every 3 weeks
401231|NCT00617604|B3|Baseline|Total|Total of all reporting groups
401232|NCT00617604|B2|Baseline|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401233|NCT00617604|B1|Baseline|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401234|NCT00617604|P2|Participant Flow|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401235|NCT00617604|P1|Participant Flow|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401236|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401237|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401238|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401239|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401240|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401241|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401242|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401243|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401244|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
402453|NCT00615017|P6|Participant Flow|Placebo|Placebo
401245|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401246|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401247|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401248|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401249|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401250|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401251|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401252|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401253|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401254|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401255|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401256|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401257|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401258|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401259|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401260|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401261|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401262|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401263|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401264|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401265|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401266|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401267|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401322|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401268|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401269|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401270|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401271|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401272|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401273|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401274|NCT00617604|O2|Outcome|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401275|NCT00617604|O1|Outcome|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401276|NCT00617604|E2|Reported Event|Alefacept|Participants received 7.5 mg alefacept administered intra-operatively as an IV bolus on Day 0, another 7.5 mg IV bolus on Day 3, and weekly subcutaneous injections of 15 mg alefacept thereafter for 12 weeks. Participants also received tacrolimus, MMF and steroid treatment.
401277|NCT00617604|E1|Reported Event|Placebo|Participants received placebo administered intra-operatively as an intravenous (IV) bolus on Day 0, another IV bolus on Day 3 and weekly subcutaneous injections thereafter for 12 weeks. Participants also received tacrolimus, mycophenolate mofetil (MMF) and steroid treatment.
401278|NCT00617591|B1|Baseline|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401279|NCT00617591|P1|Participant Flow|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401280|NCT00617591|O1|Outcome|Induction at Initial Full Dose|"Induction Phase for First 29 Participants~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1."
401281|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401282|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401283|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401323|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401324|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401284|NCT00617591|O1|Outcome|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and Pegylated Liposomal Doxorubicin (PLD) 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401285|NCT00617591|E1|Reported Event|Induction and Maintenance Therapy|"Induction Phase Followed by Maintenance Therapy.~Patients received lenalidomide 25 mg orally on days 1-21, dexamethasone 40 mg orally on days on 1-4, and PLD 40 mg/m^2 intravenously on day 1 (reduced to 30 mg/m^2 after the initial 29 patients were treated). Cycles were repeated every 28 days.~At the best response (4-8 cycles of induction), patients could proceed with either high-dose therapy or maintenance with lenalidomide and dexamethasone at the tolerated doses on the same schedule until disease progression.~Dd-R: Lenalidomide (Revlimid®) combined with Pegylated Liposomal Doxorubicin (Doxil®) and Dexamethasone (Decadron®) as outlined in the Detailed Description."
401286|NCT00617461|B1|Baseline|All Participants in the Intent-to-Treat Population|All randomized participants who took at least one dose of study drug and had at least one post-baseline efficacy assessment, summarized independent of treatment sequence.
401287|NCT00617461|P2|Participant Flow|GEn 3600 mg/Day Followed by GEn 1200 mg/Day|GEn 3600 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 1200 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days.
401288|NCT00617461|P1|Participant Flow|GEn 1200 mg/Day Followed by GEn 3600 mg/Day|Gabapentin enacarbil (XP13512/GSK1838262), hereafter referred to as GEn, 1200 mg/day administered for 28 days, followed by a 4-day crossover period during which participants received GEn 2400 mg/day. After the crossover period, participants switched to a dose of 3600 mg/day for 28 days. After completion of the second treatment period, participants entered a down-titration period in which they received 1200 mg/day for 3 days, followed by 600 mg/ day for 3 days.
401289|NCT00617461|O3|Outcome|Gabapentin 1800 mg|PK population from Gabapentin 1800 mg Baseline Treatment period
401290|NCT00617461|O2|Outcome|GEn 3600 mg|PK population from GEn 3600 mg treatment daily from either first intervention period or second intervention period
401291|NCT00617461|O1|Outcome|GEn 1200 mg|PK population from GEn 1200 mg treatment daily from either first intervention period or second intervention period
401292|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401293|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401294|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401295|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401296|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
401297|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
401298|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
401299|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
401300|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401301|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401302|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily either in second intervention period
401303|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
401304|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
401305|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
401306|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401307|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401308|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401309|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401310|NCT00617461|O4|Outcome|GEn 3600 mg in Second Intervention Period|GEn 3600 mg daily in second intervention period
401311|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period
401312|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period
401313|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period
401314|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401315|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401316|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401317|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401318|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401319|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401320|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401321|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401325|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401326|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401327|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401328|NCT00617461|O4|Outcome|GEn 3600 mg in Second Interevention Period|GEn 3600 mg daily in second intervention period only
401329|NCT00617461|O3|Outcome|GEn 1200 mg in Second Intervention Period|GEn 1200 mg daily in second intervention period only
401330|NCT00617461|O2|Outcome|GEn 3600 mg in First Intervention Period|GEn 3600 mg daily in first intervention period only
401331|NCT00617461|O1|Outcome|GEn 1200 mg in First Intervention Period|GEn 1200 mg daily in first intervention period only
401332|NCT00617461|O2|Outcome|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401333|NCT00617461|O1|Outcome|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401334|NCT00617461|E6|Reported Event|Overall GEn|All participants receiving GEn in any treatment period
401335|NCT00617461|E5|Reported Event|Down-Titration Period|Participants down- titrated from GEn 3600 mg/day by taking 2400 mg/day for 2 days, followed by 1200 mg/day for 2 days, followed by 600 mg/day for 2 days before ending the assigned treatment. Participants down- titrated from GEn 1200 mg/day by taking 1200 mg/day for 3 days, followed by 600 mg/day for 3 days before ending the assigned treatment.
401336|NCT00617461|E4|Reported Event|GEn 3600 mg|GEn 3600 mg daily either in first intervention period or second intervention period
401337|NCT00617461|E3|Reported Event|Crossover GEn 2400 mg|GEn 2400 mg daily during 4-day crossover period in between the first intervention period and the second intervention period
401338|NCT00617461|E2|Reported Event|GEn 1200 mg|GEn 1200 mg daily either in first intervention period or second intervention period
401339|NCT00617461|E1|Reported Event|Baseline Gabapentin 1800 mg|Gabapentin 1800 mg daily for 2 weeks before randomization. Only includes participants who were subsequently randomized.
401340|NCT00617409|B4|Baseline|Total|Total of all reporting groups
401341|NCT00617409|B3|Baseline|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
401342|NCT00617409|B2|Baseline|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
401343|NCT00617409|B1|Baseline|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
401344|NCT00617409|P3|Participant Flow|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
401345|NCT00617409|P2|Participant Flow|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
401346|NCT00617409|P1|Participant Flow|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
401347|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
401348|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
401349|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
401350|NCT00617409|O3|Outcome|Ad.p53-DC Vaccines + ATRA|Arm C - Experimental: Ad.p53-DC vaccines + All -trans Retinoic Acid (ATRA) + Second Line Chemo
401351|NCT00617409|O2|Outcome|Ad.p53-DC Vaccines|Arm B - Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
401352|NCT00617409|O1|Outcome|Standard of Care|Arm A - Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
401353|NCT00617409|E3|Reported Event|Arm C - Experimental|Experimental: Ad.p53-DC vaccines + ATRA + Second Line Chemo
401354|NCT00617409|E2|Reported Event|Arm B - Experimental|Experimental: Ad.p53-DC vaccines + Second Line Chemotherapy
401355|NCT00617409|E1|Reported Event|Arm A - Active Comparator|Active Comparator: Observation (Standard of Care) + Second Line Chemotherapy
401356|NCT00617396|B1|Baseline|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total) 25 subjects were enrolled in this group.
401357|NCT00617396|P1|Participant Flow|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subjects begin with a dose quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. 25 subjects were enrolled in this group.
401358|NCT00617396|O1|Outcome|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose quetiapine of 50mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)30 subjects were enrolled in this group.
401359|NCT00617396|E1|Reported Event|Quetiapine ( 50mg/Day -100mg/Day)|There is only one group. All Subject begin with a dose Quetiapine of 50 mg for 2 weeks, increasing to 100 mg for the remainder of the study. (9 weeks total)29 subjects were enrolled in this group.
401360|NCT00617357|B1|Baseline|One Arm|Strattice Reconstructive Tissue Matrix
401361|NCT00617357|P1|Participant Flow|Strattice Tissue Matrix|
401362|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401363|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401364|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401365|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401366|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401503|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401367|NCT00617357|O1|Outcome|Strattice Reconstructive Tissue Matrix|"Subjects implanted with Strattice Reconstructive Tissue Matrix in the repair of infected or contaminated hernias.~LTM (Strattice Reconstructive Tissue Matrix): Surgical mesh"
401368|NCT00617357|O1|Outcome|One Arm|Strattice Reconstructive Tissue Matrix
401369|NCT00617357|E1|Reported Event|Strattice|
401370|NCT00617305|B4|Baseline|Total|Total of all reporting groups
401371|NCT00617305|B3|Baseline|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
401372|NCT00617305|B2|Baseline|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
401373|NCT00617305|B1|Baseline|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
401374|NCT00617305|P3|Participant Flow|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
401375|NCT00617305|P2|Participant Flow|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i
401376|NCT00617305|P1|Participant Flow|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
401377|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401378|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401379|NCT00617305|O2|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401380|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401381|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401382|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401383|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401384|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401385|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401386|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401387|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401388|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401389|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401390|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401391|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401392|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401393|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401394|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401395|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401396|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401504|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401397|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401398|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401399|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401400|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401401|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401402|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401403|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401404|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401405|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401406|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401407|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401408|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401409|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401410|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401411|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401412|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401413|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401414|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401415|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401416|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401417|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401418|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401419|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401420|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401421|NCT00617305|O5|Outcome|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i (5 patients had baseline measurements in this group)
401422|NCT00617305|O4|Outcome|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i (37 patients had baseline measurements in this group)
401423|NCT00617305|O3|Outcome|Placebo Only|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i and did not receive ambrisentan (1 patient had baseline measurements in this group)
401505|NCT00617240|E2|Reported Event|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
410205|NCT00594464|O4|Outcome|Rotigotine 12 mg/24h|
401424|NCT00617305|O2|Outcome|Placebo/Ambrisentan|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i; patients also received at least one dose of open-label ambrisentan plus an approved PDE-5i (4 patients had baseline measurements in this group)
401425|NCT00617305|O1|Outcome|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i) (33 patients had baseline measurements in this group)
401426|NCT00617305|E3|Reported Event|Any Placebo|Patients were assigned placebo at randomization and received at least one dose of placebo plus an approved PDE-5i
401427|NCT00617305|E2|Reported Event|Any Ambrisentan|Patients were assigned either ambrisentan or placebo at enrollment or randomization and received at least one dose of ambrisentan plus an approved PDE-5i
401428|NCT00617305|E1|Reported Event|Ambrisentan Only|Patients were assigned ambrisentan at open-label enrollment or randomization, and received at least one dose of ambrisentan plus an approved phosphodiesterase type-5 (PDE-5) inhibitor (PDE-5i)
401429|NCT00617279|B3|Baseline|Total|Total of all reporting groups
401430|NCT00617279|B2|Baseline|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401431|NCT00617279|B1|Baseline|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401432|NCT00617279|P2|Participant Flow|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401433|NCT00617279|P1|Participant Flow|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401434|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401435|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401436|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401437|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401438|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401439|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401440|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401441|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401457|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401442|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401443|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401444|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401445|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401446|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401447|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401448|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401449|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401450|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401451|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401452|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401453|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401454|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401455|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401456|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401458|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401459|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401460|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401461|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401462|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401463|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401464|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401465|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401466|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401467|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401468|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401469|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401470|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401471|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401472|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401473|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401474|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401475|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401476|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401477|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401478|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401479|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401480|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401481|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401482|NCT00617279|O2|Outcome|Disadvantaged Autologous Vein Graft|Patients receiving Disadvantaged Autologous Vein Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease. 'Disadvantaged Autologous Vein Graft' was defined in the study as meeting one of two criteria: (1) Any autologous vein(s) other than greater saphenous vein deemed usable by the Investigator (and/or) (2) Usable ipsilateral or contralateral autologous greater saphenous vein that is either less than or equal to 3.0 mm in diameter, of inadequate length (requires vein splicing), or of poor quality vein (sclerotic or phlebitic).
401483|NCT00617279|O1|Outcome|GORE PROPATEN Vascular Graft:|Patients receiving the GORE PROPATEN Vascular Graft in a below-knee bypass due to severe claudication (pain, tension, and weakness in the legs), rest pain or tissue loss due to peripheral arterial occlusive disease.
401484|NCT00617279|E2|Reported Event|Disadvantaged Autologous Vein Graft|Disadvantaged Autologous Vein Graft
401485|NCT00617279|E1|Reported Event|GORE PROPATEN Vascular Graft|GORE PROPATEN Vascular Graft
401486|NCT00617240|B3|Baseline|Total|Total of all reporting groups
401487|NCT00617240|B2|Baseline|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401488|NCT00617240|B1|Baseline|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401489|NCT00617240|P2|Participant Flow|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401490|NCT00617240|P1|Participant Flow|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401491|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401492|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401493|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401494|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401495|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401496|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401497|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401498|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401499|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401500|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401501|NCT00617240|O2|Outcome|Placebo|Matched placebo to metformin, doses between 250/0mg and 2000/0,g per day
401502|NCT00617240|O1|Outcome|Metformin|metformin in doses from 250mg to 2000mg/day for 26 weeks
401510|NCT00617201|P2|Participant Flow|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
401511|NCT00617201|P1|Participant Flow|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
401512|NCT00617201|O2|Outcome|Atomoxetine|Atomoxetine (80 mg/day)
401513|NCT00617201|O1|Outcome|Placebo|Matched placebo
401514|NCT00617201|O2|Outcome|Atomoxetine|80 mg/day (after intial 4-day run up)
401515|NCT00617201|O1|Outcome|Placebo|Matched Placebo
401516|NCT00617201|E2|Reported Event|Matched Placebo|"Matched Placebo~placebo : Once daily oral dosing - matched placebo"
401517|NCT00617201|E1|Reported Event|Atomoxetine (80 mg/Day)|"Active drug~atomoxetine : Once daily oral dosing"
401518|NCT00617188|B1|Baseline|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401519|NCT00617188|P1|Participant Flow|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401520|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401521|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401522|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401523|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401524|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401525|NCT00617188|O1|Outcome|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401526|NCT00617188|E1|Reported Event|Fulvestrant Treatment|Patients who met Inclusion Criteria and received at least 1 dose of study drug (Fulvestrant 500 mg Day 1; 250 mg Day 1, 29 and every 28 days thereafter)
401527|NCT00617175|B3|Baseline|Total|Total of all reporting groups
401528|NCT00617175|B2|Baseline|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
401529|NCT00617175|B1|Baseline|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
401530|NCT00617175|P2|Participant Flow|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
401531|NCT00617175|P1|Participant Flow|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
401532|NCT00617175|O2|Outcome|NID 30/40|Prolonged number of interval to detect ventricular arrhythmias
401533|NCT00617175|O1|Outcome|NID 18/24|standard number of interval to detect ventricular arrhythmias
401534|NCT00617175|E2|Reported Event|Long NID|Programming a number of 30 out of 40 intervals to detect (NID)ventricular arrhythmia
401535|NCT00617175|E1|Reported Event|Short NID|Programming a number of 18 out of 24 intervals to detect (NID)ventricular arrhythmia
401536|NCT00617123|B3|Baseline|Total|Total of all reporting groups
401537|NCT00617123|B2|Baseline|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401538|NCT00617123|B1|Baseline|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401539|NCT00617123|P2|Participant Flow|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401540|NCT00617123|P1|Participant Flow|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401541|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401542|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401543|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401544|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401545|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401546|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401547|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401548|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401549|NCT00617123|O2|Outcome|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401550|NCT00617123|O1|Outcome|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401551|NCT00617123|E2|Reported Event|Placebo|Participants receive a matching placebo tablet to vorapaxar administered orally once daily for 1 year
401552|NCT00617123|E1|Reported Event|Vorapaxar|Participants receive a vorapaxar 2.5 mg tablet administered orally once daily for 1 year
401553|NCT00617097|B3|Baseline|Total|Total of all reporting groups
401554|NCT00617097|B2|Baseline|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control with paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
401555|NCT00617097|B1|Baseline|Paracervical Block With Lidocaine|Subjects who received pain control with paracervical block with 18mL of 1% lidocaine and 2mL of saline during first trimester surgical abortion
401556|NCT00617097|P2|Participant Flow|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control of paracervical block with combined 30mg of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
402972|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
401557|NCT00617097|P1|Participant Flow|Paracervical Block With Lidocaine|Subjects who received paracervical block with 18 mL of 1% lidocaine and 2 mL of saline for pain control during first trimester surgical abortion
401558|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
401559|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
401560|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
401561|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
401562|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
401563|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
401564|NCT00617097|O2|Outcome|Paracervical Block With Ketorolac and Lidocaine|Subjects who received pain control using paracervical block with 30mg (2mL) of ketorolac and 18mL of 1% lidocaine during first trimester surgical abortion
401565|NCT00617097|O1|Outcome|Paracervical Block With Lidocaine|Subjects who received pain control using paracervical block with 18mL of 1% lidocaine and 2 mL of saline during first trimester surgical abortion
401566|NCT00617097|E2|Reported Event|Paracervical Block With Ketorolac and Lidocaine|Subjects who receive pain control using paracervical block with ketorolac and lidocaine during first trimester surgical abortion
401567|NCT00617097|E1|Reported Event|Paracervical Block With Lidocaine|Subjects who receive pain control using paracervical block with lidocaine during first trimester surgical abortion
401568|NCT00617084|B3|Baseline|Total|Total of all reporting groups
401569|NCT00617084|B2|Baseline|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
401570|NCT00617084|B1|Baseline|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
401571|NCT00617084|P2|Participant Flow|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
401572|NCT00617084|P1|Participant Flow|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
401573|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
401574|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
401575|NCT00617084|O2|Outcome|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
401576|NCT00617084|O1|Outcome|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
401577|NCT00617084|E2|Reported Event|2. XIENCE V - 12-13 Months|Abbott Xience V - 12-13 Months
401578|NCT00617084|E1|Reported Event|1. Resolute - 12-13 Months|Medtronic Resolute - 12-13 Months
401579|NCT00617058|B4|Baseline|Total|Total of all reporting groups
401580|NCT00617058|B3|Baseline|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401581|NCT00617058|B2|Baseline|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401582|NCT00617058|B1|Baseline|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401583|NCT00617058|P3|Participant Flow|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401584|NCT00617058|P2|Participant Flow|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401585|NCT00617058|P1|Participant Flow|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401586|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401587|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401588|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401589|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401735|NCT00616772|P1|Participant Flow|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401590|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401591|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401592|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401593|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401594|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401595|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401596|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401597|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401598|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401599|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401600|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401601|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401602|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401603|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401604|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401605|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401606|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401607|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401608|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401609|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401631|NCT00616967|O1|Outcome|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
401610|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401611|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401612|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401613|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401614|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401615|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401616|NCT00617058|O3|Outcome|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401617|NCT00617058|O2|Outcome|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401618|NCT00617058|O1|Outcome|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401619|NCT00617058|E3|Reported Event|Elective Monitoring Control Group|For subjects who meet study criteria but are not interested in participating in a treatment study, this option for elective monitoring will be available. This group will be provided with psychiatric care, medication management, and weight monitoring and guidance for the duration of the study; however, subjects in this group will not receive any specific weight gain intervention.
401620|NCT00617058|E2|Reported Event|Healthy Lifestyle Instruction Group|"Healthy lifestyle intervention. Additional meeting at each psychiatric visit to review weight changes, level of physical activity and healthy eating behaviors~healthy lifestyle intervention : additional component to regular psychiatric visits that includes monitoring of lifestyle and eating behaviors."
401621|NCT00617058|E1|Reported Event|Co-Treatment With Metformin|"metformin, 250mg-2000 mg/day, in BID to TID doses for 26 weeks. Open, flexibly adjusted.~metformin : open dosed, randomly assigned flexible dose treatment with 250-2000mg/day divided BID or TID"
401622|NCT00616967|B3|Baseline|Total|Total of all reporting groups
401623|NCT00616967|B2|Baseline|Vorinostat (Arm 2)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
401624|NCT00616967|B1|Baseline|Placebo (Arm 1)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
401625|NCT00616967|P3|Participant Flow|Vorinostat (Arm II)|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
401626|NCT00616967|P2|Participant Flow|Placebo (Arm I)|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
401627|NCT00616967|P1|Participant Flow|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
401628|NCT00616967|O2|Outcome|Non-Responders|Pooled data from participants who did not receive a pathologic complete response across arms.
401629|NCT00616967|O1|Outcome|Responders|Pooled data from participants who received a pathologic complete response across arms.
401630|NCT00616967|O2|Outcome|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
401652|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged >64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401632|NCT00616967|E3|Reported Event|Arm II|"Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally"
401633|NCT00616967|E2|Reported Event|Arm I|"Patients receive carboplatin IV and paclitaxel albumin-stabilized nanoparticle formulation IV on day 1 and an oral placebo on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~placebo: Given orally"
401634|NCT00616967|E1|Reported Event|Run-in Phase (Arm 0)|"Phase 0 - To confirm safety and dosing prior to moving to randomized phase 2 portion (Arms 1 and 2).~Patients receive carboplatin and paclitaxel albumin-stabilized nanoparticle formulation as in arm I and oral vorinostat on days 1-3. Treatment repeats weekly for 12 weeks in the absence of disease progression or unacceptable toxicity.~carboplatin: Given IV~paclitaxel albumin-stabilized nanoparticle formulation: Given IV~vorinostat: Given orally~Events summarized in this arm are those that met 5% reporting threshold in Arms I and II."
401635|NCT00616928|B5|Baseline|Total|Total of all reporting groups
401636|NCT00616928|B4|Baseline|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401637|NCT00616928|B3|Baseline|Influenza A (H5N1) >64Y Group|Influenza A (H5N1) >64Y Group Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401638|NCT00616928|B2|Baseline|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401639|NCT00616928|B1|Baseline|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401640|NCT00616928|P4|Participant Flow|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401641|NCT00616928|P3|Participant Flow|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401642|NCT00616928|P2|Participant Flow|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401643|NCT00616928|P1|Participant Flow|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401644|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401645|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401646|NCT00616928|O2|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401647|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401648|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401649|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401650|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401651|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401732|NCT00616772|B2|Baseline|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401799|NCT00616655|E1|Reported Event|Placebo Arm|Placebo
401653|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401654|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401655|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401656|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401657|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401658|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401659|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401660|NCT00616928|O4|Outcome|Placebo ˃ 64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401661|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401662|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401663|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401664|NCT00616928|O4|Outcome|Placebo >60Y Group|Subjects aged > 60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401665|NCT00616928|O3|Outcome|Influenza A (H5N1) >60Y Group|Subjects aged >60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401666|NCT00616928|O2|Outcome|Placebo 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401667|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-60Y Group|Subjects aged 18-60 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401668|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401669|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401670|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401671|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401672|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401673|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401733|NCT00616772|B1|Baseline|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401674|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401675|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401676|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401677|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401678|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401679|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401680|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401681|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401682|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401683|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401684|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401685|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401686|NCT00616928|O6|Outcome|Placebo Group|Pooled group of subjects aged >18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401687|NCT00616928|O5|Outcome|Influenza A (H5N1) Group|Pooled group of subjects aged >18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401688|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401689|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401690|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401691|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
401692|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401693|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401694|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401734|NCT00616772|P2|Participant Flow|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401800|NCT00616642|B3|Baseline|Total|Total of all reporting groups
401695|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm
401696|NCT00616928|O4|Outcome|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401697|NCT00616928|O3|Outcome|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401698|NCT00616928|O2|Outcome|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401699|NCT00616928|O1|Outcome|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401700|NCT00616928|E4|Reported Event|Placebo >64Y Group|Subjects aged > 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401701|NCT00616928|E3|Reported Event|Influenza A (H5N1) >64Y Group|Subjects aged > 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401702|NCT00616928|E2|Reported Event|Placebo 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401703|NCT00616928|E1|Reported Event|Influenza A (H5N1) 18-64Y Group|Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
401704|NCT00616902|B3|Baseline|Total|Total of all reporting groups
401705|NCT00616902|B2|Baseline|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401706|NCT00616902|B1|Baseline|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401707|NCT00616902|P2|Participant Flow|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401708|NCT00616902|P1|Participant Flow|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401709|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401710|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401711|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401712|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401713|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401714|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401715|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401716|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401717|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401718|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401719|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401720|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401721|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401722|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401723|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401724|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401725|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401726|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401727|NCT00616902|O2|Outcome|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401728|NCT00616902|O1|Outcome|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401729|NCT00616902|E2|Reported Event|Placebo Injection 4 Mcg/mL|Placebo Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401730|NCT00616902|E1|Reported Event|Paricalcitol Injection 4 Mcg/mL|Paricalcitol Injection 4 mcg/mL given intravenously 3 times per week during dialysis.
401731|NCT00616772|B3|Baseline|Total|Total of all reporting groups
401736|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401737|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401738|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401739|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401740|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401741|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401742|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401743|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401744|NCT00616772|O2|Outcome|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401745|NCT00616772|O1|Outcome|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401746|NCT00616772|E2|Reported Event|Placebo + Atorvastatin|Placebo and atorvastatin (up to 40 mg) once daily for 2 years.
401747|NCT00616772|E1|Reported Event|ABT-335 + Atorvastatin|ABT-335 (135 mg) and atorvastatin (up to 40 mg) once daily for 2 years.
401748|NCT00616759|B3|Baseline|Total|Total of all reporting groups
401749|NCT00616759|B2|Baseline|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
401750|NCT00616759|B1|Baseline|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
401751|NCT00616759|P2|Participant Flow|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
401752|NCT00616759|P1|Participant Flow|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
401753|NCT00616759|O2|Outcome|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
401754|NCT00616759|O1|Outcome|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
401755|NCT00616759|E2|Reported Event|6 ECTs Where Seizure Was Shortened by Propofol|ECT-induced seizures terminated with propofol
401756|NCT00616759|E1|Reported Event|Series of 6 ECTs Performed With Standard Technique|Electroconvulsive Therapy (ECT) as usual
401757|NCT00616655|B4|Baseline|Total|Total of all reporting groups
401758|NCT00616655|B3|Baseline|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401759|NCT00616655|B2|Baseline|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401760|NCT00616655|B1|Baseline|Placebo Arm|Placebo
401761|NCT00616655|P3|Participant Flow|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401762|NCT00616655|P2|Participant Flow|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401763|NCT00616655|P1|Participant Flow|Placebo Arm|Placebo
401764|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401765|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401766|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401767|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401768|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401769|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401770|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401771|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401772|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401773|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401774|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401775|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401776|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401777|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401778|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401779|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401780|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401781|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401782|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401783|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401784|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401785|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401786|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401787|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401788|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401789|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401790|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401791|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401792|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401793|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401794|NCT00616655|O3|Outcome|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401795|NCT00616655|O2|Outcome|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401796|NCT00616655|O1|Outcome|Placebo Arm|Placebo
401797|NCT00616655|E3|Reported Event|Eszopiclone High Dose Arm|SEP-225441 (eszopiclone) total daily dose of 1.5 mg
401798|NCT00616655|E2|Reported Event|Eszopiclone Low Dose Arm|SEP-225441 (eszopiclone) total daily dose of 0.9 mg
401801|NCT00616642|B2|Baseline|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401802|NCT00616642|B1|Baseline|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401803|NCT00616642|P2|Participant Flow|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401804|NCT00616642|P1|Participant Flow|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401805|NCT00616642|O2|Outcome|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401806|NCT00616642|O1|Outcome|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401807|NCT00616642|E2|Reported Event|Group 2 (Non-secreting Macroadenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 12 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401808|NCT00616642|E1|Reported Event|Group 1 (ACTH-secreting Adenomas)|"Patients receive 4 mg oral rosiglitazone maleate once daily in week 1 and then 8 mg once daily beginning in week 2 and continuing for up to 6 months in the absence of disease progression or unacceptable toxicity.~rosiglitazone maleate : Given orally"
401809|NCT00616629|B6|Baseline|Total|Total of all reporting groups
401810|NCT00616629|B5|Baseline|Placebo|Corresponding placebo
401811|NCT00616629|B4|Baseline|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401812|NCT00616629|B3|Baseline|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401813|NCT00616629|B2|Baseline|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401814|NCT00616629|B1|Baseline|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401815|NCT00616629|P5|Participant Flow|Placebo|Corresponding placebo
401816|NCT00616629|P4|Participant Flow|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401817|NCT00616629|P3|Participant Flow|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401818|NCT00616629|P2|Participant Flow|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401819|NCT00616629|P1|Participant Flow|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401820|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401821|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401822|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401823|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401824|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401825|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401826|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401827|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401828|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401829|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401830|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401831|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401832|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401833|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401834|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401835|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401836|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401837|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401838|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401839|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401840|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401841|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401842|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401843|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401844|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401845|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401846|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401847|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401848|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401849|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401850|NCT00616629|O5|Outcome|Placebo|Corresponding placebo
401851|NCT00616629|O4|Outcome|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401852|NCT00616629|O3|Outcome|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401853|NCT00616629|O2|Outcome|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401854|NCT00616629|O1|Outcome|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401855|NCT00616629|E5|Reported Event|Placebo|Corresponding placebo
401856|NCT00616629|E4|Reported Event|AZD1305 Dose Group 4|Loading dose 15 min at 488.8 mg/h, Maintenance dose maximum 60 additional min at 220.0 mg/h
401857|NCT00616629|E3|Reported Event|AZD1305 Dose Group 3|Loading dose 15 min at 325.9 mg/h, Maintenance dose maximum 60 additional min at 146.6 mg/h
401858|NCT00616629|E2|Reported Event|AZD1305 Dose Group 2|Loading dose 15 min at 130.4 mg/h, Maintenance dose maximum 60 additional min at 58.7 mg/h
401859|NCT00616629|E1|Reported Event|AZD1305 Dose Group 1|Loading dose 15 min at 43.5 mg/h, Maintenance dose maximum 60 additional min at 19.6 mg/h
401860|NCT00616603|B4|Baseline|Total|Total of all reporting groups
401861|NCT00616603|B3|Baseline|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
401862|NCT00616603|B2|Baseline|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
401863|NCT00616603|B1|Baseline|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
401864|NCT00616603|P3|Participant Flow|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
401865|NCT00616603|P2|Participant Flow|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
401866|NCT00616603|P1|Participant Flow|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
401867|NCT00616603|O3|Outcome|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
401868|NCT00616603|O2|Outcome|Group B|Subjects in Group B will have 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml of normal saline
401869|NCT00616603|O1|Outcome|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal sali
401870|NCT00616603|E3|Reported Event|Group C|Subjects in Group C will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV (8mg)of Dexamethasone.
401871|NCT00616603|E2|Reported Event|Group A|This is the control arm and subjects in Group A will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 2ml IV of normal saline.
401872|NCT00616603|E1|Reported Event|Group B|Subjects in Group B will have sciatic nerve block with 20ml of 0.2% Ropivacaine + 8mg Dexamethasone + 2ml IV of normal saline.
401873|NCT00616577|B4|Baseline|Total|Total of all reporting groups
401874|NCT00616577|B3|Baseline|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
401875|NCT00616577|B2|Baseline|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401876|NCT00616577|B1|Baseline|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401877|NCT00616577|P3|Participant Flow|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
401878|NCT00616577|P2|Participant Flow|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401879|NCT00616577|P1|Participant Flow|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401880|NCT00616577|O3|Outcome|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
401921|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
401881|NCT00616577|O2|Outcome|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401882|NCT00616577|O1|Outcome|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401883|NCT00616577|E3|Reported Event|Group LIA|"Group LIA (Local Infiltration After—control group) will receive local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site at the conclusion of surgery but before emergence from anesthesia.~Ropivacaine: local infiltration of ropivacaine 0.25% up to 1ml/kg (maximum 15ml) around the surgery site"
401884|NCT00616577|E2|Reported Event|Group CA|"Group CA (Caudal After—control group) will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after completion of surgery but before emergence from anesthesia.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401885|NCT00616577|E1|Reported Event|Group CB|"Subjects in this arm will receive caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine after induction of general anesthesia prior to surgical incision.~Ropivacaine: caudal ropivacaine 0.25% at a dose of 1ml/kg (maximum 15ml) with 1:200,000 epinephrine"
401886|NCT00616434|B3|Baseline|Total|Total of all reporting groups
401887|NCT00616434|B2|Baseline|Placebo|Placebo IM injection twice weekly for 12 weeks
401888|NCT00616434|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401889|NCT00616434|P2|Participant Flow|Placebo|Placebo IM injection twice weekly for 12 weeks
401890|NCT00616434|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401891|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
401892|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401893|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
401894|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401895|NCT00616434|O2|Outcome|Placebo|Placebo IM injection twice weekly for 12 weeks
401896|NCT00616434|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401897|NCT00616434|E2|Reported Event|Placebo|Placebo IM injection twice weekly for 12 weeks
401898|NCT00616434|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 30 µg intramuscular (IM) injection twice weekly for 12 weeks
401899|NCT00616421|B4|Baseline|Total|Total of all reporting groups
401900|NCT00616421|B3|Baseline|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1.
401901|NCT00616421|B2|Baseline|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day1.
401902|NCT00616421|B1|Baseline|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered on study days 1 and 61 in children 2 to 5 years of age.
401903|NCT00616421|P3|Participant Flow|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401904|NCT00616421|P2|Participant Flow|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study day 1
401905|NCT00616421|P1|Participant Flow|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) vaccine administered by intramuscular (IM) injection on study days 1 and 61 in children 2 to 5 years of age
401906|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401907|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401908|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 6 to 10 years of age.
401909|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 6 to 10 years of age.
401910|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (1 Dose)|The licensed meningococcal MenACWY polysaccharide vaccine was administered by IM in children 2 to 5 years of age.
401911|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|The Novartis MenACWY-CRM vaccine was administered by IM in children 2 to 5 years of age.
401912|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
401913|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
401914|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
401915|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
401916|NCT00616421|O2|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age
401917|NCT00616421|O1|Outcome|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
401918|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 6 to 10 years of age
401919|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
401920|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age
401922|NCT00616421|O4|Outcome|Licensed Polysaccharide Vaccine (6 to 10 Yoa)|1 injection of the licensed meningococcal ACWY polysaccharide-protein conjugate administered by IM on study day 1 in children 6 to 10 years of age.
401923|NCT00616421|O3|Outcome|MenACWY-CRM (6 to 10 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 6 to 10 years of age.
401924|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine (2 to 5 Yoa)|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered by IM on study day 1 in children 2 to 5 years of age.
401925|NCT00616421|O1|Outcome|MenACWY-CRM (2 to 5 Yoa)|1 injection of the Novartis MenACWY-CRM vaccine administered by IM on study day 1 in children 2 to 5 years of age.
401926|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401927|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401928|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401929|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401930|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401931|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401932|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401933|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401934|NCT00616421|O2|Outcome|Licensed Polysaccharide Vaccine|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1
401935|NCT00616421|O1|Outcome|MenACWY-CRM (1 Dose)|1 injection of the Novartis MenACWY-CRM (a nontoxic diptheria toxin) vaccine administered on study day 1
401936|NCT00616421|E5|Reported Event|Licensed Polysaccharide Vaccine_6 to 10 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 6 to 10 years of age.
401937|NCT00616421|E4|Reported Event|Licensed Polysaccharide Vaccine_2 to 5 Years|1 injection of the licensed meningococcal MenACWY polysaccharide vaccine administered on study day 1 in children 2 to 5 years of age.
401938|NCT00616421|E3|Reported Event|MenACWY-CRM (1 Dose)_6 to 10 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 6 to 10 years of age.
401939|NCT00616421|E2|Reported Event|MenACWY-CRM (1 Dose)_2 to 5 Years|1 injection of the Novartis MenACWY-CRM vaccine administered on study day 1 in children 2 to 5 years of age.
401940|NCT00616421|E1|Reported Event|MenACWY-CRM (2 Doses)|2 injections of the Novartis MenACWY-CRM vaccine administered by IM on study days 1 and 61 in children 2 to 5 years of age
401941|NCT00616343|B1|Baseline|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
401942|NCT00616343|P1|Participant Flow|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
401943|NCT00616343|O1|Outcome|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
401944|NCT00616343|E1|Reported Event|Zonisamide|Zonisamide: 100mg tablets once a day for two weeks, then increased to 200mg qhs for two weeks.
401945|NCT00616239|B1|Baseline|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
401946|NCT00616239|P1|Participant Flow|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
401947|NCT00616239|O1|Outcome|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
401948|NCT00616239|E1|Reported Event|20% to 30% Salicylic Acid Peels + 4% Hydroquinone Cream|Subjects randomized to have the right side of the face peeled with salicylic acid every 2 weeks for a total of 4 peels (first 2 at 20% and last 2 at 30%). Subjects will apply 4% hydroquinone cream to affected areas on entire face for 14 weeks.
401949|NCT00614198|B3|Baseline|Total|Total of all reporting groups
401950|NCT00614198|B2|Baseline|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
401951|NCT00614198|B1|Baseline|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
401952|NCT00614198|P2|Participant Flow|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
401953|NCT00614198|P1|Participant Flow|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
402016|NCT00615836|B5|Baseline|Total|Total of all reporting groups
402017|NCT00615836|B4|Baseline|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
401954|NCT00614198|O2|Outcome|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
401955|NCT00614198|O1|Outcome|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
401956|NCT00614198|E2|Reported Event|No Gluten- and Casein-free Dietary Intervention|Stage 1: No special dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If dietary intervention group showed group significant improvement progressed to stage 2 (introduction of a gluten- and casein-free diet for 12 months).
401957|NCT00614198|E1|Reported Event|Gluten- and Casein-free Dietary Intervention|Stage 1: Gluten- and casein-free dietary intervention for first 8 or 12 months. 8 or 12 months: Interim analysis based on surpassing statistical thresholds. If showed group significant improvement progressed to stage 2 (continued on a gluten- and casein-free diet for a further 12 months).
401958|NCT00616200|B1|Baseline|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
401959|NCT00616200|P1|Participant Flow|Standard Diet Then Very Low Carbohydrate Diet|Two weeks of a carbohydrate rich diet was followed by four weeks of A Very Low Carbohydrate Diet. VLCD = <20g/day of carbohydrates
401960|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
401961|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
401962|NCT00616200|O1|Outcome|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
401963|NCT00616200|E1|Reported Event|Four Week Very Low Carbohydrate Diet|A Very Low Carbohydrate Diet was administered for four weeks. VLCD = <20g/day of carbohydrates
401964|NCT00616122|B1|Baseline|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401965|NCT00616122|P1|Participant Flow|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401966|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401967|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401968|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401969|NCT00616122|O1|Outcome|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401970|NCT00616122|E1|Reported Event|Sunitinib, Cyclophosphamide, and Methotrexate|Phase I patients received escalating doses of sunitinib in a 3x3 design (12.5, 25, 37.5 mg). Phase I and II patients received sunitinib for 2 weeks, followed by the addition of metronomic cyclophosphamide (50mg/day) and methotrexate (2.5mg BID 2 days/week). Phase II patients received 37.5mg sunitinib during the 2-week lead-in period followed by either 37.5mg sunitinib and metronomic CM or 25mg sunitinib and metronomic CM (dose reduction due to a protocol amendment).
401971|NCT00616109|B1|Baseline|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
401972|NCT00616109|P1|Participant Flow|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
401973|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
402112|NCT00615550|E1|Reported Event|Placebo|placebo vaginal gel
401974|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
401975|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
401976|NCT00616109|O1|Outcome|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy. All patients who have received at least one cycle of sunitinib will be considered evaluable for response.
401977|NCT00616109|E1|Reported Event|Sunitinib Maintenance Therapy|Sunitinib 50 mg po QD × 28 days followed by a 14 day break every 42 days until disease progression or unacceptable toxicity. Treatment to begin 28-42 days after day 1 of the last cycle of induction chemotherapy to allow confirmation of response or disease stability with chemotherapy.
401978|NCT00616018|B1|Baseline|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
401979|NCT00616018|P1|Participant Flow|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
401980|NCT00616018|O1|Outcome|Acetaminophen|acetaminophen treatment group
401981|NCT00616018|O1|Outcome|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
401982|NCT00616018|E1|Reported Event|Acetaminophen|all subjects receive 4 g/day of acetaminophen for 10 consecutive days in this open-label study
401983|NCT00615992|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401984|NCT00615992|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401985|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401986|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401987|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401988|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401989|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401990|NCT00615992|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401991|NCT00615992|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18μg inhalation capsules once-daily
401992|NCT00615927|B3|Baseline|Total|Total of all reporting groups
401993|NCT00615927|B2|Baseline|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
401994|NCT00615927|B1|Baseline|Astrocytoma|Grade II Astrocytoma
401995|NCT00615927|P2|Participant Flow|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
401996|NCT00615927|P1|Participant Flow|Astrocytoma|Grade II Astrocytoma
401997|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
401998|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
401999|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
402000|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
402001|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
402002|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
402003|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
402004|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
402005|NCT00615927|O2|Outcome|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
402006|NCT00615927|O1|Outcome|Astrocytoma|Grade II Astrocytoma
402007|NCT00615927|E2|Reported Event|Oligodendroglioma|Grade II Oligodendroglioma or oligoastrocytomas
402008|NCT00615927|E1|Reported Event|Astrocytoma|Grade II Astrocytoma
402009|NCT00615914|B1|Baseline|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated until symptom control was achieved. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402010|NCT00615914|P1|Participant Flow|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg)
402011|NCT00615914|O1|Outcome|Pramipexole|Pramipexole tablets were administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402012|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402013|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402014|NCT00615914|O1|Outcome|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402015|NCT00615914|E1|Reported Event|Pramipexole|Pramipexole tablets - oral administration (0.125 mg and 0.5 mg) was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
402018|NCT00615836|B3|Baseline|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402019|NCT00615836|B2|Baseline|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402020|NCT00615836|B1|Baseline|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402021|NCT00615836|P5|Participant Flow|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of Study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt, continuing into Study CS31.
402022|NCT00615836|P4|Participant Flow|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
402023|NCT00615836|P3|Participant Flow|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
402024|NCT00615836|P2|Participant Flow|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29 and for up to 2 years and 2.5 months in Study CS31.
402025|NCT00615836|P1|Participant Flow|Desmopressin Melt 10 μg|"Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime for between 2-7 months in Study CS29, continuing in Study CS31.~During CS31, based on the results of CS29, participants were randomly assigned to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg)."
402026|NCT00615836|O5|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402027|NCT00615836|O4|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402028|NCT00615836|O3|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402029|NCT00615836|O2|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402030|NCT00615836|O1|Outcome|Placebo|Participants took a placebo 'Melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to 1 of the other 4 treatment arms to receive active desmopressin Melt.
402031|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402032|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402033|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402034|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402035|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402036|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402037|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402038|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402039|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402040|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402041|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402042|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402043|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402044|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402045|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402046|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402047|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402048|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402049|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402050|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402051|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402052|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402053|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402054|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402055|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402056|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402057|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402058|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402059|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402060|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402061|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402062|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402063|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402064|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402065|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402066|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402067|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402068|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402069|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402070|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402071|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402072|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402073|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402074|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402075|NCT00615836|O4|Outcome|Desmopressin Melt 100 μg|Participants received desmopressin Melt 100 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402076|NCT00615836|O3|Outcome|Desmopressin Melt 50 μg|Participants received desmopressin Melt 50 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402077|NCT00615836|O2|Outcome|Desmopressin Melt 25 μg|Participants received desmopressin Melt 25 μg once a day, placed under the tongue 1 hour before bedtime for up to 2 years and 2.5 months.
402078|NCT00615836|O1|Outcome|Desmopressin Melt 10 μg|Participants received desmopressin Melt 10 μg once a day, placed under the tongue 1 hour before bedtime until they were re-randomized to 1 of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402079|NCT00615836|E5|Reported Event|Desmopressin Melt 100 μg|Participants received desmopressin melt 100 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402113|NCT00615472|B3|Baseline|Total|Total of all reporting groups
402080|NCT00615836|E4|Reported Event|Desmopressin Melt 50 μg|Participants received desmopressin melt 50 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402081|NCT00615836|E3|Reported Event|Desmopressin Melt 25 μg|Participants received desmopressin melt 25 μg once a day, in CS29 or CS31. This group includes participants initially randomized to placebo and re-randomized at the end of CS29 Part I and participants initially receiving 10 μg re-randomized during CS31.
402082|NCT00615836|E2|Reported Event|Desmopressin Melt 10 μg|Participants received desmopressin melt 10 μg once a day, in CS29 and CS31 until they were re-randomized to one of the other doses of desmopressin Melt (25 μg, 50 μg, or 100 μg).
402083|NCT00615836|E1|Reported Event|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of study CS29. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt.
402084|NCT00615719|B1|Baseline|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
402085|NCT00615719|P1|Participant Flow|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
402086|NCT00615719|O1|Outcome|Computed Tomographic Coronary Angiography for Chest Pain Evalu|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA)
402087|NCT00615719|E1|Reported Event|ED Patients Undergoing Coronary CTA|Usefulness of Computed Tomographic (CT) Coronary Angiography (CTCA) to Evaluate Emergency Department (ED) Patients With Chest Pain (EDCCTA). Patients were to undergo Coronary CT angiography in addition to the nuclear perfusion imaging performed as the standard of care.
402088|NCT00615589|B1|Baseline|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402089|NCT00615589|P1|Participant Flow|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402090|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen (Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402091|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402092|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402093|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402094|NCT00615589|O1|Outcome|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402095|NCT00615589|E1|Reported Event|Flu-Bu4|"Fludarabine Busulfan chemotherapy regimen(Flu-Bu4), followed by allogeneic stem cell transplant from best available, matched donor.~Fludarabine/Busulfan x 4 days:~Fludarabine: 40 mg/m2/day in NS, administered IV over 30 minutes on days –5, -4, -3, and –2 pre-transplant.~Busulfan: 3.2 mg/kg IV daily in NS over 4 hours on days –5, –4, -3, and –2.~The Fludarabine shall be administered prior to the Busulfan each day."
402096|NCT00615550|B3|Baseline|Total|Total of all reporting groups
402097|NCT00615550|B2|Baseline|Prochieve|Progesterone 8% Vaginal Gel
402098|NCT00615550|B1|Baseline|Placebo|placebo vaginal gel
402099|NCT00615550|P2|Participant Flow|Prochieve|Progesterone 8% Vaginal Gel
402100|NCT00615550|P1|Participant Flow|Placebo|placebo vaginal gel
402101|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
402102|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
402103|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
402104|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
402105|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
402106|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
402107|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
402108|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
402109|NCT00615550|O2|Outcome|Prochieve|Progesterone 8% Vaginal Gel
402110|NCT00615550|O1|Outcome|Placebo|placebo vaginal gel
402111|NCT00615550|E2|Reported Event|Prochieve|Progesterone 8% Vaginal Gel
402114|NCT00615472|B2|Baseline|Intravenous Anesthesia|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed"
402115|NCT00615472|B1|Baseline|Inhaled Anesthesia|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
402116|NCT00615472|P2|Participant Flow|Intravenous Anesthesia|Intravenous Anesthesia - propofol, remifentanil
402117|NCT00615472|P1|Participant Flow|Inhaled Anesthesia|Inhaled Anesthesia - isoflurane
402118|NCT00615472|O2|Outcome|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
402119|NCT00615472|O1|Outcome|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
402120|NCT00615472|E2|Reported Event|Group 2|"Intravenous Anesthesia - propofol, remifentanil~Remifentanil: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min.~Propofol: Group 2 Intravenous anesthesia Patients will be ventilated with 50% oxygen in air. Patients will receive continuous propofol infusion 0.05 mg/kg-min to 0.15 mg/kg-min titrated as needed; and remifentanil (ultra-short acting narcotic) 0.1 ug/kg-min to 0.5 ug/kg-min."
402121|NCT00615472|E1|Reported Event|Group 1|"Inhaled Anesthesia - isoflurane~Isoflurane: Group 1 Inhaled anesthesia Patients will be maintained on 50% oxygen in air and isoflurane 0 to 4%, titrated as needed to maintain a standard blood pressure (standard practice). If needed, muscle relaxation will be provided by additional boluses or an infusion of mivacurium (4-10 ug/kg/min)."
402122|NCT00615459|B1|Baseline|Total Patients|The safety population, included all patients who received at least one dose of study drug.
402123|NCT00615459|P4|Participant Flow|Sequence 4: Tiotropium, Placebo, Indacaterol 300 μg|In period I, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. In period II, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period III, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402124|NCT00615459|P3|Participant Flow|Sequence 3: Indacaterol 150 μg, Indacaterol 300 μg, Placebo|In period I, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 300 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402125|NCT00615459|P2|Participant Flow|Sequence 2: Indacaterol 300 μg, Indacaterol 150 μg, Tiotropium|In period I,indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period II, indacaterol 150 μg once daily delivered via SDDPI and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. In period III, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via SDDPI. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402126|NCT00615459|P1|Participant Flow|Sequence 1: Placebo,Tiotropium, Indacaterol 150 μg|In period I, placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. In period II, tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). In period III, indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402127|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402128|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402129|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402973|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402130|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402131|NCT00615459|O4|Outcome|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402132|NCT00615459|O3|Outcome|Tiotropium 18 μg|Tiotropium (18 μg) once daily delivered via inhalation device and matching placebo to indacaterol delivered once daily via single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402133|NCT00615459|O2|Outcome|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI)and matching placebo to tiotropium delivered once daily via tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402134|NCT00615459|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via SDDPI and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The Short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402135|NCT00615459|E4|Reported Event|Placebo|Placebo to indacaterol (150 or 300 μg) delivered via SDDPI. The placebo for blinding tiotropium was delivered via the tiotropium inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402136|NCT00615459|E3|Reported Event|Tiotropium 18 μg|Tiotropium 18 μg once daily delivered via inhalation device. Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402137|NCT00615459|E2|Reported Event|Indacaterol 300 μg|Indacaterol 300 μg once daily delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy (where applicable) was provided to remain stable throughout study. The SABA was available for rescue use throughout the study.
402138|NCT00615459|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily delivered via single dose dry powder inhaler (SDDPI) and placebo to tiotropium was delivered once daily via the tiotropium inhalation device. Daily inhaled corticosteroid (ICS) monotherapy (where applicable) was provided to remain stable throughout study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402139|NCT00615433|B5|Baseline|Total|Total of all reporting groups
402140|NCT00615433|B4|Baseline|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
402141|NCT00615433|B3|Baseline|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
402142|NCT00615433|B2|Baseline|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
402143|NCT00615433|B1|Baseline|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
402144|NCT00615433|P4|Participant Flow|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
402145|NCT00615433|P3|Participant Flow|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
402146|NCT00615433|P2|Participant Flow|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
402147|NCT00615433|P1|Participant Flow|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
402148|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
402181|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402182|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402183|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402149|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
402150|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
402151|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
402152|NCT00615433|O4|Outcome|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
402153|NCT00615433|O3|Outcome|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
402154|NCT00615433|O2|Outcome|120mg|3 40 mg tablets taken orally once a day.
402155|NCT00615433|O1|Outcome|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
402156|NCT00615433|E4|Reported Event|Placebo|Placebo to match lurasidone 40mg (tablets or placebo to match olanzapine 5 mg (over-encapsulated).
402157|NCT00615433|E3|Reported Event|15mg Olz|3 5 mg Olanzapine over-encapsulated capsules taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 15 mg Olanzapine treatment group did not take any study medication.
402158|NCT00615433|E2|Reported Event|120mg|3 40 mg tablets taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 120 mg treatment group did not take any study medication.
402159|NCT00615433|E1|Reported Event|40mg|Lurasidone 40 mg tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (478). The number of subjects in the baseline characteristics is based on the safety population (475). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 40 mg treatment group did not take any study medication.
402160|NCT00614120|B5|Baseline|Total|Total of all reporting groups
402161|NCT00614120|B4|Baseline|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402162|NCT00614120|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402163|NCT00614120|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402164|NCT00614120|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402165|NCT00614120|P4|Participant Flow|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402166|NCT00614120|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402167|NCT00614120|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402168|NCT00614120|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402169|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402170|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402171|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402172|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402173|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402174|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402175|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402176|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402177|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402178|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402179|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402180|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402369|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
402184|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402185|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402186|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402187|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402188|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402189|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402190|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402191|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402192|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402193|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402194|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402195|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402196|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402197|NCT00614120|O4|Outcome|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402198|NCT00614120|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402199|NCT00614120|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402200|NCT00614120|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402201|NCT00614120|E4|Reported Event|Glim + Met|Glimepiride 4.0 mg + metformin 1.5-2.0 g daily + liraglutide placebo
402202|NCT00614120|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402203|NCT00614120|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402204|NCT00614120|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg once daily + metformin 1.5-2.0 g daily + glimepiride placebo
402205|NCT00614055|B4|Baseline|Total|Total of all reporting groups
402206|NCT00614055|B3|Baseline|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402207|NCT00614055|B2|Baseline|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402208|NCT00614055|B1|Baseline|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402209|NCT00614055|P3|Participant Flow|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402210|NCT00614055|P2|Participant Flow|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402211|NCT00614055|P1|Participant Flow|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402212|NCT00614055|O3|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402213|NCT00614055|O2|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402214|NCT00614055|O1|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402215|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402216|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402217|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402218|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402370|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
402371|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
402219|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402220|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402221|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402222|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402223|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402224|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402225|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402226|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402227|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402228|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402229|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402230|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402231|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402232|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402233|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402234|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402235|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402236|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402237|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402238|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402239|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402240|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402372|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
402241|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402242|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402243|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402244|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402245|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402246|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402247|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402248|NCT00614055|O3|Outcome|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402249|NCT00614055|O2|Outcome|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402250|NCT00614055|O1|Outcome|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402251|NCT00614055|E3|Reported Event|Insulin Glargine|Insulin glargine was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402252|NCT00614055|E2|Reported Event|SIAC 45 (B)|Soluble insulin analogue combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402253|NCT00614055|E1|Reported Event|SIAC 30 (B)|Soluble insulin analogue combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml; formulation B) was given subcutaneously once daily (OD) before dinner in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402254|NCT00613951|B4|Baseline|Total|Total of all reporting groups
402255|NCT00613951|B3|Baseline|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402256|NCT00613951|B2|Baseline|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402257|NCT00613951|B1|Baseline|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402258|NCT00613951|P3|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402259|NCT00613951|P2|Participant Flow|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402260|NCT00613951|P1|Participant Flow|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402261|NCT00613951|O3|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402262|NCT00613951|O2|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402263|NCT00613951|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402264|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402265|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402266|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402267|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402268|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402269|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402270|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402271|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402272|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402273|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402274|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402275|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402276|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402277|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402278|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402279|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402280|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402281|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402282|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402283|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402373|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
402284|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402285|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402286|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402287|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402288|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402289|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402290|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402291|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402292|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402293|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402294|NCT00613951|O3|Outcome|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402295|NCT00613951|O2|Outcome|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402296|NCT00613951|O1|Outcome|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402297|NCT00613951|E3|Reported Event|BIAsp 30|Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402298|NCT00613951|E2|Reported Event|SIAC 45 (B)|Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402299|NCT00613951|E1|Reported Event|SIAC 30 (B)|Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted.
402300|NCT00615290|B1|Baseline|Aptivus|Patients treated by Aptivus in daily practice
402301|NCT00615290|P1|Participant Flow|Aptivus|Patients treated by Aptivus in daily practice
402302|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402303|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402304|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402305|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402306|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402307|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402308|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402309|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402310|NCT00615290|O1|Outcome|Aptivus|Patients treated by Aptivus in daily practice
402311|NCT00615290|E1|Reported Event|Aptivus|Patients treated by Aptivus in daily practice
402312|NCT00615264|B3|Baseline|Total|Total of all reporting groups
402313|NCT00615264|B2|Baseline|Placebo|"Mannitol 40 mg in 0.5 mL Lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
402374|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
402314|NCT00615264|B1|Baseline|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5mL Lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
402315|NCT00615264|P2|Participant Flow|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
402316|NCT00615264|P1|Participant Flow|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
402317|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
402318|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
402319|NCT00615264|O2|Outcome|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
402320|NCT00615264|O1|Outcome|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
402321|NCT00615264|E2|Reported Event|Placebo|"Mannitol 40 mg in 0.5 mL lipid emulsion.~Placebo: Mannitol (excipient) 40 mg, administered as subcutaneous injection on 1, 3, 6, 9, 12, 15, 18 and 21 months."
402322|NCT00615264|E1|Reported Event|DiaPep277|"DiaPep277 1.0 mg + 40 mg Mannitol in 0.5 mL lipid emulsion.~DiaPep277: 1.0 mg dose, administered as subcutaneous injection, on 0, 1, 3, 6, 9, 12, 15, 18 and 21 months"
402323|NCT00615199|B5|Baseline|Total|Total of all reporting groups
402324|NCT00615199|B4|Baseline|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402325|NCT00615199|B3|Baseline|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402326|NCT00615199|B2|Baseline|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402327|NCT00615199|B1|Baseline|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402328|NCT00615199|P4|Participant Flow|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402329|NCT00615199|P3|Participant Flow|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402330|NCT00615199|P2|Participant Flow|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402331|NCT00615199|P1|Participant Flow|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402332|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402333|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402334|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402335|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402336|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402337|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402338|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402339|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402340|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402341|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402342|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402343|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402344|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402345|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402346|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402347|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402348|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402349|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402350|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402351|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402352|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402353|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402354|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402355|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402356|NCT00615199|O4|Outcome|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402357|NCT00615199|O3|Outcome|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402358|NCT00615199|O2|Outcome|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402359|NCT00615199|O1|Outcome|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402360|NCT00615199|E4|Reported Event|CP-690550 15 mg|CP-690550 15 mg tablet orally twice daily for 4 weeks.
402361|NCT00615199|E3|Reported Event|CP-690550 5 mg|CP-690550 5 mg tablet orally twice daily for 4 weeks.
402362|NCT00615199|E2|Reported Event|CP-690550 1 mg|CP-690550 1 milligram (mg) tablet orally twice daily for 4 weeks.
402363|NCT00615199|E1|Reported Event|Placebo|Placebo tablet matched to CP-690550 orally twice daily for 4 weeks.
402364|NCT00615108|B1|Baseline|Hypertension Patients|Telmisartan 40mg or 80 mg
402365|NCT00615108|P1|Participant Flow|Hypertension Patients|Telmisartan 40mg or 80 mg
402366|NCT00615108|O3|Outcome|Total|Telmisartan 40mg or 80 mg
402367|NCT00615108|O2|Outcome|Micardis 80mg|Telmisartan 80 mg
402368|NCT00615108|O1|Outcome|Micardis 40mg|Telmisartan 40 mg
402379|NCT00615069|B1|Baseline|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment.
402380|NCT00615069|P1|Participant Flow|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up, however, total subject follow up is 5 years post treatment. Participant Flow results reflect the final (5 year) data.
402381|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
402382|NCT00615069|O1|Outcome|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA). This study was designed for primary analysis following one year of follow up.
402383|NCT00615069|E1|Reported Event|31 mm GORE EXCLUDER® Test Subjects|GORE EXCLUDER® AAA Endoprosthesis - 31 mm device implanted for the primary treatment of infrarenal abdominal aortic aneurysms (AAA).
402384|NCT00615056|B5|Baseline|Total|Total of all reporting groups
402385|NCT00615056|B4|Baseline|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402386|NCT00615056|B3|Baseline|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402387|NCT00615056|B2|Baseline|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402388|NCT00615056|B1|Baseline|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402389|NCT00615056|P4|Participant Flow|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402390|NCT00615056|P3|Participant Flow|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402391|NCT00615056|P2|Participant Flow|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402392|NCT00615056|P1|Participant Flow|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402393|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402394|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402395|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402396|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402458|NCT00615017|P1|Participant Flow|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402397|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402398|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402399|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402400|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402401|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402402|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402403|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402404|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402405|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402406|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402407|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402408|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402409|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402410|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402411|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402454|NCT00615017|P5|Participant Flow|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402455|NCT00615017|P4|Participant Flow|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402459|NCT00615017|O6|Outcome|Placebo|Placebo
402412|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402413|NCT00615056|O4|Outcome|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402414|NCT00615056|O3|Outcome|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402415|NCT00615056|O2|Outcome|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402416|NCT00615056|O1|Outcome|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402417|NCT00615056|E4|Reported Event|Bevacizumab + FOLFOX|Bevacizumab 5mg/kg 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFOX regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402418|NCT00615056|E3|Reported Event|Axitinib + FOLFOX|Axitinib (AG-013736) tablet starting dose 5 mg BID along with combination chemotherapy of oxaliplatin, LV and 5-FU (FOLFOX) regimen consisting of oxaliplatin 85 mg/m^2 120 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402419|NCT00615056|E2|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab 5mg/kilogram (kg) 30-90 minutes IV infusion (based on tolerance) every 2 weeks along with FOLFIRI regimen consisting of irinotecan 180 mg/m^2 90 minutes IV infusion, concurrently with LV 400 mg/m^2 (or l-LV 200 mg /m^2) 2 hrs IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402420|NCT00615056|E1|Reported Event|Axitinib + FOLFIRI|Axitinib (AG-013736) tablet starting dose 5 milligram (mg) orally twice daily (BID) along with combination chemotherapy of irinotecan, 5- flurouracil (5-FU) and leucovorin (LV) (FOLFIRI) regimen consisting of irinotecan 180 mg per square meter (mg/m^2) 90 minutes intravenous (IV) infusion, concurrently with LV 400 mg/m^2 (or levo-leucovarin [l-LV] 200 mg /m^2) 2 hours (hrs) IV infusion followed immediately by 5-FU 400 mg/m^2 IV bolus injection and a subsequent 5-FU 2400 mg/m^2 46-48 hrs IV infusion on Day 1 of each 2 week cycle.
402421|NCT00615030|B1|Baseline|Total Patients|
402422|NCT00615030|P12|Participant Flow|Sequence 12: Placebo, Indacaterol Evening, Indacaterol Morning|In period, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402423|NCT00615030|P11|Participant Flow|Sequence 11:Salmeterol,Indacaterol Morning,Indacaterol Evening|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402424|NCT00615030|P10|Participant Flow|Sequence 10: Indacaterol Evening, Placebo, Salmeterol|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402456|NCT00615017|P3|Participant Flow|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402425|NCT00615030|P9|Participant Flow|Sequence 9:Indacaterol Morning, Salmeterol, Placebo|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402426|NCT00615030|P8|Participant Flow|Sequence 8: Placebo, Indacaterol Morning, Salmeterol|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via dry powder inhaler DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402427|NCT00615030|P7|Participant Flow|Sequence 7: Salmeterol, Indacaterol Evening, Placebo|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402428|NCT00615030|P6|Participant Flow|Sequence 6:Indacaterol Evening,Salmeterol, Indacaterol Morning|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose in evening along with placebo matching indacaterol delivered by SDDPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402429|NCT00615030|P5|Participant Flow|Sequence 5: Indacaterol Morning, Placebo, Indacaterol Evening|In period I, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402430|NCT00615030|P4|Participant Flow|Sequence 4: Placebo, Salmeterol, Indacaterol Evening|In period I, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period II, salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period III, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via dry DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402431|NCT00615030|P3|Participant Flow|Sequence 3: Salmeterol, Placebo, Indacaterol Morning|In period I, salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and the second dose was in the evening along with placebo matching indacaterol delivered by SDDPI. In period II, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. In period III, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402432|NCT00615030|P2|Participant Flow|Sequence 2:Indacaterol Evening,Indacaterol Morning, Placebo|In period I, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period II, indacaterol 300 μg once a day in the morning delivered via SDDPI with a placebo to salmeterol delivered via DPI. Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period III, during morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402457|NCT00615017|P2|Participant Flow|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402433|NCT00615030|P1|Participant Flow|Sequence 1:Indacaterol Morning,Indacaterol Evening, Salmeterol|In period I, indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. In period II, patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via SDDPI with placebo to salmeterol delivered via DPI. In period III, Salmeterol 50 μg twice daily delivered via DPI. One of the two daily doses of salmeterol was administered in the morning and second dose in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402434|NCT00615030|O6|Outcome|Placebo Evening|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402435|NCT00615030|O5|Outcome|Placebo Morning|Placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via manufacturer’s proprietary DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402436|NCT00615030|O4|Outcome|Salmeterol Evening|In the evening, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402437|NCT00615030|O3|Outcome|Salmeterol Morning|In the morning, Salmeterol 50 μg delivered via dry powder inhaler (DPI) along with placebo matching indacaterol via SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402438|NCT00615030|O2|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402439|NCT00615030|O1|Outcome|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402440|NCT00615030|O2|Outcome|Placebo|During evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402441|NCT00615030|O1|Outcome|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via single dose dry powder inhaler (SDDPI) and placebo to salmeterol delivered via dry powder inhaler (DPI). Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) was available for rescue use throughout the study.
402442|NCT00615030|E4|Reported Event|Placebo|During morning and evening, placebo matching indacaterol was delivered via SDDPI and placebo matching salmeterol was delivered via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
402443|NCT00615030|E3|Reported Event|Salmeterol|Salmeterol 50 μg twice daily delivered via dry powder inhaler (DPI). One of the two daily doses of salmeterol was administered in the morning along with placebo matching indacaterol delivered by single dose dry powder inhaler (SDDPI). The second dose of salmeterol was administered in the evening along with placebo matching indacaterol delivered by SDDPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
402444|NCT00615030|E2|Reported Event|Indacaterol Morning|Indacaterol 300 μg once a day in the morning delivered via single dose dry powder inhaler (SDDPI) with a placebo to salmeterol delivered via dry powder inhaler (DPI). Patients were also instructed to take evening doses of a placebo to indacaterol via SDDPI and placebo to salmeterol via DPI. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
402445|NCT00615030|E1|Reported Event|Indacaterol Evening|Patients were instructed to take morning doses of a placebo to indacaterol delivered via SDDPI and placebo to salmeterol delivered via DPI. Indacaterol 300 μg once a day in the evening delivered via single dose dry powder inhaler (SDDPI) with placebo to salmeterol delivered via dry powder inhaler (DPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. All patients were provided with a SABA for use (if needed) as rescue medication throughout the study.
402446|NCT00615017|B7|Baseline|Total|Total of all reporting groups
402447|NCT00615017|B6|Baseline|Placebo|Placebo
402448|NCT00615017|B5|Baseline|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402449|NCT00615017|B4|Baseline|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402450|NCT00615017|B3|Baseline|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402451|NCT00615017|B2|Baseline|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402974|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402460|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402461|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402462|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402463|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402464|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402465|NCT00615017|O6|Outcome|Placebo|Placebo
402466|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402467|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402468|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402469|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402470|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402471|NCT00615017|O6|Outcome|Placebo|Placebo
402472|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402473|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402474|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402475|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402476|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402477|NCT00615017|O6|Outcome|Placebo|Placebo
402478|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402479|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402480|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402481|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402482|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402483|NCT00615017|O6|Outcome|Placebo|Placebo
402484|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402485|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402486|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402487|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402488|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402489|NCT00615017|O6|Outcome|Placebo|Placebo
402490|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402491|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402492|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402493|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402494|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402495|NCT00615017|O6|Outcome|Placebo|Placebo
402496|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402497|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402498|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402499|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402500|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402501|NCT00615017|O6|Outcome|Placebo|Placebo
402502|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402503|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402504|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402505|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402506|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402507|NCT00615017|O6|Outcome|Placebo|Placebo
402508|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402509|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402510|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402511|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402512|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402513|NCT00615017|O6|Outcome|Placebo|Placebo
410206|NCT00594464|O3|Outcome|Rotigotine 8 mg/24h|
402514|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402515|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402516|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402517|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402518|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402519|NCT00615017|O6|Outcome|Placebo|Placebo
402520|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402521|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402522|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402523|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402524|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402525|NCT00615017|O6|Outcome|Placebo|Placebo
402526|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402527|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402528|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402529|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402530|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402531|NCT00615017|O6|Outcome|Placebo|Placebo
402532|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402533|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402534|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402535|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402536|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402537|NCT00615017|O6|Outcome|Placebo|Placebo
402538|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402539|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402540|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402541|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402542|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402543|NCT00615017|O6|Outcome|Placebo|Placebo
402544|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402545|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402546|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402547|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402548|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402549|NCT00615017|O6|Outcome|Placebo|Placebo
402550|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402551|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402552|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402553|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402554|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402555|NCT00615017|O6|Outcome|Placebo|Placebo
402556|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402557|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402558|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402559|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402560|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402561|NCT00615017|O6|Outcome|Placebo|Placebo
402562|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402563|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402564|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402565|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402566|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402567|NCT00615017|O6|Outcome|Placebo|Placebo
410207|NCT00594464|O2|Outcome|Rotigotine 6mg/24h|
402568|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402569|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402570|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402571|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402572|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402573|NCT00615017|O6|Outcome|Placebo|Placebo
402574|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402575|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402576|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402577|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402578|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402579|NCT00615017|O6|Outcome|Placebo|Placebo
402580|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402581|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402582|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402583|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402584|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402585|NCT00615017|O6|Outcome|Placebo|Placebo
402586|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402587|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402588|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402589|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402590|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402591|NCT00615017|O6|Outcome|Placebo|Placebo
402592|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402593|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402594|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402595|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402596|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402597|NCT00615017|O6|Outcome|Placebo|Placebo
402598|NCT00615017|O5|Outcome|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402599|NCT00615017|O4|Outcome|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402600|NCT00615017|O3|Outcome|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402601|NCT00615017|O2|Outcome|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402602|NCT00615017|O1|Outcome|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402603|NCT00615017|E6|Reported Event|Placebo|Placebo
402604|NCT00615017|E5|Reported Event|AZD9773 Cohort 5 (750/250 Units/kg)|AZD9773: loading infusion of 750 units/kg then 9 maintenance doses of 250 units/kg q12hrs
402605|NCT00615017|E4|Reported Event|AZD9773 Cohort 4 (500/100 Units/kg)|AZD9773: loading infusion of 500 units/kg then 9 maintenance doses of 100 units/kg q12hrs
402606|NCT00615017|E3|Reported Event|AZD9773 Cohort 3 (250/50 Units/kg)|AZD9773: loading infusion of 250 units/kg then 9 maintenance doses of 50 units/kg q12hrs
402607|NCT00615017|E2|Reported Event|AZD9773 Cohort 2 (250 Units/kg)|AZD9773: single infusion of 250 units/kg
402608|NCT00615017|E1|Reported Event|AZD9773 Cohort 1 (50 Units/kg)|AZD9773: single infusion of 50 units/kg
402609|NCT00614991|B7|Baseline|Total|Total of all reporting groups
402610|NCT00614991|B6|Baseline|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
402611|NCT00614991|B5|Baseline|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
402612|NCT00614991|B4|Baseline|Group D|Period 1-Raltegravir 400mg BID Period 2- Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
402613|NCT00614991|B3|Baseline|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
402614|NCT00614991|B2|Baseline|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
402615|NCT00614991|B1|Baseline|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
402616|NCT00614991|P6|Participant Flow|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
402617|NCT00614991|P5|Participant Flow|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg once daily (QD) + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
402618|NCT00614991|P4|Participant Flow|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID
402619|NCT00614991|P3|Participant Flow|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
402620|NCT00614991|P2|Participant Flow|Group B|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
402621|NCT00614991|P1|Participant Flow|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
402622|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402623|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
402624|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
402625|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402626|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
402627|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
402628|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402629|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID"
402630|NCT00614991|O1|Outcome|Group A & B|Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Group B Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
402631|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402632|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
402633|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
402634|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402635|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
402636|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
402637|NCT00614991|O6|Outcome|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
402638|NCT00614991|O5|Outcome|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
402639|NCT00614991|O4|Outcome|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
402640|NCT00614991|O3|Outcome|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
402641|NCT00614991|O2|Outcome|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
402642|NCT00614991|O1|Outcome|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
402643|NCT00614991|O3|Outcome|Group E & F|"Group E Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID~Group F Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD"
402644|NCT00614991|O2|Outcome|Group C & D|"Group C Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID~Group D Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID"
402645|NCT00614991|O1|Outcome|Group A & B|"Group A Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID~Group B Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID"
402646|NCT00614991|E6|Reported Event|Group F|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD
402647|NCT00614991|E5|Reported Event|Group E|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg QD + Ritonavir 100mg QD Period 3-Fosamprenavir 1400mg QD + Ritonavir 100mg QD + Raltegravir 400mg BID
402648|NCT00614991|E4|Reported Event|Group D|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 700mg BID + Raltegravir 100mg BID
402649|NCT00614991|E3|Reported Event|Group C|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 700mg BID + Ritonavir 100mg BID Period 3-Fosamprenavir 700mg BID + Ritonavir 100mg BID + Raltegravir 400mg BID
402650|NCT00614991|E2|Reported Event|Group B|Period 1-Raltegravir 400mg BID Period2-Fosamprenavir 1400mg BID + Raltegravir 400mg BID Period 3-Fosamprenavir 1400mg BID
402651|NCT00614991|E1|Reported Event|Group A|Period 1-Raltegravir 400mg BID Period 2-Fosamprenavir 1400mg BID Period 3-Fosamprenavir 1400mg BID + Raltegravir 400mg BID
402652|NCT00614939|B3|Baseline|Total|Total of all reporting groups
402653|NCT00614939|B2|Baseline|Saxa|Saxagliptin 2.5 mg once daily oral dose
402654|NCT00614939|B1|Baseline|Placebo|Placebo
402655|NCT00614939|P2|Participant Flow|Saxa|Saxagliptin 2.5 mg once daily oral dose
402656|NCT00614939|P1|Participant Flow|Placebo|Placebo
402657|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402658|NCT00614939|O1|Outcome|Placebo|Placebo
402659|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402660|NCT00614939|O1|Outcome|Placebo|Placebo
402661|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402662|NCT00614939|O1|Outcome|Placebo|Placebo
402663|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402664|NCT00614939|O1|Outcome|Placebo|Placebo
402665|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402666|NCT00614939|O1|Outcome|Placebo|Placebo
402667|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402668|NCT00614939|O1|Outcome|Placebo|Placebo
402669|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402670|NCT00614939|O1|Outcome|Placebo|Placebo
402671|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402672|NCT00614939|O1|Outcome|Placebo|Placebo
402673|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402674|NCT00614939|O1|Outcome|Placebo|Placebo
402675|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402676|NCT00614939|O1|Outcome|Placebo|Placebo
402677|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402678|NCT00614939|O1|Outcome|Placebo|Placebo
402679|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402680|NCT00614939|O1|Outcome|Placebo|Placebo
402681|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402682|NCT00614939|O1|Outcome|Placebo|Placebo
402683|NCT00614939|O2|Outcome|Saxa|Saxagliptin 2.5 mg once daily oral dose
402684|NCT00614939|O1|Outcome|Placebo|Placebo
402685|NCT00614939|E2|Reported Event|Saxa|Saxagliptin 2.5 mg once daily oral dose
402686|NCT00614939|E1|Reported Event|Placebo|Placebo
402687|NCT00614926|B3|Baseline|Total|Total of all reporting groups
402688|NCT00614926|B2|Baseline|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
402689|NCT00614926|B1|Baseline|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
402690|NCT00614926|P2|Participant Flow|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
402691|NCT00614926|P1|Participant Flow|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
402692|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
402693|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
402694|NCT00614926|O2|Outcome|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
410208|NCT00594464|O1|Outcome|Rotigotine 2 mg/24h|
402695|NCT00614926|O1|Outcome|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
402696|NCT00614926|E2|Reported Event|Placebo|Placebo capsules are administered on the same schedule as active drug: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day in the absence of clinical improvement and dose limiting side effects. Dose is daily, in A.M.
402697|NCT00614926|E1|Reported Event|Modafinil|Dose schedule: 50 mg/day for 1 week, increasing to 100 mg/day at Week 2. Thereafter, dose may be increased to 300 mg/day as clinically indicated, in the absence of dose-limiting side effects. Dose is daily, in A.M., for 4 weeks.
402698|NCT00614913|B1|Baseline|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
402699|NCT00614913|P1|Participant Flow|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
402700|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
402701|NCT00614913|O1|Outcome|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
402702|NCT00614913|E1|Reported Event|Proton Beam Therapy|Patients received 63Gy in three weeks with proton beam.
402703|NCT00614874|B1|Baseline|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402704|NCT00614874|P1|Participant Flow|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402705|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402706|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402707|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402708|NCT00614874|O1|Outcome|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402709|NCT00614874|E1|Reported Event|Rosiglitazone|Subjects will take rosiglitazone 2 mg for 4 weeks, then 4mg for 4 weeks, then 8 mg for 4 weeks
402710|NCT00614614|B3|Baseline|Total|Total of all reporting groups
402711|NCT00614614|B2|Baseline|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402712|NCT00614614|B1|Baseline|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
402713|NCT00614614|P5|Participant Flow|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402714|NCT00614614|P4|Participant Flow|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402715|NCT00614614|P3|Participant Flow|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402716|NCT00614614|P2|Participant Flow|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402717|NCT00614614|P1|Participant Flow|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during the Primary Vaccination Phase. For the Booster Vaccination Phase, subjects were re-randomized and received either 1 dose of Nimenrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 1 Group] or a fourth dose of Menhibrix vaccine (at 12-15 months of age) and 1 dose of Infanrix vaccine (at 15-18 months of age) [Menhibrix 2 Group], or 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine (at 15-18 months of age) [Nimenrix 2 Group].
402718|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402719|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402720|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402721|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402722|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402723|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402724|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402725|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402726|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402727|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402728|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402975|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
410316|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
402729|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402730|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402731|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402732|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402733|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402734|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402735|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402736|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402737|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402738|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402739|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
402740|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
402741|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
402742|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402743|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402744|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402745|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age.during Booster Vaccination Phase.
402746|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402747|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402748|NCT00614614|O2|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402749|NCT00614614|O1|Outcome|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
402750|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402751|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402752|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402753|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402754|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402755|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402756|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402757|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402758|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402759|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402760|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402761|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402762|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402763|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402764|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402765|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402766|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402767|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402768|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402769|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402770|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402771|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402772|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402773|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402774|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402775|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402776|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402777|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402778|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402779|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402780|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402781|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402782|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402783|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402784|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402785|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402786|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402787|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402788|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402789|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402790|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402791|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402792|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402793|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402794|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402795|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402796|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402797|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402798|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402799|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402800|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402801|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402802|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402803|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402804|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402805|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402806|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402807|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402808|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402809|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402810|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402811|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402812|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402813|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402814|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402815|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402816|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402817|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402818|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402819|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402820|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402821|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402822|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402823|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402824|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402825|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402826|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402827|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402828|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402829|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402830|NCT00614614|O4|Outcome|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402831|NCT00614614|O3|Outcome|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402832|NCT00614614|O2|Outcome|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402833|NCT00614614|O1|Outcome|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402834|NCT00614614|E5|Reported Event|Nimenrix 2 Group|Subjects received 1 dose of Nimenrix vaccine co-administered with 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402835|NCT00614614|E4|Reported Event|Menhibrix 2 Group|Subjects received a fourth dose of Menhibrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402836|NCT00614614|E3|Reported Event|Nimenrix 1 Group|Subjects received 1 dose of Nimenrix vaccine at 12-15 months of age and 1 dose of Infanrix vaccine at 15-18 months of age during Booster Vaccination Phase.
402837|NCT00614614|E2|Reported Event|ActHIB- Infanrix Group|Subjects received 3 doses of ActHIB vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age at Primary Vaccination Phase and 1 booster dose of Infanrix vaccine at 15-18 months of age at Booster Vaccination Phase.
402838|NCT00614614|E1|Reported Event|Menhibrix 1 Group|Subjects received 3 doses of Menhibrix vaccine and 3 doses of Pediarix vaccine at 2, 4 and 6 months of age during Primary Vaccination Phase.
402839|NCT00614575|B1|Baseline|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402840|NCT00614575|P1|Participant Flow|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402841|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402842|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402857|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402843|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402844|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402845|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402846|NCT00614575|O1|Outcome|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402847|NCT00614575|E1|Reported Event|BI-Sifrol Tablets|According to the dosage and administration described in the package insert of the drug in Japan, the drug was administered orally to PD patients with depressive symptoms under condition of routine medical practice. The description is as follows; Usually in adults, the starting dosage of pramipexole hydrochloride hydrate is 0.25 mg/day, followed by 0.5 mg/day during Week 2 of treatment, and the dosage is then increased by 0.5 mg/day each week under close observation to determine the maintenance dose (standard daily dose, 1.5-4.5 mg). When the daily dose of pramipexole hydrochloride hydrate is less than 1.5 mg, the daily dose will be divided into two doses to be taken after breakfast and after dinner. When the daily dose is 1.5 mg or higher, the daily dose will be divided into three doses to be taken after every meal. The dosage may be adjusted according to age and symptoms of the patient, but the daily dose should not exceed 4.5 mg.
402848|NCT00614523|B3|Baseline|Total|Total of all reporting groups
402849|NCT00614523|B2|Baseline|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402850|NCT00614523|B1|Baseline|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402851|NCT00614523|P2|Participant Flow|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402852|NCT00614523|P1|Participant Flow|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402853|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402854|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402855|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402856|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402969|NCT00614380|O1|Outcome|Pre-antihypertensive: Yes (DBP<90 mmHg)|
402970|NCT00614380|O1|Outcome|Total|
410317|NCT00594425|O3|Outcome|Vehicle PDT|
402858|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402859|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402860|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402861|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402862|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402863|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402864|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402865|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402866|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402867|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402868|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402869|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402870|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402871|NCT00614523|O2|Outcome|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402872|NCT00614523|O1|Outcome|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402873|NCT00614523|E2|Reported Event|Romiplostim|Weekly subcutaneous dosing based on platelet count for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period. Starting dose is at 750 μg, up to a maximum dose of 1000 μg, or reduced to a minimum of 250 μg.
402874|NCT00614523|E1|Reported Event|Placebo|Weekly subcutaneous dosing with blinded matching placebo dose level for 26 weeks during the Test Treatment Period and for 24 weeks during the Extended Treatment Period, separated by a 4-week interim washout period.
402875|NCT00614484|B1|Baseline|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
402876|NCT00614484|P1|Participant Flow|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
402877|NCT00614484|O1|Outcome|Chemotherapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
402878|NCT00614484|O1|Outcome|Chemothrapy and Proton Therapy|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
402879|NCT00614484|E1|Reported Event|Treatment With Chemotherapy and Proton Beam Radiotherapy.|Induction chemotherapy with two cycles of taxol and carboplatin given on day 1 and day 15. A five week coarse of proton radiotherapy begins on day 28 and is given once daily for the first two weeks and twice daily for the final 3 weeks. Weekly chemotherapy with carboplatin and taxol is given during proton therapy.
402880|NCT00614458|B1|Baseline|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
410318|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
402881|NCT00614458|P1|Participant Flow|Effect on Latent HIV of Adding Raltegravir and VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and Valproic acid (VPA) and current antiretroviral therapy (ART) on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
402882|NCT00614458|O1|Outcome|Effect on Latent HIV of Adding Raltegravir and VPA to ART|
402883|NCT00614458|E1|Reported Event|Effect on Latent HIV of Adding Raltegravir and/or VPA to ART|Single arm pilot study that measured the effect of adding Raltegravir and/or VPA and current ART on the persistence of latent HIV infection within circulating, resting CD4+ T cells in patients stably suppressed by ART
402884|NCT00614445|B3|Baseline|Total|Total of all reporting groups
402885|NCT00614445|B2|Baseline|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
402886|NCT00614445|B1|Baseline|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
402887|NCT00614445|P2|Participant Flow|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
402888|NCT00614445|P1|Participant Flow|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
402889|NCT00614445|O2|Outcome|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
402890|NCT00614445|O1|Outcome|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
402891|NCT00614445|E2|Reported Event|Placebo|Placebo tablets identical in size, shape, taste, and color to the experimental treatment (Diclectin®)
402892|NCT00614445|E1|Reported Event|Diclectin®|Diclectin® (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) delayed release tablet
402893|NCT00614406|B3|Baseline|Total|Total of all reporting groups
402894|NCT00614406|B2|Baseline|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
402895|NCT00614406|B1|Baseline|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
402896|NCT00614406|P2|Participant Flow|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
402897|NCT00614406|P1|Participant Flow|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
402898|NCT00614406|O2|Outcome|Placebo|Placebo cycle orally, daily x1 menstrual cycle [cycle = length of menstrual cycle]
402899|NCT00614406|O1|Outcome|Active Drug|Active drug(celecoxib 400 mg orally, daily for 1 menstrual cycle) cycle [cycle = length of menstrual cycle]
402900|NCT00614406|E2|Reported Event|Placebo|Group 2: control cycle, celecoxib cycle, placebo cycle orally, daily x1 menstrual cycle
402901|NCT00614406|E1|Reported Event|Active Drug Cycle|Group 1: control cycle, placebo cycle, active drug (celecoxib 400 mg orally, daily x1 menstrual cycle) cycle
402902|NCT00614393|B6|Baseline|Total|Total of all reporting groups
402903|NCT00614393|B5|Baseline|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402904|NCT00614393|B4|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402905|NCT00614393|B3|Baseline|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402906|NCT00614393|B2|Baseline|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402907|NCT00614393|B1|Baseline|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402908|NCT00614393|P5|Participant Flow|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received a cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402909|NCT00614393|P4|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402910|NCT00614393|P3|Participant Flow|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402911|NCT00614393|P2|Participant Flow|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the open-label (OL) portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV one time every two weeks (Q2W) for up to 32 months of treatment.
402912|NCT00614393|P1|Participant Flow|Dalotuzumab 10 mg/kg Q1W (DB)|In double-blind (DB) Week 1, participants received cetuximab 400 mg/m^2 intravenously (IV) loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV one time each week (Q1W) maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402913|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402914|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402915|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402916|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402917|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402918|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402919|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402920|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402921|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402922|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402923|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402924|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402925|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402926|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402927|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402928|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402929|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402930|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402931|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402932|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402933|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402934|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402935|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402936|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402937|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402938|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402939|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402940|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402971|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402941|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402942|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402943|NCT00614393|O5|Outcome|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402944|NCT00614393|O4|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402945|NCT00614393|O3|Outcome|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402946|NCT00614393|O2|Outcome|Dalotuzumab 15 mg/kg/7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402947|NCT00614393|O1|Outcome|Dalotuzumab 10 mg/kg Q1W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402948|NCT00614393|E5|Reported Event|Placebo + Cetuximab + Irinotecan (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB normal saline (placebo) IV Q1W for up to 32 months of treatment.
402949|NCT00614393|E4|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (DB)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402950|NCT00614393|E3|Reported Event|Dalotuzumab 10 mg/kg Q1W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W+ irinotecan Q1W at their pre-study dosage + OL dalotuzumab 10 mg/kg IV Q1W to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402951|NCT00614393|E2|Reported Event|Dalotuzumab 15 mg/kg /7.5 mg/kg Q2W (OL)|In the OL portion of the study, ≥6 participants received cetuximab 400 mg/m^2 Q1W + irinotecan Q1W at their pre-study dosage + OL dalotuzumab (loading dose of 15 mg/kg IV followed by a maintenance dose of 7.5 mg/kg 2 weeks later) to verify the safety of the regimen. In DB Week 1, participants received cetuximab 400 mg/m^2 IV + irinotecan IV. In DB Week 2, participants received cetuximab 250 mg/m^2 IV + irinotecan IV + DB dalotuzumab 15 mg/kg IV. In DB Week 3, participants received cetuximab 250 mg/m^2 IV + irinotecan IV. Starting with DB Week 4, participants received cetuximab 250 mg/m^2 IV Q1W + irinotecan IV Q1W + DB dalotuzumab 7.5 mg/kg IV Q2W for up to 32 months of treatment.
402952|NCT00614393|E1|Reported Event|Dalotuzumab 10 mg/kg Q1W (BD)|In DB Week 1, participants received cetuximab 400 mg/m^2 IV loading dose and irinotecan IV at their pre-study dosage. Starting with DB Week 2, participants received cetuximab 250 mg/m^2 IV Q1W maintenance dose, irinotecan IV Q1W and DB dalotuzumab 10 mg/kg IV Q1W for up to 32 months of treatment.
402953|NCT00614380|B5|Baseline|Total|Total of all reporting groups
402954|NCT00614380|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402955|NCT00614380|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402956|NCT00614380|B2|Baseline|Telmisartan 80mg and Amlodipine 5mg|
402957|NCT00614380|B1|Baseline|Telmisartan 40mg and Amlodipine 5mg|
402958|NCT00614380|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402959|NCT00614380|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402960|NCT00614380|P2|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
402961|NCT00614380|P1|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
402962|NCT00614380|O3|Outcome|Pre-titration: Total|
402963|NCT00614380|O2|Outcome|Pre-titration: No (DBP>=90 mmHg)|
402964|NCT00614380|O1|Outcome|Pre-titration: Yes (DBP<90 mmHg)|
402965|NCT00614380|O1|Outcome|Total|
402966|NCT00614380|O1|Outcome|Total|
402967|NCT00614380|O3|Outcome|Pre-antihypertensive: Total|
402968|NCT00614380|O2|Outcome|Pre-antihypertensive: No (DBP>=90 mmHg)|
402976|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402977|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402978|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402979|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402980|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402981|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402982|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402983|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402984|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402985|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402986|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402987|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402988|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402989|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402990|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402991|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402992|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402993|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402994|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402995|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
402996|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
402997|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
402998|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
402999|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
403000|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
403001|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
403002|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
403003|NCT00614380|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg + add-on Antihypertensive|
403004|NCT00614380|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg + add-on Antihypertensive|
403005|NCT00614380|O2|Outcome|Telmisartan 80mg and Amlodipine 5mg|
403006|NCT00614380|O1|Outcome|Telmisartan 40mg and Amlodipine 5mg|
403007|NCT00614380|E2|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
403008|NCT00614380|E1|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
403009|NCT00614315|B1|Baseline|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
403010|NCT00614315|P1|Participant Flow|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
403011|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
403012|NCT00614315|O1|Outcome|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
403013|NCT00614315|E1|Reported Event|FLAIR Endovascular Stent Graft|Patients treated with the FLAIR Endovascular Stent Graft
403014|NCT00613938|B5|Baseline|Total|Total of all reporting groups
403015|NCT00613938|B4|Baseline|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403016|NCT00613938|B3|Baseline|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403017|NCT00613938|B2|Baseline|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403018|NCT00613938|B1|Baseline|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403019|NCT00613938|P4|Participant Flow|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403020|NCT00613938|P3|Participant Flow|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403021|NCT00613938|P2|Participant Flow|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403022|NCT00613938|P1|Participant Flow|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403023|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403024|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403025|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403026|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403027|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403028|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403029|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403030|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403031|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403032|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403033|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403034|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403035|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403036|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403037|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403038|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403039|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403040|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403041|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403042|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403043|NCT00613938|O4|Outcome|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403044|NCT00613938|O3|Outcome|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403045|NCT00613938|O2|Outcome|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403046|NCT00613938|O1|Outcome|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403047|NCT00613938|E4|Reported Event|Oxycodone 10mg Fixed Dose|Oxycodone 10mg capsule taken by mouth every 4 to 6 hours for 3 days.
403048|NCT00613938|E3|Reported Event|Tapentadol 75mg Fixed Dose|Tapentadol 75mg capsule taken by mouth every 4 to 6 hours for 3 days.
403049|NCT00613938|E2|Reported Event|Tapentadol 50mg Fixed Dose|Tapentadol 50mg capsule taken by mouth every 4 to 6 hours for 3 days.
403050|NCT00613938|E1|Reported Event|Placebo|Placebo capsule taken by mouth every 4 to 6 hours for 3 days.
403051|NCT00613925|B3|Baseline|Total|Total of all reporting groups
403052|NCT00613925|B2|Baseline|Explora Group|Women were randomized to the Explora device for endometrial biopsy
403053|NCT00613925|B1|Baseline|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
403054|NCT00613925|P2|Participant Flow|Explora Group|Women were randomized to the Explora device for endometrial biopsy
403055|NCT00613925|P1|Participant Flow|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
403056|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
403057|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
403058|NCT00613925|O2|Outcome|Explora Group|Women were randomized to the Explora device for endometrial biopsy
403059|NCT00613925|O1|Outcome|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
403060|NCT00613925|E2|Reported Event|Explora Group|Women were randomized to the Explora device for endometrial biopsy
403061|NCT00613925|E1|Reported Event|Pipelle Group|Women were randomized to the Pipelle for endometrial biopsy
403062|NCT00613730|B1|Baseline|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403063|NCT00613730|P1|Participant Flow|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403064|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403065|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403066|NCT00613730|O1|Outcome|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403067|NCT00613730|E1|Reported Event|Gemcitabine + Panitumumab|Panitumumab 6 mg/kg was administered intravenously (IV) before gemcitabine on Day 1 of Weeks 1, 3, 5, and 7, and then every 2 weeks (day 1 and 15) of each subsequent 4-week chemotherapy cycle. Gemcitabine 1000 mg/m^2 was administered IV once weekly (on Day 1) for 7 weeks, followed by a 1-week rest period. In subsequent cycles, gemcitabine was given once weekly (on Day 1) for 3 consecutive weeks followed by 1 week of rest. Panitumumab and gemcitabine treatment continued until disease progression, unacceptable adverse events, death, or study withdrawal occurred.
403068|NCT00613626|B4|Baseline|Total|Total of all reporting groups
403081|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403138|NCT00613379|P2|Participant Flow|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
403139|NCT00613379|P1|Participant Flow|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
403140|NCT00613379|O3|Outcome|Arm 3|PBO, one IV dose (N=10)
403069|NCT00613626|B3|Baseline|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403070|NCT00613626|B2|Baseline|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403071|NCT00613626|B1|Baseline|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403072|NCT00613626|P3|Participant Flow|Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator. The safety lead-in will be conducted to determine the safety of the combination of ZD6474 and cisplation + etopiside. If this combination is found to be unsafe, no patients will be randomized in the Phase II portion of the trial. If the combination is deemed safe according to the protocol, participants from the safety lead-in cohort will not be included in the efficacy analysis.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403073|NCT00613626|P2|Participant Flow|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403074|NCT00613626|P1|Participant Flow|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403075|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403076|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403077|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403078|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403079|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403080|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403082|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403083|NCT00613626|O2|Outcome|Arm B: ZD6474 + Safety Lead-In|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403084|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403085|NCT00613626|O2|Outcome|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403086|NCT00613626|O1|Outcome|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403087|NCT00613626|E2|Reported Event|Arm B: ZD6474|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 100mg oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~ZD6474: ZD6474 100mg oral daily to be continued for the duration of the study."
403088|NCT00613626|E1|Reported Event|Arm A: ZD6474 Matched Placebo|"Subjects will receive cisplatin 60 mg/m2 IV day 1 plus etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles plus ZD6474 matched placebo oral daily to be continued for the duration of the study. Prophylactic antiemetics will be given at the discretion of the treating investigator.~Cisplatin: Cisplatin 60 mg/m2 IV day 1 every 21 days for a total of 4 cycles~Etoposide: Etoposide 120 mg/m2 IV days 1, 2, and 3 every 21 days for a total of 4 cycles~Placebo: Matched placebo oral daily"
403089|NCT00613574|B1|Baseline|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403090|NCT00613574|P1|Participant Flow|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403091|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403092|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403093|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403094|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403095|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403096|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403097|NCT00613574|O1|Outcome|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403098|NCT00613574|E1|Reported Event|Spiriva® (Tiotropium Bromide)|Tiotropium bromide 18µg inhalation capsules once-daily
403099|NCT00613509|B3|Baseline|Total|Total of all reporting groups
403100|NCT00613509|B2|Baseline|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403101|NCT00613509|B1|Baseline|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403102|NCT00613509|P2|Participant Flow|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403103|NCT00613509|P1|Participant Flow|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403104|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403105|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403106|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403134|NCT00613379|B3|Baseline|Arm 3|PBO, one IV dose (N=10)
403107|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403108|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403109|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403110|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403111|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403112|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403113|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403114|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403115|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403116|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403117|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403118|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403119|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403120|NCT00613509|O2|Outcome|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403121|NCT00613509|O1|Outcome|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403122|NCT00613509|E2|Reported Event|Study Group 2: Interferon Alpha-2b|Participants on Four weeks of high-dose IFN-α2b. (Participants that showed disease progression after Cycle 1 were permitted to cross over to Group 1 treatment)
403123|NCT00613509|E1|Reported Event|Study Group 1: ALVAC Melanoma Vaccine|Participants received vaccine treatment consisting of 3 series of multi-antigen ALVAC-based melanoma vaccine and GM-CSF injections, followed by four weeks of high-dose IFN-α2b. (Participants that did not show disease progression were allowed a second cycle of treatment)
403124|NCT00613405|B3|Baseline|Total|Total of all reporting groups
403125|NCT00613405|B2|Baseline|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403126|NCT00613405|B1|Baseline|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403127|NCT00613405|P2|Participant Flow|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403128|NCT00613405|P1|Participant Flow|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403129|NCT00613405|O2|Outcome|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403130|NCT00613405|O1|Outcome|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403131|NCT00613405|E2|Reported Event|No Stress|Participants assigned to this group are required to read magazines for ten minutes. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403132|NCT00613405|E1|Reported Event|Stress|Participants assigned to this group are required to complete the Trier Social Stress Task, which involves delivering a 5-minute speech and performing a 5-minute math problem in front of an audience. They then complete a cue exposure session involving both neutral and marijuana-related cues.
403133|NCT00613379|B4|Baseline|Total|Total of all reporting groups
403144|NCT00613379|E2|Reported Event|Arm 2|5 mg/kg PRO 140, one IV dose (N=10)
403145|NCT00613379|E1|Reported Event|Arm 1|10 mg/kg PRO 140, one IV dose (N=10)
403146|NCT00613366|B3|Baseline|Total|Total of all reporting groups
403147|NCT00613366|B2|Baseline|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
403148|NCT00613366|B1|Baseline|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
403149|NCT00613366|P2|Participant Flow|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
403150|NCT00613366|P1|Participant Flow|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
403151|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
403152|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
403153|NCT00613366|O2|Outcome|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
403154|NCT00613366|O1|Outcome|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
403155|NCT00613366|E2|Reported Event|Placebo|Placebo buccal 90 minutes prior to IUD insertion.
403156|NCT00613366|E1|Reported Event|Active Drug (Misoprostol)|400mcg of buccal misoprostol 90 minutes prior to IUD insertion
403157|NCT00613327|B1|Baseline|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403158|NCT00613327|P1|Participant Flow|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403159|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403160|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403161|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403162|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403163|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403164|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403165|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403166|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403167|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403168|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403169|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403170|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403288|NCT00612677|B1|Baseline|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403289|NCT00612677|P1|Participant Flow|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403171|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403172|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403173|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403174|NCT00613327|O1|Outcome|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403175|NCT00613327|E1|Reported Event|Oxybutynin Chloride OROS|Oxybutynin chloride osmotic release oral system (OROS) tablet at starting dose of 10 milligram (mg) orally once daily. The dose was adjusted by 10 mg every 2 weeks up to first 6 weeks, based on the criteria for evaluation of optimal dose. The optimal dose obtained in first 6 weeks was continued up to Week 12. Maximum allowed dose was 30 mg per day.
403176|NCT00613314|B1|Baseline|Telmisartan (Micardis)|
403177|NCT00613314|P1|Participant Flow|Telmisartan (Micardis)|
403178|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
403179|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
403180|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
403181|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
403182|NCT00613314|O1|Outcome|Telmisartan (Micardis)|
403183|NCT00613314|E1|Reported Event|Telmisartan (Micardis)|
403184|NCT00613301|B1|Baseline|Pramipexole|The number of patients enrolled was 416. The number of case report form which were collected was 364. Moreover the number of patients analyzed as safety analysis was 346 because 18 patients were excluded due to protocol violations.
403185|NCT00613301|P1|Participant Flow|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
403186|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
403187|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
403188|NCT00613301|O1|Outcome|Pramipexole|BI-Sifrol® Tablets dose: 0.125 mg, 0.5 mg mode of administration: oral
403189|NCT00613301|O1|Outcome|Pramipexole|Substance (INN): Pramipexole Trade name: BI-Sifrol® Pharmaceutical form: Tablet Source: Marketed products (There was no investigational products in this PMS) Unit strength: 0.125 mg and 0.5 mg Daily dose: Approved dose range (From 0.25 mg/day to 4.5 mg/day) Duration of use: 3 years Route of administration: Orally
403190|NCT00613301|E1|Reported Event|Pramipexole|The drug was administered orally to patients according to the package insert in Japan. The drug form is only tablet. The initial dose was 0.125 mg twice a day, and was escalated in case of lack of efficacy. The maintenance dose was between 1.5 mg/day and 4.5 mg/day (0.5 mg - 1.5 mg three times a day).
403191|NCT00613106|B3|Baseline|Total|Total of all reporting groups
403192|NCT00613106|B2|Baseline|Ibuprofen|Ibuprofen 800mg
403193|NCT00613106|B1|Baseline|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
403194|NCT00613106|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg
403195|NCT00613106|P1|Participant Flow|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
403196|NCT00613106|O2|Outcome|Ibuprofen|Ibuprofen 800mg
403197|NCT00613106|O1|Outcome|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
403198|NCT00613106|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
403199|NCT00613106|E1|Reported Event|HZT-501 (Ibuprofen/Famotidine)|HZT-501: ibuprofen 800mg/famotidine 26.6mg
403200|NCT00613080|B1|Baseline|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
403201|NCT00613080|P1|Participant Flow|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
403202|NCT00613080|O1|Outcome|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
403203|NCT00613080|E1|Reported Event|IMRT + Chemotherapy , Resection, Postoperative Chemotherapy|Radiation therapy (intensity modulated radiation therapy [IMRT] + three dimensional conformal radiation therapy [3D-CRT]) + neoadjuvant chemotherapy (capecitabine and oxaliplatin) followed by resection and postoperative chemotherapy (FOLFOX)
403204|NCT00613028|B3|Baseline|Total|Total of all reporting groups
403205|NCT00613028|B2|Baseline|Etoposide Arm|Pts treated w Bev + Etoposide
403206|NCT00613028|B1|Baseline|Temozolomide Arm|Pts treated w Bev + Temozolomide
403207|NCT00613028|P2|Participant Flow|Etoposide Arm|Bevacizumab + Etoposide: Patients who progressed or had grade 3 or greater toxicity related to prior daily temozolomide dosing, but have not had prior progression or grade 3 or greater toxicity related to prior daily etoposide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Etoposide will be administered once daily at 50 mg/m^2/day for the first 21 days of each 28-day cycle.
403838|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
403208|NCT00613028|P1|Participant Flow|Temozolomide Arm|Bevacizumab + Temozolomide: Patients who progressed or had grade 3 or greater toxicity related to prior daily etoposide dosing, but have not had prior progression or grade 3 toxicity related to prior daily temozolomide therapy. Patients who have not had prior progression or grade 3 or greater toxicity with either daily temozolomide or etoposide or who have no prior exposure to either will be randomized to one of the groups. Bevacizumab will be administered intravenously at 10mg/kg every other week. Temozolomide will be administered ona continuous daily dosing schedule at 50 mg/m^2/day.
403209|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
403210|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
403211|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
403212|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
403213|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
403214|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
403215|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
403216|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
403217|NCT00613028|O2|Outcome|Etoposide Arm|Pts treated w Bev + Etoposide
403218|NCT00613028|O1|Outcome|Temozolomide Arm|Pts treated w Bev + Temozolomide
403219|NCT00613028|E2|Reported Event|Etoposide Arm|Pts treated w Bev + Etoposide
403220|NCT00613028|E1|Reported Event|Temozolomide Arm|Pts treated w Bev + Temozolomide
403221|NCT00613015|B7|Baseline|Total|Total of all reporting groups
403222|NCT00613015|B6|Baseline|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
403223|NCT00613015|B5|Baseline|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
403224|NCT00613015|B4|Baseline|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
403225|NCT00613015|B3|Baseline|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
403226|NCT00613015|B2|Baseline|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
403227|NCT00613015|B1|Baseline|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
403228|NCT00613015|P6|Participant Flow|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
403229|NCT00613015|P5|Participant Flow|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
403230|NCT00613015|P4|Participant Flow|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
403231|NCT00613015|P3|Participant Flow|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
403232|NCT00613015|P2|Participant Flow|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
403233|NCT00613015|P1|Participant Flow|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
403234|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
403235|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
403236|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
403237|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
403238|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
403239|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
403240|NCT00613015|O6|Outcome|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
403241|NCT00613015|O5|Outcome|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
403242|NCT00613015|O4|Outcome|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
403243|NCT00613015|O3|Outcome|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
403244|NCT00613015|O2|Outcome|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
403245|NCT00613015|O1|Outcome|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
403246|NCT00613015|E6|Reported Event|Placebo/No Stress|Participants received placebo for 3 days and did not complete the TRIER social stress task on the third day.
403247|NCT00613015|E5|Reported Event|Placebo/Stress|Participants received placebo for 3 days and completed the TRIER social stress task on the third day.
403248|NCT00613015|E4|Reported Event|Guanfacine/No Stress|Participants received placebo for 2 days, guanfacine for 1 day, and did not complete the TRIER social stress task on the third day.
403249|NCT00613015|E3|Reported Event|Guanfacine/Stress|Participants received placebo for 2 days, guanfacine for 1 day, and completed the TRIER social stress task on the third day.
403250|NCT00613015|E2|Reported Event|Modafinil/No Stress|Participants received modafinil for 3 days and did not complete the TRIER social stress task on the third day.
403251|NCT00613015|E1|Reported Event|Modafinil/Stress|Participants received Modafinil for three days and completed a TRIER social stress task on the third day.
403252|NCT00612924|B3|Baseline|Total|Total of all reporting groups
403253|NCT00612924|B2|Baseline|ONE-LOK|
410319|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
403254|NCT00612924|B1|Baseline|Anaconda|The original protocol identified that the Anaconda™ Stent Graft System would be used throughout the current Phase II study. However, a modified device design became available during the course of the current Phase II study and is called the ONELOK™ Stent Graft System. As the modifications to the device design are considered minor, there are no expected differences in the anticipated safety or effectiveness of the device. The design changes relate primary to a uni-docking zone in the bifurcate body to maximize sizing compatibilities between the bifurcate body and the iliac limbs.
403255|NCT00612924|P2|Participant Flow|ONE-LOK|
403256|NCT00612924|P1|Participant Flow|Anaconda|
403257|NCT00612924|O2|Outcome|ONE LOK|
403258|NCT00612924|O1|Outcome|Anaconda|
403259|NCT00612924|O3|Outcome|Total|
403260|NCT00612924|O2|Outcome|ONE LOK|
403261|NCT00612924|O1|Outcome|Anaconda|
403262|NCT00612924|O2|Outcome|ONE LOK|
403263|NCT00612924|O1|Outcome|Anaconda|
403264|NCT00612924|E2|Reported Event|ONE-LOK|
403265|NCT00612924|E1|Reported Event|Anaconda|
403266|NCT00612807|B3|Baseline|Total|Total of all reporting groups
403267|NCT00612807|B2|Baseline|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
403268|NCT00612807|B1|Baseline|Semi-weekly Medication Management|Medication management with a study doctor every other week.
403269|NCT00612807|P2|Participant Flow|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
403270|NCT00612807|P1|Participant Flow|Semi-weekly Medication Management|Medication management with a study doctor every other week.
403271|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
403272|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
403273|NCT00612807|O2|Outcome|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
403274|NCT00612807|O1|Outcome|Semi-weekly Medication Management|Medication management with a study doctor every other week.
403275|NCT00612807|E2|Reported Event|Semi-weekly Medication Management + Weekly Marital Therapy|Medication management with a study doctor every other week plus weekly marital therapy.
403276|NCT00612807|E1|Reported Event|Semi-weekly Medication Management|Medication management with a study doctor every other week.
403277|NCT00612690|B3|Baseline|Total|Total of all reporting groups
403278|NCT00612690|B2|Baseline|Services As Usual|Referral to nearby community mental heath agencies for clinic-based services where participants received standard care for mental health-related problems.
403279|NCT00612690|B1|Baseline|Links to Learning|Mental health intervention focused on enhancing the predictors of young children's school success
403280|NCT00612690|P2|Participant Flow|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
403281|NCT00612690|P1|Participant Flow|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
403282|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services, where participants received standard care for mental health-related problems."
403283|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
403284|NCT00612690|O2|Outcome|Services as Usual|"Participants received treatment as usual and referrals.~Treatment as usual (TAU) : TAU included referral to community mental health clinic-based services where participants received standard care for mental health-related problems."
403285|NCT00612690|O1|Outcome|Links to Learning|"Participants underwent the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program included collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focused on the strongest teacher and parent predictors of student learning."
403286|NCT00612690|E2|Reported Event|Services as Usual|"Participants will receive treatment as usual and referrals.~Treatment as usual (TAU) : TAU includes referral to community mental health clinic-based services, where participants will receive standard care for mental health-related problems."
403287|NCT00612690|E1|Reported Event|Links to Learning|"Participants will undergo the community mental health consultation model program.~Community mental health consultation model program : The community mental health consultation model program includes collaboration among community mental health providers and (1) parent advocates to effectively maintain families in a school-based mental health program, (2) classroom teachers to enhance children's academic performance, and (3) peer-identified influential teachers to influence classroom teachers' use of behavior management strategies. This model further focuses on the strongest teacher and parent predictors of student learning."
403839|NCT00611442|E2|Reported Event|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
403290|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403291|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403292|NCT00612677|O1|Outcome|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403293|NCT00612677|E1|Reported Event|Chemotherapy|Single arm, two stage design Phase II study offered through the Moffitt Clinical Research Affiliate Network
403294|NCT00612573|B5|Baseline|Total|Total of all reporting groups
403295|NCT00612573|B4|Baseline|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403296|NCT00612573|B3|Baseline|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403297|NCT00612573|B2|Baseline|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403298|NCT00612573|B1|Baseline|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403299|NCT00612573|P4|Participant Flow|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403300|NCT00612573|P3|Participant Flow|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403301|NCT00612573|P2|Participant Flow|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403302|NCT00612573|P1|Participant Flow|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403303|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403304|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403305|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403306|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403307|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403308|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403309|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403310|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403311|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403312|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403313|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403314|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403315|NCT00612573|O4|Outcome|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403316|NCT00612573|O3|Outcome|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403317|NCT00612573|O2|Outcome|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403318|NCT00612573|O1|Outcome|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403319|NCT00612573|E4|Reported Event|Placebo Comparator|3 placebo tablets daily matching active 40 & 80 mg tablets
403320|NCT00612573|E3|Reported Event|Doxycycline 2.4 mg/kg/Day|160 mg doxycyline (2-80 mg tablets) plus 1 placebo tablet daily
403321|NCT00612573|E2|Reported Event|Doxycycline 1.2 mg/kg/Day|80 mg doxycycline (1-80 mg tablet) plus 2 placebo tablets daily
403322|NCT00612573|E1|Reported Event|Doxycycline 0.6 mg/kg/Day|40 mg doxycycline tablet plus 2 placebo tablets daily
403323|NCT00612534|B5|Baseline|Total|Total of all reporting groups
403324|NCT00612534|B4|Baseline|Placebo NanoTab|
403325|NCT00612534|B3|Baseline|Sufentanil NanoTab 15 Mcg|
403326|NCT00612534|B2|Baseline|Sufentanil NanoTab 10 Mcg|
403327|NCT00612534|B1|Baseline|Sufentanil NanoTab 5 Mcg|
403328|NCT00612534|P4|Participant Flow|Placebo NanoTab|
403329|NCT00612534|P3|Participant Flow|Sufentanil NanoTab 15 Mcg|
403330|NCT00612534|P2|Participant Flow|Sufentanil NanoTab 10 Mcg|
403331|NCT00612534|P1|Participant Flow|Sufentanil NanoTab 5 Mcg|
403332|NCT00612534|O4|Outcome|Placebo NanoTab|
403333|NCT00612534|O3|Outcome|Sufentanil NanoTab 15 Mcg|
403334|NCT00612534|O2|Outcome|Sufentanil NanoTab 10 Mcg|
403335|NCT00612534|O1|Outcome|Sufentanil NanoTab 5 Mcg|
403336|NCT00612534|E4|Reported Event|Placebo NanoTab|
403337|NCT00612534|E3|Reported Event|Sufentanil NanoTab 15 Mcg|
403338|NCT00612534|E2|Reported Event|Sufentanil NanoTab 10 Mcg|
403339|NCT00612534|E1|Reported Event|Sufentanil NanoTab 5 Mcg|
403340|NCT00612508|B3|Baseline|Total|Total of all reporting groups
403341|NCT00612508|B2|Baseline|NuvaRing|intravaginal contraception
403342|NCT00612508|B1|Baseline|Desogen|oral contraceptive
403343|NCT00612508|P2|Participant Flow|NuvaRing|intravaginal contraception
403344|NCT00612508|P1|Participant Flow|Desogen|oral contraceptive
403345|NCT00612508|O2|Outcome|Intravaginal Ring Contraceptive|nuvaring (ethinyl estradiol & desogestrel) = R (ring)
403346|NCT00612508|O1|Outcome|Oral Contraceptive|Desogen (ethinyl estradiol & desogestrel) = P (pill)
403347|NCT00612508|O2|Outcome|NuvaRing|intravaginal contraception = R (ring)
403348|NCT00612508|O1|Outcome|Desogen|oral contraceptive = P (pill)
403349|NCT00612508|E2|Reported Event|NuvaRing|intravaginal contraception
403350|NCT00612508|E1|Reported Event|Desogen|oral contraceptive
403351|NCT00612430|B3|Baseline|Total|Total of all reporting groups
403352|NCT00612430|B2|Baseline|Grade IV|
403353|NCT00612430|B1|Baseline|Grade III|
403467|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
404204|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
403354|NCT00612430|P2|Participant Flow|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
403355|NCT00612430|P1|Participant Flow|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
403356|NCT00612430|O2|Outcome|Grade IV|
403357|NCT00612430|O1|Outcome|Grade III|
403358|NCT00612430|O2|Outcome|Grade IV|
403359|NCT00612430|O1|Outcome|Grade III|
403360|NCT00612430|O2|Outcome|Grade IV|
403361|NCT00612430|O1|Outcome|Grade III|
403362|NCT00612430|O2|Outcome|Grade IV|
403363|NCT00612430|O1|Outcome|Grade III|
403364|NCT00612430|O2|Outcome|Grade IV|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
403365|NCT00612430|O1|Outcome|Grade III|Bevacizumab administered intravenously at dose 10 mg/kg every two weeks. If patient tolerates 1stbevacizumab dose, subsequent doses may be given by local oncologists under direct supervision of Duke investigators. Etoposide administered orally, once daily for 1st 21 days of each 28-day treatment cycle. Dose of Etoposide will be 50 mg/m2/day
403366|NCT00612430|E2|Reported Event|Grade IV|
403367|NCT00612430|E1|Reported Event|Grade III|
403368|NCT00612339|B1|Baseline|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
403369|NCT00612339|P1|Participant Flow|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
403370|NCT00612339|O1|Outcome|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
403371|NCT00612339|E1|Reported Event|Avastin and Temozolomide|Avastin administered at 10 mg/kg every 2 weeks beginning a minimum of 7 days after biopsy or 28 days after craniotomy. Temozolomide dosed at 200 mg/m2 daily for 5 days in a 28-day cycle.
403372|NCT00612313|B3|Baseline|Total|Total of all reporting groups
403373|NCT00612313|B2|Baseline|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants attended 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
403374|NCT00612313|B1|Baseline|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
403375|NCT00612313|P2|Participant Flow|Continued Medication Plus CBT|"n=75 Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
403376|NCT00612313|P1|Participant Flow|Continued Medication Alone|"n=69 Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
403377|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
403378|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
403379|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
403380|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
403468|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
404779|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
403381|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~Treatment was uncontrolled after week 30."
403382|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Treatment was uncontrolled after week 30."
403383|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~n=75"
403384|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~n=69"
403385|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, some participants will be assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they will learn specific skills to reduce and prevent the occurrence of residual depressive symptoms."
403386|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants will receive antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants will take 10 to 40 mg per day of fluoxetine for 30 weeks."
403387|NCT00612313|O2|Outcome|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms."
403388|NCT00612313|O1|Outcome|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks."
403389|NCT00612313|E2|Reported Event|Continued Medication Plus CBT|"Participants received antidepressant treatment with fluoxetine for 30 weeks plus relapse prevention cognitive behavioral therapy for the last 24 weeks of treatment~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~Relapse prevention cognitive behavioral therapy (CBT): After the first 6 weeks of treatment with fluoxetine, these participants were assigned to additionally receive relapse prevention CBT for the remaining 24 weeks of treatment. These participants will attend 10 to 12 CBT sessions, during which they learned specific skills to reduce and prevent the occurrence of residual depressive symptoms.~N=75"
403390|NCT00612313|E1|Reported Event|Continued Medication Alone|"Participants received antidepressant treatment with fluoxetine for 30 weeks~Fluoxetine: Participants took 10 to 40 mg per day of fluoxetine for 30 weeks.~N=69"
403391|NCT00612222|B1|Baseline|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403392|NCT00612222|P1|Participant Flow|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403393|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403394|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403469|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
404783|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
403395|NCT00612222|O1|Outcome|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403396|NCT00612222|E1|Reported Event|ALVAC Plus Anti-MART-1 F5 TCR PBL + HD IL-2|"ALVAC plus anti-MART-1 F5 T cell receptor (TCR ) peripheral blood lymphocytes (PBL) + HD IL-2: ALVAC vaccine-approximately two hours prior to cell infusion, patients will receive 0.5 mL containing a target dose of 10^7 CCID50 (with a range of approximately 10^6,4 to 10^7,9/mL) of the MART-1 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2 mL). This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenously over 15 minutes every 8 hours (+/- 1 hour) for up to 5 days."
403397|NCT00612105|B3|Baseline|Total|Total of all reporting groups
403398|NCT00612105|B2|Baseline|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403399|NCT00612105|B1|Baseline|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403400|NCT00612105|P2|Participant Flow|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403401|NCT00612105|P1|Participant Flow|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403402|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403403|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403404|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403405|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403406|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403407|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403408|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403601|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403409|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403410|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403411|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403412|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403413|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403414|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403415|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403416|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403417|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403418|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403419|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403420|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403470|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403471|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
410320|NCT00594425|O3|Outcome|Vehicle PDT|
403421|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403422|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403423|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant's MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403424|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403425|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403426|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403427|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403428|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403429|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403430|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403431|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403432|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403472|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403473|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403433|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403434|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403435|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403436|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403437|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403438|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403439|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403440|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403441|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403442|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403443|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403444|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403474|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403475|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403445|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403446|NCT00612105|O2|Outcome|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403447|NCT00612105|O1|Outcome|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403448|NCT00612105|E2|Reported Event|2: Placebo|Arm Description: Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID for up to 6 weeks of the Titration Phase, 4 weeks of the Maintenance Phase, and 3 weeks of the Taper Phase.
403449|NCT00612105|E1|Reported Event|1: Retigabine|Arm Description: Participants started on a total daily dose of 150 milligrams (mg) and were titrated to their maximum tolerated dose (MTD) up to a maximum of 900 mg daily using retigabine 50 mg and/or 100 mg tablets. The dose was increased by 150 mg each week and administered 3 times daily (TID) in equally divided doses. In the Maintenance Phase, retigabine was administered in equally divided doses to maintain the participant’s MTD. Participants with moderate to severe side effects during the first week at their MTD and who had attained at least dose level 3 (450 mg) were allowed a one level dose reduction (150 mg). Participants unable to maintain the MTD discontinued the medication. In the Taper Phase, the dose was reduced by one-third during each of the first two weeks, and the study medication was stopped by the third week during the 3-week duration.
403450|NCT00612066|B1|Baseline|Rosiglitazone|Rosiglitazone maleate :
403451|NCT00612066|P1|Participant Flow|Rosiglitazone|Rosiglitazone maleate :
403452|NCT00612066|O1|Outcome|Rosiglitazone|Rosiglitazone maleate :
403453|NCT00612066|E1|Reported Event|Rosiglitazone|Rosiglitazone maleate :
403454|NCT00612040|B4|Baseline|Total|Total of all reporting groups
403455|NCT00612040|B3|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403456|NCT00612040|B2|Baseline|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403457|NCT00612040|B1|Baseline|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403458|NCT00612040|P3|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403459|NCT00612040|P2|Participant Flow|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403460|NCT00612040|P1|Participant Flow|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403461|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403462|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403463|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403464|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403465|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403466|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403602|NCT00611806|E2|Reported Event|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403476|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403477|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403478|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403479|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403480|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403481|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403482|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403483|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403484|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403485|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403486|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403487|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403488|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403489|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403490|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403491|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403492|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403493|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403494|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403495|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403496|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403497|NCT00612040|O3|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403498|NCT00612040|O2|Outcome|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403499|NCT00612040|O1|Outcome|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403828|NCT00611442|B1|Baseline|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
403500|NCT00612040|E3|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403501|NCT00612040|E2|Reported Event|SIBA (E)|Soluble insulin basal analogue E formulation (SIBA E, 100 dosing unit (DU)/mL (100 DU = 600 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403502|NCT00612040|E1|Reported Event|SIBA (D)|Soluble insulin basal analogue D formulation (SIBA D, 100 dosing unit (DU)/mL (100 DU = 900 nmol), insulin degludec) was given subcutaneously once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal-time insulin for 16 weeks. Insulin doses were individually adjusted.
403503|NCT00611897|B1|Baseline|Overall Sample|This is the group of healthy volunteers that consented to participate in the study.
403504|NCT00611897|P2|Participant Flow|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
403505|NCT00611897|P1|Participant Flow|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
403506|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403507|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403508|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403509|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403510|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403511|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403512|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403513|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403514|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403515|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403516|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403517|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403518|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403519|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403520|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403521|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403522|NCT00611897|O4|Outcome|NAC+Ketamine|NAC active capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403523|NCT00611897|O3|Outcome|NAC+Saline|NAC active capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403524|NCT00611897|O2|Outcome|Placebo+Ketamine|NAC placebo capsule, Ketamine was administered intravenously as a bolus of .29 mg/kg for 40 min.
403525|NCT00611897|O1|Outcome|Placebo+Saline|NAC placebo capsule administered after receiving 1-min bolus of saline, followed by a 70-min long saline infusion during which behavioral, cognitive, and ERP data were collected.
403526|NCT00611897|E2|Reported Event|Day 1: Active NAC; Day 2: Placebo NAC|Subjects were randomized to receive ACTIVE NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received PLACEBO NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
403527|NCT00611897|E1|Reported Event|Day 1: Placebo NAC; Day 2: Active NAC|Subjects were randomized to receive PLACEBO NAC on day one, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order. Subjects then received ACTIVE NAC on day two, before the infusion of saline and then ketamine (as a bolus of .23 mg/kg over 1 min followed by .58 mg/kg for 30 min, and then .29 mg/kg for 40 min) in a fixed order.
403528|NCT00611884|B5|Baseline|Total|Total of all reporting groups
403529|NCT00611884|B4|Baseline|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403829|NCT00611442|P2|Participant Flow|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
403530|NCT00611884|B3|Baseline|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403531|NCT00611884|B2|Baseline|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403532|NCT00611884|B1|Baseline|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403533|NCT00611884|P4|Participant Flow|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403534|NCT00611884|P3|Participant Flow|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403535|NCT00611884|P2|Participant Flow|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403536|NCT00611884|P1|Participant Flow|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403537|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403538|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403539|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403540|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403541|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403542|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403543|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403544|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403545|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403546|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403547|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403548|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403549|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403550|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403830|NCT00611442|P1|Participant Flow|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
403551|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403552|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403553|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403554|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403555|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403556|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403557|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403558|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403559|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403560|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403561|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403562|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403563|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403564|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403565|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403566|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403567|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403568|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403569|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403570|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403571|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403599|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403600|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403572|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403573|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403574|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403575|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403576|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403577|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403578|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403579|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403580|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403581|NCT00611884|O4|Outcome|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403582|NCT00611884|O3|Outcome|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403583|NCT00611884|O2|Outcome|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403584|NCT00611884|O1|Outcome|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403585|NCT00611884|E4|Reported Event|IGlar|Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403586|NCT00611884|E3|Reported Event|SIBA (D) M, W, F|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted.
403587|NCT00611884|E2|Reported Event|SIBA (E)|Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted.
403588|NCT00611884|E1|Reported Event|SIBA (D)|Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted.
403589|NCT00611806|B3|Baseline|Total|Total of all reporting groups
403590|NCT00611806|B2|Baseline|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403591|NCT00611806|B1|Baseline|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403592|NCT00611806|P2|Participant Flow|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403593|NCT00611806|P1|Participant Flow|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403594|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403595|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403596|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403597|NCT00611806|O1|Outcome|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403598|NCT00611806|O2|Outcome|Placebo|"Participants will take placebo for 18 weeks.~Placebo: 1 capsule po daily"
403831|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
403603|NCT00611806|E1|Reported Event|Folate With B12|"Participants will take folic acid plus B12 for 18 weeks.~Folic Acid: Folic acid 2mg po daily~B12: B12 400 micrograms po daily"
403604|NCT00611715|B3|Baseline|Total|Total of all reporting groups
403605|NCT00611715|B2|Baseline|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
403606|NCT00611715|B1|Baseline|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
403607|NCT00611715|P2|Participant Flow|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
403608|NCT00611715|P1|Participant Flow|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
403609|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403610|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403611|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients that had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy
403612|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients that were endocrine treatment-naive in the metastatic setting and more than 12 months from adjuvant endocrine therapy
403613|NCT00611715|O2|Outcome|Second-line/Prev Hormone-therapy tx|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403614|NCT00611715|O1|Outcome|First Line/Hormone-therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403615|NCT00611715|O2|Outcome|Previous Hormone Therapy|Patients who had either received one line of endocrine therapy in the metastatic setting or recurred less than 12 months after completion of endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403616|NCT00611715|O1|Outcome|Hormone Therapy Naive|Patients who were endocrine treatment-naïve in the metastatic setting and more than 12 months from adjuvant endocrine therapy. They received Letrozole 2.5 mg/day and OSI-774 150 mg/day, both orally.
403617|NCT00611715|E2|Reported Event|Second-line/Prev Hormone-therapy tx|Patients who have previously received hormonal therapy
403618|NCT00611715|E1|Reported Event|First Line/Hormone-therapy Naive|Patients who have not received hormonal therapy
403619|NCT00611559|B4|Baseline|Total|Total of all reporting groups
403620|NCT00611559|B3|Baseline|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403621|NCT00611559|B2|Baseline|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403622|NCT00611559|B1|Baseline|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403623|NCT00611559|P3|Participant Flow|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403624|NCT00611559|P2|Participant Flow|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403625|NCT00611559|P1|Participant Flow|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403626|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403627|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403628|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403629|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403630|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403631|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403632|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403633|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403634|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403635|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403636|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403637|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403638|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403639|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403640|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403641|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403642|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403643|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403644|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403645|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403646|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403647|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403648|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403649|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403650|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403651|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403652|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403653|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403654|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403655|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403656|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403657|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403658|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403659|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403660|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403661|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403662|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403663|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403664|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403665|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403666|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403667|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403668|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403669|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403670|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403671|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403672|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403673|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403674|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403675|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403676|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403677|NCT00611559|O3|Outcome|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403678|NCT00611559|O2|Outcome|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403679|NCT00611559|O1|Outcome|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403680|NCT00611559|E3|Reported Event|Infanrix Penta Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ penta
403832|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
403681|NCT00611559|E2|Reported Event|Infanrix Hexa Preservative-containing Formulation Group|Subjects received a booster dose of the preservative-containing formulation of Infanrix™ hexa
403682|NCT00611559|E1|Reported Event|Infanrix Hexa Preservative-free Formulation Group|Subjects received a booster dose of the preservative-free formulation of Infanrix™ hexa
403683|NCT00611468|B1|Baseline|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403684|NCT00611468|P4|Participant Flow|PK Group for Additional PK Data|Additional patients were enrolled for enhanced PK parameter estimation
403685|NCT00611468|P3|Participant Flow|Dosage Level 3 for MTD Determination|Dosage level 3 was topotecan 1.25 mg/m2 and erlotinib 150 mg.
403686|NCT00611468|P2|Participant Flow|Dosage Level 2 for MTD Determination|Dosage level 2 was topotecan 1.0 mg/m2 and erlotinib 150 mg.
403687|NCT00611468|P1|Participant Flow|Dosage Level 1 for MTD Determination|Dosage level 1 was topotecan 0.75 mg/m2 and erlotinib 150 mg.
403688|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403689|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403690|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403691|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403692|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403693|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403694|NCT00611468|O1|Outcome|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403695|NCT00611468|E1|Reported Event|Treatment Group: Intravenous Topotecan and Oral Erlotinib|All subjects received both topotecan and erlotinib. Subjects were assigned to a Dosage Level at the time of enrollment. Dosage level 1 was topotecan 0.75mg/m2 and erlotinib 150mg. Dosage level 2 was topotecan 1.0mg/m2 and erlotinib 150mg. Dosage level 3 was topotecan 1.25mg/m2 and erlotinib 150mg. Topotecan was administered intravenously on days 1 through 5 of each cycle. Erlotinib was administered orally daily. Cycle length was 21 days.
403696|NCT00611455|B3|Baseline|Total|Total of all reporting groups
403697|NCT00611455|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403698|NCT00611455|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403699|NCT00611455|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403700|NCT00611455|P2|Participant Flow|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403701|NCT00611455|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403702|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403703|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403704|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403705|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403706|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403707|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403708|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403709|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403710|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403711|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403712|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403713|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403714|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403715|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403833|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
410321|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
403716|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403717|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403718|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403719|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403720|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403721|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403722|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403723|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403724|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403725|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403726|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403727|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403728|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403729|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403730|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403834|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
410322|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
403731|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403732|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403733|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403734|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403735|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403736|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403737|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403738|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403739|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403740|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403741|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403742|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403743|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403744|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403745|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403835|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
410323|NCT00594425|E3|Reported Event|Vehicle PDT|
403746|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403747|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403748|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403749|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403750|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403751|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403752|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403753|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403754|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403755|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403756|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403757|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403758|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403759|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403760|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403836|NCT00611442|O1|Outcome|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
410324|NCT00594425|E2|Reported Event|80 mg/g MAL PDT|
403761|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403762|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403763|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403764|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403765|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403766|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403767|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403768|NCT00611455|O3|Outcome|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403769|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403770|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403771|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403772|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403773|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403774|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403775|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403776|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403777|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403778|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403779|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403837|NCT00611442|O2|Outcome|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
403780|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403781|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403782|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403783|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403784|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403785|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403786|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403787|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403788|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403789|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403790|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403791|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403792|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403793|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403794|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403795|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403796|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403797|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403798|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403799|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403800|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403801|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403802|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403803|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403804|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
404847|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
403805|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403806|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403807|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403808|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403809|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403810|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403811|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403812|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403813|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403814|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403815|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403816|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403817|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403818|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403819|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403820|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403821|NCT00611455|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403822|NCT00611455|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
403823|NCT00611455|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
403824|NCT00611455|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
403825|NCT00611455|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
403826|NCT00611442|B3|Baseline|Total|Total of all reporting groups
403827|NCT00611442|B2|Baseline|Placebo|split-dose PEG solution without dietary restrictions plus placebo pretreatment
405053|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
403840|NCT00611442|E1|Reported Event|Amitiza|split-dose PEG solution without dietary restrictions plus lubiprostone 24mcg gelcap pretreatment
403841|NCT00611403|B3|Baseline|Total|Total of all reporting groups
403842|NCT00611403|B2|Baseline|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403843|NCT00611403|B1|Baseline|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403844|NCT00611403|P2|Participant Flow|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403845|NCT00611403|P1|Participant Flow|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403846|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403847|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403848|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403849|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403850|NCT00611403|O2|Outcome|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403851|NCT00611403|O1|Outcome|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403852|NCT00611403|E2|Reported Event|REFRESH ENDURA®|Artificial Tears (REFRESH ENDURA®)
403853|NCT00611403|E1|Reported Event|RESTASIS®|Cyclosporine Ophthalmic Emulsion 0.05% (RESTASIS®)
403854|NCT00611325|B3|Baseline|Total|Total of all reporting groups
403855|NCT00611325|B2|Baseline|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403856|NCT00611325|B1|Baseline|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403857|NCT00611325|P2|Participant Flow|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403858|NCT00611325|P1|Participant Flow|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403859|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403860|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403861|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403862|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403863|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403864|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403865|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403866|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403867|NCT00611325|O2|Outcome|Non-EIAED|Patients not taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 1.7 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403868|NCT00611325|O1|Outcome|EIAED|Patients taking enzyme-inducing anti-epileptic drugs (EIAEDs). Avastin was administered intravenously at a dose of 15 mg/kg every 3 weeks. Bortezomib was adminstered intravenously at a dose of 2.5 mg/m2 on days 1, 4, 8, 11, 22, 25, 29, and 32 of a 42-day cycle.
403869|NCT00611325|E2|Reported Event|Non-EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 1.7 mg/m2 for patients not taking EIAEDs."
403870|NCT00611325|E1|Reported Event|EIAED|"Avastin: Avastin was administered intravenously at the dose 15 mg/kg every 3 weeks.~Bortezomib: Bortezomib was administered on days 1, 4, 8, 11, 22, 25, 29, & 32 of a 42-day cycle. Bortezomib was 2.5 mg/m2 for patients taking EIAEDs."
403871|NCT00611247|B3|Baseline|Total|Total of all reporting groups
403872|NCT00611247|B2|Baseline|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403873|NCT00611247|B1|Baseline|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403874|NCT00611247|P2|Participant Flow|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403875|NCT00611247|P1|Participant Flow|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403957|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403876|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403877|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403878|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403879|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403880|NCT00611247|O2|Outcome|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403881|NCT00611247|O1|Outcome|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403882|NCT00611247|E2|Reported Event|Un-Methylated AGAT Promoter (Group 2)|Priming: 100 mg/m2/day oral Temozolomide x 14 days, then followed by Induction: 200 mg/m2/day oral Temozolomide x 7 days
403883|NCT00611247|E1|Reported Event|Methylated AGAT Promoter (Group 1)|Induction: 200 mg/m2/day oral Temozolomide x 7 days
403884|NCT00611130|B3|Baseline|Total|Total of all reporting groups
403885|NCT00611130|B2|Baseline|Placebo|Matching Placebo Tablets. 3 tablets bid.
403886|NCT00611130|B1|Baseline|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
403887|NCT00611130|P2|Participant Flow|Placebo|Matching Placebo Tablets. 3 tablets bid.
403888|NCT00611130|P1|Participant Flow|CPP-109 Vigabatrin|CPP-109 tablets, 500 mg. 3 Tablets bid.
403889|NCT00611130|O1|Outcome|Treatment Phase Completers|Up to 12 urine specimens out of 37 collected during the Treatment Phase completers were analyzed for vigabatrin levels.
403890|NCT00611130|O2|Outcome|Matching Placebo Tablets|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
403891|NCT00611130|O1|Outcome|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks, computerized cognitive behavioral therapy plus contingency management.Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin) and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects attended clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) for efficacy and safety assessments and for treatment during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
403892|NCT00611130|E2|Reported Event|Matching Placebo Tablet|Subjects proceeded to a 12 week Treatment Phase,receiving 3 tablets bid po Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
403893|NCT00611130|E1|Reported Event|CPP-109 Vigabatrin Tablets, 500 mg|Vigabatrin Tablets, 1.5 g bid po, 12 weeks. Subjects proceeded to a 12 week Treatment Phase, including a 2 week dose escalation period, a 9 week maintenance period (3.0 gm/day of vigabatrin), and a 1 week medication taper period. Finally, subjects then proceeded to a 12 week follow-up period. Subjects were scheduled for clinic visits 3 times per week (typically on Monday, Wednesday, and Friday) during the Screening/Baseline Phase and the 12 week Treatment Phase. Subjects returned for follow up visits at Weeks 13, 16, 20 and 24.
403894|NCT00611026|B4|Baseline|Total|Total of all reporting groups
403895|NCT00611026|B3|Baseline|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403896|NCT00611026|B2|Baseline|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403897|NCT00611026|B1|Baseline|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403898|NCT00611026|P3|Participant Flow|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403899|NCT00611026|P2|Participant Flow|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403900|NCT00611026|P1|Participant Flow|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403901|NCT00611026|O2|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403902|NCT00611026|O1|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403903|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403904|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403905|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403906|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403907|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403908|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403909|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403910|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403911|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403912|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403913|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403914|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403915|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403916|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403917|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403918|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403919|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403920|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403921|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403922|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403923|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403924|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403925|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403926|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403927|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403928|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403929|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403930|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403931|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403932|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403933|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403934|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403935|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403936|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403937|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403938|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403939|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403940|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403941|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403942|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403943|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403944|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403945|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403946|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403947|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403948|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403949|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403950|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403951|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403952|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403953|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403954|NCT00611026|O3|Outcome|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403955|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403956|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403958|NCT00611026|O2|Outcome|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403959|NCT00611026|O1|Outcome|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403960|NCT00611026|E3|Reported Event|Fesoterodine|Tablets 4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks.
403961|NCT00611026|E2|Reported Event|Tolterodine ER|Capsules 4 mg PO QD for 12 weeks. Tolterodine Extended Release (ER).
403962|NCT00611026|E1|Reported Event|Placebo|Tablets 4 milligrams (mg) orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks or capsules (4 mg) PO QD for 12 weeks matching to treatment.
403963|NCT00610987|B3|Baseline|Total|Total of all reporting groups
403964|NCT00610987|B2|Baseline|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
403965|NCT00610987|B1|Baseline|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
403966|NCT00610987|P2|Participant Flow|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
403967|NCT00610987|P1|Participant Flow|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
403968|NCT00610987|O2|Outcome|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
403969|NCT00610987|O1|Outcome|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
403970|NCT00610987|E2|Reported Event|Placebo|"Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo, after the intraoperative dose(s) of cefazolin~Placebo: Patients will be randomly assigned to one of two groups. Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group II will receive no additional antibiotic. Instead, they will receive normal saline injection every eight hours as a placebo."
403971|NCT00610987|E1|Reported Event|Cefazolin|"Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours after surgical repair of the closed limb fracture.~cefazolin: Both groups will receive 1 gram (g) of IV cefazolin prior to incision, per standard protocol at our institution. A 2-g dose of cefazolin will be administered IV for patients weighing more than 80 kg. A second 1-g dose of cefazolin will be given three hours later if the patient is still in the operating room. Upon completion of the surgical procedure, Group I will receive 1-g doses of cefazolin every eight hours for the next 24 hours."
403972|NCT00610883|B1|Baseline|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
403973|NCT00610883|P1|Participant Flow|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
403974|NCT00610883|O1|Outcome|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
403975|NCT00610883|E1|Reported Event|All Patients|LSA4, Cyclophosphamide, Methotrexate, Daunomycin, L-asparaginase, BCNU: LSA4 intervention includes three phases: induction, consolidation and maintenance
403976|NCT00610857|B1|Baseline|Interferon Alfa-2b + Tremelimumab|Patients treated with Tremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
403977|NCT00610857|P1|Participant Flow|Interferon Alfa-2b + Tremelimumab|Patients with stage IV melanoma (cutaneous, uveal, or mucosal) and measurable disease, most who had previously received therapy
403978|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
403979|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
403980|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
403981|NCT00610857|O1|Outcome|Interferon Alfa-2b + Tremelimumab|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks
403982|NCT00610857|E1|Reported Event|Interferon Alfa-2b + Tremelimumab (Related and Unrelated AEs)|Patients treated withTremelimumab 15 mg/kg at start of C1 + IFN-2b IV 20 MU/m2/d for 5 d/wk for 4 weeks; C2 onward- IFN-2b SQ 10MU/m2/d for 3 d/wk for 4 weeks per cycle.
403983|NCT00610740|B1|Baseline|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403984|NCT00610740|P1|Participant Flow|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403985|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403986|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403987|NCT00610740|O1|Outcome|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403988|NCT00610740|E1|Reported Event|Patients Treated With CerviPrep™|During routine hysterectomy for endometrial or cervical carcinoma apply topical gemcitabine 100mg/m^2 using CerviPrep™ drug delivery system. CerviPrep™, a novel drug delivery device, was developed specifically for applying pharmaceuticals directly on the cervix. It consists of a syringe-like tube attached to a plastic cap that covers the cervix. Drug can be delivered through the tube, directly to the cervix without spillage onto vaginal or vulvar tissues.
403989|NCT00610714|B3|Baseline|Total|Total of all reporting groups
403990|NCT00610714|B2|Baseline|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
403991|NCT00610714|B1|Baseline|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
403992|NCT00610714|P2|Participant Flow|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
403993|NCT00610714|P1|Participant Flow|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
403994|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
403995|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
403996|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
403997|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
403998|NCT00610714|O2|Outcome|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
404044|NCT00610649|B9|Baseline|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
403999|NCT00610714|O1|Outcome|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
404000|NCT00610714|E2|Reported Event|Carboplatin ,Paclitaxel|Carboplatin AUC 6.0 mg/mL/min, Paclitaxel 175 mg/m2 i.v;
404001|NCT00610714|E1|Reported Event|AZD0530 , Paclitaxel , Carboplatin i.v.|AZD0530 175 mg in combination with Carboplatin AUC 6.0 mg/mL/min plus Paclitaxel 175 mg/m2 i.v.; Applies to the group receiving AZD0530 :An initial cohort of patients enrolled in the study were randomised to the 125 mg dose level; once confirmation of the tolerability of AZD0530 175 mg was available from a phase I dose escalation study (D8180C00023), all patients subsequently enrolled were randomised at the 175 mg dose level
404002|NCT00610701|B3|Baseline|Total|Total of all reporting groups
404003|NCT00610701|B2|Baseline|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
404004|NCT00610701|B1|Baseline|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
404005|NCT00610701|P2|Participant Flow|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
404006|NCT00610701|P1|Participant Flow|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
404007|NCT00610701|O2|Outcome|2-lateral Pin Placement|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
404008|NCT00610701|O1|Outcome|1-anterior Pin Placement|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
404009|NCT00610701|E2|Reported Event|2 Lateral|"Lateral~Lateral pin placement: Laterally-placed (side of the leg) femoral external fixator pind"
404010|NCT00610701|E1|Reported Event|1 Anterior|"Anterior~Anterior pin placement: Anteriorly-placed (front of the leg) femoral external fixator pins"
404011|NCT00610688|B4|Baseline|Total|Total of all reporting groups
404012|NCT00610688|B3|Baseline|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404013|NCT00610688|B2|Baseline|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404014|NCT00610688|B1|Baseline|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404015|NCT00610688|P3|Participant Flow|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404016|NCT00610688|P2|Participant Flow|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404017|NCT00610688|P1|Participant Flow|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404018|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404019|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404020|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404021|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404022|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404023|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404024|NCT00610688|O3|Outcome|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404025|NCT00610688|O2|Outcome|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404026|NCT00610688|O1|Outcome|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404027|NCT00610688|E3|Reported Event|4000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 3600IU of Vitamin D
404028|NCT00610688|E2|Reported Event|2000 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a tablet containing 1600IU of Vitamin D
404029|NCT00610688|E1|Reported Event|400 IU|Arm will receive prenatal vitamin with 400IU of Vitamin D along with a placebo tablet containing 0IU of Vitamin D
404030|NCT00610675|B1|Baseline|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404031|NCT00610675|P1|Participant Flow|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404032|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404033|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404034|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404035|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404036|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404037|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404038|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404039|NCT00610675|O1|Outcome|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404040|NCT00610675|E1|Reported Event|Esmirtazapine|One tablet of Esmirtazapine, 4.5 mg daily for up to 52 weeks
404041|NCT00610649|B12|Baseline|Total|Total of all reporting groups
404042|NCT00610649|B11|Baseline|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404043|NCT00610649|B10|Baseline|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404045|NCT00610649|B8|Baseline|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404046|NCT00610649|B7|Baseline|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404047|NCT00610649|B6|Baseline|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404048|NCT00610649|B5|Baseline|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404049|NCT00610649|B4|Baseline|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404050|NCT00610649|B3|Baseline|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404051|NCT00610649|B2|Baseline|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404052|NCT00610649|B1|Baseline|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404053|NCT00610649|P11|Participant Flow|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404054|NCT00610649|P10|Participant Flow|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404055|NCT00610649|P9|Participant Flow|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg once daily (QD). Participants receive MK-8777 for a total of 28 days.
404056|NCT00610649|P8|Participant Flow|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404057|NCT00610649|P7|Participant Flow|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404058|NCT00610649|P6|Participant Flow|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404059|NCT00610649|P5|Participant Flow|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404060|NCT00610649|P4|Participant Flow|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404061|NCT00610649|P3|Participant Flow|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404062|NCT00610649|P2|Participant Flow|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404063|NCT00610649|P1|Participant Flow|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg twice daily (BID) and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404064|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404065|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404066|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
404067|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404068|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404069|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404070|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404071|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404072|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404073|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404074|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404075|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404076|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404077|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
404078|NCT00610649|O3|Outcome|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404079|NCT00610649|O2|Outcome|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404080|NCT00610649|O1|Outcome|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
404081|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404082|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404083|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404201|NCT00610441|O1|Outcome|Placebo|Participants receive placebo BID for 3 weeks.
404084|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404085|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404086|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404087|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404088|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404089|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404090|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404091|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404092|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404093|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404094|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404095|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404096|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404097|NCT00610649|O8|Outcome|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404098|NCT00610649|O7|Outcome|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404099|NCT00610649|O6|Outcome|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404100|NCT00610649|O5|Outcome|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404101|NCT00610649|O4|Outcome|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404102|NCT00610649|O3|Outcome|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404103|NCT00610649|O2|Outcome|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404104|NCT00610649|O1|Outcome|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404105|NCT00610649|E11|Reported Event|Part 2: Placebo|Participants receive placebo BID for 27 days followed by one day of placebo QD. Participants receive placebo for 28 days.
404106|NCT00610649|E10|Reported Event|Part 2: MK-8777 800 mg|Participants receive MK-8777 200 mg BID for 3 days followed by 400 mg BID for 24 days followed by one day of 400 mg QD. Participants receive MK-8777 for a total of 28 days.
404107|NCT00610649|E9|Reported Event|Part 2: MK-8777 200 mg|Participants receive MK-8777 100 mg BID for 27 days followed by one day of 100 mg QD. Participants receive MK-8777 for a total of 28 days.
404108|NCT00610649|E8|Reported Event|Part 1: Block D Placebo|Participants receive placebo BID for a total of 13 days.
404109|NCT00610649|E7|Reported Event|Part 1: Block D MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum dose determined by the results of Block A. Participants receive MK-8777 for a total of 13 days.
404110|NCT00610649|E6|Reported Event|Part 1: Block C Placebo|Participants receive placebo BID for a total of 10 days.
404111|NCT00610649|E5|Reported Event|Part 1: Block C MK-8777|Participants receive MK-8777 initiated at 300 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 10 days.
404112|NCT00610649|E4|Reported Event|Part 1: Block B Placebo|Participants receive placebo BID for a total of 13 days.
404113|NCT00610649|E3|Reported Event|Part 1: Block B MK-8777|Participants receive MK-8777 initiated at 200 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 13 days.
404114|NCT00610649|E2|Reported Event|Part 1: Block A Placebo|Participants receive placebo BID for a total of 16 days.
404115|NCT00610649|E1|Reported Event|Part 1: Block A MK-8777|Participants receive MK-8777 initiated at 100 mg BID and titrated to a maximum of 600 mg BID. Participants receive MK-8777 for a total of 16 days.
404116|NCT00610532|B1|Baseline|All Study Participants|All study participants progressed from intravenous phenytoin alone to intravenous phenytoin plus probenecid
404117|NCT00610532|P1|Participant Flow|All Study Participants|All study participants progressed from receiving intravenous phenytoin alone to intravenous phenytoin plus probenecid.
404118|NCT00610532|O2|Outcome|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
404119|NCT00610532|O1|Outcome|Intravenous Phenytoin Alone|intravenous phenytoin alone
404120|NCT00610532|E2|Reported Event|Intravenous Phenytoin Plus Probenecid|intravenous phenytoin plus probenecid
404121|NCT00610532|E1|Reported Event|Intravenous Phenytoin Alone|intravenous phenytoin alone
404122|NCT00610441|B5|Baseline|Total|Total of all reporting groups
404123|NCT00610441|B4|Baseline|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
404124|NCT00610441|B3|Baseline|MK-8777 RD→PBO|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
404202|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
404125|NCT00610441|B2|Baseline|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
404126|NCT00610441|B1|Baseline|MK-8777 FD→PBO|Participants receive a fixed dose FD of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
404127|NCT00610441|P4|Participant Flow|PBO→MK-8777 RD|Participants receive rising doses of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 2).
404128|NCT00610441|P3|Participant Flow|MK-8777 RD→PBO|Participants receive rising doses (RD) of MK-8777 100-300 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive rising doses of placebo BID for 3 weeks (Treatment Period 2).
404129|NCT00610441|P2|Participant Flow|PBO→MK-8777 FD|Participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks (Treatment Period 2).
404130|NCT00610441|P1|Participant Flow|MK-8777 FD→PBO|Participants receive a fixed dose (FD) of MK-8777 100 mg BID for 3 weeks (Treatment Period 1). After a 2-week placebo washout period, participants receive a fixed dose of placebo BID for 3 weeks (Treatment Period 2).
404131|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404132|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404133|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404134|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404135|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404136|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404137|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404138|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404139|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404140|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404141|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404142|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404143|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404144|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404145|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404146|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404147|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404148|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404149|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404150|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404151|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404152|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404153|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404154|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404155|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404156|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404157|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404158|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404159|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404160|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404203|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
404161|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404162|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404163|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404164|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404165|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404166|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404167|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404168|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404169|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404170|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404171|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404172|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404173|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404174|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404175|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404176|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404177|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404178|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404179|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404180|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404181|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404182|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404183|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404184|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404185|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404186|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404187|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404188|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404189|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404190|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404191|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404192|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404193|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404194|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404195|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404196|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404197|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404198|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404199|NCT00610441|O3|Outcome|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for 3 weeks.
404200|NCT00610441|O2|Outcome|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for 3 weeks.
404205|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404206|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404207|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404208|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404209|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404210|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404211|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404212|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404213|NCT00610441|O4|Outcome|MK-8777 100-300mg: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received rising doses of MK-8777 100-300 mg BID in either Treatment Period 1 or Treatment Period 2.
404214|NCT00610441|O3|Outcome|Placebo: MK-8777 RD→PBO OR PBO→MK-8777 RD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404215|NCT00610441|O2|Outcome|MK-8777 100mg: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received a fixed dose of MK-8777 100 mg BID in either Treatment Period 1 or Treatment Period 2.
404216|NCT00610441|O1|Outcome|Placebo: MK-8777 FD→PBO OR PBO→MK-8777 FD|Participants who received placebo in either Treatment Period 1 or Treatment Period 2.
404217|NCT00610441|E3|Reported Event|MK-8777 100-300mg|Participants receive rising doses of MK-8777 100-300 mg BID for up to 3 weeks.
404218|NCT00610441|E2|Reported Event|MK-8777 100mg|Participants receive a fixed dose of MK-8777 100 mg BID for up to 3 weeks.
404219|NCT00610441|E1|Reported Event|Placebo|Participants receive placebo BID for up to 5 weeks.
404220|NCT00610311|B1|Baseline|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404221|NCT00610311|P1|Participant Flow|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)– 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404222|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404223|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404224|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404225|NCT00610311|O1|Outcome|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~3 x 10^11 anti-gp100:154-162 TCR engineered PBL by intravenous infusion. A minimum of approximately 5 x 10^8 cells will be given.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
410325|NCT00594425|E1|Reported Event|40 mg/g MAL PDT|
404226|NCT00610311|E1|Reported Event|ALVAC Plus Anti-gp100:154-162 TCR PBL + HD IL-2|"ALVAC plus anti-gp100:154-162 T cell receptor (TCR) peripheral blood lymphocytes (PBL) + HD interleukin-2 (IL-2): ALVAC vaccine two hours prior to cell infusion patients will receive 0.5 ml containing a target dose of 10^7 CCID50 (with a range of approximately 10^6.4 to 107.9/mL of the gp100 ALVAC virus subcutaneously in each extremity (total of 4 x 10^7 CCID50/2mL. This will be repeated on day 14.~Aldesleukin (IL2, Proleukin, Recombinant human interleukin 2)- 720,000 IU/kg intravenous over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum 15 doses)"
404227|NCT00610207|B1|Baseline|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
404228|NCT00610207|P1|Participant Flow|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
404229|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
404230|NCT00610207|O1|Outcome|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
404231|NCT00610207|E1|Reported Event|Biodesign® Anal Fistula Plug|"Biodesign is a bioprosthetic material derived from porcine small intestinal submucosa (SIS) that provides mechanical integrity while acting as a scaffold to guide tissue incorporation.~Three single tract fistula patients were lost to follow-up and were excluded from the analysis."
404232|NCT00610155|B1|Baseline|Entire Study Population|Includes all participants enrolled in the study.
404233|NCT00610155|P6|Participant Flow|Tramadol Then Pregabalin Then Placebo|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then matching placebo capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404234|NCT00610155|P5|Participant Flow|Placebo Then Tramadol Then Pregabalin|Matching placebo capsule orally for 7 days in first intervention period; followed by tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404235|NCT00610155|P4|Participant Flow|Pregabalin Then Placebo Then Tramadol|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404236|NCT00610155|P3|Participant Flow|Placebo Then Pregabalin Then Tramadol|Matching placebo capsule orally for 7 days in first intervention period; followed by pregabalin capsule titrated to 150 mg orally twice daily for 7 days in second intervention period; then tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404237|NCT00610155|P2|Participant Flow|Tramadol Then Placebo Then Pregabalin|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in first intervention period; followed by matching placebo capsule orally for 7 days in second intervention period; then pregabalin capsule titrated to 150 mg orally twice daily for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404238|NCT00610155|P1|Participant Flow|Pregabalin Then Tramadol Then Placebo|Pregabalin (PGB) capsule titrated to 150 milligram (mg) orally twice daily for 7 days in first intervention period; followed by tramadol (TMD) sustained release (SR) capsule titrated to 200 mg orally twice daily for 7 days in second intervention period; then matching placebo (PBO) capsule orally for 7 days in third intervention period. A placebo wash-out period of 7 days was maintained between each period.
404239|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404240|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404241|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404242|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404243|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404244|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404245|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404246|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404247|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404248|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404249|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404250|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404251|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404252|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404253|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404254|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404255|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404256|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404257|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404258|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404259|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404260|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404261|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404262|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404263|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404264|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404265|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404266|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404267|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404268|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404269|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404270|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404271|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404272|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404273|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404274|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404275|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404276|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404277|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404278|NCT00610155|O3|Outcome|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404279|NCT00610155|O2|Outcome|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404280|NCT00610155|O1|Outcome|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404281|NCT00610155|E3|Reported Event|Placebo|Matching placebo capsule orally for 7 days in either of the intervention periods.
404282|NCT00610155|E2|Reported Event|Tramadol|Tramadol SR capsule titrated to 200 mg orally twice daily for 7 days in either of the intervention periods.
404283|NCT00610155|E1|Reported Event|Pregabalin|Pregabalin capsule titrated to 150 mg orally twice daily for 7 days in either of the intervention periods.
404284|NCT00610129|B1|Baseline|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
404285|NCT00610129|P1|Participant Flow|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
404286|NCT00610129|O1|Outcome|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
404287|NCT00610129|E1|Reported Event|Patients With Metastatic Neuroendocrine Tumors|Translational Study of MK-0646 in Patients with Metastatic Neuroendocrine Tumors (NET)
404288|NCT00609986|B3|Baseline|Total|Total of all reporting groups
404289|NCT00609986|B2|Baseline|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404290|NCT00609986|B1|Baseline|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404291|NCT00609986|P2|Participant Flow|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404292|NCT00609986|P1|Participant Flow|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404293|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404294|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
405303|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
404295|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404296|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404297|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404298|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404299|NCT00609986|O2|Outcome|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404300|NCT00609986|O1|Outcome|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404301|NCT00609986|E2|Reported Event|Control|The control group will receive subcutaneous insulin injections (NPH or glargine and aspartame) to maintain a blood sugar level between 70-180 mg/dL while hospitalized and after hospitalization subcutaneous insulin to maintain blood sugar levels 90-180 mg/dL.
404302|NCT00609986|E1|Reported Event|Intensive|The experimental group will receive the intravenous regular insulin infusion protocol for the maintenance of blood sugar levels 70-110 mg/dL while hospitalized up to 7 am post operative day #3 and after hospitalization will receive subcutaneous insulin to maintain blood sugar levels 70-140 mg/dL.
404303|NCT00609973|B3|Baseline|Total|Total of all reporting groups
404304|NCT00609973|B2|Baseline|Placebo|Placebo bid
404305|NCT00609973|B1|Baseline|Cipro|Ciprofloxacin 500 mg bid
404306|NCT00609973|P2|Participant Flow|Placebo|Placebo bid
404307|NCT00609973|P1|Participant Flow|Cipro|Ciprofloxacin 500 mg bid
404308|NCT00609973|O2|Outcome|Placebo|Placebo bid
404309|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
404310|NCT00609973|O2|Outcome|Placebo|Placebo bid
404311|NCT00609973|O1|Outcome|Cipro|Ciprofloxacin 500 mg bid
404312|NCT00609973|E2|Reported Event|Placebo|Placebo bid
404313|NCT00609973|E1|Reported Event|Cipro|Ciprofloxacin 500 mg bid
404314|NCT00609947|B1|Baseline|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eluting stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
404315|NCT00609947|P1|Participant Flow|Endeavor Zotarolimus-Eluting Coronary Stent|Zotarolimus-eltuing stent (ZES) implanted using standard percutaneous coronary intervention (PCI) technique via the femoral approach
404316|NCT00609947|O1|Outcome|Primary Analysis Endpoint|
404317|NCT00609947|O1|Outcome|Primary Effectiveness Analysis Endpoint - SVS|The 8-month in-segment diameter stenosis from Endeavor Small Vessel Study (SVS) subects
404318|NCT00609947|E1|Reported Event|Primary Analysis Endpoint|"The first 97 subjects enrolled and implanted with 2.25mm stents~The first 39 subjects enrolled and implanted with 2.5mm stents~The first 40 subjects enrolled and implanted with 2.75mm stents~A supplemental safety analysis group of subjects with 2.25mm stents N=38 (included in 2.25mm group N=135)"
404319|NCT00609869|B1|Baseline|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404320|NCT00609869|P1|Participant Flow|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404321|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404322|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404323|NCT00609869|O1|Outcome|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404324|NCT00609869|E1|Reported Event|Experimental: Lenalidomide and Rituximab|"28 day cycles of Lenalidomide administered orally and Rituximab administered intravenously.~Lenalidomide: Escalating doses starting with of 2.5 mg daily on 28-days cycles.~Rituximab: at 375 mg/m^2 on a weekly basis for the first cycle starting on day 15."
404325|NCT00609804|B3|Baseline|Total|Total of all reporting groups
404326|NCT00609804|B2|Baseline|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404327|NCT00609804|B1|Baseline|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
410326|NCT00594399|B3|Baseline|Total|Total of all reporting groups
404328|NCT00609804|P2|Participant Flow|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404329|NCT00609804|P1|Participant Flow|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404330|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404331|NCT00609804|O1|Outcome|Sorafenib and Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404332|NCT00609804|O2|Outcome|Sorafenib|Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404333|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404334|NCT00609804|O2|Outcome|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404335|NCT00609804|O1|Outcome|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404336|NCT00609804|E2|Reported Event|Sorafenib|Sorafenib: Sorafenib 400 mg twice daily by mouth. Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404337|NCT00609804|E1|Reported Event|Sorafenib+Erlotinib|Sorafenib and Erlotinib: Sorafenib 400 mg twice daily by mouth Erlotinib 150 mg once daily by mouth Study treatment will be given in cycles of 28 days. Patients will be re-staged every 2 treatment cycles (every 8 weeks). Patients with an objective response or stable disease will continue study treatment. Patients will continue until disease progression or intolerable toxicity occurs.
404338|NCT00609765|B1|Baseline|Chemotherapy|Prospective, single arm, Phase II
404339|NCT00609765|P1|Participant Flow|Chemotherapy|Prospective, single arm, Phase II
404340|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
404341|NCT00609765|O1|Outcome|Chemotherapy|Prospective, single arm, Phase II
404342|NCT00609765|E1|Reported Event|Chemotherapy|Prospective, single arm, Phase II
404343|NCT00609739|B1|Baseline|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404344|NCT00609739|P1|Participant Flow|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404345|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404346|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404347|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404348|NCT00609739|O1|Outcome|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404349|NCT00609739|E1|Reported Event|Cytarabine + Mitoxantrone|Patients receive administration of high dose cytosine arabinoside and mitoxantrone followed by hematopoietic cell transplant.
404350|NCT00609674|B3|Baseline|Total|Total of all reporting groups
404351|NCT00609674|B2|Baseline|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404352|NCT00609674|B1|Baseline|Placebo|Placebo nasal spray
404353|NCT00609674|P2|Participant Flow|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404354|NCT00609674|P1|Participant Flow|Placebo|Placebo nasal spray
404355|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404356|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404357|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404358|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404359|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404360|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404361|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404362|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404363|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404364|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404365|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404366|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404367|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404368|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404369|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404370|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404371|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404372|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404373|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404374|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404375|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404376|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404377|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404378|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404379|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404380|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404381|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404382|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404383|NCT00609674|O2|Outcome|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404384|NCT00609674|O1|Outcome|Placebo|Placebo nasal spray
404385|NCT00609674|E2|Reported Event|Fluticasone Furoate 110 mcg|Once-daily fluticasone furoate (FF) nasal spray 110 mcg
404386|NCT00609674|E1|Reported Event|Placebo|Placebo nasal spray
404387|NCT00609622|B3|Baseline|Total|Total of all reporting groups
404388|NCT00609622|B2|Baseline|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404389|NCT00609622|B1|Baseline|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404390|NCT00609622|P2|Participant Flow|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kilogram (mg/kg) administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and a 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404391|NCT00609622|P1|Participant Flow|Sunitinib + mFOLFOX6|Sunitinib 37.5 milligram (mg) capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, lecovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg per square meter (mg/m^2) and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour intravenous (IV) infusion followed by an IV bolus of 5-fluorouracil (5-FU) 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404392|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404393|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404394|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404395|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404396|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404397|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404398|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
410425|NCT00594022|B3|Baseline|Total|Total of all reporting groups
404399|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404400|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404401|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404402|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404403|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404404|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404405|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404406|NCT00609622|O2|Outcome|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404407|NCT00609622|O1|Outcome|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404408|NCT00609622|E2|Reported Event|Bevacizumab + mFOLFOX6|Bevacizumab 5 mg/kg administered as 90 minute IV infusion every 2 weeks along with mFOLFOX6 regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404409|NCT00609622|E1|Reported Event|Sunitinib + mFOLFOX6|Sunitinib 37.5 mg capsule daily administered orally in a 4 weeks on, 2 weeks off intermittent dosing regimen along with a modified combination chemotherapy of fluorouracil, leucovorin and oxaliplatin (mFOLFOX6) regimen consisting of oxaliplatin 85 mg/m^2 and leucovorin 400 mg/m^2 (or levo-leucovorin 200 mg/m^2) as a 2-hour IV infusion followed by an IV bolus of 5-FU 400 mg/m^2 on Day 1 and 46-hour IV infusion of 5-FU 2,400 mg/m^2 on Days 1 and 2 of each 2 week cycle.
404410|NCT00609518|B3|Baseline|Total|Total of all reporting groups
404411|NCT00609518|B2|Baseline|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404412|NCT00609518|B1|Baseline|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404413|NCT00609518|P2|Participant Flow|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404414|NCT00609518|P1|Participant Flow|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404415|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404416|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404417|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404418|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404419|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404420|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404421|NCT00609518|O2|Outcome|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404422|NCT00609518|O1|Outcome|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404423|NCT00609518|E2|Reported Event|Simplified Vitamin and Steroid Schedule + Pemetrexed|Simplified vitamin and steroid schedule to be used with pemetrexed consisting of 2 daily doses of folic acid before first pemetrexed dose and dexamethasone on day of treatment only.
404424|NCT00609518|E1|Reported Event|Standard Vitamin and Steroid Schedule + Pemetrexed|Standard vitamin and steroid schedule that is used with pemetrexed consisting of a minimum of 5 daily doses of folic acid before first pemetrexed dose and dexamethasone on day before, day of, and day after treatment.
404425|NCT00609466|B4|Baseline|Total|Total of all reporting groups
404426|NCT00609466|B3|Baseline|Placebo|Matching Placebo 4 to 6 hourly
404427|NCT00609466|B2|Baseline|Morphine|Morphine IR 30mg 4 to 6 hourly
404428|NCT00609466|B1|Baseline|CG5503|CG5503 IR 75mg 4-6 hourly
404429|NCT00609466|P3|Participant Flow|Placebo|Matching Placebo 4 to 6 hourly
404430|NCT00609466|P2|Participant Flow|Morphine|Morphine IR 30mg 4 to 6 hourly
404431|NCT00609466|P1|Participant Flow|CG5503|CG5503 IR 75mg 4-6 hourly
404432|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404433|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404434|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404435|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404436|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404437|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404438|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404439|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404440|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404441|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404442|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404443|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404444|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404445|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404446|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404447|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404448|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404449|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404450|NCT00609466|O3|Outcome|Placebo|Matching Placebo 4 to 6 hourly
404451|NCT00609466|O2|Outcome|Morphine|Morphine IR 30mg 4 to 6 hourly
404452|NCT00609466|O1|Outcome|CG5503|CG5503 IR 75mg 4-6 hourly
404453|NCT00609466|E3|Reported Event|Placebo|Matching Placebo 4 to 6 hourly
404454|NCT00609466|E2|Reported Event|Morphine|Morphine IR 30mg 4 to 6 hourly
404455|NCT00609466|E1|Reported Event|CG5503|CG5503 IR 75mg 4-6 hourly
404456|NCT00609362|B3|Baseline|Total|Total of all reporting groups
404457|NCT00609362|B2|Baseline|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404458|NCT00609362|B1|Baseline|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404459|NCT00609362|P2|Participant Flow|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404460|NCT00609362|P1|Participant Flow|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404461|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404462|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404463|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404464|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404465|NCT00609362|O2|Outcome|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404466|NCT00609362|O1|Outcome|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404467|NCT00609362|E2|Reported Event|Placebo|25 women 60 to 75 years of age receiving placebo once a day for 14 weeks
404468|NCT00609362|E1|Reported Event|Rosiglitazone|25 women age 60 to 75 years receiving rosiglitazone 8 mg/day
404469|NCT00609167|B3|Baseline|Total|Total of all reporting groups
404470|NCT00609167|B2|Baseline|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404471|NCT00609167|B1|Baseline|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404472|NCT00609167|P2|Participant Flow|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404473|NCT00609167|P1|Participant Flow|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404474|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404475|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404476|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404477|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404478|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404479|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404480|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404481|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404482|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404483|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404484|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404485|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404486|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404487|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404488|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404489|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404490|NCT00609167|O2|Outcome|CyBorD (Bortezomib 1.5mg/m^2)|"Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22"
404491|NCT00609167|O1|Outcome|CyBorD (Bortezomib 1.3mg/m^2)|"Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11~Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22~Dexamethasone 40mg PO days 1-4, 9-12, 17-20"
404492|NCT00609167|E2|Reported Event|CyBorD (Bortezomib 1.5mg/m^2)|Bortezomib 1.5mg/m^2 by IV days 1, 8, 15 & 22 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO cycle 1-2 days 1-4, 9-12, 17-20, cycle 3 and beyond days 1, 8, 15 & 22
404493|NCT00609167|E1|Reported Event|CyBorD (Bortezomib 1.3mg/m^2)|Bortezomib 1.3mg/m^2 by IV days 1, 4, 8 & 11 Cyclophosphamide 300mg/m^2 PO days 1, 8, 15 & 22 Dexamethasone 40mg PO days 1-4, 9-12, 17-20
404494|NCT00608985|B5|Baseline|Total|Total of all reporting groups
404495|NCT00608985|B4|Baseline|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404496|NCT00608985|B3|Baseline|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404497|NCT00608985|B2|Baseline|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404498|NCT00608985|B1|Baseline|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404499|NCT00608985|P4|Participant Flow|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404500|NCT00608985|P3|Participant Flow|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404501|NCT00608985|P2|Participant Flow|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404502|NCT00608985|P1|Participant Flow|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404503|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404504|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404505|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404506|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404507|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404508|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404509|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404510|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404511|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404512|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404513|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404514|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404515|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404516|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404517|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404518|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404519|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404520|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404521|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404522|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404523|NCT00608985|O4|Outcome|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404524|NCT00608985|O3|Outcome|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404525|NCT00608985|O2|Outcome|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404526|NCT00608985|O1|Outcome|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404527|NCT00608985|E4|Reported Event|Zolpidem 10mg|"zolpidem 10 mg~zolpidem : 2 placebo matching almorexant tablets and 1 zolpidem 10 mg over-encapsulated"
404528|NCT00608985|E3|Reported Event|Almorexant 200mg|"almorexant 200 mg~almorexant : 2 100 mg almorexant tablets, and 1 placebo matching over-encapsulated zolpidem"
404529|NCT00608985|E2|Reported Event|Almorexant 100mg|"almorexant 100 mg~almorexant : 1 100 mg almorexant tablet, 1 placebo matching almorexant tablet, and 1 placebo matching over-encapsulated zolpidem"
404530|NCT00608985|E1|Reported Event|Placebo|"Placebo~Placebo : 2 placebo matching almorexant tablets and 1 placebo matching over-encapsulated zolpidem"
404531|NCT00608959|B3|Baseline|Total|Total of all reporting groups
404532|NCT00608959|B2|Baseline|Chlorhexidine 2% (CHG) / Omiganan 1% Gel(Part 1)|25 subjects were treated with chlorhexidine 2% and omiganan 1% in Part 1.
404533|NCT00608959|B1|Baseline|Omiganan 1% Gel (Part 2)|25 subjects were treated with omiganan 1% gel at skin and intravenous (IV) sites in Part 2.
404534|NCT00608959|P1|Participant Flow|Omiganan 1% Gel and Chlorhexidine|"In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen and chlorhexidine applied to 6 matching sites on the contralateral side.Swab cultures were taken at specified timepoints over 72 hours.~In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Swab cultures were taken at specified timepoints over 7 days.In addition subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period."
404535|NCT00608959|O2|Outcome|Chlorhexidine 2%/ Isopropyl Alcohol|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with chlorhexidine/isopropyl alcohol prior to catheter insertion.Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
404536|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Subjects in Part 2 had 2 intravenous (IV) catheters inserted, with one catheter insertion site treated with isopropyl alcohol (prior to insertion) and omiganan 1% gel was applied. Catheter tip samples were taken at pre-specified timepoints over the 7 day period.
404537|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 7 days.
404538|NCT00608959|O2|Outcome|Chlorhexidine 2%(Part 1)|Chlorhexidine 2% solution was applied to 6 sites on the chest and/or abdomen. Swab cultures were obtained at specific timepoints over 3 days.
404539|NCT00608959|O1|Outcome|Omiganan 1% Gel (Part 2)|Omiganan 1% gel was applied to 6 sites across the chest and/or abdomen. Swab cultures were obtained at specified timepoints over a period of 3 days.
404540|NCT00608959|E3|Reported Event|Omiganan 1% (Part 2)|In Part 2 each subject had omiganan 1% gel applied to 6 sites across the chest and/or abdomen.Omiganan 1% gel was applied to one intravenous (IV) catheter site.
404541|NCT00608959|E2|Reported Event|Chlorhexidine|In Part 1 each subject had chlorhexidine 2% applied to 6 sites located across the chest and/or abdomen. In Part 2 subjects had chlorhexidine 2%/isopropyl alcohol applied to one intravenous (IV) catheter site.
404542|NCT00608959|E1|Reported Event|Omiganan 1% Gel (Part 1)|In Part 1 each subject had omiganan 1% gel applied to 6 sites located across the chest and/or abdomen.
404543|NCT00608907|B4|Baseline|Total|Total of all reporting groups
404544|NCT00608907|B3|Baseline|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
404545|NCT00608907|B2|Baseline|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
404546|NCT00608907|B1|Baseline|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
404780|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404547|NCT00608907|P3|Participant Flow|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
404548|NCT00608907|P2|Participant Flow|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
404549|NCT00608907|P1|Participant Flow|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
404550|NCT00608907|O3|Outcome|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
404551|NCT00608907|O2|Outcome|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
404552|NCT00608907|O1|Outcome|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
404553|NCT00608907|E3|Reported Event|VELCADE + Dexamethasone|Treatment arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, dexamethasone 40 mg oral tablet once daily days 1 to 4, and 9 to 12 in cycle 3.
404554|NCT00608907|E2|Reported Event|VELCADE + Rifampicin|Treatment Arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle, rifampicin 600 mg oral tablet once daily days 4 to 10 in cycle 3.
404555|NCT00608907|E1|Reported Event|VELCADE|Control arm, bortezomib 1.3 mg/m^2 IV bolus on days 1, 4, 8, 11 over a 21-day treatment cycle.
404556|NCT00608881|B3|Baseline|Total|Total of all reporting groups
404557|NCT00608881|B2|Baseline|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404558|NCT00608881|B1|Baseline|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404559|NCT00608881|P2|Participant Flow|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404560|NCT00608881|P1|Participant Flow|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404561|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404562|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404563|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404564|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404565|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404566|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404567|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404568|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404569|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404570|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404571|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404572|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404573|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404574|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404575|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404576|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404577|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404578|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404579|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404580|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404581|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404582|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404583|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404584|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404585|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404586|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404587|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404588|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404589|NCT00608881|O2|Outcome|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404590|NCT00608881|O1|Outcome|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404591|NCT00608881|E2|Reported Event|B - Placebo|"Randomized to placebo~placebo: an inactive substance"
404592|NCT00608881|E1|Reported Event|A - Coenzyme Q10 2400 mg/Day|"Randomized to active treatment (coenzyme Q10 2400 mg/day)~coenzyme Q10: 4 - 300 mg CoQ chewable wafers taken orally twice a day"
404593|NCT00608868|B1|Baseline|Gefitinib|gefitinib tablet 250 mg orally
404594|NCT00608868|P1|Participant Flow|Gefitinib|gefitinib tablet 250 mg orally
404595|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
404596|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
404597|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
404598|NCT00608868|O1|Outcome|Gefitinib|gefitinib tablet 250 mg orally
404599|NCT00608868|E1|Reported Event|Gefitinib|gefitinib tablet 250 mg orally
404600|NCT00608842|B5|Baseline|Total|Total of all reporting groups
404601|NCT00608842|B4|Baseline|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404602|NCT00608842|B3|Baseline|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404603|NCT00608842|B2|Baseline|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404604|NCT00608842|B1|Baseline|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404605|NCT00608842|P4|Participant Flow|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404606|NCT00608842|P3|Participant Flow|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404607|NCT00608842|P2|Participant Flow|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404608|NCT00608842|P1|Participant Flow|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404609|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404610|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404611|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404612|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404613|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404614|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404615|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404616|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404617|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404618|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404619|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404620|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404621|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404622|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404623|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404624|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404781|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404625|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404626|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404627|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404628|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404629|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404630|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404631|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404632|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404633|NCT00608842|O4|Outcome|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404634|NCT00608842|O3|Outcome|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404635|NCT00608842|O2|Outcome|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404636|NCT00608842|O1|Outcome|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404637|NCT00608842|E4|Reported Event|Placebo|Participants received matching placebo administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404638|NCT00608842|E3|Reported Event|Deoxycholic Acid 4%|Participants received 4.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404639|NCT00608842|E2|Reported Event|Deoxycholic Acid 2%|Participants received 2.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404640|NCT00608842|E1|Reported Event|Deoxycholic Acid 1%|Participants received 1.0% deoxycholic acid administered at a volume dependent on the size of the lipoma, up to a maximum of 4.8 mL per treatment session, at 28-day intervals for up to a maximum of 4 treatments.
404641|NCT00608829|B1|Baseline|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
404642|NCT00608829|P1|Participant Flow|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
404643|NCT00608829|O1|Outcome|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
404644|NCT00608829|E1|Reported Event|45mm TAG Device Subjects|The TAG device is a flexible, self-expanding stent graft used for endovascular repair of the Descending Thoracic Aorta. The 45 mm TAG device is a true “line extension”, as it is identical to the approved 26-40 mm GORE TAG Thoracic Endoprosthesis, with the exception of the diameter.
404645|NCT00608777|B1|Baseline|Open Label Taclonex|
404646|NCT00608777|P1|Participant Flow|Open Label Taclonex|
404647|NCT00608777|O1|Outcome|Open Label Taclonex|
404648|NCT00608777|E1|Reported Event|Open Label|
404649|NCT00608634|B4|Baseline|Total|Total of all reporting groups
404650|NCT00608634|B3|Baseline|Arm III|Patients apply POH cream (0.76%) as in arm II.
404651|NCT00608634|B2|Baseline|Arm II|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404652|NCT00608634|B1|Baseline|Arm I|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404653|NCT00608634|P3|Participant Flow|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
404654|NCT00608634|P2|Participant Flow|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404655|NCT00608634|P1|Participant Flow|Placbeo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404656|NCT00608634|O3|Outcome|High Dose 0.76% POH|Patients apply POH cream (0.76%) as in arm II.
404657|NCT00608634|O2|Outcome|Low Dose 0.30% POH|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
412269|NCT00588354|B3|Baseline|Total|Total of all reporting groups
404658|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404659|NCT00608634|O3|Outcome|High Dose POH 0.76%|Patients apply POH cream (0.76%) as in arm II.
404660|NCT00608634|O2|Outcome|Low Dose POH 0.30%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404661|NCT00608634|O1|Outcome|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404662|NCT00608634|E3|Reported Event|High Dose POH 0.76%|Patients apply POH cream (0.76%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404663|NCT00608634|E2|Reported Event|Low Dose POH 0.3%|Patients apply perillyl alcohol (POH) cream (0.3%) topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404664|NCT00608634|E1|Reported Event|Placebo|Patients apply a placebo cream topically to each dorsal forearm twice daily for 3 months in the absence of unacceptable toxicity.
404665|NCT00608582|B3|Baseline|Total|Total of all reporting groups
404666|NCT00608582|B2|Baseline|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~The patients then receive a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404667|NCT00608582|B1|Baseline|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404668|NCT00608582|P2|Participant Flow|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404669|NCT00608582|P1|Participant Flow|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404670|NCT00608582|O2|Outcome|Sham rTMS|"These patients receive a series of 10 Sham rTMS treatments, which are identical to the Real rTMS treatments. However, no magnetic pulse is emitted from the coil.~There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment.~The patients then receive a series of 10 Real rTMS treatments.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404671|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real rTMS treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404672|NCT00608582|O2|Outcome|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
404673|NCT00608582|O1|Outcome|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404674|NCT00608582|E2|Reported Event|Sham rTMS|Patients receive a series of 10 Sham Transcranial Magnetic Stimulation, Repetitive (rTMS) treatments, followed by a series of 10 Real rTMS treatments. There is pre-testing, and post-testing at 2 months after the last Sham rTMS treatment. Sham rTMS are identical to the Real rTMS treatments only no magnetic pulse is released. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.
404707|NCT00608543|E1|Reported Event|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
404708|NCT00608530|B3|Baseline|Total|Total of all reporting groups
404782|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404675|NCT00608582|E1|Reported Event|Real rTMS|"These patients receive a series of 10 Real Transcranial Magnetic Stimulation, Repetitive (rTMS) , treatments, only. There is pre-testing, and post-testing at 2 months after the last Real rTMS treatment.~Transcranial Magnetic Stimulation, Repetitive: 10 rTMS treatments (90% of motor threshold, 20 minutes, at 1 Hz) to specific right hemisphere area of brain cortex; 5 days per week for 2 weeks at the Berenson-Allen Center for Noninvasive Brain Stimulation, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA; or at the Neurology Department, Hospital of the University of Pennsylvania, Philadelphia, PA."
404676|NCT00608569|B3|Baseline|Total|Total of all reporting groups
404677|NCT00608569|B2|Baseline|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404678|NCT00608569|B1|Baseline|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404679|NCT00608569|P2|Participant Flow|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404680|NCT00608569|P1|Participant Flow|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404681|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404682|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404683|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404684|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404685|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404686|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404687|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404688|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404689|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404690|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404691|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404692|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404693|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404694|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404695|NCT00608569|O2|Outcome|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404696|NCT00608569|O1|Outcome|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404697|NCT00608569|E2|Reported Event|Non-mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Self-administration of the study treatment (non-mDOT) for 52 weeks.
404698|NCT00608569|E1|Reported Event|mDOT Arm|Oral FTC/TDF+LPV/rtv or TDF+ZDV+LPV/rtv for 52 weeks. Modified directly observed therapy (mDOT) for the first 24 weeks and self-administration for the remaining 28 weeks.
404699|NCT00608543|B1|Baseline|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
404700|NCT00608543|P1|Participant Flow|Open-label Aripiprazole Augmentation|Aripiprazole augmentation of existing escitalopram, citalopram, or sertraline treatment was provided to study participants at a flexible dose between 5-15 mg (based on clinical symptoms and side effects) for 6 weeks
404701|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404702|NCT00608543|O1|Outcome|Spatial Working Memory Between Errors for 6-move Problems|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404703|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404704|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404705|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404706|NCT00608543|O1|Outcome|Open Label Aripiprazole Augmentation|This is a single arm trial in which all participants recieved open label aripiprazole augmentation of their current escitalopram, citalopram or sertraline treatment.
404776|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404709|NCT00608530|B2|Baseline|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
404710|NCT00608530|B1|Baseline|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
404711|NCT00608530|P2|Participant Flow|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not didactic approach"
404712|NCT00608530|P1|Participant Flow|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
404713|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
404714|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
404715|NCT00608530|O2|Outcome|Supportive Care|10 hours of Rogerian (Supportive) Psychotherapy delivered over 8 weeks
404716|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|10 hours of Cognitive Behavioral Therapy delivered over 8 weeks
404717|NCT00608530|O2|Outcome|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapy encourages self-identification of goals and solutions using a supportive but not directive approach"
404718|NCT00608530|O1|Outcome|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms (e.g., pain) and set specifc goals for functioning (e.g., walking 30 minutes daily)."
404719|NCT00608530|E2|Reported Event|Supportive Psychotherapy|"10 hours of Rogerian Psychotherapy delivered over 8 weeks by telephone and face-to-face contact~Rogerian psychotherapy: Rogerian therapists encourage individuals to identify goals and solutions using a supportive, reflective, empathic appraoch rather than a directive or prescriptive approach"
404720|NCT00608530|E1|Reported Event|Cognitive Behavioral Therapy|"10 hours of Cognitive Behavioral Training delivered over 8 weeks by telephone and face-to-face contact~Cognitive behavioral therapy: Cognitive behavioral self-management skills training actively teaches techniques to evaluate and manage symptoms"
404721|NCT00608517|B4|Baseline|Total|Total of all reporting groups
404722|NCT00608517|B3|Baseline|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404723|NCT00608517|B2|Baseline|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404724|NCT00608517|B1|Baseline|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404725|NCT00608517|P3|Participant Flow|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404726|NCT00608517|P2|Participant Flow|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404727|NCT00608517|P1|Participant Flow|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404728|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404729|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404730|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404731|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404732|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404733|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404734|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404735|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404777|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404778|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404736|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404737|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404738|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404739|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404740|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404741|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404742|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404743|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404744|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404745|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours
404746|NCT00608517|O3|Outcome|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404747|NCT00608517|O2|Outcome|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404748|NCT00608517|O1|Outcome|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404749|NCT00608517|E3|Reported Event|Reduced-intensity Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -2 and cyclophosphamide IV over 1 hour on day -6 and undergo total-body irradiation on day -1.
404750|NCT00608517|E2|Reported Event|Adult Myeloablative Conditioning|Patients receive fludarabine phosphate intravenous (IV) over 30 minutes on days -6 to -4, cyclophosphamide IV over 1 hour on days -5 and -4, and undergo total-body irradiation on days -3 to -1.
404751|NCT00608517|E1|Reported Event|Pediatric Myeloablative Conditioning|Patients undergo total-body irradiation on days -7 to -4, and receive cyclophosphamide intravenous (IV) over 1 hour on days -3 and -2, methylprednisolone IV twice daily on days -3 to -1, and anti-thymocyte globulin IV over 4 hours on days -3 to -1.
404752|NCT00608491|B3|Baseline|Total|Total of all reporting groups
404753|NCT00608491|B2|Baseline|Ultrafiltration|Participants will receive ultrafiltration
404754|NCT00608491|B1|Baseline|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404755|NCT00608491|P2|Participant Flow|Ultrafiltration|Participants will receive ultrafiltration
404756|NCT00608491|P1|Participant Flow|Stepped Pharmacologic Care|Stepped care will provide treating physicians with guidelines for the intensification of diuretic therapy and the possible use of vasodilators and inotropes
404757|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404758|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404759|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404760|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404761|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404762|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404763|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404764|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404765|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404766|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404767|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404768|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404769|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404770|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404771|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404772|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404773|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404774|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404775|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404784|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404785|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404786|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404787|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404788|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404789|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404790|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404791|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404792|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404793|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404794|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404795|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404796|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404797|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404798|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404799|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404800|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404801|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404802|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404803|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404804|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404805|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404806|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404807|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404808|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404809|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404810|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404811|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404812|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404813|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404814|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404815|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404816|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404817|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404818|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404819|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404820|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404821|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404822|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404823|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404824|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404825|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404826|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404827|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404828|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404829|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404830|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404831|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404832|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404833|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404834|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404835|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404836|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404837|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404838|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404839|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404840|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404841|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404842|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404843|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404844|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404845|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404846|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404848|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404849|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404850|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404851|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404852|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404853|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404854|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404855|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404856|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404857|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404858|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404859|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404860|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404861|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404862|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404863|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404864|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404865|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404866|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404867|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404868|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404869|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404870|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404871|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404872|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404873|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404874|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404875|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404876|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404877|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404878|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404879|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404880|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404881|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404882|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404883|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404884|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404885|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404886|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404887|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404888|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404889|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404890|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404891|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404892|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404893|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404894|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404895|NCT00608491|O2|Outcome|Ultrafiltration|Participants will receive ultrafiltration
404896|NCT00608491|O1|Outcome|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404897|NCT00608491|E2|Reported Event|Ultrafiltration|Participants will receive ultrafiltration
404898|NCT00608491|E1|Reported Event|Stepped Pharmacologic Care|Participants will receive stepped pharmacologic care
404899|NCT00608426|B3|Baseline|Total|Total of all reporting groups
404900|NCT00608426|B2|Baseline|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404901|NCT00608426|B1|Baseline|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
404902|NCT00608426|P2|Participant Flow|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404903|NCT00608426|P1|Participant Flow|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
405054|NCT00608023|E3|Reported Event|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
404904|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404905|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
404906|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404907|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
404908|NCT00608426|O2|Outcome|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404909|NCT00608426|O1|Outcome|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
404910|NCT00608426|E2|Reported Event|Proactive Care|"Group who will be proactively offered smoking cessation care with their choice of smoking cessation services (telephone care or in-person care).~Proactive Outreach with choice of telephone or in-person smoking cessation services: This group of participants is sent a recruitment letter, then receives a phone call to offer them their choice of smoking cessation services (either telephone care or in-person care)."
404911|NCT00608426|E1|Reported Event|Usual Care|Group who can elect to receive reactive (usual) care for smoking cessation.
404912|NCT00608322|B3|Baseline|Total|Total of all reporting groups
404913|NCT00608322|B2|Baseline|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
404914|NCT00608322|B1|Baseline|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
404915|NCT00608322|P2|Participant Flow|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
404916|NCT00608322|P1|Participant Flow|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
404917|NCT00608322|O2|Outcome|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
404918|NCT00608322|O1|Outcome|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
404919|NCT00608322|E2|Reported Event|Sham (Comparator)|Subjects receive sham inhaled nitric oxide for six hours.
404920|NCT00608322|E1|Reported Event|Inhaled Nitric Oxide|Subjects receive inhaled nitric oxide (40 parts per million) for six hours.
404921|NCT00608244|B1|Baseline|LCP-Tacro|Evaluation of steady state tacrolimus exposure (AUC0-24) and trough levels (C24) in stable liver transplant recipients converted from Prograf to LCP-Tacro in a 3-sequence study design and validate the dose conversion ratio determined in the Phase 1 program.
404922|NCT00608244|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22, patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL."
404923|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
404924|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
404925|NCT00608244|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
404926|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
404927|NCT00608244|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.
404928|NCT00608244|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with Prograf. Adverse Events occurring during the follow up period (Days 22-51) have been counted in the Prograf treatment arm as patients were on Prograf during this period."
404929|NCT00608244|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 5 to 15 ng/mL.~59 patients were enrolled into the study and all 59 were dosed with LCP-Tacro."
404930|NCT00608205|B3|Baseline|Total|Total of all reporting groups
404931|NCT00608205|B2|Baseline|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404932|NCT00608205|B1|Baseline|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404933|NCT00608205|P2|Participant Flow|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404934|NCT00608205|P1|Participant Flow|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404935|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404936|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404937|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404938|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404939|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404940|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404941|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404942|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404943|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404944|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404945|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404946|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404947|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404948|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404949|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404950|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404951|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404952|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404953|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404954|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404955|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404956|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404957|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404958|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404959|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404960|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404961|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404962|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404963|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404964|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404965|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404966|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404967|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404968|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404969|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404970|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404971|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
412396|NCT00587678|B4|Baseline|Total|Total of all reporting groups
404972|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404973|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404974|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404975|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404976|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404977|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404978|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404979|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404980|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404981|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404982|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404983|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404984|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404985|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404986|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404987|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404988|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404989|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404990|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404991|NCT00608205|O2|Outcome|Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404992|NCT00608205|O1|Outcome|Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404993|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404994|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404995|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404996|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404997|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
404998|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
404999|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405000|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405001|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405002|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405003|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405004|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405005|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405006|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405007|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405008|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405009|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405010|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405011|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405012|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405013|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405014|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405015|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405016|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405017|NCT00608205|O2|Outcome|Arm B|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405018|NCT00608205|O1|Outcome|Arm A|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405019|NCT00608205|E2|Reported Event|Arm B: Radiation With Concurrent 5-FU and Cisplatin|Patients undergo radiotherapy as in arm I and receive fluorouracil IV and cisplatin IV continuously on days 1-4 and 22-25 of radiotherapy.
405020|NCT00608205|E1|Reported Event|Arm A: Radiation With Concurrent Cisplatin|Patients undergo full-dose radiotherapy once or twice daily 5 days a week for up to 7 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
405021|NCT00608140|B3|Baseline|Total|Total of all reporting groups
405022|NCT00608140|B2|Baseline|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
405023|NCT00608140|B1|Baseline|1 Medical Therapy Plus Surgical Repair|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
405024|NCT00608140|P2|Participant Flow|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
405025|NCT00608140|P1|Participant Flow|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
405026|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
405027|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
405028|NCT00608140|O2|Outcome|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
405029|NCT00608140|O1|Outcome|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
405030|NCT00608140|E2|Reported Event|2 Medical Therapy Only|Participants will receive optimal medical therapy alone
405031|NCT00608140|E1|Reported Event|1 Medical Therapy Plus Surgery|Participants will receive optimal medical therapy plus surgical mitral valve repair with complete annular ring placement
405032|NCT00608023|B4|Baseline|Total|Total of all reporting groups
405033|NCT00608023|B3|Baseline|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405034|NCT00608023|B2|Baseline|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405035|NCT00608023|B1|Baseline|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
405036|NCT00608023|P3|Participant Flow|Placebo-Tesamorelin (P-T)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405037|NCT00608023|P2|Participant Flow|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405038|NCT00608023|P1|Participant Flow|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 Weeks
405039|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405040|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405041|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
405042|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405043|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405044|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
405045|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405046|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405047|NCT00608023|O1|Outcome|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
405048|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks.
405049|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks.
405050|NCT00608023|O1|Outcome|Tesamorelin (52 Weeks)|Tesamorelin 2 mg/day for 52 weeks
405051|NCT00608023|O3|Outcome|Placebo (26 Weeks) - Tesamorelin (26 Weeks)|Placebo for 26 weeks followed by Tesamorelin 2 mg/day for 26 weeks
405052|NCT00608023|O2|Outcome|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405055|NCT00608023|E2|Reported Event|Tesamorelin (26 Weeks) - Placebo (26 Weeks)|Tesamorelin 2 mg/day for 26 weeks followed by Placebo for 26 weeks
405056|NCT00608023|E1|Reported Event|Tesamorelin 52 Weeks|Tesamorelin 2 mg/day for 52 weeks
405057|NCT00607919|B3|Baseline|Total|Total of all reporting groups
405058|NCT00607919|B2|Baseline|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405059|NCT00607919|B1|Baseline|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405060|NCT00607919|P2|Participant Flow|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405061|NCT00607919|P1|Participant Flow|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 milligram/kilogram/day (mg/kg/day) given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405062|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405063|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405064|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405065|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405066|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405067|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405068|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405069|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405070|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405071|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405072|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405127|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
413221|NCT00585312|O2|Outcome|Placebo|Matching placebo
405073|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405074|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405075|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405076|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405077|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405078|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405079|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405080|NCT00607919|O2|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405081|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405082|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405083|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405084|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405085|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405086|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405087|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405088|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405297|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405089|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405090|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405091|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405092|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405093|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405094|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405095|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405096|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405097|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405098|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405099|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405100|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405101|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405102|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405103|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405104|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
414037|NCT00581542|O1|Outcome|Polytrim Arm|
405105|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405106|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405107|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405108|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405109|NCT00607919|O3|Outcome|ADHD Alone: Atomoxetine|"Participants with attention-deficit/hyperactivity disorder (ADHD) alone treated with Atomoxetine.~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405110|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405111|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405112|NCT00607919|O2|Outcome|ADHD+ Dyslexia (D): Placebo|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Placebo~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405113|NCT00607919|O1|Outcome|ADHD+ Dyslexia (D): Atomoxetine|"Participants with attention-deficit/hyperactivity disorder and comorbid dyslexia (ADHD+D) treated with Atomoxetine~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405114|NCT00607919|E2|Reported Event|Placebo/Atomoxetine|"Participants were assigned to placebo in acute phase and Atomoxetine in open-label phase.~Placebo was packaged in the same way as Atomoxetine, and administered orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with Atomoxetine"
405115|NCT00607919|E1|Reported Event|Atomoxetine/Atomoxetine|"Participants were assigned to Atomoxetine treatment in both acute and open-label phase~Atomoxetine was administered at 1.0 to 1.4 mg/kg/day given orally once daily in the morning for 16 weeks. All eligible participants who completed the double-blind acute phase had the option of participating in a 16-week open-label extension period in which participants were treated with atomoxetine"
405116|NCT00607880|B3|Baseline|Total|Total of all reporting groups
405117|NCT00607880|B2|Baseline|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405118|NCT00607880|B1|Baseline|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405119|NCT00607880|P2|Participant Flow|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405120|NCT00607880|P1|Participant Flow|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405121|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405122|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405123|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405124|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405125|NCT00607880|O2|Outcome|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405126|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405128|NCT00607880|O1|Outcome|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405129|NCT00607880|E2|Reported Event|Vortex Implantable Access Port|Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
405130|NCT00607880|E1|Reported Event|Standard Access Port|Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
405131|NCT00607867|B3|Baseline|Total|Total of all reporting groups
405132|NCT00607867|B2|Baseline|Control Diet|A weight maintenance, control diet consisting 55% carbohydrate, 15% protein, 30% fat
405133|NCT00607867|B1|Baseline|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% carbohydrate, 30% protein, and 40% fat.
405134|NCT00607867|P2|Participant Flow|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405135|NCT00607867|P1|Participant Flow|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405136|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405137|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405138|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405139|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405140|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405141|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405142|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405143|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405144|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405145|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405146|NCT00607867|O2|Outcome|Control Diet|A weight maintenance, control diet 55% CHO, 15% protein, 30% fat
405147|NCT00607867|O1|Outcome|LoBAG30 Diet|A LoBAG30, weight maintenance diet 30% CHO, 30% Pro, 50% fat
405148|NCT00607867|E2|Reported Event|Control Diet|"A weight maintenance, control diet consisting of 55% carbohydrate, 15% protein, 30% fat will be given to subjects on metformin. All food will be provided for 5 weeks.~Control Diet: A control diet consists of 55% of total energy intake as carbohydrate, 15% protein, 30% fat"
405149|NCT00607867|E1|Reported Event|LoBAG30 Diet|"A LoBAG30, weight maintenance diet will be given to subjects on metformin. All food will be provided for 5 weeks.~LoBAG30 diet: A LoBAG30 diet consists of 30% of total energy intake as carbohydrate, 30% protein, and 40% fat."
405150|NCT00607815|B3|Baseline|Total|Total of all reporting groups
405151|NCT00607815|B2|Baseline|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405152|NCT00607815|B1|Baseline|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
405153|NCT00607815|P2|Participant Flow|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405154|NCT00607815|P1|Participant Flow|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
405155|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405156|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
405157|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405158|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
405159|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405160|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
405161|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy~Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405162|NCT00607815|O1|Outcome|Cognitive Processing Therapy|"Cognitive Processing Therapy~Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others."
405163|NCT00607815|O2|Outcome|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405164|NCT00607815|O1|Outcome|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
405165|NCT00607815|E2|Reported Event|Present Centered Therapy|"Present Centered Therapy: Present centered therapy is a supportive counseling model developed by Drs. Foa and Shea. The treatment is called present centered therapy to 1) emphasize the need to focus on the participant's current life and 2) to conceptualize the problems as being caused by PTSD, and in some cases they may have been present for a long period of time. The treatment makes a connection between PTSD and current problems thus making it a more realistic PTSD treatment and still allowing PCT to control for nonspecific therapeutic factors"
405166|NCT00607815|E1|Reported Event|Cognitive Processing Therapy|Cognitive Processing Therapy: CPT is a highly structured protocol in which the client learns the skill of recognizing and challenging dysfunctional cognitions, first about the worst traumatic event and then later with regard to the meaning of the events for current beliefs about self and others.
405167|NCT00607789|B3|Baseline|Total|Total of all reporting groups
405168|NCT00607789|B2|Baseline|Placebo Group|Participants who were randomized to 30-120 mg/day of sugar pill for 12 weeks
405169|NCT00607789|B1|Baseline|Duloxetine Group|Participants were randomized to 30-120 mg/day of duloxetine for 12 weeks
405170|NCT00607789|P2|Participant Flow|Placebo Group|Placebo tablets (identical to duloxetine tablets), 30-120 mg/d given over 12-week period
405171|NCT00607789|P1|Participant Flow|Duloxetine Group|30-120 mg/day of duloxetine during a 12-week period
405172|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
405173|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
405174|NCT00607789|O2|Outcome|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
405175|NCT00607789|O1|Outcome|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks
405176|NCT00607789|E2|Reported Event|Placebo Group|Participants randomized to 30-120 mg/day of sugar pill for 12 weeks
405177|NCT00607789|E1|Reported Event|Duloxetine Group|Participants randomized to 30-120 mg/day of duloxetine for 12 weeks.
405178|NCT00607724|B8|Baseline|Total|Total of all reporting groups
405179|NCT00607724|B7|Baseline|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability
405180|NCT00607724|B6|Baseline|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405181|NCT00607724|B5|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405182|NCT00607724|B4|Baseline|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405183|NCT00607724|B3|Baseline|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405184|NCT00607724|B2|Baseline|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405298|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405299|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405185|NCT00607724|B1|Baseline|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405186|NCT00607724|P7|Participant Flow|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405187|NCT00607724|P6|Participant Flow|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405188|NCT00607724|P5|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405189|NCT00607724|P4|Participant Flow|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405190|NCT00607724|P3|Participant Flow|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405191|NCT00607724|P2|Participant Flow|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405192|NCT00607724|P1|Participant Flow|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 milligram (mg) on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression (deterioration of evaluable lesions and/or tumor-related symptoms defined using Response Evaluation Criteria in Solid Tumors Version 1.0 (RECIST v1.0), maximum benefit, or intolerability.
405193|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405194|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405195|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405196|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405197|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405198|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405199|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405200|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405201|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405202|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405203|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405204|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405205|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405206|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405300|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405301|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405207|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405208|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405209|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405210|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405211|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405212|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405213|NCT00607724|O6|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405214|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405215|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405216|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405217|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405218|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405219|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405220|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405221|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405222|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405223|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405224|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405225|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405226|NCT00607724|O1|Outcome|All Participants|Included all participants from Stage 1 and Stage 2.
405227|NCT00607724|O1|Outcome|Stage 1: GDC-0449|Included participants with any tumor who received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg, 270 mg and 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, 270 mg and 540 mg orally, continuing until disease progression, maximum benefit, or intolerability.
405228|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405229|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405230|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405231|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405232|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405233|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405234|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405235|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405236|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405237|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405238|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405239|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405240|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405241|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405242|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405243|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405244|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405245|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405246|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405247|NCT00607724|O2|Outcome|Stage 1+Stage 2: GDC-0449 (270 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 270 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405248|NCT00607724|O1|Outcome|Stage 1+Stage 2: GDC-0449 (150 mg)|Participants with any tumor or BCC or safety expansion cohort received single or daily oral dose of GDC-0449 hard gelatin capsules at 150 mg starting on Day 1 (Stage 1 and Stage 2) and/or Day 8 (Stage 1), until disease progression, maximum benefit, or intolerability.
405249|NCT00607724|O4|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405250|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405251|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405252|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405302|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
414038|NCT00581542|E2|Reported Event|Polytrim Treatment Group|
405253|NCT00607724|O7|Outcome|Stage 2: New Formulation (GDC-0449 [150 mg])|Participants received GDC-0449 Phase II drug product as 150-mg hard gelatin capsules daily, orally, starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405254|NCT00607724|O6|Outcome|Stage 2:Safety Expansion Cohort (GDC-0449 [150 mg])|Participants received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405255|NCT00607724|O5|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [270 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405256|NCT00607724|O4|Outcome|Stage 2: Basal Cell Carcinoma (GDC-0449 [150 mg])|Participants with BCC received a daily oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405257|NCT00607724|O3|Outcome|Stage 1: GDC-0449 (540 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 540 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 540 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405258|NCT00607724|O2|Outcome|Stage 1: GDC-0449 (270 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 270 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 270 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405259|NCT00607724|O1|Outcome|Stage 1: GDC-0449 (150 mg)|Participants with any tumor received a single oral dose of GDC-0449 hard gelatin capsules at a dosage of 150 mg on Day 1. Beginning on Day 8, participants received once daily doses of GDC-0449 150 mg, orally, continuing until disease progression, maximum benefit, or intolerability.
405260|NCT00607724|E7|Reported Event|Stage 2: New Formulation [GDC-0449 (150 mg )]|Participants received a daily oral dose of GDC-0449 Phase II drug product hard gelatin capsules at a dosage of 150 mg starting on Day 1 and continuing until disease progression, maximum benefit, or intolerability.
405261|NCT00607724|E6|Reported Event|Stage 2:Safety Expansion Cohort [GDC-0449 (150 mg)]|Participants with tolerable safety, pharmacokinetic and pharmacodynamic data from Stage 1 received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
405262|NCT00607724|E5|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (270 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1 until disease progression, maximum benefit, or intolerability.
405263|NCT00607724|E4|Reported Event|Stage 2: Basal Cell Carcinoma [GDC-0449 (150 mg)]|Participants with basal cell carcinoma (BCC) received daily dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1 until disease progression, maximum benefit, or intolerability.
405264|NCT00607724|E3|Reported Event|Stage 1: GDC-0449 (540 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 540 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
405265|NCT00607724|E2|Reported Event|Stage 1: GDC-0449 (270 mg)|Stage 1: GDC-0449 (270 mg) Participants received single dose of GDC-0449 hard gelatin capsules at 270 mg on Day 1, thereafter Day 8 received daily dose until disease progression, maximum benefit, or intolerability.
405266|NCT00607724|E1|Reported Event|Stage 1: GDC-0449 (150 mg)|Participants received single dose of GDC-0449 hard gelatin capsules at 150 mg on Day 1, thereafter Day 8 received daily until disease progression, maximum benefit, or intolerability.
405267|NCT00607672|B4|Baseline|Total|Total of all reporting groups
405268|NCT00607672|B3|Baseline|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405269|NCT00607672|B2|Baseline|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405270|NCT00607672|B1|Baseline|Placebo|Patients are randomized to placebo prior to surgery
405271|NCT00607672|P3|Participant Flow|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405272|NCT00607672|P2|Participant Flow|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405273|NCT00607672|P1|Participant Flow|Placebo|Patients are randomized to placebo prior to surgery
405274|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
405275|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
405276|NCT00607672|O1|Outcome|Placebo|Placebo group
405277|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
405278|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
405279|NCT00607672|O1|Outcome|Placebo|Placebo group
405280|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
405281|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
405282|NCT00607672|O1|Outcome|Placebo|Placebo group
405283|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405284|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405285|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405286|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405287|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405288|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405289|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405290|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405291|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405292|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405293|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405294|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405295|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405296|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405304|NCT00607672|O3|Outcome|Candesartan (ARB)|Patients are randomized to Candesartan 16mg/d (ARB) prior to surgery.
405305|NCT00607672|O2|Outcome|Ramipril (ACEI)|Ramipril 2.5mg day 1 and 2 and then 5mg/d thereafter
405306|NCT00607672|O1|Outcome|Placebo|Patients are randomized to placebo prior to surgery
405307|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
405308|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
405309|NCT00607672|O1|Outcome|Placebo|Placebo group
405310|NCT00607672|O3|Outcome|Candesartan (ARB)|Angiotensin receptor blocker group
405311|NCT00607672|O2|Outcome|Ramipril (ACEI)|Angiotensin-converting enzyme group
405312|NCT00607672|O1|Outcome|Placebo|Placebo group
405313|NCT00607672|E3|Reported Event|Candesartan (ARB)|Angiotensin receptor blocker group
405314|NCT00607672|E2|Reported Event|Ramipril (ACEI)|Angiotensin-converting enzyme group
405315|NCT00607672|E1|Reported Event|Placebo|Placebo group
405316|NCT00607594|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
405317|NCT00607594|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
405318|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
405319|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO, at a dose of 175 mg QD in the absence of disease progression or unacceptable toxicity.~saracatinib: Patients receive AZD0530 (saracatinib) PO QD in the absence of disease progression or unacceptable toxicity."
405320|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
405321|NCT00607594|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.
405322|NCT00607594|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|"Patients receive saracatinib PO QD in the absence of disease progression or unacceptable toxicity.~saracatinib~laboratory biomarker analysis: Correlative studies"
405323|NCT00607477|B3|Baseline|Total|Total of all reporting groups
405324|NCT00607477|B2|Baseline|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
405325|NCT00607477|B1|Baseline|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
405326|NCT00607477|P2|Participant Flow|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
405327|NCT00607477|P1|Participant Flow|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
405328|NCT00607477|O2|Outcome|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
405329|NCT00607477|O1|Outcome|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
405330|NCT00607477|E2|Reported Event|Minoxidil|2.5 mg Minoxidil taken twice daily for 1 week, followed by 5 mg taken twice daily for the next week, followed by 10 mg twice daily for the next week
405331|NCT00607477|E1|Reported Event|Hydralazine|25 mg Hydralazine taken twice daily for 1 week, followed by 50 mg taken twice daily for the next week, followed by 100 mg twice daily for the next week
405332|NCT00607386|B1|Baseline|Idursulfase|Open-label treatment with idursulfase
405333|NCT00607386|P1|Participant Flow|Idursulfase|Open-label treatment with idursulfase
405334|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405335|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405336|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405337|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405338|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405339|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405340|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405341|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405342|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405343|NCT00607386|O1|Outcome|Idursulfase|Open-label treatment with idursulfase
405344|NCT00607386|E1|Reported Event|Idursulfase|Open-label treatment with idursulfase
405345|NCT00607373|B3|Baseline|Total|Total of all reporting groups
405346|NCT00607373|B2|Baseline|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405347|NCT00607373|B1|Baseline|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405348|NCT00607373|P2|Participant Flow|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405349|NCT00607373|P1|Participant Flow|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405350|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405351|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405352|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405353|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405354|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405355|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
414039|NCT00581542|E1|Reported Event|Moxifloxacin Treatment Group|
405356|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405357|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405358|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405359|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405360|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405361|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405362|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405363|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405364|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405365|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405366|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405367|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405368|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405369|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405370|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405371|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405372|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405373|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405374|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405375|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405376|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405377|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405378|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405379|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405380|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405381|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405382|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405383|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405384|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405385|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405386|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405387|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405388|NCT00607373|O2|Outcome|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405389|NCT00607373|O1|Outcome|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405390|NCT00607373|E2|Reported Event|Mipomersen|Participants received mipomersen 200 mg as a subcutaneous injection once a week for 26 weeks.
405391|NCT00607373|E1|Reported Event|Placebo|Participants received placebo as a subcutaneous injection once a week for 26 weeks
405392|NCT00607321|B1|Baseline|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
405393|NCT00607321|P1|Participant Flow|Medtronic Bifurcation Stent System|Single arm, All patients single de novo bifurcation lesions; 7 run-in subjects not included in analysis
405394|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
405395|NCT00607321|O1|Outcome|Bifurcation Stent System|Evaluable patients within pre-specified follow up window
405396|NCT00607321|O1|Outcome|Bifurcation Stent System|
405397|NCT00607321|O1|Outcome|Bifurcation Stent System|
405398|NCT00607321|O1|Outcome|Subjects Receiving Bifurcation Stents|
405399|NCT00607321|E1|Reported Event|1. Branch Bifurcation Stent System|All subjects enrolled in the BRANCH study
405400|NCT00607269|B3|Baseline|Total|Total of all reporting groups
405401|NCT00607269|B2|Baseline|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405402|NCT00607269|B1|Baseline|Control|Control condition receiving minimal incentives for service program attendance and participation.
405403|NCT00607269|P2|Participant Flow|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405404|NCT00607269|P1|Participant Flow|Control|Control condition receiving minimal incentives for service program attendance and participation.
405442|NCT00607113|P2|Participant Flow|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405405|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405406|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
405407|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405408|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
405409|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405410|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
405411|NCT00607269|O2|Outcome|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405412|NCT00607269|O1|Outcome|Control|Control condition receiving minimal incentives for service program attendance and participation.
405413|NCT00607269|E2|Reported Event|Contingency Management|Contingency management (Voucher-Based Reinforcement Therapy) intervention providing positive reinforcement for service program participation and attendance, enactment of prosocial/health behavior, and/or clean urine samples (i.e., no illicit drug use) and clean breathalyzer tests (i.e., BA < 0.05).
405414|NCT00607269|E1|Reported Event|Control|Control condition receiving minimal incentives for service program attendance and participation.
405415|NCT00607243|B3|Baseline|Total|Total of all reporting groups
405416|NCT00607243|B2|Baseline|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
405417|NCT00607243|B1|Baseline|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
405418|NCT00607243|P2|Participant Flow|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
405419|NCT00607243|P1|Participant Flow|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
405420|NCT00607243|O2|Outcome|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
405421|NCT00607243|O1|Outcome|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
405422|NCT00607243|E2|Reported Event|Low-dose Group|Diluted CJ-50300 2.5 x 10000pfu/dose vaccination
405423|NCT00607243|E1|Reported Event|Conventional-dose Group|Conventional CJ-50300 2.5 x 100000pfu/dose vaccination
405424|NCT00607126|B3|Baseline|Total|Total of all reporting groups
405425|NCT00607126|B2|Baseline|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405426|NCT00607126|B1|Baseline|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405427|NCT00607126|P2|Participant Flow|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405428|NCT00607126|P1|Participant Flow|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405429|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405443|NCT00607113|P1|Participant Flow|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405430|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405431|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405432|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405433|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405434|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405435|NCT00607126|O2|Outcome|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405436|NCT00607126|O1|Outcome|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405437|NCT00607126|E2|Reported Event|Resistive Training|"resistive training using weights and therabands~This group trained for the same amount of time as the Lokomat group, i.e.3X/week for 30-40 minutes per session. they used resistive weights and /or theraband resistive bands to accomplish training. Exercises were done in supine, lying sitting and standing positions. Large muscle groups in both upper and lower extremities were trained. Patients completed 3 sets of 8-12 reps of each exercise, and performed 8-10 different exercises in each session."
405438|NCT00607126|E1|Reported Event|Lokomat Training Using Body Weight Support on a Treadmill|Locomotor training using body weight support on a treadmill, using robotic device to provide locomotor training. Locomotor training will be done using the Lokomat device. The Lokomat device is a robotic exoskeleton which fits over the patient's legs while they are suspended in a harness over a standard treadmill. the patient is suspended over a treadmill while their legs are in the Lokomat, which moves the legs on the treadmill. Patient had to be ambulatory with or without an assistive device. The amount of body weight support is gradually increased or decreased as needed.Partients were also given feedback by the physical therapist while they were walking on the treadmill. Patients trained for 30-40 minutes per session, for 3X/week. The average speed of training was 2.4km.hr. After lokomat training, the patients practiced over ground walking with the therapist for 15 minutes after each session.
405439|NCT00607113|B3|Baseline|Total|Total of all reporting groups
405440|NCT00607113|B2|Baseline|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405441|NCT00607113|B1|Baseline|Avastin|Cycle 1: (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV), Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405603|NCT00606944|O1|Outcome|Control Group|traditional, conventional care group
405444|NCT00607113|O2|Outcome|RAD001|Cycle 1: (First 3 weeks of study) - RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405445|NCT00607113|O1|Outcome|Avastin|Cycle 1 (First 3 weeks of study) - Avastin 15 mg/kg intravenous (IV) or RAD001 10 mg orally daily for 21 Days, Cycle 2: Avastin 15 mg/kg IV every 3 weeks, RAD001 10 mg orally daily for 3 weeks
405446|NCT00607113|E1|Reported Event|Avastin + RAD001|One agent (RAD001 or Avastin) then adding the second agent (Avastin or RAD001): Avastin 15 mg/kg intravenous (IV) every 3 weeks + RAD001 10 mg orally daily for 21 Days
405447|NCT00607087|B4|Baseline|Total|Total of all reporting groups
405448|NCT00607087|B3|Baseline|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
405449|NCT00607087|B2|Baseline|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
405450|NCT00607087|B1|Baseline|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
405451|NCT00607087|P3|Participant Flow|Sequence 3|insulin lispro / insulin glulisine / insulin aspart
405452|NCT00607087|P2|Participant Flow|Sequence 2|insulin aspart / insulin lispro / insulin glulisine
405453|NCT00607087|P1|Participant Flow|Sequence 1|insulin glulisine / insulin aspart / insulin lispro
405454|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405455|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405456|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405457|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405458|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405459|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405460|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405461|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405462|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405463|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405464|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405465|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405466|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405467|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405468|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405469|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405470|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405471|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405472|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405473|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405474|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405475|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405476|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405477|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405478|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405479|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405480|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405481|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405482|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405483|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405484|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405485|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405486|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405487|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405488|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405489|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405490|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405491|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405492|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405493|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405494|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405495|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405496|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405497|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405498|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405499|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405500|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405501|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405502|NCT00607087|O3|Outcome|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405503|NCT00607087|O2|Outcome|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405504|NCT00607087|O1|Outcome|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405505|NCT00607087|E3|Reported Event|Insulin Lispro|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405506|NCT00607087|E2|Reported Event|Insulin Aspart|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405507|NCT00607087|E1|Reported Event|Insulin Glulisine|100 U/ml, administration by Continuous Subcutaneous Insulin Infusion with external pump
405508|NCT00607048|B3|Baseline|Total|Total of all reporting groups
405509|NCT00607048|B2|Baseline|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405510|NCT00607048|B1|Baseline|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort).~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405511|NCT00607048|P6|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405512|NCT00607048|P5|Participant Flow|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405513|NCT00607048|P4|Participant Flow|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405514|NCT00607048|P3|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405515|NCT00607048|P2|Participant Flow|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405516|NCT00607048|P1|Participant Flow|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405517|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405604|NCT00606944|E2|Reported Event|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
405605|NCT00606944|E1|Reported Event|Control Group|traditional, conventional care group
405518|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405519|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405520|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405521|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405522|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405523|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405524|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405525|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405526|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405527|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405528|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405529|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405530|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405531|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405532|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405533|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405534|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405613|NCT00606905|B2|Baseline|Normal Saline|equivalent volume of normal saline
405535|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405536|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405537|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405538|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405539|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405540|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405541|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405542|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405543|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405544|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405545|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405546|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405547|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405548|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405549|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405550|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405606|NCT00606931|B1|Baseline|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405607|NCT00606931|P1|Participant Flow|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405551|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405552|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405553|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405554|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405555|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405556|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405557|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405558|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405559|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405560|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405561|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405562|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405563|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405564|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405565|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405566|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405567|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405608|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405568|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405569|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405570|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405571|NCT00607048|O2|Outcome|Schedule B - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405572|NCT00607048|O1|Outcome|Schedule A - CP-870893|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort). If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405573|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405574|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405575|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405576|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405577|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405578|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405579|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405580|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405581|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405609|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405610|NCT00606931|O1|Outcome|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405611|NCT00606931|E1|Reported Event|PET Guided Biopsy|No comparison group. All enrolled participants were expected to undergo PET guided biopsy.
405582|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405583|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405584|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405585|NCT00607048|O6|Outcome|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort).
405586|NCT00607048|O5|Outcome|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405587|NCT00607048|O4|Outcome|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405588|NCT00607048|O3|Outcome|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle. If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort).
405589|NCT00607048|O2|Outcome|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405590|NCT00607048|O1|Outcome|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405591|NCT00607048|E6|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the MTD. Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405592|NCT00607048|E5|Reported Event|Schedule B - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 8 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405593|NCT00607048|E4|Reported Event|Schedule B - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 8 of every 21 day cycle with starting dose of 0.1 mg/kg (0.1 mg/kg cohort)."
405594|NCT00607048|E3|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Expansion Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.2 mg/kg cohort (escalation cohort) experienced a dose limiting toxicity in Cycle 1, 0.2 mg/kg was considered the maximum tolerated dose (MTD). Additional participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg expansion cohort)."
405595|NCT00607048|E2|Reported Event|Schedule A - CP-870893 0.2 mg/kg (Escalation Cohort)|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) IV on Day 1 of every 21 day cycle.~If 0 out of 3 or <2 out of 6 participants in the CP-870893 0.1 mg/kg cohort experienced a dose limiting toxicity in Cycle 1, subsequent participants were enrolled in the 0.2 mg/kg dose cohort and received CP-870893 0.2 mg/kg IV on Day 3 of every 21 day cycle (0.2 mg/kg escalation cohort)."
405596|NCT00607048|E1|Reported Event|Schedule A - CP-870893 0.1 mg/kg|"Participants received fixed dose chemotherapy (carboplatin and paclitaxel) intravenously (IV) on Day 1 of every 21 day cycle.~CP-870893 administered IV on Day 3 of every 21 day cycle with starting dose of 0.1 milligrams per kilogram (mg/kg) (0.1 mg/kg cohort)."
405597|NCT00606944|B3|Baseline|Total|Total of all reporting groups
405598|NCT00606944|B2|Baseline|ERP Group|Early rehabilitation program after laparoscopic colon surgery with early oral alimentation and early ambulation
405599|NCT00606944|B1|Baseline|Control Group|traditional, conventional care group
405600|NCT00606944|P2|Participant Flow|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
405601|NCT00606944|P1|Participant Flow|Control Group|traditional, conventional care group
405602|NCT00606944|O2|Outcome|ERP Group|Early rehabilitation program after laparoscopic colorectal surgery with early oral alimentation and early ambulation
405614|NCT00606905|B1|Baseline|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
405615|NCT00606905|P2|Participant Flow|Normal Saline|equivalent volume of normal saline
405616|NCT00606905|P1|Participant Flow|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
405617|NCT00606905|O2|Outcome|Normal Saline|equivalent volume of normal saline
405618|NCT00606905|O1|Outcome|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
405619|NCT00606905|E2|Reported Event|Normal Saline|equivalent volume of normal saline
405620|NCT00606905|E1|Reported Event|IVIG|IVIG, either Gamimune N (Talecris Biotherapeutics, Inc., Clayton, NC) or Gamunex 10% (Talecris Biotherapeutics, Inc., Clayton, NC), both as a 10% solution. 500 mg/kg adminstered in the follicular phase of the menstrual cycle. With conception, infusions every four weeks until 18-20 weeks of gestation.
405621|NCT00606892|B1|Baseline|Entire Study Population|Includes all subjects who completed the study. (The total number of subjects who were enrolled in both arms of the study.)
405622|NCT00606892|P2|Participant Flow|Varenicline First, Then Placebo|Subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).After a minimum of washout period of 5 days, then subjects received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg).
405623|NCT00606892|P1|Participant Flow|Placebo First, Then Varenicline|Subject received a placebo tablet once per day for 4 days and then received a laboratory session where they were given ascending dose of Nicotine (0.1,0.4, and 0.7mg per70kg). After a minimum washout period of 5 days,then subjects received Varenicline (1mg) per day for 4 days and then received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, and 0.7mg per 70kg).
405624|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
405625|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
405626|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
405627|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.7mg per 70kg) infusion under the placebo condition.
405628|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.4mg per 70kg) infusion under the placebo condition.
405629|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in systolic and diastolic blood pressure after nicotine (0.1mg per 70kg) infusion under the placebo condition.
405630|NCT00606892|O6|Outcome|Varenicline / High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the varenicline condition.
405631|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the varenicline condition.
405632|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per 70kg) infusion under the varenicline condition.
405633|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.7mg per 70kg) infusion under the placebo condition.
405634|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.4mg per 70kg) infusion under the placebo condition.
405635|NCT00606892|O1|Outcome|Placebo / Low Dose Nicotine|The average peak change (change score) in heart rate after nicotine (0.1mg per70kg) infusion under the placebo condition.
405636|NCT00606892|O6|Outcome|Varenicline/ High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the varenicline condition.
405637|NCT00606892|O5|Outcome|Varenicline/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the varenicline condition.
405638|NCT00606892|O4|Outcome|Varenicline/ Low Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the varenicline condition.
405639|NCT00606892|O3|Outcome|Placebo/High Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the high dose (0.7) of IV nicotine under the placebo condition.
405640|NCT00606892|O2|Outcome|Placebo/ Medium Dose Nicotine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the medium dose (0.4) of IV nicotine under the placebo condition.
405641|NCT00606892|O1|Outcome|Placebo/ Low Dose Nictoine|The average peak change (change score) in the subjective responses to the 7-items of the DEQ to the low dose (0.1) of IV nicotine under the placebo condition.
405642|NCT00606892|O2|Outcome|Varenicline (1 mg)|The mean cotinine levels for subjects under the varenicline condition.
405643|NCT00606892|O1|Outcome|Placebo|The mean cotinine levels for subjects under the placebo condition.
405644|NCT00606892|O4|Outcome|Varenicline, Post-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition and 30 minutes after the nicotine infusions.
405645|NCT00606892|O3|Outcome|Varenicline, Pre-Nicotine|Mean reaction time during modified Stroop task under the varenicline condition prior to the nicotine infusions.
405646|NCT00606892|O2|Outcome|Placebo, Post-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and 30 minutes after the nicotine infusions.
405647|NCT00606892|O1|Outcome|Placebo, Pre-Nicotine|Mean reaction time during modified Stroop task under the placebo condition and prior to the nicotine infusions.
405648|NCT00606892|E6|Reported Event|Varenicline First, Then Placebo, Second Intervention|Subjects crossed-over from the first intervention (varenicline) and received placebo once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
405649|NCT00606892|E5|Reported Event|Placebo First, Then Varenicline, Second Intervention|Subjects crossed-over from the first intervention and received varenicline once per day for 4 days prior to the second laboratory session (second intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
405650|NCT00606892|E4|Reported Event|Adaptation - Varenicline First, Then Placebo|Subjects randomized to the 'Varenicline first' condition first received a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability before receiving the study medication.
405651|NCT00606892|E3|Reported Event|Adaptation - Placebo First, Then Varenicline|Subjects randomized to the 'Placebo first' condition participated in a laboratory session where they were given ascending doses of Nicotine (0.1, 0.4, 0.7mg per 70 kg) to assess tolerability prior to the study medication intervention.
405652|NCT00606892|E2|Reported Event|Varenicline First, Then Placebo, First Intervention|Subjects received varenicline once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
405653|NCT00606892|E1|Reported Event|Placebo First, Then Varenicline, First Intervention|Subjects received a placebo tablet once per day for 4 days prior to the first laboratory session (first intervention) where they were given ascending doses of Nicotine (0.1, 0.7mg per 70kg).
405654|NCT00606801|B3|Baseline|Total|Total of all reporting groups
405655|NCT00606801|B2|Baseline|Placebo|Placebo given for 10 days.
405656|NCT00606801|B1|Baseline|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
405657|NCT00606801|P2|Participant Flow|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
405658|NCT00606801|P1|Participant Flow|Placebo|Placebo given for 10 days.
405659|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
405660|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
405661|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
405662|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
405663|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
405664|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
405665|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
405666|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
405667|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
405668|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
405669|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
405670|NCT00606801|O1|Outcome|Placebo - Baseline|Measures in placebo group prior to medication administration.
405671|NCT00606801|O6|Outcome|Galantamine - Day 10|Measures in galantamine group on Day 10 of medication administration.
405672|NCT00606801|O5|Outcome|Galantamine - Day 5|Measures in galantamine group on Day 5 of medication administration.
405673|NCT00606801|O4|Outcome|Galantamine - Baseline|Measures in galantamine group prior to medication administration.
405674|NCT00606801|O3|Outcome|Placebo - Day 10|Measures in placebo group on Day 10 of medication administration.
405675|NCT00606801|O2|Outcome|Placebo - Day 5|Measures in placebo group on Day 5 of medication administration.
405676|NCT00606801|O1|Outcome|Placebo - Baseline|Measures prior to medication administration.
405677|NCT00606801|E2|Reported Event|Placebo|Placebo given for 10 days.
405678|NCT00606801|E1|Reported Event|Galantamine 8 mg/Day|Galantamine 8 mg/day given for 10 days.
405679|NCT00606684|B7|Baseline|Total|Total of all reporting groups
405680|NCT00606684|B6|Baseline|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405681|NCT00606684|B5|Baseline|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405682|NCT00606684|B4|Baseline|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405683|NCT00606684|B3|Baseline|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405684|NCT00606684|B2|Baseline|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405685|NCT00606684|B1|Baseline|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405807|NCT00606554|P1|Participant Flow|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
405686|NCT00606684|P7|Participant Flow|GW642444M 50 µg|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405687|NCT00606684|P6|Participant Flow|GW642444M 25 µg|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405688|NCT00606684|P5|Participant Flow|GW642444M 12.5 µg|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405689|NCT00606684|P4|Participant Flow|GW642444M 6.25 µg|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405690|NCT00606684|P3|Participant Flow|GW642444M 3 µg|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405691|NCT00606684|P2|Participant Flow|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405692|NCT00606684|P1|Participant Flow|Placebo Run-in|Participants received placebo once daily (OD) in the morning from the novel dual strip dry powder inhaler. In addition, all participants were provided supplemental albuterol (salbutamol) (metered dose inhaler [MDI] and/or nebules) to be used asneeded throughout the study.
405693|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405694|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405695|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405696|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405697|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405698|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405699|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405700|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405701|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405702|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405703|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405704|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405705|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405706|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405707|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405708|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405709|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405710|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405711|NCT00606684|O6|Outcome|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405712|NCT00606684|O5|Outcome|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405713|NCT00606684|O4|Outcome|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405714|NCT00606684|O3|Outcome|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405715|NCT00606684|O2|Outcome|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405716|NCT00606684|O1|Outcome|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405717|NCT00606684|E6|Reported Event|GW642444M 50 µg OD|Participants received GW642444M 50 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405718|NCT00606684|E5|Reported Event|GW642444M 25 µg OD|Participants received GW642444M 25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405719|NCT00606684|E4|Reported Event|GW642444M 12.5 µg OD|Participants received GW642444M 12.5 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405720|NCT00606684|E3|Reported Event|GW642444M 6.25 µg OD|Participants received GW642444M 6.25 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405721|NCT00606684|E2|Reported Event|GW642444M 3 µg OD|Participants received GW642444M 3 µg (one actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405722|NCT00606684|E1|Reported Event|Placebo|Participants received placebo (1 actuation) OD in the morning from the novel dual strip dry powder inhaler for 28 days. In addition, participants were provided supplemental salbutamol (MDI and/or nebules) inhalation to be used as needed throughout the study.
405723|NCT00606632|B1|Baseline|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
405724|NCT00606632|P1|Participant Flow|PET/CT Versus CT|PET/CT and CT scans for all study subjects 4 days (+/- 2 days) after 124I cG250 administration.
405725|NCT00606632|O4|Outcome|Specificity CT|"Specificity of CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
405726|NCT00606632|O3|Outcome|Specificity PET/CT|"Specificity of PET/CT scan for proportion of patients with negative histology (no ccRCC) and evaluable images.~The specificity of refers to the ability of the diagnostic test to correctly identify those patients without the disease (in this case non-ccRCC)."
405727|NCT00606632|O2|Outcome|Sensitivity CT|"Sensitivity of diagnostic CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
405728|NCT00606632|O1|Outcome|Sensitivity PET/CT|"Sensitivity of 124I-cG250 PET/CT scan for proportion of patients with positive histology (ccRCC) and evaluable images.~The sensitivity refers to the ability of the diagnostic test to correctly identify those patients with the disease, in this case ccRCC."
405729|NCT00606632|E1|Reported Event|PET/CT Versus CT|All subjects were scheduled to receive a PET/CT and a diagnostic CT
405730|NCT00606593|B1|Baseline|Patient Flow|The study consisted of a 2-4-week screening phase (including 2 consecutive screening polysomnography (PSG) nights on single blind placebo), a 4- to 8-week treatment phase, and a 28 day safety follow-up. The treatment phase immediately followed randomization and included 5 treatment periods, each consisting of 2 consecutive treatment PSG nights on the assigned study treatment separated by 5 to 12 days of washout. Subjects were randomized to one of 10 treatment sequences.
405731|NCT00606593|P10|Participant Flow|Treatment Sequence 50/100/25/200/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 200 mg/placebo.
405808|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
415246|NCT00578305|B4|Baseline|Total|Total of all reporting groups
405732|NCT00606593|P9|Participant Flow|Treatment Sequence 100/200/50/P/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 200 mg/ACT-078573 50 mg/placebo/ACT-078573 25 mg.
405733|NCT00606593|P8|Participant Flow|Treatment Sequence 200/P/100/25/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 200 mg/placebo/ACT-078573 100 mg/ACT-078573 25 mg/ACT-078573 50 mg.
405734|NCT00606593|P7|Participant Flow|Treatment Sequence P/25/200/50/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 25 mg/ACT-078573 200 mg/ACT-078573 50 mg/ACT-078573 100 mg.
405735|NCT00606593|P6|Participant Flow|Treatment Sequence 25/50/P/100/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/ACT-078573 50 mg/placebo/ACT-078573 100 mg/ACT-078573 200 mg.
405736|NCT00606593|P5|Participant Flow|Treatment Sequence P/200/25/100/50|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: placebo/ACT-078573 200 mg/ACT-078573 25 mg/ACT-078573 100 mg/ACT-078573 50 mg.
405737|NCT00606593|P4|Participant Flow|Treatment Sequence 25/P/50/200/100|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 25 mg/placebo/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 100 mg.
405738|NCT00606593|P3|Participant Flow|Treatment Sequence 50/25/100/P/200|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 50 mg/ACT-078573 25 mg/ACT-078573 100 mg/placebo/ACT-078573 200 mg.
405739|NCT00606593|P2|Participant Flow|Treatment Sequence 100/50/200/25/P|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: ACT-078573 100 mg/ACT-078573 50 mg/ACT-078573 200 mg/ACT-078573 25 mg/placebo.
405740|NCT00606593|P1|Participant Flow|Treatment Sequence 200/100/P/50/25|Study medication was administered in 5 treatment periods, each consisting of 2 consecutive treatment polysomnography (PSG) nights separated by 5-12 days of washout. Treatment consisted of two capsules containing study medication, orally administered on each of the 2 consecutive treatment nights. Treatments were administered in the following sequence: almorexant (ACT-078573) 200 mg/ACT-078573 100 mg/Placebo/ACT-078573 50 mg/ACT-078573 25mg.
405741|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
405742|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
405743|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
405744|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
405745|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
405746|NCT00606593|O5|Outcome|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
405747|NCT00606593|O4|Outcome|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
405748|NCT00606593|O3|Outcome|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
405749|NCT00606593|O2|Outcome|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
405750|NCT00606593|O1|Outcome|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
405751|NCT00606593|E6|Reported Event|ACT-078573 200 mg|Two capsules containing ACT-078573 200 mg, orally administered on each of 2 consecutive nights
405752|NCT00606593|E5|Reported Event|ACT-078573 100 mg|Two capsules containing ACT-078573 100 mg, orally administered on each of 2 consecutive nights
405753|NCT00606593|E4|Reported Event|ACT-078573 50 mg|Two capsules containing ACT-078573 50 mg, orally administered on each of 2 consecutive nights
405754|NCT00606593|E3|Reported Event|ACT-078573 25 mg|Two capsules containing ACT-078573 25 mg, orally administered on each of 2 consecutive nights
405755|NCT00606593|E2|Reported Event|Placebo|Two capsules containing placebo, orally administered on each of 2 consecutive nights
405756|NCT00606593|E1|Reported Event|Single-blind Placebo|Treatment administered during screening period
405757|NCT00606580|B4|Baseline|Total|Total of all reporting groups
405758|NCT00606580|B3|Baseline|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405809|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
405759|NCT00606580|B2|Baseline|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405760|NCT00606580|B1|Baseline|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405761|NCT00606580|P3|Participant Flow|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405762|NCT00606580|P2|Participant Flow|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405763|NCT00606580|P1|Participant Flow|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405764|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405765|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405766|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405767|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405768|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405769|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405770|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405771|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405772|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405773|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405774|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405775|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405776|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405777|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405778|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405779|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405780|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405781|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405782|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405783|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405784|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405785|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405786|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405787|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405788|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405789|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405790|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405791|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405792|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405793|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405794|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405795|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405796|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405797|NCT00606580|O3|Outcome|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405798|NCT00606580|O2|Outcome|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405799|NCT00606580|O1|Outcome|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405800|NCT00606580|E3|Reported Event|Vehicle Placebo Cream|"The cream base without the addition of paromomycin or gentamicin~Vehicle placebo cream: Applied daily to cutaneous leishmaniasis lesions, primarily ulcerative, and covered with a protective, sterile gauze and tape dressing."
405801|NCT00606580|E2|Reported Event|Paromomycin Alone Topical Treatment|"Paromomycin Alone topical cream (15% paromomycin topical cream)~Paromomycin Alone topical cream: The antibiotic paromomycin 15% in the same topical cream used in arm 1 will be applied to lesions daily and covered with a protective sterile gauze and tape dressing."
405802|NCT00606580|E1|Reported Event|WR 279,396 Topical Treament|"WR 279,396 topical cream (15% paromomycin + 0.5% gentamicin topical cream)~WR 279,396 topical cream: WR 279,396 is a topical antibiotic cream containing 15% paromomycin and 0.5% gentamicin that will be applied to each lesion once a day and covered with a sterile gauze and tape dressing."
405803|NCT00606554|B3|Baseline|Total|Total of all reporting groups
405804|NCT00606554|B2|Baseline|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
405805|NCT00606554|B1|Baseline|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
405806|NCT00606554|P2|Participant Flow|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
405810|NCT00606554|O2|Outcome|Standard of Care Weaning|comparator arm
405812|NCT00606554|O2|Outcome|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
405813|NCT00606554|O1|Outcome|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
405814|NCT00606554|E2|Reported Event|Standard of Care|"Group assigned to receive current, evidence-based, standard of care for discontinuation of mechanical ventilation.~Comparator group"
405815|NCT00606554|E1|Reported Event|Computer-assisted Wean|Group assigned to the computer-assisted weaning program Intervention Group
405816|NCT00606502|B3|Baseline|Total|Total of all reporting groups
405817|NCT00606502|B2|Baseline|Erlotinib|
405818|NCT00606502|B1|Baseline|Pralatrexate|
405819|NCT00606502|P2|Participant Flow|Erlotinib|150 mg tablet taken orally daily
405820|NCT00606502|P1|Participant Flow|Pralatrexate|190 or 230 mg/m2 starting dose with increases or decreases to 150 to 270 mg/m2 per protocol, administered as an IV push over 3-5 minutes on days 1 and 15 of a 4-week cycle (ie, every 2 weeks)
405821|NCT00606502|O2|Outcome|Erlotinib|
405822|NCT00606502|O1|Outcome|Pralatrexate|
405823|NCT00606502|O2|Outcome|Erlotinib|
405824|NCT00606502|O1|Outcome|Pralatrexate|
405825|NCT00606502|O2|Outcome|Erlotinib|
405826|NCT00606502|O1|Outcome|Pralatrexate|
405827|NCT00606502|O2|Outcome|Erlotinib|
405828|NCT00606502|O1|Outcome|Pralatrexate|
405829|NCT00606502|E2|Reported Event|Erlotinib|
405830|NCT00606502|E1|Reported Event|Pralatrexate|
405831|NCT00606489|B3|Baseline|Total|Total of all reporting groups
405832|NCT00606489|B2|Baseline|800mg Intravenous Ibuprofen|
405833|NCT00606489|B1|Baseline|Placebo (250 Milliliters Normal Saline)|
405834|NCT00606489|P2|Participant Flow|800mg Intravenous Ibuprofen|
405835|NCT00606489|P1|Participant Flow|Placebo (250 Milliliters Normal Saline)|
405836|NCT00606489|O2|Outcome|800mg Intravenous Ibuprofen|
405837|NCT00606489|O1|Outcome|Placebo (250 Milliliters Normal Saline)|
405838|NCT00606489|E2|Reported Event|800mg Intravenous Ibuprofen|
405839|NCT00606489|E1|Reported Event|Placebo (250 Milliliters Normal Saline)|
405840|NCT00605384|B3|Baseline|Total|Total of all reporting groups
405841|NCT00605384|B2|Baseline|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405842|NCT00605384|B1|Baseline|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405843|NCT00605384|P2|Participant Flow|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405844|NCT00605384|P1|Participant Flow|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405845|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405846|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405847|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405848|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405849|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405850|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405851|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405852|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405853|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405854|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405855|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405856|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405857|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405858|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405859|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405860|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405861|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405862|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405863|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405864|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405865|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405866|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405867|NCT00605384|O2|Outcome|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405868|NCT00605384|O1|Outcome|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405869|NCT00605384|E2|Reported Event|Adefovir + Continuing Lamivudine|Tablets, Oral, Adefovir 10 mg + Lamivudine, 100 mg, once daily, 100 weeks
405870|NCT00605384|E1|Reported Event|Entecavir + Tenofovir|Tablets, Oral, Entecavir 1 mg + Tenofovir 300 mg, once daily, 100 weeks
405871|NCT00605345|B3|Baseline|Total|Total of all reporting groups
405872|NCT00605345|B2|Baseline|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405873|NCT00605345|B1|Baseline|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405874|NCT00605345|P2|Participant Flow|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405875|NCT00605345|P1|Participant Flow|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405876|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405877|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405878|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405879|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405880|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405881|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405882|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405883|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405884|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405885|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405886|NCT00605345|O2|Outcome|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405887|NCT00605345|O1|Outcome|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405888|NCT00605345|E2|Reported Event|Darbepoetin Alfa Once Biweekly|Darbepoetin Alfa as prescribed
405889|NCT00605345|E1|Reported Event|CERA Treatment Once Monthly|CERA 120, 200 or 360 micrograms subcutaneously
405890|NCT00605306|B3|Baseline|Total|Total of all reporting groups
405891|NCT00605306|B2|Baseline|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405892|NCT00605306|B1|Baseline|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405893|NCT00605306|P2|Participant Flow|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405894|NCT00605306|P1|Participant Flow|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405895|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405896|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405897|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405898|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405899|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405900|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405901|NCT00605306|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405902|NCT00605306|O1|Outcome|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405903|NCT00605306|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
405904|NCT00605306|E1|Reported Event|Indacaterol Maleate/Mometasone Furoate|Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days.
405905|NCT00605293|B3|Baseline|Total|Total of all reporting groups
405906|NCT00605293|B2|Baseline|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405907|NCT00605293|B1|Baseline|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405908|NCT00605293|P2|Participant Flow|Epoetin Alfa|Participants received IV injection of 6000 International Units (IU) of epoetin alfa every 3 weeks (q3wk) during the Stability Verification Period (SVP; Week -4 to -1), 7443 IU of epoetin alfa q3wk during Dose Titration Period (DTP; Week 0 to 15), and 7363 IU of epoetin alfa q3wk during Efficacy Evaluation Period (EEP; Week 16 to 23) up to 23 weeks.
405909|NCT00605293|P1|Participant Flow|C.E.R.A|Participants received starting dose of 120, 200 or 360 micrograms (mcg) of C.E.R.A intravenously (IV) once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405910|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405911|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
406246|NCT00605475|B9|Baseline|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
405912|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405913|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405914|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405915|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405916|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405917|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405918|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405919|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405920|NCT00605293|O2|Outcome|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405921|NCT00605293|O1|Outcome|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405922|NCT00605293|E2|Reported Event|Epoetin Alfa|Participants received IV injection of 6000 IU of epoetin alfa q3wk during the SVP (Week -4 to -1), 7443 IU of epoetin alfa q3wk during DTP (Week 0 to 15), and 7363 IU of epoetin alfa q3wk during EEP (Week 16 to 23) up to 23 weeks.
405923|NCT00605293|E1|Reported Event|C.E.R.A|Participants received starting dose of 120, 200 or 360 mcg of C.E.R.A IV once monthly for 6 months. The starting dose was based on the dose of epoetin alfa administered in Week -1.
405924|NCT00605280|B5|Baseline|Total|Total of all reporting groups
405925|NCT00605280|B4|Baseline|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
405926|NCT00605280|B3|Baseline|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from study.
405927|NCT00605280|B2|Baseline|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405928|NCT00605280|B1|Baseline|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405929|NCT00605280|P4|Participant Flow|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405930|NCT00605280|P3|Participant Flow|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. The 0.003 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks up to 2 years or withdrawing from the study.
405931|NCT00605280|P2|Participant Flow|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. The 0.03 mg dose was removed and participants given option of receiving 0.3 mg injection of pegaptanib sodium every 6 weeks for 2 years or withdrawing from the study.
405932|NCT00605280|P1|Participant Flow|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405933|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405934|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405935|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405936|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405997|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406404|NCT00605202|E1|Reported Event|Licorice|Licorice 32 grams a day
405937|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405938|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405939|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405940|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405941|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405942|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405943|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405944|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405945|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405946|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405947|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405948|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405949|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405950|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405951|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405952|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405953|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405954|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405955|NCT00605280|O2|Outcome|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe). Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405956|NCT00605280|O1|Outcome|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks up to 2 years. Eligible participants had option to enroll in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405957|NCT00605280|E6|Reported Event|Sham Conversion (Year 3)|Participants who were originally randomized to Sham who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405958|NCT00605280|E5|Reported Event|0.3 mg Pegaptanib Sodium (Year 3)|Participants who were originally randomized to pegaptanib sodium, 0.3 mg who enrolled in Year 3, open-label, extension phase during which participants received intravitreal injections of pegaptanib sodium, 0.3 mg every 6 weeks for 1 year.
405998|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405959|NCT00605280|E4|Reported Event|Sham|Standard of care and sham injection (the application of an empty barrel of a needleless syringe) from baseline up to Year 2. Events reported for participants after start of sham, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
405960|NCT00605280|E3|Reported Event|0.003 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.003 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
405961|NCT00605280|E2|Reported Event|0.03 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.03 mg every 6 weeks was planned for up to 2 years. Events reported for participants after start of treatment, but before they converted to 0.3 mg pegaptanib sodium or withdrew from study.
405962|NCT00605280|E1|Reported Event|0.3 mg Pegaptanib Sodium|Intravitreal injection of pegaptanib sodium, 0.3 mg every 6 weeks from baseline up to 2 years. Includes participants randomized to 0.3 mg pegaptanib sodium and participants randomized to lower doses of pegaptanib sodium who then converted to 0.3 mg pegaptanib sodium; for participants who converted to 0.3 mg pegaptanib sodium, only events that occurred while receiving 0.3 mg pegaptanib sodium treatment are reported.
405963|NCT00605267|B3|Baseline|Total|Total of all reporting groups
405964|NCT00605267|B2|Baseline|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405965|NCT00605267|B1|Baseline|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405966|NCT00605267|P2|Participant Flow|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405967|NCT00605267|P1|Participant Flow|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405968|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405969|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405970|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405971|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405972|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405973|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405974|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405975|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405976|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405977|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405978|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405979|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405980|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405981|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405982|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405983|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405984|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405985|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405986|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405987|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405988|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405989|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405990|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405991|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405992|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405993|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405994|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405995|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405996|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
405999|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406000|NCT00605267|O2|Outcome|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406001|NCT00605267|O1|Outcome|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406002|NCT00605267|E2|Reported Event|Tamoxifen 20 mg|Tamoxifen (comparator) 20mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406003|NCT00605267|E1|Reported Event|Anastrozole 1 mg|Anastrozole (investigational product) 1mg tablet given once a day orally and goserelin acetate 3.6 mg/ month depot injection
406004|NCT00606320|B1|Baseline|Arupiprazole|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
406005|NCT00606320|P1|Participant Flow|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
406006|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
406007|NCT00606320|O1|Outcome|Aripiprazple|"Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.~Subjects were administered 24, 12, or 30mg/day of aripiprazole once daily for 154 days in an unblinded manner. Subjects were also administered mood stabilizer concomitantly for 154 days."
406008|NCT00606320|E1|Reported Event|Aripiprazole|Patients who had completed the preceding study but whose condition worsened or remained unchanged or who discontinued the preceding study on Day 14 to Day 21 due to lack of drug efficacy were the target.
406009|NCT00606281|B3|Baseline|Total|Total of all reporting groups
406010|NCT00606281|B2|Baseline|Placebo|Subjects were administered placebo once daily for 21 days.
406011|NCT00606281|B1|Baseline|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
406012|NCT00606281|P2|Participant Flow|Placebo|Subjects were administered placebo once daily for 21 days.
406013|NCT00606281|P1|Participant Flow|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
406014|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
406015|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
406016|NCT00606281|O2|Outcome|Placebo|Subjects were administered placebo once daily for 21 days.
406017|NCT00606281|O1|Outcome|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
406018|NCT00606281|E2|Reported Event|Placebo|Subjects were administered placebo once daily for 21 days.
406019|NCT00606281|E1|Reported Event|Aripiprazole|Subjects were administered 24 mg/day of aripiprazole once daily for 21 days. If there was a problem with tolerability, the dose could be reduced to 12 mg/day.
406020|NCT00606229|B1|Baseline|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
406021|NCT00606229|P1|Participant Flow|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
406022|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
406023|NCT00606229|O1|Outcome|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
406024|NCT00606229|E1|Reported Event|Aripiprazole|Twenty-four milligrams of aripiprazole (four 6-mg tablets) were administered orally once daily for 24 weeks (168 days) in an unblinded manner. The dose could be increased to a maximum of 30 mg/day (five 6-mg tablets).
406025|NCT00606177|B3|Baseline|Total|Total of all reporting groups
406026|NCT00606177|B2|Baseline|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
406027|NCT00606177|B1|Baseline|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
406028|NCT00606177|P2|Participant Flow|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
406029|NCT00606177|P1|Participant Flow|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
406030|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
406031|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
406032|NCT00606177|O2|Outcome|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
406033|NCT00606177|O1|Outcome|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
406034|NCT00606177|E2|Reported Event|Placebo|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered placebo once daily for 154 days."
406035|NCT00606177|E1|Reported Event|Aripiprazole|"Patients who had completed the preceding study and demonstrated drug efficacy were the target.~Subjects were administered 24 ,12, or 30 mg/day of aripiprazole once daily for 154 days."
406036|NCT00606138|B3|Baseline|Total|Total of all reporting groups
406037|NCT00606138|B2|Baseline|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406038|NCT00606138|B1|Baseline|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406039|NCT00606138|P2|Participant Flow|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406040|NCT00606138|P1|Participant Flow|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406041|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406042|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406043|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406044|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406045|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406046|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406047|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406048|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406049|NCT00606138|O2|Outcome|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406050|NCT00606138|O1|Outcome|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406051|NCT00606138|E2|Reported Event|2 - Additional PRP Treatment|Additional panretinal photocoagulation (up to 500 300-500 um laser spots)
406052|NCT00606138|E1|Reported Event|1 - Ranibizumab|Intravitreal injection of 0.5-mg dose of ranibizumab
406053|NCT00606086|B3|Baseline|Total|Total of all reporting groups
406054|NCT00606086|B2|Baseline|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
406055|NCT00606086|B1|Baseline|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
406056|NCT00606086|P2|Participant Flow|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
406057|NCT00606086|P1|Participant Flow|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
406058|NCT00606086|O2|Outcome|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
406059|NCT00606086|O1|Outcome|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
406122|NCT00605917|O2|Outcome|Without History of Treatment|Participants without history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
406060|NCT00606086|E2|Reported Event|Arm 2: Peg-IFN/Ribavirin or Peg-IFN/Ribavirin Plus GI-5005|Subjects were treated with 12 weeks of SOC (Peg-IFN plus Ribavirin) therapy. Subjects who achieve an EVR continued to receive SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR, GI-5005 was added to SOC therapy and study drug administration continued for up to an additional 62 weeks. Subjects who discontinued SOC therapy due to intolerance were treated with GI-5005 monotherapy for up to 72 weeks.
406061|NCT00606086|E1|Reported Event|Arm 1: Peg-IFN/Ribavirin Plus GI-5005|Subjects were given GI-5005 alone for 12 weeks (5 weekly followed by 2 monthly doses). After completion of GI-5005 monotherapy run in period peg-IFN/ribavirin (SOC) therapy was added to continued monthly administration of GI-5005 and the subjects were treated for subsequent 12 week period. At the end of this period, subjects who achieve an EVR continued to receive GI-5005 plus SOC therapy for an additional 36 weeks (naive subjects) or an additional 60 weeks (non-responder subjects). Subjects who did not achieve an EVR were followed for safety during a 36 week off treatment period. Any subject who discontinued SOC therapy due to intolerance at or prior to EVR assessment was treated with GI-5005 monotherapy for up to a total of 72 weeks.
406062|NCT00606034|B1|Baseline|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
406063|NCT00606034|P1|Participant Flow|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
406064|NCT00606034|O1|Outcome|All Subjects|All subjects will receive the IDRSQ at baseline and at Week 52
406065|NCT00606034|O1|Outcome|All Subjects|
406066|NCT00606034|O1|Outcome|All Subjects Using U-500 Regular Insulin Via Omnipod|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
406067|NCT00606034|E1|Reported Event|All Subjects Active|All subjects will receive the experimental treatment (U-500 insulin via Omnipod) since they have already failed all other previous insulin treatment regimens.
406068|NCT00606021|B3|Baseline|Total|Total of all reporting groups
406069|NCT00606021|B2|Baseline|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406070|NCT00606021|B1|Baseline|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406071|NCT00606021|P3|Participant Flow|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406072|NCT00606021|P2|Participant Flow|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 (mg/m²), IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406073|NCT00606021|P1|Participant Flow|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
406074|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406075|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406076|NCT00606021|O3|Outcome|Pemetrexed Plus Cisplatin (Induction Phase)|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles
406077|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406078|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406079|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406080|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406081|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406082|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406083|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406084|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406085|NCT00606021|O2|Outcome|Best Supportive Care (Maintenance Phase)|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406086|NCT00606021|O1|Outcome|Pemetrexed Plus Best Supportive Care (Maintenance Phase)|"Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles~Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician."
406087|NCT00606021|E3|Reported Event|Pemetrexed + Cisplatin - Induction Phase|Pemetrexed, 500 milligrams per square meter (mg/m²), intravenous (IV) followed by Cisplatin, IV, 75 mg/m² on Day 1 of each 21-day cycle for 4 cycles.
406244|NCT00605475|B11|Baseline|Total|Total of all reporting groups
406088|NCT00606021|E2|Reported Event|Best Supportive Care - Maintenance Phase|Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406089|NCT00606021|E1|Reported Event|Pemetrexed Plus Best Supportive Care - Maintenance Phase|Pemetrexed: 500 mg/m², IV, Day 1 of each 21-day cycle for 6 cycles Best Supportive Care: Patients will receive best supportive care (dose, frequency, duration) as judged by their treating physician.
406090|NCT00606008|B1|Baseline|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406091|NCT00606008|P1|Participant Flow|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406092|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
406093|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
406094|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406095|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
406096|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
406097|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406098|NCT00606008|O3|Outcome|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
406099|NCT00606008|O2|Outcome|AA Cohort Patients|Recurrent glioblastoma (GB) patients
406100|NCT00606008|O1|Outcome|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406101|NCT00606008|E3|Reported Event|GB Cohort Patients|Anaplastic astrocytoma (AA)patients
406102|NCT00606008|E2|Reported Event|AA Cohort Patients|Recurrent glioblastoma (GB) patients
406103|NCT00606008|E1|Reported Event|Sutent Treatment|"Sutent was administered daily for 4 weeks at a dose of 50 mg followed by a 2 week study drug free break.~Sunitinib Malate : Initially, patients were started on sunitinib at a dose of 50 mg daily. If 50 mg daily resulted in unacceptable toxicity, 2 dose modifications were allowed (to 37.5 and to 25 mg daily, if necessary). Study patients who could not tolerate 25 mg daily of sunitinib were taken off study."
406104|NCT00605917|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406105|NCT00605917|P1|Participant Flow|Sertraline|"Participants taking Sertraline according to Japanese Package Insert; This study is Special Investigation of JZOLOFT for panic disorder and one of conditions of this study is patients who are diagnosed with panic disorder. So, all of participants in this study are panic disorder patients."
406106|NCT00605917|O5|Outcome|Drank Alcohol Every Day|Participants who drank alcohol every day and who took Sertraline according to Japanese Package Insert
406107|NCT00605917|O4|Outcome|Drank Alcohol Moderately|Participants who drank alcohol moderately and who took Sertraline according to Japanese Package Insert
406108|NCT00605917|O3|Outcome|Used to Drink Alcohol But Did Not Then|Participants who used to drink alcohol but did not then and who took Sertraline according to Japanese Package Insert
406109|NCT00605917|O2|Outcome|Drank Alcohol Very Occasionally|Participants who drank alcohol very occasionally and who took Sertraline according to Japanese Package Insert
406110|NCT00605917|O1|Outcome|Didn’t Drink Alcohol at All, and Had Never Drunk Alcohol|Participants who didn’t drink alcohol at all, and had never drunk alcohol and who took Sertraline according to Japanese Package Insert
406111|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
406112|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
406113|NCT00605917|O2|Outcome|Without Concomitrant|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
406114|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
406115|NCT00605917|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
406116|NCT00605917|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
406117|NCT00605917|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
406118|NCT00605917|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
406119|NCT00605917|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
406120|NCT00605917|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
406121|NCT00605917|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
406245|NCT00605475|B10|Baseline|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
406123|NCT00605917|O1|Outcome|With History of Treatment|Participants with history of treatment prior to administration of Sertralin who took Sertraline according to Japanese Package Insert
406124|NCT00605917|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
406125|NCT00605917|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
406126|NCT00605917|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
406127|NCT00605917|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
406128|NCT00605917|O3|Outcome|Smoke Then|Participants who smoke then and who took Sertraline according to Japanese Package Insert
406129|NCT00605917|O2|Outcome|Used to Smoke But do Not Then|Participants who used to smoke but didn't then and who took Sertraline according to Japanese Package Insert
406130|NCT00605917|O1|Outcome|Don’t Smoke at All|Participants who didn't smoke at all and who took Sertraline according to Japanese Package Insert
406131|NCT00605917|O2|Outcome|Without Family History|Participants without family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
406132|NCT00605917|O1|Outcome|With Family History|Participants with family history of psychiatric disorders who took Sertraline according to Japanese Package Insert
406133|NCT00605917|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
406134|NCT00605917|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
406135|NCT00605917|O5|Outcome|Other Than Those Above|Participants whose starting dose were other than 25mg, 50mg, 75mg and 100mg
406136|NCT00605917|O4|Outcome|100mg|Participants whose starting dose were 100mg
406137|NCT00605917|O3|Outcome|75mg|Participants whose starting dose were 75mg
406138|NCT00605917|O2|Outcome|50mg|Participants whose starting dose were 50mg
406139|NCT00605917|O1|Outcome|25mg|Participants whose starting dose were 25mg
406140|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
406141|NCT00605917|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
406142|NCT00605917|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert.The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
406143|NCT00605904|B3|Baseline|Total|Total of all reporting groups
406144|NCT00605904|B2|Baseline|Placebo|Subjects received 3 tablets of placebo three times daily
406145|NCT00605904|B1|Baseline|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406146|NCT00605904|P2|Participant Flow|Placebo|Subjects received 3 tablets of placebo three times daily
406147|NCT00605904|P1|Participant Flow|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406148|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
406149|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406150|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
406151|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406152|NCT00605904|O2|Outcome|Placebo|Subjects received 3 tablets of placebo three times daily
406153|NCT00605904|O1|Outcome|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406154|NCT00605904|E2|Reported Event|Placebo|Subjects received 3 tablets of placebo three times daily
406155|NCT00605904|E1|Reported Event|Acamprosate|Subjects received 3 tablets of 333mg acamprosate three times daily
406156|NCT00605865|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406157|NCT00605865|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406158|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406159|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406160|NCT00605865|O4|Outcome|Over 65 Years of Age|Participants over 65 years of age who took Sertraline according to Japanese Package Insert
406161|NCT00605865|O3|Outcome|45-64 Years of Age|Participants from 45 to 64 years of age who took Sertraline according to Japanese Package Insert
406162|NCT00605865|O2|Outcome|18-44 Years of Age|Participants from 18 to 44 years of age who took Sertraline according to Japanese Package Insert
406163|NCT00605865|O1|Outcome|Under 18 Years of Age|Participants under 18 years of age who took Sertraline according to Japanese Package Insert
406164|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
406165|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
406166|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
406167|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
406168|NCT00605865|O2|Outcome|Outpatient|Participants as outpatients who took Sertraline according to Japanese Package Insert
406169|NCT00605865|O1|Outcome|Inpatient|Participants as inpatients who took Sertraline according to Japanese Package Insert
406170|NCT00605865|O2|Outcome|Without History of Treatment Prior to Sertraline|Participants without history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
406171|NCT00605865|O1|Outcome|With History of Treatment Prior to Sertraline|Participants with history of treatment prior to administration of Sertraline who took Sertraline according to Japanese Package Insert
406172|NCT00605865|O3|Outcome|Severe|Participants whose target disease are severe and who took Sertraline according to Japanese Package Insert
406173|NCT00605865|O2|Outcome|Moderate|Participants whose target disease are moderate and who took Sertraline according to Japanese Package Insert
406174|NCT00605865|O1|Outcome|Mild|Participants whose target disease are mild and who took Sertraline according to Japanese Package Insert
406175|NCT00605865|O2|Outcome|Under 15 Years|Participants under 15 years of age who took Sertraline according to Japanese Package Insert
406176|NCT00605865|O1|Outcome|15 Years and Higher|Participants 15 years and higher of age who took Sertraline according to Japanese Package Insert
406177|NCT00605865|O2|Outcome|Without Suicidal Ideation (Including Suicide Attempt)|Participants without suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406178|NCT00605865|O1|Outcome|With Suicidal Ideation (Including Suicide Attempt)|Participants with suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406179|NCT00605865|O5|Outcome|>=100mg|Participants who took more than 100mg of Sertraline a day on average according to Japanese Package Insert
406180|NCT00605865|O4|Outcome|>=75mg, <100mg|Participants who took more than 75mg and less than 100mg of Sertraline a day on average according to Japanese Package Insert
406181|NCT00605865|O3|Outcome|>=50mg, <75mg|Participants who took more than 50mg and less than 75mg of Sertraline a day on average according to Japanese Package Insert
406182|NCT00605865|O2|Outcome|>=25mg, <50mg|Participants who took more than 25mg and less than 50mg of Sertraline a day on average according to Japanese Package Insert
406183|NCT00605865|O1|Outcome|<25mg|Participants who took less than 25mg of Sertraline a day on average according to Japanese Package Insert
406184|NCT00605865|O2|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
406185|NCT00605865|O1|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
406186|NCT00605865|O2|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
406187|NCT00605865|O1|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
406188|NCT00605865|O2|Outcome|Without Concomitant Drug|Participants without concomitant drug who took Sertraline according to Japanese Package Insert
406189|NCT00605865|O1|Outcome|With Concomitant Drug|Participants with concomitant drug who took Sertraline according to Japanese Package Insert
406190|NCT00605865|O2|Outcome|Without Complications|Participants without complications who took Sertraline according to Japanese Package Insert
406191|NCT00605865|O1|Outcome|With Complications|Participants with complications who took Sertraline according to Japanese Package Insert
406192|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
406193|NCT00605865|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
406194|NCT00605865|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert. All observed or volunteered adverse events and the investigator’s opinion of the causal relationship to the study treatment were reported. Definition of an adverse event (AE) is any adverse change in health or side effect that occurs in participates. Treatment related Adverse Events were evaluated in company with the causal relationship to the investigational product.
406195|NCT00605839|B4|Baseline|Total|Total of all reporting groups
406196|NCT00605839|B3|Baseline|Usual Care|Usual care, without cell phone or glucopak
406197|NCT00605839|B2|Baseline|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
406198|NCT00605839|B1|Baseline|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
406199|NCT00605839|P3|Participant Flow|Usual Care|Usual care, without Glucopak or cell phones.
406200|NCT00605839|P2|Participant Flow|Cell Phone Only|Cell phone only. Participants are given cell phones and encouraged to keep in contact with the clinic.
406201|NCT00605839|P1|Participant Flow|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. Participants use the experimental device and are actively monitored by the clinic.
406202|NCT00605839|O3|Outcome|Usual Care|Usual care, without cell phone or glucopak
406203|NCT00605839|O2|Outcome|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
406204|NCT00605839|O1|Outcome|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
406205|NCT00605839|E3|Reported Event|Usual Care|Usual care, without cell phone or glucopak
406206|NCT00605839|E2|Reported Event|Cell Phone Only|Cell phone only, without the Glucopak. Participants will be given cell phones and encouraged to communicate more closely with the clinic, but will not use the Glucopak.
406207|NCT00605839|E1|Reported Event|Glucopak Cell Phone and Intensive Monitoring|Glucopak cell phone and intensive monitoring. This group will be given the experimental device, and placed in close communication with the clinic.
406208|NCT00605813|B1|Baseline|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406209|NCT00605813|P1|Participant Flow|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406210|NCT00605813|O2|Outcome|Present History of Intentional Suicidal Ideation|Participants with present intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406211|NCT00605813|O1|Outcome|Past History of Intentional Suicidal Ideation|Participants with past history of intentional suicidal ideation (including suicide attempt) who took Sertraline according to Japanese Package Insert
406405|NCT00605176|B4|Baseline|Total|Total of all reporting groups
406212|NCT00605813|O2|Outcome|Without Non-pharmaceutical Therapies|Participants without non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
406213|NCT00605813|O1|Outcome|With Non-pharmaceutical Therapies|Participants with non-pharmaceutical therapies who took Sertraline according to Japanese Package Insert
406214|NCT00605813|O2|Outcome|With Past Medical History of Other Illness|Participants with past medical history of other illness who took Sertraline according to Japanese Package Insert
406215|NCT00605813|O1|Outcome|Without Past Medical History of Other Illness|Participants without past medical history of other illness who took Sertraline according to Japanese Package Insert
406216|NCT00605813|O2|Outcome|With Renal Dysfunction|Participants with renal dysfunction who took Sertraline according to Japanese Package Insert
406217|NCT00605813|O1|Outcome|Without Renal Dysfunction|Participants without renal dysfunction who took Sertraline according to Japanese Package Insert
406218|NCT00605813|O1|Outcome|Sertraline|Participants who took Sertraline according to Japanese Package Insert
406219|NCT00605813|O1|Outcome|Sertraline Hydrochloride|Participants who took Sertraline according to Japanese Package Insert
406220|NCT00605813|E1|Reported Event|Sertraline|Participants taking Sertraline according to Japanese Package Insert
406221|NCT00605722|B1|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406222|NCT00605722|P1|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406223|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406224|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406225|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406226|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406227|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406228|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406229|NCT00605722|O1|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406230|NCT00605722|E1|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab (Avastin) 5 mg/kg intravenous (iv) on day 1 of each 2 week cycle plus erlotinib (Tarceva) 150 mg orally once a day until disease progression or unmanageable toxicity.
406231|NCT00605657|B1|Baseline|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
406232|NCT00605657|P1|Participant Flow|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
406233|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
406234|NCT00605657|O1|Outcome|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
406235|NCT00605657|E1|Reported Event|Valproic Acid|valproic acid administered starting at 10 mg/kg/day in divided doses twice daily x 3 days, increase to 15mg/kg/day x 3 days, increase to 20 mg/kg/day on day 7, increase to 30 mg/kg/day on day 14, maximum dose of 40mg/kg/day on day 21, if tolerated, to achieve plasma level 50-100 mcg/mL.
406236|NCT00605540|B1|Baseline|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406237|NCT00605540|P1|Participant Flow|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406238|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406239|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406240|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406241|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406242|NCT00605540|O1|Outcome|Chronic Obstructive Pulmonary Disease Markers Over Three Years|All patients were evaluated at baseline and attended at the clinics every six months for three years or until death.
406243|NCT00605540|E1|Reported Event|Chronic Obstructive Pulmonary Disease|
406247|NCT00605475|B8|Baseline|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
406248|NCT00605475|B7|Baseline|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406249|NCT00605475|B6|Baseline|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406250|NCT00605475|B5|Baseline|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406251|NCT00605475|B4|Baseline|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
406252|NCT00605475|B3|Baseline|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406253|NCT00605475|B2|Baseline|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
406254|NCT00605475|B1|Baseline|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
406255|NCT00605475|P10|Participant Flow|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
406256|NCT00605475|P9|Participant Flow|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406257|NCT00605475|P8|Participant Flow|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
406258|NCT00605475|P7|Participant Flow|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406259|NCT00605475|P6|Participant Flow|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406260|NCT00605475|P5|Participant Flow|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406261|NCT00605475|P4|Participant Flow|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
406262|NCT00605475|P3|Participant Flow|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406263|NCT00605475|P2|Participant Flow|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
406264|NCT00605475|P1|Participant Flow|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
406265|NCT00605475|O10|Outcome|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
406266|NCT00605475|O9|Outcome|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406267|NCT00605475|O8|Outcome|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
406268|NCT00605475|O7|Outcome|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406269|NCT00605475|O6|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406270|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406271|NCT00605475|O4|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
406272|NCT00605475|O3|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406273|NCT00605475|O2|Outcome|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
406274|NCT00605475|O1|Outcome|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
406275|NCT00605475|O7|Outcome|Cohort 4: Anakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406276|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) : Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
406277|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406278|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406279|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406280|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406281|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406282|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406283|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
406284|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406285|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406286|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406287|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406288|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406289|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406290|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406291|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406292|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
406293|NCT00605475|O5|Outcome|Cohort 3:Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406294|NCT00605475|O4|Outcome|Cohort 3:Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406295|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406296|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406297|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406298|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406299|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
406300|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406301|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406302|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406303|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406304|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406305|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406306|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo of cohort 3 and 4. Single dose IV infusion of Placebo
406307|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406308|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406309|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406310|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406311|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406312|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406313|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
406314|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406315|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406316|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406317|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406318|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406319|NCT00605475|O7|Outcome|Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406320|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
406321|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406322|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406323|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406324|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406325|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406326|NCT00605475|O7|Outcome|Cohort 4:Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406327|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
406328|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406329|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406330|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406331|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406332|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406333|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406334|NCT00605475|O6|Outcome|Pooled (Cohort 3and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
406335|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406336|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406337|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406338|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406339|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406340|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406341|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4) Placebo Infusion|Pooled placebo from cohort 3 and 4. Single dose IV infusion of Placebo
406342|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406343|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406344|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406345|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406346|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406347|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406348|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from cohort 3 and 4. ingle dose IV infusion of Placebo
406349|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406350|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406351|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406352|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406612|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
406353|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406354|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406355|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled placebo from Cohort 3 and 4. Single dose IV infusion of Placebo
406356|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406357|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406358|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406359|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406360|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406361|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406362|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
406363|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406364|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406365|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406366|NCT00605475|O2|Outcome|Cohort 2:Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406367|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406368|NCT00605475|O7|Outcome|Cohort 4: Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406369|NCT00605475|O6|Outcome|Pooled (Cohort 3 and 4): Placebo Infusion|Pooled Placebo of Cohort 3 and 4. Single dose IV infusion of Placebo
406370|NCT00605475|O5|Outcome|Cohort 3: Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406371|NCT00605475|O4|Outcome|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406372|NCT00605475|O3|Outcome|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406373|NCT00605475|O2|Outcome|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406374|NCT00605475|O1|Outcome|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406375|NCT00605475|E10|Reported Event|Cohort 4: Placebo to Canakinumab 0.03 mg/kg|Single dose IV injection of Placebo to Canakinumab 0.03 mg/kg
406376|NCT00605475|E9|Reported Event|Cohort 4 : Canakinumab Injection 0.03 mg/kg|Single dose IV injection of Canakinumab 0.03 mg/kg
406377|NCT00605475|E8|Reported Event|Cohort 3: Placebo Infusion|Single dose IV infusion of Placebo
406378|NCT00605475|E7|Reported Event|Cohort 3 : Canakinumab Infusion 1.5 mg/kg|Single dose IV infusion of canakinumab 1.5 mg/kg
406379|NCT00605475|E6|Reported Event|Cohort 3: Canakinumab Infusion 0.3 mg/kg|Single dose IV infusion of Canakinumab 0.3 mg/kg
406380|NCT00605475|E5|Reported Event|Cohort 3: Canakinumab Infusion 0.1 mg/kg|Single dose IV infusion Canakinumab 0.1 mg/kg
406381|NCT00605475|E4|Reported Event|Cohort 2: Placebo to Canakinumab 10 mg/kg|Single dose IV infusion of Placebo to Canakinumab 10 mg/kg
406382|NCT00605475|E3|Reported Event|Cohort 2: Canakinumab Infusion 10 mg/kg|Single dose IV infusion of Canakinumab 10 mg/kg
406383|NCT00605475|E2|Reported Event|Cohort 1: Placebo to Canakinumab 0.3 mg/kg|Single dose IV infusion of placebo to Canakinumab 0.3 mg/kg
406384|NCT00605475|E1|Reported Event|Cohort 1: Canakinumab Infusion 0.3 mg/kg|Single dose intravenous (IV) infusion of canakinumab 0.3 mg/kg
406385|NCT00605423|B3|Baseline|Total|Total of all reporting groups
406386|NCT00605423|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
406387|NCT00605423|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
406388|NCT00605423|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
406389|NCT00605423|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
406390|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
406391|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
406392|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
406393|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
406394|NCT00605423|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
406395|NCT00605423|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
406396|NCT00605423|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|"Dose 0.5 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.5 ug/day implant"
406397|NCT00605423|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|"Dose 0.2 ug/day Medidur implant~Fluocinolone Acetonide/Medidur : 0.2 ug/day implant"
406398|NCT00605202|B1|Baseline|Entire Study Population|
406399|NCT00605202|P2|Participant Flow|Licorice and HCTZ First, Then Licorice|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the first intervention period, then licorice 32 grams a day in the second intervention period.
406400|NCT00605202|P1|Participant Flow|Licorice First, Then Licorice and HCTZ|Licorice 32 grams a day in the first intervention period, then licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily in the second intervention period.
406401|NCT00605202|O2|Outcome|Licorice and HCTZ|
406402|NCT00605202|O1|Outcome|Licorice|
406403|NCT00605202|E2|Reported Event|Licorice and HCTZ|Licorice 32 grams a day together with Hydrochlorothiazide 25 mg once daily
406406|NCT00605176|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406407|NCT00605176|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406408|NCT00605176|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406409|NCT00605176|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406410|NCT00605176|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406411|NCT00605176|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406412|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406413|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406414|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406415|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406416|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406417|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406418|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406419|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406420|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406421|NCT00605176|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406422|NCT00605176|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406423|NCT00605176|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406424|NCT00605176|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406425|NCT00605176|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406426|NCT00605176|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment.
406427|NCT00605150|B1|Baseline|TheraSphere Treatment|Total number of patients enrolled, TheraSphere treatment
406428|NCT00605150|P1|Participant Flow|Treatment|TheraSphere, TheraSphere-Yttrium 90 microsphere, treatment for patients with unresectable HCC
406429|NCT00605150|O1|Outcome|TheraSphere Treatment|Total number of patients enrolled TheraSphere treatment for patients with unresectable HCC
406430|NCT00605150|E1|Reported Event|TheraSphere Treatment for Patients With Unresectable HCC|Total number of patients enrolled, TheraSphere treatment for patients with unresectable HCC
406431|NCT00605085|B3|Baseline|Total|Total of all reporting groups
406432|NCT00605085|B2|Baseline|Placebo|Placebo
406433|NCT00605085|B1|Baseline|IC51|IC51
406434|NCT00605085|P2|Participant Flow|Placebo|Placebo
406435|NCT00605085|P1|Participant Flow|IC51|IC51
406436|NCT00605085|O2|Outcome|Placebo|Placebo
406437|NCT00605085|O1|Outcome|IC51|IC51
406438|NCT00605085|E2|Reported Event|Placebo|Placebo
406439|NCT00605085|E1|Reported Event|IC51|IC51
406440|NCT00605072|B4|Baseline|Total|Total of all reporting groups
406441|NCT00605072|B3|Baseline|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406442|NCT00605072|B2|Baseline|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406443|NCT00605072|B1|Baseline|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406444|NCT00605072|P3|Participant Flow|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406445|NCT00605072|P2|Participant Flow|Candesartan|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406446|NCT00605072|P1|Participant Flow|Lisinopril|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406447|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406448|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406449|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406450|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406451|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406452|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406471|NCT00605033|O1|Outcome|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
415932|NCT00577135|B5|Baseline|Total|Total of all reporting groups
406453|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406454|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406455|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406456|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406457|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406458|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406459|NCT00605072|O3|Outcome|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406460|NCT00605072|O2|Outcome|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406461|NCT00605072|O1|Outcome|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406462|NCT00605072|E3|Reported Event|HCTZ|"hydrochlorothiazide : orally 12.5 mg increased to 25 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406463|NCT00605072|E2|Reported Event|ARB (Candesartan)|"Angiotensin Receptor Blocker: candesartan : orally 8 mg increased to 16 mg then 32 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406464|NCT00605072|E1|Reported Event|ACEI (Lisinopril)|"Angiotensin-Converting Enzyme (ACE) Inhibitor: lisinopril : orally 10 mg increased to 20 mg then 40 mg to achieve target blood pressure of 140/90, then daily for 12 months~nifedipine, long acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 30 mg increased to 60 mg and 90 mg in 2 week increments~metoprolol, long-acting : If needed to achieve target blood pressure of 140/90, added to ARB or ACEI at 12.5 mg increased to 25 mg and 50 mg"
406465|NCT00605033|B3|Baseline|Total|Total of all reporting groups
406466|NCT00605033|B2|Baseline|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406467|NCT00605033|B1|Baseline|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406468|NCT00605033|P2|Participant Flow|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406469|NCT00605033|P1|Participant Flow|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406470|NCT00605033|O2|Outcome|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406472|NCT00605033|E2|Reported Event|Subutex|Double-blind, once-daily sublingual Subutex (buprenorphine 4 mg to 24 mg) plus matching Suboxone placebo during Week 1 followed by open-label, once-daily sublingual Subutex during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406473|NCT00605033|E1|Reported Event|Suboxone|Double-blind, once-daily sublingual Suboxone (buprenorphine/naloxone 4 mg/1 mg to 24 mg/6 mg) plus matching Subutex placebo during Week 1 followed by open-label, once-daily sublingual Suboxone during Weeks 2-4 with weekly access to take-home doses as of Week 2.
406474|NCT00604968|B1|Baseline|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406475|NCT00604968|P1|Participant Flow|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406476|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406477|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406478|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406479|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406480|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406481|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406482|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406483|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406484|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406485|NCT00604968|O1|Outcome|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406486|NCT00604968|E1|Reported Event|Caelyx|Caelyx was administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug was diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
406487|NCT00604851|B3|Baseline|Total|Total of all reporting groups
406488|NCT00604851|B2|Baseline|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
406489|NCT00604851|B1|Baseline|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
406490|NCT00604851|P2|Participant Flow|Placebo|placebo medication, taken by mouth once daily
406491|NCT00604851|P1|Participant Flow|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg taken by mouth once daily, participants >= 30 kg: 30 mg taken by mouth once daily
406492|NCT00604851|O2|Outcome|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
406493|NCT00604851|O1|Outcome|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
406494|NCT00604851|E2|Reported Event|Placebo|placebo : participants < 30 kg: 15 mg po once daily participants <= 30 kg: 30 mg po once daily
406495|NCT00604851|E1|Reported Event|Lansoprazole|lansoprazole : participants < 30 kg: 15 mg po once daily
406496|NCT00604812|B4|Baseline|Total|Total of all reporting groups
406497|NCT00604812|B3|Baseline|Panel C|Includes the participants who received 5 mg rizatriptan (n=1), 10 mg rizatriptan (n=4), and the matching placebo (n=1)
406498|NCT00604812|B2|Baseline|Panel B|Includes the participants from the 10 mg rizatriptan group (10) and the matching placebo group (3)
406499|NCT00604812|B1|Baseline|Panel A|Includes the participants from the 5 mg rizatriptan group (9) and the matching placebo group (3)
406500|NCT00604812|P6|Participant Flow|Panel C Placebo|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT placebo on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg placebo dose and subjects weighing 40 kg and above received a 10 mg placebo dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406501|NCT00604812|P5|Participant Flow|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406502|NCT00604812|P4|Participant Flow|Panel B Placebo|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406613|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
406503|NCT00604812|P3|Participant Flow|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406504|NCT00604812|P2|Participant Flow|Panel A Placebo|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) placebo on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406505|NCT00604812|P1|Participant Flow|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406506|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406507|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406508|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406509|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406510|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406511|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406512|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406513|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406514|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406515|NCT00604812|O3|Outcome|Panel C Rizatriptan|"Subjects allocated to Panel C and randomized to receive a single dose of rizatriptan ODT on Day 1. Subjects in Panel C weighing 20-39 kg received a 5 mg dose and subjects weighing 40 kg and above received a 10 mg dose.~Panel C was added to the study by amendment to increase the number of male subjects in the 12-17 year old age group."
406516|NCT00604812|O2|Outcome|Panel B Rizatriptan|"Subjects allocated to Panel B and randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 40 kg and above were allocated to Panel B."
406517|NCT00604812|O1|Outcome|Panel A Rizatriptan|"Subjects allocated to Panel A and randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.~Subjects weighing 20-39 kg were allocated to Panel A."
406518|NCT00604812|O3|Outcome|Placebo|Combined Placebo groups from panels A, B, and C.
406519|NCT00604812|O2|Outcome|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
406520|NCT00604812|O1|Outcome|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
406521|NCT00604812|E3|Reported Event|Placebo|Combined Placebo groups from panels A, B, and C.
406522|NCT00604812|E2|Reported Event|Rizatriptan 10 mg|Combined subjects from Panel B and Panel C randomized to receive a single dose of rizatriptan 10 mg orally disintegrating tablet (ODT) on Day 1.
406523|NCT00604812|E1|Reported Event|Rizatriptan 5 mg|Combined subjects from Panel A and Panel C randomized to receive a single dose of rizatriptan 5 mg orally disintegrating tablet (ODT) on Day 1.
406524|NCT00604721|B1|Baseline|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
406525|NCT00604721|P1|Participant Flow|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
406526|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
406578|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
415933|NCT00577135|B4|Baseline|Continuous Infusion & High Intensification|
406527|NCT00604721|O1|Outcome|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
406528|NCT00604721|O1|Outcome|Safety Cohort: AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was determined by the algorithm presented in the safety cohort."
406529|NCT00604721|E1|Reported Event|AZD6244 Treatment|"The first 6 patients with moderate liver dysfunction (Child's B or total bilirubin 1.5-2x ULN) were to comprise a moderate liver dysfunction safety cohort. AZD6244 was administered at a dose of 100 mg twice daily (48 hours after initial single dose for PK), approximately 12 hours apart, in a mix and drink formulation. For the purposes of evaluation, a cycle was defined as 21 days. Dosing for the remainder of patients (efficacy cohort) was to be determined by the algorithm presented in the safety cohort."
406530|NCT00604708|B3|Baseline|Total|Total of all reporting groups
406531|NCT00604708|B2|Baseline|JE-VAX|JE-VAX
406532|NCT00604708|B1|Baseline|IC51|IC51
406533|NCT00604708|P2|Participant Flow|JE-VAX|JE-VAX
406534|NCT00604708|P1|Participant Flow|IC51|IC51
406535|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
406536|NCT00604708|O1|Outcome|IC51|IC51
406537|NCT00604708|O2|Outcome|JE-VAX|JE-VAX
406538|NCT00604708|O1|Outcome|IC51|IC51
406539|NCT00604708|E2|Reported Event|JE-VAX|JE-VAX
406540|NCT00604708|E1|Reported Event|IC51|IC51
406541|NCT00604695|B3|Baseline|Total|Total of all reporting groups
406542|NCT00604695|B2|Baseline|Placebo Control|Two (4mL) doses of sterile saline
406543|NCT00604695|B1|Baseline|Active Treatment|Two (4mg) doses of tenecteplase
406544|NCT00604695|P2|Participant Flow|Placebo Control|Two (4mL) doses of sterile saline
406545|NCT00604695|P1|Participant Flow|Active Treatment|Two (4mg) doses of tenecteplase
406546|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406547|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406548|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406549|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406550|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406551|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406552|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406553|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406554|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406555|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406556|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406557|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406558|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406559|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406560|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406561|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406562|NCT00604695|O2|Outcome|Placebo Control|Two (4mL) doses of sterile saline
406563|NCT00604695|O1|Outcome|Active Treatment|Two (4mg) doses of tenecteplase
406564|NCT00604695|E2|Reported Event|Placebo Control|Two (4mL) doses of sterile saline
406565|NCT00604695|E1|Reported Event|Active Treatment|Two (4mg) doses of tenecteplase
406566|NCT00604669|B1|Baseline|Those Exposed to TPN|
406567|NCT00604669|P1|Participant Flow|Those Exposed to TPN|
406568|NCT00604669|O1|Outcome|Those Exposed to TPN|
406569|NCT00604669|E1|Reported Event|Those Exposed to TPN|
406570|NCT00604565|B3|Baseline|Total|Total of all reporting groups
406571|NCT00604565|B2|Baseline|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
406572|NCT00604565|B1|Baseline|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
406573|NCT00604565|P2|Participant Flow|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
406574|NCT00604565|P1|Participant Flow|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
406575|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
406576|NCT00604565|O1|Outcome|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
406577|NCT00604565|O2|Outcome|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
415934|NCT00577135|B3|Baseline|Continuous Infusion & Low Intensification|
406579|NCT00604565|E2|Reported Event|Standard Dialysate|"standard dialysate without soluble ferric pyrophosphate (SFP)~placebo: Subjects will be randomized to undergo dialysis with C-HD (conventional dialysate lacking SFP)"
406580|NCT00604565|E1|Reported Event|SFP Dialysate|"dialysate with added soluble ferric pyrophosphate (SFP)~soluble ferric pyrophosphate (SFP): Subjects will be randomized to undergo dialysis with Fe-HD (dialysate containing SFP) The experimental concentrate containing SFP (Fe-HD)has 95mg of SFP per gallon, or 10.9 mg total iron per gallon (96 µg of SFP per dL or 11 µg of total iron per dL)."
406581|NCT00604552|B3|Baseline|Total|Total of all reporting groups
406582|NCT00604552|B2|Baseline|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
406583|NCT00604552|B1|Baseline|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
406584|NCT00604552|P2|Participant Flow|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
406585|NCT00604552|P1|Participant Flow|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
406586|NCT00604552|O2|Outcome|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
406587|NCT00604552|O1|Outcome|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
406588|NCT00604552|E2|Reported Event|PS Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic
406589|NCT00604552|E1|Reported Event|Lifeline Registry|All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS)
406590|NCT00604500|B1|Baseline|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406591|NCT00604500|P1|Participant Flow|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406592|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406593|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406594|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406595|NCT00604500|O1|Outcome|MF/F MDI 100/10 mcg BID (With Dose Counter)|MF/F MDI 100/10 mcg BID with an integrated dose counter (administered as two inhalations of 50/5 mcg, twice a day) over a 4-week Treatment Period.
406596|NCT00604500|E1|Reported Event|MF/F MDI 100/10 mcg BID|Included all participants that received 100/10 mcg BID (with and without dose counter)
406597|NCT00604461|B1|Baseline|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
406598|NCT00604461|P1|Participant Flow|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
406599|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
406600|NCT00604461|O1|Outcome|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
406601|NCT00604461|E1|Reported Event|Dose Escalation Followed by Maintenance Therapy|"A: Tiered Dose Escalation/Phase II Dose. Tier -1: Carboplatin AUC 4 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 1: Carboplatin AUC 5 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2. Tier 2: Carboplatin AUC 6 + Bevacizumab 15 mg/Kg+Pemetrexed 500 mg/m^2.~B: Maintenance Therapy - Patient was maintained on pemetrexed plus bevacizumab for a total of one year after initiation of maintenance or until progression which ever occured first."
406602|NCT00604383|B3|Baseline|Total|Total of all reporting groups
406603|NCT00604383|B2|Baseline|Placebo|1 tablet, orally, daily, for up to 42 months
406604|NCT00604383|B1|Baseline|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
406605|NCT00604383|P2|Participant Flow|Placebo|1 tablet, orally, daily, for up to 42 months
406606|NCT00604383|P1|Participant Flow|Ruboxistaurin|One 32-milligram (mg) tablet, orally, daily, for up to 42 months
406607|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
406608|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
406609|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
406610|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
406611|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
415935|NCT00577135|B2|Baseline|Q12 Hours Bolus & High Intensification|
406614|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
406615|NCT00604383|O2|Outcome|Placebo|1 tablet, orally, daily, for 36 months
406616|NCT00604383|O1|Outcome|Ruboxistaurin|One 32-mg tablet, orally, daily, for 36 months
406617|NCT00604383|E2|Reported Event|Placebo|1 tablet, orally, daily, for up to 42 months
406618|NCT00604383|E1|Reported Event|Ruboxistaurin|One 32-mg tablet, orally, daily, for up to 42 months
406619|NCT00604279|B3|Baseline|Total|Total of all reporting groups
406620|NCT00604279|B2|Baseline|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406621|NCT00604279|B1|Baseline|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406622|NCT00604279|P2|Participant Flow|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406623|NCT00604279|P1|Participant Flow|Paliperidone Palmitate|Paliperidone palmitate (R092670) suspension for intramuscular (directly into a muscle) injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406624|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406625|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406626|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406627|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406628|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406629|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406630|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406631|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406632|NCT00604279|O2|Outcome|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406633|NCT00604279|O1|Outcome|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406634|NCT00604279|E2|Reported Event|Risperidone Long Acting Injection (LAI)|Risperidone LAI intramuscular at a dose of 25 milligram (mg) on Day 8 and Day 22; flexible dose of either 25 or 37.5 mg on Day 36 with same dose on Day 50; and either 25, 37.5, or 50 mg on Day 64 with same dose on Day 78; along with oral risperidone 2 mg tablet on Day 1, flexible doses (1-6 mg/day) for first 28 days; and 1-2 mg/day during Day 36-57 and Day 64-85 if the dose of risperidone LAI was increased on Day 36 and Day 64.
406635|NCT00604279|E1|Reported Event|Paliperidone Palmitate|Paliperidone palmitate suspension for intramuscular injection at a dose of 150 milligram equivalent (mg eq.) at baseline, 100 mg eq. on Day 8, flexible dose, either 50 or 100 mg eq on Day 36 and 50, 100, or 150 mg eq. on Day 64 depending on investigator’s discretion.
406636|NCT00604214|B3|Baseline|Total|Total of all reporting groups
406637|NCT00604214|B2|Baseline|Placebo|0.9% sodium chloride, intravenous, 96 hours
415936|NCT00577135|B1|Baseline|Q12 Hours Bolus & Low Intensification|
406638|NCT00604214|B1|Baseline|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406639|NCT00604214|P2|Participant Flow|Placebo|0.9% sodium chloride, intravenous, 96 hours
406640|NCT00604214|P1|Participant Flow|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406641|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406642|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406643|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406644|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406645|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406646|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406647|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406648|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406649|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406650|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406651|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406652|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406653|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406654|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406655|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406656|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406657|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406658|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406659|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406660|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406661|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406662|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406663|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406664|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406665|NCT00604214|O2|Outcome|Placebo|0.9% sodium chloride, intravenous, 96 hours
406666|NCT00604214|O1|Outcome|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406667|NCT00604214|E2|Reported Event|Placebo|0.9% sodium chloride, intravenous, 96 hours
406668|NCT00604214|E1|Reported Event|Drotrecogin Alfa (Activated)|24 microgram/kilogram/hour, intravenous, 96 hours
406669|NCT00604188|B3|Baseline|Total|Total of all reporting groups
406670|NCT00604188|B2|Baseline|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406671|NCT00604188|B1|Baseline|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406672|NCT00604188|P2|Participant Flow|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406673|NCT00604188|P1|Participant Flow|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406674|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406675|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406676|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406677|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406678|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406679|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406680|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406713|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV18 at baseline.
416036|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
406681|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406682|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406683|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406684|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406685|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406686|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406687|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406688|NCT00604188|O2|Outcome|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406689|NCT00604188|O1|Outcome|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406690|NCT00604188|E2|Reported Event|Subutex-to-Suboxone Induction|Participants received 8 mg Subutex and placebo Suboxone on Day 1, 16 mg Subutex and placebo Suboxone on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406691|NCT00604188|E1|Reported Event|Direct Suboxone Induction|Participants received 8 mg of Suboxone and placebo Subutex on Day 1, 16 mg of Suboxone and placebo Subutex on Day 2, and all participants received open label Suboxone from Day 3 to Day 28. Suboxone dosage may be titrated from Day 4 to Day 28 up to 24 mg per day.
406692|NCT00604175|B4|Baseline|Total|Total of all reporting groups
406693|NCT00604175|B3|Baseline|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406694|NCT00604175|B2|Baseline|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406695|NCT00604175|B1|Baseline|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406696|NCT00604175|P3|Participant Flow|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406697|NCT00604175|P2|Participant Flow|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406698|NCT00604175|P1|Participant Flow|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406699|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406700|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406701|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406702|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406703|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406704|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406705|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406706|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406707|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406708|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406709|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406710|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406711|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV18 at baseline.
406712|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV18 at baseline.
406714|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV16 at baseline.
406715|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV16 at baseline.
406716|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV16 at baseline.
406717|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV11 at baseline.
406718|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV11 at baseline.
406719|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV11 at baseline.
406720|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6+|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seropositive for HPV6 at baseline.
406721|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6+|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seropositive for HPV6 at baseline.
406722|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6+|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seropositive for HPV6 at baseline.
406723|NCT00604175|O3|Outcome|Stratum C/Baseline HPV18-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV18 at baseline.
406724|NCT00604175|O2|Outcome|Stratum B/Baseline HPV18-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV18 at baseline.
406725|NCT00604175|O1|Outcome|Stratum A/Baseline HPV18-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV18 at baseline.
406726|NCT00604175|O3|Outcome|Stratum C/Baseline HPV16-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV16 at baseline.
406727|NCT00604175|O2|Outcome|Stratum B/Baseline HPV16-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV16 at baseline.
406728|NCT00604175|O1|Outcome|Stratum A/Baseline HPV16-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV16 at baseline.
406729|NCT00604175|O3|Outcome|Stratum C/Baseline HPV11-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV11 at baseline.
406730|NCT00604175|O2|Outcome|Stratum B/Baseline HPV11-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV11 at baseline.
406731|NCT00604175|O1|Outcome|Stratum A/Baseline HPV11-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV11 at baseline.
406732|NCT00604175|O3|Outcome|Stratum C/Baseline HPV6-|Participants with screening CD4+ count<=200 cells/mm^3 (Stratum C) who were seronegative for HPV6 at baseline.
406733|NCT00604175|O2|Outcome|Stratum B/Baseline HPV6-|Participants with screening CD4+ count >200 to <=350 cells/mm^3 (Stratum B) who were seronegative for HPV6 at baseline.
406734|NCT00604175|O1|Outcome|Stratum A/Baseline HPV6-|Participants with screening CD4+ count >350 cells/mm^3 (Stratum A) who were seronegative for HPV6 at baseline.
406735|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406736|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406737|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406738|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406739|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406740|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406741|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406742|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406743|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406744|NCT00604175|O3|Outcome|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406745|NCT00604175|O2|Outcome|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406746|NCT00604175|O1|Outcome|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406747|NCT00604175|E3|Reported Event|Stratum C|Participants with screening CD4 count <=200 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406748|NCT00604175|E2|Reported Event|Stratum B|Participants with screening CD4 count >200 to <=350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406749|NCT00604175|E1|Reported Event|Stratum A|Participants with screening CD4 count >350 cells/mm^3 received 0.5mL of quadrivalent HPV vaccine at baseline and Weeks 8 and 24.
406750|NCT00604162|B1|Baseline|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
406751|NCT00604162|P1|Participant Flow|Colon Capsule Endoscopy, Then Standard Colonoscopy|"Capsule endoscopy was ingested following colon preparation without colon insufflation or sedation.The purpose was to detect patients with polyps equal or larger than 6mm. Patients subsequently had standard colonoscopy as gold standard comparison."
407943|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
406752|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
406753|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
406754|NCT00604162|O1|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
406755|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
406756|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
406757|NCT00604162|O2|Outcome|Standard Colonoscopy|"After bowel preparation and capsule endoscopy, patients subsequently had standard colonoscopy as gold standard comparison (with colon insufflation and sedation)."
406758|NCT00604162|O1|Outcome|PillCam COLON|Ingestible capsule equipped with an endoscope with two imagers, given after bowel preparation and before standard colonoscopy.
406759|NCT00604162|E2|Reported Event|Adverse Events Related to the Capsule|AE related to the capsule endoscopy procedure
406760|NCT00604162|E1|Reported Event|Adverse Events Related to Colonoscopy|AE related to colonoscopy procedure
406761|NCT00604045|B3|Baseline|Total|Total of all reporting groups
406762|NCT00604045|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
406763|NCT00604045|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
406764|NCT00604045|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
406765|NCT00604045|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
406766|NCT00604045|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
406767|NCT00604045|O1|Outcome|1 Attention Bias Modification (ABM)|"The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.~be."
406768|NCT00604045|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
406769|NCT00604045|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
406770|NCT00604019|B3|Baseline|Total|Total of all reporting groups
406771|NCT00604019|B2|Baseline|Norepinephrine|Patients that get NE infusion
406772|NCT00604019|B1|Baseline|Dopamine|Patients that get DA infusion
406773|NCT00604019|P2|Participant Flow|Norepinephrine|Norepinephrine infusion via central catheter
406774|NCT00604019|P1|Participant Flow|Dopamine|Dopaime infusion via central catheter
406775|NCT00604019|O2|Outcome|Norepinephrine|Patients getting NE infusion
406776|NCT00604019|O1|Outcome|Dopamine|Patients getting DA infusion
406777|NCT00604019|E2|Reported Event|Norepinephrine|Patients that get NE infusion
406778|NCT00604019|E1|Reported Event|Dopamine|Patients that get DA infusion
406779|NCT00603993|B1|Baseline|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406780|NCT00603993|P1|Participant Flow|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406781|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406782|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406783|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406784|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406785|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406786|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406787|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406788|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406789|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406790|NCT00603993|O1|Outcome|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406791|NCT00603993|E1|Reported Event|Adalimumab 40 mg or 80 mg Every Other Week (Eow)|Adalimumab 40 mg or 80 mg (same dose subject was receiving in preceding Study M03-651 [NCT00235872]) subcutaneously (sc) eow until approval of adalimumab in Japan
406792|NCT00603915|B1|Baseline|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
406793|NCT00603915|P1|Participant Flow|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
406794|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
406795|NCT00603915|O1|Outcome|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
406796|NCT00603915|E1|Reported Event|GEMCITABINE AND CISPLATIN/CARBOPLATIN (GC) PLUS ERLOTINIB|patients with recurrent and/or metastatic NPC will be treated with 6 cycles of GC followed by maintenance erlotinib (150mg by mouth daily) for 6 cycles.
406797|NCT00603902|B4|Baseline|Total|Total of all reporting groups
406798|NCT00603902|B3|Baseline|Matching Placebo|matching placebo tablets
406799|NCT00603902|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
406800|NCT00603902|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
406801|NCT00603902|P3|Participant Flow|Matching Placebo|matching placebo tablets
406802|NCT00603902|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
406803|NCT00603902|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
406804|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
406805|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
406806|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
406807|NCT00603902|O3|Outcome|Matching Placebo|matching placebo tablets
406808|NCT00603902|O2|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
406809|NCT00603902|O1|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
406810|NCT00603902|E3|Reported Event|Matching Placebo|matching placebo tablets
406811|NCT00603902|E2|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
406812|NCT00603902|E1|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
406813|NCT00603889|B1|Baseline|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
406814|NCT00603889|P1|Participant Flow|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
406815|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
406816|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
406817|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
406818|NCT00603889|O1|Outcome|Na-ASP-2 Hookworm Antigen Skin Test|"Application of different concentrations of the Na-ASP-2 antigen skin test reagent as prick-puncture (scratch test) and intradermal injections, applied to participants' forearms."
406819|NCT00603889|E1|Reported Event|Na-ASP-2 Hookworm Antigen Skin Test|All participants will have the same number of concentrations of the Na-ASP-2 skin test reagent applied to their arms, using both the prick-puncture and intradermal techniques.
406820|NCT00603837|B3|Baseline|Total|Total of all reporting groups
406821|NCT00603837|B2|Baseline|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
406822|NCT00603837|B1|Baseline|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
406823|NCT00603837|P2|Participant Flow|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
406824|NCT00603837|P1|Participant Flow|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
406825|NCT00603837|O2|Outcome|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
406826|NCT00603837|O1|Outcome|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
406827|NCT00603837|E2|Reported Event|Wrap|This arm includes those ELGANs randomized to be wrapped in polyethylene after delivery.
406828|NCT00603837|E1|Reported Event|Blanket|This arm includes those ELGANs who are to be placed on a sodium acetate warming blanket after delivery.
406829|NCT00603798|B4|Baseline|Total|Total of all reporting groups
406830|NCT00603798|B3|Baseline|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406831|NCT00603798|B2|Baseline|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406832|NCT00603798|B1|Baseline|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406833|NCT00603798|P3|Participant Flow|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406834|NCT00603798|P2|Participant Flow|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406835|NCT00603798|P1|Participant Flow|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406836|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406837|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406838|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406839|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406840|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406841|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406842|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406843|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406844|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406845|NCT00603798|O3|Outcome|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406846|NCT00603798|O2|Outcome|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406847|NCT00603798|O1|Outcome|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406848|NCT00603798|E3|Reported Event|Placebo Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406849|NCT00603798|E2|Reported Event|2.5% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406850|NCT00603798|E1|Reported Event|3.75% Imiquimod Cream|250 mg/packet, up to 2 packets applied daily for 2 treatment cycles. The first treatment cycle consisted of 3 weeks of daily treatment followed by 3 weeks of no treatment, and the second treatment cycle consisted of an additional 3 weeks of daily treatment followed by 8 weeks of no treatment.
406851|NCT00603746|B7|Baseline|Total|Total of all reporting groups
406852|NCT00603746|B6|Baseline|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406853|NCT00603746|B5|Baseline|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406854|NCT00603746|B4|Baseline|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406855|NCT00603746|B3|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406856|NCT00603746|B2|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406857|NCT00603746|B1|Baseline|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406858|NCT00603746|P6|Participant Flow|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the
406859|NCT00603746|P5|Participant Flow|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406860|NCT00603746|P4|Participant Flow|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406861|NCT00603746|P3|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406862|NCT00603746|P2|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406863|NCT00603746|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406864|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406865|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406866|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406867|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406868|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406869|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406870|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406871|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406872|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406873|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406874|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406875|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406876|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406877|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406878|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406879|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406880|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406881|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406882|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406883|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406884|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406885|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406886|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406887|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406888|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406889|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406890|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406891|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406892|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406893|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406894|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406895|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406896|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406897|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406898|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406899|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406900|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406901|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406902|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406903|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406904|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407024|NCT00603642|P2|Participant Flow|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407025|NCT00603642|P1|Participant Flow|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
416037|NCT00577135|O4|Outcome|High Intensification|
406905|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406906|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406907|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406908|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406909|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406910|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406911|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406912|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406913|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406914|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406915|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406916|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406917|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406918|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406919|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406920|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406921|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406922|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407026|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407027|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407944|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
406923|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406924|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406925|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406926|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406927|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406928|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406929|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406930|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406931|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406932|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406933|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406934|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406935|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406936|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406937|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406938|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406939|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406940|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407028|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407029|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407945|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
406941|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406942|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406943|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406944|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406945|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406946|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406947|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406948|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406949|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406950|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406951|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406952|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406953|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406954|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406955|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406956|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406957|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406958|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407030|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407031|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407946|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
406959|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406960|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406961|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406962|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406963|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406964|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406965|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406966|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406967|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406968|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406969|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406970|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406971|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406972|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406973|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406974|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406975|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406976|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407032|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407033|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407947|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
406977|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406978|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406979|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406980|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406981|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406982|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406983|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406984|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406985|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406986|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406987|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406988|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406989|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406990|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406991|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406992|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406993|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406994|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407034|NCT00603642|O2|Outcome|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407035|NCT00603642|O1|Outcome|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407036|NCT00603642|E2|Reported Event|Romiplostim|
407037|NCT00603642|E1|Reported Event|Placebo|
406995|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406996|NCT00603746|O6|Outcome|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406997|NCT00603746|O5|Outcome|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406998|NCT00603746|O4|Outcome|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
406999|NCT00603746|O3|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407000|NCT00603746|O2|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407001|NCT00603746|O1|Outcome|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407002|NCT00603746|E6|Reported Event|FP 500 µg BID|Participants received fluticasone propionate (FP) 500 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407003|NCT00603746|E5|Reported Event|GW685698X 800 µg OD|Participants received GW685698X 800 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407004|NCT00603746|E4|Reported Event|GW685698X 600 µg OD|Participants received GW685698X 600 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407005|NCT00603746|E3|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407006|NCT00603746|E2|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407007|NCT00603746|E1|Reported Event|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. Albuterol/salbutamol inhalation aerosol was provided to be used as needed for symptomatic relief of asthma symptoms during the Treatment Period.
407008|NCT00603733|B3|Baseline|Total|Total of all reporting groups
407009|NCT00603733|B2|Baseline|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407010|NCT00603733|B1|Baseline|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407011|NCT00603733|P2|Participant Flow|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407012|NCT00603733|P1|Participant Flow|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407013|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407014|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407015|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407016|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407017|NCT00603733|O2|Outcome|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407018|NCT00603733|O1|Outcome|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407019|NCT00603733|E2|Reported Event|Pentasa®|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet"
407020|NCT00603733|E1|Reported Event|Pentasa® Modified Extended Release|"5-ASA (5-Aminosalicylate)~5-ASA (5-Aminosalicylate): 500 mg tablet (modified extended release)"
407021|NCT00603642|B3|Baseline|Total|Total of all reporting groups
407022|NCT00603642|B2|Baseline|Romiplostim|Romiplostim administered subcutaneously once weekly for 12 weeks at a starting dose of 3 µg/kg
407023|NCT00603642|B1|Baseline|Placebo|Placebo administered subcutaneously once weekly for 12 weeks
407040|NCT00603590|B1|Baseline|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407041|NCT00603590|P2|Participant Flow|Control|Identical placebo tablet
407042|NCT00603590|P1|Participant Flow|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407043|NCT00603590|O2|Outcome|Control|Identical placebo tablet
407044|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407045|NCT00603590|O2|Outcome|Control|Identical placebo tablet
407046|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407047|NCT00603590|O2|Outcome|Control|Identical placebo tablet
407048|NCT00603590|O1|Outcome|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407049|NCT00603590|E2|Reported Event|Control|Identical placebo tablet
407050|NCT00603590|E1|Reported Event|Polypill|Polypill (Atorvastatin 20 mg, Asprin 81 mg, Enalapril 2.5 mg, Hydrochlorothiazide 12.5 mg)
407051|NCT00603564|B3|Baseline|Total|Total of all reporting groups
407052|NCT00603564|B2|Baseline|Venturi|O2 administration via a conventional Venturi mask
407053|NCT00603564|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
407054|NCT00603564|P2|Participant Flow|Venturi|O2 administration via a conventional Venturi mask
407055|NCT00603564|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
407056|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
407057|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
407058|NCT00603564|O2|Outcome|Venturi|O2 administration via a conventional Venturi mask
407059|NCT00603564|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
407060|NCT00603564|E2|Reported Event|Venturi|O2 administration via a conventional Venturi mask
407061|NCT00603564|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP delivered by a helmet
407062|NCT00603538|B4|Baseline|Total|Total of all reporting groups
407063|NCT00603538|B3|Baseline|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407064|NCT00603538|B2|Baseline|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407065|NCT00603538|B1|Baseline|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407066|NCT00603538|P3|Participant Flow|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407067|NCT00603538|P2|Participant Flow|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407068|NCT00603538|P1|Participant Flow|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407069|NCT00603538|O3|Outcome|CP-751,871 20mg/kg in Combination With Chemotherapy Agents|CP-751,871 20mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407107|NCT00603525|B1|Baseline|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407291|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407070|NCT00603538|O2|Outcome|CP-751,871 10mg/kg in Combination With Chemotherapy Agents|CP-751,871 10mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407071|NCT00603538|O1|Outcome|CP-751,871 6mg/kg in Combination With Chemotherapy Agents|CP-751,871 6mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy agents; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407072|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407073|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407074|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407075|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407076|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407077|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407078|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407079|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407080|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407081|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407082|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407083|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407084|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407085|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407086|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407087|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407088|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407089|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407090|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407091|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407092|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407093|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407094|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407095|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407096|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407097|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407098|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407099|NCT00603538|O3|Outcome|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407100|NCT00603538|O2|Outcome|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407101|NCT00603538|O1|Outcome|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407102|NCT00603538|E3|Reported Event|CP-751,871 20 mg/kg in Combination With Chemotherapy Agents|CP-751,871 20 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407103|NCT00603538|E2|Reported Event|CP-751,871 10 mg/kg in Combination With Chemotherapy Agents|CP-751,871 10 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407104|NCT00603538|E1|Reported Event|CP-751,871 6 mg/kg in Combination With Chemotherapy Agents|CP-751,871 6 mg/kg was administered intravenously on Day 1 of each 21-day cycle in combination with following chemotherapy; paclitaxel 200 mg/m^2 was administered intravenously over 3 hours, then carboplatin AUC 6 was administered intravenously over 30 minutes or longer prior to the CP-751,871 infusion. Study treatment was repeated up to 4 cycles, unless disease progression or unacceptable toxicity was observed, and then up to 6 cycles if the participant showed response or stable disease at the end of Cycle 4 and agreed on additional treatment.
407105|NCT00603525|B3|Baseline|Total|Total of all reporting groups
407106|NCT00603525|B2|Baseline|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407286|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407287|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407108|NCT00603525|P3|Participant Flow|Placebo or OFA 700 mg: FU Period|Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
407109|NCT00603525|P2|Participant Flow|Ofatumumab|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
407110|NCT00603525|P1|Participant Flow|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5-25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
407111|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407112|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407113|NCT00603525|O1|Outcome|Placebo|
407114|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407115|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407116|NCT00603525|O1|Outcome|Placebo|
407117|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407118|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407119|NCT00603525|O1|Outcome|Placebo|
407120|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407121|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407122|NCT00603525|O1|Outcome|Placebo|
407123|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407124|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407125|NCT00603525|O1|Outcome|Placebo|
407126|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407127|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407128|NCT00603525|O1|Outcome|Placebo|
407129|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407130|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407131|NCT00603525|O1|Outcome|Placebo|
407132|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407133|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407134|NCT00603525|O1|Outcome|Placebo|
407135|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407136|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407137|NCT00603525|O1|Outcome|Placebo|
407138|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407139|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407140|NCT00603525|O1|Outcome|Placebo|
407141|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407142|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407143|NCT00603525|O1|Outcome|Placebo|
407144|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407145|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407146|NCT00603525|O1|Outcome|Placebo|
407147|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407148|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407149|NCT00603525|O1|Outcome|Placebo|
407150|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407151|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407152|NCT00603525|O1|Outcome|Placebo|
407153|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407154|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407155|NCT00603525|O1|Outcome|Placebo|
407156|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407157|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407158|NCT00603525|O1|Outcome|Placebo|
407159|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407160|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407161|NCT00603525|O1|Outcome|Placebo|
407162|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407163|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407164|NCT00603525|O1|Outcome|Placebo|
407165|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407166|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407167|NCT00603525|O1|Outcome|Placebo|
407168|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407169|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407170|NCT00603525|O1|Outcome|Placebo|
407171|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407172|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407173|NCT00603525|O1|Outcome|Placebo|
407174|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407175|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407176|NCT00603525|O1|Outcome|Placebo|
407177|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407178|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407179|NCT00603525|O1|Outcome|Placebo|
407180|NCT00603525|O3|Outcome|Placebo or OFA 700 mg: FU Period|
407181|NCT00603525|O2|Outcome|Ofatumumab 700 mg|
407182|NCT00603525|O1|Outcome|Placebo|
407183|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407184|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407185|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407186|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407187|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407188|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407189|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407190|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407191|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407192|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407193|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407194|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407195|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407196|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407197|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407198|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407199|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407200|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407201|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407202|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407203|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407204|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407205|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407206|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407207|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407208|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407209|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407210|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407288|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407211|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407212|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407213|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407214|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407215|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407216|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407217|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407218|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407219|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407220|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407221|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407222|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407223|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407224|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407225|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407226|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407227|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407228|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407229|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407230|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407231|NCT00603525|O2|Outcome|Ofatumumab 700 mg|Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407232|NCT00603525|O1|Outcome|Placebo|Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks).
407233|NCT00603525|E3|Reported Event|Placebo or Ofatumumab 700 mg: Follow-up Period|SAEs and non-serious AEs are reported for participants receiving either placebo or ofatumumab 700 mg in the Follow-up Period. Participants randomized to DB treatment who completed the OL Period, who did not enter the OL Period, who did not qualify for retreatment, or who were withdrawn were to be followed until the number of B-cells and circulating IgG had returned to normal (according to the central laboratory) or Baseline levels or for a maximum of 2 years from the last scheduled visit in the DB or OL Periods, whichever occurred earlier. No investigational product was administered in the Follow-up Period.
407289|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407290|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407948|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407234|NCT00603525|E2|Reported Event|Ofatumumab 700 mg: DB and OL Periods|SAEs and non-serious AEs are reported for participants receiving ofatumumab 700 mg in either the DB or OL Period. Ofatumumab 700 mg (35 ml) was administered as two 1000 ml IV infusions, one at Day 0 and the other at Day 14, in addition to background MTX treatment (7.5 to 25 mg/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period. Participants completing the 24-week DB Period without receiving rescue disease-modifying anti-rheumatic drug treatment were eligible to proceed into the 120-week OL Period to receive repeat ofatumumab treatment courses (at individualized time intervals if a clinical response had been achieved after the previous treatment course).
407235|NCT00603525|E1|Reported Event|Placebo: DB Period|Serious adverse events (SAEs) and non-serious AEs are reported for participants receiving placebo in the DB Period. Placebo was administered as two 1000 milliliter (ml) intravenous (IV) infusions, one at Day 0 and the other at Day 14, in addition to background methotrexate (MTX) treatment (7.5 to 25 milligrams [mg]/week [oral, intramuscular, or subcutaneous] for 24 weeks) in the DB Period.
407236|NCT00603512|B6|Baseline|Total|Total of all reporting groups
407237|NCT00603512|B5|Baseline|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407238|NCT00603512|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407239|NCT00603512|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407240|NCT00603512|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407241|NCT00603512|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407242|NCT00603512|P5|Participant Flow|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407243|NCT00603512|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407244|NCT00603512|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407245|NCT00603512|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407246|NCT00603512|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407247|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407248|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407249|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407250|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407251|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407252|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407253|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407254|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407255|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407256|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407257|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407258|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407259|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407260|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407261|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407262|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407263|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407264|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407265|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407266|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407267|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407268|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407269|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407270|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407271|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407272|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407273|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407274|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407275|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407276|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407277|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407278|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407279|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407280|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407281|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407282|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407283|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407284|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407285|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407949|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407292|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407293|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407294|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407295|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407296|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407297|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407298|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407299|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407300|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407301|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407302|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407303|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407304|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407305|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407306|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407307|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407308|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407309|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407310|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407311|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407312|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407313|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407314|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407315|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407316|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407317|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407318|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407319|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407320|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407321|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407322|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407323|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407324|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407325|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407326|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407327|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407328|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407329|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407330|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407331|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407332|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407333|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407334|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407335|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407336|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407337|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407338|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407339|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407340|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407341|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407342|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407343|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407344|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407345|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407346|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407347|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407348|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407349|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407350|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407351|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407352|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407353|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407354|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407355|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407356|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407357|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407358|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407359|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407360|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407361|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407362|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407363|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407364|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407365|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407366|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407367|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407368|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407369|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407370|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407371|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407372|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407373|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407374|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407375|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407376|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407377|NCT00603512|O5|Outcome|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407378|NCT00603512|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407379|NCT00603512|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407380|NCT00603512|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407381|NCT00603512|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407382|NCT00603512|E5|Reported Event|Placebo|Placebo tablet matched to CP-690,550 orally twice daily for 12 weeks.
407383|NCT00603512|E4|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 12 weeks.
407384|NCT00603512|E3|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 12 weeks.
407385|NCT00603512|E2|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 12 weeks.
407386|NCT00603512|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 12 weeks.
407387|NCT00603473|B1|Baseline|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407388|NCT00603473|P1|Participant Flow|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407389|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407390|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407950|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407391|NCT00603473|O1|Outcome|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407392|NCT00603473|E1|Reported Event|Gabapentin|The dosage of oral solution for subjects aged 3 to 12 years was calculated based on their body weight. The dose was titrated for the first 3 days of the treatment period. Subjects aged 3 to 4 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 40 mg/kg/day from Day 3. Subjects aged 5 to 12 years received gabapentin 10 mg/kg/day on Day 1, 20 mg/kg/day on Day 2 and 25 to 35 mg/kg/day from Day 3. Subjects aged 13 to 15 years received gabapentin 600 mg/day on Day 1, 1200 mg/day on Day 2 and 1200 or 1800 mg/day from Day 3. After Day 3, the dose was adjusted if necessary within the range of maintenance doses. The maximum daily dose was 600 mg for Day 1, 1200 mg for Day 2, and 1800 mg for Day 3 and thereafter.
407393|NCT00603447|B8|Baseline|Total|Total of all reporting groups
407394|NCT00603447|B7|Baseline|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407395|NCT00603447|B6|Baseline|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407396|NCT00603447|B5|Baseline|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407397|NCT00603447|B4|Baseline|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407398|NCT00603447|B3|Baseline|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407399|NCT00603447|B2|Baseline|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407400|NCT00603447|B1|Baseline|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407401|NCT00603447|P7|Participant Flow|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407402|NCT00603447|P6|Participant Flow|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407403|NCT00603447|P5|Participant Flow|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407404|NCT00603447|P4|Participant Flow|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407405|NCT00603447|P3|Participant Flow|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407406|NCT00603447|P2|Participant Flow|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407407|NCT00603447|P1|Participant Flow|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407614|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407408|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407409|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407410|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407411|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407412|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407413|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407414|NCT00603447|O7|Outcome|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407415|NCT00603447|O6|Outcome|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407416|NCT00603447|O5|Outcome|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407417|NCT00603447|O4|Outcome|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407418|NCT00603447|O3|Outcome|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407419|NCT00603447|O2|Outcome|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407420|NCT00603447|O1|Outcome|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator’s discretion.
407421|NCT00603447|E7|Reported Event|7: CFZ 20/27 mg/m² + LEN 25 mg|In the Expansion portion, treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407422|NCT00603447|E6|Reported Event|6: CFZ 20/27 mg/m² + LEN 25 mg|Treatment consisted of carfilzomib 20 mg/m² on Days 1 and 2 of Cycle 1, followed by 27 mg/m² for the remainder of treatment (Days 8, 9, 15, and 16 of Cycle 1 and Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles); lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407423|NCT00603447|E5|Reported Event|5: CFZ 20 mg/m² + LEN 25 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 25 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15 and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407424|NCT00603447|E4|Reported Event|4: CFZ 20 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 20 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407425|NCT00603447|E3|Reported Event|3: CFZ 15 mg/m² + LEN 20 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 20 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407426|NCT00603447|E2|Reported Event|2: CFZ 15 mg/m² + LEN 15 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 15 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407427|NCT00603447|E1|Reported Event|1: CFZ 15 mg/m² + LEN 10 mg|Treatment during Cycles 1 through 12 consisted of carfilzomib 15 mg/m² on Days 1, 2, 8, 9, 15, and 16; lenalidomide 10 mg on Days 1 to 21; and 40 mg dexamethasone on Days 1, 8, and 15, and 22. For Cycles 13 and higher, carfilzomib could be omitted on Days 8 and 9 at the investigator's discretion.
407428|NCT00603408|B1|Baseline|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407429|NCT00603408|P1|Participant Flow|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407430|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407431|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407432|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407433|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407434|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407435|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407436|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407437|NCT00603408|O1|Outcome|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407438|NCT00603408|E1|Reported Event|Cisplatin + Radiation + Recommended Surgery|"Cisplatin 75 mg/m^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10~Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks.~Surgery (recommended) mastectomy with/without axillary lymph node dissection"
407439|NCT00603382|B7|Baseline|Total|Total of all reporting groups
407440|NCT00603382|B6|Baseline|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407441|NCT00603382|B5|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407442|NCT00603382|B4|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407443|NCT00603382|B3|Baseline|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407444|NCT00603382|B2|Baseline|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407445|NCT00603382|B1|Baseline|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407446|NCT00603382|P6|Participant Flow|FP 100 µg BID|Participants received fluticasone propionate (FP) 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407447|NCT00603382|P5|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407448|NCT00603382|P4|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407449|NCT00603382|P3|Participant Flow|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407450|NCT00603382|P2|Participant Flow|GW685698X 25 µg OD|Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407451|NCT00603382|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407452|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407453|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407454|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407455|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407456|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407457|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407458|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407459|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407460|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407461|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407462|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407463|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407464|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407465|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407951|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407466|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407467|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407468|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407469|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407470|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407471|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407472|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407473|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407474|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407475|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407476|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407477|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407478|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407479|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407480|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407481|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407482|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407483|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407484|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407485|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407615|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407486|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407487|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407488|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407489|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407490|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407491|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407492|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407493|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407494|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407495|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407496|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407497|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407498|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407499|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407500|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407501|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407502|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407503|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407504|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407505|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407616|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407506|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407507|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407508|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407509|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407510|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407511|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407512|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407513|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407514|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407515|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407516|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407517|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407518|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407519|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407520|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407521|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407522|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407523|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407524|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407525|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407617|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
416038|NCT00577135|O3|Outcome|Low Intensification|
407526|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407527|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407528|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407529|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407530|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407531|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407532|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407533|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407534|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407535|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407536|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407537|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407538|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407539|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407540|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407541|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407542|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407543|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407544|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407545|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407618|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407546|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407547|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407548|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407549|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407550|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407551|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407552|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407553|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407554|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407555|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407556|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407557|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407558|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407559|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407560|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407561|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407562|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407563|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407564|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407565|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407619|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
416039|NCT00577135|O2|Outcome|Continuous Infusion|
407566|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407567|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407568|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407569|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407570|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407571|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407572|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407573|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407574|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407575|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407576|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407577|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407578|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407579|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407580|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407581|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407582|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407583|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407584|NCT00603382|O6|Outcome|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407585|NCT00603382|O5|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407620|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407586|NCT00603382|O4|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407587|NCT00603382|O3|Outcome|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407588|NCT00603382|O2|Outcome|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407589|NCT00603382|O1|Outcome|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407590|NCT00603382|E6|Reported Event|FP 100 µg BID|Participants received FP 100 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407591|NCT00603382|E5|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407592|NCT00603382|E4|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407593|NCT00603382|E3|Reported Event|GW685698X 50 µg OD|Participants received GW685698X 50 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407594|NCT00603382|E2|Reported Event|GW685698X 25 µg OD|Participants received GW685698X 25 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407595|NCT00603382|E1|Reported Event|Placebo|Participants received placebo OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407596|NCT00603304|B3|Baseline|Total|Total of all reporting groups
407597|NCT00603304|B2|Baseline|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407598|NCT00603304|B1|Baseline|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407599|NCT00603304|P2|Participant Flow|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407600|NCT00603304|P1|Participant Flow|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407601|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407602|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407603|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407604|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407605|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407606|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407607|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407608|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407609|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407610|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407611|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407612|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407613|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407833|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407621|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407622|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407623|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407624|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407625|NCT00603304|O2|Outcome|Placebo|Participants received either one, two, and then three 320 mg chocolate-colored placebo gelcaps with dose escalations at 24 and 48 weeks.
407626|NCT00603304|O1|Outcome|Saw Palmetto|Participants received one, two, and then three 320 mg chocolate-colored soft gelcaps containing a standardized saw palmetto fruit extract with dose escalations at 24 and 48 weeks.
407627|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
407628|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
407629|NCT00603304|O2|Outcome|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
407630|NCT00603304|O1|Outcome|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
407631|NCT00603304|E2|Reported Event|Placebo|One, two, and then three 320 mg placebo gelcaps with dose escalations at 24 and 48 weeks.
407632|NCT00603304|E1|Reported Event|Saw Palmetto|One, two, and then three 320 mg gelcaps with dose escalations at 24 and 48 weeks.
407633|NCT00603291|B4|Baseline|Total|Total of all reporting groups
407634|NCT00603291|B3|Baseline|Matching Placebo|matching placebo tablets
407635|NCT00603291|B2|Baseline|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
407636|NCT00603291|B1|Baseline|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
407637|NCT00603291|P3|Participant Flow|Matching Placebo|matching placebo tablets
407638|NCT00603291|P2|Participant Flow|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
407639|NCT00603291|P1|Participant Flow|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
407640|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
407641|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
407642|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
407643|NCT00603291|O3|Outcome|Matching Placebo|matching placebo tablets
407644|NCT00603291|O2|Outcome|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
407645|NCT00603291|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
407646|NCT00603291|E3|Reported Event|Matching Placebo|matching placebo tablets
407647|NCT00603291|E2|Reported Event|Lorcaserin 10 mg QD|lorcaserin 10 mg QD tablets
407648|NCT00603291|E1|Reported Event|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
407649|NCT00603278|B7|Baseline|Total|Total of all reporting groups
407650|NCT00603278|B6|Baseline|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407651|NCT00603278|B5|Baseline|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407652|NCT00603278|B4|Baseline|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407653|NCT00603278|B3|Baseline|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407654|NCT00603278|B2|Baseline|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407655|NCT00603278|B1|Baseline|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407656|NCT00603278|P6|Participant Flow|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407657|NCT00603278|P5|Participant Flow|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407658|NCT00603278|P4|Participant Flow|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407834|NCT00603265|E3|Reported Event|Placebo|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
416040|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
407659|NCT00603278|P3|Participant Flow|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407660|NCT00603278|P2|Participant Flow|GW685698X 100 µg OD|Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407661|NCT00603278|P1|Participant Flow|Placebo|Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407662|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407663|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407664|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407665|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407666|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407667|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407668|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407669|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407670|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407671|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407672|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407673|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407674|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407675|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407676|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407677|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407678|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407679|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407680|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407681|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407682|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407683|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407684|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407685|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407686|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407687|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407688|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407689|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407690|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407691|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407692|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407693|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407694|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407695|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407696|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407697|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407698|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407952|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407699|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407700|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407701|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407702|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407703|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407704|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407705|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407706|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407707|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407708|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407709|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407710|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407711|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407712|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407713|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407714|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407715|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407716|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407717|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407718|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407835|NCT00603265|E2|Reported Event|Duloxetine|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407719|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407720|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407721|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407722|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407723|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407724|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407725|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407726|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407727|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407728|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407729|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407730|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407731|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407732|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407733|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407734|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407735|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407736|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407737|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407738|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407836|NCT00603265|E1|Reported Event|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407739|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407740|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407741|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407742|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407743|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407744|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407745|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407746|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407747|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407748|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407749|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407750|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407751|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407752|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407753|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407754|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407755|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407756|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407757|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407758|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407837|NCT00603239|B3|Baseline|Total|Total of all reporting groups
407759|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407760|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407761|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407762|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407763|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407764|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407765|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407766|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407767|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407768|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407769|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407770|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407771|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407772|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407773|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407774|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407775|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407776|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407777|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407778|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407936|NCT00602472|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407779|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407780|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407781|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407782|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407783|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407784|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407785|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407786|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407787|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407788|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407789|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407790|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407791|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407792|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407793|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407794|NCT00603278|O6|Outcome|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the DPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407795|NCT00603278|O5|Outcome|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407796|NCT00603278|O4|Outcome|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407797|NCT00603278|O3|Outcome|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407798|NCT00603278|O2|Outcome|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407937|NCT00602472|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
407799|NCT00603278|O1|Outcome|Placebo|Participants received placebo once daily OD in the evening from the DPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407800|NCT00603278|E6|Reported Event|FP 250 µg BID|Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407801|NCT00603278|E5|Reported Event|GW685698X 400 µg OD|Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407802|NCT00603278|E4|Reported Event|GW685698X 300 µg OD|Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407803|NCT00603278|E3|Reported Event|GW685698X 200 µg OD|Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407804|NCT00603278|E2|Reported Event|GW685698X 100 µg OD|Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
407805|NCT00603278|E1|Reported Event|Placebo|Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
407806|NCT00603265|B4|Baseline|Total|Total of all reporting groups
407807|NCT00603265|B3|Baseline|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407808|NCT00603265|B2|Baseline|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407809|NCT00603265|B1|Baseline|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407810|NCT00603265|P3|Participant Flow|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407811|NCT00603265|P2|Participant Flow|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407812|NCT00603265|P1|Participant Flow|ADL5859|2 x 50 milligrams (mg) ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407813|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407814|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407815|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407816|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407817|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407818|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407819|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407820|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407821|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407822|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407823|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407824|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407825|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407826|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407827|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407828|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407829|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407830|NCT00603265|O1|Outcome|ADL5859|2 x 50 mg ADL5859 capsules administered orally once in the morning and once in the evening for 28 days
407831|NCT00603265|O3|Outcome|Placebo|2 placebo capsules filled with lactose administered orally once in the morning and once in the evening for 28 days
407832|NCT00603265|O2|Outcome|Duloxetine|2 x 30 mg duloxetine capsules administered orally once in the morning and 2 placebo capsules filled with lactose administered orally once in the evening for 28 days
407838|NCT00603239|B2|Baseline|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407839|NCT00603239|B1|Baseline|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407840|NCT00603239|P2|Participant Flow|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407841|NCT00603239|P1|Participant Flow|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407842|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407843|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407844|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407845|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407846|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407847|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407848|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407849|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407850|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407851|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407852|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407853|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407854|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407855|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407856|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407857|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407858|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407859|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407860|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407861|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407862|NCT00603239|O2|Outcome|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407863|NCT00603239|O1|Outcome|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407864|NCT00603239|E2|Reported Event|Placebo|Placebo equivalent volume to exenatide 5 mcg for 4 weeks, follwed by placebo equivalent volume to exenatide 10 mcg twice daily for 22 weeks
407865|NCT00603239|E1|Reported Event|Exenatide Twice Daily (BID)|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 22 weeks
407866|NCT00603187|B1|Baseline|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407867|NCT00603187|P1|Participant Flow|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407868|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407869|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407870|NCT00603187|O1|Outcome|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407871|NCT00603187|E1|Reported Event|Oral Acyline|20 mg dose of GIPET enhanced oral acyline for 7 days
407872|NCT00603044|B3|Baseline|Total|Total of all reporting groups
407873|NCT00603044|B2|Baseline|No Treatment|Subjects in this arm received no treatment.
407874|NCT00603044|B1|Baseline|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407875|NCT00603044|P2|Participant Flow|No Treatment|Subjects in this arm received no treatment.
407876|NCT00603044|P1|Participant Flow|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407877|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407878|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407879|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407880|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407881|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407938|NCT00602472|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407882|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407883|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407884|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407885|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407886|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407887|NCT00603044|O2|Outcome|No Treatment|Subjects in this arm received no treatment.
407888|NCT00603044|O1|Outcome|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407889|NCT00603044|E2|Reported Event|No Treatment|Subjects in this arm received no treatment.
407890|NCT00603044|E1|Reported Event|Fluticasone Furoate|"55 mcg/nostril once daily for 2 weeks prior to adenotonsillectomy~fluticasone furoate: treatment with fluticasone furoate (55 mcg/nostril once daily) for 2 weeks prior to adenotonsillectomy"
407891|NCT00603018|B1|Baseline|1/Recovered Anorevia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
407892|NCT00603018|P1|Participant Flow|Participants Recovered From Anorexia Before + After Fluoxetine|"Participants recovered from anorexia~Fluoxetine: before 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
407893|NCT00603018|O2|Outcome|1/Recovered Anorexia After 8 Weeks of Treatment|"1/Recovered anorexia after 8 weeks of treatment~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
407894|NCT00603018|O1|Outcome|1/Recovered Anorexia Before 8 Weeks of Treatment|"1/Recovered anorexia before 8 weeks of treatment~Baseline"
407895|NCT00603018|E1|Reported Event|1/Recovered Anorexia|"Recovered anorexia~Fluoxetine: 8 weeks of fluoxetine(2.5mg,5mg,10mg,20mg,30mg,40mg,40mg,40mg)each week per day."
407896|NCT00602927|B3|Baseline|Total|Total of all reporting groups
407897|NCT00602927|B2|Baseline|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407898|NCT00602927|B1|Baseline|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407899|NCT00602927|P2|Participant Flow|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407900|NCT00602927|P1|Participant Flow|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407901|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407902|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407903|NCT00602927|O2|Outcome|Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407904|NCT00602927|O1|Outcome|Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407905|NCT00602927|E2|Reported Event|Varenicline First, Then Placebo|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407906|NCT00602927|E1|Reported Event|Placebo First, Then Varenicline|Days 1 – 3: 0.5 mg once a day orally Days 4 – 7: 0.5 mg twice a day orally Days 8 – 13: 1 mg twice a day orally
407907|NCT00602836|B1|Baseline|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
407908|NCT00602836|P1|Participant Flow|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
407909|NCT00602836|O1|Outcome|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
407910|NCT00602836|E1|Reported Event|PCR-Lenalidomide|Pentostatin, Cyclophosphamide, Rituximab + Lenalidomide
407911|NCT00602771|B3|Baseline|Total|Total of all reporting groups
407912|NCT00602771|B2|Baseline|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
407913|NCT00602771|B1|Baseline|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
407914|NCT00602771|P2|Participant Flow|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
407915|NCT00602771|P1|Participant Flow|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
407916|NCT00602771|O2|Outcome|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
407917|NCT00602771|O1|Outcome|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
407918|NCT00602771|E2|Reported Event|Arm II (Closed to Accrual as of November 2008)|Patients receive 400 mg of oral tipifarnib twice daily on days 1-14 and 200 mg of oral etoposide once daily on days 1-3 and 8-10.
407919|NCT00602771|E1|Reported Event|Arm I|Patients receive 600 mg of oral tipifarnib twice daily on days 1-14 and 100 mg of oral etoposide once daily on days 1-3 and 8-10.
407920|NCT00602641|B3|Baseline|Total|Total of all reporting groups
407939|NCT00602472|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
407940|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407941|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407942|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407921|NCT00602641|B2|Baseline|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~lenalidomide: Given PO"
407922|NCT00602641|B1|Baseline|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression.~melphalan: Given PO~prednisone: Given PO~thalidomide: Given PO"
407923|NCT00602641|P2|Participant Flow|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan 5 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and lenalidomide 10 mg PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide 10 mg PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407924|NCT00602641|P1|Participant Flow|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan 9 mg/m^2 PO and prednisone 100 mg PO daily on days 1-4, and thalidomide 100 mg PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide 100 mg PO daily and continue in the absence of disease progression."
407925|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407926|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
407927|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407928|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
407929|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407930|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
407931|NCT00602641|O2|Outcome|Arm II (mPR-R)|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407932|NCT00602641|O1|Outcome|Arm I (MPT-T)|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
407933|NCT00602641|E2|Reported Event|mPR-R|"Patients receive lower-dose melphalan, prednisone and lenalidomide (Revlimid®) induction plus lenalidomide maintenance (mPR-R).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and lenalidomide PO on days 1-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive lenalidomide PO daily on days 1-21. Courses repeat every 28 days in the absence of disease progression."
407934|NCT00602641|E1|Reported Event|MPT-T|"Patients receive melphalan, prednisone and thalidomide induction plus thalidomide maintenance (MPT-T).~INDUCTION THERAPY: Patients receive melphalan PO and prednisone PO daily on days 1-4, and thalidomide PO daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Patients receive thalidomide PO daily and continue in the absence of disease progression."
407935|NCT00602472|B3|Baseline|Total|Total of all reporting groups
407953|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407954|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407955|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407956|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407957|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407958|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407959|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407960|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407961|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407962|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407963|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407964|NCT00602472|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407965|NCT00602472|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
407966|NCT00602472|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5mg
407967|NCT00602472|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
407968|NCT00602446|B1|Baseline|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
407969|NCT00602446|P1|Participant Flow|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
407970|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
407971|NCT00602446|O1|Outcome|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
407972|NCT00602446|E1|Reported Event|Deferasirox Treated|Includes patients that were treated with deferasirox for 6 months.
407973|NCT00602420|B3|Baseline|Total|Total of all reporting groups
407974|NCT00602420|B2|Baseline|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
407975|NCT00602420|B1|Baseline|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
407976|NCT00602420|P2|Participant Flow|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
407977|NCT00602420|P1|Participant Flow|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
407978|NCT00602420|O2|Outcome|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
407979|NCT00602420|O1|Outcome|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
407980|NCT00602420|E2|Reported Event|Placebo|"Patients receive an oral placebo twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~placebo: Oral placebo twice daily for 5-8 days."
407981|NCT00602420|E1|Reported Event|Naproxen|"Patients receive oral naproxen twice daily beginning on the day pegfilgrastim is administered (day 2, 3, or 4) and continuing for 5-8 days.~naproxen: Oral naproxen twice daily for 5-8 days."
407982|NCT00602355|B4|Baseline|Total|Total of all reporting groups
407983|NCT00602355|B3|Baseline|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
407984|NCT00602355|B2|Baseline|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407985|NCT00602355|B1|Baseline|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407986|NCT00602355|P3|Participant Flow|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
408020|NCT00602043|B1|Baseline|First Line Endocrine Therapy for a Stage IV Disease|
408021|NCT00602043|P1|Participant Flow|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
407987|NCT00602355|P2|Participant Flow|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407988|NCT00602355|P1|Participant Flow|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407989|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
407990|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407991|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407992|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
407993|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407994|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407995|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
407996|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407997|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
407998|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
407999|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408000|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408001|NCT00602355|O3|Outcome|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
408002|NCT00602355|O2|Outcome|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408003|NCT00602355|O1|Outcome|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408004|NCT00602355|E3|Reported Event|3 (IPT)|"Participants receiving interpersonal psychotherapy (IPT) alone~Interpersonal psychotherapy (IPT): IPT will be administered in 13 individual 50-minute sessions over 13 weeks. These sessions will focus on improving relationships with others, setting goals, and increasing coping skills."
408005|NCT00602355|E2|Reported Event|2 (Sertraline)|"Participants receiving active medication sertraline with clinical management plus mothercrafting~Sertraline: Participants assigned to sertraline treatment will take 25 to 50 mg daily for Weeks 1 through 3, and dosage will be increased to 100 to 150 mg daily in Weeks 4 through 10. Participants will be titrated up to 200 mg daily at Week 11 for the final 2 weeks of treatment. In addition, at each week participants will receive specific “mother-crafting” techniques keyed to the baby’s age and development. The mother-crafting component is aimed at providing relevant information to the mother about infant care.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408006|NCT00602355|E1|Reported Event|1 (Placebo)|"Participants receiving placebo pill with clinical management plus mothercrafting~Placebo: Participants taking the placebo will follow the same titration schedule as those taking sertraline. In addition, the participates will receive the same specific “mother-crafting” techniques as those taking sertraline.~Clinical management: Clinical management includes treatment as usual for those receiving medication for depression.~Mothercrafting: Mother-crafting techniques are keyed to the baby's age and development. The mother-crafting component is aimed at providing relevant information about infant care"
408007|NCT00602290|B4|Baseline|Total|Total of all reporting groups
408008|NCT00602290|B3|Baseline|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
408009|NCT00602290|B2|Baseline|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408022|NCT00602043|O2|Outcome|Diagnostic FES: Patients With FES Negative Sites of Disease|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had some or all disease sites negative for FES uptake on the baseline diagnostic FES PET scan."
408010|NCT00602290|B1|Baseline|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408011|NCT00602290|P3|Participant Flow|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
408012|NCT00602290|P2|Participant Flow|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408013|NCT00602290|P1|Participant Flow|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408014|NCT00602290|O3|Outcome|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
408015|NCT00602290|O2|Outcome|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408016|NCT00602290|O1|Outcome|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408017|NCT00602290|E3|Reported Event|3 - Methylphenidate + Citalopram|"Participants will take a combination of methylphenidate and citalopram for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion."
408018|NCT00602290|E2|Reported Event|2 - Methylphenidate + Placebo|"Participants will take a combination of methylphenidate and placebo for 16 weeks~Methylphenidate (MPH): MPH dosage will be 5 to 40 mg a day. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, MPH dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408019|NCT00602290|E1|Reported Event|1 - Citalopram + Placebo|"Participants will take a combination of citalopram and placebo for 16 weeks~Citalopram: Citalopram dosage will be 20 to 60 mg a day. Participants will begin taking one 20-mg capsule once per day, and this dosage may be increased or decreased depending on the participant's response to the medication. Participants will continue on their assigned dosage of citalopram until treatment completion.~Placebo: Placebo pills will be taken in combination with the active pills. Participants will initially take 1 capsule twice per day, which will be increased to a maximum of 16 capsules twice per day. After Visit 11, placebo dosage will be gradually reduced over 2 weeks until participants are no longer taking any capsules."
408023|NCT00602043|O1|Outcome|Diagnostic FES: Average FES SUVmean >1.5, no Negative Sites|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~This group represents patients who had positive FES uptake at all disease sites on the baseline diagnostic FES PET scan.~laboratory biomarker analysis: Correlative studies"
408024|NCT00602043|E1|Reported Event|Diagnostic (FES)|"Patients undergo [^18F] FES PET scan. Patients also undergo standard clinical fludeoxyglucose F 18 (FDG)-PET or FDG-PET/CT scan up to 14 days prior to [^18F] FES PET scan.~Patients begin clinically indicated endocrine therapy.~Patients are followed-up to determine response on the therapy for 6 months using clinical exams, tumor marker assays, conventional imaging and standard clinical FDG PET/CT.~laboratory biomarker analysis: Correlative studies"
408025|NCT00601965|B5|Baseline|Total|Total of all reporting groups
408026|NCT00601965|B4|Baseline|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
408027|NCT00601965|B3|Baseline|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408028|NCT00601965|B2|Baseline|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
408029|NCT00601965|B1|Baseline|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408030|NCT00601965|P4|Participant Flow|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
408031|NCT00601965|P3|Participant Flow|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408032|NCT00601965|P2|Participant Flow|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
408033|NCT00601965|P1|Participant Flow|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408034|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
408035|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408036|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
408037|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408038|NCT00601965|O4|Outcome|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
408039|NCT00601965|O3|Outcome|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408040|NCT00601965|O2|Outcome|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
408041|NCT00601965|O1|Outcome|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408042|NCT00601965|E4|Reported Event|Placebo + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram"
408043|NCT00601965|E3|Reported Event|Placebo + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks pill placebo~Escitalopram: 20 mg daily oral escitalopram~Placebo: Placebo pill of daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408044|NCT00601965|E2|Reported Event|Escitalopram + no CBT|"12 weeks open-label escitalopram, 16 weeks continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram"
408045|NCT00601965|E1|Reported Event|Escitalopram + CBT|"12 weeks open-label escitalopram, 16 weeks cognitive behavioral therapy plus continuation escitalopram, 28 weeks maintenance escitalopram~Escitalopram: 20 mg daily oral escitalopram~Cognitive behavioral therapy (CBT): 16 weekly 1-hour sessions"
408046|NCT00601952|B3|Baseline|Total|Total of all reporting groups
408047|NCT00601952|B2|Baseline|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
408071|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
416041|NCT00577135|O4|Outcome|High Intensification|
408048|NCT00601952|B1|Baseline|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
408049|NCT00601952|P2|Participant Flow|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
408050|NCT00601952|P1|Participant Flow|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
408051|NCT00601952|O2|Outcome|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
408052|NCT00601952|O1|Outcome|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
408053|NCT00601952|E2|Reported Event|2 Attention Control Condition (ACC)|The ACC condition was identical to the ABM procedure with the exception that the probe appeared with equal frequency in the position of the threat and neutral words, such that attention was neither trained towards nor away from threat.
408054|NCT00601952|E1|Reported Event|1 Attention Bias Modification (ABM)|The ABM comprised a probe detection paradigm described above, modified to facilitate the allocation of attention away from threatening material. In this task, the probe always replaced the neutral word. Stimuli comprised a different set of 12 threat-neutral word pairs different than those used in the attention bias assessment. Participants completed 288 training trials: 2 (probe type) x 2 (probe location) x 2 (threat location) x 12 (threat-neutral word pairs) x 3 (repetition). Thus, although there were no explicit instructions to direct attention away from threat words, on all trials, the position of the neutral word indicated the position of the probe.
408055|NCT00601926|B1|Baseline|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408056|NCT00601926|P1|Participant Flow|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408057|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408058|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408059|NCT00601926|O1|Outcome|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408060|NCT00601926|E1|Reported Event|Bevacizumab|"15 mg/kg over 90 minutes~bevacizumab: 15 mg/kg over 90 minutes every 3 weeks"
408061|NCT00601900|B3|Baseline|Total|Total of all reporting groups
408062|NCT00601900|B2|Baseline|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408063|NCT00601900|B1|Baseline|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408064|NCT00601900|P2|Participant Flow|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408065|NCT00601900|P1|Participant Flow|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408066|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408067|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408068|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408069|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408070|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408176|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408177|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408072|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408073|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408074|NCT00601900|O2|Outcome|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408075|NCT00601900|O1|Outcome|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408076|NCT00601900|E2|Reported Event|Arm II (Endocrine Therapy)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408077|NCT00601900|E1|Reported Event|Arm I (Endocrine Therapy With Monoclonal Antibody)|Patients receive endocrine therapy* (tamoxifen citrate* or letrozole) PO QD on days 1-21 and bevacizumab 15 mg/kg IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
408078|NCT00601835|B3|Baseline|Total|Total of all reporting groups
408079|NCT00601835|B2|Baseline|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408080|NCT00601835|B1|Baseline|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408081|NCT00601835|P2|Participant Flow|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408082|NCT00601835|P1|Participant Flow|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408083|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408084|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408085|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408086|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408087|NCT00601835|O2|Outcome|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408088|NCT00601835|O1|Outcome|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408089|NCT00601835|E2|Reported Event|United States Td Vaccine Group|Participants received the US manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (DECAVAC®)
408090|NCT00601835|E1|Reported Event|Canadian Td Vaccine Group|Participants received the Canadian manufactured Tetanus and Diphtheria Toxoids Adsorbed vaccine for Adult Use (TENIVAC™)
408091|NCT00601796|B1|Baseline|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408092|NCT00601796|P1|Participant Flow|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408093|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408094|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408117|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408095|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408096|NCT00601796|O1|Outcome|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408097|NCT00601796|E1|Reported Event|Combination Immunotherapy|"Vaccine + Cytoxan + ATRA as outlined in Detailed Description~Vaccine Treatment : We created a vaccine in which irradiated allogeneic lung adenocarcinoma cells are combined with a bystander K562 cell line transfected with hCD40L and hGM-CSF. By recruiting and activating dendritic cells, we hypothesized the vaccine would induce tumor regression in metastatic lung adenocarcinoma. Intradermal vaccine was given every 14 days x3, followed by monthly x3.~All-trans retinoic acid (ATRA) : All-trans retinoic acid was given (150/mg/m^2/day) after 1st and 4th vaccines to enhance dendritic differentiation.~Cyclophosphamide : Cyclophosphamide (300 mg/m^2 IV) was administered before 1st and 4th vaccines to deplete regulatory T-cells."
408098|NCT00601731|B13|Baseline|Total|Total of all reporting groups
408099|NCT00601731|B12|Baseline|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408100|NCT00601731|B11|Baseline|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408101|NCT00601731|B10|Baseline|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408102|NCT00601731|B9|Baseline|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408103|NCT00601731|B8|Baseline|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408104|NCT00601731|B7|Baseline|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
408105|NCT00601731|B6|Baseline|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
408106|NCT00601731|B5|Baseline|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408107|NCT00601731|B4|Baseline|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408108|NCT00601731|B3|Baseline|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408109|NCT00601731|B2|Baseline|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408110|NCT00601731|B1|Baseline|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408111|NCT00601731|P4|Participant Flow|Canada Control|Newly enrolled age-matched subjects that received the complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408112|NCT00601731|P3|Participant Flow|Canada Sites|Canadian vaccine group that received primary vaccination with MenACWY (adjuvanted and unadjuvanted) vaccine at 2,4 months of age with 12 month booster or at 2, 4, 6 months with or without a booster vaccination.
408113|NCT00601731|P2|Participant Flow|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408114|NCT00601731|P1|Participant Flow|UK Site|UK vaccine group that received primary vaccine schedule of MenACWY (adjuvanted and unadjuvanted) vaccine at 2, 3 and 4 months with booster at 12 months of age, enrolled at either 40 or 60 months of age into the current study as follow-on participants.
408115|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408116|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
416042|NCT00577135|O3|Outcome|Low Intensification|
408118|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408119|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408120|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
408121|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
408122|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408123|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408124|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408125|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408126|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408127|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408128|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408129|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408130|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408131|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408132|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
408133|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
408134|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408135|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408136|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408137|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408138|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408139|NCT00601731|O12|Outcome|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408140|NCT00601731|O11|Outcome|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408141|NCT00601731|O10|Outcome|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408142|NCT00601731|O9|Outcome|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408143|NCT00601731|O8|Outcome|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408144|NCT00601731|O7|Outcome|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
408145|NCT00601731|O6|Outcome|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
408146|NCT00601731|O5|Outcome|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408147|NCT00601731|O4|Outcome|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408148|NCT00601731|O3|Outcome|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408149|NCT00601731|O2|Outcome|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408150|NCT00601731|O1|Outcome|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408151|NCT00601731|E12|Reported Event|Ca Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2 and 12 months or only at 12 months of age.
408152|NCT00601731|E11|Reported Event|Ca2,4-/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of the quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408153|NCT00601731|E10|Reported Event|Ca2,4,12-|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster vaccination of the quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408154|NCT00601731|E9|Reported Event|Ca2,4+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age.
408155|NCT00601731|E8|Reported Event|Ca2,4,12+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408156|NCT00601731|E7|Reported Event|Ca2,4,6+/12PS|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age followed by a reduced booster vaccination of quadrivalent MenACWY polysaccharide vaccine (Menomune [1/5 dose]) at 12 months of age
408157|NCT00601731|E6|Reported Event|Ca2,4,6+|Canadian vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 4 and 6 months of age without any booster vaccination.
408158|NCT00601731|E5|Reported Event|UK Control|Newly enrolled age-matched subjects that received a complete vaccination course of routine monovalent MenC conjugate vaccine at 2, 3 and 4 months of age without any booster vaccination.
408159|NCT00601731|E4|Reported Event|UK2,4,12-|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine without adjuvant at 12 months of age.
408160|NCT00601731|E3|Reported Event|UK2,4C/12+|UK vaccine group receiving primary vaccine of monovalent MenC-CRM197 conjugate vaccine (Menjugate) at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408161|NCT00601731|E2|Reported Event|UK2,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2 and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408162|NCT00601731|E1|Reported Event|UK2,3,4,12+|UK vaccine group receiving primary vaccine of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 2, 3, and 4 months of age followed by a booster dose of quadrivalent MenACWY-CRM197 conjugate vaccine with adjuvant at 12 months of age.
408163|NCT00601523|B3|Baseline|Total|Total of all reporting groups
408164|NCT00601523|B2|Baseline|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408165|NCT00601523|B1|Baseline|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408166|NCT00601523|P2|Participant Flow|Patients From 248.636|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.636 (NCT00558025) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
408167|NCT00601523|P1|Participant Flow|Patients From 248.524|Pramipexole ER 0.375-4.5 mg. Stratified cohort of patients who had previously completed 248.524 (NCT00479401) and previously received Pramipexole Extended Release (PPX ER), Pramipexole Immediate Release (PPX IR), or Placebo.
408168|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408169|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408170|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408171|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408172|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408173|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408174|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408175|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
416043|NCT00577135|O2|Outcome|Continuous Infusion|
408178|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408179|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408180|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408181|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408182|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408183|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408184|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408185|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408186|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408187|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408188|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408189|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408190|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408191|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408192|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408193|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408194|NCT00601523|O2|Outcome|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408195|NCT00601523|O1|Outcome|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408196|NCT00601523|E2|Reported Event|Patients From 248.636|Patients who had previously completed 248.636 (NCT00558025)
408197|NCT00601523|E1|Reported Event|Patients From 248.524|Patients who had previously completed 248.524 (NCT00479401)
408198|NCT00601458|B4|Baseline|Total|Total of all reporting groups
408199|NCT00601458|B3|Baseline|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
408200|NCT00601458|B2|Baseline|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
408201|NCT00601458|B1|Baseline|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
408202|NCT00601458|P3|Participant Flow|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
408203|NCT00601458|P2|Participant Flow|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
408204|NCT00601458|P1|Participant Flow|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
408205|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
408206|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
408207|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
408208|NCT00601458|O3|Outcome|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
408209|NCT00601458|O2|Outcome|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
408210|NCT00601458|O1|Outcome|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
408211|NCT00601458|E3|Reported Event|Placebo|Placebo treatment was administered approximately 1 hour prior to surgery. Postoperatively, placebo was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0.
408212|NCT00601458|E2|Reported Event|Naproxen Sodium 550 mg|"Active Comparator: Arm 2: Naproxen sodium 550 mg~Naproxen sodium (550 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, naproxen sodium was dosed starting at 12 hours following T=0 and every 12 hours until 36 hours following T=0."
408213|NCT00601458|E1|Reported Event|Pregabalin 300 mg|"Active Comparator: Arm 1: Pregabalin 300 mg~Pregabalin (300 mg) treatment was administered approximately 1 hour prior to surgery. Postoperatively, pregabalin (150 mg) was dosed starting at 8 hours following T=0 and every 8 hours until 40 hours following T=0."
408214|NCT00601419|B1|Baseline|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408215|NCT00601419|P1|Participant Flow|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408216|NCT00601419|O2|Outcome|Participants Without ACTH Deficiency|Participants without ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408217|NCT00601419|O1|Outcome|Participants With ACTH Deficiency|Participants with ACTH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408218|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408219|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408220|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408221|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age while taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408222|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408223|NCT00601419|O4|Outcome|>0.084 mg/kg/Week|Participants taking an initial dose of more than 0.084 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
408224|NCT00601419|O3|Outcome|>=0.042 mg/kg/Week and <=0.084 mg/kg/Week|Participants taking an initial dose of 0.042 mg/kg/week or more and 0.084 mg/kg/week or less of somatropin for adult growth hormone deficiency according to Japanese package insert.
408225|NCT00601419|O2|Outcome|>=0.021 mg/kg/Week and <0.042 mg/kg/Week|Participants taking an initial dose of 0.021 mg/kg/week or more and less than 0.042 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
408226|NCT00601419|O1|Outcome|<0.021 mg/kg/Week|Participants taking an initial dose of less than 0.021 mg/kg/week of somatropin for adult growth hormone deficiency according to Japanese package insert.
408227|NCT00601419|O2|Outcome|Participants Without Past History of Any Disease|Participants without past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408228|NCT00601419|O1|Outcome|Participants With Past History of Any Disease|Participants with past history of any disease taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408229|NCT00601419|O2|Outcome|Participants Without TSH Deficiency|Participants without TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408230|NCT00601419|O1|Outcome|Participants With TSH Deficiency|Participants with TSH deficiency taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408231|NCT00601419|O2|Outcome|Female|Female participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408232|NCT00601419|O1|Outcome|Male|Male participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408233|NCT00601419|O2|Outcome|>=65 Years|Participants older than or equal to 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408234|NCT00601419|O1|Outcome|<65 Years|Participants younger than 65 years of age when taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408235|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408236|NCT00601419|O1|Outcome|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408237|NCT00601419|E1|Reported Event|Somatropin|Participants taking somatropin for adult growth hormone deficiency according to Japanese package insert.
408238|NCT00601367|B1|Baseline|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient.~Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site.~flibanserin flexible dose: Initial dosage: Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the pati"
408239|NCT00601367|P1|Participant Flow|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 for safety/tolerability or later in the study at any time following patient contact with the site."
408240|NCT00601367|O1|Outcome|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations: Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
408241|NCT00601367|E1|Reported Event|Flibanserin Flexible Dose|"Initial dosage:~Patients were to take one 50 mg flibanserin tablet in the evening.~Subsequent dosage titrations:~Flibanserin may have been titrated to 25 mg flibanserin b.i.d at Week 1 (Visit 2) for safety/tolerability ONLY, as determined by the clinician and given feedback from the patient. Flibanserin may have been up-titrated (higher daily dose) at week 4 (Visit 3) if efficacy was unsatisfactory or later in the study at a scheduled face-to-face office visit ONLY. Flibanserin may have been down-titrated (lower daily dose or b.i.d. regimen) at week 4 (visit 3) for safety/tolerability or later in the study at any time following patient contact with the site."
408242|NCT00601354|B3|Baseline|Total|Total of all reporting groups
408243|NCT00601354|B2|Baseline|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408244|NCT00601354|B1|Baseline|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408245|NCT00601354|P2|Participant Flow|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408246|NCT00601354|P1|Participant Flow|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408247|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408248|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408249|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408250|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408251|NCT00601354|O2|Outcome|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408252|NCT00601354|O1|Outcome|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408253|NCT00601354|E2|Reported Event|OTC Orlistat /Medication Management Alone|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program alone
408254|NCT00601354|E1|Reported Event|OTC Orlistat + Guided Self-help Affect Regulation|Group taking the weight loss medication orlistat (alli), in conjunction with the alli weight loss program, plus 12 weekly sessions of guided self-help group psychotherapy
408255|NCT00601250|B3|Baseline|Total|Total of all reporting groups
408256|NCT00601250|B2|Baseline|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408257|NCT00601250|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
408258|NCT00601250|P2|Participant Flow|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408259|NCT00601250|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
408260|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408261|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408262|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408263|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408264|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408265|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408266|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408267|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408268|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408269|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408270|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408271|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408272|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408273|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408274|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408275|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408276|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408277|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408278|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408279|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408280|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408281|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408282|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408283|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408284|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408285|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408286|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408287|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408288|NCT00601250|O2|Outcome|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408289|NCT00601250|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
408290|NCT00601250|E2|Reported Event|Linagliptin|Patients randomized to receive treatment with Linagliptin 5 mg
408291|NCT00601250|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
408292|NCT00601146|B1|Baseline|Low-dose CT Screening|Annual low-dose chest CT screening
408293|NCT00601146|P1|Participant Flow|Low-dose CT Screening|Annual low-dose chest CT screening
408294|NCT00601146|O1|Outcome|Low-dose CT Screening|Annual low-dose chest CT screening
408295|NCT00601146|E1|Reported Event|Low-dose CT Screening|Annual low-dose chest CT screening
408296|NCT00601107|B5|Baseline|Total|Total of all reporting groups
408297|NCT00601107|B4|Baseline|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408298|NCT00601107|B3|Baseline|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408299|NCT00601107|B2|Baseline|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408300|NCT00601107|B1|Baseline|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408301|NCT00601107|P4|Participant Flow|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408302|NCT00601107|P3|Participant Flow|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408303|NCT00601107|P2|Participant Flow|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408304|NCT00601107|P1|Participant Flow|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408305|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408306|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408307|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408308|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408309|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408310|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408311|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408312|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408313|NCT00601107|O4|Outcome|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408314|NCT00601107|O3|Outcome|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408315|NCT00601107|O2|Outcome|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408316|NCT00601107|O1|Outcome|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408317|NCT00601107|E4|Reported Event|Doxercalciferol 7.5 mcg/Day|Doxercalciferol 7.5 mcg capsules orally once daily up to Week 24.
408318|NCT00601107|E3|Reported Event|Doxercalciferol 5 mcg/Day|Doxercalciferol 5 mcg capsules orally once daily up to Week 24.
408319|NCT00601107|E2|Reported Event|Doxercalciferol 2.5 mcg/Day|Doxercalciferol 2.5 microgram (mcg) capsule orally once daily up to Week 24.
408320|NCT00601107|E1|Reported Event|Placebo|Placebo matching to doxercalciferol capsules orally once daily up to Week 24.
408321|NCT00600938|B3|Baseline|Total|Total of all reporting groups
408322|NCT00600938|B2|Baseline|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408323|NCT00600938|B1|Baseline|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408324|NCT00600938|P4|Participant Flow|ICL to DFO (Deferasirox to Deferoxamine)|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408325|NCT00600938|P3|Participant Flow|DFO to ICL (Deferoxamine to Deferasirox)|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408326|NCT00600938|P2|Participant Flow|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408327|NCT00600938|P1|Participant Flow|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408328|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408329|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408330|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408331|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408332|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408333|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408334|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408335|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408336|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408337|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408338|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408339|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408340|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408341|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408342|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408343|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408344|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408345|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408346|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408347|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408348|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408349|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408350|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408351|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408352|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408353|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408354|NCT00600938|O3|Outcome|Extension: DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408355|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408356|NCT00600938|O1|Outcome|Extension: ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408357|NCT00600938|O4|Outcome|Extension: ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408358|NCT00600938|O3|Outcome|Extension; DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408359|NCT00600938|O2|Outcome|Extension: DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408360|NCT00600938|O1|Outcome|Extension : ICL to ICL|Patients from core continued and received same dose 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408361|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408362|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408363|NCT00600938|O1|Outcome|Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408364|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408365|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408366|NCT00600938|O2|Outcome|Core; Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408367|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408368|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408369|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408370|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408371|NCT00600938|O1|Outcome|Core; Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408372|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408373|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408374|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408375|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408376|NCT00600938|O2|Outcome|Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
416044|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
408377|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408378|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO). For Extension Labeled as DFO to DFO|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 month
408379|NCT00600938|O1|Outcome|Core: Deferasirox (ICL). For Extension Labeled as ICL to ICL|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 month
408380|NCT00600938|O2|Outcome|Core: Deferoxamine (DFO)|50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week for 12 months.
408381|NCT00600938|O1|Outcome|Core: Deferasirox (ICL)|20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day for 12 months.
408382|NCT00600938|E6|Reported Event|Extension Phase - ICL to DFO|ICL to DFO” (patients who switched from deferasirox to DFO in extension)
408383|NCT00600938|E5|Reported Event|Extension Phase - DFO to ICL|DFO to ICL” (patients who switched from DFO to deferasirox in extension)
408384|NCT00600938|E4|Reported Event|Extension Phase - DFO to DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408385|NCT00600938|E3|Reported Event|Extension Phase - ICL to ICL|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408386|NCT00600938|E2|Reported Event|Core Phase - DFO|Patients from core continued and received same 50 mg/kg/day to 60 mg/kg/day infused subcutaneously in 8- to 12-hour intervals administered 5 to 7 days/week
408387|NCT00600938|E1|Reported Event|Core Phase - ICL670|Patients from core continued and received same 20 mg/kg/day once daily (od) for 2 weeks, followed by 30 mg/kg/day od for 1 week and a subsequent continuation of 40 mg/kg/day
408388|NCT00600886|B3|Baseline|Total|Total of all reporting groups
408389|NCT00600886|B2|Baseline|Octreotide LAR up to 26 Months|Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
408390|NCT00600886|B1|Baseline|Paseriotide LAR|Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR or Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
408391|NCT00600886|P2|Participant Flow|Octreotide LAR (Core) Followed by Pasireotide LAR (Extension)|Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
408392|NCT00600886|P1|Participant Flow|Pasireotide LAR up to 26 Months|Patients in this arm received Pasireotide LAR 40 mg im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR ) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator. Dose could be down- or up-titrated to 20 or 60 mg, respectively.
408393|NCT00600886|O2|Outcome|Octreotide LAR up to 26 Months|Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
408394|NCT00600886|O1|Outcome|Paseriotide LAR|Patients in this arm received Octreotide LAR 20 im depot injection, blinded, once every 28 days (± 2 days) for 12 months. Patients who did not respond to their randomized treatment (i.e. Pasireotide LAR or Octreotide LAR) at the end of the core (Month 12) were allowed to switch to receive the other treatment in the extension, and those who were responders continued with the same treatment as in the core at the discretion of the investigator (up to 2 years of treatment). Dose could be down- or up-titrated to 10 or 30 mg, respectively.
408395|NCT00600886|E4|Reported Event|Crossover to Octreotide LAR|Crossover to Octreotide LAR
408396|NCT00600886|E3|Reported Event|Crossover to Pasireotide LAR|Crossover to Pasireotide LAR
408397|NCT00600886|E2|Reported Event|Octreotide LAR|Octreotide LAR
408398|NCT00600886|E1|Reported Event|Pasireotide LAR|Pasireotide LAR
408399|NCT00600821|B3|Baseline|Total|Total of all reporting groups
408400|NCT00600821|B2|Baseline|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408401|NCT00600821|B1|Baseline|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408453|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408454|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408402|NCT00600821|P2|Participant Flow|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kilogram (mg/kg) infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408403|NCT00600821|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 milligram (mg) tablet administered orally twice daily (BID) along with infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin area under the concentration-time curve (AUC) of 6 mg*minute/milliliter (mg*min/mL) infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408404|NCT00600821|O2|Outcome|Bevacizumab+ Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
408405|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive Axitinib (AG-013736) BID maintenance therapy.
408406|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408407|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408408|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408409|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408410|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408411|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408412|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408413|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408414|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408415|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408416|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408417|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408455|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408456|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408418|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408419|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408420|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408421|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408422|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408423|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408424|NCT00600821|O2|Outcome|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408425|NCT00600821|O1|Outcome|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408426|NCT00600821|E2|Reported Event|Bevacizumab + Paclitaxel + Carboplatin|Bevacizumab 15 mg/kg infusion over 90 minutes every 3 weeks along with infusion of paclitaxel 200 mg/m^2 over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive bevacizumab maintenance therapy every 3 weeks.
408427|NCT00600821|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin|Axitinib (AG-013736) 5 mg tablet administered orally BID along with IV infusion of paclitaxel 200 mg per square meter (mg/m^2) over 3 hours and carboplatin AUC of 6 mg*min/mL infusion over 30 minutes in cycles of 3 weeks. After completion or discontinuation of treatment for reasons other than disease progression, participants continued to receive axitinib (AG-013736) BID maintenance therapy.
408428|NCT00600756|B3|Baseline|Total|Total of all reporting groups
408429|NCT00600756|B2|Baseline|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
408430|NCT00600756|B1|Baseline|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408431|NCT00600756|P2|Participant Flow|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
408432|NCT00600756|P1|Participant Flow|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408433|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408434|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408435|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408436|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408437|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408438|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408439|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408440|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408441|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408442|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408443|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408444|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408445|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408446|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408447|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408448|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408449|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408450|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408451|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408452|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408457|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408458|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408459|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408460|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408461|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408462|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408463|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408464|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408465|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408466|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408467|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408468|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408469|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408470|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408471|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408472|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408473|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408474|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408475|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408476|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408477|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408478|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408479|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408480|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408481|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408482|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408483|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408484|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408485|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408486|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408487|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408488|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408489|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408490|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408491|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408492|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408493|NCT00600756|O2|Outcome|Risperidone|Active Comparator - oral, once daily, tablets of 2 mg to 6 mg
408494|NCT00600756|O1|Outcome|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408495|NCT00600756|E2|Reported Event|Risperidone|Active Comparator – oral, once daily, tablets of 2 mg to 6 mg
408496|NCT00600756|E1|Reported Event|Quetiapine XR|Experimental - oral, once daily, tablets of 400 mg to 800 mg
408497|NCT00600704|B3|Baseline|Total|Total of all reporting groups
408498|NCT00600704|B2|Baseline|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
408499|NCT00600704|B1|Baseline|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
408500|NCT00600704|P2|Participant Flow|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
408501|NCT00600704|P1|Participant Flow|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
408502|NCT00600704|O2|Outcome|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
408503|NCT00600704|O1|Outcome|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
408504|NCT00600704|E2|Reported Event|FREE FLUIDS|Free fluid infusion unless Hb< 6g/dl(allogenic blood use)
408505|NCT00600704|E1|Reported Event|RESTRICTED FLUIDS|Infusion of Hes 130/0.4 up to 500 ml
408506|NCT00600613|B1|Baseline|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
408507|NCT00600613|P1|Participant Flow|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
408508|NCT00600613|O1|Outcome|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
408509|NCT00600613|E1|Reported Event|Patients Going for Treatment of Liver Metastases With RT|Patients going for treatment of liver metastases with radiation therapy.
408510|NCT00600171|B7|Baseline|Total|Total of all reporting groups
408511|NCT00600171|B6|Baseline|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408512|NCT00600171|B5|Baseline|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
416045|NCT00577135|O4|Outcome|High Intensification|
408513|NCT00600171|B4|Baseline|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408514|NCT00600171|B3|Baseline|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408515|NCT00600171|B2|Baseline|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408516|NCT00600171|B1|Baseline|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408517|NCT00600171|P6|Participant Flow|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408518|NCT00600171|P5|Participant Flow|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408519|NCT00600171|P4|Participant Flow|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408520|NCT00600171|P3|Participant Flow|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408521|NCT00600171|P2|Participant Flow|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408522|NCT00600171|P1|Participant Flow|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408523|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408524|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408525|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408526|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408527|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408528|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408529|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408530|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408531|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408532|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408605|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408606|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408533|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408534|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408535|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408536|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408537|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408538|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408539|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408540|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408541|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408542|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408543|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408544|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408545|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408546|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408547|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408548|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408549|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408550|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408551|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408552|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408607|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408608|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408609|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408553|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408554|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408555|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408556|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408557|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408558|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408559|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408560|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408561|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408562|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408563|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408564|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408565|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408566|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408567|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408568|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408569|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408570|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408571|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408572|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408610|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408611|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408612|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408573|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µgon non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408574|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408575|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408576|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408577|NCT00600171|O6|Outcome|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408578|NCT00600171|O5|Outcome|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408579|NCT00600171|O4|Outcome|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408580|NCT00600171|O3|Outcome|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408581|NCT00600171|O2|Outcome|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408582|NCT00600171|O1|Outcome|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408583|NCT00600171|E6|Reported Event|GW642444M 50 µg|Particpants received GW642444M 50 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 50 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408584|NCT00600171|E5|Reported Event|GW642444M 25 µg|Particpants received GW642444M 25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408585|NCT00600171|E4|Reported Event|GW642444M 12.5 µg|Particpants received GW642444M 12.5 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 12.5 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408586|NCT00600171|E3|Reported Event|GW642444M 6.25 µg|Particpants received GW642444M 6.25 µg at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 6.25 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408587|NCT00600171|E2|Reported Event|GW642444M 3 µg|Particpants received GW642444M 3 micrograms (µg) at the clinic on Days 1, 7, 14, and 28, and self administered GW642444M 3 µg on non-clinic study days, once daily in the evening via the DPI. Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408588|NCT00600171|E1|Reported Event|Placebo|Particpants received placebo at the clinic on Days 1 7, 14, and 28, and self-administered placebo on non-clinic study days, once daily in the evening via the Dry Powder Inhaler (DPI). Participants remained on their current ICS therapy (at fixed doses) throughout the study (screening to follow-up inclusive).
408589|NCT00600119|B7|Baseline|Total|Total of all reporting groups
408590|NCT00600119|B6|Baseline|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408591|NCT00600119|B5|Baseline|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408592|NCT00600119|B4|Baseline|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408593|NCT00600119|B3|Baseline|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408594|NCT00600119|B2|Baseline|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408595|NCT00600119|B1|Baseline|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408596|NCT00600119|P6|Participant Flow|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408597|NCT00600119|P5|Participant Flow|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408598|NCT00600119|P4|Participant Flow|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408599|NCT00600119|P3|Participant Flow|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408600|NCT00600119|P2|Participant Flow|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408601|NCT00600119|P1|Participant Flow|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408602|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408603|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408604|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408613|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408614|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408615|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408616|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408617|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408618|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408619|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408620|NCT00600119|O6|Outcome|NKTR-118 50 mg|NKTR-118 50 mg QD, oral treatment
408621|NCT00600119|O5|Outcome|Placebo 50 mg|Placebo for NKTR-118 50 mg QD, oral treatment
408622|NCT00600119|O4|Outcome|NKTR-118 25 mg|NKTR-118 25 mg QD, oral treatment
408623|NCT00600119|O3|Outcome|Placebo 25 mg|Placebo for NKTR-118 25 mg QD, oral treatment
408624|NCT00600119|O2|Outcome|NKTR-118 5 mg|NKTR-118 5 mg QD, oral treatment
408625|NCT00600119|O1|Outcome|Placebo 5 mg|Placebo for NKTR-118 5 mg QD, oral treatment
408626|NCT00600119|E6|Reported Event|Placebo 50 mg|
408627|NCT00600119|E5|Reported Event|Placebo 5 mg|
408628|NCT00600119|E4|Reported Event|Placebo 25 mg|
408629|NCT00600119|E3|Reported Event|NKTR-118 50 mg|
408630|NCT00600119|E2|Reported Event|NKTR-118 5 mg|
408631|NCT00600119|E1|Reported Event|NKTR-118 25 mg|
408632|NCT00600080|B1|Baseline|All Subjects|All subjects crossed over to use each treatment for one week
408633|NCT00600080|P2|Participant Flow|Nelfilcon A/Etafilcon A|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2.
408634|NCT00600080|P1|Participant Flow|Etafilcon A/Nelfilcon A|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2.
408635|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
408636|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
408637|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
408638|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
408639|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
408640|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
408641|NCT00600080|O2|Outcome|Etafilcon A|All subjects who wore etafilcon A lenses for one week
408642|NCT00600080|O1|Outcome|Nelfilcon A|All subjects who wore nelfilcon A lenses for one week
408643|NCT00600080|E2|Reported Event|Nelfilcon A First Etafilcon A Second|nelfilcon A worn daily during week 1, etafilcon A worn daily for week 2
408644|NCT00600080|E1|Reported Event|Etafilcon A First Nelfilcon A Second|etafilcon A worn daily during week 1, nelfilcon A worn daily for week 2
408645|NCT00600067|B3|Baseline|Total|Total of all reporting groups
408646|NCT00600067|B2|Baseline|Active|PHEN/TPM 15/92
408647|NCT00600067|B1|Baseline|Placebo|
408648|NCT00600067|P2|Participant Flow|VI-0521|phentermine 15 mg/topiramate 92 mg
408649|NCT00600067|P1|Participant Flow|Placebo|
408650|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92mg
408651|NCT00600067|O1|Outcome|Placebo|
408652|NCT00600067|O2|Outcome|VI-0521|phentermine 15mg/topiramate 92 mg
408653|NCT00600067|O1|Outcome|Placebo|
408654|NCT00600067|E2|Reported Event|Active|PHEN/TPM 15/92
408655|NCT00600067|E1|Reported Event|Placebo|
408656|NCT00600015|B3|Baseline|Total|Total of all reporting groups
408657|NCT00600015|B2|Baseline|Placebo|Erlotinib + Placebo
408658|NCT00600015|B1|Baseline|Combination Therapy|Erlotinib + Sorafenib
408659|NCT00600015|P2|Participant Flow|Placebo|Erlotinib + Placebo
408660|NCT00600015|P1|Participant Flow|Combination Therapy|Erlotinib + Sorafenib
408661|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
408662|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
408663|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
408664|NCT00600015|O2|Outcome|Placebo|Erlotinib + Placebo
408665|NCT00600015|O1|Outcome|Combination Therapy|Erlotinib + Sorafenib
408666|NCT00600015|E1|Reported Event|All Study Participants|"Reported SAEs and AEs for all study participants -~Combination Therapy: Erlotinib + Sorafenib Placebo: Erlotinib + Placebo"
408667|NCT00599924|B8|Baseline|Total|Total of all reporting groups
408668|NCT00599924|B7|Baseline|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408669|NCT00599924|B6|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408670|NCT00599924|B5|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408671|NCT00599924|B4|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408672|NCT00599924|B3|Baseline|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408673|NCT00599924|B2|Baseline|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408674|NCT00599924|B1|Baseline|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408675|NCT00599924|P7|Participant Flow|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408676|NCT00599924|P6|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408677|NCT00599924|P5|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408678|NCT00599924|P4|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408679|NCT00599924|P3|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408680|NCT00599924|P2|Participant Flow|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408681|NCT00599924|P1|Participant Flow|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408682|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
408683|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
408684|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408685|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408686|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408687|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
408688|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week rest period, overlapping with 3 cycles of modified FOLFOX6
408689|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408690|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408691|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408692|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408693|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408694|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408695|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408696|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408697|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408698|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408699|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408700|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408701|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408702|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408703|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408704|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
409370|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
408705|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408706|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408707|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408708|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408709|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408710|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408711|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408712|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408713|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408714|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408715|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408716|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408717|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408718|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408719|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408720|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408721|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408722|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408723|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408724|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408725|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408726|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408727|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408728|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408729|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408730|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408731|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408732|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408733|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
409371|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
408734|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408735|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408736|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408737|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408738|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408739|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408740|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408741|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408742|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408743|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week rest period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408744|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408745|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408746|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408747|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408748|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408749|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408750|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408751|NCT00599924|O7|Outcome|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408752|NCT00599924|O6|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408753|NCT00599924|O5|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408754|NCT00599924|O4|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408755|NCT00599924|O3|Outcome|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408756|NCT00599924|O2|Outcome|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408757|NCT00599924|O1|Outcome|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408758|NCT00599924|E7|Reported Event|25 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408759|NCT00599924|E6|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Continuous Dosing)|Continuous Dosing = Sunitinib administered daily for 16 weeks. Off periods and dosage depended on toxicities observed. Sunitinib was administered with modified FOLFOX6.
408760|NCT00599924|E5|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408761|NCT00599924|E4|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 4/2)|Schedule 4/2 = Sunitinib administered daily for 4 weeks followed by a 2-week off period, overlapping with 3 cycles of modified FOLFOX6
408762|NCT00599924|E3|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (CRC Only, Schedule 2/2)|CRC = colorectal cancer. Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
409372|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
408763|NCT00599924|E2|Reported Event|50 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408764|NCT00599924|E1|Reported Event|37.5 mg Sunitinib + Modified FOLFOX6 (Schedule 2/2)|Schedule 2/2 = Sunitinib administered daily for 2 weeks followed by a 2-week off period. Sunitinib was administered during every other cycle of modified FOLFOX6.
408765|NCT00599872|B3|Baseline|Total|Total of all reporting groups
408766|NCT00599872|B2|Baseline|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408767|NCT00599872|B1|Baseline|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
408768|NCT00599872|P2|Participant Flow|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408769|NCT00599872|P1|Participant Flow|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
408770|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408771|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
408772|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408773|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
408774|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408775|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 77.3 Units/Amb a 1.
408776|NCT00599872|O2|Outcome|Placebo|"Standardized Ragweed Allergenic Extract Placebo via the sublingual oral route~Placebo: Placebo, sublingual oral"
408777|NCT00599872|O1|Outcome|Ragweed Allergenic Extract|"Standardized Ragweed Allergenic Extract administered via the sublingual oral route (27.6 to 77.3 Amb a 1 Units)~Standardized Ragweed Allergenic Extract: Standardized Ragweed Allergenic Extract, sublingual oral"
408778|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408779|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 27.6 to 77.3 Units/Amb a 1.
408780|NCT00599872|O2|Outcome|Placebo|Placebo to be administered once daily at 0.0 Units/Amb a 1
408781|NCT00599872|O1|Outcome|Active|Ragweed allergenic extract administer once daily at 26.3 to 77.3 Units/Amb a 1.
408782|NCT00599872|E2|Reported Event|Placebo|Placebo be administered once daily at 0.0 Units/Amb a 1
408783|NCT00599872|E1|Reported Event|Ragweed Allergenic Extract|Ragweed Allergenic extract administered once daily at 77.3 Units/Amb a 1.
408784|NCT00599755|B1|Baseline|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408785|NCT00599755|P1|Participant Flow|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408786|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408787|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408788|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408789|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408790|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408791|NCT00599755|O1|Outcome|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408792|NCT00599755|E1|Reported Event|Gemcitabine and Cisplatin or Gemcitabine and Carboplatin|Tumor uptake of FDG is imaged by PET both before and after combination chemotherapy with Gem/Cis or Gem/Carbo
408793|NCT00599521|B3|Baseline|Total|Total of all reporting groups
408794|NCT00599521|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408795|NCT00599521|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
408796|NCT00599521|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408797|NCT00599521|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
408798|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408799|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408800|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408801|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408802|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408803|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408804|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408805|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408806|NCT00599521|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408807|NCT00599521|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408808|NCT00599521|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408809|NCT00599521|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
408810|NCT00599339|B1|Baseline|Overall|For this study, 5 groups of patients with different Parkinson’s disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
408976|NCT00599014|P1|Participant Flow|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
408811|NCT00599339|P1|Participant Flow|Overall|For this study, 5 groups of patients with different Parkinson's disease treatments were to be considered. Initial treatments were to include dopaminergic monotherapy with rotigotine, other dopamine agonists (eg, pramipexole, cabergoline, ropinirole), or L-dopa, treatment with L-dopa combined with rotigotine or other dopamine agonists. Treatment was to be performed according to standard medical practice. Patients were to be given a treatment for Parkinson's disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.
408812|NCT00599339|O2|Outcome|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
408813|NCT00599339|O1|Outcome|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
408814|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408815|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408816|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408817|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408818|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408819|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408820|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408821|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408822|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408823|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408824|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408825|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408826|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408827|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408828|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408829|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408830|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408831|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408832|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408833|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408834|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408835|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408836|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408837|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408838|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408839|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408840|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408841|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408842|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408977|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
408843|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408844|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408845|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408846|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408847|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408848|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408849|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408850|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408851|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408852|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408853|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408854|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408855|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408856|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408857|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408858|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408978|NCT00599014|O1|Outcome|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
408859|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408860|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408861|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408862|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408863|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408864|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408865|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408866|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408867|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408868|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408869|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408870|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408871|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408872|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408873|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408874|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408979|NCT00599014|E1|Reported Event|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
408875|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408876|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408877|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408878|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408879|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408880|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408881|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408882|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408883|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408884|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408885|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408886|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408887|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408888|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408889|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408890|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408980|NCT00598871|B3|Baseline|Total|Total of all reporting groups
409373|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
408891|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408892|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408893|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408894|NCT00599339|O16|Outcome|Not Treated (< 3 Months)|"This group shows all subjects which were not treated for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408895|NCT00599339|O15|Outcome|Not Treated (>= 3 Months)|"This group shows all subjects which were not treated for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily not treated at Baseline."
408896|NCT00599339|O14|Outcome|Multiple Dopamine Agonists + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408897|NCT00599339|O13|Outcome|Multiple Dopamine Agonists + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists and L-Dopa at Baseline."
408898|NCT00599339|O12|Outcome|Other Dopamine Agonist + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408899|NCT00599339|O11|Outcome|Other Dopamine Agonist + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist and L-Dopa at Baseline."
408900|NCT00599339|O10|Outcome|Neupro + L-Dopa (< 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408901|NCT00599339|O9|Outcome|Neupro + L-Dopa (>= 3 Months)|"This group shows all subjects which were treated with Neupro and L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro and L-Dopa at Baseline."
408902|NCT00599339|O8|Outcome|Multiple Dopamine Agonists (< 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408903|NCT00599339|O7|Outcome|Multiple Dopamine Agonists (>= 3 Months)|"This group shows all subjects which were treated with multiple dopamine agonists for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with multiple dopamine agonists at Baseline."
408904|NCT00599339|O6|Outcome|L-Dopa Monotherapy (< 3 Months)|"This group shows all subjects which were treated with L-Dopa for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408905|NCT00599339|O5|Outcome|L-Dopa Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with L-Dopa for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with L-Dopa at Baseline."
408906|NCT00599339|O4|Outcome|Other Dopamine Agonist (< 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
409080|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
408907|NCT00599339|O3|Outcome|Other Dopamine Agonist (>= 3 Months)|"This group shows all subjects which were treated with other dopamine agonist for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with other dopamine agonist at Baseline."
408908|NCT00599339|O2|Outcome|Neupro Monotherapy (< 3 Months)|"This group shows all subjects which were treated with Neupro for less than 3 months at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408909|NCT00599339|O1|Outcome|Neupro Monotherapy (>= 3 Months)|"This group shows all subjects which were treated with Neupro for 3 months or more at Visit 7. Patients were to be given a treatment for Parkinson’s disease deemed appropriate by the physician, and the treatment could be modified by the physician at any time during the study.~Thus, subjects presented in this group weren't necessarily treated with Neupro at Baseline."
408910|NCT00599339|E2|Reported Event|Not Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) not associated with Rotigotine only if during the study he was at risk to develop an AE not associated with Rotigotine.~An adverse event was considered not to be associated with Rotigotine, if no Rotigotine was administered in the 30 days period prior to the onset of the AE."
408911|NCT00599339|E1|Reported Event|Associated With Rotigotine|"A patient was analyzed related to Adverse Events (AEs) associated with Rotigotine only if during the study he was at risk to develop an AE associated with Rotigotine.~An Adverse Event was considered to be associated with Rotigotine if Rotigotine was administered at least once within 30 days prior to the onset of the adverse event. Associated Event does not necessarily mean related to treatment with Rotigotine."
408912|NCT00599326|B1|Baseline|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
408913|NCT00599326|P1|Participant Flow|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
408914|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
408915|NCT00599326|O1|Outcome|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
408916|NCT00599326|E1|Reported Event|Deferasirox|Deferasirox : 250 mg of deferasirox once daily for 6 months with an increase to 500 mg/d after 2 months if new blisters continued to develop.
408917|NCT00599313|B1|Baseline|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408918|NCT00599313|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408919|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408920|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408921|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408922|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408923|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408924|NCT00599313|O1|Outcome|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408925|NCT00599313|E1|Reported Event|Sunitinib Malate|Sunitinib Malate (Sutent) (50 mg/day on Days 1-28 of 42-day cycles)
408926|NCT00599248|B3|Baseline|Total|Total of all reporting groups
408927|NCT00599248|B2|Baseline|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
408928|NCT00599248|B1|Baseline|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
408929|NCT00599248|P2|Participant Flow|Plcebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
408930|NCT00599248|P1|Participant Flow|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
408931|NCT00599248|O2|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
408932|NCT00599248|O1|Outcome|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
408933|NCT00599248|O2|Outcome|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
408934|NCT00599248|O1|Outcome|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
408935|NCT00599248|E2|Reported Event|Placebo Control (DMEM)|"Placebo control~Placebo: Placebo control (DMEM)"
408936|NCT00599248|E1|Reported Event|Active Treatment (TG-C)|"TissueGene-C at 3x10e6, 1x10e7 or, 3x10e7 cells/joint~TissueGene-C: TissueGene-C at 3x10e6, 1x10e7 or 3x10e7 cells/joint to be administered by intra-articular injection"
408937|NCT00599196|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
408938|NCT00599196|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
408939|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
408940|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
409374|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409375|NCT00597428|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
408941|NCT00599196|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
408942|NCT00599196|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 8 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
408943|NCT00599131|B1|Baseline|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408944|NCT00599131|P1|Participant Flow|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408945|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408946|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408947|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408948|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408949|NCT00599131|O1|Outcome|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408950|NCT00599131|E1|Reported Event|Chemotherapy/Radiation/Surgery|"Patients will undergo induction chemotherapy with (TPF): Docetaxel (Taxotere) 75 mg/m2 and cisplatin 100 mg/m2 on day 1, and 5-FU 750 mg/m2 days 1-4.~On day 20 patients will receive a single dose of cetuximab (C-225) 400 mg/m2.~Depending upon disease response, patients will undergo salvage laryngectomy followed by radiation therapy and chemotherapy."
408951|NCT00599053|B3|Baseline|Total|Total of all reporting groups
408952|NCT00599053|B2|Baseline|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408953|NCT00599053|B1|Baseline|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408954|NCT00599053|P2|Participant Flow|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408955|NCT00599053|P1|Participant Flow|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408956|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408957|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408958|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408959|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408960|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408961|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408962|NCT00599053|O2|Outcome|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408963|NCT00599053|O1|Outcome|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408964|NCT00599053|E2|Reported Event|Expectant (Usual) Management|Intervention at the discretion of the attending physician
408965|NCT00599053|E1|Reported Event|Early Treatment With Azithromycin|Azithromycin (10mg/kg/day) start < 72 hours of age for 10 days
408966|NCT00599027|B3|Baseline|Total|Total of all reporting groups
408967|NCT00599027|B2|Baseline|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
408968|NCT00599027|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
408969|NCT00599027|P2|Participant Flow|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
408970|NCT00599027|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
408971|NCT00599027|O2|Outcome|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
408972|NCT00599027|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
408973|NCT00599027|E2|Reported Event|Placebo Nasal Spray|Placebo nasal spray once daily (two puffs per nostril) in the morning.
408974|NCT00599027|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone furoate nasal spray (MFNS) 200 mcg once daily (two 50 mcg puffs per nostril) in the morning.
408975|NCT00599014|B1|Baseline|Patients With Heart Failure|All stable patients with heart failure willing to participate were enrolled to be followed-up for 5 years
416046|NCT00577135|O3|Outcome|Low Intensification|
408981|NCT00598871|B2|Baseline|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408982|NCT00598871|B1|Baseline|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408983|NCT00598871|P2|Participant Flow|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408984|NCT00598871|P1|Participant Flow|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408985|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408986|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408987|NCT00598871|O2|Outcome|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408988|NCT00598871|O1|Outcome|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408989|NCT00598871|E2|Reported Event|Active Drug|Administration of 0.01% Tβ4 weight/weight (w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408990|NCT00598871|E1|Reported Event|Placebo|Administration of 0.00% Thymosin beta 4 (Tβ4) weight/weight(w/w) eyedrops to the affected eye, 2 drops 4 times a day (breakfast, lunch, dinner, and bedtime) for 14 days. The first of 4 daily doses will be administered following surgery (vitrectomy).
408991|NCT00598832|B3|Baseline|Total|Total of all reporting groups
408992|NCT00598832|B2|Baseline|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408993|NCT00598832|B1|Baseline|Adapalene Lotion 0.1%|once a day for 12 weeks
408994|NCT00598832|P2|Participant Flow|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408995|NCT00598832|P1|Participant Flow|Adapalene Lotion 0.1%|once a day for 12 weeks
408996|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408997|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
408998|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
408999|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
409000|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
409001|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
409002|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
409003|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
409004|NCT00598832|O2|Outcome|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
409005|NCT00598832|O1|Outcome|Adapalene Lotion 0.1%|once a day for 12 weeks
409006|NCT00598832|E2|Reported Event|Adapalene Lotion Vehicle 0%|once a day for 12 weeks
409007|NCT00598832|E1|Reported Event|Adapalene Lotion 0.1%|once a day for 12 weeks
409008|NCT00598819|B1|Baseline|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409009|NCT00598819|P1|Participant Flow|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409010|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409011|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409012|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409013|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409014|NCT00598819|O1|Outcome|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409015|NCT00598819|E1|Reported Event|Healthy Volunteers|The participants were young adults (18 year-old or Older) who met the inclusion/exclusion criteria for the study and passed a physical exam. Subjects were fitted with the device, and laid down for 4 hours, sat upright for 30 minutes and rode an exercise bicycle for 30-45 minutes. The physical exam and device fitting was performed by the investigator.
409016|NCT00598702|B9|Baseline|Total|Total of all reporting groups
409017|NCT00598702|B8|Baseline|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409018|NCT00598702|B7|Baseline|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409019|NCT00598702|B6|Baseline|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409020|NCT00598702|B5|Baseline|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409021|NCT00598702|B4|Baseline|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409022|NCT00598702|B3|Baseline|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409023|NCT00598702|B2|Baseline|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409024|NCT00598702|B1|Baseline|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409025|NCT00598702|P8|Participant Flow|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409026|NCT00598702|P7|Participant Flow|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409027|NCT00598702|P6|Participant Flow|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409028|NCT00598702|P5|Participant Flow|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409029|NCT00598702|P4|Participant Flow|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409030|NCT00598702|P3|Participant Flow|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409031|NCT00598702|P2|Participant Flow|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409032|NCT00598702|P1|Participant Flow|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409033|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409034|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409035|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409036|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409037|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409038|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409039|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409040|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409041|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409042|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409043|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409044|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409045|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409046|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409376|NCT00597428|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409047|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409048|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409049|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409050|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409051|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409052|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409053|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409054|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409055|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409056|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409057|NCT00598702|O8|Outcome|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409058|NCT00598702|O7|Outcome|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409059|NCT00598702|O6|Outcome|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409060|NCT00598702|O5|Outcome|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409061|NCT00598702|O4|Outcome|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409062|NCT00598702|O3|Outcome|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409063|NCT00598702|O2|Outcome|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409064|NCT00598702|O1|Outcome|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409065|NCT00598702|E8|Reported Event|Infants (12 to < 24 Months): IV APAP 10 - 15 mg/kg q6h|Infants 12 to < 24 months who were administered 10 - 15mg/kg body weight intravenous acetaminophen solution every 6 hours
409066|NCT00598702|E7|Reported Event|Infants (12 to < 24 Months): IV APAP 6.7 - 12.5 mg/kg q4h|Infants 12 to < 24 months who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409067|NCT00598702|E6|Reported Event|Adolescents (12 to <= 16 Years Old): IV APAP 10 - 15 mg/kg q6h|Adolescents 12 to <= 16 years old who were administered 10 - 15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409068|NCT00598702|E5|Reported Event|Adolescents (12 to <= 16 Years): IV APAP 6.7 - 12.5 mg/kg q4h|Adolescents 12 to <= 16 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409069|NCT00598702|E4|Reported Event|Children (2 to < 12 Years Old): IV APAP 10 - 15 mg/kg q6h|Children 2 to < 12 years old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409070|NCT00598702|E3|Reported Event|Children (2 to < 12 Years Old): IV APAP 6.7 - 12.5 mg/kg q4h|Children 2 to < 12 years old who were administered 6.7 -12.5 mg/kg body weight intravenous acetaminophen solution every 4 hours
409071|NCT00598702|E2|Reported Event|Infants (29 Days to 1 Year Old): IV APAP 10 - 15 mg/kg q6h|Infants 29 days to 1 year old who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 6 hours
409072|NCT00598702|E1|Reported Event|Neonates (<= 28 Days Old): IV APAP 10 - 15 mg/kg q8h|Neonates 28 days or less who were administered 10 -15 mg/kg body weight intravenous acetaminophen solution every 8 hours
409073|NCT00598689|B3|Baseline|Total|Total of all reporting groups
409074|NCT00598689|B2|Baseline|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
409075|NCT00598689|B1|Baseline|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409076|NCT00598689|P2|Participant Flow|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
409077|NCT00598689|P1|Participant Flow|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409078|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
409079|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409081|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409082|NCT00598689|O2|Outcome|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
409083|NCT00598689|O1|Outcome|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409084|NCT00598689|E2|Reported Event|No Lubricant|Patients scheduled to receive LASIK surgery and randomized to receive no intervention of 0.3% hypromellose ophthalmic solution prior to surgery
409085|NCT00598689|E1|Reported Event|Lubricant|"Patients scheduled to receive LASIK surgery and randomized to receive 0.3% hypromellose ophthalmic solution prior to surgery.~0.3% hypromellose: 0.3% hypromellose four times a day for 5 days prior to LASIK surgery"
409086|NCT00598650|B1|Baseline|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
409087|NCT00598650|P1|Participant Flow|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
409088|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
409089|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
409090|NCT00598650|O2|Outcome|Placebo/E2020|Of the 104 patients of Arm 1, Arm 2 is patients from the placebo group in the preceding a 12-week, randomized, placebo-controlled trial (registered at ClinicalTrials.gov, number NCT00543855). That is to say Arm 1 consisted of 28 patients (Arm 2) from the placebo group in the preceding trial, and 76 patients from any of the E2020 group (3-mg group, 5-mg group, or 10-mg group).
409091|NCT00598650|O1|Outcome|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
409092|NCT00598650|E1|Reported Event|E2020|Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
409093|NCT00598559|B4|Baseline|Total|Total of all reporting groups
409094|NCT00598559|B3|Baseline|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
409095|NCT00598559|B2|Baseline|IV Acetaminophen 650 mg q4h|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
409096|NCT00598559|B1|Baseline|IV Acetaminophen 1g q6h|All Subjects Randomized to Receive IV acetaminophen 1g administered every 6 hours.
409097|NCT00598559|P3|Participant Flow|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
409098|NCT00598559|P2|Participant Flow|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
409099|NCT00598559|P1|Participant Flow|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
409100|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
409101|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
409102|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
409103|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
409104|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
409105|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
409106|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
409107|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
409108|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
409109|NCT00598559|O3|Outcome|Standard of Care (SOC)|mITT Population, Subjects Who Received Standard of Care Treatment.
409110|NCT00598559|O2|Outcome|IV Acetaminophen 650 mg q4h|mITT Population, IV acetaminophen 650 mg administered every 4 hours.
409111|NCT00598559|O1|Outcome|IV Acetaminophen 1 g q6h|mITT Population, IV acetaminophen 1 g administered every 6 hours.
409112|NCT00598559|E3|Reported Event|Standard of Care (SOC)|All Subjects Randomized to Receive standard of care treatment under the discretion of the Investigator and the medical staff caring for them.
409113|NCT00598559|E2|Reported Event|IV Acetaminophen 650 Milligram Every 4 Hours|All Subjects Randomized to Receive 650 mg IV acetaminophen administered every 4 hours.
409114|NCT00598559|E1|Reported Event|IV Acetaminophen 1 Gram Every 6 Hours|All Subjects Randomized to Receive IV acetaminophen 1 gram administered every 6 hours.
409115|NCT00598507|B1|Baseline|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409116|NCT00598507|P1|Participant Flow|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409117|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409118|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409119|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409120|NCT00598507|O1|Outcome|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409121|NCT00598507|E1|Reported Event|Chemotherapy - ZK-EPO|ZK-EPO (ZK 219477) (Sagopilone), 16 mg/m^2, was administered intravenously over 3-hours every 21 days until progression or unacceptable toxicity.
409122|NCT00598442|B4|Baseline|Total|Total of all reporting groups
409123|NCT00598442|B3|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409124|NCT00598442|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409125|NCT00598442|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409126|NCT00598442|P3|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409127|NCT00598442|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409128|NCT00598442|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409129|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409130|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409131|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409132|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409133|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409134|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409135|NCT00598442|O3|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409136|NCT00598442|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409137|NCT00598442|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409138|NCT00598442|E3|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa by subcutaneous injection once every 2 weeks, as prescribed. The starting dose was 0.75 microgram per kilogram (mcg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409139|NCT00598442|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409140|NCT00598442|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409141|NCT00598273|B4|Baseline|Total|Total of all reporting groups
409142|NCT00598273|B3|Baseline|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409143|NCT00598273|B2|Baseline|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409144|NCT00598273|B1|Baseline|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409398|NCT00597272|B7|Baseline|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
409145|NCT00598273|P3|Participant Flow|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409146|NCT00598273|P2|Participant Flow|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409147|NCT00598273|P1|Participant Flow|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409148|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409149|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409150|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409151|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409152|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409153|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409154|NCT00598273|O3|Outcome|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409155|NCT00598273|O2|Outcome|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409156|NCT00598273|O1|Outcome|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409157|NCT00598273|E3|Reported Event|Darbepoetin Alfa|Participants received a starting dose of 0.75 microgram per kilogram (mcg/kg) administered by subcutaneous injection once every 2 weeks, as prescribed. The dose was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409158|NCT00598273|E2|Reported Event|Peginesatide 0.04 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.04 mg/kg and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 g/dL.
409159|NCT00598273|E1|Reported Event|Peginesatide 0.025 mg/kg|Participants received peginesatide by subcutaneous injection once every 4 weeks. The starting dose was 0.025 milligram per kilogram (mg/kg) and was adjusted throughout the study to maintain a hemoglobin target range of 11.0-12.0 grams per deciliter (g/dL).
409160|NCT00598078|B1|Baseline|All Study Participants|All treated study participants
409161|NCT00598078|P2|Participant Flow|Regimen A, Then C, Then B|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2: Placebo at ~8am, ~10am, and ~12pm; Day 3: Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm;
409162|NCT00598078|P1|Participant Flow|Regimen A, Then B, Then C|Day 1: Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm; Day 2:Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm; Day 3:Placebo at ~8am, ~10am, and ~12pm
409163|NCT00598078|O3|Outcome|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
409164|NCT00598078|O2|Outcome|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
409165|NCT00598078|O1|Outcome|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
409166|NCT00598078|E3|Reported Event|Placebo (C)|Placebo at ~8am, ~10am, and ~12pm (Day 2 or 3)
409167|NCT00598078|E2|Reported Event|Sodium Oxybate 3 Grams (B)|Sodium Oxybate 1.5g at ~8am, placebo at ~10am, Sodium Oxybate 1.5g at ~12pm (Day 2 or 3)
409168|NCT00598078|E1|Reported Event|Sodium Oxybate 1.5 Grams (A)|Sodium Oxybate 0.75g at ~8am, Sodium Oxybate 0.75g at ~10am, placebo at ~12pm (Day 1 only)
409169|NCT00597909|B4|Baseline|Total|Total of all reporting groups
409170|NCT00597909|B3|Baseline|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409171|NCT00597909|B2|Baseline|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409172|NCT00597909|B1|Baseline|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409173|NCT00597909|P3|Participant Flow|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409399|NCT00597272|B6|Baseline|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409400|NCT00597272|B5|Baseline|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409174|NCT00597909|P2|Participant Flow|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409175|NCT00597909|P1|Participant Flow|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409176|NCT00597909|O3|Outcome|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409177|NCT00597909|O2|Outcome|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409178|NCT00597909|O1|Outcome|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409179|NCT00597909|E3|Reported Event|Arm 3|placebo solution (10% dextrose): Placebo solution (10% dextrose), IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409180|NCT00597909|E2|Reported Event|Arm 2|sodium phenylacetate and sodium benzoate injection 10% / 10%: 2.75 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409181|NCT00597909|E1|Reported Event|Arm 1|sodium phenylacetate and sodium benzoate injection 10% / 10%: 5.5 g/m² diluted in 10% dextrose, IV as a 2-hour loading (initial) dose, followed by the same dose over 24 hours (maintenance infusion); maintenance infusion will be continued for 3 days (70 hours)
409182|NCT00597896|B3|Baseline|Total|Total of all reporting groups
409183|NCT00597896|B2|Baseline|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409184|NCT00597896|B1|Baseline|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409185|NCT00597896|P2|Participant Flow|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409186|NCT00597896|P1|Participant Flow|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
409187|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409188|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409189|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409190|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409191|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409192|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409193|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409194|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409195|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409196|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409197|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409198|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409199|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409200|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409201|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409202|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409203|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409204|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409205|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409206|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID - pramipexole
409207|NCT00597896|O2|Outcome|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409208|NCT00597896|O1|Outcome|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
409209|NCT00597896|E2|Reported Event|Placebo Pramipexole|0.125 mg BID-0.75 mg BID - matching placebo
409210|NCT00597896|E1|Reported Event|Active Pramipexole|0.125 mg BID-0.75 mg BID pramipexole
409211|NCT00597753|B3|Baseline|Total|Total of all reporting groups
409212|NCT00597753|B2|Baseline|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409213|NCT00597753|B1|Baseline|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409214|NCT00597753|P2|Participant Flow|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409401|NCT00597272|B4|Baseline|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
409215|NCT00597753|P1|Participant Flow|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409216|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409217|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409218|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409219|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409220|NCT00597753|O2|Outcome|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409221|NCT00597753|O1|Outcome|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409222|NCT00597753|E2|Reported Event|Epoetin Alfa|Participants continued to receive commercially available epoetin alfa by intravenous injection, at the same starting dose and frequency as received during the last week of the Screening Period, with the first study dose of epoetin alfa administered after randomization at Week 0. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409223|NCT00597753|E1|Reported Event|Peginesatide|Participants received peginesatide by intravenous injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa dose. The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period.
409224|NCT00597714|B3|Baseline|Total|Total of all reporting groups
409225|NCT00597714|B2|Baseline|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409226|NCT00597714|B1|Baseline|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409252|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409402|NCT00597272|B3|Baseline|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409227|NCT00597714|P3|Participant Flow|Donor|"5-6/6 matched sibling who meets the other donor criteria is the first choice,~Matched Unrelated Donor (MUD) is the second choice*, and~3-5/6 partially matched family member (if 5/6 then this donor is not a sibling as that would be first choice) is the third choice for donor type.~Multiple choices for 3-5/6 human leukocyte antigen (HLA) matched family member donors order of choice will be best match, then cytomegalovirus (CMV) negativity, then Killer-cell immunoglobulin-like receptors (KIR) mismatching (for natural killer [NK] cell activity), then history of pregnancy. All subjects without an available matched sibling must have a donor search initiated with the national bank. If potential high resolution matches are found but not utilized, the reason for proceeding with a partially matched family member should be documented (i.e. donor not available, not enough time to allow MUD donor work up and collection due to high risk nature of the subject's disease, etc)."
409228|NCT00597714|P2|Participant Flow|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409229|NCT00597714|P1|Participant Flow|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The PBSCs will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409230|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409231|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours.The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409232|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409233|NCT00597714|O1|Outcome|Cohort A & B - Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. For the myeloid group, the prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409234|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409273|NCT00596453|E2|Reported Event|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
409274|NCT00596453|E1|Reported Event|Placebo|Placebo: Placebo twice a day for 14 days
409235|NCT00597714|O1|Outcome|Cohort A & B- Lymphoid & Myeloid Disease|Non-myeloablative Stem Cell Transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen for myeloid disease will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The Peripheral Blood Stem Cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409236|NCT00597714|E2|Reported Event|Cohort B - Myeloid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive granulocyte colony stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The prep regimen will begin on day -5 or day -4 and busulfan 130mg/m2/d for 2 days over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409237|NCT00597714|E1|Reported Event|Cohort A - Lymphoid Disease|Non-myeloablative stem cell transplant (SCT): Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily for 4 days, until pheresis is completed or until white blood cells > 100,000. Recipients will be premedicated with Benadryl 50 mg intravenously (IV) or orally (PO), and acetaminophen 650 mg PO (or hydrocortisone 50-100 mg IV on first day). The preparative regimen is 4 days of daily fludarabine at 40 mg/m2/d infused over 30 minutes; melphalan 140 mg/m2/d for 1 day administered over 15 minutes; 4 days of Alemtuzumab at 20 mg/d in 250 ml of normal saline infused over 3 hours. The peripheral blood stem cells (PBSCs) will be infused over 2-4 days. Participant evaluations will occur 2 times per week by physical exam for toxicity through day 45.
409238|NCT00597701|B3|Baseline|Total|Total of all reporting groups
409239|NCT00597701|B2|Baseline|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
409240|NCT00597701|B1|Baseline|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
409241|NCT00597701|P2|Participant Flow|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
409242|NCT00597701|P1|Participant Flow|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
409243|NCT00597701|O2|Outcome|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
409244|NCT00597701|O1|Outcome|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
409245|NCT00597701|E2|Reported Event|Placebo|Standard benzodiazepine therapy plus placebo every eight hous as inpatients for 72 hours or until discharge if less than 72 hours.
409246|NCT00597701|E1|Reported Event|Baclofen|Standard benzodiazepine therapy plus baclofen 10 mg every 8 hours for 72 hours (9 doses) as an inpatient, or until discharge if before 72 hours.
409247|NCT00597584|B3|Baseline|Total|Total of all reporting groups
409248|NCT00597584|B2|Baseline|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409249|NCT00597584|B1|Baseline|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409250|NCT00597584|P2|Participant Flow|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409251|NCT00597584|P1|Participant Flow|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409275|NCT00596440|B3|Baseline|Total|Total of all reporting groups
409403|NCT00597272|B2|Baseline|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
416047|NCT00577135|O2|Outcome|Continuous Infusion|
409253|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409254|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409255|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409256|NCT00597584|O2|Outcome|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409257|NCT00597584|O1|Outcome|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409258|NCT00597584|E2|Reported Event|Epoetin|"Participants continued to receive commercially available epoetin alfa or beta by intravenous or subcutaneous injection, at the same starting dose, frequency and route of administration as received during the last week of the Screening Period, with the first study dose of epoetin alfa or beta administered after randomization at Week 0.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 g/dL and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409259|NCT00597584|E1|Reported Event|Peginesatide|"Participants received peginesatide by intravenous (IV) or subcutaneous (SC) injection once every 4 weeks. The starting dose was based on the participant's total weekly epoetin alfa or beta dose during the last week of the Screening Period; the first dose was administered one week after the last epoetin alfa or beta dose. Participants who received epoetin alfa or beta IV at the time of screening received peginesatide IV during the study, and participants who received epoetin alfa or beta SC at the time of screening received peginesatide SC during the study.~The dose was adjusted to maintain hemoglobin levels in a target range of 10.0-12.0 grams per deciliter (g/dL) and ± 1.5 g/dL from baseline during the Titration and Evaluation Periods, and 10.0-12.0 g/dL during the Long-Term Safety and Efficacy Period."
409260|NCT00596466|B1|Baseline|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409261|NCT00596466|P1|Participant Flow|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409262|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409263|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409264|NCT00596466|O1|Outcome|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409265|NCT00596466|E1|Reported Event|Pregabalin|Pregabalin capsules, 300 milligrams per day (mg/day) twice daily (BID) for 24 weeks. Dose adjustments of pregabalin permitted (range of 150-600 mg, BID) based on investigator judgment.
409266|NCT00596453|B3|Baseline|Total|Total of all reporting groups
409267|NCT00596453|B2|Baseline|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
409268|NCT00596453|B1|Baseline|Placebo|Placebo: Placebo twice a day for 14 days
409269|NCT00596453|P2|Participant Flow|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
409270|NCT00596453|P1|Participant Flow|Placebo|Placebo: Placebo twice a day for 14 days
409271|NCT00596453|O2|Outcome|Ciprofloxacin Hydrochloride|Ciprofloxacin hydrochloride: 250 mg Ciprofloxacin hydrochloride twice a day for 14 days
409272|NCT00596453|O1|Outcome|Placebo|Placebo: Placebo twice a day for 14 days
409367|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409276|NCT00596440|B2|Baseline|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409277|NCT00596440|B1|Baseline|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409278|NCT00596440|P2|Participant Flow|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409279|NCT00596440|P1|Participant Flow|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409280|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409281|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409282|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409283|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409284|NCT00596440|O2|Outcome|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409285|NCT00596440|O1|Outcome|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409286|NCT00596440|E2|Reported Event|Relatives of Orthopedic Patients|Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling
409287|NCT00596440|E1|Reported Event|Relatives of Cancer Patients|Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.
409288|NCT00596427|B3|Baseline|Total|Total of all reporting groups
409289|NCT00596427|B2|Baseline|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409290|NCT00596427|B1|Baseline|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409291|NCT00596427|P2|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409292|NCT00596427|P1|Participant Flow|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409293|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409294|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409295|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409296|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409297|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409298|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409299|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409300|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409301|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409302|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409303|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409304|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409305|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409306|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409307|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409368|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409369|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409308|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409309|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409310|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409311|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409312|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75grams/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409313|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409314|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409315|NCT00596427|O2|Outcome|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of colesevelam matched placebo for 12 weeks; three tablets with lunch and three tablets with dinner.
409316|NCT00596427|O1|Outcome|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409317|NCT00596427|E2|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Placebo|Subjects received six tablets a day of matched placebo(3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409318|NCT00596427|E1|Reported Event|Type-2 Diabetes Mellitus Patients Treated With Colesevelam|Subjects received six tablets a day of colesevelam (3.75g/day) for 12 weeks; three tablets with lunch and three tablets with dinner.
409319|NCT00597558|B1|Baseline|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
409320|NCT00597558|P1|Participant Flow|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
409321|NCT00597558|O1|Outcome|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
409322|NCT00597558|E1|Reported Event|Egg White Protein Powder|Egg allergic subjects who ingest oral egg white protein for desensitization and possible tolerance.
409323|NCT00597545|B3|Baseline|Total|Total of all reporting groups
409324|NCT00597545|B2|Baseline|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409325|NCT00597545|B1|Baseline|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409326|NCT00597545|P2|Participant Flow|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409327|NCT00597545|P1|Participant Flow|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409328|NCT00597545|O2|Outcome|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409329|NCT00597545|O1|Outcome|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409330|NCT00597545|E2|Reported Event|Prophylactic Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409331|NCT00597545|E1|Reported Event|Conventional Shunt|"Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by conventional management.~Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain~Shunt: A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain."
409332|NCT00597519|B1|Baseline|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
409333|NCT00597519|P1|Participant Flow|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
409334|NCT00597519|O1|Outcome|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
409335|NCT00597519|E1|Reported Event|Treatment|Cyclophosphamide, Fludarabine and Total Body Irradiation Followed by the Transplantation of Unrelated Donor Double Unit Umbilical Cord Blood Grafts for Patients with Hematological Malignancy
409336|NCT00597506|B1|Baseline|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
409337|NCT00597506|P1|Participant Flow|Drug: Bevacizumab and Everolimus|Open-label, non-randomized expanded cohort trial of refractory metastatic colorectal cancer subjects treated on 28 day cycles with the following treatment regimen: 10 mg/kg intravenous bevacizumab on days 1 and 15 each cycle and 10 mg everolimus(RAD001) daily by mouth.
409338|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
409339|NCT00597506|O1|Outcome|Bevacizumab and Everolimus|Enrolled participants on research study received bevacizumab at 10mg/kg every 2 weeks (day 1 and day 15 of each 28 day cycle) and everolimus at 10mg orally daily
409340|NCT00597506|E1|Reported Event|Bevacizumab and Everolimus|Expanded Cohort of Patients with Refractory Metastatic Colorectal Cancer Treated With Bevacizumab and Everolimus
409341|NCT00597493|B1|Baseline|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
409342|NCT00597493|P1|Participant Flow|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
409343|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
409344|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
409345|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
409346|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
409347|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
409348|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
409349|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
409350|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
409351|NCT00597493|O4|Outcome|Non-EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients not currently taking EIAEDs.
409352|NCT00597493|O3|Outcome|Non-EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients not currently taking EIAEDs.
409353|NCT00597493|O2|Outcome|EIAEDs-Day 28|Blood samples taken on day 28 of cycle 1 from patients currently taking EIAEDs.
409354|NCT00597493|O1|Outcome|EIAEDs-Day 1|Blood samples taken on day 1 of cycle 1 from patients currently taking EIAEDs.
409355|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
409356|NCT00597493|O1|Outcome|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
409357|NCT00597493|E1|Reported Event|Sorafenib + Temozolomide|"Subjects receive 400mg of Sorafenib twice daily and 50mg/m^2 of Temozolomide once daily~Subjects continue to receive treatment until any of the following: progressive disease, unacceptable toxicity, non-compliance with study guidelines, withdrawal of patient consent, intercurrent non-cancer-related illness that prevents continuation of therapy or regular follow-up, general or specific changs in a subject's condition which render the patient unacceptable for treatment in the judgement of the investigator, or study closure"
409358|NCT00597428|B3|Baseline|Total|Total of all reporting groups
409359|NCT00597428|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409360|NCT00597428|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409361|NCT00597428|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for 12 weeks
409362|NCT00597428|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for 12 weeks
409363|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409364|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409365|NCT00597428|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409366|NCT00597428|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409377|NCT00597402|B1|Baseline|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409378|NCT00597402|P1|Participant Flow|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409379|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409380|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409381|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409382|NCT00597402|O1|Outcome|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409383|NCT00597402|E1|Reported Event|Avastin, Radiation, Temozolomide, and Irinotecan|"Treatment with standard XRT (radiation) and daily temozolomide 75 mg/m2/day for 6.5 weeks of XRT. Avastin will be administered 10 mg/kg every other week beginning a minimum of 28 days after last major surgical procedure, open biopsy, or significant traumatic injury.~Following completion of XRT, patients will receive 6 cycles of Avastin, temozolomide, and irinotecan. Beginning a minimum of 14 days after last XRT, Avastin at 10 mg/kg with irinotecan every other week; temozolomide will be given at 200 mg/m2/day on the 1st 5 days of each 28-day cycle. The irinotecan dose will depend on whether the patient is taking enzyme-inducing antiepileptic drugs (EIAED). (EIAED:340 mg/m2 every other week, non-EIAED:125 mg/m2.)"
409384|NCT00597376|B3|Baseline|Total|Total of all reporting groups
409385|NCT00597376|B2|Baseline|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
409386|NCT00597376|B1|Baseline|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
409387|NCT00597376|P2|Participant Flow|Cerefolin NAC Placebo + Multivitamin|"On placebo and open label multivitamin supplement~Cerefolin NAC placebo : Placebo tablet once a day"
409388|NCT00597376|P1|Participant Flow|Cerefolin NAC + Multivitamin|"On Cerefolin NAC and open-label multivitamin supplement~Cerefolin NAC (a medical food) : Cerefolin NAC one tablet each day"
409389|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
409390|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
409391|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
409392|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
409393|NCT00597376|O2|Outcome|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
409394|NCT00597376|O1|Outcome|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
409395|NCT00597376|E2|Reported Event|Cerefolin NAC Placebo + Multivitamin|On placebo and open-label multivitamin supplement
409396|NCT00597376|E1|Reported Event|Cerefolin NAC + Multivitamin|On Cerefolin NAC and open-label multivitamin supplement
409397|NCT00597272|B8|Baseline|Total|Total of all reporting groups
409404|NCT00597272|B1|Baseline|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409405|NCT00597272|P7|Participant Flow|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
409406|NCT00597272|P6|Participant Flow|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409407|NCT00597272|P5|Participant Flow|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409408|NCT00597272|P4|Participant Flow|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
409409|NCT00597272|P3|Participant Flow|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409410|NCT00597272|P2|Participant Flow|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409411|NCT00597272|P1|Participant Flow|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409412|NCT00597272|O7|Outcome|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
409413|NCT00597272|O6|Outcome|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409414|NCT00597272|O5|Outcome|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409415|NCT00597272|O4|Outcome|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
409416|NCT00597272|O3|Outcome|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409417|NCT00597272|O2|Outcome|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409418|NCT00597272|O1|Outcome|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409419|NCT00597272|E7|Reported Event|Cohort 3|Cohort 3: 150mcg OPT-821 for first 5 vaccines with a 50 mcg increase in dose for the final vaccine.
409420|NCT00597272|E6|Reported Event|Cohort 2C|Cohort 2C: 100mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409421|NCT00597272|E5|Reported Event|Cohort 2B|Cohort 2B: 75mcg QS-DG weeks 1, 2, 3, 8, 20 ,32
409422|NCT00597272|E4|Reported Event|Cohort 2A|Cohort 2A: 50mcg QS-DG weeks 1, 2, 3, 8, 20, 32
409423|NCT00597272|E3|Reported Event|Cohort 1C|Cohort 1C: 100mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409424|NCT00597272|E2|Reported Event|Cohort 1B|Cohort 1B: 75mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409425|NCT00597272|E1|Reported Event|Cohort 1A|Cohort 1A: 50mcg OPT-821 weeks 1, 2, 3, 8, 20, 32
409426|NCT00597207|B3|Baseline|Total|Total of all reporting groups
409427|NCT00597207|B2|Baseline|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
409428|NCT00597207|B1|Baseline|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
409429|NCT00597207|P2|Participant Flow|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
409430|NCT00597207|P1|Participant Flow|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
409431|NCT00597207|O2|Outcome|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
409432|NCT00597207|O1|Outcome|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
409433|NCT00597207|E2|Reported Event|M-CPR|"Manual CPR All subjects initially receive manual chest compressions. After randomization, subjects randomized to M-CPR continue to receive manual chest compressions.~Manual: Manual chest compression"
409434|NCT00597207|E1|Reported Event|iA-CPR|"Integrated Mechanical CPR with AutoPulse All subjects initially receive manual chest compressions. After randomization, subjects randomized to iA-CPR are moved to the device once it is ready and from thereon receive mechanical chest compressions.~AutoPulse: Mechanical device that provides chest compression"
409435|NCT00597116|B3|Baseline|Total|Total of all reporting groups
409436|NCT00597116|B2|Baseline|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409437|NCT00597116|B1|Baseline|Vandetanib|Vandetanib 300 mg/day oral
409438|NCT00597116|P2|Participant Flow|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409439|NCT00597116|P1|Participant Flow|Vandetanib|Vandetanib 300 mg/day oral
409440|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409441|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
409442|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409443|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
409444|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409445|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
409446|NCT00597116|O2|Outcome|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409447|NCT00597116|O1|Outcome|Vandetanib|Vandetanib 300 mg/day oral
409448|NCT00597116|E2|Reported Event|Vinorelbine|Vinorelbine 30 mg/m2 iv, administrated weekly
409449|NCT00597116|E1|Reported Event|Vandetanib|Vandetanib 300 mg/day oral
409450|NCT00597038|B3|Baseline|Total|Total of all reporting groups
409451|NCT00597038|B2|Baseline|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
409452|NCT00597038|B1|Baseline|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
409453|NCT00597038|P2|Participant Flow|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
409588|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409454|NCT00597038|P1|Participant Flow|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
409455|NCT00597038|O2|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
409456|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
409457|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
409458|NCT00597038|O1|Outcome|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC)
409459|NCT00597038|O1|Outcome|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC)
409460|NCT00597038|E2|Reported Event|Phase II Dose Treatment|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The recommended phase II dose was dasatinib 70 mg BID with dacarbazine 800 mgm^2.
409461|NCT00597038|E1|Reported Event|Phase I Dose Escalation|Dasatinib and Dacarbazine (DTIC). Dasatinib and Dacarbazine (DTIC). The first cohort was a dasatinib dose of 50 mg by mouth (PO) twice a day (BID) given days 2-19 with DTIC given at a dose of 800 mg/m2 once every 3 weeks. The dose escalation was continued until MTD and a recommended Phase II dose was established.
409462|NCT00597012|B3|Baseline|Total|Total of all reporting groups
409463|NCT00597012|B2|Baseline|Physical Therapy|Participants will undergo standard physical therapy that will include strengthening and stretching sessions one to three times a week for 8 weeks.
409464|NCT00597012|B1|Baseline|Arthroscopic Partial Meniscectomy|Participants will undergo arthroscopic partial menisectomy (APM) surgery and offered postoperative rehabilitative physical therapy.
409465|NCT00597012|P2|Participant Flow|Physical Therapy (PT)|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
409466|NCT00597012|P1|Participant Flow|Arthroscopic Partial Meniscectomy (APM)|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
409467|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
409468|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
409469|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
409470|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
409471|NCT00597012|O2|Outcome|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
409472|NCT00597012|O1|Outcome|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were referred for postoperative rehabilitative physical therapy.
409473|NCT00597012|E2|Reported Event|Physical Therapy|Participants underwent standard physical therapy that included strengthening and stretching sessions one to three times a week for 8 weeks.
409474|NCT00597012|E1|Reported Event|Arthroscopic Partial Meniscectomy|Participants underwent arthroscopic partial menisectomy (APM) surgery and were offered postoperative rehabilitative physical therapy.
409475|NCT00596960|B3|Baseline|Total|Total of all reporting groups
409476|NCT00596960|B2|Baseline|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409477|NCT00596960|B1|Baseline|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409478|NCT00596960|P2|Participant Flow|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409479|NCT00596960|P1|Participant Flow|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409480|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409481|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409482|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409483|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409484|NCT00596960|O2|Outcome|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409485|NCT00596960|O1|Outcome|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409589|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409590|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409591|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409486|NCT00596960|E2|Reported Event|Arm 2|"health education intervention~Health education: Health education intervention will serve as the active control. The intervention will consist of 4 sessions of health education with a focus on sleep hygiene, nutrition, exercise and relaxation training."
409487|NCT00596960|E1|Reported Event|Arm 1|"Motivational enhancement therapy~Motivational Enhancement Therapy (MET): MET is a 4 session intervention based on motivational approaches that was successful in project MATCH."
409488|NCT00596947|B3|Baseline|Total|Total of all reporting groups
409489|NCT00596947|B2|Baseline|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409490|NCT00596947|B1|Baseline|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409491|NCT00596947|P2|Participant Flow|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409492|NCT00596947|P1|Participant Flow|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409493|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409494|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409495|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409496|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409497|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409498|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409499|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409500|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409501|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409592|NCT00596817|E3|Reported Event|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|
409593|NCT00596817|E2|Reported Event|Placebo - Double-blind Period (FAS)|
409594|NCT00596817|E1|Reported Event|Open-label Period (APTS)|
409502|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409503|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409504|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409505|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409506|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409507|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409508|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409509|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409510|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409511|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409512|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409513|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409514|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409515|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409554|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409516|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409517|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409518|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409519|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409520|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409521|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409522|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409523|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409524|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409525|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409526|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409527|NCT00596947|O2|Outcome|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409528|NCT00596947|O1|Outcome|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409529|NCT00596947|E2|Reported Event|Prednisone Maintenance|Participants randomized to the prednisone maintenance arm were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf(tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids, initially as Solu-medrol(methylprednisolone) given through the vein in the arm and then as daily oral prednisone tablets. Participants in this arm received all drugs according to their doctors' standard of care and the prednisone was not be eliminated.
409583|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409584|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409585|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409586|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409530|NCT00596947|E1|Reported Event|Prednisone Withdrawal|Participants randomized to the prednisone withdrawal group , were started on 4 drugs; Thymoglobulin (Rabbit antithymocyte globulin) Prograf (tacrolimus), CellCept (mycophenolate mofetil) and corticosteroids initially given as Solu-medrol (methylprednisolone) through a vein in the arm, and then given orally daily as prednisone tablets. The dose of prednisone for participants in this group was rapidly decreased until it was completely eliminated by day 6 after transplant.
409531|NCT00596934|B1|Baseline|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409532|NCT00596934|P1|Participant Flow|NASH02|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409533|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409534|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409535|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409536|NCT00596934|O1|Outcome|Metreleptin Treatment Group|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
409537|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409538|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409539|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin: 0.1 mg/kg/day once a day via subcutaneous injections"
409540|NCT00596934|O1|Outcome|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409541|NCT00596934|E1|Reported Event|Metreleptin Treatment Arm|"Treatment group~metreleptin : 0.1 mg/kg/day once a day via subcutaneous injections"
409542|NCT00596830|B3|Baseline|Total|Total of all reporting groups
409543|NCT00596830|B2|Baseline|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409544|NCT00596830|B1|Baseline|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409545|NCT00596830|P2|Participant Flow|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409546|NCT00596830|P1|Participant Flow|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409547|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409548|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409549|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409550|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409551|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409552|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409553|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409587|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409595|NCT00596752|B3|Baseline|Total|Total of all reporting groups
409555|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409556|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409557|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409558|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409559|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409560|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409561|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409562|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409563|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409564|NCT00596830|O2|Outcome|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409565|NCT00596830|O1|Outcome|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409566|NCT00596830|E2|Reported Event|Paclitaxel and Carboplatin (Chemo)|Standard platinum-based doublet chemotherapy (chemo) consisting of paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) was administered via IV on Day 1 of a 3-week cycle. Chemo treatment continued for a maximum of 6 cycles.
409567|NCT00596830|E1|Reported Event|Figitumumab + Paclitaxel and Carboplatin|Figitumumab (figi, [CP-751, 871]) was given in combination with paclitaxel (200 milligram/square metre [mg/m^2]) and carboplatin (area under the concentration-time curve [AUC]=6) administered in 3-week cycles. Figi 20 milligram/kilogram (mg/kg) was administered intravenously (IV) on Day 1 of a 3-week cycle for up to 6 cycles, followed by single agent figi maintenance in every 3-week cycles after completion or discontinuation of chemotherapy for reasons other than disease progression.
409568|NCT00596817|B4|Baseline|Total|Total of all reporting groups
409569|NCT00596817|B3|Baseline|Vortioxetine: 5 or 10 mg - Double-blind Period (FAS)|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
409570|NCT00596817|B2|Baseline|Placebo - Double-blind Period (FAS)|Placebo : capsules, daily, orally
409571|NCT00596817|B1|Baseline|Open-label Period (APTS)|
409572|NCT00596817|P2|Participant Flow|Vortioxetine: 5 or 10 mg|Vortioxetine (Lu AA21004) : encapsulated tablets, daily, orally
409573|NCT00596817|P1|Participant Flow|Placebo|Placebo : capsules, daily, orally
409574|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409575|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409576|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409577|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409578|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409579|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409580|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409581|NCT00596817|O1|Outcome|Placebo|capsules, daily, orally
409582|NCT00596817|O2|Outcome|Vortioxetine: 5 or 10 mg|encapsulated tablets, daily, orally
409596|NCT00596752|B2|Baseline|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409597|NCT00596752|B1|Baseline|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409598|NCT00596752|P2|Participant Flow|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409599|NCT00596752|P1|Participant Flow|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409600|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409601|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409602|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409603|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409604|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409605|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409606|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409607|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409608|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409609|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409610|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409611|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409612|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409613|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409614|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409615|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409616|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409617|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409618|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409619|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409620|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409621|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409622|NCT00596752|O2|Outcome|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409623|NCT00596752|O1|Outcome|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409624|NCT00596752|E2|Reported Event|Placebo|"Placebo will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Placebo: - Active Substance: Lactose~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409625|NCT00596752|E1|Reported Event|Alprostadil|"Prostavasin® 40 μg will be infused intravenously twice daily over 2 hours in 50 to 150 ml isotonic sodium chloride solution during a Treatment Phase of 4 weeks.~Alprostadil: - Active Substance: Prostaglandin E1~Pharmaceutical Form: solution for infusion~Concentration: 40 μg b.d.~Route of Administration: intravenous infusion"
409626|NCT00596687|B3|Baseline|Total|Total of all reporting groups
409627|NCT00596687|B2|Baseline|SSRI|Sliding scale regular insulin four-times daily.
409628|NCT00596687|B1|Baseline|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
409629|NCT00596687|P2|Participant Flow|SSRI|Sliding scale regular insulin four-times daily if blood glucose > 140 before meals and at bedtime. The sliding scale regimen was per the hospital protocol.
409630|NCT00596687|P1|Participant Flow|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine. A total of 0.5 units of insulin/day given, half as basal glargine insulin once a day and the other half as mealtime glulisine given three times a day at meals.
409631|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
409632|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
409633|NCT00596687|O2|Outcome|SSRI|Sliding scale regular insulin four-times daily.
409634|NCT00596687|O1|Outcome|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
409635|NCT00596687|E2|Reported Event|SSRI|Sliding scale regular insulin four-times daily.
409636|NCT00596687|E1|Reported Event|Basal Bolus|Glargine and rapid-acting mealtime insulin plus supplemental glulisine
409637|NCT00596635|B4|Baseline|Total|Total of all reporting groups
409638|NCT00596635|B3|Baseline|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409639|NCT00596635|B2|Baseline|One Cranberry Capsule|1 650mg cranberry capsule daily
409640|NCT00596635|B1|Baseline|No Cranberry Capsules|Control Group No Cranberry Capsule
409641|NCT00596635|P3|Participant Flow|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409642|NCT00596635|P2|Participant Flow|One Cranberry Capsule|1 650mg cranberry capsule daily
409643|NCT00596635|P1|Participant Flow|No Cranberry Capsules|Control Group No Cranberry Capsule
409644|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409645|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
409646|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
409647|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409648|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
409649|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
409650|NCT00596635|O3|Outcome|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409651|NCT00596635|O2|Outcome|One Cranberry Capsule|1 650mg cranberry capsule daily
409652|NCT00596635|O1|Outcome|No Cranberry Capsules|Control Group No Cranberry Capsule
409653|NCT00596635|E3|Reported Event|2 Cranberry Capsules|1 650 mg cranberry capsule twice daily (bid)
409654|NCT00596635|E2|Reported Event|One Cranberry Capsule|1 650mg cranberry capsule daily
409655|NCT00596635|E1|Reported Event|No Cranberry Capsules|Control Group No Cranberry Capsule
409656|NCT00596622|B4|Baseline|Total|Total of all reporting groups
409657|NCT00596622|B3|Baseline|Bipolar Euthymic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
409676|NCT00596271|P3|Participant Flow|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
409658|NCT00596622|B2|Baseline|Bipolar Manic Subjects Treated With Lithium|"Participants with bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
409659|NCT00596622|B1|Baseline|Bipolar Depressed Subjects Treated With Lithium|"Participants with bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Depression and mania scores before and after treatment"
409660|NCT00596622|P1|Participant Flow|Bipolar Subjects Who Were Included in Lithium Treatment Arm|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
409661|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Bipolar euthymia picture response before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
409662|NCT00596622|O2|Outcome|Bipolar Depressed Subjects Treated|"Bipolar depression picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
409663|NCT00596622|O1|Outcome|Bipolar Manic Subjects Treated|"Bipolar mania picture response during fMRI before and after treatment with lithium~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment."
409664|NCT00596622|O3|Outcome|Bipolar Euthymic Subjects Treated|"Participants with bipolar euthymia who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
409665|NCT00596622|O2|Outcome|Bipolar Manic Subjects Treated|"Participants with bipolar mania who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks"
409666|NCT00596622|O1|Outcome|Bipolar Depressed Participants Treated|"Participants with bipolar depression who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks."
409667|NCT00596622|E1|Reported Event|Bipolar Participants Treated|"Participants with bipolar disorder who undergo fMRI and lithium treatment~Lithium: Dosing will start as one 300-mg capsule per day and will be titrated up to four 300-mg capsules per day for a total of 8 weeks of treatment.~Picture response during fMRI: While undergoing an fMRI scan, participants will be presented with pictures, letters, words, and sounds to evoke emotional responses. There will be a maximum of three MRI scans over 9 weeks.~Adverse Events information was collected irrespective of the sub-grouping"
409668|NCT00596362|B1|Baseline|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
409669|NCT00596362|P1|Participant Flow|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
409670|NCT00596362|O1|Outcome|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
409671|NCT00596362|E1|Reported Event|AVASTIN|AVASTIN: a single injection of Avastin at the outpatient clinic. This will be done as follows: the pupil in the eye being treated will be enlarged with a liquid solution. Thirty minutes later, a numbing solution and then a cleansing solution will be put in to the eye. Finally, an injection of Avastin will be given into the eye. Right after this injection, your eye will be examined by your doctor. The pressure in your eye will also be tested before and after the injection. Patients will use antibiotic drops for 5 days following the injection. Following the injection, you will have weekly examinations for four weeks in the office.
409672|NCT00596271|B4|Baseline|Total|Total of all reporting groups
409673|NCT00596271|B3|Baseline|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
409674|NCT00596271|B2|Baseline|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
409675|NCT00596271|B1|Baseline|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
409677|NCT00596271|P2|Participant Flow|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
409678|NCT00596271|P1|Participant Flow|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
409679|NCT00596271|O2|Outcome|IC51 + HAVRIX|
409680|NCT00596271|O1|Outcome|HAVRIX + Placebo|
409681|NCT00596271|O2|Outcome|IC51 and HAVRIX|
409682|NCT00596271|O1|Outcome|IC51 and Placebo|
409683|NCT00596271|E3|Reported Event|IC51 and HAVRIX|IC51 6 mcg i.m. with 2 injections (day 0 and 28) and HAVRIX with 1 injection (day 0)
409684|NCT00596271|E2|Reported Event|HAVRIX and Placebo|HAVRIX with 1 injection (day 0) and placebo 0.5 mL with 2 injections (day 0 and 28)
409685|NCT00596271|E1|Reported Event|IC51 and Placebo|6 mcg i.m. IC51 with 2 injections (day 0 and 28)and placebo 0.5 mL with 1 injection (day 0)
409686|NCT00596167|B1|Baseline|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
409687|NCT00596167|P1|Participant Flow|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
409688|NCT00596167|O1|Outcome|Intravenous Antibiotic (Vancomycin)|This study will have only one arm. All six participants in the study will receive an intravenous dose of the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
409689|NCT00596167|E1|Reported Event|Intravenous Antibiotics|This study will have only one arm. This will be the experimental arm receiving the intravenous antibiotics, levofloxacin, vancomycin and gentamicin.
409690|NCT00596102|B4|Baseline|Total|Total of all reporting groups
409691|NCT00596102|B3|Baseline|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
409692|NCT00596102|B2|Baseline|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
409693|NCT00596102|B1|Baseline|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
409694|NCT00596102|P3|Participant Flow|Placebo|no treatment in study IC51-303, vaccinations were performed in preceeding study IC51-302
409695|NCT00596102|P2|Participant Flow|JE-VAX|no active treatment in study IC51-303, vaccinations were performed in preceeding study IC51-301
409696|NCT00596102|P1|Participant Flow|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
409697|NCT00596102|O1|Outcome|IC51|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302
409698|NCT00596102|E4|Reported Event|IC51 Month 60|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 60
409699|NCT00596102|E3|Reported Event|Placebo|no active treatment in study IC51-303, Plarcebo vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
409700|NCT00596102|E2|Reported Event|JE-VAX|no active treatment in study IC51-303, JE-VAX vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
409701|NCT00596102|E1|Reported Event|IC51 Month 6|no active treatment in study IC51-303, IC51 vaccinations were performed in preceeding study IC51-301 or IC51-302; follow-up till Month 6
409702|NCT00596011|B3|Baseline|Total|Total of all reporting groups
409703|NCT00596011|B2|Baseline|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409704|NCT00596011|B1|Baseline|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409705|NCT00596011|P2|Participant Flow|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409706|NCT00596011|P1|Participant Flow|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409707|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409708|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409709|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409710|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409711|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409712|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409713|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409714|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409715|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409716|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409717|NCT00596011|O2|Outcome|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409718|NCT00596011|O1|Outcome|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409719|NCT00596011|E2|Reported Event|Placebo Comparator: Placebo Administration|Matching placebo twice a day (BID)
409720|NCT00596011|E1|Reported Event|Active Comparator: Polyphenon E Treatment|Polyphenon E, 200 mg epigallocatechin gallate (EGCG) twice a day (BID)
409721|NCT00595959|B1|Baseline|Laser Treatment|CLiRpath Photoablation Atherectomy System
409722|NCT00595959|P1|Participant Flow|Laser Treatment|CLiRpath Photoablation Atherectomy System
409723|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409724|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409725|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409726|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409727|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409728|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409729|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409730|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409731|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409732|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409733|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409734|NCT00595959|O1|Outcome|Laser Treatment|CLiRpath Photoablation Atherectomy System
409735|NCT00595959|E1|Reported Event|Laser Treatment|CLiRpath Photoablation Atherectomy System
409736|NCT00595946|B3|Baseline|Total|Total of all reporting groups
409737|NCT00595946|B2|Baseline|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409738|NCT00595946|B1|Baseline|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409739|NCT00595946|P2|Participant Flow|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID) for up to 12 weeks
409740|NCT00595946|P1|Participant Flow|Placebo|Placebo : 0 mcg capsules twice daily (BID) for up to 12 weeks
409741|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409742|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409743|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409744|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409745|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409746|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409747|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409748|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409749|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409750|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409751|NCT00595946|O2|Outcome|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409752|NCT00595946|O1|Outcome|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409753|NCT00595946|E2|Reported Event|Lubiprostone|Lubiprostone : 24 mcg capsules twice daily (BID)
409754|NCT00595946|E1|Reported Event|Placebo|Placebo : 0 mcg capsules twice daily (BID)
409755|NCT00595920|B1|Baseline|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
409756|NCT00595920|P1|Participant Flow|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
409757|NCT00595920|O1|Outcome|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
409758|NCT00595920|E1|Reported Event|Open Label Extension|"30-45 million autologous myelin reactive T cells~Tovaxin: 2 mL subcutaneous injections administered by a healthcare provider at weeks 0, 4, 8, 12, and 24 every year as required."
409759|NCT00595881|B1|Baseline|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
409760|NCT00595881|P1|Participant Flow|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
409761|NCT00595881|O2|Outcome|Clinical Exam+ Ultrasound|Patients will have data collected following the addition of a bedside ultrasound performed to the clinical exam.
409762|NCT00595881|O1|Outcome|Clinical Exam Alone|Patients will have data collected from their clinical examination alone
409763|NCT00595881|E1|Reported Event|Ultrasound|One group of patients will undergo emergency bedside ultrasound in addition to the clinical examination.
409764|NCT00595868|B3|Baseline|Total|Total of all reporting groups
409765|NCT00595868|B2|Baseline|Placebo|Placebo once per day for 2-8 weeks
409766|NCT00595868|B1|Baseline|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
409767|NCT00595868|P2|Participant Flow|Placebo|Placebo once per day for 2-8 weeks
409768|NCT00595868|P1|Participant Flow|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
409769|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
409770|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
409771|NCT00595868|O2|Outcome|Placebo|Placebo once per day for 2-8 weeks
409772|NCT00595868|O1|Outcome|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
409773|NCT00595868|E2|Reported Event|Placebo|Placebo once per day for 2-8 weeks
409774|NCT00595868|E1|Reported Event|Varenicline|2 milligrams varenicline once per day for 2-8 weeks
409775|NCT00595790|B4|Baseline|Total|Total of all reporting groups
409776|NCT00595790|B3|Baseline|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
409777|NCT00595790|B2|Baseline|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
409778|NCT00595790|B1|Baseline|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
409779|NCT00595790|P3|Participant Flow|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
409780|NCT00595790|P2|Participant Flow|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
409781|NCT00595790|P1|Participant Flow|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
409782|NCT00595790|O3|Outcome|IC51 1x6 mcg|
409783|NCT00595790|O2|Outcome|IC51 2x6 mcg|
409784|NCT00595790|O1|Outcome|IC51 1 x 12 mcg|
409785|NCT00595790|E3|Reported Event|IC51 1 x 6 mcg|1 x 6 mcg (microgram)
409786|NCT00595790|E2|Reported Event|IC51 1 x 12 mcg|1 x 12 mcg (microgram)
409787|NCT00595790|E1|Reported Event|IC51 2 x 6 mcg|2 x 6 mcg (microgram)
409788|NCT00595764|B3|Baseline|Total|Total of all reporting groups
409812|NCT00595556|P2|Participant Flow|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409981|NCT00595075|P2|Participant Flow|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
409789|NCT00595764|B2|Baseline|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409790|NCT00595764|B1|Baseline|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409791|NCT00595764|P2|Participant Flow|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409792|NCT00595764|P1|Participant Flow|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409793|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409794|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409795|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409796|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409797|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409813|NCT00595556|P1|Participant Flow|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409814|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409798|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409799|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409800|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409801|NCT00595764|O2|Outcome|Physician Management Plus Cognitive Behavioral Therapy|In addition to receiving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409802|NCT00595764|O1|Outcome|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient's recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409803|NCT00595764|E2|Reported Event|Physician Management Plus Cognitive Behavioral Therapy|In addition to recieving Physician Management identical to the Physician Management only condition, patients were offered up to 12, 50-minute weekly sessions during the first 12 weeks of treatment. Cognitive behavioral therapy was provided by masters- and doctoral-level clinicians who were trained to competence using a manual adapted from the use of cognitive behavioral therapy for cocaine dependence. To ensure fidelity, all sessions were audio- or video-taped, and clinicians underwent weekly supervision. The main components of counseling focused on a functional analysis of behavior, behavioral activation, identifying and coping with drug cravings, enhancing drug-refusal skills, enhancing decision making about high-risk situations and improve problem-solving skills.
409804|NCT00595764|E1|Reported Event|Physician Management|Physician management was provided during fifteen to twenty minute sessions by Internal Medicine physicians with experience providing buprenorphine. Sessions occurred weekly for the first two weeks, every two weeks for the next four weeks, then monthly. During physician management the physician followed a structured note that reviewed the patient’s recent drug use, provided brief advice on how to achieve or maintain abstinence, supported efforts to reduce drug use or remain abstinent, reviewed medical and psychiatric complaints, assessed social, work and legal function, discussed weekly urine toxicology results and reviewed attendance at self-help groups.
409805|NCT00595582|B1|Baseline|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
409806|NCT00595582|P1|Participant Flow|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
409807|NCT00595582|O1|Outcome|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
409808|NCT00595582|E1|Reported Event|Curcumin + Bioperine|Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
409809|NCT00595556|B3|Baseline|Total|Total of all reporting groups
409810|NCT00595556|B2|Baseline|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409811|NCT00595556|B1|Baseline|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409841|NCT00595504|P1|Participant Flow|Ramelteon|
410327|NCT00594399|B2|Baseline|Arm 2|Usual care from primary, womens or geriatric clinics
409815|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409816|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409817|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409818|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409819|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409820|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409821|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409822|NCT00595556|O2|Outcome|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409823|NCT00595556|O1|Outcome|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409824|NCT00595556|E2|Reported Event|Placebo|"Subjects in this arm received a double blind placebo lactose capsule identical to the over-capsule on the actual medicine. The titration of dose and number of pills matched that of the zonisamide arm."
409825|NCT00595556|E1|Reported Event|Zonisamide Medication Treatment|Subjects in this arm received the zonisamide anticonvulsant medication in double blind fashion starting with 100mg daily and titrated every other week to a target dose of 500mg daily. The pills were over-encapsulated to match the placebo.
409826|NCT00595530|B1|Baseline|Protocol for Administering Ketamine to Patients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
409827|NCT00595530|P1|Participant Flow|Procedure for Administering Ketamine to SCDpatients|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
409828|NCT00595530|O1|Outcome|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
409829|NCT00595530|E1|Reported Event|Ketamine|"This group will receive ketamine~ketamine: The medication will be administered intravenously. This study will utilize 4 doses of ketamine: 0.05 mg/kg/hour, 0.1 mg/kg/hour, 0.15 mg/kg/hour, and 0.2 mg/kg/hour.~Dosing Regimen:~All patients will begin the ketamine infusion at 0.05 mg/kg/hour.~4 or more hours after the infusion is started, the dose may be increased to 0.1 mg/kg/hour if:~the patient's pain has not improved to an acceptable level (pain score is still ≥5)~side effects remain acceptable~4 hours or more after the previous increase, the dose may be adjusted to 0.15 mg/kg/hour~4 hours or more after the previous increase, the dose may be adjusted to 0.2 mg/kg/hour~The maximum dose of ketamine will be limited to 300 mg per 24 hours~The patient may receive ketamine up to 72 hours after initiation."
409830|NCT00595517|B1|Baseline|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409831|NCT00595517|P1|Participant Flow|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409832|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409833|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409834|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409835|NCT00595517|O1|Outcome|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409836|NCT00595517|E1|Reported Event|Esomeprazole 20mg|Esomeprazole 20 mg once daily oral
409837|NCT00595504|B3|Baseline|Total|Total of all reporting groups
409838|NCT00595504|B2|Baseline|Placebo|sugar pill
409839|NCT00595504|B1|Baseline|Ramelteon|
409840|NCT00595504|P2|Participant Flow|Placebo|sugar pill
409842|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409843|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409844|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409845|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409846|NCT00595504|O2|Outcome|Placebo (Sugar Pill)|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409847|NCT00595504|O1|Outcome|Ramelteon|A double-blind, placebo-controlled, 8-week pilot trial was conducted, adding ramelteon 8 mg/day to stable outpatients with schizophrenia.
409848|NCT00595504|E2|Reported Event|Placebo|sugar pill
409849|NCT00595504|E1|Reported Event|Ramelteon|
409850|NCT00595465|B4|Baseline|Total|Total of all reporting groups
409851|NCT00595465|B3|Baseline|IC51 Batch IC51/07E/008A|
409852|NCT00595465|B2|Baseline|IC51 Batch IC51/07E/007A|
409853|NCT00595465|B1|Baseline|IC51 Batch IC51/07E/006A|
409854|NCT00595465|P3|Participant Flow|IC51 Batch IC51/07E/008A|
409855|NCT00595465|P2|Participant Flow|IC51 Batch IC51/07E/007A|
409856|NCT00595465|P1|Participant Flow|IC51 Batch IC51/07E/006A|
409857|NCT00595465|O3|Outcome|IC51 Batch IC51/07E/008A|
409858|NCT00595465|O2|Outcome|IC51 Batch IC51/07E/007A|
409859|NCT00595465|O1|Outcome|IC51 Batch IC51/07E/006A|
409860|NCT00595465|E3|Reported Event|IC51 Batch IC51/07E/008A|
409861|NCT00595465|E2|Reported Event|IC51 Batch IC51/07E/007A|
409862|NCT00595465|E1|Reported Event|IC51 Batch IC51/07E/006A|
409863|NCT00595413|B5|Baseline|Total|Total of all reporting groups
409864|NCT00595413|B4|Baseline|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409865|NCT00595413|B3|Baseline|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409866|NCT00595413|B2|Baseline|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409867|NCT00595413|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409868|NCT00595413|P4|Participant Flow|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409869|NCT00595413|P3|Participant Flow|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409870|NCT00595413|P2|Participant Flow|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409871|NCT00595413|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409872|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409873|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409874|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409875|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409876|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409877|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409878|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409879|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409880|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409881|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409882|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409883|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409884|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409885|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409886|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409887|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409888|NCT00595413|O4|Outcome|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409889|NCT00595413|O3|Outcome|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409890|NCT00595413|O2|Outcome|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409891|NCT00595413|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409892|NCT00595413|E4|Reported Event|Adalimumab|Adalimumab (Humira®) was administered subcutaneously at a dose of 40 mg every other week for 25 weeks.
409893|NCT00595413|E3|Reported Event|Atacicept 150 mg Without Loading Dose|Atacicept was administered subcutaneously at a dose of 150 mg once a week for 25 weeks. Participants also received placebo matched to atacicept subcutaneously once a week during initial 4 weeks for blinding purpose (placebo injections alternating with atacicept injections).
409894|NCT00595413|E2|Reported Event|Atacicept 150 mg With Loading Dose|Atacicept was administered subcutaneously at a dose of 150 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
409895|NCT00595413|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
409896|NCT00595361|B3|Baseline|Total|Total of all reporting groups
409897|NCT00595361|B2|Baseline|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409898|NCT00595361|B1|Baseline|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409899|NCT00595361|P2|Participant Flow|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409900|NCT00595361|P1|Participant Flow|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409901|NCT00595361|O2|Outcome|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409902|NCT00595361|O1|Outcome|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409903|NCT00595361|E2|Reported Event|Gly/Gly|"Gly/Gly subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409904|NCT00595361|E1|Reported Event|Arg/Arg|"Arg/Arg subjects on 2 week salmeterol treatment~salmeterol: salmeterol 50 micrograms twice daily for 2 weeks"
409905|NCT00595335|B3|Baseline|Total|Total of all reporting groups
409906|NCT00595335|B2|Baseline|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409907|NCT00595335|B1|Baseline|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409908|NCT00595335|P2|Participant Flow|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409909|NCT00595335|P1|Participant Flow|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409910|NCT00595335|O2|Outcome|Placebo|Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
409911|NCT00595335|O1|Outcome|Rituximab|Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.
409912|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409913|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409914|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409915|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409916|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409917|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409918|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409919|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409920|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409921|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409922|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409923|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409924|NCT00595335|O2|Outcome|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409925|NCT00595335|O1|Outcome|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409926|NCT00595335|E2|Reported Event|Placebo|"Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Saline: Subjects will receive 2 infusions of saline IV, 2 weeks apart, each preceded by a premedication saline IV."
409927|NCT00595335|E1|Reported Event|Rituximab|"Rituximab 1000 mg IV twice at 2-week intervals, each preceded by Methylprednisolone 100 mg IV as premedication to the rituximab infusion. All subjects will be treated with an acetaminophen tablet and a diphenhydramine hydrochloride tablet before the infusion.~Rituximab: Subjects will receive 2 infusions of rituximab (1000 mg IV), two weeks apart.~Methylprednisolone: Subjects will receive methylprednisolone 100 mg IV as premedication to the rituximab infusion."
409928|NCT00595309|B1|Baseline|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
409929|NCT00595309|P1|Participant Flow|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
409930|NCT00595309|O1|Outcome|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
409931|NCT00595309|E1|Reported Event|IC51 Booster Group|IC51, 6 mcg, intramuscular (i.m.) booster vaccination 15 months after the primary immunization in study IC51-309
409932|NCT00595270|B4|Baseline|Total|Total of all reporting groups
409933|NCT00595270|B3|Baseline|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
409934|NCT00595270|B2|Baseline|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
409935|NCT00595270|B1|Baseline|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
409936|NCT00595270|P3|Participant Flow|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
409937|NCT00595270|P2|Participant Flow|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
409938|NCT00595270|P1|Participant Flow|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
409939|NCT00595270|O3|Outcome|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
409940|NCT00595270|O2|Outcome|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
409941|NCT00595270|O1|Outcome|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
409942|NCT00595270|E3|Reported Event|IC51 1 x 6 µg|treatment group in preceeding study IC51-304
409943|NCT00595270|E2|Reported Event|IC51 1 x 12 µg|treatment group in preceeding study IC51-304
409944|NCT00595270|E1|Reported Event|IC51 2 x 6 µg|treatment group in preceeding study IC51-304
409945|NCT00595153|B4|Baseline|Total|Total of all reporting groups
409946|NCT00595153|B3|Baseline|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409947|NCT00595153|B2|Baseline|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409948|NCT00595153|B1|Baseline|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
409949|NCT00595153|P3|Participant Flow|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409950|NCT00595153|P2|Participant Flow|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409951|NCT00595153|P1|Participant Flow|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
409952|NCT00595153|O3|Outcome|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409953|NCT00595153|O2|Outcome|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409954|NCT00595153|O1|Outcome|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
409955|NCT00595153|E3|Reported Event|Asthmatics on ICS Treatment|"Asthmatics, who are already on inhaled corticosteroids who will be put on standardized dose of inhaled corticosteroids~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409956|NCT00595153|E2|Reported Event|Steroid Naive Asthmatics|"Asthmatics not on inhaled corticosteroids who will be put on an inhaled steroid during the study~Pulmicort : inhaled powder of inhaled corticosteroid, 1 puff (180mcg) twice a day for 8-10 weeks"
409957|NCT00595153|E1|Reported Event|Healthy Control|Healthy, non-asthmatics who will not be put on any intervention
409958|NCT00595127|B1|Baseline|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
409959|NCT00595127|P1|Participant Flow|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
409960|NCT00595127|O1|Outcome|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
409961|NCT00595127|E1|Reported Event|Cyclophosphamide and Fludarabine|To evaluate a cytoreductive regimen using standard TBI & cyclophosphamide w/ addition of fludarabine, to prepare pts w/ Fanconi anemia for Tcell depleted, allogeneic hematopoietic stem cell transplant
409962|NCT00595114|B3|Baseline|Total|Total of all reporting groups
409963|NCT00595114|B2|Baseline|KIA 1|Participants from the KIA trial with severe asthma
409964|NCT00595114|B1|Baseline|MIA 1|Participants from the MIA trial with mild asthma
409965|NCT00595114|P2|Participant Flow|KIA 1|Participants from the KIA trial with severe asthma
409966|NCT00595114|P1|Participant Flow|MIA 1|Participants from the MIA trial with mild asthma
409967|NCT00595114|O2|Outcome|KIA 1|Participants from the KIA trial with severe asthma
409968|NCT00595114|O1|Outcome|MIA 1|Participants from the MIA trial with mild asthma
409969|NCT00595114|E2|Reported Event|KIA 1|Participants from the KIA trial with severe asthma
409970|NCT00595114|E1|Reported Event|MIA 1|Participants from the MIA trial with mild asthma
409971|NCT00595088|B1|Baseline|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409972|NCT00595088|P1|Participant Flow|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409973|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409974|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409975|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409976|NCT00595088|O1|Outcome|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409977|NCT00595088|E1|Reported Event|20 mg of BC-819/PEI|Six intravesical instillations of 20 mg of plasmid DNA (BC-819) complexed with PEI into the bladder of patients with intermediate-risk superficial bladder cancer [recurrent stages Ta (low or high grade) and T1 (low grade) TCC] who have failed prior intravesical therapies including BCG and/or chemotherapy.
409978|NCT00595075|B3|Baseline|Total|Total of all reporting groups
409979|NCT00595075|B2|Baseline|Placebo in First Crossover Period|Placebo will be given prior to a 2-hour nap
409980|NCT00595075|B1|Baseline|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
411276|NCT00592319|E1|Reported Event|Experiment|treated with both of PDL and Celecoxib
409982|NCT00595075|P1|Participant Flow|Ramelteon in First Crossover Period|Ramelteon 8 mg will be given prior to a 2-hour nap
409983|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409984|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409985|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409986|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409987|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409988|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409989|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409990|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409991|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409992|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409993|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409994|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409995|NCT00595075|O2|Outcome|Placebo|Placebo will be given prior to a 2-hour nap
409996|NCT00595075|O1|Outcome|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409997|NCT00595075|E2|Reported Event|Placebo|Placebo will be given prior to a 2-hour nap
409998|NCT00595075|E1|Reported Event|Ramelteon|Ramelteon 8 mg will be given prior to a 2-hour nap
409999|NCT00594958|B4|Baseline|Total|Total of all reporting groups
410000|NCT00594958|B3|Baseline|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410001|NCT00594958|B2|Baseline|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410002|NCT00594958|B1|Baseline|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410003|NCT00594958|P3|Participant Flow|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410004|NCT00594958|P2|Participant Flow|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410005|NCT00594958|P1|Participant Flow|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410006|NCT00594958|O3|Outcome|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410007|NCT00594958|O2|Outcome|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410008|NCT00594958|O1|Outcome|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410009|NCT00594958|E3|Reported Event|IC51 Group C|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410010|NCT00594958|E2|Reported Event|IC51 Group B|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410011|NCT00594958|E1|Reported Event|IC51 Group A|IC51 (JE‐PIV) 6 mcg i.m. with 2 injections (days 0 and 28) with a vaccine produced from one out of three IC51 batches
410012|NCT00594945|B4|Baseline|Total|Total of all reporting groups
410013|NCT00594945|B3|Baseline|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|
410014|NCT00594945|B2|Baseline|Intranasal Clonazepam 3 mg|
410015|NCT00594945|B1|Baseline|Intranasal Clonazepam 2 mg|
410016|NCT00594945|P3|Participant Flow|Intranasal Clonazepam Both Dose Groups 2 mg & 3 mg|Subjects who were administered 2 mg during Cohort 1 and then 3 mg during Cohort 2
410017|NCT00594945|P2|Participant Flow|Intranasal Clonazepam 3 mg|Treatment administered to subjects during Cohort 2
410018|NCT00594945|P1|Participant Flow|Intranasal Clonazepam 2 mg|Treatment administered to subjects during Cohort 1
410019|NCT00594945|O2|Outcome|Intranasal Clonazepam 3 mg|
410020|NCT00594945|O1|Outcome|Intranasal Clonazepam 2 mg|
410021|NCT00594945|E2|Reported Event|Intranasal Clonazepam 3 mg|
410022|NCT00594945|E1|Reported Event|Intranasal Clonazepam 2 mg|
410023|NCT00594906|B3|Baseline|Total|Total of all reporting groups
410024|NCT00594906|B2|Baseline|Placebo|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
410025|NCT00594906|B1|Baseline|Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
410026|NCT00594906|P2|Participant Flow|Placebo Injection|"30 participants will receive placebo injection pens.~Placebo : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
410027|NCT00594906|P1|Participant Flow|Forteo Injection|"30 participants will receive teriparatide (Forteo) injection pens.~Teriparatide : Daily 20-mcg subcutaneous injections for the duration of the study (16 weeks)"
410028|NCT00594906|O2|Outcome|Forteo Patients|Patients who recieved Forteo Injections.
410029|NCT00594906|O1|Outcome|Placebo Patients|Patients who recieved Placebo injections.
410030|NCT00594906|E2|Reported Event|Placebo Injection|Patients who were randomized to Placebo
410031|NCT00594906|E1|Reported Event|Forteo Injection|Patients who randomized to the study drug, Forteo
410032|NCT00594880|B3|Baseline|Total|Total of all reporting groups
410033|NCT00594880|B2|Baseline|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410034|NCT00594880|B1|Baseline|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410035|NCT00594880|P2|Participant Flow|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410036|NCT00594880|P1|Participant Flow|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410037|NCT00594880|O2|Outcome|90 mcg/Week|Arm 2 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
410038|NCT00594880|O1|Outcome|180 mcg/Week|Arm 1 subjects with VL < 400 at week 12 of treatment who elected to continue study treatment for an additional 12 weeks
410039|NCT00594880|O2|Outcome|90 mcg/Week|Patients receiving 90 micrograms/week of pegylated interferon alpha-2a
410040|NCT00594880|O1|Outcome|180 mcg/Week|Patients receiving 180 micrograms/week of pegylated interferon alpha-2a
410041|NCT00594880|O2|Outcome|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410042|NCT00594880|O1|Outcome|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410043|NCT00594880|E2|Reported Event|Pegasys 90 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 90 mcg/week sc~Pegylated Interferon-alpha 2a, 90 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410044|NCT00594880|E1|Reported Event|Pegasys 180 mcg/Week|"ART replacement treatment with Pegylated Interferon-alpha 2a, 180 mcg/week sc~Pegylated Interferon-alpha 2a, 180 mcg/week sc : Pegylated Interferon-alpha 2a, 90 mcg/week sc for 24 weeks, 5 weeks in combination with ART, then 7 weeks without ART to primary endpoint (VL < 400 c/ml at 12 weeks) and further 12 weeks without ART (24 weeks) to secondary endpoints"
410045|NCT00594854|B3|Baseline|Total|Total of all reporting groups
410046|NCT00594854|B2|Baseline|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410047|NCT00594854|B1|Baseline|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410048|NCT00594854|P2|Participant Flow|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410049|NCT00594854|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410050|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410051|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410052|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410053|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410054|NCT00594854|O2|Outcome|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410055|NCT00594854|O1|Outcome|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410056|NCT00594854|E2|Reported Event|Arthrotec|diclofenac/misoprostol dosed twice daily (bid)
410057|NCT00594854|E1|Reported Event|PN400 (VIMOVO)|PN 400 (esomeprazole/naproxen) dosed twice daily (bid)
410058|NCT00594685|B1|Baseline|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410059|NCT00594685|P1|Participant Flow|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410060|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410061|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410062|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410063|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410064|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410065|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410066|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410067|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410068|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410069|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410070|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410071|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410072|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410073|NCT00594685|O1|Outcome|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410074|NCT00594685|E1|Reported Event|Isolated HIT|Hospitalized patients with isolated Heparin-Induced Thrombocytopenia (HIT), diagnosed by a fall in platelet count and a positive Platelet Factor 4 (PF4)-heparin Enzyme-Linked ImmunoSorbent Assay (ELISA) test
410075|NCT00594659|B4|Baseline|Total|Total of all reporting groups
410076|NCT00594659|B3|Baseline|3-tMET|"Therapist delivered motivational enhancement therapy (tMET)~Two session treatment with sessions delivered during weeks 1 and 4.~Two times per week urine drug testing.~Non-contingent incentives delivered for attending each urine testing appointment."
410077|NCT00594659|B2|Baseline|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computer delivered nine MET/CBT sessions during weeks 1-8 and week 12. therapist delivered 3 brief supportive counseling sessions during weeks 1, 4, and 12.~2 times per week urine drug testing.~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
410078|NCT00594659|B1|Baseline|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Nine weekly therapy sessions delivered in weeks 1-8 and week 12~2 times per week urine drug testing~Contingency management program delivered monetary-based incentives contingent on each marijuana-negative urine toxicology test."
410079|NCT00594659|P3|Participant Flow|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
410080|NCT00594659|P2|Participant Flow|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
410081|NCT00594659|P1|Participant Flow|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
410082|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
410083|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
410084|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
410085|NCT00594659|O3|Outcome|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment"
410086|NCT00594659|O2|Outcome|2-cMET/CBT/CM|"Computerized Cognitive Behavioral treatment~Computerized Psychotherapy : Nine session computer delivered treatment"
410087|NCT00594659|O1|Outcome|1-tMET/CBT/CM|"Therapist delivered cognitive behavioral treatment~Psychotherapy : Nine session treatment"
410088|NCT00594659|E3|Reported Event|3-tMET|"Motivational enhancement therapy~Motivational enhancement therapy : Two session treatment~2x/wk urine drug testing~non-contingent vouchers"
410089|NCT00594659|E2|Reported Event|2-cMET/CBT/CM|"Computer-delievered (c) MET/CBT/CM treatment~Computerized Psychotherapy : Nine session computer delivered treatment~2 times per week urine drug testing"
410090|NCT00594659|E1|Reported Event|1-MET/CBT/CM|"Therapist delivered motivational enhancement therapy plus cognitive behavioral therapy plus contingency management (tMET/CBT/CM)~Psychotherapy : Nine session treatment (wks 1-8 and wk 12)~2x/wk urine drug testing~Contingency Management voucher program"
410091|NCT00594646|B1|Baseline|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
410092|NCT00594646|P1|Participant Flow|Group 1|Men or women, 18 years of age or older, who present within 72 hours of a potential non-occupational exposure to HIV-1.
410093|NCT00594646|O1|Outcome|Group 1|TRUVADA (tenofovir DF 300mg + emtricitabine 200mg) + raltegravir (400mg)
410094|NCT00594646|O1|Outcome|Group 1|TDF 300mg + FTC 200mg (TDF/FTC) once daily + raltegravir 400mg twice daily
410095|NCT00594646|E1|Reported Event|Group 1|TDF 300mg and FTC 200mg (TDF/FTC) once daily + raltegravir (400mg) twice daily
410096|NCT00594568|B4|Baseline|Total|Total of all reporting groups
410097|NCT00594568|B3|Baseline|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410098|NCT00594568|B2|Baseline|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410099|NCT00594568|B1|Baseline|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410100|NCT00594568|P3|Participant Flow|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410101|NCT00594568|P2|Participant Flow|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410102|NCT00594568|P1|Participant Flow|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410202|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410103|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410104|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410105|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410106|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410107|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410108|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410109|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410110|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410111|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410112|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410113|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410114|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410115|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410116|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410117|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410118|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410119|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410120|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410121|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410122|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410123|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410124|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410125|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410126|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410127|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410128|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410129|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410130|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410131|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410132|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410133|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410134|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410135|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410203|NCT00594464|O6|Outcome|Rotigotine 16 mg/24h|
410136|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410137|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410138|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410139|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410140|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410141|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410142|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410143|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410144|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410145|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410146|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410147|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410148|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410149|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410150|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410151|NCT00594568|O1|Outcome|LY450139|Participants received 60 milligram LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410152|NCT00594568|O1|Outcome|LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410153|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410154|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410155|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410156|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410157|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410158|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410159|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410160|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410161|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410162|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410163|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410164|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410165|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410166|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410167|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410168|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410169|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410170|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410171|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410172|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410173|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410174|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410175|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410176|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410177|NCT00594568|O3|Outcome|140 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410178|NCT00594568|O2|Outcome|100 mg LY450139|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily until Week 88.
410179|NCT00594568|O1|Outcome|Placebo|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410180|NCT00594568|E9|Reported Event|140 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 140 mg LY450139 initial treatment or delayed start or did not enter SFU.
410181|NCT00594568|E8|Reported Event|100 mg LY450139- SFU|For SFU, study drug had been stopped and period was optional to enter; Participants entered from 100 mg LY450139 initial treatment or delayed start or did not enter SFU.
410182|NCT00594568|E7|Reported Event|Placebo- Safety FU Period (SFU)|For SFU, study drug had been stopped and period was optional to enter; Participants entered from Placebo initial treatment or delayed start or did not enter SFU.
410183|NCT00594568|E6|Reported Event|140 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410184|NCT00594568|E5|Reported Event|100 mg LY450139 - DO|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
410185|NCT00594568|E4|Reported Event|Placebo - Delayed Start Period (DO)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 mg orally once daily until Week 88.
410186|NCT00594568|E3|Reported Event|140 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks, followed by 100 mg LY450139 orally once daily for 2 weeks, then 140 mg LY450139 orally once daily until Week 88.
410187|NCT00594568|E2|Reported Event|100 mg LY450139 - NT|Participants received 60 mg LY450139 orally once daily for 2 weeks followed by gradual escalation to 100 mg LY450139 orally once daily until Week 88.
410188|NCT00594568|E1|Reported Event|Placebo - Initial Treatment Period (NT)|Participants received placebo orally once daily for the first 76 weeks. At the end of 76 weeks, placebo arm participants received LY450139 titrated up to 140 milligrams (mg) orally once daily until Week 88.
410189|NCT00594516|B1|Baseline|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
410190|NCT00594516|P3|Participant Flow|Tapentadol ER to IR|Tapentadol ER in first intervention period of double-blind phase and Tapentadol IR in second intervention period of double-blind phase
410191|NCT00594516|P2|Participant Flow|Tapentadol IR to ER|Tapentadol IR in first intervention period of double-blind phase and Tapentadol ER in second intervention period of double-blind phase
410192|NCT00594516|P1|Participant Flow|Tapentadol|Subjects treated in the Tapentadol(CG5503) Immediate Release (IR) Open-Label period
410193|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
410194|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
410195|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
410196|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
410197|NCT00594516|O1|Outcome|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) Open-Label period (followed by randomization to double-blind crossover maintenance period in which all subjects receive both IR and ER formulations)
410198|NCT00594516|E1|Reported Event|Tapentadol|Subjects treated in the Tapentadol Immediate Release (IR) open-label and the double-blind crossover period.
410199|NCT00594464|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410200|NCT00594464|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410201|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410204|NCT00594464|O5|Outcome|Rotigotine 14 mg/24h|
410209|NCT00594464|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410210|NCT00594464|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 16mg/24h at a dose left to the discretion of the neurologist.
410211|NCT00594425|B4|Baseline|Total|Total of all reporting groups
410212|NCT00594425|B3|Baseline|Vehicle PDT|
410213|NCT00594425|B2|Baseline|80 mg/g MAL PDT|
410214|NCT00594425|B1|Baseline|40 mg/g MAL PDT|
410215|NCT00594425|P3|Participant Flow|Vehicle PDT|
410216|NCT00594425|P2|Participant Flow|80 mg/g MAL PDT|
410217|NCT00594425|P1|Participant Flow|40 mg/g MAL PDT|
410218|NCT00594425|O3|Outcome|Vehicle PDT|
410219|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410220|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410221|NCT00594425|O3|Outcome|Vehicle PDT|
410222|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410223|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410224|NCT00594425|O3|Outcome|Vehicle PDT|
410225|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410226|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410227|NCT00594425|O3|Outcome|Vehicle PDT|
410228|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410229|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410230|NCT00594425|O3|Outcome|Vehicle PDT|
410231|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410232|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410233|NCT00594425|O3|Outcome|Vehicle PDT|
410234|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410235|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410236|NCT00594425|O3|Outcome|Vehicle PDT|
410237|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410238|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410239|NCT00594425|O3|Outcome|Vehicle PDT|
410240|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410241|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410242|NCT00594425|O3|Outcome|Vehicle PDT|
410243|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410244|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410245|NCT00594425|O3|Outcome|Vehicle PDT|
410246|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410247|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410248|NCT00594425|O3|Outcome|Vehicle PDT|
410249|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410250|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410251|NCT00594425|O3|Outcome|Vehicle PDT|
410252|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410253|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410254|NCT00594425|O3|Outcome|Vehicle PDT|
410255|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410256|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410257|NCT00594425|O3|Outcome|Vehicle PDT|
410258|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410259|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410260|NCT00594425|O3|Outcome|Vehicle PDT|
410261|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410262|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410263|NCT00594425|O3|Outcome|Vehicle PDT|
410264|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410265|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410266|NCT00594425|O3|Outcome|Vehicle PDT|
410267|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410268|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410269|NCT00594425|O3|Outcome|Vehicle PDT|
410270|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410271|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410272|NCT00594425|O3|Outcome|Vehicle PDT|
410273|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410274|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410275|NCT00594425|O3|Outcome|Vehicle PDT|
410276|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410277|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410278|NCT00594425|O3|Outcome|Vehicle PDT|
410279|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410280|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410281|NCT00594425|O3|Outcome|Vehicle PDT|
410282|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410283|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410284|NCT00594425|O3|Outcome|Vehicle PDT|
410285|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410286|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410287|NCT00594425|O3|Outcome|Vehicle PDT|
410288|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410289|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410290|NCT00594425|O3|Outcome|Vehicle PDT|
410291|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410292|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410293|NCT00594425|O3|Outcome|Vehicle PDT|
410294|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410295|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410296|NCT00594425|O3|Outcome|Vehicle PDT|
410297|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410298|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410299|NCT00594425|O3|Outcome|Vehicle PDT|
410300|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410301|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410302|NCT00594425|O3|Outcome|Vehicle PDT|
410303|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410304|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410305|NCT00594425|O3|Outcome|Vehicle PDT|
410306|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410307|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410308|NCT00594425|O3|Outcome|Vehicle PDT|
410309|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410310|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410311|NCT00594425|O3|Outcome|Vehicle PDT|
410312|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410313|NCT00594425|O1|Outcome|40 mg/g MAL PDT|
410314|NCT00594425|O3|Outcome|Vehicle PDT|
410315|NCT00594425|O2|Outcome|80 mg/g MAL PDT|
410328|NCT00594399|B1|Baseline|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410329|NCT00594399|P3|Participant Flow|Arm 3, Physical Activity Counseling, Reduced Dose|Upon rerandomization, individuals in this group continued to receive monthly physical activity counseling through 6 months which was then reduced to every other month during months 6-12.
410330|NCT00594399|P2|Participant Flow|Arm 2, Usual Care|Usual care from primary, womens or geriatric clinics
410331|NCT00594399|P1|Participant Flow|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410332|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410333|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410334|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410335|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410336|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410337|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410338|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410339|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410340|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410341|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410342|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410343|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410344|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
412017|NCT00589784|B1|Baseline|Aggressive Memingioma|Patients with Aggressive Memingioma
410345|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410346|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410347|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410348|NCT00594399|O2|Outcome|Arm 2|Usual care from primary, womens or geriatric clinics
410349|NCT00594399|O1|Outcome|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410350|NCT00594399|E2|Reported Event|Arm 2|Usual care from primary, womens or geriatric clinics
410351|NCT00594399|E1|Reported Event|Arm 1 Physical Activity Counseling|"Physical activity (PA) counseling program with the following components: baseline in-person counseling session; telephone calls, one physician endorsement of PA in a primary care clinic visit, monthly automated telephone calls from the primary care provider encouraging PA; and quarterly mailed materials providing personalized feedback.~Physical Activity Counseling: Physical activity (PA) counseling program with the following components: a baseline in-person counseling session; telephone calls biweekly for 6 weeks then monthly; one physician endorsement of PA in a primary care clinic visit; monthly automated telephone calls from the primary care provider encouraging PA; and (5) quarterly mailed materials providing personalized feedback."
410352|NCT00594386|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410353|NCT00594386|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410354|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410355|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410356|NCT00594386|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410357|NCT00594386|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410358|NCT00594308|B1|Baseline|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410359|NCT00594308|P1|Participant Flow|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410360|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410361|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410362|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410363|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410364|NCT00594308|O1|Outcome|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410365|NCT00594308|E1|Reported Event|Basiliximab 20 mg|All patients that received Basiliximab 20 mg monoclonal therapy
410366|NCT00594256|B1|Baseline|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
410367|NCT00594256|P1|Participant Flow|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
410368|NCT00594256|O1|Outcome|Sodium Oxybate|
410369|NCT00594256|O1|Outcome|Sodium Oxybate|
410370|NCT00594256|O1|Outcome|Sodiumn Oxybate|
410371|NCT00594256|O1|Outcome|Sodium Oxybate|
410372|NCT00594256|O1|Outcome|Sodium Oxybate|
410373|NCT00594256|E1|Reported Event|Sodium Oxybate (Open Label)|open label sodium oxybate treatment, beginning at 4.5 g/night and increasing weekly to a final dose of 9 g/night. Given in divided dose, half at bedtime and half 4 hours later (subjects were woken up)
410374|NCT00594230|B3|Baseline|Total|Total of all reporting groups
410423|NCT00594035|E2|Reported Event|Standard of Care|Subjects who receive standard or care meathods of dural sealing
410424|NCT00594035|E1|Reported Event|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
410375|NCT00594230|B2|Baseline|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410376|NCT00594230|B1|Baseline|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410377|NCT00594230|P2|Participant Flow|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410378|NCT00594230|P1|Participant Flow|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410379|NCT00594230|O2|Outcome|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410380|NCT00594230|O1|Outcome|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410381|NCT00594230|E2|Reported Event|Panobinostat 30 mg|Panobinostat(30 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410382|NCT00594230|E1|Reported Event|Panobinostat 20 mg|Panobinostat(20 mg PO) will be administered three times a week on Monday, Wednesday and Friday. Treatment will be given over 21 days followed by a 7 day rest period and repeated every 28 days. Patients will be assessed for toxicity on an ongoing basis and disease assessment will be determined every 2 treatment cycles (8 weeks). Patients will be allowed to continue on treatment for a maximum of eight four week treatment cycles. Treatment will be discontinued if there is evidence of disease progression, unacceptable toxicity and/or at the discretion of the investigator.
410383|NCT00594204|B3|Baseline|Total|Total of all reporting groups
410384|NCT00594204|B2|Baseline|Placebo|matching placebo following the same treatment schema as the varenicline group
410385|NCT00594204|B1|Baseline|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410386|NCT00594204|P2|Participant Flow|Placebo|matching placebo following the same treatment schema as the varenicline group
410387|NCT00594204|P1|Participant Flow|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410388|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
410389|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410390|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
410391|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410392|NCT00594204|O2|Outcome|Placebo|matching placebo following the same treatment schema as the varenicline group
410393|NCT00594204|O1|Outcome|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410394|NCT00594204|E2|Reported Event|Placebo|matching placebo following the same treatment schema as the varenicline group
410395|NCT00594204|E1|Reported Event|Varenicline|0.5 mg once daily (QD) for 3 days + 0.5 mg twice a day (BID) for 4 days, and then 1 mg BID for 11 weeks
410396|NCT00594178|B1|Baseline|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
410397|NCT00594178|P1|Participant Flow|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
410398|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
410399|NCT00594178|O1|Outcome|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
410400|NCT00594178|E1|Reported Event|Passive Exercise With Motorized Bicycle|The exercise was conducted from the subjects wheelchair with the feet attached to the bicycle by velcro straps and extra ankle dorsiflexion, provided by wedges on the pedal, to stretch the gastrocnemeus and soleus muscles. 60 minutes of exercise at with a goal of 60 rpm per training session. The exercise was conducted three times a week for 16 weeks or 5 times a week for 12 weeks, for an average of 50 sessions. Each subjects bone density and lean muscle mass was measured by DEXA scan, using a low radiation dose to determine the effect of exercise by comparing the subjects change in both parameters before the exercise and then after the exercise.
410401|NCT00594165|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410402|NCT00594165|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410403|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410404|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410405|NCT00594165|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410406|NCT00594165|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Year 1, the maximum dose allowed is 6 mg/24 hours. After Year 1, a dose increase is allowed up to a maximum of 16 mg/24 hours.
410407|NCT00594100|B1|Baseline|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410408|NCT00594100|P1|Participant Flow|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410409|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410410|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410411|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410412|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410413|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410414|NCT00594100|O1|Outcome|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410415|NCT00594100|E1|Reported Event|GFRS Pivotal Subjects|All non-training subjects using the GORE Flow Reversal System for embolic protection during carotid artery stenting (all subjects other than first two subjects accounted for in Training Cases).
410416|NCT00594035|B3|Baseline|Total|Total of all reporting groups
410417|NCT00594035|B2|Baseline|Standard of Care|Subjects who receive standard or care meathods of dural sealing
410418|NCT00594035|B1|Baseline|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
410419|NCT00594035|P2|Participant Flow|Standard of Care|Subjects who receive standard or care meathods of dural sealing
410420|NCT00594035|P1|Participant Flow|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
410421|NCT00594035|O2|Outcome|Standard of Care|Subjects who receive standard or care meathods of dural sealing
410422|NCT00594035|O1|Outcome|Spinal Sealant|Subjects that recieve DuraSeal Spinal Sealant
410426|NCT00594022|B2|Baseline|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410427|NCT00594022|B1|Baseline|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT (multiple sleep latency test) >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410428|NCT00594022|P2|Participant Flow|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410429|NCT00594022|P1|Participant Flow|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410430|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410431|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410432|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410433|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410434|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410435|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410436|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410454|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 5mg/kg/day treatment arm.
410568|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410437|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410438|NCT00594022|O2|Outcome|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410439|NCT00594022|O1|Outcome|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410440|NCT00594022|E2|Reported Event|"Group 2- VirtuSom- Sham"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with placebo / sham device (NO electric stimulation of the Vestibular nerve).~Electric stim of the Vestibular Nerve - VirtuSom - SHAM: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. For the Sham Group, NO electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes. This is a sham / placebo device only."
410441|NCT00594022|E1|Reported Event|"Group 1- VirtuSom - Stim"|"Normal sleepers (7.5 - 9.0 hours), MSLT >=14 min; phase-advance 5-hours studied under full polysomnogram (PSG) with active device (electric stimulation of the Vestibular nerve).~Electric stimulation of the Vestibular Nerve - VirtuSom: This device is similar to a Tens or Micro-Current electrical stimulator with respect to current levels deliver; however, because of the location of the stimulation it is similar to a Cranial Electrical Stimulator. A small electric stimulation (100 uA - 1000 uA) will be provided at the mastoids (bi-laterally) via small hydrogel electrodes."
410442|NCT00593957|B4|Baseline|Total|Total of all reporting groups
410443|NCT00593957|B3|Baseline|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410444|NCT00593957|B2|Baseline|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410445|NCT00593957|B1|Baseline|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410446|NCT00593957|P3|Participant Flow|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410447|NCT00593957|P2|Participant Flow|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410448|NCT00593957|P1|Participant Flow|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410449|NCT00593957|O2|Outcome|Total Sample SSI Mean Score at 6 Months|Study Sample Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
410450|NCT00593957|O1|Outcome|Total Sample SSI Mean Score at Baseline|Study Sample Screen for Social Interaction (SSI) mean core at baseline.
410451|NCT00593957|O6|Outcome|DM3 (5.0 mg/kg/Day) SSI 6 Months|DM3(5.0) mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
410452|NCT00593957|O5|Outcome|DM2 (2.5 mg/kg/Day) SSI 6 Months|DM2( 2.5 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
410453|NCT00593957|O4|Outcome|DM1( 0.25 mg/kg /Day) SSI 6 Months|DM1( 0.25 mg/kg /day)treatment arm Screen for Social Interaction (SSI) mean score at 6 months post-treatment.
412185|NCT00588692|B2|Baseline|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
410455|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 2.5 mg/kg/day treatment arm.
410456|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day) SSI Baseline|Screen for Social Interaction (SSI) mean score at baseline for Dextromethorphan 0.25 mg/kg per day treatment arm.
410457|NCT00593957|O3|Outcome|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410458|NCT00593957|O2|Outcome|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410459|NCT00593957|O1|Outcome|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410460|NCT00593957|O6|Outcome|DM3 EEG Spike Counts at 6 Months|DM3 group received Dextromethorphan 5mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at 6 months.
410461|NCT00593957|O5|Outcome|DM2 EEG Spike Counts at 6 Months|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at 6 months.
410462|NCT00593957|O4|Outcome|DM1 EEG Spike Count at 6 Months|DM1 group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at 6 months.
410463|NCT00593957|O3|Outcome|DM3 EEG Spike Counts at Baseline|"DM3 group received Dextromethorphan 5mg/kg/day.~The drug is given in two divided doses 12 hours apart for 6 months. EEG spike counts at baseline."
410464|NCT00593957|O2|Outcome|DM2 EEG Spike Counts at Baseline|DM2 group participants received Dextromethorphan 2.5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months. DM2 EEG spike counts at baseline.
410465|NCT00593957|O1|Outcome|Dextromethorphan (DM)1 EEG Spike Counts at Baseline|Dextromethorphan(DM)I group received Dextromethorphan 0.25 mg/kg per day. The drug is given in two divided doses 12 hours apart for 6 months. EEG spike count for DM1 group measured at baseline.
410466|NCT00593957|E3|Reported Event|DM3 (5mg/kg/Day)|"Dextromethorphan 5mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410467|NCT00593957|E2|Reported Event|DM2 (2.5 mg/kg/Day)|"Dextromethorphan 2.5 mg/kg/day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410468|NCT00593957|E1|Reported Event|DM1( 0.25 mg/kg /Day)|"Dextromethorphan 0.25 mg/kg per day~Dextromethorphan : Dextromethorphan polistirex. Doses are 0.25 mg/kg/day, 2.5mg/kg/day, and 5 mg/kg/day. The drug is given in two divided doses 12 hours apart for 6 months.~Dextromethorphan : Subjects will be randomized to receive one of three dosage groups either 0.25 mg/kg per day; or 2.5 mg/kg/day; or 5mg/kg/day of Dextromethorphan Polistirex (Delsym)oral syrup, which will be given exactly 12 hours apart in two divided doses during the 6 month trial."
410469|NCT00593918|B3|Baseline|Total|Total of all reporting groups
410470|NCT00593918|B2|Baseline|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
410471|NCT00593918|B1|Baseline|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
410472|NCT00593918|P2|Participant Flow|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
410473|NCT00593918|P1|Participant Flow|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
410474|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
410475|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
410476|NCT00593918|O2|Outcome|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
410477|NCT00593918|O1|Outcome|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
410478|NCT00593918|E2|Reported Event|Toll-like Receptor 4 AG/AA Genotypes|Toll-like Receptor 4 (TLR4) -2026/AG and AA control genotypes hypothesized to be associated with more inflammation during Respiratory syncytial virus (RSV) infection
410479|NCT00593918|E1|Reported Event|Toll-like Receptor 4 GG Genotype|Toll-like Receptor 4 (TLR4) -2026/GG gentoype hypothesized to be associated with less inflammation during Respiratory syncytial virus (RSV) infection
410480|NCT00593866|B1|Baseline|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
410481|NCT00593866|P1|Participant Flow|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
410482|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
410483|NCT00593866|O1|Outcome|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
410484|NCT00593866|E1|Reported Event|Radiation Dose Escalation With Gemcitabine|"INTENSITY MODULATED RADIOTHERAPY~Radiation dose escalation:~Total dose Dose per fraction BED* Dose equivalent (1.8 Gy/fraction) Level 1 45.0 1.8 53.1 45.0 Level 2 50.0 2.0 60.0 50.4 Level 3 52.5 2.1 63.5 54.0 Level 4 55.0 2.2 67.1 57.0 Level 5 57.5 2.3 70.7 60.0 Level 6 60.0 2.4 74.4 63.0 Level 7 62.5 2.5 78.1 66.2 Level 8 65.0 2.6 81.9 69.4~BED=Biological Effective Dose; =10 Five fractions weekly, fraction size determined by dose level~Gemcitabine:~1000mg/m2 will be infused over 100 minutes on days 1, 8, 22 and 29 of the radiation treatment"
410485|NCT00593827|B3|Baseline|Total|Total of all reporting groups
410486|NCT00593827|B2|Baseline|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410487|NCT00593827|B1|Baseline|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410488|NCT00593827|P2|Participant Flow|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410489|NCT00593827|P1|Participant Flow|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410490|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410491|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410492|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410493|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410494|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410495|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410496|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410497|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410498|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410499|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410500|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410501|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410502|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410503|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410504|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410505|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410506|NCT00593827|O2|Outcome|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410507|NCT00593827|O1|Outcome|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410508|NCT00593827|E2|Reported Event|Ixabepilone 40 mg/m^2|ixabepilone 40 mg/m^2 every 3 weeks
410509|NCT00593827|E1|Reported Event|Ixabepilone 16 mg/m^2|ixabepilone 16 mg/m^2 weekly for 3 weeks followed by 1 week rest
410510|NCT00593814|B3|Baseline|Total|Total of all reporting groups
410511|NCT00593814|B2|Baseline|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
410512|NCT00593814|B1|Baseline|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
410513|NCT00593814|P2|Participant Flow|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
410514|NCT00593814|P1|Participant Flow|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
410567|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410515|NCT00593814|O2|Outcome|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
410516|NCT00593814|O1|Outcome|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
410517|NCT00593814|E2|Reported Event|Original EXCLUDER|Historical Sample from original study of EXCLUDER Device. The original EXCLUDER Device was designed for the endovascular treatment of abdominal aortic aneurysms.
410518|NCT00593814|E1|Reported Event|EXCLUDER Low Permeability|Modified EXCLUDER device with Low Permeability Layer designed to treat abdominal aortic aneurysms with an endovascular surgical technique. This device functions identically to the original EXCLUDER device, however, a low permeability film is included in the device to eliminate migration of serous fluid through the graft.
410519|NCT00593736|B5|Baseline|Total|Total of all reporting groups
410520|NCT00593736|B4|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410521|NCT00593736|B3|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410522|NCT00593736|B2|Baseline|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410523|NCT00593736|B1|Baseline|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410524|NCT00593736|P4|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410525|NCT00593736|P3|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410526|NCT00593736|P2|Participant Flow|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410527|NCT00593736|P1|Participant Flow|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410528|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410529|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410530|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410531|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410532|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410533|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410534|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410535|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410536|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410537|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410538|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410539|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410540|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410541|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410542|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410543|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410544|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410545|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410546|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410547|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410548|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410549|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410550|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410551|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410552|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410553|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410554|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410555|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410556|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410557|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410558|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410559|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410560|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410561|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410562|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410563|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410564|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410565|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410566|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
416048|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
410569|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410570|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410571|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410572|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410573|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410574|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410575|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410576|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410577|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410578|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410579|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410580|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410581|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410582|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410583|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410584|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410585|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410586|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410587|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410588|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410589|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410590|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410591|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410592|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410593|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410594|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410595|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410596|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410597|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410598|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410599|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410600|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410601|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410602|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410603|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410604|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410605|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410606|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410607|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410608|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410609|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410610|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410611|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410612|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410613|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410614|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410615|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410616|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410617|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410618|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410619|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410620|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410621|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410622|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410623|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410624|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410625|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410626|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410627|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410628|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410629|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410630|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410631|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410632|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410633|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410634|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410635|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410636|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410637|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410638|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410639|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410640|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410641|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410642|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410643|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410644|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410645|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410646|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410647|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410648|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410649|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410650|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410651|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410652|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410653|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410654|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410655|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410656|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410657|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410658|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410659|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410660|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410661|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410662|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410663|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410664|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410665|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410666|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410667|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410668|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410669|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410670|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410671|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410672|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410673|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410674|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410675|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410676|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410677|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410678|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410679|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410680|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410681|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410682|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410683|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410684|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410685|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410686|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410687|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410688|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410689|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410690|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410691|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410692|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410693|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410694|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410695|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410696|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410697|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410698|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410699|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410700|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410701|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410702|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410703|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410704|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410705|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410706|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410707|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410708|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410709|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410710|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410711|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410712|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410713|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410714|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410715|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410716|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410717|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410718|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410719|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410720|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410721|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410722|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410723|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410724|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410725|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410726|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410727|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410728|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410729|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410730|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410731|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410732|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410733|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410734|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410735|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410736|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410737|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410738|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410739|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410740|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410741|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410742|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410743|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410744|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410745|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410746|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410747|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410748|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410749|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410750|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410751|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410752|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410753|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410754|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410755|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410756|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410757|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410758|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410759|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410760|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410761|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410762|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410763|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410764|NCT00593736|O4|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410765|NCT00593736|O3|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410766|NCT00593736|O2|Outcome|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410767|NCT00593736|O1|Outcome|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410768|NCT00593736|E4|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 2 weeks.
410769|NCT00593736|E3|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 2 weeks.
410770|NCT00593736|E2|Reported Event|Ramelteon 4 mg QD|Ramelteon 4 mg, tablets, orally, once daily for up to 2 weeks.
410771|NCT00593736|E1|Reported Event|Ramelteon 1 mg QD|Ramelteon 1 mg, tablets, orally, once daily for up to 2 weeks.
410772|NCT00593684|B3|Baseline|Total|Total of all reporting groups
410773|NCT00593684|B2|Baseline|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410774|NCT00593684|B1|Baseline|Algidex Patch|
410775|NCT00593684|P2|Participant Flow|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410776|NCT00593684|P1|Participant Flow|Algidex Patch|
410777|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410778|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
410779|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410780|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
410781|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410782|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
410783|NCT00593684|O2|Outcome|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410784|NCT00593684|O1|Outcome|Algidex Patch|The group of patients that were randomized to receive the Algidex patch during the study.
410785|NCT00593684|E2|Reported Event|Control|Infants in this group served as the control group and received line-dressing changes every 7 days according to standard hospital protocol specific for the type of line inserted. Insertion sites were covered with only an occlusive dressing (Tegaderm, Opsite).
410786|NCT00593684|E1|Reported Event|Algidex Patch|
410787|NCT00593645|B1|Baseline|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
411219|NCT00592488|O1|Outcome|Acetyl-L-Carnitine (ALC) Then Placebo|ALC for hours 0-12 and placebo hours 12-18
410788|NCT00593645|P1|Participant Flow|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410789|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410790|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410791|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410792|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410793|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410794|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410795|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410796|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410797|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410798|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410799|NCT00593645|O1|Outcome|Arm 1: Non-myeloablative Conditioning Regimen|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410800|NCT00593645|E1|Reported Event|Arm 1|"Clofarabine 40mg/m2/day IV over two hours daily x 5 days on Days -6 thru -2~Cytarabine 1gm/m2/day IV over two hours daily x 5 days on Days -6 thru -2 after the START of Clofarabine.~Thymoglobulin 1.0mg/kg IV over 6 hours X 1 day on Day -4, then 2.5mg/kg/day x 2 days on Days -3 and -2.~Stem Cell Transplant - On day 0 a minimum of total CD34+ cell dose of 2 x10E6/kg (actual weight of recipient) will be infused."
410801|NCT00593606|B1|Baseline|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410802|NCT00593606|P1|Participant Flow|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410803|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410804|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410805|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
416049|NCT00577135|O4|Outcome|High Intensification|
410806|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410807|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410808|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410809|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410810|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410811|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410812|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410813|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410814|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410815|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410816|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410817|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410818|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410819|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410820|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410821|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410822|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410823|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410824|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410825|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410826|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410827|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410828|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410829|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410830|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410831|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410832|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410833|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410834|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410835|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410836|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410837|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
416050|NCT00577135|O3|Outcome|Low Intensification|
410838|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410839|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410840|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410841|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410842|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410843|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410844|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410845|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410846|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410847|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410848|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410849|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410850|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410851|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410852|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410853|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410854|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410855|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410856|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410857|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410858|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410859|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410860|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410861|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410862|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410863|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410864|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410865|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410866|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410867|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410868|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410869|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
416051|NCT00577135|O2|Outcome|Continuous Infusion|
410870|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410871|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410872|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410873|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410874|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410875|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410876|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410877|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410878|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410879|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410880|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410881|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410882|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410883|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410884|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410885|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410886|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410887|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410888|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410889|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410890|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410891|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410892|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410893|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410894|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410895|NCT00593606|O1|Outcome|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410896|NCT00593606|E1|Reported Event|Rotigotine|Patients were dispensed rotigotine patches up to 8mg/24h at a dose considered by the investigator to be equivalent to the dose of ropinirole that the subject was currently taking.
410897|NCT00593450|B5|Baseline|Total|Total of all reporting groups
410898|NCT00593450|B4|Baseline|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410899|NCT00593450|B3|Baseline|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410900|NCT00593450|B2|Baseline|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410901|NCT00593450|B1|Baseline|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410902|NCT00593450|P4|Participant Flow|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
416052|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
410903|NCT00593450|P3|Participant Flow|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410904|NCT00593450|P2|Participant Flow|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410905|NCT00593450|P1|Participant Flow|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410906|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410907|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410908|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410909|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410910|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410911|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410912|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410913|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410914|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410915|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410916|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410917|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410918|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410919|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410920|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410921|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410922|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410923|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410924|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410925|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410926|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410927|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410928|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410929|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410930|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410931|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410932|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410933|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410934|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410935|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410936|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410937|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
411220|NCT00592488|E2|Reported Event|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
410938|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410939|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410940|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410941|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410942|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410943|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410944|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410945|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410946|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410947|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410948|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410949|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410950|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410951|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410952|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410953|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410954|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410955|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410956|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410957|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410958|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410959|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410960|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410961|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410962|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410963|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410964|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410965|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410966|NCT00593450|O4|Outcome|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410967|NCT00593450|O3|Outcome|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410968|NCT00593450|O2|Outcome|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
410969|NCT00593450|O1|Outcome|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410970|NCT00593450|E4|Reported Event|4-Avastin as Needed|Avastin® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410971|NCT00593450|E3|Reported Event|3-Lucentis as Needed|Lucentis® on a variable dosing schedule for 2 years; i.e., after initial treatment, monthly evaluation for treatment based on signs of lesion activity.
410972|NCT00593450|E2|Reported Event|2-Avastin Monthly|Avastin® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Avastin® every 4 weeks or to variable dosing.
411221|NCT00592488|E1|Reported Event|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
410973|NCT00593450|E1|Reported Event|1-Lucentis Monthly|Lucentis® on a fixed schedule of every 4 weeks for 1 year; at 1 year, re-randomization to Lucentis® every 4 weeks or to variable dosing.
410974|NCT00593372|B3|Baseline|Total|Total of all reporting groups
410975|NCT00593372|B2|Baseline|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
410976|NCT00593372|B1|Baseline|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
410977|NCT00593372|P2|Participant Flow|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
410978|NCT00593372|P1|Participant Flow|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
410979|NCT00593372|O2|Outcome|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
410980|NCT00593372|O1|Outcome|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
410981|NCT00593372|E2|Reported Event|Continuing Medication Only|Participants continue on current medication and are assessed at beginning and end of study duration.
410982|NCT00593372|E1|Reported Event|Spaced Retrieval Therapy|Participants continue on current medication but participate in spaced retrieval memory training, as well.
410983|NCT00593346|B1|Baseline|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410984|NCT00593346|P1|Participant Flow|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410985|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410986|NCT00593346|O1|Outcome|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410987|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410988|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410989|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410990|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410991|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410992|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410993|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410994|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410995|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410996|NCT00593346|O1|Outcome|Accelerated Partial Breast Brachytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410997|NCT00593346|E1|Reported Event|Accelerated Partial Breast Bracytherapy|"Each patient will receive accelerated partial breast brachytherapy with multiple plane implant.~Patients will receive 3400 cGy delivered in 10 twice-daily fractions. Treatment is to be given over 5-7 days with a minimum of 6 hours separation between fractions."
410998|NCT00593333|B3|Baseline|Total|Total of all reporting groups
410999|NCT00593333|B2|Baseline|Trigen|
411000|NCT00593333|B1|Baseline|Standard Treatment|
411001|NCT00593333|P2|Participant Flow|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
411222|NCT00592475|B4|Baseline|Total|Total of all reporting groups
411223|NCT00592475|B3|Baseline|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411002|NCT00593333|P1|Participant Flow|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
411003|NCT00593333|O2|Outcome|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
411004|NCT00593333|O1|Outcome|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
411005|NCT00593333|E2|Reported Event|Group B|Trochanteric entry portal for the antegrade nailing was used for this group. These subjects received a TRigen Trochanteric Angegrade Nail (TAN) manufactured by Smith & Nephew that incorporates a 4 degree valgus bend in the proximal aspect of the nail.
411006|NCT00593333|E1|Reported Event|Group A|Piriformis fossa entry portal for the antegrade nailing was used for this group. Received either a TRIGEN antegrade femoral nail manufactured by Smith & Nephew (Memphis, Tennessee) or an Antegrade Femoral Nail manufactured by Synthes (West Chester, Pennsylvania)
411007|NCT00593320|B3|Baseline|Total|Total of all reporting groups
411008|NCT00593320|B2|Baseline|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411009|NCT00593320|B1|Baseline|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411010|NCT00593320|P2|Participant Flow|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411011|NCT00593320|P1|Participant Flow|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411012|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411013|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411014|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411015|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411016|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411017|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411018|NCT00593320|O2|Outcome|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411019|NCT00593320|O1|Outcome|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411020|NCT00593320|E2|Reported Event|Arm 2: High Dose|High-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 18Gy
411021|NCT00593320|E1|Reported Event|Arm 1: Low Dose|Low-dose arm Single-fraction Stereotactic Radiosurgery (SRS) to 14 Gy
411022|NCT00593112|B3|Baseline|Total|Total of all reporting groups
411023|NCT00593112|B2|Baseline|Control|Healthy Volunteer Control group
411024|NCT00593112|B1|Baseline|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411025|NCT00593112|P2|Participant Flow|Control|Healthy Volunteer Control group
411026|NCT00593112|P1|Participant Flow|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411027|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
411028|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411029|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
411030|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411031|NCT00593112|O2|Outcome|Control|Healthy Volunteer Control group
411032|NCT00593112|O1|Outcome|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411033|NCT00593112|E2|Reported Event|Control|Healthy Volunteer Control group
411034|NCT00593112|E1|Reported Event|OROS Methylphenidate|OROS = Osmotic-controlled Release Oral delivery System
411035|NCT00592943|B3|Baseline|Total|Total of all reporting groups
411036|NCT00592943|B2|Baseline|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411037|NCT00592943|B1|Baseline|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411038|NCT00592943|P2|Participant Flow|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411039|NCT00592943|P1|Participant Flow|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411040|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411041|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411042|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411043|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411044|NCT00592943|O2|Outcome|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411045|NCT00592943|O1|Outcome|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411046|NCT00592943|E2|Reported Event|Armodafinil (250mg)|One 250 mg orally administered dose of Armodafini before PET scan.
411047|NCT00592943|E1|Reported Event|Armodafinil (100mg)|One 100 mg orally administered dose of Armodafini before PET scan.
411048|NCT00592904|B5|Baseline|Total|Total of all reporting groups
411049|NCT00592904|B4|Baseline|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411115|NCT00592774|B5|Baseline|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
416053|NCT00577135|E4|Reported Event|High Intensification|
411050|NCT00592904|B3|Baseline|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411051|NCT00592904|B2|Baseline|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411052|NCT00592904|B1|Baseline|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411053|NCT00592904|P4|Participant Flow|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411054|NCT00592904|P3|Participant Flow|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411055|NCT00592904|P2|Participant Flow|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411056|NCT00592904|P1|Participant Flow|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411057|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411058|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411059|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411060|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411061|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411062|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411063|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411064|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411065|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411066|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411067|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411116|NCT00592774|B4|Baseline|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411275|NCT00592319|E2|Reported Event|Control|treatd with CO2 laser or microsurgery
411068|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411069|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411070|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411071|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411072|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411073|NCT00592904|O4|Outcome|PHN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411074|NCT00592904|O3|Outcome|Post Herpetic Neuralgia (PHN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411075|NCT00592904|O2|Outcome|PDN: Prior Treatment of Perampanel|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally QD, depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411076|NCT00592904|O1|Outcome|Painful Diabetic Neuropathy (PDN): Prior Treatment of Placebo|All subjects in this study received open-label perampanel, up-titrated in 2-mg increments from 2 mg/day to 12 mg/day. Subjects took 1 to 4 tablets orally once daily (QD), depending upon the subject's dose at that time. All subjects in this study previously completed a double-blind, placebo-controlled studies for PDN or PHN.
411077|NCT00592904|E4|Reported Event|Post Herpetic Neuralgia|The participants that were being treated for PHN in the double-blind study and received either placebo or perampanel.
411078|NCT00592904|E3|Reported Event|Painful Diabetic Neuropathy|The participants that were being treated for PDN in the double-blind study and received either placebo or perampanel.
411079|NCT00592904|E2|Reported Event|Perampanel|The participants that had previously received perampanel during the double-blind study.
411080|NCT00592904|E1|Reported Event|Placebo|The participants who had previously received placebo during the double-blind study.
411081|NCT00592852|B1|Baseline|Fluoxetine|
411082|NCT00592852|P1|Participant Flow|Fluoxetine|
411083|NCT00592852|O1|Outcome|Fluoxetine|
411084|NCT00592852|O1|Outcome|Fluoxetine|
411085|NCT00592852|E1|Reported Event|Fluoxetine|
411086|NCT00592839|B4|Baseline|Total|Total of all reporting groups
411087|NCT00592839|B3|Baseline|Placebo Daily|Placebo tablet daily orally
411088|NCT00592839|B2|Baseline|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411089|NCT00592839|B1|Baseline|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411090|NCT00592839|P3|Participant Flow|Placebo Daily|Placebo tablet daily orally
411091|NCT00592839|P2|Participant Flow|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411092|NCT00592839|P1|Participant Flow|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411093|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411094|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411095|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411096|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411097|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411098|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411099|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411100|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411101|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411102|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411103|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411104|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411105|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411106|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411107|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411108|NCT00592839|O3|Outcome|Placebo Daily|Placebo tablet daily orally
411109|NCT00592839|O2|Outcome|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411110|NCT00592839|O1|Outcome|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411111|NCT00592839|E3|Reported Event|Placebo Daily|Placebo tablet daily orally
411112|NCT00592839|E2|Reported Event|0.625 mg SCE-B Daily|SCE-B tablet 0.625 mg/day orally
411113|NCT00592839|E1|Reported Event|0.3 mg SCE-B Daily|SCE-B tablet 0.3 mg/day orally
411114|NCT00592774|B6|Baseline|Total|Total of all reporting groups
411117|NCT00592774|B3|Baseline|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411118|NCT00592774|B2|Baseline|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411119|NCT00592774|B1|Baseline|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411120|NCT00592774|P5|Participant Flow|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411121|NCT00592774|P4|Participant Flow|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411122|NCT00592774|P3|Participant Flow|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411123|NCT00592774|P2|Participant Flow|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411124|NCT00592774|P1|Participant Flow|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411125|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411126|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411127|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411128|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411129|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411130|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411131|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411132|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411133|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411134|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411135|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411136|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411137|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411138|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411139|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411140|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411141|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411142|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411143|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411218|NCT00592488|O2|Outcome|Placebo Then Acetyl-L-Carnitine (ALC)|Placebo for hours 0-6 then ALC for hours 6-18
411144|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411145|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411146|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411147|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411148|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411149|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411150|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411151|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411152|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411153|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411154|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411155|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411156|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411157|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411158|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411159|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411160|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411161|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411162|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411163|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411164|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411165|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411166|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411167|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411168|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411169|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411170|NCT00592774|O5|Outcome|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411171|NCT00592774|O4|Outcome|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411172|NCT00592774|O3|Outcome|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411173|NCT00592774|O2|Outcome|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411174|NCT00592774|O1|Outcome|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411175|NCT00592774|E5|Reported Event|Perampanel Cohort 2, 2- Week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 2‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411176|NCT00592774|E4|Reported Event|Perampanel Cohort 2, 1-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 1‑week intervals by 2mg steps to a total of 8mg or MTD and continued at this dose until Week 15)
411177|NCT00592774|E3|Reported Event|Placebo Cohort 2|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411178|NCT00592774|E2|Reported Event|Perampanel Cohort 1, 3-week Titration|Perampanel 8mg (Subjects started at 2mg/day at Baseline and were up‑titrated at 3‑week intervals by 2mg steps to a total of 8mg or MTD [maximum tolerated dose] and continued at this dose until Week 15)
411179|NCT00592774|E1|Reported Event|Placebo Cohort 1|Placebo (Cohort 1 and 2 differed only in timing of their scheduled visits. Cohort 1 was scheduled to visit every 3 weeks. Cohort 2 was scheduled to visit every week for the first 6 weeks and every 3 weeks thereafter)
411180|NCT00592761|B1|Baseline|Entire Study Population|This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
411181|NCT00592761|P2|Participant Flow|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411182|NCT00592761|P1|Participant Flow|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411183|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411184|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411185|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411186|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411187|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411188|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411189|NCT00592761|O2|Outcome|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411190|NCT00592761|O1|Outcome|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411191|NCT00592761|E2|Reported Event|Treatment Then No Treatment|Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
411192|NCT00592761|E1|Reported Event|No Treatment Then Treatment|Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
411193|NCT00592683|B3|Baseline|Total|Total of all reporting groups
411194|NCT00592683|B2|Baseline|Aripiprazole + Placebo|treatment with aripiprazole + placebo
411195|NCT00592683|B1|Baseline|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
411196|NCT00592683|P2|Participant Flow|Aripiprazole + Placebo|treatment with aripiprazole + placebo
411197|NCT00592683|P1|Participant Flow|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
411198|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
411199|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
411200|NCT00592683|O2|Outcome|Aripiprazole + Placebo|treatment with aripiprazole + placebo
411201|NCT00592683|O1|Outcome|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
411202|NCT00592683|E2|Reported Event|Aripiprazole + Placebo|treatment with aripiprazole + placebo
411203|NCT00592683|E1|Reported Event|Aripiprazole + Fish Oil|treatment with aripiprazole + fish oil
411204|NCT00592631|B3|Baseline|Total|Total of all reporting groups
411205|NCT00592631|B2|Baseline|Sham|Subjects used SHAM set at 0-2 cmH20 for 7-10 nights
411206|NCT00592631|B1|Baseline|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
411207|NCT00592631|P2|Participant Flow|Sham Treatment|Adults with stable asthma and normal spirometry used SHAM with a mask pressure Mask pressure between 0 and 2 cm H20 for 7 to 10 nights prior to the follow-up assessment.
411208|NCT00592631|P1|Participant Flow|Continuous Positivie Airway Pressure|Adult with stable asthma and normal spirometry used CPAP with a mask pressure between 8 and 10 cm H20 for 7 to 10 nights prior to the follow-up assessment.
411209|NCT00592631|O2|Outcome|Sham|Subjects used sham set at 0-2 cmH20 for 7-10 nights
411210|NCT00592631|O1|Outcome|CPAP|Subjects used CPAP set at 8-10 cmH20 for 7-10 nights.
411211|NCT00592631|E2|Reported Event|Sham|
411212|NCT00592631|E1|Reported Event|Continuous Positive Airway Pressure|
411213|NCT00592488|B3|Baseline|Total|Total of all reporting groups
411214|NCT00592488|B2|Baseline|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
411215|NCT00592488|B1|Baseline|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
411216|NCT00592488|P2|Participant Flow|ALC Then Placebo|ALC for first 12 hours then placebo for next 6 hours
411217|NCT00592488|P1|Participant Flow|Placebo Then ALC|Placebo for first 6 hours then ALC for 12 hours
411224|NCT00592475|B2|Baseline|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411225|NCT00592475|B1|Baseline|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411226|NCT00592475|P3|Participant Flow|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411227|NCT00592475|P2|Participant Flow|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411228|NCT00592475|P1|Participant Flow|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411229|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411230|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411231|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411232|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411233|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411234|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411235|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411236|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411237|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411238|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411239|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411240|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411241|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411242|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411243|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411244|NCT00592475|O3|Outcome|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411245|NCT00592475|O2|Outcome|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411246|NCT00592475|O1|Outcome|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411247|NCT00592475|E3|Reported Event|Regimen 3 Placebo|Placebo continuous intravenous infusion over 6.5 hours
411248|NCT00592475|E2|Reported Event|Regimen 2 Conivaptan 25 mg|Conivaptan intravenous loading dose (20 mg) + 5 mg continuous infusion over 6.5 hours
411249|NCT00592475|E1|Reported Event|Regimen 1 Conivaptan 12.5 mg|Conivaptan intravenous loading dose (10 mg) + 2.5 mg continuous infusion over 6.5 hours
411250|NCT00592384|B3|Baseline|Total|Total of all reporting groups
411251|NCT00592384|B2|Baseline|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
411252|NCT00592384|B1|Baseline|Placebo Control|placebo: identically encapsulated inactive substance
411253|NCT00592384|P2|Participant Flow|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
411254|NCT00592384|P1|Participant Flow|Placebo Control|placebo: identically encapsulated inactive substance
411255|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
411256|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
411257|NCT00592384|O2|Outcome|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
411258|NCT00592384|O1|Outcome|Placebo Control|placebo: identically encapsulated inactive substance
411259|NCT00592384|E2|Reported Event|Venlafaxine XR|venlafaxine XR: Once daily oral dose ranging from 37.5 mg up to 300 mg
411260|NCT00592384|E1|Reported Event|Placebo Control|placebo: identically encapsulated inactive substance
411261|NCT00592358|B1|Baseline|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
411262|NCT00592358|P1|Participant Flow|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
411263|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
411264|NCT00592358|O1|Outcome|Paliperidone|Open-label treatment with Paliperidone.
411265|NCT00592358|E1|Reported Event|Paliperidone|Open label treatment with Invega (Paliperidone) once daily, with dosage of 3mg per day, titrated in 3mg increments to a maximum of 6mg per day based on subject age, weight and tolerance.
411266|NCT00592319|B3|Baseline|Total|Total of all reporting groups
411267|NCT00592319|B2|Baseline|Experimental|treated with once-time PDL, followed by oral taking of 9-month Celecoxib, in 15 cases
411268|NCT00592319|B1|Baseline|Control|"treated with routine surgery (CO2 laser or cold microsurgery), in 15 cases"
411269|NCT00592319|P2|Participant Flow|Experimental|once-time PDL surgery at 6.0-8.0 W, followed by oral taking of Celecoxib (100mg,BID)for 9 months
411270|NCT00592319|P1|Participant Flow|Control|"once-time routine surgery with (either of CO2 laser at continue model and 10.0-20.0 W, or cold surgery with micro-instruments), in 15 subjects"
411271|NCT00592319|O2|Outcome|Experienment|treated with once-time PDL, followed by oral taking of Celebrex (100mg,BID) for 9 months
411272|NCT00592319|O1|Outcome|Control|"treated with once-time routine surgery (CO2 laser or cold microsurgery)"
411273|NCT00592319|O2|Outcome|Experiment|treated with both of once-time PDL and 9-month Celebrex
411274|NCT00592319|O1|Outcome|Control|treated with once-time routine surgery
416054|NCT00577135|E3|Reported Event|Low Intensification|
411277|NCT00592176|B1|Baseline|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
411278|NCT00592176|P1|Participant Flow|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
411279|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
411280|NCT00592176|O1|Outcome|Bevacizumab|Patients receiving bevacizumab treatment.
411281|NCT00592176|E1|Reported Event|Bevacizumab|The participants received an initial 0.5mL subconjunctival injection of bevacizumab(2.5mg/mL) beneath the pterygium at the limbus and again every month for a total of 3 injections.
411282|NCT00592072|B1|Baseline|Overall Number of Subjects|12 subjects started the study and 10 completed the study, however 11 subjects are reported in the baseline characteristics because one subjects withdrew before baseline data was collected.
411283|NCT00592072|P2|Participant Flow|Placebo Intervention First, Then MCT Intervention|A total of 40 grams of cherry-flavored water sweetened with sucralose is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
411284|NCT00592072|P1|Participant Flow|MCT Intervention First, Then Placebo|A total of 40 grams of medium-chain triglycerides (derived from coconut oil containing 67% octanoate, 27% decanaote, and 6% other fatty acids) is ingested at 25-min intervals with front loading of 20 grams then 10 grams twice
411285|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411286|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411287|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411288|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411289|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411290|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411291|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411292|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411293|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411294|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411295|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411296|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411297|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411298|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411299|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411300|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411301|NCT00592072|O2|Outcome|Type 1 Diabetes Without MCT Oil|Subjects ingested a drink without MCT oil prior to euglycemic-hypoglycemic clamp.
411302|NCT00592072|O1|Outcome|Type 1 Diabetes With MCT Oil|Subjects ingested a drink containing MCT oil prior to euglycemic-hypoglycemic clamp.
411303|NCT00592072|E2|Reported Event|Placebo Intervention|
411304|NCT00592072|E1|Reported Event|MCT Intervention|
411305|NCT00591864|B1|Baseline|Study Participants|There are no arms or subgroups in this study.
411306|NCT00591864|P1|Participant Flow|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
411307|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
411308|NCT00591864|O1|Outcome|Participants Imaged With MBI and MRI|The group includes patients who underwent both MBI and breast MRI within the same 3 week period.
411309|NCT00591864|O1|Outcome|Study Participants|There are no arms or subgroups in this study.
411310|NCT00591864|E1|Reported Event|Study Participants|There are no arms or subgroups in this study.
411311|NCT00591851|B1|Baseline|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
411312|NCT00591851|P1|Participant Flow|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
411313|NCT00591851|O1|Outcome|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
411314|NCT00591851|E1|Reported Event|AC Followed by Paclitaxel + Trastuzumab|Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
411315|NCT00591773|B4|Baseline|Total|Total of all reporting groups
411316|NCT00591773|B3|Baseline|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411317|NCT00591773|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411318|NCT00591773|B1|Baseline|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411319|NCT00591773|P3|Participant Flow|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411320|NCT00591773|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411321|NCT00591773|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411322|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411323|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411324|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411325|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411326|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411327|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411328|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411329|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411330|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411331|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411332|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411333|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411334|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411335|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411336|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411337|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411338|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411339|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411340|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411341|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411342|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411343|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411344|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411345|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411346|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411347|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411348|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411349|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411350|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411351|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411352|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411353|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411354|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411355|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411356|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411357|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411358|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411359|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411360|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411361|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411362|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411363|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411364|NCT00591773|O3|Outcome|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411365|NCT00591773|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411366|NCT00591773|O1|Outcome|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411367|NCT00591773|E3|Reported Event|Chlorthalidone 25 mg QD|Chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411368|NCT00591773|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411369|NCT00591773|E1|Reported Event|Azilsartan Medoxomil 40 mg QD and Chlorthalidone 25 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily and chlorthalidone 25 mg, tablets, orally, once daily for up to 6 weeks.
411370|NCT00591760|B3|Baseline|Total|Total of all reporting groups
411371|NCT00591760|B2|Baseline|Control|Optimal CHF treatment
411372|NCT00591760|B1|Baseline|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
411373|NCT00591760|P2|Participant Flow|Control|Optimal CHF treatment
411374|NCT00591760|P1|Participant Flow|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
411375|NCT00591760|O2|Outcome|Control|Optimal CHF treatment
411376|NCT00591760|O1|Outcome|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
411377|NCT00591760|E2|Reported Event|Control|Optimal CHF treatment
411378|NCT00591760|E1|Reported Event|GH Replacement Therapy|Patients will receive 6 months of substitutive somatotropin (growth hormone) therapy at a dose of 0,00415 mg/kg a day, added to their background optimized CHF therapy
411379|NCT00591734|B1|Baseline|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
411380|NCT00591734|P1|Participant Flow|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
411381|NCT00591734|O1|Outcome|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
411382|NCT00591734|E1|Reported Event|Intervention|All patients received bevacizumab 15 mg/kg, administered by intravenous (IV) infusion on day 1 of each 21 day course. In addition, patients received everolimus 10 mg orally on a daily basis.
411383|NCT00591721|B3|Baseline|Total|Total of all reporting groups
411384|NCT00591721|B2|Baseline|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
411385|NCT00591721|B1|Baseline|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
411386|NCT00591721|P2|Participant Flow|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
411387|NCT00591721|P1|Participant Flow|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
411388|NCT00591721|O2|Outcome|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
411389|NCT00591721|O1|Outcome|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
411390|NCT00591721|E2|Reported Event|Wait List|Participants assigned to this arm waited 6 weeks after allocation to receive the intervention (teleconference fatigue management)
411391|NCT00591721|E1|Reported Event|Immediate Group|Participants assigned to this arm received the intervention (teleconference fatigue management) immediately after allocation.
411392|NCT00591591|B3|Baseline|Total|Total of all reporting groups
411393|NCT00591591|B2|Baseline|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411394|NCT00591591|B1|Baseline|Controls|Healthy controls
411395|NCT00591591|P2|Participant Flow|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411396|NCT00591591|P1|Participant Flow|Controls|Healthy controls
411397|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411398|NCT00591591|O1|Outcome|Controls|Healthy controls
411399|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411400|NCT00591591|O1|Outcome|Controls|Healthy controls
411401|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411402|NCT00591591|O1|Outcome|Controls|Healthy controls
411403|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411404|NCT00591591|O1|Outcome|Controls|Healthy controls
411405|NCT00591591|O2|Outcome|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411406|NCT00591591|O1|Outcome|Controls|Healthy controls
411407|NCT00591591|E2|Reported Event|Obsructive Sleep Apnea Sufferers|Patients undergoing sleep evaluation for suspected obstructive sleep apnea syndrome
411408|NCT00591591|E1|Reported Event|Controls|Healthy controls
411409|NCT00591578|B4|Baseline|Total|Total of all reporting groups
411410|NCT00591578|B3|Baseline|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411411|NCT00591578|B2|Baseline|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411412|NCT00591578|B1|Baseline|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).~Open Label Extension: Azilsartan medoxomil 40 mg, tablets, orally, once daily for 28 weeks. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411413|NCT00591578|P3|Participant Flow|Valsartan 320 mg QD|"Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411414|NCT00591578|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411415|NCT00591578|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411416|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411417|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411418|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411419|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411420|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411421|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411528|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411422|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411423|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411424|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411425|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411426|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411427|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411428|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411429|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411430|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411431|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411432|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411433|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411434|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411435|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411436|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411437|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411438|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411439|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411440|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411441|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411442|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411443|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411444|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411445|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411446|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411447|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411448|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411449|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411450|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411451|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411452|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411453|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411454|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411455|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411456|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411457|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411458|NCT00591578|O3|Outcome|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411459|NCT00591578|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.
411460|NCT00591578|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.
411461|NCT00591578|E4|Reported Event|Open Label Extension|Azilsartan medoxomil 40 mg, tablets, orally, independent of participant’s double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics).
411462|NCT00591578|E3|Reported Event|Valsartan 320 mg QD|Valsartan 80 mg, tablets, orally, once daily for 2 weeks; titrated to 320 mg, tablets, orally, once daily for up to 22 weeks.
411463|NCT00591578|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 80 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411464|NCT00591578|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|"Azilsartan medoxomil 20 mg, tablets, orally, once daily for 2 weeks; titrated to 40 mg, tablets, orally, once daily for up to 22 weeks.~Open Label Extension: At Week 24/completion of the double-blind treatment phase, participants could elect to continue in 28 week, open-label extension (OLE) phase. All participants who elected to participate in the OLE phase initiated treatment with azilsartan medoxomil 40 mg, tablets, orally, independent of their double-blind treatment assignment. Investigators may have added, in a step-wise fashion, hydrochlorothiazide 12.5 mg, followed by hydrochlorothiazide 25 mg, followed by other antihypertensive medications (except angiotensin II receptor blockers) as needed to achieve target blood pressure (<140/90 mm Hg or <130/80 mm Hg for diabetics)."
411465|NCT00591565|B1|Baseline|Acamprosate|acamprosate tablets
411466|NCT00591565|P1|Participant Flow|Acamprosate|acamprosate tablets
411467|NCT00591565|O1|Outcome|Acamprosate|
411468|NCT00591565|E1|Reported Event|Acamprosate|acamprosate tablets
411469|NCT00591370|B1|Baseline|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411470|NCT00591370|P1|Participant Flow|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411471|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411472|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411473|NCT00591370|O1|Outcome|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411474|NCT00591370|E1|Reported Event|Temozolomide (TMZ)|Temozolomide (TMZ) 75 mg/m2/day x 6 weeks every 8 weeks
411475|NCT00591344|B3|Baseline|Total|Total of all reporting groups
411476|NCT00591344|B2|Baseline|2 Flexibility Training|"25 PD subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
411477|NCT00591344|B1|Baseline|1 Progressive Resistance Training|"25 PD Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
411478|NCT00591344|P2|Participant Flow|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
411479|NCT00591344|P1|Participant Flow|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
411480|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment- L-dopa equilivent-mg/day
411481|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- L-dopa equilivent-mg/day
411482|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - on medication UPDRS part III, motor subscale score
411483|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- on medication UPDRS part III, motor subscale score
411484|NCT00591344|O2|Outcome|Progressive Resistance Exercise|Baseline Assessment - off medication UPDRS part III, motor subscale score
411485|NCT00591344|O1|Outcome|Modified Fitness Counts|Baseline Assessment- off medication UPDRS part III, motor subscale score
411486|NCT00591344|E2|Reported Event|2 Modified Fitness Counts|"Subjects performed between 60 and 90 minutes of flexibility training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercise inlcuded flexibility training. Participants exercised twice a week for 2 years doing flexibility training."
411526|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411527|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411487|NCT00591344|E1|Reported Event|1 Progressive Resistance Training|"Subjects performed between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions were supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.~Exercises included progressive resistance training. Participants exercised twice a week for 2 years doing progressive resistance training."
411488|NCT00591266|B4|Baseline|Total|Total of all reporting groups
411489|NCT00591266|B3|Baseline|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411490|NCT00591266|B2|Baseline|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411491|NCT00591266|B1|Baseline|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411492|NCT00591266|P3|Participant Flow|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411493|NCT00591266|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411494|NCT00591266|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411495|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411496|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411497|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411498|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411499|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411500|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411501|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411502|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411503|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411504|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411505|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411506|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411507|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411508|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411509|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411510|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411511|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411512|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411513|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411514|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411515|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411516|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411517|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411518|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411519|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411520|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411521|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411522|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411523|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411524|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411525|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
416055|NCT00577135|E2|Reported Event|Continuous Infusion|
411529|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411530|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411531|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411532|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411533|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411534|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411535|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411536|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411537|NCT00591266|O3|Outcome|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411538|NCT00591266|O2|Outcome|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411539|NCT00591266|O1|Outcome|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411540|NCT00591266|E3|Reported Event|Amlodipine 5 mg QD|Amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411541|NCT00591266|E2|Reported Event|Azilsartan Medoxomil 80 mg QD and Amlodipine 5 mg QD|Azilsartan Medoxomil 80 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411542|NCT00591266|E1|Reported Event|Azilsartan Medoxomil 40 mg QD Amlodipine 5 mg QD|Azilsartan Medoxomil 40 mg, tablets, orally, once daily and amlodipine 5 mg, tablets, orally, once daily for up to 6 weeks.
411543|NCT00591253|B4|Baseline|Total|Total of all reporting groups
411544|NCT00591253|B3|Baseline|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411545|NCT00591253|B2|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411546|NCT00591253|B1|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411547|NCT00591253|P3|Participant Flow|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411548|NCT00591253|P2|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411549|NCT00591253|P1|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411550|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411551|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411552|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411553|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411554|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411555|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411556|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411557|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411558|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411559|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411560|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411561|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411562|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411563|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411564|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411565|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411566|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411567|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411568|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411569|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411570|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411571|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411572|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411573|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411574|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
412317|NCT00588159|E2|Reported Event|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
411575|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411576|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411577|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411578|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411579|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411580|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411581|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411582|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411583|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411584|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411585|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411586|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411587|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411588|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411589|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411590|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411591|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411592|NCT00591253|O3|Outcome|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411593|NCT00591253|O2|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411594|NCT00591253|O1|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411595|NCT00591253|E3|Reported Event|Placebo QD|Azilsartan medoxomil placebo-matching tablets, orally, once daily for up to 6 weeks.
411596|NCT00591253|E2|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg, tablets, orally, once daily for up to 6 weeks.
411597|NCT00591253|E1|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg, tablets, orally, once daily for up to 6 weeks.
411598|NCT00591240|B3|Baseline|Total|Total of all reporting groups
411599|NCT00591240|B2|Baseline|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411600|NCT00591240|B1|Baseline|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411601|NCT00591240|P2|Participant Flow|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411602|NCT00591240|P1|Participant Flow|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411603|NCT00591240|O2|Outcome|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411604|NCT00591240|O1|Outcome|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411605|NCT00591240|E2|Reported Event|Antimicrobial Susceptibility Testing.|Urine samples of patients at risk of urinary tract infections were collected. Biosensor based antimicrobial susceptibility test, in concert with pathogen identification assay was directly performed on these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411606|NCT00591240|E1|Reported Event|Multiplex Identification of Pathogens.|Urine samples of patients at risk for urinary tract infections were collected. Biosensor based assays were used to detect the most common uropathogens in these samples. Analytical validity of the biosensor assays was examined by comparing biosensor results to those obtained using standard clinical microbiology laboratory methods. No interventions were performed.
411607|NCT00591227|B3|Baseline|Total|Total of all reporting groups
411670|NCT00591006|O4|Outcome|Placebo&Hydrocortisone|Examining all participants for the condition in which they took placebo and hydrocortisone.
416056|NCT00577135|E1|Reported Event|Q 12 Hour Bolus|
411608|NCT00591227|B2|Baseline|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
411609|NCT00591227|B1|Baseline|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
411610|NCT00591227|P2|Participant Flow|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
411611|NCT00591227|P1|Participant Flow|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
411612|NCT00591227|O2|Outcome|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
411613|NCT00591227|O1|Outcome|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
411614|NCT00591227|E2|Reported Event|2 Usual Care|these subjects will receive no insulin per protocol during their ER stay or during a possible inpatient admission. The care for their diabetes will be solely determined by the physician(s) in the ER and by the physician(s) caring for them in the hospital if they are admitted. They may receive no therapy, oral agents or insulin per primary physician preference.
411615|NCT00591227|E1|Reported Event|1-aspart Detemir|these subjects will be treated with insulin aspart every 2 hours if blood glucose is more than 200 mg/dl during their ER evaluation. If they are admitted to hospital then they will receive a weight-based dose of insulin detemir immediately prior to admission and then every 24 hours thereafter combined with mealtime doses of insulin aspart if they are eating.
411616|NCT00591214|B1|Baseline|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411617|NCT00591214|P1|Participant Flow|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411618|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411619|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411620|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411621|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411622|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411623|NCT00591214|O1|Outcome|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411624|NCT00591214|E1|Reported Event|MP-424|Drug: MP-424 750 mg every 8 hours for 12 weeks Other Name: Telaprevir
411625|NCT00591019|B1|Baseline|All Participants|Subjects were tested at baseline, then entered either the modafinil or placebo condtion and then the remaining condition.
411626|NCT00591019|P2|Participant Flow|Baseline, Placebo, Modafinil 200 mg/Day|Subjects are tested after baseline, then after taking a sugar pill once per day in the morning for 14 days, and then after taking modafinil 200 mg/day for 14 days.
411627|NCT00591019|P1|Participant Flow|Baseline, Modafinil 200 mg/Day, Placebo|Subjects are tested at baseline, then after Modafinil (200mg/day, a.m. administration) for 14 days, then after placebo (for 14 days).
411628|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
411629|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
411630|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
411631|NCT00591019|O3|Outcome|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
411632|NCT00591019|O2|Outcome|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
411633|NCT00591019|O1|Outcome|Baseline Testing.|Establish baseline levels of performance
411634|NCT00591019|E3|Reported Event|Placebo|Subjects are tested after taking a sugar pill once per day in the morning for 14 days.
411635|NCT00591019|E2|Reported Event|Modafinil|Subjects are tested after taking Modafinil (200mg/day, a.m. administration) for 14 days.
411636|NCT00591019|E1|Reported Event|Baseline Testing.|Establish baseline levels of performance
411637|NCT00591006|B1|Baseline|Total Study Population|Seventeen healthy controls, in a one-hour imaging session, received a structural MRI, MRS and fMRI scan four separate times with a 21 day washout between each study drug exposure in a crossover design. Prior to each scan each participant received placebo + placebo, phenytoin + placebo, hydrocortisone + placebo, or hydrocortisone + phenytoin in a random fashion. Thus, each participant received each of the four possible study drug combinations in a random order with an extended drug washout between each exposure. Hippocampal activation, volume and biochemistry, as well as mood and memory was assessed.
411671|NCT00591006|O3|Outcome|Phenytoin&Placebo|Examining all participants for the condition in which they took phenytoin and placebo.
411672|NCT00591006|O2|Outcome|Placebo&Placebo|Examining all participants for the condition in which they took placebo for both administrations.
411673|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Examining all participants for the condition in which they took both phenytoin and hydrocortisone.
411749|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411638|NCT00591006|P24|Participant Flow|PH + PL Then PL + H Then PL + PL Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411639|NCT00591006|P23|Participant Flow|PL + PL Then PH + H Then PL + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411640|NCT00591006|P22|Participant Flow|PL + PL Then PL + H Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411641|NCT00591006|P21|Participant Flow|PL + PL Then PL + H Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411642|NCT00591006|P20|Participant Flow|PL + PL Then PH + H Then PH + PL Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411643|NCT00591006|P19|Participant Flow|PL + PL Then PH + PL Then PL + H Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411644|NCT00591006|P18|Participant Flow|PH + PL Then PH + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411694|NCT00590902|P1|Participant Flow|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
411695|NCT00590902|O1|Outcome|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
411696|NCT00590902|E1|Reported Event|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
411697|NCT00590889|B3|Baseline|Total|Total of all reporting groups
411750|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411645|NCT00591006|P17|Participant Flow|PH + PL Then PH + H Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411646|NCT00591006|P16|Participant Flow|PH + PL Then PL + PL Then PL + H Then PH + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411647|NCT00591006|P15|Participant Flow|PH + PL Then PL + PL Then PH + H Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411648|NCT00591006|P14|Participant Flow|PH + H Then PL + PL Then PL + H Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411649|NCT00591006|P13|Participant Flow|PH + H Then PL + PL Then PH + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411650|NCT00591006|P12|Participant Flow|PH + H Then PH + PL Then PL + PL Then PL + H|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411651|NCT00591006|P11|Participant Flow|PH + H Then PL + H Then PH + PL Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411698|NCT00590889|B2|Baseline|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
411699|NCT00590889|B1|Baseline|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
411652|NCT00591006|P10|Participant Flow|PH + H Then PL + H Then PL + PL Then PH + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411653|NCT00591006|P9|Participant Flow|PL + H Then PH + PL Then PH + H Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411654|NCT00591006|P8|Participant Flow|PL + H Then PH + H Then PL + PL Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411655|NCT00591006|P7|Participant Flow|PL + H Then PH +H Then PH + PL Then PL + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411656|NCT00591006|P6|Participant Flow|PL + H Then PL + PL Then PH + H Then PH + PL|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by placebo. The imaging will be performed at 1300 hours.
411657|NCT00591006|P5|Participant Flow|PL + H Then PH + PL Then PL + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by placebo. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411658|NCT00591006|P4|Participant Flow|PL + H Then PL + PL Then PH + PL Then PH + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours (20mg) and 2100 hours (160mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking placebo tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin (400mg/day) followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take phenytoin followed by hydrocortisone. The imaging will be performed at 1300 hours.
411700|NCT00590889|P2|Participant Flow|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
411701|NCT00590889|P1|Participant Flow|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
416057|NCT00577122|B3|Baseline|Total|Total of all reporting groups
411659|NCT00591006|P3|Participant Flow|PL + PL Then PH + PL Then PH + H Then PL + H|Participants take two capsules containing placebo tablets by mouth at 0900 hours and 2100 hours for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets (400mg/day) followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take phenytoin followed by hydrocortisone (160mg/day). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours.
411660|NCT00591006|P2|Participant Flow|PH + H Then PH + PL Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by placebo. The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411661|NCT00591006|P1|Participant Flow|PH + PL Then PL + H Then PL + H Then PL + PL|Participants take two capsules containing phenytoin tablets by mouth at 0900 hours and 2100 hours (400 mg/day) for three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will repeat this cycle, instead taking phenytoin tablets followed by hydrocortisone (160 mg/day). The imaging will be performed at 1300 hours and participants washout for 21 days. Participants then take placebo followed by hydrocortisone. The imaging will be performed at 1300 hours. Participants washout for 21 days. Participants will then take placebo followed by placebo. The imaging will be performed at 1300 hours.
411662|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411663|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411664|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411665|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411666|NCT00591006|O4|Outcome|PBO&Hydrocortisone|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411667|NCT00591006|O3|Outcome|Phenytoin&PBO|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411668|NCT00591006|O2|Outcome|PBO&PBO|Participants will take two capsules containing placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the placebo), participants will begin taking 4 tablets of placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
411669|NCT00591006|O1|Outcome|Phenytoin&Hydrocortisone|Participants will take two capsules containing phenytoin tablets (100 mg) by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin), participants will begin taking 4 tablets containing hydrocortisone (20 mg) also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours.
416668|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
411674|NCT00591006|E4|Reported Event|Placebo, Then Placebo|"Hydrocortisone, Phenytoin~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
411675|NCT00591006|E3|Reported Event|Placebo, Then Hydrocortisone|"Hydrocortisone, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
411676|NCT00591006|E2|Reported Event|Phenytoin, Then Placebo|"Phenytoin, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
411677|NCT00591006|E1|Reported Event|Phenytoin, Then Hydrocortisone|"Placebo, Placebo~Phenytoin, Dilantin : participants will take two capsules containing phenytoin tablets (100 mg) or identical placebo by mouth at 0900 hours and 2100 hours (400 mg/day) for a total of three days with the last dose at 0900 hours on the day of the imaging (7 doses total). Beginning two days prior to the imaging (the day after initiating the phenytoin or placebo), participants will begin taking 4 tablets containing hydrocortisone (20 mg) or placebo also at 0900 hours and 2100 hours (160 mg/day) with the last dose at 0900 hours on the day of the imaging (5 doses total). The imaging will be performed at 1300 hours."
411678|NCT00590967|B3|Baseline|Total|Total of all reporting groups
411679|NCT00590967|B2|Baseline|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411680|NCT00590967|B1|Baseline|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin 40 mg/m^2"
411681|NCT00590967|P2|Participant Flow|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411682|NCT00590967|P1|Participant Flow|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on fluorodeoxyglucose (FDG) positron emission tomography (PET).~Intensity-modulated radiation therapy (IMRT) External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 high dose radiation (HDR) treatments)~Weekly cisplatin 40 mg/m^2"
411683|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411684|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411685|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411686|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411687|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411688|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411689|NCT00590967|O2|Outcome|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411690|NCT00590967|O1|Outcome|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411691|NCT00590967|E2|Reported Event|Treatment Group 2 (IMRT, Brachytherapy, Cisplatin)|"Para-Aortic Lymph Nodes Positive on FDG PET~IMRT (50.4 Gy to para-aortic lymph node bed with a 10.8 Gy boost to nodes)~IMRT external beam pelvic radiation therapy as appropriate for stage~Intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411692|NCT00590967|E1|Reported Event|Treatment Group 1 (IMRT, Brachytherapy, Cisplatin)|"Pelvic Lymph Nodes Only Positive on FDG PET.~IMRT External Beam radiation to the para-aortic region (45 Gy)~Pelvis intracavitary brachytherapy (6 HDR treatments)~Weekly cisplatin (40 mg/m^2)"
411693|NCT00590902|B1|Baseline|1 - OSI-774|OSI-774: erlotinib, TarcevaTM: 150 mg, 100 mg and 25 mg tablets
411702|NCT00590889|O2|Outcome|SJM Silzone|"SJM Masters Series Mechanical Heart Valve with Silzone Coating~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
411703|NCT00590889|O1|Outcome|SJM Conventional|"SJM Standard Masters Series Mechanical Heart Valve with Conventional Cuff~Artificial Mechanical Heart Valve: Both arms used market released mechanical heart valves in accordance with approved labeling"
411704|NCT00590889|E2|Reported Event|Adverse Events for the Silzone™ Group|These patients received the Silzone™ treated heart valve.
411705|NCT00590889|E1|Reported Event|Adverse Events for the Conventional Group|These patients received a conventional heart valve.
411706|NCT00590863|B4|Baseline|Total|Total of all reporting groups
411707|NCT00590863|B3|Baseline|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
411708|NCT00590863|B2|Baseline|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
411709|NCT00590863|B1|Baseline|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
411710|NCT00590863|P3|Participant Flow|Escitalopram + Placebo|Participants will take escitalopram (10 - 20 mg/day)+ placebo (1 to 3 pills per day). Medications taken orally. Participants will take escitalopram plus placebo for up to 28 weeks. Dosages were adjusted as need at each clinic visit.
411711|NCT00590863|P2|Participant Flow|Venlafaxine XR + Mirtazapine|Participant takes Venlafaxine XR (75 to 225 mg/day) + Mirtazapine (15 to 45 mg/day) for up to 28 weeks. Medications taken orally. Venlafaxine XR was blinded, and mirtazapine was given open label. Dosages were adjusted as need at each clinic visit.
411712|NCT00590863|P1|Participant Flow|Escitalopram + Bupropion SR|Participant takes Burpopion SR (150 to 450 mg/day)+ Escitalopram (10 to 20 mg/day) for up to 28 weeks. Medications taken orally. Bupropion SR was blinded, and escitalopram was given open label. Dosages were adjusted as need at each clinic visit.
411713|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
411714|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venalfaxine XR + Mirtazapine for up to 28 weeks.
411715|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
411716|NCT00590863|O3|Outcome|Escitalopram + Placebo|"Participants will take escitalopram plus placebo.~Escitalopram + placebo : Participants will take escitalopram plus placebo for up to 28 weeks."
411717|NCT00590863|O2|Outcome|Venlafaxine XR + Mirtazapine|Participants will take Venlafaine XR + Mirtazapine for up to 28 weeks.
411718|NCT00590863|O1|Outcome|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
411719|NCT00590863|E3|Reported Event|Escitalopram + Placebo|Participants will take Escitalopram + Placebo for up to 28 weeks.
411720|NCT00590863|E2|Reported Event|Venlafaxine XR + Mirtazapine|Participants will take Venlafaxine XR + Mirtazapine for up to 28 weeks.
411721|NCT00590863|E1|Reported Event|Escitalopram + Bupropion SR|Participants will take Escitalopram + BurpopionSR for up to 28 weeks.
411722|NCT00590772|B1|Baseline|Group 1|cross over
411723|NCT00590772|P1|Participant Flow|Group 1|subjects were randomized to placebo or active drug and then cross over to opposite; however, the details of the randomization are no longer available.
411724|NCT00590772|O2|Outcome|Placebo|
411725|NCT00590772|O1|Outcome|Montelukast|
411726|NCT00590772|E2|Reported Event|Placebo|
411727|NCT00590772|E1|Reported Event|Montelukast|
411728|NCT00590759|B1|Baseline|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
411729|NCT00590759|P1|Participant Flow|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
411730|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
411731|NCT00590759|O1|Outcome|Thoracic Endograft|GORE TAG® Thoracic Endoprosthesis: implant
411732|NCT00590759|E1|Reported Event|0502 TAG Device Subjects|
411733|NCT00590720|B3|Baseline|Total|Total of all reporting groups
411734|NCT00590720|B2|Baseline|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411735|NCT00590720|B1|Baseline|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411736|NCT00590720|P2|Participant Flow|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411737|NCT00590720|P1|Participant Flow|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411738|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411739|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411740|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411741|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411742|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411743|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411744|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411745|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411746|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411747|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411748|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411751|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411752|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411753|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411754|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411755|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411756|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411757|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411758|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411759|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411760|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411761|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411762|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411763|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411764|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411765|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411766|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411767|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411768|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411769|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411770|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411771|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411772|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411773|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411774|NCT00590720|O2|Outcome|MEDI528 50 mg|MEDI528 at a dose of 50 mg administered as a subcutaneous injection twice weekly for 4 weeks
411775|NCT00590720|O1|Outcome|PLACEBO|Placebo administered as a subcutaneous injection twice weekly for 4 weeks
411776|NCT00590720|E2|Reported Event|MEDI528 50 mg|
411777|NCT00590720|E1|Reported Event|PLACEBO|
411778|NCT00590590|B4|Baseline|Total|Total of all reporting groups
411779|NCT00590590|B3|Baseline|Placebo|Placebo administered twice weekly for 4 months
411780|NCT00590590|B2|Baseline|Lidocaine|Lidocaine administered twice weekly for 4 months
411781|NCT00590590|B1|Baseline|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411782|NCT00590590|P3|Participant Flow|Placebo|Placebo administered twice weekly for 4 months
411783|NCT00590590|P2|Participant Flow|Lidocaine|Lidocaine administered twice weekly for 4 months
411784|NCT00590590|P1|Participant Flow|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411785|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411786|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411787|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411788|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411789|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411790|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411791|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411792|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411793|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411794|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411795|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411796|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411797|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411798|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411799|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411800|NCT00590590|O3|Outcome|Placebo|Placebo administered twice weekly for 4 months
411801|NCT00590590|O2|Outcome|Lidocaine|Lidocaine administered twice weekly for 4 months
411802|NCT00590590|O1|Outcome|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411803|NCT00590590|E3|Reported Event|Placebo|Placebo administered twice weekly for 4 months
411804|NCT00590590|E2|Reported Event|Lidocaine|Lidocaine administered twice weekly for 4 months
411805|NCT00590590|E1|Reported Event|Lidocaine/Diphenhydramine (Combination)|Lidocaine/Diphenhydramine (Combination) administered twice weekly for 4 months
411806|NCT00590577|B5|Baseline|Total|Total of all reporting groups
411807|NCT00590577|B4|Baseline|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411808|NCT00590577|B3|Baseline|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411809|NCT00590577|B2|Baseline|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411810|NCT00590577|B1|Baseline|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411811|NCT00590577|P4|Participant Flow|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411812|NCT00590577|P3|Participant Flow|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411813|NCT00590577|P2|Participant Flow|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411814|NCT00590577|P1|Participant Flow|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411815|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411816|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411817|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411818|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411819|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411820|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411821|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411822|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411823|NCT00590577|O4|Outcome|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411824|NCT00590577|O3|Outcome|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411825|NCT00590577|O2|Outcome|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411826|NCT00590577|O1|Outcome|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411827|NCT00590577|E4|Reported Event|Placebo|Placebo on Day 1 (i.m., deltoid muscle) and Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411828|NCT00590577|E3|Reported Event|Paliperidone Palmitate 150 mg eq.|Paliperidone palmitate 150 mg eq. on Day 1 (i.m., deltoid muscle) and on Days 8, 36, and 64 (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator).
411829|NCT00590577|E2|Reported Event|Paliperidone Palmitate 100 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 100 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411830|NCT00590577|E1|Reported Event|Paliperidone Palmitate 25 mg eq.|Paliperidone palmitate 150 mg eq. (i.m., deltoid muscle) on Day 1, and 25 mg eq. (i.m., gluteal or deltoid muscle, left or right side, at the discretion of the investigator) on Days 8, 36, and 64.
411831|NCT00590564|B1|Baseline|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
411832|NCT00590564|P1|Participant Flow|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
411833|NCT00590564|O1|Outcome|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
411834|NCT00590564|E1|Reported Event|All Patients|Sho-saiko-to: All patients will receive treatment with 2.5grams of SST as granules in packet form by mouth three times a day every day for 52 weeks.
411835|NCT00590538|B1|Baseline|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411889|NCT00590226|B1|Baseline|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
411890|NCT00590226|P2|Participant Flow|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
416669|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
411836|NCT00590538|P1|Participant Flow|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411837|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411838|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411839|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411840|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411841|NCT00590538|O1|Outcome|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411842|NCT00590538|E1|Reported Event|Phenylbutyrate or Placebo|"Subjects will be randomized to receive either the Phenylbutyrate or placebo tablets for 4 days.~PLEASE NOTE: AT THE TIME OF TERMINATION BY PI, THE STUDY WAS NOT UNBLINDED SO IT IS NOT KNOWN WHICH PARTICIPANTS WERE ASSIGNED TO WHICH GROUP.~Every participant will receive Genistein during the Nasal Potential Difference (NPD)."
411843|NCT00590460|B1|Baseline|Group1|only one group
411844|NCT00590460|P1|Participant Flow|Allogeneic Stem Cell Transplant|only one group
411845|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411846|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411847|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411848|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411849|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411850|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411851|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411852|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411853|NCT00590460|O1|Outcome|Allogeneic Stem Cell Transplant|only one group
411854|NCT00590460|E1|Reported Event|Group1|only one group
411855|NCT00590369|B3|Baseline|Total|Total of all reporting groups
411856|NCT00590369|B2|Baseline|Versatile One|Versatile One (EZCare)negative wound therapy device
411857|NCT00590369|B1|Baseline|KCI VAC|KCI VAC type negative pressure wound therapy device
411858|NCT00590369|P2|Participant Flow|Versatile One|Versatile One (EZCare)negative wound therapy device
411859|NCT00590369|P1|Participant Flow|KCI VAC|KCI VAC type negative pressure wound therapy device
411860|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411861|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411862|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411863|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411864|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411865|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411866|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411867|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411868|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411869|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411870|NCT00590369|O2|Outcome|Versatile One|Versatile One (EZCare)negative wound therapy device
411871|NCT00590369|O1|Outcome|KCI VAC|KCI VAC type negative pressure wound therapy device
411872|NCT00590369|E2|Reported Event|Versatile One|Versatile One (EZCare)negative wound therapy device
411873|NCT00590369|E1|Reported Event|KCI VAC|KCI VAC type negative pressure wound therapy device
411874|NCT00590317|B3|Baseline|Total|Total of all reporting groups
411875|NCT00590317|B2|Baseline|Ondansetron|Patients receiving Ondansetron 4 mg IV
411876|NCT00590317|B1|Baseline|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
411877|NCT00590317|P2|Participant Flow|Ondansetron|Patients receiving Ondansetron 4mg IV
411878|NCT00590317|P1|Participant Flow|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
411879|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
411880|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10 mg IV
411881|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
411882|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
411883|NCT00590317|O2|Outcome|Ondansetron|Patients receiving Ondansetron 4mg IV
411884|NCT00590317|O1|Outcome|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
411885|NCT00590317|E2|Reported Event|Ondansetron|Patients receiving Ondansetron 4mg IV
411886|NCT00590317|E1|Reported Event|Prochlorperazine|Patients receiving Prochlorperazine 10mg IV
411887|NCT00590226|B3|Baseline|Total|Total of all reporting groups
411888|NCT00590226|B2|Baseline|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
411891|NCT00590226|P1|Participant Flow|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
411892|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
411893|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
411894|NCT00590226|O2|Outcome|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
411895|NCT00590226|O1|Outcome|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
411896|NCT00590226|E2|Reported Event|NPH+Regular|NPH insulin + regular insulin before breakfast and dinner
411897|NCT00590226|E1|Reported Event|Detemir + Aspart|Detemir insulin once daily + aspart insulin before meals
411898|NCT00590161|B3|Baseline|Total|Total of all reporting groups
411899|NCT00590161|B2|Baseline|Placebo TID|29 subjects received placebo as above for one year
411900|NCT00590161|B1|Baseline|Pentoxifylline (PTX) 400 mg PO (by Mouth) TID|26 subjects received PTX at dose above for one year
411901|NCT00590161|P2|Participant Flow|Placebo TID|29 subjects received placebo as above for one year
411902|NCT00590161|P1|Participant Flow|Pentoxifylline (PTX) 400 mg PO Three Times Daily (TID)|26 subjects received PTX at dose above for one year
411903|NCT00590161|O2|Outcome|Placebo Tid|29 subjects received placebo as above for one year
411904|NCT00590161|O1|Outcome|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
411905|NCT00590161|E2|Reported Event|Placebo Tid|29 subjects received placebo as above for one year
411906|NCT00590161|E1|Reported Event|Pentoxifylline 400 mg PO Tid|26 subjects received PTX at dose above for one year
411907|NCT00590044|B3|Baseline|Total|Total of all reporting groups
411908|NCT00590044|B2|Baseline|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
411909|NCT00590044|B1|Baseline|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
411910|NCT00590044|P2|Participant Flow|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
411911|NCT00590044|P1|Participant Flow|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
411912|NCT00590044|O2|Outcome|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
411913|NCT00590044|O1|Outcome|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
411914|NCT00590044|E2|Reported Event|NPH + Regular|Split-mixed NPH + Regular insulin twice daily
411915|NCT00590044|E1|Reported Event|Glargine (Lantus) + Glulisine|Daily insulin glargine (Lantus) + glulisine (Apidra) before meals
411916|NCT00590031|B1|Baseline|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
411917|NCT00590031|P1|Participant Flow|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
411918|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
411919|NCT00590031|O1|Outcome|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
411920|NCT00590031|E1|Reported Event|Combined Modality Therapy for Esophageal Carcinoma|The trial will be a phase II, single institution trial of preoperative therapy with irinotecan, cisplatin, and concurrent radiotherapy in surgically resectable esophageal cancer. The primary endpoint is the pathologic complete response rate to preoperative therapy, and a sample size of 50 patients will characterize this response rate +/- 13% with 95% confidence. Secondary endpoints will include the toxicity of therapy, including surgical morbidity and mortality, the overall and disease-free survival, pattern of disease recurrence, and quality of life achieved during therapy, including relief of dysphagia.
411921|NCT00590018|B3|Baseline|Total|Total of all reporting groups
411922|NCT00590018|B2|Baseline|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
411923|NCT00590018|B1|Baseline|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
411924|NCT00590018|P2|Participant Flow|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
411925|NCT00590018|P1|Participant Flow|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
411926|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
411927|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
411928|NCT00590018|O2|Outcome|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
411929|NCT00590018|O1|Outcome|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
411930|NCT00590018|E2|Reported Event|Placebo|Subjects in this arm will receive 5 days of placebo. Placebo: Placebo for 5 days intravenously.
411931|NCT00590018|E1|Reported Event|Hydrocortisone|Subjects in this arm will receive a 5 day tapering course of hydrocortisone. Hydrocortisone: Hydrocortisone taper (100mg/m2/day --> 25mg/m2/day) over 5 days intravenously.
411932|NCT00590005|B1|Baseline|Children With Asthma|The cohort consists of children with physician-diagnosed asthma across a wide range of severity (mild, moderate, severe)
411933|NCT00590005|P2|Participant Flow|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
411934|NCT00590005|P1|Participant Flow|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
411935|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
411936|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
411937|NCT00590005|O2|Outcome|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
411938|NCT00590005|O1|Outcome|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
411939|NCT00590005|E2|Reported Event|Children With Non-severe Asthma|This group includes child with physician-diagnosed asthma who did not meet criteria for severe asthma.
411940|NCT00590005|E1|Reported Event|Children With Severe Asthma|This group includes children with severe asthma diagnosed according to American Thoracic Society criteria (2000 workshop definition)
411941|NCT00589979|B3|Baseline|Total|Total of all reporting groups
411942|NCT00589979|B2|Baseline|Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
411943|NCT00589979|B1|Baseline|Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks.
411944|NCT00589979|P3|Participant Flow|Treatment Sequence: Placebo - Lidoderm - Lidoderm|Matching placebo 10cm X 14cm patches each on the front and back of the index knee q24h for up to 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411945|NCT00589979|P2|Participant Flow|Treatment Sequence: Lidoderm - Placebo - Placebo|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for up to 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411946|NCT00589979|P1|Participant Flow|Run-in Period: Lidoderm|Run-in Period with patients applying Lidoderm (lidocaine 5% patch) 10cm x 14cm each on the front and back of the index knee every 24 hours for up to 28 days (4 weeks).
411947|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411948|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411949|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411950|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411951|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411952|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411953|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411954|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411955|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411956|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
412013|NCT00589849|O1|Outcome|T Wave Altenans Stress Test|
412014|NCT00589849|E1|Reported Event|T Wave Altenans Stress Test|
411957|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411958|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411959|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411960|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching placebo 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411961|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411962|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411963|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411964|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411965|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411966|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411967|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411968|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411969|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411970|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411971|NCT00589979|O2|Outcome|Placebo Patch|The group represents the pooled data for all patients receiving Placebo patches during the randomized, double-blind treatment period regardless of the randomized study sequence.
411972|NCT00589979|O1|Outcome|Lidoderm (Lidocaine 5% Patch)|The group represents the pooled data for all patients receiving Lidoderm (lidocaine 5% patch) during the randomized, double-blind treatment period regardless of the randomized study sequence.
411973|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411974|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411975|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411976|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (Lidocaine 5% Patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411977|NCT00589979|O2|Outcome|Sequence: Placebo - Lidoderm - Lidoderm (PLL)|Matching placebo 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by Lidoderm (lidocaine 5% patch) 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411978|NCT00589979|O1|Outcome|Sequence: Lidoderm - Placebo - Placebo (LPP)|Lidoderm (lidocaine 5% patch) 10cm X 14cm patches each on the front and back of the index knee every 24 hours (q24h) for 4 weeks followed by matching 10cm x 14cm patches each on the front and back of the index knee q24h for up to 8 weeks
411979|NCT00589979|E3|Reported Event|Double-Blind Active Treatment Period With Placebo|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Placebo during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~**NOTE: two subjects randomized to the treatment sequence Lidoderm - Placebo - Placebo (PLL) discontinued from the study during treatment with Lidoderm (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Placebo) is equal to 91."
412015|NCT00589784|B3|Baseline|Total|Total of all reporting groups
412016|NCT00589784|B2|Baseline|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
411980|NCT00589979|E2|Reported Event|Double-Blind Treatment Period With Lidoderm|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the Double-blind Treatment Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated).~*NOTE: two subjects randomized to the treatment sequence Placebo - Lidoderm - Lidoderm (PLL) discontinued from the study during treatment with Placebo (Period 1); therefore, the number of subjects included in the safety analysis by treatment group (Lidoderm) is equal to 91."
411981|NCT00589979|E1|Reported Event|Run-In Period With Lidoderm (Lidocaine 5% Patch)|"Treatment-Emergent Adverse Events (TEAEs) reported by subjects on Lidoderm (lidocaine 5% patch) during the active treatment Run-in Period.~A treatment-emergent AE (TEAE) is any condition that was not present prior to treatment with study medication, but appeared following treatment, was present at treatment initiation, but worsened during treatment, or was present at treatment initiation, but resolved and then reappeared while the individual was on treatment (regardless of the intensity of the AE when the treatment was initiated)."
411982|NCT00589914|B3|Baseline|Total|Total of all reporting groups
411983|NCT00589914|B2|Baseline|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411984|NCT00589914|B1|Baseline|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411985|NCT00589914|P2|Participant Flow|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411986|NCT00589914|P1|Participant Flow|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411987|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411988|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411989|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411990|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411991|NCT00589914|O2|Outcome|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411992|NCT00589914|O1|Outcome|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411993|NCT00589914|E2|Reported Event|RISPERDAL CONSTA|Double-blind period. Flexible dose of 25, 37.5 or 50 mg administered by i.m. injection every 2 weeks up to Week 11 (Day 78).
411994|NCT00589914|E1|Reported Event|R092670|Double-blind period. Flexible dose of 50, 100 or 150 mg equivalent administered by i.m. injection every 4 weeks up to Week 9 (Day 64).
411995|NCT00589888|B1|Baseline|All Study Participants|"All participants received all 5 arms in random order:~0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours~Intralipid 20% @ 20cc/hr for 8 hours~Intralipid 20% @ 40cc/Hr for 8 hours~32-gram Oral Fat Load every 2 hours for 8 hours.~64-gram Oral Fat Loadevery 2 hours for 8 hours."
411996|NCT00589888|P5|Participant Flow|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
411997|NCT00589888|P4|Participant Flow|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
411998|NCT00589888|P3|Participant Flow|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
411999|NCT00589888|P2|Participant Flow|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
412000|NCT00589888|P1|Participant Flow|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
412001|NCT00589888|O1|Outcome|Oral 64-gram Fat Load|For the high (64 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
412002|NCT00589888|O1|Outcome|Oral 32-gram Fat Load|For the low (32 g fat) oral fat load studies, participants received fat with FFA composed of 33% polyunsaturated fatty acids, 34% monounsaturated fatty acids, and 22% saturated fatty acids. The oral fat load in either low or high dose was given in four equally divided doses at 0, 2, 4, and 6 h.
412003|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
412004|NCT00589888|O1|Outcome|Intralipid @ 20cc/Hour|Intralipid continuous IV infusion at 20cc/hour for 8 hours
412005|NCT00589888|O1|Outcome|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
412006|NCT00589888|E5|Reported Event|64-gram Oral Fat Load|"64-gram oral fat load~64-gram oral fat load: 60-gram oral fat load intake every 2 hours for 8 hours"
412007|NCT00589888|E4|Reported Event|32-gram Oral Fat Load|"32-gram oral fat load~32-gram oral fat load: oral liquid fat load prepared by the GCRC every 2 hours for 8 hours."
412008|NCT00589888|E3|Reported Event|Intralipid 20% @ 40cc/Hour|"Intralipid 20% IV infusion at 40cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 40cc/hour for 8 hours"
412009|NCT00589888|E2|Reported Event|Intralipid 20% @ 20cc/hr|"Intralipid 20% IV infusion at 20cc/hour~Intralipid 20%: Intralipid 20% IV continuous infusion at 20cc/hour for 8 hours"
412010|NCT00589888|E1|Reported Event|Normal Saline @ 40cc/Hour|"Normal Saline continuous IV infusion at 40cc/hour for 8 hours~0.9% Normal Saline: 0.9% Normal Saline continuous IV infusion at 40/cc for 8 hours"
412011|NCT00589849|B1|Baseline|T Wave Altenans Stress Test|
412012|NCT00589849|P1|Participant Flow|T Wave Altenans Stress Test|
412018|NCT00589784|P2|Participant Flow|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
412019|NCT00589784|P1|Participant Flow|Aggressive Memingioma|Patients with Aggressive Memingioma
412020|NCT00589784|O2|Outcome|Exploratory Cohort|Patients with WHO grade I meningioma, HPC and hemangioblastoma
412021|NCT00589784|O1|Outcome|Aggressive Memingioma|Patients with Aggressive Memingioma
412022|NCT00589784|E1|Reported Event|All Patients|All patients treated with Sunitinib (SU011248)
412023|NCT00589693|B3|Baseline|Total|Total of all reporting groups
412024|NCT00589693|B2|Baseline|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412025|NCT00589693|B1|Baseline|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412026|NCT00589693|P2|Participant Flow|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412027|NCT00589693|P1|Participant Flow|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412028|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412029|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412030|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412031|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412032|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412033|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412034|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412035|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412036|NCT00589693|O2|Outcome|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412037|NCT00589693|O1|Outcome|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412038|NCT00589693|E2|Reported Event|Imipenem-cilastatin|1 g 1-hour infusion intravenously every 8 hour for 10 days
412039|NCT00589693|E1|Reported Event|Doripenem|1 g 4-hour infusion intravenously every 8 hour for 7 days
412040|NCT00589667|B1|Baseline|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
412041|NCT00589667|P1|Participant Flow|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
412042|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
412043|NCT00589667|O1|Outcome|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
412044|NCT00589667|E1|Reported Event|Pemetrexed Plus Gemcitabine|Patients will receive pemetrexed (500 mg/m2 IV infusion over approximately 10 minutes) followed immediately by gemcitabine (1250 mg/m2 IV infusion given over approximately 30 minutes) on day 1 and day 15 of a 28-day cycle.
412045|NCT00589628|B3|Baseline|Total|Total of all reporting groups
412046|NCT00589628|B2|Baseline|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
412047|NCT00589628|B1|Baseline|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
412048|NCT00589628|P2|Participant Flow|Infliximab 10 mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
412049|NCT00589628|P1|Participant Flow|Infliximab 5 mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
412050|NCT00589628|O2|Outcome|Infliximab 10mg/kg|10mg/kg/dose of infliximab Iv at 4 week intervals
412051|NCT00589628|O1|Outcome|Infliximab 5mg/kg|5mg/kg/does of infliximab IV at 4 week intervals
412052|NCT00589628|E2|Reported Event|10 mg/kg of Infliximab|10mg/kg/dose of infliximab Iv at 4 week intervals
412053|NCT00589628|E1|Reported Event|5 mg/kg of Infliximab|5mg/kg/does of infliximab IV at 4 week intervals
412054|NCT00589563|B1|Baseline|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412055|NCT00589563|P1|Participant Flow|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412056|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412057|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412058|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412059|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412060|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412061|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412062|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412063|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412064|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412065|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412066|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412067|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412068|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412069|NCT00589563|O1|Outcome|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done.
412070|NCT00589563|E1|Reported Event|All Patients|All patients were analyzed as a single population. Stratification by conditioning regimen was not done. One patient did not have adverse event data collected.
412071|NCT00589550|B1|Baseline|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412072|NCT00589550|P1|Participant Flow|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412073|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412074|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412075|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412076|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412077|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412078|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412079|NCT00589550|O1|Outcome|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412080|NCT00589550|E1|Reported Event|Peginterferon Alfa-2b|"Peginterferon alfa-2b will be administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~PEG-interferon alfa-2b: administered SC on day 1 of each week of therapy. This will most likely be a Monday or a Tuesday. Sorafenib will be initiated on day 15 (start of week 3) of the first course and continued daily without breaks.~Sorafenib~gene expression analysis~polymerase chain reaction~reverse transcriptase-polymerase chain reaction~flow cytometry~immunoenzyme technique~laboratory biomarker analysis"
412081|NCT00589303|B3|Baseline|Total|Total of all reporting groups
412082|NCT00589303|B2|Baseline|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
412083|NCT00589303|B1|Baseline|Drug Therapy|FDA approved rate and rhythm control drugs
412084|NCT00589303|P2|Participant Flow|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
412085|NCT00589303|P1|Participant Flow|Drug Therapy|FDA approved rate and rhythm control drugs
412086|NCT00589303|O2|Outcome|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
412087|NCT00589303|O1|Outcome|Drug Therapy|FDA approved rate and rhythm control drugs
412088|NCT00589303|E2|Reported Event|Atrioventricular Node (AVN) Ablation / Pacing|Atrioventricular Node ablation and device implant
412089|NCT00589303|E1|Reported Event|Drug Therapy|FDA approved rate and rhythm control drugs
412090|NCT00589290|B1|Baseline|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
412091|NCT00589290|P1|Participant Flow|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
412092|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
412093|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
412094|NCT00589290|O1|Outcome|Belinostat|1000 mg/m^2 day, 30 minute intravenous infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
412095|NCT00589290|O2|Outcome|Thymic Patients|Poorly differentiated neoplasm
412096|NCT00589290|O1|Outcome|Thymoma Patients|Well differentiated neoplasm
412097|NCT00589290|E1|Reported Event|Belinostat Treatment|1000 mg/m^2/day as a 30 minute intravenous (IV) infusion daily for 5 days every 3 weeks (day 1-5 of the 3 week treatment cycle). After 12 cycles of treatment, cycles will be given for 5 days every 4 weeks.
412098|NCT00589277|B3|Baseline|Total|Total of all reporting groups
412099|NCT00589277|B2|Baseline|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412100|NCT00589277|B1|Baseline|Standard Care Counseling|Standard care counseling + standard care print information
412101|NCT00589277|P2|Participant Flow|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412102|NCT00589277|P1|Participant Flow|Standard Care Counseling|Standard care counseling + standard care print information
412103|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412104|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
412105|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412106|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
412107|NCT00589277|O2|Outcome|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412108|NCT00589277|O1|Outcome|Standard Care Counseling|Standard care counseling + standard care print information
412109|NCT00589277|E2|Reported Event|Gain-Framed Counseling|Callers were randomly assigned to receive standard care counseling and materials or were exposed to gain-framed counseling statements and received newly developed, exclusively gain-framed NYSSQL printed materials by mail.
412110|NCT00589277|E1|Reported Event|Standard Care Counseling|Standard care counseling + standard care print information
412111|NCT00589108|B4|Baseline|Total|Total of all reporting groups
412112|NCT00589108|B3|Baseline|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412113|NCT00589108|B2|Baseline|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412114|NCT00589108|B1|Baseline|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412115|NCT00589108|P3|Participant Flow|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412116|NCT00589108|P2|Participant Flow|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412117|NCT00589108|P1|Participant Flow|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412118|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412119|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412120|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412121|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412122|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412123|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412124|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412314|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412125|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412126|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412127|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412128|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412129|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412130|NCT00589108|O3|Outcome|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412131|NCT00589108|O2|Outcome|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412132|NCT00589108|O1|Outcome|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412133|NCT00589108|E3|Reported Event|All-Polyethylene Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System all polyethylene tray
412134|NCT00589108|E2|Reported Event|Modular-Metal-Backed Knee|Sigma Pressfit Condylar Posterior Cruciate Substituting System with a metal back tibial tray (fixed-bearing knee with the metal backed tray)
412135|NCT00589108|E1|Reported Event|Mobile-Bearing Knee|Sigma Knee System (mobile-bearing knee with the P.S. polyethylene insert)
412136|NCT00588965|B1|Baseline|All Subjects|Subjects will take propranolol LA 80 mg or placebo daily for one week then propranolol LA 160 mg for one week or 2 placebo pills, followed by the exercise test. The participants will be randomized to one of 2 sequences: placebo first or propranolol first.
412137|NCT00588965|P1|Participant Flow|All Participants|All participants were randomized to one of 2 sequences, in which they received either propranolol first, then placebo, or placebo first, then propranolol.
412138|NCT00588965|O2|Outcome|Propranolol|
412139|NCT00588965|O1|Outcome|Placebo|
412140|NCT00588965|O2|Outcome|Propranolol|
412141|NCT00588965|O1|Outcome|Placebo|
412142|NCT00588965|E2|Reported Event|Propranolol|Subjects will take propranolol LA 80 mg daily for one week then 160 mg for one week followed by the exercise test.
412143|NCT00588965|E1|Reported Event|Placebo|Subjects are assigned to placebo.
412144|NCT00588861|B3|Baseline|Total|Total of all reporting groups
412145|NCT00588861|B2|Baseline|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
412146|NCT00588861|B1|Baseline|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
412147|NCT00588861|P2|Participant Flow|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
412148|NCT00588861|P1|Participant Flow|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
412149|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
412150|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
412151|NCT00588861|O2|Outcome|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
412152|NCT00588861|O1|Outcome|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
412153|NCT00588861|E2|Reported Event|Answer Stem Utilizing Palacos Cement|Palacos Cement is bone cement used to secure artificial implants to bone that has a green color in order to improve visualization during implantation.
412154|NCT00588861|E1|Reported Event|Answer Stem Utilizing Simplex Cement|Simplex Cement is a bone cement used for implant fixation. It is a powder premixed with antibiotics
412155|NCT00588848|B3|Baseline|Total|Total of all reporting groups
412156|NCT00588848|B2|Baseline|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
412157|NCT00588848|B1|Baseline|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
412158|NCT00588848|P2|Participant Flow|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
412159|NCT00588848|P1|Participant Flow|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
412160|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
412161|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
412186|NCT00588692|B1|Baseline|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412162|NCT00588848|O2|Outcome|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
412163|NCT00588848|O1|Outcome|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
412164|NCT00588848|E2|Reported Event|CPAP|"Subject's own CPAP machine will be applied to the subject during the 8 hours overnight the first after surgery (study night)~Continuous Positive Airway Pressure (CPAP) : Subject's own CPAP unit is applied to the subject during the study night (the first night after surgery)"
412165|NCT00588848|E1|Reported Event|AUTOCPAP|"An Autoadjusting CPAP unit will be applied to the subject during the 8 hours overnight the first night after surgery (study night)~Autoadjusting Continuous Positive Airway Pressure (VPAP Auto) : An autoadjusting CPAP unit is used in place of subject's own CPAP unit during the night of the study (the first night after surgery)."
412166|NCT00588822|B1|Baseline|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412167|NCT00588822|P1|Participant Flow|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412168|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412169|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412170|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412171|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412172|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412173|NCT00588822|O1|Outcome|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412174|NCT00588822|E1|Reported Event|Rituximab|"Subjects will receive rituximab administered at the standard dose and schedule as an initial cycle of therapy, followed by a re-evaluation at 6 months. If the neuropathy is stable or responding at 6 months, the subject will receive Cycle 2 of rituximab, followed by a re-evaluation at 12 months.~Rituximab will be given as a 375 mg/m^2 intravenous infusion once weekly for four doses (days 1, 8, 15, and 22)."
412175|NCT00588809|B1|Baseline|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412176|NCT00588809|P1|Participant Flow|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412177|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412178|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412179|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412180|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412181|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412182|NCT00588809|O1|Outcome|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412183|NCT00588809|E1|Reported Event|Selumetinib|"Patients receive selumetinib PO BID on days 1 -28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~selumetinib: Given PO"
412184|NCT00588692|B3|Baseline|Total|Total of all reporting groups
412187|NCT00588692|P2|Participant Flow|SphygmoCor Blinded|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
412188|NCT00588692|P1|Participant Flow|SphygmoCor Unblinded|"The use of the sphygmocor values will determine medication adjustments to optimize heart failure (HF) treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-lide device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
412189|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412190|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412191|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412192|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412193|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412194|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412195|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412196|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412197|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412198|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412199|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412200|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412201|NCT00588692|O2|Outcome|Control|Sphygmocor values will be blinded to the investigator.
412202|NCT00588692|O1|Outcome|Treatment|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412203|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412204|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412205|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412206|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412207|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412208|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412209|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412210|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412211|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412212|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412213|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412214|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412215|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412216|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412217|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412218|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412219|NCT00588692|O2|Outcome|SphygmoCor Blinded|Sphygmocor values will be blinded to the investigator.
412220|NCT00588692|O1|Outcome|SphygmoCor Unblinded|The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.
412221|NCT00588692|E2|Reported Event|Control|"Sphygmocor values will be blinded to the investigator.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
412222|NCT00588692|E1|Reported Event|Treatment|"The use of the sphygmocor values will determine medication adjustments to optimize HF treatment.~SphygmoCor: The SphygmoCor, a hand-held tonometer will assess central blood pressure noninvasively. This pencil-like device is applied over the radial artery, and uses a validated mathematical transformation to derive central aortic pressure."
412223|NCT00588666|B1|Baseline|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
412246|NCT00588471|E1|Reported Event|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
412315|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412316|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412224|NCT00588666|P1|Participant Flow|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
412225|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
412226|NCT00588666|O1|Outcome|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
412227|NCT00588666|E1|Reported Event|Treatment|Bevacizumab, Carboplatin, Gemcitabine: Patients will initially receive bevacizumab 10 mg/kg followed by a 2 week treatment-free interval. Treatment will then begin with combination therapy. Gemcitabine 1000 mg/m2 will be administered intravenously on day 1 and 8 and carboplatin AUC 4.5 on day 1 with treatment recycled every 21 days. Bevacizumab will be administered at a dose of 15 mg/kg on day 1 of each 21-day cycle. Restaging evaluations will be performed after every 3 cycles of treatment (approximately 9 weeks). Patients will receive a total of 6 cycles of chemotherapy unless disease progression or unacceptable toxicity occurs. Patients who achieve stable disease, a partial response, or a complete response after completion of 6 cycles, will be eligible to continue bevacizumab at the same dose and schedule until disease progression for a maximum of 18 additional doses.
412228|NCT00588640|B1|Baseline|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
412229|NCT00588640|P1|Participant Flow|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
412230|NCT00588640|O1|Outcome|Phase I, Cohort l|"oral d-methadone 40 mg~d-Methadone: 8 subjects to receive 40 mg d-Methadone twice a day"
412231|NCT00588640|E1|Reported Event|Patients Receiving D-methadone 40 mg|Patient Receiving D-methadone 40 mg
412232|NCT00588536|B1|Baseline|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
412233|NCT00588536|P1|Participant Flow|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
412234|NCT00588536|O1|Outcome|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
412235|NCT00588536|E1|Reported Event|MTX, 6-TG and Leucovorin|"Methotrexate: MTX 30mg/m2 (or 1mg/kg for infants) orally, given in three equally divided doses at 0,8, and 16hrs~6-Thioguanine: 6-TG 300mg/m2 (or 10mg/kg for infants) orally, given in one dose.~Leucovorin Calcium: 5mg orally at 36,48, and 60hrs (or 12 hrs after the dose of 6-TG and then every 12 hrs for a total of 3 doses)"
412236|NCT00588471|B3|Baseline|Total|Total of all reporting groups
412237|NCT00588471|B2|Baseline|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
412238|NCT00588471|B1|Baseline|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
412239|NCT00588471|P2|Participant Flow|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
412240|NCT00588471|P1|Participant Flow|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
412241|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
412242|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
412243|NCT00588471|O2|Outcome|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
412244|NCT00588471|O1|Outcome|Simvastatin|Subjects randomized to this arm will be pretreated with 80 mg (2 pills) simvastatin approximately one hour prior to percutaneous coronary intervention.
412245|NCT00588471|E2|Reported Event|Placebo|Subjects randomized to this arm will be pretreated with 2 placebo pills approximately one hour prior to percutaneous coronary intervention.
412247|NCT00588445|B1|Baseline|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
412248|NCT00588445|P1|Participant Flow|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
412249|NCT00588445|O2|Outcome|EGFR Mutation Negative|Tumor specimens analyzed for EGFR mutation
412250|NCT00588445|O1|Outcome|EGFR Mutation Positive|Tumor specimens analyzed for EGFR mutation
412251|NCT00588445|O1|Outcome|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
412252|NCT00588445|E1|Reported Event|Treatment|"Gefitinib: Patients will receive gefitinib 250 mg po daily for at least 21 days preoperatively (depending on the timing of the surgery). Treatment with gefitinib will be stopped 2 days before the date of surgery.~Patients who have had at least a minor response to gefitinib therapy preoperatively (> 25% reduction in tumor measured bidimensionally) and / or have mutations in the protein-tyrosine kinase domain of the EGF receptor gene identified will continue on the study and will resume gefitinib treatment after at least 7 days from surgery providing adequate wound healing has occurred.~Patients who are determined to be candidates for adjuvant chemotherapy and/or radiation therapy by their treating physician may receive treatment with adjuvant chemotherapy and/or radiation therapy. The post-operative gefitinib will be started after completion of the chemotherapy and/or radiation therapy."
412253|NCT00588406|B3|Baseline|Total|Total of all reporting groups
412254|NCT00588406|B2|Baseline|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412255|NCT00588406|B1|Baseline|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412256|NCT00588406|P2|Participant Flow|Placob|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412257|NCT00588406|P1|Participant Flow|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412258|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412259|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412260|NCT00588406|O2|Outcome|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412261|NCT00588406|O1|Outcome|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412262|NCT00588406|E2|Reported Event|Placebo|"Placebo plus standard care~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412263|NCT00588406|E1|Reported Event|Budesonide|"Budesonide, 2mg, 4 doses, plus standard care~Budesonide: 2mg/dose by nebulizer, four doses over 3 hours~albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours~Ipratropium bromide: 2.5 mg, one dose~Prednisone: 60mg PO"
412264|NCT00588380|B1|Baseline|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
412265|NCT00588380|P1|Participant Flow|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
412266|NCT00588380|O1|Outcome|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
412267|NCT00588380|O1|Outcome|All Participants|C-peptide as a marker of insulin secretion
412268|NCT00588380|E1|Reported Event|Overall Study|All participants recieved glucose for 2 hours then Glucagon Like Peptide-1 (GLP-1) intravenously at a rate of 0.75 pmol/kg/min for 1 hour followed by 1.5 pmol/kg/min for the subsequent hour. The study lasted for 240 minutes.
412270|NCT00588354|B2|Baseline|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412271|NCT00588354|B1|Baseline|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412272|NCT00588354|P2|Participant Flow|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412273|NCT00588354|P1|Participant Flow|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412274|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412275|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412276|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412277|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412278|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412279|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412280|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412281|NCT00588354|O1|Outcome|2% Lidocaine and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412282|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412283|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412284|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412285|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412286|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412287|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412288|NCT00588354|O2|Outcome|2% Lidocaine and Triamcinolone (40 mg)|Transforaminal epidural steroid injection
412289|NCT00588354|O1|Outcome|2% Lidociane and Clonidine (200 or 400 ug)|Transforaminal epidural clonidine injection
412290|NCT00588354|E2|Reported Event|2% Lidocaine and Triamcinolone (40 mg).|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412291|NCT00588354|E1|Reported Event|2% Lidocaine and Clonidine (200 or 400 ug)|"Patients received one to three injections administered at about 2 weeks apart. Patients,investigators, and study coordinators were blinded to the treatment.~The primary outcome was an 11-point Pain Intensity Numerical Rating Scale at 1 month. Other outcomes included Patient Global Impression of Change and functional measures."
412292|NCT00588341|B1|Baseline|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
412293|NCT00588341|P1|Participant Flow|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
412294|NCT00588341|O1|Outcome|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
412295|NCT00588341|E1|Reported Event|Treatment|Temozolomide: Patients will then be treated with TMZ according to the extended dosing schedule of 75mg/m2/day x 6 weeks every 8 weeks.
412296|NCT00588237|B1|Baseline|All Patients|Paclitaxel, Cisplatin, Bevacizumab
412297|NCT00588237|P1|Participant Flow|All Patients|Paclitaxel, Cisplatin, Bevacizumab
412298|NCT00588237|O1|Outcome|All Patients|Paclitaxel, Cisplatin, Bevacizumab
412299|NCT00588237|E1|Reported Event|All Patients|Paclitaxel, Cisplatin, Bevacizumab
412300|NCT00588159|B3|Baseline|Total|Total of all reporting groups
412301|NCT00588159|B2|Baseline|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412302|NCT00588159|B1|Baseline|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412303|NCT00588159|P2|Participant Flow|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412304|NCT00588159|P1|Participant Flow|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412305|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412306|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412307|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412308|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412309|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412310|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412311|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412312|NCT00588159|O1|Outcome|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412313|NCT00588159|O2|Outcome|Active Placebo|Diphenhydramine 12.5 mg p.o. 2 hours preoperatively.
412318|NCT00588159|E1|Reported Event|Gabapentin Preoperatively|Preoperative gabapentin 600 mg p.o. within 2 hours prior to surgery.
412319|NCT00588146|B1|Baseline|Entire Study Population|Includes groups randomized to pegylated interferon alpha-2b first and standard care first.
412320|NCT00588146|P2|Participant Flow|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
412321|NCT00588146|P1|Participant Flow|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
412322|NCT00588146|O2|Outcome|Standard Care, Then Pegylated Interferon Alpha2b|Standard care for 6 months, then weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months.
412323|NCT00588146|O1|Outcome|Pegylated Interferon Alpha2b, Then Standard Care|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week for 6 months, then standard care for 6 months.
412324|NCT00588146|E2|Reported Event|Standard Care|Subjects received standard care for hereditary hemorrhagic telangiectasia.
412325|NCT00588146|E1|Reported Event|Pegylated Interferon Alpha-2b|Weekly subcutaneous injection of pegylated interferon alpha2b 1 microgram/kg/week
412326|NCT00588094|B1|Baseline|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
412327|NCT00588094|P1|Participant Flow|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
412328|NCT00588094|O1|Outcome|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
412329|NCT00588094|E1|Reported Event|R-ICEesc|R-ICEesc will be administered with the intent of administering 2 cycles, each 21 days apart admixed with 4 doses of rituximab. G-CSF will be administered at 960 ug or 10 ug/kg if patient is > 100 kg after cycles one and two for PBPC collection for the first 10 patients enrolled. G-CSF will be administered in standard dosing for cycle one and then at 960 ug or 10 ug/kg (if patient is > 100 kg) after cycle two for PBPC collection for the remaining 22 patients. All responding patients who make at least 2 x 106 CD34+ cells/kg will receive high dose therapy and ASCT on other protocols.
412330|NCT00587990|B4|Baseline|Total|Total of all reporting groups
412331|NCT00587990|B3|Baseline|(3) Placebo|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
412332|NCT00587990|B2|Baseline|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
412333|NCT00587990|B1|Baseline|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
412334|NCT00587990|P3|Participant Flow|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
412335|NCT00587990|P2|Participant Flow|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
412336|NCT00587990|P1|Participant Flow|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
412337|NCT00587990|O3|Outcome|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
412338|NCT00587990|O2|Outcome|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
412339|NCT00587990|O1|Outcome|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
412394|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
412395|NCT00587769|E1|Reported Event|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
412340|NCT00587990|E3|Reported Event|(3) Placebo Injection|"Participants will receive placebo injections~Placebo: Participants will receive between 10 and 20 placebo injections that consist of phosphate buffered saline (PBS) and 1% human serum albumin (HSA)."
412341|NCT00587990|E2|Reported Event|(2) Higher MSC Dose|"Participants will receive higher dose of mesenchymal stem cell injections for a total of 2 x 108 cells~Higher dose MSC injection: Participants will receive between 10 and 20 intramyocardial injections of 20 million MSCs per 0.25-0.5 cc for a total of 2 x 108 cells. The injections will be administered following completion of CABG surgery."
412342|NCT00587990|E1|Reported Event|(1) Lower MSC Dose|"Participants will receive lower dose mesenchymal stem cell injections for a total of 2 x 107 cells~Lower dose mesenchymal stem cell (MSC) injection: Participants will receive between 10 and 20 intramyocardial injections of 2 million MSCs per 0.25-0.5 cubic centimeter (cc) for a total of 2 x 107 cells. The injections will be administered following completion of CABG surgery."
412343|NCT00587964|B1|Baseline|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
412344|NCT00587964|P1|Participant Flow|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
412345|NCT00587964|O1|Outcome|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
412346|NCT00587964|E1|Reported Event|Treatment - Stereotactic Radiosurgery|Stereotactic Radiosurgery: All patients would undergo craniotomy and the goal of surgery in all cases would be total removal of the metastases.
412347|NCT00587860|B3|Baseline|Total|Total of all reporting groups
412348|NCT00587860|B2|Baseline|Placebo|Placebo, twice a day
412349|NCT00587860|B1|Baseline|St. John's Wort|St. John's Wort, 450 mg twice a day
412350|NCT00587860|P2|Participant Flow|Placebo|Placebo, twice a day
412351|NCT00587860|P1|Participant Flow|St. John's Wort|St. John's Wort, 450 mg twice a day
412352|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412353|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412354|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412355|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412356|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412357|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412358|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412359|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412360|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412361|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412362|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412363|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412364|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412365|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412366|NCT00587860|O2|Outcome|Placebo|Placebo, twice a day
412367|NCT00587860|O1|Outcome|St. John's Wort|St. John's Wort, 450 mg twice a day
412368|NCT00587860|E2|Reported Event|Placebo|Placebo, twice a day
412369|NCT00587860|E1|Reported Event|St. John's Wort|St. John's Wort, 450 mg twice a day
412370|NCT00587847|B1|Baseline|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
412371|NCT00587847|P1|Participant Flow|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
412372|NCT00587847|O1|Outcome|All Participants|All participants were included in the safety analysis.
412373|NCT00587847|O1|Outcome|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
412374|NCT00587847|E1|Reported Event|Single Arm, Open Label Trial.|single arm, open label trial using Campath 30 mg administered subcutaneously at varying intervals for up to 1 year.
412375|NCT00587834|B1|Baseline|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
412376|NCT00587834|P1|Participant Flow|Gintuit and Autologous Free Gingival Graft (FGG)|Single application of Gintuit and FGG (control); split-mouth design
412377|NCT00587834|O2|Outcome|Gintuit Sensitive|Included ratings of Moderate and Severe
412378|NCT00587834|O1|Outcome|Gintuit Not Sensitive|Included ratings of None and Mild
412379|NCT00587834|O1|Outcome|Gintuit|Single application of Gintuit and FGG (control); split-mouth design. Number of subjects preferring Gintuit over Control.
412380|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
412381|NCT00587834|O2|Outcome|Gintuit Not Equally Firm as Adjacent Tissue|"Not Equally Firm includes responses of less firm and more firm"
412382|NCT00587834|O1|Outcome|Gintuit Equally Firm as Adjacent Tissue|
412383|NCT00587834|O2|Outcome|Gintuit Not Equally Red as Adjacent Tissue|"Not Equally Red includes responses of more red and less red"
412384|NCT00587834|O1|Outcome|Gintuit Equally Red as Adjacent Tissue|
412385|NCT00587834|O1|Outcome|Gintuit|Single application;split-mouth design
412386|NCT00587834|E5|Reported Event|Other|Adverse events occurring at any other location in the body or systemic conditions
412387|NCT00587834|E4|Reported Event|Mouth|Adverse events occurring in the mouth and not localized to the Gintuit, FGG, or palatal donation sites.
412388|NCT00587834|E3|Reported Event|Palatal Donation Site|Adverse events occurring at the palatal donation site
412389|NCT00587834|E2|Reported Event|Free Gingival Graft|Adverse events occurring at the autologous free gingival graft site
412390|NCT00587834|E1|Reported Event|Gintuit|Adverse events occurring at the Gintuit treated site
412391|NCT00587769|B1|Baseline|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
412392|NCT00587769|P1|Participant Flow|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
412393|NCT00587769|O1|Outcome|Medication Arm|Varenicline 1.0 mg po bid plus bupropion 150 mg po bid
412397|NCT00587678|B3|Baseline|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412398|NCT00587678|B2|Baseline|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412399|NCT00587678|B1|Baseline|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412400|NCT00587678|P3|Participant Flow|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412401|NCT00587678|P2|Participant Flow|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412402|NCT00587678|P1|Participant Flow|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412403|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412404|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412405|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412406|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412407|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412408|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412409|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412410|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412411|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412412|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412413|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412414|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412415|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412416|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412417|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412418|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412419|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412420|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412421|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412422|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412423|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412424|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412425|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412426|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412427|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412428|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412429|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412430|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412431|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412432|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412433|NCT00587678|O3|Outcome|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412434|NCT00587678|O2|Outcome|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412435|NCT00587678|O1|Outcome|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412436|NCT00587678|E3|Reported Event|Ezetimibe 10mg|Open label Ezetimibe 10mg daily begun after baseline studies for 2 years
412437|NCT00587678|E2|Reported Event|Simvastatin 40mg/Ezetimibe 10 mg|Statin naive patients randomized to simvastatin 40mg/Ezetimibe 10mg qhs after baseline studies for 2 years
412438|NCT00587678|E1|Reported Event|Simvastatin 40mg|Statin naive patients randomized to simvastatin 40mg qhs after baseline studies for 2 years
412439|NCT00587639|B1|Baseline|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
412440|NCT00587639|P1|Participant Flow|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
412441|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
412442|NCT00587639|O1|Outcome|rTMS Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
412443|NCT00587639|E1|Reported Event|Active Treatment|All subjects will have active rTMS treatment (10Hz, L-DLPFC - 3,000 Stimulations/treatment)
412444|NCT00586729|B3|Baseline|Total|Total of all reporting groups
412445|NCT00586729|B2|Baseline|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412446|NCT00586729|B1|Baseline|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412447|NCT00586729|P2|Participant Flow|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412448|NCT00586729|P1|Participant Flow|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412449|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412450|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412451|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412452|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412453|NCT00586729|O2|Outcome|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412454|NCT00586729|O1|Outcome|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412455|NCT00586729|E2|Reported Event|5% Mafenide Acetate|5% Mafenide Acetate applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412456|NCT00586729|E1|Reported Event|Vashe|Vashe Wound Therapy applied to gauze dressing every 6 hours or as necessary to keep dressing moist for a total treatment duration of 5 days.
412457|NCT00586716|B3|Baseline|Total|Total of all reporting groups
412458|NCT00586716|B2|Baseline|IVIG With Living Donor|Intravenous immune globulin for patients who have living donors with positive crossmatch results.
412459|NCT00586716|B1|Baseline|IVIG no Living Donor|Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list
412460|NCT00586716|P2|Participant Flow|Group 2 Intravenous Immune Globulin With Living Donor|"Patients who have living donors with positive crossmatch results.~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
412461|NCT00586716|P1|Participant Flow|Group 1 Intravenous Immune Globulin no Living Donor|"Patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulins : 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
412462|NCT00586716|O2|Outcome|Group 2 Intravenous Immune Globulin|"Intravenous immune globulin for patients who have living donors with positive crossmatch results.~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
412463|NCT00586716|O1|Outcome|Group 1 Intravenous Immune Globulin|"Intravenous immunoglobulin for: patients who do not have a living donor, have a PRA greater than 30% for 3 consecutive months, and have one positive crossmatch with a cadaveric donor while on kidney transplant waiting list~intravenous immune globulin: 0.5-2 gm/kg monthly (maximum dose of 140 gm/dose) x 4 treatments"
412464|NCT00586716|O1|Outcome|Intravenous Immune Globulin|Intravenous immune globulin for patients who have living donors with positive crossmatch results
412465|NCT00586716|E2|Reported Event|Group 2 Intravenous Immune Globulin|Group 2 intravenous immune globulin WITH living donor
412466|NCT00586716|E1|Reported Event|Group 1 Intravenous Immune Globulin|Group 1 with Intravenous immune globulin with no living donor
412467|NCT00587587|B3|Baseline|Total|Total of all reporting groups
412468|NCT00587587|B2|Baseline|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412469|NCT00587587|B1|Baseline|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412470|NCT00587587|P2|Participant Flow|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412471|NCT00587587|P1|Participant Flow|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412472|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412473|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412474|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412475|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412476|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412477|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412478|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412479|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
412480|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412481|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412482|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412483|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412484|NCT00587587|O2|Outcome|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412485|NCT00587587|O1|Outcome|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412486|NCT00587587|O2|Outcome|B (Control)|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412487|NCT00587587|O1|Outcome|A (Apligraf)|Apligraf (bilayered living cell therapy)
412488|NCT00587587|E2|Reported Event|Control|Dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412489|NCT00587587|E1|Reported Event|Apligraf|Apligraf (bilayered living cellular construct) plus a dressing regimen comprised of a primary nonadherent dressing, dry gauze dressing and bolster gauze dressing, if necessary
412490|NCT00587483|B4|Baseline|Total|Total of all reporting groups
412491|NCT00587483|B3|Baseline|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412492|NCT00587483|B2|Baseline|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412493|NCT00587483|B1|Baseline|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412494|NCT00587483|P3|Participant Flow|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412495|NCT00587483|P2|Participant Flow|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412496|NCT00587483|P1|Participant Flow|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412497|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412498|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412499|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412500|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412501|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412502|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412503|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412504|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412505|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412506|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412507|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412508|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412509|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412510|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412511|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412512|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412513|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412514|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412515|NCT00587483|O3|Outcome|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412516|NCT00587483|O2|Outcome|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412517|NCT00587483|O1|Outcome|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412518|NCT00587483|E3|Reported Event|Placebo (Saline)|Subjects randomized to receive placebo (saline) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
416670|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
412519|NCT00587483|E2|Reported Event|Amiodarone 300 mg|Subjects randomized to receive Amiodarone 300 mg IV(followed by 150 mg IV if needed) via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412520|NCT00587483|E1|Reported Event|Lidocaine 1.5 mg /kg|Subjects randomized to receive Lidocaine 1.5 mg/kg via the cardiopulmonary reservoir prior to the removal of the aortic cross clamp.
412521|NCT00587431|B3|Baseline|Total|Total of all reporting groups
412522|NCT00587431|B2|Baseline|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
412523|NCT00587431|B1|Baseline|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
412524|NCT00587431|P2|Participant Flow|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
412525|NCT00587431|P1|Participant Flow|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
412526|NCT00587431|O1|Outcome|All Participants|All participants
412527|NCT00587431|O4|Outcome|Lupron + Docetaxel (70 mg/m2) + Testosterone (Metastatic)|"(Metastatic) GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
412528|NCT00587431|O3|Outcome|Lupron +Docetaxel (70 mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
412529|NCT00587431|O2|Outcome|Lupron + Docetaxel (75mg/m2) + Testosterone for (Metastatic)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
412530|NCT00587431|O1|Outcome|Lupron + Docetaxel (75mg/m2) +Testosterone (RISING PSA)|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
412531|NCT00587431|E2|Reported Event|Lupron and Docetaxel (70 mg/m2) and Testosterone for 3 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 70 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 3 days"
412532|NCT00587431|E1|Reported Event|Lupron and Docetaxel (75mg/m2) and Testosterone for 7 Days|"GnRh (Leuprolide): Leuprolide LUPRON~Docetaxel: 75 mg/m2 given on day 1 of each 3 week cycle~Testosterone Gel: Starting during week 3 (day 19) of cycle 1, 7.5G applied topically daily for 7 days"
412533|NCT00587288|B3|Baseline|Total|Total of all reporting groups
412534|NCT00587288|B2|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412535|NCT00587288|B1|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412536|NCT00587288|P2|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412537|NCT00587288|P1|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412538|NCT00587288|O2|Outcome|Placebo|Saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412539|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|Reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412540|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412541|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412542|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412543|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412544|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412545|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412546|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412547|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412548|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412549|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412550|NCT00587288|O2|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412551|NCT00587288|O1|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg intravenous (IV) on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412552|NCT00587288|E2|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412553|NCT00587288|E1|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/- 7 days) cycle, for 4 cycles
412554|NCT00587223|B1|Baseline|Apligraf/Control|Apligraf (a living bilayered cell therapy product) Control (a primary nonadherent dressing, nonstick gauze, retainer dressing)
412555|NCT00587223|P1|Participant Flow|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412556|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
412557|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
416671|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
412558|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
412559|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412560|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
412561|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412562|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. Control lesions are treated with standard wound dressings.
412563|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412564|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesions receive standard wound dressings.
412565|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412566|NCT00587223|O2|Outcome|Control|Within subject control: 2 lesions per subject randomized to receive Apligraf or Control treatment. Control treated lesion receives standard wound dressings.
412567|NCT00587223|O1|Outcome|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412568|NCT00587223|E1|Reported Event|Apligraf|Within subject control: 2 lesions per subjects randomized to receive Apligraf or Control treatment. The lesion treated with Apligraf receives a single topical application of Apligraf to cover the lesion.
412569|NCT00587171|B3|Baseline|Total|Total of all reporting groups
412570|NCT00587171|B2|Baseline|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412571|NCT00587171|B1|Baseline|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412572|NCT00587171|P2|Participant Flow|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412573|NCT00587171|P1|Participant Flow|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412574|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412575|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412576|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412577|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412578|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412579|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412580|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412581|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412582|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412583|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412584|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412585|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412586|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412587|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412588|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412589|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412590|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412754|NCT00586625|O2|Outcome|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
412591|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412592|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412593|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412594|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412595|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412596|NCT00587171|O2|Outcome|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412597|NCT00587171|O1|Outcome|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412598|NCT00587171|E2|Reported Event|Control|2 hours of daily patching combined with 1 hour of daily near activities (that includes 30 minutes of at-home control vision therapy) and weekly in-office control vision therapy
412599|NCT00587171|E1|Reported Event|Active|2 hours of daily patching combined with 1 hour daily of near activities (that includes 30 minutes of at-home active vision therapy) and weekly in-office active vision therapy
412600|NCT00587158|B3|Baseline|Total|Total of all reporting groups
412601|NCT00587158|B2|Baseline|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412602|NCT00587158|B1|Baseline|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412603|NCT00587158|P2|Participant Flow|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive therapy consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®). In addition, subjects in this group will receive the study medication paricalcitol (Zemplar®).
412604|NCT00587158|P1|Participant Flow|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies consisting of induction therapy with Alemtuzumab (Campath®) and Methylprednisolone (Solumedrol®), then maintained with corticosteroid avoidance using Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412605|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412606|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412607|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412608|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412609|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412610|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412611|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412612|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412613|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412614|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412615|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412616|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412670|NCT00586846|B1|Baseline|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
412671|NCT00586846|P1|Participant Flow|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
412617|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412618|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412619|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412620|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412621|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412622|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412623|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412624|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412625|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412626|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412627|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412628|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412629|NCT00587158|O2|Outcome|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412630|NCT00587158|O1|Outcome|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412631|NCT00587158|E2|Reported Event|Immunosuppression With Paricalcitol|Subjects will receive the standard immunosuppressive medications; Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®),Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®), and in addition will receive the study medication paricalcitol (Zemplar®).
412632|NCT00587158|E1|Reported Event|Immunosuppression Without Paricalcitol (Control)|Subjects will receive the standard immunosuppressive therapies of Alemtuzumab (Campath®), Methylprednisolone (Solumedrol®), Mycophenolate Mofetil (Cellcept®) and Tacrolimus (Prograf®).
412633|NCT00587132|B5|Baseline|Total|Total of all reporting groups
412634|NCT00587132|B4|Baseline|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
412635|NCT00587132|B3|Baseline|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412636|NCT00587132|B2|Baseline|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412637|NCT00587132|B1|Baseline|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412638|NCT00587132|P4|Participant Flow|Clinical Symptoms of Pancreatic Cancer, Normal CT|Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
412639|NCT00587132|P3|Participant Flow|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412640|NCT00587132|P2|Participant Flow|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412672|NCT00586846|O1|Outcome|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
412673|NCT00586846|E1|Reported Event|All Patients|Chemotherapy and Pamidronate for the Treatment of Newly Diagnosed Osteosarcoma
412674|NCT00586820|B3|Baseline|Total|Total of all reporting groups
412641|NCT00587132|P1|Participant Flow|New Onset Diabetes|"Adults diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412642|NCT00587132|O4|Outcome|Clinical Symptoms of Pancreatic Cancer, Normal CT|"Adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412643|NCT00587132|O3|Outcome|Peutz-Jeghers Syndrome|"Adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412644|NCT00587132|O2|Outcome|Familial Pancreatic Cancer|"Adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412645|NCT00587132|O1|Outcome|New Onset Diabetes|"Adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412646|NCT00587132|E4|Reported Event|Clinical Symptoms of Pancreatic Cancer, Normal CT|10 adults age 35-99 with suspicious clinical symptoms of pancreatic cancer, but had normal CT of the abdomen with iodinated contrast within 2 weeks.
412647|NCT00587132|E3|Reported Event|Peutz-Jeghers Syndrome|"10 adults age 35-99 with Peutz-Jeghers syndrome.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412648|NCT00587132|E2|Reported Event|Familial Pancreatic Cancer|"10 adults age 35-99 with familial pancreatic cancer with two or more first degree relatives with pancreatic cancer~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412649|NCT00587132|E1|Reported Event|New Onset Diabetes|"10 adults, diagnosed diabetes within two years, and at least one of the following: no family history of diabetes, abdominal discomfort, anorexia, weight loss, elevated serum cancer antigen 19-9 (CA 19-9), or those undergoing endoscopic ultrasound (EUS) with or without Fine Needle Aspiration (FNA) for pancreatic cancer screening.~All subjects on this arm will receive Synthetic Human Secretin as a 0.2mcg/kg one time dose prior to CT imaging on Day 1 of the study."
412650|NCT00587041|B4|Baseline|Total|Total of all reporting groups
412651|NCT00587041|B3|Baseline|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
412652|NCT00587041|B2|Baseline|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
412653|NCT00587041|B1|Baseline|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
412654|NCT00587041|P3|Participant Flow|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
412655|NCT00587041|P2|Participant Flow|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
412656|NCT00587041|P1|Participant Flow|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
412657|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
412658|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
412659|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
412660|NCT00587041|O3|Outcome|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
412661|NCT00587041|O2|Outcome|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
412662|NCT00587041|O1|Outcome|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
412663|NCT00587041|E3|Reported Event|Placebo|Participants received placebo for 6 weeks: 1 placebo packet daily and 1 placebo capsule twice daily
412664|NCT00587041|E2|Reported Event|Oxadrop|Participants received Oxadrop for 6 weeks: Oxadrop 1 packet daily plus 1 placebo capsule twice daily. Each gram of Oxadrop® contains 2x1011 bacteria (L. acidophilus, L. brevis, S. thermophilus, and B. infantis)
412665|NCT00587041|E1|Reported Event|Agri-King Synbiotic|Participants received AKSB for 6 weeks: AKSB 1 capsule twice daily plus 1 placebo packet daily. AKSB contains Fructo-oligosaccharide; Enterococcus faecium (SF68); Saccharomyces cerevisiae subspecies Boulardi; and Saccharomyces cerevisiae
412666|NCT00586898|B1|Baseline|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
412667|NCT00586898|P1|Participant Flow|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
412668|NCT00586898|O1|Outcome|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
412669|NCT00586898|E1|Reported Event|All Participants|Rapid Hormonal Cycling as Treatment for Patients with Prostate Cancer
412675|NCT00586820|B2|Baseline|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
412676|NCT00586820|B1|Baseline|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
412677|NCT00586820|P2|Participant Flow|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
412678|NCT00586820|P1|Participant Flow|BQ-123|The selective endothelin type A receptor antagonist (BQ-123) will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
412679|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
412680|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
412681|NCT00586820|O2|Outcome|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion (saline) for 20 minutes prior to PCI.
412682|NCT00586820|O1|Outcome|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
412683|NCT00586820|E2|Reported Event|Placebo|Subjects randomized to the placebo arm will receive a placebo infusion for 20 minutes prior to PCI.
412684|NCT00586820|E1|Reported Event|BQ-123|BQ-123 will be infused at 300 nmol/min for 20 minutes prior to percutaneous coronary intervention (PCI).
412685|NCT00586703|B1|Baseline|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
412686|NCT00586703|P1|Participant Flow|Experimental: NK-CD56|"NK Cell infusion using CD56 monoclonal antibody following nonmyeloablative SCT from mismatched donors~NK Cell Infusion following SCT from mismatched donors : The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II aGVHD at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
412687|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
412688|NCT00586703|O1|Outcome|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
412689|NCT00586703|E1|Reported Event|Experimental: NK-CD56|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody following nonmyeloablative stem cell transplant (SCT) from mismatched donors~NK Cell Infusion following SCT from mismatched donors: The cells from leukapheresis will be NK selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft-versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion."
412690|NCT00586690|B3|Baseline|Total|Total of all reporting groups
412691|NCT00586690|B2|Baseline|Donor Apheresis|Apheresis repeated daily up to 3 days until target dose of cells reached (preferably without donor receiving growth factors). Cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These extra cell collections from the donor were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
412692|NCT00586690|B1|Baseline|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
412715|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412716|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412829|NCT00586573|O1|Outcome|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
412693|NCT00586690|P2|Participant Flow|Donor Apheresis|Leukapheresis was repeated daily up to 3 days until the target dose of cells was reached (preferably without donor receiving growth factors). When possible, cells were transfused immediately after collection and processing. If collections occurred during initial mobilization at the time of stem cell transplant, the donor was off growth factor for >24 hours. These collections, which are extra cells collected from the donor following initial collections for transplant were sufficient for the natural killer cells used in the trial. The cells were NK selected using a CD56 antibody (CliniMACS CD56 Reagent), CliniMACSplus instrument and CliniMACS tubing set provided by Miltenyi Biotec using the company protocol (Miltenyi Biotec Inc, Auburn, California). Pre and post processing cell count, viability, Hematopoietic Progenitor Cell Assay (HPCA) and flow analysis were done.
412694|NCT00586690|P1|Participant Flow|NK Cell Infusion|NK Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion. Patients will be evaluated for toxicity and response until 20 weeks after the last NK Infusion.
412695|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
412696|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
412697|NCT00586690|O1|Outcome|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
412698|NCT00586690|O1|Outcome|NK Cell Infusion|"Natural Killer (NK) Cell infusion using CD56 monoclonal antibody:~The cells from leukapheresis will be NK cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion."
412699|NCT00586690|E1|Reported Event|NK Cell Infusion|Natural Killer (NK) Cell infusion using CD56 monoclonal antibody: The cells from leukapheresis will be natural killer (NK) cell selected using a CD56 antibody and a cell column system provided by Miltenyi Biotec. The target cell dose for each NK cell infusion will be up to 1 X 10(7) CD56+ cells/kg patient weight with less than 0.5 X 10(6) CD3+ cells/kg patient weight. The first NK cell infusion will be administered 6 weeks post transplant in patients who have ≤ grade II acute graft versus host disease (aGVHD) at the time of infusion.
412700|NCT00586664|B4|Baseline|Total|Total of all reporting groups
412701|NCT00586664|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412702|NCT00586664|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412703|NCT00586664|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412704|NCT00586664|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412705|NCT00586664|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412706|NCT00586664|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412707|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412708|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412709|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412710|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412711|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412712|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412713|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412714|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412717|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412718|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412719|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412720|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412721|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412722|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412723|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412724|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412725|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412726|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412727|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412728|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412729|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412730|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412731|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412732|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412733|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412734|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412735|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412736|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412737|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412738|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412739|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412740|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412741|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412742|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412743|NCT00586664|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412744|NCT00586664|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412745|NCT00586664|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412746|NCT00586664|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412747|NCT00586664|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412748|NCT00586664|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
412749|NCT00586625|B3|Baseline|Total|Total of all reporting groups
412750|NCT00586625|B2|Baseline|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
412751|NCT00586625|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
412752|NCT00586625|P2|Participant Flow|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
412753|NCT00586625|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
412755|NCT00586625|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
412756|NCT00586625|E2|Reported Event|Placebo (Vehicle)|One drop, both eyes, twice a day for six weeks
412757|NCT00586625|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|One drop, both eyes, twice a day for six weeks
412758|NCT00586612|B3|Baseline|Total|Total of all reporting groups
412759|NCT00586612|B2|Baseline|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412760|NCT00586612|B1|Baseline|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412761|NCT00586612|P2|Participant Flow|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412762|NCT00586612|P1|Participant Flow|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412763|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412764|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412765|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412766|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412767|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412768|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412769|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412770|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412771|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412772|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412773|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412774|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412775|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412776|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412777|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412778|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412779|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412780|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412781|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412782|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412783|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412784|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412785|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412786|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412787|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412788|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412789|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412790|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412791|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412792|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412793|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412794|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412795|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412796|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412797|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412798|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412799|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412800|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412801|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412802|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412803|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412830|NCT00586573|E1|Reported Event|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
412876|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412804|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412805|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412806|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412807|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412808|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412809|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412810|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412811|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412812|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412813|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412814|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412815|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412816|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412817|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412818|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412819|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412820|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412821|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412822|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412823|NCT00586612|O2|Outcome|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412824|NCT00586612|O1|Outcome|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412825|NCT00586612|E2|Reported Event|Full-term Group|Subjects born after a gestation period of more than 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412826|NCT00586612|E1|Reported Event|Preterm Group|Subjects born after a gestation period of less than or equal to 36 weeks and who received 3 doses (at 2, 4 and 6 months of age) of Menitorix™, Infanrix™ penta and Prevenar™ and a booster dose of Menitorix™, Infanrix™ IPV and Prevenar™ at 16-18 months of age.
412827|NCT00586573|B1|Baseline|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
412828|NCT00586573|P1|Participant Flow|Memantine|5-20 mg, twice daily, by mouth, 12 weeks
412831|NCT00586521|B1|Baseline|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412832|NCT00586521|P1|Participant Flow|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412833|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412834|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412835|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412836|NCT00586521|O1|Outcome|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412837|NCT00586521|E1|Reported Event|rFVIII-FS (Octocog-alfa), (Kogenate FS)|On-demand treatment was to follow the same treatment pattern the subject was using before entering the study. While on prophylactic treatment, all subjects were to be treated at a dose of 20-40 IU/kg, 3 times per week at a stable dose.
412838|NCT00586495|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412839|NCT00586495|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412840|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412841|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412842|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412843|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412844|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412845|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412846|NCT00586495|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412847|NCT00586495|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 200 mg tablets (400 mg [2 x 200 mg tablets] twice daily [bid] or 400 mg once daily [od] or 400 mg every other day [qod]) administered orally
412848|NCT00586482|B3|Baseline|Total|Total of all reporting groups
412849|NCT00586482|B2|Baseline|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412850|NCT00586482|B1|Baseline|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412851|NCT00586482|P2|Participant Flow|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412852|NCT00586482|P1|Participant Flow|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412853|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412875|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
416672|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
412854|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412855|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412856|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412857|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412858|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412859|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412860|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412861|NCT00586482|O2|Outcome|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412862|NCT00586482|O1|Outcome|Nicotine Lozenges|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412863|NCT00586482|E2|Reported Event|Placebo Lozenge|"Placebo lozenges, matching in appearance the 2 and 4 mg active nicotine lozenges, taken by mouth without restriction from 7 pm the night before surgery to the time of surgical admission the next day.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412864|NCT00586482|E1|Reported Event|Nicotine Lozenge|"Nicotine lozenges, 2 or 4 mg, taken without restriction by mouth from 7 pm the evening before surgery until surgical admission the next day. Dosed according to time to first morning cigarette; if within 30 minutes of awakening, 4 mg lozenge used. If first cigarette smoked greater than 30 minutes of awakening, 2 mg lozenge used.~Subjects also received an abstinence advisement: a brief (approximately 2 minute) behavioral intervention advising abstinence from smoking after 7 pm the night before surgery, the potential benefits of abstinence and to use a lozenge at usual smoking times."
412865|NCT00586469|B3|Baseline|Total|Total of all reporting groups
412866|NCT00586469|B2|Baseline|New Bulk|This group received a full dose of Fluviral made from new material
412867|NCT00586469|B1|Baseline|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412868|NCT00586469|P2|Participant Flow|New Bulk|This group received a full dose of Fluviral made from new material
412869|NCT00586469|P1|Participant Flow|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412870|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412871|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412872|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412873|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412874|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
416673|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
412877|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412878|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412879|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412880|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412881|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412882|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412883|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412884|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412885|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412886|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412887|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412888|NCT00586469|O2|Outcome|New Bulk|This group received a full dose of Fluviral made from new material
412889|NCT00586469|O1|Outcome|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412890|NCT00586469|E2|Reported Event|New Bulk|This group received a full dose of Fluviral made from new material
412891|NCT00586469|E1|Reported Event|Old Bulk|This group received a full dose of Fluviral made from aged bulk material
412892|NCT00586339|B4|Baseline|Total|Total of all reporting groups
412893|NCT00586339|B3|Baseline|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412894|NCT00586339|B2|Baseline|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412895|NCT00586339|B1|Baseline|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412896|NCT00586339|P3|Participant Flow|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412897|NCT00586339|P2|Participant Flow|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412898|NCT00586339|P1|Participant Flow|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412899|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412900|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412901|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412902|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412903|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412904|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412905|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412906|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412907|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412996|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
412997|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
412908|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412909|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412910|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412911|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412912|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412913|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412914|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412915|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412916|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412917|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412918|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412919|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412920|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412921|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412922|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412923|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412924|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412925|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412926|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412927|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412928|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412998|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
412929|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412930|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412931|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412932|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412933|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412934|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412935|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412936|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412937|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412938|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412939|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412940|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412941|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412942|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412943|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412944|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412945|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412946|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412947|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412948|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412949|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412999|NCT00586326|E1|Reported Event|Intent to Treat|Enrolled subjects with MammoSite device placed
416674|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
412950|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412951|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412952|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412953|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412954|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412955|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412956|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412957|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412958|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412959|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412960|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412961|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412962|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412963|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412964|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412965|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412966|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412967|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412968|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412969|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412970|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
413220|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
412971|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412972|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412973|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412974|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412975|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412976|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412977|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412978|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412979|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412980|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412981|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412982|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412983|NCT00586339|O3|Outcome|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412984|NCT00586339|O2|Outcome|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412985|NCT00586339|O1|Outcome|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412986|NCT00586339|E3|Reported Event|HIV-/Cervarix Group|Human immunodeficiency virus negative (HIV-) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412987|NCT00586339|E2|Reported Event|HIV+/Aluminium Hydroxide Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of control Aluminium Hydroxide [Al(OH)3] vaccine at Day 0, Month 1 and Month 6. Aluminium Hydroxide vaccine was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412988|NCT00586339|E1|Reported Event|HIV+/Cervarix Group|Human immunodeficiency virus positive (HIV+) subjects received 3 doses of Cervarix™ vaccine at Day 0, Month 1 and Month 6. Cervarix™ vaccines was administrated by intramuscular injection into the deltoid region of the non-dominant arm according to a 0, 1, 6 month schedule.
412989|NCT00586326|B1|Baseline|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
412990|NCT00586326|P1|Participant Flow|Enrolled|Women with DCIS who were willing to enroll and consented
412991|NCT00586326|O4|Outcome|Poor|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Poor' at 5 years
412992|NCT00586326|O3|Outcome|Fair|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Fair' at 5 years
412993|NCT00586326|O2|Outcome|Good|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Good' at 5 years
412994|NCT00586326|O1|Outcome|Excellent|Subjects enrolled with device placed and treated with partial breast irradiation who had the cosmetic evaluation scored as 'Excellent' at 5 years
412995|NCT00586326|O1|Outcome|Treated|Subjects enrolled with device placed and treated with partial breast irradiation
413000|NCT00586313|B1|Baseline|Participants Undergoing the Tru-Cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
413001|NCT00586313|P1|Participant Flow|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
413002|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
413003|NCT00586313|O1|Outcome|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
413004|NCT00586313|E1|Reported Event|EUS Tru-cut Biopsy|"Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples.~EUS Tru-cut biopsy: Transgastric EUS-TCB may prove to be a safe alternative to percutaneous and transjugular liver biopsy methods in obtaining liver biopsy samples. This technique may be particularly helpful to obtain liver biopsies in patients with morbid obesity or patients in whom there is no obtainable view to obtain a percutaneous biopsy."
413005|NCT00586261|B3|Baseline|Total|Total of all reporting groups
413006|NCT00586261|B2|Baseline|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
413007|NCT00586261|B1|Baseline|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
413008|NCT00586261|P2|Participant Flow|Placebo|Placebo 30 mg daily for 6 months
413009|NCT00586261|P1|Participant Flow|Pioglitazone|Pioglitazone 30 mg daily for 6 months
413010|NCT00586261|O2|Outcome|Placebo Arm|"study the specific dose of placebo 30 mg daily for 6 months~placebo : placebo 30 mg daily for 6 months"
413011|NCT00586261|O1|Outcome|Pioglitazone Arm|"study the specific dose of pioglitazone 30 mg daily for 6 months~pioglitazone : pioglitazone 30 mg daily for 6 months"
413012|NCT00586261|E2|Reported Event|Placebo|Placebo 30 mg daily for six months
413013|NCT00586261|E1|Reported Event|Pioglitazone|Pioglitazone 30 mg daily for six months
413014|NCT00586196|B3|Baseline|Total|Total of all reporting groups
413015|NCT00586196|B2|Baseline|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
413016|NCT00586196|B1|Baseline|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
413017|NCT00586196|P2|Participant Flow|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
413018|NCT00586196|P1|Participant Flow|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
413019|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
413020|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
413021|NCT00586196|O2|Outcome|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
413022|NCT00586196|O1|Outcome|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
413023|NCT00586196|E2|Reported Event|Placebo : Encapsulated Cornstarch|Placebo : Encapsulated cornstarch One capsule daily for 30 days
413024|NCT00586196|E1|Reported Event|Donepezil : 5 mg Each Day for 30 Days|donepezil : 5 mg each day for 30 days
413025|NCT00586170|B3|Baseline|Total|Total of all reporting groups
413026|NCT00586170|B2|Baseline|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413027|NCT00586170|B1|Baseline|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413028|NCT00586170|P2|Participant Flow|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413029|NCT00586170|P1|Participant Flow|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413030|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413031|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413113|NCT00585650|P1|Participant Flow|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
413032|NCT00586170|O2|Outcome|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413033|NCT00586170|O1|Outcome|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413034|NCT00586170|E2|Reported Event|Placebo Device + Surgery|"Subject will be using a placebo device in conjunction with ORIF surgery of the nonunion site.~Placebo Device: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413035|NCT00586170|E1|Reported Event|EBI Bone Healing System + Surgery|"Subject will be using the EBI Bone Healing System (active device) in conjunction with ORIF surgery of the nonunion site.~EBI Bone Healing System: 10 hours of treatment per day for up to 24 weeks~Surgery: Open Reduction and Internal Fixation of the nonunion site"
413036|NCT00586157|B1|Baseline|Entire Study Population|
413037|NCT00586157|P2|Participant Flow|Placebo Then MTS|Placebo in first intervention then MTS in second intervention
413038|NCT00586157|P1|Participant Flow|MTS Then Placebo|MTS in first intervention then Placebo in second intervention
413039|NCT00586157|O2|Outcome|Placebo|
413040|NCT00586157|O1|Outcome|MTS (Drug A)|
413041|NCT00586157|O2|Outcome|Placebo|
413042|NCT00586157|O1|Outcome|MTS (Drug A)|
413043|NCT00586157|O2|Outcome|Placebo|
413044|NCT00586157|O1|Outcome|MTS (Drug A)|
413045|NCT00586157|E2|Reported Event|Placebo|
413046|NCT00586157|E1|Reported Event|MTS (Drug A)|
413047|NCT00586105|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413048|NCT00586105|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413049|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413050|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413051|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413052|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413053|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413054|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413055|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413056|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413057|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413058|NCT00586105|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413059|NCT00586105|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|400 mg (2 tablets of 200 mg) of sorafenib per oral (PO) twice daily (BID)
413060|NCT00585975|B3|Baseline|Total|Total of all reporting groups
413061|NCT00585975|B2|Baseline|Xibrom 0.09%|
413062|NCT00585975|B1|Baseline|Bromfenac Ophthalmic Solution 0.18%|
413063|NCT00585975|P2|Participant Flow|Xibrom 0.09%|
413064|NCT00585975|P1|Participant Flow|Bromfenac Ophthalmic Solution 0.18%|
413065|NCT00585975|O2|Outcome|Xibrom 0.09%|
413066|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
413067|NCT00585975|O2|Outcome|Xibrom 0.09%|
413068|NCT00585975|O1|Outcome|Bromfenac Ophthalmic Solution 0.18%|
413069|NCT00585975|E2|Reported Event|Xibrom 0.09%|
413070|NCT00585975|E1|Reported Event|Bromfenac Ophthalmic Solution 0.18%|
413071|NCT00585923|B3|Baseline|Total|Total of all reporting groups
413072|NCT00585923|B2|Baseline|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413073|NCT00585923|B1|Baseline|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413074|NCT00585923|P2|Participant Flow|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413075|NCT00585923|P1|Participant Flow|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413076|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413077|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413078|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413079|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413080|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413081|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413082|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413083|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413084|NCT00585923|O2|Outcome|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413085|NCT00585923|O1|Outcome|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413086|NCT00585923|E2|Reported Event|Slotted Hole C-Tek Plate|Slotted Hole C-Tek Plate for ACDF
413087|NCT00585923|E1|Reported Event|Fixed Hole C-Tek Plate|Fixed Hole C-Tek Plate for Anterior Cervical Discectomy & Fusion (ACDF)
413112|NCT00585650|P2|Participant Flow|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
413088|NCT00585910|B1|Baseline|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
413089|NCT00585910|P1|Participant Flow|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
413090|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
413091|NCT00585910|O1|Outcome|Overall Study|Atomoxetine (ATMX) treatment will be initiated and maintained for 4 weeks. If the subject is a partial responder to atomoxetine treatment, OROS methylphenidate (OROS MPH) will then be added to his or her treatment regimen for the final 3 weeks of the study. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
413092|NCT00585910|E2|Reported Event|ATMX and OROS MPH|Partial responders to ATMX alone entered into the ATMX and OROS MPH phase. Subjects already on ATMX before entering the study can enter directly into the OROS MPH phase of the study. 15 out of 55 completed Phase I only and 10 entered directly into Phase II.
413093|NCT00585910|E1|Reported Event|ATMX Only|Atomoxetine treatment will be initiated and maintained for 4 weeks. If the subject is not a partial responder to ATMX, they will end their study participation before entering into the ATMX + OROS MPH phase.
413094|NCT00585715|B3|Baseline|Total|Total of all reporting groups
413095|NCT00585715|B2|Baseline|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413096|NCT00585715|B1|Baseline|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413097|NCT00585715|P2|Participant Flow|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413098|NCT00585715|P1|Participant Flow|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413099|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413100|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413101|NCT00585715|O2|Outcome|Laser Without Cooling for Skin Tightening|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413102|NCT00585715|O1|Outcome|Laser With Cooling for Skin Tightening|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413103|NCT00585715|E2|Reported Event|Laser Without Cooling|Laser used without Candela DCD cooling. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413104|NCT00585715|E1|Reported Event|Laser With Cooling|Laser used with Candela DCD cooling which produces spray of cryogenic fluid that cools the epidermis prior to each laser pulse. Pulse duration 20-50ms using wavelength 1064nm. Laser treatments repeated every 3 weeks for a total of 3 treatments.
413105|NCT00585689|B1|Baseline|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
413106|NCT00585689|P1|Participant Flow|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
413107|NCT00585689|O1|Outcome|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
413108|NCT00585689|E1|Reported Event|Neoadjuvant ABI-007, Carboplatin, and Gemcitabine|Neoadjuvant ABI-007 (260 mg/m^2) on day 1, Carboplatin (Target AUC [Area under the curve] =5) on day 1, and Gemcitabine (800 mg^m2) on days 1 and 8, every 21 days.
413109|NCT00585650|B3|Baseline|Total|Total of all reporting groups
413110|NCT00585650|B2|Baseline|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
413111|NCT00585650|B1|Baseline|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
413114|NCT00585650|O2|Outcome|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
413115|NCT00585650|O1|Outcome|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
413116|NCT00585650|E2|Reported Event|Subjects Receiving Placebo for the First 12 Weeks|Subjects randomized placebo injection for first 12 weeks. All subjects receiving placebo were then crossed over to etanercept 50mg twice weekly for another 12 weeks. An additional follow-up visit was performed on week 28.
413117|NCT00585650|E1|Reported Event|Subjects Receiving Etanercept 50 mg Twice Week for 12 Weeks|Subjects randomized to use etanercept 50mg twice weekly for 12 weeks. An additional follow-up visit was performed on week 28.
413118|NCT00585637|B5|Baseline|Total|Total of all reporting groups
413119|NCT00585637|B4|Baseline|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413120|NCT00585637|B3|Baseline|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413121|NCT00585637|B2|Baseline|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413122|NCT00585637|B1|Baseline|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413123|NCT00585637|P4|Participant Flow|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413124|NCT00585637|P3|Participant Flow|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413125|NCT00585637|P2|Participant Flow|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413126|NCT00585637|P1|Participant Flow|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413127|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413128|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413129|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413130|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413131|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413132|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413133|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413134|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413135|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413136|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413137|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413138|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413139|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413140|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413141|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413142|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413143|NCT00585637|O4|Outcome|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413144|NCT00585637|O3|Outcome|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413145|NCT00585637|O2|Outcome|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413146|NCT00585637|O1|Outcome|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413147|NCT00585637|E4|Reported Event|4000 IU of Vitamin D|"4000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413148|NCT00585637|E3|Reported Event|2000 IU of Vitamin D|"2000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413149|NCT00585637|E2|Reported Event|1000 IU of Vitamin D|"1000 IU of Vitamin D~Vitamin D: Taken orally every day for three months"
413150|NCT00585637|E1|Reported Event|No Vitamin D|"No Vitamin D~Placebo: Placebo pill taken once daily for 3 month"
413151|NCT00585533|B1|Baseline|All Participants|All participants enrolled in trial.
413152|NCT00585533|P1|Participant Flow|All Participants|All participants enrolled in trial.
413153|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
413154|NCT00585533|O1|Outcome|All Participants|All participants enrolled in trial.
413155|NCT00585533|E1|Reported Event|All Participants|All participants enrolled in trial.
413156|NCT00585494|B1|Baseline|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
413157|NCT00585494|P1|Participant Flow|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
413158|NCT00585494|O1|Outcome|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
413159|NCT00585494|E1|Reported Event|Preoperative Orthopedic|Patients undergoing elective total hip, knee and spinal surgery at UW hospital, having their preoperative visit between December 1, 2007 and November 30, 2008.
413160|NCT00585468|B1|Baseline|Entire Study Population|Includes groups randomized to the Fed State first and to the Fasted State first
413161|NCT00585468|P2|Participant Flow|Fasting State First, Then Fed State|720 mg mycophenolate sodium orally twice daily separated from food by 2 hours for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily with a meal in the second intervention period.
413162|NCT00585468|P1|Participant Flow|Fed State First, Then Fasting State|720 milligrams (mg) mycophenolate sodium orally twice daily with a meal for one week in the first intervention period, followed by one week of 720 mg mycophenolate sodium orally twice daily separated by food by 2 hours in the second intervention period.
413163|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413164|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413165|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413166|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413167|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413168|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413169|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413170|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413171|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413172|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413173|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413174|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413175|NCT00585468|O2|Outcome|Myfortic - Fasting State|"Mycophenolate sodium taken separately from food by 2 hours.~Myfortic: Myfortic 720 mg orally twice daily"
413176|NCT00585468|O1|Outcome|Myfortic - Fed State|"Mycophenolate sodium taken with a meal.~Myfortic: Myfortic 720 mg orally twice daily"
413177|NCT00585468|O2|Outcome|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
413178|NCT00585468|O1|Outcome|Myfortic - Fed State|Mycophenolate sodium taken with a meal
413179|NCT00585468|E2|Reported Event|Myfortic - Fasting State|Mycophenolate sodium taken separately from food by 2 hours
413180|NCT00585468|E1|Reported Event|Myfortic - Fed State|Mycophenolate sodium taken with a meal
413181|NCT00585377|B1|Baseline|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413182|NCT00585377|P1|Participant Flow|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413183|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413184|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413185|NCT00585377|O1|Outcome|Arm 1:Bevacizumab and Erlotinib|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413186|NCT00585377|E1|Reported Event|Arm 1|Bevacizumab and Erlotinib: Erlotinib 150 mg/day orally plus bevacizumab 15 mg/kg intravenously every 21 days
413187|NCT00585351|B7|Baseline|Total|Total of all reporting groups
413188|NCT00585351|B6|Baseline|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413189|NCT00585351|B5|Baseline|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413190|NCT00585351|B4|Baseline|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413191|NCT00585351|B3|Baseline|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413192|NCT00585351|B2|Baseline|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413193|NCT00585351|B1|Baseline|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413194|NCT00585351|P8|Participant Flow|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413195|NCT00585351|P7|Participant Flow|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413219|NCT00585312|O2|Outcome|Placebo|Matching placebo
413196|NCT00585351|P6|Participant Flow|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413197|NCT00585351|P5|Participant Flow|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413198|NCT00585351|P4|Participant Flow|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until the Air Care helicopter crew has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413199|NCT00585351|P3|Participant Flow|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of the Air Care helicopter crew to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413200|NCT00585351|P2|Participant Flow|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
413201|NCT00585351|P1|Participant Flow|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
413202|NCT00585351|O4|Outcome|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413203|NCT00585351|O3|Outcome|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413204|NCT00585351|O2|Outcome|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413205|NCT00585351|O1|Outcome|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413206|NCT00585351|O2|Outcome|No Advanced Notification|Subjects in this group are randomized to not receiving any advanced notification about the study, so they are not provided the informed consent document until Air Care helicopter crew has arrived to the outside hospital where the subject is at.
413207|NCT00585351|O1|Outcome|Advanced Notification|Subjects in this group are randomized to receiving advanced notification about the AIRDOC study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care helicopter crew to the outside hospital where the subject is at.
413208|NCT00585351|E6|Reported Event|No Advanced Notification + Placebo|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413209|NCT00585351|E5|Reported Event|Advanced Notification + Placebo|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving placebo.
413210|NCT00585351|E4|Reported Event|No Advanced Notification + Ranitidine|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413211|NCT00585351|E3|Reported Event|Advanced Notification + Ranitidine|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at, and the subject is randomized to receiving Ranitidine.
413212|NCT00585351|E2|Reported Event|No Advanced Notification + Consent +Not Eligible for Study Med|Subjects in this group are randomized to not receive any advanced notification about the study, so they are not provided the informed consent document until Air Care has arrived to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413213|NCT00585351|E1|Reported Event|Advanced Notification + Consent + Not Eligible for Study Med|Subjects in this group are randomized to receiving advanced notification about the study via a telephone call and faxing of the informed consent document prior to the arrival of Air Care to the outside hospital where the subject is at. Consent is obtained by Air Care, however, after assessments and review of records, the subject is deemed not eligible to be randomized to receive study medication.
413214|NCT00585312|B3|Baseline|Total|Total of all reporting groups
413215|NCT00585312|B2|Baseline|Placebo|Matching placebo
413216|NCT00585312|B1|Baseline|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413217|NCT00585312|P2|Participant Flow|Placebo|Matching placebo
413218|NCT00585312|P1|Participant Flow|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413222|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413223|NCT00585312|O2|Outcome|Placebo|Matching placebo
413224|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413225|NCT00585312|O2|Outcome|Placebo|Matching placebo
413226|NCT00585312|O1|Outcome|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413227|NCT00585312|E2|Reported Event|Placebo|Matching placebo
413228|NCT00585312|E1|Reported Event|Celecoxib|Celecoxib, approximately 16 mg/kg/day (adjusted for changes in body weight). Maximum dose was 400 mg twice daily.
413229|NCT00585286|B1|Baseline|Fractional CO2 Laser System|Thirty healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413230|NCT00585286|P1|Participant Flow|Fractional Carbon Dioxide Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional carbon dioxide laser system.
413231|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413232|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413233|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413234|NCT00585286|O1|Outcome|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413235|NCT00585286|E1|Reported Event|Fractional CO2 Laser System|Fifteen healthy subjects of skin type I-IV received treatment with the 10,600 nm fractional CO2 laser system.
413236|NCT00585221|B1|Baseline|Group 1|
413237|NCT00585221|P1|Participant Flow|All Patients|All participants enrolled.
413238|NCT00585221|O1|Outcome|All Patients|All participants enrolled
413239|NCT00585221|O1|Outcome|All Patients|All participants enrolled
413240|NCT00585221|E1|Reported Event|All Enrolled|All participants enrolled
413241|NCT00585182|B1|Baseline|Enoxaparin 0.5mg/kg Once Daily|
413242|NCT00585182|P1|Participant Flow|Enoxaparin 0.5mg/kg Once Daily|
413243|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
413244|NCT00585182|O1|Outcome|Enoxaparin 0.5mg/kg Once Daily|
413245|NCT00585182|E1|Reported Event|Enoxaparin 0.5mg/kg Once Daily|
413246|NCT00585169|B1|Baseline|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
413247|NCT00585169|P1|Participant Flow|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
413248|NCT00585169|O1|Outcome|Memantine|"10 to 30 mg/day memantine~Memantine Hydrochloride : 10 mg/day for two weeks, dose increase to 20 mg at week 3, 40 mg at week 5 unless clinical improvement is achieved with a lower dose. Total treatment is 10 weeks. Mean dose at study end was 23.4 ± 8.1 mg/day"
413249|NCT00585169|E3|Reported Event|Memantine 30mg|
413250|NCT00585169|E2|Reported Event|Memantine 20mg|
413251|NCT00585169|E1|Reported Event|Memantine 10mg|
413252|NCT00585104|B1|Baseline|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
413253|NCT00585104|P1|Participant Flow|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
413254|NCT00585104|O1|Outcome|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
413255|NCT00585104|E1|Reported Event|Levosimendan, Compare Heart Function and Metabolism|All patients received Levosimendan (12mcg/kg IV bolus over 10 minutes, Abbott Laboratories, Abbott Park, IL). All study measurements occur at baseline and 30-minutes after the initiation of levosimendan.
413256|NCT00585039|B3|Baseline|Total|Total of all reporting groups
413257|NCT00585039|B2|Baseline|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
413258|NCT00585039|B1|Baseline|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
413259|NCT00585039|P2|Participant Flow|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
413260|NCT00585039|P1|Participant Flow|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
413261|NCT00585039|O2|Outcome|Albuterol|
413262|NCT00585039|O1|Outcome|Levalbuterol|
413263|NCT00585039|O2|Outcome|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
413264|NCT00585039|O1|Outcome|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
413265|NCT00585039|E2|Reported Event|Albuterol|patients who received 7.5 mg albuterol nebulization at baseline and could be repeated at 60 minutes
413266|NCT00585039|E1|Reported Event|Levalbuterol (Xopenex)|Patients who received 3.75 mg levalbuterol nebulization at baseline and could be repeated at 60 minutes
413267|NCT00585013|B3|Baseline|Total|Total of all reporting groups
413268|NCT00585013|B2|Baseline|2 Placebo|Placebo delivery of oxygen at standard dose.
413299|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413300|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413269|NCT00585013|B1|Baseline|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413270|NCT00585013|P2|Participant Flow|2 Placebo|Placebo delivery of oxygen at standard dose.
413271|NCT00585013|P1|Participant Flow|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413272|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
413273|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413274|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
413275|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413276|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
413277|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413278|NCT00585013|O2|Outcome|2 Placebo|Placebo delivery of oxygen at standard dose.
413279|NCT00585013|O1|Outcome|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413280|NCT00585013|O2|Outcome|Placebo|Placebo delivery of oxygen at standard dose.
413281|NCT00585013|O1|Outcome|Nitric Oxide Delivery Group|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide: Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413282|NCT00585013|E2|Reported Event|2 Placebo|Placebo delivery of oxygen at standard dose.
413283|NCT00585013|E1|Reported Event|1 Treatment|"Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued.~Nitric Oxide : Patients will receive standard care with the addition of NO gas. During cardiopulmonary bypass, NO at 20 ppm will be added to the sweep gas of the extracorporeal circuit. Following termination of cardiopulmonary bypass, inhaled NO will be discontinued."
413284|NCT00584987|B5|Baseline|Total|Total of all reporting groups
413285|NCT00584987|B4|Baseline|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413286|NCT00584987|B3|Baseline|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413287|NCT00584987|B2|Baseline|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413288|NCT00584987|B1|Baseline|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413289|NCT00584987|P4|Participant Flow|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413290|NCT00584987|P3|Participant Flow|PL FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413291|NCT00584987|P2|Participant Flow|FF + PL OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413292|NCT00584987|P1|Participant Flow|PL FF + PL OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413293|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413294|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413295|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413296|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413297|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413298|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413301|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413302|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413303|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413304|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413305|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413306|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413307|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413308|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413309|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413310|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413311|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413312|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413313|NCT00584987|O4|Outcome|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413314|NCT00584987|O3|Outcome|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413315|NCT00584987|O2|Outcome|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413316|NCT00584987|O1|Outcome|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413317|NCT00584987|E4|Reported Event|FF + OXY|Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413318|NCT00584987|E3|Reported Event|Placebo FF + OXY|Placebo Fluticasone furoate + Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413319|NCT00584987|E2|Reported Event|FF + Placebo OXY|Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413320|NCT00584987|E1|Reported Event|Placebo FF + Placebo OXY|Placebo Fluticasone furoate + Placebo Oxymetazoline, 2 puffs of each nasal spray in each nostril in the pm
413321|NCT00584935|B1|Baseline|Rituximab|
413322|NCT00584935|P1|Participant Flow|Rituximab|
413323|NCT00584935|O1|Outcome|Rituximab|
413324|NCT00584935|E1|Reported Event|Rituximab|
413325|NCT00584909|B1|Baseline|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
413326|NCT00584909|P1|Participant Flow|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
413327|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
413328|NCT00584909|O1|Outcome|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
413329|NCT00584909|E1|Reported Event|Paclitaxel + Carboplatin|Patients are administered 175 mg/m2 paclitaxel and carboplatin (dose based upon the Calvert formula for determining the area under the curve based on the patient's glomerular filtration rate). Drugs will be administered by intravenous infusion every 21 days for 6 cycles.
413330|NCT00584857|B1|Baseline|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
413331|NCT00584857|P1|Participant Flow|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
413332|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
413333|NCT00584857|O1|Outcome|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
413334|NCT00584857|E1|Reported Event|Paclitaxel/Carboplatin/Megesterol Acetate|Paclitaxel will be administered at 175mg/m2) as a 3 hour continuous IV infusion every 21 days. Carboplatin will be administered at a dose utilizing Calvert formula for determining the area under the curve (AUC) based on the patient's glomerular filtration rate. Megesterol Acetate will be given orally four times a day at a dosage of 40 mg.
413335|NCT00584831|B1|Baseline|Total Study Population|
413336|NCT00584831|P19|Participant Flow|Group 17 BSOL|balafilcon A toric, senofilcon A toric,omafilcon A toric, lotrafilcon b toric
416675|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
413337|NCT00584831|P18|Participant Flow|Group 6 SLOB|senofilcon A toric, lotrafilcon b toric, omafilcon A toric, balafilcon A toric
413338|NCT00584831|P17|Participant Flow|Group 3 LOSB|lotrafilcon B toric, omafilcon A toric, senofilcon A toric, balafilcon A toric
413339|NCT00584831|P16|Participant Flow|Group 19 BOSL|balafilcon A toric, omafilcon A toric, senofilcon A toric, lotrafilcon B toric
413340|NCT00584831|P15|Participant Flow|Group 18 BOLS|balafilcon A toric, omafilcon A toric, lotrafilcon B toric, senofilcon A toric
413341|NCT00584831|P14|Participant Flow|Group 16 BLOS|balafilcon A toric, lotrafilcon B toric, omafilcon A toric, senofilcon A toric
413342|NCT00584831|P13|Participant Flow|Group 15 BLSO|balafilcon A toric, lotrafilcon B toric, senofilcon A toric, omafilcon A toric
413343|NCT00584831|P12|Participant Flow|Group 14 OBSL|omafilcon A toric, balafilcon A toric, senofilcon A toric, lotrafilcon B toric
413344|NCT00584831|P11|Participant Flow|Group 13 OBLS|omafilcon A toric, balafilcon A toric, lotrafilcon B toric, senofilcon A toric
413345|NCT00584831|P10|Participant Flow|Group 12 OSBL|omafilcon A toric, senofilcon A toric, balafilcon A toric, lotrafilcon B toric
413346|NCT00584831|P9|Participant Flow|Group 11 OSLB|omafilcon A toric, senofilcon A toric, lotrafilcon B toric, balafilcon A toric
413347|NCT00584831|P8|Participant Flow|Group 10 SBOL|senofilcon A toric, balafilcon A toric, omafilcon A toric, lotrafilcon B toric
413348|NCT00584831|P7|Participant Flow|Group 9 SBLO|senofilcon A toric, balafilcon A toric, lotrafilcon B toric, omafilcon A toric
413349|NCT00584831|P6|Participant Flow|Group 8 SOLB|senofilcon A toric, omafilcon A toric, lotrafilcon B toric, balafilcon A toric
413350|NCT00584831|P5|Participant Flow|Group 7 SLBO|senofilcon A toric, lotrafilcon B toric, balafilcon A toric, omafilcon A toric
413351|NCT00584831|P4|Participant Flow|Group 5 LBOS|lotrafilcon B toric, balafilcon A toric, omafilcon A toric, senofilcon A
413352|NCT00584831|P3|Participant Flow|Group 4 LBSO|lotrafilcon B toric, balafilcon A toric, senofilcon A toric, omafilcon A toric
413353|NCT00584831|P2|Participant Flow|Group 2 LSBO|lotrafilcon B toric, senofilcon A toric, balafilcon A toric, omafilcon A toric
413354|NCT00584831|P1|Participant Flow|Group1 LSOB|lotrafilcon b toric, senofilcon A toric, omafilcon A toric, balafilcon A toric
413355|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
413356|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
413357|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
413358|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
413359|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
413360|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
413361|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
413362|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
413363|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
413364|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
413365|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
413366|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
413367|NCT00584831|O4|Outcome|Balafilcon A|balafilcon A toric
413368|NCT00584831|O3|Outcome|Omafilcon A|omafilcon A toric
413369|NCT00584831|O2|Outcome|Senofilcon A|senofilcon A toric
413370|NCT00584831|O1|Outcome|Lotrafilcon B|lotrafilcon b toric
413371|NCT00584831|E4|Reported Event|Balafilcon A|balafilcon A toric contact lens
413372|NCT00584831|E3|Reported Event|Omafilcon A|omafilcon A toric contact lens
413373|NCT00584831|E2|Reported Event|Senofilcon A|senofilcon A toric contact lens
413374|NCT00584831|E1|Reported Event|Lotrafilcon B|lotrafilcon b toric contact lens
413375|NCT00584740|B3|Baseline|Total|Total of all reporting groups
413376|NCT00584740|B2|Baseline|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413377|NCT00584740|B1|Baseline|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413378|NCT00584740|P2|Participant Flow|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413379|NCT00584740|P1|Participant Flow|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413380|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413381|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413382|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413383|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413384|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413385|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413386|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413387|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413388|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413389|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413390|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413391|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413392|NCT00584740|O2|Outcome|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413393|NCT00584740|O1|Outcome|AIN457|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413394|NCT00584740|E2|Reported Event|Placebo|Matching placebo to AIN457 was given as an infusion at day 1 and day 22.
413395|NCT00584740|E1|Reported Event|AIN457 Twice 10mg/kg|AIN457 10 mg/kg was given as an intravenous infusion at day 1 and day 22.
413396|NCT00584727|B1|Baseline|Completed Population|Only participants that completed the study are included (n=88)
413397|NCT00584727|P6|Participant Flow|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
413398|NCT00584727|P5|Participant Flow|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
413399|NCT00584727|P4|Participant Flow|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
413400|NCT00584727|P3|Participant Flow|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
413401|NCT00584727|P2|Participant Flow|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
413402|NCT00584727|P1|Participant Flow|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
413403|NCT00584727|O3|Outcome|Etafilcon A Sphere|
413404|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413405|NCT00584727|O1|Outcome|Senofilcon A Toric|
413406|NCT00584727|O3|Outcome|Etafilcon A Sphere|
413407|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413408|NCT00584727|O1|Outcome|Senofilcon A Toric|
413409|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413410|NCT00584727|O1|Outcome|Senofilcon A Toric|
413411|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413412|NCT00584727|O1|Outcome|Senofilcon A Toric|
413413|NCT00584727|O3|Outcome|Etafilcon A Sphere|
413414|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413415|NCT00584727|O1|Outcome|Senofilcon A Toric|
413416|NCT00584727|O3|Outcome|Etafilcon A Sphere|
413417|NCT00584727|O2|Outcome|Alphafilcon A Toric|
413418|NCT00584727|O1|Outcome|Senofilcon A Toric|
413419|NCT00584727|E6|Reported Event|Etafilcon A/Alphafilcon A/Senofilcon A|First intervention: etafilcon A sphere contact lenses Second intervention: alphafilcon A toric contact lenses Third intervention: senofilcon A toric contact lenses
413420|NCT00584727|E5|Reported Event|Alphafilcon A/Senofilcon A/Etafilcon A|First intervention: alphafilcon A toric Second intervention: senofilcon A toric Third intervention: etafilcon A sphere
413421|NCT00584727|E4|Reported Event|Senofilcon A/Etafilcon A/Alphafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: alphafilcon A toric contact lenses
413422|NCT00584727|E3|Reported Event|Etafilcon A/Senofilcon A/Alphafilcon A|First Intervention: etafilcon A sphere contact lenses Second Intervention: senofilcon A toric contact lenses Third Intervention: alphafilcon A toric contact lenses
413423|NCT00584727|E2|Reported Event|Alphafilcon A/Etafilcon A/Senofilcon A|First Intervention: alphafilcon A toric contact lenses Second Intervention: etafilcon A sphere contact lenses Third Intervention: senofilcon A toric contact lenses
413424|NCT00584727|E1|Reported Event|Senofilcon A/Alphafilcon A/Etafilcon A|First Intervention: senofilcon A toric contact lenses Second Intervention: alphafilcon A toric contact lenses Third Intervention: etafilcon A sphere contact lenses
413425|NCT00584701|B1|Baseline|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
413426|NCT00584701|P1|Participant Flow|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
413427|NCT00584701|O1|Outcome|Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
413428|NCT00584701|O1|Outcome|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
413429|NCT00584701|E1|Reported Event|Active Risperidone|Risperidone was started at 0.5mg at bedtime for 4 days. If that dosage was tolerated and there were continued behavioral symptoms, the dose was increased to 1mg at bedtime for an additional 4 days. If tolerated and indicated, 0.5mg was added in the morning for a daily total of 1.5 mg.
413430|NCT00584480|B1|Baseline|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
413431|NCT00584480|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
413432|NCT00584480|O1|Outcome|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
413433|NCT00584480|E1|Reported Event|Hyperbaric Oxygen Treatment (HBOT)|Subjects received a total of 80 days (therefore, 80 treatments) over 20 weeks: 40 days of Hyperbaric Oxygen Treatment (HBOT) (1.5 atmosphere absolute; 100 percent oxygen) for 1 hour, 5 days a week for 8 weeks, followed by a 4 week break, and then another 40 days of HBOT over 8 weeks.
413434|NCT00584415|B1|Baseline|PV Isolation + GP Ablation|All patients received pulmonary vein antrum isolation (PV isolation) and ablation of the major atrial ganglionated plexi (superior left GP, inferior left GP, anterior right GP and inferior right GP). Ganglionated plexi (GP) were identified by delivering high-frequency stimulation (20 Hz) from the ablation catheter. If vagal response (AV block) was initiated by stimulation, that site was counted as a GP site and was then ablated.
413435|NCT00584415|P1|Participant Flow|GP Ablation + PV Isolation|All patients in this study received pulmonary vein isolation (PVI) and ganglionated plexi (GP) ablation to treat paroxysmal AF
413436|NCT00584415|O1|Outcome|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
413437|NCT00584415|O1|Outcome|GP Ablation + PV Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
413438|NCT00584415|E1|Reported Event|Experimental Arm (GP Ablation + PV Antrum Isolation)|All patients received high-frequency stimulation (20 Hz) to the presumed GP site to elicit a vagal response (AV block). After all GP sites were ablated, all patients underwent circumferential PV isolation.
413439|NCT00584220|B1|Baseline|All Subjects|Subjects who enrolled and completed the study.
413440|NCT00584220|P2|Participant Flow|Alphafilcon A / Senofilcon A|alphafilcon A toric hydrogel contact lenses worn first, then senofilcon A toric silicone hydrogel contact lenses worn second
413441|NCT00584220|P1|Participant Flow|Senofilcon A / Alphafilcon A|senofilcon A toric silicone hydrogel contact lenses worn first, then alphafilcon A toric hydrogel contact lenses worn second
413442|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
413443|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
413444|NCT00584220|O2|Outcome|Alphafilcon A Toric|contact lenses
413445|NCT00584220|O1|Outcome|Senofilcon A Toric|contact lenses
413446|NCT00584220|E2|Reported Event|Alphafilcon A|alphafilcon A toric hydrogel contact lenses worn
413447|NCT00584220|E1|Reported Event|Senofilcon A|senofilcon A toric silicone hydrogel contact lenses worn
413448|NCT00584077|B1|Baseline|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
413449|NCT00584077|P1|Participant Flow|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
413450|NCT00584077|O1|Outcome|Lung Transplant Recipients With Stable Lung Function|All enrolled subjects underwent bronchoscopy to determine presence of cough as well as the location of airway eliciting a cough response
413451|NCT00584077|E1|Reported Event|Lung Transplant Recipients With Stable Lung Function|Enrolled subjects underwent bronchoscopy to assess for presence of cough reflex in the transpalnted and non-transplanted lung
413452|NCT00583947|B3|Baseline|Total|Total of all reporting groups
413453|NCT00583947|B2|Baseline|LEV/ARF|"Cross-over: Participants treated with levalbuterol 0.63 milligram per nebulization; 7 day washout; arformoterol 7.5 microgram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
413454|NCT00583947|B1|Baseline|ARF/LEV|"Cross-over: Participants treated with arformoterol 7.5 microgram per nebulization; 7 day washout; levalbuterol 0.63 milligram per nebulization.~Open label: 7 day washout; arformoterol 15 microgram per nebulization."
413455|NCT00583947|P2|Participant Flow|LEV/ARF|"Cross-over period: one day active treatment with levalbuterol 0.63 milligram per nebulization followed by a 7 day washout. Then a one day active treatment with arformoterol 7.5 micrograms per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
413456|NCT00583947|P1|Participant Flow|ARF/LEV|"Cross-over period: one day active treatment with arformoterol 7.5 microgram per nebulization followed by a 7 day washout. Then a one day active treatment with levalbuterol 0.63 milligram per nebulization.~Open-label period: Following another 7 day washout, one day treatment with arformoterol 15 micrograms per nebulization."
413457|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413458|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413459|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413460|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413461|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413462|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413463|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413464|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413465|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413466|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413467|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413468|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413469|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413470|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413471|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413472|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413473|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413474|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413475|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413476|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413477|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413478|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413479|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413480|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413481|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413482|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413483|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413484|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413485|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413486|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413487|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413488|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413489|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413490|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413491|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413492|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413493|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413494|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413495|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413496|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413497|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413498|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413499|NCT00583947|O3|Outcome|Arformoterol 15 Mcg|Values represent the experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study
413500|NCT00583947|O2|Outcome|Arformoterol 7.5 Mcg|Values represent the experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study
413501|NCT00583947|O1|Outcome|Levalbuterol 0.63 mg|Values represent participant experience when treated with levalbuterol during the cross-over portion of the study
413502|NCT00583947|E3|Reported Event|Arformoterol 15 Mcg|The experience of participants when treated with arformoterol 15 mcg during the open-label portion of the study.
413503|NCT00583947|E2|Reported Event|Arformoterol 7.5 Mcg|The experience of participants when treated with arformoterol 7.5 mcg during the cross-over portion of the study.
413504|NCT00583947|E1|Reported Event|Levalbuterol 0.63 mg|The experience of participants when treated with levalbuterol during the cross-over portion of the study.
413505|NCT00583908|B1|Baseline|Overall Study Population|Summary for overall study population
413506|NCT00583908|P12|Participant Flow|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413507|NCT00583908|P11|Participant Flow|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413508|NCT00583908|P10|Participant Flow|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413509|NCT00583908|P9|Participant Flow|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413510|NCT00583908|P8|Participant Flow|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413511|NCT00583908|P7|Participant Flow|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413512|NCT00583908|P6|Participant Flow|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413513|NCT00583908|P5|Participant Flow|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413514|NCT00583908|P4|Participant Flow|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413515|NCT00583908|P3|Participant Flow|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413516|NCT00583908|P2|Participant Flow|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413517|NCT00583908|P1|Participant Flow|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413518|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413519|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413520|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413521|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413522|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413523|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413524|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413525|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413526|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413527|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413528|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413529|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413530|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413531|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413532|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413533|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413534|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413535|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413536|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413537|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413538|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413539|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413540|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413541|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413542|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413543|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413544|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413545|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413546|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413547|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413548|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413549|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413550|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413551|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413552|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413553|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413554|NCT00583908|O4|Outcome|Omafilcon A Toric|omafilcon A toric worn in either the first, second, third, or fourth periods.
413555|NCT00583908|O3|Outcome|Lotrafilcon B Toric|lotrafilcon B toric worn in either the first, second, third, or fourth periods.
413556|NCT00583908|O2|Outcome|Balafilcon A Toric|balafilcon A toric worn in either the first, second, third or fourth periods
413557|NCT00583908|O1|Outcome|Senofilcon A Toric|senofilcon A toric worn in either the first, second, third or fourth periods.
413558|NCT00583908|E12|Reported Event|Balafilcon A / Omafilcon A / Lotrafilcon B / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413559|NCT00583908|E11|Reported Event|Balafilcon A / Senofilcon A / Omafilcon A / Lotrafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
416676|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
413560|NCT00583908|E10|Reported Event|Balafilcon A / Senofilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413561|NCT00583908|E9|Reported Event|Balafilcon A / Lotrafilcon B / Omafilcon A / Senofilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413562|NCT00583908|E8|Reported Event|Balafilcon A / Lotrafilcon B / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413563|NCT00583908|E7|Reported Event|Omafilcon A / Lotrafilcon B / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413564|NCT00583908|E6|Reported Event|Senofilcon A / Balafilcon A / Lotrafilcon B / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413565|NCT00583908|E5|Reported Event|Senofilcon A / Omafilcon A / Balafilcon A / Lotrafilcon B|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413566|NCT00583908|E4|Reported Event|Senofilcon A / Lotrafilcon B / Omafilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413567|NCT00583908|E3|Reported Event|Lotrafilcon B / Balafilcon A / Senofilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413568|NCT00583908|E2|Reported Event|Lotrafilcon B / Omafilcon A / Senofilcon A / Balafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413569|NCT00583908|E1|Reported Event|Lotrafilcon B / Senofilcon A / Balafilcon A / Omafilcon A|All lenses were toric lenses. The order of lenses in the title relates to the period of administration.
413570|NCT00583713|B4|Baseline|Total|Total of all reporting groups
413571|NCT00583713|B3|Baseline|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413572|NCT00583713|B2|Baseline|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413573|NCT00583713|B1|Baseline|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413574|NCT00583713|P3|Participant Flow|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413575|NCT00583713|P2|Participant Flow|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413576|NCT00583713|P1|Participant Flow|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413577|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413578|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413579|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413580|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413581|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413582|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413583|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413584|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413585|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413586|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413587|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413588|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413589|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413590|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413591|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413592|NCT00583713|O3|Outcome|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413593|NCT00583713|O2|Outcome|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413594|NCT00583713|O1|Outcome|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413595|NCT00583713|E3|Reported Event|Hepatic Group|BLI-800 oral solution in patients with mild/moderate hepatic impairment.
413596|NCT00583713|E2|Reported Event|Healthy Volunteers|BLI-800 oral solution in healthy volunteers
413597|NCT00583713|E1|Reported Event|Renal Group|BLI-800 oral solution in patients with moderate renal impairment
413598|NCT00583700|B3|Baseline|Total|Total of all reporting groups
413599|NCT00583700|B2|Baseline|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
413600|NCT00583700|B1|Baseline|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
413601|NCT00583700|P2|Participant Flow|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
413602|NCT00583700|P1|Participant Flow|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
413603|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
413604|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
413796|NCT00582556|E1|Reported Event|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413605|NCT00583700|O2|Outcome|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
413606|NCT00583700|O1|Outcome|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
413607|NCT00583700|E2|Reported Event|Intervention: Pentoxifylline & Vitamin E|"Combined treatment with Pentoxifylline and Vitamin E.~Vitamin E : Vitamin E (Over-the-counter) 400 I.U. once daily~Pentoxifylline : Pentoxifylline 400 mg, 3 times daily for 7 months, beginning immediately after radiation therapy."
413608|NCT00583700|E1|Reported Event|Control Arm|Watchful waiting (standard treatment). Study participants received no intervention and were monitored for development of radiation-induced fibrosis.
413609|NCT00583661|B1|Baseline|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
413610|NCT00583661|P1|Participant Flow|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
413611|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
413612|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
413613|NCT00583661|O2|Outcome|Cohort 2|Subjects with Body Surface Area 0.7-1.5m^2
413614|NCT00583661|O1|Outcome|Cohort 1|Subjects with Body Surface Area < 0.7m^2
413615|NCT00583661|E1|Reported Event|EXCOR Pediatric|Implantation of the EXCOR Pediatric Ventricular Assist Device
413616|NCT00583622|B1|Baseline|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
413617|NCT00583622|P1|Participant Flow|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
413618|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
413619|NCT00583622|O1|Outcome|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
413620|NCT00583622|E1|Reported Event|Bevacizumab + High-Dose Chemotherapy|Bevacizumab 5 mg/kg by vein (IV) daily over 90 minutes for 2 Days + Carboplatin 333 mg/m^2 by vein over 2 hours for 3 Days + Docetaxel 300 mg/m^2 by vein over 2 hours for 1 Day + Gemcitabine 1,800 mg/m2 by vein over 3 hours for 4 Days + Melphalan 50 mg/m^2 by vein over 15 minutes for 3 Days + Stem Cell Transplant
413621|NCT00583596|B1|Baseline|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
413622|NCT00583596|P1|Participant Flow|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
413623|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
413624|NCT00583596|O1|Outcome|Long Term Follow-up for Subjects Implanted With the Device|Subjects implanted with Amplatzer duct occluder that have final follow-up taking place 5 yrs., 6 yrs., or 7 yrs., post implant.
413625|NCT00583596|E1|Reported Event|Long Term Follow-up for Subjects Implanted With the Device|Subjects enrolled in IDE study subject to Post Market Surveillance
413626|NCT00583557|B1|Baseline|Belimumab 10 mg/kg|
413627|NCT00583557|P1|Participant Flow|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
413628|NCT00583557|O1|Outcome|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
413629|NCT00583557|E1|Reported Event|Belimumab 10 mg/kg|Subjects received belimumab at a dose of 10 mg/kg IV every 28 days for up to 5 years in this protocol
413630|NCT00583492|B3|Baseline|Total|Total of all reporting groups
413631|NCT00583492|B2|Baseline|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413632|NCT00583492|B1|Baseline|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413633|NCT00583492|P2|Participant Flow|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413634|NCT00583492|P1|Participant Flow|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413635|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413636|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413637|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413797|NCT00582517|B3|Baseline|Total|Total of all reporting groups
413798|NCT00582517|B2|Baseline|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
413638|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413639|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413640|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413641|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413642|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413643|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413644|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413645|NCT00583492|O2|Outcome|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413646|NCT00583492|O1|Outcome|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10e12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413647|NCT00583492|E2|Reported Event|IMRT Alone|"IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy~IMRT: 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy"
413648|NCT00583492|E1|Reported Event|Gene Therapy + IMRT|"Gene Therapy + IMRT~Ad5-yCD/mutTKSR39rep-ADP: 1 x 10^12 sterile injectable solution, 1 injection on day one Plus Radiation - 40 x 2 Gy for a total dose of 80 Gy or 44 x 1.8 Gy for a total dose of 79.2 Gy Plus 2 week course (weekdays only) of 5-FC and vGCV prodrug therapy"
413649|NCT00583219|B1|Baseline|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413650|NCT00583219|P1|Participant Flow|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413651|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413652|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413653|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413799|NCT00582517|B1|Baseline|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
416677|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
413654|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413655|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413656|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413657|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413658|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413659|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413660|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413661|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413682|NCT00582933|O1|Outcome|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
413800|NCT00582517|P2|Participant Flow|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
413662|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413663|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413664|NCT00583219|O1|Outcome|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~The 6 subjects in the Phase 1 trial who received 300 units of botulinum-A toxin and 50cc DMSO also continued in the Phase 2 trial. All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413665|NCT00583219|E1|Reported Event|Botox/DMSO Solution|"Subjects received Botulinum-A toxin and Dimethyl sulfoxide solution. The first 3 subjects in Phase 1 underwent bladder instillation of 50 cc of the solution utilizing 200 units of botulinum-A toxin and 50cc DMSO. The next 6 subjects in the Phase 1 trial received 300 units of botulinum-A toxin and 50cc DMSO.~All subjects in the Phase 2 trial received 300 units of botulinum-A toxin and 50cc DMSO.~Botulinum-A toxin: A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.~Dimethyl sulfoxide (DMSO): Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO."
413666|NCT00583115|B1|Baseline|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
413667|NCT00583115|P1|Participant Flow|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
413668|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
413669|NCT00583115|O1|Outcome|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
413670|NCT00583115|E1|Reported Event|Gleevec|"Drug taken orally 260mg/M2/day once per day~Gleevec: 260 mg/M2/day, given once daily by mouth"
413671|NCT00582972|B1|Baseline|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
413672|NCT00582972|P1|Participant Flow|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
413673|NCT00582972|O1|Outcome|Experimental|Subjects received omeprazole 40 mg daily for 30 days
413674|NCT00582972|O1|Outcome|Experimental|omeprazole 40 mg daily for 30 days
413675|NCT00582972|E1|Reported Event|Experimental|Subjects will receive omeprazole 40 mg daily for 30 days
413676|NCT00582946|B1|Baseline|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
413677|NCT00582946|P1|Participant Flow|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
413678|NCT00582946|O1|Outcome|Maximum Equivalent Pressure Output|Provision of amplification to treat sensorineural hearing loss with direct-drive hearing aid for acute evaluation of efficacy.
413679|NCT00582946|E1|Reported Event|Magnetic Contact Hearing Aid|Subjects were treated with a hearing aid which provided amplification intended to treat mild to moderate sensorineural hearing loss. Acute performance and safety assessed at 4 months compared to unaided baseline pre-treatment, followed by longer-term assessment of safety up to 10 months.
413680|NCT00582933|B1|Baseline|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
413681|NCT00582933|P1|Participant Flow|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
413749|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413750|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413683|NCT00582933|E1|Reported Event|Transplant Patients|BUSULFAN, MELPHALAN, FLUDARABINE, G-CSF: All research participants will be conditioned for transplantation with intravenous busulfan (busulfex®) (0.8- 1.0 mg/Kg/dose Q6H x 10 doses), melphalan (70 mg/m2/dose x 2 doses) and fludarabine (25 mg/m2/day x 5 doses). Doses of busulfan will be adjusted according to plasma levels. All research participants will also receive ATG (thymoglobulin®) prior to transplant to promote engraftment.All research participants will also receive G-CSF posttransplant to foster engraftment.
413684|NCT00582907|B1|Baseline|All Patients Received Both Rilonacept and Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413685|NCT00582907|P4|Participant Flow|Placebo-Rilonacept-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
413686|NCT00582907|P3|Participant Flow|Placebo-Rilonacept-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.
413687|NCT00582907|P2|Participant Flow|Rilonacept-Placebo-Placebo-Rilonacept|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
413688|NCT00582907|P1|Participant Flow|Rilonacept-Placebo-Rilonacept-Placebo|Patients received in the randomized sequence above two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine. Overall study was 12 months.
413689|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413690|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413691|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413692|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413693|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413694|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413695|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413696|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413751|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413697|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413698|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413699|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413700|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413701|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413702|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413703|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413704|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413705|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413706|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413707|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413708|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413709|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413752|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413710|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413711|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413712|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413713|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413714|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413715|NCT00582907|O2|Outcome|Placebo|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413716|NCT00582907|O1|Outcome|Rilonacept|"Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo.~Overall length of study for each participant is 12 months."
413717|NCT00582907|E2|Reported Event|Rilonacept|"Adverse events during rilonacept treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
413718|NCT00582907|E1|Reported Event|Placebo|"Adverse events during placebo treatment. Patients received in randomized sequences two 3-month courses of rilonacept (IL-1 Trap),2.2 mg/kg/wk (max 160 mg) by SC injection and two 3-month courses of equal volume placebo by weekly SC injection. This was in addition to the pre-study dose of colchicine.~Patients were randomized to 4 treatment sequences:~1. rilonacept- placebo-rilonacept-placebo; 2. placebo-rilonacept-placebo-rilonacept 3. rilonacept- placebo-placebo-rilonacept and 4. placebo-rilonacept-rilonacept-placebo."
413719|NCT00582894|B1|Baseline|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413720|NCT00582894|P1|Participant Flow|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413721|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413722|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413723|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413724|NCT00582894|O1|Outcome|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413725|NCT00582894|E1|Reported Event|Reduced Intensity Regimen|Preparative regimen of 1)Busulfex 3.2 mg/kg/day for 2 days, infused over 3 hours, on Day-6 and Day-5 2)Fludarabine 30 mg/m2/day for 5 days on Day-6 to D-2 and 3) Alemtuzumab 10 mg/day IV on days - 5 to -1
413753|NCT00582738|O1|Outcome|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413754|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413726|NCT00582790|B1|Baseline|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413727|NCT00582790|P1|Participant Flow|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413728|NCT00582790|O1|Outcome|Low-dose IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413729|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413730|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413731|NCT00582790|O1|Outcome|IL2 and Zoledronic Acid|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413732|NCT00582790|E1|Reported Event|Zoledronic Acid and Interleukin-2|"Patients 1-6: Zometa at 4mg intravenously on day 1 of each 28-day cycle and IL-2 at a starting dose of 7 MU/m2/day by subcutaneous injection days 1-5, weekly in weeks 1 through 3 of each cycle.~patients 7, 8 and 9: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles.~The last patients: IL-2 at a dose of 1 MU/m2/day by subcutaneous injection days 1-5, on weeks 1 through 3, in four week (28 days) cycles and dose escalation of zometa."
413733|NCT00582738|B3|Baseline|Total|Total of all reporting groups
413734|NCT00582738|B2|Baseline|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413735|NCT00582738|B1|Baseline|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413736|NCT00582738|P2|Participant Flow|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413737|NCT00582738|P1|Participant Flow|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413738|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413739|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413740|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413741|NCT00582738|O1|Outcome|Standard Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413742|NCT00582738|O4|Outcome|Everolimus - Summary of Fibrotest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413743|NCT00582738|O3|Outcome|Standard Treatment -Summary of Fibrotest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413744|NCT00582738|O2|Outcome|Everolimus -Summary of Actitest by Treatment|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413745|NCT00582738|O1|Outcome|Standard Treatment - Summary of Actitest by Treatment|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413746|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413747|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413748|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413982|NCT00581854|O1|Outcome|Group 1|All subjects received R-HyperCVAD induction therapy.
413755|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413756|NCT00582738|O2|Outcome|Everolimus|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413757|NCT00582738|O1|Outcome|CsA-TAC|Continuation of current immunosuppressive regimen (continuation of Calcineurin Inhibitor [CNI] with or without Enteric-coated mycophenolate sodium (myfortic) or mycophenolate mofetil(Cellcept)[MPA], with or without steroids) / no everolimus introduction.
413758|NCT00582738|E2|Reported Event|EVR (Everolimus)|Initiation of everolimus with discontinuation of CNI/MPA, with or without steroids.
413759|NCT00582738|E1|Reported Event|CsA/TAC|Continuation of current immunosuppressive regimen (continuation of CNI with or without MPA, with or without steroids) / no everolimus introduction.
413760|NCT00582712|B1|Baseline|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
413761|NCT00582712|P1|Participant Flow|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
413762|NCT00582712|O1|Outcome|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
413763|NCT00582712|E1|Reported Event|Lithium Capsules|Lithium carbonate: Lithium 300mg by mouth, three times daily, escalated to a lithium level of 0.8-1.2; Continued until progressive disease/unacceptable toxicity; Evaluated every 4 weeks.
413764|NCT00582660|B3|Baseline|Total|Total of all reporting groups
413765|NCT00582660|B2|Baseline|Placebo|1 tablet BID given for 7 days before surgery
413766|NCT00582660|B1|Baseline|Celecoxib|400 mg BID given for 7 days before surgery
413767|NCT00582660|P2|Participant Flow|Placebo|1 tablet BID given for 7 days before surgery
413768|NCT00582660|P1|Participant Flow|Celecoxib|400 mg BID given for 7 days before surgery
413769|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
413770|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
413771|NCT00582660|O2|Outcome|Placebo|1 tablet BID given for 7 days before surgery
413772|NCT00582660|O1|Outcome|Celecoxib|400 mg BID given for 7 days before surgery
413773|NCT00582660|E2|Reported Event|Placebo|1 tablet BID given for 7 days before surgery
413774|NCT00582660|E1|Reported Event|Celecoxib|400 mg BID given for 7 days before surgery
413775|NCT00582556|B4|Baseline|Total|Total of all reporting groups
413776|NCT00582556|B3|Baseline|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413777|NCT00582556|B2|Baseline|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413778|NCT00582556|B1|Baseline|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413779|NCT00582556|P3|Participant Flow|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413780|NCT00582556|P2|Participant Flow|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413781|NCT00582556|P1|Participant Flow|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413782|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413783|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413784|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|Gonadotropin releasing hormone (GnRH) analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413785|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413786|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413787|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413788|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413789|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413790|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413791|NCT00582556|O3|Outcome|Zometa Given Monthly, Months 6-11|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413792|NCT00582556|O2|Outcome|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413793|NCT00582556|O1|Outcome|Zometa Given 7 Days Prior to Beginning ADT|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given 7 days prior to beginning androgen deprivation therapy
413794|NCT00582556|E3|Reported Event|Zometa Given Monthly x 6 Months|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min, given monthly x 6 months, beginning in month 6.
413795|NCT00582556|E2|Reported Event|Zometa Given at Month 6|GnRH analogue 3-mo depot - q3 months for 1 yr and Zometa 4 mg IV over 15 min x 1, given at mo 6
413981|NCT00581854|P1|Participant Flow|Rituximab|Single Arm Maintenance rituximab following induction chemoimmunotherapy
413801|NCT00582517|P1|Participant Flow|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
413802|NCT00582517|O2|Outcome|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
413803|NCT00582517|O1|Outcome|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
413804|NCT00582517|E2|Reported Event|Group B Compass Knee Hinge|Group B will have a Compass Knee Hinge placed
413805|NCT00582517|E1|Reported Event|Group A External Brace|Group A will have a non-invasive range of motion external brace placed following surgery
413806|NCT00582491|B3|Baseline|Total|Total of all reporting groups
413807|NCT00582491|B2|Baseline|Placebo|Participants received a single oral placebo every morning for 16 days
413808|NCT00582491|B1|Baseline|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413809|NCT00582491|P2|Participant Flow|Placebo|Placebo orally everyday for 16 days
413810|NCT00582491|P1|Participant Flow|Modafinil 400mg|Modafinil 400mg orally everyday for 16 days
413811|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413812|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413813|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413814|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413815|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413816|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413817|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413818|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413819|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413820|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413821|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413822|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413823|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413824|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413825|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413826|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413827|NCT00582491|O2|Outcome|Placebo|Participants received a single oral placebo every morning for 16 days
413828|NCT00582491|O1|Outcome|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413829|NCT00582491|E2|Reported Event|Placebo|Participants received a single oral placebo every morning for 16 days
413830|NCT00582491|E1|Reported Event|Modafinil (400mg)|Participants received single oral dose of modafinil (400mg) every morning for 16 days
413831|NCT00582426|B3|Baseline|Total|Total of all reporting groups
413832|NCT00582426|B2|Baseline|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413833|NCT00582426|B1|Baseline|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413834|NCT00582426|P2|Participant Flow|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413835|NCT00582426|P1|Participant Flow|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413836|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413837|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413838|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413839|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413840|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413841|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413842|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413843|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413844|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413845|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413846|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413847|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413848|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413849|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413983|NCT00581854|E1|Reported Event|Group 1|SAEs during induction therapy
413850|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413851|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413852|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413853|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413854|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413855|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413856|NCT00582426|O2|Outcome|Standard Treatment|Physician treatment of choice for chemotherapy induced diarrhea other than Octreotide LAR.
413857|NCT00582426|O1|Outcome|Octreotide Long Acting Release|Octreotide LAR 30 mg, for intramuscular injection every 28 days for 6 months beginning with the first course of chemotherapy.
413858|NCT00582426|E2|Reported Event|Standard Treatment|
413859|NCT00582426|E1|Reported Event|Octreotide LAR|
413860|NCT00582400|B1|Baseline|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413861|NCT00582400|P1|Participant Flow|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413862|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413863|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413864|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413865|NCT00582400|O1|Outcome|Arsenic Trioxide|Patients with advanced measurable HCC, no more than one prior systemic treatment or no treatment, ECOG PS 0-2, and Child-Pugh class A received arsenic trioxide 0.35mg/kg on days 1, 8, 15 and 22 of each 28-day cycle.
413866|NCT00582400|E1|Reported Event|Arsenic Trioxide (Trisenox)|"arsenic trioxide: Trisenox will be diluted with 100 to 250 mL 0.9% Sodium Chloride injection, USP, using proper aseptic technique, immediately after withdrawal from the ampule. The Trisenox ampule is single-use and does not contain any preservatives. Unused portions of each ampule should be discarded properly. Trisenox is not to be mixed with other medications.~The loading dose of Trisenox will be administered intravenously over 2 hours. The infusion duration may be extended up to 4 hours if acute vasomotor reactions are observed. The drug will be administered IV through a functional peripheral or central venous line. Trisenox is not a vesicant, and may be a mild irritant if administered into the skin without dilution."
413867|NCT00582361|B3|Baseline|Total|Total of all reporting groups
413868|NCT00582361|B2|Baseline|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
413869|NCT00582361|B1|Baseline|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
413870|NCT00582361|P2|Participant Flow|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
413871|NCT00582361|P1|Participant Flow|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
413872|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
413873|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
413874|NCT00582361|O2|Outcome|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
413875|NCT00582361|O1|Outcome|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
413876|NCT00582361|E2|Reported Event|Vacuum Assisted Closure Group (2, B)|Group 2,B subjects will have a Vacuum Assisted Closure (VAC) device applied following initial treatment of their open fracture.
413877|NCT00582361|E1|Reported Event|Standard Dressing Group (1, A)|Group 1,A subjects will have a standard dressing applied following initial treatment of their open fracture.
413878|NCT00582309|B4|Baseline|Total|Total of all reporting groups
413879|NCT00582309|B3|Baseline|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
413880|NCT00582309|B2|Baseline|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
413881|NCT00582309|B1|Baseline|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
413882|NCT00582309|P3|Participant Flow|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
413883|NCT00582309|P2|Participant Flow|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
413903|NCT00582075|P1|Participant Flow|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
413884|NCT00582309|P1|Participant Flow|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
413885|NCT00582309|O3|Outcome|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
413886|NCT00582309|O2|Outcome|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
413887|NCT00582309|O1|Outcome|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
413888|NCT00582309|E3|Reported Event|Simple Calculated Intravenous Insulin Infusion|Simple Calculated Intravenous Insulin Infusion Use of of standard sliding scale to adjust insulin dose
413889|NCT00582309|E2|Reported Event|Standard Intravenous Insulin Infusion Algorithm|Standard Intravenous Insulin Infusion Algorithm Use of an algorithm the nurses follow based on previous glucoses and amount of insulin given is used to adjust the insulin dose
413890|NCT00582309|E1|Reported Event|Glucommander-Guided Intravenous Insulin Infusion|Glucommander-Guided Intravenous Insulin Infusion The use of a handheld devive with an alogorithm based on the previous glucoses and insulin given is used to adjust the next insulin dose
413891|NCT00582114|B3|Baseline|Total|Total of all reporting groups
413892|NCT00582114|B2|Baseline|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413893|NCT00582114|B1|Baseline|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413894|NCT00582114|P2|Participant Flow|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413895|NCT00582114|P1|Participant Flow|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other angiotensin converting enzyme (ACE) inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413896|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413897|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413898|NCT00582114|O2|Outcome|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413899|NCT00582114|O1|Outcome|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413900|NCT00582114|E2|Reported Event|Lisinopril|Lisinopril: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413901|NCT00582114|E1|Reported Event|Atenolol|Atenolol: Patients will be randomized into two groups, one that is beta blocker based, the other ACE inhibitor (lisinopril) based. Patients who are on no medications will receive atenolol 25 mg. t.i.w. or lisinopril 10 mg. t.i.w. for one month at the end of which, dose will be titrated to twice the drug doses following monthly interval to another doubling of dose. If BP is still poorly controlled felodipine will be added. Other antihypertensive therapies will be added to control home BP to <140/90 mm Hg.
413902|NCT00582075|B1|Baseline|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
413904|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
413905|NCT00582075|O1|Outcome|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
413906|NCT00582075|E1|Reported Event|Radiosurgery 15-24 Gy + Adjuvant Temozolomide|Patients with newly diagnosed brain mets treated with radiosurgery.
413907|NCT00582036|B3|Baseline|Total|Total of all reporting groups
413908|NCT00582036|B2|Baseline|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
413909|NCT00582036|B1|Baseline|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
413910|NCT00582036|P2|Participant Flow|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
413911|NCT00582036|P1|Participant Flow|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
413912|NCT00582036|O2|Outcome|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
413913|NCT00582036|O1|Outcome|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
413914|NCT00582036|E2|Reported Event|Arm 2|"Baseline IV Insulin infusion begins with:~>220mg/dl - Start at 2 units/hr 110-220mg/dl - Start at 1 unit/hr <110 - Monitor fingerstick before meals and at bedtime~Sliding Scale IV Insulin adjustments based on:~>201mg/dl - Increase by 2 units/hr 141-200mg/dl - Increase by 1 unit/hr 111-140mg/dl - Increase by 0.5 units/hr 81 - 110mg/dl - If blood glucose decreases by 15mg/dl or more, reduce drip by 25% 61-80mg/dl - Reduce infusion by 25% <60 Stop infusion"
413915|NCT00582036|E1|Reported Event|Arm 1|Regular Sliding Scale Insulin per the following >400mg/dl = 12 units 351-400mg/dl = 10 units 301-350mg/dl = 8 units 251-300mg/dl = 6 units 200-250mg/dl = 4 units <200 No insulin
413916|NCT00582010|B3|Baseline|Total|Total of all reporting groups
413917|NCT00582010|B2|Baseline|Placebo (Nitrogen Gas)|80 ppm was administered by inhalation for the duration of surgery
413918|NCT00582010|B1|Baseline|Inhaled Nitric Oxide|80 ppm was administered by inhalation for the duration of surgery
413919|NCT00582010|P2|Participant Flow|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
413920|NCT00582010|P1|Participant Flow|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
413921|NCT00582010|O2|Outcome|Placebo|
413922|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413923|NCT00582010|O2|Outcome|Placebo|
413924|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413925|NCT00582010|O2|Outcome|Placebo|
413926|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413927|NCT00582010|O2|Outcome|Placebo|
413928|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413929|NCT00582010|O2|Outcome|Placebo|
413930|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413931|NCT00582010|O2|Outcome|Placebo|
413932|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413933|NCT00582010|O2|Outcome|Placebo|
413934|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413935|NCT00582010|O2|Outcome|Placebo|
413936|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413937|NCT00582010|O2|Outcome|Placebo|
413938|NCT00582010|O1|Outcome|Inhaled Nitric Oxide|
413939|NCT00582010|E2|Reported Event|2. Placebo|"Placebo (nitrogen)~nitrogen gas : inhaled"
413940|NCT00582010|E1|Reported Event|1. Experimental|"iNO administration~inhaled nitric oxide : inhaled 80ppm for duration of surgery."
413941|NCT00581971|B1|Baseline|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
413942|NCT00581971|P1|Participant Flow|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|Patients with locally advanced head and neck cancer will be treated with weekly carboplatin, paclitaxel, and concurrent radiotherapy. Radiotherapy will be delivered at 1.8 Gy every day, to a maximum dose of 70.2 Gy. Carboplatin will be dosed at AUC=2.0, while paclitaxel will be dosed at 30mg/m2. Celecoxib will be delivered at 400mg twice daily, starting 1 week prior to the onset of radiotherapy to establish constant blood levels.
413943|NCT00581971|O1|Outcome|Recurrence|
413944|NCT00581971|O1|Outcome|Acute Toxicity|Participants that experienced Grade 3 or higher toxicity factors.
413945|NCT00581971|E1|Reported Event|Celecoxib + Carboplatin/Paclitaxel+Radiation Therapy|
413946|NCT00581945|B3|Baseline|Total|Total of all reporting groups
413947|NCT00581945|B2|Baseline|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413948|NCT00581945|B1|Baseline|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413949|NCT00581945|P2|Participant Flow|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413980|NCT00581854|B1|Baseline|Group 1|SAEs during induction therapy
413950|NCT00581945|P1|Participant Flow|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413951|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413952|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413953|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413954|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413955|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413956|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413957|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413958|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413959|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413960|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413961|NCT00581945|O2|Outcome|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413962|NCT00581945|O1|Outcome|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413963|NCT00581945|E2|Reported Event|Placebo|Participants received a matching placebo intravenous infusion at weeks 1, 5, 7, and thereafter every four weeks until completion of the 45-week treatment period.
413964|NCT00581945|E1|Reported Event|Canakinumab|Participants received an initial dose of 1 mg/kg canakinumab via intravenous infusion. Four weeks later, participants received a dose of 3 mg/kg canakinumab, and another dose of 3 mg/kg two weeks later. Thereafter, participants received doses of 6 mg/kg every four weeks until completion of the 45-week treatment period.
413965|NCT00581919|B1|Baseline|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413966|NCT00581919|P1|Participant Flow|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413967|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413968|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413969|NCT00581919|O1|Outcome|Bort, Dex, and Dox With ALCAR|Bort, Dex, and Dox with ALCAR: Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413970|NCT00581919|E1|Reported Event|Bort, Dex, and Dox With ALCAR|Bortezomib 1.3 mg/m2 IV days 1, 4, 8, and 11 Dexamethasone 20 mg PO days 1, 4, 8, and 11 Doxorubicin 15 mg/m2 IV days 1 and 8 Acetyl-L-Carnitine (ALCAR) 1.5 g PO BID days 1-21 Maximum of 8 cycles. Each cycle is 21 days long
413971|NCT00581867|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and insulin first.
413972|NCT00581867|P2|Participant Flow|Intranasal Insulin First, Then Placebo|Participants in this group were randomized to receive Intranasal Insulin at the first fMRI visit and then received Placebo at the second fMRI visit.
413973|NCT00581867|P1|Participant Flow|Placebo First, Then Intranasal Insulin|Participants in this group were randomized to receive placebo at the first fMRI visit and then received Intranasal Insulin at the second fMRI visit.
413974|NCT00581867|O2|Outcome|Placebo|
413975|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
413976|NCT00581867|O2|Outcome|Placebo|
413977|NCT00581867|O1|Outcome|Intranasal Insulin Aspart|
413978|NCT00581867|E2|Reported Event|Placebo|Placebo was administered in either first or second intervention period.
413979|NCT00581867|E1|Reported Event|Intranasal Insulin Aspart|Intranasal Insulin was administered in either first or second intervention period.
413984|NCT00581828|B1|Baseline|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
413985|NCT00581828|P1|Participant Flow|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
413986|NCT00581828|O1|Outcome|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
413987|NCT00581828|E1|Reported Event|Vitamin D|Subjects received vitamin D (50,000 IU daily for 15 days) and maintenance dose vitamin D (50,000 IU twice monthly for 10 months).
413988|NCT00581776|B1|Baseline|VCR-CVAD With Rituximab Maintenance|
413989|NCT00581776|P1|Participant Flow|VCR-CVAD With Rituximab Maintenance|
413990|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
413991|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
413992|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
413993|NCT00581776|O1|Outcome|VCR-CVAD With Rituximab Maintenance|
413994|NCT00581776|E1|Reported Event|VCR-CVAD With Rituximab Maintenance|
413995|NCT00581581|B3|Baseline|Total|Total of all reporting groups
413996|NCT00581581|B2|Baseline|Standard Care|Randomized to standard care (original RCT)
413997|NCT00581581|B1|Baseline|Therapeutic Hypothermia|Randomized to cooling (original RCT)
413998|NCT00581581|P2|Participant Flow|Standard Care|Randomized to standard care (original RCT)
413999|NCT00581581|P1|Participant Flow|Therapeutic Hypothermia|Randomized to cooling (original RCT)
414000|NCT00581581|O2|Outcome|Standard Care|Randomized to standard care (original RCT)
414001|NCT00581581|O1|Outcome|Therapeutic Hypothermia|Randomized to cooling (original RCT)
414002|NCT00581581|E2|Reported Event|Standard Care|Randomized to standard care (original RCT)
414003|NCT00581581|E1|Reported Event|Therapeutic Hypothermia|Randomized to cooling (original RCT)
414004|NCT00581555|B3|Baseline|Total|Total of all reporting groups
414005|NCT00581555|B2|Baseline|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414006|NCT00581555|B1|Baseline|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414007|NCT00581555|P2|Participant Flow|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414008|NCT00581555|P1|Participant Flow|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414009|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414010|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414011|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414012|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414013|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414014|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414015|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414016|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414017|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414018|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414019|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414020|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414021|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414022|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414023|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414024|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414025|NCT00581555|O2|Outcome|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414026|NCT00581555|O1|Outcome|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414027|NCT00581555|E2|Reported Event|Etanercept|Participants were administered a 50 mg dose of etanercept subcutaneously once a week after an initial course of ciclosporin.
414028|NCT00581555|E1|Reported Event|Placebo|Participants were administered placebo subcutaneously once a week after an initial course of ciclosporin.
414029|NCT00581542|B3|Baseline|Total|Total of all reporting groups
414030|NCT00581542|B2|Baseline|Moxifloxacin Ophthalmic Solution|randomization to topical moxifloxacin
414031|NCT00581542|B1|Baseline|Polytrim Ophthalmic Solution|randomization to topical polytrim
414032|NCT00581542|P2|Participant Flow|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
414033|NCT00581542|P1|Participant Flow|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
414034|NCT00581542|O2|Outcome|Polytrim Group|Randomization to polytrim : 1-2 drops four times a day for 8-10 days.
414035|NCT00581542|O1|Outcome|Moxifloxin Group|Randomization to topical moxifloxacin 1-2 drops 3x/day for 8-10 days
414036|NCT00581542|O2|Outcome|Moxifloxacin|
414040|NCT00581529|B1|Baseline|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
414041|NCT00581529|P1|Participant Flow|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
414042|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
414043|NCT00581529|O1|Outcome|Radiotherapy|"Accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.~IMRT: Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy."
414044|NCT00581529|E1|Reported Event|Radiotherapy|Patients on protocol will be treated with accelerated radiotherapy, 3.85 Gy per fraction, bid, for 5 consecutive days for a total dose of 38.5 Gy.
414045|NCT00581399|B3|Baseline|Total|Total of all reporting groups
414046|NCT00581399|B2|Baseline|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
414047|NCT00581399|B1|Baseline|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
414048|NCT00581399|P2|Participant Flow|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
414049|NCT00581399|P1|Participant Flow|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
414050|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
414051|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
414052|NCT00581399|O2|Outcome|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
414053|NCT00581399|O1|Outcome|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
414054|NCT00581399|E2|Reported Event|Standard of Care Chest Tubes|Standard of Care 36 Fr Chest Tubes connected to a Pleur-evac Chest Drainage System for Mediastinal Space Drainage.
414055|NCT00581399|E1|Reported Event|No-NumoChest Tubes|High Vacuum Chest Tubes 13Fr for Pleural Drainage and 22Fr connected to a Vario High Vacuum Pump (Medela) for Mediastinal Space Drainage.
414056|NCT00581386|B4|Baseline|Total|Total of all reporting groups
414057|NCT00581386|B3|Baseline|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414058|NCT00581386|B2|Baseline|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414059|NCT00581386|B1|Baseline|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414060|NCT00581386|P3|Participant Flow|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414061|NCT00581386|P2|Participant Flow|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414062|NCT00581386|P1|Participant Flow|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414063|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414064|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414065|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414066|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414067|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414068|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414069|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414070|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414071|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414072|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414073|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414074|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414075|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414076|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414077|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414078|NCT00581386|O3|Outcome|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414079|NCT00581386|O2|Outcome|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414080|NCT00581386|O1|Outcome|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414081|NCT00581386|E3|Reported Event|ProSeal Laryngeal Mask Airway (PLMA)|Patients were randomly assigned into this group. The patients in this group were intubated with the device PLMA.
414082|NCT00581386|E2|Reported Event|Esophageal Tracheal Combitube(ETC)|Patients were randomly assigned into this group. The patients assisgned to this group were intubated with the device ETC.
414083|NCT00581386|E1|Reported Event|Disposable Laryngeal Tube Suction (LTS-D)|Patients were randomly distributed into this group. The patients assigned to this group were intubated using a new LMA device the LTS-D.
414084|NCT00581360|B1|Baseline|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414085|NCT00581360|P1|Participant Flow|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414086|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414087|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414088|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414089|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414090|NCT00581360|O1|Outcome|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414091|NCT00581360|E1|Reported Event|Bortezomib + Doxorubicin|Patients with incurable adenoid cystic carcinoma of the head and neck who received IV bortezomib and doxorubicin
414092|NCT00581347|B3|Baseline|Total|Total of all reporting groups
414093|NCT00581347|B2|Baseline|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
414094|NCT00581347|B1|Baseline|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
414095|NCT00581347|P2|Participant Flow|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
414096|NCT00581347|P1|Participant Flow|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
414097|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
414098|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
414099|NCT00581347|O2|Outcome|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
414120|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414313|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414100|NCT00581347|O1|Outcome|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
414101|NCT00581347|E2|Reported Event|Standard of Care|Control subjects received standard of care. All practices routinely sent letter or telephone reminders to families who had upcoming scheduled visits, but none used active reminder/recall based on vaccinations.
414102|NCT00581347|E1|Reported Event|Outreach|"The intervention consisted of a tiered protocol, with each step being more intensive and targeting a progressively smaller proportion of adolescents who remained behind in immunizations. The intervention was delivered by trained patient immunization navigators.~Step 1- Patient tracking: We used a web-based database to track the adolescents in the intervention group, record immunizations and preventive visits, and document tasks they performed.~Step 2: Reminders and recall: The navigators performed reminder/recall for adolescents who were eligible for either a vaccination or a preventive care visit. They attempted to contact families by telephone and mail.~Step 3: Home visits: If adolescents remained unvaccinated despite the above steps, the navigators performed a home visit to further assess barriers, promote the importance of preventive care, and encourage families to make appointments."
414103|NCT00581308|B1|Baseline|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414104|NCT00581308|P1|Participant Flow|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414105|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414106|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414107|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414108|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414109|NCT00581308|O1|Outcome|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414110|NCT00581308|E1|Reported Event|PAS Subjects|Subjects with occluder in place upon leaving cath lab
414111|NCT00581256|B3|Baseline|Total|Total of all reporting groups
414112|NCT00581256|B2|Baseline|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414113|NCT00581256|B1|Baseline|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414114|NCT00581256|P2|Participant Flow|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414115|NCT00581256|P1|Participant Flow|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414116|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414117|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414118|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414119|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414147|NCT00581100|P2|Participant Flow|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
416678|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
414121|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414122|NCT00581256|O2|Outcome|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414123|NCT00581256|O1|Outcome|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414124|NCT00581256|E2|Reported Event|3DRT|"Best 3-dimensional standard PWTF technique~3D: All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease"
414125|NCT00581256|E1|Reported Event|IMRT|"Best Delivery-optimized radiotherapy technique (IMRT)~IMRT: All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume."
414126|NCT00581230|B1|Baseline|Laryngoscopy Without RAMP, Then Laryngoscopy With RAMP|First, laryngoscopy was preformed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Positioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™. Second, the Rapid Airway Management Positioner (RAMP) was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, the second time with RAMP, and the laryngeal view was recorded.
414127|NCT00581230|P1|Participant Flow|Entire Study|All the patients first underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope without RAMP. Second, all patients underwent laryngoscopy with RAMP--the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
414128|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|The Cormack Lehane grade glottic view obtained during laryngoscopy with inflated RAMP pillow. In all participants, laryngoscopy with the Rapid Airway Management Positioner (RAMP) was performed second (after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
414129|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|The Cormack Lehane grade view obtained with laryngoscopy when there was no RAMP pillow. In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
414130|NCT00581230|O2|Outcome|Laryngoscopy With RAMP|In this crossover study, all participants then received laryngoscopy with the Rapid Airway Management Positioner (RAMP) (immediately after Laryngoscopy without RAMP). The RAMP was positioned and inflated underneath the patient so that the patient was placed in the optimal sniffing position. The investigator again performed laryngoscopy utilizing the same technique, except that RAMP was used, and the laryngeal view was recorded.
414131|NCT00581230|O1|Outcome|Laryngoscopy Without RAMP|In all participants, laryngoscopy was first performed utilizing a traditional Macintosh size 4 blade laryngoscope (without the Rapid Airway Management Postitioner (RAMP)). The view of the laryngeal aperture was recorded, and a photo was taken by the Airway Cam™.
414132|NCT00581230|E1|Reported Event|Entire Study|This is a crossover study, all the patients 1st underwent mask ventilation and laryngoscopy with Macintosh size 4 blade laryngoscope. After this, the RAMP pillow was inflated for all patients and the ease of Mask ventilation and Cormack Lehane laryngoscopy view with Macintosh size 4 laryngoscope was recorded.
414133|NCT00581113|B3|Baseline|Total|Total of all reporting groups
414134|NCT00581113|B2|Baseline|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
414135|NCT00581113|B1|Baseline|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
414136|NCT00581113|P2|Participant Flow|Standard Whole Brain RT|Standard Whole Brain Radiotherapy
414137|NCT00581113|P1|Participant Flow|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
414138|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
414139|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
414140|NCT00581113|O2|Outcome|Standard Whole Brain RT|Standard Whole Brain RT
414141|NCT00581113|O1|Outcome|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
414142|NCT00581113|E2|Reported Event|Standard Whole Brain RT|Standard Whole Brain RT
414143|NCT00581113|E1|Reported Event|Neural Stem Cell-Preserving Whole Brain RT|Neural Stem Cell-Preserving Whole Brain Radiotherapy
414144|NCT00581100|B3|Baseline|Total|Total of all reporting groups
414145|NCT00581100|B2|Baseline|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414146|NCT00581100|B1|Baseline|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414148|NCT00581100|P1|Participant Flow|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414149|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414150|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414151|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414152|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414153|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414154|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414155|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414156|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414157|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414158|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414159|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414160|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414161|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414162|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414163|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414164|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414165|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414166|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414167|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414168|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414169|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414170|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414171|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414172|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414173|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414174|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414175|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414176|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414177|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414178|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414179|NCT00581100|O2|Outcome|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414180|NCT00581100|O1|Outcome|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414181|NCT00581100|E2|Reported Event|Etanercept: Once Weekly|Etanercept 50 mg SC once weekly for the complete 24 week treatment period
414182|NCT00581100|E1|Reported Event|Etanercept: Twice, Then Once Weekly|Etanercept 50 mg subcutaneous (SC) injection twice weekly for 12 weeks reduced to Etanercept 50 mg once weekly to week 24
414183|NCT00581061|B1|Baseline|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
414184|NCT00581061|P1|Participant Flow|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
414185|NCT00581061|O1|Outcome|Vesicare|Number of people who experienced side effects while taking Vesicare, per study protocol. These are known side effects indicated on the drug label that occur to subjects on this medication.
414186|NCT00581061|O1|Outcome|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
414187|NCT00581061|O1|Outcome|Vesicare|Number of days it takes for subjects to achieve pad free urinary continence
414188|NCT00581061|E1|Reported Event|Vesicare|Number of subjects that were in compliance with the study protocol and took medication for at least one month.
414207|NCT00580957|E2|Reported Event|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
416679|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
414189|NCT00580983|B1|Baseline|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
414190|NCT00580983|P1|Participant Flow|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
414191|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
414192|NCT00580983|O1|Outcome|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
414193|NCT00580983|E1|Reported Event|Chemo-IMRT|"Chemotherapy:~Chemotherapy will consist of Paclitaxel 30mg/m² IV over 1 hour, followed by Carboplatin (AUC 1) IV over 30 minutes, or Carboplatin 100mg/m² per IV over 30 minutes or Cisplatin 100mg/m² per IV over 1 hour, or Cisplatin (80mg/m²) or Carboplatin (AUC 5) IV on day 1 and 5-Fluorouracil (1000mg/m²) as a 24-hour continuous infusion, daily x 4 days.~Intensity-modulated Radiation Therapy (IMRT):~Primary RT: 70 Gy to gross disease and 56-63 Gy to subclinical disease in 35 fractions.~Post-operative RT: 64 Gy to high-risk targets (postoperative tumor bed, first-echelon nodes) and 57.6 Gy to low-risk targets, in 32 fractions."
414194|NCT00580970|B3|Baseline|Total|Total of all reporting groups
414195|NCT00580970|B2|Baseline|Supportive Care (Lovastatin) (Ineligible)|The 20 subjects started Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy). The subjects were ineligible because they did not complete 6 months of Lovastatin.
414196|NCT00580970|B1|Baseline|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
414197|NCT00580970|P1|Participant Flow|Supportive Care (Lovastatin)|"Subjects took Lovastatin on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued for 12 months.~73 subjects enrolled in the study, 72 started treatment, 20 subjects were ineligible for analysis, and a total of 53 evaluable subjects."
414198|NCT00580970|O1|Outcome|Supportive Care (Lovastatin) (Evaluable)|The 53 subjects started Lovastatin treatment on the first day of radiation (either EBRT,external beam radiotherapy, or on the day of brachytherapy) and continued up to 12 months. The subjects were considered evaluable for analysis because they completed 6 months of Lovastatin.
414199|NCT00580970|E1|Reported Event|Supportive Care (Lovastatin)|"Subjects who started treatment on Lovastatin on the first day of radiation therapy (external beam radiation therapy (EBRT) alone, brachytherapy alone, or EBRT followed by brachytherapy).~73 subjects enrolled in the study, 72 started Lovastatin treatment, 20 subjects were ineligible for analysis, and a total of 53 subjects evaluable for analysis. 72 subjects started treatment and were at risk for Adverse Events (AEs) and Serious Adverse Events(SAEs)."
414200|NCT00580957|B3|Baseline|Total|Total of all reporting groups
414201|NCT00580957|B2|Baseline|Intact Then Blocked|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
414202|NCT00580957|B1|Baseline|Blocked Then Intact|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
414203|NCT00580957|P2|Participant Flow|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
414204|NCT00580957|P1|Participant Flow|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
414205|NCT00580957|O2|Outcome|Intact|"Saline will be used instead of trimethaphan during insulin clamp~Intact: Saline IV infusion to simulate trimethaphan infusion in active arm Insulin clamp will be done to determine insulin resistance"
414206|NCT00580957|O1|Outcome|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
416680|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
414208|NCT00580957|E1|Reported Event|Blocked|"Active treatment arm. Transient autonomic blockade with Trimethaphan and blood pressure restoration with L-NMMA will be used during insulin clamp~Blocked: Trimethaphan 4 mg/min IV will be infused for the duration of the study.~L-NMMA 125-500 mcg/k/min IV will be titrated to restore blood pressure to pre-trimethaphan levels Insulin clamp will be used to determine insulin resistance"
414209|NCT00580866|B3|Baseline|Total|Total of all reporting groups
414210|NCT00580866|B2|Baseline|PT Only Group|
414211|NCT00580866|B1|Baseline|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
414212|NCT00580866|P2|Participant Flow|PT Only Group|
414213|NCT00580866|P1|Participant Flow|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
414214|NCT00580866|O2|Outcome|PT Only Group|
414215|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
414216|NCT00580866|O2|Outcome|PT Only Group|
414217|NCT00580866|O1|Outcome|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
414218|NCT00580866|E2|Reported Event|PT Only Group|
414219|NCT00580866|E1|Reported Event|Brace Group|JAS Brace: For approximately 6 weeks after surgery, the brace will be utilized for a period of 30 minutes, 3 times per day. Participants will also receive physical therapy 3 times per week.
414220|NCT00580840|B1|Baseline|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414221|NCT00580840|P4|Participant Flow|PLO + MTX|Placebo (PTO) + Methotrexate (MTX)
414222|NCT00580840|P3|Participant Flow|CZP 200 mg and PLO + MTX|Certolizumab Pegol (CZP) 200 mg and Placebo (PLO) + Methotrexate (MTX)
414223|NCT00580840|P2|Participant Flow|CZP 400 mg and PLO + MTX|Certolizumab Pegol (CZP) 400 mg and Placebo (PLO) + Methotrexate (MTX)
414224|NCT00580840|P1|Participant Flow|Overall|Overall for the Run-in period includes all 333 subjects that entered the study. Overall for the Double-blind period includes all 209 subjects that completed the Run-in period.
414225|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414226|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414227|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414228|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414229|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414230|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414231|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414232|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414233|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414234|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414235|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414236|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414237|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414238|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414239|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414240|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414241|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414242|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414243|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414244|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414245|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414246|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414247|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414248|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414249|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414250|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414251|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414252|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414253|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414254|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414255|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414256|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414257|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414258|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414259|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414260|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414261|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414262|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414263|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414264|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414265|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414266|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414267|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414268|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414269|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414270|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414271|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414272|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414273|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414274|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414275|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414276|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414277|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414278|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
416681|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
414279|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414280|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414281|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414282|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414283|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414284|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414285|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414286|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414287|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414288|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414289|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414290|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414291|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414292|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414293|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414294|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414295|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414296|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414297|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414298|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414299|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414300|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414301|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414302|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414303|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414304|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414305|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414306|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414307|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414308|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414309|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414310|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414311|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414312|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
416728|NCT00575380|O2|Outcome|Vigamox|
414314|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414315|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414316|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414317|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414318|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414319|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414320|NCT00580840|O1|Outcome|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414321|NCT00580840|O3|Outcome|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414322|NCT00580840|O2|Outcome|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414323|NCT00580840|O1|Outcome|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414324|NCT00580840|E4|Reported Event|Placebo + Methotrexate|Placebo administered as two injections every 2 weeks plus a subject specific dose of methotrexate
414325|NCT00580840|E3|Reported Event|Certolizumab Pegol 200 mg and Placebo + Methotrexate|200 mg certolizumab pegol and placebo administered every 2 weeks (one injection of each) plus a subject specific dose of methotrexate
414326|NCT00580840|E2|Reported Event|Certolizumab Pegol 400 mg and Placebo + Methotrexate|400 mg certolizumab pegol given every 4 weeks and placebo given every 4 weeks given as two injections (alternating injections every two weeks) plus a subject specific dose of methotrexate
414327|NCT00580840|E1|Reported Event|Run-in Overall|Overall includes all 333 subjects that entered the Run-in period of the study
414328|NCT00580801|B4|Baseline|Total|Total of all reporting groups
414329|NCT00580801|B3|Baseline|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414330|NCT00580801|B2|Baseline|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414331|NCT00580801|B1|Baseline|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414332|NCT00580801|P3|Participant Flow|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414333|NCT00580801|P2|Participant Flow|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414334|NCT00580801|P1|Participant Flow|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414335|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414336|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414337|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414338|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414339|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414340|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414341|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414422|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414423|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414342|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414343|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414344|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414345|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414346|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414347|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414348|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414349|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414350|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414351|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414352|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414353|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414354|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414355|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414356|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414357|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414358|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414359|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414360|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414361|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414424|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
416729|NCT00575380|O1|Outcome|Azasite|
414362|NCT00580801|O3|Outcome|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414363|NCT00580801|O2|Outcome|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414364|NCT00580801|O1|Outcome|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414365|NCT00580801|E3|Reported Event|Placebo+Pegylated-interferon-alfa-2a+Ribavirin|Matching placebo tablet to telaprevir was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414366|NCT00580801|E2|Reported Event|Telaprevir+Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 mg tablet was administered three times a day orally for 2 weeks along with pegylated-interferon-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 1 to 48.
414367|NCT00580801|E1|Reported Event|Telaprevir and Then Pegylated-interferon-alfa-2a+Ribavirin|Telaprevir 750 milligram (mg) tablet was administered three times a day orally for 2 weeks and after that pegylated-interferon-alfa-2a (180 microgram [mcg] subcutaneous injection [injected under the skin by way of a needle], once weekly) and ribavirin (1000-1200 mg as oral tablet daily) was administered from Week 2 to 50.
414368|NCT00580788|B5|Baseline|Total|Total of all reporting groups
414369|NCT00580788|B4|Baseline|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414370|NCT00580788|B3|Baseline|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414371|NCT00580788|B2|Baseline|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414372|NCT00580788|B1|Baseline|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414373|NCT00580788|P4|Participant Flow|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
414374|NCT00580788|P3|Participant Flow|Group 3|PTHrP (1-36) 5 pmol/kg/hr
414375|NCT00580788|P2|Participant Flow|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
414376|NCT00580788|P1|Participant Flow|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
414377|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
414378|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
414379|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
414380|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414381|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414382|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414383|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414384|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414385|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414386|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414387|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414388|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414389|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414390|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414391|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414392|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414393|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414394|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414395|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414396|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414397|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414398|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414399|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414400|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414401|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
414402|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
414403|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
414404|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
414405|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
414406|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
414407|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
414408|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
414409|NCT00580788|O4|Outcome|Group 4|PTHrP (1-36) 6 picomoles/kg/hr
414410|NCT00580788|O3|Outcome|Group 3|PTHrP (1-36) 5 pmol/kg/hr
414411|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr
414412|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr
414413|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
414414|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
414415|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
414416|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414417|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
414418|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
414419|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
414420|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414421|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
416730|NCT00575380|O2|Outcome|Vigamox|
414425|NCT00580788|O4|Outcome|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week
414426|NCT00580788|O3|Outcome|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week
414427|NCT00580788|O2|Outcome|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week
414428|NCT00580788|O1|Outcome|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414429|NCT00580788|E4|Reported Event|Group 4|PTHrP(1-36) 6 picomoles/kg/hr for one week.
414430|NCT00580788|E3|Reported Event|Group 3|PTHrP(1-36) 5 picomoles/kg/hr for one week.
414431|NCT00580788|E2|Reported Event|Group 2|PTHrP(1-36) 4 picomoles/kg/hr for one week.
414432|NCT00580788|E1|Reported Event|Group 1|PTHrP(1-36) 2 picomoles/kg/hr for one week.
414433|NCT00580723|B1|Baseline|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414434|NCT00580723|P1|Participant Flow|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414435|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414436|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414437|NCT00580723|O1|Outcome|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414438|NCT00580723|E1|Reported Event|Topical PRK 124|Topical PRK 124 (Pyratine-6)(0.125%)
414439|NCT00580671|B4|Baseline|Total|Total of all reporting groups
414440|NCT00580671|B3|Baseline|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414441|NCT00580671|B2|Baseline|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414442|NCT00580671|B1|Baseline|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
414443|NCT00580671|P3|Participant Flow|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414444|NCT00580671|P2|Participant Flow|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414445|NCT00580671|P1|Participant Flow|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/ Cognitive Behavior Therapy (CBT) + Contingency Management (CM) / Behavioral Parent Training (BPT)
414446|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414447|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414448|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
414449|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414450|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414451|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
414452|NCT00580671|O3|Outcome|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414453|NCT00580671|O2|Outcome|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414454|NCT00580671|O1|Outcome|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
414455|NCT00580671|E3|Reported Event|MET/CBT|Motivational Enhancement Therapy (MET)/CBT
414456|NCT00580671|E2|Reported Event|MET/CBT+CM|Motivational Enhancement Therapy (MET)/CBT+CM
414457|NCT00580671|E1|Reported Event|MET/CBT+CM/BPT|Motivational Enhancement Therapy (MET)/CBT+CM/BPT
414458|NCT00580606|B3|Baseline|Total|Total of all reporting groups
414459|NCT00580606|B2|Baseline|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
414460|NCT00580606|B1|Baseline|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
414461|NCT00580606|P2|Participant Flow|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
414462|NCT00580606|P1|Participant Flow|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
414521|NCT00580138|P1|Participant Flow|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
414522|NCT00580138|O1|Outcome|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
416731|NCT00575380|O1|Outcome|Azasite|
414463|NCT00580606|O2|Outcome|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over and receive open label high dose peanut SLIT; the study procedures and schedule are the same as for the Low Dose Peanut SLIT group, the only difference is the maximum maintenance dose is almost 3-fold higher at 3,696 mcg/day. DB=Double Blind, SLIT=Sublingual Immunotherapy, OL=Open Label.
414464|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind to Open Label)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at the Week 116 OFC are unable to consume >= 5,000 mg peanut powder or 10-fold the amount of peanut powder compared to the baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
414465|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
414466|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
414467|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
414468|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
414469|NCT00580606|O1|Outcome|High Dose Peanut SLIT Crossover (Open Label)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After Week 44 of open label therapy, subjects either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy.
414470|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
414471|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
414472|NCT00580606|O2|Outcome|Placebo (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy, mcg=microgram
414523|NCT00580138|E1|Reported Event|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
414473|NCT00580606|O1|Outcome|Low Dose Peanut SLIT (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy, mcg=microgram
414474|NCT00580606|E5|Reported Event|Placebo (DB) Crossed Over to High Dose Peanut SLIT (OL)|After 44 weeks of open label therapy, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. After completion of this Week 44 OFC, subjects then either continue on their peanut protein maintenance dose of 3,696 mcg per day or are allowed to attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
414475|NCT00580606|E4|Reported Event|Low Dose Peanut SLIT (Double Blind to Open Label)|After completion of the 5,000 mg Oral Food Challenge (OFC) at Week 44, subjects/study staff are unblinded and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. Subjects who at their Week 116 Oral Food Challenge (OFC) are not able to consume at least 5,000 mg of peanut powder or 10-fold the amount of peanut powder compared to their baseline OFC will discontinue study therapy. SLIT=Sublingual Immunotherapy
414476|NCT00580606|E3|Reported Event|High Dose Peanut SLIT Crossover Before Wk44 Crossover OFC (OL)|Subjects ingest open label peanut protein (glycerinated peanut allergenic extract) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 3,696 mcg) for >= 8 weeks. After 44 weeks of open label SLIT, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. SLIT=Sublingual Immunotherapy
414477|NCT00580606|E2|Reported Event|Placebo Before Week 44 OFC (Double Blind)|Subjects ingest placebo (glycerin) daily beginning with a dose of 0.000165 mcg, followed by a build-up phase (escalating placebo doses every 2 weeks, achieving a maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects no longer receive placebo dosing but are crossed over into the High Dose Peanut SLIT Crossover (Open Label) group. SLIT=Sublingual Immunotherapy
414478|NCT00580606|E1|Reported Event|Low Dose Peanut SLIT Before Week 44 OFC (Double Blind)|Subjects ingest peanut protein (glycerinated peanut allergenic extract) daily starting with 0.000165 mcg, followed by a build-up phase (escalating peanut doses every 2 weeks, achieving maintenance dose by 36 weeks). Thereafter, subjects are on a maximally tolerated maintenance dose (165 mcg to 1,386 mcg) for >= 8 weeks. After Week 44, subjects are given a 5,000 mg Oral Food Challenge (OFC) using peanut powder. Subjects/study staff are unblinded following this OFC and subjects continue on an open label peanut protein maintenance dose of 1,386 mcg/day or may attempt escalation up to this dose. SLIT=Sublingual Immunotherapy
414479|NCT00580502|B1|Baseline|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
414480|NCT00580502|P1|Participant Flow|Lap-Band|"Low BMI patients who will go through Lap-band surgery.~LAP-BAND® Adjustable Gastric Band (LAGB®): Bariatric surgery: LAGB"
414481|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
414482|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
414483|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
414484|NCT00580502|O1|Outcome|LAGB|LAGB surgery for the patient whose BMI between 30 and 40 kg/m^2
414485|NCT00580502|E1|Reported Event|LAP-BAND® Adjustable Gastric Band (LAGB®) Operations|A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities
414486|NCT00580398|B3|Baseline|Total|Total of all reporting groups
414487|NCT00580398|B2|Baseline|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
414488|NCT00580398|B1|Baseline|Control|Usual care included physician advice to quit smoking.
414489|NCT00580398|P2|Participant Flow|Intervention|Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
414490|NCT00580398|P1|Participant Flow|Control|Usual care included physician advice to quit smoking.
414491|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
414492|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
414493|NCT00580398|O2|Outcome|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
414494|NCT00580398|O1|Outcome|Control|Usual care included physician advice to quit smoking.
414495|NCT00580398|E2|Reported Event|Intervention|12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
414496|NCT00580398|E1|Reported Event|Control|Usual care included physician advice to quit smoking.
414535|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414571|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414497|NCT00580372|B1|Baseline|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
414498|NCT00580372|P1|Participant Flow|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
414499|NCT00580372|O1|Outcome|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
414500|NCT00580372|E1|Reported Event|Study Treatment|"Protocol therapy consists of a remission induction phase with mutually non-cross resistant combinations of vincristine, adriamycin, dexamethasone (VAD), high-dose cyclophosphamide with stem cell procurement and etoposide, dexamethasone, cytarabine, cisplatin (EDAP) followed by two courses of melphalan-based high-dose therapy supported by autologous stem cell transplants 4-6 months apart. Maintenance with interferon alpha will be administered until disease progression.~VAD: 3 Cycles (3rd cycle optional):~Vincristine 0.5 mg/d d 1 – 4 CI Adriamycin 10 mg/m2/d d 1 – 4 CI Dexamethasone 40 mg/d d 1-4, 9-12, 17-20~High-Dose cyclophosphamide: Approximately 5-6 weeks after VAD 2 or 3:~Cytoxan 1.2g/m2/d d 1 – 5 Mesna 3.6 g/m2 d 1~Hemopoietic stem cell procurement: Collection target = 10 x 10^6 cells/kg~EDAP: Approximately 5-6 weeks after high-dose cyclophosphamide"
414501|NCT00580294|B1|Baseline|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
414502|NCT00580294|P1|Participant Flow|Oxymorphone|participants switched to oxymorphone extended release (ER) via both oral and intravenous patient-controlled analgesia (IV-PCA) oxymorphone. After 24 hours, participants were discharged with oral oxymorphone ER and oxymorphone immediate release (IR) as needed
414503|NCT00580294|O1|Outcome|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
414504|NCT00580294|E1|Reported Event|Oxymorphone|oral oxymorphone ER as the basal opioid during the first 24 hours and supplemental IV-PCA oxymorphone as needed during period 1. During period 2, participants underwent a 2-week oral titration. The oxymorphone ER and IR dosages were adjusted up or down as needed to maintain pain control.
414505|NCT00580229|B1|Baseline|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
414506|NCT00580229|P1|Participant Flow|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
414507|NCT00580229|O1|Outcome|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
414508|NCT00580229|E1|Reported Event|Oral Prednisone as a Pretreatment to Rituximab|40mg of oral prednisone given 30 min prior to rituximab as a prophylaxis against acute infusion reactions(AIR), as an alternative to the intravenous methylprednisone as a pretreatment for rituximab.
414509|NCT00580151|B3|Baseline|Total|Total of all reporting groups
414510|NCT00580151|B2|Baseline|Control Group|placebo : 1 dose every 6 hours
414511|NCT00580151|B1|Baseline|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
414512|NCT00580151|P2|Participant Flow|Control Group|placebo : 1 dose every 6 hours
414513|NCT00580151|P1|Participant Flow|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
414514|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
414515|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
414516|NCT00580151|O2|Outcome|Control Group|placebo : 1 dose every 6 hours
414517|NCT00580151|O1|Outcome|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
414518|NCT00580151|E2|Reported Event|Control Group|placebo : 1 dose every 6 hours
414519|NCT00580151|E1|Reported Event|Experimental Group|clonidine : 3-5 microgram per kilogram every 6 hours for 10 days
414520|NCT00580138|B1|Baseline|Stroke or Head & Neck Cancer|Any subject who has suffered a stroke or has some form of head & neck cancer (non-laryngectomee) may be enrolled.
414694|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414524|NCT00580034|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d sc or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414525|NCT00580034|P2|Participant Flow|Donor Apheresis|"Donor must be a sibling, half sibling, parent, child or first cousin familial relationship and 3-5/6 Human Leukocyte Antigen matched related to subject. They must not have any medical condition which would make apheresis and G-CSF administration more than a minimal risk, and should have the following:~Adequate cardiac function by history and physical examination~bilirubin and hepatic transaminases < 2.5 x upper limit of normal~normal hematologic parameters Females should have a negative serum pregnancy test."
414526|NCT00580034|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously(dose will be rounded to the nearest whole vial size and may be divided into bid dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414527|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414528|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414529|NCT00580034|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative allogeneic stem cell transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414530|NCT00580034|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative ASCT in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor: Will receive granulocyte colony stimulating factor (G-CSF) 10-16 mcg/kg/d subcutaneously (dose will be rounded to the nearest whole vial size and may be divided into twice daily dosing). Granulocyte macrophage colony stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneously or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation: Will occur 2-3 times per week by physical exam for toxicity through day 45."
414531|NCT00579982|B1|Baseline|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414532|NCT00579982|P1|Participant Flow|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414533|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414534|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
416732|NCT00575380|E2|Reported Event|Vigamox|
414536|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414537|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414538|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414539|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414540|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414541|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414542|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414543|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414544|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414545|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414546|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414547|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414548|NCT00579982|O1|Outcome|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414549|NCT00579982|E1|Reported Event|Lamotrigine|Orally Disintegrating Tablet (ODT). ODT dosing was to match the dose and regimen of the immediate release (IR) dose the subject was taking at baseline. The mean (standard deviation [SD]) ODT dose was 261.3 (118.9) mg/day.
414550|NCT00579813|B3|Baseline|Total|Total of all reporting groups
414551|NCT00579813|B2|Baseline|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
414552|NCT00579813|B1|Baseline|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
414553|NCT00579813|P2|Participant Flow|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
414554|NCT00579813|P1|Participant Flow|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
414555|NCT00579813|O2|Outcome|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
414556|NCT00579813|O1|Outcome|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
414557|NCT00579813|E2|Reported Event|Obese Subjects|Baseline studies (Oral glucose tolerance test, Dual energy x-ray absorbiometry, Resting metabolic rate, Frequently sampled intravenous glucose tolerance test, biopsies), then 10 weeks treatment on Pioglitazone. Baseline tests are repeated at the end of medication treatment.
414558|NCT00579813|E1|Reported Event|Lean Subjects|Arm 1 was normal subjects on which baseline studies were performed to determine insulin sensitivity, intramyocellular lipid and resting metabolic rate.
414559|NCT00579670|B6|Baseline|Total|Total of all reporting groups
414560|NCT00579670|B5|Baseline|Ziprasidone Unknown|Details are unknown.
414561|NCT00579670|B4|Baseline|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414562|NCT00579670|B3|Baseline|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414563|NCT00579670|B2|Baseline|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414564|NCT00579670|B1|Baseline|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414565|NCT00579670|P5|Participant Flow|Ziprasidone Unknown|Details are unknown.
414566|NCT00579670|P4|Participant Flow|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414567|NCT00579670|P3|Participant Flow|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414568|NCT00579670|P2|Participant Flow|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414569|NCT00579670|P1|Participant Flow|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414570|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414572|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414573|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414574|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414575|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414576|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414577|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414578|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414579|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414580|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414581|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414582|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414583|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414584|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414585|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414586|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414587|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414588|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414589|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414590|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414591|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414592|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414593|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414594|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414595|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414596|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414597|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414598|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414599|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414600|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414601|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414602|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414603|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414604|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414605|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414606|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414607|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414608|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414609|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414610|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414611|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414612|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414613|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414614|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414615|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414616|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414617|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414618|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414619|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414620|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414621|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414622|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414623|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414624|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414625|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414626|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414627|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414628|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414629|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414630|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414631|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414632|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414633|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414634|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414635|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414636|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414637|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414638|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414639|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414640|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414641|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414642|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414643|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414644|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414645|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414646|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414647|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414648|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414649|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414650|NCT00579670|O4|Outcome|Ziprasidone = 160 mg|Ziprasidone 160 mg PO per day.
414651|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg PO per day.
414652|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg PO per day.
414653|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg orally (PO) per day or up to 40 mg intramuscularly (IM) per day.
414654|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414655|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414656|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414657|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414658|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414659|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414660|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414661|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414662|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414663|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414664|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414665|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414666|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414667|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414668|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414669|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414670|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414671|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414672|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414673|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414674|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414675|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414676|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414677|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414678|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414679|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414680|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414681|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414682|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414683|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414684|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414685|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414686|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414687|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414688|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414689|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414690|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414691|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414692|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414693|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414695|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414696|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414697|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414698|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414699|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414700|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414701|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414702|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414703|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414704|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414705|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414706|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414707|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414708|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414709|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414710|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414711|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414712|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414713|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414714|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414715|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414716|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414717|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414718|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414719|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414720|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414721|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414722|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414723|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414724|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414725|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414726|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414727|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414728|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414729|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414730|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414731|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414732|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414733|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414734|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414735|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414736|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414737|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414738|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414739|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414740|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414741|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414742|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414743|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414744|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414745|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414746|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414747|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414748|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414749|NCT00579670|O5|Outcome|Ziprasodone Unknown|Details are unknown.
414750|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414751|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414752|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414753|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
414754|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414755|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414756|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414757|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414758|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414759|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414760|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414761|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414762|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414763|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414764|NCT00579670|O1|Outcome|Ziprasidone Total|Ziprasidone all doses received combined.
414765|NCT00579670|O5|Outcome|Ziprasidone Unknown|Details are unknown.
414766|NCT00579670|O4|Outcome|Ziprasidone >= 160 mg|Ziprasidone 160 mg or greater per day.
414767|NCT00579670|O3|Outcome|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414768|NCT00579670|O2|Outcome|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414769|NCT00579670|O1|Outcome|Ziprasidone < 80 mg|Ziprasidone up to 80 milligrams (mg) per day.
414770|NCT00579670|E10|Reported Event|Above SmPC Ziprasidone > 160 mg|Above SmPC Ziprasidone > 160 mg per day; defined as all participants in FAS population who received at least 1 PO dose above 160 mg per day or any IM dose above 40 mg per day or with an unknown dose or formulation.
414771|NCT00579670|E9|Reported Event|Within SmPC Ziprasidone = 160 mg|Within SmPC Ziprasidone = 160 mg; defined as all participants in the FAS population who had PO doses = 160 mg per day.
414772|NCT00579670|E8|Reported Event|Within SmPC Ziprasidone 120 to < 160 mg|Within SmPC Ziprasidone 120 to < 160 mg; defined as all participants in the FAS population who had PO doses between 120 mg and < 160 mg per day.
414773|NCT00579670|E7|Reported Event|Within SmPC Ziprasidone 80 to < 120 mg|Within SmPC Ziprasidone 80 to < 120 mg; defined as all participants in the FAS population who had PO doses between 80 mg and < 120 mg per day.
414774|NCT00579670|E6|Reported Event|Within SmPC Ziprasidone < 80 mg|Within SmPC < 80 mg per day; defined as all participants in the FAS population who had PO doses up to 80 mg per day and all IM doses up to and including 40 mg per day.
414775|NCT00579670|E5|Reported Event|Ziprasidone Unknown|Details are unknown.
414776|NCT00579670|E4|Reported Event|Ziprasidone >=160 mg|Ziprasidone 160 mg or greater per day.
414777|NCT00579670|E3|Reported Event|Ziprasidone 120 mg to < 160 mg|Ziprasidone between 120 mg and < 160 mg per day.
414778|NCT00579670|E2|Reported Event|Ziprasidone 80 mg to < 120 mg|Ziprasidone between 80 mg and < 120 mg per day.
414779|NCT00579670|E1|Reported Event|Ziprasidone < 80 mg|Ziprasidone up to 80 mg per day.
414780|NCT00579501|B1|Baseline|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
414781|NCT00579501|P1|Participant Flow|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
414782|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
414783|NCT00579501|O1|Outcome|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
414784|NCT00579501|E1|Reported Event|Trabectedin|Trabectedin at a dose of 1.5 milligram per meter square (mg/m^2) was given as an intravenous (iv) infusion (a fluid or a medicine delivered into a vein by way of a needle) over 24-hour every 3 weeks for a minimum of 3 and a maximum of 6 cycles prior to definitive surgery. Dexamethasone 20 mg iv was also administered within 30 minutes before start of each trabectedin infusion.
414785|NCT00579345|B9|Baseline|Total|Total of all reporting groups
414786|NCT00579345|B8|Baseline|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414787|NCT00579345|B7|Baseline|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414788|NCT00579345|B6|Baseline|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414789|NCT00579345|B5|Baseline|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
414790|NCT00579345|B4|Baseline|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414856|NCT00579098|B1|Baseline|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414857|NCT00579098|P2|Participant Flow|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414791|NCT00579345|B3|Baseline|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414792|NCT00579345|B2|Baseline|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414793|NCT00579345|B1|Baseline|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414794|NCT00579345|P8|Participant Flow|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414795|NCT00579345|P7|Participant Flow|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414796|NCT00579345|P6|Participant Flow|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414797|NCT00579345|P5|Participant Flow|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
414798|NCT00579345|P4|Participant Flow|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414799|NCT00579345|P3|Participant Flow|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414800|NCT00579345|P2|Participant Flow|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414801|NCT00579345|P1|Participant Flow|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414802|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a).
414803|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV).
414804|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414805|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414806|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414807|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414808|NCT00579345|O4|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414809|NCT00579345|O3|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 61 years of age) who received only (cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414810|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414811|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414812|NCT00579345|O2|Outcome|eTIV_a Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414813|NCT00579345|O1|Outcome|cTIV Total (Elderly)|Revaccination randomized group total (elderly subjects (>= 65 years of age) who received only cell-culture derived seasonal trivalent influenza vaccine (cTIV) in the deltoid muscle, preferably of the non-dominant arm; or received concomitant pneumococcal vaccine (PV; in opposite arm)).
414814|NCT00579345|O6|Outcome|eTIV_a+PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
414815|NCT00579345|O5|Outcome|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
414816|NCT00579345|O4|Outcome|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) and pneumococcal vaccine (PV; in opposite arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study).
414817|NCT00579345|O3|Outcome|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine (cTIV; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4) study or extension 1 (V58P4E1) study.
414818|NCT00579345|O2|Outcome|FLU (cTIV or eTIV_a)|Elderly subjects (>= 65 years of age) randomized and received only Influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a)).
414819|NCT00579345|O1|Outcome|FLU (cTIV or eTIV_a) + PV|Elderly subjects (>= 65 years of age) randomized and received influenza vaccine (cell-culture derived seasonal trivalent influenza vaccine (cTIV) or influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) concomitantly with pneumococcal vaccine (PV)).
414820|NCT00579345|O4|Outcome|eTIV_a (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) study with influenza virus vaccine (egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414821|NCT00579345|O3|Outcome|cTIV (Elderly)|Revaccination unrandomized group (elderly (>= 61 years of age)subjects who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414822|NCT00579345|O2|Outcome|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4) and Extension 1 (V58P4E1) studies with influenza virus vaccine(egg-derived seasonal trivalent, thiomersal free; eTIV_a) were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414823|NCT00579345|O1|Outcome|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4) and the extension 1 (V58P4E1) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine (cTIV) were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414824|NCT00579345|E8|Reported Event|eTIV_a +PV (Elderly; Concomitant Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were concomitantly revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414825|NCT00579345|E7|Reported Event|eTIV_a (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age)were revaccinated with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] in the deltoid muscle, preferably of the non-dominant arm irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414955|NCT00578929|B4|Baseline|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
414826|NCT00579345|E6|Reported Event|cTIV+PV (Elderly; Concomitant Vaccination )|Revaccination randomized group (elderly subjects (>= 65 years of age)were concomitantly revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV; in the deltoid muscle, preferably of the non-dominant arm] and pneumococcal vaccine [PV; in opposite arm] irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study).
414827|NCT00579345|E5|Reported Event|cTIV (Elderly; FLU Vaccination)|Revaccination randomized group (elderly subjects (>= 65 years of age) were revaccinated with cell-culture derived seasonal trivalent influenza vaccine [cTIV]; in the deltoid muscle, preferably of the non-dominant arm) irrespective of influenza vaccination received in parent (V58P4 [NCT00492063]) study or extension 1 (V58P4E1 [NCT00306527]) study.
414828|NCT00579345|E4|Reported Event|eTIV_a (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) study with influenza virus vaccine [egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414829|NCT00579345|E3|Reported Event|cTIV (Elderly)|Revaccination unrandomized group (elderly subjects (>= 61 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414830|NCT00579345|E2|Reported Event|eTIV_a (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in parent (V58P4 [NCT00492063]) and Extension 1 (V58P4E1 [NCT00306527]) studies with influenza virus vaccine[egg-derived seasonal trivalent, thiomersal free; eTIV_a] were allocated to receive eTIV_a in the deltoid muscle, preferably of the non-dominant arm).
414831|NCT00579345|E1|Reported Event|cTIV (Adults)|Revaccination unrandomized group (adult subjects (18-60 years of age) who were pre-vaccinated in the parent (V58P4 [NCT00492063]) and the extension 1 (V58P4E1 [NCT00306527]) studies and received at least one dose of cell-culture derived seasonal trivalent influenza vaccine [cTIV] were allocated to receive cTIV or subjects who participated only in the parent study and received or were planned to receive cTIV in study E1 were allocated to receive cTIV in the deltoid muscle, preferably of the non-dominant arm).
414832|NCT00579254|B1|Baseline|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
414833|NCT00579254|P1|Participant Flow|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
414834|NCT00579254|O1|Outcome|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
414835|NCT00579254|E1|Reported Event|Caduet|Patients were treated with Caduet (5/10 or 5/20 mg) in this study according to prevailing local clinical practice following the locally approved product labeled recommendations.
414836|NCT00579137|B1|Baseline|Single Group|only one group
414837|NCT00579137|P1|Participant Flow|Participants With SCID or Primary Immunodeficiency Disorder|"Participants received an allogeneic stem cell transplant with the following conditioning:~Day 8 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D7 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D6 Campath 1H as per CAGT SOP, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D5 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D4 Anti-CD45 MAb 400ug/kg over 6 hr, Fludarabine 10 kg or less: 1 mg/kg; > 10 kg: 30 mg/m2~D3 Anti-CD45 MAb 400ug/kg over 6 hr~D2 Anti-CD45 MAb 400ug/kg over 6 hr~D1 rest~D0 Stem Cell Infusion~Campath dose is weight based: for patients less than 15 kg administer Campath 3 mg; for patients >15 kg to 30 kg administer Campath 5 mg; for patients > 30 kg administer Campath 10 mg. Campath will be dosed and administered as per CAGT SOP.~Anti-CD45 infusion will be administered according to CAGT SOPs."
414838|NCT00579137|O1|Outcome|Single Group|only one group
414839|NCT00579137|O1|Outcome|Single Group|only one group
414840|NCT00579137|O1|Outcome|Single Group|only one group
414841|NCT00579137|O1|Outcome|Single Group|only one group
414842|NCT00579137|E1|Reported Event|Single Group|only one group
414843|NCT00579111|B3|Baseline|Total|Total of all reporting groups
414844|NCT00579111|B2|Baseline|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
414845|NCT00579111|B1|Baseline|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
414846|NCT00579111|P2|Participant Flow|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
414847|NCT00579111|P1|Participant Flow|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
414848|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
414849|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
414850|NCT00579111|O2|Outcome|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
414851|NCT00579111|O1|Outcome|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
414852|NCT00579111|E2|Reported Event|Unrelated Matched or Single Antigen Mismatched Transplant|Recipients of unrelated matched or single antigen mismatched donor stem cell transplant or single antigen mismatched family donor stem cell transplants
414853|NCT00579111|E1|Reported Event|HLA-identical Sibling Transplant|Recipients of HLA identical sibling stem cell transplants
414854|NCT00579098|B3|Baseline|Total|Total of all reporting groups
414855|NCT00579098|B2|Baseline|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414858|NCT00579098|P1|Participant Flow|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414859|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414860|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414861|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414862|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414863|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414864|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414865|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414866|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414867|NCT00579098|O2|Outcome|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414868|NCT00579098|O1|Outcome|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414869|NCT00579098|E2|Reported Event|Placebo|Placebo (dummy) tablet taken once daily by mouth for 90 days
414870|NCT00579098|E1|Reported Event|Atorvastatin|Lipitor (atorvastatin) 80 mg tablet taken once daily by mouth for 90 days
414871|NCT00579059|B3|Baseline|Total|Total of all reporting groups
414872|NCT00579059|B2|Baseline|Maxim® Regular Tibia|Tibia with Modular Polyethylene
414873|NCT00579059|B1|Baseline|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
414874|NCT00579059|P2|Participant Flow|Maxim® Regular Tibia|Tibia with Modular Polyethylene
414875|NCT00579059|P1|Participant Flow|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
414876|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
414877|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
414878|NCT00579059|O2|Outcome|Maxim® Regular Tibia|Tibia with Modular Polyethylene
414879|NCT00579059|O1|Outcome|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
414880|NCT00579059|E2|Reported Event|Maxim® Regular Tibia|Tibia with Modular Polyethylene
414881|NCT00579059|E1|Reported Event|Maxim® Pop-Top® Tibia|tibia with removable polyethylene
414882|NCT00578968|B4|Baseline|Total|Total of all reporting groups
414883|NCT00578968|B3|Baseline|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
414884|NCT00578968|B2|Baseline|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414885|NCT00578968|B1|Baseline|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414886|NCT00578968|P3|Participant Flow|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
414887|NCT00578968|P2|Participant Flow|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414888|NCT00578968|P1|Participant Flow|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414889|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414890|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414891|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414892|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414893|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414894|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414895|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414896|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414897|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414898|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414899|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414900|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414901|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414902|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414956|NCT00578929|B3|Baseline|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
414903|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414904|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414905|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414906|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414907|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414908|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414909|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414910|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414911|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414912|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414913|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414914|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414915|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414916|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414917|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414918|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414919|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414920|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414921|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414922|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414923|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414924|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414925|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414926|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414927|NCT00578968|O2|Outcome|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414928|NCT00578968|O1|Outcome|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414929|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414930|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414931|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414932|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414933|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414934|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414935|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414936|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414937|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414938|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414939|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414940|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414941|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414942|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414943|NCT00578968|O2|Outcome|Healthy Controls|Healthy age and gender matched controls were recruited for the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with COPD participants.
414944|NCT00578968|O1|Outcome|COPD Participants|All of the COPD participants were included in the first period prior to the intervention to compare cardiovascular responses to resting and exercise states with healthy controls.
414945|NCT00578968|E3|Reported Event|Healthy Controls|Healthy age and gender matched controls were recruited for comparing cardiovascular responses to participants with chronic obstructive pulmonary disease prior to the intervention.
414946|NCT00578968|E2|Reported Event|Placebo|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of placebo powder to match the standard active comparator dose.
414947|NCT00578968|E1|Reported Event|Tiotropium|Participants with chronic obstructive pulmonary disease randomized to this arm received a once daily oral inhalation of 18 mcg tiotropium powder.
414948|NCT00578942|B1|Baseline|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Patient Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414949|NCT00578942|P1|Participant Flow|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414950|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414951|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414952|NCT00578942|O1|Outcome|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Donor will receive Granulocyte colony-stimulating factor (G-CSF) 8 mcg/kg/d subcutaneously twice daily (dose will be rounded to the nearest whole vial size), Granulocyte-macrophage colony-stimulating factor (GM-CSF) 15 mcg/kg/d subcutaneous or similar growth factor for donor mobilization. Donors will receive at least 3-6 doses of daily growth factor until adequate cells are mobilized.~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414953|NCT00578942|E1|Reported Event|Campath Purged Non-myeloablative ASCT|"Campath Purged Non-myeloablative Allo Stem Cell Transplant (ASCT) in lymphoma, myeloma, or marrow failure: leukemia or myelodysplasia; and solid tumors~Preparative regimen: Begins on day -5 and consist of 4 days of daily fludarabine at 30 mg/m2/d infused over 30 minutes, cyclophosphamide 500 mg/m2/d infused over 1 hour, 5 days of Campath-1H at 20 mg/d in 250 ml of D5 normal saline or normal saline infused over 3 hours.~Subject Evaluation will occur 2-3 times per week by physical exam for toxicity through day 45."
414954|NCT00578929|B5|Baseline|Total|Total of all reporting groups
414957|NCT00578929|B2|Baseline|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
414958|NCT00578929|B1|Baseline|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
414959|NCT00578929|P4|Participant Flow|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
414960|NCT00578929|P3|Participant Flow|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
414961|NCT00578929|P2|Participant Flow|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
414962|NCT00578929|P1|Participant Flow|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
414963|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
414964|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
414965|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
414966|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
414967|NCT00578929|O4|Outcome|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
414968|NCT00578929|O3|Outcome|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
414969|NCT00578929|O2|Outcome|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
414970|NCT00578929|O1|Outcome|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
414971|NCT00578929|E5|Reported Event|Vehicle Run-in Period|Vehicle Run-in Period
414972|NCT00578929|E4|Reported Event|Vehicle 2 Sprays|Vehicle 2 sprays per nostril twice daily
414973|NCT00578929|E3|Reported Event|Olopatadine 0.6% 2 Sprays|Olopatadine HCl 0.6% 2 Sprays per nostril twice daily
414974|NCT00578929|E2|Reported Event|Vehicle 1 Spray|Vehicle 1 spray per nostril twice daily
414975|NCT00578929|E1|Reported Event|Olopatadine 0.6% 1 Spray|Olopatadine HCl 0.6% 1 spray per nostril twice daily
414976|NCT00578903|B1|Baseline|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414977|NCT00578903|P1|Participant Flow|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414978|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414979|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414980|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414981|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414982|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414983|NCT00578903|O1|Outcome|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414984|NCT00578903|E1|Reported Event|Patients|Patients with a diagnosis of severe aplastic anemia who require an allogeneic stem cell transplant but lack an Human Leukocyte Antigen (HLA) identical family member.
414985|NCT00578864|B3|Baseline|Total|Total of all reporting groups
414986|NCT00578864|B2|Baseline|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414987|NCT00578864|B1|Baseline|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414988|NCT00578864|P2|Participant Flow|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414989|NCT00578864|P1|Participant Flow|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414990|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414991|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414992|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414993|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414994|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414995|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414996|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414997|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
414998|NCT00578864|O2|Outcome|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
414999|NCT00578864|O1|Outcome|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
415000|NCT00578864|E2|Reported Event|Phase II Window With Bolus Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Bolus Etoposide
415001|NCT00578864|E1|Reported Event|Phase II Window With Protracted Etoposide|2 cycles of induction therapy for patients who received the Phase II window with Protracted Etoposide
415002|NCT00578812|B3|Baseline|Total|Total of all reporting groups
415065|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
415003|NCT00578812|B2|Baseline|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415004|NCT00578812|B1|Baseline|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415005|NCT00578812|P2|Participant Flow|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415006|NCT00578812|P1|Participant Flow|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415007|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415008|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415009|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415010|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415011|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415012|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415013|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415014|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415015|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415016|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415017|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415018|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415019|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415020|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415021|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415022|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415023|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415024|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415025|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415026|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415027|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415028|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415029|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415030|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415031|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415032|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415033|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415034|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415035|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415036|NCT00578812|O1|Outcome|PCM Cervical Disc - Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415037|NCT00578812|O2|Outcome|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415038|NCT00578812|O1|Outcome|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415039|NCT00578812|E2|Reported Event|Anterior Cervical Discectomy and Fusion - Control Group|Anterior cervical discectomy and fusion (ACDF) using a cervical plate and bone graft in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415040|NCT00578812|E1|Reported Event|PCM Cervical Disc-Investigational|PCM Cervical Disc replacement in patients with degenerated cervical discs and neurological symptoms at one level from C3 to T1
415041|NCT00578786|B4|Baseline|Total|Total of all reporting groups
415042|NCT00578786|B3|Baseline|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
415043|NCT00578786|B2|Baseline|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
415044|NCT00578786|B1|Baseline|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
415045|NCT00578786|P3|Participant Flow|Ambrisentan 10 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies).
415046|NCT00578786|P2|Participant Flow|Ambrisentan 5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, a third starting at 5 mg were titrated to 10 mg.
415047|NCT00578786|P1|Participant Flow|Ambrisentan 2.5 mg|Original randomized dose group in the prior study (NCT00423748 and NCT00423202) or in the current study (for subjects originally randomized to placebo in one of the prior studies). Analysis included those not enrolling in this study but received AMB in 1 of the 2 parent studies. It should be noted that by Year 3, almost half of those randomized to AMB 2.5 mg were titrated to 5 mg and 10 mg.
415048|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415049|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415050|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of AMB received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415051|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415052|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415053|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415054|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415055|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415056|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415057|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415058|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415059|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415060|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415061|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415062|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415063|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
415064|NCT00578786|O1|Outcome|Combined Ambrisentan Group|(All Doses)
415066|NCT00578786|O1|Outcome|Combined Ambrisentan Group|All dose groups combined.
415067|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415068|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415069|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415070|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415071|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415072|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415073|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415074|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415075|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415076|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415077|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415078|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415079|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415080|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415081|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415082|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415083|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415084|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415085|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415086|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415087|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415088|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415089|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415090|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415091|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415092|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415093|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415094|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415095|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415096|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415097|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415098|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415099|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415100|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415101|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
416733|NCT00575380|E1|Reported Event|Azasite|
415102|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415103|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415104|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415105|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415106|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415107|NCT00578786|O4|Outcome|Ambrisentan Combined Group|All dose groups combined.
415108|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415109|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415110|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415111|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415112|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415113|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415114|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of ambrisentan in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415115|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415116|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415117|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415118|NCT00578786|O4|Outcome|Combined Ambrisentan Group|All dose groups combined.
415119|NCT00578786|O3|Outcome|Ambrisentan 10 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415120|NCT00578786|O2|Outcome|Ambrisentan 5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415121|NCT00578786|O1|Outcome|Ambrisentan 2.5 mg|Participants were classified based on their randomized dose of AMB in the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415122|NCT00578786|E3|Reported Event|Ambrisentan 10 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415123|NCT00578786|E2|Reported Event|Ambrisentan 5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415124|NCT00578786|E1|Reported Event|Ambrisentan 2.5 mg|Participants were classified based on the highest dose of ambrisentan received at any time during the 2 prior studies (NCT00423748 or NCT00423202) or in the current extension study. Study drug was taken once daily.
415125|NCT00578734|B3|Baseline|Total|Total of all reporting groups
415126|NCT00578734|B2|Baseline|Sham Air|Sham air (placebo) instillation
415127|NCT00578734|B1|Baseline|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
415128|NCT00578734|P2|Participant Flow|Sham Air|Sham air (placebo) instillation
415129|NCT00578734|P1|Participant Flow|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
415130|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
415131|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
415132|NCT00578734|O2|Outcome|Sham Air|Sham air (placebo) instillation
415133|NCT00578734|O1|Outcome|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
415134|NCT00578734|E2|Reported Event|Sham Air|Sham air (placebo) instillation
415135|NCT00578734|E1|Reported Event|Lucinactant|KL₄Surfactant (lucinactant) endotracheal instillation
415136|NCT00578617|B3|Baseline|Total|Total of all reporting groups
415137|NCT00578617|B2|Baseline|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
415138|NCT00578617|B1|Baseline|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
415205|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415139|NCT00578617|P2|Participant Flow|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
415140|NCT00578617|P1|Participant Flow|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
415141|NCT00578617|O2|Outcome|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
415142|NCT00578617|O1|Outcome|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
415143|NCT00578617|E2|Reported Event|Ablation Therapy|Left Atrial Catheter Ablation: The specific choice of ablation catheters will be left to the investigator from the following list: Lifewire TC XLS, Therapy Dual/Thermocouple, NAVI-STAR/NAVI-STAR DS, Celsius Braided Tip, NAVI-STAR Thermo-Cool, Freezor/FreezorMax, Stinger, Blazer II RF/RPM/SteeroCath /XP, Chilli Cooled.
415144|NCT00578617|E1|Reported Event|Drug Therapy|Pharmacologic Therapy Rate and/or Rhythm Control: MD to choose from this list as medically indicated, doses are min recommended daily dose: metoprolol 50-100 mg, atenolol 50-100 mg, propanolol 40-80 mg, acebutolol 200 mg, carvedilol 6.25 mg, diltiazem 180-240 mg, verapamil 180-240 mg, digoxin 0.125 mg, propafenone 450 mg, flecainide 200 mg, sotalol 240 mg, dofetilide 500 mcg, amiodarone 200 mg, quinidine 600-900 mcg.
415145|NCT00578565|B1|Baseline|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415146|NCT00578565|P1|Participant Flow|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415147|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
415148|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415149|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415150|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415151|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V. on each days 1 and 15 with repeat dosing at 6 months
415152|NCT00578565|O1|Outcome|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415153|NCT00578565|E1|Reported Event|Rituximab|open label, all subjects will receive Rituximab 1000 mg. I.V.on each days 1 and 15 with repeat dosing at 6 months
415154|NCT00578552|B4|Baseline|Total|Total of all reporting groups
415155|NCT00578552|B3|Baseline|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415156|NCT00578552|B2|Baseline|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415157|NCT00578552|B1|Baseline|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415158|NCT00578552|P3|Participant Flow|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415159|NCT00578552|P2|Participant Flow|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415160|NCT00578552|P1|Participant Flow|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415161|NCT00578552|O3|Outcome|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415162|NCT00578552|O2|Outcome|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415163|NCT00578552|O1|Outcome|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415164|NCT00578552|E3|Reported Event|Gabapentin - 2700 mg/Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 900 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415165|NCT00578552|E2|Reported Event|Gabapentin - 1800 mg /Day|Gabapentin was initiated at a dose of 300 mg by mouth in the morning and night. The dose was increased over the first 2 weeks to the target doses of 600 mg three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415166|NCT00578552|E1|Reported Event|Placebo|Placebo pill was identical in appearance to the active medication. Initial dosage consisted of 1 pill by mouth in the morning and night. The dose was increased over the first 2 weeks to the target frequency of three times a day. This dose was continued for the next 9 weeks and tapered in the last week. The medication was stopped at the end of 12 weeks.
415167|NCT00578539|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
415168|NCT00578539|P1|Participant Flow|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
415169|NCT00578539|O1|Outcome|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
415170|NCT00578539|E1|Reported Event|Stem Cell Transplant|All patients will receive Ara C IV every 12 hours for 6 doses starting at 1400 hours on day -8. Cyclophosphamide IV once daily on day -7 and day -6 starting at 1400 hours. MESNA will be administered 15 minutes prior to each dose of Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Campath 1h will be given on day -4, day -3, day -2 and day-1. TBI (Total Body Irradiation) will be delivered in 8 fractions of 1.75 Gy in two fractions on day -4, day -3, day -2, and day -1. Stem cell Infusion are infused on day 0.
415171|NCT00578461|B1|Baseline|Stem Cell Transplant|All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.
415172|NCT00578461|P1|Participant Flow|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide.~Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
415173|NCT00578461|O1|Outcome|Stem Cell Transplant|All patients will be receiving a stem cell transplant on study. Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation.
415174|NCT00578461|E1|Reported Event|Stem Cell Transplant|"All patients will receive stem cell transplantation conditioning, GVHD prevention and stem cell infusion.~Conditioning includes: Ara C, Cyclophosphamide, MESNA, TBI-Total Body Irradiation. Ara C: 3000 mg/m^2 - pts will receive via IV every 12 hours for 6 doses starting at 20:00 hours on day -8.Mesna: 45 mg/kg; divided into 5 doses-will be administered 15 minutes prior to Cyclophosphamide and 3, 6, 9, and 12 hours after each dose of Cyclophosphamide. Cyclophosphamide: 45 mg/kg; IV once daily on day -7 and day -6 starting at 1400 hours.TBI-Total Body Irradiation: Total dose 12 Gy, will be delivered in 8 fractions of 150 cGy, each, two fractions per day beginning day -4 to day -1. Stem cell Infusion is on day 0."
415175|NCT00578448|B1|Baseline|IV Belatacept 10mg/kg With 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial.
415176|NCT00578448|P1|Participant Flow|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 4 (Weeks 8 and 12). After 4 months, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the trial (3 years and then a 1 year extension was available for those who completed the 3rd year).
415177|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415178|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415179|NCT00578448|O1|Outcome|Belatacept 10mg/kg; 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study (3 years planned study; 1 year extension allowed to those who completed 3rd year).
415244|NCT00578318|E2|Reported Event|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
415180|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415181|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415182|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415183|NCT00578448|O1|Outcome|10mg/kg IV Belatacept|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415184|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415185|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415186|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415187|NCT00578448|O1|Outcome|Belatacept 10mg/kg(3 Months); 5mg/kg Maintenance|Participants received intravenous (IV) belatacept (10 milligram per kilogram body weight (mg/kg) on Days 1 and 5, and then every 2 weeks through Month 1 (Weeks 2 and 4), and then every 4 weeks through Month 3. After Day 112, participants received a maintenance dose of 5 mg/kg belatacept administered every 4 weeks until completion of the study.
415188|NCT00578448|E1|Reported Event|Bela 10-5mg/kg|
415189|NCT00578383|B5|Baseline|Total|Total of all reporting groups
415190|NCT00578383|B4|Baseline|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415191|NCT00578383|B3|Baseline|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415192|NCT00578383|B2|Baseline|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415193|NCT00578383|B1|Baseline|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415194|NCT00578383|P4|Participant Flow|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415195|NCT00578383|P3|Participant Flow|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415196|NCT00578383|P2|Participant Flow|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415197|NCT00578383|P1|Participant Flow|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415198|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
415199|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415200|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415201|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415202|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
415203|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415204|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415543|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415206|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
415207|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415208|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415209|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415210|NCT00578383|O2|Outcome|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active
415211|NCT00578383|O1|Outcome|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415212|NCT00578383|O2|Outcome|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415213|NCT00578383|O1|Outcome|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415214|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415215|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
415216|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415217|NCT00578383|O1|Outcome|Combined Groups Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
415218|NCT00578383|O2|Outcome|Combined Groups Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415219|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
415220|NCT00578383|O2|Outcome|Combined Group Sham LFMS Treatment|Combined diagnostic groups receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415221|NCT00578383|O1|Outcome|Combined Group Active LFMS Treatment|Combined diagnostic groups receiving active treatment with the Low Field Magnetic Stimulation Device.
415222|NCT00578383|E4|Reported Event|Major Depressive Disorder Sham LFMS Treatment|Subjects with major depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415223|NCT00578383|E3|Reported Event|Major Depressive Disorder Active LFMS Treatment|Subjects with major depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415224|NCT00578383|E2|Reported Event|Bipolar Disorder Sham LFMS Treatment|Subjects with bipolar depression receiving sham treatment with the Low Field Magnetic Stimulation Device. The sham treatment is identical to the active treatment, with the exception that subjects to not receive the active stimulation.
415225|NCT00578383|E1|Reported Event|Bipolar Disorder Active LFMS Treatment|Subjects with bipolar depression receiving active treatment with the Low Field Magnetic Stimulation Device.
415226|NCT00578331|B3|Baseline|Total|Total of all reporting groups
415227|NCT00578331|B2|Baseline|Olopatadine 0.6% Nasal Spray|
415228|NCT00578331|B1|Baseline|Placebo Nasal Spray|
415229|NCT00578331|P2|Participant Flow|Olopatadine 0.6% Nasal Spray|2 sprays each nostril twice daily
415230|NCT00578331|P1|Participant Flow|Placebo Nasal Spray|2 sprays each nostril twice daily
415231|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
415232|NCT00578331|O1|Outcome|Placebo Nasal Spray|
415233|NCT00578331|O2|Outcome|Olopatadine 0.6% Nasal Spray|
415234|NCT00578331|O1|Outcome|Placebo Nasal Spray|
415235|NCT00578331|E2|Reported Event|Olopatadine 0.6% Nasal Spray|
415236|NCT00578331|E1|Reported Event|Placebo Nasal Spray|
415237|NCT00578318|B3|Baseline|Total|Total of all reporting groups
415238|NCT00578318|B2|Baseline|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
415239|NCT00578318|B1|Baseline|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
415240|NCT00578318|P2|Participant Flow|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
415241|NCT00578318|P1|Participant Flow|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
415242|NCT00578318|O2|Outcome|Delayed Control|At the conclusion of enrollment of all active patients, delayed control patients were offered opportunity to receive culturally relevant Motivational Interviewing intervention.
415243|NCT00578318|O1|Outcome|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
415245|NCT00578318|E1|Reported Event|Motivational Interviewing Active|2 sessions with parent/legal guardian and adolescent study patient of culturally relevant Motivational Interviewing intervention
415247|NCT00578305|B3|Baseline|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415248|NCT00578305|B2|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415249|NCT00578305|B1|Baseline|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415250|NCT00578305|P3|Participant Flow|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415251|NCT00578305|P2|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415252|NCT00578305|P1|Participant Flow|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415253|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415254|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415255|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415256|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415345|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415346|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
416734|NCT00575367|B3|Baseline|Total|Total of all reporting groups
415257|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415258|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415259|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415260|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415261|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415262|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415263|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415264|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415265|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415266|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415347|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415348|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415349|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415267|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415268|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415269|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415270|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415271|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415272|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415273|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415274|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415275|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415276|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415350|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415351|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415352|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415277|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415278|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415279|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415280|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415281|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415282|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415283|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415284|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415285|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415286|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415353|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415354|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415355|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415287|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415288|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415289|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415290|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415291|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415292|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415293|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415294|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415295|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415296|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415356|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415357|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415358|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415297|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415298|NCT00578305|O3|Outcome|Placebo|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415299|NCT00578305|O2|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415300|NCT00578305|O1|Outcome|Rituximab 500 mg|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415301|NCT00578305|E9|Reported Event|Placebo - Safety Follow-up Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415302|NCT00578305|E8|Reported Event|Rituximab 1000 mg - Safety Follow-up Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415303|NCT00578305|E7|Reported Event|Rituximab 500 mg - Safety Follow-up Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415304|NCT00578305|E6|Reported Event|Placebo - Extension Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415305|NCT00578305|E5|Reported Event|Rituximab 1000 mg - Extension Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415306|NCT00578305|E4|Reported Event|Rituximab 500 mg - Extension Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415359|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415360|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
416735|NCT00575367|B2|Baseline|Vigamox|
415307|NCT00578305|E3|Reported Event|Placebo - Double-blind Treatment Phase|Participants received placebo intravenously (iv) on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants were switched to receive rituximab 1000 mg iv on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415308|NCT00578305|E2|Reported Event|Rituximab 1000 mg - Double-blind Treatment Phase|Participants received rituximab 1000 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415309|NCT00578305|E1|Reported Event|Rituximab 500 mg - Double-blind Treatment Phase|Participants received rituximab 500 mg iv on Day 1 and Day 15 of the main study. Participants received a second course of treatment on Day 1 and Day 15 after Week 24 of the main study, if they met eligibility criteria (see the Detailed Description). Participants received further treatment courses on Day 1 and Day 15 at intervals of ≥ 6 months after Week 52 in the study extension phase, if they met eligibility criteria (see the Detailed Description). Throughout the study, participants received methylprednisolone 100 mg iv prior to infusion of the investigational drug, methotrexate 7.5 to 25 mg/week orally or parenterally, and folic acid or folate ≥ 5 mg/week orally.
415310|NCT00578279|B3|Baseline|Total|Total of all reporting groups
415311|NCT00578279|B2|Baseline|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
415312|NCT00578279|B1|Baseline|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
415313|NCT00578279|P2|Participant Flow|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
415314|NCT00578279|P1|Participant Flow|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
415315|NCT00578279|O2|Outcome|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
415316|NCT00578279|O1|Outcome|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
415317|NCT00578279|E2|Reported Event|20 mL of Alcohol Injection|subject randomized to 20ml of dehydrated alcohol
415318|NCT00578279|E1|Reported Event|10 mL of Alcohol Injection|subject randomized to 10ml of dehydrated alcohol
415319|NCT00578227|B4|Baseline|Total|Total of all reporting groups
415320|NCT00578227|B3|Baseline|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415321|NCT00578227|B2|Baseline|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415322|NCT00578227|B1|Baseline|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415323|NCT00578227|P3|Participant Flow|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415324|NCT00578227|P2|Participant Flow|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415325|NCT00578227|P1|Participant Flow|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415326|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415327|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415328|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415329|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415330|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415331|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415332|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415333|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415334|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415335|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415336|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415337|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415338|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415339|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415340|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415341|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415342|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415343|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415344|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415544|NCT00578071|O1|Outcome|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415361|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415362|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
415363|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415364|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415365|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415366|NCT00578227|O4|Outcome|9-Year Old Cervarix Vaccine Recipients|All 9-year subjects who received 3 doses of HPV vaccine alone or co-administered with HAB vaccine.
415367|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415368|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415369|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415370|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415371|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415372|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415373|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415374|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415375|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415376|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415377|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415378|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415379|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415380|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415381|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415382|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415383|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415384|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415385|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415386|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415387|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415388|NCT00578227|O3|Outcome|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415389|NCT00578227|O2|Outcome|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415390|NCT00578227|O1|Outcome|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415391|NCT00578227|E3|Reported Event|Twinrix™ Group|Subjects received 3 doses of HAB vaccine (Months 0, 1 & 6).
415392|NCT00578227|E2|Reported Event|Cervarix™ Group|Subjects received 3 doses of HPV vaccine (Months 0, 1 & 6).
415393|NCT00578227|E1|Reported Event|Cervarix™ & Twinrix™ Group|Subjects received 3 doses of Human Papilloma Virus (HPV) vaccine co-administered with combined Hepatitis A & Hepatitis B (HAB) vaccine (Months 0, 1 & 6).
415394|NCT00578214|B4|Baseline|Total|Total of all reporting groups
415395|NCT00578214|B3|Baseline|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415396|NCT00578214|B2|Baseline|Placebo|Randomized patients receiving placebo syrup
415397|NCT00578214|B1|Baseline|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415398|NCT00578214|P3|Participant Flow|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415399|NCT00578214|P2|Participant Flow|Placebo|Randomized patients receiving placebo syrup
415400|NCT00578214|P1|Participant Flow|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415401|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415402|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415403|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415404|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415405|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415406|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415407|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415408|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415409|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415410|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415411|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415412|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415413|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415414|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415415|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415416|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415417|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415418|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415419|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415420|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415421|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415422|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415423|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415424|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415425|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415426|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415427|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415428|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415429|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415430|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415431|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415432|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415433|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415434|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415435|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415436|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415437|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415438|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415439|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415440|NCT00578214|O3|Outcome|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415441|NCT00578214|O2|Outcome|Placebo|Randomized patients receiving placebo syrup
415442|NCT00578214|O1|Outcome|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415443|NCT00578214|E3|Reported Event|Prospective Midazolam|Open-label, dose of Midazolam based on patient's weight, additional doses to control anxiety were possible
415444|NCT00578214|E2|Reported Event|Placebo|Randomized patients receiving placebo syrup
415445|NCT00578214|E1|Reported Event|Randomized Midazolam|Randomized patients receiving single-dose midazolam syrup
415446|NCT00578175|B4|Baseline|Total|Total of all reporting groups
415447|NCT00578175|B3|Baseline|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415448|NCT00578175|B2|Baseline|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415449|NCT00578175|B1|Baseline|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415450|NCT00578175|P3|Participant Flow|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415451|NCT00578175|P2|Participant Flow|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415452|NCT00578175|P1|Participant Flow|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415540|NCT00578071|P1|Participant Flow|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
416736|NCT00575367|B1|Baseline|AzaSite|
415453|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415454|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415455|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415456|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415457|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415458|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415459|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415460|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415461|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415462|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415463|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415464|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415465|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415466|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415467|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415468|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415469|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415470|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415471|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415472|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415541|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415473|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415474|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415475|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415476|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415477|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415478|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415479|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415480|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415481|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415482|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415483|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415484|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415485|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415486|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415487|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415488|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415489|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415490|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415491|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415492|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415542|NCT00578071|O1|Outcome|Arm 1 Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415493|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415494|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415495|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415496|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415497|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415498|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415499|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415500|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415501|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415502|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415503|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415504|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415505|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415506|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415507|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415508|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415509|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415510|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415511|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415512|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415513|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415514|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415515|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415516|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415517|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415518|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415519|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415520|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415521|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415522|NCT00578175|O3|Outcome|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415523|NCT00578175|O2|Outcome|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415524|NCT00578175|O1|Outcome|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415525|NCT00578175|E3|Reported Event|ProQuad® Group|Subjects received at day 0 a single dose of ProQuad® subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At day 180 they received a second dose of Havrix® intramuscularly.
415526|NCT00578175|E2|Reported Event|Freezer-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of freezer-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415527|NCT00578175|E1|Reported Event|Refrigerator-stored Priorix-Tetra™ Group|Subjects received at day 0 a single dose of refrigerator-stored Priorix-Tetra™ subcutaneously in the right upper arm co-administered with a single dose of Havrix® and Prevnar® intramuscularly in the left and right thigh respectively. At Day 180 they received a second dose of Havrix® intramuscularly in the left thigh.
415528|NCT00578136|B3|Baseline|Total|Total of all reporting groups
415529|NCT00578136|B2|Baseline|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
415530|NCT00578136|B1|Baseline|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
415531|NCT00578136|P2|Participant Flow|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
415532|NCT00578136|P1|Participant Flow|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
415533|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
415534|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
415535|NCT00578136|O2|Outcome|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
415536|NCT00578136|O1|Outcome|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
415537|NCT00578136|E2|Reported Event|Local Infiltration|2) The second group will receive local anesthetic infiltration of the surgical site at the end the umbilical hernia repair.
415538|NCT00578136|E1|Reported Event|Rectus Sheath Block|1) One group will receive the rectus sheath block prior to Umbilical hernia repair.
415539|NCT00578071|B1|Baseline|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415545|NCT00578071|E1|Reported Event|Chemoradiation|Panitumumab, oxiplatin, capecitabine, radiation therapy
415546|NCT00577889|B4|Baseline|Total|Total of all reporting groups
415547|NCT00577889|B3|Baseline|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415548|NCT00577889|B2|Baseline|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415549|NCT00577889|B1|Baseline|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415550|NCT00577889|P3|Participant Flow|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415551|NCT00577889|P2|Participant Flow|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415552|NCT00577889|P1|Participant Flow|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415553|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415554|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415555|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415556|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415557|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415558|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415559|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415560|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415561|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415562|NCT00577889|O3|Outcome|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415563|NCT00577889|O2|Outcome|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415598|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415599|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
416737|NCT00575367|P2|Participant Flow|Vigamox|
415564|NCT00577889|O1|Outcome|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415565|NCT00577889|E3|Reported Event|Arm III (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on day 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 1 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415566|NCT00577889|E2|Reported Event|Arm II (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on days 2 and 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415567|NCT00577889|E1|Reported Event|Arm I (Combination Chemotherapy)|Patients receive 750 mg/m2 gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and 154 mg/m2 tanespimycin IV over 1 hour on day 9 of course one. Beginning with course two (and for all subsequent courses), all patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and tanespimycin IV over 1 hour on days 2 and 9.
415568|NCT00577863|B3|Baseline|Total|Total of all reporting groups
415569|NCT00577863|B2|Baseline|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
415570|NCT00577863|B1|Baseline|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
415571|NCT00577863|P2|Participant Flow|Not Current Users|A Not Current User could be either treatment naïve or have experience with the original device (Forteo 1.1 Pen) that did not meet the criteria outlined for a Current User. Thus, a Not Current User could have used the original delivery device for up to 22 months, as long as they had not used the original device within 4 weeks of enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
415572|NCT00577863|P1|Participant Flow|Current Users|A Current User was defined as a patient with ≥8 weeks experience with the original delivery device (Forteo 1.1 Pen), including uninterrupted use during the 4 weeks prior to enrollment. Patients received teriparatide 20 mcg/day during the study using the Forteo B Pen.
415573|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
415574|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
415575|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415576|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415577|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415578|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415579|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415580|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415581|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415582|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415583|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415584|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415585|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415586|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415587|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415588|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415589|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415590|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415591|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415592|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415593|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415594|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415595|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415596|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415597|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
416738|NCT00575367|P1|Participant Flow|AzaSite|
415600|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415601|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415602|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415603|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415604|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415605|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 46 weeks.
415606|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415607|NCT00577863|O1|Outcome|Forteo 1.1 Pen Users|Current users of the Forteo 1.1 Pen.
415608|NCT00577863|O1|Outcome|Forteo B Pen Users|All subjects using the Forteo B Pen to self-administer teriparatide in the community setting for 8 weeks.
415609|NCT00577863|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms per day
415610|NCT00577824|B4|Baseline|Total|Total of all reporting groups
415611|NCT00577824|B3|Baseline|Placebo BID|placebo SC, twice daily
415612|NCT00577824|B2|Baseline|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415613|NCT00577824|B1|Baseline|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415614|NCT00577824|P3|Participant Flow|Placebo BID|placebo SC, twice daily
415615|NCT00577824|P2|Participant Flow|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415616|NCT00577824|P1|Participant Flow|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415617|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415618|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415619|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415620|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415621|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415622|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415623|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415624|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415625|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415626|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415627|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415628|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415629|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415630|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415631|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415632|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415633|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415634|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415635|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415636|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415637|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415638|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415639|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415640|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415641|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415642|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415643|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415644|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415645|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415646|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415647|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415648|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415649|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415650|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415651|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415652|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415653|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415654|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415655|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415656|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415657|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415658|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415659|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415660|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415661|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415662|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415663|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415664|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415665|NCT00577824|O3|Outcome|Placebo BID|placebo SC, twice daily
415666|NCT00577824|O2|Outcome|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415667|NCT00577824|O1|Outcome|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415668|NCT00577824|E3|Reported Event|Placebo BID|placebo SC, twice daily
415669|NCT00577824|E2|Reported Event|10mcg Exenatide BID|exenatide SC 10mcg, twice daily
415670|NCT00577824|E1|Reported Event|5mcg Exenatide BID|exenatide SC 5mcg, twice daily
415671|NCT00577772|B3|Baseline|Total|Total of all reporting groups
415694|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415695|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
416739|NCT00575367|O2|Outcome|Vigamox|
415672|NCT00577772|B2|Baseline|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
415673|NCT00577772|B1|Baseline|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
415674|NCT00577772|P2|Participant Flow|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
415675|NCT00577772|P1|Participant Flow|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the SmartPill Capsule 5 days later.
415676|NCT00577772|O2|Outcome|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
415677|NCT00577772|O1|Outcome|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
415678|NCT00577772|E2|Reported Event|Symptomatic Participants|"Subjects with symptoms suggestive of small bowel bacterial overgrowth (SBBO) (e.g., diarrhea, bloating, abdominal discomfort) for at least 3 months will be divided into 2 groups based on the results of their previous testing for SBBO (5 SBBO positive patients, 5 SBBO negative patients).~The symptomatic participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.~After the capsule has been demonstrated to be passed from the subject, the subjects with SBBO present will then enter into an open-label treatment using Rifaximin (400 mg PO TID) for 7 days."
415679|NCT00577772|E1|Reported Event|Healthy Participants|Healthy Participants will report for simultaneous lactulose hydrogen breath test (H_2BT) and SmartPill study after an overnight fast. They will swallow the SmartPill Capsule at the study site. After 4 hours, they will be allowed to leave the study site and consume their usual diet. They will return for removal of the data recorder 5 days later.
415680|NCT00577720|B5|Baseline|Total|Total of all reporting groups
415681|NCT00577720|B4|Baseline|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415682|NCT00577720|B3|Baseline|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415683|NCT00577720|B2|Baseline|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415684|NCT00577720|B1|Baseline|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415685|NCT00577720|P4|Participant Flow|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415686|NCT00577720|P3|Participant Flow|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415687|NCT00577720|P2|Participant Flow|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415688|NCT00577720|P1|Participant Flow|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415689|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415690|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415691|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415692|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415693|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415696|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415697|NCT00577720|O4|Outcome|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415698|NCT00577720|O3|Outcome|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415699|NCT00577720|O2|Outcome|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415700|NCT00577720|O1|Outcome|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415701|NCT00577720|E4|Reported Event|50 mg DRBB (Delayed Release Before Breakfast)|50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415702|NCT00577720|E3|Reported Event|50 mg DRFB|50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415703|NCT00577720|E2|Reported Event|35 mg DRFB (Delayed Release Following Breakfast)|35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks
415704|NCT00577720|E1|Reported Event|35 mg IRBB (Immediate Release Before Breakfast)|35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks
415705|NCT00577707|B1|Baseline|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
415706|NCT00577707|P1|Participant Flow|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
415707|NCT00577707|O1|Outcome|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
415708|NCT00577707|E1|Reported Event|Patients With Stage IB-IIIA NSCLC With EGFR Mutations|Phase II Study of Erlotinib and Chemotherapy for Patients with Stage IB-IIIA NSCLC with EGFR Mutations
415709|NCT00577655|B3|Baseline|Total|Total of all reporting groups
415710|NCT00577655|B2|Baseline|Placebo|Placebo HFA-MDI four times a day for 21 days.
415711|NCT00577655|B1|Baseline|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415712|NCT00577655|P2|Participant Flow|Placebo|Placebo HFA-MDI four times a day for 21 days.
415713|NCT00577655|P1|Participant Flow|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415714|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415715|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415716|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415717|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415718|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415719|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415720|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415721|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415722|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415723|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415724|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415725|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415726|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415727|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415728|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415729|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415730|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415731|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415732|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415733|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415734|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
415735|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415736|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415737|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415738|NCT00577655|O2|Outcome|Placebo|Placebo HFA-MDI four times a day for 21 days.
415739|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415740|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
415741|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415742|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
415743|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415744|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
415745|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415746|NCT00577655|O2|Outcome|Placebo|Placebo-HFA-MDI four times a day for 21 days.
415747|NCT00577655|O1|Outcome|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day (total daily albuterol dose of 720 mcg) for 21 days.
415748|NCT00577655|E2|Reported Event|Placebo|Placebo HFA-MDI four times a day for 21 days.
415749|NCT00577655|E1|Reported Event|Albuterol|Albuterol-HFA-MDI 180 mcg, four times a day
415750|NCT00577629|B1|Baseline|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
415751|NCT00577629|P1|Participant Flow|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
415752|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar)
415753|NCT00577629|O1|Outcome|Experimental: Induction + Consolidation + Bexxar|Induction: Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation: Cytarabine and Doxorubicin followed by radioimmunotherapy: Bexxar
415754|NCT00577629|E1|Reported Event|All Subjects|Induction:Cyclophosphamide, Etoposide, and Rituxan followed by Consolidation:Cytarabine and Doxorubicin followed by radioimmunotherapy:Bexxar
415755|NCT00577512|B1|Baseline|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
415756|NCT00577512|P1|Participant Flow|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
415757|NCT00577512|O1|Outcome|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
415758|NCT00577512|E1|Reported Event|HD DTPACE|"High dose DTPACE and stem cell collection if you do not already have sufficient stem cells stored~High dose DTPACE and stem cell re-infusion~VTD Maintenance therapy"
415759|NCT00577473|B3|Baseline|Total|Total of all reporting groups
415760|NCT00577473|B2|Baseline|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415761|NCT00577473|B1|Baseline|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415762|NCT00577473|P2|Participant Flow|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415763|NCT00577473|P1|Participant Flow|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415764|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415765|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415766|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415767|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415768|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415769|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415770|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415771|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415772|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415773|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415774|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415775|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415776|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415777|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415778|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415779|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415780|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415781|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415782|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415783|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415784|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415785|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415786|NCT00577473|O2|Outcome|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415787|NCT00577473|O1|Outcome|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415788|NCT00577473|E2|Reported Event|Asacol 4.8 g/Day|2 - 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg tablet) 3 times daily for 6 weeks
415789|NCT00577473|E1|Reported Event|Asacol 2.4 g/Day|2 - 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg Asacol tablet) 3 times daily for 6 weeks
415790|NCT00577460|B4|Baseline|Total|Total of all reporting groups
415791|NCT00577460|B3|Baseline|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415907|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
415792|NCT00577460|B2|Baseline|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415793|NCT00577460|B1|Baseline|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415794|NCT00577460|P3|Participant Flow|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole Immediate Release (IR) in previous trial
415795|NCT00577460|P2|Participant Flow|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415796|NCT00577460|P1|Participant Flow|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415797|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415798|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415799|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415800|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415801|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415802|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415803|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415804|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415805|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415806|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415807|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415808|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415809|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415810|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415811|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415812|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415813|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415814|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415815|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415816|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415817|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415818|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415819|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415820|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415821|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415822|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415823|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415824|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415825|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415826|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415827|NCT00577460|O3|Outcome|PPX IR|Treatment with Pramipexole IR in previous trial
415828|NCT00577460|O2|Outcome|PPX ER|Treatment with Pramipexole ER in previous trial
415829|NCT00577460|O1|Outcome|Placebo|Treatment with matching placebo in previous trial (NCT00466167)
415830|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415831|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415832|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415833|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415834|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415835|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415836|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415837|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415838|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415839|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415840|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415841|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415842|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415843|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415844|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415845|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415846|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415847|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415848|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415849|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415850|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415851|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415852|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415853|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415854|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415855|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415856|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415857|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415858|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415859|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415860|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415861|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415862|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415863|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415864|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415865|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415866|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415867|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415868|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415869|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415870|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415871|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415872|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415873|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415874|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415875|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415876|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415877|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415878|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415879|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415880|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415881|NCT00577460|O4|Outcome|Total PPX ER|Pramipexole ER, all patients
415882|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415883|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415884|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415885|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415886|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415887|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415888|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415889|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415890|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415891|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415892|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415893|NCT00577460|O3|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415894|NCT00577460|O2|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415895|NCT00577460|O1|Outcome|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415896|NCT00577460|O2|Outcome|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415897|NCT00577460|O1|Outcome|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415898|NCT00577460|E4|Reported Event|Total PPX ER|Pramipexole ER, all patients
415899|NCT00577460|E3|Reported Event|PPX ER (Previous PPX IR)|Pramipexole ER Treatment with Pramipexole IR in previous trial
415900|NCT00577460|E2|Reported Event|PPX ER (Previous PPX ER)|Pramipexole ER Treatment with Pramipexole ER in previous trial
415901|NCT00577460|E1|Reported Event|PPX ER (Previous Placebo)|Pramipexole ER Treatment with placebo in previous trial
415902|NCT00577395|B3|Baseline|Total|Total of all reporting groups
415903|NCT00577395|B2|Baseline|Placebo Tablet Once a Month|Placebo tablet once a month, orally
415904|NCT00577395|B1|Baseline|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
415905|NCT00577395|P2|Participant Flow|Placebo Tablet Once a Month|Placebo tablet once a month, orally
415906|NCT00577395|P1|Participant Flow|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
415908|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
415909|NCT00577395|O2|Outcome|Placebo Tablet Once a Month|Placebo tablet once a month, orally
415910|NCT00577395|O1|Outcome|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
415911|NCT00577395|E2|Reported Event|Placebo Tablet Once a Month|Placebo tablet once a month, orally
415912|NCT00577395|E1|Reported Event|One 150 mg Risedronate Once a Month|one 150 mg risedronate once a month, orally
415913|NCT00577382|B3|Baseline|Total|Total of all reporting groups
415914|NCT00577382|B2|Baseline|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415915|NCT00577382|B1|Baseline|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415916|NCT00577382|P2|Participant Flow|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415917|NCT00577382|P1|Participant Flow|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415918|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415919|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415920|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415921|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415922|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415923|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415924|NCT00577382|O2|Outcome|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415925|NCT00577382|O1|Outcome|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415926|NCT00577382|E2|Reported Event|Cohort B-Sunitinib Continuous Dosing|Cohort B participants received 37.5 mg sunitinib daily on a continuous basis until progression or unacceptable toxicity up to 1 year.
415927|NCT00577382|E1|Reported Event|Cohort A-Sunitinib Intermittent Dosing|Cohort A participants received 50 mg sunitinib orally daily for 4 weeks followed by a two-week break from treatment. These 6-week cycles would be repeated until progression or unacceptable toxicity up to 1 year.
415928|NCT00577356|B1|Baseline|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
415929|NCT00577356|P1|Participant Flow|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
415930|NCT00577356|O1|Outcome|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
415931|NCT00577356|E1|Reported Event|CG1940/CG8711 (Immunotherapy Drug)|Patients were given a prime immunotherapy of 5 x 108 cells consisting of equal amounts of CG1940 and CG8711 followed 21 days later by boost immunotherapies of 3 x 108 cells consisting of equal amounts of CG1940 and CG8711 every 21 days for the first 4 immunotherapies. (given 2 to 3 days after docetaxel) for a total of 4 immunotherapies, followed by a fifth dose given at 2, 8, or 14 days prior to prostatectomy, and then beginning at 3 – 6 weeks post-operatively an additional 6 immunotherapies every 14 days for a combined total of 11 immunotherapies. Docetaxel chemotherapy was administered intravenously starting day 1 of the first week and given every 3 weeks thereafter for a total of 4 cycles. A cycle is defined as every 21 days (3 weeks).
416740|NCT00575367|O1|Outcome|AzaSite|
415937|NCT00577135|P4|Participant Flow|Continuous Infusion & High Intensification|High intensification (2.5 x oral dose) IV furosemide by continuous infusion
415938|NCT00577135|P3|Participant Flow|Continuous Infusion & Low Intensification|Low intensification (1 x oral dose) IV furosemide by continuous infusion
415939|NCT00577135|P2|Participant Flow|Q12 Hours Bolus & High Intensification|High intensification (2.5 x oral dose) IV furosemide by Q12 hours bolus
415940|NCT00577135|P1|Participant Flow|Q12 Hours Bolus & Low Intensification|Low intensification (1 x oral dose) IV furosemide by Q12 hours bolus
415941|NCT00577135|O4|Outcome|High Intensification|
415942|NCT00577135|O3|Outcome|Low Intensification|
415943|NCT00577135|O2|Outcome|Continuous Infusion|
415944|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415945|NCT00577135|O4|Outcome|High Intensification|
415946|NCT00577135|O3|Outcome|Low Intensification|
415947|NCT00577135|O2|Outcome|Continuous Infusion|
415948|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415949|NCT00577135|O4|Outcome|High Intensification|
415950|NCT00577135|O3|Outcome|Low Intensification|
415951|NCT00577135|O2|Outcome|Continuous Infusion|
415952|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415953|NCT00577135|O4|Outcome|High Intensification|
415954|NCT00577135|O3|Outcome|Low Intensification|
415955|NCT00577135|O2|Outcome|Continuous Infusion|
415956|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415957|NCT00577135|O4|Outcome|High Intensification|
415958|NCT00577135|O3|Outcome|Low Intensification|
415959|NCT00577135|O2|Outcome|Continuous Infusion|
415960|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415961|NCT00577135|O4|Outcome|High Intensification|
415962|NCT00577135|O3|Outcome|Low Intensification|
415963|NCT00577135|O2|Outcome|Continuous Infusion|
415964|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415965|NCT00577135|O4|Outcome|High Intensification|
415966|NCT00577135|O3|Outcome|Low Intensification|
415967|NCT00577135|O2|Outcome|Continuous Infusion|
415968|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415969|NCT00577135|O4|Outcome|High Intensification|
415970|NCT00577135|O3|Outcome|Low Intensification|
415971|NCT00577135|O2|Outcome|Continuous Infusion|
415972|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415973|NCT00577135|O4|Outcome|High Intensification|
415974|NCT00577135|O3|Outcome|Low Intensification|
415975|NCT00577135|O2|Outcome|Continuous Infusion|
415976|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415977|NCT00577135|O4|Outcome|High Intensification|
415978|NCT00577135|O3|Outcome|Low Intensification|
415979|NCT00577135|O2|Outcome|Continuous Infusion|
415980|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415981|NCT00577135|O4|Outcome|High Intensification|
415982|NCT00577135|O3|Outcome|Low Intensification|
415983|NCT00577135|O2|Outcome|Continuous Infusion|
415984|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415985|NCT00577135|O4|Outcome|High Intensification|
415986|NCT00577135|O3|Outcome|Low Intensification|
415987|NCT00577135|O2|Outcome|Continuous Infusion|
415988|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415989|NCT00577135|O4|Outcome|High Intensification|
415990|NCT00577135|O3|Outcome|Low Intensification|
415991|NCT00577135|O2|Outcome|Continuous Infusion|
415992|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415993|NCT00577135|O4|Outcome|High Intensification|
415994|NCT00577135|O3|Outcome|Low Intensification|
415995|NCT00577135|O2|Outcome|Continuous Infusion|
415996|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
415997|NCT00577135|O4|Outcome|High Intensification|
415998|NCT00577135|O3|Outcome|Low Intensification|
415999|NCT00577135|O2|Outcome|Continuous Infusion|
416000|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416001|NCT00577135|O4|Outcome|High Intensification|
416002|NCT00577135|O3|Outcome|Low Intensification|
416003|NCT00577135|O2|Outcome|Continuous Infusion|
416004|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416005|NCT00577135|O4|Outcome|High Intensification|
416006|NCT00577135|O3|Outcome|Low Intensification|
416007|NCT00577135|O2|Outcome|Continuous Infusion|
416008|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416009|NCT00577135|O4|Outcome|High Intensification|
416010|NCT00577135|O3|Outcome|Low Intensification|
416011|NCT00577135|O2|Outcome|Continuous Infusion|
416012|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416013|NCT00577135|O4|Outcome|High Intensification|
416014|NCT00577135|O3|Outcome|Low Intensification|
416015|NCT00577135|O2|Outcome|Continuous Infusion|
416016|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416017|NCT00577135|O4|Outcome|High Intensification|
416018|NCT00577135|O3|Outcome|Low Intensification|
416019|NCT00577135|O2|Outcome|Continuous Infusion|
416020|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416021|NCT00577135|O4|Outcome|High Intensification|
416022|NCT00577135|O3|Outcome|Low Intensification|
416023|NCT00577135|O2|Outcome|Continuous Infusion|
416024|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416025|NCT00577135|O4|Outcome|High Intensification|
416026|NCT00577135|O3|Outcome|Low Intensification|
416027|NCT00577135|O2|Outcome|Continuous Infusion|
416028|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416029|NCT00577135|O4|Outcome|High Intensification|
416030|NCT00577135|O3|Outcome|Low Intensification|
416031|NCT00577135|O2|Outcome|Continuous Infusion|
416032|NCT00577135|O1|Outcome|Q 12 Hour Bolus|
416033|NCT00577135|O4|Outcome|High Intensification|
416034|NCT00577135|O3|Outcome|Low Intensification|
416035|NCT00577135|O2|Outcome|Continuous Infusion|
416058|NCT00577122|B2|Baseline|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416059|NCT00577122|B1|Baseline|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416060|NCT00577122|P2|Participant Flow|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416061|NCT00577122|P1|Participant Flow|Cohort 1: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416062|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416063|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416064|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416065|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416066|NCT00577122|O2|Outcome|Cohort II: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416067|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416068|NCT00577122|O2|Outcome|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416069|NCT00577122|O1|Outcome|Cohort I: MPA-Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416070|NCT00577122|E2|Reported Event|Cohort 2: MPA+IdoCM|"Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.~Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week."
416071|NCT00577122|E1|Reported Event|Cohort 1: MPA Alone|Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
416072|NCT00577096|B3|Baseline|Total|Total of all reporting groups
416073|NCT00577096|B2|Baseline|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416074|NCT00577096|B1|Baseline|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416075|NCT00577096|P2|Participant Flow|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416076|NCT00577096|P1|Participant Flow|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416132|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416077|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416078|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416079|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416080|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416081|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416082|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416083|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416112|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416084|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416085|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416086|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416087|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416088|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416089|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416090|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416113|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416091|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416092|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416093|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416094|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416095|NCT00577096|O2|Outcome|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416096|NCT00577096|O1|Outcome|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416097|NCT00577096|E2|Reported Event|Exercise|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were computer randomized to an individualized exercise program that incorporated aerobic and strength resistance training. Participants were stratified by thalidomide administration and by age (<=60 versus >60). Participants who received thalidomide also received low-molecular weight heparin.
416114|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416098|NCT00577096|E1|Reported Event|Usual Care|Participants received standard care for multiple myeloma which included: For the Short term study: Total Therapy II Chemotherapy Regimen (See Protocol) and Stem Cell Harvest. For the Long term study: Total Therapy II Chemotherapy Regimen (See Protocol) and melphalan with autologous peripheral-blood stem cell transplantation (PBSCT). For both the short and long term studies, red blood cell (RBC) and platelet transfusions were administered as needed, in addition to Epoetic Alfa (EPO) when hemoglobin levels dropped during high dose chemotherapy. The usual EPO dose is 150 units/kg of body weight, three times per week, or 40,000 units weekly, with suggested target hemoglobin range of 10-12 g/dl. Study participants were asked to remain as active as possible but not prescribed an individualized exercise program. Participants were stratified by thalidomide administration and by age (<=60 versus >60).Participants who received thalidomide also received low-molecular weight heparin
416099|NCT00577083|B3|Baseline|Total|Total of all reporting groups
416100|NCT00577083|B2|Baseline|Initial Cap-fitted First Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416101|NCT00577083|B1|Baseline|No Cap First, Then Cap Fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416102|NCT00577083|P2|Participant Flow|Initial Cap-fitted First, Then No Cap|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416103|NCT00577083|P1|Participant Flow|No Cap First, Then Cap-fitted|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416104|NCT00577083|O2|Outcome|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416105|NCT00577083|O1|Outcome|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416106|NCT00577083|E2|Reported Event|Initial Cap-fitted|"Initial cap-fitted colonoscopy for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416107|NCT00577083|E1|Reported Event|Initial Regular|"no cap on the end of the colonoscope for the first insertion~Cap-fitted colonoscopy: Subjects will be randomized to either initial cap-fitted colonoscopy or regular colonoscopy. Patients in the initial regular arm, will undergo cap-fitted colonoscopy for their second, tandem examination. Patients in the initial cap-fitted arm, will under undergo regular colonoscopy (without the cap) for their second, tandem examination."
416108|NCT00577031|B1|Baseline|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416109|NCT00577031|P1|Participant Flow|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) and oxaliplatin 130 mg per square meter (mg/m^2) IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416110|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416111|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416131|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416115|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416116|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416117|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416118|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416119|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416120|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416121|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416122|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles):~Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day~1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles):~If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416123|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416124|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV and oxaliplatin 130 mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416125|NCT00577031|O1|Outcome|Bevucizamab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416126|NCT00577031|E1|Reported Event|Bevacizumab+Oxaliplatin+Capecitabine/Bevacizumab|"Cycles 1-8 (3-week cycles): Participants received bevacizumab 7.5 mg/kg IV) and oxaliplatin 130 mg mg/m^2 IV on Day 1 and capecitabine 1000 mg/m^2 tablets, orally, every 12 hours starting the evening of Day 1 for 14 days continuously; cycle was repeated until disease progression or for a maximum of 8 cycles.~Cycle 9 and beyond (3-week cycles): If the first 8 cycles were tolerated with no disease progression, participants received bevacizumab 7.5 mg/kg IV on Day 1; the cycle was repeated until disease progression."
416127|NCT00576927|B3|Baseline|Total|Total of all reporting groups
416128|NCT00576927|B2|Baseline|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416129|NCT00576927|B1|Baseline|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416130|NCT00576927|P1|Participant Flow|All Subjects|
416133|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416134|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416135|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416136|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416137|NCT00576927|O2|Outcome|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416138|NCT00576927|O1|Outcome|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416139|NCT00576927|E2|Reported Event|Placebo|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Placebo for those whose sleep did not improve with SHI alone.
416140|NCT00576927|E1|Reported Event|Ramelteon|6 Weeks of Sleep Hygiene Intervention (SHI) followed by Placebo Run-in (3 days) then Active Drug (Ramelteon) for those whose sleep did not improve.
416141|NCT00576901|B1|Baseline|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416142|NCT00576901|P1|Participant Flow|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1; docetaxel 75 mg per square meter (mg/m^2), IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416143|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416144|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416145|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416146|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416147|NCT00576901|O1|Outcome|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416148|NCT00576901|E1|Reported Event|Bevacizumab+Docetaxel+Capecitabine|Participants received bevacizumab 15 mg/kg, IV, on Day 1; docetaxel 75 mg/m^2, IV, on Day 1; and capecitabine 2000 mg/m^2, orally, on Days 1-15. This cycle was repeated every 3 weeks for a total of 4 cycles. If all 4 cycles were tolerated, participants then completed an additional 2 cycles, for a maximum of 6 cycles of study treatment.
416149|NCT00576823|B4|Baseline|Total|Total of all reporting groups
416150|NCT00576823|B3|Baseline|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
416151|NCT00576823|B2|Baseline|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
416152|NCT00576823|B1|Baseline|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
416153|NCT00576823|P3|Participant Flow|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
416154|NCT00576823|P2|Participant Flow|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
416155|NCT00576823|P1|Participant Flow|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
416156|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
416157|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
416158|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
416159|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|
416160|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|
416161|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|
416162|NCT00576823|O3|Outcome|Alfuzosin Tablet - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
416230|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416163|NCT00576823|O2|Outcome|Alfuzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
416164|NCT00576823|O1|Outcome|Alfuzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
416165|NCT00576823|E3|Reported Event|Afluzosin Tablets - 8-16 Years|Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow the tablets and had a body weight ≥ 30 kg.
416166|NCT00576823|E2|Reported Event|Afluzosin Solution - 8-16 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow the tablets or preferred to take the solution or had a body weight < 30 kg.
416167|NCT00576823|E1|Reported Event|Afluzosin Solution - 2-7 Years|Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
416168|NCT00576758|B3|Baseline|Total|Total of all reporting groups
416169|NCT00576758|B2|Baseline|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416170|NCT00576758|B1|Baseline|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416171|NCT00576758|P2|Participant Flow|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416172|NCT00576758|P1|Participant Flow|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416173|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416174|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416175|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416176|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416177|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416178|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416179|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416180|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416181|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416182|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416183|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416184|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416185|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416186|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416187|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416188|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416189|NCT00576758|O1|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416190|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416191|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416192|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416193|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416194|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416231|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416232|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416314|NCT00576472|B2|Baseline|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
416195|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416196|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416197|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416198|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416199|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416200|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416201|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416202|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416203|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416204|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416205|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416206|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416207|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416208|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416233|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416234|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416209|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416210|NCT00576758|O2|Outcome|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416211|NCT00576758|O1|Outcome|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416212|NCT00576758|E2|Reported Event|Obinutuzumab|Participants received 1000 mg obinutuzumab intravenous (IV) infusion once a week on Days 1, 8, 15, and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression, were eligible to receive a 1000 mg IV infusion every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416213|NCT00576758|E1|Reported Event|Rituximab|Participants received 375 mg/m^2 rituximab IV infusion once a week on Days 1, 8, 15 and 22 in the Induction Period. 2 months following the last infusion, participants without disease progression were eligible to receive a 375 mg/m^2 rituximab IV infusion once every two months for 2 years in the Extension Period. All participants received oral acetaminophen/ paracetamol (1000 mg) and an antihistamine such as diphenhydramine (50-100 mg), 30-60 minutes prior to each infusion.
416214|NCT00576732|B4|Baseline|Total|Total of all reporting groups
416215|NCT00576732|B3|Baseline|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416216|NCT00576732|B2|Baseline|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416217|NCT00576732|B1|Baseline|Placebo|Double-blind Period. Oral solution for 6 weeks.
416218|NCT00576732|P6|Participant Flow|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416219|NCT00576732|P5|Participant Flow|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416220|NCT00576732|P4|Participant Flow|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416221|NCT00576732|P3|Participant Flow|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416222|NCT00576732|P2|Participant Flow|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416223|NCT00576732|P1|Participant Flow|Placebo|Double-blind Period. Oral solution for 6 weeks.
416224|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416225|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416226|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416227|NCT00576732|O3|Outcome|Ris High Dose/RIS|Open-label Period. Subjects in the double-blind risperidone high dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416228|NCT00576732|O2|Outcome|Ris Low Dose/RIS|Open-label Period. Subjects in the double-blind risperidone low dose group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416229|NCT00576732|O1|Outcome|Placebo/RIS|Open-label Period. Subjects in the double-blind placebo group who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416235|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416236|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416237|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416238|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416239|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416240|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416241|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416242|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416243|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416244|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416245|NCT00576732|O3|Outcome|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416246|NCT00576732|O2|Outcome|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416247|NCT00576732|O1|Outcome|Placebo|Double-blind Period. Oral solution for 6 weeks.
416248|NCT00576732|E4|Reported Event|Open-label Risperidone|Subjects who continued into open-label risperidone period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 3 days, 0.25 mg tablet on Day 4, flexible dose in 0.25 mg or 0.5 mg increments every 2 weeks, as clinically indicated, to a maximum dose of 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg).
416249|NCT00576732|E3|Reported Event|Risperidone High Dose|Double-blind Period. Risperidone oral solution 1.25 mg (if <45 kg) or 1.75 mg (if >=45 kg) for 6 weeks.
416250|NCT00576732|E2|Reported Event|Risperidone Low Dose|Double-blind Period. Risperidone oral solution 0.125 mg (if <45 kg) or 0.175 mg (if >=45 kg) for 6 weeks.
416251|NCT00576732|E1|Reported Event|Placebo|Double-blind Period. Oral solution for 6 weeks.
416252|NCT00576693|B3|Baseline|Total|Total of all reporting groups
416253|NCT00576693|B2|Baseline|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
416254|NCT00576693|B1|Baseline|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
416255|NCT00576693|P2|Participant Flow|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
416256|NCT00576693|P1|Participant Flow|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
416257|NCT00576693|O2|Outcome|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
416274|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416315|NCT00576472|B1|Baseline|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
416258|NCT00576693|O1|Outcome|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
416259|NCT00576693|E2|Reported Event|Intensive Medical Management Alone|"Intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)~intensive medical management: intensive medical therapy alone (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl)"
416260|NCT00576693|E1|Reported Event|Intensive Medical Management Plus Stenting|"intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardiac indication, and aggressive risk factor management primarily targeting blood pressure < 140 / 90 mm Hg (< 130 / 80 if diabetic) and LDL < 70 mg / dl).~intracranial angioplasty and stenting: intracranial angioplasty and stenting using the Gateway balloon and Wingspan self-expanding nitinol stent (or any future FDA approved iterations of the balloon, stent, or the delivery systems) plus intensive medical therapy (aspirin 325 mg / day for entire follow-up, clopidogrel 75mg per day for 90 days after enrollment unless cardiologist recommends continuing clopidogrel beyond 90 days for a cardia"
416261|NCT00576628|B1|Baseline|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416262|NCT00576628|P1|Participant Flow|C.E.R.A|Participants received methoxy polyethylene glycol-epoetin beta (Continuous Erythropoietin Receptor Activator [C.E.R.A]) subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 microgram per kilogram (mcg/kg) of C.E.R.A. Once the Hemoglobin (Hb) concentration was attained within the target range of 11.0 and 13.0 gram per deciliter (g/dL), the dose was adjusted to maintain the Hb concentration within the target range.
416263|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416264|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416265|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416266|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416267|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416268|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416269|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416270|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416271|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416272|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416273|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416313|NCT00576472|B3|Baseline|High|Intensity of prior Central Nervous System radiation therapy was considered high.
416275|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range..
416276|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416277|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416278|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416279|NCT00576628|O1|Outcome|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416280|NCT00576628|E1|Reported Event|C.E.R.A|Participants received C.E.R.A subcutaneously every four weeks for 44 weeks. The participants received initial dose of 1.2 mcg/kg of C.E.R.A. Once the Hb concentration was attained within the target range of 11.0 and 13.0 g/dL, the dose was adjusted to maintain the Hb concentration within the target range.
416281|NCT00576576|B1|Baseline|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416282|NCT00576576|P1|Participant Flow|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416283|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416284|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416285|NCT00576576|O1|Outcome|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416286|NCT00576576|E1|Reported Event|Atorvastatin|"All patients in this arm are given atorvastatin therapy.~Atorvastatin : Atorvastatin 80 mg a day"
416287|NCT00576524|B3|Baseline|Total|Total of all reporting groups
416288|NCT00576524|B2|Baseline|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
416289|NCT00576524|B1|Baseline|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
416290|NCT00576524|P2|Participant Flow|Sham Device First, ITD Next|A group of subjects will be randomized to receive sham first, followed by ITD 7 days later.
416291|NCT00576524|P1|Participant Flow|ITD First, Sham Device Next|A group of subjects will be randomized to receive the ITD first, followed by sham 7 days later.
416292|NCT00576524|O2|Outcome|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
416293|NCT00576524|O1|Outcome|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
416294|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device 7 days later.
416295|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, follwed by ITD 7 days later.
416296|NCT00576524|O2|Outcome|ITD First, Sham Device Next|A group of subjects will be randomized to receive ITD, followed by sham device after 7 days.
416297|NCT00576524|O1|Outcome|Sham Device First, ITD Next|A group of subjects will be randomized to receive the sham device, followed by ITD next after 7 days.
416298|NCT00576524|E2|Reported Event|ITD Device|A group of subjects will be randomized to receive Impedance Threshold Device.
416299|NCT00576524|E1|Reported Event|Sham Device|A group of subjects will be randomized to receive the placebo sham device.
416300|NCT00576472|B16|Baseline|Total|Total of all reporting groups
416301|NCT00576472|B15|Baseline|Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the duration of the Home Maintenance Phase.
416302|NCT00576472|B14|Baseline|Declined Home Maintenance Phase|Patients who completed the MPH Cross Over Phase but chose to decline participation in the Home Maintenance Phase.
416303|NCT00576472|B13|Baseline|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
416304|NCT00576472|B12|Baseline|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
416305|NCT00576472|B11|Baseline|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
416306|NCT00576472|B10|Baseline|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
416307|NCT00576472|B9|Baseline|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a lose dose of Methylphenidate (MPH) on week three.
416308|NCT00576472|B8|Baseline|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
416309|NCT00576472|B7|Baseline|Not Randomized-Cross Over|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross Over Phase
416310|NCT00576472|B6|Baseline|Group P/M|Group P/M (patients receive oral placebo and ten Methylphenidate (MPH))
416311|NCT00576472|B5|Baseline|Group M/P|Group M/P (patients receive oral Methylphenidate (MPH) and then an oral placebo)
416312|NCT00576472|B4|Baseline|Not Randomized-In Lab Phase|Patients not randomized for the MPH in Lab Phase
416316|NCT00576472|P15|Participant Flow|Methylphenidate (MPH) Home Maintenance Phase|Methylphenidate (MPH) was administered for 12 months during the Methylphenidate (MPH) Home Maintenance Phase.
416317|NCT00576472|P14|Participant Flow|Declined Methylphenidate (MPH) Home Maintenance Phase|Patients who completed the Methylphenidate (MPH) Cross Over Phase but chose to decline participation in the Methylphenidate (MPH) Home Maintenance Phase.
416318|NCT00576472|P13|Participant Flow|Moderate Dose/Placebo/Low Dose (MPL)|The MPL group received a moderate dose of Methylphenidate (MPH) on week one, a placebo on week two, and a low dose of Methylphenidate (MPH) on week three.
416319|NCT00576472|P12|Participant Flow|Moderate Dose/Low Dose/Placebo (MLP)|The MLP group received a moderate dose of Methylphenidate (MPH) on week one, a low dose of Methylphenidate (MPH) on week two, and a placebo on week three.
416320|NCT00576472|P11|Participant Flow|Low Dose/Placebo/Moderate Dose (LPM)|The LPM group received a low dose of Methylphenidate (MPH) on week one, a placebo on week two, and a moderate dose of Methylphenidate (MPH) on week three.
416321|NCT00576472|P10|Participant Flow|Low Dose/Moderate Dose/ Placebo (LMP)|The LMP group received a low dose of Methylphenidate (MPH) on week one, a moderate dose of Methylphenidate (MPH) on week two, and a placebo on week three.
416322|NCT00576472|P9|Participant Flow|Placebo/Moderate Dose/Low Dose (PML)|The PML group received a placebo on week one, moderate dose Methylphenidate (MPH) on week two, and a low dose of Methylphenidate (MPH) on week three.
416323|NCT00576472|P8|Participant Flow|Placebo/Low Dose/Moderate Dose (PLM)|The PLM group received a placebo on week one, low dose Methylphenidate (MPH) on week two, and a moderate dose of Methylphenidate (MPH) on week three.
416324|NCT00576472|P7|Participant Flow|Completed MPH In-Lab Phase/Not Randomized for Cross Over Phase|Patients who completed the MPH in Lab Phase but were not randomized for the MPH Cross-Over Phase
416325|NCT00576472|P6|Participant Flow|Group P/M|Group P/M (patients received oral placebo and then Methylphenidate (MPH))
416326|NCT00576472|P5|Participant Flow|Group M/P|Group M/P (patients received oral Methylphenidate (MPH) and then an oral placebo)
416327|NCT00576472|P4|Participant Flow|Screened/Didn't Qualify for Methylphenidate (MPH) In-Lab Phase|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase.
416328|NCT00576472|P3|Participant Flow|High Intensity|Intensity of prior CNS Therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy) classified as high.
416329|NCT00576472|P2|Participant Flow|Moderate Intensity|Intensity of prior CNS Therapy (< 24 Gy CRT with or without systemic and/or intrathecal chemotherapy)classified as moderate.
416330|NCT00576472|P1|Participant Flow|Mild Intensity|Intensity of prior CNS Therapy (systemic and/or intrathecal chemotherapy only)classified as mild.
416331|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416332|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416333|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416334|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416335|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416336|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416425|NCT00576420|P1|Participant Flow|FS VH S/D 500 S-apr - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 - seconds polymerization time
416426|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416427|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416741|NCT00575367|E2|Reported Event|Vigamox|
416337|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416338|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416339|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416340|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416341|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416342|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416343|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416344|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416345|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416346|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416347|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416348|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416428|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416429|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416349|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416350|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416351|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416352|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416353|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416354|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416355|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416356|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416357|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416358|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416359|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416360|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416437|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416625|NCT00576147|B1|Baseline|CT Scan|The standard head CT done to head trauma patients
416361|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416362|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416363|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416364|NCT00576472|O3|Outcome|MPH Versus Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416365|NCT00576472|O2|Outcome|Placebo|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416366|NCT00576472|O1|Outcome|MPH (Methylphenidate)|Of the 469 screened patients, 259 did not qualify for further medication phases, 75 qualified but refused to participate and 1 did not show for a scheduled appointment, leaving 134 patients to participate in the two-day Methylphenidate (MPH) In-Lab Phase. 67 patients were assigned to the Group M/P sequence and 67 were assigned to the Group P/M sequence. Patients were randomized into two sequence groups: 1) P/M: placebo followed by MPH; 2) M/P: MPH followed by placebo. We tested the difference in effects of MPH and placebo not the difference of two sequence groups.
416367|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416368|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416369|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416370|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416371|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416372|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416555|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416373|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416374|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416375|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416376|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416377|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416378|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416379|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416380|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416381|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416382|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416383|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416430|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416431|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416432|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416384|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416385|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416386|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416387|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416388|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416389|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416390|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416391|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416392|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416393|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416394|NCT00576472|O3|Outcome|Moderate Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 109 received the moderate dose. . T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416433|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416434|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416435|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416395|NCT00576472|O2|Outcome|Low Dose|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 119 received the low dose. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416396|NCT00576472|O1|Outcome|Placebo|Children qualifying for the 3-week, randomized Home MPH Crossover Trial will receive a combination of placebo, a low dose condition (0.3 mg/kg MPH; 10 mg maximum), and a moderate dose condition (0.6 mg/kg MPH; 20 mg maximum). There are six possible combinations of placebo (P), low dose MPH (LD), and moderate dose MPH (MD). Of the 122 children who began the Home Crossover Trial, 121 received the placebo. T Scores were estimated using a mixed model to account for carry-over effects. Mean and standard error were estimated by eliminating the effect of the carry-over from the directly measured mean.
416397|NCT00576472|O3|Outcome|Moderate Dose|Patients assigned to the Moderate Dose group were randomly assigned to receive one of two arms: Group MLP received moderate dose during week one, low dose during week 2, and placebo during week 3; Group MPL received moderate dose during week one, placebo during week 2, and low dose during week 3.
416398|NCT00576472|O2|Outcome|Low Dose|Patients assigned to the Low Dose group were randomly assigned to receive one of two arms: Group LMP received low dose during week one, moderate dose during week 2, and placebo during week 3; Group LPM received low dose during week one, placebo during week 2, and moderate dose during week 3.
416399|NCT00576472|O1|Outcome|Placebo|Patients assigned to the placebo group were randomly assigned to receive one of two arms: Group PLM received placebo during week one, low dose during week 2, and moderate dose during week 3; Group PML received placebo during week one, moderate dose during week 2, and low dose during week 3.
416400|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Math: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416401|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Spelling: Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416402|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the WIAT Reading: Composite Standard Score System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416403|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the Social Skills Rating System and 68 were screened at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416404|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: Cognitive Problem T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416405|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 68 were screened at the beginning of the trial using the CPRS: ADHD T Questionnaire and 68 were screen at completion. 68 patients were screened at both the beginning and end of the home maintenance phase.
416406|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: Cognitive Problem T Score Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
416407|NCT00576472|O1|Outcome|Overall|118 patients began the home maintenance phase of the trial. 68 completed the year long phase. 55 were screened at the beginning of the trial using the CTRS: ADHD T Questionnaire and 59 were screen at completion. 47 patients were screened at both the beginning and end of the home maintenance phase.
416408|NCT00576472|O4|Outcome|High Treatment Intensity|High intensity central nervous system therapy (>24 Gy CRT with or without systemic and/or intrathecal chemotherapy.
416409|NCT00576472|O3|Outcome|Moderate Treatment Intensity|Moderately intense central nervous system therapy (<= 24 Gy CRT with or without systemic and/or intrathecal chemotherapy).
416410|NCT00576472|O2|Outcome|Mild Treatment Intensity|Mildly intense central nervous system therapy (systemic and/or intrathecal chemotherapy only)
416411|NCT00576472|O1|Outcome|Siblings|The sibling control group received no radiation therapy.
416412|NCT00576472|O2|Outcome|Patients With Brain Tumors|Patients with brain tumors who had evaluable MRIs.
416413|NCT00576472|O1|Outcome|Patients With ALL|Patients with Acute Lymphoblastic Leukemia (ALL) who had evaluable MRIs.
416414|NCT00576472|O2|Outcome|Siblings|Sibling controls with evaluable MRIs.
416415|NCT00576472|O1|Outcome|Patients|Patients with evaluable MRIs.
416416|NCT00576472|E3|Reported Event|High|Intensity of prior Central Nervous System radiation therapy was considered high.
416417|NCT00576472|E2|Reported Event|Moderate|Intensity of prior Central Nervous System radiation therapy was considered moderate.
416418|NCT00576472|E1|Reported Event|Mild|Intensity of prior Central Nervous System radiation therapy was considered mild.
416419|NCT00576420|B4|Baseline|Total|Total of all reporting groups
416420|NCT00576420|B3|Baseline|Control Group|Manual compression with surgical gauze pads.
416421|NCT00576420|B2|Baseline|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
416422|NCT00576420|B1|Baseline|FS VH S/D 500 S-apr - 60 Seconds|FS VH S/D 500 s-apr, 60 - seconds polymerization time
416423|NCT00576420|P3|Participant Flow|Control Group|Manual compression with surgical gauze pads.
416424|NCT00576420|P2|Participant Flow|FS VH S/D 500 S-apr - 120 Seconds|FS VH S/D 500 s-apr, 120 - seconds polymerization time
416436|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416438|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416439|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416440|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416441|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416442|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416443|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416444|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416445|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416446|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416447|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416448|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416449|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416450|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416451|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416452|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416453|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416454|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416455|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416456|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416457|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416458|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416459|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416460|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416461|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416462|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416463|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416464|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416465|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416466|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416467|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416468|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416469|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416470|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416471|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416472|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416473|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416474|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416475|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416476|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416477|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416556|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416557|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
416478|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416479|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416480|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416481|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416482|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416483|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416484|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416485|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416486|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416487|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416488|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416489|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416490|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416491|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416492|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416493|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416494|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416495|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416496|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416497|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416498|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416499|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416500|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416501|NCT00576420|O8|Outcome|Control Group: Postoperative Day 14|Manual compression with surgical gauze pads
416502|NCT00576420|O7|Outcome|FS All: Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416503|NCT00576420|O6|Outcome|FS 120: Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416504|NCT00576420|O5|Outcome|FS 60: Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416505|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416506|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416507|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416508|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416509|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
416510|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416511|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416512|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416513|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
416514|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416515|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
416516|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
416517|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416626|NCT00576147|P1|Participant Flow|CT Scan|The standard head CT done to head trauma patients
416518|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416519|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416520|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416521|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
416522|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416523|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416524|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416525|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
416526|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416527|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
416528|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
416529|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
416530|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416531|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
416532|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 60-seconds polymerization
416533|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416534|NCT00576420|O3|Outcome|FS All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416535|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization
416536|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization
416537|NCT00576420|O12|Outcome|Control Group: Preoperative Baseline - Postoperative Day 14|Manual compression with surgical gauze pads
416538|NCT00576420|O11|Outcome|FS All: Preoperative Baseline - Postoperative Day 14|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416539|NCT00576420|O10|Outcome|FS 120: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 120-seconds polymerization
416540|NCT00576420|O9|Outcome|FS 60: Preoperative Baseline - Postoperative Day 14|FS VH S/D 500 s-apr, 60-seconds polymerization
416541|NCT00576420|O8|Outcome|Control Group: Preoperative Baseline - Postoperative Day 1|Manual compression with surgical gauze pads
416542|NCT00576420|O7|Outcome|FS All: Preoperative Baseline - Postoperative Day 1|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416543|NCT00576420|O6|Outcome|FS 120: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 120-seconds polymerization
416544|NCT00576420|O5|Outcome|FS 60: Preoperative Baseline - Postoperative Day 1|FS VH S/D 500 s-apr, 60-seconds polymerization
416545|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline - Intraoperative Day 0|Manual compression with surgical gauze pads
416546|NCT00576420|O3|Outcome|FS All: Preoperative Baseline - Intraoperative Day 0|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416547|NCT00576420|O2|Outcome|FS 120: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr, 120-seconds polymerization
416548|NCT00576420|O1|Outcome|FS 60: Preoperative Baseline - Intraoperative Day 0|FS VH S/D 500 s-apr (FS), 60-seconds polymerization
416549|NCT00576420|O4|Outcome|Control Group: Preoperative Baseline|Manual compression with surgical gauze pads
416550|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All: Preoperative Baseline|"All study participants who received Fibrin Sealant (60 + 120 Seconds polymerization time) (FS All):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416551|NCT00576420|O2|Outcome|FS VH S/D 500 S -Apr - 120: Preoperative Baseline|FS VH S/D 500 s-apr, 120-seconds polymerization (FS 120)
416552|NCT00576420|O1|Outcome|FS VH S/D 500 S -Apr - 60: Preoperative Baseline|FS VH S/D 500 s-apr, 60-seconds polymerization (FS 60)
416553|NCT00576420|O4|Outcome|Control Group|Manual compression with surgical gauze pads
416554|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416558|NCT00576420|O3|Outcome|FS VH S/D 500 S-apr - All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time~FS VH S/D 500 s-apr, 120-seconds polymerization time"
416559|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416560|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-Seconds polymerization time
416561|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416562|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416563|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416564|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416565|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization.
416566|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
416567|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416568|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416569|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416570|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416571|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416572|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416573|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416574|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416575|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416576|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416577|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416578|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416579|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416580|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416581|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr - 60-Seconds|FS VH S/D 500 s-apr, 60-seconds polymerization time
416582|NCT00576420|O3|Outcome|Control Group|Manual compression with surgical gauze pads.
416583|NCT00576420|O2|Outcome|FS VH S/D 500 S-apr - 120-Seconds|FS VH S/D 500 s-apr, 120-seconds polymerization time
416584|NCT00576420|O1|Outcome|FS VH S/D 500 S-apr- 60-Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60-seconds polymerization time
416585|NCT00576420|E4|Reported Event|Control Group|Treatment of the study-suture line will be manual compression with surgical gauze pads.
416586|NCT00576420|E3|Reported Event|Fibrin Sealant All - (60 + 120 Seconds)|"All study participants who received Fibrin Sealant (60 + 120 Seconds):~Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time~FS VH S/D 500 s-apr, 120 seconds polymerization time"
416587|NCT00576420|E2|Reported Event|Fibrin Sealant - 120 Seconds|FS VH S/D 500 s-apr, 120 seconds polymerization time
416588|NCT00576420|E1|Reported Event|Fibrin Sealant - 60 Seconds|Fibrin Sealant, Vapor Heated, Solvent/Detergent-treated with 500 IU/ml thrombin and synthetic aprotinin (FS VH S/D 500 s-apr), 60 seconds polymerization time
416589|NCT00576381|B1|Baseline|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
416590|NCT00576381|P1|Participant Flow|Neonatal Dose Escalation Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25 mcg/kg loading dose, 0.2 mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
416591|NCT00576381|O1|Outcome|Neonates|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Cohort 1--0.25mcg/kg loading dose, 0.2mcg/kg/hr infusion Cohort 1A--0.35 mcg/kg loading dose, 0.3 mcg/kg/hr infusion Cohort 2--0.5 mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
416592|NCT00576381|E1|Reported Event|Dosing Cohorts|"Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infuusion for up to 24 hours post cardiac surgery.~Dexmedetomidine : Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion"
416593|NCT00576316|B1|Baseline|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
416594|NCT00576316|P1|Participant Flow|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
416595|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
416596|NCT00576316|O1|Outcome|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
416597|NCT00576316|E1|Reported Event|Symbicort 160/4.5 Turbuhaler|Treatment with Symbicort 160/4.5 Turbuhaler 1 or 2 inhalations twice daily and when required as reliever
416624|NCT00576199|E1|Reported Event|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416598|NCT00576303|B1|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416599|NCT00576303|P1|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A]) intravenously, at a dose of 120, 200 or 360 microgram (µg) every four weeks. The dose of C.E.R.A was based on the erythropoiesis stimulating agents (ESA) like epoetin alfa or beta dose of<8000, 8000-16000, or >16000 international units (IU)/week, administered during the stability verification period (SVP) of 4 weeks. The SVP period was followed by dose titration period (DTP) of 16 weeks, efficacy evaluation period (EEP) of 8 weeks and long term safety period (LTSP) of 28 weeks
416600|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416601|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416602|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416603|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416604|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416605|NCT00576303|O1|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416606|NCT00576303|E1|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants started RO0503821 (C.E.R.A) intravenously, at a dose of 120, 200 or 360 µg every four weeks. The dose of C.E.R.A was based on the ESA like epoetin alfa or beta dose of <8000, 8000-16000, or >16000 IU/week, administered during the SVP of 4 weeks. The SVP was followed by DTP of 16 weeks, EEP of 8 weeks and LTSP of 28 weeks
416607|NCT00576251|B3|Baseline|Total|Total of all reporting groups
416608|NCT00576251|B2|Baseline|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
416609|NCT00576251|B1|Baseline|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
416610|NCT00576251|P2|Participant Flow|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
416611|NCT00576251|P1|Participant Flow|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
416612|NCT00576251|O2|Outcome|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
416613|NCT00576251|O1|Outcome|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
416614|NCT00576251|E2|Reported Event|TOBRADEX Ophthalmic Suspension|TOBRADEX Ophthalmic Suspension
416615|NCT00576251|E1|Reported Event|Tobramycin 0.3%/Dexamethasone 0.05%|Tobramycin 0.3%/Dexamethasone 0.05%
416616|NCT00576199|B1|Baseline|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416617|NCT00576199|P1|Participant Flow|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416618|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416619|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416620|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416621|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416622|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416623|NCT00576199|O1|Outcome|Bevacizumab 5 mg/kg|Participants received bevacizumab 5 mg/kg intravenously every 2 weeks and within 24-48 hours prior to each transarterial chemoembolization (TACE) until disease progression or unmanageable toxicity. TACE was conducted for 4 sessions at 8-10 week intervals.
416667|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416627|NCT00576147|O1|Outcome|CT Scan|The standard head CT done to head trauma patients
416628|NCT00576147|E1|Reported Event|CT Scan|The standard head CT done to head trauma patients
416629|NCT00576056|B1|Baseline|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
416630|NCT00576056|P1|Participant Flow|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
416631|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
416632|NCT00576056|O1|Outcome|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
416633|NCT00576056|E1|Reported Event|Tace + Sorafenib|"Patients with unresectable HCC will be treated with TACE in combination with oral sorafenib administration. TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment.~TACE + Sorafenib: TACE will be accomplished with gelatin microspheres (Embospheres) following delivery of 125 mg/m2 of cisplatin. Oral sorafenib (400 mg BID) will start the next day after the first TACE treatment until unacceptable toxicity occurs, or until study termination."
416634|NCT00575965|B1|Baseline|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
416635|NCT00575965|P1|Participant Flow|Simvastatin|Single arm, phase II study. All 18 patients received study drug.
416636|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
416637|NCT00575965|O1|Outcome|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
416638|NCT00575965|E1|Reported Event|Simvastatin|Simvastatin at 20 mg daily for the first week, then dose escalated weekly by 20 mg a day to a maximum of 80 mg daily by week 4. Patients were maintained on therapy until progression or up to 2 years.
416639|NCT00575887|B1|Baseline|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
416640|NCT00575887|P1|Participant Flow|Dose-Dense Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
416641|NCT00575887|O1|Outcome|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
416642|NCT00575887|E1|Reported Event|Temozolomide|"Temozolomide : 100 mg/m2/day, (PO) orally, on days between 1 and 21 of each 28 day cycles.~Number of cycles: Until progression or unacceptable toxicity"
416643|NCT00575666|B3|Baseline|Total|Total of all reporting groups
416644|NCT00575666|B2|Baseline|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
416645|NCT00575666|B1|Baseline|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
416646|NCT00575666|P2|Participant Flow|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
416647|NCT00575666|P1|Participant Flow|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
416648|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416649|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416650|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416651|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416652|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416653|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416654|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416655|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416656|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416657|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416658|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416659|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416660|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416661|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416662|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416663|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416664|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416665|NCT00575666|O1|Outcome|Humulin|160 IU per day for 8 weeks
416666|NCT00575666|O2|Outcome|Placebo|160 IU per day for 8 weeks
416682|NCT00575666|E2|Reported Event|Intervention: Placebo|Placebo group, daily dosage 160 IU placebo for 8 weeks with 4 week follow-up
416683|NCT00575666|E1|Reported Event|Intervention: Insulin|Intranasal insulin treatment, daily dosage 160 IU insulin for 8 weeks with a 4 week follow-up
416684|NCT00575588|B3|Baseline|Total|Total of all reporting groups
416685|NCT00575588|B2|Baseline|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416686|NCT00575588|B1|Baseline|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416687|NCT00575588|P2|Participant Flow|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416688|NCT00575588|P1|Participant Flow|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416689|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416690|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416691|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416692|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416693|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416694|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416695|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416696|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416697|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416698|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416699|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416700|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416701|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416702|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416703|NCT00575588|O2|Outcome|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416704|NCT00575588|O1|Outcome|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416705|NCT00575588|E2|Reported Event|Glipizide + Metformin|Glipizide 5-20 mg capsules (titrated to optimal effect or highest tolerable dose during 18 weeks) added on to open-label metformin
416706|NCT00575588|E1|Reported Event|Saxagliptin + Metformin|Saxagliptin 5 mg tablets added on to open-label metformin
416707|NCT00575510|B4|Baseline|Total|Total of all reporting groups
416708|NCT00575510|B3|Baseline|Standard Care Only|Clinical standard of care at time of study
416709|NCT00575510|B2|Baseline|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
416710|NCT00575510|B1|Baseline|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
416711|NCT00575510|P3|Participant Flow|Standard Care Only|Clinical standard of care at time of study
416712|NCT00575510|P2|Participant Flow|Active Control|nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
416713|NCT00575510|P1|Participant Flow|Intervention|Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling
416714|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
416715|NCT00575510|O2|Outcome|Active Control|"non-targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
416716|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
416717|NCT00575510|O3|Outcome|Standard Care Only|Clinical standard of care at time of study
416718|NCT00575510|O2|Outcome|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
416719|NCT00575510|O1|Outcome|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
416720|NCT00575510|E3|Reported Event|Standard Care Only|Clinical standard of care at time of study
416721|NCT00575510|E2|Reported Event|Active Control|"nontargeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Active control: Partial intervention (full intervention minus cultural-specific component)"
416722|NCT00575510|E1|Reported Event|Intervention|"Culturally targeted behavioral and normative beliefs + knowledge/skills + salience + environmental constraints/barriers counseling~Intervention: Multiple component intervention based in the unified theory of behavior"
416723|NCT00575380|B3|Baseline|Total|Total of all reporting groups
416724|NCT00575380|B2|Baseline|Vigamox|
416725|NCT00575380|B1|Baseline|Azasite|
416726|NCT00575380|P2|Participant Flow|Vigamox|
416727|NCT00575380|P1|Participant Flow|Azasite|
416742|NCT00575367|E1|Reported Event|AzaSite|
416743|NCT00575185|B3|Baseline|Total|Total of all reporting groups
416744|NCT00575185|B2|Baseline|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
416745|NCT00575185|B1|Baseline|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
416746|NCT00575185|P2|Participant Flow|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
416747|NCT00575185|P1|Participant Flow|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
416748|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo: Placebo tablets orally twice daily for 21 days."
416749|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir: 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
416750|NCT00575185|O2|Outcome|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
416751|NCT00575185|O1|Outcome|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
416752|NCT00575185|E2|Reported Event|Placebo|"placebo 2 tablets twice daily for 21 days~placebo : Placebo tablets orally twice daily for 21 days."
416753|NCT00575185|E1|Reported Event|Valomaciclovir|"Valomaciclovir 2 grams orally twice daily for 21 days~Valomaciclovir : 4 grams orally of valomaciclovir (2 grams BID) for 21 days."
416754|NCT00575146|B1|Baseline|Ketogenic Diet|ketogenic diet
416755|NCT00575146|P1|Participant Flow|Ketogenic Diet|unrestricted ketogenic diet (< 50-60 g carbohydrates per day) and dietary supplementary products provided by Tavarlin
416756|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
416757|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
416758|NCT00575146|O1|Outcome|Ketogenic Diet|unrestricted ketogenic diet
416759|NCT00575146|E1|Reported Event|Ketogenic Diet|ketogenic diet
416760|NCT00575094|B1|Baseline|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
416761|NCT00575094|P1|Participant Flow|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
416762|NCT00575094|O1|Outcome|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
416763|NCT00575094|E1|Reported Event|Tigecycline|Intravenous (IV) administration for 7 to 14 consecutive days at the discretion of the investigator.
416764|NCT00575042|B1|Baseline|Patients Treated With Fenofibrate|
416765|NCT00575042|P1|Participant Flow|Patients Treated With Fenofibrate|
416766|NCT00575042|O2|Outcome|Post Treatment|
416767|NCT00575042|O1|Outcome|Pre Treatment|
416768|NCT00575042|E1|Reported Event|Patients Treated With Fenofibrate|
416769|NCT00575029|B1|Baseline|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
416770|NCT00575029|P1|Participant Flow|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
416771|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
416772|NCT00575029|O1|Outcome|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
416773|NCT00575029|E1|Reported Event|Megestrol Acetate|Study subjects will be given 600mg of MA (megestrol acetate) for oral ingestion per day for duration of 8 weeks.
416774|NCT00575016|B5|Baseline|Total|Total of all reporting groups
416775|NCT00575016|B4|Baseline|Placebo|Normal saline (placebo)
416776|NCT00575016|B3|Baseline|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416777|NCT00575016|B2|Baseline|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416778|NCT00575016|B1|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416779|NCT00575016|P4|Participant Flow|Placebo|Normal saline (placebo)
416780|NCT00575016|P3|Participant Flow|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416781|NCT00575016|P2|Participant Flow|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416782|NCT00575016|P1|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416783|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
416784|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416785|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416786|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416787|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
416788|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416789|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416790|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416791|NCT00575016|O4|Outcome|Placebo|Normal saline (placebo)
416792|NCT00575016|O3|Outcome|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416793|NCT00575016|O2|Outcome|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416794|NCT00575016|O1|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416795|NCT00575016|E4|Reported Event|Placebo|Normal saline (placebo)
416796|NCT00575016|E3|Reported Event|Botulinum Toxin Type A (50U)|botulinum toxin Type A (50U)
416797|NCT00575016|E2|Reported Event|Botulinum Toxin Type A (100U)|botulinum toxin Type A (100U)
416798|NCT00575016|E1|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
416799|NCT00574990|B4|Baseline|Total|Total of all reporting groups
416800|NCT00574990|B3|Baseline|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416801|NCT00574990|B2|Baseline|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416802|NCT00574990|B1|Baseline|VA Physicians|VA physicians who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416803|NCT00574990|P3|Participant Flow|VA Pharmacists|VA Pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416804|NCT00574990|P2|Participant Flow|VA Nurses|VA Nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416805|NCT00574990|P1|Participant Flow|VA Physicians|VA Physicians who have spent at least one year in the VA and be familiar with the VA's electronic health record, CPRS.
416806|NCT00574990|O3|Outcome|VA Pharmacists|VA pharmacists who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416807|NCT00574990|O2|Outcome|VA Nurses|VA nurses who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416808|NCT00574990|O1|Outcome|VA Physicians|VA providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416809|NCT00574990|O3|Outcome|Pharmacists|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416810|NCT00574990|O2|Outcome|Nurses|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416811|NCT00574990|O1|Outcome|Physicians|Participants were providers who had worked at least one year in the VA and were familiar with the VA's electronic health record, CPRS.
416812|NCT00574990|E3|Reported Event|VA Pharmacists|VA Pharmacists who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
416813|NCT00574990|E2|Reported Event|VA Nurses|VA Nurses who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
416814|NCT00574990|E1|Reported Event|VA Physicians|VA Physicians who had worked at the VA for at least one year and were familiar with the VA's electronic health record, CPRS.
416815|NCT00574912|B1|Baseline|1--All Interventions|"Arm: Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
416816|NCT00574912|P1|Participant Flow|1 All Interventions|"Other: 1--All interventions~All participant will be given all 5 interventions in the same order~Placebo, then 0.5 units of Glargine/kg body weight, then 1.0 units of Glargine/kg body weight, then 1.5 units of Glargine/kg body weight, then 2.0 units of Glargine/kg body weight,"
416817|NCT00574912|O5|Outcome|5/2.0 Units of Glargine/kg|maximum glucose infusion rate
416818|NCT00574912|O4|Outcome|4/1.5 Units of Glargine/kg|maximum glucose infusion rate
416819|NCT00574912|O3|Outcome|3/1.0 Units of Glargine/kg|maximum glucose infusion rate
416820|NCT00574912|O2|Outcome|2/0.5 Units of Glargine/kg|maximum glucose infusion rate
416821|NCT00574912|O1|Outcome|1/0.0 Placebo|Maximum glucose infusion rate
416822|NCT00574912|E5|Reported Event|5/2.0|"2.0 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
416823|NCT00574912|E4|Reported Event|4/1.5|"1.5 units of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
416824|NCT00574912|E3|Reported Event|3/1.0|"1 unit of glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
416825|NCT00574912|E2|Reported Event|2/0.5|"0.5 units of Glargine/kg body weight~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
416826|NCT00574912|E1|Reported Event|1/0.0|"Placebo~Insulin Glargine: administering single, differing dose of insulin glargine over a 24 hour period every 8 weeks times five"
416827|NCT00574873|B3|Baseline|Total|Total of all reporting groups
416828|NCT00574873|B2|Baseline|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416829|NCT00574873|B1|Baseline|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416830|NCT00574873|P2|Participant Flow|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416831|NCT00574873|P1|Participant Flow|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416832|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416833|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416834|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416835|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416836|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416837|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416838|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416839|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416840|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416841|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416842|NCT00574873|O2|Outcome|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416843|NCT00574873|O1|Outcome|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416844|NCT00574873|E2|Reported Event|Imatinib|Imatinib 400 mg tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to imatinib 600 mg tablet orally once daily or a reduction to imatinib 300 mg tablet orally once daily.
416845|NCT00574873|E1|Reported Event|Bosutinib|Bosutinib 500 milligram (mg) tablet orally once daily up to 5 years or until treatment failure, unacceptable toxicity, death, withdrawal of consent. Dose adjustments, if needed, included an escalation to bosutinib 600 mg tablet orally once daily or a reduction to bosutinib 300 mg tablet orally once daily.
416846|NCT00574847|B3|Baseline|Total|Total of all reporting groups
416847|NCT00574847|B2|Baseline|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416848|NCT00574847|B1|Baseline|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416849|NCT00574847|P2|Participant Flow|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416850|NCT00574847|P1|Participant Flow|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416851|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416852|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416853|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416854|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416855|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416856|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416857|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416858|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416859|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416860|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416861|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416862|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416863|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416864|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416865|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416866|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416867|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416868|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416869|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416870|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416871|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416872|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416873|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416874|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416875|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416876|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416877|NCT00574847|O2|Outcome|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416878|NCT00574847|O1|Outcome|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416879|NCT00574847|E2|Reported Event|Placebo|Placebo: Placebo dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416880|NCT00574847|E1|Reported Event|Escitalopram|Escitalopram: Dosage will range from 5 mg to 20 mg once a day for the duration of the study (6 weeks). Tablets are in 5 mg or 10 mg form, depending upon the dosage the patient is prescribed.
416881|NCT00574834|B4|Baseline|Total|Total of all reporting groups
416882|NCT00574834|B3|Baseline|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
416883|NCT00574834|B2|Baseline|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
416884|NCT00574834|B1|Baseline|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
416885|NCT00574834|P3|Participant Flow|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
416886|NCT00574834|P2|Participant Flow|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
416887|NCT00574834|P1|Participant Flow|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
416888|NCT00574834|O3|Outcome|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
416889|NCT00574834|O2|Outcome|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
416890|NCT00574834|O1|Outcome|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
416891|NCT00574834|E3|Reported Event|Ramipril+HCTZ|"Patients randomized to 6 months treatment of Ramipril+HCTZ.~Ramipril+HCTZ: Ramipril 20 mg and HCTZ 25 mg, both once daily for 6 months"
416892|NCT00574834|E2|Reported Event|HCTZ|"Patients randomized to 6 months treatment of HCTZ.~HCTZ-hydrochlorothiazide: HCTZ 25 mg once daily for 6 months"
416893|NCT00574834|E1|Reported Event|Ramipril|"Patients randomized to 6 months treatment of Ramipril.~Ramipril: Ramipril 20 mg once daily for 6 months"
416894|NCT00574795|B1|Baseline|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
416895|NCT00574795|P1|Participant Flow|13vPnC|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series) and 12-15 months of age (toddler dose).
416896|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
416897|NCT00574795|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12-15 months of age (toddler dose)
416898|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
416899|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
416900|NCT00574795|O3|Outcome|13vPnC Dose 3|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
416901|NCT00574795|O2|Outcome|13vPnC Dose 2|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
416902|NCT00574795|O1|Outcome|13vPnC Dose 1|Subjects received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
416903|NCT00574795|O4|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months of age (toddler dose).
416904|NCT00574795|O3|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 6 months of age (infant series Dose 3).
416905|NCT00574795|O2|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 4 months of age (infant series Dose 2).
416906|NCT00574795|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2 months of age (infant series Dose 1).
416907|NCT00574795|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
416908|NCT00574795|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12-15 months (toddler dose).
416909|NCT00574795|E2|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
416910|NCT00574795|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at approximately 2, 4, 6 months (infant series).
416911|NCT00574704|B5|Baseline|Total|Total of all reporting groups
416912|NCT00574704|B4|Baseline|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416913|NCT00574704|B3|Baseline|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416914|NCT00574704|B2|Baseline|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
416915|NCT00574704|B1|Baseline|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
416916|NCT00574704|P4|Participant Flow|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416917|NCT00574704|P3|Participant Flow|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416918|NCT00574704|P2|Participant Flow|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
416919|NCT00574704|P1|Participant Flow|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
416920|NCT00574704|O4|Outcome|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416921|NCT00574704|O3|Outcome|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416922|NCT00574704|O2|Outcome|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
416923|NCT00574704|O1|Outcome|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
416924|NCT00574704|E4|Reported Event|Placebo|CYT003-QbG10-placebo in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416925|NCT00574704|E3|Reported Event|QbG10|CYT003-AllQbG10 in combination with house dust mite allergen extract placebo : subcutaneous injections at 6 visits
416926|NCT00574704|E2|Reported Event|Allergen|House dust mite allergen extract in combination with CYT003-QbG10-placebo : subcutaneous injections at 6 visits
416927|NCT00574704|E1|Reported Event|AllQbG10|CYT005-AllQbG10 (combination of house dust mite allergen extract with CYT003-QbG10) : subcutaneous injections at 6 visits
416928|NCT00574548|B3|Baseline|Total|Total of all reporting groups
416929|NCT00574548|B2|Baseline|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416930|NCT00574548|B1|Baseline|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416931|NCT00574548|P2|Participant Flow|23vPS - Group 2|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416932|NCT00574548|P1|Participant Flow|13vPnC - Group 1.1 or 1.2|Group 1.1: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416933|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416934|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416935|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416936|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416937|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
416938|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416939|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416940|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416941|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416942|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
416943|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416944|NCT00574548|O3|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416945|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416946|NCT00574548|O1|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416947|NCT00574548|O2|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416948|NCT00574548|O1|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
416949|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416950|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416951|NCT00574548|O2|Outcome|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416952|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416953|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
416954|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416955|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416956|NCT00574548|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416957|NCT00574548|O2|Outcome|13vPnC / 23vPS Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416958|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416959|NCT00574548|O2|Outcome|13vPnC / 13vPnC Vaccination 2 (Year 1)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416960|NCT00574548|O1|Outcome|13vPnC Vaccination 1 (Year 0)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0.
416961|NCT00574548|O2|Outcome|23vPS / 13vPnC|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416962|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416963|NCT00574548|O2|Outcome|23vPS|23vPS administered as a single dose 0.5 mL IM at Year 0.
416964|NCT00574548|O1|Outcome|13vPnC / 23vPS|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose 0.5 milliliter (mL) intramuscularly (IM) at Year 0. 23-valent polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL IM at Year 1.
416965|NCT00574548|E10|Reported Event|23vPS / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416966|NCT00574548|E9|Reported Event|13vPnC / 23vPS: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
416967|NCT00574548|E8|Reported Event|13vPnC / 13vPnC: 6 Month Follow-up After Vax 2 (Year 1)|13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416968|NCT00574548|E7|Reported Event|23vPS / 13vPnC (Year 1)|"23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=32; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=68."
416994|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416969|NCT00574548|E6|Reported Event|13vPnC / 23vPS (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=50; systematic (solicited) Local Reactions N=198; systematic (solicited) Systemic Events N=120."
416970|NCT00574548|E5|Reported Event|13vPnC / 13vPnC (Year 1)|"13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=22; systematic (solicited) Local Reactions N=97; systematic (solicited) Systemic Events N=54."
416971|NCT00574548|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1 (Year 0)|Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.
416972|NCT00574548|E3|Reported Event|13vPnC: 6 Month Follow-up After Vax 1 (Year 0)|Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.
416973|NCT00574548|E2|Reported Event|23vPS (Year 0)|"Group 2: 23vPS administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=49; systematic (solicited) Local Reactions N=102; systematic (solicited) Systemic Events N=86."
416974|NCT00574548|E1|Reported Event|13vPnC (Year 0)|"Group 1.1: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 13vPnC administered as a single dose 0.5 mL IM at Year 1; or Group 1.2: 13vPnC administered as a single dose 0.5 mL IM at Year 0. 23vPS administered as a single dose 0.5 mL IM at Year 1.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=90; systematic (solicited) Local Reactions N=256; systematic (solicited) Systemic Events N=163."
416975|NCT00574405|B3|Baseline|Total|Total of all reporting groups
416976|NCT00574405|B2|Baseline|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
416977|NCT00574405|B1|Baseline|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
416978|NCT00574405|P2|Participant Flow|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
416979|NCT00574405|P1|Participant Flow|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
416980|NCT00574405|O2|Outcome|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
416981|NCT00574405|O1|Outcome|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
416982|NCT00574405|E2|Reported Event|Insulin Pump Therapy, Started at Diagnosis.|Continuous subcutaneous infusion therapy (insulin pump therapy), using Animas Corporation insulin pump, model IR 1200, started within 1 month of diagnosis with Type 1 diabetes, in patients 8-18 years of age, and monitored for 12 months after diagnosis.
416983|NCT00574405|E1|Reported Event|Multiple Daily Injection Therapy|Multiple daily injection therapy, using split-mix NPH insulin + regular insulin or Lantus + Novolog® (or Humalog®) started at the time of diagnosis of Type 1 diabetes in patient 8-18 years of age and monitored for 12 months after diagnosis.
416984|NCT00574340|B1|Baseline|Glucose Clamp|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
416985|NCT00574340|P1|Participant Flow|Glucose Clamp|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
416986|NCT00574340|O1|Outcome|Glucose Clamp|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
416987|NCT00574340|E1|Reported Event|Glucose Clamp|"Day 1 euglycemia, day 2 hypoglycemia~Hyperinsulinemic Hypoglycemic Clamp: hyperinsulinemic glucose clamp separated by 8 weeks"
416988|NCT00574275|B3|Baseline|Total|Total of all reporting groups
416989|NCT00574275|B2|Baseline|Aflibercept/Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416990|NCT00574275|B1|Baseline|Placebo/Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416991|NCT00574275|P2|Participant Flow|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416992|NCT00574275|P1|Participant Flow|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416993|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
419762|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
416995|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416996|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416997|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416998|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
416999|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417000|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417001|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417002|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417003|NCT00574275|O2|Outcome|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417004|NCT00574275|O1|Outcome|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417005|NCT00574275|E2|Reported Event|Aflibercept and Gemcitabine|"Aflibercept: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417006|NCT00574275|E1|Reported Event|Placebo and Gemcitabine|"Placebo: 4 mg/kg was administered IV over 1 hour once every 2 weeks, on Days 1 and 15 of each 28-day cycle.~Gemcitabine: 1000 mg/m^2 administered IV over 30 minutes on Days 1, 8, 15, and 22 of Cycle 1 (28 days), and then Days 1, 8, and 15 of subsequent 28-day cycles."
417007|NCT00574249|B3|Baseline|Total|Total of all reporting groups
417008|NCT00574249|B2|Baseline|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417009|NCT00574249|B1|Baseline|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417010|NCT00574249|P2|Participant Flow|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment: subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 though Week 15 - topical ointment (calcipotriol 50 mcg/g and betamethasone 500 mg/g) to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 through Week 16 (maximum 100 g per week)
417011|NCT00574249|P1|Participant Flow|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15 - placebo vehicle ointment to be applied once daily to affected psoriasis skin on trunk and extremities for first 4 weeks and as needed from Week 5 though Week 16 (maximum dose of 100 g per week)
417012|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417013|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417014|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417015|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417016|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417017|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417018|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417019|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417020|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417021|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417022|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417023|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417024|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417025|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417026|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417027|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417028|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417029|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417030|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417031|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417032|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417033|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417034|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417035|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417036|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417037|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417038|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417039|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417040|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417041|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417042|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417043|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417044|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417045|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417046|NCT00574249|O2|Outcome|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417047|NCT00574249|O1|Outcome|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417048|NCT00574249|E2|Reported Event|Adalimumab + Calcipotriol/Betamethasone|adalimumab + calcipotriol/betamethasone ointment
417049|NCT00574249|E1|Reported Event|Adalimumab + Placebo|adalimumab + placebo (vehicle ointment): subcutaneous injection using prefilled pen/syringe, solution containing 40 mg adalimumab in 0.8 milliliters; 2 injections given at Baseline (Day 1) then one injection every other week from Week 1 through Week 15
417050|NCT00574171|B1|Baseline|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
417051|NCT00574171|P1|Participant Flow|Lapatinib and Capecitabine|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
417052|NCT00574171|O1|Outcome|Lapatinib/Capecitabine|lapatinib: 1250mg by mouth daily one hour before or after breakfast on a continuous basis. Capecitabine: 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.
417053|NCT00574171|E1|Reported Event|Arm 1|"Capecitabine : 2000mg/m2 of body surface area (BSA), by mouth, divided into twice daily dosing. Capecitabine will be given for days 1 through 14 of a 21 day cycle.~lapatinib : 1250mg by mouth daily one hour before or after breakfast on a continuous basis."
417054|NCT00574145|B3|Baseline|Total|Total of all reporting groups
417055|NCT00574145|B2|Baseline|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
417056|NCT00574145|B1|Baseline|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
417057|NCT00574145|P2|Participant Flow|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
417058|NCT00574145|P1|Participant Flow|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
417059|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
417060|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
417061|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
417062|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
417063|NCT00574145|O2|Outcome|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing-touch therapist once a week for the duration of their radiotherapy
417064|NCT00574145|O1|Outcome|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing-touch therapist once a week for the duration of their radiotherapy
417065|NCT00574145|E2|Reported Event|Control ARM (B)|Patients receive radiotherapy and sham healing touch therapy from a sham healing touch therapist once a week for the duration of their radiotherapy
417066|NCT00574145|E1|Reported Event|Radiotherapy/Supportive Care (A)|Patients receive radiotherapy and healing touch therapy from a healing touch therapist once a week for the duration of their radiotherapy
417067|NCT00574080|B3|Baseline|Total|Total of all reporting groups
417068|NCT00574080|B2|Baseline|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417069|NCT00574080|B1|Baseline|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417070|NCT00574080|P2|Participant Flow|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417071|NCT00574080|P1|Participant Flow|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417072|NCT00574080|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|
417073|NCT00574080|E2|Reported Event|DPACE/Melphalan|Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417074|NCT00574080|E1|Reported Event|VTD + DPACE/Melphalan|Velcade, thalidomide, and dexamethasone + Dexamethasone, CisPlatin, Adriamycin, Cyclophosphamide, and Etoposide & Melphalan
417075|NCT00574067|B5|Baseline|Total|Total of all reporting groups
417076|NCT00574067|B4|Baseline|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417077|NCT00574067|B3|Baseline|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417078|NCT00574067|B2|Baseline|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417079|NCT00574067|B1|Baseline|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417080|NCT00574067|P4|Participant Flow|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417081|NCT00574067|P3|Participant Flow|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417082|NCT00574067|P2|Participant Flow|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417083|NCT00574067|P1|Participant Flow|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417218|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417219|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
417084|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417085|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417086|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417087|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417088|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417089|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417090|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417091|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417092|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417093|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417094|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417095|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417096|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417097|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417098|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417099|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417100|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417101|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417102|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417103|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417220|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417104|NCT00574067|O4|Outcome|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417105|NCT00574067|O3|Outcome|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417106|NCT00574067|O2|Outcome|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417107|NCT00574067|O1|Outcome|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417108|NCT00574067|O4|Outcome|Counseling+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417109|NCT00574067|O3|Outcome|Counseling+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417110|NCT00574067|O2|Outcome|Bup+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417111|NCT00574067|O1|Outcome|Bup+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417112|NCT00574067|E4|Reported Event|C+CHC|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at a community health center to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417113|NCT00574067|E3|Reported Event|C+OTP|Buprenorphine: Counseling only for 4 months in pre-release prison, with referral upon release for buprenorphine treatment and counseling at an opioid agonist treatment program to last for 1 year. Following an induction period, buprenorphine dosing will be thrice weekly, with 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417114|NCT00574067|E2|Reported Event|B+CHC|Buprenorphine: Buprenorphine thrice weekly and counseling provided in pre-release prison for 4 months, with referral for continued treatment for 1 year in the community at a community health center. Following an induction period, buprenorphine dosing will be 32 mg on Mondays and Wednesdays and 48 mg on Fridays.
417115|NCT00574067|E1|Reported Event|B+OTP|Buprenorphine: Buprenorphine thrice weekly and counseling for four months while in pre-release prison, with referral for continued treatment at an opioid agonist treatment program upon release. Such treatment lasts for 1 year in the community. Buprenorphine dosage, following an induction period,is 32 mg Mondays and Wednesdays and 48 mg Fridays
417116|NCT00573937|B3|Baseline|Total|Total of all reporting groups
417117|NCT00573937|B2|Baseline|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
417118|NCT00573937|B1|Baseline|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
417119|NCT00573937|P2|Participant Flow|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
417120|NCT00573937|P1|Participant Flow|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
417121|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
417122|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
417123|NCT00573937|O2|Outcome|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
417124|NCT00573937|O1|Outcome|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
417125|NCT00573937|E2|Reported Event|Morphine|Oral slow-release morphine (15 mg) every 8 hours, and immediate-release morphine (10 mg) every 4 hours as needed for breakthrough pain.
417126|NCT00573937|E1|Reported Event|Methadone|Oral methadone 2.5 mg every 8 hours, and oral methadone 2.5 mg every 4 hours as needed for breakthrough pain.
417127|NCT00573859|B1|Baseline|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417128|NCT00573859|P1|Participant Flow|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417129|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417130|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417131|NCT00573859|O1|Outcome|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417132|NCT00573859|E1|Reported Event|ADHD Medication Versus Placebo|Smokers with ADHD participated in two consecutive days under ADHD medication versus 2 consecutive days on placebo. For the ADHD medication condition, participants received their usual dosage of their usual medication in the morning of each monitoring day. For the placebo condition, a placebo pill was provided in the morning of each day. The smoking period assessed the effects of the first cigarette of the day on secondary outcome measures. The abstinence period assessed the effects of overnight abstinence on the secondary outcome measures.
417133|NCT00573768|B4|Baseline|Total|Total of all reporting groups
417134|NCT00573768|B3|Baseline|Vehicle Gel|BID application
417135|NCT00573768|B2|Baseline|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
417136|NCT00573768|B1|Baseline|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
417137|NCT00573768|P3|Participant Flow|Vehicle Gel|BID application
417138|NCT00573768|P2|Participant Flow|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
417139|NCT00573768|P1|Participant Flow|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
417140|NCT00573768|O3|Outcome|Vehicle Gel|BID application
417141|NCT00573768|O2|Outcome|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
417142|NCT00573768|O1|Outcome|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
417143|NCT00573768|E3|Reported Event|Vehicle Gel|BID application
417144|NCT00573768|E2|Reported Event|DDEA 2.32% Gel OD|Once daily (OD) application of active gel and OD application of vehicle gel
417145|NCT00573768|E1|Reported Event|Diclofenac Diethylamine (DDEA) 2.32% Gel BID|Twice daily (BID) application
417146|NCT00573755|B3|Baseline|Total|Total of all reporting groups
417147|NCT00573755|B2|Baseline|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417148|NCT00573755|B1|Baseline|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417149|NCT00573755|P2|Participant Flow|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417150|NCT00573755|P1|Participant Flow|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417151|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417152|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417153|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417154|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417155|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417156|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417157|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417158|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
419763|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
417159|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417160|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417161|NCT00573755|O2|Outcome|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417162|NCT00573755|O1|Outcome|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417163|NCT00573755|E2|Reported Event|Placebo Plus Aromatase Inhibitor|Patients receive oral placebo twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417164|NCT00573755|E1|Reported Event|Sorafenib Plus Aromatase Inhibitor|Patients receive oral sorafenib tosylate twice daily and oral letrozole, anastrozole, or exemestane once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
417165|NCT00573534|B1|Baseline|Group 1|
417166|NCT00573534|P1|Participant Flow|Group 1|
417167|NCT00573534|O1|Outcome|Lisdexamfetamine Plus Family Therapy|patients received lisdexamfetamine up to 70 mgs plus family counseling
417168|NCT00573534|O1|Outcome|Group 1|Lisdexamfetamine and family counseling
417169|NCT00573534|E1|Reported Event|Group 1|
417170|NCT00573508|B3|Baseline|Total|Total of all reporting groups
417171|NCT00573508|B2|Baseline|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417172|NCT00573508|B1|Baseline|Placebo|Matching placebo tablet taken once daily
417173|NCT00573508|P2|Participant Flow|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417174|NCT00573508|P1|Participant Flow|Placebo|Matching placebo tablet taken once daily
417175|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417176|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417177|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417178|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417179|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417180|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417181|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417182|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417183|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417184|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417185|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417186|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417187|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417188|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417189|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417190|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417191|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417192|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417193|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417194|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417195|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417196|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417197|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417198|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417199|NCT00573508|O2|Outcome|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417200|NCT00573508|O1|Outcome|Placebo|Matching placebo tablet taken once daily
417201|NCT00573508|E2|Reported Event|Solifenacin Succinate|5mg or 10mg tablet taken once daily
417202|NCT00573508|E1|Reported Event|Placebo|Matching placebo tablet taken once daily
417203|NCT00573469|B4|Baseline|Total|Total of all reporting groups
417204|NCT00573469|B3|Baseline|Placebo|An enteric capsule without D9421-C was given once daily.
417205|NCT00573469|B2|Baseline|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417206|NCT00573469|B1|Baseline|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417207|NCT00573469|P3|Participant Flow|Placebo|An enteric capsule without D9421-C was given once daily.
417208|NCT00573469|P2|Participant Flow|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417209|NCT00573469|P1|Participant Flow|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417210|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
417211|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417212|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417213|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
417214|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417215|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417216|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
417217|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
419764|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
417221|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417222|NCT00573469|O3|Outcome|Placebo|An enteric capsule without D9421-C was given once daily.
417223|NCT00573469|O2|Outcome|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417224|NCT00573469|O1|Outcome|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417225|NCT00573469|E3|Reported Event|Placebo|An enteric capsule without D9421-C was given once daily.
417226|NCT00573469|E2|Reported Event|D9421-C 15 mg|An enteric capsule including D9421-C 15 mg was given once daily.
417227|NCT00573469|E1|Reported Event|D9421-C 9 mg|An enteric capsule including D9421-C 9 mg was given once daily.
417228|NCT00573443|B4|Baseline|Total|Total of all reporting groups
417229|NCT00573443|B3|Baseline|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417230|NCT00573443|B2|Baseline|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417231|NCT00573443|B1|Baseline|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417232|NCT00573443|P3|Participant Flow|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417233|NCT00573443|P2|Participant Flow|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417234|NCT00573443|P1|Participant Flow|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417235|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417236|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417237|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417238|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417239|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417240|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417241|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417242|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417243|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417244|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417245|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
419765|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
417246|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417247|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417248|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417249|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417250|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417251|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417252|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417253|NCT00573443|O3|Outcome|Placebo|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417254|NCT00573443|O2|Outcome|AVP-923-20|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week OLE period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417255|NCT00573443|O1|Outcome|AVP-923-30|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period. Subjects who completed the DB period of this treatment arm could begin an optional 12 week open-label extension (OLE) period taking AVP-923 capsule containing 30 mg DM and 10 mg Q twice daily.
417256|NCT00573443|E4|Reported Event|AVP-923-30 (Open Label)|Optional 12-week Open Label phase for subjects who completed 12-week DB phase.
417257|NCT00573443|E3|Reported Event|Placebo (Double-blind)|Capsules containing placebo once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
417258|NCT00573443|E2|Reported Event|AVP-923-20 (Double-blind)|AVP-923 capsules containing 20 mg DM and 10 mg Q taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week DB period.
417259|NCT00573443|E1|Reported Event|AVP-923-30 (Double-blind)|AVP-923 capsules containing 30 mg dextromethorphan (DM) and 10 mg quinidine (Q) taken orally once daily for 1 week and twice daily for 11 additional consecutive weeks for a 12 week double-blind (DB) period.
417260|NCT00573430|B4|Baseline|Total|Total of all reporting groups
417261|NCT00573430|B3|Baseline|Candesartan 32mg|Candesartan 32mg oral once daily dose
417262|NCT00573430|B2|Baseline|Candesartan 16mg|Candesartan 16mg oral once daily dose
417263|NCT00573430|B1|Baseline|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417264|NCT00573430|P3|Participant Flow|Candesartan 32mg|Candesartan 32mg oral once daily dose
417265|NCT00573430|P2|Participant Flow|Candesartan 16mg|Candesartan 16mg oral once daily dose
417266|NCT00573430|P1|Participant Flow|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417267|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
417268|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
417269|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417270|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
417271|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
417272|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417273|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
417274|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
417275|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417276|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
417277|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
417278|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417279|NCT00573430|O3|Outcome|Candesartan 32mg|Candesartan 32mg oral once daily dose
417280|NCT00573430|O2|Outcome|Candesartan 16mg|Candesartan 16mg oral once daily dose
417281|NCT00573430|O1|Outcome|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417282|NCT00573430|E3|Reported Event|Candesartan 32mg|Candesartan 32mg oral once daily dose
417283|NCT00573430|E2|Reported Event|Candesartan 16mg|Candesartan 16mg oral once daily dose
417284|NCT00573430|E1|Reported Event|Candesartan 8 mg|Candesartan 8 mg oral once daily dose
417285|NCT00573391|B3|Baseline|Total|Total of all reporting groups
417286|NCT00573391|B2|Baseline|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
417287|NCT00573391|B1|Baseline|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
417288|NCT00573391|P2|Participant Flow|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
417289|NCT00573391|P1|Participant Flow|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
417290|NCT00573391|O2|Outcome|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
417291|NCT00573391|O1|Outcome|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
417292|NCT00573391|E2|Reported Event|VMD With Melphalan Dose Escalation|"VMD:~Velcade 1.3 mg/m^2 D1, 4, 7, 10 (x6 mo, then 1.0 mg/m^2) Melphalan 4 (6, 8, 10) mg/m^2 D1, 4, 7, 10 dose escalation Dexamethasone 20 mg 1-4 and 7-10"
417293|NCT00573391|E1|Reported Event|Velcade, Thalidomide, and Dexamethasone|Velcade 1.0 mg/m^2 Velcade 1.3 mg/m^2 D1,4, 8, 11 (x 6 cycles, then 1.0 mg/m^2 (for cycles 7-12) Thalidomide 100 mg D1-28 Dexamethasone 20 mg D1-4 and 8-11
417294|NCT00573313|B5|Baseline|Total|Total of all reporting groups
417295|NCT00573313|B4|Baseline|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
417296|NCT00573313|B3|Baseline|Lifestyle Counseling|Active drinkers non liver disease subjects
417297|NCT00573313|B2|Baseline|Healthy|Healthy subjects without alcoholism or liver disease.
417298|NCT00573313|B1|Baseline|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
417299|NCT00573313|P4|Participant Flow|Lifestyle Counseling|Subjects were enrolled into this arm for baseline measurements only.
417300|NCT00573313|P3|Participant Flow|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
417301|NCT00573313|P2|Participant Flow|Healthy|Subjects were enrolled into this arm for baseline measurement only.
417302|NCT00573313|P1|Participant Flow|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
417303|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving placebo sugar pill three times daily for 24 weeks.
417304|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
417305|NCT00573313|O2|Outcome|Sugar Pill|ALD subjects receiving Placebo three times daily for 24 weeks.
417306|NCT00573313|O1|Outcome|S-adenosylmethionine (SAMe)|Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks.
417307|NCT00573313|E2|Reported Event|Sugar Pill Placebo|The placebo group received a sugar pill identical in appearance that was taken three times daily.
417308|NCT00573313|E1|Reported Event|S-adenosylmethionine (SAMe) Treatment|The treatment group received S-adenosylmethionine (SAM) 400 mg three times daily.
417309|NCT00573287|B3|Baseline|Total|Total of all reporting groups
417310|NCT00573287|B2|Baseline|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
417311|NCT00573287|B1|Baseline|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
417312|NCT00573287|P2|Participant Flow|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
417313|NCT00573287|P1|Participant Flow|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
417314|NCT00573287|O2|Outcome|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
417315|NCT00573287|O1|Outcome|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
417316|NCT00573287|E2|Reported Event|Risperidone|risperidone: risperidone--tablets, 0.5-5.0mg daily for 24 weeks
417317|NCT00573287|E1|Reported Event|Clozapine|clozapine: clozapine--tablets, 12.5-100 mg, daily for 24 weeks
417318|NCT00573261|B3|Baseline|Total|Total of all reporting groups
417319|NCT00573261|B2|Baseline|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417320|NCT00573261|B1|Baseline|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417321|NCT00573261|P2|Participant Flow|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417322|NCT00573261|P1|Participant Flow|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417323|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417324|NCT00573261|O1|Outcome|Placebo|Placebo
417325|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417326|NCT00573261|O1|Outcome|Placebo|Placebo
417327|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417328|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417329|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417330|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417331|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417332|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417333|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417334|NCT00573261|O1|Outcome|Placebo|Placebo
417335|NCT00573261|O2|Outcome|Pregabalin|"Pregabalin~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417336|NCT00573261|O1|Outcome|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417337|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417338|NCT00573261|O1|Outcome|Placebo|Placebo
417339|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417340|NCT00573261|O1|Outcome|Placebo|Placebo
417341|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417342|NCT00573261|O1|Outcome|Placebo|Placebo
417343|NCT00573261|O2|Outcome|Pregabalin|Pregabalin
417344|NCT00573261|O1|Outcome|Placebo|Placebo
417345|NCT00573261|E2|Reported Event|Pregabalin|"Pregabalin medication~Pregabalin : Subjects will take pregabalin for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417346|NCT00573261|E1|Reported Event|Placebo|"Placebo~Placebo : Subjects will take placebo for the duration of four weeks. The dosage will range from 75 mg twice a day to 300 mg twice a day."
417347|NCT00573248|B3|Baseline|Total|Total of all reporting groups
417348|NCT00573248|B2|Baseline|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417349|NCT00573248|B1|Baseline|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417350|NCT00573248|P2|Participant Flow|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417351|NCT00573248|P1|Participant Flow|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417352|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
417353|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
417354|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
417355|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
417356|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
417357|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
417358|NCT00573248|O2|Outcome|Placebo Patches|Smokers and nonsmokers received placebo patches for two consecutive days.
417359|NCT00573248|O1|Outcome|Nicotine Patches|Smokers received 21 mg/day patches for two consecutive days and nonsmokers received 7 mg/day nicotine patches for two consecutive days.
417360|NCT00573248|E2|Reported Event|Nonsmokers|In a modified within-group cross-over, nonsmokers received 7 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417361|NCT00573248|E1|Reported Event|Smokers|In a modified within-group cross-over, smokers received 21 mg/day nicotine patches for two consecutive days and matching placebo patches for two consecutive days, with the order counterbalanced across participants.
417362|NCT00573183|B3|Baseline|Total|Total of all reporting groups
417363|NCT00573183|B2|Baseline|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
417364|NCT00573183|B1|Baseline|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
417365|NCT00573183|P2|Participant Flow|Treatment as Usual|Received standard care provided in intensive outpatient drug treatment program
417366|NCT00573183|P1|Participant Flow|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions in the standard intensive outpatient drug treatment program.
417367|NCT00573183|O2|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
417368|NCT00573183|O1|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
417369|NCT00573183|O2|Outcome|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
417370|NCT00573183|O1|Outcome|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
417371|NCT00573183|E2|Reported Event|Treatment as Usual|Standard treatment as usual in intensive outpatient substance abuse treatment program
417372|NCT00573183|E1|Reported Event|STAGE-12|Received 3 individual and 5 group sessions focusing on 12-step principles plus an intensive referral in which counselors linked participants to community-based 12-step volunteers. These sessions took the place of 3 individual and 5 group sessions.
417373|NCT00573170|B1|Baseline|All Study Participants Treated at Least Once|All study participants who were treated at least once with study medication
418523|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
417374|NCT00573170|P6|Participant Flow|Placebo, Butalbital-containing Combo. Medication, Treximet|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417375|NCT00573170|P5|Participant Flow|Placebo, Treximet, Butalbital-containing Combo. Medication|Matching placebo for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417376|NCT00573170|P4|Participant Flow|Butalbital-containing Combo. Medication, Placebo, Treximet|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417377|NCT00573170|P3|Participant Flow|Butalbital-containing Combo. Medication, Treximet, Placebo|Comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of first migraine attack, followed by a 7-day washout period; fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417378|NCT00573170|P2|Participant Flow|Treximet, Butalbital-containing Combo. Medication, Placebo|Fixed dose combination tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of second migraine attack, followed by a 7-day washout period; matching placebo for treatment of third migraine attack, followed by a 7-day washout period. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417379|NCT00573170|P1|Participant Flow|Treximet, Placebo, Butalbital-containing Combo. Medication|Fixed dose combination (combo.) tablet of sumatriptan succinate (equivalent to sumatriptan 85 milligrams [mg]) and naproxen sodium 500 mg (Treximet) for treatment of first migraine attack, followed by a 7-day washout period; matching placebo for treatment of second migraine attack, followed by a 7-day washout period; comparator of acetaminophen 325 mg, caffeine 40 mg, and butalbital 50 mg (butalbital-containing combination medication), currently marketed as Fioricet, for treatment of third migraine attack. Treatment of each separate migraine attack had to be preceeded by a 24-hour pain-free period to ensure that a separate migraine attack was being treated.
417380|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417381|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417382|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417383|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417384|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417385|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417386|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417387|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417388|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417389|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417390|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417391|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417392|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417393|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417394|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417395|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417396|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417397|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417398|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417399|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417400|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417401|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417402|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417403|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417404|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417405|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417406|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417407|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417408|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417409|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417410|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417411|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417412|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417413|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417414|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417415|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417416|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417417|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417418|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417419|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417420|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417421|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417422|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417423|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417424|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417425|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417426|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417427|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417428|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417429|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417430|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417431|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Butalbital-containing combination medication
417432|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with Treximet
417433|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 3 with placebo
417434|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Butalbital-containing combination medication
417435|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with Treximet
417436|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 2 with placebo
417437|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Butalbital-containing combination medication
417438|NCT00573170|O2|Outcome|Treximet|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with Treximet
417439|NCT00573170|O1|Outcome|Placebo|Participants taking any rescue medication within 48 hours of treating Migraine Attack 1 with placebo
417440|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417441|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417442|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417443|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417444|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417445|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417446|NCT00573170|O3|Outcome|Butalbital-containing Combination Medication|Attacks for which treatment of moderate or severe pain was Butalbital-containing combination medication
417447|NCT00573170|O2|Outcome|Treximet|Attacks for which treatment of moderate or severe pain was Treximet
417448|NCT00573170|O1|Outcome|Placebo|Attacks for which treatment of moderate or severe pain was placebo
417449|NCT00573170|E3|Reported Event|Butalbital-containing Combination Medication|Participants who reported an SAE anytime after initial treatment with blinded Butalbital-containing combination medication, but before another initial treatment with any other investigational product
417450|NCT00573170|E2|Reported Event|Treximet|Participants who reported an SAE anytime after initial treatment with blinded Treximet, but before another initial treatment with any other investigational product
417451|NCT00573170|E1|Reported Event|Placebo|Participants who reported an SAE anytime after initial treatment with blinded placebo, but before another initial treatment with any other investigational product
417452|NCT00573157|B3|Baseline|Total|Total of all reporting groups
417453|NCT00573157|B2|Baseline|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417454|NCT00573157|B1|Baseline|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417455|NCT00573157|P2|Participant Flow|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417456|NCT00573157|P1|Participant Flow|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered subcutaneously (SC) at a loading dose of 150 milligram (mg) twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose corticosteroids (CS) of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417457|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417458|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417459|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417460|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417461|NCT00573157|O2|Outcome|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417462|NCT00573157|O1|Outcome|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417497|NCT00572910|B1|Baseline|V710 (60 mcg / 60 mcg)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
417498|NCT00572910|P11|Participant Flow|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
417499|NCT00572910|P10|Participant Flow|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
418524|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
417463|NCT00573157|E2|Reported Event|Placebo Plus Mycophenolate Mofetil Plus Corticosteroids|Placebo was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417464|NCT00573157|E1|Reported Event|Atacicept Plus Mycophenolate Mofetil Plus Corticosteroids|Atacicept was administered SC at a loading dose of 150 mg twice weekly for 4 weeks followed by maintenance dose of 150 mg SC once weekly for 48 weeks. MMF was administered orally with a starting dose of 500 mg twice daily for 1 week, increased to 1000 mg twice daily for 1 week, then adjusted to 1500 mg or lower twice daily as per investigator’s discretion. High dose CS of 0.8 mg per kilogram per day or maximum of 60 mg per day prednisone or prednisone equivalent, whichever was less was administered for 4 Weeks and tapered to 7.5 to 10 mg/day up to Week 12.
417465|NCT00573144|B3|Baseline|Total|Total of all reporting groups
417466|NCT00573144|B2|Baseline|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
417467|NCT00573144|B1|Baseline|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
417468|NCT00573144|P2|Participant Flow|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
417469|NCT00573144|P1|Participant Flow|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
417470|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
417471|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
417472|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
417473|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
417474|NCT00573144|O2|Outcome|Nesiritide|"Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.~Nesiritide: Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min."
417475|NCT00573144|O1|Outcome|Placebo|"Infusion of 72 hours of saline solution (packaged to match active comparator).~Placebo: Infusion of 72 hours of saline solution (packaged to match active comparator)"
417476|NCT00573144|E2|Reported Event|Nesiritide|Infusion of 72 hours of IV nesiritide at 0.006 mcg/kg/min.
417477|NCT00573144|E1|Reported Event|Placebo|Infusion of 72 hours of saline solution (packaged to match active comparator).
417478|NCT00573131|B3|Baseline|Total|Total of all reporting groups
417479|NCT00573131|B2|Baseline|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417480|NCT00573131|B1|Baseline|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417481|NCT00573131|P2|Participant Flow|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417482|NCT00573131|P1|Participant Flow|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417483|NCT00573131|O2|Outcome|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417484|NCT00573131|O1|Outcome|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417485|NCT00573131|E2|Reported Event|Group 2|Radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417486|NCT00573131|E1|Reported Event|Group 1|OncoGel, radiation therapy and systemic chemotherapy (cisplatin plus 5-FU) prior to surgical resection.
417487|NCT00573066|B1|Baseline|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
417488|NCT00573066|P1|Participant Flow|Dexmedetomidine Dose Escalation Cohorts|"Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
417489|NCT00573066|O1|Outcome|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
417490|NCT00573066|E1|Reported Event|Dexmedetomidine, Infants, Cardiac Surgery|"Pharmacologic study of dexmedetomidine in infants following cardiac surgery Dexmedetomidine was administered to all subjects as an intravenous loading dose over 10 minutes followed by a continuous infusion for up to 24 hours.~Cohort 1--0.35mcg/kg loading dose, 0.25mcg/kg/hr infusion Cohort 2--0.7 mcg/kg loading dose, 0.5 mcg/kg/hr infusion Cohort 3--1 mcg/kg loading dose, 0.75 mcg/kg/hr infusion"
417491|NCT00572910|B7|Baseline|Total|Total of all reporting groups
417492|NCT00572910|B6|Baseline|Placebo (PBO / PBO)|Participants who were vaccinated with Placebo on Day 1 and Day 28.
417493|NCT00572910|B5|Baseline|V710 (90 mcg / 90 mcg) + MAA|Participants who were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
417494|NCT00572910|B4|Baseline|V710 (60 mcg / PBO) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28.
417495|NCT00572910|B3|Baseline|V710 (60 mcg / 60 mcg) + MAA|Participants who were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
417496|NCT00572910|B2|Baseline|V710 (60 mcg / PBO)|Participants who were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28.
418525|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
417500|NCT00572910|P9|Participant Flow|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
417501|NCT00572910|P8|Participant Flow|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
417502|NCT00572910|P7|Participant Flow|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
417503|NCT00572910|P6|Participant Flow|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg /PBO) with MAA.
417504|NCT00572910|P5|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
417505|NCT00572910|P4|Participant Flow|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
417506|NCT00572910|P3|Participant Flow|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
417507|NCT00572910|P2|Participant Flow|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
417508|NCT00572910|P1|Participant Flow|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
417509|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
417510|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
417511|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
417512|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
417513|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
417514|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
417515|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
417516|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
417517|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
417518|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
417519|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
417520|NCT00572910|O11|Outcome|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
417521|NCT00572910|O10|Outcome|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
417522|NCT00572910|O9|Outcome|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
417523|NCT00572910|O8|Outcome|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
417524|NCT00572910|O7|Outcome|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) with MAA.
417525|NCT00572910|O6|Outcome|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
417526|NCT00572910|O5|Outcome|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
417527|NCT00572910|O4|Outcome|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
417528|NCT00572910|O3|Outcome|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
417529|NCT00572910|O2|Outcome|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
417530|NCT00572910|O1|Outcome|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
417531|NCT00572910|O2|Outcome|V710 - Group 4|Participants in Group 4 were vaccinated V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
417532|NCT00572910|O1|Outcome|V710 - Group 2|Participants in Group 2 were vaccinated V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180.
417533|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
417534|NCT00572910|O2|Outcome|V710 - Group 3|Participants in Group 2 were vaccinated V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
417535|NCT00572910|O1|Outcome|V710 - Group 1|Participants in Group 1 were vaccinated V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
417536|NCT00572910|O3|Outcome|V710 - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.
417537|NCT00572910|O2|Outcome|V710 - Group 3 and 4|"Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants in Group 4 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
417538|NCT00572910|O1|Outcome|V710 - Group 1 and 2|"Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28 followed by third dose of V710 or placebo on Day 180.~Participants Group 2 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Placebo on Day 28 followed by third dose of V710 or placebo on Day 180."
417539|NCT00572910|O3|Outcome|V710 (90 mcg With MAA) - Group 5|Participants in Group 5 were vaccinated with V710 (90 mcg with MAA) on Day 1 and Day 28.
417540|NCT00572910|O2|Outcome|V710 (60 mcg With MAA) - Group 3|Participants in Group 3 were vaccinated with V710 (60 mcg with MAA) on Day 1 and Day 28.
417541|NCT00572910|O1|Outcome|V710 (60 mcg Without MAA) - Group 1|Participants in Group 1 were vaccinated with V710 (60 mcg without MAA) on Day 1 and Day 28.
417542|NCT00572910|E11|Reported Event|Placebo (PBO / PBO / PBO)|Participants in Group 6 who were vaccinated with Placebo (PBO / PBO / PBO).
417543|NCT00572910|E10|Reported Event|V710 (90 mcg / 90 mcg / PBO) + MAA|Participants in Group 5B who were vaccinated with V710 (90 mcg / 90 mcg / PBO) with MAA.
417544|NCT00572910|E9|Reported Event|V710 (90 mcg / 90 mcg / 90 mcg) + MAA|Participants in Group 5A who were vaccinated with V710 (90 mcg / 90 mcg / 90 mcg) with MAA.
417545|NCT00572910|E8|Reported Event|V710 (60 mcg / PBO / PBO) + MAA|Participants in Group 4B who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
417546|NCT00572910|E7|Reported Event|V710 (60 mcg / PBO / 60 mcg) + MAA|Participants in Group 4A who were vaccinated with V710 (60 mcg / PBO / PBO) with MAA.
417547|NCT00572910|E6|Reported Event|V710 (60 mcg / 60 mcg / PBO) + MAA|Participants in Group 3B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) with MAA.
417548|NCT00572910|E5|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg) + MAA|Participants in Group 3A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) with MAA.
417549|NCT00572910|E4|Reported Event|V710 (60 mcg / PBO / PBO)|Participants in Group 2B who were vaccinated with V710 (60 mcg / PBO / PBO) without MAA.
417550|NCT00572910|E3|Reported Event|V710 (60 mcg / PBO / 60 mcg)|Participants in Group 2A who were vaccinated with V710 (60 mcg / PBO / 60 mcg) without MAA.
417551|NCT00572910|E2|Reported Event|V710 (60 mcg / 60 mcg / PBO)|Participants in Group 1B who were vaccinated with V710 (60 mcg / 60 mcg / PBO) without MAA.
417552|NCT00572910|E1|Reported Event|V710 (60 mcg / 60 mcg / 60 mcg)|Participants in Group 1A who were vaccinated with V710 (60 mcg / 60 mcg / 60 mcg) without MAA.
417553|NCT00572897|B3|Baseline|Total|Total of all reporting groups
417554|NCT00572897|B2|Baseline|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417555|NCT00572897|B1|Baseline|Sibling Donor|Patients received a stem cell transplant from sibling
417556|NCT00572897|P2|Participant Flow|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417557|NCT00572897|P1|Participant Flow|Sibling Donor|Patients received a stem cell transplant from sibling
417558|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417559|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417560|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417561|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417562|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417563|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417564|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417565|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417566|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417567|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417568|NCT00572897|O2|Outcome|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417569|NCT00572897|O1|Outcome|Sibling Donor|Patients received a stem cell transplant from sibling
417570|NCT00572897|E2|Reported Event|Unrelated Donor|Patients received a stem cell transplant from an unrelated donor
417571|NCT00572897|E1|Reported Event|Sibling Donor|Patients received a stem cell transplant from sibling
417572|NCT00572832|B3|Baseline|Total|Total of all reporting groups
417573|NCT00572832|B2|Baseline|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
417574|NCT00572832|B1|Baseline|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
417575|NCT00572832|P2|Participant Flow|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
417576|NCT00572832|P1|Participant Flow|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
417577|NCT00572832|O2|Outcome|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
417578|NCT00572832|O1|Outcome|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
417579|NCT00572832|E2|Reported Event|12 Month Alternative Group|12 month Alternative Schedule Group with 3 doses of quadrivalent vaccine at 0, 2, and 12 months
417580|NCT00572832|E1|Reported Event|6 Month Standard Schedule|Receipt of three doses of quadrivalent human papillomavirus vaccine according to the regular schedule of 0,2, and 6 months.
417581|NCT00572728|B1|Baseline|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417582|NCT00572728|P1|Participant Flow|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417598|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417599|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417600|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417583|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417584|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417585|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~CT: Undergo 18F-FLT PET/CT~18F-FLT: Undergo 18F-FLT PET/CT~PET: Undergo 18F-FLT PET/CT"
417586|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417587|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417588|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417589|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post-NAC (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417590|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417591|NCT00572728|O1|Outcome|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417592|NCT00572728|E1|Reported Event|Diagnostic (18F-FLT)|"Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.~Fluorothymidine F-18: Undergo 18F-FLT PET/CT~Positron Emission Tomography: Undergo 18F-FLT PET/CT~Computed Tomography: Undergo 18F-FLT PET/CT~Laboratory Biomarker Analysis: Correlative studies"
417593|NCT00572572|B3|Baseline|Total|Total of all reporting groups
417594|NCT00572572|B2|Baseline|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
417595|NCT00572572|B1|Baseline|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
417596|NCT00572572|P2|Participant Flow|Arm B: Placebo, Then Aprepitant|"Participants first received matched placebo PO daily on days 3 through 7 during study cycle 1, then received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
417597|NCT00572572|P1|Participant Flow|Arm A: Aprepitant, Then Placebo|"Participants first received Aprepitant 125mg PO day 3 then 80mg on days 4 and 7 during study cycle 1, then received matched placebo PO daily on days 3 through 7 during study cycle 2~Aprepitant: Subjects will be randomized to receive aprepitant 125mg PO day 3 then 80mg on days 4-7 on either cycle 1 or cycle 2.~Placebo: Subjects will be randomized to receive placebo on days 3-7 on either cycle 1 or cycle 2."
417601|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417602|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417603|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417604|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417605|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417606|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417607|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417608|NCT00572572|O2|Outcome|Placebo|Placebo cycle whether placebo then aprepitant or aprepitant then placebo
417609|NCT00572572|O1|Outcome|Aprepitant|Aprepitant cycle whether aprepitant then placebo or placebo then aprepitant
417610|NCT00572572|E2|Reported Event|Placebo, Then Aprepitant.|"Arm A, Study Cycle 2~Arm B, Study Cycle 1~Placebo: Matched placebo PO daily on days 3 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 2~Arm B, Study Cycle 1"
417611|NCT00572572|E1|Reported Event|Aprepitant, Then Placebo|"Arm A, Study Cycle 1~Arm B, Study Cycle 2~Aprepitant: Aprepitant 125mg PO day 3 then 80mg on days 4 through 7~Subjects will be stratified prior to randomization based on previous administration of chemotherapy.~Subjects will randomize to aprepitant versus placebo with their first study cycle of chemotherapy and then cross over to opposite arm with the second study cycle.~Arm A, Study Cycle 1~Arm B, Study Cycle 2"
417612|NCT00572533|B3|Baseline|Total|Total of all reporting groups
417613|NCT00572533|B2|Baseline|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417614|NCT00572533|B1|Baseline|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417615|NCT00572533|P2|Participant Flow|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417616|NCT00572533|P1|Participant Flow|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417617|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417618|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417619|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417620|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417621|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417622|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417623|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417624|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417625|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417626|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417627|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417628|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417629|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417630|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417631|NCT00572533|O2|Outcome|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417632|NCT00572533|O1|Outcome|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417633|NCT00572533|E2|Reported Event|Treatment|"ESA Dose Adjustment per Smart Anemia Manager Algorithm"
417634|NCT00572533|E1|Reported Event|Control|ESA Dose Adjustment per standard Anemia Management Protocol
417635|NCT00572260|B1|Baseline|Antimicrobial Prophylaxis Administration With Daptomycin|
417636|NCT00572260|P1|Participant Flow|Antimicrobial Prophylaxis Administration With Daptomycin|
417637|NCT00572260|O1|Outcome|Patients Undergoing Cardiac Surgery|Patients undergoing cardiac valve replacement and coronary artery bypass grafting
417638|NCT00572260|E1|Reported Event|Antimicrobial Prophylaxis Administration With Daptomycin|
417639|NCT00572156|B5|Baseline|Total|Total of all reporting groups
417640|NCT00572156|B4|Baseline|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417641|NCT00572156|B3|Baseline|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417642|NCT00572156|B2|Baseline|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417643|NCT00572156|B1|Baseline|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417644|NCT00572156|P4|Participant Flow|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417645|NCT00572156|P3|Participant Flow|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417646|NCT00572156|P2|Participant Flow|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and Recombinant Human Insulin-Like Growth Factor-1 (rhIGF-1) (Mecasermin) 50µg/kg once daily injections
417647|NCT00572156|P1|Participant Flow|45 rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): Recombinant Human Growth Hormone (rhGH) (Somatropin) 45µg/kg once daily injection
417648|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417712|NCT00572117|O1|Outcome|Topiramate|Change in average number of drinks/heavy drinking day
420494|NCT00563368|E6|Reported Event|TPM 92 mg|92 mg topiramate
417649|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417650|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417651|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417652|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417653|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417654|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417655|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417656|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417657|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417658|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417659|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417660|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417661|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417662|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417663|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417664|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417665|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417666|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417667|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417668|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417669|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417670|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417671|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417672|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417673|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417674|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417675|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417676|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417677|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417678|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417679|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417680|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417681|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417682|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417683|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417684|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
418526|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
417685|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417686|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417687|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417688|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417689|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417690|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417691|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417692|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417693|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417694|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417695|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417696|NCT00572156|O4|Outcome|45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417697|NCT00572156|O3|Outcome|45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417698|NCT00572156|O2|Outcome|45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417699|NCT00572156|O1|Outcome|rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417700|NCT00572156|E4|Reported Event|4. 45 rhGH + 150 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 150µg/kg once daily injection
417701|NCT00572156|E3|Reported Event|3. 45 rhGH + 100 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH 45µg/kg and rhIGF-1 100µg/kg once daily injections
417702|NCT00572156|E2|Reported Event|2. 45 rhGH + 50 rhIGF-1|Increlex® (Mecasermin [rDNA origin] injection) + Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg and rhIGF-1 (Mecasermin) 50µg/kg once daily injections
417703|NCT00572156|E1|Reported Event|1. rhGH Alone|Nutropin AQ® (Somatropin [rDNA origin]): rhGH (Somatropin) 45µg/kg once daily injection
417704|NCT00572117|B3|Baseline|Total|Total of all reporting groups
417705|NCT00572117|B2|Baseline|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417706|NCT00572117|B1|Baseline|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417707|NCT00572117|P2|Participant Flow|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417708|NCT00572117|P1|Participant Flow|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417709|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in HAM-D score from baseline
417710|NCT00572117|O1|Outcome|Topiramate|Change in HAM-D score from baseline
417711|NCT00572117|O2|Outcome|Placebo (Inert Pill) Arm|Change in average number of drinks/heavy drinking day
417713|NCT00572117|E2|Reported Event|Placebo (Inert Pill) Arm|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. Subjects will receive placebo pills identical to the active pills (pills that contain the study drug, topiramate) for the 12 treatment weeks of the study and will have the pills discontinued over the next four weeks of the study. All subjects will be re-evaluated at 26 and 52 weeks.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417714|NCT00572117|E1|Reported Event|Topiramate|"Half the participants will receive topiramate and half will receive placebo. Neither participants nor study staff will know who is receiving which pills until the end of the study. The pills will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study.~Topiramate: Medication will be slowly increased over 5 weeks from 25 mg a day to 150 mg twice a day in an effort to minimize side effects that might enable participants and raters to guess whether they are on active drug or placebo. Subjects will continue on 150 mg twice a for Weeks 6-12 of the study."
417715|NCT00572039|B3|Baseline|Total|Total of all reporting groups
417716|NCT00572039|B2|Baseline|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
417717|NCT00572039|B1|Baseline|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
417718|NCT00572039|P2|Participant Flow|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
417719|NCT00572039|P1|Participant Flow|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
417720|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
417721|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
417722|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
417723|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
417724|NCT00572039|O2|Outcome|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
417725|NCT00572039|O1|Outcome|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
417726|NCT00572039|O2|Outcome|Supportive Therapy|"Supportive Therapy (ST)~ST: ST will be delivered in subjects' homes over the course of 6 weeks."
417727|NCT00572039|O1|Outcome|Problem Solving Treatment|"Problem Solving Treatment (PST)~PST: PST will be delivered in subjects' homes over the course of 6 weeks."
417728|NCT00572039|E2|Reported Event|Supportive Therapy|Supportive therapy is a structured, standardized, psychological treatment that controls for nonspecific treatment effects. Supportive therapy resembles PST in all ways but for PST’s problem-solving skills training. Both interventions are based on written treatment manuals and similar in dose and intensity of attention (number and duration of sessions). Supportive therapy is nondirective and supportive, facilitates personal expression, and conveys empathy, respect, and optimism (i.e., a general sense that things can get better). The ST therapist informs subjects that ST’s purpose is to explore the impact of vision loss on their lives.
417729|NCT00572039|E1|Reported Event|Problem Solving Treatment|Problem-solving therapy teaches problem solving skills in a structured way to enable a patient to systematically identify his or her problems, generate alternative solutions for each problem, select the best solution, develop and conduct a plan, and evaluate whether the problem is solved.
417730|NCT00571987|B1|Baseline|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
417731|NCT00571987|P1|Participant Flow|Subjects Received RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
417732|NCT00571987|O1|Outcome|Recurrences at the Site|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
417733|NCT00571987|O1|Outcome|Margin Status|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
417734|NCT00571987|E1|Reported Event|RFA Treatment|AngioDynamics (previously RITA Med,Inc) radiofrequency delivery system (consisting of a generator and Starburst XL probe): Generator is connected to a single use probe. Probe is inserted into the lumpectomy cavity and heated to 100 degrees Celsius and held there for 15 minutes, after which probe is removed.
417735|NCT00571974|B3|Baseline|Total|Total of all reporting groups
417736|NCT00571974|B2|Baseline|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
417737|NCT00571974|B1|Baseline|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
417738|NCT00571974|P2|Participant Flow|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
417739|NCT00571974|P1|Participant Flow|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
417740|NCT00571974|O1|Outcome|Phase II|Subjects treated with the MTD.
417741|NCT00571974|O1|Outcome|Phase I|Participants in the Phase I part of the study.
417742|NCT00571974|E2|Reported Event|Phase II|During Phase II, to assess the treatment efficacy of PDL-585 when used at the MTD in combination with 5-ALA applied topically to the premalignant lesion. Treatment efficacy will be assessed by means of the 90-day Objective Response rate observed among study subjects treated at the MTD.
417743|NCT00571974|E1|Reported Event|Phase I|"To determine the maximum tolerated energy density of the Pulse Dye Laser operated at 585 nm with a pulse time of 1.5 ms (PDL-585), when used in combination with 5-aminolevulinic acid (5-ALA) applied topically to the premalignant lesion.~The maximum tolerated energy density will be called the Maximum Tolerated Dose (MTD)."
417744|NCT00571961|B1|Baseline|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
417745|NCT00571961|P1|Participant Flow|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r once daily in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
417746|NCT00571961|O1|Outcome|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
417747|NCT00571961|E1|Reported Event|Lopinavir Coformulated With Ritonavir (LPV/r), 800mg/200mg|Subjects received 800mg/200mg of LPV/r in addition to BUP/NLX that the subjects were already being previously maintained on. These drugs were coadministered for a minimum of 10 days under direct observation.
417748|NCT00571948|B3|Baseline|Total|Total of all reporting groups
417749|NCT00571948|B2|Baseline|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
417750|NCT00571948|B1|Baseline|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
417751|NCT00571948|P2|Participant Flow|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
417752|NCT00571948|P1|Participant Flow|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
417753|NCT00571948|O2|Outcome|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
417754|NCT00571948|O1|Outcome|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
417755|NCT00571948|E2|Reported Event|Participants in the Intervention Group|Infants in the intervention group received vegetable-potato-meat-meals as part of complementary food containing higher amounts of meat than the control group and rapeseed oil instead of corn oil.
418527|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
417756|NCT00571948|E1|Reported Event|Participants in the Control Group|Infants in the control group received vegetable-potato-meat-meals as part of complementary food containing common amounts of meat and corn oil marketed in Germany.
417757|NCT00571922|B3|Baseline|Total|Total of all reporting groups
417758|NCT00571922|B2|Baseline|Placebo|placebo: matching placebo
417759|NCT00571922|B1|Baseline|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
417760|NCT00571922|P2|Participant Flow|Placebo|placebo: matching placebo
417761|NCT00571922|P1|Participant Flow|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
417762|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
417763|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
417764|NCT00571922|O2|Outcome|Placebo|placebo: matching placebo
417765|NCT00571922|O1|Outcome|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
417766|NCT00571922|E2|Reported Event|Placebo|placebo: matching placebo
417767|NCT00571922|E1|Reported Event|Acamprosate|Acamprosate: 2 gr/day (333 mg, TID)
417768|NCT00571662|B1|Baseline|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417769|NCT00571662|P1|Participant Flow|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417770|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417771|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417772|NCT00571662|O1|Outcome|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417773|NCT00571662|E1|Reported Event|Cohort I|Pentostatin to be administered intravenously on days -10, -9, and -8 at a dose of 4mg/m2/day
417774|NCT00571649|B3|Baseline|Total|Total of all reporting groups
417775|NCT00571649|B2|Baseline|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days (SAF population)
417776|NCT00571649|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days (SAF population)
417777|NCT00571649|P2|Participant Flow|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days during treatment period
417778|NCT00571649|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days during treatment period
417779|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417780|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417781|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417782|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417783|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417784|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417785|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417786|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417787|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417788|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417789|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417790|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417791|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417792|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417793|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417794|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417795|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417796|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417797|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417798|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417799|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417800|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417801|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417802|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417803|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417804|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417805|NCT00571649|O2|Outcome|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417806|NCT00571649|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417807|NCT00571649|E2|Reported Event|Enoxaparin|Participants received oral rivaroxaban-matched placebo tablet OD for 35 +/- 4 days, plus 40 mg subcutaneous enoxaparin solution OD for 10 +/- 4 days
417808|NCT00571649|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 10 mg oral rivaroxaban tablet once daily (OD) for 35 +/- 4 days, plus subcutaneous enoxaparin-matched placebo solution OD for 10 +/- 4 days
417809|NCT00571428|B3|Baseline|Total|Total of all reporting groups
417810|NCT00571428|B2|Baseline|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
417811|NCT00571428|B1|Baseline|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
417812|NCT00571428|P2|Participant Flow|30 Mcg QD / 15 Mcg BID|Arformoterol 30 mcg once a day (morning) and placebo (evening) for one visit followed by Arformoterol 15 mcg twice a day (morning and evening) for the next visit.
417813|NCT00571428|P1|Participant Flow|15 Mcg BID / 30 Mcg QD|Arformoterol 15 mcg twice a day (morning and evening) for one visit followed by Arformoterol 30 mcg once a day (morning) and placebo (evening) for the next visit.
417814|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417815|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417816|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417817|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417818|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417819|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417820|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417821|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417822|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417823|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417824|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417825|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417826|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417827|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417828|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417829|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417830|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417831|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417832|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417833|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417834|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417835|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417836|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417837|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417838|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417839|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417840|NCT00571428|O2|Outcome|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417841|NCT00571428|O1|Outcome|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417842|NCT00571428|E2|Reported Event|30 Mcg QD|Arformoterol 30 mcg once a day (morning) and placebo (evening)
417843|NCT00571428|E1|Reported Event|15 Mcg BID|Arformoterol 15 mcg twice a day (morning and evening)
417844|NCT00571324|B1|Baseline|Subject Population|All subjects enrolled and treated in the protocol served as their own control. Because of this and the small sample size, baseline characteristic data is presented together.
417910|NCT00570960|P1|Participant Flow|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
417845|NCT00571324|P2|Participant Flow|Vehicle First, Then Exendin-(9-39)|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours. The following day, after another overnight fast, Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. During both infusions, blood glucose levels were measured every 20 minutes.
417846|NCT00571324|P1|Participant Flow|Exendin-(9-39) First, the Vehicle|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion. The following day, after another overnight fast, normal saline (control) vehicle infusion was administered intravenously (IV) over 6 hours. During both infusions, blood glucose levels were measured every 20 minutes.
417847|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
417848|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
417849|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
417850|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
417851|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
417852|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
417853|NCT00571324|O2|Outcome|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
417854|NCT00571324|O1|Outcome|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
417855|NCT00571324|E2|Reported Event|Vehicle|Normal saline vehicle infusion was administered intravenously (IV) after an overnight fast. The infusion was given over 6 hours.
417856|NCT00571324|E1|Reported Event|Exendin-(9-39)|Exendin-(9-39) was administered intravenously (IV) after an overnight fast. Exendin-(9-39) was infused over 6 hours with the dose slowly escalating from 100pmol/kg/min for 2 hours, then 300pmol/kg/min for another 2 hours followed by 500pmol/kg/min for the last 2 hours of the infusion.
417857|NCT00571038|B3|Baseline|Total|Total of all reporting groups
417858|NCT00571038|B2|Baseline|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417859|NCT00571038|B1|Baseline|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417860|NCT00571038|P2|Participant Flow|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417861|NCT00571038|P1|Participant Flow|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417862|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417863|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417864|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417865|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417866|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417867|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
418528|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
417868|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417869|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417870|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417871|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417872|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417873|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417874|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417875|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417876|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417877|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417878|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417879|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417880|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417881|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417882|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417883|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417884|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417885|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417886|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417887|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417911|NCT00570960|O2|Outcome|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
417888|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417889|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417890|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417891|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417892|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417893|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417894|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417895|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417896|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417897|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417898|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417899|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417900|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417901|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417902|NCT00571038|O2|Outcome|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417903|NCT00571038|O1|Outcome|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417904|NCT00571038|E2|Reported Event|Seminar|Post provided with blood pressure cuffs, pedometers and scale. Post members, including study participants invited to didactic sessions on cardiovascular health. Two or more post representatives (who were also post members) coordinated use of equipment and encouraged members to attend the didactic sessions.
417905|NCT00571038|E1|Reported Event|Peer Led|Post provided with blood pressure cuffs, pedometers and scale. Two post members trained as peer leaders who encourage post members to take positive steps to improve BP. Peer leader training involves 20 hours of training over 12 months, telephone/email access to clinical experts and educational materials to share with post members.
417906|NCT00570960|B3|Baseline|Total|Total of all reporting groups
417907|NCT00570960|B2|Baseline|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
417908|NCT00570960|B1|Baseline|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
417909|NCT00570960|P2|Participant Flow|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
417912|NCT00570960|O1|Outcome|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
417913|NCT00570960|E2|Reported Event|Standard of Care Albumin Arm|"antibiotic therapy in addition to human albumin, 1.5 g/kg on day one and 1.0 g/kg on day three~human albumin : human albumin 1.5 g/kg on day one and 1.0 g/kg on day three"
417914|NCT00570960|E1|Reported Event|Dextran Therapy Arm|"antibiotic therapy in addition to dextran 70, 1.0 g/kg on days one, two and three~Dextran 70 : dextran 70, 1.0 g/kg on days one, two and three"
417915|NCT00570921|B1|Baseline|Fulvestrant & Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that.~Everolimus: Everolimus tablets, two-5 mg tablets a day~Fulvestrant: intramuscular, 500 mg in two divided doses- one on each side- on day 1, then 250mg on day 14, then 250 mg on day 28 and every 4 weeks +/- 3 days thereafter"
417916|NCT00570921|P1|Participant Flow|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
417917|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
417918|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
417919|NCT00570921|O1|Outcome|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
417920|NCT00570921|E1|Reported Event|Fulvestrant + Everolimus|"Fulvestrant + Everolimus~Fulvestrant was administered intramuscularly (in the gluteus maximus) in a loading dose schedule as follows: 500 mg in two divided doses—one on each side on day 1, then 250 mg on day 14, and then 250 mg on day 28 and every 4 weeks ± 3 days thereafter. Everolimus was administered initially at a dose of 5 mg daily in the first 5-patient cohort for the first month of treatment and then increased to 10 mg PO daily after that."
417921|NCT00570908|B1|Baseline|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
417922|NCT00570908|P1|Participant Flow|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
417923|NCT00570908|O1|Outcome|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
417924|NCT00570908|E1|Reported Event|WBRT + Capecitabine + Sunitinib|capecitabine concurrently with WBRT(Whole Brain Radiotherapy 30 Gy in 10 fractions) followed by combination capecitabine with sunitinib(Sutent)
417925|NCT00570778|B1|Baseline|Overall Population|Participants were randomized and received the following 4 treatments: 1-Two placebo capsules inhaled once daily via a SDDPI for 7 days, 2-One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days, 3-One Indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days and 4-Two Indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days. There was a 7 day washout period between the four treatment periods.
417926|NCT00570778|P4|Participant Flow|D: Placebo- Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg|"Treatment Period 1: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days."
417927|NCT00570778|P3|Participant Flow|C: Ind/Glyc 300/50 μg- Ind 300 μg- Ind 600 μg- Placebo|"Treatment Period 1: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: Two placebo capsules inhaled once daily via a SDDPI for 7 days."
417928|NCT00570778|P2|Participant Flow|B: Ind 600 μg- Placebo- Ind/Glyc 300/50 μg- Ind 300 μg|"Treatment Period 1: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 2: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a SDDPI for 7 days."
417929|NCT00570778|P1|Participant Flow|A: Ind 300 μg- Ind 600 μg- Placebo- Ind/Glyc 300/50 μg|"Treatment Period 1: One indacaterol (Ind) 300 μg capsule and one placebo capsule inhaled once daily via a single dose dry powder inhaler (SDDPI) for 7 days.~Treatment Period 2: Two indacaterol 300 μg capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 3: Two placebo capsules inhaled once daily via a SDDPI for 7 days.~Treatment Period 4: One indacaterol/glycopyrrolate (Ind/Glyc) 300/50 μg and one placebo capsule inhaled once daily via a SDDPI for 7 days."
417930|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
420495|NCT00563368|E5|Reported Event|PHEN 15 mg|15 mg phentermine
417931|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417932|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417933|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417934|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417935|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417936|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417937|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417938|NCT00570778|O4|Outcome|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417939|NCT00570778|O3|Outcome|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417940|NCT00570778|O2|Outcome|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417941|NCT00570778|O1|Outcome|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300/50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417942|NCT00570778|E4|Reported Event|Placebo|Two placebo capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417943|NCT00570778|E3|Reported Event|Indacaterol 600 μg|Two indacaterol 300 μg capsules inhaled once daily via a single dose dry powder inhaler for 7 days.
417944|NCT00570778|E2|Reported Event|Indacaterol 300 μg|One capsule indacaterol 300 μg + one placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417945|NCT00570778|E1|Reported Event|Indacaterol/Glycopyrrolate 300/50 μg|One indacaterol/glycopyrrolate 300 μg /50 μg capsule + 1 placebo capsule inhaled once daily via a single dose dry powder inhaler for 7 days.
417946|NCT00570765|B4|Baseline|Total|Total of all reporting groups
417947|NCT00570765|B3|Baseline|Placebo|Placebo by mouth, daily
417948|NCT00570765|B2|Baseline|50 mg|INT-747 50 mg by mouth, daily
417949|NCT00570765|B1|Baseline|10 mg|INT-747 10 mg by mouth, daily
417950|NCT00570765|P3|Participant Flow|Placebo|Placebo by mouth, daily
417951|NCT00570765|P2|Participant Flow|50 mg|INT-747 50 mg by mouth, daily
417952|NCT00570765|P1|Participant Flow|10 mg|INT-747 10 mg by mouth, daily
417953|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
417954|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
417955|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
417956|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
417957|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
417958|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
417959|NCT00570765|O3|Outcome|Placebo|Placebo by mouth, daily
417960|NCT00570765|O2|Outcome|50 mg|INT-747 50 mg by mouth, daily
417961|NCT00570765|O1|Outcome|10 mg|INT-747 10 mg by mouth, daily
417962|NCT00570765|E3|Reported Event|Placebo|Placebo by mouth, daily
417963|NCT00570765|E2|Reported Event|50 mg|INT-747 50 mg by mouth, daily
417964|NCT00570765|E1|Reported Event|10 mg|INT-747 10 mg by mouth, daily
417965|NCT00570739|B5|Baseline|Total|Total of all reporting groups
417966|NCT00570739|B4|Baseline|Pre-diabetic Group: Colesevelam|This group received 6 colesevelam tablets, 625mg, once per day for 16 weeks.
417967|NCT00570739|B3|Baseline|Pre-diabetic Group: Placebo|This group received 6 colesevelam matching placebo tablets once per day for 16 weeks
417968|NCT00570739|B2|Baseline|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
417969|NCT00570739|B1|Baseline|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
417970|NCT00570739|P4|Participant Flow|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
417971|NCT00570739|P3|Participant Flow|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
417972|NCT00570739|P2|Participant Flow|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
417973|NCT00570739|P1|Participant Flow|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
417974|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417975|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417976|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417977|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417978|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417979|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418529|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
417980|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417981|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417982|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417983|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417984|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417985|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417986|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417987|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417988|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417989|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417990|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417991|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417992|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417993|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417994|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417995|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417996|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417997|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
417998|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
417999|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418000|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418001|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418002|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418003|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418004|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418005|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418006|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418007|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418008|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418009|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418010|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418011|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418012|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418013|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418014|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418015|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418016|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418017|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418018|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418019|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418020|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418021|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418022|NCT00570739|O4|Outcome|Pre-Diabetes Group: Colesevelam (LOCF)|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418023|NCT00570739|O3|Outcome|Pre-Diabetes Group: Placebo (LOCF)|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418024|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418025|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418026|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418027|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418028|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418029|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418030|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418031|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418032|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418033|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418034|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418035|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418036|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418037|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418038|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418039|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418040|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418041|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418042|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg once daily. The total treatment duration was 16 weeks.
418043|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The total treatment duration was 16 weeks.
418044|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418045|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418046|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418047|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418048|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418049|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418050|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418051|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418052|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418053|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418054|NCT00570739|O2|Outcome|Pre-Diabetes Group: Colesevelam|This group received 6 colesevelam tablets 625 mg/day. The treatment duration was 16 weeks.
418055|NCT00570739|O1|Outcome|Pre-Diabetes Group: Placebo|This group received 6 matching colesevelam placebo tablets/day. The treatment duration was 16 weeks.
418056|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418057|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418058|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418059|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418060|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418061|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418062|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418063|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418064|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418065|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418066|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418067|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418068|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418069|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418070|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418071|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418072|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418073|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418074|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418075|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418076|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418077|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418078|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418079|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418080|NCT00570739|O4|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin for 16 Weeks(LOCF)|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418081|NCT00570739|O3|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks (LOCF)|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418082|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin for 16 Weeks|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418083|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin for 16 Weeks|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418155|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418084|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418085|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418086|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418087|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418088|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418089|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418090|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418091|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418092|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418093|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418094|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418095|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418096|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418097|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418098|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418099|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418100|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418101|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418102|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418103|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418104|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418105|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418106|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418107|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418108|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The treatment duration was 16 weeks.
418109|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The treatment duration was 16 weeks.
418110|NCT00570739|O2|Outcome|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418111|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418112|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418113|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418114|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418115|NCT00570739|O1|Outcome|Type 2 Diabetes Group: Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418116|NCT00570739|O2|Outcome|Type 2 Diabetes Group:Colesevelam+Metformin|This group received 6 colesevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. The total treatment duration was 16 weeks.
418117|NCT00570739|O1|Outcome|Type 2 Diabetes Group:Placebo+Metformin|This group received 6 matching colesevelam placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. The total treatment duration was 16 weeks.
418118|NCT00570739|E4|Reported Event|Pre-diabetic Group: Colesevelam|This group was given 6 colesevelam tablets, 625mg, once a day. This treatment duration was 16 weeks.
418119|NCT00570739|E3|Reported Event|Pre-diabetic Group: Placebo|This group was given 6 placebo tablets once a day. They matched the colesevelam tablets. This treatment duration was 16 weeks.
418120|NCT00570739|E2|Reported Event|Type 2 Diabetes Group: Colesevelam + Metformin|This group received 6 colevevelam tablets 625 mg once daily + open-label metformin once a day. The dose of metformin depended on the participant's tolerance for the drug. This treatment duration was 16 weeks.
418121|NCT00570739|E1|Reported Event|Type 2 Diabetes Group: Placebo + Metformin|This group received 6 matching colesevalm placebo tablets/day + open-label metformin. The dose of metformin depended on the participant's tolerability. This treatment duration was 16 weeks.
418122|NCT00570713|B3|Baseline|Total|Total of all reporting groups
418123|NCT00570713|B2|Baseline|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418124|NCT00570713|B1|Baseline|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418125|NCT00570713|P2|Participant Flow|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418126|NCT00570713|P1|Participant Flow|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418127|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418128|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418129|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418156|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418157|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418130|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418131|NCT00570713|O2|Outcome|Placebo Plus Gemcitabine ('Placebo')|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418132|NCT00570713|O1|Outcome|MORAb-009 Plus Gemcitabine ('MORAb-009')|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418133|NCT00570713|E2|Reported Event|Placebo Plus Gemcitabine (‘Placebo’)|Placebo was administered on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418134|NCT00570713|E1|Reported Event|MORAb-009 Plus Gemcitabine (‘MORAb-009’)|MORAb-009 was administered at 5 mg/kg on Day 1 of Weeks 1 through 7 during the first cycle and on Day 1 of Weeks 1 through 3 of subsequent cycles. Gemcitabine was administered by i.v. infusion at an initial dose of 1000 mg/m2 once weekly for up to 7 weeks (or until toxicity necessitated reducing or holding a dose), followed by a week of rest from treatment. Subsequent cycles consisted of infusions once weekly for 3 consecutive weeks, followed by a week of rest from treatment.
418135|NCT00570687|B3|Baseline|Total|Total of all reporting groups
418136|NCT00570687|B2|Baseline|Original Protocol|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418137|NCT00570687|B1|Baseline|Amendment 1|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418138|NCT00570687|P10|Participant Flow|Original Protocol: Insulin Lispro to Exubera to TI|12 U of subcutaneously administered insulin lispro, followed by 4 mg of Exubera administered via inhalation, and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
418139|NCT00570687|P9|Participant Flow|Original Protocol: Insulin Lispro to TI to Exubera|12 U of subcutaneously administered insulin lispro, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, and then 4 mg of Exubera administered via inhalation
418140|NCT00570687|P8|Participant Flow|Original Protocol: Exubera to TI to Insulin Lispro|4 mg of Exubera administered via inhalation, followed by 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler,. and then 12 U of subcutaneously administered insulin lispro
418141|NCT00570687|P7|Participant Flow|Original Protocol: Exubera to Insulin Lispro to TI|4 mg of Exubera administered via inhalation, followed by 12 U of subcutaneously administered insulin lispro,and then 45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
418142|NCT00570687|P6|Participant Flow|Original Protocol: TI to Exubera to Insulin Lispro|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 4 mg of Exubera administered via inhalation, and then 12 U of subcutaneously administered insulin lispro
418143|NCT00570687|P5|Participant Flow|Original Protocol: TI to Insulin Lispro to Exubera|45 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 12 U of subcutaneously administered insulin lispro, and then 4 mg of Exubera administered via inhalation
418144|NCT00570687|P4|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 90 U TI|10 U subcutaneously administered insulin lispro, followed by 90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
418145|NCT00570687|P3|Participant Flow|Amendment 1: TI 90 U Then 10 U Insulin Lispro|90 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
418146|NCT00570687|P2|Participant Flow|Amendment 1: 10 U Insulin Lispro Then 60 U TI|10 U subcutaneously administered insulin lispro, followed by 60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler
418147|NCT00570687|P1|Participant Flow|Amendment 1: TI 60 U Then Insulin Lispro 10 U|60 U of Technosphere Insulin (TI) administered via inhalation using MedTone inhaler, followed by 10 U subcutaneously administered insulin lispro
418148|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418149|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418150|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418151|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418152|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418153|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418154|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418530|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418158|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418159|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418160|NCT00570687|O6|Outcome|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418161|NCT00570687|O5|Outcome|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418162|NCT00570687|O4|Outcome|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418163|NCT00570687|O3|Outcome|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418164|NCT00570687|O2|Outcome|Amendment 1 - TI Inhalation Powder 60U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418165|NCT00570687|O1|Outcome|Amendment 1 - TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418166|NCT00570687|E6|Reported Event|Original Protocol - Insulin Lispro 12 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418167|NCT00570687|E5|Reported Event|Original Protocol - Exubera 4 mg|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418168|NCT00570687|E4|Reported Event|Original Protocol - TI Inhalation Powder 45 U|3-way crossover study of 45 U of Technosphere Insulin Inhalation Powder, 4 mg of Exubera, and 12 U of subcutaneous insulin lispro
418169|NCT00570687|E3|Reported Event|Amendment 1 - Insulin Lispro 10 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418170|NCT00570687|E2|Reported Event|Amendment 1 - TI Inhalation Powder 60 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418171|NCT00570687|E1|Reported Event|Amendment 1 -TI Inhalation Powder 90 U|2-way crossover study of 60 U or 90 U of Technosphere Insulin Inhalation Powder crossed with 10 U of subcutaneous insulin lispro
418172|NCT00570674|B1|Baseline|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418173|NCT00570674|P7|Participant Flow|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418174|NCT00570674|P6|Participant Flow|Phase I Dose Level 4 Expansion Cohort: AC-RT|"Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.~If no DLTs are observed at dose level 4 then ten additional participants (expansion cohort) will be enrolled at that dose level."
418175|NCT00570674|P5|Participant Flow|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418176|NCT00570674|P4|Participant Flow|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418177|NCT00570674|P3|Participant Flow|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418178|NCT00570674|P2|Participant Flow|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418179|NCT00570674|P1|Participant Flow|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418180|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418300|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
418181|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418182|NCT00570674|O1|Outcome|All Phase II Participants|Participants received Abraxane according to the established recommended Phase II dose of Abraxane (50mg/m2 IV) then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418183|NCT00570674|O5|Outcome|Phase I Dose Level 4: AC-RT|Phase I Dose Level 4 participants received Abraxane 50mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418184|NCT00570674|O4|Outcome|Phase I Dose Level 3: AC-RT|Phase I Dose Level 3 participants received Abraxane 40mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418185|NCT00570674|O3|Outcome|Phase I Dose Level 2: AC-RT|Phase I Dose Level 2 participants received Abraxane 30mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418186|NCT00570674|O2|Outcome|Phase I Dose Level -1: AC-RT|Phase I Dose Level -1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 weekly IV during the period of radiotherapy for a total of 7 weeks. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418187|NCT00570674|O1|Outcome|Phase I Dose Level 1: ACE-RT|Phase I Dose Level 1 participants received Abraxane 20mg/m2 IV then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. One dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418188|NCT00570674|O1|Outcome|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418189|NCT00570674|E1|Reported Event|All Phase I Participants|Participants received Abraxane according to the established dose escalation schedule then carboplatin AUC 1.5 IV weekly during the period of radiotherapy for a total of 7 weeks. For Dose Level 1 participants, one dose (400 mg/m2 IV) of Erbitux was given prior to start of radiation, then weekly at 250 mg/m2 IV. Intensity-modulated radiotherapy (IMRT) was delivered 5 days per week with the prescribed dose of 70 Gy to the gross tumor volume, given in 2 Gy daily fractions for a total of 35 fractions.
418190|NCT00570531|B1|Baseline|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418191|NCT00570531|P1|Participant Flow|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418192|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418216|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418193|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418194|NCT00570531|O1|Outcome|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418195|NCT00570531|E1|Reported Event|Bevacizumab|"Bevacizumab: Pre-Operative Treatment: Bevacizumab will be given over 60-90 minutes through an I.V. catheter on days 2 and 16. Post-Operative Treatment:Bevacizumab given over 60-90 minutes through an I.V. catheter every 21 days for 12 months, starting 6-8 weeks after surgery.~Paclitaxel: Pre-Operative Chemotherapy treatment: Paclitaxel 45 mg/m^2 will be administered as a 1-hour intravenous infusion on days 2, 9, 16, 23, and 30. It will be given before cisplatin administration.~Cisplatin: Pre-Operative Chemotherapy Treatment: Cisplatin 30 mg/m^2 over 1 hour on days 2, 9, 16, 23, and 30. It will be given after paclitaxel.~5-Fluorouracil: Pre-Operative Chemotherapy Treatment: 5-Fluorouracil at 200 mg/m2/day will be given as a continuous intravenous infusion on days #2-33.~Radiation Therapy: Pre-Operative Treatment: Radiotherapy will be given Monday through Friday five days a week on days 1-5, 8-12, 15-19, 22-26, and 29-33. Radiotherapy will be administered using MV x-rays."
418196|NCT00570505|B1|Baseline|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
418197|NCT00570505|P1|Participant Flow|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418198|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418199|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418200|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418201|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418202|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418203|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418204|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418205|NCT00570505|O1|Outcome|LapBand|"All subjects who receive the LAP-BAND System.~LAP-BAND System: Reduction of food intake due to creation of smaller stomach pouch"
418206|NCT00570505|E1|Reported Event|LapBand|Subjects implanted with the LapBand(R) Adjustable Gastric Band System
418207|NCT00570492|B3|Baseline|Total|Total of all reporting groups
418208|NCT00570492|B2|Baseline|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418209|NCT00570492|B1|Baseline|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418210|NCT00570492|P3|Participant Flow|FFNS 110 mcg: Double-blind Treatment Period|Participants were randomized to receive fluticasone furoate nasal spray (FFNS) 110 micrograms (mcg) OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
418211|NCT00570492|P2|Participant Flow|Placebo: Double-blind Treatment Period|Participants were randomized to receive matching placebo nasal spray OD as 2 sprays per nostril during the 52-week Double-blind Treatment Period
418212|NCT00570492|P1|Participant Flow|Placebo: Baseline Period|Placebo nasal spray administered once daily (OD) as 2 sprays per nostril to all enrolled participants during the 16-week Single-blind Baseline period, to assess the baseline growth velocity
418213|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418214|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418215|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
420499|NCT00563368|E1|Reported Event|Placebo|Placebo
418217|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418218|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418219|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418220|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418221|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418222|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418223|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418224|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418225|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418226|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418227|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418228|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418229|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418230|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418231|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418232|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418233|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418234|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418235|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418236|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418237|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418299|NCT00570141|P1|Participant Flow|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
421035|NCT00561652|B1|Baseline|Arm 1|Education plus exercise
418238|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418239|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418240|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418241|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418242|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418243|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418244|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418245|NCT00570492|O2|Outcome|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418246|NCT00570492|O1|Outcome|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418247|NCT00570492|E2|Reported Event|FFNS 110 mcg|Participants received placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, and then received FFNS 110 mcg OD in the following 52-week Double-blind Treatment Period. Participants again received placebo nasal spray OD in the 8-week Single-blind Follow-up Period.
418248|NCT00570492|E1|Reported Event|Placebo|Participants received matching placebo nasal spray OD (as 2 sprays per nostril at each time point) in the 16-week Single-blind Baseline Period, in the following 52-week Double-blind Treatment Period (after randomization), and then in the 8-week Single-blind Follow-up Period.
418249|NCT00570401|B1|Baseline|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
418250|NCT00570401|P1|Participant Flow|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
418251|NCT00570401|O1|Outcome|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
418252|NCT00570401|E1|Reported Event|Dasatinib|Dasatinib in Patients with Lung Adenocarcinoma Receiving Erlotinib with Acquired Resistance to EGFR Tyrosine Kinase Inhibitors (TKIs)
418253|NCT00570362|B3|Baseline|Total|Total of all reporting groups
418254|NCT00570362|B2|Baseline|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
418255|NCT00570362|B1|Baseline|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
418256|NCT00570362|P2|Participant Flow|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
418257|NCT00570362|P1|Participant Flow|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
418258|NCT00570362|O2|Outcome|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
418259|NCT00570362|O1|Outcome|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
418260|NCT00570362|E2|Reported Event|Control Group|The control group was recruited from other age-gender-matched volunteers, and it was composed of subjects who had never neither glaucoma nor other ocular diseases such as cataract, diabetic ratinopathy, or age related macular degeneration.
418531|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418261|NCT00570362|E1|Reported Event|Normal Tension Glaucoma Group|Patients were diagnosed as having normal tension glaucoma if IOP measurements were lesser than 22 mm Hg by Goldmann applanation tonometry, characteristic glaucomatous cupping of the optic disc on fundoscopic examination, normal open anterior chamber angles by gonioscopy, and repeatable visual field defects consistent with the diagnosis of glaucoma, according to results obtained with program 24-2 of the Humphrey Field Analyzer (Carl Zeiss Meditec, Dublin, CA).
418262|NCT00570349|B4|Baseline|Total|Total of all reporting groups
418263|NCT00570349|B3|Baseline|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418264|NCT00570349|B2|Baseline|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418265|NCT00570349|B1|Baseline|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418266|NCT00570349|P3|Participant Flow|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418267|NCT00570349|P2|Participant Flow|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418268|NCT00570349|P1|Participant Flow|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418269|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418270|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418271|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418272|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418273|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418274|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418275|NCT00570349|O3|Outcome|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418276|NCT00570349|O2|Outcome|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418277|NCT00570349|O1|Outcome|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418278|NCT00570349|E3|Reported Event|Nitrogen|Nitrogen (Placebo) administered at 20 ppm or 40 ppm via nasal cannula over a 44 hour period
418279|NCT00570349|E2|Reported Event|Inhaled Nitric Oxide High Dose|High dose group received Inhaled Nitric Oxide at 40 ppm via nasal cannula for 44 hours.
418280|NCT00570349|E1|Reported Event|Inhaled Nitric Oxide Low Dose|Low dose group received Inhaled Nitric Oxide at 20 parts per million (ppm) via nasal cannula for 44 hours
418281|NCT00570310|B3|Baseline|Total|Total of all reporting groups
418282|NCT00570310|B2|Baseline|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418283|NCT00570310|B1|Baseline|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418284|NCT00570310|P2|Participant Flow|Placebo|Patients were treated with placebo starting at randomization.
418285|NCT00570310|P1|Participant Flow|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
418286|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418287|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418288|NCT00570310|O2|Outcome|Placebo|Patients who were randomized to placebo and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418289|NCT00570310|O1|Outcome|Pregabalin|Patients who were randomized to pregabalin and were categorized in the primary responder population. Primary responders were defined as having ≥30% decrease in mean of average daily pain intensity during the last 3 days of the pre-randomization maintenance phase relative to baseline.
418290|NCT00570310|E2|Reported Event|Placebo|Patients were treated with placebo starting at randomization.
418291|NCT00570310|E1|Reported Event|Pregabalin|Patients were treated with pregabalin (up to 600 mg/day by mouth (po)) for the entire double-blind period.
418292|NCT00570232|B1|Baseline|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418293|NCT00570232|P1|Participant Flow|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418294|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418295|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418296|NCT00570232|O1|Outcome|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418297|NCT00570232|E1|Reported Event|Tarceva|"All patients will be prescribed Tarceva 150mg daily~Erlotinib: 150 mg per day by mouth for 12 months"
418298|NCT00570141|B1|Baseline|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
418532|NCT00569777|E2|Reported Event|Placebo|etafilcon A contact lens without ketotifen
418301|NCT00570141|O1|Outcome|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
418302|NCT00570141|E1|Reported Event|OASIS Wound Matrix (Oasis)|All subjects in this study were treated with Oasis®, there were no other test articles used in this study.
418303|NCT00570089|B1|Baseline|All Study Participants|Participants who were randomized to receive either Study drug Ranexa or Placebo.
418304|NCT00570089|P2|Participant Flow|Placebo Then Study Drug Ranexa|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
418305|NCT00570089|P1|Participant Flow|Study Drug Ranexa Then Placebo|20 subjects (10 in study drug arm and 10 in placebo arm) completed period 1. In period 2, the 10 subjects who were on study drug in period 1 were on placebo arm in period 2, and the 10 subjects who were on placebo arm in period 1 were on study drug arm in period 2. The 20 subjects had a 2-week wash out in between.
418306|NCT00570089|O2|Outcome|Placebo|Placebo arm
418307|NCT00570089|O1|Outcome|Study Drug|Study drug Ranexa arm
418308|NCT00570089|O2|Outcome|Placebo - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
418309|NCT00570089|O1|Outcome|Study Drug Ranexa - CMRs (10 CMR 1 and 10 CMR 2)|CMRs (CMR 1 and CMR 2) were performed to test the efficiency of the treatment of the study drug.
418310|NCT00570089|E2|Reported Event|Placebo|Placebo arm
418311|NCT00570089|E1|Reported Event|Study Drug|Study drug Ranexa arm
418312|NCT00570037|B3|Baseline|Total|Total of all reporting groups
418313|NCT00570037|B2|Baseline|Hospital With No Immunization Program|
418314|NCT00570037|B1|Baseline|Hospital With Immunization Program|
418315|NCT00570037|P2|Participant Flow|Hospital With No Immunization Program|
418316|NCT00570037|P1|Participant Flow|Hospital With Immunization Program|
418317|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
418318|NCT00570037|O1|Outcome|Hospital With Immunization Program|
418319|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
418320|NCT00570037|O1|Outcome|Hospital With Immunization Program|
418321|NCT00570037|O2|Outcome|Hospital With No Immunization Program|
418322|NCT00570037|O1|Outcome|Hospital With Immunization Program|
418323|NCT00570037|E2|Reported Event|Hospital With No Immunization Program|
418324|NCT00570037|E1|Reported Event|Hospital With Immunization Program|
418325|NCT00569946|B1|Baseline|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418326|NCT00569946|P1|Participant Flow|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418327|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418328|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418329|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418330|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418331|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418332|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418356|NCT00569803|B2|Baseline|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
422608|NCT00558428|O2|Outcome|Amlodipine 10mg|
418333|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418334|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418335|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418336|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418337|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418338|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418339|NCT00569946|O1|Outcome|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418340|NCT00569946|E1|Reported Event|AG-013736|The starting dose of AG-013736 was 5 mg twice daily (BID), which was administered orally at approximately 12 hours apart in cycles of 4 weeks (28 days). The treatment is to be continued until the participants meet the discontinuation criteria such as disease progression or intolerable toxicity. The dose of AG-013736 could be titrated to 7 mg BID, and then 10 mg BID or reduced to 3 mg BID, and then 2 mg BID depending on the grade, type, and causality of adverse events experienced.
418341|NCT00569868|B1|Baseline|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
418342|NCT00569868|P1|Participant Flow|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
418343|NCT00569868|O1|Outcome|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
418344|NCT00569868|E1|Reported Event|Velcade|Velcade IV, 1.3 mg/m2, days 1,4,8, and 11: Treatment on this study will last 2 cycles. Each cycle consists of 3 weeks, or 21 days, then followed every three months for approximately 2 years.
418345|NCT00569855|B1|Baseline|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
418346|NCT00569855|P1|Participant Flow|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
418347|NCT00569855|O1|Outcome|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
418348|NCT00569855|E1|Reported Event|Subjects Who Received Study Drug|Subjects less than 20 kgs who received phenoxybenzamine in preparation for cardiopulmonary bypass during open-heart surgery with a dose range between 0.125mg/kg to 0.5mg/kg
418349|NCT00569803|B9|Baseline|Total|Total of all reporting groups
418350|NCT00569803|B8|Baseline|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418351|NCT00569803|B7|Baseline|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418352|NCT00569803|B6|Baseline|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418353|NCT00569803|B5|Baseline|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418354|NCT00569803|B4|Baseline|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418355|NCT00569803|B3|Baseline|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
422609|NCT00558428|O1|Outcome|Amlodipine 5mg|
418357|NCT00569803|B1|Baseline|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418358|NCT00569803|P8|Participant Flow|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418359|NCT00569803|P7|Participant Flow|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418360|NCT00569803|P6|Participant Flow|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418361|NCT00569803|P5|Participant Flow|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418362|NCT00569803|P4|Participant Flow|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418363|NCT00569803|P3|Participant Flow|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418364|NCT00569803|P2|Participant Flow|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418365|NCT00569803|P1|Participant Flow|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418366|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418367|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418368|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418369|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418370|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418371|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418372|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418373|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418374|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418375|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418376|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418377|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418378|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418379|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418380|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418381|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418382|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418383|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418384|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418385|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418386|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418387|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418388|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418389|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418390|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418391|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418392|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418393|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418394|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418395|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418396|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418397|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418398|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418399|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418400|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418401|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418402|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418403|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418404|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418405|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418406|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418407|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418408|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418409|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418410|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418411|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418412|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418413|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418414|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418415|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418416|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418417|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418418|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418419|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418420|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418421|NCT00569803|O8|Outcome|Placebo|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418422|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418423|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418424|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418425|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418426|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418427|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418428|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418429|NCT00569803|O2|Outcome|2 Injection Sites|Participants receiving treatments of 150mg, 200mg and 250mg Subcutaneous Belatacept were injected at 2 sites; one injection equal to half the total dose was delivered to the anterior thigh on each side.
418430|NCT00569803|O1|Outcome|1 Injection Site|Participants receiving treatments of 50mg, 100mg and 125mg Subcutaneous Belatacept were injected at 1 site at the anterior thigh.
418520|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418521|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418431|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418432|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418433|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418434|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418435|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418436|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418437|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418438|NCT00569803|O1|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418439|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418440|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418441|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418442|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418443|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418444|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418445|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418446|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418447|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418448|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418449|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418450|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418451|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418452|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418453|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418454|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418455|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418456|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418457|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418458|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418459|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418460|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418461|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418462|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418463|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418464|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418465|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418466|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418522|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418467|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418468|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418469|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418470|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418471|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418472|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418473|NCT00569803|O7|Outcome|Belatacept 125 mg Intravenous Infusion|125 mg Belatacept intravenous (IV) injection
418474|NCT00569803|O6|Outcome|Belatacept 250 mg Subcutaneous Injections|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418475|NCT00569803|O5|Outcome|Belatacept 200 mg Subcutaneous Injections|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418476|NCT00569803|O4|Outcome|Belatacept 150 mg Subcutaneous Injections|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418477|NCT00569803|O3|Outcome|Belatacept 125 mg Subcutaneous Injection|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418478|NCT00569803|O2|Outcome|Belatacept 100 mg Subcutaneous Injection|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418479|NCT00569803|O1|Outcome|Belatacept 50 mg Subcutaneous Injection|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418480|NCT00569803|E9|Reported Event|All Belatacept|All participants treated with IV or SC Belatacept of any dose
418481|NCT00569803|E8|Reported Event|PLACEBO|Subcutaneous injection of placebo solution (product ID: 224818-N000- 029)
418482|NCT00569803|E7|Reported Event|Belatacept 125mg IV|125 mg Belatacept intravenous (IV) injection
418483|NCT00569803|E6|Reported Event|Belatacept 250mg SC|Participants received 2 SC injections of 125 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418484|NCT00569803|E5|Reported Event|Belatacept 200mg SC|Participants received 2 SC injections of 100 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418485|NCT00569803|E4|Reported Event|Belatacept 150mg SC|Participants received 2 SC injections of 75 mg Belatacept each, in the anterior thighs. One injection was given in each thigh, with the second injection immediately following the first injection.
418486|NCT00569803|E3|Reported Event|Belatacept 125mg SC|Belatacept 125 mg SC injection into anterior thigh, 1.0 mL injection volume
418487|NCT00569803|E2|Reported Event|Belatacept 100mg SC|Belatacept 100 mg SC injection into anterior thigh, 0.8 mL injection volume
418488|NCT00569803|E1|Reported Event|Belatacept 50mg SC|Belatacept 50 mg subcutaneous (SC) injection into anterior thigh, 0.4 mL injection volume
418489|NCT00569777|B3|Baseline|Total|Total of all reporting groups
418490|NCT00569777|B2|Baseline|Placebo|etafilcon A contact lens without ketotifen
418491|NCT00569777|B1|Baseline|K-lens|etafilcon A contact lens with ketotifen.
418492|NCT00569777|P2|Participant Flow|Placebo|etafilcon A contact lens without ketotifen
418493|NCT00569777|P1|Participant Flow|K-lens|etafilcon A contact lens with ketotifen.
418494|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418495|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418496|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418497|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418498|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418499|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418500|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418501|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418502|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418503|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418504|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418505|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418506|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418507|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418508|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418509|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418510|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418511|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418512|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418513|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418514|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418515|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418516|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418517|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418518|NCT00569777|O2|Outcome|Placebo|etafilcon A contact lens without ketotifen
418519|NCT00569777|O1|Outcome|K-lens|etafilcon A contact lens with ketotifen.
418533|NCT00569777|E1|Reported Event|K-lens|etafilcon A contact lens with ketotifen.
418534|NCT00569673|B1|Baseline|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
418535|NCT00569673|P1|Participant Flow|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
418536|NCT00569673|O1|Outcome|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
418537|NCT00569673|E1|Reported Event|Docetaxel Plus Trabectedin|Docetaxel 60 mg/m2 IV over 1 hour followed by trabectedin (YONDELIS„µ, R279741) formerly referred to as, ET-743) 1.1 mg/m2 over 3 hours with Filgrastim (G-CSF, NSC #614629), Pegfilgrastim (G-CSF, NSC #725961) or Sargramostim (GM-CSF, NSC #613795) every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy.
418538|NCT00569660|B1|Baseline|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
418539|NCT00569660|P1|Participant Flow|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
418540|NCT00569660|O1|Outcome|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
418541|NCT00569660|E1|Reported Event|Azacitidine|75 mg/m^2 Subcutaneous daily for 7 days every 4 weeks
418542|NCT00569582|B1|Baseline|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
418543|NCT00569582|P1|Participant Flow|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
418544|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
418545|NCT00569582|O1|Outcome|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
418546|NCT00569582|E1|Reported Event|Mifepristone|Mifepristone was administered at doses of 300-1200 mg daily.
418547|NCT00569530|B3|Baseline|Total|Total of all reporting groups
418548|NCT00569530|B2|Baseline|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
418549|NCT00569530|B1|Baseline|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
418550|NCT00569530|P2|Participant Flow|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
418551|NCT00569530|P1|Participant Flow|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
418552|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
418553|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
418554|NCT00569530|O2|Outcome|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
418555|NCT00569530|O1|Outcome|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
418556|NCT00569530|E2|Reported Event|Sham (no Treatment)|"Infants receiving inhaled nitric oxide will receive Sham (no treatment) on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Sham Infants will not receive additional doses of Infasurf."
418557|NCT00569530|E1|Reported Event|Treatment Surfactant (Infasurf) ONY, NY|"Patients receive inhaled nitric oxide and scheduled doses of Infasurf on study days 0, 3, 7, 10, and 14, if infant remains ventilated.~Infasurf (ONY Inc.): Infasurf 3ml/kg will be given to infants on study days 0, 3, 7, 10, and 14."
418558|NCT00569374|B1|Baseline|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418559|NCT00569374|P1|Participant Flow|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418560|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418561|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418562|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418563|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418564|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418565|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418566|NCT00569374|O1|Outcome|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418567|NCT00569374|E1|Reported Event|Modafinil|All participants were started on Modafinil titrated to 400mg in this open label trial.
418568|NCT00569270|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and Tiotropium first.
418612|NCT00569192|B3|Baseline|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418569|NCT00569270|P2|Participant Flow|Placebo First, Then Tiotropium Bromide 18 µg|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
418570|NCT00569270|P1|Participant Flow|Tiotropium 18 µg Capsule First, Then Placebo|tiotropium 18 µg capsule for 1 month versus placebo. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium versus placebo
418571|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FRC/TLC|Extent of lung CT scored emphysema (percent of lung) and lung function of FRC/TLC (functional residual capacity(L)/total lung capacity (L) after tiotropium
418572|NCT00569270|O2|Outcome|TLC (L) 2h Post Tiotropium|Total Lung Capacity (L)following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h tiotropium
418573|NCT00569270|O1|Outcome|2h Post Placebo TLC(L)|total lung capacity (L) following metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
418574|NCT00569270|O2|Outcome|After DH (Dynamic Hyperinflation|IC (inspiratory capacity) before and after metronome paced hyperventilation induced dynamic hyperinflation post 30 days plus 2h placebo
418575|NCT00569270|O1|Outcome|Before DH (Dynamic Hyperinflation)|IC (inspiratory capacity) before and after metronome paced hyperventilation and induced dynamic hyperinflation at baseline;
418576|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418577|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418578|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first
418579|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418580|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418581|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418582|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418583|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418584|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418585|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418586|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418587|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418588|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418589|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418590|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418591|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418592|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418593|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418594|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and IC|Extent of lung CT scored emphysema (percent of lung) and lung function of IC (inspiratory capacity, L) after tiotropium.
418595|NCT00569270|O2|Outcome|Tiotropium 18 µg Capsule, Bronchodilator|Includes groups randomized to receive placebo first and Tiotropium first.
418596|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418597|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418598|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418599|NCT00569270|O1|Outcome|Lung CT Scored Emphysema and FEV1|Extent of lung CT scored emphysema and and lung function of FEV1(l) after tiotropium
418600|NCT00569270|O2|Outcome|Tiotropium|Includes groups randomized to receive placebo first and Tiotropium first.
418601|NCT00569270|O1|Outcome|Placebo|Includes groups randomized to receive placebo first and Tiotropium first.
418602|NCT00569270|E2|Reported Event|Placebo|Adverse events after placebo. (30 enrolled subjects, one drop-out)
418603|NCT00569270|E1|Reported Event|Tiotropium Bromide 18 µg, Capsule,|tiotropium 18 µg capsule for 1 month. To study bronchodilation and effect following metronome paced hyperventilation and induced dynamic hyperinflation of active tiotropium. (30 enrolled subjects, one drop-out)
418604|NCT00569231|B1|Baseline|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418605|NCT00569231|P1|Participant Flow|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418606|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418607|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418608|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418609|NCT00569231|O1|Outcome|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418610|NCT00569231|E1|Reported Event|Candida Antigen|All patients enrolled into the study were treated with intralesional injection of 0.3ml candida antigen into largest wart at baseline visit and then every 3 weeks +/- 3 days for a maximum of 10 treatments.
418611|NCT00569192|B4|Baseline|Total|Total of all reporting groups
418613|NCT00569192|B2|Baseline|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418614|NCT00569192|B1|Baseline|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418615|NCT00569192|P3|Participant Flow|0.25 mg MAP0010|0.125mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418616|NCT00569192|P2|Participant Flow|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418617|NCT00569192|P1|Participant Flow|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418618|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418619|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418620|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418621|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418622|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418623|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418624|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418625|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418626|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418627|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418628|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418629|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418630|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418631|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418632|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418633|NCT00569192|O3|Outcome|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418634|NCT00569192|O2|Outcome|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418635|NCT00569192|O1|Outcome|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418636|NCT00569192|E3|Reported Event|0.25 mg MAP0010|0.25mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418637|NCT00569192|E2|Reported Event|0.135 mg MAP0010|0.135mg MAP0010 (unit dose budesonide) delivered by nebulization twice daily for 12 weeks
418638|NCT00569192|E1|Reported Event|Placebo|Placebo delivered by nebulization twice daily for 12 weeks
418639|NCT00569166|B4|Baseline|Total|Total of all reporting groups
418640|NCT00569166|B3|Baseline|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418641|NCT00569166|B2|Baseline|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418642|NCT00569166|B1|Baseline|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418643|NCT00569166|P3|Participant Flow|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418644|NCT00569166|P2|Participant Flow|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418645|NCT00569166|P1|Participant Flow|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418646|NCT00569166|O3|Outcome|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418647|NCT00569166|O2|Outcome|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418648|NCT00569166|O1|Outcome|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418649|NCT00569166|E3|Reported Event|Paced Breathing (10 Min Once Daily, 14 Breaths/Min)|Patients practice paced breathing for 10 minutes once daily, 14 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418650|NCT00569166|E2|Reported Event|Paced Breathing (15 Min Twice Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes twice daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418651|NCT00569166|E1|Reported Event|Paced Breathing (15 Min Once Daily, 6 Breaths/Min)|Patients practice paced breathing for 15 minutes once daily, 6 breaths/min, 5-7 days weekly, following an instructional compact disc (CD), for 8 weeks.
418652|NCT00569127|B3|Baseline|Total|Total of all reporting groups
418653|NCT00569127|B2|Baseline|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418654|NCT00569127|B1|Baseline|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
422610|NCT00558428|E4|Reported Event|Telmisartan 80mg and Amlodipine 5mg|
418655|NCT00569127|P2|Participant Flow|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418656|NCT00569127|P1|Participant Flow|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418657|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418658|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418659|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418660|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418661|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418662|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418663|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418664|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418665|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418666|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418667|NCT00569127|O2|Outcome|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418668|NCT00569127|O1|Outcome|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418669|NCT00569127|E2|Reported Event|Octreotide, Interferon Alpha-2b|Patients receive 20 mg depot octreotide acetate IM on day 1 and 5 million units interferon alpha-2b three times per week (Days 1, 3, 5, 8, 10, 12, 15, 17, 19 of each cycle). Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418670|NCT00569127|E1|Reported Event|Octreotide, Bevacizumab|Patients receive 20 mg depot octreotide acetate IM and 15 mg/kg bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
418671|NCT00569010|B5|Baseline|Total|Total of all reporting groups
418672|NCT00569010|B4|Baseline|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418673|NCT00569010|B3|Baseline|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
418674|NCT00569010|B2|Baseline|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418675|NCT00569010|B1|Baseline|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
418676|NCT00569010|P4|Participant Flow|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418677|NCT00569010|P3|Participant Flow|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
418678|NCT00569010|P2|Participant Flow|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418679|NCT00569010|P1|Participant Flow|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
418680|NCT00569010|O4|Outcome|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418681|NCT00569010|O3|Outcome|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
418682|NCT00569010|O2|Outcome|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
422611|NCT00558428|E3|Reported Event|Telmisartan 40mg and Amlodipine 5mg|
418683|NCT00569010|O1|Outcome|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
418684|NCT00569010|E4|Reported Event|High-Dose Ara-C + AZA-Level 1|High-dose Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65 years); AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418685|NCT00569010|E3|Reported Event|High-Dose Ara-C + AZA-Level 0|Ara-C: 1 g/m^2 Daily CIV for 4 days (age<65years) or 3 days (age>=65years); AZA: 37.5 mg/m^2 IV Over 20-30 minutes Daily for 7 Days
418686|NCT00569010|E2|Reported Event|Low-Dose Ara-C + AZA-Level 1|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days AZA: Level 1 = 75.0 mg/m^2 IV Over 20-30 minutes Daily for 7 days
418687|NCT00569010|E1|Reported Event|Low-Dose Ara-C + AZA-Level 0|Low-Dose Ara-C: 100 mg/m^2 Daily continuous intravenous infusion (CIV) for 7 days; Azacitidine (AZA): 37.5 mg/m^2 intravenous (IV) Over 20-30 minutes Daily for 7 Days
418688|NCT00568958|B3|Baseline|Total|Total of all reporting groups
418689|NCT00568958|B2|Baseline|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418690|NCT00568958|B1|Baseline|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418691|NCT00568958|P2|Participant Flow|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418692|NCT00568958|P1|Participant Flow|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418693|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418694|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418695|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418696|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418697|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418698|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418794|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418895|NCT00568061|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
418699|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418700|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418701|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418702|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418703|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418704|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418705|NCT00568958|O2|Outcome|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418706|NCT00568958|O1|Outcome|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418707|NCT00568958|E2|Reported Event|Placebo Naltrexone|"Placebo Naltrexone (targeted + daily) + BASICS Counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~placebo naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) placebo for a period of 8 weeks."
418708|NCT00568958|E1|Reported Event|Naltrexone|"Active naltrexone (25 mg daily +25 targeted)+ BASICS counseling~BASICS counseling: Brief Alcohol Screening and Intervention for College Students (BASICS) is a form of counseling that was developed originally for use with undergraduates. It combines three main elements: motivational enhancement strategies, skills for moderating consumption, and provision of individualized feedback.~naltrexone: Daily + targeted (i.e., taken as needed in anticipation of a high-risk situation) naltrexone, 25mg each for a total possible dose of 50mg (the FDA-approved dose for alcohol dependence) in a given day for a period of 8 weeks."
418709|NCT00568854|B3|Baseline|Total|Total of all reporting groups
418710|NCT00568854|B2|Baseline|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418711|NCT00568854|B1|Baseline|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418712|NCT00568854|P2|Participant Flow|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418713|NCT00568854|P1|Participant Flow|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418714|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418715|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418716|NCT00568854|O2|Outcome|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418717|NCT00568854|O1|Outcome|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418718|NCT00568854|E2|Reported Event|Participants Without Diabetes|"Persons with no diagnosis of diabetes and negative diabetes screening labs. Received biological intervention: BCG.~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418719|NCT00568854|E1|Reported Event|Participants With Diabetes|"Persons with diagnosis of diabetes. Received biological intervention: BCG~BCG: Both arms: diabetics and nondiabetics will receive vaccination in the upper arm with a 0.1-mg intradermal dose of a single strain of BCG (Mycobax, Sanofi-Aventis), which is FDA approved for this indication."
418720|NCT00568776|B5|Baseline|Total|Total of all reporting groups
418721|NCT00568776|B4|Baseline|ELND005 2000 mg BID|oral administration for 78 weeks
418722|NCT00568776|B3|Baseline|ELND005 1000 mg BID|oral administration for 78 weeks
418723|NCT00568776|B2|Baseline|ELND005 250 mg BID|oral administration for 78 weeks
418724|NCT00568776|B1|Baseline|Placebo BID|oral administration for 78 weeks
418725|NCT00568776|P4|Participant Flow|ELND005 2000 mg BID|oral administration for 78 weeks
418726|NCT00568776|P3|Participant Flow|ELND005 1000 mg BID|oral administration for 78 weeks
418727|NCT00568776|P2|Participant Flow|ELND005 250 mg BID|oral administration for 78 weeks
418728|NCT00568776|P1|Participant Flow|Placebo BID|oral administration for 78 weeks
418729|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418730|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418731|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418732|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418733|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418734|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418735|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418736|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418737|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418738|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418739|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418740|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418741|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418742|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418743|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418744|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418745|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418746|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418747|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418748|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418749|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418750|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418751|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418752|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418753|NCT00568776|O4|Outcome|ELND005 2000 mg BID|oral administration for 78 weeks
418754|NCT00568776|O3|Outcome|ELND005 1000 mg BID|oral administration for 78 weeks
418755|NCT00568776|O2|Outcome|ELND005 250 mg BID|oral administration for 78 weeks
418756|NCT00568776|O1|Outcome|Placebo BID|oral administration for 78 weeks
418757|NCT00568776|E4|Reported Event|ELND005 2000 mg BID|oral administration for 78 weeks
418758|NCT00568776|E3|Reported Event|ELND005 1000 mg BID|oral administration for 78 weeks
418759|NCT00568776|E2|Reported Event|ELND005 250 mg BID|oral administration for 78 weeks
418760|NCT00568776|E1|Reported Event|Placebo BID|oral administration for 78 weeks
418761|NCT00568685|B4|Baseline|Total|Total of all reporting groups
418762|NCT00568685|B3|Baseline|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418763|NCT00568685|B2|Baseline|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418764|NCT00568685|B1|Baseline|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418795|NCT00568685|E3|Reported Event|Atomoxetine >0.85 mg/kg/Day|Patients who received the actual dose range listed.
418896|NCT00568022|B4|Baseline|Total|Total of all reporting groups
418765|NCT00568685|P3|Participant Flow|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418766|NCT00568685|P2|Participant Flow|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418767|NCT00568685|P1|Participant Flow|Atomoxetine 0.2 Milligrams Per Kilogram, Per Day (mg/kg/Day)|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418768|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418769|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418770|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418771|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418772|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418773|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418774|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418775|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418776|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418777|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418778|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418779|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418780|NCT00568685|O3|Outcome|>0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
418781|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
418782|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
418783|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418784|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418785|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418786|NCT00568685|O3|Outcome|> 0.85 mg/kg/Day|Patients received atomoxetine >0.85 mg/kg/day
418787|NCT00568685|O2|Outcome|0.36-0.85 mg/kg/Day|Patients received atomoxetine 0.36-0.85 mg/kg/day
418788|NCT00568685|O1|Outcome|0-0.35 mg/kg/Day|Patients received atomoxetine 0-0.35 mg/kg/day
418789|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418790|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418791|NCT00568685|O1|Outcome|Atomoxetine 0.2 mg/kg/Day|Patients receive 0.2 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418792|NCT00568685|O3|Outcome|Atomoxetine 1.2 mg/kg/Day|Patients initially receive atomoxetine 0.5 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will then receive atomoxetine 0.8 mg/kg/day administered orally in two divided doses for approximately 7 days. Patients will receive atomoxetine 1.2 mg/kg/day administered orally in two divided doses for the remainder of the study, lasting approximately 28 days.
418793|NCT00568685|O2|Outcome|Atomoxetine 0.5 mg/kg/Day|Patients receive 0.5 mg/kg/day atomoxetine administered orally in two divided doses for the duration of the 6-week acute treatment period.
418796|NCT00568685|E2|Reported Event|Atomoxetine 0.36-0.85 mg/kg/Day|Patients who received the actual dose range listed.
418797|NCT00568685|E1|Reported Event|Atomoxetine 0.00-0.35 mg/kg/Day|Patients who received the actual dose range listed.
418798|NCT00568555|B3|Baseline|Total|Total of all reporting groups
418799|NCT00568555|B2|Baseline|Placebo - Sugar Pill|
418800|NCT00568555|B1|Baseline|Low Dose Naltrexone|
418801|NCT00568555|P2|Participant Flow|Placebo - Sugar Pill First|Placebo first, followed by LDN. Placebo (sugar pill) once a day. LDN at 3-4.5mg, once a day.
418802|NCT00568555|P1|Participant Flow|Low Dose Naltrexone First|Low Dose Naltrexone (LDN) followed by placebo. LDN at 3-4.5mg, once a day. Placebo (sugar pill) once a day.
418803|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
418804|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
418805|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
418806|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
418807|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
418808|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
418809|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participant during the placebo condition
418810|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the low dose naltrexone condition
418811|NCT00568555|O2|Outcome|Placebo - Sugar Pill|All participants during the placebo condition
418812|NCT00568555|O1|Outcome|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
418813|NCT00568555|E2|Reported Event|Placebo - Sugar Pill|All participants during the placebo condition
418814|NCT00568555|E1|Reported Event|Low Dose Naltrexone|All participants during the Low Dose Naltrexone condition
418815|NCT00568451|B5|Baseline|Total|Total of all reporting groups
418816|NCT00568451|B4|Baseline|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
418817|NCT00568451|B3|Baseline|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
418818|NCT00568451|B2|Baseline|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
418819|NCT00568451|B1|Baseline|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
418820|NCT00568451|P4|Participant Flow|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
418821|NCT00568451|P3|Participant Flow|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
418822|NCT00568451|P2|Participant Flow|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
418823|NCT00568451|P1|Participant Flow|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
418824|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418825|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418826|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418827|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418828|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418829|NCT00568451|O1|Outcome|Overall|TMZ (Previously Treated) and TMZ (Chemo Naive)
418830|NCT00568451|O4|Outcome|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
418831|NCT00568451|O3|Outcome|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
418832|NCT00568451|O2|Outcome|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
418833|NCT00568451|O1|Outcome|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
418834|NCT00568451|E4|Reported Event|PC (Chemo Naive)|Chemotherapy-naive cohorts: Paclitaxel and Carboplatin (PC)
418835|NCT00568451|E3|Reported Event|PC (Previously Treated)|Previously chemotherapy treated cohorts: Paclitaxel and Carboplatin (PC)
418836|NCT00568451|E2|Reported Event|TMZ (Chemo Naive)|Chemotherapy-naive cohorts: Temozolomide (TMZ)
418837|NCT00568451|E1|Reported Event|TMZ (Previously Treated)|Previously chemotherapy treated cohorts: Temozolomide (TMZ)
418838|NCT00568399|B1|Baseline|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
418839|NCT00568399|P1|Participant Flow|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
418840|NCT00568399|O1|Outcome|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months
418841|NCT00568399|E1|Reported Event|Sodium Thiosulfate|Treatment with sodium thiosulfate after each dialysis for 5 months and the battery of cardiovascular tests were repeated in those who completed the 5 months of treatment.subjects with high coronary artery calcium scores.
418842|NCT00568386|B3|Baseline|Total|Total of all reporting groups
418843|NCT00568386|B2|Baseline|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
418844|NCT00568386|B1|Baseline|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
418845|NCT00568386|P2|Participant Flow|Optive Drops Then Systane Drops|Optive Drops then Systane Drops
418846|NCT00568386|P1|Participant Flow|Systane Drops Then Optive Drops|Systane Drops then Optive Drops
418847|NCT00568386|O2|Outcome|Optive Lubricant Eye Drops|Optive Lubricant eye drops
418848|NCT00568386|O1|Outcome|Systane Lubricant Eye Drops|Systane lubricant eye drops
418849|NCT00568386|E2|Reported Event|Optive Lubricant Eye Drops|Optive Lubricant eye drops
418850|NCT00568386|E1|Reported Event|Systane Lubricant Eye Drops|Systane lubricant eye drops
418851|NCT00568178|B3|Baseline|Total|Total of all reporting groups
418890|NCT00568061|P2|Participant Flow|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
418891|NCT00568061|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
418852|NCT00568178|B2|Baseline|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
418853|NCT00568178|B1|Baseline|Losartan|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
418854|NCT00568178|P6|Participant Flow|Enalapril Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Enalapril 2.5-, 5-, 10-, and 20-mg tablets were available for participants able to swallow tablets. For participants unable to swallow tablets, or who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared."
418855|NCT00568178|P5|Participant Flow|Losartan Open Label Extension|"Participants were stratified based on assigned treatment in the double-blind treatment phase and were randomized in a 1:1 ratio to either losartan or enalapril.~Dosing of study medication during the extension phase of the study was at the investigator’s discretion.~Losartan 25-mg and 50-mg tablets were available for patients able to swallow tablets. For patients unable to swallow tablets, or who weighed <25 kg, losartan suspension (2.5 mg/ml) was prepared."
418856|NCT00568178|P4|Participant Flow|Amlodipine Double Blind Hypertensive|"Hypertensive patients who were randomized to receive amlodipine and losartan placebo for 12 weeks.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
418857|NCT00568178|P3|Participant Flow|Losartan Double Blind Hypertensive|"Hypertensive patients who were randomized to receive losartan and amlodipine placebo for 12 weeks.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
418858|NCT00568178|P2|Participant Flow|Placebo Double Blind Normotensive|"Normotensive participants who were randomized to losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
418859|NCT00568178|P1|Participant Flow|Losartan Double Blind Normortensive|"Normotensive participants who were randomized to losartan.~Losartan dispensed as tablets or suspension depending on participant weight and ability to swallow tablets.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Losartan tablet dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks; or losartan placebo."
418860|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
418861|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension and were randomly assigned using a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All patients who entered the extension continued until the 100th patient completed approximately 3 years of follow-up.
418862|NCT00568178|O2|Outcome|Enalapril Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
418892|NCT00568061|O2|Outcome|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
418893|NCT00568061|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
418894|NCT00568061|E2|Reported Event|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
418863|NCT00568178|O1|Outcome|Losartan Open Label Extension|All participants who completed the 12-week double-blind treatment phase (or discontinued early due to increased proteinuria) were invited to participate in the open-label extension. Participants were randomized in a 1:1 ratio to either losartan or enalapril therapy. The duration of the extension varied, depending on the time of enrollment. All participants who entered the extension could continue until the 100th participant completed approximately 3 years of follow-up.
418864|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
418865|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
418866|NCT00568178|O2|Outcome|Amlodipine-Hypertensive Participants|Group includes hypertensive participants who were randomized to amlodipine and losartan placebo.
418867|NCT00568178|O1|Outcome|Losartan-Hypertensive Participants|Group includes hypertensive participants who were randomized to losartan and amlodipine placebo.
418868|NCT00568178|O2|Outcome|Amlodipine/Placebo|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
418869|NCT00568178|O1|Outcome|Losartan|Participants were randomized in a 1:1 ratio within each stratum: hypertensive patients (6 to 17 years of age) were randomized to either amlodipine or losartan; normotensive patients (1 to 17 years of age) were randomized to either placebo or losartan. Losartan (or placebo) therapy was administered orally, in tablet or suspension form, at an initial dose of approximately 0.7 mg/kg once daily (up to 50 or 100 mg total daily dose, weight-dependent). Participants who were randomized to losartan were assigned to a normotensive or hypertensive group, based on clinical profile.
418870|NCT00568178|E4|Reported Event|Enalapril: Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum specified dose of enalapril was 40 mg/day. For participants unable to swallow tablets, or for those who weighed <25 kg, enalapril suspension (1 mg/mL) was prepared. The starting dose of drug and any adjustments during the open-label period were at the discretion of the investigator."
418871|NCT00568178|E3|Reported Event|Losartan Open-Label Extension|"Please note that the open label participant population was derived exclusively from the original base study population. There was no additional recruitment.~Participants were randomized to either losartan or enalapril, administered in an unblinded fashion (placebo was not used) for the duration of the study. The maximum dose of losartan was 50 mg/day (if the participant weighed <50 kg) or 100 mg/day (if the participant weighed ≥50 kg) Losartan 25-mg and 50-mg tablets were available for participants able to swallow tablets, and losartan suspension (2.5 mg/ml) was prepared for participants unable to swallow tablets, or for those who weighed <25 kg."
418872|NCT00568178|E2|Reported Event|Amlodipine/Placebo: Double-Blind Base Study|"Amlodipine/Placebo group includes the following: Normotensive patients randomized to losartan placebo. Hypertensive patients randomized to amlodipine and losartan placebo.~Losartan placebo dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine dispensed as suspension for duration of study. Losartan placebo suspension dosing: 0.7 mg/kg/day titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks.~Amlodipine suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan placebo tablet dosing: 25 mg/day orally titrated to 50 mg/day (patients <50 kg) OR 50 mg/day orally titrated to 100 mg/day (patients ≥50 kg) for 12 weeks."
418873|NCT00568178|E1|Reported Event|Losartan: Double-Blind Base Study|"Four arms combined to 2 groups (losartan & amlodipine/placebo) for reporting and compared those who took losartan to those who did not (i.e., participants took amlodipine and/or placebo).~Losartan group: Normotensives were randomized to losartan and Hypertensives were randomized to losartan & amlodipine placebo.~Losartan dispensed as tablets or suspension depending on patient weight and ability to swallow tablets. Amlodipine placebo dispensed as suspension for duration of study.~Losartan suspension dosing: 0.7 milligram/kilograms/day (mg/kg/day) titrated at 2 weeks to 1.4 mg/kg/day orally (maximum 50 mg if <50 kg or 100 mg if ≥50 kg) for 12 weeks. Amlodipine placebo suspension dosing: starting dose 0.05 or 0.1 titrated to 0.2 mg/kg/day orally (max 5 mg/day) after 2 weeks if necessary to control blood pressure for 12 weeks. Losartan dosing: 25 mg/day orally titrated to 50 mg/day (participants <50 kg) OR 50 mg/day orally titrated to 100 mg/day (participants ≥50 kg) for 12 weeks."
418874|NCT00568087|B3|Baseline|Total|Total of all reporting groups
418875|NCT00568087|B2|Baseline|Placebo|Identical placebo daily for 8 weeks
418876|NCT00568087|B1|Baseline|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418877|NCT00568087|P2|Participant Flow|Placebo|Identical placebo daily for 8 weeks
418878|NCT00568087|P1|Participant Flow|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418879|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
418880|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418881|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
418882|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418883|NCT00568087|O2|Outcome|Placebo|Identical placebo daily for 8 weeks
418884|NCT00568087|O1|Outcome|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418885|NCT00568087|E2|Reported Event|Placebo|Identical placebo daily for 8 weeks
418886|NCT00568087|E1|Reported Event|N-acetylcysteine|N-acetylcysteine daily for 8 weeks
418887|NCT00568061|B3|Baseline|Total|Total of all reporting groups
418888|NCT00568061|B2|Baseline|Nitrogen Gas|Nitrogen Gas (Placebo) administered at 80ppm
418889|NCT00568061|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide administered at 80ppm
418897|NCT00568022|B3|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418898|NCT00568022|B2|Baseline|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418899|NCT00568022|B1|Baseline|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418900|NCT00568022|P3|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|After receiving Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418901|NCT00568022|P2|Participant Flow|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|After receiving Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day, the dose was escalated such that participants received Ixabepilone 40 mg/m^2 administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418902|NCT00568022|P1|Participant Flow|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418903|NCT00568022|O1|Outcome|All Participants With Measurable Disease and Tumor Response|The evaluable participant population consisted of participants who met the minimum safety evaluation requirements of the study: participant received ≥ 1 dose of ixabepilone and/or capecitabine in Cycle 1, completed adequate safety evaluations, and was observed for ≥ 21 days following the first dose or the participant experienced DLT.
418904|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418905|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418906|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418907|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418908|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418909|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418910|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418911|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418912|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418913|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418914|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418915|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418916|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418917|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418918|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418919|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
422612|NCT00558428|E2|Reported Event|Amlodipine 10mg|
418920|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418921|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418922|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418923|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418924|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418925|NCT00568022|O3|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418926|NCT00568022|O2|Outcome|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418927|NCT00568022|O1|Outcome|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418928|NCT00568022|E3|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 2000 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 2000 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418929|NCT00568022|E2|Reported Event|Ixabepilone 40 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 40 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each 21-day treatment cycle.
418930|NCT00568022|E1|Reported Event|Ixabepilone 32 mg/m^2 + Capecitabine 1650 mg/m^2/Day|Ixabepilone 32 mg/m^2 was administered via intravenous (IV) infusion over 3 hours on Day 1 of each 21-day treatment cycle. Capecitabine 1650 mg/m^2/day was administered on Days 1 to 14 of each treatment cycle.
418931|NCT00567996|B4|Baseline|Total|Total of all reporting groups
418932|NCT00567996|B3|Baseline|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418933|NCT00567996|B2|Baseline|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418934|NCT00567996|B1|Baseline|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418935|NCT00567996|P3|Participant Flow|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418936|NCT00567996|P2|Participant Flow|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418937|NCT00567996|P1|Participant Flow|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418938|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418939|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
419000|NCT00567593|P1|Participant Flow|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
419001|NCT00567593|O1|Outcome|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
419002|NCT00567593|E1|Reported Event|Rosiglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
418940|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418941|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418942|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418943|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418944|NCT00567996|O3|Outcome|Placebo|Placebo to indacaterol inhaled via SDDPI. Placebo to salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418945|NCT00567996|O2|Outcome|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418946|NCT00567996|O1|Outcome|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418947|NCT00567996|E3|Reported Event|Placebo|Placebo to Indacaterol once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418948|NCT00567996|E2|Reported Event|Salmeterol 50 μg|Salmeterol 50 μg twice daily delivered via a proprietary dry powder inhaler in the morning and in the evening. Placebo to Indacaterol daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418949|NCT00567996|E1|Reported Event|Indacaterol 150 μg|Indacaterol 150 μg once daily in the morning, inhaled via a single dose dry powder inhaler (SDDPI). Placebo to Salmeterol delivered twice daily via a proprietary dry powder inhaler in the morning and in the evening. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol/albuterol was available for rescue use throughout the study.
418950|NCT00567892|B3|Baseline|Total|Total of all reporting groups
418951|NCT00567892|B2|Baseline|4 Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
418952|NCT00567892|B1|Baseline|2 Week Treatment|Treatment (either active rTMS or sham)for 2 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 2 weeks
418953|NCT00567892|P4|Participant Flow|Sham Then Active rTMS Treatment (4 Weeks)|Sham treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks Active rTMS Treatment. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
418954|NCT00567892|P3|Participant Flow|Active Then Sham rTMS Treatment (4 Weeks)|Active rTMS Treatment for 4 weeks followed by 2 weeks wash-out and then 4 weeks sham.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.One subject had a drop of THI larger than 20 points from baseline after first arm of treatment and did not get the second arm.
418955|NCT00567892|P2|Participant Flow|Sham Then Active rTMS Treatment (2 Weeks)|Sham treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks Active rTMS Treatment.Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
419003|NCT00567541|B3|Baseline|Total|Total of all reporting groups
419023|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419766|NCT00565747|E2|Reported Event|Control Culture|Culture without GM-CSF
418956|NCT00567892|P1|Participant Flow|Active Then Sham rTMS Treatment (2 Weeks)|Active rTMS Treatment for 2 weeks followed by 2 weeks wash-out and then 2 weeks sham. Subjects who do not return to within 20 points of Baseline THI at the end of 2 weeks washout will have washout extended up to 2 additional 2-week washout-periods.At the end of 6 weeks total washout, if the subject's THI remains greater than 20 points difference from bsseline THI subject will be considered to have completed the study and will not complete the second cross study arm. Subject will go staight to end of study visit.
418957|NCT00567892|O4|Outcome|4-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
418958|NCT00567892|O3|Outcome|4-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
418959|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks).
418960|NCT00567892|O1|Outcome|2-Weeks Active rTMSTreatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold)
418961|NCT00567892|O4|Outcome|4-weeks rTMS Sham Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 4 weeks.
418962|NCT00567892|O3|Outcome|4-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 4 weeks.
418963|NCT00567892|O2|Outcome|2-Weeks Sham rTMS Treatment|Daily sham-rTMS for about 1 hour with sham device settings for 2 weeks.
418964|NCT00567892|O1|Outcome|2-weeks rTMS Active Treatment|Daily rTMS for about 1 hour with active device settings (stimulation intensity at 110% of motor threshold), for 2 weeks.
418965|NCT00567892|E2|Reported Event|Four Week Treatment|Treatment (either active rTMS or sham)for 4 weeks followed by 2 week wash-out then treatment (opposite of first assignment)for 4 weeks
418966|NCT00567892|E1|Reported Event|2 Weeks Treatment|Treatment (either active rTMS or sham) for two weeks followed by 2 weeks wash-out then treatment (opposite of first assignment)for two weeks
418967|NCT00567879|B7|Baseline|Total|Total of all reporting groups
418968|NCT00567879|B6|Baseline|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418969|NCT00567879|B5|Baseline|Oral Arm - Schedule B 15mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418970|NCT00567879|B4|Baseline|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
418971|NCT00567879|B3|Baseline|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418972|NCT00567879|B2|Baseline|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418973|NCT00567879|B1|Baseline|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418974|NCT00567879|P6|Participant Flow|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418975|NCT00567879|P5|Participant Flow|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418976|NCT00567879|P4|Participant Flow|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
418977|NCT00567879|P3|Participant Flow|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418978|NCT00567879|P2|Participant Flow|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418979|NCT00567879|P1|Participant Flow|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418980|NCT00567879|O6|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418981|NCT00567879|O5|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418982|NCT00567879|O4|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
418983|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418984|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418985|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418986|NCT00567879|O7|Outcome|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418987|NCT00567879|O6|Outcome|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418988|NCT00567879|O5|Outcome|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
418989|NCT00567879|O4|Outcome|Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418990|NCT00567879|O3|Outcome|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418991|NCT00567879|O2|Outcome|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418992|NCT00567879|O1|Outcome|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418993|NCT00567879|E6|Reported Event|Oral Arm - Schedule B 20mg|20 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418994|NCT00567879|E5|Reported Event|Oral Arm - Schedule B 15 mg|15 mg was given three times weekly for two consecutive weeks as part of a 21-day treatment cycle.
418995|NCT00567879|E4|Reported Event|Oral Arm - Schedule A 20mg|20 mg was given twice weekly for two consecutive weeks as part of a 21-day treatment cycle.
418996|NCT00567879|E3|Reported Event|Escalation/Expansion: i.v. Arm -20mg/m^2|20 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418997|NCT00567879|E2|Reported Event|Escalation: i.v. Arm - 15mg/m^2|15 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418998|NCT00567879|E1|Reported Event|Escalation: i.v. Arm - 10mg/m^2|10 mg/m^2 i.v. was given on day 1 and day 8 of a 21 day cycle.
418999|NCT00567593|B1|Baseline|Rosaglitazone|Rosiglitazone: 8mg tablet once a day for 14 days
419004|NCT00567541|B2|Baseline|Sham BBPM Stimulation|Sham Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation.
419005|NCT00567541|B1|Baseline|Active BBPM Stimulation|Active Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
419006|NCT00567541|P2|Participant Flow|Sham BBPM Stimulation|"The Battery Powered Microneuromodulator(BBPM) will be programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, they will be reprogrammed to receive therapeutic stimulation.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device will be reprogrammed to deliver therapeutic stimulation."
419007|NCT00567541|P1|Participant Flow|Active BBPM Stimulation|"The Battery Powered Microneuromodulator (BBPM) is programmed to deliver set therapeutic stimulation parameters for the first 12 weeks of the study.~Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) will be programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation. therapeutic treatment."
419008|NCT00567541|O2|Outcome|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
419009|NCT00567541|O1|Outcome|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
419010|NCT00567541|E2|Reported Event|Sham BBPM Stimulation|The Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver short bursts of extremely low amplitude electrical stimulation at very wide time intervals to give appearance, impression, and sensation of therapeutic treatment. After 24 weeks, the device is reprogrammed to deliver therapeutic stimulation.
419011|NCT00567541|E1|Reported Event|Active BBPM Stimulation|The.Battery Powered Microneuromodulator (BBPM): The Battery Powered Microneuromodulator (BBPM) is programmed for the first 12 weeks of the study to deliver therapeutic amplitude electrical stimulation.
419012|NCT00567502|B5|Baseline|Total|Total of all reporting groups
419013|NCT00567502|B4|Baseline|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
419014|NCT00567502|B3|Baseline|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419015|NCT00567502|B2|Baseline|XAGRID+Other (Cytoreductives)|Participants who received XAGRID along with Other cytoreductives drugs at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419016|NCT00567502|B1|Baseline|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
419017|NCT00567502|P4|Participant Flow|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator’s discretion.
419018|NCT00567502|P3|Participant Flow|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419019|NCT00567502|P2|Participant Flow|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419020|NCT00567502|P1|Participant Flow|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion
419021|NCT00567502|O2|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years. Other Cytoreductives included Hydroxyurea, Interferonalpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419022|NCT00567502|O1|Outcome|XAGRID|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419024|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419025|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419026|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419027|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419028|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419029|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419030|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419031|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC, was observed for 5 years.
419032|NCT00567502|O9|Outcome|Other|Participants who received other therapies at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419033|NCT00567502|O8|Outcome|Other (Cytoreductives)-Thromboreductin|Participants who received other (Cytoreductives)-Thromboreductin at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419034|NCT00567502|O7|Outcome|Other (Cytoreductives)-Sodium Phosphate P32|Participants who received other (Cytoreductives)-Sodium Phosphate P32 at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419035|NCT00567502|O6|Outcome|Other (Cytoreductives)-Pipobroman|Participants who received other (Cytoreductives)-Pipobroman at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419036|NCT00567502|O5|Outcome|Other (Cytoreductives)-Busulphan|Participants who received other (Cytoreductives)-Busulphan at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419037|NCT00567502|O4|Outcome|Other (Cytoreductives)-Pegylated Interferon|Participants who received other (Cytoreductives)-Pegylated Interferon at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419038|NCT00567502|O3|Outcome|Other (Cytoreductives)-Interferon Alpha|Participants who received other (Cytoreductives)-Interferon Alpha at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419039|NCT00567502|O2|Outcome|Other (Cytoreductives)-Hydroxyurea|Participants who received other (Cytoreductives)-Hydroxyurea at a dose and mode of administration managed as per investigator’s discretion and the relevant SmPC, was observed for 5 years.
419040|NCT00567502|O1|Outcome|XAGRID Taken|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study for a 5 year observation period."
419041|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
419042|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419043|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419044|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
419045|NCT00567502|O4|Outcome|No Essential Thrombocythemia (ET) Therapy|Participants who were not receiving any cytoreductive treatment for at least 28 consecutive days at the time of registering into the study for a 5 year observation period, during which participants were able to switch treatments per investigator's discretion.
419046|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419047|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419767|NCT00565747|E1|Reported Event|Test Culture|Culture with 2 ng/ml GM-CSF
419048|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
419049|NCT00567502|O3|Outcome|Other (Cytoreductives)|Participants who received other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419050|NCT00567502|O2|Outcome|XAGRID+Other (Cytoreductives)|Participants who received XAGRID+Other (Cytoreductives) at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32.
419051|NCT00567502|O1|Outcome|XAGRID Only|Participants who received XAGRID at a dose and mode of administration managed as per investigator's discretion and the relevant SmPC at the time of registering into the study or after switching from another treatment any time during the 5 year observation period.
419052|NCT00567502|E2|Reported Event|Other (Cytoreductives)|"Participants who received other (cytoreductives) from  other (cytoreductives or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period. Other Cytoreductives included Hydroxyurea, Interferon- alpha, Pegylated interferon, Busulphan, Pipobroman, Sodium phosphate P32."
419053|NCT00567502|E1|Reported Event|XAGRID|"Participants who received XAGRID from Xagrid only or Xagrid+other (cytoreductives) arm groups (for serious adverse events) at a dose and mode of administration managed as per investigator's discretion and the relevant Summary of Product Characteristics (SmPC) at the time of registering into the study or after switching from another treatment (other adverse events) any time during the 5 year observation period."
419054|NCT00567476|B3|Baseline|Total|Total of all reporting groups
419055|NCT00567476|B2|Baseline|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419056|NCT00567476|B1|Baseline|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419057|NCT00567476|P2|Participant Flow|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419058|NCT00567476|P1|Participant Flow|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419059|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419060|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419061|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419062|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419063|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419064|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419065|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419066|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419067|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419068|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419069|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419070|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419071|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419072|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419073|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419074|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419075|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419076|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419107|NCT00567268|O2|Outcome|CLcr >=30 and <60 mL/Min|Participants with baseline creatinine clearance >=30 and <60 mL/min
419108|NCT00567268|O1|Outcome|CLcr >=60 mL/Min|Participants with baseline creatinine clearance >=60 mL/min
420208|NCT00564447|P2|Participant Flow|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
419077|NCT00567476|O2|Outcome|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419078|NCT00567476|O1|Outcome|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419079|NCT00567476|E2|Reported Event|Conventional Therapy|Participants continued using their current formulation of inhaled corticosteroid (ICS) and a long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419080|NCT00567476|E1|Reported Event|Omalizumab + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 20 weeks to provide a dose of at least 0.016 mg/kg per UI/ml of immunoglobulin E (IgE). Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued using their current formulation of inhaled corticosteroid (ICS) and long-acting beta 2-adrenergic agonist (LABA). Home use of nebulized beta 2-agonist was allowed for the treatment of symptoms of intercurrent bronchospasm or during an asthma exacerbation if this treatment regimen was already established prior to screening visit.
419081|NCT00567320|B3|Baseline|Total|Total of all reporting groups
419082|NCT00567320|B2|Baseline|Placebo|This is the Placebo condition
419083|NCT00567320|B1|Baseline|Varenicline|Varenicline 2 mg per day.
419084|NCT00567320|P2|Participant Flow|Placebo|This is the Placebo condition
419085|NCT00567320|P1|Participant Flow|Varenicline|Varenicline 2 mg per day.
419086|NCT00567320|O2|Outcome|Placebo|This is the Placebo condition
419087|NCT00567320|O1|Outcome|Varenicline|Varenicline 2 mg per day.
419088|NCT00567320|E2|Reported Event|Placebo|This is the Placebo condition
419089|NCT00567320|E1|Reported Event|Varenicline|Varenicline 2 mg per day.
419090|NCT00567307|B3|Baseline|Total|Total of all reporting groups
419091|NCT00567307|B2|Baseline|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
419092|NCT00567307|B1|Baseline|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
419093|NCT00567307|P2|Participant Flow|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
419094|NCT00567307|P1|Participant Flow|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
419095|NCT00567307|O2|Outcome|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
419096|NCT00567307|O1|Outcome|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
419097|NCT00567307|E2|Reported Event|Standard Practice Group (Arm B)|"Standard Practice~Standard Practice: Arm B received management of their CVD risk according to the usual care given to participants in similar conditions"
419098|NCT00567307|E1|Reported Event|The Polypill Group (Arm A)|"The Polypill Group (Arm A) received a Polypill composed of 75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide~Red Heart Pill 2b (Polypill): Arm A will receive the polypill (Red Heart pill 2b) which is a combination of aspirin (75 mg), simvastatin (20g), lisinopril (10mg) and hydrochlorothiazide (12.5 mg)"
419099|NCT00567268|B1|Baseline|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419100|NCT00567268|P1|Participant Flow|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419101|NCT00567268|O2|Outcome|Absence of Non-Drug Therapy|Participants without non-drug therapy who responded to treatment with gabapentin
419102|NCT00567268|O1|Outcome|Presence of Non-Drug Therapy|Participants with non-drug therapy who responded to treatment with gabapentin
419103|NCT00567268|O6|Outcome|Unkown|Participants with unkown baseline creatinine clearance
419104|NCT00567268|O5|Outcome|CLcr <5 mL/Min|Participants with baseline creatinine clearance <5 mL/min
419105|NCT00567268|O4|Outcome|CLcr >=5 and <15 mL/Min|Participants with baseline creatinine clearance >=5 and <15 mL/min
419106|NCT00567268|O3|Outcome|CLcr >=15 and <30 mL/Min|Participants with baseline creatinine clearance >=15 and <30 mL/min
420209|NCT00564447|P1|Participant Flow|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
419109|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
419110|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
419111|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
419112|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
419113|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
419114|NCT00567268|O3|Outcome|Unknown|Participants with unknown frequency of baseline episodes who responded to the treatment with gabapentin
419115|NCT00567268|O2|Outcome|>8 Episodes|Participants with baseline episodes of epileptic seizure more than 8 who responded to the treatment with gabapentin
419116|NCT00567268|O1|Outcome|<=8 Episodes|Participants with baseline episodes of epileptic seizure below 8 who responded to the treatment with gabapentin
419117|NCT00567268|O3|Outcome|Severe|Participants with severe epilepsy who responded to the treatment with gabapentin
419118|NCT00567268|O2|Outcome|Moderate|Participants with moderate epilepsy who responded to the treatment with gabapentin
419119|NCT00567268|O1|Outcome|Mild|Participants with mild epilepsy who responded to the treatment with gabapentin
419120|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
419121|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age who responded to the treatment with gabapentin
419122|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age who responded to the treatment with gabapentin
419123|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age who responded to the treatment with gabapentin
419124|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age who responded to the treatment with gabapentin
419125|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age who responded to the treatment with gabapentin
419126|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age who responded to the treatment with gabapentin
419127|NCT00567268|O2|Outcome|Age >=65 Years|Participants >=65 years of age who responded to the treatment with gabapentin
419128|NCT00567268|O1|Outcome|Age <65 Years|Participants <65 years of age who responded to the treatment with gabapentin
419129|NCT00567268|O5|Outcome|Four or More Concomitant Antiepileptic Drugs|Participants taking four or more concomitant antiepileptic drugs at baseline
419130|NCT00567268|O4|Outcome|Three Concomitant Antiepileptic Drugs|Participants taking three concomitant antiepileptic drugs at baseline
419131|NCT00567268|O3|Outcome|Two Concomitant Antiepileptic Drugs|Participants taking two concomitant antiepileptic drugs at baseline
419132|NCT00567268|O2|Outcome|One Concomitant Antiepileptic Drug|Participants taking one concomitant antiepileptic drug at baseline
419133|NCT00567268|O1|Outcome|No Concomitant Antiepileptic Drug|Participants taking no concomitant antiepileptic drug at baseline
419134|NCT00567268|O7|Outcome|Age >=65 Years|Participants >=65 years years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419135|NCT00567268|O6|Outcome|Age >=55 and <65 Years|Participants >=55 and <65 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419136|NCT00567268|O5|Outcome|Age >=45 and <55 Years|Participants >=45 and <55 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419137|NCT00567268|O4|Outcome|Age >=35 and <45 Years|Participants >=35 and <45 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419138|NCT00567268|O3|Outcome|Age >=25 and <35 Years|Participants >=25 and <35 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419139|NCT00567268|O2|Outcome|Age >=15 and <25 Years|Participants >=15 and <25 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419140|NCT00567268|O1|Outcome|Age <15 Years|Participants <15 years of age taking gabapentin oral tablets 200, 300, or 400 mg according to the Japanese package insert
419141|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419142|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419143|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419144|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419202|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419203|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
419145|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419146|NCT00567268|O1|Outcome|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419147|NCT00567268|E1|Reported Event|Gabapentin 200, 300, 400 mg Tablets|The usual dosage of gabapentin in adults and children aged 13 or older was as follows: oral gabapentin 600 mg, 3 div., was administered on day 1 and an effective dose of 1200 mg, 3 div., was administered on day 2. From day 3 on, oral gabapentin 1200 mg to 1800 mg, 3 div., was administered as the maintenance dose. Subsequently, the maintenance dose was suitably adjusted depending on the symptoms (up to a maximum daily dose of 2400 mg).
419148|NCT00567255|B3|Baseline|Total|Total of all reporting groups
419149|NCT00567255|B2|Baseline|Placebo|Placebo
419150|NCT00567255|B1|Baseline|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419151|NCT00567255|P2|Participant Flow|Placebo|Placebo
419152|NCT00567255|P1|Participant Flow|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419153|NCT00567255|O2|Outcome|Placebo|Placebo
419154|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419155|NCT00567255|O2|Outcome|Placebo|Placebo
419156|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419157|NCT00567255|O2|Outcome|Placebo|Placebo
419158|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419159|NCT00567255|O2|Outcome|Placebo|Placebo
419160|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419161|NCT00567255|O2|Outcome|Placebo|Placebo
419162|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419163|NCT00567255|O2|Outcome|Placebo|Placebo
419164|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419165|NCT00567255|O2|Outcome|Placebo|Placebo
419166|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419167|NCT00567255|O2|Outcome|Placebo|Placebo
419168|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419169|NCT00567255|O2|Outcome|Placebo|Placebo
419170|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419171|NCT00567255|O2|Outcome|Placebo|Placebo
419172|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419173|NCT00567255|O2|Outcome|Placebo|Placebo
419174|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419175|NCT00567255|O2|Outcome|Placebo|Placebo
419176|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419177|NCT00567255|O2|Outcome|Placebo|Placebo
419178|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419179|NCT00567255|O2|Outcome|Placebo|Placebo
419180|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419181|NCT00567255|O2|Outcome|Placebo|Placebo
419182|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419183|NCT00567255|O2|Outcome|Placebo|Placebo
419184|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419185|NCT00567255|O2|Outcome|Placebo|Placebo
419186|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419187|NCT00567255|O2|Outcome|Placebo|Placebo
419188|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419189|NCT00567255|O2|Outcome|Placebo|Placebo
419190|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419191|NCT00567255|O2|Outcome|Placebo|Placebo
419192|NCT00567255|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/day
419193|NCT00567255|E2|Reported Event|Placebo|Placebo
419194|NCT00567255|E1|Reported Event|NB32/48|"Naltrexone SR 32 mg/bupropion SR 360 mg/day or naltrexone SR 48 mg/bupropion SR 360 mg/day~Beginning at Week 28 through Week 44, NB32-treated subjects who failed to achieve or maintain at least 5% body weight loss from baseline were re-randomized (1:1 ratio) to continue NB32 or begin treatment with a higher dose of naltrexone SR - naltrexone SR 48 mg/bupropion SR 360 mg (referred to as NB48) (daily dose of bupropion SR was 360 mg for NB32 and NB48).~NB32/48 group includes all participants in the safety analysis set randomized to NB32 at baseline, regardless of re-randomization status."
419195|NCT00567242|B3|Baseline|Total|Total of all reporting groups
419196|NCT00567242|B2|Baseline|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419197|NCT00567242|B1|Baseline|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
419198|NCT00567242|P2|Participant Flow|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419199|NCT00567242|P1|Participant Flow|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
419200|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419201|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
420210|NCT00564447|O8|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
419204|NCT00567242|O2|Outcome|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419205|NCT00567242|O1|Outcome|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
419206|NCT00567242|E2|Reported Event|Word-finding With no Intention Manipulation|Word-finding trials similar to intention mediated treatment, but without intention manipulation
419207|NCT00567242|E1|Reported Event|Word-finding With Intention Manipulation|Treats word-finding (picture naming, category member generation) with an intention manipulation (complex left-hand movement to initiate word-finding trials)
419208|NCT00567229|B1|Baseline|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
419209|NCT00567229|P1|Participant Flow|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
419210|NCT00567229|O1|Outcome|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
419211|NCT00567229|E1|Reported Event|Lenalidomide and Rituximab|This study will employ a Simon optimal two-stage design. Patients will receive lenalidomide 25 mg daily for days 1-21 of each 28 day cycle. Rituximab 375 mg/m2 will be given weekly for 4 weeks beginning 1 week after the start of lenalidomide therapy (weeks 2-5), and then once 8 weeks later (week 13). Patients with stable disease or better after 4 cycles (week 16, in the absence of delays for toxicity) will be able to continue on therapy on the same lenalidomide schedule and with rituximab 375 mg/m2 given once every 8 weeks.
419212|NCT00567190|B3|Baseline|Total|Total of all reporting groups
419213|NCT00567190|B2|Baseline|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419214|NCT00567190|B1|Baseline|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419215|NCT00567190|P2|Participant Flow|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419216|NCT00567190|P1|Participant Flow|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419217|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419218|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419219|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419220|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419221|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419222|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419223|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419224|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419225|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419226|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419227|NCT00567190|O2|Outcome|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419228|NCT00567190|O1|Outcome|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419229|NCT00567190|E3|Reported Event|Crossover From Placebo to Pertuzumab|Forty-eight of 406 patients (11.8%) randomized to the placebo treatment group whose disease had not progressed crossed over to an open-label pertuzumab treatment group between July 2012 and November 2012. Patients received pertuzumab administered as an IV loading dose of 840 mg at cycle 1 then 420 mg IV every q3w until investigator-assessed radiographic or clinical evidence of PD, unacceptable toxicity, or withdrawal of consent. Trastuzumab and docetaxel doses continued in accordance with the pre-crossover placebo treatment regimens and according to dosing specifications indicated in the study protocol.
422613|NCT00558428|E1|Reported Event|Amlodipine 5mg|
419230|NCT00567190|E2|Reported Event|Pertuzumab + Trastuzumab + Docetaxel|Patients received pertuzumab 420 mg intravenously (IV) every 3 weeks (q3w) plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles.
419231|NCT00567190|E1|Reported Event|Placebo + Trastuzumab + Docetaxel|Patients received placebo IV q3w plus trastuzumab 6 mg/kg IV q3w plus docetaxel 75 mg/m^2 IV q3w for at least 6 cycles. For the 48 patients that crossed over to the pertuzumab treatment group, AEs were analyzed from the day of their first placebo dose (Day 1) through the day just prior to their first pertuzumab dose. Any AEs occurring on, or after, the day of their first dose of pertuzumab were included in the Crossover treatment group analysis.
419232|NCT00567164|B4|Baseline|Total|Total of all reporting groups
419233|NCT00567164|B3|Baseline|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419234|NCT00567164|B2|Baseline|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419235|NCT00567164|B1|Baseline|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419236|NCT00567164|P3|Participant Flow|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419237|NCT00567164|P2|Participant Flow|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419238|NCT00567164|P1|Participant Flow|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419239|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419240|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419241|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419242|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419256|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419349|NCT00566982|B1|Baseline|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419243|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419244|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419245|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419246|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419247|NCT00567164|O1|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419248|NCT00567164|O2|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419249|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419250|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419251|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419252|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419253|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419254|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419255|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419257|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419258|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419259|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419260|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419261|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419262|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419263|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419264|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419265|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419266|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419267|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419268|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419335|NCT00567008|B1|Baseline|Varenicline|Varenicline (Chantix)
419336|NCT00567008|P2|Participant Flow|Placebo|Placebo
419337|NCT00567008|P1|Participant Flow|Varenicline 2mg/Day|Varenicline (Chantix)
419338|NCT00567008|O2|Outcome|Placebo|Placebo
419269|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419270|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419271|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419272|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419273|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419274|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419275|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419276|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419277|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419278|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419279|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419280|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419339|NCT00567008|O1|Outcome|Varenicline|Varenicline (Chantix)
419340|NCT00567008|E2|Reported Event|Placebo|Placebo
419341|NCT00567008|E1|Reported Event|Varenicline|Varenicline (Chantix)
419395|NCT00566943|O1|Outcome|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419281|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419282|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419283|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419284|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419285|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419286|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419287|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419288|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419289|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419290|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419291|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419292|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419342|NCT00566995|B1|Baseline|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
419343|NCT00566995|P1|Participant Flow|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
419293|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419294|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419295|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419296|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419297|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419298|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419299|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419300|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419301|NCT00567164|O3|Outcome|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419302|NCT00567164|O2|Outcome|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419303|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419344|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
419345|NCT00566995|O1|Outcome|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
419346|NCT00566995|E1|Reported Event|Vandetanib in Participants With Kidney Cancer|300 mg/day (starting dose) oral dose of vandetanib once a day for 28 days
419347|NCT00566982|B3|Baseline|Total|Total of all reporting groups
419348|NCT00566982|B2|Baseline|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419304|NCT00567164|O2|Outcome|Pooled Analysis of Flexible Regimen no. 1 and Regimen no. 2|Pooled FAS of Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300) (see first arm) and Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300). Regimen no. 2: Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419305|NCT00567164|O1|Outcome|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419306|NCT00567164|E3|Reported Event|Conventional Regimen of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets of BAY86-5300 (YAZ, SH T00186D) followed by 4 days of placebo tablets (SH T470PD). 13 withdrawal bleeding episodes during one year of treatment were expected.
419307|NCT00567164|E2|Reported Event|Flexible (Extended) Regimen no. 2 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) uninterrupted treatment with one tablet daily of BAY86-5300 (SH T00186D) and a 4-day tablet-free interval. Subjects were permitted to schedule their withdrawal bleeding (ie, 4-day tablet-free interval) at any time between days 25 to 120 of the cycle. Subjects had the option to follow the bleeding rules of the flexible (extended) regimen no. 1 of BAY86-5300. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
419308|NCT00567164|E1|Reported Event|Flexible (Extended) Regimen no. 1 of EE20/DRSP (BAY86-5300)|Minimum of 3 cycles of treatment, each cycle comprising 120 days (maximum) intended treatment with one tablet daily of BAY86-5300 (SH T00186D) followed by a 4-day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred between days 25 to 120 of the treatment cycle, a 4-day tablet-free interval was advised. The minimum period between 2 tablet-free intervals was 24 days. After each 4-day tablet-free interval, a new 124-day intended treatment cycle was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment
419309|NCT00567112|B1|Baseline|All Randomized|Includes the 15 participants who were randomized and started the study in Treatment Period 1 (Baseline) and the 3 additional participants who were subsequently randomized and started the study in Treatment Period 2.
419310|NCT00567112|P3|Participant Flow|Treatment Group BCD|"Period 1: Not Applicable~Period 2: OCT (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
419311|NCT00567112|P2|Participant Flow|Treatment Group BACD|"Period 1: OCT (fasted)~Period 2: DFC (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
419312|NCT00567112|P1|Participant Flow|Treatment Group ABCD|"Period 1: Dry Filled Capsule (DFC) (fasted)~Period 2: Oral Compressed Tablet (OCT) (fasted)~Period 3: OCT (after meal)~Period 4: OCT (before meal)"
419313|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
419314|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419315|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
419316|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419317|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
419318|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419319|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
419320|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419321|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
419322|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419323|NCT00567112|O2|Outcome|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
419324|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419325|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
419326|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419327|NCT00567112|O2|Outcome|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
419328|NCT00567112|O1|Outcome|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419329|NCT00567112|E4|Reported Event|DFC (Fasted)|Participants receiving a single dose of 10 mg MK-0941 DFC administered in a fasted state
419330|NCT00567112|E3|Reported Event|OCT (Before Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered before consumption of a standard breakfast
419331|NCT00567112|E2|Reported Event|OCT (After Meal)|Participants receiving a single dose of 10 mg MK-0941 OCT administered after consumption of a high-fat meal
419332|NCT00567112|E1|Reported Event|OCT (Fasted)|Participants receiving a single dose of 10 mg MK-0941 OCT administered in a fasted state
419333|NCT00567008|B3|Baseline|Total|Total of all reporting groups
419334|NCT00567008|B2|Baseline|Placebo|Placebo
419350|NCT00566982|P2|Participant Flow|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419351|NCT00566982|P1|Participant Flow|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419352|NCT00566982|O4|Outcome|Subjects on Ospemifene 60 mg/Day (Week 52)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419353|NCT00566982|O3|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419354|NCT00566982|O2|Outcome|Subjects on Placebo (Week 52)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419355|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419356|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419357|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419358|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419359|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419360|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419361|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419362|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419363|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419364|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419365|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419366|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419367|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419368|NCT00566982|O2|Outcome|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419369|NCT00566982|O1|Outcome|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419370|NCT00566982|E2|Reported Event|Subjects on Ospemifene 60 mg/Day (Baseline)|Ospemifene was taken orally, once daily, in the morning, with food for 52 weeks.
419371|NCT00566982|E1|Reported Event|Subjects on Placebo (Baseline)|Placebo was taken orally, once daily, in the morning, with food for 52 weeks.
419372|NCT00566969|B4|Baseline|Total|Total of all reporting groups
419373|NCT00566969|B3|Baseline|Carvedilol 50 mg|"To be compared to placebo and Carvedilol 25 mg~Carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
419374|NCT00566969|B2|Baseline|Carvedilol 25 mg|"To be compared to placebo and Carvedilol 50 mg~carvedilol: subjects randomized to placebo, carvedilol 25mg or 50mg"
419375|NCT00566969|B1|Baseline|Sugar Pill|"To be compared to active drug~sugar pill: Subjects randomized to placebo, carvedilol 25mg or 50mg"
419376|NCT00566969|P3|Participant Flow|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419377|NCT00566969|P2|Participant Flow|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419378|NCT00566969|P1|Participant Flow|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
419379|NCT00566969|O3|Outcome|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419380|NCT00566969|O2|Outcome|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419381|NCT00566969|O1|Outcome|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
419382|NCT00566969|E3|Reported Event|Carvedilol 50 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419383|NCT00566969|E2|Reported Event|Carvedilol 25 mg|"To be compared to sugar pill~carvedilol: randomly assigned to 25mg or 50mg of Carvedilol or sugar pill, dose determined by height and weight."
419384|NCT00566969|E1|Reported Event|Sugar Pill|"To be compared to active drug~sugar pill: randomly given 25mg or 50mg of a sugar pill or the active comparator"
419385|NCT00566943|B3|Baseline|Total|Total of all reporting groups
419386|NCT00566943|B2|Baseline|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
419387|NCT00566943|B1|Baseline|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419388|NCT00566943|P2|Participant Flow|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
419389|NCT00566943|P1|Participant Flow|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419390|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm|PSD Veritas is used as a buttress on stomach and/or GJ anastomosis.
419391|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines
419392|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Arm Linear|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
419393|NCT00566943|O1|Outcome|Number of Subjects in Control Arm|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419394|NCT00566943|O2|Outcome|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
419396|NCT00566943|O2|Outcome|Number of Subjects in PSD Veritas Group|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis.
419397|NCT00566943|O1|Outcome|Number of Subjects in Control Group|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419398|NCT00566943|E2|Reported Event|PSD Veritas|PSD Veritas is used as a buttress for staple lines of the stomach and/or GJ anastomosis. Linear and circular refer to the shapes of the Veritas.
419399|NCT00566943|E1|Reported Event|Control|control arm where no buttress is used on stomach or GJ anastomosis staple lines.
419400|NCT00566930|B4|Baseline|Total|Total of all reporting groups
419401|NCT00566930|B3|Baseline|Spinal Manipulation and Exercises|Spinal manipulation + exercises
419402|NCT00566930|B2|Baseline|Spinal Manipulation|spinal manipulation
419403|NCT00566930|B1|Baseline|Control|control group with no treatment only regular assessment appointments
419404|NCT00566930|P3|Participant Flow|Spinal Manipulation and Exercises|Spinal manipulation + exercises
419405|NCT00566930|P2|Participant Flow|Spinal Manipulation|spinal manipulation
419406|NCT00566930|P1|Participant Flow|Control|control group with no treatment only regular assessment appointments
419407|NCT00566930|O3|Outcome|Spinal Manipulation and Exercises|Spinal manipulation + exercises
419408|NCT00566930|O2|Outcome|Spinal Manipulation|spinal manipulation
419409|NCT00566930|O1|Outcome|Control|control group with no treatment only regular assessment appointments
419410|NCT00566930|E3|Reported Event|Spinal Manipulation and Exercises|Spinal manipulation + exercises
419411|NCT00566930|E2|Reported Event|Spinal Manipulation|spinal manipulation
419412|NCT00566930|E1|Reported Event|Control|control group with no treatment only regular assessment appointments
419413|NCT00566735|B3|Baseline|Total|Total of all reporting groups
419414|NCT00566735|B2|Baseline|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419415|NCT00566735|B1|Baseline|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419416|NCT00566735|P2|Participant Flow|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419417|NCT00566735|P1|Participant Flow|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419418|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419419|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419420|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419421|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419422|NCT00566735|O2|Outcome|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419423|NCT00566735|O1|Outcome|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419424|NCT00566735|E2|Reported Event|Galantamine|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received galantamine tablets 4 milligrams twice daily (increased every three days until a target of 8 milligrams twice daily) and treatment-as-usual electroconvulsive therapy.
419425|NCT00566735|E1|Reported Event|Placebo|Patients with major depression, bipolar disorder (depressed type) or schizoaffective disorder (depressed type) received placebo (sugar pills) and treatment-as-usual electroconvulsive therapy.
419426|NCT00566722|B4|Baseline|Total|Total of all reporting groups
419427|NCT00566722|B3|Baseline|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419428|NCT00566722|B2|Baseline|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419573|NCT00566111|P2|Participant Flow|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419429|NCT00566722|B1|Baseline|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419430|NCT00566722|P3|Participant Flow|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419431|NCT00566722|P2|Participant Flow|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419432|NCT00566722|P1|Participant Flow|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419433|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419434|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419435|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419436|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419437|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419482|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419483|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419438|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419439|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419440|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419441|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419442|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419443|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419444|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419445|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419446|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419484|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419485|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419447|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419448|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419449|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419450|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419451|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419452|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419453|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419454|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419455|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419486|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419487|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419456|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419457|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419458|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419459|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419460|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419461|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419462|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419463|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|
419464|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|
419465|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|
419466|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419467|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419488|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419468|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419469|NCT00566722|O3|Outcome|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419470|NCT00566722|O2|Outcome|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419471|NCT00566722|O1|Outcome|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419472|NCT00566722|E3|Reported Event|Sub-optimal Response to Etanercept|Etanercept treatment must have been administered for at least 6 consecutive months (or at least 3 consecutive months with deterioration of efficacy observed during the 3 months) prior to Screening, with no treatment interruptions except for toxicity or intolerability, at doses of 50 mg every other week, 50 mg every week, or 25 mg every other week. A treatment interruption due to toxicity or intolerability could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability, the participant was not eligible. The last dose of etanercept must have been at least 11 days but not more than 17 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419473|NCT00566722|E2|Reported Event|Sub-optimal Response to Narrow-band Ultraviolet-B|NB-UVB must have been administered for at least 2 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last treatment with NB UV-B must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as Physician's Global Assessment of moderate (3) or worse.
419474|NCT00566722|E1|Reported Event|Sub-optimal Response to MTX|MTX treatment must have been administered for at least 4 consecutive months prior to Screening, with no treatment interruptions except for toxicity or intolerability. If there had been a treatment interruption due to toxicity or intolerability, the length of treatment interruption could not have exceeded 14 days. If there was more than one treatment interruption due to toxicity or intolerability (regardless of the length of the treatment interruptions), the participant was not eligible. The last dose of methotrexate must have been at least 4 days but not more than 10 days before the first dose of adalimumab. Suboptimal response was defined as a Physician's Global Assessment of mild (2) or worse.
419475|NCT00566709|B3|Baseline|Total|Total of all reporting groups
419476|NCT00566709|B2|Baseline|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419477|NCT00566709|B1|Baseline|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419478|NCT00566709|P2|Participant Flow|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419479|NCT00566709|P1|Participant Flow|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419480|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419481|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419567|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
419568|NCT00566150|E2|Reported Event|Placebo|Subjects assigned to placebo control group.
419489|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419490|NCT00566709|O2|Outcome|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419491|NCT00566709|O1|Outcome|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419492|NCT00566709|E2|Reported Event|RBCT Based on Hemoglobin Level Value|"Intervention: In the hemoglobin – strategy group, patients will be transfused to reach post-transfusion hemoglobin levels between 8.5 g/dL and 10 g/dL.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419493|NCT00566709|E1|Reported Event|RBCT Based on rSO2 Value|"Intervention: In the rSO2 - strategy group, patients will be transfused to attain a post-transfusion rSO2 values higher than 60%.~Red blood cells transfusion: Patients will be transfused (one to one red blood cells unit transfusion)"
419494|NCT00566696|B1|Baseline|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419495|NCT00566696|P1|Participant Flow|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419496|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419497|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419498|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419499|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419500|NCT00566696|O1|Outcome|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419501|NCT00566696|E1|Reported Event|High-Risk Hematologic Malignancies|Participants meeting eligibility criteria and who underwent haploidentical stem cell transplantation with systemic chemotherapy and antibodies, including Fludarabine, Thioplex®, L-phenylalanine mustard, mycophenolate mofetil, CellCept®, Rituxan™, Muromonab (prior to January 2010) or Alemtuzumab (beginning January 2010), Cyclophosphamide, Anti-thymocyte globulin (Rabbit), and G-CSF.
419502|NCT00566631|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419503|NCT00566631|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419504|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419505|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419506|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419507|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419569|NCT00566150|E1|Reported Event|Levetiracetam|Subjects on active study medication.
419570|NCT00566111|B3|Baseline|Total|Total of all reporting groups
422614|NCT00558363|B3|Baseline|Total|Total of all reporting groups
419508|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419509|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419510|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419511|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419512|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419513|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419514|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419515|NCT00566631|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419516|NCT00566631|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER tablet in flexible daily dose of 3, 6, 9 or 12 milligram (mg) as per Investigators’ discretion was given once daily orally for 6 weeks in the core treatment phase and no longer than 12 months in the extension phase after the completion of core treatment phase.
419517|NCT00566579|B3|Baseline|Total|Total of all reporting groups
419518|NCT00566579|B2|Baseline|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419519|NCT00566579|B1|Baseline|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419520|NCT00566579|P2|Participant Flow|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419521|NCT00566579|P1|Participant Flow|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419522|NCT00566579|O2|Outcome|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419523|NCT00566579|O1|Outcome|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419524|NCT00566579|E2|Reported Event|Observation|Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419525|NCT00566579|E1|Reported Event|Cryotherapy|Double-freezing cryotherapy was done within one month after the primary hpv testing was positive. Pap smear and colposcopy were done at 6 months and 12 months. HPV testing was repeated again at 12 months.
419526|NCT00566501|B3|Baseline|Total|Total of all reporting groups
419527|NCT00566501|B2|Baseline|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419528|NCT00566501|B1|Baseline|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419529|NCT00566501|P2|Participant Flow|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419530|NCT00566501|P1|Participant Flow|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419531|NCT00566501|O2|Outcome|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419532|NCT00566501|O1|Outcome|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419533|NCT00566501|E2|Reported Event|10 mg IR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419534|NCT00566501|E1|Reported Event|23 mg SR in Study 326|Donepezil SR 23 mg once daily orally for 12 months to patients who either (a) received donepezil 23 mg SR in the preceding double-blind study E2020-G000-326, or (b) received donepezil 10 mg IR in that study.
419571|NCT00566111|B2|Baseline|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419572|NCT00566111|B1|Baseline|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419535|NCT00566462|B1|Baseline|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
419536|NCT00566462|P1|Participant Flow|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
419537|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
419538|NCT00566462|O1|Outcome|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
419539|NCT00566462|E1|Reported Event|Perampanel|A single dose carbidopa/levodopa (37.5mg/150mg PO) challenge at Baseline, followed by one 2-mg tablet/day PO of Perampanel for 14 days, then two 2-mg tablets/day (4-mg/day)PO of Perampanel for 14 days, followed by a single dose carbidopa/levodopa (37.5mg/150mg PO) challenge after 4 weeks.
419540|NCT00566254|B3|Baseline|Total|Total of all reporting groups
419541|NCT00566254|B2|Baseline|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419542|NCT00566254|B1|Baseline|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419543|NCT00566254|P2|Participant Flow|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419544|NCT00566254|P1|Participant Flow|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419545|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419546|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419547|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419548|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419549|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419550|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419551|NCT00566254|O2|Outcome|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419552|NCT00566254|O1|Outcome|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419553|NCT00566254|E2|Reported Event|Zonisamide|Participants had a starting dose of 1 mg/kg/day of Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419554|NCT00566254|E1|Reported Event|Placebo|Participants had a starting dose of 1 mg/kg/day of placebo matching Zonisamide. Dose was titrated upwards with weekly dose increases until a dose of 8 mg/kg/day was reached at the end of the Titration Period (Week 8). Dose during the Maintenance Period remained unchanged from Week 8.
419555|NCT00566150|B3|Baseline|Total|Total of all reporting groups
419556|NCT00566150|B2|Baseline|Placebo|Subjects assigned to placebo control group.
419557|NCT00566150|B1|Baseline|Levetiracetam|Subjects on active study medication.
419558|NCT00566150|P2|Participant Flow|Placebo|Subjects assigned to placebo control group.
419559|NCT00566150|P1|Participant Flow|Levetiracetam|Subjects on active study medication.
419560|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
419561|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
419562|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
419563|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
419564|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
419565|NCT00566150|O1|Outcome|Levetiracetam|Subjects on active study medication.
419566|NCT00566150|O2|Outcome|Placebo|Subjects assigned to placebo control group.
419574|NCT00566111|P1|Participant Flow|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419575|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419576|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419577|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419578|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419579|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419580|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419581|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419582|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419583|NCT00566111|O2|Outcome|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419584|NCT00566111|O1|Outcome|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419585|NCT00566111|E2|Reported Event|Placebo|Saline solution: Saline solution will be administered IV via midline, 7 days a week for 4 weeks.
419586|NCT00566111|E1|Reported Event|Ceftriaxone|ceftriaxone: 2g per day which will be administered IV via midline, 7 days a week for 4 weeks.
419587|NCT00566020|B1|Baseline|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419588|NCT00566020|P2|Participant Flow|Lamotrigine - Long-term Administration Phase|Lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419589|NCT00566020|P1|Participant Flow|Lamotrigine - Dosage Adjustment Phase|Lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation
419590|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419591|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419592|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419593|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419594|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419595|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419596|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419597|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419598|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419599|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419600|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419601|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419602|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419603|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419604|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419605|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419606|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419607|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419608|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419609|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419610|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419611|NCT00566020|O1|Outcome|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 milligrams per day (mg/day) to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419612|NCT00566020|E1|Reported Event|Lamotrigine|Dosage-adjustment Phase: lamotrigine 12.5 mg/day to 200 mg/day for 6 weeks without any concomitant use of medication that induces lamotrigine glucuronidation; followed by Long-term Administration Phase: lamotrigine 50 mg/day to 400 mg/day for 46 weeks depending on concomitant use of medication that induces or inhibits lamotrigine glucuronidation
419613|NCT00565812|B4|Baseline|Total|Total of all reporting groups
419614|NCT00565812|B3|Baseline|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419615|NCT00565812|B2|Baseline|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419616|NCT00565812|B1|Baseline|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419617|NCT00565812|P3|Participant Flow|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419618|NCT00565812|P2|Participant Flow|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419619|NCT00565812|P1|Participant Flow|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419620|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419621|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419622|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419623|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419624|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419625|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419626|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419627|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419628|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419629|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419630|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419759|NCT00565747|P1|Participant Flow|Test Culture|Culture with 2 ng/ml GM-CSF
419631|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419632|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419633|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419634|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419635|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419636|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419637|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419638|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419639|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419640|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419641|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419642|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419643|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419644|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419645|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419646|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419647|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419648|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419649|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419650|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419651|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419652|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419653|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419654|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419655|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419656|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419657|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419658|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419659|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419660|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419661|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419662|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419663|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419664|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419665|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419666|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419667|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419668|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419669|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419670|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419671|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419672|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419760|NCT00565747|O2|Outcome|Control Culture|Culture without GM-CSF
419673|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419674|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419675|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419676|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419677|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419678|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419679|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419680|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419681|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419682|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419683|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419684|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419685|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419686|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419687|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419688|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419689|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419690|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419691|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419692|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419693|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419694|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419695|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419696|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419697|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419698|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419699|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419700|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419701|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419702|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419703|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419704|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419705|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419706|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419707|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419708|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419709|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419710|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419711|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419712|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419713|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419714|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419761|NCT00565747|O1|Outcome|Test Culture|Culture with 2 ng/ml GM-CSF
419715|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419716|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419717|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419718|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419719|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419720|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419721|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419722|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419723|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419724|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419725|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419726|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419727|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419728|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419729|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419730|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419731|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419732|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419733|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419734|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419735|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419736|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419737|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419738|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419739|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419740|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419741|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419742|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419743|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419744|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419745|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419746|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419747|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419748|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419749|NCT00565812|O3|Outcome|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419750|NCT00565812|O2|Outcome|SD-0610 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419751|NCT00565812|O1|Outcome|SD-0610 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419752|NCT00565812|E3|Reported Event|Placebo|Participants with symptomatic OA of knee, received placebo matched to SD-6010 orally, once daily for 24 months.
419753|NCT00565812|E2|Reported Event|SD-6010 200 mg|Participants with symptomatic OA of knee, received 200 mg tablet of SD-6010 orally, once daily for 24 months.
419754|NCT00565812|E1|Reported Event|SD-6010 50 Milligram (mg)|Participants with symptomatic osteoarthritis (OA) of knee, received 50 mg tablet of SD-6010 orally, once daily for 24 months.
419755|NCT00565747|B3|Baseline|Total|Total of all reporting groups
419756|NCT00565747|B2|Baseline|Control Culture|Culture without GM-CSF
419757|NCT00565747|B1|Baseline|Test Culture|Culture with 2 ng/ml GM-CSF
419758|NCT00565747|P2|Participant Flow|Control Culture|Culture without GM-CSF
419768|NCT00565721|B1|Baseline|Safety With Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
419769|NCT00565721|P1|Participant Flow|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
419770|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
419771|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
419772|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
419773|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Renal Cell Carcinoma (RCC) subjects. Correlation strength was defined descriptively.
419774|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
419775|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ5 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention by tumor tissue following intravenous administration of AH111585 (18F) Injection for the Full Analysis Set (FAS) subjects. Correlation strength was defined descriptively.
419776|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
419777|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
419778|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
419779|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ3 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
419780|NCT00565721|O1|Outcome|Correlation Between SUVR_55_blood and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
419781|NCT00565721|O1|Outcome|Correlation Between SUVw_55 and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
419782|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Renal Cell Carcinoma (RCC) subjects.
419783|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak αvβ5 Optical Density|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)). Correlation of the Magnitude of [18F]Fluciclatide Uptake and Retention with Quantitative Measurement of the Levels of αvβ5 Integrin Expression in Tumors for the Full Analysis Set (FAS) subjects.
419784|NCT00565721|O1|Outcome|Correlation Between VT_inp-Logan and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
419785|NCT00565721|O1|Outcome|Correlation Between Ki_inp-Patlak and αvβ3 Optical Density|Correlation between Imaging parameters. The selected imaging parameters that reflected (18F) Fluciclatide tracer uptake and retention.
419786|NCT00565721|E1|Reported Event|Fluciclatide Injection|The patient would receive an injection of Fluciclatide (GE-135) (F18) at 10mCi (370 megabecquerels (MBq)).
419787|NCT00565643|B3|Baseline|Total|Total of all reporting groups
419788|NCT00565643|B2|Baseline|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419789|NCT00565643|B1|Baseline|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
419790|NCT00565643|P2|Participant Flow|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419791|NCT00565643|P1|Participant Flow|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
419792|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419793|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
419794|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419795|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
419796|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419797|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
419798|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419799|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
419800|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419801|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of initial cesarean delivery
419802|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419803|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
419804|NCT00565643|O2|Outcome|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419805|NCT00565643|O1|Outcome|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
419806|NCT00565643|E2|Reported Event|Routine Closure Group|Placebo: Routine abdominal closure without placement of adhesion barrier
419807|NCT00565643|E1|Reported Event|HA-CMC Group|modified sodium hyaluronic acid and carboxymethylcellulose (Seprafilm Adhesion Barrier): Adhesion barrier applied at the time of cesarean delivery
419808|NCT00565604|B1|Baseline|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419809|NCT00565604|P1|Participant Flow|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419810|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419811|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419812|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419813|NCT00565604|O1|Outcome|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419814|NCT00565604|E1|Reported Event|Short Catheter Delivery|Patients with duplex ultrasound documented incompetent perforator veins will be treated using a short catheter delivery system in conjunction with a Bright Tip Laser fiber.
419815|NCT00565461|B5|Baseline|Total|Total of all reporting groups
419816|NCT00565461|B4|Baseline|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419817|NCT00565461|B3|Baseline|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419818|NCT00565461|B2|Baseline|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419819|NCT00565461|B1|Baseline|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419820|NCT00565461|P4|Participant Flow|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419821|NCT00565461|P3|Participant Flow|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419822|NCT00565461|P2|Participant Flow|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419823|NCT00565461|P1|Participant Flow|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419824|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
419825|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
419826|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
419827|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
420211|NCT00564447|O7|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
419828|NCT00565461|O2|Outcome|Self Administered (In-clinic & Non-clinic)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: self-administration either in-clinic or away from the clinic; location: thigh"
419829|NCT00565461|O1|Outcome|Clinician Administered (Deltoid/ Thigh)|"st vaccination: administered by clinician; location: deltoid~nd vaccination: administered by clinician; location: thigh"
419830|NCT00565461|E4|Reported Event|Self Administered (Non-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will have 37.5ug LT patch on the left deltoid by a clinician. Two weeks later subjects will have the same treatment repeated by self-application at home on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419831|NCT00565461|E3|Reported Event|Self Administered (In-clinic)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT on the left deltoid by the clinician. Two weeks later subject will have the same treatment repeated by self-application in the clinic on the left thigh.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419832|NCT00565461|E2|Reported Event|Clinician Administered (Thigh)|"40 subjects will be pretreated with SPS:Buffer and a patch containing 37.5ug will be applied on the left deltoid by the Clinician. Fourteen days later, the same procedure will occur on the left thigh by the clinician.~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419833|NCT00565461|E1|Reported Event|Clinician Administered (Deltoid)|"40 subjects will have skin prepared using SPS:Buffer and will receive 37.5ug LT patch on the left deltoid by a Clinician on Day 0. Two weeks later will have the same treatment repeated on the right deltoid by the clinician~heat-labile enterotoxin of E. coli (LT): 37.5ug patch applied on either the deltoid or the thigh"
419834|NCT00565448|B3|Baseline|Total|Total of all reporting groups
419835|NCT00565448|B2|Baseline|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419836|NCT00565448|B1|Baseline|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419837|NCT00565448|P2|Participant Flow|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419838|NCT00565448|P1|Participant Flow|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419839|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
419840|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
419841|NCT00565448|O2|Outcome|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
419842|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation Treatment: Radiation for 6 weeks and 3 cycles of platinum 100 mg/m² every 3 weeks."
419843|NCT00565448|O1|Outcome|Docetaxel/Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
419844|NCT00565448|O2|Outcome|Cisplatin/5-FU|Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
419845|NCT00565448|O1|Outcome|Docetaxel /Cisplatin/5-FU|Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy
419846|NCT00565448|E2|Reported Event|Docetaxel /Cisplatin/5-FU|"Docetaxel 75 mg/m² in combination with Cisplatin 75 mg/m² on Day 1 and 5-Fluorouracil 750 mg/m²/day on Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419847|NCT00565448|E1|Reported Event|Cisplatin/5-FU|"Cisplatin 80 mg/m² on Day 1 and 5-Fluorouracil 1000 mg/m²/day Days 1 to 4 every 3 weeks as induction therapy.~Consolidation treatment: radiation therapy for 7-8 weeks and 3 cycles of cisplatin 100 mg/m² every 3 weeks."
419848|NCT00565409|B1|Baseline|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419849|NCT00565409|P4|Participant Flow|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
419850|NCT00565409|P3|Participant Flow|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
419851|NCT00565409|P2|Participant Flow|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
419852|NCT00565409|P1|Participant Flow|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419900|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419853|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419854|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419855|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419856|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419857|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419858|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419859|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419860|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419861|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419862|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419863|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419864|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419865|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419866|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419867|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419868|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419869|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419870|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419871|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419872|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419873|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419874|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419875|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419876|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419877|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419878|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419879|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419880|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419881|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419882|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419883|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419884|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419885|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419886|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419887|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419888|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419889|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419890|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419891|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419892|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419893|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419894|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419895|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419896|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419897|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419898|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419899|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
420212|NCT00564447|O6|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
419901|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419902|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419903|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419904|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419905|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419906|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419907|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419908|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419909|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419910|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419911|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419912|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419913|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419914|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419915|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419916|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419917|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419918|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419919|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419920|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419921|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419922|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419923|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
420213|NCT00564447|O5|Outcome|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
419924|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419925|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419926|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419927|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419928|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419929|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419930|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419931|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419932|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419933|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419934|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419935|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419936|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419937|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419938|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419939|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419940|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419941|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419942|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419943|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419944|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419945|NCT00565409|O1|Outcome|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419946|NCT00565409|O3|Outcome|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
420214|NCT00564447|O4|Outcome|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
419947|NCT00565409|O2|Outcome|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419948|NCT00565409|O1|Outcome|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) ≤ 3.2 at Week 36 and an average DAS28 ≤ from Week 12 visit through Week 36.
419949|NCT00565409|E4|Reported Event|Placebo Plus MTX-Period 2|Participants who were responders received matched placebo plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
419950|NCT00565409|E3|Reported Event|Etanercept 25 mg Plus MTX-Period 2|Participants who were responders received etanercept 25 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with DAS28 ≤ 3.2 at Week 36 and an average DAS28 ≤ 3.2 from Week 12 visit through Week 36.
419951|NCT00565409|E2|Reported Event|Etanercept 50 mg Plus MTX -Period 2|Participants who were responders received etanercept 50 mg SC injection plus oral MTX (15 to 25 mg) tablet once per week for 52 weeks. Responders defined as participants with a 28 Joint Disease Activity Score (DAS28) less than or equal to (≤) 3.2 at Week 36 and an average DAS28 less than or equal to (≤) 3.2 from Week 12 visit through Week 36.
419952|NCT00565409|E1|Reported Event|Etanercept 50 Milligrams (mg) Plus Methotrexate (MTX)-Period 1|Participants received etanercept (ETN) 50 mg subcutaneous (SC) injection plus oral MTX tablet 15 to 25 mg per week for 36 weeks.
419953|NCT00565370|B1|Baseline|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419954|NCT00565370|P1|Participant Flow|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib Level 1 sorafenib 400 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 2 sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 80 mg/m2 Level 3 sorafenib 800 mg/d, capecitabine 2,000 mg/m2/d, cisplatin 80 mg/m2 Level 1A sorafenib 800 mg/d, capecitabine 1,600 mg/m2/d, cisplatin 60 mg/m2
419955|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419956|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419957|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419958|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419959|NCT00565370|O1|Outcome|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419960|NCT00565370|E1|Reported Event|XP Plus Sorafenib|Capecitabine and cisplatin plus sorafenib
419961|NCT00565266|B1|Baseline|All Participants|All participants randomized into the six-sequence crossover study
419962|NCT00565266|P1|Participant Flow|All Participants|"All participants randomized into the six-sequence crossover study. All TALC participants underwent three 16-week treatment periods:~tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)~beclomethasone dipropionate 160 mcg twice daily (2xICS)"
419963|NCT00565266|O3|Outcome|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
419964|NCT00565266|O2|Outcome|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
419965|NCT00565266|O1|Outcome|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
419966|NCT00565266|E3|Reported Event|2xICS|beclomethasone dipropionate 160 mcg twice daily (2xICS)
419967|NCT00565266|E2|Reported Event|LABA + 1xICS|salmeterol xinafoate inhalation powder 50 mcg twice daily (LABA) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
419968|NCT00565266|E1|Reported Event|Tio + 1xICS|tiotropium bromide inhalation powder 18 mcg once daily (Tio) plus beclomethasone dipropionate 80 mcg twice daily (1xICS)
419969|NCT00565136|B1|Baseline|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419970|NCT00565136|P1|Participant Flow|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419971|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419972|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419973|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419974|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419975|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419976|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419977|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419978|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419979|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419980|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419981|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419982|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419983|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419984|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
420215|NCT00564447|O3|Outcome|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
419985|NCT00565136|O1|Outcome|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419986|NCT00565136|E1|Reported Event|TOPAS|"TOPAS AMS Pelvic Floor Repair System~TOPAS : A mesh sling permanently implanted to increase pelvic floor support"
419987|NCT00565084|B1|Baseline|Overall Study|
419988|NCT00565084|P3|Participant Flow|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
419989|NCT00565084|P2|Participant Flow|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
419990|NCT00565084|P1|Participant Flow|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
419991|NCT00565084|O3|Outcome|Placebo 2|Second Single dose placebo
419992|NCT00565084|O2|Outcome|Placebo 1|First Single dose placebo
419993|NCT00565084|O1|Outcome|Ibuprofen|Single dose ibuprofen 800 mg
419994|NCT00565084|E3|Reported Event|Ibuprofen-Placebo-Placebo|Single dose ibuprofen 800 mg; first single dose placebo; second single dose placebo
419995|NCT00565084|E2|Reported Event|Placebo-Ibuprofen-Placebo|First single dose placebo; single dose ibuprofen 800 mg; second single dose placebo
419996|NCT00565084|E1|Reported Event|Placebo-Placebo-Ibuprofen|First single dose placebo; second single dose placebo; single dose ibuprofen 800 mg
419997|NCT00565058|B3|Baseline|Total|Total of all reporting groups
419998|NCT00565058|B2|Baseline|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
419999|NCT00565058|B1|Baseline|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
420000|NCT00565058|P2|Participant Flow|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
420001|NCT00565058|P1|Participant Flow|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
420002|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
420003|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
420004|NCT00565058|O2|Outcome|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
420005|NCT00565058|O1|Outcome|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
420006|NCT00565058|E2|Reported Event|Phase II Arm|Phase II PD Study (Early GTI-2040) Group: In the Phase II PD Study Group, GTI-2040 is given 24 hours prior to addition of HiDAC.
420007|NCT00565058|E1|Reported Event|Pilot|Pilot PD Study (Delayed GTI-2040) Group: In the Pilot PD Study Group, addition of GTI-2040 is delayed until 24 hours after initiation of HiDAC.
420008|NCT00565045|B3|Baseline|Total|Total of all reporting groups
420009|NCT00565045|B2|Baseline|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420010|NCT00565045|B1|Baseline|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420011|NCT00565045|P2|Participant Flow|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420012|NCT00565045|P1|Participant Flow|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420013|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420014|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420015|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420039|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420040|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420016|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420017|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420018|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420019|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420020|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420021|NCT00565045|O2|Outcome|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420022|NCT00565045|O1|Outcome|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420023|NCT00565045|E2|Reported Event|cNMES|"cNMES - Cyclic NeuroMuscular Electrical Stimulation.~Preprogrammed cycles of finger and thumb flexor and extensor stimulation repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject.~Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation~Therapy sessions are done without the stimulation system"
420024|NCT00565045|E1|Reported Event|CCFES|"CCFES - Contralaterally Controlled Functional Electrical Stimulation~Stimulation to finger and thumb extensors and flexors only in response to and with an intensity proportional to opening and closing of the contralateral unimpaired hand~A glove instrumented with sensors and worn on the unimpaired hand detects the degree of hand opening and determines stimulation intensity~Therapy sessions are done with the subject being assisted by the CCFES system."
420025|NCT00564954|B3|Baseline|Total|Total of all reporting groups
420026|NCT00564954|B2|Baseline|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
420027|NCT00564954|B1|Baseline|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
420028|NCT00564954|P2|Participant Flow|Placebo Then Dex-methylphenidate Hydrochloride (Focalin XR)|Period 1: One week of placebo taken once daily in the morning followed by Period 2: one week of one 20 mg capsule of Focalin XR taken once daily in the morning.
420029|NCT00564954|P1|Participant Flow|Dex-methylphenidate Hydrochloride (Focalin XR) Then Placebo|Period 1: One 20 mg capsule of Focalin XR taken once daily in the morning for one week followed by Period 2: one week of placebo taken once daily in the morning.
420030|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420031|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420032|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420033|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420034|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420035|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420036|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420037|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420038|NCT00564954|O2|Outcome|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420141|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420041|NCT00564954|O1|Outcome|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420042|NCT00564954|E2|Reported Event|Placebo|Summary of the one week treatment on placebo once a day orally for 7 days for all 86 patients regardless of sequence.
420043|NCT00564954|E1|Reported Event|Dex-methylphenidate Hydrochloride (Focalin XR)|Summary of the one week treatment on dex-methylphenidate hydrochloride (Focalin XR), 20 mg capsule orally once a day, for all 86 patients regardless of sequence.
420044|NCT00564902|B4|Baseline|Total|Total of all reporting groups
420045|NCT00564902|B3|Baseline|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420046|NCT00564902|B2|Baseline|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420047|NCT00564902|B1|Baseline|Lutein|Lutein 9 mg per day
420048|NCT00564902|P3|Participant Flow|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420049|NCT00564902|P2|Participant Flow|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420050|NCT00564902|P1|Participant Flow|Lutein|Lutein 9 mg per day
420051|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420052|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420053|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420054|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420055|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420056|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420057|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420058|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420059|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420060|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420061|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420062|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420063|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420064|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420065|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420066|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420067|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420068|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420069|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420070|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420071|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420072|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420073|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420074|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420075|NCT00564902|O3|Outcome|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420076|NCT00564902|O2|Outcome|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420077|NCT00564902|O1|Outcome|Lutein|Lutein 9 mg per day
420078|NCT00564902|E3|Reported Event|Zeaxanthin|3R 3'R Zeaxanthin 8 mg per day during 12 months
420079|NCT00564902|E2|Reported Event|Lutein Zeaxanthin|3R 3'R Zeaxanthin 8 mg, Lutein 8 mg per day during 12 months
420080|NCT00564902|E1|Reported Event|Lutein|Lutein 9 mg per day
420081|NCT00564889|B1|Baseline|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420082|NCT00564889|P1|Participant Flow|Len/Cyc/Dex|"Lenalidomide (Len) 15mg daily (days 1-21)~Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15)~Dexamethasone (Dex) 40 mg weekly"
420083|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420084|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420085|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420086|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420087|NCT00564889|O1|Outcome|Len/Cyc/Dex|Lenalidomide (Len) 15mg daily (days 1-21); Cyclophosphamide (Cyc) 300 mg/m^2 (days 1, 8, 15); Dexamethasone (Dex) 40 mg weekly
420088|NCT00564889|E1|Reported Event|Len/Cyc/Dex|Dexamethasone (Dex) 40 mg weekly
420089|NCT00564876|B1|Baseline|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420090|NCT00564876|P1|Participant Flow|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420142|NCT00564681|E4|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
424902|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
420091|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420092|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420093|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420094|NCT00564876|O1|Outcome|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420095|NCT00564876|E1|Reported Event|Neoadjuvant Dasatinib|Neoadjuvant dasatinib is to be administered as an oral dose of 70 mg PO twice daily on a continuous basis for 3 weeks prior to surgery. Patients will begin adjuvant dasatinib (70 mg PO twice daily) between 4-6 weeks after standard adjuvant therapy is complete or 4-8 weeks after surgery for those patients that do not receive adjuvant chemotherapy. Adjuvant dasatinib will be given on a continuous basis for up to 3 months after adjuvant chemotherapy or after surgery if no adjuvant chemotherapy is given.
420096|NCT00564850|B1|Baseline|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420097|NCT00564850|P1|Participant Flow|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420098|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420099|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420100|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420101|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420102|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420103|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420104|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420105|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420106|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420107|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420108|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420109|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420110|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420111|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420112|NCT00564850|O1|Outcome|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420113|NCT00564850|E1|Reported Event|Triptorelin Pamoate 11.25 mg|11.25 mg triptorelin pamoate via intramuscular injection at baseline and month 3.
420114|NCT00564733|B1|Baseline|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
420143|NCT00564681|E3|Reported Event|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
420144|NCT00564681|E2|Reported Event|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420145|NCT00564681|E1|Reported Event|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420146|NCT00564629|B3|Baseline|Total|Total of all reporting groups
420216|NCT00564447|O2|Outcome|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
420115|NCT00564733|P1|Participant Flow|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
420116|NCT00564733|O1|Outcome|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
420117|NCT00564733|E1|Reported Event|Chemotherapy|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients undergo FDG PET/CT scan between days 18-21. Patients that are responding to treatment receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for up to 3 additional courses in the absence of disease progression or unacceptable toxicity.Patients then receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and docetaxel IV over 1 hour on day 8. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients undergo FDG PET/CT scan between days 18-21 of course 2.~carboplatin: Given IV~docetaxel: Given IV~gemcitabine hydrochloride: Given IV~paclitaxel: Given IV~computed tomography: Undergo FDG PET/CT~positron emission tomography: Undergo FDG PET/CT~fludeoxyglucose F 18: Given IV~imaging biomarker analysis: Correlative studies"
420118|NCT00564681|B5|Baseline|Total|Total of all reporting groups
420119|NCT00564681|B4|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
420120|NCT00564681|B3|Baseline|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
420121|NCT00564681|B2|Baseline|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420122|NCT00564681|B1|Baseline|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420123|NCT00564681|P4|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A Formulation 2|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A Formulation 2 for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
420124|NCT00564681|P3|Participant Flow|Placebo (Normal Saline) / Botulinum Toxin Type A|Intramuscular injections of the assigned study medication into the affected muscles (placebo for treatment cycle 1 and botulinum toxin Type A for subsequent treatments). Maximum dose of 360 units. Subjects may receive up to three treatments.
420125|NCT00564681|P2|Participant Flow|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420126|NCT00564681|P1|Participant Flow|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units. Subjects may receive up to three treatments.
420127|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
420128|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420129|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420130|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
420131|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420132|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420133|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
420134|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420135|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420136|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
420137|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420138|NCT00564681|O1|Outcome|Botulinum Toxin Type A|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420139|NCT00564681|O3|Outcome|Placebo (Normal Saline)|Intramuscular injections into the affected muscles. Includes all patients who received placebo in Cycle 1.
420140|NCT00564681|O2|Outcome|Botulinum Toxin Type A Formulation 2|Intramuscular injections into the affected muscles. Maximum dose of 360 units.
420207|NCT00564447|P3|Participant Flow|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
420147|NCT00564629|B2|Baseline|IV APAP 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g of acetaminophen in 100 ml of intravenous solution and oral placebo as the study treatment
420148|NCT00564629|B1|Baseline|PO APAP 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen and 100 ml of intravenous placebo solution as the study treatment
420149|NCT00564629|P2|Participant Flow|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
420150|NCT00564629|P1|Participant Flow|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
420151|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420152|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420153|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420154|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420155|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420156|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420157|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420158|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420159|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420160|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420161|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420162|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420163|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420164|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420165|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420166|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420167|NCT00564629|O2|Outcome|PO APAP 1 g|mITT-Oral Acetaminophen 1 g
420168|NCT00564629|O1|Outcome|IV APAP 1 g / 100 ml Solution|mITT-Intravenous Acetaminophen 1g
420169|NCT00564629|E2|Reported Event|Intravenous Acetaminophen (IV APAP) 1 g / 100 ml Solution|group of subjects randomly selected to receive 1 g /100 ml of intravenous acetaminophen solution as the study treatment
420170|NCT00564629|E1|Reported Event|Oral Acetaminophen (PO APAP) 1 g|group of subjects randomly selected to receive 1 g of oral acetaminophen as the study treatment
420171|NCT00564486|B4|Baseline|Total|Total of all reporting groups
420172|NCT00564486|B3|Baseline|IV Acetaminophen 650 mg|All subjects randomized to receive IV Acetaminophen 650 mg
420173|NCT00564486|B2|Baseline|IV Acetaminophen 1 gm|All subjects randomized to receive IV Acetaminophen 1 gm
420174|NCT00564486|B1|Baseline|IV Placebo|All subjects randomized to receive IV Placebo 100 ml and IV placebo 65 ml groups combined
420175|NCT00564486|P4|Participant Flow|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
420176|NCT00564486|P3|Participant Flow|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
420177|NCT00564486|P2|Participant Flow|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
420178|NCT00564486|P1|Participant Flow|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
420179|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours (6 doses total)
420180|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm every 6 hours for 24 hours (4 doses total)
420181|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
420182|NCT00564486|O3|Outcome|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg every 4 hours for 24 hours
420183|NCT00564486|O2|Outcome|IV Acetaminophen 1000 mg|IV Acetaminophen 1000 mg every 6 hours for 24 hours
420184|NCT00564486|O1|Outcome|IV Placebo|IV Placebo 100 ml and IV placebo 65 ml groups combined
420185|NCT00564486|O2|Outcome|IV Acetaminophen 650 mg|mITT - IV Acetaminophen 650 mg
420186|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
420187|NCT00564486|O2|Outcome|IV Acetaminophen 1 gm|mITT - IV Acetaminophen 1 gm
420188|NCT00564486|O1|Outcome|IV Placebo|mITT - IV Placebo 100 ml and IV placebo 65 ml groups combined
420189|NCT00564486|E4|Reported Event|IV Placebo (65 ml)|IV Placebo 65 ml dosed every every 4 hours for 24 hours (6 doses total).
420190|NCT00564486|E3|Reported Event|IV Acetaminophen 650 mg|IV Acetaminophen 650 mg dosed every every 4 hours for 24 hours (6 doses total).
420191|NCT00564486|E2|Reported Event|IV Acetaminophen 1 gm|IV Acetaminophen 1 gm dosed every every 6 hours for 24 hours (4 doses total).
420192|NCT00564486|E1|Reported Event|Intravenous (IV) Placebo (100 ml)|IV Placebo 100 ml dosed every every 6 hours for 24 hours (4 doses total).
420193|NCT00564447|B9|Baseline|Total|Total of all reporting groups
420194|NCT00564447|B8|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
420195|NCT00564447|B7|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
420196|NCT00564447|B6|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
420197|NCT00564447|B5|Baseline|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
420198|NCT00564447|B4|Baseline|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
420199|NCT00564447|B3|Baseline|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
420200|NCT00564447|B2|Baseline|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
420201|NCT00564447|B1|Baseline|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
420202|NCT00564447|P8|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
420203|NCT00564447|P7|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
420204|NCT00564447|P6|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
420205|NCT00564447|P5|Participant Flow|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
420206|NCT00564447|P4|Participant Flow|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
420217|NCT00564447|O1|Outcome|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
420218|NCT00564447|E8|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-24 Hours Post Dose|
420219|NCT00564447|E7|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-12 Hours Post Dose|
420220|NCT00564447|E6|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-2 Hours Post Dose|
420221|NCT00564447|E5|Reported Event|Moxifloxacin 0.5% Ophthalmic Solution-30 Minutes Post Dose|
420222|NCT00564447|E4|Reported Event|Azithromycin Ophthalmic Solution, 1% -24 Hours Post Dose|
420223|NCT00564447|E3|Reported Event|Azithromycin Ophthalmic Solution, 1% -12 Hours Post Dose|
420224|NCT00564447|E2|Reported Event|Azithromycin Ophthalmic Solution, 1% -2 Hours Post Dose|
420225|NCT00564447|E1|Reported Event|Azithromycin Ophthalmic Solution, 1% -30 Minutes Post Dose|
420226|NCT00564278|B3|Baseline|Total|Total of all reporting groups
420227|NCT00564278|B2|Baseline|Motivational Pharmacotherapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 44.1 with SD=12.3.
420228|NCT00564278|B1|Baseline|Standard Medication Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater. Mean age was 43.4 with SD=13.2.
420229|NCT00564278|P2|Participant Flow|Motivational Antidepressant Therapy|As per study criteria, the N=98 sample is our sample for data analysis. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 44.1 (SD = 12.3).
420230|NCT00564278|P1|Participant Flow|Standard Antidepressant Therapy|As per study criteria, the N=97 sample is our sample for data analysis. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline Hamilton Depression Scale-17 score of 16 or greater. Mean age was 43.41 (SD = 13.2).
420231|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420232|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420233|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420234|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420235|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420236|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420237|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420238|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420239|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420240|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420241|NCT00564278|O2|Outcome|Motivational Antidepressant Therapy|N=98 patients were enrolled in this study arm and participated in at least one medication visit. There were 36 men and 62 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420242|NCT00564278|O1|Outcome|Standard Antidepressant Therapy|N=97 patients were enrolled in this study arm and participated in at least one medication visit. There were 37 men and 60 women. All were of Hispanic ethnicity, as the study focused on this population exclusively. All were depressed, with a baseline HAMD-17 score of 16 or greater.
420243|NCT00564278|E2|Reported Event|Motivational Antidepressant Therapy|Participants will receive motivational antidepressant therapy. Motivational antidepressant therapy (MADT): The same medication treatment for depression will be offered as in the SADT arm and supplemented with techniques from motivational interviewing.
420336|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
424903|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
420244|NCT00564278|E1|Reported Event|Standard Antidepressant Therapy|Participants will receive standard antidepressant therapy. Standard antidepressant therapy (SADT): Treatment with medication will follow the Texas Medication Algorithm (TMA) for Depression. Antidepressant medications may include the following: citalopram (Celexa), escitalopram (Lexapro), paroxetine (Paxil CR), sertraline (Zoloft), venlafaxine XR (Effexor XR), bupropion SR (Wellbutrin SR), duloxetine (Cymbalta), nortriptyline (Pamelor), and mirtazapine (Remeron).
420245|NCT00564265|B1|Baseline|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
420246|NCT00564265|P1|Participant Flow|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
420247|NCT00564265|O1|Outcome|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
420248|NCT00564265|E1|Reported Event|Gastrointestinal Stromal Tumor (GIST)|GIST in all locations: Stomach, duodenum, jejunum, ileum, and rectum. All patients were submitted to surgery and in 2 cases are on Imatinib therapy.
420249|NCT00563797|B3|Baseline|Total|Total of all reporting groups
420250|NCT00563797|B2|Baseline|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420251|NCT00563797|B1|Baseline|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420252|NCT00563797|P2|Participant Flow|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420253|NCT00563797|P1|Participant Flow|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420254|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420255|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420256|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420257|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420258|NCT00563797|O2|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420259|NCT00563797|O1|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420260|NCT00563797|O2|Outcome|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420261|NCT00563797|O1|Outcome|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to the medication capsules.~Placebo: Placebo pill"
420262|NCT00563797|E2|Reported Event|Placebo|"Placebo capsules were prepared by the pharmacy and were identical in size and color to themedication capsules.~Placebo: Placebo pill"
420263|NCT00563797|E1|Reported Event|Mecamylamine|"Mecamylamine is a noncompetitive, high-affinity nAChR antagonist with low selectivity for the alpha-7 receptor. Those receiving mecamylamine started at 2.5mg once daily (second dose was placebo). The dose was increased to 5.0 mg twice daily over 3 weeks.~Mecamylamine: mecamylamine 10mg/day for 12 weeks"
420264|NCT00563706|B10|Baseline|Total|Total of all reporting groups
420265|NCT00563706|B9|Baseline|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420266|NCT00563706|B8|Baseline|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420267|NCT00563706|B7|Baseline|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420268|NCT00563706|B6|Baseline|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420395|NCT00563381|B3|Baseline|Total|Total of all reporting groups
420269|NCT00563706|B5|Baseline|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420270|NCT00563706|B4|Baseline|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420271|NCT00563706|B3|Baseline|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420272|NCT00563706|B2|Baseline|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420273|NCT00563706|B1|Baseline|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420274|NCT00563706|P9|Participant Flow|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420275|NCT00563706|P8|Participant Flow|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420276|NCT00563706|P7|Participant Flow|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420277|NCT00563706|P6|Participant Flow|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420278|NCT00563706|P5|Participant Flow|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420279|NCT00563706|P4|Participant Flow|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420280|NCT00563706|P3|Participant Flow|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420281|NCT00563706|P2|Participant Flow|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420282|NCT00563706|P1|Participant Flow|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420283|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420284|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420285|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420286|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420287|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420288|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420289|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420290|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420291|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420292|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420293|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420294|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420295|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420296|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420297|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420298|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420299|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420300|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420301|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420302|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420303|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420304|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420305|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420306|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420307|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420308|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420309|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420310|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420311|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420312|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420313|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420314|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420315|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420316|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420317|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420318|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420319|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420320|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420321|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420322|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420323|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420324|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420325|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420326|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420327|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420328|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420329|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420330|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420331|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420332|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420333|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420334|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420335|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420396|NCT00563381|B2|Baseline|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420337|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420338|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420339|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420340|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420341|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420342|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420343|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420344|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420345|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420346|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420347|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420348|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420349|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420350|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420351|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420352|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420496|NCT00563368|E4|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
420353|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420354|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420355|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420356|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420357|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420358|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420359|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420360|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420361|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420362|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420363|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420364|NCT00563706|O9|Outcome|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420365|NCT00563706|O8|Outcome|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420366|NCT00563706|O7|Outcome|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420367|NCT00563706|O6|Outcome|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420368|NCT00563706|O5|Outcome|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420397|NCT00563381|B1|Baseline|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420497|NCT00563368|E3|Reported Event|TPM 46 mg|46 mg topiramate
420498|NCT00563368|E2|Reported Event|PHEN 7.5 mg|7.5 mg phentermine
420369|NCT00563706|O4|Outcome|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420370|NCT00563706|O3|Outcome|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420371|NCT00563706|O2|Outcome|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420372|NCT00563706|O1|Outcome|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420373|NCT00563706|E9|Reported Event|Risperidone|One risperidone 4 mg capsule and 3 placebo capsules matched to risperidone (equivalent to risperidone 4 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 risperidone 2 mg capsule and 1 placebo capsule matched to risperidone (equivalent to risperidone 2 mg) orally once daily up to Day 35 during taper phase.
420374|NCT00563706|E8|Reported Event|Vabicaserin 600 mg|Three vabicaserin 200 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 600 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420375|NCT00563706|E7|Reported Event|Vabicaserin 400 mg|Two vabicaserin 200 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 400 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 200 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 32 and then 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 35 during taper phase.
420376|NCT00563706|E6|Reported Event|Vabicaserin 300 mg|Three vabicaserin 100 mg capsules and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 300 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420377|NCT00563706|E5|Reported Event|Vabicaserin 200 mg|Two vabicaserin 100 mg capsules and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 200 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 100 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 32 and then 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 35 during taper phase.
420378|NCT00563706|E4|Reported Event|Vabicaserin 150 mg|One vabicaserin 50 mg capsule, 1 vabicaserin 100 mg capsule, and 2 placebo capsules matched to vabicaserin (equivalent to vabicaserin 150 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 1 vabicaserin 50 mg capsule and 1 placebo capsule matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 32 and then 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420379|NCT00563706|E3|Reported Event|Vabicaserin 100 mg|One vabicaserin 100 mg capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 100 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420380|NCT00563706|E2|Reported Event|Vabicaserin 50 mg|One vabicaserin 50 milligram (mg) capsule and 3 placebo capsules matched to vabicaserin (equivalent to vabicaserin 50 mg) orally once daily up to Day 28 during double-blind treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420381|NCT00563706|E1|Reported Event|Placebo|Four placebo capsules matched to vabicaserin (SCA-136) orally once daily up to Day 28 during double-blind (DB) treatment phase followed by 2 placebo capsules matched to vabicaserin orally once daily up to Day 35 during taper phase.
420382|NCT00563576|B3|Baseline|Total|Total of all reporting groups
420383|NCT00563576|B2|Baseline|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420384|NCT00563576|B1|Baseline|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420385|NCT00563576|P2|Participant Flow|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420386|NCT00563576|P1|Participant Flow|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420387|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420388|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420389|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420390|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420391|NCT00563576|O2|Outcome|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420392|NCT00563576|O1|Outcome|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420393|NCT00563576|E2|Reported Event|Depot Medroxyprogesterone Acetate (DMPA) Alone|Subjects will receive Depo-Provera intramuscular injection.
420394|NCT00563576|E1|Reported Event|Femring|Subjects will receive an estrogen vaginal ring (100mcg) during the first 90 days of Depo-Provera use.
420398|NCT00563381|P2|Participant Flow|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420399|NCT00563381|P1|Participant Flow|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420400|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420401|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420402|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420403|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420404|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420405|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420406|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420407|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420408|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420409|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420410|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420411|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420412|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420413|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420414|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420415|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420416|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420417|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420418|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420419|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420420|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420421|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420422|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420423|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420424|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420425|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420426|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420427|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420428|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420429|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420430|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420431|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420432|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420433|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420434|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420435|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420436|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420492|NCT00563368|O1|Outcome|Placebo|Placebo
420493|NCT00563368|E7|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
420437|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420438|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420439|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420440|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420441|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420442|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420443|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420444|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420445|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420446|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420447|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420448|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420449|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420450|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420451|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420452|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420453|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420454|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420455|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420456|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420457|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420458|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420459|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420460|NCT00563381|O2|Outcome|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420461|NCT00563381|O1|Outcome|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420462|NCT00563381|E2|Reported Event|Salmeterol|Salmeterol 50 mcg (2 actuations of 25 mcg) twice daily inhalation (suspension) via MDI and Placebo HandiHaler® once daily
420463|NCT00563381|E1|Reported Event|Tiotropium|Tiotropium 18 mcg once daily (QD) inhalation (powder) via HandiHaler® and matching Placebo metered dose inhaler (MDI) twice daily (BID)
420464|NCT00563368|B8|Baseline|Total|Total of all reporting groups
420465|NCT00563368|B7|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
420466|NCT00563368|B6|Baseline|TPM 92 mg|92 mg topiramate
420467|NCT00563368|B5|Baseline|PHEN 15 mg|15 mg phentermine
420468|NCT00563368|B4|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
420469|NCT00563368|B3|Baseline|TPM 46 mg|46 mg topiramate
420470|NCT00563368|B2|Baseline|PHEN 7.5 mg|7.5 mg phentermine
420471|NCT00563368|B1|Baseline|Placebo|Placebo
420472|NCT00563368|P7|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
420473|NCT00563368|P6|Participant Flow|TPM 92 mg|92 mg topiramate
420474|NCT00563368|P5|Participant Flow|PHEN 15 mg|15 mg phentermine
420475|NCT00563368|P4|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
420476|NCT00563368|P3|Participant Flow|TPM 46 mg|46 mg topiramate
420477|NCT00563368|P2|Participant Flow|PHEN 7.5 mg|7.5 mg phentermine
420478|NCT00563368|P1|Participant Flow|Placebo|Placebo
420479|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
420480|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
420481|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
420482|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
420483|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
420484|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
420485|NCT00563368|O1|Outcome|Placebo|Placebo
420486|NCT00563368|O7|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
420487|NCT00563368|O6|Outcome|TPM 92 mg|92 mg topiramate
420488|NCT00563368|O5|Outcome|PHEN 15 mg|15 mg phentermine
420489|NCT00563368|O4|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
420490|NCT00563368|O3|Outcome|TPM 46 mg|46 mg topiramate
420491|NCT00563368|O2|Outcome|PHEN 7.5 mg|7.5 mg phentermine
420500|NCT00563316|B1|Baseline|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420501|NCT00563316|P1|Participant Flow|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420502|NCT00563316|O5|Outcome|Treatment Phase 4|All Other – 72 hours after administration of irinotecan in Cycle 2 until end of study.
420503|NCT00563316|O4|Outcome|Treatment Phase 3|Cycle 2 Irinotecan and Panitumumab – After irinotecan administration until 72 hours after administration.
420504|NCT00563316|O3|Outcome|Treatment Phase 2|Cycle 1 Irinotecan and Panitumumab – After first panitumumab administration until the start of Cycle 2.
420505|NCT00563316|O2|Outcome|Treatment Phase 1|Cycle 1 Irinotecan – After irinotecan administration, but before panitumumab administration.
420506|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420507|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420508|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420509|NCT00563316|O1|Outcome|Panitumumab + Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420510|NCT00563316|E1|Reported Event|Panitumumab With Irinotecan|Participants received panitumumab 6 mg/kg and irinotecan 180 mg/m² administered by intravenous (IV) infusion every 2 weeks until disease progression or intolerance of panitumumab, irinotecan or both.
420511|NCT00563290|B3|Baseline|Total|Total of all reporting groups
420512|NCT00563290|B2|Baseline|Arm II Dastinib|Patients receive oral dasatinib 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
420513|NCT00563290|B1|Baseline|Arm I Dasatinib|Patients receive oral dasatinib 100 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
420514|NCT00563290|P2|Participant Flow|Arm II Dasatinib|Patients receive 70 mg dasatinib PO BID on days 1-28
420515|NCT00563290|P1|Participant Flow|Arm I Dasatinib|Patients receive 100 mg orally twice a day.
420516|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
420517|NCT00563290|O1|Outcome|Dasatinib|Patients receive 100 mg orally twice a day. Due to a dosing update the dose was decreased to 70 mg orally twice a day.
420518|NCT00563290|O1|Outcome|Arm I and Arm II|"For Arm I patients receive Dasatinib100 mg orally twice a day.~For Arm II patients receive Dasatinib 70 mg orally twice a day."
420519|NCT00563290|O2|Outcome|Arm II: Dasatinib|Patients receive 70 mg orally twice a day.
420520|NCT00563290|O1|Outcome|Arm I: Dasatinib|Patients receive 100 mg orally twice a day.
420521|NCT00563290|E2|Reported Event|Dasatinib 70 mg|Patients receive the initial dose of 70 mg orally twice a day. Dose was reduced to 70 mg orally based on toxicity.
420522|NCT00563290|E1|Reported Event|Dasatinib 100 mg|Patients receive the initial dose of 100 mg orally twice a day.
420523|NCT00562861|B3|Baseline|Total|Total of all reporting groups
420524|NCT00562861|B2|Baseline|Mood Stabilizer Plus Placebo|Placebo plus mood stabilizer: subjects receive placebo, added to standard mood stabilizers
420525|NCT00562861|B1|Baseline|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Subjects receive the active drug, added to standard mood stabilizers.
420526|NCT00562861|P2|Participant Flow|Mood Stabilizer Plus Placebo|Mood stabilizer alone will be the treatment, with placebo used instead of double-blind citalopram.
420527|NCT00562861|P1|Participant Flow|Mood Stabilizer Plus Citalopram|citalopram + mood stabilizer: Citalopram dose will be flexibly designed, beginning at 10 mg/d for at least one week, and the increased by 10 mg per week to a maximum of 50 mg/d.
420528|NCT00562861|O2|Outcome|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
420529|NCT00562861|O1|Outcome|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
420530|NCT00562861|E2|Reported Event|Placebo|Mood stabilizers given as part of standard treatment plus double-blind placebo
420531|NCT00562861|E1|Reported Event|Citalopram|Mood stabilizers given as part of standard treatment plus double-blind citalopram
420532|NCT00562627|B4|Baseline|Total|Total of all reporting groups
420533|NCT00562627|B3|Baseline|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420534|NCT00562627|B2|Baseline|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
420535|NCT00562627|B1|Baseline|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420536|NCT00562627|P3|Participant Flow|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420537|NCT00562627|P2|Participant Flow|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
420538|NCT00562627|P1|Participant Flow|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420539|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420540|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
421036|NCT00561652|P2|Participant Flow|Arm 2|Chiropractic treatment plus education plus exercise
420541|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420542|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420543|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
420544|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420545|NCT00562627|O3|Outcome|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420546|NCT00562627|O2|Outcome|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
420547|NCT00562627|O1|Outcome|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420548|NCT00562627|E3|Reported Event|Epidural|continuous epidural analgesia with fentanyl 2 ug/ml, bupivacaine 1mg/ml and epinephrine 1 ug/ml
420549|NCT00562627|E2|Reported Event|LIA IA, (Local Infiltration Analgesia, Intra-articular)|Local infiltration analgesia with 150 mg ropivacaine, 0.5 mg adrenaline and 30 mg ketorolac and 5 mg morphine
420550|NCT00562627|E1|Reported Event|LIA IV (Local Infiltration Analgesia, Intravenous)|Local infiltration analgesia with 150 mg ropivacaine and 0.5 mg adrenaline and intravenous 30 mg ketorolac and 5mg morphine
420551|NCT00562588|B3|Baseline|Total|Total of all reporting groups
420552|NCT00562588|B2|Baseline|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420553|NCT00562588|B1|Baseline|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420554|NCT00562588|P2|Participant Flow|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420555|NCT00562588|P1|Participant Flow|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420556|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420557|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420558|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420559|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420560|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420561|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420562|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420563|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420564|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420565|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420566|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420567|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420568|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420569|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420570|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420571|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420572|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420573|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420574|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420575|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420576|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420577|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420578|NCT00562588|O2|Outcome|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420579|NCT00562588|O1|Outcome|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420580|NCT00562588|E2|Reported Event|Aggrenox|Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420581|NCT00562588|E1|Reported Event|Aspirin for 7 Days, Followed by Aggrenox|ASA 100 mg qd for 7 days, followed by Aggrenox (dipyridamole 200mg + ASA 25mg) b.i.d
420582|NCT00562484|B3|Baseline|Total|Total of all reporting groups
420583|NCT00562484|B2|Baseline|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420584|NCT00562484|B1|Baseline|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420585|NCT00562484|P2|Participant Flow|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420586|NCT00562484|P1|Participant Flow|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420587|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420588|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420589|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
421037|NCT00561652|P1|Participant Flow|Arm 1|Education plus exercise
420590|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420591|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420592|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420593|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420594|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420595|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420596|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420597|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420598|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420599|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420600|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420601|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420602|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420603|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420604|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420605|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420606|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420607|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420608|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420609|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420610|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420611|NCT00562484|O2|Outcome|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420612|NCT00562484|O1|Outcome|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420613|NCT00562484|E2|Reported Event|Placebo|Participants received a dose of placebo in either 2008 or 2009 Southern Hemisphere influenza season
420614|NCT00562484|E1|Reported Event|CSL's IVV|Participants received a dose of the 2008 or 2009 Southern Hemisphere formulation of CSL's IVV
420615|NCT00562354|B3|Baseline|Total|Total of all reporting groups
420616|NCT00562354|B2|Baseline|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420617|NCT00562354|B1|Baseline|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420618|NCT00562354|P2|Participant Flow|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420619|NCT00562354|P1|Participant Flow|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420620|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420621|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
420622|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420623|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420624|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age.
420625|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420626|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420627|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420628|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420629|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420630|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420631|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420632|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420633|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420837|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420634|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420635|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420636|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420637|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420638|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420639|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420640|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420641|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420642|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420643|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420644|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420645|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420646|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420647|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420648|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420649|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420650|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420651|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420652|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420653|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420654|NCT00562354|O2|Outcome|13vPnC (≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.
420655|NCT00562354|O1|Outcome|13vPnC (50 to 64 Years of Age)|13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.
420656|NCT00562354|O1|Outcome|13vPnC Overall Population (50 to 64 and ≥65 Years of Age)|13vPnC administered as a single dose of 0.5 mL IM to participants 50 to 64 years of age and ≥65 years of age.
420657|NCT00562354|E2|Reported Event|13vPnC (≥65 Years of Age)|"13vPnC administered as a single dose of 0.5 mL IM to participants ≥65 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=77; systematic (solicited) Local Reactions N=118; systematic (solicited) Systemic Events N=116. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
420658|NCT00562354|E1|Reported Event|13vPnC (50 to 64 Years of Age)|"13-valent pneumococcal conjugate vaccine (13vPnC) administered as a single dose of 0.5 milliliters (mL) intramuscularly (IM) to participants 50 to 64 years of age.~For Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=80; systematic (solicited) Local Reactions N=120; systematic (solicited) Systemic Events N=112. Serious AEs were grouped by organ system, with frequency of events summarized. Non-serious AEs were summarized in a similar manner and include unsolicited AEs collected in the e-diary (systematic assessment) and solicited events collected on the case report form (non-systematic methods)."
420659|NCT00562328|B1|Baseline|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
420660|NCT00562328|P1|Participant Flow|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
420661|NCT00562328|O1|Outcome|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
420662|NCT00562328|E1|Reported Event|Alemtuzumab + Rituximab + GM-CSF|Alemtuzumab + Rituximab + GM-CSF
420663|NCT00562315|B1|Baseline|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420664|NCT00562315|P1|Participant Flow|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420665|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420666|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420667|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420668|NCT00562315|O1|Outcome|FACBC PET/CT for Recurrent Prostate Cancer|"This is a single arm study~[18F]FACBC: [18F]FACBC is given intravenously prior to PET scan"
420669|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420670|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420671|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420672|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420673|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420674|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420675|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420676|NCT00562315|O1|Outcome|FACBC PET-CT and ProstaScint CT|Participants diagnosed with localized prostate carcinoma with subsequent definitive therapy or suspicion of recurrent cancer underwent an FACBC PET-CT scan and the ProstaScinct CT.
420677|NCT00562315|E1|Reported Event|FACBC PET-CT and ProstaScint CT|All participants who received scans, including repeat scans, were monitored for adverse events.
420678|NCT00562302|B3|Baseline|Total|Total of all reporting groups
420679|NCT00562302|B2|Baseline|Control Group|Control group with no intervention
420680|NCT00562302|B1|Baseline|Bio-Seal Group|Bio-Seal Plug Implanted
420681|NCT00562302|P2|Participant Flow|Control Group|Control group with no intervention
420682|NCT00562302|P1|Participant Flow|Bio-Seal Group|Bio-Seal Plug Implanted
420683|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420684|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420685|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420686|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420687|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420688|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420689|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420690|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420691|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420692|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420693|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420694|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420695|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420696|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420697|NCT00562302|O2|Outcome|Control Group|Control group with no intervention
420698|NCT00562302|O1|Outcome|Bio-Seal Group|Bio-Seal Plug Implanted
420699|NCT00562302|E2|Reported Event|Control Group|Control group with no intervention
420700|NCT00562302|E1|Reported Event|Bio-Seal Group|Bio-Seal Plug Implanted
420701|NCT00562159|B3|Baseline|Total|Total of all reporting groups
420702|NCT00562159|B2|Baseline|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
420703|NCT00562159|B1|Baseline|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420704|NCT00562159|P2|Participant Flow|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
420705|NCT00562159|P1|Participant Flow|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420706|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
420707|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420708|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
420709|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420710|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
420711|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420712|NCT00562159|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
420713|NCT00562159|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420714|NCT00562159|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablets administered sublingually once daily.
420715|NCT00562159|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
420716|NCT00562120|B1|Baseline|Entire Study Population|All participants randomized to any treatment (PF-03654746 10 mg capsule first, PF-03654746 1 mg capsule first, Allegra-D tablet-in-capsule first and placebo first).
420739|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
424904|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
420717|NCT00562120|P4|Participant Flow|Placebo, Allegra-D, PF-03654746 10 mg, PF-03654746 1 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
420718|NCT00562120|P3|Participant Flow|Allegra-D, PF-03654746 1 mg, Placebo, PF-03654746 10 mg|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
420719|NCT00562120|P2|Participant Flow|PF-03654746 1 mg, PF-03654746 10 mg, Allegra-D, Placebo|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the first intervention period; followed by PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule and Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
420720|NCT00562120|P1|Participant Flow|PF-03654746 10 mg, Placebo, PF-03654746 1 mg, Allegra-D|PF-03654746 10 milligram (mg) capsule and Allegra (fexofenadine 60 mg) tablet-in-capsule along with placebo matched to Allegra-D (fexofenadine 60 mg in combination with pseudoephedrine 120 mg) tablet-in-capsule on Day 1 in the first intervention period; followed by placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the second intervention period; then PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 in the third intervention period; and placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 in the fourth intervention period. A washout period of at least 14 days was maintained between each treatment period.
420721|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420722|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420723|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420724|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420725|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420726|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420727|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420728|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420729|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420730|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420731|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420732|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420733|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420734|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420735|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420736|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420737|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420738|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420740|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420741|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420742|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420743|NCT00562120|O4|Outcome|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420744|NCT00562120|O3|Outcome|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420745|NCT00562120|O2|Outcome|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420746|NCT00562120|O1|Outcome|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420747|NCT00562120|E4|Reported Event|Placebo|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420748|NCT00562120|E3|Reported Event|Allegra-D|Placebo matched to PF-03654746 capsule and placebo matched to Allegra tablet-in-capsule along with Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420749|NCT00562120|E2|Reported Event|PF-03654746 1 mg|PF-03654746 1 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420750|NCT00562120|E1|Reported Event|PF-03654746 10 mg|PF-03654746 10 mg capsule and Allegra tablet-in-capsule along with placebo matched to Allegra-D tablet-in-capsule on Day 1 of any of the intervention periods.
420751|NCT00562094|B1|Baseline|Pantoprazole|All patients enrolled
420752|NCT00562094|P1|Participant Flow|Pantoprazole|All patients enrolled
420753|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
420754|NCT00562094|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
420755|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
420756|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
420757|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
420758|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
420759|NCT00562094|O1|Outcome|Pantoprazole|All patients with valid values ('as observed')
420760|NCT00562094|O2|Outcome|Pantoprazole / End of Therapy|All patients with valid values ('as observed')
420761|NCT00562094|O1|Outcome|Pantoprazole / Start of Therapy|All patients with valid values ('as observed')
420762|NCT00562094|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
420763|NCT00561977|B4|Baseline|Total|Total of all reporting groups
420764|NCT00561977|B3|Baseline|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420765|NCT00561977|B2|Baseline|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420766|NCT00561977|B1|Baseline|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420767|NCT00561977|P3|Participant Flow|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420768|NCT00561977|P2|Participant Flow|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420769|NCT00561977|P1|Participant Flow|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420770|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420771|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420772|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420773|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420774|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420775|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420776|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420777|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420778|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420779|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420780|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420781|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420782|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420783|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420784|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420785|NCT00561977|O3|Outcome|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420786|NCT00561977|O2|Outcome|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420787|NCT00561977|O1|Outcome|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420788|NCT00561977|E3|Reported Event|Combination Diet|Combination low saturated fat (≤7% of total calories);high fiber (>30g fiber per day) -500 kcal from RMR, not less than 1200 kcal/day.
420789|NCT00561977|E2|Reported Event|Low Saturated Fat|low saturated fat diet (≤7% of total calories); -500 calories from RMR, not less than 1200 kcal per day.
420790|NCT00561977|E1|Reported Event|High Fiber Diet|high fiber diet (≥30 grams of total fiber per day); reduction of calories to -500 from resting metabolic rate (RMR), not less than 1200 kcal per day.
420791|NCT00561951|B4|Baseline|Total|Total of all reporting groups
420792|NCT00561951|B3|Baseline|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420793|NCT00561951|B2|Baseline|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420794|NCT00561951|B1|Baseline|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420795|NCT00561951|P3|Participant Flow|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420796|NCT00561951|P2|Participant Flow|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420797|NCT00561951|P1|Participant Flow|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420798|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420799|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420800|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420801|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420802|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420803|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420804|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420805|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420806|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420807|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420808|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420809|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420810|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420811|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420812|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420813|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420814|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420815|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420816|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420817|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420818|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420819|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420820|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420821|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420822|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420823|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420824|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420825|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420826|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420827|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420828|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420829|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420830|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420831|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420832|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420833|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420834|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420835|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420836|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
424905|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
420838|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420839|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420840|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420841|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420842|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420843|NCT00561951|O3|Outcome|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420844|NCT00561951|O2|Outcome|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420845|NCT00561951|O1|Outcome|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420846|NCT00561951|E3|Reported Event|Fesoterodine 8 mg|Subjects were treated with Fesoterodine 8 mg/day for 12 weeks.
420847|NCT00561951|E2|Reported Event|Fesoterodine 4 mg|Subjects were treated with Fesoterodine 4 mg/day for 12 weeks.
420848|NCT00561951|E1|Reported Event|Placebo|Subjects were treated with placebo once daily for 12 weeks.
420849|NCT00561925|B4|Baseline|Total|Total of all reporting groups
420850|NCT00561925|B3|Baseline|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420851|NCT00561925|B2|Baseline|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420852|NCT00561925|B1|Baseline|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420853|NCT00561925|P5|Participant Flow|NVP IR to XR|
420854|NCT00561925|P4|Participant Flow|NVP XR|
420855|NCT00561925|P3|Participant Flow|NVP XR 400mg QD|Nevirapine extended release 400 mg given once daily
420856|NCT00561925|P2|Participant Flow|NVP IR 200mg BID|Nevirapine immediate release 200 mg given twice daily
420857|NCT00561925|P1|Participant Flow|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
420858|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously received nevirapine IR during the pre week 144
420859|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
420860|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
420861|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
420862|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420863|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420864|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420865|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420866|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420867|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420868|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420869|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420870|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420871|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420872|NCT00561925|O2|Outcome|NVP XR|Nevirapine extended release 400 mg tablets given once daily
420873|NCT00561925|O1|Outcome|NVP IR|Nevirapine immediate release 200 mg tablets given twice daily
420874|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
420875|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
420876|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
420877|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
420878|NCT00561925|O4|Outcome|XR-IR/XR|Patients receiving nevirapine XR during open label extension and previously receiving nevirapine IR during the pre week 144
420879|NCT00561925|O3|Outcome|IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
420880|NCT00561925|O2|Outcome|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
420881|NCT00561925|O1|Outcome|NVP IR|Patients received nevirapine IR during the 144 week blinded phase and nevirapine XR during open label extension
420882|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420883|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420884|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420885|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420886|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420887|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420888|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420889|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420890|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420891|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420892|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420893|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420894|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420895|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420896|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420897|NCT00561925|O3|Outcome|NVP XR 400mg QD|Nevirapine extended release 400 mg tablets given once daily
420898|NCT00561925|O2|Outcome|NVP IR 200mg BID|Nevirapine immediate release 200 mg tablets given twice daily
420899|NCT00561925|O1|Outcome|NVP IR 200mg QD|Nevirapine immediate release 200 mg tablets given once daily
420900|NCT00561925|E5|Reported Event|NVP XR-IR/XR|Patients receiving nevirapine XR during open label extension who had previously receiving nevirapine IR during the pre week 144
420901|NCT00561925|E4|Reported Event|NVP IR-IR/XR|Patients receiving nevirapine IR during the 144 week blinded phase and then receiving nevirapine XR in the post week 144 of extension
420902|NCT00561925|E3|Reported Event|NVP XR|Patients receiving nevirapine XR during the 144 week blinded phase and nevirapine XR during open label extension
420903|NCT00561925|E2|Reported Event|NVP IR|Patients received nevirapine IR during the 144 week blinded phase but who never took nevirapine XR during the open label extension
420904|NCT00561925|E1|Reported Event|NVP IR 200mg QD|Nevirapine immediate release 200 mg given once daily
420905|NCT00561912|B1|Baseline|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
420906|NCT00561912|P1|Participant Flow|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
420907|NCT00561912|O1|Outcome|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
420908|NCT00561912|E1|Reported Event|Decitabine + Interferon Alfa-2b|Decitabine 15 mg/m^2 intravenous (IV) daily over one hour for 5 days + Interferon Alfa-2b 0.5 million Units Subcutaneously Twice Daily Continuously, as of Cycle 3, Day 1.
420909|NCT00561834|B1|Baseline|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
420910|NCT00561834|P1|Participant Flow|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
420911|NCT00561834|O1|Outcome|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
420912|NCT00561834|E1|Reported Event|Ranibizumab|ranibizumab: 0.5mg ranibizumab given intravitreally as needed after initial treatment
420913|NCT00561821|B5|Baseline|Total|Total of all reporting groups
420914|NCT00561821|B4|Baseline|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420915|NCT00561821|B3|Baseline|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420916|NCT00561821|B2|Baseline|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420917|NCT00561821|B1|Baseline|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420918|NCT00561821|P4|Participant Flow|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420919|NCT00561821|P3|Participant Flow|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420920|NCT00561821|P2|Participant Flow|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420921|NCT00561821|P1|Participant Flow|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420922|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420923|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420924|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420925|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420926|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420927|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420928|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420929|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420930|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420931|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420932|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420933|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420934|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420935|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420936|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420937|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420938|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420939|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420940|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420941|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420942|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420943|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420944|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420945|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420946|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420947|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420948|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420949|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420950|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420951|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420952|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420953|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420954|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420955|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420956|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420957|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420958|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420959|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420960|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420961|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420962|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420963|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420964|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420965|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420966|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420967|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420968|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420969|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420970|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420971|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420972|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420973|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420974|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420975|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420976|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420977|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420978|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420979|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420980|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420981|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420982|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420983|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420984|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420985|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420986|NCT00561821|O4|Outcome|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420987|NCT00561821|O3|Outcome|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420988|NCT00561821|O2|Outcome|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420989|NCT00561821|O1|Outcome|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420990|NCT00561821|E4|Reported Event|Placebo|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one placebo tablet daily for 16 days, and then one placebo tablet daily for 7 days
420991|NCT00561821|E3|Reported Event|Esmirtazapine 3.0 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 3.0 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420992|NCT00561821|E2|Reported Event|Esmirtazapine 1.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 1.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420993|NCT00561821|E1|Reported Event|Esmirtazapine 0.5 mg|One placebo tablet daily for 14 days, followed by a double-blind treatment period of one 0.5 mg tablet Esmirtazapine daily for 16 days, and then one placebo tablet daily for 7 days
420994|NCT00561795|B3|Baseline|Total|Total of all reporting groups
420995|NCT00561795|B2|Baseline|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421034|NCT00561652|B2|Baseline|Arm 2|Chiropractic treatment plus Education plus exercise
420996|NCT00561795|B1|Baseline|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
420997|NCT00561795|P4|Participant Flow|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
420998|NCT00561795|P3|Participant Flow|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
420999|NCT00561795|P2|Participant Flow|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421000|NCT00561795|P1|Participant Flow|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421001|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421002|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421003|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421004|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421005|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421006|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421007|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421008|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421009|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421010|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421011|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421012|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421013|NCT00561795|O4|Outcome|A6-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421014|NCT00561795|O3|Outcome|A6-1|Paclitaxel 175 mg/m^2 plus carboplatin AUC6 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421015|NCT00561795|O2|Outcome|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421016|NCT00561795|O1|Outcome|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421017|NCT00561795|E2|Reported Event|A5-2|Paclitaxel 175 mg/m^2 plus carboplatin AUC5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 400 mg/day orally starting on Day 1 for the duration of the study
421018|NCT00561795|E1|Reported Event|A5-1|Paclitaxel 175 milligrams (mg)/square meter (m^2) plus carboplatin area under the concentration-time curve (AUC) 5 intravenously (IV) on Day 1 of a 21-day cycle for 6 cycles plus pazopanib 800 mg/day orally starting on Day 1 for the duration of the study
421019|NCT00561730|B1|Baseline|Pantoprazole|All patients enrolled
421020|NCT00561730|P1|Participant Flow|Pantoprazole|All patients enrolled
421021|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
421022|NCT00561730|O1|Outcome|Pantoprazole|Patients included and treated with at least one application of pantoprazole
421023|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
421024|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
421025|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid values at first and last visit
421026|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421027|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421028|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421029|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421030|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421031|NCT00561730|O1|Outcome|Pantoprazole|All patients with valid value at least at day 0
421032|NCT00561730|E1|Reported Event|Pantoprazole|Patients included and treated with at least one application of pantoprazole
421033|NCT00561652|B3|Baseline|Total|Total of all reporting groups
421038|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421039|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421040|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421041|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421042|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421043|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421044|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421045|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421046|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421047|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421048|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421049|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421050|NCT00561652|O2|Outcome|Arm 2|Chiropractic treatment plus education plus exercise
421051|NCT00561652|O1|Outcome|Arm 1|Education plus exercise
421052|NCT00561652|E2|Reported Event|Arm 2|Chiropractic treatment plus education plus exercise
421053|NCT00561652|E1|Reported Event|Arm 1|Education plus exercise
421054|NCT00561600|B3|Baseline|Total|Total of all reporting groups
421055|NCT00561600|B2|Baseline|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
421056|NCT00561600|B1|Baseline|ASR XL|ASR™-XL Acetabular Cup System
421057|NCT00561600|P2|Participant Flow|B Pinnacle™|Pinnacle™ acetabular shell, with a 28mm or 36mm ULTAMET® metal liner, and a 28mm or 36mm Articul/eze M head.
421058|NCT00561600|P1|Participant Flow|A ASR™-XL|ASR™-XL Modular Acetabular Cup System stem
421059|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421060|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421061|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421062|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421063|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421064|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421065|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421066|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421067|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421068|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421069|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421070|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421071|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421072|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421073|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421074|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421075|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421076|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421077|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421078|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421079|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421080|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421081|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421082|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421083|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421084|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421085|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421086|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421087|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421088|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421089|NCT00561600|O2|Outcome|Pinnacle MoM|Pinnacle metal on metal acetabular cup system
421090|NCT00561600|O1|Outcome|ASR XL|ASR™-XL Acetabular Cup System
421091|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421092|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421093|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421094|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421095|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421096|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421097|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421098|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421099|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421100|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421101|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421102|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421103|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421104|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421105|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421106|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421107|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421108|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421109|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421110|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421111|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421112|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421113|NCT00561600|O2|Outcome|Pinnacle Acetabular Cup System|
421114|NCT00561600|O1|Outcome|ASR XL Acetabular Cup System|
421115|NCT00561600|E2|Reported Event|Pinnacle Acetabular Cup System|
421116|NCT00561600|E1|Reported Event|ASR XL Acetabular Cup System|
421117|NCT00561574|B3|Baseline|Total|Total of all reporting groups
421118|NCT00561574|B2|Baseline|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421119|NCT00561574|B1|Baseline|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421120|NCT00561574|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421121|NCT00561574|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421122|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421123|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421124|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421125|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421126|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421127|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421128|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421129|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421130|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421131|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421132|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421133|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421134|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421135|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421136|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421137|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421138|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421139|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421140|NCT00561574|O2|Outcome|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421141|NCT00561574|O1|Outcome|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421142|NCT00561574|E2|Reported Event|Esmirtazapine 3.0 mg|Participants receive esmirtazapine 3.0 mg tablets, one tablet administered orally once daily for up to 52 weeks
421143|NCT00561574|E1|Reported Event|Esmirtazapine 1.5 mg|Participants receive esmirtazapine 1.5 mg tablets, one tablet administered orally once daily for up to 52 weeks
421144|NCT00561470|B3|Baseline|Total|Total of all reporting groups
421145|NCT00561470|B2|Baseline|Aflibercept/Folfiri|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
421146|NCT00561470|B1|Baseline|Placebo/Folfiri|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5- Fluorouracil, and Leucovorin)
421147|NCT00561470|P2|Participant Flow|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421148|NCT00561470|P1|Participant Flow|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421149|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Aflibercept and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
421150|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo and FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
421151|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421152|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421153|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421154|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421155|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421156|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421157|NCT00561470|O2|Outcome|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421158|NCT00561470|O1|Outcome|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421159|NCT00561470|E2|Reported Event|Aflibercept/FOLFIRI|Participants with Metastatic Colorectal Cancer administered 4 mg/kg of Aflibercept, followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421160|NCT00561470|E1|Reported Event|Placebo/FOLFIRI|Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) every two weeks
421161|NCT00561457|B1|Baseline|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
421162|NCT00561457|P1|Participant Flow|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
421163|NCT00561457|O1|Outcome|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
421164|NCT00561457|E1|Reported Event|Luminexx Iliac Stent and Delivery System|Bard® LUMINEXX* Iliac Stent and the Bard® LUMINEXX* 6F Iliac Stent systems.
421165|NCT00561431|B3|Baseline|Total|Total of all reporting groups
421166|NCT00561431|B2|Baseline|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
421167|NCT00561431|B1|Baseline|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
421168|NCT00561431|P2|Participant Flow|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
421169|NCT00561431|P1|Participant Flow|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
421170|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
421171|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
421172|NCT00561431|O2|Outcome|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
421173|NCT00561431|O1|Outcome|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
421174|NCT00561431|E2|Reported Event|High Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|High dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 35 ml/kg/hr
421175|NCT00561431|E1|Reported Event|Standard Dose Continuous Venovenous Hemodiafiltration (CVVHDF)|Standard dose Continuous Venovenous Hemodiafiltration (CVVHDF) at an effluent rate of 20 ml/kg/hr
421176|NCT00561418|B1|Baseline|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421177|NCT00561418|P1|Participant Flow|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post Hematopoietic Stem Cell Transplantation),days +56 to +66 (≈2 mos), and at Cycle 2 Day 1 (≈3 mos.), Cycle 3 Day 1 (≈4 mos.), Cycle 5 Day 1 (≈6 mos.),Cycle 7 Day 1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421178|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421179|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421180|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421181|NCT00561418|O1|Outcome|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421204|NCT00561353|B2|Baseline|TMC435 75mg (Cohort 1)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421182|NCT00561418|E1|Reported Event|Vorinostat (SAHA)|"Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles with the dose escalations.~vorinostat: Vorinostat (SAHA) will be administered orally starting approximately day +60 post HSCT for 21 consecutive days of a 28-day cycle for up to a maximum of 11 cycles.~Correlative studies: Laboratory as well as quality of life correlative studies will be obtained at days +26 to +38 (at approximately 1 month post HSCT),days +56 to +66 (≈2 mos), and at C2D1 (≈3 mos.), C3D1 (≈4 mos.), C5D1 (≈6 mos.),C7D1 (≈8 mos.), and off study (ideally at ≈12 mos.)"
421183|NCT00561392|B1|Baseline|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421184|NCT00561392|P1|Participant Flow|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421185|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421186|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421187|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421188|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421189|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421190|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421191|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421192|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421193|NCT00561392|O1|Outcome|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421194|NCT00561392|E1|Reported Event|Rivastigmine 5 and 10 cm^2 Patch|For the 1st 4 weeks of this 24 week study, patients were administered rivastigmine transdermally once daily via a 5 cm^2 patch. After the Week 4 assessment, patients were administered rivastigmine transdermally once daily via a 10 cm^2 patch, with adjustments as necessary for safety and tolerability.
421195|NCT00561353|B11|Baseline|Total|Total of all reporting groups
421196|NCT00561353|B10|Baseline|TMC435 200 mg (Cohort 5)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421197|NCT00561353|B9|Baseline|Placebo (Cohort 4)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421198|NCT00561353|B8|Baseline|TMC435 200 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421199|NCT00561353|B7|Baseline|TMC435 150 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421200|NCT00561353|B6|Baseline|TMC435 75 mg (Cohort 4)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421201|NCT00561353|B5|Baseline|Placebo (Cohort 2)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421202|NCT00561353|B4|Baseline|TMC435 200 mg (Cohort 2)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421203|NCT00561353|B3|Baseline|Placebo (Cohort 1)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421205|NCT00561353|B1|Baseline|TMC435 25 mg (Cohort 1)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421206|NCT00561353|P10|Participant Flow|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421207|NCT00561353|P9|Participant Flow|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421208|NCT00561353|P8|Participant Flow|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421209|NCT00561353|P7|Participant Flow|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421210|NCT00561353|P6|Participant Flow|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421211|NCT00561353|P5|Participant Flow|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421212|NCT00561353|P4|Participant Flow|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421213|NCT00561353|P3|Participant Flow|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421214|NCT00561353|P2|Participant Flow|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421215|NCT00561353|P1|Participant Flow|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421216|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421217|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421218|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421219|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421220|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421221|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421222|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421223|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421224|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421225|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421226|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421227|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421228|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421229|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421230|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421231|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421601|NCT00560833|E5|Reported Event|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421232|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421233|NCT00561353|O3|Outcome|TTMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421234|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421235|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421236|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421237|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421238|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421239|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421240|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421241|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421242|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421243|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421244|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421245|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421246|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421247|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421248|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421249|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon (PegIFNα-2a) on Days 1, 8, 15, and 22.
421250|NCT00561353|O6|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421251|NCT00561353|O5|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421252|NCT00561353|O4|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421253|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421254|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421255|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421256|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421257|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421258|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421259|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421260|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421261|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421491|NCT00560950|P1|Participant Flow|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
421262|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421263|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421264|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421265|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421266|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers in Cohort 5, Panel D received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421267|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421268|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421269|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421270|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421271|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421272|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421273|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by Placebo once daily coadministered with RBV for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421274|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421275|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421276|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421277|NCT00561353|O4|Outcome|Placebo (TMC435 75/150/200 mg) (Cohort 4, Panel C)|Treatment-experienced non-responders received Placebo identical in appearance to TMC435 75 mg, 150 mg, or 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421278|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421279|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421280|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421281|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421282|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panels A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421283|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panels A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421284|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421285|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panels A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421286|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421287|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421288|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421289|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421290|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421291|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421292|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421293|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421294|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421295|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421296|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421297|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421298|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo identical in appearance toTMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421299|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421300|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421301|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421302|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421303|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421304|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421305|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421306|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421307|NCT00561353|O4|Outcome|TMC435 200mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421308|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421309|NCT00561353|O2|Outcome|TMC435 75mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421310|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B).
421311|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421312|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421313|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421314|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421315|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421316|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421317|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421318|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg and 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421319|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421320|NCT00561353|O1|Outcome|TMC435 25 (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421321|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421322|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421323|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421324|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421325|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421326|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421327|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421328|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421329|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421330|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421331|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421332|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily for 28 days coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421333|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421334|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421335|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421336|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants in received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421337|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421338|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421339|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421340|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421341|NCT00561353|O5|Outcome|TMC435 200 mg (Cohort 5, Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421342|NCT00561353|O4|Outcome|Placebo (Cohort 4, Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421343|NCT00561353|O3|Outcome|TMC435 200 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421344|NCT00561353|O2|Outcome|TMC435 150 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421345|NCT00561353|O1|Outcome|TMC435 75 mg (Cohort 4, Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421346|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421347|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel B)|Treatment-naïve participants received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421348|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421349|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421350|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel B)|Treatment-naïve participants received TMC435 25 mg once daily coadministered with ribavirin (RBV) for 28 days + peginterferon alpha-2a (PegIFNα-2a) on Days 1, 8, 15, and 22.
421351|NCT00561353|O5|Outcome|Placebo (Cohort 2, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421352|NCT00561353|O4|Outcome|TMC435 200 mg (Cohort 2, Panel A)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421353|NCT00561353|O3|Outcome|Placebo (Cohort 1, Panel A)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421354|NCT00561353|O2|Outcome|TMC435 75 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22.
421355|NCT00561353|O1|Outcome|TMC435 25 mg (Cohort 1, Panel A)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22.
421356|NCT00561353|E11|Reported Event|All TMC435 (All Cohorts)|
421357|NCT00561353|E10|Reported Event|TMC435 200 mg (Cohort 5/Panel D)|Treatment-experienced relapsers received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421358|NCT00561353|E9|Reported Event|Placebo (Cohort 4/Panel C)|Treatment-experienced non-responders received placebo (identical in appearance to TMC435 75 mg, 150 mg, or 200 mg) once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421359|NCT00561353|E8|Reported Event|TMC435 200 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421360|NCT00561353|E7|Reported Event|TMC435 150 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 150 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421361|NCT00561353|E6|Reported Event|TMC435 75 mg (Cohort 4/Panel C)|Treatment-experienced non-responders received TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22.
421362|NCT00561353|E5|Reported Event|Placebo (Cohort 2/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 200 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421363|NCT00561353|E4|Reported Event|TMC435 200 mg (Cohort 2, Panel A and B)|Treatment-naïve participants received TMC435 200 mg once daily for 7 days followed by TMC435 200 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 200 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421364|NCT00561353|E3|Reported Event|Placebo (Cohort 1/Panel A and B)|Treatment-naïve participants received placebo (identical in appearance to TMC435 25 mg or 75 mg) once daily for 7 days followed by placebo once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR placebo once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421365|NCT00561353|E2|Reported Event|TMC435 75mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 75 mg once daily for 7 days followed by TMC435 75 mg once daily coadministered with RBV for 21 days + PegIFNα-2a on Days 8, 15, and 22 (Panel A) OR TMC435 75 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421366|NCT00561353|E1|Reported Event|TMC435 25 mg (Cohort 1/Panel A and B)|Treatment-naïve participants received TMC435 25 mg once daily for 7 days followed by TMC435 25 mg once daily coadministered with ribavirin (RBV) for 21 days + peginterferon alpha-2a (PegIFNα-2a) on Days 8, 15, and 22 (Panel A) OR TMC435 25 mg once daily coadministered with RBV for 28 days + PegIFNα-2a on Days 1, 8, 15, and 22 (Panel B)
421367|NCT00561340|B3|Baseline|Total|Total of all reporting groups
421368|NCT00561340|B2|Baseline|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
421369|NCT00561340|B1|Baseline|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
421492|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421493|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421370|NCT00561340|P2|Participant Flow|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
421371|NCT00561340|P1|Participant Flow|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
421372|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
421373|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
421374|NCT00561340|O2|Outcome|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
421375|NCT00561340|O1|Outcome|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
421376|NCT00561340|E2|Reported Event|Counseling by the Provider on Ways to Encourage Caloric Intake|"Behavioral intervention - Nutritional Counseling~Nutritional counseling: 50% randomized to nutritional counseling only"
421377|NCT00561340|E1|Reported Event|1 Can of Pediasure Supplement Plus Nutritional Counseling|"Pediasure and nutritional counseling~Pediasure: 50% will be randomized to pediasure with nutritional counseling"
421378|NCT00561145|B3|Baseline|Total|Total of all reporting groups
421379|NCT00561145|B2|Baseline|Elderly Men|Elderly men: 65-85 years of age
421380|NCT00561145|B1|Baseline|Young Men|Young men: 20-40 years of age
421381|NCT00561145|P2|Participant Flow|Elderly Men|"Elderly men should be 65-85 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
421382|NCT00561145|P1|Participant Flow|Young Men|"Young men should be 20-40 years of age. Men will be excluded based on the following exclusion criteria:~body mass index (BMI in kg/m2) less than 20 or higher than 30, adherence to a weight-reduction or medically prescribed diet, dementia (Mini-Mental State Examination score\21), diabetes, anemia, gastrointestinal disorders, use of drugs known to interfere with energy balance, or a history of medical or surgical events known to affect the study outcome."
421383|NCT00561145|O2|Outcome|Elderly Men|Elderly men: 65-85 years of age
421384|NCT00561145|O1|Outcome|Young Men|Young men: 20-40 years of age
421385|NCT00561145|E2|Reported Event|Elderly Men|Elderly men: 65-85 years of age
421386|NCT00561145|E1|Reported Event|Young Men|Young men: 20-40 years of age
421387|NCT00561015|B7|Baseline|Total|Total of all reporting groups
421388|NCT00561015|B6|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421389|NCT00561015|B5|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421390|NCT00561015|B4|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421391|NCT00561015|B3|Baseline|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421392|NCT00561015|B2|Baseline|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421393|NCT00561015|B1|Baseline|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421494|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421495|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421496|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421497|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421498|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421394|NCT00561015|P6|Participant Flow|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421395|NCT00561015|P5|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421396|NCT00561015|P4|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421397|NCT00561015|P3|Participant Flow|Pbo With Peg-IFN-alfa-2a+ RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421398|NCT00561015|P2|Participant Flow|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421399|NCT00561015|P1|Participant Flow|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis (inflammation of liver) C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421400|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421401|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421402|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421403|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421404|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421405|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421499|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421500|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421501|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421502|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421406|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421407|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421408|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421409|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421410|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421411|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421412|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421413|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421414|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421415|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421416|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421417|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421503|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421504|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421505|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421506|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421507|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421418|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421419|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421420|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421421|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421422|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421423|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421424|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421425|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421426|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421427|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421428|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421429|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421508|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421509|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421510|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421511|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421512|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421430|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421431|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421432|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421433|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421434|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421435|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421436|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421437|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421438|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421439|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421440|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421441|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421513|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421514|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421515|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421516|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421442|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421443|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421444|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421445|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421446|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421447|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421448|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421449|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421450|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421451|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421452|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421453|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421517|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421518|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421519|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421520|NCT00560950|O4|Outcome|2nd Revaccination Group Day 30|
421521|NCT00560950|O3|Outcome|2nd Revaccination Group Day 1|
421454|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421455|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421456|NCT00561015|O4|Outcome|TVR With Peg-IFN-alfa-2a on + RBV (T2/PR24) - Genotype 3|Participants who were never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421457|NCT00561015|O3|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421458|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421459|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421460|NCT00561015|O6|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421461|NCT00561015|O5|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421462|NCT00561015|O4|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421463|NCT00561015|O3|Outcome|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421464|NCT00561015|O2|Outcome|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421465|NCT00561015|O1|Outcome|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421522|NCT00560950|O2|Outcome|1st Revaccination Group Day 30|
421523|NCT00560950|O1|Outcome|1st Revaccination Group Day 1|
421524|NCT00560950|E2|Reported Event|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
421466|NCT00561015|E6|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421467|NCT00561015|E5|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421468|NCT00561015|E4|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3|Participants who were never treated for chronic hepatitis C genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421469|NCT00561015|E3|Reported Event|Pbo With Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2|Participants who were never treated for CHC genotype 2 received TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421470|NCT00561015|E2|Reported Event|TVR With Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which was continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 24 weeks.
421471|NCT00561015|E1|Reported Event|TVR Then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2|Participants who were never treated for chronic hepatitis C genotype 2 received telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants were then treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 microgram (mcg) was administered as a subcutaneous injection once a week. RBV was taken orally as 400 mg tablets 2 times a day. Total duration of treatment was 26 weeks.
421472|NCT00561002|B3|Baseline|Total|Total of all reporting groups
421473|NCT00561002|B2|Baseline|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421474|NCT00561002|B1|Baseline|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421475|NCT00561002|P2|Participant Flow|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421476|NCT00561002|P1|Participant Flow|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421477|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421478|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421479|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421480|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421481|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421482|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421483|NCT00561002|O2|Outcome|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421484|NCT00561002|O1|Outcome|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421485|NCT00561002|E2|Reported Event|Influenza Vaccine Primed|Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
421486|NCT00561002|E1|Reported Event|Influenza Vaccine Naive/Inadequately Primed|Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
421487|NCT00560950|B3|Baseline|Total|Total of all reporting groups
421488|NCT00560950|B2|Baseline|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
421489|NCT00560950|B1|Baseline|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
421490|NCT00560950|P2|Participant Flow|2nd Revaccination Group|Received 1st revaccination with Pneumovax 23 during the initial phase and 2nd revaccination in the extension phase
421600|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421525|NCT00560950|E1|Reported Event|1st Revaccination Group|Received primary vaccination with Pneumovax 23 during the initial phase and 1st revaccination in the extension phase
421526|NCT00560937|B3|Baseline|Total|Total of all reporting groups
421527|NCT00560937|B2|Baseline|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421528|NCT00560937|B1|Baseline|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421529|NCT00560937|P2|Participant Flow|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421530|NCT00560937|P1|Participant Flow|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421531|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421532|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421533|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421534|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421535|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421536|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421537|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421538|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421539|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421540|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421541|NCT00560937|O2|Outcome|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421542|NCT00560937|O1|Outcome|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421543|NCT00560937|E2|Reported Event|Placebo|Placebo dosing and tablets were identical to Pregnenolone.
421544|NCT00560937|E1|Reported Event|Pregnenolone|"Pregnenolone 100 mg in divided doses (50 mg BID) for 2 weeks, then~Pregnenolone 300 mg in divided doses (150 mg BID) for 2 weeks, then~Pregnenolone 500 mg in divided doses (250 mg BID) for 4 weeks."
421545|NCT00560885|B1|Baseline|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421546|NCT00560885|P1|Participant Flow|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421547|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421548|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421549|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421550|NCT00560885|O1|Outcome|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421551|NCT00560885|E1|Reported Event|AtriCure Bipolar System|"The AtriCure Synergy Bipolar Ablation system is used to create lesions outlined in the Maze IV procedure during a concomitant open cardiac surgical procedure.~AtriCure Bipolar System : Surgical bipolar radiofrequency ablation using the AtriCure Bipolar System"
421552|NCT00560859|B3|Baseline|Total|Total of all reporting groups
421553|NCT00560859|B2|Baseline|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421554|NCT00560859|B1|Baseline|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421555|NCT00560859|P2|Participant Flow|Watchful Waiting|"Children will be closely monitored during the primary 7 month monitoring period and will be re-evaluated for AT by an otolaryngologist at the end of that period. a~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421556|NCT00560859|P1|Participant Flow|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421557|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421558|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421559|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421560|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421561|NCT00560859|O2|Outcome|Watchful Waiting|"Children will be closely monitored during the primary 7-month monitoring period and re-evaluated for AT by an otolaryngologist after that period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421562|NCT00560859|O1|Outcome|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421563|NCT00560859|E2|Reported Event|Watchful Waiting|"Children will be closely monitored and re-evaluated for AT by an otolaryngologist after the primary 7 month monitoring period.~Watchful Waiting: Children will reevaluated for adenotonsillectomy (AT) after a 7 month primary monitoring period."
421564|NCT00560859|E1|Reported Event|Early AT Surgery|"Adenotonsillectomy (AT) - removal of tonsils and adenoids - performed within 4 weeks of the baseline visit.~Adenotonsillectomy (AT) - removal of adenoids and tonsils: Standard surgical intervention for treatment of Obstructive Sleep Apnea Syndrome."
421565|NCT00560833|B6|Baseline|Total|Total of all reporting groups
421566|NCT00560833|B5|Baseline|Esmertazapine 18 mg|Participants receive esmertazapine 18 mg, encapsulated tablet, PO, QD for up to 12 weeks
421567|NCT00560833|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421568|NCT00560833|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421569|NCT00560833|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421570|NCT00560833|B1|Baseline|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421571|NCT00560833|P5|Participant Flow|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421572|NCT00560833|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421573|NCT00560833|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421574|NCT00560833|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421575|NCT00560833|P1|Participant Flow|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421576|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421577|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421578|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421579|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421580|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421581|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421582|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421583|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421584|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421585|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421586|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421587|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421588|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421589|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421590|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421591|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421592|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421593|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421594|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421595|NCT00560833|O1|Outcome|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421596|NCT00560833|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine 18 mg, encapsulated tablets, PO, QD for up to 12 weeks
421597|NCT00560833|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421598|NCT00560833|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421599|NCT00560833|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421602|NCT00560833|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine 9 mg, encapsulated tablets, PO, QD for up to 12 weeks
421603|NCT00560833|E3|Reported Event|Esmirtazapine 4.5 mg|Participants receive esmirtazapine 4.5 mg, encapsulated tablets, PO, QD for up to 12 weeks
421604|NCT00560833|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine 2.25 mg, encapsulated tablets, PO, QD for up to 12 weeks
421605|NCT00560833|E1|Reported Event|Placebo|Participants receive placebo, encapsulated tablets, orally (PO), once daily (QD) for up to 12 weeks
421606|NCT00560794|B1|Baseline|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421607|NCT00560794|P1|Participant Flow|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421608|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421609|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421610|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421611|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421612|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421613|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks.
421614|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
421615|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab 15 μg/m²/day as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period.
421616|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421617|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421618|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421619|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421620|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421621|NCT00560794|O1|Outcome|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421622|NCT00560794|E1|Reported Event|Blinatumomab|Participants received blinatumomab as continuous intravenous infusion at constant flow rate over 4 weeks followed by a 2 week treatment-free period (defined as one treatment cycle), for up to a maximum of 10 cycles. The initial dose was 15 μg/m²/day. A dose increase to 30 μg/m²/day was permitted with evidence for insufficient response to blinatumomab treatment.
421623|NCT00560703|B3|Baseline|Total|Total of all reporting groups
421624|NCT00560703|B2|Baseline|Placebo|Sugar capsule, once per day for 84 days
421625|NCT00560703|B1|Baseline|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
421626|NCT00560703|P2|Participant Flow|Placebo|Sugar capsule, once per day for 84 days
421627|NCT00560703|P1|Participant Flow|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
421628|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
421629|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
421630|NCT00560703|O2|Outcome|Placebo|Sugar capsule, once per day for 84 days
421631|NCT00560703|O1|Outcome|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
421632|NCT00560703|E2|Reported Event|Placebo|Sugar capsule, once per day for 84 days
421633|NCT00560703|E1|Reported Event|COL-101 (Doxycycline, USP) Capsules|40 MG, Once per day for 84 days
421634|NCT00560612|B3|Baseline|Total|Total of all reporting groups
421635|NCT00560612|B2|Baseline|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
421636|NCT00560612|B1|Baseline|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
421637|NCT00560612|P2|Participant Flow|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
421638|NCT00560612|P1|Participant Flow|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
421639|NCT00560612|O2|Outcome|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
421640|NCT00560612|O1|Outcome|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
421641|NCT00560612|E2|Reported Event|Placebo|Week 0: Randomization to placebo for 1 week. Week 1: Placebo for 2 weeks (10-20mg). Week 3: Placebo for 2 weeks (10-20mg). Week 5: Placebo for 3 weeks (10-30mg). Week 8: Placebo for 4 weeks (10-40mg). Week 12: Final study visit (no study medication dispensed).
421642|NCT00560612|E1|Reported Event|Paroxetine|"Week 0: Randomization to paroxetine 10 mg per day for 1 week, Week 1: Paroxetine 10-20 mg/day for 2 weeks (increase to 20 mg/day if tolerating 10 mg/day dose without side effects).~Week 3: Paroxetine 10-20 mg per day for 2 weeks (increase to 20 mg/day, if tolerating 10 mg/day without side effects and if not already taking 20 mg/day).~Week 5: Paroxetine 10-30 mg per day for 3 weeks (increase to 30 mg/day if receiving 20 mg/day dose and tolerating without side effects).~Week 8: Paroxetine 10-40 mg per day for 4 weeks (increase to 40 mg/day if receiving 30 mg/day and tolerating without side effects).~Week 12: Final study visit (no study medication dispensed)."
421643|NCT00560573|B1|Baseline|All Participants|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421644|NCT00560573|P6|Participant Flow|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg, was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421645|NCT00560573|P5|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421646|NCT00560573|P4|Participant Flow|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The recommended phase 2 dose (R2PD) of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421647|NCT00560573|P3|Participant Flow|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421648|NCT00560573|P2|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421649|NCT00560573|P1|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 milligram (mg)/kilogram (kg) was administered intravenously (IV) on Day 1 of each cycle over 2.5 hours (hr) up to 6 cycles. Gemcitabine 1250 mg/meter square (m^2) was administered IV over approximately 30 minutes (min) on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421650|NCT00560573|O1|Outcome|Overall Participapnts|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421822|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421651|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421652|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421653|NCT00560573|O6|Outcome|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421654|NCT00560573|O5|Outcome|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of igitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421655|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421656|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421657|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421658|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421659|NCT00560573|O1|Outcome|Overall Population With PR and CR|Participants with PR and CR who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants with PR and CR who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421660|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421661|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421662|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421663|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Expansion With Pemetrexed|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421664|NCT00560573|O2|Outcome|Figitumumab 20 mg/kg With Gemcitabine and Cisplatin|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421665|NCT00560573|O1|Outcome|Overall Population|Participants who received figitumumab 6, 10, 20 mg/kg and at the RP2D of 20 mg/kg with increasing infusion rates in combination with standard doses of gemcitabine and cisplatin. Participants who received figitumumab at the RP2D in combination with pemetrexed and cisplatin.
421666|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421697|NCT00560573|E3|Reported Event|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421667|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421668|NCT00560573|O2|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421669|NCT00560573|O1|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421670|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421671|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421672|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 (absence) and on Day 1 of each cycle (presence) thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421673|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421674|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421675|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421676|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421677|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421678|NCT00560573|O4|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421679|NCT00560573|O3|Outcome|Cisplatin 75 mg/m^2/Pemetrexed Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421680|NCT00560573|O2|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 2)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421776|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
424906|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
421681|NCT00560573|O1|Outcome|Cisplatin 80 mg/m^2/Gemcitabine Expansion (Cycle 1)|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421682|NCT00560573|O1|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421683|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421684|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421685|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421686|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421687|NCT00560573|O4|Outcome|Figitumumab 20 mg/kg Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 to 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421688|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421689|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421690|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421691|NCT00560573|O3|Outcome|Figitumumab 20 mg/kg Dose Escalation|Figitumumab 20 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421692|NCT00560573|O2|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421693|NCT00560573|O1|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg, was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421694|NCT00560573|E6|Reported Event|Figitumumab 20 mg/kg Pemetrexed Expansion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Pemetrexed 500 mg/m^2 was administered IV over 10 min on Day 1 of each 21-day cycle up to 6 cycles. Cisplatin 75 mg/m^2 was administered IV over approximately 2 hr, following the completion of the pemetrexed treatment on Day 1 of each cycle up to 6 cycles.
421695|NCT00560573|E5|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 2.5 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 2.5 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421696|NCT00560573|E4|Reported Event|Figitumumab 20 mg/kg RP2D Expansion 1.0 Infusion|The RP2D of figitumumab 20 mg/kg was administered IV 24 hr after start of cisplatin infusion in Cycle 1 and on Day 1 of each cycle thereafter over 1 hr up to 17 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
424907|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
421698|NCT00560573|E2|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421699|NCT00560573|E1|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was administered IV on Day 1 of each cycle over 2.5 hr up to 6 cycles. Gemcitabine 1250 mg/m^2 was administered IV over approximately 30 min on Day 1 and Day 8 of each 21-day cycle up to 6 cycles. Cisplatin 80 mg/m^2 was administered IV over approximately 1 hr, following the completion of the gemcitabine treatment on Day 1 of each cycle up to 6 cycles.
421700|NCT00560560|B3|Baseline|Total|Total of all reporting groups
421701|NCT00560560|B2|Baseline|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421702|NCT00560560|B1|Baseline|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421703|NCT00560560|P2|Participant Flow|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421704|NCT00560560|P1|Participant Flow|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421705|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421706|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421707|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421708|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421709|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421710|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421711|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421712|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421713|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421714|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421715|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421716|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
422287|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
421717|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421718|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421719|NCT00560560|O2|Outcome|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421720|NCT00560560|O1|Outcome|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421721|NCT00560560|E2|Reported Event|Figitumumab 30 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 30 milligram/kilogram (mg/kg) was administered as an IV infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421722|NCT00560560|E1|Reported Event|Figitumumab 20 mg/kg|Figitumumab (CP-751,871) was given in 3-week cycles for a total of up to 17 cycles. Participants can receive treatment beyond 17 cycles provided clinical benefit is being achieved. Figitumumab 20 milligram/kilogram (mg/kg) was administered as an intravenous (IV) infusion on Day 1 and 2 in Cycle 1 (loading dose), and on Day 1 of every cycle thereafter.
421723|NCT00560508|B3|Baseline|Total|Total of all reporting groups
421724|NCT00560508|B2|Baseline|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421725|NCT00560508|B1|Baseline|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421726|NCT00560508|P2|Participant Flow|Pramipexole Immediate Release Group (PPX IR)|Pramipexole Immediate Release (IR) tablets of 0.125 mg and 0.5 mg dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421727|NCT00560508|P1|Participant Flow|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421728|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421729|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421730|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421731|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421732|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421733|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421734|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421735|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421736|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421737|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421738|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open-label period
421739|NCT00560508|O1|Outcome|Pramipexole ER: Open-Label Phase|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day during open label period
421740|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421741|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421742|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421743|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421777|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421744|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421745|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421746|NCT00560508|O2|Outcome|From PPX IR to PPX ER|From Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day for 12 weeks to Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421747|NCT00560508|O1|Outcome|From PPX ER to PPX ER|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421748|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421749|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421750|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421751|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421752|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421753|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421754|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421755|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421756|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421757|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421758|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421759|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421760|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421761|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421762|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421763|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421764|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421765|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421766|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421767|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421768|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421769|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421770|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421771|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421772|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421773|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421774|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421775|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421778|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421779|NCT00560508|O2|Outcome|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421780|NCT00560508|O1|Outcome|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421781|NCT00560508|E2|Reported Event|Pramipexole Immediate Release Group (PPX IR)|Pramipexole IR (tablets of 0.125 mg and 0.5 mg) dose: 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg, 2.0 mg, 2.5 mg, 3.0 mg, 3.5 mg, or 4.5 mg, twice or three times a day
421782|NCT00560508|E1|Reported Event|Pramipexole Extended Release Group (PPX ER)|Pramipexole ER (tablets of 0.375 mg and 1.5 mg) dose: 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, or 4.5 mg, once a day
421783|NCT00560417|B3|Baseline|Total|Total of all reporting groups
421784|NCT00560417|B2|Baseline|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421785|NCT00560417|B1|Baseline|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421786|NCT00560417|P2|Participant Flow|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421787|NCT00560417|P1|Participant Flow|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421788|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421789|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421790|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421791|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421792|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421793|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421794|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421795|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421796|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421797|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421798|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421799|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421800|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421801|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421802|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421803|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421804|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421805|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421806|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421807|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421808|NCT00560417|O2|Outcome|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421809|NCT00560417|O1|Outcome|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421810|NCT00560417|E2|Reported Event|Glargine|Insulin Glargine administered subcutaneously once a day at bedtime for 24 weeks
421811|NCT00560417|E1|Reported Event|ILPS|Insulin Lispro Protamine Suspension (ILPS) administered subcutaneously once a day at bedtime for 24 weeks
421812|NCT00560404|B3|Baseline|Total|Total of all reporting groups
421813|NCT00560404|B2|Baseline|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421814|NCT00560404|B1|Baseline|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421815|NCT00560404|P2|Participant Flow|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421816|NCT00560404|P1|Participant Flow|C.E.R.A.|Participants received RO0503821 (Continuous Erythropoietin Receptor Activator [C.E.R.A.]) with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421817|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421818|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421819|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421820|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421821|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
424908|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
421823|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421824|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421825|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421826|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421827|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421828|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421829|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421830|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421831|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421832|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421833|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421834|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421835|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421836|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421837|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421838|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421839|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421840|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421841|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421842|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421843|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421844|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421845|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421846|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421847|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421848|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421849|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421850|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421851|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421852|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421853|NCT00560404|O2|Outcome|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421854|NCT00560404|O1|Outcome|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421855|NCT00560404|E2|Reported Event|Epoetin Alpha|Participants received the same total dose of epoetin alpha administrated in the last week of screening period in the study, subcutaneously, three times a week, for 36 weeks.
421856|NCT00560404|E1|Reported Event|C.E.R.A.|Participants received C.E.R.A. with drug dosage of 120, 200 or 360 microgram subcutaneously, every four weeks, for 36 weeks.
421857|NCT00560391|B6|Baseline|Total|Total of all reporting groups
421918|NCT00560391|E1|Reported Event|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421858|NCT00560391|B5|Baseline|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose –finding phase and 13 participants treated in dose expansion phase.
421859|NCT00560391|B4|Baseline|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421860|NCT00560391|B3|Baseline|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421861|NCT00560391|B2|Baseline|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421862|NCT00560391|B1|Baseline|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421863|NCT00560391|P5|Participant Flow|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421864|NCT00560391|P4|Participant Flow|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421865|NCT00560391|P3|Participant Flow|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421866|NCT00560391|P2|Participant Flow|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421867|NCT00560391|P1|Participant Flow|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421868|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421869|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421870|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421871|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421872|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421873|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421874|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421875|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421876|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421877|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421878|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421879|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421880|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421881|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421882|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421883|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421884|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421885|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421886|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421887|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421888|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421889|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421890|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421891|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421892|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421893|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421894|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421895|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421896|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421897|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421919|NCT00560352|B4|Baseline|Total|Total of all reporting groups
421898|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421899|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421900|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421901|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421902|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421903|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421904|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421905|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421906|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421907|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421908|NCT00560391|O5|Outcome|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421909|NCT00560391|O4|Outcome|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421910|NCT00560391|O3|Outcome|Dasatinib 100 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421911|NCT00560391|O2|Outcome|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421912|NCT00560391|O1|Outcome|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421913|NCT00560391|O1|Outcome|All Treated Participants|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles; dasatinib (70/100 mg)QD for 28 days, dexamethasone (40mg)given weekly on Days 1, 8, 15, and 22 and lenalidomide (15/20/25mg)QD for 21 days.
421914|NCT00560391|E5|Reported Event|Dasatinib 70 mg + Lenalidomide 20 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 20 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421915|NCT00560391|E4|Reported Event|Dasatinib 70 mg + Lenalidomide 15 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 70 mg QD for 28 days and lenalidomide 15 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
421916|NCT00560391|E3|Reported Event|Dasatinib 140 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 140 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22). Cohort includes 4 participants treated for dose -finding phase and 13 participants treated in dose expansion phase.
421917|NCT00560391|E2|Reported Event|Dasatinib 100 mg + Lenalidomide 25 mg + Dexamethasone 40 mg|Participants were treated with a combination of dasatinib, lenalidomide and dexamethasone in 28 day cycles (dasatinib 100 mg QD for 28 days and lenalidomide 25 mg QD for 21 days, along with 40 mg QD of dexamethasone given weekly on Days 1, 8, 15, and 22).
422463|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
421920|NCT00560352|B3|Baseline|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421921|NCT00560352|B2|Baseline|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421922|NCT00560352|B1|Baseline|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421923|NCT00560352|P3|Participant Flow|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421924|NCT00560352|P2|Participant Flow|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421925|NCT00560352|P1|Participant Flow|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421926|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
421927|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421928|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421929|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421969|NCT00560235|P3|Participant Flow|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
424909|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
421930|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, QD or BID, depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
421931|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421932|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421933|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered BID, with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421934|NCT00560352|O3|Outcome|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421935|NCT00560352|O2|Outcome|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421936|NCT00560352|O1|Outcome|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421937|NCT00560352|O1|Outcome|All Treated|Dasatinib taken orally every day, once daily (QD) or twice daily (BID), depending on the assigned cohort dose level, in 21-day cycles. In a 21-day cycle, bortezomib was also administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was followed 1-2 hours later by the dose of bortezomib. In the dose-escalation phase (Part 1), participants were enrolled sequentially in groups of 3 and individually assessed for safety and dose-limiting toxicity.
421938|NCT00560352|E3|Reported Event|Dasatinib, 50 mg BID|Dasatinib, 50 mg administered twice daily (BID), with 1.0 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg once daily (QD), was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by intravenous (IV) bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, BID. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421939|NCT00560352|E2|Reported Event|Dasatinib, 140 mg QD|Dasatinib, 140 mg, administered QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing.In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421970|NCT00560235|P2|Participant Flow|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
422464|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
421940|NCT00560352|E1|Reported Event|Dasatinib, 100 mg QD|Dasatinib, 100 mg, given QD with 1.3 mg/m^2 of bortezomib in 21-day cycles. Dexamethasone, fixed at 20 mg QD, was administered the day of and 1 day after each bortezomib dosing. In a 21-day cycle, bortezomib was administered by IV bolus twice weekly, on Days 1, 4, 8, and 11, followed by a 10-day (Days 12 to 21) rest period. In a 21-day cycle, dasatinib was taken orally every day, QD in the morning. In a 21-day cycle, dexamethasone was taken orally on Days 1, 2, 4, 5, 8, 9, 11, and 12, at the same time as dasatinib. On the days when bortezomib and dasatinib were administered together, the morning dose of dasatinib was to be followed 1-2 hours by the dose of bortezomib.
421941|NCT00560313|B1|Baseline|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
421942|NCT00560313|P1|Participant Flow|4CMenB|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB
421943|NCT00560313|O4|Outcome|Men ACWY-CRM (One Dose)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post one dose of Men ACWY vaccine.
421944|NCT00560313|O3|Outcome|4CMenB (Post Dose 3)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 3.
421945|NCT00560313|O2|Outcome|4CMenB (Post Dose 2)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 2.
421946|NCT00560313|O1|Outcome|4CMenB (Post Dose 1)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. We report Numbers (%) of Subjects with Local and Systemic Reactions as indicators of Reactogenicity, by Vaccination post dose 1
421947|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421948|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421949|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421950|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421951|NCT00560313|O4|Outcome|MenACWY-CRM (Y)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421952|NCT00560313|O3|Outcome|MenACWY-CRM (W-135)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421953|NCT00560313|O2|Outcome|MenACWY-CRM (C)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421954|NCT00560313|O1|Outcome|MenACWY-CRM (A)|1 month postvaccination with quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
421955|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254) strain.
421956|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99) strain
421957|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
421958|NCT00560313|O3|Outcome|4CMen B (NZ98/254)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (NZ98/254)strain.
421959|NCT00560313|O2|Outcome|4CMenB (5/99)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against the (5/99)strain
421960|NCT00560313|O1|Outcome|4CMenB (44/76-SL)|All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB. Response was measured against (44/76-SL) strain
421961|NCT00560313|E4|Reported Event|Men ACWY-CRM|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1 MenACWY."
421962|NCT00560313|E3|Reported Event|4CMenB (3rd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 3."
421963|NCT00560313|E2|Reported Event|4CMenB (2nd Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 2."
421964|NCT00560313|E1|Reported Event|4CMenB (1st Vaccination)|"All participants were administered three doses of 4CMenB (0,2,6 months) and all were administered a single dose of MenACWY-CRM 1 month after the third dose of 4CMenB.~Post dose 1."
421965|NCT00560235|B4|Baseline|Total|Total of all reporting groups
421966|NCT00560235|B3|Baseline|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421967|NCT00560235|B2|Baseline|Figitumumab Dose Extension (Phase 1B)|Figitumumab 20 mg/kg or 30 mg/kg IV administered every 4 weeks (1 cycle). Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421968|NCT00560235|B1|Baseline|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
422465|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
421971|NCT00560235|P1|Participant Flow|Figitumumab Dose Escalation (Phase 1)|Figitumumab 20 milligrams per kilogram (mg/kg) intravenous (IV) administered every 4 weeks (1 cycle). If no dose-limiting toxicity (DLT) was identified in the 20-mg/kg cohort, dose escalation proceeded to 30-mg/kg. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421972|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421973|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
421974|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
421975|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
421976|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421977|NCT00560235|O2|Outcome|Figitumumab 30 mg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle).
421978|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV administered every 4 weeks (1 cycle).
421979|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421980|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421981|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
421982|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421983|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421984|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
421985|NCT00560235|O3|Outcome|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421986|NCT00560235|O2|Outcome|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421987|NCT00560235|O1|Outcome|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
421988|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421989|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421990|NCT00560235|O1|Outcome|Figitumumab 30 mg/kg (Phase 2)|Figitumumab 30 mg/kg IV administered every 4 weeks (1 cycle) for up to 12 cycles, unless unacceptable toxicity or participant withdrawal. Oral rapamycin at 2 to 4 mg/day could have been added as salvage therapy.
421991|NCT00560235|E8|Reported Event|Figitumumab 30 mg/kg + Rapamycin (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
421992|NCT00560235|E7|Reported Event|Figitumumab 30mg/kg (Phase 2)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle) until unacceptable toxicity or participant withdrawal, for up to 6 cycles.
421993|NCT00560235|E6|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
421994|NCT00560235|E5|Reported Event|Figitumumab 30 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
421995|NCT00560235|E4|Reported Event|Figitumumab 20 mg/kg + Rapamycin Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle). As optional salvage therapy for disease progression, oral rapamycin at 2 to 4 mg/day was administered in combination with figitumumab.
421996|NCT00560235|E3|Reported Event|Figitumumab 30 mg/kg Dose Extension (Phase 1B)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421997|NCT00560235|E2|Reported Event|Figitumumab 30 mg/kg Dose Escalation (Phase 1)|Figitumumab 30 mg/kg IV was administered every 4 weeks (1 cycle).
421998|NCT00560235|E1|Reported Event|Figitumumab 20 mg/kg Dose Escalation (Phase 1)|Figitumumab 20 mg/kg IV was administered every 4 weeks (1 cycle).
421999|NCT00560105|B3|Baseline|Total|Total of all reporting groups
422000|NCT00560105|B2|Baseline|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422001|NCT00560105|B1|Baseline|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422288|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422002|NCT00560105|P2|Participant Flow|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422003|NCT00560105|P1|Participant Flow|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422004|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422005|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422006|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422007|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422008|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422009|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422010|NCT00560105|O2|Outcome|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422011|NCT00560105|O1|Outcome|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422285|NCT00558896|P2|Participant Flow|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422012|NCT00560105|E2|Reported Event|Lung Flute|Lung Flute : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422013|NCT00560105|E1|Reported Event|Acapella|Acapella : 8 weeks home use, twice daily The study consisted of a screening visit, two weeks of intervention-free run-in, a randomization visit and then on treatment clinic visits at 1, 2, 4, 6, and 8 weeks. Participants who met the inclusion/exclusion criteria on screening were enrolled and provided with a daily paper dairy to record symptoms and rescue albuterol use. In addition they were instructed to provide two 24 hr sputum collections over the next 2 weeks. A randomization visit was done within 2 weeks of the enrollment visit. Participants who were compliant with the 24 hr sputum collection and at least 50% of the daily dairy entries were randomized to either the Lung Flute® or the Acapella®
422014|NCT00560066|B3|Baseline|Total|Total of all reporting groups
422015|NCT00560066|B2|Baseline|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
422016|NCT00560066|B1|Baseline|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
422017|NCT00560066|P2|Participant Flow|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine.
422018|NCT00560066|P1|Participant Flow|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine.
422019|NCT00560066|O2|Outcome|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
422020|NCT00560066|O1|Outcome|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
422021|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422022|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422023|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422024|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
422025|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422026|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422027|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422028|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
422029|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422030|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422031|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422032|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
422033|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422034|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422035|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422036|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
422037|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422038|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422039|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422040|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of egg-derived influenza virus vaccine
422041|NCT00560066|O4|Outcome|cTIV (Elderly)|Subjects ≥61 years-old received one vaccination of cell-derived influenza virus vaccine
422042|NCT00560066|O3|Outcome|TIV (Elderly)|Subjects ≥61 years-old received one vaccination of egg-derived influenza virus vaccine
422043|NCT00560066|O2|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years-old received one vaccination of cell-derived influenza virus vaccine
422044|NCT00560066|O1|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years years-old received one vaccination of egg-derived influenza virus vaccine
422045|NCT00560066|E2|Reported Event|Cell Culture-derived Vaccine (cTIV)|Subjects received one vaccination of a cell-derived trivalent influenza virus vaccine
422046|NCT00560066|E1|Reported Event|Egg-derived Vaccine (TIV)|Subjects received one vaccination of a egg-derived trivalent influenza virus vaccine
422047|NCT00559988|B3|Baseline|Total|Total of all reporting groups
422048|NCT00559988|B2|Baseline|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
422049|NCT00559988|B1|Baseline|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
422466|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
422050|NCT00559988|P2|Participant Flow|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
422051|NCT00559988|P1|Participant Flow|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
422052|NCT00559988|O2|Outcome|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
422053|NCT00559988|O1|Outcome|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
422054|NCT00559988|E2|Reported Event|Physician-Directed OAC|In Control (Group 2), Home Monitoring is active for Safety Net alerts, but the remote AF/AFL data is not revealed to the patient or treating physician. These patients receive physician-directed oral anticoagulation therapy consistent with current standards of care.
422055|NCT00559988|E1|Reported Event|Home Monitoring Guided OAC|Home Monitoring is fully enabled and continuous remote surveillance data is available to investigators. Patients will be treated according to a predefined anticoagulation plan, which uses the total duration of AF/AFL combined with patients' CHADS2 score to determine the start, stop, and restart of oral anticoagulation therapy.
422056|NCT00559962|B9|Baseline|Total|Total of all reporting groups
422057|NCT00559962|B8|Baseline|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
422058|NCT00559962|B7|Baseline|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
422059|NCT00559962|B6|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
422060|NCT00559962|B5|Baseline|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
422061|NCT00559962|B4|Baseline|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
422062|NCT00559962|B3|Baseline|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
422063|NCT00559962|B2|Baseline|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
422064|NCT00559962|B1|Baseline|Placebo|Oral placebo every 4 weeks for 12 weeks
422065|NCT00559962|P8|Participant Flow|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
422066|NCT00559962|P7|Participant Flow|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
422067|NCT00559962|P6|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
422068|NCT00559962|P5|Participant Flow|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
422069|NCT00559962|P4|Participant Flow|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
422070|NCT00559962|P3|Participant Flow|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
422071|NCT00559962|P2|Participant Flow|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
422072|NCT00559962|P1|Participant Flow|Placebo|Oral placebo every 4 weeks for 12 weeks
422073|NCT00559962|O8|Outcome|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
422074|NCT00559962|O7|Outcome|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
422075|NCT00559962|O6|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
422076|NCT00559962|O5|Outcome|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
422077|NCT00559962|O4|Outcome|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
422078|NCT00559962|O3|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
422079|NCT00559962|O2|Outcome|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
422080|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
422081|NCT00559962|O2|Outcome|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
422082|NCT00559962|O1|Outcome|Placebo|Oral placebo every 4 weeks for 12 weeks
422083|NCT00559962|E8|Reported Event|AEGR-733 5 mg + Ezetimibe 10 mg|Oral lomitapide 5 mg + ezetimibe 10 mg every 4 weeks for 12 weeks
422084|NCT00559962|E7|Reported Event|AEGR-733 5 mg + Fenofibrate 145 mg|Oral lomitapide 5 mg + micronized fenofibrate 145 mg every 4 weeks for 12 weeks
422085|NCT00559962|E6|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|Oral lomitapide 5 mg + atorvastatin 20 mg every 4 weeks for 12 weeks
422086|NCT00559962|E5|Reported Event|AEGR-733 10 mg|Oral lomitapide 10 mg every 4 weeks for 12 weeks
422087|NCT00559962|E4|Reported Event|AEGR-733 7.5 mg|Oral lomitapide 7.5 mg every 4 weeks for 12 weeks
422088|NCT00559962|E3|Reported Event|AEGR-733 5 mg|Oral lomitapide 5 mg every 4 weeks for 12 weeks
422089|NCT00559962|E2|Reported Event|AEGR-733 2.5 mg|Oral lomitapide 2.5 mg every 4 weeks for 12 weeks
422090|NCT00559962|E1|Reported Event|Placebo|Oral placebo every 4 weeks for 12 weeks
422091|NCT00559949|B1|Baseline|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
422165|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422092|NCT00559949|P1|Participant Flow|Arm I|"Patients receive oral selumetinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of unacceptable toxicity or disease progression.~Laboratory Biomarker Analysis: Correlative studies~Selumetinib: Selumetinib was administered orally as a free base suspension at a dose of 100 mg twice daily for 28-day cycles. Those participants experiencing Common Terminology Criteria for Adverse Events (CTCAE) v3.0 grade 3 toxicity or worse had their dose reduced to 50 mg twice daily and then to 50 mg once daily, if necessary."
422093|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
422094|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
422095|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
422096|NCT00559949|O1|Outcome|All Evaluable Participants|Participants evaluable according to protocol guidelines at time of analysis.
422097|NCT00559949|E1|Reported Event|All Participants|All participants on study.
422098|NCT00559936|B1|Baseline|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
422099|NCT00559936|P1|Participant Flow|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
422100|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
422101|NCT00559936|O1|Outcome|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
422102|NCT00559936|E1|Reported Event|Topical Avastin 1.0%|Each patient will receive topical Avastin in one eye.
422103|NCT00559897|B1|Baseline|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
422104|NCT00559897|P1|Participant Flow|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
422105|NCT00559897|O1|Outcome|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
422106|NCT00559897|E1|Reported Event|3'-Deoxy-3'-[18F]FLT PET & Zoledronic Acid|"Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid~Single photon emission computed tomography. Patient should receive the dose of zoledronic acid within 48 hrs of the first '3'-deoxy-3'-[18F]FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~3'-deoxy-3'-[18F]FLT: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid.~Single photon emission computed tomography: Patient should receive the dose of zoledronic acid within 48 hours of the first FLT PET scan. The second FLT PET scan will be done 6-8 days after the dose of zoledronic acid."
422107|NCT00559754|B1|Baseline|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422108|NCT00559754|P1|Participant Flow|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|"Participants received doxorubicin 60 milligrams per square meter (mg/m^2) intravenously (IV) followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.~Participants then received bevacizumab 15 mg per kilogram (mg/kg) IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles."
422109|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422110|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422111|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422289|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422112|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422113|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422114|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422115|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422116|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422117|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422118|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422119|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422120|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422121|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422122|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422123|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422124|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422125|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422126|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422127|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422128|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422129|NCT00559754|O1|Outcome|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422130|NCT00559754|E1|Reported Event|Doxorubicin + Cyclophosphamide/Bevacizumab + Docetaxel|Participants received doxorubicin 60 mg/m^2 IV followed by cyclophosphamide 600 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles. Participants then received bevacizumab 15 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1, repeated every 3 weeks for a maximum of 4 cycles.
422254|NCT00559273|E1|Reported Event|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422255|NCT00559104|B3|Baseline|Total|Total of all reporting groups
422131|NCT00559637|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422132|NCT00559637|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 micrograms per kilogram (mcg/kg) of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422133|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422134|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422135|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422136|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422137|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422138|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422139|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422140|NCT00559637|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422141|NCT00559637|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously once a month. The starting dose was 1.2 mcg/kg of body weight. Further dose adjustments were performed during the study depending on the hemoglobin value. Total duration of treatment was 9 months for all participants in the study and up to 11 months if participants were shifted to dialysis.
422142|NCT00559585|B3|Baseline|Total|Total of all reporting groups
422143|NCT00559585|B2|Baseline|Intravenous (IV) Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
422144|NCT00559585|B1|Baseline|Subcutaneous (SC) Abatacept|Participants received 125 mg weekly SC abatacept injections (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. The Per Protocol (PP) Analysis Population (instead of the Intent-To-Treat Population) was used to perform primary and key secondary efficacy analyses as per regulatory guidelines for non-inferiority studies.
422145|NCT00559585|P2|Participant Flow|Intravenous (IV) Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
422146|NCT00559585|P1|Participant Flow|Subcutaneous (SC) Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. During the Open Label Long Term (LT) Period, participants in both the Main Study and the Anti-TNF Failure Sub-study switched to open-label SC abatacept. The study continued until SC formulation became commercially available on a country basis or the Sponsor terminated the study.
422286|NCT00558896|P1|Participant Flow|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422147|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422148|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422149|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422150|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422151|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422152|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422153|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422154|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422155|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422156|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422157|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422158|NCT00559585|O1|Outcome|Open-Label SC Abatacept Long Term Period|During the Open-Label LT Period, participants could either continue with or switch to 125 mg weekly SC abatacept injections until the SC formulation became commercially available on a country basis or the Sponsor terminated the study. The Anti-TNF Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period.
422159|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422160|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422161|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422162|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422163|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422164|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422166|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422167|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422168|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422169|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422170|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422171|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422172|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422173|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422174|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422175|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422176|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422177|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422178|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422179|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422180|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422181|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422182|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422458|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422183|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422184|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422185|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422186|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422187|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422188|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422189|NCT00559585|O2|Outcome|Intravenous (IV) Abatacept|During the Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422190|NCT00559585|O1|Outcome|Subcutaneous (SC) Abatacept|During the Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an intravenous [IV] abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population.
422191|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422192|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception
422193|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo).
422194|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment.
422195|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (Subcutaneous placebo placebo).
422196|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422197|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422198|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422199|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422200|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of IV abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422201|NCT00559585|O2|Outcome|Intravenous Abatacept|Participants received IV abatacept infusions on Days 1, 15, and 29 and every 28 days thereafter. A double-dummy design was used to protect the blind, thus, participants also received subcutaneous injections of placebo (subcutaneous placebo).
422256|NCT00559104|B2|Baseline|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422202|NCT00559585|O1|Outcome|Subcutaneous Abatacept|Participants received weekly injections of 125 mg subcutaneous abatacept (with a loading dose of intravenous (IV) abatacept on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV placebo) with the exception that on Day 1, a loading dose of IV abatacept replaced the IV placebo treatment.
422203|NCT00559585|E2|Reported Event|SC Abatacept|During the Main Study Double Blind ST Period, participants received 125 mg weekly SC abatacept injections for 6 months (with an IV abatacept loading dose on Day 1, based on weight). A double-dummy design was used to protect the blind, thus, participants also received IV injections of placebo (IV Placebo) with the exception that on Day 1 a loading dose of IV abatacept replaced the IV Placebo treatment. An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could continue SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
422204|NCT00559585|E1|Reported Event|IV Abatacept|During the Main study Double Blind ST Period, participants received IV abatacept infusions on Days 1, 15, 29, and every 28 days, thereafter for 6 months. A double-dummy design was used to protect the blind, thus, participants also received SC injections of placebo (SC Placebo). An Anti-TNF Failure Sub-study was initiated (recruited separately from Main study) using the same treatment as the Main study in order to assess the immunogenicity and safety in the Anti-TNF Failure population. The Sub-study terminated due to low recruitment and participants were permitted to roll into the LT Open Label Period. During the Open Label LT Period, participants in both the Main Study and the Anti-TNF Failure Sub-study could switch to SC abatacept until the SC formulation became commercially available on a country basis or the Sponsor terminated the study.
422205|NCT00559507|B1|Baseline|Treatment (Saracatinib)|Patients will receive AZD0530 175mg orally daily for 4 weeks.
422206|NCT00559507|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
422207|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
422208|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
422209|NCT00559507|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
422210|NCT00559507|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
422211|NCT00559377|B1|Baseline|All Patients|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later.
422212|NCT00559377|P1|Participant Flow|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
422213|NCT00559377|O1|Outcome|Patients Who Had Response Determined by Clinical RECIST|
422214|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
422215|NCT00559377|O1|Outcome|Patients With IHC Measures|Patients who had tissue used to evaluate immunohistochemistry measures correlated to FMISO uptake where IHC scores were calculated by standard Allred values.
422216|NCT00559377|O1|Outcome|Disease-Free Survival|Patients who have remained disease-free throughout the 2 year follow up
422217|NCT00559377|O1|Outcome|2 Year Overall Survival|Patients who have not been declared deceased for 2 years after their last FMISO scan.
422218|NCT00559377|E1|Reported Event|Diagnostic (^18F FMISO PET and ^18F FDG PET)|Patients receive ^18F FMISO IV followed by PET scanning. Patients undergo a second ^18F FMISO PET scan 4-8 weeks later. Patients who have not had a prior ^18F FDG PET scan as part of their routine clinical management undergo ^18F FDG PET scanning at baseline.
422219|NCT00559364|B3|Baseline|Total|Total of all reporting groups
422220|NCT00559364|B2|Baseline|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422221|NCT00559364|B1|Baseline|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422222|NCT00559364|P2|Participant Flow|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422223|NCT00559364|P1|Participant Flow|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422224|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422459|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422225|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422226|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422227|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422228|NCT00559364|O2|Outcome|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422229|NCT00559364|O1|Outcome|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422230|NCT00559364|E2|Reported Event|Placebo|Patients received matching placebo, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422231|NCT00559364|E1|Reported Event|Viokase®|Patients received Viokase® 16, 22 tablets orally daily (that is, 6 tablets per meal and 2 tablets with 2 of 3 snacks) for 6 to 7 days in treatment phase. Patients on proton pump inhibitor (PPI) therapy during Screening continued their usual (those not using PPI therapy at screening received omeprazole 20 milligram orally once daily) throughout the study.
422232|NCT00559273|B3|Baseline|Total|Total of all reporting groups
422233|NCT00559273|B2|Baseline|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422234|NCT00559273|B1|Baseline|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422235|NCT00559273|P2|Participant Flow|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422236|NCT00559273|P1|Participant Flow|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered subcutaneously (SC) at a starting dose of 1.2 microgram per kilogram (mcg/kg) once every 4 weeks for 28 weeks.
422237|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422238|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422239|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422240|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422241|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422242|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422243|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422244|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422245|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422246|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422247|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422248|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422249|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422250|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422251|NCT00559273|O2|Outcome|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422252|NCT00559273|O1|Outcome|Mircera|Participants received Mircera (Methoxy polyethylene glycol-epoetin beta), administered SC at a starting dose of 1.2 mcg/kg once every 4 weeks for 28 weeks.
422253|NCT00559273|E2|Reported Event|Darbepoetin Alfa|Participants received darbepoetin alfa, administered SC once weekly or once every 2 weeks according to local labeling specifications for 28 weeks.
422460|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422257|NCT00559104|B1|Baseline|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422258|NCT00559104|P2|Participant Flow|nonTBI-based Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422259|NCT00559104|P1|Participant Flow|TBI-based Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422260|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422261|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422262|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422263|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422264|NCT00559104|O2|Outcome|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422265|NCT00559104|O1|Outcome|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422266|NCT00559104|E2|Reported Event|Carmustine in Conditioning|"Carmustine, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~carmustine~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~G-CSF"
422267|NCT00559104|E1|Reported Event|Irradiation in Conditioning|"total-body irradiation, etoposide, cyclophosphamide, infusion of peripheral blood stem cells, granulocyte-colony stimulating factor~cyclophosphamide~etoposide~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation~total-body irradiation~G-CSF"
422268|NCT00559013|B1|Baseline|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
422269|NCT00559013|P1|Participant Flow|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
422270|NCT00559013|O1|Outcome|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
422271|NCT00559013|E1|Reported Event|PSD Veritas Collagen Matrix Reinforcement Arm|Subjects receiving PSD Veritas Collagen Matrix for staple line reinforcement when undergoing open or laparoscopic colorectal surgery requiring the creation of an anastomosis.
422272|NCT00558896|B8|Baseline|Total|Total of all reporting groups
422273|NCT00558896|B7|Baseline|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422274|NCT00558896|B6|Baseline|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422275|NCT00558896|B5|Baseline|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422276|NCT00558896|B4|Baseline|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422277|NCT00558896|B3|Baseline|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422278|NCT00558896|B2|Baseline|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422279|NCT00558896|B1|Baseline|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422280|NCT00558896|P7|Participant Flow|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422281|NCT00558896|P6|Participant Flow|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422282|NCT00558896|P5|Participant Flow|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422283|NCT00558896|P4|Participant Flow|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422284|NCT00558896|P3|Participant Flow|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422601|NCT00558428|O1|Outcome|Amlodipine 5mg|
422290|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422291|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422292|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422293|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422294|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422295|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422296|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422297|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422298|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422299|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422300|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422301|NCT00558896|O7|Outcome|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422302|NCT00558896|O6|Outcome|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422303|NCT00558896|O5|Outcome|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422304|NCT00558896|O4|Outcome|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422305|NCT00558896|O3|Outcome|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422306|NCT00558896|O2|Outcome|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422307|NCT00558896|O1|Outcome|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422308|NCT00558896|E7|Reported Event|Relapsed Amyloidosis: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422309|NCT00558896|E6|Reported Event|Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-21 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422310|NCT00558896|E5|Reported Event|Relapsed Myeloma (< 4 Prior Regimens): High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422311|NCT00558896|E4|Reported Event|Bortezomib/Lenalidomide Relapsed/Refractory Myeloma: High Dose|"Pomalidomide: 4 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422312|NCT00558896|E3|Reported Event|Bortezomib/Lenalidomide Refractory/Relapsed Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422313|NCT00558896|E2|Reported Event|Lenalidomide Refractory Myeloma: Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422314|NCT00558896|E1|Reported Event|Relapsed Myeloma (<4 Prior Regimens): Low Dose|"Pomalidomide: 2 mg orally once daily, days 1-28 of 28 day cycle~Dexamethasone: 40 mg on days 1, 8, 15 ad 22 of 28 day cycle"
422315|NCT00558870|B3|Baseline|Total|Total of all reporting groups
422316|NCT00558870|B2|Baseline|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
422317|NCT00558870|B1|Baseline|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
422318|NCT00558870|P2|Participant Flow|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
422319|NCT00558870|P1|Participant Flow|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
422320|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
422321|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
422322|NCT00558870|O2|Outcome|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
422323|NCT00558870|O1|Outcome|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
422324|NCT00558870|E2|Reported Event|Morphine + Methadone|1 Dose oral Slow-Release Morphine (7.5 mg) plus oral Methadone dose (starting dose 2.5 mg) every 12 hours for 15 Days. Immediate-release morphine, if needed, for breakthrough pain.
422325|NCT00558870|E1|Reported Event|Morphine Only|2 Doses oral Slow-Release Morphine (7.5 mg) every 12 hours for 15 Days, and immediate-release morphine, if needed, for breakthrough pain.
422326|NCT00558831|B1|Baseline|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
422327|NCT00558831|P1|Participant Flow|Subjects|Each subject was randomized to applied benzoyl peroxide 2.5% cream formulation to one side of the face and benzoyl peroxide 2.5% cream formulation plus moisturizer to the other side of the face.
422328|NCT00558831|O2|Outcome|Benzoyl Peroxide 2.5% Cream Plus Moisturizing Lotion|
422329|NCT00558831|O1|Outcome|Benzoyl Peroxide 2.5% Cream|
422330|NCT00558831|E2|Reported Event|Benzoyl Peroxide 2.5% Plus Moisturizing Lotion|
422331|NCT00558831|E1|Reported Event|Benzoyl Peroxide 2.5%|
422332|NCT00558792|B4|Baseline|Total|Total of all reporting groups
422333|NCT00558792|B3|Baseline|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
422334|NCT00558792|B2|Baseline|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
422335|NCT00558792|B1|Baseline|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
422336|NCT00558792|P3|Participant Flow|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
422337|NCT00558792|P2|Participant Flow|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
422338|NCT00558792|P1|Participant Flow|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
422339|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422340|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422341|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422342|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422343|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422344|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422345|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422346|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422347|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422348|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422349|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422350|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422351|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422352|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422353|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422354|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422355|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422356|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422357|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422358|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422359|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422360|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422361|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422362|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422363|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422364|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422365|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422366|NCT00558792|O3|Outcome|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
422367|NCT00558792|O2|Outcome|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
422368|NCT00558792|O1|Outcome|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
422369|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422370|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422371|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422372|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422373|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422374|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422375|NCT00558792|O3|Outcome|Isovue 370, 90 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422376|NCT00558792|O2|Outcome|Isovue 370, 80 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 mL, at a rate of >4 mL/sec, followed by a 40 mL saline flush, administered at the same injection rate.
422377|NCT00558792|O1|Outcome|Isovue 370, 70 mL|Patients received a randomized total dose of Iopamidol injection 370, which could be 70, 80, or 90 milliliters (mL), at a rate of >4 mL per second (/sec), followed by a 40 mL saline flush, administered at the same injection rate.
422378|NCT00558792|E3|Reported Event|Isovue 370, 90 mL|iopamidol injection 370, 90 mL
422379|NCT00558792|E2|Reported Event|Isovue 370, 80 mL|iopamidol injection 370, 80 mL
422380|NCT00558792|E1|Reported Event|Isovue 370, 70 mL|iopamidol injection 370, 70 mL
422381|NCT00558753|B3|Baseline|Total|Total of all reporting groups
422382|NCT00558753|B2|Baseline|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422383|NCT00558753|B1|Baseline|1 Placebo|Half of the patients will receive PO placebo for 14 days
422384|NCT00558753|P2|Participant Flow|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422385|NCT00558753|P1|Participant Flow|1 Placebo|Half of the patients will receive oral (PO) placebo for 14 days
422386|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422387|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
422388|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422389|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
422390|NCT00558753|O2|Outcome|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422391|NCT00558753|O1|Outcome|1 Placebo|Half of the patients will receive PO placebo for 14 days
422392|NCT00558753|E2|Reported Event|2 Pregabalin|PO pregabalin 300 mg 2 hours prior to surgery, and 150 mg twice a day for 10 postoperative days. Pregabalin will be tapered to 75 mg twice daily between days 11 to 12 and then to 50 mg twice daily between days 13 to 14 post operatively and then stopped.
422393|NCT00558753|E1|Reported Event|1 Placebo|Half of the patients will receive PO placebo for 14 days
422394|NCT00558701|B3|Baseline|Total|Total of all reporting groups
422602|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422395|NCT00558701|B2|Baseline|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422396|NCT00558701|B1|Baseline|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing.~Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422397|NCT00558701|P2|Participant Flow|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422398|NCT00558701|P1|Participant Flow|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422399|NCT00558701|O2|Outcome|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422400|NCT00558701|O1|Outcome|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422401|NCT00558701|E2|Reported Event|Silverlon Alone|"Patients receiving treatment of skin donor sites with Silverlon wound contact dressing alone (i.e., without active electrical stimulation)~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422402|NCT00558701|E1|Reported Event|Microcurrent Stimulator + Silverlon|"Patients receiving active electrical stimulation (15-50 microamps) during treatment of skin donor sites with Silverlon wound contact dressing. Intervention is active electrical stimulation via microcurrent stimulator.~Microcurrent stimulator: Microcurrent stimulation from 15-50 microamps~Silverlon Wound Contact Dressing: Silver coated nylon dressing FDA approved for use on donor sites in burn patients"
422403|NCT00558636|B3|Baseline|Total|Total of all reporting groups
422404|NCT00558636|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422405|NCT00558636|B1|Baseline|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422406|NCT00558636|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422407|NCT00558636|P1|Participant Flow|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422408|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422409|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422410|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422411|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422412|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422413|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422414|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422461|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422462|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422415|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422416|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422417|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422418|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422419|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422420|NCT00558636|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422421|NCT00558636|O1|Outcome|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422422|NCT00558636|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Chemotherapy + Placebo: Placebo Group - Placebo (2 tablets twice daily, orally) on Study Days 2-19 and paclitaxel (175 mg/m^2 IV, over 2.5 to 4 hours) and carboplatin (AUC=5 IV, for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days
422423|NCT00558636|E1|Reported Event|Sorafenib + Paclitaxel + Carboplatin|Chemotherapy plus Multi Kinase Inhibitor: Sorafenib Group - Sorafenib (Nexavar, BAY43-9006), [400 mg, (2 tablets x 200 mg each) orally, twice daily] on Study Days 2-19 and paclitaxel (175 mg/m^2, intravenous (IV), over 2.5 to 4 hours) and carboplatin (area under the curve (AUC) =5, IV for 15 to 60 minutes) on Study Day 1. The cycle duration will be 21 days.
422424|NCT00558571|B5|Baseline|Total|Total of all reporting groups
422425|NCT00558571|B4|Baseline|100mg Empagliflozin|oral administration in the fasted state once daily.
422426|NCT00558571|B3|Baseline|25mg Empagliflozin|oral administration in the fasted state once daily.
422427|NCT00558571|B2|Baseline|10mg Empagliflozin|oral administration in the fasted state once daily.
422428|NCT00558571|B1|Baseline|Placebo|oral administration in the fasted state once daily.
422429|NCT00558571|P4|Participant Flow|100mg Empagliflozin|Oral administration in the fasted state once daily.
422430|NCT00558571|P3|Participant Flow|25mg Empagliflozin|Oral administration in the fasted state once daily.
422431|NCT00558571|P2|Participant Flow|10mg Empagliflozin|Oral administration in the fasted state once daily.
422432|NCT00558571|P1|Participant Flow|Placebo|Oral administration in the fasted state once daily
422433|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily
422434|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily
422435|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily
422436|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily
422437|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422438|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422439|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422440|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422441|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422442|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422443|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422444|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422445|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422446|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422447|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422448|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422449|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
422450|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
422451|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
422452|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
422453|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422454|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422455|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422456|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422457|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422603|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422467|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
422468|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
422469|NCT00558571|O4|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422470|NCT00558571|O3|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422471|NCT00558571|O2|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422472|NCT00558571|O1|Outcome|Placebo|Oral administration in the fasted state once daily.
422473|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422474|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422475|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422476|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422477|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422478|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422479|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422480|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422481|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422482|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422483|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422484|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422485|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422486|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422487|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422488|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422489|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422490|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422491|NCT00558571|O3|Outcome|100mg Empagliflozin|Oral administration in the fasted state once daily.
422492|NCT00558571|O2|Outcome|25mg Empagliflozin|Oral administration in the fasted state once daily.
422493|NCT00558571|O1|Outcome|10mg Empagliflozin|Oral administration in the fasted state once daily.
422494|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
422495|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
422496|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
422497|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
422498|NCT00558571|O4|Outcome|100mg Empagliflozin|oral administration in the fasted state once daily.
422499|NCT00558571|O3|Outcome|25mg Empagliflozin|oral administration in the fasted state once daily.
422500|NCT00558571|O2|Outcome|10mg Empagliflozin|oral administration in the fasted state once daily.
422501|NCT00558571|O1|Outcome|Placebo|oral administration in the fasted state once daily.
422502|NCT00558571|E4|Reported Event|100mg Empagliflozin|oral administration in the fasted state once daily
422503|NCT00558571|E3|Reported Event|25mg Empagliflozin|oral administration in the fasted state once daily
422504|NCT00558571|E2|Reported Event|10mg Empagliflozin|oral administration in the fasted state once daily
422505|NCT00558571|E1|Reported Event|Placebo|oral administration in the fasted state once daily
422506|NCT00558558|B1|Baseline|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
422507|NCT00558558|P1|Participant Flow|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
422508|NCT00558558|O1|Outcome|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
422509|NCT00558558|E1|Reported Event|Fermented Soy Supplement|4 oz Haelan orally twice daily for 8 weeks
422510|NCT00558467|B3|Baseline|Total|Total of all reporting groups
422511|NCT00558467|B2|Baseline|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422512|NCT00558467|B1|Baseline|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422513|NCT00558467|P2|Participant Flow|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422514|NCT00558467|P1|Participant Flow|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422515|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422516|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422517|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422518|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422604|NCT00558428|O2|Outcome|Amlodipine 10mg|
422605|NCT00558428|O1|Outcome|Amlodipine 5mg|
422606|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422519|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422520|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422521|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422522|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422523|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422524|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422525|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422526|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422527|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422528|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422529|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422530|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422531|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422532|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422533|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422534|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422535|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422536|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422537|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422538|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422539|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422540|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422541|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422542|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422543|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422544|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422545|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422546|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422547|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422548|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422607|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422549|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422550|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422551|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422552|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422553|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422554|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422555|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422556|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422557|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422558|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422559|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422560|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422561|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422562|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422563|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422564|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422565|NCT00558467|O2|Outcome|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422566|NCT00558467|O1|Outcome|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422567|NCT00558467|E2|Reported Event|Pramipexole|Pramipexole (tablets of 0.0625 mg, 0.125 mg and 0.25 mg) to be taken per os. Starting dose 0.0625 mg bid, with possible down titration after one week to 0.0625 mg qd or optional up titration to 0.125 mg bid, after the second week optional up titration to 0.125 mg tid, after the third week optional up titration to 0.25 mg bid.
422568|NCT00558467|E1|Reported Event|Placebo|Placebo tablets matching the Pramipexole tablets to be taken per os
422569|NCT00558428|B5|Baseline|Total|Total of all reporting groups
422570|NCT00558428|B4|Baseline|Telmisartan 80mg and Amlodipine 5mg|
422571|NCT00558428|B3|Baseline|Telmisartan 40mg and Amlodipine 5mg|
422572|NCT00558428|B2|Baseline|Amlodipine 10mg|
422573|NCT00558428|B1|Baseline|Amlodipine 5mg|
422574|NCT00558428|P4|Participant Flow|Telmisartan 80mg and Amlodipine 5mg|
422575|NCT00558428|P3|Participant Flow|Telmisartan 40mg and Amlodipine 5mg|
422576|NCT00558428|P2|Participant Flow|Amlodipine 10mg|
422577|NCT00558428|P1|Participant Flow|Amlodipine 5mg|
422578|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422579|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422580|NCT00558428|O2|Outcome|Amlodipine 10mg|
422581|NCT00558428|O1|Outcome|Amlodipine 5mg|
422582|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422583|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422584|NCT00558428|O2|Outcome|Amlodipine 10mg|
422585|NCT00558428|O1|Outcome|Amlodipine 5mg|
422586|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422587|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422588|NCT00558428|O2|Outcome|Amlodipine 10mg|
422589|NCT00558428|O1|Outcome|Amlodipine 5mg|
422590|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422591|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422592|NCT00558428|O2|Outcome|Amlodipine 10mg|
422593|NCT00558428|O1|Outcome|Amlodipine 5mg|
422594|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422595|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422596|NCT00558428|O2|Outcome|Amlodipine 10mg|
422597|NCT00558428|O1|Outcome|Amlodipine 5mg|
422598|NCT00558428|O4|Outcome|Telmisartan 80mg and Amlodipine 5mg|
422599|NCT00558428|O3|Outcome|Telmisartan 40mg and Amlodipine 5mg|
422600|NCT00558428|O2|Outcome|Amlodipine 10mg|
422615|NCT00558363|B2|Baseline|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422616|NCT00558363|B1|Baseline|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422617|NCT00558363|P2|Participant Flow|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422618|NCT00558363|P1|Participant Flow|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422619|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422620|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422621|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422622|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422623|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422624|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422625|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422626|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422627|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422628|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422629|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422630|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422631|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422632|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422633|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422634|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422635|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422636|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422637|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422638|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422639|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422640|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422641|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422642|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422643|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422644|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422645|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422646|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422647|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422648|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422649|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422650|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422651|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422652|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422653|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422654|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422655|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422656|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422657|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422658|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422659|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422660|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422661|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422662|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422663|NCT00558363|O2|Outcome|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422664|NCT00558363|O1|Outcome|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422665|NCT00558363|E2|Reported Event|Dutasteride 0.5 mg|Oral dose of 0.5 mg dutasteride capsule once daily for 2 years
422666|NCT00558363|E1|Reported Event|Placebo|Oral dose of 0.5 milligrams (mg) matching placebo capsule once daily for 2 years
422667|NCT00558285|B6|Baseline|Total|Total of all reporting groups
422668|NCT00558285|B5|Baseline|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422669|NCT00558285|B4|Baseline|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422670|NCT00558285|B3|Baseline|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422671|NCT00558285|B2|Baseline|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422672|NCT00558285|B1|Baseline|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422673|NCT00558285|P5|Participant Flow|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422674|NCT00558285|P4|Participant Flow|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422675|NCT00558285|P3|Participant Flow|Indacaterol/Glycopyrrolate 150 μg/100 μg|"One capsule indacaterol/glycopyrrolate 150 μg/50 μg and one capsule 50μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422676|NCT00558285|P2|Participant Flow|Indacaterol/Glycopyrrolate 300 μg/100 μg|"One capsule indacaterol/glycopyrrolate 300 μg/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422677|NCT00558285|P1|Participant Flow|Indacaterol/Glycopyrrolate 600 μg/100 μg|"Two capsules indacaterol/glycopyrrolate 300 μg/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422678|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422679|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422680|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422681|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422682|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422683|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422684|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422685|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422686|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422687|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422688|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422689|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422690|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422691|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422692|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422693|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422694|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422724|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422725|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422695|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422696|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422697|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422698|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422699|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422700|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422701|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422702|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422703|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422704|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422705|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422706|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422707|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422708|NCT00558285|O5|Outcome|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422709|NCT00558285|O4|Outcome|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422710|NCT00558285|O3|Outcome|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422711|NCT00558285|O2|Outcome|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422712|NCT00558285|O1|Outcome|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422713|NCT00558285|E5|Reported Event|Placebo|"Two placebo capsules delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol /albuterol as rescue medication was permitted throughout the study."
422714|NCT00558285|E4|Reported Event|Indacaterol 300 μg|"One capsule indacaterol 300 μg and one placebo capsule delivered via s single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422715|NCT00558285|E3|Reported Event|Indacaterol/Glycopyrrolate 150/100 μg|"One capsule indacaterol/glycopyrrolate 150/50 μg and one capsule 50 μg glycopyrrolate delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422716|NCT00558285|E2|Reported Event|Indacaterol/Glycopyrrolate 300/100 μg|"One capsule indacaterol/glycopyrrolate 300/100 μg and one placebo capsule delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422717|NCT00558285|E1|Reported Event|Indacaterol/Glycopyrrolate 600/100 μg|"Two capsules indacaterol/glycopyrrolate 300/50 μg delivered via a single dose dry powder inhaler in the morning for 14 days.~The use of salbutamol/albuterol as rescue medication was permitted throughout the study."
422718|NCT00558272|B3|Baseline|Total|Total of all reporting groups
422719|NCT00558272|B2|Baseline|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422720|NCT00558272|B1|Baseline|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422721|NCT00558272|P2|Participant Flow|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422722|NCT00558272|P1|Participant Flow|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422723|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422726|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422727|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422728|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422729|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422730|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422731|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422732|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422733|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422734|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422735|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422736|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422737|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422738|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422739|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422740|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422741|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422742|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422743|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422744|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422745|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422746|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422747|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422748|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422749|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422750|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422751|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422752|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422753|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422754|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422755|NCT00558272|O2|Outcome|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422756|NCT00558272|O1|Outcome|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422757|NCT00558272|E2|Reported Event|Zoledronic Acid 4 mg|Zoledronic Acid 4 mg on Day 1 of the 4-week treatment period
422758|NCT00558272|E1|Reported Event|AZD0530 175 mg|AZD0530 (saracatinib) 175 mg once daily
422759|NCT00558259|B3|Baseline|Total|Total of all reporting groups
422760|NCT00558259|B2|Baseline|Placebo|Matching placebo
422761|NCT00558259|B1|Baseline|Dabigatran|Dabigatran 150mg bid
422762|NCT00558259|P2|Participant Flow|Placebo|Matching placebo
422763|NCT00558259|P1|Participant Flow|Dabigatran|Dabigatran 150mg bid (twice daily)
422764|NCT00558259|O2|Outcome|Placebo|Matching placebo
422765|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422766|NCT00558259|O2|Outcome|Placebo|Matching placebo
422767|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422768|NCT00558259|O2|Outcome|Placebo|Matching placebo
422769|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422770|NCT00558259|O2|Outcome|Placebo|Matching placebo
422771|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422772|NCT00558259|O2|Outcome|Placebo|Matching placebo
422773|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422774|NCT00558259|O2|Outcome|Placebo|Matching placebo
422775|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422776|NCT00558259|O2|Outcome|Placebo|Matching placebo
422777|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422778|NCT00558259|O2|Outcome|Placebo|Matching placebo
422779|NCT00558259|O1|Outcome|Dabigatran|Dabigatran 150mg bid
422780|NCT00558259|E2|Reported Event|Placebo|Matching placebo
422781|NCT00558259|E1|Reported Event|Dabigatran|Dabigatran 150mg bid
422782|NCT00558246|B1|Baseline|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
422783|NCT00558246|P1|Participant Flow|Prineo and Suture|On same patient, one breast is randomized to control (intradermal sutures) and one breast is randomized to experimental arm (DERMABOND PROTAPE). Patient is own control. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
422784|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422785|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422786|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422787|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422788|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
424910|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
422789|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422790|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422791|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422792|NCT00558246|O2|Outcome|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422793|NCT00558246|O1|Outcome|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422794|NCT00558246|E3|Reported Event|Procedure|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422795|NCT00558246|E2|Reported Event|Suture|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422796|NCT00558246|E1|Reported Event|Prineo|On same patient, one breast is randomized to control and one breast is randomized to experimental arm. Patient is own control.
422797|NCT00558103|B6|Baseline|Total|Total of all reporting groups
422798|NCT00558103|B5|Baseline|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422799|NCT00558103|B4|Baseline|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422800|NCT00558103|B3|Baseline|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422801|NCT00558103|B2|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422802|NCT00558103|B1|Baseline|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422803|NCT00558103|P6|Participant Flow|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
422804|NCT00558103|P5|Participant Flow|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422805|NCT00558103|P4|Participant Flow|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422806|NCT00558103|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422807|NCT00558103|P2|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422808|NCT00558103|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422809|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422810|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422811|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422812|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422813|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422814|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422815|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422847|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422816|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422817|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422818|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422819|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422820|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422821|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422822|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422823|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422824|NCT00558103|O5|Outcome|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422825|NCT00558103|O4|Outcome|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422826|NCT00558103|O3|Outcome|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422827|NCT00558103|O2|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422828|NCT00558103|O1|Outcome|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422829|NCT00558103|E6|Reported Event|Open-label Lapatinib 1500 mg|Participants who received pazopanib 800 mg in the randomized treatment phase were given the option to receive oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) QD.
422830|NCT00558103|E5|Reported Event|Cohort 2: Lapatinib 1000 mg + Pazopanib 400 mg|Participants received oral lapatinib 1000 mg (4 x 250 mg tablets) and 2 x 250 mg placebo tablets in combination with pazopanib 400 mg (2 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422831|NCT00558103|E4|Reported Event|Cohort 2: Pazopanib 800 mg|Participants received oral pazopanib 800 mg (4 x 200 mg tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death. Participants who received pazopanib monotherapy and experienced unequivocal disease progression were given the option to receive lapatinib monotherapy in an open-label extension phase.
422832|NCT00558103|E3|Reported Event|Cohort 2: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) QD. The study treatment continued until participants experienced disease progression, unacceptable toxicity, or death.
422833|NCT00558103|E2|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib 800 mg|Participants received oral lapatinib 1500 mg (6 x 250 mg tablets) in combination with pazopanib 800 mg (2 x 400 mg tablets) QD.
422834|NCT00558103|E1|Reported Event|Cohort 1: Lapatinib 1500 mg + Pazopanib Placebo|Participants received oral lapatinib 1500 milligrams (mg) (6 x 250 mg tablets) in combination with placebo (matching to pazopanib; 2 tablets) once daily (QD).
422835|NCT00558064|B3|Baseline|Total|Total of all reporting groups
422836|NCT00558064|B2|Baseline|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422837|NCT00558064|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422838|NCT00558064|P2|Participant Flow|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422839|NCT00558064|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422840|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422841|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422842|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422843|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422844|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422845|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422846|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422848|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422849|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422850|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422851|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422852|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422853|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422854|NCT00558064|O2|Outcome|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422855|NCT00558064|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422856|NCT00558064|E2|Reported Event|Amlodipine 5 mg Monotherapy|A5 capsule, oral, once daily in the morning
422857|NCT00558064|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
422858|NCT00558025|B3|Baseline|Total|Total of all reporting groups
422859|NCT00558025|B2|Baseline|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422860|NCT00558025|B1|Baseline|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422861|NCT00558025|P2|Participant Flow|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422862|NCT00558025|P1|Participant Flow|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
422863|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422864|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422865|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422866|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422867|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422868|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422869|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422870|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422871|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422872|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422873|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422874|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422875|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422876|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422877|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422878|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422879|NCT00558025|O2|Outcome|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422880|NCT00558025|O1|Outcome|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422881|NCT00558025|E2|Reported Event|Pramipexole Immediate Release (IR)|0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
422882|NCT00558025|E1|Reported Event|Pramipexole Extended Release (ER)|0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
422883|NCT00558012|B3|Baseline|Total|Total of all reporting groups
422884|NCT00558012|B2|Baseline|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422885|NCT00558012|B1|Baseline|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422886|NCT00558012|P2|Participant Flow|Placebo|"Placebo~One-time dose: Intravenous saline"
422887|NCT00558012|P1|Participant Flow|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422888|NCT00558012|O2|Outcome|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422889|NCT00558012|O1|Outcome|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422890|NCT00558012|E2|Reported Event|Placebo|"Placebo~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422891|NCT00558012|E1|Reported Event|Active Medication Group|"One-time dose: Intravenous Zoledronic Acid 5.0 mg~Intravenous zoledronic acid: Intravenous zoledronic acid 5.0 mg once"
422892|NCT00557947|B1|Baseline|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
422893|NCT00557947|P1|Participant Flow|Dermabond Protape/Suture|Dermabond Protape-Incision segments are randomized & patient is own control. Incision segments are randomized such that each patient receives Dermabond Protape to close one side of the incision and Intradermal Sutures to close the other side of the incision. Protape is supplied as a single use mesh device with sufficient adhesive to saturate mesh. Sutures were not supplied.
422894|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
422895|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422896|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
422897|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422898|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
422899|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422900|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
422901|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422902|NCT00557947|O2|Outcome|Suture|Suture - Incision segments are randomized & patient is own control.
422903|NCT00557947|O1|Outcome|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422904|NCT00557947|E4|Reported Event|Unrelated|Reported events per local regulatory requirements but not related to either device or procedure.
422905|NCT00557947|E3|Reported Event|Procedure|
422906|NCT00557947|E2|Reported Event|Suture|Suture - Incision segments are randomized & patient is own control.
422907|NCT00557947|E1|Reported Event|Dermabond Protape|Dermabond Protape-Incision segments are randomized & patient is own control
422908|NCT00557856|B1|Baseline|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
422909|NCT00557856|P9|Participant Flow|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422910|NCT00557856|P8|Participant Flow|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422911|NCT00557856|P7|Participant Flow|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422912|NCT00557856|P6|Participant Flow|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422913|NCT00557856|P5|Participant Flow|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422914|NCT00557856|P4|Participant Flow|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422915|NCT00557856|P3|Participant Flow|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422916|NCT00557856|P2|Participant Flow|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422917|NCT00557856|P1|Participant Flow|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422918|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422919|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422920|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422921|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422922|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422923|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422924|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422925|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423490|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
422926|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422927|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422928|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422929|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422930|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422931|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422932|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422933|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422934|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422935|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422936|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422937|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422938|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422939|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422940|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422941|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422942|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422943|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422944|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422945|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422946|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422947|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422948|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422949|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422950|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422951|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422952|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424911|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
422953|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422954|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422955|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422956|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422957|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422958|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422959|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422960|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422961|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422962|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422963|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422964|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422965|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422966|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422967|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422968|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422969|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422970|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422971|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422972|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422973|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422974|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422975|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422976|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422977|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422978|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422979|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424912|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
422980|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422981|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422982|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422983|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422984|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422985|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422986|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422987|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422988|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422989|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422990|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422991|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422992|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422993|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422994|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422995|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422996|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422997|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422998|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
422999|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423000|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423001|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423002|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423003|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423004|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423005|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423006|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424913|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
423007|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423008|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423009|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423010|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423011|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423012|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423013|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423014|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423015|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423016|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423017|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423018|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423019|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423020|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423021|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423022|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423023|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423024|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423025|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423026|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423027|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423028|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423029|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423030|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423031|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423032|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423033|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424929|NCT00554216|E3|Reported Event|VI-0521 Top|PHEN/TPM 15/92
423034|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423035|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423036|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423037|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423038|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423039|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423040|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423041|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423042|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423043|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423044|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423045|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423046|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423047|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423048|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423049|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423050|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423051|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423052|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423053|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423054|NCT00557856|O1|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423055|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423056|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423057|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423058|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423059|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423060|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424930|NCT00554216|E2|Reported Event|VI-0521 Low|PHEN/TPM 3.75/23
423061|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423062|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423063|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423064|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423065|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423066|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423067|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423068|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423069|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423070|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423071|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423072|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423073|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423074|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423075|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423076|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423077|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423078|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423079|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423080|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423081|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423082|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423083|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423084|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423085|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423086|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423087|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
424931|NCT00554216|E1|Reported Event|Placebo|
423088|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423089|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423090|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423091|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423092|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423093|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423094|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423095|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423096|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423097|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423098|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg: Part 1|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423099|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423100|NCT00557856|O9|Outcome|PF-03446962 7 mg/kg: Part 2|PF-03446962 7 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423101|NCT00557856|O8|Outcome|PF-03446962 15 mg/kg: Part 1|PF-03446962 15 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423102|NCT00557856|O7|Outcome|PF-03446962 10 mg/kg: Part 1|PF-03446962 10 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423103|NCT00557856|O6|Outcome|PF-03446962 6.75 mg/kg: Part 1|PF-03446962 6.75 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423104|NCT00557856|O5|Outcome|PF-03446962 4.5 mg/kg: Part 1|PF-03446962 4.5 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423105|NCT00557856|O4|Outcome|PF-03446962 3 mg/kg: Part 1|PF-03446962 3 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423106|NCT00557856|O3|Outcome|PF-03446962 2 mg/kg : Part 1|PF-03446962 2 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423107|NCT00557856|O2|Outcome|PF-03446962 1 mg/kg|PF-03446962 1 mg/kg intravenous infusion over 1 hr on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423108|NCT00557856|O1|Outcome|PF-03446962 0.5 mg/kg: Part 1|PF-03446962 0.5 milligram per kilogram (mg/kg) intravenous infusion over 1 hour (hr) on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression, withdrawal by participant or unacceptable toxicity.
423109|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
423110|NCT00557856|O1|Outcome|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
423111|NCT00557856|E1|Reported Event|PF-03446962|All participants who received PF-03446962 intravenous infusion (0.5 milligram/kilogram [mg/kg], 1 mg/kg, 2 mg, 3 mg/kg, 4.5 mg/kg, 6.75 mg/kg, 10 mg/kg, 15 mg/kg, 7 mg/kg), on Day 1 of cycle 1 (28 days) and on Day 1 of subsequent cycles (14 days) until disease progression or unacceptable toxicity.
423112|NCT00557830|B4|Baseline|Total|Total of all reporting groups
423165|NCT00557505|B5|Baseline|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423166|NCT00557505|B4|Baseline|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
424103|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423113|NCT00557830|B3|Baseline|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423114|NCT00557830|B2|Baseline|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423115|NCT00557830|B1|Baseline|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423116|NCT00557830|P3|Participant Flow|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423117|NCT00557830|P2|Participant Flow|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423118|NCT00557830|P1|Participant Flow|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423119|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423120|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423121|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423122|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423123|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423167|NCT00557505|B3|Baseline|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423124|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423125|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423126|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423127|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423128|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423129|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423130|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423131|NCT00557830|O3|Outcome|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423132|NCT00557830|O2|Outcome|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423133|NCT00557830|O1|Outcome|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423134|NCT00557830|E3|Reported Event|Group B: Standard Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study.~Sorafenib Standard Dose :~Patients randomized to Group B will receive Dose Level 1 (sorafenib 400 mg po bid) until progression of disease, intolerable toxicity, patient refusal to continue with the study, or investigator decision to remove the patient from the study."
423168|NCT00557505|B2|Baseline|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423135|NCT00557830|E2|Reported Event|Group A: Escalated Dose|"Eligible patients will be randomized 2:1 to either Group A (escalated dose regimen) or Group B (standard dose regimen). Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12.~Sorafenib Escalated Dose :~Patients randomized to Group A will receive sorafenib 600 mg bid for Weeks 5 through 8 (Dose Level 2). Patients who tolerate this dose through Week 8 will be further escalated to Dose Level 3 (800 mg po bid) for Weeks 9 through 12."
423136|NCT00557830|E1|Reported Event|Screening Treatment Phase|After patients have signed informed consent and found to be eligible they will be started on standard dose sorafenib (800 mg/d) which constitutes the screening treatment phase. Patients who have been receiving treatment with commercial sorafenib outside of a clinical trial for < 2 weeks may also be able to participate in this trial provided all screening/baseline procedures are completed. During the screening treatment phase, commercial sorafenib will be prescribed. A patient will be eligible for randomization if (s)he successfully receives treatment with sorafenib for 4 weeks at 400 mg (po) bid (Study Weeks 1 through 4).
423137|NCT00557622|B3|Baseline|Total|Total of all reporting groups
423138|NCT00557622|B2|Baseline|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423139|NCT00557622|B1|Baseline|Placebo|Placebo once daily (OD)
423140|NCT00557622|P2|Participant Flow|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423141|NCT00557622|P1|Participant Flow|Placebo|Placebo once daily (OD)
423142|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423143|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423144|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423145|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423146|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423147|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423148|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423149|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423150|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423151|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423152|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423153|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423154|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423155|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423156|NCT00557622|O2|Outcome|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423157|NCT00557622|O1|Outcome|Placebo|Placebo once daily (OD)
423158|NCT00557622|E2|Reported Event|Paroxetine 20-50 mg/Day|Paroxetine 20 milligrams (mg)/day once daily (OD) for 2 weeks; titration up to 50 mg/day OD if necessary to achieve sufficient response. The last dose level in the treatment phase was reduced stepwise by one step every week to the final dose level of paroxetine 20 mg/day as part of a taper phase.
423159|NCT00557622|E1|Reported Event|Placebo|Placebo once daily (OD)
423160|NCT00557505|B10|Baseline|Total|Total of all reporting groups
423161|NCT00557505|B9|Baseline|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423162|NCT00557505|B8|Baseline|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423163|NCT00557505|B7|Baseline|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423164|NCT00557505|B6|Baseline|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
424104|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423169|NCT00557505|B1|Baseline|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423170|NCT00557505|P9|Participant Flow|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423171|NCT00557505|P8|Participant Flow|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423172|NCT00557505|P7|Participant Flow|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423173|NCT00557505|P6|Participant Flow|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423174|NCT00557505|P5|Participant Flow|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423175|NCT00557505|P4|Participant Flow|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423176|NCT00557505|P3|Participant Flow|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423177|NCT00557505|P2|Participant Flow|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423178|NCT00557505|P1|Participant Flow|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 milligram per kilogram (mg/kg) intravenously (IV) administered over 1 hour (hr) on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423179|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423180|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423181|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423182|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423183|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423184|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423185|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423186|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423187|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423188|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423189|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423190|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423191|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423192|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423193|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423194|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423195|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423196|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423197|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423198|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423199|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423200|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423201|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423202|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423203|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423204|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423205|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423206|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423207|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423208|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423209|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423210|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423211|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423212|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423213|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423214|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423215|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423216|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423217|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423218|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423219|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423220|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423221|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423222|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423223|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423224|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423225|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423226|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423227|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423228|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423229|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423230|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
424914|NCT00554229|E2|Reported Event|Placebo|Placebo oral tablet once daily
423231|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423232|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423233|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423234|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423235|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423236|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423237|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423238|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423239|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423240|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423241|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423242|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423243|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423244|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423245|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423246|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423247|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423248|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423249|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423250|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423251|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423252|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423253|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423254|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423255|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423256|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423257|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423258|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423259|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423260|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423261|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
424105|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423262|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423263|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423264|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423265|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423266|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423267|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423268|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423269|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423270|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423271|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423272|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423273|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423274|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423275|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423276|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423277|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423278|NCT00557505|O3|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423279|NCT00557505|O2|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423280|NCT00557505|O1|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423281|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423282|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423283|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423284|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423285|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423286|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423287|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423288|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423289|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423290|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423291|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423292|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
424106|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423293|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423294|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423295|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423296|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423297|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423298|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423299|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423300|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423301|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423302|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423303|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423304|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423305|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423306|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423307|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423308|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423309|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423310|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423311|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423312|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423313|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423314|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423315|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423316|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423317|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423318|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423319|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423320|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423321|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423322|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423323|NCT00557505|O9|Outcome|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
424915|NCT00554229|E1|Reported Event|ZD4054|ZD4054 10 mg oral tablet once daily
423324|NCT00557505|O8|Outcome|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423325|NCT00557505|O7|Outcome|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423326|NCT00557505|O6|Outcome|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423327|NCT00557505|O5|Outcome|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423328|NCT00557505|O4|Outcome|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423329|NCT00557505|O3|Outcome|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423330|NCT00557505|O2|Outcome|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423331|NCT00557505|O1|Outcome|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423332|NCT00557505|E9|Reported Event|PF-03732010 15.0 mg/kg Weekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423333|NCT00557505|E8|Reported Event|PF-03732010 8.0 mg/kg Weekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423334|NCT00557505|E7|Reported Event|PF-03732010 4.0 mg/kg Weekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (14 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 7 days).
423335|NCT00557505|E6|Reported Event|PF-03732010 15.0 mg/kg Biweekly|PF-03732010 infusion 15.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423336|NCT00557505|E5|Reported Event|PF-03732010 8.0 mg/kg Biweekly|PF-03732010 infusion 8.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423337|NCT00557505|E4|Reported Event|PF-03732010 4.0 mg/kg Biweekly|PF-03732010 infusion 4.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423338|NCT00557505|E3|Reported Event|PF-3732010 2.0 mg/kg Biweekly|PF-03732010 infusion 2.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423339|NCT00557505|E2|Reported Event|PF-03732010 1.0 mg/kg Biweekly|PF-03732010 infusion 1.0 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423340|NCT00557505|E1|Reported Event|PF-03732010 0.5 mg/kg Biweekly|PF-03732010 infusion 0.5 mg/kg IV administered over 1 hr on Day 1 of cycle 1 (28 days cycle) and subsequently on Day 1 of each cycle (dosing interval of 14 days).
423341|NCT00557492|B1|Baseline|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423342|NCT00557492|P1|Participant Flow|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423343|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423344|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423345|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423346|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423347|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423348|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423349|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
424916|NCT00554216|B4|Baseline|Total|Total of all reporting groups
423350|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423351|NCT00557492|O1|Outcome|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423352|NCT00557492|E1|Reported Event|FDR GEM + BEV +/- BEV/RT|Participants received fixed-dose rate (FDR) gemcitabine (GEM) (1,500 mg/m^2) plus bevacizumab (BEV) (10 mg/kg IV) every 2 weeks for three cycles followed by accelerated RT (30 Gy in 10 fractions) plus BEV directed at gross tumor volume plus a 1–2 cm vascular margin, +/- laparoscopy and resection after day 85.
423353|NCT00557466|B7|Baseline|Total|Total of all reporting groups
423354|NCT00557466|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423355|NCT00557466|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423356|NCT00557466|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423357|NCT00557466|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423358|NCT00557466|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423359|NCT00557466|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423360|NCT00557466|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423361|NCT00557466|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423362|NCT00557466|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423363|NCT00557466|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423364|NCT00557466|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423365|NCT00557466|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423366|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423367|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423368|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423369|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423370|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423371|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423372|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423373|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423374|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423375|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423376|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423377|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423378|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423379|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423380|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423381|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423382|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423383|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423384|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423385|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423386|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423387|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423388|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423389|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423390|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423391|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423392|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423393|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423394|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423395|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423396|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423397|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423398|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423399|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423400|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423401|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423402|NCT00557466|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423403|NCT00557466|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423404|NCT00557466|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423405|NCT00557466|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423406|NCT00557466|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423407|NCT00557466|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423408|NCT00557466|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® placebo) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423409|NCT00557466|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
423410|NCT00557466|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423411|NCT00557466|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423412|NCT00557466|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423413|NCT00557466|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
423414|NCT00557440|B4|Baseline|Total|Total of all reporting groups
423415|NCT00557440|B3|Baseline|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423434|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423416|NCT00557440|B2|Baseline|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423417|NCT00557440|B1|Baseline|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423418|NCT00557440|P3|Participant Flow|Pbo - Ind/M - FP/Salm|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423419|NCT00557440|P2|Participant Flow|FP/Salm - Pbo - Ind/M|"In Treatment Period 1 (Days 1 & 2) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone/salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423420|NCT00557440|P1|Participant Flow|Ind/M - FP/Salm - Pbo|"In Treatment Period 1 (Days 1 & 2) participants received indacaterol/mometasone (Ind/M) 500/400 μg via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening and placebo to fluticasone/salmeterol via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.~In Treatment Period 2 (Days 8 & 9) participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the evening and fluticasone /salmeterol (FP/Salm) 250/50 μg via MDDPI, one inhalation in the evening and one inhalation the following morning.~In Treatment Period 3 (Days 15 & 16) participants received 2 inhalations of placebo (Pbo) to indacaterol/mometasone via the TWISTHALER device in the evening and placebo to fluticasone/salmeterol via MDDPI, one inhalation in the evening and one inhalation the following morning.~Each treatment period was separated by a 6-day washout period."
423421|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423422|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423423|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423424|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423425|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423426|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423427|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423428|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423429|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423430|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423431|NCT00557440|O2|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423432|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423433|NCT00557440|O3|Outcome|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423435|NCT00557440|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423436|NCT00557440|E3|Reported Event|Placebo|Participants received placebo to indacaterol/mometasone via the TWISTHALER device and placebo to fluticasone/salmeterol via MDDPI.
423437|NCT00557440|E2|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via multi-dose dry powder inhaler (MDDPI), one inhalation in the evening and one inhalation the following morning.
423438|NCT00557440|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the evening.
423439|NCT00557362|B5|Baseline|Total|Total of all reporting groups
423440|NCT00557362|B4|Baseline|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
423441|NCT00557362|B3|Baseline|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423442|NCT00557362|B2|Baseline|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
423443|NCT00557362|B1|Baseline|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423444|NCT00557362|P4|Participant Flow|Topical Voriconazole Without Corneal De-epithelialization|"Topical voriconazole without corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423445|NCT00557362|P3|Participant Flow|Topical Voriconazole With Corneal De-epithelialization|"Topical voriconazole with corneal de-epithelialization.~Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423446|NCT00557362|P2|Participant Flow|Topical Natamycin Without Corneal De-epithelialization|"Topical natamycin without corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423447|NCT00557362|P1|Participant Flow|Topical Natamycin With Corneal De-epithelialization|"Topical natamycin with corneal de-epithelialization.~Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423448|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423449|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423450|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423451|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423452|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 5 patients in the natamycin arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
423453|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Note that 9 patients in the voriconazole arm had home visits conducted as their 3 month follow-up visit and scar size was not able to be obtained for these patients so they are not included in these analyses."
423454|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
423455|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole~Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake"
423456|NCT00557362|O2|Outcome|Topical Natamycin|"Drug: Natamycin 5%~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423457|NCT00557362|O1|Outcome|Topical Voriconazole|"Drug: Voriconazole Voriconazole prepared as a 1% solution.~One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake."
423458|NCT00557362|E4|Reported Event|Topical Natamycin Without Corneal De-epithelialization|Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
423459|NCT00557362|E3|Reported Event|Topical Natamycin With Corneal De-epithelialization|"Drug: Natamycin 5% One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423460|NCT00557362|E2|Reported Event|Topical Voriconazole Without Corneal De-epithelialization|Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.
423461|NCT00557362|E1|Reported Event|Topical Voriconazole With Corneal De-epithelialization|"Drug: Voriconazole Voriconazole prepared as a 1% solution. One drop of medication every one hour while awake for one week. For another 2 weeks, one drop of medication every 2 hours while awake.~Procedure/Surgery: Corneal de-epithelialization Corneal de-epithelialization at 1 week and 2 weeks from enrollment to increase epithelial penetration of antifungal medications."
423462|NCT00557349|B3|Baseline|Total|Total of all reporting groups
423463|NCT00557349|B2|Baseline|Famotidine|40 mg daily for 14 weeks
423464|NCT00557349|B1|Baseline|Omeprazole|40 mg daily for 14 weeks
423465|NCT00557349|P2|Participant Flow|Famotidine|40 mg daily at bedtime for 14 weeks
423466|NCT00557349|P1|Participant Flow|Omeprazole|40 mg daily at bedtime for 14 weeks
423467|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
423468|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
423469|NCT00557349|O2|Outcome|Famotidine|40 mg daily at bedtime for 14 weeks
423470|NCT00557349|O1|Outcome|Omeprazole|40 mg daily at bedtime for 14 weeks
423471|NCT00557349|E2|Reported Event|Famotidine|40 mg daily for 14 weeks
423472|NCT00557349|E1|Reported Event|Omeprazole|40 mg daily for 14 weeks
423473|NCT00557323|B1|Baseline|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
423474|NCT00557323|P1|Participant Flow|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
423475|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
423476|NCT00557323|O1|Outcome|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
423477|NCT00557323|E1|Reported Event|5-Year Observational Period|Followed subjects previously exposed to lanthanum carbonate in study SPD405-309 (NCT00150540). Subjects were not issued investigational medicinal product. Subjects could be treated for hyperphosphatemia as prescribed by their physician during the study, although this was not required for participation. Treatment was not restricted by the protocol, and it could include treatment with lanthanum carbonate or any other phosphate binder as prescribed by the treating physician. Subjects were assessed every 6 months throughout the 5-year observational period. Data were collected on bone-related adverse events, serious adverse events and deaths.
423478|NCT00557310|B1|Baseline|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423479|NCT00557310|P1|Participant Flow|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423480|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423481|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423482|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423483|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423484|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423485|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423486|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423487|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423488|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423489|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
424917|NCT00554216|B3|Baseline|VI-0521 Top|PHEN/TPM 15/92
423491|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423492|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423493|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423494|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423495|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423496|NCT00557310|O1|Outcome|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423497|NCT00557310|E1|Reported Event|Teriparatide|20 microgram (mcg) teriparatide subcutaneous injection per day for 18 months, with possibility to continue for 24 months
423498|NCT00557284|B3|Baseline|Total|Total of all reporting groups
423499|NCT00557284|B2|Baseline|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423500|NCT00557284|B1|Baseline|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423501|NCT00557284|P2|Participant Flow|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423502|NCT00557284|P1|Participant Flow|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423503|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423504|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423505|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423506|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423507|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423508|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423509|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423510|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423511|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423512|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423513|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423514|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423515|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423516|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423517|NCT00557284|O2|Outcome|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423518|NCT00557284|O1|Outcome|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423519|NCT00557284|E2|Reported Event|Placebo Arm|Placebo : Oral granules or chewable tablet, POQD
423520|NCT00557284|E1|Reported Event|Treatment Arm|Montelukast : 4 mg oral granules for ages 12 - 23 months; 4 mg chewable tablet for 2 - 5 years of age; or 5 mg chewable tablet for 6 - 8 years of of age
423521|NCT00557245|B4|Baseline|Total|Total of all reporting groups
423522|NCT00557245|B3|Baseline|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423523|NCT00557245|B2|Baseline|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423524|NCT00557245|B1|Baseline|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423525|NCT00557245|P3|Participant Flow|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423526|NCT00557245|P2|Participant Flow|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423527|NCT00557245|P1|Participant Flow|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423528|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
423529|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423530|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423531|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
423532|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423533|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423534|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
423535|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423536|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423537|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423538|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423539|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423540|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
423541|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423542|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423543|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423544|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423545|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423546|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423547|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423548|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423549|NCT00557245|O3|Outcome|Placebo|Placebo TDF + Placebo FTC/TDF orally, once daily.
423550|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF): FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423551|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|Tenofovir Disoproxil Fumarate (TDF): TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423552|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423553|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423554|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423555|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423556|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423557|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423558|NCT00557245|O3|Outcome|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423559|NCT00557245|O2|Outcome|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423560|NCT00557245|O1|Outcome|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423561|NCT00557245|E3|Reported Event|Placebo|Placebo TDF & Placebo FTC/TDF, 1 tablet each daily.
423562|NCT00557245|E2|Reported Event|Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|FTC/TDF - 200 mg tablet, once daily + Placebo TDF orally, once daily
423563|NCT00557245|E1|Reported Event|Tenofovir Disoproxil Fumarate (TDF)|TDF 300 mg tablet, once daily + Placebo FTC/TDF orally, once daily.
423564|NCT00557076|B3|Baseline|Total|Total of all reporting groups
423565|NCT00557076|B2|Baseline|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
423566|NCT00557076|B1|Baseline|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
423567|NCT00557076|P2|Participant Flow|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
423568|NCT00557076|P1|Participant Flow|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
423569|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
423570|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
423571|NCT00557076|O2|Outcome|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
423572|NCT00557076|O1|Outcome|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
423573|NCT00557076|E2|Reported Event|Sham|"sham auditory stimulation~Sham Auditory Stimulation: The sham intervention is zero minutes of Familiar Voice Stimulation. Each day for 6 weeks 0 minutes of Familiar voice stimulation will be provided in 10 minute daily segments for 6 weeks. Each 10 minute recording is a digital recording of silence."
423574|NCT00557076|E1|Reported Event|FAST|"high dose of familiar voice stimulation~Familiar Voice Stimulation High Dose: The High Dose intervention is 1,680 minutes of Familiar Vocal Stimulation (FVs) provided in 40 minute daily segments at least 2 hours apart and for 6 weeks. Four CDs with 10 minutes of FVs preceded by the familiar voice calling out the subject's name, will be played (1 at a time) each day for 6 weeks providing 1,680 minutes of FVs."
423575|NCT00556998|B1|Baseline|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423576|NCT00556998|P1|Participant Flow|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423577|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423578|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423579|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423580|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423581|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423582|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423583|NCT00556998|O1|Outcome|All Treatments|Voriconazole intravenous (IV) loading dose (6 mg/kg) was administered in the morning and evening on Day 1, and the IV maintenance dose (4 mg/kg) was administered in the morning and evening on Days 2-7 (up to Day 20 if clinically indicated). The oral maintenance dosing regimen was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423584|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
423585|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
423586|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1.
423587|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423588|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423589|NCT00556998|O1|Outcome|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423590|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423591|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423592|NCT00556998|O1|Outcome|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423593|NCT00556998|E2|Reported Event|Voriconazole Oral|Oral maintenance dosing regimen (300 mg every 12 hours or 150 mg every 12 hours if subject weighed less than 40 kg) was administered following voriconazole IV and lasted 6.5 days (up to Day 30 if clinically indicated).
423594|NCT00556998|E1|Reported Event|Voriconazole IV|Voriconazole IV loading dose (6 mg/kg) in the morning and evening on Day 1 and multiple IV doses (4 mg/kg) in the morning and evening on Days 2 to 7 (up to Day 20 if clinically indicated).
423595|NCT00556972|B1|Baseline|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423596|NCT00556972|P1|Participant Flow|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423597|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423598|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423599|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423600|NCT00556972|O1|Outcome|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423601|NCT00556972|E1|Reported Event|Fecal Incontinence Management System|The product is a management system for use in fecal incontinence. It consists of a barrier with an attached pouch and a Bed Drainage Bag.
423602|NCT00556946|B1|Baseline|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains using Combined Photodynamic and Pulsed Dye Laser.
423603|NCT00556946|P1|Participant Flow|Combined Photodynamic and Pulsed Dye Laser Treatment|Treatment of Port Wine Stains: using Combined Photodynamic and Pulsed Dye Laser.
423604|NCT00556946|O1|Outcome|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
423605|NCT00556946|E1|Reported Event|Treatment of Port Wine Stains|"Treatment of Port Wine Stains~Treatment of Port Wine Stains: Treatment of Port Wine Stains"
423606|NCT00556933|B5|Baseline|Total|Total of all reporting groups
423607|NCT00556933|B4|Baseline|Divided-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofeti|"Kidney transplant receive the same treatment as in Group 2, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection.."
423608|NCT00556933|B3|Baseline|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant receive the same treatment as in Group 1, until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423609|NCT00556933|B2|Baseline|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423610|NCT00556933|B1|Baseline|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant patients receive 6 mg/kg of rATG as a single dose administered intravenously over <24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation. Chronic maintenance immunosuppression is with tacrolimus and sirolimus.~Sirolimus, oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~Tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423611|NCT00556933|P4|Participant Flow|Divided-dose rATG (1.5mg/kgx4),Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG, 1.5 mg/kg x 4) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
423612|NCT00556933|P3|Participant Flow|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG, 6 mg/kg x 1) and maintained on tacrolimus and sirolimus for chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.
423613|NCT00556933|P2|Participant Flow|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|Kidney transplant recipients given 4 small doses (1.5 mg/kg) of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
423614|NCT00556933|P1|Participant Flow|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) (6 mg/kg) and maintained on tacrolimus and sirolimus for chronic immunosuppression.
423615|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423616|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
424918|NCT00554216|B2|Baseline|VI-0521 Low|PHEN/TPM 3.75/23
423617|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423618|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423619|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423620|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423621|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423622|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423623|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423624|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
424107|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423625|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423626|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423627|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
423628|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
423629|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423630|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423631|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423632|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423633|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423634|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423635|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423636|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423637|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423638|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423639|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4); Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423640|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
424108|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423641|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423642|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423643|NCT00556933|O4|Outcome|Divided-dose rATG(1.5mg/kgx4), Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423644|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423645|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423646|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423647|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423648|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
424109|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423649|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423650|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423651|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423652|NCT00556933|O3|Outcome|Ingle-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423653|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423654|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423655|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
423656|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
423657|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423658|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423659|NCT00556933|O4|Outcome|Divided-dose rATG(6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney."
423660|NCT00556933|O3|Outcome|Single-dose rATG (6mg/kg ) and Sirolimus/Mycophenolate Mofetil|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus chronic immunosuppression until tacrolimus is replaced with mycophenolate mofetil after about 6 months.~Rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~Mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels."
423661|NCT00556933|O2|Outcome|Divided-dose rATG (1.5mg/kg x 4) and Tacrolimus/Sirolimus|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423662|NCT00556933|O1|Outcome|Single Dose rATG (6 mg/kg x 1) and Tacrolimus/Sirolimus|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423663|NCT00556933|E4|Reported Event|Group 4|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and is required indefinitely to prevent rejection of the transplanted kidney.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough leve"
423664|NCT00556933|E3|Reported Event|Group 3|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression; tacrolimus is replaced with mycophenolate mofetil after about 6 months.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~mycophenolate mofetil: Patients are switched approximately 6 months after kidney transplantation from maintenance immunosuppression with tacrolimus and sirolimus to maintenance with mycophenolate mofetil and sirolimus. The drug is administered orally, taken daily, with dose adjusted in proportion to measured blood levels, and i"
424110|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423665|NCT00556933|E2|Reported Event|Group 2|"Kidney transplant recipients given 4 small doses of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: 6 mg/kg rabbit anti-thymocyte globulin delivered in 4 doses of 1.5 mg/kg each, the first administered at the time of kidney transplantation. Subsequent doses are administered on days 2, 4, and 6.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423666|NCT00556933|E1|Reported Event|Group 1|"Kidney transplant recipients given a single large dose of rabbit anti-thymocyte globulin (rATG) and maintained on tacrolimus and sirolimus for chronic immunosuppression.~rabbit anti-thymocyte globulin: A single 6 mg/kg dose of rATG administered intravenously over 24 hours, beginning before kidney transplantation. Administration of the drug is begun as early as practical, usually after general anesthesia has been established but before surgery has started. The rATG is therefore administered for about two hours before blood flow is restored to the kidney undergoing transplantation.~sirolimus: Oral maintenance immunosuppressant administered daily, dose adjusted according to measured serum trough levels, continued indefinitely to prevent kidney rejection~tacrolimus: Oral maintenance immunosuppressant, taken daily, dose adjusted to maintain target blood trough levels, required indefinitely to prevent kidney rejection."
423667|NCT00556894|B4|Baseline|Total|Total of all reporting groups
423668|NCT00556894|B3|Baseline|Placebo|CF101: orally q12h
423669|NCT00556894|B2|Baseline|CF101 1mg|CF101: orally q12h
423670|NCT00556894|B1|Baseline|CF101 0.1mg|CF101: orally q12h
423671|NCT00556894|P3|Participant Flow|Placebo|Matching placebo
423672|NCT00556894|P2|Participant Flow|CF101 1mg|CF101 1mg orally q12 for 12 weeks
423673|NCT00556894|P1|Participant Flow|CF101 0.1mg|CF101 0.1mg orally q12 for 12 weeks
423674|NCT00556894|O3|Outcome|Placebo|
423675|NCT00556894|O2|Outcome|CF101 1mg|
423676|NCT00556894|O1|Outcome|CF101 0.1mg|
423677|NCT00556894|E3|Reported Event|Placebo|Matching Placebo q12 for 12 weeks
423678|NCT00556894|E2|Reported Event|CF101 1mg|CF101 1mg q12 for 12 weeks
423679|NCT00556894|E1|Reported Event|CF101 0.1mg|CF101 0.1mg q12 for 12 weeks
423680|NCT00556712|B3|Baseline|Total|Total of all reporting groups
423681|NCT00556712|B2|Baseline|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423682|NCT00556712|B1|Baseline|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423683|NCT00556712|P2|Participant Flow|Erlotinib, 150 Milligrams Per Day (mg/Day)|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423684|NCT00556712|P1|Participant Flow|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without progressive disease (PD) according to Response Evaluation Criteria in Solid Tumors (RECIST) were randomized to receive a placebo, orally (PO) as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423685|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423686|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423687|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423688|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423788|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423789|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423689|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423690|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423691|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423692|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423693|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423694|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423695|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423696|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423697|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423698|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423699|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423700|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423701|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423702|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423790|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
424111|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423703|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423704|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423705|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423706|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423707|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423708|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423709|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423710|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423711|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423712|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423713|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423714|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423715|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423716|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423791|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
424112|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423717|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423718|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423719|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423720|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423721|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423722|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423723|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423724|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423725|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423726|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423727|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423728|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423729|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423730|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423792|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
424919|NCT00554216|B1|Baseline|Placebo|
423731|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423732|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423733|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423734|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423735|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423736|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423737|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423738|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423739|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423740|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423741|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423742|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423743|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423744|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423793|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
424113|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
423745|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423746|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423747|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423748|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423749|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423750|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423751|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423752|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423753|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423754|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423755|NCT00556712|O2|Outcome|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423756|NCT00556712|O1|Outcome|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423757|NCT00556712|E2|Reported Event|Erlotinib, 150 mg/Day|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive erlotinib, 150 mg/day, PO as tablets from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423758|NCT00556712|E1|Reported Event|Placebo|Participants completed 4 cycles (3 or 4 week cycles) of a standard platinum based non-investigational chemotherapy according to local practice and in concordance with the local labeling instructions (chemotherapy run-in period). Participants who completed all 4 cycles of chemotherapy run-in without PD according to RECIST were randomized to receive a placebo, PO as tablets, daily, from randomization until PD, death, unacceptable toxicity, or end of study, up to 27 months.
423759|NCT00556673|B3|Baseline|Total|Total of all reporting groups
423794|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423760|NCT00556673|B2|Baseline|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
423761|NCT00556673|B1|Baseline|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
423762|NCT00556673|P2|Participant Flow|Placebo - Indacaterol/Mometasone|In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
423763|NCT00556673|P1|Participant Flow|Indacaterol/Mometasone - Placebo|In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days.
423764|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423765|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423766|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423767|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423768|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423769|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423770|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423771|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423772|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423773|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423774|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423775|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423776|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423777|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423778|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423779|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423780|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423781|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423782|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423783|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423784|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423785|NCT00556673|O1|Outcome|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423786|NCT00556673|O3|Outcome|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423787|NCT00556673|O2|Outcome|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
424018|NCT00555997|B1|Baseline|Placebo/Ziprasidone|Received placebo in first phase and ziprasidone in second phase
423795|NCT00556673|E3|Reported Event|Fluticasone/Salmeterol|Participants received fluticasone/salmeterol 250/50 μg via dry powder inhaler (DPI), one inhalation in the morning and one inhalation the following evening.
423796|NCT00556673|E2|Reported Event|Placebo|Participants received 2 inhalations of placebo to indacaterol/mometasone via the TWISTHALER device in the morning.
423797|NCT00556673|E1|Reported Event|Indacaterol/Mometasone|Participants received a single dose of indacaterol/mometasone 500/400 μg delivered via the TWISTHALER device (2 inhalations of 250/200 μg) in the morning.
423798|NCT00556543|B1|Baseline|All Study Subjects|
423799|NCT00556543|P1|Participant Flow|All Study Subjects|
423800|NCT00556543|O1|Outcome|All Study Subjects|
423801|NCT00556543|O1|Outcome|All Study Subjects|
423802|NCT00556543|O1|Outcome|All Study Subjects|
423803|NCT00556543|O1|Outcome|All Study Subjects|
423804|NCT00556543|O1|Outcome|All Study Subjects|
423805|NCT00556543|O1|Outcome|All Study Subjects|
423806|NCT00556543|O1|Outcome|All Study Subjects|
423807|NCT00556543|O1|Outcome|All Study Subjects|
423808|NCT00556543|O1|Outcome|All Study Subjects|
423809|NCT00556543|O1|Outcome|All Study Subjects|
423810|NCT00556543|O2|Outcome|Rib Fracture Repair for Persistent Rib Fracture Non-Union|Subjects had CT scan evidence of rib fracture non-union at least 3 months from injury date. Subjects were a median of 41.5 months (range 9 – 56 months) post-injury at the time of repair.
423811|NCT00556543|O1|Outcome|Acute Rib Fracture Repair|These 6 patients with acute injury underwent rib fracture repair a median of 11 days (range 4 – 18 days) post-injury.
423812|NCT00556543|E2|Reported Event|Chronic Rib Fracture Non-union Repair|
423813|NCT00556543|E1|Reported Event|Acute Rib Fracture Repair|
423814|NCT00556504|B3|Baseline|Total|Total of all reporting groups
423815|NCT00556504|B2|Baseline|Placebo|Placebo with convetional treatment for HCV patients
423816|NCT00556504|B1|Baseline|TCM-700C|TCM-700C, an add-on drug to conventional treatment of Hepatitis C
423817|NCT00556504|P2|Participant Flow|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423818|NCT00556504|P1|Participant Flow|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423819|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423820|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423821|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423822|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423823|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423824|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423825|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423826|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423827|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423828|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423829|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423830|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423831|NCT00556504|O2|Outcome|Placebo|"Placebo, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~Placebo : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
424019|NCT00555997|P4|Participant Flow|Phase 2 Placebo|Patients who received placebo in phase 2.
424020|NCT00555997|P3|Participant Flow|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
423832|NCT00556504|O1|Outcome|TCM-700C|"TCM-700C, an add-on drug to conventional treatment (peginterferon α-2b + ribavirin) of Hepatitis C~TCM-700C (530mg active ingredient/tablet) : 2 tablets t.i.d for 48 weeks peginterferon α-2b: (1.5 micrograms/kg) once weekly injection for 48 weeks ribavirin: 1000mg-1200mg daily for 48 weeks."
423833|NCT00556504|E2|Reported Event|Placebo (Safety Population)|Placebo with convetional treatment(PegIFN plus RBV) for HCV patients
423834|NCT00556504|E1|Reported Event|TCM-700C (Safety Population)|TCM-700C, an add-on drug to conventional treatment(PegIFN plus RBV)of Hepatitis C
423835|NCT00556491|B3|Baseline|Total|Total of all reporting groups
423836|NCT00556491|B2|Baseline|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
423837|NCT00556491|B1|Baseline|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
423838|NCT00556491|P2|Participant Flow|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
423839|NCT00556491|P1|Participant Flow|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
423840|NCT00556491|O2|Outcome|Placebo|
423841|NCT00556491|O1|Outcome|Minocycline|
423842|NCT00556491|E2|Reported Event|Placebo|placebo: placebo will be given for at least 4 doses pre-op to a maximum of 14 doses
423843|NCT00556491|E1|Reported Event|Minocycline|minocycline: given at least for 4 doses (200mg initially then 100mg every 12 hours until surgery)with maximum of 14 doses
423844|NCT00556478|B3|Baseline|Total|Total of all reporting groups
423845|NCT00556478|B2|Baseline|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423846|NCT00556478|B1|Baseline|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423847|NCT00556478|P2|Participant Flow|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423848|NCT00556478|P1|Participant Flow|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423849|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423850|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423851|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423852|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423853|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423854|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423855|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423856|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423857|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423858|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
424021|NCT00555997|P2|Participant Flow|Phase 1 Placebo|Subjects taking placebo in the first phase.
424022|NCT00555997|P1|Participant Flow|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
424023|NCT00555997|O4|Outcome|Phase 2 Placebo|Patients who received placebo in phase 2.
423859|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423860|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423861|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423862|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423863|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised to Placebo respectively if the patient meets all the entry criteria.~Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the active treatment and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423864|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised to PSD502 respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423865|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423866|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
424024|NCT00555997|O3|Outcome|Phase 2 Ziprasidone|Subjects taking ziprasidone in the second phase.
424025|NCT00555997|O2|Outcome|Phase 1 Placebo|Subjects taking placebo in the first phase.
423867|NCT00556478|O2|Outcome|Double-Blind Placebo / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423868|NCT00556478|O1|Outcome|Double-Blind Active / Open-Label Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423869|NCT00556478|E3|Reported Event|Open Label Phase|"Subjects will all receive PSD502 if they wish to continue in the trial.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423870|NCT00556478|E2|Reported Event|Double-Blind Placebo|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502 Placebo: The placebo is a metered dose aerosol spray that is identical in appearance to the PSD502 spray and contains the same propellant (norflurane) but has no lidocaine or prilocaine.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing.~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423871|NCT00556478|E1|Reported Event|Double-Blind Active|"Double-blind Phase: Subjects will be randomised in a 2:1 ratio of PSD502 or placebo respectively if the patient meets all the entry criteria.~PSD502, contains a mixture of lidocaine and prilocaine: PSD502 spray contains a mixture of lidocaine and prilocaine with Norflurane (HFA-134a) is used as both propellant and solvent. A single dose consists of 3 sprays applied to the glans penis.~Approximately 5 minutes before intercourse the study spray (PSD502 or Placebo) can be applied and any excess should be wiped off with a damp cloth or tissue.~During the initial 3 months double-blind phase of the study subjects should leave at least 24 hours between each dosing~During the subsequent 5 months open label Phase of the study subjects may use the spray for up to a maximum of 3 sexual encounters (intercourse) in a 24 hour period. Each sexual encounter (intercourse) when the spray is used must be separated by at least 4 hour period."
423872|NCT00556452|B4|Baseline|Total|Total of all reporting groups
423873|NCT00556452|B3|Baseline|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423874|NCT00556452|B2|Baseline|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423875|NCT00556452|B1|Baseline|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423876|NCT00556452|P3|Participant Flow|Clo/BU4 40mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 40 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423877|NCT00556452|P2|Participant Flow|Clo/BU4 30mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 30 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423878|NCT00556452|P1|Participant Flow|Clo/BU4 20mg/m^2|"Clofarabine/Busulfan x 4 : Clofarabine IV 20 mg/m^2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment."
423879|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
424026|NCT00555997|O1|Outcome|Phase 1 Ziprasidone|Subjects taking ziprasidone in the first phase.
424027|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
424028|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
423880|NCT00556452|O1|Outcome|Clo/BU4|"Study will start at the 2nd dose level of three Clofarabine levels, in combination with Busulfan. The Clofarabine level that each subsequent patient is treated at is determined by a method using continual reassessment.~After pre-conditioning, subjects will receive a peripheral blood stem cell transplant.~Total Lymphoid Irradiation : Total Lymphoid Irradiation (TLI) of 4 Gy, if cord blood transplant~Clofarabine/Busulfan x 4 : Clofarabine IV (dose levels)~1st dose level: 20 mg/m2/day x 5 days~2nd dose level: 30 mg/m2/day x 5 days~3rd dose level: 40 mg/m2/day x 5 days~Busulfan IV 3.2 mg/kg daily x 4 days~Peripheral blood stem cell transplant : Peripheral blood stem cell transplant, after pre-conditioning drug treatment"
423881|NCT00556452|O1|Outcome|Clo/Bu4|Experimental: Clo/BU4
423882|NCT00556452|E1|Reported Event|Clo/Bu4|
423883|NCT00556426|B1|Baseline|Participants Receiving a Filter|Patients who were at temporary, increased risk of pulmonary embolism requiring inferior vena cava (IVC) interruption, and for whom Recovery G2 Filter retrieval could reasonably be expected to occur within 6 months of device placement.
423884|NCT00556426|P1|Participant Flow|All Patients Receiving the Filter|All enrolled subjects
423885|NCT00556426|O1|Outcome|Fractured Filters|retrieval of the filter such that the entire filter is retrieved
423886|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
423887|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
423888|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
423889|NCT00556426|O1|Outcome|All Patients Receiving the Filter|All enrolled subjects
423890|NCT00556426|E1|Reported Event|All Patients Receiving the Filter|All enrolled subjects
423891|NCT00556400|B3|Baseline|Total|Total of all reporting groups
423892|NCT00556400|B2|Baseline|Sugar Pill|
423893|NCT00556400|B1|Baseline|Lo-ovral|1 tablet of lo-ovral is administered twice a day
423894|NCT00556400|P2|Participant Flow|Sugar Pill|
423895|NCT00556400|P1|Participant Flow|Lo-ovral|1 tablet of lo-ovral is administered twice a day
423896|NCT00556400|O2|Outcome|Sugar Pill|
423897|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
423898|NCT00556400|O2|Outcome|Sugar Pill|
423899|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
423900|NCT00556400|O2|Outcome|Sugar Pill|
423901|NCT00556400|O1|Outcome|Lo-ovral|1 tablet of lo-ovral is administered twice a day
423902|NCT00556400|E1|Reported Event|Sugar Pill|
423903|NCT00556374|B3|Baseline|Total|Total of all reporting groups
423904|NCT00556374|B2|Baseline|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423905|NCT00556374|B1|Baseline|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423906|NCT00556374|P2|Participant Flow|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423907|NCT00556374|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy (AIT).
423908|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423909|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423910|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423911|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423912|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423913|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423914|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423915|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423916|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423917|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423918|NCT00556374|O2|Outcome|Denosumab|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423919|NCT00556374|O1|Outcome|Placebo|Participants received placebo subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423920|NCT00556374|E2|Reported Event|Denosumab 60mg Q6M|Participants received 60 mg denosumab subcutaneous injection once every 6 months. All participants continued to receive an approved non-steroidal aromatase inhibitor therapy
423921|NCT00556374|E1|Reported Event|Placebo Q6M|Participants received placebo subcutaneous injection once every 6 months (Q6M). All participants continued to receive an approved non-steroidal aromatase inhibitor therapy.
423922|NCT00556322|B3|Baseline|Total|Total of all reporting groups
423923|NCT00556322|B2|Baseline|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423924|NCT00556322|B1|Baseline|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423925|NCT00556322|P2|Participant Flow|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423926|NCT00556322|P1|Participant Flow|Comparator|Participants received either pemetrexed 500 milligrams per square meter (mg/m^2) every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423927|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423928|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423929|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423930|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423931|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423932|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423933|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423934|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423935|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423936|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423937|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423938|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423939|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
424029|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
424030|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
424031|NCT00555997|O4|Outcome|Placebo Phase II|Results from phase II for those taking placebo during that phase
424032|NCT00555997|O3|Outcome|Ziprasidone Phase II|Results from phase II for those taking ziprasidone during that phase
423940|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423941|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423942|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423943|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423944|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423945|NCT00556322|O2|Outcome|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day as a tablet until disease progression, unacceptable toxicity or death.
423946|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423947|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423948|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable t oxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423949|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423950|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423951|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423952|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423953|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423954|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423955|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
424033|NCT00555997|O2|Outcome|Placebo Phase I|Results from phase I for those taking placebo during that phase
424034|NCT00555997|O1|Outcome|Ziprasidone Phase I|Results from phase I for those taking ziprasidone during that phase
424035|NCT00555997|E2|Reported Event|Placebo|Adverse events experienced when taking placebo
424036|NCT00555997|E1|Reported Event|Ziprasidone|Adverse events experienced by subjects while taking ziprasidone
424037|NCT00555906|B4|Baseline|Total|Total of all reporting groups
423956|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423957|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423958|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423959|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423960|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel l75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423961|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423962|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423963|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423964|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423965|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423966|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423967|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423968|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423969|NCT00556322|O2|Outcome|Erlotinib|Participants received erlotinib, 150 mg, administered orally as a tablet, once daily until disease progression, unacceptable toxicity, or death.
423970|NCT00556322|O1|Outcome|Comparator|Participants received either pemetrexed 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or docetaxel 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, docetaxel was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423971|NCT00556322|E2|Reported Event|Erlotinib|Participants received a single oral dose of erlotinib 150 mg/day until disease progression, unacceptable toxicity or death.
424114|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424115|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424116|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424117|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424118|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
423972|NCT00556322|E1|Reported Event|Comparator|Participants received either Alimta 500 mg/m^2 every 21 days until disease progression, unacceptable toxicity or death or Taxotere 75 mg/m^2 every 3 weeks until disease progression, unacceptable toxicity or death. Choice of comparator was left to the discretion of the investigator in countries where both treatments are registered to use and are commercially available for second line use (otherwise, Taxotere was administered), assigning the participant to either comparator depending upon the medical needs of the participant. Participants were required to receive concomitant treatment therapy as indicated in the product label.
423973|NCT00556166|B1|Baseline|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
423974|NCT00556166|P1|Participant Flow|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
423975|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
423976|NCT00556166|O1|Outcome|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
423977|NCT00556166|E1|Reported Event|Enterra Therapy|The Enterra Therapy Gastric Stimulator will be used on subjects who have failed all other medical options to treat gastroparesis and all have a gastric stimulator implanted.
423978|NCT00556140|B1|Baseline|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
423979|NCT00556140|P1|Participant Flow|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
423980|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
423981|NCT00556140|O1|Outcome|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
423982|NCT00556140|E1|Reported Event|Major Depression With Psychotic Features|All patients received aripiprazole 10 milligrams and escitalopram 10 milligrams as starting doses. These doses were increased to 20 milligrams and 30 milligrams, respectively. These increases occurred over a period of 7 weeks.
423983|NCT00556075|B4|Baseline|Total|Total of all reporting groups
423984|NCT00556075|B3|Baseline|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
423985|NCT00556075|B2|Baseline|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
423986|NCT00556075|B1|Baseline|Placebo|Placebo: 1 capsule daily for 4 months
423987|NCT00556075|P3|Participant Flow|B 50 mg|Proellex 50 mg: 2 capsules daily for 4 months
423988|NCT00556075|P2|Participant Flow|A 25 mg|Proellex 25 mg: 1 capsule daily for 4 months
423989|NCT00556075|P1|Participant Flow|C Placebo|Placebo: 1 capsule daily for 4 months
423990|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
423991|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
423992|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
423993|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
423994|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
423995|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
423996|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
423997|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
423998|NCT00556075|O1|Outcome|Placebo|"Placebo~Placebo: 1 capsule daily for 4 months"
423999|NCT00556075|O3|Outcome|50 mg|"Proellex 50 mg~Proellex 50 mg: 2 capsules daily for 4 months"
424000|NCT00556075|O2|Outcome|25 mg|"Proellex 25 mg~Proellex 25 mg: 1 capsule daily for 4 months"
424001|NCT00556075|O1|Outcome|Placebo|Placebo: 1capsule daily for 4 months
424002|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
424003|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
424004|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
424005|NCT00556075|O3|Outcome|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
424006|NCT00556075|O2|Outcome|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
424007|NCT00556075|O1|Outcome|Placebo|Placebo: 1 capsule daily for 4 months
424008|NCT00556075|E3|Reported Event|50 mg|Proellex 50 mg: 2 capsules daily for 4 months
424009|NCT00556075|E2|Reported Event|25 mg|Proellex 25 mg: 1 capsule daily for 4 months
424010|NCT00556075|E1|Reported Event|Placebo|Placebo: 1 capsule daily for 4 months
424011|NCT00556049|B1|Baseline|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
424012|NCT00556049|P1|Participant Flow|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
424013|NCT00556049|O1|Outcome|Treatment|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
424014|NCT00556049|E1|Reported Event|Neutropenia|"Sunitinib and gemcitabine~Gemcitabine: Intravenously on days 1 and 8 of each 21-day treatment cycle.~Sunitinib: Orally on days 1-14 of each 21-day treatment cycle"
424015|NCT00555997|B4|Baseline|Total|Total of all reporting groups
424016|NCT00555997|B3|Baseline|Ziprasidone|Subjects received ziprasidone throughout study
424017|NCT00555997|B2|Baseline|Placebo|Subjects received placebo throughout study
424038|NCT00555906|B3|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase2:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424039|NCT00555906|B2|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule B)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424040|NCT00555906|B1|Baseline|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424041|NCT00555906|P5|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424042|NCT00555906|P4|Participant Flow|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424043|NCT00555906|P3|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424044|NCT00555906|P2|Participant Flow|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424119|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424120|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424121|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424122|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424123|NCT00555880|E2|Reported Event|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl (10-30mg) the next day.
424045|NCT00555906|P1|Participant Flow|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 milligram (mg) capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 milligram per square meter (mg/m^2) intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424046|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424047|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424048|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424049|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424050|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424051|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424084|NCT00555893|E1|Reported Event|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
424085|NCT00555880|B3|Baseline|Total|Total of all reporting groups
424052|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424053|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424054|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424055|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424056|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424057|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424058|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424086|NCT00555880|B2|Baseline|Placebo/Midodrine|Participants received matching Placebo followed by a single oral dose of Midodrine HCl the next day
424087|NCT00555880|B1|Baseline|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl followed by matching Placebo the next day
424088|NCT00555880|P2|Participant Flow|Placebo/Midodrine|Participants received Placebo followed by a single oral dose of Midodrine HCl the next day
424089|NCT00555880|P1|Participant Flow|Midodrine/Placebo|Participants received a single oral dose of Midodrine hydrochloride (HCl) followed by matching Placebo the next day
424090|NCT00555880|O1|Outcome|All Participants|All randomized participants
424059|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424060|NCT00555906|O4|Outcome|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424061|NCT00555906|O3|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424062|NCT00555906|O2|Outcome|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424063|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424064|NCT00555906|O1|Outcome|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424065|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424091|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424092|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424093|NCT00555880|O1|Outcome|All Participants|All randomized participants
424094|NCT00555880|O1|Outcome|All Participants|All randomized participants
424095|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424096|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424920|NCT00554216|P3|Participant Flow|VI-0521 Top|PHEN/TPM 15 mg/92 mg
424066|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424067|NCT00555906|O2|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:ScheduleB)|Included all participants who received palbociclib (PD 0332991) 100 mg or 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424068|NCT00555906|O1|Outcome|Palbociclib + Bortezomib + Dexamethasone (Phase1:Schedule A)|Included all participants who received palbociclib (PD 0332991) 75 mg or 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424069|NCT00555906|E5|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase2:ScheduleB)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 2 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424070|NCT00555906|E4|Reported Event|Palbociclib 125mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 125 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424071|NCT00555906|E3|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule B)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 12 days followed by 9 days off-treatment in a 21-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 21-day cycle (schedule B) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424072|NCT00555906|E2|Reported Event|Palbociclib 75mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 75 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424097|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424098|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424099|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424100|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424101|NCT00555880|O2|Outcome|Placebo|Placebo: A daily dose of Placebo tablets matching Midodrine HCl in appearance and number
424073|NCT00555906|E1|Reported Event|Palbociclib 100mg+Bortezomib+Dexamethasone(Phase1:Schedule A)|Palbociclib (PD 0332991) 100 mg capsule orally once daily for 21 days followed by 7 days off-treatment in a 28-day cycle along with bortezomib 1.0 mg/m^2 intravenous injection and dexamethasone 20 mg tablet orally 30 minutes prior to bortezomib injection on Day 8, 11, 15 and 18 of 28-day cycle (schedule A) during Phase 1 of the study. Treatment was continued until any of the following withdrawal criteria was met: disease progression (unless the investigator judged that participant could still derive clinical benefit from continuing the treatment and the risk/benefit was still favorable), unacceptable toxicities, need for surgery or radiation therapy considered due to progressive disease by investigator, investigator conclusion that it is in the participant's best interest to discontinue therapy, need for anti-cancer therapy, lost to follow-up, withdrawal from treatment, or withdrawal of consent.
424074|NCT00555893|B3|Baseline|Total|Total of all reporting groups
424075|NCT00555893|B2|Baseline|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
424076|NCT00555893|B1|Baseline|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
424077|NCT00555893|P2|Participant Flow|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
424078|NCT00555893|P1|Participant Flow|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
424079|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
424080|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
424081|NCT00555893|O2|Outcome|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
424082|NCT00555893|O1|Outcome|Active Drug|"Adults and adolescents weighing greater than 88 pounds will receive one 75 mg oseltamivir capsule twice daily, with or without food for a total of 5 days (10 doses). Participants one year of age and older up to a maximum weight of 88 pounds will receive a liquid form of study medication containing oseltamivir at a concentration of 15mg/ml. The dose will be based on weight:~for weight <=33 lbs, dose=30 mg, volume per dose (15mg/mL)=2 mL two times per day x 5 days (10 doses); for weight 34-51 lbs, dose=45 mg, volume per dose (15mg/mL)=3 mL two times per day x 5 days (10 doses); for weight 52-88 lbs, dose=60 mg, volume per dose (15mg/mL)= 4 mL two times per day x 5 days (10 doses)"
424083|NCT00555893|E2|Reported Event|Placebo|"Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day.~Placebo: Identical placebo capsule twice daily for 5 days (10 doses). Participants one year of age and older up to a maximum of 88 pounds will receive a placebo syrup. The dose will be based on weight as follows: <=33 pounds,2 mL doses, two times per day; 34 - 51 pounds, 3 mL doses, two times per day; 52-88 pounds, 4 mL doses, two times per day."
424102|NCT00555880|O1|Outcome|Midodrine HCl|Midodrine HCl: one dose, 10-30mg, given orally
424124|NCT00555880|E1|Reported Event|Midodrine/Placebo|Participants received a single oral dose of Midodrine HCl (10-30mg) followed by placebo the next day.
424125|NCT00555750|B3|Baseline|Total|Total of all reporting groups
424126|NCT00555750|B2|Baseline|Placebo|nightly administration of placebo before bed
424127|NCT00555750|B1|Baseline|Active|active medication administration nightly before bed
424128|NCT00555750|P2|Participant Flow|Placebo|nightly placebo (identical tablet to active medication) oral administration ~30 min before bed
424129|NCT00555750|P1|Participant Flow|Eszopiclone|nightly active medication (eszopiclone, 3 mg tablet) oral administration ~30 min before bed
424130|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424131|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424132|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424133|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424134|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424135|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424136|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424137|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424138|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424139|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424140|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424141|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424142|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424143|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424144|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424145|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424146|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424147|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424148|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424149|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424150|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424151|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424152|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424153|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424154|NCT00555750|O2|Outcome|Placebo|nightly administration of placebo before bed
424155|NCT00555750|O1|Outcome|Active|active medication administration nightly before bed
424156|NCT00555750|E2|Reported Event|Placebo|nightly administration of placebo before bed
424157|NCT00555750|E1|Reported Event|Active|active medication administration nightly before bed
424158|NCT00555672|B3|Baseline|Total|Total of all reporting groups
424159|NCT00555672|B2|Baseline|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424160|NCT00555672|B1|Baseline|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424161|NCT00555672|P2|Participant Flow|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424162|NCT00555672|P1|Participant Flow|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424163|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424164|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424165|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424166|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424167|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424168|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424169|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424170|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424171|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424172|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424173|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424174|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424175|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424176|NCT00555672|O2|Outcome|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424177|NCT00555672|O1|Outcome|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424178|NCT00555672|E2|Reported Event|Sunitinib (37.5 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 37.5 mg oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424179|NCT00555672|E1|Reported Event|Sunitinib (25 mg) in Combination With Cisplatin and 5-FU|Sunitinib: 25 milligram (mg) oral capsule daily for 2 weeks (Day 1 to 14) followed by 1 week (Day 15 to 21) off treatment. Cisplatin: 80 mg per meter squared (mg/m^2) intravenous on Day 1 of each 21-day cycle. 5-Fluorouracil (5-FU): 4000 mg/m^2 continuous infusion for 96 hours starting Day 1 and ending Day 5 of each 21-day cycle.
424180|NCT00555620|B7|Baseline|Total|Total of all reporting groups
424181|NCT00555620|B6|Baseline|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424182|NCT00555620|B5|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424183|NCT00555620|B4|Baseline|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424184|NCT00555620|B3|Baseline|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424185|NCT00555620|B2|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424186|NCT00555620|B1|Baseline|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424187|NCT00555620|P6|Participant Flow|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424188|NCT00555620|P5|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424189|NCT00555620|P4|Participant Flow|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424190|NCT00555620|P3|Participant Flow|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424191|NCT00555620|P2|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424192|NCT00555620|P1|Participant Flow|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424193|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424194|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424195|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424196|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424197|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424198|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424199|NCT00555620|O5|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424200|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424201|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424202|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424203|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424204|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424205|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424206|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424207|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424208|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424209|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424210|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424211|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424212|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424213|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424214|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424215|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424216|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424217|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424218|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424219|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424220|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424221|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424222|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424223|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424224|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424225|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424226|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424227|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424228|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424229|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424230|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424231|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424232|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424233|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424234|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424235|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424236|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424237|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424238|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424239|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424240|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424241|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424242|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424243|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424244|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424245|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424246|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424247|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424719|NCT00555152|P1|Participant Flow|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424248|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424249|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424250|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424251|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424252|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424253|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424254|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424255|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424256|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424257|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424258|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424259|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424260|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424261|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424262|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424263|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424264|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424265|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424266|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424267|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424268|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424269|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424270|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424271|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424272|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424273|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424274|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424275|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424276|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424277|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424720|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424278|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424279|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424280|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424281|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424282|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424283|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424284|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424285|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424286|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424287|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424288|NCT00555620|O3|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424289|NCT00555620|O2|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424290|NCT00555620|O1|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424291|NCT00555620|O6|Outcome|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424292|NCT00555620|O5|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424293|NCT00555620|O4|Outcome|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424294|NCT00555620|O3|Outcome|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424295|NCT00555620|O2|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424296|NCT00555620|O1|Outcome|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424297|NCT00555620|E6|Reported Event|SU 25 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424298|NCT00555620|E5|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. OXA: 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424299|NCT00555620|E4|Reported Event|SU 37.5 mg, OXA 110 mg/m^2, CAP 1600 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. Oxaliplatin (OXA): 110 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 800 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424300|NCT00555620|E3|Reported Event|SU 25 mg, CIS 80 mg/m^2, CAP 2000 mg/m^2|SU: 25 mg oral capsule Schedule 2/1. CIS: 80 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424301|NCT00555620|E2|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 2000 mg/m^2|SU: 37.5 mg oral capsule Schedule 2/1. CIS: 60 mg/m^2 IV on Day 1 of each 21-day cycle. CAP: 1000 mg/m^2 oral tablets BID on Days 1-14 of each 21-day cycle.
424302|NCT00555620|E1|Reported Event|SU 37.5 mg, CIS 60 mg/m^2, CAP 1600 mg/m^2|Sunitinib (SU): 37.5 milligram (mg) oral capsule daily for 2 weeks (14 days) followed by 1 week (7 days) off treatment (Schedule 2/1). Cisplatin (CIS): 60 mg per meter squared (mg/m^2) intravenous (IV) on Day 1 of each 21-day cycle. Capecitabine (CAP): 800 mg/m^2 oral tablets twice-a-day (BID) on Days 1-14 of each 21-day cycle.
424303|NCT00555568|B4|Baseline|Total|Total of all reporting groups
424304|NCT00555568|B3|Baseline|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424305|NCT00555568|B2|Baseline|Arm 2: Clinician-Led Group|"Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician~recovery-oriented mental health clinician-led group: This is a recovery-focused mental health education and support group led by a mental health clinician"
424306|NCT00555568|B1|Baseline|Arm 1: Peer-Led Group|"Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators~recovery oriented mental health peer support group: This is a recovery-focused mental health education and support group led by peer facilitators"
424307|NCT00555568|P3|Participant Flow|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424921|NCT00554216|P2|Participant Flow|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
424308|NCT00555568|P2|Participant Flow|Arm 2: Clinician Led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424309|NCT00555568|P1|Participant Flow|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424310|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424311|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424312|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424313|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424314|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424315|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424316|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424317|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424318|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424319|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424320|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424321|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424322|NCT00555568|O3|Outcome|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424323|NCT00555568|O2|Outcome|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424324|NCT00555568|O1|Outcome|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424325|NCT00555568|E3|Reported Event|Arm 3: Treatment as Usual|Arm 3 is treatment as usual (no intervention)
424326|NCT00555568|E2|Reported Event|Arm 2: Clinician-led Group|Arm 2 is a 3-month recovery-focused mental health education and support group led by a mental health clinician
424327|NCT00555568|E1|Reported Event|Arm 1: Peer-led Group|Arm 1 is a 3-month recovery-focused mental health education and support group led by peer facilitators
424328|NCT00555477|B3|Baseline|Total|Total of all reporting groups
424329|NCT00555477|B2|Baseline|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
424330|NCT00555477|B1|Baseline|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
424331|NCT00555477|P2|Participant Flow|Anastrozole Part 2|During the conduct of the trial the study was amended to change the eligibility criteria because of difficulties with the estradiol assay. Subjects enrolled after the amendment were required to sign consent and then have an average baseline estradiol concentration of ≤20 pg/ml in order to be considered eligible.
424332|NCT00555477|P1|Participant Flow|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH (Follicle-stimulating hormone) concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
424333|NCT00555477|O2|Outcome|Anastrozole Part 2|Analysis of the first 18 subjects enrolled revealed a greater than expected discontinuation of AI therapy because of elevated serum estradiol concentrations. Discontinuation was believed to be primarily due to greater than expected variability in the assay as opposed to true recovery of ovarian function. Therefore, the protocol was amended. Subjects with an average baseline estradiol concentration of ≤20 pg/ml were considered eligible for part 2 and initiated treatment with anastrozole 1 mg orally daily.
424334|NCT00555477|O1|Outcome|Anastrozole Part 1|In the initial version of the clinical trial (designated part 1), subjects were required to have serum estradiol and FSH concentrations within the postmenopausal range according to local institutional guidelines within 28 days of enrollment. Subjects taking tamoxifen at the time of screening were only required to have postmenopausal serum estradiol concentrations. Subjects were treated with anastrozole, 1 mg orally daily.
424335|NCT00555477|E1|Reported Event|Anastrozole|anastrozole: 1 mg tablet by mouth once a day
424336|NCT00555464|B3|Baseline|Total|Total of all reporting groups
424337|NCT00555464|B2|Baseline|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
424356|NCT00555425|B2|Baseline|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424922|NCT00554216|P1|Participant Flow|Placebo|
424338|NCT00555464|B1|Baseline|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
424339|NCT00555464|P2|Participant Flow|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
424340|NCT00555464|P1|Participant Flow|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
424341|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
424342|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
424343|NCT00555464|O2|Outcome|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
424344|NCT00555464|O1|Outcome|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
424345|NCT00555464|E2|Reported Event|Oral Steroid Treatment Group|"The standard treatment for hemangioma at most centers is oral steroids (Prednisolone). Prednisolone has been used to stop the growth of infantile hemangiomas that are life threatening, that could harm important functions, or are likely to result in severe disfigurement (scarring) without treatment.~Prednisone : Prednisolone given at 3 mg/kg/day by mouth for 12 week"
424346|NCT00555464|E1|Reported Event|Vincristine Treatment Group|"Vincristine is a drug that has been used to treat cancers in children (including infants). It has been effective in treating a small number of infants with hemangiomas, most of whom failed previous therapies including steroids. Vincristine must be administered into a vein. Given the encouraging response data and documented safety record, Vincristine is a good choice for a clinical trial treating infants with complicated hemangiomas.~Vincristine : Vincristine (0.05 mg/kg/dose) will be administered into a vein (PICC line) every week for 12 weeks. If assigned to receive Vincristine, a PICC line will be placed by a doctor who is a specialist in this procedure, an interventional radiologist. This will require sedation and when possible, will be coordinated with sedation for the MRI."
424347|NCT00555438|B1|Baseline|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424348|NCT00555438|P1|Participant Flow|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424349|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424350|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424351|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424352|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424353|NCT00555438|O1|Outcome|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424354|NCT00555438|E1|Reported Event|Fondaparinux 1.5 mg/l|patients with renal impairment who received Fondaparinux 1.5 mg/l after major orthopaedic surgery
424355|NCT00555425|B3|Baseline|Total|Total of all reporting groups
424721|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424722|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424357|NCT00555425|B1|Baseline|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424358|NCT00555425|P2|Participant Flow|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424359|NCT00555425|P1|Participant Flow|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424360|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424361|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424362|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424363|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424364|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424365|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424407|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424923|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
424366|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424367|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424368|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424369|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424370|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424371|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424372|NCT00555425|O2|Outcome|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424373|NCT00555425|O1|Outcome|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424374|NCT00555425|E2|Reported Event|Maintenance Condition|"Buprenorphine/naloxone maintenance (Mtn) is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services.~Behavioral: Buprenorphine/naloxone maintenance (Mtn): Mtn is designed to reflect usual care by primary care physicians and includes weekly drug counseling (DC) and referral to ancillary services. Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study."
424404|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424405|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424729|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424375|NCT00555425|E1|Reported Event|Taper Condition|"Buprenorphine/naloxone detoxification (Dtx) is identical to Mtn for the first 4 weeks (stabilization) following randomization. In Mtn, Bup will continue unchanged for the remainder of the study. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Buprenorphine/naloxone.~Behavioral: Buprenorphine/naloxone detoxification (Dtx): Dtx and Mtn will be identical for the first 4 weeks (stabilization) following randomization. In Dtx, the dosage of Bup will be tapered to zero over the next 3 weeks, and patients will not receive additional Bup for the remainder of the study. Dtx patients will be offered thrice-weekly DC beginning during the taper and naltrexone will be offered 7 days following the last dose of Bup."
424376|NCT00555360|B3|Baseline|Total|Total of all reporting groups
424377|NCT00555360|B2|Baseline|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
424378|NCT00555360|B1|Baseline|Standard mHealth|Weekly IVR calls for 12 months
424379|NCT00555360|P2|Participant Flow|mHealth Plus CarePartner|Wkly IVR calls for 12 months+feedback to CarePartner
424380|NCT00555360|P1|Participant Flow|Standard mHealth|Weekly IVR calls for 12 months
424381|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
424382|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
424383|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
424384|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
424385|NCT00555360|O2|Outcome|mHealth+Carepartner|Weekly IVR calls for 12 months+CarePartner feedback
424386|NCT00555360|O1|Outcome|Standard mHealth|Weekly IVR calls for 12 months
424387|NCT00555360|E2|Reported Event|mHealth+Carepartner|Weekly IVR calls for 12 months+feedback to CarePartner
424388|NCT00555360|E1|Reported Event|Standard mHealth|Weekly IVR calls for 12 months
424389|NCT00555321|B6|Baseline|Total|Total of all reporting groups
424390|NCT00555321|B5|Baseline|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424391|NCT00555321|B4|Baseline|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424392|NCT00555321|B3|Baseline|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424393|NCT00555321|B2|Baseline|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424394|NCT00555321|B1|Baseline|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424395|NCT00555321|P5|Participant Flow|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424396|NCT00555321|P4|Participant Flow|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424397|NCT00555321|P3|Participant Flow|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424398|NCT00555321|P2|Participant Flow|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424399|NCT00555321|P1|Participant Flow|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424400|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424401|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424402|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424403|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424406|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424408|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424409|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424410|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424411|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424412|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424413|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424414|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424415|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424416|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424417|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424418|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424419|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424420|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424421|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424422|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424423|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424424|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424425|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424426|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424427|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424428|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424470|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424924|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
424429|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424430|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424431|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424432|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424433|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424434|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424435|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424436|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424437|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424438|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424439|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424440|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424441|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424442|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424443|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424444|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424445|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424446|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424447|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424448|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424471|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424723|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424449|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424450|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424451|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424452|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424453|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424454|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424455|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424456|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424457|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424458|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424459|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424460|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424461|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424462|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424463|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424464|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424465|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424466|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424467|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424468|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424469|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424724|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424472|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424473|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424474|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424475|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424476|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424477|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424478|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424479|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424480|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424481|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424482|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424483|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424484|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424485|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424486|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424487|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424488|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424489|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424490|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424491|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424616|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424492|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424493|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424494|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424495|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424496|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424497|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424498|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424499|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424500|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424501|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424502|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424503|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424504|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424505|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424506|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424507|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424508|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424509|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424510|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424511|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424725|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424925|NCT00554216|O1|Outcome|Placebo|
424512|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424513|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424514|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424515|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424516|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424517|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424518|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424519|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424520|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424521|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424522|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424523|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424524|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424525|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424526|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424527|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424528|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424529|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424530|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424531|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424726|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424532|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424533|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424534|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424535|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424536|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424537|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424538|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424539|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424540|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424541|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424542|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424543|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424544|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424545|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424546|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424547|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424548|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424549|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424550|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE)
424551|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (Short Term [ST]), in accordance with local practice and the package insert, 4 years (LTE) + MMF, IV/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424727|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424552|NCT00555321|O3|Outcome|Group 3: Belatacept Less Intensive (LI) + MMF|Drug: Belatacept Less Intensive (LI), IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424553|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept More Intensive (MI): IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), 5 mg/kg, every 4 weeks, 4 years (LTE) + MMF , Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (ST), ≤ 1 g/day, 4 years (LTE)
424554|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab ; Intravenous (IV), 20 mg, Day 1 and Day 5 Belatacept More Intensive (MI) ; Intravenous (IV), 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF), Intravenous (IV)/Capsules, IV/Oral, 1-2g/day, 52 weeks (Short term [ST]), ≤ 1 g/day, 4 years (Long-term extension [LTE])
424555|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424556|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424557|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424558|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424559|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424560|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424561|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424562|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424563|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424564|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424565|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424566|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424567|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424568|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424569|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424570|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424571|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424572|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424728|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424926|NCT00554216|O3|Outcome|VI-0521 Top|PHEN/TPM 15 mg/92 mg
424573|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424574|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424575|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424576|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424577|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424578|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424579|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424580|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424581|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424582|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424583|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424584|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424585|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424586|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424587|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424588|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424589|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424590|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424591|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424592|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424593|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424681|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424594|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424595|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424596|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424597|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424598|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424599|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424600|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424601|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424602|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424603|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424604|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424605|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424606|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424607|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424608|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424609|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424610|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424611|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424612|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424613|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424614|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424615|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424617|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424618|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424619|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424620|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424621|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424622|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424623|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424624|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424625|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424626|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424627|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424628|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424629|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424630|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424631|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424632|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424633|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424634|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424635|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424636|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424637|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424715|NCT00555152|B1|Baseline|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424716|NCT00555152|P4|Participant Flow|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424638|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424639|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424640|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424641|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424642|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424643|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424644|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424645|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424646|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424647|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424648|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424649|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424650|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424651|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424652|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424653|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424654|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424655|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424656|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424657|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424658|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424717|NCT00555152|P3|Participant Flow|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424718|NCT00555152|P2|Participant Flow|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424659|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424660|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424661|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424662|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424663|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424664|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424665|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424666|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424667|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424668|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424669|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424670|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424671|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424672|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424673|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424674|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424675|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424676|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424677|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424678|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424679|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424680|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424682|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424683|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424684|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424685|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424686|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424687|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424688|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424689|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424690|NCT00555321|O5|Outcome|Group 5: Tacrolimus|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, and 4 years (LTE)
424691|NCT00555321|O4|Outcome|Group 4: Tacrolimus + MMF|Tacrolimus, Capsules, Oral, 6-12 ng/mL trough level, twice daily, 52 weeks (ST), in accordance with local practice and the package insert, 4 years (LTE); MMF, IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424692|NCT00555321|O3|Outcome|Group 3: Belatacept (LI) + MMF|Belatacept Less Intensive (LI)- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 8 and 12. After 3 months (12 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST]), 5 mg/kg, every 4 weeks, 4 years (LTE); MMF, Intravenous (IV)/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), ≤ 1 g/Day, 4 years (LTE)
424693|NCT00555321|O2|Outcome|Group 2: Belatacept (MI) + MMF|Belatacept MI- IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20, and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (ST), and 5 mg/kg, every 4 weeks, 4 years (LTE); MMF-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424694|NCT00555321|O1|Outcome|Group 1: Basiliximab+Belatacept (MI) + MMF|Basiliximab- Intravenous (IV), 20 mg, on Day 1 and Day 5; Belatacept More Intensive (MI)-IV, 10 mg/kg on Days 1, 3 and 5, and at Weeks 2, 4, 6, 8, 10, 12, 16, 20 and 24. After 6 months (24 weeks) 5 mg/kg, every 4 weeks, 52 weeks (Short term [ST]), and 5 mg/kg, every 4 weeks, 4 years (Long-term extension [LTE]); Mycophenolate Mofetil (MMF)-IV/Capsules, IV/Oral, 1-2g/Day, 52 weeks (ST), and ≤ 1 g/Day, 4 years (LTE)
424695|NCT00555321|E5|Reported Event|Tacrolimus + MMF|
424696|NCT00555321|E4|Reported Event|Tacrolimus|
424697|NCT00555321|E3|Reported Event|Belaticept (LI) + MMF|
424698|NCT00555321|E2|Reported Event|MI+MMF|
424699|NCT00555321|E1|Reported Event|Basiliximab+Belatacept (MI)+Mycophenolate Mofetil (MMF)|
424700|NCT00555217|B3|Baseline|Total|Total of all reporting groups
424701|NCT00555217|B2|Baseline|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
424702|NCT00555217|B1|Baseline|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
424703|NCT00555217|P2|Participant Flow|Monotherapy ARB|"Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day"
424704|NCT00555217|P1|Participant Flow|Combination of ARB and ACEI|"Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)~losartan: 50 or 100mg/day~lisinopril: 10, 20 or 40 mg/day"
424705|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
424706|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
424707|NCT00555217|O2|Outcome|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
424708|NCT00555217|O1|Outcome|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
424709|NCT00555217|E2|Reported Event|Monotherapy ARB|Mono therapy arm. Standard treatment with angiotensin receptor blocker (ARB)
424710|NCT00555217|E1|Reported Event|Combination of ARB and ACEI|Combination of an angiotensin converting enzyme inhibitor (ACEI) with an angiotensin receptor blocker (ARB)
424711|NCT00555152|B5|Baseline|Total|Total of all reporting groups
424712|NCT00555152|B4|Baseline|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424713|NCT00555152|B3|Baseline|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424714|NCT00555152|B2|Baseline|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424927|NCT00554216|O2|Outcome|VI-0521 Low|PHEN/TPM 3.75 mg/23 mg
424730|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424731|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424732|NCT00555152|O4|Outcome|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424733|NCT00555152|O3|Outcome|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424734|NCT00555152|O2|Outcome|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424735|NCT00555152|O1|Outcome|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424736|NCT00555152|E4|Reported Event|Arm IV Placebo|Placebo orally once daily for 2-6 weeks until the time of surgery.
424737|NCT00555152|E3|Reported Event|Arm III Lapatinib 750 mg|Lapatinib 750 mg orally once daily for 2-6 weeks until the time of surgery.
424738|NCT00555152|E2|Reported Event|Arm II Lapatinib 1000 mg|Lapatinib 1000 mg orally once daily for 2-6 weeks until the time of surgery.
424739|NCT00555152|E1|Reported Event|Arm I Lapatinib 1500 mg|Lapatinib ditosylate 1500 mg orally once daily for 2-6 weeks until the time of surgery.
424740|NCT00555061|B1|Baseline|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424741|NCT00555061|P1|Participant Flow|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424742|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424743|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424744|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424745|NCT00555061|O1|Outcome|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424746|NCT00555061|E1|Reported Event|Retapamulin Ointment, 1%|Retapamulin ointment, 1%, administered twice daily for 5 consecutive days
424747|NCT00555009|B3|Baseline|Total|Total of all reporting groups
424748|NCT00555009|B2|Baseline|Placebo|Matching placebo injected SC.
424749|NCT00555009|B1|Baseline|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424750|NCT00555009|P2|Participant Flow|Placebo|Matching placebo injected SC.
424751|NCT00555009|P1|Participant Flow|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424752|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424753|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424754|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424755|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424756|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424757|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424758|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424759|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424760|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424761|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424762|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424763|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424764|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424765|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424766|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424767|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424768|NCT00555009|O2|Outcome|Placebo|Matching placebo injected SC.
424769|NCT00555009|O1|Outcome|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424770|NCT00555009|E2|Reported Event|Placebo|Matching placebo injected SC.
424771|NCT00555009|E1|Reported Event|Genotropin|Initiated at 0.2 mg/day subcutaneously (SC) in men and 0.3 mg/day SC in women. Dose adapted monthly in 0.1 or 0.2 mg increments until stabilized in upper half of normal range.
424772|NCT00554996|B1|Baseline|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
424773|NCT00554996|P1|Participant Flow|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
424774|NCT00554996|O1|Outcome|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
424775|NCT00554996|E1|Reported Event|E. Coli 83972 Coated Urinary Catheter|E. coli 83972 coated urinary catheter: E. coli 83972 coated urinary catheter
424776|NCT00554970|B5|Baseline|Total|Total of all reporting groups
424808|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424928|NCT00554216|O1|Outcome|Placebo|
424777|NCT00554970|B4|Baseline|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424778|NCT00554970|B3|Baseline|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424779|NCT00554970|B2|Baseline|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424780|NCT00554970|B1|Baseline|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424781|NCT00554970|P4|Participant Flow|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424782|NCT00554970|P3|Participant Flow|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424783|NCT00554970|P2|Participant Flow|Treatment 2 Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424784|NCT00554970|P1|Participant Flow|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424785|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424786|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424787|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424788|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424789|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424790|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424791|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424792|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424793|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424794|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424795|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424796|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424797|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424798|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424799|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424800|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424801|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424802|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424803|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424804|NCT00554970|O1|Outcome|MAP0010 High Dose|a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol
424805|NCT00554970|O4|Outcome|Pulmicort Respules® 0.25 mg|a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol
424806|NCT00554970|O3|Outcome|MAP0010 Low Dose|a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol
424807|NCT00554970|O2|Outcome|Pulmicort Respules® 0.50 mg|a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol
424899|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
424809|NCT00554970|E4|Reported Event|Treatment 4 Then Treatment 3|Subjects received Treatment 4 in period 1 followed by a 7 day washout period and then Treatment 3 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424810|NCT00554970|E3|Reported Event|Treatment 3 Then Treatment 4|Subjects received Treatment 3 in period 1 followed by a 7 day washout period and then Treatment 4 in period 2. Treatment 3 was a single dose of MAP0010 high dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 4 was a single dose of Pulmicort Respules® 0.5mg dose delivered by nebulization twice daily for 7 days as per protocol.
424811|NCT00554970|E2|Reported Event|Treatment 2, Then Treatment 1|Subjects received Treatment 2 in period 1 followed by a 7 day washout period and then Treatment 1 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424812|NCT00554970|E1|Reported Event|Treatment 1 Then Treatment 2|Subjects received Treatment 1 in period 1 followed by a 7 day washout period and then Treatment 2 in period 2. Treatment 1 was a single dose of MAP0010 low dose delivered by nebulization twice daily for 7 days as per protocol. Treatment 2 was a single dose of Pulmicort Respules® 0.25mg dose delivered by nebulization twice daily for 7 days as per protocol.
424813|NCT00554853|B3|Baseline|Total|Total of all reporting groups
424814|NCT00554853|B2|Baseline|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to pioglitazone for 3 months, crossover after a 2 month washout.
424815|NCT00554853|B1|Baseline|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone for 3 months compared to placebo for 3 months,crossover after a 2 month washout.
424816|NCT00554853|P2|Participant Flow|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) for 3 months.
424817|NCT00554853|P1|Participant Flow|Study Drug (Pioglitazone) Then Placebo|Oral daily pioglitazone (study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
424818|NCT00554853|O2|Outcome|All Participants While on Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
424819|NCT00554853|O1|Outcome|All Participants While on Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
424820|NCT00554853|O2|Outcome|Placebo Then Study Drug (Pioglitazone)|Oral daily placebo for 3 months compared to study drug (pioglitazone) for 3 months, crossover after a 2 month washout.
424821|NCT00554853|O1|Outcome|Study Drug (Pioglitazone) Then Placebo|Oral daily study drug (pioglitazone) for 3 months compared to placebo for 3 months, crossover after a 2 month washout.
424822|NCT00554853|E6|Reported Event|Placebo Then Study Drug (Piolglitazone) While on Study Drug|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
424823|NCT00554853|E5|Reported Event|Placebo Then Study Drug (Pioglitazone) During Washout|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
424824|NCT00554853|E4|Reported Event|Placebo Then Study Drug (Pioglitazone) While on Placebo|Oral daily placebo for 3 months, followed by 2 month wash out period, then crossover to study drug (pioglitazone) 45 mg daily for 3 months.
424825|NCT00554853|E3|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Placebo|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
424826|NCT00554853|E2|Reported Event|Study Drug (Pioglitazone) Then Placebo, During Washout|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
424827|NCT00554853|E1|Reported Event|Study Drug (Pioglitazone) Then Placebo, While on Drug|Oral daily pioglitazone 45 mg daily(study drug for 3 months, followed by 2 month wash out period, then crossover to placebo for 3 months.
424828|NCT00554801|B3|Baseline|Total|Total of all reporting groups
424829|NCT00554801|B2|Baseline|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
424830|NCT00554801|B1|Baseline|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
424831|NCT00554801|P2|Participant Flow|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
424832|NCT00554801|P1|Participant Flow|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
424833|NCT00554801|O2|Outcome|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
424834|NCT00554801|O1|Outcome|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
424900|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
424835|NCT00554801|E2|Reported Event|Control Group|No exposure to high-intensity blast; matched to blast-exposed group on gender, age, and hearinig loss
424836|NCT00554801|E1|Reported Event|Blast-exposed|"The study group includes soldiers who have recently been exposed to a high-explosive blast while stationed in Iraq or Afghanistan. They will be recruited at Walter Reed Army Medical Center, Washington, DC.~Audiological testing: Subjects will take part in a battery of audiological tests meant to evaluate the function and status of the auditory system. These tests are similar to the kinds of testing carried out routinely in audiology clinics, and include behavioral tests of pure tone hearing, speech perception, and central auditory function, and electrophysiological testing of the middle ear and of the central auditory system."
424837|NCT00554749|B1|Baseline|Behavioral|All participants received identical behavioral treatment with no control group.
424838|NCT00554749|P1|Participant Flow|Behavioral|All participants received identical behavioral treatment with no control group.
424839|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
424840|NCT00554749|O1|Outcome|Behavioral|All participants received identical behavioral treatment with no control group.
424841|NCT00554749|E1|Reported Event|Behavioral|All participants received identical behavioral treatment with no control group.
424842|NCT00554671|B3|Baseline|Total|Total of all reporting groups
424843|NCT00554671|B2|Baseline|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
424844|NCT00554671|B1|Baseline|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
424845|NCT00554671|P2|Participant Flow|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
424846|NCT00554671|P1|Participant Flow|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
424847|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
424848|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
424849|NCT00554671|O2|Outcome|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
424850|NCT00554671|O1|Outcome|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
424851|NCT00554671|E2|Reported Event|Usual Care|Patients continued on usual care without pharmacist-led group medical visits
424852|NCT00554671|E1|Reported Event|Pharmacist-led Group Medical Visits|"Pharmacist-led group medical visits which consists of medication titration and behavioral modification~Algorithm driven medication titration: Clinical pharmacists will change medications to achieve goals in hypertension, dyslipidemia and diabetes~Monitoring: Clinical pharmacists will monitor the progress of patients in lifestyle modification and cardiac risk factor control goals~Group support: Peer support are provided in the group setting~Self efficacy: Patients are taught with self-monitoring skills for diabetes and blood pressure, as well as healthy cooking and practiced under supervision"
424853|NCT00554619|B1|Baseline|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424854|NCT00554619|P1|Participant Flow|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424855|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424856|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424857|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424858|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424859|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424860|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424861|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424862|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424901|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
424863|NCT00554619|O1|Outcome|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424864|NCT00554619|E1|Reported Event|GSK1325760A|Dose of GSK1325760A could be adjusted up to 10 milligrams, once daily, as appropriate according to a participant's condition.
424865|NCT00554463|B1|Baseline|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
424866|NCT00554463|P1|Participant Flow|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
424867|NCT00554463|O1|Outcome|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
424868|NCT00554463|E1|Reported Event|Combined Modality Therapy With Growth Factor Support|Radiation therapy, concurrent chemotherapy and Filgrastim followed by adjuvant chemotherapy and Pegfilgrastim
424869|NCT00554372|B3|Baseline|Total|Total of all reporting groups
424870|NCT00554372|B2|Baseline|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424871|NCT00554372|B1|Baseline|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424872|NCT00554372|P2|Participant Flow|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424873|NCT00554372|P1|Participant Flow|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424874|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424875|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424876|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424877|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424878|NCT00554372|O2|Outcome|High Dose|"1e9 pfu (plaque-forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
424879|NCT00554372|O1|Outcome|Low Dose|"1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart)~JX-594: Recombinant vaccinia virus (TK-deletion plus GM-CSF): Patients will be randomized 1:1 to one of two total doses (1e8 or 1e9 pfu)and injected intratumorally in 1-5 intrahepatic tumors on Days 1, 15, and 29."
424880|NCT00554372|O2|Outcome|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424881|NCT00554372|O1|Outcome|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424882|NCT00554372|E2|Reported Event|High Dose|1e9 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424883|NCT00554372|E1|Reported Event|Low Dose|1e8 pfu (plaque forming units) total dose of JX-594 (recombinant vaccinia virus) on each of three (3) treatment days (2 weeks apart). Each treatment dose was divided among 1-5 hepatic tumors; all tumors injected at day 1 were also injected at subsequent treatments.
424884|NCT00554294|B3|Baseline|Total|Total of all reporting groups
424885|NCT00554294|B2|Baseline|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
424886|NCT00554294|B1|Baseline|Control Group|Schools did not receive any intervention.
424887|NCT00554294|P2|Participant Flow|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
424888|NCT00554294|P1|Participant Flow|Control Group|Schools did not receive any intervention.
424889|NCT00554294|O2|Outcome|Intervention Group|Schools received water fountains, drinking bottles and lessons as intervention.
424890|NCT00554294|O1|Outcome|Control Group|Schools did not receive any intervention.
424891|NCT00554229|B3|Baseline|Total|Total of all reporting groups
424892|NCT00554229|B2|Baseline|Placebo|Placebo oral tablet once daily
424893|NCT00554229|B1|Baseline|ZD4054|ZD4054 10 mg oral tablet once daily
424894|NCT00554229|P2|Participant Flow|Placebo|Placebo oral tablet once daily
424895|NCT00554229|P1|Participant Flow|ZD4054|ZD4054 10 mg oral tablet once daily
424896|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
424897|NCT00554229|O1|Outcome|ZD4054|ZD4054 10 mg oral tablet once daily
424898|NCT00554229|O2|Outcome|Placebo|Placebo oral tablet once daily
424932|NCT00554190|B1|Baseline|AdvaCoat and Merogel Injectable|AdvaCoat compared with Merogel Injectable
424933|NCT00554190|P1|Participant Flow|AdvaCoat and Merogel|AdvaCoat compared to Merogel Injectable. Subjects were randomized to receive AdvaCoat applied to the right or left middle meatus tissues and Merogel applied to the middle meatus tissues on the opposite side.
424934|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
424935|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
424936|NCT00554190|O2|Outcome|AdvaCoat Sinus Gel|AdvaCoat compared to MeroGel Injectable
424937|NCT00554190|O1|Outcome|Merogel Injectable|Merogel Injectable compared to AdvaCoat
424938|NCT00554099|B4|Baseline|Total|Total of all reporting groups
424939|NCT00554099|B3|Baseline|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424940|NCT00554099|B2|Baseline|Mesalamine|400 mg mesalamine (6 tablets daily)
424941|NCT00554099|B1|Baseline|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424942|NCT00554099|P3|Participant Flow|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424943|NCT00554099|P2|Participant Flow|Mesalamine|400 mg mesalamine (6 tablets daily)
424944|NCT00554099|P1|Participant Flow|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424945|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424946|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424947|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424948|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424949|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424950|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424951|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424952|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424953|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424954|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424955|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424956|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424957|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424958|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424959|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424960|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424961|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424962|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424963|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424964|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424965|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424966|NCT00554099|O3|Outcome|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424967|NCT00554099|O2|Outcome|Mesalamine|400 mg mesalamine (6 tablets daily)
424968|NCT00554099|O1|Outcome|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424969|NCT00554099|E3|Reported Event|Mesalamine & Probiotic|400 mg mesalamine (6 tablets daily) plus Align (1 capsule daily)
424970|NCT00554099|E2|Reported Event|Mesalamine|400 mg mesalamine (6 tablets daily)
424971|NCT00554099|E1|Reported Event|Placebo|Placebo tablets (matching mesalamine, 6 tablets daily)
424972|NCT00553969|B5|Baseline|Total|Total of all reporting groups
424973|NCT00553969|B4|Baseline|4 Placebo + Placebo|
424974|NCT00553969|B3|Baseline|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424975|NCT00553969|B2|Baseline|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
424976|NCT00553969|B1|Baseline|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424977|NCT00553969|P4|Participant Flow|4 Placebo + Placebo|
424978|NCT00553969|P3|Participant Flow|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424979|NCT00553969|P2|Participant Flow|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
424980|NCT00553969|P1|Participant Flow|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424981|NCT00553969|O4|Outcome|4 Placebo + Placebo|
424982|NCT00553969|O3|Outcome|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424983|NCT00553969|O2|Outcome|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
424984|NCT00553969|O1|Outcome|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424985|NCT00553969|E4|Reported Event|4 Placebo + Placebo|
424986|NCT00553969|E3|Reported Event|3 Lisinopril + Placebo|"lisinopril + placebo~lisinopril : tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
425355|NCT00553319|E2|Reported Event|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
424987|NCT00553969|E2|Reported Event|2 Coreg CR + Placebo|"Coreg CR + placebo~carvedilol phosphate : Extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months"
424988|NCT00553969|E1|Reported Event|1 Coreg CR + Lisinopril|"Coreg CR + lisinopril~carvedilol phosphate and lisinopril : carvedilol phosphate = extended release capsules, 20mg once daily for 1 month, 40mg once daily for 8 months; lisinopril= tablets, 10mg once daily for 1 month, 20mg once daily for 8 months"
424989|NCT00553839|B1|Baseline|Ketamine|"Then a 2 mg/kg IV bolus of Ketamine hydrochloride will be given.~ketamine hydrochloride: Open label pharmacokinetic study to be conducted in infants and children presenting for medical procedures (eg., surgery or cardiac catheterization). After the start of the procedure, a 0.5 cc preload blood sample (T0) will be drawn from an IV line. Then a 2 mg/kg IV bolus of Ketamine will be administered over 5 minutes. Timed 0.5 ml blood samples will be drawn at the following intervals: 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360 and 720 minutes after bolus."
424990|NCT00553839|P1|Participant Flow|Single Group Assignment|
424991|NCT00553839|O1|Outcome|Single Group Assignment|
424992|NCT00553839|O1|Outcome|Single Group Assignment|
424993|NCT00553839|O1|Outcome|Single Group Assignment|
424994|NCT00553839|E1|Reported Event|Single Group Assignment|
424995|NCT00553787|B4|Baseline|Total|Total of all reporting groups
424996|NCT00553787|B3|Baseline|VI-0521 Top|15 mg/92 mg phentermine/topiramate
424997|NCT00553787|B2|Baseline|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
424998|NCT00553787|B1|Baseline|Placebo|
424999|NCT00553787|P3|Participant Flow|VI-0521 Top|15 mg/92 mg phentermine/topiramate
425000|NCT00553787|P2|Participant Flow|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
425001|NCT00553787|P1|Participant Flow|Placebo|
425002|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
425003|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
425004|NCT00553787|O1|Outcome|Placebo|
425005|NCT00553787|O3|Outcome|VI-0521 Top|15 mg/92 mg phentermine/topiramate
425006|NCT00553787|O2|Outcome|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
425007|NCT00553787|O1|Outcome|Placebo|
425008|NCT00553787|E3|Reported Event|VI-0521 Top|15 mg/92 mg phentermine/topiramate
425009|NCT00553787|E2|Reported Event|VI-0521 Mid|7.5 mg/46 mg phentermine/topiramate
425010|NCT00553787|E1|Reported Event|Placebo|
425011|NCT00553696|B5|Baseline|Total|Total of all reporting groups
425012|NCT00553696|B4|Baseline|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425013|NCT00553696|B3|Baseline|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425014|NCT00553696|B2|Baseline|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425015|NCT00553696|B1|Baseline|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425016|NCT00553696|P4|Participant Flow|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425017|NCT00553696|P3|Participant Flow|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425018|NCT00553696|P2|Participant Flow|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425019|NCT00553696|P1|Participant Flow|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425066|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425020|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425021|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425022|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425023|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425024|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425025|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425026|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425027|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425028|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425029|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425030|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425031|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425032|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425033|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425034|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425035|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425036|NCT00553696|O4|Outcome|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425037|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425038|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425039|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425040|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425041|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425042|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425043|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425044|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425045|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425046|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
425067|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425047|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
425048|NCT00553696|O1|Outcome|Sunitinib 25 mg 2/2 + Cisplatin + S-1 (MTD Expansion Cohort)|Subset of Sunitinib 25 mg 2/2 + Cisplatin + S-1 arm consisted of participants who were additionally enrolled after the maximum tolerated dose (MTD) of sunitinib was determined as 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment
425049|NCT00553696|O3|Outcome|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425050|NCT00553696|O2|Outcome|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (Dose Escalation Cohort)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily regimen for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425051|NCT00553696|O1|Outcome|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425052|NCT00553696|E4|Reported Event|Sunitinib 12.5 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 12.5 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off -treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle. One participant who was assigned to the sunitinib 25 mg on CDD treatment group inadvertently took sunitinib 12.5 mg/day throughout the study, therefore this participant was analyzed separately in this group.
425053|NCT00553696|E3|Reported Event|Sunitinib 37.5 mg 2/2 + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 37.5 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425054|NCT00553696|E2|Reported Event|Sunitinib 25 mg 2/2 + S-1 + Cisplatin (All)|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily for 2 weeks followed by 2 weeks off-treatment (Schedule 2/2), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 (dose escalation cohort) or Day 2 (dose expansion cohort) of each 4 week cycle. Dose expansion cohort was added after the maximum tolerated dose (MTD) was determined from the dose limiting toxicity (DLT) evaluation.
425055|NCT00553696|E1|Reported Event|Sunitinib 25 mg CDD + S-1 + Cisplatin|Study drugs were administered at following regimens in repeating 4 week cycles; Sunitinib at dose of 25 mg orally once daily continuously (CDD), S-1 at the starting dose of 80-120 mg/day based on body surface area as a twice daily for 3 weeks followed by 1 week off-treatment, cisplatin was administered once at 60 mg/m^2 on Day 1 of each 4 week cycle.
425056|NCT00553644|B1|Baseline|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
425057|NCT00553644|P1|Participant Flow|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
425058|NCT00553644|O1|Outcome|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|"Patients receive induction therapy comprising bortezomib 1.3mg/m^2 IV over 3-5 seconds on days 1, 4, 8, and 11 and lenalidomide 20 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete or partial response as best response after completion of induction therapy receive maintenance therapy comprising bortezomib 1.3 mg/m^2 IV on days 1 and 8 and lenalidomide 15 mg/day PO once daily on days 1-14. Treatment repeats every 21 days for up to 6 years in the absence of disease progression or unacceptable toxicity.~bortezomib: Given IV~lenalidomide: Given PO"
425059|NCT00553644|E1|Reported Event|Treatment (Antiangiogenesis Therapy, Enzyme Inhibitor Therapy)|lenalidomide: Given PO
425060|NCT00553631|B3|Baseline|Total|Total of all reporting groups
425061|NCT00553631|B2|Baseline|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425062|NCT00553631|B1|Baseline|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425063|NCT00553631|P2|Participant Flow|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425064|NCT00553631|P1|Participant Flow|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 unit per kilogram (U/kg) administered intravenously (IV) every other week for 39 weeks.
425065|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425388|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425068|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425069|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425070|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425071|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425072|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425073|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425074|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425075|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425076|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425077|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425078|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425079|NCT00553631|O2|Outcome|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425080|NCT00553631|O1|Outcome|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425081|NCT00553631|E2|Reported Event|Imiglucerase|Imiglucerase 60 U/kg administered IV every other week for 39 weeks.
425082|NCT00553631|E1|Reported Event|Gene-Activated Human Glucocerebrosidase (GA-GCB)|Velaglucerase alfa 60 U/kg administered IV every other week for 39 weeks.
425083|NCT00553605|B3|Baseline|Total|Total of all reporting groups
425084|NCT00553605|B2|Baseline|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425085|NCT00553605|B1|Baseline|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425086|NCT00553605|P2|Participant Flow|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425087|NCT00553605|P1|Participant Flow|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425088|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425089|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425090|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425091|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425092|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425093|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425094|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425095|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425096|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425097|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425098|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425099|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425100|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425101|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425102|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425103|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425389|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425104|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425105|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425106|NCT00553605|O2|Outcome|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425107|NCT00553605|O1|Outcome|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425108|NCT00553605|E2|Reported Event|Ketoprofen|Single bolus injection of 2 mL solution of placebo matched to parecoxib followed by single dose of ketoprofen 100 mg solution intravenously by slow injection over 20 minutes.
425109|NCT00553605|E1|Reported Event|Parecoxib|Single dose of parecoxib 40 milligram (mg) solution intravenously by bolus injection followed by single dose of 100 milliliter (mL) solution of placebo matched to ketoprofen intravenously by slow injection over 20 minutes.
425110|NCT00553514|B6|Baseline|Total|Total of all reporting groups
425111|NCT00553514|B5|Baseline|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425112|NCT00553514|B4|Baseline|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425113|NCT00553514|B3|Baseline|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425114|NCT00553514|B2|Baseline|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425115|NCT00553514|B1|Baseline|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425116|NCT00553514|P5|Participant Flow|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425117|NCT00553514|P4|Participant Flow|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425118|NCT00553514|P3|Participant Flow|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425119|NCT00553514|P2|Participant Flow|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425356|NCT00553319|E1|Reported Event|Placebo|"Placebo~Placebo: Placebo group"
425120|NCT00553514|P1|Participant Flow|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425121|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425122|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425123|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425124|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425125|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425126|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425127|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425128|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425129|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425130|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425382|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425131|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425132|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425133|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425134|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425135|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425136|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425137|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425138|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425139|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425140|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425141|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425179|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425180|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425383|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425384|NCT00553267|O1|Outcome|Amlodipine 10mg|
425142|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425143|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425144|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425145|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425146|NCT00553514|O5|Outcome|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425147|NCT00553514|O4|Outcome|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425148|NCT00553514|O3|Outcome|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425149|NCT00553514|O2|Outcome|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425150|NCT00553514|O1|Outcome|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425151|NCT00553514|E5|Reported Event|Follitropin Alfa 75 IU|Follitropin alfa (Gonal-f®) 75 IU administered subcutaneously once daily from S1 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425152|NCT00553514|E4|Reported Event|AS900672-Enriched 40 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 40 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425181|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425385|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425153|NCT00553514|E3|Reported Event|AS900672-Enriched 30 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 30 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425154|NCT00553514|E2|Reported Event|AS900672-Enriched 20 Mcg|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 20 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 75 IU subcutaneously starting from S7 up to S14 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, =< 3 follicles with a mean diameter of >=14 mm, and one or two of these follicles with a diameter of >=17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425155|NCT00553514|E1|Reported Event|AS900672-Enriched 10 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 10 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 75 international unit (IU) subcutaneously starting from Stimulation Day 7 (S7) up to Stimulation Day 14 (S14) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG) administration day. When follicular response was adequate (that is, less than or equal to [=<] 3 follicles with a mean diameter of greater than or equal to [>=] 14 millimeter [mm], and one or two of these follicles with a diameter of >= 17 mm), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response received or maximum of 14 days.
425156|NCT00553501|B1|Baseline|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425157|NCT00553501|P1|Participant Flow|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425158|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425159|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425160|NCT00553501|O1|Outcome|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425161|NCT00553501|E1|Reported Event|Epratuzumab Plus Rituximab|"Induction Therapy (Month 1):~Epratuzumab 360 mg/m^2 by IV days 1, 8, 15 & 22; Rituximab 375 mg/m^2 by IV day 3, 8, 15 & 22~Extended Induction (Weeks 12, 20, 28 & 36) Epratuzumab 360 mg/m^2 by IV weeks 12, 20, 28 & 36; Rituximab 375 mg/m^2 by IV weeks 12, 20, 28 & 36"
425162|NCT00553475|B4|Baseline|Total|Total of all reporting groups
425163|NCT00553475|B3|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425164|NCT00553475|B2|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425165|NCT00553475|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425166|NCT00553475|P3|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425167|NCT00553475|P2|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425168|NCT00553475|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425169|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425170|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425171|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425172|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425173|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425174|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425175|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425176|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425177|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425178|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425386|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425182|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425183|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425184|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425185|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425186|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425187|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425188|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425189|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425190|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425191|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425192|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425193|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425194|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425195|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425196|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425197|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425198|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425199|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425200|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425201|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425202|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425203|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425204|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425205|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425206|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425207|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425208|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425209|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425210|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425211|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425212|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425213|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425214|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425215|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425216|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425217|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425218|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425219|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425220|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425221|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425222|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425223|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425224|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425225|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425226|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425227|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425228|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425229|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425230|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425231|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425232|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425233|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425234|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425235|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425236|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425237|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425238|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425239|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425240|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425241|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425242|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425243|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425244|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425245|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425246|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425247|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425248|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425249|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425250|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425251|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425252|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425253|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425254|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425255|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425256|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425257|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425258|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425259|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425260|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425261|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425262|NCT00553475|O3|Outcome|Expected Exposure Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr in the pregabalin 300 and 600 mg/day groups received pregabalin 300 mg/day and subjects with normal CLcr in the pregabalin 600 mg/day group received pregabalin 600 mg/day for 12 weeks.
425263|NCT00553475|O2|Outcome|Expected Exposure Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with normal CLcr in the pregabalin 300 mg/day group received pregabalin 300 mg/day for 12 weeks.
425264|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425265|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425266|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425267|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425268|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425269|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425270|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425271|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425272|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425273|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425274|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425275|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425276|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425277|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425278|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425279|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425280|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425281|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425282|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425283|NCT00553475|O3|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425284|NCT00553475|O2|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425285|NCT00553475|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425286|NCT00553475|E3|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
425287|NCT00553475|E2|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
425288|NCT00553475|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
425289|NCT00553462|B1|Baseline|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425290|NCT00553462|P1|Participant Flow|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425291|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425319|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425387|NCT00553267|O1|Outcome|Amlodipine 10mg|
425292|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425293|NCT00553462|O1|Outcome|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425294|NCT00553462|E1|Reported Event|Paclitaxel + Carboplatin + Radiation + Erlotinib|"Patients receive paclitaxel 100 mg/m^2 IV over 30 minutes on days 1 and 8 and carboplatin AUC=5 IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses.~Beginning on day 43 (week 7), patients receive oral erlotinib hydrochloride 150 mg once daily. Patients also undergo concurrent radiotherapy 200 cGy/day, 5 days a week for up to 7 weeks (33 fractions), total dose of 6600 cGy."
425295|NCT00553436|B1|Baseline|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425296|NCT00553436|P1|Participant Flow|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425297|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425298|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425299|NCT00553436|O1|Outcome|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425300|NCT00553436|E1|Reported Event|Enrolled Subjects Treated With Tissue Apposition System (TAS)|All enrolled subjects treated with Tissue Apposition System (TAS) device and achieving defect closure
425301|NCT00553358|B4|Baseline|Total|Total of all reporting groups
425302|NCT00553358|B3|Baseline|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425303|NCT00553358|B2|Baseline|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425304|NCT00553358|B1|Baseline|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
425305|NCT00553358|P3|Participant Flow|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425306|NCT00553358|P2|Participant Flow|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425307|NCT00553358|P1|Participant Flow|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenously (IV) for an additional 12 weeks
425308|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425309|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425310|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425311|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425312|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425313|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425314|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425315|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425316|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425317|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425318|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425354|NCT00553319|E3|Reported Event|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
425320|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425321|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425322|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425323|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425324|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425325|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425326|NCT00553358|O3|Outcome|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425327|NCT00553358|O2|Outcome|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425328|NCT00553358|O1|Outcome|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425329|NCT00553358|E3|Reported Event|Lapatinib 1000/750 mg + Trastuzumab 2 mg/kg|Oral lapatinib 1000 mg daily plus trastuzumab 4 mg/kg IV load followed by 2 mg/kg IV weekly for 6 weeks, followed by lapatinib 750 mg daily plus trastuzumab (2 mg/kg IV weekly) plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425330|NCT00553358|E2|Reported Event|Trastuzumab 2 mg/kg|Trastuzumab (4 mg/kilograms [kg] IV load followed by 2 mg/kg IV weekly) for 6 weeks, followed by trastuzumab plus weekly paclitaxel (80 mg/m^2 IV) for an additional 12 weeks
425331|NCT00553358|E1|Reported Event|Lapatinib 1500 mg|Oral lapatinib (1500 milligrams [mg] daily) for 6 weeks, followed by lapatinib plus weekly paclitaxel (80 mg per meters squared [mg/m^2]) intravenous (IV) for an additional 12 weeks
425332|NCT00553332|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425333|NCT00553332|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425334|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425335|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425336|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425337|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425338|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425339|NCT00553332|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425340|NCT00553332|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral selumetinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~selumetinib: Given orally~laboratory biomarker analysis: Correlative studies"
425341|NCT00553319|B4|Baseline|Total|Total of all reporting groups
425342|NCT00553319|B3|Baseline|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
425343|NCT00553319|B2|Baseline|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
425344|NCT00553319|B1|Baseline|Placebo|"Placebo~Placebo: Placebo group"
425345|NCT00553319|P3|Participant Flow|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
425346|NCT00553319|P2|Participant Flow|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
425347|NCT00553319|P1|Participant Flow|Placebo|"Placebo~Placebo: Placebo group"
425348|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
425349|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
425350|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
425351|NCT00553319|O3|Outcome|Adderall-XR 80 mg|"Adderall-XR 80 mg~Adderall-XR: Adderall-XR 80mg/day"
425352|NCT00553319|O2|Outcome|Adderall-XR 60 mg|"Adderall-XR 60 mg~Adderall-XR: Adderall-XR 60mg/day"
425353|NCT00553319|O1|Outcome|Placebo|"Placebo~Placebo: Placebo group"
425357|NCT00553280|B1|Baseline|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425358|NCT00553280|P1|Participant Flow|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425359|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425360|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425361|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425362|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425363|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425364|NCT00553280|O1|Outcome|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425365|NCT00553280|E1|Reported Event|Pregabalin|Participants initiated to take the study drug at a dose of 75 mg in the evening of Day 1, and then 150 mg/day (75 mg BID) for 1 week from Day 2. Thereafter, participants continued the treatment with pregabalin for 52 weeks, with the maximum doses of 300 mg/day (150 mg BID) for participants with low CLcr (30 < CLcr ≤ 60 mL/min) and 600 mg/day (300 mg BID) for participants with normal CLcr (CLcr > 60 mL/min). In consideration of safety and the effect on pain, the doses were adjusted by one step (150 mg/day) at each visit. Participants treated with pregabalin at the doses of 300 mg/day or higher ended the treatment after a 1-week dose reduction period.
425366|NCT00553267|B4|Baseline|Total|Total of all reporting groups
425367|NCT00553267|B3|Baseline|Telmisartan 80mg and Amlodipine 10mg|
425368|NCT00553267|B2|Baseline|Telmisartan 40mg and Amlodipine 10mg|
425369|NCT00553267|B1|Baseline|Amlodipine 10mg|
425370|NCT00553267|P3|Participant Flow|Telmisartan 80mg and Amlodipine 10mg|
425371|NCT00553267|P2|Participant Flow|Telmisartan 40mg and Amlodipine 10mg|
425372|NCT00553267|P1|Participant Flow|Amlodipine 10mg|
425373|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425374|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425375|NCT00553267|O1|Outcome|Amlodipine 10mg|
425376|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425377|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425378|NCT00553267|O1|Outcome|Amlodipine 10mg|
425379|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425380|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425381|NCT00553267|O1|Outcome|Amlodipine 10mg|
425390|NCT00553267|O1|Outcome|Amlodipine 10mg|
425391|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425392|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425393|NCT00553267|O1|Outcome|Amlodipine 10mg|
425394|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425395|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425396|NCT00553267|O1|Outcome|Amlodipine 10mg|
425397|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425398|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425399|NCT00553267|O1|Outcome|Amlodipine 10mg|
425400|NCT00553267|O3|Outcome|Telmisartan 80mg and Amlodipine 10mg|
425401|NCT00553267|O2|Outcome|Telmisartan 40mg and Amlodipine 10mg|
425402|NCT00553267|O1|Outcome|Amlodipine 10mg|
425403|NCT00553267|E3|Reported Event|Telmisartan 80mg and Amlodipine 10mg|
425404|NCT00553267|E2|Reported Event|Telmisartan 40mg and Amlodipine 10mg|
425405|NCT00553267|E1|Reported Event|Amlodipine 10mg|
425406|NCT00553150|B3|Baseline|Total|Total of all reporting groups
425407|NCT00553150|B2|Baseline|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425408|NCT00553150|B1|Baseline|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425409|NCT00553150|P2|Participant Flow|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425410|NCT00553150|P1|Participant Flow|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425411|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425412|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425413|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425414|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425415|NCT00553150|O1|Outcome|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425446|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425447|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
425448|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425449|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
425505|NCT00552448|B3|Baseline|Total|Total of all reporting groups
425416|NCT00553150|O3|Outcome|Phase I: Dose Level 2|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425417|NCT00553150|O2|Outcome|Phase I: Dose Level 1|Cycle 1: Everolimus 50 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 50 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425418|NCT00553150|O1|Outcome|Phase I: Dose Level 0|Cycle 1: Everolimus 30 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 30 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425419|NCT00553150|E2|Reported Event|Phase II|Cycle 1: Everolimus 70 mg days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus 70 mg/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425420|NCT00553150|E1|Reported Event|Phase I|Cycle 1: Everolimus (either: 30, 50, or 70 mg) days 1, 8, and weekly through radiation therapy (RT). Starting between day 8 and 15 RT was 60 Gy (2 Gy x 30 fractions) 5 days/week on weekdays for 6 weeks. Temozolomide (TMZ) 75 mg/m2/day starting with, and continuing through, RT. Cycle 2: 4-6 week rest period post RT/TMZ/Everolimus. Cycles 3-8: (28-day cycles): TMZ 150 mg/m2 days 1-5 of cycle 3 and 200 mg/m2 days 1-5 of cycles 4-8. Cycle 3+: Everolimus (either: 30, 50, or 70 mg)/week (Days 1, 8, 15 and 22 for each cycle, until progression). Prophylaxis for pneumocystis carinii pneumonia (PCP) was required starting cycle 1 day1.
425421|NCT00552812|B1|Baseline|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425422|NCT00552812|P1|Participant Flow|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425423|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425424|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425425|NCT00552812|O1|Outcome|Coarctation Stenting|Stent enlargement of aortic coarctation: Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425426|NCT00552812|E1|Reported Event|Coarctation Stenting|Stent enlargement of aortic coarctation : Transcatheter delivery of a metallic stent to enlarge region of aortic narrowing caused by the coarctation.
425427|NCT00552786|B3|Baseline|Total|Total of all reporting groups
425428|NCT00552786|B2|Baseline|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
425429|NCT00552786|B1|Baseline|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
425430|NCT00552786|P2|Participant Flow|Placebo First, Then N-acetylcysteine (NAC)|Placebo in the first intervention period and Formulation NAC in the second intervention period (after washout period).
425431|NCT00552786|P1|Participant Flow|N-acetylcysteine (NAC) First, Then Placebo|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) in the first intervention period and Placebo (a tablet of identical taste and odor to the NAC agent) in the second intervention period (after washout period).
425432|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
425433|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
425434|NCT00552786|O2|Outcome|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
425435|NCT00552786|O1|Outcome|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
425436|NCT00552786|E2|Reported Event|Placebo|Placebo administered once daily in either first intervention period or second intervention period.
425437|NCT00552786|E1|Reported Event|N-acetylcysteine (NAC)|Formulation NAC (1200 mg/day, 14 days) (Actein, Synmosa Corp., Taiwan) administered in either first intervention period or second intervention period.
425438|NCT00552760|B3|Baseline|Total|Total of all reporting groups
425439|NCT00552760|B2|Baseline|Placebo|one tablet at bedtime for up to 6 months
425440|NCT00552760|B1|Baseline|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425441|NCT00552760|P2|Participant Flow|Placebo|one tablet at bedtime for up to 6 months
425442|NCT00552760|P1|Participant Flow|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425443|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
425444|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425445|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
425450|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425451|NCT00552760|O2|Outcome|Placebo|one tablet at bedtime for up to 6 months
425452|NCT00552760|O1|Outcome|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425453|NCT00552760|E2|Reported Event|Placebo|one tablet at bedtime for up to 6 months
425454|NCT00552760|E1|Reported Event|Ramelteon|one 8 mg tablet at bedtime for up to 6 months
425455|NCT00552695|B3|Baseline|Total|Total of all reporting groups
425456|NCT00552695|B2|Baseline|Control Patch|Warm patch with no active substances
425457|NCT00552695|B1|Baseline|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
425458|NCT00552695|P2|Participant Flow|Control Patch|Warm patch with no active substances
425459|NCT00552695|P1|Participant Flow|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
425460|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
425461|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
425462|NCT00552695|O2|Outcome|Control Patch|Warm patch with no active substances
425463|NCT00552695|O1|Outcome|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
425464|NCT00552695|E2|Reported Event|Control Patch|Warm patch with no active substances
425465|NCT00552695|E1|Reported Event|LIDODERM Patch|Lidocaine 70 mg/tetracaine 70 mg skin patch
425466|NCT00552669|B3|Baseline|Total|Total of all reporting groups
425467|NCT00552669|B2|Baseline|Drug Eluting Stents|Any Drug Eluting Stents
425468|NCT00552669|B1|Baseline|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425469|NCT00552669|P2|Participant Flow|Drug Eluting Stents|Any Drug Eluting Stents
425470|NCT00552669|P1|Participant Flow|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425471|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
425472|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425473|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
425474|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425475|NCT00552669|O2|Outcome|Drug Eluting Stents|Any Drug Eluting Stents
425476|NCT00552669|O1|Outcome|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425477|NCT00552669|E2|Reported Event|Drug Eluting Stents|Any Drug Eluting Stents
425478|NCT00552669|E1|Reported Event|Oral Sirolimus + Bare Metal Stent|Oral sirolimus plus bare metal stent implantation
425479|NCT00552578|B3|Baseline|Total|Total of all reporting groups
425480|NCT00552578|B2|Baseline|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425481|NCT00552578|B1|Baseline|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425482|NCT00552578|P2|Participant Flow|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425483|NCT00552578|P1|Participant Flow|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425484|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425485|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425486|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425487|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425488|NCT00552578|O2|Outcome|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425489|NCT00552578|O1|Outcome|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425490|NCT00552578|E2|Reported Event|Steady Dose of Buprenorphine|Participants assigned to this arm will receive a steady dose of buprenorphine for maintenance.
425491|NCT00552578|E1|Reported Event|Tapering Doses of Buprenorphine|Participants assigned to this arm will receive tapering doses of buprenorphine for detoxification.
425492|NCT00552513|B3|Baseline|Total|Total of all reporting groups
425493|NCT00552513|B2|Baseline|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
425494|NCT00552513|B1|Baseline|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
425495|NCT00552513|P2|Participant Flow|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
425496|NCT00552513|P1|Participant Flow|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
425497|NCT00552513|O2|Outcome|Delayed Intervention|
425498|NCT00552513|O1|Outcome|Early Intervention|
425499|NCT00552513|O2|Outcome|Delayed Intervention|
425500|NCT00552513|O1|Outcome|Early Intervention|
425501|NCT00552513|O2|Outcome|Delayed Intervention|Coronary angiography to be performed after a minimum delay of 36 hours after randomization
425502|NCT00552513|O1|Outcome|Early Intervention|Coronary angiography to be performed as rapidly as possible and within 24 hours after randomization
425503|NCT00552513|E2|Reported Event|Delayed|Delayed intervention: Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) any time after 36 hours after randomisation.
425504|NCT00552513|E1|Reported Event|Early|Coronary angiography and intervention (either percutaneous coronary intervention [PCI] or coronary artery bypass graft [CABG] surgery) as soon as possible (within 24 hours of randomisation).
425506|NCT00552448|B2|Baseline|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425507|NCT00552448|B1|Baseline|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425508|NCT00552448|P2|Participant Flow|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425509|NCT00552448|P1|Participant Flow|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425510|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425511|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425512|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425513|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425514|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425515|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425516|NCT00552448|O2|Outcome|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425517|NCT00552448|O1|Outcome|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425518|NCT00552448|E2|Reported Event|Pediatric Status Asthmaticus Patients Not Using HFCC|This group will not use the VEST or HFCC. They will just have standard therapy for status asthmaticus. The standard therapy will not be affected if they are in this group.
425519|NCT00552448|E1|Reported Event|Pediatric Status Asthmatics Patients on HFCC Device|"Use of the HFCC device in addition to standard therapy for status asthmaticus. The use of HFCC will not affect the therapy received~High Frequency Chest Compression VEST: every 6 hours for 20 minutes"
425520|NCT00552422|B1|Baseline|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
425521|NCT00552422|P1|Participant Flow|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
425522|NCT00552422|O1|Outcome|Domperidone Arm|"Study subjects will self-administer oral domperidone 10mg four times a day. If symptoms persist for more than 7 days, the investigator may increase the dose to 20mg four times a day. 20mg four times a day will be the maximal dose. Subjects with signiﬁcant renal impairment will received a starting dose of 10mg twice a day. The maximal dose in subjects with signiﬁcant renal impairment will be 20mg twice a day.~domperidone: 10mg orally four times per day"
425523|NCT00552422|E1|Reported Event|Domperidone|Participants ranged from 18-65 years of age. Gender composition was 60$% female and 40% male.
425524|NCT00552409|B3|Baseline|Total|Total of all reporting groups
425525|NCT00552409|B2|Baseline|Placebo|One softgel daily for one year
425526|NCT00552409|B1|Baseline|Cholecalciferol|2000 IU by mouth daily for one year
425527|NCT00552409|P2|Participant Flow|Placebo|One softgel daily for one year
425528|NCT00552409|P1|Participant Flow|Cholecalciferol|2000 IU by mouth daily for one year
425529|NCT00552409|O2|Outcome|Placebo|One softgel daily for one year
425530|NCT00552409|O1|Outcome|Cholecalciferol|2000 IU by mouth daily for one year
425531|NCT00552409|E2|Reported Event|Placebo|One softgel daily for one year
425532|NCT00552409|E1|Reported Event|Cholecalciferol|2000 IU by mouth daily for one year
425533|NCT00552396|B8|Baseline|Total|Total of all reporting groups
425534|NCT00552396|B7|Baseline|3 mg/kg|
425535|NCT00552396|B6|Baseline|1 mg/kg|
425536|NCT00552396|B5|Baseline|0.3 mg/kg|
425537|NCT00552396|B4|Baseline|0.075 mg/kg|
425538|NCT00552396|B3|Baseline|0.015 mg/kg|
425539|NCT00552396|B2|Baseline|0.003 mg/kg|
425540|NCT00552396|B1|Baseline|0.0003 mg/kg|
425541|NCT00552396|P7|Participant Flow|3 mg/kg|
425542|NCT00552396|P6|Participant Flow|1 mg/kg|
425543|NCT00552396|P5|Participant Flow|0.3 mg/kg|
425544|NCT00552396|P4|Participant Flow|0.075 mg/kg|
425545|NCT00552396|P3|Participant Flow|0.015 mg/kg|
425546|NCT00552396|P2|Participant Flow|0.003 mg/kg|
425547|NCT00552396|P1|Participant Flow|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
425548|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425549|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425550|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425551|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425552|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425553|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425554|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Disease Response Assessment by Principal Investigator and Sponsor(Efficacy Population).Stable Disease was defined as not meeting criteria for complete response, very good partial response, partial response, or progressive disease
425555|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
425556|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
425557|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|IV 1 hour infusion
425558|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
425559|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV bolus injection
425560|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV bolus injection
425561|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV bolus injection
425562|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|IV 1 hour infusion
425563|NCT00552396|O6|Outcome|IPH2101 1 mg/kg|IV 1 hour infusion
425564|NCT00552396|O5|Outcome|IPH2101 0.3 mg/kg|IV 1 hour infusion
425565|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|IV 1 hour infusion
425566|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|IV Bolus
425567|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|IV Bolus
425568|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|IV Bolus
425569|NCT00552396|O7|Outcome|IPH2101 3 mg/kg|Participants were administered an IV dose of 3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level.If MTD this is not reached at 3mg/kg, 7 subjects will be enrolled at this dose to obtain more data from a larger subject pool to better evaluate safety, PK, PD and signs of efficacy.
425570|NCT00552396|O6|Outcome|IPH2101 1mg/kg|Participants were administered an IV dose of 1 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425571|NCT00552396|O5|Outcome|IPH2101 0.3mg/kg|Participants were administered an IV dose of 0.3mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425572|NCT00552396|O4|Outcome|IPH2101 0.075 mg/kg|Participants were administered an IV dose of 0.075 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425573|NCT00552396|O3|Outcome|IPH2101 0.015 mg/kg|Participants were administered an IV dose of 0.015 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425574|NCT00552396|O2|Outcome|IPH2101 0.003 mg/kg|Participants were administered an IV dose of 0.003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425575|NCT00552396|O1|Outcome|IPH2101 0.0003 mg/kg|Participants were administered an IV dose of 0.0003 mg/kg IPH2101 every 4 weeks for 4 cycles. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level.
425576|NCT00552396|E7|Reported Event|3 mg/kg|
425577|NCT00552396|E6|Reported Event|1 mg/kg|
425578|NCT00552396|E5|Reported Event|0.3 mg/kg|
425579|NCT00552396|E4|Reported Event|0.075 mg/kg|
425580|NCT00552396|E3|Reported Event|0.015 mg/kg|
425581|NCT00552396|E2|Reported Event|0.003 mg/kg|
425582|NCT00552396|E1|Reported Event|0.0003 mg/kg|3+3 design was employed for the first dosing cycle at each dose level. The 7 dose levels were 0.0003 mg/kg, 0.003 mg/kg, 0.015 mg/kg, 0.075 mg/kg, 0.3 mg/kg, 1.0 mg/kg, and 3.0 mg/kg. The subjects received up to a total of 4 administrations of Anti-KIR (1-7F9) with a dosing interval between each administration of 4 weeks.
425583|NCT00552344|B1|Baseline|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425584|NCT00552344|P1|Participant Flow|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425585|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425586|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425587|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
425588|NCT00552344|O1|Outcome|Certolizumab Pegol (Intention-to-Treat)|"Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.~The ITT Population includes all enrolled subjects irrespective of any protocol deviations who received at least 1 open-label injection of study treatment and who had at least 1 efficacy measurement after the first open-label injection."
425589|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425590|NCT00552344|O1|Outcome|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425591|NCT00552344|E1|Reported Event|Certolizumab Pegol|Certolizumab Pegol 200 mg/vial; 400 mg subcutaneously at Week 0, 2 and 4, thereafter 400 mg subcutaneously at every 4 weeks.
425592|NCT00552305|B1|Baseline|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425593|NCT00552305|P1|Participant Flow|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425594|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425595|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425596|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425597|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425598|NCT00552305|O1|Outcome|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425599|NCT00552305|E1|Reported Event|Lacosamide|50mg and 100mg tablets of lacosamide up to 800 mg/day as twice daily (BID) dosing throughout the trial (flexible dosing)
425600|NCT00552279|B3|Baseline|Total|Total of all reporting groups
425601|NCT00552279|B2|Baseline|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425602|NCT00552279|B1|Baseline|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425603|NCT00552279|P2|Participant Flow|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425604|NCT00552279|P1|Participant Flow|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425605|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425606|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425607|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425608|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425609|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425610|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425611|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425612|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425613|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425614|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425615|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425616|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425617|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425618|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425619|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425620|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425621|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425622|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425623|NCT00552279|O2|Outcome|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425624|NCT00552279|O1|Outcome|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425625|NCT00552279|E2|Reported Event|Cervarix-6 Group|Women received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
425626|NCT00552279|E1|Reported Event|Cervarix-12 Group|Women received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 12-month schedule.
425627|NCT00552240|B3|Baseline|Total|Total of all reporting groups
425628|NCT00552240|B2|Baseline|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425629|NCT00552240|B1|Baseline|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425630|NCT00552240|P2|Participant Flow|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425631|NCT00552240|P1|Participant Flow|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425632|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425633|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425634|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425635|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425636|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425637|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425638|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425639|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425640|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425641|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425642|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425643|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425644|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425645|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425646|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425647|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425648|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425649|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425650|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425651|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425652|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425653|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425654|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425655|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425656|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425657|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425658|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425659|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425660|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425661|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425662|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425663|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425664|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425665|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425666|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425667|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425668|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425669|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425670|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425671|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425672|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425673|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425674|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425675|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425676|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425677|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425678|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425679|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425680|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425681|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425682|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425683|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425684|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425685|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425686|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425687|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425688|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425689|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425690|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425691|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425692|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425693|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425694|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425695|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425696|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425697|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425698|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425699|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425700|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425701|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425702|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425703|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425704|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425705|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425706|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425707|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425708|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425709|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425710|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425711|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425712|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425713|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425714|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425715|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425716|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425717|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425718|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425719|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425720|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425721|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425722|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425723|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425724|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425725|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425726|NCT00552240|O2|Outcome|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
426220|NCT00550862|P2|Participant Flow|INT-747 25 mg|
425727|NCT00552240|O1|Outcome|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425728|NCT00552240|E2|Reported Event|Atazanavir Plus Ritonavir (ATV/r) Plus Truvada|Atazanavir 300 mg plus ritonavir 100 mg quaque die (QD)
425729|NCT00552240|E1|Reported Event|Nevirapine (NVP) Plus Truvada|Nevirapine 200 mg bis in die (BID)
425730|NCT00552188|B3|Baseline|Total|Total of all reporting groups
425731|NCT00552188|B2|Baseline|Placebo|Matching placebo
425732|NCT00552188|B1|Baseline|VIA-2291|VIA-2291 100mg
425733|NCT00552188|P2|Participant Flow|Placebo|Matching placebo
425734|NCT00552188|P1|Participant Flow|VIA-2291|VIA-2291 100mg
425735|NCT00552188|O2|Outcome|Placebo|Matching placebo
425736|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
425737|NCT00552188|O2|Outcome|Placebo|Matching placebo
425738|NCT00552188|O1|Outcome|VIA-2291|VIA-2291 100mg
425739|NCT00552188|E2|Reported Event|Placebo|Matching placebo
425740|NCT00552188|E1|Reported Event|VIA-2291|VIA-2291 100mg
425741|NCT00552175|B4|Baseline|Total|Total of all reporting groups
425742|NCT00552175|B3|Baseline|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425743|NCT00552175|B2|Baseline|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425744|NCT00552175|B1|Baseline|Placebo|placebo comparator taken orally every day
425745|NCT00552175|P3|Participant Flow|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425746|NCT00552175|P2|Participant Flow|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425747|NCT00552175|P1|Participant Flow|Placebo|placebo comparator taken orally every day
425748|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425749|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425750|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425751|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425752|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425753|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425754|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425755|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425756|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425757|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425758|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425759|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425760|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425761|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425762|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425763|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425764|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425765|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425766|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425767|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425768|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425769|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425770|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425771|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425772|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425773|NCT00552175|O3|Outcome|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425774|NCT00552175|O2|Outcome|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425775|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425776|NCT00552175|O2|Outcome|Duloxetine 40 mg and 60 mg Combined|Duloxetine 40 milligrams (mg) taken orally every day, and Duloxetine 60 mg taken orally every day.
425777|NCT00552175|O1|Outcome|Placebo|placebo comparator taken orally every day
425778|NCT00552175|E3|Reported Event|Duloxetine 60 mg|Duloxetine 60 milligrams (mg) taken orally every day
425779|NCT00552175|E2|Reported Event|Duloxetine 40 mg|Duloxetine 40 milligrams (mg) taken orally every day
425780|NCT00552175|E1|Reported Event|Placebo|placebo comparator taken orally every day
425781|NCT00552110|B6|Baseline|Total|Total of all reporting groups
425782|NCT00552110|B5|Baseline|Placebo|Placebo nasal spray
425783|NCT00552110|B4|Baseline|Oxymetazoline|OXY twice daily
425784|NCT00552110|B3|Baseline|Mometasone|MFNS once daily
425785|NCT00552110|B2|Baseline|Combination3|MFNS with OXY 3 sprays once daily
425786|NCT00552110|B1|Baseline|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
425787|NCT00552110|P5|Participant Flow|Placebo|Placebo nasal spray
425788|NCT00552110|P4|Participant Flow|Oxymetazoline|OXY twice daily
425789|NCT00552110|P3|Participant Flow|Mometasone|MFNS once daily
425790|NCT00552110|P2|Participant Flow|Combination3|MFNS with OXY 3 sprays once daily
425791|NCT00552110|P1|Participant Flow|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
425792|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
425793|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
425794|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
425795|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
425796|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
425797|NCT00552110|O5|Outcome|Placebo|Placebo nasal spray
425798|NCT00552110|O4|Outcome|Oxymetazoline|OXY twice daily
425799|NCT00552110|O3|Outcome|Mometasone|MFNS once daily
425800|NCT00552110|O2|Outcome|Combination3|MFNS with OXY 3 sprays once daily
425801|NCT00552110|O1|Outcome|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
425802|NCT00552110|E5|Reported Event|Placebo|Placebo nasal spray
425803|NCT00552110|E4|Reported Event|Oxymetazoline|OXY twice daily
425804|NCT00552110|E3|Reported Event|Mometasone|MFNS once daily
425805|NCT00552110|E2|Reported Event|Combination3|MFNS with OXY 3 sprays once daily
425806|NCT00552110|E1|Reported Event|Combination1|Mometasone Furoate nasal spray (MFNS) with oxymetazoline nasal spray (OXY) 1 spray once daily
425807|NCT00552084|B3|Baseline|Total|Total of all reporting groups
425808|NCT00552084|B2|Baseline|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
425809|NCT00552084|B1|Baseline|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
425810|NCT00552084|P2|Participant Flow|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
425811|NCT00552084|P1|Participant Flow|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
425812|NCT00552084|O2|Outcome|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
425813|NCT00552084|O1|Outcome|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
425814|NCT00552084|E2|Reported Event|Placebo|"corn oil taken daily for 24 weeks~Placebo: Placebo supplements will be taken daily for 24 weeks."
425815|NCT00552084|E1|Reported Event|Fish Oil|"4 grams fish oil daily for 24 weeks~Fish oil: Fish oil supplements 4 gms will be taken daily for 24 weeks."
425816|NCT00552058|B3|Baseline|Total|Total of all reporting groups
425817|NCT00552058|B2|Baseline|Placebo|Placebo, saline solution for sc injection
425818|NCT00552058|B1|Baseline|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425819|NCT00552058|P2|Participant Flow|Placebo|Placebo, saline solution for sc injection
425820|NCT00552058|P1|Participant Flow|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425821|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425822|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425823|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425824|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425825|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425826|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425827|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425828|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425829|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425830|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425831|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425832|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425833|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425834|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425835|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425836|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425837|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425838|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425839|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425840|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425841|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425842|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425843|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425844|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425845|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425846|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425847|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425848|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425849|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425850|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425851|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425852|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425853|NCT00552058|O2|Outcome|Placebo|Placebo, saline solution for sc injection
425854|NCT00552058|O1|Outcome|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425855|NCT00552058|E2|Reported Event|Placebo|Placebo, saline solution for sc injection
425856|NCT00552058|E1|Reported Event|Certolizumab Pegol|Certolizumab pegol 400 mg for subcutaneous (sc) injection
425857|NCT00552032|B3|Baseline|Total|Total of all reporting groups
425858|NCT00552032|B2|Baseline|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425859|NCT00552032|B1|Baseline|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425860|NCT00552032|P2|Participant Flow|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425861|NCT00552032|P1|Participant Flow|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425862|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425863|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425864|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425865|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425866|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425867|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425868|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425869|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425870|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425871|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425872|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425873|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425874|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425875|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425876|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425877|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425878|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425879|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425880|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425881|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425882|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425883|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425884|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425885|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425886|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425887|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
426221|NCT00550862|P1|Participant Flow|INT-747 10 mg|
425888|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425889|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425890|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425891|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425892|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425893|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425894|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425895|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425896|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425897|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425898|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425899|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425900|NCT00552032|O2|Outcome|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425901|NCT00552032|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425902|NCT00552032|E2|Reported Event|Placebo Nasal Spray|1 spray in each nostril twice daily administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425903|NCT00552032|E1|Reported Event|Mometasone Furoate Nasal Spray|1 spray (50 mcg) in each nostril twice daily (equivalent to 200 mcg per day) administered for 8 weeks. There was a blinded follow-up period of 16 weeks, resulting in study duration of 24 weeks (6 months).
425904|NCT00551759|B1|Baseline|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
425905|NCT00551759|P1|Participant Flow|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
425906|NCT00551759|O1|Outcome|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|"Neoadjuvant chemoradiotherapy and cetuximab: Patients (pts) receive oxaliplatin IV over 2 hours on days 1, 15, and 29, cetuximab IV over 1-2 hours on days 1, 8, 15, 22, and 29, and 5-FU IV over 24 hours on days 1-35. Pts also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, and 29-33. Pts then proceed to surgery.~Surgery: Pts undergo surgical resection within 4-8 weeks after completion of neoadjuvant chemoradiotherapy and cetuximab. Pts with an R0 or R1 resection proceed to adjuvant therapy. Pts whose tumors have not been completely resected or who have metastatic disease discontinue protocol therapy and receive further therapy at the discretion of the treating physician.~Adjuvant therapy: Within 4-8 weeks after surgery, pts receive docetaxel IV over 1 hour on days 1, 8, 15, 22, and 29 and cetuximab IV over 1-2 hours on days 1, 8, 15, 22, 29, and 36. Treatment repeats every 6 weeks for 2 courses in the absence of disease progression or unacceptable toxicity."
425907|NCT00551759|E1|Reported Event|Neoadjuvant Therapy, Surgery, Adjuvant Therapy|35 days of neoadjuvant chemoradiotherapy with oxaliplatin and infusional 5-fluorouracil plus cetuximab followed by post-operative docetaxel and cetuximab.
425908|NCT00551746|B3|Baseline|Total|Total of all reporting groups
426222|NCT00550862|O4|Outcome|Placebo|
425909|NCT00551746|B2|Baseline|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
425910|NCT00551746|B1|Baseline|Grape Juice|100% Grape Juice
425911|NCT00551746|P2|Participant Flow|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
425912|NCT00551746|P1|Participant Flow|Grape Juice|100% Grape Juice
425913|NCT00551746|O2|Outcome|Placebo|Taste, color, and colorically matched grape juice placebo
425914|NCT00551746|O1|Outcome|Purple Grape Juice|100% grape juice
425915|NCT00551746|E2|Reported Event|Grape Juice Placebo|Taste, color, and calorically matched grape juice placebo
425916|NCT00551746|E1|Reported Event|Grape Juice|100% Grape Juice
425917|NCT00551707|B6|Baseline|Total|Total of all reporting groups
425918|NCT00551707|B5|Baseline|Placebo|"placebo~placebo: placebo"
425919|NCT00551707|B4|Baseline|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
425920|NCT00551707|B3|Baseline|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
425921|NCT00551707|B2|Baseline|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
425922|NCT00551707|B1|Baseline|CRx-102 (2.7/180)|Crx-102 (Dose 1) 2.7 mg prednisolone plus 180 mg dipyridamole
425923|NCT00551707|P5|Participant Flow|Placebo|"placebo~placebo: placebo"
425924|NCT00551707|P4|Participant Flow|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
425925|NCT00551707|P3|Participant Flow|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
425926|NCT00551707|P2|Participant Flow|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
425927|NCT00551707|P1|Participant Flow|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
425928|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
425929|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole 360 mg"
425930|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
425931|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
425932|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|"Crx-102 (Dose 1)~2.7 mg prednisolone plus 180 mg dipyridamole"
425933|NCT00551707|O5|Outcome|Placebo|"placebo~placebo: placebo"
425934|NCT00551707|O4|Outcome|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (360 mg)"
425935|NCT00551707|O3|Outcome|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
425936|NCT00551707|O2|Outcome|CRx-102 (2.7/360)|"Crx-102 (Dose 2)~2.7 mg prednisolone plus 360 mg dipyridamole"
425937|NCT00551707|O1|Outcome|CRx-102 (2.7/180)|CRx-102 dose 1 2.7 mg prednisolone plus 180 mg dipyridamole
425938|NCT00551707|E5|Reported Event|Placebo|"placebo~placebo: placebo"
425939|NCT00551707|E4|Reported Event|Dipyridamole|"dipyridamole~dipyridamole: dipyridamole (180 mg or 360 mg)"
425940|NCT00551707|E3|Reported Event|Prednisolone|"prednisolone~prednisolone: prednisolone (2.7 mg)"
425941|NCT00551707|E2|Reported Event|CRx-102 (Dose 2)|"Crx-102 (Dose 2)~CRx-102: prednisolone + dipyridamole"
425942|NCT00551707|E1|Reported Event|CRx-102 (Dose 1)|"Crx-102 (Dose 1)~CRx-102: prednisolone + dipyridamole"
425943|NCT00551642|B3|Baseline|Total|Total of all reporting groups
425944|NCT00551642|B2|Baseline|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
425945|NCT00551642|B1|Baseline|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
425946|NCT00551642|P2|Participant Flow|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
425947|NCT00551642|P1|Participant Flow|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
425948|NCT00551642|O2|Outcome|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
425949|NCT00551642|O1|Outcome|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
425950|NCT00551642|E2|Reported Event|Placebo (Nitrogen)|Placebo Nitrogen gas administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million for a maximum of 21 days
425951|NCT00551642|E1|Reported Event|Inhaled Nitric Oxide (NO)|Inhaled NO administered by nasal continuous positve airway pressure, nasal cannula or face mask at 5 parts per million (ppm) for a maximum of 21 days
425952|NCT00551421|B1|Baseline|Pertuzumab and Cetuximab|Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
425953|NCT00551421|P1|Participant Flow|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
425987|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425954|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
425955|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
425956|NCT00551421|O1|Outcome|Arm I|"Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1. Patients also receive cetuximab IV over 60-120 minutes on days 2, 8, and 15 of course 1 and on days 1, 8, and 15 in all subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~pertuzumab: Given IV~cetuximab: Given IV~irinotecan hydrochloride: Given IV~immunohistochemistry staining method: Correlative study~fluorescence in situ hybridization: Correlative study~gene expression analysis: Correlative study~mutation analysis: Correlative study~polymerase chain reaction: Correlative study~laboratory biomarker analysis: Correlative study"
425957|NCT00551421|O1|Outcome|Pertuzumab and Cetuximab|"Original Protocol, Phase I: Patients receive pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose cycle 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose only), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as Original Protocol (see above) without a loading dose of Cetuximab (maintenance dose given on cycle 1, day 2 instead).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: irinotecan hydrochloride, pertuzumab, cetuximab~Correlative Studies: laboratory biomarker analysis, gene expression analysis, fluorescence in situ hybridization, mutation analysis, polymerase chain reaction, immunohistochemistry staining method"
425958|NCT00551421|E1|Reported Event|Pertuzumab and Cetuximab|"Original Protocol: Patients received pertuzumab IV over 30-60 minutes on day 1 of each cycle (loading dose on cycle 1, day 1 only). Patients also receive cetuximab IV over 60-120 minutes on days 2 (loading dose), 8, and 15 of cycle 1 and on days 1, 8, and 15 in all subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Amended Protocol, Phase I: Same as the Original Protocol (see above) except the Cetuximab loading dose was no longer given on cycle 1, day 2 (maintainance dose given).~Phase II: Patients receive treatment as in phase I. Pertuzumab is administered at the recommended phase II dose (determined in phase I).~Given IV: pertuzumab, cetuximab, irinotecan hydrochloride~Corrlateive studies: immunohistochemistry staining method, fluorescence in situ hybridization, gene expression analysis, mutation analysis, polymerase chain reaction, laboratory biomarker analysis"
425959|NCT00551369|B1|Baseline|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425960|NCT00551369|P1|Participant Flow|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425961|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425962|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425963|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425964|NCT00551369|O1|Outcome|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425965|NCT00551369|E1|Reported Event|SBRT|Stereotactic body radiation therapy (SBRT) delivered in 3 fractions of 20 Gy/fraction over 1.5 to 2 weeks for a total of 60 Gy
425966|NCT00551291|B1|Baseline|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
425967|NCT00551291|P1|Participant Flow|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
425968|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
426009|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426010|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
425969|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
425970|NCT00551291|O1|Outcome|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
425971|NCT00551291|E1|Reported Event|Mycophenolate Mofetil + Prednisone + Erythropoietin Beta|"Mycophenolate mofetil (MMF) 1 gm twice daily orally and prednisone 10 mg/day orally until the end of the study. Recombinant human erythropoietin beta 30,000 IU/week, subcutaneously for 6 weeks was added in case of no significant response at Week 12.~Mycophenolate mofetil: 1 gm twice daily orally until end of study.~Prednisone: 10 mg/day orally until end of study.~Erythropoietin Beta: Recombinant human erythropoietin beta at doses of 30,000 IU/week by the subcutaneous route for 6 weeks."
425972|NCT00551213|B3|Baseline|Total|Total of all reporting groups
425973|NCT00551213|B2|Baseline|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425974|NCT00551213|B1|Baseline|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425975|NCT00551213|P2|Participant Flow|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425976|NCT00551213|P1|Participant Flow|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg intravenously (IV) followed by 1 dose of robatumumab 10 mg/kg IV once every 2 weeks (Q2W) until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425977|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425978|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425979|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425980|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425981|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425982|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425983|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425984|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425985|NCT00551213|O2|Outcome|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425986|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
426218|NCT00550862|P4|Participant Flow|Placebo|
425988|NCT00551213|O1|Outcome|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425989|NCT00551213|E2|Reported Event|Robatumumab→Robatumumab|Participants receive 1 dose of robatumumab 0.3 mg/kg IV followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425990|NCT00551213|E1|Reported Event|Chemotherapy→Robatumumab|Participants receive 1 cycle of standard colorectal cancer chemotherapy currently approved and available on the market for use in colorectal cancer (to be selected by the Investigator based on participant's prior treatment) followed by 1 dose of robatumumab 10 mg/kg IV Q2W until disease progression. A cycle of robatumumab is defined as 2 weeks of treatment (i.e., 1 dose of robatumumab) with no recovery period between cycles.
425991|NCT00551200|B1|Baseline|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
425992|NCT00551200|P1|Participant Flow|Buphenyl to HPN-100|HPN-100 : Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study, and then switched over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 was increased and the dose of Buphenyl® was decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate was HPN-100. Target HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week and then switched back to previous dose of Buphenyl for the last week of the study.
425993|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
425994|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
425995|NCT00551200|O2|Outcome|HPN-100|HPN-100 dose contained the same amount of phenylbutyrates as the subject's prescribed daily dose of Buphenyl®. Subject took HPN-100 alone for one week to reach steady state before blood sample collection.
425996|NCT00551200|O1|Outcome|Buphenyl|Subjects took prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects took prescribed dose of Buphenyl® TID for first week of study before blood sample collection.
425997|NCT00551200|O1|Outcome|Buphenyl to HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
425998|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
425999|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
426000|NCT00551200|O2|Outcome|HPN-100 Steady State|After dose escalation to full dose of HPN-100 was completed, subjects received only HPN-100 for 1 week (and achieved steady state) prior to switching back to their original NaPBA treatment.
426001|NCT00551200|O1|Outcome|NaPBA Steady State|Subjects were on NaPBA TID treatment for at least 2 weeks prior to enrollment, and were thus expected to be at steady-state levels prior to enrollment. After enrollment, subjects received 1 week of NaPBA treatment before switching over to HPN-100 dose escalation phase.
426002|NCT00551200|E2|Reported Event|HPN-100|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
426003|NCT00551200|E1|Reported Event|Buphenyl|HPN-100 : Subjects will be taking prescribed dose of Buphenyl® TID (not to exceed 20g/day) at least two weeks prior to enrollment. Subjects will take prescribed dose of Buphenyl® TID for first week of study, and then switch over to HPN-100 TID during a dose-escalation phase. The dose of HPN-100 will be increased and the dose of Buphenyl® will be decreased each week by 50 mg/kg until entire daily dose of phenylbutyrate is HPN-100. Target HPN-100 dose will contain the same amount of phenylbutyrate as the subject's prescribed daily dose of Buphenyl®. Subject will take HPN-100 alone for one week and then switch back to previous dose of Buphenyl for the last week of the study.
426004|NCT00551174|B3|Baseline|Total|Total of all reporting groups
426005|NCT00551174|B2|Baseline|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426006|NCT00551174|B1|Baseline|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426007|NCT00551174|P2|Participant Flow|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426008|NCT00551174|P1|Participant Flow|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426011|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426012|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426013|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426014|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426015|NCT00551174|O2|Outcome|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426016|NCT00551174|O1|Outcome|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426017|NCT00551174|E2|Reported Event|3 mg Ibandronate q3mo|3 mg ibandronate intravenously (IV) every 3 months (q3mo) for 3 years
426018|NCT00551174|E1|Reported Event|2 mg Ibandronate q2mo|2 mg ibandronate intravenously (IV) every 2 months (q2mo) for 3 years
426019|NCT00551161|B1|Baseline|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
426020|NCT00551161|P1|Participant Flow|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
426021|NCT00551161|O1|Outcome|Memantine|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
426022|NCT00551161|E1|Reported Event|Single-arm|24-week observational lead-in period, wherein patients already on a stable dose of donepezil, rivastigmine, or galantamine continue on that dose, followed by a 24-week open-label memantine period, wherein patients receive open-label memantine treatment titrated to a dose of 20 mg per day, in addition to their ongoing stable cholinesterase inhibitor treatment
426023|NCT00551135|B5|Baseline|Total|Total of all reporting groups
426024|NCT00551135|B4|Baseline|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426025|NCT00551135|B3|Baseline|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426026|NCT00551135|B2|Baseline|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426027|NCT00551135|B1|Baseline|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426028|NCT00551135|P4|Participant Flow|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426029|NCT00551135|P3|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426030|NCT00551135|P2|Participant Flow|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426031|NCT00551135|P1|Participant Flow|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426032|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426033|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426034|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426035|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426036|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426037|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426038|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426039|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426040|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426041|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426042|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426043|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426044|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426045|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426046|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426047|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426048|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426049|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426050|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426051|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426052|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426053|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426054|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426055|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426056|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426057|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426058|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426059|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426060|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426061|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426062|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426063|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426064|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426065|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426066|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426067|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426068|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426069|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426070|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426071|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426072|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426073|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426074|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426075|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426076|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426077|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426078|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426079|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426080|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426081|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426082|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426083|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426084|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426085|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426086|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426087|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426088|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426089|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426090|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426091|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426092|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426093|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426094|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426095|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426096|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426097|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426098|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426099|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426100|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426101|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426102|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426103|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426104|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426105|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426106|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426107|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426108|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426109|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426110|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426111|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426112|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426113|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426114|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426115|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426116|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426117|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426118|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426119|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426120|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426121|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426122|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426123|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426124|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426125|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426126|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426127|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426128|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426129|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426130|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426131|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426132|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426133|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426134|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426135|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426136|NCT00551135|O4|Outcome|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426137|NCT00551135|O3|Outcome|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426138|NCT00551135|O2|Outcome|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426139|NCT00551135|O1|Outcome|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426140|NCT00551135|E4|Reported Event|Placebo|Placebo capsules administered PO the evening before surgery and 2+/-1 hours before surgery, then Placebo capsules BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo capsules BID for 1 week.
426141|NCT00551135|E3|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 150 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 150 mg PO BID for 1 week.
426142|NCT00551135|E2|Reported Event|Pregabalin 150 mg|Pregabalin 75 mg administered PO the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 75 mg BID PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 75 mg PO BID for 1 week.
426143|NCT00551135|E1|Reported Event|Pregabalin 50 mg|Pregabalin 25 milligrams (mg) administered orally (PO) the evening before surgery and 2+/-1 hours before surgery, then Pregabalin 25 mg twice daily (BID) PO for 1 week until Day 7 post surgery (End of Treatment or Beginning of Taper visit), followed by Placebo 25 mg PO BID for 1 week.
426144|NCT00551070|B1|Baseline|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426145|NCT00551070|P1|Participant Flow|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426146|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426147|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426148|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426149|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426150|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426151|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426152|NCT00551070|O1|Outcome|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426153|NCT00551070|E1|Reported Event|AZD6244|AZD6244 (NSC #748727) 100 mg orally BID until disease progression or adverse effects prohibit further therapy (1 cycle =28 days)
426154|NCT00551031|B6|Baseline|Total|Total of all reporting groups
426155|NCT00551031|B5|Baseline|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426156|NCT00551031|B4|Baseline|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426157|NCT00551031|B3|Baseline|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426158|NCT00551031|B2|Baseline|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426159|NCT00551031|B1|Baseline|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426160|NCT00551031|P5|Participant Flow|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426161|NCT00551031|P4|Participant Flow|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426162|NCT00551031|P3|Participant Flow|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426163|NCT00551031|P2|Participant Flow|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426164|NCT00551031|P1|Participant Flow|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426165|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426166|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426167|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426168|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426219|NCT00550862|P3|Participant Flow|INT-747 50 mg|
426169|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426170|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426171|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426172|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426173|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426174|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426175|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426176|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426177|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426178|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426179|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426180|NCT00551031|O5|Outcome|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426181|NCT00551031|O4|Outcome|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426182|NCT00551031|O3|Outcome|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426183|NCT00551031|O2|Outcome|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426184|NCT00551031|O1|Outcome|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426185|NCT00551031|E5|Reported Event|Fluzone® Adults Group|Participants aged 18 to 49 years who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426186|NCT00551031|E4|Reported Event|Fluzone® High Dose Group|Participants aged 65 years or older who received 1 dose of Fluzone 60 µg intramuscularly (IM)
426187|NCT00551031|E3|Reported Event|Fluzone® Elderly Group|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intramuscularly (IM)
426188|NCT00551031|E2|Reported Event|Influenza Virus Vaccine Formulation 2|Participants aged 65 years or older who received 1 dose of Fluzone 21 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426189|NCT00551031|E1|Reported Event|Influenza Virus Vaccine Formulation 1|Participants aged 65 years or older who received 1 dose of Fluzone 15 µg intradermally (ID) using the Becton Dickenson Micro Injection System
426190|NCT00550953|B3|Baseline|Total|Total of all reporting groups
426191|NCT00550953|B2|Baseline|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426192|NCT00550953|B1|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426193|NCT00550953|P2|Participant Flow|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426194|NCT00550953|P1|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426195|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426196|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426197|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426198|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426199|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426200|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426201|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426202|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426203|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426204|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426205|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426206|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426207|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426208|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426209|NCT00550953|O2|Outcome|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426210|NCT00550953|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426211|NCT00550953|E2|Reported Event|Telmisartan 40 mg Monotherapy|A5 capsule, oral, once daily in the morning
426212|NCT00550953|E1|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg Fixed-dose Combination|T40/A5 tablet, oral, once daily in the morning
426213|NCT00550862|B5|Baseline|Total|Total of all reporting groups
426214|NCT00550862|B4|Baseline|Placebo|
426215|NCT00550862|B3|Baseline|INT-747 50 mg|
426216|NCT00550862|B2|Baseline|INT-747 25 mg|
426217|NCT00550862|B1|Baseline|INT-747 10 mg|
426223|NCT00550862|O3|Outcome|INT-747 50 mg|
426224|NCT00550862|O2|Outcome|INT-747 25 mg|
426225|NCT00550862|O1|Outcome|INT-747 10 mg|
426226|NCT00550862|O4|Outcome|Placebo|
426227|NCT00550862|O3|Outcome|INT-747 50 mg|
426228|NCT00550862|O2|Outcome|INT-747 25 mg|
426229|NCT00550862|O1|Outcome|INT-747 10 mg|
426230|NCT00550862|O4|Outcome|Placebo|
426231|NCT00550862|O3|Outcome|INT-747 50 mg|
426232|NCT00550862|O2|Outcome|INT-747 25 mg|
426233|NCT00550862|O1|Outcome|INT-747 10 mg|
426234|NCT00550862|E4|Reported Event|Placebo|
426235|NCT00550862|E3|Reported Event|INT-747 50 mg|
426236|NCT00550862|E2|Reported Event|INT-747 25 mg|
426237|NCT00550862|E1|Reported Event|INT-747 10 mg|
426238|NCT00550771|B3|Baseline|Total|Total of all reporting groups
426239|NCT00550771|B2|Baseline|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426240|NCT00550771|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426241|NCT00550771|P2|Participant Flow|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426242|NCT00550771|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426243|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426244|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426245|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426246|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426247|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426248|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426249|NCT00550771|O2|Outcome|Doxorubicin Based Regimen|doxorubicin 60 mg/m^2 intravenous (IV) push + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes (first administration 4 mg/kg IV over 90 minutes) given weekly for 12 weeks (4 courses)
426250|NCT00550771|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD) Based Regimen|PLD 35 mg/m^2 IV over 60 minutes + cyclophosphamide 600 mg/m^2 IV over 30-90 minutes given every 21 days + trastuzumab 2 mg/kg IV over 30 minutes (first dose 4 mg/kg IV over 90 minutes) given once weekly for 4 courses (12 weeks) followed by Paclitaxel 80 mg/m^2 IV over 60 minutes with trastuzumab 2 mg/kg IV over 30 minutes given weekly for 12 weeks (4 courses)
426251|NCT00550771|E2|Reported Event|Doxorubicin Based Regimen|
426252|NCT00550771|E1|Reported Event|PLD Based Regimen|
426253|NCT00550745|B3|Baseline|Total|Total of all reporting groups
426254|NCT00550745|B2|Baseline|Placebo|"Represents the number of subjects according to the treatment (placebo) received.~Excludes subjects who were not vaccinated."
426255|NCT00550745|B1|Baseline|ZOSTAVAX™|"Represents the number of subjects according to the treatment (ZOSTAVAX™) received.~Excludes subjects who were not vaccinated."
426256|NCT00550745|P2|Participant Flow|Placebo|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
426257|NCT00550745|P1|Participant Flow|ZOSTAVAX™|Represents the number of randomized subjects according to the vaccination group as they were assigned at study entry and not the treatment, ZOSTAVAX™ or placebo, received.
426258|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
426259|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
426260|NCT00550745|O2|Outcome|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
426261|NCT00550745|O1|Outcome|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (ZOSTAVAX™) and had safety follow-up.
426262|NCT00550745|E2|Reported Event|Placebo|All subjects who were vaccinated according to actual treatment received (Placebo) and had safety follow-up.
426263|NCT00550745|E1|Reported Event|ZOSTAVAX™|All subjects who were vaccinated according to actual treatment received (Zostavax™) and had safety follow-up.
426264|NCT00550732|B1|Baseline|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426265|NCT00550732|P1|Participant Flow|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426266|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426267|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426268|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426269|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426270|NCT00550732|O1|Outcome|Prosaconazole|Posaconazole oral suspension was administered as 400 mg BID with food or 200 mg QID without food for a minimum of one month.
426271|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426272|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426273|NCT00550732|O1|Outcome|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426274|NCT00550732|E1|Reported Event|Posaconazole|Posaconazole oral suspension was administered as 400 mg twice daily (bis in die, BID) with food or 200 mg four times daily (quater in die, QID) without food for a minimum of 1 month.
426275|NCT00550680|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426276|NCT00550680|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain hemoglobin (Hb) concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
426277|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426278|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426279|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426280|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426281|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426282|NCT00550680|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426328|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426329|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426330|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426283|NCT00550680|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted to maintain Hb concentrations within target of 10.5 and 12.5 g/dL.
426284|NCT00550654|B1|Baseline|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426285|NCT00550654|P1|Participant Flow|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426286|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426287|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426288|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426289|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426290|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426291|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426292|NCT00550654|O1|Outcome|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426293|NCT00550654|E1|Reported Event|Radiation Therapy in Metastatic Cancer|Patients undergo hypofractionated highly conformal radiotherapy with helical tomotherapy once every other day over 5 days for a total of 3 fractions.
426294|NCT00550589|B1|Baseline|Cidofovir|1.0% topical cidofovir cream
426295|NCT00550589|P1|Participant Flow|Cidofovir|1.0% topical cidofovir cream
426296|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426297|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426298|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426299|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426300|NCT00550589|O1|Outcome|Cidofovir|"1.0% topical cidofovir cream~cidofovir: 1.0% topical cream self-applied once daily for 5 consecutive days, with no treatment for the remaining 9 days (a treatment cycle). Subjects will receive up to 6 cycles of treatment.~DNA methylation analysis: formalin fixed biopsy collected at baseline and 6 weeks after treatment discontinuation~gene expression analysis: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~polymerase chain reaction: performed on punch biopsy specimens collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~biopsy: punch biopsy collected at baseline, after cycle 1, and 6 weeks after treatment discontinuation~histopathologic examination: Evaluated at baseline and 6 weeks after treatment discontinuation"
426301|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426302|NCT00550589|O1|Outcome|Cidofovir|1% cidofovir
426303|NCT00550589|O1|Outcome|Cidofovir|1.0% topical cidofovir cream
426304|NCT00550589|E1|Reported Event|Cidofovir|1.0% topical cidofovir cream
426305|NCT00550550|B3|Baseline|Total|Total of all reporting groups
426306|NCT00550550|B2|Baseline|Placebo|Matching placebo tablet administered sublingually once daily.
426307|NCT00550550|B1|Baseline|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
426308|NCT00550550|P2|Participant Flow|Placebo|Matching placebo tablet administered sublingually once daily.
426309|NCT00550550|P1|Participant Flow|SCH 697243|SCH 697243 (Phleum pratense extract) administered sublingually once daily.
426310|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
426311|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
426312|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
426313|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
426314|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
426315|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
426316|NCT00550550|O2|Outcome|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
426317|NCT00550550|O1|Outcome|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
426318|NCT00550550|E2|Reported Event|Placebo|Rapidly dissolving matching placebo tablet administered sublingually once daily.
426319|NCT00550550|E1|Reported Event|SCH 697243|Rapidly dissolving grass pollen allergen tablet administered sublingually once daily.
426320|NCT00550459|B3|Baseline|Total|Total of all reporting groups
426321|NCT00550459|B2|Baseline|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426322|NCT00550459|B1|Baseline|Placebo|Placebo tablet given once daily for 21 days
426323|NCT00550459|P2|Participant Flow|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426324|NCT00550459|P1|Participant Flow|Placebo|Placebo tablet given once daily for 21 days
426325|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426326|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426327|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426331|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426332|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426333|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426334|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426335|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426336|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426337|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426338|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426339|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426340|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426341|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426342|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426343|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426344|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426345|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426346|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426347|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426348|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426349|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426350|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426351|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426352|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426353|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426354|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426355|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426356|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426357|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426358|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426359|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426360|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426361|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426362|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426363|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426364|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426365|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426366|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426367|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426368|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426369|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426370|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426371|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426372|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426373|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426374|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426375|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426376|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426377|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426378|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426379|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426380|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426381|NCT00550459|O2|Outcome|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426382|NCT00550459|O1|Outcome|Placebo|Placebo tablet given once daily for 21 days
426383|NCT00550459|E2|Reported Event|Tolvaptan (15-60 mg)|Tolvaptan tablet 15-60 mg given once daily for 21 days
426384|NCT00550459|E1|Reported Event|Placebo|Placebo tablet given once daily for 21 days
426385|NCT00550446|B8|Baseline|Total|Total of all reporting groups
426386|NCT00550446|B7|Baseline|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426387|NCT00550446|B6|Baseline|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426388|NCT00550446|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426389|NCT00550446|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426390|NCT00550446|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426391|NCT00550446|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426392|NCT00550446|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426393|NCT00550446|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426394|NCT00550446|P10|Participant Flow|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426395|NCT00550446|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426396|NCT00550446|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426397|NCT00550446|P7|Participant Flow|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426398|NCT00550446|P6|Participant Flow|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426399|NCT00550446|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426400|NCT00550446|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426401|NCT00550446|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426402|NCT00550446|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426403|NCT00550446|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426404|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426405|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426406|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426407|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426408|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426409|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426410|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426411|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426412|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426413|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426414|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426415|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426416|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426417|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426418|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426419|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426420|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426421|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426422|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426423|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426424|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426425|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426426|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426427|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426428|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426429|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426430|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426431|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426432|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426433|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426434|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426435|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426436|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426437|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426438|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426439|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
428094|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
426440|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426441|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426442|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426443|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426444|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426445|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426446|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426447|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426448|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426449|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426450|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426451|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426452|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426453|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426454|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426455|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426456|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426457|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426458|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426459|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426460|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426461|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426462|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426463|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426464|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426465|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426466|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426467|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426468|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426469|NCT00550446|O10|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426470|NCT00550446|O9|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426471|NCT00550446|O8|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426472|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426473|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426474|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426475|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426476|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426477|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426478|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426479|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426480|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426481|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426482|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426483|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426484|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426485|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426486|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426487|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426488|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426489|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
427007|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426490|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426491|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426492|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426493|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426494|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426495|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426496|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426497|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426498|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426499|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426500|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426501|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426502|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426503|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426504|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426505|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426506|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426507|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426508|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426509|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426510|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426511|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426512|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426513|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426514|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
428095|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
426515|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426516|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426517|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426518|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426519|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426520|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426521|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426522|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426523|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426524|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426525|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426526|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426527|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426528|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426529|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426530|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426531|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426532|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426533|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426534|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426535|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426536|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426537|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426538|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426539|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426540|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426541|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426542|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426543|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426544|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426545|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426546|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426547|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426548|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426549|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426550|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426551|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426552|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426553|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426554|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426555|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426556|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426557|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426558|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426559|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426560|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426561|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426562|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426563|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426564|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426565|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426566|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426567|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426568|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426569|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426570|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426571|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426572|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426573|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426574|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426575|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426576|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426577|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426578|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426579|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426580|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426581|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426582|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426583|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426584|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426585|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426586|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426587|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426588|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426589|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426614|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426590|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426591|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426592|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426593|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426594|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426595|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426596|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426597|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426598|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426599|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426600|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426601|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426602|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Participants who administered Adalimumab initially were switched to CP-690,550 5 milligram (mg) tablet from Week 12 to Week 24.
426603|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426604|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426605|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426606|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426607|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426608|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426609|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426610|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426611|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426612|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426613|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427008|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
427009|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426615|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426616|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426617|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426618|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426619|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426620|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426621|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426622|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426623|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426624|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426625|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426626|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426627|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426628|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426629|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426630|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426631|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426632|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426633|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426634|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426635|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426636|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426637|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426638|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426639|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426640|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426641|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426642|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426643|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426644|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426645|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426646|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426647|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426648|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426649|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426650|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426651|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426652|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426653|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426654|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426655|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426656|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426657|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426658|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426659|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426660|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426661|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426662|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426663|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426664|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426714|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
428096|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
426665|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426666|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426667|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426668|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426669|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426670|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426671|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426672|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426673|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426674|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426675|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426676|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426677|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426678|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426679|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426680|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426681|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426682|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426683|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426684|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426685|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426686|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426687|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426688|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426715|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
428097|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
426689|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426690|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426691|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426692|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426693|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426694|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426695|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426696|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426697|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426698|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426699|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426700|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426701|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426702|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426703|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426704|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426705|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426706|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426707|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426708|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426709|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426710|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426711|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426712|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426713|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426716|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426717|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426718|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426719|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426720|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426721|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426722|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426723|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426724|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426725|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426726|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 10 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
426727|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426728|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.Initially CP-690,550 3 mg tablet administered orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10. After Week 12, participants were reassigned CP-690,550 5 mg tablet administered orally twice daily.
426729|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426730|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426731|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426732|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426733|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426734|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426735|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426736|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426737|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426738|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426739|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427010|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427011|NCT00550043|O1|Outcome|Placebo|
426740|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426741|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426742|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426743|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426744|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426745|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426746|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426747|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426748|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426749|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426750|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426751|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426752|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426753|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426754|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426755|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426756|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426757|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426758|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426759|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426760|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 5 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
426761|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426762|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426763|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
427012|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
427013|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426764|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426765|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426766|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426767|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426768|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426769|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426770|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426771|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426772|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426773|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426774|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426775|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426776|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426777|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426778|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426779|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426780|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426781|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426782|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426783|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426784|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426785|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426786|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426787|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.CP-690,550 15 mg tablet orally twice daily plus placebo QOW subcutaneous injections during Week 0 to Week 10.
426788|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426789|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426790|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426791|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426792|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426793|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426794|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426795|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426796|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426797|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426798|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426799|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426800|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426801|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426802|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426803|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426804|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426805|NCT00550446|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426806|NCT00550446|O10|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426807|NCT00550446|O9|Outcome|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426808|NCT00550446|O8|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426809|NCT00550446|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426810|NCT00550446|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426811|NCT00550446|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426812|NCT00550446|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426839|NCT00550407|P1|Participant Flow|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426813|NCT00550446|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426814|NCT00550446|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426815|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426816|NCT00550446|O7|Outcome|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426817|NCT00550446|O6|Outcome|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426818|NCT00550446|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426819|NCT00550446|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426820|NCT00550446|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426821|NCT00550446|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426822|NCT00550446|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426823|NCT00550446|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426824|NCT00550446|E10|Reported Event|Placebo|Placebo matched to CP-690,550 tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections QOW up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to placebo to 5 mg (R) treatment arm for next 12 weeks.
426825|NCT00550446|E9|Reported Event|Adalimumab to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in Adalimumab 40 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426826|NCT00550446|E8|Reported Event|Adalimumab|Adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10 along with placebo matched to CP-690,550 tablet orally twice daily up to Week 12, then CP-690,550 5 mg tablet orally twice daily up to Week 24.
426827|NCT00550446|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426828|NCT00550446|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426829|NCT00550446|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10.
426830|NCT00550446|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426831|NCT00550446|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
426832|NCT00550446|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
426833|NCT00550446|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24, along with placebo matched to adalimumab 40 mg subcutaneous injections every other week (QOW) up to Week 10. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
426834|NCT00550407|B3|Baseline|Total|Total of all reporting groups
426835|NCT00550407|B2|Baseline|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426836|NCT00550407|B1|Baseline|Placebo|Matching placebo
426837|NCT00550407|P3|Participant Flow|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426838|NCT00550407|P2|Participant Flow|Placebo|Matching placebo
426840|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426841|NCT00550407|O1|Outcome|Placebo|Matching placebo
426842|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426843|NCT00550407|O1|Outcome|Placebo|Matching placebo
426844|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426845|NCT00550407|O1|Outcome|Placebo|Matching placebo
426846|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426847|NCT00550407|O1|Outcome|Placebo|Matching placebo
426848|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426849|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426850|NCT00550407|O1|Outcome|Placebo|Matching placebo
426851|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426852|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426853|NCT00550407|O1|Outcome|Placebo|Matching placebo
426854|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426855|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426856|NCT00550407|O1|Outcome|Placebo|Matching placebo
426857|NCT00550407|O1|Outcome|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426858|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426859|NCT00550407|O1|Outcome|Placebo|Matching placebo
426860|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426861|NCT00550407|O1|Outcome|Placebo|Matching placebo
426862|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426863|NCT00550407|O1|Outcome|Placebo|Matching placebo
426864|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426865|NCT00550407|O1|Outcome|Placebo|Matching placebo
426866|NCT00550407|O2|Outcome|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426867|NCT00550407|O1|Outcome|Placebo|Matching placebo
426868|NCT00550407|E3|Reported Event|Lamotrigine 200 mg|Lamotrigine 200 mg once a day. The dose may have been reduced to 100 mg/day for safety reasons at the discretion of the investigator/subinvestigator. The use of other medications for bipolar disorder was prohibited.
426869|NCT00550407|E2|Reported Event|Placebo|Matching placebo
426870|NCT00550407|E1|Reported Event|Lamotrigine 25-200 mg|The dose of lamotrigine was increased gradually in the dose range of 25-200 milligrams (mg)/day, while the doses of other medications for bipolar disorder were decreased gradually
426871|NCT00550368|B3|Baseline|Total|Total of all reporting groups
426872|NCT00550368|B2|Baseline|H. Pylori Positive|Participants who tested H. pylori positive
426873|NCT00550368|B1|Baseline|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426874|NCT00550368|P2|Participant Flow|H. Pylori Positive|Participants who tested H. pylori positive
426875|NCT00550368|P1|Participant Flow|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426876|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
426877|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426878|NCT00550368|O2|Outcome|H. Pylori Positive|Participants who tested H. pylori positive
426879|NCT00550368|O1|Outcome|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426880|NCT00550368|E2|Reported Event|H. Pylori Positive|Participants who tested H. pylori positive
426881|NCT00550368|E1|Reported Event|H. Pylori Negative|Participants who tested negative for H. pylori infection.
426920|NCT00550173|P1|Participant Flow|Pemetrexed + Erlotinib|Pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426882|NCT00550277|B1|Baseline|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426883|NCT00550277|P1|Participant Flow|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426884|NCT00550277|O1|Outcome|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 - 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426885|NCT00550277|E1|Reported Event|Treatment|LBH589 will be administered orally at a dose of 45 mg (1 - 5 mg capsule and 2 – 20 mg capsules) on Monday and Thursday of each week (twice weekly). To enable patients to undergo cardiac monitoring, all patients must begin treatment on a Monday, and continue Monday/Thursday dosing during subsequent treatment cycles. Patients with objective response or stable disease after re-evaluation at week 8 will continue LBH589 at the same dose until disease progression, unacceptable toxicity and/or at the discretion of the investigator.
426886|NCT00547703|B3|Baseline|Total|Total of all reporting groups
426887|NCT00547703|B2|Baseline|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
426888|NCT00547703|B1|Baseline|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
426889|NCT00547703|P2|Participant Flow|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
426890|NCT00547703|P1|Participant Flow|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
426891|NCT00547703|O2|Outcome|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
426892|NCT00547703|O1|Outcome|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
426893|NCT00547703|E2|Reported Event|Placebo|Patients in this group will receive an identical placebo capsule at night for 8 weeks.
426894|NCT00547703|E1|Reported Event|Nortriptyline|Patients in this group will receive Nortriptyline 25mg at night for 8 weeks.
426895|NCT00547638|B3|Baseline|Total|Total of all reporting groups
426896|NCT00547638|B2|Baseline|Dermabond HVD|DERMABOND HVD: Comparator Tissue Adhesive for Topical Application
426897|NCT00547638|B1|Baseline|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo) Tissue adhesive for Topical Application
426898|NCT00547638|P2|Participant Flow|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426899|NCT00547638|P1|Participant Flow|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426900|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426901|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426902|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426903|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426904|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426905|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426906|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426907|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426908|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426909|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426910|NCT00547638|O2|Outcome|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426911|NCT00547638|O1|Outcome|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426912|NCT00547638|E2|Reported Event|Dermabond HVD|DERMABOND HVD: Comparator tissue adhesive for topical application.
426913|NCT00547638|E1|Reported Event|Dermabond Protape (Prineo)|DERMABOND PROTAPE (Prineo: Tissue adhesive for topical application.
426914|NCT00550173|B4|Baseline|Total|Total of all reporting groups
426915|NCT00550173|B3|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426916|NCT00550173|B2|Baseline|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426917|NCT00550173|B1|Baseline|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426918|NCT00550173|P3|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426919|NCT00550173|P2|Participant Flow|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426997|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
428098|NCT00546871|O5|Outcome|Study Extension, SC Administration|
426921|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426922|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426923|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426924|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426925|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426926|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426927|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426928|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426929|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426930|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426931|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426932|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of body surface area, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426933|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426934|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426935|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426936|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426937|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426938|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426939|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426940|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426941|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426942|NCT00550173|O3|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 of each 21-day cycle until progression or unacceptable toxicity developed or up to 38 months.
426943|NCT00550173|O2|Outcome|Erlotinib|Erlotinib 150 mg, administered orally once daily in each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426944|NCT00550173|O1|Outcome|Pemetrexed + Erlotinib|Pemetrexed 500 mg/m^2 of BSA, administered by IV infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21-day cycle until disease progression or unacceptable toxicity developed or up to 38 months.
426945|NCT00550173|E3|Reported Event|Pemetrexed|Participants received pemetrexed 500 mg/m^2 of body surface area, administered by intravenous (IV) infusion on Day 1 of each 21 day cycle until progression or unacceptable toxicity developed up to 39 months.
426946|NCT00550173|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg, administered orally once daily in each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
426947|NCT00550173|E1|Reported Event|Pemetrexed + Erlotinib|Participants received pemetrexed 500 milligrams per meter squared (mg/m^2) of body surface area, administered by intravenous (IV) infusion on Day 1 plus erlotinib 150 mg orally once daily on Day 2 through Day 14 of each 21 day cycle until disease progression or unacceptable toxicity developed up to 39 months.
426998|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426999|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
427000|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427001|NCT00550043|O1|Outcome|Placebo|
427002|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
427003|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
427004|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
427005|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427006|NCT00550043|O1|Outcome|Placebo|
426948|NCT00550147|B1|Baseline|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
426949|NCT00550147|P1|Participant Flow|OROS Methylphenidate and Quetiapine|This is the Baseline Visit, immediately after enrollment and prior to taking any medication. All enrolled subjects start taking OROS methylphenidate until Visit 5. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study; 2 subjects were withdrawn from the study prior to visit 5. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm. Visit 10 is measured at the end of OROS MPH+Quetiapine treatment
426950|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+Quetiapine after Week 13
426951|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after week 4
426952|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426953|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426954|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH Monotherapy after Week 4
426955|NCT00550147|O1|Outcome|Baseline|Baseline scores at Study Entry
426956|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426957|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426958|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426959|NCT00550147|O3|Outcome|Visit 10 - MPH + Quetiapine - Week 13|Score following treatment with MPH+quetiapine after Week 13
426960|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426961|NCT00550147|O1|Outcome|Baseline|Baseline scores at study entry
426962|NCT00550147|O3|Outcome|Visit 10 - MPH+Quetiapine - Week 13|Score following treatment with combined MPH and quetiapine after Week 13
426963|NCT00550147|O2|Outcome|Visit 5 - MPH Monotherapy - Week 4|Score following treatment with MPH monotherapy after Week 4
426964|NCT00550147|O1|Outcome|Baseline|Baseline score at study entry
426965|NCT00550147|E1|Reported Event|OROS Methylphenidate and Quetiapine|All enrolled subjects start taking OROS methylphenidate. At visit 5, if there is significant improvement (decrease in aggressive symptoms), then subject is discontinued from the study. If there is not significant improvement, then subject continues in study and begins taking OROS methylphenidate plus quetiapine. Therefore enters the OROS methylphenidate and quetiapine arm. 24 of 30 subjects entered the OROS methylphenidate and quetiapine arm. 4 subjects made significant improvement at visit 5 and were discontinued from the study, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. 2 subjects were withdrawn from the study prior to visit 5, and, therefore, did not enter the OROS methylphenidate and quetiapine arm. Therefore, 6 of 30 subjects did not enter the OROS methylphenidate and quetiapine arm. Only 24 of 30 subjects entered this arm.
426966|NCT00550043|B6|Baseline|Total|Total of all reporting groups
426967|NCT00550043|B5|Baseline|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426968|NCT00550043|B4|Baseline|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426969|NCT00550043|B3|Baseline|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426970|NCT00550043|B2|Baseline|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426971|NCT00550043|B1|Baseline|Placebo|
426972|NCT00550043|P5|Participant Flow|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426973|NCT00550043|P4|Participant Flow|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426974|NCT00550043|P3|Participant Flow|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426975|NCT00550043|P2|Participant Flow|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426976|NCT00550043|P1|Participant Flow|Placebo|
426977|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426978|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426979|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426980|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426981|NCT00550043|O1|Outcome|Placebo|
426982|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426983|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426984|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426985|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426986|NCT00550043|O1|Outcome|Placebo|
426987|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426988|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426989|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426990|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426991|NCT00550043|O1|Outcome|Placebo|
426992|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
426993|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
426994|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
426995|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
426996|NCT00550043|O1|Outcome|Placebo|
427014|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
427015|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427016|NCT00550043|O1|Outcome|Placebo|
427017|NCT00550043|O5|Outcome|Cohort 2: Treatment Group D|INCB018424 50 mg QD
427018|NCT00550043|O4|Outcome|Cohort 2: Treatment Group C|INCB018424 25 mg BID
427019|NCT00550043|O3|Outcome|Cohort 2: Treatment Group B|INCB018424 5 mg BID
427020|NCT00550043|O2|Outcome|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427021|NCT00550043|O1|Outcome|Placebo|
427022|NCT00550043|E5|Reported Event|Cohort 2: Treatment Group D|INCB018424 50 mg QD
427023|NCT00550043|E4|Reported Event|Cohort 2: Treatment Group C|INCB018424 25 mg BID
427024|NCT00550043|E3|Reported Event|Cohort 2: Treatment Group B|INCB018424 5 mg BID
427025|NCT00550043|E2|Reported Event|Cohort 1: Treatment Group A|INCB018424 15 mg BID
427026|NCT00550043|E1|Reported Event|Placebo|
427027|NCT00549939|B4|Baseline|Total|Total of all reporting groups
427028|NCT00549939|B3|Baseline|Alfuzosin 0.2 mg/kg/Day|
427029|NCT00549939|B2|Baseline|Alfuzosin 0.1 mg/kg/Day|
427030|NCT00549939|B1|Baseline|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
427031|NCT00549939|P3|Participant Flow|Alfuzosin 0.2 mg/kg/Day|
427032|NCT00549939|P2|Participant Flow|Alfuzosin 0.1 mg/kg/Day|
427033|NCT00549939|P1|Participant Flow|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
427034|NCT00549939|O2|Outcome|Alfuzosin 0.2 mg/kg/Day|
427035|NCT00549939|O1|Outcome|Alfuzosin 0.1 mg/kg/Day|
427036|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427037|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427038|NCT00549939|O1|Outcome|Placebo|
427039|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427040|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427041|NCT00549939|O1|Outcome|Placebo|
427042|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427043|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427044|NCT00549939|O1|Outcome|Placebo|
427045|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427046|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427047|NCT00549939|O1|Outcome|Placebo|
427048|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427049|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427050|NCT00549939|O1|Outcome|Placebo|
427051|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427052|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427053|NCT00549939|O1|Outcome|Placebo|
427054|NCT00549939|O3|Outcome|Alfuzosin 0.2 mg/kg/Day|
427055|NCT00549939|O2|Outcome|Alfuzosin 0.1 mg/kg/Day|
427056|NCT00549939|O1|Outcome|Placebo|Alfuzosin 0.1 mg/kg/day matching placebo or Alfuzosin 0.2 mg/kg/day matching placebo
427057|NCT00549939|E2|Reported Event|Alfuzosin 0.2 mg/kg/Day|
427058|NCT00549939|E1|Reported Event|Alfuzosin 0.1 mg/kg/Day|
427059|NCT00549900|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427060|NCT00549900|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427061|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427062|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427063|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427064|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427065|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427066|NCT00549900|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427067|NCT00549900|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK580299 vaccine (Cervarix™, HPV -16/18 L1 VLP AS04 vaccine) according to a 0, 1, 6-month schedule.
427068|NCT00549783|B3|Baseline|Total|Total of all reporting groups
427069|NCT00549783|B2|Baseline|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427070|NCT00549783|B1|Baseline|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427071|NCT00549783|P2|Participant Flow|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427072|NCT00549783|P1|Participant Flow|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427073|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427074|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427075|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427076|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427077|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427078|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427079|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427080|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427081|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427082|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427083|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427084|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427085|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427086|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427087|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427088|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427089|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427090|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427091|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427092|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427093|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427094|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427095|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427096|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427097|NCT00549783|O2|Outcome|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427098|NCT00549783|O1|Outcome|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427099|NCT00549783|E2|Reported Event|Placebo|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427100|NCT00549783|E1|Reported Event|Botulinum Toxin Type A 900kD|First intra-muscular injection at the Baseline visit, and optional second injection of the randomised treatment after a minimum of 12 weeks to a maximum of 24 weeks following the Baseline visit.
427101|NCT00549770|B9|Baseline|Total|Total of all reporting groups
427102|NCT00549770|B8|Baseline|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427103|NCT00549770|B7|Baseline|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427104|NCT00549770|B6|Baseline|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427105|NCT00549770|B5|Baseline|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427106|NCT00549770|B4|Baseline|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427107|NCT00549770|B3|Baseline|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427108|NCT00549770|B2|Baseline|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427109|NCT00549770|B1|Baseline|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427110|NCT00549770|P8|Participant Flow|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427111|NCT00549770|P7|Participant Flow|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427112|NCT00549770|P6|Participant Flow|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427113|NCT00549770|P5|Participant Flow|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427114|NCT00549770|P4|Participant Flow|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427115|NCT00549770|P3|Participant Flow|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427116|NCT00549770|P2|Participant Flow|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427117|NCT00549770|P1|Participant Flow|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427118|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427119|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427120|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427121|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427122|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427123|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427124|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427125|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427126|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427127|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427128|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427129|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427130|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427131|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427132|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427133|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427134|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427135|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427136|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427137|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427138|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427139|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427140|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427141|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427142|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427143|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
428099|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
427144|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427145|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427146|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427147|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427148|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427149|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427150|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427151|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427152|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427153|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427154|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427155|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427156|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427157|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427158|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427159|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427160|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427161|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427162|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427163|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427164|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427165|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427166|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427167|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427168|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427169|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427170|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427171|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427172|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427173|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427174|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427175|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427176|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427177|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427178|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427179|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427180|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427181|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427182|NCT00549770|O8|Outcome|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427183|NCT00549770|O7|Outcome|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427184|NCT00549770|O6|Outcome|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427185|NCT00549770|O5|Outcome|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427186|NCT00549770|O4|Outcome|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427187|NCT00549770|O3|Outcome|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427188|NCT00549770|O2|Outcome|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427189|NCT00549770|O1|Outcome|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427190|NCT00549770|E8|Reported Event|Placebo|Participants received matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427191|NCT00549770|E7|Reported Event|AHU377 200 mg|Participants received AHU377 200 mg and matching placebo to LCZ696 and Valsartan (5 tablets and 2 capsules) daily.
427192|NCT00549770|E6|Reported Event|Valsartan 320 mg|Participants received Valsartan 320 mg (160 mg valsartan capsules for one week followed by 320 mg valsartan capsules for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427193|NCT00549770|E5|Reported Event|Valsartan 160 mg|Participants received Valsartan 160 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427194|NCT00549770|E4|Reported Event|Valsartan 80 mg|Participants received Valsartan 80 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427195|NCT00549770|E3|Reported Event|LCZ696 400 mg|Participants received LCZ696 400 mg (200 mg LCZ696 for one week and then up-titration to 400 mg LCZ696 for 7 weeks) and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427196|NCT00549770|E2|Reported Event|LCZ696 200 mg|Participants received LCZ696 200 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427197|NCT00549770|E1|Reported Event|LCZ696 100 mg|Participants received LCZ696 100 mg and matching placebo to LCZ696, Valsartan and AHU377 (5 tablets and 2 capsules) daily.
427198|NCT00549757|B3|Baseline|Total|Total of all reporting groups
427199|NCT00549757|B2|Baseline|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
427200|NCT00549757|B1|Baseline|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
427201|NCT00549757|P2|Participant Flow|Placebo|"In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
427202|NCT00549757|P1|Participant Flow|Aliskiren|"In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.~With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment."
427203|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427204|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427205|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427206|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427334|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427207|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427208|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427209|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427210|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427211|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427212|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427213|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427214|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427215|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427216|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427217|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427218|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427219|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427220|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427221|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427222|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427223|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427224|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427225|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427226|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427227|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427228|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427229|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427230|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427231|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427542|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427232|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427233|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427234|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427235|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427236|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427237|NCT00549757|O2|Outcome|Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427238|NCT00549757|O1|Outcome|Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427239|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427240|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427241|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427242|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427243|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427244|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427245|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427246|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427247|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427248|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427249|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427250|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427543|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427251|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427252|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427253|NCT00549757|O2|Outcome|Placebo|In Core (Double Blind) phase, placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427254|NCT00549757|O1|Outcome|Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427255|NCT00549757|E4|Reported Event|Extension-phase: Placebo|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427256|NCT00549757|E3|Reported Event|Extension-phase: Aliskiren|With the recommendation of Data Monitoring Committee (DMC), after discontinuation of study drug, a follow up was added as Extension Phase (9 months in average) with no active treatment.
427257|NCT00549757|E2|Reported Event|Core-phase: Placebo|In Core (Double Blind) Phase, Placebo to match aliskiren 150 mg once daily (o.d.) for 4 weeks; from Visit 5/Week 4 placebo to match aliskiren 300 mg o.d. (or placebo to match aliskiren 150 mg if patient could not tolerate target dose of study drug). Visits took place 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until final closure of the study.
427258|NCT00549757|E1|Reported Event|Core-phase: Aliskiren|In Core (Double Blind) phase, Aliskiren 150 mg once daily (o.d.) for 4 weeks; then patient was uptitrated to 300 mg o.d. at Visit 5/Week 4 (or 150 mg o.d. if patient could not tolerate target dose of study drug). Visits took place at 1, 4 , 5, 8 and 12 weeks after randomization (Visit 3/Week 0). Subsequent visits were planned every three months until end of core phase.
427259|NCT00549718|B5|Baseline|Total|Total of all reporting groups
427260|NCT00549718|B4|Baseline|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427261|NCT00549718|B3|Baseline|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
427262|NCT00549718|B2|Baseline|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427263|NCT00549718|B1|Baseline|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
427264|NCT00549718|P4|Participant Flow|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427265|NCT00549718|P3|Participant Flow|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
427266|NCT00549718|P2|Participant Flow|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427267|NCT00549718|P1|Participant Flow|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
427268|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427269|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
427270|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427271|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
427272|NCT00549718|O4|Outcome|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427273|NCT00549718|O3|Outcome|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
427274|NCT00549718|O2|Outcome|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427275|NCT00549718|O1|Outcome|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
427276|NCT00549718|E4|Reported Event|Placebo|Matching placebo to Lurasidone 40 mg taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427277|NCT00549718|E3|Reported Event|Lurasidone 120mg|Lurasidone 40 mg tablets taken once/day
427278|NCT00549718|E2|Reported Event|Lurasidone 80mg|lurasidone 40m mg tablets taken once/day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 4 subjects were randomized but never received a dose of study drug.
427279|NCT00549718|E1|Reported Event|Lurasidone 40mg|Lurasidone 40 mg tablets taken once a day The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (500). The number of subjects in the baseline characteristics is based on the safety population (489). All randomized subjects who received at least one dose of study medication were included in the safety analysis. This means that 3 subjects were randomized but never received a dose of study drug.
427280|NCT00549640|B3|Baseline|Total|Total of all reporting groups
427281|NCT00549640|B2|Baseline|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427282|NCT00549640|B1|Baseline|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427283|NCT00549640|P2|Participant Flow|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427284|NCT00549640|P1|Participant Flow|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427285|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427286|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427287|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427288|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427289|NCT00549640|O2|Outcome|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427290|NCT00549640|O1|Outcome|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427291|NCT00549640|E2|Reported Event|Placebo|Look alike placebo pill with same dosing schedule as active methylphenidate
427292|NCT00549640|E1|Reported Event|Methylphenidate|osmotic-release methylphenidate (OROS-MPH) at a dose of one 18 mg tablet a day with a dose escalation schedule in the first 2 weeks to achieve a maximum dose of 54 mg (three 18 mg tablets once daily)
427293|NCT00549601|B4|Baseline|Total|Total of all reporting groups
427294|NCT00549601|B3|Baseline|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427295|NCT00549601|B2|Baseline|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427296|NCT00549601|B1|Baseline|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427297|NCT00549601|P3|Participant Flow|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427298|NCT00549601|P2|Participant Flow|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
428100|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
427299|NCT00549601|P1|Participant Flow|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427300|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427301|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427302|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427303|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427304|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427305|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427306|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427307|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427308|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427309|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427310|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427311|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427312|NCT00549601|O2|Outcome|Rivastigmine 9.5 mg Patch|Rivastigmine transdermal patches at a constant dose: Application of one 9.5 mg patch every day for the whole treatment period.
427313|NCT00549601|O1|Outcome|Rivastigmine 4.6 mg/9.5 mg Patch|Rivastigmine transdermal patches at increasing doses: Application of one 4.6 mg patch every day for the first month of treatment and thereafter daily application of one 9.5 mg patch for the next two months.
427314|NCT00549601|O3|Outcome|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427315|NCT00549601|O2|Outcome|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427316|NCT00549601|O1|Outcome|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427317|NCT00549601|E3|Reported Event|Rivastigmine Capsules (6 mg to 12 mg/Day)|Rivastigmine administered orally, following the same regime as prior to randomization (doses between 6 mg and 12 mg/day), which remained unchanged throughout the 3 months of treatment.
427318|NCT00549601|E2|Reported Event|Rivastigmine Patch (9.5 mg/Day)|Rivastigmine administered transdermally via patches at a constant dose (9.5 mg/day for the 3 months of treatment).
427319|NCT00549601|E1|Reported Event|Rivastigmine Patch (4.6 mg/Day Switch to 9.5 mg/Day)|Rivastigmine administered transdermally via patches at increasing doses (1 patch/day of 4.6 mg for the first month, changing to 1 patch/day of 9.5 mg for the remaining two months).
427320|NCT00549549|B5|Baseline|Total|Total of all reporting groups
427321|NCT00549549|B4|Baseline|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427322|NCT00549549|B3|Baseline|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427323|NCT00549549|B2|Baseline|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427324|NCT00549549|B1|Baseline|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427325|NCT00549549|P4|Participant Flow|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427326|NCT00549549|P3|Participant Flow|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427327|NCT00549549|P2|Participant Flow|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427328|NCT00549549|P1|Participant Flow|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427329|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427330|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427331|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427332|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427333|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427335|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427336|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427337|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427338|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427339|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427340|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427341|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427342|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427343|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427344|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427345|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427346|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427347|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427348|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427349|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427350|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427351|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427352|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427353|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427354|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427355|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427356|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427357|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427358|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427359|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427360|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427361|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427362|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427363|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427364|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427365|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427366|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427367|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427368|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427369|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427370|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427371|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427372|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427373|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427374|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427375|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427376|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427377|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427378|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427379|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427380|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427381|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427382|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427383|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427384|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427385|NCT00549549|O4|Outcome|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427386|NCT00549549|O3|Outcome|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427387|NCT00549549|O2|Outcome|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427388|NCT00549549|O1|Outcome|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427389|NCT00549549|E4|Reported Event|Indomethacin 50 mg|Indomethacin 50 mg three times daily for 8 days.
427390|NCT00549549|E3|Reported Event|Celecoxib 800/400 mg|An initial dose of celecoxib 800 mg followed by a second dose of 400 mg 12 hours later on Day 1 (celecoxib 800/400 mg regimen) and continuing 400 mg twice daily for 7 days.
427391|NCT00549549|E2|Reported Event|Celecoxib 400/200 mg|An initial dose of celecoxib 400 mg followed by a second dose of 200 mg 12 hours later on Day 1 (celecoxib 400/200 mg regimen) and continuing 200 mg twice daily for 7 days.
427392|NCT00549549|E1|Reported Event|Celecoxib 50 mg|Participants received Celecoxib 50 mg twice daily for 8 days
427393|NCT00549393|B3|Baseline|Total|Total of all reporting groups
427394|NCT00549393|B2|Baseline|Control Arm|Standard bathing with soap and water basin or disposable cloth
427395|NCT00549393|B1|Baseline|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427396|NCT00549393|P2|Participant Flow|Standard Bath|Standard bathing with soap and water basin or disposable cloth
427397|NCT00549393|P1|Participant Flow|2% Chlorhexidine Gluconate Cloth|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427398|NCT00549393|O2|Outcome|Standard Bathing|Standard bathing with soap and water basin or disposable cloth
427399|NCT00549393|O1|Outcome|Chlorhexidine Bathing|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427400|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
427401|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427402|NCT00549393|O2|Outcome|Control Arm|Standard bathing with soap and water basin or disposable cloth
427403|NCT00549393|O1|Outcome|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427404|NCT00549393|E2|Reported Event|Control Arm|Standard bathing with soap and water basin or disposable cloth
427405|NCT00549393|E1|Reported Event|Treatment Arm|"Daily bathing with 2% chlorhexidine gluconate~2% Chlorhexidine gluconate cloth: Daily bathing"
427406|NCT00549328|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427407|NCT00549328|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427408|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427409|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427410|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427411|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427412|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427413|NCT00549328|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427414|NCT00549328|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) monotherapy given orally once daily
427415|NCT00549302|B3|Baseline|Total|Total of all reporting groups
427416|NCT00549302|B2|Baseline|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
427417|NCT00549302|B1|Baseline|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
427418|NCT00549302|P3|Participant Flow|Tadalafil 40 mg Open-Label|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Week 53 up to Week 243.
427419|NCT00549302|P2|Participant Flow|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
427420|NCT00549302|P1|Participant Flow|Tadalafil 20 mg Double Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
427421|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
427422|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
427423|NCT00549302|O2|Outcome|Tadalafil 40 mg|Tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment.
428101|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
427424|NCT00549302|O1|Outcome|Tadalalfil 20 Milligrams (mg)|Tadalafil, 20 milligram (mg) tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment; LOCF.
427425|NCT00549302|O2|Outcome|Tadalafil 40 mg Double-Blind|Tadalafil, 40 mg (two 20 mg tablets) administered orally once daily from Day 1 up to 52 weeks of treatment.
427426|NCT00549302|O1|Outcome|Tadalafil 20 Milligrams (mg) Double-Blind|Tadalafil, 20 milligram (mg) administered orally as 1 tadalafil tablet and 1 matched placebo tablet once daily from Day 1 up to 52 weeks of treatment.
427427|NCT00549302|O1|Outcome|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg tablets administered orally as one tablet tadalafil and one tablet matched placebo once per day from Day 1 up to 52 weeks of treatment or tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Day 1 up to 52 weeks of treatment in Double-blind period; and tadalafil, two 20 mg tablets (40 mg total) administered orally once per day from Week 53 up to Week 243 in Open-label period.
427428|NCT00549302|E1|Reported Event|Tadalafil 20 mg or 40 mg Double-Blind and 40 mg Open-Label|Tadalafil 20 mg administered orally as 1 tadalafil 20-mg tablet and 1 matched placebo tablet, once daily from Day 1 up to 52 weeks of treatment, or tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Day 1 up to 52 weeks of treatment in Double-Blind Period; and tadalafil 40 mg (two 20-mg tablets) administered orally, once daily from Week 53 up to Week 243 in Open-Label Period.
427429|NCT00547534|B1|Baseline|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
427430|NCT00547534|P1|Participant Flow|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
427431|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
427432|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated
427433|NCT00547534|O1|Outcome|Lymphoma Subjects|Subjects that met all eligibility criteria and were treated.
427434|NCT00547534|E1|Reported Event|Lymphoma Subjects|Subjects that met all eligibility criteria and were given study treatment.
427435|NCT00547521|B3|Baseline|Total|Total of all reporting groups
427436|NCT00547521|B2|Baseline|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427437|NCT00547521|B1|Baseline|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427438|NCT00547521|P2|Participant Flow|SC Abatacept Cohort|In the ST period, participants in this cohort were administered monotherapy, a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During the LTE, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE period, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. LTE period pooled all participants into 1 arm. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
427439|NCT00547521|P1|Participant Flow|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427440|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427441|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427442|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427443|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427444|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427544|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427445|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427446|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
427447|NCT00547521|O1|Outcome|Abatacept Monotherapy Subgroup|Abatacept Monotherapy Subgroup was defined as those participants who received as at least 1 dose of abatacept and did not receive MTX in the ST and LTE Studies.
427448|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427449|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427450|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427451|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427452|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427453|NCT00547521|O1|Outcome|Abatacept Long Term Extension Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition.
427454|NCT00547521|O1|Outcome|Abatacept Long Term Extension (LTE) Study|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator’s discretion based upon the participant’s clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant’s clinical condition. Participation in the LTE continued until the abatacept SC formulation was commercially available in the country or until the study was terminated by the sponsor.
427455|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427456|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427457|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427458|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427459|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
427460|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
427461|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427462|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427463|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427464|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427465|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427466|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427467|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427468|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427469|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly. Participants did not receive MTX at screening ie, MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept. During LTE period, all eligible participants continued to self administer abatacept (125 mg SC) on a weekly basis.
427470|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept. During LTE period, adjustments to MTX were permitted at the investigator’s discretion based upon the participant’s clinical status.
427471|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427472|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427473|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427474|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427475|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427476|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427477|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427478|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427479|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427480|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427481|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427545|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
428102|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
427482|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427483|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427484|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427485|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427486|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427487|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427488|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427489|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427490|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427491|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427492|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427493|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427494|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427495|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427496|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427497|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427498|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427499|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427500|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427501|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427502|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
428103|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
427503|NCT00547521|O2|Outcome|SC Abatacept Monotherapy Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427504|NCT00547521|O1|Outcome|Subcutaneous (SC) Abatacept + Methotrexate (MTX) Cohort|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427505|NCT00547521|E3|Reported Event|Long Term Extension (LTE):125 mg SC Abatacept|During the LTE Study, all eligible participants continued to self-administer abatacept (125 mg SC) on a weekly basis with or without background MTX. During the LTE Study, adjustments to RA medications (other than prohibited therapies), including MTX, were permitted at the investigator's discretion based upon the participant's clinical status. Consideration was given to decreasing corticosteroids and MTX in the presence of improvement in the participant's clinical condition.
427506|NCT00547521|E2|Reported Event|Short Term Study: SC Abatacept Monotherapy|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants did not receive MTX at screening i.e., MTX naive, or discontinued MTX due to lack of efficacy or tolerability at least 4 weeks prior to first injection of SC abatacept.
427507|NCT00547521|E1|Reported Event|Short Term Study: Subcutaneous (SC) Abatacept + Methotrexate|In the ST period, participants were administered a dose of 125 mg abatacept SC, once weekly, for 4 months. Participants were also administered a stable MTX dose of greater than or equal to 10 mg once weekly for at least 4 weeks prior to first injection of SC abatacept.
427508|NCT00549198|B3|Baseline|Total|Total of all reporting groups
427509|NCT00549198|B2|Baseline|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427510|NCT00549198|B1|Baseline|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427511|NCT00549198|P2|Participant Flow|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427512|NCT00549198|P1|Participant Flow|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427513|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427514|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427515|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427516|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427517|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427518|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427519|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427520|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427521|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427522|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427523|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427524|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427525|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427526|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427527|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427528|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427529|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427530|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427531|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427532|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427533|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427534|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427535|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427536|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427537|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427538|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427539|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427540|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427541|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427546|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427547|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427548|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427549|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427550|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427551|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427552|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427553|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427554|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427555|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427556|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427557|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427558|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427559|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427560|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427561|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427562|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427563|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427564|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427565|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427566|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427567|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427568|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427569|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427570|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427571|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427572|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427573|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427574|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427575|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427576|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427577|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427578|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427579|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427580|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427581|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427582|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427583|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427584|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427585|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427586|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427587|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427588|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427589|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427590|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427591|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427592|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427593|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427594|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427595|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427596|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427597|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427598|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427599|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427600|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427601|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427602|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427603|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427604|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427605|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427606|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427607|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427608|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427609|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427610|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427611|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427612|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427613|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427614|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427615|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427616|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427617|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427618|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427619|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427620|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427621|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427622|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427623|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427624|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427625|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427626|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427627|NCT00549198|O2|Outcome|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427628|NCT00549198|O1|Outcome|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427629|NCT00549198|E2|Reported Event|TDF/FTC FDC|Tenofovir (TDF) 300 mg/emtricitabine (FTC) 200 mg FDC once daily (QD) plus 600 mg efavirenz QD
427630|NCT00549198|E1|Reported Event|ABC/3TC FDC|Abacavir (ABC) 600 mg/lamivudine (3TC) 300 mg fixed dose combination (FDC) once daily (QD) plus 600 mg efavirenz QD
427631|NCT00549172|B3|Baseline|Total|Total of all reporting groups
427632|NCT00549172|B2|Baseline|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427633|NCT00549172|B1|Baseline|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427634|NCT00549172|P2|Participant Flow|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427635|NCT00549172|P1|Participant Flow|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427636|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
428104|NCT00546871|O5|Outcome|Study Extension, SC Administration|
427637|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427638|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427639|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427640|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427641|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427642|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427643|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427644|NCT00549172|O2|Outcome|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy~n=76"
427645|NCT00549172|O1|Outcome|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus~n=70"
427646|NCT00549172|E2|Reported Event|Conservative (K)|"Arthroscopy (diagnostic)~Conservative (diagnostic arthroscopy): Diagnostic arthroscopy"
427647|NCT00549172|E1|Reported Event|Operative (O)|"Partial resection of degenerative tear of medial meniscus~Operative (partial arthroscopy): Partial arthroscopic resection of degenerative rupture of the medial meniscus"
427648|NCT00549055|B1|Baseline|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427649|NCT00549055|P1|Participant Flow|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427650|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427651|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427652|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427653|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427654|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427655|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427656|NCT00549055|O1|Outcome|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427657|NCT00549055|E1|Reported Event|Macugen|Intraocular injections of Macugen into the treated eye. The use and dosage recommendations for Macugen took place on the basis of the approved package insert.
427658|NCT00548886|B1|Baseline|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
427659|NCT00548886|P1|Participant Flow|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
427660|NCT00548886|O1|Outcome|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
427661|NCT00548886|E1|Reported Event|Epinephrine|Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.
427662|NCT00548860|B3|Baseline|Total|Total of all reporting groups
427663|NCT00548860|B2|Baseline|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
427664|NCT00548860|B1|Baseline|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
427665|NCT00548860|P2|Participant Flow|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
427666|NCT00548860|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
427667|NCT00548860|O2|Outcome|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
427668|NCT00548860|O1|Outcome|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
427669|NCT00548860|E2|Reported Event|Standard Medical Care (SMC)|SMC for postpartum and heavy uterine bleeding subjects with anemia
427670|NCT00548860|E1|Reported Event|Ferric Carboxymaltose (FCM)|Intravenous (IV) iron
427671|NCT00548847|B1|Baseline|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
427716|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427672|NCT00548847|P1|Participant Flow|GM-CSF, Interferon-α-2b|Granulocyte-macrophage colony-stimulating factor (GM-CSF), Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
427673|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
427674|NCT00548847|O1|Outcome|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m² Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
427675|NCT00548847|E1|Reported Event|GM-CSF, Interferon-α-2b|GM-CSF, Interferon-α-2b: Dosing schedule: GM-CSF, 250 mcg/m2 Mon-Wed-Fri; Pegylated Interferon-α-2b 1.5 mcg/kg Monday weekly. Response assessed between 2 and 4 weeks. Duration on study is 3 months.
427676|NCT00548808|B3|Baseline|Total|Total of all reporting groups
427677|NCT00548808|B2|Baseline|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427678|NCT00548808|B1|Baseline|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427679|NCT00548808|P2|Participant Flow|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427680|NCT00548808|P1|Participant Flow|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427681|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427682|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427683|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427684|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427685|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427686|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427687|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427688|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427689|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427690|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427691|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427692|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427693|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427694|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427695|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427696|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427697|NCT00548808|O2|Outcome|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427698|NCT00548808|O1|Outcome|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427699|NCT00548808|E2|Reported Event|Insulin Glargine|Insulin glargine (alone or with 1, 2 or 3 daily injections of insulin lispro)
427700|NCT00548808|E1|Reported Event|Insulin Lispro LM|Insulin lispro low mixture (1, 2 or 3 daily injections)
427701|NCT00548717|B3|Baseline|Total|Total of all reporting groups
427702|NCT00548717|B2|Baseline|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427703|NCT00548717|B1|Baseline|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
427704|NCT00548717|P2|Participant Flow|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib for GVHD prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF) Bortezomib (Velcade)~*Bortezomib added when study reopened in November 2012"
427705|NCT00548717|P1|Participant Flow|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin) Mycophenolate Mofetil (MMF)"
427706|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427707|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
427708|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil,and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427709|NCT00548717|O1|Outcome|Siro /MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
427710|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427711|NCT00548717|O1|Outcome|Siro/MMF|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);"
427712|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427713|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
427714|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427715|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
427717|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
427718|NCT00548717|O2|Outcome|Siro/MMF/Bort|"Sirolimus, Mycophenolate Mofetil, and Bortezomib as GVHD Prophylaxis~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);Bortezomib (Velcade) *added with study reopening in 2012"
427719|NCT00548717|O1|Outcome|Siro/MMF|Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF);
427720|NCT00548717|E1|Reported Event|Siro/MMF (+/- Bortezomib)|"Sirolimus and Mycophenolate Mofetil as GVHD Prophylaxis (+/- Bortezomib)~Sirolimus (Rapamycin); Mycophenolate Mofetil (MMF); Bortezomib (Velcade) *added with study reopening in 2012"
427721|NCT00548691|B3|Baseline|Total|Total of all reporting groups
427722|NCT00548691|B2|Baseline|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
427723|NCT00548691|B1|Baseline|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
427724|NCT00548691|P2|Participant Flow|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
427725|NCT00548691|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
427726|NCT00548691|O2|Outcome|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
427727|NCT00548691|O1|Outcome|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
427728|NCT00548691|E2|Reported Event|Standard Medical Care (SMC)|SMC for IDA (as determined by the Investigator) for treating CKD related anemia.
427729|NCT00548691|E1|Reported Event|Ferric Carboxymaltose (FCM)|Subjects received an undiluted dose of iron as FCM IV (15 mg/kg up to a maximum of 1000 mg) or subjects received 200 mg of FCM IV push undiluted directly into the venous line of the dialyzer.
427730|NCT00548548|B3|Baseline|Total|Total of all reporting groups
427731|NCT00548548|B2|Baseline|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427732|NCT00548548|B1|Baseline|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427733|NCT00548548|P2|Participant Flow|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427734|NCT00548548|P1|Participant Flow|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427735|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427736|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427737|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427738|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427739|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427740|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
428105|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
427741|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427742|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427743|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427744|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427745|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427746|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427747|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427748|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427749|NCT00548548|O2|Outcome|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427750|NCT00548548|O1|Outcome|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427751|NCT00548548|E2|Reported Event|Placebo|Participants received intravenous (IV) placebo infusion every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. The placebo and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427752|NCT00548548|E1|Reported Event|Bevacizumab|Participants received intravenous (IV) bevacizumab 7.5 mg/kg every 3 weeks, oral capecitabine 1,000 mg/m˄2 twice daily for 14 days every 3 weeks, or 5-fluorouracil (5-FU) at a dose of 800 mg/m˄2/day as a continuous IV infusion over the first 5 days of every 3 week cycle, and cisplatin 80 mg/m˄2 as an IV infusion every 3 weeks for a maximum of 6 cycles. Bevacizumab and capecitabine/5-FU were administered until disease progression or unacceptable toxicity.
427753|NCT00547456|B1|Baseline|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
427754|NCT00547456|P1|Participant Flow|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
427755|NCT00547456|O1|Outcome|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
427756|NCT00547456|E1|Reported Event|Decrease in Oxygen Level When Sleeping|"Patients are their own controls and tested pre and post the addition of night time supplemental oxygen~Oxygen: Oxygen 2-3L Nasal cannula"
427757|NCT00547365|B1|Baseline|Human Immune Globulin Intravenous (IGIV)|
427758|NCT00547365|P1|Participant Flow|Human Immune Globulin Intravenous (IGIV)|The therapeutic potential of human immune globulin intravenous (IGIV)was evaluated in patients with cardiac-associated AL amyloidosis. Patients received, via intravenous infusion, 30-40 gm of IGIV (depending on body weight) weekly for 3 months and then every other week for the next 9 months.The total time to complete the study was ~1 yr.
427788|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427759|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Human immune globulin intravenous (IGIV) was infused into 10 patients with cardiac-associated AL amyloidosis and its therapeutic potential evaluated through measurement of serum anti-fibril IgG antibody levels, as well as amyloid burden, pre- and post-administration.
427760|NCT00547365|O1|Outcome|Human Immune Globulin Intravenous (IGIV)|Immune globulin intravenous (IGIV) was administered to patients with cardiac-dominant AL amyloidosis in order to determine its therapeutic potential or possible toxicity when given to subjects weekly for 3 months and then every other week for the next 9 months. Response was evaluated by changes in serum anti-fibril antibody levels, changes in BNP (B-type natriuretic peptide) levels and IVS (interventricular septum) thickness.
427761|NCT00547365|E1|Reported Event|Human Immune Globulin Intravenous (IGIV)|Therapeutic potential of human immune globulin intravenous (IGIV)in patients with cardiac-associated AL amyloidosis
427762|NCT00548431|B1|Baseline|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
427763|NCT00548431|P1|Participant Flow|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
427764|NCT00548431|O1|Outcome|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
427765|NCT00548431|E1|Reported Event|6-mercaptopurine|All patients received basic 6-mercaptopurine and in addition high-dose methotrexate(HDM) at 3 week intervals ((3 3-week intervals) in total) and PEG-asparaginase at 2 week intervals(5 dosis in total) . Patients received dose increments of 6-mercaptopurine 14 days after High-dose methotrexate if the myelotoxicity was acceptable
427766|NCT00548418|B1|Baseline|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427767|NCT00548418|P1|Participant Flow|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427768|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427769|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427770|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427771|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427772|NCT00548418|O1|Outcome|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427773|NCT00548418|E1|Reported Event|Treatment (Cisplatin, Topotecan, Bevacizumab)|"Cisplatin 50 mg/m2 IV day 1 of a 21 day cycle~Topotecan 0.75 mg/m2 IV Days 1, 2, 3 of a 21 day cycle~Bevacizumab 15 mg/kg day 1 of a 21 day cycle"
427774|NCT00548405|B4|Baseline|Total|Total of all reporting groups
427775|NCT00548405|B3|Baseline|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
427776|NCT00548405|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion over 4 hours on 3 consecutive days at Month 12.
427777|NCT00548405|B1|Baseline|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427778|NCT00548405|P3|Participant Flow|Alemtuzumab 24mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
427779|NCT00548405|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427780|NCT00548405|P1|Participant Flow|Interferon Beta-1a|Interferon Beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427781|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427782|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427783|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427784|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427785|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427786|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427787|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
428106|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
427789|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427790|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427791|NCT00548405|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427792|NCT00548405|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427793|NCT00548405|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg or 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg or 24 mg per day IV infusion on 3 consecutive days at Month 12.
427794|NCT00548405|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 24 mg per day IV infusion on 3 consecutive days at Month 12.
427795|NCT00548405|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
427796|NCT00548405|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
427797|NCT00548340|B4|Baseline|Total|Total of all reporting groups
427798|NCT00548340|B3|Baseline|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427799|NCT00548340|B2|Baseline|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427800|NCT00548340|B1|Baseline|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427801|NCT00548340|P3|Participant Flow|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427802|NCT00548340|P2|Participant Flow|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427803|NCT00548340|P1|Participant Flow|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427804|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427805|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427806|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427807|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427808|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427809|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427810|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427811|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427812|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427813|NCT00548340|O3|Outcome|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427814|NCT00548340|O2|Outcome|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427815|NCT00548340|O1|Outcome|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427816|NCT00548340|E3|Reported Event|Placebo|Placebo: Placebo capsules, PO daily for five weeks
427817|NCT00548340|E2|Reported Event|VEC-162 50 mg|VEC-162: 50 mg VEC-162 capsules, PO daily for five weeks
427818|NCT00548340|E1|Reported Event|VEC-162 20 mg|VEC-162: 20 mg VEC-162 capsules, PO daily for five weeks
427819|NCT00548327|B3|Baseline|Total|Total of all reporting groups
427820|NCT00548327|B2|Baseline|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427821|NCT00548327|B1|Baseline|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427822|NCT00548327|P2|Participant Flow|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427823|NCT00548327|P1|Participant Flow|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427846|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427824|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427825|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427826|NCT00548327|O2|Outcome|Patients With Schizophrenia|
427827|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
427828|NCT00548327|O2|Outcome|Patients With Schizophrenia|
427829|NCT00548327|O1|Outcome|Healthy Participants|Atomoxetine 40 mg twice daily (bid), placebo, Val/Val, Val/Met, Met/Met.
427830|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427831|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427832|NCT00548327|O2|Outcome|Patients With Schizophrenia|
427833|NCT00548327|O1|Outcome|Healthy Participants|
427834|NCT00548327|O2|Outcome|Patients With Schizophrenia|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in patients with schizophrenia. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427835|NCT00548327|O1|Outcome|Healthy Participants|"This is a double-blind, placebo-control, cross-over study of Atomoxetine in healthy volunteers. It includes 3 genotypes, the VAL/VAL, VAL/MET and MET/MET. Subjects are 2 weeks on placebo, 2 weeks on active compound and one week wash-out period between arms.~Amoxetine schedule: 25 mg Day 1 (or Day 22), 40 mg Day 2-3 (or Days 23-24), 60 mg Days 4-5 (or Days 25-26), 80 mg Days 6-14 (or Days 27-35).~Placebo schedule: Atomoxetine 25 mg Placebo Day 1 (or Day 22), Atomoxetine 40 mg Placebo Day 2-3 (or Days 23-24), Atomoxetine 60 mg Placebo Days 4-5 (or Days 25-26), Atomoxetine 80 mg Placebo Days 6-14 (or Days 27-35)."
427836|NCT00548327|E4|Reported Event|Placebo-Healthy Volunteer|
427837|NCT00548327|E3|Reported Event|Atomoxetine-Healthy Volunteer|
427838|NCT00548327|E2|Reported Event|Placebo-Patient|
427839|NCT00548327|E1|Reported Event|Atomoxetine-Patient|
427840|NCT00548262|B1|Baseline|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427841|NCT00548262|P1|Participant Flow|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427842|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427843|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427844|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427845|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427847|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427848|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427849|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427850|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427851|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427852|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427853|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427854|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427855|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427856|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427857|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427858|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427859|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427860|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427861|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427862|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427863|NCT00548262|O1|Outcome|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427909|NCT00548249|E2|Reported Event|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427864|NCT00548262|E1|Reported Event|Anidulafungin-Voriconazole|Anidulafungin 200 milligrams (mg) intravenously (IV) on Day 1, then once daily 100 mg IV beginning on Day 2. Participants who complete a minimum of 5 days of IV anidulafungin could be switched to oral (PO) voriconazole (loading dose of 400 mg twice daily [BID] or 200 mg BID if body weight < 40 kilograms [kg] and then 200 mg BID or 100 mg BID if body weight < 40 kg thereafter.
427865|NCT00548249|B6|Baseline|Total|Total of all reporting groups
427866|NCT00548249|B5|Baseline|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427867|NCT00548249|B4|Baseline|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427868|NCT00548249|B3|Baseline|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427869|NCT00548249|B2|Baseline|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427870|NCT00548249|B1|Baseline|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427871|NCT00548249|P5|Participant Flow|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427872|NCT00548249|P4|Participant Flow|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427873|NCT00548249|P3|Participant Flow|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427874|NCT00548249|P2|Participant Flow|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427875|NCT00548249|P1|Participant Flow|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427876|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427877|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427878|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427879|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427880|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427881|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427882|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427883|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427884|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427885|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427886|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427887|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427888|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427889|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427890|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427891|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427892|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427893|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427894|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427895|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427896|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427897|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427898|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427899|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427900|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427901|NCT00548249|O5|Outcome|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427902|NCT00548249|O4|Outcome|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427903|NCT00548249|O3|Outcome|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427904|NCT00548249|O2|Outcome|5 µg Iron/dL of Dialysate|5 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427905|NCT00548249|O1|Outcome|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427906|NCT00548249|E5|Reported Event|15 µg Iron/dL of Dialysate|15 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427907|NCT00548249|E4|Reported Event|12 µg Iron/dL of Dialysate|12 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427908|NCT00548249|E3|Reported Event|10 µg Iron/dL of Dialysate|10 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
428107|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
427910|NCT00548249|E1|Reported Event|0 µg Iron/dL of Dialysate|Placebo; 0 micrograms (µg) iron/deciliter (dL) of dialysate during dialysis 3 times/ week
427911|NCT00548184|B1|Baseline|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
427912|NCT00548184|P1|Participant Flow|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and Trastuzumab 4mg/kg loading dose and then 2mg/kg every week
427913|NCT00548184|O1|Outcome|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trauzumab 4mg/kg loading dose and then 2mg/kg every week
427914|NCT00548184|E1|Reported Event|Lapatinib + Trastuzumab|All study participants received lapatinib 1000mg daily and trastuzumab 4mg/kg loading dose and then 2mg/kg every week
427915|NCT00548145|B3|Baseline|Total|Total of all reporting groups
427916|NCT00548145|B2|Baseline|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
427917|NCT00548145|B1|Baseline|Pitavastatin|2 mg by orally/day Duration: 12 months
427918|NCT00548145|P2|Participant Flow|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
427919|NCT00548145|P1|Participant Flow|Pitavastatin|2 mg by orally/day Duration: 12 months
427920|NCT00548145|O2|Outcome|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
427921|NCT00548145|O1|Outcome|Pitavastatin|2 mg by orally/day Duration: 12 months
427922|NCT00548145|E2|Reported Event|Cholesterol-lowering Medicine Other Than Statin|duration: 12 months
427923|NCT00548145|E1|Reported Event|Pitavastatin|2 mg by orally/day Duration: 12 months
427924|NCT00548132|B3|Baseline|Total|Total of all reporting groups
427925|NCT00548132|B2|Baseline|Chlorhexidine-impregnated Foam Dressing|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
427926|NCT00548132|B1|Baseline|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
427927|NCT00548132|P2|Participant Flow|Chlorhexidine-impregnated Foam Dressing|
427928|NCT00548132|P1|Participant Flow|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
427929|NCT00548132|O2|Outcome|Intervention Group|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
427930|NCT00548132|O1|Outcome|Standard of Care|Standard catheter care-use of chlorhexidine-alcohol solution to prep the catheter site and then a bioocclusive dressing is applied
427931|NCT00548132|O2|Outcome|Chlorhexidine Impregnated Sponge|Patients in this group had the Biopatch applied on the catheter exit site after insertion of the catheter. Dressings were changed every 7 days along with the Biopatch after the skin was cleaned with a chlorhexidine-alcohol antiseptic solution. Dressings were assessed daily and changed if they were soiled, non-intact, or bloody before the 7-day period was up.
427932|NCT00548132|O1|Outcome|Standard of Care|Standard of care
427933|NCT00548132|E2|Reported Event|Chlorhexidine-impregnated Foam Dressing|
427934|NCT00548132|E1|Reported Event|Standard of Care|Patients in this arm will continue to get the standard catheter care protocol without the use of the chlorhexidine-impregnated foam dressing.
427935|NCT00548041|B1|Baseline|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
427936|NCT00548041|P1|Participant Flow|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
427937|NCT00548041|O1|Outcome|Subjects Undergoing Rapid HIV Testing in the ED|Subjects were seen in the ED and had rapid HIV testing performed.
427938|NCT00548041|E1|Reported Event|Subjects Undergoing HIV Testing in the ED|
427939|NCT00547911|B5|Baseline|Total|Total of all reporting groups
427940|NCT00547911|B4|Baseline|Parkinson's Disease|Subjects with autonomic failure and a history of Parkinson's Disease
427941|NCT00547911|B3|Baseline|Multiple System Atrophy|Subjects with autonomic failure and a history of Multiple System Atrophy
427942|NCT00547911|B2|Baseline|Pure Autonomic Failure|Subjects with Pure Autonomic Failure
427943|NCT00547911|B1|Baseline|Healthy Volunteer|Subjects in good general health
427944|NCT00547911|P6|Participant Flow|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
427945|NCT00547911|P5|Participant Flow|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
427946|NCT00547911|P4|Participant Flow|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
427947|NCT00547911|P3|Participant Flow|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
427948|NCT00547911|P2|Participant Flow|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
427949|NCT00547911|P1|Participant Flow|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
427950|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427951|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427952|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427953|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427954|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427955|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427956|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427957|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427958|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427959|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427960|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of placebo
427961|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427962|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427963|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427964|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427965|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427966|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427967|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427968|NCT00547911|O3|Outcome|LDOPS + ENT|Orally received 400 mg of droxidopa after 200 mg of entacapone
427969|NCT00547911|O2|Outcome|LDOPS + CAR|Orally received 400 mg of droxidopa after 200 mg of carbidopa
427970|NCT00547911|O1|Outcome|LDOPS + Placebo|Orally received 400 mg of droxidopa after 200 mg of placebo
427971|NCT00547911|E6|Reported Event|LDOPS + ENT; LDOPS + CAR; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + CAR, and lastly LDOPS + Placebo.
427972|NCT00547911|E5|Reported Event|LDOPS + ENT; LDOPS + Placebo; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + ENT, followed by LDOPS + Placebo, and lastly LDOPS + CAR.
427973|NCT00547911|E4|Reported Event|LDOPS + CAR; LDOPS + ENT; LDOPS + Placebo|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + ENT, and lastly LDOPS + Placebo.
427974|NCT00547911|E3|Reported Event|LDOPS + CAR; LDOPS + Placebo; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + CAR, followed by LDOPS + Placebo, and lastly LDOPS + ENT.
428021|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428022|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
427975|NCT00547911|E2|Reported Event|LDOPS + Placebo; LDOPS + Ent; LDOPS + CAR|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + ENT, and lastly LDOPS + CAR.
427976|NCT00547911|E1|Reported Event|LDOPS + Placebo; LDOPS + CAR; LDOPS + ENT|There are three interventions that every subject orally received over the duration of the study; 400 mg of droxidopa (LDOPS) + 200 mg placebo, 400 mg of droxidopa (LDOPS) + 200 mg carbidopa (CAR), and 400 mg of droxidopa (LDOPS) + 200 mg entacapone (ENT). The order of the three interventions was randomly assigned prior to drug administration and each intervention was followed by a wash out period of at least two days to clear previous intervention from subject’s systems. This arm received the three interventions in the order of: LDOPS + Placebo, followed by LDOPS + CAR, and lastly LDOPS + ENT.
427977|NCT00547157|B3|Baseline|Total|Total of all reporting groups
427978|NCT00547157|B2|Baseline|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427979|NCT00547157|B1|Baseline|Panitumumab Plus Radiotherpy|Consists of Panitumumab and Radiotherpy
427980|NCT00547157|P2|Participant Flow|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427981|NCT00547157|P1|Participant Flow|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427982|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427983|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427984|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427985|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427986|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427987|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427988|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427989|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427990|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427991|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427992|NCT00547157|O2|Outcome|Chemoradiotherapy|Cisplatin (100 mg/m2 day 1 and day 22) plus Accelerated Fractionation Radiotherapy
427993|NCT00547157|O1|Outcome|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427994|NCT00547157|E2|Reported Event|Chemotherapy Plus Radiotherapy|
427995|NCT00547157|E1|Reported Event|Panitumumab Plus Radiotherapy|Panitumumab (9.0 mg/kg day 1, day 22, day 43) plus Accelerated Fractionation Radiotherapy
427996|NCT00547118|B3|Baseline|Total|Total of all reporting groups
427997|NCT00547118|B2|Baseline|Placebo|"Placebo~Placebo: Placebo"
427998|NCT00547118|B1|Baseline|Rimonabant|"Rimonabant~Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days."
427999|NCT00547118|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
428000|NCT00547118|P1|Participant Flow|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
428001|NCT00547118|O2|Outcome|Placebo|"Placebo~Placebo: Placebo"
428002|NCT00547118|O1|Outcome|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
428003|NCT00547118|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo"
428004|NCT00547118|E1|Reported Event|Rimonabant|Rimonabant: Rimonabant, 1 20 mg tablet given 1 time per day for 112 days.
428005|NCT00546910|B3|Baseline|Total|Total of all reporting groups
428006|NCT00546910|B2|Baseline|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428007|NCT00546910|B1|Baseline|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428008|NCT00546910|P2|Participant Flow|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428009|NCT00546910|P1|Participant Flow|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428010|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428011|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428012|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428013|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428014|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428015|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428016|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428017|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428018|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428019|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428020|NCT00546910|O2|Outcome|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428023|NCT00546910|O1|Outcome|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428024|NCT00546910|E2|Reported Event|Placebo|Placebo matched to 1 week lead-in and 7 week standard target dose of atomoxetine
428025|NCT00546910|E1|Reported Event|Atomoxetine|0.5 milligram per kilogram (mg/kg) per day lead-in dose for 1 weeks followed by 7 weeks at 1.2 mg/kg per day dose.
428026|NCT00546897|B3|Baseline|Total|Total of all reporting groups
428027|NCT00546897|B2|Baseline|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428028|NCT00546897|B1|Baseline|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428029|NCT00546897|P2|Participant Flow|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428030|NCT00546897|P1|Participant Flow|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428031|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428032|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428033|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428034|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428035|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428036|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428088|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428089|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428090|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428091|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
428092|NCT00546871|O5|Outcome|Study Extension, SC Administration|
428093|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
428037|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428038|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428039|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428040|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428041|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428042|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428043|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428044|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428045|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428046|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428047|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428048|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428049|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428050|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428051|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428052|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428053|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428054|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428055|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428056|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428057|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428058|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428059|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428060|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428061|NCT00546897|O2|Outcome|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428062|NCT00546897|O1|Outcome|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428063|NCT00546897|E2|Reported Event|Cohort 2|"Cycle 1: Oral lenalidomide 50 mg/day x 28 days induction therapy. Treatment will then depend on the response to Cycle 1: if patients obtain a complete remission (CR) they will proceed to low dose lenalidomide therapy, if patients have a non-CR they will receive a second high dose cycle of lenalidomide 50 mg/day x 28 days (Cycle 2) Cycle 2 consists of lenalidomide 50mg/day x 28 days Further treatment will depend on the response to Cycle 2: if patients obtain a CR/partial remission (PR)/stable disease (SD) they will proceed to low dose lenalidomide therapy, if patients have PD they will be removed from the study.~Low Dose Cycles: low dose lenalidomide therapy consisting of 10 mg daily for a 28 day cycle.be 1) For patients that achieve a CR, 2 cycles of low dose lenalidomide will be administered, and then patients observed off therapy. For patients with PR/SD, low dose lenalidomide will continue for a total of 6 cycles and then patients will be observed off therapy."
428064|NCT00546897|E1|Reported Event|Cohort 1|"Lenalidomide 50 mg/day oral for 14 days followed by 30 days of rest. Lenalidomide 50 mg/day oral for 21 days (this is Cycle 1 and Cycle 2).~If no progressive disease (PD) then lenalidomide 10 mg/day oral for 28 days for 12 cycles."
428065|NCT00546871|B1|Baseline|Treated Participants|
428066|NCT00546871|P2|Participant Flow|12 Years and Older|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
428067|NCT00546871|P1|Participant Flow|2 to <12 Years|"Part 1: IV infusions of IGIV, 10% (every 3 or 4 weeks) for 12 weeks at dose/schedule prior to study (300 - 1,000 mg/kg/4 weeks). Pharmacokinetic (PK) done on ≥12 years after 3rd or 4th infusion Part 2: Weekly subcutaneous (SC) IGIV, 10% at 130% of weekly equivalent dose in Part 1 for ≥12 weeks, until 15 subjects ≥ 12years completed PK assessment. PK determined Adjusted Dose in Part 3a Part 3a: 6 weeks SC IGIV Adjusted Dose. Trough levels determined at Week 5 to see if increase in trough levels was not within 15% of expected increase, then dose was individually adapted~Part 3b: Participants received weekly SC infusions for 12 weeks. Dose administered was determined as follows:~If trough levels within 15% of expected over trough level determined in Part 1, dosing remained same as Part 3a~If trough levels not within 15% of expected over trough level in Part 1, participants received Individually Adapted Dose Study Extension: Participants were offered to enter into Extension"
428068|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428069|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428070|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428071|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
428072|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
428073|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
428074|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
428075|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped
428076|NCT00546871|O1|Outcome|Infusion Rate Change (Percentage) - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped. Percentage of Infusions with a change in the infusion rate.
428077|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
428078|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
428079|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428080|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428081|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428082|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428083|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428084|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428085|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428086|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428087|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428108|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
428109|NCT00546871|O6|Outcome|Total SC (Study Parts 2, 3a, 3b, Extension)|
428110|NCT00546871|O5|Outcome|Study Extension, SC Administration|
428111|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
428112|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
428113|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
428114|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
428115|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
428116|NCT00546871|O5|Outcome|Study Extension, SC Administration|
428117|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
428118|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
428119|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
428120|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
428121|NCT00546871|O6|Outcome|Total SC (Parts 2, 3a, 3b, Extension)|
428122|NCT00546871|O5|Outcome|Study Extension, SC Administration|
428123|NCT00546871|O4|Outcome|Study Part 3b, SC Administration|
428124|NCT00546871|O3|Outcome|Study Part 3a, SC Administration|
428125|NCT00546871|O2|Outcome|Study Part 2, SC Administration|
428126|NCT00546871|O1|Outcome|Study Part 1, IV Administration|
428127|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
428128|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
428129|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428130|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428131|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428132|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428133|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428134|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428135|NCT00546871|O3|Outcome|SESC|Dataset of participants with prior experience with subcutaneous administration of immunoglobulins
428136|NCT00546871|O2|Outcome|SNSC|Dataset of participants naïve to SC administration of immunoglobulins
428137|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428138|NCT00546871|O3|Outcome|SESC|Dataset of subjects with prior experience with subcutaneous administration of immunoglobulins
428139|NCT00546871|O2|Outcome|SNSC|Dataset of subjects naïve to SC administration of immunoglobulins
428140|NCT00546871|O1|Outcome|FSDS|All participants who received any study drug
428141|NCT00546871|O2|Outcome|All SC Treatment Periods|Study Parts 2, 3a, 3b, extension
428142|NCT00546871|O1|Outcome|IV Treatment|Study Part 1
428143|NCT00546871|O2|Outcome|12 Years and Older|
428144|NCT00546871|O1|Outcome|2 to <12 Years|
428145|NCT00546871|O1|Outcome|Full Safety Data Set|
428146|NCT00546871|O1|Outcome|All Participants|
428147|NCT00546871|O2|Outcome|Infusion Rate Change - For Tolerability/AE|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Tolerability/AEs
428148|NCT00546871|O1|Outcome|Infusion Rate Change - For Any Reason|Infusion Rate Reduced and/or Infusion Interrupted or Stopped for Any Reason
428149|NCT00546871|O1|Outcome|All Participants|
428150|NCT00546871|O1|Outcome|All Participants|
428151|NCT00546871|O1|Outcome|12 Years and Older|
428152|NCT00546871|O1|Outcome|12 Years and Older|
428153|NCT00546871|O1|Outcome|12 Years and Older|
428154|NCT00546871|O1|Outcome|12 Years and Older|
428155|NCT00546871|O1|Outcome|12 Years and Older|
428156|NCT00546871|O1|Outcome|12 Years and Older|
428157|NCT00546871|O1|Outcome|12 Years and Older|
428158|NCT00546871|O1|Outcome|12 Years and Older|
428159|NCT00546871|O1|Outcome|12 Years and Older|
428160|NCT00546871|O1|Outcome|12 Years and Older|
428161|NCT00546871|O1|Outcome|12 Years and Older|
428162|NCT00546871|O1|Outcome|12 Years and Older|
428163|NCT00546871|O1|Outcome|12 Years and Older|
428164|NCT00546871|O1|Outcome|12 Years and Older|
428165|NCT00546871|O1|Outcome|Participants Aged 2 to <12 Years|
428166|NCT00546871|O1|Outcome|Participants ≥12 Years Old With PK Data Part 1 and Part 3b|"IV infusions of IGIV, 10% (every 3 or 4 weeks, ± 2 days) for 12 weeks at dose and schedule they were on prior to study (300 to 1,000 mg/kg/4 weeks).~SC dosing for Study Part 3b was determined by:~From Study Part 2, PK: Participants received weekly (± 1 day) SC IGIV at a dose of 130% of weekly equivalent of IV dose. First 15 participants ≥12 years to complete PK were used to determine the Adjusted Dose.~Study Part 3a, Adjusted Dose: Participants treated SC for 6 weeks using Adjusted Dose. If Adjusted Dose did not achieve expected trough levels, dose was adjusted to an Individually Adapted Dose to ensure sufficient trough levels.~Study Part 3b:~Participants received weekly SC infusions for 12 weeks. Dose administered was either:~The Adjusted Dose~Individually Adapted Dose"
428167|NCT00546871|E2|Reported Event|SC Treatment Period|Study Parts 2, 3a, 3b, and Extension
428168|NCT00546871|E1|Reported Event|IV Treatment Period|Study Part 1
428169|NCT00546819|B3|Baseline|Total|Total of all reporting groups
428170|NCT00546819|B2|Baseline|Placebo|Participants administered Placebo on Day 1.
428171|NCT00546819|B1|Baseline|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428172|NCT00546819|P2|Participant Flow|Placebo|Participants administered Placebo on Day 1.
428173|NCT00546819|P1|Participant Flow|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428174|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
428175|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428176|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
428177|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428178|NCT00546819|O2|Outcome|Placebo|Participants administered Placebo on Day 1.
428179|NCT00546819|O1|Outcome|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428180|NCT00546819|E2|Reported Event|Placebo|Participants administered Placebo on Day 1.
428181|NCT00546819|E1|Reported Event|ZOSTAVAX™|Participants administered ZOSTAVAX™ on Day 1.
428182|NCT00546754|B3|Baseline|Total|Total of all reporting groups
428183|NCT00546754|B2|Baseline|Valsartan 80 mg/HCTZ 12.5 mg|"Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~373 – number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
428184|NCT00546754|B1|Baseline|Losartan 50 mg/HCTZ 12.5 mg|"Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.~416 number of patients that received at least one dose of study medication and had 1 follow-up visit (intent-to-treat population [ITT])"
428185|NCT00546754|P2|Participant Flow|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428186|NCT00546754|P1|Participant Flow|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428187|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428188|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428189|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428190|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428191|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428192|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428193|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428194|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428195|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428196|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428197|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428198|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428199|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428200|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428201|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428202|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428203|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428204|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428205|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428206|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428207|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428208|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428209|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428210|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428211|NCT00546754|O2|Outcome|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428212|NCT00546754|O1|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
429162|NCT00545025|B3|Baseline|Total|Total of all reporting groups
428213|NCT00546754|E2|Reported Event|Valsartan 80 mg/HCTZ 12.5 mg|Patients could be titrated up from valsartan 80 mg/HCTZ 12.5 mg to valsartan 160 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428214|NCT00546754|E1|Reported Event|Losartan 50 mg/HCTZ 12.5 mg|Patients could be titrated up from losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg to losartan 100 mg/HCTZ 25 mg only if needed to achieve target blood pressure.
428215|NCT00546728|B3|Baseline|Total|Total of all reporting groups
428216|NCT00546728|B2|Baseline|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
428217|NCT00546728|B1|Baseline|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
428218|NCT00546728|P2|Participant Flow|Metformin|Three months of Metformin. Metformin was initiated at a dose of 500 mg, twice a day for one month and up titrated to 1000 mg, twice a day for the remaining two months.
428219|NCT00546728|P1|Participant Flow|Exenatide|Three months of Exenatide. Exenatide was initiated at a dose of 5 mcg, twice a day for one month and up titrated to 10 mcg, twice a day for the remaining two months.
428220|NCT00546728|O2|Outcome|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
428221|NCT00546728|O1|Outcome|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
428222|NCT00546728|E2|Reported Event|Metformin|Three months of Metformin therapy. Metformin was initiated at 500 mcg, twice a day for one month and then up titrated to 1000 mcg, twice a day for the remaining two months.
428223|NCT00546728|E1|Reported Event|Exenatide|Three months of Exenatide therapy. Exenatide was initiated at 5 mcg, twice a day for one month and then up titrated to 10 mcg, twice a day for the remaining two months.
428224|NCT00546715|B5|Baseline|Total|Total of all reporting groups
428225|NCT00546715|B4|Baseline|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428226|NCT00546715|B3|Baseline|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428227|NCT00546715|B2|Baseline|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428228|NCT00546715|B1|Baseline|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428229|NCT00546715|P4|Participant Flow|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428230|NCT00546715|P3|Participant Flow|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428231|NCT00546715|P2|Participant Flow|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428232|NCT00546715|P1|Participant Flow|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428233|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428234|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428235|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428236|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428237|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428238|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428239|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428240|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428241|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428242|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428243|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428244|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428245|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428246|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428247|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428248|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428249|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428250|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428251|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428252|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428253|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428254|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428255|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428256|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428257|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428258|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428259|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428260|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428261|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428262|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428263|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428264|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428265|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428266|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428267|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428268|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428269|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428270|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428271|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428272|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428273|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428274|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428275|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428276|NCT00546715|O4|Outcome|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428277|NCT00546715|O3|Outcome|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428278|NCT00546715|O2|Outcome|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
429852|NCT00542386|E5|Reported Event|MCI-196: 15 g|MCI-196: 15 g/ day
428279|NCT00546715|O1|Outcome|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428280|NCT00546715|E4|Reported Event|Placebo|Participants received single dose of placebo matched to daclatasvir daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428281|NCT00546715|E3|Reported Event|Daclatasvir-100 mg|Participants received single dose of daclatasvir 100 mg as oral solution at concentration of 50 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428282|NCT00546715|E2|Reported Event|Daclatasvir-10 mg|Participants received single dose of daclatasvir 10 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428283|NCT00546715|E1|Reported Event|Daclatasvir-1 mg|Participants received single dose of daclatasvir 1 mg as oral solution at concentration of 1 mg/mL daily, after fasting for at least 10 hours pre-dose and 4 hours post-dose.
428284|NCT00546637|B3|Baseline|Total|Total of all reporting groups
428285|NCT00546637|B2|Baseline|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428286|NCT00546637|B1|Baseline|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428287|NCT00546637|P2|Participant Flow|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428288|NCT00546637|P1|Participant Flow|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428289|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428290|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428291|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428292|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428293|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428294|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428295|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428296|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428483|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
429853|NCT00542386|E4|Reported Event|MCI-196: 12 g|MCI-196: 12 g/ day
428297|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428298|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428299|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428300|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428301|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428302|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428303|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428304|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428305|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428306|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428307|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428308|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428309|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428310|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428396|NCT00546572|E8|Reported Event|23vPS / 13vPnC 6-M FU (Vax 2 / Year 1)|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose at Year 1 (Vax 2); events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
428397|NCT00546572|E7|Reported Event|13vPnC / 13vPnC 6-M FU (Vax 2 / Year 1)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2) ; events assessed at 6-M FU (Vax 2 / Year 1) telephone visit to report new events.
428311|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428312|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428313|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428314|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428315|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428316|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428317|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428318|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428319|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428320|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428321|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428322|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428323|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428324|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428398|NCT00546572|E6|Reported Event|23vPS / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=62; systematic (solicited) Local Reactions N=189; systematic (solicited) Systemic Events N=174."
429854|NCT00542386|E3|Reported Event|MCI-196: 9 g|MCI-196: 9 g/ day
428325|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428326|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428327|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428328|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428329|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428330|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428331|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428332|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428333|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428334|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428335|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428336|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428337|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428338|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428399|NCT00546572|E5|Reported Event|13vPnC / 13vPnC (Vax 2 / Year 1) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=69; systematic (solicited) Local Reactions N=191; systematic (solicited) Systemic Events N=161."
429855|NCT00542386|E2|Reported Event|MCI-196: 6 g|MCI-196: 6 g/ day
428339|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428340|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428341|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428342|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428343|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428344|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428345|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428346|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428347|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428348|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428349|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428350|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428351|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428352|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428400|NCT00546572|E4|Reported Event|23vPS 6-M FU (Vax 1 / Year 0)|23vPS 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-M FU (Vax 1 / Year 0) telephone visit to report new events.
428401|NCT00546572|E3|Reported Event|13vPnC 6-M FU (Vax 1 / Year 0)|13vPnC 0.5 mL dose IM at Year 0 (Vax 1); events assessed at 6-Month Follow-up visit (6-M FU) (Vax 1 / Year 0) telephone visit to report new events.
428353|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428354|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428355|NCT00546637|O2|Outcome|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428356|NCT00546637|O1|Outcome|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428357|NCT00546637|E2|Reported Event|Placebo|Subjects were initially treated with placebo once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, the matching placebo for fesoterodine 8 mg tablets was provided to those in the placebo group who choose the dose increase. For the rest of subjects, the dose was maintained at matching placebo.
428358|NCT00546637|E1|Reported Event|Fesoterodine 4mg or 8mg|Subjects initially treated with fesoterodine 4 mg once-daily for 4 weeks. At Week 4 visit, the dose of study drug was adjusted through collaborative decision by the investigator and the subject. For those subjects who desired greater symptom improvement and reported acceptable safety and tolerability, fesoterodine dose was increased to 8 mg in a blinded fashion. For the rest of subjects, the dose was maintained at fesoterodine 4 mg.
428359|NCT00546572|B3|Baseline|Total|Total of all reporting groups
428360|NCT00546572|B2|Baseline|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428361|NCT00546572|B1|Baseline|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428362|NCT00546572|P2|Participant Flow|23vPS / 13vPnC|23-valent pneumococcal polysaccharide conjugate vaccine (23vPS) 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
428363|NCT00546572|P1|Participant Flow|13vPnC / 13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliters (mL) dose intramuscularly (IM) at Year 0 (vaccination 1 [Vax 1]) and 13vPnC 0.5 mL IM at Year 1 (Vax 2)
428364|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428365|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428366|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax )
428367|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428368|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428369|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428370|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428371|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428372|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428373|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428374|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428375|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428376|NCT00546572|O2|Outcome|23vPS / 13vPnC|23vPS 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428377|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428378|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428379|NCT00546572|O1|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428380|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428381|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428382|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428383|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428384|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428385|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428386|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428387|NCT00546572|O1|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428388|NCT00546572|O2|Outcome|13vPnC / 13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1) and 13vPnC 0.5 mL dose IM at Year 1 (Vax 2)
428389|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428390|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428391|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428392|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428393|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428394|NCT00546572|O2|Outcome|23vPS|23vPS 0.5 mL dose IM at Year 0 (Vax 1)
428395|NCT00546572|O1|Outcome|13vPnC|13vPnC 0.5 mL dose IM at Year 0 (Vax 1)
428402|NCT00546572|E2|Reported Event|23vPS (Vax 1 / Year 0) 1 Month After Vaccination|"23vPS 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=83; systematic (solicited) Local Reactions N=248; systematic (solicited) Systemic Events N=275."
428403|NCT00546572|E1|Reported Event|13vPnC (Vax 1 / Year 0) 1 Month After Vaccination|"13vPnC 0.5 mL dose IM at Year 0 (Vax 1)~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=66; systematic (solicited) Local Reactions N=209; systematic (solicited) Systemic Events N=234."
428404|NCT00546481|B3|Baseline|Total|Total of all reporting groups
428405|NCT00546481|B2|Baseline|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428406|NCT00546481|B1|Baseline|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428407|NCT00546481|P3|Participant Flow|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
428408|NCT00546481|P2|Participant Flow|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428409|NCT00546481|P1|Participant Flow|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428410|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428411|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428412|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428413|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428414|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428415|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428416|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
428417|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428418|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428419|NCT00546481|O3|Outcome|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined criteria in protocol) IV once every 4 weeks for the subsequent 24 weeks.
428420|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428421|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428422|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428423|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428424|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428425|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428426|NCT00546481|O2|Outcome|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428427|NCT00546481|O1|Outcome|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428428|NCT00546481|E3|Reported Event|Maintenance Phase: CERA|Eligible participants who achieved a hemoglobin target range of level >=11.0 g/dL at least once during the correction phase (Week 1 to Week 24) without RBC transfusion and completed correction phase treatment, moved to Maintenance phase wherein they were administered CERA (dose adjusted according to the predefined protocol) IV once every 4 weeks for the subsequent 24 weeks.
428429|NCT00546481|E2|Reported Event|Correction Phase: Epoetin Beta|Eligible participants were administered Epoetin beta IV three times per week at the starting dose of 40 IU/kg for 24 weeks.
428430|NCT00546481|E1|Reported Event|Correction Phase: CERA|Eligible participants were administered CERA IV once every 2 weeks at the starting dose of 0.6 μg/kg for 24 weeks.
428431|NCT00546429|B1|Baseline|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
428432|NCT00546429|P1|Participant Flow|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
428481|NCT00546351|P1|Participant Flow|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428433|NCT00546429|O1|Outcome|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
428434|NCT00546429|E1|Reported Event|DePuy Orthopaedics ATN Trochanteric Nail System|The participants in this study will undergo treatment of trochanteric fractures using DePuy Orthopaedics ATN Trochanteric Nail System implants and results will be reviewed by clinical and radiographic evaluations.
428435|NCT00546377|B1|Baseline|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
428436|NCT00546377|P1|Participant Flow|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
428437|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
428438|NCT00546377|O1|Outcome|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
428439|NCT00546377|E1|Reported Event|Pentostatin,Cyclophosphamide,Rituximab & Mitoxantrone|To determine the dose of mitoxantrone that can be safely administered with pentostatin, cyclosphosphamide, and rituximab in previously treated patient with CLL and other low grade B-cell malignancies.
428440|NCT00546364|B4|Baseline|Total|Total of all reporting groups
428441|NCT00546364|B3|Baseline|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428442|NCT00546364|B2|Baseline|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428443|NCT00546364|B1|Baseline|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428444|NCT00546364|P3|Participant Flow|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428445|NCT00546364|P2|Participant Flow|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428446|NCT00546364|P1|Participant Flow|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428447|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428448|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428449|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428450|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428451|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428452|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428453|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428454|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428455|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428482|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
429856|NCT00542386|E1|Reported Event|MCI-196: 3 g|MCI-196: 3 g/ day
428456|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428457|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428458|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428459|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428460|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428461|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428462|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428463|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428464|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428465|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428466|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428467|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428468|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428469|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428470|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428471|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428472|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428473|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428474|NCT00546364|O3|Outcome|Docetaxel, 75 mg/m^2 + Capecitabine, 1000 mg/m^2|Docetaxel, 75 mg/m^2, administered as a 1-hour IV infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428475|NCT00546364|O2|Outcome|Ixabepilone, 32 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 32 mg/m^2, administered as a 3-hour IV continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428476|NCT00546364|O1|Outcome|Ixabepilone, 40 mg/m^2 + Capecitabine, 1000 mg/m^2|Ixabepilone, 40 mg/m^2, administered as a 3-hour intravenous (IV) continuous infusion on Day 1 of a 21-day cycle plus capecitabine, 1000 mg/m^2, given twice daily by mouth on Days 1 through 14 (±2 days) of each 21-day cycle, self-administered on an outpatient basis.
428477|NCT00546364|E3|Reported Event|Ixabepilone 40|
428478|NCT00546364|E2|Reported Event|Ixabepilone 32|
428479|NCT00546364|E1|Reported Event|Docetaxel|
428480|NCT00546351|B1|Baseline|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428484|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428485|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428486|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428487|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428488|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428489|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428490|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428491|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428492|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428493|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428494|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428495|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428496|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428497|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428498|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428499|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428500|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428501|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428502|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428503|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428504|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428505|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428506|NCT00546351|O1|Outcome|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428507|NCT00546351|E1|Reported Event|Lacosamide|50 to 100 mg Lacosamide film-coated tablets; two times per day up to 600 mg/day; 6.5 years.
428508|NCT00546273|B6|Baseline|Total|Total of all reporting groups
428509|NCT00546273|B5|Baseline|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
428510|NCT00546273|B4|Baseline|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
428511|NCT00546273|B3|Baseline|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
428512|NCT00546273|B2|Baseline|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
428513|NCT00546273|B1|Baseline|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
428514|NCT00546273|P5|Participant Flow|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
428515|NCT00546273|P4|Participant Flow|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
428516|NCT00546273|P3|Participant Flow|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
428517|NCT00546273|P2|Participant Flow|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
428518|NCT00546273|P1|Participant Flow|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
428519|NCT00546273|O5|Outcome|Placebo|placebo of the vaccine RUTI, given subcutaneously twice, on days 0 and 28
428520|NCT00546273|O4|Outcome|RUTI 200 Micrograms of FCMtb|RUTI dose: 200 micrograms of FCMtb
428521|NCT00546273|O3|Outcome|RUTI 100 Micrograms of FCMtb|RUTI dose: 100 micrograms of FCMtb
428522|NCT00546273|O2|Outcome|RUTI 25 Micrograms of FCMtb|RUTI dose: 25 micrograms of FCMtb
428523|NCT00546273|O1|Outcome|RUTI 5 Micrograms of FCMtb|RUTI dose: 5 micrograms of FCMtb
428524|NCT00546260|B3|Baseline|Total|Total of all reporting groups
428525|NCT00546260|B2|Baseline|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428526|NCT00546260|B1|Baseline|Placebo|Placebo Comparator
428527|NCT00546260|P2|Participant Flow|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428528|NCT00546260|P1|Participant Flow|Placebo|Placebo Comparator
428529|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428530|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
428531|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428532|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
428533|NCT00546260|O2|Outcome|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428534|NCT00546260|O1|Outcome|Placebo|Placebo Comparator
428535|NCT00546260|E2|Reported Event|Experimental|Experimental Cohorts (10, 20, 40, 60 mg)
428536|NCT00546260|E1|Reported Event|Placebo|Placebo Comparator
428537|NCT00546156|B3|Baseline|Total|Total of all reporting groups
428538|NCT00546156|B2|Baseline|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
428539|NCT00546156|B1|Baseline|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
428540|NCT00546156|P2|Participant Flow|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
428541|NCT00546156|P1|Participant Flow|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
428542|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
428543|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
428544|NCT00546156|O2|Outcome|Triple Negative Breast Cancer Cohort|Hormone receptor negative, HER2 negative Cohort. Receive same drug protocol as Arm A.
428545|NCT00546156|O1|Outcome|HR+, HER2-|Patients with Hormone Receptor Positive, HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
428546|NCT00546156|E1|Reported Event|All Study Participants|Patients with HER2 negative Breast Cancer. A single dose of Bevacizumab 10mg/kg, followed two weeks later by Adriamycin60 mg/m2 and Cyclophosphamide 600 mg/m2 with Bevacizumab 10mg/kg every 2 weeks x4, followed by Taxol 175 mg/m2 with Bevacizumab 10 mg/kg every 2 weeks x3, followed by Taxol 175 mg/m2 x1.
428547|NCT00546117|B3|Baseline|Total|Total of all reporting groups
428548|NCT00546117|B2|Baseline|Placebo|Placebo SoluTab once daily for 2 months
428549|NCT00546117|B1|Baseline|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
428550|NCT00546117|P2|Participant Flow|Placebo|Placebo SoluTab once daily for 2 months
428551|NCT00546117|P1|Participant Flow|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
428552|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
428553|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
428554|NCT00546117|O2|Outcome|Placebo|Placebo SoluTab once daily for 2 months
428555|NCT00546117|O1|Outcome|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
428556|NCT00546117|E2|Reported Event|Placebo|Placebo SoluTab once daily for 2 months
428557|NCT00546117|E1|Reported Event|Prevacid|Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months
428558|NCT00546104|B1|Baseline|Dasatinib|50-100mg by mouth twice a day
428559|NCT00546104|P1|Participant Flow|Dasatinib|50-100 mg PO BID
428560|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428561|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428562|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428563|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428564|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428565|NCT00546104|O1|Outcome|Dasatinib|50mg-100mg po BID
428566|NCT00546104|E1|Reported Event|Dasatinib|50-100mg po bid
428567|NCT00546078|B3|Baseline|Total|Total of all reporting groups
428568|NCT00546078|B2|Baseline|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428569|NCT00546078|B1|Baseline|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428570|NCT00546078|P2|Participant Flow|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428571|NCT00546078|P1|Participant Flow|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428572|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428573|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428574|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428575|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428576|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428577|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428578|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428579|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428580|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428581|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428582|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428583|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428584|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428585|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428586|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428587|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428588|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428589|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428590|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428591|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428592|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428593|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428594|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428595|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428596|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428597|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428598|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428599|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428600|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428601|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428602|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428603|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428604|NCT00546078|O2|Outcome|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428605|NCT00546078|O1|Outcome|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428606|NCT00546078|E2|Reported Event|Cervarix™ 3-Dose Group|Subjects who had received 3 doses of placebo in study 580299/001 (NCT00689741), received 3 doses of Cervarix™ (Day 0, Month 1 and Month 6) in the current study.
428607|NCT00546078|E1|Reported Event|Cervarix™ 4-Dose Group|Subjects who had received 3 doses of Cervarix™ in study 580299/001 (NCT00689741), received a 4th dose of Cervarix™ on Day 0 in the current study.
428608|NCT00546052|B1|Baseline|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
428609|NCT00546052|P1|Participant Flow|Losartan +/- Hydrochlorothiazide|Patients could be titrated up from Cozaar 50 mg to Cozaar 100mg to losartan 100 mg + Hydrochlorothiazide 12.5 mg and losartan 100mg/ Hydrochlorothiazide 25 mg, in sequence at any subsequent visits only if needed to obtain Blood Pressure under 140/90 mm Hg.
428610|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428611|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428612|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428613|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428614|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428615|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428616|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428617|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428618|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428619|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428620|NCT00546052|O3|Outcome|Overall Per Protocol|All patients completing the 52 week study follow up.
428621|NCT00546052|O2|Outcome|Overall Intend to Treat|All patients enrolled and receiving at least one dose of study drug and having at least one follow up visit.
428622|NCT00546052|O1|Outcome|Overall Total|All patients enrolled (signed the informed consent).
428623|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428624|NCT00546052|O1|Outcome|Losartan +/- Hydrochlorothiazide|Patients that completed 52 weeks of treatment and were >= 80% compliant with the study medication.
428625|NCT00546052|E1|Reported Event|Overall ITT|
428626|NCT00546000|B1|Baseline|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
428627|NCT00546000|P1|Participant Flow|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
428628|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
428629|NCT00546000|O1|Outcome|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
428630|NCT00546000|E1|Reported Event|Experimental|"Receive between 22 and 29 days of Cutivate lotion treatment~Fluticasone propionate 0.05% lotion: Daily applications"
428631|NCT00545974|B3|Baseline|Total|Total of all reporting groups
428632|NCT00545974|B2|Baseline|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
428633|NCT00545974|B1|Baseline|Memantine|Memantine 10mg administered orally twice daily
428634|NCT00545974|P2|Participant Flow|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
428635|NCT00545974|P1|Participant Flow|Memantine|Memantine 10mg administered orally twice daily
428636|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
428637|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
428638|NCT00545974|O2|Outcome|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
428639|NCT00545974|O1|Outcome|Memantine|Memantine 10mg administered orally twice daily
428640|NCT00545974|E2|Reported Event|Placebo|Placebo (inactive tablets identical to memantine 10mg tablets)
428641|NCT00545974|E1|Reported Event|Memantine|Memantine 10mg administered orally twice daily
428642|NCT00545948|B4|Baseline|Total|Total of all reporting groups
428643|NCT00545948|B3|Baseline|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
428644|NCT00545948|B2|Baseline|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
428645|NCT00545948|B1|Baseline|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
428646|NCT00545948|P3|Participant Flow|Screen Failures|"Patients who were registered and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not assigned to or administered genomics-directed, protocol-based therapy.~Note that two patients who were assigned protocol-based treatment (1 in each arm) did not receive the treatment and were added to the 7 initially identified as screen failures within the summary of baseline characteristics and outcome measures."
428647|NCT00545948|P2|Participant Flow|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
428648|NCT00545948|P1|Participant Flow|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
428649|NCT00545948|O2|Outcome|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
428650|NCT00545948|O1|Outcome|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
428651|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
428652|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study.
428653|NCT00545948|O1|Outcome|All Registered Patients|All registered/enrolled patients are included in this outcome, which was measured at the time of consent.
428654|NCT00545948|O1|Outcome|Treatment|Treatment refers to patients treated in the combined vinorelbine and pemetrexed arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for primary outcome analysis.
428655|NCT00545948|E2|Reported Event|Arm B-Pemetrexed|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of pemetrexed sensitivity were given cisplatin + pemetrexed.
428656|NCT00545948|E1|Reported Event|Arm A-Vinorelbine|Resected tumor was used for genomic expression profiling. Patients with a genomic expression pattern suggestive of vinorelbine sensitivity were given cisplatin + vinorelbine.
428692|NCT00545766|E1|Reported Event|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
428693|NCT00545753|B4|Baseline|Total|Total of all reporting groups
428657|NCT00545844|B1|Baseline|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
428658|NCT00545844|P1|Participant Flow|All Patients|"montelukast sodium, 10 mg, one tablet once a day for 8 weeks as add on therapy to usual current asthma controller treatment~Patients with comorbid allergic rhinitis and uncontrolled asthma were invited to participate in the treatment phase of the study. Of the 1004 patients who completed the survey phase, there were 319 eligible patients who advanced and participated in the treatment phase. Of the 319 eligible patients who advanced to the treatment phase 6 did not meet inclusion criteria leaving 313 patients."
428659|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
428660|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
428661|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
428662|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
428663|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
428664|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
428665|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
428666|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
428667|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 8|
428668|NCT00545844|O2|Outcome|Treatment Phase (All Patients) Week 8|
428669|NCT00545844|O1|Outcome|Treatment Phase (All Patients) Week 0|
428670|NCT00545844|E1|Reported Event|All Patients|
428671|NCT00545792|B1|Baseline|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
428672|NCT00545792|P1|Participant Flow|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
428673|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
428674|NCT00545792|O1|Outcome|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
428675|NCT00545792|E1|Reported Event|Avastin|"Avastin and daily radiation~Avastin : Avastin will be administered intravenously (vein) at 10mg/kg every two weeks starting day 1 for a total of 3 doses."
428676|NCT00545779|B1|Baseline|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428677|NCT00545779|P1|Participant Flow|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428678|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428679|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428680|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428681|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428682|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428683|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428684|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428685|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428686|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428687|NCT00545779|O1|Outcome|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428688|NCT00545779|E1|Reported Event|Ibandronate|Participants completed Candidate Identification Questionnaire (CIQ) in Part A and received Ibandronate 150 milligram (mg) tablet orally once-monthly up to 6 months in Part B of the study.
428689|NCT00545766|B1|Baseline|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
428690|NCT00545766|P1|Participant Flow|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
428691|NCT00545766|O1|Outcome|Vinflunine|Vinflunine : Vinflunine 320 mg/m2 will be administered as a 20 minute IV infusion q3w. Patients will be evaluated for toxicity after each cycle of therapy. Response to vinflunine will be assessed every 6 weeks (every 2 cycles) of treatment. A maximum of 6 cycles of therapy are planned.
429111|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428694|NCT00545753|B3|Baseline|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
428695|NCT00545753|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse - 1% - nit comb regimen required
428696|NCT00545753|B1|Baseline|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse - 1% - no nit combing required
428697|NCT00545753|P3|Participant Flow|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
428698|NCT00545753|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
428699|NCT00545753|P1|Participant Flow|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
428700|NCT00545753|O2|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
428701|NCT00545753|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
428702|NCT00545753|O3|Outcome|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC)Instructions for Use
428703|NCT00545753|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit comb regimen required
428704|NCT00545753|O1|Outcome|A - NatrOVA 1% - No Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required
428705|NCT00545753|E2|Reported Event|C - NIX Applied Per Over the Counter (OTC) Instructions|NIX Creme Rinse applied to Over the Counter (OTC) Instructions for Use
428706|NCT00545753|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse - 1% - With or without nit combing
428707|NCT00545740|B5|Baseline|Total|Total of all reporting groups
428708|NCT00545740|B4|Baseline|Placebo|Placebo administered orally once daily
428709|NCT00545740|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
428710|NCT00545740|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
428711|NCT00545740|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
428712|NCT00545740|P4|Participant Flow|Placebo|Placebo administered orally once daily
428713|NCT00545740|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
428714|NCT00545740|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
428715|NCT00545740|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
428716|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428717|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428718|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428719|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428720|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428721|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428722|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428723|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428724|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428725|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428726|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428727|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428728|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428729|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428730|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428731|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428732|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428733|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428734|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428735|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428736|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428737|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428738|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428739|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428740|NCT00545740|O4|Outcome|Placebo|Placebo administered orally once daily
428741|NCT00545740|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428742|NCT00545740|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
428743|NCT00545740|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
428744|NCT00545740|E4|Reported Event|Placebo|Placebo administered orally once daily
428745|NCT00545740|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
428746|NCT00545740|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
428747|NCT00545740|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
428748|NCT00545688|B5|Baseline|Total|Total of all reporting groups
428749|NCT00545688|B4|Baseline|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428841|NCT00545623|P2|Participant Flow|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428842|NCT00545623|P1|Participant Flow|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428750|NCT00545688|B3|Baseline|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428751|NCT00545688|B2|Baseline|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428752|NCT00545688|B1|Baseline|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428753|NCT00545688|P4|Participant Flow|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428754|NCT00545688|P3|Participant Flow|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428755|NCT00545688|P2|Participant Flow|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428756|NCT00545688|P1|Participant Flow|Trastuzumab + Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab intravenous (IV) infusion at a loading dose of 8 milligrams per kilogram (mg/kg) on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 milligrams per square meter (mg/m^2) on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by 5-fluorouracil 600 mg/m^2 IV, epirubicin 90 mg/m^2 IV, and cyclophosphamide 600 mg/m^2 IV (FEC) on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428757|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428758|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428759|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428760|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428761|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428762|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428763|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428764|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428765|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428766|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428767|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428768|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428769|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428843|NCT00545623|O4|Outcome|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428844|NCT00545623|O3|Outcome|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
429857|NCT00542321|B3|Baseline|Total|Total of all reporting groups
428770|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428771|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428772|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a loading dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428773|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428774|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428775|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428776|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428777|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428778|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428779|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428845|NCT00545623|O2|Outcome|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428780|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428781|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428782|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428783|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428784|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428785|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428786|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428787|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428788|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428789|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428846|NCT00545623|O1|Outcome|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
429112|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
428790|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428791|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428792|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428793|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428794|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428795|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428796|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428797|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428798|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428799|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428847|NCT00545623|E4|Reported Event|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428800|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428801|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428802|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428803|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428804|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428805|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428806|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428807|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428808|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428809|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428848|NCT00545623|E3|Reported Event|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428849|NCT00545623|E2|Reported Event|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428810|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428811|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428812|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428813|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428814|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428815|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428816|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428817|NCT00545688|O4|Outcome|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428818|NCT00545688|O3|Outcome|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428819|NCT00545688|O2|Outcome|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428888|NCT00545506|E1|Reported Event|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
428820|NCT00545688|O1|Outcome|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428821|NCT00545688|E4|Reported Event|Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received pertuzumab IV at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 420 mg on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 21."
428822|NCT00545688|E3|Reported Event|Trastuzumab+Pertuzumab|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by docetaxel 75 mg/m^2 IV on Day 1 of Cycle 5 followed by docetaxel 100 mg/m^2 for three cycles (Cycles 6−8) if no dose-limiting toxicity occurred. For Cycles 9 to 11, participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles. Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 12 until Cycle 17."
428823|NCT00545688|E2|Reported Event|Trastuzumab+Pertuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg and pertuzumab IV infusion at a loading dose of 840 mg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg trastuzumab and 420 mg pertuzumab on Day 1 of Cycles 2-4. Docetaxel IV infusion was administered at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428824|NCT00545688|E1|Reported Event|Trastuzumab+Docetaxel|"Neoadjuvant (Pre-Operative) Treatment: Participants received trastuzumab IV infusion at a loading dose of 8 mg/kg on Day 1 of Cycle 1 (21-day cycle) followed by a maintenance dose of 6 mg/kg on Day 1 of Cycles 2-4 and docetaxel IV infusion at a starting dose of 75 mg/m^2 on Day 1 of Cycle 1 followed by 100 mg/m^2 on Day 1 of Cycles 2-4, if no dose limiting toxicity occurred.~Adjuvant (2-Week Post-Operative) Treatment: Participants received trastuzumab 6 mg/kg IV followed by FEC on Day 1 and every 3 weeks thereafter for three cycles (Cycles 5−7). Trastuzumab 6 mg/kg IV was continued every 3 weeks from Cycle 8 to Cycle 17."
428825|NCT00545662|B3|Baseline|Total|Total of all reporting groups
428826|NCT00545662|B2|Baseline|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428827|NCT00545662|B1|Baseline|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428828|NCT00545662|P2|Participant Flow|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428829|NCT00545662|P1|Participant Flow|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428830|NCT00545662|O2|Outcome|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428831|NCT00545662|O1|Outcome|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428832|NCT00545662|E2|Reported Event|Treatment|Treatment with citicoline begun within 24 hours of traumatic brain injury. Treatment was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428833|NCT00545662|E1|Reported Event|Control|The first dose of placebo was administered within 24 hours of traumatic brain injury. Placebo was administered orally or enterally depending upon whether the participant could swallow at 1,000 mg twice a day for 90 days or until the 90-day outcome assessment.
428834|NCT00545623|B5|Baseline|Total|Total of all reporting groups
428835|NCT00545623|B4|Baseline|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428836|NCT00545623|B3|Baseline|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428837|NCT00545623|B2|Baseline|SHAM+RR|"sham acupuncture + relaxation response CD~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428838|NCT00545623|B1|Baseline|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428839|NCT00545623|P4|Participant Flow|SHAM+EDU|"sham acupuncture+education CD~sham acupuncture: sham acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428840|NCT00545623|P3|Participant Flow|ACUP+EDU|"acupuncture+education CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks"
428889|NCT00545441|B3|Baseline|Total|Total of all reporting groups
428850|NCT00545623|E1|Reported Event|ACUP+RR|"acupuncture + relaxation response CD~Acupuncture: acupuncture twice/week for the first 4 weeks and once/week for another 4 weeks~Relaxation Response: listening to CDs with verbal instructions of techniques to elicit relaxation response"
428851|NCT00545584|B4|Baseline|Total|Total of all reporting groups
428852|NCT00545584|B3|Baseline|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
428853|NCT00545584|B2|Baseline|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
428854|NCT00545584|B1|Baseline|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
428855|NCT00545584|P3|Participant Flow|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
428856|NCT00545584|P2|Participant Flow|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
428857|NCT00545584|P1|Participant Flow|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
428858|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
428859|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
428860|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
428861|NCT00545584|O3|Outcome|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
428862|NCT00545584|O2|Outcome|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
428863|NCT00545584|O1|Outcome|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
428864|NCT00545584|E3|Reported Event|Sitagliptin With Diet and Physical Activity Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week."
428865|NCT00545584|E2|Reported Event|Sitagliptin With Diet Advice|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~Intervention on diet which includes advice on diet with a leaflet and a diary"
428866|NCT00545584|E1|Reported Event|Sitagliptin With Standard of Care|"Subjects received sitagliptin 100 mg once daily for 26 Weeks,~and:~No specific intervention (standard recommendation) on physical exercise and diet."
428867|NCT00545571|B1|Baseline|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428868|NCT00545571|P1|Participant Flow|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with erythropoiesis-stimulating agent (ESA) therapy received intravenous methoxy polyethylene glycol-epoetin beta (Mircera), also known as continuous erythropoietin receptor activator (CERA), every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 micrograms (mcg) was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week dose titration period (DTP) to maintain hemoglobin (Hb) concentrations within a country-specific target: 11.0 to 13.0 grams per deciliter (g/dL) in Switzerland and 10.0 to 12.0 g/dL in Austria.
428869|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428870|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428890|NCT00545441|B2|Baseline|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
428891|NCT00545441|B1|Baseline|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
428892|NCT00545441|P2|Participant Flow|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
428871|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428872|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428873|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428874|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428875|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428876|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428877|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428878|NCT00545571|O1|Outcome|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428879|NCT00545571|E1|Reported Event|Mircera in Renal Anemia|Participants with chronic renal anemia who were previously treated with ESA therapy received intravenous Mircera/CERA, every 4 weeks for a total of 52 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg was based upon the dose of ESA received prior to administration of study treatment, while subsequent doses were adjusted during a 16-week DTP to maintain Hb concentrations within a country-specific target: 11.0 to 13.0 g/dL in Switzerland and 10.0 to 12.0 g/dL in Austria.
428880|NCT00545506|B3|Baseline|Total|Total of all reporting groups
428881|NCT00545506|B2|Baseline|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
428882|NCT00545506|B1|Baseline|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
428883|NCT00545506|P2|Participant Flow|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
428884|NCT00545506|P1|Participant Flow|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
428885|NCT00545506|O2|Outcome|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
428886|NCT00545506|O1|Outcome|Heart Surgery, Wound Infection, Conventional Bandage|konventional bandage (conventional gauze covered with elastic adhesive (Medipore™ Dress-it)) on sternal wound
428887|NCT00545506|E2|Reported Event|Heart Surgery, Wound Infection, Warming Bandage, Tissue Oxygen|warming bandage on sternal wound The Warm-Up bandage consists of an adhesive shell and a foam frame that supports a clear window about one cm above the surface of the wound. A battery-powered heating card can then be inserted into the window to provide gentle warming of the wound. The experimental bandage will be continuously applied to the wound and heated to 38°C using a two-hour on/off cycle
428893|NCT00545441|P1|Participant Flow|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
428894|NCT00545441|O2|Outcome|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
428895|NCT00545441|O1|Outcome|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
428896|NCT00545441|E2|Reported Event|Flap|Flap: Advancement flap surgery is performed; no anal fistula plug is placed
428897|NCT00545441|E1|Reported Event|Surgisis® AFP|Surgisis Biodesign Anal Fistula Plug (SurgiSIS AFP): Surgical placement of the Surgisis AFP is performed under general anesthesia.
428898|NCT00545402|B3|Baseline|Total|Total of all reporting groups
428899|NCT00545402|B2|Baseline|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428900|NCT00545402|B1|Baseline|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428901|NCT00545402|P2|Participant Flow|Fixed-Dose MMF + Tacrolimus + Corticosteroid (CS)|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428902|NCT00545402|P1|Participant Flow|Adjusted Mycophenolate Mofetil (MMF)+Tacrolimus+Corticosteroid|Participants received MMF tablets or capsules, 3 grams per day (g/d), orally (PO), twice daily (BID) with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (area under the concentration-time curve [AUC]) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 nanograms per milliliter (ng/mL) from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an intravenous (IV) bolus of methylprednisolone 10-15 milligrams per kilogram (mg/kg) pre-operative on Day 0 per standard practice of the center.
428903|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428904|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428905|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428906|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428907|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428982|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428908|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428909|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428910|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428911|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428912|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428913|NCT00545402|O2|Outcome|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428914|NCT00545402|O1|Outcome|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428915|NCT00545402|E2|Reported Event|Fixed-Dose MMF + Tacrolimus + CS|Participants received MMF capsules or tablets, 2 g/d, PO, BID with meals from Day 0 to Month 12; tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 to Month 1; the dose was reduced to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12; and IV bolus of prednisone, 10-15 mg/kg, pre-operative on Day 0 followed by prednisone tablets, 20 mg/d, PO, from Day 0 through Month 1; 15 mg/d, PO, from the end of Month 1 through Month 2; 10 mg/d, PO, from the end of Month 2 through Month 3; and 5 mg/d from the end of Month 3 through Month 6. Prednisone was discontinued from Month 7 through end of treatment.
428916|NCT00545402|E1|Reported Event|Adjusted MMF + Tacrolimus + CS|Participants received MMF tablets or capsules, 3 g/d, PO, BID with meals from Day 0 to Day 4; thereafter the dose was adjusted based on total exposure (AUC) using the Bayesian method with limited sampling strategy on Days 5 and 14 and Months 1, 3, 6, 9, and 12. Participants also received tacrolimus capsules, adjusted to a target trough level of 8-12 ng/mL from Day 0 through Month 1; the dose was adjusted to reach a target trough level of 3-8 ng/mL from the end of Month 1 through Month 12. Participants also received an IV bolus of methylprednisolone 10-15 mg/kg pre-operative on Day 0 per standard practice of the center.
428917|NCT00545363|B3|Baseline|Total|Total of all reporting groups
428918|NCT00545363|B2|Baseline|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428919|NCT00545363|B1|Baseline|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428920|NCT00545363|P2|Participant Flow|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
429113|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
428921|NCT00545363|P1|Participant Flow|Bone Marker Feedback (BMF) Participants|"Postmenopausal women received ibandronate 150 milligrams (mg) once monthly (QM) orally for 6 months. Participants, in this arm, received bone marker feedback (BMF) at Month 3. BMF was given in terms of providing serum carboxy-terminal collagen crosslinks (CTX) level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by patient relationship program (PRP), carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428922|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428923|NCT00545363|O1|Outcome|BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A “BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428924|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428925|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428926|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428927|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428928|NCT00545363|O2|Outcome|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428929|NCT00545363|O1|Outcome|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428930|NCT00545363|E2|Reported Event|No BMF Participants|Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants were supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake.
428931|NCT00545363|E1|Reported Event|BMF Participants|"Postmenopausal women received ibandronate 150 mg QM orally for 6 months. Participants, in this arm, received BMF at Month 3. BMF was given in terms of providing serum CTX level at Month 3. A BMF-form” was provided to the physicians to allow offering the bone marker result in an easy way. Participants were informed that their results were within or outside of the desired range. In addition, participants were also supported by PRP, carried out by supplying alarm devices, specifically designed to support the participant’s regular drug intake."
428932|NCT00545298|B4|Baseline|Total|Total of all reporting groups
428933|NCT00545298|B3|Baseline|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
428934|NCT00545298|B2|Baseline|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
428935|NCT00545298|B1|Baseline|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
428936|NCT00545298|P3|Participant Flow|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
428937|NCT00545298|P2|Participant Flow|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
428938|NCT00545298|P1|Participant Flow|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
428939|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
428940|NCT00545298|O2|Outcome|B - Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
428941|NCT00545298|O1|Outcome|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
428942|NCT00545298|O3|Outcome|C - Modified Treatment, 5 Wks Lower Dose|200 ppm NO gas 8 hrs / day 1 wk, 20ppm 8 hrs / day 5 weeks. Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
428943|NCT00545298|O2|Outcome|A - Standard of Care (Control)|Standard of Care - dressings and sustained compression only
428944|NCT00545298|O1|Outcome|B - Same Treatment for 6 Weeks|This group received 200ppm NO in Nitrogen delivered constantly to a patch over the wound for 8 hours per day for 6 weeks
428983|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428945|NCT00545298|E3|Reported Event|C - Modified Treatment, 5 Wks Lower Dose|200 ppm No gas 8 hrs/day 1 wk, 20ppm 8hrs/day 5 weeks Gas is NO in nitrogen delivered constantly for 8 hours to a patch over the wound
428946|NCT00545298|E2|Reported Event|B Same Treatment for 6 Weeks|200ppm NO gas 8hrs/day 6 weeks NO gas in nitrogen is delivered constantly to a patch over the wound
428947|NCT00545298|E1|Reported Event|A - Standard of Care (Control)|Standard of care - dressings and sustained compression only
428948|NCT00545272|B7|Baseline|Total|Total of all reporting groups
428949|NCT00545272|B6|Baseline|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428950|NCT00545272|B5|Baseline|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428951|NCT00545272|B4|Baseline|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428952|NCT00545272|B3|Baseline|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428953|NCT00545272|B2|Baseline|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428954|NCT00545272|B1|Baseline|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428955|NCT00545272|P6|Participant Flow|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428956|NCT00545272|P5|Participant Flow|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428957|NCT00545272|P4|Participant Flow|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428958|NCT00545272|P3|Participant Flow|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428959|NCT00545272|P2|Participant Flow|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428960|NCT00545272|P1|Participant Flow|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428961|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428962|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428963|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428964|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428965|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428966|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428967|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428968|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428969|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428970|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428971|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428972|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428973|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428974|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428975|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428976|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428977|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428978|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428979|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428980|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428981|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428984|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428985|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428986|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428987|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428988|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428989|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428990|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428991|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428992|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428993|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428994|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428995|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428996|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428997|NCT00545272|O6|Outcome|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
428998|NCT00545272|O5|Outcome|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
428999|NCT00545272|O4|Outcome|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429000|NCT00545272|O3|Outcome|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429001|NCT00545272|O2|Outcome|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429002|NCT00545272|O1|Outcome|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429003|NCT00545272|E6|Reported Event|Placebo|Placebo to indacaterol (placebo TWISTHALER® device) once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429004|NCT00545272|E5|Reported Event|Formoterol|Formoterol 12 μg delivered by the AEROLIZER® device twice a day and placebo to indacaterol (placebo TWISTHALER® device) once a day for 14 days.
429005|NCT00545272|E4|Reported Event|Indacaterol 500 μg|Indacaterol 500 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429006|NCT00545272|E3|Reported Event|Indacaterol 250 μg|Indacaterol 250 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429007|NCT00545272|E2|Reported Event|Indacaterol 125 μg|Indacaterol 125 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429008|NCT00545272|E1|Reported Event|Indacaterol 62.5 μg|Indacaterol 62.5 μg delivered by the TWISTHALER® device once a day and placebo to formoterol (placebo AEROLIZER® device) twice a day for 14 days.
429009|NCT00545233|B3|Baseline|Total|Total of all reporting groups
429010|NCT00545233|B2|Baseline|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429011|NCT00545233|B1|Baseline|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429012|NCT00545233|P2|Participant Flow|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429013|NCT00545233|P1|Participant Flow|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429104|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429014|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429015|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429016|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429017|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429018|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429019|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429020|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429021|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429022|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429023|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429024|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429025|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429026|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429027|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429105|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429106|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429028|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429029|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429030|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429031|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429032|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429033|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429034|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429035|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429036|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429037|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429038|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429039|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429040|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429041|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429107|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429108|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429042|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of piogliatzone per day orally in the 24 week follow-up period.
429043|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429044|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429045|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429046|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429047|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429048|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429049|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429050|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429051|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429052|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429053|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429054|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429055|NCT00545233|O2|Outcome|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429109|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429110|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429056|NCT00545233|O1|Outcome|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429057|NCT00545233|E2|Reported Event|PEG-INF Alpha-2a + Ribavirin|Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.
429058|NCT00545233|E1|Reported Event|PEG-INF Alpha-2a + Ribavirin+ Pioglitazone|Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received pioglitazone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a)[Pegasys] subcutaneous (sc) once a week plus ribavirin [Copegus] (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.
429059|NCT00545181|B3|Baseline|Total|Total of all reporting groups
429060|NCT00545181|B2|Baseline|Metronidazole Alone|Metronidazole antibiotic therapy alone
429061|NCT00545181|B1|Baseline|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
429062|NCT00545181|P2|Participant Flow|Metronidazole Alone|Metronidazole antibiotic therapy alone
429063|NCT00545181|P1|Participant Flow|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
429064|NCT00545181|O2|Outcome|Metronidazole Alone|Metronidazole antibiotic therapy alone
429065|NCT00545181|O1|Outcome|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
429066|NCT00545181|E2|Reported Event|Metronidazole Alone|Metronidazole antibiotic therapy alone
429067|NCT00545181|E1|Reported Event|Metronidazole + Acidifying Gel (RepHresh)|Receive metronidazole plus vaginal acidifying gel
429068|NCT00545168|B4|Baseline|Total|Total of all reporting groups
429069|NCT00545168|B3|Baseline|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
429070|NCT00545168|B2|Baseline|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
429071|NCT00545168|B1|Baseline|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
429072|NCT00545168|P3|Participant Flow|C - NIX|NIX Creme Rinse (permethrin 1%) applied to Over the Counter (OTC) Instructions for Use
429073|NCT00545168|P2|Participant Flow|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
429074|NCT00545168|P1|Participant Flow|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
429075|NCT00545168|O3|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
429076|NCT00545168|O2|Outcome|B - NatrOVA 1% - Nit Combing Required|NatrOVA Creme Rinse (spinosad) 1% - nit combing regimen required
429077|NCT00545168|O1|Outcome|A - NatrOVA 1% - no Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - no nit combing required Spinosad
429078|NCT00545168|O2|Outcome|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
429079|NCT00545168|O1|Outcome|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
429080|NCT00545168|E2|Reported Event|C - NIX|Nix Creme Rinse (permethrin 1%) applied according to Over the Counter (OTC) Instructions for Use
429081|NCT00545168|E1|Reported Event|A/B - NatrOVA 1% - With/Without Nit Combing|NatrOVA Creme Rinse (spinosad) 1% - With or without nit combing required
429082|NCT00545155|B1|Baseline|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429083|NCT00545155|P1|Participant Flow|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429084|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429085|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429086|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429087|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429088|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429089|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429090|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429091|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429092|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429093|NCT00545155|O1|Outcome|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429094|NCT00545155|E1|Reported Event|Geriatric EMS Patients|Cohort for reliability and concurrent validity testing.
429095|NCT00545103|B5|Baseline|Total|Total of all reporting groups
429096|NCT00545103|B4|Baseline|Placebo|Placebo administered orally once daily
429097|NCT00545103|B3|Baseline|SPD476 (4.8 g)|4.8 g administered orally once daily
429098|NCT00545103|B2|Baseline|SPD476 (2.4 g)|2.4 g administered orally once daily
429099|NCT00545103|B1|Baseline|SPD476 (1.2 g)|1.2 g administered orally once daily
429100|NCT00545103|P4|Participant Flow|Placebo|Placebo administered orally once daily
429101|NCT00545103|P3|Participant Flow|SPD476 (4.8 g)|4.8 g administered orally once daily
429102|NCT00545103|P2|Participant Flow|SPD476 (2.4 g)|2.4 g administered orally once daily
429103|NCT00545103|P1|Participant Flow|SPD476 (1.2 g)|1.2 g administered orally once daily
429114|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429115|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429116|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429117|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429118|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429119|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429120|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429121|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429122|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429123|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429124|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429125|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429126|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429127|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429128|NCT00545103|O4|Outcome|Placebo|Placebo administered orally once daily
429129|NCT00545103|O3|Outcome|SPD476 (4.8 g)|4.8 g administered orally once daily
429130|NCT00545103|O2|Outcome|SPD476 (2.4 g)|2.4 g administered orally once daily
429131|NCT00545103|O1|Outcome|SPD476 (1.2 g)|1.2 g administered orally once daily
429132|NCT00545103|E4|Reported Event|Placebo|Placebo administered orally once daily
429133|NCT00545103|E3|Reported Event|SPD476 (4.8 g)|4.8 g administered orally once daily
429134|NCT00545103|E2|Reported Event|SPD476 (2.4 g)|2.4 g administered orally once daily
429135|NCT00545103|E1|Reported Event|SPD476 (1.2 g)|1.2 g administered orally once daily
429136|NCT00545064|B1|Baseline|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
429137|NCT00545064|P1|Participant Flow|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
429138|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
429139|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
429140|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
429141|NCT00545064|O1|Outcome|Preservative-free COSOPT® at Week 8|
429142|NCT00545064|O2|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 8|
429143|NCT00545064|O1|Outcome|Preservative-free Dorzolamide-timolol (COSOPT®) Week 4|
429144|NCT00545064|E1|Reported Event|Preservative-free Dorzolamide-timolol (COSOPT®)|"subjects received preservative-free dorzolamide-timolol (COSOPT®) administered one drop in the affected eye two times daily~The number of patients analyzed (n=176) differs from the initial tables because 2 patients withdrew consent and for whom no data were available at subsequent visits (only baseline characteristircs were available)."
429145|NCT00545051|B3|Baseline|Total|Total of all reporting groups
429146|NCT00545051|B2|Baseline|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429147|NCT00545051|B1|Baseline|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429148|NCT00545051|P2|Participant Flow|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429149|NCT00545051|P1|Participant Flow|Ibandronate|Participants received 150 milligram (mg) ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 International Units (IU) Vitamin D per day.
429150|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429151|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429152|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429153|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429154|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429155|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429156|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429157|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429158|NCT00545051|O2|Outcome|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429159|NCT00545051|O1|Outcome|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429160|NCT00545051|E2|Reported Event|Placebo|Participants received oral placebo tablet once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429161|NCT00545051|E1|Reported Event|Ibandronate|Participants received 150 mg ibandronate tablet orally once a month for 12 months. Participants also received 1000 mg calcium and 800 IU Vitamin D per day.
429163|NCT00545025|B2|Baseline|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429164|NCT00545025|B1|Baseline|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429165|NCT00545025|P2|Participant Flow|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429166|NCT00545025|P1|Participant Flow|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429167|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429168|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429169|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429170|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429171|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429172|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429173|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429174|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429175|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429176|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429177|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
431052|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
429178|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429179|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429180|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429181|NCT00545025|O2|Outcome|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429182|NCT00545025|O1|Outcome|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03 adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429183|NCT00545025|E2|Reported Event|Fluarix Group|Subjects aged between 18 and 60 years, having previously received one dose of Fluarix™ vaccine during the primary study NCT00374842, received one dose of Fluarix™ vaccine at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from the Fluarix Group in study NCT00374862.
429184|NCT00545025|E1|Reported Event|GSK1247446A Group|Subjects aged between 18 and 60 years, having previously received one dose of the AS03-adjuvanted GSK1247446A vaccine adjuvanted with a full dose of AS03-adjuvant in the primary study NCT00374842, received a single dose of GSK1247446A vaccine adjuvanted with a half dose of AS03- adjuvant at Day 0 of the current follow-up study NCT00545025. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm. Subjects in this group originated from either the GSK1247446A Formulation 1 or GSK1247446A Formulation 2 groups in study NCT00374862.
429185|NCT00544908|B1|Baseline|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
429186|NCT00544908|P1|Participant Flow|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
429187|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
429188|NCT00544908|O1|Outcome|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
429189|NCT00544908|E1|Reported Event|Dasatinib|Dasatinib 70 mg po bid (1 cycle=28 days)
429190|NCT00544882|B3|Baseline|Total|Total of all reporting groups
429191|NCT00544882|B2|Baseline|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429192|NCT00544882|B1|Baseline|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429193|NCT00544882|P3|Participant Flow|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429194|NCT00544882|P2|Participant Flow|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429195|NCT00544882|P1|Participant Flow|Run-In Cycle - All Enrolled|After completing screening, all enrolled participants received the same regimen of 150 μg Desogestrel (DSG) /20 μg Ethinyl Estradiol (EE) combination pills once daily for 21 days followed by placebo once daily for 7 days during Cycle 1.
429196|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
431053|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
429197|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429198|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429199|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429200|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429201|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429202|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429203|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429204|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429205|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429206|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429207|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429208|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429209|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429613|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429210|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429211|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429212|NCT00544882|O2|Outcome|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429213|NCT00544882|O1|Outcome|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429214|NCT00544882|E2|Reported Event|Mircette|After randomization, participants received Mircette consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE tablet once daily for 5 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429215|NCT00544882|E1|Reported Event|DR-1021|After randomization, participants received DR-1021 consisting of 150 μg desogestrel (DSG)/20 μg ethinyl estradiol (EE) administered orally as a combination tablet once daily for 21 days followed by EE 10 μg tablet once daily for 7 days (Cycle 2). Participants who completed Cycle 2 then received Kariva, consisting of 150 μg DSG/20 μg EE administered orally as a combination tablet taken once daily for 21 days followed by placebo tablet once daily for 2 days followed by 10 μg EE taken once daily for 5 days (Cycle 3).
429216|NCT00544869|B4|Baseline|Total|Total of all reporting groups
429217|NCT00544869|B3|Baseline|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
429218|NCT00544869|B2|Baseline|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
429219|NCT00544869|B1|Baseline|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
429220|NCT00544869|P3|Participant Flow|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
429221|NCT00544869|P2|Participant Flow|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
429222|NCT00544869|P1|Participant Flow|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
429223|NCT00544869|O3|Outcome|Dose Escalated to 30 mg/Day|
429224|NCT00544869|O2|Outcome|Continued at 15 mg/Day|
429225|NCT00544869|O1|Outcome|Stopped at End of Treatment Period 1|
429226|NCT00544869|E3|Reported Event|Dose Escalated to 30 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 30 mg/day (treatment period 2)
429227|NCT00544869|E2|Reported Event|Continued at 15 mg/Day|Subsequent 7-day repeated administration of OPC-41061 at 15 mg/day (treatment period 2)
429228|NCT00544869|E1|Reported Event|Stopped at End of Treatment Period 1|Administration of OPC-41061 at 15 mg/day (treatment period 1) for 7 days
429229|NCT00544817|B1|Baseline|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429230|NCT00544817|P1|Participant Flow|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429231|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429232|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429233|NCT00544817|O1|Outcome|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429234|NCT00544817|E1|Reported Event|Combination Therapy|"In the combined modality portion of the study, patients were administered:~Radiation Therapy - 2 Gy/fraction, Single daily fractions M-F, to 60 Gy total Temozolomide - 75 mg/m2 by mouth once daily~Patients took a four week break before beginning follow-up systemic therapy:~Temozolomide - 150 mg /m2 by mouth on days 1-5 every 28 days for 6 cycles Sorafenib - 400 mg by mouth twice a day for 6 months"
429235|NCT00544778|B1|Baseline|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
429236|NCT00544778|P1|Participant Flow|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
429237|NCT00544778|O1|Outcome|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
429238|NCT00544778|E1|Reported Event|Arm 1|High-dose chemotherapy with doxorubicin at 120 mg/m2 and ifosfamide at 2 g/m2 followed by a prolonged schedule of CPT-11 at 20 mg/m2.
429239|NCT00544713|B3|Baseline|Total|Total of all reporting groups
429240|NCT00544713|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429241|NCT00544713|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429242|NCT00544713|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429243|NCT00544713|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429244|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429245|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429246|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429247|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429248|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429249|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429250|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429251|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429252|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429253|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429254|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429255|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429256|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429257|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429258|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429259|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429260|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429261|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429262|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429263|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429264|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429265|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429266|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429267|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429268|NCT00544713|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429269|NCT00544713|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429270|NCT00544713|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|Carboxymethylcellulose based artificial tear
429271|NCT00544713|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|Carboxymethylcellulose and Glycerin based artificial tear
429272|NCT00544674|B1|Baseline|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
429273|NCT00544674|P1|Participant Flow|PR104|Subjects will receive 1100 mg/m^2 PR-104 intravenously once every 21 days (one cycle). In addition, subjects will undergo positron emission topography (PET) imaging with F-18-Fluoro Misonidazole (FMISO) for the assessment of hypoxia and with F-18-Fluorodeoxyglucose (FDG) for the assessment of glucose metabolism.
429274|NCT00544674|O1|Outcome|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
429275|NCT00544674|E1|Reported Event|PR104|1100 mg/m^2 PR104 by IV over one hour every three weeks
429276|NCT00544648|B3|Baseline|Total|Total of all reporting groups
429277|NCT00544648|B2|Baseline|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429278|NCT00544648|B1|Baseline|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429279|NCT00544648|P2|Participant Flow|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429280|NCT00544648|P1|Participant Flow|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429281|NCT00544648|O1|Outcome|Phase I and Phase II|"Phase I-Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-MTD Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.~Phase II-"
429282|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429283|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429284|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429285|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 with concurrent radiotherapy
429286|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429287|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429288|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429289|NCT00544648|O1|Outcome|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429290|NCT00544648|O1|Outcome|Phase I|Nab-paclitaxel in mg/m2 of nab-paclitaxel in combination with carboplatin AUC 2 weekly for 7 weeks with concurrent radiotherapy
429291|NCT00544648|E2|Reported Event|Phase II|MTD of Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429292|NCT00544648|E1|Reported Event|Phase I|Nab-paclitaxel in mg/m2 in combination with carboplatin AUC 2 with concurrent radiotherapy weekly for 7 weeks. Responding patients will be treated with consolidation chemotherapy of nab-paclitaxel 100 mg/m2 weekly for 3 weeks every 21 days followed by carboplatin on day 1 of each cycle. One cycle is 21 days. Patients receive 2 cycles of this consolidation chemotherapy.
429293|NCT00544557|B1|Baseline|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429294|NCT00544557|P1|Participant Flow|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429295|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429296|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429297|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429298|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429299|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429300|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429301|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429302|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429303|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429304|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429305|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429306|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429307|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429308|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429309|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429310|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429311|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429312|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429313|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429314|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429315|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429316|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429317|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429318|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429387|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429614|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429319|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429320|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429321|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429322|NCT00544557|O1|Outcome|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429323|NCT00544557|E1|Reported Event|Etanercept|Participants who had confirmed diagnosis of ankylosing spondylitis (AS) and commenced treatment with etanercept (Enbrel) for the first time as per Summary of Product Characteristics (SmPC) were observed prospectively for 52 weeks. According to SmPC, recommended dose included etanercept 25 milligram (mg) twice weekly or 50 mg once weekly.
429324|NCT00544544|B1|Baseline|Riluzole|Riluzole 100-200 mg/day
429325|NCT00544544|P1|Participant Flow|Riluzole|Riluzole 100-200 mg/day
429326|NCT00544544|O1|Outcome|Riluzole|Riluzole 100-200 mg/day
429327|NCT00544544|E1|Reported Event|Riluzole|Riluzole 100-200 mg/day
429328|NCT00544440|B1|Baseline|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429329|NCT00544440|P1|Participant Flow|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429330|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429331|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429332|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429333|NCT00544440|O1|Outcome|Abiraterone Acetate|Participants were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429334|NCT00544440|E1|Reported Event|Abiraterone Acetate|Patients were treated orally with abiraterone acetate 1000 mg daily and prednisone 5 mg twice a day until clinical disease progression.
429335|NCT00544167|B1|Baseline|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|Doxorubicin 60mg/m2 IV, Cyclophosphamide 600mg/m2 IV every 3 weeks for a total of 12 weeks followed by 12 weeks of paclitaxel (either 175mg/m2 IV every three weeks or 80mg/m2 IV weekly) and sorafenib 400mg twice daily by mouth (up to a maximum of 1 year).
429336|NCT00544167|P1|Participant Flow|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
429337|NCT00544167|O1|Outcome|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|
429338|NCT00544167|E1|Reported Event|Doxorubicin/Cyclophosphamide Then Paclitaxel/Sorafenib|All patients received doxorubicin 60 mg/m2 and cyclophosphamide 600 mg/m2 (AC) both administered intravenously day 1 every 3 weeks for four cycles, followed by paclitaxel 175 mg/m2 intravenously day 1 every 3 weeks for four cycles or 80 mg/m2 for twelve weeks (physician discretion), combined with sorafenib 400 mg orally twice daily. Sorafenib was held during radiation therapy where indicated and resumed once completed. Sorafenib was continued for a total of 12 months and in combination with adjuvant hormonal therapy where indicated.
429339|NCT00543985|B1|Baseline|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' and VO2 max.
429340|NCT00543985|P1|Participant Flow|Stress Echocardiography|Echocardiography was performed prior to and within 60 seconds of completing the standard Bruce treadmill protocol.
429341|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured after exercise
429342|NCT00543985|O1|Outcome|Stress Echocardiography|Echocardiogram E/E' measured before and after exercise
429343|NCT00543985|E1|Reported Event|Stress Echocardiography|Patients completed 3 months of training with 10% weight loss. At the end of that study, they were subjected to pre- and post-stress echocardiography to evaluate E/E' .
429344|NCT00543855|B5|Baseline|Total|Total of all reporting groups
429345|NCT00543855|B4|Baseline|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429346|NCT00543855|B3|Baseline|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429563|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429347|NCT00543855|B2|Baseline|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429348|NCT00543855|B1|Baseline|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429349|NCT00543855|P4|Participant Flow|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429350|NCT00543855|P3|Participant Flow|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks)."
429351|NCT00543855|P2|Participant Flow|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429352|NCT00543855|P1|Participant Flow|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429353|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429354|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429355|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429356|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429357|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429358|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429359|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429360|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429361|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429362|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429363|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429364|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429365|NCT00543855|O4|Outcome|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429366|NCT00543855|O3|Outcome|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429367|NCT00543855|O2|Outcome|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429368|NCT00543855|O1|Outcome|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429369|NCT00543855|E4|Reported Event|Placebo|"Placebo : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429370|NCT00543855|E3|Reported Event|10 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).~Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43- Day 84 (6 weeks)."
429371|NCT00543855|E2|Reported Event|5 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).~Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks)."
429372|NCT00543855|E1|Reported Event|3 mg Donepezil Hydrochloride|"E2020 (Aricept) : Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.~Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast."
429373|NCT00543803|B1|Baseline|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429374|NCT00543803|P1|Participant Flow|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429375|NCT00543803|O2|Outcome|Last Evaluation Assessment on Treatment|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at last evaluation on treatment within 36 months)
429376|NCT00543803|O1|Outcome|Evaluation Assessment at Baseline|Patients treated with Viramune in combination with Truvada (Investigators opinion of patients general health condition at baseline)
429377|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429378|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429379|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429380|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429381|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429382|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429383|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429384|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429385|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429386|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429615|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429388|NCT00543803|O1|Outcome|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg qd for two weeks, then 200 mg bid, Truvada one tablet qd
429389|NCT00543803|E1|Reported Event|Patients Treated With Viramune in Combination With Truvada|Viramune one tablet 200 mg OD for two weeks, then 200 mg BID, Truvada one tablet QD
429390|NCT00543764|B3|Baseline|Total|Total of all reporting groups
429391|NCT00543764|B2|Baseline|Post Pathway|Patients after pathway implementation
429392|NCT00543764|B1|Baseline|Pre Pathway|Patients prior to pathway implementation
429393|NCT00543764|P2|Participant Flow|Post Pathway|Patients after pathway implementation
429394|NCT00543764|P1|Participant Flow|Pre Pathway|Patients prior to pathway implementation
429395|NCT00543764|O2|Outcome|Post Pathway|Patients after pathway implementation
429396|NCT00543764|O1|Outcome|Pre Pathway|Patients prior to pathway implementation
429397|NCT00543764|E2|Reported Event|Post Pathway|Patients after pathway implementation
429398|NCT00543764|E1|Reported Event|Pre Pathway|Patients prior to pathway implementation
429399|NCT00543725|B3|Baseline|Total|Total of all reporting groups
429400|NCT00543725|B2|Baseline|Efavirenz|600 mg once daily
429401|NCT00543725|B1|Baseline|TMC278|25 mg tablet once daily
429402|NCT00543725|P2|Participant Flow|Efavirenz|600 mg once daily
429403|NCT00543725|P1|Participant Flow|TMC278|25 mg tablet once daily
429404|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429405|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429406|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429407|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429408|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429409|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429410|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429411|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429412|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429413|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429414|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429415|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429416|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429417|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429418|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429419|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429420|NCT00543725|O2|Outcome|Efavirenz|600 mg once daily
429421|NCT00543725|O1|Outcome|TMC278|25 mg tablet once daily
429422|NCT00543725|E2|Reported Event|Efavirenz|600 mg once daily
429423|NCT00543725|E1|Reported Event|TMC278|25 mg tablet once daily
429424|NCT00543569|B5|Baseline|Total|Total of all reporting groups
429425|NCT00543569|B4|Baseline|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429426|NCT00543569|B3|Baseline|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429427|NCT00543569|B2|Baseline|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429428|NCT00543569|B1|Baseline|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429429|NCT00543569|P4|Participant Flow|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429430|NCT00543569|P3|Participant Flow|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429431|NCT00543569|P2|Participant Flow|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429432|NCT00543569|P1|Participant Flow|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429433|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429434|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429564|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429435|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429436|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429437|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429438|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429439|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429440|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429441|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429442|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429443|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429444|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429445|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429446|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429447|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429448|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429449|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429450|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429451|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429452|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429453|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429565|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429616|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429454|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429455|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429456|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429457|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429458|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429459|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429460|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429461|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429462|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429463|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429464|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429465|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429466|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429467|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429468|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429469|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429470|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429471|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429472|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429566|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
431054|NCT00540124|O1|Outcome|Placebo|by mouth once a day
429473|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429474|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429475|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429476|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429477|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429478|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429479|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429480|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429481|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429482|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429483|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429484|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429485|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429486|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429487|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429488|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429489|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429490|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429491|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429567|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429492|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429493|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429494|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429495|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429496|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429497|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429498|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429499|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429500|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429501|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429502|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429503|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429504|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429505|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429506|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429507|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429508|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429509|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429510|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429568|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429617|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429511|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429512|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429513|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429514|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429515|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429516|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429517|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429518|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429519|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429520|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429521|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429522|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429523|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429524|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429525|NCT00543569|O4|Outcome|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429526|NCT00543569|O3|Outcome|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429527|NCT00543569|O2|Outcome|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429528|NCT00543569|O1|Outcome|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429529|NCT00543569|E4|Reported Event|Alefacept QOW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 30 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID, and tapered corticosteroids for 6 months.
429569|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429530|NCT00543569|E3|Reported Event|Alefacept QW/Tacrolimus|Participants received alefacept administered as a 7.5 mg IV bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.20 mg/kg/day, and tapered corticosteroids for 6 months.
429531|NCT00543569|E2|Reported Event|Alefacept QW/Tacrolimus/MMF|Participants received alefacept administered as a 7.5 mg intravenous (IV) bolus on Days 0 and 3; 15 mg subcutaneously on Day 7 then weekly (QW) for 12 weeks, then 15 mg subcutaneously monthly until the end of month 6, in addition to tacrolimus at a starting dose of 0.10 mg/kg/day, MMF 750 or 1000 mg BID and tapered corticosteroids for 6 months.
429532|NCT00543569|E1|Reported Event|Tacrolimus/MMF/Basiliximab|Participants received tacrolimus at a starting dose of 0.20 mg/kg/day, mycophenolate mofetil (MMF) 750 or 1000 mg twice daily (BID), basiliximab administered as a 20 mg bolus injection 2 hours prior to transplantation on Day 0 and a 20 mg bolus injection on Day 3 and tapered corticosteroids for 6 months.
429533|NCT00543543|B5|Baseline|Total|Total of all reporting groups
429534|NCT00543543|B4|Baseline|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429535|NCT00543543|B3|Baseline|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429536|NCT00543543|B2|Baseline|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429537|NCT00543543|B1|Baseline|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429538|NCT00543543|P4|Participant Flow|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429539|NCT00543543|P3|Participant Flow|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429540|NCT00543543|P2|Participant Flow|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429541|NCT00543543|P1|Participant Flow|Low-dose V503|V503 (9-Valent Human Papillomavirus [HPV] Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429542|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429543|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429544|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429545|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429546|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429547|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429548|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429549|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429550|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429551|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429552|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429553|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429554|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429555|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429556|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429557|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429558|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429559|NCT00543543|O3|Outcome|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429560|NCT00543543|O2|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429561|NCT00543543|O1|Outcome|Low-dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429562|NCT00543543|O4|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429570|NCT00543543|O2|Outcome|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429571|NCT00543543|O1|Outcome|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429572|NCT00543543|E4|Reported Event|Gardasil|Gardasil (4-Valent HPV Vaccine) 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. Participants will be offered the V503 mid-dose 3-dose regimen in the extension study.
429573|NCT00543543|E3|Reported Event|High-dose V503|V503 (9-Valent HPV Vaccine) high-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429574|NCT00543543|E2|Reported Event|Mid-dose V503|V503 (9-Valent HPV Vaccine) mid-dose 0.5 mL injection in a 3-dose regimen in the base study Part A or Part B. A subset of participants will receive a fourth V503 mid-dose vaccination in the extension study.
429575|NCT00543543|E1|Reported Event|Low-Dose V503|V503 (9-Valent HPV Vaccine) low-dose 0.5 mL injection in a 3-dose regimen in the base study Part A.
429576|NCT00543296|B1|Baseline|0.59 mg Fluocinolone Acetonide Implant|
429577|NCT00543296|P1|Participant Flow|0.59 mg Fluocinolone Acetonide Implant|
429578|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
429579|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
429580|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
429581|NCT00543296|O1|Outcome|0.59 mg Fluocinolone Acetonide Implant|
429582|NCT00543296|E1|Reported Event|0.59 mg Fluocinolone Acetonide Implant|
429583|NCT00543140|B1|Baseline|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429584|NCT00543140|P1|Participant Flow|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429585|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429586|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429587|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429588|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429589|NCT00543140|O1|Outcome|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429590|NCT00543140|E1|Reported Event|REALIZE™ Adjustable Gastric Band|"All subjects have the REALIZE™ Adjustable Gastric Band. Single arm - no comparator.~Swedish Adjustable Gastric Band: Laparoscopic placement of the Swedish Adjustable Gastric Band"
429591|NCT00543101|B3|Baseline|Total|Total of all reporting groups
429592|NCT00543101|B2|Baseline|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429593|NCT00543101|B1|Baseline|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429594|NCT00543101|P2|Participant Flow|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429595|NCT00543101|P1|Participant Flow|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429596|NCT00543101|O2|Outcome|Crossover Week 48|At week 24 the dual PI arm subjects remaining undetectable, crossed over to the DRV/r arm and were followed for an additional 24 weeks.
429597|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429598|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429599|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429600|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429601|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429602|NCT00543101|O2|Outcome|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429603|NCT00543101|O1|Outcome|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429604|NCT00543101|E2|Reported Event|Continue on Current Dual Boosted PI|This is the control group. Subjects in this arm stay on their current regimen - a dual boosted PI combination.
429605|NCT00543101|E1|Reported Event|Switch to DRV/r|Switch to DRV/r at a dose of 600/100 BID for 48 weeks
429606|NCT00542997|B1|Baseline|IgPro20 (All Treated)|All subjects enrolled and treated with subcutaneous infusion of IgPro20
429607|NCT00542997|P1|Participant Flow|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
429608|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
429609|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
429610|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
429611|NCT00542997|O1|Outcome|IgPro20 (PK Substudy)|Subjects enrolled and treated with subcutaneous infusion of IgPro20 participating in the pharmacokinetic sub-study
429612|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20
429618|NCT00542997|O2|Outcome|Pre-study IgG Treatment|Enrolled subjects with at least 3 documented IgG trough values ≥ 5 g/L during up to 6 months of intravenous (IGIV) or subcutaneous (IGSC) replacement therapy prior to receiving IgPro20 study treatment.
429619|NCT00542997|O1|Outcome|IgPro20|Subjects enrolled and treated with subcutaneous infusion of IgPro20 during the Efficacy Period (Infusions 12 to 17)
429620|NCT00542997|E1|Reported Event|IgPro20 (All Treated)|All subjects receiving at least 1 infusion of IgPro20
429621|NCT00542971|B1|Baseline|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
429622|NCT00542971|P1|Participant Flow|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
429623|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
429624|NCT00542971|O1|Outcome|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
429625|NCT00542971|E1|Reported Event|Sorafenib + Idarubicin + Ara-C|Sorafenib starting dose 400 mg orally for 7 days; Idarubicin 12 mg/m2 intravenous (IV) daily (days 1-3); and Ara-C 1.5 g/m2 IV over 24 hours daily (days 1-4)
429626|NCT00542880|B3|Baseline|Total|Total of all reporting groups
429627|NCT00542880|B2|Baseline|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429628|NCT00542880|B1|Baseline|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429629|NCT00542880|P2|Participant Flow|Seretide Diskus First, Then Symbicort Turbuhaler|Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429630|NCT00542880|P1|Participant Flow|Symbicort Turbuhaler First, Then Seretide Diskus|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429631|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429632|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429633|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429634|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429635|NCT00542880|O2|Outcome|Seretide Diskus First|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429636|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429637|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429638|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429639|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429640|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429641|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429642|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429643|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429644|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429645|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429646|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429647|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429648|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429649|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429650|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429651|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429652|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429653|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429654|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429655|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429656|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429657|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429658|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429659|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429660|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429661|NCT00542880|O2|Outcome|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429662|NCT00542880|O1|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429663|NCT00542880|E2|Reported Event|Seretide Diskus|Seretide Diskus (salmeterol/fluticasone) 50/500 μg
429664|NCT00542880|E1|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
429665|NCT00542828|B1|Baseline|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429666|NCT00542828|P1|Participant Flow|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429667|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429668|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429669|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429670|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429671|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429672|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429673|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429674|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429675|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429676|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429677|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429678|NCT00542828|O1|Outcome|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429679|NCT00542828|E1|Reported Event|Thymoglobulin|Thymoglobulin 3.75 mg/kg/day for 5 consecutive days
429680|NCT00542815|B4|Baseline|Total|Total of all reporting groups
429681|NCT00542815|B3|Baseline|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
429682|NCT00542815|B2|Baseline|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
429683|NCT00542815|B1|Baseline|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
429684|NCT00542815|P3|Participant Flow|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
429685|NCT00542815|P2|Participant Flow|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
429686|NCT00542815|P1|Participant Flow|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
429687|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
429688|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
429689|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
429690|NCT00542815|O3|Outcome|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
429691|NCT00542815|O2|Outcome|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
429692|NCT00542815|O1|Outcome|MCI-196 From E07 / E08 Studies|3, 6, 9, 12, or 15g / day as titrated
429693|NCT00542815|E3|Reported Event|Sevelamer From E07 Study|2.4, 4.8, 7.2, 9.6, or 12.0g / day as titrated
429694|NCT00542815|E2|Reported Event|MCI-196 From E07 Study|3, 6, 9, 12, or 15g / day as titrated
429695|NCT00542815|E1|Reported Event|MCI-196 From E07/E08 Studies|3, 6, 9, 12, or 15g / day as titrated
429696|NCT00542789|B3|Baseline|Total|Total of all reporting groups
429697|NCT00542789|B2|Baseline|Comparater: Placebo|Placebo once daily oral
429698|NCT00542789|B1|Baseline|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429699|NCT00542789|P2|Participant Flow|Comparater: Placebo|Placebo once daily oral
429700|NCT00542789|P1|Participant Flow|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429701|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
429702|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429703|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
429704|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429705|NCT00542789|O2|Outcome|Comparater: Placebo|Placebo once daily oral
429706|NCT00542789|O1|Outcome|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429707|NCT00542789|E2|Reported Event|Comparater: Placebo|Placebo once daily oral
429708|NCT00542789|E1|Reported Event|Experimental: Esomeprazole 20 mg|Esomeprazole 20 mg once daily oral
429709|NCT00542620|B3|Baseline|Total|Total of all reporting groups
429710|NCT00542620|B2|Baseline|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429711|NCT00542620|B1|Baseline|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429712|NCT00542620|P2|Participant Flow|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429713|NCT00542620|P1|Participant Flow|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429714|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429715|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429716|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429717|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429718|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429719|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429720|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429721|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429722|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429723|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429724|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429725|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429726|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429727|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429728|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429729|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429730|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429731|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429732|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429733|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429734|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429735|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429736|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429737|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429738|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429739|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429740|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429741|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429742|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429743|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429744|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429745|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429746|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429747|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429748|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429848|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
429849|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
429850|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
429749|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429750|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429751|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429752|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429753|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429754|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429755|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429756|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429757|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429758|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429759|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429760|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429761|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429762|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429763|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429764|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429765|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429766|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429767|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429768|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429769|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429770|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429771|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429772|NCT00542620|O2|Outcome|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429773|NCT00542620|O1|Outcome|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429774|NCT00542620|E2|Reported Event|Separate Injection|Individually adjusted insulin detemir and individually adjusted insulin aspart injected separately s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429775|NCT00542620|E1|Reported Event|Mixed Injection|Individually adjusted insulin detemir extemporaneous mixed with individually adjusted insulin aspart injected s.c. twice daily (in the morning and in the evening) + extra insulin aspart at lunch and breaks, if needed
429776|NCT00542542|B3|Baseline|Total|Total of all reporting groups
429851|NCT00542386|E6|Reported Event|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
429777|NCT00542542|B2|Baseline|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
429778|NCT00542542|B1|Baseline|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
429779|NCT00542542|P2|Participant Flow|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
429780|NCT00542542|P1|Participant Flow|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
429781|NCT00542542|O2|Outcome|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
429782|NCT00542542|O1|Outcome|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
429783|NCT00542542|E2|Reported Event|Group 2: General Anesthesia Alone|"General Anesthesia Alone (Propofol, Midazolam, Fentanyl)~Propofol: 2-2.5 mg/kg IV over 1-4 hours during surgery.~Fentanyl: 50-250 mcg IV over 1-4 hours during surgery.~Midazolam: 0.08 mg/kg IV over 1-4 hours during the surgery."
429784|NCT00542542|E1|Reported Event|Group 1: Paravertebral Block + General Anesthesia|"Paravertebral Block + General Anesthesia (Ropivacaine)~Paravertebral Block: Paravertebral block given as a bolus injection into the paravertebral space.~Ropivacaine: Ropivacaine given by injection into the paravertebral space along the spinal canal."
429785|NCT00542425|B6|Baseline|Total|Total of all reporting groups
429786|NCT00542425|B5|Baseline|Teriparatide|
429787|NCT00542425|B4|Baseline|BA058 80 µg|
429788|NCT00542425|B3|Baseline|BA058 40 µg|
429789|NCT00542425|B2|Baseline|BA058 20 µg|
429790|NCT00542425|B1|Baseline|Placebo|
429791|NCT00542425|P5|Participant Flow|Teriparatide|
429792|NCT00542425|P4|Participant Flow|BA058 80 µg|
429793|NCT00542425|P3|Participant Flow|BA058 40 µg|
429794|NCT00542425|P2|Participant Flow|BA058 20 µg|
429795|NCT00542425|P1|Participant Flow|Placebo|
429796|NCT00542425|O5|Outcome|Teriparatide|
429797|NCT00542425|O4|Outcome|BA058 80 µg|
429798|NCT00542425|O3|Outcome|BA058 40 µg|
429799|NCT00542425|O2|Outcome|BA058 20 µg|
429800|NCT00542425|O1|Outcome|Placebo|
429801|NCT00542425|O5|Outcome|Teriparatide|
429802|NCT00542425|O4|Outcome|BA058 80 µg|
429803|NCT00542425|O3|Outcome|BA058 40 µg|
429804|NCT00542425|O2|Outcome|BA058 20 µg|
429805|NCT00542425|O1|Outcome|Placebo|
429806|NCT00542425|O5|Outcome|Teriparatide|
429807|NCT00542425|O4|Outcome|BA058 80 µg|
429808|NCT00542425|O3|Outcome|BA058 40 µg|
429809|NCT00542425|O2|Outcome|BA058 20 µg|
429810|NCT00542425|O1|Outcome|Placebo|
429811|NCT00542425|O5|Outcome|Teriparatide|
429812|NCT00542425|O4|Outcome|BA058 80 µg|
429813|NCT00542425|O3|Outcome|BA058 40 µg|
429814|NCT00542425|O2|Outcome|BA058 20 µg|
429815|NCT00542425|O1|Outcome|Placebo|
429816|NCT00542425|O5|Outcome|Teriparatide|
429817|NCT00542425|O4|Outcome|BA058 80 µg|
429818|NCT00542425|O3|Outcome|BA058 40 µg|
429819|NCT00542425|O2|Outcome|BA058 20 µg|
429820|NCT00542425|O1|Outcome|Placebo|
429821|NCT00542425|E5|Reported Event|Teriparatide|
429822|NCT00542425|E4|Reported Event|BA058 80 µg|
429823|NCT00542425|E3|Reported Event|BA058 40 µg|
429824|NCT00542425|E2|Reported Event|BA058 20 µg|
429825|NCT00542425|E1|Reported Event|Placebo|
429826|NCT00542386|B7|Baseline|Total|Total of all reporting groups
429827|NCT00542386|B6|Baseline|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
429828|NCT00542386|B5|Baseline|MCI-196: 15 g|MCI-196: 15 g/ day
429829|NCT00542386|B4|Baseline|MCI-196: 12 g|MCI-196: 12 g/ day
429830|NCT00542386|B3|Baseline|MCI-196: 9 g|MCI-196: 9 g/ day
429831|NCT00542386|B2|Baseline|MCI-196: 6 g|MCI-196: 6 g/ day
429832|NCT00542386|B1|Baseline|MCI-196: 3 g|MCI-196: 3 g/ day
429833|NCT00542386|P6|Participant Flow|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
429834|NCT00542386|P5|Participant Flow|MCI-196: 15 g|MCI-196: 15 g/ day
429835|NCT00542386|P4|Participant Flow|MCI-196: 12 g|MCI-196: 12 g/ day
429836|NCT00542386|P3|Participant Flow|MCI-196: 9 g|MCI-196: 9 g/ day
429837|NCT00542386|P2|Participant Flow|MCI-196: 6 g|MCI-196: 6 g/ day
429838|NCT00542386|P1|Participant Flow|MCI-196: 3 g|MCI-196: 3 g/ day
429839|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
429840|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
429841|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
429842|NCT00542386|O3|Outcome|MCI-196: 9 g|MCI-196: 9 g/ day
429843|NCT00542386|O2|Outcome|MCI-196: 6 g|MCI-196: 6 g/ day
429844|NCT00542386|O1|Outcome|MCI-196: 3 g|MCI-196: 3 g/ day
429845|NCT00542386|O6|Outcome|Pooled Placebo|Placebo 9 tablets, 12 tablets and 15 tablets/ day
429846|NCT00542386|O5|Outcome|MCI-196: 15 g|MCI-196: 15 g/ day
429847|NCT00542386|O4|Outcome|MCI-196: 12 g|MCI-196: 12 g/ day
429858|NCT00542321|B2|Baseline|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429859|NCT00542321|B1|Baseline|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429860|NCT00542321|P2|Participant Flow|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429861|NCT00542321|P1|Participant Flow|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429862|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429863|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429864|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429865|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429866|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429867|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429868|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429869|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429870|NCT00542321|O2|Outcome|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429871|NCT00542321|O1|Outcome|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429872|NCT00542321|E2|Reported Event|Manual Turn|Manual Turn: lateral rotation every 2 hours from back to left to back to right to back, with >/= 45 degree lateral rotation angle and 30 degree head of bed elevation for up to 7 consecutive days
429873|NCT00542321|E1|Reported Event|Kinetic Therapy Bed|Kinetic Therapy Bed: Continuous automated turning to 45 degrees with head of the bed elevated 30 degrees or more for up to 7 continuous days
429874|NCT00542308|B1|Baseline|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
429875|NCT00542308|P1|Participant Flow|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
429876|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
429877|NCT00542308|O1|Outcome|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
429878|NCT00542308|E1|Reported Event|Zalutumumab 4-16 mg/kg|Zalutumumab iv infusion once weekly. The dose was titrated until grade 2 rash occurred.
429879|NCT00542269|B4|Baseline|Total|Total of all reporting groups
429880|NCT00542269|B3|Baseline|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429881|NCT00542269|B2|Baseline|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429882|NCT00542269|B1|Baseline|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429883|NCT00542269|P3|Participant Flow|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429929|NCT00542178|O5|Outcome|Fenofibrate + Simvastatin Therapy|Blinded fenofibrate + simvastatin 20-40 mg/d
429930|NCT00542178|O4|Outcome|Standard Blood Pressure Control|Strategy of BP treatment for SBP less than 140 mmHg
429931|NCT00542178|O3|Outcome|Intensive Blood Pressure Control|A strategy of BP treatment for SBP less than 120 mmHg
431055|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
429884|NCT00542269|P2|Participant Flow|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429885|NCT00542269|P1|Participant Flow|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429886|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429887|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429888|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429889|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429890|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429891|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429892|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429893|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429894|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429932|NCT00542178|O2|Outcome|Standard Glycemia Control|Strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
429933|NCT00542178|O1|Outcome|Intensive Glycemia Control|Strategy of intensive glycemia treatment to HbA1c less than 6%
429934|NCT00542178|E6|Reported Event|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
429935|NCT00542178|E5|Reported Event|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
431056|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
429895|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429896|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429897|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429898|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429899|NCT00542269|O3|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429900|NCT00542269|O2|Outcome|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429901|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429902|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429903|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429904|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429905|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429936|NCT00542178|E4|Reported Event|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
429937|NCT00542178|E3|Reported Event|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
429938|NCT00542178|E2|Reported Event|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
429939|NCT00542178|E1|Reported Event|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
429940|NCT00541970|B5|Baseline|Total|Total of all reporting groups
429906|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429907|NCT00542269|O1|Outcome|Aliskiren / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429908|NCT00542269|O2|Outcome|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429909|NCT00542269|O1|Outcome|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429910|NCT00542269|E3|Reported Event|Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg placebo tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg placebo tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429911|NCT00542269|E2|Reported Event|Aliskiren /Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg placebo capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg placebo capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429912|NCT00542269|E1|Reported Event|Aliskiren / Ramipril / Amlodipine|6 weeks treatment with aliskiren 150 mg tablets, ramipril 5 mg capsules, and amlodipine 5-10 mg tablets followed by an additional 6 weeks treatment with aliskiren 300 mg tablets, ramipril 10 mg capsules, and amlodipine 5-10 mg tablets. Patients received amlodipine 5 mg (or 10 mg if they were receiving 10 mg prior to study start). Each dose was to be taken orally with water once daily at approximately 8:00 A.M. with or without food, except on the morning of an office/clinic visit, when the study drug was to be taken at the site after the visit procedures had been completed.
429913|NCT00542178|B7|Baseline|Total|Total of all reporting groups
429914|NCT00542178|B6|Baseline|Fibrate Placebo|Blinded placebo + simvastatin 20-40 mg/d
429915|NCT00542178|B5|Baseline|Fibrate|Blinded fenofibrate + simvastatin 20-40 mg/d
429916|NCT00542178|B4|Baseline|Standard BP Control|A strategy of BP treatment for SBP less than 140 mm Hg
429917|NCT00542178|B3|Baseline|Intensive BP Control|A strategy of BP treatment for SBP less than 120 mm Hg
429918|NCT00542178|B2|Baseline|Standard Glycemia Control|A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%
429919|NCT00542178|B1|Baseline|Intensive Glycemia Control|A strategy of intensive glycemia treatment to HbA1c less than 6%
429920|NCT00542178|P8|Participant Flow|Standard Glycemia Control & Fibrate Placebo|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
429921|NCT00542178|P7|Participant Flow|Intensive Glycemia Control & Fibrate Placebo|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate Placebo: Blinded placebo + simvastatin 20-40 mg/d"
429922|NCT00542178|P6|Participant Flow|Standard Glycemia Control & Fibrate|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
429923|NCT00542178|P5|Participant Flow|Intensive Glycemia Control & Fibrate|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Fibrate: Blinded fenofibrate + simvastatin 20-40 mg/d"
429924|NCT00542178|P4|Participant Flow|Standard Glycemia Control & Standard Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
429925|NCT00542178|P3|Participant Flow|Intensive Glycemia Control & Standard Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Standard Blood Pressure Control: A strategy of BP treatment for SBP less than 140 mm Hg"
429926|NCT00542178|P2|Participant Flow|Standard Glycemia Control & Intensive Blood Pressure Control|"Standard Glycemia Control: A strategy of multiple drugs to treat HbA1c to 7.0% - 7.9%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
429927|NCT00542178|P1|Participant Flow|Intensive Glycemia Control & Intensive Blood Pressure Control|"Intensive Glycemia Control: A strategy of intensive glycemia treatment to HbA1c less than 6%~Intensive Blood Pressure Control: A strategy of BP treatment for SBP less than 120 mm Hg"
429928|NCT00542178|O6|Outcome|Placebo + Simvastatin Therapy|Blinded placebo + simvastatin 20-40 mg/d
429941|NCT00541970|B4|Baseline|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429942|NCT00541970|B3|Baseline|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429943|NCT00541970|B2|Baseline|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429944|NCT00541970|B1|Baseline|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429945|NCT00541970|P4|Participant Flow|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429946|NCT00541970|P3|Participant Flow|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429947|NCT00541970|P2|Participant Flow|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429948|NCT00541970|P1|Participant Flow|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429949|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429950|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429951|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429952|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429953|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429954|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429955|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429956|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429957|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429958|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429959|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429960|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429961|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429962|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429963|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429964|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429965|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430092|NCT00541970|E4|Reported Event|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429966|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429967|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429968|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429969|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429970|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429971|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429972|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429973|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429974|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429975|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429976|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429977|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429978|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429979|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429980|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429981|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429982|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429983|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429984|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429985|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429986|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429987|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429988|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429989|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429990|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430126|NCT00541658|B2|Baseline|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
431057|NCT00540124|O1|Outcome|Placebo|by mouth once a day
429991|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429992|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429993|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429994|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429995|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429996|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429997|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
429998|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
429999|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430000|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430001|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430002|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430003|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430004|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430005|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430006|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430007|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430008|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430009|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430010|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430011|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430012|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430013|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430014|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430015|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430127|NCT00541658|B1|Baseline|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
431058|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
430016|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430017|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430018|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430019|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430020|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430021|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430022|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430023|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430024|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430025|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430026|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430027|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430028|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430029|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430030|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430031|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430032|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430033|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430034|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430035|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430036|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430037|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430038|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430039|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430040|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430041|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430042|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430043|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430044|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430045|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430046|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430047|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430048|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430049|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430050|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430051|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430052|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430053|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430054|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430055|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430056|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430057|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430058|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430059|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430060|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430061|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430062|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430063|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430064|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430065|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430066|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430128|NCT00541658|P3|Participant Flow|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
431059|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
430067|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430068|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430069|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430070|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430071|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430072|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430073|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430074|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430075|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430076|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430077|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430078|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430079|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430080|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430081|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430082|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430083|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430084|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430085|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430086|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430087|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430088|NCT00541970|O4|Outcome|Cervarix 2 Group|Subjects received 3 doses of the Cervarix vaccine, formulation 2, at Month 0, Month 2 and Month 6. The Cervarix vaccine was administered intramuscularly into the deltoid of the non-dominant arm.
430089|NCT00541970|O3|Outcome|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430090|NCT00541970|O2|Outcome|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430091|NCT00541970|O1|Outcome|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430129|NCT00541658|P2|Participant Flow|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430093|NCT00541970|E3|Reported Event|Cervarix 2/Placebo/Cervarix 2 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 2, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430094|NCT00541970|E2|Reported Event|Cervarix 1/Placebo/Cervarix 1 Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 6, and 1 dose of placebo at Month 2. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430095|NCT00541970|E1|Reported Event|Cervarix 1/Placebo Group|Subjects received 2 doses of the Cervarix vaccine, formulation 1, at Month 0 and Month 2, and 1 dose of placebo at Month 6. The Cervarix vaccine and placebo were administered intramuscularly into the deltoid of the non-dominant arm.
430096|NCT00541775|B4|Baseline|Total|Total of all reporting groups
430097|NCT00541775|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430098|NCT00541775|B2|Baseline|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430099|NCT00541775|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430100|NCT00541775|P3|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430101|NCT00541775|P2|Participant Flow|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430102|NCT00541775|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430103|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430104|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430105|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430106|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430107|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430108|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430109|NCT00541775|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430110|NCT00541775|O2|Outcome|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430111|NCT00541775|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430112|NCT00541775|E3|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of placebo matching sitagliptin and placebo matching rosiglitazone q.d. with metformin (≥1500 mg/day).
430113|NCT00541775|E2|Reported Event|Rosiglitazone|The Rosiglitazone group includes data from patients randomized to receive treatment with oral tablets of rosiglitazone 8 mg and placebo matching sitagliptin q.d. in combination with metformin (≥1500 mg/day).
430114|NCT00541775|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg and placebo matching rosiglitazone q.d. (once-daily) with metformin (≥1500 mg/day).
430115|NCT00541671|B3|Baseline|Total|Total of all reporting groups
430116|NCT00541671|B2|Baseline|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
430117|NCT00541671|B1|Baseline|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
430118|NCT00541671|P2|Participant Flow|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
430119|NCT00541671|P1|Participant Flow|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
430120|NCT00541671|O2|Outcome|Promethazine|Patients will be randomized to 6.25mg of promethazine, consisting of 0.25ml of promethazine diluted in 9.75ml of normal saline.
430121|NCT00541671|O1|Outcome|Placebo|Patients will then be randomized to receive placebo, consisting of 10ml of normal saline solution to be administered intravenously with the narcotic
430122|NCT00541671|E2|Reported Event|Promethazine|
430123|NCT00541671|E1|Reported Event|Placebo|
430124|NCT00541658|B4|Baseline|Total|Total of all reporting groups
430125|NCT00541658|B3|Baseline|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
431060|NCT00540124|O1|Outcome|Placebo|by mouth once a day
430130|NCT00541658|P1|Participant Flow|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430131|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430132|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430133|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430134|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430135|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430136|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430137|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430138|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430139|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430140|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430141|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430142|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430143|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430144|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430145|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430146|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430147|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430148|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430149|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430150|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430151|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430152|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430153|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430154|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430155|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430156|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430157|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430158|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430159|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430160|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430161|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430162|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430163|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430164|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430165|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430166|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430167|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430168|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430169|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430170|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430171|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430172|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430173|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430174|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430175|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430176|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430177|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430178|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430179|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430180|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430181|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430182|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430183|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430184|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430185|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430186|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430187|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430188|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430189|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430190|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430191|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430192|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430193|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430194|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430195|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430196|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430197|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430198|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430199|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430200|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430201|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430202|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430203|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430204|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430205|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430206|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430207|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430208|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430209|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430210|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430211|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430212|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430213|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430214|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430215|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430216|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430217|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430218|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430219|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430220|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430221|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430222|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430223|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430224|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430225|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430226|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430227|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430228|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430229|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430230|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430231|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430232|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430233|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430234|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430235|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430236|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430237|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430238|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430239|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430240|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430241|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430242|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430243|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430244|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430245|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430246|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430247|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430248|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430249|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430250|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430251|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430252|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430253|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430254|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430255|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430256|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430257|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430258|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430259|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430260|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430261|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430262|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430263|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430264|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430265|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430266|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430267|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430268|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430269|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430270|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430271|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430272|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430273|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430274|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430275|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430276|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430277|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430278|NCT00541658|O2|Outcome|35 mg DRFB + DRBB|Combined two arms - 35 mg delayed-release following breakfast (DRFB) with 35 mg delayed-relase before breakfast (DRBB)
430279|NCT00541658|O1|Outcome|5 mg IRBB|5 mg immediate-release risedronate tablet daily, at least 30 minutes before breakfast for two years
430280|NCT00541658|O3|Outcome|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430281|NCT00541658|O2|Outcome|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430282|NCT00541658|O1|Outcome|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430283|NCT00541658|E3|Reported Event|35 mg Before Breakfast|35 mg risedronate delayed-release administered at least 30 minutes before breakfast (DRBB), once-a-week
430284|NCT00541658|E2|Reported Event|35 mg After Breakfast|35 mg risedronate delayed-release immediately following breakfast (DRFB), administered once-a-week
430285|NCT00541658|E1|Reported Event|5 mg Before Breakfast|5 mg risedronate immediate-release daily tablet administered at least 30 minutes before breakfast (IRBB)
430286|NCT00541593|B1|Baseline|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
430287|NCT00541593|P1|Participant Flow|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
430288|NCT00541593|O1|Outcome|NOTES Pancreatic Pseudocystgastrostomy Patients|Pancreatic Pseudocystgastrostomy Patients having NOTES procedure
430289|NCT00541593|E1|Reported Event|NOTES Pancreatic Pseudocystgastrostomy Patients|Patients who undergo pancreatic pseudocystgastrostomy via a NOTES technique. All of them are candidates for open or laparoscopic pancreatic pseudocystgastrostomy, but have chosen a less invasive result. Also, all of them have to have imaging criteria which suggest that the stomach and pseudocyst are in close contact, and that the cyst is proximal enough in the stomach to be reachable with an endoscope and/or endoscopic stapler.
430290|NCT00541450|B3|Baseline|Total|Total of all reporting groups
430291|NCT00541450|B2|Baseline|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
430292|NCT00541450|B1|Baseline|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430293|NCT00541450|P2|Participant Flow|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
430317|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430294|NCT00541450|P1|Participant Flow|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430295|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
430296|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
430297|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
430298|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430299|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
430300|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
430301|NCT00541450|O2|Outcome|Pioglitazone (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants in the Pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo. At Week 6, participants were administered 30 mg q.d. pioglitazone.
430302|NCT00541450|O1|Outcome|Sitagliptin (Phase A)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo.
430303|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
430304|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430305|NCT00541450|O2|Outcome|Pioglitazone|"In Phase A (Treatment Day 1 up to Week 12), participants in the pioglitazone group were administered 15 mg once daily (q.d.) of pioglitazone and matching placebo to sitagliptin. At Week 6, all participants were administered 30 mg q.d. pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were administered 45 mg pioglitazone once daily (q.d.)."
430306|NCT00541450|O1|Outcome|Sita/Met FDC|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg once daily (q.d.) of sitagliptin and matching placebo to pioglitazone.~In Phase B (Treatment Week 12 to Week 40), participants that continued were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg twice a day (b.i.d.), which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430307|NCT00541450|E4|Reported Event|Pioglitazone (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, participants were up-titrated to 30 mg q.d.~In Phase B (Treatment Week 12 -Week 40), participants were administered 45 mg q.d."
430308|NCT00541450|E3|Reported Event|Sita/Met FDC (Weeks 0-40)|"In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.~In Phase B (Treatment Week 12-Week 40), participants were switched to the Sita/Met Fixed-Dose Combination (FDC) at a dose of 50/500 mg b.i.d., which was increased to 50/1000 mg b.i.d. over a period of 4 weeks."
430309|NCT00541450|E2|Reported Event|Pioglitazone (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), randomized participants in the pioglitazone group were administered 15 mg q.d. of pioglitazone or matching placebo to sitagliptin. At Week 6, all participants were up-titrated to 30 mg q.d. pioglitazone.
430310|NCT00541450|E1|Reported Event|Sitagliptin (Weeks 0-12)|In Phase A (Treatment Day 1 up to Week 12), participants were administered 100 mg q.d. of sitagliptin or matching placebo to pioglitazone.
430311|NCT00541346|B1|Baseline|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430312|NCT00541346|P1|Participant Flow|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430313|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430314|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430315|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430316|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430318|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430319|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430320|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430321|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430322|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430323|NCT00541346|O1|Outcome|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430324|NCT00541346|E1|Reported Event|Methylphenidate Transdermal System|10mg for one week, with weekly stepwise increases to 15mg, 20mg, and 30mg for additional 7 weeks, if symptom reports remained elevated. Titration decreased one stepwise dosage when significant side-effects were present.
430325|NCT00541307|B1|Baseline|Enrolled Subjects|The total number of enrolled subjects.
430326|NCT00541307|P1|Participant Flow|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430327|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430328|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430329|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430330|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430331|NCT00541307|O1|Outcome|Gore Viabahn Endoprosthesis|All patients enrolled in this single arm study were treated with the Gore Viabahn Endoprosthesis.
430332|NCT00541307|E1|Reported Event|Gore VIABAHN Endoprosthesis With Heparin Bioactive Surface|Gore VIABAHN Endoprosthesis with Heparin Bioactive Surface
430333|NCT00541242|B3|Baseline|Total|Total of all reporting groups
430334|NCT00541242|B2|Baseline|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
430335|NCT00541242|B1|Baseline|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
430336|NCT00541242|P2|Participant Flow|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
430337|NCT00541242|P1|Participant Flow|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
430338|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
430339|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
430340|NCT00541242|O2|Outcome|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
430341|NCT00541242|O1|Outcome|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
430342|NCT00541242|E2|Reported Event|Latanoprost 0.005% Eye Drops|Latanoprost 0.005% eye drops
430343|NCT00541242|E1|Reported Event|Bimatoprost 0.03% Eye Drops|Bimatoprost 0.03% eye drops
430344|NCT00541229|B7|Baseline|Total|Total of all reporting groups
430345|NCT00541229|B6|Baseline|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
430346|NCT00541229|B5|Baseline|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
430347|NCT00541229|B4|Baseline|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
430348|NCT00541229|B3|Baseline|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
430349|NCT00541229|B2|Baseline|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
430350|NCT00541229|B1|Baseline|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
430351|NCT00541229|P6|Participant Flow|200 mg / 100 mg / Placebo|200 mg / 100 mg / Placebo includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
430381|NCT00540969|P2|Participant Flow|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430352|NCT00541229|P5|Participant Flow|100 mg / Placebo / 200 mg|100 mg / Placebo / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
430353|NCT00541229|P4|Participant Flow|Placebo / 200 mg / 100 mg|Placebo / 200 mg / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
430354|NCT00541229|P3|Participant Flow|200 mg / Placebo / 100 mg|200 mg / Placebo / 100 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin 200 mg in Treatment Period I, sitagliptin-matching placebo in Treatment Period II (after Washout Period I), and sitagliptin 100 mg in Treatment Period III (after Washout Period II)
430355|NCT00541229|P2|Participant Flow|100 mg / 200 mg / Placebo|100 mg / 200 mg / Placebo Group includes patients receiving once daily administration of the following treatments: sitagliptin 100 mg in Treatment Period I, sitagliptin 200 mg in Treatment Period II (after Washout Period I), and sitagliptin-matching placebo in Treatment Period III (after Washout Period II)
430356|NCT00541229|P1|Participant Flow|Placebo / 100 mg / 200 mg|Placebo / 100 mg / 200 mg Group includes patients receiving once daily administration of the following treatments: sitagliptin-matching placebo in Treatment Period I, sitagliptin 100 mg in Treatment Period II (after Washout Period I), and sitagliptin 200 mg in Treatment Period III (after Washout Period II)
430357|NCT00541229|O3|Outcome|Placebo|Placebo group included the Treatment Period I data from patients randomized to treatment sequence placebo/Sitagliptin 100 mg/Sitagliptin 200 mg and treatment sequence placebo/Sitagliptin 200 mg/Sitagliptin 100 mg.
430358|NCT00541229|O2|Outcome|Sitagliptin 100mg|Sitagliptin 100 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 100 mg/Sitagliptin 200 mg/placebo and treatment sequence Sitagliptin 100 mg/ placebo/ Sitagliptin 200 mg.
430359|NCT00541229|O1|Outcome|Sitagliptin 200mg|Sitagliptin 200 mg group included the Treatment Period I data from patients randomized to treatment sequence Sitagliptin 200 mg/Sitagliptin 100 mg/placebo and treatment sequence Sitagliptin 200 mg/ placebo/ Sitagliptin 100 mg.
430360|NCT00541229|E3|Reported Event|Placebo|Placebo Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin-matching placebo tablets. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
430361|NCT00541229|E2|Reported Event|Sitagliptin 100 mg|Sitagliptin 100 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 100 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
430362|NCT00541229|E1|Reported Event|Sitagliptin 200 mg|Sitagliptin 200 mg Group included data from all randomized patients in treatment periods with once-daily administration of sitagliptin 200 mg. Due to the crossover design, patients are counted in the denominator for each treatment that they received. Patients are counted in the numerator for the treatment that they were receiving at the time when the AE occurred.
430363|NCT00541190|B3|Baseline|Total|Total of all reporting groups
430364|NCT00541190|B2|Baseline|Healthy Controls|Healthy subjects.
430365|NCT00541190|B1|Baseline|Cystic Fibrosis|Cystic fibrosis patients
430366|NCT00541190|P2|Participant Flow|Healthy Controls|Healthy subjects.
430367|NCT00541190|P1|Participant Flow|Cystic Fibrosis|Cystic fibrosis patients
430368|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects.
430369|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients
430370|NCT00541190|O2|Outcome|Healthy Controls|Healthy subjects without lung disease - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
430371|NCT00541190|O1|Outcome|Cystic Fibrosis|Cystic fibrosis patients - subjects inhaled a nebulized mixture of Indium 111 DTPA and Technetium 99m sulfur colloid.
430372|NCT00541190|E2|Reported Event|Healthy Controls|Healthy subjects.
430373|NCT00541190|E1|Reported Event|Cystic Fibrosis|Cystic fibrosis patients
430374|NCT00541099|B1|Baseline|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
430375|NCT00541099|P1|Participant Flow|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
430376|NCT00541099|O1|Outcome|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
430377|NCT00541099|E1|Reported Event|Avastin & Docetaxel|"Avastin 10.0 mg/kg on days 1 and 15; Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel; Docetaxel 35 mg/m2 on day 1, 8, 15~bevacizumab: Avastin 10.0 mg/kg on days 1 and 15~docetaxel: Dexamethasone 4 mg evening before, morning of and evening of each dose of docetaxel.Docetaxel 35 mg/m2 on day 1, 8, 15"
430378|NCT00540969|B3|Baseline|Total|Total of all reporting groups
430379|NCT00540969|B2|Baseline|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430380|NCT00540969|B1|Baseline|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430382|NCT00540969|P1|Participant Flow|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430383|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430384|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430385|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430386|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430387|NCT00540969|O2|Outcome|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430388|NCT00540969|O1|Outcome|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430389|NCT00540969|E2|Reported Event|Arm II (External-beam Radiotherapy)|"Patients undergo external-beam radiotherapy comprising either a single 8 Gy dose or 20 Gy/5 fractions administered over 1 week.~radiation therapy: Patients undergo radiotherapy for 1 week"
430390|NCT00540969|E1|Reported Event|Arm I (Percutaneous Cryoablation)|"Cryoprobes are inserted percutaneously under CT scan or ultrasound guidance, to the malignant soft tissue-bone interface. Patients undergo ablations using a freeze-thaw-freeze cycle lasting approximately 10-5-10 minutes, respectively.~cryosurgery: Patients undergo cryosurgery using guidance from CT scan or ultrasound"
430391|NCT00540644|B3|Baseline|Total|Total of all reporting groups
430392|NCT00540644|B2|Baseline|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430393|NCT00540644|B1|Baseline|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430394|NCT00540644|P2|Participant Flow|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430395|NCT00540644|P1|Participant Flow|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430396|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430397|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430398|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430399|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430400|NCT00540644|O2|Outcome|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430401|NCT00540644|O1|Outcome|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430402|NCT00540644|E2|Reported Event|Extension - Revlimid, Cyclophosphamide, Prednisone|Extension portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430403|NCT00540644|E1|Reported Event|Original Study - Revlimid, Cyclophosphamide, Prednisone|Original portion of the study where patients received Revlimid® 25 mg p.o. daily on days 1-21 of each 28-day cycle. Cyclophosphamide 50 mg p.o. BID daily on days 1-21 of each 28-day cycle. Prednisone 50 mg p.o. Q.O.D.
430404|NCT00540592|B11|Baseline|Total|Total of all reporting groups
430405|NCT00540592|B10|Baseline|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430406|NCT00540592|B9|Baseline|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430407|NCT00540592|B8|Baseline|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
431061|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
430408|NCT00540592|B7|Baseline|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430409|NCT00540592|B6|Baseline|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430410|NCT00540592|B5|Baseline|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430411|NCT00540592|B4|Baseline|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430412|NCT00540592|B3|Baseline|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430413|NCT00540592|B2|Baseline|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430414|NCT00540592|B1|Baseline|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430415|NCT00540592|P10|Participant Flow|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430416|NCT00540592|P9|Participant Flow|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430417|NCT00540592|P8|Participant Flow|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430418|NCT00540592|P7|Participant Flow|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430419|NCT00540592|P6|Participant Flow|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430420|NCT00540592|P5|Participant Flow|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430421|NCT00540592|P4|Participant Flow|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430422|NCT00540592|P3|Participant Flow|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430423|NCT00540592|P2|Participant Flow|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430424|NCT00540592|P1|Participant Flow|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430425|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430426|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430427|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430428|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430429|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430430|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430431|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430432|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430433|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430434|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430435|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430436|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430437|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430438|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430439|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430440|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430441|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430442|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430443|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430444|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430445|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430446|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
431062|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
430447|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430448|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430449|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430450|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430451|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430452|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430453|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430454|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430455|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430456|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430457|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430458|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430459|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430460|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430461|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430462|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430463|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430464|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430465|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430466|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430467|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430468|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430469|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430470|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430471|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430472|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430473|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430474|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430475|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430476|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430477|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430478|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430479|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430480|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430481|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430482|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430483|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430484|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430485|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
431063|NCT00540124|O1|Outcome|Placebo|by mouth once a day
430486|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430487|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430488|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430489|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430490|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430491|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430492|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430493|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430494|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430495|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430496|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430497|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430498|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430499|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430500|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430501|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430502|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430503|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430504|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430505|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430506|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430507|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430508|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430509|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430510|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430511|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430512|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430513|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430514|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430515|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430516|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430517|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430518|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430519|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430520|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430521|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430522|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430523|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430524|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
431064|NCT00540124|E3|Reported Event|Tamsulosin|0.2 mg by mouth once a day
430525|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430526|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430527|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430528|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430529|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430530|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430531|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430532|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430533|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430534|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430535|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430536|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430537|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430538|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430539|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430540|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430541|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430542|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430543|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430544|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430545|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430546|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430547|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430548|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430549|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430550|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430551|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430552|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430553|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430554|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430555|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430556|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430557|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430558|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430559|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430560|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430561|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430562|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430563|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430762|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430564|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430565|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430566|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430567|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430568|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430569|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430570|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430571|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430572|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430573|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430574|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430575|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430576|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430577|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430578|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430579|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430580|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430581|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430582|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430583|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430584|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430585|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430586|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430587|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430588|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430589|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430590|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430591|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430592|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430593|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430594|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430595|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430596|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430597|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430598|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430599|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430600|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430601|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430602|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430763|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430603|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430604|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430605|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430606|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430607|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430608|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430609|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430610|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430611|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430612|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430613|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430614|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430615|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430616|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430617|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430618|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430619|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430620|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430621|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430622|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430623|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430624|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430625|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430626|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430627|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430628|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430629|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430630|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430631|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430632|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430633|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430634|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430635|NCT00540592|O10|Outcome|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430636|NCT00540592|O9|Outcome|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430637|NCT00540592|O8|Outcome|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430638|NCT00540592|O7|Outcome|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430639|NCT00540592|O6|Outcome|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430640|NCT00540592|O5|Outcome|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430641|NCT00540592|O4|Outcome|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430764|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430642|NCT00540592|O3|Outcome|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430643|NCT00540592|O2|Outcome|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430644|NCT00540592|O1|Outcome|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430645|NCT00540592|E10|Reported Event|Fluarix Young Group|Subjects aged 18-40 years received one dose of Fluarix vaccine.
430646|NCT00540592|E9|Reported Event|Fluarix Elderly Group|Subjects aged ≥65 years received one dose of Fluarix vaccine.
430647|NCT00540592|E8|Reported Event|Influenza Vaccine GSK576389A Formulation 8 Group|Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
430648|NCT00540592|E7|Reported Event|Influenza Vaccine GSK576389A Formulation 7 Group|Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
430649|NCT00540592|E6|Reported Event|Influenza Vaccine GSK576389A Formulation 6 Group|Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
430650|NCT00540592|E5|Reported Event|Influenza Vaccine GSK576389A Formulation 5 Group|Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
430651|NCT00540592|E4|Reported Event|Influenza Vaccine GSK576389A Formulation 4 Group|Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
430652|NCT00540592|E3|Reported Event|Influenza Vaccine GSK576389A Formulation 3 Group|Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
430653|NCT00540592|E2|Reported Event|Influenza Vaccine GSK576389A Formulation 2 Group|Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
430654|NCT00540592|E1|Reported Event|Influenza Vaccine GSK576389A Formulation 1 Group|Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
430655|NCT00540579|B1|Baseline|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
430656|NCT00540579|P1|Participant Flow|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
430657|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
430658|NCT00540579|O1|Outcome|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
430659|NCT00540579|E1|Reported Event|Pomalidomide/Gemcitabine|All patients received gemcitabine 1000 mg/m2 IV on days 1, 8, and 15 of a 28 day cycle. Pomalidomide was administered orally on days 1-21 at doses escalated from 2 mg to 10 mg daily.
430660|NCT00540514|B3|Baseline|Total|Total of all reporting groups
430661|NCT00540514|B2|Baseline|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430662|NCT00540514|B1|Baseline|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430663|NCT00540514|P2|Participant Flow|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel (Taxol®) administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430664|NCT00540514|P1|Participant Flow|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel (ABRAXANE®) 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430665|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430666|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430667|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430683|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430668|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430669|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430670|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430671|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430672|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous (IV) infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430673|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430674|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430675|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430676|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430677|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430678|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430679|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430680|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430681|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430682|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430720|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
431045|NCT00540124|O1|Outcome|Placebo|by mouth once a day
430684|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430685|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430686|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430687|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430688|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430689|NCT00540514|O2|Outcome|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430690|NCT00540514|O1|Outcome|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430691|NCT00540514|E2|Reported Event|Paclitaxel + Carboplatin|Participants received 200 mg/m^2 paclitaxel administered by intravenous infusion followed by carboplatin at AUC = 6 mg*min/mL on Day 1 of a 21-day cycle. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430692|NCT00540514|E1|Reported Event|Albumin-bound Paclitaxel + Carboplatin|Participants received albumin-bound paclitaxel 100 mg/m^2 administered as an intravenous infusion over 30 minutes on Days 1, 8, and 15 of each 21-day cycle. Carboplatin was given at an Area Under the Curve (AUC) = 6 mg*min/mL on Day 1 only of each 21-day cycle, beginning immediately after the completion of albumin-bound paclitaxel administration. Participants could continue treatment at the investigator's discretion until disease progression, development of an unacceptable toxicity, or withdrawal of consent.
430693|NCT00540449|B3|Baseline|Total|Total of all reporting groups
430694|NCT00540449|B2|Baseline|Efavirenz|600 mg once daily for 96 weeks.
430695|NCT00540449|B1|Baseline|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430696|NCT00540449|P2|Participant Flow|Efavirenz|600 mg once daily for 96 weeks.
430697|NCT00540449|P1|Participant Flow|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430698|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430699|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430700|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430701|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430702|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430703|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430704|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430705|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430706|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430707|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430708|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430709|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430710|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430711|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430712|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430713|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430714|NCT00540449|O2|Outcome|Efavirenz|600 mg once daily for 96 weeks.
430715|NCT00540449|O1|Outcome|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430716|NCT00540449|E2|Reported Event|Efavirenz|600 mg once daily for 96 weeks.
430717|NCT00540449|E1|Reported Event|TMC278|25 milligram (mg) tablet once daily for 96 weeks.
430718|NCT00540436|B1|Baseline|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
430719|NCT00540436|P1|Participant Flow|GSK1325760A|First Treatment Period: GSK1325760A 5 mg once a day. Second Treatment Period: GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
430761|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430721|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430722|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430723|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430724|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430725|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430726|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430727|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430728|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430729|NCT00540436|O1|Outcome|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition)
430730|NCT00540436|E1|Reported Event|GSK1325760A|GSK1325760A 5 mg once a day by Week 12. After Week 12, GSK1325760A 10 mg once a day (the dosage could be increased or decreased appropriately according to a participant's condition).
430731|NCT00540423|B3|Baseline|Total|Total of all reporting groups
430732|NCT00540423|B2|Baseline|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430733|NCT00540423|B1|Baseline|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430734|NCT00540423|P3|Participant Flow|SB-497115-GR, Open-label|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count.
430735|NCT00540423|P2|Participant Flow|SB-497115-GR, Double-blind|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7.
430736|NCT00540423|P1|Participant Flow|Placebo|Placebo 12.5 milligrams (mg) for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted to 25 mg or 12.5 mg/day at Week 3 based on the participant's platelet count and then continued up to Week 7
430737|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB497511-GR on the PK sampling day
430738|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
430739|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
430740|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
430741|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB497511-GR on the PK sampling day
430742|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
430743|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497511-GR on the PK sampling day
430744|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
430745|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497511-GR on the PK sampling day
430746|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
430747|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497511-GR on the PK sampling day
430748|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
430749|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
430750|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
430751|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
430752|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
430753|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
430754|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
430755|NCT00540423|O3|Outcome|SB-497115-GR 50 mg|Participants who received 50 mg of SB-497115-GR on the PK sampling day
430756|NCT00540423|O2|Outcome|SB-497115-GR 25 mg|Participants who received 25 mg of SB-497115-GR on the PK sampling day
430757|NCT00540423|O1|Outcome|SB-497115-GR 12.5 mg|Participants who received 12.5 mg of SB-497115-GR on the PK sampling day
430758|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430759|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430760|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
431046|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
430765|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430766|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430767|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430768|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430769|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430770|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430771|NCT00540423|O2|Outcome|SG-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430772|NCT00540423|O1|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430773|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430774|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430775|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430776|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430777|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR during both the double-blind and open-label treatment phases
430778|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430779|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430780|NCT00540423|O2|Outcome|Placebo|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430781|NCT00540423|O1|Outcome|SB-497115-GR|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430782|NCT00540423|E3|Reported Event|SB-497115-GR Long-Term Phase|All participants who received placebo and SB-497115-GR in the double-blind phase and completed the phase continued to receive SB-497115-GR in the open-label phase (19 weeks for SB-497115-GR group and 26 weeks for placebo group; all participants received up to 26 weeks in total). Dose adjustment to 12.5, 25, or 50 mg/day was allowed based on the participant's platelet count
430783|NCT00540423|E2|Reported Event|SB-497115-GR Short-Term (Double-Blind) Phase|SB-497115-GR 12.5 mg for the first 3 weeks of the double-blind phase. The dose of study medication was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430784|NCT00540423|E1|Reported Event|Placebo Short-Term (Double-Blind) Phase|Placebo 12.5 mg for the first 3 weeks of the double-blind phase. The dose of placebo was adjusted at Week 3 based on the participant's platelet count and then continued up to Week 7.
430785|NCT00538642|B3|Baseline|Total|Total of all reporting groups
430786|NCT00538642|B2|Baseline|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430787|NCT00538642|B1|Baseline|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430788|NCT00538642|P2|Participant Flow|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430789|NCT00538642|P1|Participant Flow|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430790|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430791|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430792|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430793|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430794|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430795|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430796|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430797|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430798|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430799|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430800|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430801|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430802|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430803|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430804|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430805|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430806|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430807|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430808|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430809|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430810|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430811|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430812|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430813|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430814|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430815|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430816|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430817|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430818|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430819|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430820|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430821|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430822|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430823|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430824|NCT00538642|O2|Outcome|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430825|NCT00538642|O1|Outcome|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430826|NCT00538642|E2|Reported Event|Ziprasidone Treatment|Subjects switch to ziprasidone from current antipsychotic(s)
430827|NCT00538642|E1|Reported Event|Stay on Current Antipsychotic|Subjects stay on same antipsychotic treatment as at baseline.
430828|NCT00538629|B1|Baseline|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430829|NCT00538629|P1|Participant Flow|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430830|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430831|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430832|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430833|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430834|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430835|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430836|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430837|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430838|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430839|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430840|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430841|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430842|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430843|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430844|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430845|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430846|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430847|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430848|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430849|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430850|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430851|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430852|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430853|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430854|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430855|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430856|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430857|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430858|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
431047|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
430859|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430860|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430861|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430862|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430863|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430864|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430865|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430866|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430867|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430868|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430869|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430870|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430871|NCT00538629|O1|Outcome|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430872|NCT00538629|E1|Reported Event|Ziprasidone|Subjects had to have taken at least 1 dose of ziprasidone 40, 60, or 80 milligrams
430873|NCT00538616|B3|Baseline|Total|Total of all reporting groups
430874|NCT00538616|B2|Baseline|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
430875|NCT00538616|B1|Baseline|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
430876|NCT00538616|P2|Participant Flow|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
430877|NCT00538616|P1|Participant Flow|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
430878|NCT00538616|O2|Outcome|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
430879|NCT00538616|O1|Outcome|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
430880|NCT00538616|E2|Reported Event|Propofol- Precedex|Patients received an infusion of propofol for six hours then a washout period of one hour and then a precedex infusion for six hours.
430881|NCT00538616|E1|Reported Event|Precedex-Propofol|Patients received an infusion of precedex for six hours then a washout period of one hour and then a propofol infusion for six hours.
430882|NCT00538590|B3|Baseline|Total|Total of all reporting groups
430883|NCT00538590|B2|Baseline|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430884|NCT00538590|B1|Baseline|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430885|NCT00538590|P2|Participant Flow|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430886|NCT00538590|P1|Participant Flow|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430887|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430888|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430889|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430890|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430891|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430892|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430893|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430894|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430895|NCT00538590|O2|Outcome|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430896|NCT00538590|O1|Outcome|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430897|NCT00538590|E2|Reported Event|Ologen (Oculusgen)|The collagen matrix will be placed on top of the scleral flap under the conjunctiva after the trabeculectomy.
430898|NCT00538590|E1|Reported Event|MITOMYCIN-C|Application of Mitomycin-C in trabeculectomy to reduce super-scarring.
430899|NCT00540293|B1|Baseline|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
430900|NCT00540293|P1|Participant Flow|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
430901|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430902|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430903|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430904|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430905|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430906|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430907|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430908|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430909|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430910|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430911|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430912|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430913|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430914|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430915|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430916|NCT00540293|O1|Outcome|Total|N=425 (Total: sum of all risk groups)
430917|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430918|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430919|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430920|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430921|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430922|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430923|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430924|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430925|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430926|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430927|NCT00540293|O2|Outcome|Low Risk|N=29(Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430928|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430929|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430930|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430931|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430932|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430933|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430934|NCT00540293|O3|Outcome|Medium Risk|N=45 (Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430935|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430936|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430937|NCT00540293|O4|Outcome|High Risk|N=351 (High Risk: Subjects with CHD, CHD risk equivalent or with 2 or more risk factors conferring a 10 year risk > 20 %, e.g., subjects in Category 4.)
430938|NCT00540293|O3|Outcome|Medium Risk|N=45 ( Medium Risk: Subjects with 2 or more CHD risk factors and 10-year risk for CHD 10-20 %, e.g., subjects in Category 3.)
430939|NCT00540293|O2|Outcome|Low Risk|N=29 (Low Risk: Subjects with 0 or 1 CHD risk factor (who were assumed to have 10-year risk for CHD < 10%) or subjects with 2 or more CHD risk factors and 10-year risk for CHD < 10 %, e.g., subjects in Category 1 or 2.)
430940|NCT00540293|O1|Outcome|Total|N=425 (Total=sum of all risk groups)
430941|NCT00540293|E1|Reported Event|Total Treatment Group (All Subjects Who Received Atorvastatin)|this patient group consists of dyslipidemia patients with various cardiovascular diseases (CVD)risk factors
430942|NCT00540228|B6|Baseline|Total|Total of all reporting groups
430943|NCT00540228|B5|Baseline|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431048|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431049|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
430944|NCT00540228|B4|Baseline|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430945|NCT00540228|B3|Baseline|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430946|NCT00540228|B2|Baseline|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430947|NCT00540228|B1|Baseline|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430948|NCT00540228|P5|Participant Flow|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430949|NCT00540228|P4|Participant Flow|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430950|NCT00540228|P3|Participant Flow|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430951|NCT00540228|P2|Participant Flow|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430952|NCT00540228|P1|Participant Flow|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430953|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430954|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430955|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430956|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430957|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430958|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430959|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430960|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430961|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430962|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430963|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430964|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430965|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430966|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430967|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430968|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430969|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430970|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431050|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431051|NCT00540124|O1|Outcome|Placebo|by mouth once a day
430971|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430972|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430973|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430974|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430975|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430976|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430977|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430978|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430979|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430980|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430981|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430982|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430983|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430984|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430985|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430986|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430987|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430988|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430989|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430990|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430991|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430992|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430993|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430994|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430995|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430996|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430997|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430998|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
430999|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431000|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431001|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431002|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431003|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431004|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431005|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431006|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431007|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431008|NCT00540228|O5|Outcome|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431009|NCT00540228|O4|Outcome|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431010|NCT00540228|O3|Outcome|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431011|NCT00540228|O2|Outcome|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431012|NCT00540228|O1|Outcome|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431013|NCT00540228|E5|Reported Event|Fluarix Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of FluarixTM at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431014|NCT00540228|E4|Reported Event|GSK1247446A 4 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/8 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431015|NCT00540228|E3|Reported Event|GSK1247446A 3 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/4 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431016|NCT00540228|E2|Reported Event|GSK1247446A 2 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with 1/2 dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431017|NCT00540228|E1|Reported Event|GSK1247446A 1 Group|Subjects aged 18-64 years at the time of enrolment received 1 dose of GSK1247446A with a full dose of AS03 adjuvant at Day 0. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
431018|NCT00540124|B4|Baseline|Total|Total of all reporting groups
431019|NCT00540124|B3|Baseline|Tamsulosin|0.2 mg by mouth once a day
431020|NCT00540124|B2|Baseline|Tadalafil|5 mg by mouth once a day
431021|NCT00540124|B1|Baseline|Placebo|by mouth once a day
431022|NCT00540124|P3|Participant Flow|Tamsulosin|0.2 mg by mouth once a day
431023|NCT00540124|P2|Participant Flow|Tadalafil|5 mg by mouth once a day
431024|NCT00540124|P1|Participant Flow|Placebo|by mouth once a day
431025|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431026|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431027|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431028|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431029|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431030|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431031|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431032|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431033|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431034|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431035|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431036|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431037|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431038|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431039|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431040|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431041|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431042|NCT00540124|O1|Outcome|Placebo|by mouth once a day
431043|NCT00540124|O3|Outcome|Tamsulosin|0.2 mg by mouth once a day
431044|NCT00540124|O2|Outcome|Tadalafil|5 mg by mouth once a day
431065|NCT00540124|E2|Reported Event|Tadalafil|5 mg by mouth once a day
431066|NCT00540124|E1|Reported Event|Placebo|by mouth once a day
431067|NCT00540046|B3|Baseline|Total|Total of all reporting groups
431068|NCT00540046|B2|Baseline|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
431069|NCT00540046|B1|Baseline|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
431070|NCT00540046|P2|Participant Flow|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
431071|NCT00540046|P1|Participant Flow|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
431072|NCT00540046|O2|Outcome|B/Delayed|"The delayed group had the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~IUD status was known six months post-abortion."
431073|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm had the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure.~IUD status was known six months post-abortion and insertion."
431074|NCT00540046|O2|Outcome|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
431075|NCT00540046|O1|Outcome|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
431076|NCT00540046|E2|Reported Event|B/Delayed|"The delayed group will have the Copper T 380A IUD inserted at the post-operative visit within 2-4 weeks following the procedure.~Copper T 380A IUD: Copper T 380A IUD will be placed at the 2-4 week post-operative visit."
431077|NCT00540046|E1|Reported Event|A/Immediate|"The patients in the immediate arm will have the Copper T 380A IUD inserted within 15 minutes after delivery of the placenta immediately following procedure~Copper T 380A IUD: Copper T 380A IUD will be placed immediately following the procedure."
431078|NCT00539994|B4|Baseline|Total|Total of all reporting groups
431079|NCT00539994|B3|Baseline|Placebo|Placebo 200 mg BID for 5 days
431080|NCT00539994|B2|Baseline|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431081|NCT00539994|B1|Baseline|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431082|NCT00539994|P3|Participant Flow|Placebo|Placebo 200 mg BID for 5 days
431083|NCT00539994|P2|Participant Flow|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431084|NCT00539994|P1|Participant Flow|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431085|NCT00539994|O4|Outcome|Total|Total of all groups
431086|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
431087|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431088|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431089|NCT00539994|O1|Outcome|MRSA|Methicillin Resistant S. aureus.
431090|NCT00539994|O2|Outcome|Positive Pharyngeal Culture for S. Aureus|Subjects who tested positive for S. aureus in the pharyngeal region.
431091|NCT00539994|O1|Outcome|Positive Nasal Culture for S. Aureus|Screened subjects positive for S. aureus
431092|NCT00539994|O4|Outcome|Total|Total of all Groups
431093|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
431094|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431095|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 Days and Placebo 2 days
431096|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
431097|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431098|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431099|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
431100|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431101|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431102|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431103|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
431104|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431105|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
431106|NCT00539994|O3|Outcome|Placebo|Placebo 200 mg BID for 5 days
431107|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431108|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431109|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431110|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431111|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431112|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
431113|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431114|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
431115|NCT00539994|O2|Outcome|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431116|NCT00539994|O1|Outcome|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and Placebo 2 days
431117|NCT00539994|E3|Reported Event|Placebo|Placebo 200 mg BID for 5 days
431118|NCT00539994|E2|Reported Event|Retapamulin 5 Days|Retapamulin ointment, 1% 200 mg BID 5 days
431119|NCT00539994|E1|Reported Event|Retapamulin 3 Days|Retapamulin ointment, 1% 200 mg BID 3 days and 200 mg Placebo BID for 2 days
431120|NCT00539942|B3|Baseline|Total|Total of all reporting groups
431121|NCT00539942|B2|Baseline|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
431122|NCT00539942|B1|Baseline|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
431123|NCT00539942|P2|Participant Flow|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
431124|NCT00539942|P1|Participant Flow|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
431125|NCT00539942|O2|Outcome|Fondaparinux (Arixtra)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
431126|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
431127|NCT00539942|O2|Outcome|Fondaparinux (Arixtra)|Patients randomized to the Arixtra arm will initiate treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5 mg/day for a total of 21 consecutive days (including hospitalization and after hospital discharge)
431128|NCT00539942|O1|Outcome|Intermittent Compression Devices|Patients will receive intermittent compression devices (ICD's) during the entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
431129|NCT00539942|E2|Reported Event|Fondaparinux (Arixtra)|Patients randomized to treatment arm will initiate ARIXTRA treatment on post-operative day 1 and continue treatment until post-operative day 22 (21 consecutive days). Subjects randomized to this arm are to receive the standard prophylactic dose for major abdominal surgery of 2.5mg/day for a total of 21 consecutive days (this includes both while in the hospital and after hospital discharge)
431130|NCT00539942|E1|Reported Event|Intermittent Compression Devices|Patients will receive standard intermittent compression devices (ICD's) during entire hospitalization after the operative procedure. Patients randomized to the standard of care management will receive ICD's only. This represents the current standard of care at our institution at the time of initiation of the trial.
431131|NCT00539864|B3|Baseline|Total|Total of all reporting groups
431132|NCT00539864|B2|Baseline|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431133|NCT00539864|B1|Baseline|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431134|NCT00539864|P2|Participant Flow|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431135|NCT00539864|P1|Participant Flow|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431136|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431137|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431138|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431139|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431140|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431191|NCT00539617|P1|Participant Flow|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
431141|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431142|NCT00539864|O2|Outcome|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431143|NCT00539864|O1|Outcome|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431144|NCT00539864|E2|Reported Event|TIV (Fluzone)|"Licensed Trivalent Influenza Vaccine (TIV): 2007-2008 formulation containing 15μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~45μg total~(Fluzone, sanofi pasteur)"
431145|NCT00539864|E1|Reported Event|FluBlok|"Recombinant Trivalent Hemagglutinin Influenza Vaccine: 2007-2008 formulation containing 45μg of each hemagglutinin derived from A/Solomon Islands/03/2006 (H1N1), A/Wisconsin/67/2005 (H3N2), and B/Malaysia/2506/2004~135μg total"
431146|NCT00536913|B3|Baseline|Total|Total of all reporting groups
431147|NCT00536913|B2|Baseline|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431148|NCT00536913|B1|Baseline|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431149|NCT00536913|P2|Participant Flow|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431150|NCT00536913|P1|Participant Flow|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431151|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431152|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431153|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431154|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431155|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431156|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431157|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431158|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431159|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431160|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431161|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431162|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431163|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431164|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431165|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431166|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431167|NCT00536913|O2|Outcome|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431168|NCT00536913|O1|Outcome|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431169|NCT00536913|E2|Reported Event|Without Spacer|Budesonide/formoterol pMDI 40/2.25 ug
431170|NCT00536913|E1|Reported Event|With Spacer|Budesonide/formoterol pMDI 40/2.25ug + spacer
431171|NCT00536874|B1|Baseline|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431172|NCT00536874|P1|Participant Flow|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431173|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431174|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431175|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431176|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431192|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
431193|NCT00539617|O1|Outcome|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
431194|NCT00539617|E1|Reported Event|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
431177|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431178|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431179|NCT00536874|O1|Outcome|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431180|NCT00536874|E1|Reported Event|Gemcitabine And Oxaliplatin|"A Phase II Study of Neoadjuvant Gemcitabine And Oxaliplatin In Patients With Potentially Resectable Previously Untreated Pancreatic Adenocarcinoma~gemcitabine hydrochloride: 1,000 mg/m2 IV over 100 minutes on day 1 every 14 days for 4 cycles~oxaliplatin: 80 mg/m2 IV over 2 hours on day 1 every 14 days for 4 cycles.~protein expression analysis~proteomic profiling~diagnostic laboratory biomarker analysis~adjuvant therapy~neoadjuvant therapy~therapeutic conventional surgery"
431181|NCT00539734|B1|Baseline|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
431182|NCT00539734|P1|Participant Flow|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
431183|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
431184|NCT00539734|O1|Outcome|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
431185|NCT00539734|E1|Reported Event|Ranibizumab Group|Ranibizumab 0.5 mg (Lucentis®; Novartis Pharma AG, Basel, Switzerland) was injected intravitreally at 4.0 mm from the limbus in phakic eyes and at 3.5 mm in pseudophakic eyes. Re-treatment with the interval of a month apart is considered under the retinal condition.
431186|NCT00539695|B1|Baseline|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
431187|NCT00539695|P1|Participant Flow|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
431188|NCT00539695|O1|Outcome|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
431189|NCT00539695|E1|Reported Event|IL2 Administration|"SCHEDULE OF IL-2 ADMINISTRATION: Patients will receive a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT.~Time will be measured as 'week beginning with first IL-2 injection.'~T cell Induction via IL-2 to reduce GVHD~IL-2: IL2 Administration:~Patients will be given a fixed dose (1x10e5 units/m2/dose) of IL-2 given as a subcutaneous injection three times weekly (separated by at least one day) for 6 weeks beginning no earlier than day +7 after HSCT but beginning no later than 30 days after HSCT. If the patient has not developed >grade I side effects to IL-2 and has not developed >grade I GVHD then the patient may continue the IL-2 for 6 additional weeks. Time will be measured as ‘week beginning with first IL-2 injection."
431190|NCT00539617|B1|Baseline|FOLFOX and Erlotinib|Single arm study of FOLFOX6 plus Erlotinib
431195|NCT00539591|B4|Baseline|Total|Total of all reporting groups
431196|NCT00539591|B3|Baseline|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
431197|NCT00539591|B2|Baseline|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
431198|NCT00539591|B1|Baseline|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
431199|NCT00539591|P3|Participant Flow|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
431200|NCT00539591|P2|Participant Flow|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
431201|NCT00539591|P1|Participant Flow|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
431202|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431203|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431204|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
431205|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
431206|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
431207|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431208|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431209|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
431210|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
431211|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
431212|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431213|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431214|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
431215|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
431216|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
431217|NCT00539591|O5|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431218|NCT00539591|O4|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431219|NCT00539591|O3|Outcome|Week 24|Psychological assessment completed at Week 24
431220|NCT00539591|O2|Outcome|Week 4|Psychological assessment completed at Week 4
431221|NCT00539591|O1|Outcome|Pretherapy|Psychological assessment completed before start of therapy.
431222|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431223|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431224|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431225|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
431226|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
431227|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
431228|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
431229|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
431230|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431231|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431232|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431233|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
431234|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
431235|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
431236|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
431237|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
431238|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431239|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431240|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431241|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
431242|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
431243|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
431244|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
431245|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
431246|NCT00539591|O8|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431247|NCT00539591|O7|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431248|NCT00539591|O6|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431249|NCT00539591|O5|Outcome|Week 24|QoL assessment completed at Week 24.
431250|NCT00539591|O4|Outcome|Week 12|QoL assessment completed at Week 12.
431251|NCT00539591|O3|Outcome|Week 8|QoL assessment completed at Week 8.
431252|NCT00539591|O2|Outcome|Week 4|QoL assessment completed at Week 4.
431253|NCT00539591|O1|Outcome|Week 2|QoL assessment completed at Week 2.
431254|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431255|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431256|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431257|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
431258|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
431259|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
431260|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
431261|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
431262|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
431263|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431264|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431265|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431266|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
431267|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
431268|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
431269|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
431270|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
431271|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
431272|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431273|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431274|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431275|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
431276|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
431277|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
431278|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
431279|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
431280|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
431281|NCT00539591|O9|Outcome|12 Months After End of Therapy|QoL assessment completed 12 months after end of therapy.
431282|NCT00539591|O8|Outcome|6 Months After End of Therapy|QoL assessment completed 6 months after end of therapy.
431283|NCT00539591|O7|Outcome|End of Therapy|QoL assessment completed at end of therapy.
431284|NCT00539591|O6|Outcome|Week 24|QoL assessment completed at Week 24.
431285|NCT00539591|O5|Outcome|Week 12|QoL assessment completed at Week 12.
431286|NCT00539591|O4|Outcome|Week 8|QoL assessment completed at Week 8.
431287|NCT00539591|O3|Outcome|Week 4|QoL assessment completed at Week 4.
431288|NCT00539591|O2|Outcome|Week 2|QoL assessment completed at Week 2.
431289|NCT00539591|O1|Outcome|Pretherapy|QoL assessment completed before start of therapy.
431290|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
431291|NCT00539591|O1|Outcome|Interferon ɑ-2b|Participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
431292|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
431293|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received interferon ɑ-2b and had pharmacokinetic studies performed are included.
431294|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
431295|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
431296|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
431297|NCT00539591|O2|Outcome|Week 28 - Steady State|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed.
431298|NCT00539591|O1|Outcome|Week 5 - First Dose|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
431299|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-Pegylated Interferon ɑ-2b|Stratum A participants who received pegylated interferon ɑ-2b and had pharmacokinetic studies performed are included.
431300|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
431359|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431301|NCT00539591|O1|Outcome|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
431302|NCT00539591|O2|Outcome|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
431303|NCT00539591|O1|Outcome|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
431304|NCT00539591|O1|Outcome|Stratum B1|"Stratum B: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants, divided into 2 groups based on presence (B1) or absence (B2) of measurable disease~Stratum B1 had presence of measurable disease. Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks.~Interventions: Temozolomide, peginterferon ɑ-2b"
431305|NCT00539591|E3|Reported Event|Temozolomide/Peginterferon ɑ-2b Without Measureable Disease|"Stratum B2: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants without measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks. Stratum B2 (no measurable disease) proceeded with 7 courses as outlined."
431306|NCT00539591|E2|Reported Event|Temozolomide/Peginterferon ɑ-2b With Measureable Disease|"Stratum B1: American Joint Committee on Cancer (AJCC) resected Stage IIIC, unresectable Stage III, Stage IV, and recurrent participants with measurable disease~Participants received 8 weekly doses of peginterferon ɑ-2b 0.5 mcg/kg/dose subcutaneously in combination with temozolomide 75 mg/m^2/dose by mouth daily for 6 weeks followed by 2 week break. The duration of each treatment course was 8 weeks."
431307|NCT00539591|E1|Reported Event|Peginterferon ɑ-2b/Non-pegylated Interferon ɑ-2b|"Stratum A: American Joint Committee on Cancer (AJCC) resected Stages IIC, IIIA, and IIIB~Participants received recombinant interferon ɑ-2b 20 million units/m^2/day intravenously 5 consecutive days per week for 4 weeks followed by peginterferon ɑ-2b 1 mcg/kg subcutaneously once a week for 48 weeks."
431308|NCT00539539|B3|Baseline|Total|Total of all reporting groups
431309|NCT00539539|B2|Baseline|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431310|NCT00539539|B1|Baseline|Feedback On|Automated real-time feedback on CPR Process activated
431311|NCT00539539|P2|Participant Flow|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431312|NCT00539539|P1|Participant Flow|Feedback On|Automated real-time feedback on CPR Process activated
431313|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431314|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431315|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431316|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431317|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431318|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431319|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431320|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431321|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431322|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431323|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431324|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431325|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431326|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431327|NCT00539539|O2|Outcome|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431328|NCT00539539|O1|Outcome|Feedback On|Automated real-time feedback on CPR Process activated
431329|NCT00539539|E2|Reported Event|Feedback Off|For the first three to six months, participating EMS agencies will have defibrillators with automated, real-time feedback inactivated. During this period, the baseline rate of ROSC (and secondary outcomes) will be collected. At the end of this baseline period, EMS agencies will be randomized to one of two interventions, with randomization stratified within site by agency, station, or device. All clusters will cross-over to the opposite feedback strategy at least once during the intervention phase.
431330|NCT00539539|E1|Reported Event|Feedback On|Automated real-time feedback on CPR Process activated
431331|NCT00539526|B4|Baseline|Total|Total of all reporting groups
431332|NCT00539526|B3|Baseline|Latanoprost 0.005%|latanoprost 0.005%
431333|NCT00539526|B2|Baseline|Travoprost 0.004%|travoprost 0.004%
431334|NCT00539526|B1|Baseline|Bimatoprost 0.03%|bimatoprost 0.03%
431335|NCT00539526|P3|Participant Flow|Latanoprost 0.005%|latanoprost 0.005%
431336|NCT00539526|P2|Participant Flow|Travoprost 0.004%|travoprost 0.004%
431337|NCT00539526|P1|Participant Flow|Bimatoprost 0.03%|bimatoprost 0.03%
431338|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
431339|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
431340|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
431341|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
431342|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
431343|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
431344|NCT00539526|O3|Outcome|Latanoprost 0.005%|latanoprost 0.005%
431345|NCT00539526|O2|Outcome|Travoprost 0.004%|travoprost 0.004%
431346|NCT00539526|O1|Outcome|Bimatoprost 0.03%|bimatoprost 0.03%
431347|NCT00539526|E3|Reported Event|Latanoprost 0.005%|latanoprost 0.005%
431348|NCT00539526|E2|Reported Event|Travoprost 0.004%|travoprost 0.004%
431349|NCT00539526|E1|Reported Event|Bimatoprost 0.03%|bimatoprost 0.03%
431350|NCT00539513|B3|Baseline|Total|Total of all reporting groups
431351|NCT00539513|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431352|NCT00539513|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431353|NCT00539513|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431354|NCT00539513|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431355|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431356|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431357|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431358|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431360|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431361|NCT00539513|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431362|NCT00539513|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431363|NCT00539513|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 12 weeks"
431364|NCT00539513|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose titrated to 3000 mg within the first week, in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg by mouth PO (1200 mg AM, 1800 mg PM), 12 weeks"
431365|NCT00539305|B3|Baseline|Total|Total of all reporting groups
431366|NCT00539305|B2|Baseline|Placebo Group|Placebo gel : applied topically daily for six months
431367|NCT00539305|B1|Baseline|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431368|NCT00539305|P2|Participant Flow|Placebo Group|Placebo gel : applied topically daily for six months
431369|NCT00539305|P1|Participant Flow|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431370|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
431371|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431372|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
431373|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431374|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
431375|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431376|NCT00539305|O2|Outcome|Placebo Group|Placebo gel : applied topically daily for six months
431377|NCT00539305|O1|Outcome|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431378|NCT00539305|E2|Reported Event|Placebo Group|Placebo gel : applied topically daily for six months
431379|NCT00539305|E1|Reported Event|Treatment Group|"Dose will be adjusted as needed to maintain a target total T level of 500-900 ng/dl~testosterone gel : 50-100mg applied topically daily for six months"
431380|NCT00539279|B3|Baseline|Total|Total of all reporting groups
431381|NCT00539279|B2|Baseline|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431382|NCT00539279|B1|Baseline|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431383|NCT00539279|P2|Participant Flow|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431384|NCT00539279|P1|Participant Flow|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431385|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431386|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431387|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431388|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431389|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431390|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431391|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
432827|NCT00535587|B3|Baseline|Placebo Pill and Exercise|
431392|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431393|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431394|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431395|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431396|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431397|NCT00539279|O2|Outcome|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431398|NCT00539279|O1|Outcome|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431399|NCT00539279|E2|Reported Event|Relaxation Training (RT)|Relaxation Training (RT): RT aims to teach relaxation methods in an effort to reduce anxiety. RT includes Progressive Muscle Relaxation, Imagery Rehearsal, and breathing training.
431400|NCT00539279|E1|Reported Event|Prolonged Exposure Therapy (PE)|Prolonged Exposure Therapy (PE): PE is a therapy that aims to reduce PTSD symptoms via a systematic exposure to feared memories (by imaginal exposure - repeated narration about the traumatic memory) and situations (by in vivo exposure - engaging in feared but safe activities or facing feared situations).
431401|NCT00539240|B4|Baseline|Total|Total of all reporting groups
431402|NCT00539240|B3|Baseline|AcipHex 20 mg Once, Placebo Once, Nortriptyline|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431403|NCT00539240|B2|Baseline|AcipHex 20 mg Once Daily and BID Placebo|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431404|NCT00539240|B1|Baseline|AciPhex 20 mg BID and Once Daily Placebo|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431405|NCT00539240|P3|Participant Flow|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431406|NCT00539240|P2|Participant Flow|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431407|NCT00539240|P1|Participant Flow|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431408|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431409|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431410|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431411|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431412|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431413|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431414|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431415|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431416|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431417|NCT00539240|O3|Outcome|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431508|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431418|NCT00539240|O2|Outcome|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431419|NCT00539240|O1|Outcome|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431420|NCT00539240|E3|Reported Event|Arm 3|"AcipHex 20 mg once daily, placebo once daily and nortriptyline once daily~Rabeprazole 20mg,placebo dinner ,Low dose Tricyclic Antidepressant: Rabeprazole (Breakfast) study medication, dinner placebo medication, tricyclic antidepressant at bedtime"
431421|NCT00539240|E2|Reported Event|Arm 2|"AcipHex 20 mg once daily and BID placebo~Rabeprazole 20 mg two times, Placebo at bedtime: Breakfast & Dinner study medication - Rabeprazole, placebo for tricyclic antidepressant at bedtime"
431422|NCT00539240|E1|Reported Event|Arm 1|"AciPhex 20 mg BID and once daily placebo~Rabeprazole 20mg, placebo dinner and bedtime: Breakfast study medication - Rabeprazole 20mg, matching placebo at dinner , Placebo for tricyclic antidepressant at bedtime"
431423|NCT00539188|B3|Baseline|Total|Total of all reporting groups
431424|NCT00539188|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431425|NCT00539188|B1|Baseline|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431426|NCT00539188|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431427|NCT00539188|P1|Participant Flow|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431428|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431429|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431430|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431431|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431432|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431433|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431434|NCT00539188|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431435|NCT00539188|O1|Outcome|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431436|NCT00539188|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from N-Acetylcysteine, in addition to the medication regimen they are on at study enrollment.~placebo : placebo, 2 capsules PO AM, 3 capsules PO PM, 6 weeks"
431437|NCT00539188|E1|Reported Event|N-Acetylcysteine|"Patients randomized to this arm will receive N-Acetylcysteine augmentation, at a standard dose (3000 mg daily), in addition to the medication regimen they are on at enrollment~N-Acetylcysteine : 3000 mg PO (1200 mg AM, 1800 mg PM), 6 weeks"
431438|NCT00539110|B3|Baseline|Total|Total of all reporting groups
431439|NCT00539110|B2|Baseline|Ramelteon First, Then Zolpidem|dosed at 2200 and 0200 per the feeding tube
431440|NCT00539110|B1|Baseline|Zolpidem First, Then Ramelteon|dosed at 2200 and 0200 per the feeding tube
431441|NCT00539110|P2|Participant Flow|Ramelteon, Then Zolpidem|"medication dosed at 2200 and 0200 per the feeding tube~washout with no sleep meds (x3 nights); ramelteon (x4 nights); washout (x3 nights); then zolpidem (x 4 nights)"
431442|NCT00539110|P1|Participant Flow|Zolpidem First, Then Ramelteon|"medication dosed at 2200 and 0200 per feeding tube~washout with no sleep meds (3 nights); zolpidem (x4 nights); washout (x3 nights); then ramelteon (x4 nights)"
431443|NCT00539110|O2|Outcome|Ramelteon|dosed at 2200 and 0200 per the feeding tube
431444|NCT00539110|O1|Outcome|Zolpidem|medication dosed at 2200 and 0200 per feeding tube
431445|NCT00539110|E2|Reported Event|Ramelteon|"dosed at 2200 and 0200 per the feeding tube~ramelteon: medication dosed at 2200 and 0200 per feeding tube"
431446|NCT00539110|E1|Reported Event|Zolpidem|"medication dosed at 2200 and 0200 per feeding tube~zolipidem: dosed at 2200 and 0200 per feeding tube"
431447|NCT00539032|B3|Baseline|Total|Total of all reporting groups
431448|NCT00539032|B2|Baseline|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431449|NCT00539032|B1|Baseline|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431450|NCT00539032|P2|Participant Flow|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431451|NCT00539032|P1|Participant Flow|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431452|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431453|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431454|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431455|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431456|NCT00539032|O2|Outcome|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431457|NCT00539032|O1|Outcome|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431458|NCT00539032|E2|Reported Event|Group 2: Menactra® Primary Vaccine (Control) Group|Participants who had not previously been given any meningococcal vaccine (meningococcal vaccine naive) received a primary vaccination with Menactra® vaccine.
431459|NCT00539032|E1|Reported Event|Group 1: Menactra® Booster Group|Participants who had received 2 doses of quadrivalent (A, C, Y, and W-135) meningococcal polysaccharide vaccine before age 2 years received a booster vaccination with Menactra® vaccine.
431460|NCT00539006|B5|Baseline|Total|Total of all reporting groups
431461|NCT00539006|B4|Baseline|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
431462|NCT00539006|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431463|NCT00539006|B2|Baseline|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
431464|NCT00539006|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431465|NCT00539006|P4|Participant Flow|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
431466|NCT00539006|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431467|NCT00539006|P2|Participant Flow|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
431468|NCT00539006|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431469|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
431470|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431471|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
431472|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431473|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
431474|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431475|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
431476|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431477|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
432828|NCT00535587|B2|Baseline|Mestinon and Attention Control|
431478|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431479|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431480|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
431481|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431482|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS)110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431483|NCT00539006|O4|Outcome|Placebo - FP/FF|Participants who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
431484|NCT00539006|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431485|NCT00539006|O2|Outcome|Placebo - FF/FP|Participants who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
431486|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray (FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431487|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
431488|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431489|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431490|NCT00539006|O3|Outcome|Total|All participants on both arms preference.
431491|NCT00539006|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Participants who received Fluticasone Propionate Nasal Spray (FPNS) 110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week (treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
431492|NCT00539006|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Participants who received Fluticasone Furoate Nasal Spray(FFNS) 110 mcg every day (QD) followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
431493|NCT00539006|E4|Reported Event|Placebo - FP|Subjects who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
431494|NCT00539006|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
431495|NCT00539006|E2|Reported Event|Fluticason Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
431496|NCT00539006|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
431497|NCT00538915|B1|Baseline|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
431498|NCT00538915|P1|Participant Flow|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
431499|NCT00538915|O1|Outcome|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg administered intravenously every 3 or 4 weeks for approximately 1 year.
431500|NCT00538915|E1|Reported Event|Nabi-IGIV 10% Administered On A 3-Week or 4-Week Interval|Each subject received a total Nabi-IGIV 10% [Immune Globulin Intravenous (Human), 10%] infusion of 300-800 mg/kg per month administered intravenously every 3 or 4 weeks for approximately 1 year.
431501|NCT00538902|B4|Baseline|Total|Total of all reporting groups
431502|NCT00538902|B3|Baseline|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431503|NCT00538902|B2|Baseline|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431504|NCT00538902|B1|Baseline|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431505|NCT00538902|P3|Participant Flow|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
431506|NCT00538902|P2|Participant Flow|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 24 weeks.
431507|NCT00538902|P1|Participant Flow|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 12 weeks.
431509|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431510|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431511|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431512|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431513|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431514|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431515|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431516|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431517|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431518|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431519|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431520|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431521|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431522|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431523|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431524|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431525|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431526|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431527|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431528|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431529|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431530|NCT00538902|O1|Outcome|All Open-Label Adalimumab|All treatment groups participating in the Double-Blind period of the study.
431531|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431532|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431533|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431534|NCT00538902|O3|Outcome|Adalimumab 80 mg|Adalimumab 80 mg administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431535|NCT00538902|O2|Outcome|Adalimumab 40 mg|Adalimumab 40 mg administered subcutaneously (SC) every other week (eow) for 104 weeks.
431536|NCT00538902|O1|Outcome|Placebo|Placebo administered subcutaneously (SC) every other week (eow) for 12 weeks, followed by adalimumab 40 mg SC eow for 92 weeks.
431537|NCT00538902|E4|Reported Event|Any Adalimumab|Any adalimumab exposure during the entire study, whether from Double-Blind or Open-Label treatment.
431538|NCT00538902|E3|Reported Event|DB Phase - Adalimumab 80 mg EOW|Adalimumab 80 mg administered subcutaneously every other week during Double-Blind treatment.
431539|NCT00538902|E2|Reported Event|DB Phase - Adalimumab 40 mg EOW|Adalimumab 40 mg administered subcutaneously every other week during Double-Blind treatment.
431540|NCT00538902|E1|Reported Event|DB Phase - Placebo EOW|Placebo administered subcutaneously every other week during Double-Blind treatment.
431541|NCT00538863|B1|Baseline|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
431542|NCT00538863|P1|Participant Flow|Fentanyl Sublingual Spray|In the titration period, patients were titrated upward to a maximum dose of 1600 µg fentanyl sublingual spray. In the maintenance period, patients received a dose of 100 to 1600 µg fentanyl sublingual spray determined in a previous study (INS-05-001, NCT00538850) or in the titration period of the current study.
431543|NCT00538863|O2|Outcome|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
431544|NCT00538863|O1|Outcome|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
431617|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431618|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431619|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431545|NCT00538863|E2|Reported Event|Fentanyl Sublingual Spray Maintenance|Patients received fentanyl sublingual spray up to a maximum of 4 times per day with a minimum separation of 4 hours between treatments for 90 days. Patients received a dose of 100 to 1600 µg determined in a previous study (INS-05-001, NCT00538850) or in the open-label dose titration period of the current study. The dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects.
431546|NCT00538863|E1|Reported Event|Fentanyl Sublingual Spray Titration|Patients received fentanyl sublingual spray to treat up to a maximum of 4 breakthrough pain episodes per day with a minimum separation of 4 hours between treatments. Patients started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 26 days was reached.
431547|NCT00538850|B1|Baseline|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431548|NCT00538850|P3|Participant Flow|Placebo - Double-blind|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431549|NCT00538850|P2|Participant Flow|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431550|NCT00538850|P1|Participant Flow|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
431551|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431552|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431553|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431554|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431555|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431556|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431557|NCT00538850|O2|Outcome|Placebo|Participants received placebo 3 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431558|NCT00538850|O1|Outcome|Fentanyl Sublingual Spray|Participants received fentanyl sublingual spray 7 times randomly (out of 10 treatments total) to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431559|NCT00538850|E2|Reported Event|Fentanyl Sublingual Spray - Double-blind|Participants received fentanyl sublingual spray 7 times or placebo 3 times in random order to treat up to a maximum of 2 breakthrough pain episodes per day with a minimum separation of 2 hours between treatments. Patients received a dose of 100 to 1600 µg determined in the open-label dose titration period of the current study.
431560|NCT00538850|E1|Reported Event|Fentanyl Sublingual Spray - Titration|In the open-label titration period of the study, participants started at a dose of 100, 200, or 400 µg and titrated upward to a maximum dose of 1600 µg. Titration was stopped when the dose administered provided adequate analgesia for breakthrough pain without unacceptable side effects or the maximum titration period of 21±5 days was reached.
431561|NCT00538785|B3|Baseline|Total|Total of all reporting groups
431562|NCT00538785|B2|Baseline|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431563|NCT00538785|B1|Baseline|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
432829|NCT00535587|B1|Baseline|Mestinon & Exercise|
431564|NCT00538785|P2|Participant Flow|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431565|NCT00538785|P1|Participant Flow|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431566|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431567|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431568|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431569|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431570|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431571|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431572|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431573|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431574|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431575|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431576|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431577|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431578|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431620|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431621|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431693|NCT00536731|B3|Baseline|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431579|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431580|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431581|NCT00538785|O2|Outcome|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431582|NCT00538785|O1|Outcome|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431583|NCT00538785|E2|Reported Event|Palivizumab|Palivizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431584|NCT00538785|E1|Reported Event|Motavizumab (MEDI-524)|Motavizumab was administered as an intramuscular injection at 15 mg/kg every 30 days during the RSV season for a total of 5 scheduled injections. Additionally, children who underwent cardiac surgery with cardiopulmonary bypass through Study Day 150 were to receive a protocol-specified replacement dose of study drug immediately following the surgery when determined by the physician to be medically stable for an IM injection.
431585|NCT00538512|B4|Baseline|Total|Total of all reporting groups
431586|NCT00538512|B3|Baseline|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
431587|NCT00538512|B2|Baseline|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
431588|NCT00538512|B1|Baseline|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
431589|NCT00538512|P3|Participant Flow|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
431590|NCT00538512|P2|Participant Flow|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
431591|NCT00538512|P1|Participant Flow|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
431592|NCT00538512|O3|Outcome|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
431593|NCT00538512|O2|Outcome|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
431594|NCT00538512|O1|Outcome|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
431595|NCT00538512|E3|Reported Event|Placebo|Physiologic saline administered as a nasal spray or intramuscular injection
431596|NCT00538512|E2|Reported Event|Flumist - Live-attenuated Influenza Vaccine|live-attenuated influenza vaccine Flumist, manufactured by MedImmune
431597|NCT00538512|E1|Reported Event|Fluzone - Trivalent Inactivated Influenza Vaccine|the trivalent inactivated influenza vaccine - Fluzone, manufactured by Sanofi-Pasteur
431598|NCT00538473|B3|Baseline|Total|Total of all reporting groups
431599|NCT00538473|B2|Baseline|Fluarix Group|Subjects received 1 dose of Fluarix™.
431600|NCT00538473|B1|Baseline|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431601|NCT00538473|P2|Participant Flow|Fluarix Group|Subjects received 1 dose of Fluarix™.
431602|NCT00538473|P1|Participant Flow|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431603|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431604|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431605|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431606|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431607|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431608|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431609|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431610|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431611|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431612|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431613|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431614|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431615|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431616|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431622|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431623|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431624|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431625|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431626|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431627|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431628|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431629|NCT00538473|O2|Outcome|Fluarix Group|Subjects received 1 dose of Fluarix™.
431630|NCT00538473|O1|Outcome|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431631|NCT00538473|E2|Reported Event|Fluarix Group|Subjects received 1 dose of Fluarix™.
431632|NCT00538473|E1|Reported Event|FluAS25 (GSK576389A) Group|Subjects received 1 dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A).
431633|NCT00538434|B5|Baseline|Total|Total of all reporting groups
431634|NCT00538434|B4|Baseline|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431635|NCT00538434|B3|Baseline|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431636|NCT00538434|B2|Baseline|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431637|NCT00538434|B1|Baseline|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431638|NCT00538434|P4|Participant Flow|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431639|NCT00538434|P3|Participant Flow|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431640|NCT00538434|P2|Participant Flow|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431641|NCT00538434|P1|Participant Flow|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431642|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431643|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431644|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431645|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431646|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431647|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431648|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431649|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431650|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431651|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431652|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431653|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431654|NCT00538434|O4|Outcome|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431655|NCT00538434|O3|Outcome|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431656|NCT00538434|O2|Outcome|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431657|NCT00538434|O1|Outcome|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431658|NCT00538434|E4|Reported Event|Placebo|saline placebo IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431659|NCT00538434|E3|Reported Event|Reslizumab 3 mg/kg|reslizumab 3 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431660|NCT00538434|E2|Reported Event|Reslizumab 2 mg/kg|reslizumab 2 mg/kg IV on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431661|NCT00538434|E1|Reported Event|Reslizumab 1 mg/kg|reslizumab 1 mg/kg intravenous (IV) on Day 0 of each 28-day (+/-7 days) cycle, for up to 4 cycles
431662|NCT00536809|B1|Baseline|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle
431663|NCT00536809|P1|Participant Flow|Lapatinib/Oxaliplatin/Capecitabine|Phase I: Dose escalation to a maximum tolerated dose of lapatinib 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle. Phase II: Lapatinib 1000 mg/day administered orally on Days 1-21, oxaliplatin 130 mg/m^2 administered intravenously on Day 1, and capecitabine 1500 mg/m^2/day on Days 1-14 of a 21-day cycle.
431664|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431665|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431666|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431667|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431668|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431669|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431670|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431671|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431672|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431673|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431674|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431675|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431676|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431677|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431678|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431679|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431680|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431681|NCT00536809|O1|Outcome|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431682|NCT00536809|E1|Reported Event|Lap. 1000 mg/Oxaliplatin 130 mg/m^2/Capecitabine 1500 mg/m^2|Lapatinib (Lap.) 1000 milligrams (mg)/day administered orally on Days 1-21, oxaliplatin 130 mg/square meters (m^2) administered intravenously on Day 1, and capecitabine 1500 mg/m^2 administered orally twice a day on Days 1-14 of a 21-day cycle
431683|NCT00536744|B3|Baseline|Total|Total of all reporting groups
431684|NCT00536744|B2|Baseline|Non-energized (Inactive) Application + Standard of Care|Sham: Sham treatment (non-energized, inactive device) + Standard of care wound dressing.
431685|NCT00536744|B1|Baseline|dermaPACE Application + Standard of Care|dermaPACE: dermaPACE + Standard of care wound dressing.
431686|NCT00536744|P2|Participant Flow|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
431687|NCT00536744|P1|Participant Flow|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
431688|NCT00536744|O2|Outcome|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
431689|NCT00536744|O1|Outcome|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
431690|NCT00536744|E2|Reported Event|Non-energized (Inactive) Application + Standard of Care|"Non-energized (inactive) application + standard of care~Sham: Sham treatment + Standard of care wound dressing."
431691|NCT00536744|E1|Reported Event|dermaPACE Application + Standard of Care|"dermaPACE application + standard of care~dermaPACE: dermaPACE + Standard of care wound dressing."
431692|NCT00536731|B4|Baseline|Total|Total of all reporting groups
432830|NCT00535587|P4|Participant Flow|Placebo Pill and Attention Control|
431694|NCT00536731|B2|Baseline|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431695|NCT00536731|B1|Baseline|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431696|NCT00536731|P3|Participant Flow|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431697|NCT00536731|P2|Participant Flow|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431698|NCT00536731|P1|Participant Flow|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431699|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431700|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431701|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431702|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431703|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431704|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431705|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431706|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431707|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431708|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431709|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431710|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431711|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431712|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431713|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431714|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431715|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431716|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431717|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431718|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431719|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431720|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431721|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431722|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431723|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431724|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431725|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431726|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431727|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431728|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431729|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431730|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431731|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431732|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431733|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431734|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431735|NCT00536731|O3|Outcome|Pulmicort Turbuhaler|Pulmicort®Turbuhaler® 100 μg 1 Inhalation Twice Daily
431736|NCT00536731|O2|Outcome|Symbicort Turbuhaler|Symbicort Turbuhaler® 80/4.5 μg 1 Inhalation Twice Daily
431737|NCT00536731|O1|Outcome|Symbicort pMDI|Symbicort®pMDI® 40/2.25 μg 2 Actuations Twice Daily
431738|NCT00536731|E3|Reported Event|Pulmicort Turbuhaler|Pulmicort Turbuhaler
431739|NCT00536731|E2|Reported Event|Symbicort Turbuhaler|Symbicort Turbuhaler
431740|NCT00536731|E1|Reported Event|Symbicort pMDI|Symbicort pMDI
431741|NCT00538304|B3|Baseline|Total|Total of all reporting groups
431742|NCT00538304|B2|Baseline|Placebo|Placebo
431743|NCT00538304|B1|Baseline|Bimatoprost Eye Drops|Bimatoprost eye drops
431744|NCT00538304|P2|Participant Flow|Placebo|Placebo
431745|NCT00538304|P1|Participant Flow|Bimatoprost Eye Drops|Bimatoprost eye drops
431746|NCT00538304|O2|Outcome|Placebo|Placebo
431747|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431748|NCT00538304|O2|Outcome|Placebo|Placebo
431749|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431750|NCT00538304|O2|Outcome|Placebo|Placebo
431751|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431752|NCT00538304|O2|Outcome|Placebo|Placebo
431753|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431754|NCT00538304|O2|Outcome|Placebo|Placebo
431755|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431756|NCT00538304|O2|Outcome|Placebo|Placebo
431757|NCT00538304|O1|Outcome|Bimatoprost Eye Drops|Bimatoprost eye drops
431758|NCT00538304|E2|Reported Event|Placebo|Placebo
431759|NCT00538304|E1|Reported Event|Bimatoprost Eye Drops|Bimatoprost eye drops
431760|NCT00538291|B1|Baseline|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
431761|NCT00538291|P1|Participant Flow|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
431762|NCT00538291|O1|Outcome|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
431763|NCT00538291|E1|Reported Event|Arm 1|Cetuximab 400mg/m2 IV on day 1 over 2 hours then 250 mg/m2 over 1 hour weekly + Xeloda(Capecitabine) 1000mg/m2 BID on days 1-14 repeated every 21 days.
431764|NCT00538213|B4|Baseline|Total|Total of all reporting groups
431765|NCT00538213|B3|Baseline|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431766|NCT00538213|B2|Baseline|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431767|NCT00538213|B1|Baseline|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431768|NCT00538213|P3|Participant Flow|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431769|NCT00538213|P2|Participant Flow|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431770|NCT00538213|P1|Participant Flow|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431771|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431772|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431773|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431774|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431775|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431776|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431777|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431778|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431779|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431780|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431781|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431782|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431783|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431784|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431785|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431786|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431787|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431788|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431789|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431790|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
432227|NCT00537745|B1|Baseline|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
431791|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431792|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431793|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431794|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431795|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431796|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431797|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431798|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431799|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431800|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431801|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431802|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431803|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431804|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431805|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431806|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431807|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431808|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431809|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431810|NCT00538213|O3|Outcome|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431811|NCT00538213|O2|Outcome|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431812|NCT00538213|O1|Outcome|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A in this study.
431813|NCT00538213|E3|Reported Event|Fluarix Young Group|Subjects aged 19-42 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431814|NCT00538213|E2|Reported Event|Fluarix Elderly Group|Subjects aged ≥ 66 years who previously received 1 dose of Fluarix vaccine in NCT00318149 and NCT00386698 studies were administered 1 dose of Fluarix vaccine.
431815|NCT00538213|E1|Reported Event|Adjuvanted Influenza Vaccine GSK576389A Group|Subjects aged ≥ 66 years who previously received 1 dose of adjuvanted influenza vaccine GSK576389A in NCT00318149 and NCT00386698 studies were administered 1 dose of adjuvanted influenza vaccine GSK576389A.
431816|NCT00537979|B3|Baseline|Total|Total of all reporting groups
431817|NCT00537979|B2|Baseline|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431818|NCT00537979|B1|Baseline|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431819|NCT00537979|P2|Participant Flow|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431820|NCT00537979|P1|Participant Flow|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431821|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431822|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
432228|NCT00537745|P1|Participant Flow|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
431823|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
431824|NCT00537979|O1|Outcome|Per-Protocol Population|The per-protocol population was defined as all participants who fulfilled inclusion criteria, had intact parathyroid hormone (iPTH) values greater than or equal to 300 pg/mL at baseline, and completed the study with a final iPTH determination. For this outcome measure, the group evaluated included both participants on hemodialysis receiving paricalcitol injection and those on peritoneal dialysis receiving paricalcitol capsules.
431825|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431826|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431827|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431828|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431829|NCT00537979|O2|Outcome|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431830|NCT00537979|O1|Outcome|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431831|NCT00537979|E2|Reported Event|Paricalcitol Capsules|Paricalcitol (ABT-358 Zemplar) capsules were administered to participants on peritoneal dialysis.
431832|NCT00537979|E1|Reported Event|Paricalcitol Injection|Paricalcitol (ABT-358 Zemplar) Injection was administered to participants on hemodialysis.
431833|NCT00537940|B3|Baseline|Total|Total of all reporting groups
431834|NCT00537940|B2|Baseline|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431835|NCT00537940|B1|Baseline|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431836|NCT00537940|P2|Participant Flow|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431837|NCT00537940|P1|Participant Flow|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431838|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431869|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
431870|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
431839|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431840|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431841|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431842|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431843|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431844|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431845|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431846|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431871|NCT00536510|E2|Reported Event|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
431847|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431848|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431849|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431850|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431851|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431852|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431853|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431854|NCT00537940|O2|Outcome|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431872|NCT00536510|E1|Reported Event|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
431855|NCT00537940|O1|Outcome|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431856|NCT00537940|E2|Reported Event|Gabapentin|Gabapentin was initiated at 300 mg/day [100 mg capsules orally three times a day (TID)] followed by gabapentin 600 mg/day (200 mg TID) on Day 3. At the end of Week 1 (Day 7), the dose was increased to 1200 mg/day (400 mg TID) and remained on this dose for the next 4 weeks). Participants who had adequate seizure control (>=50% reduction in seizure frequency) with acceptable tolerability during this initial 5-week period, remained on this dose until the end of theTP (Week 9), then entered the MP on this dose. If seizure control was inadequate, the gabapentin dose was escalated to 1500 mg/day (500 mg TID) during Weeks 5 through 9. If they had adequate seizure control with acceptable tolerability on this dose, they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 1800 mg/day (600 mg TID), at which time they entered the MP.
431857|NCT00537940|E1|Reported Event|Pregabalin|Pregabalin was initiated at 150 mg/day [50 mg capsules orally three times a day (TID)] for 1 Week followed by pregabalin 300 mg/day (100 mg TID) orally TID up to Week 5 in the Titration Phase (TP). Participants who had adequate seizure control (adequate: >=50% reduction in seizures) with acceptable tolerability with pregabalin 300 mg/day in TP, continued same dose until the end of TP (Week 9) and then entered the maintenance phase (MP) on this dose. If seizure control was inadequate, the pregabalin dose was escalated to 450 mg/day orally (150 mg TID) from Weeks 5 through 9. If the participants had adequate seizure control with acceptable tolerability on this dose, then they entered the MP on this dose. If there was inadequate seizure control at the end of Week 9, the dose was escalated a final time to 600 mg/day (200 mg TID) at which time they entered the MP.
431858|NCT00536575|B1|Baseline|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
431859|NCT00536575|P1|Participant Flow|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
431860|NCT00536575|O1|Outcome|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
431861|NCT00536575|E1|Reported Event|Sorafenib/Bortezomib|The trial was designed as a single-arm Phase I/II study of sorafenib and bortezomib with dose optimization in initial patients. Phase I consisted of cohorts of 3 patients at each of three dose levels. Patients received bortezomib (Dose Level 1 - 1.3 mg/m2; Dose Level 2 - 1.6 mg/m2) by IV bolus on days 1, 8, 15, and 22 of each 5-week cycle with continuous oral dosing of sorafenib at 200 mg twice daily. Dose level 3 was planned as bortezomib 1.6 mg/m2 IV bolus on days 1, 8, 15, and 22 with sorafenib 400 mg by mouth twice daily throughout each 5-week cycle.
431862|NCT00536510|B3|Baseline|Total|Total of all reporting groups
431863|NCT00536510|B2|Baseline|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
431864|NCT00536510|B1|Baseline|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
431865|NCT00536510|P2|Participant Flow|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
431866|NCT00536510|P1|Participant Flow|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
431867|NCT00536510|O2|Outcome|Placebo|"All patients received placebo for a 4 week run-in period before randomization.~Drug: Comparator: placebo~Treatment Period 1: one 20 mg /1 g tablet placebo to laropiprant/niacin once daily for 4 weeks~Treatment Period 2: two 20 mg /1 g tablets of placebo to laropiprant/niacin once daily for 8 weeks."
431868|NCT00536510|O1|Outcome|MK0524A 2 g|"All patients received placebo for a 4 week run-in period before randomization.~Drug: laropiprant/niacin (MK0524A)~Treatment Period 1: one 20 mg /1 g tablet of laropiprant/niacin once daily for 4 weeks.~Treatment Period 2: two 20 mg /1 g tablets of laropiprant/niacin once daily for 8 weeks."
431873|NCT00536484|B3|Baseline|Total|Total of all reporting groups
432229|NCT00537745|O1|Outcome|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
432230|NCT00537745|O1|Outcome|Participants|Intervention Group
431874|NCT00536484|B2|Baseline|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431875|NCT00536484|B1|Baseline|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431876|NCT00536484|P2|Participant Flow|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431877|NCT00536484|P1|Participant Flow|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431878|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431879|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431880|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431881|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431882|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431883|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431884|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431885|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431886|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431887|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431888|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431889|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431890|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431891|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431892|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431893|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431894|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431895|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431896|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431924|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432831|NCT00535587|P3|Participant Flow|Placebo Pill and Exercise|
431897|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431898|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431899|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431900|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431901|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431902|NCT00536484|O2|Outcome|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431903|NCT00536484|O1|Outcome|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431904|NCT00536484|E2|Reported Event|Fesoterodine|All randomized participants were treated with fesoterodine 4mg once daily for the first 2 weeks of treatment. The dose remained at 4 mg once daily or increased to 8 mg once daily for the next 10 weeks based on discussion between investigator and participant.
431905|NCT00536484|E1|Reported Event|Placebo|All randomized participants were treated with placebo once daily for the first 2 weeks of treatment. The dose remained as placebo once daily or changed to matching placebo (for 8 mg) once daily for the next 10 weeks based on discussion between investigator and participant.
431906|NCT00536471|B5|Baseline|Total|Total of all reporting groups
431907|NCT00536471|B4|Baseline|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431908|NCT00536471|B3|Baseline|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431909|NCT00536471|B2|Baseline|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431910|NCT00536471|B1|Baseline|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431911|NCT00536471|P4|Participant Flow|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431912|NCT00536471|P3|Participant Flow|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431913|NCT00536471|P2|Participant Flow|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431914|NCT00536471|P1|Participant Flow|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431915|NCT00536471|O4|Outcome|Placebo (Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431916|NCT00536471|O3|Outcome|Placebo (Not Rescued)|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431917|NCT00536471|O2|Outcome|Duloxetine (Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants were increased to duloxetine 120 mg QD, PO for 6 months
431918|NCT00536471|O1|Outcome|Duloxetine (Not Escalated)|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which participants remained on duloxetine 60 mg QD, PO for 6 months.
431919|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431920|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431921|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431922|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431923|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431925|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431926|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431927|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431928|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431929|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431930|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431931|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431932|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431933|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431934|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431935|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431936|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431937|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431938|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431939|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431940|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431941|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431942|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431943|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431944|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431945|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431946|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431947|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431948|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431949|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431950|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431951|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431952|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432038|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432832|NCT00535587|P2|Participant Flow|Mestinon and Attention Control|
431953|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431954|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431955|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431956|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431957|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431958|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431959|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431960|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431961|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431962|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431963|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431964|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431965|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431966|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431967|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431968|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431969|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431970|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431971|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431972|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431973|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431974|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431975|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431976|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431977|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431978|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431979|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431980|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432207|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
431981|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431982|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431983|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431984|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431985|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431986|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431987|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431988|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431989|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431990|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431991|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431992|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431993|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431994|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431995|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431996|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431997|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
431998|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
431999|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432000|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432001|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432002|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432003|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432004|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432005|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432006|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432007|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432008|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432208|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
432209|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
432833|NCT00535587|P1|Participant Flow|Mestinon & Exercise|
432009|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432010|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432011|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432012|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432013|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432014|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432015|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
432016|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
432017|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
432018|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
432019|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
432020|NCT00536471|O1|Outcome|Group B - Percent of Total Effect|The percentage of the total treatment effect explained by the direct and indirect effects of treatment in the duloxetine 60 mg group.
432021|NCT00536471|O4|Outcome|Group B - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
432022|NCT00536471|O3|Outcome|Group B - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
432023|NCT00536471|O2|Outcome|Group A - Standardized Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression expressed in units of standard deviation in the Duloxetine 60 mg group.
432024|NCT00536471|O1|Outcome|Group A - Ordinary Coefficient|Mathematical estimate of the relationship between the dependent variable and the independent variable from linear regression in the Duloxetine 60 mg group.
432025|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432026|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432027|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432028|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432029|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432030|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432031|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432032|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432033|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432034|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432035|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432036|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432037|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432283|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432039|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432040|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432041|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432042|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432043|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432044|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432045|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432046|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432047|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432048|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432049|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432050|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432051|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432052|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432053|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432054|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432055|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432056|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432057|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432058|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432059|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432060|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432061|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432062|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432063|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432064|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432065|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432066|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432210|NCT00537810|E4|Reported Event|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
432067|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432068|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432069|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432070|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432071|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432072|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432073|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432074|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432075|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432076|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432077|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432078|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432079|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432080|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432081|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432082|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432083|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432084|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432085|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432086|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432087|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432088|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432089|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432090|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432091|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432092|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432093|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432094|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432211|NCT00537810|E3|Reported Event|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
432095|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432096|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432097|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432098|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432099|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432100|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432101|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432102|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432103|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432104|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432105|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432106|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432107|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432108|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432109|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432110|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432111|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432112|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432113|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432114|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432115|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432116|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432117|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432118|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432119|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432120|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432121|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432122|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432212|NCT00537810|E2|Reported Event|Placebo|"Placebo Daily~Placebo: Daily"
432213|NCT00537810|E1|Reported Event|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
432214|NCT00537771|B3|Baseline|Total|Total of all reporting groups
432123|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432124|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432125|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432126|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432127|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432128|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432129|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432130|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432131|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432132|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432133|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432134|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432135|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432136|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432137|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432138|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432139|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432140|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432141|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432142|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432143|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432144|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432145|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432146|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432147|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432148|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432149|NCT00536471|O4|Outcome|Group B - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432150|NCT00536471|O3|Outcome|Group B - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432215|NCT00537771|B2|Baseline|TAM Group|Tamoxifen : 20 mg once daily oral dose
432216|NCT00537771|B1|Baseline|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432151|NCT00536471|O2|Outcome|Group A - Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432152|NCT00536471|O1|Outcome|Group A - Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432153|NCT00536471|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for up to 9 months, may be increased to duloxetine 60 mg QD, PO during the first 3 months as part of a rescue plan with pre-defined criteria (Patients meeting criteria will automatically be assigned to duloxetine 60 mg QD).
432154|NCT00536471|E1|Reported Event|Duloxetine|duloxetine 60 mg every day (QD), by mouth (PO) for 3 months, after which may be increased to duloxetine 120 mg QD, PO for 6 months
432155|NCT00536380|B4|Baseline|Total|Total of all reporting groups
432156|NCT00536380|B3|Baseline|20-mg Desloratadine|20-mg Desloratadine once daily
432157|NCT00536380|B2|Baseline|10-mg Desloratadine|10-mg Desloratadine once daily
432158|NCT00536380|B1|Baseline|5-mg Desloratadine|5-mg Desloratadine once daily
432159|NCT00536380|P3|Participant Flow|20-mg Desloratadine|20-mg Desloratadine once daily
432160|NCT00536380|P2|Participant Flow|10-mg Desloratadine|10-mg Desloratadine once daily
432161|NCT00536380|P1|Participant Flow|5-mg Desloratadine|5-mg Desloratadine once daily
432162|NCT00536380|O3|Outcome|10-mg Desloratadine|10-mg Desloratadine once daily
432163|NCT00536380|O2|Outcome|20-mg Desloratadine|20-mg Desloratadine once daily
432164|NCT00536380|O1|Outcome|5-mg Desloratadine|5-mg Desloratadine once daily
432165|NCT00536380|E3|Reported Event|20-mg Desloratadine|20-mg Desloratadine once daily
432166|NCT00536380|E2|Reported Event|10-mg Desloratadine|10-mg Desloratadine once daily
432167|NCT00536380|E1|Reported Event|5-mg Desloratadine|5-mg Desloratadine once daily
432168|NCT00537823|B3|Baseline|Total|Total of all reporting groups
432169|NCT00537823|B2|Baseline|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
432170|NCT00537823|B1|Baseline|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
432171|NCT00537823|P2|Participant Flow|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2~Week 7, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2"
432172|NCT00537823|P1|Participant Flow|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m2 IV~Oxaliplatin 85 mg/m2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m2~5FU CIVI 1200 mg/m2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m2 IV weekly"
432173|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432174|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432175|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432217|NCT00537771|P2|Participant Flow|TAM Group|Tamoxifen : 20 mg once daily oral dose
432218|NCT00537771|P1|Participant Flow|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432219|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
432176|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432177|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432178|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432179|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432180|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432181|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432182|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432183|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432184|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432185|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432220|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432221|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
432222|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432223|NCT00537771|O2|Outcome|TAM Group|Tamoxifen : 20 mg once daily oral dose
432224|NCT00537771|O1|Outcome|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432225|NCT00537771|E2|Reported Event|TAM Group|Tamoxifen : 20 mg once daily oral dose
432186|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432187|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432188|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432189|NCT00537823|O2|Outcome|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432190|NCT00537823|O1|Outcome|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432191|NCT00537823|E2|Reported Event|Arm 2 K-Ras 12/13 Codon Mutation|"Neoadjuvant Therapy~Weeks 1, 3, 5~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Weeks 1, 3, 5, 9, 11, 13~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~Bevacizumab 5 mg/kg IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2~Week 7, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2"
432192|NCT00537823|E1|Reported Event|Arm 1 - Wildtype|"Neoadjuvant therapy~Week 1~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8 *Cetuximab 250 mg/m^2 IV weekly~Weeks 3, 5, 7~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Wait 3-8 weeks after completion of therapy~Liver resection~Wait 4 weeks or until clinical status allows~Adjuvant Therapy~Week 1, 3, 5, 7, 9, 11, 13, 15~Leucovorin 400 mg/m^2 IV~Oxaliplatin 85 mg/m^2 IV Cetuximab 400 mg/m^2 IV~5FU bolus 400 mg/m^2~5FU CIVI 1200 mg/m^2/day over 46 hours~Weeks 2, 4, 6, 8, 10, 12, 16~*Cetuximab 250 mg/m^2 IV weekly"
432193|NCT00537810|B5|Baseline|Total|Total of all reporting groups
432194|NCT00537810|B4|Baseline|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
432195|NCT00537810|B3|Baseline|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
432196|NCT00537810|B2|Baseline|Placebo|"Placebo Daily~Placebo: Daily"
432197|NCT00537810|B1|Baseline|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
432198|NCT00537810|P4|Participant Flow|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
432199|NCT00537810|P3|Participant Flow|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
432200|NCT00537810|P2|Participant Flow|Placebo|"Placebo Daily~Placebo: Daily"
432201|NCT00537810|P1|Participant Flow|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
432202|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
432203|NCT00537810|O3|Outcome|Placebo/CBTsh|"Placebo and Self-help CBT Placebo daily, Cognitive behavioral self-help manual for binge eating~Self-help CBT + Sibutramine: Cognitive behavioral treatment manual for binge eating Sibutramine 15 mg daily"
432204|NCT00537810|O2|Outcome|Placebo|"Placebo Daily~Placebo: Daily"
432205|NCT00537810|O1|Outcome|Sibutramine|"Sibutramine 15 mg daily~Sibutramine: 15 mg daily"
432206|NCT00537810|O4|Outcome|Sibutramine/CBTsh|"Sibutramine and Self-help CBT 15 mg daily Cognitive behavioral treatment manual for binge eating~Self-help CBT + Placebo: Cognitive behavioral treatment manual for binge eating Placebo daily"
432226|NCT00537771|E1|Reported Event|Arimidex Group|Anastrozole(ARIMIDEX): 1 mg once daily oral dose
432231|NCT00537745|E1|Reported Event|Vivitrol|Vivitrol 380 mg/monthly, plus individual compliance enhancement therapy (Medication Management Therapy).
432232|NCT00537680|B4|Baseline|Total|Total of all reporting groups
432233|NCT00537680|B3|Baseline|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
432234|NCT00537680|B2|Baseline|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
432235|NCT00537680|B1|Baseline|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
432236|NCT00537680|P3|Participant Flow|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
432237|NCT00537680|P2|Participant Flow|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
432238|NCT00537680|P1|Participant Flow|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
432239|NCT00537680|O3|Outcome|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
432240|NCT00537680|O2|Outcome|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
432241|NCT00537680|O1|Outcome|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
432242|NCT00537680|E3|Reported Event|Placebo|Placebo was provided as film-coated tablets that were the same size, weight and appearance as the idebenone tablets.
432243|NCT00537680|E2|Reported Event|High Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 1350 mg/day (2 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 2250 mg/day (2 x 150 mg tablet, t.i.d.)
432244|NCT00537680|E1|Reported Event|Mid Dose Idebenone|25 kg/55 lbs to ≤45 kg/99 lbs: idebenone 450 mg/day (1 x 150 mg tablet, t.i.d.) >45 kg/99 lbs: idebenone 900 mg/day (2 x 150 mg tablet, t.i.d.)
432245|NCT00537511|B1|Baseline|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432246|NCT00537511|P1|Participant Flow|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432247|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432248|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432249|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Participants received daily oral pomalidomide 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432250|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Participants received daily oral pomalidomide 4 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432251|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Participants received daily oral pomalidomide 3 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432252|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Participants received daily oral pomalidomide 1 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432253|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432284|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432285|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432286|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432254|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432255|NCT00537511|O5|Outcome|Pomalidomide (Overall, MTD Phase)|Participants received daily oral pomalidomide 1 mg to 5 mg for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432256|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432257|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432258|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432259|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432260|NCT00537511|O4|Outcome|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432261|NCT00537511|O3|Outcome|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432262|NCT00537511|O2|Outcome|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432263|NCT00537511|O1|Outcome|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432264|NCT00537511|O1|Outcome|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432265|NCT00537511|E5|Reported Event|Pomalidomide (Overall)|Oral pomalidomide 1 mg - 5 mg daily (QD) for 14 consecutive days of a 21-day cycle, in combination with intravenous (IV) cisplatin 25 mg/m^2 and IV etoposide 100 mg/m^2 on Days 1, 2 and 3 of each cycle during the dose-finding phase (Treatment and Extension Periods; 6 cycles in total). Dose escalation followed a standard phase 1 3+3 design. Participants continuing took only their pomalidomide dose (monotherapy) for an additional 3-week Recovery Period (14 days of consecutive dosing followed by 7 days of no study medication). Participants continuing took oral pomalidomide 5 mg QD as monotherapy for 14 consecutive days of each 21-day cycle until disease progression in the Maintenance Phase.
432266|NCT00537511|E4|Reported Event|Pomalidomide 5 mg|Oral pomalidomide 5 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432267|NCT00537511|E3|Reported Event|Pomalidomide 4 mg|Oral pomalidomide 4 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432268|NCT00537511|E2|Reported Event|Pomalidomide 3 mg|Oral pomalidomide 3 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432269|NCT00537511|E1|Reported Event|Pomalidomide 1 mg|Oral pomalidomide 1 mg QD for 14 consecutive days of a 21-day cycle in combination with cisplatin 25 mg/m^2 and etoposide 100 mg/m^2 administered intravenously (IV) on Days 1, 2 and 3 of each cycle during the MTD Phase (6 cycles in total).
432270|NCT00537485|B3|Baseline|Total|Total of all reporting groups
432271|NCT00537485|B2|Baseline|Placebo|transdermal application of placebo, 1 time per day
432272|NCT00537485|B1|Baseline|SPM962|transdermal application of SPM962, 1 time per day
432273|NCT00537485|P2|Participant Flow|Placebo|transdermal application of placebo, 1 time per day
432274|NCT00537485|P1|Participant Flow|SPM962|transdermal application of SPM962, 1 time per day
432275|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432276|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432277|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432278|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432279|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432280|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432281|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432282|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432287|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432288|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432289|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432290|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432291|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432292|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432293|NCT00537485|O2|Outcome|Placebo|transdermal application of placebo, 1 time per day
432294|NCT00537485|O1|Outcome|SPM962|transdermal application of SPM962, 1 time per day
432295|NCT00537485|E2|Reported Event|Placebo|transdermal application of placebo, 1 time per day
432296|NCT00537485|E1|Reported Event|SPM962|transdermal application of SPM962, 1 time per day
432297|NCT00537407|B6|Baseline|Total|Total of all reporting groups
432298|NCT00537407|B5|Baseline|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432299|NCT00537407|B4|Baseline|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432300|NCT00537407|B3|Baseline|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432301|NCT00537407|B2|Baseline|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432302|NCT00537407|B1|Baseline|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432303|NCT00537407|P5|Participant Flow|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432304|NCT00537407|P4|Participant Flow|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432305|NCT00537407|P3|Participant Flow|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432306|NCT00537407|P2|Participant Flow|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432307|NCT00537407|P1|Participant Flow|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432308|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432309|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432357|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432310|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432311|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432312|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432313|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432314|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432315|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432316|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432317|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432318|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432319|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432320|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432321|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432322|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432323|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432324|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432411|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432325|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432326|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432327|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432328|NCT00537407|O5|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432329|NCT00537407|O4|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432330|NCT00537407|O3|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432331|NCT00537407|O2|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432332|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432333|NCT00537407|O2|Outcome|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432334|NCT00537407|O1|Outcome|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432335|NCT00537407|O3|Outcome|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432336|NCT00537407|O2|Outcome|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432337|NCT00537407|O1|Outcome|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432338|NCT00537407|E5|Reported Event|Treatment Arm E|"Debio 025 (alisporivir) orally at a loading dose of 400 mg twice daily for 7 days followed by 400 mg/day for 22 days + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432339|NCT00537407|E4|Reported Event|Treatment Arm D|"Debio 025 (alisporivir) 800 mg orally once daily + peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432517|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
432518|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
432340|NCT00537407|E3|Reported Event|Treatment Arm C|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg sc once weekly for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432341|NCT00537407|E2|Reported Event|Treatment Arm B|"Debio 025 (alisporivir) 400 mg orally once daily for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432342|NCT00537407|E1|Reported Event|Treatment Arm A|"Debio 025 (alisporivir) 400 mg orally once daily + peg-IFNα2a 180 μg subcutaneously (sc) once weekly + ribavirin 1000 or 1200 mg/day orally for 29 days followed by peg-IFNα2a 180 μg sc once weekly + ribavirin 1000 or 1200 mg/day orally administered for 44 or 68 weeks depending upon response~Debio 025: Debio 025 supplied as a 100 mg/mL oral solution~Peg-IFNα2a: Peg-IFNa2a supplied in 180 μg/0.5 mL prefilled syringes~Ribavirin: Ribavirin supplied as 200 mg tablets"
432343|NCT00537394|B4|Baseline|Total|Total of all reporting groups
432344|NCT00537394|B3|Baseline|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
432345|NCT00537394|B2|Baseline|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432346|NCT00537394|B1|Baseline|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432347|NCT00537394|P3|Participant Flow|Non-randomized Group: Add NRTIs to Individual Regimen cPSS <=2|[Non-randomized Group C] : Among persons whose ARV resistance and history profile precluded any of the 20 possible ARV regimens having high enough potential potency (cPSS <=2), treatment was assigned rather than being a randomized. To their regimen, individualized NRTI combination of at least 2 drugs from this class were added in order to form the most potent ARV regimen possible.
432348|NCT00537394|P2|Participant Flow|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|[Arm B] Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432349|NCT00537394|P1|Participant Flow|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|[Arm A]Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432350|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432351|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432352|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432353|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432354|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432355|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432356|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432358|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432359|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432360|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432361|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432362|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432363|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432364|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432365|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432366|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432367|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432368|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432369|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432370|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432371|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432372|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432373|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432519|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
432520|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
432374|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432375|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432376|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432377|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432378|NCT00537394|O2|Outcome|Omit NRTIs (Randomized) From Individualized Regimen(cPSS > 2)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432379|NCT00537394|O1|Outcome|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432380|NCT00537394|E2|Reported Event|Omit NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was omitted, and any NRTIs the participant had been taking prior to randomization were to be permanently discontinued.
432381|NCT00537394|E1|Reported Event|Add NRTIs (Randomized) to Individualized Regimen (cPSS > 2.0)|Individualized ARV study regimen with antiretroviral potency defined as continuous phenotype sensitivity score (cPSS) greater than 2.0 recommended and chosen prior to randomization. To this regimen, an individualized NRTI combination of at least 2 drugs from this class, chosen prior to randomization, was also started.
432382|NCT00537381|B3|Baseline|Total|Total of all reporting groups
432383|NCT00537381|B2|Baseline|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432384|NCT00537381|B1|Baseline|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432385|NCT00537381|P2|Participant Flow|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432386|NCT00537381|P1|Participant Flow|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432387|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432388|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432389|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432390|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432521|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
432522|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
432391|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432392|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432393|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432394|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432395|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432396|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432397|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432398|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432399|NCT00537381|O2|Outcome|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432400|NCT00537381|O1|Outcome|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432401|NCT00537381|E4|Reported Event|Docetaxel + Prednisone + Placebo/ D+ P + Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to Docetaxel (D) + Prednisone (P) + intetumumab (9 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily till disease progression.
432402|NCT00537381|E3|Reported Event|Docetaxel + Prednisone + Placebo/ Intetumumab|Participants who initially received Docetaxel + Prednisone + Placebo until disease progression were switched their treatment to intetumumab alone (2 participants) and received intetumumab 10 mg/kg as intravenous infusion every 3 weeks till disease progression.
432403|NCT00537381|E2|Reported Event|Docetaxel + Prednisone + Intetumumab|Intetumumab 10 mg per kilogram (mg/kg) as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 mg/m^2 as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression.
432404|NCT00537381|E1|Reported Event|Docetaxel + Prednisone + Placebo|Matching placebo as intravenous infusion every week for initial 6 weeks, then every 3 weeks; along with docetaxel 75 milligram per square meter (mg/m^2) as intravenous infusion every 3 weeks and prednisone 5 mg orally twice daily were administered till 6 months or disease progression. Participants with disease progression at any time had option to crossover to alternative treatment with intetumumab alone or intetumumab in combination with docetaxel and prednisone.
432405|NCT00537329|B1|Baseline|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432406|NCT00537329|P1|Participant Flow|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432407|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432408|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432409|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432410|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432523|NCT00537095|O1|Outcome|ZD6474|ZD6474, Vandetanib 300mg
432412|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432413|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432414|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432415|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432416|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432417|NCT00537329|O1|Outcome|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432418|NCT00537329|E1|Reported Event|Anidulafungin|Single 200 milligram (mg) intravenous (IV) dose of anidulafungin, followed by anidulafungin 100 mg IV once daily (QD) for a minimum of 5 days but not more than 42 days.
432419|NCT00537316|B7|Baseline|Total|Total of all reporting groups
432420|NCT00537316|B6|Baseline|Intermittent IFX (During Part 2)|Participants enrolled directly and randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA daily in Part 2 of the study (1 participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
432421|NCT00537316|B5|Baseline|Intermittent IFX/AZA (During Part 2)|Participants enrolled directly and randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
432422|NCT00537316|B4|Baseline|Maintenance IFX/AZA (During Part 2)|Participants enrolled directly and randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study).
432423|NCT00537316|B3|Baseline|IFX/AZA|"All treated participants. IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
432424|NCT00537316|B2|Baseline|Azathioprine (AZA)|All treated participants. AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
432425|NCT00537316|B1|Baseline|Infliximab (IFX)|All treated participants. IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432426|NCT00537316|P7|Participant Flow|Intermittent IFX (During Part 2)|Participants randomized to intermittent IFX received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) and placebo to AZA as allocated in Part 1 of the study (1 participant from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
432427|NCT00537316|P6|Participant Flow|Intermittent IFX/AZA (During Part 2)|Participants randomized to intermittent IFX/AZA received IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (3 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
432428|NCT00537316|P5|Participant Flow|Maintenance IFX (During Part 2)|Participants randomized to maintenance IFX received infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) and placebo to AZA therapy as allocated in Part 1 of the study (all participants were from Part 1 of the study).
432429|NCT00537316|P4|Participant Flow|Maintenance IFX/AZA (During Part 2)|Participants randomized to maintenance IFX/AZA received IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily in Part 2 of the study (4 participants from Part 1 of the study and 1 participant was enrolled directly into Part 2 of the study).
432430|NCT00537316|P3|Participant Flow|IFX/AZA|"IFX 5 mg/kg IV infusion at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more IFX infusion at Week 14; non-responders to IFX/AZA will receive placebo IFX infusions at Weeks 8 and 10 and one additional IFX infusion at Week 14."
432431|NCT00537316|P2|Participant Flow|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 16 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one placebo IFX infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive IFX at Weeks 8, 10, and 14. This group included 20 participants who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
432432|NCT00537316|P1|Participant Flow|Infliximab (IFX)|IFX 5 mg/kg Intravenous (IV) infusions administered at Weeks 0, 2, and 6 and placebo to AZA (orally) daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432433|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
432434|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
432435|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432436|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
432437|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
432438|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432439|NCT00537316|O3|Outcome|IFX/AZA|"IFX 5 mg/kg IV at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; non-responders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
432440|NCT00537316|O2|Outcome|Azathioprine (AZA)|AZA 2.5 mg/kg orally for 14 weeks and placebo to IFX infusion at Weeks 0, 2, and 6. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14. This group included 20 subjects who did not respond to AZA monotherapy at Week 8 had IFX added to their treatment regimen at Weeks 8, 10, and 14.
432441|NCT00537316|O1|Outcome|Infliximab (IFX)|IFX 5 mg/kg IV infusions administered at Weeks 0, 2, and 6 and placebo to AZA daily for 16 weeks. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432442|NCT00537316|E14|Reported Event|IFX (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight until the end of the study. All participants were from Part 1 of the study.
432443|NCT00537316|E13|Reported Event|IFX/AZA (Part 2)|Participants received IV infusions of IFX 5 mg/kg of body weight every 8 weeks and AZA 2.5 mg/kg of body weight orally daily until the end of the study. All participants were from Part 1 of the study.
432444|NCT00537316|E12|Reported Event|AZA (Part 2)|Participants received AZA 2.5 mg/kg of body weight orally daily for Part 2 of the study. All participants were from Part 1 of the study.
432445|NCT00537316|E11|Reported Event|Intermittent IFX (Part 2)|Participants randomized to intermittent IFX received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained). One participant from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
432446|NCT00537316|E10|Reported Event|Intermittent IFX/AZA (Part 2)|Participants randomized to intermittent IFX/AZA received IV infusions of IFX 5 mg/kg of body weight only upon relapse of disease (initiated at Weeks 0, 2, and 6 of individual treatment cycle and continued every 8 weeks until remission was regained) plus AZA 2.5 mg/kg of body weight daily. Three participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
432447|NCT00537316|E9|Reported Event|Maintenance IFX (Part 2)|Participants randomized to maintenance IFX received IV infusions of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry). All participants were from Part 1 of the study.
432448|NCT00537316|E8|Reported Event|Maintenance IFX/AZA (Part 2)|Participants randomized to maintenance IFX/AZA during Part 2 received IV infusion of IFX 5 mg/kg of body weight every 8 weeks (beginning at Week 22, Week 6 for direct entry) plus AZA 2.5 mg/kg of body weight daily. Four participants were from Part 1 of the study and 1 participant enrolled directly into Part 2 of the study.
432449|NCT00537316|E7|Reported Event|IFX After Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432450|NCT00537316|E6|Reported Event|IFX/AZA After Week 8|"Participants received IV infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
432451|NCT00537316|E5|Reported Event|AZA to IFX/AZA After Week 8|Participants received AZA 2.5 mg/kg orally for 16 weeks and had IV infusions of IFX 5mg/kg of body weight added to their treatment regimen at Weeks 8, 10, and 14. Participants were either non-responders to AZA at Week 8 or had worsening of disease at Week 8.
432452|NCT00537316|E4|Reported Event|AZA After Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
432453|NCT00537316|E3|Reported Event|IFX Through Week 8|Participants received IV infusions of IFX 5 mg/kg of body weight administered at Weeks 0, 2, and 6. Responders to IFX at Week 8, will receive one more IFX infusion at Week 14; non-responders to IFX will receive placebo infusions at Weeks 8 and 10 and an additional IFX infusion at Week 14.
432524|NCT00537095|E2|Reported Event|PLACEBO|PLACEBO
432525|NCT00537095|E1|Reported Event|ZD6474|ZD6474, Vandetanib 300mg
432526|NCT00537082|B4|Baseline|Total|Total of all reporting groups
432527|NCT00537082|B3|Baseline|Placebo|Administered orally once daily for 6 months
432454|NCT00537316|E2|Reported Event|IFX/AZA Through Week 8|"Participants received intravenous (IV) infusions of IFX 5 mg/kg of body weight at Weeks 0, 2, and 6 plus AZA 2.5 mg/kg orally daily for 16 weeks.~Responders to IFX/AZA at Week 8 will receive one more infliximab infusion at Week 14; nonresponders to IFX/AZA will receive placebo infusions at Weeks 8 and 10 and one additional infliximab infusion at Week 14."
432455|NCT00537316|E1|Reported Event|AZA Through Week 8|Participants received AZA 2.5 mg/kg orally daily for 16 weeks. Responders to AZA monotherapy at Week 8 will continue on AZA therapy and receive one infliximab placebo infusion at Week 14; non-responders to AZA at Week 8 will be eligible to receive infliximab at Weeks 8, 10, and 14.
432456|NCT00537303|B3|Baseline|Total|Total of all reporting groups
432457|NCT00537303|B2|Baseline|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432458|NCT00537303|B1|Baseline|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432459|NCT00537303|P2|Participant Flow|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432460|NCT00537303|P1|Participant Flow|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432461|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432462|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432463|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432464|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432465|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432466|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432467|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432468|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432469|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432470|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432471|NCT00537303|O2|Outcome|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432528|NCT00537082|B2|Baseline|FTY720 0.5 mg|Administered orally once daily for 6 months
432472|NCT00537303|O1|Outcome|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432473|NCT00537303|E2|Reported Event|Basic|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the largest meals and individually adjusted insulin aspart based mainly on pre-meal and bedtime SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432474|NCT00537303|E1|Reported Event|Advanced|Insulin detemir once daily + oral anti-diabetic drugs (OADs) with addition of meal-time insulin aspart stepwise (1-2-3) at the meals with the largest prandial increments and individually adjusted insulin aspart based mainly on postmeal SMPG (self monitored plasma glucose). The stepwise addition occurred if the treatment target of HbA1c below 7.0% was not reached after 12, 24 and 36 weeks, respectively.
432475|NCT00537277|B1|Baseline|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432476|NCT00537277|P1|Participant Flow|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432477|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432478|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432479|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432480|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432481|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432482|NCT00537277|O1|Outcome|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432529|NCT00537082|B1|Baseline|FTY720 1.25 mg|Administered orally once daily for 6 months
432483|NCT00537277|E1|Reported Event|BIAsp 30|Subjects received individually adjusted dose of biphasic insulin aspart 30 (BIAsp 30) once daily for 16 weeks. If the treatment target of HbA1c below 7% was reached after 16 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 16, then BIAsp 30 treatment was increased to twice daily for additional 16 weeks. If the treatment target of HbA1c below 7% was reached after 32 weeks of treatment, the subject continued the reached dose until week 48 (end of trial). If the treatment target of HbA1c below 7% was not achieved at week 32, then BIAsp 30 treatment was increased to three times daily for additional 16 weeks until week 48 (end of trial).
432484|NCT00537238|B3|Baseline|Total|Total of all reporting groups
432485|NCT00537238|B2|Baseline|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432486|NCT00537238|B1|Baseline|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432487|NCT00537238|P2|Participant Flow|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432488|NCT00537238|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule orally twice daily (BID) for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the titration phase (TP). If seizure control was inadequate (adequate: at least [>=] 50% reduction in seizures), pregabalin dose was escalated to 225 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week maintenance phase(MP). Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during TP and MP. After MP, participants were allowed to progress into optional (opt) blinded continuation phase, and remained on dose from MP for a maximum of 2 years or until last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432489|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432490|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432491|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432530|NCT00537082|P3|Participant Flow|Placebo|Administered orally once daily for 6 months
432492|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432493|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432494|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432495|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432496|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432497|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432498|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432499|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432531|NCT00537082|P2|Participant Flow|FTY720 0.5 mg|Administered orally once daily for 6 months
432500|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432501|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432502|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432503|NCT00537238|O2|Outcome|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432504|NCT00537238|O1|Outcome|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432505|NCT00537238|E2|Reported Event|Levetiracetam|Levetiracetam 500 mg capsule orally BID for 2 Weeks in the TP. If seizure control was inadequate (adequate: >= 50% reduction in seizures), the levetiracetam dose was escalated to 1000 mg orally BID for Week 2 through Week 4. Participants who had adequate seizure control with levetiracetam 500 or 1000 mg orally BID dose in the TP, continued same dose in the 12-week MP. Participants who had inadequate seizure control, received levetiracetam 1500 mg orally BID during the MP. Participants also received placebo matched to pregabalin capsule orally BID along with levetiracetam during TP and MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on the dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from the MP. Participants underwent an end-of-study medication taper over a 1-week period.
432506|NCT00537238|E1|Reported Event|Pregabalin|Pregabalin 75 mg capsule orally BID for 1 Week followed by pregabalin 150 mg orally BID up to Week 4 in the TP. If seizure control was inadequate (adequate: >=50% reduction in seizures), the pregabalin dose was escalated to 225 mg orally BID for Week 2 through 4. Participants who had adequate seizure control with pregabalin 150 mg or 225 mg orally BID dose in TP, continued same dose during the 12-week MP. Participants who had inadequate seizure control, received pregabalin 300 mg orally BID during the MP. Participants also received placebo matched to levetiracetam capsule orally BID along with pregabalin during the TP and the MP. After the MP, participants were allowed to progress into the opt blinded continuation phase, and remained on dose from the MP for a maximum of 2 years or until the last participant either completed or discontinued from MP. Participants underwent an end-of-study medication taper over a 1-week period.
432507|NCT00537199|B1|Baseline|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
432508|NCT00537199|P1|Participant Flow|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
432509|NCT00537199|O1|Outcome|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
432510|NCT00537199|E1|Reported Event|OraTest + Visual Exam|Visual oral exam, followed by OraTest Rinse Staining Procedure
432511|NCT00537095|B3|Baseline|Total|Total of all reporting groups
432512|NCT00537095|B2|Baseline|PLACEBO|PLACEBO
432513|NCT00537095|B1|Baseline|ZD6474|ZD6474, Vandetanib 300mg
432514|NCT00537095|P2|Participant Flow|PLACEBO|PLACEBO
432515|NCT00537095|P1|Participant Flow|ZD6474|ZD6474, Vandetanib 300mg
432516|NCT00537095|O2|Outcome|PLACEBO|PLACEBO
432532|NCT00537082|P1|Participant Flow|FTY720 1.25 mg|Administered orally once daily for 6 months
432533|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
432534|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
432535|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
432536|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
432537|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
432538|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
432539|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
432540|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
432541|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
432542|NCT00537082|O3|Outcome|Placebo|Administered orally once daily for 6 months
432543|NCT00537082|O2|Outcome|FTY720 0.5 mg|Administered orally once daily for 6 months
432544|NCT00537082|O1|Outcome|FTY720 1.25 mg|Administered orally once daily for 6 months
432545|NCT00537082|E3|Reported Event|Placebo|Administered orally once daily for 6 months
432546|NCT00537082|E2|Reported Event|FTY720 0.5mg|Administered orally once daily for 6 months
432547|NCT00537082|E1|Reported Event|FTY720 1.25mg|Administered orally once daily for 6 months
432548|NCT00537030|B1|Baseline|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
432549|NCT00537030|P1|Participant Flow|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
432550|NCT00537030|O1|Outcome|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
432551|NCT00537030|E1|Reported Event|Erwinia Asparaginase|"Patients receive 6 doses of Erwinia asparaginase (dosage 25,000 IU/m2 intramuscularly (IM) on a Monday/Wednesday/Friday schedule as a replacement for each scheduled dose of PEG-asparaginase remaining on the original treatment protocol. All other chemotherapy continues according to the original treatment protocol.~pharmacological study : Correlative studies~laboratory biomarker analysis : Correlative studies~asparaginase : Given IM"
432552|NCT00537017|B1|Baseline|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432553|NCT00537017|P1|Participant Flow|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432554|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432555|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432556|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432557|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432558|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432559|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432560|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432561|NCT00537017|O1|Outcome|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432562|NCT00537017|E1|Reported Event|Preladenant 5 mg BID|Preladenant 5 mg BID given open-label for 36 weeks to participants with moderate to severe Parkinson's Disease who are on a long-term and stable L-dopa treatment regimen.
432563|NCT00536978|B1|Baseline|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
432595|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432596|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432597|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432564|NCT00536978|P1|Participant Flow|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
432565|NCT00536978|O1|Outcome|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
432566|NCT00536978|E1|Reported Event|NK Cell/T-Cell Infusion|Possible Cell Adback - infusion NK cells or T-cells from donor given after blood stem cell transplantation for either Reduced intensity chemotherapy of campath, modified BEAM regimen of Campath-IH 15 mg intravenous (IV) Daily for 3 Days + BEAM Daily for 4 days (BCNU 300 mg/m^2 IV, Etoposide 100 mg/m^2 IV, Ara-C 100 mg/m^2 IV Daily for 4 days and Melphalan 100 mg/m^2 IV Over 30 Minutes for 1 Day) + Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks]; or Non-myeloablative Preparative Regimen [Fludarabine 30 mg/m^2 IV Daily Over 1 Hour for 3 Days; Cyclophosphamide 1000 mg/m^2 IV Daily Over 1 Hour for 3 Days; Rituximab 375 mg/m^2 IV Over 5-7 Hours for 1 Day, followed by 1000 mg/m^2 IV Over 5-7 Hours Weekly for 3 Weeks; Campath-IH 15 mg IV Daily Over 30 Minutes for 3 Days; plus Total Body radiation (TBI)].
432567|NCT00536341|B3|Baseline|Total|Total of all reporting groups
432568|NCT00536341|B2|Baseline|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
432569|NCT00536341|B1|Baseline|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
432570|NCT00536341|P2|Participant Flow|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
432571|NCT00536341|P1|Participant Flow|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
432572|NCT00536341|O1|Outcome|All Patients|
432573|NCT00536341|O1|Outcome|All Patients|
432574|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
432575|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
432576|NCT00536341|O2|Outcome|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
432577|NCT00536341|O1|Outcome|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
432578|NCT00536341|E2|Reported Event|Dose Level 2|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 cycle 1, 5.0 mg PO days 8-28 cycles 2-6
432579|NCT00536341|E1|Reported Event|Dose Level 1|Rituximab 375 mg/m^2 cycle 1 (split over Day 1 & Day 2), 500 mg/m^2 Day 1 of cycles 2-6 Fludarabine 25 mg/m^2 on days 1, 2 and 3 Lenalidomide 2.5 mg PO daily Days 8-28 all cycles 1-6
432580|NCT00536263|B4|Baseline|Total|Total of all reporting groups
432581|NCT00536263|B3|Baseline|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up; treated participants.
432582|NCT00536263|B2|Baseline|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
432583|NCT00536263|B1|Baseline|PEG 1.0 mcg/kg QW * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up; treated participants
432584|NCT00536263|P3|Participant Flow|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432585|NCT00536263|P2|Participant Flow|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432586|NCT00536263|P1|Participant Flow|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432587|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432588|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432589|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432590|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432591|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432592|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432593|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432594|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432598|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432599|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432600|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432601|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432602|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432603|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432604|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432605|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432606|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432607|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432608|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432609|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432610|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432611|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432612|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432613|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432614|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432615|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432616|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432617|NCT00536263|O3|Outcome|PEG 1.5 mcg/kg QW * 48 Weeks|PegIntron 1.5 mcg/kg QW * 48 weeks + 24 weeks follow-up
432618|NCT00536263|O2|Outcome|PEG 1.5 mcg/kg QW * 24 Weeks|PegIntron 1.5 mcg/kg QW * 24 weeks + 24 weeks follow-up
432619|NCT00536263|O1|Outcome|PEG 1.0 mcg/kg Weekly (QW) * 24 Weeks|PegIntron 1.0 mcg/kg QW * 24 weeks + 24 weeks follow-up
432620|NCT00536263|E3|Reported Event|PEG 1.5 mcg/kg QW x48 Weeks|
432621|NCT00536263|E2|Reported Event|PEG 1.5 mcg/kg QW x24 Weeks|
432622|NCT00536263|E1|Reported Event|PEG 1.0 mcg/kg QW x24 Weeks|
432623|NCT00536198|B3|Baseline|Total|Total of all reporting groups
432624|NCT00536198|B2|Baseline|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432625|NCT00536198|B1|Baseline|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432626|NCT00536198|P2|Participant Flow|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432627|NCT00536198|P1|Participant Flow|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432628|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432629|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432630|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432631|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432632|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432726|NCT00535938|E2|Reported Event|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432727|NCT00535938|E1|Reported Event|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432633|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432634|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432635|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432636|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432637|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432638|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432639|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432640|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432641|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432642|NCT00536198|O2|Outcome|Placebo|Participants will take similarly looking placebo during the symptomatic period Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg.
432643|NCT00536198|O1|Outcome|Sertraline|Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue.
432644|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432645|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432646|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432647|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432648|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432673|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432649|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432650|NCT00536198|O2|Outcome|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432651|NCT00536198|O1|Outcome|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432652|NCT00536198|E2|Reported Event|Placebo|"Participants will take similarly looking placebo during the symptomatic period~Placebo: 50 mg of placebo will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg."
432653|NCT00536198|E1|Reported Event|Sertraline|"Participants will take sertraline that is dosed between 50 and 100 mgs during the symptomatic period~Sertraline: 50 mg of sertraline will be taken at the onset of premenstrual symptoms through the first few days of menses. If a participant shows an insufficient response to this dose, the dose may be increased to 100 mg. Women who report moderate to severe side effects will be allowed to reduce their dose to 25 mg of sertraline and to increase the dose at the next cycle unless rate-limiting side effects continue."
432654|NCT00536172|B3|Baseline|Total|Total of all reporting groups
432655|NCT00536172|B2|Baseline|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
432656|NCT00536172|B1|Baseline|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
432657|NCT00536172|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
432658|NCT00536172|P1|Participant Flow|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
432659|NCT00536172|O2|Outcome|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
432660|NCT00536172|O1|Outcome|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
432661|NCT00536172|E2|Reported Event|Placebo|"Participants will receive treatment with placebo~Placebo: Placebo distribution matches the active medication."
432662|NCT00536172|E1|Reported Event|Escitalopram|"Participants will receive treatment with escitalopram~Escitalopram: Participants take 10 mg for 1 week and then 20 mg for 15 weeks."
432663|NCT00536120|B3|Baseline|Total|Total of all reporting groups
432664|NCT00536120|B2|Baseline|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
432665|NCT00536120|B1|Baseline|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432666|NCT00536120|P2|Participant Flow|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
432667|NCT00536120|P1|Participant Flow|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432668|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432669|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432670|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432671|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432672|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
432674|NCT00536120|O2|Outcome|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at Month 0 for both KLH and Td, and 14 and 28 days later for KLH. They did not receive any treatment for their MS and remained in the study through Month 2.
432675|NCT00536120|O1|Outcome|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at Month 6 (following the 7th dose of Tysabri) for both KLH and Td, and 14 and 28 days later for KLH.
432676|NCT00536120|E2|Reported Event|Vaccinations Only|Participants received only vaccinations with neoantigen and recall antigen (KLH and Td, according to manufacturer's prescribing information) at specified timepoints. They did not receive any treatment for their MS.
432677|NCT00536120|E1|Reported Event|Tysabri Plus Vaccinations|Participants received 9 monthly doses of Tysabri 300 mg intravenous (IV), and received vaccinations with neoantigen and recall antigen (keyhole limpet hemocyanin [KLH] and tetanus diphtheria toxoid [Td], according to manufacturer's prescribing information) at specified timepoints following the 7th dose.
432678|NCT00536107|B3|Baseline|Total|Total of all reporting groups
432679|NCT00536107|B2|Baseline|Docetaxel|docetaxel 60mg/m sq
432680|NCT00536107|B1|Baseline|Gefitinib|gefitinib 250mg
432681|NCT00536107|P2|Participant Flow|Docetaxel|docetaxel 60mg/m sq
432682|NCT00536107|P1|Participant Flow|Gefitinib|gefitinib 250mg
432683|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
432684|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
432685|NCT00536107|O2|Outcome|Docetaxel|docetaxel 60mg/m sq
432686|NCT00536107|O1|Outcome|Gefitinib|gefitinib 250mg
432687|NCT00536107|E2|Reported Event|Docetaxel|docetaxel 60mg/m sq
432688|NCT00536107|E1|Reported Event|Gefitinib|gefitinib 250mg
432689|NCT00535938|B3|Baseline|Total|Total of all reporting groups
432690|NCT00535938|B2|Baseline|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432691|NCT00535938|B1|Baseline|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432692|NCT00535938|P2|Participant Flow|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432693|NCT00535938|P1|Participant Flow|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432694|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432695|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432696|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432697|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432698|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432699|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432700|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432701|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432702|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432703|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432704|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432705|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432706|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432707|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432708|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432709|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432710|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432711|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432712|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432713|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432714|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432715|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432716|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432717|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432718|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432719|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432720|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432721|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432722|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432723|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432724|NCT00535938|O2|Outcome|Non-naïve to Botox® Treatment|Receiving ongoing treatment with BOTOX® upon entry to the project.
432725|NCT00535938|O1|Outcome|Naïve to Botox® Treatment|Initiating treatment with BOTOX® upon entry to the project.
432728|NCT00535873|B1|Baseline|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
432729|NCT00535873|P1|Participant Flow|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
432730|NCT00535873|O1|Outcome|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
432731|NCT00535873|E1|Reported Event|Lenalidomide|Lenalidomide starting dose of 5 mg (capsules) by mouth daily for 28 days, one cycle.
432732|NCT00535847|B4|Baseline|Total|Total of all reporting groups
432733|NCT00535847|B3|Baseline|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432734|NCT00535847|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432735|NCT00535847|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432736|NCT00535847|P3|Participant Flow|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432737|NCT00535847|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432738|NCT00535847|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432739|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432740|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432741|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432742|NCT00535847|O4|Outcome|Did Not Achieve eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who neither achieved eRVR nor SVR in this study (VX06-950-107 [NCT00535847]).
432743|NCT00535847|O3|Outcome|Did Not Achieve eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who did not achieve eRVR but achieved SVR in this study (VX06-950-107 [NCT00535847]).
432744|NCT00535847|O2|Outcome|Achieved eRVR/Did Not Achieve SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR but did not achieve SVR in this study (VX06-950-107 [NCT00535847]).
432745|NCT00535847|O1|Outcome|Achieved eRVR/Achieved SVR|All subjects in “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week” and “Other” reporting groups who achieved eRVR and SVR in this study (VX06-950-107 [NCT00535847]).
432746|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432747|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432748|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432749|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432750|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432751|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432752|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432753|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432754|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432755|NCT00535847|O3|Outcome|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432756|NCT00535847|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432757|NCT00535847|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432758|NCT00535847|E3|Reported Event|Other|"Subjects received telaprevir 750 mg tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects <75 kg and 1200 mg/day for subjects weighing >=75 kg, discontinued treatment before Week 12 in this study (VX06-950-107 [NCT00535847]) and had a partial response, viral breakthrough, or relapse in the parent study (VX05-950-104 [NCT00336479], VX05-950-104EU [NCT00372385] or VX06-950-106 [NCT00420784]) were included in Other reporting group."
432759|NCT00535847|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
432760|NCT00535847|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Telaprevir 750 mg tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
432761|NCT00535821|B3|Baseline|Total|Total of all reporting groups
432762|NCT00535821|B2|Baseline|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
432763|NCT00535821|B1|Baseline|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
432764|NCT00535821|P2|Participant Flow|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
432765|NCT00535821|P1|Participant Flow|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
432766|NCT00535821|O2|Outcome|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
432767|NCT00535821|O1|Outcome|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
432768|NCT00535821|E2|Reported Event|EGDT|"A 6-hour resuscitation protocol utilizing CVP/ScvO2~Central line with CVP and continuous ScvO2 monitoring: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by CVP and ScvO2 monitoring"
432769|NCT00535821|E1|Reported Event|MiCHO|"A 6-hour resuscitation protocol utilizing the esophageal Doppler monitoring (EDM)~Esophageal Doppler monitoring - CardioQ, Deltex Inc: 6-hour hemodynamic optimization of severe sepsis or septic shock guided by EDM"
432770|NCT00535782|B3|Baseline|Total|Total of all reporting groups
432771|NCT00535782|B2|Baseline|Placebo + MTX|During Part 1 of the study participants received placebo intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received 8 mg/kg TCZ IV every 4 weeks plus 7.5-25 mg MTX weekly.
432772|NCT00535782|B1|Baseline|TCZ + MTX|During Part 1 of the study participants received 8 mg/kg tocilizumab (TCZ) by intravenous (IV) infusion every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks. During Part 2, from Week 24 to Week 104, participants received open-label 8 mg/kg TCZ every 4 weeks plus 7.5-25 mg MTX weekly.
432773|NCT00535782|P3|Participant Flow|Part 2: TCZ + MTX|During Part 2 of the study, from Week 24 to Week 104, all participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
432774|NCT00535782|P2|Participant Flow|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
432775|NCT00535782|P1|Participant Flow|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
432776|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
432777|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
432778|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
432779|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
432780|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
432781|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
432782|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
432783|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
432784|NCT00535782|O2|Outcome|Placebo + MTX|Participants received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for the first 24 weeks.
432785|NCT00535782|O1|Outcome|TCZ + MTX|Participants received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus 7.5-25 mg of methotrexate (MTX) weekly for the first 24 weeks.
432786|NCT00535782|E3|Reported Event|All TCZ + MTX|Includes patients who received at least one dose of active tocilizumab (TCZ) regardless of when they received it during the study and whether it was double-blind (Part 1) or open-label (Part 2). Participants received 8 mg/kg TCZ by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly.
432787|NCT00535782|E2|Reported Event|Part 1: Placebo + MTX|During Part 1 of the study participants in this group received placebo intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
432788|NCT00535782|E1|Reported Event|Part 1: TCZ + MTX|During Part 1 of the study participants in this group received 8 mg/kg tocilizumab (TCZ) by intravenous infusion (IV) every 4 weeks plus methotrexate (MTX) 7.5-25 mg (oral or parenteral) weekly for 24 weeks.
432789|NCT00535769|B3|Baseline|Total|Total of all reporting groups
432790|NCT00535769|B2|Baseline|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432791|NCT00535769|B1|Baseline|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432792|NCT00535769|P2|Participant Flow|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432793|NCT00535769|P1|Participant Flow|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432823|NCT00535652|O1|Outcome|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
432824|NCT00535652|E1|Reported Event|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
432825|NCT00535587|B5|Baseline|Total|Total of all reporting groups
432794|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432795|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432796|NCT00535769|O1|Outcome|Usefulness of Text Messaging System|Patients with text reminder system were asked their opinion of the usefulness of message reminder from 0-10 (0, not useful at all; 10,most useful)
432797|NCT00535769|O2|Outcome|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432798|NCT00535769|O1|Outcome|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432799|NCT00535769|E2|Reported Event|Electronic Monitor + Text Message|The text message group of subjects will receive the study sunscreen with the attached electronic monitor. In addition, this group will receive daily text messages on their cellular phone to remind them to apply the sunscreen. The text message will also contain the daily weather information. This group will also be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432800|NCT00535769|E1|Reported Event|Control: Electronic Monitor+ no Text Message|The control group of subjects will receive the study sunscreen with the attached electronic monitor. They will be instructed to apply sunscreen once a day in the morning to the sun-exposed areas of the body. If the subjects are to have continuous sun exposure (for example, at a beach), they are to re-apply the sunscreen every 3 hours.
432801|NCT00535730|B3|Baseline|Total|Total of all reporting groups
432802|NCT00535730|B2|Baseline|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432803|NCT00535730|B1|Baseline|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432804|NCT00535730|P2|Participant Flow|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432805|NCT00535730|P1|Participant Flow|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432806|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432807|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432808|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432809|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432810|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432811|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432812|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432813|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432814|NCT00535730|O1|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432815|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432816|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432817|NCT00535730|O2|Outcome|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432818|NCT00535730|O1|Outcome|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432819|NCT00535730|E2|Reported Event|Concomitant Group|Subjects were administered ZOSTAVAX™ subcutaneously concomitantly with PNEUMOVAX™ 23 intramuscularly at separate injection sites at Day 1
432820|NCT00535730|E1|Reported Event|Nonconcomitant Group|Subjects were administered PNEUMOVAX™ 23 intramuscularly on Day 1 followed by ZOSTAVAX™ subcutaneously on Week 4
432821|NCT00535652|B1|Baseline|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
432822|NCT00535652|P1|Participant Flow|Ertapenem|"Administration of 1 gram ertapenem I.V.~Ertapenem: powder for infusion, 1 gram I.V., single dose over 30 min."
432826|NCT00535587|B4|Baseline|Placebo Pill and Attention Control|
432834|NCT00535587|O2|Outcome|Placebo Pill/Attention Control|
432835|NCT00535587|O1|Outcome|Mestinon/Exercise|
432836|NCT00535587|E4|Reported Event|Placebo Pill and Attention Control|
432837|NCT00535587|E3|Reported Event|Placebo Pill and Exercise|
432838|NCT00535587|E2|Reported Event|Mestinon and Attention Control|
432839|NCT00535587|E1|Reported Event|Mestinon & Exercise|
432840|NCT00535496|B3|Baseline|Total|Total of all reporting groups
432841|NCT00535496|B2|Baseline|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432842|NCT00535496|B1|Baseline|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432843|NCT00535496|P4|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
432844|NCT00535496|P3|Participant Flow|Sugammadex 4.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the dominant forearm and the PNS was on the non-dominant forearm.
432845|NCT00535496|P2|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Non-dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The TOF-Watch® SX was on the non-dominant forearm and the PNS was on the dominant forearm.
432846|NCT00535496|P1|Participant Flow|Sugammadex 1.0 mg/kg, TOF-Watch® SX Dominant Arm|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight. The Train of Four (TOF)-Watch® SX was on the dominant forearm and the peripheral nerve stimulator (PNS) was on the non-dominant forearm.
432847|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432848|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432849|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432850|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432851|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432852|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432853|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432854|NCT00535496|O2|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432855|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432856|NCT00535496|O1|Outcome|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432857|NCT00535496|O1|Outcome|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432858|NCT00535496|E2|Reported Event|Sugammadex 4.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 4.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
433127|NCT00534833|B3|Baseline|Total|Total of all reporting groups
432859|NCT00535496|E1|Reported Event|Sugammadex 1.0 mg/kg|Participants received an intubating dose of 0.6 mg/kg rocuronium, followed by one or more maintenance doses of 0.15 mg/kg rocuronium, if necessary. Fifteen minutes after the last dose of rocuronium, 1.0 mg/kg sugammadex was administered by intravenous (IV) bolus dose based on actual body weight.
432860|NCT00535405|B6|Baseline|Total|Total of all reporting groups
432861|NCT00535405|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432862|NCT00535405|B4|Baseline|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432863|NCT00535405|B3|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432864|NCT00535405|B2|Baseline|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432865|NCT00535405|B1|Baseline|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432866|NCT00535405|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432867|NCT00535405|P4|Participant Flow|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432868|NCT00535405|P3|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432869|NCT00535405|P2|Participant Flow|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432870|NCT00535405|P1|Participant Flow|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432871|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432872|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432873|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432874|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432875|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432876|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432877|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432878|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432879|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432880|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432881|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432882|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432883|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432884|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432885|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432886|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432887|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432888|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432889|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432890|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432891|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432892|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432893|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432894|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432895|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432896|NCT00535405|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432897|NCT00535405|O4|Outcome|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432898|NCT00535405|O3|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432899|NCT00535405|O2|Outcome|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432900|NCT00535405|O1|Outcome|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432901|NCT00535405|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily for 12 weeks
432902|NCT00535405|E4|Reported Event|Ezetimibe 10 mg/Simvastatin 40 mg|Ezetimibe 10 mg/simvastatin 40 mg once daily for 12 weeks
432903|NCT00535405|E3|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg once daily for 12 weeks
432904|NCT00535405|E2|Reported Event|Ezetimibe 10 mg/Simvastatin 20 mg|Ezetimibe (EZ) 10 mg/simvastatin (Simva) 20 mg once daily for 12 weeks
432905|NCT00535405|E1|Reported Event|Atorvastatin 10 mg|Atorvastatin (Atorva) 10 mg once daily for 12 weeks
432906|NCT00535392|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432907|NCT00535392|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432951|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432952|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
434956|NCT00530764|B5|Baseline|Total|Total of all reporting groups
432908|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432909|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432910|NCT00535392|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432911|NCT00535392|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose.~Dosage for subjects not on levetiracetam at study entry was based on weight: if <50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily)."
432912|NCT00535301|B3|Baseline|Total|Total of all reporting groups
432913|NCT00535301|B2|Baseline|Perigee|Anterior vaginal prolapse repair with graft
432914|NCT00535301|B1|Baseline|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432915|NCT00535301|P2|Participant Flow|Perigee|Anterior vaginal prolapse repair with graft
432916|NCT00535301|P1|Participant Flow|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432917|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
432918|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432919|NCT00535301|O2|Outcome|Perigee (Grafted Repair)|Anterior vaginal prolapse repair with graft
432920|NCT00535301|O1|Outcome|Anterior Colporrhaphy (Sutured Repair)|Sutured anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432921|NCT00535301|O2|Outcome|Perigee|Anterior vaginal prolapse repair with graft
432922|NCT00535301|O1|Outcome|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432923|NCT00535301|E2|Reported Event|Perigee|Anterior vaginal prolapse repair with graft
432924|NCT00535301|E1|Reported Event|Anterior Colporrhaphy|Anterior vaginal prolapse repair with anterior colporrhaphy (no graft)
432925|NCT00535288|B6|Baseline|Total|Total of all reporting groups
432926|NCT00535288|B5|Baseline|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432927|NCT00535288|B4|Baseline|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432928|NCT00535288|B3|Baseline|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432929|NCT00535288|B2|Baseline|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432930|NCT00535288|B1|Baseline|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432931|NCT00535288|P5|Participant Flow|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432932|NCT00535288|P4|Participant Flow|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432933|NCT00535288|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432934|NCT00535288|P2|Participant Flow|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432935|NCT00535288|P1|Participant Flow|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
432936|NCT00535288|O5|Outcome|Esmirtazapine 18mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432937|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
432938|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432939|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432940|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432941|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432942|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally, QD for up to 12 weeks
432943|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432944|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432945|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
432946|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
432947|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432948|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432949|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432950|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432953|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432954|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432955|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432956|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432957|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432958|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432959|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432960|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432961|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432962|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432963|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432964|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432965|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432966|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432967|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432968|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432969|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432970|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432971|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432972|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432973|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432974|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432975|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432976|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432977|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432978|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432979|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432980|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432981|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432982|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432983|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432984|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432985|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432986|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432987|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432988|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432989|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432990|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
432991|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432992|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432993|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432994|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
432995|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily QD for up to 12 weeks.
432996|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
432997|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
432998|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
432999|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
433000|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, QD for up to 12 weeks.
433811|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433001|NCT00535288|O5|Outcome|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally, QD for up to 12 weeks
433002|NCT00535288|O4|Outcome|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
433003|NCT00535288|O3|Outcome|Esmirtazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
433004|NCT00535288|O2|Outcome|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
433005|NCT00535288|O1|Outcome|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
433006|NCT00535288|E5|Reported Event|Esmirtazapine 18 mg|Participants receive esmirtazapine, 18 mg, encapsulated tablets, orally QD for up to 12 weeks.
433007|NCT00535288|E4|Reported Event|Esmirtazapine 9 mg|Participants receive esmirtazapine, 9 mg, encapsulated tablets, orally QD for up to 12 weeks.
433008|NCT00535288|E3|Reported Event|Esmertazapine 4.5 mg|Participants receive esmirtazapine, 4.5 mg, encapsulated tablets, orally QD for up to 12 weeks.
433009|NCT00535288|E2|Reported Event|Esmirtazapine 2.25 mg|Participants receive esmirtazapine, 2.25 mg, encapsulated tablets, orally QD for up to 12 weeks.
433010|NCT00535288|E1|Reported Event|Placebo|Participants receive encapsulated tablets, orally, once daily (QD) for up to 12 weeks.
433011|NCT00535262|B1|Baseline|Open EmSam|8-week open-label treatment with EmSam
433012|NCT00535262|P1|Participant Flow|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
433013|NCT00535262|O1|Outcome|EmSam|"EmSam was administered in open-label fashion during phase I of the study during which symptoms of depression were assessed weekly. The study was terminated early so the data are not reported.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
433014|NCT00535262|E1|Reported Event|EmSam|"EmSam will be administered in open-label fashion for 8-weeks during phase I of the study during which symptoms of depression will be assessed weekly. Those whose depression responds after 8-weeks will be entered into an 8-month open-label continuation phase during which they will be maintained on EmSam and be assessed on a monthly basis.~EmSam : Selegiline Transdermal System (STS); monoamine oxidase inhibitor patch"
433015|NCT00535223|B3|Baseline|Total|Total of all reporting groups
433016|NCT00535223|B2|Baseline|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
433017|NCT00535223|B1|Baseline|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
433018|NCT00535223|P2|Participant Flow|Present Centered Group Therapy|"Present Centered Group Therapy: Present Centered Group Therapy includes psych-education about PTSD and a problem solving here and now focus."
433019|NCT00535223|P1|Participant Flow|Group Based Exposure Therapy|Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking.
433020|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
433021|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
433022|NCT00535223|O2|Outcome|Present Centered Group Therapy|The group met twice a week for 16 weeks for 90 minutes per session. The focus was on dealing with problem solving in the here and now while avoiding traumatic material.
433023|NCT00535223|O1|Outcome|Group Based Exposure Therapy|"See below~Group Based Exposure Therapy: GBET is a 16-week program during which patients attend group therapy twice a week for three hours of group per day and are required to make two war trauma presentations to their group. These are recorded and the patients are required to listen to these recordings a minimum of 10 times. There are generally 10 patients per group and through the combination of making their own presentations, listening to recordings of these presentations, and hearing the presentations of the other nine group members, there are over 60 hours of exposure. Patients also learn about PTSD symptoms, sleep hygiene, specific stress/anger management techniques, and ways to cognitively restructure trauma-related thinking."
433024|NCT00535223|E2|Reported Event|Present Centered Group Therapy|Present Centered Group Therapy. No serious adverse events occurred in response to this treatment.
433025|NCT00535223|E1|Reported Event|Group Based Exposure Therapy|Group Based Exposure Therapy. No serious adverse events occurred in response to this treatment.
433812|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433026|NCT00535145|B1|Baseline|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
433027|NCT00535145|P1|Participant Flow|Study Treatment|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone)
433028|NCT00535145|O2|Outcome|Paliperidone ER Phase|Day 28 through Day 62 (1 week cross titration plus 4 weeks mono-therapy).
433029|NCT00535145|O1|Outcome|TAU Phase|Day 1 through Day 27 (4 weeks)
433030|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
433031|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
433032|NCT00535145|O1|Outcome|Study Treatment|Day 1 through Day 27: Antipsychotic treatment as usual (TAU); Day 28 through Day 62: Paliperidone ER (1 week cross titration plus 4 weeks mono-therapy).
433033|NCT00535145|E3|Reported Event|TAU - All Enrolled Participants|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks. Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
433034|NCT00535145|E2|Reported Event|Paliperidone ER Phase|Phase 2; Day 28 through Day 62: The dose of TAU was then tapered (reduced and stopped) over a 1-week period and treatment started with paliperidone extended-release (ER) tablets, 6 mg, orally (by mouth) once daily followed by 4 weeks of paliperidone ER, 3-12 mg once daily as monotherapy (treatment with Paliperidone ER alone).
433035|NCT00535145|E1|Reported Event|TAU - Pali ER|Phase 1; Day 1 through Day 27: Patients took therapy for schizophrenia as prescribed before study entry (referred to “treatment as usual” abbreviated as “TAU”) for 4 weeks who went on to participate in Phase 2 (Paliperidone ER Phase).
433036|NCT00535132|B3|Baseline|Total|Total of all reporting groups
433037|NCT00535132|B2|Baseline|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were then to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433038|NCT00535132|B1|Baseline|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433039|NCT00535132|P2|Participant Flow|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433040|NCT00535132|P1|Participant Flow|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433041|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433042|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433043|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433044|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433045|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433046|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433047|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433048|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433049|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433050|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433051|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433052|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433813|NCT00532779|O3|Outcome|Placebo|Placebo
433053|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433054|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433055|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433056|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433057|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433058|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433059|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433060|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433061|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433062|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433063|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433064|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433065|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433066|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433067|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433068|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433069|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433070|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433071|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433072|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433073|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433074|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433075|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433076|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433077|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433078|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433079|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433080|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433081|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433082|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433083|NCT00535132|O3|Outcome|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433084|NCT00535132|O2|Outcome|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433085|NCT00535132|O1|Outcome|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433086|NCT00535132|E3|Reported Event|Overall|Combined subjects in the paliperidone ER Immediate Initiation and paliperidone ER Delayed Initiation groups.
433087|NCT00535132|E2|Reported Event|PALI ER Delayed Initiation|Subjects randomly assigned to a delayed initiation were to receive blinded resperidone at their baseline dose of 4 or 6 mg for 2 weeks and were to be initiated on blinded paliperidone ER at Day 14 for 4 weeks (Delayed Initiation group).
433088|NCT00535132|E1|Reported Event|PALI ER Immediate Initiation|Subjects randomly assigned at the baseline visit to an immediate initiation of paliperidone ER from oral risperidone were to receive blinded paliperidone ER for a total of 6 weeks (Immediate Initiation group).
433089|NCT00534976|B3|Baseline|Total|Total of all reporting groups
433090|NCT00534976|B2|Baseline|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
433091|NCT00534976|B1|Baseline|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
433092|NCT00534976|P2|Participant Flow|Placebo/ Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one placebo 4-mg chewable tablet (single dose). Period III was the crossover to one Montelukast 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one placebo 5-mg chewable tablet (single dose) in Period II, crossing over to one Montelukast 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
433093|NCT00534976|P1|Participant Flow|Montelukast/ Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. In Period II, participants 4-5 years of age were randomized to receive one Montelukast 4-mg chewable tablet (single dose). Period III was the crossover to one matching placebo 4-mg chewable tablet (single dose) after a 3- to 7-day washout period. No participants 4-5 years of age were randomized, so the 4-mg doses were not dispensed. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II, crossing over to one matching placebo 5-mg chewable tablet (single dose) in Period III after a 3- to 7-day washout period.
433094|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433095|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433096|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433097|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433098|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433099|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433100|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433125|NCT00534937|E2|Reported Event|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433101|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433102|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433103|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433104|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433105|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433106|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433107|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433108|NCT00534976|O2|Outcome|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433109|NCT00534976|O1|Outcome|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433110|NCT00534976|E2|Reported Event|Placebo|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one matching placebo 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433111|NCT00534976|E1|Reported Event|Montelukast|In Period I (screening period/ placebo run-in) participants received a single-blind dose of matching-image placebo. Participants 6-14 years of age were randomized to receive one Montelukast 5-mg chewable tablet (single dose) in Period II or Period III, according to the randomized treatment sequence assigned. Period II and Period III were separated by a washout period of 3-7 days.
433112|NCT00534937|B3|Baseline|Total|Total of all reporting groups
433113|NCT00534937|B2|Baseline|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433114|NCT00534937|B1|Baseline|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
433115|NCT00534937|P2|Participant Flow|Flexitouch|Patients in this arm will receive once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433116|NCT00534937|P1|Participant Flow|Standard Compression|Patients in this arm will receive current standard of care (once-weekly short-stretch compression wrapping).
433117|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433118|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once-weekly short-stretch compression wrapping).
433119|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433120|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
433121|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433122|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
433123|NCT00534937|O2|Outcome|Flexitouch|Patients in this arm received once-a-week short stretch compression wrapping AND once-daily Flexitouch pump application (including Flexitouch application once-a-week in the clinic setting).
433124|NCT00534937|O1|Outcome|Standard Compression|Patients in this arm received current standard of care (once weekly short-stretch compression wrapping).
433126|NCT00534937|E1|Reported Event|Standard Compression|Patients in this arm will receive current standard of care (once weekly short-stretch compression wrapping).
433128|NCT00534833|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433129|NCT00534833|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433130|NCT00534833|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with OPV at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433131|NCT00534833|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP~T concomitantly with OPV at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP~T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433132|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433133|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433134|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433135|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433136|NCT00534833|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203
433137|NCT00534833|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL203.
433138|NCT00534833|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of Tritanrix-Hep B/ Hib™ combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433139|NCT00534833|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of DTaP-Hep B-PRP-T concomitantly with Oral Polio Vaccine (OPV) at age 15 to 18 months following a three dose primary series of DTaP-Hep B-PRP-T combined vaccine given concomitantly with OPV at 6, 10, and 14 weeks of age in the AL203 study.
433140|NCT00534794|B3|Baseline|Total|Total of all reporting groups
433141|NCT00534794|B2|Baseline|Pataday|1 drop each eye for 1 day
433142|NCT00534794|B1|Baseline|Elestat|1 drop each eye for 2 days
433143|NCT00534794|P2|Participant Flow|Pataday|1 drop each eye for 1 day
433144|NCT00534794|P1|Participant Flow|Elestat|1 drop each eye for 2 days
433145|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
433146|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
433147|NCT00534794|O2|Outcome|Pataday|1 drop each eye for 1 day
433148|NCT00534794|O1|Outcome|Elestat|1 drop each eye for 2 days
433149|NCT00534794|E2|Reported Event|Pataday|1 drop each eye for 1 day
433150|NCT00534794|E1|Reported Event|Elestat|1 drop each eye for 2 days
433151|NCT00533702|B3|Baseline|Total|Total of all reporting groups
433152|NCT00533702|B2|Baseline|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433153|NCT00533702|B1|Baseline|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433154|NCT00533702|P2|Participant Flow|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433155|NCT00533702|P1|Participant Flow|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433156|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433157|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433264|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433158|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433159|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433160|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433161|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433162|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433163|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433164|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433165|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433166|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433167|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433168|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433169|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433170|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433171|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433172|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433173|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433174|NCT00533702|O2|Outcome|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433175|NCT00533702|O1|Outcome|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433176|NCT00533702|E2|Reported Event|IMC-1121B (Ramucirumab)|IMC-1121B (ramucirumab): 10 mg/kg administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.
433177|NCT00533702|E1|Reported Event|IMC-1121B (Ramucirumab) + Dacarbazine|"IMC-1121B (ramucirumab): 10 milligrams/kilogram (mg/kg) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria.~Dacarbazine: 1000 milligrams/square meter (mg/m2) administered intravenously on Day 1 of 21-day cycle in the absence of disease progression, unacceptable toxicity, or other withdrawal criteria."
433178|NCT00534638|B3|Baseline|Total|Total of all reporting groups
433179|NCT00534638|B2|Baseline|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
435717|NCT00528957|B3|Baseline|Total|Total of all reporting groups
433180|NCT00534638|B1|Baseline|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433181|NCT00534638|P2|Participant Flow|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433182|NCT00534638|P1|Participant Flow|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433183|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433184|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433185|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433186|NCT00534638|O1|Outcome|Cervarix Pooled Group|Female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433187|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433188|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433189|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433190|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433191|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433192|NCT00534638|O1|Outcome|Cervarix Pooled Group|male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433193|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433194|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433195|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433196|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433197|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433198|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433199|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433200|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433201|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433202|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433203|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433204|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433205|NCT00534638|O2|Outcome|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433206|NCT00534638|O1|Outcome|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433207|NCT00534638|O2|Outcome|Cervarix/Engerix-B Pooled Group|Male and female subjects receiving Cervarix™/Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433208|NCT00534638|O1|Outcome|No-vaccine Group|Subjects who were enrolled but not vaccinated.
433209|NCT00534638|O3|Outcome|Engerix-B Group|All adolescents were vaccinated with Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433210|NCT00534638|O2|Outcome|Cervarix/Engerix-B B Group|90% of the female adolescents received Cervarix™ vaccine. Male adolescents and rest of the female adolescents received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433211|NCT00534638|O1|Outcome|Cervarix/Engerix-B A Group|90% of male and female adolescents received Cervarix™ vaccine. Rest of the subjects received Engerix™-B vaccine. Vaccines were administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433212|NCT00534638|E2|Reported Event|Engerix-B Pooled Group|Male and female subjects receiving Engerix™-B vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433213|NCT00534638|E1|Reported Event|Cervarix Pooled Group|Male and female subjects receiving Cervarix™ vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm according to a 0, 1, 6-month schedule.
433214|NCT00534599|B3|Baseline|Total|Total of all reporting groups
433215|NCT00534599|B2|Baseline|Placebo|Matching placebo tablets once daily
433216|NCT00534599|B1|Baseline|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433217|NCT00534599|P2|Participant Flow|Placebo|Matching placebo tablets once daily
433218|NCT00534599|P1|Participant Flow|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433219|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433220|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433221|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433222|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433223|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433224|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433225|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433226|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433227|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433228|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433229|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433230|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433231|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433232|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433233|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433234|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433235|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433236|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433237|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433238|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433239|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433240|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433241|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433242|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433243|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433244|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433245|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433246|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433247|NCT00534599|O2|Outcome|Placebo|Matching placebo tablets once daily
433248|NCT00534599|O1|Outcome|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433249|NCT00534599|E2|Reported Event|Placebo|Matching placebo tablets once daily
433250|NCT00534599|E1|Reported Event|Quetiapine XR|50 mg to 300 mg extended release tablets once daily
433251|NCT00534495|B3|Baseline|Total|Total of all reporting groups
433252|NCT00534495|B2|Baseline|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433253|NCT00534495|B1|Baseline|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433254|NCT00534495|P3|Participant Flow|Long Term Extension All Participants|All participants who benefited from rilonacept were eligible to enroll this phase and receive rilonacept 2.2mg/kg weekly
433255|NCT00534495|P2|Participant Flow|Placebo|"Placebo loading dose followed by maintenance dose for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the long term extension~Rilonacept: 2.2 mg/kg subcutaneously"
433256|NCT00534495|P1|Participant Flow|Rilonacept|Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week followed by a placebo loading dose and then rilonacept in the long term extension phase Rilonacept: 2.2 mg/kg subcutaneously
433257|NCT00534495|O3|Outcome|Long Term Extension 24 Weeks to 21 Months|
433258|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433259|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433260|NCT00534495|O3|Outcome|Week 24- All Subjects|
433261|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433262|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433263|NCT00534495|O3|Outcome|Week 24- All Subjects|
433814|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433265|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433266|NCT00534495|O3|Outcome|Week 24- All Subjects|
433267|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433268|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433269|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433270|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433271|NCT00534495|O2|Outcome|Placebo|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433272|NCT00534495|O1|Outcome|Rilonacept|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433273|NCT00534495|E5|Reported Event|Long Term Extension 24 Weeks to 21 Months|
433274|NCT00534495|E4|Reported Event|Placebo Week (4-24)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433275|NCT00534495|E3|Reported Event|Rilonacept Week (4-24)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433276|NCT00534495|E2|Reported Event|Placebo Week (0-4)|"Placebo for 4 weeks, followed by rilonacept loading dose (4.4mg/kg), followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433277|NCT00534495|E1|Reported Event|Rilonacept Week (0-4)|"Loading dose of rilonacept (4.4mg/kg) at Week 0, followed by rilonacept 2.2 mg/kg/week for the remainder of the study~Rilonacept: 2.2 mg/kg subcutaneously"
433278|NCT00534417|B1|Baseline|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433279|NCT00534417|P1|Participant Flow|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg orally (po) in the morning (AM) and 500 mg po in the evening (PM) in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433280|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433281|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433282|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433283|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433284|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433285|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433286|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433287|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433288|NCT00534417|O1|Outcome|Capecitabine and Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433445|NCT00534313|E4|Reported Event|Abatacept (Long-term Period)|Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433289|NCT00534417|E1|Reported Event|Treatment Group: Capecitabine/Fulvestrant|"Capecitabine will be given on a continuous basis at a total dose of 1500 mg, given as 1000 mg po AM and 500 mg po PM in patients of body weight < 80 kg, and at a total dose of 2000 mg given as 1000 mg po bid in patients with a body weight of ≥80 kg.~Fulvestrant will be given at 500 mg on Day 1 followed by 250 mg on Days 15 and 29, then 250 mg every 28 days."
433290|NCT00534404|B4|Baseline|Total|Total of all reporting groups
433291|NCT00534404|B3|Baseline|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433292|NCT00534404|B2|Baseline|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433293|NCT00534404|B1|Baseline|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433294|NCT00534404|P3|Participant Flow|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433295|NCT00534404|P2|Participant Flow|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433296|NCT00534404|P1|Participant Flow|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433297|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433298|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433299|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433300|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433301|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433302|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433303|NCT00534404|O3|Outcome|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433304|NCT00534404|O2|Outcome|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433358|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433305|NCT00534404|O1|Outcome|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433306|NCT00534404|E3|Reported Event|Internet|"Research participants in this arm will have free access to internet-assisted tobacco treatment (iQuit Smoking website).~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433307|NCT00534404|E2|Reported Event|Nicotine Patches and Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433308|NCT00534404|E1|Reported Event|NRT Patch, Phone Counseling, Internet|"As adjuncts to internet-assisted tobacco treatment (iQuit Smoking website), research participants in this arm will have access to free 8-week supply of nicotine patches, contingent upon participation in proactive telephone counseling. Patch therapy will begin with the 21 mg patch for 4 weeks, followed by 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks.~Nicotine patches: Participants will wear nicotine patches.~Telephone counseling: Participants receiving telephone counseling will receive five phone calls over a 2-month period to discuss their personal smoking cessation plan.~iQuit Smoking website: Participants will access the Project Quit (iQuit Smoking) website."
433309|NCT00534352|B1|Baseline|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433310|NCT00534352|P1|Participant Flow|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433311|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433312|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433313|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433488|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433314|NCT00534352|O1|Outcome|TDF/FTC +/- TMC125 +/- DRV/Rtv|"In the first part of the trial (Days 1-14), all subjects received TMC125 400 mg once daily (qd) in combination with fixed dose combinations (FDC) of tenofovir disoproxil (TDF)/emtricitabine (FTC) 300/200 mg qd(Truvada®) for 14 days (Treatment A: TMC125 + TDF/FTC ). On Day 14, 24-hour intensive TMC125 pharmacokinetic sampling took place and fasting lipids were assessed.~In the second part of the trial (Days 15-28) darunavir (DRV)/ritonavir (rtv) 800/100 mg qd was added to the regimen (Treatment B: TMC 125 + TDF/FTC + DRV/rtv). On Day 28, 24-hour intensive pharmacokinetic sampling for TMC125, DRV and ritonavir took place and fasting lipids were assessed.~In the third part of the trial (Day 29-42), TMC125 was discontinued and subjects received treatment with DRV/rtv 800/100 mg q.d. and TDF/FTC FDC 300/200 mg qd (Treatment C: DRV/rtv + TDF/FTC).On Day 42, fasting lipids were assessed.~Subjects discontinued or entered the optional open-label extension period DRV/rtv + TDF/FTC."
433315|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433316|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433317|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433318|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433319|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433320|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433321|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433322|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433323|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433324|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433325|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433326|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433327|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433328|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433329|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433330|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433331|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433332|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433333|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433334|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433335|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433336|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433337|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433338|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433339|NCT00534352|O4|Outcome|Optional Extension|DRV/rtv + TDF/FTC
433340|NCT00534352|O3|Outcome|Treatment C|DRV/rtv + TDF/FTC
433341|NCT00534352|O2|Outcome|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433342|NCT00534352|O1|Outcome|Treatment A|TMC125 + TDF/FTC
433343|NCT00534352|O2|Outcome|Treatment B: TMC125 + TDF/FTC + DRV/Rtv|Treatment B: TMC125 + TDF/FTC + DRV/rtv.
433344|NCT00534352|O1|Outcome|Treatment A: TMC125 + TDF/FTC|Treatment A: TMC125 + TDF/FTC.
433345|NCT00534352|E4|Reported Event|Optional Extension|DRV/rtv + TDF/FTC
433346|NCT00534352|E3|Reported Event|Treatment C|DRV/rtv + TDF/FTC
433347|NCT00534352|E2|Reported Event|Treatment B|TMC125 + TDF/FTC + DRV/rtv
433348|NCT00534352|E1|Reported Event|Treatment A|TMC125 + TDF/FTC
433349|NCT00534313|B5|Baseline|Total|Total of all reporting groups
433350|NCT00534313|B4|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
433351|NCT00534313|B3|Baseline|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433352|NCT00534313|B2|Baseline|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
433353|NCT00534313|B1|Baseline|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
433354|NCT00534313|P4|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
433355|NCT00534313|P3|Participant Flow|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433356|NCT00534313|P2|Participant Flow|Abatacept 10/10|Participants were administered iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
433357|NCT00534313|P1|Participant Flow|Abatacept 30/10|Participants were administered intravenous (iv) infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight i.e. for participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000 mg.
433489|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433359|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433360|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000mg).
433361|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433362|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
433363|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433364|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433365|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg -calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433366|NCT00534313|O4|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141.
433367|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433368|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433369|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433370|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433371|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
433372|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433373|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433374|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433375|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433376|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
433377|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433378|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
433379|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg.
433380|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433381|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 169. All participants received a dose based on their screening visit weight as per by rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000mg).
433382|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433383|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
433384|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose based on their screening visit weight.
433385|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433386|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433387|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433388|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433389|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
433390|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
433391|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
433392|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433393|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433412|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433598|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433394|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433395|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141.
433396|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433397|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433398|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433399|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433400|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433401|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433402|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433403|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433404|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433405|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433406|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433407|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433408|NCT00534313|O3|Outcome|Abatacept 3/3|Participants received iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433409|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433410|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433411|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433443|NCT00534313|O1|Outcome|All Treated Participants|Long-term period: All participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433413|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg).
433414|NCT00534313|O1|Outcome|Abatacept 30/10|Participants who received iv infusions of abatacept (30 mg/kg-calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433415|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433416|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433417|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
433418|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
433419|NCT00534313|O4|Outcome|Placebo|Participants received iv infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433420|NCT00534313|O3|Outcome|Abatacept 3/3|Participants were administered iv infusions of abatacept (3 mg/kg - calculated dose) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433421|NCT00534313|O2|Outcome|Abatacept 10/10|Participants received iv infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15,and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg and participants weighing >100 kg received 1000 mg).
433422|NCT00534313|O1|Outcome|Abatacept 30/10|Participants received iv infusions of abatacept (30 mg/kg - calculated dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Day 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing >100 kg received 1000 mg.
433423|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433424|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433425|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433426|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433427|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433428|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433444|NCT00534313|E5|Reported Event|Placebo (Short-term Period)|Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141.
433429|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433430|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received intravenous (IV) infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433431|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433432|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433433|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433434|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433435|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433436|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433437|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433438|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433439|NCT00534313|O4|Outcome|Placebo|Short-term period: Participants received IV infusions of either dextrose 5% solution or 0.9% sodium chloride solution at a constant rate over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433440|NCT00534313|O3|Outcome|Abatacept 3/3|Short-term period: Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433441|NCT00534313|O2|Outcome|Abatacept 10/10|Short-term period: Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg). Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433442|NCT00534313|O1|Outcome|Abatacept 30/10|Short-term period: Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg. Long-term period: Participants received an open-label abatacept weight-tiered dose of 10 mg/kg at Day 169 and every 28 days.
433815|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433446|NCT00534313|E3|Reported Event|Abatacept 30/10 (Short-term Period)|Participants received IV infusions of abatacept (30 mg/kg, calculated-dose) over approximately 30 minutes on Days 1 and 15, followed by 10 mg/kg (fixed-dose) abatacept infusion on Day 29 and every 28 days thereafter up to and including Day 141. All participants received a calculated dose on Days 1 and 15 followed by fixed dose based on their screening visit weight (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg.
433447|NCT00534313|E2|Reported Event|Abatacept 3/3 (Short-term Period)|Participants received IV infusions of abatacept (3 mg/kg, calculated-dose) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received calculated dose based on their screening visit weight.
433448|NCT00534313|E1|Reported Event|Abatacept 10/10 (Short-term Period)|Participants received IV infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. All participants received a dose based on their screening visit weight as per rheumatoid arthritis label (participants weighing <60 kg received 500 mg, 60 to 100 kg received 750 mg, and >100 kg received 1000 mg).
433449|NCT00534248|B3|Baseline|Total|Total of all reporting groups
433450|NCT00534248|B2|Baseline|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433451|NCT00534248|B1|Baseline|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433452|NCT00534248|P2|Participant Flow|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433453|NCT00534248|P1|Participant Flow|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433454|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433455|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433456|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433457|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433458|NCT00534248|O2|Outcome|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433459|NCT00534248|O1|Outcome|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433460|NCT00534248|E2|Reported Event|Placebo|Participants randomized to receive a single 0.65 ml subcutaneous injection of placebo.
433461|NCT00534248|E1|Reported Event|Zostavax™|Participants randomized to receive a single 0.65 ml subcutaneous injection of Zoster Vaccine, Live (Zostavax™).
433462|NCT00534209|B1|Baseline|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
433463|NCT00534209|P1|Participant Flow|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
433464|NCT00534209|O1|Outcome|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
433465|NCT00534209|E1|Reported Event|Arm I|"Patients will receive B7 vaccine once every other week for 2 courses over 12 weeks, for a maximum of 6 vaccines.~Given intradermally."
433466|NCT00534105|B3|Baseline|Total|Total of all reporting groups
433467|NCT00534105|B2|Baseline|Normal Pregnancies|Normal pregnant women without gestational diabetes
433468|NCT00534105|B1|Baseline|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433469|NCT00534105|P2|Participant Flow|Normal Pregnancies|Normal pregnant women without gestational diabetes
433470|NCT00534105|P1|Participant Flow|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433471|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
433472|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433473|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
433474|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433475|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
433476|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433477|NCT00534105|O2|Outcome|Normal Pregnancies|Normal pregnant women without gestational diabetes
433478|NCT00534105|O1|Outcome|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433479|NCT00534105|E2|Reported Event|Normal Pregnancies|Normal pregnant women without gestational diabetes
433480|NCT00534105|E1|Reported Event|Gestational Diabetics|Patients with Gestational Diabetes with a lipid screening performed during the pregnancy.
433481|NCT00534092|B3|Baseline|Total|Total of all reporting groups
433482|NCT00534092|B2|Baseline|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433483|NCT00534092|B1|Baseline|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433484|NCT00534092|P2|Participant Flow|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433485|NCT00534092|P1|Participant Flow|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433486|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433487|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433490|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433491|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433492|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433493|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433494|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433495|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433496|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433497|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433498|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433499|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433500|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433501|NCT00534092|O3|Outcome|Total|Total patients included target group and safety group.
433502|NCT00534092|O2|Outcome|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433503|NCT00534092|O1|Outcome|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433504|NCT00534092|E3|Reported Event|Total|Total patients included target group and safety group.
433505|NCT00534092|E2|Reported Event|Safety|Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ.
433506|NCT00534092|E1|Reported Event|Target|Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score >2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ).
433507|NCT00533897|B4|Baseline|Total|Total of all reporting groups
433508|NCT00533897|B3|Baseline|Placebo Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to Placebo (Day 85-169).
433509|NCT00533897|B2|Baseline|Abatacept Received in Period 2|Participants received ABA IV loading dose and SC injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 responders continued into Period 2 and were randomized to ABA (Day 85-169).
433510|NCT00533897|B1|Baseline|Period 1 Non-Responders|Participants received abatacept (ABA) intravenous (IV) loading dose and subcutaneous (SC) injections (fixed dose of 125 mg abatacept) on Day 1 followed by weekly SC injections of ABA up to Day 85 during the Lead-in Period (Period 1). Period 1 non-responders skipped Periods 2 and 3 and entered the long term extension (LTE).
433511|NCT00533897|P8|Participant Flow|Long Term Extension (LTE) Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433512|NCT00533897|P7|Participant Flow|Long Term Extension Abatacept for LI Period Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve Disease Activity Score 28 (DAS28-CRP) decrease by ≥ 0.6 from Day 1), they directly entered the Long Term Extension (LTE) receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433513|NCT00533897|P6|Participant Flow|PLA Switched to ABA With PLA IV Loading Dose in RI Period|After receiving ABA in the Lead-In, and PLA in the DBW Period, participants were randomized to receive a single Placebo IV loading dose on Day 169 followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
433514|NCT00533897|P5|Participant Flow|PLA Switched to ABA With ABA IV Loading Dose in RI Period|After receiving ABA in LI period, and PLA in the DBW Period, participants were randomized to receive a single weight-titered ABA IV loading dose (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) followed by weekly open-label SC ABA injections (fixed dose of 125 mg) in the RI Period.
433515|NCT00533897|P4|Participant Flow|ABA With IV PLA Loading Dose in Re-introduction (RI) Period|After receiving ABA in LI Period, and ABA in DBW Period, participants received a single blinded placebo IV dose on Day 169 and continued with weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg) in the RI Period.
433516|NCT00533897|P3|Participant Flow|Placebo (PLA) Double Blind Withdrawal (DBW)|After receiving ABA in the LI Period, participants received double blind Placebo SC injections starting on Day 85 and weekly for 12 weeks.
433517|NCT00533897|P2|Participant Flow|Abatacept (ABA) Double-blind Withdrawal (DBW)|After receiving ABA in the LI, participants received double blind ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433599|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433518|NCT00533897|P1|Participant Flow|Abatacept (ABA) [Lead-In (LI)]|On Day 1 of the 12 week Lead-In (LI), participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433519|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433520|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433521|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433522|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433523|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433524|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433525|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433526|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433527|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433528|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433529|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433600|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433530|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433531|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433532|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433533|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433534|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433535|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433536|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433537|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, could enter the LTE on Day 253 and receive weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433538|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433539|NCT00533897|O1|Outcome|LTE Abatacept for All Participants|This group includes all participants who received at least one dose of 125 mg SC Abatacept during the LTE and includes both the LI Period 1 non-responder and the ST Completer cohorts.
433540|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433541|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433637|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433816|NCT00532779|O3|Outcome|Placebo|Placebo
433542|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433543|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433544|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433545|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433546|NCT00533897|O2|Outcome|LTE Abatacept for Short Term Completers|Participant’s who successfully completed the Short Term of the study, entered the LTE on Day 253 and received weekly open-label SC abatacept (125 mg) in the LTE until SC administration of ABA was approved by the respective country and commercially available or until the sponsor elected to terminate the study. Participants who completed the ST study (Completers) had received ABA during LI Period 1, entered DBW Period 2 (ABA or PLA), and in RI Period 3 continued/switched to ABA (with either ABA or PLA IV loading dose, as appropriate).
433547|NCT00533897|O1|Outcome|LTE Abatacept for LI Period 1 Non-responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 and weekly for 12 weeks (ie, participants did not enter DBW or RI periods). If clinical response was achieved, participant continued in LTE until SC administration of Abatacept was approved by the respective country and commercially available or until sponsor elected to terminate the study.
433548|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433549|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433550|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433551|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433552|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433553|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433554|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433555|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433556|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433557|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433558|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433559|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433560|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433561|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433562|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433563|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433564|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433565|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433566|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433567|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433568|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433569|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433570|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433571|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433572|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433573|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433574|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433575|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433576|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433577|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433578|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433579|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433580|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433581|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433582|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433583|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433584|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433585|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433586|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433587|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433588|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433589|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433590|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433591|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433592|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433593|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433594|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433595|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433596|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433597|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433601|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433602|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433603|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433604|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433605|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433606|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433607|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433608|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433609|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433610|NCT00533897|O3|Outcome|PLA Switched to ABA With PLA IV Loading Dose [RI]|Participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433611|NCT00533897|O2|Outcome|PLA Switched to ABA With ABA IV Loading Dose [RI]|Participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced.
433612|NCT00533897|O1|Outcome|ABA With IV PLA Loading Dose [RI]|Participants received a single placebo IV dose on Day 169, and continued weekly SC injections of open-label ABA for 12 weeks (fixed dose of 125 mg).
433613|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433614|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433615|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433616|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433617|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433618|NCT00533897|O1|Outcome|ABA [LI]|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433619|NCT00533897|O2|Outcome|PLA [DB]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433620|NCT00533897|O1|Outcome|ABA [DB]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433621|NCT00533897|O2|Outcome|Placebo (PLA) [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433622|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433623|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433624|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433625|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433626|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433627|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433628|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433629|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433630|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433631|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433632|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433633|NCT00533897|O2|Outcome|PLA [DBW]|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433634|NCT00533897|O1|Outcome|ABA [DBW]|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433635|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433636|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433638|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433639|NCT00533897|O2|Outcome|PLA in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433640|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433641|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433642|NCT00533897|O1|Outcome|ABA in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433643|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received PLA SC injections starting on Day 85 and weekly for 12 weeks.
433644|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received ABA SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks.
433645|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) ABA dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433646|NCT00533897|O1|Outcome|Abatacept in Lead-In Period|On Day 1, participants received a single intravenous (IV) Abatacept (ABA) dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g). Following, participants received weekly subcutaneous (SC) of open-label ABA (fixed dose of 125 mg) through Day 78.
433647|NCT00533897|O2|Outcome|PLA Switched to ABA With PLA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single PLA IV loading dose and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
433648|NCT00533897|O1|Outcome|PLA Switched to ABA With ABA IV Loading Dose in RI Period|On Day 169, participants were randomized to receive a single ABA IV loading dose based on participant weight (<60 kg=500 mg, 60-100 kg=750 mg, >100 kg=1 g) and weekly open-label SC ABA injections (fixed dose of 125 mg) were re-introduced in the RI Period.
433649|NCT00533897|O2|Outcome|Placebo in DBW Period|Participants received placebo (PLA) SC injections starting on Day 85 and weekly for 12 weeks.
433650|NCT00533897|O1|Outcome|Abatacept in DBW Period|Participants received Abatacept (ABA) SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks
433651|NCT00533897|E4|Reported Event|Placebo Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Placebo SC injections starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were administered during Reintroduction Period 3 and during the LTE Period until completion of the LTE.
433652|NCT00533897|E3|Reported Event|Abatacept Received in Period 2|Participants who responded to abatacept in Period 1, entered Period 2 and were randomized to receive Abatacept SC injections (fixed dose of 125 mg) starting on Day 85 and weekly for 12 weeks. Abatacept SC injections of 125 mg were continued in Reintroduction Period 3 and during the LTE Period until completion of the LTE.
433653|NCT00533897|E2|Reported Event|Period 1 Non-Responders|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. If after 12 weeks the participant was a non-responder (unable to achieve DAS28-CRP decrease by ≥ 0.6 from Day 1), they directly entered the LTE receiving open label Abatacept SC injections (125 mg) starting on Day 85 until completion of the LTE.
433654|NCT00533897|E1|Reported Event|Period 1 Non-Completers|Participants received Abatacept SC injections (fixed dose of 125 mg) during Lead-in (LI) Period 1 for 12 weeks. These participants did not complete the Period and did not continue in the study.
433655|NCT00533546|B1|Baseline|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433656|NCT00533546|P1|Participant Flow|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433657|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433658|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433659|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C: Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433660|NCT00533546|O1|Outcome|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433661|NCT00533546|E1|Reported Event|Intravenous APC 10 Microgram/kg Dose|"Participants will receive APC by intravenous injection, receiving 50% of dose as a bolus and the remainder as an infusion over one hour.~Activated Protein C : Intravenous APC (10, 15, 22, 33, 50, and 75 mcg/kg) administered to patients with acute ischemic stroke within 0 - 9 hours of symptom onset"
433662|NCT00533507|B1|Baseline|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433663|NCT00533507|P1|Participant Flow|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433664|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433665|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433666|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433667|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433668|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433669|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433670|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433671|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433672|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433673|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433674|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433675|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433676|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433677|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433678|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433679|NCT00533507|O1|Outcome|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433680|NCT00533507|E1|Reported Event|Synflorix Group|Subjects receiving Synflorix co-administered with Infanrix™ hexa at 1.5, 3 and 6 months of age, and co-administered with Rotarix™ at 1.5 and 3 months of age.
433681|NCT00533351|B3|Baseline|Total|Total of all reporting groups
433682|NCT00533351|B2|Baseline|Placebo Followed by AGN201781|
433683|NCT00533351|B1|Baseline|AGN201781 Followed by Placebo|
433684|NCT00533351|P2|Participant Flow|Placebo Followed by AGN201781|
433685|NCT00533351|P1|Participant Flow|AGN201781 Followed by Placebo|
433686|NCT00533351|O2|Outcome|Placebo|
433687|NCT00533351|O1|Outcome|AGN201781|
433688|NCT00533351|O2|Outcome|Placebo|
433689|NCT00533351|O1|Outcome|AGN201781|
433690|NCT00533351|E2|Reported Event|Placebo Followed by AGN201781|
433691|NCT00533351|E1|Reported Event|AGN201781 Followed by Placebo|
433692|NCT00533273|B3|Baseline|Total|Total of all reporting groups
433693|NCT00533273|B2|Baseline|Placebo|Placebo (Sucrose and Tris)
433694|NCT00533273|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
433695|NCT00533273|P2|Participant Flow|Placebo|Placebo for injection was comprised of sucrose and Tris
433696|NCT00533273|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
433697|NCT00533273|O2|Outcome|Placebo|Placebo injection is comprised of sucrose and Tris
433698|NCT00533273|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
433699|NCT00533273|E2|Reported Event|Placebo|Placebo injection is comprised of sucrose and Tris
433700|NCT00533273|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
433701|NCT00532948|B4|Baseline|Total|Total of all reporting groups
433702|NCT00532948|B3|Baseline|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433703|NCT00532948|B2|Baseline|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433704|NCT00532948|B1|Baseline|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433705|NCT00532948|P3|Participant Flow|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433807|NCT00532779|O3|Outcome|Placebo|Placebo
433808|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433706|NCT00532948|P2|Participant Flow|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433707|NCT00532948|P1|Participant Flow|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy.
433708|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433709|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433710|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433711|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433712|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433713|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433714|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433715|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433716|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433717|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433718|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433719|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433720|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433721|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433722|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily (ideally administered daily in two divided doses approximately 12 hours apart beginning within 24 hours of the start of radiation therapy) for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433723|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433724|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433725|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433726|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433727|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433728|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433729|NCT00532948|O3|Outcome|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433809|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433810|NCT00532779|O3|Outcome|Placebo|Placebo
433730|NCT00532948|O2|Outcome|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433731|NCT00532948|O1|Outcome|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433732|NCT00532948|O1|Outcome|Capecitabine (Overall)|Capecitabine 500, 650, and 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433733|NCT00532948|E3|Reported Event|Capecitabine 850 mg/m^2|Capecitabine 850 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433734|NCT00532948|E2|Reported Event|Capecitabine 650 mg/m^2|Capecitabine 650 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433735|NCT00532948|E1|Reported Event|Capecitabine 500 mg/m^2|Capecitabine 500 mg/m^2 was administered twice daily for 14 days, followed by 7 day rest. Treatment was administered for three cycles with radiation therapy period and 3 cycles without radiation therapy
433736|NCT00532935|B3|Baseline|Total|Total of all reporting groups
433737|NCT00532935|B2|Baseline|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433738|NCT00532935|B1|Baseline|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433739|NCT00532935|P2|Participant Flow|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433740|NCT00532935|P1|Participant Flow|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433741|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433742|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433743|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433744|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433745|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433746|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433747|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433748|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
436545|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
433749|NCT00532935|O2|Outcome|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433750|NCT00532935|O1|Outcome|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433751|NCT00532935|E2|Reported Event|Pioglitazone|The Pioglitazone group includes data from patients randomized to receive treatment with oral tablets of pioglitazone initiated at a dose of 30 mg once daily (q.d.). The dose was to have been up-titrated over 4 weeks to 45 mg q.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433752|NCT00532935|E1|Reported Event|Sitagliptin/Metformin Fixed-Dose Combination|The Sitagliptin/Metformin Fixed-Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met FDC initiated at a dose of 50/500 mg twice a day (b.i.d). The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d. Patients were discontinued if they were considered clinically inappropriate for up-titration or could not be up-titrated or maintained on the up-titrated dose.
433753|NCT00532883|B5|Baseline|Total|Total of all reporting groups
433754|NCT00532883|B4|Baseline|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
433755|NCT00532883|B3|Baseline|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433756|NCT00532883|B2|Baseline|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
433757|NCT00532883|B1|Baseline|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433758|NCT00532883|P4|Participant Flow|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
433759|NCT00532883|P3|Participant Flow|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433760|NCT00532883|P2|Participant Flow|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
433761|NCT00532883|P1|Participant Flow|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433762|NCT00532883|O4|Outcome|HU Placebo/Mg Placebo|Placebo for both hydroxyurea (20 mg/kg/day) and liquid magnesium pidolate (0.6 mEq/kg/day).
433763|NCT00532883|O3|Outcome|HU Placebo/Magnesium|HU placebo combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433764|NCT00532883|O2|Outcome|Hydroxyurea/Mg Placebo|Hydroxyurea (20 mg/kg/day) combined with liquid Mg placebo.
433765|NCT00532883|O1|Outcome|Hydroxyurea/Magnesium|Hydroxyurea (20 mg/kg/day) combined with liquid magnesium pidolate (0.6 mEq/kg/day).
433766|NCT00532883|E4|Reported Event|Placebo/Placebo|
433767|NCT00532883|E3|Reported Event|Placebo/Magnesium Pidolate|20 mg/kg/day HU + 0.6 mEq/kg/day Mg
433768|NCT00532883|E2|Reported Event|Hydroxyurea/Placebo|0.6 mEq/kg/day
433769|NCT00532883|E1|Reported Event|Hydroxyurea/Magnesium Pidolate|20 mg/kg/day
433770|NCT00532779|B4|Baseline|Total|Total of all reporting groups
433771|NCT00532779|B3|Baseline|Placebo|Placebo
433772|NCT00532779|B2|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433773|NCT00532779|B1|Baseline|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433774|NCT00532779|P3|Participant Flow|Placebo|Placebo
433775|NCT00532779|P2|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433776|NCT00532779|P1|Participant Flow|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433777|NCT00532779|O3|Outcome|Placebo|Placebo
433778|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433779|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433780|NCT00532779|O3|Outcome|Placebo|Placebo
433781|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433782|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433783|NCT00532779|O3|Outcome|Placebo|Placebo
433784|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433785|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433786|NCT00532779|O3|Outcome|Placebo|Placebo
433787|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433788|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433789|NCT00532779|O3|Outcome|Placebo|Placebo
433790|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433791|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433792|NCT00532779|O3|Outcome|Placebo|Placebo
433793|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433794|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433795|NCT00532779|O3|Outcome|Placebo|Placebo
433796|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433797|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433798|NCT00532779|O3|Outcome|Placebo|Placebo
433799|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433800|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433801|NCT00532779|O3|Outcome|Placebo|Placebo
433802|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433803|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433804|NCT00532779|O3|Outcome|Placebo|Placebo
433805|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433806|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433817|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433818|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433819|NCT00532779|O3|Outcome|Placebo|Placebo
433820|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433821|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433822|NCT00532779|O3|Outcome|Placebo|Placebo
433823|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433824|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433825|NCT00532779|O3|Outcome|Placebo|Placebo
433826|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433827|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433828|NCT00532779|O3|Outcome|Placebo|Placebo
433829|NCT00532779|O2|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433830|NCT00532779|O1|Outcome|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433831|NCT00532779|E3|Reported Event|Placebo|Placebo
433832|NCT00532779|E2|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg /day
433833|NCT00532779|E1|Reported Event|NB16|Naltrexone SR 16 mg/Bupropion SR 360 mg /day
433834|NCT00532493|B3|Baseline|Total|Total of all reporting groups
433835|NCT00532493|B2|Baseline|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433836|NCT00532493|B1|Baseline|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433837|NCT00532493|P2|Participant Flow|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433838|NCT00532493|P1|Participant Flow|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433839|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433840|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433841|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433842|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433843|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433844|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433845|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433846|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433847|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433894|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
434790|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
433848|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433849|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433850|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433851|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433852|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433853|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433854|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433855|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433856|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433857|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433858|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433859|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433860|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433861|NCT00532493|O2|Outcome|Placebo|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433862|NCT00532493|O1|Outcome|Prazosin|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433863|NCT00532493|O2|Outcome|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433895|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
438418|NCT00523237|E1|Reported Event|Raltegravir|400 mg twice daily
433864|NCT00532493|O1|Outcome|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433865|NCT00532493|E2|Reported Event|Placebo Group|"Subjects randomized to this arm will be on placebo.~placebo: sugar pill"
433866|NCT00532493|E1|Reported Event|Prazosin Group|"Subjects randomized to this arm will be on prazosin.~prazosin: Subjects will be titrated up to the optimum tolerated dose based on the Dosing Algorithm. Males and females will be titrated differently with females titrated slower and to a lower maximum daily dose. The first dose will be taken while the participant is in bed for the night to avoid orthostatic syncope, an uncommon but recognized first dose effect of prazosin or any alpha-1 antagonist if started at a high dose. As a further precaution, male subjects will be advised to sit on the toilet for urination at night during the first week of dose titration. The first dose effect is avoidable by starting treatment with a low dose (1 mg at bedtime) and then titrating the dose upward gradually."
433867|NCT00532480|B1|Baseline|Duloxetine|Duloxetine : 60 mg capsules
433868|NCT00532480|P1|Participant Flow|Duloxetine|Duloxetine 60 mg capsules orally daily open label
433869|NCT00532480|O1|Outcome|Duloxetine|Duloxetine : 60 mg capsules
433870|NCT00532480|E1|Reported Event|Duloxetine|Duloxetine : 60 mg capsules
433871|NCT00532441|B1|Baseline|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
433872|NCT00532441|P2|Participant Flow|Biliary|erlotinib and docetaxel
433873|NCT00532441|P1|Participant Flow|Hepatocellular|erlotinib and docetaxel
433874|NCT00532441|O2|Outcome|Biliary|erlotinib and docetaxel
433875|NCT00532441|O1|Outcome|Hepatocellular|erlotinib and docetaxel
433876|NCT00532441|O2|Outcome|Erlotinib and Docetaxel: Hepatocellular|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
433877|NCT00532441|O1|Outcome|Erlotinib and Docetaxel: Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
433878|NCT00532441|O2|Outcome|Hepatocellular|Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15 Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28 Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15
433879|NCT00532441|O1|Outcome|Biliary|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
433880|NCT00532441|E1|Reported Event|Erlotinib and Docetaxel|"Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15~Erlotinib: Erlotinib 150 mg p.o. daily, days 2-7, 9-14, 16-28~Docetaxel: Docetaxel 30 mg/m2 IV over 30 min weekly x 3 weeks on days 1, 8 and 15"
433881|NCT00532298|B7|Baseline|Total|Total of all reporting groups
433882|NCT00532298|B6|Baseline|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433883|NCT00532298|B5|Baseline|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433884|NCT00532298|B4|Baseline|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433885|NCT00532298|B3|Baseline|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433886|NCT00532298|B2|Baseline|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433887|NCT00532298|B1|Baseline|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433888|NCT00532298|P6|Participant Flow|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433889|NCT00532298|P5|Participant Flow|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433890|NCT00532298|P4|Participant Flow|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433891|NCT00532298|P3|Participant Flow|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433892|NCT00532298|P2|Participant Flow|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433893|NCT00532298|P1|Participant Flow|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433896|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433897|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433898|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433899|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433900|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433901|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433902|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433903|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433904|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433905|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433906|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433907|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433908|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433909|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433910|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433911|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433912|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433913|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433914|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433915|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433916|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433917|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433918|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433919|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433920|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433921|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433922|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433923|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433924|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433925|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433926|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433927|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433928|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433929|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433930|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433931|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433932|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433933|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433934|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433935|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433936|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433937|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433938|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433939|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433940|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433941|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433942|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433943|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433944|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433945|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433946|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433947|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433948|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433949|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433950|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433951|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433952|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433953|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433954|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433955|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433956|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433957|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433958|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433959|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433960|NCT00532298|O6|Outcome|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433961|NCT00532298|O5|Outcome|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433962|NCT00532298|O4|Outcome|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433963|NCT00532298|O3|Outcome|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433964|NCT00532298|O2|Outcome|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433965|NCT00532298|O1|Outcome|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433966|NCT00532298|E6|Reported Event|Fluarix 2007/2008 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
433967|NCT00532298|E5|Reported Event|GSK576389A - 2007/2008 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
433968|NCT00532298|E4|Reported Event|GSK576389A - 2007/2008 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
433969|NCT00532298|E3|Reported Event|Fluarix 2006/2007 Season Group|Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
433970|NCT00532298|E2|Reported Event|GSK576389A - 2006/2007 Season - 2 Containers Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
433971|NCT00532298|E1|Reported Event|GSK576389A- 2006/2007 Season - 1 Container Group|Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
433972|NCT00532259|B1|Baseline|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
433973|NCT00532259|P1|Participant Flow|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
433974|NCT00532259|O1|Outcome|CT-011|CT-011: IV infusion of 1.5 mg/kg of CT-011 on Day 1(60 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
433975|NCT00532259|O1|Outcome|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
433976|NCT00532259|E1|Reported Event|CT-011 Antibody|CT-011 : IV infusion of 1.5 mg/kg of CT-011 on Day 1(30 to 90 days post autologous PBSCT). Treatment was repeated every 42 days for a total of three courses with treatment visits on Days 1, 43, and 85.
433977|NCT00532155|B3|Baseline|Total|Total of all reporting groups
433978|NCT00532155|B2|Baseline|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
433979|NCT00532155|B1|Baseline|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433980|NCT00532155|P2|Participant Flow|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433981|NCT00532155|P1|Participant Flow|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433982|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433983|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433984|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433985|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433986|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
434033|NCT00531947|B1|Baseline|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
433987|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433988|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433989|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433990|NCT00532155|O2|Outcome|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433991|NCT00532155|O1|Outcome|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433992|NCT00532155|E2|Reported Event|Aflibercept/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Aflibercept immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant’s refusal.
433993|NCT00532155|E1|Reported Event|Placebo/Docetaxel|Participants with Non-Small-Cell Lung Cancer (NSCLC) were administered Placebo immediately followed by Docetaxel every three weeks until disease progression, unacceptable toxicity, or participant's refusal.
433994|NCT00532129|B1|Baseline|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
433995|NCT00532129|P1|Participant Flow|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles (28 day cycles). Participants who did not achieve complete response (CR) after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 milligrams per square meter (mg/m^2) intravenous (IV) infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 milligrams per square meter per day (mg/m^2/day) oral administration (PO) on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
433996|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
433997|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
433998|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
433999|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434000|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434001|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434002|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434003|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434219|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434004|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434005|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434006|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434007|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434008|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434009|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434010|NCT00532129|O1|Outcome|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434011|NCT00532129|E1|Reported Event|Rituximab + Chlorambucil|Participants received combination therapy of rituximab plus chlorambucil for first 6 cycles. Participants who did not achieve CR after Cycle 6 then received chlorambucil alone from Cycle 7 onwards until either they achieved a CR or for a maximum of 6 additional cycles. Rituximab: 375 mg/m^2 IV infusion on Day 1 of Cycle 1; 500 mg/m^2 on Day 1 of Cycles 2-6. Chlorambucil: 10 mg/m^2/day PO on Days 1 to 7 of Cycles 1-6; 10 mg/m^2/day PO on Days 1 to 7 of Cycles 7-12, if applicable.
434012|NCT00531960|B3|Baseline|Total|Total of all reporting groups
434013|NCT00531960|B2|Baseline|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434014|NCT00531960|B1|Baseline|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434015|NCT00531960|P2|Participant Flow|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, orally (PO), daily until disease progression, unacceptable toxicity, death, or withdrawal.
434016|NCT00531960|P1|Participant Flow|Bevacizumab Plus (+) Chemotherapy|Participants received bevacizumab 15 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 milligrams per square meter [mg/m^2], IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 milligrams per milliliter multiplied by minute [mg/mL*min] on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434017|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434034|NCT00531947|P2|Participant Flow|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434035|NCT00531947|P1|Participant Flow|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434791|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434018|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434019|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434020|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434021|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434022|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434023|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434024|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434025|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434026|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434027|NCT00531960|O2|Outcome|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434028|NCT00531960|O1|Outcome|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434029|NCT00531960|E2|Reported Event|Bevacizumab + Erlotinib|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received erlotinib 150 mg tablets, PO, daily until disease progression, unacceptable toxicity, death, or withdrawal.
434030|NCT00531960|E1|Reported Event|Bevacizumab + Chemotherapy|Participants received bevacizumab 15 mg/kg, IV, on Day 1 of Cycles 1 through 7 (21 day cycles) until disease progression, unacceptable toxicity, death, or withdrawal. Participants also received a maximum of up to 6 cycles (12-18 weeks) with EITHER a gemicitabine/cisplatin regimen (gemcitabine 1250 mg/m^2, IV, on Days 1 and 8 of up to 6 cycles of 21 days, and cisplatin 80 mg/m^2, IV, on Day 1 of up to 6 cycles of 21 days); OR a carboplatin/paclitaxel regimen (paclitaxel 200 mg/m^2, IV, followed by carboplatin 6 mg/mL*min on Day 1 of up to 6 cycles of 21 days). The chemotherapy regimen and number of cycles was up to the discretion of the investigator.
434031|NCT00531947|B3|Baseline|Total|Total of all reporting groups
434032|NCT00531947|B2|Baseline|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434220|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434036|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434037|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434038|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434039|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434040|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434041|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434042|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434043|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434044|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434045|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434046|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434047|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434048|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434049|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434050|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434051|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434052|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434053|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434054|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434055|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434056|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434057|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434058|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434059|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434060|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434061|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434062|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434063|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434064|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434065|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434066|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434067|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
438494|NCT00522457|P1|Participant Flow|Ertumaxomab|
434068|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434069|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434070|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434071|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434072|NCT00531947|O2|Outcome|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434073|NCT00531947|O1|Outcome|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434074|NCT00531947|E2|Reported Event|EMSAM|"Approved Medication for Major Depressive Disorder: EMSAM (Selegiline Transdermal System) 6mg, 9mg, or 12mg~Selegiline Transdermal System : EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434075|NCT00531947|E1|Reported Event|Placebo|"Placebo Selegiline Transdermal System 6, 9 or 12~Placebo : Matching Placebo for EMSAM 6mg, 9mg, or 12mg Flexible Dose- 1 patch/24 hours- 12 Week Study"
434076|NCT00531934|B3|Baseline|Total|Total of all reporting groups
434077|NCT00531934|B2|Baseline|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434078|NCT00531934|B1|Baseline|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434079|NCT00531934|P2|Participant Flow|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434080|NCT00531934|P1|Participant Flow|Erlotinib Plus (+) Doxycycline|Participants received erlotinib 150 milligrams per day (mg/day), tablets, orally (PO) until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434081|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434082|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434083|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434084|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434085|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434086|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434087|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434088|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434089|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434090|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434091|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434092|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434093|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434094|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434095|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434096|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434097|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434098|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434099|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434100|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434101|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434102|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434103|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434104|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434105|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434106|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434107|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434108|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434109|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434110|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434111|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434112|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434113|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434114|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434115|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434116|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434117|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434118|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434119|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434120|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434121|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434122|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434123|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434124|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434125|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434126|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434127|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434128|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434129|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434294|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434130|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434131|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434132|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434133|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434134|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434135|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434136|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434137|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434138|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434139|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434140|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434141|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434142|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434143|NCT00531934|O2|Outcome|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434144|NCT00531934|O1|Outcome|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434145|NCT00531934|E2|Reported Event|Erlotinib|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity.
434146|NCT00531934|E1|Reported Event|Erlotinib + Doxycycline|Participants received erlotinib 150 mg/day, tablets, PO until progression or unacceptable toxicity and doxycycline 100 mg/day, tablets, PO for the first 4 months of the study; after this period it was the investigator's choice to continue treatment with doxycycline.
434147|NCT00531843|B3|Baseline|Total|Total of all reporting groups
434148|NCT00531843|B2|Baseline|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
434149|NCT00531843|B1|Baseline|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434150|NCT00531843|P2|Participant Flow|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary inferior vena cava (IVC) filter (prn as determined by caregiver).
434151|NCT00531843|P1|Participant Flow|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg via subcutaneous administration (SubQ) daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434152|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
434153|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434154|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
434155|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434156|NCT00531843|O2|Outcome|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
434157|NCT00531843|O1|Outcome|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434295|NCT00531661|E2|Reported Event|Control|CONTROL group: standard of care HF management
438495|NCT00522457|O1|Outcome|Ertumaxomab|
434158|NCT00531843|E2|Reported Event|No Fondaparinux|Patients at high risk or very high risk for venous thromboembolism AND contraindication to anticoagulant administration received mechanical compression, with (very high risk) or without (high risk) possible temporary IVC filter (prn as determined by caregiver).
434159|NCT00531843|E1|Reported Event|Fondaparinux Sodium|Patients at high risk or very high risk for venous thromboembolism received fondaparinux 2.5mg SubQ daily, with (very high risk) or without (high risk) mechanical compression upon admission or by 3rd day after injury.
434160|NCT00531817|B3|Baseline|Total|Total of all reporting groups
434161|NCT00531817|B2|Baseline|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434162|NCT00531817|B1|Baseline|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434163|NCT00531817|P2|Participant Flow|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434164|NCT00531817|P1|Participant Flow|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434165|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434166|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434167|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434168|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434169|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434170|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434171|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434172|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434173|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434174|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434175|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434176|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434177|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434178|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434179|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434180|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434181|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434182|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434183|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434184|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434185|NCT00531817|O2|Outcome|Placebo + DMARDs|Placebo IV over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434186|NCT00531817|O1|Outcome|Tocilizumab 8 mg/kg + DMARDs|Tocilizumab intravenously at a dose of 8 mg/kg over a 1-hour infusion, every 4 weeks, for a total of 6 infusions.
434187|NCT00531817|E3|Reported Event|Placebo + DMARDs|Initially treated with placebo + DMARDs and received ≥ 1 dose of placebo. The placebo + DMARDs group includes all data collected while patients were on placebo for those who were initially treated with placebo in the double-blind treatment period.
434188|NCT00531817|E2|Reported Event|Placebo/Tocilizumab + DMARDs|Initially treated with placebo + DMARDs then received ≥ 1 dose of tocilizumab. The placebo/tocilizumab + DMARDs group includes all data collected after patients’ first infusion of tocilizumab (whether escape therapy or extended treatment) for those who were initially treated with placebo in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
434189|NCT00531817|E1|Reported Event|Tocilizumab + DMARDs|Initially treated with tocilizumab + DMARDs and received ≥ 1 dose of tocilizumab. The tocilizumab + DMARDs group includes all data (double-blind and extended treatment periods) for patients who were initially treated with tocilizumab in the double-blind treatment period. In the extended treatment period, patients received tocilizumab 8 mg/kg 1-hour IV infusion every 4 weeks (q4weeks) for up to 1 month post-commercial availability of tocilizumab in the United States.
434190|NCT00531752|B5|Baseline|Total|Total of all reporting groups
434191|NCT00531752|B4|Baseline|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434218|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434792|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434192|NCT00531752|B3|Baseline|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator's discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434193|NCT00531752|B2|Baseline|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434194|NCT00531752|B1|Baseline|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434195|NCT00531752|P4|Participant Flow|PF-03654746 (Flexible Dose) First, Then Placebo|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434196|NCT00531752|P3|Participant Flow|Placebo First, Then PF-03654746 (Flexible Dose)|Placebo matched to PF-03654746 capsule orally once daily in the first DB intervention period and then PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in the second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434197|NCT00531752|P2|Participant Flow|PF-03654746 (Low Dose) First, Then Placebo|Low dose of PF-03654746 capsule 1 mg orally once daily for 3 weeks in first DB intervention period and then placebo matched to PF-03654746 capsule orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434198|NCT00531752|P1|Participant Flow|Placebo First, Then PF-03654746 (Low Dose)|Placebo matched to PF-03654746 capsule orally once daily for 3 weeks in first double-blind (DB) intervention period and then low dose of PF-03654746 capsule 1 milligram (mg) orally once daily for 3 weeks in second DB intervention period. A washout period of at least 7 days was maintained between each treatment period.
434199|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434200|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434201|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434202|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434203|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434204|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434205|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434206|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434207|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434208|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434209|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434210|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434211|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434212|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434213|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434214|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434215|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434216|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434217|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434688|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434221|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434222|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434223|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434224|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434225|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434226|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434227|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434228|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434229|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434230|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434231|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434232|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434233|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434234|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434235|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434236|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434237|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434238|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434239|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434240|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434241|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434242|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434243|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434244|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434245|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434246|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434247|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434248|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434249|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434250|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434251|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434252|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434253|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
438496|NCT00522457|O1|Outcome|Ertumaxomab|
434254|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434255|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434256|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434257|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434258|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434259|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434260|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434261|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434262|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434263|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434264|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434265|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434266|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434267|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434268|NCT00531752|O3|Outcome|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434269|NCT00531752|O2|Outcome|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434270|NCT00531752|O1|Outcome|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434271|NCT00531752|E3|Reported Event|Placebo|Placebo matched to PF-03654746 orally once daily for 3 weeks in first or second DB intervention period.
434272|NCT00531752|E2|Reported Event|PF-03654746 (Flexible Dose)|PF-03654746 capsule 0.5 mg orally once daily in the first week, PF-03654746 capsule 1 mg orally once daily in the second week and PF-03654746 2 mg orally once daily in the third week, depending upon the investigator’s discretion and tolerability, in first or second DB intervention period.
434273|NCT00531752|E1|Reported Event|PF-03654746 (Low Dose)|PF-03654746 capsule 1 mg orally once daily for 3 weeks in first or second DB intervention period.
434274|NCT00531661|B3|Baseline|Total|Total of all reporting groups
434275|NCT00531661|B2|Baseline|Control|CONTROL group: standard of care HF management
434276|NCT00531661|B1|Baseline|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434277|NCT00531661|P2|Participant Flow|Control|CONTROL group: standard of care HF management
434278|NCT00531661|P1|Participant Flow|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434279|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
434280|NCT00531661|O1|Outcome|Full Duration Study Cohort|Safety endpoint evaluated for all patients having follow-up after the 6-month primary period.
434281|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434282|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434283|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434284|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434285|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434286|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434287|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434288|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434289|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434290|NCT00531661|O1|Outcome|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434291|NCT00531661|O1|Outcome|Entire Randomized Study Cohort|
434292|NCT00531661|O1|Outcome|Entire Study Cohort|
434293|NCT00531661|O2|Outcome|Control|CONTROL group: standard of care HF management
434296|NCT00531661|E1|Reported Event|Treatment|TREATMENT group: standard of care HF management plus HF management based upon hemodynamic information obtained from the HF Pressure Measurement System
434297|NCT00531518|B3|Baseline|Total|Total of all reporting groups
434298|NCT00531518|B2|Baseline|Experimental Intervention|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
434299|NCT00531518|B1|Baseline|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
434300|NCT00531518|P2|Participant Flow|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
434301|NCT00531518|P1|Participant Flow|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
434302|NCT00531518|O2|Outcome|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
434303|NCT00531518|O1|Outcome|Control|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
434304|NCT00531518|E2|Reported Event|Family-aided Assertive Community Treatment|"This is the experimental intervention arm for high-risk-for-psychosis participants. The intervention includes psychiatric drugs (aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine), psychoeducational multifamily group treatment and supported employment and education .~aripiprazole; fluoxetine; bupropion; sertraline; lamotrigine: Oral, daily, generally at lower than manufacturer's recommendations~Psychoeducational multifamily group treatment: Families and patients are educated on psychobiology of psychosis and trained in coping skills to avoid psychosis by reducing stress and optimizing social environment at home, school, work~Supported employment and education: Participants are provided direct assistance, guidance and ongoing support to gain employment and succeed in their educational goals."
434305|NCT00531518|E1|Reported Event|Control Group|This is the control arm. Participants will be offered only case management. Participants may seek outside treatment, without guidance from study staff.
434306|NCT00531479|B3|Baseline|Total|Total of all reporting groups
434307|NCT00531479|B2|Baseline|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434308|NCT00531479|B1|Baseline|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434309|NCT00531479|P2|Participant Flow|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434310|NCT00531479|P1|Participant Flow|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434311|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434403|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434404|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434312|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434313|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434314|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434315|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434316|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434317|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434318|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434319|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434320|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434321|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434322|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434323|NCT00531479|O2|Outcome|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434324|NCT00531479|O1|Outcome|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434325|NCT00531479|E2|Reported Event|Voriconazole / Placebo|Week 1: Voriconazole 6 mg/kg IV BID for 24 hours, followed by voriconazole 4 mg/kg IV BID plus anidulafungin placebo IV QD; Week 2: voriconazole 4 mg/kg IV BID or voriconazole 300 mg PO BID plus anidulafungin placebo IV QD through Day 14; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin placebo; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434405|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
438497|NCT00522457|O1|Outcome|Ertumaxomab|
434326|NCT00531479|E1|Reported Event|Voriconazole/Anidulafungin|Week 1: Voriconazole 6 mg/kg intravenously (IV) twice a day (bid) for 24 hours, followed by voriconazole 4 milligrams per kilogram (mg/kg) IV BID plus anidulafungin 200 mg IV on day 1, followed by 100 mg IV once a day (QD); Week 2: Voriconazole 4 mg/kg IV BID or 300 mg orally (PO) BID plus anidulafungin 100 mg IV QD; Weeks 3 and 4: voriconazole 4 mg/kg IV BID or 300 mg PO BID plus anidulafungin 100 mg IV QD or voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy; Weeks 5 and 6: voriconazole 4 mg/kg IV BID or 300 mg PO BID monotherapy.
434327|NCT00531453|B3|Baseline|Total|Total of all reporting groups
434328|NCT00531453|B2|Baseline|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
434329|NCT00531453|B1|Baseline|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
434330|NCT00531453|P2|Participant Flow|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
434331|NCT00531453|P1|Participant Flow|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
434332|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
434333|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
434334|NCT00531453|O2|Outcome|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
434335|NCT00531453|O1|Outcome|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
434336|NCT00531453|E2|Reported Event|Four Drug Regimen (VDTC)|bortezomib, dexamethasone, thalidomide, and cyclophosphamide
434337|NCT00531453|E1|Reported Event|Three Drug Regimen (VDT)|bortezomib, dexamethasone, and thalidomide
434338|NCT00531427|B3|Baseline|Total|Total of all reporting groups
434339|NCT00531427|B2|Baseline|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434340|NCT00531427|B1|Baseline|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434341|NCT00531427|P2|Participant Flow|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434342|NCT00531427|P1|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434343|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434344|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434345|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434346|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434347|NCT00531427|O2|Outcome|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434348|NCT00531427|O1|Outcome|Double-blind BTDS 10 or 20|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434349|NCT00531427|E3|Reported Event|Open-label Run-in Period|The open-label run-in period was designed with duration of time sufficient to select those subjects who both tolerated and responded to treatment with BTDS 10 or BTDS 20 (an enriched design). During this period, subjects were required to discontinue use of all nonstudy drugs used for the treatment of chronic pain and no supplemental analgesic medications were allowed. Subjects who did not tolerate BTDS 5 were discontinued from the study.
434350|NCT00531427|E2|Reported Event|Double-blind Placebo|Placebo patches to match the BTDS patches applied for 7-day wear
434351|NCT00531427|E1|Reported Event|Double-blind BTDS|Buprenorphine transdermal patches (BTDS) 10 or 20 mcg/h applied for 7-day wear
434352|NCT00531284|B18|Baseline|Total|Total of all reporting groups
434353|NCT00531284|B17|Baseline|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434354|NCT00531284|B16|Baseline|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434355|NCT00531284|B15|Baseline|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434356|NCT00531284|B14|Baseline|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434357|NCT00531284|B13|Baseline|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434358|NCT00531284|B12|Baseline|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434359|NCT00531284|B11|Baseline|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
438498|NCT00522457|E1|Reported Event|Ertumaxomab|
434360|NCT00531284|B10|Baseline|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434361|NCT00531284|B9|Baseline|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434362|NCT00531284|B8|Baseline|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434363|NCT00531284|B7|Baseline|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434364|NCT00531284|B6|Baseline|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434365|NCT00531284|B5|Baseline|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434366|NCT00531284|B4|Baseline|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434367|NCT00531284|B3|Baseline|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434368|NCT00531284|B2|Baseline|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434369|NCT00531284|B1|Baseline|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434370|NCT00531284|P17|Participant Flow|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434371|NCT00531284|P16|Participant Flow|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434372|NCT00531284|P15|Participant Flow|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434373|NCT00531284|P14|Participant Flow|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434374|NCT00531284|P13|Participant Flow|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434375|NCT00531284|P12|Participant Flow|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434376|NCT00531284|P11|Participant Flow|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434406|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434377|NCT00531284|P10|Participant Flow|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434378|NCT00531284|P9|Participant Flow|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434379|NCT00531284|P8|Participant Flow|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434380|NCT00531284|P7|Participant Flow|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434381|NCT00531284|P6|Participant Flow|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434382|NCT00531284|P5|Participant Flow|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434383|NCT00531284|P4|Participant Flow|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434384|NCT00531284|P3|Participant Flow|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434385|NCT00531284|P2|Participant Flow|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434386|NCT00531284|P1|Participant Flow|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434387|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434388|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434389|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434390|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434391|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434392|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434393|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434394|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434395|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434396|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434397|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434398|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434399|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434400|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434401|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434402|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434787|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434407|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434408|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434409|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434410|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434411|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434412|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434413|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434414|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434415|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434416|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434417|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434418|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434419|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434420|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434421|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434422|NCT00531284|O5|Outcome|MM: CFZ 20 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434423|NCT00531284|O4|Outcome|ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434424|NCT00531284|O3|Outcome|ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Day 1.
434425|NCT00531284|O2|Outcome|ST: CFZ 20 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Day 1.
434426|NCT00531284|O1|Outcome|ST: CFZ 20 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Day 1.
434427|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434428|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434429|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434430|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434431|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434432|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434433|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434434|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434435|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434436|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434437|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434438|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434439|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434440|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434441|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434442|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434443|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434444|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434445|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434446|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434447|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434448|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434449|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434450|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434451|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434544|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434452|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434453|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434454|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434455|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434456|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434457|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434458|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434459|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434460|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434461|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434462|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434463|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434464|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434465|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434466|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434467|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434468|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434545|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434469|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434470|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434471|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434472|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434473|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434474|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434475|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434476|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434477|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434478|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434479|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434480|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434481|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434482|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434483|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434484|NCT00531284|O19|Outcome|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434485|NCT00531284|O18|Outcome|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434546|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
438499|NCT00522431|B1|Baseline|Modified ITT Population|
434486|NCT00531284|O17|Outcome|P1B WM: CFZ 20/70 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434487|NCT00531284|O16|Outcome|P1B WM: CFZ 20/56 mg/m²|Participants with Waldenstrom macroglobulinemia (WM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434488|NCT00531284|O15|Outcome|P1B NHL: CFZ 20/70 mg/m²|Participants with non-Hodgkin's lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434489|NCT00531284|O14|Outcome|P1B NHL: CFZ 20/56 mg/m²|Participants with non-Hodgkin's lymphoma (NHL) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434490|NCT00531284|O13|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434491|NCT00531284|O12|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434492|NCT00531284|O11|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434493|NCT00531284|O10|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434494|NCT00531284|O9|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434495|NCT00531284|O8|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434496|NCT00531284|O7|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434497|NCT00531284|O6|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434498|NCT00531284|O5|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434499|NCT00531284|O4|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434500|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434501|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434502|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434503|NCT00531284|O1|Outcome|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment.
434504|NCT00531284|O14|Outcome|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434505|NCT00531284|O13|Outcome|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434506|NCT00531284|O12|Outcome|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434507|NCT00531284|O11|Outcome|P1b MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434508|NCT00531284|O10|Outcome|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434509|NCT00531284|O9|Outcome|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434510|NCT00531284|O8|Outcome|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434511|NCT00531284|O7|Outcome|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434512|NCT00531284|O6|Outcome|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434513|NCT00531284|O5|Outcome|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434514|NCT00531284|O4|Outcome|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434515|NCT00531284|O3|Outcome|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434516|NCT00531284|O2|Outcome|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434517|NCT00531284|O1|Outcome|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434518|NCT00531284|E17|Reported Event|P1B MM: CFZ 20/56 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434519|NCT00531284|E16|Reported Event|P1B MM: CFZ 20/45 mg/m² + Dex|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment plus dexamethasone 40 mg weekly. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434520|NCT00531284|E15|Reported Event|P1B LYM: CFZ 20/70 mg/m²|Participants with lymphoma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434547|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434788|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434521|NCT00531284|E14|Reported Event|P1B LYM: CFZ 20/56 mg/m²|Participants with lymphoma (LYM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434522|NCT00531284|E13|Reported Event|P1B MM: CFZ 20/70 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434523|NCT00531284|E12|Reported Event|P1B MM: CFZ 20/56 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434524|NCT00531284|E11|Reported Event|P1B MM: CFZ 20/45 mg/m²|Participants with multiple myeloma (MM) received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434525|NCT00531284|E10|Reported Event|P1B MM: CFZ 20/36 mg/m²|Participants with multiple myeloma received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434526|NCT00531284|E9|Reported Event|P1B ST: CFZ 20/70 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 70 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434527|NCT00531284|E8|Reported Event|P1B ST: CFZ 20/56 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 56 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434528|NCT00531284|E7|Reported Event|P1B ST: CFZ 20/45 mg/m²|Participants with solid tumors received carfilzomib 20 mg/m² administered by intravenous infusion over 30 minutes on Cycle 1 Days 1 and 2 only, then 45 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434529|NCT00531284|E6|Reported Event|P1B ST: CFZ 45 mg/m²|Participants with solid tumors received carfilzomib 45 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434530|NCT00531284|E5|Reported Event|P1B ST: CFZ 36 mg/m²|Participants with solid tumors received carfilzomib 36 mg/m² administered by intravenous infusion over 30 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle for at least 2 cycles. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434531|NCT00531284|E4|Reported Event|P2 ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434532|NCT00531284|E3|Reported Event|P1B ST: CFZ 20/36 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 36 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434533|NCT00531284|E2|Reported Event|P1B ST: CFZ 20/27 mg/m² Bolus|Participants with solid tumors received carfilzomib 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Cycle 1 Days 1 and 2 only, then 27 mg/m² on Days 8, 9, 15 and 16 and thereafter for the remainder of treatment. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434534|NCT00531284|E1|Reported Event|P1B ST: CFZ 20 mg/m² Bolus|Participants with solid tumors (ST) received carfilzomib (CFZ) 20 mg/m² administered by bolus intravenous infusion over 2-10 minutes on Days 1, 2, 8, 9, 15, and 16 of a 28-day cycle. All participants with stable disease or better after 2 cycles could continue treatment until progressive disease or unacceptable toxicity.
434535|NCT00531206|B1|Baseline|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434536|NCT00531206|P1|Participant Flow|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434537|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434538|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434539|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434540|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434541|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434542|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434543|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434548|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434549|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434550|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434551|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434552|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434553|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434554|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434555|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434556|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434557|NCT00531206|O1|Outcome|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434558|NCT00531206|E1|Reported Event|Aptivus® in Combination With Low-dose Norvir®|Aptivus® in combination with low-dose Norvir® and optimised backbone therapy
434559|NCT00531050|B7|Baseline|Total|Total of all reporting groups
434560|NCT00531050|B6|Baseline|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434561|NCT00531050|B5|Baseline|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434562|NCT00531050|B4|Baseline|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434563|NCT00531050|B3|Baseline|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434564|NCT00531050|B2|Baseline|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434573|NCT00531050|O5|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434636|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434565|NCT00531050|B1|Baseline|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434566|NCT00531050|P6|Participant Flow|Part 1: Sequence F, Part 2: Sequence F|"Part 1: Sequence 'F' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'F' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434567|NCT00531050|P5|Participant Flow|Part 1: Sequence E, Part 2: Sequence E|"Part 1: Sequence 'E' consisted of - Period 1, patient received single dose of salmeterol 50μg via Diskus DPI. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'E' consisted of - Period 1, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434568|NCT00531050|P4|Participant Flow|Part 1; Sequence D, Part 2: Sequence D|"Part 1: Sequence 'D' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'D' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434569|NCT00531050|P3|Participant Flow|Part 1: Sequence C, Part 2: Sequence C|"Part 1: Sequence 'C' consisted of - Period 1, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus DPI. Period 3, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device.~Part 2: Sequence 'C' consisted of - Period 1, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device . In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434570|NCT00531050|P2|Participant Flow|Part 1 : Sequence B, Part 2: Sequence B|"Part 1: Sequence 'B' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule administered via the Concept1 inhaler device. Period 2, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. Period 3, patient received single dose of salmeterol 50μg via Diskus DPI.~Part 2: Sequence 'B' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. Period 3, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434571|NCT00531050|P1|Participant Flow|Part 1: Sequence A, Part 2: Sequence A|"Part 1: Sequence 'A' consisted of - Period 1, patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. Period 2, patient received single dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). Period 3, patient received single dose of indacaterol matching placebo via the Concept1 inhaler device.~Part 2: Sequence 'A' consisted of - Period 1, patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. Period 2, patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus DPI. Period 3, patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. In Part 2 of the study, at 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals."
434572|NCT00531050|O6|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434635|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434574|NCT00531050|O4|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434575|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434576|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434577|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434578|NCT00531050|O3|Outcome|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434579|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434580|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434581|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434582|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434583|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434584|NCT00531050|O2|Outcome|Part 2:Salmeterol 50μg Morning/Salmeterol 50μg Evening|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434585|NCT00531050|O1|Outcome|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434586|NCT00531050|O3|Outcome|Part 1: Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434587|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434588|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434589|NCT00531050|O2|Outcome|Part 1 : Salmeterol 50μg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434590|NCT00531050|O1|Outcome|Part 1: Indacaterol 300μg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434591|NCT00531050|E6|Reported Event|Part 2:Placebo Morning/Placebo Evening|Patients received single inhalation dose of indacaterol matching placebo in morning and evening via Concept1 device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434592|NCT00531050|E5|Reported Event|Part 2:Salmeterol AM 50mcg/Salmeterol PM 50mcg|Patients received morning and evening single inhalational dose of salmeterol 50μg via Diskus dry powder inhaler (DPI). For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434593|NCT00531050|E4|Reported Event|Part 2:Indacaterol 300μg Morning/Placebo Evening|Patients received a morning single inhalational dose of indacaterol 300μg and an evening single inhalation dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am) and the evening dose between 8 and 9pm. 20 minutes following each dose, patients received three doses of nebulized salbutamol 2.5 mg at 20 minute intervals.
434594|NCT00531050|E3|Reported Event|Part 1:Placebo|Patient received single dose of indacaterol matching placebo via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434595|NCT00531050|E2|Reported Event|Part 1:Salmeterol 50mcg|Patient received single dose of salmeterol 50μg via Diskus DPI. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434596|NCT00531050|E1|Reported Event|Part 1:Indacaterol 300mcg|Patient received a single inhaled dose of indacaterol 300μg capsule via the Concept1 inhaler device. For each treatment period and for each patient, the doses were to be administered at approximately the same time in the morning (i.e. between 8 and 9am).
434597|NCT00531011|B3|Baseline|Total|Total of all reporting groups
434598|NCT00531011|B2|Baseline|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434599|NCT00531011|B1|Baseline|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434600|NCT00531011|P2|Participant Flow|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434601|NCT00531011|P1|Participant Flow|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434602|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434603|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434604|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434605|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434606|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434607|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434608|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434609|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434610|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434611|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434612|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434613|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434614|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434615|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434616|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434617|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434618|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434619|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434620|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434621|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434622|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434623|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434624|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434625|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434626|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434627|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434628|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434629|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434630|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434631|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434632|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434633|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434634|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434637|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434638|NCT00531011|O2|Outcome|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434639|NCT00531011|O1|Outcome|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434640|NCT00531011|E2|Reported Event|TAXUS® Liberté™|Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
434641|NCT00531011|E1|Reported Event|XIENCE V|Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)
434642|NCT00530946|B5|Baseline|Total|Total of all reporting groups
434643|NCT00530946|B4|Baseline|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434644|NCT00530946|B3|Baseline|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434645|NCT00530946|B2|Baseline|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434646|NCT00530946|B1|Baseline|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434647|NCT00530946|P4|Participant Flow|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434648|NCT00530946|P3|Participant Flow|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434649|NCT00530946|P2|Participant Flow|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434650|NCT00530946|P1|Participant Flow|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434651|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434652|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434653|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434654|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434655|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434656|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434657|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434658|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434659|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434660|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434661|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434662|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434663|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434664|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434665|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434666|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434667|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434668|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434669|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434670|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434671|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434672|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434673|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434674|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434675|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434676|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434677|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434678|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434679|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434680|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434681|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434682|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434683|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434684|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434685|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434686|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434687|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434689|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434690|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434691|NCT00530946|O4|Outcome|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434692|NCT00530946|O3|Outcome|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434693|NCT00530946|O2|Outcome|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434694|NCT00530946|O1|Outcome|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434695|NCT00530946|E4|Reported Event|CI-1038 5 mg/10 mg|Amlodipine 5 mg/Atorvastatin 10 mg single pill combination (CI-1038 5 mg/10 mg)
434696|NCT00530946|E3|Reported Event|CI-1038 5 mg/5 mg|Amlodipine 5 mg/Atorvastatin 5 mg single pill combination (CI-1038 5 mg/5 mg)
434697|NCT00530946|E2|Reported Event|CI-1038 2.5 mg/10 mg|Amlodipine 2.5 mg/Atorvastatin 10 mg single pill combination (CI-1038 2.5 mg/10 mg)
434698|NCT00530946|E1|Reported Event|CI-1038 2.5 mg/5 mg|Amlodipine 2.5 mg/Atorvastatin 5 mg single pill combination (CI-1038 2.5mg/5mg)
434699|NCT00530920|B4|Baseline|Total|Total of all reporting groups
434700|NCT00530920|B3|Baseline|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434701|NCT00530920|B2|Baseline|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434702|NCT00530920|B1|Baseline|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434703|NCT00530920|P3|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434704|NCT00530920|P2|Participant Flow|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given once daily
434705|NCT00530920|P1|Participant Flow|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434706|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434707|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434708|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434709|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434710|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434711|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434712|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434713|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434714|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434715|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434716|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434717|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434718|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434719|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434720|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434721|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434722|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434723|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434724|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434725|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434726|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434727|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434728|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434729|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434730|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434731|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434732|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434733|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434734|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434789|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434735|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434736|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434737|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434738|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434739|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434740|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434741|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434742|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434743|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434744|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434745|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434746|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434747|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434748|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434749|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434750|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434751|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434752|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434753|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434754|NCT00530920|O3|Outcome|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434755|NCT00530920|O2|Outcome|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434756|NCT00530920|O1|Outcome|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434757|NCT00530920|E3|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/100 mg Twice Daily|Tipranavir 500 mg boosted with ritonavir 100 mg given twice daily
434758|NCT00530920|E2|Reported Event|Tipranavir With Ritonavir (TPV/r) 250/100 mg Twice Daily|Tipranavir 250 mg boosted with ritonavir 100 mg given twice daily
434759|NCT00530920|E1|Reported Event|Tipranavir With Ritonavir (TPV/r) 500/200 mg Once Daily|Tipranavir 500 mg boosted with ritonavir 200 mg given once daily
434760|NCT00530855|B1|Baseline|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434761|NCT00530855|P1|Participant Flow|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434762|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434763|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434764|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434765|NCT00530855|O1|Outcome|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434766|NCT00530855|E1|Reported Event|Lacosamide|Lacosamide tablets for dosing 100 -800 mg/day
434767|NCT00530842|B3|Baseline|Total|Total of all reporting groups
434768|NCT00530842|B2|Baseline|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
434769|NCT00530842|B1|Baseline|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
434770|NCT00530842|P2|Participant Flow|Fluticasone + Salmeterol / Tiotropium + Salmeterol|Flu+Sal 500+50mcg b.i.d. / Tio 18mcg o.d. + Sal 50mcg b.i.d.
434771|NCT00530842|P1|Participant Flow|Tiotropium + Salmeterol / Fluticasone + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. / Flu+Sal 500+50mcg b.i.d.
434772|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434773|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434774|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434775|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434776|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434777|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434778|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434779|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434780|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434781|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434782|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434783|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434784|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434785|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434786|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
438500|NCT00522431|P1|Participant Flow|Modified ITT Population|
434793|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434794|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434795|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434796|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434797|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434798|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434799|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434800|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434801|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434802|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434803|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434804|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434805|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434806|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434807|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434808|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434809|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434810|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434811|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434812|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434813|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434814|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434815|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434816|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434817|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434818|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434819|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434820|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434821|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434822|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434823|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434824|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434825|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434826|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434827|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434828|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434829|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434830|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434831|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434832|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434833|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434834|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434835|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434836|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434837|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434838|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434839|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434840|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434841|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434842|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434843|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434844|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434845|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434846|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434847|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434848|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434849|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434850|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434851|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434852|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434853|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434854|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434855|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
438501|NCT00522431|O1|Outcome|Modified ITT Population|
434856|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434857|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434858|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434859|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434860|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434861|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434862|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434863|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434864|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434865|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434866|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434867|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434868|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434869|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434870|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434871|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434872|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434873|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434874|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434875|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434876|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434877|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434878|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434879|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434880|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434881|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434882|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434883|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434884|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434885|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434886|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434887|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434888|NCT00530842|O2|Outcome|Fluticasone + Salmeterol|Flu+Sal 500+50mcg b.i.d. in Period 1 or 2
434889|NCT00530842|O1|Outcome|Tiotropium + Salmeterol|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1 or 2
434890|NCT00530842|E4|Reported Event|Fluticasone + Salmeterol (Period 2)|Flu+Sal 500+50mcg b.i.d. in Period 2
434891|NCT00530842|E3|Reported Event|Fluticasone + Salmeterol (Period 1)|Flu+Sal 500+50mcg b.i.d. in Period 1
434892|NCT00530842|E2|Reported Event|Tiotropium + Salmeterol (Period 2)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 2
434893|NCT00530842|E1|Reported Event|Tiotropium + Salmeterol (Period 1)|Tio 18mcg o.d. + Sal 50mcg b.i.d. in Period 1
434894|NCT00530816|B4|Baseline|Total|Total of all reporting groups
434895|NCT00530816|B3|Baseline|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
434896|NCT00530816|B2|Baseline|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434897|NCT00530816|B1|Baseline|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434898|NCT00530816|P3|Participant Flow|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of subsequent cycles, for up to 12 cycles.
434899|NCT00530816|P2|Participant Flow|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434900|NCT00530816|P1|Participant Flow|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434901|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434902|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434903|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434952|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
434953|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
434904|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434905|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434906|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434907|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434908|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434909|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434910|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434911|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434912|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434913|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434914|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434915|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434916|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434917|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434918|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434919|NCT00530816|O3|Outcome|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434920|NCT00530816|O2|Outcome|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434921|NCT00530816|O1|Outcome|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434922|NCT00530816|E3|Reported Event|Part 2: Carfilzomib 20/27 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 of Cycle 1. If all doses were well-tolerated the dose was escalated to 27 mg/m² IV on Days 1, 2, 8, 9, 15, and 16 for subsequent cycles, for up to 12 cycles.
434923|NCT00530816|E2|Reported Event|Part 2: Carfilzomib 20 mg/m²|Participants not previously treated with bortezomib received carfilzomib 20 mg/m² IV injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434924|NCT00530816|E1|Reported Event|Part 1: Carfilzomib 20 mg/m²|Participants previously treated with bortezomib received carfilzomib 20 mg/m² intravenous (IV) injection on Days 1, 2, 8, 9, 15, and 16, in 28-day treatment cycles for a maximum of 12 cycles.
434925|NCT00530790|B1|Baseline|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434926|NCT00530790|P1|Participant Flow|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434927|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434954|NCT00530777|E2|Reported Event|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
434955|NCT00530777|E1|Reported Event|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
434928|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434929|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434930|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434931|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434932|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434933|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434934|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434935|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434936|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434937|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434938|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434939|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434940|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434941|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434942|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434943|NCT00530790|O1|Outcome|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434944|NCT00530790|E1|Reported Event|Ropinirole CR-RLS|Subjects who took oral Ropinirole CR-RLS once daily 1-2 hours before onset of Restless Legs Syndrome (RLS) symptoms (after 4pm). Initial dose level was 0.5 mg/day and increased weekly by 1 mg/day until sufficient efficacy was obtained without any tolerability issues. Treatment period was 12 weeks. Maximum dose level was 6 mg per day.
434945|NCT00530777|B3|Baseline|Total|Total of all reporting groups
434946|NCT00530777|B2|Baseline|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
434947|NCT00530777|B1|Baseline|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
434948|NCT00530777|P2|Participant Flow|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
434949|NCT00530777|P1|Participant Flow|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
434950|NCT00530777|O2|Outcome|Placebo|oral placebo twice daily from 34 weeks gestation to 1 year postpartum
434951|NCT00530777|O1|Outcome|Valacyclovir|500 mg oral valacyclovir twice daily from 34 weeks gestation to 1 year postpartum
434957|NCT00530764|B4|Baseline|Placebo|Range of 1-16 sprays per day of placebo spray
434958|NCT00530764|B3|Baseline|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434959|NCT00530764|B2|Baseline|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434960|NCT00530764|B1|Baseline|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434961|NCT00530764|P4|Participant Flow|Placebo|Range of 1-16 sprays per day of placebo spray
434962|NCT00530764|P3|Participant Flow|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434963|NCT00530764|P2|Participant Flow|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434964|NCT00530764|P1|Participant Flow|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434965|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434966|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434967|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434968|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434969|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434970|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434971|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434972|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434973|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434974|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434975|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434976|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434977|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434978|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434979|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434980|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434981|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434982|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434983|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434984|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434985|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434986|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434987|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434988|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434989|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434990|NCT00530764|O3|Outcome|Sativex Low Dose|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434991|NCT00530764|O2|Outcome|Sativex Medium Dose|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434992|NCT00530764|O1|Outcome|Sativex High Dose|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434993|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434994|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434995|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
434996|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
434997|NCT00530764|O4|Outcome|Placebo|Range of 1-16 sprays per day of placebo spray
434998|NCT00530764|O3|Outcome|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
434999|NCT00530764|O2|Outcome|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
435000|NCT00530764|O1|Outcome|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
435001|NCT00530764|E4|Reported Event|Placebo|Range of 1-16 sprays per day of placebo spray
435002|NCT00530764|E3|Reported Event|Sativex Low Dose Group|Range of 1 to 4 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 10.8mg THC and 10mg CBD.
435003|NCT00530764|E2|Reported Event|Sativex Medium Dose Group|Range of 6 to 10 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 27mg THC and 25mg CBD.
435004|NCT00530764|E1|Reported Event|Sativex High Dose Group|Range of 11 to 16 sprays per day. Each actuation of oromucosal spray delivers 2.7mg delta-9-tetrahydrocannabinol (THC) and 2.5mg cannabidiol (CBD). Thus maximum daily dose is 43.2mg THC and 40mg CBD.
435005|NCT00530712|B1|Baseline|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
435006|NCT00530712|P1|Participant Flow|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
435007|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435008|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435009|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435010|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435011|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435012|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435013|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435014|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435015|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435016|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435017|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex™ Peripheral Self-Expanding Stent System
435018|NCT00530712|O1|Outcome|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435019|NCT00530712|E1|Reported Event|EverFlex™ Peripheral Self-Expanding Stent System|Subjects recieved the EverFlex Peripheral Self-Expanding Stent
435020|NCT00530634|B1|Baseline|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
435021|NCT00530634|P1|Participant Flow|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
435022|NCT00530634|O1|Outcome|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
435023|NCT00530634|E1|Reported Event|Gemcitabine + Cisplatin|Surgical resection followed by (within 60 days) by chemotherapy (Gemcitabine at 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21 day cycle and Cisplatin at 75 mg/m2 IV over 1 hour on day 8 of a 21 day cycle) followed by radiation therapy (treated using linear accelerator with photon beam energy of 6-21 MV) upon completion of 3 cycles of chemotherapy.
435024|NCT00530504|B1|Baseline|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
435025|NCT00530504|P1|Participant Flow|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
435026|NCT00530504|O1|Outcome|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
435027|NCT00530504|E1|Reported Event|Intervention|PROTÉGÉ™ GPS™ and PROTÉGÉ™ RX Carotid Stent Systems and SpiderFX™ Embolic Protection Device: Carotid artery stenting with distal embolic protection.
435028|NCT00530439|B3|Baseline|Total|Total of all reporting groups
435029|NCT00530439|B2|Baseline|Control|
435030|NCT00530439|B1|Baseline|Lifestyle Intervention|physical activity, dietetic counselling
435031|NCT00530439|P2|Participant Flow|Control|
435032|NCT00530439|P1|Participant Flow|Lifestyle Intervention|physical activity, dietetic counselling
435033|NCT00530439|O2|Outcome|Control|
435034|NCT00530439|O1|Outcome|Lifestyle Intervention|physical activity, dietetic counselling
435035|NCT00530439|E2|Reported Event|Control|
435036|NCT00530439|E1|Reported Event|Lifestyle Intervention|physical activity, dietetic counselling
435037|NCT00530348|B3|Baseline|Total|Total of all reporting groups
435038|NCT00530348|B2|Baseline|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435039|NCT00530348|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435040|NCT00530348|P2|Participant Flow|Alemtuzumab|Alemtuzumab (Lemtrada™) 12 milligram (mg) per day intravenous (IV) infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435041|NCT00530348|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 microgram (mcg) subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435042|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435043|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435044|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435045|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435046|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435047|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435048|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435049|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435050|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435051|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435052|NCT00530348|O2|Outcome|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435053|NCT00530348|O1|Outcome|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435054|NCT00530348|E2|Reported Event|Alemtuzumab|Alemtuzumab 12 mg per day IV infusion on 5 consecutive days at Month 0, followed by alemtuzumab 12 mg per day IV infusion on 3 consecutive days at Month 12.
435055|NCT00530348|E1|Reported Event|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 24 months. Dose adjustment was done as per Investigator's discretion.
435056|NCT00530335|B1|Baseline|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435057|NCT00530335|P1|Participant Flow|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435058|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435059|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435060|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435061|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435062|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435063|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435064|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435092|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435065|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435066|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435067|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435068|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435069|NCT00530335|O1|Outcome|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435070|NCT00530335|E1|Reported Event|Atomoxetine|40 mg/day every, by mouth, for 1 week; 80 mg/day every day, by mouth, for 1 week; 105 mg/day every day, by mouth, for 2 weeks; 120 mg/day every day, by mouth, for 4 weeks
435071|NCT00530270|B3|Baseline|Total|Total of all reporting groups
435072|NCT00530270|B2|Baseline|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435073|NCT00530270|B1|Baseline|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435074|NCT00530270|P2|Participant Flow|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435075|NCT00530270|P1|Participant Flow|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435076|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435077|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435078|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435079|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435080|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435081|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435082|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435083|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435084|NCT00530270|O2|Outcome|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435085|NCT00530270|O1|Outcome|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435086|NCT00530270|E2|Reported Event|Placebo|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435087|NCT00530270|E1|Reported Event|Dexamethasone|0.3 mg/kg (12 mg maximum single dose) every 12 hours until discharge from the hospital or for a maximum of 4 doses, whichever comes first. Thereafter, study drug will be tapered over 6 days (not to exceed 8 days).
435088|NCT00530257|B1|Baseline|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
435089|NCT00530257|P1|Participant Flow|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed on the measures described below.
435090|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435091|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435322|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435093|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435094|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435095|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435096|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435097|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435098|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435099|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435100|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435101|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435102|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435103|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435104|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435105|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435106|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435107|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child’s performance on different domains of attention and executive functioning was assessed.
435108|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435109|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435110|NCT00530257|O2|Outcome|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435111|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435323|NCT00529542|O2|Outcome|Placebo|Placebo qd
435112|NCT00530257|O2|Outcome|Placebo|This is a crossover study. Thirty of thirty-one enrolled subjects completed the medication and placebo phases
435113|NCT00530257|O1|Outcome|Medication|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the child's performance on different domains of attention and executive functioning was assessed.
435114|NCT00530257|E2|Reported Event|Placebo|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
435115|NCT00530257|E1|Reported Event|OROS Methylphenidate|Children participated in a double blind placebo controlled crossover study comparing one week of treatment with the optimal dose of OROS methylphenidate with one week of treatment with placebo. The order of administering OROS-methylphenidate versus placebo was randomized and counterbalanced across participants. At the end of each week the parents rated medication side effects on the Stimulant Side Effect Rating Scale (described previously). Score of 7-9 on this scale were considered adverse effects.
435116|NCT00530088|B1|Baseline|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
435117|NCT00530088|P1|Participant Flow|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
435118|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
435119|NCT00530088|O1|Outcome|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
435120|NCT00530088|E1|Reported Event|Porfimer Sodium|"Patients receive porfimer sodium subcutaneously followed by photodynamic therapy (PDT) comprising laser light delivered by a single or a diffuser (i.e., for broad areas of dysplasia) fiberoptic lens fiber.~porfimer sodium: IV"
435121|NCT00530023|B3|Baseline|Total|Total of all reporting groups
435122|NCT00530023|B2|Baseline|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435123|NCT00530023|B1|Baseline|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435124|NCT00530023|P2|Participant Flow|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435125|NCT00530023|P1|Participant Flow|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435126|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435127|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435128|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435129|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435130|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435131|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435132|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435133|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435134|NCT00530023|O2|Outcome|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435135|NCT00530023|O1|Outcome|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435136|NCT00530023|E2|Reported Event|Multiple Daily Injections (MDI)|Continue with current Multiple Daily Injection therapy
435137|NCT00530023|E1|Reported Event|722 Sensor Augmented Insulin Pump|722 MiniMed Paradigm REAL-Time System
435138|NCT00529789|B1|Baseline|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435139|NCT00529789|P1|Participant Flow|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435140|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435141|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435142|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435143|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435144|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435145|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435146|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435147|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435148|NCT00529789|O5|Outcome|Duloxetine - 120 mg|120 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
435149|NCT00529789|O4|Outcome|Duloxetine Dose - 90 mg|90 milligrams (mg) every day (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
435150|NCT00529789|O3|Outcome|Duloxetine - 60 mg|60 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
435151|NCT00529789|O2|Outcome|Duloxetine Dose - 30 mg|30 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
435152|NCT00529789|O1|Outcome|Duloxetine Dose - 20 mg|20 milligrams (mg) every day, once-daily (QD), by mouth (PO); If patient is ≤40kg, initial dose is 20mg, then titrated up.
435153|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435154|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435155|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435156|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435157|NCT00529789|O1|Outcome|Duloxetine|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435158|NCT00529789|E2|Reported Event|Duloxetine - Period IV|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) between Weeks 18 - 30; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435159|NCT00529789|E1|Reported Event|Duloxetine - Period II/III|20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 18 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
435160|NCT00529763|B4|Baseline|Total|Total of all reporting groups
435161|NCT00529763|B3|Baseline|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435162|NCT00529763|B2|Baseline|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435163|NCT00529763|B1|Baseline|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435164|NCT00529763|P3|Participant Flow|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435165|NCT00529763|P2|Participant Flow|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435166|NCT00529763|P1|Participant Flow|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435167|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435168|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435169|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435170|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435171|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435172|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435173|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435324|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435174|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435175|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435176|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435177|NCT00529763|O2|Outcome|100 mg QD|Participants with CP CML treated with dasatinib 100 mg QD
435178|NCT00529763|O1|Outcome|70 mg BID|Participants with AP CML or Ph+ ALL treated with 70 mg dasatinib BID
435179|NCT00529763|O3|Outcome|Blast Phase CML/Ph+ ALL|Participants with MyBP or LyBP CML or Ph+ALL who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
435180|NCT00529763|O2|Outcome|Accelerated CML|Participants with Ph+ AP who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance.Dasatinib was administered orally at a dose of 70 mg BID in advanced phase CML or Ph+ ALL. Participants with advanced disease with BID dosing were required to take their dose in the morning and evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
435181|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with Ph+ CP CML who have received prior treatment with Imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants with chronic phase CML with QD dosing were permitted to take their dose either in the morning or evening. Subjects will be treated until progression of disease or intolerable toxicity as determined by the treating physician.
435182|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435183|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435184|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435185|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435186|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435187|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435188|NCT00529763|O3|Outcome|Total|All treated Participants with Advanced Disease CML - Accelerated Phase (AP) and Blast Phase/PH+ ALL
435189|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435190|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435191|NCT00529763|O1|Outcome|CP CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435192|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435325|NCT00529542|O2|Outcome|Placebo|Placebo qd
435326|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435327|NCT00529542|O2|Outcome|Placebo|Placebo qd
435328|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435329|NCT00529542|O2|Outcome|Placebo|Placebo qd
435193|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435194|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435195|NCT00529763|O2|Outcome|Advanced Disease CML - Blast Phase/PH+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435196|NCT00529763|O1|Outcome|Advanced Disease CML - Accelerated Phase (AP)|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435197|NCT00529763|O1|Outcome|Chronic Phase (CP) CML|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435198|NCT00529763|E3|Reported Event|Chronic Phase|Participants with chronic phase (CP) CML who have received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 100 mg QD in patients with chronic phase CML. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435199|NCT00529763|E2|Reported Event|Blast Phase / Ph+ ALL|Participants with blast phase (BP) advanced disease CML or Philadelphia positive acute lymphoblastic leukemia (Ph+ALL) who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435200|NCT00529763|E1|Reported Event|Accelerated Phase|Participants with AP advanced disease CML who received prior treatment with imatinib mesylate and can no longer be treated with this drug due to primary or acquired resistance or intolerance. Dasatinib was administered orally at a dose of 70 mg BID. Participants were treated until progression of disease or intolerable toxicity as determined by the treating physician.
435201|NCT00529659|B3|Baseline|Total|Total of all reporting groups
435202|NCT00529659|B2|Baseline|Placebo|Placebo administered orally twice daily.
435203|NCT00529659|B1|Baseline|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435204|NCT00529659|P2|Participant Flow|Placebo|Placebo administered orally twice daily.
435205|NCT00529659|P1|Participant Flow|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435206|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435207|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435208|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435209|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435210|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435211|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435212|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435213|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435214|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435215|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435216|NCT00529659|O2|Outcome|Placebo|Placebo administered orally twice daily.
435217|NCT00529659|O1|Outcome|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435218|NCT00529659|E2|Reported Event|Placebo|Placebo administered orally twice daily.
435219|NCT00529659|E1|Reported Event|MK-0773|MK-0773 was administered orally twice daily (BID) at a dose of 50 mg.
435220|NCT00529633|B3|Baseline|Total|Total of all reporting groups
435221|NCT00529633|B2|Baseline|Placebo|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Placebo for a period of 24 weeks."
435222|NCT00529633|B1|Baseline|Thalidomid|"12 End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.100 mg by mouth at night for 4 weeks; then if tolerated, Thalidomid will be increased to 200 mg by mouth at night for 20 weeks; for a total of 24 weeks on Thalidomid"
435223|NCT00529633|P2|Participant Flow|Thalidomide|"End stage renal disease (ESRD) patients on hemodialysis for at least 3 months~Serum C reactive protein level of ≥ 0.8 mg/dl~Serum albumin < 3.8 g/dl (BCG)~Patients will receive Thalidomide for a period of 24 weeks.~Blood will be drawn every 4 weeks for a total of 28 weeks to establish the effect on albumin, prealbumin and CRP~Thalidomide : 100 mg by mouth at night for 4 weeks 200 mg by mouth at night for 20 weeks"
435330|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435331|NCT00529542|O2|Outcome|Placebo|Placebo qd
435332|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435333|NCT00529542|O2|Outcome|Placebo|Placebo qd
435334|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435224|NCT00529633|P1|Participant Flow|Placebo|"This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks.~Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin. Subject must meet capsule count of >85% compliance with regard to medication and/or birth control requirements as outlined in the S.T.E.P.S ® in the first 4 weeks of study program"
435225|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
435226|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
435227|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
435228|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
435229|NCT00529633|O2|Outcome|Placebo|Placebo Control--This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with a placebo for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin
435230|NCT00529633|O1|Outcome|Thalidomide|This arm will consist of hemodialysis patients having elevated CRP and low albumin levels (less than 3.8 by BCG) who will be treated with Thalidomide for 24 weeks. Blood will be drawn every 4 weeks for measurement of CRP, albumin and prealbumin Dosage at 2x 50mg each night; if somnolence tolerated, dosage will increase to 4x50mg per night
435231|NCT00529633|E2|Reported Event|Placebo|
435232|NCT00529633|E1|Reported Event|Thalidomide|
435233|NCT00529568|B3|Baseline|Total|Total of all reporting groups
435234|NCT00529568|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435235|NCT00529568|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435236|NCT00529568|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435237|NCT00529568|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435238|NCT00529568|P1|Participant Flow|Eltrombopag: Open-label Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the Open-label Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
435239|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435240|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435241|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435242|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435243|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435244|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435245|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435246|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435247|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435248|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435249|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to &gt;=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435250|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435251|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435252|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435253|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435254|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435255|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435256|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435257|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435258|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435259|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435260|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435261|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435262|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435335|NCT00529542|O2|Outcome|Placebo|Placebo qd
435336|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435337|NCT00529542|O2|Outcome|Placebo|Placebo qd
435338|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435339|NCT00529542|E2|Reported Event|Placebo|Placebo qd
435263|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435264|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435265|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435266|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435267|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435268|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435269|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435270|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435271|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435272|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435273|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435274|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435275|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435276|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435277|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
435278|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
435340|NCT00529542|E1|Reported Event|Atorvastatin|Atorvastatin, 40 mg qd
435341|NCT00529529|B4|Baseline|Total|Total of all reporting groups
435413|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435279|NCT00529568|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
435280|NCT00529568|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435281|NCT00529568|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435282|NCT00529568|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=100 Gi/L) in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435283|NCT00529568|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2b and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
435284|NCT00529568|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of &lt;75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was &lt;100 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained &lt;100 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts &gt;=100 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts &gt;=100 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
435285|NCT00529555|B4|Baseline|Total|Total of all reporting groups
435286|NCT00529555|B3|Baseline|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
435287|NCT00529555|B2|Baseline|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
435288|NCT00529555|B1|Baseline|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
435289|NCT00529555|P3|Participant Flow|Scaling and Root Planing + Vehicle|Gel WITHOUT 2.1% Minocycline HCl + Scaling and root planing
435290|NCT00529555|P2|Participant Flow|Scaling & Root Planing + Periocline Gel|"Gel WITH Minocycline HCL 2.1% + Scaling & root planing~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
435291|NCT00529555|P1|Participant Flow|Scaling and Root Planing + SHAM TX|Empty syringe + Scaling and root planing
435292|NCT00529555|O3|Outcome|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
435293|NCT00529555|O2|Outcome|Scaling and Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
435294|NCT00529555|O1|Outcome|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
435295|NCT00529555|E3|Reported Event|Scaling and Root Planing + Vehicle|"Placebo~Scaling and root planing : scaling and root planing"
435296|NCT00529555|E2|Reported Event|Scaling & Root Planing + Periocline Gel|"Minocycline HCL 2.1%~minocycline HCl 2.1% : Minocycline HCl 2.1% gel as an adjunct to scaling and root planing. Dosing is by topical delivery into gingival pockets at baseline, 2 weeks, 4 weeks, 3 months and 6 months."
435297|NCT00529555|E1|Reported Event|Scaling and Root Planing + SHAM TX|"sham treatment~Scaling and root planing : scaling and root planing"
435298|NCT00529542|B3|Baseline|Total|Total of all reporting groups
435299|NCT00529542|B2|Baseline|Placebo|Placebo qd
435300|NCT00529542|B1|Baseline|Atorvastatin|Atorvastatin, 40 mg qd
435301|NCT00529542|P2|Participant Flow|Placebo|Placebo qd
435302|NCT00529542|P1|Participant Flow|Atorvastatin|Atorvastatin, 40 mg qd
435303|NCT00529542|O2|Outcome|Placebo|Placebo qd
435304|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435305|NCT00529542|O2|Outcome|Placebo|Placebo qd
435306|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435307|NCT00529542|O2|Outcome|Placebo|Placebo qd
435308|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435309|NCT00529542|O2|Outcome|Placebo|Placebo qd
435310|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435311|NCT00529542|O2|Outcome|Placebo|Placebo qd
435312|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435313|NCT00529542|O2|Outcome|Placebo|Placebo qd
435314|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435315|NCT00529542|O2|Outcome|Placebo|Placebo qd
435316|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435317|NCT00529542|O2|Outcome|Placebo|Placebo qd
435318|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435319|NCT00529542|O2|Outcome|Placebo|Placebo qd
435320|NCT00529542|O1|Outcome|Atorvastatin|Atorvastatin, 40 mg qd
435321|NCT00529542|O2|Outcome|Placebo|Placebo qd
435342|NCT00529529|B3|Baseline|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435343|NCT00529529|B2|Baseline|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435344|NCT00529529|B1|Baseline|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435345|NCT00529529|P3|Participant Flow|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435346|NCT00529529|P2|Participant Flow|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435347|NCT00529529|P1|Participant Flow|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435348|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435349|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435350|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435351|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435352|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435353|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435354|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435519|NCT00529399|B4|Baseline|Total|Total of all reporting groups
435355|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435356|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435357|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435358|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435359|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435360|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435361|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435362|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435363|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435364|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435365|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435366|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435367|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435652|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435368|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435369|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435370|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435371|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435372|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435373|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435374|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435375|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435376|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435377|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435378|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435379|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435380|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435653|NCT00529087|O3|Outcome|Placebo|Once daily
435381|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435382|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435383|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435384|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435385|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435386|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435387|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435388|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435389|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435390|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435391|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435392|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435393|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
436546|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
435394|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435395|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435396|NCT00529529|O3|Outcome|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435397|NCT00529529|O2|Outcome|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435398|NCT00529529|O1|Outcome|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435399|NCT00529529|E3|Reported Event|Salmeterol 50 μg|Patients received salmeterol 50 μg delivered via the salmeterol proprietary dry powder inhalation device bis in die (bid, twice daily), once in the morning (between 7:00 and 11:00 AM) and once in the evening (between 7:00 and 11:00 PM). In addition to salmeterol 50 μg, patients received 2 indacaterol placebo inhalations in the morning. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435400|NCT00529529|E2|Reported Event|Indacaterol 600 μg|Patients received indacaterol 600 μg (2 x 300 μg capsules) delivered via single dose dry powder inhalers (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 600 μg, patients received salmeterol placebo inhalation in the morning and the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435401|NCT00529529|E1|Reported Event|Indacaterol 300 μg|Patients received indacaterol 300 μg delivered via a single dose dry powder inhaler (SDDPI) once daily (od) in the morning (between 7:00 and 11:00 AM). In addition to indacaterol 300 μg, patients received indacaterol and salmeterol placebo inhalations in the morning and salmeterol placebo inhalation in the evening (between 7:00 and 11:00 PM). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
435402|NCT00529516|B4|Baseline|Total|Total of all reporting groups
435403|NCT00529516|B3|Baseline|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435404|NCT00529516|B2|Baseline|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435405|NCT00529516|B1|Baseline|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435406|NCT00529516|P3|Participant Flow|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435407|NCT00529516|P2|Participant Flow|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435408|NCT00529516|P1|Participant Flow|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435409|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435410|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435411|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435412|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
436547|NCT00527787|E2|Reported Event|Naproxen|Naproxen 500 mg
435414|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435415|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435416|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435417|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435418|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435419|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435420|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435421|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435422|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435423|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435424|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435425|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435426|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435427|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435428|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435429|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435430|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435431|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435432|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435433|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435434|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435435|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435436|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435437|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435438|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435439|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435440|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435441|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435442|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435443|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435444|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435445|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435446|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435447|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435448|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435449|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435450|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435451|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435452|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435453|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435454|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435455|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435456|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435457|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435458|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435459|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435460|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435461|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435462|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435463|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435464|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435465|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435466|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435467|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435468|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435469|NCT00529516|O3|Outcome|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435470|NCT00529516|O2|Outcome|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435471|NCT00529516|O1|Outcome|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435472|NCT00529516|E3|Reported Event|Fluarix 18-40 Years Age Group|Subjects aged between 18 and 40 years, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435473|NCT00529516|E2|Reported Event|Fluarix ≥ 65 Years Age Group|Subjects aged 65 years and above, who had received one dose of Fluarix™ vaccine in study NCT00377585, received one dose of Fluarix™ vaccine in the current study.
435474|NCT00529516|E1|Reported Event|FluAS25 Group|Subjects aged 65 years and above, who had received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in study NCT00377585, received one dose of GlaxoSmithKline (GSK) Biologicals’ AS25 adjuvanted influenza vaccine (GSK576389A) in the current study.
435475|NCT00529464|B4|Baseline|Total|Total of all reporting groups
435476|NCT00529464|B3|Baseline|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
435477|NCT00529464|B2|Baseline|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
435478|NCT00529464|B1|Baseline|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
435479|NCT00529464|P3|Participant Flow|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
435480|NCT00529464|P2|Participant Flow|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
435481|NCT00529464|P1|Participant Flow|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
435482|NCT00529464|O3|Outcome|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
435483|NCT00529464|O2|Outcome|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
435484|NCT00529464|O1|Outcome|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
435485|NCT00529464|E3|Reported Event|Colposcopy + LEEP|Colposcopy - a direct magnified inspection of cervix + loop electrosurgical excision procedure (LEEP) - thin, low-voltage electrified wire loop to cuts out cervix abnormal tissue.
435486|NCT00529464|E2|Reported Event|Colposcopy + Fluorescence Spectroscopy|Colposcopy - a direct magnified inspection of cervix + Fluorescence Spectroscopy - electromagnetic spectroscopy which analyzes fluorescence from a sample.
435487|NCT00529464|E1|Reported Event|Colposcopy|Colposcopy - a direct magnified inspection of cervix.
435488|NCT00529451|B5|Baseline|Total|Total of all reporting groups
435489|NCT00529451|B4|Baseline|Ramipril 5 mg|Ramipril 5 mg once daily
435490|NCT00529451|B3|Baseline|Aliskiren 75 mg|Aliskiren 75 mg once daily
435491|NCT00529451|B2|Baseline|Aliskiren 150 mg|Aliskiren 150 mg once daily
435492|NCT00529451|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg once daily
435493|NCT00529451|P4|Participant Flow|Ramipril 5 mg|Ramipril 5 mg once daily
435494|NCT00529451|P3|Participant Flow|Aliskiren 75 mg|Aliskiren 75 mg once daily
435495|NCT00529451|P2|Participant Flow|Aliskiren 150 mg|Aliskiren 150 mg once daily
435496|NCT00529451|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg once daily
435497|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435498|NCT00529451|O1|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
435499|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435500|NCT00529451|O1|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
435501|NCT00529451|O2|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435502|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
435503|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435504|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
435505|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
435506|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
435507|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435508|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
435509|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
435510|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
435511|NCT00529451|O4|Outcome|Ramipril 5 mg|Ramipril 5 mg once daily
435512|NCT00529451|O3|Outcome|Aliskiren 75 mg|Aliskiren 75 mg once daily
435513|NCT00529451|O2|Outcome|Aliskiren 150 mg|Aliskiren 150 mg once daily
435514|NCT00529451|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg once daily
435515|NCT00529451|E4|Reported Event|Ramipril 5 mg|Ramipril 5 mg once daily
435516|NCT00529451|E3|Reported Event|Aliskiren 75 mg|Aliskiren 75 mg once daily
435517|NCT00529451|E2|Reported Event|Aliskiren 150 mg|Aliskiren 150 mg once daily
435518|NCT00529451|E1|Reported Event|Aliskiren 300 mg|Aliskiren 300 mg once daily
435520|NCT00529399|B3|Baseline|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435521|NCT00529399|B2|Baseline|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
435522|NCT00529399|B1|Baseline|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435523|NCT00529399|P3|Participant Flow|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435524|NCT00529399|P2|Participant Flow|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
435525|NCT00529399|P1|Participant Flow|GAD-alum|"3 injections of Glutamic Acid Decarboxylase (GAD)-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435526|NCT00529399|O3|Outcome|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435527|NCT00529399|O2|Outcome|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
435528|NCT00529399|O1|Outcome|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435529|NCT00529399|E3|Reported Event|Alum Alone|"3 injections of Aluminum hydroxide alone~Aluminum hydroxide: Participants will receive 3 injections of Aluminum hydroxide alone, subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435530|NCT00529399|E2|Reported Event|GAD-alum Plus Alum|"2 injections of GAD-Alum vaccine and one injection with Aluminum hydroxide alone~GAD-Alum: Participants will receive 3 injections subcutaneously. The first two will contain 20 micrograms GAD-Alum vaccine and are given 4 weeks apart. The third injection will be Aluminum hydroxide alone and will be given 8 weeks after the second injection."
435531|NCT00529399|E1|Reported Event|GAD-alum|"3 injections of GAD-Alum vaccine~GAD-Alum: Participants will receive 3 injections of 20 micrograms GAD-Alum subcutaneously. The first two injections are given 4 weeks apart and the second and third are given 8 weeks apart."
435532|NCT00529308|B3|Baseline|Total|Total of all reporting groups
435533|NCT00529308|B2|Baseline|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435534|NCT00529308|B1|Baseline|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435535|NCT00529308|P2|Participant Flow|Sham|
435536|NCT00529308|P1|Participant Flow|Active rTMS|
435537|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435538|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435539|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435540|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435541|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435542|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435543|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435544|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435545|NCT00529308|O2|Outcome|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435546|NCT00529308|O1|Outcome|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435547|NCT00529308|E2|Reported Event|Sham|Magstim Rapid2 stimulator with Sham Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435548|NCT00529308|E1|Reported Event|Active|Magstim Rapid2 stimulator with Air Film Coil at 110% motor threshold at 1Hz for 30 minutes.
435549|NCT00529282|B3|Baseline|Total|Total of all reporting groups
435550|NCT00529282|B2|Baseline|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435551|NCT00529282|B1|Baseline|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435552|NCT00529282|P2|Participant Flow|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435553|NCT00529282|P1|Participant Flow|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435554|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435555|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435556|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435557|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
436548|NCT00527787|E1|Reported Event|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
435558|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435559|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435560|NCT00529282|O2|Outcome|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435561|NCT00529282|O1|Outcome|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435562|NCT00529282|E2|Reported Event|Cefepime With or Without Vancomycin|2 g every 8 hrs-30 min infusion vancomycin 1,000mg every 12 hrs-60 min infusion
435563|NCT00529282|E1|Reported Event|Ceftobiprole Medocaril|500 mg every 8 hours - 120-minute infusion [250 mL]
435564|NCT00529243|B1|Baseline|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
435565|NCT00529243|P1|Participant Flow|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
435566|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
435567|NCT00529243|O1|Outcome|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
435568|NCT00529243|E1|Reported Event|MK-0518 (Raltegravir)|Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
435569|NCT00529217|B1|Baseline|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
435570|NCT00529217|P1|Participant Flow|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
435571|NCT00529217|O1|Outcome|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
435572|NCT00529217|O1|Outcome|Open-Label, rTMS, Active Coil|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
435573|NCT00529217|E1|Reported Event|Open-Label Active|Repetitive Transcranial Magnetic Stimulation (rTMS) : Strong electromagnetic fields (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) applied for 30mins, in five sessions per week for up to twelve weeks.
435574|NCT00529204|B1|Baseline|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435575|NCT00529204|P1|Participant Flow|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435576|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435577|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435578|NCT00529204|O1|Outcome|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435579|NCT00529204|E1|Reported Event|Exenatide|"exenatide 5 µg BID s.c. daily for 28 days, followed by 10 µg BID s.c. daily from day 29 to week 24~exenatide: Subjects meeting the inclusion criteria will be treated with exenatide 5 µg BID s.c. for 3-7 days, followed by 10 µg BID s.c. daily to week 24"
435580|NCT00529191|B3|Baseline|Total|Total of all reporting groups
435581|NCT00529191|B2|Baseline|Placebo|Placebo treatment
435582|NCT00529191|B1|Baseline|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
435583|NCT00529191|P2|Participant Flow|Placebo|Placebo treated. Patients will receive tablets daily.There will be 12 months of treatment followed by 6 months of a washout period.
435584|NCT00529191|P1|Participant Flow|Atorvastatin|Two out of every 3 patients will receive atorvastatin in tablet form. The subject will start on 10mg of atorvastatin daily for four weeks, and then titrate up to 20mg daily. There will be 12 months of treatment followed by 6 months of a washout period.
435585|NCT00529191|O2|Outcome|Placebo|Placebo treatment
435586|NCT00529191|O1|Outcome|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
435587|NCT00529191|E2|Reported Event|Placebo|Placebo treatment
435588|NCT00529191|E1|Reported Event|Atorvastatin|Two out of every 3 patients will receive atorvastatin.
435589|NCT00529152|B1|Baseline|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
435590|NCT00529152|P1|Participant Flow|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
435591|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
435654|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435655|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435592|NCT00529152|O1|Outcome|Ferriprox Oral Solution|All subjects were administered Ferriprox Oral Solution three times daily for a total daily dose of either 50, 75 or 100 mg/kg/day. Subjects were initiated at a dose of 50 mg/kg/day, but this dose could be increased after two weeks of therapy depending on the subjects' individual needs.
435593|NCT00529126|B5|Baseline|Total|Total of all reporting groups
435594|NCT00529126|B4|Baseline|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
435595|NCT00529126|B3|Baseline|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435596|NCT00529126|B2|Baseline|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435597|NCT00529126|B1|Baseline|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435598|NCT00529126|P4|Participant Flow|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
435599|NCT00529126|P3|Participant Flow|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435600|NCT00529126|P2|Participant Flow|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435601|NCT00529126|P1|Participant Flow|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435602|NCT00529126|O4|Outcome|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
435603|NCT00529126|O3|Outcome|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435604|NCT00529126|O2|Outcome|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435605|NCT00529126|O1|Outcome|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435606|NCT00529126|E4|Reported Event|Bupivacaine HCl|A single dose of 75 mg bupivacaine was to be administered intraoperatively via local infiltration
435607|NCT00529126|E3|Reported Event|SKY0402 Low Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435608|NCT00529126|E2|Reported Event|SKY0402 Middle Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435609|NCT00529126|E1|Reported Event|SKY0402 High Dose|A single dose of study drug was to be administered intraoperatively via local infiltration.
435610|NCT00529100|B4|Baseline|Total|Total of all reporting groups
435611|NCT00529100|B3|Baseline|Pemetrexed/Cisplatin/Radiation Phase 2|Participants were strictly in Phase 2. Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m2 IV.
435612|NCT00529100|B2|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1-Phase 2|Participants were overlap in Phase 1 and Phase 2.
435613|NCT00529100|B1|Baseline|Pemetrexed/Cisplatin/Radiation Phase 1|Participants were strictly in Phase 1. Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435614|NCT00529100|P2|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435615|NCT00529100|P1|Participant Flow|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) IV through 500 mg/m^2 IV on Days 1 and 22; concurrent cisplatin 25 mg/m^2 IV on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 IV on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (every 3 weeks [q3 weeks]) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435616|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435617|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435618|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435619|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435656|NCT00529087|O3|Outcome|Placebo|Once daily
435620|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment and 62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 IV and cisplatin 75 mg/m^2 IV.
435621|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
435622|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
435623|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed 500 mg/m^2 as determined by phase 1 trial on Days 1 and 22; concurrent cisplatin 20 mg/m^2 as determined by phase 1 trial with cycles commencing on Days 1 and 22; two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m2.
435624|NCT00529100|O1|Outcome|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on days 1-5 and 22-26 for cohort four. Participants then received two additional consolidation cycles (q3 weekly) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
435625|NCT00529100|E3|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 2|Treatment included: radiation, 61-65 Gy in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed IV bolus as determined by Phase 1 trial on Days 1 and 22; concurrent cisplatin as determined by Phase 1 trial with cycles commencing on Days 1 and 22; and two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
435626|NCT00529100|E2|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1-2|"Cohort 4 data from Phase (Ph) 1 was included in the Ph 2 analysis as Cohort 4 was the established dose from Ph 1.~Ph 1: radiation as 61-65 Gray (Gy) in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first 3 cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.~Ph 2: radiation, 61-65 Gy in 33-35 fractions if 2-phase treatment/62-66 Gy in 31-33 fractions if 1-phase treatment; concurrent pemetrexed IV bolus from Ph 1 trial on Days 1 and 22; concurrent cisplatin from Ph 1 trial with cycles commencing on Days 1 and 22; and 2 additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2."
435627|NCT00529100|E1|Reported Event|Pemetrexed/Cisplatin/Radiation Phase 1|Treatment included: radiation as 61-65 Gray (Gy) in 33-35 fractions if two-phase treatment and 62-66 Gy in 31-33 fractions if one-phase treatment; concurrent pemetrexed intravenous (IV) bolus with doses escalating from 300 milligrams per square meter (mg/m^2) through 500 mg/m^2 on Days 1 and 22; concurrent cisplatin 25 mg/m^2 on Days 1-3 and 22-24 for the first three cohorts and cisplatin 20 mg/m^2 on Days 1-5 and 22-26 for Cohort 4. Participants then received two additional consolidation cycles (q3 weeks) of pemetrexed 500 mg/m^2 and cisplatin 75 mg/m^2.
435628|NCT00529087|B4|Baseline|Total|Total of all reporting groups
435629|NCT00529087|B3|Baseline|Placebo (Double-blind)|Once daily for weeks 1 through 4
435630|NCT00529087|B2|Baseline|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
435631|NCT00529087|B1|Baseline|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
435632|NCT00529087|P3|Participant Flow|Placebo (Double-blind)|Once daily for weeks 1 through 4
435633|NCT00529087|P2|Participant Flow|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
435634|NCT00529087|P1|Participant Flow|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
435635|NCT00529087|O3|Outcome|Placebo|Once daily
435636|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435637|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435638|NCT00529087|O3|Outcome|Placebo|Once daily
435639|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435640|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435641|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
435642|NCT00529087|O3|Outcome|Placebo|Once daily
435643|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435644|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435645|NCT00529087|O3|Outcome|Placebo|Once daily
435646|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435647|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435648|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
435649|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
435650|NCT00529087|O3|Outcome|Placebo|Once daily
435651|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435657|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435658|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435659|NCT00529087|O3|Outcome|Placebo|Once daily
435660|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435661|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435662|NCT00529087|O3|Outcome|Placebo|Once daily
435663|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435664|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435665|NCT00529087|O3|Outcome|Placebo|Once daily
435666|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435667|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435668|NCT00529087|O3|Outcome|Placebo|Once daily
435669|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435670|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435671|NCT00529087|O3|Outcome|Placebo|Once daily
435672|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435673|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435674|NCT00529087|O4|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
435675|NCT00529087|O3|Outcome|Placebo|Once daily
435676|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day, Placebo once daily on alternating days
435677|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435678|NCT00529087|O3|Outcome|Placebo|Once daily
435679|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435680|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435681|NCT00529087|O1|Outcome|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) during weeks 5 through 12
435682|NCT00529087|O3|Outcome|Placebo|Once daily
435683|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435684|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435685|NCT00529087|O2|Outcome|Placebo|Once daily
435686|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 12 mg once daily (QD) and MOA-728 12 mg once every other day (QOD), Placebo once daily on alternating days
435687|NCT00529087|O4|Outcome|Placebo QD|Once daily
435688|NCT00529087|O3|Outcome|Placebo QD (Only QOD Injections)|Placebo group using odd numbered injections corresponding to the active injections in the MOA-728 QOD group. The same placebo patients of 162 was used for each active drug group (QD and QOD).
435689|NCT00529087|O2|Outcome|MOA-728 QOD|MOA-728 12 mg once every other day (QOD), with placebo once daily on alternating days
435690|NCT00529087|O1|Outcome|MOA-728 QD|MOA-728 12 mg once daily (QD)
435691|NCT00529087|O2|Outcome|Placebo|Once daily
435692|NCT00529087|O1|Outcome|MOA-728 QD and MOA-728 QOD|MOA-728 QD treatment group (12 mg every day) and MOA-728 QOD treatment group (12 mg once every other day, with placebo once daily on alternating days).
435693|NCT00529087|E4|Reported Event|MOA-728 PRN (Open-label)|MOA-728 12 mg as needed (PRN) for weeks 5 through 12
435694|NCT00529087|E3|Reported Event|Placebo (Double-blind)|Once daily for weeks 1 through 4
435695|NCT00529087|E2|Reported Event|MOA-728 QOD (Double-blind)|MOA-728 12 mg once every other day, Placebo once daily on alternating days for weeks 1 through 4
435696|NCT00529087|E1|Reported Event|MOA-728 QD (Double-blind)|MOA-728 12 mg once daily (QD) for weeks 1 through 4
435697|NCT00529035|B1|Baseline|Group 1|
435698|NCT00529035|P1|Participant Flow|Ultra-low Dose Interleukin-2|"Daily subcutaneous administration of Interleukin-2 evaluated at three dose levels:~Dose level A: 0.3 x 10^6 IU/m^2/day Dose level B: 1.0 x 10^6 IU/m^2/day Dose level C: 3.0 x 10^6 IU/M^2/day"
435699|NCT00529035|O3|Outcome|Median Treg:Tcon Ratio at Week 12|Immune-cell ratio after a 4 weeks off IL-2 per protocol
435700|NCT00529035|O2|Outcome|Median Treg:Tcon Ratio at Week 8|Immune-cell ratio after 8 weeks of IL-2 therapy
435701|NCT00529035|O1|Outcome|Median Treg:Tcon Ratio at Baseline|Immune-cell ratio before the start of IL-2 therapy
435702|NCT00529035|O3|Outcome|Median Absolute Cell Count at Week 12|Immune-cell counts after a 4 weeks off IL-2 per protocol
435703|NCT00529035|O2|Outcome|Median Absolute Cell Counts at Week 8|Immune-cell counts after 8 weeks of IL-2 therapy
435704|NCT00529035|O1|Outcome|Median Absolute Cell Counts at Baseline|Immune-cell counts before the start of IL-2 therapy
435705|NCT00529035|O1|Outcome|Ultra-low Dose Interleukin-2|
435706|NCT00529035|O1|Outcome|Ultra-low Dose IL-2 MTD|
435707|NCT00529035|E1|Reported Event|Ultra-low Dose Interleukin-2|
435708|NCT00527124|B3|Baseline|Total|Total of all reporting groups
435709|NCT00527124|B2|Baseline|Arm II|Patients receive docetaxel and prednisone as in arm I.
435710|NCT00527124|B1|Baseline|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
435711|NCT00527124|P2|Participant Flow|Arm II|Patients receive docetaxel and prednisone as in arm I.
435712|NCT00527124|P1|Participant Flow|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
435713|NCT00527124|O2|Outcome|Arm II|Patients receive docetaxel 75 mg/m2 IV every 3 weeks, and prednisone 5mg orally twice a day, Repeat cycle every 21 days.
435714|NCT00527124|O1|Outcome|Arm I|Patients receive oral cediranib 20 mg once daily on days 1-21, docetaxel 75mg/m2 IV over 1 hour on day 1 every 3 weeks, and oral prednisone 5mg twice daily on days 1-21.
435715|NCT00527124|E2|Reported Event|Arm II|Patients receive docetaxel and prednisone as in arm I.
435716|NCT00527124|E1|Reported Event|Arm I|Patients receive oral cediranib once daily on days 1-21, docetaxel IV over 1 hour on day 1, and oral prednisone twice daily on days 1-21.
435718|NCT00528957|B2|Baseline|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435719|NCT00528957|B1|Baseline|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435720|NCT00528957|P2|Participant Flow|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435721|NCT00528957|P1|Participant Flow|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435722|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435723|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435724|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435725|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435726|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435727|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435728|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435729|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
435730|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
435731|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435732|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435733|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435734|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435735|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435736|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435737|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435738|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks).
435739|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks).
435740|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435741|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435742|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435743|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435744|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s).
435745|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435746|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435747|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
435748|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
435749|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases (All TDF group)
435750|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
435751|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s)
435752|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435753|NCT00528957|O2|Outcome|(Stavudine or Zidovudine)/TDF|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks) and then received TDF during the extension phase(s)
435754|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks) and continued to receive TDF during the extension phase(s).
435755|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
435756|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
435757|NCT00528957|O3|Outcome|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435758|NCT00528957|O2|Outcome|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
435759|NCT00528957|O1|Outcome|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
435760|NCT00528957|E3|Reported Event|All TDF|All participants who received tenofovir DF in the randomized and/or extension phases
435761|NCT00528957|E2|Reported Event|Stavudine or Zidovudine|Participants in this group received stavudine or zidovudine during the randomized phase (48 weeks)
435762|NCT00528957|E1|Reported Event|Tenofovir DF|Participants in this group received TDF during the randomized phase (48 weeks)
435763|NCT00528931|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
435764|NCT00528931|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
435765|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
435766|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
435767|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
435768|NCT00528931|O1|Outcome|AA4500 0.58 mg|Collagenase clostridium histolyticum 0.58 mg injected into either the MP or PIP joint
435769|NCT00528931|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
435770|NCT00528931|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into either the metacarpophalangeal (MP) or proximal interphalangeal (PIP) joint
435771|NCT00528879|B5|Baseline|Total|Total of all reporting groups
435772|NCT00528879|B4|Baseline|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435773|NCT00528879|B3|Baseline|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435774|NCT00528879|B2|Baseline|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435775|NCT00528879|B1|Baseline|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435776|NCT00528879|P4|Participant Flow|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435777|NCT00528879|P3|Participant Flow|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435778|NCT00528879|P2|Participant Flow|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435779|NCT00528879|P1|Participant Flow|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435780|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435781|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435782|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435783|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435784|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435785|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435786|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435787|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435788|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435789|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435790|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435791|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435792|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435793|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435794|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435795|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435796|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435797|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435798|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435799|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435800|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435801|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435802|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435803|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435804|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435805|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435806|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435807|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435808|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435809|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435810|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435811|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435812|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435813|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435814|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435815|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435816|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435817|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435818|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435819|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435820|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435821|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435822|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435823|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435824|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435825|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435826|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435827|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435828|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435829|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435830|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435831|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435832|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435833|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435834|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435835|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435836|NCT00528879|O4|Outcome|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435837|NCT00528879|O3|Outcome|Dapagliflozin, 5 mg + Metformin|Participants received dapagliflozin, 5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435838|NCT00528879|O2|Outcome|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
436549|NCT00527735|B4|Baseline|Total|Total of all reporting groups
435839|NCT00528879|O1|Outcome|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435840|NCT00528879|E4|Reported Event|Dapagliflozin, 10 mg + Metformin|Participants received dapagliflozin, 10 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435841|NCT00528879|E3|Reported Event|Dapagliflozin, 5.0 mg + Metformin|Participants received dapagliflozin, 5.0 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435842|NCT00528879|E2|Reported Event|Dapagliflozin, 2.5 mg + Metformin|Participants received dapagliflozin, 2.5 mg, once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435843|NCT00528879|E1|Reported Event|Placebo + Metformin|Participants received dapagliflozin-matching placebo once daily plus open-label metformin ≥1500 mg per day for up to 102 weeks
435844|NCT00528840|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435845|NCT00528840|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435846|NCT00528840|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435847|NCT00528840|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435848|NCT00528801|B3|Baseline|Total|Total of all reporting groups
435849|NCT00528801|B2|Baseline|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435850|NCT00528801|B1|Baseline|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435851|NCT00528801|P2|Participant Flow|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435852|NCT00528801|P1|Participant Flow|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435853|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435854|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435855|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435856|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435857|NCT00528801|O2|Outcome|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435858|NCT00528801|O1|Outcome|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435859|NCT00528801|E2|Reported Event|Phase I: Controls|These are patients that do not have sickle cell disease (confirmed by hemoglobin electrophoresis); matched to cases by age, gender, and education level
435860|NCT00528801|E1|Reported Event|Phase I: Cases|These are patients diagnosed with sickle cell disease (confirmed by hemoglobin electrophoresis).
435861|NCT00528788|B1|Baseline|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol : 2 or 4 mcg"
435862|NCT00528788|P1|Participant Flow|Pre Doxercalciferol/Post Doxercalciferol|"all end stage renal disease patients with secondary hyperparathyroidism who are vitamin D naive~compared pre- and post doxercalciferol."
435863|NCT00528788|O1|Outcome|Pre-post Comparison|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol"
435864|NCT00528788|E1|Reported Event|Pre and Post Doxicalciferol|"ESRD: all patients with secondary hyperparathyroidism who are vitamin D naive~doxercalciferol 2 mcg or 4 mcg three times per week for 1 month"
435865|NCT00528775|B1|Baseline|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435866|NCT00528775|P1|Participant Flow|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435867|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435868|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435869|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435870|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435871|NCT00528775|O1|Outcome|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435872|NCT00528775|E1|Reported Event|HPPH|"Patients will receive 4 mg/m2 HPPH (given light exposure precautions) and approximately 2 days later be treated endoscopically with 150J/cm of 665 +-5nm light.~HPPH: 4 mg/m2 IV~endoscopic procedure: Treatment with 150 joules from laser"
435920|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435921|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
438502|NCT00522431|E1|Reported Event|Safety Popluation (All Patients)|
435873|NCT00528645|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity. Blood samples are obtained at baseline and periodically during study to determine levels of circulating tumor cells for defined translational studies.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
435874|NCT00528645|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks"
435875|NCT00528645|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 once daily for up to 2 years in the absence of disease progression or unacceptable toxicity.~saracatinib: saracatinib 175mg given orally daily with re-treatment every 3 weeks"
435876|NCT00528645|E1|Reported Event|Treatment (Saracatinib)|saracatinib : saracatinib 175mg given orally daily with re-treatment every 3 weeks
435877|NCT00528606|B3|Baseline|Total|Total of all reporting groups
435878|NCT00528606|B2|Baseline|Placebo|
435879|NCT00528606|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435880|NCT00528606|P2|Participant Flow|Placebo|
435881|NCT00528606|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435882|NCT00528606|O2|Outcome|Placebo|
435883|NCT00528606|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435884|NCT00528606|E2|Reported Event|Placebo|
435885|NCT00528606|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435886|NCT00528567|B3|Baseline|Total|Total of all reporting groups
435887|NCT00528567|B2|Baseline|Chemotherapy|Participants randomized to receive chemotherapy alone
435888|NCT00528567|B1|Baseline|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435889|NCT00528567|P2|Participant Flow|Chemotherapy|"Participants randomized to receive chemotherapy alone.~For patients randomized to the chemotherapy alone arm, investigators could select from one of three chemotherapy regimens. After completing chemotherapy (treatment period 1) patients entered a post-treatment surveillance period for the remainder of the first year after randomization (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
435890|NCT00528567|P1|Participant Flow|Bevacizumab and Chemotherapy|"Participants randomized to receive bevacizumab and chemotherapy.~For these patients, bevacizumab was given in combination with chemotherapy at a dose of 5 mg/kg/week equivalent using 1 of 3 different scheduling options depending on the schedule of the adjuvant chemotherapy selected. After completing chemotherapy + bevacizumab (treatment period 1), patients in this arm received bevacizumab monotherapy up to a total duration of 1 year (treatment period 2).~At the end of treatment (i.e., after approximately 55 weeks), patients were followed up until the end of the study."
435891|NCT00528567|O4|Outcome|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, more than 18 months after first dose
435892|NCT00528567|O3|Outcome|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, more than 18 months after first dose
435893|NCT00528567|O2|Outcome|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, 0-18 months after first dose
435894|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, 0-18 months after first dose
435895|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435896|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435897|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435898|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435899|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435900|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435901|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435902|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435903|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435904|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435905|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435906|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435907|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
435908|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435909|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435910|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435911|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
435912|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435913|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435914|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435915|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy alone
435916|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435917|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
435918|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435919|NCT00528567|O2|Outcome|Chemotherapy|Participants randomized to receive chemotherapy
435922|NCT00528567|O1|Outcome|Bevacizumab and Chemotherapy|Participants randomized to receive bevacizumab and chemotherapy
435923|NCT00528567|E4|Reported Event|Chemotherapy (>18 Months)|Occurring in participants who received chemotherapy alone, during follow-up period (>18 months) after first dose
435924|NCT00528567|E3|Reported Event|Bevacizumab and Chemotherapy (>18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during follow-up period (>18 months) after first dose
435925|NCT00528567|E2|Reported Event|Chemotherapy (0-18 Months)|Occurring in participants who received chemotherapy alone, during treatment period (0-18 months) after first dose
435926|NCT00528567|E1|Reported Event|Bevacizumab and Chemotherapy (0-18 Months)|Occurring in participants who received bevacizumab and chemotherapy, during treatment period (0-18 months) after first dose
435927|NCT00528541|B3|Baseline|Total|Total of all reporting groups
435928|NCT00528541|B2|Baseline|Dysport®|botulinum toxin type A (Dysport®)
435929|NCT00528541|B1|Baseline|BOTOX®|botulinum toxin type A (BOTOX®)
435930|NCT00528541|P2|Participant Flow|Dysport®|botulinum toxin type A (Dysport®)
435931|NCT00528541|P1|Participant Flow|BOTOX®|botulinum toxin type A (BOTOX®)
435932|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435933|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435934|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435935|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435936|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435937|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435938|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435939|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435940|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435941|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435942|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435943|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435944|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435945|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435946|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435947|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435948|NCT00528541|O2|Outcome|Dysport®|botulinum toxin type A (Dysport®)
435949|NCT00528541|O1|Outcome|BOTOX®|botulinum toxin type A (BOTOX®)
435950|NCT00528541|E2|Reported Event|Dysport®|botulinum toxin type A (Dysport®)
435951|NCT00528541|E1|Reported Event|BOTOX®|botulinum toxin type A (BOTOX®)
435952|NCT00528528|B5|Baseline|Total|Total of all reporting groups
435953|NCT00528528|B4|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435954|NCT00528528|B3|Baseline|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435955|NCT00528528|B2|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435956|NCT00528528|B1|Baseline|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435957|NCT00528528|P4|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435958|NCT00528528|P3|Participant Flow|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435959|NCT00528528|P2|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435960|NCT00528528|P1|Participant Flow|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435961|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435962|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
436014|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
435963|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435964|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435965|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435966|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435967|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435968|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435969|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435970|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435971|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435972|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435973|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435974|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435975|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435976|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435977|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435978|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435979|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435980|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435981|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435982|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435983|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435984|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435985|NCT00528528|O4|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435986|NCT00528528|O3|Outcome|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435987|NCT00528528|O2|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435988|NCT00528528|O1|Outcome|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435989|NCT00528528|E4|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435990|NCT00528528|E3|Reported Event|Telaprevir 1125 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435991|NCT00528528|E2|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2b/RBV Capsule|Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.
435992|NCT00528528|E1|Reported Event|Telaprevir 750 mg With Peg-IFN-alfa-2a/RBV Tablet|Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.
435993|NCT00528450|B1|Baseline|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
435994|NCT00528450|P1|Participant Flow|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
435995|NCT00528450|O1|Outcome|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
435996|NCT00528450|E1|Reported Event|All Patients|Tretinoin and Arsenic Trioxide With or Without Idarubicin
435997|NCT00528424|B1|Baseline|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435998|NCT00528424|P1|Participant Flow|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
435999|NCT00528424|O1|Outcome|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
436000|NCT00528424|E1|Reported Event|AA4500 0.58 mg|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
436001|NCT00528411|B4|Baseline|Total|Total of all reporting groups
436002|NCT00528411|B3|Baseline|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436003|NCT00528411|B2|Baseline|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436004|NCT00528411|B1|Baseline|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus Clopidogrel placebo loading and od maintenance doses
436005|NCT00528411|P3|Participant Flow|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
436006|NCT00528411|P2|Participant Flow|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg Twice Daily (od), plus ticagrelor placebo loading and Once Daily (bd) maintenance doses
436007|NCT00528411|P1|Participant Flow|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg Twice Daily (bd), plus clopidogrel placebo loading and Once Daily (od) maintenance doses
436008|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436009|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436010|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436011|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436012|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436013|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436263|NCT00528268|B3|Baseline|Total|Total of all reporting groups
436015|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436016|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436017|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436018|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436019|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436020|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436021|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436022|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436023|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436024|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436025|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436026|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436027|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436028|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436029|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436030|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436031|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436032|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436033|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436034|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436035|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436036|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436037|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436038|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436039|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436040|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436041|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436042|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436043|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436044|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436045|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436046|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436047|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436048|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436049|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436050|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436051|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436052|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436053|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436054|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436055|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436056|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436057|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436058|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436708|NCT00527488|B3|Baseline|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436059|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436060|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436061|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436062|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436063|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436064|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436065|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436066|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436067|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436068|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436069|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436070|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436071|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436072|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436073|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436074|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436075|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436076|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436077|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436078|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436079|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436080|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436081|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436082|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436083|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436084|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436085|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436086|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436087|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436088|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436089|NCT00528411|O3|Outcome|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436090|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436091|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436092|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436093|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436094|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436095|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436096|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436097|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436098|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436099|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436100|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436101|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436102|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436709|NCT00527488|B2|Baseline|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436103|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436104|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436105|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436106|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436107|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436108|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436109|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436110|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436111|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436112|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436113|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436114|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436115|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436116|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436117|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436118|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436119|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436120|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436121|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436122|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436123|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436124|NCT00528411|O2|Outcome|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436125|NCT00528411|O1|Outcome|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436126|NCT00528411|E3|Reported Event|Placebo|Ticagrelor 180 mg placebo loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436127|NCT00528411|E2|Reported Event|Clopidogrel|Clopidogrel 600 mg loading dose followed by 75 mg od, plus ticagrelor placebo loading and bd maintenance doses
436128|NCT00528411|E1|Reported Event|Ticagrelor|Ticagrelor 180 mg loading dose followed by 90 mg bd, plus clopidogrel placebo loading and od maintenance doses
436129|NCT00528398|B1|Baseline|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
436130|NCT00528398|P1|Participant Flow|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
436131|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
436132|NCT00528398|O1|Outcome|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
436133|NCT00528398|E1|Reported Event|Treatment (Idarubicin, Cytarabine)|All patients were analyzed together.
436134|NCT00528372|B10|Baseline|Total|Total of all reporting groups
436135|NCT00528372|B9|Baseline|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436136|NCT00528372|B8|Baseline|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436137|NCT00528372|B7|Baseline|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436138|NCT00528372|B6|Baseline|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436139|NCT00528372|B5|Baseline|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436140|NCT00528372|B4|Baseline|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436141|NCT00528372|B3|Baseline|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436302|NCT00527072|E1|Reported Event|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
436142|NCT00528372|B2|Baseline|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436143|NCT00528372|B1|Baseline|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436144|NCT00528372|P9|Participant Flow|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436145|NCT00528372|P8|Participant Flow|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436146|NCT00528372|P7|Participant Flow|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436147|NCT00528372|P6|Participant Flow|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436148|NCT00528372|P5|Participant Flow|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436149|NCT00528372|P4|Participant Flow|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436150|NCT00528372|P3|Participant Flow|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436151|NCT00528372|P2|Participant Flow|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436152|NCT00528372|P1|Participant Flow|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436153|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436154|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436155|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436156|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436157|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436158|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436159|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436160|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436161|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436162|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436163|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436164|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436165|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436166|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436167|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436168|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436169|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436170|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, PM, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436171|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, PM, once each evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436172|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436173|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436174|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436175|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436176|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436177|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436178|NCT00528372|O9|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436179|NCT00528372|O8|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436180|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436181|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436182|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436183|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436184|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436185|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436186|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo, AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. In addition, during the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436187|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436188|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436189|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436190|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436191|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436192|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436193|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436194|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436195|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436196|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436197|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436198|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436199|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436200|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436201|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436202|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436303|NCT00526994|B4|Baseline|Total|Total of all reporting groups
436304|NCT00526994|B3|Baseline|Control|no screen and no referral
436203|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436204|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436205|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436206|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436207|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436208|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436209|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436210|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436211|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436212|NCT00528372|O3|Outcome|Group 1: Dapaglifozon, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436213|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436214|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436215|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436216|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436217|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436218|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436219|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436220|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436221|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|"Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436222|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436653|NCT00527605|P1|Participant Flow|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436223|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436224|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436225|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436226|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436227|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436228|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436229|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436230|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436231|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436232|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with hemoglobin A1c (HbA1c) ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436233|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436234|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436235|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436236|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436237|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436238|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436239|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436240|NCT00528372|O2|Outcome|Group 2: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436241|NCT00528372|O1|Outcome|Group 2: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥10.1% and ≤12% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436305|NCT00526994|B2|Baseline|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436242|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436243|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436244|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436245|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436246|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436247|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, AM, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436248|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436249|NCT00528372|O7|Outcome|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436250|NCT00528372|O6|Outcome|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436251|NCT00528372|O5|Outcome|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria. During the long-term treatment period, participants received metformin, 500 mg, with the morning meal.
436252|NCT00528372|O4|Outcome|Group 1: Dapagliflozin, 10 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436253|NCT00528372|O3|Outcome|Group 1: Dapagliflozin, 5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436254|NCT00528372|O2|Outcome|Group 1: Dapagliflozin, 2.5 mg AM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436255|NCT00528372|O1|Outcome|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436256|NCT00528372|E7|Reported Event|Group 1: Dapagliflozin, 10 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436257|NCT00528372|E6|Reported Event|Group 1: Dapagliflozin, 5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436258|NCT00528372|E5|Reported Event|Group 1: Dapagliflozin, 2.5 mg PM|Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436259|NCT00528372|E4|Reported Event|Group 1: Dapagliflozin, 10 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 10 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436260|NCT00528372|E3|Reported Event|Group 1: Dapagliflozin, 5 mg AM|Participants with (HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 5 mg, once each morning for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436261|NCT00528372|E2|Reported Event|Group 1: Dapagliflozin, 2.5 mg AM|"Participants with HbA1c ≥7% and ≤10% at enrollment received dapagliflozin tablets, 2.5 mg, once each morning for up to 102 weeks.~Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria."
436262|NCT00528372|E1|Reported Event|Group 1: Dapagliflozin Placebo AM & PM|Participants with hemoglobin AIc (HbA1c) ≥7% and ≤10% at enrollment received dapagliflozin placebo once each morning and evening for up to 102 weeks. Participants also received metformin tablets, 500-2000 mg, orally as needed for rescue based on protocol specific criteria.
436264|NCT00528268|B2|Baseline|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436265|NCT00528268|B1|Baseline|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436266|NCT00528268|P2|Participant Flow|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436267|NCT00528268|P1|Participant Flow|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436268|NCT00528268|O2|Outcome|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436269|NCT00528268|O1|Outcome|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436270|NCT00528268|E2|Reported Event|Cohort 2|"Family history of SMA type II 0-6 months old Confirmation of no more than 4 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436271|NCT00528268|E1|Reported Event|Cohort 1|"Family history of SMA type I 0-3 months old Confirmation of no more than 3 SMN2 copies~Sodium phenylbutyrate (NaPB): The powder form of the drug will be dispensed. The target NaPB dosing is 450-600 mg/kg/day, divided into four doses. For cohort 1, we propose to continue treatment for 18 months. For cohort 2, we propose to continue treatment for 24 months."
436272|NCT00527111|B3|Baseline|Total|Total of all reporting groups
436273|NCT00527111|B2|Baseline|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436274|NCT00527111|B1|Baseline|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436275|NCT00527111|P2|Participant Flow|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436276|NCT00527111|P1|Participant Flow|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436277|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436278|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436279|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436280|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436281|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436282|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436283|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436284|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436285|NCT00527111|O2|Outcome|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436286|NCT00527111|O1|Outcome|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436287|NCT00527111|E2|Reported Event|Chemoradiotherapy Alone|"Pelvic irradiation plus 5-fluorouracil~5-fluorouracil~Pelvic irradiation"
436288|NCT00527111|E1|Reported Event|Chemoradiotherapy Plus Cetuximab|"Pelvic irradiation plus 5-fluorouracil plus cetuximab~Cetuximab~5-fluorouracil~Pelvic irradiation"
436289|NCT00527098|B3|Baseline|Total|Total of all reporting groups
436290|NCT00527098|B2|Baseline|Standard of Care|Routine Standard of Care Resuscitation Fluid
436291|NCT00527098|B1|Baseline|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
436292|NCT00527098|P2|Participant Flow|Standard of Care|Routine Standard of Care Resuscitation Fluid
436293|NCT00527098|P1|Participant Flow|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
436294|NCT00527098|O1|Outcome|Observational|This is an observational trial.
436295|NCT00527098|E2|Reported Event|Standard of Care|Routine Standard of Care Resuscitation Fluid
436296|NCT00527098|E1|Reported Event|Hextend Plus Standard of Care|Hextend along with the routine Standard of Care Resuscitation Fluid
436297|NCT00527072|B1|Baseline|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
436298|NCT00527072|P1|Participant Flow|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
436299|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
436300|NCT00527072|O1|Outcome|Infliximab|Open-label 5 mg/kg infliximab infusions at Weeks 0, 2, 6, 14, and 22.
436301|NCT00527072|O1|Outcome|Infliximab|Open-label study, patients received IV infusions of 5 mg/kg infliximab at Weeks 0, 2, 6, 14, and 22
436306|NCT00526994|B1|Baseline|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436307|NCT00526994|P3|Participant Flow|Control|no screen and no referral
436308|NCT00526994|P2|Participant Flow|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436309|NCT00526994|P1|Participant Flow|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436310|NCT00526994|O3|Outcome|Control|no screen and no referral
436311|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436312|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436313|NCT00526994|O3|Outcome|Control|no screen and no referral
436314|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436315|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436316|NCT00526994|O3|Outcome|Control|no screen and no referral
436317|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436318|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436319|NCT00526994|O3|Outcome|Control|no screen and no referral
436320|NCT00526994|O2|Outcome|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436321|NCT00526994|O1|Outcome|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436322|NCT00526994|E3|Reported Event|Control|no screen and no referral
436323|NCT00526994|E2|Reported Event|Universal Education (All Referred)|"receives referral information~universal education : receives referral information"
436324|NCT00526994|E1|Reported Event|Screened & Referred|"Screened w/4 questions on intimate partner violence; if positive, receives referral information~screening : Asked 4 questions on current exposure to intimate partner violence; if positive, receives referral information"
436325|NCT00525915|B3|Baseline|Total|Total of all reporting groups
436326|NCT00525915|B2|Baseline|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
436327|NCT00525915|B1|Baseline|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
436328|NCT00525915|P2|Participant Flow|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
436329|NCT00525915|P1|Participant Flow|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
436330|NCT00525915|O2|Outcome|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
436331|NCT00525915|O1|Outcome|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
436332|NCT00525915|E2|Reported Event|Arm B: Pre-Op Chemo + Chemo With Radiation Treatment|Pre-Operative Chemo 5-FU 2.2 mg/m^2 IV continuous infusion over 48 hours start on day 1 and 15, and Oxaliplatin 100 mg/m^2 IV over 2 hours on day 1 and 15; followed by Surgery + Chemo with Radiation Therapy (same as Arm A)
436333|NCT00525915|E1|Reported Event|Arm A: Chemo With Radiation Treatment|For 5 weeks, Chemotherapy (Chemo) of 5-Fluorouracil (5-FU) 250 mg/m^2 intravenous (IV) over 24 hours for 5 days weekly with Oxaliplatin 40 mg/m^2 IV daily over 2 hours, and Radiation treatment every weekday; then surgery.
436334|NCT00525902|B1|Baseline|Adalimumab|
436335|NCT00525902|P1|Participant Flow|Adalimumab|
436336|NCT00525902|O1|Outcome|Adalimumab|
436337|NCT00525902|O1|Outcome|Adalimumab|
436338|NCT00525902|E1|Reported Event|Adalimumab|
436339|NCT00528112|B3|Baseline|Total|Total of all reporting groups
436340|NCT00528112|B2|Baseline|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436341|NCT00528112|B1|Baseline|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436342|NCT00528112|P2|Participant Flow|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
436343|NCT00528112|P1|Participant Flow|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
436344|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436345|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436346|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436347|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436348|NCT00528112|O1|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436349|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436350|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436351|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436352|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436353|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436354|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436355|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436356|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436357|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436358|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436359|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436360|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436361|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436362|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436363|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436364|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436365|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436366|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436367|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436368|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436369|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436370|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436371|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436372|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436373|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436374|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436375|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436376|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436377|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436378|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436379|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436380|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436381|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436382|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436383|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436384|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436385|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436386|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436387|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436388|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436389|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436390|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436391|NCT00528112|O2|Outcome|LCS16|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro
436392|NCT00528112|O1|Outcome|LCS12|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro
436393|NCT00528112|E3|Reported Event|LCS16, up to 5 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 5 years.
436394|NCT00528112|E2|Reported Event|LCS16, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 16 microg/24 h in vitro. Treatment up to 3 years.
436395|NCT00528112|E1|Reported Event|LCS12, up to 3 Years|Intrauterine levonorgestrel contraceptive system (LCS), releasing levonorgestrel (LNG) 12 microg/24 h in vitro. Treatment up to 3 years.
436396|NCT00528021|B5|Baseline|Total|Total of all reporting groups
436397|NCT00528021|B4|Baseline|Vehicle|
436398|NCT00528021|B3|Baseline|12.5% BGC20-0582|
436399|NCT00528021|B2|Baseline|10% BGC20-0582|
436400|NCT00528021|B1|Baseline|2.5% BGC20-0582|
436401|NCT00528021|P4|Participant Flow|Vehicle|
436402|NCT00528021|P3|Participant Flow|12.5% BGC20-0582|
436403|NCT00528021|P2|Participant Flow|10% BGC20-0582|
436404|NCT00528021|P1|Participant Flow|2.5% BGC20-0582|
436405|NCT00528021|O4|Outcome|Vehicle|
436406|NCT00528021|O3|Outcome|12.5% BGC20-0582|
436407|NCT00528021|O2|Outcome|10% BGC20-0582|
436408|NCT00528021|O1|Outcome|2.5% BGC20-0582|
436409|NCT00528021|E4|Reported Event|Vehicle|
436410|NCT00528021|E3|Reported Event|12.5% BGC20-0582|
436411|NCT00528021|E2|Reported Event|10% BGC20-0582|
436412|NCT00528021|E1|Reported Event|2.5% BGC20-0582|
436413|NCT00527982|B3|Baseline|Total|Total of all reporting groups
436414|NCT00527982|B2|Baseline|No Treatment|
436415|NCT00527982|B1|Baseline|Celecoxib Treatment|Celecoxib 600 mg orally daily
436416|NCT00527982|P2|Participant Flow|No Treatment|
436417|NCT00527982|P1|Participant Flow|Celecoxib Treatment|Celecoxib 600 mg orally daily
436418|NCT00527982|O2|Outcome|No Treatment|
436419|NCT00527982|O1|Outcome|Celecoxib Treatment|Celecoxib 600 mg orally daily
436420|NCT00527982|E2|Reported Event|No Treatment|
436421|NCT00527982|E1|Reported Event|Celecoxib Treatment|Celecoxib 600 mg orally daily
436422|NCT00527943|B3|Baseline|Total|Total of all reporting groups
436423|NCT00527943|B2|Baseline|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436424|NCT00527943|B1|Baseline|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436425|NCT00527943|P2|Participant Flow|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436426|NCT00527943|P1|Participant Flow|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436427|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436428|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436429|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436430|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436431|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436432|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436433|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436434|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436435|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436436|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436437|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436438|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436439|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436440|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436441|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436442|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436443|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436444|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436445|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436446|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436447|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436448|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436449|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436450|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436451|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436452|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436453|NCT00527943|O2|Outcome|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436454|NCT00527943|O1|Outcome|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436455|NCT00527943|E2|Reported Event|Vorapaxar|Loading oral dose of one 40 mg vorapaxar tablet on Day 1, then one 2.5 mg vorapaxar tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436456|NCT00527943|E1|Reported Event|Placebo|Loading oral dose of one 40 mg vorapaxar placebo tablet on Day 1, then one 2.5 mg vorapaxar placebo tablet daily, orally for at least 1 year in addition to current treatment of acute coronary syndrome, which will be continued to be administered as per current stand of care.
436457|NCT00527904|B1|Baseline|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
436458|NCT00527904|P1|Participant Flow|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
436459|NCT00527904|O1|Outcome|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
436460|NCT00527904|E1|Reported Event|PN400 (VIMOVO)|PN 400 (20 mg esomeprazole and 500 mg naproxen) dosed twice daily
436461|NCT00527878|B1|Baseline|Patients|
436462|NCT00527878|P2|Participant Flow|Ranitidine/Placebo|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive ranitidine for 12 months followed by 12 months of the ranitidine.
436463|NCT00527878|P1|Participant Flow|Placebo/Ranitidine|Ranitidine will be dosed orally at 150 mg twice daily for adults, and at 2-4 mg/kg/dose twice daily for children with a maximum dose of 150 mg twice daily. Liquid formulations will be provided for individuals unable to swallow pills. Subjects will be randomized to receive placebo for 12 months followed by 12 months of the ranitidine.
436543|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
438503|NCT00522418|B3|Baseline|Total|Total of all reporting groups
436464|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
436465|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
436466|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
436467|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
436468|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
436469|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
436470|NCT00527878|O2|Outcome|Ranitidine|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the treatment for both arms.
436471|NCT00527878|O1|Outcome|Placebo|Crossover study in which patients received one year of placebo and one year of ranitidine. This analysis will include the placebo for both arms.
436472|NCT00527878|E2|Reported Event|Ranitidine|This was a crossover study and patients received 12 months of ranitidine and 12 months of placebo, unless they terminated the study.
436473|NCT00527878|E1|Reported Event|Placebo|this was a crossover study and patients received both placebo and study drug (ranitidine), both of which for 12 months, unless they terminated the study.
436474|NCT00527826|B3|Baseline|Total|Total of all reporting groups
436475|NCT00527826|B2|Baseline|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436476|NCT00527826|B1|Baseline|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436477|NCT00527826|P2|Participant Flow|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436478|NCT00527826|P1|Participant Flow|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436479|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436480|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436481|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436482|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436483|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436484|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436485|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436486|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436487|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436488|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436489|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436490|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436491|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436492|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436493|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436494|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436495|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436496|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436497|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436498|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436544|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436499|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436500|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436501|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436502|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436503|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436504|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436505|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436506|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436507|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436508|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436509|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436510|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436511|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436512|NCT00527826|O3|Outcome|Total|Total number of participants randomized to the SFC and Sal/FP groups
436513|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436514|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436515|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436516|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436517|NCT00527826|O3|Outcome|FP 500 µg|Fluticasone propionate (FP) 500 µg BID (morning and evening) from a separate inhaler (FLUTIDE forte Diskus)
436518|NCT00527826|O2|Outcome|Sal 50 µg|Salmeterol xinafoate (Sal) 50 µg BID (morning and evening) from a separate inhaler (SEVERENT Diskus)
436519|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436520|NCT00527826|O2|Outcome|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436521|NCT00527826|O1|Outcome|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436522|NCT00527826|E2|Reported Event|Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg|Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
436523|NCT00527826|E1|Reported Event|Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg|Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
436524|NCT00527787|B3|Baseline|Total|Total of all reporting groups
436525|NCT00527787|B2|Baseline|Naproxen|Naproxen 500 mg
436526|NCT00527787|B1|Baseline|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436527|NCT00527787|P2|Participant Flow|Naproxen|Naproxen 500 mg
436528|NCT00527787|P1|Participant Flow|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436529|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436530|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436531|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436532|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436533|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436534|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436535|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436536|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436537|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436538|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436539|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436540|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436541|NCT00527787|O2|Outcome|Naproxen|Naproxen 500 mg
436542|NCT00527787|O1|Outcome|PN400 (VIMOVO)|Naproxen 500 mg/Immediate-Release Esomeprazole 20 mg
436550|NCT00527735|B3|Baseline|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who experienced clinical benefit on treatment phase without intolerable toxicity could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436551|NCT00527735|B2|Baseline|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436552|NCT00527735|B1|Baseline|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks. Participants who experienced clinical benefit on treatment phase without intolerable toxicity were allowed to continue in the maintenance phase, receiving additional ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436553|NCT00527735|P3|Participant Flow|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436554|NCT00527735|P2|Participant Flow|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436555|NCT00527735|P1|Participant Flow|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease (PD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436556|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436557|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436558|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436559|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
438830|NCT00521456|O1|Outcome|Ketorolac Solution|
436560|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436561|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436562|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436563|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436564|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436565|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436566|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436567|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436568|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (sequential). The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436569|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin (concurrent). The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes every 3 weeks as part of induction. Participants could also receive additional maintenance ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436570|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436571|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436572|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436573|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436574|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436575|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436576|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436577|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436578|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436579|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436590|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436654|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436710|NCT00527488|B1|Baseline|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436580|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436581|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436582|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436583|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436584|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436585|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436586|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436587|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436588|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436589|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436648|NCT00527618|E1|Reported Event|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
436591|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436592|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436593|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436594|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436595|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436596|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436597|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436598|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436599|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436600|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436649|NCT00527605|B3|Baseline|Total|Total of all reporting groups
436706|NCT00527488|B5|Baseline|Total|Total of all reporting groups
436601|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436602|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436603|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436604|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436605|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436606|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436607|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436608|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436609|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436610|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436650|NCT00527605|B2|Baseline|Placebo|Matching oral placebo once a day for 6 months
436611|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436612|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436613|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436614|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436615|NCT00527735|O2|Outcome|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until PD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436616|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress and did not experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436617|NCT00527735|O3|Outcome|Placebo + Paclitaxel/Carboplatin|During induction, participants received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436618|NCT00527735|O2|Outcome|Ipilimumab + Paclitaxel/Carboplatin (Sequential)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436619|NCT00527735|O1|Outcome|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent)|During induction, participants received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436620|NCT00527735|E6|Reported Event|Placebo + Paclitaxel/Carboplatin SCLC|During induction, participants with SCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436651|NCT00527605|B1|Baseline|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436652|NCT00527605|P2|Participant Flow|Placebo|Matching oral placebo once a day for 6 months
438831|NCT00521456|O2|Outcome|Vehicle Solution|
436621|NCT00527735|E5|Reported Event|Placebo/Ipilimumab + Paclitaxel/Carboplatin (Sequential) SCLC|During induction, participants with SCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until progressive disease, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436622|NCT00527735|E4|Reported Event|Ipilimumab/Placebo + Paclitaxil/Carboplatin (Concurrent) SCLC|During induction, participants with small-cell lung cancer (SCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436623|NCT00527735|E3|Reported Event|Placebo + Paclitaxel/Carboplatin NSCLC|During induction, participants with NSCLC received up to 6 doses of placebo ipilimumab with paclitaxel/carboplatin every 3 weeks. Matched placebo for ipilimumab was administered as a single dose IV over 90 minutes every 3 weeks (up to 6 doses) as part of induction. Participants who did not progress or experience intolerable toxicity during the treatment phase could continue in the maintenance phase, receiving maintenance placebo administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose.
436624|NCT00527735|E2|Reported Event|Placebo/Ipilimumab+ Paclitaxel/Carboplatin (Sequential) NSCLC|During induction, participants with NSCLC received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 2 doses consisted placebo ipilimumab with paclitaxel/carboplatin followed by 4 doses of active ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered IV as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered IV over 90 minutes every 12 weeks starting 24 weeks after the first dose until irPD, drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436625|NCT00527735|E1|Reported Event|Ipilimubab+Paclitaxel/Carboplatin (Concurrent) NSCLC|During induction, participants with nonsmall-cell lung cancer (NSCLC) received up to 6 doses of blinded ipilimumab with paclitaxel/carboplatin on a 3-week schedule. The initial 4 doses consisted of active ipilimumab with paclitaxel/carboplatin, and the last 2 doses consisted of placebo ipilimumab with paclitaxel/carboplatin. Ipilimumab, 10 mg/kg, was administered intravenously (IV) as a single dose over 90 minutes. Participants who did not progress or experience intolerable toxicity during the treatment phase were allowed to continue in the maintenance phase, receiving additional (blinded) ipilimumab at a dose of 10 mg/kg administered intravenously (IV) over 90 minutes every 12 weeks starting 24 weeks after the first dose until immune-related progressive disease (irPD), drug intolerance, withdrawal of consent, pregnancy, death, loss to follow up, or study closure.
436626|NCT00527722|B3|Baseline|Total|Total of all reporting groups
436627|NCT00527722|B2|Baseline|No Pleural Plug|The standard lung biopsy without placement of the plug.
436628|NCT00527722|B1|Baseline|Pleural Plug|Experimental lung plug after the lung biopsy.
436629|NCT00527722|P2|Participant Flow|No Pleural Plug|The standard lung biopsy without placement of the plug.
436630|NCT00527722|P1|Participant Flow|Pleural Plug|Experimental lung plug after the lung biopsy.
436631|NCT00527722|O2|Outcome|No Pleural Plug|The standard lung biopsy without placement of the plug.
436632|NCT00527722|O1|Outcome|Pleural Plug|Experimental lung plug after the lung biopsy.
436633|NCT00527722|E2|Reported Event|No Pleural Plug|The standard lung biopsy without placement of the plug.
436634|NCT00527722|E1|Reported Event|Pleural Plug|Experimental lung plug after the lung biopsy.
436635|NCT00527618|B1|Baseline|Entire Study Population|This includes all 34 participants who were randomized. A subset of 28 participants were included in the analysis since only 28 participants contributed samples on both arms of the crossover study.
436636|NCT00527618|P2|Participant Flow|Valacyclovir Followed by Acyclovir|Valacyclovir 1000 mg twice daily, followed by a two-week washout period, then acyclovir 400 mg twice daily
436637|NCT00527618|P1|Participant Flow|Acyclovir Followed by Valacyclovir|Acyclovir 400 mg twice daily, followed by a two-week washout period, then valacyclovir 1000 mg twice daily
436638|NCT00527618|O1|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily
436639|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
436640|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
436641|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
436642|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
436643|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
436644|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
436645|NCT00527618|O2|Outcome|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
436646|NCT00527618|O1|Outcome|Acyclovir|Acyclovir, 400 mg orally twice daily (assigned to the acyclovir arm in either the first or second intervention periods)
436647|NCT00527618|E2|Reported Event|Valacyclovir|Valacyclovir, 1000 mg orally twice daily (assigned to the valacyclovir arm in either the first or second intervention periods)
436707|NCT00527488|B4|Baseline|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436655|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436656|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436657|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436658|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436659|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436660|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436661|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436662|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436663|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436664|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436665|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436666|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436667|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436668|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436669|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436670|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436671|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436672|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436673|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436674|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436675|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436676|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436677|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436678|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436679|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436680|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436681|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436682|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436683|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436684|NCT00527605|O2|Outcome|Placebo|Matching oral placebo once a day for 6 months
436685|NCT00527605|O1|Outcome|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436686|NCT00527605|E2|Reported Event|Placebo|Matching oral placebo once a day for 6 months
436687|NCT00527605|E1|Reported Event|Dutasteride 0.5 mg|Oral dutasteride 0.5 milligrams (mg) once a day for 6 months
436688|NCT00527592|B1|Baseline|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
436689|NCT00527592|P1|Participant Flow|Travoprost/Latanoprost|Travoprost assigned to one eye, with latanoprost assigned to the fellow eye for intra-individual control.
436690|NCT00527592|O2|Outcome|Latanoprost|One drop in the study eye, single dose
436691|NCT00527592|O1|Outcome|Travoprost|One drop in the study eye, single dose
436692|NCT00527592|E2|Reported Event|Latanoprost|One drop in the study eye, single dose
436693|NCT00527592|E1|Reported Event|Travoprost|One drop in the study eye, single dose
436694|NCT00527514|B1|Baseline|Amlodipine and Olmesartan, if Necessary|Week 1-3 all participants: Amlodipine 5mg; Week 4-6 Amlodipine 5 mg/olmesartan 20 mg if mean SBP >= 120/80 mm Hg; Week 7-9 Amlodipine 5 mg/ olmesartan 40 mg if mean SBP >= 120/80 mm Hg; Week 10-12 Amlodipine 10 mg/olmesartan 40 mg if mean SBP >= 120/80 mm Hg
436695|NCT00527514|P1|Participant Flow|Amlodipine and Olmesartan, if Necessary|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
436696|NCT00527514|O1|Outcome|Group 4 - Aml 10 mg + Olm 40 mg|
436697|NCT00527514|O1|Outcome|Group 3 - Aml 5 mg + Olm 40 mg|Participants from Group 2 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 40mg.
436698|NCT00527514|O1|Outcome|Group 2 - Aml 5 mg + Olmesartan 20 mg|Participants from Group 1 who did not meet the blood pressure goal after 3 weeks were titrated to Aml 5 mg + olmesartan 20 mg.
436699|NCT00527514|O1|Outcome|Group 1 Amlodipine 5 mg|All participants started the Active Treatment period with 5 mg of amlodipine for 3 weeks.
436700|NCT00527514|O1|Outcome|Overall Active Treatment Period|
436701|NCT00527514|O1|Outcome|Overall Active Treatment Period|
436702|NCT00527514|E4|Reported Event|Amlodipine 10 mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
436703|NCT00527514|E3|Reported Event|Amlodipine 5mg and Olmesartan 40 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
436704|NCT00527514|E2|Reported Event|Amlodipine 5mg and Olmesartan 20 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
436705|NCT00527514|E1|Reported Event|Amlodipine 5 mg|All eligible participants began the active treatment period with amlodipine (Aml) 5 mg for Weeks 1-3. If blood pressure was greater than 120/80 at the end of 3 weeks, participants were titrated to the next regimen for weeks 4-6, and so on for weeks 7-9 and 10-12.
436711|NCT00527488|P4|Participant Flow|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436712|NCT00527488|P3|Participant Flow|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436713|NCT00527488|P2|Participant Flow|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436714|NCT00527488|P1|Participant Flow|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436715|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436716|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436717|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436718|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436719|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436720|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436721|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436722|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436723|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436724|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436725|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436726|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436727|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436728|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436729|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436730|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436731|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436732|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436733|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436734|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436735|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436736|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436737|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436738|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436739|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436740|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436741|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436742|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436743|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436744|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436745|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436746|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436747|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436748|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436749|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436750|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436751|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436752|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436753|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436754|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436755|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436756|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436757|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436758|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436759|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436760|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436761|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436762|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436763|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436764|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436765|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436766|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436767|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436768|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436769|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436770|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436771|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436772|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436773|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436774|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436775|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436776|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436777|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
438832|NCT00521456|O1|Outcome|Ketorolac Solution|
436778|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436779|NCT00527488|O4|Outcome|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436780|NCT00527488|O3|Outcome|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436781|NCT00527488|O2|Outcome|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436782|NCT00527488|O1|Outcome|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436783|NCT00527488|E4|Reported Event|Degarelix 64 mg|A single dose of Degarelix 64 mg on Day 0
436784|NCT00527488|E3|Reported Event|Degarelix 32+32 mg|Two doses of Degarelix 32 mg on Day 0 and Day 14
436785|NCT00527488|E2|Reported Event|Degarelix 32 mg|A single dose of Degarelix 32 mg on Day 0
436786|NCT00527488|E1|Reported Event|Degarelix 16+16 mg|Two doses of Degarelix 16 mg on Day 0 and Day 14
436787|NCT00527475|B3|Baseline|Total|Total of all reporting groups
436788|NCT00527475|B2|Baseline|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
436789|NCT00527475|B1|Baseline|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
436790|NCT00527475|P2|Participant Flow|Reduced Fluence PDT & Ranibizumab|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
436791|NCT00527475|P1|Participant Flow|Ranibizumab|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
436792|NCT00527475|O2|Outcome|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
436793|NCT00527475|O1|Outcome|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
436794|NCT00527475|E2|Reported Event|Group II|Group II will receive Reduced Fluence-PDT (25 Joules) followed by 0.5 mg. of ranibizumab intraocularly on the same day. The second group will receive the combination of ranibizumab and RF-PDT as needed over a period of one year.
436795|NCT00527475|E1|Reported Event|Group I|Group I will receive 0.5 mg. ranibizumab intraocularly initially. This will be repeated monthly for 3 months total and then as needed over the period of one year.
436796|NCT00527423|B1|Baseline|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
436797|NCT00527423|P1|Participant Flow|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
436798|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
436799|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|The study consisted of a treatment period from day 1 to week 152 (end of treatment), and a 4-week follow-up visit at week 156 (end of study). Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or
436800|NCT00527423|O1|Outcome|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
436801|NCT00527423|E1|Reported Event|Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) 2mg|"The study consisted of a treatment period from day 1 to week 152, and a 4-week follow-up visit at week 156. Participants were scheduled to return to the clinical site every 8 weeks. At each visit, the investigator determined the need for an Intravitreal Aflibercept Injection (EYLEA, VEGF Trap-Eye) based on his/her assessment of the participant (PRN or as needed dosing). If, at any point during the study, in the investigator's opinion, a participant required dosing or evaluation more frequently than every 8 weeks, monthly visits and dosing were permitted. The maximum frequency of injection into the study eye was every 4 weeks."
436802|NCT00527397|B1|Baseline|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
436857|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436858|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436803|NCT00527397|P1|Participant Flow|All Subjects With Type 1 or Type 2 Diabetes Mellitus|All subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
436804|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436805|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436806|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436807|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436808|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436809|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436810|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
436811|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
436812|NCT00527397|O1|Outcome|All Subjects|subjects treated with inhaled insulin
436813|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436814|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436815|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436816|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436817|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436818|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436819|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436820|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436821|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436822|NCT00527397|O3|Outcome|Type 2 Diabetes Mellitus Not Using Insulin|subjects with type 2 diabetes mellitus who had not yet treated by Insulin
436823|NCT00527397|O2|Outcome|Type 2 Diabetes Mellitus Using Insulin|subjects with type 2 diabetes mellitus who had already treated by Insulin
436824|NCT00527397|O1|Outcome|Type 1 Diabetes Mellitus|subjects with type 1 diabetes mellitus
436825|NCT00527397|E1|Reported Event|All Subjects With Type 1 or Type 2 Diabetes Mellitus|all subjects with type 1 or type 2 diabetes mellitus treated with inhaled insulin in this study. This study was open-label, uncontrolled study and at all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times.
436826|NCT00527332|B3|Baseline|Total|Total of all reporting groups
436827|NCT00527332|B2|Baseline|General Anesthesia|General anesthesia
436828|NCT00527332|B1|Baseline|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
436829|NCT00527332|P2|Participant Flow|General Anesthesia|General anesthesia
436830|NCT00527332|P1|Participant Flow|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
436831|NCT00527332|O2|Outcome|General Anesthesia|General anesthesia. General anesthesia induced with propofol, fentanyl and rocuronium, and maintained with propofol and oxygen in air. Rocuronium and fentanyl repeated when needed.
436832|NCT00527332|O1|Outcome|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine. Spinal anesthesia applied in intervertebral space L3/L4 or L2/L3 with hyperbaric bupivacaine 20 mg and morphine 0.2 mg intrathecally. Sedation with propofol.
436833|NCT00527332|E2|Reported Event|General Anesthesia|General anesthesia
436834|NCT00527332|E1|Reported Event|Spinal Anesthesia|Spinal anesthesia combined with intrathecal morphine
436835|NCT00527319|B4|Baseline|Total|Total of all reporting groups
436836|NCT00527319|B3|Baseline|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
436837|NCT00527319|B2|Baseline|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
436838|NCT00527319|B1|Baseline|Group A, Control Group|Supportive care only
436839|NCT00527319|P3|Participant Flow|Group C, High Dose VT-122|VT-122 high dose Supportive care
436840|NCT00527319|P2|Participant Flow|Group B, Low Dose VT-122|VT-122 low dose Supportive care
436841|NCT00527319|P1|Participant Flow|Group A, Control Group|Supportive care only
436842|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
436843|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
436844|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
436845|NCT00527319|O3|Outcome|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
436846|NCT00527319|O2|Outcome|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
436847|NCT00527319|O1|Outcome|Group A, Control Group|Supportive care only
436848|NCT00527319|E3|Reported Event|Group C, High Dose VT-122|VT-122 (dose of etodolac: 800 mg/day) + supportive care
436849|NCT00527319|E2|Reported Event|Group B, Low Dose VT-122|VT-122 (dose of etodolac: 400 mg/day) + supportive care
436850|NCT00527319|E1|Reported Event|Group A, Control Group|Supportive care only
436851|NCT00526890|B1|Baseline|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436852|NCT00526890|P1|Participant Flow|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436853|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436854|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436855|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436856|NCT00526890|O1|Outcome|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436859|NCT00526890|E1|Reported Event|CPSR|Concurrent Carboplatin, Paclitaxel and Selenomethionine in Combination with Radiation
436860|NCT00526799|B3|Baseline|Total|Total of all reporting groups
436861|NCT00526799|B2|Baseline|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
436862|NCT00526799|B1|Baseline|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
436863|NCT00526799|P2|Participant Flow|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
436864|NCT00526799|P1|Participant Flow|Phase I|"Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
436865|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
436866|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
436867|NCT00526799|O1|Outcome|Phase I & II|"Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily during phase II.~During phase I:~Topotecan 3.5 mg/m^2 + Sorafenib assigned dose level:~Sorafenib Dose level -1=200 mg po daily Sorafenib Dose level 1=400 mg po daily Sorafenib Dose level 2=400 mag po bid"
436868|NCT00526799|O1|Outcome|Phase II|Topotecan 3.5 mg/m^2 + Sorafenib 400 mg po daily.
436869|NCT00526799|O1|Outcome|Phase I Participants|Phase I Participants evaluable for MTD
436870|NCT00526799|E1|Reported Event|Phase I/Phase II|All Phase I/Phase II participants
436871|NCT00526669|B1|Baseline|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436872|NCT00526669|P2|Participant Flow|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436873|NCT00526669|P1|Participant Flow|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
436874|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436875|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436876|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436877|NCT00526669|O1|Outcome|Overall Study Arm|
436878|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436879|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436880|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436881|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436882|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436937|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436938|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436883|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436884|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436885|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436886|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436887|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436888|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436889|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436890|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436891|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436892|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436893|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436894|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436895|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436896|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436939|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
437106|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
438833|NCT00521456|O2|Outcome|Vehicle Solution|
436897|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436898|NCT00526669|O1|Outcome|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436899|NCT00526669|O1|Outcome|Lapatinib|Lapatinib 250 milligram (mg) tablets administered at a dose of 1250 mg once daily (OD) for 7 days
436900|NCT00526669|E1|Reported Event|Lapatinib + Capecitabine|Lapatinib tablets were administered orally at a dose of 1250 mg OD and capecitabine tablets were administered orally at a dose of 1000 milligrams per meters squared (mg/m^2) twice daily (BID) for the first 14 days of each subsequent 21-day cycle. The capecitabine dose schedule was an intermittent regimen consisting of 2 weeks of treatment followed by 1 week of rest (drug-free period). Capecitabine and lapatinib were taken at two different times of the day.
436901|NCT00526630|B1|Baseline|All Participants|Participants were randomized to receive both MPD and placebo.
436902|NCT00526630|P2|Participant Flow|Placebo Then MPD|First group treated with placebo then MPD
436903|NCT00526630|P1|Participant Flow|MPD Then Placebo|First group treated with MPD then placebo
436904|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436905|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436906|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436907|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436908|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436909|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436910|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436911|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436912|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436913|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436914|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436915|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436916|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436917|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436918|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436919|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436920|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436921|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436922|NCT00526630|O3|Outcome|Baseline|All participants with baseline data
436923|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436924|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436925|NCT00526630|O3|Outcome|Baseline|Baseline gait composite scores
436926|NCT00526630|O2|Outcome|2. Placebo|Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.
436927|NCT00526630|O1|Outcome|1. MPD|Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.
436928|NCT00526630|E2|Reported Event|2. Placebo|"Randomized to receive placebo first. At cross-over, participants will receive the active Methylphenidate.~Placebo: Participants will be given placebo instead of active MPD."
436929|NCT00526630|E1|Reported Event|1. MPD|"Randomized to receive active Methylphenidate first. At cross-over, participants will receive placebo.~Methylphenidate (MPD): Participants will be given 1 mg/kg of MPD divided in three doses (at 8 am, 12 noon, and 4 pm). A four-week titration period will be used, using 0.25-mg/kg increments per week until achieving the weight-adjusted target dosage, which may range from five to eight 10-mg tablets per day. The maximum daily dose will be 80 mg/day."
436930|NCT00526474|B3|Baseline|Total|Total of all reporting groups
436931|NCT00526474|B2|Baseline|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436932|NCT00526474|B1|Baseline|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436933|NCT00526474|P2|Participant Flow|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436934|NCT00526474|P1|Participant Flow|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436935|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436936|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436940|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436941|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436942|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436943|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436944|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436945|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436946|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436947|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436948|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436949|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436950|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436951|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436952|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436953|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436954|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436955|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436956|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436957|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436958|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436959|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436960|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436961|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436962|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436963|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436964|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436965|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436966|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436967|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436968|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436969|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
437099|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437100|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
436970|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436971|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436972|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436973|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436974|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436975|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436976|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436977|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436978|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436979|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436980|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436981|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436982|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436983|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436984|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436985|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436986|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436987|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436988|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436989|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436990|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436991|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436992|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436993|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436994|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436995|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436996|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436997|NCT00526474|O2|Outcome|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436998|NCT00526474|O1|Outcome|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
436999|NCT00526474|E2|Reported Event|Vorapaxar|one 2.5 mg tablet daily, orally, for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
437101|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437102|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437000|NCT00526474|E1|Reported Event|Placebo|1 placebo tablet, orally, daily for at least 1 year in addition to current treatment of atherosclerotic disease, which will be continued to be administered as per current standard of care.
437001|NCT00526331|B1|Baseline|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
437002|NCT00526331|P1|Participant Flow|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
437003|NCT00526331|O1|Outcome|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
437004|NCT00526331|E1|Reported Event|Overall Study|Study Group: FloTrac Sensor + Vigileo Monitor used to decide how much fluid to give during surgery; and Control Group: FloTrac Sensor + Vigileo Monitor only used for data collection during surgery while Standard of Care used to decide fluid amount.
437005|NCT00526292|B1|Baseline|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
437006|NCT00526292|P1|Participant Flow|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
437007|NCT00526292|O1|Outcome|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
437008|NCT00526292|E1|Reported Event|HLA Haploidentical Natural Killer Cell Infusion|HLA Haploidentical Natural Killer Cell Infusion for Treatment of Relapsed or Persistent Leukemia
437009|NCT00526227|B1|Baseline|1|
437010|NCT00526227|P1|Participant Flow|1|
437011|NCT00526227|O1|Outcome|1|
437012|NCT00526227|O1|Outcome|1|
437013|NCT00526227|O1|Outcome|1|
437014|NCT00526188|B1|Baseline|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437015|NCT00526188|P1|Participant Flow|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437016|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437017|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437018|NCT00526188|O1|Outcome|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437019|NCT00526188|E1|Reported Event|Gadoxetic Acid Disodium (Primovist, BAY86-4873)|Bolus injection of 0.025 mmol/kg body weight (0.1 ml/kg BW) of Gadoxetic Acid Disodium (Primovist, BAY86-4873). Single i.v. injection during MRI procedure, with one contrast-enhanced MRI procedure per patient
437020|NCT00526162|B1|Baseline|1|
437021|NCT00526162|P1|Participant Flow|1|
437022|NCT00526162|O1|Outcome|1|
437023|NCT00526162|O1|Outcome|1|
437024|NCT00526162|O1|Outcome|1|
437025|NCT00526123|B3|Baseline|Total|Total of all reporting groups
437026|NCT00526123|B2|Baseline|Split-tip|split-tip hemodialysis catheter
437027|NCT00526123|B1|Baseline|Symmetric Tip|symmetric tip hemodialysis catheter
437028|NCT00526123|P2|Participant Flow|Split-tip|split-tip hemodialysis catheter
437029|NCT00526123|P1|Participant Flow|Symmetric Tip|symmetric tip hemodialysis catheter
437030|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437031|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437032|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437033|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437034|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437035|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437036|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437037|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437038|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437039|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437040|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437041|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437042|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437043|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437044|NCT00526123|O2|Outcome|Split-tip|split-tip hemodialysis catheter
437045|NCT00526123|O1|Outcome|Symmetric Tip|symmetric tip hemodialysis catheter
437046|NCT00526123|E2|Reported Event|Split-tip|split-tip hemodialysis catheter
437047|NCT00526123|E1|Reported Event|Symmetric Tip|symmetric tip hemodialysis catheter
437048|NCT00526110|B3|Baseline|Total|Total of all reporting groups
437049|NCT00526110|B2|Baseline|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437103|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437104|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437105|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437050|NCT00526110|B1|Baseline|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437051|NCT00526110|P2|Participant Flow|Phase II: Docetaxel MTD 50 mg/m^2|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437052|NCT00526110|P1|Participant Flow|Phase I: Dose Escalation|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437053|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437054|NCT00526110|O1|Outcome|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437055|NCT00526110|O1|Outcome|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437056|NCT00526110|E2|Reported Event|Phase II|Phase II: Docetaxel 50 mg/m^2 IV over 60 minutes. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437057|NCT00526110|E1|Reported Event|Phase I|Phase I: Starting dose of 20mg/m^2 IV Docetaxel over 60 minutes. Dose escalation of Docetaxel in 2.5 mg/m^2 increments until the maximum tolerated dose is determined. 5-Fluorouracil by continuous infusion pump at a dose of 2.2 g/m^2 over 48 hours on Day 1. Oxaliplatin 85 mg/m^2 IV over 120 minutes on Day 1. Treatment was repeated every 14 days (one cycle = 28 days or two 14-day treatments).
437058|NCT00526097|B3|Baseline|Total|Total of all reporting groups
437059|NCT00526097|B2|Baseline|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437060|NCT00526097|B1|Baseline|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437061|NCT00526097|P2|Participant Flow|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437062|NCT00526097|P1|Participant Flow|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437063|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437064|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437065|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437066|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437067|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437068|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437069|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437070|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437071|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437072|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437073|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437074|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437075|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437076|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437077|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437078|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437079|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437080|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437081|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437082|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437083|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437084|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437085|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437086|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437087|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437088|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437089|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437090|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437091|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437092|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437093|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437094|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437095|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437096|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437097|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437098|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437107|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437108|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437109|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437110|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437111|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437112|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437113|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437114|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437115|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437116|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437117|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437118|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437119|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437120|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437121|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437122|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437123|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437124|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437125|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437126|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437127|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437128|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437129|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437130|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437131|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437132|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437133|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437134|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437135|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437136|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437137|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437138|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437139|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437140|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437141|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437142|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437143|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437144|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437145|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437146|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437147|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437148|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437149|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437150|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437151|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437152|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437153|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437154|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437155|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437156|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437157|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437158|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437159|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437160|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437161|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437162|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437163|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437164|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437165|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437166|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437167|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437168|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437169|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437170|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437171|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437172|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437173|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437174|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437175|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437176|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437177|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437178|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437179|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437180|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437181|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437182|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437183|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437184|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437185|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437186|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437187|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437188|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437189|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437190|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437191|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437192|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437193|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437194|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437195|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437196|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437197|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437198|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437199|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437200|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437201|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437202|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437203|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437204|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437205|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437206|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437207|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437208|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437209|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437210|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437211|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437212|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437213|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437214|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437215|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437216|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437217|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437218|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437219|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437220|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437221|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437222|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437223|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437224|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437225|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437226|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437227|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437228|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437229|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437230|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437231|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437232|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437233|NCT00526097|O2|Outcome|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437234|NCT00526097|O1|Outcome|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437235|NCT00526097|E2|Reported Event|Bisacodyl|Two bisacodyl 5 mg tablets once daily
437236|NCT00526097|E1|Reported Event|Placebo|Two bisacodyl-matching 5 mg placebo tablets once daily
437237|NCT00526058|B3|Baseline|Total|Total of all reporting groups
437238|NCT00526058|B2|Baseline|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
437239|NCT00526058|B1|Baseline|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
437240|NCT00526058|P2|Participant Flow|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
437241|NCT00526058|P1|Participant Flow|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
437242|NCT00526058|O2|Outcome|Futura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
437243|NCT00526058|O1|Outcome|Secura|Data for all 18 subjects; regardless of treatment sequence (Secura-Futura or Futura-Secura)
437244|NCT00526058|E2|Reported Event|Futura|Randomized first to the approved Plasmat® Futura apheresis system then Plasmat® Secura apheresis system.
437245|NCT00526058|E1|Reported Event|Secura|Randomized first to the approved Plasmat® Secura apheresis system then Plasmat® Futura apheresis system.
437246|NCT00525876|B3|Baseline|Total|Total of all reporting groups
437247|NCT00525876|B2|Baseline|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
437248|NCT00525876|B1|Baseline|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
437249|NCT00525876|P2|Participant Flow|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
437250|NCT00525876|P1|Participant Flow|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
437251|NCT00525876|O2|Outcome|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
437252|NCT00525876|O1|Outcome|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
437253|NCT00525876|E2|Reported Event|Allo MUD & MM|Allo MUD & MM = Allogeneic Stem Cell Transplantation, Matched unrelated donor or mismatched sibling donor transplantations: Cyclophosphamide 1000 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -8, -1 before transplantation and Days 6, 13 after transplantation. Alemtuzumab 15 mg per day given intravenously days 1 through 3 after transplantation.
437254|NCT00525876|E1|Reported Event|Matched Sibling Transplant|Allogeneic Stem Cell Transplantation With Rituximab Containing Nonablative Conditioning Regimen: Cyclophosphamide 750 mg/m^2 given intravenously on Day -3, 4 hours after completion of Fludarabine 30 mg/m^2 given intravenously on Days -5 and -3 before transplantation. Rituximab 375 mg/m^2 given intravenously on Days -13, -6 before transplantation and Days 16, 8 after transplantation.
437255|NCT00525837|B1|Baseline|Varenicline|
437256|NCT00525837|P1|Participant Flow|Varenicline|
437257|NCT00525837|O1|Outcome|Varenicline|
437258|NCT00525837|E1|Reported Event|Varenicline|
437259|NCT00525824|B5|Baseline|Total|Total of all reporting groups
437260|NCT00525824|B4|Baseline|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437261|NCT00525824|B3|Baseline|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437262|NCT00525824|B2|Baseline|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437263|NCT00525824|B1|Baseline|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437264|NCT00525824|P4|Participant Flow|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437265|NCT00525824|P3|Participant Flow|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437266|NCT00525824|P2|Participant Flow|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437267|NCT00525824|P1|Participant Flow|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437268|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437269|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437270|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437271|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437272|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437273|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437274|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437275|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437276|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437277|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437278|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437279|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437280|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437281|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437282|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437283|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437284|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437285|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437286|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437287|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437288|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437289|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437290|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437291|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437292|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437293|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437294|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437295|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437296|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437297|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437298|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437299|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437300|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437301|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437302|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437303|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437304|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437305|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437306|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437307|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437308|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437309|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437310|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437311|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437312|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437313|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437314|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437315|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437316|NCT00525824|O4|Outcome|S80 to S80 + E10|Simvastatin 80 mg followed by Simvastatin 80 mg + Ezetimibe 10 mg
437317|NCT00525824|O3|Outcome|S40 to S40 + E10|Simvastatin 40 mg followed by Simvastatin 40 mg + Ezetimibe 10 mg
437318|NCT00525824|O2|Outcome|R20 to R20 + E10|Rosuvastatin 20 mg followed by Rosuvastatin 20 mg + Ezetimibe 10 mg
437319|NCT00525824|O1|Outcome|R10 to R10 + E10|Rosuvastatin 10 mg followed by Rosuvastatin 10 mg + Ezetimibe 10 mg
437320|NCT00525824|E8|Reported Event|Simva 80 mg + Eze 10 mg|Simvastatin 80 mg + Ezetimibe 10 mg
437321|NCT00525824|E7|Reported Event|Simva 40 mg + Eze 10 mg|Simvastatin 40 mg + Ezetimibe 10 mg
437322|NCT00525824|E6|Reported Event|Rosu 20 mg + Eze 10 mg|Rosuvastatin 20 mg + Ezetimibe 10 mg
437323|NCT00525824|E5|Reported Event|Rosu 10 mg + Eze 10 mg|Rosuvastatin 10 mg + Ezetimibe 10 mg
437324|NCT00525824|E4|Reported Event|Simvastatin 80 mg|Simvastatin 80 mg Monotherapy arm
437325|NCT00525824|E3|Reported Event|Simvastatin 40 mg|Simvastatin 40 mg Monotherapy arm
437326|NCT00525824|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg Monotherapy arm
437327|NCT00525824|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg Monotherapy arm
437328|NCT00525798|B3|Baseline|Total|Total of all reporting groups
437329|NCT00525798|B2|Baseline|Placebo|1 tablet of placebo daily
437330|NCT00525798|B1|Baseline|SMC021|1 tablet of 0,80 mg SMC021 daily
437331|NCT00525798|P2|Participant Flow|Placebo|1 tablet of placebo daily
437332|NCT00525798|P1|Participant Flow|SMC021|1 tablet of 0,80 mg SMC021 daily
437333|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
437334|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
437335|NCT00525798|O2|Outcome|Placebo|1 tablet of placebo daily
437336|NCT00525798|O1|Outcome|SMC021|1 tablet of 0,80 mg SMC021 daily
437337|NCT00525798|E2|Reported Event|Placebo|1 tablet of placebo daily
437338|NCT00525798|E1|Reported Event|SMC021|1 tablet of 0,80 mg SMC021 daily
437339|NCT00525733|B3|Baseline|Total|Total of all reporting groups
437358|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
438834|NCT00521456|O1|Outcome|Ketorolac Solution|
437340|NCT00525733|B2|Baseline|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
437341|NCT00525733|B1|Baseline|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
437342|NCT00525733|P2|Participant Flow|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
437343|NCT00525733|P1|Participant Flow|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
437344|NCT00525733|O2|Outcome|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
437345|NCT00525733|O1|Outcome|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
437346|NCT00525733|E2|Reported Event|5-drug Experimental Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD + Raltegravir 400 mg BID + Maraviroc 150 mg BID~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)~Maraviroc: Maraviroc will be administered twice daily in 150 mg tablets (may be taken with or without food)~Raltegravir: Raltegravir will be administered twice daily as 1-400 mg tablets (to be taken with food)"
437347|NCT00525733|E1|Reported Event|3-drug Standard Therapy|"FTC 200 mg/TDF 300 mg QD + darunavir 800 mg/ritonavir 100 mg QD~darunavir: Darunavir 800mg tablet will be administered with 100 mg capsule of ritonavir once daily (may be taken with or without food)~Emtricitabine/tenofovir DF: Emtricitabine/tenofovir DF fixed-dose tablet containing 200 mg of emtricitabine and 300 mg of tenofovir DF will be administered orally as one tablet once daily (may be taken with or without food)"
437348|NCT00525603|B1|Baseline|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
437349|NCT00525603|P1|Participant Flow|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
437350|NCT00525603|O1|Outcome|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
437351|NCT00525603|E1|Reported Event|CFAR|Participants received fludarabine 20 mg/m^2 days 3-5 intravenous (IV), cyclophosphamide 200 mg/m^2 days 3-5 IV, Alemtuzumab 30 mg IV days 1, 3 and 5, and rituximab 375 mg/m^2 IV on day 2 for C1 and 500mg/m^2 IV on day 2 for C2-6.
437352|NCT00525525|B3|Baseline|Total|Total of all reporting groups
437353|NCT00525525|B2|Baseline|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
437354|NCT00525525|B1|Baseline|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
437355|NCT00525525|P2|Participant Flow|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
437356|NCT00525525|P1|Participant Flow|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
437357|NCT00525525|O1|Outcome|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
437359|NCT00525525|O1|Outcome|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
437360|NCT00525525|E2|Reported Event|Safety Lead-in Group|A safety lead-in group received bevacizumab and erlotinib added to TMZ after completion of radiation to rule out unexpected toxicity of the combination of drugs.
437361|NCT00525525|E1|Reported Event|Efficacy Group|Patients treated with the combination of radiation plus temozolomide (75 mg/m2 daily during radiotherapy) plus bevacizumab (10 mg/kg IV every two weeks during radiotherapy) plus tarceva (dose based upon use of EIAED, either 200 mg daily or 500 mg daily; given daily); all treatment begins at the start of radiotherapy and continues until tumor progression, death or excessive toxicity
437362|NCT00525512|B3|Baseline|Total|Total of all reporting groups
437363|NCT00525512|B2|Baseline|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437364|NCT00525512|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
437365|NCT00525512|P4|Participant Flow|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437366|NCT00525512|P3|Participant Flow|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437367|NCT00525512|P2|Participant Flow|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437368|NCT00525512|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
437369|NCT00525512|O4|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437370|NCT00525512|O3|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437371|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437372|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437373|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437374|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437375|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437376|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437377|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437378|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437379|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437380|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437381|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437382|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437383|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437384|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437385|NCT00525512|O2|Outcome|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437386|NCT00525512|O1|Outcome|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437387|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437388|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437389|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437390|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437391|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437392|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437393|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437394|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437395|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437396|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437397|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437398|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437399|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437400|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437401|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437402|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437403|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437404|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437405|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437406|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437407|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437408|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437409|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437410|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437411|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437412|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437413|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437414|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437415|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437416|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437417|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437418|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437419|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437420|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437421|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437422|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437423|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437424|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437425|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437426|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437427|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437428|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437429|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437430|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437431|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437432|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437433|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437434|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437435|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437436|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437437|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437438|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437439|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437440|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437441|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437442|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437443|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437444|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437445|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437446|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437447|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437448|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437449|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437450|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437451|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437452|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437453|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437454|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437455|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437456|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437457|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437458|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437459|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437460|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437461|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437462|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437463|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437464|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437465|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437466|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437467|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437468|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437469|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437470|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437471|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437472|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437473|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
438835|NCT00521456|O2|Outcome|Vehicle Solution|
437474|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437475|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437476|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437477|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437478|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437479|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437480|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437481|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437482|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437483|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437484|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437485|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437486|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437487|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437488|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437489|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437490|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437491|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437492|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437493|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437494|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437495|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437496|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437497|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437498|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437499|NCT00525512|O2|Outcome|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437500|NCT00525512|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
437501|NCT00525512|E4|Reported Event|Tiotropium / Open Tiotropium|Patients receive open label tiotropium following tiotropium
437502|NCT00525512|E3|Reported Event|Placebo / Open Tiotropium|Patients receive open label tiotropium following placebo
437503|NCT00525512|E2|Reported Event|Tiotropium|Patients randomized to treatment with Tiotropium 18 micrograms
437504|NCT00525512|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
437505|NCT00525499|B5|Baseline|Total|Total of all reporting groups
437506|NCT00525499|B4|Baseline|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437507|NCT00525499|B3|Baseline|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437508|NCT00525499|B2|Baseline|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437509|NCT00525499|B1|Baseline|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
437510|NCT00525499|P4|Participant Flow|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437511|NCT00525499|P3|Participant Flow|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437512|NCT00525499|P2|Participant Flow|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437513|NCT00525499|P1|Participant Flow|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
437514|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437515|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437516|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437517|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
437518|NCT00525499|O4|Outcome|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437519|NCT00525499|O3|Outcome|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437520|NCT00525499|O2|Outcome|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437521|NCT00525499|O1|Outcome|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
437522|NCT00525499|E4|Reported Event|0.025% ASC-J9 Cream|0.025% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437523|NCT00525499|E3|Reported Event|0.005% ASC-J9 Cream|0.005% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437524|NCT00525499|E2|Reported Event|0.001% ASC-J9 Cream|0.001% ASC-J9 cream applied topically to the face twice daily for 12 weeks
437525|NCT00525499|E1|Reported Event|Vehicle Control|Vehicle control cream applied topically to the face twice daily for 12 weeks
437526|NCT00525421|B3|Baseline|Total|Total of all reporting groups
437527|NCT00525421|B2|Baseline|Placebo|Placebo : identical placebo tablets three times per day for 12 days
437528|NCT00525421|B1|Baseline|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
437529|NCT00525421|P2|Participant Flow|Placebo|Placebo : identical placebo tablets three times per day for 12 days
437530|NCT00525421|P1|Participant Flow|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
438836|NCT00521456|O1|Outcome|Ketorolac Solution|
437531|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
437532|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
437533|NCT00525421|O2|Outcome|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
437534|NCT00525421|O1|Outcome|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
437535|NCT00525421|E2|Reported Event|Placebo|Placebo: Identical placebo tablets three times per day for 12 days
437536|NCT00525421|E1|Reported Event|Curcuminoid|Curcuminoids : Curcuminoids tablets 2000mg three times per day for 12 days
437537|NCT00525265|B3|Baseline|Total|Total of all reporting groups
437538|NCT00525265|B2|Baseline|OPC-41061 15 mg|OPC-41061 15 mg/day
437539|NCT00525265|B1|Baseline|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
437540|NCT00525265|P2|Participant Flow|OPC-41061 15 mg|OPC-41061 1.5 mg/day
437541|NCT00525265|P1|Participant Flow|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
437542|NCT00525265|O2|Outcome|OPC-41061 15 mg|OPC-41061 15 mg/day
437543|NCT00525265|O1|Outcome|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
437544|NCT00525265|E2|Reported Event|OPC-41061 15 mg|OPC-41061 15 mg/day
437545|NCT00525265|E1|Reported Event|OPC-41061 7.5 mg|OPC-41061 7.5 mg/day
437546|NCT00525174|B3|Baseline|Total|Total of all reporting groups
437547|NCT00525174|B2|Baseline|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
437548|NCT00525174|B1|Baseline|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
437549|NCT00525174|P2|Participant Flow|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
437550|NCT00525174|P1|Participant Flow|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
437551|NCT00525174|O2|Outcome|Patching|
437552|NCT00525174|O1|Outcome|Bangerter|
437553|NCT00525174|O2|Outcome|Patching|
437554|NCT00525174|O1|Outcome|Bangerter|
437555|NCT00525174|O2|Outcome|Patching|
437556|NCT00525174|O1|Outcome|Bangerter|
437557|NCT00525174|O2|Outcome|Patching|
437558|NCT00525174|O1|Outcome|Bangerter|
437559|NCT00525174|O2|Outcome|Patching|
437560|NCT00525174|O1|Outcome|Bangerter|
437561|NCT00525174|O2|Outcome|Patching|
437562|NCT00525174|O1|Outcome|Bangerter|
437563|NCT00525174|O2|Outcome|Patching|
437564|NCT00525174|O1|Outcome|Bangerter|
437565|NCT00525174|O2|Outcome|Patching|
437566|NCT00525174|O1|Outcome|Bangerter|
437567|NCT00525174|O2|Outcome|Patching|
437568|NCT00525174|O1|Outcome|Bangerter|
437569|NCT00525174|O2|Outcome|Patching|
437570|NCT00525174|O1|Outcome|Bangerter|
437571|NCT00525174|O2|Outcome|Patching|
437572|NCT00525174|O1|Outcome|Bangerter|
437573|NCT00525174|O2|Outcome|Patching|
437574|NCT00525174|O1|Outcome|Bangerter|
437575|NCT00525174|O2|Outcome|Patching|
437576|NCT00525174|O1|Outcome|Bangerter|
437577|NCT00525174|O2|Outcome|Patching|
437578|NCT00525174|O1|Outcome|Bangerter|
437579|NCT00525174|O2|Outcome|Patching|
437580|NCT00525174|O1|Outcome|Bangerter|
437581|NCT00525174|O2|Outcome|Patching|
437582|NCT00525174|O1|Outcome|Bangerter|
437583|NCT00525174|O2|Outcome|Patching|
437584|NCT00525174|O1|Outcome|Bangerter|
437585|NCT00525174|O2|Outcome|Patching|
437586|NCT00525174|O1|Outcome|Bangerter|
437587|NCT00525174|O2|Outcome|Patching|
437588|NCT00525174|O1|Outcome|Bangerter|
437589|NCT00525174|O2|Outcome|Patching|
437590|NCT00525174|O1|Outcome|Bangerter|
437591|NCT00525174|O2|Outcome|Patching|
437592|NCT00525174|O1|Outcome|Bangerter|
437593|NCT00525174|O2|Outcome|Patching|
437594|NCT00525174|O1|Outcome|Bangerter|
437595|NCT00525174|E2|Reported Event|Bangerter Filters|Bangerter filter worn on sound eye spectacles lens full time plus at least one hour near activities
437596|NCT00525174|E1|Reported Event|Patching|2 hours daily patching of the sound eye plus one hour near activities while patching
437597|NCT00525161|B1|Baseline|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437598|NCT00525161|P1|Participant Flow|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437599|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437600|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437601|NCT00525161|O1|Outcome|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437602|NCT00525161|E1|Reported Event|Sorafenib & Endocrine Therapy|"Sorafenib & Endocrine Therapy~sorafenib: 400 mg PO (orally) twice daily for 12 months from study enrollment or until disease progression, whichever occurs first."
437603|NCT00525148|B5|Baseline|Total|Total of all reporting groups
437604|NCT00525148|B4|Baseline|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
437605|NCT00525148|B3|Baseline|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
437635|NCT00525135|E1|Reported Event|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437606|NCT00525148|B2|Baseline|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
437607|NCT00525148|B1|Baseline|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
437608|NCT00525148|P4|Participant Flow|Second-line Afatinib 50 mg|Second-line patients received a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
437609|NCT00525148|P3|Participant Flow|Second-line Afatinib 40 mg|Second-line patients received a starting oral dose of Afatinib 40 mg daily only after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
437610|NCT00525148|P2|Participant Flow|First-line Afatinib 50 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 50 mg daily. Dose reduction scheme was defined for patients unable to tolerate this dose.
437611|NCT00525148|P1|Participant Flow|First-line Afatinib 40 mg|First-line patients were enrolled after Amendment 1 with a starting oral dose of Afatinib 40 mg daily after Amendment 2. Dose reduction scheme was defined for patients unable to tolerate this dose.
437612|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
437613|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
437614|NCT00525148|O2|Outcome|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
437615|NCT00525148|O1|Outcome|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
437616|NCT00525148|O3|Outcome|Afatinib 50 mg|Subjects receiving 50 mg of Afatinib daily.
437617|NCT00525148|O2|Outcome|Afatinib 40 mg|Subjects receiving 40 mg of Afatinib daily.
437618|NCT00525148|O1|Outcome|Afatinib 30 mg|Subjects receiving 30 mg of Afatinib daily.
437619|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437620|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437621|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437622|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437623|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437624|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437625|NCT00525148|O1|Outcome|Afatinib|Patients in the four initial cohorts are combined in the efficacy presentations. Patients start once daily oral treatment of BIBW 2992 (Afatinib) at 50 mg before protocol amendment 2 (17 Dec 2008), until progression or undue adverse events (AEs) development. Patients can be dose-reduced up to two times if needed after temporary interruption of treatment due to drug- related AEs. After protocol amendment 2, the starting dose of BIBW 2992 was reduced to 40 mg, with 2 possible dose reductions if needed after temporary dose interruption due to drug-related AEs.
437626|NCT00525148|E2|Reported Event|BIBW 50mg|Subjects receiving starting doses 50 mg of Afatinib daily.
437627|NCT00525148|E1|Reported Event|BIBW 40mg|Subjects receiving starting doses 40 mg of Afatinib daily.
437628|NCT00525135|B1|Baseline|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437629|NCT00525135|P1|Participant Flow|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437630|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437631|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437632|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437633|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437634|NCT00525135|O1|Outcome|Study Intervention|Patients receive valproic acid daily for 16 weeks.
437636|NCT00524940|B1|Baseline|Study Group|All participants enrolled and received Fluzone® Vaccine
437637|NCT00524940|P1|Participant Flow|Study Group|All participants enrolled and received Fluzone® Vaccine
437638|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
437639|NCT00524940|O1|Outcome|Study Group|All participants enrolled and received Fluzone® Vaccine
437640|NCT00524940|E1|Reported Event|Study Group|All participants enrolled and received Fluzone® Vaccine
437641|NCT00524771|B3|Baseline|Total|Total of all reporting groups
437642|NCT00524771|B2|Baseline|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
437643|NCT00524771|B1|Baseline|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
437644|NCT00524771|P2|Participant Flow|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
437645|NCT00524771|P1|Participant Flow|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
437646|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
437647|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
437648|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
437649|NCT00524771|O3|Outcome|COC2|A priori defined subgroup of users of combined oral contraceptive pills without desogestrel or gestodene
437650|NCT00524771|O2|Outcome|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
437651|NCT00524771|O1|Outcome|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
437652|NCT00524771|E2|Reported Event|Combined Oral Contraceptives (COC)|Users of combined oral contraceptive pills
437653|NCT00524771|E1|Reported Event|NuvaRing|Users of an etonogestrel-containing and ethinylestradiol-containing vaginal ring
437654|NCT00524745|B5|Baseline|Total|Total of all reporting groups
437655|NCT00524745|B4|Baseline|Standard (0,2,6 Month) Schedule|
437656|NCT00524745|B3|Baseline|0,12,24 Month Schedule|
437657|NCT00524745|B2|Baseline|0,6,12 Month Schedule|
437658|NCT00524745|B1|Baseline|0,3,9 Month Schedule|
437659|NCT00524745|P4|Participant Flow|Standard (0,2,6 Month) Schedule|
437660|NCT00524745|P3|Participant Flow|0,12,24 Month Schedule|
437661|NCT00524745|P2|Participant Flow|0,6,12 Month Schedule|
437662|NCT00524745|P1|Participant Flow|0,3,9 Month Schedule|
437663|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
437664|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
437665|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
437666|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
437667|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
437668|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
437669|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
437670|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
437671|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
437672|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
437673|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
437674|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
437675|NCT00524745|O4|Outcome|Standard (0,2,6 Month) Schedule|
437676|NCT00524745|O3|Outcome|0,12,24 Month Schedule|
437677|NCT00524745|O2|Outcome|0,6,12 Month Schedule|
437678|NCT00524745|O1|Outcome|0,3,9 Month Schedule|
437679|NCT00524745|E4|Reported Event|Standard (0,2,6 Month) Schedule|
437680|NCT00524745|E3|Reported Event|0,12,24 Month Schedule|
437681|NCT00524745|E2|Reported Event|0,6,12 Month Schedule|
437682|NCT00524745|E1|Reported Event|0,3,9 Month Schedule|
437683|NCT00524680|B5|Baseline|Total|Total of all reporting groups
437684|NCT00524680|B4|Baseline|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437685|NCT00524680|B3|Baseline|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437686|NCT00524680|B2|Baseline|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437687|NCT00524680|B1|Baseline|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437688|NCT00524680|P4|Participant Flow|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437689|NCT00524680|P3|Participant Flow|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437690|NCT00524680|P2|Participant Flow|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437691|NCT00524680|P1|Participant Flow|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437692|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437693|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437694|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437695|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437696|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437697|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437698|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437699|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437700|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437701|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437702|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437703|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437704|NCT00524680|O4|Outcome|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437705|NCT00524680|O3|Outcome|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437706|NCT00524680|O2|Outcome|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437707|NCT00524680|O1|Outcome|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437708|NCT00524680|E4|Reported Event|Arm IV: Vitamin D 10,000 IU Daily|"Patients receive 10,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437709|NCT00524680|E3|Reported Event|Arm III: Vitamin D 8000 IU Daily|"Patients receive 8,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437710|NCT00524680|E2|Reported Event|Arm II: Vitamin D 6000 IU Daily|"Patients receive 6,000 IU of vitamin D3 once daily.~cholecalciferol: Given orally"
437711|NCT00524680|E1|Reported Event|Arm I: Vitamin D 4000 IU Daily|"Patients receive 4,000 IU of oral cholecalciferol (vitamin D3) once daily.~cholecalciferol: Given orally"
437712|NCT00524589|B1|Baseline|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
437713|NCT00524589|P1|Participant Flow|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
437714|NCT00524589|O1|Outcome|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
437715|NCT00524589|E1|Reported Event|Dexamethasone and Calcitriol|"Patients receive oral dexamethasone once on days 1 and 2 and calcitriol IV over 1 hour on day 2. Treatment repeats weekly.~calcitriol: IV~dexamethasone: Oral~protein expression analysis: Correlative Study~laboratory biomarker analysis: Correlative Study"
437716|NCT00524576|B3|Baseline|Total|Total of all reporting groups
437717|NCT00524576|B2|Baseline|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437718|NCT00524576|B1|Baseline|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437719|NCT00524576|P2|Participant Flow|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437720|NCT00524576|P1|Participant Flow|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437721|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437722|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437723|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437724|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437725|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437726|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437727|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437728|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437729|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437730|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437731|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437732|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437733|NCT00524576|O2|Outcome|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437734|NCT00524576|O1|Outcome|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437775|NCT00524420|O2|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437735|NCT00524576|E2|Reported Event|Engerix 3 Doses + Challenge Dose|Subjects received 3 doses of Engerix™-B (Month 0, 1 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437736|NCT00524576|E1|Reported Event|Engerix 2 Doses + Challenge Dose|Subjects received 2 doses of Engerix™-B (Month 0 and 6) in the primary study and a single dose of Engerix™-B during the booster study.
437737|NCT00524537|B1|Baseline|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437738|NCT00524537|P1|Participant Flow|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437739|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437740|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437741|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437742|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437743|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437744|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437745|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437746|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437747|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437748|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437749|NCT00524537|O1|Outcome|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437750|NCT00524537|E1|Reported Event|Adalimumab (Humira) Treatment|Adult patients with moderately to severely active CD treated with Humira in a routine clinical practice setting.
437751|NCT00524511|B3|Baseline|Total|Total of all reporting groups
437752|NCT00524511|B2|Baseline|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
437753|NCT00524511|B1|Baseline|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
437754|NCT00524511|P2|Participant Flow|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
437755|NCT00524511|P1|Participant Flow|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
437756|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
437757|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
437758|NCT00524511|O2|Outcome|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
437759|NCT00524511|O1|Outcome|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
437760|NCT00524511|E2|Reported Event|Group Receiving Standard Skin Closure Method (Surgical Staples|Women receiving standard surgical skin staples
437761|NCT00524511|E1|Reported Event|Group Receiving Alternative Skin Closure Method (Dermabond)|Women receiving Dermabond for skin closure
437762|NCT00524459|B1|Baseline|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437763|NCT00524459|P1|Participant Flow|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437764|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437765|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437766|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437767|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437768|NCT00524459|O1|Outcome|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437769|NCT00524459|E1|Reported Event|DOXIL (Pegylated Liposomal Doxorubicin) and Docetaxel|DOXIL 30 mg/m2 + Docetaxel 60 mg/m2 every 21 days x 6 cycles Pegylated Filgrastim given on day 2 or 3 post chemotherapy
437770|NCT00524420|B3|Baseline|Total|Total of all reporting groups
437771|NCT00524420|B2|Baseline|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437772|NCT00524420|B1|Baseline|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437773|NCT00524420|P2|Participant Flow|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437774|NCT00524420|P1|Participant Flow|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437899|NCT00524121|O1|Outcome|pEGFR<=20 μg/ml|Cut at median of 20 pEGFR<=20 μg/ml
437776|NCT00524420|O1|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437777|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437778|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437779|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437780|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437781|NCT00524420|O2|Outcome|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437782|NCT00524420|O1|Outcome|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437783|NCT00524420|E2|Reported Event|Sham rTMS|Sham rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
437784|NCT00524420|E1|Reported Event|Active rTMS|rTMS : 10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
437785|NCT00524394|B1|Baseline|INFANTS|INFANTS 0 to 3 days of life >1500 G OR >32 WEEKS GA
437786|NCT00524394|P1|Participant Flow|Infants 0 to 3 Days of Life >1500 g or >32 Weeks GA|Infants born at >32 weeks of gestagional age or > 1500gm between 0 to 3 Days of Life
437787|NCT00524394|O1|Outcome|INFANTS 0 to 3 Days of Life (DOL) >1500 G OR >32 WEEKS GA|INFANTS 0 to 3 days of life born with >1500 gm OR >32 WEEKS gestational age
437788|NCT00524394|E1|Reported Event|Infants0-3 Days of Life >1500g or >32 Weeks GA|Infants born at 32 weeks of gestacional age or >1500 mg at 0-3 days of life .
437789|NCT00524368|B3|Baseline|Total|Total of all reporting groups
437790|NCT00524368|B2|Baseline|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437791|NCT00524368|B1|Baseline|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437792|NCT00524368|P2|Participant Flow|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437793|NCT00524368|P1|Participant Flow|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437794|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437795|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437796|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437797|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437798|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437799|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437800|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437801|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437802|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437803|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437804|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437805|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437806|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437807|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437808|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437809|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437810|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437811|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437812|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437813|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437814|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437815|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437816|NCT00524368|O2|Outcome|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437817|NCT00524368|O1|Outcome|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437818|NCT00524368|E2|Reported Event|DRV/Rtv 600/100 mg Twice Daily|One 600 mg darunavir (DRV) tablet + one 100 mg capsule of ritonavir (rtv) given twice daily
437819|NCT00524368|E1|Reported Event|DRV/Rtv 800/100 mg Once Daily|Two 400 mg tablets of darunavir (DRV) + one 100 mg capsule of ritonavir (rtv) once daily
437820|NCT00524342|B1|Baseline|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
437821|NCT00524342|P1|Participant Flow|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
437822|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
437823|NCT00524342|O1|Outcome|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
437824|NCT00524342|E1|Reported Event|IL-11|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, then once daily on day 1-7 during each of six consecutive menstrual cycles
437825|NCT00524316|B1|Baseline|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437826|NCT00524316|P1|Participant Flow|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437827|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437828|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437829|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437830|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437831|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437832|NCT00524316|O1|Outcome|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437833|NCT00524316|E1|Reported Event|Treatment: Sunitinib and Chemoembolization|Treatment: Cycle (C)1-Sunitinib 37.5mg po d1-7 followed by TACE with doxorubicin in lipodiol on d8, continued sunitinib 37.5mg po qd d15-36 followed by 2 weeks off. C2 onwards- sunitinib 4 weeks on and 2 weeks off, with dose escalation to 50 mg in pts without any grade 3 toxicities in C1.
437834|NCT00524303|B4|Baseline|Total|Total of all reporting groups
437835|NCT00524303|B3|Baseline|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437836|NCT00524303|B2|Baseline|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437837|NCT00524303|B1|Baseline|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437838|NCT00524303|P3|Participant Flow|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437839|NCT00524303|P2|Participant Flow|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437840|NCT00524303|P1|Participant Flow|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437841|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437842|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437843|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437844|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437845|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437846|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437847|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437848|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437849|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437850|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437851|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams (mg)/kilogram (kg) on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter. Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel 80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437894|NCT00524121|B1|Baseline|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437900|NCT00524121|O2|Outcome|EGFR>120 μg/ml|Cut at median of 120 EGFR>120 μg/ml
437852|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437853|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437854|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437855|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437856|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437857|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437858|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437859|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437860|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437861|NCT00524303|O3|Outcome|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437862|NCT00524303|O2|Outcome|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437863|NCT00524303|O1|Outcome|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437895|NCT00524121|P1|Participant Flow|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437896|NCT00524121|O2|Outcome|EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
437897|NCT00524121|O1|Outcome|No EGFR Mutation|Assessed by fluorescent in situ hybridization (FISH)
437864|NCT00524303|E3|Reported Event|Trastuzumab+Lapatinib|Participants received trastuzumab (given as in Arm 1) and lapatinib (750/1000 mg PO QD). Participants were treated with these medications in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab+lapatinib.
437865|NCT00524303|E2|Reported Event|Lapatinib|Participants received lapatinib alone (1250 mg orally [PO] once daily [QD]). Participants were treated with lapatinib in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-FU 500 mg/m^2, epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with lapatinib.
437866|NCT00524303|E1|Reported Event|Trastuzumab|Participants received trastuzumab alone (a loading dose of 4 milligrams [mg]/kilogram [kg] on Day 1, followed by a dose of 2 mg/kg on Day 1 of Week 2 and weekly thereafter). Participants were treated with trastuzumab in a 2-week run-in period. On Day 14, a second core needle biopsy was performed, followed by initiation of chemotherapy with 2 combination regimens of 4 cycles each (1 cycle=3 weeks): FEC75 (5-fluorouracil [5-FU] 500 mg/meters squared [m^2], epirubicin 75 mg/m^2, cyclophosphamide 500 mg/m^2 x 4 cycles on Day 1), then paclitaxel (80 mg/m^2 x 4 cycles on Day 1, Day 8, and Day 15) in combination with trastuzumab.
437867|NCT00524264|B3|Baseline|Total|Total of all reporting groups
437868|NCT00524264|B2|Baseline|Vehicle Solution|
437869|NCT00524264|B1|Baseline|Ketorolac Solution|
437870|NCT00524264|P2|Participant Flow|Vehicle Solution|
437871|NCT00524264|P1|Participant Flow|Ketorolac Solution|
437872|NCT00524264|O2|Outcome|Vehicle Solution|
437873|NCT00524264|O1|Outcome|Ketorolac Solution|
437874|NCT00524264|O2|Outcome|Vehicle Solution|
437875|NCT00524264|O1|Outcome|Ketorolac Solution|
437876|NCT00524264|O2|Outcome|Vehicle Solution|
437877|NCT00524264|O1|Outcome|Ketorolac Solution|
437878|NCT00524264|O2|Outcome|Vehicle Solution|
437879|NCT00524264|O1|Outcome|Ketorolac Solution|
437880|NCT00524264|E2|Reported Event|Vehicle Solution|
437881|NCT00524264|E1|Reported Event|Ketorolac Solution|
437882|NCT00524225|B1|Baseline|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
437883|NCT00524225|P1|Participant Flow|Neumega (Interleukin 11, IL-11)|"Neumega (Oprelvekin, Interleukin 11, IL-11) 25 mcg/kg subcutaneously, given for 4 days preoperatively, and on day 5 preoperatively, and for up to 2 days postoperatively~Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure"
437884|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
437885|NCT00524225|O1|Outcome|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
437886|NCT00524225|E1|Reported Event|Neumega (Interleukin 11, IL-11)|Neumega (Oprelvekin, Interleukin 11, IL-11): 25 micrograms/kg by subcutaneous injection once daily for four days, followed by once daily on days 1-3 before and after elective surgery or dental procedure
437887|NCT00524134|B1|Baseline|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437888|NCT00524134|P1|Participant Flow|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437889|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437890|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437891|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437892|NCT00524134|O1|Outcome|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437893|NCT00524134|E1|Reported Event|Carvedilol-CR|"Carvedilol-CR up to 80mg daily, used as a P-glycoprotein inhibitor to increase drug concentrations in specific regions of the brain.~Carvedilol-CR: Week 1: 20mg capsule once daily Week 2-3: 40mg capsule once daily Week 4-15: 80mg once daily Week 16: tapering (40mg/day x 4d, then 20mg/day x 3d), unless the patient wishes to continue receiving the medication."
437898|NCT00524121|O2|Outcome|pEGFR>20 μg/ml|Cut at median of 20 pEGFR>20 μg/ml
437901|NCT00524121|O1|Outcome|EGFR<=120 μg/ml|Cut at median of 120 EGFR<=120 μg/ml
437902|NCT00524121|O3|Outcome|Never Smokers|
437903|NCT00524121|O2|Outcome|Former Smokers|
437904|NCT00524121|O1|Outcome|Current Smokers|
437905|NCT00524121|O2|Outcome|Erlotinib in Combination With Radiotherapy at Week 3|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437906|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy at Baseline|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437907|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437908|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437909|NCT00524121|O1|Outcome|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437910|NCT00524121|E1|Reported Event|Erlotinib in Combination With Radiotherapy|Erlotinib (150 mg) administered orally once daily starting day 1 and continued with radiotherapy (RT) and through day 365 (one year therapy duration). RT will be administered day 1-28 (Mon-Fri) in dose of 1.8 Gy per fraction.
437911|NCT00524043|B4|Baseline|Total|Total of all reporting groups
437912|NCT00524043|B3|Baseline|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437913|NCT00524043|B2|Baseline|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437914|NCT00524043|B1|Baseline|Placebo|One oral placebo tablet daily for 6 weeks.
437915|NCT00524043|P3|Participant Flow|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437916|NCT00524043|P2|Participant Flow|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437917|NCT00524043|P1|Participant Flow|Placebo|One oral placebo tablet daily for 6 weeks.
437918|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437919|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437920|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
437921|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437922|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437923|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
437924|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437925|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437926|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
437927|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437928|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437929|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
437930|NCT00524043|O3|Outcome|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437931|NCT00524043|O2|Outcome|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437932|NCT00524043|O1|Outcome|Placebo|One oral placebo tablet daily for 6 weeks.
437933|NCT00524043|E3|Reported Event|Paliperidone ER 1.5 mg|Experimental dose of paliperidone ER. One 1.5 mg oral tablet daily for 6 weeks.
437934|NCT00524043|E2|Reported Event|Paliperidone ER 6 mg|Active comparator. One 6 mg oral tablet daily for 6 weeks. The 6 mg dose of paliperidone ER has been shown to have efficacy in previous studies.
437935|NCT00524043|E1|Reported Event|Placebo|One oral placebo tablet daily for 6 weeks.
437936|NCT00524030|B3|Baseline|Total|Total of all reporting groups
437937|NCT00524030|B2|Baseline|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437938|NCT00524030|B1|Baseline|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437939|NCT00524030|P2|Participant Flow|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
438837|NCT00521456|E2|Reported Event|Vehicle Solution|
437940|NCT00524030|P1|Participant Flow|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437941|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437942|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437943|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437944|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437945|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437946|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437947|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437948|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437949|NCT00524030|O2|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437950|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437951|NCT00524030|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437952|NCT00524030|O1|Outcome|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437953|NCT00524030|E2|Reported Event|Pregabalin 600 mg/Day|Pregabalin 300 mg capsules, administered orally, BID for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (2-week pregabalin dose escalation/6-week AED taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase. Dose escalation to 600 mg/day occurred over 2 weeks as follows: 75 mg BID on Days 1-7, 150 mg BID on Days 8-14, and 300 mg BID from Day 15 up to Week 20.
437954|NCT00524030|E1|Reported Event|Pregabalin 150 mg/Day|Pregabalin 75 milligram (mg) capsules, administered orally twice daily (BID), for up to a 20-week Double-Blind Treatment Phase, which included an 8-week conversion period (antiepileptic drug [AED] taper) and a 12-week pregabalin Monotherapy Period, followed by a 1-week Titration/Taper phase.
437955|NCT00523991|B3|Baseline|Total|Total of all reporting groups
437956|NCT00523991|B2|Baseline|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437957|NCT00523991|B1|Baseline|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437958|NCT00523991|P2|Participant Flow|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437959|NCT00523991|P1|Participant Flow|Placebo|Placebo matching tiotropium via HandiHaler® + Pro Re Nata (PRN) albuterol
437960|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437961|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437962|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437963|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437964|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437965|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437966|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437967|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437968|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437969|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437970|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437971|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437972|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437973|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437974|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437975|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437976|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437977|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437978|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437979|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437980|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437981|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437982|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437983|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437984|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437985|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437986|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437987|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437988|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437989|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437990|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437991|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437992|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437993|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437994|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437995|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437996|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437997|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
437998|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
437999|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438000|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438001|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438002|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438003|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438004|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438005|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438006|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438007|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438008|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438009|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438010|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438011|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438012|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438013|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438014|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438015|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438016|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438017|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438018|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438019|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438020|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438021|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438022|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438023|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438024|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438025|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438026|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438027|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438028|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438029|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438030|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438838|NCT00521456|E1|Reported Event|Ketorolac Solution|
438031|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438032|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438033|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438034|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438035|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438036|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438037|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438038|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438039|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438040|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438041|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438042|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438043|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438044|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438045|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438046|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438047|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438048|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438049|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438050|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438051|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438052|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438053|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438054|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438055|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438056|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438057|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438058|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438059|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438060|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438061|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438062|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438063|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438064|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438065|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438066|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438067|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438068|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438069|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438070|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438071|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438072|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438073|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438074|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438075|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438076|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438077|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438078|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438079|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438080|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438081|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438082|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438083|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438084|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438085|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438086|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438087|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438088|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438089|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438090|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438091|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438092|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438093|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438094|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438095|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
443236|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
438096|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438097|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438098|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438099|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438100|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438101|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438102|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438103|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438104|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438105|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438106|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438107|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438108|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438109|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438110|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438111|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438112|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438113|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438114|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438115|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438116|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438117|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438118|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438119|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438120|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438121|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438122|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438123|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438124|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438125|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438126|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438127|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438128|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438129|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438130|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438131|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438132|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438133|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438134|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438135|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438136|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438137|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438138|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438139|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438140|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438141|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438142|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438143|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438144|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438145|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438146|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438147|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438148|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438149|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438150|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438151|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438152|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438153|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438154|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438155|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438156|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438157|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438158|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438159|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438160|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
443242|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
438161|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438162|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438163|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438164|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438165|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438166|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438167|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438168|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438169|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438170|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438171|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438172|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438173|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438174|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438175|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438176|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438177|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438178|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438179|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438180|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438181|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438182|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438183|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438184|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438185|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438186|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438187|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438188|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438189|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438190|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438191|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438192|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438193|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438194|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438195|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438196|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438197|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438198|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438199|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438200|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438201|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438202|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438203|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438204|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438205|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438206|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438207|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438208|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438209|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438210|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438211|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438212|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438213|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438214|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438215|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438216|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438217|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438218|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438219|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438220|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438221|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438222|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438223|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438224|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438225|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
444443|NCT00507130|B5|Baseline|Total|Total of all reporting groups
438226|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438227|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438228|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438229|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438230|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438231|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438232|NCT00523991|O2|Outcome|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438233|NCT00523991|O1|Outcome|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438234|NCT00523991|E2|Reported Event|Tiotropium|18 mcg tiotropium via HandiHaler® + PRN albuterol
438235|NCT00523991|E1|Reported Event|Placebo|Placebo matching tiotropium via HandiHaler® + PRN albuterol
438236|NCT00523978|B3|Baseline|Total|Total of all reporting groups
438237|NCT00523978|B2|Baseline|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
438238|NCT00523978|B1|Baseline|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
438239|NCT00523978|P2|Participant Flow|Standard Treatment With Drugs Only|a control group receiving only an Atrial Fibrillation Drug. 4 Subject withdrew consent and 1 subject was a screen failure. Therefore- Control Treatment group N= 82.
438240|NCT00523978|P1|Participant Flow|Cryoablation|an experimental group receiving cryoablation and, optionally, a previously failed Atrial Fibrillation Drug.3 Subjects withdrew consent 5 subjects were a screen failure. Therefore N=163 for Experimental group.
438241|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438242|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
438243|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438244|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
438245|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438246|NCT00523978|O2|Outcome|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
438247|NCT00523978|O1|Outcome|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438248|NCT00523978|O1|Outcome|Cryoablation|Experimental group or group that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438249|NCT00523978|E2|Reported Event|Standard Treatment With Drugs Only|A control group receiving only an Atrial Fibrillation Drug who have not previously failed a AF study drug.
438250|NCT00523978|E1|Reported Event|Cryoablation|Experimental group or subjects that were cryoablated with Arctic Front® Cardiac CryoAblation Catheter System, including the FlexCath® Steerable Sheath and Freezor® MAX Cardiac Cryoablation Catheter
438251|NCT00523939|B3|Baseline|Total|Total of all reporting groups
438252|NCT00523939|B2|Baseline|Leukemic|Subjects with Leukemic Meningitis
438253|NCT00523939|B1|Baseline|Lymphomatous|Subjects with Lymphomatous Meningitis
438254|NCT00523939|P2|Participant Flow|Leukemic|Subjects with Leukemic Meningitis
438255|NCT00523939|P1|Participant Flow|Lymphomatous|Subjects with Lymphomatous Meningitis
438256|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
438257|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
438258|NCT00523939|O2|Outcome|Leukemic|Subjects with Leukemic Meningitis
438259|NCT00523939|O1|Outcome|Lymphomatous|Subjects with Lymphomatous Meningitis
438260|NCT00523939|E1|Reported Event|All Subjects|Subjects with Lymphomatous or Leukemic Meningitis.
438261|NCT00523848|B1|Baseline|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438262|NCT00523848|P1|Participant Flow|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438263|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438264|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438265|NCT00523848|O1|Outcome|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438266|NCT00523848|E1|Reported Event|VDT: VELCADE, Doxil and Low-dose Thalidomide|
438267|NCT00523809|B1|Baseline|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
438268|NCT00523809|P1|Participant Flow|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
438269|NCT00523809|O1|Outcome|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
438293|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438270|NCT00523809|E1|Reported Event|Bevacizumab + Fludarabine + Melphalan|Bevacizumab 10 mg/kg intravenous (IV) on Day 1; Fludarabine 25 mg/m^2 IV Daily over 5 Days; Melphalan 70 mg/m^2 IV Daily over 2 Days; Thymoglobulin 0.5 mg/kg IV on Day - 3, 1.5 mg/kg IV on Day - 2, and 2 mg/kg IV on Day -1; plus Allogeneic Hematopoietic Stem Cell Transplantation on Day 8.
438271|NCT00523744|B1|Baseline|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
438272|NCT00523744|P1|Participant Flow|Amlodipine(AML)+Olmesartan, AML+Valsartan, AML+Valsartan+HCTZ|During the Treatment Phase 1, participants received 1 week of treatment with olmesartan 10 mg and amlodipine 5 mg once daily in free combination, followed by three weeks of treatment with olmesartan 20 mg plus amlodipine 10 mg once daily in free combination. During the Treatment Phase 2 participants received amlodipine 10 mg plus valsartan 160 mg for 4 weeks. During the Extension Phase, participants received 4 weeks treatment with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg.
438273|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438274|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438275|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438276|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438277|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438278|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438279|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438280|NCT00523744|O1|Outcome|Amlodipine+Valsartan+HCTZ - Phase 3|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438281|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438282|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438283|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438284|NCT00523744|O1|Outcome|Amlodipine+Valsartan - Phase 2|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438285|NCT00523744|E3|Reported Event|Phase 3 - Amlodipine+Valsartan+HCTZ|Patients with uncontrolled mean sitting systolic or diastolic blood pressure (msDBP ≥ 90 mmHg and/or msSBP ≥ 140 mmHg) at the end of Phase 2 were offered a 4 week treatment extension with amlodipine 10 mg plus valsartan 160 mg plus hydrochlorothiazide (HCTZ) 12.5 mg taken orally in the morning.
438286|NCT00523744|E2|Reported Event|Phase 2 - Amlodipine+Valsartan|Patients with uncontrolled mean sitting diastolic BP (msDBP ≥ 90 mmHg) at the end of Phase 1 were treated for 4 weeks with amlodipine 10 mg plus valsartan 160 mg taken orally in the morning.
438287|NCT00523744|E1|Reported Event|Phase 1 - Amlodipine+Olmesartan|4 weeks treatment with amlodipine 10 mg plus olmesartan 20 mg taken orally once daily in the morning.
438288|NCT00523718|B3|Baseline|Total|Total of all reporting groups
438289|NCT00523718|B2|Baseline|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438290|NCT00523718|B1|Baseline|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438291|NCT00523718|P2|Participant Flow|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438292|NCT00523718|P1|Participant Flow|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438332|NCT00523614|E1|Reported Event|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
438333|NCT00523549|B3|Baseline|Total|Total of all reporting groups
438294|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438295|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438296|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438297|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438298|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438299|NCT00523718|O2|Outcome|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438300|NCT00523718|O1|Outcome|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438301|NCT00523718|E2|Reported Event|Placebo|"Patients randomized to this arm will receive placebo, formulated to be indistinguishable from riluzole, in addition to the medication regimen they are on at study enrollment.~placebo: placebo, 1 capsule PO bid, 12 weeks"
438302|NCT00523718|E1|Reported Event|Riluzole|"Patients randomized to this arm will receive riluzole augmentation, at a standard, fixed dose (50 mg bid), in addition to the medication regimen they are on at enrollment~riluzole: 50 mg PO bid, 12 weeks"
438303|NCT00523705|B3|Baseline|Total|Total of all reporting groups
438304|NCT00523705|B2|Baseline|Sugar Pill|Placebo tablets matched to drug.
438305|NCT00523705|B1|Baseline|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438306|NCT00523705|P2|Participant Flow|Sugar Pill|Placebo tablets matched to drug.
438307|NCT00523705|P1|Participant Flow|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438308|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
438309|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438310|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
438311|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438312|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
438313|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438314|NCT00523705|O2|Outcome|Sugar Pill|Placebo tablets matched to drug.
438315|NCT00523705|O1|Outcome|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438316|NCT00523705|E2|Reported Event|Sugar Pill|Placebo tablets matched to drug.
438317|NCT00523705|E1|Reported Event|Escitalopram|Escitalopram 10 mg tablets taken once daily. Dosing in the luteal phase of the menstrual cycle (estimated day 14 to day 2). Start at 10 mg/day (1 tablet) in the first treatment cycle. If unimproved, increase to 20 mg/day (2 tablets) in cycle 2 if not precluded by side effects.
438318|NCT00523640|B1|Baseline|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438319|NCT00523640|P1|Participant Flow|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438320|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438321|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438322|NCT00523640|O1|Outcome|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438323|NCT00523640|E1|Reported Event|Combination of Gemcitabine, Capecitabine, and Bevacizumab|combination of gemcitabine, capecitabine, and bevacizumab
438324|NCT00523614|B3|Baseline|Total|Total of all reporting groups
438325|NCT00523614|B2|Baseline|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
438326|NCT00523614|B1|Baseline|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
438327|NCT00523614|P2|Participant Flow|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
438328|NCT00523614|P1|Participant Flow|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
438329|NCT00523614|O2|Outcome|Controls|Women without a venous thromboembolism who are between 15 and 49 years old
438330|NCT00523614|O1|Outcome|Cases|Women with a venous thromboembolism who are between 15 and 49 years old
438331|NCT00523614|E2|Reported Event|Controls|Women without a venous thromboembolism diagnosis who are between 15 and 49 years old
444534|NCT00506831|E1|Reported Event|Imatinib Mesylate|
438334|NCT00523549|B2|Baseline|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438335|NCT00523549|B1|Baseline|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438336|NCT00523549|P2|Participant Flow|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438337|NCT00523549|P1|Participant Flow|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438338|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438339|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438340|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438341|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438342|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438343|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438355|NCT00523419|P1|Participant Flow|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438344|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438345|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438346|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438347|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438348|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438349|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438350|NCT00523549|O2|Outcome|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438351|NCT00523549|O1|Outcome|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438352|NCT00523549|E2|Reported Event|Standard Treatment Regimen|"(Valsartan + Amlodipine to target SBP of < 140 mmHg). Patients in the standard treatment regimen had the study medication up-titrated until the SBP goal of < 140 mm Hg was achieved.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2 patients were up-titrated to valsartan 160 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. At week 4 patients were up-titrated to valsartan 320 mg + amlodipine 10 mg only if they were not at SBP target < 140 mm Hg. Patients not at SBP target < 140 mm Hg by Week 8 or at any study visit thereafter received additional antihypertensive medications."
438353|NCT00523549|E1|Reported Event|Intensive Treatment Regimen|"(Valsartan + Amlodipine to target SBP < 130 mm Hg). Patients in the intensive treatment regimen had the study medication force-titrated to the maximum tolerated dose with the goal to achieve an SBP < 130 mm Hg.~At week 0 patients received valsartan 160 mg + amlodipine 5 mg. At week 2, patients were force-titrated to valsartan 160 mg + amlodipine 10 mg. At week 4, patients were force titrated to valsartan 320 mg + amlodipine 10 mg. At week 8, patients who reached the SBP target < 130 mm Hg stayed on their current dose valsartan 320 mg + amlodipine 10 mg or the maximum tolerated dose as per the investigator’s discretion. Patients not at SBP target < 130 mm Hg at week 8 or any study visits thereafter received other additional antihypertensive medications."
438354|NCT00523419|B1|Baseline|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438356|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438357|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438358|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438359|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438360|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438361|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438362|NCT00523419|O1|Outcome|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438363|NCT00523419|E1|Reported Event|Pemetrexed|Participants received pemetrexed 500 milligrams per square meter (mg/m^2) by intravenous (IV) infusion of 10 minutes on Day 1 of each 21-day cycle
438364|NCT00523367|B1|Baseline|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
438365|NCT00523367|P1|Participant Flow|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
438366|NCT00523367|O1|Outcome|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
438367|NCT00523367|E1|Reported Event|COPD Patients With GERD Symptoms|Patients with a diagnosis of COPD with weekly GERD symptoms will be asked to complete GERD and quality of life questionnaires. These questionnaires queried for GERD symptoms and an assessment of overall health during the previous year.
438368|NCT00523341|B3|Baseline|Total|Total of all reporting groups
438369|NCT00523341|B2|Baseline|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438370|NCT00523341|B1|Baseline|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438371|NCT00523341|P2|Participant Flow|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438372|NCT00523341|P1|Participant Flow|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438373|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438374|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438375|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438376|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438377|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438378|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438379|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438380|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438381|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438382|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438383|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438384|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438385|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438417|NCT00523237|O1|Outcome|Enfuvirtide Switch to Raltegravir Arm|patients were switched from Enfuvirtide to Raltegravir
438386|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438387|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438388|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438389|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438390|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438391|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438392|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438393|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438394|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438395|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438396|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438397|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438398|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438399|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438400|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438401|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438402|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438403|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438404|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438405|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438406|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438407|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438408|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438409|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438410|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438411|NCT00523341|O2|Outcome|Denosumab / Denosumab|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study (total of 10 years treatment).
438412|NCT00523341|O1|Outcome|Placebo / Denosumab|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years in the extension study.
438413|NCT00523341|E2|Reported Event|Denosumab/ Denosumab 60 mg Q6M|Participants who were randomized to denosumab in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years (total of 10 years treatment).
438414|NCT00523341|E1|Reported Event|Placebo/ Denosumab 60 mg Q6M|Participants who were randomized to placebo in the core study received a 60 mg subcutaneous injection of denosumab every 6 months for up to seven years.
438415|NCT00523237|B1|Baseline|Raltegravir|400 mg twice daily
438416|NCT00523237|P1|Participant Flow|Raltegravir|400 mg twice daily
438419|NCT00522951|B1|Baseline|Entire Study Population|includes all participants received treatment
438420|NCT00522951|P2|Participant Flow|Gadoteridol Then Gadobutrol|Participants who received two injections of gadoteridol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadobutrol 0.1 mmol/kg bw in Period 2
438421|NCT00522951|P1|Participant Flow|Gadobutrol Then Gadoteridol|Participants who received two injections of gadobutrol 0.1 mmol/kg body weight (bw) in Period 1, and two injections of gadoteridol 0.1 mmol/kg bw in Period 2
438422|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438423|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438424|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438425|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438426|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438427|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438428|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438429|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438430|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438431|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438432|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438433|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438434|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438435|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438436|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438437|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438438|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438439|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438440|NCT00522951|O1|Outcome|Gadobutrol 0.2 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after two injections of gadobutrol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438441|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438442|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw vs. ProHance 0.2 mmol/kg bw|Participants with MR images after first injection of gadobutrol 0.1 mmol/kg bw (dose of 0.1 mmol/kg bw) and two injections of gadoteridol 0.1 mmol/kg bw (total dose of 0.2 mmol/kg bw)
438443|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438444|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438445|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438446|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438447|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438492|NCT00522626|E1|Reported Event|Observational|Opioid exposed pregnancies
438493|NCT00522457|B1|Baseline|Ertumaxomab|
438448|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438449|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438450|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438451|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438452|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438453|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438454|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438455|NCT00522951|O3|Outcome|Gadoteridol (ProHance) 0.2mmol/kg bw|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438456|NCT00522951|O2|Outcome|Gadobutrol 0.2 mmol/kg bw|Participants received second injection (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw. The interval of two bolus injections is 13-15 min
438457|NCT00522951|O1|Outcome|Gadobutrol 0.1 mmol/kg bw|Participants received first injection (intravenous [i.v.]) of gadobutrol 0.1 mmol/kg body weight (bw), corresponding to a dose of 0.1 mmol/kg bw
438458|NCT00522951|E2|Reported Event|ProHance Period|Participants received two injections (i.v.) of gadoteridol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
438459|NCT00522951|E1|Reported Event|Gadobutrol Period|Participants received two injections (i.v.) of gadobutrol 0.1 mmol/kg bw, corresponding to a total dose of 0.2 mmol/kg bw.
438460|NCT00522925|B4|Baseline|Total|Total of all reporting groups
438461|NCT00522925|B3|Baseline|3- PS433540 500mg|500mg once daily for 4 weeks
438462|NCT00522925|B2|Baseline|2- PS433540 200mg|200mg daily for 4 weeks
438463|NCT00522925|B1|Baseline|1- Placebo|Placebo
438464|NCT00522925|P3|Participant Flow|3- PS433540 500mg|500mg once daily for 4 weeks
438465|NCT00522925|P2|Participant Flow|2- PS433540 200mg|200mg daily for 4 weeks
438466|NCT00522925|P1|Participant Flow|1- Placebo|Placebo
438467|NCT00522925|O3|Outcome|3- PS433540 500mg|500mg once daily for 4 weeks
438468|NCT00522925|O2|Outcome|2- PS433540 200mg|200mg daily for 4 weeks
438469|NCT00522925|O1|Outcome|1- Placebo|Placebo
438470|NCT00522925|E3|Reported Event|3- PS433540 500mg|500mg once daily for 4 weeks
438471|NCT00522925|E2|Reported Event|2- PS433540 200mg|200mg daily for 4 weeks
438472|NCT00522925|E1|Reported Event|1- Placebo|Placebo
438473|NCT00522873|B3|Baseline|Total|Total of all reporting groups
438474|NCT00522873|B2|Baseline|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
438475|NCT00522873|B1|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438476|NCT00522873|P2|Participant Flow|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
438477|NCT00522873|P1|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438478|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
438479|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438480|NCT00522873|O2|Outcome|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
438481|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438482|NCT00522873|O1|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438483|NCT00522873|E2|Reported Event|0.5mg NETA / 1.0mg E2 (Activella)|One capsule [0.5mg norethisterone acetate/1.0mg 17β-estradiol (NETA/E2)] per day taken orally for 13 cycles (28 days per cycle).
438484|NCT00522873|E1|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One capsule [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 13 cycles (28 days per cycle).
438485|NCT00522795|B1|Baseline|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
438486|NCT00522795|P1|Participant Flow|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
438487|NCT00522795|O1|Outcome|PPX, Cisplatin, Radiation|
438488|NCT00522795|E1|Reported Event|PPX, Cisplatin, Radiation|"PPX: 50 mg/m2/week days 1, 8, 15, 22, 29, 36.~Cisplatin: 25 mg/m2/week days 1, 8, 15, 22, 29, 36. Cisplatin, will be administered over ½ hour in 250 cc ns weekly for 6 weeks. Cisplatin will be administered after PPX"
438489|NCT00522626|B1|Baseline|Observational|Opioid exposed pregnancies
438490|NCT00522626|P1|Participant Flow|Observational|Opioid exposed pregnancies
438491|NCT00522626|O1|Outcome|Trough Fetal Heart Rate|Opioid exposed pregnancies
438504|NCT00522418|B2|Baseline|Best Medical Practice|Best Medical Practice Without VNS Therapy
438505|NCT00522418|B1|Baseline|VNS Therapy|VNS Therapy + Best Medical Practice
438506|NCT00522418|P2|Participant Flow|Best Medical Practice|Best Medical Practice Without VNS Therapy
438507|NCT00522418|P1|Participant Flow|VNS Therapy|VNS Therapy + Best Medical Practice
438508|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438509|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438510|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score < 40|Population with Baseline Adverse Event Profile Score < 40
438511|NCT00522418|O1|Outcome|Baseline Adverse Event Profile Score >= 40|Population with Baseline Adverse Event Profile Score >= 40
438512|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438513|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438514|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438515|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438516|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438517|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438518|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438519|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438520|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438521|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438522|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438523|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438524|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438525|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438526|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438527|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438528|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438529|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438530|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438531|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438532|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438533|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438534|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438535|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438536|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438537|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438538|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438539|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438540|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438541|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438542|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438543|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438544|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438545|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438546|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438547|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438548|NCT00522418|O2|Outcome|Best Medical Practice|Best Medical Practice Without VNS Therapy
438549|NCT00522418|O1|Outcome|VNS Therapy|VNS Therapy + Best Medical Practice
438550|NCT00522418|E2|Reported Event|Best Medical Practice|Best Medical Practice Without VNS Therapy
438551|NCT00522418|E1|Reported Event|VNS Therapy|VNS Therapy + Best Medical Practice
438552|NCT00522392|B3|Baseline|Total|Total of all reporting groups
438553|NCT00522392|B2|Baseline|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438554|NCT00522392|B1|Baseline|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
438555|NCT00522392|P2|Participant Flow|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438556|NCT00522392|P1|Participant Flow|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
444535|NCT00506714|B3|Baseline|Total|Total of all reporting groups
438557|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438558|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
438559|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438560|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
438561|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438562|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
438563|NCT00522392|O2|Outcome|Arm B (VD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.~bortezomib: Given IV~dexamethasone: Given PO"
438564|NCT00522392|O1|Outcome|Arm A (VRD)|"Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.~bortezomib: Given IV~lenalidomide: Given PO~dexamethasone: Given PO"
438565|NCT00522392|E2|Reported Event|Arm B (Vd Regimen)|Arm B (Vd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib plus dexamethasone. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11 and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15.
438566|NCT00522392|E1|Reported Event|Arm A (VRd Regimen)|Arm A (VRd Regimen) Patients were given consolidation therapy for 8 cycles (1 cycle = 21 days) with the combination bortezomib, dexamethasone and lenalidomide. Patients received each cycle: the standard dose of bortezomib (1.3 mg/m2) on days 1, 4, 8 and 11; fixed dose of lenalidomide at 15 mg orally on days 1-14; and 3 days of dexamethasone at 40 mg total dose per day given on days 1, 8 and 15. Aspirin 325 mg/day orally on days 1-21 of each cycle was required unless the patient was treated with alternate prophylaxis of either low molecular weight heparin or coumadin.
438567|NCT00522379|B6|Baseline|Total|Total of all reporting groups
438568|NCT00522379|B5|Baseline|Placebo|
438569|NCT00522379|B4|Baseline|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438570|NCT00522379|B3|Baseline|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438571|NCT00522379|B2|Baseline|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438572|NCT00522379|B1|Baseline|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438573|NCT00522379|P5|Participant Flow|Placebo|
438574|NCT00522379|P4|Participant Flow|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438575|NCT00522379|P3|Participant Flow|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438576|NCT00522379|P2|Participant Flow|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438577|NCT00522379|P1|Participant Flow|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438578|NCT00522379|O5|Outcome|Placebo|
438579|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438580|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438581|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438582|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438583|NCT00522379|O5|Outcome|Placebo|
438584|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438585|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438586|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438587|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438588|NCT00522379|O5|Outcome|Placebo|
438589|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438590|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438591|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438592|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438593|NCT00522379|O5|Outcome|Placebo|
438594|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438595|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438596|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438597|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438598|NCT00522379|O5|Outcome|Placebo|
438599|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438600|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438601|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438602|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438603|NCT00522379|O5|Outcome|Placebo|
438604|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438605|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438606|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438607|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438608|NCT00522379|O5|Outcome|Placebo|
438609|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438610|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438611|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438612|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438613|NCT00522379|O5|Outcome|Placebo|
438614|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438615|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438616|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438617|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438618|NCT00522379|O5|Outcome|Placebo|
438619|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438620|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438621|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438622|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438623|NCT00522379|O5|Outcome|Placebo|
438624|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438625|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438626|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438627|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438628|NCT00522379|O5|Outcome|Placebo|
438629|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438630|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438631|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438632|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438633|NCT00522379|O5|Outcome|Placebo|
438634|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438635|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438636|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438637|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438638|NCT00522379|O5|Outcome|Placebo|
438639|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438640|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438641|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438642|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438643|NCT00522379|O5|Outcome|Placebo|
438644|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438645|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438646|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438647|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438648|NCT00522379|O5|Outcome|Placebo|
438649|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438650|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438651|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438652|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438653|NCT00522379|O5|Outcome|Placebo|
438654|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438655|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438656|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438657|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438658|NCT00522379|O5|Outcome|Placebo|
438659|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438660|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438661|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438662|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438663|NCT00522379|O5|Outcome|Placebo|
438664|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438665|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438666|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438667|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438668|NCT00522379|O5|Outcome|Placebo|
438669|NCT00522379|O4|Outcome|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438670|NCT00522379|O3|Outcome|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438671|NCT00522379|O2|Outcome|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438672|NCT00522379|O1|Outcome|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438673|NCT00522379|E5|Reported Event|Placebo|
438674|NCT00522379|E4|Reported Event|Rotigotine 8 mg/24 hr|8 mg/24 hr (two 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438675|NCT00522379|E3|Reported Event|Rotigotine 6 mg/24 hr|6 mg/24 hr (one 10 cm^2 & one 20 cm^2) transdermal patches applied daily for titration and maintenance period - 16 weeks
438676|NCT00522379|E2|Reported Event|Rotigotine 4 mg/24 hr|4 mg/24 hr (one 20 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438677|NCT00522379|E1|Reported Event|Rotigotine 2 mg/24 hr|2 mg/24 hr (one 10 cm^2) transdermal patch applied daily for titration and maintenance period - 16 weeks
438678|NCT00522301|B1|Baseline|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
438679|NCT00522301|P1|Participant Flow|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
438680|NCT00522301|O1|Outcome|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
438681|NCT00522301|E1|Reported Event|Oral Sorafenib (BAY43-9006)|Sorafenib will be administered as 400 mg orally daily x 28 days (continuous).
438682|NCT00522275|B1|Baseline|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438683|NCT00522275|P1|Participant Flow|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438684|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438685|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438686|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438687|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438688|NCT00522275|O1|Outcome|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438689|NCT00522275|E1|Reported Event|Lacosamide|Up to 800 mg/day lacosamide (flexible dosing)
438690|NCT00522171|B3|Baseline|Total|Total of all reporting groups
438691|NCT00522171|B2|Baseline|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
438692|NCT00522171|B1|Baseline|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
438693|NCT00522171|P2|Participant Flow|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
438694|NCT00522171|P1|Participant Flow|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
438695|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
438696|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
438697|NCT00522171|O2|Outcome|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
438698|NCT00522171|O1|Outcome|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
438735|NCT00521976|B1|Baseline|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
438736|NCT00521976|P1|Participant Flow|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
438737|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
438738|NCT00521976|O1|Outcome|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
438960|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
438699|NCT00522171|E2|Reported Event|Harmonic® Technology|"Harmonic® Sharp Curved Blade (HF105) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instrument can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures (such as spine and joint space) and thoracic surgery.~The Harmonic® Synergy™ Curved Blade (SNGCB) instruments are indicated for soft tissue incisions when bleeding control and minimal thermal injury are desired. The instruments can be used as an adjunct to or substitute for electrosurgery, lasers, and steel scalpels in general, plastic, gynecologic, exposure to orthopedic structures, Ear Nose and Throat (ENT), including tissues of the soft palate, oral structures, and oropharyngeal airway, and thoracic surgery, including mobilization of the Internal Mammary Artery.~These devices were not modified from their commercially available specifications."
438700|NCT00522171|E1|Reported Event|Electro Surgery|Electro Surgical instruments are used to cut and coagulate tissue using alternating electric current at the surgical site. In Electro Surgery, the patient is included in the circuit and current enters the patient's body.
438701|NCT00522041|B3|Baseline|Total|Total of all reporting groups
438702|NCT00522041|B2|Baseline|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438703|NCT00522041|B1|Baseline|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438704|NCT00522041|P2|Participant Flow|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438705|NCT00522041|P1|Participant Flow|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438706|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438707|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438708|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438709|NCT00522041|O1|Outcome|Cellegisic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438710|NCT00522041|O2|Outcome|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438711|NCT00522041|O1|Outcome|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438712|NCT00522041|E2|Reported Event|Placebo|Participants applied placebo 375 mg ointment anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438713|NCT00522041|E1|Reported Event|Cellegesic (Nitroglycerin 0.4%)|Participants applied Cellegesic 375 mg ointment containing approximately 1.5 mg of nitroglycerin anally twice daily for 21 days. In addition, participants took acetaminophen 650 mg orally twice daily for 21 days.
438714|NCT00521989|B6|Baseline|Total|Total of all reporting groups
438715|NCT00521989|B5|Baseline|Placebo|"Placebo~Placebo: Placebo"
438716|NCT00521989|B4|Baseline|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
438717|NCT00521989|B3|Baseline|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438718|NCT00521989|B2|Baseline|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438719|NCT00521989|B1|Baseline|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438720|NCT00521989|P5|Participant Flow|Placebo|"Placebo~Placebo: Placebo"
438721|NCT00521989|P4|Participant Flow|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
438722|NCT00521989|P3|Participant Flow|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438723|NCT00521989|P2|Participant Flow|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438724|NCT00521989|P1|Participant Flow|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438725|NCT00521989|O5|Outcome|Placebo|"Placebo~Placebo: Placebo"
438726|NCT00521989|O4|Outcome|Prednisolone|"Prednisolone 2.7 mg~Prednisolone: Prednisolone"
438727|NCT00521989|O3|Outcome|CRx-102 (2.7/360 mg)|"CRx-102 Dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438728|NCT00521989|O2|Outcome|CRx-102 (2.7/180 mg)|"CRx-102 Dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438729|NCT00521989|O1|Outcome|CRx-102 (2.7/90 mg)|"CRx-102 (Prednisolone 2.7 mg + Dipyridamole 90 mg)~prednisolone + dipyridamole: CRx-102 (Dose 1), CRx-102 (Dose 2), CRx-102 (Dose 3)"
438730|NCT00521989|E5|Reported Event|CRx-102 (2.7/360 mg)|CRx-102 dose 3 (2.7 mg prednisolone + 360 mg dipyridamole)
438731|NCT00521989|E4|Reported Event|CRx-102 (2.7/180 mg)|CRx-102 dose 2 (2.7 mg prednisolone + 180 mg dipyridamole)
438732|NCT00521989|E3|Reported Event|CRx-102 (2.7/90 mg)|CRx-102 dose 1 (2.7 mg prednisolone + 90 mg dipyridamole)
438733|NCT00521989|E2|Reported Event|Prednisolone|Prednisolone 2.7 mg
438734|NCT00521989|E1|Reported Event|Placebo|Placebo
438739|NCT00521976|E1|Reported Event|Group 1|Men and women admitted with chest pain and a suspicious acute coronary syndrome (ACS)
438740|NCT00521924|B3|Baseline|Total|Total of all reporting groups
438741|NCT00521924|B2|Baseline|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
438742|NCT00521924|B1|Baseline|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
438743|NCT00521924|P2|Participant Flow|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
438744|NCT00521924|P1|Participant Flow|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
438745|NCT00521924|O2|Outcome|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
438746|NCT00521924|O1|Outcome|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
438747|NCT00521924|E2|Reported Event|Basic Treatment (DMARDs)|Rheumatoid Arthritis basic therapy (disease modifying anti-rheumatic drugs [DMARDs])
438748|NCT00521924|E1|Reported Event|Infliximab + Basic Treatment|3 mg/kg infliximab plus basic treatment
438749|NCT00521599|B4|Baseline|Total|Total of all reporting groups
438750|NCT00521599|B3|Baseline|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
438751|NCT00521599|B2|Baseline|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
438752|NCT00521599|B1|Baseline|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
438753|NCT00521599|P3|Participant Flow|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
438754|NCT00521599|P2|Participant Flow|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
438755|NCT00521599|P1|Participant Flow|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
438756|NCT00521599|O3|Outcome|Placebo BID|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
438757|NCT00521599|O2|Outcome|MF DPI 1 x 200 mcg BID|1 inhalation of MF DPI 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily for 8 weeks
438758|NCT00521599|O1|Outcome|MF DPI 2 x 100 mcg BID|2 inhalations of mometasone furoate dry powder inhaler (MF DPI) 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily (BID) for 8 weeks
438759|NCT00521599|E4|Reported Event|Placebo|2 inhalations of placebo matching MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
438760|NCT00521599|E3|Reported Event|MF DPI 1 x 200 Mcg BID|1 inhalation of mometasone furoate dry powder inhaler (MF DPI) 200 mcg plus 2 inhalations of placebo matching MF DPI 100 mcg twice daily (BID) for 8 weeks
438761|NCT00521599|E2|Reported Event|MF DPI 2 x 100 mcg BID|2 inhalations of MF DPI 100 mcg plus 1 inhalation of placebo matching MF DPI 200 mcg twice daily for 8 weeks
438762|NCT00521599|E1|Reported Event|OL 1 X 200 mcg BID|Open-label MF DPI 200 mcg BID
438763|NCT00521586|B3|Baseline|Total|Total of all reporting groups
438764|NCT00521586|B2|Baseline|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438765|NCT00521586|B1|Baseline|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438766|NCT00521586|P2|Participant Flow|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438767|NCT00521586|P1|Participant Flow|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438839|NCT00521365|B1|Baseline|Quetiapine 600 mg|Quetiapine Extended release 600 mg per day either as monotherapy or combined therapy
438768|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438769|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438770|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438771|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438772|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438773|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438774|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438775|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438840|NCT00521365|P1|Participant Flow|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438885|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438776|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438777|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438778|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438779|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438780|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438781|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438782|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438783|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438841|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438886|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438784|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438785|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438786|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438787|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438788|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438789|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438790|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438791|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438883|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438792|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438793|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438794|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438795|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438796|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438797|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
438798|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438806|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438959|NCT00521053|O1|Outcome|All Lesions Treated|
438799|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438800|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438801|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438802|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438803|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438804|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438805|NCT00521586|O1|Outcome|All Participants|Participants received either 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV), or placebo matched to 13vPnC intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL TIV intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). One month after, participants received either Placebo matched to 13vPnC (Dose 2, placebo), or 13vPnC (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438823|NCT00521586|E1|Reported Event|13vPnC+TIV/Placebo: Dose 1 (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
438824|NCT00521456|B3|Baseline|Total|Total of all reporting groups
438825|NCT00521456|B2|Baseline|Vehicle Solution|
438826|NCT00521456|B1|Baseline|Ketorolac Solution|
438827|NCT00521456|P2|Participant Flow|Vehicle Solution|
438828|NCT00521456|P1|Participant Flow|Ketorolac Solution|
438807|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm on Day 1(Dose 1). Placebo matched to 13vPnC vaccine (dose 2) was administered 1 month after vaccination 1, dose 1 (13vPnC+TIV).Participants were then followed-up to 4 years (for 1 month, then 6 month and then yearly follow-up) after dose 2 of vaccination 1. Participants then received 0.5 mL dose of 13vPnC vaccine intramuscular injection into the deltoid muscle of the left arm 5 years after vaccination 1. Participants were further followed-up for 1 month and then for 6 months.
438808|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438809|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438810|NCT00521586|O2|Outcome|Placebo+TIV/13vPnC (Year 0) and 13vPnC (Year 5)|Participants received placebo matched to 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, placebo+TIV). 13vPnC was administered 1 month after (Dose 2, 13vPnC). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438811|NCT00521586|O1|Outcome|13vPnC+TIV/Placebo (Year 0) and 13vPnC (Year 5)|Participants received 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) intramuscular injection into the deltoid muscle of the left arm along with 0.5-mL trivalent inactivated influenza vaccine (TIV) intramuscular injection into the deltoid muscle of the right arm at Year 0 on Day 1 (Dose 1, 13vPnC+TIV). Placebo matched to 13vPnC was administered 1 month after (Dose 2, placebo). Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety. Participants were then followed-up yearly for 4 years. Participants then received 0.5 mL dose of 13vPnC intramuscular injection into the deltoid muscle of the left arm 5 years after initial vaccination. Participants were further followed-up for 1 month, then attended a 6-month follow-up visit for safety.
438812|NCT00521586|E12|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
438813|NCT00521586|E11|Reported Event|Placebo+TIV/13vPnC: 13vPnC (Year 5)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
438814|NCT00521586|E10|Reported Event|Placebo+TIV/13vPnC: Years 1-4|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
438815|NCT00521586|E9|Reported Event|Placebo+TIV/13vPnC: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL dose of 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
438816|NCT00521586|E8|Reported Event|Placebo+TIV/13vPnC: Dose 2 (Year 0)|Participants who received 0.5-mL dose of 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
438817|NCT00521586|E7|Reported Event|Placebo+TIV/13vPnC: Dose 1 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC along with 0.5-mL TIV at Year 0 on Day 1 (Dose 1), were assessed for 1 month after Dose 1.
438818|NCT00521586|E6|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed at the 6-month follow-up visit.
438819|NCT00521586|E5|Reported Event|13vPnC+TIV/Placebo: 13vPnC (Year 5)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, then 0.5 mL dose of 13vPnC 5 years after initial vaccination, were assessed for 1 month after 13vPnC given at Year 5.
438820|NCT00521586|E4|Reported Event|13vPnC+TIV/Placebo: Years 1-4|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed from 6-month follow-up visit at Year 0 to revaccination with 13vPnC given at Year 5.
438821|NCT00521586|E3|Reported Event|13vPnC+TIV/Placebo: 6 Month Follow-up (Year 0)|Participants who received 0.5-mL dose of 13vPnC along with 0.5-mL TIV at Year 0 on Day 1, then 0.5-mL Placebo matched to 13vPnC 1 month after, were assessed at the 6-month follow-up visit.
438822|NCT00521586|E2|Reported Event|13vPnC+TIV/Placebo: Dose 2 (Year 0)|Participants who received 0.5-mL Placebo matched to 13vPnC 1 month after Dose 1 (Dose 2), were assessed for 1 month after Dose 2.
438829|NCT00521456|O2|Outcome|Vehicle Solution|
438842|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438843|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438844|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438845|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438846|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438847|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438848|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438849|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438850|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438851|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438852|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438853|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438854|NCT00521365|O1|Outcome|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438855|NCT00521365|E1|Reported Event|Quetiapine 600 mg|"Once the patient was enrolled, he/she was provided with a bottle that contains enough tablets of quetiapine to complete up-titration regime and whole treatment as follows:~Day 1: One 300 mg tablet in the evening Day 2: Two 300 mg tablet in the evening Day 3 and onwards: Two 300 mg tablets in the evening, efforts must be done to maintain a daily dose of 600 mg/day.~This study is a single arm study. All patients received quetiapine XR 600 mg."
438856|NCT00521352|B3|Baseline|Total|Total of all reporting groups
438857|NCT00521352|B2|Baseline|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438884|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438858|NCT00521352|B1|Baseline|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438859|NCT00521352|P2|Participant Flow|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438860|NCT00521352|P1|Participant Flow|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438861|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438862|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438863|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438864|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438865|NCT00521352|O2|Outcome|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438866|NCT00521352|O1|Outcome|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438867|NCT00521352|E2|Reported Event|Sham|"Placebo repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain."
438868|NCT00521352|E1|Reported Event|Active|"Active repetitive Transcranial Magnetic Stimulation~Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks."
438869|NCT00521339|B1|Baseline|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438870|NCT00521339|P3|Participant Flow|Apremilast 20mg/30mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438871|NCT00521339|P2|Participant Flow|Apremilast 20mg/20mg|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
438872|NCT00521339|P1|Participant Flow|Apremilast 20mg|Participants received 20mg Apremilast capsules by mouth (PO) twice a day (BID) on Days 1 through 85 during the Treatment Phase
438873|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
438874|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
438875|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
438876|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438877|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438878|NCT00521339|O1|Outcome|Apremilast 20mg BID/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438879|NCT00521339|O1|Outcome|Apremilast 20mg/30mg PO BID (Treatment + Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438880|NCT00521339|O1|Outcome|Apremilast 20/30mg BID|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension phase
438881|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438882|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438887|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438888|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438889|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438890|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438891|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438892|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438893|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438894|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438895|NCT00521339|O2|Outcome|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
438896|NCT00521339|O1|Outcome|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
438897|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438898|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438899|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438900|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438901|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438902|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438903|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438904|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438905|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438906|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438907|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438908|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438909|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438910|NCT00521339|O1|Outcome|Apremilast 20mg PO BID|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438911|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438912|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438913|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438914|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438915|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438916|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438917|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438918|NCT00521339|O1|Outcome|Apremilast 20mg|Apremilast 20mg capsules by PO BID for Days 1 through 85 administered during the treatment phase
438919|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
438920|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
438921|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
438922|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438923|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438924|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
438925|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) am and pm for Days 1 through 85 administered during the Treatment Phase
438926|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the treatment phase
438927|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
438928|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID for Days 1 through 85 administered during the treatment phase
438929|NCT00521339|O1|Outcome|Apremilast 20 mg PO BID (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438930|NCT00521339|O1|Outcome|Apremilast 20 mg|Apremilast 20mg capsules PO BID on Days 1 through 85 administered during the Treatment Phase
438931|NCT00521339|E3|Reported Event|Apremilast 20mg/30mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were non-responders (did not achieve PASI-75 response) received 30 mg apremilast BID during the 12-week extension
438932|NCT00521339|E2|Reported Event|Apremilast 20mg/20mg (Extension Phase)|Participants who received 20 mg apremilast BID during the treatment phase (Weeks 0-12) who were responders (achieved a 75% reduction in the Psoriasis Area Severity Index [PASI-75]) continued to receive 20 mg apremilast BID during the 12-week extension phase (Weeks 12-24).
438933|NCT00521339|E1|Reported Event|Apremilast 20 mg (Treatment Phase)|Apremilast 20mg capsules by mouth (PO) twice a day (BID) for Days 1 through 85 administered during the treatment phase
438934|NCT00521144|B6|Baseline|Total|Total of all reporting groups
438935|NCT00521144|B5|Baseline|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
438936|NCT00521144|B4|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 4|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438937|NCT00521144|B3|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 3|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438938|NCT00521144|B2|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 2|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438939|NCT00521144|B1|Baseline|Phase I Obatoclax Mesylate + Topotecan in Solid Tumors Level 1|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438940|NCT00521144|P5|Participant Flow|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
438941|NCT00521144|P4|Participant Flow|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438942|NCT00521144|P3|Participant Flow|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438943|NCT00521144|P2|Participant Flow|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438944|NCT00521144|P1|Participant Flow|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438945|NCT00521144|O5|Outcome|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
438946|NCT00521144|O4|Outcome|Phase 1; Level 4: Obatoclax Mesylate + Topotecan|Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438947|NCT00521144|O3|Outcome|Phase I; Level 3: Obatoclax Mesylate + Topetecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438948|NCT00521144|O2|Outcome|Phase I; Level 2: Obatoclax Mesylate + Topetecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438949|NCT00521144|O1|Outcome|Phase I; Level 1: Obatoclax Mesylate + Topetecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438950|NCT00521144|E5|Reported Event|Phase II Obatoclax Mesylate + Topotecan in SCLC|Obatoclax Mesylate 14 + 14 mg/m2 and Topotecan 1.25 mg/m2
438951|NCT00521144|E4|Reported Event|Phase I; Level 4: Obatoclax Mesylate + Topotecan|Level 4: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 + 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438952|NCT00521144|E3|Reported Event|Phase I; Level 3: Obatoclax Mesylate + Topotecan|Level 3: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 + 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438953|NCT00521144|E2|Reported Event|Phase I; Level 2: Obatoclax Mesylate + Topotecan|Level 2: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 20 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438954|NCT00521144|E1|Reported Event|Phase I; Level 1: Obatoclax Mesylate + Topotecan|Level 1: Obatoclax Mesylate (GX15-070MS) 3 hour infusion, days 1 (and 3), q21 days, 14 mg/m2: Topotecan days 1-5, q21 days, 1.25 mg/m2
438955|NCT00521053|B1|Baseline|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
438956|NCT00521053|P1|Participant Flow|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation. In the treatment phase, participants received a single IL injection of PV-10 into each of up to 20 study lesions on day 0 (i.e., one cycle). Treatment cycles could be repeated at weeks 8, 12 and 16 for new non-target lesions or existing target or non-target lesions not exhibiting complete response (i.e., complete disappearance). Participants were observed for 52 weeks. Radiologic assessments of visceral disease status were performed every 12 weeks throughout the study and patients were transitioned into survival follow-up if at any time the investigator identified clinical or radiologic evidence of distant progression. No other melanoma therapy was permitted during the study interval.
438957|NCT00521053|O2|Outcome|Stage IV|Participants reporting Stage IV disease at baseline
438958|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
438961|NCT00521053|O1|Outcome|Stage III|Participants reporting Stage III disease at baseline
438962|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
438963|NCT00521053|O1|Outcome|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
438964|NCT00521053|E1|Reported Event|PV-10|PV-10 (10% rose bengal disodium): Intralesional injection for chemoablation.
438965|NCT00521014|B1|Baseline|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
438966|NCT00521014|P1|Participant Flow|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma GM-CSF: 250 mcg (flat dose) three times per week for 8 weeks, Rituximab: 375 mg/m2/week for 4 weeks, beginning within 3 days after the first dose of GM-CSF
438967|NCT00521014|O1|Outcome|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
438968|NCT00521014|E1|Reported Event|Relapsed Follicular Lymphoma Patients|Study of GM-CSF (Sargramostim) and Rituximab Following Autologous Transplantation For Relapsed Follicular Lymphoma
438969|NCT00520975|B3|Baseline|Total|Total of all reporting groups
438970|NCT00520975|B2|Baseline|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438971|NCT00520975|B1|Baseline|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438972|NCT00520975|P2|Participant Flow|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438973|NCT00520975|P1|Participant Flow|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438974|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438975|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438976|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438977|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
439769|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
438978|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438979|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438980|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438981|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438982|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438983|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438984|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438985|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438986|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438987|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
439007|NCT00520936|P6|Participant Flow|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
444771|NCT00505765|B4|Baseline|Total|Total of all reporting groups
438988|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438989|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438990|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438991|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438992|NCT00520975|O2|Outcome|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438993|NCT00520975|O1|Outcome|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438994|NCT00520975|E2|Reported Event|Arm B (Chemotherapy and Bevacizumab)|"INDUCTION THERAPY: Patients receive trastuzumab and paclitaxel with or without carboplatin as in Arm A. Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Bevacizumab: Given IV~Carboplatin: Given IV~Paclitaxel: Given IV~Trastuzumab: Given IV"
438995|NCT00520975|E1|Reported Event|Arm A (Chemotherapy and Placebo)|"INDUCTION THERAPY: Patients receive trastuzumab IV over 30-90 minutes on days 1, 8, 15, and 22 and paclitaxel IV over 60 minutes with or without carboplatin IV over 60 minutes on days 1, 8, and 15. Patients also receive placebo IV over 30-90 minutes on day 1 and 15. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.~MAINTENANCE THERAPY: Beginning 1 week after the last dose of induction trastuzumab, patients receive trastuzumab IV over 30-90 minutes and placebo IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~Carboplatin: Given IV~Paclitaxel: Given IV~Placebo: Given IV~Trastuzumab: Given IV"
438996|NCT00520936|B9|Baseline|Total|Total of all reporting groups
438997|NCT00520936|B8|Baseline|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
438998|NCT00520936|B7|Baseline|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
438999|NCT00520936|B6|Baseline|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439000|NCT00520936|B5|Baseline|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439001|NCT00520936|B4|Baseline|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439002|NCT00520936|B3|Baseline|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439003|NCT00520936|B2|Baseline|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439004|NCT00520936|B1|Baseline|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
439005|NCT00520936|P8|Participant Flow|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439006|NCT00520936|P7|Participant Flow|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439008|NCT00520936|P5|Participant Flow|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439009|NCT00520936|P4|Participant Flow|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439010|NCT00520936|P3|Participant Flow|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439011|NCT00520936|P2|Participant Flow|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439012|NCT00520936|P1|Participant Flow|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
439013|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439014|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439015|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439016|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439017|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439018|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439019|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439020|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
439021|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439022|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439023|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439024|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439025|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439026|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439027|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439028|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
439029|NCT00520936|O8|Outcome|Non-Brainstem High-Grade Glioma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439030|NCT00520936|O7|Outcome|Medulloblastoma/Supratentorial Primitive Neuroectodermal Tumor|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439031|NCT00520936|O6|Outcome|Ependymoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439032|NCT00520936|O5|Outcome|Neuroblastoma (Metaiodobenzylguanidine Positive Evaluable)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439033|NCT00520936|O4|Outcome|Neuroblastoma (Measureable Disease)|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439034|NCT00520936|O3|Outcome|Rhabdomyosarcoma|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439035|NCT00520936|O2|Outcome|Ewing's Sarcoma/Peripheral Primitive Neuroectodermal Tumors|Pemetrexed 1910 mg/m^2 (or 60 mg/kg if patient <12 months old)
439036|NCT00520936|O1|Outcome|Osteosarcoma|Pemetrexed 1910 milligrams per meters squared (mg/m^2) (or 60 milligrams per kilogram [mg/kg] if patient <12 months old)
439037|NCT00520936|E1|Reported Event|Pemetrexed|Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient <12 months old)
439038|NCT00520845|B1|Baseline|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439039|NCT00520845|P1|Participant Flow|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439040|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439041|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439042|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439043|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439044|NCT00520845|O1|Outcome|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439045|NCT00520845|E1|Reported Event|Treatment Arm|"Either docetaxel or pemetrexed given with celecoxib~celecoxib: 600 mg will be taken by mouth twice a day for 6 weeks then 400 mg twice a day for up to a year after chemotherapy is discontinued in the absence of progression.~Docetaxel: 75mg/m2 given through a vein over 90 minutes on day 1 of a 3-week cycle~pemetrexed disodium: 500 mg/m2 through a vein over 90 minutes on day 1 of a 3 week cycle.~laboratory biomarker analysis: Blood collection"
439046|NCT00520767|B1|Baseline|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
439047|NCT00520767|P1|Participant Flow|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
439048|NCT00520767|O1|Outcome|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
439049|NCT00520767|E1|Reported Event|Melphalan, Dexamethasone, Bortezomib,|"Bortezomib 1.3 mg/m2 days 1, 8, 15, 22; Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23; Melphalan 9 mg/m2/day days 1-4~bortezomib: Bortezomib 1.3 mg/m2 days 1, 8, 15, 22~dexamethasone: Dexamethasone 40 mg/d days 1, 2, 8, 9, 15, 16, 22, 23~melphalan: Melphalan 9 mg/m2/day days 1-4~microarray analysis: ≤28 days prior to enrollment~flow cytometry: Day 1 of cycles 6, 12, 18 and at end of study.~laboratory biomarker analysis: ≤28 days prior to enrollment~quality-of-life assessment: Start of each cycle"
439050|NCT00520741|B3|Baseline|Total|Total of all reporting groups
439051|NCT00520741|B2|Baseline|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439052|NCT00520741|B1|Baseline|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439053|NCT00520741|P2|Participant Flow|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439054|NCT00520741|P1|Participant Flow|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439055|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439056|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439057|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439058|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439059|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439060|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439061|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3 :1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
439062|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439063|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439064|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439065|NCT00520741|O2|Outcome|Lacosamide 400 mg/Day|"Lacosamide (LCM) 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~This study had a single inferential test of the primary efficacy variable for the LCM 400 mg/day treatment arm which was to be compared to an external historical control. As such, no adjustment for multiplicity was required. Additional analyses of the primary efficacy variable for the LCM 400 mg/day and LCM 300 mg/day treatment arms was for exploratory or supportive purposes only. The analysis of the LCM 300 mg/day arm is exploratory due to the 3:1 randomization ratio. Therefore the LCM 300 mg/day arm is not reported for this Outcome Measure."
439066|NCT00520741|O1|Outcome|Lacosamide 300 mg/Day|"Lacosamide (LCM) 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439067|NCT00520741|E2|Reported Event|Lacosamide 400 mg/Day|"Lacosamide 400 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 200 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439068|NCT00520741|E1|Reported Event|Lacosamide 300 mg/Day|"Lacosamide 300 mg/day~Lacosamide : 50 mg and 100 mg tablets provided for 150 mg twice daily dosing for up to 20 weeks.~Subjects were randomized 3:1 to one of two therapeutic doses of Lacosamide, 400 mg/day or 300 mg/day, to ensure a study design comparable to the historical control."
439069|NCT00520676|B3|Baseline|Total|Total of all reporting groups
439070|NCT00520676|B2|Baseline|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439071|NCT00520676|B1|Baseline|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439072|NCT00520676|P2|Participant Flow|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439073|NCT00520676|P1|Participant Flow|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439074|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439075|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439076|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439077|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439078|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439079|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439080|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439081|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439082|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439083|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439084|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439085|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439086|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439087|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439088|NCT00520676|O2|Outcome|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439089|NCT00520676|O1|Outcome|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439090|NCT00520676|E2|Reported Event|Docetaxel Plus Carboplatin|docetaxel 75 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439091|NCT00520676|E1|Reported Event|Pemetrexed Plus Carboplatin|pemetrexed 500 mg/m^2 plus carboplatin AUC 5 mg*min/mL on Day 1 every 21 days
439092|NCT00520572|B7|Baseline|Total|Total of all reporting groups
439093|NCT00520572|B6|Baseline|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439094|NCT00520572|B5|Baseline|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439095|NCT00520572|B4|Baseline|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439096|NCT00520572|B3|Baseline|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439097|NCT00520572|B2|Baseline|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439098|NCT00520572|B1|Baseline|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439099|NCT00520572|P6|Participant Flow|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439100|NCT00520572|P5|Participant Flow|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439101|NCT00520572|P4|Participant Flow|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439102|NCT00520572|P3|Participant Flow|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439103|NCT00520572|P2|Participant Flow|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439104|NCT00520572|P1|Participant Flow|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439105|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439106|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439107|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439108|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439109|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439110|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439111|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439112|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439113|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439114|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439115|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439116|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439117|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439118|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439119|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439120|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439121|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439122|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439123|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439124|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439125|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439126|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439127|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439128|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439129|NCT00520572|O6|Outcome|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439130|NCT00520572|O5|Outcome|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439131|NCT00520572|O4|Outcome|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439132|NCT00520572|O3|Outcome|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439133|NCT00520572|O2|Outcome|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439134|NCT00520572|O1|Outcome|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439135|NCT00520572|E6|Reported Event|Etanercept|Etanercept 50 mg, subcutaneous injection, once weekly, open label
439136|NCT00520572|E5|Reported Event|Placebo|Placebo to AZD9056, oral tablets, once daily, double blinded
439137|NCT00520572|E4|Reported Event|AZD9056 400 mg|AZD9056 400 mg, oral tablets, once daily, double blinded
439138|NCT00520572|E3|Reported Event|AZD9056 200 mg|AZD9056 200 mg, oral tablets, once daily, double blinded
439139|NCT00520572|E2|Reported Event|AZD9056 100 mg|AZD9056 100 mg, oral tablets, once daily, double blinded
439140|NCT00520572|E1|Reported Event|AZD9056 50 mg|AZD9056 50 mg, oral tablets, once daily, double blinded
439141|NCT00520546|B1|Baseline|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
439142|NCT00520546|P1|Participant Flow|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
439143|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
439197|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439198|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439144|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
439145|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
439146|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
439147|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
439148|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
439149|NCT00520546|O3|Outcome|PET/MRI|PET images at 45 min p.i. and 65 min p.i. (post injection) were fused with transversal endorectal and QBody T2w MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
439150|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2w TSE transversal and a coronal STIR sequence. For prostate assessment, 3mm endorectal T2w SE sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
439151|NCT00520546|O1|Outcome|FEC-PET|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
439152|NCT00520546|O3|Outcome|PositronEmissionTomography/MagneticResonanceImaging (PET/MRI)|PET images at 45 min p.i. (post injection) and 65 min p.i. were fused with transversal endorectal and QBody T2 weighed (T2w) MRI images by using Hermes Medical Solutions Multi Modality landmark fusion tool. The four PET/MRI spot markers served as references. Without any patient movement between both modalities the fused images fitted exactly.
439153|NCT00520546|O2|Outcome|Magnetic Resonance Imaging (MRI)|The MRI examination was performed on a 1.5Tesla MRI system (Gyroscan ACS-NT, Philips, Hamburg, Germany) with combined QBody and endorectal coil. Pelvic assessment and lymph node staging was effected with 5mm T2 weighted (T2w) turbo spin echo (TSE) transversal and a coronal short-tau inversion recovery (STIR) sequence. For prostate assessment, 3mm endorectal T2 weighed (T2w) spin echo (SE) sagittal, transversal and coronal sequences were acquired. Transversal sequences were angulated 90° to intraprostatic bladder catheter to allow exact correlation with histological holoptical slices.
439154|NCT00520546|O1|Outcome|[18F]Fluoroethylcholine Positron-Emission-Tomography (FEC-PET)|"PET scans were performed on a LSO scanner (ECAT ACCEL, Siemens, Erlangen, Germany) by using a multiphase protocol starting with a cold transmission scan of the lower pelvis. This was followed by a list mode emission scan with 10 frames à 1 minute starting immediately after the administration of 3.3MBq [18F]Fluoroethylcholine chloride (FEC; Eckert & Ziegler EURO-PET Berlin GmbH) as a bolus through the cubital vein. Acquisition parameters were 3 minutes emission scan and 2 minutes transmission scan for each bed position. Therefore the prostate region was scanned again at 45 minutes p.i. (post injection) A delayed local acquisition at 65 minutes over the lower pelvis with 6 minutes emission and 2 minutes transmission finished the diagnostic acquisition procedure."
439199|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439200|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439201|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439770|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439155|NCT00520546|E1|Reported Event|FEC-PET/eMRI|The day before surgery, fasting patients received a bladder catheter right before Positron-Emission-Tomography/ Magnetic Resonance Imaging (PET/MRI) examination to avoid different sizes of the urinary bladder in PET and MRI scan and to reduce bladder FEC-activity overlay of the prostate. After applying the endorectal MRI coil patients were positioned in a vacuum mattress on MRI table. Additionally, 4 PET/MRI multimodality spot markers containing 37kBq [22Na] and a MRI T2w (T2 weighed) hyperintense gel were attached at the hip region to allow landmark PET/MRI fusion. After MRI acquisition the modular MRI table was fixed on the PET table system. Patients kept in the same position during the whole procedure. PET scans were performed by using a multiphase protocol starting with a list mode emission scan immediately after the administration of 3.3MBq [18F]fluoroethylcholine (FEC) as a bolus through the cubital vein.
439156|NCT00519818|B1|Baseline|Cortef Then Chronocort|Hydrocortisone immediate release 3 times daily total dose 30mg for 7 days, then hydrocortisone modified release tablet 30mg once nightly for 28days
439157|NCT00519818|P1|Participant Flow|Cortef Then Chronocort|Hydrocortisone immediate release tablet treatment then Modified release hydrocortisone
439158|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
439159|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
439160|NCT00519818|O2|Outcome|Chronocort|Hydrocortisone modified release tablet treatment
439161|NCT00519818|O1|Outcome|Cortef|Hydrocortisone immediate release tablet
439162|NCT00519818|E2|Reported Event|Cortef|Hydrocortisone immediate release tablet
439163|NCT00519818|E1|Reported Event|Chronocort|Hydrocortisone modified release tablet
439164|NCT00519779|B3|Baseline|Total|Total of all reporting groups
439165|NCT00519779|B2|Baseline|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439166|NCT00519779|B1|Baseline|Placebo|Placebo oral Omega-3 fish oil supplementation
439167|NCT00519779|P2|Participant Flow|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439168|NCT00519779|P1|Participant Flow|Placebo|Placebo oral Omega-3 fish oil supplementation
439169|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439170|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439171|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439172|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439173|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439174|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439175|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439176|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439177|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439178|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439179|NCT00519779|O2|Outcome|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439180|NCT00519779|O1|Outcome|Placebo|Placebo oral Omega-3 fish oil supplementation
439181|NCT00519779|E2|Reported Event|Omega-3 Fish Oil Supplement|oral Omega-3 fish oil supplementation, 2.496 grams of omega-3/day (2085 mg of eicosapentaenoic acid [EPA] and 348 mg of docosahexaenoic acid [DHA])
439182|NCT00519779|E1|Reported Event|Placebo|Placebo oral Omega-3 fish oil supplementation
439183|NCT00519649|B1|Baseline|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439184|NCT00519649|P1|Participant Flow|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439185|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439186|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439187|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439188|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439189|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439190|NCT00519649|O1|Outcome|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439191|NCT00519649|E1|Reported Event|Group Engerix|Subjects received a single challenge dose of Engerix™ (hepatitis-B [HBV] vaccine)
439192|NCT00520494|B1|Baseline|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439193|NCT00520494|P1|Participant Flow|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439194|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439195|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439196|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439202|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439203|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439204|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439205|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439206|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439207|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439208|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439209|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439210|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439211|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439212|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439213|NCT00520494|O1|Outcome|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439214|NCT00520494|E1|Reported Event|Vivaglobin|Vivaglobin: 16% (160 mg/mL) liquid formulation of human IgG for SC use. Loading dose: 100 mg/kg for 5 consecutive days; maintenance dose: 100 mg/kg 1 to 2 times a week for 24 weeks.
439215|NCT00520468|B1|Baseline|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
439216|NCT00520468|P1|Participant Flow|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
439217|NCT00520468|O1|Outcome|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
439218|NCT00520468|E1|Reported Event|Cytokine-Immunotherapy|Erythropoietin 40,000 units subcutaneously (SQ) weekly; G-CSF 300 mcg SQ twice per week; Prednisone 60 mg/Day for 7 days, taper over 1 month; Cyclosporin A 300 mg orally daily
439219|NCT00520403|B1|Baseline|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439220|NCT00520403|P1|Participant Flow|Bevacizumab + Interferon Alfa-2a (IFN)/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg intravenously (IV) and bevacizumab 15 milligrams per kilogram (mg/kg) IV on Day 1 followed by 2 weeks off and IFN subcutaneous (SC) injection three times per week (starting on Day 1) at doses of 3 million International Units (mIU) (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3; the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439221|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439238|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439239|NCT00520351|E2|Reported Event|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439222|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439223|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439224|NCT00520403|O1|Outcome|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439225|NCT00520403|E1|Reported Event|Bevacizumab + IFN/Vinblastine|"Cycle 1 (3-week cycle): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN SC injection three times per week (starting on Day 1) at doses of 3 mIU (Week 1), 9 mIU (Week 2), and 18 mIU (Week 3).~Cycles 2 to 17 (3-week cycles): Participants received vinblastine sulfate 0.1 mg/kg IV and bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off and IFN 18 mIU SC injection three times per week during Weeks 1 through 3 (starting on Day 1); the cycle was repeated every 3 weeks up to Week 51 (Cycle 17) or to tumor progression.~If the first 17 cycles were tolerated without tumor progression, participants received bevacizumab monotherapy: bevacizumab 15 mg/kg IV on Day 1 followed by 2 weeks off; this cycle was repeated every 3 weeks up to Week 102 (Cycle 34) or to tumor progression."
439226|NCT00520351|B3|Baseline|Total|Total of all reporting groups
439227|NCT00520351|B2|Baseline|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439228|NCT00520351|B1|Baseline|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439229|NCT00520351|P2|Participant Flow|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439230|NCT00520351|P1|Participant Flow|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439231|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439232|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439233|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439234|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439235|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439236|NCT00520351|O1|Outcome|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439237|NCT00520351|O2|Outcome|Optifree Replenish First, Then ClearCare|In Period 1, participants used Optifree Replenish contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use ClearCare solution. In the first intervention, participants were randomly assigned to use Optifree Replenish first.
439449|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439240|NCT00520351|E1|Reported Event|ClearCare First, Then Optifree Replenish|In Period 1, participants used ClearCare contact lens solution. There was a washout period of 2-3 days. Participants were then assigned to use OptifreeReplenish solution. In the first intervention participants were randomly assigned to use ClearCare first.
439241|NCT00520234|B3|Baseline|Total|Total of all reporting groups
439242|NCT00520234|B2|Baseline|Placebo|Normal Saline 100 cc IV daily
439243|NCT00520234|B1|Baseline|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
439244|NCT00520234|P2|Participant Flow|Placebo|Normal Saline 100 cc IV daily
439245|NCT00520234|P1|Participant Flow|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
439246|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
439247|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
439248|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
439249|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
439250|NCT00520234|O2|Outcome|Placebo|Normal Saline 100 cc IV daily
439251|NCT00520234|O1|Outcome|Prophylaxis|Caspofungin 50mg IV daily
439252|NCT00520234|E2|Reported Event|Placebo|Normal Saline 100 cc IV daily
439253|NCT00520234|E1|Reported Event|Prophylaxis|Caspofungin 50 mg IV daily up to 28 days of therapy
439254|NCT00520013|B4|Baseline|Total|Total of all reporting groups
439255|NCT00520013|B3|Baseline|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None~bevacizumab~paclitaxel~carboplatin"
439256|NCT00520013|B2|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year.~bevacizumab~erlotinib~paclitaxel~carboplatin"
439257|NCT00520013|B1|Baseline|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year.~bevacizumab~paclitaxel~carboplatin"
439258|NCT00520013|P3|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation: None"
439259|NCT00520013|P2|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
439260|NCT00520013|P1|Participant Flow|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
439261|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
439262|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
439263|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
439264|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
439265|NCT00520013|O2|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
439266|NCT00520013|O1|Outcome|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
439267|NCT00520013|E2|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab/Erlotinib|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (AE): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle and oral erlotinib 150mg daily for 1 year."
439268|NCT00520013|E1|Reported Event|Carboplatin/Paclitaxel/Bevacizumab Then Bevacizumab|"Induction (CTA): Patients received carboplatin IV AUC 5, paclitaxel IV 175 mg/m2 and bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 6 cycles. Bevacizumab started with cycle 2.~Patients with disease progression based on radiographic evaluation after induction could not advance to the randomized consolidation phase.~Consolidation (A): Patients received bevacizumab IV 15 mg/kg on day 1 (+/- 3d) of a 21 day cycle for 1 year."
439269|NCT00519636|B5|Baseline|Total|Total of all reporting groups
439270|NCT00519636|B4|Baseline|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
439271|NCT00519636|B3|Baseline|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439272|NCT00519636|B2|Baseline|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
439273|NCT00519636|B1|Baseline|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439274|NCT00519636|P4|Participant Flow|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
439275|NCT00519636|P3|Participant Flow|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439276|NCT00519636|P2|Participant Flow|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
439277|NCT00519636|P1|Participant Flow|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439278|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
439279|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439280|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439281|NCT00519636|O3|Outcome|Total|All Subjects on both arms preference.
439282|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439283|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439284|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
439285|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439286|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439287|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
439288|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439289|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
439346|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439771|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439290|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439291|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
439292|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439293|NCT00519636|O2|Outcome|Placebo FF/FP|Subjects who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
439294|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439295|NCT00519636|O3|Outcome|Total|All subjects on both arms preference.
439296|NCT00519636|O2|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439297|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439298|NCT00519636|O4|Outcome|Placebo FP/FF|Subjects who received no active drug but believed they were following the Fluticasone propionate/Fluticasone Furoate group.
439299|NCT00519636|O3|Outcome|Fluticasone Propionate NS/Fluticasone Furoate NS|Subjects who received Fluticasone Propionate Nasal Spray (FPNS)110 mcg QD followed by Fluticasone Furoate Nasal Spray (FFNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FFNS 110 mcg QD, followed by FPNS 200 mcg QD.
439300|NCT00519636|O2|Outcome|Placebo FF/FP|Subject who received no active drug but believed they were following the Fluticasone Furoate/Fluticasone Propionate group.
439301|NCT00519636|O1|Outcome|Fluticasone Furoate NS/Fluticasone Propionate NS|Subjects who received Fluticasone Furoate Nasal Spray(FFNS)110 mcg QD followed by Fluticasone Propionate Nasal Spray (FPNS) 200 mcg QD for one week(treatment 1), followed by a 7 day washout period, and switched to one week of treatment 2, given FPNS 110 mcg QD, followed by FFNS 200 mcg QD.
439302|NCT00519636|E4|Reported Event|Placebo -FP|Subject who took no active drug but believed they were on Fluticasone Propionate Nasal Spray.
439303|NCT00519636|E3|Reported Event|Placebo - FF|Subjects who took no active drug but believed they were on Fluticasone Furoate Nasal Spray.
439304|NCT00519636|E2|Reported Event|Fluticasone Propionate Nasal Spray|Subjects who receive Fluticasone Propionate Nasal Spray.
439305|NCT00519636|E1|Reported Event|Fluticasone Furoate Nasal Spray|Subjects who received Fluticasone Furoate.
439306|NCT00519623|B1|Baseline|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
439307|NCT00519623|P1|Participant Flow|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
439308|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
439309|NCT00519623|O1|Outcome|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
439310|NCT00519623|E1|Reported Event|Transdermal Patch|PassPort(r) Transdermal Insulin Delivery System
439311|NCT00519532|B1|Baseline|Rotigotine|Rotigotine Transdermal Patch
439312|NCT00519532|P1|Participant Flow|Rotigotine|Rotigotine Transdermal Patch
439313|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
439314|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
439315|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
439316|NCT00519532|O1|Outcome|Rotigotine|Rotigotine Transdermal Patch
439317|NCT00519532|E1|Reported Event|Rotigotine|Rotigotine Transdermal Patch
439318|NCT00519376|B1|Baseline|GW642444M(25,50 and 100 µg),GW642444H(100 µg), PB in 1-16 Seq|Participants were administered single dose of four of the five following treatments: GW642444M (25, 50 and 100 µg), GW642444H (100 µg) or placebo. Each participant received doses of GW642444M in an ascending dose manner with GW642444H and placebo randomly interspersed as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439319|NCT00519376|P16|Participant Flow|Seq 16: GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439320|NCT00519376|P15|Participant Flow|Seq 15: GW642444H 100 µg, GW642444M 25 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, GW642444M 25 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439321|NCT00519376|P14|Participant Flow|Seq 14: GW642444H 100 µg, PB, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444H 100 µg, Placebo, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439322|NCT00519376|P13|Participant Flow|Seq 13: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439772|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439323|NCT00519376|P12|Participant Flow|Seq 12: GW642444M 25 µg, GW642444H 100 µg, PB, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444H 100 µg, Placebo, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439324|NCT00519376|P11|Participant Flow|Seq 11: PB, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444H 100 µg, GW642444M 25 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439325|NCT00519376|P10|Participant Flow|Seq 10: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439326|NCT00519376|P9|Participant Flow|Seq 9: GW642444M 25 µg, PB, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439327|NCT00519376|P8|Participant Flow|Seq 8: PB, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444H 100 µg, GW642444M 50 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439328|NCT00519376|P7|Participant Flow|Seq 7: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439329|NCT00519376|P6|Participant Flow|Seq 6: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439330|NCT00519376|P5|Participant Flow|Seq 5: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg|Participants were administered single dose of the following treatments: Placebo, GW642444M 25 µg, GW642444M 50 µg, GW642444H 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439331|NCT00519376|P4|Participant Flow|Seq 4: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, PB|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg, Placebo. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439332|NCT00519376|P3|Participant Flow|Seq 3: GW642444M 25 µg, GW642444M 50 µg, PB, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, GW642444M 50 µg, Placebo, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439333|NCT00519376|P2|Participant Flow|Seq 2: GW642444M 25 µg, PB, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: GW642444M 25 µg, Placebo, GW642444M 50 µg, GW642444M 100 µg. Each participant received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439334|NCT00519376|P1|Participant Flow|Seq 1: PB, GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg|Participants were administered single dose of the following treatments: Placebo (PB), GW642444M 25 µg, GW642444M 50 µg, GW642444M 100 µg. Each participants received doses in an ascending dose manner as per randomization from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439335|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439336|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439337|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439338|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439339|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439340|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439341|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439342|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439343|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439344|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439345|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439773|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439347|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439348|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439349|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439350|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439351|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439352|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439353|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439354|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439355|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439356|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439357|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439358|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439359|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439360|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439361|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439362|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439363|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439364|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439365|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439366|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439367|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439368|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439369|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439370|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439371|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439372|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439373|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439374|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439375|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439376|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439377|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439378|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439379|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439380|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439774|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439381|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439382|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439383|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439384|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439385|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439386|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439387|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439388|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439389|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439390|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439391|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439392|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439393|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439394|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439395|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439396|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439397|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439398|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439399|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439400|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439401|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439402|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439403|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439404|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439405|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439406|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439407|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439408|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439409|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439410|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439411|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439412|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439413|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439414|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439775|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439415|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439416|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439417|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439418|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439419|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439420|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439421|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439422|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439423|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439424|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439425|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439426|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439427|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439428|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439429|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439430|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439431|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439432|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439433|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439434|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439435|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439436|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439437|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439438|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439439|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439440|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439441|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439442|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439443|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439444|NCT00519376|O1|Outcome|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439445|NCT00519376|O5|Outcome|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439446|NCT00519376|O4|Outcome|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439447|NCT00519376|O3|Outcome|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439448|NCT00519376|O2|Outcome|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
445464|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
439450|NCT00519376|E5|Reported Event|GW642444H 100 µg|Participants received GW642444H 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439451|NCT00519376|E4|Reported Event|GW642444M 100 µg|Participants received GW642444M 100 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439452|NCT00519376|E3|Reported Event|GW642444M 50 µg|Participants received GW642444M 50 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439453|NCT00519376|E2|Reported Event|GW642444M 25 µg|Participants received GW642444M 25 µg single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439454|NCT00519376|E1|Reported Event|Placebo|Participants received placebo single dose in the morning from the dry powder inhaler (DPI) from the DISKUS/ACCUHALER (one inhalation in the morning).
439455|NCT00519285|B3|Baseline|Total|Total of all reporting groups
439456|NCT00519285|B2|Baseline|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439457|NCT00519285|B1|Baseline|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439458|NCT00519285|P2|Participant Flow|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439459|NCT00519285|P1|Participant Flow|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439460|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439461|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439462|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439463|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439464|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439465|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439466|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439467|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439468|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439469|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439470|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439471|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439472|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439473|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439474|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439475|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439476|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439477|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439478|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439479|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439480|NCT00519285|O2|Outcome|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439481|NCT00519285|O1|Outcome|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439482|NCT00519285|E2|Reported Event|Aflibercept|Aflibercept, 6 mg/kg 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439483|NCT00519285|E1|Reported Event|Placebo|Placebo, 1 hour IV, immediately followed by docetaxel, 75 mg/m² 1 hour IV, every 3 weeks in combination with oral prednisone or prednisolone, 5 mg PO twice daily
439484|NCT00519194|B1|Baseline|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
439485|NCT00519194|P1|Participant Flow|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral,aortic, and or tricuspid valve surgery, PFO closure or CABG procedure"
439486|NCT00519194|O1|Outcome|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
439487|NCT00519194|E1|Reported Event|Epicor Cardiac Ablation|"Epicor LP Cardiac Ablation System: Surgical ablation of permanent AF during concomitant open chest and/or open heart surgery~Surgical ablation of permanent AF: Concomitant AF ablation during mitral valve surgery"
439488|NCT00519090|B3|Baseline|Total|Total of all reporting groups
439489|NCT00519090|B2|Baseline|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
439490|NCT00519090|B1|Baseline|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
439491|NCT00519090|P2|Participant Flow|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
439492|NCT00519090|P1|Participant Flow|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
439493|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
439494|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
439495|NCT00519090|O2|Outcome|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
439496|NCT00519090|O1|Outcome|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
439497|NCT00519090|E2|Reported Event|Imatinib|Patients received 400 mg twice daily. Capsules were available in 100 mg and 400 mg formulations.
439498|NCT00519090|E1|Reported Event|Nilotinib (AMN107)|Patients received 400 mg twice daily, 2 x 200 mg capsules twice daily.
439499|NCT00519077|B1|Baseline|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
439500|NCT00519077|P1|Participant Flow|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
439501|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
439502|NCT00519077|O1|Outcome|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
439503|NCT00519077|E1|Reported Event|Gefitinib|Patients were started on gefitinib 250 mg orally daily for 2 weeks. At 2 weeks, patients were reevaluated and given skin toxicity grade according to the National Cancer Institute Common Toxicity Criteria version 3.0 (CTC 3.0). Patients with grade 2 or greater skin toxicity remained on 250 mg daily; in patients with grade 0-1 skin toxicity the dose 250-mg oral dose-escalating dose; each patient received treatment at the dose that produced grade 2 skin toxicity until disease progression or withdrawal.
439504|NCT00518986|B3|Baseline|Total|Total of all reporting groups
439505|NCT00518986|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439506|NCT00518986|B1|Baseline|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439507|NCT00518986|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439776|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439777|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439508|NCT00518986|P1|Participant Flow|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439509|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439510|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439511|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439512|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439513|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439514|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439515|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439516|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439517|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439518|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439519|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439520|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
445465|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
439521|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439522|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439523|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439524|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439525|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439526|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439527|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439528|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439529|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439530|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439531|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439532|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439651|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439778|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439779|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
445466|NCT00502775|O1|Outcome|Placebo|
439533|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439534|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439535|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439536|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439537|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439538|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439539|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439540|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439541|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439542|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439543|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439544|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439652|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439780|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439781|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
445467|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
439545|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439546|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439547|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439548|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439549|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439550|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439551|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439552|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439553|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439554|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439555|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439556|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439653|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439782|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439783|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439557|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439558|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439559|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439560|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439561|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439562|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439563|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439564|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439565|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439566|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439567|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439568|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439654|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439784|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439785|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
445468|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
439569|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439570|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439571|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439572|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439573|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439574|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439575|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439576|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439577|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439578|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439579|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439580|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439655|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439786|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439787|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
445469|NCT00502775|O1|Outcome|Placebo|
439581|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439582|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439583|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439584|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439585|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439586|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439587|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439588|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439589|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439590|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439591|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439592|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439656|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439788|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439789|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
445470|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
439593|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439594|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439595|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439596|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439597|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439598|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439599|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439600|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439601|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439602|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439603|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439604|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439657|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439790|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439791|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439605|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439606|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439607|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439608|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439609|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439610|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439611|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439612|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439613|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439614|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439615|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439616|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439658|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439792|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439793|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
445471|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
439617|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439618|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439619|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439620|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439621|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439622|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439623|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439624|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439625|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439626|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439627|NCT00518986|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439628|NCT00518986|O1|Outcome|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439659|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439794|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439795|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
445472|NCT00502775|O1|Outcome|Placebo|
439629|NCT00518986|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for both the placebo run in period and the double blind treatment period. Study drug was titrated to a target dosage of 4 tablets/day for each patient. Dosing began at 1 tablet/day in the morning on Day 1, and then increased by 1 tablet on days 2, 5, and 8 to target dose of 4 tablets. If deemed appropriate by investigator, dose could be further titrated to 5 tablets. If tolerability issues arose, dose could be decreased in 1 tablet increments anytime after 4 tablets/day dose was achieved.
439630|NCT00518986|E1|Reported Event|Armodafinil 200 mg/Day|Armodafinil (or placebo) was titrated to a target dosage of 200 mg/day (4 tablets) for each patient. Dosing began at 50 mg (1 tablet)/day each morning on Day 1, and then increased by 50 mg (1 tablet) on days 2, 5, and 8 to target dose of 200 mg/day (4 tablets). If deemed appropriate by investigator, dose could be further titrated to 250 mg/day (5 tablets). If tolerability issues arose, dose could be decreased in 50 mg increments anytime after 200 mg/day dose was achieved.
439631|NCT00518882|B3|Baseline|Total|Total of all reporting groups
439632|NCT00518882|B2|Baseline|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439633|NCT00518882|B1|Baseline|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439634|NCT00518882|P2|Participant Flow|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439635|NCT00518882|P1|Participant Flow|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439636|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439637|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439638|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439639|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439640|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439641|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439642|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439643|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439644|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439645|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439646|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439647|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439648|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439649|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439650|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439761|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439762|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439660|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439661|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439662|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439663|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439664|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439665|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439666|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439667|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439668|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439669|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439670|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439671|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439672|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439673|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439674|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439675|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439676|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439677|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439678|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439679|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439680|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439681|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439682|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439763|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439764|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439683|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439684|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439685|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439686|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439687|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439688|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439689|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439690|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439691|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439692|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439693|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439694|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439695|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439696|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439697|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439698|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439699|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439700|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439701|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439702|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439703|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439704|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439705|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439765|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439766|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439706|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439707|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439708|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439709|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439710|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439711|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439712|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439713|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439714|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439715|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439716|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439717|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439718|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439719|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439720|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439721|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439722|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439723|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439724|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439725|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439726|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439727|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439728|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439767|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439768|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439729|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439730|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439731|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439732|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439733|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439734|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439735|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439736|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439737|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439738|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439739|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439740|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439741|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439742|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439743|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439744|NCT00518882|O2|Outcome|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439745|NCT00518882|O1|Outcome|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439746|NCT00518882|E2|Reported Event|Exenatide -> Liraglutide -> Liraglutide|Exenatide 10 mcg twice daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) switched to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439747|NCT00518882|E1|Reported Event|Liraglutide -> Liraglutide -> Liraglutide|Liraglutide 1.8 mg once daily + OAD (metformin monotherapy, sulphonylurea (SU) monotherapy or a combination), Weeks 0-26 (double-blinded) continued to receive liraglutide 1.8 mg once daily + OAD in extension period (weeks 26-52 and 52-78)
439748|NCT00518713|B5|Baseline|Total|Total of all reporting groups
439749|NCT00518713|B4|Baseline|Placebo|tablets; orally; daily for 15-18 weeks
439750|NCT00518713|B3|Baseline|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439751|NCT00518713|B2|Baseline|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439752|NCT00518713|B1|Baseline|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439753|NCT00518713|P4|Participant Flow|Placebo|tablets; orally; daily for 15-18 weeks
439754|NCT00518713|P3|Participant Flow|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439755|NCT00518713|P2|Participant Flow|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439756|NCT00518713|P1|Participant Flow|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439757|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439758|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439759|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439760|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439796|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439797|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439798|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439799|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439800|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439801|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439802|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439803|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439804|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439805|NCT00518713|O4|Outcome|Placebo|tablets; orally; daily for 15-18 weeks
439806|NCT00518713|O3|Outcome|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439807|NCT00518713|O2|Outcome|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439808|NCT00518713|O1|Outcome|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439809|NCT00518713|E4|Reported Event|Placebo|tablets; orally; daily for 15-18 weeks
439810|NCT00518713|E3|Reported Event|Clobazam High Dose|1.0 mg/kg/day; tablets; orally; for 15-18 weeks
439811|NCT00518713|E2|Reported Event|Clobazam Medium Dose|0.5 mg/kg/day; tablets; orally; for 15-18 weeks
439812|NCT00518713|E1|Reported Event|Clobazam Low Dose|0.25 mg/kg/day; tablets; orally; for 15-18 weeks
439813|NCT00518687|B3|Baseline|Total|Total of all reporting groups
439814|NCT00518687|B2|Baseline|Placebo|Placebo : 0.5-ml single injection of matching placebo
439815|NCT00518687|B1|Baseline|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439816|NCT00518687|P2|Participant Flow|Placebo|Placebo : 0.5-ml single injection of matching placebo
439817|NCT00518687|P1|Participant Flow|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439818|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
439819|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439820|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
439821|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439822|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
439823|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439824|NCT00518687|O2|Outcome|Placebo|Placebo : 0.5-ml single injection of matching placebo
439825|NCT00518687|O1|Outcome|V710 60 µg|V710: 0.5-ml single injection of V710 (60 µg)
439826|NCT00518687|E2|Reported Event|Placebo|Placebo : 0.5-ml single injection of matching placebo
439827|NCT00518687|E1|Reported Event|V710 (60 µg) Lyophilized|V710: 0.5-ml single injection of V710 (60 µg)
439828|NCT00518622|B9|Baseline|Total|Total of all reporting groups
439829|NCT00518622|B8|Baseline|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
439830|NCT00518622|B7|Baseline|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
439831|NCT00518622|B6|Baseline|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
439832|NCT00518622|B5|Baseline|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439833|NCT00518622|B4|Baseline|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439834|NCT00518622|B3|Baseline|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439835|NCT00518622|B2|Baseline|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439836|NCT00518622|B1|Baseline|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439837|NCT00518622|P8|Participant Flow|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
439838|NCT00518622|P7|Participant Flow|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
439839|NCT00518622|P6|Participant Flow|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
439840|NCT00518622|P5|Participant Flow|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439841|NCT00518622|P4|Participant Flow|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439842|NCT00518622|P3|Participant Flow|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439843|NCT00518622|P2|Participant Flow|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439844|NCT00518622|P1|Participant Flow|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439845|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
439846|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
439847|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
439848|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439849|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439850|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439851|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439852|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439853|NCT00518622|O8|Outcome|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
439854|NCT00518622|O7|Outcome|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
439855|NCT00518622|O6|Outcome|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
439856|NCT00518622|O5|Outcome|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439857|NCT00518622|O4|Outcome|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439858|NCT00518622|O3|Outcome|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439859|NCT00518622|O2|Outcome|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439860|NCT00518622|O1|Outcome|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439861|NCT00518622|E8|Reported Event|Placebo|Patients received an oral dose of matching placebo twice a day 9 (b.i.d.) for 7 days and on the morning of Day 8.
439862|NCT00518622|E7|Reported Event|600 mg q.d. MK7009|Patients received an oral dose of 600 mg MK7009 in the morning (q.d.) and an oral dose of matching placebo in the evening for 7 days. Patients received 600 mg of MK7009 on the morning of Day 8.
439863|NCT00518622|E6|Reported Event|125 mg q.d. MK7009|"Patients received an oral dose of 125 mg MK7009 in the morning (once a day (q.d.)) and an oral dose of matching placebo in the evening for 7 days.~Patients received 125 mg of MK7009 on the morning of Day 8."
439864|NCT00518622|E5|Reported Event|700 mg b.i.d. MK7009|Patients received an oral dose of 700 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439865|NCT00518622|E4|Reported Event|500 mg b.i.d. MK7009|Patients received an oral dose of 500 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439866|NCT00518622|E3|Reported Event|250 mg b.i.d. MK7009|Patients received an oral dose of 250 mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439867|NCT00518622|E2|Reported Event|75 mg b.i.d. MK7009|Patients received an oral dose of 75mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439868|NCT00518622|E1|Reported Event|25 mg b.i.d. MK7009|Patients received an oral dose of 25mg MK7009 twice a day (b.i.d.) for 7 days and on the morning of Day 8.
439869|NCT00518531|B3|Baseline|Total|Total of all reporting groups
439870|NCT00518531|B2|Baseline|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
439871|NCT00518531|B1|Baseline|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
439872|NCT00518531|P2|Participant Flow|Denosumab in Period 1 Then Alendronate in Period 2|Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 1) followed by Alendronate 70 mg orally once a week for 1 year (treatment period 2).
439873|NCT00518531|P1|Participant Flow|Alendronate in Period 1 Then Denosumab in Period 2|Alendronate 70 mg orally once a week (QW) for 1 year (treatment period 1) followed by Denosumab 60 mg subcutaneously every 6 months for 1 year (treatment period 2).
439874|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439875|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439876|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439877|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439878|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439879|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439880|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439881|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439882|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439883|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439884|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439885|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439886|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439887|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439888|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439889|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439890|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439891|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439892|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439893|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439894|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439895|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439896|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439897|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439898|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439899|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439900|NCT00518531|O2|Outcome|Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months for 1 year.
439901|NCT00518531|O1|Outcome|Alendronate|Participants received alendronate 70 mg orally once a week for 1 year.
439902|NCT00518531|E4|Reported Event|Treatment Period 2: Denosumab|Participants who received alendronate 70 mg orally once a week in year 1 then received denosumab 60 mg subcutaneously every 6 months in year 2.
439903|NCT00518531|E3|Reported Event|Treatment Period 2: Alendronate|Participants who received denosumab 60 mg subcutaneously every 6 months in year 1 then received alendronate 70 mg orally once a week in year 2.
439904|NCT00518531|E2|Reported Event|Treatment Period 1: Denosumab|Participants received denosumab 60 mg subcutaneously every 6 months in year 1.
439905|NCT00518531|E1|Reported Event|Treatment Period 1: Alendronate|Participants received alendronate 70 mg orally once a week in year 1.
439906|NCT00518336|B3|Baseline|Total|Total of all reporting groups
439907|NCT00518336|B2|Baseline|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439908|NCT00518336|B1|Baseline|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439909|NCT00518336|P2|Participant Flow|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439910|NCT00518336|P1|Participant Flow|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439911|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439912|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439913|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439914|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439915|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439916|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439917|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439918|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439919|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439920|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439921|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440426|NCT00518011|E1|Reported Event|Gemcitabine|Participants received Gemcitabine (1000 mg/m^2/day), IV on Days 1, 8, 15 of each 4 week cycle for 6 cycles
439922|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439923|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439924|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439925|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439926|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439927|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439928|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439929|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439930|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439931|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439932|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439933|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439934|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439935|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439936|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439937|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439938|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439939|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439940|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439941|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439942|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440113|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
439943|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439944|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439945|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439946|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439947|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439948|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439949|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439950|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439951|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439952|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439953|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439954|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439955|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439956|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439957|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439958|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439959|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439960|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439961|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439962|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439963|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440114|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440427|NCT00517933|B3|Baseline|Total|Total of all reporting groups
439964|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439965|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439966|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439967|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439968|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439969|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439970|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439971|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439972|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439973|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439974|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439975|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439976|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439977|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439978|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439979|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439980|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439981|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439982|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439983|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439984|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440115|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
439985|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439986|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439987|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439988|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439989|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439990|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439991|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439992|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439993|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439994|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439995|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439996|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439997|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439998|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
439999|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440000|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440001|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440002|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440003|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440004|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440005|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440116|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440428|NCT00517933|B2|Baseline|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440006|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440007|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440008|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440009|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440010|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440011|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440012|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440013|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440014|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440015|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440016|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440017|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440018|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440019|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440020|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440021|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440022|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440023|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440024|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440025|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440026|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440117|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440027|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440028|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440029|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440030|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440031|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440032|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440033|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440034|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440035|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440036|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440037|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440038|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440039|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440040|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440041|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440042|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440043|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440044|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440045|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440046|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440047|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440118|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
445473|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
440048|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440049|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440050|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440051|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440052|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440053|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440054|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440055|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440056|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440057|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440058|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440059|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440060|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440061|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440062|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440063|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440064|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440065|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440066|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440067|NCT00518336|O2|Outcome|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440068|NCT00518336|O1|Outcome|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440119|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440069|NCT00518336|E2|Reported Event|Placebo Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of placebo at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440070|NCT00518336|E1|Reported Event|Cervarix Group|Young adult women from the Brazilian cohort who participated in the primary study 580299/001 (NCT00689741) and follow-up study 580299/007 (NCT00120848) and received 3 doses of Cervarix at 0, 1 and 6 months intramuscularly into the deltoid region of the non-dominant arm during the primary study.
440071|NCT00518323|B5|Baseline|Total|Total of all reporting groups
440072|NCT00518323|B4|Baseline|Placebo|
440073|NCT00518323|B3|Baseline|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440074|NCT00518323|B2|Baseline|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440075|NCT00518323|B1|Baseline|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440076|NCT00518323|P4|Participant Flow|Placebo|
440077|NCT00518323|P3|Participant Flow|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440078|NCT00518323|P2|Participant Flow|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440079|NCT00518323|P1|Participant Flow|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440080|NCT00518323|O4|Outcome|Placebo|
440081|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440082|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440083|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440084|NCT00518323|O4|Outcome|Placebo|
440085|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440086|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440087|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440088|NCT00518323|O4|Outcome|Placebo|
440089|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440090|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440091|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440092|NCT00518323|O4|Outcome|Placebo|
440093|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440094|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440095|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440096|NCT00518323|O4|Outcome|Placebo|
440097|NCT00518323|O3|Outcome|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440098|NCT00518323|O2|Outcome|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440099|NCT00518323|O1|Outcome|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440100|NCT00518323|E4|Reported Event|Placebo|
440101|NCT00518323|E3|Reported Event|Pali ER High|Paliperidone ER 6 mg (for subjects weighing between 29 kg and less than 51 kg) or 12 mg (for subjects weighing 51 kg and above)
440102|NCT00518323|E2|Reported Event|Pali ER Medium|Paliperidone ER 3 mg (for subjects weighing between 29 kg and less than 51 kg) or 6 mg (for subjects weighing 51 kg and above)
440103|NCT00518323|E1|Reported Event|Pali ER Low|Paliperidone ER 1.5 mg for subjects weighing 29 kg and above
440104|NCT00518284|B5|Baseline|Total|Total of all reporting groups
440105|NCT00518284|B4|Baseline|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440106|NCT00518284|B3|Baseline|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440107|NCT00518284|B2|Baseline|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440108|NCT00518284|B1|Baseline|Control|Following revascularization, participants did not receive any study drug treatment.
440109|NCT00518284|P4|Participant Flow|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440110|NCT00518284|P3|Participant Flow|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440111|NCT00518284|P2|Participant Flow|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440112|NCT00518284|P1|Participant Flow|Control|Following revascularization, participants did not receive any study drug treatment.
440120|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440521|NCT00517751|B1|Baseline|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440121|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440122|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440123|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440124|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440125|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440126|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440127|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440128|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440129|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440130|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440131|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440132|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440133|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440134|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440135|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440136|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440137|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440138|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440139|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440140|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440141|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440142|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440143|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440144|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440145|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440146|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440147|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440148|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440149|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440150|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440151|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440152|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440429|NCT00517933|B1|Baseline|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
440153|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440154|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440155|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440156|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440157|NCT00518284|O4|Outcome|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440158|NCT00518284|O3|Outcome|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440159|NCT00518284|O2|Outcome|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440160|NCT00518284|O1|Outcome|Control|Following revascularization, participants did not receive any study drug treatment.
440161|NCT00518284|E4|Reported Event|During Flow Arrest + IV|Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440162|NCT00518284|E3|Reported Event|During Flow Arrest|Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
440163|NCT00518284|E2|Reported Event|Proximal to Lesion + IV|Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m^2 at 7 days.
440164|NCT00518284|E1|Reported Event|Control|Following revascularization, participants did not receive any study drug treatment.
440165|NCT00518180|B4|Baseline|Total|Total of all reporting groups
440166|NCT00518180|B3|Baseline|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440167|NCT00518180|B2|Baseline|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440168|NCT00518180|B1|Baseline|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440169|NCT00518180|P3|Participant Flow|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440170|NCT00518180|P2|Participant Flow|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440171|NCT00518180|P1|Participant Flow|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440172|NCT00518180|O3|Outcome|Tdap → MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2, 4, and 8
440173|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV at months 2, 4, and 8
440174|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
440175|NCT00518180|O3|Outcome|Tdap → MenACWY →HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440176|NCT00518180|O2|Outcome|MenACWY→Tdap → HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440177|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440178|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440179|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440180|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440181|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440182|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
440183|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440184|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440430|NCT00517933|P2|Participant Flow|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440185|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
440186|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440187|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440188|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
440189|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440190|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440191|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
440192|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440193|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440194|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440195|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440196|NCT00518180|O2|Outcome|HPV Alone|The three injections of the HPV vaccine was administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
440197|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440198|NCT00518180|O2|Outcome|HPV Alone|Three injections of the HPV vaccine were administered at study months 2, 4, and 8. This arm is a recombination of the two arms listed in the Participant Flow.
440199|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440200|NCT00518180|O3|Outcome|Tdap → MenACWY→HPV|Tdap was administered at study month 0 followed by one injection of the MenACWY vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440201|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8
440202|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440203|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440204|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440205|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440206|NCT00518180|O3|Outcome|Tdap →MenACWY → HPV|Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440207|NCT00518180|O2|Outcome|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
440208|NCT00518180|O1|Outcome|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
440209|NCT00518180|E3|Reported Event|Tdap → MenACWY → HPV|Tdpa was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of HPV at months 2,4 and 8.
440210|NCT00518180|E2|Reported Event|MenACWY→Tdap→HPV|The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdpa vaccine at month 1, followed by three injections of the HPV at months 2,4 and 8.
440211|NCT00518180|E1|Reported Event|MenACWY+Tdap+HPV|The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two vaccinations of the HPV vaccine at month 2 and 6.
440212|NCT00518115|B11|Baseline|Total|Total of all reporting groups
440213|NCT00518115|B10|Baseline|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440214|NCT00518115|B9|Baseline|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440215|NCT00518115|B8|Baseline|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440431|NCT00517933|P1|Participant Flow|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440216|NCT00518115|B7|Baseline|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440217|NCT00518115|B6|Baseline|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440218|NCT00518115|B5|Baseline|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440219|NCT00518115|B4|Baseline|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440220|NCT00518115|B3|Baseline|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440221|NCT00518115|B2|Baseline|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440222|NCT00518115|B1|Baseline|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440223|NCT00518115|P10|Participant Flow|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440224|NCT00518115|P9|Participant Flow|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440225|NCT00518115|P8|Participant Flow|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440226|NCT00518115|P7|Participant Flow|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440227|NCT00518115|P6|Participant Flow|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440228|NCT00518115|P5|Participant Flow|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440229|NCT00518115|P4|Participant Flow|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440230|NCT00518115|P3|Participant Flow|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440231|NCT00518115|P2|Participant Flow|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440232|NCT00518115|P1|Participant Flow|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440233|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
440234|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
440235|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
440259|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440522|NCT00517751|P1|Participant Flow|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440236|NCT00518115|O1|Outcome|All Participants Receiving Any Dose of Albiglutide|Participants received one of the following doses of albiglutide: 4 mg weekly, 15 mg weekly, 30 mg weekly (administered as a subcutaneous injection for 16 weeks) ; 15 mg bi-weekly, 30 mg bi-weekly, 50 mg bi-weekly (alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks); 50 mg every 4 weeks, 100 mg every 4 weeks (administered as a subcutaneous injection for 16 weeks). Participants received subcutaneous injections alternating between the left and right sides of the body.
440237|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440238|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440239|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440240|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440241|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440242|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440243|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440244|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440245|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440246|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440247|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440248|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440249|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440250|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440251|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440252|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440253|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440254|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440255|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440256|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440257|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440258|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440424|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440260|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440261|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440262|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440263|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440264|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440265|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440266|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440267|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440268|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440269|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440270|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440271|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440272|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440273|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440274|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440275|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440276|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440277|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440278|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440279|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440280|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440281|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440282|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440283|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440432|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440284|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440285|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440286|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440287|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440288|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440289|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440290|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440291|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440292|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440293|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440294|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440295|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440296|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440297|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440298|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440299|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440300|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440301|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440302|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440303|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440304|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440305|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440306|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440307|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440477|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440308|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440309|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440310|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440311|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440312|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440313|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440314|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440315|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440316|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440317|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440318|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440319|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440320|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440321|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440322|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440323|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440324|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440325|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440326|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440327|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440328|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440329|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440330|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440331|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440478|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440332|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440333|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440334|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440335|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440336|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440337|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440338|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440339|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440340|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440341|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440342|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440343|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440344|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440345|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440346|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440347|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440348|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440349|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440350|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440351|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440352|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440353|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440354|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440355|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440479|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440356|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440357|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440358|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440359|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440360|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440361|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440362|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440363|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440364|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440365|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440366|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440367|NCT00518115|O10|Outcome|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440368|NCT00518115|O9|Outcome|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440369|NCT00518115|O8|Outcome|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440370|NCT00518115|O7|Outcome|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440371|NCT00518115|O6|Outcome|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440372|NCT00518115|O5|Outcome|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440373|NCT00518115|O4|Outcome|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440374|NCT00518115|O3|Outcome|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440375|NCT00518115|O2|Outcome|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440376|NCT00518115|O1|Outcome|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440377|NCT00518115|E10|Reported Event|Albiglutide 100 mg Every 4 Weeks|Participants received albiglutide 100 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440378|NCT00518115|E9|Reported Event|Albiglutide 50 mg Every 4 Weeks|Participants received albiglutide 50 mg every 4 weeks, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440379|NCT00518115|E8|Reported Event|Albiglutide 50 mg Bi-weekly|Participants received albiglutide 50 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440425|NCT00518011|E2|Reported Event|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440380|NCT00518115|E7|Reported Event|Albiglutide 30 mg Bi-weekly|Participants received albiglutide 30 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440381|NCT00518115|E6|Reported Event|Albiglutide 15 mg Bi-weekly|Participants received albiglutide 15 mg every other week, alternating with placebo for each intervening week, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440382|NCT00518115|E5|Reported Event|Albiglutide 30 mg Weekly|Participants received albiglutide 30 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440383|NCT00518115|E4|Reported Event|Albiglutide 15 mg Weekly|Participants received albiglutide 15 mg weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440384|NCT00518115|E3|Reported Event|Albiglutide 4 mg Weekly|Participants received albiglutide 4 milligrams (mg) weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440385|NCT00518115|E2|Reported Event|Exenatide BID|Participants self-administered exenatide as a subcutaneous injection using prefilled pens, in accordance with current prescribing information. A dose of 5 micrograms (μg) was administered twice daily (BID) for the first 4 weeks, followed by a 12-week administration of a 10 μg BID dose. Participants who could not tolerate a 10 μg dose were to continue the study on the 5 μg BID dose.
440386|NCT00518115|E1|Reported Event|Placebo|Participants received placebo weekly, administered as a subcutaneous injection for 16 weeks. Participants received subcutaneous injections alternating between the left and right sides of the body.
440387|NCT00518089|B3|Baseline|Total|Total of all reporting groups
440388|NCT00518089|B2|Baseline|Placebo Eye Drops|
440389|NCT00518089|B1|Baseline|Gatifloxacin 0.5% Eye Drops|
440390|NCT00518089|P2|Participant Flow|Placebo Eye Drops|
440391|NCT00518089|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|
440392|NCT00518089|O2|Outcome|Placebo Eye Drops|
440393|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
440394|NCT00518089|O2|Outcome|Placebo Eye Drops|
440395|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
440396|NCT00518089|O2|Outcome|Placebo Eye Drops|
440397|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
440398|NCT00518089|O2|Outcome|Placebo Eye Drops|
440399|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
440400|NCT00518089|O2|Outcome|Placebo Eye Drops|
440401|NCT00518089|O1|Outcome|Gatifloxacin 0.5% Eye Drops|
440402|NCT00518089|E2|Reported Event|Placebo Eye Drops|
440403|NCT00518089|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|
440404|NCT00518011|B3|Baseline|Total|Total of all reporting groups
440405|NCT00518011|B2|Baseline|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440406|NCT00518011|B1|Baseline|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440407|NCT00518011|P2|Participant Flow|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440408|NCT00518011|P1|Participant Flow|Gemcitabine|Participants received Gemcitabine 1000 milligram per meter square (mg/m^2)/day, intravenously (IV) on Days 1, 8, 15 and every 4 weeks for 6 cycles
440409|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440410|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440411|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440412|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440413|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440414|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440415|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440416|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440417|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440418|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles.
440419|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440420|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440421|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440422|NCT00518011|O1|Outcome|Gemcitabine|Participants received Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440423|NCT00518011|O2|Outcome|Erlotinib + Gemcitabine|Participants received Erlotinib 150 mg/day orally as a continuous schedule with Gemcitabine 1000 (mg/m^2)/day, IV on Days 1, 8, 15 and every 4 weeks for 6 cycles
440520|NCT00517829|E1|Reported Event|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440433|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440434|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440435|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440436|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440437|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440438|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440439|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440440|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440441|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440442|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440443|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440444|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440445|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440446|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440447|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440448|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440449|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440450|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440451|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440452|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440453|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440454|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440455|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440456|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440457|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440458|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440459|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440460|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440461|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440462|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440463|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440464|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440465|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440466|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440467|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440468|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440469|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440470|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440471|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440472|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440473|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440474|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440475|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440476|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440480|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440481|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440482|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440483|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
440484|NCT00517933|O2|Outcome|Placebo / Sildenafil|20 mg oral placebo 3 times per day
440485|NCT00517933|O1|Outcome|Sildenafil / Sildenafil|20 mg oral sildenafil 3 times per day
440486|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440487|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440488|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440489|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440490|NCT00517933|O2|Outcome|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440491|NCT00517933|O1|Outcome|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for an additional 12 weeks.
440492|NCT00517933|E2|Reported Event|Placebo|20 mg of placebo 3 times per day for 12 weeks, followed by 20 mg open-label sildenafil 3 times per day for 12 weeks
440493|NCT00517933|E1|Reported Event|Sildenafil|20 mg of oral sildenafil 3 times per day for 12 weeks, followed by 20 mg oral sildenafil 3 times per day for 12 weeks
440494|NCT00517881|B1|Baseline|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440495|NCT00517881|P1|Participant Flow|C.E.R.A.|Participants received subcutaneous methoxy polyethylene glycol-epoetin beta (C.E.R.A.) at starting dose of 120, 200, or 360 micrograms (mcg) every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440496|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440497|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440498|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440499|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440500|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440501|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440502|NCT00517881|O1|Outcome|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440503|NCT00517881|E1|Reported Event|C.E.R.A.|Participants received subcutaneous C.E.R.A. at starting dose of 120, 200, or 360 mcg every 4 weeks for 20 weeks. Further dose adjustments were performed during the study depending on the participant’s blood hemoglobin levels.
440504|NCT00517829|B3|Baseline|Total|Total of all reporting groups
440505|NCT00517829|B2|Baseline|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440506|NCT00517829|B1|Baseline|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440507|NCT00517829|P2|Participant Flow|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440508|NCT00517829|P1|Participant Flow|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440509|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440510|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440511|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440512|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440513|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440514|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440515|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440516|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440517|NCT00517829|O2|Outcome|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440518|NCT00517829|O1|Outcome|DOCOX|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 every 21 days
440519|NCT00517829|E2|Reported Event|DOCOX+Cebuximab|Docetaxel 60 mg/m2 + Oxaliplatin 130 mg/m2 + Cetuximab 400 mg/m2 (first dose only, subsequent doses 250 mg/m2) every 21 days
440523|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440524|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440525|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440526|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440527|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440528|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440529|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440530|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440531|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440532|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440533|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440534|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440535|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440536|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440537|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440538|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440539|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440540|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440541|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440542|NCT00517751|O1|Outcome|X-STOP PEEK|In this arm, patients underwent X-STOP PEEK surgery.
440543|NCT00517751|E1|Reported Event|X-STOP PEEK|In this arm, patients will undergo X-STOP PEEK surgery.
440544|NCT00517699|B1|Baseline|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440545|NCT00517699|P1|Participant Flow|Rituximab, Cytarabine, and Methotrexate (MTX)|Participants received single doses of rituximab 750 milligrams per square meter (mg/m^2) intravenously (IV) at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 grams per square meter (g/m^2) IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440546|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440547|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440548|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440549|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440550|NCT00517699|O1|Outcome|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440551|NCT00517699|E1|Reported Event|Rituximab, Cytarabine, and MTX|Participants received single doses of rituximab 750 mg/m^2 IV at Weeks 1 through 5, and 7, 9, 11, 14, 16, 18, 20, and 22; cytarabine 2 g/m^2 IV every 24 hours for 2 doses at Weeks 11 and 22; and single doses of MTX 8 g/m^2 IV at Weeks 3, 5, 7, 9, 14, 16, 18, and 20.
440552|NCT00517634|B1|Baseline|Overall Study Population|Overall Study Population: participants in all three treatment periods
440553|NCT00517634|P6|Participant Flow|Sequence 6: Placebo, FP, SFC|Placebo in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
440554|NCT00517634|P5|Participant Flow|Sequence 5: FP, Placebo, SFC|Fluticasone Propionate 100 mcg BID in the first treatment period: Placebo in the second treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the third treatment period
440555|NCT00517634|P4|Participant Flow|Sequence 4: SFC, Placebo, FP|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the first treatment period: Placebo in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
440556|NCT00517634|P3|Participant Flow|Sequence 3: SFC, FP, Placebo|Salmeterol/Fluticasone Propionate 50/100 Combination mcg BID in the first treatment period: Fluticasone Propionate 100 mcg BID in the second treatment period: Placebo in the third treatment period
440557|NCT00517634|P2|Participant Flow|Sequence 2: Placebo, SFC, FP|Placebo in the first treatment period: Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID in the second treatment period: Fluticasone Propionate 100 mcg BID in the third treatment period
440558|NCT00517634|P1|Participant Flow|Sequence 1: FP, SFC, Placebo|Fluticasone Propionate (FP) 100 micrograms (mcg) twice daily (BID) in the first treatment period: Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID in the second treatment period: Placebo in the third treatment period
440559|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
440560|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
440561|NCT00517634|O1|Outcome|Placebo|Placebo
440562|NCT00517634|O3|Outcome|SFC 50/100 mcg BID|Salmeterol/Fluticasone Propionate Combination (SFC) 50/100 mcg BID
440563|NCT00517634|O2|Outcome|FP 100 mcg BID|Fluticasone Propionate (FP) 100 mcg BID
440564|NCT00517634|O1|Outcome|Placebo|Placebo
440565|NCT00517634|E3|Reported Event|SFC 50/100 BID|Salmeterol/Fluticasone Propionate Combination 50/100 mcg BID
440566|NCT00517634|E2|Reported Event|FP 100 mcg BID|Fluticasone Propionate 100 mcg BID
440567|NCT00517634|E1|Reported Event|Placebo|Placebo
440568|NCT00516386|B1|Baseline|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
440569|NCT00516386|P1|Participant Flow|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
440570|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
440571|NCT00516386|O1|Outcome|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
440572|NCT00516386|E1|Reported Event|RhIGF-1|All study subjects were administered rhIGF-1 at a dose of 35-40 mcg/k/dose twice daily SC for 7-10 days.
440573|NCT00517595|B1|Baseline|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440574|NCT00517595|P1|Participant Flow|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440575|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440576|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440577|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440578|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440579|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440580|NCT00517595|O1|Outcome|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440581|NCT00517595|E1|Reported Event|Pemetrexed, Gemcitabine, and Bevacizumab|All subjects received treatment with pemetrexed 500 mg/m^2, gemcitabine 1500 mg/m^2, and bevacizumab 10 mg/kg every 2 weeks.
440582|NCT00517530|B8|Baseline|Total|Total of all reporting groups
440583|NCT00517530|B7|Baseline|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440584|NCT00517530|B6|Baseline|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440585|NCT00517530|B5|Baseline|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440586|NCT00517530|B4|Baseline|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440587|NCT00517530|B3|Baseline|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440588|NCT00517530|B2|Baseline|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
440589|NCT00517530|B1|Baseline|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
440590|NCT00517530|P7|Participant Flow|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440591|NCT00517530|P6|Participant Flow|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440592|NCT00517530|P5|Participant Flow|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440593|NCT00517530|P4|Participant Flow|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440594|NCT00517530|P3|Participant Flow|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440595|NCT00517530|P2|Participant Flow|400-2000 mg Phase I, CLL|Obinutuzumab intravenous infusion
440596|NCT00517530|P1|Participant Flow|50-2000 mg Phase I, NHL|Obinutuzumab intravenous infusion
440597|NCT00517530|O4|Outcome|2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440598|NCT00517530|O3|Outcome|1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440599|NCT00517530|O2|Outcome|800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440600|NCT00517530|O1|Outcome|400 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440601|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440602|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440603|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440604|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440605|NCT00517530|O4|Outcome|2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440606|NCT00517530|O3|Outcome|1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440607|NCT00517530|O2|Outcome|800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440608|NCT00517530|O1|Outcome|400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440609|NCT00517530|O1|Outcome|Retreated Participants|Obinutuzumab intravenous infusion
440610|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440611|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440612|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440613|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440614|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440615|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440616|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440617|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440618|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440619|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
445474|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
440620|NCT00517530|O3|Outcome|Phase II, CLL|Obinutuzumab intravenous infusion at 1000/1000 mg
440621|NCT00517530|O2|Outcome|Phase II, aNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
440622|NCT00517530|O1|Outcome|Phase II, iNHL|Obinutuzumab intravenous infusion at 400/400 mg and 1600/800 mg
440623|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440624|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440625|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440626|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440627|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440628|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440629|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440630|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440631|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440632|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440633|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440634|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440635|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440636|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440637|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440638|NCT00517530|O5|Outcome|1000/1000 mg - Phase II, CLL|Obinutuzumab intravenous infusion
440639|NCT00517530|O4|Outcome|1600/800 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440640|NCT00517530|O3|Outcome|400/400 mg - Phase II, aNHL|Obinutuzumab intravenous infusion
440641|NCT00517530|O2|Outcome|1600/800 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440642|NCT00517530|O1|Outcome|400/400 mg - Phase II, iNHL|Obinutuzumab intravenous infusion
440643|NCT00517530|O11|Outcome|1000/1000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440644|NCT00517530|O10|Outcome|1200/2000 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440645|NCT00517530|O9|Outcome|800/1200 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440646|NCT00517530|O8|Outcome|400/800 mg - Phase I, CLL|Obinutuzumab intravenous infusion
440647|NCT00517530|O7|Outcome|1600/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440648|NCT00517530|O6|Outcome|1200/2000 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440649|NCT00517530|O5|Outcome|800/1200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440650|NCT00517530|O4|Outcome|400/800 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440651|NCT00517530|O3|Outcome|200/400 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440652|NCT00517530|O2|Outcome|100/200 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440653|NCT00517530|O1|Outcome|50/100 mg - Phase I, NHL|Obinutuzumab intravenous infusion
440654|NCT00517530|E1|Reported Event|Safety Population|Safety-Evaluable Participants
440655|NCT00517413|B1|Baseline|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440656|NCT00517413|P1|Participant Flow|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and previously treated with intravenous (IV) or subcutaneous (SC) epoetin alfa, epoetin beta or darbepoetin alfa received monthly treatment with Continuous Erythropoietin Receptor Activator (C.E.R.A.) (methoxy polyethylene glycol-epoetin beta [Mircera]). The initial dose of C.E.R.A. was based on the last dose of the previous Erythropoiesis Stimulating Agent (ESA); 120, 200, or 360 micrograms (mcg) C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440657|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440658|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440659|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440660|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440661|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440662|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440689|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
441848|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
440663|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440664|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440665|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440666|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440667|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440668|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440669|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440670|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440671|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440672|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440673|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440674|NCT00517413|O1|Outcome|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440675|NCT00517413|E1|Reported Event|C.E.R.A|Participants with chronic renal anaemia who were on dialysis and were previously treated with IV or SC epoetin alfa, epoetin beta or darbepoetin alfa, received monthly treatment with C.E.R.A. The initial dose of C.E.R.A. was based on the last dose of the previous ESA; 120, 200, or 360 mcg C.E.R.A., IV or SC, every 4 weeks for 48 weeks.
440676|NCT00517361|B1|Baseline|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440677|NCT00517361|P1|Participant Flow|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440678|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440679|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440680|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440681|NCT00517361|O1|Outcome|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440682|NCT00517361|E1|Reported Event|Carboplatin + Avastin|Carboplatin in 250mL saline IV over 30 minutes and Avastin (Bevacizumab) 15mg/kg in 100mL saline IV over 60 - 90 minutes
440683|NCT00517192|B3|Baseline|Total|Total of all reporting groups
440684|NCT00517192|B2|Baseline|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440685|NCT00517192|B1|Baseline|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440686|NCT00517192|P2|Participant Flow|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440687|NCT00517192|P1|Participant Flow|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440688|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440690|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440691|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440692|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440693|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440694|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440695|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440696|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440697|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440698|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440699|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440700|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440701|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440702|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440703|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440704|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440705|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440706|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440707|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440708|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440709|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440710|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440711|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440712|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440713|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440714|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440715|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440716|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440717|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440718|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440719|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440720|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440721|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440722|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
445475|NCT00502775|O1|Outcome|Placebo|
440723|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440724|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440725|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440726|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440727|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440728|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440729|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440730|NCT00517192|O2|Outcome|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440731|NCT00517192|O1|Outcome|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440732|NCT00517192|E2|Reported Event|Darunavir 600 mg/Ritonavir 100 mg|Prezista® (DRV) 300 mg tablets Ritonavir (RTV) 100 mg soft gelatin capsules dose: 600 mg DRV/100 mg RTV, twice daily mode of admin.: Oral
440733|NCT00517192|E1|Reported Event|Tipranavir 500 mg/Ritonavir 200 mg|Tipranavir (TPV) 250 mg soft gelatin capsules Ritonavir (RTV) 100 mg soft gelatin capsules dose: 500 mg TPV/200 mg RTV, twice daily mode of admin.: Oral
440734|NCT00517075|B5|Baseline|Total|Total of all reporting groups
440735|NCT00517075|B4|Baseline|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440736|NCT00517075|B3|Baseline|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440737|NCT00517075|B2|Baseline|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440738|NCT00517075|B1|Baseline|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440739|NCT00517075|P4|Participant Flow|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440740|NCT00517075|P3|Participant Flow|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
445476|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
440741|NCT00517075|P2|Participant Flow|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440742|NCT00517075|P1|Participant Flow|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440743|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440744|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440745|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440746|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440747|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440748|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440749|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440812|NCT00516737|B2|Baseline|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440813|NCT00516737|B1|Baseline|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440814|NCT00516737|P2|Participant Flow|Placebo|Matching placebo; one dose, treatment of a single migraine attack
441849|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
440750|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440751|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440752|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440753|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440754|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440755|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440756|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440757|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440758|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440815|NCT00516737|P1|Participant Flow|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440816|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440817|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440759|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440760|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440761|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440762|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440763|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440764|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440765|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440766|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440767|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440818|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440819|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440768|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440769|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440770|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440771|NCT00517075|O4|Outcome|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440772|NCT00517075|O3|Outcome|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440773|NCT00517075|O2|Outcome|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440774|NCT00517075|O1|Outcome|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440775|NCT00517075|E4|Reported Event|Open Cross Over High Frequency rTMS|"Following the randomization phase with three arms, subjects who did not respond, have the possibility of receiving open active treatment to the target that they did not receive treatment to in the randomization phase. (i.e. randomized to IPL --> open phase DLPFC and vice versa)~repetitive transcranial magnetic stimulation: For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440776|NCT00517075|E3|Reported Event|Sham/Placebo|"Sham (placebo) high frequency rTMS to the left dorsolateral prefrontal cortex or left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440820|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440821|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440822|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440777|NCT00517075|E2|Reported Event|Active High Frequency rTMS|"Active high frequency rTMS to the left dorsolateral prefrontal cortex~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440778|NCT00517075|E1|Reported Event|High Frequency rTMS|"high frequency rTMS to the left infero-parietal lobe, active/sham condition randomized (2:1), double-blind~Transcranial Magnetic Stimulation (TMS): For rTMS, the coil is held flat on the scalp. 40 trains of 10 Hz rTMS will be delivered in trains lasting 4 seconds, with an intertrain interval of 26 seconds, for a total of 20 minutes (1600 pulses per day) at 100% motor threshold. Subjects will receive rTMS once a day, 5 days a week, for 4 weeks. During the first week of rTMS sessions only, in the event that the patient cannot tolerate these stimulation parameters, intensity relative to motor threshold may be titrated downward, in a masked fashion, to 80%, with all other dose parameters remaining the same."
440779|NCT00517010|B1|Baseline|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
440780|NCT00517010|P1|Participant Flow|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
440781|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
440782|NCT00517010|O1|Outcome|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
440783|NCT00517010|E1|Reported Event|Lucentis Combined With Proton Beam|Proton beam irradiation and ranibizumab: ranibizumab 0.5mg intravitreal monthly x 4, then prn combined with low dose proton beam irradiation 24Gy (2 fractions, 24 hours apart) during the first month of study.
440784|NCT00516919|B1|Baseline|Total Enrollment|
440785|NCT00516919|P2|Participant Flow|Placebo + Behavioral Intervention|"Drug: Placebo + Behavioral: behavioral intervention~Behavioral intervention + placebo : Behavioral weight loss treatment in Spanish Placebo three times a day"
440786|NCT00516919|P1|Participant Flow|Xenical + Behavioral Intervention|"Drug: Xenical + Behavioral: behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
440787|NCT00516919|O2|Outcome|Drug: Placebo + Behavioral: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
440788|NCT00516919|O1|Outcome|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
440789|NCT00516919|E2|Reported Event|Drug: Placebo + Behaviora: Behavioral Intervention|"Placebo + behavioral intervention~Behavioral intervention + placebo three times a day: Behavioral weight loss treatment in Spanish Placebo TID"
440790|NCT00516919|E1|Reported Event|Drug: Xenical + Behavioral: Behavioral Intervention|"Xenical + behavioral intervention~Xenical + behavioral intervention : 120 mg three times a day; Behavioral weight loss in Spanish"
440791|NCT00516906|B3|Baseline|Total|Total of all reporting groups
440792|NCT00516906|B2|Baseline|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440793|NCT00516906|B1|Baseline|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440794|NCT00516906|P2|Participant Flow|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440795|NCT00516906|P1|Participant Flow|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440796|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440797|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440798|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440799|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440800|NCT00516906|O2|Outcome|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440801|NCT00516906|O1|Outcome|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440802|NCT00516906|E2|Reported Event|CHG Antimicrobial Transparent Dressing|Chlorhexidine gluconate antimicrobial transparent adhesive dressing
440803|NCT00516906|E1|Reported Event|Placebo Comparator: A|Standard of Care Transparent Adhesive Dressing
440804|NCT00516893|B1|Baseline|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440805|NCT00516893|P1|Participant Flow|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440806|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440807|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440808|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440809|NCT00516893|O1|Outcome|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440810|NCT00516893|E1|Reported Event|Natalizumab High Titer|natalizumab high titer 300 mg administered as intravenous (IV) infusion over 60 minutes once every 4 weeks for up to 9 doses
440811|NCT00516737|B3|Baseline|Total|Total of all reporting groups
440823|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440824|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440825|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440826|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440827|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440828|NCT00516737|O2|Outcome|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440829|NCT00516737|O1|Outcome|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440830|NCT00516737|E2|Reported Event|Placebo|Matching placebo; one dose, treatment of a single migraine attack
440831|NCT00516737|E1|Reported Event|Rizatriptan 10 mg ODT|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT); one dose, treatment of a single migraine attack
440832|NCT00516321|B3|Baseline|Total|Total of all reporting groups
440833|NCT00516321|B2|Baseline|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440834|NCT00516321|B1|Baseline|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440835|NCT00516321|P3|Participant Flow|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440836|NCT00516321|P2|Participant Flow|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440837|NCT00516321|P1|Participant Flow|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
440838|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440839|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440840|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440841|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440842|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440843|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440844|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440845|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440846|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
441504|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
440847|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440848|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440849|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440850|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440851|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440852|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440853|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440854|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440855|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440856|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440857|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440858|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440859|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440860|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440861|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440862|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440863|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440864|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440865|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440866|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440867|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440868|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440869|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440870|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440871|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440872|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440873|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440874|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440875|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440876|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
440877|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
440878|NCT00516321|O1|Outcome|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
440879|NCT00516321|O2|Outcome|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440880|NCT00516321|O1|Outcome|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440881|NCT00516321|E3|Reported Event|Eltrombopag+Antiviral Therapy: DB Phase|Participants completing the OL Phase continued on the same dose of eltrombopag received in the OL Phase (dose that effectively raised platelets to >=90 Gi/L) in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440882|NCT00516321|E2|Reported Event|Placebo+Antiviral Therapy: DB Phase|Participants completing the OL Phase were administered matching placebo tablets QD in combination with antiviral therapy (peginterferon alfa-2a and ribavirin) for a duration of either 24 or 48 weeks (for participants with Genotype 2/3) or 48 weeks (for participants with Non-Genotype 2/3).
440883|NCT00516321|E1|Reported Event|Eltrombopag: OL Phase|Participants with a platelet count of <75 giga (10^9) cells per liter (Gi/L) initially received eltrombopag 25 milligrams (mg) once daily (QD) for 2 weeks. After 2 weeks, if the platelet count was <90 Gi/L, participants underwent dose escalation to 50 mg QD for 2 weeks. If platelet counts still remained <90 Gi/L, further dose escalations to 75 mg QD (up to 2 weeks) and 100 mg QD (up to a maximum of 3 weeks) were allowed. Participants who achieved platelet counts >=90 Gi/L during the OL Phase (maximum of up to 9 weeks) were eligible to enter the Double-blind (DB) Antiviral Treatment Phase, whereas those who failed to reach platelet counts >=90 Gi/L were discontinued from eltrombopag and had to attend the post-treatment follow-up visits.
440884|NCT00516295|B4|Baseline|Total|Total of all reporting groups
440885|NCT00516295|B3|Baseline|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
440886|NCT00516295|B2|Baseline|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I
440887|NCT00516295|B1|Baseline|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
440888|NCT00516295|P3|Participant Flow|Arm III (CTC)|Patients receive vincristine, topotecan hydrochloride, and cyclophosphamide as in arm I.
440889|NCT00516295|P2|Participant Flow|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
440890|NCT00516295|P1|Participant Flow|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
440891|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
440892|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
440893|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
440894|NCT00516295|O3|Outcome|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
440895|NCT00516295|O2|Outcome|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
440896|NCT00516295|O1|Outcome|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
440897|NCT00516295|E3|Reported Event|Arm III (VTC)|Patients receive vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in arm I.
440898|NCT00516295|E2|Reported Event|Arm II (VTCB)|Patients receive bevacizumab, vincristine sulfate, topotecan hydrochloride, and cyclophosphamide as in Arm I.
440899|NCT00516295|E1|Reported Event|Arm I (Feasibility Assessment of VTCB)|"Patients receive bevacizumab IV over 30-90 minutes on day 1, vincristine sulfate IV on days 1, 8, and 15, and topotecan hydrochloride IV over 30 minutes and cyclophosphamide IV over 60 minutes on days 1-5. Treatment repeats every 21 days (except during weeks 14, 15 [course 5], 17, 18 [course 6], 26, 27 [course 9], 29, and 30 [course 10] when no chemotherapy is given) for up to 12 courses in the absence of disease progression or unacceptable toxicity.~topotecan hydrochloride: Given IV~vincristine sulfate: Given IV~cyclophosphamide: Given IV~bevacizumab: Given IV"
440900|NCT00516269|B3|Baseline|Total|Total of all reporting groups
440901|NCT00516269|B2|Baseline|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
440902|NCT00516269|B1|Baseline|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
440903|NCT00516269|P2|Participant Flow|Placebo Then Methylphenidate|Placebo oral daily for 2 weeks then Methylphenidate 18 mg oral daily for 2 weeks
440904|NCT00516269|P1|Participant Flow|Methylphenidate Then Placebo|Methylphenidate 18 mg oral daily for 2 weeks then Placebo oral daily for 2 weeks
440905|NCT00516269|O2|Outcome|Placebo|Placebo taken oral daily for 2 Weeks.
440906|NCT00516269|O1|Outcome|Methylphenidate|Methylphenidate 18 mg oral daily for 2 Weeks preceded or followed by Placebo oral daily for 2 weeks.
440907|NCT00516269|E2|Reported Event|Placebo Then Methylphenidate|"Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
440908|NCT00516269|E1|Reported Event|Methylphenidate Then Placebo|"18 mg Oral Daily for 2 Weeks~Placebo : Capsule By Mouth Daily x 2 Weeks~Methylphenidate : 18 mg By Mouth Daily x 2 Weeks"
441505|NCT00515112|E2|Reported Event|Placebo|"Three subjects received the placebo~Placebo: placebo"
440909|NCT00516217|B1|Baseline|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440910|NCT00516217|P1|Participant Flow|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440911|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440912|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440913|NCT00516217|O1|Outcome|Galaximab|Induction: 500 mg/m^2 by IV over 60 minutes days 1, 8, 15 & 22 Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440914|NCT00516217|E1|Reported Event|Galaximab|Extended Induction: 500 mg/m^2 by IV every 4 weeks until disease progression or unacceptable toxicity
440915|NCT00516165|B1|Baseline|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440916|NCT00516165|P1|Participant Flow|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440917|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440918|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440919|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440920|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440921|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440922|NCT00516165|O1|Outcome|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440923|NCT00516165|E1|Reported Event|RAD001|"Patients will receive RAD001 10 mg/day orally (6 weeks/cycle). Patients will be continued on treatment until disease progression, limiting toxicity, patient withdrawal of consent, or death.~RAD001: Oral pills taken daily in a 42-day cycle (6 weeks). Cycles will be repeated every 42 days"
440924|NCT00516139|B1|Baseline|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440925|NCT00516139|P1|Participant Flow|Lamotrigine (LTG)-Extended Release (XR) Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440926|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440968|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
441850|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
440927|NCT00516139|O1|Outcome|LTG-XR + Neutral, EIAEDs, and VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA and EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440928|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440929|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440930|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440931|NCT00516139|O3|Outcome|LTG-XR + VPA|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included VPA), followed by an 8-w Adjunctive Maintenance Phase: LTG-XR tablets administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440932|NCT00516139|O2|Outcome|LTG-XR + EIAEDs|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-w Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (included EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440933|NCT00516139|O1|Outcome|LTG-XR + Neutral|LTG-XR tablets (25, 50, 100, and 200 mg) were administered OD in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant AED (does not include VPA or EIAEDs), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440969|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440970|NCT00516074|E2|Reported Event|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440971|NCT00516074|E1|Reported Event|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440972|NCT00516048|B3|Baseline|Total|Total of all reporting groups
441851|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
440934|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440935|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440936|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440937|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440938|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440939|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440940|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440973|NCT00516048|B2|Baseline|Positive Baseline (Week 0) Antibody Status|Patients assessed as positive for antibodies to exenatide at baseline (Week 0).
440974|NCT00516048|B1|Baseline|Negative Baseline (Week 0) Antibody Status|Patients assessed as negative for antibodies to exenatide at baseline (Week 0).
440975|NCT00516048|P3|Participant Flow|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
440941|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440942|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440943|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440944|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440945|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440946|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440947|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440976|NCT00516048|P2|Participant Flow|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
440977|NCT00516048|P1|Participant Flow|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
445477|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
440948|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440949|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440950|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440951|NCT00516139|O1|Outcome|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440952|NCT00516139|E1|Reported Event|LTG-XR Tablets|LTG-XR tablets (25, 50, 100, and 200 milligrams [mg]) administered once a day (OD) in the 7-week (w) Dose-Escalation Phase and titrated to target doses of 300, 500, or 200 mg/day for participants (par.) depending on their concomitant antiepileptic drug (AED), followed by an 8-w Adjunctive Maintenance Phase in which LTG-XR tablets were administered OD at the target dose. Par. on a single concomitant AED who converted to LTG-XR monotherapy (based on investigator's judgment) entered the 5-w Conversion Phase, followed by an 8-w Monotherapy Phase, whereas par. who did not transition to monotherapy entered the 13-w Adjunctive Optimization Phase. At the end of the study, par. entered the 2- to 5-w Taper/Follow-Up Phase, in which par. either switched to commercial LTG (received same total daily dose of commercial LTG in 2 divided doses [BID]) or did not switch to commercial LTG (current dose was reduced by approximately one-fourth per week) with a final visit 2 weeks after last LTG-XR dose.
440953|NCT00516074|B3|Baseline|Total|Total of all reporting groups
440954|NCT00516074|B2|Baseline|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440955|NCT00516074|B1|Baseline|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440956|NCT00516074|P2|Participant Flow|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440957|NCT00516074|P1|Participant Flow|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440958|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440959|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440960|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440961|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440962|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440963|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440964|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440965|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
440966|NCT00516074|O2|Outcome|Placebo|Placebo injection twice daily (volume equivalent to the exenatide injection in the experimental arm).
440967|NCT00516074|O1|Outcome|Exenatide BID|5mcg exenatide twice daily for 4 weeks, and then 10mcg exenatide twice daily for the remaining 8 weeks of the study.
441083|NCT00515541|E2|Reported Event|Group B|Lovaza plus aspirin
440978|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
440979|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
440980|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
440981|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
440982|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
440983|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
440984|NCT00516048|O3|Outcome|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
440985|NCT00516048|O2|Outcome|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
440986|NCT00516048|O1|Outcome|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
440987|NCT00516048|E3|Reported Event|Enrolled But Withdrew Before Receiving Treatment|No exenatide treatment administered and no post-baseline (post-Week 0) assessment of antibody status was conducted.
440988|NCT00516048|E2|Reported Event|Exenatide: Treatment-Emergent Antibody Positive|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as positive for antibodies to exenatide at any point in the study.
440989|NCT00516048|E1|Reported Event|Exenatide:Treatment-Emergent Antibody Negative|5mcg exenatide for 4 weeks, followed by 10mcg exenatide for 20 weeks. Assessed as negative for antibodies to exenatide throughout the study.
440990|NCT00515879|B3|Baseline|Total|Total of all reporting groups
440991|NCT00515879|B2|Baseline|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
440992|NCT00515879|B1|Baseline|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
440993|NCT00515879|P2|Participant Flow|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
440994|NCT00515879|P1|Participant Flow|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
440995|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
440996|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
440997|NCT00515879|O2|Outcome|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
440998|NCT00515879|O1|Outcome|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
440999|NCT00515879|E2|Reported Event|Placebo-augmented CBT|Participants will receive placebo augmented cognitive behavioral therapy
441000|NCT00515879|E1|Reported Event|D-cycloserine-augmented CBT|Participants will receive D-cycloserine augmented cognitive behavioral therapy
441001|NCT00515827|B3|Baseline|Total|Total of all reporting groups
441002|NCT00515827|B2|Baseline|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
441003|NCT00515827|B1|Baseline|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
441004|NCT00515827|P2|Participant Flow|Placebo Then Raltegravir (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12; halt placebo at Week 12 and add 400 mg raltegravir tablet twice daily for 12 weeks.
441005|NCT00515827|P1|Participant Flow|Raltegravir Then Placebo (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12; halt raltegravir at Week 12 and add placebo twice daily for 12 weeks
441006|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441007|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441008|NCT00515827|O2|Outcome|Raltegravir (Arm B)|400 mg raltegravir (MK-0518) administered twice daily in addition to OBR from week 12 to week 24
441009|NCT00515827|O1|Outcome|Placebo (Arm A)|Placebo administered twice daily in addition to optimized background regimen (OBR) from week 12 to week 24
441010|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441011|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441012|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441013|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441014|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441015|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441016|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441017|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441018|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441019|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441020|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441021|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441022|NCT00515827|O2|Outcome|Placebo (Arm B)|Placebo administered twice daily in addition to OBR from entry until Week 12
441023|NCT00515827|O1|Outcome|Raltegravir (Arm A)|400 mg raltegravir (MK-0518) administered twice daily in addition to optimized background regimen (OBR) from entry to Week 12
441024|NCT00515827|E2|Reported Event|Placebo|Week 12 to Week 24 for Arm A (Raltegravir then Placebo), and Baseline to Week 12 for Arm B (Placebo then Raltegravir).
441025|NCT00515827|E1|Reported Event|Raltegravir|Baseline to Week 12 for Arm A (Raltegravir then Placebo), and Week 12 to Week 24 for Arm B (Placebo then Raltegravir).
441026|NCT00515697|B1|Baseline|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441027|NCT00515697|P1|Participant Flow|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441028|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441029|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441030|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441031|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441032|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441033|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441034|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441035|NCT00515697|O1|Outcome|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441036|NCT00515697|E1|Reported Event|Ramucirumab|Ramucirumab at 8 milligrams per kilogram (mg/kg) infused intravenously over 1 hour, on Day 1 of every 14-day cycle. Treatment continued until there was evidence of disease progression or intolerable toxicity.
441037|NCT00515671|B3|Baseline|Total|Total of all reporting groups
441038|NCT00515671|B2|Baseline|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441039|NCT00515671|B1|Baseline|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441040|NCT00515671|P2|Participant Flow|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441041|NCT00515671|P1|Participant Flow|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441042|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441043|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441044|NCT00515671|O2|Outcome|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441045|NCT00515671|O1|Outcome|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441046|NCT00515671|E2|Reported Event|Arm 2|"Receives support groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441047|NCT00515671|E1|Reported Event|Arm 1|"Receives IMR groups once a week for 9 months in addition to care as usual.~Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness"
441048|NCT00515619|B1|Baseline|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441084|NCT00515541|E1|Reported Event|Group A|Lovaza only
445478|NCT00502775|O1|Outcome|Placebo|
441049|NCT00515619|P1|Participant Flow|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441050|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441051|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441052|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441053|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441054|NCT00515619|O1|Outcome|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441055|NCT00515619|E1|Reported Event|Lacosamide|50 mg and 100 mg tablets of lacosamide up to 800 mg/day as twice day (BID) dosing throughout the trial (flexible dosing)
441056|NCT00515541|B5|Baseline|Total|Total of all reporting groups
441057|NCT00515541|B4|Baseline|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject is taking Warfarin and Aspirin (< or = 325mg)and is not taking Clopidogrel. Subject is taking escalating doses of Lovaza over a 24 week period.
441058|NCT00515541|B3|Baseline|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject is taking Clopidogrel 75mg)and Aspirin (< or = 325mg) and not taking Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
441059|NCT00515541|B2|Baseline|Group. B: Subject on Lovaza + Aspirin|Group B: Subject on Aspirin (< or = 325mg and is not taking Clopidogrel or Warfarin. Subject is taking escalating doses of Lovaza over a 24 week period.
441060|NCT00515541|B1|Baseline|Group A: Subject on Lovaza Only|Group A: Subject is not on Aspirin, Clopidogrel, or Warfarin. Subject is taking escalating doses of study drug (Lovaza)over a 24 week period.
441061|NCT00515541|P4|Participant Flow|Group D: Subjects on Lovaza Plus Warfarin and Aspirin|Subject is regularly taking Warfarin and Aspirin (< or = 325mg)daily, and not taking Clopidogrel. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Warfarin and Aspirin up to 24 weeks.
441062|NCT00515541|P3|Participant Flow|Group C: Subjects on Lovaza Plus Clopidogrel and Aspirin|Subject is regularly taking Clopidogrel (75mg)and Aspirin (< or = 325mg)daily, and not taking Warfarin. Subjects will be taking escalating doses of study drug (Lovaza)in addition to Clopidogrel and Aspirin up to 24 weeks.
441063|NCT00515541|P2|Participant Flow|Group B: Subjects on Lovaza Plus Aspirin|Group B: Subject is only taking Aspirin (< or = 325mg) daily. Subjects will be taking escalating doses of study drug (Lovaza) in addition to aspirin up to 24 weeks.
441064|NCT00515541|P1|Participant Flow|Group A: Subjects on Lovaza Only|Group A: Subject is healthly and not on Aspirin, Clopidogrel, or Warfarin. Subjects will be taking escalating doses of the study drug (Lovaza)up to 24 weeks.
441065|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
441066|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441067|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441068|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441069|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
441070|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441071|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441072|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441073|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
441074|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441075|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441076|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441077|NCT00515541|O4|Outcome|Group D: Subject on Lovaza + Warfarin + Aspirin|Group D: Subject on study drug (Lovaza) plus Warfarin and Aspirin (< or = 325mg, and not on Clopidogrel. Subject on escalating doses of Lovaza over a 24 week period.
441078|NCT00515541|O3|Outcome|Group C: Subject on Lovaza + Clopidogrel + Aspirin|Group C: Subject on study drug (Lovaza) plus Clopidogrel (75mg) and Aspirin (< or = 325mg, and not on Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441079|NCT00515541|O2|Outcome|Group B: Subject on Lovaza + Aspirin|Group B: Subject on study drug (Lovaza) plus Aspirin (< or = 35mg)and not on Clopidogrel or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441080|NCT00515541|O1|Outcome|Group A: Subject on Lovaza Only|Group A: Subject on study drug (Lovaza) and not on Aspirin, Clopidogrel, or Warfarin. Subject on escalating doses of Lovaza over a 24 week period.
441081|NCT00515541|E4|Reported Event|Group D|Lovaza plus aspirin plus coumadin
441082|NCT00515541|E3|Reported Event|Group C|Lovaza plus clopidogrel
441085|NCT00515502|B1|Baseline|All Study Treatments|Participants received a sequence containing 4 of the following 5 possible treatments: placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and Tiotropium 18 µg. Participants received each of the treatments in 1 of 4 single dose treatment periods, each of which was followed by a washout period. Treatment periods 1, 2, and 3 were followed by at least a 14-day washout period; Treatment period 4 was followed by a Follow-up visit within 10 days.
441086|NCT00515502|P12|Participant Flow|Seq 12: UMEC 250 µg, Placebo, UMEC 500 µg, Tiotropium 18 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.
441087|NCT00515502|P11|Participant Flow|Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
441088|NCT00515502|P10|Participant Flow|Seq 10: Tiotropium 18 µg, UMEC 250 µg, Placebo, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
441089|NCT00515502|P9|Participant Flow|Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
441090|NCT00515502|P8|Participant Flow|Seq 8: Tiotropium 18 µg, Placebo, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
441091|NCT00515502|P7|Participant Flow|Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
441092|NCT00515502|P6|Participant Flow|Seq 6: UMEC 250 µg, Placebo, Tiotropium 18 µg, UMEC 500 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.
441093|NCT00515502|P5|Participant Flow|Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
441094|NCT00515502|P4|Participant Flow|Seq 4: UMEC 250 µg, UMEC 500 µg, Placebo, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
441095|NCT00515502|P3|Participant Flow|Seq 3: UMEC 250 µg, Placebo, UMEC 500 µg, UMEC 1000 µg|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.
441096|NCT00515502|P2|Participant Flow|Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
441097|NCT00515502|P1|Participant Flow|Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, Placebo|Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.
441098|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441099|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441100|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441101|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441102|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441103|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441104|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441105|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441106|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441107|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441108|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441109|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441110|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441111|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441112|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441113|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441114|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441115|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441116|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441117|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441118|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441119|NCT00515502|O1|Outcome|UMEC 250 µg|
441120|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441121|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441122|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441123|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441124|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441125|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441126|NCT00515502|O3|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441127|NCT00515502|O2|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441128|NCT00515502|O1|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441129|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441130|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441131|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441132|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441133|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441134|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441135|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441136|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441137|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441138|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441139|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441140|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441141|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441142|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441143|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441144|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441145|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441146|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441147|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441148|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441149|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441150|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441151|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441152|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441153|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441154|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441155|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441156|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441157|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441158|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441159|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441160|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441161|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441162|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441163|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441164|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441165|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441166|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441167|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441168|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441169|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441170|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441171|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441172|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441478|NCT00515177|B2|Baseline|Randomized to PCT|
441173|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441174|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441175|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441176|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441177|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441178|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441179|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441180|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441181|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441182|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441183|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441184|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441185|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441186|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441187|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441188|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441189|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441190|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441191|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441192|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441193|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441194|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441195|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441196|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441197|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441198|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441199|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441200|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441201|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441202|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441203|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441479|NCT00515177|B1|Baseline|Randomized to MBSR|
441204|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441205|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441206|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441207|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441208|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441209|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441210|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441211|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441212|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441213|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441214|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441215|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441216|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441217|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441218|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441219|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441220|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441221|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441222|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441223|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441224|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441225|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441226|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441227|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441228|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441229|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441230|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441231|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441232|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441233|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441234|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
445479|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
441235|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441236|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441237|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441238|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441239|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441240|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441241|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441242|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441243|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441244|NCT00515502|O5|Outcome|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441245|NCT00515502|O4|Outcome|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441246|NCT00515502|O3|Outcome|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441247|NCT00515502|O2|Outcome|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 micrograms (µg) via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441248|NCT00515502|O1|Outcome|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441249|NCT00515502|E5|Reported Event|Tiotropium 18 µg|Participants received a single inhaled dose of a dry powder formulation of tiotropium 18 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441250|NCT00515502|E4|Reported Event|UMEC 1000 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 1000 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441251|NCT00515502|E3|Reported Event|UMEC 500 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 500 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441252|NCT00515502|E2|Reported Event|UMEC 250 µg|Participants received a single inhaled dose of a dry powder formulation of UMEC 250 µg via a DPI in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441253|NCT00515502|E1|Reported Event|Placebo|Participants received a single inhaled dose of matching placebo via a dry powder inhaler (DPI) in one of the 4 treatment periods, separated by a washout period of at least 14 days.
441254|NCT00515463|B3|Baseline|Total|Total of all reporting groups
441255|NCT00515463|B2|Baseline|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441256|NCT00515463|B1|Baseline|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441257|NCT00515463|P2|Participant Flow|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441258|NCT00515463|P1|Participant Flow|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441259|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441260|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441261|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441262|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441263|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441264|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441265|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441266|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441267|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441268|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441269|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441502|NCT00515112|O1|Outcome|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
441270|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441271|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441272|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441273|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441274|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441275|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441276|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441277|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441278|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441279|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441280|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441281|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441282|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441283|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441284|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441285|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441286|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441287|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441288|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441289|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441290|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441291|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441292|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441293|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441294|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441295|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441296|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441297|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441298|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441299|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441300|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441301|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441302|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441303|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441304|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441305|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441306|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441307|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441308|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441309|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441310|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441311|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
445480|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
441312|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441313|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441314|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441315|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441316|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441317|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441318|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441319|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441320|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441321|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441322|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441323|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441324|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441325|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441326|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441327|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441328|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441329|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441330|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441331|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441332|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441333|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441334|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441335|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441336|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441337|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441338|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441339|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441340|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441341|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441342|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441343|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441344|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441345|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441346|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441347|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441348|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441349|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441350|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441351|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441352|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441353|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
445481|NCT00502775|O1|Outcome|Placebo|
441354|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441355|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441356|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441357|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441358|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441359|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441360|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441361|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441362|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441363|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441364|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441365|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441366|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441367|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441368|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441369|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441370|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441371|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441372|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441373|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441374|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441375|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441376|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441377|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441378|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441379|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441380|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441381|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441382|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441383|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441384|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441385|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441386|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441387|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441388|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441389|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441390|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441391|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441392|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441393|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441394|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441395|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
445482|NCT00502775|E3|Reported Event|Fexofenadine 180 mg|
441396|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441397|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441398|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441399|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441400|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441401|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441402|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441403|NCT00515463|O2|Outcome|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe (PFS) on Day 1 and at Month 6.
441404|NCT00515463|O1|Outcome|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441405|NCT00515463|E2|Reported Event|Denosumab - Pre-filled Syringe|Participants received denosumab 60 mg subcutaneous injection using a pre-filled syringe on Day 1 and at Month 6.
441406|NCT00515463|E1|Reported Event|Denosumab - Vial|Participants received denosumab 60 mg subcutaneous injection using a standard vial on Day 1 and at Month 6.
441407|NCT00515437|B5|Baseline|Total|Total of all reporting groups
441408|NCT00515437|B4|Baseline|Placebo|Placebo
441409|NCT00515437|B3|Baseline|3500U Myobloc|3500U Myobloc
441410|NCT00515437|B2|Baseline|2500U Myobloc|2500U Myobloc
441411|NCT00515437|B1|Baseline|1500U Myobloc|1500U Myobloc
441412|NCT00515437|P4|Participant Flow|Placebo|Placebo
441413|NCT00515437|P3|Participant Flow|3500U Myobloc|3500U Myobloc
441414|NCT00515437|P2|Participant Flow|2500U Myobloc|2500U Myobloc
441415|NCT00515437|P1|Participant Flow|1500U Myobloc|1500U Myobloc
441416|NCT00515437|O4|Outcome|Placebo|Placebo
441417|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
441418|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
441419|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
441420|NCT00515437|O4|Outcome|Placebo|Placebo
441421|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
441422|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
441423|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
441424|NCT00515437|O4|Outcome|Placebo|Placebo
441425|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
441426|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
441427|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
441428|NCT00515437|O4|Outcome|Placebo|Placebo
441429|NCT00515437|O3|Outcome|3500U Myobloc|3500U Myobloc
441430|NCT00515437|O2|Outcome|2500U Myobloc|2500U Myobloc
441431|NCT00515437|O1|Outcome|1500U Myobloc|1500U Myobloc
441432|NCT00515437|E4|Reported Event|Placebo|Placebo
441433|NCT00515437|E3|Reported Event|3500U Myobloc|3500U Myobloc
441434|NCT00515437|E2|Reported Event|2500U Myobloc|2500U Myobloc
441435|NCT00515437|E1|Reported Event|1500U Myobloc|1500U Myobloc
441436|NCT00515216|B1|Baseline|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441437|NCT00515216|P1|Participant Flow|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
441438|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441439|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441440|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441441|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441442|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441443|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441444|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441503|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
441445|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441446|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441447|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441448|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441449|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441450|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441451|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441452|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|"“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype~Chemotherapy: 5-FU, leucovorin and oxaliplatin (FOLFOX)"
441453|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441454|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441455|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441456|NCT00515216|O1|Outcome|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441457|NCT00515216|E1|Reported Event|Oxaliplatin/Leucovorin/5-FU|“Good risk” patients with the TSER*2/*2 or *2/*3 genotype or low TS expression genotype received treatment of oxaliplatin, leucovorin given over 2 hours along with 5-FU given as intravenous push followed by 5-FU given as intravenous infusion of 46 hours. This treatment was repeated every 2 weeks.
441458|NCT00515203|B3|Baseline|Total|Total of all reporting groups
441459|NCT00515203|B2|Baseline|Placebo|Placebo by subcutaneous injection once weekly
441460|NCT00515203|B1|Baseline|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441461|NCT00515203|P2|Participant Flow|Placebo|Placebo by subcutaneous injection once weekly
441462|NCT00515203|P1|Participant Flow|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441463|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441464|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441465|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441466|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441467|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441468|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441469|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441470|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441471|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441472|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441473|NCT00515203|O2|Outcome|Placebo|Placebo by subcutaneous injection once weekly
441474|NCT00515203|O1|Outcome|Romiplostim|Romiplostim by subcutaneous injection once weekly at a starting dose of 1 µg/kg, adjusted based on weekly platelet counts to a maximum weekly dose of 10 µg/kg
441475|NCT00515203|E2|Reported Event|Romiplostim|
441476|NCT00515203|E1|Reported Event|Placebo|
441477|NCT00515177|B3|Baseline|Total|Total of all reporting groups
441480|NCT00515177|P2|Participant Flow|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441481|NCT00515177|P1|Participant Flow|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441482|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441483|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441484|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441485|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441486|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441487|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441488|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441489|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441490|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use."
441491|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441492|NCT00515177|O2|Outcome|Pharmacotherapy Control Arm|"A pharmacotherapy control arm (PCT) consisting of a state-of-the-art prescription sedative hypnotic, approved by the Food and Drug Administration for more than short term use.~eszopiclone : One 3 mg tablet of eszopiclone nightly for 8-weeks followed by 3-months of as needed use"
441493|NCT00515177|O1|Outcome|MBSR|"A Mindfulness-Based Stress Reduction (MBSR) program that includes 8-weeks of group instruction in mindfulness meditation techniques followed by home practice and monitoring.~Mindfulness-Based Stress Reduction : The intervention is a standardized program of mindfulness training led by an instructor. 8 weekly 2.5 hours sessions provide information on stress, cognition and health and training in a variety of mindfulness techniques including gentle yoga, body scan and sitting meditations. The program includes homework and home practice of mindfulness."
441494|NCT00515177|E2|Reported Event|MBSR|Mindfulness-Based Stress Reduction (MBSR) is an 8 week program of yoga and mindfulness training taught by a trained instructor in a group format.
441495|NCT00515177|E1|Reported Event|Pharmacotherapy (Eszopiclone, 3mg)|The PCT control treatment consisted of 3mg eszopiclone nightly for 8 weeks, followed by use as needed for 3 months.
441496|NCT00515112|B3|Baseline|Total|Total of all reporting groups
441497|NCT00515112|B2|Baseline|Placebo|"Three subjects received the placebo~Placebo: placebo"
441498|NCT00515112|B1|Baseline|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
441499|NCT00515112|P2|Participant Flow|Placebo|"Three subjects received the placebo~Placebo: placebo"
441500|NCT00515112|P1|Participant Flow|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
441501|NCT00515112|O2|Outcome|Placebo|"Three subjects received the placebo~Placebo: placebo"
441506|NCT00515112|E1|Reported Event|Androgel|"Three subjects received testosterone gel~AndroGel: Androgel 1%, 10g daily"
441507|NCT00515099|B3|Baseline|Total|Total of all reporting groups
441508|NCT00515099|B2|Baseline|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441509|NCT00515099|B1|Baseline|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441510|NCT00515099|P2|Participant Flow|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441511|NCT00515099|P1|Participant Flow|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441512|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441513|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441514|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441515|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441516|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441517|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441518|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441519|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441520|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441521|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441522|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441523|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441524|NCT00515099|O2|Outcome|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441525|NCT00515099|O1|Outcome|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4, 2 mg/kg.
441526|NCT00515099|E2|Reported Event|Placebo|This group received a saline solution administered intravenously to match the antithymocyte globulin (Thymoglobulin®) doses given to the active treatment group, on Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
441527|NCT00515099|E1|Reported Event|Antithymocyte Globulin|This group received a total of 6.5 mg/kg of antithymocyte globulin (Thymoglobulin®) administered intravenously and divided into four doses as follows: Day 1, 0.5 mg/kg; Day 2, 2 mg/kg; Day 3, 2 mg/kg; and Day 4 2 mg/kg.
441528|NCT00515086|B5|Baseline|Total|Total of all reporting groups
441529|NCT00515086|B4|Baseline|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441530|NCT00515086|B3|Baseline|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441531|NCT00515086|B2|Baseline|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441532|NCT00515086|B1|Baseline|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
441577|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441533|NCT00515086|P4|Participant Flow|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441534|NCT00515086|P3|Participant Flow|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441535|NCT00515086|P2|Participant Flow|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441536|NCT00515086|P1|Participant Flow|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
441537|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441538|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441539|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441540|NCT00515086|O3|Outcome|Total : No Surgery|Total participants enrolled with recurrent glioblastoma multiforme (GBM) who were not scheduled to undergo a planned salvage surgical resection. All participants in this arm were to receive a fixed daily dose of 10 mg/day oral everolimus.
441541|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme (GBM) with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
441542|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
441543|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441544|NCT00515086|O2|Outcome|Everolimus 5mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441545|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441546|NCT00515086|O4|Outcome|Total|All the participants scheduled to undergo salvage surgical resection from three pre-surgery treatment groups (i.e 0, 5 or 10 mg/day (once daily) everolimus X 7 days).
441547|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441548|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441549|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441550|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441551|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441552|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441553|NCT00515086|O2|Outcome|No Surgery ( ≥ 2 Previous Relapses)|Participants with recurrent Glioblastoma Multiforme with ≥ 2 previous relapses not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus until evidence of disease progression or toxicity.
441554|NCT00515086|O1|Outcome|No Surgery (1 Previous Relapse)|Participants with recurrent Glioblastoma Multiforme (GBM) with 1 previous relapse not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
441555|NCT00515086|O3|Outcome|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441578|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441556|NCT00515086|O2|Outcome|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441557|NCT00515086|O1|Outcome|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441558|NCT00515086|E4|Reported Event|No Surgery (Everolimus 10 mg)|Participants with recurrent Glioblastoma Multiforme (GBM) not scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus (RAD001) until evidence of disease progression or toxicity.
441559|NCT00515086|E3|Reported Event|Everolimus 0 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received no treatment with Everolimus prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441560|NCT00515086|E2|Reported Event|Everolimus 5 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 5 mg Everolimus for 7 days prior to surgery, then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441561|NCT00515086|E1|Reported Event|Everolimus 10 mg + Surgery|Participants scheduled to undergo salvage surgical resection, received a daily oral dose of 10 mg Everolimus for 7 days prior to surgery then after recovery from surgery received a 10 mg daily oral dose of Everolimus until evidence of disease progression or toxicity.
441562|NCT00515073|B1|Baseline|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
441563|NCT00515073|P1|Participant Flow|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
441564|NCT00515073|O1|Outcome|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
441565|NCT00515073|E1|Reported Event|Paclitaxel (Taxol) + Pelvic Radiation|"Paclitaxel (Taxol) 50 mg/m^2 intravenous (IV) weekly over 1 hour for 5 weeks. Radiation therapy to the pelvis daily for 25 treatments.~Both radiation therapy and paclitaxel chemotherapy on Day 1 or 2, followed by radiation alone for four days, repeated every week for a total of 5 weeks, giving a total dose of 45 Gy with external beam radiation to pelvis and 5 courses of paclitaxel 50 mg/m^2. Four-six weeks after pelvic radiation completed, 4 additional courses of paclitaxel 135 mg/m^2 alone given every 21 days. Vaginal apex boost given either with last 3 external beam treatments or after external beam radiation completed for additional 3 days. No chemotherapy given with vaginal apex boost.~Dexamethasone 20 mg, Diphenhydramine 50 mg and Cimetidine 300 mg IV 30 minutes prior to chemotherapy."
441566|NCT00515034|B5|Baseline|Total|Total of all reporting groups
441567|NCT00515034|B4|Baseline|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441568|NCT00515034|B3|Baseline|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441569|NCT00515034|B2|Baseline|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441570|NCT00515034|B1|Baseline|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441571|NCT00515034|P4|Participant Flow|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441572|NCT00515034|P3|Participant Flow|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441573|NCT00515034|P2|Participant Flow|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441574|NCT00515034|P1|Participant Flow|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441575|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441576|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441579|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441580|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441581|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441582|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441583|NCT00515034|O4|Outcome|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441584|NCT00515034|O3|Outcome|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441585|NCT00515034|O2|Outcome|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441586|NCT00515034|O1|Outcome|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441587|NCT00515034|E4|Reported Event|cIAI Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441588|NCT00515034|E3|Reported Event|cIAI Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with complicated Intra-Abdominal Infection (cIAI) for 5-14 days
441589|NCT00515034|E2|Reported Event|VAP Treated With Imipenem/Cilastatin|Imipenem/cilastatin 1 g infused over 1 hour at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP)for 7-14 days
441590|NCT00515034|E1|Reported Event|VAP Treated With Doripenem|Doripenem 1 g infused over 4 hours at 8-hour intervals for patients with Ventilator-Associated Pneumonia (VAP) for 7-14 days
441591|NCT00515008|B3|Baseline|Total|Total of all reporting groups
441592|NCT00515008|B2|Baseline|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441593|NCT00515008|B1|Baseline|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441594|NCT00515008|P2|Participant Flow|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program. Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks. At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyalgia, including the diagnostic criteria; coping strategies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physical and mental health; exercise; and wellness and lifestyle management. For the final 20 minutes of each class, participants practiced stretching exercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day.
441595|NCT00515008|P1|Participant Flow|Tai Chi Group|12-week Tai Chi Program.: The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 minutes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and techniques. In subsequent sessions, participants practiced 10 forms from the classic Yang style of tai chi under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the intervention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
441596|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441597|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441598|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441599|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441600|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441601|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441602|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441603|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441604|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441605|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441606|NCT00515008|O2|Outcome|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441607|NCT00515008|O1|Outcome|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441608|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
441627|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441852|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441609|NCT00515008|O1|Outcome|Tai Chi|The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks.
441610|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
441611|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
441612|NCT00515008|O2|Outcome|Control Group|"Our wellness education and stretching program similarly included 60-minute sessions held twice a week for 12 weeks.19 At each session, a variety of health professionals provided a 40-minute didactic lesson on a topic relating to fibromyal- gia, including the diagnostic criteria; coping strat- egies and problem-solving techniques; diet and nutrition; sleep disorders and fibromyalgia; pain management, therapies, and medications; physi- cal and mental health; exercise; and wellness and~lifestyle management.20 For the final 20 minutes of each class, participants practiced stretching ex- ercises supervised by the research staff. Stretches involved the upper body, trunk, and lower body and were held for 15 to 20 seconds. Participants were instructed to practice stretching at home for 20 minutes a day."
441613|NCT00515008|O1|Outcome|Tai Chi|"The tai chi intervention took place twice a week for 12 weeks, and each session lasted for 60 min- utes. Classes were taught by a tai chi master with more than 20 years of teaching experience. In the first session, he explained the theory behind tai~chi and its procedures and provided participants with printed materials on its principles and tech- niques. In subsequent sessions, participants prac- ticed 10 forms from the classic Yang style of tai chi18 under his instruction. Each session included a warm-up and self-massage, followed by a review of principles, movements, breathing techniques, and relaxation in tai chi. Throughout the inter- vention period, participants were instructed to practice tai chi at home for at least 20 minutes each day. At the end of the 12-week intervention, participants were encouraged to maintain their tai chi practice, using an instructional DVD, up until the follow-up visit at 24 weeks."
441614|NCT00515008|E2|Reported Event|Control Group|12-week Stretching and Wellness Education Program: Non-TC informational program
441615|NCT00515008|E1|Reported Event|Tai Chi Group|12-week Tai Chi Program.: 12-week Tai Chi classes
441616|NCT00514943|B3|Baseline|Total|Total of all reporting groups
441617|NCT00514943|B2|Baseline|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441618|NCT00514943|B1|Baseline|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441619|NCT00514943|P2|Participant Flow|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441620|NCT00514943|P1|Participant Flow|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441621|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441622|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441623|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
441624|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441625|NCT00514943|O2|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441626|NCT00514943|O1|Outcome|Afatinib 40 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1, and had sequential dose reduction to 40 mg in stage 1.
441628|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441629|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441630|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441631|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
441632|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441633|NCT00514943|O4|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441634|NCT00514943|O3|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441635|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
441636|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441637|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1
441638|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg in stage 1
441639|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 / Afatinib 50 mg|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441640|NCT00514943|O1|Outcome|Afatinib 50 mg / Cetuximab 250mg/m2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441641|NCT00514943|O2|Outcome|Cetuximab mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441642|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441643|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441644|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441645|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441646|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441647|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441648|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441649|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441650|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441651|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441652|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441653|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441654|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441655|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441656|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
445483|NCT00502775|E2|Reported Event|Fluticasone Furoate 110mcg|
441657|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441658|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441659|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441660|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
441661|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441662|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441663|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441664|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441665|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441666|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441667|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441668|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2
441669|NCT00514943|O2|Outcome|Cetuximab 250 mg/m2 - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1.
441670|NCT00514943|O1|Outcome|Afatinib 50 mg - Stage 1|Patients were randomised to receive Afatinib 50 mg once daily (q.d.) in Stage 1.
441671|NCT00514943|E4|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 1|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441672|NCT00514943|E3|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 2|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
441673|NCT00514943|E2|Reported Event|Afatinib 50 mg / Cetuximab 250mg/m2 - Stage 2|Patients were randomized to Afatinib monotherapy 50mg once daily (q.d.) in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Cetuximab 250 mg/m2 given as 400mg/m2 once in the first week (load) followed by 250mg/m2 weekly thereafter in Stage 2.
441674|NCT00514943|E1|Reported Event|Cetuximab 250 mg/m2 / Afatinib 50 mg - Stage 1|Patients were randomized to Cetuximab 250 mg/m2 received 400mg/m2 once in the first week followed by 250 mg/m2 weekly thereafter in Stage 1 and if the patients had disease progression or intolerable AEs were crossed over to Afatinib 50 mg once daily (q.d.) for Stage 2.
441675|NCT00514917|B3|Baseline|Total|Total of all reporting groups
441676|NCT00514917|B2|Baseline|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441677|NCT00514917|B1|Baseline|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441678|NCT00514917|P2|Participant Flow|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441679|NCT00514917|P1|Participant Flow|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441680|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441681|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441682|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441710|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441711|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441683|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441684|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441685|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441686|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441687|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441688|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441689|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441690|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441691|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441692|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441693|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441694|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441695|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441696|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441697|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441698|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg/m^2 subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441699|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles along with leuprolide 22.5 mg/m^2subcutaneous injection for every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441700|NCT00514917|O2|Outcome|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441701|NCT00514917|O1|Outcome|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441702|NCT00514917|E2|Reported Event|Leuprolide+Bicalutamide|Participants received leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441703|NCT00514917|E1|Reported Event|Docetaxel+Leuprolide+Bicalutamide|Participants received docetaxel 75 milligram per square meter (mg/m^2) intravenous infusion over 1 hour every 3 weeks up to 10 cycles (3 week cycle) along with leuprolide 22.5 mg injection subcutaneously every 12 weeks up to 18 months and bicalutamide 50 mg tablet orally once daily for first 4 weeks of treatment.
441704|NCT00514852|B3|Baseline|Total|Total of all reporting groups
441705|NCT00514852|B2|Baseline|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441706|NCT00514852|B1|Baseline|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441707|NCT00514852|P2|Participant Flow|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441708|NCT00514852|P1|Participant Flow|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441709|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441712|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441713|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441714|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441715|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441716|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441717|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441718|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441719|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441720|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441721|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441722|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441723|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441724|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441725|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441726|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441727|NCT00514852|O2|Outcome|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441728|NCT00514852|O1|Outcome|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441729|NCT00514852|E2|Reported Event|Carboxymethylcellulose Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441730|NCT00514852|E1|Reported Event|Carboxymethylcellulose and Glycerin Based Artificial Tear|1 to 2 drops into each eye as needed but at least twice daily
441731|NCT00514813|B5|Baseline|Total|Total of all reporting groups
441732|NCT00514813|B4|Baseline|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441733|NCT00514813|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441734|NCT00514813|B2|Baseline|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441735|NCT00514813|B1|Baseline|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441736|NCT00514813|P4|Participant Flow|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441737|NCT00514813|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441738|NCT00514813|P2|Participant Flow|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441739|NCT00514813|P1|Participant Flow|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441740|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441741|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441742|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441743|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441744|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441745|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441746|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441747|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441748|NCT00514813|O4|Outcome|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441749|NCT00514813|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441750|NCT00514813|O2|Outcome|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441751|NCT00514813|O1|Outcome|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441752|NCT00514813|E4|Reported Event|Dynepo Once Every 4 Weeks (Q4W)|Epoetin delta dosed once every 4 weeks
441753|NCT00514813|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|Epoetin delta dosed once every 2 weeks
441754|NCT00514813|E2|Reported Event|Dynepo Once Weekly (QW)|Epoetin delta dosed once-a-week
441755|NCT00514813|E1|Reported Event|Dynepo (Epoetin Delta) Twice Weekly (BIW)|Epoetin delta (Dynepo) dosed twice-a-week
441756|NCT00514735|B3|Baseline|Total|Total of all reporting groups
441757|NCT00514735|B2|Baseline|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441785|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of DTaP-Hep B-PRP-T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441786|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441853|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441758|NCT00514735|B1|Baseline|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441759|NCT00514735|P2|Participant Flow|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441760|NCT00514735|P1|Participant Flow|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441761|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441762|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441763|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441764|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441765|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441766|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441767|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441787|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441854|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
445484|NCT00502775|E1|Reported Event|Placebo|
441768|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441769|NCT00514735|O1|Outcome|Ablation Management|
441770|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441771|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441772|NCT00514735|O1|Outcome|Ablation Management|
441773|NCT00514735|O2|Outcome|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441774|NCT00514735|O1|Outcome|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441775|NCT00514735|E2|Reported Event|Medical Management|Medical Management subjects were prescribed Class I or III antiarrhythmic drugs. Changes in dosing, antiarrhythmic drugs or combinations of antiarrhythmic drugs were allowed. Direct current (DC) cardioversions were also allowed at the discretion of the investigator. Anticoagulation was to be maintained at an International Normalized Ratio greater than 2. Subjects were seen at in-clinic follow-up visits at 1, 3, and 6 months. Subjects who demonstrated chronic treatment failure while under drug therapy could cross over, and receive an ablation as early as 4 months post randomization.
441776|NCT00514735|E1|Reported Event|Ablation Management|Pre- and post- procedure anticoagulation was managed according to the preference of the investigator. Left atrial access was obtained by a single transseptal puncture. No ablations were to occur until the activated clotting time reached 300 seconds, which was to be maintained for the duration of the ablation. During the index ablation procedure, investigators were required to use all 3 investigational catheters. Cardioversion could be used to restore sinus rhythm if needed. If there was a recurrence of atrial fibrillation, a repeat ablation procedure could be performed any time during the follow-up period. With a retreatment, the follow-up clock was restarted. Subjects were seen pre-discharge and at in-clinic follow-up visits at 1, 3, and 6 months.
441777|NCT00514709|B3|Baseline|Total|Total of all reporting groups
441778|NCT00514709|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441779|NCT00514709|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441780|NCT00514709|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
441781|NCT00514709|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201 (NCT00348881).
441782|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441783|NCT00514709|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441784|NCT00514709|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine following a 3-dose primary series of Tritanrix-Hep B/ Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441788|NCT00514709|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of Tritanrix-Hep B/Hib™ concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441789|NCT00514709|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received a booster dose of the DTaP-Hep B-PRP~T Combined vaccine concomitantly with oral polio vaccine (OPV) following a 3-dose primary series of DTaP-Hep B-PRP~T combined vaccine concomitantly with OPV at 6, 10, and 14 weeks of age in Study AL201.
441790|NCT00514683|B6|Baseline|Total|Total of all reporting groups
441791|NCT00514683|B5|Baseline|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441792|NCT00514683|B4|Baseline|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441793|NCT00514683|B3|Baseline|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441794|NCT00514683|B2|Baseline|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441795|NCT00514683|B1|Baseline|Placebo|Patients were treated with matching Placebo.
441796|NCT00514683|P5|Participant Flow|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441797|NCT00514683|P4|Participant Flow|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441798|NCT00514683|P3|Participant Flow|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441799|NCT00514683|P2|Participant Flow|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441800|NCT00514683|P1|Participant Flow|Placebo|Patients were treated with matching Placebo.
441801|NCT00514683|O4|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441802|NCT00514683|O3|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441803|NCT00514683|O2|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441804|NCT00514683|O1|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441805|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441806|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441807|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441808|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441809|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441810|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441811|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441812|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441813|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441814|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441815|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441816|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441817|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441818|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441819|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441820|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441821|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441822|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441823|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441824|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441825|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441826|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441827|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441828|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441829|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441830|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441831|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441832|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441833|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441834|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441835|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441836|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441837|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441838|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441839|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441840|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441841|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441842|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441843|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441844|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441845|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441846|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441847|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441855|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441856|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441857|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441858|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441859|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441860|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441861|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441862|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441863|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441864|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441865|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441866|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441867|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441868|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441869|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441870|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441871|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441872|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441873|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441874|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441875|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441876|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441877|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441878|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441879|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441880|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441881|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441882|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441883|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441884|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441885|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441886|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441887|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441888|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441889|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441890|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441891|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441892|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441893|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441894|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441895|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441896|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441897|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441898|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441899|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441900|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441901|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441902|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441903|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441904|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441905|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441906|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441907|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441908|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441909|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441910|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441911|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441912|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441913|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441914|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441915|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441916|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441917|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441918|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441919|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441920|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441921|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441922|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441923|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441924|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441925|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441926|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441927|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441928|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441929|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441930|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441931|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441932|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441933|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441934|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441935|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441936|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441937|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441938|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441939|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441940|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441941|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441942|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441943|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441944|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441945|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441946|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441947|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441948|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441949|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441950|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441951|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441952|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441953|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441954|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441955|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441956|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441957|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441958|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441959|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441960|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441961|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441962|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441963|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441964|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441965|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441966|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441967|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441968|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441969|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441970|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441971|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441972|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441973|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441974|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441975|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441976|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441977|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441978|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441979|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441980|NCT00514683|O5|Outcome|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441981|NCT00514683|O4|Outcome|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441982|NCT00514683|O3|Outcome|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441983|NCT00514683|O2|Outcome|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441984|NCT00514683|O1|Outcome|Placebo|Patients were treated with matching Placebo.
441985|NCT00514683|E5|Reported Event|Nintedanib 150 Bid|Patients were treated with 150mg nintedanib twice daily
441986|NCT00514683|E4|Reported Event|Nintedanib 100 Bid|Patients were treated with 100mg nintedanib twice daily
441987|NCT00514683|E3|Reported Event|Nintedanib 50 Bid|Patients were treated with 50mg nintedanib twice daily
441988|NCT00514683|E2|Reported Event|Nintedanib 50 qd|Patients were treated with 50mg nintedanib once daily
441989|NCT00514683|E1|Reported Event|Placebo|Patients were treated with matching Placebo.
441990|NCT00514592|B1|Baseline|All Patients|All patients are in the same group
441991|NCT00514592|P1|Participant Flow|All Patients|All patients enter the same group
441992|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
441993|NCT00514592|O1|Outcome|All Patients|All patients enter the same group
441994|NCT00514592|E1|Reported Event|All Patients|All patients enter the same group
441995|NCT00514514|B4|Baseline|Total|Total of all reporting groups
441996|NCT00514514|B3|Baseline|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
441997|NCT00514514|B2|Baseline|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
441998|NCT00514514|B1|Baseline|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
441999|NCT00514514|P3|Participant Flow|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442000|NCT00514514|P2|Participant Flow|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442001|NCT00514514|P1|Participant Flow|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442002|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442003|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442004|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442005|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442006|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442007|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442008|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442009|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442010|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442011|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442012|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442013|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442014|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442015|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442016|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442017|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442018|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442019|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442020|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442021|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442022|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442023|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442024|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442025|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442026|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442027|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442028|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442029|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442030|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442031|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442032|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442033|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442034|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442035|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442036|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442037|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442038|NCT00514514|O3|Outcome|CNI Low Regimen|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: everolimus 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: everolimus 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442039|NCT00514514|O2|Outcome|CNI Free Regimen|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, everolimus 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, everolimus 3 mg and corticosteroids"
442040|NCT00514514|O1|Outcome|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442041|NCT00514514|E3|Reported Event|CNI-low|"CNI low regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Certican 1.5 mg, Sandimmun Optoral and corticosteroids Step 2 at BL2 + 8 days: Certican 1.5 mg, Sandimmun Optoral (low dose) and corticosteroids"
442042|NCT00514514|E2|Reported Event|CNI-free|"CNI free regimen: comprising the following steps for switching treatment:~Step 1 at BL2 + 1 day: Myfortic, Certican 1.5 mg, Sandimmun Optoral (50% of standard dose) and corticosteroids Step 2 at BL2 + 8 days: Myfortic, Certican 3 mg and corticosteroids"
442043|NCT00514514|E1|Reported Event|Standard Regimen|Myfortic, Sandimmun Optoral and corticosteroids
442044|NCT00514501|B1|Baseline|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442045|NCT00514501|P1|Participant Flow|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442046|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442047|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442048|NCT00514501|O1|Outcome|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442049|NCT00514501|E1|Reported Event|Iodofiltic Acid I 123|A single IV dose of iodofiltic acid I 123 (approximately 4.0-5.0 mCi) was injected through an indwelling catheter, followed by 10 mL of normal saline to complete delivery of the dose.
442050|NCT00514215|B1|Baseline|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
445485|NCT00502697|B3|Baseline|Total|Total of all reporting groups
442051|NCT00514215|P1|Participant Flow|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
442052|NCT00514215|O1|Outcome|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
442053|NCT00514215|E1|Reported Event|Sargramostim, Flow Cytometry, Biopsy. Cryosurgery|"Sargramostim-250 μg, inhaled, two times a day, on days 4-10 and days 36-42 Flow cytometry-Days 1 & 32 Immunoenzyme technique-Days 1 & 32 CT guided biopsy-Days 1 & 32 Cryosurgery-Days 1 and 32~sargramostim: 250 μg, inhaled, two times a day, on days 4-10 and days 36-42~flow cytometry: Days 1 & 32~immunoenzyme technique: Days 1 & 32~biopsy: CT guided biopsy on days 1 & 32~cryosurgery: Days 1 and 32"
442054|NCT00514137|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442055|NCT00514137|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442056|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442057|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442058|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442059|NCT00514137|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442060|NCT00514137|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral sunitinib malate once daily on days 1-42. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
442061|NCT00514020|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
442062|NCT00514020|P1|Participant Flow|5-FU, Leucovorin, Oxaliplatin|"Patients who have TSER*2/*2 or TSER*2/*3 genotypes will receive the modified FOLFOX-6 treatment. Patients homozygous for TSER*3 will not be included in study.~FOLFOX-6 chemotherapy: oxaliplatin IV in 500 ml D5W over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15.~Treatment courses repeat every 2 weeks +/- 3 days (2 treatments per cycle) in the absence of unacceptable toxicity or disease progression. Disease assessments will be performed after 8 weeks (2 cycles) of treatment."
442063|NCT00514020|O1|Outcome|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
442064|NCT00514020|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Patients receive oxaliplatin IV over 2 hours, leucovorin calcium intravenously (IV) over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15. Courses repeat every 2 weeks in the absence of unacceptable toxicity or disease progression.
442065|NCT00513799|B5|Baseline|Total|Total of all reporting groups
442066|NCT00513799|B4|Baseline|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
442067|NCT00513799|B3|Baseline|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
442068|NCT00513799|B2|Baseline|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
442069|NCT00513799|B1|Baseline|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
442070|NCT00513799|P4|Participant Flow|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
442071|NCT00513799|P3|Participant Flow|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
442072|NCT00513799|P2|Participant Flow|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
442315|NCT00513240|O1|Outcome|EPO 1000 Units/kg QDx3|Original dose of 1000 units/kg every day for 3 doses
442073|NCT00513799|P1|Participant Flow|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
442074|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442075|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442076|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442077|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442078|NCT00513799|O4|Outcome|4: Education + Mupirocin + Bleach Baths|"A combination of nasal application of mupirocin and bathing in dilute bleach water~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Bleach baths (dilute): Pour 2 ounces of bleach into water-filled bath tub. Soak in bath for 15 minutes. Apply once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442079|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|"A combination of nasal application of mupirocin and chlorhexidine showers~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Chlorhexidine showers: Apply Clorhexidine wash to entire body once daily for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442080|NCT00513799|O2|Outcome|2: Hygiene Education + Mupirocin|"Application of mupirocin in the nasal mucosa alone~Mupirocin ointment: Add a small amount of Mupirocin to the cotton end of a swab. Swab in inner nostril, then repeat in other nostril using new cotton swab with ointment. Twice daily treatment for 5 days.~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442081|NCT00513799|O1|Outcome|1: Hygiene Education|"Intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)~Intensive education on personal hygiene: Repeat hygiene methods for 5 days."
442082|NCT00513799|O4|Outcome|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
442083|NCT00513799|O3|Outcome|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
442084|NCT00513799|O2|Outcome|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
442085|NCT00513799|O1|Outcome|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
442086|NCT00513799|E4|Reported Event|Education + Mupirocin + Bleach Baths|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed bleach bath to entire body once daily for 5 days (instructed to pour 2 ounces of bleach into water-filled bath tub and soak in bath for 15 minutes).
442087|NCT00513799|E3|Reported Event|Education + Mupirocin + Chlorhexidine|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days AND prescribed Chlorhexidine wash to entire body once daily for 5 days.
442088|NCT00513799|E2|Reported Event|Hygiene Education + Mupirocin|Participants administered an intensive education on prevention of skin infections through improvements in personal hygiene AND prescribed Mupirocin ointment applied to the nasal mucosa twice daily for 5 days
442089|NCT00513799|E1|Reported Event|Hygiene Education|"Participants only administered an intensive education on prevention of skin infections through improvements in personal hygiene (also serves as control group)"
442090|NCT00513708|B4|Baseline|Total|Total of all reporting groups
442091|NCT00513708|B3|Baseline|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442092|NCT00513708|B2|Baseline|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442093|NCT00513708|B1|Baseline|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442246|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442094|NCT00513708|P3|Participant Flow|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442095|NCT00513708|P2|Participant Flow|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442096|NCT00513708|P1|Participant Flow|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442097|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442098|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442099|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442100|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442101|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442102|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442103|NCT00513708|O3|Outcome|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442104|NCT00513708|O2|Outcome|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442105|NCT00513708|O1|Outcome|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442106|NCT00513708|E3|Reported Event|Peer-delivered Twelve Step Facilitation|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Peer-delivered Twelve Step Facilitation (P-TSF)session delivered by individuals from a common self-help program."
442107|NCT00513708|E2|Reported Event|Motivational Enhancement Therapy|"Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during inpatient detoxification plus a 60-minute Motivational Enhancement Therapy (MET) session delivered by a trained professional."
442108|NCT00513708|E1|Reported Event|Treatment as Usual|"Treatment as Usual (TAU): Participants randomized to this arm will receive usual care (i.e., pharmacotherapy to manage alcohol withdrawal, counseling and referral to treatment or self-help) during medically managed inpatient detoxification."
442109|NCT00513682|B1|Baseline|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
442110|NCT00513682|P1|Participant Flow|Ultrase® MT20|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet. Then the treatment phase was started which consisted of a stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (lipase units/kg/meal).
442111|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
442112|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
442113|NCT00513682|O2|Outcome|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
442114|NCT00513682|O1|Outcome|Ultrase® MT20 Washout Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea. This was followed by a washout phase of 6 to 7 days, in which participants received only high-fat diet.
442115|NCT00513682|E3|Reported Event|Ultrase® MT20 Treatment Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent washout phase, received stabilized dose of Ultrase® MT20 capsule (as identified during screening phase) orally for 7 to 11 days during treatment phase. The stabilized dose not to exceed 2500 lipase units per kilogram body weight per meal (unit/kg/meal).
442116|NCT00513682|E2|Reported Event|Ultrase® MT20 Washout Phase|Participants who received Ultrase® MT20 capsules orally in screening phase and underwent a washout phase, of 6 to 7 days, in which participants received only high-fat diet and refrained from taking Ultrase® MT20.
442117|NCT00513682|E1|Reported Event|Ultrase® MT20 Screening Phase|Ultrase® MT20 capsules orally with each meal during Day 1 to 15 in screening phase at a dose based on investigator's discretion. During Day 12 to 15, participants received high-fat diet and Ultrase® MT20 dose was adjusted depending on symptoms of steatorrhea.
442118|NCT00513617|B4|Baseline|Total|Total of all reporting groups
442119|NCT00513617|B3|Baseline|Placebo|
442120|NCT00513617|B2|Baseline|High Dose|0.10 g/kg/day of Arginine in capsule form
442121|NCT00513617|B1|Baseline|Low Dose|0.05 g/kg/day of Arginine in capsule form
442122|NCT00513617|P3|Participant Flow|Placebo|
442123|NCT00513617|P2|Participant Flow|High Dose|0.10 g/kg/day of Arginine in capsule form
442124|NCT00513617|P1|Participant Flow|Low Dose|0.05 g/kg/day of Arginine in capsule form
442125|NCT00513617|O3|Outcome|Placebo|
442126|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
442127|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
442128|NCT00513617|O3|Outcome|Placebo|
442129|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
442130|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
442131|NCT00513617|O3|Outcome|Placebo|
442132|NCT00513617|O2|Outcome|High Dose|0.10 g/kg/day of Arginine in capsule form
442133|NCT00513617|O1|Outcome|Low Dose|0.05 g/kg/day of Arginine in capsule form
442134|NCT00513604|B6|Baseline|Total|Total of all reporting groups
442135|NCT00513604|B5|Baseline|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
442136|NCT00513604|B4|Baseline|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442137|NCT00513604|B3|Baseline|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442138|NCT00513604|B2|Baseline|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442139|NCT00513604|B1|Baseline|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442140|NCT00513604|P5|Participant Flow|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
442141|NCT00513604|P4|Participant Flow|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442142|NCT00513604|P3|Participant Flow|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442143|NCT00513604|P2|Participant Flow|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442144|NCT00513604|P1|Participant Flow|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442145|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
442146|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442147|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442148|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442149|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442150|NCT00513604|O5|Outcome|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
442151|NCT00513604|O4|Outcome|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442152|NCT00513604|O3|Outcome|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442153|NCT00513604|O2|Outcome|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442247|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442154|NCT00513604|O1|Outcome|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442155|NCT00513604|E5|Reported Event|Cohort 5 - NMA, CD4+TIL, HD Aldesleukin|"Cohort 5 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) tumor infiltrating lymphocytes (TIL), high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days"
442156|NCT00513604|E4|Reported Event|Cohort 4 - NMA, Young TIL, Aldesleukin|"Cohort 4 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442157|NCT00513604|E3|Reported Event|Cohort 3 - NMA, Total Body Irradiation|"Cohort 3 - Nonmyeloablative (NMA), total body irradiation (TBI):~Nonmyeloablative chemotherapeutic conditioning regimen and 2 gray units (Gy) of total body irradiation followed by cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL 2Gy (gray units) of total body irradiation (TBI) twice on day -2 and once on day -1 (total dose 6 Gy) at a rate of 0.07 Gy/minute using a linear accelerator in Radiation Oncology Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442158|NCT00513604|E2|Reported Event|Cohort 2 - NMA, CD4+ TIL, Aldesleukin|"Cohort 2 - Nonmyeloablative (NMA), cluster of differentiation 4 (CD4+) depleted tumor infiltrating lymphocytes (TIL), aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by CD4+ depleted tumor infiltrating lymphocytes and high dose (HD) aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. CD4+ depleted TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442159|NCT00513604|E1|Reported Event|Cohort 1 - NMA, TIL, Aldesleukin|"Cohort 1 - Nonmyeloablative (NMA), tumor infiltrating lymphocytes (TIL), & high dose (HD) aldesleukin:~Nonmyeloablative chemotherapeutic conditioning regimen followed by bulk young tumor infiltrating lymphocytes and high dose aldesleukin.~Cyclophosphamide 60 mg/kg intravenous (IV) daily x 2 days. Fludarabine 25 mg/m^2 intravenous (IV) daily x 5 days. Bulk young TIL Aldesleukin 720,000 IU/kg intravenous (IV) (based on body weight) over 15 minutes every eight hours for up to 5 days."
442160|NCT00513526|B1|Baseline|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
442161|NCT00513526|P1|Participant Flow|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
442162|NCT00513526|O1|Outcome|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
442163|NCT00513526|O1|Outcome|Gardasil|
442164|NCT00513526|O1|Outcome|Gardasil|
442165|NCT00513526|O1|Outcome|Gardasil|
442166|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
442167|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
442168|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
442169|NCT00513526|O1|Outcome|Gardasil|
442170|NCT00513526|O1|Outcome|Gardasil|
442171|NCT00513526|O1|Outcome|Gardasil|
442172|NCT00513526|O1|Outcome|Gardasil|Number of participants seropositive for HPV-6 at week 28 among those who were seronegative at baseline.
442173|NCT00513526|O1|Outcome|Gardasil|
442174|NCT00513526|E1|Reported Event|Gardasil|Quadrivalent HPV Vaccine (types 6, 11, 16, 18) for intramuscular injection at study entry, week 8, week 24, and week 128.
442175|NCT00513500|B3|Baseline|Total|Total of all reporting groups
442176|NCT00513500|B2|Baseline|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442177|NCT00513500|B1|Baseline|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442178|NCT00513500|P2|Participant Flow|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442179|NCT00513500|P1|Participant Flow|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442204|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442180|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442181|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442182|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442183|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442184|NCT00513500|O2|Outcome|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442185|NCT00513500|O1|Outcome|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442186|NCT00513500|E2|Reported Event|Current Practice|"Control: Treatment for malaria and pneumonia referral Treat malaria based on fever with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Refer children with pneumonia to the nearest health facility."
442187|NCT00513500|E1|Reported Event|Enhanced Treatment|"Intervention: Treatment for malaria and pneumonia:~Treat malaria based on rapid diagnostic test with half tablet (20mg artemether, 120mg lumefantrine) for children weighing 5-9.9kg and one tablet (20mg artemether, 120mg lumefantrine) for children weighing 10-20kg twice a day for three days.~Treat pneumonia with half tablet (250mg amoxicillin) for children weighing 5 - 9.9kg and one tablet (250mg amoxicillin for children weighing 10-20kg three times a day for five days."
442188|NCT00513435|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
442189|NCT00513435|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib 175 mg PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
442190|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
442191|NCT00513435|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
442192|NCT00513435|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive saracatinib PO or by PEG tube QD on days 1-56. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.
442193|NCT00513409|B3|Baseline|Total|Total of all reporting groups
442194|NCT00513409|B2|Baseline|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442195|NCT00513409|B1|Baseline|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442196|NCT00513409|P2|Participant Flow|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442197|NCT00513409|P1|Participant Flow|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442198|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442199|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442200|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442201|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442202|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442203|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
447098|NCT00496964|B3|Baseline|Total|Total of all reporting groups
442205|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442206|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442207|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442208|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442209|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442210|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442211|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442212|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442213|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442214|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442215|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442216|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442217|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442218|NCT00513409|O2|Outcome|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442219|NCT00513409|O1|Outcome|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442220|NCT00513409|E2|Reported Event|Synflorix Catch-up Group|Subjects previously primed with Havrix™ co-administered with Infanrix™ hexa and receiving in the current study Synflorix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442221|NCT00513409|E1|Reported Event|Synflorix Booster Group|Subjects previously primed with Synflorix™ and receiving in the current study Havrix™ co-administered with Infanrix™ hexa (Dose 1) and Synflorix™ (Dose 2).
442222|NCT00513370|B1|Baseline|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
442223|NCT00513370|P1|Participant Flow|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
442224|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442225|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442226|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442227|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442228|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442229|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442230|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442231|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442232|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442233|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442234|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442235|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442236|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442237|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442238|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442239|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442240|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442241|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442242|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 24 timepoint
442243|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442244|NCT00513370|O2|Outcome|Adalimumab 40 mg Eow - 24 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442245|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442248|NCT00513370|O1|Outcome|Adalimumab 40 mg Eow - 16 Weeks|adalimumab 40 mg every other week - Week 16 timepoint
442249|NCT00513370|E1|Reported Event|Adalimumab 40 mg Eow|adalimumab 40 mg every other week (eow)
442250|NCT00513357|B3|Baseline|Total|Total of all reporting groups
442251|NCT00513357|B2|Baseline|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
442252|NCT00513357|B1|Baseline|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
442253|NCT00513357|P2|Participant Flow|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
442254|NCT00513357|P1|Participant Flow|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
442255|NCT00513357|O2|Outcome|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
442256|NCT00513357|O1|Outcome|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
442257|NCT00513357|E2|Reported Event|Placebo|20 mg of placebo before going to sleep at night for a period of 4 weeks.
442258|NCT00513357|E1|Reported Event|Melatonin|20 mg of Melatonin before going to sleep at night for a period of 4 weeks.
442259|NCT00513344|B1|Baseline|Entire Study Population|Includes groups randomized to receive control first, milk chocolate first, and dark chocolate first
442260|NCT00513344|P1|Participant Flow|Each Subject Tested the Three Products Randomly Following|"Before the 1st intervention, no food with polyphenols was admitted~Each subject was administered the three products randomly(one product per one-day intervention) according to the six possible sequencies:~Either dark chocolate first, then milk chocolate then control~or dark chocolate first, then control, then milk chocolate~or control first, then dark chocolate, then milk chocolate~or Control first, then milk chocolate, then dark chocolate~or Milk chocolate first, then control, then dark chocolate~or milk chocolate first, then dark chocolate, then control r dark chocolate was given once in the morning (1 day) Products were administered in the morning of the testing day. The testing days (interventions) were separated by a three-day wash-out period."
442261|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
442262|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
442263|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
442264|NCT00513344|O3|Outcome|Dark Chocolate Containing Polyphenols|"dark chocolate~Dark Chocolate : 1 portion"
442265|NCT00513344|O2|Outcome|Milk Chocolate Containing Polyphenols|"Bespoke milk chocolate~Milk Chocolate : 1 portion"
442266|NCT00513344|O1|Outcome|Control Chocolate With no Polyphenols|"cocoa-free chocolate~Control (polyphenol-free)"
442267|NCT00513344|E3|Reported Event|Control|
442268|NCT00513344|E2|Reported Event|Milk Chocolate|
442269|NCT00513344|E1|Reported Event|Dark Chocolate|
442270|NCT00513305|B3|Baseline|Total|Total of all reporting groups
442271|NCT00513305|B2|Baseline|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442272|NCT00513305|B1|Baseline|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442273|NCT00513305|P2|Participant Flow|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442274|NCT00513305|P1|Participant Flow|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442275|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442276|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442277|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442278|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442279|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442280|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442281|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442310|NCT00513240|B1|Baseline|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
442314|NCT00513240|O2|Outcome|EPO 500 Units/kg QODx3|Revised dose after FDA clinical hold removed of EPO 500 units/kg every other day for 3 doses
442282|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442283|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442284|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442285|NCT00513305|O2|Outcome|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442286|NCT00513305|O1|Outcome|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442287|NCT00513305|E2|Reported Event|Low-dose Cytarabine Alone|Cytarabine was administered at a dose of 10 mg/m^2 sc bid from days 1-14 of cycle 1. A second identical cycle of cytarabine treatment was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved a complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine with the doses and schedule identical to the initial treatment cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of cytarabine at 10 mg/m^2 sc bid on days 1-7 of a 28-day cycle. Patients started maintenance treatment within 42 days after platelet count recovery. Maintenance treatment continued for 2 years or until unacceptable toxicity or disease progression.
442288|NCT00513305|E1|Reported Event|Low-dose Cytarabine Plus Arsenic Trioxide|Cycle 1. 10 mg/m^2 cytarabine was administered subcutaneously (sc) twice daily (bid) on days 1-14. 0.25 mg/kg arsenic trioxide was administered intravenously (iv) on days 1-5 and days 8-12. Cycle 2. A second identical cycle of cytarabine and arsenic trioxide was given to patients with persistent disease identified from a bone marrow sample taken on day 21 of cycle 1. Patients who achieved complete remission (CR), complete remission with incomplete platelet count recovery (CRp), or partial remission (PR) after 1 or 2 cycles received a 14-day consolidation cycle of cytarabine and arsenic trioxide with the doses and schedule identical to the initial cycle. A recovery period of up to 4 weeks between the attainment of CR, CRp, or PR and the initiation of consolidation treatment was allowed. Patients who completed consolidation treatment started maintenance treatment of arsenic trioxide 0.25 mg/kg iv on days 1 and 4 and cytarabine 10 mg/m^2 sc bid on days 1 through 7 of a 28-day cycle.
442289|NCT00513292|B3|Baseline|Total|Total of all reporting groups
442311|NCT00513240|P2|Participant Flow|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
442290|NCT00513292|B2|Baseline|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442291|NCT00513292|B1|Baseline|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442292|NCT00513292|P2|Participant Flow|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442293|NCT00513292|P1|Participant Flow|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442294|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442295|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442296|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442297|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442298|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442312|NCT00513240|P1|Participant Flow|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
442313|NCT00513240|O3|Outcome|Placebo|Placebo
442299|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442300|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442301|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442302|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442303|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442304|NCT00513292|O2|Outcome|Paclitaxel/Trastuzumab Then Trastuzumab/FEC-75|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442305|NCT00513292|O1|Outcome|FEC-75 Then Paclitaxel/Trastuzumab|Patients receive Fluorouracil, epirubicin, and cyclophosphamide (FEC) comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442306|NCT00513292|E2|Reported Event|Arm B|Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442307|NCT00513292|E1|Reported Event|Arm A|Patients receive FEC comprising fluorouracil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks. epirubicin hydrochloride: Given IV, cyclophosphamide: Given IV, paclitaxel: Given IV, trastuzumab: Given IV, therapeutic conventional surgery: Undergo surgery, laboratory biomarker analysis: Correlative studies
442308|NCT00513240|B3|Baseline|Total|Total of all reporting groups
442309|NCT00513240|B2|Baseline|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
447473|NCT00495677|B8|Baseline|Total|Total of all reporting groups
442316|NCT00513240|E2|Reported Event|Control Group.|"Patients randomized to receive 3 doses of normal saline control.~Normal saline: Normal saline placebo in 3 doses:dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2."
442317|NCT00513240|E1|Reported Event|EPO Group|"Patients randomized to receive the 3 doses of erythropoetin.~Erythropoetin: Erythropoetin 500 units/kg IV x 3 : dose 1. 12-72 hours preoperatively, dose 2. Postoperative day #1, 48 hours after separating from cardiopulmonary bypass, and dose 3. postoperative day #3, 48 hours after dose #2"
442318|NCT00513071|B1|Baseline|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
442319|NCT00513071|P1|Participant Flow|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
442320|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
442321|NCT00513071|O1|Outcome|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
442322|NCT00513071|E1|Reported Event|Treatment (Saracatinib)|"Patients receive oral AZD0530 at 175 mg once daily. Treatment repeats every 4 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity.~saracatinib: Given orally~laboratory biomarker analysis: Correlative studies"
442323|NCT00513019|B3|Baseline|Total|Total of all reporting groups
442324|NCT00513019|B2|Baseline|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
442325|NCT00513019|B1|Baseline|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
442326|NCT00513019|P2|Participant Flow|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
442327|NCT00513019|P1|Participant Flow|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
442328|NCT00513019|O2|Outcome|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
442329|NCT00513019|O1|Outcome|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
442330|NCT00513019|E2|Reported Event|Placebo|Placebo pills (identical to lamictal pills) were taken by mouth once daily.
442331|NCT00513019|E1|Reported Event|Lamictal|The subjects began lamotrigine at 25 mg/d every other day for 1 week. At week 1, the dose was raised to 25 mg/d. At week 2, the dose was raised to 50 mg/d for 2 weeks. Thereafter, all visits were scheduled every 2 weeks at which times the dose could be increased to 100 mg/d, then 200 mg/d, and finally 300 mg/d unless clinical improvement was attained at a lower dose (clinical improvement was assessed by the investigator with respect to skin picking behavior, thoughts, and urges).
442332|NCT00512902|B1|Baseline|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442333|NCT00512902|P1|Participant Flow|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442334|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442335|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442336|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442337|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442338|NCT00512902|O1|Outcome|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442339|NCT00512902|E1|Reported Event|Imatinib|Systemic Sclerosis patients administered oral 600 mg imatinib once per day for up to one year.
442340|NCT00512876|B1|Baseline|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
442341|NCT00512876|P1|Participant Flow|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
442342|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
442343|NCT00512876|O1|Outcome|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye either 2 or 4 times daily over a period of 3 weeks
442344|NCT00512876|E1|Reported Event|Topical Avastin 1.0%|Each participant received topical Avastin to be applied to the affected eye
442345|NCT00512798|B3|Baseline|Total|Total of all reporting groups
442346|NCT00512798|B2|Baseline|Phase II|
442347|NCT00512798|B1|Baseline|Phase I|
442348|NCT00512798|P2|Participant Flow|Phase II|PS-341 and Temozolomide will be administered in the same manner as in Phase I at doses as determined by the Phase I portion of the trial.
442349|NCT00512798|P1|Participant Flow|Phase I|PS-341 will be administered intravenously at 1.0 mg/m2 of body weight beginning on days 1, 4, 8, and 11 of every 21 days. If toxicity occurs, dose will be lowered to 0.7 mg/m2. Dose can be raised to a maximum of 1.5 mg/m2. Temozolomide will be orally administered daily at 50 mg/m2 of body weight beginning on day 8 for 6 weeks of every 9-week cycle, followed by a 3-week rest. Minimum dose is 50 mg/m2 and maximum dose is 75 mg/m2.
442350|NCT00512798|O1|Outcome|Phase II|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior treatment with Dacarbazine or Temozolomide with treatment failure.
442351|NCT00512798|O1|Outcome|Phase II|Phase II patients who were available for blood draw on the designated days.
442352|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
442353|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
442354|NCT00512798|O1|Outcome|Phase I|Patients with advanced, incurable melanoma who are chemotherapy-naive or patients who had undergone prior therapy with Dacarbazine or Temozolomide with treatment failure.
442355|NCT00512798|E2|Reported Event|Phase II|
442356|NCT00512798|E1|Reported Event|Phase I|
442357|NCT00512252|B4|Baseline|Total|Total of all reporting groups
442358|NCT00512252|B3|Baseline|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
442359|NCT00512252|B2|Baseline|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
442360|NCT00512252|B1|Baseline|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
442361|NCT00512252|P3|Participant Flow|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
442362|NCT00512252|P2|Participant Flow|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
442363|NCT00512252|P1|Participant Flow|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
442364|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442365|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442366|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
442367|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
442368|NCT00512252|O2|Outcome|Primary Refractory|
442369|NCT00512252|O1|Outcome|First Relapse, First Salvage|
442370|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442371|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442372|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
442373|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
442374|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
442375|NCT00512252|O3|Outcome|Phase I Dose Escalation - Dose Level 3|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
442376|NCT00512252|O2|Outcome|Phase I Dose Escalation - Dose Level 2|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
442377|NCT00512252|O1|Outcome|Phase I Dose Escalation - Dose Level 1|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
442378|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442379|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442380|NCT00512252|O1|Outcome|Phase II Dose Treatment|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose)"
442381|NCT00512252|O1|Outcome|Phase I Dose Escalation/Phase II Dose Treatment|
442382|NCT00512252|O4|Outcome|Total|Phase II Dose Patients
442383|NCT00512252|O3|Outcome|>= Second Relapse/Salvage|
442384|NCT00512252|O2|Outcome|Primary Refractory|
442385|NCT00512252|O1|Outcome|First Relapse, First Salvage|
442386|NCT00512252|O1|Outcome|Phase I Dose Escalation|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d~Dose Level 2 AMD3100 dose = 160 mcg/kg/d~Dose Level 3 AMD3100 dose = 240 mcg/kg/d"
442387|NCT00512252|E3|Reported Event|Phase II Dose Treatment (Dose Level 3)|"AMD 3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 3 AMD3100 dose=240 mcg/kg/d (this was the Phase II dose).~The 6 participants that were enrolled in Dose Level 3 in the Phase I portion of the study were carried over to the Phase II analysis. 40 additional patients were enrolled in the Phase II portion of the study using the Dose Level 3 dose."
442388|NCT00512252|E2|Reported Event|Phase I Dose Escalation (Dose Level 2)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 2 AMD3100 dose = 160 mcg/kg/d"
442389|NCT00512252|E1|Reported Event|Phase I Dose Escalation (Dose Level 1)|"AMD3100 SQ on days 0-5~Mitoxantrone on days 1-5~Etoposide on days 1-5~Cytarabine on days 1-5~Dose Level 1 AMD3100 dose = 80 mcg/kg/d"
442390|NCT00512148|B1|Baseline|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
442391|NCT00512148|P1|Participant Flow|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
442392|NCT00512148|O1|Outcome|Enterocystoplasty With the Neo-bladder Augment|Patients were enrolled who required enterocystoplasty (bladder augmentation). Patients in this study were augmented with with the Tengion neo-bladder augment. During this procedure the neo-bladder augment was surgically attached to the patient's existing bladder to enlarge its size.
442393|NCT00512148|O1|Outcome|All Implanted|The number of subjects implanted with the neobladder augment
442394|NCT00512148|E1|Reported Event|Safety Population|Patients who underwent screening procedures and met inclusion/exclusion criteria.
442395|NCT00512096|B1|Baseline|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
442396|NCT00512096|P1|Participant Flow|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
442397|NCT00512096|O1|Outcome|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
442398|NCT00512096|E1|Reported Event|Cisplatin + Ifosfamide + Paclitaxel|Cisplatin 25 mg/m^2 IV Days 1-3; Ifosfamide 1200 mg/m^2 IV Days 1-3; Paclitaxel 175 mg/m^2 IV Day 1
442399|NCT00511914|B3|Baseline|Total|Total of all reporting groups
442400|NCT00511914|B2|Baseline|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442401|NCT00511914|B1|Baseline|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442402|NCT00511914|P2|Participant Flow|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442403|NCT00511914|P1|Participant Flow|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442404|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442405|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442406|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442407|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442408|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442409|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442410|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442411|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442412|NCT00511914|O2|Outcome|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442413|NCT00511914|O1|Outcome|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442414|NCT00511914|E2|Reported Event|cTIV (Elderly)|Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442415|NCT00511914|E1|Reported Event|cTIV (Adults)|Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
442416|NCT00511901|B3|Baseline|Total|Total of all reporting groups
442417|NCT00511901|B2|Baseline|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442418|NCT00511901|B1|Baseline|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442419|NCT00511901|P2|Participant Flow|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442420|NCT00511901|P1|Participant Flow|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442421|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442422|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442423|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442424|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
444536|NCT00506714|B2|Baseline|Group 2|Adults with symptomatic hip osteoarthritis
442425|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442426|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442427|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442428|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442429|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442430|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442431|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442432|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442433|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442434|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442435|NCT00511901|O2|Outcome|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442436|NCT00511901|O1|Outcome|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442437|NCT00511901|E2|Reported Event|Epoetin Alpha & Niferex|40,000 IU (initial dose) epoetin alpha subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442438|NCT00511901|E1|Reported Event|Placebo & Niferex|Placebo (for epoetin alpha) subcutaneous injection weekly for 8 weeks and Niferex 150 mg twice a day for 8 weeks
442439|NCT00511862|B4|Baseline|Total|Total of all reporting groups
442440|NCT00511862|B3|Baseline|Non-Colorectal/Non-neuroendocrine|patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy
442441|NCT00511862|B2|Baseline|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
442442|NCT00511862|B1|Baseline|Colorectal Cancer|colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy
442443|NCT00511862|P3|Participant Flow|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442444|NCT00511862|P2|Participant Flow|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442445|NCT00511862|P1|Participant Flow|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442446|NCT00511862|O1|Outcome|Neuroendocrine Cancer|neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy
442447|NCT00511862|O3|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
442448|NCT00511862|O2|Outcome|Non Colorectal/Non-Neuroendocrine|Patients with metastatic liver disease arising from primary cancers other than colorectal or neuroendocrine cancer who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442449|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442450|NCT00511862|O4|Outcome|All Patients|All patients in colorectal cancer, neuroendocrine cancer and non-colorectal/non-neuroendocrine groups
442451|NCT00511862|O3|Outcome|Non-Colorectal/Non-neuroendocrine|Patients with liver metastatic disease not arising from colorectal cancer or neuroendocrine cancer, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442452|NCT00511862|O2|Outcome|Neuroendocrine Cancer|Neuroendocrine cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442453|NCT00511862|O1|Outcome|Colorectal Cancer|Colorectal cancer patients with liver metastatic disease, refractory to standard of care therapy who received intrahepatic TheraSphere yttrium-90 glass microspheres (target dose 120 Gy) on Day 0
442454|NCT00511862|E1|Reported Event|TheraSphere|total population receiving at least one TheraSphere treatment
442455|NCT00511836|B3|Baseline|Total|Total of all reporting groups
442456|NCT00511836|B2|Baseline|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442457|NCT00511836|B1|Baseline|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442458|NCT00511836|P2|Participant Flow|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442459|NCT00511836|P1|Participant Flow|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442460|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442461|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442462|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442463|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442464|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442465|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442466|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442467|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442468|NCT00511836|O2|Outcome|Placebo|Placebo matching VIVITROL 380 mg - single administration via intramuscular injection on Day 1
442469|NCT00511836|O1|Outcome|VIVITROL 380 mg|VIVITROL 380 mg (naltrexone for extended-release injectable suspension) - single administration via intramuscular (IM) injection on Day 1
442470|NCT00511836|E3|Reported Event|Optional Open-label VIVITROL Period (2 Months)|Following the 28-day, double-blind treatment period, all subjects were offered a chance to receive open-label VIVITROL for an additional 2 months (2 injections, each separated by 1 month). Safety data are described for all subjects in the VIVITROL open-label period, regardless of the treatment received (VIVITROL or placebo) for the first month.
442471|NCT00511836|E2|Reported Event|Placebo (Double-blind Period)|Placebo for VIVITROL 380 mg. Data are described for the initial 28-day double-blind period.
442472|NCT00511836|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|VIVITROL 380 mg (naltrexone for extended-release injectable suspension). Data are described for the initial 28-day double-blind period.
442473|NCT00511810|B3|Baseline|Total|Total of all reporting groups
442474|NCT00511810|B2|Baseline|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
442475|NCT00511810|B1|Baseline|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
442476|NCT00511810|P2|Participant Flow|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
442477|NCT00511810|P1|Participant Flow|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
442478|NCT00511810|O2|Outcome|Baseline CDRS-R: Low Dose Fish Oil|CDRS-R scores were computed for Low Fish Oil groups.
442479|NCT00511810|O1|Outcome|Baseline CDRS-R: High Dose Fish Oil|CDRS-R scores were computed for High Fish Oil groups.
442480|NCT00511810|E2|Reported Event|Low Dose Fish Oil|"Capsule omega-3 fatty acids 2.4g/day (4 capsules/day)~Low Dose Fish Oil : Omega-3 Fatty Acids 2.4g/day in capsule form (4 capsules per day)"
442481|NCT00511810|E1|Reported Event|High Dose Fish Oil|"Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)~High Dose Fish Oil : Liquid omega-3 fatty acid 15 g/day (2 tablespoons/day)"
442482|NCT00511797|B5|Baseline|Total|Total of all reporting groups
442483|NCT00511797|B4|Baseline|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442484|NCT00511797|B3|Baseline|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442485|NCT00511797|B2|Baseline|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442486|NCT00511797|B1|Baseline|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442487|NCT00511797|P4|Participant Flow|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442488|NCT00511797|P3|Participant Flow|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442489|NCT00511797|P2|Participant Flow|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442490|NCT00511797|P1|Participant Flow|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442491|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442492|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442493|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442494|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442495|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442496|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442497|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442498|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442499|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442500|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442501|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442502|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442503|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
444537|NCT00506714|B1|Baseline|Group 1|Healthy adults
442504|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442505|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442506|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442507|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442508|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442509|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442510|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442511|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442512|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442513|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442514|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442515|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442516|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442517|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442518|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442519|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442520|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442521|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442522|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442523|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442524|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442525|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442526|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442527|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442528|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442529|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442530|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442531|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442532|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442533|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442534|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442535|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442536|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442537|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442538|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442539|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442540|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442541|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442542|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442543|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442544|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442545|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442546|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442547|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442548|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442549|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442550|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442551|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442552|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442553|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442554|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442555|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442556|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442557|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442558|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442559|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442560|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442561|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442562|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442563|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442564|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442565|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442566|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442567|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442568|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442569|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442570|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442571|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442572|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442573|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442574|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442575|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442576|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442577|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442578|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442579|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442580|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442581|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442582|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442583|NCT00511797|O4|Outcome|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442584|NCT00511797|O3|Outcome|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442585|NCT00511797|O2|Outcome|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442586|NCT00511797|O1|Outcome|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442587|NCT00511797|E4|Reported Event|Placebo|1 tablet per day placebo for 28 days in each 28-day cycle
442588|NCT00511797|E3|Reported Event|DRSP 3 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442589|NCT00511797|E2|Reported Event|DRSP 2 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 2 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442590|NCT00511797|E1|Reported Event|DRSP 1 mg/EE 20 μg|1 tablet per day Drospirenone (DRSP) 1 mg/Ethinylestradiol (EE) 20 μg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle
442591|NCT00511706|B3|Baseline|Total|Total of all reporting groups
442592|NCT00511706|B2|Baseline|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442593|NCT00511706|B1|Baseline|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442594|NCT00511706|P2|Participant Flow|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442595|NCT00511706|P1|Participant Flow|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442596|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442597|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442598|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442599|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442600|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442601|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442602|NCT00511706|O2|Outcome|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442603|NCT00511706|O1|Outcome|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442604|NCT00511706|E2|Reported Event|Sham and Ranibizumab|Sham injection at Day 1; ranibizumab 500 µg at day -30 and Day 7-14.
442605|NCT00511706|E1|Reported Event|Dexamethasone and Ranibizumab|Intravitreal injection of dexamethasone 700 µg at Day 1; ranibizumab 500 µg at Day -30 and Day 7-14.
442606|NCT00511667|B3|Baseline|Total|Total of all reporting groups
442607|NCT00511667|B2|Baseline|Placebo|All participants receiving any dose of placebo
442608|NCT00511667|B1|Baseline|MK-0941|All participants receiving any dose of MK-0941
442609|NCT00511667|P2|Participant Flow|Placebo|All participants receiving any dose of placebo
442610|NCT00511667|P1|Participant Flow|MK-0941|All participants receiving any dose of MK-0941
442611|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
442612|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
442613|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
442614|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
442615|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
442616|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442617|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442618|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
442619|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
442620|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
442621|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442622|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg Before Each Meal|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442623|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
442624|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
442625|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
442626|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442627|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442628|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
442629|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
442630|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
442631|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442632|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442633|NCT00511667|O5|Outcome|Panel E: MK-0941 60 mg|MK-0941 60 mg before 2 meals each day for 14 days. Sampling began after dosing on Day 13.
442634|NCT00511667|O4|Outcome|Panel D: MK-0941 40 mg Day 13|MK-0941 40 mg before each meal for 13 days. Sampling began after dosing on Day 13. These participants are different from those in Panel C.
442635|NCT00511667|O3|Outcome|Panel C: MK-0941 40 mg Day 7|MK-0941 40 mg before each meal for 7 days. Sampling began after dosing on Day 7. These participants are different from those in Panel D.
442636|NCT00511667|O2|Outcome|Panel B: MK-0941 20 mg|MK-0941 20 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442637|NCT00511667|O1|Outcome|Panel A: MK-0941 10 mg|MK-0941 10 mg before each meal for 5 days. Sampling began after dosing on Day 5.
442638|NCT00511667|O2|Outcome|Placebo|All participants receiving any dose of placebo
442639|NCT00511667|O1|Outcome|MK-0941|All participants receiving any dose of MK-0941
442640|NCT00511667|E2|Reported Event|Placebo|All participants receiving any dose of placebo
442641|NCT00511667|E1|Reported Event|MK-0941|All participants receiving any dose of MK-0941
442642|NCT00511472|B3|Baseline|Total|Total of all reporting groups
442643|NCT00511472|B2|Baseline|Placebo|Participants receiving placebo while on basal insulin.
442644|NCT00511472|B1|Baseline|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
442645|NCT00511472|P2|Participant Flow|Placebo|Participants receiving placebo while on basal insulin.
442646|NCT00511472|P1|Participant Flow|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
442647|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin
442648|NCT00511472|O1|Outcome|MK-0941|Participants receiving individualized doses of MK-0941 while on basal insulin
442649|NCT00511472|O3|Outcome|Placebo|Participants receiving placebo while on basal insulin.
442650|NCT00511472|O2|Outcome|MK-0941 (Titration Group 2)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
442651|NCT00511472|O1|Outcome|MK-0941 (Titration Group 1)|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
442652|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
442653|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #2 while on basal insulin.
442654|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
442655|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 according to Titration Scheme #1 while on basal insulin.
442656|NCT00511472|O2|Outcome|Placebo|Participants receiving placebo while on basal insulin.
442657|NCT00511472|O1|Outcome|MK-0941|Participants receiving multiple daily before each meal (q.a.c.) administrations of MK-0941 while on basal insulin.
442658|NCT00511472|E4|Reported Event|Placebo Titration 2|Participants receiving placebo while on basal insulin.
442659|NCT00511472|E3|Reported Event|Placebo Titration 1|Participants receiving placebo while on basal insulin.
442660|NCT00511472|E2|Reported Event|MK-0941 Titration 2|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 2 while on basal insulin.
442661|NCT00511472|E1|Reported Event|MK-0941 Titration 1|Participants receiving multiple daily q.a.c. administrations of MK-0941 according to Titration Scheme 1 while on basal insulin.
442662|NCT00511433|B3|Baseline|Total|Total of all reporting groups
442663|NCT00511433|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442664|NCT00511433|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442665|NCT00511433|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442666|NCT00511433|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442667|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442668|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442669|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442900|NCT00511108|P3|Participant Flow|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
451551|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
442670|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442671|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442672|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442673|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442674|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442675|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442676|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442677|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442678|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442679|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442680|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442681|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442682|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442683|NCT00511433|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
442684|NCT00511433|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.~n=number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
442685|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442686|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442687|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442688|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442689|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442690|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442691|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
444538|NCT00506714|P2|Participant Flow|Group 2|Adults with symptomatic hip osteoarthritis
442692|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442693|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442694|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442695|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442696|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442697|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442698|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442699|NCT00511433|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442700|NCT00511433|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442701|NCT00511433|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442702|NCT00511433|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day menstrual cycles.
442703|NCT00511355|B3|Baseline|Total|Total of all reporting groups
442704|NCT00511355|B2|Baseline|LNG-EE|"All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 6 consecutive 28-day cycles"
442705|NCT00511355|B1|Baseline|NOMAC-E2|All-participants-treated group. Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles
442706|NCT00511355|P2|Participant Flow|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442707|NCT00511355|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442708|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442709|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442710|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442711|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442712|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
442713|NCT00511355|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
443237|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
442714|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442715|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442716|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442717|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442718|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442719|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442720|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442721|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442722|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442723|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442724|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442725|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442726|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442727|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442728|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442729|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442730|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442731|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442732|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442733|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442734|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442735|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
443238|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
442736|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442737|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442738|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442739|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442740|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442741|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442742|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442743|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442744|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442745|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442746|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442747|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442748|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442749|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442750|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442751|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442752|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442753|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442754|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442755|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442756|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442757|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
444539|NCT00506714|P1|Participant Flow|Group 1|Healthy adults
442758|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442759|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442760|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442761|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442762|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442763|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442764|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442765|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442766|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442767|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442768|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442769|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442770|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442771|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442772|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442773|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442774|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442775|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442776|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442777|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442778|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442779|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
444713|NCT00506064|P1|Participant Flow|Melatonin|0.15 mg/kg capsules by mouth daily
442780|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442781|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442782|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442783|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442784|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442785|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442786|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442787|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442788|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442789|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442790|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442791|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442792|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442793|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442794|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442795|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442796|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442797|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442798|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442799|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442800|NCT00511355|O2|Outcome|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442801|NCT00511355|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
444714|NCT00506064|O2|Outcome|Placebo|Starch capsules by mouth daily
442802|NCT00511355|E2|Reported Event|LNG-EE|"Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg~ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28 placebo tablets) for 6 consecutive 28-day cycles."
442803|NCT00511355|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 6 consecutive 28-day cycles.
442804|NCT00511342|B3|Baseline|Total|Total of all reporting groups
442805|NCT00511342|B2|Baseline|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442806|NCT00511342|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442807|NCT00511342|P2|Participant Flow|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442808|NCT00511342|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442809|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442810|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442811|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442812|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442813|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442814|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442815|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442816|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442817|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442818|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442819|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442820|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442821|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442822|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442823|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442901|NCT00511108|P2|Participant Flow|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442824|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442825|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442826|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442827|NCT00511342|O2|Outcome|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442828|NCT00511342|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442829|NCT00511342|E2|Reported Event|LNG-EE|Monophasic combined oral contraceptive (COC) tablets containing 0.150 mg levonorgestrel (LNG) and 0.030 mg ethinylestradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442830|NCT00511342|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 26 consecutive 28-day cycles (2 years).
442831|NCT00511238|B3|Baseline|Total|Total of all reporting groups
442832|NCT00511238|B2|Baseline|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
442833|NCT00511238|B1|Baseline|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle
442834|NCT00511238|P2|Participant Flow|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
442835|NCT00511238|P1|Participant Flow|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycles
442836|NCT00511238|O2|Outcome|Carfilzomib (A1) - Response-evaluable Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population(the primary analysis population) was defined as all patients who~had measurable disease at Baseline by either M-protein (serum and/or urine) or by quantitative serum Ig for certain patients with IgA myeloma~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or patients who discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib—irrespective of availability of baseline and post-baseline assessment"
442837|NCT00511238|O1|Outcome|Carfilzomib (A1) - Safety Population|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Safety population: The safety population was used for the analysis of safety data in this study. The safety population consists of all enrolled patients who received at least 1 dose of carfilzomib. However, for some safety analyses, at least 1 laboratory, neurological, electrocardiogram, or vital sign measurement obtained subsequent to at least 1 dose of carfilzomib was required for inclusion in the analysis of a safety specific parameter. To assess change from baseline, a baseline measurement was also required."
442838|NCT00511238|O1|Outcome|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
442839|NCT00511238|O1|Outcome|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
442840|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
442841|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle.~Assesed by principal investigator."
442842|NCT00511238|O2|Outcome|Carfilzomib (A1) for (CBR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with CBR.
442843|NCT00511238|O1|Outcome|Carfilzomib (A1) for (ORR)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles. For subjects with ORR.
442844|NCT00511238|O1|Outcome|Carfilzomib (A0) for (ORR)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
444715|NCT00506064|O1|Outcome|Melatonin|0.15 mg/kg capsules by mouth daily
442845|NCT00511238|O1|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16. If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Assessed by Independent Review Committee"
442846|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of 28 day cycle.~Assessed by principal investigator."
442847|NCT00511238|O2|Outcome|Carfilzomib (A1)|"In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.~Response-Evaluable Population:~had measurable disease at Baseline~received at least 1 dose of carfilzomib~underwent baseline disease response assessments and at least 1 post-baseline disease assessment, or discontinued protocol treatment before Cycle 2 Day 1 due to an AE that was considered to be possibly or probably related to carfilzomib"
442848|NCT00511238|O1|Outcome|Carfilzomib (A0)|"Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle~Response-evaluable Population: Enrolled patients who completed at least 1 cycle of carfilzomib and who underwent disease assessments at Screening, Cycle 1 Day 15, and Cycle 2 Day 24. This analysis set also included patients who discontinued treatment during this time due to an AE that was considered probably related to carfilzomib."
442849|NCT00511238|E2|Reported Event|Carfilzomib (A1)|In Cycle 1, subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16.If all doses are administered and well-tolerated over the 28-day cycle, beginning with Cycle 2 the dose will escalate to 27 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 for all subsequent cycles.
442850|NCT00511238|E1|Reported Event|Carfilzomib (A0)|Subjects will receive carfilzomib 20 mg/m2 intravenously on Days 1, 2, 8, 9, 15, and 16 of a 28 day cycle
442851|NCT00511199|B3|Baseline|Total|Total of all reporting groups
442852|NCT00511199|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442853|NCT00511199|B1|Baseline|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442854|NCT00511199|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442855|NCT00511199|P1|Participant Flow|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442856|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442857|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442858|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442859|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442860|NCT00511199|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
442861|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
442862|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442863|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442864|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442865|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
443239|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
442866|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442867|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442868|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442869|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442870|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442871|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442872|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442873|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442874|NCT00511199|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442875|NCT00511199|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442876|NCT00511199|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
442877|NCT00511199|E1|Reported Event|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual~period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year)."
442878|NCT00511173|B1|Baseline|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
442879|NCT00511173|P1|Participant Flow|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
442880|NCT00511173|O2|Outcome|Pharmacist Dosing|Warfarin dose based on clinician dosing
442881|NCT00511173|O1|Outcome|Algorithm Dosing|Warfarin dose based on algorithm by Sconce, et al.
442882|NCT00511173|E1|Reported Event|Pharmacist Dosing|Warfarin dose based on pharmacist dosing
442883|NCT00511134|B3|Baseline|Total|Total of all reporting groups
442884|NCT00511134|B2|Baseline|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
442885|NCT00511134|B1|Baseline|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
442886|NCT00511134|P2|Participant Flow|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
442887|NCT00511134|P1|Participant Flow|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
442888|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
442889|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
442890|NCT00511134|O2|Outcome|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
442891|NCT00511134|O1|Outcome|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
442892|NCT00511134|E2|Reported Event|Zyban + Placebo|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and placebo pill (1 pill per day x 6 weeks)
442893|NCT00511134|E1|Reported Event|Zyban + Lunesta|Bupropion SR (Zyban; 150 mg qd x 7 days, then 150 mg bid x 6 weeks) and Eszopiclone (Lunesta; 3 mg qd x 6 weeks)
442894|NCT00511108|B5|Baseline|Total|Total of all reporting groups
442895|NCT00511108|B4|Baseline|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442896|NCT00511108|B3|Baseline|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
442897|NCT00511108|B2|Baseline|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442898|NCT00511108|B1|Baseline|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442899|NCT00511108|P4|Participant Flow|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442902|NCT00511108|P1|Participant Flow|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442903|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442904|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
442905|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442906|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442907|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442908|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
442909|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442910|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442911|NCT00511108|O4|Outcome|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442912|NCT00511108|O3|Outcome|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
442913|NCT00511108|O2|Outcome|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442914|NCT00511108|O1|Outcome|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442915|NCT00511108|E4|Reported Event|Placebo|Includes patients receiving once-daily administration of matching placebo to sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442916|NCT00511108|E3|Reported Event|Sitagliptin 100 mg + Pioglitazone 30 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and pioglitazone 30 mg.
442917|NCT00511108|E2|Reported Event|Pioglitazone 30 mg|Includes patients receiving once-daily administration of pioglitazone 30 mg and matching placebo to sitagliptin 100 mg.
442918|NCT00511108|E1|Reported Event|Sitagliptin 100 mg|Includes patients receiving once-daily administration of sitagliptin 100 mg and matching placebo to pioglitazone 30 mg.
442919|NCT00511004|B4|Baseline|Total|Total of all reporting groups
442920|NCT00511004|B3|Baseline|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442921|NCT00511004|B2|Baseline|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442922|NCT00511004|B1|Baseline|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442923|NCT00511004|P3|Participant Flow|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442924|NCT00511004|P2|Participant Flow|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442925|NCT00511004|P1|Participant Flow|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442926|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442927|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442928|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442929|NCT00511004|O3|Outcome|Diethylcarbamazine/Albendazole-HD2|"High dose of DEC (300mg) and albendazole (800mg) twice yearly (every 6 months)~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
442930|NCT00511004|O2|Outcome|Diethylcarbamazine/Albendazole- HD1|"High dose of DEC (300mg) and albendazole (800mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
442931|NCT00511004|O1|Outcome|Diethylcarbamazine/Albendazole -STD|"Standard therapy of diethylcarbamazine (DEC) (300mg) and albendazole (400mg) yearly~Albendazole: Comparing 400 mg to 800 mg dose~Diethylcarbamazine: Providing diethylcarbamazine more frequently in combination with albendazole"
442932|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442933|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442934|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442935|NCT00511004|O3|Outcome|High Dose Semiannual DEC/ALB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442936|NCT00511004|O2|Outcome|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442937|NCT00511004|O1|Outcome|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442938|NCT00511004|E3|Reported Event|High Dose Semiannual DEC/AC=LB|Group randomized to twice-yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442939|NCT00511004|E2|Reported Event|High Dose Annual DEC/ALB|Group randomized to yearly high dose albendazole that consists of Annual diethylcarbamazine (300 mg) and albendazole (800mg)
442940|NCT00511004|E1|Reported Event|Standard Therapy Annual DEC/ALB|Group randomized to standard therapy that consists of Annual diethylcarbamazine (300 mg) and albendazole (400mg)
442941|NCT00510952|B3|Baseline|Total|Total of all reporting groups
442942|NCT00510952|B2|Baseline|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442943|NCT00510952|B1|Baseline|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442944|NCT00510952|P2|Participant Flow|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442945|NCT00510952|P1|Participant Flow|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442946|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442947|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442948|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442949|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442950|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442951|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442952|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442953|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442954|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442955|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442956|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442957|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442958|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442959|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442960|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442961|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442962|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442963|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442964|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442965|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442966|NCT00510952|O2|Outcome|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442967|NCT00510952|O1|Outcome|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442968|NCT00510952|E2|Reported Event|Glargine|Insulin glargine: Patient adjusted dose, once daily (QD), injected subcutaneous (SC) x 24 weeks
442969|NCT00510952|E1|Reported Event|Lispro|Insulin Lispro protamine suspension: Patient adjusted dose, once daily (QD) or twice daily (BID), injected subcutaneous (SC) x 24 weeks
442970|NCT00510887|B1|Baseline|VR-FND|"Bortezomib (VELCADER) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442971|NCT00510887|P1|Participant Flow|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442972|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442989|NCT00510874|P5|Participant Flow|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443240|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
442973|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442974|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442975|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442976|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442977|NCT00510887|O1|Outcome|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442978|NCT00510887|E1|Reported Event|VR-FND|"Bortezomib (VELCADE) 1.6 mg/m2 IV days 1 and 8 Rituximab 375 mg/m2 IV on day 1 Fludarabine 25 mg/m2 IV on days 1,2,3 Mitoxantrone 10 mg/m2 IV on day 2 Dexamethasone 20 mg orally on days 1,2,3,4,5 On day 1 the sequence of drug administration will be Bortezomib followed by Fludarabine followed by Rituximab.~Each cycle will be repeated every 28 days for 8 cycles maximum.~Bortezomib: Bortezomib 1.6 mg/m2 on days 1 and 8 of each 28-day cycle~Rituximab: Rituximab 375 mg/m2 IV on day 1~Fludarabine: Fludarabine 25 mg/m2 IV on days 1,2,3~Mitoxantrone: Mitoxantrone 10 mg/m2 IV on day 2~Dexamethasone: Dexamethasone 20 mg orally on days 1,2,3,4,5"
442979|NCT00510874|B8|Baseline|Total|Total of all reporting groups
442980|NCT00510874|B7|Baseline|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442981|NCT00510874|B6|Baseline|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442982|NCT00510874|B5|Baseline|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442983|NCT00510874|B4|Baseline|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442984|NCT00510874|B3|Baseline|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442985|NCT00510874|B2|Baseline|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442986|NCT00510874|B1|Baseline|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442987|NCT00510874|P7|Participant Flow|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442988|NCT00510874|P6|Participant Flow|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
451552|NCT00485472|O2|Outcome|Placebo|Placebo
442990|NCT00510874|P4|Participant Flow|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442991|NCT00510874|P3|Participant Flow|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442992|NCT00510874|P2|Participant Flow|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442993|NCT00510874|P1|Participant Flow|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442994|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442995|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442996|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442997|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442998|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
442999|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443000|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443001|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443002|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443003|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443004|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443005|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443006|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443007|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443008|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443009|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443010|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443011|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443012|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443013|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443014|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443015|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443016|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443017|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443018|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443019|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443020|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443021|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443022|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443023|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443024|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443025|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443026|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443027|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443028|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443029|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443030|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443031|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443032|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443033|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443034|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443035|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443036|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443037|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443038|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443039|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443040|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443041|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443042|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443043|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443044|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443045|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443046|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443047|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443048|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443049|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443050|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443051|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443052|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443053|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443054|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443055|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443056|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443057|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443058|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443059|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443060|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443061|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443062|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443063|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443064|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443065|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443066|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443067|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443068|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443069|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443070|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443071|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443072|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443073|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443074|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443075|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443076|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443077|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443078|NCT00510874|O7|Outcome|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443079|NCT00510874|O6|Outcome|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443080|NCT00510874|O5|Outcome|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443081|NCT00510874|O4|Outcome|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443082|NCT00510874|O3|Outcome|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443083|NCT00510874|O2|Outcome|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443084|NCT00510874|O1|Outcome|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443085|NCT00510874|E7|Reported Event|Pumarix Formulation 5 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 5 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443086|NCT00510874|E6|Reported Event|Pumarix Formulation 4 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 4 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443087|NCT00510874|E5|Reported Event|Pandemrix Formulation B Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation B of Pandemrix ™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443088|NCT00510874|E4|Reported Event|Pandemrix Formulation A Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation A of Pandemrix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443089|NCT00510874|E3|Reported Event|Pumarix Formulation 3 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 3 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443090|NCT00510874|E2|Reported Event|Pumarix Formulation 2 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 2 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443091|NCT00510874|E1|Reported Event|Pumarix Formulation 1 Group|Healthy subjects aged between 18 and 64 years at the time of vaccination received two doses of formulation 1 of Pumarix™ vaccine at Day 0 and Day 21. The vaccine was administered intramuscularly in the deltoid region of the arm (non-dominant arm for the first injection and dominant arm for the second one).
443092|NCT00510835|B4|Baseline|Total|Total of all reporting groups
443093|NCT00510835|B3|Baseline|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
443094|NCT00510835|B2|Baseline|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
443095|NCT00510835|B1|Baseline|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
443096|NCT00510835|P3|Participant Flow|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
443097|NCT00510835|P2|Participant Flow|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
443098|NCT00510835|P1|Participant Flow|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
443099|NCT00510835|O3|Outcome|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
443100|NCT00510835|O2|Outcome|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
443101|NCT00510835|O1|Outcome|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
443102|NCT00510835|E3|Reported Event|Usual Care|"Usual Care - The attending physicians will treat the subjects according to their standard treatment plan and without any influence from the study team. A member of the study team will simply observe and record what happens.~Usual Care (UC): Attending physicians will provide routine care to subjects. Study measurements and treatments will be based on the physicians'/sites' standard practices."
443103|NCT00510835|E2|Reported Event|Protocolized Standard Care (PSC)|"Protocolized Standard Care (PSC)- The study team will monitor the subjects' blood pressure and blood oxygen level with routine equipment. The study team will use this information to give fluid and heart medications in a structured fashion. CVCs will only be used when standard IVs are unable to give the proper amount of fluids and medicines. Blood transfusions will be given according to currently recommended guidelines.~Protocolized Standard Care (PSC): Routine equipment will be used to monitor subjects' blood pressure and oxygen levels. Early structured treatment is based on the subjects' systolic blood pressure and the study doctors' judgment of fluid status and perfusion status."
443104|NCT00510835|E1|Reported Event|Early Goal Directed Therapy (EGDT)|"Early Goal Directed Therapy (EGDT) - The study team will insert a central venous catheter (CVC) for continuous monitoring of the subjects' central venous pressure (CVP) and central venous oxygen saturation (Scv02). The study team will use this information to give fluid, blood, and heart medications in a structured fashion. The CVC is FDA approved and routinely used in hospitals.~Early Goal Directed Therapy (EGDT): Subjects will have a CVC inserted for continuous monitoring of their CVP and Scv02. Early structured treatment will be provided based on subjects' CVP, mean arterial pressure (MAP) and Scv02 measurements."
443105|NCT00510809|B4|Baseline|Total|Total of all reporting groups
443106|NCT00510809|B3|Baseline|Policosanol|20 mg daily, open label
443107|NCT00510809|B2|Baseline|Statin and Placebo|20mg daily, double-blind
443108|NCT00510809|B1|Baseline|Statin and Policosanol|20mg daily, double-blind
443109|NCT00510809|P3|Participant Flow|Policosanol|20 mg daily, open label
443110|NCT00510809|P2|Participant Flow|Statin and Placebo|20mg daily, double-blind
443111|NCT00510809|P1|Participant Flow|Statin and Policosanol|20mg daily, double-blind
443112|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
443113|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
443114|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
443115|NCT00510809|O3|Outcome|Policosanol|20 mg daily, open label
443116|NCT00510809|O2|Outcome|Statin and Placebo|20mg daily, double-blind
443117|NCT00510809|O1|Outcome|Statin and Policosanol|20mg daily, double-blind
443118|NCT00510809|E3|Reported Event|Policosanol|20 mg daily, open label
443119|NCT00510809|E2|Reported Event|Statin and Placebo|20mg daily, double-blind
443120|NCT00510809|E1|Reported Event|Statin and Policosanol|20mg daily, double-blind
443121|NCT00510783|B3|Baseline|Total|Total of all reporting groups
443122|NCT00510783|B2|Baseline|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
443123|NCT00510783|B1|Baseline|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
443124|NCT00510783|P2|Participant Flow|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
443125|NCT00510783|P1|Participant Flow|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
443126|NCT00510783|O2|Outcome|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
443127|NCT00510783|O1|Outcome|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
443128|NCT00510783|E2|Reported Event|Levetiracetam|Patients in the intervention arm will receive IV Keppra (1 gram of Keppra added to 100 mL diluent infused over 15 minutes).
443129|NCT00510783|E1|Reported Event|Phenytoin/Fosphenytoin|Patients in the control arm will receive either IV Dilantin (1 gram of IV phenytoin infused at 25 mg/min or slower depending on vitals) or IV Fosphenytoin (1 gram of IV Fosphenytoin infused at 15 mg/min or slower depending on vitals).
443130|NCT00510744|B1|Baseline|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
443131|NCT00510744|P1|Participant Flow|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
443132|NCT00510744|O1|Outcome|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~The ability of pancreatic enzyme supplement: 4 caps with meals, 2 with snacks to improve fat absorption"
443133|NCT00510744|E1|Reported Event|Pancreatic Enzyme Supplementation|"3 month supplementation in those gastric bypass patients shown to have a fat absorption less than 80%~pancreatic enzyme supplement: 4 caps with meals, 2 with snacks"
443134|NCT00510692|B3|Baseline|Total|Total of all reporting groups
443135|NCT00510692|B2|Baseline|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443136|NCT00510692|B1|Baseline|2g/Day EPA|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443137|NCT00510692|P2|Participant Flow|Placebo|Medium chain triglycerides 2 g per day for six months.
443138|NCT00510692|P1|Participant Flow|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
443139|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443169|NCT00510510|E2|Reported Event|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443170|NCT00510510|E1|Reported Event|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
443241|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443140|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443141|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443142|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443143|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443144|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443145|NCT00510692|O2|Outcome|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443146|NCT00510692|O1|Outcome|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443147|NCT00510692|O2|Outcome|Placebo|Medium chain triglycerides 2g per day for six months
443148|NCT00510692|O1|Outcome|2g/Day Eicosapentaenoic Acid (EPA)|Eicosapentaenoic Acid (EPA) 2g per day for six months
443149|NCT00510692|E2|Reported Event|Placebo|"Medium chain triglycerides 2 capsules twice daily for six months.~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443150|NCT00510692|E1|Reported Event|2g/Day Eicosapentanoic Acid (EPA)|"Eicosapentanoic Acid (EPA): 2 x 500mg EPA capsules twice daily for 6 months~Endoscopy: With video and photographs at baseline and month 6.~Biopsies taken: 9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy)."
443151|NCT00510653|B1|Baseline|Imatinib Mesylate|600 mg/day orally for 6 Weeks
443152|NCT00510653|P1|Participant Flow|Imatinib Mesylate|600 mg/day orally for 6 Weeks
443153|NCT00510653|O1|Outcome|Imatinib Mesylate|600 mg/day orally for 6 Weeks
443154|NCT00510653|E1|Reported Event|Imatinib Mesylate|600 mg/day orally for 6 Weeks
443155|NCT00510510|B4|Baseline|Total|Total of all reporting groups
443156|NCT00510510|B3|Baseline|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443157|NCT00510510|B2|Baseline|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443158|NCT00510510|B1|Baseline|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
443159|NCT00510510|P3|Participant Flow|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443160|NCT00510510|P2|Participant Flow|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443161|NCT00510510|P1|Participant Flow|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443162|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443163|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443164|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
443165|NCT00510510|O3|Outcome|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443166|NCT00510510|O2|Outcome|NVA237 200 µg|NVA237 200 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443167|NCT00510510|O1|Outcome|NVA237 100 µg|NVA237 100 µg as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days..
443168|NCT00510510|E3|Reported Event|Placebo|Matching placebo to NVA237 as a single dose dry powder inhaler (SDDPI), once a day in the morning for 28 days.
443235|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443171|NCT00510497|B1|Baseline|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
443172|NCT00510497|P1|Participant Flow|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
443173|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
443174|NCT00510497|O1|Outcome|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
443175|NCT00510497|E1|Reported Event|Autologous HIV-1 ApB DC Vaccine|"Subjects who will receive ApB Dendritic cell vaccine (does not include one enrolled participant who received no study treatment)~Autologous HIV-1 ApB DC Vaccine: Autologous dendritic cells pulsed with autologous, inactivated HIV-1 infected, apoptotic cells given subcutaneously 3 times every other week plus a booster dose 2 weeks after start of treatment interruption"
443176|NCT00510484|B3|Baseline|Total|Total of all reporting groups
443177|NCT00510484|B2|Baseline|Pancrelipase/Placebo|
443178|NCT00510484|B1|Baseline|Placebo/Pancrelipase|
443179|NCT00510484|P2|Participant Flow|Pancrelipase/Placebo|
443180|NCT00510484|P1|Participant Flow|Placebo/Pancrelipase|
443181|NCT00510484|O2|Outcome|Placebo|
443182|NCT00510484|O1|Outcome|Pancrelipase|
443183|NCT00510484|O2|Outcome|Placebo|
443184|NCT00510484|O1|Outcome|Pancrelipase|
443185|NCT00510484|O2|Outcome|Placebo|
443186|NCT00510484|O1|Outcome|Pancrelipase|
443187|NCT00510484|O2|Outcome|Placebo|
443188|NCT00510484|O1|Outcome|Pancrelipase|
443189|NCT00510484|O2|Outcome|Placebo|
443190|NCT00510484|O1|Outcome|Pancrelipase|
443191|NCT00510484|O2|Outcome|Placebo|
443192|NCT00510484|O1|Outcome|Pancrelipase|
443193|NCT00510484|O2|Outcome|Placebo|
443194|NCT00510484|O1|Outcome|Pancrelipase|
443195|NCT00510484|O2|Outcome|Placebo|
443196|NCT00510484|O1|Outcome|Pancrelipase|
443197|NCT00510484|E2|Reported Event|Placebo|
443198|NCT00510484|E1|Reported Event|Pancrelipase|
443199|NCT00510289|B1|Baseline|All Patients|All patients who signed consent
443200|NCT00510289|P1|Participant Flow|All Patients|All patients who signed consent
443201|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
443202|NCT00510289|O1|Outcome|Evaluable Patients|Patients who received at least one cycle of study drug and underwent bone marrow assessments
443203|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
443204|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
443205|NCT00510289|O1|Outcome|Evaluable Subjects|Patients who received at least one cycle of study drug and underwent bone marrow assessments
443206|NCT00510289|E1|Reported Event|All Patients|SAEs are listed for all patients who took at least one dose of study drug. Due to early study closure and patient withdrawals, Other AEs are listed for 9 patients only.
443207|NCT00510276|B3|Baseline|Total|Total of all reporting groups
443208|NCT00510276|B2|Baseline|Placebo|twice a day for 12 weeks
443209|NCT00510276|B1|Baseline|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443210|NCT00510276|P2|Participant Flow|Placebo|twice a day for 12 weeks
443211|NCT00510276|P1|Participant Flow|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443212|NCT00510276|O4|Outcome|Placebo, Non-Smokers|
443213|NCT00510276|O3|Outcome|Placebo, Smokers|
443214|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-Smokers|
443215|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
443216|NCT00510276|O4|Outcome|Placebo Non-smokers|
443217|NCT00510276|O3|Outcome|Placebo, Smokers|
443218|NCT00510276|O2|Outcome|Atomoxetine 20 - 50 mg BID, Non-smokers|
443219|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID, Smokers|
443220|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443221|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443222|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443223|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443224|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443225|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443226|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443227|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443228|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443229|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443230|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443231|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443232|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443233|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443234|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443243|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443244|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443245|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443246|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443247|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443248|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443249|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443250|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443251|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443252|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443253|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443254|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443255|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443256|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443257|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443258|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443259|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443260|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443261|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443262|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443263|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443264|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443265|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443266|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443267|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443268|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443269|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443270|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443271|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443272|NCT00510276|O1|Outcome|Atomoxetine 20 - 50 mg BID and Placebo|
443273|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443274|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443275|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443276|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443277|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443278|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443279|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443280|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443281|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443282|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443283|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443284|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443285|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443286|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443287|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443288|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443289|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443290|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443291|NCT00510276|O2|Outcome|Placebo|twice a day for 12 weeks
443292|NCT00510276|O1|Outcome|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443293|NCT00510276|E2|Reported Event|Placebo|twice a day for 12 weeks
443294|NCT00510276|E1|Reported Event|Atomoxetine|20-50 mg twice a day for 12 weeks, then up to an additional 12 weeks
443295|NCT00510224|B1|Baseline|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443296|NCT00510224|P1|Participant Flow|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443297|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443298|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443299|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443300|NCT00510224|O1|Outcome|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443301|NCT00510224|E1|Reported Event|Octreotide Acetate|Octreotide acetate 30mg intramuscular every 28 days
443302|NCT00510146|B3|Baseline|Total|Total of all reporting groups
443303|NCT00510146|B2|Baseline|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443304|NCT00510146|B1|Baseline|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443305|NCT00510146|P2|Participant Flow|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443413|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443306|NCT00510146|P1|Participant Flow|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443307|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443308|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443309|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443310|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443311|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443312|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443313|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443314|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443315|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443316|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443317|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443318|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443414|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443676|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
443319|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443320|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443321|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443322|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443323|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443324|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443325|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443326|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443327|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443328|NCT00510146|O1|Outcome|Olanzapine (Open-label Treatment Period)|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Week 6. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Week 7. Those on higher doses will be reduced between Week 6 and 7 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at Week 7; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at Week 7). Dose increases beyond Week 7 are permitted and at the investigator's discretion.
443329|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443330|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443331|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443332|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443333|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443334|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443335|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443336|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443337|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443338|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443339|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443340|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443341|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443342|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443343|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443344|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443345|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443346|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443347|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443348|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443349|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443350|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443351|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443352|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443353|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443354|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443355|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443356|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443357|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443358|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443359|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443415|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443360|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443361|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443362|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443363|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443364|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443365|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443366|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443367|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443368|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443369|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443370|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443371|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443372|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443373|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443374|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443375|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443376|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443377|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443378|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443379|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443380|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443381|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443382|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443383|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443416|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443384|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443385|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443386|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443387|NCT00510146|O2|Outcome|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443388|NCT00510146|O1|Outcome|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg which is increased to 10 mg per day no later than 3-7 days after randomization (Baseline). Subsequent dose increases above 10 mg (up to a maximum of 20 mg per day) are permitted in 5 mg per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg requires study discontinuation.
443389|NCT00510146|E3|Reported Event|Olanzapine (Open Label Treatment Period|During open-label treatment, participants randomized to placebo in double-blind period will receive olanzapine 5 mg starting at Visit 9. Participants randomized to olanzapine must be at a 5 mg olanzapine dose at Visit 10. Those on higher doses will be reduced between Visit 9 and 10 (10 mg reduced to 5 mg; 15 mg reduced to 10 mg and then to 5 mg at visit 10; 20 mg reduced to 15 mg and then 10 mg to dosing at 5 mg at visit 10). Dose increases beyond visit 10 are permitted and at the investigator's discretion.
443390|NCT00510146|E2|Reported Event|Placebo|Matching placebo administered once daily, by mouth during double-blind treatment.
443391|NCT00510146|E1|Reported Event|Olanzapine|During double-blind treatment, participants receive olanzapine at a dose of 5 mg. which is increased to 10 mg. per day no later than 3-7 days after Visit 2. Subsequent dose increases above 10 mg. (up to a maximum of 20 mg per day) are permitted in 5 mg. per day increments, based upon tolerability and symptoms. Dosing may be decreased by any number of decrements, however dosing below 5 mg. requires study discontinuation.
443392|NCT00510068|B3|Baseline|Total|Total of all reporting groups
443393|NCT00510068|B2|Baseline|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443394|NCT00510068|B1|Baseline|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443395|NCT00510068|P2|Participant Flow|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443396|NCT00510068|P1|Participant Flow|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443397|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443398|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443399|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443400|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443401|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443402|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443403|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443404|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443405|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443406|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443407|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443408|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443409|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443410|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443411|NCT00510068|O2|Outcome|Everolimus 5 mg/Day|Participants received 5 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443412|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443477|NCT00509899|B9|Baseline|Total|Total of all reporting groups
451553|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
443417|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443418|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443419|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443420|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443421|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443422|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443423|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443424|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443425|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443426|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443427|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443428|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443429|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443430|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443431|NCT00510068|O2|Outcome|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443432|NCT00510068|O1|Outcome|Everolimus 10 mg/Day|Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443433|NCT00510068|E3|Reported Event|Open Label - Everolimus 10mg|Afinitor OL (for data collected in the open-label period of the study): The open-label set included only patients who received at least one dose of open-label everolimus 10 mg and had at least one safety assessment during the open-label period of the study.
443434|NCT00510068|E2|Reported Event|Placebo|Participants received matching placebo to everolimus daily plus best supportive care. Patients received their first dose of matching placebo at Visit 2 (Cycle 1 Day 1).
443435|NCT00510068|E1|Reported Event|Everolimus 10mg/Day|Afinitor DB: Participants received 10 mg per day of everolimus plus best supportive care. Patients received their first dose of everolimus at Visit 2 (Cycle 1 Day 1).
443436|NCT00509925|B1|Baseline|Entire Trial Population|The entire trial population includes groups randomised to receive either insulin detemir or insulin NPH as their first treatment.
443437|NCT00509925|P2|Participant Flow|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443438|NCT00509925|P1|Participant Flow|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443439|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443440|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443441|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443442|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443443|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443444|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443445|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443446|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443447|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443448|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443449|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443450|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443451|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443452|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443453|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443454|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443455|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443456|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443457|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443458|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443459|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443460|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443461|NCT00509925|O2|Outcome|Insulin NPH First, Then Insulin Detemir|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443462|NCT00509925|O1|Outcome|Insulin Detemir First, Then Insulin NPH|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 1) followed by switch to insulin NPH + insulin aspart (dose adjusted individually) once or twice daily for 16 weeks (treatment period 2)
443463|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443464|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443465|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443466|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443467|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443468|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443469|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443470|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443471|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443472|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443473|NCT00509925|O2|Outcome|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443474|NCT00509925|O1|Outcome|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443475|NCT00509925|E2|Reported Event|Insulin NPH|Insulin NPH + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443476|NCT00509925|E1|Reported Event|Insulin Detemir|Insulin detemir + insulin aspart (dose adjusted individually) once or twice daily in either the 1st or 2nd intervention period
443478|NCT00509899|B8|Baseline|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443479|NCT00509899|B7|Baseline|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443480|NCT00509899|B6|Baseline|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443481|NCT00509899|B5|Baseline|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
443482|NCT00509899|B4|Baseline|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443483|NCT00509899|B3|Baseline|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443484|NCT00509899|B2|Baseline|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443485|NCT00509899|B1|Baseline|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443486|NCT00509899|P8|Participant Flow|200 mg qd|Participants received an initial dose of Ruxolitinib 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443487|NCT00509899|P7|Participant Flow|100 mg qd|Participants received an initial dose of Ruxolitinib 100 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443488|NCT00509899|P6|Participant Flow|50 mg qd|Participants received an initial dose of Ruxolitinib 50 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443489|NCT00509899|P5|Participant Flow|25 mg qd|Participants received an initial dose of Ruxolitinib 25 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely with dose adjustments for safety and efficacy.
443490|NCT00509899|P4|Participant Flow|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443491|NCT00509899|P3|Participant Flow|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443492|NCT00509899|P2|Participant Flow|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443493|NCT00509899|P1|Participant Flow|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443494|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443495|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443496|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443497|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443498|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443499|NCT00509899|O1|Outcome|All Participants|All participants received ruxolitinib at varying initial dose and regimen. Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443500|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443501|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443502|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443503|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443504|NCT00509899|O4|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443505|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443506|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443507|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443508|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443509|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443510|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443511|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443512|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443513|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443514|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443515|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443516|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443517|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443518|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443519|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443520|NCT00509899|O5|Outcome|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443521|NCT00509899|O4|Outcome|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443522|NCT00509899|O3|Outcome|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443523|NCT00509899|O2|Outcome|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443524|NCT00509899|O1|Outcome|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443568|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443569|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443525|NCT00509899|E5|Reported Event|All QD|Participants received an initial dose of Ruxolitinib 25, 50, 100 or 200 mg once a day (qd). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy. Since the numbers of patients in 3 of the qd treatment groups were small, the 4 qd doses were combined to allow meaningful comparisons against the bid treatment groups.
443526|NCT00509899|E4|Reported Event|50 mg Bid|Participants received an initial dose of Ruxolitinib 50 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443527|NCT00509899|E3|Reported Event|25 mg Bid|Participants received an initial dose of Ruxolitinib 25 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy.
443528|NCT00509899|E2|Reported Event|15 mg Bid|Participants received an initial dose of Ruxolitinib 15 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443529|NCT00509899|E1|Reported Event|10 mg Bid|Participants received an initial dose of Ruxolitinib 10 mg twice a day (bid). Participants could continue in the study on their prescribed regimen indefinitely if receiving benefit with dose adjustments for safety and efficacy to a maximum of 25 mg bid.
443530|NCT00509873|B3|Baseline|Total|Total of all reporting groups
443531|NCT00509873|B2|Baseline|Placebo Eye Drops|Placebo eye drops
443532|NCT00509873|B1|Baseline|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443533|NCT00509873|P2|Participant Flow|Placebo Eye Drops|Placebo eye drops
443534|NCT00509873|P1|Participant Flow|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443535|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
443536|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443537|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
443538|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443539|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
443540|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443541|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
443542|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443543|NCT00509873|O2|Outcome|Placebo Eye Drops|Placebo eye drops
443544|NCT00509873|O1|Outcome|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443545|NCT00509873|E2|Reported Event|Placebo Eye Drops|Placebo eye drops
443546|NCT00509873|E1|Reported Event|Gatifloxacin 0.5% Eye Drops|Gatifloxacin 0.5% eye drops
443547|NCT00509795|B5|Baseline|Total|Total of all reporting groups
443548|NCT00509795|B4|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443549|NCT00509795|B3|Baseline|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443550|NCT00509795|B2|Baseline|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443551|NCT00509795|B1|Baseline|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443552|NCT00509795|P4|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and received sham injections at interim monthly visits.
443553|NCT00509795|P3|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443554|NCT00509795|P2|Participant Flow|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443555|NCT00509795|P1|Participant Flow|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year.
443556|NCT00509795|O5|Outcome|Total|
443557|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443558|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443559|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443560|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443561|NCT00509795|O5|Outcome|Total|
443562|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443563|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443564|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443565|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443566|NCT00509795|O5|Outcome|Total|
443567|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443570|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443571|NCT00509795|O5|Outcome|Total|
443572|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443573|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443574|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443575|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443576|NCT00509795|O5|Outcome|Total|
443577|NCT00509795|O4|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits.
443578|NCT00509795|O3|Outcome|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443579|NCT00509795|O2|Outcome|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year.
443580|NCT00509795|O1|Outcome|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via IVT injection every 4 weeks for the first year.
443581|NCT00509795|E4|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q8|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 8 weeks (including one additional 2.0 mg dose at Week 4) for the first year and were to receive sham injections at interim monthly visits. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
443582|NCT00509795|E3|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 0.5mg Q4|Patients received a 0.5mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
443583|NCT00509795|E2|Reported Event|IAI (EYLEA, VEGF Trap-Eye) 2.0mg Q4|Patients received a 2.0mg dose of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of Intravitreal Aflibercept Injection (IAI, EYLEA, VEGF Trap-Eye) (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
443584|NCT00509795|E1|Reported Event|Ranibizumab 0.5mg Q4|Patients received a 0.5mg dose of ranibizumab via intravitreal (IVT) injection every 4 weeks for the first year. During the second year of treatment, patients were evaluated every 4 weeks and received IVT injections of ranibizumab (sham injections were not given) at intervals determined by specific re-treatment criteria. During this period, injections were given as frequently as every 4 weeks, but no less frequently than every 12 weeks.
443585|NCT00509769|B1|Baseline|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443586|NCT00509769|P1|Participant Flow|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443587|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443588|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443589|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443590|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443591|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443592|NCT00509769|O1|Outcome|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443593|NCT00509769|E1|Reported Event|Trastuzumab Emtansine 3.6 mg/kg|Patients received trastuzumab emtansine 3.6 mg/kg intravenously on Day 1 of each 21 day cycle for a maximum of 1 year. The total dose was dependent on the patient's weight on Day 1 of each cycle.
443594|NCT00509600|B1|Baseline|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
443595|NCT00509600|P1|Participant Flow|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
443596|NCT00509600|O1|Outcome|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
443597|NCT00509600|E1|Reported Event|Etanercept|0.8 mg/kg subcutaneously weekly for 90 days
443677|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
444716|NCT00506064|E2|Reported Event|Placebo|Starch capsules by mouth daily
443598|NCT00509587|B1|Baseline|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443599|NCT00509587|P1|Participant Flow|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443600|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443601|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443602|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443603|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443604|NCT00509587|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443605|NCT00509587|E1|Reported Event|Treatment (Pazopanib Hydrochloride)|"Patients receive oral pazopanib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given orally~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
443606|NCT00509496|B3|Baseline|Total|Total of all reporting groups
443607|NCT00509496|B2|Baseline|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443608|NCT00509496|B1|Baseline|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443609|NCT00509496|P2|Participant Flow|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443610|NCT00509496|P1|Participant Flow|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443611|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443612|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443613|NCT00509496|O2|Outcome|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443635|NCT00509366|E2|Reported Event|Cisplatin Sensitive (Post-Amendment)|Post-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
444717|NCT00506064|E1|Reported Event|Melatonin|0.15 mg/kg capsules by mouth daily
443614|NCT00509496|O1|Outcome|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443615|NCT00509496|E2|Reported Event|Anti-gp100:154-162 TCR TIL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered tumor infiltrating lymphocytes (TIL) cell preparation- minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443616|NCT00509496|E1|Reported Event|Anti-gp100:154-162 TCR PBL + HD IL-2|"fludarabine phosphate-25 mg/m^2/day intravenous piggy back over 30 minutes for 5 days~cyclophosphamide-60 mg/kg/day x 2 days intravenous~Anti-gp100:154-162 TCR-engineered peripheral blood lymphocyte (PBL) cell preparation - minimum of approximately 5 X 10^8 cells and up to 3 x10^11 anti-gp100:154-162 TCR engineered TIL or PBL. The cells are infused intravenously over 20-30 minutes.~aldesleukin-720,000 IU/kg intravenously over 15 minutes every 8 hours beginning within 24 hours of cell infusion and continuing for up to 5 days (maximum of 15 doses)"
443617|NCT00509366|B6|Baseline|Total|Total of all reporting groups
443618|NCT00509366|B5|Baseline|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis or those who were assigned treatment but not treated after reevaluation of their eligibility.
443619|NCT00509366|B4|Baseline|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to docetaxel/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
443620|NCT00509366|B3|Baseline|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study, assigned to cisplatin/gemcitabine resistant protocol-based treatment consistent with histology, and treated during the course of the study.
443621|NCT00509366|B2|Baseline|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/pemetrexed protocol-based treatment consistent with histology, and treated during the course of the study.
443622|NCT00509366|B1|Baseline|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study, assigned to cisplatin/gemcitabine protocol-based treatment consistent with histology, and treated during the course of the study.
443623|NCT00509366|P5|Participant Flow|Screen Failure|Screen failures constitute patients who were registered into the study but were not assigned to treatment due to unsuccessful genomic analysis. Nine patients did not undergo biopsy. Eight experienced complications from biopsy. The remaining 34 were deemed ineligible after genomic screening. Note that three patients who were assigned protocol-based treatment (2 in the cisplatin sensitive group and 1 in the cisplatin resistant group) did not receive the treatment and were added to the 51 initially identified as screen failures within the summary of baseline characteristics and outcome measures.
443624|NCT00509366|P4|Participant Flow|Docetaxel + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to docetaxel+ gemcitabine protocol-based treatment consistent with histology.
443625|NCT00509366|P3|Participant Flow|Pemetrexed + Gemcitabine|Cisplatin Resistant patients were registered at the start of the study and assigned to pemetrexed + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm was later deemed ineligible before initiating protocol treatment and was classified as a screen failure.
443626|NCT00509366|P2|Participant Flow|Cisplatin + Pemetrexed|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + pemetrexed protocol-based treatment consistent with histology. One patient who was assigned to this arm was deemed ineligible due to the discover of brain metastasis. This patient did not receive protocol treatment and was classified as a screen failure.
443627|NCT00509366|P1|Participant Flow|Cisplatin + Gemcitabine|Cisplatin Sensitive patients were registered at the start of the study and assigned to cisplatin + gemcitabine protocol-based treatment consistent with histology. One patient who was assigned to this arm withdrew from the study. This patient did not receive protocol treatment and was classified as a screen failure.
443628|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study.
443629|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive (cisplatin/pemetrexed or cisplatin/gemcitabine) and resistant (pemetrexed/gemcitabine or docetaxel/gemcitabine) arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
443630|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
443631|NCT00509366|O1|Outcome|Treatment|Treatment refers to the combined cisplatin sensitive and resistant arms of the study. Due to the irreproducibility of the genomics-based prediction model for assigning patients into the original cisplatin treatment arms, patients from both arms were combined for analysis.
443632|NCT00509366|E5|Reported Event|Screen Failure|Screen failures constitute patients who were registered into the study and underwent protocol-based procedure (e.g. biopsy, genomic screening), but were not enrolled to genomics-directed, protocol-based therapy. From the participant flow, 9 of the 54 screen failures did not have adverse event follow-up, resulting in a final count of 45 screen failures with adverse event follow-up.
443633|NCT00509366|E4|Reported Event|Cisplatin Resistant (Post-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated AFTER 1/25/2010.
443634|NCT00509366|E3|Reported Event|Cisplatin Resistant (Pre-Amendment)|Pre-amendment cisplatin resistant refers to patients who experienced adverse events and treated with cisplatin-resistant protocol based therapy per the amendment dated 1/25/2010.
443636|NCT00509366|E1|Reported Event|Cisplatin Sensitive (Pre-Amendment)|Pre-amendment cisplatin sensitive refers to patients who experienced adverse events and treated with cisplatin-sensitive protocol based therapy per the amendment dated 1/25/2010.
443637|NCT00509288|B3|Baseline|Total|Total of all reporting groups
443638|NCT00509288|B2|Baseline|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
443639|NCT00509288|B1|Baseline|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
443640|NCT00509288|P2|Participant Flow|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
443641|NCT00509288|P1|Participant Flow|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL). A minimum of approximately 5 X 10^8 cells will be given up to 3x10^11 anti-MART-1 F5 TCR engineered TIL or PBL. Day -7 to -5: Cyclophosphamide 60 mg/kg/day X 2 days intravenous (IV) in 250 ml D5W with mesna 15 mg/kg/day X 2 days over 1 hr. Day -5 to 1: Fludarabine 25 mg/m^2/day intravenous piggy back (IVPB) daily over 30 minutes for 5 days. Day 0: Cells will be infused intravenously (i.v.). Patients will receive up to 3x10e^11 (with a minimum of 5x10e^8 cells) anti-MART-1 F5 TCR engineered TIL or PBL Aldesleukin (based on total body weight) 720,000 IU/kg intravenous (IV) over 15 minute every eight hours beginning within 24 hours of cell infusion.
443642|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
443643|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
443644|NCT00509288|O2|Outcome|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
443645|NCT00509288|O1|Outcome|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
443646|NCT00509288|E2|Reported Event|Anti-MART-1 F5 TCR TIL + HD IL-2|Patients treated with tumor infiltrating lymphocytes (TIL).
443647|NCT00509288|E1|Reported Event|Anti-MART-1 F5 TCR PBL + HD IL-2|Patients treated with peripheral blood lymphocytes (PBL).
443648|NCT00509262|B3|Baseline|Total|Total of all reporting groups
443649|NCT00509262|B2|Baseline|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443650|NCT00509262|B1|Baseline|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443651|NCT00509262|P2|Participant Flow|Glipizide|Participants randomized to glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443652|NCT00509262|P1|Participant Flow|Sitagliptin|Participants randomized to 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443653|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443654|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443655|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443656|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443657|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443658|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443659|NCT00509262|O2|Outcome|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443660|NCT00509262|O1|Outcome|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443661|NCT00509262|E2|Reported Event|Glipizide|Participants received glipizide 2.5 to 20 mg orally daily + placebo for sitagliptin
443662|NCT00509262|E1|Reported Event|Sitagliptin|Participants received 25 or 50 mg of sitagliptin orally daily + placebo for glipizide
443663|NCT00509249|B1|Baseline|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
443664|NCT00509249|P1|Participant Flow|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
443665|NCT00509249|O1|Outcome|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
443666|NCT00509249|E1|Reported Event|Arm I|"Patients will receive aflibercept IV at 4 mg/kg over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
443667|NCT00509236|B3|Baseline|Total|Total of all reporting groups
443668|NCT00509236|B2|Baseline|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
443669|NCT00509236|B1|Baseline|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
443670|NCT00509236|P2|Participant Flow|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
443671|NCT00509236|P1|Participant Flow|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
443672|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
443673|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
443674|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
443675|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
443678|NCT00509236|O2|Outcome|Glipizide 2.5 mg - 20 mg|Participants received between 2.5 mg - 20 mg daily for 54 weeks
443679|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
443680|NCT00509236|O1|Outcome|Sitagliptin 25 mg|Participants received one 25 mg tablet once daily for 54 weeks
443681|NCT00509236|E2|Reported Event|Glipizide 2.5 mg - 20 mg|Between 2.5 mg - 20 mg daily for 54 weeks
443682|NCT00509236|E1|Reported Event|Sitagliptin 25 mg|One 25 mg tablet once daily for 54 weeks
443683|NCT00509223|B3|Baseline|Total|Total of all reporting groups
443684|NCT00509223|B2|Baseline|Lifestyle Counseling|
443685|NCT00509223|B1|Baseline|Lifestyle Counseling With PAP Therapy|
443686|NCT00509223|P2|Participant Flow|Group 2|"Lifestyle counseling without Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations."
443687|NCT00509223|P1|Participant Flow|Group 1|"Lifestyle counseling with Positive Airway Pressure (PAP) therapy~Lifestyle counseling: All subjects were counseled regarding adopting a healthy lifestyle and advised on the Heart Foundation, National Health and Medical Research Council, and American Diabetes Association nutrition and exercise recommendations.~Positive Airway Pressure therapy : PAP therapy was initiated at Randomization and continued through the entire study duration (6 months), with instructions for use on a daily basis, during periods of sleep."
443688|NCT00509223|O2|Outcome|Lifestyle Counseling|
443689|NCT00509223|O1|Outcome|Lifestyle Counseling With PAP Therapy|
443690|NCT00509223|E2|Reported Event|Lifestyle Counseling With PAP Therapy|
443691|NCT00509223|E1|Reported Event|Lifestyle Counseling|
443692|NCT00509197|B3|Baseline|Total|Total of all reporting groups
443693|NCT00509197|B2|Baseline|Placebo|Treatment with placebo
443694|NCT00509197|B1|Baseline|Fluticasone 500 mcg Bid|Treatment with inhaled corticosteroids
443695|NCT00509197|P2|Participant Flow|Placebo|treatment with placebo
443696|NCT00509197|P1|Participant Flow|Fluticasone 500 mcg Bid|Treatment with Inhaled Corticosteroids
443697|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
443698|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
443699|NCT00509197|O2|Outcome|Placebo|Treatment with placebo
443700|NCT00509197|O1|Outcome|Fluticasone|Treatment with Fluticasone
443701|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
443702|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
443703|NCT00509197|O2|Outcome|Placebo|Use of placebo inhaler (sham fluticasone)
443704|NCT00509197|O1|Outcome|Fluticasone|Treatment with inhaled corticosteroids
443705|NCT00509197|E2|Reported Event|Placebo|Treatment with placebo
443706|NCT00509197|E1|Reported Event|Fluticasone 500 mcg Bid|Treatment with inhaled Corticosteroids
443707|NCT00509106|B3|Baseline|Total|Total of all reporting groups
443708|NCT00509106|B2|Baseline|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
443709|NCT00509106|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
443710|NCT00509106|P2|Participant Flow|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
443711|NCT00509106|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
443712|NCT00509106|O2|Outcome|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
443713|NCT00509106|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
443714|NCT00509106|E2|Reported Event|IV Ceftriaxone|Ceftriaxone was administered as a 1-g IV infusion over 30 minutes followed by IV saline placebo infused over 30 minutes, every 24 hours (q24h).
443715|NCT00509106|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil was administered in two consecutive 300 mg IV infusions over 30 minutes, every 12 hours (q12h).
443716|NCT00509067|B3|Baseline|Total|Total of all reporting groups
443717|NCT00509067|B2|Baseline|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
443718|NCT00509067|B1|Baseline|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
443719|NCT00509067|P2|Participant Flow|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
443720|NCT00509067|P1|Participant Flow|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
443721|NCT00509067|O2|Outcome|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
443722|NCT00509067|O1|Outcome|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
443723|NCT00509067|E2|Reported Event|Placebos for Galantamine/CDP Choline|Participants assigned to receive placebo
443724|NCT00509067|E1|Reported Event|Galantamine/CDP Choline|Participants assigned to receive galantamine and CDP-choline
443725|NCT00509041|B1|Baseline|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443726|NCT00509041|P1|Participant Flow|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443727|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443728|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443729|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443730|NCT00509041|O1|Outcome|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443731|NCT00509041|E1|Reported Event|Dasatinib|Use of dasatinib (50 mg orally twice a day) in treatment of pts with previously treated malignant mesothelioma
443732|NCT00509028|B3|Baseline|Total|Total of all reporting groups
443733|NCT00509028|B2|Baseline|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443734|NCT00509028|B1|Baseline|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443735|NCT00509028|P2|Participant Flow|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443736|NCT00509028|P1|Participant Flow|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443737|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443738|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443739|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443740|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443741|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443742|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443743|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443744|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443745|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443746|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443747|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443748|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443749|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443750|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443751|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443752|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443753|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443754|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443755|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443756|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443757|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443758|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443759|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443760|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443761|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443762|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443763|NCT00509028|O2|Outcome|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443764|NCT00509028|O1|Outcome|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443765|NCT00509028|E2|Reported Event|Conventional Therapy|According to the Japanese Paediatric Guideline for the Treatment and Management of Asthma and at daily dose as judged by the investigator.
443766|NCT00509028|E1|Reported Event|Budesonide|Budesonide Turbuhaler 100 mcg (Pulmicort® Turbuhaler®), 100 - 400 mcg daily.
443767|NCT00508924|B5|Baseline|Total|Total of all reporting groups
443768|NCT00508924|B4|Baseline|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
443769|NCT00508924|B3|Baseline|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443770|NCT00508924|B2|Baseline|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443771|NCT00508924|B1|Baseline|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443772|NCT00508924|P4|Participant Flow|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
443773|NCT00508924|P3|Participant Flow|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443774|NCT00508924|P2|Participant Flow|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443775|NCT00508924|P1|Participant Flow|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443776|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
443777|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443778|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443779|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443780|NCT00508924|O4|Outcome|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
443781|NCT00508924|O3|Outcome|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443782|NCT00508924|O2|Outcome|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443783|NCT00508924|O1|Outcome|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443784|NCT00508924|E4|Reported Event|Heparin|"70-100 IU/kg i.v. bolus~additional 2,000-5,000 IU boluses could be given in order to reach the target ACT level of 250 sec"
443785|NCT00508924|E3|Reported Event|ARG350|"350μg/kg i.v. bolus followed by infusion of 25μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443786|NCT00508924|E2|Reported Event|ARG300|"300μg/kg i.v. bolus followed by infusion of 20μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443787|NCT00508924|E1|Reported Event|ARG250|"250μg/kg i.v. bolus of argatroban followed by infusion of 15μg/kg/min~additional 150μg/kg i.v. boluses (maximum 2 additional) could be given in order to reach the target ACT level of 250 sec"
443788|NCT00508872|B1|Baseline|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
443789|NCT00508872|P1|Participant Flow|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
443790|NCT00508872|O1|Outcome|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
443791|NCT00508872|E1|Reported Event|FOLFOX-B|FOLFOX-B: 5-Fluorouracil 400 mg/m^2 IV + Bevacizumab 5 mg/kg IV + Leucovorin 400 mg/m^2 IV + Oxaliplatin 85 mg/m^2 IV
443792|NCT00508820|B3|Baseline|Total|Total of all reporting groups
443793|NCT00508820|B2|Baseline|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
443794|NCT00508820|B1|Baseline|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
443795|NCT00508820|P2|Participant Flow|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
443796|NCT00508820|P1|Participant Flow|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
443797|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
443798|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
443799|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
443800|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
443801|NCT00508820|O2|Outcome|Romiplostim (AMG 531) Cohort 2|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under protocol amendments 4 where starting dose was 1mcg/kg.
443802|NCT00508820|O1|Outcome|Romiplostim (AMG 531) Cohort 1|Romiplostim administered to participants subcutaneously weekly based on platelet counts. Participants were enrolled under the original protocol or protocol amendments 1-3 where starting dose was 3mcg/kg.
443803|NCT00508820|E2|Reported Event|Romiplostim Cohort 2|
443804|NCT00508820|E1|Reported Event|Romiplostim Cohort 1|
443805|NCT00508755|B1|Baseline|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
443806|NCT00508755|P1|Participant Flow|Gait Training After Stroke|Subjects with chronic stroke (.5-1.5 years post stroke) received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and gait robot.
443807|NCT00508755|O3|Outcome|Combined Gait Robot and FES|The 6 study subjects with chronic stroke ambulated with combination Gait Robot and FES, and observational gait analysis was performed.
443808|NCT00508755|O2|Outcome|FES-Alone|The 6 study subjects with chronic stroke ambulated with FES, and observational gait analysis was performed.
443809|NCT00508755|O1|Outcome|Gait Robot-alone Training|The 6 study subjects with chronic stroke ambulated in the Gait Robot, and observational gait analysis was performed.
443810|NCT00508755|E1|Reported Event|Gait Training After Stroke|subjects with Chronic stroke (.5-1.5 years post stroke)received gait training with the use of functional neuromuscular stimulation with intramuscular electrodes and Gait Robot.
443811|NCT00508742|B3|Baseline|Total|Total of all reporting groups
443812|NCT00508742|B2|Baseline|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443813|NCT00508742|B1|Baseline|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443814|NCT00508742|P2|Participant Flow|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443815|NCT00508742|P1|Participant Flow|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443816|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443817|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443818|NCT00508742|O2|Outcome|7vPnC|7-valent pneumococcal conjugate vaccine (7vPnC) 0.5 mL dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443819|NCT00508742|O1|Outcome|13vPnC|13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) dose administered intramuscularly at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose).
443820|NCT00508742|E8|Reported Event|After Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
443821|NCT00508742|E7|Reported Event|After Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age in toddler dose, assessed after the toddler dose blood draw through the Month 24 visit.
443822|NCT00508742|E6|Reported Event|Toddler Dose 7vPnC|Participants who received 7vPnC 0.5 mL dose intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
443823|NCT00508742|E5|Reported Event|Toddler Dose 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 12 months of age (toddler dose), assessed from the toddler dose through the blood draw 1 month after the toddler dose.
443824|NCT00508742|E4|Reported Event|After Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
443825|NCT00508742|E3|Reported Event|After Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4, and 6 months of age in infant series, assessed after the infant series blood draw to the toddler dose.
443826|NCT00508742|E2|Reported Event|Infant Series 7vPnC|Participants who received 7vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
443827|NCT00508742|E1|Reported Event|Infant Series 13vPnC|Participants who received 13vPnC 0.5 mL intramuscularly at 2, 4 and 6 months of age (infant series), assessed from dose 1 of the infant series through the blood draw 1 month after the infant series.
443828|NCT00508716|B3|Baseline|Total|Total of all reporting groups
443829|NCT00508716|B2|Baseline|Tailored Intervention for Patients With Low Health Literacy an|"Tailored Intervention for patients with low health literacy and nurse-directed teachback~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
443830|NCT00508716|B1|Baseline|Usual Care|CHF Education by usual Nurse without teach-back or Video.
443831|NCT00508716|P2|Participant Flow|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
443832|NCT00508716|P1|Participant Flow|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
443833|NCT00508716|O2|Outcome|Tailored Low Health Literacy Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
443834|NCT00508716|O1|Outcome|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
443864|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
444013|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
443835|NCT00508716|E2|Reported Event|Teilored Intervention|"Tailored Intervention for patients with low health literacy and nurse-directed teachback: Educational leaflet which has been developed for low-health literacy patients. Adminstered by dedicated Nurse-educator. Nurse-educator asks Patient for teachback after Intervention. This means that the Patient repeats in his/her own words the Information received. Education ends once Patient has been able to repeat the Information back.~Health Literacy-Tailored Education: Intervention group receives a visit from a nurse educator who, using the teach back method of educating patients, provides counseling on their disease methods of controlling their disease. A video is also viewed to reinforce the materials."
443836|NCT00508716|E1|Reported Event|Usual Care|Usual Care - Education about CHF by Primary Nurse on discharge. No teach-back is used in this arm.
443837|NCT00508651|B3|Baseline|Total|Total of all reporting groups
443838|NCT00508651|B2|Baseline|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443839|NCT00508651|B1|Baseline|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443840|NCT00508651|P2|Participant Flow|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443841|NCT00508651|P1|Participant Flow|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443842|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443843|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443844|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443845|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443846|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443847|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443848|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443849|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443850|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443851|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443852|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443853|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443854|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443855|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443856|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443857|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443858|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443859|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443860|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443861|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443862|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443863|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
444057|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
443865|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443866|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443867|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443868|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443869|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443870|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443871|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443872|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443873|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443874|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443875|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443876|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443877|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443878|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443879|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443880|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443881|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443882|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443883|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443884|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443885|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443886|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443887|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443888|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443889|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443890|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443891|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443892|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443893|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443894|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
444088|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
444718|NCT00506025|B4|Baseline|Total|Total of all reporting groups
443895|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443896|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443897|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443898|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443899|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443900|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443901|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443902|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443903|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443904|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443905|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443906|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443907|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443908|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443909|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443910|NCT00508651|O2|Outcome|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443911|NCT00508651|O1|Outcome|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443912|NCT00508651|E2|Reported Event|Cohort 1 Placebo|Placebo was a frozen preparation filled into Becton Dickinson™ Luer slip-tip syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
443913|NCT00508651|E1|Reported Event|Cohort 1 MEDI-560|MEDI-560 vaccine was a frozen preparation of live, attenuated rHPIV3cp45 virus filled into Becton Dickinson™ Luer slip tip syringes. Each 0.2 mL dose contained 10^5 TCID50 of MEDI 560 in a sucrose phosphate glutamate buffer.
443914|NCT00508521|B1|Baseline|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
443915|NCT00508521|P1|Participant Flow|FES and Motor Learning Training Group|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
443916|NCT00508521|O1|Outcome|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
443917|NCT00508521|E1|Reported Event|Arm 1 Subjects With Acute Stroke|Subjects < 6 months following first stroke who had diminished upper limb strength, coordination and function.
443918|NCT00508482|B4|Baseline|Total|Total of all reporting groups
443919|NCT00508482|B3|Baseline|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443920|NCT00508482|B2|Baseline|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443921|NCT00508482|B1|Baseline|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443922|NCT00508482|P3|Participant Flow|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443923|NCT00508482|P2|Participant Flow|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443924|NCT00508482|P1|Participant Flow|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443925|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443926|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443927|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443928|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443929|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443930|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443931|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443932|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443933|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443934|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443935|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443936|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443937|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443938|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443939|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
444139|NCT00507767|B1|Baseline|Dasatinib|100 mg orally twice daily
443940|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443941|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443942|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443943|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443944|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443945|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443946|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443947|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443948|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443949|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443950|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443951|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443952|NCT00508482|O3|Outcome|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443953|NCT00508482|O2|Outcome|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
443954|NCT00508482|O1|Outcome|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443955|NCT00508482|E3|Reported Event|Lactulose Group|Lactulose Oral Solution was taken orally at the dose of 20~30ml once every morning after breakfast for continuous 4 weeks. Patients should take lactulose for another 3 months if no severe adverse effect was showed.
443956|NCT00508482|E2|Reported Event|Shallow Needling Group|Bilateral ST25, the same acupoints as deep needling group, were used. After skin disinfection, needles of the size of 0.30×25mm penetrated the skin uprightly for about 5~9mm into the fat layer without manipulation. The usage of EA apparatus and treatment course were the same as deep needling group.
444140|NCT00507767|P1|Participant Flow|Dasatinib|100 mg orally twice daily
444141|NCT00507767|O1|Outcome|Dasatinib|100 mg orally twice daily
443957|NCT00508482|E1|Reported Event|Deep Needling Group|"Acupoints of bilateral Tianshu (ST25), which were located according to WHO Standardized Acupuncture Points Location20, were used.~After sterilizing the skin, needles of the size of 0.35×0.75mm were inserted into ST25 vertically and slowly without manipulation for about 30~70mm until touching the parietal peritoneum. Paired alligator clips of the EA apparatus were attached transversely to the needle holders of bilateral ST25. EA stimulation lasted for 30 minutes with a dilatational wave of 2/15Hz and current intensity of 0.1~1mA. Participant's abdominal muscle twitching mildly showed the proper dose.~Patients were treated once a day, five times a week for continuous 4 weeks."
443958|NCT00508469|B3|Baseline|Total|Total of all reporting groups
443959|NCT00508469|B2|Baseline|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
443960|NCT00508469|B1|Baseline|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
443961|NCT00508469|P2|Participant Flow|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
443962|NCT00508469|P1|Participant Flow|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
443963|NCT00508469|O2|Outcome|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
443964|NCT00508469|O1|Outcome|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
443965|NCT00508469|E2|Reported Event|Travalert With Travoprost and Timolol|One drop travoprost in the study eye at 9 p.m. and one drop of timolol in the study eye twice daily (9 a.m. and 9 p.m.) for six months using a separate Travalert device for each medication.
443966|NCT00508469|E1|Reported Event|Travalert With Travoprost/Timolol Fixed Combination|One drop in the study eye once daily at 9 p.m. for six months using the Travalert device.
443967|NCT00508404|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443968|NCT00508404|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443969|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443970|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443971|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443972|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443973|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443974|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443975|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443976|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443977|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443978|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443979|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443980|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443981|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443982|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443983|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443984|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443985|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443986|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443987|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443988|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443989|NCT00508404|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443990|NCT00508404|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443991|NCT00508404|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until diagnosed with radiographic disease progression.
443992|NCT00508391|B3|Baseline|Total|Total of all reporting groups
443993|NCT00508391|B2|Baseline|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
443994|NCT00508391|B1|Baseline|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
443995|NCT00508391|P2|Participant Flow|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
443996|NCT00508391|P1|Participant Flow|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
443997|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
443998|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
443999|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
444000|NCT00508391|O3|Outcome|Total Subjects|Total subjects enrolled in study.
444001|NCT00508391|O2|Outcome|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
444002|NCT00508391|O1|Outcome|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
444003|NCT00508391|E3|Reported Event|Total Subjects|Total subjects enrolled in study.
444004|NCT00508391|E2|Reported Event|Optimized 1st, Simultaneous 2nd|Lumax HF-T device programmed to optimized biventricular pacing first for 30 days, followed by simultaneous biventricular pacing for 30 days.
444005|NCT00508391|E1|Reported Event|Simultaneous 1st, Optimized 2nd|Lumax HF-T device programmed to simultaneous biventricular pacing first for 30 days, followed by optimized biventricular pacing for 30 days.
444006|NCT00508274|B1|Baseline|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444007|NCT00508274|P1|Participant Flow|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444008|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444009|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444010|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444011|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444012|NCT00508274|O1|Outcome|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444142|NCT00507767|E1|Reported Event|Dasatinib|100 mg orally twice daily
444143|NCT00507689|B4|Baseline|Total|Total of all reporting groups
444014|NCT00508274|E1|Reported Event|Lapatinib + Capecitabine|Daily oral lapatinib (1250 mg/day) in combination with capecitabine (2000 mg/m2/day on Days 1-14 every 21 Days); m2 = Square meter: Body Surface Area
444015|NCT00508157|B3|Baseline|Total|Total of all reporting groups
444016|NCT00508157|B2|Baseline|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444017|NCT00508157|B1|Baseline|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444018|NCT00508157|P2|Participant Flow|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444019|NCT00508157|P1|Participant Flow|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444020|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444021|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444022|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444023|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444024|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444025|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444026|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444027|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444028|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444029|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444030|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444031|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444032|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444033|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444034|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444719|NCT00506025|B3|Baseline|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
444035|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444036|NCT00508157|O2|Outcome|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444037|NCT00508157|O1|Outcome|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444038|NCT00508157|E2|Reported Event|Control Group|Olanzapine 5 mg and 10 mg, risperidone 1 mg and 4 mg, and quetiapine 100 mg and 200 mg oral tablets. Participants entered the study at the same dose as prior to randomization. Dose adjustments during the study were allowed within the dose range specified in the respective Summaries of Product Characteristics (SmPCs), according the investigator’s judgment. Participants were treated for 16 weeks.
444039|NCT00508157|E1|Reported Event|Aripiprazole|Aripiprazole 5 mg, 10 mg, and 15 mg tablets: 5 mg once daily (QD) orally during the first week; 10 mg QD orally during the second week. Dosing was adjusted in 5 mg increments every 7 days within a range of 10 to 30 mg daily. Participants were treated for 16 weeks.
444040|NCT00508144|B1|Baseline|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
444041|NCT00508144|P1|Participant Flow|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
444042|NCT00508144|O1|Outcome|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
444043|NCT00508144|E1|Reported Event|Alimta|Alimta 500 mg/m^2 by vein once over 10 minutes every 3 weeks.
444044|NCT00508118|B3|Baseline|Total|Total of all reporting groups
444045|NCT00508118|B2|Baseline|0.9% Saline|0.9% saline (placebo) before bypass
444046|NCT00508118|B1|Baseline|Nicardipine|Nicardipine infusion before bypass
444047|NCT00508118|P2|Participant Flow|0.9% Saline|0.9% saline (placebo) infusion before bypass
444048|NCT00508118|P1|Participant Flow|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444049|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444050|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444051|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444052|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444053|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444054|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444055|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444056|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444058|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444059|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444060|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444061|NCT00508118|O2|Outcome|0.9% Saline|0.9% saline (placebo) infusion before bypass
444062|NCT00508118|O1|Outcome|Nicardipine|"Nicardipine infusion before bypass~After enrollment of 7 patients the operating surgeon (also a study collaborator) commented that 3 of the patients appeared to have required more vasopressor support than was usual in his practice and so these patient allocations were unblinded. All 3 had been randomized to receive nicardipine. Thus, even if all 7 enrolled so far had been randomized to active drug this would have meant an incidence of at least 37.5% requiring increased vasopressor use. After discussion with the surgeon (Dr Hughes), and the other co-investigators it is the decision of the study team and PI that this protocol is not able to safely answer the research question posed and thus further enrollment would be inappropriate. One subject cannot be accounted for as to treatment arm. No further documentation available."
444063|NCT00508118|O1|Outcome|NICARDIPINE GROUP|Nicardipine prior to bypass
444064|NCT00508118|E2|Reported Event|0.9% Saline|0.9% saline (placebo) before bypass
444065|NCT00508118|E1|Reported Event|Nicardipine|Nicardipine infusion before bypass
444066|NCT00508027|B1|Baseline|Simvastatin, Dose Escalation|"There are no arms in this study. Simvastatin will be given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Simvastatin : Comparison of 3 dosages of simvastatin given in a dose-escalating fashion.~20 mg, 40 mg, or 80 mg PO QD x 21 days followed by a drug taper x 4 days."
444067|NCT00508027|P1|Participant Flow|Simvastatin, 3 Escalating Dose Groups|"Simvastatin was given in a dose-escalating fashion to 3 sequential dose groups:~dose level 1= 20 mg/day, dose level 2= 40 mg/day, dose level 3= 80 mg/day The number of subjects starting each dose level are new cohorts of subjects.~Determination of clinical safety in the first dose level group was required in order to begin enrollment in the second dose level group and ultimately the third dose group. Enrollment in the third dose level was discontinued early due to newly reported FDA warnings regarding high dose (80mg/day) simvastatin."
444068|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444069|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444070|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
444071|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444072|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444073|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
444074|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444075|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444076|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
444077|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444078|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444079|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
444080|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|"Subjects received 80 mg daily. Data collected for only 2 participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage"
444081|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444082|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20 mg of simvastatin once daily
444083|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444084|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444085|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
444086|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444087|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444089|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444090|NCT00508027|O2|Outcome|Dose Level 2|All participants received 40 mg of simvastatin once daily
444091|NCT00508027|O1|Outcome|Dose Level 1|All participants received 20mg simvastatin once daily
444092|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444093|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444094|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
444095|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; only descriptive clinical data collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444096|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444097|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
444098|NCT00508027|O3|Outcome|Simvastatin, Dose Level 3|subject received 80 mg daily; biomarker data were not collected for participants enrolled in Dose Level 3 (80mg/day) due to discontinuation for recent FDA restriction on daily dosage
444099|NCT00508027|O2|Outcome|Simvastatin, Dose Level 2|All participants received 40 mg of simvastatin once daily
444100|NCT00508027|O1|Outcome|Simvastatin, Dose Level 1|All participants received 20mg simvastatin once daily
444101|NCT00508027|E3|Reported Event|Simvastatin, Dose 3|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 3 = 80mg/day for 21 days, followed by 4-day drug taper. Enrollment in this group discontinued early due to FDA warning re. high dose simvastatin"
444102|NCT00508027|E2|Reported Event|Simvastatin, Dose 2|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 2 = 40mg/day for 21 days, followed by a 4-day taper."
444103|NCT00508027|E1|Reported Event|Simvastatin, Dose 1|"Simvastatin given in a dose-escalating fashion to 3 sequential dosage groups (20 mg/day, 40 mg/day, 80 mg/day).~Dose 1 = 20mg/day for 21 days, followed by 4-day drug taper."
444104|NCT00508001|B4|Baseline|Total|Total of all reporting groups
444105|NCT00508001|B3|Baseline|Placebo|Placebo plus Best Support Care
444106|NCT00508001|B2|Baseline|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444107|NCT00508001|B1|Baseline|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444108|NCT00508001|P3|Participant Flow|Placebo|Placebo plus Best Support Care
444109|NCT00508001|P2|Participant Flow|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444110|NCT00508001|P1|Participant Flow|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444111|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
444112|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444113|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444114|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
444115|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444116|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444117|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
444118|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444119|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444120|NCT00508001|O3|Outcome|Placebo|Placebo plus Best Support Care
444121|NCT00508001|O2|Outcome|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444122|NCT00508001|O1|Outcome|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444123|NCT00508001|E3|Reported Event|Placebo|Placebo plus Best Support Care
444124|NCT00508001|E2|Reported Event|ZD6474 100|ZD6474 (Vandetanib) 100 mg (one tablet per day, orally). plus Best Support Care
444125|NCT00508001|E1|Reported Event|ZD6474 300|ZD6474 (Vandetanib) 300 mg ( one tablet per day, orally). plus Best Support Care
444126|NCT00507819|B1|Baseline|Study Population|Subjects who were randomized to receive either Sildenafil 20mg three times a day by mouth or Placebo three times a day by mouth.
444127|NCT00507819|P2|Participant Flow|Placebo, Then Sildenafil|Placebo six weeks followed by a six week washout period followed by Sildenafil which will be given at a dose of 20 mg three times-a-day for six weeks
444128|NCT00507819|P1|Participant Flow|Sildenafil, Then Placebo|Sildenafil will be given at a dose of 20 mg three times-a-day for six weeks followed by a six week washout period followed by placebo for an additional six weeks.
444129|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
444130|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
444131|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
444132|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
444133|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
444134|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
444135|NCT00507819|O2|Outcome|Placebo|Placebo was given by mouth three times a day for six weeks
444136|NCT00507819|O1|Outcome|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
444137|NCT00507819|E2|Reported Event|Placebo|Placebo was given by mouth three times a day for six weeks
444138|NCT00507819|E1|Reported Event|Sildenafil|Sildenafil was given by mouth at a dose of 20 mg three times a day for six weeks
444144|NCT00507689|B3|Baseline|Not Randomized|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period only. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444145|NCT00507689|B2|Baseline|FTC/TDF|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444146|NCT00507689|B1|Baseline|FTC/TDF+HBIg|For Baseline Characteristics, this group includes participants who received FTC/TDF+HBIg in the pre-randomization period, and were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444147|NCT00507689|P2|Participant Flow|FTC/TDF|For the Participant Flow, this group includes participants who received FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily.
444148|NCT00507689|P1|Participant Flow|FTC/TDF+HBIg|For the Participant Flow, this group includes all participants who received any treatment in the pre-randomization period, and participants who received FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444149|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444150|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444151|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444152|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444153|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444154|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444155|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444156|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444157|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444158|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444159|NCT00507689|O2|Outcome|FTC/TDF|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444160|NCT00507689|O1|Outcome|FTC/TDF+HBIg|Participants received FTC/TDF+HBIg for up to 24 weeks in the pre-randomization period; those who completed 24 weeks of treatment were then randomized to receive FTC/TDF+HBIg in the randomized period. FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444161|NCT00507689|E3|Reported Event|FTC/TDF, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444162|NCT00507689|E2|Reported Event|FTC/TDF+HBIg, Randomized Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the randomized period, and were analyzed from randomization (at the Week 24 visit) to Week 96 (randomized period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444212|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444163|NCT00507689|E1|Reported Event|FTC/TDF+HBIg, Pre-randomization Period|For the reporting of Adverse Events, this group includes participants who received FTC/TDF+HBIg during the pre-randomization period, and were analyzed from pretreatment baseline to Week 24 (pre-randomization period). FTC (200 mg)/TDF (300 mg) was administered as a fixed-dose combination tablet orally once daily. HBIG was administered according to site-specific protocols.
444164|NCT00507559|B1|Baseline|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444165|NCT00507559|P1|Participant Flow|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444166|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444167|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444168|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444169|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444170|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444171|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444172|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444173|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444174|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444175|NCT00507559|O1|Outcome|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444176|NCT00507559|E1|Reported Event|AAA Repair System|Aptus Endovascular AAA Repair System: EVAR
444177|NCT00507546|B3|Baseline|Total|Total of all reporting groups
444178|NCT00507546|B2|Baseline|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
444179|NCT00507546|B1|Baseline|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
444180|NCT00507546|P2|Participant Flow|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
444181|NCT00507546|P1|Participant Flow|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
444182|NCT00507546|O2|Outcome|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
444183|NCT00507546|O1|Outcome|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
444184|NCT00507546|O2|Outcome|Placebo|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
444185|NCT00507546|O1|Outcome|Ramelteon|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
444186|NCT00507546|E2|Reported Event|Arm 2|"Placebo then ramelteon~Placebo : Nightly 8mg of placebo (same appearance as ramelteon)"
444187|NCT00507546|E1|Reported Event|Arm 1|"Ramelteon then placebo~Ramelteon : 8 mg nightly"
444188|NCT00507507|B3|Baseline|Total|Total of all reporting groups
444189|NCT00507507|B2|Baseline|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444190|NCT00507507|B1|Baseline|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444191|NCT00507507|P2|Participant Flow|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444192|NCT00507507|P1|Participant Flow|Tenofovir DF|Participants were randomized to receive tenofovir disoproxil fumarate (tenofovir DF; 300 mg tablet) plus placebo to match emtricitabine (FTC; tablet) orally once daily.
444193|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444194|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444195|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444196|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444197|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444198|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444199|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444200|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444201|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444202|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444203|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444204|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444205|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444206|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444207|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444208|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444209|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444210|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444211|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
451554|NCT00485472|E2|Reported Event|Placebo|Placebo
444213|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444214|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444215|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444216|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444217|NCT00507507|O2|Outcome|FTC+Tenofovir DF|Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.
444218|NCT00507507|O1|Outcome|Tenofovir DF|Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.
444219|NCT00507507|E4|Reported Event|FTC+Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the FTC+Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
444220|NCT00507507|E3|Reported Event|Tenofovir DF (24-week Treatment-free Follow-up Period)|"This reporting group includes participants randomized to the Tenofovir DF group who permanently discontinued study drug on or before the last subject reached Week 192 and were followed for 24 weeks off treatment or until initiation of alternative HBV therapy, whichever occurred first.~AEs reported for this reporting group are those that occurred during the 24-week treatment-free follow-up period only."
444221|NCT00507507|E2|Reported Event|FTC+Tenofovir DF (Treatment Period)|"Participants were randomized to receive FTC (200 mg tablet) plus tenofovir DF (300 mg tablet) orally once daily.~AEs for this reporting group are reported for the entire treatment period."
444222|NCT00507507|E1|Reported Event|Tenofovir DF (Treatment Period)|"Participants were randomized to receive tenofovir DF (300 mg tablet) plus placebo to match FTC (tablet) orally once daily.~Adverse events (AEs) for this reporting group are reported for the entire treatment period."
444223|NCT00507455|B4|Baseline|Total|Total of all reporting groups
444224|NCT00507455|B3|Baseline|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444225|NCT00507455|B2|Baseline|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444226|NCT00507455|B1|Baseline|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444227|NCT00507455|P3|Participant Flow|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS)tablets for 12 weeks.
444228|NCT00507455|P2|Participant Flow|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin hydrochloride Oral Control Absorption System (TOCAS) tablets for 12 weeks.
444229|NCT00507455|P1|Participant Flow|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444230|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444231|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444232|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444233|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444234|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444235|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444236|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444237|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444238|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444239|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444240|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444241|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444242|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444243|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444244|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444245|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444246|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444247|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444444|NCT00507130|B4|Baseline|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444248|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444249|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444250|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444251|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444252|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444253|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444254|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444255|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444256|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444257|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444258|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444259|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444260|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444261|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444262|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444263|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444264|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444265|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444266|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444267|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444268|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444269|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444270|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444271|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444272|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444273|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444274|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444275|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444276|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444277|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444278|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444279|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444280|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444281|NCT00507455|O3|Outcome|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444282|NCT00507455|O2|Outcome|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444283|NCT00507455|O1|Outcome|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444284|NCT00507455|E3|Reported Event|9 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 9 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444285|NCT00507455|E2|Reported Event|6 mg Solifenacin + 0.4 mg Tamsulosin|Participants received once daily, oral doses of 6 mg solifenacin succinate and 0.4 mg tamsulosin tablets for 12 weeks.
444286|NCT00507455|E1|Reported Event|Placebo|Participants received once daily, oral doses of placebo matching solifenacin succinate and tamsulosin tablets for 12 weeks.
444287|NCT00507442|B5|Baseline|Total|Total of all reporting groups
444288|NCT00507442|B4|Baseline|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444289|NCT00507442|B3|Baseline|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444290|NCT00507442|B2|Baseline|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444291|NCT00507442|B1|Baseline|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444292|NCT00507442|P4|Participant Flow|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444293|NCT00507442|P3|Participant Flow|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444294|NCT00507442|P2|Participant Flow|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444295|NCT00507442|P1|Participant Flow|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444296|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444297|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444298|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444299|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444300|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444301|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444302|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444303|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444304|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444406|NCT00503984|P5|Participant Flow|Phase 2 - Aza + Doc Initial RPTD|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
444305|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444306|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444307|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444308|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444309|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444310|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444311|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444312|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444313|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444314|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444315|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444316|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444317|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444318|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444319|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444320|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444321|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444322|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444323|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444438|NCT00503906|O1|Outcome|Single Arm|This is a single arm study
444324|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444325|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444326|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444327|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444328|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444329|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444330|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444331|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444332|NCT00507442|O4|Outcome|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444333|NCT00507442|O3|Outcome|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444334|NCT00507442|O2|Outcome|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444335|NCT00507442|O1|Outcome|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444336|NCT00507442|O4|Outcome|VDC-mod|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444337|NCT00507442|O3|Outcome|V-DC|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444338|NCT00507442|O2|Outcome|VDCR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444339|NCT00507442|O1|Outcome|V-DR|"Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444340|NCT00507442|E4|Reported Event|VDC-mod|"Modified dosing of VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop."
444341|NCT00507442|E3|Reported Event|V-DC|"VELCADE (bortezomib), dexamethasone, cyclophosphamide Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop."
444439|NCT00503906|O1|Outcome|Single Arm|This is a single arm study
444342|NCT00507442|E2|Reported Event|VDCR|"VELCADE (bortezomib), dexamethasone, cyclophosphamide, Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg PO on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Cyclophosphamide: 100 - 500 mg/m^2 dose PO on Days 1 and 8 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 15 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444343|NCT00507442|E1|Reported Event|V-DR|"VELCADE (bortezomib), dexamethasone, and Revlimid (lenalidomide) Bortezomib: 1.3 mg/m^2/dose IV on Days 1, 4, 8, and 11 of a 3-week cycle for 8 cycles, then on Days 1, 8, 15, and 22 of a 6-week cycle for 4 cycles.~Dexamethasone: 40 mg orally [PO] on Days 1, 8, and 15 of a 3-week cycle for 8 cycles, then stop.~Lenalidomide: 25 mg PO on Days 1 through 14 of a 3-week cycle for 8 cycles, then stop."
444344|NCT00507429|B3|Baseline|Total|Total of all reporting groups
444345|NCT00507429|B2|Baseline|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
444346|NCT00507429|B1|Baseline|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
444347|NCT00507429|P2|Participant Flow|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
444348|NCT00507429|P1|Participant Flow|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
444349|NCT00507429|O2|Outcome|Arm 2, Control: Carboplatin + Paclitaxel|On Day 2 of six 21-cycles subjects received Carboplatin (AUC 6) + paclitaxel (200 mg/m2). Subjects without progressive disease were followed monthly for survival.
444350|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Randomized 2:1 to receive six 21-day cycles of CA4P (60mg/m2)on days 1, 8, 15 + carboplatin (AUC 6) + paclitaxel (200 mg/m2) on Day 2. Subjects without progressive disease may continue maintenance CA4P infusions until progressive disease, then followed monthly for survival.
444351|NCT00507429|O2|Outcome|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
444352|NCT00507429|O1|Outcome|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
444353|NCT00507429|E2|Reported Event|Arm 2, Comparator: Carboplatin + Paclitaxel|Six 21-day cycles of carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 1
444354|NCT00507429|E1|Reported Event|Arm 1, Active: CA4P + Carboplatin + Paclitaxel|Six 21-day cycles of CA4P (60 mg/m2) on days 1, 8, 15, carboplatin (AUC 6) and paclitaxel (200 mg/m2) on Day 2
444355|NCT00507416|B4|Baseline|Total|Total of all reporting groups
444356|NCT00507416|B3|Baseline|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444357|NCT00507416|B2|Baseline|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444358|NCT00507416|B1|Baseline|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444359|NCT00507416|P3|Participant Flow|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444360|NCT00507416|P2|Participant Flow|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444361|NCT00507416|P1|Participant Flow|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444362|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444363|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444440|NCT00503906|O1|Outcome|Abraxane, Bevacizumab and Gemcitabine|This is a single arm study
444441|NCT00503906|O1|Outcome|Single Arm|This is a single arm study
444364|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444365|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444366|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444367|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444368|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444369|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444370|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444371|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444372|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444373|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444374|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444375|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444376|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444377|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444378|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444379|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444380|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444442|NCT00503906|E1|Reported Event|Single Arm|This is a single arm study
444381|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444382|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444383|NCT00507416|O3|Outcome|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444384|NCT00507416|O2|Outcome|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444385|NCT00507416|O1|Outcome|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444386|NCT00507416|E3|Reported Event|Bortezomib, Melphalan and Prednisone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and melphalan 9 mg/m^2 orally on Days 1-4 every other cycle and prednisone 60 mg/m^2 orally on Days 1-4 every other cycle for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444387|NCT00507416|E2|Reported Event|Bortezomib, Thalidomide, and Dexamethasone|Participants received bortezomib 1.3 mg/m^2 administered as a bolus IV injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12, and thalidomide 100 mg orally on Days 1-21 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444388|NCT00507416|E1|Reported Event|Bortezomib and Dexamethasone|Participants received bortezomib (Velcade) 1.3 mg/m^2 administered as a bolus intravenous (IV) injection on Days 1, 4, 8, and 11, and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 and 12 for eight 21-day treatment cycles (Induction). Participants then received bortezomib 1.6 mg/^2 IV on Days 1, 8, 15 and 22 for five 35-day cycles (Maintenance).
444389|NCT00507208|B3|Baseline|Total|Total of all reporting groups
444390|NCT00507208|B2|Baseline|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
444391|NCT00507208|B1|Baseline|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
444392|NCT00507208|P2|Participant Flow|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
444393|NCT00507208|P1|Participant Flow|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
444394|NCT00507208|O2|Outcome|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
444395|NCT00507208|O1|Outcome|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
444396|NCT00507208|E2|Reported Event|Control|Participants randomized to this arm will use tongue depressors for 3 months and if there is no improvement in their mouth opening at this timepoint, they will crossover to the Dynasplint Trismus System for 3 months.
444397|NCT00507208|E1|Reported Event|Dynasplint|Participants randomized to this arm will be treated with the Dynasplint Trismus System
444398|NCT00503997|B1|Baseline|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
444399|NCT00503997|P1|Participant Flow|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
444400|NCT00503997|O1|Outcome|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
444401|NCT00503997|E1|Reported Event|Pemetrexed/Oxaliplatin|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
444402|NCT00503984|B3|Baseline|Total|Total of all reporting groups
444403|NCT00503984|B2|Baseline|Phase 2|All Phase 2 participants who received at least one dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
444404|NCT00503984|B1|Baseline|Phase 1|"All Phase 1 participants who received at least one dose of the combination of Azacitidine (Aza) and Docetaxel (Doc) and 5mg of Prednisone at one of the starting dose levels:~Level 1: 75 mg/m2 Aza + 60 mg/m2 Doc~Level 2: 75 mg/m2 Aza + 75 mg/m2 Doc~Level 3: 100 mg/m2 Aza + 75 mg/m2 Doc~Level 4: 150 mg/m2 Aza + 75 mg/m2 Doc"
444405|NCT00503984|P6|Participant Flow|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
444407|NCT00503984|P4|Participant Flow|Phase 1: Level 4 - 150 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 4 dose combination of 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5 mg of Prednisone.
444408|NCT00503984|P3|Participant Flow|Phase 1: Level 3 - 100 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 3 dose combination of 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
444409|NCT00503984|P2|Participant Flow|Phase 1: Level 2 - 75 Aza + 75 Doc|All Phase 1 participants who received at least one dose starting at the Level 2 dose combination of 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
444410|NCT00503984|P1|Participant Flow|Phase 1: Level 1 - 75 Aza + 60 Doc|All Phase 1 participants who received at least one dose starting at the Level 1 dose combination of 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) and 5mg of Prednisone.
444411|NCT00503984|O4|Outcome|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444412|NCT00503984|O3|Outcome|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444413|NCT00503984|O2|Outcome|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444414|NCT00503984|O1|Outcome|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
444415|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
444416|NCT00503984|O1|Outcome|All Study Participants|All study participants who received at least one dose of combination Azacitidine + Docetaxel, and 5 mg of Prednisone in either Phase 1 or Phase 2.
444417|NCT00503984|O1|Outcome|All Study Participants Achieving PSA Response|All study participants who achieved PSA response to protocol therapy. PSA response according to PCWG1 is defined as an least 50 percent decline in PSA level from baseline that was maintained for at least three weeks.
444418|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Initial Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
444419|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 4: 150 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444420|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444421|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m2 of Azacitidine (Aza), 75 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444422|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m2 of Azacitidine (Aza), 60 mg/m2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444423|NCT00503984|O6|Outcome|Phase 2 - Aza + Doc Reduced RPTD|All Phase 2 participants who received at least one reduced dose of the combination of Azacitidine and Docetaxel with 5 mg of Prednisone at the recommended phase two dose level (RPTD).
444424|NCT00503984|O5|Outcome|Phase 2 - Aza + Doc Initial RPTD|Recommended Phase Two Dose (RPTD) of Azacitidine and Docetaxel; and Prednisone; with optional growth factor support (pegfilgrastim/filgrastim).
444425|NCT00503984|O4|Outcome|Phase 1: Level 4 - 150 Aza + 75 Doc|Phase 1, Starting Dose Level 1: 150 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444426|NCT00503984|O3|Outcome|Phase 1: Level 3 - 100 Aza + 75 Doc|Phase 1, Starting Dose Level 3: 100 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444427|NCT00503984|O2|Outcome|Phase 1: Level 2 - 75 Aza + 75 Doc|Phase 1, Starting Dose Level 2: 75 mg/m^2 of Azacitidine (Aza), 75 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444428|NCT00503984|O1|Outcome|Phase 1: Level 1 - 75 Aza + 60 Doc|Phase 1, Starting Dose Level 1: 75 mg/m^2 of Azacitidine (Aza), 60 mg/m^2 of Docetaxel (Doc) with dose escalation/de-escalation design, and 5 mg of Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim)
444429|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
444430|NCT00503984|O1|Outcome|Phase 1 - Aza + Doc|Phase 1 Azacitidine (Aza) and Docetaxel (Doc) with dose escalation/de-escalation design, and Prednisone, with growth factor support; GADD45α methylation and expression analysis, with optional growth factor support (pegfilgrastim/filgrastim).
444431|NCT00503984|E4|Reported Event|Level 4 - 150 Aza + 75 Doc|150 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444432|NCT00503984|E3|Reported Event|Level 3 - 100 Aza + 75 Doc|100 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444433|NCT00503984|E2|Reported Event|Level 2 - 75 Aza + 75 Doc|75 mg/m2 of Azacitidine (Aza) and 75 mg/m2 of Docetaxel (Doc)
444434|NCT00503984|E1|Reported Event|Level 1 - 75 Aza + 60 Doc|75 mg/m2 of Azacitidine (Aza) and 60 mg/m2 of Docetaxel (Doc)
444435|NCT00503906|B1|Baseline|Single Arm|This is a single arm study
444436|NCT00503906|P1|Participant Flow|Abraxane, Bevacizumab and Gemcitabine|This is a single arm study
444437|NCT00503906|O1|Outcome|Abraxane, Bevacizumab and Gemcitabine|This is a single arm study
444445|NCT00507130|B3|Baseline|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444446|NCT00507130|B2|Baseline|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444447|NCT00507130|B1|Baseline|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444448|NCT00507130|P4|Participant Flow|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444449|NCT00507130|P3|Participant Flow|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444450|NCT00507130|P2|Participant Flow|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444451|NCT00507130|P1|Participant Flow|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444452|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444453|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444454|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444455|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444456|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444457|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444458|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444459|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444460|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444461|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444462|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444463|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444464|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444465|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444466|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444467|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444468|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444469|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444470|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444471|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444472|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444473|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444474|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444475|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444476|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444477|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444478|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444479|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444480|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444481|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444482|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444483|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444484|NCT00507130|O4|Outcome|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444485|NCT00507130|O3|Outcome|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444486|NCT00507130|O2|Outcome|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444487|NCT00507130|O1|Outcome|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444488|NCT00507130|E4|Reported Event|MEDI528 3 mg/kg|MEDI-528 at a dose of 3 mg/kg administered twice weekly as a SC dose for 4 weeks
444489|NCT00507130|E3|Reported Event|MEDI528 1 mg/kg|MEDI-528 at a dose of 1 mg/kg administered twice weekly as a SC dose for 4 weeks
444490|NCT00507130|E2|Reported Event|MEDI528 0.3 mg/kg|MEDI-528 at a dose of 0.3 mg/kg administered twice weekly as a SC dose for 4 weeks
444491|NCT00507130|E1|Reported Event|PLACEBO|Placebo administered twice weekly as a subcutaneous (SC) dose for 4 weeks
444492|NCT00506948|B1|Baseline|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
444493|NCT00506948|P1|Participant Flow|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
444533|NCT00506831|O1|Outcome|Imatinib Mesylate|All patients were treated with imatinib mesylate at a mean dosage of 300 mg daily.
444494|NCT00506948|O1|Outcome|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
444495|NCT00506948|E1|Reported Event|Thymoglobulin + Sirolimus + MMF|Thymoglobulin 1.5 mg/kg intravenous (IV) days -4, -3, -2, -1 before Stem Cell Transplant (Day 0); Sirolimus 6 mg IV on day -2 followed by 2 mg daily to maintain therapeutic levels and Mycophenolate Mofetil (MMF) 15 mg/kg IV or orally every 12 hours starting on day 0 until day+27.
444496|NCT00506922|B6|Baseline|Total|Total of all reporting groups
444497|NCT00506922|B5|Baseline|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
444498|NCT00506922|B4|Baseline|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
444499|NCT00506922|B3|Baseline|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
444500|NCT00506922|B2|Baseline|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
444501|NCT00506922|B1|Baseline|No Pentostatin|Group 1: No Pentostatin
444502|NCT00506922|P5|Participant Flow|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
444503|NCT00506922|P4|Participant Flow|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
444504|NCT00506922|P3|Participant Flow|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
444505|NCT00506922|P2|Participant Flow|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
444506|NCT00506922|P1|Participant Flow|No Pentostatin|Group 1: No Pentostatin
444507|NCT00506922|O1|Outcome|Pentostatin|150 patients were enrolled, 2 patients not treated, 38 patients were Group 1 (no Pentostatin), the remaining Groups 2,3,4 and 5, 110 patients were analysed that received the Pentostatin.
444508|NCT00506922|E5|Reported Event|Pentostatin 2|Group 5: Pentostatin 2 mg/m^2
444509|NCT00506922|E4|Reported Event|Pentostatin 1.5|Group 4: Pentostatin 1.5 mg/m^2
444510|NCT00506922|E3|Reported Event|Pentostatin 1|Group 3: Pentostatin 1 mg/m^2
444511|NCT00506922|E2|Reported Event|Pentostatin 0.5|Group 2: Pentostatin 0.5 mg/m^2
444512|NCT00506922|E1|Reported Event|No Pentostatin|Group 1: No Pentostatin
444513|NCT00506883|B4|Baseline|Total|Total of all reporting groups
444514|NCT00506883|B3|Baseline|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
444515|NCT00506883|B2|Baseline|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
444516|NCT00506883|B1|Baseline|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
444517|NCT00506883|P3|Participant Flow|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
444518|NCT00506883|P2|Participant Flow|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
444519|NCT00506883|P1|Participant Flow|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
444520|NCT00506883|O3|Outcome|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
444521|NCT00506883|O2|Outcome|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
444522|NCT00506883|O1|Outcome|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
444523|NCT00506883|E3|Reported Event|Placebo|Two oral placebo capsules at onset of a confirmed gout flare followed by 1 oral placebo capsule every hour for an additional 6 hours.
444524|NCT00506883|E2|Reported Event|Low Dose Colchicine(MPC-004)|Low Dose Colchicine - 1.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) after 1 hours followed by placebo every hour thereafter hourly for 5 additional hours. All active doses were over encapsulated to mimic the appearance of the placebo.
444525|NCT00506883|E1|Reported Event|High Dose Colchicine(MPC-004)|Standard Dose Colchicine - 4.8 mg (total dose): 1.2 mg of oral colchicine (2 x 0.6 mg tablets) at onset of confirmed gout flare followed by 0.6 mg oral colchicine (1 x 0.6 mg tablet) every hour for 6 hours. All doses were over encapsulated to mimic the appearance of the placebo.
444526|NCT00506857|B1|Baseline|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
444527|NCT00506857|P1|Participant Flow|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
444528|NCT00506857|O1|Outcome|Tacrolimus + Methotrexate|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
444529|NCT00506857|O1|Outcome|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
444530|NCT00506857|E1|Reported Event|Busulfan + Fludarabine|Busulfan starting 0.8 mg/kg by vein (IV) every 6 hours for 12 doses; Fludarabine 30 mg/m^2 IV daily for 4 days.
444531|NCT00506831|B1|Baseline|Imatinib Mesylate|
444532|NCT00506831|P1|Participant Flow|Imatinib Mesylate|
444540|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis after four weeks of cane use
444541|NCT00506714|O1|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking with a cane at baseline
444542|NCT00506714|O2|Outcome|Group 2|Adults with symptomatic hip osteoarthritis walking without a cane at baseline
444543|NCT00506714|O1|Outcome|Group 1|Healthy adults walking without a cane at baseline
444544|NCT00506714|E2|Reported Event|Group 2|Adults with symptomatic hip osteoarthritis
444545|NCT00506714|E1|Reported Event|Group 1|Healthy adults
444546|NCT00506675|B3|Baseline|Total|Total of all reporting groups
444547|NCT00506675|B2|Baseline|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444548|NCT00506675|B1|Baseline|Intensive|6 hours daily patching combined with daily atropine
444549|NCT00506675|P2|Participant Flow|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444550|NCT00506675|P1|Participant Flow|Intensive|6 hours daily patching combined with daily atropine
444551|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444552|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
444553|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444554|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
444555|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444556|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
444557|NCT00506675|O2|Outcome|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444558|NCT00506675|O1|Outcome|Intensive|6 hours daily patching combined with daily atropine
444559|NCT00506675|E2|Reported Event|Weaning|For patients currently patching, a reduction of current treatment for 4 weeks with 2 hours daily patching or once weekly atropine followed by spectacles alone if needed.
444560|NCT00506675|E1|Reported Event|Intensive|6 hours daily patching combined with daily atropine
444561|NCT00506662|B3|Baseline|Total|Total of all reporting groups
444562|NCT00506662|B2|Baseline|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444563|NCT00506662|B1|Baseline|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444564|NCT00506662|P2|Participant Flow|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444565|NCT00506662|P1|Participant Flow|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444566|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444567|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444568|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444569|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444570|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444571|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444572|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444573|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444574|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444575|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444576|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444577|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444578|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444579|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444580|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444581|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444582|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444583|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444584|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444585|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444586|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444587|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444588|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444589|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444590|NCT00506662|O2|Outcome|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444591|NCT00506662|O1|Outcome|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444592|NCT00506662|E2|Reported Event|Insulin NPH|Individually adjusted dose of insulin NPH once daily
444593|NCT00506662|E1|Reported Event|Insulin Detemir|Individually adjusted dose of insulin detemir once daily
444594|NCT00506597|B1|Baseline|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
444595|NCT00506597|P1|Participant Flow|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
444596|NCT00506597|O1|Outcome|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
444597|NCT00506597|E1|Reported Event|Erwinase|6 doses of 25,000 Units/m^2 Erwinase® intramuscular/subcutaneously every other day to replace each dose of Pegylated Asparaginase
444598|NCT00506493|B1|Baseline|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
444599|NCT00506493|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
444600|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
444601|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated with the Cardioblate Surgical Ablation System.. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
444602|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who underwent surgical ablation with the Cardioblate Surgical Ablation System.
444603|NCT00506493|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who underwent surgical ablation with the Cardioblate Surgical Ablation system and completed a Holter assessment at 9 month follow-up
444604|NCT00506493|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 64 subjects completed the study through the 9 month follow-up. 6 subjects died and 5 subjects withdrew from the study.
444605|NCT00506454|B3|Baseline|Total|Total of all reporting groups
444606|NCT00506454|B2|Baseline|Placebo|Participants receiving the placebo.
444607|NCT00506454|B1|Baseline|Active|Participants receiving the active drug.
444608|NCT00506454|P2|Participant Flow|Placebo|Participants receiving the placebo.
444609|NCT00506454|P1|Participant Flow|Active|Participants receiving the active drug.
444610|NCT00506454|O2|Outcome|Placebo|Participants receiving the placebo.
444611|NCT00506454|O1|Outcome|Treatment|Participants receiving the active drug.
444612|NCT00506454|E2|Reported Event|Placebo|Participants receiving the placebo.
444613|NCT00506454|E1|Reported Event|Active|Participants receiving the active drug.
444614|NCT00506441|B1|Baseline|MCI-196|"Open-label Period (Week 0 - 12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
444615|NCT00506441|P2|Participant Flow|Placebo|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
444616|NCT00506441|P1|Participant Flow|MCI-196|"Open-label Period (Week 0 -12) ; 3, 6, 9, 12, or 15 g/ day as titrated~Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period"
444617|NCT00506441|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated (Week 0 -12)
444618|NCT00506441|O2|Outcome|Placebo (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
444619|NCT00506441|O1|Outcome|MCI-196 (Double-blind Period)|Double-blind Period (Week 12 - 16) ; dose level at the end of dose titration in the Open-label period
444620|NCT00506441|E3|Reported Event|Placebo (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
444621|NCT00506441|E2|Reported Event|MCI-196 (Double-blind Period)|"dose level at the end of dose titration in the Open-label period (Week 12-16)~One subject who was randomized to placebo and another subject who was randomized to MCI-196 took both placebo and MCI-196 during the double-blind period. They have therefore been included in the MCI-196 group for the safety evaluation for the double-blind period."
444622|NCT00506441|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15 g/ day as titrated (Week 0-12)
444623|NCT00506415|B1|Baseline|Total Patients|Total number of patients enrolled in the initial open label period that may have been randomized in the double blind period or may have continued in the extended open label period.
444624|NCT00506415|P4|Participant Flow|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks (from week 48 to week 96) open label treatment.
444625|NCT00506415|P3|Participant Flow|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444626|NCT00506415|P2|Participant Flow|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444627|NCT00506415|P1|Participant Flow|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
444628|NCT00506415|O4|Outcome|Extended Open Label (10 cm^2)|Rivastigmine 10 cm^2 transdermal patch once a day during 48 weeks open label treatment running in parallel to the double blind period.
444629|NCT00506415|O3|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15c m^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444630|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444631|NCT00506415|O1|Outcome|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Rivastigmine 5 cm^2 transdermal patch once a day during the first 4 weeks of open label treatment followed by rivastigmine 10 cm^2 transdermal patch once a day from week 4 to week 24, 36 or 48.
444632|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444633|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444634|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444635|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during the double blind period.
444636|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444637|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444638|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444639|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444640|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444641|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444642|NCT00506415|O2|Outcome|Double Blind: Rivastigmine (15 cm^2)|Rivastigmine transdermal patch 15 cm^2 and placebo to rivastigmine 10 cm^2 once daily for 48 weeks during double blind period.
444643|NCT00506415|O1|Outcome|Double Blind: Rivastigmine (10 cm^2)|Rivastigmine transdermal patch 10 cm^2 and placebo to rivastigmine 15 cm^2 once daily for 48 weeks during the double blind period.
444644|NCT00506415|E4|Reported Event|Extended Open Label: Rivastigmine (10 cm^2)|Safety population Extended Open Label (Safety-EOL) - This population consisted of all patients who received at least 1 dose of study drug during the extended open label phase and had at least 1 post baseline safety assessment during the same phase.
444645|NCT00506415|E3|Reported Event|Double Blind: Rivastigmine (15 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
444646|NCT00506415|E2|Reported Event|Double Blind: Rivastigmine (10 cm^2)|Safety population Double Blind (Safety-DB) - This population included all patients who were randomized, received at least 1 dose of study drug during the double blind phase and had at least 1 post-randomization safety assessment during the double blind phase. Patients were analyzed according to treatment received.
444647|NCT00506415|E1|Reported Event|Initial Open Label: Rivastigmine (5 cm^2 / 10 cm^2)|Safety population Initial Open Label (Safety-IOL) - This population consisted of all patients who received at least 1 dose of study drug during the initial open label phase and had at least 1 post baseline safety assessment during the same phase.
444648|NCT00506389|B4|Baseline|Total|Total of all reporting groups
444649|NCT00506389|B3|Baseline|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444650|NCT00506389|B2|Baseline|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444651|NCT00506389|B1|Baseline|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444652|NCT00506389|P3|Participant Flow|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444653|NCT00506389|P2|Participant Flow|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444654|NCT00506389|P1|Participant Flow|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444655|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444656|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444657|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444658|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444659|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444660|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444661|NCT00506389|O3|Outcome|Placebo|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444662|NCT00506389|O2|Outcome|Esmirtazapine 4.5 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444663|NCT00506389|O1|Outcome|Esmirtazapine 3.0 mg|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. After this, participants were followed for safety up to Day 50 during the Follow-Up Period.
444664|NCT00506389|E6|Reported Event|Placebo Follow-up|After participants received placebo tablets during the Placebo Washout Period and placebo during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
444665|NCT00506389|E5|Reported Event|Esmirtazapine 4.5 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 4.5 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
444666|NCT00506389|E4|Reported Event|Esmirtazapine 3.0 mg Follow-up|After participants received placebo tablets during the Placebo Washout Period and 3.0 mg esmirtazapine during the In-treatment Period, participants were followed for safety up to Day 50 during the Follow-up Period.
444667|NCT00506389|E3|Reported Event|Placebo In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, placebo tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
444668|NCT00506389|E2|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 4.5 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
444669|NCT00506389|E1|Reported Event|Esmirtazapine 3.0 mg In-treatment|Participants took placebo tablets during the 10- to 14-day Placebo Washout Period, esmirtazapine 3.0 mg tablets during the 6-week In-treatment Period, and placebo tablets during the 1-week Placebo Withdrawal Period. Tablets were taken by mouth once daily in the evening.
444670|NCT00506285|B3|Baseline|Total|Total of all reporting groups
444671|NCT00506285|B2|Baseline|B Placebo Patch Was Used First|Placebo patch was used in the first treatment arm and MTS in the second treatment arm.
444672|NCT00506285|B1|Baseline|a) Methylphenidate Transdermal System Was Taken First|Subjects took Methylphenidate Transdermal System in the first treatment arm and placebo patch in the second treatment arm
444673|NCT00506285|P2|Participant Flow|B) PBO Arm Was 1st and MTS Arm Was 2nd|Placebo was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 MTS patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
444674|NCT00506285|P1|Participant Flow|A) MTS Arm Was 1st and PBO Arm Was 2nd|MTS was initiated using a 12.5cm2 patch then increased to the highest possible tolerated dose within two weeks and held at that level for the final two weeks of the first 4-week arm. In the second double-blind arm subjects were started using a 12.5cm2 placebo patch, which was increased to the highest tolerated dose within two weeks and held at that level for the final two weeks of the second 4-week arm.
444675|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average CAARS score at end of placebo treatment
444676|NCT00506285|O1|Outcome|Scores in MTS Arm|Average CAARS score at end of active treatment
444677|NCT00506285|O2|Outcome|Scores in Placebo Arm|Average WRAADDS scores at end of placebo arm
444678|NCT00506285|O1|Outcome|Scores in MTS Arm|Average WRAADDS scores at end of active treatment (MTS) arm
444679|NCT00506285|E2|Reported Event|Placebo Arm|Adverse events and Serious AEs during placebo arm
444680|NCT00506285|E1|Reported Event|MTS Arm|Adverse events and Serious AEs during active treatment (MTS) arm
444681|NCT00506155|B1|Baseline|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
444682|NCT00506155|P1|Participant Flow|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
444683|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
444684|NCT00506155|O1|Outcome|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
444685|NCT00506155|E1|Reported Event|Neoadjuvant Chemotherapy With M-VAC + Avastin|Avastin 10 mg/kg intravenous (IV) over 90 minutes. Cisplatin 70 mg/m^2 IV over 4 hours. Doxorubicin 30 mg/m^2 IV over 15 minutes. Methotrexate 30 mg/m^2 IV over 30 minutes. Vinblastine Sulfate 3 mg/m^2 IV over 30 minutes.
444686|NCT00506077|B3|Baseline|Total|Total of all reporting groups
444687|NCT00506077|B2|Baseline|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
444688|NCT00506077|B1|Baseline|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
444689|NCT00506077|P2|Participant Flow|Placebo Then MK0249|These subjects received Placebo during Treatment Period 1 and MK0249 during Treatment Period 2.
444690|NCT00506077|P1|Participant Flow|MK0249 Then Placebo|These subjects received MK0249 during Treatment Period 1 and Placebo during Treatment Period 2.
444691|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444692|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444693|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444694|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444695|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444696|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444697|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444698|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444699|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444700|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444701|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444702|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444703|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444704|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444705|NCT00506077|O2|Outcome|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444706|NCT00506077|O1|Outcome|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444707|NCT00506077|E2|Reported Event|Placebo|10 mg per day of matching placebo were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444708|NCT00506077|E1|Reported Event|MK0249|10 mg per day of MK-0249 were taken orally for Treatment Period 1 or Treatment Period 2 (depending on the sequence). At any time after 3 days of double-blind treatment if patients who were unable to tolerate 10 mg per day, they were allowed to titrate down to 7 mg per day and remained on 7 mg per day for the remainder of the treatment period.
444709|NCT00506064|B3|Baseline|Total|Total of all reporting groups
444710|NCT00506064|B2|Baseline|Placebo|Starch capsules by mouth daily
444711|NCT00506064|B1|Baseline|Melatonin|0.15 mg/kg capsules by mouth daily
444712|NCT00506064|P2|Participant Flow|Placebo|Starch capsules by mouth daily
444720|NCT00506025|B2|Baseline|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
444721|NCT00506025|B1|Baseline|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
444722|NCT00506025|P3|Participant Flow|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
444723|NCT00506025|P2|Participant Flow|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
444724|NCT00506025|P1|Participant Flow|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
444725|NCT00506025|O3|Outcome|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
444726|NCT00506025|O2|Outcome|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
444727|NCT00506025|O1|Outcome|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
444728|NCT00506025|E3|Reported Event|Placebo 2xday|Placebo two times daily (P, P; n = 8 pregnant)
444729|NCT00506025|E2|Reported Event|Cranberry + Placebo|Cranberry in the a.m., then placebo (P) in the p.m. (C, P; n = 9 pregnant)
444730|NCT00506025|E1|Reported Event|Cranberry 2xday|Cranberry (C) two times daily (C, C; n = 10 pregnant)
444731|NCT00505934|B1|Baseline|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444732|NCT00505934|P1|Participant Flow|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444733|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444734|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444735|NCT00505934|O1|Outcome|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444736|NCT00505934|E1|Reported Event|Levetiracetam|"Intravenous 100 mg/mL, twice a day, maximum of 4 days~Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose within the following dose range, calculated on the basis of their age and weight:.~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily) to 42 mg/kg/day (21 mg/kg/day twice daily);~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily) to 60 mg/kg/day (30 mg/kg/day twice daily).~For subjects not taking levetiracetam oral solution prior to entering the study, the intravenous (IV) dosage corresponded to their age and weight as follows:~Ages ≥ 1 month to < 6 months: 14 mg/kg/day (7 mg/kg twice daily).~Ages ≥ 6 months to < 4 years: 20 mg/kg/day (10 mg/kg twice daily)."
444737|NCT00505921|B1|Baseline|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
444767|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444768|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444769|NCT00505778|E2|Reported Event|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444770|NCT00505778|E1|Reported Event|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444738|NCT00505921|P1|Participant Flow|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
444739|NCT00505921|O1|Outcome|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
444740|NCT00505921|E1|Reported Event|Campath-1H|"3 mg in vivo Day 1; 10 mg Day 2; 30 mg Days 3 and 10 of chemotherapy treatment. Transplantation on Day 0.~Preparative Regimen For Autologous Stem Cell Transplantation: BEAM (BCNU 300 mg/m2 intravenous (IV) over 1 hour on day -6, cytarabine 200 mg/m2 IV twice a day on day -5 through -2 (total 8 doses), etoposide 200 mg/m2 IV twice on day -5 to -2 (total 8 doses), and Melphalan 140 mg/m2 IV on day -1. Beginning on day +5 G-CSF 10 mg/kg sc (in a.m.) and GM-SCF 250 m/m2 on Day +5 (in p.m.)~Preparative Regimen For Allogenic Stem Cell Transplantation: Campath 15mg/day (days -6 to -4), fludarabine 30 mg/m2 IV/day (days -6 to -4) and cyclophosphamide 750 mg/m2 IV/day (1000 mg/m2 IV/day if unrelated) (days -6 to -4). Low dose total body irradiation of 2 Gy day 0."
444741|NCT00505895|B3|Baseline|Total|Total of all reporting groups
444742|NCT00505895|B2|Baseline|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 intravenous over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 intravenous infused starting on day -5."
444743|NCT00505895|B1|Baseline|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444744|NCT00505895|P2|Participant Flow|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444745|NCT00505895|P1|Participant Flow|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444746|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444747|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444748|NCT00505895|O2|Outcome|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444749|NCT00505895|O1|Outcome|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444750|NCT00505895|E2|Reported Event|Fludarabine + Lower-Dose Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 IV daily over 30 minutes for 4 Days (Beginning Day -4).~Lower-Dose Melphalan 100 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444751|NCT00505895|E1|Reported Event|Fludarabine + Melphalan + Stem Cell Infusion|"Fludarabine 30 mg/m^2 intravenous (IV) daily over 30 minutes for 4 Days (Beginning Day -4).~Melphalan 140 mg/m^2 IV over 20 minutes on Day -1. Stem Cell Infusion on Day 0. Rituximab 375 mg/m^2 IV infused starting on day -5."
444752|NCT00505778|B3|Baseline|Total|Total of all reporting groups
444753|NCT00505778|B2|Baseline|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444754|NCT00505778|B1|Baseline|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444755|NCT00505778|P2|Participant Flow|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444756|NCT00505778|P1|Participant Flow|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444757|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444758|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444759|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444760|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444761|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444762|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444763|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444764|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444765|NCT00505778|O2|Outcome|Mesalamine Twice-Daily|an oral, twice daily (BID) mesalamine regimen (1.6 - 2.4 g/day)
444766|NCT00505778|O1|Outcome|Mesalamine Once-Daily|an oral, once daily (QD) mesalamine regimen (1.6 - 2.4 g/day)
444772|NCT00505765|B3|Baseline|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444773|NCT00505765|B2|Baseline|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444774|NCT00505765|B1|Baseline|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444775|NCT00505765|P3|Participant Flow|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444776|NCT00505765|P2|Participant Flow|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444777|NCT00505765|P1|Participant Flow|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444778|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444779|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444780|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444781|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444782|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444783|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444784|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444785|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444786|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444787|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444788|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444789|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444790|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444791|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444792|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444793|NCT00505765|O3|Outcome|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444794|NCT00505765|O2|Outcome|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444795|NCT00505765|O1|Outcome|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444796|NCT00505765|E3|Reported Event|Placebo|"Placebo, low-dose: 1 puff administered in each nostril daily (QD) Placebo, high-dose: 3 puffs administered twice daily in each nostril (BID)~Data were combined across placebo conditions for analysis"
444797|NCT00505765|E2|Reported Event|AL-108, 5 mg/Day|AL-108, 5 mg/day- one spray in each nostril once per day
444798|NCT00505765|E1|Reported Event|AL-108, 30 mg/Day|AL-108, 30 mg/day- 3 sprays in each nostril, twice per day
444799|NCT00505752|B5|Baseline|Total|Total of all reporting groups
444800|NCT00505752|B4|Baseline|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444801|NCT00505752|B3|Baseline|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444802|NCT00505752|B2|Baseline|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444803|NCT00505752|B1|Baseline|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444804|NCT00505752|P4|Participant Flow|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444805|NCT00505752|P3|Participant Flow|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444806|NCT00505752|P2|Participant Flow|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444807|NCT00505752|P1|Participant Flow|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444808|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444809|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444810|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444811|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444812|NCT00505752|O4|Outcome|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444813|NCT00505752|O3|Outcome|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444870|NCT00505414|O5|Outcome|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
445007|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
444814|NCT00505752|O2|Outcome|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444815|NCT00505752|O1|Outcome|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444816|NCT00505752|E4|Reported Event|Follitropin Alfa 150 IU|Follitropin alfa (Gonal-f®) 150 IU administered subcutaneously once daily from S1 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444817|NCT00505752|E3|Reported Event|AS900672-Enriched 150 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 150 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444818|NCT00505752|E2|Reported Event|AS900672-Enriched 100 Microgram (Mcg)|Single injection of AS900672-Enriched (hyperglycosylated r-hFSH), 100 mcg administered subcutaneously on S1 followed by a daily dose of follitropin alfa 150 IU subcutaneously starting from S6 up to S21 based upon ovarian response, until r-hCG administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of >= 18 mm, two or more additional follicles with a diameter of >= 16 mm, and E2 levels were approximately 150 pg/mL per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444819|NCT00505752|E1|Reported Event|AS900672-Enriched 50 Mcg|Single injection of AS900672-Enriched (hyperglycosylated recombinant human follicle stimulating hormone [r-hFSH]), 50 microgram (mcg) administered subcutaneously on Stimulation day 1 (S1) followed by a daily dose of follitropin alfa 150 international unit (IU) subcutaneously starting from Stimulation Day 6 (S6) up to Stimulation Day 21 (S21) based upon ovarian response, until recombinant human chorionic gonadotropin (r-hCG, Ovidrel®) administration day. When follicular response was adequate (that is, at least 1 follicle with a diameter of greater than or equal to [>=] 18 millimeter [mm], two or more additional follicles with a diameter of >= 16 mm, and Estradiol [E2] levels were approximately 150 picogram per milliliter [pg/mL] per mature follicle), ovulation was triggered by single 250 mcg subcutaneous r-hCG injection. Duration of treatment cycle was up to adequate follicular response or maximum of 21 days.
444820|NCT00505687|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444821|NCT00505687|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444822|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444823|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444824|NCT00505687|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444825|NCT00505687|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
444826|NCT00505661|B1|Baseline|Letrozole|2.5 mg by mouth (PO) daily
444827|NCT00505661|P1|Participant Flow|Letrozole|2.5 mg by mouth (PO) daily
444828|NCT00505661|O1|Outcome|Letrozole|2.5 mg by mouth (PO) daily
444829|NCT00505661|E1|Reported Event|Letrozole|2.5 mg by mouth (PO) daily
444830|NCT00505635|B1|Baseline|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
444831|NCT00505635|P1|Participant Flow|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
444832|NCT00505635|O1|Outcome|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
444833|NCT00505635|E1|Reported Event|Biochemotherapy With Temozolomide|Temozolomide 250 mg/m^2 every 4 hours Day 1; Biochemotherapy of Velban 1.5 mg/m^2 intravenous (IV) Days 1-4; Cisplatin 20 mg/m^2 IV Days 1-4; + Interleukin-2 9 MIU/m^2 IV over 24 Hours for 4 Doses Days 1-4; Intron-A 5 mu/m^2 subcutaneously daily Days 1-5; + Oral Thalidomide 400 mg daily.
444834|NCT00505622|B4|Baseline|Total|Total of all reporting groups
444835|NCT00505622|B3|Baseline|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444836|NCT00505622|B2|Baseline|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444837|NCT00505622|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444838|NCT00505622|P3|Participant Flow|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444839|NCT00505622|P2|Participant Flow|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444840|NCT00505622|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444841|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444842|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444843|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444844|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444845|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444846|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444847|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444848|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
445006|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
444849|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444850|NCT00505622|O3|Outcome|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444851|NCT00505622|O2|Outcome|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444852|NCT00505622|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444853|NCT00505622|E3|Reported Event|Perampanel (Perampanel 4mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444854|NCT00505622|E2|Reported Event|Perampanel (Entacapone 200mg During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444855|NCT00505622|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007-G000-309). Subjects started on perampanel 2mg once daily for 2 weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects who did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects who did not tolerate 2mg were withdrawn from the study.
444856|NCT00505518|B1|Baseline|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
444857|NCT00505518|P1|Participant Flow|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
444858|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
444859|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
444860|NCT00505518|O1|Outcome|Telepsychiatry|Telepsychiatry-based follow up visits with psychiatrist.
444861|NCT00505518|E1|Reported Event|Telepsychiatry Treatment|Patients in the telepsychiatry treatment group will videoconference the P.I. for regular psychiatric visits in addition to meeting with nursing home staff. Treatment suggestions will be provided to the patient's primary care physician to be implemented.
444862|NCT00505414|B3|Baseline|Total|Total of all reporting groups
444863|NCT00505414|B2|Baseline|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444864|NCT00505414|B1|Baseline|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444865|NCT00505414|P5|Participant Flow|Morphine (Titration Phase)|After signing informed consent eligible participants were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444866|NCT00505414|P4|Participant Flow|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg up to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444867|NCT00505414|P3|Participant Flow|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
444868|NCT00505414|P2|Participant Flow|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
444869|NCT00505414|P1|Participant Flow|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
453504|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
444871|NCT00505414|O4|Outcome|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444872|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
444873|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
444874|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
444875|NCT00505414|O3|Outcome|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
444876|NCT00505414|O2|Outcome|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
444877|NCT00505414|O1|Outcome|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
444878|NCT00505414|E5|Reported Event|Morphine (Titration Phase)|After signing informed consent eligible subjects were randomized to receive morphine controlled release. The oral medication was taken twice daily starting at 45 mg up to 90 mg twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444879|NCT00505414|E4|Reported Event|Tapentadol (Titration Phase)|After signing informed consent eligible participants were randomized to receive tapentadol extended release. Oral tapentadol 100 mg to 250 mg twice daily. The oral medication was taken twice daily, morning and evening every 12 hours (with a minimum of 6 hours between doses).
444880|NCT00505414|E3|Reported Event|Matching Placebo (Maintenance Phase)|Participants were re-randomized to placebo after being on tapentadol in the titration phase. At the start of this phase participants received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off of the tapentadol dose they had received in the titration period. From the fourth day of the maintenance period onwards they received placebo twice daily.
444881|NCT00505414|E2|Reported Event|Tapentadol (Maintenance Phase)|Participants re-randomized to tapentadol prolonged release in the maintenance phase continued on the dose level established at the end of the titration phase. Oral tapentadol 100 mg to 250 mg twice daily.
444882|NCT00505414|E1|Reported Event|Morphine (Maintenance Phase)|Participants in the maintenance phase continued on the dose level established in titration phase, i.e. 45 mg to 90 mg twice daily.
444883|NCT00505375|B3|Baseline|Total|Total of all reporting groups
444884|NCT00505375|B2|Baseline|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
444885|NCT00505375|B1|Baseline|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
444886|NCT00505375|P2|Participant Flow|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
444887|NCT00505375|P1|Participant Flow|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
444888|NCT00505375|O2|Outcome|Placebo|Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses
444889|NCT00505375|O1|Outcome|CTLA-4 Ig|Intravenous infusions 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses
444890|NCT00505375|E2|Reported Event|Placebo|"Intravenous infusions of placebo~Placebo: Intravenous infusions of placebo every other week for the first two doses and then every 28 days for a total of 27 doses"
444891|NCT00505375|E1|Reported Event|CTLA-4 Ig|"Intravenous infusions of CTLA-4 Ig~CTLA-4 Ig: Intravenous infusion of 10 mg/kg of CTLA-4 Ig every other week for the first two doses and then every 28 days for a total of 27 doses"
444892|NCT00505284|B6|Baseline|Total|Total of all reporting groups
444893|NCT00505284|B5|Baseline|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444894|NCT00505284|B4|Baseline|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444895|NCT00505284|B3|Baseline|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444896|NCT00505284|B2|Baseline|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444897|NCT00505284|B1|Baseline|Placebo|
444898|NCT00505284|P5|Participant Flow|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444899|NCT00505284|P4|Participant Flow|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444900|NCT00505284|P3|Participant Flow|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444901|NCT00505284|P2|Participant Flow|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444902|NCT00505284|P1|Participant Flow|Placebo|
444903|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444904|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444905|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444906|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444907|NCT00505284|O1|Outcome|Placebo|
444908|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444909|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444910|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444911|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444912|NCT00505284|O1|Outcome|Placebo|
444913|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444914|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444915|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444916|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444917|NCT00505284|O1|Outcome|Placebo|
444918|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444919|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444920|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444921|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444922|NCT00505284|O1|Outcome|Placebo|
444923|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444924|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444925|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444926|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444927|NCT00505284|O1|Outcome|Placebo|
444928|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444929|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444930|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444931|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444932|NCT00505284|O1|Outcome|Placebo|
444933|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444934|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444935|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444936|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444937|NCT00505284|O1|Outcome|Placebo|
444938|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444939|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444940|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444941|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444942|NCT00505284|O1|Outcome|Placebo|
444943|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444944|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444945|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444946|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444947|NCT00505284|O1|Outcome|Placebo|
444948|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444949|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444950|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444951|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444952|NCT00505284|O1|Outcome|Placebo|
444953|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444954|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444955|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444956|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444957|NCT00505284|O1|Outcome|Placebo|
444958|NCT00505284|O5|Outcome|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444959|NCT00505284|O4|Outcome|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444960|NCT00505284|O3|Outcome|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444961|NCT00505284|O2|Outcome|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444962|NCT00505284|O1|Outcome|Placebo|
444963|NCT00505284|E5|Reported Event|Perampanel 8mg|(Perampanel 2mg once daily for 3 weeks; then, perampanel 4mg once daily for 3 weeks; followed by perampanel 6mg once daily for 3 weeks; and finally, perampanel 8mg once daily for 6 weeks)
444964|NCT00505284|E4|Reported Event|Perampanel 6mg|(Perampanel 2mg once daily for 3 weeks; followed by perampanel 4mg once daily for 3 weeks; and finally, perampanel 6mg once daily for 9 weeks)
444965|NCT00505284|E3|Reported Event|Perampanel 4mg|(Perampanel 2mg once daily for 3 weeks, followed by perampanel 4mg once daily for 12 weeks)
444966|NCT00505284|E2|Reported Event|Perampanel 2mg|(Perampanel 2mg once daily for 15 weeks)
444967|NCT00505284|E1|Reported Event|Placebo|
444968|NCT00505076|B4|Baseline|Total|Total of all reporting groups
444969|NCT00505076|B3|Baseline|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
444970|NCT00505076|B2|Baseline|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
444971|NCT00505076|B1|Baseline|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
444972|NCT00505076|P3|Participant Flow|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
444973|NCT00505076|P2|Participant Flow|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
444974|NCT00505076|P1|Participant Flow|MK-0777 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
444975|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
444976|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
444977|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
444978|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
444979|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
444980|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
444981|NCT00505076|O3|Outcome|Placebo BID|Subjects treated with placebo tablet BID
444982|NCT00505076|O2|Outcome|MK-0777 3 mg BID|Subjects treated with MK-0777 , 3 mg BID
444983|NCT00505076|O1|Outcome|MK-077 8 mg BID|Subjects treated with MK-0777, 8 mg BID
444984|NCT00505076|E3|Reported Event|Placebo BID|Subjects treated with 2 tablets placebo BID (twice daily)
444985|NCT00505076|E2|Reported Event|MK-0777 3 mg BID|Subjects treated with MK-0777 GEM, 3 mg BID (twice daily)
444986|NCT00505076|E1|Reported Event|MK-077 8 mg BID|Subjects treated with MK-0777 GEM, 8 mg BID(twice daily)
444987|NCT00504985|B1|Baseline|Fatigue in Emergency Center Patients|
444988|NCT00504985|P1|Participant Flow|Fatigue in Emergency Center Patients|
444989|NCT00504985|O1|Outcome|Fatigue in Emergency Center Patients|
444990|NCT00504985|E1|Reported Event|Fatigue in Emergency Center Patients|
444991|NCT00504777|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV, and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444992|NCT00504777|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444993|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444994|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444995|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444996|NCT00504777|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444997|NCT00504777|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and 100 mg methylprednisolone IV on Days 1 and 15. Participants were to be receiving background MTX (10-25 mg weekly, oral or parenteral dose).
444998|NCT00504725|B3|Baseline|Total|Total of all reporting groups
444999|NCT00504725|B2|Baseline|Placebo|0.9 % saline bolus of equivalent volume
445000|NCT00504725|B1|Baseline|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
445001|NCT00504725|P2|Participant Flow|Placebo|0.9 % saline bolus of equivalent volume
445002|NCT00504725|P1|Participant Flow|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
445003|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
445004|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
445005|NCT00504725|O2|Outcome|Placebo|0.9 % saline bolus of equivalent volume
445008|NCT00504725|O1|Outcome|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
445009|NCT00504725|E2|Reported Event|Placebo|0.9 % saline bolus of equivalent volume
445010|NCT00504725|E1|Reported Event|Ketamine|Single bolus 0.5mg/kg ketamine IV after induction of anesthesia
445011|NCT00504660|B3|Baseline|Total|Total of all reporting groups
445012|NCT00504660|B2|Baseline|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
445013|NCT00504660|B1|Baseline|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
445014|NCT00504660|P2|Participant Flow|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
445015|NCT00504660|P1|Participant Flow|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
445016|NCT00504660|O1|Outcome|Participants With Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
445017|NCT00504660|O1|Outcome|Participants With Recurrent Anaplastic Glioma|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Capecitabine 825 mg/m^2 and Celebrex 400 mg PO every 12 hours; Arm 1 Temozolomide (TMZ) 150 mg/m^2 PO daily Days 4-8 OR Arm 2 Lomustine 100 mg/m^2 PO on Day 4; Arm 2 Participants if previously received Temozolomide but not Lomustine (CCNU) receive Lomustine; or if had Gliadel wafers and Temozolomide with radiotherapy (XRT) receive Temozolomide.
445018|NCT00504660|E2|Reported Event|Glioblastoma Multiforme|"6-TG 80 mg/m^2 PO every 6 Hours Day 1-3; Capecitabine 825 mg/m^2 PO every 12 hours Days 14-27 and Celebrex 400 mg PO every 12 hours Day 11-24; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR CCNU (Lomustine) 100 mg/m2 orally Day 4 of each 42-day cycle.~Participants receive Temozolomide if not had previous treatment and if had prior CCNU. Those previously treated with Temozolomide but not CCNU receive CCNU, and those that had Gliadel and Temozolomide with XRT receive Temozolomide."
445019|NCT00504660|E1|Reported Event|Anaplastic Tumors|6-TG 80 mg/m^2 orally (PO) every 6 hours Day 1-3; Temozolomide 150 mg/m^2 PO daily Days 4-8 OR Lomustine 100 mg/m^2 PO on Day 4; Capecitabine 825 mg/m^2 every 12 hours; and Celebrex 400 mg PO every 12 hours for 13 days for 28 day course.
445020|NCT00504595|B5|Baseline|Total|Total of all reporting groups
445021|NCT00504595|B4|Baseline|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
445022|NCT00504595|B3|Baseline|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445023|NCT00504595|B2|Baseline|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
445024|NCT00504595|B1|Baseline|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445025|NCT00504595|P4|Participant Flow|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
445026|NCT00504595|P3|Participant Flow|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445027|NCT00504595|P2|Participant Flow|ACZ885 (Canakinumab) : Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1
445028|NCT00504595|P1|Participant Flow|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445029|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445030|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445031|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Patients with Rheumatoid Arthritis (RA) who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445032|NCT00504595|O1|Outcome|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis (RA) taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445033|NCT00504595|O2|Outcome|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445034|NCT00504595|O1|Outcome|ACZ885 (Canakinumab) : RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445035|NCT00504595|E4|Reported Event|Placebo Comparator: RA Patients|Rheumatoid Arthritis patients who received placebo Intravenous (IV) on Day 1, Day 15 and Day 43.
445036|NCT00504595|E3|Reported Event|ACZ885 (Canakinumab): RA Patients|Patients with Rheumatoid Arthritis RA taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1, Day 15, and Day 43.
445037|NCT00504595|E2|Reported Event|Placebo Comparator: Healthy Volunteers|Healthy Volunteers who received placebo Intravenous (IV) at Day 1.
445038|NCT00504595|E1|Reported Event|ACZ885 (Canakinumab): Healthy Volunteers|Healthy Volunteers taking 600 mg of ACZ885 (Canakinumab) Intravenous (IV) on Day 1.
445039|NCT00504556|B6|Baseline|Total|Total of all reporting groups
445040|NCT00504556|B5|Baseline|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445041|NCT00504556|B4|Baseline|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445042|NCT00504556|B3|Baseline|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445043|NCT00504556|B2|Baseline|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445044|NCT00504556|B1|Baseline|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445045|NCT00504556|P5|Participant Flow|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445046|NCT00504556|P4|Participant Flow|DU-176b 60mg Bid|"DU-176b 60mg tablets two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445047|NCT00504556|P3|Participant Flow|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445048|NCT00504556|P2|Participant Flow|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445049|NCT00504556|P1|Participant Flow|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445050|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445051|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445052|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445053|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445054|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445055|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445056|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445057|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445058|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445059|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445060|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445061|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445062|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445063|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445064|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445065|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445066|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445067|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445068|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445069|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445070|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445071|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445072|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445073|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445074|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445075|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445076|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445077|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445078|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445079|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445080|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445081|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445082|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445083|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445084|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445085|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445086|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445087|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445088|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445089|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445090|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445091|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445092|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445093|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445094|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445095|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445096|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445097|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445098|NCT00504556|O5|Outcome|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445099|NCT00504556|O4|Outcome|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445100|NCT00504556|O3|Outcome|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445101|NCT00504556|O2|Outcome|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445102|NCT00504556|O1|Outcome|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445103|NCT00504556|E5|Reported Event|Warfarin Tablets|"warfarin tablets~warfarin: warfarin tablets"
445104|NCT00504556|E4|Reported Event|DU-176b 60mg Bid|"DU-176b 60mg tablet two times a day~Edoxaban (DU-176b): 60mg tablet two times a day"
445105|NCT00504556|E3|Reported Event|DU-176b 60mg qd|"DU-176b 60mg once daily (qd)~Edoxaban (DU-176b): 60mg tablet once daily"
445106|NCT00504556|E2|Reported Event|DU-176b 30mg Bid|"DU-176b 30mg twice daily (bid)~Edoxaban (DU-176b): 30mg tablet twice daily"
445107|NCT00504556|E1|Reported Event|DU-176b 30mg qd|"DU-176b 30mg tablet once daily (qd)~Edoxaban (DU-176b): 30mg tablet once daily"
445108|NCT00504504|B1|Baseline|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
445109|NCT00504504|P1|Participant Flow|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
445110|NCT00504504|O1|Outcome|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
445111|NCT00504504|E1|Reported Event|Rituximab + ABVD Chemotherapy|Rituximab 375 mg/m^2 by vein (IV) over 3 to 8 hours weekly for 6 weeks in a row. ABVD Chemo: Adriamycin 25 mg/m^2 IV, Bleomycin 10 U/m^2 IV, Vinblastine 6 mg/m^2 IV, DTIC 375 mg/m^2 IV. Each but Rituximab over 3 hours every other week for a total of 12 treatments.
445112|NCT00504426|B5|Baseline|Total|Total of all reporting groups
445113|NCT00504426|B4|Baseline|OPC-249 (120IU)|120 IU of OPC-249/vial
445114|NCT00504426|B3|Baseline|OPC-249 (60IU)|60 IU of OPC-249/vial
445115|NCT00504426|B2|Baseline|OPC-249 (30IU)|30 IU of OPC-249/vial
445116|NCT00504426|B1|Baseline|Placebo|Placebo of OPC-249/vial
445117|NCT00504426|P4|Participant Flow|OPC-249 (120IU)|120 IU of OPC-249/vial
445118|NCT00504426|P3|Participant Flow|OPC-249 (60IU)|60 IU of OPC-249/vial
445119|NCT00504426|P2|Participant Flow|OPC-249 (30IU)|30 IU of OPC-249/vial
445120|NCT00504426|P1|Participant Flow|Placebo|Placebo of OPC-249/vial
445121|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249/vial
445122|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249/vial
445123|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249/vial
445124|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
445125|NCT00504426|O4|Outcome|OPC-249 (120IU)|120 IU of OPC-249 /vial
445126|NCT00504426|O3|Outcome|OPC-249 (60IU)|60 IU of OPC-249 /vial
445127|NCT00504426|O2|Outcome|OPC-249 (30IU)|30 IU of OPC-249 /vial
445128|NCT00504426|O1|Outcome|Placebo|Placebo of OPC-249/vial
445129|NCT00504426|E4|Reported Event|OPC-249 (120IU)|120 IU of OPC-249/vial
445130|NCT00504426|E3|Reported Event|OPC-249 (60IU)|60 IU of OPC-249/vial
445131|NCT00504426|E2|Reported Event|OPC-249 (30IU)|30 IU of OPC-249/vial
445132|NCT00504426|E1|Reported Event|Placebo|Placebo of OPC-249/vial
445133|NCT00504257|B1|Baseline|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445134|NCT00504257|P1|Participant Flow|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445135|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445136|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445179|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445210|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445137|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445138|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445139|NCT00504257|O1|Outcome|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445140|NCT00504257|E1|Reported Event|Avastin and Docetaxel|Combination Therapy: Immunotherapy (Avastin) and Chemotherapy (Docetaxel) as outlined in Intervention descriptions. Avastin: 15 mg/kg, In 100 ml normal saline (NS) IV infusion over 90 +/- 15 minutes, Day 1, every 21 day cycle. Docetaxel: 40 mg/m^2, In 250 ml 5% dextrose in pure water (D5W) or NS IV infusion over 1 hour in a non-pvc container and through a polyethylene-lined set, Day 1, 8, every 21 day cycle. Response assessment every 3 cycles (9 weeks).
445141|NCT00504231|B5|Baseline|Total|Total of all reporting groups
445142|NCT00504231|B4|Baseline|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
445143|NCT00504231|B3|Baseline|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
445144|NCT00504231|B2|Baseline|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
445145|NCT00504231|B1|Baseline|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
445146|NCT00504231|P4|Participant Flow|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
445147|NCT00504231|P3|Participant Flow|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
445148|NCT00504231|P2|Participant Flow|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
445149|NCT00504231|P1|Participant Flow|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
445150|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
445151|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
445152|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
445153|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
445154|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
445155|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
445156|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
445157|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
445158|NCT00504231|O4|Outcome|60% Dose 0.15 mL x 2 ID|60% dose - 0.15 mL delivered twice intradermally with needle and syringe
445159|NCT00504231|O3|Outcome|60% Dose 0.3 mL ID|60% dose - 0.3 mL delivered intradermally with needle and syringe
445160|NCT00504231|O2|Outcome|60% Dose 0.3 mL IM|60% dose - 0.3 mL delivered intramuscularly with needle and syringe
445161|NCT00504231|O1|Outcome|Full-dose 0.5 mL IM|100% dose - 0.5mL delivered intramuscularly with needle and syringe
445162|NCT00504231|E4|Reported Event|60% Dose 0.15 mL x 2 ID|0.15 mL influenza vaccine twice delivered intradermally with needle and syringe
445163|NCT00504231|E3|Reported Event|60% Dose 0.3 mL ID|0.3 mL influenza vaccine delivered intradermally
445164|NCT00504231|E2|Reported Event|60% Dose 0.3 mL IM|0.3 mL influenza vaccine delivered intramuscularly with needle/syringe
445165|NCT00504231|E1|Reported Event|Full-dose 0.5 mL IM|0.5 mL influenza vaccine delivered intramuscularly with needle/syringe
445166|NCT00504166|B3|Baseline|Total|Total of all reporting groups
445167|NCT00504166|B2|Baseline|Placebo|placebo to match alendronate sodium
445168|NCT00504166|B1|Baseline|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
445169|NCT00504166|P2|Participant Flow|Placebo|placebo to match alendronate sodium
445170|NCT00504166|P1|Participant Flow|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
445171|NCT00504166|O2|Outcome|Placebo Treatment|daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
445172|NCT00504166|O1|Outcome|Alendronate Treatment|70 mg of alendronate once weekly and daily 2800 IU of vitamin D3 and OSCal + D (1000 mg of calcium + 400 IU of vitamin D3)
445173|NCT00504166|E2|Reported Event|Placebo|placebo to match alendronate sodium
445174|NCT00504166|E1|Reported Event|Alendronate Sodium|alendronate sodium 70 mg tablet once a week for 24 months
445175|NCT00504153|B1|Baseline|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445176|NCT00504153|P1|Participant Flow|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445177|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445178|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445180|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445181|NCT00504153|O1|Outcome|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445182|NCT00504153|E1|Reported Event|Dasatinib (Tyrosine Kinase Inhibitor)|Patients receive oral dasatinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
445183|NCT00504075|B1|Baseline|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445184|NCT00504075|P1|Participant Flow|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445185|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445186|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of Gammaplex was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445187|NCT00504075|O1|Outcome|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445188|NCT00504075|E1|Reported Event|GAMMAPLEX|The first course of GAMMAPLEX was administered as an intravenous infusion of 1g/kg on each of 2 consecutive days. If required, a further 1 or 2 courses on the same dosage regimen was administered in the period Day 32 to Day 90 following the first course of GAMMAPLEX.
445189|NCT00503841|B1|Baseline|Erlotinib Hydrochloride|If participants would have went onto study they would receive erlotinib hydrochloride PO (orally) QD (every day) on days -14-0 immediately prior to scheduled surgery. Treatment continues in the absence of disease progression or unacceptable toxicity.
445190|NCT00503841|P1|Participant Flow|Erlotinib Hydrochloride|"If participants would have went onto study they would receive erlotinib(Tarceva®)hydrochloride 150 mg/day starting dose PO (orally) self-administered, QD (every day) on days -14 until day 0 immediately prior to scheduled surgery, Tissue sent for biomarker modulation analysis~Treatment continues in the absence of disease progression or unacceptable toxicity.~Biomarker analysis performed, toxicity monitored for 7 days following last dose of erlotinib (Tarceva®)"
445191|NCT00503841|O1|Outcome|Erlotinib Hydrochloride|Patients must be willing to consider treatment with erlotinib, in the event they are eligible for the treatment phase of the study. Erlotinib (Tarceva®) will be self-administered in an open-label, unblinded manner to all patients enrolled in the study. During the treatment period, patients will receive single-agent erlotinib (Tarceva®), at a dose of 150 mg/day mg by mouth. Patients will be instructed to take tablets once daily. The day of planned surgical resection of the invasive breast cancer will be considered day 0. Patients will undergo baseline physical examination and performance status evaluation on or before day -14. Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.
445192|NCT00503841|E1|Reported Event|Erlotinib Hydrochloride|Patients will be instructed to take tablets once daily.Patients will begin treatment with erlotinib 150 mg (1 tablet) orally daily on day -14 and it will be continued for a total of 15 days, through day 0.The day of planned surgical resection of the invasive breast cancer will be considered day 0.
445193|NCT00503776|B5|Baseline|Total|Total of all reporting groups
445194|NCT00503776|B4|Baseline|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445195|NCT00503776|B3|Baseline|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445196|NCT00503776|B2|Baseline|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
445197|NCT00503776|B1|Baseline|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445198|NCT00503776|P4|Participant Flow|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445199|NCT00503776|P3|Participant Flow|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445200|NCT00503776|P2|Participant Flow|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
445201|NCT00503776|P1|Participant Flow|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445202|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445203|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445204|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
445205|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445206|NCT00503776|O4|Outcome|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445207|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445208|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
445209|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445211|NCT00503776|O3|Outcome|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445212|NCT00503776|O2|Outcome|Arm IB|Patients undergo SNT and low-weight resistance training (LWRT).
445213|NCT00503776|O1|Outcome|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445214|NCT00503776|E4|Reported Event|Arm IIB|Patients receive amifostine SC 30-60 minutes prior to each dose of IMRT. Patients also undergo SNT and LWRT as in arm IB.
445215|NCT00503776|E3|Reported Event|Arm IIA|Patients receive amifostine subcutaneously (SC) 30-60 minutes prior to each dose of intensity-modulated radiotherapy (IMRT). Patients also undergo SNT as in arm IA.
445216|NCT00503776|E2|Reported Event|Arm IB|Patients undergo SNT and low weight resistance training (LWRT).
445217|NCT00503776|E1|Reported Event|Arm IA|Patients undergo specialized nutrition therapy (SNT) including dietitian counseling and calorie goal instruction.
445218|NCT00503750|B1|Baseline|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
445219|NCT00503750|P1|Participant Flow|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
445220|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
445221|NCT00503750|O1|Outcome|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
445222|NCT00503750|E1|Reported Event|Trastuzumab and Abraxane Followed Trastuzumab and Vinorelbine|Patients will be treated sequentially with preoperative trastuzumab and dose-dense ABI-007 followed by trastuzumab in combination with vinorelbine. Trastuzumab will be administered as a one-time loading dose of 4 mg/kg as a 90 minute infusion, followed by 20 weekly treatments at 2 mg/kg as a 30 minute infusion. ABI-007 will be administered every 2 weeks at a dose of 260mg/m2 as 30 minute infusion on the same days as trastuzumab for a total of 4 cycles (weeks 1 -8). Growth factor support with pegfilgrastim (Neulasta®) is required 24 to 48 hours following completion of each cycle of ABI-007. Beginning week 9, patients will then receive weekly vinorelbine at a dose of 25mg/m2 for 12 weeks on the same day as trastuzumab for a total of 4 cycles (weeks 9-20). As per standard treatment of HER2-positive breast cancers, patients will continue to receive trastuzumab every 3 weeks at 6 mg/kg beginning week 21 through week 52.
445223|NCT00503698|B3|Baseline|Total|Total of all reporting groups
445224|NCT00503698|B2|Baseline|Placebo|Placebo once daily, week 0 to end of trial
445225|NCT00503698|B1|Baseline|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445226|NCT00503698|P2|Participant Flow|Placebo|Placebo once daily, week 0 to end of trial
445227|NCT00503698|P1|Participant Flow|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445228|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
445229|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445230|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
445231|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445232|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
445233|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445234|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
445235|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445236|NCT00503698|O2|Outcome|Placebo|Placebo once daily, week 0 to end of trial
445237|NCT00503698|O1|Outcome|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445238|NCT00503698|E2|Reported Event|Placebo|Placebo once daily, week 0 to end of trial
445239|NCT00503698|E1|Reported Event|Somatropin|Somatropin 20 mcg/kg once daily, week 0 to end of trial
445240|NCT00503425|B1|Baseline|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445241|NCT00503425|P1|Participant Flow|Rituximab|Participants received rituximab (MabThera) 1000 milligrams (mg) intravenous (IV) dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the European League Against Rheumatism (EULAR) response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445242|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445243|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445244|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445245|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445246|NCT00503425|O1|Outcome|Rituximab|Participants received rituximab (MabThera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445247|NCT00503425|E1|Reported Event|Rituximab|Participants received rituximab (Mabthera) 1000 mg IV dose on Days 1 and 15. Participants who completed the Week 36 visit and achieved moderate or good response according to the EULAR response criteria were treated again with rituximab. Rituximab was administered for up to 5 courses.
445248|NCT00503399|B3|Baseline|Total|Total of all reporting groups
445249|NCT00503399|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445250|NCT00503399|B1|Baseline|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445251|NCT00503399|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445252|NCT00503399|P1|Participant Flow|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445253|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445254|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445255|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445256|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445257|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445258|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445259|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445260|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445261|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445262|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445263|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445264|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445265|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445266|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445267|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445268|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445269|NCT00503399|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445270|NCT00503399|O1|Outcome|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445271|NCT00503399|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg) oral (po) tablet once weekly (QW)
445272|NCT00503399|E1|Reported Event|Teriparatide|Teriparatide 20 microgram (µg) subcutaneous (sc) injection once daily (QD)
445273|NCT00503308|B3|Baseline|Total|Total of all reporting groups
445274|NCT00503308|B2|Baseline|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
445275|NCT00503308|B1|Baseline|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
445276|NCT00503308|P2|Participant Flow|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
445277|NCT00503308|P1|Participant Flow|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
445444|NCT00502775|P2|Participant Flow|Fluticasone Furoate 110mcg|
445278|NCT00503308|O2|Outcome|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
445279|NCT00503308|O1|Outcome|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
445280|NCT00503308|E2|Reported Event|Abbreviated Consenting Intervention|The intervention arm used a 2-sentence script which lasted approximately 30 seconds.
445281|NCT00503308|E1|Reported Event|Standard Consenting Intervention|The standardized HIV pre-test counseling and consent process took approximately 2–5 minutes and reviewed the definition of HIV, modes of transmission and prevention, interpretation of test results and the benefits of testing.
445282|NCT00503113|B4|Baseline|Total|Total of all reporting groups
445283|NCT00503113|B3|Baseline|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445284|NCT00503113|B2|Baseline|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445285|NCT00503113|B1|Baseline|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445286|NCT00503113|P3|Participant Flow|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445287|NCT00503113|P2|Participant Flow|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445288|NCT00503113|P1|Participant Flow|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445289|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445290|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445291|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445292|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445293|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445294|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445295|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445296|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445297|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445298|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445299|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445300|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445301|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445302|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445303|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445304|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445305|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445306|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445307|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445308|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445309|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445310|NCT00503113|O3|Outcome|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445311|NCT00503113|O2|Outcome|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445312|NCT00503113|O1|Outcome|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445313|NCT00503113|E3|Reported Event|Alendronate 70 mg Oral|Alendronate was administered as an oral tablet of 70 mg every week (Fosamax 70 mg).
445314|NCT00503113|E2|Reported Event|Ibandronate 3 mg Infusion|Ibandronate was administered as an intravenous (iv) infusion (15 min) of 3 mg every 3 months.
445315|NCT00503113|E1|Reported Event|Ibandronate 3 mg Injection|Ibandronate was administered as an intravenous (iv) injection (15 to 30 seconds) of 3 mg every 3 months.
445316|NCT00503009|B4|Baseline|Total|Total of all reporting groups
445317|NCT00503009|B3|Baseline|Placebo Diskus BID|Placebo twice daily
445318|NCT00503009|B2|Baseline|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445319|NCT00503009|B1|Baseline|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445320|NCT00503009|P3|Participant Flow|Placebo Diskus BID|Placebo twice daily
445321|NCT00503009|P2|Participant Flow|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445322|NCT00503009|P1|Participant Flow|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445323|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
445324|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445325|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445326|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
445327|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445328|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445329|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
445330|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445331|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445332|NCT00503009|O3|Outcome|Placebo Diskus BID|Placebo twice daily
445333|NCT00503009|O2|Outcome|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445334|NCT00503009|O1|Outcome|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445335|NCT00503009|E3|Reported Event|Placebo Diskus BID|Placebo twice daily
445336|NCT00503009|E2|Reported Event|FP 250 mcg BID|Fluticasone Propionate (FP) (250 microgram) twice daily
445337|NCT00503009|E1|Reported Event|FSC 250/50 mcg BID|Fluticasone Propionate/Salmeterol (FSC) (250/50 microgram) twice daily
445338|NCT00502996|B1|Baseline|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445339|NCT00502996|P1|Participant Flow|Rituximab|Eligible participants receiving Rituximab (MabThera/Rituxan) 1 gram/dose (g/dose) intravenously (IV) on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 milligram (mg) IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg per oris (PO) weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445340|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445341|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445342|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445343|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445344|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445345|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445346|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445347|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445348|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445349|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445350|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445351|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445352|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445353|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445354|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445355|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445356|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445357|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445358|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445359|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445360|NCT00502996|O1|Outcome|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445361|NCT00502996|E1|Reported Event|Rituximab|Eligible participants receiving Rituximab 1 g/dose IV on Day 1 and Day 15 followed by previous pre-medication (methylprednisolone 100 mg IV, antihistamine and antipyretic) and concomitant treatment of Methotrexate at least 15 mg PO weekly were observed during the study period of 24 weeks. After treatment completion, participants were followed-up for safety up to 24 weeks.
445362|NCT00502944|B3|Baseline|Total|Total of all reporting groups
445363|NCT00502944|B2|Baseline|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445364|NCT00502944|B1|Baseline|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445365|NCT00502944|P2|Participant Flow|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445366|NCT00502944|P1|Participant Flow|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445367|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445368|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445369|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445370|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445371|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445372|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445373|NCT00502944|O2|Outcome|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445374|NCT00502944|O1|Outcome|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445375|NCT00502944|E2|Reported Event|Provider|Emergency staff member-based HIV screening intervention where an emergency staff member does all the screening.
445376|NCT00502944|E1|Reported Event|Counselor|Counselor-based HIV screening intervention where a dedicated HIV counselor does all the screening.
445377|NCT00502905|B1|Baseline|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
445378|NCT00502905|P1|Participant Flow|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
445379|NCT00502905|O1|Outcome|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
445380|NCT00502905|E1|Reported Event|Busulfan + Fludarabine|Busulfan 130 mg/m^2 + Fludarabine 40 mg/m^2 given daily for four days
445445|NCT00502775|P1|Participant Flow|Placebo|
445446|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445447|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445448|NCT00502775|O1|Outcome|Placebo|
445449|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445450|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445381|NCT00502853|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445382|NCT00502853|P1|Participant Flow|Rituximab Plus (+) Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) intravenously (IV) and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg per week (mg/week) by mouth or parenterally. Nonresponsive participants (defined as Disease Activity Score Based on 28-Joint Count and C-Reactive Protein [DAS28-CRP] score of greater than [>]2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445383|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445384|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445385|NCT00502853|O1|Outcome|Rituximab + MTX|"Participants received 1000 mg of Rituximab by IV infusion on Days 1 and 15 (considered to be one cycle). Participants also received 10-25 mg/week stable concomitant MTX by mouth or parenterally.~Additional cycles of 2 infusions each could be administered provided the following: a minimum of 24 weeks had passed since the first infusion of the last course of study medication; the participant had a DAS28-CRP score of >2.6; the participant had a neutrophil count not below 1.5x10^3/μL; there was an absence of significant cardiac or pulmonary disease, primary or secondary immunodeficiency, and infections."
445386|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445387|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445388|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445389|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445390|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445391|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445392|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445393|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445394|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445395|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445451|NCT00502775|O1|Outcome|Placebo|
445452|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445453|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445454|NCT00502775|O1|Outcome|Placebo|
445396|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445397|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445398|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445399|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445400|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445401|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445402|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445403|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445404|NCT00502853|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445405|NCT00502853|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 1 and 15 and MTX at a stable dose of 10-25 mg/week by mouth or parenterally. Nonresponsive participants (defined as DAS28-CRP score of >2.6) could have received additional infusions of rituximab 1000 mg (2 infusions, 14 days apart) provided a minimum of 24 weeks had passed since the first infusion of the last course of study medication.
445406|NCT00502840|B1|Baseline|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
445407|NCT00502840|P1|Participant Flow|Rituximab Plus Methotrexate (MTX)|Participants received rituximab 1 gram (g), intravenously (IV), and methylprednisolone 100 mg, IV, on Days 1 and 15 (one cycle). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 milligrams (mg) weekly; participants may also have been receiving a stable dose of folic acid. Participants with Disease Activity Score Based on 28 Joint Count (DAS28) greater than or equal to (≥)2.6 and an improvement in DAS28 greater than (>0.6) 16 to 24 weeks following treatment could have received up to two additional cycles of rituximab treatment.
445408|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445409|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445455|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445456|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445457|NCT00502775|O1|Outcome|Placebo|
445458|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445459|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445460|NCT00502775|O1|Outcome|Placebo|
445461|NCT00502775|O3|Outcome|Fexofenadine 180 mg|
445410|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445411|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445412|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445413|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445414|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445415|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445416|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445417|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445418|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445419|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445420|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445421|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445422|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445462|NCT00502775|O2|Outcome|Fluticasone Furoate 110mcg|
445423|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445424|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445425|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445426|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445427|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445428|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445429|NCT00502840|O1|Outcome|Rituximab Pluse MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445430|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445431|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445432|NCT00502840|O1|Outcome|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445433|NCT00502840|E1|Reported Event|Rituximab Plus MTX|Participants received rituximab 1 g, IV, and methylprednisolone 100 mg, IV, on Days 1 and 15 (one course of treatment). Participants should have been receiving mandatory background therapy with MTX (prescribed as necessary by the treating physician) at a stable dose between 7.5 and 25 mg weekly; participants may also have been receiving a stable dose of folic acid. Participants with DAS28 ≥2.6 and an improvement in DAS28 >0.6 16 to 24 weeks following treatment could have received up to two additional courses of rituximab treatment.
445434|NCT00502801|B1|Baseline|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
445435|NCT00502801|P1|Participant Flow|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
445436|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
445437|NCT00502801|O1|Outcome|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
445438|NCT00502801|E1|Reported Event|Doripenem|1g i.v. infused over 4 hours every 8 hours from day 1 to day 8 to 14, depending on length of treatment
445439|NCT00502775|B4|Baseline|Total|Total of all reporting groups
445440|NCT00502775|B3|Baseline|Fexofenadine 180 mg|
445441|NCT00502775|B2|Baseline|Fluticasone Furoate 110mcg|
445442|NCT00502775|B1|Baseline|Placebo|
445443|NCT00502775|P3|Participant Flow|Fexofenadine 180 mg|
445486|NCT00502697|B2|Baseline|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
445487|NCT00502697|B1|Baseline|Treatment Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
445488|NCT00502697|P2|Participant Flow|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care : Women in this group received conventional prenatal care and postpartum clinic care."
445489|NCT00502697|P1|Participant Flow|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
445490|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
445491|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
445492|NCT00502697|O2|Outcome|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
445493|NCT00502697|O1|Outcome|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
445494|NCT00502697|E2|Reported Event|Control Group|"Women assigned to the control arm of the study received conventional prenatal and postpartum clinic care.~Conventional prenatal and postpartum clinic care: Women in this group received conventional prenatal care and postpartum clinic care."
445495|NCT00502697|E1|Reported Event|Intervention Group|Advanced practice nurses provide targeted behavioral interventions during home visits. These visits were in addition to regularly scheduled conventional prenatal and postpartum clinic visits. Specific protocols guided nurse interventions related to tobacco use, substance use and misuse, stress management, dental health, maternal infections, perinatal depressive symptoms, family violence, reproductive life plans and continuity of care. Home visits were continued in the postpartum period (through 18 months post-delivery) with a continued focus on risk factors identified during the prenatal period and internatal health care.
445496|NCT00502671|B1|Baseline|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
445497|NCT00502671|P1|Participant Flow|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine orally (PO) as 1250 milligrams per meter-squared (mg/m^2) twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
445498|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
445499|NCT00502671|O1|Outcome|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
446126|NCT00501293|P1|Participant Flow|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
445500|NCT00502671|E1|Reported Event|Capecitabine|Participants with resected Stage III colon cancer (Dukes C) or high-risk Stage II colon cancer (Dukes B) received capecitabine PO as 1250 mg/m^2 twice daily, once in the morning and once at night, in this non-randomized postmarketing safety study. For those with moderate renal insufficiency at Baseline, the initial dose was reduced to 950 mg/m^2 twice daily. Each 3-week cycle comprised 2 weeks of continuous treatment followed by a 1-week break, and treatment continued for up to 8 cycles (24 weeks) or until relapse, new-onset colon cancer, or unacceptable toxicity.
445501|NCT00502593|B13|Baseline|Total|Total of all reporting groups
445502|NCT00502593|B12|Baseline|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445503|NCT00502593|B11|Baseline|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445504|NCT00502593|B10|Baseline|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445505|NCT00502593|B9|Baseline|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445506|NCT00502593|B8|Baseline|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445507|NCT00502593|B7|Baseline|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445508|NCT00502593|B6|Baseline|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445509|NCT00502593|B5|Baseline|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445510|NCT00502593|B4|Baseline|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445511|NCT00502593|B3|Baseline|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445512|NCT00502593|B2|Baseline|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445513|NCT00502593|B1|Baseline|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445514|NCT00502593|P12|Participant Flow|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445515|NCT00502593|P11|Participant Flow|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445516|NCT00502593|P10|Participant Flow|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445517|NCT00502593|P9|Participant Flow|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445518|NCT00502593|P8|Participant Flow|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445519|NCT00502593|P7|Participant Flow|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445520|NCT00502593|P6|Participant Flow|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446127|NCT00501293|O1|Outcome|Antecedent MTS and Antecedent Placebo|Methylphenidate Transdermal System and Placebo Patch
446174|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
445521|NCT00502593|P5|Participant Flow|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445522|NCT00502593|P4|Participant Flow|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445523|NCT00502593|P3|Participant Flow|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445524|NCT00502593|P2|Participant Flow|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445525|NCT00502593|P1|Participant Flow|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445526|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445527|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group Subjects Aged 6-9 Years Receive|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445528|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445529|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445530|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445531|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445532|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445533|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445534|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445535|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445536|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445537|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445538|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445539|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445540|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445541|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445542|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445543|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445544|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445545|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445546|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445547|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445548|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445549|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445550|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445551|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445552|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445553|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445554|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445555|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445556|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445557|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445558|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445559|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445560|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445561|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445562|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445563|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445564|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445565|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445566|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445567|NCT00502593|O3|Outcome|GSK1562902A–B Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445568|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445569|NCT00502593|O1|Outcome|GSK1562902A –B Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445570|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445571|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445572|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445573|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445574|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445575|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445576|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445577|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445578|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445579|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445580|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Fluarix–A 3-5Y Group
445581|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445582|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445583|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445584|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445585|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445586|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446128|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
445587|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445588|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445589|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445590|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445591|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445592|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445593|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445594|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445595|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445596|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445597|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445598|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445599|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445600|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445601|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445602|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445603|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445604|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445605|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445606|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445607|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445608|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445609|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445610|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445611|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445612|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445613|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445614|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445615|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445616|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445617|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445618|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445619|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445620|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445621|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445622|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445623|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445624|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445625|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445626|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445627|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445628|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445629|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445630|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445631|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445632|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445633|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445634|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445635|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445636|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445637|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445638|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445639|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445640|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445641|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445642|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445643|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445644|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445645|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445646|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445647|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445648|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445649|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445650|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445651|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445652|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445653|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445654|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445655|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445656|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445657|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445658|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445659|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445660|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445661|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445662|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445663|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445664|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445665|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445666|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445667|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445668|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445669|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445670|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445671|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445672|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445673|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445674|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445675|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445676|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445677|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445678|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445679|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445680|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445681|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445682|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445683|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445684|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445685|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445686|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445687|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445688|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445689|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445690|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445691|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445692|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445693|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445694|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445695|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445696|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445697|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445698|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445699|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445700|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445701|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445702|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445703|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445704|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445705|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445706|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445707|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445708|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445709|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445710|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445711|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445712|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445713|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445714|NCT00502593|O6|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445715|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445716|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445717|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445718|NCT00502593|O2|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445719|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445720|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445721|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445722|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445723|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445724|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445725|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445726|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445727|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445728|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445729|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445730|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445731|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445732|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445733|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445734|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445735|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445736|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445737|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445738|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445739|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445740|NCT00502593|O4|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445741|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445742|NCT00502593|O2|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445743|NCT00502593|O1|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445744|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445745|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445746|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445747|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445748|NCT00502593|O6|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445749|NCT00502593|O5|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445750|NCT00502593|O4|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445751|NCT00502593|O3|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445752|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445753|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445754|NCT00502593|O4|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445755|NCT00502593|O3|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445756|NCT00502593|O2|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
445757|NCT00502593|O1|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21
445758|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445759|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445760|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445761|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445762|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445763|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445764|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445765|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445766|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445767|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445768|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445769|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445770|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445771|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445772|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445773|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445774|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445775|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445776|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445777|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445778|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445779|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445780|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445781|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445782|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445783|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445784|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445785|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445786|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445787|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445788|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445789|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445790|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445791|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445792|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445793|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445794|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445795|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445796|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445797|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445798|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445799|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445800|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445801|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445802|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445803|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445804|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445805|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445806|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445807|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445808|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445809|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445810|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445811|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445812|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445813|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445814|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445815|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445816|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445817|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445818|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445819|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445820|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445821|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445822|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445823|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445824|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445825|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445826|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445827|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445828|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445829|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445830|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445831|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445832|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445833|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445834|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445835|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445836|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445837|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445838|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445839|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445840|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445841|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445842|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445843|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445844|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445845|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445846|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445847|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445848|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445849|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445850|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445851|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445852|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445853|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445854|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445855|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445856|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445857|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445858|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445859|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445860|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445861|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445862|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445863|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445864|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445865|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445866|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445867|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445868|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445869|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445870|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445871|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445872|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445873|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445874|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445875|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445876|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445877|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445878|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445879|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445880|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445881|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445882|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445883|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445884|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445885|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445886|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445887|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445888|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445889|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445890|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445891|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445892|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445893|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445894|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445895|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445896|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445897|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445898|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445899|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445900|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445901|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445902|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445903|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445904|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445905|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445906|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445907|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445908|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445909|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445910|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445911|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445912|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445913|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445914|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445915|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445916|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445917|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445918|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445919|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445920|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445921|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445922|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445923|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445924|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445925|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445926|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445927|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445928|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445929|NCT00502593|O1|Outcome|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445930|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445931|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445932|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445933|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445934|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445935|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445936|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445937|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445938|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445939|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445940|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445941|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445942|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445943|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445944|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445945|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445946|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445947|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445948|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445949|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445950|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445951|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445952|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445953|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445954|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445955|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445956|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445957|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445958|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445959|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445960|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445961|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445962|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445963|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445964|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445965|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445966|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445967|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445968|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445969|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445970|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445971|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445972|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445973|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445974|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445975|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445976|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445977|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445978|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445979|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445980|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445981|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445982|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445983|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445984|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445985|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445986|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445987|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445988|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445989|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445990|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445991|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445992|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445993|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445994|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445995|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445996|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445997|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445998|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
445999|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446000|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446001|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446002|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446003|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446004|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446005|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446006|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446007|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446008|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446009|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446010|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446011|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446012|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446013|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446014|NCT00502593|O12|Outcome|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446015|NCT00502593|O11|Outcome|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446016|NCT00502593|O10|Outcome|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446017|NCT00502593|O9|Outcome|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446018|NCT00502593|O8|Outcome|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446019|NCT00502593|O7|Outcome|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446020|NCT00502593|O6|Outcome|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446021|NCT00502593|O5|Outcome|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446022|NCT00502593|O4|Outcome|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446023|NCT00502593|O3|Outcome|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446024|NCT00502593|O2|Outcome|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446025|NCT00502593|O1|Outcome|GSK1562902A–A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446026|NCT00502593|E12|Reported Event|Fluarix–C 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446027|NCT00502593|E11|Reported Event|GSK1562902A–C Lot 3 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446028|NCT00502593|E10|Reported Event|Fluarix–C 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446029|NCT00502593|E9|Reported Event|GSK1562902A–C Lot 3 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 3. These subjects were enrolled in the Phase C of this NCT00502593 study (or study 108500). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446030|NCT00502593|E8|Reported Event|Fluarix–B 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446031|NCT00502593|E7|Reported Event|GSK1562902A–B Lot 2 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446032|NCT00502593|E6|Reported Event|Fluarix–B 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446033|NCT00502593|E5|Reported Event|GSK1562902A–B Lot 2 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 2. These subjects were enrolled in the Phase B of this NCT00502593 study (or study 108498). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446034|NCT00502593|E4|Reported Event|Fluarix–A 6-9Y Group|Subjects aged 6-9 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446035|NCT00502593|E3|Reported Event|GSK1562902A–A Lot 1 6-9Y Group|Subjects aged 6-9 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446036|NCT00502593|E2|Reported Event|Fluarix–A 3-5Y Group|Subjects aged 3-5 years received 2 doses of Fluarix™ vaccine. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446037|NCT00502593|E1|Reported Event|GSK1562902A –A Lot 1 3-5Y Group|Subjects aged 3-5 years received 2 doses of GSK1562902A vaccine, lot 1. These subjects were enrolled in the Phase A of this NCT00502593 study (or study 107066). The GSK1562902A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm on Days 0 and 21.
446038|NCT00502320|B3|Baseline|Total|Total of all reporting groups
446039|NCT00502320|B2|Baseline|Placebo|inactive sugar pill taken by mouth nightly
446040|NCT00502320|B1|Baseline|Ramelteon|8 mg pill taken by mouth nightly
446041|NCT00502320|P2|Participant Flow|Placebo|inactive sugar pill taken by mouth nightly
446042|NCT00502320|P1|Participant Flow|Ramelteon|8 mg pill taken by mouth nightly
446043|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
446044|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
446045|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
446046|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
446047|NCT00502320|O2|Outcome|Placebo|inactive sugar pill taken by mouth nightly
446048|NCT00502320|O1|Outcome|Ramelteon|8 mg pill taken by mouth nightly
446049|NCT00502320|E2|Reported Event|Placebo|inactive sugar pill taken by mouth nightly
446050|NCT00502320|E1|Reported Event|Ramelteon|8 mg pill taken by mouth nightly
446051|NCT00502242|B3|Baseline|Total|Total of all reporting groups
446052|NCT00502242|B2|Baseline|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446053|NCT00502242|B1|Baseline|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446054|NCT00502242|P2|Participant Flow|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446055|NCT00502242|P1|Participant Flow|Ramipril|Participants were receiving cyclosporine (CsA) or tacrolimus (TAC) and either mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) or steroids dosed per center’s standard of care. Participants received ramipril, 5 or 10 milligrams per day (mg/d) orally (PO). 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of sirolimus [SRL] initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 nanograms per milliliter [ng/mL] less than [<]1 year post-transplant [PT], 5-15 ng/mL greater than or equal to [≥]1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if urinary protein to creatinine ratio (U p/c) was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446056|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446057|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446058|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446059|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446060|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446061|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446062|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446063|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446129|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446288|NCT00500682|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
446064|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446065|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446066|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446067|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446068|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446069|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446070|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446071|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446072|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446130|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446131|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446289|NCT00500682|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
446073|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446074|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446075|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446076|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446077|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446078|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446079|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446080|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446081|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446132|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446133|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446290|NCT00500682|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
446082|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446083|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446084|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446085|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446086|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446087|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446088|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446089|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446090|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446134|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446135|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446291|NCT00500682|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
446091|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446092|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446093|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446094|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446095|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446096|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446097|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446098|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446099|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446136|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446137|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446292|NCT00500682|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
446100|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446101|NCT00502242|O2|Outcome|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446102|NCT00502242|O1|Outcome|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446103|NCT00502242|E2|Reported Event|Placebo|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received double-blinded placebo, 1 capsule (5 or 10 mg/day), PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Placebo dose was doubled if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446104|NCT00502242|E1|Reported Event|Ramipril|Participants were receiving CsA or TAC and either MMF, MPS, or AZA or steroids dosed per center’s standard of care. Participants received ramipril 5 or 10 mg/d PO. 2-6 weeks after randomization, participants stopped TAC or CsA (within 21 days of SRL initiation) and received SRL, PO, 2-4 mg/d (6-12 mg on Day 1 if TAC or CsA withdrawn abruptly) to achieve target trough levels (7-15 ng/mL <1 year PT, 5-15 ng/mL ≥1 year PT) for up to 52 weeks. Ramipril was increased to 10-20 mg if U p/c was ≥0.5. If U p/c ≥0.5 persisted, losartan 50 mg/d was added; if U p/c ≥0.5 still persisted, losartan was increased to 100 mg/d. If then U p/c <0.5 was not maintained, study medication was discontinued and participant entered off-therapy phase of study.
446105|NCT00502216|B3|Baseline|Total|Total of all reporting groups
446106|NCT00502216|B2|Baseline|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
446107|NCT00502216|B1|Baseline|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
446108|NCT00502216|P2|Participant Flow|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
446109|NCT00502216|P1|Participant Flow|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
446110|NCT00502216|O2|Outcome|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
446111|NCT00502216|O1|Outcome|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
446112|NCT00502216|E2|Reported Event|Varenicline + Placebo|Arm 2 (Placebo Comparator) = Varenicline (Chantix) 1 mg oral tablet twice per day + placebo naltrexone 25 mg oral capsule once per day
446113|NCT00502216|E1|Reported Event|Varenicline + Naltrexone|Arm 1 (Experimental) = Varenicline (Chantix) 1 mg oral tablet twice per day + naltrexone 25 mg oral capsule once per day
446114|NCT00502203|B1|Baseline|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
446115|NCT00502203|P1|Participant Flow|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
446116|NCT00502203|O1|Outcome|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
446117|NCT00502203|E1|Reported Event|Paclitaxel + Carboplatin|Paclitaxel 175 mg/m^2 intravenously (IV) over 3 hours and Carboplatin AUC 5 IV over 1 hour every 21 Days for 6 courses.
446118|NCT00501345|B1|Baseline|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
446119|NCT00501345|P1|Participant Flow|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
446120|NCT00501345|O1|Outcome|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
446121|NCT00501345|E1|Reported Event|Aspirin|325 mg by mouth Day 1, 160 mg daily thereafter
446122|NCT00501293|B3|Baseline|Total|Total of all reporting groups
446123|NCT00501293|B2|Baseline|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446124|NCT00501293|B1|Baseline|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446125|NCT00501293|P2|Participant Flow|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446138|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446139|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446140|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446141|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446142|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446143|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446144|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446145|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446146|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446147|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446148|NCT00501293|O2|Outcome|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446149|NCT00501293|O1|Outcome|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446150|NCT00501293|E2|Reported Event|Antecedent Placebo|Subjects who had previously received placebo in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446151|NCT00501293|E1|Reported Event|Antecedent Methylphenidate Transdermal System (MTS)|Subjects who had previously received MTS in the antecedent study, SPD485-409. Upon entry into this study (SPD485-410), all subjects received MTS treatment.
446152|NCT00501228|B1|Baseline|Filgrastim Injections|
446153|NCT00501228|P1|Participant Flow|Filgrastim Injections|
446154|NCT00501228|O1|Outcome|Filgrastim Injections|
446155|NCT00501228|E1|Reported Event|Filgrastim Injections|
446156|NCT00501995|B1|Baseline|IV Cyclophosphamide (50 mg/kg)|This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)
446157|NCT00501995|P1|Participant Flow|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
446158|NCT00501995|O1|Outcome|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
446159|NCT00501995|E1|Reported Event|IV Cyclophosphamide (50 mg/kg)|"This is an open-labeled single arm study of Cyclophosphamide (50 mg/kg) administered intravenously over 1 hour daily for four consecutive days (200 mg/kg total) through a Hickman catheter .~IV Cyclophosphamide: Cyclophosphamide (50 mg/kg) intravenously daily for 4 consecutive days (total 200 mg/kg) followed by granulocyte colony-stimulating factor (5 µg/kg/day)"
446160|NCT00501969|B1|Baseline|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446161|NCT00501969|P1|Participant Flow|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446162|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446163|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446164|NCT00501969|O1|Outcome|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446165|NCT00501969|E1|Reported Event|Rotigotine|Optimal dosing for Rotigotine transdermal patches, once daily: Subjects can receive a dose up to 16 mg/24 hours.
446166|NCT00501943|B3|Baseline|Total|Total of all reporting groups
446167|NCT00501943|B2|Baseline|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
446168|NCT00501943|B1|Baseline|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
446169|NCT00501943|P2|Participant Flow|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
446170|NCT00501943|P1|Participant Flow|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
446171|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446172|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446173|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
453505|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
446175|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446176|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446177|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446178|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446179|NCT00501943|O2|Outcome|Placebo|"placebo~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446180|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole or Placebo, and Avonex(Interferon beta 1a): Riluzole, Placebo and Avonex(Interferon beta 1a)"
446181|NCT00501943|O2|Outcome|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
446182|NCT00501943|O1|Outcome|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
446183|NCT00501943|E2|Reported Event|Placebo|"placebo~1 tab of Placebo BID added to weekly injection of Interferon beta 1a"
446184|NCT00501943|E1|Reported Event|Riluzole|"Riluzole~Riluzole 50 mg BID added to weekly injection of Interferon beta 1a"
446185|NCT00501891|B1|Baseline|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446186|NCT00501891|P1|Participant Flow|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446187|NCT00501891|O1|Outcome|Bevacizumab and Metromonic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446188|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446189|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446190|NCT00501891|O1|Outcome|Bevacizumab and Metronomic Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446191|NCT00501891|E1|Reported Event|Bevacizumab and Temozolomide|Patients will receive up to 12 cycles of Avastin and temozolomide, and each cycle is 28 days. Avastin will be administered at 10 mg/kg every other week beginning a minimum of 7 days after a biopsy or 28 days after a craniotomy. Temozolomide will be dosed at 50 mg/m2 daily in a 28-day cycle.
446192|NCT00501852|B1|Baseline|Overall Study|
446193|NCT00501852|P1|Participant Flow|Overall Study|
446194|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446195|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446196|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446197|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446198|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446199|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446200|NCT00501852|O6|Outcome|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446201|NCT00501852|O5|Outcome|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446202|NCT00501852|O4|Outcome|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446203|NCT00501852|O3|Outcome|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446204|NCT00501852|O2|Outcome|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446205|NCT00501852|O1|Outcome|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446206|NCT00501852|E6|Reported Event|Tiotropium Bromide|18 µg od via Handihaler inhaler. Tiotropium was given open-label. At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446207|NCT00501852|E5|Reported Event|Placebo|Placebo via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446208|NCT00501852|E4|Reported Event|NVA237 100 ug|100 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446209|NCT00501852|E3|Reported Event|NVA237 50 ug|50 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446210|NCT00501852|E2|Reported Event|NVA237 25 ug|25 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446211|NCT00501852|E1|Reported Event|NVA237 12.5 ug|12.5 µg daily via single-dose dry-powder inhaler (SDDPI). At baseline visits for each of the 4 double-blind treatment periods, patients were randomized to one of 30 treatment sequences. There was a 7 day washout period between each sequence.
446212|NCT00501644|B1|Baseline|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
446213|NCT00501644|P1|Participant Flow|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
446214|NCT00501644|O1|Outcome|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
446215|NCT00501644|E1|Reported Event|Chemoimmunotherapy|GM-CSF Starting dose of 400 mg injected under the skin once a day for 7 days prior to and following each course of chemotherapy + rIFN-g (Interferon Gamma) 0.1 mg injected under the skin for 2 days before and after chemotherapy (Day 5 and Day 7 of each 7-day GM-CSF cycle) + Paraplatin (Carboplatin) AUC of 5 by 1 hour IV infusion every 28 days
446216|NCT00501631|B3|Baseline|Total|Total of all reporting groups
446217|NCT00501631|B2|Baseline|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
446218|NCT00501631|B1|Baseline|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
446219|NCT00501631|P2|Participant Flow|Placebo for VIVITROL 380 mg|All subjects who received at least 1 injection of Placebo for VIVITROL. Arm includes all subjects who received at least 1 injection of placebo. After successfully completing screening subjects were administered placebo by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
446220|NCT00501631|P1|Participant Flow|VIVITROL 380 mg|Arm includes all subjects who received at least 1 injection of VIVITROL. After successfully completing screening subjects were administered VIVITROL 380 mg by intramuscular (IM) injection every 4 weeks for a total of 3 injections. Randomization was 1:1 (VIVITROL:placebo) and stratified by site.
446221|NCT00501631|O2|Outcome|Placebo|
446222|NCT00501631|O1|Outcome|Vivitrol|
446223|NCT00501631|E2|Reported Event|Placebo for VIVITROL 380 mg (Double-blind Period)|
446224|NCT00501631|E1|Reported Event|VIVITROL 380 mg (Double-blind Period)|
446225|NCT00501592|B4|Baseline|Total|Total of all reporting groups
446226|NCT00501592|B3|Baseline|Placebo|Once daily by mouth
446227|NCT00501592|B2|Baseline|50 mg INT-747|Once daily by mouth
446228|NCT00501592|B1|Baseline|25 mg INT-747|Once daily by mouth
446229|NCT00501592|P3|Participant Flow|Placebo|Once daily by mouth
446230|NCT00501592|P2|Participant Flow|50 mg INT-747|Once daily by mouth
446231|NCT00501592|P1|Participant Flow|25 mg INT-747|Once daily by mouth
446232|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
446233|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
446234|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
446235|NCT00501592|O3|Outcome|Placebo|Once daily by mouth
446236|NCT00501592|O2|Outcome|50 mg INT-747|Once daily by mouth
446237|NCT00501592|O1|Outcome|25 mg INT-747|Once daily by mouth
446238|NCT00501592|E3|Reported Event|Placebo|Once daily by mouth
446239|NCT00501592|E2|Reported Event|50 mg INT-747|Once daily by mouth
446240|NCT00501592|E1|Reported Event|25 mg INT-747|Once daily by mouth
446241|NCT00501085|B1|Baseline|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446242|NCT00501085|P1|Participant Flow|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446243|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446244|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446245|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446246|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446247|NCT00501085|O1|Outcome|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446248|NCT00501085|E1|Reported Event|LAP-BAND|"Patients who receive the LAP-BAND AP Adjustable Gastric Banding System.~LAP-BAND AP Adjustable Gastric Banding System: Reduction of food intake due to creation of smaller stomach pouch."
446249|NCT00501046|B3|Baseline|Total|Total of all reporting groups
446250|NCT00501046|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
446251|NCT00501046|B1|Baseline|AST-120|AST-120: 9g /day (3 times a day)
446252|NCT00501046|P2|Participant Flow|Placebo|Placebo: 9g /day (3 times a day)
446253|NCT00501046|P1|Participant Flow|AST-120|AST-120: 9g /day (3 times a day)
446254|NCT00501046|O2|Outcome|Placebo|Placebo: 9g /day (3 times a day)
446255|NCT00501046|O1|Outcome|AST-120|AST-120: 9g /day (3 times a day)
446256|NCT00501046|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
446257|NCT00501046|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
446258|NCT00501007|B1|Baseline|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
446259|NCT00501007|P2|Participant Flow|Smokers With Schizophrenia / Schizoaffective Disorder|Smokers meeting criteria for schizophrenia or schizoaffective disorder
446260|NCT00501007|P1|Participant Flow|Non-psychiatric Smokers|Smokers without a diagnosis of schizophrenia or schizoaffective disorder
446261|NCT00501007|O1|Outcome|Smoking Cessation|Participants received tobacco dependence treatment
446262|NCT00501007|O2|Outcome|Non-psychiatric Group|Smokers NOT meeting criteria for schizophrenia, schizophrenia, bipolar disorder.
446263|NCT00501007|O1|Outcome|Schizophrenia or Schizoaffective Disorder|Smokers meeting Diagnostic and Statistical Manual criteria for Schizophrenia or Schizoaffective Disorder
446264|NCT00501007|E1|Reported Event|Diagnosis|Non-psychiatric group vs. Schizophrenia / Schizoaffective disorder
446265|NCT00500760|B3|Baseline|Total|Total of all reporting groups
446266|NCT00500760|B2|Baseline|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446267|NCT00500760|B1|Baseline|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446268|NCT00500760|P2|Participant Flow|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446269|NCT00500760|P1|Participant Flow|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446270|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446271|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446272|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446273|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446274|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446275|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446276|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446277|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446278|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446279|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446280|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446281|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446282|NCT00500760|O2|Outcome|Chemoradiotherapy Alone|Participants received standard radiation therapy for 7 weeks and cisplatin 100 mg/m^2 on Days 1, 22, and 43.
446283|NCT00500760|O1|Outcome|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446284|NCT00500760|E2|Reported Event|Chemotherapy Plus Radiotherapy|
446285|NCT00500760|E1|Reported Event|Panitumumab Plus Chemoradiation|Participants received standard radiation therapy for 7 weeks, cisplatin 75 mg/m^2 and panitumumab 9 mg/kg intravenously on Days 1, 22 and 43.
446286|NCT00500682|B3|Baseline|Total|Total of all reporting groups
446287|NCT00500682|B2|Baseline|Placebo|Placebo: 9g /day (3 times a day)
446293|NCT00500682|E2|Reported Event|Placebo|Placebo: 9g /day (3 times a day)
446294|NCT00500682|E1|Reported Event|AST-120|AST-120: 9g /day (3 times a day)
446295|NCT00500656|B5|Baseline|Total|Total of all reporting groups
446296|NCT00500656|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
446297|NCT00500656|B3|Baseline|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
446298|NCT00500656|B2|Baseline|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
446299|NCT00500656|B1|Baseline|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
446300|NCT00500656|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing were treated in the open label phase with icatibant
446301|NCT00500656|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
446302|NCT00500656|P2|Participant Flow|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
446303|NCT00500656|P1|Participant Flow|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
446304|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
446305|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
446306|NCT00500656|O2|Outcome|Randomized Controlled-Tranexamic Acid|Patients who were randomized to received oral Tranexamic acid + S.C. placebo(solution for injection, matched to icatibant for injection) in the controlled phase after they had an eligible first in-study attack.
446307|NCT00500656|O1|Outcome|Randomized Controlled -Icatibant|Patients who were randomized to icatibant + Oral placebo (hard capsule matched to tranexamic acid) in the controlled phase after they had an eligible first in-study attack.
446308|NCT00500656|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
446309|NCT00500656|E5|Reported Event|Open Label Extension Phase (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase and Open label extension phase.
446310|NCT00500656|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant+ oral placebo or Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
446311|NCT00500656|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
446312|NCT00500656|E2|Reported Event|Controlled Phase- Tranexamic Acid (Randomized Subjects)|Patients who were randomized to Tranexamic acid+ S.C. placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
446313|NCT00500656|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant+ oral placebo in the controlled phase and experienced adverse events while participating in the controlled phase
446314|NCT00500578|B3|Baseline|Total|Total of all reporting groups
446315|NCT00500578|B2|Baseline|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
446316|NCT00500578|B1|Baseline|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
446317|NCT00500578|P2|Participant Flow|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
446318|NCT00500578|P1|Participant Flow|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
446319|NCT00500578|O2|Outcome|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
446320|NCT00500578|O1|Outcome|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
446321|NCT00500578|E2|Reported Event|Modified Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 3 hours every 8 hours
446322|NCT00500578|E1|Reported Event|Standard Schedule - Ribavarin|Aerosolized Ribavirin 6 gm over 18 hours every 24 hours
446323|NCT00500539|B1|Baseline|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
446324|NCT00500539|P1|Participant Flow|Omalizumab|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
446325|NCT00500539|O1|Outcome|Follow-up Period|Participants were assessed at 16 weeks after the last dose of study drug
446326|NCT00500539|O1|Outcome|Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
446327|NCT00500539|O1|Outcome|Follow-up Period|Participants were evaluated at 16 weeks after the last dose of study drug.
446328|NCT00500539|E2|Reported Event|Omalizumab Follow up Period|Participants were assessed at 16 weeks after the last dose of study drug
446329|NCT00500539|E1|Reported Event|Omalizumab Treatment Period|The determined dose was injected subcutaneously every 2 weeks or every 4 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level; a dosing table was used.
446330|NCT00500448|B3|Baseline|Total|Total of all reporting groups
446331|NCT00500448|B2|Baseline|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446332|NCT00500448|B1|Baseline|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446333|NCT00500448|P2|Participant Flow|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446334|NCT00500448|P1|Participant Flow|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446335|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446336|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446337|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446338|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446339|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446340|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446341|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446342|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446343|NCT00500448|O2|Outcome|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446344|NCT00500448|O1|Outcome|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446345|NCT00500448|E2|Reported Event|Neuromuscular Electrical Stimulation|"Neuromuscular electrical stimulation treatments 3 times per week for 4 weeks~Neuromuscular Electrical Stimulation (Vectra Genisys 4 Channel Electrotherapy System): Estim will be delivered 3 times per week for 4 weeks"
446346|NCT00500448|E1|Reported Event|No Treatment|No treatment was delivered to this arm. Participants went about activities of daily living
446347|NCT00500370|B3|Baseline|Total|Total of all reporting groups
446348|NCT00500370|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446349|NCT00500370|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446350|NCT00500370|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446351|NCT00500370|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446352|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446353|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446354|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446355|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446356|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446357|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446358|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446359|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446360|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446361|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446362|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446363|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446364|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446365|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446366|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446367|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446368|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446369|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446370|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446371|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446372|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446373|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446374|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446375|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446376|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446377|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446378|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446379|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446380|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446381|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446382|NCT00500370|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446383|NCT00500370|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446384|NCT00500370|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks plus LMP
446385|NCT00500370|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks plus lifestyle modification plan (LMP), followed by exenatide 10mcg twice daily for 20 weeks plus LMP
446386|NCT00500357|B1|Baseline|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446387|NCT00500357|P1|Participant Flow|13vPnC (Vax 3 Follow-up / NCT00500357)|Administered 13vPnC 0.5 milliliters (mL) intramuscularly (IM) at Year 0 (Vaccination 1 [Vax 1]) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446388|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446389|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
446390|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446391|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
446392|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) core study/NCT00269672. Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446393|NCT00500357|O1|Outcome|13vPnC / 23vPS (Vax 2 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500).
446394|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446395|NCT00500357|O1|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up/NCT00500357)|Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446396|NCT00500357|O2|Outcome|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study/NCT00500357)|13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).
446397|NCT00500357|O1|Outcome|13vPnC (Vax 1 Core Study/NCT00269672)|13vPnC 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500).
446398|NCT00500357|E7|Reported Event|13vPnC-AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446399|NCT00500357|E6|Reported Event|13vPnC+AlPO4/23vPS (After Vax 2 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446448|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
446400|NCT00500357|E5|Reported Event|13vPnC+AlPO4/13vPnC+AlPO4 (After Vax 2 Core Study)|Administered 13vPnC + AlPO4 0.5 mL IM at Year 0 (Vax 1) followed by 13vPnC+AlPO4 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446401|NCT00500357|E4|Reported Event|23vPS (After Vax 1 Core Study)|Administered 23vPS 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446402|NCT00500357|E3|Reported Event|13vPnC-AlPO4 (After Vax 1 Core Study)|Administered 13vPnC-AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446403|NCT00500357|E2|Reported Event|13vPnC+AlPO4 (After Vax 1 Core Study)|Administered 13vPnC+AlPO4 0.5 mL IM at Year 0 (Vax 1) in core study/NCT00269672 (6115A1-500). Events reported Day 1 up to Day 29 postvaccination.
446404|NCT00500357|E1|Reported Event|13vPnC / 23vPS / 13vPnC (Vax 3 Follow-up Study)|"Administered 13vPnC 0.5 mL IM at Year 0 (Vax 1) followed by 23vPS 0.5 mL IM at Year 1 (Vax 2) in core study/NCT00269672 (6115A1-500). Administered 13vPnC 0.5 mL IM at Year 2 (Vax 3) in follow-up study/NCT00500357 (6115A1-3009).~For 13vPnC / 23vPS / 13vPnC (Vax 3 follow-up study) Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=7; systematic (solicited) Any Local Reactions N=41; systematic (solicited) Any Systemic Events N=46."
446405|NCT00500318|B3|Baseline|Total|Total of all reporting groups
446406|NCT00500318|B2|Baseline|Placebo|Dose-matched placebo, oral inhalation, once per day.
446407|NCT00500318|B1|Baseline|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446408|NCT00500318|P2|Participant Flow|Placebo|Dose-matched placebo, oral inhalation, once per day.
446409|NCT00500318|P1|Participant Flow|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446410|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
446411|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446412|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
446413|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446414|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
446415|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446416|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
446417|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446418|NCT00500318|O2|Outcome|Placebo|Dose-matched placebo, oral inhalation, once per day.
446419|NCT00500318|O1|Outcome|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446420|NCT00500318|E2|Reported Event|Placebo|Dose-matched placebo, oral inhalation, once per day.
446421|NCT00500318|E1|Reported Event|Aclidinium|Aclidinium bromide, 200 micrograms, oral inhalation once per day.
446422|NCT00500292|B4|Baseline|Total|Total of all reporting groups
446423|NCT00500292|B3|Baseline|Placebo Plus FOLFOX|placebo plus FOLFOX
446424|NCT00500292|B2|Baseline|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
446425|NCT00500292|B1|Baseline|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
446426|NCT00500292|P3|Participant Flow|Placebo Plus FOLFOX|placebo plus FOLFOX
446427|NCT00500292|P2|Participant Flow|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
446428|NCT00500292|P1|Participant Flow|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
446429|NCT00500292|O3|Outcome|Placebo Plus FOLFOX|placebo plus FOLFOX
446430|NCT00500292|O2|Outcome|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
446431|NCT00500292|O1|Outcome|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
446432|NCT00500292|E3|Reported Event|Placebo Plus FOLFOX|placebo plus FOLFOX
446433|NCT00500292|E2|Reported Event|Vandetanib 300 mg Plus FOLFOX|vandetanib 300 mg plus FOLFOX
446434|NCT00500292|E1|Reported Event|Vandetanib 100 mg Plus FOLFOX|vandetanib 100 mg plus FOLFOX
446435|NCT00500266|B1|Baseline|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
446436|NCT00500266|P1|Participant Flow|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
446437|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
446438|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
446439|NCT00500266|O1|Outcome|13vPnC|Participants received single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) into the deltoid muscle of the arm.
446440|NCT00500266|E2|Reported Event|13vPnC: 6-month Follow-up|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. At visit 3, the 6-month follow-up (166-194 days after Visit 1) only newly diagnosed chronic medical conditions were collected as AEs. SAEs were collected throughout the study.
446441|NCT00500266|E1|Reported Event|13vPnC: Visit 1 to Visit 2|Participants received a single 0.5 mL dose of 13vPnC into the deltoid muscle of the arm once during the study. Local reactions and systemic events were collected from Day 1 through Day 14. AEs were recorded from Visit 1 to Visit 2 (29-43 days after Visit 1). SAEs were collected throughout the study.
446442|NCT00500240|B3|Baseline|Total|Total of all reporting groups
446443|NCT00500240|B2|Baseline|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
446444|NCT00500240|B1|Baseline|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
446445|NCT00500240|P2|Participant Flow|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
446446|NCT00500240|P1|Participant Flow|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
446447|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
446449|NCT00500240|O2|Outcome|Intervention Group|Intense blood sugar management with Insulin Aspart + Insulin Glargine
446450|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin
446451|NCT00500240|O2|Outcome|Intensive Insulin|Intervention Group - Intense blood sugar management with Insulin Aspart + Insulin Glargine
446452|NCT00500240|O1|Outcome|Conventional Care|Control Group - Conventional care using blood sugar management with regular human insulin.
446453|NCT00500240|E2|Reported Event|Intensive Insulin|Intervention Group: Intense blood sugar management with Insulin Aspart + Insulin Glargine
446454|NCT00500240|E1|Reported Event|Conventional Care|Control Group: Conventional care using blood sugar management with regular human insulin.
446455|NCT00500149|B1|Baseline|Entire Study Population|
446456|NCT00500149|P2|Participant Flow|Placebo First|Matching placebo was given orally once daily for 1 week in the first intervention and Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the second intervention
446457|NCT00500149|P1|Participant Flow|Vyvanse First|Vyvanse was dosed orally once daily at either 30, 50 or 70 mg (depending on the outcome of the dose optimization phase)for 1 week in the first intervention and matching placebo was given orally once daily for 1 week in the second intervention
446458|NCT00500149|O2|Outcome|Placebo|Matching placebo
446459|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446460|NCT00500149|O2|Outcome|Placebo|Matching placebo
446461|NCT00500149|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446462|NCT00500149|E2|Reported Event|Placebo|
446463|NCT00500149|E1|Reported Event|Vyvanse|
446464|NCT00500110|B1|Baseline|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
446465|NCT00500110|P1|Participant Flow|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
446466|NCT00500110|O1|Outcome|Treatment|
446467|NCT00500110|E1|Reported Event|Hormonal Ablation, Imatinib + Docetaxel|Imatinib Mesylate 600 mg by mouth (PO) daily + Docetaxel 30 mg/m^2 by vein (IV) weekly + Hormonal Ablation (Goserelin Acetate or Leuprolide) injections every other month or every 3 months
446468|NCT00500071|B1|Baseline|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446469|NCT00500071|P1|Participant Flow|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446470|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446471|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446472|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446473|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446474|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446475|NCT00500071|O1|Outcome|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446476|NCT00500071|E1|Reported Event|Vyvanse|Lisdexamfetamine dimesylate (LDX)
446477|NCT00499915|B3|Baseline|Total|Total of all reporting groups
446478|NCT00499915|B2|Baseline|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
446479|NCT00499915|B1|Baseline|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
446480|NCT00499915|P2|Participant Flow|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
446481|NCT00499915|P1|Participant Flow|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
446482|NCT00499915|O2|Outcome|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
446483|NCT00499915|O1|Outcome|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
446484|NCT00499915|E2|Reported Event|Comparison|"Parents of children in the active comparator group will receive asthma education at NICU discharge.~Asthma Education with Secondhand Smoke Reduction: Parents of children in the active comparator group will receive asthma education at NICU discharge but no secondhand smoke reduction program will be implemented."
446485|NCT00499915|E1|Reported Event|Treatment|"Parents of children in the experimental group will receive asthma education at NICU discharge as well as secondhand smoke reduction program.~Secondhand Smoke Reduction, Smoking Cessation: Parents of children in the experimental group will receive asthma education at NICU discharge as well as a secondhand smoke reduction program including feedback about the children's cotinine levels."
446525|NCT00499694|O1|Outcome|Bevacizumab and Satraplatin|"Bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) Bevacizumab: 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
446568|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
446486|NCT00499889|B1|Baseline|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446487|NCT00499889|P1|Participant Flow|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446488|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446489|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446490|NCT00499889|O1|Outcome|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446491|NCT00499889|E1|Reported Event|Mesylate, Busulfan, Fludarabine + Antithymocyte Globulin|Oral Imatinib Mesylate 400 mg twice a day for 9 Days; Busulfan 130 mg/m^2 by vein (IV) daily for 2 Days; Fludara 40 mg/m^2 IV daily for 4 Days; Antithymocyte Globulin (ATG) 2.5 mg/kg IV daily for 3 Days; Tacrolimus levels maintained between 5-15 ng/dl, Day -2 to Day 180; Methotrexate 5 mg/m2 on days 1, 3, 6 and 11; and Donor bone marrow or blood stem cells infused on day 0 with possible donor lymphocyte infusion (DLI) for progressive disease.
446492|NCT00499863|B3|Baseline|Total|Total of all reporting groups
446493|NCT00499863|B2|Baseline|Placebo (PTS)|Placebo Transdermal System
446494|NCT00499863|B1|Baseline|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446495|NCT00499863|P2|Participant Flow|Placebo (PTS)|Placebo Transdermal System
446496|NCT00499863|P1|Participant Flow|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446497|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446498|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446499|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446500|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446501|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446502|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446503|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446504|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446505|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446506|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446507|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446508|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446509|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446510|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446511|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446512|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446513|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446514|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446515|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446516|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446517|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446518|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446519|NCT00499863|O2|Outcome|Placebo (PTS)|Placebo Transdermal System
446520|NCT00499863|O1|Outcome|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446521|NCT00499863|E2|Reported Event|Placebo (PTS)|Placebo Transdermal System
446522|NCT00499863|E1|Reported Event|Methylphenidate Transdermal System|Methylphenidate Transdermal System Patch
446523|NCT00499694|B1|Baseline|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
446524|NCT00499694|P1|Participant Flow|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
446564|NCT00499590|E1|Reported Event|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
446526|NCT00499694|E1|Reported Event|Bevacizumab and Satraplatin|"Bevacizumab 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~Satraplatin 80 mg/m(2), Orally, Days 1-5, every 35 days~bevacizumab: 10mg/kg,Intravenous, Day 1 of each Cycle (every 35 days) 15mg/kg,Intravenous, Day 15 of each Cycle (every 35 days)~satraplatin: 80 mg/m(2), Orally, Days 1-5, every 35 days"
446527|NCT00499681|B3|Baseline|Total|Total of all reporting groups
446528|NCT00499681|B2|Baseline|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
446529|NCT00499681|B1|Baseline|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
446530|NCT00499681|P2|Participant Flow|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
446531|NCT00499681|P1|Participant Flow|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
446532|NCT00499681|O2|Outcome|Part 1: Letrozole Plus Placebo Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with a placebo and 14 weeks treatment with letrozole and lapatinib
446533|NCT00499681|O1|Outcome|Part I and Part II Letrozole Plus Laptinab|Participants received 2 weeks treatment with letrozole with lapatinib and 14 weeks treatment with letrozole and lapatinib
446534|NCT00499681|E2|Reported Event|Placebo + Letrozole, Then Lapatinib + Letrozole|Part I: some participants received Placebo + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional. FDG-PET/CT scan. Part II: participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks
446535|NCT00499681|E1|Reported Event|Lapatinib + Letrozole, Then Lapatinib + Letrozole|Part I: Some participants received Lapatinib 1500mg + Letrozole 2.5mg once daily (QD) for 2 weeks. Participants then underwent ultrasound imaging for tumor measurement, a core biopsy for molecular markers, and an optional FDG-PET/CT scan. Part II, participants received Lapatinib 1500mg + Letrozole 2.5mg QD for 14 weeks.
446536|NCT00499603|B3|Baseline|Total|Total of all reporting groups
446537|NCT00499603|B2|Baseline|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446538|NCT00499603|B1|Baseline|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446539|NCT00499603|P2|Participant Flow|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446540|NCT00499603|P1|Participant Flow|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446541|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446542|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446565|NCT00499486|B1|Baseline|Sirolimus|adencarcinoma refractory to gemcitibine
446566|NCT00499486|P1|Participant Flow|Sirolimus|Patients with advanced pancreatic adenocarcinoma refractory to gemcitibine received Sirolimus at a single oral flat dose of 5 mg. per day. A treatment cycle was 28 days.
446567|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
446543|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446544|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide: 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446545|NCT00499603|O2|Outcome|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446546|NCT00499603|O1|Outcome|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446547|NCT00499603|E2|Reported Event|Paclitaxel + RAD001 + FEC|"Paclitaxel + RAD001 Followed by FEC (5-Fluorouracil + Epirubicin + Cyclophosphamide)~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~RAD001 : 30 mg by mouth weekly on Days 1, 8, & 15 for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446548|NCT00499603|E1|Reported Event|Paclitaxel + FEC|"Paclitaxel 80 mg/m^2 intravenously (IV) on day 1(+/- 2 days) of each week, followed by four cycles of combination 5-Fluorouracil at 500 mg/m^2, Epirubicin at 100 mg/m^2 and Cyclophosphamide at 500 mg/m^2 (FEC) on day 1 every 3 weeks (+/- 7 days).~5-Fluorouracil : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Paclitaxel : 80 mg/m^2 by vein once weekly over 1 hour on day 1(+/- 2 days) each week for 3 weeks and for 12 cycles.~Cyclophosphamide : 500 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles.~Epirubicin : 100 mg/m^2 by vein on day 1 every 3 weeks (+/- 7 days) for 4 cycles."
446549|NCT00499590|B4|Baseline|Total|Total of all reporting groups
446550|NCT00499590|B3|Baseline|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446551|NCT00499590|B2|Baseline|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446552|NCT00499590|B1|Baseline|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
446553|NCT00499590|P3|Participant Flow|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446554|NCT00499590|P2|Participant Flow|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446555|NCT00499590|P1|Participant Flow|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
446556|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446557|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446558|NCT00499590|O1|Outcome|Lucentis|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
446559|NCT00499590|O3|Outcome|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446560|NCT00499590|O2|Outcome|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446561|NCT00499590|O1|Outcome|Lucentis®|"Lucentis® (0.5mg) every 4 weeks.~ranibizumab: Lucentis® (0.5 mg)administered intravitreally every 4 weeks."
446562|NCT00499590|E3|Reported Event|Bevasiranib 12 Weeks|"Bevasiranib (2.5mg) every 12 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446563|NCT00499590|E2|Reported Event|Bevasiranib 8 Weeks|"Bevasiranib (2.5mg) every 8 weeks beginning at week 12, after pre-treatment with 3 injections of Lucentis® and initial priming doses of bevasiranib at weeks 2 & 6.~bevasiranib: Bevasiranib (2.5mg) administered intravitreally every 8 or 12 weeks"
446569|NCT00499486|O1|Outcome|One Group|Patients with advanced pancreatic adenocarcinoma refractory to gemcitabine
446570|NCT00499486|E1|Reported Event|Sirolimus|Treatment with rapamycin will begin on Day 1 at a single flat dose level of 5 mg/day. Rapamycin will be administered continuously without interruption through all cycles in an outpatient setting. Each cycle will last 28 days.
446571|NCT00499473|B3|Baseline|Total|Total of all reporting groups
446572|NCT00499473|B2|Baseline|Stratum 2: Patients on EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446573|NCT00499473|B1|Baseline|Stratum I: Patients Not on EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446574|NCT00499473|P2|Participant Flow|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446575|NCT00499473|P1|Participant Flow|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446576|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446577|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446578|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446579|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446580|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446581|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446582|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446583|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446584|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446585|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446586|NCT00499473|O2|Outcome|Stratum 2: EIAC|The first six patients enrolled on stratum 2 will be dosed identical to those patients on stratum 1.The dosage of the next 6-patient cohort in stratum 2 will be adjusted to that predicted by pharmacokinetic modeling to provide the same concentrations seen in first six non-enzyme inducing patients.
446587|NCT00499473|O1|Outcome|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446588|NCT00499473|E2|Reported Event|Stratum 2: EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib. In addition to EIAC (Enzyme-inducing anticonvulsant)
446589|NCT00499473|E1|Reported Event|Stratum I: Non-EIAC|Patients will take one 50-mg capsule of sunitinib orally once daily for 4 consecutive weeks followed by 2 weeks of rest (drug holiday) with no sunitinib.
446590|NCT00499447|B1|Baseline|Radiofrequency Ablation Combined With External|
446591|NCT00499447|P1|Participant Flow|Radiofrequency Ablation Combined With External|
446592|NCT00499447|O1|Outcome|Radiofrequency Ablation Combined With External|
446593|NCT00499447|E1|Reported Event|Radiofrequency Ablation Combined With External|
446594|NCT00499408|B1|Baseline|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
446595|NCT00499408|P1|Participant Flow|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
446596|NCT00499408|O1|Outcome|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
446597|NCT00499408|E1|Reported Event|Vitamin D and Soy Supplementation|oral supplementation with both 2,000 international units per day of vitamin D (cholecalciferol) and soy (160 milligrams per day soy isoflavones)
446598|NCT00499369|B6|Baseline|Total|Total of all reporting groups
446599|NCT00499369|B5|Baseline|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446600|NCT00499369|B4|Baseline|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446601|NCT00499369|B3|Baseline|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446602|NCT00499369|B2|Baseline|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446603|NCT00499369|B1|Baseline|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446604|NCT00499369|P5|Participant Flow|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446605|NCT00499369|P4|Participant Flow|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446606|NCT00499369|P3|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446607|NCT00499369|P2|Participant Flow|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446608|NCT00499369|P1|Participant Flow|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446609|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446610|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446611|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446612|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446613|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446614|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446615|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446616|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446617|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446618|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446619|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446620|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446621|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446622|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446623|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446624|NCT00499369|O5|Outcome|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446625|NCT00499369|O4|Outcome|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446626|NCT00499369|O3|Outcome|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446627|NCT00499369|O2|Outcome|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446628|NCT00499369|O1|Outcome|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446629|NCT00499369|E5|Reported Event|Cohort II: Chemotherapy + Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446630|NCT00499369|E4|Reported Event|Cohort II: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446631|NCT00499369|E3|Reported Event|Cohort I: Chemotherapy + Cetuximab + Higher Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a higher dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446632|NCT00499369|E2|Reported Event|Cohort I: Chemotherapy + Cetuximab + Lower Bevacizumab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV, cetuximab IV over 1-2 hours, and a lower dose of bevacizumab IV over 30 minutes on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446633|NCT00499369|E1|Reported Event|Cohort I: Chemotherapy + Cetuximab|Single-agent irinotecan hydrochloride IV or FOLFIRI IV and cetuximab IV over 1-2 hours on day 1. Courses repeat every 14-21 days (depending upon chemotherapy regimen)
446634|NCT00499343|B3|Baseline|Total|Total of all reporting groups
446635|NCT00499343|B2|Baseline|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
446636|NCT00499343|B1|Baseline|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
446637|NCT00499343|P2|Participant Flow|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
446638|NCT00499343|P1|Participant Flow|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
446639|NCT00499343|O2|Outcome|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
446640|NCT00499343|O1|Outcome|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
446641|NCT00499343|E2|Reported Event|Rituximab + Ifosfamide + Etoposide + 1 Growth Factor|Growth Factor = granulocyte-colony stimulating factor (G-CSF)
446642|NCT00499343|E1|Reported Event|Rituximab + Ifosfamide + Etoposide + 2 Growth Factors|Growth Factors = granulocyte-colony stimulating factor (G-CSF) + granulocyte macrophage-colony stimulating factor (GM-CSF)
446643|NCT00499252|B1|Baseline|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446644|NCT00499252|P1|Participant Flow|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446645|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446646|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446647|NCT00499252|O1|Outcome|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446648|NCT00499252|E1|Reported Event|Abraxane®|Abraxane® 100 mg/m2 infused I.V. over 30 minutes weekly on days 1, 8, and 15 every 28 days until disease progression or adverse effects prohibit further therapy.
446649|NCT00499122|B1|Baseline|NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel|"Cyclophosphamide :~Doxorubicin hydrochloride :~conventional surgery :~Docetaxel :~Glutathione disulfide NOV-002 :"
446650|NCT00499122|P1|Participant Flow|NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel|"Cyclophosphamide :~Doxorubicin hydrochloride :~conventional surgery :~Docetaxel :~Glutathione disulfide NOV-002 :"
446651|NCT00499122|O1|Outcome|NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel|"Cyclophosphamide :~Doxorubicin hydrochloride :~conventional surgery :~Docetaxel :~Glutathione disulfide NOV-002 :"
446652|NCT00499122|E1|Reported Event|NOV-002 and Doxorubicin, Cyclophosphamide and Docetaxel|"Cyclophosphamide :~Doxorubicin hydrochloride :~conventional surgery :~Docetaxel :~Glutathione disulfide NOV-002 :"
446653|NCT00499109|B3|Baseline|Total|Total of all reporting groups
446654|NCT00499109|B2|Baseline|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
446655|NCT00499109|B1|Baseline|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
446656|NCT00499109|P2|Participant Flow|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
446657|NCT00499109|P1|Participant Flow|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
446658|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
446719|NCT00498797|E1|Reported Event|Vandetanib|docetaxel/prednisolone/vandetanib
446720|NCT00498706|B3|Baseline|Total|Total of all reporting groups
446659|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
446660|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
446661|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
446662|NCT00499109|O2|Outcome|C. Standard of Care Control Arm|"Control Arm C: Gemcitabine and Carboplatin (GCb).~All patients in arm C were treated with GCb regardless of gene expression levels. Patients received up to 6 cycles, and no maintenance therapy was allowed."
446663|NCT00499109|O1|Outcome|E. Dual Agent Chemotherapy|"Experimental Arm E.~Patients received treatment according to gene expression strata with four doublet regimens.~Low ERCC1 and Low RRM1 Group - Gemcitabine (G) and Carboplatin (Cb): GCb Group.~Low RRM1 and High ERCC1 Group - Gemcitabine (G) and Docetaxel (D): GD Group.~High RRM1 and Low ERCC1 Group - Docetaxel (D) and Carboplatin (Cb): DCb Group.~High ERCC1 and High RRM1 Group - Vinorelbine (V) and Docetaxel (D): DV Group."
446664|NCT00499109|E5|Reported Event|Control: C|Gemcitabine/Carboplatin
446665|NCT00499109|E4|Reported Event|Experimental: E4|Gemcitabine/Carboplatin
446666|NCT00499109|E3|Reported Event|Experimental: E3|Gemcitabine/Docetaxel
446667|NCT00499109|E2|Reported Event|Experimental: E2|Docetaxel/Carboplatin
446668|NCT00499109|E1|Reported Event|Experimental: E1|Docetaxel/Vinorelbine
446669|NCT00499096|B3|Baseline|Total|Total of all reporting groups
446670|NCT00499096|B2|Baseline|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease (CVD) will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446671|NCT00499096|B1|Baseline|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease (CVD); group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446672|NCT00499096|P2|Participant Flow|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446673|NCT00499096|P1|Participant Flow|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446674|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446675|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446676|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446677|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446678|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
453506|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
446679|NCT00499096|O1|Outcome|Chonic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446680|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446681|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446682|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446683|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446684|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446685|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager. This is the chronic care model for bipolar disorder~Chronic care model for Bipolar Disorder: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446686|NCT00499096|O2|Outcome|Enhanced Usual Care|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446687|NCT00499096|O1|Outcome|Chronic Care Model for Bipolar Disorder|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446688|NCT00499096|E2|Reported Event|Arm 2|A group of patients with bipolar disorder and one or more risk factors for cardiovascular disease will be randomized to receive enhanced usual care. This group will receive usual care, plus mailings on wellness topics (attention control), and their providers will receive information on guideline concordant care.
446689|NCT00499096|E1|Reported Event|Arm 1|"An intervention group of patients with bipolar disorder and 1 or more risk factor for cardiovascular disease; group will receive self-management group sessions, followed by phone contacts by the Care Manager.~Chronic care model involving self-management educational sessions, care management for up to 1 year, and guideline dissemination: The behavioral intervention is based on the Chronic Care Model (CCM) where patients receive information on managing bipolar symptoms and health habits in a group self-management session (up to 6 weekly sessions). The Care Manager then follows up with patients via phone contacts for 12 months following the intervention. The providers receive information on guidelines for care."
446690|NCT00499031|B1|Baseline|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
446691|NCT00499031|P1|Participant Flow|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
446692|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
446693|NCT00499031|O1|Outcome|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
453507|NCT00479336|E4|Reported Event|OPC-41061 30 mg|30 mg, 1 tablet a day
446694|NCT00499031|E1|Reported Event|Treatment (Cetuximab)|Day 1: 400 mg/m2 loading dose of cetuximab IV over 120 minutes; Day 8 and weekly thereafter: 250 mg/m2 cetuximab IV over 60 minutes (one cycle = four weeks) until disease progression or adverse effects prohibit further therapy
446695|NCT00498940|B3|Baseline|Total|Total of all reporting groups
446696|NCT00498940|B2|Baseline|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
446697|NCT00498940|B1|Baseline|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
446698|NCT00498940|P2|Participant Flow|Standard of Care|"No post operative pacing is to occur. Patients will undergo optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass."
446699|NCT00498940|P1|Participant Flow|Biventricular Pacing|"After weaning from bypass, patients will receive temporary biventricular pacing for 24 hours. Values obtained from optimization testing will determine pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and heart rate were optimized after weaning off bypass (phase I), after sternal closure (phase II), and 12 to 24 hours (phase III) after bypass.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours."
446700|NCT00498940|O2|Outcome|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
446701|NCT00498940|O1|Outcome|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
446702|NCT00498940|E2|Reported Event|Standard of Care|"No continuous pacing occurred about surgery. Patients underwent optimization testing.~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III."
446703|NCT00498940|E1|Reported Event|Biventricular Pacing|"After weaning from bypass, patients received temporary biventricular pacing for 24 hours. Values obtained from optimization testing determined pacemaker settings (AVD, VVD, heart rate).~Optimization Testing: Atrioventricular (AVD) and interventricular (VVD) delays and left ventricle lead site location were optimized after weaning off bypass (Phase I), after sternal closure (Phase II), and 12 to 24 hours (Phase III) after bypass. Intrinsic heart rate was also optimized in Phase III.~Temporary Biventricular Pacing: Continuous temporary biventricular pacing for 24 hours at a heart rate of 90 bpm or 10 bpm above intrinsic heart rate."
446704|NCT00498927|B1|Baseline|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
446705|NCT00498927|P1|Participant Flow|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
446706|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
446707|NCT00498927|O1|Outcome|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
446708|NCT00498927|E1|Reported Event|Temozolomide|Following diagnosis of tumor recurrence or progression, all patients will receive of daily low dose temozolomide given at 50mg/m2/d without interruption. Brain imaging will be performed at baseline and every 2 months (standard of care). The treatment will be administered until development of toxicity, evidence of progression of disease or death.
446709|NCT00498797|B3|Baseline|Total|Total of all reporting groups
446710|NCT00498797|B2|Baseline|Placebo|docetaxel/prednisolone/placebo
446711|NCT00498797|B1|Baseline|Vandetanib|docetaxel/prednisolone/vandetanib
446712|NCT00498797|P2|Participant Flow|Placebo|docetaxel/prednisolone/placebo
446713|NCT00498797|P1|Participant Flow|Vandetanib|docetaxel/prednisolone/vandetanib
446714|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
446715|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
446716|NCT00498797|O2|Outcome|Placebo|docetaxel/prednisolone/placebo
446717|NCT00498797|O1|Outcome|Vandetanib|docetaxel/prednisolone/vandetanib
446718|NCT00498797|E2|Reported Event|Placebo|docetaxel/prednisolone/placebo
446721|NCT00498706|B2|Baseline|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446722|NCT00498706|B1|Baseline|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446723|NCT00498706|P2|Participant Flow|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446724|NCT00498706|P1|Participant Flow|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446725|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446726|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446727|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446728|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446729|NCT00498706|O2|Outcome|Face-to-face Cognitive Behavioral Therapy|Participants will receive face-to-face cognitive behavioral therapy.
446730|NCT00498706|O1|Outcome|Telephone-administered Cognitive Behavioral Therapy|Participants will receive telephone-administered cognitive behavioral therapy.
446731|NCT00498706|O2|Outcome|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446732|NCT00498706|O1|Outcome|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446733|NCT00498706|E2|Reported Event|Face-to-face CBT|Participants will receive face-to-face cognitive behavioral therapy.
446734|NCT00498706|E1|Reported Event|Telephone-administered CBT|Participants will receive telephone-administered cognitive behavioral therapy.
446735|NCT00498628|B3|Baseline|Total|Total of all reporting groups
446736|NCT00498628|B2|Baseline|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
446737|NCT00498628|B1|Baseline|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
446738|NCT00498628|P2|Participant Flow|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
446739|NCT00498628|P1|Participant Flow|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
446740|NCT00498628|O2|Outcome|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
446741|NCT00498628|O1|Outcome|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
446742|NCT00498628|E2|Reported Event|Sugar Pill Plus Medical Management|Medical management plus placebo comparator
446743|NCT00498628|E1|Reported Event|Quetiapine Fumerate Plus Medical Management|Quetiapine fumarate - target dose 400mg/day plus medical management
446744|NCT00498615|B1|Baseline|3 Period Crossover Study ( All Participants)|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil (40 mg or 80 mg) or placebo administered 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of RP secondary to SSc were eligible for the study."
446745|NCT00498615|P6|Participant Flow|Sequence 6|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
446746|NCT00498615|P5|Participant Flow|Sequence 5|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
446747|NCT00498615|P4|Participant Flow|Sequence 4|Subjects received a single dose of placebo at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of Fasudil 80 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
446748|NCT00498615|P3|Participant Flow|Sequence 3|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of placebo and at treatment period 3 they received a single dose of Fasudil 40 mg. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
446749|NCT00498615|P2|Participant Flow|Sequence 2|Subjects received a single dose of Fasudil 40 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 80 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods
446750|NCT00498615|P1|Participant Flow|Sequence 1|Subjects received a single dose of Fasudil 80 mg at treatment period 1. At treatment period 2 they will received a single dose of Fasudil 40 mg and at treatment period 3 they received a single dose of placebo. A washout interval of at least 24 hours and no more than 7 days will be maintained between treatment periods.
446751|NCT00498615|O3|Outcome|Placebo|"Time to reach 70% of skin temperature after cold challenge done 2 hrs after taking placebo~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
446782|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446783|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446930|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
453508|NCT00479336|E3|Reported Event|OPC-41061 15 mg|15 mg, 1 tablet a day
446752|NCT00498615|O2|Outcome|40 mg Fasudil|"Time to reach 70% skin temperature after cold challenge done 2 hrs after dosing.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
446753|NCT00498615|O1|Outcome|Fasudil 80 mg|"Time to recover 70% of baseline skin temperature after cold challenge done 2 hrs after dose.~Fasudil: Each subject will be randomly assigned to 1 of 6 possible treatment sequences (ABC, ACB, BAC, BCA, CAB, and CBA) in a double-blind manner: A- a single oral dose of 2 placebo tablets; B- a single, oral 40 mg Fasudil dose as one 40 mg tablet and 1 placebo tablet; C- a single oral 80 mg dose as two 40 mg Fasudil tablets. Subjects will be randomized at the screening/baseline visit to a specific treatment sequence based upon a computer generated code on a 1:1:1:1:1:1 ratio for the 6 possible treatments. A single dose consisting of the two tablets will be taken after fasting for 10 hours once during each treatment period. A washout interval of at least 72 hours and no more than 7 days will be maintained between treatment periods. Concomitant medications will not be taken during the study session."
446754|NCT00498615|O3|Outcome|Placebo|In this group participants received placebo 2 hours before cold challenge.
446755|NCT00498615|O2|Outcome|40 mg Fasudil|In this group participants received 40mg of Fasudil 2 hours before cold challenge
446756|NCT00498615|O1|Outcome|80 mg Fasudil|"This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil In this arm participants received 80 mg of Fasudil 2 hours before a standardized cold challenge.~Men and women between ages 18–80 years with a clinical diagnosis of Raynauds Phenomenon secondary to Scleroderma were eligible for the study."
446757|NCT00498615|O3|Outcome|Placebo|participants will receive placebo at 1 of 3 study periods. participants and researchers will not know which is received.
446758|NCT00498615|O2|Outcome|80 mg Fasudil|participants will receive 80mg of Fasudil at 1 one 3 study periods 2hrs before a cold challenge.
446759|NCT00498615|O1|Outcome|40 mg Fasudil|This is a single-center, double-blind, placebo-controlled, randomized, 3-period crossover study of oral fasudil 40 mg administered 2 hours before a standardized cold challenge participant and researchers will not know what is received on the testing day.
446760|NCT00498615|E3|Reported Event|80mg Fasudil|80mg Fasudil was administered 2 hours before a standardized cold challenge.
446761|NCT00498615|E2|Reported Event|40 mg Fasudil|40 mg Fasudil was administered 2 hours before a standardized cold challenge.
446762|NCT00498615|E1|Reported Event|Placebo|Placebo was administered 2 hours before a standardized cold challenge.
446763|NCT00498602|B8|Baseline|Total|Total of all reporting groups
446764|NCT00498602|B7|Baseline|Phosphate Buffered Saline|Participants received PBS. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446765|NCT00498602|B6|Baseline|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446766|NCT00498602|B5|Baseline|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446767|NCT00498602|B4|Baseline|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446768|NCT00498602|B3|Baseline|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446769|NCT00498602|B2|Baseline|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446770|NCT00498602|B1|Baseline|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446771|NCT00498602|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446772|NCT00498602|P6|Participant Flow|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446773|NCT00498602|P5|Participant Flow|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446774|NCT00498602|P4|Participant Flow|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446775|NCT00498602|P3|Participant Flow|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446776|NCT00498602|P2|Participant Flow|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446777|NCT00498602|P1|Participant Flow|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446778|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446779|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446780|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446781|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446784|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446785|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446786|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446787|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446788|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446789|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446790|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446791|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446792|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446793|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446794|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446795|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446796|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446797|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446798|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446799|NCT00498602|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446800|NCT00498602|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446801|NCT00498602|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446802|NCT00498602|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446803|NCT00498602|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446804|NCT00498602|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446805|NCT00498602|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446806|NCT00498602|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446807|NCT00498602|E6|Reported Event|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446808|NCT00498602|E5|Reported Event|ACC 30 μg|Participants received 30 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446809|NCT00498602|E4|Reported Event|ACC 10 μg|Participants received 10 μg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446810|NCT00498602|E3|Reported Event|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446811|NCT00498602|E2|Reported Event|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446812|NCT00498602|E1|Reported Event|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
446813|NCT00498550|B3|Baseline|Total|Total of all reporting groups
446814|NCT00498550|B2|Baseline|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
446815|NCT00498550|B1|Baseline|Clozapine|Clozapine, Clozaril
446816|NCT00498550|P2|Participant Flow|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
446817|NCT00498550|P1|Participant Flow|Clozapine|Clozapine, Clozaril
446818|NCT00498550|O2|Outcome|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
446819|NCT00498550|O1|Outcome|Clozapine|Clozapine, Clozaril
446820|NCT00498550|E2|Reported Event|Treatment as Usual|Treatment as usual with any antipsychotic other than Clozapine.
446821|NCT00498550|E1|Reported Event|Clozapine|Clozapine, Clozaril
446822|NCT00498485|B3|Baseline|Total|Total of all reporting groups
446823|NCT00498485|B2|Baseline|Xyrem|Xyrem: Same as for Placebo
446824|NCT00498485|B1|Baseline|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
446825|NCT00498485|P2|Participant Flow|Xyrem|Xyrem: Same as for Placebo
446826|NCT00498485|P1|Participant Flow|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
446827|NCT00498485|O2|Outcome|Xyrem|Xyrem: Same as for Placebo
446828|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
446829|NCT00498485|O2|Outcome|Drug Treated|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
446830|NCT00498485|O1|Outcome|Placebo|Xyrem: Volunteers will complete questionnaires. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved.
446831|NCT00498485|E2|Reported Event|Xyrem|Xyrem: Same as for Placebo
446832|NCT00498485|E1|Reported Event|Placebo|Xyrem: Volunteers will complete questionnaires about their symptoms and a computerized test to assess their degree of brain fog. They will be randomly assigned to one of two groups, placebo or drug. Volunteers will know what group they are in at end of the study. Only the drug group will receive the medication. The placebo group will receive a substance that looks like the real medicine but with no active ingredients. The medication comes as a liquid and patients will start taking an initial dose about 30 min before they expect to sleep. If subjects awaken after less than 5 hrs of sleep, they will take a second dose. If they sleep more than 5 hrs, they will skip the second dose. We will call patients weekly to see how they are doing . If they have tolerable side effects or report significant improvement, we will maintain the dose. But if patients report no effect, the dosage will be incremented by 1 ml per week until good sleep is achieved or a predeterm
446833|NCT00498433|B4|Baseline|Total|Total of all reporting groups
446834|NCT00498433|B3|Baseline|Part 2, Double Blind: Amlodipine|Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446835|NCT00498433|B2|Baseline|Part 2, Double Blind Period: Aliskiren|Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446836|NCT00498433|B1|Baseline|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446837|NCT00498433|P3|Participant Flow|Amlodipine|"Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.~Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks"
446838|NCT00498433|P2|Participant Flow|Aliskiren|"Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks"
446928|NCT00497796|P1|Participant Flow|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446929|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446839|NCT00498433|P1|Participant Flow|Placebo|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 2, Period 1: After confirming study eligibility based on inclusion and exclusion criteria, patients underwent a two week single-blind placebo run-in phase."
446840|NCT00498433|O3|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446841|NCT00498433|O2|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446842|NCT00498433|O1|Outcome|Placebo run-in|Part 2, Period 1, Placebo run-in phase: After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
446843|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446844|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446845|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446846|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446847|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446848|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446849|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446850|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446851|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446852|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446853|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446854|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446855|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446856|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446857|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446858|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446859|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446860|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446861|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446862|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446863|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446864|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
447093|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
446865|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446866|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446867|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446868|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446869|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446870|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446871|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446872|NCT00498433|O2|Outcome|Amlodipine|Part 2, Double Blind Period: Eligible randomized patients received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446873|NCT00498433|O1|Outcome|Aliskiren|Part 2, Double Blind Period: Eligible randomized patients received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446874|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446875|NCT00498433|O1|Outcome|Part 1: Placebo/Aliskiren/Amlodipine|"Part 1, Period 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase.~Part 1 , Period 2: All eligible patients received 4 week treatment of 300 mg aliskiren o.d..~Part 1, Period 3: All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks."
446876|NCT00498433|E5|Reported Event|Part 2: Amlodipine|Double Blind Period: Eligible randomized patients of this arm received amlodipine 5 mg o.d. and aliskiren placebo o.d. for 12 weeks
446877|NCT00498433|E4|Reported Event|Part 2: Aliskiren|Eligible randomized patients of this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks
446878|NCT00498433|E3|Reported Event|Part 2: Placebo run-in Period|After confirming study eligibility based on inclusion and exclusion criteria, patients will undergo a two week single-blind placebo run-in phase.
446879|NCT00498433|E2|Reported Event|Part 1: Amlodipine|All patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks.
446880|NCT00498433|E1|Reported Event|Part 1: Aliskiren|All eligible patients received 4 week treatment of 300 mg aliskiren o.d..
446881|NCT00498368|B3|Baseline|Total|Total of all reporting groups
446882|NCT00498368|B2|Baseline|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446883|NCT00498368|B1|Baseline|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An ACE inhibitors and /or ARBs will be used to achieve a blood pressure goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446884|NCT00498368|P2|Participant Flow|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446885|NCT00498368|P1|Participant Flow|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446886|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446887|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446888|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
447094|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
446889|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446890|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446891|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446892|NCT00498368|O2|Outcome|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446893|NCT00498368|O1|Outcome|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446894|NCT00498368|E2|Reported Event|ACE/ARB|"ACE/ARB therapy and Omega-3 Fatty Acid Fish Oil Supplement~ACE/ARB: ACE inhibitors and /or ARBs will be used to achieve a B/P goal of <130/80 millimeters of mercury (mmHg)~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446895|NCT00498368|E1|Reported Event|Rituximab Plus ACE/ARB|"Intravenous Rituximab therapy, ACE/ARB combination therapy, and Omega-3 Fatty Acid Fish Oil Supplement~Intravenous Rituximab: Rituximab Therapy [27 Patients]~Rituximab 1 gm IV on Treatment Day 1~Rituximab 1 gm IV on Treatment Day 15~Rituximab 1 gm IV on Treatment Day 168~Rituximab 1 gm IV on Treatment Day 182~An angiotensin converting enzyme (ACE) inhibitors and /or angiotensin II receptor blockers (ARBs) will be used to achieve a B/P goal of <130/80 millimeters of mercury~Omega-3 Fatty Acid Fish Oil Supplement: Omega-3 Fatty Acid Fish Oil Supplement 3.6 gm eicosapentaenoic acid (EPA)/day"
446896|NCT00498355|B1|Baseline|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
446897|NCT00498355|P1|Participant Flow|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
446898|NCT00498355|O1|Outcome|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
446899|NCT00498355|E1|Reported Event|Ranibizumab for Macular Edema|This study was an open-label, single-center, prospective, nonrandomized interventional case series of 7 eyes in 7 patients with controlled uveitis and persistent visually significant macular edema.
446900|NCT00498186|B1|Baseline|Rotigotine|Rotigotine trans-dermal patch
446901|NCT00498186|P1|Participant Flow|Rotigotine|Rotigotine trans-dermal patch
446902|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
446903|NCT00498186|O1|Outcome|Rotigotine|Rotigotine trans-dermal patch
446904|NCT00498186|E1|Reported Event|Rotigotine|Rotigotine trans-dermal patch
446905|NCT00497874|B3|Baseline|Total|Total of all reporting groups
446906|NCT00497874|B2|Baseline|Usual Care|Usual primary care treatment
446907|NCT00497874|B1|Baseline|Intervention|Stage-based manual and three computer-tailored reports
446908|NCT00497874|P2|Participant Flow|Usual Care|Usual primary care treatment
446909|NCT00497874|P1|Participant Flow|Intervention|Stage-based manual and three computer-tailored reports
446910|NCT00497874|O2|Outcome|Usual Care|Usual primary care
446911|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
446912|NCT00497874|O2|Outcome|Usual Care|Usual primary care
446913|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
446914|NCT00497874|O2|Outcome|Usual Care|Usual primary care
446915|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
446916|NCT00497874|O2|Outcome|Usual Care|Usual primary care
446917|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
446918|NCT00497874|O2|Outcome|Usual Care|Usual primary care treatment
446919|NCT00497874|O1|Outcome|Intervention|Stage-based manual and three computer-tailored reports
446920|NCT00497874|O2|Outcome|Usual Care|Usual primary care
446921|NCT00497874|O1|Outcome|Intervention|Usual primary care + computer-tailored intervention
446922|NCT00497874|E2|Reported Event|Usual Care|Usual primary care treatment
446923|NCT00497874|E1|Reported Event|Intervention|Stage-based manual and three computer-tailored reports
446924|NCT00497796|B3|Baseline|Total|Total of all reporting groups
446925|NCT00497796|B2|Baseline|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446926|NCT00497796|B1|Baseline|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446927|NCT00497796|P2|Participant Flow|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446931|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446932|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446933|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446934|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446935|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446936|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446937|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446938|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446939|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446940|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446941|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446942|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446943|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446944|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446945|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446946|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446947|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446948|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446949|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446950|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446951|NCT00497796|O2|Outcome|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446952|NCT00497796|O1|Outcome|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446953|NCT00497796|E2|Reported Event|Ganciclovir 1000 mg TID|Ganciclovir: 1000mg three times per (TID) day for 14 weeks.
446954|NCT00497796|E1|Reported Event|Maribavir 100 mg BID|Maribavir: 100mg twice a day (BID) for 14 weeks.
446955|NCT00497770|B5|Baseline|Total|Total of all reporting groups
446956|NCT00497770|B4|Baseline|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446957|NCT00497770|B3|Baseline|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446958|NCT00497770|B2|Baseline|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446959|NCT00497770|B1|Baseline|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
446960|NCT00497770|P4|Participant Flow|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446961|NCT00497770|P3|Participant Flow|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446962|NCT00497770|P2|Participant Flow|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446963|NCT00497770|P1|Participant Flow|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
446964|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446965|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446966|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446967|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446968|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446969|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446970|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446971|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446972|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446973|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446974|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446975|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446976|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446977|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446978|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446979|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446980|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446981|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446982|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446983|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446984|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446985|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446986|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446987|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446988|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446989|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446990|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446991|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446992|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446993|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446994|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446995|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
446996|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
446997|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
446998|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
446999|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
447000|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
447001|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
447002|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
447003|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
447004|NCT00497770|O4|Outcome|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
447005|NCT00497770|O3|Outcome|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
447006|NCT00497770|O2|Outcome|African American|African American participants receiving pemetrexed for 2nd line NSCLC
447007|NCT00497770|O1|Outcome|Caucasian|Caucasian participants receiving pemetrexed for 2nd line NSCLC
447008|NCT00497770|E4|Reported Event|Hispanic|Hispanic participants receiving pemetrexed for 2nd line NSCLC
447009|NCT00497770|E3|Reported Event|Asian American|Asian American participants receiving pemetrexed for 2nd line NSCLC
447010|NCT00497770|E2|Reported Event|African American|African American participants receiving pemetrexed for 2nd line NSCLC
447011|NCT00497770|E1|Reported Event|Caucasian|Caucasian participants receiving pemetrexed for second (2nd) line non-small cell lung cancer (NSCLC)
447012|NCT00497198|B3|Baseline|Total|Total of all reporting groups
447013|NCT00497198|B2|Baseline|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447014|NCT00497198|B1|Baseline|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447015|NCT00497198|P2|Participant Flow|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447016|NCT00497198|P1|Participant Flow|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447017|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447018|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447019|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447020|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447021|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447022|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447023|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447024|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447025|NCT00497198|O2|Outcome|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447026|NCT00497198|O1|Outcome|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447027|NCT00497198|E2|Reported Event|Placebo|Three tablets of Placebo tablet at a time, three times daily, 12 weeks administration
447028|NCT00497198|E1|Reported Event|MCI-196|Three tablets of MCI-196 500mg tablet at a time, three times daily, 12 weeks administration (dose in a day: 4500mg)
447029|NCT00497146|B3|Baseline|Total|Total of all reporting groups
447030|NCT00497146|B2|Baseline|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447031|NCT00497146|B1|Baseline|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447032|NCT00497146|P2|Participant Flow|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447033|NCT00497146|P1|Participant Flow|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447034|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447095|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
447096|NCT00497055|E2|Reported Event|Placebo|placebo daily for 3 months
447035|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447036|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447037|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447038|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447039|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447040|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447041|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447042|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447043|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447044|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447045|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447046|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447047|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447048|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447049|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447050|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447051|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447052|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447053|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447054|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447055|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447097|NCT00497055|E1|Reported Event|Aripiprazole|aripiprazole daily for 3 months
447056|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447057|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447058|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447059|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447060|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447061|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447062|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447063|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447064|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447065|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447066|NCT00497146|O2|Outcome|Placebo|Participants received 2 placebo capsules once a day for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447067|NCT00497146|O1|Outcome|Paricalcitol|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks. Participants who completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447068|NCT00497146|E4|Reported Event|Placebo: Long-term Follow-up|Participants who received placebo and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447069|NCT00497146|E3|Reported Event|Paricalcitol: Long-term Follow-up|Participants who received paricalcitol and completed the 48-week Treatment Period could continue in the Long-term Follow-up Period for an additional 18 months. Participants did not receive study drug during the Long-term Follow-up Period.
447070|NCT00497146|E2|Reported Event|Placebo: Treatment Period|Participants received 2 placebo capsules once a day for up to 48 weeks.
447071|NCT00497146|E1|Reported Event|Paricalcitol: Treatment Period|Participants received paricalcitol capsules 2 µg once a day (two 1 µg paricalcitol capsules), for up to 48 weeks.
447072|NCT00497081|B3|Baseline|Total|Total of all reporting groups
447073|NCT00497081|B2|Baseline|Placebo Comparator:|placebo 30 mg daily for 3 months
447074|NCT00497081|B1|Baseline|Active Comparator:|mirtazapine 30 mg daily for 3 months
447075|NCT00497081|P2|Participant Flow|Placebo Comparator:|placebo 30 mg daily for 3 months
447076|NCT00497081|P1|Participant Flow|Active Comparator:|mirtazapine 30 mg daily for 3 months
447077|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
447078|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
447079|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
447080|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
447081|NCT00497081|O2|Outcome|Placebo Comparator:|placebo 30 mg daily for 3 months
447082|NCT00497081|O1|Outcome|Active Comparator:|mirtazapine 30 mg daily for 3 months
447083|NCT00497081|E2|Reported Event|Placebo Comparator:|placebo 30 mg daily for 3 months
447084|NCT00497081|E1|Reported Event|Active Comparator:|mirtazapine 30 mg daily for 3 months
447085|NCT00497055|B3|Baseline|Total|Total of all reporting groups
447086|NCT00497055|B2|Baseline|Placebo|placebo daily for 3 months
447087|NCT00497055|B1|Baseline|Aripiprazole|aripiprazole daily for 3 months
447088|NCT00497055|P2|Participant Flow|Placebo|Placebo (for Aripiprazole) 5mg daily for week one. Placebo (for Aripiprazole) 10mg daily for week two. Placebo (for Aripiprazole) 20mg daily for weeks three through twelve.
447089|NCT00497055|P1|Participant Flow|Aripiprazole|Aripiprazole 5mg daily for week one. Aripiprazole 10mg daily for week two. Aripiprazole 20mg daily for weeks three through twelve.
447090|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
447091|NCT00497055|O1|Outcome|Aripiprazole|aripiprazole daily for 3 months
447092|NCT00497055|O2|Outcome|Placebo|placebo daily for 3 months
447099|NCT00496964|B2|Baseline|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
447100|NCT00496964|B1|Baseline|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
447101|NCT00496964|P2|Participant Flow|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
447102|NCT00496964|P1|Participant Flow|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
447103|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
447104|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
447105|NCT00496964|O2|Outcome|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
447106|NCT00496964|O1|Outcome|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
447107|NCT00496964|E2|Reported Event|Placebo Injection + Exercise|Placebo injection into Vastus Lateralis + exercise
447108|NCT00496964|E1|Reported Event|Botulinum Toxin A Injection + Exercise|Injection of Botulinum toxin A into vastus lateralis of study limb plus exercise program
447109|NCT00496873|B1|Baseline|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447110|NCT00496873|P1|Participant Flow|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447111|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447112|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447113|NCT00496873|O1|Outcome|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447114|NCT00496873|E1|Reported Event|Cytoxan + Rituxan + Nipent|Cytoxan 600 mg/m^2, Rituxan 375 mg/m^2 and Nipent 4 mg/m^2 on Day 1 of 21 Day Cycle.
447115|NCT00496860|B4|Baseline|Total|Total of all reporting groups
447116|NCT00496860|B3|Baseline|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447117|NCT00496860|B2|Baseline|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447118|NCT00496860|B1|Baseline|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447119|NCT00496860|P3|Participant Flow|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447120|NCT00496860|P2|Participant Flow|ALT-801 0.040 mg/kg/ Dose|0.040 mg/kg/dose of ALT-801
447121|NCT00496860|P1|Participant Flow|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447122|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447123|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447124|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447125|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447126|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447127|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447128|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447129|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447130|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447131|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447132|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447133|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447134|NCT00496860|O3|Outcome|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447135|NCT00496860|O2|Outcome|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447136|NCT00496860|O1|Outcome|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447137|NCT00496860|E3|Reported Event|ALT-801 0.080 mg/kg/Dose|0.080 mg/kg/dose of ALT-801
447138|NCT00496860|E2|Reported Event|ALT-801 0.040 mg/kg/Dose|0.040 mg/kg/dose of ALT-801
447139|NCT00496860|E1|Reported Event|ALT-801 0.015 mg/kg/Dose|0.015 mg/kg/dose of ALT-801
447140|NCT00496834|B3|Baseline|Total|Total of all reporting groups
447141|NCT00496834|B2|Baseline|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
447142|NCT00496834|B1|Baseline|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
447143|NCT00496834|P2|Participant Flow|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan)."
447144|NCT00496834|P1|Participant Flow|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan).
447161|NCT00496782|B2|Baseline|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447283|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447145|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
447146|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
447147|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
447148|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
447149|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation."
447150|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration 4) did not commit major violation and 5) did not have protocol violation including erroneous prescription of the investigational drug, baseline PWV test date violation, PWV test date violation 24 weeks after the administration of the investigational drug, titration violation, use of prohibited concomitant drugs, visit window violation and inclusion/exclusion criteria violation.
447151|NCT00496834|O2|Outcome|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation."
447152|NCT00496834|O1|Outcome|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Patients who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who 1) had baseline measurements before randomization, 2) had taken the study drug more than once after randomization, 3) had one measurement after the initiation of the administration and 4) did not commit major violation.
447153|NCT00496834|E2|Reported Event|Carvedilol|"Once daily, Dilatrend Tab® (carvedilol) 12.5 mg, Dilatrend Tab® (carvedilol) 25 mg, Dilatrend Tab® (carvedilol) 25 mg plus half Dichlozid Tab® (hydrochlorothiazide 25 mg) or~Dilatrend Tab® (carvedilol) 25 mg plus full Dichlozid Tab® (hydrochlorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once."
447154|NCT00496834|E1|Reported Event|Losartan|Once daily , Cozaar® (losartan) 50 mg, Cozaar® (losartan) 100 mg, Cozaar Plus®-pro Tab. (losartan 100 mg / hydrochrolorothiazide 12.5 mg) or Cozaar Plus®-F Tab. (losartan 100 mg / hydrochrolorothiazide 25 mg), 24 weeks (Subjects who have failed in blood pressure control, increase the study medication dose step by step according to the titration plan) and patients who received the investigational drug at least more than once.
447155|NCT00496808|B1|Baseline|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
447156|NCT00496808|P1|Participant Flow|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
447157|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
447158|NCT00496808|O1|Outcome|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
447159|NCT00496808|E1|Reported Event|Herceptin|8 mg/kg intravenously (IV) Over 90 Minutes
447160|NCT00496782|B3|Baseline|Total|Total of all reporting groups
447976|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447162|NCT00496782|B1|Baseline|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447163|NCT00496782|P2|Participant Flow|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447164|NCT00496782|P1|Participant Flow|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447165|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447166|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447167|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447168|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447169|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447170|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447171|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447172|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447173|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447174|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447175|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447210|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion
447284|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447176|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447177|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447178|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447179|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447180|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447181|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447182|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447183|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447184|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447185|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447186|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447187|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447188|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447189|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447247|NCT00496626|E1|Reported Event|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447977|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447190|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447191|NCT00496782|O2|Outcome|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447192|NCT00496782|O1|Outcome|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447193|NCT00496782|E2|Reported Event|Non-CCR5-Tropic HIV-1|Subjects treated with maraviroc (dosed orally twice daily (BID)) in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects with non CCR5 HIV 1 or a non reportable Trofile™ assay at Screening had discontinued maraviroc and had a new OBT selected by the investigator until End of Study.
447194|NCT00496782|E1|Reported Event|CCR5-Tropic HIV-1|Subjects treated with maraviroc in addition to the antiviral regimen they were receiving at the time of Screening (which was a failing regimen) for 14 days (including Day 14). On Day 15, subjects who had CC chemokine receptor 5 (CCR5) human immunodeficiency virus (HIV) 1 (based on Trofile™ assay) continued receiving maraviroc in combination with a new optimized background therapy (OBT) selected by the investigator until End of Study; Maraviroc was dosed orally twice daily (BID) with the total dose adjusted according to the OBT drugs.
447195|NCT00496769|B3|Baseline|Total|Total of all reporting groups
447196|NCT00496769|B2|Baseline|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447197|NCT00496769|B1|Baseline|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447198|NCT00496769|P2|Participant Flow|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447199|NCT00496769|P1|Participant Flow|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447200|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447201|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447202|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
447203|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447204|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
447205|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447206|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
447207|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447208|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
447209|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
453838|NCT00477269|O1|Outcome|STI571|STI571
447211|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447212|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447213|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447214|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once, with dosage based on investigator discretion.
447215|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447216|NCT00496769|O2|Outcome|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447217|NCT00496769|O1|Outcome|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447218|NCT00496769|E2|Reported Event|Acetylsalicylic Acid, 81-324 mg Once Daily|Patients received 81 to 324 mg of acetylsalicylic acid once daily, with dosage based on investigator discretion
447219|NCT00496769|E1|Reported Event|Apixaban, 2.5 or 5 mg Twice Daily|Patients received 5 mg of apixaban twice daily. Participants who fulfilled any 2 of the following criteria at baseline received apixaban, 2.5 mg twice daily: age older than 80 years, body weight of 60 kg or less, Serum creatinine level ≥1.5 mg/dL. Participants randomized to the 2.5 mg twice daily dose of apixaban continued on this dose throughout the study even if they no longer fulfilled the previous criteria.
447220|NCT00496730|B3|Baseline|Total|Total of all reporting groups
447221|NCT00496730|B2|Baseline|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447222|NCT00496730|B1|Baseline|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447223|NCT00496730|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447224|NCT00496730|P1|Participant Flow|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447225|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447226|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447227|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447228|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447229|NCT00496730|O2|Outcome|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447230|NCT00496730|O1|Outcome|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447231|NCT00496730|E2|Reported Event|Atorvastatin|atorvastatin 10 mg; tablet, once daily, 8 Weeks
447232|NCT00496730|E1|Reported Event|Vytorin|simvastatin (+) ezetimibe 10/20 mg (Vytorin®) ; tablet, once daily, 8 Weeks
447233|NCT00496626|B3|Baseline|Total|Total of all reporting groups
447234|NCT00496626|B2|Baseline|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447235|NCT00496626|B1|Baseline|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447236|NCT00496626|P2|Participant Flow|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447237|NCT00496626|P1|Participant Flow|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447238|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447239|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447240|NCT00496626|O2|Outcome|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447241|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447242|NCT00496626|O4|Outcome|Placebo Group (Month 7)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447243|NCT00496626|O3|Outcome|Vaccine (Gardasil®) Group (Month 7)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447244|NCT00496626|O2|Outcome|Placebo Group (Day 1)|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447245|NCT00496626|O1|Outcome|Vaccine (Gardasil®) Group (Day 1)|Human Papillomavirus (HPV) (Type 6, 11, 16, 18) Recombinant Vaccine (Gardasil®), 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447246|NCT00496626|E2|Reported Event|Placebo Group|Placebo aluminum-containing, 0.5mL, 3 Dose of intramuscular injection at Day 1, Month 2 and Month 6
447431|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447248|NCT00496483|B1|Baseline|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447249|NCT00496483|P1|Participant Flow|LCP-Tacro|"All Patients received Prograf for 7 days, then all patients were converted to once daily LCP-Tacro for 14 days. One dose adjustment up or down 25% was permitted on Day 15.~On Day 22 patients were converted back to their original twice daily dose of Prograf for a safety follow-up period of 30 days.~LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL."
447250|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447251|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447252|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447253|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447254|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447255|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447256|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447257|NCT00496483|O1|Outcome|Prograf|Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447258|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447259|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447260|NCT00496483|O1|Outcome|LCP-Tacro|LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.
447261|NCT00496483|E2|Reported Event|Prograf|"Prograf 0.5 mg, 1 mg and 5 mg capsules administered orally twice daily, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were entrolled into the study and one withdrew consent right after screening. Therefore 59 patients are inlcuded in the ITT safety set."
447262|NCT00496483|E1|Reported Event|LCP-Tacro|"LCP-Tacro 1 mg, 2 mg and 5 mg tablets administered orally QD, dosing per conversion algorithm to maintain tacrolimus trough concentrations between 7 to 12 ng/mL.~60 patients were enrolled into the study, but only 51 were dosed with LCP-Tacro."
447263|NCT00496470|B3|Baseline|Total|Total of all reporting groups
447264|NCT00496470|B2|Baseline|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447265|NCT00496470|B1|Baseline|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447266|NCT00496470|P2|Participant Flow|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447267|NCT00496470|P1|Participant Flow|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447268|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447269|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447270|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447271|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447272|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447273|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447274|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447275|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447276|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447277|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447278|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447279|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447280|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447281|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447282|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447470|NCT00495755|O1|Outcome|Response|
447285|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447286|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447287|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447288|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447289|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447290|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447291|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447292|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447293|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447294|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447295|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447296|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447297|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447298|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447299|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447300|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447301|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447302|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447303|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447304|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447305|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447306|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447307|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447308|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447309|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447310|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447311|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447312|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447313|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447314|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447315|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447316|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447317|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447318|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447319|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447320|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447321|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447322|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447323|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447324|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447325|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447326|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447327|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447328|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447329|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447330|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447331|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447332|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447333|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447334|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447335|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447336|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447337|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447338|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447339|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447340|NCT00496470|O2|Outcome|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447341|NCT00496470|O1|Outcome|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447342|NCT00496470|E2|Reported Event|Placebo+Tiotropium|Spiriva® (tiotropium) 18 mcg, one inhalation once daily and placebo Turbuhaler one inhalation once daily
447343|NCT00496470|E1|Reported Event|Symbicort+Tiotropium|Symbicort Turbuhaler® (budesonide/formoterol) 320/9 mcg, one inhalation twice daily and Spiriva® (tiotropium) 18 mcg, one inhalation once daily
447344|NCT00496379|B1|Baseline|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447345|NCT00496379|P1|Participant Flow|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447346|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447347|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447348|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447349|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447350|NCT00496379|O1|Outcome|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447351|NCT00496379|E1|Reported Event|Sagopilone|Either 16 mg/m2 or 22 mg/m2 IV Q3W
447352|NCT00496340|B1|Baseline|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447353|NCT00496340|P1|Participant Flow|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total area under curve (AUC) of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447354|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447385|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447355|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447356|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447357|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447358|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447359|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447360|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447361|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447362|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447363|NCT00496340|O1|Outcome|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447426|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447364|NCT00496340|E1|Reported Event|Conditioning Followed by HCT|"Pentostatin/Busulfan/Rituximab/Allogeneic Hematopoietic Cell Transplant (HCT)~Pre-conditioning therapy:~All participants receive pentostatin 4 mg/m^2 on day -28, may receive additional doses on days -21 & -14 depending on cell counts.~Conditioning:~Anti-seizure prophylaxis with lorazepam 0.5 mg every 6 hours beginning day -6~Intravenous Busulfan (1st dose) at a dose of 200mg/m^2 on day -4~Pentostatin, 4 mg/m^2 by intravenous infusion over 1-2 hours on days -4, -3~Intravenous Busulfan (2nd dose) on day (-2) to target a total AUC of 16,000 +/- 1600~Hematopoietic progenitor cells infused at least 36 hours after last dose of Busulfan~Patients with CD20+ expressing malignancies treated with rituximab at a dose of 375 mg/m^2 according to prescribing and institutional guidelines"
447365|NCT00496262|B1|Baseline|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447366|NCT00496262|P1|Participant Flow|Human Fibrinogen Concentrate|All enrolled subjects received a single IV infusion of 70 mg/kg body weight of human fibrinogen concentrate.
447367|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447368|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447369|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447370|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447371|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447372|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447373|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447374|NCT00496262|O1|Outcome|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447375|NCT00496262|O2|Outcome|1 Hour Post-infusion|1 hour after end of infusion
447376|NCT00496262|O1|Outcome|Pre-infusion|≤ 2 hours before start of infusion
447377|NCT00496262|E1|Reported Event|Human Fibrinogen Concentrate|Includes all subjects who received any portion of the infusion of human fibrinogen concentrate.
447378|NCT00496197|B1|Baseline|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447379|NCT00496197|P1|Participant Flow|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447380|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447381|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447382|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447383|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447384|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447427|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447428|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447471|NCT00495755|O1|Outcome|Maximum Tolerated Dose (MTD)|
447386|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447387|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447388|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447389|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447390|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447391|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447392|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447393|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447394|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447395|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447396|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447397|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447429|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447430|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447398|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447399|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447400|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447401|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447402|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447403|NCT00496197|O1|Outcome|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447404|NCT00496197|E1|Reported Event|Anidulafungin|Anidulafungin 200 milligrams (mg) intravenous (IV) loading dose followed by 100 mg IV infusion once a day (QD) for a minimum of 5 days and up to a maximum of 28 days. Participants who complete a minimum of 5 days IV treatment may be switched to oral (PO) fluconazole or voriconazole therapy any day between Day 6 and 28 dependent on criteria that includes negative blood cultures. Participants will continue on antifungal treatment for a minimum of 14 days after last positive blood and / or tissue culture and resolution of signs and symptoms of fungal infection.
447405|NCT00496080|B1|Baseline|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447406|NCT00496080|P1|Participant Flow|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447407|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447408|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447409|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447410|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
447411|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
447412|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
447413|NCT00496080|O1|Outcome|DUAO Device|Doppler-guided uterine artery occlusion device
447414|NCT00496080|E1|Reported Event|DUAO Device|Doppler-guided uterine artery occlusion device (Single-arm study)
447415|NCT00496054|B1|Baseline|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447416|NCT00496054|P1|Participant Flow|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447417|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447418|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447419|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447420|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447421|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447422|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447423|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447424|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447425|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447472|NCT00495755|E1|Reported Event|Campath (Alemtuzumab)|
447432|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447433|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447434|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447435|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447436|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447437|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447438|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447439|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447440|NCT00496054|O1|Outcome|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447441|NCT00496054|E1|Reported Event|RotaTeq™ Vaccine (V260)|Subjects enrolled in the study received three doses of RotaTeq™ orally at 3 separate visits 4 to 10 weeks apart.
447442|NCT00495820|B3|Baseline|Total|Total of all reporting groups
447443|NCT00495820|B2|Baseline|Arm 2|"Placebo~Placebo: Standard inactive pill."
447444|NCT00495820|B1|Baseline|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
447445|NCT00495820|P2|Participant Flow|Arm 2|"Placebo~Placebo: Standard inactive pill."
447446|NCT00495820|P1|Participant Flow|Arm 1|"Methylphenidate~Methylphenidate: Subject will receive 5mg BID for two weeks then 10mg BID until week 12 of the study."
447447|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
447448|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
447449|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
447450|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
447451|NCT00495820|O2|Outcome|Placebo Group|Subjects randomized to this group received placebo
447452|NCT00495820|O1|Outcome|Methylphenidate Group|Subjects randomized to this group received methylphenidate
447453|NCT00495820|E2|Reported Event|Placebo Group|Subjects randomized to this group received methylphenidate
447454|NCT00495820|E1|Reported Event|Methylphenidate Group|Subjects randomized to this group received methylphenidate
447455|NCT00495794|B3|Baseline|Total|Total of all reporting groups
447456|NCT00495794|B2|Baseline|Usual Care|Eligible patients receive usual care
447457|NCT00495794|B1|Baseline|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447458|NCT00495794|P2|Participant Flow|Usual Care|Eligible patients receive usual care
447459|NCT00495794|P1|Participant Flow|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447460|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
447461|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447462|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
447463|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447464|NCT00495794|O2|Outcome|Usual Care|Eligible patients receive usual care
447465|NCT00495794|O1|Outcome|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447466|NCT00495794|E2|Reported Event|Usual Care|Eligible patients receive usual care
447467|NCT00495794|E1|Reported Event|Pharmacist Management|"Eligible patients assigned to - adherence counseling and medication management delivered by a clinical pharmacist trained in behavioral counseling approaches (motivational interviewing)~Clinical pharmacist-based intervention: Pharmacist proactive outreach to patients systematically identified as having adherence or intensification problems; their use of tailored adherence counseling strategies; and their authorization to titrate medications according to prespecified algorithms"
447468|NCT00495755|B1|Baseline|Campath (Alemtuzumab)|
447469|NCT00495755|P1|Participant Flow|Campath (Alemtuzumab)|3 dose cohorts entered
447474|NCT00495677|B7|Baseline|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447475|NCT00495677|B6|Baseline|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447476|NCT00495677|B5|Baseline|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447477|NCT00495677|B4|Baseline|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447478|NCT00495677|B3|Baseline|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447479|NCT00495677|B2|Baseline|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447480|NCT00495677|B1|Baseline|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447481|NCT00495677|P7|Participant Flow|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447482|NCT00495677|P6|Participant Flow|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447483|NCT00495677|P5|Participant Flow|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447484|NCT00495677|P4|Participant Flow|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447485|NCT00495677|P3|Participant Flow|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447486|NCT00495677|P2|Participant Flow|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447487|NCT00495677|P1|Participant Flow|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447488|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447489|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447490|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447491|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447492|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447493|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447494|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447495|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447496|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447497|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447498|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447499|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447500|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447501|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447502|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447503|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447504|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447505|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447506|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447507|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447508|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447509|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447510|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447511|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447512|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447513|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
453839|NCT00477269|O2|Outcome|Placebo|Placebo
447514|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447515|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447516|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447517|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447518|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447519|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447520|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447521|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447522|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447523|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447524|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447525|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447526|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447527|NCT00495677|O7|Outcome|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447528|NCT00495677|O6|Outcome|PF-00232798 400 mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447529|NCT00495677|O5|Outcome|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447530|NCT00495677|O4|Outcome|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447531|NCT00495677|O3|Outcome|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447532|NCT00495677|O2|Outcome|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447533|NCT00495677|O1|Outcome|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447534|NCT00495677|E7|Reported Event|Placebo|Participants received placebo matched to PF-00232798 oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447535|NCT00495677|E6|Reported Event|PF-00232798 400mg|Participants received PF-00232798 400 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447536|NCT00495677|E5|Reported Event|PF-00232798 300 mg|Participants received PF-00232798 300 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447537|NCT00495677|E4|Reported Event|PF-00232798 150 mg|Participants received PF-00232798 150 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447538|NCT00495677|E3|Reported Event|PF-00232798 40 mg|Participants received PF-00232798 40 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 2.
447539|NCT00495677|E2|Reported Event|PF-00232798 20 mg|Participants received PF-00232798 20 mg oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447540|NCT00495677|E1|Reported Event|PF-00232798 5 mg|Participants received PF-00232798 5 milligram (mg) oral solution once daily up to Day 10 and were followed up to Day 25 in Stage 1.
447541|NCT00495625|B1|Baseline|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447542|NCT00495625|P1|Participant Flow|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447543|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447544|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447545|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447546|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447547|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447548|NCT00495625|O1|Outcome|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447549|NCT00495625|E1|Reported Event|Sunitinib Malate (SUO11248) Treatment|Once daily oral doses on days 1-28 of each 42-day cycle. The dose for the first 2 cycles was 37.5 mg daily for 28 days, every 42 days. Dose could be escalated to 50 mg daily for 28 days at the treating investigator's discretion.
447550|NCT00495612|B3|Baseline|Total|Total of all reporting groups
447551|NCT00495612|B2|Baseline|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447552|NCT00495612|B1|Baseline|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447553|NCT00495612|P2|Participant Flow|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447554|NCT00495612|P1|Participant Flow|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447555|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447556|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447557|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447558|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447559|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447560|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447561|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447562|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447563|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447564|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447565|NCT00495612|O2|Outcome|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447566|NCT00495612|O1|Outcome|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447567|NCT00495612|E2|Reported Event|Placebo|Patients received placebo as a subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. Patients received injections at the same time intervals as the omalizumab group.
447568|NCT00495612|E1|Reported Event|Omalizumab|Patients received omalizumab via subcutaneous injection either every 2 weeks or every 4 weeks for 16 weeks. The dose administered and the dosing interval were determined by serum total IgE level and body weight (measured before the start of treatment) per the study drug dosing table.
447569|NCT00495586|B3|Baseline|Total|Total of all reporting groups
447570|NCT00495586|B2|Baseline|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
447571|NCT00495586|B1|Baseline|Placebo|Placebo pills t.i.d. for 8 days
447572|NCT00495586|P2|Participant Flow|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
447573|NCT00495586|P1|Participant Flow|Placebo|Placebo pills t.i.d. for 8 days
447574|NCT00495586|O2|Outcome|Placebo|Ninety exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (90/123: 73.2%)
447575|NCT00495586|O1|Outcome|Amoxicillin and Clavulanic Acid|Eighty-three exacerbations were reported during the year of follow up among those patients who had clinical success at end of therapy visit (83/143: 58%)
447576|NCT00495586|O2|Outcome|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
447577|NCT00495586|O1|Outcome|Placebo|Placebo pills t.i.d. for 8 days
447578|NCT00495586|E2|Reported Event|Amoxycillin and Clavulanic Acid|Amoxycillin and clavulanate t.i.d. for 8 days
447579|NCT00495586|E1|Reported Event|Placebo|Placebo pills t.i.d. for 8 days
447580|NCT00495495|B1|Baseline|Ozone Treatment/Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
447680|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447581|NCT00495495|P1|Participant Flow|Ozone Treatment and Placebo Treatment|60-second Ozone device treatment compared to 60-second Placebo device treatment. Study utilized split-mouth design. The paired treatment assignment for the two teeth within each subject was performed according to a randomization table provided by the Biometrician. Randomization of teeth to Ozone treatment or Placebo treatment was stratifed according to tooth similarity.
447582|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
447583|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
447584|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
447585|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
447586|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
447587|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
447588|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
447589|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
447590|NCT00495495|O2|Outcome|Placebo Treatment|As part of the split-mouth design, subjects were randomized to receive placebo treatment on a randomly selected study tooth for 60 seconds.
447591|NCT00495495|O1|Outcome|Ozone Treatment|As part of the split-mouth design, subjects were randomized to receive Ozone treatment on a randomly selected study tooth for 60 seconds.
447592|NCT00495495|E1|Reported Event|Ozone Treatment and Placebo Treatment|Study utilized split-mouth design. Each participant had two teeth selected at the start of the study. Each participant was then randominzed to receive Ozone treatment on a randomly selected study tooth for 60 seconds and Placebo treatment on a randomly selected study tooth for 60 seconds.
447593|NCT00495391|B3|Baseline|Total|Total of all reporting groups
447594|NCT00495391|B2|Baseline|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447595|NCT00495391|B1|Baseline|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447596|NCT00495391|P2|Participant Flow|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447597|NCT00495391|P1|Participant Flow|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447598|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447599|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447600|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447601|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447602|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447603|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447604|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447605|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447606|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447607|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447608|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447609|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447610|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447611|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447612|NCT00495391|O2|Outcome|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447613|NCT00495391|O1|Outcome|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447614|NCT00495391|E2|Reported Event|Placebo+PR|"Oral placebo twice daily for 4 weeks followed by oral placebo twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks.~Placebo : One oral placebo tablet twice daily for 52 weeks."
447753|NCT00494585|P1|Participant Flow|CEP-701|80 mg orally twice daily for 30 days
447615|NCT00495391|E1|Reported Event|NTZ+PR|"Oral 500 mg nitazoxanide twice daily for 4 weeks followed by oral 500 mg nitazoxanide twice daily plus weekly injections of peginterferon alfa-2a plus oral ribavirin (1000 mg if <75 kg body weight or 1200 mg if ≥75 kg body weight) in daily divided doses for 48 weeks.~Ribavirin : 1000 mg (if <75 kg body weight) or 1200 mg (if ≥75 kg body weight) ribavirin in divided daily doses for 48 weeks.~Nitazoxanide : One oral 500 mg nitazoxanide tablet twice daily for 52 weeks.~Peginterferon alfa-2a : Weekly injections of 180µg peginterferon alfa-2a for 48 weeks."
447616|NCT00495222|B1|Baseline|Tissue Plication|
447617|NCT00495222|P1|Participant Flow|Tissue Plication|
447618|NCT00495222|O1|Outcome|Tissue Plication|
447619|NCT00495157|B4|Baseline|Total|Total of all reporting groups
447620|NCT00495157|B3|Baseline|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447621|NCT00495157|B2|Baseline|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447622|NCT00495157|B1|Baseline|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447623|NCT00495157|P3|Participant Flow|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447624|NCT00495157|P2|Participant Flow|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447625|NCT00495157|P1|Participant Flow|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447626|NCT00495157|O3|Outcome|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447627|NCT00495157|O2|Outcome|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447628|NCT00495157|O1|Outcome|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447629|NCT00495157|E3|Reported Event|Guideline-based Adjustment|Guideline-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447630|NCT00495157|E2|Reported Event|Biomarker-based Adjustment|Biomarker-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447631|NCT00495157|E1|Reported Event|Symptom-based Adjustment|Symptom-based adjustment of beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg or QVAR® 80 mcg)
447632|NCT00495131|B3|Baseline|Total|Total of all reporting groups
447633|NCT00495131|B2|Baseline|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447634|NCT00495131|B1|Baseline|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447635|NCT00495131|P2|Participant Flow|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447636|NCT00495131|P1|Participant Flow|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447637|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447638|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447639|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447640|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447641|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447642|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447643|NCT00495131|O2|Outcome|Peginterferon and Ribavirin (48 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 48 weeks
447644|NCT00495131|O1|Outcome|Peginterferon and Ribavirin (24 Weeks)|Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (<75 kg, 1000 mg/day; >= 75 kg, 1200 mg/day) for 24 weeks
447645|NCT00495079|B1|Baseline|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
447646|NCT00495079|P1|Participant Flow|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
447754|NCT00494585|O1|Outcome|CEP-701|80 mg orally twice daily for 30 days
447755|NCT00494585|E1|Reported Event|CEP-701|80 mg orally twice daily for 30 days
447647|NCT00495079|O1|Outcome|Marqibo|"Proportion if subjects who achieved CR+CRi as determined by the IRRC using the International Working Group (IWG)Criteria. The IRRC Evaluable analysis set(n=53) included subjects who received at least 1 dose of study drug and reviewable data.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+/-10 minutes) every 7 days (+/-3days)"
447648|NCT00495079|O1|Outcome|Marqibo|"The population analyzed included all subjects who received at least one dose of Marqibo. Subjects who did not die had their survival times censored on the date of last contact. The K-M method was used to estimate the distribution of overall survival.~Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes)every 7 days (+/- 3 days)"
447649|NCT00495079|O1|Outcome|Marqibo|"Duration of response derived using the IRRC determined response dates for subjects who achieved CR or CRi (n=8). The K-M product limit method was used to estimate the median event time.~Eligible subjects received Marqibo at 2.25mg^m2 intravenously via peripheral or central venous access over 60 minutes (+- 10 minutes)every 7 days (+/- 3 days)"
447650|NCT00495079|O1|Outcome|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
447651|NCT00495079|E1|Reported Event|Marqibo|Eligible subjects received study drug at 2.25 mg/m2 intravenously via peripheral or central venous access over 60 minutes (± 10 minutes).
447652|NCT00494975|B3|Baseline|Total|Total of all reporting groups
447653|NCT00494975|B2|Baseline|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
447654|NCT00494975|B1|Baseline|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
447655|NCT00494975|P2|Participant Flow|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
447656|NCT00494975|P1|Participant Flow|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
447657|NCT00494975|O2|Outcome|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
447658|NCT00494975|O1|Outcome|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
447659|NCT00494975|E2|Reported Event|Narrow Band Ultraviolet B Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
447660|NCT00494975|E1|Reported Event|Ultraviolet A Phototherapy|a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )
447661|NCT00494871|B3|Baseline|Total|Total of all reporting groups
447662|NCT00494871|B2|Baseline|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447663|NCT00494871|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447664|NCT00494871|P2|Participant Flow|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447665|NCT00494871|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447666|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447667|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447668|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447669|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447670|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447671|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447672|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447673|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447674|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447675|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447676|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447677|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447678|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447679|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447681|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447682|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447683|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447684|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447685|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447686|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447687|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447688|NCT00494871|O2|Outcome|Warfarin|Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
447689|NCT00494871|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period
447690|NCT00494871|E4|Reported Event|RG4: Warfarin FU Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
447691|NCT00494871|E3|Reported Event|RG3: Rivaroxaban Follow-up (FU) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected from last dose plus 2 days to end of trial
447692|NCT00494871|E2|Reported Event|RG2: Warfarin DB Period|Participants orally administered a warfarin potassium tablet and a rivaroxaban placebo tablet OD during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
447693|NCT00494871|E1|Reported Event|RG1: Rivaroxaban Double-blind (DB) Period|Participants orally administered a rivaroxaban 15 mg tablet (a 10 mg tablet for participants with creatinine clearance of 30 to 49 mL/min, inclusive, at screening) and a warfarin placebo tablet once daily (OD) during the double-blind treatment period. Safety data collected start with the first dose of study drug up to 2 days after the last dose
447694|NCT00494806|B3|Baseline|Total|Total of all reporting groups
447695|NCT00494806|B2|Baseline|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447696|NCT00494806|B1|Baseline|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447697|NCT00494806|P2|Participant Flow|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447698|NCT00494806|P1|Participant Flow|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447699|NCT00494806|O2|Outcome|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447700|NCT00494806|O1|Outcome|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447701|NCT00494806|E2|Reported Event|Standard Care|Standard care group got out of bed and sat in a non-rocking chair and ambulated beginning the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447702|NCT00494806|E1|Reported Event|Rocking Chair|Patients rocked in a rocking chair in 10-20 minute increments for at least one hour per day beginning on the first day after surgery. Activity was increased each day and continued until passage of first postoperative flatus.
447703|NCT00494780|B3|Baseline|Total|Total of all reporting groups
447704|NCT00494780|B2|Baseline|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447705|NCT00494780|B1|Baseline|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447706|NCT00494780|P2|Participant Flow|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447707|NCT00494780|P1|Participant Flow|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP (cyclophosphamide, doxorubicin, vincristine, prednisolone) on Day 3 of each 21-day cycle, with 300 milligrams (mg) in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447756|NCT00494507|B5|Baseline|Total|Total of all reporting groups
447784|NCT00494507|E3|Reported Event|HYP Open-Label Dichlorphenamide|Hyperkalemic participants received Dichlorphenamide for the 52 week open-label phase.
453840|NCT00477269|O1|Outcome|STI571|STI571
447708|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447709|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447710|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447711|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447712|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447713|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447714|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447715|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447716|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447717|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447718|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447719|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447720|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447721|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447722|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447723|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447724|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447725|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447726|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447727|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447728|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447729|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447730|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447731|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447732|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447733|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447734|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447735|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447736|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447737|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447738|NCT00494780|O2|Outcome|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447739|NCT00494780|O1|Outcome|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447740|NCT00494780|E4|Reported Event|1000 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447741|NCT00494780|E3|Reported Event|500 mg Ofatumumab + CHOP: Extended Follow-up|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447742|NCT00494780|E2|Reported Event|1000 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 1000 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447743|NCT00494780|E1|Reported Event|500 mg Ofatumumab + CHOP|Ofatumumab was given on Day 1 and CHOP on Day 3 of each 21-day cycle, with 300 mg in Cycle 1 and 500 mg in Cycles 2 to 6. Participants were followed up for 15 weeks during the Treatment period; then every 3 months for 24 months in the Follow-up period; then every 6 months until Month 60 or withdrawal from the study.
447744|NCT00494676|B1|Baseline|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447745|NCT00494676|P2|Participant Flow|Sham Prism Glasses Then Real|Sham prism glasses for 4 weeks followed by real prism glasses for 4 weeks
447746|NCT00494676|P1|Participant Flow|Real Prism Glasses Then Sham|Real prism glasses for 4 weeks followed by sham prism glasses for 4 weeks
447747|NCT00494676|O1|Outcome|Entire Study Population Who Discontinued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447748|NCT00494676|O1|Outcome|Entire Study Population Who Continued|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447749|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447750|NCT00494676|O1|Outcome|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447751|NCT00494676|E1|Reported Event|Entire Study Population|Includes groups allocated to receive real prism glasses first and sham prism glasses first
447752|NCT00494585|B1|Baseline|CEP-701|80 mg orally twice daily for 30 days
447757|NCT00494507|B4|Baseline|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447758|NCT00494507|B3|Baseline|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447759|NCT00494507|B2|Baseline|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447760|NCT00494507|B1|Baseline|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447761|NCT00494507|P4|Participant Flow|HOP Placebo|"Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447762|NCT00494507|P3|Participant Flow|HOP Dichlorphenamide|"Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447763|NCT00494507|P2|Participant Flow|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447764|NCT00494507|P1|Participant Flow|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447765|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447766|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447767|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447768|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447769|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447770|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447771|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447772|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447773|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants were randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447774|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447775|NCT00494507|O2|Outcome|HYP Placebo|"Hyperkalemic participants were randomized to Placebo for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447776|NCT00494507|O1|Outcome|HYP Dichlorphenamide|"Hyperkalemic participants were randomized to Dichlorphenamide for a 9 week double-blind phase. All participants then received Dichlorphenamide for a 52 week open-label phase.~Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day~Dichlorphenamide (open-label): 50mg tablet; maximum dosage 400mg/day"
447777|NCT00494507|O2|Outcome|HOP Placebo|Hypokalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447778|NCT00494507|O1|Outcome|HOP Dichlorphenamide|Hypokalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447779|NCT00494507|O2|Outcome|HYP Placebo|Hyperkalemic participants randomized to Placebo for a 9 week double-blind phase. Placebo (double-blind): Inactive substance manufactured to look like Dichlorphenamide 50mg tablet.
447780|NCT00494507|O1|Outcome|HYP Dichlorphenamide|Hyperkalemic participants randomized to Dichlorphenamide for a 9 week double-blind phase. Dichlorphenamide (double-blind): 50mg tablet; maximum dosage 400mg/day.
447781|NCT00494507|E6|Reported Event|HOP Open-Label Dichlorphenamide|Hypokalemic participants received Dichlorphenamide for the 52 week open-label phase.
447782|NCT00494507|E5|Reported Event|HOP Double-Blind Placebo|Hypokalemic participants were randomized to Placebo for the 9 week double-blind phase.
447783|NCT00494507|E4|Reported Event|HOP Double-Blind Dichlorphenamide|Hypokalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
447785|NCT00494507|E2|Reported Event|HYP Double-Blind Placebo|Hyperkalemic participants were randomized to Placebo for the 9 week double-blind phase.
447786|NCT00494507|E1|Reported Event|HYP Double-Blind Dichlorphenamide|Hyperkalemic participants were randomized to Dichlorphenamide for the 9 week double-blind phase.
447787|NCT00494494|B3|Baseline|Total|Total of all reporting groups
447788|NCT00494494|B2|Baseline|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447789|NCT00494494|B1|Baseline|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447790|NCT00494494|P2|Participant Flow|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447791|NCT00494494|P1|Participant Flow|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447792|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447793|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447794|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447795|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447796|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447797|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447798|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447799|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447800|NCT00494494|O2|Outcome|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447801|NCT00494494|O1|Outcome|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447802|NCT00494494|E2|Reported Event|Nepafenac|1 drop per study eye three times per day for 30 days plus standard care
447803|NCT00494494|E1|Reported Event|Standard Treatment|These subjects only received the standard of care for post-operative cataract, which consists of a topical antibiotic and a topical corticosteroid.
447804|NCT00494481|B3|Baseline|Total|Total of all reporting groups
447805|NCT00494481|B2|Baseline|Placebo Plus Docetaxel|placebo plus docetaxel
447806|NCT00494481|B1|Baseline|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
447807|NCT00494481|P2|Participant Flow|Placebo Plus Docetaxel|placebo plus docetaxel
447808|NCT00494481|P1|Participant Flow|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
447809|NCT00494481|O2|Outcome|Placebo Plus Docetaxel|placebo plus docetaxel
447810|NCT00494481|O1|Outcome|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
447811|NCT00494481|E2|Reported Event|Placebo Plus Docetaxel|placebo plus docetaxel
447812|NCT00494481|E1|Reported Event|Vandetanib Plus Docetaxel|vandetanib 100 mg plus docetaxel
447813|NCT00494442|B3|Baseline|Total|Total of all reporting groups
447814|NCT00494442|B2|Baseline|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447815|NCT00494442|B1|Baseline|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447816|NCT00494442|P2|Participant Flow|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447817|NCT00494442|P1|Participant Flow|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447818|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447819|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447820|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447821|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447822|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447823|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447824|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447825|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447826|NCT00494442|O2|Outcome|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447827|NCT00494442|O1|Outcome|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447828|NCT00494442|E2|Reported Event|Olaparib 400 mg bd|olaparib (KU-0059436; AZD2281) 400 mg oral capsules, twice daily
447829|NCT00494442|E1|Reported Event|Olaparib 100 mg bd|olaparib (KU-0059436; AZD2281) 100 mg oral capsules, twice daily
447830|NCT00494299|B3|Baseline|Total|Total of all reporting groups
447831|NCT00494299|B2|Baseline|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447832|NCT00494299|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447833|NCT00494299|P2|Participant Flow|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447834|NCT00494299|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447835|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447836|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447837|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447838|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447839|NCT00494299|O2|Outcome|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447840|NCT00494299|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447841|NCT00494299|E2|Reported Event|Placebo|Sorafenib (Nexavar, BAY43-9006) matching placebo (2 placebo tablets) orally administered bid (twice daily).
447842|NCT00494299|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib (Nexavar, BAY43-9006) administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) (morning and evening, every 12 hours as far as possible); Dose modification (delayed or reduced) was permitted due to toxicity.
447843|NCT00494234|B3|Baseline|Total|Total of all reporting groups
447844|NCT00494234|B2|Baseline|AZD2281 400 mg|
447845|NCT00494234|B1|Baseline|AZD2281 100 mg|
447846|NCT00494234|P2|Participant Flow|Olaparib 400 mg bd|Full Analysis Set
447847|NCT00494234|P1|Participant Flow|Olaparib 100 mg bd|Full Analysis Set
447848|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Patients who compled 6 cycles of treatment
447849|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Patients who compled 6 cycles of treatment
447850|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
447851|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
447852|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
447853|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
447854|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
447855|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
447856|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Number of responders
447857|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Number of responders
447858|NCT00494234|O2|Outcome|Olaparib 400 mg bd|Per Protocol Set
447859|NCT00494234|O1|Outcome|Olaparib 100 mg bd|Per Protocol Set
447860|NCT00494234|E2|Reported Event|AZD2281 400 mg|
447861|NCT00494234|E1|Reported Event|AZD2281 100 mg|
447862|NCT00494221|B4|Baseline|Total|Total of all reporting groups
447863|NCT00494221|B3|Baseline|Placebo|FOLFOX + Placebo
447864|NCT00494221|B2|Baseline|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447865|NCT00494221|B1|Baseline|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447866|NCT00494221|P3|Participant Flow|Placebo|FOLFOX + Placebo
447867|NCT00494221|P2|Participant Flow|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447868|NCT00494221|P1|Participant Flow|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447869|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
447870|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447871|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447872|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
447873|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447874|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447875|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
447876|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447877|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447878|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
447879|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447880|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447881|NCT00494221|O3|Outcome|Placebo|FOLFOX + Placebo
447882|NCT00494221|O2|Outcome|Cediranib 30 mg|FOLFOX + Cediranib 30 mg
447883|NCT00494221|O1|Outcome|Cediranib 20 mg|FOLFOX + Cediranib 20 mg
447884|NCT00494221|E3|Reported Event|Placebo|Placebo
447885|NCT00494221|E2|Reported Event|Cediranib 30 mg|Cediranib 30 mg
447886|NCT00494221|E1|Reported Event|Cediranib 20 mg|Cediranib 20 mg
447887|NCT00494143|B1|Baseline|CESR, Prescribed, Conventional|all subjects were randomized to each of the three interventions
447888|NCT00494143|P6|Participant Flow|CESR, Conventional, Prescribed|The individuals in this group were randomized to the prosthetic foot sequence, CESR foot, Conventional foot followed by Prescribed prosthetic foot.
447889|NCT00494143|P5|Participant Flow|CESR, Prescribed, Conventional|This arm included the individuals who were randomized to the prosthetic foot sequence, CESR foot followed by Prescribed foot, followed by Conventional foot.
447890|NCT00494143|P4|Participant Flow|Prescribed, Conventional, CESR|This arm included individuals who were randomized to the sequence, Prescribed prosthetic foot, conventional foot, CESR foot
447891|NCT00494143|P3|Participant Flow|Prescribed, CESR, Conventional|The randomized sequence of this arm was the Prescribed prosthetic foot, followed by the CESR foot followed by the Conventional prosthetic foot
447892|NCT00494143|P2|Participant Flow|Conventional, CESR, Prescribed|The randomized sequence of prosthetic use in this arm was Conventional foot, followed by CESR foot, followed by Prescribed.
447893|NCT00494143|P1|Participant Flow|Conventional, Prescribed, CESR|this is a randomized arm where the sequence of prosthetic use was their conventional foot, followed by prescribed foot, followed by the CESR foot
447894|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results while wearing the prescribed prosthetic foot
447895|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results while wearing the conventional prosthetic foot
447973|NCT00493974|P2|Participant Flow|Placebo|Matching placebo 4 times a day
447974|NCT00493974|P1|Participant Flow|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447896|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
447897|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|results with prescribed prosthetic foot
447898|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|results with the conventional prosthetic foot
447899|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
447900|NCT00494143|O3|Outcome|Prescribed Prosthetic Foot|subjects wearing the prescribed prosthetic foot
447901|NCT00494143|O2|Outcome|Conventional Prosthetic Foot|subjects wearing the conventional prosthetic foot
447902|NCT00494143|O1|Outcome|CESR Experimental Prosthetic Foot|"the CESR, controlled energy storage prosthetic foot~CESR Prosthetic Foot : a novel prosthetic foot that is designed to store energy and release it at a predetermined time in the gait cycle"
447903|NCT00494143|E3|Reported Event|Arm 2 Prescribed Prosthetic Foot|subjects randomized to the prescribed prosthetic foot
447904|NCT00494143|E2|Reported Event|Arm 1 Conventional Prosthetic Foot|subjects randomized to the conventional prosthetic foot
447905|NCT00494143|E1|Reported Event|Arm 3 CESR Prosthetic Foot|subjects randomized to the CESR prosthetic foot
447906|NCT00494091|B3|Baseline|Total|Total of all reporting groups
447907|NCT00494091|B2|Baseline|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447908|NCT00494091|B1|Baseline|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447909|NCT00494091|P2|Participant Flow|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447910|NCT00494091|P1|Participant Flow|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447911|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447912|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447913|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447914|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447915|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447916|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447917|NCT00494091|O2|Outcome|Temsirolimus 25 mg IV|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447918|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447919|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447920|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447921|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447922|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447923|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447924|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447925|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447926|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447927|NCT00494091|O2|Outcome|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447928|NCT00494091|O1|Outcome|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447929|NCT00494091|E2|Reported Event|Temsirolimus 25 mg|Temsirolimus 25 mg IV once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447930|NCT00494091|E1|Reported Event|Temsirolimus 20 mg/m^2|Temsirolimus 20 milligrams per square meter (mg/m^2) intravenously (IV) once weekly until disease progression, unacceptable toxicity, or withdrawal of consent.
447931|NCT00494026|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447932|NCT00494026|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447975|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447933|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447934|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447935|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447936|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447937|NCT00494026|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447938|NCT00494026|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 2 cycles then 500 mg/m2, IV, every 21 days x 2 cycles.~Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 2 cycles then AUC 5, IV, every 21 days x 2 cycles."
447939|NCT00494013|B3|Baseline|Total|Total of all reporting groups
447940|NCT00494013|B2|Baseline|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447941|NCT00494013|B1|Baseline|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447942|NCT00494013|P2|Participant Flow|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447943|NCT00494013|P1|Participant Flow|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447944|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447945|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447946|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447947|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447948|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447949|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447950|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447951|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447952|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447953|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447954|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447955|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447956|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447957|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447958|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447959|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447960|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447961|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447962|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447963|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447964|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447965|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447966|NCT00494013|O2|Outcome|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447967|NCT00494013|O1|Outcome|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447968|NCT00494013|E2|Reported Event|Detemir|Detemir: Patient specific dose administered subcutaneously once daily x 24 weeks.
447969|NCT00494013|E1|Reported Event|Insulin Lispro Protamine Suspension|Insulin Lispro Protamine Suspension: Patient specific dose administered subcutaneously once daily or twice daily x 24 weeks.
447970|NCT00493974|B3|Baseline|Total|Total of all reporting groups
447971|NCT00493974|B2|Baseline|Placebo|Matching placebo 4 times a day
447972|NCT00493974|B1|Baseline|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447978|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447979|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447980|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447981|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447982|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447983|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447984|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447985|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447986|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447987|NCT00493974|O2|Outcome|Placebo|Matching placebo 4 times a day
447988|NCT00493974|O1|Outcome|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447989|NCT00493974|E2|Reported Event|Placebo|Matching placebo 4 times a day
447990|NCT00493974|E1|Reported Event|Zileuton|Zileuton (Zyflo, 600 mg 4 times a day)
447991|NCT00493805|B1|Baseline|Total for Interventional Arm and Non Interventional Arm|
447992|NCT00493805|P2|Participant Flow|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
447993|NCT00493805|P1|Participant Flow|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
447994|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
447995|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
447996|NCT00493805|O2|Outcome|Interventional Arm HOMA IR > 2|Participants in the interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 12-16 weeks until their HCV polymerase chain reaction (PCR) results are available at Week 12. At Week 12, participants with >=2 log decrease of HCV RNA were randomized to continue either for another 36 weeks (Group A- a total of 48 weeks therapy) OR for another 60 weeks (Group B- a total of 72 weeks of therapy) with a 24-week follow up. Randomization was done between Day 1 Week 17 and Day 1 Week 25.
447997|NCT00493805|O1|Outcome|Non Interventional Arm HOMA IR <= 2|Participants in the non-interventional arm received PegIntron at a dose of 1.5 µg /kg based on the subject's body weight at baseline visit; administrated once weekly, subcutaneously (SC) for 48 weeks together with Rebetol at a dose of 800-1400 mg based on the subject's body weight at baseline visit; administered twice daily (BID), by mouth (PO) for 48 weeks (according to European labeling). Followed by a 24-week follow up period after end of treatment.
447998|NCT00493805|E2|Reported Event|Interventional Arm HOMA IR >2|
447999|NCT00493805|E1|Reported Event|Non Interventional Arm HOMA IR <=2|
448000|NCT00493779|B1|Baseline|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
448001|NCT00493779|P1|Participant Flow|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
448002|NCT00493779|O1|Outcome|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
448003|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
448004|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
448005|NCT00493779|O1|Outcome|Biomarker Analysis Population|All participants in the Clopidogrel Withdrawal Population having a baseline and at least one post clopidogrel withdrawal measurement for any of the 3 biomarkers collected.
448006|NCT00493779|E1|Reported Event|Clopidogrel Withdrawal Population|All enrolled participants in whom clopidogrel treatment was discontinued.
448007|NCT00493649|B1|Baseline|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
448035|NCT00493454|B1|Baseline|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
448080|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448008|NCT00493649|P1|Participant Flow|TC+H|This is a nonrandomized, noncomparative, open-label Phase II study. On Day 1 of each 21-day cycle for a total of 4 cycles, patients will receive docetaxel (Taxotere) 75 mg/m^2 IV plus cyclophosphamide (Cytoxan) 600 mg/m^2 IV, plus weekly trastuzumab (Herceptin) 4 mg/kg IV (loading dose, Day 1, Cycle 1 only) and 2 mg/kg IV (on Days 1, 8, and 15) thereafter. Subsequent cycles of therapy will continue until a total of 4 cycles of TC+H have been completed. Then, patients will continue to receive trastuzumab 6 mg/kg every 3 weeks to complete 1 year of anti-HER2 therapy as per the current standard of care.
448009|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
448010|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
448011|NCT00493649|O2|Outcome|cMYC-nonamplified Group|FISH ratio of cMYC gene copy number was less than 2.
448012|NCT00493649|O1|Outcome|cMYC-amplified Group|FISH ratio of cMYC gene copy number was 2 or greater.
448013|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
448014|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
448015|NCT00493649|O2|Outcome|TOP2A-nonamplified Group|FISH ratio of TOP2A gene copy number was less than 2.
448016|NCT00493649|O1|Outcome|TOP2A-amplified Group|FISH ratio of TOP2A gene copy number was 2 or greater.
448017|NCT00493649|E1|Reported Event|TC+H|docetaxel (Taxotere), plus cyclophosphamide (Cytoxan), plus weekly trastuzumab (Herceptin)
448018|NCT00493636|B3|Baseline|Total|Total of all reporting groups
448019|NCT00493636|B2|Baseline|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448020|NCT00493636|B1|Baseline|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448021|NCT00493636|P2|Participant Flow|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448022|NCT00493636|P1|Participant Flow|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448023|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448024|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448025|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448026|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448027|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448028|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448029|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448030|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448031|NCT00493636|O2|Outcome|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448032|NCT00493636|O1|Outcome|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448033|NCT00493636|E2|Reported Event|B (Placebo + Gemcitabine or Capecitabine)|"Placebo will be administered ( 2 tablets ) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Placebo: Placebo will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448034|NCT00493636|E1|Reported Event|A (Sorafenib + Gemcitabine or Capecitabine)|"Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours); Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle; Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)~Gemcitabine: Gemcitabine will be administered 1000 mg/m2 pm Days 1 and 8 of a 21 day cycle~Sorafenib: Sorafenib will be administered (400 mg; 2 tablets x 200 mg) orally twice daily (approximately every 12 hours)~Capecitabine: Capecitabine will be administered orally at a dose of 1,000 mg/m2 twice daily, within 30 minutes after a meal, for 14 days followed by a 7 day rest period (without capecitabine)."
448079|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448428|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448036|NCT00493454|P1|Participant Flow|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
448037|NCT00493454|O1|Outcome|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
448038|NCT00493454|E1|Reported Event|Ibritumomab Tiuxetan + Rituximab|Rituximab 250 mg/m² intravenous (IV) Days 1 and 8, 111In Ibritumomab Tiuxetan (5mCi of 111In, 1.6 mg of Ibritumomab Tiuxetan) IV (over 10 minutes) on Day 1; and 90Y Ibritumomab Tiuxetan 0.3 or 0.4 mCi/kg IV (over 10 minutes) on Day 8 after the Day 8 of Rituximab.
448039|NCT00493311|B3|Baseline|Total|Total of all reporting groups
448040|NCT00493311|B2|Baseline|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448041|NCT00493311|B1|Baseline|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448042|NCT00493311|P2|Participant Flow|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448043|NCT00493311|P1|Participant Flow|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448044|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448045|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448046|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448047|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448048|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448049|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448050|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448051|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448052|NCT00493311|O2|Outcome|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448053|NCT00493311|O1|Outcome|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448054|NCT00493311|E2|Reported Event|Intravenous (IV) Acetaminophen 1 g|After induction of fever by endotoxin administration, subjects received one infusion of 1 g of acetaminophen in 100 ml intravenous solution
448055|NCT00493311|E1|Reported Event|Intravenous (IV) Placebo|After induction of fever by endotoxin administration, subjects received one infusion of 100 ml intravenous placebo solution
448056|NCT00493285|B7|Baseline|TOTAL|Total of all reporting groups
448057|NCT00493285|B6|Baseline|10^6 PLACEBO|
448058|NCT00493285|B5|Baseline|10^6 MEDI-534|
448059|NCT00493285|B4|Baseline|10^5 PLACEBO|
448060|NCT00493285|B3|Baseline|10^5 MEDI-534|
448061|NCT00493285|B2|Baseline|10^4 PLACEBO|
448062|NCT00493285|B1|Baseline|10^4 MEDI-534|
448063|NCT00493285|P6|Participant Flow|10^6 PLACEBO|
448064|NCT00493285|P5|Participant Flow|10^6 MEDI-534|
448065|NCT00493285|P4|Participant Flow|10^5 PLACEBO|
448066|NCT00493285|P3|Participant Flow|10^5 MEDI-534|
448067|NCT00493285|P2|Participant Flow|10^4 PLACEBO|
448068|NCT00493285|P1|Participant Flow|10^4 MEDI-534|
448069|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448070|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448071|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448072|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448073|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448074|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448075|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448076|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448077|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448078|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448081|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448082|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448083|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448084|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448085|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448086|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448087|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448088|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448089|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448090|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448091|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448092|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448093|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448094|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448095|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448096|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448097|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448098|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448099|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448100|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448101|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448102|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448103|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448104|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448105|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448106|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448107|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448108|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448109|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448110|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448111|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448112|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448113|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448114|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448115|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448151|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448116|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448117|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448118|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448119|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448120|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448121|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448122|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448123|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448124|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448125|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448126|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448127|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448128|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448129|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448130|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448131|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448132|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448133|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448134|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448135|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448136|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448137|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448138|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448139|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448140|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448141|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448142|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448143|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448144|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448145|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448146|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448147|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448148|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448149|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448150|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
449090|NCT00490945|E4|Reported Event|50 mg VEC-162|Randomized to 50 mg VEC-162
448152|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448153|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448154|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448155|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448156|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448157|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448158|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448159|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448160|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448161|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448162|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448163|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448164|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448165|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448166|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448167|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448168|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448169|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448170|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448171|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448172|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448173|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448174|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448175|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448176|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448177|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448178|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448179|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448180|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448181|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448182|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448183|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448184|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448185|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448186|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
449091|NCT00490945|E3|Reported Event|20 mg VEC-162|Randomized to 20 mg VEC-162
448187|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448188|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448189|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448190|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448191|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448192|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448193|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448194|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448195|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448196|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448197|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448198|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448199|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448200|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448201|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448202|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448203|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448204|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448205|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448206|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448207|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448208|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448209|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448210|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448211|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448212|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448213|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448214|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448215|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448216|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448217|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448218|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448219|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448220|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448221|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448257|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448222|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448223|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448224|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448225|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448226|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448227|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448228|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448229|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448230|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448231|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448232|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448233|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448234|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448235|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448236|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448237|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448238|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448239|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448240|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448241|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448242|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448243|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448244|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448245|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448246|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448247|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448248|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448249|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448250|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448251|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448252|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448253|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448254|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448255|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448256|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
449092|NCT00490945|E2|Reported Event|10 mg VEC-162|Randomized to 10 mg VEC-162
448258|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448259|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448260|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448261|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448262|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448263|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448264|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448265|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448266|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448267|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448268|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448269|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448270|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448271|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448272|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448273|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448274|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448275|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448276|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448277|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448278|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448279|NCT00493285|O6|Outcome|10^6 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448280|NCT00493285|O5|Outcome|10^6 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448281|NCT00493285|O4|Outcome|10^5 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448282|NCT00493285|O3|Outcome|10^5 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448283|NCT00493285|O2|Outcome|10^4 Placebo|Placebo was supplied as a frozen preparation filled into syringes. Each 0.2 mL dose contained sucrose phosphate buffer.
448284|NCT00493285|O1|Outcome|10^4 MEDI-534|MEDI-534 vaccine was supplied as a frozen preparation of live, attenuated, b/h PIV3/RSV F2 virus filled into syringes. Each 0.2 mL dose contained MEDI-534 in a sucrose phosphate buffer.
448285|NCT00493285|E6|Reported Event|10^6 PLACEBO|
448286|NCT00493285|E5|Reported Event|10^6 MEDI-534|
448287|NCT00493285|E4|Reported Event|10^5 PLACEBO|
448288|NCT00493285|E3|Reported Event|10^5 MEDI-534|
448289|NCT00493285|E2|Reported Event|10^4 PLACEBO|
448290|NCT00493285|E1|Reported Event|10^4 MEDI-534|
448291|NCT00493246|B9|Baseline|Total|Total of all reporting groups
448292|NCT00493246|B8|Baseline|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448293|NCT00493246|B7|Baseline|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448294|NCT00493246|B6|Baseline|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448295|NCT00493246|B5|Baseline|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
449093|NCT00490945|E1|Reported Event|Placebo|Randomized to Placebo
448296|NCT00493246|B4|Baseline|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448297|NCT00493246|B3|Baseline|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448298|NCT00493246|B2|Baseline|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448299|NCT00493246|B1|Baseline|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448300|NCT00493246|P8|Participant Flow|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448301|NCT00493246|P7|Participant Flow|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448302|NCT00493246|P6|Participant Flow|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448303|NCT00493246|P5|Participant Flow|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448304|NCT00493246|P4|Participant Flow|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448305|NCT00493246|P3|Participant Flow|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448306|NCT00493246|P2|Participant Flow|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448307|NCT00493246|P1|Participant Flow|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448308|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448309|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448310|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448311|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448312|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448313|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448314|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448315|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448316|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448317|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448318|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448319|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448320|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448321|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448322|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
449094|NCT00490919|B3|Baseline|Total|Total of all reporting groups
448323|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448324|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448325|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448326|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448327|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448328|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448329|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448330|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448331|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448332|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448333|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448334|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448335|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448336|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448337|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448338|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448339|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448340|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448341|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448342|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448343|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448344|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448345|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448346|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448347|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448348|NCT00493246|O8|Outcome|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448349|NCT00493246|O7|Outcome|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448382|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
448350|NCT00493246|O6|Outcome|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448351|NCT00493246|O5|Outcome|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448352|NCT00493246|O4|Outcome|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448353|NCT00493246|O3|Outcome|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448354|NCT00493246|O2|Outcome|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448355|NCT00493246|O1|Outcome|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448356|NCT00493246|E8|Reported Event|Adolescents:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448357|NCT00493246|E7|Reported Event|Adolescents: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Adolescents aged 12 years to less than or equal to 16 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448358|NCT00493246|E6|Reported Event|Children: 15 mg/kg Every 6 Hours(q6h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448359|NCT00493246|E5|Reported Event|Children: 12.5 mg/kg Every 4 Hours (q4h) IV Acetaminophen|Children aged 2 years to less than 12 years received IV acetaminophen 12.5 mg/kg every 4 hours(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448360|NCT00493246|E4|Reported Event|Infants:15 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 15 mg/kg every 6 hours (maximum dose of 1 gram) Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448361|NCT00493246|E3|Reported Event|Infants: 12.5 mg/kg q4h IV Acetaminophen|Infants aged 29days to less than 24months received IV acetaminophen 12.5 mg/kg every 4 hours (q4h)(maximum of 660 mg/dose). Total maximum daily dose is 75 mg/kg or 4 grams, whichever is less.
448362|NCT00493246|E2|Reported Event|Neonates: 15 mg/kg Every 8 Hours (q8h) IV Acetaminophen|Full term neonates, 15 milligrams (mg)/kilogram (kg) Intravenous(IV) acetaminophen administered every 8 hours (q8h) (max daily dose of 50 mg/kg)
448363|NCT00493246|E1|Reported Event|Neonates:12.5 mg/kg Every 6 Hours (q6h) IV Acetaminophen|Full term neonates, 12.5 milligram(mg)per kilogram (kg) IV acetaminophen administered every 6 hours (q6h) (max daily dose of 50 mg/kg)
448364|NCT00493220|B7|Baseline|Total|Total of all reporting groups
448365|NCT00493220|B6|Baseline|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
448366|NCT00493220|B5|Baseline|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
448367|NCT00493220|B4|Baseline|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
448368|NCT00493220|B3|Baseline|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
448369|NCT00493220|B2|Baseline|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
448370|NCT00493220|B1|Baseline|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
448371|NCT00493220|P6|Participant Flow|IV, Placebo SC, HYLENEX SC|intravenous ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
448372|NCT00493220|P5|Participant Flow|IV, HYLENEX SC, Placebo SC|intravenous ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
448373|NCT00493220|P4|Participant Flow|Placebo SC, IV, HYLENEX SC|subcutaneous placebo and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous HYLENEX and ceftriaxone as third intervention
448374|NCT00493220|P3|Participant Flow|Placebo SC, HYLENEX SC, IV|subcutaneous placebo and ceftriaxone as first intervention, subcutaneous HYLENEX and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
448375|NCT00493220|P2|Participant Flow|HYLENEX SC, IV, Placebo SC|subcutaneous HYLENEX and ceftriaxone as first intervention, intravenous ceftriaxone as second intervention, subcutaneous placebo and ceftriaxone as third intervention
448376|NCT00493220|P1|Participant Flow|HYLENEX SC, Placebo SC, IV|subcutaneous HYLENEX and ceftriaxone as first intervention, subcutaneous placebo and ceftriaxone as second intervention, intravenous ceftriaxone as third intervention
448377|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
448378|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
448379|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
448380|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
448381|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
448383|NCT00493220|O3|Outcome|Intravenous|All per-protocol participant administered intravenous ceftriaxone
448384|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
448385|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous HYLENEX and ceftriaxone
448386|NCT00493220|O3|Outcome|Intravenous|All per-protocol participants administered intravenous ceftriaxone
448387|NCT00493220|O2|Outcome|Placebo SC|All per-protocol participants administered subcutaneous placebo and ceftriaxone
448388|NCT00493220|O1|Outcome|HYLENEX SC|All per-protocol participants administered subcutaneous hylenex and ceftriaxone
448389|NCT00493220|E3|Reported Event|Intravenous|All participants administered intravenous ceftriaxone
448390|NCT00493220|E2|Reported Event|Placebo SC|All participants administered subcutaneous placebo and ceftriaxone
448391|NCT00493220|E1|Reported Event|HYLENEX SC|All participants administered subcutaneous HYLENEX and ceftriaxone
448392|NCT00493181|B1|Baseline|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
448393|NCT00493181|P1|Participant Flow|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
448394|NCT00493181|O1|Outcome|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
448395|NCT00493181|E1|Reported Event|Interleukin-11|Starting dose 10 mcg/kg subcutaneously 3 times a week
448396|NCT00493038|B3|Baseline|Total|Total of all reporting groups
448397|NCT00493038|B2|Baseline|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448398|NCT00493038|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448399|NCT00493038|P2|Participant Flow|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448400|NCT00493038|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448401|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448402|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448403|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448404|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448405|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448406|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448407|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448408|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448409|NCT00493038|O2|Outcome|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448410|NCT00493038|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448411|NCT00493038|E2|Reported Event|Amoxicillin/Clavulanate|Amoxicillin/clavulanate 1000 mg matching tablets three times daily (TID) for 10 days and moxifloxacin 400 mg matching placebo tablets once daily (OD) for 7 days
448412|NCT00493038|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Moxifloxacin (Avelox, BAY12-8039) 400 mg tablets once daily (OD) for 7 days and amoxicillin/clavulanate 1000 mg matching placebo tablets three times daily (TID) for 10 days
448413|NCT00493012|B3|Baseline|Total|Total of all reporting groups
448414|NCT00493012|B2|Baseline|Placebo Comparator|A daily placebo oil is given for year
448415|NCT00493012|B1|Baseline|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448416|NCT00493012|P2|Participant Flow|Placebo Comparator|A daily placebo oil is given for year
448417|NCT00493012|P1|Participant Flow|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448418|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448419|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448420|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448421|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448422|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448423|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448424|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448425|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448426|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448427|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448429|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448430|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448431|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448432|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448433|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448434|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448435|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448436|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448437|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448438|NCT00493012|O2|Outcome|Placebo Comparator|A daily placebo oil is given for year
448439|NCT00493012|O1|Outcome|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448440|NCT00493012|E2|Reported Event|Placebo Comparator|A daily placebo oil is given for year
448441|NCT00493012|E1|Reported Event|Experiment|A daily vitamin D supplement of 3300 IU vitamin D is given as an oily solution for 1 year.
448442|NCT00492973|B3|Baseline|Total|Total of all reporting groups
448443|NCT00492973|B2|Baseline|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448444|NCT00492973|B1|Baseline|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448445|NCT00492973|P2|Participant Flow|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448446|NCT00492973|P1|Participant Flow|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448447|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448448|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448449|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448450|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448451|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448452|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448453|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448454|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448455|NCT00492973|O2|Outcome|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448456|NCT00492973|O1|Outcome|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448457|NCT00492973|E2|Reported Event|Corticosteroid|"Corticosteroid (methylprednisolone acetate)~methylprednisolone acetate : Same medications and doses as the active comparator, but with the addition of 40 mg of methylprednisolone acetate"
448458|NCT00492973|E1|Reported Event|Control Group|"Patients will receive intraoperative injections containing bupivacaine HCl, morphine, epinephrine, clonidine, cefuroxime, and normal saline, as per the surgeon's standard of care.~active comparator : bupivacaine HCl 80 mg, morphine 4 mg, epinephrine 300 micrograms, clonidine 100 micrograms, cefuroxime 750 mg, and normal saline"
448481|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448482|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448483|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
453841|NCT00477269|O2|Outcome|Placebo|Placebo
448459|NCT00492856|B1|Baseline|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses). If CRm, patients randomized to either (1) maintenance: ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle), or (2) observation. If CR or CRi, but not CRm, patients received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
448460|NCT00492856|P4|Participant Flow|Post-consolidation Gemtuzumab Ozogamicin|Patients who did not achieve CRm, but achieved CR/CRi and are PML-RARα-positive after consolidation received maintenance gemtuzumab ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does).
448461|NCT00492856|P3|Participant Flow|Post-consolidation Observation|Patients who achieved CRm after consolidation and were randomized to the observation arm.
448462|NCT00492856|P2|Participant Flow|Post-consolidation ATRA, 6-MP, MTX|Patients who achieved CRm after consolidation and were randomized or assigned to the treatment arm received ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle). Effective with Revision #6, all eligible patients were non-randomly assigned to receive maintenance with ATRA, 6-MP, and MTX.
448463|NCT00492856|P1|Participant Flow|Low and Intermediate Risk APL Patients|All patients received induction: ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6. If CR (CRm), CRi, or PR, patients received consolidation: Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
448464|NCT00492856|O2|Outcome|Post-consolidation Therapy Arm II|Patients receive no further chemotherapy. (Randomization and observation arm closed as of 05/27/10)
448465|NCT00492856|O1|Outcome|Post-consolidation Therapy Arm I|"Patients receive oral tretinoin twice daily on days 1-7, oral mercaptopurine once daily on days 1-14, and oral methotrexate on day 1. Treatment repeats every 2 weeks for up to 1 year.~mercaptopurine: Given orally~methotrexate: Given orally~tretinoin: Given orally"
448466|NCT00492856|O4|Outcome|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
448467|NCT00492856|O3|Outcome|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
448468|NCT00492856|O2|Outcome|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
448469|NCT00492856|O1|Outcome|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
448470|NCT00492856|E4|Reported Event|Gemtuzumab Ozogamicin|Gemtuzumab Ozogamicin 6 mg/m^2/day IV over 2 hours days 1 and 15 (up to 6 does)
448471|NCT00492856|E3|Reported Event|ATRA+6-MP+MTX|ATRA 45 mg/m^2/day orally divided BID 7 days repeated every other week, 6-MP 60 mg/m^2/day orally daily, Methotrexate 20 mg/m^2 orally once a week (1 year cycle).
448472|NCT00492856|E2|Reported Event|Consolidation|Arsenic trioxide 0.15 mg/kg/day IV infusion over 2 hours, 5 days per week for 5 weeks followed by 2 weeks of rest (2 courses). ATRA 45 mg/m^2/day orally divided BID days 1-7, Daunorubicin 50 mg/m^2/day IV bolus days 1-3 (2 courses).
448473|NCT00492856|E1|Reported Event|ATRA + Ara-C + Daunorubicin|ATRA 45 mg/m^2/day orally, divided BID, Ara-C 200 mg/m^2/day continuous IV infusion days 3-9, Daunorubicin 50 mg/m^2/day IV bolus days 3-6
448474|NCT00492752|B3|Baseline|Total|Total of all reporting groups
448475|NCT00492752|B2|Baseline|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448476|NCT00492752|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448477|NCT00492752|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Participants switched to Open-label Sorafenib treatment from Placebo after unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are the data reported in Reporting Group (RG) 3."
448478|NCT00492752|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Participants randomized to Sorafenib-matching Placebo until unblinding (August 19, 2007), Placebo tablets matching in appearance were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 2."
448479|NCT00492752|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|"Participants randomized to Sorafenib treatment from until unblinding (August 19, 2007) until end of trial (July 27, 2009), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
448480|NCT00492752|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|"Participants randomized to Sorafenib treatment until unblinding (August 19, 2007), Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.~Note: Safety Data of participants in the arm presented here are part of the data reported in Reporting Group (RG) 1."
448484|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448485|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448486|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448487|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448488|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448489|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448490|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448491|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448492|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448493|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448494|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448495|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448496|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448497|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448498|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448499|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448500|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448501|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448502|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448503|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448504|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448505|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448506|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448507|NCT00492752|O2|Outcome|Placebo|Placebo tablets matching in appearance were orally administered bid (twice daily).
448508|NCT00492752|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was administered orally at a dose of 400 mg (2 x 200 mg tablets) bid (twice daily); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily (od) and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448509|NCT00492752|E3|Reported Event|Placebo, Open Label Only (Participants Switched to Sorafenib)|Reporting Group 3 (RG 3): Participants switched to Open-label Sorafenib treatment from Placebo ( Data after unblinding [August 19, 2007] until end of this trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448548|NCT00492557|B3|Baseline|Total|Total of all reporting groups
448549|NCT00492557|B2|Baseline|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
448655|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448510|NCT00492752|E2|Reported Event|Placebo, All (Double-Blind and Open Label Phase)|Reporting Group 2 (RG 2): All participants randomized to Sorafenib-matching Placebo (data from start of treatment until end of trial [July 27, 2009]). Treatment for Double-Blind phase (before unblinding [August 19, 2007]): Placebo tablets matching in appearance were orally administered twice daily (bid); Treatment for Open Label phase (after unblinding [August 19, 2007]): Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448511|NCT00492752|E1|Reported Event|Sorafenib, All (Double-Blind and Open Label Phase)|Reporting Group 1 (RG 1): All participants randomized to Sorafenib treatment (data from start of treatment until end of trial [July 27, 2009]). Sorafenib administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg (2 x 200 mg tablets) once daily and 400 mg (2 x 200 mg tablets) every 2 days were permitted for treatment-emergent adverse events related to study treatment.
448512|NCT00492726|B3|Baseline|Total|Total of all reporting groups
448513|NCT00492726|B2|Baseline|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448514|NCT00492726|B1|Baseline|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448515|NCT00492726|P2|Participant Flow|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448516|NCT00492726|P1|Participant Flow|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448517|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448518|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448519|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448520|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448521|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448522|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448523|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448524|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448525|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448526|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448527|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448528|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448529|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448530|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448531|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448532|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448533|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448534|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448535|NCT00492726|O2|Outcome|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448536|NCT00492726|O1|Outcome|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448537|NCT00492726|E2|Reported Event|Ertapenem|Subject received Ertapenem 1.0 g in 50 mL for intravenous infusion and placebo matching Moxifloxacin (Moxifloxacin dummy) every 24 hours.
448538|NCT00492726|E1|Reported Event|Moxifloxacin (Avelox, BAY12-8039)|Subjects received placebo matching the comparator (Ertapenem dummy) and Moxifloxacin 400 mg in 250 mL for intravenous infusion every 24 hours.
448539|NCT00492583|B3|Baseline|Total|Total of all reporting groups
448540|NCT00492583|B2|Baseline|Bifidobacterium Lactis (BB-12)|
448541|NCT00492583|B1|Baseline|Placebo|
448542|NCT00492583|P2|Participant Flow|Bifidobacterium Lactis (BB-12)|
448543|NCT00492583|P1|Participant Flow|Placebo|
448544|NCT00492583|O2|Outcome|Bifidobacterium Lactis (BB-12)|
448545|NCT00492583|O1|Outcome|Placebo|
448546|NCT00492583|E2|Reported Event|Bifidobacterium Lactis (BB-12)|
448547|NCT00492583|E1|Reported Event|Placebo|
448550|NCT00492557|B1|Baseline|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
448551|NCT00492557|P2|Participant Flow|Placebo+TIV Followed by 13vPnC 1 Month Later|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM, followed by a single 0.5 mL 13vPnC, 1 month later.
448552|NCT00492557|P1|Participant Flow|13vPnC+TIV Followed by Placebo 1 Month Later|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM), followed by a single 0.5 mL 13vPnC placebo vaccine, 1 month later.
448553|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
448554|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
448555|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
448556|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
448557|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
448558|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
448559|NCT00492557|O2|Outcome|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM).
448560|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
448561|NCT00492557|O2|Outcome|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
448562|NCT00492557|O1|Outcome|13vPnC+TIV|Single 0.5 milliliter (mL) 13-valent pneumococcal conjugate vaccine (13vPnC) and a single 0.5 mL trivalent inactivated influenza vaccine (TIV), administered intramuscularly (IM).
448563|NCT00492557|E4|Reported Event|13vPnC|Single 0.5 mL 13vPnC (administered 1 month after single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, IM [Placebo + TIV]).
448564|NCT00492557|E3|Reported Event|Placebo+TIV|Single 0.5 mL 13vPnC placebo vaccine and a single 0.5 mL TIV, administered IM.
448565|NCT00492557|E2|Reported Event|Placebo|Single 0.5 mL 13vPnC placebo vaccine (administered 1 month after a single 0.5 mL 13vPnC and a single 0.5 mL TIV, IM [13vPnC + TIV]).
448566|NCT00492557|E1|Reported Event|13vPnC+TIV|Single 0.5 mL 13vPnC and a single 0.5 mL TIV, administered IM.
448567|NCT00492544|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448568|NCT00492544|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448569|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448570|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448571|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448572|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448573|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448574|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448575|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448576|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448577|NCT00492544|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448578|NCT00492544|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (HPV-16/18 L1 VLP AS04) according to a 0, 1, 6-month schedule.
448579|NCT00492531|B3|Baseline|Total|Total of all reporting groups
448580|NCT00492531|B2|Baseline|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448581|NCT00492531|B1|Baseline|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448582|NCT00492531|P2|Participant Flow|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448583|NCT00492531|P1|Participant Flow|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448584|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448585|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448586|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
449124|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
448587|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448588|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448589|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448590|NCT00492531|O2|Outcome|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448591|NCT00492531|O1|Outcome|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448592|NCT00492531|E2|Reported Event|Placebo|Subjects received matching oral dose of placebo 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448593|NCT00492531|E1|Reported Event|Sildenafil|Subjects received oral sildenafil 20 mg three times daily for six weeks, followed by 40 mg three times daily for four weeks, followed by 80 mg three times daily for six weeks (as tolerated).
448594|NCT00492401|B1|Baseline|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448595|NCT00492401|P1|Participant Flow|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448596|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448597|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448598|NCT00492401|O2|Outcome|Non Responder|Any patient that did not achieve a CR (Complete Response), or Incomplete CR was categorized as a non responder.
448599|NCT00492401|O1|Outcome|Responders|Any patient that achieved a CR (Complete Response), or Incomplete CR was categorized as a responder.
448600|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448601|NCT00492401|O1|Outcome|Decitabine|Decitabine 20mg/m2/day IV over 1 hour, days 1-10, repeat cycle every 28 days
448602|NCT00492401|E1|Reported Event|Treatment (Chemotherapy)|"Patients receive decitabine IV over 1 hour on days 1-10. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~decitabine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~high performance liquid chromatography: Correlative studies~microarray analysis: Correlative studies~RNA analysis: Correlative studies~mass spectrometry: Correlative studies~DNA methylation analysis: Correlative studies~matrix-assisted laser desorption/ionization time of flight mass spectrometry: Correlative studies"
448603|NCT00492336|B3|Baseline|Total|Total of all reporting groups
448604|NCT00492336|B2|Baseline|Inactive Pill|Treatment with Placebo
448605|NCT00492336|B1|Baseline|Rasagiline|Treatment with Rasagiline
448606|NCT00492336|P2|Participant Flow|Inactive Pill|Treatment with Placebo
448607|NCT00492336|P1|Participant Flow|Rasagiline|Treatment with Rasagiline
448608|NCT00492336|O2|Outcome|Inactive Pill|Treatment with Placebo
448609|NCT00492336|O1|Outcome|Rasagiline|Treatment with Rasagiline
448610|NCT00492336|E2|Reported Event|Inactive Pill|Treatment with Placebo
448611|NCT00492336|E1|Reported Event|Rasagiline|Treatment with Rasagiline
448612|NCT00492297|B1|Baseline|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448613|NCT00492297|P1|Participant Flow|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid), the treatment continued until subjects had clear palliative benefit and were tolerating treatment well, or until progressive disease (PD) or death (if earlier) recorded up to 97 weeks. Subjects withdrawn from Sorafenib but with optional standard treatment entered Active Follow-up (AFU) period, which was 30(+4) days for subjects who had PD at the end of treatment; or until PD was documented for subjects who had complete response (CR) or partial response (PR) or stable disease (SD) at the end of treatment up to 97 weeks . Once subject progressed went into survival only follow-up which continued until death occurred up to 172 weeks.
448614|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448615|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448616|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448617|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448618|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448619|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448620|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448621|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448622|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448623|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448624|NCT00492297|O1|Outcome|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448625|NCT00492297|E1|Reported Event|Sorafenib + Dacarbazine|Dacarbazine 1000 mg/m^2 on day one of repeated 21 day cycles, in combination with daily continuous oral Sorafenib (Nexavar, BAY43-9006), 400 mg twice a day (bid)
448626|NCT00492284|B5|Baseline|Total|Total of all reporting groups
448627|NCT00492284|B4|Baseline|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448628|NCT00492284|B3|Baseline|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448629|NCT00492284|B2|Baseline|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448630|NCT00492284|B1|Baseline|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448631|NCT00492284|P4|Participant Flow|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448632|NCT00492284|P3|Participant Flow|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448633|NCT00492284|P2|Participant Flow|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448634|NCT00492284|P1|Participant Flow|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448635|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448636|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448637|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448638|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448639|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448640|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448641|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448642|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448643|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448644|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448645|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448646|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448647|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448648|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448649|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448650|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448651|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448652|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448653|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448654|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448696|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448656|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448657|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448658|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448659|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448660|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448661|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448662|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448663|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448664|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448665|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448666|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448667|NCT00492284|O4|Outcome|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448668|NCT00492284|O3|Outcome|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448669|NCT00492284|O2|Outcome|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448670|NCT00492284|O1|Outcome|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448671|NCT00492284|E4|Reported Event|Ranibizumab|Lucentis monotherapy (0.5 mg)on Day 0, Month 1, and Month 2, and then as required monthly thereafter
448672|NCT00492284|E3|Reported Event|1/2 Fluence Double Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg) double therapy [within 2 hours]
448673|NCT00492284|E2|Reported Event|1/2 Fluence Triple Therapy|Reduced-fluence Visudyne (25 J/cm2: 300 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448674|NCT00492284|E1|Reported Event|1/4 Fluence Triple Therapy|Very low fluence Visudyne (15 J/cm2: 180 mW/cm2 for 83 seconds) followed by intravitreal Lucentis (0.5 mg)-Dexamethasone (0.5 mg) triple therapy [within 2 hours] on Day 0 and then as required every 2 months thereafter
448675|NCT00492232|B3|Baseline|Total|Total of all reporting groups
448676|NCT00492232|B2|Baseline|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448677|NCT00492232|B1|Baseline|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448678|NCT00492232|P2|Participant Flow|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448679|NCT00492232|P1|Participant Flow|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448680|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448681|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448682|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448683|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448684|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448685|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448686|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448687|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448688|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448689|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448690|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448691|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448692|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448693|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448694|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448695|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448697|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448698|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448699|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448700|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448701|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448702|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448703|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448704|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448705|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448706|NCT00492232|O2|Outcome|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448707|NCT00492232|O1|Outcome|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448708|NCT00492232|E2|Reported Event|Placebo QD|Ramelteon placebo-matching tablets, orally, once daily for up to 10 weeks in the DBTP.
448709|NCT00492232|E1|Reported Event|Ramelteon 8 mg QD|Ramelteon 8 mg, tablets, orally, once daily for up to 10 weeks in the DBTP.
448710|NCT00492206|B1|Baseline|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448711|NCT00492206|P1|Participant Flow|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448712|NCT00492206|O1|Outcome|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448713|NCT00492206|O1|Outcome|Received Concurrent Radiotherapy + Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448714|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448715|NCT00492206|O1|Outcome|Received ≥1 Dose of Cetuximab|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448716|NCT00492206|E1|Reported Event|Chest Radiotherapy + Cetuximab + Consolidation Therapy With ca|Participants (with surgically unresectable stage IIIA or IIIB NSCLC) received Cetuximab 400 mg/m2 IV (week 0 only), External beam radiation (weeks 1 - 7) and Cetuximab 250 mg/m2 IV weekly thereafter (weeks 1 - 7). Weeks 4-6 was the pre-consolidation phase during which participants received Carboplatin AUC = 6 IV, Paclitaxel 200 mg/m^2 IV Every 3 weeks x 3 Cycles. Cetuximab was given for up to a total of 26 weeks.
448717|NCT00492089|B3|Baseline|Total|Total of all reporting groups
448718|NCT00492089|B2|Baseline|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
448719|NCT00492089|B1|Baseline|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
448720|NCT00492089|P2|Participant Flow|Crossover Arm B: Placebo First, Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A.
448721|NCT00492089|P1|Participant Flow|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks.
448722|NCT00492089|O2|Outcome|Crossover Arm B: Placebo Then Bevacizumab|Placebo IV every 3 weeks for two courses, crossover at 6 weeks to receive Bevacizumab 7.5 mg/m^2 IV as in Arm A
448723|NCT00492089|O1|Outcome|Arm A: Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
448724|NCT00492089|E2|Reported Event|Placebo|First Intervention Placebo IV (only) every 3 weeks for two courses
448725|NCT00492089|E1|Reported Event|Bevacizumab|Bevacizumab 7.5 mg/m^2 intravenous (IV) every 3 weeks
448726|NCT00492063|B5|Baseline|Total|Total of all reporting groups
448727|NCT00492063|B4|Baseline|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448728|NCT00492063|B3|Baseline|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448729|NCT00492063|B2|Baseline|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448730|NCT00492063|B1|Baseline|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
449125|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
448731|NCT00492063|P4|Participant Flow|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448732|NCT00492063|P3|Participant Flow|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448733|NCT00492063|P2|Participant Flow|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448734|NCT00492063|P1|Participant Flow|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448735|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448736|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448737|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448738|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448739|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448740|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448741|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448742|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448743|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448744|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448745|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448746|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448747|NCT00492063|O4|Outcome|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448748|NCT00492063|O3|Outcome|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448749|NCT00492063|O2|Outcome|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448750|NCT00492063|O1|Outcome|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448751|NCT00492063|E4|Reported Event|TIV (Elderly)|Subjects ≥61 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448752|NCT00492063|E3|Reported Event|cTIV (Elderly)|Subjects ≥61 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448753|NCT00492063|E2|Reported Event|TIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of egg-derived influenza virus vaccine (TIV)
448754|NCT00492063|E1|Reported Event|cTIV (Adults)|Subjects ≥18 to ≤60 years of age who received one vaccination of cell culture-derived influenza virus vaccine (cTIV)
448755|NCT00492024|B3|Baseline|Total|Total of all reporting groups
448756|NCT00492024|B2|Baseline|Placebo|Matching placebo for 5 days
448757|NCT00492024|B1|Baseline|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448758|NCT00492024|P2|Participant Flow|Placebo|Matching placebo for 5 days
448759|NCT00492024|P1|Participant Flow|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448760|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448761|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448762|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448763|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448764|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448765|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448766|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448767|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448768|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448769|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448770|NCT00492024|O2|Outcome|Placebo|Matching placebo for 5 days
448771|NCT00492024|O1|Outcome|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448772|NCT00492024|E2|Reported Event|Placebo|Matching placebo for 5 days
448773|NCT00492024|E1|Reported Event|Moxifloxacin 400 mg|Moxifloxacin 400mg once daily for 5 days
448774|NCT00491894|B1|Baseline|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448775|NCT00491894|P1|Participant Flow|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448776|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448777|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448778|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448834|NCT00491738|B1|Baseline|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448779|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448780|NCT00491894|O1|Outcome|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448781|NCT00491894|E1|Reported Event|Patients With Chronic Drooling|A 4-week dose titration period until an optimal individualized response was obtained for each patient or a maximum dose of 0.1 mg/kg/dose was reached. Doses were not to exceed 3.0 mg/kg TID
448782|NCT00491829|B4|Baseline|Total|Total of all reporting groups
448783|NCT00491829|B3|Baseline|Placebo|"placebo qhs~placebo: placebo"
448784|NCT00491829|B2|Baseline|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
448785|NCT00491829|B1|Baseline|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
448786|NCT00491829|P3|Participant Flow|Placebo|"placebo qhs~placebo: placebo"
448787|NCT00491829|P2|Participant Flow|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
448788|NCT00491829|P1|Participant Flow|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
448789|NCT00491829|O3|Outcome|Placebo|"placebo qhs~placebo: placebo"
448790|NCT00491829|O2|Outcome|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
448791|NCT00491829|O1|Outcome|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
448792|NCT00491829|E3|Reported Event|Placebo|"placebo qhs~placebo: placebo"
448793|NCT00491829|E2|Reported Event|Flibanserin 100mg|"100 mg qhs~BIMT 17 BS 100 mg: flibanserin 100mg"
448794|NCT00491829|E1|Reported Event|Flibanserin 50mg|"50 mg qhs~BIMT 17 BS 50 mg: flibanserin 50 mg"
448795|NCT00491764|B7|Baseline|Total|Total of all reporting groups
448796|NCT00491764|B6|Baseline|Placebo for 24 Weeks|Placebo for 24 weeks.
448797|NCT00491764|B5|Baseline|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
448798|NCT00491764|B4|Baseline|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
448799|NCT00491764|B3|Baseline|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
448800|NCT00491764|B2|Baseline|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
448801|NCT00491764|B1|Baseline|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
448802|NCT00491764|P6|Participant Flow|Placebo for 24 Weeks|Placebo for 24 weeks.
448803|NCT00491764|P5|Participant Flow|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
448804|NCT00491764|P4|Participant Flow|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
448805|NCT00491764|P3|Participant Flow|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
448806|NCT00491764|P2|Participant Flow|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
448807|NCT00491764|P1|Participant Flow|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
448808|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
448809|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
448810|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
448811|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
448812|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
448813|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
448814|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
448815|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
448816|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
448817|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
448818|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
448819|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
448820|NCT00491764|O6|Outcome|Placebo for 24 Weeks|Placebo for 24 weeks.
448821|NCT00491764|O5|Outcome|Terbinafine 250 mg QD for 12 Weeks.|Terbinafine 250 mg QD for 12 weeks.
448822|NCT00491764|O4|Outcome|Posaconazole 400 mg QD for 12 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks.
448823|NCT00491764|O3|Outcome|Posaconazole 400 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks.
448824|NCT00491764|O2|Outcome|Posaconazole 200 mg QD for 24 Weeks.|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks.
448825|NCT00491764|O1|Outcome|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg daily (QD) for 24 weeks.
448826|NCT00491764|E6|Reported Event|Placebo for 24 Weeks|Placebo for 24 weeks
448827|NCT00491764|E5|Reported Event|Terbinafine 250 mg QD for 12 Weeks|Terbinafine 250 mg QD for 12 weeks
448828|NCT00491764|E4|Reported Event|Posaconazole 400 mg QD for 12 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 12 weeks
448829|NCT00491764|E3|Reported Event|Posaconazole 400 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 400 mg QD for 24 weeks
448830|NCT00491764|E2|Reported Event|Posaconazole 200 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 200 mg QD for 24 weeks
448831|NCT00491764|E1|Reported Event|Posaconazole 100 mg QD for 24 Weeks|Posaconazole oral suspension (40 mg/mL) 100 mg QD for 24 weeks
448832|NCT00491738|B3|Baseline|Total|Total of all reporting groups
448833|NCT00491738|B2|Baseline|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448835|NCT00491738|P2|Participant Flow|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448836|NCT00491738|P1|Participant Flow|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448837|NCT00491738|O2|Outcome|Placebo + Sunitinib|Intravenous infusion of placebo every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448838|NCT00491738|O1|Outcome|Bevacizumab + Sunitinib|Intravenous infusion of bevacizumab every 2 weeks at a dose of 10 mg/kg + sunitinib 50 mg/day for 4 weeks, followed by 2 weeks of rest
448839|NCT00491608|B1|Baseline|rThrombin|Participants who received at least 1 application of rThrombin during spinal or vascular surgery (arterial reconstruction or PAB,or AV vascular access procedure and had seronegative baseline rThrombin antibody status
448840|NCT00491608|P1|Participant Flow|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448841|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448842|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448843|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448844|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448845|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448846|NCT00491608|O1|Outcome|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448847|NCT00491608|E1|Reported Event|rThrombin, 1000 IU/mL|Participants received at least 1 application of recombinant thrombin (rThrombin), 1000 IU/mL, during a single surgical procedure. rThrombin was applied, per investigator judgment and standard clinical practice, directly or in combination with an absorbable gelatin sponge or powder.
448848|NCT00491556|B3|Baseline|Total|Total of all reporting groups
448849|NCT00491556|B2|Baseline|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
448850|NCT00491556|B1|Baseline|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448851|NCT00491556|P2|Participant Flow|Standard Care (STAND)|Began HAART with ATV/r under the current DHHS guidelines (CD4+ T cells below 350 cells/mm3 or for other clinical concerns as outlined in the recommendations and as determined by the site clinician).
448852|NCT00491556|P1|Participant Flow|Experimental-Early Initiation of HAART (EXP)|Began HAART consisting of TDF/FTC/ATV/r (preferred regimen), AZT/3TC/ATV/r, or other recommended NRTI HAART backbone with ATV/r upon entry to study. Subjects who achieved virologic control by week 24 (viral load (VL) < 100 copies/ml) and maintained good control through 48 weeks then entered deintensification (de-int) to ATV/r alone and were followed for two years.
448853|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448910|NCT00491530|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448854|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448855|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448856|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448857|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448858|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448859|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448860|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448861|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448862|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448984|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448863|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448864|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448865|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448866|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448867|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448868|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448869|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448870|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448871|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448986|NCT00491244|E2|Reported Event|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448872|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448873|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448874|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448875|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448876|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448877|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448878|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448879|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448880|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
449089|NCT00490945|E5|Reported Event|100 mg VEC-162|Randomized to 100 mg VEC-162
448881|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448882|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448883|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448884|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448885|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448886|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448887|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448888|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448906|NCT00491556|E1|Reported Event|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448889|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448890|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448891|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448892|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448893|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448894|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448895|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448896|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448907|NCT00491530|B4|Baseline|Total|Total of all reporting groups
448908|NCT00491530|B3|Baseline|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448909|NCT00491530|B2|Baseline|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448897|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448898|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448899|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448900|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448901|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448902|NCT00491556|O1|Outcome|Experimental Arm|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448903|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448904|NCT00491556|O1|Outcome|Experimental-Early Initiation of HAART (EXP)|"Subjects in the experimental group will begin HAART consisting of TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r upon entry or to begin treatment under current DHHS guidelines. Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years.~Early Initiation of Highly Active Anti-Retroviral Therapy: Treatment: TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r or other recommended NRTI backbone with ATV/r. Duration: Subjects in the experimental group who achieve virologic control by week 24 and maintain good control through 48 weeks will then de-intensify to ATV/r alone and will be followed for an additional two years."
448905|NCT00491556|E2|Reported Event|Standard Care Arm|"Subjects randomized to the standard care arm will begin HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care and will be followed for a total of three years. Under these guidelines and under current clinical standards, subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur.~Standard Care: Progression: Subjects on the standard care arm will begin therapy when the CD4+ T cell count drops below 350 cells/mm3 or other clinical criteria necessitating treatment as determined by the site clinician occur. Treatment: HAART with TDF/FTC/ATV/r (preferred), AZT/3TC/ATV/r, or other recommended ATV/r based HAART regimen according to current DHHS standard of care. Duration: three years."
448911|NCT00491530|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448912|NCT00491530|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448913|NCT00491530|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448914|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448915|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448916|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448917|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448918|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448919|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448920|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448921|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448922|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448923|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448924|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448925|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448926|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448927|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448928|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448929|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448930|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448931|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448932|NCT00491530|O3|Outcome|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448985|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448933|NCT00491530|O2|Outcome|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448934|NCT00491530|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448935|NCT00491530|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|Oral coadministration of ABT-335 (135 mg) + atorvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448936|NCT00491530|E2|Reported Event|ABT-335 + 40 mg Simvastatin|Oral coadministration of ABT-335 (135 mg) + simvastatin (40 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448937|NCT00491530|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|Oral coadministration of ABT-335 (135 mg) + rosuvastatin (20 mg), once daily, for up to 116 weeks (if beginning in the 12-week double-blind study) or up to 104 weeks (if beginning in the previous 52-week open-label year 1 study) and continuing in 52-week year 2 study
448938|NCT00491504|B5|Baseline|Total|Total of all reporting groups
448939|NCT00491504|B4|Baseline|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
448940|NCT00491504|B3|Baseline|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
448941|NCT00491504|B2|Baseline|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
448942|NCT00491504|B1|Baseline|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
448943|NCT00491504|P4|Participant Flow|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
448944|NCT00491504|P3|Participant Flow|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
448945|NCT00491504|P2|Participant Flow|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
448946|NCT00491504|P1|Participant Flow|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
448947|NCT00491504|O2|Outcome|Placebo|All subjects who received 2 sprays each nostril of placebo on Day 1
448948|NCT00491504|O1|Outcome|Mometasone Furoate Nasal Spray 200 mcg|All subjects who received 2 sprays each nostril (total 200 mcg) of Mometasone Furoate Nasal Spray (MFNS) on Day 1
448949|NCT00491504|E4|Reported Event|Placebo Day 8|Placebo: 2 sprays each nostril for 7 days
448950|NCT00491504|E3|Reported Event|Mometasone Furoate Nasal Spray Day 8|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (200 mcg daily) for 7 days
448951|NCT00491504|E2|Reported Event|Placebo Day 1|Placebo: 2 sprays each nostril for 1 dose
448952|NCT00491504|E1|Reported Event|Mometasone Furoate Nasal Spray Day 1|Mometasone Furoate Nasal Spray (MFNS): 2 sprays each nostril (total 200 mcg) for 1 dose
448953|NCT00491400|B3|Baseline|Total|Total of all reporting groups
448954|NCT00491400|B2|Baseline|Atorvastatin First|Atorvastatin First and Fenofibrate Second
448955|NCT00491400|B1|Baseline|Fenofibrate First|Fenofibrate First and Atorvastatin Second
448956|NCT00491400|P2|Participant Flow|Atorvastatin First|Participants randomized to receive atorvastatin first and fenofibrate second
448957|NCT00491400|P1|Participant Flow|Fenofibrate First|Participants randomized to receive fenofibrate first and atorvastatin second
448958|NCT00491400|O2|Outcome|Atorvastatin|Effect of atorvastatin treatment on lipid profile
448959|NCT00491400|O1|Outcome|Fenofibrate|Effect of fenofibrate treatment on lipid profile
448960|NCT00491400|O2|Outcome|Atorvastatin Treatment|Effect of atorvastatin on brachial artery FMD
448961|NCT00491400|O1|Outcome|Fenofibrate Treatment|Effect of fenofibrate on brachial artery FMD
448962|NCT00491400|E2|Reported Event|Atorvastatin First|Atorvastatin First and Fenofibrate Second
448963|NCT00491400|E1|Reported Event|Fenofibrate First|Fenofibrate First and Atorvastatin Second
448964|NCT00491387|B1|Baseline|Group 1|
448965|NCT00491387|P1|Participant Flow|Group 1|
448966|NCT00491387|O1|Outcome|Group 1|
448967|NCT00491387|E1|Reported Event|Group 1|
448968|NCT00491374|B3|Baseline|Total|Total of all reporting groups
448969|NCT00491374|B2|Baseline|Mometasone Furoate Nasal Spray|
448970|NCT00491374|B1|Baseline|Placebo|
448971|NCT00491374|P2|Participant Flow|Mometasone Furoate Nasal Spray|
448972|NCT00491374|P1|Participant Flow|Placebo|
448973|NCT00491374|O2|Outcome|Mometasone Furoate Nasal Spray|
448974|NCT00491374|O1|Outcome|Placebo|
448975|NCT00491374|E2|Reported Event|Mometasone Furoate Nasal Spray|
448976|NCT00491374|E1|Reported Event|Placebo|
448977|NCT00491244|B3|Baseline|Total|Total of all reporting groups
448978|NCT00491244|B2|Baseline|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448979|NCT00491244|B1|Baseline|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448980|NCT00491244|P2|Participant Flow|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448981|NCT00491244|P1|Participant Flow|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448982|NCT00491244|O2|Outcome|Peginterferon|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448983|NCT00491244|O1|Outcome|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448987|NCT00491244|E1|Reported Event|Peginterferon and Ribavirin|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 to 48 weeks (genotype 1: 48 weeks, genotype 2: 24 weeks)
448988|NCT00491179|B3|Baseline|Total|Total of all reporting groups
448989|NCT00491179|B2|Baseline|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
448990|NCT00491179|B1|Baseline|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
448991|NCT00491179|P2|Participant Flow|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
448992|NCT00491179|P1|Participant Flow|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
448993|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
448994|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
448995|NCT00491179|O2|Outcome|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
448996|NCT00491179|O1|Outcome|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
448997|NCT00491179|E2|Reported Event|Pegylated Interferon and Ribavirin for 24 Weeks (Genotype 2)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 24 weeks
448998|NCT00491179|E1|Reported Event|Pegylated Interferon and Ribavirin for 48 Weeks (Genotype 1)|Pegylated interferon alfa-2a (Pegasys, F. Hoffman-LaRoche) 135 ug/week plus ribavirin (Copegus, F. Hoffman-LaRoche) 200 mg/day for 48 weeks
448999|NCT00491075|B1|Baseline|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
449000|NCT00491075|P1|Participant Flow|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
449001|NCT00491075|O1|Outcome|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
449002|NCT00491075|E1|Reported Event|Pemetrexed + Gemcitabine|Pemetrexed 500 mg/m^2 intravenous (IV) and Gemcitabine 1500 mg/m^2 IV on Day 1.
449003|NCT00490971|B3|Baseline|Total|Total of all reporting groups
449004|NCT00490971|B2|Baseline|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449005|NCT00490971|B1|Baseline|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449006|NCT00490971|P5|Participant Flow|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449007|NCT00490971|P4|Participant Flow|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449008|NCT00490971|P3|Participant Flow|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449009|NCT00490971|P2|Participant Flow|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449010|NCT00490971|P1|Participant Flow|Paliperidone Extented Release (ER)|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449011|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449012|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449013|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449014|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449015|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449016|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449017|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449018|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449019|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449020|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449021|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449022|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449023|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449024|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449025|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449026|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
453842|NCT00477269|O1|Outcome|STI571|STI571
449027|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449028|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449029|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449030|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449031|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449032|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449033|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449034|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449035|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449036|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449037|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449038|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449039|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449040|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449041|NCT00490971|O5|Outcome|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449042|NCT00490971|O4|Outcome|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449043|NCT00490971|O3|Outcome|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449044|NCT00490971|O2|Outcome|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449045|NCT00490971|O1|Outcome|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449046|NCT00490971|E5|Reported Event|Olan/Olan|Maintenance period. Olanzapine Oral tablet, 5 mg/day to 20 mg/day, Once daily (Olanzapine in the acute and continuation period)
449047|NCT00490971|E4|Reported Event|Pali/Pali|Maintenance period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily (Paliperidone in the acute and continuation period)
449048|NCT00490971|E3|Reported Event|Pali/Placebo|Maintenance period. Placebo (Paliperidone in the acute and continuation period).
449049|NCT00490971|E2|Reported Event|Olanzapine|Acute and continuation period. Olanzapine: Oral tablet, 5 mg/day to 20 mg/day, Once daily.
449050|NCT00490971|E1|Reported Event|Paliperidone ER|Acute and continuation period. Paliperidone ER: Oral tablet, 3 mg/day to 12 mg/day, Once daily.
449051|NCT00490945|B6|Baseline|Total|Total of all reporting groups
449052|NCT00490945|B5|Baseline|100 mg VEC-162|Randomized to 100 mg VEC-162
449053|NCT00490945|B4|Baseline|50 mg VEC-162|Randomized to 50 mg VEC-162
449054|NCT00490945|B3|Baseline|20 mg VEC-162|Randomized to 20 mg VEC-162
449055|NCT00490945|B2|Baseline|10 mg VEC-162|Randomized to 10 mg VEC-162
449056|NCT00490945|B1|Baseline|Placebo|Randomized to Placebo
449057|NCT00490945|P5|Participant Flow|100 mg VEC-162|Randomized to 100 mg VEC-162
449058|NCT00490945|P4|Participant Flow|50 mg VEC-162|Randomized to 50 mg VEC-162
449059|NCT00490945|P3|Participant Flow|20 mg VEC-162|Randomized to 20 mg VEC-162
449060|NCT00490945|P2|Participant Flow|10 mg VEC-162|Randomized to 10 mg VEC-162
449061|NCT00490945|P1|Participant Flow|Placebo|Randomized to Placebo
449062|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449063|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449064|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449065|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
449066|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449067|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449068|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449069|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
449070|NCT00490945|O4|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449071|NCT00490945|O3|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449072|NCT00490945|O2|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449073|NCT00490945|O1|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
449074|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449075|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449076|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449077|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
449078|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
449079|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449080|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449081|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449082|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162**
449083|NCT00490945|O1|Outcome|Placebo*|Randomized to Placebo
449084|NCT00490945|O5|Outcome|100 mg VEC-162|Randomized to 100 mg VEC-162
449085|NCT00490945|O4|Outcome|50 mg VEC-162|Randomized to 50 mg VEC-162
449086|NCT00490945|O3|Outcome|20 mg VEC-162|Randomized to 20 mg VEC-162
449087|NCT00490945|O2|Outcome|10 mg VEC-162|Randomized to 10 mg VEC-162
449088|NCT00490945|O1|Outcome|Placebo|Randomized to Placebo
449095|NCT00490919|B2|Baseline|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449096|NCT00490919|B1|Baseline|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449097|NCT00490919|P3|Participant Flow|Double-blind Placebo TDS|Matching placebo transdermal patch (placebo TDS) 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
449098|NCT00490919|P2|Participant Flow|Double-blind BTDS 10 or 20|Buprenorphine transdermal patch (BTDS) 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase.
449099|NCT00490919|P1|Participant Flow|Open-label Run-in Period|"The open-label run-in period (< 27 days) (N = 1024 started) was designed to select subjects for randomization who met both tolerability and responsiveness criteria for either BTDS 10 or 20 (an enriched design).~Upon completion of the run-in period, 541 subjects were randomized and received treatment in the double-blind phase. Two subjects had no safety data after the randomization visit; therefore N = 539 for the randomized safety population."
449100|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449101|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449102|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449103|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449104|NCT00490919|O2|Outcome|Double-blind Placebo TDS|Matching placebo TDS 10 or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449105|NCT00490919|O1|Outcome|Double-blind BTDS|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
449106|NCT00490919|E3|Reported Event|Open-label Run-in Period, BTDS 5, 10, 20|Open-label BTDS 5, 10, 20 applied for 7-day wear
449107|NCT00490919|E2|Reported Event|Double-blind Placebo TDS 10, 20|Matching placebo TDS 10 or 20 applied for 7-day wear
449108|NCT00490919|E1|Reported Event|Double-blind BTDS 10, 20|Buprenorphine transdermal patch 10 mcg/h or 20 mcg/h applied for 7-day wear
449109|NCT00490841|B1|Baseline|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449110|NCT00490841|P1|Participant Flow|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449111|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449112|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449113|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449114|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449115|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449116|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449117|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449118|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449119|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449120|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449121|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449122|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449123|NCT00490841|O1|Outcome|RX Herculink Elite|Subjects recieving the RX Herculink Elite
449126|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449127|NCT00490841|O1|Outcome|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449128|NCT00490841|E1|Reported Event|RX Herculink Elite|To evaluate the safety and effectiveness of the RX Herculink Elite Renal Stent System in the treatment of suboptimal post-procedural percutaneous transluminal angioplasty (PTA) of atherosclerotic de novo or restenotic renal artery stenosis in patients with uncontrolled hypertension.
449129|NCT00490815|B3|Baseline|Total|Total of all reporting groups
449130|NCT00490815|B2|Baseline|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
449131|NCT00490815|B1|Baseline|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
449132|NCT00490815|P2|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant administered in one eye
449133|NCT00490815|P1|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant administered in one eye
449134|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
449135|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
449136|NCT00490815|O2|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
449137|NCT00490815|O1|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
449138|NCT00490815|E2|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur Implant
449139|NCT00490815|E1|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
449140|NCT00490802|B3|Baseline|Total|Total of all reporting groups
449141|NCT00490802|B2|Baseline|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449142|NCT00490802|B1|Baseline|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449143|NCT00490802|P2|Participant Flow|Placebo|Placebo Comparator : Placebo Comparator
449144|NCT00490802|P1|Participant Flow|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449145|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449146|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449147|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449148|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449149|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449150|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449151|NCT00490802|O2|Outcome|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449152|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449153|NCT00490802|O2|Outcome|Placebo|Placebo Comparator : Placebo Comparator
449154|NCT00490802|O1|Outcome|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449155|NCT00490802|E2|Reported Event|Placebo|"Drug~Placebo Comparator : Placebo Comparator"
449156|NCT00490802|E1|Reported Event|Intranasal Oxytocin|Oxytocin : Intranasal Oxytocin
449157|NCT00490724|B4|Baseline|Total|Total of all reporting groups
449158|NCT00490724|B3|Baseline|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449159|NCT00490724|B2|Baseline|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449160|NCT00490724|B1|Baseline|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449161|NCT00490724|P3|Participant Flow|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449162|NCT00490724|P2|Participant Flow|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449163|NCT00490724|P1|Participant Flow|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449164|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449243|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449165|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449166|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449167|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449168|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449169|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449170|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449171|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449172|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449173|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449174|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449175|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449176|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449177|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449178|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449179|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449180|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449181|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449182|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449183|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449184|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449185|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449186|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449187|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449188|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449189|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449190|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449191|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449192|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449193|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449194|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449195|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449196|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449197|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449198|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449199|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449200|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449201|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449202|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449203|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449204|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449205|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449206|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449207|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449208|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449209|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449210|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449211|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449212|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449213|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449214|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449215|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449216|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449217|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449218|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449219|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449220|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449221|NCT00490724|O3|Outcome|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449222|NCT00490724|O2|Outcome|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449223|NCT00490724|O1|Outcome|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449224|NCT00490724|E3|Reported Event|Nesiritide (2+0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 16.4 to 36.2 mcg/kg.
449225|NCT00490724|E2|Reported Event|Nesiritide (2+0.005)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 2 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (Fixed-dose) with dose of 0.005 mcg/kg/min and Period 2 (Flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 9.2 to 31.7 mcg/kg.
449226|NCT00490724|E1|Reported Event|Nesiritide (1+ 0.01)|Intravenous bolus treatment was administered over 1 minute (min) at a dose of 1 microgram per kilogram (mcg/kg) followed by 24 hour intravenous infusion which was comprised of Period 1 (fixed-dose) with dose of 0.01 mcg/kg/min and Period 2 (flexible-dose) where dosage were increased by 0.005 mcg/kg/min every 3 hours. Total dosage administered was 15.4 to 35.2 mcg/kg.
449227|NCT00490698|B1|Baseline|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
449228|NCT00490698|P1|Participant Flow|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
449229|NCT00490698|O1|Outcome|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
449230|NCT00490698|E1|Reported Event|Zoledronate + Atorvastatin|Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
449231|NCT00490646|B3|Baseline|Total|Total of all reporting groups
449232|NCT00490646|B2|Baseline|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449233|NCT00490646|B1|Baseline|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449234|NCT00490646|P2|Participant Flow|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449235|NCT00490646|P1|Participant Flow|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449236|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449237|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449238|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449239|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449240|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449241|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449242|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449288|NCT00490542|B2|Baseline|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449244|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449245|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449246|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449247|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449248|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449249|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449250|NCT00490646|O2|Outcome|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449251|NCT00490646|O1|Outcome|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449252|NCT00490646|E2|Reported Event|Trastuzumab 2 mg/kg + Ixabepilone 40 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + ixabepilone 40 mg/m^2 intravenous (IV) over 3 hours once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449253|NCT00490646|E1|Reported Event|Trastuzumab 2 mg/kg + Docetaxel 100 mg/m^2 IV|trastuzumab 4 mg/kg loading dose, then 2 mg/kg weekly + docetaxel 100 mg/m^2 IV over 1 hour once every 21 days (using a 21-day cycle); until disease progression or unacceptable toxicity.
449254|NCT00490555|B5|Baseline|Total|Total of all reporting groups
449255|NCT00490555|B4|Baseline|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449256|NCT00490555|B3|Baseline|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449257|NCT00490555|B2|Baseline|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449258|NCT00490555|B1|Baseline|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449259|NCT00490555|P4|Participant Flow|4) T Gel+DMPA|Testosterone 1% transdermal gel 10g, daily + placebo Dutasteride pill, daily + DMPA 300mg injection (IM)
449260|NCT00490555|P3|Participant Flow|3) T Gel+Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449261|NCT00490555|P2|Participant Flow|2) Testosterone (T) Gel|Testosterone 1% transdermal gel 10g (Testim)+ placebo pill, daily + placebo DMPA
449262|NCT00490555|P1|Participant Flow|1) Placebo|Placebo gel + Placebo pill + placebo DMPA
449263|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449264|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449265|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449266|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449267|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449268|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449269|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449270|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449271|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449272|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449273|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449274|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449275|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449276|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449277|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449278|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449279|NCT00490555|O4|Outcome|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449280|NCT00490555|O3|Outcome|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449281|NCT00490555|O2|Outcome|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449282|NCT00490555|O1|Outcome|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449283|NCT00490555|E4|Reported Event|4) T Gel+ DMPA|Testosterone 1% transdermal gel 10g + placebo Dutasteride + DMPA 300mg injection (IM)
449284|NCT00490555|E3|Reported Event|3) T Gel +Dutasteride|Testosterone 1% transdermal gel 10g + dutasteride 0.5mg Orally + placebo DMPA
449285|NCT00490555|E2|Reported Event|2) Testosterone Gel|Testosterone 1% transdermal gel 10g + placebo Dutasteride + placebo DMPA
449286|NCT00490555|E1|Reported Event|1) Placebo|Placebo Testosterone gel + Placebo Dutasteride pill + placebo DMPA
449287|NCT00490542|B3|Baseline|Total|Total of all reporting groups
449289|NCT00490542|B1|Baseline|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449290|NCT00490542|P2|Participant Flow|Double-blind Flexible-dose Ziprasidone Arm|Participants in this arm received a flexible dose of ziprasidone and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing for all subjects began at 20 mg twice a day and increased to between 80 and 160 mg/day total.
449291|NCT00490542|P1|Participant Flow|Double-blind Flexible-dose Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon). Dosing was flexible. Dosing for all subjects was determined based on clinician judgment in an identical manner to dosing in the ziprasidone arm.
449292|NCT00490542|O2|Outcome|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449293|NCT00490542|O1|Outcome|Ziprasidone Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449294|NCT00490542|E2|Reported Event|Geodon Arm|Participants in this arm received Geodon and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449295|NCT00490542|E1|Reported Event|Placebo Arm|Participants in this arm received placebo and were instructed to take it daily for 6 weeks. Participants did not know whether they were taking placebo or ziprasidone (Geodon).
449296|NCT00490477|B3|Baseline|Total|Total of all reporting groups
449297|NCT00490477|B2|Baseline|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
449298|NCT00490477|B1|Baseline|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
449299|NCT00490477|P2|Participant Flow|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
449300|NCT00490477|P1|Participant Flow|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
449301|NCT00490477|O2|Outcome|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
449302|NCT00490477|O1|Outcome|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
449303|NCT00490477|E2|Reported Event|Polymyxin-B Hemoperfusion Treatment (PMX-B)|patients with Gram-negative severe sepsis treated with standard therapy, according to the Surviving Sepsis Campaign, and an extracorporeal therapy with a PMX-B filter that could remove LPS
449304|NCT00490477|E1|Reported Event|Conventional Treatment (CONV)|patients with Gram-negative severe sepsis who received standard care according to Surviving Sepsis Campaign guidelines
449305|NCT00490269|B3|Baseline|Total|Total of all reporting groups
449306|NCT00490269|B2|Baseline|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449307|NCT00490269|B1|Baseline|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449308|NCT00490269|P2|Participant Flow|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449309|NCT00490269|P1|Participant Flow|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449310|NCT00490269|O2|Outcome|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449311|NCT00490269|O1|Outcome|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449312|NCT00490269|E2|Reported Event|Placebo|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449313|NCT00490269|E1|Reported Event|Dronabinol|Subjects received either 10mg of study drug or matched placebo capsules 5 times per day on non-smoking Days 4-8 at approximately 0800, 1100, 1400, 1700 and 2000 hours. On day 9, study drug (or placebo)was given only 3 times at the 1100 and 1400 hour time points. On day 10, only the first dose of study drug (or placebo) was given at 0800.
449314|NCT00490256|B3|Baseline|Total|Total of all reporting groups
449315|NCT00490256|B2|Baseline|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
449316|NCT00490256|B1|Baseline|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
449317|NCT00490256|P2|Participant Flow|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
449318|NCT00490256|P1|Participant Flow|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
449319|NCT00490256|O2|Outcome|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
449320|NCT00490256|O1|Outcome|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
449321|NCT00490256|E2|Reported Event|Experimental|This arm is the modified selective perfusion arm. This arm will receive the modified cardiopulmonary circuit.
449322|NCT00490256|E1|Reported Event|Control|Arm 1 is the control arm. This arm will receive the standard cardiopulmonary bypass circuit.
449323|NCT00490139|B5|Baseline|Total|Total of all reporting groups
449324|NCT00490139|B4|Baseline|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449325|NCT00490139|B3|Baseline|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449326|NCT00490139|B2|Baseline|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449327|NCT00490139|B1|Baseline|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449328|NCT00490139|P4|Participant Flow|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449329|NCT00490139|P3|Participant Flow|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449330|NCT00490139|P2|Participant Flow|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449383|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449384|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449385|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
453843|NCT00477269|O2|Outcome|Placebo|Placebo
449331|NCT00490139|P1|Participant Flow|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449332|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449333|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449334|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449335|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449336|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449337|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449338|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449386|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449387|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449388|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449389|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449339|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449340|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449341|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449342|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449343|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449344|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449345|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449346|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449390|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449391|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449392|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449393|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449347|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449348|NCT00490139|O4|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449349|NCT00490139|O3|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449350|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449351|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449352|NCT00490139|O4|Outcome|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449353|NCT00490139|O3|Outcome|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449354|NCT00490139|O2|Outcome|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449394|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449395|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449396|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449397|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449355|NCT00490139|O1|Outcome|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449356|NCT00490139|E4|Reported Event|Trastuzumab|Participants received treatment per one of the following three designs. Design 1: tras 8 mg/kg IV LD, followed by 6 mg/kg IV every 3 weeks for 52 weeks. Design 2: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received tras (6 mg/kg without a LD every 3 weeks for 40 weeks. Design 2B: weekly tras (4 mg/kg IV LD, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, participants received tras every 3 weeks (6 mg/kg without a LD) for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449357|NCT00490139|E3|Reported Event|Lapatinib|Participants received treatment per one of the following three designs. Design 1: oral lap 1500 mg daily for 52 weeks. Design 2: oral lap 750 mg daily concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks, for 12 weeks. After completion of paclitaxel or docetaxel, participants received oral lap at an increased dose of 1500 mg daily for 40 weeks. Design 2B: oral lap 750 mg daily concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV, for 18 weeks. After completion of docetaxel and carboplatin, oral lap was given at an increased dose of 1500 mg for 34 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449358|NCT00490139|E2|Reported Event|Trastuzumab Followed by Lapatinib|Participants received treatment per one of the following three designs. Design 1: weekly tras for 12 weeks (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly), followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV) concomitantly with weekly paclitaxel 80 mg/m^2 IV or docetaxel 75 mg/m^2 IV every 3 weeks for 12 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 34 weeks. Design 2B: weekly tras (4 mg/kg IV loading dose, followed by 2 mg/kg IV weekly) concomitantly with docetaxel 75 mg/m^2 every 3 weeks and carboplatin AUC6 IV for 18 weeks, followed by a 6-week washout period, followed by oral lap 1500 mg daily for 28 weeks. Participants also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449359|NCT00490139|E1|Reported Event|Lapatinib plusTrastuzumab|Participants (par.) received treatment per one of three designs. D1: oral lapatinib (OL) 1000 milligrams (mg) daily with trastuzumab (tras) (8 milligrams per kilogram [mg/kg] intravenous [IV] loading dose [LD], followed by 6 mg/kg IV every 3 weeks [E3W]) for 52 weeks (wks). D2: OL 750 mg daily plus wkly tras (4 mg/kg LD, followed by 2 mg/kg IV) concomitantly (conc.) with wkly paclitaxel (pac) 80 mg per squared meter (mg/m^2) IV or docetaxel (doc) 75 mg/m^2 IV E3W for 12 wks. After completion of pac or doc, par. received OL at an increased dose of 1000 mg daily in combination with tras (6 mg/kg without a LD) E3W for 40 wks. D2B: OL 750 mg plus wkly tras (4 mg/kg IV LD, followed by 2 mg/kg IV wkly) conc. with doc 75 mg/m^2 E3W and carboplatin (carb) AUC6 IV for 18 wks. After completion of doc and carb, par. received tras E3W (6 mg/kg without a LD) plus OL 1000 mg daily for 34 wks. Par. also received adjuvant radiotherapy and adjuvant anti-estrogen therapy when clinically indicated.
449360|NCT00490100|B1|Baseline|Treatment|
449361|NCT00490100|P1|Participant Flow|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
449362|NCT00490100|O1|Outcome|Treatment|Participants are young males with X-linked severe combined immunodeficiency complicated by growth failure. The participants will receive Insulin-like Growth Facor (Increlex) twice a day for up to 2 years.
449363|NCT00490100|O1|Outcome|Treatment|"XSCID patients with growth failre treated with Increlex, recombinant human IGF-1.~Increlex"
449364|NCT00490100|E1|Reported Event|Treatment|
449365|NCT00490035|B5|Baseline|Total Title|
449366|NCT00490035|B4|Baseline|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449367|NCT00490035|B3|Baseline|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449368|NCT00490035|B2|Baseline|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449369|NCT00490035|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
449370|NCT00490035|P4|Participant Flow|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449371|NCT00490035|P3|Participant Flow|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449372|NCT00490035|P2|Participant Flow|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449373|NCT00490035|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
449374|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449375|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449376|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449377|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449378|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449379|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449380|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449381|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449382|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449398|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449399|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449400|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449401|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449402|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449403|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449404|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449405|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449406|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449407|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449408|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449409|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449410|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449411|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449412|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449413|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449414|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449415|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449416|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449417|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449418|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449419|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449420|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449421|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449422|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449423|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449424|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449425|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449426|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449427|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449428|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449429|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449430|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449431|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449432|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449433|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449434|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449435|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449436|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449437|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449438|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449439|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449440|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449441|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449442|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449443|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449444|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449445|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449446|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449447|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449448|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449449|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449450|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449451|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449452|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449453|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449454|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449455|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449456|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449457|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
453844|NCT00477269|O1|Outcome|STI571|STI571
449458|NCT00490035|O4|Outcome|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449459|NCT00490035|O3|Outcome|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449460|NCT00490035|O2|Outcome|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449461|NCT00490035|O1|Outcome|Placebo|Matching Placebo tablets administered twice a day
449462|NCT00490035|E4|Reported Event|Brivaracetam 100 mg/Day|Brivaracetam 100 mg/day, 50 mg administered twice a day
449463|NCT00490035|E3|Reported Event|Brivaracetam 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
449464|NCT00490035|E2|Reported Event|Brivaracetam 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
449465|NCT00490035|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
449466|NCT00490022|B3|Baseline|Total|Total of all reporting groups
449467|NCT00490022|B2|Baseline|DHT Gel|DHT gel (70 mg/day) for one month
449468|NCT00490022|B1|Baseline|Placebo DHT Gel|Placebo gel for one month
449469|NCT00490022|P2|Participant Flow|DHT Gel|DHT gel (70 mg/day) for one month
449470|NCT00490022|P1|Participant Flow|Placebo DHT Gel|Placebo gel for one month
449471|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
449472|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
449473|NCT00490022|O2|Outcome|DHT Gel|DHT gel (70 mg/day) for one month
449474|NCT00490022|O1|Outcome|Placebo DHT Gel|Placebo gel for one month
449475|NCT00490022|E2|Reported Event|DHT Gel|DHT gel (70 mg/day) for one month
449476|NCT00490022|E1|Reported Event|Placebo DHT Gel|Placebo gel for one month
449477|NCT00489970|B3|Baseline|Total|Total of all reporting groups
449478|NCT00489970|B2|Baseline|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449479|NCT00489970|B1|Baseline|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449480|NCT00489970|P2|Participant Flow|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449481|NCT00489970|P1|Participant Flow|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449482|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449483|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449484|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449485|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449486|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449487|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449488|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449489|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449490|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449491|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449492|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449493|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449494|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449495|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449496|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449497|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449498|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449499|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449500|NCT00489970|O2|Outcome|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449501|NCT00489970|O1|Outcome|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449502|NCT00489970|E2|Reported Event|Adacel Group|Subjects received in the primary study (NCT00346073) a single dose of Adacel vaccine intramuscularly in the deltoid region of the non-dominant upper arm.
449503|NCT00489970|E1|Reported Event|Boostrix Group|Subjects received in the primary study (NCT00346073) a single dose of Boostrix vaccine [Tdap](GSK776423) intramuscularly in the deltoid region of the non-dominant upper arm.
449504|NCT00489866|B3|Baseline|Total|Total of all reporting groups
449505|NCT00489866|B2|Baseline|Placebo|Identical to Aripiprazole
449506|NCT00489866|B1|Baseline|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
449507|NCT00489866|P2|Participant Flow|Placebo|Identical to Aripiprazole
449508|NCT00489866|P1|Participant Flow|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
449509|NCT00489866|O2|Outcome|Depression Symptoms Placebo Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
449510|NCT00489866|O1|Outcome|Depression Symptoms Aripiprazole Treated Group|The Beck Depression Inventory-II (BDI) is a very sensitive and widely used instrument used to detect depressive symptoms. It consists of 21 items that assess the intensity of depression in both clinical and non-clinical subjects. Each item is a list of four statements arranged in increasing severity regarding a particular symptom of depression.
449511|NCT00489866|O2|Outcome|Resilience Symptoms PlaceboTreated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
449512|NCT00489866|O1|Outcome|Resilience Symptoms Aripiprazole Treated Group|This scale measures resilience. Range of scores (0-100). A score of 0 is suggestive of no resilience, a score of 100 is suggestive of high level of resilience.
449513|NCT00489866|O2|Outcome|Psychotic Symptoms Placebo Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
449514|NCT00489866|O1|Outcome|Psychotic Symptoms Aripiprazole Treated Group|The PANSS is a widely used measure with several subdomains, including positive symptoms, negative symptoms, and general psychopathology of schizophrenia. Lower scores are indicative of fewer symptoms; higher scores are indicative of more symptoms. Total PANSS scores range from 0-20.
449515|NCT00489866|O2|Outcome|Cognitive Symptoms PlaceboTreated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
449516|NCT00489866|O1|Outcome|Cognitive Symptoms Aripiprazole Treated Group|The BACS includes brief assessments of executive functions, verbal fluency, attention, verbal memory, working memory and motor speed. Z-scores are calculated from composite scores. Higher z-scores are indicative of better cognitive performance, lower z-scores are indicative of lower cognitive performance. Range of z-scores anticipated to be between -3 and 3.
449517|NCT00489866|O2|Outcome|PTSD Symptoms Placebo Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
449518|NCT00489866|O1|Outcome|PTSD Symptoms Aripiprazole Treated Group|The Clinician Administered PTSD Scale (CAPS) was used to measure changes in PTSD symptoms across the duration of the study.Mean change scores in posttraumatic stress disorder symptoms. Scores may range from 0 (no symptoms) to 136 (severe symptoms; score of 136 is based on the first 17 CAPS items administered). A reduced CAPS score indicates a reduction in (improvement) PTSD symptoms, while an increase in CAPS score indicates an increase (worsening) in PTSD symptoms.
449519|NCT00489866|E2|Reported Event|Placebo|Identical to Aripiprazole
449520|NCT00489866|E1|Reported Event|Aripiprazole|Aripiprazole: 5 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-10 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-15 mg taken once a day orally for 2 weeks, then Aripiprazole: 5-20 mg taken once a day orally for 2 weeks
449521|NCT00489853|B1|Baseline|Entire Study Population|Cross over study with 3 Arms. (1)Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily. (2)Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily. (3) Placebo, 1 inhalation twice daily
449522|NCT00489853|P3|Participant Flow|Placebo Then Formoterol Then Symbicort|Placebo, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449523|NCT00489853|P2|Participant Flow|Formoterol Then Symbicort Then Placebo|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
449524|NCT00489853|P1|Participant Flow|Symbicort Then Formoterol Then Placebo|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily, then Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily, then Placebo, 1 inhalation twice daily
449525|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449526|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449527|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449528|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449529|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449828|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449530|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449531|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449532|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449533|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449534|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449535|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449536|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449537|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449538|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449539|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449540|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449541|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449542|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449543|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449544|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449545|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449546|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449547|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449548|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449549|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449550|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449551|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449552|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449553|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449554|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449555|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449556|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449557|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449558|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449559|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449560|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449561|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449562|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449563|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449564|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449565|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449566|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449567|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449568|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449569|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449570|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449571|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449572|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449573|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449574|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449575|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449576|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449577|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449578|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449579|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449580|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449581|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449582|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449583|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449584|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449585|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449586|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449587|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449588|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449589|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449590|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449591|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449592|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449593|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449594|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449595|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449596|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449597|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449598|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449599|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449600|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449601|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449602|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449603|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449604|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449605|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449606|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449607|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449608|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449609|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449610|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449611|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449612|NCT00489853|O3|Outcome|Placebo|Placebo, 1 inhalation twice daily
449613|NCT00489853|O2|Outcome|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449614|NCT00489853|O1|Outcome|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449615|NCT00489853|E3|Reported Event|Placebo|Placebo, 1 inhalation twice daily
449616|NCT00489853|E2|Reported Event|Formoterol|Formoterol Turbuhaler 9 micrograms, 1 inhalation twice daily
449617|NCT00489853|E1|Reported Event|Symbicort|Symbicort (budesonide/formoterol) Turbuhaler 320/9 micrograms, 1 inhalation twice daily
449618|NCT00489736|B3|Baseline|Total|Total of all reporting groups
449619|NCT00489736|B2|Baseline|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449620|NCT00489736|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449621|NCT00489736|P2|Participant Flow|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449622|NCT00489736|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449623|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449624|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449625|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449626|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449627|NCT00489736|O2|Outcome|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449628|NCT00489736|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449629|NCT00489736|E2|Reported Event|Amiodarone 600mg/200mg od|amiodarone 600mg once daily (od) for 28 days, then amiodarone 200mg once daily (od)
449630|NCT00489736|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily (bid)
449631|NCT00489554|B1|Baseline|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449632|NCT00489554|P1|Participant Flow|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449633|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449634|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449635|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449636|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449637|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449638|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449639|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449640|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449683|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449641|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449642|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449643|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449644|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449645|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449646|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449647|NCT00489554|O1|Outcome|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449648|NCT00489554|E1|Reported Event|Synflorix Vaccine Group|Subjects receiving Synflorix vaccine co-administered with DTPa-HBV-IPV/Hib (Infanrix hexa) vaccine at 2-4-6 months of age, and co-administered with HRV (Rotarix) vaccine at 2-4 months of age.
449649|NCT00489541|B3|Baseline|Total|Total of all reporting groups
449650|NCT00489541|B2|Baseline|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
449651|NCT00489541|B1|Baseline|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
449652|NCT00489541|P2|Participant Flow|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
449653|NCT00489541|P1|Participant Flow|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
449654|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
449655|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
449656|NCT00489541|O2|Outcome|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
449657|NCT00489541|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
449658|NCT00489541|E2|Reported Event|Historical Control Bare Metal Stent (BMS)|The control group consists of 125 matched bare metal Express subjects from the TAXUS V trial (NCT00301522).
449659|NCT00489541|E1|Reported Event|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
449660|NCT00489489|B4|Baseline|Total|Total of all reporting groups
449661|NCT00489489|B3|Baseline|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449662|NCT00489489|B2|Baseline|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449663|NCT00489489|B1|Baseline|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449664|NCT00489489|P3|Participant Flow|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449665|NCT00489489|P2|Participant Flow|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449666|NCT00489489|P1|Participant Flow|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449667|NCT00489489|O2|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
449668|NCT00489489|O1|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
449669|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449670|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449671|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449672|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449673|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449674|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449675|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449676|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449677|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449678|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449679|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449680|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449681|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449682|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449684|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449685|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449686|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449687|NCT00489489|O3|Outcome|Teriflunomide 14 mg + IFN-β|Teriflunomide 14 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449688|NCT00489489|O2|Outcome|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449689|NCT00489489|O1|Outcome|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with interferon-β (IFN-β) for 24 weeks
449690|NCT00489489|E3|Reported Event|Teriflunomide 14 mg + + IFN-β|Teriflunomide 14 mg once daily concomitantly with IFN-β for 24 weeks
449691|NCT00489489|E2|Reported Event|Teriflunomide 7 mg + IFN-β|Teriflunomide 7 mg once daily concomitantly with IFN-β for 24 weeks
449692|NCT00489489|E1|Reported Event|Placebo + IFN-β|Placebo (for teriflunomide) once daily concomitantly with IFN-β for 24 weeks
449693|NCT00489424|B4|Baseline|Total|Total of all reporting groups
449694|NCT00489424|B3|Baseline|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449695|NCT00489424|B2|Baseline|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449696|NCT00489424|B1|Baseline|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449697|NCT00489424|P3|Participant Flow|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449698|NCT00489424|P2|Participant Flow|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449699|NCT00489424|P1|Participant Flow|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449700|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449701|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449702|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449703|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449704|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449705|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449706|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449707|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449808|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449809|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449810|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449708|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449709|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449710|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449711|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449712|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449713|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449714|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449715|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449716|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449717|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449718|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449719|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449720|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449721|NCT00489424|O3|Outcome|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449722|NCT00489424|O2|Outcome|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449723|NCT00489424|O1|Outcome|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449724|NCT00489424|E3|Reported Event|Fluvastatin|2 capsules of fluvastatin 40 mg and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449725|NCT00489424|E2|Reported Event|Acetaminophen|2 capsules of acetaminophen 325 mg and 2 capsules of placebo (matching fluvastatin) administered 45 +/- 15 minutes prior to i.v. infusion of zoledronic acid 5 mg, then 2 capsules of acetaminophen 325 mg 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449811|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449726|NCT00489424|E1|Reported Event|Placebo|2 capsules of placebo (matching fluvastatin) and 2 capsules of placebo (matching acetaminophen) administered 45 +/- 15 minutes prior to intravenous (i.v.) infusion of zoledronic acid 5 mg, then 2 capsules of placebo (matching acetaminophen) 4 times per day (including medication taken at study site at visit 2/day 1) over the next 3 days (not exceeding 8 capsules in a 24-hour period).
449727|NCT00489359|B3|Baseline|Total|Total of all reporting groups
449728|NCT00489359|B2|Baseline|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449729|NCT00489359|B1|Baseline|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
449730|NCT00489359|P2|Participant Flow|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449731|NCT00489359|P1|Participant Flow|Pemetrexed/Carboplatin Phase 1|Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin [area under the concentration-time curve (AUC) 5 or 6 mg/mL*min] was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion. Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level.
449732|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449733|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449734|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449735|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449736|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449737|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449738|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449739|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449740|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449741|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449812|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449813|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449814|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
453845|NCT00477269|O2|Outcome|Placebo|Placebo
449742|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449743|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449744|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 2|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449745|NCT00489359|O1|Outcome|Pemetrexed/Carboplatin Phase 1|"Pemetrexed (500, 600, 700, 800, or 900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 5 or AUC 6 mg/mL*min) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.~Participant accrual and dose escalations were dependent upon the observed pattern of dose limiting toxicity (DLT). If none of the 3 initial participants of a given dose level experienced a DLT in Cycle 1, enrollment proceeded to the next dose level."
449746|NCT00489359|E7|Reported Event|Pemetrexed 500 + Carboplatin AUC 6 (Phase 2)|"Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
449747|NCT00489359|E6|Reported Event|Pemetrexed 900 + Carboplatin AUC 6 (Phase 1)|"Pemetrexed (900 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle.~Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion."
449748|NCT00489359|E5|Reported Event|Pemetrexed 800 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (800 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449749|NCT00489359|E4|Reported Event|Pemetrexed 700 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (700 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449750|NCT00489359|E3|Reported Event|Pemetrexed 600 + Carboplatin AUC 6 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 6) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449751|NCT00489359|E2|Reported Event|Pemetrexed 600 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (600 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449752|NCT00489359|E1|Reported Event|Pemetrexed 500 + Carboplatin AUC 5 (Phase 1)|Pemetrexed (500 mg/m^2) was administered intravenously over approximately 10 minutes on Day 1 of a 21-day cycle. Carboplatin (AUC 5) was administered intravenously over approximately 30 minutes on Day 1 of a 21-day cycle, beginning approximately 30 minutes after the end of the pemetrexed infusion.
449753|NCT00489268|B6|Baseline|Total|Total of all reporting groups
449754|NCT00489268|B5|Baseline|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449755|NCT00489268|B4|Baseline|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449815|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449816|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449817|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449818|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449819|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449820|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449756|NCT00489268|B3|Baseline|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449757|NCT00489268|B2|Baseline|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449758|NCT00489268|B1|Baseline|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449759|NCT00489268|P5|Participant Flow|Phase II|In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449760|NCT00489268|P4|Participant Flow|Phase I: 12 J/cm^2|In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449761|NCT00489268|P3|Participant Flow|Phase I: 10 J/cm^2|In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449762|NCT00489268|P2|Participant Flow|Phase I: 8 J/cm^2|In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449763|NCT00489268|P1|Participant Flow|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic Intestinal Metaplasia (IM), Low-Grade Dysplasia (LGD) and High-Grade Dysplasia (HGD). The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449764|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449765|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449766|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449821|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449822|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449767|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449768|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449769|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449770|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449771|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449772|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449773|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449774|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449823|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449824|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
453846|NCT00477269|O1|Outcome|STI571|STI571
449775|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449776|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449777|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449778|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449779|NCT00489268|O5|Outcome|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449780|NCT00489268|O4|Outcome|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449781|NCT00489268|O3|Outcome|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449782|NCT00489268|O2|Outcome|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449825|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449826|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449827|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449783|NCT00489268|O1|Outcome|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449784|NCT00489268|E5|Reported Event|Phase II|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. All Halo 360 treatments performed at 10 J/cm^2; All Halo 90 treatments performed at 12 J/cm^2
449785|NCT00489268|E4|Reported Event|Phase I: 12 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 12 J/cm^2. They received a dose of 12 J/cm^2 during the course of this study.
449786|NCT00489268|E3|Reported Event|Phase I: 10 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 10 J/cm^2. They received a dose of 10 J/cm^2 during the course of this study.
449787|NCT00489268|E2|Reported Event|Phase I: 8 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 8 J/cm^2. They received a dose of 8 J/cm^2 during the course of this study.
449788|NCT00489268|E1|Reported Event|Phase I: 6 J/cm^2|The HALO System is an option for eradication of the diseased epithelium of all three subclasses of Barrett's esophagus (non-dysplastic IM, LGD and HGD. The HALO Systems include the circumferential HALO360 Ablation System and the focal HALO90. The Ablation Catheter and Energy Generator work together to deliver energy to the tissue resulting in tissue coagulation. The HALO360 System is designed for longer segment diseased tissue (2 cm or greater) or as an initial treatment to ensure all Barrett’s tissue or buried Barrett’s glands are eliminated within the zone of intestinal metaplasia. The HALO90 System is designed for short segment Barrett’s (2 cm or less) or for follow-up treatment for small Barrett’s islands and tongues. In this group, subjects were randomized to the energy density group of 6 J/cm^2. They received a dose of 6 J/cm^2 during the course of this study.
449789|NCT00489255|B3|Baseline|Total|Total of all reporting groups
449790|NCT00489255|B2|Baseline|Placebo|Placebo : Oral capsule, three times daily.
449791|NCT00489255|B1|Baseline|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449792|NCT00489255|P2|Participant Flow|Tigan:Placebo|Placebo : Oral capsule, three times daily.
449793|NCT00489255|P1|Participant Flow|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449794|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449795|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449796|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449797|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449798|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449799|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449800|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449801|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449802|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449803|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449804|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449805|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449806|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449807|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449829|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449830|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449831|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449832|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449833|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449834|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449835|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449836|NCT00489255|O2|Outcome|Placebo|Placebo : Oral capsule, three times daily.
449837|NCT00489255|O1|Outcome|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449838|NCT00489255|E2|Reported Event|Placebo|Placebo : Oral capsule, three times daily.
449839|NCT00489255|E1|Reported Event|Trimethobenzamide (Tigan®)|Tigan® : Oral capsule, 300mg three times daily.
449840|NCT00489086|B1|Baseline|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
449841|NCT00489086|P1|Participant Flow|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
449842|NCT00489086|O1|Outcome|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
449843|NCT00489086|E1|Reported Event|Tazarotene Cream|This is a 36 month, multi-center, single arm, open label clinical study design
449844|NCT00488865|B1|Baseline|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449845|NCT00488865|P1|Participant Flow|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449846|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449847|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449848|NCT00488865|O1|Outcome|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449849|NCT00488865|E1|Reported Event|Option IVC Filter Device Placement|All participants in the study will have an Option IVC filter placed for the prevention of recurrent pulmonary embolism.
449850|NCT00488826|B4|Baseline|Total|Total of all reporting groups
449851|NCT00488826|B3|Baseline|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
449852|NCT00488826|B2|Baseline|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
449853|NCT00488826|B1|Baseline|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
449854|NCT00488826|P3|Participant Flow|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
449855|NCT00488826|P2|Participant Flow|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
449856|NCT00488826|P1|Participant Flow|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
449857|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
449858|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
449859|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
449860|NCT00488826|O3|Outcome|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
449861|NCT00488826|O2|Outcome|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
449862|NCT00488826|O1|Outcome|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
449863|NCT00488826|E3|Reported Event|DTaP Alone|DTaP administered at 3, 4, and 5 months of age.
449864|NCT00488826|E2|Reported Event|7vPnC + DTaP Concurrently|7vPnC adminstered concurrently with DTaP at 3, 4, and 5 months of age.
449865|NCT00488826|E1|Reported Event|7vPnC Separately|7-valent pneumococcal conjugate vaccine (7vPnC) administered at 3, 4, and 5 months of age. Diphtheria and tetanus toxoids and accelular pertussis vaccine (DTaP) administered at least 7 days after 7vPnC at 3, 4, and 5 months of age.
449866|NCT00488774|B5|Baseline|Total|Total of all reporting groups
449867|NCT00488774|B4|Baseline|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
449868|NCT00488774|B3|Baseline|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
449869|NCT00488774|B2|Baseline|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
449870|NCT00488774|B1|Baseline|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
449871|NCT00488774|P4|Participant Flow|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intavenous infusion was administered at Week 0.
449872|NCT00488774|P3|Participant Flow|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
449873|NCT00488774|P2|Participant Flow|Golimumab 1 Milligram (mg) Per Kilogram (kg)|Golimumab 1 mg per kg intavenous infusion was administered at Week 0.
449874|NCT00488774|P1|Participant Flow|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
449875|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
449876|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0
453847|NCT00477269|O2|Outcome|Placebo|Placebo
449877|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
449878|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
449879|NCT00488774|O4|Outcome|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
449880|NCT00488774|O3|Outcome|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
449881|NCT00488774|O2|Outcome|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
449882|NCT00488774|O1|Outcome|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
449883|NCT00488774|E4|Reported Event|Golimumab 4 mg Per kg|Golimumab 4 mg per kg intravenous infusion was administered at Week 0.
449884|NCT00488774|E3|Reported Event|Golimumab 2 mg Per kg|Golimumab 2 mg per kg intravenous infusion was administered at Week 0.
449885|NCT00488774|E2|Reported Event|Golimumab 1 mg Per kg|Golimumab 1 mg per kg intravenous infusion was administered at Week 0.
449886|NCT00488774|E1|Reported Event|Placebo|Matching placebo for golimumab, intravenous (IV) (through a vein in the arm) infusion administered at Week 0.
449887|NCT00488683|B4|Baseline|Total|Total of all reporting groups
449888|NCT00488683|B3|Baseline|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449889|NCT00488683|B2|Baseline|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449890|NCT00488683|B1|Baseline|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449891|NCT00488683|P3|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449892|NCT00488683|P2|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449893|NCT00488683|P1|Participant Flow|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449894|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449895|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449896|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449897|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449898|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449899|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449900|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
450045|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
449901|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449902|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449903|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449904|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449905|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449906|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449907|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449908|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449909|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449910|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449911|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449912|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449913|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449914|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449915|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449916|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
450046|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
450047|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
449917|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449918|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449919|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449920|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449921|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449922|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449923|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449924|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449925|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449926|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449927|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449928|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449929|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines – 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449930|NCT00488683|O3|Outcome|MenACWY-CRM + Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449931|NCT00488683|O2|Outcome|MenACWY-CRM + Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449932|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449933|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449934|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449935|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449936|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449937|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449938|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449939|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449940|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449941|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449942|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449943|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449944|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449945|NCT00488683|O3|Outcome|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449946|NCT00488683|O2|Outcome|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
449947|NCT00488683|O1|Outcome|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449948|NCT00488683|E3|Reported Event|MenACWY-CRM and Routine Vaccines (Group 3)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months of age.~This group had an additional blood draw at 6-7 days after third dose of MenACWY-CRM."
449949|NCT00488683|E2|Reported Event|MenACWY-CRM and Routine Vaccines (Group 2)|"Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 12 months), and 1 dose each of MMR and Hib (booster) at 13 months.~This group had an additional blood draw at the time of enrollment."
450048|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
450049|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
453848|NCT00477269|O1|Outcome|STI571|STI571
449950|NCT00488683|E1|Reported Event|MenACWY-CRM and Routine Vaccines (Group 1)|Infants received 2 doses of MenACWY-CRM (at 2 and 4 months) as a primary course of vaccination and third dose (at 12 months) as a booster. Infants also received routine vaccines - 3 doses of DTaP-Hib-IPV (at 2, 3, and 4 months), 3 doses of PCV (at 2, 4, and 13 months), and 1 dose each of MMR and Hib (booster) at 13 months.
449951|NCT00488644|B1|Baseline|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
449952|NCT00488644|P1|Participant Flow|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
449953|NCT00488644|O1|Outcome|8 Weeks Post Therapy|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks.
449954|NCT00488644|E1|Reported Event|Levothyroxine + Liothyronine|Levothyroxine 75 mcg by mouth (PO) Daily for 8 Weeks + Liothyronine 15 mcg PO Daily for 8 Weeks
449955|NCT00488631|B7|Baseline|Total|Total of all reporting groups
449956|NCT00488631|B6|Baseline|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
449957|NCT00488631|B5|Baseline|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
449958|NCT00488631|B4|Baseline|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
449959|NCT00488631|B3|Baseline|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449960|NCT00488631|B2|Baseline|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449961|NCT00488631|B1|Baseline|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
449962|NCT00488631|P10|Participant Flow|Golimumab 200 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining on golimumab 200 mg had their dose decreased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
449963|NCT00488631|P9|Participant Flow|Golimumab 100 mg Extension|Participants entered the study extension at Week 54 receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks.
449964|NCT00488631|P8|Participant Flow|Golimumab 50 mg - Extension|Participants entered the study extension at Week 54 receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks.
449965|NCT00488631|P7|Participant Flow|Placebo Extension|Participants entered the study extension at Week 54 receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension.
449966|NCT00488631|P6|Participant Flow|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
449967|NCT00488631|P5|Participant Flow|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized.
449968|NCT00488631|P4|Participant Flow|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
450050|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
450051|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
449969|NCT00488631|P3|Participant Flow|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449970|NCT00488631|P2|Participant Flow|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449971|NCT00488631|P1|Participant Flow|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
449972|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449973|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449974|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
449975|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449976|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449977|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
449978|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449979|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449980|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
450052|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
451211|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
449981|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449982|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449983|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
449984|NCT00488631|O3|Outcome|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449985|NCT00488631|O2|Outcome|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
449986|NCT00488631|O1|Outcome|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous (under the skin) injection matching to golimumab administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52.
449987|NCT00488631|E18|Reported Event|Golimumab 100 mg - 200 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment.
449988|NCT00488631|E17|Reported Event|Golimumab 50 mg - 100 mg Extension|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease. Adverse events are presented from the time of dose adjustment
449989|NCT00488631|E16|Reported Event|Placebo - Golimumab100 mg Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks upon worsening of UC disease in the study extension. Adverse events are presented from the time of dose adjustment.
449990|NCT00488631|E15|Reported Event|Placebo - 50 mg Extension|A single participant entered the study extension receiving placebo subcutaneous injection administered every 4 weeks; and on worsening of UC disease had their dose increased to golimumab 50 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from the time of dose adjustment.
449991|NCT00488631|E14|Reported Event|Golimumab 200 mg Extension|Participants entered the study extension receiving golimumab 200 mg subcutaneous injection administered every 4 weeks. With Amendment 3 participants remaining golimumab 200 mg had their dose descreased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54.
449992|NCT00488631|E13|Reported Event|Golimumab 100 mg Extension|Participants entered the study extension receiving golimumab 100 mg subcutaneous injection administered every 4 weeks; prior to Amendment 3 , those whose UC disease worsened had their dose increased to golimumab 200 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
449993|NCT00488631|E12|Reported Event|Golimumab 50 mg Extension Phase|Participants entered the study extension receiving golimumab 50 mg subcutaneous injection administered every 4 weeks; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
449994|NCT00488631|E11|Reported Event|Placebo Extension|Participants entered the study extension receiving placebo subcutaneous injection administered every 4 weeks until study unblinding and discontinuation of participants remaining on placebo; those whose UC disease worsened had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks in the study extension. Adverse events are presented from Week 54 up to Week 228 or the time of dose adjustment for subjects who increased dose.
449995|NCT00488631|E10|Reported Event|PBO-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631) and had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 on loss of clinical response; not randomized. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
449996|NCT00488631|E9|Reported Event|GLM-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
449997|NCT00488631|E8|Reported Event|PBO-I-nonRsp-Golimumab 100 mg Maintenance|Participants not in clinical response to placebo at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54.
449998|NCT00488631|E7|Reported Event|Placebo Induction Responders (PBO-I-Rsp)-Placebo Maintenance|Participants in clinical response to placebo at Week 6 of an induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and received placebo subcutaneous injection matching to golimumab every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631); not randomized. Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
449999|NCT00488631|E6|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance-Golimumab 200 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 200 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response. Adverse events are presented from the time of dose adjustment onwards up to Week 54.
450000|NCT00488631|E5|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
450001|NCT00488631|E4|Reported Event|GLM-I-Rsp-Placebo Maintenance-Golimumab 100 mg|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631), and had their dose increased to golimumab 100 mg subcutaneous injection every 4 weeks through Week 52 on loss of clinical response Adverse events are presented from the time of dose adjustment onwards up to Week 54.
450002|NCT00488631|E3|Reported Event|GLM-I-Rsp-Golimumab 100 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52 in maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response were re-randomized to receive golimumab 100 mg or 200 mg subcutaneous injection administered every 4 weeks through Week 52 (prior to protocol amendment 3). For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
450003|NCT00488631|E2|Reported Event|GLM-I-Rsp-Golimumab 50 mg Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to golimumab 50 mg subcutaneous injection administered every 4 weeks through Week 52 in C0524T18 (NCT00488631). Adverse events are presented through Week 54.Participants with loss of clinical response were re-randomized to receive golimumab 50 mg or 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose increase.
450004|NCT00488631|E1|Reported Event|Golimumab Induction Responders (GLM-I-Rsp)-Placebo Maintenance|Participants in clinical response to golimumab at Week 6 of induction study C0524T16 (NCT00488774) or C0524T17 (NCT00487539) and randomized to placebo subcutaneous injection matching to golimumab administered every 4 weeks through Week 52 in the maintenance study C0524T18 (NCT00488631). Adverse events are presented through Week 54. Participants with loss of clinical response had their dose increased to golimumab 100 mg subcutaneous injection administered every 4 weeks through Week 52. For participants with dose adjustment, adverse events are presented from Week 0 up to the time of dose adjustment.
450005|NCT00488592|B1|Baseline|WT1/PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
450006|NCT00488592|P1|Participant Flow|WT1/PR1|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
450007|NCT00488592|O1|Outcome|WT1/PR1 Vaccine|Subjects with myeloid malignancies will receive WT1/PR1 vaccine to evaluate immune response to intervention.
450008|NCT00488592|E1|Reported Event|WT1/ PR1 Vaccine|Subjects with myeloid malignacies will receive Wilms' tumor (WT1)/ pathogenesis- related 1 (PR1) vaccine to evaluate an immune response to the intervention
450009|NCT00488514|B1|Baseline|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
450010|NCT00488514|P1|Participant Flow|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium. A single Combination Tablet was supplied for each migraine attack, not to exceed one tablet in 24 hours.
450011|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450012|NCT00488514|O2|Outcome|6 Month Completer Population|Participant in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450013|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450053|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450014|NCT00488514|O3|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450015|NCT00488514|O2|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450016|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet drug and had at least one post-treatment migraine assessment
450017|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450018|NCT00488514|O1|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450019|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450020|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450021|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450022|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450023|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450024|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450025|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450026|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450027|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450028|NCT00488514|O3|Outcome|ITT Population|Participants in the Enrolled Population who took at least one dose of the combination tablet and had at least one post-treatment migraine assessment
450029|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450030|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450031|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
450032|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
450033|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|
450034|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
450035|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
450036|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
450037|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
450038|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
450039|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
450040|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
450041|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
450042|NCT00488514|O2|Outcome|15-17 Years|Participants who were 15-17 years old at the time of the Screening Visit
450043|NCT00488514|O1|Outcome|12-14 Years|Participants who were 12-14 years old at the time of the Screening Visit
450044|NCT00488514|O3|Outcome|12-17 Years|All participants in the Enrolled Population who took at least one dose of study drug
450054|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450055|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450056|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450057|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450058|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450059|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450060|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450061|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet , completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450062|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450063|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450064|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450065|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium
450066|NCT00488514|O1|Outcome|85 mg Sumatriptan/500 mg Naproxen Sodium|Combination Tablet: 85 milligrams (mg) sumatriptan and 500 mg naproxen sodium.
450067|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450068|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450069|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450070|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450071|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450072|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450073|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450074|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450075|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450076|NCT00488514|O3|Outcome|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450077|NCT00488514|O2|Outcome|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450078|NCT00488514|O1|Outcome|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450079|NCT00488514|E3|Reported Event|12 Month Completer Population|Participants in the Enrolled and 6 Month Completer Populations who completed at least one study visit in the second six-month period (9- or 12-month visit), provided data for at least 12 migraines, and who continued in the study for at least 346 days. The 12 Month Completer Population is a subset of those participants who completed or remained in the study for at least 346 days.
450080|NCT00488514|E2|Reported Event|6 Month Completer Population|Participants in the Enrolled Population who were treated with at least one dose of the combination tablet, completed at least one study visit (3- or 6-month visit), provided data for at least 6 migraines, and who continued in the study for at least 166 days
450081|NCT00488514|E1|Reported Event|Safety Population|Participants in the Enrolled Population who took at least one dose of the combination tablet
450082|NCT00488488|B1|Baseline|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450083|NCT00488488|P1|Participant Flow|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450084|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450085|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450086|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450087|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450088|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450089|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450090|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450091|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450092|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450093|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450094|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450095|NCT00488488|O1|Outcome|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450096|NCT00488488|E1|Reported Event|Tygacil|Tygacil prescribed according to product label; recommended dose 100 milligrams (mg) initial dose, then 50 mg every 12 hours; maximum dose 100 mg per day
450097|NCT00488475|B1|Baseline|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450098|NCT00488475|P1|Participant Flow|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450099|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450100|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450101|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450102|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450103|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450104|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450105|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450106|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450107|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450108|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450109|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450110|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450111|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450112|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450113|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450114|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450115|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450116|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450117|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450118|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450119|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450120|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450121|NCT00488475|O1|Outcome|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450122|NCT00488475|E1|Reported Event|Etanercept|Participants greater than or equal to (>=) 18 years of age, who had confirmed diagnosis of moderate to severe rheumatoid arthritis (RA) and received etanercept (Enbrel) as per German Summary of Product Characteristics (SPC), were observed prospectively up to Week 52.
450123|NCT00488345|B4|Baseline|Total|Total of all reporting groups
450124|NCT00488345|B3|Baseline|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450125|NCT00488345|B2|Baseline|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450126|NCT00488345|B1|Baseline|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450127|NCT00488345|P3|Participant Flow|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450128|NCT00488345|P2|Participant Flow|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450129|NCT00488345|P1|Participant Flow|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450130|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
450131|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
450132|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450133|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450134|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450135|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg, 1 mg/kg, 1.25 mg/kg|0.75, 1 mg/kg, and 1.25 milligram per kilogram (mg/kg) intravenous (IV) infusions every 12 hours
450136|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450137|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450138|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450139|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450140|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450141|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
451212|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
450142|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450143|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450144|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450145|NCT00488345|O3|Outcome|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450146|NCT00488345|O2|Outcome|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450147|NCT00488345|O1|Outcome|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450148|NCT00488345|E3|Reported Event|Tigecycline 1.25 mg/kg|1.25 milligram per kilogram (mg/kg) IV infusion every 12 hours
450149|NCT00488345|E2|Reported Event|Tigecycline 1 mg/kg|1 milligram per kilogram (mg/kg) IV infusion every 12 hours
450150|NCT00488345|E1|Reported Event|Tigecycline 0.75 mg/kg|0.75 milligram per kilogram (mg/kg) intravenous (IV) infusion every 12 hours
450151|NCT00488319|B4|Baseline|Total|Total of all reporting groups
450152|NCT00488319|B3|Baseline|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450153|NCT00488319|B2|Baseline|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450154|NCT00488319|B1|Baseline|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450155|NCT00488319|P3|Participant Flow|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450156|NCT00488319|P2|Participant Flow|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450157|NCT00488319|P1|Participant Flow|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450158|NCT00488319|O4|Outcome|Total|
450159|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450160|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450161|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450162|NCT00488319|O4|Outcome|Total|
450163|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450164|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450165|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450166|NCT00488319|O4|Outcome|Total|
450167|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450168|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450169|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450170|NCT00488319|O4|Outcome|Total|
450171|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450172|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450173|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450174|NCT00488319|O4|Outcome|Total|
450175|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450176|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450177|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450178|NCT00488319|O4|Outcome|Total|
450179|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450180|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450181|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450182|NCT00488319|O4|Outcome|Total|
450183|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450184|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450185|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450186|NCT00488319|O4|Outcome|Total|
450187|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450188|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450189|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450190|NCT00488319|O4|Outcome|Total|
450191|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450192|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450193|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450194|NCT00488319|O4|Outcome|Total|
450195|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450196|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450197|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450198|NCT00488319|O4|Outcome|Total|
450199|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450200|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450201|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450202|NCT00488319|O4|Outcome|Total|
450203|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450204|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450205|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450206|NCT00488319|O4|Outcome|Total|
450207|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450208|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450209|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450210|NCT00488319|O4|Outcome|Total|
450211|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450212|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450213|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450214|NCT00488319|O4|Outcome|Total|
450215|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450216|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450217|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450218|NCT00488319|O4|Outcome|Total|
450219|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450220|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450221|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450222|NCT00488319|O4|Outcome|Total|
450223|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450224|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450225|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450226|NCT00488319|O4|Outcome|Total|
450227|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450228|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450229|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450230|NCT00488319|O4|Outcome|Total|
450231|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450232|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450233|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450234|NCT00488319|O4|Outcome|Total|
450235|NCT00488319|O3|Outcome|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450236|NCT00488319|O2|Outcome|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450237|NCT00488319|O1|Outcome|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450238|NCT00488319|E3|Reported Event|Paliperidone (No Double-blind)/Paliperidone|Patients in this group were directly enrolled into the study and started with an oral dose of 6 mg tablets daily. The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450239|NCT00488319|E2|Reported Event|Paliperidone (Double-blind)/Paliperidone|Patients in this group were previously assigned to paliperidone extended-release in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450240|NCT00488319|E1|Reported Event|Placebo/Paliperidone|Patients in this group were previously assigned to placebo in the R076477PSZ3001 (NCT00518323) study. They started with an oral dose of 6 mg tablets daily, regardless of prior treatment assignment in R076477PSZ3001 (NCT00518323). The initial 6 mg daily dose was increased in increments of 3 mg, not more frequently than once every 5 days until the maximum dose of 12 mg daily was reached. If 12 mg was not well tolerated, then the dose could be reduced down to 9 mg daily. Alternatively the dose could be decreased to 3 mg or 1.5 mg daily, if the initial 6 mg dose was not well tolerated.
450241|NCT00488293|B3|Baseline|Total|Total of all reporting groups
450242|NCT00488293|B2|Baseline|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450243|NCT00488293|B1|Baseline|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450244|NCT00488293|P2|Participant Flow|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450245|NCT00488293|P1|Participant Flow|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450246|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450247|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450248|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450249|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450250|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450251|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450252|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450253|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450254|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450255|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450256|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450257|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450258|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450259|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450260|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450261|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450262|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450263|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450264|NCT00488293|O2|Outcome|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450265|NCT00488293|O1|Outcome|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450266|NCT00488293|E2|Reported Event|Conventional Referrals|"Conventional consult process~Conventional consult process: Standard electronic consult"
450267|NCT00488293|E1|Reported Event|Teledermatology Referrals|"Store and forward teledermatology consult process~Store and forward teledermatology: Standard electronic consult, standardized history, and image set"
450268|NCT00488059|B1|Baseline|Phase 1: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450269|NCT00488059|P3|Participant Flow|Phase II - Arm B|Phase I then enfuvirtide 180 mg SC QD (2 x 90-mg injections) + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
450270|NCT00488059|P2|Participant Flow|Phase II - Arm A|Phase I then enfuvirtide 90 mg SC BID + RAL 400 mg PO BID + OB (with at least 1 fully active ARV agent excluding NRTIs)
450271|NCT00488059|P1|Participant Flow|Phase I|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450272|NCT00488059|O3|Outcome|Phase II - Arm B|Phase I then ENF 180 mg SC QD
450273|NCT00488059|O2|Outcome|Phase II - Arm A|Phase I then ENF 90 mg SC BID
450274|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450275|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450289|NCT00487981|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
450290|NCT00487981|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
450291|NCT00487942|B5|Baseline|Total|Total of all reporting groups
450276|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450277|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450278|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450279|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450280|NCT00488059|O2|Outcome|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm B: Phase I then ENF 180mg SC QD): ENF 180 mg SC once daily (QD) + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450281|NCT00488059|O1|Outcome|Phase II Arm A: Phase I Then ENF 90 mg SC BID|"(Phase 1: ENF 90 mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I+ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450282|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450283|NCT00488059|O1|Outcome|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450284|NCT00488059|E3|Reported Event|Phase II Arm B: Phase I Then ENF 180mg SC QD|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized~(Phase II Arm B: Phase I then ENF 180mg SC once daily (QD)): ENF 180 mg SC QD + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450285|NCT00488059|E2|Reported Event|Phase II Arm A: Phase I Then ENF 90mg SC BID|"(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).~In the randomized comparator phase Phase II of the trial– (Day II-1 through Week II-16): Virologic responders confirmed HIV-1 RNA ≤50 copies/mL)from Phase I were randomized to~(Phase II Arm A: Phase I then ENF 90mg SC BID): ENF 90 mg SC BID + RAL 400 mg PO BID + OB with at least 1 fully active ARV agent excluding NRTIs."
450286|NCT00488059|E1|Reported Event|Phase I: ENF 90mg SC BID|(Phase 1: ENF 90mg SC BID): In the first phase or cohort phase of day I-1 through Week I-12 of the trial all patients received enfuvirtide (ENF) 90 mg subcutaneously (SC) twice daily (BID) + Isentress® [raltegravir] (RAL) 400-mg orally (PO) BID + optimized background (OB) with at least 1 fully active antiretroviral (ARV) agent excluding nucleoside reverse transcriptase inhibitor (NRTIs).
450287|NCT00487981|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
450288|NCT00487981|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|Spinal Cord Stimulation (SCS) Treatment Group
451213|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
450292|NCT00487942|B4|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450293|NCT00487942|B3|Baseline|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450294|NCT00487942|B2|Baseline|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450295|NCT00487942|B1|Baseline|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450296|NCT00487942|P4|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450297|NCT00487942|P3|Participant Flow|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450298|NCT00487942|P2|Participant Flow|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450299|NCT00487942|P1|Participant Flow|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450300|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450301|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450302|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450303|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450304|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450305|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450306|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450307|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450308|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450309|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450310|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450696|NCT00487721|B2|Baseline|Control|Subjects in the control arm did not receive any treatment or placebo.
451214|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
450311|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450312|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450313|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450314|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450315|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450316|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450317|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450318|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450319|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450320|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450321|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450322|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450323|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450324|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450325|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450326|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450327|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450328|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450329|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450330|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450331|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450332|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450333|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450334|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450335|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450336|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450337|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450338|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450339|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450340|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450341|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450342|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450343|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450344|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450345|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450346|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450347|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450348|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450349|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450350|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450351|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450352|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450353|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450354|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450355|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450356|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450357|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450358|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450359|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450360|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450361|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450362|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450363|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450364|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450365|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450366|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450367|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450368|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450369|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450370|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450371|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450372|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450373|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450374|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450375|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450376|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450377|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450378|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450379|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450380|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450381|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450382|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450383|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450384|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450385|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450386|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450387|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450388|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450389|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450390|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450391|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450392|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450393|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450394|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450395|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450396|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450397|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450398|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450399|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450400|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450401|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450402|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450403|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450404|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450405|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450406|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450407|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450408|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450409|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450410|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450411|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450412|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450413|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450414|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450415|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450416|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450417|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450418|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450419|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450420|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450421|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450422|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450423|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450424|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450425|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450426|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450427|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450428|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450429|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450430|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450431|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450432|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450433|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450434|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450435|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450436|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450437|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450438|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450439|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450440|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450441|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450442|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450443|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450444|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450445|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450446|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450447|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450448|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450449|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450450|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450451|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450452|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450453|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450454|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450455|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450456|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450457|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450458|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450459|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450460|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450461|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450462|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450463|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450464|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450465|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450466|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450467|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450468|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450469|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450470|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450471|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450472|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450473|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450474|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450475|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450476|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450477|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450478|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450479|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450480|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450481|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450482|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450483|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450484|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450485|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450486|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450487|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450488|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450489|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450490|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450491|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450492|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450493|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450494|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450495|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450496|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450497|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450498|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450499|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450500|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450501|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450502|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450503|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450504|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450505|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450506|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450507|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450508|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450509|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450510|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450511|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450512|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450513|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450514|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450515|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450516|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450517|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450518|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450519|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450520|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450521|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450522|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450523|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450524|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450525|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450526|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450527|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450528|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450529|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450530|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450531|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450532|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450533|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450534|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450535|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450536|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450537|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450538|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450539|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450540|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450541|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450542|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450543|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450544|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450545|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450546|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450547|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450548|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450549|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450550|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450551|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450552|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450553|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450554|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450555|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450556|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450557|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450558|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450559|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450560|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450561|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450562|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450563|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450564|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450565|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450566|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450567|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450568|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450569|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450570|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450571|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450572|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450573|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450574|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450575|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450576|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450577|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450578|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450579|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450580|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450581|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450582|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450583|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450584|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450585|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450586|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450587|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450588|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450589|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450590|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450591|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450592|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450593|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450594|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450595|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450596|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450597|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450598|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450599|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450600|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450601|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450602|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450603|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450604|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450605|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450606|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450607|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450608|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450609|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450610|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450611|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450612|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450613|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450614|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450615|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450616|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450617|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450618|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450619|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450620|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450621|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450622|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450623|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450624|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450625|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450626|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450627|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450628|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450629|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450630|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450631|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450632|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450633|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450634|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450635|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450636|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450637|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450638|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450639|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450640|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450641|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450642|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450643|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450644|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450645|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450646|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450647|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450648|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450649|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450650|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450651|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450652|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450653|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450654|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450655|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450656|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450657|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450658|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450659|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450660|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450661|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450662|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450663|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450664|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450665|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450666|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450667|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450668|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450669|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450670|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450671|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450672|NCT00487942|O4|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450673|NCT00487942|O3|Outcome|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450674|NCT00487942|O2|Outcome|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450675|NCT00487942|O1|Outcome|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450676|NCT00487942|E4|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets for those patients administered placebo during the double blind treatment period.
450677|NCT00487942|E3|Reported Event|Armodafinil 200 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in 50 mg increments (an additional 50 mg armodafinil tablet and one less placebo tablet), as appropriate, on days 2, 4, and 6 to the randomized dosage of 200 mg/day (four 50 mg armodafinil tablets and no placebo tablets). Patients remained at their randomized dosage for the duration of the study.
450678|NCT00487942|E2|Reported Event|Armodafinil 100 mg/Day|Patients took 4 tablets orally, once daily in the morning. Treatment with study drug began at 50 mg/day (one 50 mg armodafinil tablet and three placebo tablets) and was titrated in a 50 mg increment to the randomized dosage of 100 mg/day (two 50 mg armodafinil tablets and two placebo tablets) on day 2. Patients remained at their randomized dosage for the duration of the study.
450679|NCT00487942|E1|Reported Event|Armodafinil 50 mg/Day|Patients took 4 tablets orally, once daily in the morning. The 4 tablets consumed consisted of one 50 mg active tablet of armodafinil and three placebo tablets. Patients remained at their randomized dosage for the duration of the study.
450680|NCT00487825|B3|Baseline|Total|Total of all reporting groups
450681|NCT00487825|B2|Baseline|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450682|NCT00487825|B1|Baseline|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
450683|NCT00487825|P2|Participant Flow|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450684|NCT00487825|P1|Participant Flow|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
450685|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450686|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
450687|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450688|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
450689|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450690|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
450691|NCT00487825|O2|Outcome|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450692|NCT00487825|O1|Outcome|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg-15 mg weekly.
450693|NCT00487825|E2|Reported Event|Methotrexate|Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly. Intravenous (IV) Placebo Solution, given in the same mode of administration as the canakinumab solution.
450694|NCT00487825|E1|Reported Event|Canakinumab + Methotrexate|Canakinumab, human anti-interleukin-1beta monoclonal antibody plus Methotrexate (MTX). Intravenous (IV) Infusion of 600mg canakinumab on Day 1, 15 continuing every 4 weeks up to week 26. Methotrexate is given as variable dosing regimen of 7.5 mg–15 mg weekly.
450695|NCT00487721|B3|Baseline|Total|Total of all reporting groups
450697|NCT00487721|B1|Baseline|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
450698|NCT00487721|P2|Participant Flow|Control|Subjects in the control arm did not receive any treatment or placebo.
450699|NCT00487721|P1|Participant Flow|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
450700|NCT00487721|O1|Outcome|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
450701|NCT00487721|E2|Reported Event|Control|Subjects in the control arm did not receive any treatment or placebo.
450702|NCT00487721|E1|Reported Event|Silibin-Phytosome|Subjects in this group received silybin-phytosome for 2–10 weeks, depending on the time from enrollment until the time of the prostatectomy. The dose of silybin-phytosome was 13 g daily in three divided doses.
450703|NCT00487695|B1|Baseline|All Study Participants|Patients received both procedures (CLE and standard EGD), so baseline characteristics are reported for the group
450704|NCT00487695|P2|Participant Flow|Standard EGD Followed by CLE|Patients in this group were randomized to have standard EGD followed by CLE 6 weeks later
450705|NCT00487695|P1|Participant Flow|CLE Followed by Standard EGD|Patients randomized to either CLE or standard endoscopy first. The other procedure was then performed 6 weeks later. This group was randomized to CLE first, followed by standard endoscopy
450706|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450707|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450708|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450709|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450710|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450711|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450712|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450713|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450714|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450715|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450716|NCT00487695|O2|Outcome|Standard Endoscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450717|NCT00487695|O1|Outcome|Confocal Laser Endomicroscopy|all patients had both confocal endomicroscopy and standard endoscopy in crossover fashion. For outcome, will compare the results of CLE and standard endoscopy.
450718|NCT00487695|E2|Reported Event|Standard EGD|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
450719|NCT00487695|E1|Reported Event|Confocal Laser Endomicroscopy|Adverse even reporting is being done by procedure type (ie confocal laser endomicroscopy vs. standard endoscopy)
450720|NCT00487669|B1|Baseline|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
450721|NCT00487669|P1|Participant Flow|Paclitaxel Poliglumex With Pemetrexed|The first 6 eligible patients will be enrolled at a dose of 135 mg/m2 paclitaxel poliglumex in combination with 500 mg/m2 of pemetrexed. Patients who experience disease progression without dose-limiting adverse events after the initial cycle will be replaced. Dose escalation to the next dose level can occur provided that no more than 1 of 6 patients experience in initial dose limiting toxicity (IDLT) following 2 cycles of therapy. If ≥ 2 of 6 patients experience IDLTs at the 135 mg/m2 dose, the maximally tolerated dose (MTD) was surpassed and the study will be discontinued.
450722|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
450723|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
450724|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
450725|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
450726|NCT00487669|O2|Outcome|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
450727|NCT00487669|O1|Outcome|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
450728|NCT00487669|E2|Reported Event|Level 2|Dose escalation to the next dose level, paclitaxel poliglumex at 175 mg/m2 and pemetrexed at 500 mg/m2, occurred when no more than 1 of 6 patients experience initial dose limiting toxicity (IDLT) following 2 cycles of therapy on the first dose level. If ≥ 2 of 6 patients experience IDLTs, the maximally tolerated dose (MTD) would have been surpassed and the study stopped.
450729|NCT00487669|E1|Reported Event|Level 1|The first 6 eligible patients were enrolled at a dose of 135 mg/m2 of paclitaxel poliglumex administered intravenously over 10-20 minutes followed by 500 mg/m2 of pemetrexed administered intravenously over 10 minutes every 3 weeks.
450730|NCT00487578|B3|Baseline|Total|Total of all reporting groups
450731|NCT00487578|B2|Baseline|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450732|NCT00487578|B1|Baseline|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450733|NCT00487578|P2|Participant Flow|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450734|NCT00487578|P1|Participant Flow|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450735|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450736|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450737|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450738|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450739|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450740|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450741|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450742|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450743|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450744|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450745|NCT00487578|O2|Outcome|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450746|NCT00487578|O1|Outcome|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450747|NCT00487578|E2|Reported Event|Placebo Matching Naratriptan|placebo matching naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450748|NCT00487578|E1|Reported Event|Active Naratriptan|Naratriptan 2.5 mg tablet twice daily (bid) x 30 days
450749|NCT00487565|B1|Baseline|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
450750|NCT00487565|P1|Participant Flow|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
450751|NCT00487565|O1|Outcome|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
450752|NCT00487565|E1|Reported Event|LCS Complete Posterior Stabilized Knee Implant|Total knee arthroplasty with a posterior stabilized implant
450753|NCT00487552|B1|Baseline|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
450754|NCT00487552|P1|Participant Flow|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
450755|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD)|Magnetic Anastomosis Device (MAD) used for palliative treatment of gastric outlet obstruction.
450756|NCT00487552|O1|Outcome|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
450757|NCT00487552|E1|Reported Event|Magnetic Anastomosis Device (MAD) With Stent|Magnetic Anastomosis Device used with gastro-jejunal or duodenal stent for palliative treatment of gastric outlet obstruction.
450758|NCT00487539|B5|Baseline|Total|Total of all reporting groups
450759|NCT00487539|B4|Baseline|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450760|NCT00487539|B3|Baseline|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450761|NCT00487539|B2|Baseline|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
450762|NCT00487539|B1|Baseline|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450763|NCT00487539|P4|Participant Flow|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 200 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
450764|NCT00487539|P3|Participant Flow|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and the dose was decreased to 100 mg at Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
450765|NCT00487539|P2|Participant Flow|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
450766|NCT00487539|P1|Participant Flow|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2. This dosing regimen was selected for the efficacy analysis (only in newly enrolled participants following dose-selection, as per planned analysis).
450767|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450768|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450769|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450770|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450771|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450772|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450773|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450774|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450775|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450776|NCT00487539|O3|Outcome|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450777|NCT00487539|O2|Outcome|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450778|NCT00487539|O1|Outcome|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450779|NCT00487539|E4|Reported Event|Golimumab 400 mg -> 200 mg|Golimumab 400 mg subcutaneous injection was administered at Week 0 and dose was decreased to 200 mg at Week 2.
450780|NCT00487539|E3|Reported Event|Golimumab 200 mg -> 100 mg|Golimumab 200 mg subcutaneous injection was administered at Week 0 and dose was decreased to 100 mg at Week 2.
450781|NCT00487539|E2|Reported Event|Golimumab 100 mg -> 50 mg|Golimumab 100 milligram (mg) subcutaneous injection was administered at Week 0 and dose was decreased to 50 mg at Week 2.
450782|NCT00487539|E1|Reported Event|Placebo|Placebo subcutaneous injection (given under the skin by way of a needle) matched to golimumab administered at Week 0 and Week 2.
450783|NCT00487461|B4|Baseline|Total|Total of all reporting groups
450784|NCT00487461|B3|Baseline|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450785|NCT00487461|B2|Baseline|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450786|NCT00487461|B1|Baseline|Control Group|"Placebo tablet~Placebo: Placebo tablet"
450787|NCT00487461|P3|Participant Flow|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450788|NCT00487461|P2|Participant Flow|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450789|NCT00487461|P1|Participant Flow|Control Group|"Placebo tablet~Placebo: Placebo tablet"
450790|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450791|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450792|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
450793|NCT00487461|O3|Outcome|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450794|NCT00487461|O2|Outcome|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450795|NCT00487461|O1|Outcome|Control Group|"Placebo tablet~Placebo: Placebo tablet"
450796|NCT00487461|E3|Reported Event|Study Group #2|"Simvastatin 80 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450797|NCT00487461|E2|Reported Event|Study Group #1|"Simvastatin 40 mg~Simvastatin: Comparing two doses of Simvastatin to placebo"
450798|NCT00487461|E1|Reported Event|Control Group|"Placebo tablet~Placebo: Placebo tablet"
450799|NCT00487435|B1|Baseline|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
450800|NCT00487435|P1|Participant Flow|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
450801|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
450802|NCT00487435|O1|Outcome|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
450803|NCT00487435|E1|Reported Event|Tapentadol (CG5503) Extended Release (ER)|Tapentadol (CG5503) extended release (ER) 100 to 250mg oral tablet twice daily (BID) for up to one year
450804|NCT00487396|B1|Baseline|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
450805|NCT00487396|P1|Participant Flow|SB Capsule Then Standard Ileocolonoscopy|Capsule endoscopy was ingested .The purpose was to detect patients with crohn Patients subsequently had standard ileocolonoscopy and small bowel follow through as comparison.
450806|NCT00487396|O2|Outcome|Small Bowel Follow Through(SBFT) Followed by Ileo-colonoscopy|Patients subsequently had SBFT followed by ileo-colonoscopy .
450807|NCT00487396|O1|Outcome|PillCam SB Followed by Ileo Colonoscopy|Ingestible capsule equipped with an endoscope with one imagers, before ileo-colonoscopy.
450808|NCT00487396|E2|Reported Event|Adverse Events Related to Capsule|AE related to the capsule endoscopy procedure
450809|NCT00487396|E1|Reported Event|Adverse Events Related to Ileocolonoscopy|AE related to the ileocolonoscopy procedure
450810|NCT00487279|B3|Baseline|Total|Total of all reporting groups
450811|NCT00487279|B2|Baseline|Control Group|Medical therapy alone
450812|NCT00487279|B1|Baseline|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
450813|NCT00487279|P2|Participant Flow|Control Group|Medical therapy alone
450814|NCT00487279|P1|Participant Flow|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
450815|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
450816|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
450817|NCT00487279|O2|Outcome|Control Group|Medical therapy alone
450818|NCT00487279|O1|Outcome|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
450819|NCT00487279|E2|Reported Event|Control Group|Medical therapy alone
450820|NCT00487279|E1|Reported Event|ICD Group|ICD (Implantable Cardioverter Defibrillator)in combination with medical therapy
450821|NCT00487240|B3|Baseline|Total|Total of all reporting groups
450822|NCT00487240|B2|Baseline|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450823|NCT00487240|B1|Baseline|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450824|NCT00487240|P2|Participant Flow|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450825|NCT00487240|P1|Participant Flow|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450826|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450827|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450828|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450829|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450830|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450831|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450832|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450833|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450834|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450835|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450836|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450837|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450838|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450839|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450840|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450841|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450842|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450843|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450844|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450845|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450846|NCT00487240|O2|Outcome|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450847|NCT00487240|O1|Outcome|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450848|NCT00487240|E2|Reported Event|Detemir|Patient specific dose insulin Levemir (detemir) twice daily (BID) subcutaneous (SC) injection x 32 weeks
450849|NCT00487240|E1|Reported Event|Insulin Lispro Protamine Suspension|Patient specific dose insulin lispro protamine suspension, twice daily (BID), within 15 minutes before meals, subcutaneous (SC) injection x 32 weeks
450850|NCT00487188|B3|Baseline|Total|Total of all reporting groups
450851|NCT00487188|B2|Baseline|HAART|Participants received highly active antiretroviral treatment.
450852|NCT00487188|B1|Baseline|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450853|NCT00487188|P3|Participant Flow|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
450854|NCT00487188|P2|Participant Flow|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
451215|NCT00486434|E2|Reported Event|Placebo Arm|1 SMC021 Placebo tablet twice daily
450855|NCT00487188|P1|Participant Flow|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
450856|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450857|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450858|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
450859|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
450860|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
450861|NCT00487188|O3|Outcome|HAART (ENF Removed)|Participants who had received ENF + HAART during the Induction Phase and responded to treatment by Week 24 continued to receive HAART alone during the Maintenance Phase, for a total of 48 weeks of treatment.
450862|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
450863|NCT00487188|O1|Outcome|ENF + HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment during the Induction and Maintenance Phase for up to 48 weeks of treatment.
450864|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450865|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
450866|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450867|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance Phase from the ENF+HAART Induction Phase, regardless of which arm they were randomized to at BL2."
450868|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450869|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
450870|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450871|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
450872|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450873|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who entered the Maintenance phase from the ENF+HAART Induction phase, regardless of which arm they were randomized to at BL2."
450874|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment during both the Induction and Maintenance Phase.
450875|NCT00487188|O1|Outcome|ENF+HAART|"Participants received enfuvirtide (ENF) 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment (HAART) in the Induction Phase. In the Maintenance Phase, participants either continued to receive ENF+HAART or HAART alone.~This group contains all patients who were randomized to ENF+HAART at BL1 and follows the patients throughout 48 weeks, regardless of which arm they were randomized to at BL2."
450876|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450877|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450878|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450879|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450880|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450881|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450882|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450883|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450884|NCT00487188|O2|Outcome|HAART|Participants received highly active antiretroviral treatment.
450885|NCT00487188|O1|Outcome|ENF+HAART|Participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment.
450886|NCT00487188|E5|Reported Event|Maintenance Phase: HAART|During the Maintenance Phase, participants who had received HAART alone and who responded to treatment during the Induction Phase continued to receive highly active antiretroviral treatment for up to 48 weeks of total treatment.
450887|NCT00487188|E4|Reported Event|Maintenance Phase: HAART (ENF Removed)|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive HAART alone during the Maintenance Phase, for up to a total of 48 weeks treatment.
450888|NCT00487188|E3|Reported Event|Maintenance Phase: ENF + HAART|During the Maintenance Phase, participants who had received ENF+HAART and who responded to treatment during the Induction Phase continued to receive enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for up to 48 weeks of total treatment.
450889|NCT00487188|E2|Reported Event|Induction Phase: HAART|During the Induction Phase participants received highly active antiretroviral treatment for a maximum of 32 weeks.
450890|NCT00487188|E1|Reported Event|Induction: ENF+HAART|During the Induction Phase participants received enfuvirtide 90 mg subcutaneously twice a day in combination with highly active antiretroviral treatment for a maximum of 32 weeks.
450891|NCT00487162|B3|Baseline|Total|Total of all reporting groups
450892|NCT00487162|B2|Baseline|Intensive Glycemic Control|In this treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50mL of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg/dL and will be adjusted to maintain the blood glucose level between 80 and 110 mg/dL.
450893|NCT00487162|B1|Baseline|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200 mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
450894|NCT00487162|P2|Participant Flow|Intensive Glycemic Control|In the intensive treatment group, continuous insulin infusion (50 IU of Novolin R [Novo Nordisk]) in 50ml of 0.9% saline via infusion pump will be started when the blood glucose level exceeds 110 mg / dL on two consecutive samples and will be adjusted to maintain the blood glucose level between 80 and 110 mg / dL. Adjustments will be made according to the University Hospital's ICU Adult Insulin Infusion Protocol - modified 10/1/07 (Appendix A). When the blood glucose level falls below 80 mg / dL, the insulin infusion will be tapered and discontinued. For patients going to the ICU after surgery, insulin infusions will be continued according to the University Hospital's ICU Adult Insulin Infusion Protocol under the direction of the ICU staff. For patients not being to the ICU after surgery, insulin infusions will be tapered to off after the final hourly blood glucose determination at three hours after the completion of surgery.
450895|NCT00487162|P1|Participant Flow|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to thie care provider discretion.
450896|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
450897|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
450898|NCT00487162|O2|Outcome|Conventional Glycemic Control|conventional glycemic control: Novo regular insulin administered when glucose level exceeded 200 mg/dl and titrated to maintain level between 180-200 mg/dl
450899|NCT00487162|O1|Outcome|Strict Glycemic Control|strict glycemic control: intravenous insulin titrated every 30 minutes to serum glycemic level of 80-100mg/dl
450900|NCT00487162|E2|Reported Event|Intensive Glycemic Control|Subjects randomized to this group had glucose levels monitored hourly and when >110mg/dL an insulin drip was initiated to maintain glucose levels between 80-110
450901|NCT00487162|E1|Reported Event|Conventional Glycemic Control|Subjects randomized to this study arm had their glucose levels monitored hourly and if the result was greater than 200mg/dL their anesthesia care provider was notified. The subject was treated as to their care provider discretion.
450902|NCT00487084|B4|Baseline|Total|Total of all reporting groups
450903|NCT00487084|B3|Baseline|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450904|NCT00487084|B2|Baseline|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450905|NCT00487084|B1|Baseline|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450906|NCT00487084|P3|Participant Flow|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450907|NCT00487084|P2|Participant Flow|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450908|NCT00487084|P1|Participant Flow|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450909|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450910|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450911|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450912|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450913|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450914|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
451053|NCT00486863|B1|Baseline|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
450915|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450916|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450917|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450918|NCT00487084|O3|Outcome|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450919|NCT00487084|O2|Outcome|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450920|NCT00487084|O1|Outcome|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450921|NCT00487084|E3|Reported Event|Saline - Lidocaine - Morphine (SLM)|Saline administered 30 minutes prior to lidocaine to achieve a T4 anesthesia level. Morphine administered at skin incision.
450922|NCT00487084|E2|Reported Event|Saline-2 Chloroprocaine - Morphine (SCM)|saline will be administered 30 min prior to epidural anesthesia; 2-chloroprocaine will be used to achieve a T4 level; morphine will be administered at skin incision
450923|NCT00487084|E1|Reported Event|Morphine - 2 Chloroprocaine - Saline (MCS)|morphine will be administered 30 min prior to epidural anesthesia; 2CP will be used to achieve a T4 level; saline will be administered at skin incision
450924|NCT00486954|B5|Baseline|Total|Total of all reporting groups
450925|NCT00486954|B4|Baseline|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450926|NCT00486954|B3|Baseline|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450927|NCT00486954|B2|Baseline|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
450928|NCT00486954|B1|Baseline|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
450929|NCT00486954|P5|Participant Flow|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450930|NCT00486954|P4|Participant Flow|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450931|NCT00486954|P3|Participant Flow|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
450932|NCT00486954|P2|Participant Flow|Lapatinib Plus Paclitaxel in Partial Gastrectomy Participants|Participants with partial gastrectomy (which includes preservation of the pylorus) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2. Partial gastrectomy (pylorus preserved) is very rare population in Japan. As a result, no such participants were recruited into this cohort.
450933|NCT00486954|P1|Participant Flow|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
450934|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450935|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450936|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450937|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450938|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450939|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450940|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451094|NCT00486863|E2|Reported Event|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
450941|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450942|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450943|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450944|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450945|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450946|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450947|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450948|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450949|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450950|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450951|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450952|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450953|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450954|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450955|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450956|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450957|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450958|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450959|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450960|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450961|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450962|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450963|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450964|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450965|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450966|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450967|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450968|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451095|NCT00486863|E1|Reported Event|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451096|NCT00486837|B3|Baseline|Total|Total of all reporting groups
450969|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450970|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450971|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450972|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450973|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450974|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450975|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450976|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450977|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450978|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450979|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450980|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450981|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450982|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450983|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450984|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450985|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450986|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450987|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450988|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450989|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450990|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450991|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450992|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450993|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450994|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450995|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450996|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451097|NCT00486837|B2|Baseline|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
451216|NCT00486434|E1|Reported Event|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
450997|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450998|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
450999|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451000|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451001|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451002|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451003|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451004|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451005|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451006|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451007|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451008|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451009|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451010|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451011|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451012|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451013|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451014|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451015|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451098|NCT00486837|B1|Baseline|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
451016|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451017|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451018|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451019|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451020|NCT00486954|O2|Outcome|Paclitaxel Alone|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451021|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451022|NCT00486954|O2|Outcome|Lapatinib Plus Paclitaxel in Gastrectomy Participants|Participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451023|NCT00486954|O1|Outcome|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|Participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451024|NCT00486954|E4|Reported Event|Paclitaxel Alone in Randomized Part|Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451025|NCT00486954|E3|Reported Event|Lapatinib Plus Paclitaxel in Randomized Part|Participants received 1500 mg of oral lapatinib once daily throughout the study duration. Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2 (on Days 1, 8, and 15 of each cycle).
451026|NCT00486954|E2|Reported Event|Lapatinib Plus Paclitaxel in Gastrectomy Participants|In the Pilot part, participants with gastrectomy (pylorus removed) received 1500 mg of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg/m^2.
451027|NCT00486954|E1|Reported Event|Lapatinib Plus Paclitaxel in Non-gastrectomy Participants|In the Pilot part, participants with non-gastrectomy (intact stomach) received 1500 milligrams (mg) of oral lapatinib once daily throughout the study duration (lapatinib was not administered on Day 1 of the first cycle). Participants received a paclitaxel 1-hour intravenous infusion weekly for 3 weeks of a 4-week cycle at 80 mg per square meters (m^2).
451028|NCT00486902|B3|Baseline|Total|Total of all reporting groups
451029|NCT00486902|B2|Baseline|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451030|NCT00486902|B1|Baseline|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451031|NCT00486902|P2|Participant Flow|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451032|NCT00486902|P1|Participant Flow|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451033|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451034|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451035|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451036|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451037|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451038|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451039|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451040|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451041|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451042|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451043|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451044|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451045|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451046|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451047|NCT00486902|O2|Outcome|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451048|NCT00486902|O1|Outcome|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451049|NCT00486902|E2|Reported Event|Placebo|Subjects receive IV Saline 20 mL 5 minutes after infant delivery
451050|NCT00486902|E1|Reported Event|Ketamine|Subjects receive IV ketamine 10 mg 5 minutes after infant delivery.
451051|NCT00486863|B3|Baseline|Total|Total of all reporting groups
451052|NCT00486863|B2|Baseline|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451054|NCT00486863|P2|Participant Flow|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours. The agent was gel encapsulated to reduce appreciation of odor and taste and mimic appearance of the placebo.
451055|NCT00486863|P1|Participant Flow|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules as the test agent, but with the inert compound dextrose.
451056|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451057|NCT00486863|O1|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451058|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451059|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451060|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451061|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451062|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451063|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451064|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451065|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451066|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451067|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451068|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451069|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451070|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451071|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451072|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451073|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451074|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451075|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451076|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451077|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451078|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451079|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451080|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451081|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451082|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451083|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451084|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451085|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451086|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451087|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451088|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451089|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451090|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451091|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451092|NCT00486863|O2|Outcome|Praziquantel at 12-16 Weeks Gestation|Praziquantel was administered orally as 60 mg/kg given in a split dose (30/mg/kg each) separated by 3 hours.
451093|NCT00486863|O1|Outcome|Placebo Control at 12-16 Weeks Gestation|Placebo was made with the same color-coded gelatin capsules with the inert compound dextrose.
451099|NCT00486837|P2|Participant Flow|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
451100|NCT00486837|P1|Participant Flow|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
451101|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451102|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451103|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451104|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451105|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451106|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451107|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451108|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451109|NCT00486837|O2|Outcome|Group 2|"Peripheral Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451110|NCT00486837|O1|Outcome|Group 1|"Bronchial Deposition~Alpha1-Proteinase Inhibitor (Human): 25 mg of Alpha1-Proteinase Inhibitor (Human) in the lungs, one inhalation per day over 4 weeks."
451111|NCT00486837|O2|Outcome|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
451112|NCT00486837|O1|Outcome|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
451113|NCT00486837|E2|Reported Event|Bronchial Deposition|Bronchial Deposition consists of inhalation of smaller volumes per breath at higher flow rates
451114|NCT00486837|E1|Reported Event|Peripheral Deposition|Peripheral Deposition is achieved with a breathing maneuver consisting of slow and deep breaths
451115|NCT00486811|B4|Baseline|Total|Total of all reporting groups
451116|NCT00486811|B3|Baseline|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451117|NCT00486811|B2|Baseline|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451118|NCT00486811|B1|Baseline|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451119|NCT00486811|P3|Participant Flow|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451120|NCT00486811|P2|Participant Flow|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily) The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451121|NCT00486811|P1|Participant Flow|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451122|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451123|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451217|NCT00486330|B1|Baseline|Tipranavir/Ritonavir (500mg/200mg)|
451124|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451125|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451126|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451127|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451128|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451129|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451130|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451131|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451132|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451133|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451134|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451135|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451136|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451137|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451171|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451138|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451139|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451140|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451141|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451142|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451143|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451144|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451145|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451146|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451147|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451148|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451149|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451150|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451151|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451172|NCT00486759|E2|Reported Event|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451152|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451153|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451154|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451155|NCT00486811|O3|Outcome|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451156|NCT00486811|O2|Outcome|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451157|NCT00486811|O1|Outcome|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451158|NCT00486811|E3|Reported Event|Oxycodone CR|"Oxycodone CR (20 to 50 mg twice daily).~The starting dose was oxycodone CR 10 mg twice daily for 3 days. The dose was then increased to 20 mg oxycodone CR twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions. Oxycodone doses were thus 10, 20, 30, 40 or 50 mg twice a day (BID) were dosed by participants during 15 weeks (3 weeks titration and 12 weeks maintenance)."
451159|NCT00486811|E2|Reported Event|Tapentadol ER|"Tapentadol ER (100 to 250 mg twice daily)~The starting dose was tapentadol ER 50 mg twice daily for 3 days. The dose was then increased to 100 mg tapentadol ER twice daily for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days. Dose decreases were allowed without time restrictions.~Tapentadol ER 50, 100, 150, 200 or 250 mg twice a day (BID) during 15 weeks were dosed by participants (3 weeks titration and 12 weeks maintenance)."
451160|NCT00486811|E1|Reported Event|Placebo Matching|"Drug: Matching Placebo (twice daily)~The starting dose of placebo was matched with the active treatment arms taken twice daily for the first 3 days. The dose was then increased to match the active treatments for at least 4 days. Thereafter, during the titration and maintenance phase participants were allowed to increase the dose every 3 days as in the active treatment arms. Dose decreases were allowed without time restrictions."
451161|NCT00486759|B3|Baseline|Total|Total of all reporting groups
451162|NCT00486759|B2|Baseline|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451163|NCT00486759|B1|Baseline|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451164|NCT00486759|P2|Participant Flow|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451165|NCT00486759|P1|Participant Flow|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451166|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451167|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451168|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451169|NCT00486759|O1|Outcome|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451170|NCT00486759|O2|Outcome|Placebo + Rituximab + CHOP|Patients received placebo to bevacizumab on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
453849|NCT00477269|O2|Outcome|Placebo|Placebo
451173|NCT00486759|E1|Reported Event|Bevacizumab + Rituximab + CHOP|Patients received bevacizumab 5 mg/kg/week on Day 1 of each cycle + rituximab 375 mg/m^2 intravenously (IV) on Day 1 of each cycle + CHOP (cyclophosphamide, hydroxydaunorubicin [doxorubicin], Oncovin [vincristine], prednisone).
451174|NCT00486720|B3|Baseline|Total|Total of all reporting groups
451175|NCT00486720|B2|Baseline|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
451176|NCT00486720|B1|Baseline|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
451177|NCT00486720|P2|Participant Flow|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
451178|NCT00486720|P1|Participant Flow|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
451179|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
451180|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
451181|NCT00486720|O2|Outcome|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
451182|NCT00486720|O1|Outcome|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
451183|NCT00486720|E2|Reported Event|Vorinostat Thrice Daily Dose Schedule|Vorinostat 200 mg three times daily for 14 consecutive days in a 21 day cycle.
451184|NCT00486720|E1|Reported Event|Vorinostat Once Daily Dose Schedule|Vorinostat 400 mg once daily for 14 consecutive days in a 21 day cycle.
451185|NCT00486525|B3|Baseline|Total|Total of all reporting groups
451186|NCT00486525|B2|Baseline|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451187|NCT00486525|B1|Baseline|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451188|NCT00486525|P2|Participant Flow|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451189|NCT00486525|P1|Participant Flow|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451190|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451191|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451192|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451193|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451194|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451195|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451196|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451197|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451198|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451199|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451200|NCT00486525|O2|Outcome|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451201|NCT00486525|O1|Outcome|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451202|NCT00486525|E2|Reported Event|Arm II: Wait-List|Wait-listed women were told to continue performing their usual activities, and to refrain from beginning any yoga practice. After their final assessment they were offered the yoga classes.
451203|NCT00486525|E1|Reported Event|Arm I: Yoga Therapy|Patients participated in a Hatha yoga session over 90 minutes twice weekly for 12 weeks. Patients were also encouraged to practice yoga at home. Patients recorded their total home/class practice time in weekly logs.
451204|NCT00486434|B3|Baseline|Total|Total of all reporting groups
451205|NCT00486434|B2|Baseline|Placebo Arm|1 SMC021 Placebo tablet twice daily
451206|NCT00486434|B1|Baseline|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
451207|NCT00486434|P2|Participant Flow|Placebo Arm|1 SMC021 Placebo tablet twice daily
451208|NCT00486434|P1|Participant Flow|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
451209|NCT00486434|O2|Outcome|Placebo Arm|1 SMC021 Placebo tablet twice daily
451210|NCT00486434|O1|Outcome|Active Arm|0.8mg SMC021 Oral Calcitonin tablet twice daily
451218|NCT00486330|P1|Participant Flow|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg (TPV/r) was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
451219|NCT00486330|O1|Outcome|Tipranavir/Ritonavir (500mg/200mg)|Subjects on buprenorphine maintenance therapy prior to starting the study. Subsequently, tipranavir 500 mg and ritonavir 200 mg was administered twice daily for a minimum of 7 days. Subjects served as their own controls. PK parameters were evaluated Pre- and Post-administration of tipranavir.
451220|NCT00486330|E1|Reported Event|Tipranavir/Ritonavir (500mg/200mg)|
451221|NCT00486291|B3|Baseline|Total|Total of all reporting groups
451222|NCT00486291|B2|Baseline|Placebo|Matched placebo
451223|NCT00486291|B1|Baseline|Active|Phentermine 15mg/topiramate 100mg
451224|NCT00486291|P2|Participant Flow|Placebo|Matched placebo
451225|NCT00486291|P1|Participant Flow|Active|Phentermine 15mg/topiramate 100mg
451226|NCT00486291|O2|Outcome|Placebo|Matched placebo
451227|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
451228|NCT00486291|O2|Outcome|Placebo|Matched placebo
451229|NCT00486291|O1|Outcome|Active|Phentermine 15mg and topiramate 100mg
451230|NCT00486291|E2|Reported Event|Placebo|Matched placebo
451231|NCT00486291|E1|Reported Event|Active|Phentermine 15mg/topiramate 100mg
451232|NCT00486278|B1|Baseline|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
451233|NCT00486278|P1|Participant Flow|All Subjects|A total of 51 subjects with 96 qualifying bleeds were treated in the study. A subject could contribute with up to one qualifying bleeding episode per study arm.
451234|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451235|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451236|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451237|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451238|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451239|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451240|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451241|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451242|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451243|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451244|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451245|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451246|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451247|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451248|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451249|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451250|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451251|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451252|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451253|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451254|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451255|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451256|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451257|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451258|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451259|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451260|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451261|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451262|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451263|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451264|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451265|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451266|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451267|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451268|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451269|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451270|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451271|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451272|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451273|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451274|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451490|NCT00485758|E2|Reported Event|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451275|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451276|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451277|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451278|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451279|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451280|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451281|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451282|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451283|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451284|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451285|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451286|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451287|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451288|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451289|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451290|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451291|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451292|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451293|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451294|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451295|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451296|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451297|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451298|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451541|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451542|NCT00485472|O2|Outcome|Placebo|Placebo
451299|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451300|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451301|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451302|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451303|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451304|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451305|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451306|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451307|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451308|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451309|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451310|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451311|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451312|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451313|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451314|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451315|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451316|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451317|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451318|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451319|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451320|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451321|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451322|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451543|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451544|NCT00485472|O2|Outcome|Placebo|Placebo
451323|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451324|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451325|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451326|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451327|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451328|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451329|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451330|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451331|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451332|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451333|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451334|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451335|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451336|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451337|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451338|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451339|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451340|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451341|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451342|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451343|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451344|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451345|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451346|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451545|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451546|NCT00485472|O2|Outcome|Placebo|Placebo
451347|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451348|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451349|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451350|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451351|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451352|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451353|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451354|NCT00486278|O6|Outcome|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451355|NCT00486278|O5|Outcome|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451356|NCT00486278|O4|Outcome|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451357|NCT00486278|O3|Outcome|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451358|NCT00486278|O2|Outcome|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451359|NCT00486278|O1|Outcome|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451360|NCT00486278|E6|Reported Event|rFVIIa 90 mcg/kg|Subjects received rFVIIa standard dose regimen 90 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to 5 qualifying bleeding episode per to the rFVIIa arm, corresponding to number of dose escalation cohorts.
451361|NCT00486278|E5|Reported Event|Vatreptacog Alfa 80 mcg/kg|Subjects received vatreptacog alfa 80 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451362|NCT00486278|E4|Reported Event|Vatreptacog Alfa 40 mcg/kg|Subjects received vatreptacog alfa 40 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451363|NCT00486278|E3|Reported Event|Vatreptacog Alfa 20 mcg/kg|Subjects received vatreptacog alfa 20 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451364|NCT00486278|E2|Reported Event|Vatreptacog Alfa 10 mcg/kg|Subjects received vatreptacog alfa 10 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451365|NCT00486278|E1|Reported Event|Vatreptacog Alfa 5 mcg/kg|Subjects received vatreptacog alfa 5 mcg/kg intravenously every 3 hours (+ 30 minutes) maximum of 3 times until bleeding was controlled. A subject could contribute with up to one qualifying bleeding episode per vatreptacog alfa arm.
451366|NCT00486265|B1|Baseline|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
451367|NCT00486265|P1|Participant Flow|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
451368|NCT00486265|O1|Outcome|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
451369|NCT00486265|E1|Reported Event|AZD4877|AZD4877 [ Time Frame: administered on days 1,2 and 3]
451370|NCT00486252|B1|Baseline|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451371|NCT00486252|P1|Participant Flow|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451372|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451373|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451374|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451375|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451376|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451377|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451378|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451379|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451380|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451381|NCT00486252|O3|Outcome|Latanaprost (Prior Beta-blocker Failure)|Subjects previously receiving beta-blocker: Subjects who previously failed beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451382|NCT00486252|O2|Outcome|Latanoprost (no Prior Beta-blocker Therapy)|Naive Subject: Subjects with no prior beta-blocker therapy were administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451383|NCT00486252|O1|Outcome|Latanoprost (All Subjects)|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451384|NCT00486252|E1|Reported Event|Latanoprost All Subjects|Subjects administered 1 drop of latanoprost (0.005%, 50 μg/mL) eye drops solution daily as prescribed by the investigator.
451385|NCT00486226|B1|Baseline|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device and were consented before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451386|NCT00486226|P1|Participant Flow|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device (VRD).~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451387|NCT00486226|O2|Outcome|Endovascular - Occlusion Results at 6 Months Follow-up|Aneurysm occlusion assessed at 6 months follow-up using the Raymond Scale.
451388|NCT00486226|O1|Outcome|Endovascular - Occlusion Results Immediately Post-procedure|Aneurysm occlusion was assessed immediately post procedure using the Raymond Scale.
451389|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451390|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451391|NCT00486226|O1|Outcome|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451392|NCT00486226|E1|Reported Event|1 Endovascular|"All patients implanted with an CORDIS ENTERPRISE Vascular Reconstruction Device who signed consent before the procedure.~Vascular Reconstruction Device: CORDIS ENTERPRISE™ VRD"
451393|NCT00486044|B3|Baseline|Total|Total of all reporting groups
451394|NCT00486044|B2|Baseline|Placebo|Matching placebo tablet nightly for 9 months
451395|NCT00486044|B1|Baseline|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451396|NCT00486044|P2|Participant Flow|Placebo|Matching placebo tablet nightly for 9 months
451397|NCT00486044|P1|Participant Flow|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451398|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
451399|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451400|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
451401|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451402|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
451403|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451404|NCT00486044|O2|Outcome|Placebo|Matching placebo tablet nightly for 9 months
451405|NCT00486044|O1|Outcome|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451406|NCT00486044|E2|Reported Event|Placebo|Matching placebo tablet nightly for 9 months
451407|NCT00486044|E1|Reported Event|Simvastatin|Simvastatin 40 mg tablet nightly for 1 month then 80 mg tablet nightly for 8 months
451408|NCT00486018|B4|Baseline|Total|Total of all reporting groups
451409|NCT00486018|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451410|NCT00486018|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451411|NCT00486018|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451412|NCT00486018|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451413|NCT00486018|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451414|NCT00486018|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451547|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451548|NCT00485472|O2|Outcome|Placebo|Placebo
451415|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451416|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451417|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451418|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451419|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451420|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451421|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451422|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451423|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451424|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451425|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451426|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451427|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451428|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451429|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451430|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451431|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451432|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451433|NCT00486018|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451434|NCT00486018|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451435|NCT00486018|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451436|NCT00486018|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451437|NCT00486018|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451438|NCT00486018|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451439|NCT00485953|B3|Baseline|Total|Total of all reporting groups
451440|NCT00485953|B2|Baseline|Placebo Group|Received placebo medication once per week
451441|NCT00485953|B1|Baseline|Active Medicine Group|risedronate 35 mg weekly
451442|NCT00485953|P2|Participant Flow|Placebo Group|Received placebo medication once per week
451443|NCT00485953|P1|Participant Flow|Active Medication Group|"risedronate 35 mg weekly~risedronate: risedronate 35 mg per week"
451444|NCT00485953|O2|Outcome|Placebo Group|Received placebo medication once weekly
451445|NCT00485953|O1|Outcome|Active Medicine Group|risedronate 35 mg weekly
451446|NCT00485953|E2|Reported Event|Placebo Group|Receive placebo medication once per week
451447|NCT00485953|E1|Reported Event|Active Medicine Group|risedronate 35 mg weekly
451448|NCT00485836|B4|Baseline|Total|Total of all reporting groups
451449|NCT00485836|B3|Baseline|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451450|NCT00485836|B2|Baseline|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451451|NCT00485836|B1|Baseline|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451452|NCT00485836|P3|Participant Flow|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451453|NCT00485836|P2|Participant Flow|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451454|NCT00485836|P1|Participant Flow|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451455|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451549|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451456|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451457|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451458|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451459|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451460|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451461|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451462|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451463|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451464|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451465|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451466|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451467|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451468|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451469|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451470|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451471|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451472|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451473|NCT00485836|O3|Outcome|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451474|NCT00485836|O2|Outcome|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451475|NCT00485836|O1|Outcome|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451476|NCT00485836|E3|Reported Event|Ranibizumab Injection 0.5 mg|Ranibizumab injection 0.5 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451477|NCT00485836|E2|Reported Event|Ranibizumab Injection 0.3 mg|Ranibizumab injection 0.3 mg in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six injections.
451478|NCT00485836|E1|Reported Event|Sham Injection|Sham injection in a single-dose regimen given every month (Day 0 through the Month 5 visit), for a total of six sham injections.
451479|NCT00485758|B3|Baseline|Total|Total of all reporting groups
451480|NCT00485758|B2|Baseline|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451481|NCT00485758|B1|Baseline|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451482|NCT00485758|P2|Participant Flow|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451483|NCT00485758|P1|Participant Flow|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451484|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451485|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451486|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451487|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451488|NCT00485758|O2|Outcome|Placebo|Matching placebo added to lipid modifying regimen and continued on this regimen for remainder of the study.
451489|NCT00485758|O1|Outcome|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451550|NCT00485472|O2|Outcome|Placebo|Placebo
451491|NCT00485758|E1|Reported Event|Extended Release Niacin/Laropiprant|"One tablet of Extended Release Niacin/Laropiprant (1 gram/20 milligram) in addition to lipid modifying therapy. After 4 weeks, advanced to Extended Release Niacin/Laropiprant (2 gram/40 milligram).~No adjustments were made to any lipid modifying regimen established during run-in until Week 12."
451492|NCT00485732|B3|Baseline|Total|Total of all reporting groups
451493|NCT00485732|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451494|NCT00485732|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451495|NCT00485732|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451496|NCT00485732|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451497|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451498|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451499|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451500|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451501|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451502|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451503|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451504|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451505|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451506|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451507|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451508|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451509|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451510|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451511|NCT00485732|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451512|NCT00485732|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451513|NCT00485732|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo according to a 0, 1, 6-month schedule.
451514|NCT00485732|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 VLP/AS04 vaccine (Cervarix TM) vaccine administered intramuscularly according to a 0, 1, 6-month schedule.
451515|NCT00485693|B3|Baseline|Total|Total of all reporting groups
451516|NCT00485693|B2|Baseline|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
451517|NCT00485693|B1|Baseline|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
451518|NCT00485693|P2|Participant Flow|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
451519|NCT00485693|P1|Participant Flow|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
451520|NCT00485693|O5|Outcome|SKY0402 High Dose|Single administration of study drug in a volume of 60 mL via local infiltration
451521|NCT00485693|O4|Outcome|SKY0402 High-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
451522|NCT00485693|O3|Outcome|SKY0402 Low-mid Dose|Single administration of study drug in a volume of 60 mL via local infiltration
451523|NCT00485693|O2|Outcome|SKY0402 Low Dose|Single administration of study drug in a volume of 60 mL via local infiltration
451524|NCT00485693|O1|Outcome|Bupivacaine HCl|Single administration of 150 mg bupivacaine HCl in a 60-mL injection volume (undiluted)
451525|NCT00485693|E2|Reported Event|SKY0402|A single dose of study drug was to be administered intraoperatively via local infiltration
451526|NCT00485693|E1|Reported Event|Bupivacaine HCl|A single dose of study drug was to be administered intraoperatively via local infiltration
451527|NCT00485485|B1|Baseline|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
451528|NCT00485485|P1|Participant Flow|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
451529|NCT00485485|O1|Outcome|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
451530|NCT00485485|E1|Reported Event|Imatinib Mesylate + Docetaxel|Imatinib 400 mg orally daily; Docetaxel 60 mg/m^2 by vein over 1 hour every 3 weeks
451531|NCT00485472|B3|Baseline|Total|Total of all reporting groups
451532|NCT00485472|B2|Baseline|Placebo|Placebo
451533|NCT00485472|B1|Baseline|Lacosamide|Lacosamide (LCM) 400 mg/day
451534|NCT00485472|P2|Participant Flow|Placebo|Placebo
451535|NCT00485472|P1|Participant Flow|Lacosamide|Lacosamide (LCM) 400 mg/day
451536|NCT00485472|O2|Outcome|Placebo|Placebo
451537|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451538|NCT00485472|O2|Outcome|Placebo|Placebo
451539|NCT00485472|O1|Outcome|Lacosamide|Lacosamide (LCM) 400 mg/day
451540|NCT00485472|O2|Outcome|Placebo|Placebo
451555|NCT00485472|E1|Reported Event|Lacosamide|Lacosamide (LCM) 400 mg/day
451556|NCT00485433|B5|Baseline|Total|Total of all reporting groups
451557|NCT00485433|B4|Baseline|SKY0402 High Dose|SKY0402 high dose given during hernia repair
451558|NCT00485433|B3|Baseline|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
451559|NCT00485433|B2|Baseline|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
451560|NCT00485433|B1|Baseline|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
451561|NCT00485433|P4|Participant Flow|SKY0402 High Dose|SKY0402 high dose given during hernia repair
451562|NCT00485433|P3|Participant Flow|SKY0402 Middle Dose|SKY0402 middle dose given during hernia repair
451563|NCT00485433|P2|Participant Flow|SKY0402 Low Dose|SKY0402 low dose given during hernia repair
451564|NCT00485433|P1|Participant Flow|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
451565|NCT00485433|O4|Outcome|SKY0402 High Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
451566|NCT00485433|O3|Outcome|SKY0402 Middle Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
451567|NCT00485433|O2|Outcome|SKY0402 Low Dose|A single dose of SKY0402 diluted to a 42-mL injection volume administered via local infiltration during surgery
451568|NCT00485433|O1|Outcome|Bupivacaine HCl 105mg|A single dose of 105 mg bupivacaine in a 42-mL injection volume administered via local infiltration during surgery
451569|NCT00485433|E2|Reported Event|SKY0402 (All Doses)|SKY0402 given during hernia repair
451570|NCT00485433|E1|Reported Event|Bupivacaine HCl 105mg|Bupivacaine HCl given during hernia repair
451571|NCT00485303|B1|Baseline|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451572|NCT00485303|P1|Participant Flow|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451573|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451574|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451575|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451576|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451577|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451578|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451579|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451580|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451581|NCT00485303|O1|Outcome|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451582|NCT00485303|E1|Reported Event|Abiraterone|Abiraterone acetate 1000 milligram (mg) (4 oral tablets of 250 mg each) was administered once daily along with 5 mg oral prednisolone or prednisone tablet administered twice daily for 28-days dosing cycle and was continued until disease progression or unacceptable toxicity.
451583|NCT00485264|B7|Baseline|Total|Total of all reporting groups
451584|NCT00485264|B6|Baseline|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451585|NCT00485264|B5|Baseline|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451586|NCT00485264|B4|Baseline|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451587|NCT00485264|B3|Baseline|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451588|NCT00485264|B2|Baseline|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451589|NCT00485264|B1|Baseline|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451590|NCT00485264|P6|Participant Flow|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451591|NCT00485264|P5|Participant Flow|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451592|NCT00485264|P4|Participant Flow|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451593|NCT00485264|P3|Participant Flow|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451594|NCT00485264|P2|Participant Flow|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451595|NCT00485264|P1|Participant Flow|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451596|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451597|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451598|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451599|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451600|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451601|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451602|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451603|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451604|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451605|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451606|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451607|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451608|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451609|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451610|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451611|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451612|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451613|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451614|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451641|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451615|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451616|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451617|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451618|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451619|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451620|NCT00485264|O6|Outcome|Cohort V -Data Not Included in This Interim Analysis.|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451621|NCT00485264|O5|Outcome|Cohort IV -Data Not Included in This Interim Analysis.|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451622|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451623|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451624|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451625|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451626|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451627|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451628|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451629|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451630|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451631|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451632|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451633|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451634|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451635|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451636|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451637|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451638|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451639|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451640|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
452059|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
451642|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451643|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451644|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451645|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451646|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451647|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451648|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451649|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451650|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451651|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451652|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451653|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451654|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451655|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451656|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451657|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451658|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451659|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451660|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451661|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451662|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451663|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451664|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451665|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451666|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451667|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451668|NCT00485264|O6|Outcome|Cohort V|Participants between the ages of 4 weeks and 5 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
453850|NCT00477269|O1|Outcome|STI571|STI571
451669|NCT00485264|O5|Outcome|Cohort IV|Participants between the ages of 6 and 23 months; receiving raltegravir oral granules for suspension (20 mg/mL): Stage I starting dose of 6 mg/kg orally twice daily according to dosing table in protocol or the dose determined by review of all available data. Not included in this interim analysis.
451670|NCT00485264|O4|Outcome|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451671|NCT00485264|O3|Outcome|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451672|NCT00485264|O2|Outcome|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451673|NCT00485264|O1|Outcome|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451674|NCT00485264|E4|Reported Event|Cohort III|Participants between the ages of 2 and 5 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451675|NCT00485264|E3|Reported Event|Cohort IIB|Participants between the ages of 6 and 11 years; receiving raltegravir chewable tablet: final selected dose: Weight based dose of ~6 mg/kg to a maximum dose of 300 mg, taken orally twice daily.
451676|NCT00485264|E2|Reported Event|Cohort IIA|Participants between the ages of 6 and 11 years; receiving raltegravir poloxamer film coated tablet: final selected dose: 400-mg tablet taken orally twice daily for participants weighing at least 25 kg.
451677|NCT00485264|E1|Reported Event|Cohort I|Participants between the ages of 12 and 18 years; receiving raltegravir poloxamer film coated tablet; final selected dose: 400-mg tablet taken orally twice daily.
451678|NCT00485173|B3|Baseline|Total|Total of all reporting groups
451679|NCT00485173|B2|Baseline|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451680|NCT00485173|B1|Baseline|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451681|NCT00485173|P2|Participant Flow|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451682|NCT00485173|P1|Participant Flow|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451683|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451684|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451685|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451686|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451687|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451688|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451689|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451690|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451691|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451692|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451693|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451694|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451695|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451696|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451697|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451698|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
452362|NCT00483262|O1|Outcome|CCI779 Response Phase I|Response of PR or better per the Blade criteria in phase I part of this phase I/II study of CCI779 and velcade
451699|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451700|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451701|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451702|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451703|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451704|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451705|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451706|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451707|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451708|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451709|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451710|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451711|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451712|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451713|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451714|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451715|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451716|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451717|NCT00485173|O2|Outcome|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451718|NCT00485173|O1|Outcome|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451719|NCT00485173|E2|Reported Event|Historical Control|Historical control was pooled from the control arms of the following Medtronic studies: (1) the Artificial Cervical Disc (also known as PRESTIGE® Cervical Disc System) pivotal IDE trial (NCT00642876) and (2) the BRYAN® Cervical Disc System pivotal IDE trial (NCT00437190).
451720|NCT00485173|E1|Reported Event|INFUSE® Bone Graft|In this arm, patients received implant with INFUSE® Bone Graft/PEEK Spacer/Anterior Cervical Plate.
451721|NCT00485069|B3|Baseline|Total|Total of all reporting groups
451722|NCT00485069|B2|Baseline|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451723|NCT00485069|B1|Baseline|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451724|NCT00485069|P2|Participant Flow|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
452060|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
451725|NCT00485069|P1|Participant Flow|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day and was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals of at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451726|NCT00485069|O2|Outcome|"ROP+L-Dopa, On Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451727|NCT00485069|O1|Outcome|"ROP+L-Dopa, Off Hours"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451728|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451729|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451730|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451731|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451732|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451733|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451734|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451735|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451736|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451790|NCT00484679|B1|Baseline|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
452239|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
451737|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451738|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451739|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451740|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451741|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451742|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451743|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451744|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451745|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451746|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451747|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451748|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451749|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
453509|NCT00479336|E2|Reported Event|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
451750|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off Sate (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451751|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451752|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451753|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451754|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451755|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451756|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451757|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451758|NCT00485069|O1|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451759|NCT00485069|O2|Outcome|"ROP+L-Dopa, Off State (Only Participants With Off State)"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451760|NCT00485069|O1|Outcome|"ROP+L-Dopa, On State"|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451761|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451762|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451763|NCT00485069|O2|Outcome|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451764|NCT00485069|O1|Outcome|ROP+L-Dopa|Participants received ropinirole hydrochloride (ROP) tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 milligrams (mg)/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451765|NCT00485069|E2|Reported Event|Ropinirole Hydrochloride|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. Concomitant use of L-dopa was prohibited during the study.
451766|NCT00485069|E1|Reported Event|ROP+L-Dopa|Participants received ROP tablets 3 times daily. In the 4-week Fixed Titration Phase (from Week 0 as Baseline), the dose started at 0.75 mg/day was increased weekly by 0.75 mg/day up to 3.0 mg/day. In the 48-week Flexible Titration and Maintenance Phase, the dose was increased by 1.5 mg/day at intervals at least 1 week up to a maximum of 15.0 mg/day. The dose was maintained at a level without further symptomatic improvement expected. The dosing regimen of L-dopa remained unchanged from 4 weeks prior to the start of the Screening Phase throughout the study.
451767|NCT00484939|B3|Baseline|Total|Total of all reporting groups
451768|NCT00484939|B2|Baseline|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451769|NCT00484939|B1|Baseline|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451770|NCT00484939|P2|Participant Flow|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451771|NCT00484939|P1|Participant Flow|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451772|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451773|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451774|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451775|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451776|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451777|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451778|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451779|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451780|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451781|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451782|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451783|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451784|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451785|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451786|NCT00484939|O2|Outcome|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451787|NCT00484939|O1|Outcome|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451788|NCT00484939|E2|Reported Event|Capecitabine|Participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
451789|NCT00484939|E1|Reported Event|Bevacizumab + Capecitabine|Participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3-week treatment cycle. In addition, participants received capecitabine 1000 mg/m^2 orally twice daily on Days 1-14 of each 3-week treatment cycle.
453510|NCT00479336|E1|Reported Event|Placebo|Placebo, 1 tablet a day
451791|NCT00484679|P1|Participant Flow|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
451792|NCT00484679|O1|Outcome|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
451793|NCT00484679|E1|Reported Event|(Kenalog-10) Intralesional Injections for Alopecia Areata|Patients received Triamcinolone Acetonide 10 ml (Kenalog-10) intralesional injections every 6 weeks for 6 months. Disease extent and efficacy was assessed along with safety studies involving regularly scheduled ACTH stimulation tests.
451794|NCT00484419|B4|Baseline|Total|Total of all reporting groups
451795|NCT00484419|B3|Baseline|Sitagliptin|sitagliptin phosphate tablets 100mg
451796|NCT00484419|B2|Baseline|Rosiglitazone|rosiglitazone maleate 4mg
451797|NCT00484419|B1|Baseline|Colesevelam|colesevelam tablets 625 mg
451798|NCT00484419|P3|Participant Flow|Sitagliptin|sitagliptin phosphate tablets 100mg
451799|NCT00484419|P2|Participant Flow|Rosiglitazone|rosiglitazone maleate 4mg
451800|NCT00484419|P1|Participant Flow|Colesevelam|colesevelam tablets 625 mg
451801|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451802|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451803|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451804|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451805|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451806|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451807|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451808|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451809|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451810|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451811|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451812|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451813|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451814|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451815|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451816|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451817|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451818|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451819|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451820|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451821|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451822|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451823|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451824|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451825|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451826|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451827|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451828|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451829|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451830|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451831|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451832|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451833|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451834|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451835|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451836|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451837|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451838|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451839|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451840|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451841|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451842|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451843|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451844|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451845|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451846|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451847|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451848|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451849|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451850|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451851|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451852|NCT00484419|O3|Outcome|Sitagliptin|sitagliptin phosphate tablets 100mg
451853|NCT00484419|O2|Outcome|Rosiglitazone|rosiglitazone maleate 4mg
451854|NCT00484419|O1|Outcome|Colesevelam|colesevelam tablets 625 mg
451855|NCT00484393|B3|Baseline|Total|Total of all reporting groups
451856|NCT00484393|B2|Baseline|Placebo First|Placebo cream (Aquatain) 1g applied to inejction site first, then tetracaine with subsequent injection
451857|NCT00484393|B1|Baseline|Tetracaine First|Tetracaine 4% gel 1g applied to injection site first, then placebo with subsequent injection
451858|NCT00484393|P2|Participant Flow|Placebo Then Tetracaine|Placebo cream (Aquatain) 1g applied to inejction site prior to next palivizumab injection after enrollment Tetracaine 4% gel 1g applied to injection site prior to subsequent palivizumab injection (1 month after 1st study injection)
451859|NCT00484393|P1|Participant Flow|Tetracaine Then Placebo|Tetracaine 4% gel 1g applied to injection site prior to next palivizumab injection after enrollment Placebo cream (Aquatain) 1g applied to inejction site prior to subsequent palivizumab injection (1 month after 1st study injection)
451860|NCT00484393|O2|Outcome|Placebo|Placebo cream (Aquatain) 1g applied to inejction site
451861|NCT00484393|O1|Outcome|Tetracaine|Tetracaine 4% gel 1g applied to injection site
451862|NCT00484393|E2|Reported Event|Placebo|"Placebo cream (Aquatain) 1g applied to inejction site~Placebo: placebo applied prior to 1 injection"
451863|NCT00484393|E1|Reported Event|Tetracaine|"Tetracaine 4% gel 1g applied to injection site~tetracaine 4% gel: tetracaine applied prior to 1 injection"
451864|NCT00484315|B3|Baseline|Total|Total of all reporting groups
451865|NCT00484315|B2|Baseline|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
451866|NCT00484315|B1|Baseline|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
451867|NCT00484315|P2|Participant Flow|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
451868|NCT00484315|P1|Participant Flow|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
451869|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
451870|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
451871|NCT00484315|O2|Outcome|TAXUS Express|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
451872|NCT00484315|O1|Outcome|TAXUS Element|Paclitaxel-eluting stent (PES) implanted using standard percutaneous coronary intervention (PCI) technique
451873|NCT00484315|E2|Reported Event|TAXUS Express|Participants randomized to treatment with TAXUS Express paclitaxel-eluting stent (control device)
451874|NCT00484315|E1|Reported Event|TAXUS Element|Participants randomized to treatment with TAXUS Element paclitaxel-eluting stent (investigational device)
451875|NCT00484289|B4|Baseline|Total|Total of all reporting groups
451876|NCT00484289|B3|Baseline|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451877|NCT00484289|B2|Baseline|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451878|NCT00484289|B1|Baseline|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451879|NCT00484289|P3|Participant Flow|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451880|NCT00484289|P2|Participant Flow|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451881|NCT00484289|P1|Participant Flow|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451882|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451883|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451884|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451885|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451886|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451961|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451887|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451888|NCT00484289|O1|Outcome|All Participants From IM101-129 Study|Participants with rheumatoid arthritis (RA) who participated in studies IM101-034 and IM101-071. Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Weeks 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451889|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451890|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451891|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451892|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451893|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451894|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451895|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451896|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451897|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451898|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451899|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451900|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451901|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451902|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451903|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451904|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451905|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451906|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451907|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451908|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451909|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451910|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451911|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451912|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451913|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451914|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451915|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451916|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451917|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451918|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451919|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451920|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451921|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451922|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451923|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451924|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451925|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451926|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451927|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451928|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451929|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451930|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451931|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451932|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451933|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451934|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451935|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451936|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451937|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451938|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451939|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451940|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451941|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451942|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451943|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451944|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451945|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451946|NCT00484289|O3|Outcome|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451947|NCT00484289|O2|Outcome|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451948|NCT00484289|O1|Outcome|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451949|NCT00484289|E3|Reported Event|New Participants With MTX Intolerance; Abatacept 10 mg/kg|Participants with RA in whom methotrexate (MTX) could not be administered for safety reasons and who presented an inadequate response to disease-modifying antirheumatic drugs (DMARDs [excluding MTX]) and biologics. Weight-tiered dose of abatacept (equivalent to 10 mg/kg), based on their body weight at the enrollment visit, was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451950|NCT00484289|E2|Reported Event|Participants From Phase II Study(IM101-071); Abatacept 10mg/kg|Participants with RA who participated in the phase II study (IM101-071). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an IV infusion.
451951|NCT00484289|E1|Reported Event|Participants From Phase I Study (IM101-034); Abatacept 10mg/kg|Participants with rheumatoid arthritis (RA) who participated in the phase I study (IM101-034). Weight-tiered dose of abatacept (equivalent to 10 mg/kg) based on their body weight at the enrollment visit was administered at Week 0, 2, 4 and every 4 weeks thereafter, as an intravenous (IV) infusion.
451952|NCT00484185|B1|Baseline|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451953|NCT00484185|P1|Participant Flow|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451954|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451955|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451956|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451957|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451958|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451959|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451960|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
453511|NCT00479258|B3|Baseline|Total|Total of all reporting groups
451962|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451963|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451964|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451965|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451966|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451967|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451968|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451969|NCT00484185|O1|Outcome|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451970|NCT00484185|E1|Reported Event|BeneFIX|Participants who received original or reformulated BeneFIX (recombinant coagulation factor IX) infusion intravenously as indicated according to the approved local product document, dosage solely adjusted as per physician’s discretion, were observed for a period of 6 months.
451971|NCT00484159|B4|Baseline|Total|Total of all reporting groups
451972|NCT00484159|B3|Baseline|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
451973|NCT00484159|B2|Baseline|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
451974|NCT00484159|B1|Baseline|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
451975|NCT00484159|P3|Participant Flow|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
451976|NCT00484159|P2|Participant Flow|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
451977|NCT00484159|P1|Participant Flow|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
451978|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
451979|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
451980|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
451981|NCT00484159|O3|Outcome|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
451982|NCT00484159|O2|Outcome|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
451983|NCT00484159|O1|Outcome|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
451984|NCT00484159|E3|Reported Event|Radiofrequency Group|Radiofrequency lumbar facet denervation without a diagnostic facet block.
451985|NCT00484159|E2|Reported Event|Single-block Group|Radiofrequency lumbar facet joint denervation if positive response to single facet joint block.
451986|NCT00484159|E1|Reported Event|Double-block Group|Radiofrequency lumbar facet joint denervation only if positive response to 2 diagnostic facet blocks.
451987|NCT00484094|B1|Baseline|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451988|NCT00484094|P1|Participant Flow|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451989|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451990|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451991|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451992|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451993|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
452240|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
451994|NCT00484094|O1|Outcome|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451995|NCT00484094|E1|Reported Event|Rapamune|Participants were administered Rapamune as part of routine practice. The use and dosage recommendations for Rapamune were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
451996|NCT00483938|B8|Baseline|Total|Total of all reporting groups
451997|NCT00483938|B7|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
451998|NCT00483938|B6|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
451999|NCT00483938|B5|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
452000|NCT00483938|B4|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452001|NCT00483938|B3|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
452002|NCT00483938|B2|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
452003|NCT00483938|B1|Baseline|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
452004|NCT00483938|P7|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452005|NCT00483938|P6|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452006|NCT00483938|P5|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
452007|NCT00483938|P4|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452008|NCT00483938|P3|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
452009|NCT00483938|P2|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
452010|NCT00483938|P1|Participant Flow|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
452011|NCT00483938|O6|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452012|NCT00483938|O5|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
452013|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452014|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
452015|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
452241|NCT00483652|O2|Outcome|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
452016|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
452017|NCT00483938|O4|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452018|NCT00483938|O3|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
452019|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452020|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
452021|NCT00483938|O2|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
452022|NCT00483938|O1|Outcome|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
452023|NCT00483938|E7|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group NR)|Participants who did not have any change in HCV-RNA levels at Weeks 4, 8, and 12 were not randomized (NR) to any of the other groups. Participants received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452024|NCT00483938|E6|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group F)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452025|NCT00483938|E5|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group E)|Participants with HCV-RNA levels <15 IU/mL at Week 4, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 24 weeks, and ribavirin 1000 to 1400 mg orally daily for 24 weeks.
452026|NCT00483938|E4|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group D)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 48 weeks, and ribavirin 1000 to 1400 mg orally daily for 48 weeks.
452027|NCT00483938|E3|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group C)|Participants with HCV-RNA levels >15 IU/mL at Week 4, and HCV-RNA <15 IU/mL at Week 8, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 36 weeks, and ribavirin 1000 to 1400 mg orally daily for 36 weeks.
452028|NCT00483938|E2|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group B)|Participants with HCV RNA levels >15 IU/mL at Week 4, HCV RNA >=15 IU/mL at Week 8, and either HCV RNA <15 IU/mL or >=2 log10 drop at Week 12, received pegylated-interferon alfa-2a 180 mcg subcutaneously once in a week for 72 weeks, and ribavirin 1000 to 1400 mg orally daily for 72 weeks.
452029|NCT00483938|E1|Reported Event|Pegylated-interferon Alfa-2a + Ribavirin (Group A)|Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) levels greater than (>) 15 international units per milliliter (IU/mL) at Week 4, HCV RNA greater than or equal to (>=) 15 IU/mL at Week 8, and either HCV RNA less than (<) 15 IU/mL or >=2 times logarithmic (2 log10) drop at Week 12, received pegylated-interferon alfa-2a (Pegasys) 180 micrograms (mcg) subcutaneously once in a week for 48 weeks, and ribavirin (Copegus) 1000 to 1400 milligrams (mg) orally daily for 48 weeks.
452030|NCT00482729|B3|Baseline|Total|Total of all reporting groups
452031|NCT00482729|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452032|NCT00482729|B1|Baseline|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452033|NCT00482729|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452034|NCT00482729|P1|Participant Flow|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452035|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452036|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452037|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452038|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452039|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452040|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452041|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452042|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452043|NCT00482729|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452044|NCT00482729|O1|Outcome|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452045|NCT00482729|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with oral tablets of metformin initiated at a dose of 500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 1000 mg b.i.d. ; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452046|NCT00482729|E1|Reported Event|Sita/Met FDC|The Sitagliptin/Metformin Fixed Dose Combination (Sita/Met FDC) group includes data from patients randomized to receive treatment with oral tablets of Sita/Met initiated at a dose of 50/500 mg twice a day (b.i.d.) The dose was to have been up-titrated over 4 weeks to 50/1000 mg b.i.d.; however, patients could stay in the study on a minimum dose of Sita/Met 50/500 mg b.i.d. if a higher dose was not tolerated.
452047|NCT00482703|B3|Baseline|Total|Total of all reporting groups
452048|NCT00482703|B2|Baseline|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452049|NCT00482703|B1|Baseline|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452050|NCT00482703|P2|Participant Flow|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452051|NCT00482703|P1|Participant Flow|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452052|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452053|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452054|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452055|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452056|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452057|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452058|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452061|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452062|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452063|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452064|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452065|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452066|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452067|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452068|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452069|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452070|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452071|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452072|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452073|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452074|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452075|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452076|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452077|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452078|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452079|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452080|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452081|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452082|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452083|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452084|NCT00482703|O2|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452085|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting dose of Dasatinib (BMS-354825) 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452086|NCT00482703|O6|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452087|NCT00482703|O5|Outcome|Dasatinib 50 mg BID Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452088|NCT00482703|O4|Outcome|Dasatinib 50 mg BID Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 50 mg BID oral continuous daily dosing (CCD) for 24 weeks.
452089|NCT00482703|O3|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-intolerant|Imatinib-intolerant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452090|NCT00482703|O2|Outcome|Dasatinib 100 mg QD Starting Dose - Imatinib-resistant|Imatinib-resistant participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452091|NCT00482703|O1|Outcome|Dasatinib 100 mg QD Starting Dose Cohort|All participants treated with a starting Dasatinib (BMS-354825) dose of 100 mg QD oral continuous daily dosing (CCD) for 24 weeks.
452092|NCT00482703|E3|Reported Event|Total|
452093|NCT00482703|E2|Reported Event|Dasatinib 50 mg Twice-daily (BID) Starting Dose|Starting dose of 50 mg BID oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452242|NCT00483652|O1|Outcome|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
452094|NCT00482703|E1|Reported Event|Dasatinib 100 mg Once-daily (QD) Starting Dose|Starting dose of 100 mg QD oral continuous daily dosing of Dasatinib (BMS-354825) for 24 weeks. One dose escalation allowed for nonresponding participants; dose reduction mandated according to the observed toxicity.
452095|NCT00483756|B4|Baseline|Total|Total of all reporting groups
452096|NCT00483756|B3|Baseline|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452097|NCT00483756|B2|Baseline|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452098|NCT00483756|B1|Baseline|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452099|NCT00483756|P3|Participant Flow|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452100|NCT00483756|P2|Participant Flow|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452101|NCT00483756|P1|Participant Flow|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452102|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452103|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452104|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452105|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452106|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452107|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452108|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452109|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452110|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452111|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452112|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452113|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452114|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452115|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452243|NCT00483652|E2|Reported Event|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
452244|NCT00483652|E1|Reported Event|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
452116|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452117|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452118|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452119|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452120|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452121|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452122|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452123|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452124|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452125|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452126|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452127|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452128|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452129|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452130|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452131|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452132|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452133|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452134|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452135|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452136|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452245|NCT00483574|B3|Baseline|Total|Total of all reporting groups
452363|NCT00483262|O2|Outcome|CCI779 Toxicity Phase II|Toxicity of CCI779 and velcade in the phase II part of this phase I/II study. CTC criteria used
452137|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452138|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452139|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452140|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452141|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452142|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452143|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452144|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452145|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452146|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452147|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452148|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452149|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452150|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452151|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452152|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452153|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452154|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452155|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452156|NCT00483756|O3|Outcome|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452157|NCT00483756|O2|Outcome|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452320|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452158|NCT00483756|O1|Outcome|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452159|NCT00483756|E3|Reported Event|CP-690,550 15 mg for Months 1 to 3|CP-690,550 15 mg tablet orally twice daily for Month 1 to 3, then 10 mg tablet orally twice daily for Month 4 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452160|NCT00483756|E2|Reported Event|CP-690,550 15 mg for Months 1 to 6|CP-690,550 15 milligram (mg) tablet orally twice daily for Month 1 to 6, then 10 mg tablet orally twice daily for Month 7 to 12. Participants also received mycophenolate mofetil 1 gram tablet orally twice daily for 12 months.
452161|NCT00483756|E1|Reported Event|Cyclosporine|Cyclosporine (CsA) microemulsion at a starting dose of 8 to 10 milligram per kilogram per day (mg/kg/day) orally twice daily in 2 equal doses for 12 months. Dosages were adjusted according to trough whole blood level and standard institutional practice. Participants also received mycophenolate mofetil tablet 1 gram orally twice daily (up to 1.5 gram orally twice daily in Black participants) for 12 months.
452162|NCT00483717|B3|Baseline|Total|Total of all reporting groups
452163|NCT00483717|B2|Baseline|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452164|NCT00483717|B1|Baseline|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452165|NCT00483717|P2|Participant Flow|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452166|NCT00483717|P1|Participant Flow|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452167|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452168|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452169|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452170|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452171|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452172|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452173|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452174|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452175|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452176|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452177|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452178|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452179|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452180|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452181|NCT00483717|O2|Outcome|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452182|NCT00483717|O1|Outcome|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452183|NCT00483717|E2|Reported Event|Placebo|"Intranasal Placebo~Placebo : Intranasal (IN) placebo"
452184|NCT00483717|E1|Reported Event|Ketorolac Tromethamine|"Intranasal ketorolac tromethamine~Ketorolac tromethamine : 31.5 mg of ketorolac 2 x 100uL IN sprays (15% ketorolac tromethamine with 6% lidocaine hydrochloride)"
452185|NCT00483704|B4|Baseline|Total|Total of all reporting groups
452186|NCT00483704|B3|Baseline|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452187|NCT00483704|B2|Baseline|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452188|NCT00483704|B1|Baseline|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452189|NCT00483704|P3|Participant Flow|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452190|NCT00483704|P2|Participant Flow|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452422|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452191|NCT00483704|P1|Participant Flow|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452192|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452193|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452194|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452195|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452196|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452197|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452198|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452199|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452200|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452201|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452202|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452203|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452204|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
452205|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
452206|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
452207|NCT00483704|O3|Outcome|Placebo|Participants who received at least one dose of placebo.
452208|NCT00483704|O2|Outcome|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
452209|NCT00483704|O1|Outcome|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
452210|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452211|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452212|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452213|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452423|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452214|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452215|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452216|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452217|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452218|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452219|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452220|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452221|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452222|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452223|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452224|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452225|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452226|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452227|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452228|NCT00483704|O3|Outcome|Placebo|The placebo group is comprised of Control Group 1 and Control Group 2. Control Group 1 receives placebo across 3 migraine attacks (1st, 2nd, and 4th) and telcagepant 140 mg for the 3rd migraine attack. Control Group 2 receives placebo across 3 migraine attacks (1st, 2nd, and 3rd) and telcagepant 140 mg for the 4th migraine attack. For both groups for migraine attacks 2, 3, and 4, no study medication will be provided as an optional second dose.
452229|NCT00483704|O2|Outcome|Telcagepant 280 mg|Telcagepant 280 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 280 mg or placebo.
452230|NCT00483704|O1|Outcome|Telcagepant 140 mg|Telcagepant 140 mg, oral, across 4 migraine attacks. For migraine attack 1 only, if no headache relief is obtained after 2 hours post dose, or if the migraine recurs after 2 hours of the initial treatment, participants may receive an optional second dose of telcagepant 140 mg or placebo.
452231|NCT00483704|E3|Reported Event|Placebo|Participants who received at least one dose of placebo.
452232|NCT00483704|E2|Reported Event|Telcagepant 280 mg|Participants who received at least one dose of telcagepant 280 mg.
452233|NCT00483704|E1|Reported Event|Telcagepant 140 mg|Participants who received at least one dose of telcagepant 140 mg.
452234|NCT00483652|B3|Baseline|Total|Total of all reporting groups
452235|NCT00483652|B2|Baseline|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
452236|NCT00483652|B1|Baseline|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
452237|NCT00483652|P2|Participant Flow|Placebo Treatment|Placebo b.i.d. dosing for 9 weeks
452238|NCT00483652|P1|Participant Flow|Fampridine-SR 10 mg b.i.d. Treatment|Fampridine-SR 10 mg b.i.d. dosing for 9 weeks
452246|NCT00483574|B2|Baseline|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452247|NCT00483574|B1|Baseline|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452248|NCT00483574|P2|Participant Flow|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452249|NCT00483574|P1|Participant Flow|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452250|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines (measles-mumps-rubella-varicella [MMRV: ProQuad], pneumococcal conjugate[PCV], and hepatitis A [HepA]) at age 12 months.
452251|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines (measles-mumps-rubella-varicella [MMR+V: ProQuad], pneumococcal conjugate [PCV], and hepatitis A [HepA]) at age 12 months. (0.5 mL, intramuscular, respectively)
452252|NCT00483574|O2|Outcome|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452253|NCT00483574|O1|Outcome|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452254|NCT00483574|E2|Reported Event|Group 2: Routine Pediatric Vaccines|Participants received routine pediatric vaccines, Measles, mumps and rubella (MMR: M-M-R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452255|NCT00483574|E1|Reported Event|Group 1: Menactra and Routine Pediatric Vaccines|Participants received Menactra alone at age 9 months and Menactra concomitantly with routine pediatric vaccines Measles, mumps and rubella (MMR: M‑M‑R®II) and varicella (V: Varivax), (0.5 mL Subcutaneous, respectively); pneumococcal conjugate (PCV), and hepatitis A (HepA) at age 12 months. (0.5 mL, intramuscular, respectively)
452256|NCT00483548|B3|Baseline|Total|Total of all reporting groups
452257|NCT00483548|B2|Baseline|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452258|NCT00483548|B1|Baseline|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452259|NCT00483548|P2|Participant Flow|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452260|NCT00483548|P1|Participant Flow|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452261|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452262|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452263|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452264|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452265|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452266|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452267|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452268|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452269|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452270|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452271|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452272|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452273|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452274|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452275|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452276|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452277|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452278|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452279|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452280|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452281|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452282|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452283|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452284|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452285|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452286|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452287|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452288|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452321|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452289|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452290|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452291|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452292|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452293|NCT00483548|O2|Outcome|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452294|NCT00483548|O1|Outcome|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452295|NCT00483548|E2|Reported Event|Placebo|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452296|NCT00483548|E1|Reported Event|Ziprasidone|Day 1: single dose of 40 milligrams (mg) by mouth (PO); Day 2: 40 mg po twice a day (BID); Day 3 through Week 6: flexible BID dosing titrated to a total daily dose of 40 mg, 60 mg, 80 mg, 100 mg, 120 mg, 140 mg, or 160 mg as adjunctive therapy with a mood stabilizer (lithium, valproate, or lamotrigine).
452297|NCT00483496|B1|Baseline|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
452298|NCT00483496|P1|Participant Flow|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
452299|NCT00483496|O8|Outcome|Vehicle|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452300|NCT00483496|O7|Outcome|TiO2Pig|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452301|NCT00483496|O6|Outcome|TiO2 Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452302|NCT00483496|O5|Outcome|Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452303|NCT00483496|O4|Outcome|TiO2Pig + TiO2Micro|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452304|NCT00483496|O3|Outcome|TiO2 Micro + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452305|NCT00483496|O2|Outcome|Ti02Pig + Bisoctrizole|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452306|NCT00483496|O1|Outcome|V0096|Each patient received each one of the 8 test products on their respective randomly allocated sites on grid (grid to be applied on the back skin; 1 product by grid window).
452307|NCT00483496|E1|Reported Event|Experimental|Each patient received the 8 test products on the 8 test areas of the randomly allocated grid.
452308|NCT00483379|B3|Baseline|Total|Total of all reporting groups
452309|NCT00483379|B2|Baseline|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452310|NCT00483379|B1|Baseline|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452311|NCT00483379|P2|Participant Flow|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452312|NCT00483379|P1|Participant Flow|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452313|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452314|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452315|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452316|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452317|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452318|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452319|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
453851|NCT00477269|O2|Outcome|Placebo|Placebo
452322|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452323|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452324|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452325|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452326|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452327|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452328|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452329|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452330|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452331|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452332|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452333|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452334|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452335|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452336|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452337|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452338|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452339|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452340|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452341|NCT00483379|O2|Outcome|Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452342|NCT00483379|O1|Outcome|Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452343|NCT00483379|E4|Reported Event|Extension: Alglucosidase Alfa 40 mg/kg Every Other Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
452344|NCT00483379|E3|Reported Event|Extension: Alglucosidase Alfa 20 mg/kg Every Week|The extension period of the study allowed late-onset participants access to the same treatment they took in the treatment period until the product was commercially available.
452345|NCT00483379|E2|Reported Event|Treatment: Alglucosidase Alfa 40 mg/kg Every Other Week|Participants were treated with alglucosidase alfa 40 mg/kg every other week for 52 weeks. This was the 'high dose' arm.
452346|NCT00483379|E1|Reported Event|Treatment: Alglucosidase Alfa 20 mg/kg Every Week|Participants were treated with alglucosidase alfa 20 mg/kg every week for 52 weeks. This was the 'frequent dose' arm.
452347|NCT00483327|B1|Baseline|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452348|NCT00483327|P1|Participant Flow|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452349|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452350|NCT00483327|O2|Outcome|Grade 3|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452351|NCT00483327|O1|Outcome|Grade 1 or 2|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452352|NCT00483327|O1|Outcome|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452353|NCT00483327|E1|Reported Event|Megestrol Acetate|80 mg (2 tablets) orally at breakfast, 80 mg at dinner for at least 12 weeks and up to 2 years.
452354|NCT00483262|B3|Baseline|Total|Total of all reporting groups
452355|NCT00483262|B2|Baseline|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib Phase II part of this Phase I/II study
452356|NCT00483262|B1|Baseline|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib Phase I part of this Phase I/II study.
452357|NCT00483262|P2|Participant Flow|CCI779 and Bortezomib Phase II|CCI779 and Bortezomib, Phase II part of this Phase I/II study
452358|NCT00483262|P1|Participant Flow|CCI779 and Bortezomib Phase I|CCI779 and Bortezomib, Phase I part of this Phase I/II study
452359|NCT00483262|O2|Outcome|CCI779 PFS Phase II|Progression-free survival results from the phase II part of the phase I/II CCI779 with velcade study.
452360|NCT00483262|O1|Outcome|CCI779 PFS Phase I|Progression-free survival results from the phase I part of the phase I/II CCI779 with velcade study.
452361|NCT00483262|O2|Outcome|CCI779 Response Phase II|Response of PR or better per the Blade criteria in phase II part of this phase I/II study of CCI779 and velcade
452364|NCT00483262|O1|Outcome|CCI779 Toxicity Phase I|Toxicity of CCI779 and velcade in the phase I part of this phase I/II study. CTC criteria used.
452365|NCT00483262|E2|Reported Event|Adverse Events CCI779 and Bortezomib Phase II|Adverse Events of CCI779 and Bortezomib in Phase II part of this Phase I/II study.
452366|NCT00483262|E1|Reported Event|Adverse Events CCI779 and Bortezomib Phase I|Adverse Events of CCI779 and Bortezomib in the phase I part of this phase I/II study.
452367|NCT00483184|B4|Baseline|Total|Total of all reporting groups
452368|NCT00483184|B3|Baseline|3|(Veldona)1000 IU IFNα bid
452369|NCT00483184|B2|Baseline|2|(Veldona)500 IU IFNα bid
452370|NCT00483184|B1|Baseline|1|(placebo)0 IU IFN alpha
452371|NCT00483184|P3|Participant Flow|3|(Veldona)1000 IU IFNα bid
452372|NCT00483184|P2|Participant Flow|2|(Veldona)500 IU IFNα bid
452373|NCT00483184|P1|Participant Flow|1|(placebo)0 IU IFN alpha
452374|NCT00483184|O3|Outcome|3|(Veldona)1000 IU IFNα bid
452375|NCT00483184|O2|Outcome|2|(Veldona)500 IU IFNα bid
452376|NCT00483184|O1|Outcome|1|(placebo)0 IU IFN alpha
452377|NCT00483184|E3|Reported Event|3|(Veldona)1000 IU IFNα bid
452378|NCT00483184|E2|Reported Event|2|(Veldona)500 IU IFNα bid
452379|NCT00483184|E1|Reported Event|1|(placebo)0 IU IFN alpha
452380|NCT00483119|B3|Baseline|Total|Total of all reporting groups
452381|NCT00483119|B2|Baseline|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452382|NCT00483119|B1|Baseline|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452383|NCT00483119|P2|Participant Flow|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452384|NCT00483119|P1|Participant Flow|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452385|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452386|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452387|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452388|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452389|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452390|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452391|NCT00483119|O2|Outcome|IVIg With Cyclophosphamide|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452392|NCT00483119|O1|Outcome|IVIg Alone|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452393|NCT00483119|E2|Reported Event|Group B|"IVIg with cyclophosphamide~cyclophosphamide: cyclophosphamide dose of 2mg/kg/day divided into three-times daily oral administration"
452394|NCT00483119|E1|Reported Event|Group A|"IVIg alone~intravenous immunoglobulin: Gamunex 10% 500/mg/kg/day x four days per cycle total of four cycles"
452395|NCT00483041|B3|Baseline|Total|Total of all reporting groups
452396|NCT00483041|B2|Baseline|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452397|NCT00483041|B1|Baseline|PLACEBO|Placebo administered as a single intravenous dose
452398|NCT00483041|P2|Participant Flow|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452399|NCT00483041|P1|Participant Flow|PLACEBO|Placebo administered as a single intravenous dose
452400|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452401|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452402|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452403|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452404|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452405|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452406|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452407|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452408|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452409|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452410|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452411|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452412|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452413|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452414|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452415|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452416|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452417|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452418|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452419|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452420|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452421|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452424|NCT00483041|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452425|NCT00483041|O1|Outcome|PLACEBO|Placebo administered as a single intravenous dose
452426|NCT00483041|E2|Reported Event|MEDI528 9 mg|MEDI-528 at a dose of 9 mg/kg administered as a single intravenous infusion
452427|NCT00483041|E1|Reported Event|PLACEBO|Placebo administered as a single intravenous dose
452428|NCT00483002|B1|Baseline|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452429|NCT00483002|P1|Participant Flow|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452430|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452431|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452432|NCT00483002|O1|Outcome|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452433|NCT00483002|E1|Reported Event|Varenicline|Varenicline tartrate tablets 0.5 milligram (mg) or 1 mg administered as per investigator’s discretion for 12 weeks.
452434|NCT00482911|B3|Baseline|Total|Total of all reporting groups
452435|NCT00482911|B2|Baseline|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
452436|NCT00482911|B1|Baseline|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
452437|NCT00482911|P2|Participant Flow|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
452438|NCT00482911|P1|Participant Flow|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
452439|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
452440|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
452441|NCT00482911|O2|Outcome|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
452442|NCT00482911|O1|Outcome|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
452443|NCT00482911|E2|Reported Event|Cohort 2-sunitinib & Cyclophosphamide|2 participants started Cycle 1 with Dose B as described above and had adjusted-dosing as described for Cohort 1. The remaining 7 participants began Cycle 1 with 10 mg Len, 25 mg Cyc and 12.5 mg Sun once daily (Dose D-QD). Doses were adjusted in subsequent cycles depending on toxicity, including step up to 10/50/12.5 mg Len/Cyc/Sun once daily (Dose E-QD) and step down to Dose D once every other day (Dose D-QOD).
452444|NCT00482911|E1|Reported Event|Cohort 1-lenalidomide & Cyclophosphamide|Participants first started on 2 Interventions (Dose A-QD) in Cycle 1, with 10 mg Lenalidomide (Len) once daily and 50 mg Cyclophosphamide (Cyc) once daily; 25 mg Sunitinib (Sun) was added once daily as a 3rd Intervention (Dose B-QD) from Cycle 2 onwards. Doses were adjusted in subsequent cycles depending on toxicity, including incremental step downs to 5/25/12.5 mg Len/Cyc/Sun once daily (Dose C-QD) or once every other day (Dose C-QOD).
452445|NCT00482625|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452446|NCT00482625|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452447|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452448|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452449|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452450|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452451|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452452|NCT00482625|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452453|NCT00482625|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive erlotinib hydrochloride PO QD for 21-42 days. Patients then proceed to surgery.~erlotinib hydrochloride: Given PO~conventional surgery: Undergo pancreatectomy~immunohistochemistry staining method: Correlative studies~protein expression analysis: Correlative studies~biopsy: Correlative studies~pharmacological study: Correlative studies~laboratory biomarker analysis: Correlative studies"
452454|NCT00482612|B5|Baseline|Total|Total of all reporting groups
452455|NCT00482612|B4|Baseline|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
452456|NCT00482612|B3|Baseline|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
452457|NCT00482612|B2|Baseline|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
452458|NCT00482612|B1|Baseline|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. No study medication was administered during the Follow-up Period.
452459|NCT00482612|P4|Participant Flow|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
452460|NCT00482612|P3|Participant Flow|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
452461|NCT00482612|P2|Participant Flow|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
452462|NCT00482612|P1|Participant Flow|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period. Participants were followed for safety during a Follow-up Period, in which no study medication was administered.
452463|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
452464|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452465|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
452466|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452467|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
452468|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452469|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
452470|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452471|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
452472|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452473|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
452474|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452475|NCT00482612|O4|Outcome|Placebo|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
452476|NCT00482612|O3|Outcome|Esmirtazapine 4.5 mg|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452477|NCT00482612|O2|Outcome|Esmirtazapine 3.0 mg|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
452478|NCT00482612|O1|Outcome|Esmirtazapine 1.5 mg|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452479|NCT00482612|E8|Reported Event|Placebo Follow-up|After receiving placebo in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
452480|NCT00482612|E7|Reported Event|Esmirtazapine 4.5 mg Follow-up|After receiving 4.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
452481|NCT00482612|E6|Reported Event|Esmirtazapine 3.0 mg Folow-up|After receiving 3.0 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
452482|NCT00482612|E5|Reported Event|Esmirtazapine 1.5 mg Follow-up|After receiving 1.5 mg esmirtazipine in the In-Treatment Period, participants were followed for safety during a Follow-up Period in which no study medication was administered.
452483|NCT00482612|E4|Reported Event|Placebo In-treatment|Participants took placebo tablets once daily by mouth during the 14-day In-treatment Period.
452484|NCT00482612|E3|Reported Event|Esmirtazapine 4.5 mg In-treatment|Participants took esmirtazapine 4.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452485|NCT00482612|E2|Reported Event|Esmirtazapine 3.0 mg In-Treatment|Participants took esmirtazapine 3.0 mg tablets once daily by mouth during the 14-day In-treatment Period.
452486|NCT00482612|E1|Reported Event|Esmirtazapine 1.5 mg In-treatment|Participants took esmirtazapine 1.5 mg tablets once daily by mouth during the 14-day In-treatment Period.
452487|NCT00482547|B3|Baseline|Total|Total of all reporting groups
452488|NCT00482547|B2|Baseline|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452489|NCT00482547|B1|Baseline|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452490|NCT00482547|P2|Participant Flow|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452491|NCT00482547|P1|Participant Flow|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452492|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452493|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452494|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452495|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452496|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452497|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452498|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452499|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452500|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452501|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452502|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452503|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452504|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452505|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452506|NCT00482547|O2|Outcome|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452507|NCT00482547|O1|Outcome|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452508|NCT00482547|E2|Reported Event|Silicone-coated Catheter|silicone elastomer-coated latex catheter
452509|NCT00482547|E1|Reported Event|Silver-coated Catheter|Bard® Hydrogel Silver Salts Coated Latex Urinary Catheter
452510|NCT00482274|B1|Baseline|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452511|NCT00482274|P1|Participant Flow|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452512|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452513|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452514|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452515|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452516|NCT00482274|O1|Outcome|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452517|NCT00482274|E1|Reported Event|Docetaxel|Subjects received 4-6 cycles of docetaxel at 75mg/m2 every 21 days.
452518|NCT00482170|B3|Baseline|Total|Total of all reporting groups
452519|NCT00482170|B2|Baseline|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452520|NCT00482170|B1|Baseline|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452521|NCT00482170|P2|Participant Flow|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg prefilled syringe (PFS) s.c. twice-weekly for 12 weeks.
452522|NCT00482170|P1|Participant Flow|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 milligram (mg) auto-injector (AI) subcutaneously (s.c.) twice-weekly for 12 weeks.
452523|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452524|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452525|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452526|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452527|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452528|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452529|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452530|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452531|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452532|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452533|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452534|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452535|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452536|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452537|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452538|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452539|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452540|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452541|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452542|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452543|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452544|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452545|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452546|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452547|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452548|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452549|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452550|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452551|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452552|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452553|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452554|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452555|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452556|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452557|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452558|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452559|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452560|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452561|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452562|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452563|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452564|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452565|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452566|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452567|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452568|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452569|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452570|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452571|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452572|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452573|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452574|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452575|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452576|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452577|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452578|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452579|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452580|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
453852|NCT00477269|O1|Outcome|STI571|STI571
452581|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452582|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452583|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452584|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452585|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452586|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452587|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452588|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452589|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452590|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452591|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452592|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452593|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452594|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452595|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452596|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452597|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452598|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452599|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452600|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452601|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452602|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452603|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452604|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452605|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452606|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452607|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452608|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452609|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452610|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452611|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452612|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452613|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452614|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452615|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452616|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452617|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452618|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452619|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452620|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452621|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452622|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452623|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452624|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452625|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452626|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452627|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452628|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452629|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452630|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452631|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452632|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452633|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
453853|NCT00477269|O2|Outcome|Placebo|Placebo
452634|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452635|NCT00482170|O2|Outcome|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452636|NCT00482170|O1|Outcome|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452637|NCT00482170|E2|Reported Event|Etanercept 50 mg Prefilled Syringe|Etanercept (Enbrel) 50 mg PFS s.c. twice-weekly for 12 weeks.
452638|NCT00482170|E1|Reported Event|Etanercept 50 mg Auto-injector|Etanercept (Enbrel) 50 mg AI s.c. twice-weekly for 12 weeks.
452639|NCT00482014|B5|Baseline|Total|Total of all reporting groups
452640|NCT00482014|B4|Baseline|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452641|NCT00482014|B3|Baseline|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452642|NCT00482014|B2|Baseline|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452643|NCT00482014|B1|Baseline|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452644|NCT00482014|P4|Participant Flow|Pemetrexed + Cisplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452645|NCT00482014|P3|Participant Flow|Pemetrexed + Carboplatin (Study Phase 2)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452646|NCT00482014|P2|Participant Flow|Pemetrexed + Cisplatin (Study Phase 1)|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452647|NCT00482014|P1|Participant Flow|Pemetrexed + Carboplatin (Study Phase 1)|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452648|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452649|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452650|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452651|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452652|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452653|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 Gray (Gy) total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452953|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452654|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452655|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452656|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452657|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 5 milligram/milliliter*minute (mg/mL*min) every 21 days for 3 cycles + radiation therapy (RT) 64-68 (Gray) Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452658|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452659|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452660|NCT00482014|O2|Outcome|Pemetrexed + Cisplatin Treatment|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452661|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452662|NCT00482014|O1|Outcome|Pemetrexed + Cisplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Gy total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452663|NCT00482014|O1|Outcome|Pemetrexed + Carboplatin Treatment Group|"500 milligrams/meter squared (mg/m²) pemetrexed (Pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452664|NCT00482014|E4|Reported Event|Phase 2: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin 75 mg/m² every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452665|NCT00482014|E3|Reported Event|Phase 2: Pemetrexed + Carboplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Carboplatin dosed at AUC 5 mg/mL*min every 21 days for 3 cycles + radiation therapy 64-68 Gy total dose given 2 Gy/day over 45 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452666|NCT00482014|E2|Reported Event|Phase 1: Pemetrexed + Cisplatin|"500 mg/m² pemetrexed every 21 days for 3 cycles + Cisplatin (Cis) 30 mg/m² or 75 mg/m² on Days 1, 8, 22, 29, 43 + radiation therapy 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Cis + RT) therapy."
452667|NCT00482014|E1|Reported Event|Phase 1: Pemetrexed + Carboplatin|"500 milligrams/meter squared (mg/m²) pemetrexed (pem) every 21 days for 3 cycles + Carboplatin (Carbo) dosed at area under the curve (AUC) 2 milligram/milliliter*minute (mg/mL*min) on Days 1, 8, 22, 29, 43 + radiation therapy (RT) 74 Grays (Gy) total dose given 2 Gy/day over 51 days.~Consolidation Therapy - 500 mg/m² pemetrexed, administered intravenously, every 21 days for 3 cycles beginning 3 weeks after completion of chemoradiation (Pem + Carbo + RT) therapy."
452668|NCT00481988|B3|Baseline|Total|Total of all reporting groups
452669|NCT00481988|B2|Baseline|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
452670|NCT00481988|B1|Baseline|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
453854|NCT00477269|O1|Outcome|STI571|STI571
452671|NCT00481988|P2|Participant Flow|Sham Iomed II Phoresor Transcranial Direct Current Stimulation|The sham group receives sham stimulation for the first two weeks of the study followed by active treatment in the second two weeks. To mimic the sensation of active treatment and maintain the blind of the study, in the sham arm the Iomed II Phoresor constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
452672|NCT00481988|P1|Participant Flow|Iomed II Phoresor Transcranial Direct Current Stimulation|The active group of patients will receive active Iomed II Phoresor transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation.
452673|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
452674|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
452675|NCT00481988|O2|Outcome|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
452676|NCT00481988|O1|Outcome|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
452677|NCT00481988|E2|Reported Event|Sham tDCS|the constant current generator is turned on for 10 seconds to produce the tingling sensation on the scalp experienced by the patients in the active arm but the generator is then turned off and the patients receive no stimulation for the remainder of the 20 minute session.
452678|NCT00481988|E1|Reported Event|Transcranial Direct Current Stimulation|one group of patients will receive active transcranial direct current stimulation for the first two weeks followed by another two weeks of active transcranial direct current stimulation, whereas the second group of patients will receive two weeks of sham transcranial direct current stimulation followed by two weeks of active transcranial direct current stimulation
452679|NCT00481871|B6|Baseline|Total|Total of all reporting groups
452680|NCT00481871|B5|Baseline|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452681|NCT00481871|B4|Baseline|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452682|NCT00481871|B3|Baseline|Phase 1 - Group C|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
452683|NCT00481871|B2|Baseline|Phase 1 - Group B|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
452684|NCT00481871|B1|Baseline|Phase 1 - Group A|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
452685|NCT00481871|P5|Participant Flow|Phase 2 Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452686|NCT00481871|P4|Participant Flow|Phase 2 Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452687|NCT00481871|P3|Participant Flow|Phase 1 Group C - Dose Finding|Phase 1 Treatment Group C had pralatrexate followed 1 hour later by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
452688|NCT00481871|P2|Participant Flow|Phase 1 Group B - Dose Finding|Phase 1 Treatment Group B had pralatrexate followed the next day by gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine. The starting dose was 10 mg/m2 of pralatrexate and 300 mg/m2 of gemcitabine.
452689|NCT00481871|P1|Participant Flow|Phase 1 Group A - Dose Finding|Phase 1 Treatment Group A had pralatrexate and gemcitabine administered on sequential days every week for 3 weeks followed by 1 week of rest (a 4 week cycle). The starting dose was 15 mg/m2 of pralatrexate and 400 mg/m2 of gemcitabine.
452690|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452691|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452692|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
453855|NCT00477269|O2|Outcome|Placebo|Placebo
452693|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452694|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452695|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
452696|NCT00481871|O3|Outcome|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452697|NCT00481871|O2|Outcome|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452698|NCT00481871|O1|Outcome|Phase 1|Includes the Phase 1 dose-finding groups A, B, and C
452699|NCT00481871|E3|Reported Event|Phase 2 - Group C|Phase 2 Treatment Group C had 15 mg/m2 of pralatrexate followed 1 hour later by 600 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatrexate and gemcitabine.
452700|NCT00481871|E2|Reported Event|Phase 2 - Group B|Phase 2 Treatment Group B had 10 mg/m2 of pralatrexate followed the next day by 400 mg/m2 of gemcitabine administered once every 2 weeks. One cycle of pralatrexate and gemcitabine was 4 weeks in duration and consisted of 2 doses each of pralatexate and gemcitabine.
452701|NCT00481871|E1|Reported Event|Phase 1|Patients that received at least one dose of pralatrexate in the Phase 1 portion of the study
452702|NCT00481845|B3|Baseline|Total|Total of all reporting groups
452703|NCT00481845|B2|Baseline|Anastrozole|Anastrozole as neoadjuvant therapy
452704|NCT00481845|B1|Baseline|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
452705|NCT00481845|P2|Participant Flow|Anastrozole|Anastrozole as neoadjuvant therapy
452706|NCT00481845|P1|Participant Flow|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
452707|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
452708|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
452709|NCT00481845|O2|Outcome|Anastrozole|Anastrozole as neoadjuvant therapy
452710|NCT00481845|O1|Outcome|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
452711|NCT00481845|E2|Reported Event|Anastrozole|Anastrozole as neoadjuvant therapy
452712|NCT00481845|E1|Reported Event|Vandetanib + Anastrozole|Vandetanib and Anastrozole as neoadjuvant therapy
452713|NCT00481767|B3|Baseline|Total|Total of all reporting groups
452714|NCT00481767|B2|Baseline|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452715|NCT00481767|B1|Baseline|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452716|NCT00481767|P2|Participant Flow|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452717|NCT00481767|P1|Participant Flow|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452718|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452719|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452720|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452721|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452722|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452723|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452724|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452725|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452726|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452727|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452728|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452729|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452730|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452731|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452732|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452733|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452734|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452735|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452736|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452737|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452738|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452739|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452740|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452741|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452742|NCT00481767|O2|Outcome|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452743|NCT00481767|O1|Outcome|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452744|NCT00481767|E2|Reported Event|Placebo Group|Female subjects received 3 doses of placebo at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452745|NCT00481767|E1|Reported Event|Cervarix Group|Female subjects received 3 doses of Cervarix at Month 0, 1 and 6 intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
452746|NCT00481676|B3|Baseline|Total|Total of all reporting groups
452747|NCT00481676|B2|Baseline|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452748|NCT00481676|B1|Baseline|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452749|NCT00481676|P2|Participant Flow|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452750|NCT00481676|P1|Participant Flow|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452751|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452752|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
453756|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
452753|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452754|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452755|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452756|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452757|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452758|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452759|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452760|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452761|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452762|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452763|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452764|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452765|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452766|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452767|NCT00481676|O2|Outcome|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452768|NCT00481676|O1|Outcome|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452769|NCT00481676|E2|Reported Event|Placebo to Omalizumab|Placebo to omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452770|NCT00481676|E1|Reported Event|Omalizumab 75-375 mg|Omalizumab was dosed at 75 to 375 mg according to baseline IgE and body weight as described in dosing tables in the study protocol. Dosing occurred subcutaneously every 2 or 4 weeks depending on dose.
452771|NCT00480636|B1|Baseline|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452772|NCT00480636|P1|Participant Flow|Dalteparin|Dalteparin 200 International Units per kilogram (IU/kg) total body weight subcutaneously (SC) once daily (QD) for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452773|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452774|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452775|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452776|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452777|NCT00480636|O1|Outcome|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452778|NCT00480636|E1|Reported Event|Dalteparin|Dalteparin 200 IU/kg total body weight SC QD for Month 1, then 150 IU/kg total body weight SC QD from Months 2 to 6.
452779|NCT00481507|B3|Baseline|Total|Total of all reporting groups
452780|NCT00481507|B2|Baseline|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
452781|NCT00481507|B1|Baseline|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
452782|NCT00481507|P2|Participant Flow|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
452783|NCT00481507|P1|Participant Flow|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
452784|NCT00481507|O2|Outcome|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
452785|NCT00481507|O1|Outcome|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
452786|NCT00481507|E2|Reported Event|Kefir|150mL per day, administered orally for 10 consecutive days. Active kefir contained probiotics Lactococcus lactis, Lactococcus plantarum, Lactococcus rhamnosus, Lactococcus casei, Lactococcus lactis subspecies diacetylactis, Leuconostoc cremoris, Bifidobacterium longum, Bifidobacterium breve, Lactobacillus acidophilus, and 1 yeast, Saccharomyces florentinus.
452787|NCT00481507|E1|Reported Event|Placebo|150mL per day, administered orally for 10 consecutive days. Placebo was heat-treated to kill all cultures.
452788|NCT00481351|B3|Baseline|Total|Total of all reporting groups
452789|NCT00481351|B2|Baseline|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452790|NCT00481351|B1|Baseline|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452791|NCT00481351|P2|Participant Flow|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452792|NCT00481351|P1|Participant Flow|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452793|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452794|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452795|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452796|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452797|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452798|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452799|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452800|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452801|NCT00481351|O2|Outcome|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452802|NCT00481351|O1|Outcome|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452803|NCT00481351|E2|Reported Event|Group 2 Simvastatin|6 week simvastatin 20mg once a day followed by 6 week simvastatin 80mg once a day.
452804|NCT00481351|E1|Reported Event|group1 Ezetimibe|6 week wash out, followed by 06 week ezetimibe 10mg once a day e then 6 week ezetimibe 10mg plus sinvastatin 20mg for more 6 week.
452805|NCT00481247|B3|Baseline|Total|Total of all reporting groups
452806|NCT00481247|B2|Baseline|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452807|NCT00481247|B1|Baseline|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452808|NCT00481247|P2|Participant Flow|Imatinib|Tablets, oral, imatinib 400mg once daily (QD)
452809|NCT00481247|P1|Participant Flow|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452810|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452811|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452812|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452813|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452814|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452815|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452816|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452817|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452818|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452819|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452820|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452821|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452822|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452823|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452824|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452825|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452826|NCT00481247|O2|Outcome|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452827|NCT00481247|O1|Outcome|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452828|NCT00481247|E2|Reported Event|Imatinib|Tablets, oral, imatinib 400 mg once daily (QD)
452829|NCT00481247|E1|Reported Event|Dasatinib|Tablets, oral, dasatinib 100 mg once daily (QD)
452830|NCT00481195|B3|Baseline|Total|Total of all reporting groups
452840|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452831|NCT00481195|B2|Baseline|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452832|NCT00481195|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452833|NCT00481195|P2|Participant Flow|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452834|NCT00481195|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452835|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452836|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452837|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452838|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452839|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452936|NCT00481065|B3|Baseline|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453116|NCT00480493|E2|Reported Event|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
452841|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452842|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452843|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452844|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452845|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452846|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452847|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452848|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452849|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452937|NCT00481065|B2|Baseline|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453117|NCT00480493|E1|Reported Event|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
452850|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452851|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452852|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452853|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452854|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452855|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452856|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452857|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452858|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452938|NCT00481065|B1|Baseline|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452939|NCT00481065|P8|Participant Flow|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452859|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452860|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452861|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452862|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452863|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452864|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452865|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452866|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452867|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452940|NCT00481065|P7|Participant Flow|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452941|NCT00481065|P6|Participant Flow|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452868|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452869|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452870|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452871|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452872|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452873|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452874|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452875|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452876|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452942|NCT00481065|P5|Participant Flow|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452943|NCT00481065|P4|Participant Flow|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453118|NCT00480324|B3|Baseline|Total|Total of all reporting groups
453856|NCT00477269|O1|Outcome|STI571|STI571
452877|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452878|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452879|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452880|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452881|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452882|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452883|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452884|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452885|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452944|NCT00481065|P3|Participant Flow|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453119|NCT00480324|B2|Baseline|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
452886|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452887|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452888|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452889|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452890|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452891|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452892|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452893|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452894|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452945|NCT00481065|P2|Participant Flow|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452951|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452895|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452896|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452897|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452898|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452899|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452900|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452901|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452902|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452903|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452946|NCT00481065|P1|Participant Flow|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452947|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452904|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452905|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452906|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452907|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452908|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452909|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452910|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452911|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452912|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452948|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452949|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452952|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452913|NCT00481195|O2|Outcome|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452914|NCT00481195|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452915|NCT00481195|E2|Reported Event|Placebo|Placebo tablets matching the 50 mg armodafinil tablet were used in a manner identical to that of the armodafinil tablets. Study drug was titrated up to the target dosage of 3 tablets / day (daily dose was administered each morning). Patients began taking blinded study drug at a dose of 1 tablet daily on the day following the baseline visit. Doses were increased by 1 tablet to a dose of 2 tablets/day on Day 2 and 3, and then again by 1 tablet /day on day 4 for a target dose of 3 tablets/day. Following titration, patients continued taking 3 tablets/day of study drug for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 2 tablets/day) was allowed. The dosage could not be increased after it was decreased.
452916|NCT00481195|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil was titrated up to the target dosage of 150 mg/day (daily dose was administered each morning). Patients began taking blinded armodafinil at a dose of 50 mg/day (1 tablet) on the day following the baseline visit. Doses were increased by 50 mg/day (1 tablet) to a dose of 100 mg/day on Day 2 and 3, and then again by 50 mg /day on day 4 for a target dose of 150 mg/day. Following titration, patients continued taking 150 mg/day of armodafinil for the duration of the study. If a patient was unable to tolerate (recurrent or persistent adverse events) the study drug, 1 reduction in dosage (ie, minimum dosage 100 mg/day [2 tablets]) was allowed. The dosage could not be increased after it was decreased.
452917|NCT00481078|B3|Baseline|Total|Total of all reporting groups
452918|NCT00481078|B2|Baseline|Arm 2|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452919|NCT00481078|B1|Baseline|Arm 1|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452920|NCT00481078|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452921|NCT00481078|P1|Participant Flow|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452922|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452923|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452924|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452925|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452926|NCT00481078|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452927|NCT00481078|O1|Outcome|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452928|NCT00481078|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin)|Patients receive an oral placebo once daily on days 1-14 and paclitaxel and carboplatin as in arm l.
452929|NCT00481078|E1|Reported Event|Arm I (Vorinostat, Paclitaxel, Carboplatin)|Patients receive oral vorinostat (SAHA) at 400 mg once daily on days 1-14 and paclitaxel IV 200 mg/m2 over 3 hours and carboplatin IV dosed to achieve an area under the concentration versus time curve of 6 mg/mLXmin over 30 minutes on day 3.
452930|NCT00481065|B9|Baseline|Total|Total of all reporting groups
452931|NCT00481065|B8|Baseline|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452932|NCT00481065|B7|Baseline|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452933|NCT00481065|B6|Baseline|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452934|NCT00481065|B5|Baseline|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452935|NCT00481065|B4|Baseline|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452950|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452954|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452955|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452956|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452957|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452958|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452959|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452960|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452961|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452962|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452963|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452964|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452965|NCT00481065|O2|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452966|NCT00481065|O1|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452967|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452968|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452969|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452970|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452971|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452972|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452973|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452974|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452975|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452976|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452977|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452978|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452979|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452980|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452981|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452982|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452983|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452984|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452985|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452986|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452987|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452988|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452989|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452990|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452991|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452992|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452993|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452994|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
452995|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452996|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452997|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452998|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
452999|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453000|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453001|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453002|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
453003|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453004|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453005|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453006|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453007|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453008|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453009|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453010|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
453011|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453012|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453013|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453014|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453015|NCT00481065|O8|Outcome|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453016|NCT00481065|O7|Outcome|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453017|NCT00481065|O6|Outcome|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453018|NCT00481065|O5|Outcome|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
453019|NCT00481065|O4|Outcome|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453020|NCT00481065|O3|Outcome|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453757|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453021|NCT00481065|O2|Outcome|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453022|NCT00481065|O1|Outcome|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453023|NCT00481065|E8|Reported Event|eTIV_a+MF59-eH5N1|1 dose of eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453024|NCT00481065|E7|Reported Event|MF59-eH5N1+eTIV_a|1 dose of MF59-eH5N1 on day 1, 1 dose of eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453025|NCT00481065|E6|Reported Event|Mixed+MF59-eH5N1|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453026|NCT00481065|E5|Reported Event|Mixed + Mixed|dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1, day 22, and day 382
453027|NCT00481065|E4|Reported Event|Mixed|1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 1 and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453028|NCT00481065|E3|Reported Event|Concomitant+MF59-eH5N1|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453029|NCT00481065|E2|Reported Event|Concomitant+Mixed|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1, 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 22, and 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453030|NCT00481065|E1|Reported Event|Concomitant Alone|1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 into one arm and 1 dose of eTIV_a into the other arm on day 1 then 1 dose of MF59-eH5N1 mixed extemporaneously with eTIV_a on day 382
453031|NCT00480987|B1|Baseline|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
453032|NCT00480987|P1|Participant Flow|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
453033|NCT00480987|O1|Outcome|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
453034|NCT00480987|E1|Reported Event|Oxaliplatin + Cytarabine + Fludarabine|Oxaliplatin 30 mg/m^2 intravenous (IV) days 1-4, Cytarabine 500 mg/m^2 by IV continuous infusion days 2-6, Fludarabine 30 mg/m^2 IV days 2-6
453035|NCT00480857|B1|Baseline|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
453036|NCT00480857|P1|Participant Flow|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
453037|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
453038|NCT00480857|O1|Outcome|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
453039|NCT00480857|E1|Reported Event|Docetaxel|Docetaxel (Taxotere): Concurrent weekly docetaxel at 20mg/m2 with radiation therapy. Chemo dose may be held or reduced based on specific lab parameters.
453040|NCT00480779|B3|Baseline|Total|Total of all reporting groups
453041|NCT00480779|B2|Baseline|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
453042|NCT00480779|B1|Baseline|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
453043|NCT00480779|P2|Participant Flow|GLB DVD|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
453044|NCT00480779|P1|Participant Flow|GLB Group|The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study chose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.
453120|NCT00480324|B1|Baseline|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453045|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453046|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453047|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453048|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453049|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453050|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453051|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453121|NCT00480324|P2|Participant Flow|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453122|NCT00480324|P1|Participant Flow|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453123|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453124|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453125|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453126|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453052|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453053|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453054|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453055|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453056|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453057|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453058|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453127|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453128|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453129|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453130|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453131|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453132|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453059|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453060|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453061|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453062|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453063|NCT00480779|O2|Outcome|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453064|NCT00480779|O1|Outcome|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453065|NCT00480779|E2|Reported Event|GLB DVD|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Those who took part via DVD received an overview of the GLB program at the first session, as well as the materials needed for the program. They subsequently watched one session of the program each week, and received a telephone call from a trained lifestyle coach each week to review weight, physical activity minutes and questions/concerns regarding the program. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB DVD:The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered via DVD and"
453133|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453134|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453135|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453136|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453137|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453138|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453066|NCT00480779|E1|Reported Event|GLB Group|"The Group Lifestyle Balance program is a direct adaptation of the Diabetes Prevention Program lifestyle intervention. Participants in the study choose traditional GLB face-to-face group delivery or delivery via DVD. Group members met weekly and completed the program over a 12-15 week period. The face-to-face group meetings were led by a trained lifestyle coach, and participants were encouraged to self-monitor their eating and physical activity behaviors. Participants in both intervention delivery modes received a GLB workbook, fat and calorie counter, pedometer, and self-monitoring books for tracking food intake and physical activity.~GLB Group: The Group Lifestyle Balance (GLB) program is a lifestyle change program adapted from the successful lifestyle intervention utilized in the Diabetes Prevention Program. For this arm, the intervention is delivered in face-to-face groups by a trained lifestyle coach."
453067|NCT00480740|B4|Baseline|Total|Total of all reporting groups
453068|NCT00480740|B3|Baseline|Fontan Physiology|
453069|NCT00480740|B2|Baseline|Cardiac Transplant|
453070|NCT00480740|B1|Baseline|Normal Physiology|
453071|NCT00480740|P3|Participant Flow|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
453072|NCT00480740|P2|Participant Flow|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
453073|NCT00480740|P1|Participant Flow|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
453074|NCT00480740|O3|Outcome|Fontan Physiology|diagnostic cardiac catheterization in children with a transplanted ventricle
453075|NCT00480740|O2|Outcome|Cardiac Transplant|diagnostic cardiac catheterization in children with a transplanted heart
453076|NCT00480740|O1|Outcome|Normal Physiology|diagnostic cardiac catheterization in children with normal cardiac physiology
453077|NCT00480740|E3|Reported Event|Normal Physiology|"control group~Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization"
453078|NCT00480740|E2|Reported Event|Fontan Procedure|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
453079|NCT00480740|E1|Reported Event|Cardiac Transplant|Dexmedetomidine: Dexmedetomidine load of 1 microgram/kilogram over 10 minutes, followed by a 1 microgram/kilogram/hour infusion during the time of catheterization
453080|NCT00480532|B5|Baseline|Total|Total of all reporting groups
453081|NCT00480532|B4|Baseline|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453082|NCT00480532|B3|Baseline|Placebo (Prevention)|Placebo for prevention portion of the study
453083|NCT00480532|B2|Baseline|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453084|NCT00480532|B1|Baseline|Placebo (Treatment)|Placebo (for treatment portion of the study)
453085|NCT00480532|P4|Participant Flow|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453086|NCT00480532|P3|Participant Flow|Placebo (Prevention)|Placebo for prevention portion of the study
453087|NCT00480532|P2|Participant Flow|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453088|NCT00480532|P1|Participant Flow|Placebo (Treatment)|Placebo (for treatment portion of the study)
453089|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453090|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
453091|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453092|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
453093|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453094|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
453095|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453096|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
453097|NCT00480532|O4|Outcome|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453098|NCT00480532|O3|Outcome|Placebo (Prevention)|Placebo for prevention portion of the study
453099|NCT00480532|O2|Outcome|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453100|NCT00480532|O1|Outcome|Placebo (Treatment)|Placebo (for treatment portion of the study)
453101|NCT00480532|E4|Reported Event|Subantibmicrobial Dose Doxy|Doxycycline 40mg (sustained release) once daily for 84 days
453102|NCT00480532|E3|Reported Event|Placebo (Prevention)|Placebo for prevention portion of the study
453103|NCT00480532|E2|Reported Event|Doxy (7 Day Treatment Arm)|Doxycycline 100 mg po bid x 7 days taken when bleeding occurred
453104|NCT00480532|E1|Reported Event|Placebo (Treatment)|Placebo (for treatment portion of the study)
453105|NCT00480493|B3|Baseline|Total|Total of all reporting groups
453106|NCT00480493|B2|Baseline|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
453107|NCT00480493|B1|Baseline|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
453108|NCT00480493|P2|Participant Flow|Control Arm|Parent in this group receives parent contact phone number that they can call for parent support
453109|NCT00480493|P1|Participant Flow|Parent Mentor Contact|Parent mentor provides face-to-face, phone and/or e-mail social support
453110|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
453111|NCT00480493|O1|Outcome|Parent Contact Control Arm|
453112|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|
453113|NCT00480493|O1|Outcome|Parent Contact Control Arm|
453114|NCT00480493|O2|Outcome|Parent Mentor Experimental Arm|Parent mentor experimental arm had an assigned experienced parent raising a child with type 1 diabetes. The experienced parent mentor contacted the parent and negotiated the intervention dose, depending on need.
453115|NCT00480493|O1|Outcome|Parent Contact Control Arm|Parent contact control arm had a phone number only to call an experienced parent raising a child with type 1 diabetes to discuss support. The experienced parent contact did not initiate the contact.
453139|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453140|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453141|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453142|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453143|NCT00480324|O2|Outcome|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453144|NCT00480324|O1|Outcome|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453145|NCT00480324|E2|Reported Event|Placebo Group|Subjects received 2 oral doses of placebo according to a 0, 1 month schedule.
453146|NCT00480324|E1|Reported Event|Rotarix Group|Subjects received 2 oral doses of Rotarix according to a 0, 1 month schedule.
453147|NCT00479882|B5|Baseline|Total|Total of all reporting groups
453148|NCT00479882|B4|Baseline|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
453149|NCT00479882|B3|Baseline|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
453150|NCT00479882|B2|Baseline|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
453151|NCT00479882|B1|Baseline|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
453152|NCT00479882|P4|Participant Flow|Sequence 4: MK-0524A 2g+Simvastatin 40mg →MK-0524B 1.8g/40mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 40 mg for 4 weeks, then co-administration MK-0524A 2g +simvastatin 40 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/40 mg combination tablet for 8 weeks.
453153|NCT00479882|P3|Participant Flow|Sequence 3: MK-0524B 1.8g/40mg→MK-0524A 2g+Simvastatin 40mg|After a 2-week placebo run-in, participants will receive MK-0524B 0.9g/40 mg combination tablet for 4 weeks, then MK-0524B 1.8g /40 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 40 mg for 8 weeks.
453154|NCT00479882|P2|Participant Flow|Sequence 2: MK-0524A 2g+Simvastatin 20mg →MK-0524B 1.8g/20mg|After a 2-week placebo run-in, participants will be co-administered MK-0524A 1g + simvastatin 10 mg for 4 weeks, then co-administered MK-0524A 2g +simvastatin 20 mg for 8 weeks. Participant then receives MK-0524B 1.8 g/20 mg combination tablet for 8 weeks.
453155|NCT00479882|P1|Participant Flow|Sequence 1: MK-0524B 1.8g/20mg→MK-0524A 2g+Simvastatin 20mg|After a 2-week placebo run-in, participants will receive MK-0524B (0.9 g/simvastatin 10 mg) for 4 weeks, then MK-0524B 1.8g /20 mg combination tablet for 8 weeks. Participant is then co-administered MK-0524A 2 g + simvastatin 20 mg for 8 weeks.
453156|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
453157|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
453158|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
453159|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
453160|NCT00479882|O4|Outcome|MK-0524A 1 g + Simvastatin 40 mg|Participants who received MK-0524A 1g+Simvastatin 40mg for 4 weeks in Period I regardless of randomly assigned sequence.
453161|NCT00479882|O3|Outcome|MK-0524B 0.9 g/40 mg|Participants who received MK-0524B 0.9g/40mg for 4 weeks in Period I regardless of randomly assigned sequence.
453162|NCT00479882|O2|Outcome|MK-0524A 1g+Simvastatin 10mg|Participants who received MK-0524A 1g+Simvastatin 10mg for 4 weeks in Period I regardless of randomly assigned sequence.
453163|NCT00479882|O1|Outcome|MK-0524B 0.9g/10mg|Participants who received MK-0524B 0.9g/10mg for 4 weeks in Period I regardless of randomly assigned sequence.
453164|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453165|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453166|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453167|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453168|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453169|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453170|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453171|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453172|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453173|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453174|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453758|NCT00478192|E3|Reported Event|Regimen 3 Placebo|
453175|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453176|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453177|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453178|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453179|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453180|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453181|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453182|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453183|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453184|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453185|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453186|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453187|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453188|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453189|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453190|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453191|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453192|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453193|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453194|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453195|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453196|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453197|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453198|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453199|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453200|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453201|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453202|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453203|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453204|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453205|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453206|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453207|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453208|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453209|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453210|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453211|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453212|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453213|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453214|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453215|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453216|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453217|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453218|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453219|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453220|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453221|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453222|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453223|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453224|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453225|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453226|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453227|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453228|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453229|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453230|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453231|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453232|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453233|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453234|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453235|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453236|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453237|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453238|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453239|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453240|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453241|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453242|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453243|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453244|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453245|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453246|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453247|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453248|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453249|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453250|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453251|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453252|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453253|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453254|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453255|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453256|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453257|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453258|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453259|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453260|NCT00479882|O8|Outcome|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453261|NCT00479882|O7|Outcome|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453262|NCT00479882|O6|Outcome|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II.
453263|NCT00479882|O5|Outcome|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453264|NCT00479882|O4|Outcome|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453265|NCT00479882|O3|Outcome|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Period III
453266|NCT00479882|O2|Outcome|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 1g + Simvastatin 20mg and MK-0524A 2g+ Simvastatin 20mg during Periods I/II.
453267|NCT00479882|O1|Outcome|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453268|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453269|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
453270|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453271|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453272|NCT00479882|O4|Outcome|MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 2g+Simvastatin 40mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453273|NCT00479882|O3|Outcome|MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg for 8 weeks in either Period II or Period III treatment period regardless of randomly assigned sequence.
453274|NCT00479882|O2|Outcome|MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524A 2g+Simvastatin 20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453275|NCT00479882|O1|Outcome|MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg for 8 weeks in either Period II or Period III regardless of randomly assigned sequence.
453276|NCT00479882|E8|Reported Event|Sequence 4: MK-0524B 1.8g/40mg|Participants who received MK-0524B 1.8g/40mg during Periods III
453277|NCT00479882|E7|Reported Event|Sequence 3: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Period III
453278|NCT00479882|E6|Reported Event|Sequence 4: MK-0524A 2g+Simvastatin 40mg|Participants who received MK-0524A 1g + Simvastatin 40mg and MK-0524A 2g+ Simvastatin 40mg during Periods I/II
453279|NCT00479882|E5|Reported Event|Sequence 3: MK-0524B 1.8g/40mg|Participants who received MK-0524B 0.9g/40mg and MK-0524B 1.8g/40mg during Periods I/II
453280|NCT00479882|E4|Reported Event|Sequence 2: MK-0524B 1.8g/20mg|Participants who received MK-0524B 1.8g/20mg during Periods III
453281|NCT00479882|E3|Reported Event|Sequence 1: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Period III
453282|NCT00479882|E2|Reported Event|Sequence 2: MK-0524A 2g+Simvastatin 20mg|Participants who received MK-0524B 1g + Simvastatin 20mg and MK-0524B 2g+ Simvastatin 20mg during Periods I/II
453283|NCT00479882|E1|Reported Event|Sequence 1: MK-0524B 1.8g/20mg|Participants who received MK-0524B 0.9g/20mg and MK-0524B 1.8g/20mg during Periods I/II
453284|NCT00479856|B1|Baseline|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453285|NCT00479856|P1|Participant Flow|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453286|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453287|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453288|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453289|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453340|NCT00479557|P7|Participant Flow|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453290|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453291|NCT00479856|O1|Outcome|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453292|NCT00479856|E1|Reported Event|Lapatinib + Chemotherapy|"1250 milligrams (mg) Lapatinib taken once daily on a continuous basis plus one of the following chemotherapies:~(1) 1000 mg/square meters (m2) Capecitabine taken twice a day on Days 1-14 every 21 days; (2) 75 mg/m2 Docetaxel administered as a single infusion once every 21 days; or (3) 100 mg/m2 nab-Paclitaxel administered as a single infusion once every 7 days for 21 days, followed by 7 days of rest in a 28-day cycle"
453293|NCT00479765|B1|Baseline|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
453294|NCT00479765|P1|Participant Flow|OncoGel|"OncoGel administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
453295|NCT00479765|O1|Outcome|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
453296|NCT00479765|E1|Reported Event|OncoGel 5mL|"OncoGel 5 mL administered into remaining cavity after surgical resection. Each dose cohort will receive a different volume of OncoGel~OncoGel (ReGel/Paclitaxel): OncoGel administered into cavity after surgical resection of recurrent glioma. Each subject will receive one dose of OncoGel on the day of surgical resection."
453297|NCT00479713|B3|Baseline|Total|Total of all reporting groups
453298|NCT00479713|B2|Baseline|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453299|NCT00479713|B1|Baseline|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453300|NCT00479713|P2|Participant Flow|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453301|NCT00479713|P1|Participant Flow|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453302|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453303|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453304|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453305|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453306|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453307|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453308|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453309|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453310|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453311|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453312|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453313|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453314|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453315|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453316|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453317|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453318|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453319|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453320|NCT00479713|O2|Outcome|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453321|NCT00479713|O1|Outcome|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453322|NCT00479713|E2|Reported Event|Rosuvastatin|Rosuvastatin 10 mg plus a matching placebo for the combination tablet QD (once a day) for 6 weeks
453323|NCT00479713|E1|Reported Event|Ezetemibe + Simvastatin|Ezetemibe 10 mg + Simvastatin 20 mg plus a matching placebo for rosuvastatin 10 mg QD (once a day) for 6 weeks
453759|NCT00478192|E2|Reported Event|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453324|NCT00479674|B1|Baseline|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453325|NCT00479674|P1|Participant Flow|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453326|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453327|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453328|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453329|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453330|NCT00479674|O1|Outcome|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453331|NCT00479674|E1|Reported Event|Abraxane, Carboplatin, Bevacizumab|"Abraxane 100 mg/m2 IV over 30 min days 1,8,15.; Carboplatin AUC=2 IV over 15 min days 1,8,15., Bevacizumab 10 mg/kg IV days 1,15~Abraxane: 100 mg/m2 IV over 30 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death..~Bevacizumab: 10 mg/kg IV days 1,15 Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria,intolerable toxicity, or death.~Carboplatin: area under curve (AUC)=2 IV over 15 min days 1,8,15. Cycles Repeated Every 28 days until documented evidence of disease progression by RECIST criteria, intolerable toxicity, or death."
453332|NCT00479557|B8|Baseline|Total|Total of all reporting groups
453333|NCT00479557|B7|Baseline|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453334|NCT00479557|B6|Baseline|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453335|NCT00479557|B5|Baseline|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453336|NCT00479557|B4|Baseline|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453337|NCT00479557|B3|Baseline|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453338|NCT00479557|B2|Baseline|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453339|NCT00479557|B1|Baseline|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453341|NCT00479557|P6|Participant Flow|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453342|NCT00479557|P5|Participant Flow|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453343|NCT00479557|P4|Participant Flow|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453344|NCT00479557|P3|Participant Flow|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453345|NCT00479557|P2|Participant Flow|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453346|NCT00479557|P1|Participant Flow|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453347|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453348|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453349|NCT00479557|O5|Outcome|ACC 30 μg|Participants received 30 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453350|NCT00479557|O4|Outcome|ACC 10 μg|Participants received 10 μg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453351|NCT00479557|O3|Outcome|ACC 30 μg+QS-21|Participants received 30 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453352|NCT00479557|O2|Outcome|ACC 10 μg+QS-21|Participants received 10 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453353|NCT00479557|O1|Outcome|ACC 3 μg+QS-21|Participants received 3 μg of ACC-001 and 50 μg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453354|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453355|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453356|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453357|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453358|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453359|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453360|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453361|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453362|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453363|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453364|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453365|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453366|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453367|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453368|NCT00479557|O7|Outcome|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453369|NCT00479557|O6|Outcome|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453370|NCT00479557|O5|Outcome|ACC 30 µg|Participants received 30 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453371|NCT00479557|O4|Outcome|ACC 10 µg|Participants received 10 µg of ACC. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453372|NCT00479557|O3|Outcome|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453373|NCT00479557|O2|Outcome|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453374|NCT00479557|O1|Outcome|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453375|NCT00479557|E7|Reported Event|Phosphate Buffered Saline|Participants received Phosphate buffered Saline (PBS). Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453448|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453376|NCT00479557|E6|Reported Event|QS-21 Alone|Participants received 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453377|NCT00479557|E5|Reported Event|ACC 30 µg|Participants received 30 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453378|NCT00479557|E4|Reported Event|ACC 10 µg|Participants received 10 µg of ACC-001. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453379|NCT00479557|E3|Reported Event|ACC 30 µg+QS-21|Participants received 30 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453380|NCT00479557|E2|Reported Event|ACC 10 µg+QS-21|Participants received 10 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453381|NCT00479557|E1|Reported Event|ACC 3 µg+QS-21|Participants received 3 µg of ACC-001 and 50 µg of QS-21. Test article was given by intramuscular injection into the deltoid muscle at 0, 1, 3, 6, and 12 months.
453382|NCT00479466|B7|Baseline|Total|Total of all reporting groups
453383|NCT00479466|B6|Baseline|Metformin HCL|
453384|NCT00479466|B5|Baseline|MK0893 80 mg|
453385|NCT00479466|B4|Baseline|MK0893 60 mg|
453386|NCT00479466|B3|Baseline|MK0893 40 mg|
453387|NCT00479466|B2|Baseline|MK0893 20 mg|
453388|NCT00479466|B1|Baseline|Placebo|
453389|NCT00479466|P6|Participant Flow|Metformin HCL|
453390|NCT00479466|P5|Participant Flow|MK0893 80 mg|
453391|NCT00479466|P4|Participant Flow|MK0893 60 mg|
453392|NCT00479466|P3|Participant Flow|MK0893 40 mg|
453393|NCT00479466|P2|Participant Flow|MK0893 20 mg|
453394|NCT00479466|P1|Participant Flow|Placebo|
453395|NCT00479466|O6|Outcome|Metformin HCL|
453396|NCT00479466|O5|Outcome|MK0893 80 mg|
453397|NCT00479466|O4|Outcome|MK0893 60 mg|
453398|NCT00479466|O3|Outcome|MK0893 40 mg|
453399|NCT00479466|O2|Outcome|MK0893 20 mg|
453400|NCT00479466|O1|Outcome|Placebo|
453401|NCT00479466|O6|Outcome|Metformin HCL|
453402|NCT00479466|O5|Outcome|MK0893 80 mg|
453403|NCT00479466|O4|Outcome|MK0893 60 mg|
453404|NCT00479466|O3|Outcome|MK0893 40 mg|
453405|NCT00479466|O2|Outcome|MK0893 20 mg|
453406|NCT00479466|O1|Outcome|Placebo|
453407|NCT00479466|O6|Outcome|Metformin HCL|
453408|NCT00479466|O5|Outcome|MK0893 80 mg|
453409|NCT00479466|O4|Outcome|MK0893 60 mg|
453410|NCT00479466|O3|Outcome|MK0893 40 mg|
453411|NCT00479466|O2|Outcome|MK0893 20 mg|
453412|NCT00479466|O1|Outcome|Placebo|
453413|NCT00479466|E6|Reported Event|Metformin HCL|
453414|NCT00479466|E5|Reported Event|MK0893 80 mg|
453415|NCT00479466|E4|Reported Event|MK0893 60 mg|
453416|NCT00479466|E3|Reported Event|MK0893 40 mg|
453417|NCT00479466|E2|Reported Event|MK0893 20 mg|
453418|NCT00479466|E1|Reported Event|Placebo|
453419|NCT00479401|B4|Baseline|Total|Total of all reporting groups
453420|NCT00479401|B3|Baseline|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453421|NCT00479401|B2|Baseline|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453422|NCT00479401|B1|Baseline|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453423|NCT00479401|P3|Participant Flow|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453424|NCT00479401|P2|Participant Flow|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453425|NCT00479401|P1|Participant Flow|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453426|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453427|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453428|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453429|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453430|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453431|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453432|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453433|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453434|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453435|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453436|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453437|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453438|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453439|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453440|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453441|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453442|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453443|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453444|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453445|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453446|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453447|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453449|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453450|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453451|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453452|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453453|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453454|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453455|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453456|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453457|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453458|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453459|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453460|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453461|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453462|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453463|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453464|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453465|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453466|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453467|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453468|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453469|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453470|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453471|NCT00479401|O3|Outcome|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453472|NCT00479401|O2|Outcome|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453473|NCT00479401|O1|Outcome|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453474|NCT00479401|E3|Reported Event|Placebo|Placebo to PPX ER once and to PPX IR three times a day
453475|NCT00479401|E2|Reported Event|Pramipexole Immediate Release (PPX IR)|PPX IR tablets taken three times a day
453476|NCT00479401|E1|Reported Event|Pramipexole Extended Release (PPX ER)|PPX ER tablets taken once in the morning
453477|NCT00479388|B3|Baseline|Total|Total of all reporting groups
453478|NCT00479388|B2|Baseline|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453479|NCT00479388|B1|Baseline|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453480|NCT00479388|P2|Participant Flow|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453481|NCT00479388|P1|Participant Flow|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453482|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453483|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453484|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453485|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453486|NCT00479388|O2|Outcome|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453487|NCT00479388|O1|Outcome|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453488|NCT00479388|E2|Reported Event|Run-in Statin Dose Doubled|Stable dose of simvastatin or atorvastatin (20mg to 40mg) for 12 weeks.
453489|NCT00479388|E1|Reported Event|ER Niacin/Laropiprant + Run-in Statin|One tablet of ER niacin/ laropiprant (1g) + one tablet of the run-in statin dose, titrating up to ER niacin/laropiprant (2g) at Week 4 for an additional 8 weeks, with no adjustments to the run-in statin dose.
453490|NCT00479336|B5|Baseline|Total|Total of all reporting groups
453491|NCT00479336|B4|Baseline|OPC-41061 30 mg|30 mg, 1 tablet a day
453492|NCT00479336|B3|Baseline|OPC-41061 15 mg|15 mg, 1 tablet a day
453493|NCT00479336|B2|Baseline|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
453494|NCT00479336|B1|Baseline|Placebo|Placebo, 1 tablet a day
453495|NCT00479336|P4|Participant Flow|OPC-41061 30 mg|30 mg, 1 tablet a day
453496|NCT00479336|P3|Participant Flow|OPC-41061 15 mg|15 mg, 1 tablet a day
453497|NCT00479336|P2|Participant Flow|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
453498|NCT00479336|P1|Participant Flow|Placebo|Placebo, 1 tablet a day
453499|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
453500|NCT00479336|O3|Outcome|OPC-41061 15 mg|15 mg, 1 tablet a day
453501|NCT00479336|O2|Outcome|OPC-41061 7.5 mg|7.5 mg, 1 tablet a day
453502|NCT00479336|O1|Outcome|Placebo|Placebo, 1 tablet a day
453503|NCT00479336|O4|Outcome|OPC-41061 30 mg|30 mg, 1 tablet a day
453512|NCT00479258|B2|Baseline|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
453513|NCT00479258|B1|Baseline|Inhaled Insulin (Exubera)|No subjects received study medication.
453514|NCT00479258|P2|Participant Flow|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
453515|NCT00479258|P1|Participant Flow|Inhaled Insulin (Exubera)|No subjects received study medication.
453516|NCT00479258|O2|Outcome|Subcutaneous Insulin (Subject's Prescribed)|No subjects received study medication.
453517|NCT00479258|O1|Outcome|Inhaled Insulin (Exubera)|No subjects received study medication.
453518|NCT00479232|B3|Baseline|Total|Total of all reporting groups
453519|NCT00479232|B2|Baseline|Vorinostat + Decitabine, Sequential|(sequential) Vorinostat 400 mg capsules once daily given 7, 10 or 14 days in 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
453520|NCT00479232|B1|Baseline|Vorinostat + Decitabine, Concurrent|(concurrent) Vorinostat 400 mg capsules once daily given 7 days, 14 days with 8 day break after first 7 days or 14 days without break, out of 28 day cycles along with decitabine IV 20 mg/m^2 daily for 5 days in each 28 day cycle. Up to 24 months of treatment.
453521|NCT00479232|P6|Participant Flow|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453522|NCT00479232|P5|Participant Flow|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453523|NCT00479232|P4|Participant Flow|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given qd on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453524|NCT00479232|P3|Participant Flow|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453525|NCT00479232|P2|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given qd on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453526|NCT00479232|P1|Participant Flow|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily (qd) on Days 1 to 7 in a 28 day cycle, along with decitabine intravenous (IV) 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453527|NCT00479232|O2|Outcome|Untreated AML or Intermediate, Sequential|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~sequentially."
453528|NCT00479232|O1|Outcome|Untreated AML or Intermediate, Concurrent|"Participants with Untreated AML or Intermediate-High~Risk MDS who were treated with vorinostat and Decitabine~concurrently."
453529|NCT00479232|O2|Outcome|Refractory or Relapsed AML, Sequential|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine sequentially.
453530|NCT00479232|O1|Outcome|Refractory or Relapsed AML, Concurrent|Participants with Refractory or Relapsed AML who were treated with vorinostat and Decitabine concurrently.
453531|NCT00479232|O6|Outcome|Sequential, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453532|NCT00479232|O5|Outcome|Sequential, Vorinostat 400mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453533|NCT00479232|O4|Outcome|Sequential, Vorinostat 400mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453534|NCT00479232|O3|Outcome|Concurrent, Vorinostat 400mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453535|NCT00479232|O2|Outcome|Concurrent, Vorinostat 400mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453536|NCT00479232|O1|Outcome|Concurrent, Vorinostat 400mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453537|NCT00479232|E6|Reported Event|Sequential,Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(sequential) orinostat 400 mg capsules given once daily on Days 6 to 19 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453538|NCT00479232|E5|Reported Event|Sequential, Vorinostat 400 mg qd x 10d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 15 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453539|NCT00479232|E4|Reported Event|Sequential, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(sequential) vorinostat 400 mg capsules given once daily on Days 6 to 12 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453540|NCT00479232|E3|Reported Event|Concurrent, Vorinostat 400 mg qd x 14d/4wk + Decitabine (MTD)|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 14 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453541|NCT00479232|E2|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/2wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 and Days 15 to 21 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453589|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453832|NCT00477269|O1|Outcome|STI571|STI571
453542|NCT00479232|E1|Reported Event|Concurrent, Vorinostat 400 mg qd x 7d/4wk + Decitabine|(concurrent) vorinostat 400 mg capsules given once daily on Days 1 to 7 in a 28 day cycle, along with decitabine IV 20mg/m^2 daily for 5 days in each 28 day cycle, up to 24 months of treatment.
453543|NCT00479154|B3|Baseline|Total|Total of all reporting groups
453544|NCT00479154|B2|Baseline|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
453545|NCT00479154|B1|Baseline|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
453546|NCT00479154|P2|Participant Flow|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
453547|NCT00479154|P1|Participant Flow|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
453548|NCT00479154|O2|Outcome|Botulinum Toxin|Injection of Botulinum Toxin (90 mU per leg).
453549|NCT00479154|O1|Outcome|Placebo|Injection into set of leg muscles with Placebo.
453550|NCT00479154|E2|Reported Event|Botulinum Toxin Then Placebo|Injection of Botulinum Toxin (90 mU per leg) followed by crossover to placebo at week 6.
453551|NCT00479154|E1|Reported Event|Placebo Then Botulinum Toxin|Injection into set of leg muscles with Placebo followed by crossover to Botulinum Toxin (90 mU per leg) at week 6.
453552|NCT00479089|B3|Baseline|Total|Total of all reporting groups
453553|NCT00479089|B2|Baseline|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453554|NCT00479089|B1|Baseline|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453555|NCT00479089|P2|Participant Flow|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453556|NCT00479089|P1|Participant Flow|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453557|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453558|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453559|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453560|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453561|NCT00479089|O2|Outcome|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453562|NCT00479089|O1|Outcome|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453563|NCT00479089|E2|Reported Event|Weekly Docetaxel + ZD1839|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy. ZD1839 250 mg by mouth daily, without break.
453564|NCT00479089|E1|Reported Event|Weekly Docetaxel|Docetaxel 25 mg/m^2 IV over 30 minutes for 4 weeks with premedication with Dexamethasone, followed by 2 weeks off therapy.
453565|NCT00479037|B3|Baseline|Total|Total of all reporting groups
453566|NCT00479037|B2|Baseline|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453567|NCT00479037|B1|Baseline|PTH(1-84)|Once daily subcutaneous injection
453568|NCT00479037|P2|Participant Flow|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453569|NCT00479037|P1|Participant Flow|PTH(1-84)|Once daily subcutaneous injection
453570|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453571|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
453572|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453573|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
453574|NCT00479037|O2|Outcome|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453575|NCT00479037|O1|Outcome|PTH(1-84)|Once daily subcutaneous injection
453576|NCT00479037|E2|Reported Event|Strontium Ranelate|One sachet (2 g) per day, suspended in water
453577|NCT00479037|E1|Reported Event|PTH(1-84)|Once daily subcutaneous injection
453578|NCT00478881|B3|Baseline|Total|Total of all reporting groups
453579|NCT00478881|B2|Baseline|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453580|NCT00478881|B1|Baseline|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453581|NCT00478881|P2|Participant Flow|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453582|NCT00478881|P1|Participant Flow|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453583|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453584|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453585|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453586|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453587|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453588|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453833|NCT00477269|O2|Outcome|Placebo|Placebo
453590|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453591|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453592|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453593|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453594|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453595|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453596|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453597|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453598|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453599|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453600|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453601|NCT00478881|O2|Outcome|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453602|NCT00478881|O1|Outcome|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453603|NCT00478881|E2|Reported Event|Placebo|vardenafil hydrochloride-matching film-coated tablets BID for oral intake for 6 weeks
453604|NCT00478881|E1|Reported Event|Vardenafil HCl (Levitra, BAY38-9456)|vardenafil hydrochloride 10 mg film-coated tablets twice daily (BID) for oral (by mouth) intake for 6 weeks
453605|NCT00478777|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453606|NCT00478777|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453607|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453608|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453609|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453610|NCT00478777|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453611|NCT00478777|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), dexamethasone was to be reduced to 40 mg QD for Days 1-4 of each 28 day-cycle.
453612|NCT00478673|B1|Baseline|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
453613|NCT00478673|P1|Participant Flow|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
453614|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
453669|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453670|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453615|NCT00478673|O1|Outcome|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
453616|NCT00478673|E1|Reported Event|NexStent Carotid Stent System|Subjects in this arm had carotid artery disease treated with the NexStent Carotid Stent System used in conjunction with the FilterWire EZ Embolic Protection System. The NexStent Carotid Stent is a rolled metal mesh sheet constrained in a sheath. The stent is inserted through the groin and is opened in the blocked carotid artery. The FilterWire EZ Embolic Protection System is a temporary filtration system used to contain and remove embolic material that may be released during the stenting procedure.
453617|NCT00478647|B1|Baseline|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453618|NCT00478647|P1|Participant Flow|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453619|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453620|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453621|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453622|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453623|NCT00478647|O1|Outcome|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453624|NCT00478647|E1|Reported Event|GA-GCB (Velaglucerase Alfa)|15-60 U/kg, every other week via intravenous infusion
453625|NCT00478608|B1|Baseline|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453626|NCT00478608|P1|Participant Flow|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453627|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453628|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453629|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453671|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453672|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453673|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453630|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453631|NCT00478608|O1|Outcome|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453632|NCT00478608|E1|Reported Event|Sirolimus (SRL)|"Patients initially received SRL, Cyclosporine (CsA) and Corticosteroids. After 2-4 months following transplantation, CsA was progressively withdrawn.~On Day 1 (within 48 hours after transplantation) SRL was initiated (6 mg loading dose). For Day 2 through CsA withdrawal (w/d), SRL dose was 2mg/day, with adjustment to maintain a target trough blood level of 5-15 ng/ml. During CsA w/d through month 6, SRL dose adjusted to a trough level of 15-30 ng/ml; and for months 7-12, a trough level of 12-24 ng/ml.~CsA initiated before or within 48 hours after transplantation at a dose to attain a trough level of 200-400 ng/ml. From month 1 to time of CsA w/d, CsA dose was adjusted to maintain a trough level of 150-300 ng/ml. At 2 to 4 months after transplantation, CsA was withdrawn over 4-8 weeks.~Corticosteroids were initiated within 24 hours before or after transplantation and tapered to ≥ 5 mg/day of prednisone by the end of week 13. W/d of corticosteroids was prohibited."
453633|NCT00478569|B1|Baseline|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
453634|NCT00478569|P1|Participant Flow|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
453635|NCT00478569|O5|Outcome|24 Months|
453636|NCT00478569|O4|Outcome|18 Months|
453637|NCT00478569|O3|Outcome|12 Months|
453638|NCT00478569|O2|Outcome|6 Months|
453639|NCT00478569|O1|Outcome|3 Months|
453640|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
453641|NCT00478569|O4|Outcome|24 Months|
453642|NCT00478569|O3|Outcome|18 Months|
453643|NCT00478569|O2|Outcome|12 Months|
453644|NCT00478569|O1|Outcome|3 Months|
453645|NCT00478569|O1|Outcome|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
453646|NCT00478569|E1|Reported Event|Parathyroid Hormone (PTH) (1-84)|PTH(1-84) was prescribed in accordance with the terms of the marketing authorization. Participants were observed for 24 months.
453647|NCT00478556|B3|Baseline|Total|Total of all reporting groups
453648|NCT00478556|B2|Baseline|Omnipaque|Oral Omnipaque prior to CT
453649|NCT00478556|B1|Baseline|Gastroview|Oral Gastroview prior to CT
453650|NCT00478556|P2|Participant Flow|Omnipaque|Oral Omnipaque prior to CT
453651|NCT00478556|P1|Participant Flow|Gastroview|Oral Gastroview prior to CT
453652|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
453653|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
453654|NCT00478556|O2|Outcome|Omnipaque|Oral Omnipaque prior to CT
453655|NCT00478556|O1|Outcome|Gastroview|Oral Gastroview prior to CT
453656|NCT00478556|E2|Reported Event|Omnipaque|Oral Omnipaque prior to CT
453657|NCT00478556|E1|Reported Event|Gastroview|Oral Gastroview prior to CT
453658|NCT00478257|B3|Baseline|Total|Total of all reporting groups
453659|NCT00478257|B2|Baseline|Effect of Red Light|effect of red light on fatigue in women with breast cancer
453660|NCT00478257|B1|Baseline|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
453661|NCT00478257|P2|Participant Flow|Effect of Red Light|effect of red light on fatigue in women with breast cancer
453662|NCT00478257|P1|Participant Flow|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
453663|NCT00478257|O2|Outcome|Effect of Red Light|effect of red light on fatigue in women with breast cancer
453664|NCT00478257|O1|Outcome|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
453665|NCT00478257|E2|Reported Event|Effect of Red Light|effect of red light on fatigue in women with breast cancer
453666|NCT00478257|E1|Reported Event|Effect of Bright Light|Effect of bright light on fatigue in women with breast cancer
453667|NCT00478244|B1|Baseline|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
453668|NCT00478244|P1|Participant Flow|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
453674|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453675|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453676|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453677|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453678|NCT00478244|O1|Outcome|Evaluable Patients|Includes only patients that received transplant (one patient died prior to transplant).
453679|NCT00478244|E1|Reported Event|Epidermolysis Bullosa (EB) Patients|Epidermolysis bullosa patients enrolled for treatment with chemotherapy (Busulfan 0.8 or 1.1 mg/kg Days 6-9 before transplant; Fludarabine 25 mg/m^2 Days 3-5 before transplant; Cyclophosphamide 50 mg/kg Days 2-5 before transplant) and stem cell infusion (Day 0) followed by donor epidermal transplant .
453680|NCT00478231|B1|Baseline|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453681|NCT00478231|P1|Participant Flow|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453682|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453683|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453684|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453685|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453686|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453687|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453688|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453689|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453690|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453691|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453692|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453693|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453694|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453695|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453696|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453697|NCT00478231|O1|Outcome|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453698|NCT00478231|E1|Reported Event|Maraviroc|Maraviroc tablet 150 to 600 milligrams (mg) twice daily (BID), dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care.
453699|NCT00478218|B3|Baseline|Total|Total of all reporting groups
453700|NCT00478218|B2|Baseline|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453701|NCT00478218|B1|Baseline|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453702|NCT00478218|P2|Participant Flow|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453703|NCT00478218|P1|Participant Flow|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453755|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453704|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453705|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453706|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453707|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453708|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453709|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453710|NCT00478218|O2|Outcome|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453711|NCT00478218|O1|Outcome|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453712|NCT00478218|E2|Reported Event|LCD (Cyclophosphamide 300 mg)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453713|NCT00478218|E1|Reported Event|LCD (Cyclophosphamide 300 mg/m^2)|Lenalidomide 25 mg PI days 1-21 Cyclophosphamide 300 mg/m^2 PO days 1, 8, 15 Dexamethasone 40 mg PI days 1, 8, 15, 22
453714|NCT00478205|B3|Baseline|Total|Total of all reporting groups
453715|NCT00478205|B2|Baseline|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453716|NCT00478205|B1|Baseline|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453717|NCT00478205|P2|Participant Flow|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453718|NCT00478205|P1|Participant Flow|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453719|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453720|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453721|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453722|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453723|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453724|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453725|NCT00478205|O2|Outcome|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453726|NCT00478205|O1|Outcome|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453727|NCT00478205|E2|Reported Event|Donepezil IR 10 mg|Donepezil immediate release (IR) 10 mg in combination with placebo corresponding to donepezil SR 23 mg; dosing continued for a 24-week treatment period.
453728|NCT00478205|E1|Reported Event|Donepezil SR 23 mg|Donepezil sustained release (SR) 23 mg in combination with placebo corresponding to donepezil IR 10 mg ; dosing continued for a 24-week treatment period.
453729|NCT00478192|B4|Baseline|Total|Total of all reporting groups
453730|NCT00478192|B3|Baseline|Regimen 3 Placebo|
453731|NCT00478192|B2|Baseline|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453732|NCT00478192|B1|Baseline|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453733|NCT00478192|P3|Participant Flow|Regimen 3 Placebo|
453734|NCT00478192|P2|Participant Flow|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453735|NCT00478192|P1|Participant Flow|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453736|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453737|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453738|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453739|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453740|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453741|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453742|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453743|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453744|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453745|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453746|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453747|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453748|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453749|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453750|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453751|NCT00478192|O1|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453752|NCT00478192|O3|Outcome|Regimen 3 Placebo|
453753|NCT00478192|O2|Outcome|Regimen 2 Conivaptan BID|20 mg conivaptan two times a day
453754|NCT00478192|O1|Outcome|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453760|NCT00478192|E1|Reported Event|Regimen 1 Conivaptan QD|20 mg conivaptan once a day
453761|NCT00478140|B1|Baseline|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
453762|NCT00478140|P1|Participant Flow|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
453763|NCT00478140|O1|Outcome|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
453764|NCT00478140|E1|Reported Event|Trastuzumab|Trastuzumab loading dose 8 mg/kg intravenous (IV) over 30-90 minutes on day 1 and subsequent maintenance doses of 6 mg/kg over 90 minutes then every 30 minutes starting at the third dose. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
453765|NCT00477334|B3|Baseline|Total|Total of all reporting groups
453766|NCT00477334|B2|Baseline|Placebo Comparator|Placebo twice a day for one day for treatment.
453767|NCT00477334|B1|Baseline|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453768|NCT00477334|P2|Participant Flow|Placebo Comparator|Placebo twice a day for one day for treatment.
453769|NCT00477334|P1|Participant Flow|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453770|NCT00477334|O4|Outcome|Grade 4 Toxicity|
453771|NCT00477334|O3|Outcome|Grade 3 Toxicity|
453772|NCT00477334|O2|Outcome|Grade 2 Toxicity|
453773|NCT00477334|O1|Outcome|Grade 1 Toxicity|
453774|NCT00477334|O4|Outcome|Grade 4 Toxicity|
453775|NCT00477334|O3|Outcome|Grade 3 Toxicity|
453776|NCT00477334|O2|Outcome|Grade 2 Toxicity|
453777|NCT00477334|O1|Outcome|Grade 1 Toxicity|
453778|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453779|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453780|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453781|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453782|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453783|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453784|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453785|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453786|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453787|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453788|NCT00477334|O2|Outcome|Placebo Comparator|Placebo twice a day for one day for treatment.
453789|NCT00477334|O1|Outcome|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453790|NCT00477334|E2|Reported Event|Placebo Comparator|Placebo twice a day for one day for treatment.
453791|NCT00477334|E1|Reported Event|Famciclovir 1000 mg|Famciclovir 1000 mg; twice a day for one day for treatment.
453792|NCT00477295|B3|Baseline|Total|Total of all reporting groups
453793|NCT00477295|B2|Baseline|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453794|NCT00477295|B1|Baseline|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453795|NCT00477295|P2|Participant Flow|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453796|NCT00477295|P1|Participant Flow|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453797|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453834|NCT00477269|O1|Outcome|STI571|STI571
453798|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453799|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453800|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453801|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453802|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453803|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453804|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453805|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453806|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
453807|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453808|NCT00477295|O1|Outcome|Zonisamide|"The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily.~During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP."
453809|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453835|NCT00477269|O2|Outcome|Placebo|Placebo
453836|NCT00477269|O1|Outcome|STI571|STI571
453837|NCT00477269|O2|Outcome|Placebo|Placebo
453810|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453811|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453812|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453813|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453814|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453815|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453816|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453817|NCT00477295|O2|Outcome|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453818|NCT00477295|O1|Outcome|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP(the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453819|NCT00477295|E2|Reported Event|Carbamazepine|The starting dose in this arm was carbamazepine 200mg daily. The dose during the Titration Period (4 weeks) ranged from 200 to 400mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 600 to 1200mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453820|NCT00477295|E1|Reported Event|Zonisamide|The starting dose in this arm was zonisamide 100mg daily. The dose during the Titration Period (4 weeks) ranged from 100 to 200mg daily. During the Flexible Dosing Period (FDP), the subjects were given doses ranging from 300 to 500mg daily or if they could not tolerate that dose, were allowed one down-titration or were withdrawn. If the subjects remained seizure-free for 26 weeks by the end of FDP (the subject was allowed 3 chances to achieve this), they entered the Maintenance Period (26 weeks), where they remained on the same dose they were taking at the end of the FDP.
453821|NCT00477269|B3|Baseline|Total|Total of all reporting groups
453822|NCT00477269|B2|Baseline|Placebo|Placebo
453823|NCT00477269|B1|Baseline|STI571|STI571
453824|NCT00477269|P3|Participant Flow|All Patients|Open label extension
453825|NCT00477269|P2|Participant Flow|Placebo|Placebo
453826|NCT00477269|P1|Participant Flow|STI571|STI571
453827|NCT00477269|O2|Outcome|Placebo|Placebo
453828|NCT00477269|O1|Outcome|STI571|STI571
453829|NCT00477269|O2|Outcome|Placebo|Placebo
453830|NCT00477269|O1|Outcome|STI571|STI571
453831|NCT00477269|O2|Outcome|Placebo|Placebo
453857|NCT00477269|O2|Outcome|Placebo|Placebo
453858|NCT00477269|O1|Outcome|STI571|STI571
453859|NCT00477269|O2|Outcome|Placebo|Placebo
453860|NCT00477269|O1|Outcome|STI571|STI571
453861|NCT00477269|O2|Outcome|Placebo|Placebo
453862|NCT00477269|O1|Outcome|STI571|STI571
453863|NCT00477269|O2|Outcome|Placebo|Placebo
453864|NCT00477269|O1|Outcome|STI571|STI571
453865|NCT00477269|O2|Outcome|Placebo|Placebo
453866|NCT00477269|O1|Outcome|STI571|STI571
453867|NCT00477269|O2|Outcome|Placebo|Placebo
453868|NCT00477269|O1|Outcome|STI571|STI571
453869|NCT00477269|O2|Outcome|Placebo|Placebo
453870|NCT00477269|O1|Outcome|STI571|STI571
453871|NCT00477269|O1|Outcome|All Patients|Open label extension
453872|NCT00477269|O2|Outcome|Placebo|Placebo
453873|NCT00477269|O1|Outcome|STI571|STI571
453874|NCT00477269|E3|Reported Event|Extension - STI571|Extension - STI571
453875|NCT00477269|E2|Reported Event|Core - Placebo|Core - Placebo
453876|NCT00477269|E1|Reported Event|Core - STI571|Core - STI571
453877|NCT00477230|B3|Baseline|Total|Total of all reporting groups
453878|NCT00477230|B2|Baseline|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
453879|NCT00477230|B1|Baseline|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
453880|NCT00477230|P2|Participant Flow|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
453881|NCT00477230|P1|Participant Flow|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
453882|NCT00477230|O2|Outcome|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
453883|NCT00477230|O1|Outcome|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
453884|NCT00477230|E2|Reported Event|Standard Anti-arrhythmic Drug Therapy|Medication as prescribed by physician.
453885|NCT00477230|E1|Reported Event|Single Ablation Procedure With Endoscopic Ablation System|Single ablation procedure with Endoscopic Ablation System
453886|NCT00478036|B4|Baseline|Total|Total of all reporting groups
453887|NCT00478036|B3|Baseline|Predforte Group|Used predforte eye drops
453888|NCT00478036|B2|Baseline|Acular Group|Used acular LS
453889|NCT00478036|B1|Baseline|Placebo Group|Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days
453890|NCT00478036|P3|Participant Flow|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
453891|NCT00478036|P2|Participant Flow|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
453892|NCT00478036|P1|Participant Flow|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
453893|NCT00478036|O3|Outcome|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
453894|NCT00478036|O2|Outcome|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
453895|NCT00478036|O1|Outcome|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
453896|NCT00478036|E3|Reported Event|Refresh Tears|"Refresh Tears - 1 drop in treated eye, 4 times a day, for 4 days~Refresh Tears: Placebo"
453897|NCT00478036|E2|Reported Event|Pred Forte|"Pred Forte - 1 drop in treated eye, 4 times a day, for 4 days~Pred Forte: Details covered in arm description"
453898|NCT00478036|E1|Reported Event|Acular LS|"Acular LS - 1 drop in treated eye, 4 times a day, for 4 days~Acular LS: Details covered in arm description"
453899|NCT00478023|B6|Baseline|Total|Total of all reporting groups
453900|NCT00478023|B5|Baseline|Placebo|Matched Placebo 4 to 6 hourly
453901|NCT00478023|B4|Baseline|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
453902|NCT00478023|B3|Baseline|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
453903|NCT00478023|B2|Baseline|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
453904|NCT00478023|B1|Baseline|Morphine|Morphine IR 20mg 4-6 hourly
453905|NCT00478023|P5|Participant Flow|Placebo|Matched Placebo 4 to 6 hourly
453906|NCT00478023|P4|Participant Flow|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
453907|NCT00478023|P3|Participant Flow|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
453908|NCT00478023|P2|Participant Flow|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
453909|NCT00478023|P1|Participant Flow|Morphine|Morphine IR 20mg 4-6 hourly
453910|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
453911|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
453912|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
453913|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
453914|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
453915|NCT00478023|O5|Outcome|Placebo|Matched Placebo 4 to 6 hourly
453916|NCT00478023|O4|Outcome|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
453917|NCT00478023|O3|Outcome|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
453918|NCT00478023|O2|Outcome|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
453919|NCT00478023|O1|Outcome|Morphine|Morphine IR 20mg 4-6 hourly
453920|NCT00478023|E5|Reported Event|Placebo|Matched Placebo 4 to 6 hourly
453921|NCT00478023|E4|Reported Event|CG5503 100mg|CG5503 IR 100mg 4 to 6 hourly
453922|NCT00478023|E3|Reported Event|CG5503 75mg|CG5503 IR 75mg 4 to 6 hourly
453923|NCT00478023|E2|Reported Event|CG5503 50mg|CG5503 IR 50mg 4 to 6 hourly
453924|NCT00478023|E1|Reported Event|Morphine|Morphine IR 20mg 4-6 hourly
453925|NCT00477971|B3|Baseline|Total|Total of all reporting groups
453926|NCT00477971|B2|Baseline|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453927|NCT00477971|B1|Baseline|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453928|NCT00477971|P2|Participant Flow|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453929|NCT00477971|P1|Participant Flow|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453930|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453931|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453932|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453933|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453934|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453935|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453936|NCT00477971|O2|Outcome|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453937|NCT00477971|O1|Outcome|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453938|NCT00477971|E2|Reported Event|High-Dose Melphalan + Autologous HSC|Patients receive filgrastim (G-CSF) 10 mg/kg/day on days -7 to -3 and undergo autologous hematopoietic stem cell (HSC) collection. Patients receive high-dose melphalan 140 mg/m^2 IV for low risk or 200 mg/m^2 IV for high risk patients over 1 hour on days -2 and -1 and undergo autologous HSC transplantation on day 0.
453939|NCT00477971|E1|Reported Event|Low-Dose Melphalan|Patients receive low-dose melphalan 20 mg/m^2 IV over 15-30 minutes on day 1 or 0.12 mg/kg tablet orally once daily on days 1-7 and dexamethasone 40 mg orally on days 1-4 and 22-25. Treatment repeats every 6 weeks for 10 courses. (Study treatment beyond one year is not allowed.)
453940|NCT00477750|B1|Baseline|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
453941|NCT00477750|P1|Participant Flow|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
453942|NCT00477750|O1|Outcome|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression > > Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression >~> Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
453943|NCT00477750|E1|Reported Event|Treatment (Lenalidomide, Melphalan, Prednisone)|"Intervention: Drug: lenalidomide 10 mg orally days 1-21 every 28 days until progression~Intervention: Drug: melphalan 5mg/m^2 orally days 1-4 every 28 days until progression~Intervention: Drug: prednisone 60mg/m^2, orally days 1-4 every 28 days until progression"
453944|NCT00477685|B1|Baseline|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
453945|NCT00477685|P1|Participant Flow|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
453946|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
453947|NCT00477685|O1|Outcome|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
453948|NCT00477685|E1|Reported Event|OculusGen Collagen Matrix|OculusGen Biodegradable Collagen Matrix Implant in Trabeculectomy.
453949|NCT00477672|B4|Baseline|Total|Total of all reporting groups
453950|NCT00477672|B3|Baseline|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
453951|NCT00477672|B2|Baseline|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
453952|NCT00477672|B1|Baseline|Placebo|Placebo tablet, once daily by mouth, 6 weeks
453953|NCT00477672|P3|Participant Flow|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
454277|NCT00476476|B3|Baseline|Total|Total of all reporting groups
453954|NCT00477672|P2|Participant Flow|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
453955|NCT00477672|P1|Participant Flow|Placebo|Placebo tablet, once daily by mouth, 6 weeks
453956|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
453957|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
453958|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
453959|NCT00477672|O3|Outcome|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
453960|NCT00477672|O2|Outcome|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
453961|NCT00477672|O1|Outcome|Placebo|Placebo tablet, once daily by mouth, 6 weeks
453962|NCT00477672|E3|Reported Event|Pimavanserin 40 mg|Pimavanserin tartrate (ACP-103) 40 mg, tablet, once daily by mouth, 6 weeks
453963|NCT00477672|E2|Reported Event|Pimavanserin 10 mg|Pimavanserin tartrate (ACP-103) 10 mg, tablet, once daily by mouth, 6 weeks
453964|NCT00477672|E1|Reported Event|Placebo|Placebo tablet, once daily by mouth, 6 weeks
453965|NCT00477633|B1|Baseline|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453966|NCT00477633|P1|Participant Flow|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453967|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453968|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453969|NCT00477633|O1|Outcome|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453970|NCT00477633|E1|Reported Event|Norethindrone/Ethinyl Estradiol Tablets|1 tablet daily 0.8mg norethindrone(NE)/ 0.025 mg ethinyl estradiol (EE) tablets for 24 days of 28 day cycle followed by 4 days of placebo
453971|NCT00477607|B3|Baseline|Total|Total of all reporting groups
453972|NCT00477607|B2|Baseline|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
453973|NCT00477607|B1|Baseline|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
453974|NCT00477607|P2|Participant Flow|Placebo|"Receiving placebo during cisplatin treatment~Placebo supplements (1200mg once a day) were administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
453975|NCT00477607|P1|Participant Flow|Alpha-lipoic Acid|"Receiving alpha-lipoic acid during cisplatin treatment.~alpha-lipoic acid : Supplements (1200mg once a day) was administered to each patient prior to first cisplatin treatment and continued until 3 months after last treatment."
453976|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
453977|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
453978|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
453979|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
453980|NCT00477607|O2|Outcome|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
454040|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453981|NCT00477607|O1|Outcome|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
453982|NCT00477607|E2|Reported Event|Arm 2|"Receiving placebo during cisplatin treatment~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress."
453983|NCT00477607|E1|Reported Event|Arm 1|"Receiving alpha-lipoic acid during cisplatin treatment.~laboratory biomarker analysis : Plasma concentrations of Malondialdehyde (MDA) will be measures as an indicator of oxidative stress.~alpha-lipoic acid : Supplements (1200mg once a day) or placebo will be administered to each patient prior to first cisplatin treatment and continue until 3 months after last treatment.~Audiology : otoscopy, immittance screening, noise exposure questionnaire and individualized behavioral pure-tone in the convention and high-frequency ranges."
453984|NCT00477594|B3|Baseline|Total|Total of all reporting groups
453985|NCT00477594|B2|Baseline|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453986|NCT00477594|B1|Baseline|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453987|NCT00477594|P2|Participant Flow|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453988|NCT00477594|P1|Participant Flow|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453989|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453990|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453991|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453992|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453993|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453994|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453995|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453996|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453997|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
453998|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
453999|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454000|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454001|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454002|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454003|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454004|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454005|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454006|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454007|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454008|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454009|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454010|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454011|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454012|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454013|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454014|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454015|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454016|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454017|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454018|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454019|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454020|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454021|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454022|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454023|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454024|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454025|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454026|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454027|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454028|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454029|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454030|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454031|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454032|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454033|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454034|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454035|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454036|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454037|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454038|NCT00477594|O1|Outcome|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454039|NCT00477594|O2|Outcome|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454041|NCT00477594|E2|Reported Event|Mipomersen 200 mg Every Other Week|Participants received 200 mg mipomersen every other week by subcutaneous injection, for up to 3 years. Participants could receive mipomersen 200 mg once a week at the Investigator’s discretion after the first 52 weeks of the treatment period.
454042|NCT00477594|E1|Reported Event|Mipomersen 200 mg Per Week|Participants received 200 mg mipomersen once a week by subcutaneous injection, for up to 3 years.
454043|NCT00477490|B6|Baseline|Total|Total of all reporting groups
454044|NCT00477490|B5|Baseline|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454045|NCT00477490|B4|Baseline|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454046|NCT00477490|B3|Baseline|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454047|NCT00477490|B2|Baseline|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454048|NCT00477490|B1|Baseline|Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454049|NCT00477490|P9|Participant Flow|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454050|NCT00477490|P8|Participant Flow|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
454051|NCT00477490|P7|Participant Flow|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
454052|NCT00477490|P6|Participant Flow|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
454053|NCT00477490|P5|Participant Flow|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454054|NCT00477490|P4|Participant Flow|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454055|NCT00477490|P3|Participant Flow|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454056|NCT00477490|P2|Participant Flow|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454057|NCT00477490|P1|Participant Flow|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454058|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454059|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
454060|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
454061|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
454062|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454063|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454064|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454065|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454066|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454067|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454068|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454069|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454070|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454071|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454072|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454073|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454074|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454075|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454076|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454077|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454078|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454079|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454080|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454081|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454082|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454083|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454084|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454085|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454086|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454087|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454088|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454089|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454090|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454207|NCT00476957|E1|Reported Event|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
454091|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454092|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454093|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454094|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454095|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454096|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454097|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454098|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454099|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454100|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454101|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454102|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
454103|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
454104|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
454105|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454106|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454107|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454108|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454109|NCT00477490|O8|Outcome|Placebo to 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454110|NCT00477490|O7|Outcome|Placebo to 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
454111|NCT00477490|O6|Outcome|Placebo to 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
454112|NCT00477490|O5|Outcome|Placebo to 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime.
454113|NCT00477490|O4|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454114|NCT00477490|O3|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454115|NCT00477490|O2|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454208|NCT00476827|B7|Baseline|Total|Total of all reporting groups
454116|NCT00477490|O1|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454117|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454118|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454119|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454120|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454121|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454122|NCT00477490|O5|Outcome|Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454123|NCT00477490|O4|Outcome|Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454124|NCT00477490|O3|Outcome|Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454125|NCT00477490|O2|Outcome|Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454126|NCT00477490|O1|Outcome|Placebo|Participants took a placebo 'melt' for 28 days to complete Part I of the study. In Part II, placebo patients were randomized to one of the other four treatment arms to receive active desmopressin melt for between 1-6 months (until the database for part 1 was locked and treatment was unblinded).
454127|NCT00477490|E13|Reported Event|Part II: Placebo to Desmopressin Melt 100 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 100 μg once daily about an hour before bedtime.
454128|NCT00477490|E12|Reported Event|Part II: Placebo to Desmopressin Melt 50 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 50 μg once daily about an hour before bedtime.
454129|NCT00477490|E11|Reported Event|Part II: Placebo to Desmopressin Melt 25 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 25 μg once daily about an hour before bedtime.
454130|NCT00477490|E10|Reported Event|Part II: Placebo to Desmopressin Melt 10 μg|Participants randomized to Placebo in study Part I were re-randomized to receive active desmopressin in Part II. These participants were randomized to receive desmopressin melt 10 μg once daily about an hour before bedtime
454131|NCT00477490|E9|Reported Event|Part II: Desmopressin Melt 100 μg|Participants who took desmopressin melt 100 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
454132|NCT00477490|E8|Reported Event|Part II: Desmopressin Melt 50 μg|Participants who took desmopressin melt 50 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
454133|NCT00477490|E7|Reported Event|Part II: Desmopressin Melt 25 μg|Participants who took desmopressin melt 25 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
454134|NCT00477490|E6|Reported Event|Part II: Desmopressin Melt 10 μg|Participants who took desmopressin melt 10 μg in Part I of the study continued on this dose in Part II which ran between Months 1-6 (until the database for Part I was locked and treatment was unblinded).
454135|NCT00477490|E5|Reported Event|Part I: Desmopressin Melt 100 μg|Participants took desmopressin melt 100 μg for 28 days to complete Part I of the study. Participants continued on this dose in study Part II for between 1-6 months (until the database for Part I was locked and treatment was unblinded).
454136|NCT00477490|E4|Reported Event|Part I: Desmopressin Melt 50 μg|Participants took desmopressin melt 50 μg for 28 days to complete Part I of the study.
454137|NCT00477490|E3|Reported Event|Part I: Desmopressin Melt 25 μg|Participants took desmopressin melt 25 μg for 28 days to complete Part I of the study.
454138|NCT00477490|E2|Reported Event|Part I: Desmopressin Melt 10 μg|Participants took desmopressin melt 10 μg for 28 days to complete Part I of the study.
454139|NCT00477490|E1|Reported Event|Part I: Placebo|Participants took a placebo ‘melt’ for 28 days to complete Part I of the study.
454140|NCT00477464|B1|Baseline|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
454141|NCT00477464|P1|Participant Flow|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
454142|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454143|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454144|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454145|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454146|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454147|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|
454148|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454149|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454150|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454151|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454152|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454153|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454154|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454155|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454156|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454157|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454158|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454159|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454160|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 mg once daily. Capecitabine was orally administered at 1000 mg/m^2 twice daily on the first day through the fourteenth day of each 21-day cycle.
454161|NCT00477464|O1|Outcome|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
454162|NCT00477464|E1|Reported Event|Lapatinib 1250 mg and Capecitabine 2000 mg/m^2|Participants took lapatinib and capecitabine. Lapatinib was orally administered at 1250 milligrams (mg) once daily. Capecitabine was orally administered at 1000 mg per square meter (mg/m^2) twice daily on the first day through the fourteenth day of each 21-day cycle.
454163|NCT00477386|B3|Baseline|Total|Total of all reporting groups
454164|NCT00477386|B2|Baseline|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454165|NCT00477386|B1|Baseline|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454166|NCT00477386|P2|Participant Flow|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454167|NCT00477386|P1|Participant Flow|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454168|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454169|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454170|NCT00477386|O1|Outcome|Phase II Dose Treatment|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454171|NCT00477386|O1|Outcome|Phase I Dose Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454172|NCT00477386|E2|Reported Event|Phase II|Decitabine at 10 mg/m2 will be given by IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454173|NCT00477386|E1|Reported Event|Phase I Dosing Finding|Decitabine at escalating dose levels will be given IV for 1 hour x 5 days followed by Carboplatin given IV for 30 minutes on Day 8 at a dose corresponding to an AUC of 5.
454174|NCT00477204|B3|Baseline|Total|Total of all reporting groups
454175|NCT00477204|B2|Baseline|Zocor|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
454176|NCT00477204|B1|Baseline|Vytorin|simvastatin, ezetimibe/simvastatin : simvastatin 20 mg daiy ezetimibe/simvastatin 10/20 mg daily placebo for each medication
454177|NCT00477204|P2|Participant Flow|Simvastatin|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
454178|NCT00477204|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
454179|NCT00477204|O2|Outcome|Zocor (Simvastatin)|"simvastatin: simvastatin 20 mg daily~placebo for each medication"
454180|NCT00477204|O1|Outcome|Vytorin (Ezetimibe/Simvastatin)|ezetimibe/simvastatin : ezetimibe/simvastatin 10/20 mg daily placebo for each medication
454181|NCT00477204|E2|Reported Event|Zocor [Simvastatin]|Zocor [simvastatin] 20 mg taken daily for 6 months to compare in a 2- arm design to Vytorin [simvastatin + ezetimibe].
454182|NCT00477204|E1|Reported Event|Vytorin (Simvastatin + Ezetimibe)|Vytorin [simvastatin + ezetimibe]20 mg taken daily for 6 months to compare in a 2- arm design to Zocor [simvastatin] .
454183|NCT00477191|B1|Baseline|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and then 50 mg once a week for 3 months."
454184|NCT00477191|P1|Participant Flow|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454185|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454186|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454187|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454188|NCT00477191|O1|Outcome|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454189|NCT00477191|E1|Reported Event|Etanercept|"Etanercept~Etanercept: TNF-alpha antagonist 50 mg twice a week x 3 mos and the 50 mg once a week for 3 months."
454190|NCT00477152|B1|Baseline|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454191|NCT00477152|P1|Participant Flow|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454192|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454193|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454194|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454195|NCT00477152|O1|Outcome|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454196|NCT00477152|E1|Reported Event|HYLENEX-augmented Subcutaneous (SC) Rehydration|Single 150 U subcutaneous (SC) HYLENEX dose administered immediately prior to start of SC infusion of rehydration fluid. Additional 150 U HYLENEX dose to be administered prior to any additional fluid infusion beyond 24 hours.
454197|NCT00476957|B3|Baseline|Total|Total of all reporting groups
454198|NCT00476957|B2|Baseline|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
454199|NCT00476957|B1|Baseline|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
454200|NCT00476957|P2|Participant Flow|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
454201|NCT00476957|P1|Participant Flow|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
454202|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
454203|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
454204|NCT00476957|O2|Outcome|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
454205|NCT00476957|O1|Outcome|E-ZES|"Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System~Stent : Stent implantation"
454206|NCT00476957|E2|Reported Event|C-SES|"Cordis Cypher® Sirolimus-eluting Coronary Stent~Stent : Stent implantation"
454209|NCT00476827|B6|Baseline|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454210|NCT00476827|B5|Baseline|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454211|NCT00476827|B4|Baseline|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454212|NCT00476827|B3|Baseline|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454213|NCT00476827|B2|Baseline|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454214|NCT00476827|B1|Baseline|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454215|NCT00476827|P6|Participant Flow|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454216|NCT00476827|P5|Participant Flow|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454217|NCT00476827|P4|Participant Flow|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454218|NCT00476827|P3|Participant Flow|Bevacizumab / Irinotecan (Camptosar®, CPT-11)|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454219|NCT00476827|P2|Participant Flow|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454220|NCT00476827|P1|Participant Flow|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454221|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454222|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454223|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454224|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454225|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454226|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454227|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454228|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454229|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454230|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454231|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454232|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454233|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454234|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454235|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454236|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454237|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454238|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454239|NCT00476827|O6|Outcome|Bevacizumab / Gemcitabine|Gemcitabine (difluorodeoxycytidine, dFdC) 1000 mg/m2 IV on days 1 and 8 in combination with avastin 15 mg/kg IV on day 1 of a 21-day treatment cycle.
454240|NCT00476827|O5|Outcome|Bevacizumab /Vinorelbine Tartrate|Vinorelbine Tartrate (Navelbine®) 25 mg/m² IV over 10 min days 1, 8 and 15 in combination with avastin 10 mg/kg IV on days 1 and 15 of a 28-day cycle.
454241|NCT00476827|O4|Outcome|Bevacizumab / Paclitaxel|Paclitaxel (Taxol)90 mg/m2 IV over 60-90 min days 1, 8, and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454242|NCT00476827|O3|Outcome|Bevacizumab / CPT-11|CPT-11 (Irinotecan, Camptosar) - Patients being treated with an enzyme inducing antiepileptic drug (EIAED) will receive 340 mg/m² IV; others will receive 125 mg/m² IV 90 min on days 1 and 15, in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454243|NCT00476827|O2|Outcome|Bevacizumab / Docetaxel|Docetaxel (taxotere) 35mg/m² IV over 60 min days 1, 8, and 15 in combination with avastin 10 mg/kg on days 1 and 15 of a 28-day cycle.
454244|NCT00476827|O1|Outcome|Bevacizumab / Capecitabine|Bevacizumab 15 mg/kg every 3 weeks in combination with Capecitabine (Xeloda), 2 weeks on and 1 week off on a every 3 week cycle.
454245|NCT00476827|E4|Reported Event|Avastin (Bevacizumab)/Navelbine (Vinorelbine Tartrate)|
454246|NCT00476827|E3|Reported Event|Avastin (Bevacizumab)/Gemzar(Gemcitabine,Difluorodeoxycytidine|
454247|NCT00476827|E2|Reported Event|Avastin (Bevacizumab) / Camptosar (CPT 11/ Irinotecan)|
454248|NCT00476827|E1|Reported Event|Avastin (Bevacizumab)/ Capecitabine (Xeloda)|
454249|NCT00476788|B1|Baseline|Omnipod Device|Patients will be placed on an Omnipod insulin pump
454250|NCT00476788|P1|Participant Flow|Omnipod Device|Patients will be placed on an Omnipod insulin pump
454251|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
454252|NCT00476788|O1|Outcome|Omnipod Device|Patients will be placed on an Omnipod insulin pump
454253|NCT00476788|E1|Reported Event|Omnipod Device|Patients will be placed on an Omnipod insulin pump
454254|NCT00476645|B1|Baseline|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454255|NCT00476645|P1|Participant Flow|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454256|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454257|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454258|NCT00476645|O1|Outcome|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454259|NCT00476645|E1|Reported Event|Fulvestrant 250 mg|IM fulvestrant (250 mg) day 1 & day 14 of 1st month, then monthly
454260|NCT00476593|B5|Baseline|Total|Total of all reporting groups
454261|NCT00476593|B4|Baseline|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
454262|NCT00476593|B3|Baseline|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
454263|NCT00476593|B2|Baseline|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
454264|NCT00476593|B1|Baseline|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
454265|NCT00476593|P4|Participant Flow|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
454266|NCT00476593|P3|Participant Flow|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
454267|NCT00476593|P2|Participant Flow|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
454268|NCT00476593|P1|Participant Flow|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
454269|NCT00476593|O4|Outcome|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
454270|NCT00476593|O3|Outcome|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
454271|NCT00476593|O2|Outcome|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
454272|NCT00476593|O1|Outcome|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
454273|NCT00476593|E4|Reported Event|Healthy Volunteers|Healthy volunteers recruited from students and staff at St Olavs University hospital and NTU went through an opthalmologic examination and OCT scans were taken of their both eyes. This groups was to serve as healthy controls and as matching normative data for patients
454274|NCT00476593|E3|Reported Event|Patients With Anterior Uveitis|Patients with anterior uveitis were recruited from the Department of Ophthalmology. They were treated for their uveitis and OCT scans of their both eyes were taken on follow up.
454275|NCT00476593|E2|Reported Event|B Dexamethasone|Benzalkonium-reserved Dexamethasone Sodium Phosphate 0.1% was applied in one consecutively assigned eye of healthy volunteers six times a day for three days, after which macular thickness was assessed in both subjects's eyes with the OCT.
454276|NCT00476593|E1|Reported Event|A Diclofenac|Preservative- free Diclofenac Na 0.1 % eye drops were applied in one consecutively assigned eye of healthy volunteers four times a day for three days, after which macular thichness was measured in both subjects' eyes with the OCT .
454278|NCT00476476|B2|Baseline|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
454279|NCT00476476|B1|Baseline|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
454280|NCT00476476|P2|Participant Flow|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
454281|NCT00476476|P1|Participant Flow|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
454282|NCT00476476|O2|Outcome|Erlotinib-Cohort 2|Patients rcvd oral erlotinib 150 mg/day. Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
454283|NCT00476476|O1|Outcome|Erlotinib-Cohort 1|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Two potential dose reductions were prescribed to 100 and 50 mg/day.
454284|NCT00476476|E1|Reported Event|Erlotinib|Patients rcvd oral erlotinib 150 mg/day. Cohort 1 pts would have at least 28 days and no more than 42 days of therapy in advance of definitive therapy (surgery or chemoradiation). Cohort 2 pts continued on therapy (28 days per cycle) until disease progression, unacceptable toxicity or withdrawal of consent. Two potential dose reductions were prescribed to 100 and 50 mg/day.
454285|NCT00476242|B3|Baseline|Total|Total of all reporting groups
454286|NCT00476242|B2|Baseline|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
454287|NCT00476242|B1|Baseline|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
454288|NCT00476242|P2|Participant Flow|Memantine and Vivitrol|Participants treated with memantine 40 mg/d capsules and Vivitrol.
454289|NCT00476242|P1|Participant Flow|Placebo and Vivitrol|Participants treated with placebo capsules and Vivitrol.
454290|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
454291|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
454292|NCT00476242|O2|Outcome|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
454293|NCT00476242|O1|Outcome|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
454294|NCT00476242|E2|Reported Event|Placebo and Vivitrol|"intramuscular injection of Vivitrol 380 mg and Placebo~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)"
454295|NCT00476242|E1|Reported Event|Memantine and Vivitrol|"intramuscular injection of Vivitrol 380 mg and 20 mg bid Memantine (PO)~Vivitrol: intramuscular injection of Vivitrol 380 mg for up to 6 months (six injections)~memantine: Memantine will be given in two divided doses, starting with the second day of the naltrexone induction, with the target doses of 40 mg/day (or the maximum tolerated dose), for a total of twelve weeks of medication treatment."
454296|NCT00476229|B1|Baseline|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
454297|NCT00476229|P1|Participant Flow|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
454298|NCT00476229|O1|Outcome|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
454299|NCT00476229|E1|Reported Event|Radiation + Chemotherapy + BSCT|Total Lymphoid Irradiation (2 times) at 80 cGy daily for five days + Thymoglobulin 1.5 mg/kg intravenous 5 days + Rituximab 375 mg/m^2 intravenous on 4 different days + Blood stem cell transplant (BSCT)
454300|NCT00476151|B3|Baseline|Total|Total of all reporting groups
454301|NCT00476151|B2|Baseline|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
454302|NCT00476151|B1|Baseline|Placebo Cream|vehicle cream applied twice daily for 4 weeks
454303|NCT00476151|P2|Participant Flow|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
454304|NCT00476151|P1|Participant Flow|Placebo Cream|vehicle cream applied twice daily for 4 weeks
454305|NCT00476151|O2|Outcome|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
454306|NCT00476151|O1|Outcome|Placebo Cream|vehicle cream applied twice daily for 4 weeks
454307|NCT00476151|E2|Reported Event|Amitriptyline 4% Ketamine 2% Cream|active topical cream applied twice daily for 4 weeks
454308|NCT00476151|E1|Reported Event|Placebo Cream|vehicle cream applied twice daily for 4 weeks
454309|NCT00476086|B1|Baseline|Oxaliplatin/ Gemcitabine Then Radiation|"Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.~on"
454310|NCT00476086|P1|Participant Flow|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
454311|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients received IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
454312|NCT00476086|O1|Outcome|Oxaliplatin/ Gemcitabine Then Radiation|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
454313|NCT00476086|E2|Reported Event|Radiation|On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
454314|NCT00476086|E1|Reported Event|Oxaliplatin/ Gemcitabine|Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted.
454315|NCT00476021|B3|Baseline|Total|Total of all reporting groups
454316|NCT00476021|B2|Baseline|Delayed IUD Insertion (6-8 Weeks After Delivery)|"delayed IUD insertion (6-8 weeks after delivery)~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
454317|NCT00476021|B1|Baseline|Immediate Postplacental IUD Insertion|"immediate postplacental IUD insertion~Levonorgestrel-releasing IUD (Mirena): levonorgestrel-releasing IUD containing 52 mg levonorgestrel, indicated for use for up to 5 years"
454318|NCT00476021|P2|Participant Flow|Delayed IUD Insertion|Delayed LNG-IUD insertion
454319|NCT00476021|P1|Participant Flow|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
454320|NCT00476021|O2|Outcome|Follow-up for IUD Insertion for Ineligible Participants|Ineligible participants were followed for 6 months to evaluate whether they received an IUD from their ob/gyn
454321|NCT00476021|O1|Outcome|Pregnancy Within 6 Months for Ineligible Participants|If a participant was found to be ineligible as a result of postenrollment criteria, she was instructed to follow up with her primary obstetrician or midwife for postpartum contraception and delayed IUD insertion
454322|NCT00476021|O2|Outcome|Delayed IUD Insertion|Infection after delayed LNG-IUD insertion
454323|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Infection after postplacental LNG-IUD insertion
454324|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
454325|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
454326|NCT00476021|O1|Outcome|Delayed IUD Insertion|Followed up for delayed IUD insertion
454327|NCT00476021|O1|Outcome|Received Postplacental IUD|Received postplacental LNG-IUD
454328|NCT00476021|O2|Outcome|Delayed IUD Insertion|Delayed LNG-IUD insertion
454329|NCT00476021|O1|Outcome|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
454330|NCT00476021|E2|Reported Event|Delayed IUD Insertion|Delayed LNG-IUD insertion
454331|NCT00476021|E1|Reported Event|Postplacental IUD Insertion|Postplacental LNG-IUD insertion
454332|NCT00476008|B3|Baseline|Total|Total of all reporting groups
454333|NCT00476008|B2|Baseline|Placebo|Placebo : Placebo BID for 12 months
454334|NCT00476008|B1|Baseline|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454335|NCT00476008|P2|Participant Flow|Placebo|Placebo : Placebo BID for 12 months
454336|NCT00476008|P1|Participant Flow|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454337|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454338|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454339|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454340|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454341|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454342|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454343|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454344|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454345|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454346|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454347|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454348|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454349|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454350|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454351|NCT00476008|O2|Outcome|Memantine|Memantine: One tablet memantine (Namenda)10mg morning and evening (BID) for 12 months
454352|NCT00476008|O1|Outcome|Placebo|Placebo: One tablet placebo morning and evening (BID) for 12 months
454353|NCT00476008|O2|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454354|NCT00476008|O1|Outcome|Placebo|Placebo : Placebo BID for 12 months
454355|NCT00476008|O2|Outcome|Placebo|Placebo : Placebo BID for 12 months
454356|NCT00476008|O1|Outcome|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454357|NCT00476008|E2|Reported Event|Placebo|Placebo : Placebo BID for 12 months
454358|NCT00476008|E1|Reported Event|Memantine|Memantine : Memantine (Namenda)10mg BID for 12 months
454359|NCT00475904|B4|Baseline|Total|Total of all reporting groups
456048|NCT00472446|B5|Baseline|Total|Total of all reporting groups
454360|NCT00475904|B3|Baseline|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
454361|NCT00475904|B2|Baseline|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
454362|NCT00475904|B1|Baseline|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
454363|NCT00475904|P3|Participant Flow|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
454364|NCT00475904|P2|Participant Flow|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
454365|NCT00475904|P1|Participant Flow|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
454366|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
454367|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
454368|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
454369|NCT00475904|O3|Outcome|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
454370|NCT00475904|O2|Outcome|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
454371|NCT00475904|O1|Outcome|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
454372|NCT00475904|E3|Reported Event|Placebo Cream and Capsules|placebo NP-1 cream 4gms applied twice daily and placebo gabapentin capsules, taken orally 3 times daily
454373|NCT00475904|E2|Reported Event|Gabapentin Capsules, Placebo Cream|oral gabapentin capsules 600mg three times daily and placebo cream applied 4 grams twice daily
454374|NCT00475904|E1|Reported Event|Amitriptyline 4% Ketamine 2% Cream, Placebo Capsules|amitriptyline 4% ketamine 2% cream 4grams applied twice daily to affected area, placebo capsules taken orally 3 times daily
454375|NCT00475878|B3|Baseline|Total|Total of all reporting groups
454376|NCT00475878|B2|Baseline|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454377|NCT00475878|B1|Baseline|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454378|NCT00475878|P2|Participant Flow|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454379|NCT00475878|P1|Participant Flow|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454380|NCT00475878|O2|Outcome|Placebo|individuals were given a placebo study medication prior to buprenorphine induction
454381|NCT00475878|O1|Outcome|10 mg Escitalopram|individuals were given 10mg escitalopram prior to buprenorphine induction
454382|NCT00475878|O2|Outcome|Placebo|in a double-blind, randomized controlled trial, participants were given placebo prior to buprenorphine induction
454383|NCT00475878|O1|Outcome|10 mg Escitalopram|in a double-blind, randomized controlled trial, participants were given 10mg escitalopram prior to buprenorphine induction
454384|NCT00475878|E2|Reported Event|10 mg Escitalopram|10 mg escitalopram pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454385|NCT00475878|E1|Reported Event|Placebo|placebo pill, daily for 12 weeks, for individuals entering buprenorphine treatment for opioid dependence
454386|NCT00475865|B4|Baseline|Total|Total of all reporting groups
454387|NCT00475865|B3|Baseline|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454388|NCT00475865|B2|Baseline|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454389|NCT00475865|B1|Baseline|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454390|NCT00475865|P3|Participant Flow|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
454391|NCT00475865|P2|Participant Flow|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
454392|NCT00475865|P1|Participant Flow|Placebo + GA|Placebo (for teriflunomide) once daily concomitantly with Glatiramer Acetate [GA] for 24 weeks
454393|NCT00475865|O2|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454394|NCT00475865|O1|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454395|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454396|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454397|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454398|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454399|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454400|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454401|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454402|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454403|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
455029|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
454404|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454405|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454406|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454407|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454408|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454409|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454410|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454411|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454412|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454413|NCT00475865|O3|Outcome|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454414|NCT00475865|O2|Outcome|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454415|NCT00475865|O1|Outcome|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454416|NCT00475865|E3|Reported Event|Teriflunomide 14 mg + GA|Teriflunomide 14 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454417|NCT00475865|E2|Reported Event|Teriflunomide 7 mg + GA|Teriflunomide 7 mg once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454418|NCT00475865|E1|Reported Event|Placebo + GA|Placebo (for Teriflunomide) once daily concomitantly with glatiramer acetate [GA] for 24 weeks
454419|NCT00475852|B3|Baseline|Total|Total of all reporting groups
454420|NCT00475852|B2|Baseline|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454421|NCT00475852|B1|Baseline|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454422|NCT00475852|P2|Participant Flow|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454423|NCT00475852|P1|Participant Flow|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454424|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454425|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454426|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454427|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454428|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454429|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454430|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454431|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454432|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454433|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454434|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454435|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454436|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454437|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454438|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454439|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454440|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454441|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454442|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454443|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454444|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454445|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454446|NCT00475852|O2|Outcome|Placebo|Matching placebo infusion 0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454447|NCT00475852|O1|Outcome|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454448|NCT00475852|E2|Reported Event|Placebo|Matching placebo infusion:0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454449|NCT00475852|E1|Reported Event|Nesiritide|0.01 mcg/kg/min IV infusion (with or without 2 mcg/kg bolus) for 24 to 168 hrs
454450|NCT00475787|B3|Baseline|Total|Total of all reporting groups
454451|NCT00475787|B2|Baseline|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454452|NCT00475787|B1|Baseline|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454453|NCT00475787|P2|Participant Flow|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454454|NCT00475787|P1|Participant Flow|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454455|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454456|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454457|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454458|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454459|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454460|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454461|NCT00475787|O2|Outcome|Arm 2|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454462|NCT00475787|O1|Outcome|Arm 1|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454463|NCT00475787|O2|Outcome|Sham Group|"Detuned Ultrasound~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454464|NCT00475787|O1|Outcome|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454465|NCT00475787|E2|Reported Event|Sham Intervention|Detuned Ultrasound
454466|NCT00475787|E1|Reported Event|Spinal Manipulative Therapy|"Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization.~Spinal Manipulation: Spinal manipulation involves high velocity low amplitude manipulation and flexion distraction and mobilization."
454467|NCT00475735|B7|Baseline|Total|Total of all reporting groups
454468|NCT00475735|B6|Baseline|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
454469|NCT00475735|B5|Baseline|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
454470|NCT00475735|B4|Baseline|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
454471|NCT00475735|B3|Baseline|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
454472|NCT00475735|B2|Baseline|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
454473|NCT00475735|B1|Baseline|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
454474|NCT00475735|P6|Participant Flow|Placebo Then Concerta|These participants received placebo during Treatment Period 1 and Concerta during Treatment Period 2
454475|NCT00475735|P5|Participant Flow|Concerta Then Placebo|These participants received Concerta during Treatment Period 1 and placebo during Treatment Period 2
454476|NCT00475735|P4|Participant Flow|Concerta Then MK-0249|These participants received Concerta during Treatment Period 1 and MK-0249 during Treatment Period 2
454477|NCT00475735|P3|Participant Flow|MK-0249 Then Concerta|These participants received MK-0249 during Treatment Period 1 and Concerta during Treatment Period 2
454478|NCT00475735|P2|Participant Flow|Placebo Then MK-0249|These participants received placebo during Treatment Period 1 and MK-0249 during Treatment Period 2
454479|NCT00475735|P1|Participant Flow|MK-0249 Then Placebo|These participants received MK-0249 during Treatment Period 1 and placebo during Treatment Period 2
454480|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
454481|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
454482|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
454483|NCT00475735|O3|Outcome|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
454557|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
454484|NCT00475735|O2|Outcome|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
454485|NCT00475735|O1|Outcome|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
454486|NCT00475735|E3|Reported Event|Placebo|For 4 of the 6 treatment sequences, patients had one 4-week treatment period with placebo of MK-0249 (tablets) and placebo of Concerta (capsules). For patients assigned to active treatments of MK-0249 or Concerta, in order to preserve the blind, placebo of the non-active component was provided, ie, if MK was assigned (tablets), then placebo of Concerta (capsules) was also provided. Each patient was to dose with tablets and capsules, either active or placebo. Placebo was taken orally once daily.
454487|NCT00475735|E2|Reported Event|Concerta|Titration of Concerta began with two 18-mg capsules (36 mg) for 3 consecutive days, followed by three 18-mg capsules (54 mg) for another 3 consecutive days, ending with four 18-mg capsules (72 mg) for the remainder of the treatment period. If patients were unable to tolerate 72 mg per day, they were allowed to titrate down to 54 mg per day. Concerta was taken orally once daily.
454488|NCT00475735|E1|Reported Event|MK-0249|MK-0249, 10 mg per day was taken orally daily. If patients were unable to tolerate 10 mg per day, they were allowed to titrate down to 5 mg per day.
454489|NCT00475722|B3|Baseline|Total|Total of all reporting groups
454490|NCT00475722|B2|Baseline|2 Mediterranean|"Mediterranean Diet using an exchange list~2 Mediterranean: 6 months telephone counseling"
454491|NCT00475722|B1|Baseline|1 Healthy Eating|"Healthy People 2010 Diet using an exchange list~1 Healthy Eating: 6 months telephone counseling"
454492|NCT00475722|P2|Participant Flow|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
454493|NCT00475722|P1|Participant Flow|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
454494|NCT00475722|O2|Outcome|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
454495|NCT00475722|O1|Outcome|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
454496|NCT00475722|E2|Reported Event|2 Mediterranean|"Mediterranean Diet~Mediterranean Diet through dietary counseling: 6 months telephone counseling"
454497|NCT00475722|E1|Reported Event|1 Healthy Eating|"Healthy People 2010 Diet~Healthy People 2010 Diet through dietary counseling: 6 months telephone counseling"
454498|NCT00475709|B1|Baseline|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
454499|NCT00475709|P1|Participant Flow|Subjects Implanted With Trifecta Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
454500|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
454501|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
454502|NCT00475709|O1|Outcome|Trifecta Aortic Heart Valve|All subjects enrolled into the study are implanted with the Trifecta Aortic Heart Valve.
454503|NCT00475709|E1|Reported Event|Subjects Implanted With Trifecta Valve|
454504|NCT00475670|B3|Baseline|Total|Total of all reporting groups
454505|NCT00475670|B2|Baseline|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454506|NCT00475670|B1|Baseline|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454507|NCT00475670|P2|Participant Flow|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/square meter (m^2), IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454508|NCT00475670|P1|Participant Flow|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 milligrams per kilogram (mg/kg), intravenously (IV), on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454509|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454510|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454555|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454511|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454512|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454513|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454514|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454515|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454516|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454517|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454518|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454519|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454520|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454521|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454522|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454523|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454524|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454525|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454526|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
455030|NCT00474630|O2|Outcome|Placebo|Placebo
454527|NCT00475670|O2|Outcome|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454528|NCT00475670|O1|Outcome|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454529|NCT00475670|E2|Reported Event|Trastuzumab, Taxane|Participants received either an initial loading dose of trastuzumab 4 mg/kg IV on Day 1, followed by 2 mg/kg IV once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death. Participants also received one of the following taxanes (at the investigator’s discretion) for at least 18 weeks: docetaxel 100 mg/m^2, IV, once every 3 weeks, OR, paclitaxel 75 mg/m^2, IV, once per week, OR, paclitaxel 175 mg/m^2, IV, once every 3 weeks.
454530|NCT00475670|E1|Reported Event|Trastuzumab Monotherapy|Participants received either an initial loading dose of trastuzumab 4 mg/kg, IV, on Day 1, followed by 2 mg/kg, IV, once per week, or an initial loading dose of 8 mg/kg IV on Day 1, followed by 6 mg/kg IV once every 3 weeks, until disease progression, unacceptable toxicity, withdrawal or death.
454531|NCT00475657|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454532|NCT00475657|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454533|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454534|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454535|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454536|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454537|NCT00475657|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454538|NCT00475657|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles
454539|NCT00475501|B5|Baseline|Total|Total of all reporting groups
454540|NCT00475501|B4|Baseline|Vehicle Placebo|weekly vehicle injection daily placebo pill
454541|NCT00475501|B3|Baseline|Testosterone Finasteride|125 mg testosterone enanthate/week i.m. 5 mg finasteride/day p.o.
454542|NCT00475501|B2|Baseline|Vehicle Finasteride|weekly vehicle injection 5 mg finasteride/day p.o.
454543|NCT00475501|B1|Baseline|Testosterone Vehicle|125 mg testosterone enanthate/week i.m. daily placebo pill
454544|NCT00475501|P4|Participant Flow|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454545|NCT00475501|P3|Participant Flow|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454546|NCT00475501|P2|Participant Flow|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454547|NCT00475501|P1|Participant Flow|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454548|NCT00475501|O4|Outcome|Arm 4|"placebo~Life Satisfaction A"
454549|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
454550|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Life Satisfaction A"
454551|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Life Satisfaction A"
454552|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454553|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454554|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454556|NCT00475501|O4|Outcome|Arm 4|"placebo~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
456547|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
454558|NCT00475501|O2|Outcome|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
454559|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Daily dietary protein intake (gm/kg body weight) derived from 3-day food log"
454560|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454561|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454562|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454563|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454564|NCT00475501|O4|Outcome|Arm 4|"placebo~Benton Test -Judgment of Line Orientation"
454565|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Benton Test -Judgment of Line Orientation"
454566|NCT00475501|O2|Outcome|Arm 2|"finasteride~Benton Test -Judgment of Line Orientation~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454567|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Benton Test -Judgment of Line Orientation"
454568|NCT00475501|O4|Outcome|Arm 4|"placebo~Trail Making Test A"
454569|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Trail Making Test A"
454570|NCT00475501|O2|Outcome|Arm 2|"finasteride~Trail Making Test A Finasteride : 5 mg, oral, once/day, for 52 weeks"
454571|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Trail Making Test A"
454572|NCT00475501|O4|Outcome|Arm 4|"placebo~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
454573|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
454574|NCT00475501|O2|Outcome|Arm 2|"finasteride~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test Finasteride : 5 mg, oral, once/day, for 52 weeks"
454575|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~30 minute recall portion of Rey Osterrieth Complex Figure (ROCF) test"
454576|NCT00475501|O4|Outcome|Vehicle Placebo|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
454577|NCT00475501|O3|Outcome|Testosterone Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
454578|NCT00475501|O2|Outcome|Vehicle Finasteride|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
454579|NCT00475501|O1|Outcome|Testosterone Vehicle|Geriatric Depression Scale (GDS): This 15-item, yes/no questionnaire will be administered at baseline, after 3, 6, 9 and 12 months of treatment and at follow-up.
454580|NCT00475501|O4|Outcome|Arm 4|"placebo~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454581|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454582|NCT00475501|O2|Outcome|Arm 2|"finasteride~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed.~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454583|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Collection of 3-day food logs with counseling of subjects : subject weighs food portions and completes food log, once/3 months, for 18 months (including 6-month follow-up. Counseling will be healthy ways to increase protein intake, if needed."
454584|NCT00475501|O4|Outcome|Vehicle Placebo|grip strength measure on a dynamometer
454585|NCT00475501|O3|Outcome|Testosterone Finasteride|grip strength measure on a dynamometer
454586|NCT00475501|O2|Outcome|Vehicle Finasteride|grip strength measure on a dynamometer
454587|NCT00475501|O1|Outcome|Testosterone Vehicle|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~grip strength measure on a dynamometer"
454588|NCT00475501|O4|Outcome|Arm 4|"placebo~Measurement of leg press strength, 1-RM"
454589|NCT00475501|O3|Outcome|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks~Measurement of leg press strength, 1-RM"
454590|NCT00475501|O2|Outcome|Arm 2|"finasteride~Measurement of leg press strength, 1-RM Finasteride : 5 mg, oral, once/day, for 52 weeks"
458300|NCT00466167|B4|Baseline|Total|Total of all reporting groups
454591|NCT00475501|O1|Outcome|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Measurement of leg press strength, 1-RM"
454592|NCT00475501|E4|Reported Event|Arm 4|placebo
454593|NCT00475501|E3|Reported Event|Arm 3|"testosterone enanthate + finasteride~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454594|NCT00475501|E2|Reported Event|Arm 2|"finasteride~Finasteride : 5 mg, oral, once/day, for 52 weeks"
454595|NCT00475501|E1|Reported Event|Arm 1|"testosterone enanthate~Testosterone Enanthate : 125 mg, i.m. injection, once/week, for 52 weeks"
454596|NCT00475423|B1|Baseline|Rituximab|Participants received rituximab 1000 mg IV on Days 1 and 15.
454597|NCT00475423|P1|Participant Flow|Rituximab|Participants received rituximab 1000 milligrams (mg) intravenously (IV) on Days 1 and 15.
454598|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454599|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454600|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454601|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454602|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454603|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454604|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454605|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454606|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454607|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454608|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454609|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454610|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454611|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454612|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454613|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454614|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454615|NCT00475423|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454616|NCT00475423|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV on Days 1 and 15.
454617|NCT00475332|B1|Baseline|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
454618|NCT00475332|P1|Participant Flow|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
454619|NCT00475332|O1|Outcome|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
454620|NCT00475332|O1|Outcome|Radiation Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
454621|NCT00475332|E1|Reported Event|Radiotherapy Followed by Bexxar|All patients enrolled received the same treatment: 20 Gray of radiation in 10 treatments followed by Bexxar.
454622|NCT00475319|B4|Baseline|Total|Total of all reporting groups
454623|NCT00475319|B3|Baseline|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454624|NCT00475319|B2|Baseline|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454625|NCT00475319|B1|Baseline|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454626|NCT00475319|P3|Participant Flow|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454627|NCT00475319|P2|Participant Flow|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454628|NCT00475319|P1|Participant Flow|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454629|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454630|NCT00475319|O2|Outcome|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454631|NCT00475319|O1|Outcome|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454632|NCT00475319|O3|Outcome|Placebo|0% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
454633|NCT00475319|O2|Outcome|2% OPC-12759 Ophthalmic Suspension|2% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
454634|NCT00475319|O1|Outcome|1% OPC-12759 Ophthalmic Suspension|1% OPC-12759 ophthalmic suspension received one drop to both eyes four times a day for 4 weeks.
454635|NCT00475319|E3|Reported Event|Placebo|0% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454636|NCT00475319|E2|Reported Event|2% OPC-12759 Groups|2% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454637|NCT00475319|E1|Reported Event|1% OPC-12759 Groups|1% OPC-12759 ophthalmic suspension received one drop of to both eyes four times a day for 4 weeks
454638|NCT00475306|B5|Baseline|Total|Total of all reporting groups
454639|NCT00475306|B4|Baseline|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
454640|NCT00475306|B3|Baseline|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
454641|NCT00475306|B2|Baseline|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
454642|NCT00475306|B1|Baseline|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
454643|NCT00475306|P4|Participant Flow|Metoclopramide 10+Diphenhydramine|Metoclopramide 10 mg co-administered with diphenhydramine 25 mg, intravenously
454644|NCT00475306|P3|Participant Flow|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
454645|NCT00475306|P2|Participant Flow|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
454646|NCT00475306|P1|Participant Flow|Metoclopramide 20 mg+Diphenhydramine|Metoclopramide 20mg co-administered with diphenhydramine 25 mg, intravenously
454647|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
454648|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
454649|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
454650|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
454651|NCT00475306|O4|Outcome|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
454652|NCT00475306|O3|Outcome|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
454653|NCT00475306|O2|Outcome|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
454654|NCT00475306|O1|Outcome|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
454655|NCT00475306|E4|Reported Event|Metoclopramide 10+Diphenhydramine|Metoclopramide 10mg co-administered with diphenhydramine 25mg, intravenously
454656|NCT00475306|E3|Reported Event|Metoclopramide 10 + Placebo|Metoclopramide 10 mg co-administered with placebo, intravenously
454657|NCT00475306|E2|Reported Event|Metoclopramide 20+Placebo|Metoclopramide 20 mg co-administered with placebo, intravenously
454658|NCT00475306|E1|Reported Event|Metoclopramide 20mg+Diphenhydramine|Metoclopramide 20 mg co-administered with diphenhydramine 25mg, intravenously
454659|NCT00475241|B3|Baseline|Total|Total of all reporting groups
454660|NCT00475241|B2|Baseline|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
454661|NCT00475241|B1|Baseline|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
454662|NCT00475241|P2|Participant Flow|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
454663|NCT00475241|P1|Participant Flow|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
454664|NCT00475241|O2|Outcome|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
454665|NCT00475241|O1|Outcome|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
454666|NCT00475241|E2|Reported Event|Present Centered Therapy|"Present centered therapy for PTSD~Present centered therapy for PTSD: present focused coping and problem solving for PTSD"
454667|NCT00475241|E1|Reported Event|Prolonged Exposure|"Prolonged exposure therapy for PTSD~Prolonged Exposure therapy for PTSD: exposure-based treatment for PTSD"
454668|NCT00475176|B1|Baseline|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
454669|NCT00475176|P1|Participant Flow|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin. After screening evaluation, patients will receive a first course of 2 weeks of peginterferon alfa-2a (180 micrograms weekly) and ribavirin (1000-1200 mg daily) during which symptoms, routine laboratory tests, HCV RNA levels, natural killer (NK) cell activity, and lymphocyte interferon-signaling responses will be monitored. After a 4-week washout period, patients will start SAMe (800 mg twice daily) for 2 weeks and then begin a second course of peginterferon and ribavirin in the same doses with similar monitoring. Therapy will be continued for at least 12 weeks, and patients with an early viral response will continue for a full 48 weeks.
454670|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
454671|NCT00475176|O1|Outcome|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
454672|NCT00475176|E1|Reported Event|Hepatitis C Treated With Peginterferon and Ribavirin|Patients infected with hepatitis C virus (HCV) treated with peginterferon alpha-2a and ribavirin
454673|NCT00475150|B3|Baseline|Total|Total of all reporting groups
454674|NCT00475150|B2|Baseline|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454675|NCT00475150|B1|Baseline|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454676|NCT00475150|P2|Participant Flow|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454677|NCT00475150|P1|Participant Flow|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454678|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454679|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454763|NCT00474968|B1|Baseline|SoftPAP|Samples collected using the SoftPAP Collector
454680|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454681|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454682|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454683|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454684|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454685|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454686|NCT00475150|O2|Outcome|Myelodysplastic Syndrome (MDS)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454687|NCT00475150|O1|Outcome|Acute Myeloid Leukemia (AML)|Patients receive 30 mg oral cediranib maleate QD on days 1-28. Treatment repeats every 28 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.
454688|NCT00475150|E1|Reported Event|All Patients Receiving Cediranib Maleate|All patients receiving oral cediranib maleate, regardless of diagnosis were analyzed for toxicity.
454689|NCT00475085|B5|Baseline|Total|Total of all reporting groups
454690|NCT00475085|B4|Baseline|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454691|NCT00475085|B3|Baseline|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454692|NCT00475085|B2|Baseline|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454693|NCT00475085|B1|Baseline|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454694|NCT00475085|P4|Participant Flow|Arm 4 Palonosetron, Dexamethasone, Compazine, Dexamethasone|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454695|NCT00475085|P3|Participant Flow|Arm 3 Aprepitant, Palonosetron, Dexamethasone|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454696|NCT00475085|P2|Participant Flow|Arm 2 Granisetron, Dexamethasone, Compazine|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454697|NCT00475085|P1|Participant Flow|Arm 1 Palonosetron, Dexamethasone, Compazine|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454698|NCT00475085|O4|Outcome|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454699|NCT00475085|O3|Outcome|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454700|NCT00475085|O2|Outcome|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454701|NCT00475085|O1|Outcome|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454702|NCT00475085|E4|Reported Event|Arm IV|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and oral dexamethasone once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454764|NCT00474968|P2|Participant Flow|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
454703|NCT00475085|E3|Reported Event|Arm I|"Patients receive palonosetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454704|NCT00475085|E2|Reported Event|Arm III|"Patients receive palonosetron hydrochloride IV and dexamethasone IV once on day 1, oral aprepitant once daily on days 1-3, and oral dexamethasone once daily and oral placebo twice daily on days 2 and 3.~placebo : Given orally~aprepitant : Given orally or IV~palonosetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454705|NCT00475085|E1|Reported Event|Arm II|"Patients receive granisetron hydrochloride IV, dexamethasone IV, and oral placebo once on day 1 and oral prochlorperazine 3 times daily and another oral placebo once daily on days 2 and 3.~placebo : Given orally~prochlorperazine : Given orally or IV~granisetron hydrochloride : Given orally or IV~dexamethasone : Given orally or IV"
454706|NCT00475033|B3|Baseline|Total|Total of all reporting groups
454707|NCT00475033|B2|Baseline|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454708|NCT00475033|B1|Baseline|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454709|NCT00475033|P2|Participant Flow|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454710|NCT00475033|P1|Participant Flow|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454711|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454712|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454713|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454714|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454765|NCT00474968|P1|Participant Flow|SoftPAP|Samples collected using the SoftPAP Collector
454766|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
454767|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
454768|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
454715|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454716|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454717|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454718|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454719|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454720|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454721|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454722|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454723|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454724|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454769|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
454770|NCT00474968|O2|Outcome|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
458644|NCT00465101|O1|Outcome|Length of Lasing Time|
454725|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454726|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454727|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454728|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454729|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454730|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454731|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454732|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454733|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454734|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454771|NCT00474968|O1|Outcome|SoftPAP|Samples collected using the SoftPAP Collector
454772|NCT00474968|E2|Reported Event|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
458645|NCT00465101|O1|Outcome|Length of Procedure (Min)|
454735|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454736|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454737|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454738|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose). Co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454739|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454740|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454741|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454742|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454743|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454744|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454773|NCT00474968|E1|Reported Event|SoftPAP|Samples collected using the SoftPAP Collector
454804|NCT00474929|E4|Reported Event|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
454745|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454746|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454747|NCT00475033|O2|Outcome|7vPnC|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Hib conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454748|NCT00475033|O1|Outcome|13vPnC|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose), co-administered with Pentacel® (a commercially available combination diphtheria, tetanus, acellular pertussis, inactivated polio and Haemophilus influenzae type b [Hib] conjugate vaccine ) at 2, 4, and 6 months of age; NeisVac-C® (a commercially available meningococcal C tetanus toxoid conjugate vaccine) at 2 and 6 months of age (infant series) and 12 months of age (toddler dose); a single type of commercially available Measles, Mumps, and Rubella vaccine (MMR) at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454749|NCT00475033|E8|Reported Event|7vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454750|NCT00475033|E7|Reported Event|13vPnC Toddler Dose 6-Month Follow-up|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.
454751|NCT00475033|E6|Reported Event|7vPnC Toddler Dose|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (toddler dose), co-administered with NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=108; systematic (solicited) Any Local Reactions N=86; systematic (solicited) Any Systemic Events N=193."
454752|NCT00475033|E5|Reported Event|13vPnC Toddler Dose|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 12 months of age (toddler dose), co-administered NeisVac-C® at 12 months of age (toddler dose); a single type of commercially available MMR at 12 months; and a single type of commercially available varicella vaccine at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=110; systematic (solicited) Any Local Reactions N=84; systematic (solicited) Any Systemic Events N=199."
454753|NCT00475033|E4|Reported Event|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
454754|NCT00475033|E3|Reported Event|13vPnC After the Infant Series|Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).
454755|NCT00475033|E2|Reported Event|7vPnC Infant Series|"Subjects received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=230; systematic (solicited) Any Local Reactions N=148; systematic (solicited) Any Systemic Events N=279."
454756|NCT00475033|E1|Reported Event|13vPnC Infant Series|"Subjects received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) at 2, 4, and 6 months of age (infant series), co-administered with Pentacel® at 2, 4, and 6 months of age; NeisVac-C® at 2 and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for nonsystematic (unsolicited) Other Adverse Events N=229; systematic (solicited) Any Local Reactions N=144; systematic (solicited) Any Systemic Events N=273."
454757|NCT00474994|B1|Baseline|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
454758|NCT00474994|P1|Participant Flow|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
454759|NCT00474994|O1|Outcome|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
454760|NCT00474994|E1|Reported Event|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas|Sunitinib (Sutent®, SU11248) in Non-GIST Sarcomas
454761|NCT00474968|B3|Baseline|Total|Total of all reporting groups
454762|NCT00474968|B2|Baseline|Brush/Spatula|Samples collected using an endocervical brush and cervical spatula
454774|NCT00474955|B1|Baseline|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454775|NCT00474955|P1|Participant Flow|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a [Pegasys] [40 kilo Dalton (kDa)], 180 micrograms (mcg) as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated glomerular filtration rate (GFR) of <15 milliliter (mL)/minute (min) were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454776|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454777|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454778|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454779|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454780|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454781|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454782|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454783|NCT00474955|O1|Outcome|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454784|NCT00474955|E1|Reported Event|Peginterferon Alpha-2a|Eligible participants were administered peginterferon alpha-2a (40 kDa), 180 mcg as a subcutaneous injection, once in a week, for 48 weeks. Participants with a calculated GFR of <15 mL/min were administered a reduced dose of 135 mcg as a subcutaneous injection, once in a week, for 48 weeks.
454785|NCT00474929|B6|Baseline|Total|Total of all reporting groups
454786|NCT00474929|B5|Baseline|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
454787|NCT00474929|B4|Baseline|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
454788|NCT00474929|B3|Baseline|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
454789|NCT00474929|B2|Baseline|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
454790|NCT00474929|B1|Baseline|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day;
454791|NCT00474929|P5|Participant Flow|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
454792|NCT00474929|P4|Participant Flow|Phase I, Dose Level 3|Phase I: Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
454793|NCT00474929|P3|Participant Flow|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
454794|NCT00474929|P2|Participant Flow|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
454795|NCT00474929|P1|Participant Flow|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
454796|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
454797|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). This includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77).
454798|NCT00474929|O1|Outcome|Sorafenib 200 mg Twice Daily, RAD001 5mg Every Day|"This endpoint was analyzed using all patients treated at the MTD (Dose Level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day). Due to concerns about adverse events and frequent dose reductions seen on later cycles at dose level 2, the PI felt it was in the best interest of the patients to choose dose level 1 as the MTD and the dose level for Phase II.~Therefore, the analysis of the Phase II endpoint includes the eligible Phase I participants treated at Dose Level 1 (N=5) and it includes all participants treated in Phase II (N=77)."
454799|NCT00474929|O4|Outcome|Phase I, Dose Level 3|Dose level 3: Sorafenib 400 mg twice daily, RAD001 10mg every day
454800|NCT00474929|O3|Outcome|Phase I, Dose Level 2|Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
454801|NCT00474929|O2|Outcome|Phase I, Dose Level 1|Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
454802|NCT00474929|O1|Outcome|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
454803|NCT00474929|E5|Reported Event|Phase II|Phase II: Sorafenib 200 mg twice daily, RAD001 5mg every day;
454805|NCT00474929|E3|Reported Event|Phase I, Dose Level 2|Phase I: Dose level 2: Sorafenib 400 mg twice daily, RAD001 5mg every day
454806|NCT00474929|E2|Reported Event|Phase I, Dose Level 1|Phase I: Dose level 1: Sorafenib 200 mg twice daily, RAD001 5mg every day
454807|NCT00474929|E1|Reported Event|Phase I, Dose Level 0|Phase I: Dose level 0: Sorafenib 200 mg twice daily, RAD001 5mg every other day
454808|NCT00474903|B4|Baseline|Total|Total of all reporting groups
454809|NCT00474903|B3|Baseline|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454810|NCT00474903|B2|Baseline|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454811|NCT00474903|B1|Baseline|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
454812|NCT00474903|P3|Participant Flow|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454813|NCT00474903|P2|Participant Flow|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454814|NCT00474903|P1|Participant Flow|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
454815|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454816|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454817|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
454818|NCT00474903|O3|Outcome|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454819|NCT00474903|O2|Outcome|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454820|NCT00474903|O1|Outcome|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
454821|NCT00474903|E3|Reported Event|Arm III (Higher-dose Aspirin, Palcebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (325 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454822|NCT00474903|E2|Reported Event|Arm II (Low-dose Aspirin, Placebo, Esomeprazole Magnesium)|"Patients receive both an oral placebo and acetylsalicylic acid (81 mg dose), once daily and oral esomeprazole magnesium (40 mg, twice daily).~acetylsalicylic acid: Given orally esomeprazole magnesium: Given orally placebo: Given orally"
454823|NCT00474903|E1|Reported Event|Arm I (Placebo, Esomeprazole Magnesium)|"Patients receive two oral placebos once daily and oral esomeprazole magnesium (40 mg, twice daily).~esomeprazole magnesium: Given orally placebo: Given orally"
454824|NCT00474851|B3|Baseline|Total|Total of all reporting groups
454825|NCT00474851|B2|Baseline|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454826|NCT00474851|B1|Baseline|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454827|NCT00474851|P2|Participant Flow|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454828|NCT00474851|P1|Participant Flow|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454829|NCT00474851|O2|Outcome|Placebo Group|"Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454830|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454831|NCT00474851|O2|Outcome|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454832|NCT00474851|O1|Outcome|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454833|NCT00474851|E2|Reported Event|Placebo Group|"Placebo group~Placebo: Placebo capsule 1 pill PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454834|NCT00474851|E1|Reported Event|Intervention Group|"Conjugated equine estrogens: Conjugated estrogens 0.625 mg PO daily~Norethindrone acetate: Norethindrone acetate 5 mg PO daily"
454835|NCT00474812|B1|Baseline|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454836|NCT00474812|P1|Participant Flow|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454837|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454838|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454839|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454840|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454841|NCT00474812|O1|Outcome|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454842|NCT00474812|E1|Reported Event|Dasatinib Treatment|Patients receive oral dasatinib twice daily on days 1-28.
454843|NCT00474786|B3|Baseline|Total|Total of all reporting groups
454844|NCT00474786|B2|Baseline|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454845|NCT00474786|B1|Baseline|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454846|NCT00474786|P2|Participant Flow|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454847|NCT00474786|P1|Participant Flow|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454848|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454849|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454850|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454851|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454852|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454853|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454854|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454855|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454856|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454857|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454858|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454859|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454860|NCT00474786|O2|Outcome|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454861|NCT00474786|O1|Outcome|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454862|NCT00474786|E2|Reported Event|Sorafenib|Sorafenib 400 mg (two 200 mg tablets) by mouth (PO) twice daily (BID) administered in 6 week cycles for up to 24 months. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454863|NCT00474786|E1|Reported Event|Temsirolimus|Temsirolimus 25 milligrams (mg) once weekly by intravenous (IV) infusion administered in 6 week cycles for up to 24 months, participants were premedicated with 25-50 mg IV diphenydramine 30 minutes before temsirolimus infusion. In event of toxicity, dose could be modified or held according to the protocol or at the discretion of the investigator.
454864|NCT00474760|B8|Baseline|Total|Total of all reporting groups
454865|NCT00474760|B7|Baseline|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454866|NCT00474760|B6|Baseline|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
454867|NCT00474760|B5|Baseline|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
454868|NCT00474760|B4|Baseline|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454869|NCT00474760|B3|Baseline|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454870|NCT00474760|B2|Baseline|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454871|NCT00474760|B1|Baseline|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454872|NCT00474760|P7|Participant Flow|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D Ewing’s sarcoma family of tumors [ESFT] extension cohort.
454873|NCT00474760|P6|Participant Flow|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D adrenocortical carcinoma [ACC] and sarcoma extension cohort.
454874|NCT00474760|P5|Participant Flow|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for recommended Phase 2 dose [RP2D] extension cohort.
454875|NCT00474760|P4|Participant Flow|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454876|NCT00474760|P3|Participant Flow|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454877|NCT00474760|P2|Participant Flow|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454878|NCT00474760|P1|Participant Flow|Figitumumab 3 mg/kg|Figitumumab 3 milligram/kilogram (mg/kg) was supplied as a liquid solution administered as an intravenous (IV) infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454879|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
454880|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation and RP2D extension cohorts.
454881|NCT00474760|O1|Outcome|Figitumumab 3, 6, 10, 20 mg/kg|Figitumumab 3, 6, 10, or 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration for dose escalation, RP2D extension, and RP2D ACC and sarcoma extension cohorts, 4 weeks in duration for RP2D ESFT extension cohort).
454882|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454883|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454884|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454885|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454886|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454887|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454888|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454889|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454890|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
455028|NCT00474630|O2|Outcome|Placebo|Placebo
454891|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454892|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454893|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454894|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454895|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454896|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454897|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454898|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454899|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454900|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454901|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454902|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454903|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454904|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454905|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454906|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454907|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454908|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454909|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454910|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454911|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454912|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454913|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454914|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454915|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454916|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454917|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454918|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454919|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454920|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454921|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454922|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454923|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454924|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454925|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454926|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454927|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454928|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454929|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454930|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454931|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454932|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454933|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454934|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454935|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454936|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454937|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454938|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454939|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454940|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454941|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454942|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454943|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454944|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
458646|NCT00465101|O1|Outcome|Length of Catheterization|
454945|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454946|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454947|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454948|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454949|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454950|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454951|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454952|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454953|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454954|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454955|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454956|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454957|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454958|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454959|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454960|NCT00474760|O2|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454961|NCT00474760|O1|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454962|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454963|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D Every 3 Weeks|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D, and RP2D ACC and sarcoma extension cohorts.
454964|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454965|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454966|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454967|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454968|NCT00474760|O7|Outcome|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454969|NCT00474760|O6|Outcome|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
454970|NCT00474760|O5|Outcome|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
454971|NCT00474760|O4|Outcome|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454972|NCT00474760|O3|Outcome|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454973|NCT00474760|O2|Outcome|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454974|NCT00474760|O1|Outcome|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454975|NCT00474760|E7|Reported Event|Figitumumab 20 mg/kg RP2D ESFT|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (4 weeks in duration) for RP2D ESFT extension cohort.
454976|NCT00474760|E6|Reported Event|Figitumumab 20 mg/kg RP2D ACC+Sarcoma|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D ACC and sarcoma extension cohort.
454977|NCT00474760|E5|Reported Event|Figitumumab 20 mg/kg RP2D|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for RP2D extension cohort.
454978|NCT00474760|E4|Reported Event|Figitumumab 20 mg/kg|Figitumumab 20 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454979|NCT00474760|E3|Reported Event|Figitumumab 10 mg/kg|Figitumumab 10 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454980|NCT00474760|E2|Reported Event|Figitumumab 6 mg/kg|Figitumumab 6 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454981|NCT00474760|E1|Reported Event|Figitumumab 3 mg/kg|Figitumumab 3 mg/kg was supplied as a liquid solution administered as an IV infusion over 2.5 hours (plus or minus 15 minutes) on Day 1 of each cycle (3 weeks in duration) for dose escalation cohort.
454982|NCT00474708|B3|Baseline|Total|Total of all reporting groups
454983|NCT00474708|B2|Baseline|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
454984|NCT00474708|B1|Baseline|Venlafaxine XR|75-225 mg per day
454985|NCT00474708|P2|Participant Flow|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
454986|NCT00474708|P1|Participant Flow|Venlafaxine XR|75-225 mg per day
454987|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
454988|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
454989|NCT00474708|O2|Outcome|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
454990|NCT00474708|O1|Outcome|Venlafaxine XR|75-225 mg per day
454991|NCT00474708|E2|Reported Event|SSRI or Conventional Antidepressant Group|Selective serotonin reuptake inhibitor (SSRI) or Conventional Antidepressants, dependent upon the selected antidepressant, dosages ranging from 20 mg to 250 mg.
454992|NCT00474708|E1|Reported Event|Venlafaxine XR|75-225 mg per day
454993|NCT00474630|B3|Baseline|Total|Total of all reporting groups
454994|NCT00474630|B2|Baseline|Placebo|Placebo
454995|NCT00474630|B1|Baseline|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
454996|NCT00474630|P2|Participant Flow|Placebo|Placebo
454997|NCT00474630|P1|Participant Flow|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
454998|NCT00474630|O2|Outcome|Placebo|Placebo
454999|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455000|NCT00474630|O2|Outcome|Placebo|Placebo
455001|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455002|NCT00474630|O2|Outcome|Placebo|Placebo
455003|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455004|NCT00474630|O2|Outcome|Placebo|Placebo
455005|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455006|NCT00474630|O2|Outcome|Placebo|Placebo
455007|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455008|NCT00474630|O2|Outcome|Placebo|Placebo
455009|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455010|NCT00474630|O2|Outcome|Placebo|Placebo
455011|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455012|NCT00474630|O2|Outcome|Placebo|Placebo
455013|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455014|NCT00474630|O2|Outcome|Placebo|Placebo
455015|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455016|NCT00474630|O2|Outcome|Placebo|Placebo
455017|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455018|NCT00474630|O2|Outcome|Placebo|Placebo
455019|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455020|NCT00474630|O2|Outcome|Placebo|Placebo
455021|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455022|NCT00474630|O2|Outcome|Placebo|Placebo
455023|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455024|NCT00474630|O2|Outcome|Placebo|Placebo
455025|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455026|NCT00474630|O2|Outcome|Placebo|Placebo
455027|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455031|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455032|NCT00474630|O2|Outcome|Placebo|Placebo
455033|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455034|NCT00474630|O2|Outcome|Placebo|Placebo
455035|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455036|NCT00474630|O2|Outcome|Placebo|Placebo
455037|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455038|NCT00474630|O2|Outcome|Placebo|Placebo
455039|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455040|NCT00474630|O2|Outcome|Placebo|Placebo
455041|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455042|NCT00474630|O2|Outcome|Placebo|Placebo
455043|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455044|NCT00474630|O2|Outcome|Placebo|Placebo
455045|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/bupropion SR 360 mg/ day
455046|NCT00474630|O2|Outcome|Placebo|Placebo
455047|NCT00474630|O1|Outcome|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg/day
455048|NCT00474630|E2|Reported Event|Placebo|Placebo
455049|NCT00474630|E1|Reported Event|NB32|Naltrexone SR 32 mg/Bupropion SR 360 mg daily
455050|NCT00474539|B3|Baseline|Total|Total of all reporting groups
455051|NCT00474539|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455052|NCT00474539|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455053|NCT00474539|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455054|NCT00474539|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455055|NCT00474539|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455056|NCT00474539|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and combined diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and combined DTPa, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix IPV + Hib) at the 15-month visit (toddler dose). Measles, mumps, and rubella vaccine (MMR) was administered without study vaccine at the 12-month visit.
455057|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455058|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455059|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
455060|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455061|NCT00474539|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455062|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
455063|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|SParticipants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455064|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455065|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455066|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455067|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455068|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose).
455069|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455070|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3).
455071|NCT00474539|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
455072|NCT00474539|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit.
455073|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2)
455074|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
455075|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
455076|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
455077|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
455078|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
455079|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
455080|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
455081|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
455082|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
455083|NCT00474539|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
455084|NCT00474539|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit.
455085|NCT00474539|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa and at the 6-month visit.
455086|NCT00474539|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa and at the 6-month visit.
455087|NCT00474539|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
455088|NCT00474539|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 4-month visit.
455089|NCT00474539|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
455090|NCT00474539|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2-month visit.
455091|NCT00474539|O2|Outcome|7vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
455092|NCT00474539|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2).
455093|NCT00474539|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
455362|NCT00474240|E3|Reported Event|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
455094|NCT00474539|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits (infant series Dose 2) and one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit (infant series dose 3). Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix IPV + Hib at the 15-month visit (toddler dose). MMR was administered without study vaccine at the 12-month visit. Adverse events were collected for approximately six months after last visit
455095|NCT00474539|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
455096|NCT00474539|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix-IPV+Hib at the 15-month visit. Adverse events were collected for approximately one month after toddler dose.
455097|NCT00474539|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
455098|NCT00474539|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at the 6-month visit. Adverse events were collected from approximately one month after dose 3 to toddler dose.
455099|NCT00474539|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
455100|NCT00474539|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Infanrix hexa at the 2- and 4-month visits. Adverse events were collected from dose 1 to approximately one month after dose 3.
455101|NCT00474526|B18|Baseline|TOTAL|Total of all reporting groups
455102|NCT00474526|B17|Baseline|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
455103|NCT00474526|B16|Baseline|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
455104|NCT00474526|B15|Baseline|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
455105|NCT00474526|B14|Baseline|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455106|NCT00474526|B13|Baseline|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455107|NCT00474526|B12|Baseline|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
455108|NCT00474526|B11|Baseline|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455109|NCT00474526|B10|Baseline|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455110|NCT00474526|B9|Baseline|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455111|NCT00474526|B8|Baseline|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455112|NCT00474526|B7|Baseline|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
455113|NCT00474526|B6|Baseline|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
455363|NCT00474240|E2|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
455364|NCT00474240|E1|Reported Event|Placebo|Placebo capsule taken orally once daily
455114|NCT00474526|B5|Baseline|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455115|NCT00474526|B4|Baseline|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455116|NCT00474526|B3|Baseline|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455117|NCT00474526|B2|Baseline|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455118|NCT00474526|B1|Baseline|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455119|NCT00474526|P17|Participant Flow|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
455120|NCT00474526|P16|Participant Flow|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
455121|NCT00474526|P15|Participant Flow|LA6A (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 12 and a second dose of MenACWY at 15 months of age.
455122|NCT00474526|P14|Participant Flow|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455123|NCT00474526|P13|Participant Flow|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455124|NCT00474526|P12|Participant Flow|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
455125|NCT00474526|P11|Participant Flow|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455126|NCT00474526|P10|Participant Flow|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455127|NCT00474526|P9|Participant Flow|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455128|NCT00474526|P8|Participant Flow|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455129|NCT00474526|P7|Participant Flow|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
455130|NCT00474526|P6|Participant Flow|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age.
455131|NCT00474526|P5|Participant Flow|US4A (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455395|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455132|NCT00474526|P4|Participant Flow|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455133|NCT00474526|P3|Participant Flow|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455134|NCT00474526|P2|Participant Flow|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455135|NCT00474526|P1|Participant Flow|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455136|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455137|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455138|NCT00474526|O2|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455139|NCT00474526|O1|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455140|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
455141|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455142|NCT00474526|O2|Outcome|LA3B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
455143|NCT00474526|O1|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455144|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455145|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455146|NCT00474526|O2|Outcome|LA1B (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455147|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455148|NCT00474526|O3|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455149|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
458647|NCT00465101|O1|Outcome|Length of Hospital Stay (Hours)|
455150|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455151|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455152|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455153|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455154|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455155|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455156|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455157|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455158|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455159|NCT00474526|O2|Outcome|LA3A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455160|NCT00474526|O1|Outcome|LA1A (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455161|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455162|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455163|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455164|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455165|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455166|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455167|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
458648|NCT00465101|O1|Outcome|Return to Activity (Days)|
455168|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455169|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455170|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455171|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455172|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455173|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455174|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455175|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455176|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455177|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455178|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines) (16m)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455179|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only) (12m)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455180|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines) (12m)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455181|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455182|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455183|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455184|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455185|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455186|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455396|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
458649|NCT00465101|O8|Outcome|5 Years|
455187|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455188|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455189|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455190|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455191|NCT00474526|O4|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455192|NCT00474526|O3|Outcome|LA3 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455193|NCT00474526|O2|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455194|NCT00474526|O1|Outcome|LA1 (Men ACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455195|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455196|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455197|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455198|NCT00474526|O1|Outcome|US1 (Men ACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455199|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455200|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455201|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455202|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455203|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455204|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455205|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455206|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455397|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455398|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455207|NCT00474526|O2|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455208|NCT00474526|O1|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455209|NCT00474526|O2|Outcome|US2 (Infant Vaccines Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455210|NCT00474526|O1|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and received,as part of routine infant vaccination schedule, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group US1 was randomized into subgroups US1A and US1B.
455211|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
455212|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
455213|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
455214|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
455215|NCT00474526|O4|Outcome|LA4+LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
455216|NCT00474526|O3|Outcome|LA3+LA5 (Men ACWY-CRM + Infant Vaccines)|"LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
455217|NCT00474526|O2|Outcome|US2+US4 (Infant Vaccines Only)|Groups Infant Vaccines only (US2+US4) pooled US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B) or one dose of MenACWY at 18 months of age (US4C).
455218|NCT00474526|O1|Outcome|US1+US3 (Men ACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
455234|NCT00474526|O6|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455399|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455400|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455219|NCT00474526|O4|Outcome|LA4 + LA6 (Infant Vaccines Only)|"Groups Infant Vaccines only (LA4 and LA6) pooled.~LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received either:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age (LA4).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
455220|NCT00474526|O3|Outcome|LA3 + LA5 (Men ACWY-CRM + Infant Vaccines)|"Groups Men ACWY-CRM + Infant Vaccines (LA3 and LA5) pooled.~LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age these infants were:~Recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib (LA3A)~Received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY (LA3B).~Received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V (LA5)."
455221|NCT00474526|O2|Outcome|US2 + US4 (Infant Vaccines Only)|"Groups Infant Vaccines only (US2+US4) pooled~US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~either one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age (US2 and US4A); or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and one dose at 15 months of age (US4B); or one dose of MenACWY at 18 months of age (US4C)."
455222|NCT00474526|O1|Outcome|US1 + US3 (Men ACWY-CRM + Infant Vaccines)|"Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled.~US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B)."
455223|NCT00474526|O4|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
455224|NCT00474526|O3|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455225|NCT00474526|O2|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
455226|NCT00474526|O1|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455227|NCT00474526|O13|Outcome|LA6C (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
455228|NCT00474526|O12|Outcome|LA6B (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
455229|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455230|NCT00474526|O10|Outcome|LA3B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, received pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received DTaP and Hib. At 17 months of age, these subjects received the fourth dose of MenACWY.
455231|NCT00474526|O9|Outcome|LA3A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Around 12 months of age, these infants were recommended to receive pneumococcal conjugate vaccine, HAV, and MMR-V. At 16 months of age, these subjects received the fourth dose of MenACWY along with concomitant DTaP and Hib.
455232|NCT00474526|O8|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455233|NCT00474526|O7|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455459|NCT00474045|B3|Baseline|Total|Total of all reporting groups
458650|NCT00465101|O7|Outcome|4 Years|
455235|NCT00474526|O5|Outcome|US4C (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
455236|NCT00474526|O4|Outcome|US4B (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 13 and one dose at 15 months of age.
455237|NCT00474526|O3|Outcome|US2 + US4A (Infant Vaccines Only)|Groups Infant Vaccines only (US2 and US4A) pooled. In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455238|NCT00474526|O2|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled.In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455239|NCT00474526|O1|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455240|NCT00474526|O11|Outcome|LA6B + LA6C (Infant Vaccines Only)|"Groups Infant Vaccines only LA6B and LA6C pooled.~Infant Vaccines only (LA6B): LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (LA6B) or one dose of MenACWY at 18 months of age (LA6C)."
455241|NCT00474526|O10|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455242|NCT00474526|O9|Outcome|LA2 + LA4 + LA6A (Infant Vaccines Only)|Groups Infant Vaccines only (LA2, LA4 and LA6A) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455243|NCT00474526|O8|Outcome|LA1B (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a third dose of MenACWY at 13 months of age.
455244|NCT00474526|O7|Outcome|LA1A (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received a third dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455245|NCT00474526|O6|Outcome|US4B + US4C (Infant Vaccines Only)|"Groups Infant Vaccines only (US4B and US4C) pooled.~Infant Vaccines only (US4B): US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and either received one dose of MenACWY at 13 and and a second dose of MenACWY at 15 months of age (US4B); or one dose at 18 months of age (US4C)."
455246|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455247|NCT00474526|O4|Outcome|US2 + US4A (Infant Vaccines Only)|"Groups Infant Vaccines only (US2 and US4A) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age."
455248|NCT00474526|O3|Outcome|US1A + US3 (MenACWY-CRM + Infant Vaccines)|Groups MenACWY-CRM + infant vaccines (US1A and US3) Pooled. In both groups US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455249|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455250|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455251|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
455252|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455253|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455254|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455255|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455256|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455257|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
455258|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455259|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455260|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455261|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455262|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455263|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455264|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines )|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455265|NCT00474526|O10|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
455266|NCT00474526|O9|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455267|NCT00474526|O8|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455268|NCT00474526|O7|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455269|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
455270|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455271|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455272|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
458651|NCT00465101|O6|Outcome|3 Year|
455273|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455274|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455275|NCT00474526|O12|Outcome|LA6 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. Group LA6 was further randomized into LA6A and LA6B and LA6C subgroups.
455276|NCT00474526|O11|Outcome|LA5 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. At 12 months of age, these subjects received the fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V.
455277|NCT00474526|O10|Outcome|LA4 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY along with DTaP and Hib vaccines at 15 months of age.
455278|NCT00474526|O9|Outcome|LA3 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine. Group LA3 was further randomized into LA3A and LA3B subgroups.
455279|NCT00474526|O8|Outcome|LA2 (Infant Vaccines Only)|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455280|NCT00474526|O7|Outcome|LA1 (MenACWY-CRM + Infant Vaccines)|LA infants received MenACWY at 2 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. Group LA1 was randomized into LA1A and LA 1B subgroups.
455281|NCT00474526|O6|Outcome|US4 (Infant Vaccines Only )|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age. These infants were randomized in subgroup US4A, US4B and US4C.
455282|NCT00474526|O5|Outcome|US3 (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received fourth dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months of age.
455283|NCT00474526|O4|Outcome|US2 (Infant Vaccines Only)|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age.
455284|NCT00474526|O3|Outcome|US1 (MenACWY-CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age; and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. Group US1 was randomized into US1A and US1B subgroups.
455285|NCT00474526|O2|Outcome|US1B (MenACWY-CRM + Infant Vaccines )|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines. These infants received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a fourth dose of MenACWY at 13 months of age.
455286|NCT00474526|O1|Outcome|US1A (MenACWY-CRM + Infant Vaccines)|US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age.
455287|NCT00474526|O2|Outcome|US2 (Infant Vaccine Only)|received as part of routine infant vaccination schedule DTaP-IPV-HBV,Hib, pneumococcal conjugate vaccine, and rotavirus vaccine at 2, 4 and 6 months of age. At 12 months of age, these subjects received a dose of MenACWY along with concomitant pneumococcal conjugate vaccine, HAV, and MMR-V. At 15 months of age, these subjects received a second dose of MenACWY.
455288|NCT00474526|O1|Outcome|US1A (MenACWY- CRM + Infant Vaccines)|US infants received one dose of MenACWY at 2, 4 and 6 months of age and as part of routine infant vaccination schedule received, DTaP-IPV-HBV, Hib, pneumococcal conjugate vaccine, and rotavirus vaccine.At 12 months of age received fourth dose of MenACWY along with concomitant pneumococcal,HAV, and MMR-V vaccines.
455289|NCT00474526|E6|Reported Event|LA6C|LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus, and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These infants received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and one dose of MenACWY at 18 months of age
455290|NCT00474526|E5|Reported Event|LA2+4+6AB|Groups Infant Vaccines only (LA2, LA4, LA6A and LA6B) pooled. In all groups LA infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants either received: one dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a second dose of MenACWY at 15 months of age (LA2 and LA4) or received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose each of MenACWY at 12 and 15 months of age (LA6A); or one dose each of MenACWY at 13 and 15 months of age (LA6B).
455321|NCT00474487|E1|Reported Event|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455322|NCT00474383|B1|Baseline|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455291|NCT00474526|E4|Reported Event|LA1+LA3+LA5|"Groups Men ACWY-CRM + Infant Vaccines (LA1, LA3 and LA5) pooled~LA infants received MenACWY at 2 and 6 months of age; and DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received at 12 months of age pneumococcal conjugate vaccine, HAV, and MMR-V and concomitant third dose of MenACWY (LA1A) or a third dose of MenACWY at 13 months of age (LA1B).~LA infants received MenACWY, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. At 12 months of age these infants received pneumococcal conjugate vaccine, HAV, and MMR-V and received:~Fourth dose of MenACWY concomitantly with DTaP and Hib at 16 months of age (LA3A)~DTaP and Hib at 16 months and fourth dose of MenACWY at 17 months of age (LA3B).~Concomitantly the fourth dose of MenACWY (LA5)."
455292|NCT00474526|E3|Reported Event|US4C|US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines, at 2, 4 and 6 months of age. These subjects received concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 18 months of age.
455293|NCT00474526|E2|Reported Event|US2+US4A+US4B|"Groups Infant Vaccines only (US2, US4A, and US4B) pooled.~In both groups US infants received as part of routine infant vaccination schedule DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccines at 2, 4 and 6 months of age. These infants received:~One dose of MenACWY concomitantly with pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months; and a second dose of MenACWY at 15 months of age ( US2 and US4A).~Concomitant pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and one dose of MenACWY at 13 and a second dose of MenACWY at 15 months of age (US4B)"
455294|NCT00474526|E1|Reported Event|US1+US3|Groups MenACWY-CRM + Infant Vaccines (US1 +US3) pooled. US infants received MenACWY at 2, 4 and 6 months of age along with routine infant vaccines, DTaP-IPV-HBV, Hib, rotavirus and pneumococcal conjugate vaccine. These infants either received a fourth dose of MenACWY concomitantly with pneumococcal, HAV, and MMR-V vaccines at 12 months of age (US1A and US3) or received pneumococcal conjugate vaccine, HAV, and MMR-V at 12 months and a fourth dose of MenACWY at 13 months of age( US1B).
455295|NCT00474487|B5|Baseline|Total|Total of all reporting groups
455296|NCT00474487|B4|Baseline|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
455297|NCT00474487|B3|Baseline|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
455298|NCT00474487|B2|Baseline|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
455299|NCT00474487|B1|Baseline|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
455300|NCT00474487|P4|Participant Flow|Licensed Polysaccharide Vaccine (56 to 65 Years)|One 0.5 mL dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered subcutaneously(Ages 56 to 65 Years) after reconstitution.
455301|NCT00474487|P3|Participant Flow|Licensed Conjugate Vaccine (19 to 55 Years)|One 0.5 mL dose of the licensed meningococcal ACWY conjugate vaccine was administered intramuscularly (Ages 19 to 55 years).
455302|NCT00474487|P2|Participant Flow|Novartis MenACWY Vaccine (56 to 65 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
455303|NCT00474487|P1|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose (0.5 mL of injectable solution) of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly after reconstitution.
455304|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly.
455305|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455306|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
455307|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455308|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
455309|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455310|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
455311|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455312|NCT00474487|O2|Outcome|Licensed Polysaccharide Vaccine|One dose of the licensed meningococcal ACWY polysaccharide vaccine administered subcutaneously.
455313|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455314|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
455315|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455316|NCT00474487|O2|Outcome|Licensed Conjugate Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
455317|NCT00474487|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455318|NCT00474487|E4|Reported Event|Licensed Polysaccharide Vaccine (56 to 65 Years)|One dose of the licensed meningococcal ACWY polysaccharide vaccine was administered intramuscularly (Ages 56 to 65 Years)
455319|NCT00474487|E3|Reported Event|Licensed Conjugate Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly in ages 19 to 55 years.
455320|NCT00474487|E2|Reported Event|Novartis MenACWY Vaccine (56 to 65 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine was administered intramuscularly.
455361|NCT00474240|E4|Reported Event|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
455323|NCT00474383|P2|Participant Flow|Arbitarone Acetate (Extension)|Participants who received abiraterone acetate 1000 milligram (mg) capsule or tablet orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily in Main study, continued the same treatment until disease progression, death, or end of study (Week 148).
455324|NCT00474383|P1|Participant Flow|Abiraterone Acetate (Main Study)|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycles up to 12 cycles, along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455325|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455326|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455327|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455328|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455329|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455330|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455331|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455332|NCT00474383|O1|Outcome|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455333|NCT00474383|E1|Reported Event|Abiraterone Acetate|Abiraterone acetate 1000 milligram (mg) capsule or tablet was administered orally, once daily continuously in 28-day cycle up to disease progression, death, or end of study (Week 148), along with prednisone/prednisolone 5 mg tablet orally twice daily or dexamethasone 0.5 mg tablet orally once daily.
455334|NCT00474240|B7|Baseline|Total|Total of all reporting groups
455335|NCT00474240|B6|Baseline|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455336|NCT00474240|B5|Baseline|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455337|NCT00474240|B4|Baseline|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
455338|NCT00474240|B3|Baseline|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
455339|NCT00474240|B2|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
455340|NCT00474240|B1|Baseline|Placebo|Placebo capsule taken orally once daily
455341|NCT00474240|P6|Participant Flow|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455342|NCT00474240|P5|Participant Flow|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455343|NCT00474240|P4|Participant Flow|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
455344|NCT00474240|P3|Participant Flow|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
455345|NCT00474240|P2|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
455346|NCT00474240|P1|Participant Flow|Placebo|Placebo capsule taken orally once daily
455347|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455348|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455349|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
455350|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
455351|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
455352|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
455353|NCT00474240|O6|Outcome|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455354|NCT00474240|O5|Outcome|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455355|NCT00474240|O4|Outcome|AEGR-733 10 mg|AEGR-733 10 mg taken orally once daily
455356|NCT00474240|O3|Outcome|AEGR-733 5 mg|AEGR-733 5 mg taken orally once daily
455357|NCT00474240|O2|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg taken orally once daily
455358|NCT00474240|O1|Outcome|Placebo|Placebo capsule taken orally once daily
455359|NCT00474240|E6|Reported Event|AEGR-733 10 mg + Atorvastatin 20 mg|One capsule of AEGR-733 10 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
455360|NCT00474240|E5|Reported Event|AEGR-733 5 mg + Atorvastatin 20 mg|One capsule of AEGR-733 5 mg and 1 capsule of Atorvastatin 20 mg taken orally once daily
458652|NCT00465101|O5|Outcome|2 Years|
455365|NCT00474201|B1|Baseline|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
455366|NCT00474201|P1|Participant Flow|Gemfibrozil (GF) Alone Followed by GF+ Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected to determine gemfibrozil plasma concentrations. These plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameter values such as area under the concentration vs. time curve (AUC). Gemfibrozil PK parameter values were then compared before- and after lopinavir-ritonavir administration.
455367|NCT00474201|O2|Outcome|Gemfibrozil + Lopinavir-ritonavir|After receiving lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days, subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest.
455368|NCT00474201|O1|Outcome|Gemfibrozil Alone (Control Group)|"Subjects received a single 600 mg dose of gemfibrozil and serial blood samples were collected over a 24 hr. post-dose period to determine pharmacokinetic parameter values. Area under the concentrations vs. time curve from time zero to infinity (i.e. total drug exposure) was the primary pharmacokinetic parameter of interest. After completing participation in this control group, each subject crossed over to received lopinavir-ritonavir (400mg/100mg twice daily) for 14.5 days. Therefore, each subject served as their own control. Hence there were two groups of data analyzed, but each group consisted of the same subjects (tested under different conditions)."
455369|NCT00474201|E1|Reported Event|Gemfibrozil (GF) Alone Followed by GF + Lopinavir-ritonavir|Subjects received a single 600 mg dose of gemfibrozil before- and after receiving lopinavir-ritonar 400mg/100mg twice daily, for 14.5 days. After each gemfibrozil dose, blood samples were collected for the determination of gemfibrozil plasma concentrations. The plasma concentrations were then used to determine gemfibrozil pharmacokinetic (PK) parameters values such as area under the concentration vs. time curve (AUC). PK Parameter values were then compared pre- and post lopinavir-ritonavir administration.
455370|NCT00474188|B1|Baseline|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455371|NCT00474188|P1|Participant Flow|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455372|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455373|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455374|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455375|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455376|NCT00474188|O1|Outcome|Lenalidomide in Combination With Dexamethasone|Lenalidomide 25 mg administered orally once daily on Days 1-21 every 28 days, in combination with dexamethasone 40 mg administered orally on Days 1, 8, 15, and 22 of each 28-day cycle.
455377|NCT00474175|B4|Baseline|Total|Total of all reporting groups
455378|NCT00474175|B3|Baseline|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455379|NCT00474175|B2|Baseline|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455380|NCT00474175|B1|Baseline|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455381|NCT00474175|P3|Participant Flow|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455382|NCT00474175|P2|Participant Flow|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455383|NCT00474175|P1|Participant Flow|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455384|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455385|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455386|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455387|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455388|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455389|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455390|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455391|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455392|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455393|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455394|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455401|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455402|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455403|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455404|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455405|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455406|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455407|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455408|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455409|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455410|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455411|NCT00474175|O3|Outcome|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455412|NCT00474175|O2|Outcome|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455413|NCT00474175|O1|Outcome|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455414|NCT00474175|E3|Reported Event|Benzocaine 20%|Single dose of 20% benzocaine gel administered as per product label directions.
455415|NCT00474175|E2|Reported Event|Benzocaine 10%|Single dose of 10% benzocaine gel administered as per product label directions.
455416|NCT00474175|E1|Reported Event|Placebo|Single dose of placebo gel matched to either 10 % or 20 % benzocaine gel administered as per product label directions.
455417|NCT00474123|B3|Baseline|Total|Total of all reporting groups
455418|NCT00474123|B2|Baseline|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455419|NCT00474123|B1|Baseline|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455420|NCT00474123|P2|Participant Flow|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455421|NCT00474123|P1|Participant Flow|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455422|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455423|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455424|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455425|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455426|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455427|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455428|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455429|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455430|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455431|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455432|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455433|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455434|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455435|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455436|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455437|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455438|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455439|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455440|NCT00474123|O2|Outcome|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455441|NCT00474123|O1|Outcome|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455442|NCT00474123|E2|Reported Event|Simvastatin 20mg/Ezetimibe 10 mg|Patients were treated with Simvastatin 20mg/Ezetimibe 10 mgfor 6 weeks
455443|NCT00474123|E1|Reported Event|Simvastatin 80 mg|Patients were treated with simvastatin 80 mg for 6 weeks
455444|NCT00474058|B3|Baseline|Total|Total of all reporting groups
455445|NCT00474058|B2|Baseline|Placebo|Placebo transdermal patch
455446|NCT00474058|B1|Baseline|Rotigotine|Rotigotine transdermal patch
455447|NCT00474058|P2|Participant Flow|Placebo|Placebo transdermal patch
455448|NCT00474058|P1|Participant Flow|Rotigotine|Rotigotine transdermal patch
455449|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
455450|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
455451|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
455452|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
455453|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
455454|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
455455|NCT00474058|O2|Outcome|Placebo|Placebo transdermal patch
455456|NCT00474058|O1|Outcome|Rotigotine|Rotigotine transdermal patch
455457|NCT00474058|E2|Reported Event|Placebo|Placebo transdermal patch
455458|NCT00474058|E1|Reported Event|Rotigotine|Rotigotine transdermal patch
455460|NCT00474045|B2|Baseline|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455461|NCT00474045|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455462|NCT00474045|P2|Participant Flow|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455463|NCT00474045|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455464|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455465|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455466|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455467|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455468|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455469|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455470|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455471|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455472|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455639|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455473|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455474|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455475|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455476|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455477|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455478|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455479|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455480|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455481|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455482|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455483|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455484|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455485|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455640|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
458653|NCT00465101|O4|Outcome|1 Year|
455486|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455487|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455488|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455489|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455490|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455491|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455492|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455493|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455494|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455495|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455496|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455497|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455498|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455641|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455499|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455500|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455501|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455502|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455503|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455504|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455505|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455506|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455507|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455508|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455509|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455510|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455511|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455642|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
458654|NCT00465101|O3|Outcome|6 Months|
455512|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455513|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455514|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455515|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455516|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455517|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455518|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455519|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455520|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455521|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455522|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455523|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455524|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455643|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455525|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455526|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455527|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455528|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455529|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455530|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455531|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455532|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455533|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455534|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455535|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455536|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455537|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455644|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
458655|NCT00465101|O2|Outcome|3 Months|
455538|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455539|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455540|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455541|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455542|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455543|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455544|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455545|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455546|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455547|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455548|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455549|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455550|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455645|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455551|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455552|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455553|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455554|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455555|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455556|NCT00474045|O2|Outcome|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455557|NCT00474045|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455558|NCT00474045|E2|Reported Event|Neutral Protamine Hagedorn (NPH) Insulin|Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455559|NCT00474045|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
455560|NCT00473889|B3|Baseline|Total|Total of all reporting groups
455561|NCT00473889|B2|Baseline|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455562|NCT00473889|B1|Baseline|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455563|NCT00473889|P2|Participant Flow|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455564|NCT00473889|P1|Participant Flow|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455565|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455598|NCT00473824|O2|Outcome|No Civacir (Control)|Observation on standard site specific routine post-tranplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%. Standard post-tranplant therapy includes immunosuppressive agents.
455566|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455567|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455568|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455569|NCT00473889|O2|Outcome|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455570|NCT00473889|O1|Outcome|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455571|NCT00473889|E2|Reported Event|Placebo + Paclitaxel + Carboplatin|Placebo Comparator arm: Placebo capsules once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455572|NCT00473889|E1|Reported Event|Vorinostat + Paclitaxel + Carboplatin|Experimental arm: Vorinostat capsules (400 mg) once daily on Days -4 through 10 of Cycle 1 (25 day treatment cycle) and Days 1 through 14 of each subsequent 21 day treatment cycle; paclitaxel (200 mg/m2) and carboplatin (area under concentration/time curve of 6 mg/min/mL) administered by intravenous (IV) infusion on Day 1 of each treatment cycle.
455573|NCT00473876|B3|Baseline|Total|Total of all reporting groups
455574|NCT00473876|B2|Baseline|Placebo|Matched Placebo for 4 months
455575|NCT00473876|B1|Baseline|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
455576|NCT00473876|P2|Participant Flow|Placebo|Matched Placebo for 4 months
455577|NCT00473876|P1|Participant Flow|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
455578|NCT00473876|O2|Outcome|Placebo|Impact of placebo on VE/VCO2 slope.
455579|NCT00473876|O1|Outcome|Metformin Arm|Assess impact of metformin on submaximal exercise parameters- VE/VCO2 slope (pre-specified end point). The mean VE/VCO2 difference was compared between baseline and after 4 months of metformin.
455580|NCT00473876|O2|Outcome|Placebo|Peak VO2 mean difference between baseline and after 4 months of placebo
455581|NCT00473876|O1|Outcome|Metformin Arm|Peak VO2 mean difference between baseline and after 4 months of metformin was analysed
455582|NCT00473876|E2|Reported Event|Placebo|Matched Placebo for 4 months
455583|NCT00473876|E1|Reported Event|Metformin|Receiving Metformin for 4 months with a target dose of 1000mg twice a day
455584|NCT00473837|B3|Baseline|Total|Total of all reporting groups
455585|NCT00473837|B2|Baseline|Control|Subjects initially treated with Co-artemether or Chloroquine & Sulphadoxine/Pyrimathamine, and then continued on weekly placebo till day 90
455586|NCT00473837|B1|Baseline|Treatment|Subjects initially treated with Co-artemether or Chloroquine &Sulphadoxine/Pyrimathamine, and then continued on weekly chloroquine till day 90
455587|NCT00473837|P2|Participant Flow|Control|Subjects initially treated with Co-artemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly placebo till day 90.
455588|NCT00473837|P1|Participant Flow|Treatment|Subjects initially treated with Corartemether or Cholroquine & Sulphadoxine/Pyrimethamine, and then continued on weekly chloroquine till day 90.
455589|NCT00473837|O2|Outcome|Control|"Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90~Placebo: The placebo is an orange syrup in a 60ml amber coloured glass bottle containing sucrose syrup base. The syrup was prepared by the Pharmacy department of the Royal Victorial Teaching Hospital and Atlantic Pharmaceuticals Limited, Banjul"
455590|NCT00473837|O1|Outcome|Treatment|"Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90~Chloroquine: This is an orange syrup in a 60ml amber coloured glass bottle containing 50mg of chloroquine base per 5mls as the chloroquine phosphate. The syrup was manufactured by Medreich Sterilab Ltd, Avalahalli, Bangalore, India. Chloroquine: weekly treatment of 7.5mg/kg for 90 days"
455591|NCT00473837|E2|Reported Event|Control|Subjects initially treated with Co-arthemeter, and then continued on weekly placebo till day 90
455592|NCT00473837|E1|Reported Event|Treatment|Subjects initially treated with Co-arthemeter, and then continued on weekly chloroquine till day 90
455593|NCT00473824|B3|Baseline|Total|Total of all reporting groups
455594|NCT00473824|B2|Baseline|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
455595|NCT00473824|B1|Baseline|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
455596|NCT00473824|P2|Participant Flow|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
455597|NCT00473824|P1|Participant Flow|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
458656|NCT00465101|O1|Outcome|Baseline|
455599|NCT00473824|O1|Outcome|Civacir Treatment Arm|Subjects received Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight, in addition to their standard site specific routine post-tranplant immunosuppressant therapy.
455600|NCT00473824|E2|Reported Event|No Civacir (Control)|Observation on standard site specific routine post-transplant immunosuppressant therapy without infusions of Hepatitis C Immune Globulin Intravenous (Human) 5%.
455601|NCT00473824|E1|Reported Event|Civacir Treatment Arm|Subjects received standard site specific routine post-transplant immunosuppressant therapy with Hepatitis C Immune Globulin Intravenous (Human) 5% [Civacir], 18 infusions total, per schedule, of Civacir 300 or 400 mg/kg of body weight.
455602|NCT00473746|B6|Baseline|Total|Total of all reporting groups
455603|NCT00473746|B5|Baseline|Phase 2 1000 MG/DAY|Abiraterone acetate
455604|NCT00473746|B4|Baseline|Phase 1 1000 MG/DAY|Abiraterone acetate
455605|NCT00473746|B3|Baseline|Phase 1 750 MG/DAY|Abiraterone acetate
455606|NCT00473746|B2|Baseline|Phase 1 500 MG/DAY|Abiraterone acetate
455607|NCT00473746|B1|Baseline|Phase 1 250 MG/DAY|Abiraterone acetate
455608|NCT00473746|P5|Participant Flow|Phase 2 1000 MG/DAY|Abiraterone acetate
455609|NCT00473746|P4|Participant Flow|Phase 1 1000 MG/DAY|Abiraterone acetate
455610|NCT00473746|P3|Participant Flow|Phase 1 750 MG/DAY|Abiraterone acetate
455611|NCT00473746|P2|Participant Flow|Phase 1 500 MG/DAY|Abiraterone acetate
455612|NCT00473746|P1|Participant Flow|Phase 1 250 MG/DAY|Abiraterone acetate
455613|NCT00473746|O1|Outcome|Phase II Dose Treatment|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
455614|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455615|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455616|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455617|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455618|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455619|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455620|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455621|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455622|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455623|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455624|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
455625|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455626|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455627|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455628|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
455629|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455630|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455631|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455632|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
455633|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455634|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455635|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455636|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
455637|NCT00473746|O4|Outcome|Phase I Dose Escalation (1000mg)|The fourth cohort was a abiraterone acetate 1000 mg/day orally (by mouth), once daily for 28-day treatment periods.
455638|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455646|NCT00473746|O3|Outcome|Phase I Dose Escalation (750mg)|The third cohort was a abiraterone acetate 700 mg/day orally (by mouth), once daily for 28-day treatment periods.
455647|NCT00473746|O2|Outcome|Phase I Dose Escalation (500mg)|The second cohort was a abiraterone acetate 500 mg/day orally (by mouth), once daily for 28-day treatment periods.
455648|NCT00473746|O1|Outcome|Phase I Dose Escalation (250mg)|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods.
455649|NCT00473746|O1|Outcome|Phase II Dose Treatment|Abiraterone acetate 1000 mg daily and concurrent prednisone/prednisolone (5 mg twice daily) or dexamethasone (0.5 mg once daily) under fasted conditions upto 10 cycles of therapy.
455650|NCT00473746|O1|Outcome|Phase I Dose Escalation|The first cohort was a abiraterone acetate 250 mg/day orally (by mouth), once daily for 28-day treatment periods , if no dose limiting toxicity (DLT) was documented at this dose, the dose will be escalated to next dose levels 500, 750, and 1000 mg/day. The dose escalation will continue to a maximum of 1000 mg/day until maximum tolerated dose (MTD) and a recommended Phase II dose was established.
455651|NCT00473746|E5|Reported Event|Phase 2 1000 MG/DAY|Abiraterone acetate
455652|NCT00473746|E4|Reported Event|Phase 1 1000 MG/DAY|Abiraterone acetate
455653|NCT00473746|E3|Reported Event|Phase 1 750 MG/DAY|Abiraterone acetate
455654|NCT00473746|E2|Reported Event|Phase 1 500 MG/DAY|Abiraterone acetate
455655|NCT00473746|E1|Reported Event|Phase 1 250 MG/DAY|Abiraterone acetate
455656|NCT00473655|B4|Baseline|Total|Total of all reporting groups
455657|NCT00473655|B3|Baseline|Placebo|Placebo
455658|NCT00473655|B2|Baseline|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455659|NCT00473655|B1|Baseline|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455660|NCT00473655|P3|Participant Flow|Placebo|Placebo
455661|NCT00473655|P2|Participant Flow|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455662|NCT00473655|P1|Participant Flow|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455663|NCT00473655|O3|Outcome|Placebo|Placebo
455664|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455665|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455666|NCT00473655|O3|Outcome|Placebo|Placebo
455667|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455668|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455669|NCT00473655|O3|Outcome|Placebo|Placebo
455670|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455671|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455672|NCT00473655|O3|Outcome|Placebo|Placebo
455673|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455674|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455675|NCT00473655|O3|Outcome|Placebo|Placebo
455676|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455677|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455678|NCT00473655|O3|Outcome|Placebo|Placebo
455679|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455680|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455681|NCT00473655|O3|Outcome|Placebo|Placebo
455682|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455683|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455684|NCT00473655|O3|Outcome|Placebo|Placebo
455685|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455686|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455687|NCT00473655|O3|Outcome|Placebo|Placebo
455688|NCT00473655|O2|Outcome|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455689|NCT00473655|O1|Outcome|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455690|NCT00473655|E3|Reported Event|Placebo|Placebo
455691|NCT00473655|E2|Reported Event|Rosuvastatin 20 mg|Rosuvastatin 20 mg
455692|NCT00473655|E1|Reported Event|Rosuvastatin 10 mg|Rosuvastatin 10 mg
455693|NCT00473642|B4|Baseline|Total|Total of all reporting groups
455694|NCT00473642|B3|Baseline|Ranibizumab|Ranibizumab monotherapy
455695|NCT00473642|B2|Baseline|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
455696|NCT00473642|B1|Baseline|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
455697|NCT00473642|P3|Participant Flow|Ranibizumab|Ranibizumab monotherapy
455698|NCT00473642|P2|Participant Flow|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
455699|NCT00473642|P1|Participant Flow|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
455700|NCT00473642|O3|Outcome|Ranibizumab|Ranibizumab monotherapy
455701|NCT00473642|O2|Outcome|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
455702|NCT00473642|O1|Outcome|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
455703|NCT00473642|E3|Reported Event|Ranibizumab|Ranibizumab monotherapy
455704|NCT00473642|E2|Reported Event|50% Fluence PDT|Verteporfin at 50% fluence photodynamic therapy combined with ranibizumab
455705|NCT00473642|E1|Reported Event|Standard Fluence PDT|Standard Fluence Photodynamic Therapy combined with ranibizumab
455706|NCT00473590|B3|Baseline|Total|Total of all reporting groups
455707|NCT00473590|B2|Baseline|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455708|NCT00473590|B1|Baseline|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455709|NCT00473590|P2|Participant Flow|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455710|NCT00473590|P1|Participant Flow|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455711|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455712|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455713|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455714|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455715|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455716|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455717|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455718|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455719|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455720|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455721|NCT00473590|O2|Outcome|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455722|NCT00473590|O1|Outcome|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455723|NCT00473590|E2|Reported Event|BORT + BV|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and bevacizumab 15 mg/kg administered by intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. After completion of 8 cycles, participants could continue to receive bevacizumab as monotherapy until disease progression.
455724|NCT00473590|E1|Reported Event|BORT + P|Participants received bortezomib 1.3 mg/m^2 administered as a 3- to 5-second bolus intravenous injection on Days 1, 4, 8, and 11 of a 21-day cycle for a maximum of eight cycles and placebo intravenous infusion on the first day of each 21-day cycle during the blinded treatment phase. At the completion of the 8-cycle treatment phase, participants entered the observation phase until disease progression.
455725|NCT00473564|B1|Baseline|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
455726|NCT00473564|P1|Participant Flow|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
455727|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
455728|NCT00473564|O1|Outcome|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
455729|NCT00473564|E1|Reported Event|TORS Candidates|Participants who consented to undergo transoral robotic-assisted surgery using the da Vinci® Robotic System
455730|NCT00473512|B6|Baseline|Total|Total of all reporting groups
455731|NCT00473512|B5|Baseline|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455732|NCT00473512|B4|Baseline|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455733|NCT00473512|B3|Baseline|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455734|NCT00473512|B2|Baseline|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455735|NCT00473512|B1|Baseline|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455736|NCT00473512|P5|Participant Flow|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455737|NCT00473512|P4|Participant Flow|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455738|NCT00473512|P3|Participant Flow|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455739|NCT00473512|P2|Participant Flow|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455740|NCT00473512|P1|Participant Flow|250 mg/Day|Abiraterone acetate 250 milligram (mg) capsule administered orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study. Participants received MTD (1000 mg) of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455741|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455742|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455743|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455744|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455745|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455746|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455747|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455748|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455749|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455750|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455821|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455751|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455752|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455753|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455754|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455755|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455756|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455757|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455758|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455759|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455760|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455761|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455762|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455763|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455764|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455765|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455766|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455767|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455768|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455769|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455770|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455771|NCT00473512|O5|Outcome|Abiraterone Acetate 2000 mg|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455772|NCT00473512|O4|Outcome|Abiraterone Acetate 1000 mg|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) orally daily given for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455773|NCT00473512|O3|Outcome|Abiraterone Acetate 750 mg|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455774|NCT00473512|O2|Outcome|Abiraterone Acetate 500 mg|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455775|NCT00473512|O1|Outcome|Abiraterone Acetate 250 mg|Abiraterone acetate 250 mg capsule given orally daily for 28-day treatment period to determine the maximum tolerated dose (MTD) in Phase 1 of the study.
455776|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455777|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455778|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455779|NCT00473512|O5|Outcome|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455780|NCT00473512|O4|Outcome|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455822|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
458657|NCT00465101|O2|Outcome|Delayed (15-91 Days)|
455781|NCT00473512|O3|Outcome|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455782|NCT00473512|O2|Outcome|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455783|NCT00473512|O1|Outcome|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455784|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455785|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455786|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455787|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455788|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455789|NCT00473512|O1|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455790|NCT00473512|O2|Outcome|1000 mg AA Therapy|Participants received 1000 mg abiraterone acetate with or without dexamethasone.
455791|NCT00473512|O1|Outcome|1000 mg AA Monotherapy|Participants received 1000 milligram (mg) abiraterone acetate (AA) without dexamethasone.
455792|NCT00473512|E5|Reported Event|2000 mg/Day|Abiraterone acetate 2000 mg capsules (8 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455793|NCT00473512|E4|Reported Event|1000 mg/Day|Abiraterone acetate 1000 mg capsules (4 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455794|NCT00473512|E3|Reported Event|750 mg/Day|Abiraterone acetate 750 mg capsules (3 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455795|NCT00473512|E2|Reported Event|500 mg/Day|Abiraterone acetate 500 mg capsules (2 x 250 mg capsules) administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455796|NCT00473512|E1|Reported Event|250 mg/Day|Abiraterone acetate 250 mg capsule administered orally daily for 28-day treatment period to determine the MTD in Phase 1 of the study. Participants received MTD of abiraterone acetate for 12 cycles (28 day each) in Phase 2 of the study. Dexamethasone 0.5 mg administered orally (if participants have disease progression) daily up to 12 cycles.
455797|NCT00473434|B1|Baseline|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455798|NCT00473434|P1|Participant Flow|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455799|NCT00473434|O9|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455800|NCT00473434|O8|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455801|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455802|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455803|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455804|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455805|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455806|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455807|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455808|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455809|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455810|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455811|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455812|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455813|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455814|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455815|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455816|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455817|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455818|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455819|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455820|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
458658|NCT00465101|O1|Outcome|Peri-Operative (0-14 Days)|
455823|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455824|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455825|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455826|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455827|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455828|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455829|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455830|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455831|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455832|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455833|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455834|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455835|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455836|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455837|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455838|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455839|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455840|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455841|NCT00473434|O11|Outcome|Week 52|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455842|NCT00473434|O10|Outcome|Week 44|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455843|NCT00473434|O9|Outcome|Week 36|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455844|NCT00473434|O8|Outcome|Week 28|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455845|NCT00473434|O7|Outcome|Week 20|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455846|NCT00473434|O6|Outcome|Week 12|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455847|NCT00473434|O5|Outcome|Week 9|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455848|NCT00473434|O4|Outcome|Week 6|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455849|NCT00473434|O3|Outcome|Week 4|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455850|NCT00473434|O2|Outcome|Week 2|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455851|NCT00473434|O1|Outcome|Baseline|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455852|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455853|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455854|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455855|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455856|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455857|NCT00473434|O1|Outcome|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455858|NCT00473434|E1|Reported Event|Paliperidone Extended Release (ER)|Paliperidone ER 3mg or 6mg or 9mg or 12mg once daily for 52 weeks
455859|NCT00473382|B4|Baseline|Total|Total of all reporting groups
455860|NCT00473382|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
455861|NCT00473382|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455862|NCT00473382|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455863|NCT00473382|P3|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455864|NCT00473382|P2|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455865|NCT00473382|P1|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455866|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455882|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
455867|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455868|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455869|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455870|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455871|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455872|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455873|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455874|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455875|NCT00473382|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455876|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455877|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455878|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455879|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455880|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455881|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
458659|NCT00465101|O8|Outcome|5 Years|
455883|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
455884|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
455885|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455886|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455887|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455888|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455889|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455890|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455891|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive Ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455892|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455893|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455894|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455895|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455896|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455897|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455898|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455899|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455916|NCT00473382|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455954|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455955|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455900|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455901|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455902|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455903|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455904|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455905|NCT00473382|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455906|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455907|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455908|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455909|NCT00473382|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
455910|NCT00473382|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
455911|NCT00473382|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
455912|NCT00473382|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455913|NCT00473382|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455914|NCT00473382|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455915|NCT00473382|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455956|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455917|NCT00473382|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
455918|NCT00473382|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
455919|NCT00473330|B4|Baseline|Total|Total of all reporting groups
455920|NCT00473330|B3|Baseline|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
455921|NCT00473330|B2|Baseline|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455922|NCT00473330|B1|Baseline|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 24 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455923|NCT00473330|P3|Participant Flow|Sham Injection/Ranibizumab 0.5 mg|Patients received a sham intravitreal injection monthly for 24 months. Patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455924|NCT00473330|P2|Participant Flow|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455925|NCT00473330|P1|Participant Flow|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months.
455926|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455927|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455928|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455929|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455930|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455931|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455932|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455933|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata. PRN) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
458660|NCT00465101|O7|Outcome|4 Years|
455934|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455935|NCT00473330|O3|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455936|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455937|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455938|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455939|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455940|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455941|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455942|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months.
455943|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455944|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455945|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455946|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455947|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455948|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455949|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455950|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455951|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455952|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455953|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. For 36-month outcome measures, data in this column represents efficacy data at Month 36.
455957|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455958|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455959|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455960|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455961|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455962|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455963|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455964|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455965|NCT00473330|O4|Outcome|Sham Injection/Ranibizumab 0.5 mg|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455966|NCT00473330|O3|Outcome|Sham Injection|Patients randomized to this group received a sham intravitreal injection monthly for 24 months. For 24-month outcome measures, data in this column represents efficacy data at Month 24.
455967|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients randomized to this group received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455968|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients randomized to this group received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. For 24-month outcome measures, data in this column represents efficacy data at Month 24. For 36-month outcome measures, data in this column represents efficacy data at Month 36. For 48-month outcome measures, data in this column represents efficacy data at Month 48 for subjects enrolled in the open-label extension.
455969|NCT00473330|O3|Outcome|Sham Injection|Patients received a sham intravitreal injection monthly for 24 months.
455970|NCT00473330|O2|Outcome|Ranibizumab 0.5 mg|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 24 months.
455971|NCT00473330|O1|Outcome|Ranibizumab 0.3 mg|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 24 months.
456046|NCT00472576|E2|Reported Event|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
456047|NCT00472576|E1|Reported Event|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
455972|NCT00473330|E7|Reported Event|Ranibizumab 0.5 mg - Months 37-60|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455973|NCT00473330|E6|Reported Event|Ranibizumab 0.3 mg - Months 37-60|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455974|NCT00473330|E5|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 37-60|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Patients who had not discontinued treatment by Month 36 could enter the open-label extension phase to receive ranibizumab 0.5 mg as needed (pro re nata [PRN]) for up to 24 additional months. Data in this column represent the safety data during the open-label extension phase (after Month 36).
455975|NCT00473330|E4|Reported Event|Ranibizumab 0.5 mg - Months 0-36|Patients received ranibizumab 0.5 mg monthly administered intravitreally for 36 months.
455976|NCT00473330|E3|Reported Event|Ranibizumab 0.3 mg - Months 0-36|Patients received ranibizumab 0.3 mg monthly administered intravitreally for 36 months.
455977|NCT00473330|E2|Reported Event|Sham Injection/Ranibizumab 0.5 mg - Months 0-36|Patients received a sham intravitreal injection monthly for 24 months. Although still masked, patients who had not discontinued treatment by Month 24 could choose to receive ranibizumab 0.5 mg monthly administered intravitreally for the subsequent 12 months. Data in this column represent the safety data in the sham group during the entire 36 months of the trial; most patients crossed over to receive ranibizumab 0.5 mg monthly in the third year.
455978|NCT00473330|E1|Reported Event|Sham Injection - Months 0-24|Patients received a sham intravitreal injection monthly for 24 months. Data in this column represent the safety data in the sham group during the first 24 months of the trial when patients were receiving only sham injections. Safety data shown here are also included in the Sham/Ranibizumab 0.5 mg - Months 0-36 column.
455979|NCT00473265|B1|Baseline|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455980|NCT00473265|P1|Participant Flow|PTH1-84|participants received PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455981|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455982|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455983|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455984|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455985|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455986|NCT00473265|O1|Outcome|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455987|NCT00473265|E1|Reported Event|PTH1-84|participants recieved PTH1-84 in either 100mcg daily, every other day, or every three days based on investigators clinical judgement
455988|NCT00472849|B3|Baseline|Total|Total of all reporting groups
455989|NCT00472849|B2|Baseline|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
455990|NCT00472849|B1|Baseline|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
455991|NCT00472849|P2|Participant Flow|OFAR (Phase II)|Oxaliplatin 25 mg/m^2 IV per day (Phase I MTD) on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
455992|NCT00472849|P1|Participant Flow|OFAR (Phase I)|Oxaliplatin starting dose 30 mg/m^2/day over 2 hours on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily intravenous (IV) over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
455993|NCT00472849|O1|Outcome|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
455994|NCT00472849|O1|Outcome|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
455995|NCT00472849|E2|Reported Event|OFAR MTD (Phase II)|Oxaliplatin 25 mg/m^2 IV per day MTD on days 1-4 before Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-4. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after fludarabine dose started, on days 2-4. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses). Pegfilgrastim 6 mg subcutaneously once per chemotherapy cycle, approximately 24 hours after last dose of chemotherapy.
455996|NCT00472849|E1|Reported Event|OFAR (Phase I)|Oxaliplatin 30 mg/m^2/day over 2 hours before on days 1-4 Fludarabine. Fludarabine 30 mg/m^2 daily IV over 30 minutes on days 2-3, 2-4, or 2-5 until maximum tolerated dose reached. Cytarabine 500 mg/m^2 daily IV, 2-hour infusion starting 4 hours after first fludarabine dose started, on days 2-3, 2-4, or 2-5, until maximum tolerated dose reached. Rituximab 375 mg/m^2 IV on day 3, course 1 (on day 1, subsequent courses).
455997|NCT00472797|B3|Baseline|Total|Total of all reporting groups
455998|NCT00472797|B2|Baseline|New Formulation of Rebif - Titrated|
455999|NCT00472797|B1|Baseline|New Formulation of Rebif - Non-Titrated|
456000|NCT00472797|P2|Participant Flow|New Formulation of Rebif - Titrated|The new frmulation of rebif is not approved and under investigation in the US
456001|NCT00472797|P1|Participant Flow|New Formulation of Rebif - Non-Titrated|The new formulation of rebif is not approved and under investigation in the US
456002|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456003|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456004|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456005|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456006|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456007|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456008|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456009|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456010|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456011|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456012|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456013|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456014|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456015|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456016|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456017|NCT00472797|O3|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456018|NCT00472797|O2|Outcome|Titrated|New formulation of rebif
456019|NCT00472797|O1|Outcome|Non-Titrated|New formulation of rebif
456020|NCT00472797|O1|Outcome|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456021|NCT00472797|E3|Reported Event|All New Formulation of Rebif Subjects|All subjects combined in Intent to Treat (ITT) Population
456022|NCT00472797|E2|Reported Event|Titrated|New formulation of rebif
456023|NCT00472797|E1|Reported Event|Non-Titrated|New formulation of rebif
456024|NCT00472732|B3|Baseline|Total|Total of all reporting groups
456025|NCT00472732|B2|Baseline|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
456026|NCT00472732|B1|Baseline|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456027|NCT00472732|P2|Participant Flow|Healthy Males or Females Without Known Medical or Metabolic di|Healthy males or females without known medical or metabolic disorder (control group)
456028|NCT00472732|P1|Participant Flow|Female Carriers of Ornithine Transcarbamylase Deficiency (OTCD|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456029|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
456030|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456031|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
456032|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456033|NCT00472732|O2|Outcome|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
456034|NCT00472732|O1|Outcome|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456035|NCT00472732|E2|Reported Event|Healthy Controls|Healthy males or females without known medical or metabolic disorder (control group)
456036|NCT00472732|E1|Reported Event|OTCD Patients|Female carriers of ornithine transcarbamylase deficiency (OTCD) or males with late onset presentation of OTCD
456037|NCT00472576|B3|Baseline|Total|Total of all reporting groups
456038|NCT00472576|B2|Baseline|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
456039|NCT00472576|B1|Baseline|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
456040|NCT00472576|P2|Participant Flow|MK-0657 Then Placebo|Patients receive 4-8 mg of MK-0657 for 12 days, have no treatment for 14 days, then receive placebo for 12 days.
456041|NCT00472576|P1|Participant Flow|Placebo Then MK-0657|Patients receive placebo for 12 days, have no treatment for 14 days, then receive 4-8 mg of MK-0657 for 12 days.
456042|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
456043|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
456044|NCT00472576|O2|Outcome|MK-0657|Patients receive 4 to 8 mg of MK-0657 for 12 days.
456045|NCT00472576|O1|Outcome|Placebo|Patients receive 4 to 8 mg of an inactive equivalent of MK-0657 for 12 days.
458661|NCT00465101|O6|Outcome|3 Years|
456049|NCT00472446|B4|Baseline|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456050|NCT00472446|B3|Baseline|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456051|NCT00472446|B2|Baseline|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456052|NCT00472446|B1|Baseline|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456053|NCT00472446|P4|Participant Flow|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456054|NCT00472446|P3|Participant Flow|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456055|NCT00472446|P2|Participant Flow|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456056|NCT00472446|P1|Participant Flow|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456057|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456058|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456059|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456060|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456104|NCT00470392|B1|Baseline|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
458662|NCT00465101|O5|Outcome|2 Years|
456061|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456062|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456063|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456064|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456065|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456066|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456067|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456068|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456069|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456070|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456071|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456072|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456073|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456074|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456075|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456076|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456077|NCT00472446|O4|Outcome|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456078|NCT00472446|O3|Outcome|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456079|NCT00472446|O2|Outcome|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456080|NCT00472446|O1|Outcome|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456081|NCT00472446|E4|Reported Event|Placebo Cervivcal Block After Surgery|"placebo bilateral superficial cervical block with saline placed after surgery (just after skin closure)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456082|NCT00472446|E3|Reported Event|Placebo Cervivcal Block Before Surgery|"placebo bilateral superficial cervical block placed before surgery (just before skin incision)~placebo bilateral superficial cervical block: 10 ml of saline (the carrier of bupivacaine in the experimental treatment) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456083|NCT00472446|E2|Reported Event|Cervivcal Block After Surgery|"bilateral superficial cervical block placed after surgery (just after skin closure)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456084|NCT00472446|E1|Reported Event|Cervivcal Block Before Surgery|"bilateral superficial cervical block placed before surgery (just before skin incision)~bilateral superficial cervical block: 10 ml of 5% bupivacaine (Carbostesin®) was used for each side.~Along the cranial dorsal edge of the sternocleidomastoid muscle, three deposits of approximately 2.5 ml were injected to anaesthetize the cervical plexus with its nervus transversus colli. To anaesthetize the region of the planned skin incision, the remaining 2·5 ml was injected subcutaneously on each side."
456085|NCT00472420|B1|Baseline|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456122|NCT00470275|E1|Reported Event|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
456123|NCT00470262|B3|Baseline|Total|Total of all reporting groups
456086|NCT00472420|P1|Participant Flow|Rituximab Plus (+) Chemotherapy|"Participants received rituximab, 375 milligrams per square meter (mg/m^2), intravenously (IV), on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or orally (PO), on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, every 12 hours (q12h) on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456087|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456088|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456089|NCT00472420|O1|Outcome|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456090|NCT00472420|E1|Reported Event|Rituximab + Chemotherapy|"Participants received rituximab, 375 mg/m^2, IV, on Day 1 of Cycles 1-8 (21-day cycle). Participants also received 1 of the following chemotherapies:~CHOP, Cycles 1-8: cyclophosphamide, 750 mg/m^2, IV, doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, vincristine, 1.4 mg/m^2, IV, on Day 1 of Cycles 1-8, and methylprednisolone, 16 mg/d, IV or PO, on Days 1-5.~OR Hyper-CVAD/M-A, Cycles 1, 3, 5, and 7: cyclophosphamide, 300 mg/m^2, IV, q12h on Days 2-4; mesna, 600 mg/m^2, IV, 1 hour before the start of cyclophosphamide on Days 2-4; doxorubicin, 50 mg/m^2, IV, or epirubicin, 70 mg/m^2, IV, on Day 5; vincristine, 1.4 mg/m^2, IV, on Days 5 and 12; and dexamethasone, IV or PO, 40 mg/day on Days 2-5 and Days 12-15.~Hyper-CVAD/M-A, Cycles 2, 4, 6, and 8: methotrexate, 200 mg/m^2, IV, followed by 800 mg/m^2, IV, on Day 2; cytarabine, 3000 mg/m^2, IV over 2 hours, q12h on Day 3 (2 doses) or Days 3-4 (4 doses)."
456091|NCT00470418|B3|Baseline|Total|Total of all reporting groups
456092|NCT00470418|B2|Baseline|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
456093|NCT00470418|B1|Baseline|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
456094|NCT00470418|P2|Participant Flow|Placebo|"Placebo: placebo comparator identical in pill size, appearance and number~Subjects with Alzheimer's Disease"
456095|NCT00470418|P1|Participant Flow|NIC5-15|"NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects. Subjects received escalating doses of 1500, 3000 and 5000 mg daily over the course of the study.~Subjects with Alzheimer's Disease"
456096|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
456097|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
456098|NCT00470418|O2|Outcome|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
456099|NCT00470418|O1|Outcome|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
456100|NCT00470418|E2|Reported Event|Placebo|"Subjects with Alzheimer's Disease~Placebo: placebo comparator"
456101|NCT00470418|E1|Reported Event|NIC5-15|"Subjects with Alzheimer's Disease~NIC5-15: a natural product, found in many foods and plants with mild insulin sensitizing effects"
456102|NCT00470392|B3|Baseline|Total|Total of all reporting groups
456103|NCT00470392|B2|Baseline|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456124|NCT00470262|B2|Baseline|Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD|Treatment with Fenofibrate 145 mg PO QD and Pioglitazone 45mg PO QD in subjects with pre diabetes
456125|NCT00470262|B1|Baseline|Fenofibrate 145 mg PO QD|Treatment fenofibrate 145 mg PO QD in subjects with pre diabetes
458663|NCT00465101|O4|Outcome|1 Year|
456105|NCT00470392|P2|Participant Flow|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456106|NCT00470392|P1|Participant Flow|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456107|NCT00470392|O2|Outcome|Clobetasol|"Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.~No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated."
456108|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456109|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
456110|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456111|NCT00470392|O2|Outcome|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point. No synchronized T cell reactivation was observed upon immunohistochemical analysis, nor upon analysis of T cell death associated gene (TDAG) mRNA by PCR, with Clobetasol treatment, so this arm was terminated.
456112|NCT00470392|O1|Outcome|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456113|NCT00470392|E2|Reported Event|Clobetasol|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Clobetasol propionate 0.05% was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456114|NCT00470392|E1|Reported Event|Imiquimod|Each study subject served as his/her own control. For this arm of the study, topical vehicle was applied to one plaque for 5 days. Imiquimod (5% topical cream) was applied to two psoriasis plaques for 5 days. Skin biopsies were taken from half of each of the 3 plaques at specific time points after completion of topical pre-treatment. The other half of the plaques were exposed to UVB light (via Excimer laser). Biopsies were subsequently taken at a specified time point.
456115|NCT00470301|B1|Baseline|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
456116|NCT00470301|P1|Participant Flow|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
456117|NCT00470301|O1|Outcome|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
456118|NCT00470301|E1|Reported Event|Arm I|"See Detailed Description~tipifarnib: Given orally~paclitaxel: Given IV~doxorubicin hydrochloride: Given IV~cyclophosphamide: Given IV~pegfilgrastim: Given SC~conventional surgery: surgical procedures performed on patients~axillary lymph node dissection: correlative study"
456119|NCT00470275|B1|Baseline|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
456120|NCT00470275|P1|Participant Flow|Cytarbine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
456121|NCT00470275|O1|Outcome|Cytarabine|Cytarabine IV every 12 hours days 1-5 of 21 day cycle. Response evaluation after 6 cycles of therapy.
456820|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456126|NCT00470262|P2|Participant Flow|Piolitazone 45 mg PO QD + Fenofibrate 145mg PO QD|Pioglitazone and Fenofibrate: Subjects will be randomized to a combination of both fenofibrate(145mg PO QD) and pioglitazone 45 mg PO QD
456127|NCT00470262|P1|Participant Flow|Fenofibrate|Treatment with fenofibrate 145mg PO QD
456128|NCT00470262|O2|Outcome|Fenofibrate 145mg PO QD + Pioglitazone 45mg PO BID|Treatment with pioglitazone and fenofibrate in subjects with pre diabetes
456129|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
456130|NCT00470262|O2|Outcome|Fenofibrate 145 mg PO QD + Pioglitazone|Treatment with fenofibrate and pioglitazone in subjects with pre diabetes
456131|NCT00470262|O1|Outcome|Fenofibrate 145mg PO QD|Treatment with fenofibrate in subjects with pre diabetes
456132|NCT00470262|E2|Reported Event|Fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD|Treatment with fenofibrate 145 mg PO QD and Pioglitazone 45 mg PO QD in subjects with pre diabetes
456133|NCT00470262|E1|Reported Event|Fenofibrate 145mg PO QD|Treatment with fenofibrate 145 mg PO QD in subjects with pre diabetes
456134|NCT00470184|B1|Baseline|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456135|NCT00470184|P1|Participant Flow|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456136|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456137|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456138|NCT00470184|O1|Outcome|COR (Capecitabine in Combination w/Oxaliplatin & Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456139|NCT00470184|O1|Outcome|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456163|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
458664|NCT00465101|O3|Outcome|6 Months|
456140|NCT00470184|E1|Reported Event|COR(Capecitabine in Combination w/Oxaliplatin and Radiotherapy|"Cycle 1:~Oxaliplatin (Oxa) 85 mg/m2 IV on days (D) 1, 15 29. Capecitabine (Cap) 1250 mg/m2 in 2 divided daily doses P0 or enteral tube on radiation days (Monday- Friday/weekly), and continued until final dose of radiotherapy. Radiation administered as 1.8 Gy in 28 fractions starting on day 1. Four to six weeks after completion of Cycle I chemoradiotherapy, eligible patients will undergo esophagectomy. Cycles 2 and 3: Postoperatively, in the absence of progression, patients will be eligible for cycles 2 and 3. Cycle 2 will commence at minimum 4 to 6 weeks post-operatively, but no later than 12 weeks post-operatively. Cycles 2 and 3 will consist of OXA and CAP in the same dosage as that last administered during cycle 1. During cycles 2 and 3, CAP will be administered on days 1-29 (Monday- Friday/ weekly) and oxaliplatin on days 1, 15, 29. A minimum of 2 weeks is recommended between cycles 2 and 3."
456141|NCT00472303|B3|Baseline|Total|Total of all reporting groups
456142|NCT00472303|B2|Baseline|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456143|NCT00472303|B1|Baseline|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456144|NCT00472303|P3|Participant Flow|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo received 100 mg tapentadol prolonged release (PR) twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456145|NCT00472303|P2|Participant Flow|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456146|NCT00472303|P1|Participant Flow|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456147|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456148|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456149|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456150|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456151|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456152|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456153|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456154|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456155|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
456156|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456157|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456158|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456159|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase
456160|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456161|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456162|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456548|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456164|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456165|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456166|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456167|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456168|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456169|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456170|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456171|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456172|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456173|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456174|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456175|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456176|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456177|NCT00472303|O1|Outcome|Tapentadol Extended Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456178|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456179|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456180|NCT00472303|O5|Outcome|Morphine Controlled Release Maintenance Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456181|NCT00472303|O4|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily in the titration phase. Followed by matching placebo in the maintenance (i.e. randomized withdrawal phase).
456182|NCT00472303|O3|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456183|NCT00472303|O2|Outcome|Morphine Controlled Release Titration Phase|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses
456184|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456185|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456186|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456187|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456188|NCT00472303|O2|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456189|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456190|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456191|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456192|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456193|NCT00472303|O1|Outcome|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456194|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456195|NCT00472303|O3|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456196|NCT00472303|O2|Outcome|Matching Placebo After Tapentadol in the Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456197|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456198|NCT00472303|O1|Outcome|Morphine Controlled Release|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456199|NCT00472303|O1|Outcome|Tapentadol Prolonged Release|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456200|NCT00472303|O3|Outcome|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456201|NCT00472303|O2|Outcome|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456202|NCT00472303|O1|Outcome|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses. The participant continued at the dose that was effective at the end of the Titration Phase.
456203|NCT00472303|E5|Reported Event|Morphine Controlled Release (Maintenance Phase)|Oral Morphine 40 mg to 100 mg twice daily. The dose that was effective at the end of the Titration Phase.
456204|NCT00472303|E4|Reported Event|Matching Placebo After Tapentadol in Titration Phase|Oral Tapentadol 100 mg to 250 mg twice daily. Participants randomized to placebo in the maintenance phase received 100 mg tapentadol prolonged release twice daily for 3 days to taper them off the tapentadol dose they had received in the Titration Phase. From the 4th day (Day 18) all participants received matching placebo in the maintenance (i.e. randomized withdrawal) phase.
456205|NCT00472303|E3|Reported Event|Tapentadol Prolonged Release (Maintenance Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. The participant continued at the dose that was effective at the end of the Titration Phase.
456206|NCT00472303|E2|Reported Event|Morphine Controlled Release (Titration Phase)|Oral Morphine 40 mg to 100 mg twice daily. Capsule taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456207|NCT00472303|E1|Reported Event|Tapentadol Prolonged Release (Titration Phase)|Oral Tapentadol 100 mg to 250 mg twice daily. Tablet taken orally, twice daily, morning & evening with preferably 12 hours (not less than 6 hours) between doses.
456208|NCT00472290|B1|Baseline|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456209|NCT00472290|P1|Participant Flow|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456210|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456211|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456549|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
458665|NCT00465101|O2|Outcome|3 Months|
456212|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456213|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456214|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456215|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456216|NCT00472290|O1|Outcome|Romiplostim|Subjects received subcutaneous dosing at 250, 500, 750, 1000, or 1500 mcg weekly or biweekly, with adjustments based on platelets. Romiplostim is supplied in a 5 mL single use vial as a sterile, white, preservative-free, lyophilized powder.
456217|NCT00472290|E1|Reported Event|Romiplostim|
456218|NCT00472199|B3|Baseline|Total|Total of all reporting groups
456219|NCT00472199|B2|Baseline|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456220|NCT00472199|B1|Baseline|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456221|NCT00472199|P2|Participant Flow|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456222|NCT00472199|P1|Participant Flow|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456223|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456224|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456225|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456226|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456227|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456228|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456229|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456230|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456231|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456232|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456233|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456234|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456235|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456236|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456237|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456238|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456239|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456240|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456241|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456242|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456243|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456244|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456245|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456246|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456247|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456248|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456249|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456250|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456251|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456252|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456253|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456254|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456255|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456256|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
458666|NCT00465101|O1|Outcome|Baseline QoL Score|
456257|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456258|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456259|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456260|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456261|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456262|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456263|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456264|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456265|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456266|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456267|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456268|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456269|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456270|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456271|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456272|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456273|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456274|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456275|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456276|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456277|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456487|NCT00471107|B2|Baseline|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456278|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456279|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456280|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456281|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456282|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456283|NCT00472199|O2|Outcome|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456284|NCT00472199|O1|Outcome|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456285|NCT00472199|E2|Reported Event|Placebo|4 weeks of flexible dose-titration as for the investigational product; with the dose subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456286|NCT00472199|E1|Reported Event|Pramipexole|4 weeks of flexible dose-titration (to optimise efficacy and tolerability), starting at 0.125 mg once daily with the potential to increase the dose to 0.25mg and to further increase or decrease the dose in steps to 0.5 mg and 0.75 mg, with the final dose level subsequently fixed for 22 weeks. mode of administration: Oral, once daily in the evening (2 to 3 hours before bedtime) form: tablets
456287|NCT00472082|B1|Baseline|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
456288|NCT00472082|P1|Participant Flow|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
456289|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
456290|NCT00472082|O1|Outcome|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
456327|NCT00471822|P1|Participant Flow|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456328|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456543|NCT00470600|B1|Baseline|Placebo|250 mL of normal saline.
456291|NCT00472082|E1|Reported Event|Efalizumab Conversion|"The study drug Efalizumab will be given as part of a triple drug regimen including mycophenolate mofetil and prednisone. A test dose of Efalizumab 0.7mg/kg will be given at the enrollment visit. Beginning with study visit 2, Efalizumab 1mg/kg will be administered subcutaneously by injection on a weekly basis for 1 year. Mycophenolate mofetil will be given at a dose of 2gm/day which is the same as the standard of care dose. If patient experiences drug toxicity with mycophenolate mofetil they may be reduced and resume a minimum of at least 1gram daily to continue in the study. Patients will be maintained at 10mg of prednisone daily, same as standard of care.~efalizumab : Administration of a test dose of efalizumab 0.7mg/kg will be administered at enrollment. Weekly subcutaneous injections of efalizumab 1mg/kg will begin with study visit 2 and continue for 1 year for this pilot study."
456292|NCT00472056|B5|Baseline|Total|Total of all reporting groups
456293|NCT00472056|B4|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456294|NCT00472056|B3|Baseline|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456295|NCT00472056|B2|Baseline|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456296|NCT00472056|B1|Baseline|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456297|NCT00472056|P4|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456298|NCT00472056|P3|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456299|NCT00472056|P2|Participant Flow|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456300|NCT00472056|P1|Participant Flow|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456301|NCT00472056|O2|Outcome|High Dose Rituximab|High dose arm: Rituximab 1000mg/m^2 intravenous on days +1 and +8 after stem cell infusion
456302|NCT00472056|O1|Outcome|Standard Dose Rituximab|Standard dose arm: Rituximab 375 mg/m^2 intravenous on days +1 and +8 after stem cell infusion.
456303|NCT00472056|E4|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456304|NCT00472056|E3|Reported Event|Cohort 1 65 Years of Age or Less With Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456305|NCT00472056|E2|Reported Event|Cohort 2 Patients Who Are Older Than 65 Years of Age Arm 1|Arm 1: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + Standard Dose Rituximab
456306|NCT00472056|E1|Reported Event|Cohort 1 65 Years of Age or Less With Arm 2|Arm 2: BEAM Chemotherapy (Carmustine, Etoposide, Cytarabine, Melphalan) + High Dose Rituximab
456307|NCT00472030|B3|Baseline|Total|Total of all reporting groups
456308|NCT00472030|B2|Baseline|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
456309|NCT00472030|B1|Baseline|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
456310|NCT00472030|P2|Participant Flow|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
456311|NCT00472030|P1|Participant Flow|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
456312|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
456313|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
456314|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
456315|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 14 weeks.
456316|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
456317|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
456318|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Research subjects enrolled to the Omalizumab treatment arm will be treated with Omalizumab on Day 1 and at Week 2,4,6,8,10,12,& 14.
456319|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 milligrams per kilogram per day (mg/kg/day).
456320|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with Omalizumab on Day 1, Week 2,4,6,8,10,12 and 14.
456321|NCT00472030|O2|Outcome|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
456322|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
456323|NCT00472030|O1|Outcome|Omalizumab Treatment Arm|Omalizumab 150-375 milligrams (mg) will be administered subcutaneously at Day 1, Week 2,4,6,8,10,12, and 14.
456324|NCT00472030|E2|Reported Event|Prednisone Standard Therapy Treatment Arm|The control arm of the study will receive standard prednisone therapy to a maximum dose of 0.5 mg/kg/day.
456325|NCT00472030|E1|Reported Event|Omalizumab Treatment Arm|Patients with bullous pemphigoid will be treated with omalizumab for a total treatment period of 16 weeks.
456326|NCT00471822|B1|Baseline|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456329|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456330|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456331|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456332|NCT00471822|O1|Outcome|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456333|NCT00471822|E1|Reported Event|All Potential Carriers|Participants with age range of 2 months to 5 years at pediatric clinics in hospitals, day care centers or kindergartens, with potential carriage of streptococcus pneumoniae strains.
456334|NCT00471718|B1|Baseline|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456335|NCT00471718|P1|Participant Flow|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456336|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456337|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
456338|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle.
456339|NCT00471718|O1|Outcome|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456340|NCT00471718|O1|Outcome|Phase I/11: ABT-751|Duration of overall response from time measurements are met for CR or PR until date that recurrence or PD is objectively documented
456341|NCT00471718|O1|Outcome|ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456342|NCT00471718|E1|Reported Event|Phase I/II: ABT-751|Phase I: Patients receive oral ABT-751 twice daily on days 1-7 and 15-21. Phase II: Patients receive ABT-751 at 125mg twice daily, 7 days on, 7 days off (x2)for a 28-day cycle
456343|NCT00471705|B4|Baseline|Total|Total of all reporting groups
456344|NCT00471705|B3|Baseline|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456345|NCT00471705|B2|Baseline|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456346|NCT00471705|B1|Baseline|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456347|NCT00471705|P3|Participant Flow|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456348|NCT00471705|P2|Participant Flow|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456349|NCT00471705|P1|Participant Flow|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456350|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456351|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456352|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456353|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456354|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456355|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456356|NCT00471705|O3|Outcome|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456357|NCT00471705|O2|Outcome|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456358|NCT00471705|O1|Outcome|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456359|NCT00471705|E3|Reported Event|Thermotherapy|One session of local heat using a thermotherapy device at 50 celsius degrees during 30 seconds.
456360|NCT00471705|E2|Reported Event|Glucantime®|Glucantime® 20 mg /Kg /day for 20 days (intramuscular)
456361|NCT00471705|E1|Reported Event|Miltefosine|Miltefosine 2.5 mg/Kg/day with a maximum dose of 150 mg PO day.
456362|NCT00471536|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456363|NCT00471536|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456364|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456365|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456366|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456367|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456644|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects.
456368|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456369|NCT00471536|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456370|NCT00471536|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive oral pazopanib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
456371|NCT00471497|B4|Baseline|Total|Total of all reporting groups
456372|NCT00471497|B3|Baseline|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456373|NCT00471497|B2|Baseline|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456374|NCT00471497|B1|Baseline|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
456375|NCT00471497|P3|Participant Flow|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456376|NCT00471497|P2|Participant Flow|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456377|NCT00471497|P1|Participant Flow|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
456378|NCT00471497|O3|Outcome|Nilotinib 400mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456379|NCT00471497|O2|Outcome|Nilotinb 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456380|NCT00471497|O1|Outcome|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
456381|NCT00471497|E3|Reported Event|Nilotinib 400 mg BID|Patients who were randomized to this arm were to receive nilotinib 400 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456382|NCT00471497|E2|Reported Event|Nilotinib 300 mg BID|Patients who were randomized to this arm were to receive nilotinib 300 mg twice a day (BID) by mouth each morning and evening approximately 12 hours apart. If the morning or evening dose was delayed for more than 4 hours, the patient was to skip this dose and resume dosing with the next dose as per the original schedule in order to prevent overdosing. No imatinib washout period was necessary prior to administration of nilotinib. Nilotinib was not to be taken with food. No food was to be consumed for at least 2 hours before the dose was taken and no additional oral intake other than water was to be consumed for at least one hour after the dose was taken. Patients were instructed to swallow capsules whole with a full 8 ounce glass of water, and not to chew them. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits. Vomited doses were not to be repeated.
456383|NCT00471497|E1|Reported Event|Imatinib 400 mg QD|Patients randomized to this arm were to receive 400 mg imatinib once a day (QD). If the patient required a dose escalation from 400 mg/day, the patient was to receive 400 mg imatinib twice daily orally. Imatinib was taken with food and a large glass of water. All patients were to avoid grapefruit, star fruit, pomegranate and Seville oranges or juices and products containing these fruits during the study. In cases of vomiting doses were not to be repeated.
456384|NCT00471445|B3|Baseline|Total|Total of all reporting groups
456385|NCT00471445|B2|Baseline|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
456386|NCT00471445|B1|Baseline|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
456387|NCT00471445|P2|Participant Flow|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
456388|NCT00471445|P1|Participant Flow|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
456389|NCT00471445|O2|Outcome|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
456390|NCT00471445|O1|Outcome|Ketamine/Amitriptyline NP-H Cream|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
456391|NCT00471445|E2|Reported Event|Placebo Cream|"Patients apply a placebo cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~placebo: Applied topically"
456392|NCT00471445|E1|Reported Event|Amitriptyline and Ketamine Hydrochloride Topical Analgesic cr|"Patients apply amitriptyline and ketamine hydrochloride topical analgesic cream twice daily to areas of pain, numbness, or tingling in the hands and/or feet.~ketamine/amitriptyline NP-H cream: Applied topically"
456393|NCT00471380|B1|Baseline|Overall Study Population|
456394|NCT00471380|P2|Participant Flow|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
456395|NCT00471380|P1|Participant Flow|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
456396|NCT00471380|O2|Outcome|Crossover Group BAA|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 1 (8 weeks). Then participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks).
456397|NCT00471380|O1|Outcome|Crossover Group ABB|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.) for period 1 for 8 weeks. Then participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.) for Period 2 (8 weeks) and Period 3 (8 weeks)
456398|NCT00471380|E2|Reported Event|Treatment B|Participants received Treatment B, which was fixed combination of timolol 0.5% and dorzolamide 2% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.), and travoprost vehicle (ophthalmic drops, 1 drop/eye, at approximately 19:45 p.m.).
456399|NCT00471380|E1|Reported Event|Treatment A|Participants received Treatment A, which was concomitant administration of travoprost 0.004% (ophthalmic drops, 1 drop/eye at approximately 19:45 p.m.) and brinzolamide 1% (ophthalmic drops, 1 drop/eye, at 08:00 a.m. and at 20:00 p.m.).
456400|NCT00471354|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456401|NCT00471354|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456402|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456403|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456404|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456405|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456406|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456407|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456408|NCT00471354|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456409|NCT00471354|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD), by mouth (PO), starting dose titrated over 1 week to target dose 1.2 mg/kg/day QD, PO for 23 weeks.
456410|NCT00471328|B3|Baseline|Total|Total of all reporting groups
456411|NCT00471328|B2|Baseline|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456412|NCT00471328|B1|Baseline|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456413|NCT00471328|P2|Participant Flow|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456414|NCT00471328|P1|Participant Flow|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456415|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456416|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456417|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456418|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456419|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456420|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456421|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456422|NCT00471328|O1|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression and cross-overed to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456423|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456424|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456544|NCT00470600|P2|Participant Flow|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456425|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456426|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456427|NCT00471328|O2|Outcome|Control/Cross Over to Nilotinib|"In core study phase, patients in this arm received Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose or at the investigator's choice until documented disease progression followed by cross-over to nilotinib arm.~Patients entering the extension study on this control arm were permitted to cross over to nilotinib arm only upon documented disease progression."
456428|NCT00471328|O1|Outcome|Nilotinib|400 mg was taken orally twice daily in core and extension phase of the study
456429|NCT00471328|E3|Reported Event|Crossover Nilotinib Therapy|All patients who crossed over from control arm to nilotinib after completing the Core study or during the Extension study after disease progression were included in safety assessment.
456430|NCT00471328|E2|Reported Event|Control(Core + Extension)|Patients randomized to control arm, Best Supportive Care (BSC) with or without imatinib or sunitinib at the last tolerated dose before the study or at the dose of the investigator’s choice. The safety is assessed using these patient’s data from both core and extension phase of the study.
456431|NCT00471328|E1|Reported Event|Nilotinib(Core +Extension)|Patients randomized to 400 mg Nilotinib which was taken orally twice daily. The safety is assessed using these patient’s data from both core and extension phase of the study.
456432|NCT00471315|B1|Baseline|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
456433|NCT00471315|P1|Participant Flow|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
456434|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
456435|NCT00471315|O1|Outcome|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
456436|NCT00471315|E1|Reported Event|Duloxetine|Duloxetine orally in a dose of 30 mg/day in AM for the first week and 60 mg/day in AM thereafter.
456437|NCT00471276|B1|Baseline|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456438|NCT00471276|P1|Participant Flow|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456439|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456440|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456441|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456442|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456443|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456444|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456445|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456446|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456447|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456448|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456449|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456450|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456451|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456452|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456453|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456486|NCT00471107|B3|Baseline|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
456454|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456455|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456456|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456457|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456458|NCT00471276|O1|Outcome|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456459|NCT00471276|E1|Reported Event|Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule in continuous daily dose (CDD) schedule. Dose adjustments, if needed, included a reduction to 25mg daily or escalation to 50mg daily anytime after Week 12.
456460|NCT00471146|B3|Baseline|Total|Total of all reporting groups
456461|NCT00471146|B2|Baseline|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456462|NCT00471146|B1|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456463|NCT00471146|P2|Participant Flow|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456464|NCT00471146|P1|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) in cycles of 4 weeks. Gemcitabine 1000 mg per square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456465|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456466|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456467|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456468|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456469|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456470|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456471|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456472|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456473|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456474|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456475|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456476|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456477|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456478|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456479|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456480|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456481|NCT00471146|O2|Outcome|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456482|NCT00471146|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456483|NCT00471146|E2|Reported Event|Placebo + Gemcitabine|Placebo matched to axitinib 5 mg tablet orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456484|NCT00471146|E1|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) tablet 5 mg orally BID in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
456485|NCT00471107|B4|Baseline|Total|Total of all reporting groups
456545|NCT00470600|P1|Participant Flow|Placebo|250 mL of normal saline.
456488|NCT00471107|B1|Baseline|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456489|NCT00471107|P3|Participant Flow|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
456490|NCT00471107|P2|Participant Flow|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456491|NCT00471107|P1|Participant Flow|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456492|NCT00471107|O3|Outcome|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
456493|NCT00471107|O2|Outcome|Left Prefrontal Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456494|NCT00471107|O1|Outcome|Left Prefrontal Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456495|NCT00471107|E3|Reported Event|Sham TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) sham stimulation during verbal memory tasks.
456496|NCT00471107|E2|Reported Event|Cathodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) cathodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456497|NCT00471107|E1|Reported Event|Anodal TDCS|Randomly selected healthy volunteers undergoing left dorsolateral prefrontal cortex (LDPFC) anodal transcranial direct current stimulation (tDCS) during verbal memory tasks.
456498|NCT00471068|B3|Baseline|Total|Total of all reporting groups
456499|NCT00471068|B2|Baseline|Cosopt|
456500|NCT00471068|B1|Baseline|Travatan|
456501|NCT00471068|P2|Participant Flow|Cosopt|
456502|NCT00471068|P1|Participant Flow|Travatan|
456503|NCT00471068|O2|Outcome|Cosopt|
456504|NCT00471068|O1|Outcome|Travatan|
456505|NCT00471068|E2|Reported Event|Cosopt|
456506|NCT00471068|E1|Reported Event|Travatan|
456507|NCT00470847|B1|Baseline|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456508|NCT00470847|P1|Participant Flow|Lapatinib,Whole Brain Radiation,Herceptin|Participants received lapatinib, orally, 750mg twice on day one followed by 1000mg, 1250mg, or 1500mg once daily. Whole Brain Radiation therapy (WBRT) (37.5 Gy, 15 fractions) began 1-8 days after starting lapatinib. Lapatinib was continued through WBRT. Following WBRT, patients received trastuzumab intravenously 2mg/kg weekly and lapatinib 1000mg orally once daily.
456509|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456510|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456511|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456512|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456513|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456514|NCT00470847|O1|Outcome|Lapatinib,Whole Brain Radiation,Herceptin|Lapatinib before and during Whole Brain Radiation Therapy (WBRT), then Herceptin 4mg/kg IV weekly
456515|NCT00470847|E3|Reported Event|Dose Level 3|n=5 participants 1500 mg lapatinib daily
456516|NCT00470847|E2|Reported Event|Dose Level 1|n=3 participants 1000 mg lapatinib daily
456517|NCT00470847|E1|Reported Event|Dose Level 2|n=27 participants Maximum Tolerated Dose 1250 mg lapatinib daily
456518|NCT00470834|B3|Baseline|Total|Total of all reporting groups
456519|NCT00470834|B2|Baseline|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456520|NCT00470834|B1|Baseline|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456521|NCT00470834|P2|Participant Flow|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456522|NCT00470834|P1|Participant Flow|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456546|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456523|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456524|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456525|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456526|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456527|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456528|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456529|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456530|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456531|NCT00470834|O2|Outcome|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456532|NCT00470834|O1|Outcome|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456533|NCT00470834|E2|Reported Event|Bicalutamide 50 mg/Dutasteride 3.5 mg|Participants were randomly assigned to receive oral bicalutamide 50 mg and dutasteride 3.5 mg once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase, during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456534|NCT00470834|E1|Reported Event|Bicalutamide 50 mg/Placebo|Participants were randomly assigned to receive oral bicalutamide 50 milligrams (mg) and matching placebo once daily for 18 months. Participants who completed the 18-month treatment period with either stabilization or a positive response to their prostate cancer were offered participation in the 2-year extension phase , during which they would remain on their current treatment. A safety follow-up was conducted 16 weeks (+/-7 days) after withdrawal from investigational product (end of treatment or early withdrawal).
456535|NCT00470626|B1|Baseline|Celect Vena Cava Filter|
456536|NCT00470626|P1|Participant Flow|Celect Vena Cava Filter|
456537|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
456538|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
456539|NCT00470626|O1|Outcome|Celect Vena Cava Filter|
456540|NCT00470626|E1|Reported Event|Celect Vena Cava Filter|
456541|NCT00470600|B3|Baseline|Total|Total of all reporting groups
456542|NCT00470600|B2|Baseline|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456550|NCT00470600|O2|Outcome|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456551|NCT00470600|O1|Outcome|Placebo|250 mL of normal saline.
456552|NCT00470600|E2|Reported Event|800mg IV Ibuprofen (Caldolor)|8 mL of IV Ibuprofen (Caldolor) added with 250 mL of normal saline to give 800 mg dose.
456553|NCT00470600|E1|Reported Event|Placebo|250 mL of normal saline.
456554|NCT00470535|B1|Baseline|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456555|NCT00470535|P1|Participant Flow|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456556|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456557|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456558|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456559|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456560|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456561|NCT00470535|O1|Outcome|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456562|NCT00470535|E1|Reported Event|Erlotinib (Tarceva)|Erlotinib 150mg orally daily for three weeks
456563|NCT00470470|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
456564|NCT00470470|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
456565|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
456566|NCT00470470|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
456567|NCT00470470|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|"Patients receive oral imatinib mesylate 400 mg twice daily for up to 12 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
456568|NCT00470158|B6|Baseline|Total|Total of all reporting groups
456569|NCT00470158|B5|Baseline|Placebo|placebo daily
456570|NCT00470158|B4|Baseline|Zinc Alone|zinc, alternating daily with placebo
456571|NCT00470158|B3|Baseline|Iron Alone|iron, alternating daily with placebo
456572|NCT00470158|B2|Baseline|Separate Iron and Zinc|iron, alternating daily with zinc
456573|NCT00470158|B1|Baseline|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
456574|NCT00470158|P5|Participant Flow|Placebo|placebo daily
456575|NCT00470158|P4|Participant Flow|Zinc Alone|zinc, alternating daily with placebo
456576|NCT00470158|P3|Participant Flow|Iron Alone|iron, alternating daily with placebo
456577|NCT00470158|P2|Participant Flow|Separate Iron and Zinc|iron, alternating daily with zinc
456578|NCT00470158|P1|Participant Flow|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
456579|NCT00470158|O5|Outcome|Placebo|placebo daily
456580|NCT00470158|O4|Outcome|Zinc Alone|zinc, alternating daily with placebo
456581|NCT00470158|O3|Outcome|Iron Alone|iron, alternating daily with placebo
456582|NCT00470158|O2|Outcome|Separate Iron and Zinc|iron, alternating daily with zinc
456583|NCT00470158|O1|Outcome|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
456584|NCT00470158|E5|Reported Event|Placebo|placebo daily
456585|NCT00470158|E4|Reported Event|Zinc Alone|zinc, alternating daily with placebo
456586|NCT00470158|E3|Reported Event|Iron Alone|iron, alternating daily with placebo
456587|NCT00470158|E2|Reported Event|Separate Iron and Zinc|iron, alternating daily with zinc
456588|NCT00470158|E1|Reported Event|Combined Iron and Zinc|combined iron and zinc, alternating daily with placebo
456589|NCT00470106|B5|Baseline|Total|Total of all reporting groups
456590|NCT00470106|B4|Baseline|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
456591|NCT00470106|B3|Baseline|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
456592|NCT00470106|B2|Baseline|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
456593|NCT00470106|B1|Baseline|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
456594|NCT00470106|P4|Participant Flow|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
456595|NCT00470106|P3|Participant Flow|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
456596|NCT00470106|P2|Participant Flow|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
456597|NCT00470106|P1|Participant Flow|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
456598|NCT00470106|O4|Outcome|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
456599|NCT00470106|O3|Outcome|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
456600|NCT00470106|O2|Outcome|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
456601|NCT00470106|O1|Outcome|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
459188|NCT00464087|B4|Baseline|Total|Total of all reporting groups
456602|NCT00470106|O4|Outcome|Skills Training|"control training~skills training: Skills training in how to identify symptoms of illness and medication side effects."
456603|NCT00470106|O3|Outcome|Hybrid Intervention|"combined social cognitive and cognitive remediation training~hybrid intervention: A combination of the two groups listed above."
456604|NCT00470106|O2|Outcome|Cognitive Remediation|"cognitive remediation~Cognitive remediation: Computer exercises in attention, memory, and speed of processing."
456605|NCT00470106|O1|Outcome|Social Cognitive Skills Training|"social cognitive skills training~Social Cognitive skills training: Group training on emotion perception, social perception, and understanding others' mental states."
456606|NCT00470106|E4|Reported Event|Control - Social Skills Training|This group was a control for the amount of time in sessions. There was no social cognitive training.
456607|NCT00470106|E3|Reported Event|Hybrid Group|Half of the sessions were cognitive remediation and half were social cognitive training.
456608|NCT00470106|E2|Reported Event|Cognitive Remediation|Cognitive remediation: Computer exercises in attention, memory, and speed of processing.
456609|NCT00470106|E1|Reported Event|Social Cognition|Social Cognitive remediation: Group training on emotion perception, social perception, and understanding others' mental states.
456610|NCT00470067|B1|Baseline|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
456611|NCT00470067|P1|Participant Flow|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
456612|NCT00470067|O1|Outcome|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
456613|NCT00470067|E1|Reported Event|Doxorubicin and Carboplatin|"Patients receive doxorubicin hydrochloride liposome IV over 1 hour on day 1 and carboplatin IV over 30 minutes on day 1~carboplatin: IV~pegylated liposomal doxorubicin hydrochloride: IV"
456614|NCT00470054|B1|Baseline|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456615|NCT00470054|P1|Participant Flow|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456616|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456617|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456618|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456619|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456620|NCT00470054|O1|Outcome|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456621|NCT00470054|E1|Reported Event|Dasatinib|Pts receive oral dasatinib 70 mg twice daily
456622|NCT00469898|B1|Baseline|Therapeutic Intervention|
456623|NCT00469898|P1|Participant Flow|Therapeutic Intervention|
456624|NCT00469898|O1|Outcome|Therapeutic Intervention|
456625|NCT00469898|O1|Outcome|Therapeutic Intervention|
456626|NCT00469898|O1|Outcome|Therapeutic Intervention|
456627|NCT00469898|O1|Outcome|Therapeutic Intervention|
456628|NCT00469898|E1|Reported Event|Therapeutic Intervention|
456629|NCT00469859|B3|Baseline|Total|Total of all reporting groups
456630|NCT00469859|B2|Baseline|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456631|NCT00469859|B1|Baseline|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456632|NCT00469859|P2|Participant Flow|Group 2 (Lestaurtinib: Dose 62.5 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)~cytarabine"
456645|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects
456646|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled Type 2 diabetic subjects
456647|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled type 2 diabetic subjects.
456648|NCT00469833|O1|Outcome|Oral Glucose|Oral glucose administered to uncontrolled type 2 diabetic subjects.
456633|NCT00469859|P1|Participant Flow|Group 1 (Lestaurtinib Dose 50 mg/m2)|"COURSE 1: Cytarabine IV over 2 hours twice daily days 1-4, idarubicin IV over 15 minutes days 2-4, and oral lestaurtinib twice daily days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a safe, tolerable and biologically active dose (TBAD) is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456634|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456635|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456636|NCT00469859|O2|Outcome|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456637|NCT00469859|O1|Outcome|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456638|NCT00469859|E2|Reported Event|Group 2 (Lestaurtinib: Dose 62.5 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456639|NCT00469859|E1|Reported Event|Group 1 (Lestaurtinib Dose 50 mg/m2|"COURSE 1: Patients receive cytarabine IV over 2 hours twice daily on days 1-4, idarubicin IV over 15 minutes on days 2-4, and oral lestaurtinib twice daily on days 5-28. Patients achieving complete or partial response proceed to course 2. Cohorts of 6 patients receive escalating doses of lestaurtinib until a TBAD is determined. The TBAD is defined as the dose at which no more than 2 of 6 patients experience DLT and biologic activity is confirmed by PIA assay.~COURSE 2: Patients receive high-dose cytarabine IV over 3 hours twice daily on days 1-4 and oral lestaurtinib (at the dose determined in course 1) twice daily on days 5-28. Patients achieving complete or partial response proceed to continuation therapy.~CONTINUATION THERAPY: Patients receive oral lestaurtinib twice daily on days 1-28. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Continued (see detailed description)"
456640|NCT00469833|B1|Baseline|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
456641|NCT00469833|P1|Participant Flow|Uncontrolled Type 2 Diabetic Subjects|Eligible subjects will have measures of insulin secretion measured using the OGTT/hyperglycemic clamp technique before and after 2 months of treatment to lower blood glucose.
456642|NCT00469833|O1|Outcome|Uncontrolled Type 2 Diabetic Subjects|
456643|NCT00469833|O2|Outcome|IV Glucose|IV glucose administered to uncontrolled Type 2 diabetic subjects.
456649|NCT00469833|E1|Reported Event|Arm 1|"Within subjects comparison; before and after treatment.~Beta-cell function measured with OGTT/hyperglycemic clamp"
456650|NCT00469508|B3|Baseline|Total|Total of all reporting groups
456651|NCT00469508|B2|Baseline|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456652|NCT00469508|B1|Baseline|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456653|NCT00469508|P2|Participant Flow|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456654|NCT00469508|P1|Participant Flow|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456655|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456656|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456657|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456658|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456659|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456660|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456661|NCT00469508|O2|Outcome|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456662|NCT00469508|O1|Outcome|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456663|NCT00469508|E2|Reported Event|Placebo|Modafinil 0mg (sugar pill) oral dose taken daily for 12 weeks
456664|NCT00469508|E1|Reported Event|Modafinil|Modafinil 400mg oral dose taken daily for 12 weeks
456665|NCT00469456|B3|Baseline|Total|Total of all reporting groups
456666|NCT00469456|B2|Baseline|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
456667|NCT00469456|B1|Baseline|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
456668|NCT00469456|P2|Participant Flow|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
456669|NCT00469456|P1|Participant Flow|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
456670|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
456671|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
456672|NCT00469456|O2|Outcome|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
456673|NCT00469456|O1|Outcome|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
456674|NCT00469456|E2|Reported Event|Memantine|Memantine 20mg (10mg twice daily), oral administration for 12 weeks
456675|NCT00469456|E1|Reported Event|Placebo|Matching placebo, oral administration, twice daily for 12 weeks
456676|NCT00469391|B3|Baseline|Total|Total of all reporting groups
456677|NCT00469391|B2|Baseline|Sham Control|Sham Procedure: Weight loss
456678|NCT00469391|B1|Baseline|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
456679|NCT00469391|P2|Participant Flow|Sham Control|Sham Procedure followed by standard-of-care diet therapy
456680|NCT00469391|P1|Participant Flow|GI Sleeve|GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss followed by standard-of-care diet therapy
456681|NCT00469391|O2|Outcome|Sham Control|Sham Procedure: Weight loss
456682|NCT00469391|O1|Outcome|GI Sleeve|"medical device that mimics gastric bypass mechanism for weight-loss~GI Sleeve Implantable weight loss device (EndoBarrier): device for weight loss"
456683|NCT00469391|E2|Reported Event|Sham Control|3 subjects withdrew before the procedure. N=26 for the ITT population.
456684|NCT00469391|E1|Reported Event|GI Sleeve|N=26 for attempted device implant procedures. There were 2 subjects who withdrew from the study before the procedure and 4 unsuccessful procedure. Thus, N=21 for ITT population ( subjects with implanted devices).
456685|NCT00468312|B3|Baseline|Total|Total of all reporting groups
456686|NCT00468312|B2|Baseline|Placebo|Two sprays in each nostril once daily
456687|NCT00468312|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456688|NCT00468312|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
456689|NCT00468312|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456690|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
456691|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456692|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
456693|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456694|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
456695|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456696|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
456697|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456698|NCT00468312|O2|Outcome|Placebo|Two sprays in each nostril once daily
456699|NCT00468312|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456700|NCT00468312|E2|Reported Event|Placebo|Two sprays in each nostril once daily
456701|NCT00468312|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily in the morning. Each spray is equal to 50 mcg.
456702|NCT00468299|B3|Baseline|Total|Total of all reporting groups
456703|NCT00468299|B2|Baseline|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
456704|NCT00468299|B1|Baseline|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
456705|NCT00468299|P2|Participant Flow|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
456706|NCT00468299|P1|Participant Flow|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
456707|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women received mifeppristone 200 mg orally followed ny misoprostol 800 mcg buccally
456708|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women received a placebo followed by misoprostol 800 mcg buccally
456709|NCT00468299|O2|Outcome|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
456710|NCT00468299|O1|Outcome|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
456711|NCT00468299|E2|Reported Event|Mifepristone and Misoprostol|Women in this group received mifepristone 200 mg orally followed by misoprostol 800 mcg buccally
456712|NCT00468299|E1|Reported Event|Misoprostol and Placebo|Women in this groups received misoprostol (800 mcg buccally) plus a placebo for treatment of early pregnancy failure.
456713|NCT00468286|B3|Baseline|Total|Total of all reporting groups
456714|NCT00468286|B2|Baseline|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456715|NCT00468286|B1|Baseline|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456716|NCT00468286|P2|Participant Flow|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456717|NCT00468286|P1|Participant Flow|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456718|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456719|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456720|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456721|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456722|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456723|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456724|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456725|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456726|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456727|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456728|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456729|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456730|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456731|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456732|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456733|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456734|NCT00468286|O2|Outcome|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456735|NCT00468286|O1|Outcome|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456736|NCT00468286|E2|Reported Event|Degarelix 240/480 mg|Treatment group B: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 480 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456737|NCT00468286|E1|Reported Event|Degarelix 240/360 mg|Treatment group A: Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 360 mg SC (by injection under the skin) given after 1, 4, 7, & 10 months.
456758|NCT00469209|B1|Baseline|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456738|NCT00468208|B1|Baseline|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456739|NCT00468208|P1|Participant Flow|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456740|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456741|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456742|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456743|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456744|NCT00468208|O1|Outcome|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456745|NCT00468208|E1|Reported Event|Open-label Abatacept|"Participants received abatacept intravenously at study visits on Days 1, 15, and 29, and then once a month thereafter until common closing or early termination.~Abatacept : A participant's abatacept dose was based on body weight and remained the same throughout the study:~500 mg of abatacept for body weight less than 60 kg~750 mg of abatacept for body weight between 60 and 100 kg~1000 mg of abatacept for body weight greater than 100 kg~Abatacept was administered in a 30-minute intravenous infusion."
456746|NCT00469274|B3|Baseline|Total|Total of all reporting groups
456747|NCT00469274|B2|Baseline|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456748|NCT00469274|B1|Baseline|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456749|NCT00469274|P2|Participant Flow|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456750|NCT00469274|P1|Participant Flow|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456751|NCT00469274|O2|Outcome|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456752|NCT00469274|O1|Outcome|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456753|NCT00469274|E2|Reported Event|Antibiotic PEP|Enrolled subjects involved in a pertussis exposure who received post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456754|NCT00469274|E1|Reported Event|No PEP|Enrolled subjects involved in a pertussis exposure who received no antibiotic post-exposure prophylaxis as per standard recommendations (i.e. azithromycin 500mg x 1 day followed by 250mg Q day for on days 2-5 or trimethoprm sulfamethoxasole DS BID for 14 days)
456755|NCT00469209|B4|Baseline|Total|Total of all reporting groups
456756|NCT00469209|B3|Baseline|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456757|NCT00469209|B2|Baseline|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456819|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456759|NCT00469209|P3|Participant Flow|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456760|NCT00469209|P2|Participant Flow|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456761|NCT00469209|P1|Participant Flow|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456762|NCT00469209|O3|Outcome|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456763|NCT00469209|O2|Outcome|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456764|NCT00469209|O1|Outcome|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456765|NCT00469209|E3|Reported Event|Bortezomib 1.5 mg/m^2|Bortezomib (Level 2) 1.5 mg/m^2 IV push on Days -9, -6, and -3, Melphalan + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456766|NCT00469209|E2|Reported Event|Bortezomib 1.0 mg/m^2|Bortezomib (Level 1) 1.0 mg/m^2 IV push on Days -9, -6, and -3, Melphalan 100 mg/m^2 IV days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456767|NCT00469209|E1|Reported Event|No Bortezomib|Melphalan 100 mg/m^2 intravenous (IV) days -4,-3 + Arsenic Trioxide 0.25 mg/kg IV for 7 days + Vitamin C IV daily
456768|NCT00469092|B3|Baseline|Total|Total of all reporting groups
456769|NCT00469092|B2|Baseline|Glargine|Insulin glargine + metformin + glimepiride
456770|NCT00469092|B1|Baseline|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456771|NCT00469092|P2|Participant Flow|Glargine|Insulin glargine + metformin + glimepiride
456772|NCT00469092|P1|Participant Flow|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456773|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456774|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456775|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456776|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456777|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456778|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456779|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456780|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456781|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456782|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456783|NCT00469092|O2|Outcome|Glargine|Insulin glargine + metformin + glimepiride
456784|NCT00469092|O1|Outcome|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456785|NCT00469092|E2|Reported Event|Glargine|Insulin glargine + metformin + glimepiride
456786|NCT00469092|E1|Reported Event|BIAsp 30|Biphasic insulin aspart 30 + metformin + glimepiride
456787|NCT00469079|B4|Baseline|Total|Total of all reporting groups
456788|NCT00469079|B3|Baseline|Assigned to Camel Snus|Camel Snus - oral tobacco product
456789|NCT00469079|B2|Baseline|Assigned to Taboka|Taboka - oral tobacco product
456790|NCT00469079|B1|Baseline|Assigned to NRT|Nicotine gum or nicotine lozenge
456791|NCT00469079|P3|Participant Flow|Assigned to Camel Snus|Camel Snus - oral tobacco product
456792|NCT00469079|P2|Participant Flow|Assigned to Taboka|Taboka - oral tobacco product
456793|NCT00469079|P1|Participant Flow|Assigned to NRT|Nicotine gum or nicotine lozenge
456794|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
456795|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
456796|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
456797|NCT00469079|O3|Outcome|Camel Snus|Camel Snus - oral tobacco product
456798|NCT00469079|O2|Outcome|Taboka|Taboka - oral tobacco product
456799|NCT00469079|O1|Outcome|Medicinal Nicotine|Nicotine gum or nicotine lozenge
456800|NCT00469079|O3|Outcome|Snus|A spitless, oral tobacco pouch.
456801|NCT00469079|O2|Outcome|Taboka|A spitless, oral tobacco pouch.
456802|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or lozenge
456803|NCT00469079|O3|Outcome|Snus|Camel Snus, a spitless oral tobacco product currently marketed as a substitute for cigarettes. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
456804|NCT00469079|O2|Outcome|Taboka|Taboka, a spitless oral tobacco product that has been discontinued. The product is pasteurized rather than fermented, leading to lower tobacco specific nitrosamine levels than conventional smokeless tobacco products.
456805|NCT00469079|O1|Outcome|Medicinal Nicotine|4 mg nicotine gum or nicotine lozenge
456806|NCT00469079|E3|Reported Event|Assigned to Camel Snus|Camel Snus - oral tobacco product
456807|NCT00469079|E2|Reported Event|Assigned to Taboka|Taboka - oral tobacco product
456808|NCT00469079|E1|Reported Event|Assigned to NRT|Nicotine gum or nicotine lozenge
456809|NCT00468845|B4|Baseline|Total|Total of all reporting groups
456810|NCT00468845|B3|Baseline|Placebo|Matching placebo capsule
456811|NCT00468845|B2|Baseline|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456812|NCT00468845|B1|Baseline|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456813|NCT00468845|P3|Participant Flow|Placebo|Matching placebo capsule
456814|NCT00468845|P2|Participant Flow|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456815|NCT00468845|P1|Participant Flow|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456816|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456817|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456818|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456821|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456822|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456823|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456824|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456825|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456826|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456827|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456828|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456829|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456830|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456831|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456832|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456833|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456834|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456835|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456836|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456837|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456838|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456839|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456840|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456841|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456842|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456843|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456844|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456845|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456846|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456847|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456848|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456849|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456850|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456851|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456852|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456853|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456854|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456855|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456856|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456857|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456858|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456859|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456860|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456861|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456862|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456863|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456864|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456865|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456866|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456867|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456868|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456869|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456870|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456871|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456872|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456873|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456874|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456875|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456876|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456877|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456878|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456879|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456880|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456881|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456882|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456883|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456884|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456885|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456886|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456887|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456888|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456889|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456890|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456891|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456892|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456893|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456894|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456895|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456896|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456897|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456898|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456899|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456900|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456901|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456902|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456903|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456904|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456905|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456906|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456907|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456908|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456909|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456910|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456911|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456912|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456913|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456914|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456915|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456916|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456917|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456918|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456919|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456920|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456921|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456922|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456923|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456924|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456925|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456926|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456927|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456928|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456929|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456930|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456931|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456932|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456933|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456934|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456935|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456936|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456937|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456938|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456939|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456940|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456941|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456942|NCT00468845|O3|Outcome|Placebo|Matching placebo capsule
456943|NCT00468845|O2|Outcome|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456944|NCT00468845|O1|Outcome|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456945|NCT00468845|E3|Reported Event|Placebo|Matching placebo capsule
456946|NCT00468845|E2|Reported Event|Pregabalin 300 mg|Pregabalin 150 mg twice a day (300 mg/day total)
456947|NCT00468845|E1|Reported Event|Pregabalin 150mg|Pregabalin 75 mg twice a day (150 mg/day total)
456948|NCT00468819|B4|Baseline|Total|Total of all reporting groups
456949|NCT00468819|B3|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456950|NCT00468819|B2|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456951|NCT00468819|B1|Baseline|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456952|NCT00468819|P3|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456953|NCT00468819|P2|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456954|NCT00468819|P1|Participant Flow|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456955|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457676|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
456956|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456957|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456958|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456959|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456960|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456961|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456962|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456963|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456964|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456965|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456966|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456967|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456968|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456969|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456970|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456971|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456972|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456973|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456974|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456975|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456976|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456977|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456978|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456979|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456980|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456981|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456982|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456983|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456984|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456985|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456986|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456987|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456988|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456989|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456990|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457677|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
456991|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456992|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456993|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456994|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456995|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456996|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456997|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456998|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
456999|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457000|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457001|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457002|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457003|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457004|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457005|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457006|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457007|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457008|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457009|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457010|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457011|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457012|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457013|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457014|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457015|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457016|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457017|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457018|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457019|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457020|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457021|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457022|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457023|NCT00468819|O4|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457024|NCT00468819|O3|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457025|NCT00468819|O2|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457678|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457026|NCT00468819|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457027|NCT00468819|E4|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457028|NCT00468819|E3|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 12 to 17 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457029|NCT00468819|E2|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 7 to 11 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457030|NCT00468819|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875) - Age 2 to 6 Years|Participants received Gadobutrol 0.1 mmol/kg body weight (BW) = 0.1 mL/kg BW as single intravenous bolus injection
457031|NCT00468728|B3|Baseline|Total|Total of all reporting groups
457032|NCT00468728|B2|Baseline|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
457033|NCT00468728|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
457034|NCT00468728|P2|Participant Flow|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
457035|NCT00468728|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
457036|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
457037|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
457038|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily
457039|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily
457040|NCT00468728|O2|Outcome|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
457041|NCT00468728|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
457042|NCT00468728|E2|Reported Event|PAR-101/OPT-80|200 mg administered twice daily (q12hr)
457043|NCT00468728|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
457044|NCT00468676|B3|Baseline|Total|Total of all reporting groups
457045|NCT00468676|B2|Baseline|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457046|NCT00468676|B1|Baseline|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457047|NCT00468676|P2|Participant Flow|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457048|NCT00468676|P1|Participant Flow|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 (Patient Health Questionnaire 9) score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457049|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457050|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457051|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457066|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
462639|NCT00454532|E2|Reported Event|Level 2|20g/day
457052|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457053|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457054|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457055|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psycho-education, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 (Patient Health Questionnaire 9) scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457056|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457057|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457058|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457059|NCT00468676|O2|Outcome|Care Management Intervention|Case management intervention: patients assigned to care management received intervention visits with a medical nurse supervised weekly by both a psychiatrist and primary care doctor. Nurses provided psychoeducation, motivational interviewing, behavioral activation and problem solving and carefully tracked medications, side effects, PHQ-9 scores and blood pressure and lab results. Using a registry the medical supervisors recommended changes in medications that the nurse communicated to the patient's individual primary care doctor (who wrote all prescriptions). Nurses also worked with the patient to set self care goals regarding health behaviors such as increasing exercise or improving diet
457060|NCT00468676|O1|Outcome|Usual Care|Patients in usual care arm were advised to consult with their primary care physician to receive care for depression and for diabetes, coronary artery disease or both. With the patient's permission their primary care physician was notified about their PHQ-9 score of 10 or greater and poor medical disease control. In addition primary care doctors received laboratory results at baseline, 6 and 12 months regarding HbA1c and at baseline and 12 months on fasting LDL
457061|NCT00468676|O1|Outcome|Effect Size of Invervention Group to Standard Care|This was an intent to treat analysis calculating the intervention effect size of the 12 month SCL-20, HbA1c, LDL and systolic blood pressure outcomes combined
457062|NCT00468676|E2|Reported Event|Care Management Intervention|"Care management intervention~Nurse-led case management: The case management intervention will entail approximately 10 visits with a trained nurse at the clinic or by telephone. Participants in this group will receive educational materials about how to manage diabetes and/or heart disease and stress or depression. Nurses will also provide guidance and support in managing medications, phone calls to check participants' progress, and assistance in setting personal goals and in managing physical health problems and symptoms of depression or stress."
457063|NCT00468676|E1|Reported Event|Usual Care|"Treatment as usual~Treatment as usual: Participants will attend 10 study visits and receive 4 follow-up phone calls over 24 months. During this time, participants will receive usual care."
457064|NCT00468650|B1|Baseline|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457065|NCT00468650|P1|Participant Flow|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457302|NCT00468104|B1|Baseline|Alteplase; Placebo|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally; 100 cc of normal saline instilled intrapleurally
457067|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457068|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457069|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457070|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457071|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457072|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457073|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457074|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457075|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457076|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457077|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457078|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457079|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457080|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457081|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457082|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457083|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457084|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457085|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457679|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457086|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457087|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457088|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457089|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457090|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457091|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457092|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457093|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457094|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457095|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457096|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457097|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457098|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457099|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457100|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457101|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457102|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457103|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457104|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and, thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457680|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457105|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457106|NCT00468650|O1|Outcome|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457107|NCT00468650|E1|Reported Event|Open Label Sildenafil Citrate|Eligible patients fulfilling all inclusion/exclusion criteria will be assigned at Visit 2/Week 0 (Baseline) to receive sildenafil citrate 50 mg as needed (PRN) during the first two weeks, and,thereafter, at Visit 3/Week 2, all enrolled subjects will be up titrated to sildenafil citrate 100 mg PRN for the following four weeks.
457108|NCT00468585|B5|Baseline|Total|Total of all reporting groups
457109|NCT00468585|B4|Baseline|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
457110|NCT00468585|B3|Baseline|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
457111|NCT00468585|B2|Baseline|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
457112|NCT00468585|B1|Baseline|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
457113|NCT00468585|P4|Participant Flow|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
457114|NCT00468585|P3|Participant Flow|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
457115|NCT00468585|P2|Participant Flow|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
457116|NCT00468585|P1|Participant Flow|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
457117|NCT00468585|O4|Outcome|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
457118|NCT00468585|O3|Outcome|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
457119|NCT00468585|O2|Outcome|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
457120|NCT00468585|O1|Outcome|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
457121|NCT00468585|E4|Reported Event|Group 3|Capecitabine - AM 2000 mg; PM 2500mg; total daily 4500 mg
457122|NCT00468585|E3|Reported Event|Group 2|Capecitabine - AM 2000 mg; PM 2000 mg; total daily 4000 mg
457123|NCT00468585|E2|Reported Event|Group 1|Capecitabine - AM 1500 mg; PM 2000 mg; total daily 3500 mg
457124|NCT00468585|E1|Reported Event|Group 0|Capecitabine - AM 1500mg; PM 1500 mg; total daily 3000 mg
457125|NCT00468559|B3|Baseline|Total|Total of all reporting groups
457126|NCT00468559|B2|Baseline|Double Blind Placebo|
457127|NCT00468559|B1|Baseline|Double Blind Esomeprazole|
457128|NCT00468559|P3|Participant Flow|Double Blind Placebo|
457129|NCT00468559|P2|Participant Flow|Double Blind Esomeprazole|
457130|NCT00468559|P1|Participant Flow|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight). Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
457131|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
457132|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
457133|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
457134|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
457135|NCT00468559|O1|Outcome|Open Label Esomeprazole|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight)
457136|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457137|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457138|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457139|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457140|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457141|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457142|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457143|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457144|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457145|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457146|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457147|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457148|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457149|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457150|NCT00468559|O2|Outcome|Double Blind Placebo|Participants in this group received placebo during the double-blind treatment withdrawal phase.
457151|NCT00468559|O1|Outcome|Double Blind Esomeprazole|In the double-blind treatment-withdrawal phase of the study, participants in this group received double-blind esomeprazole at the same dose they received in the preceeding open-label phase of the study.
457152|NCT00468559|E3|Reported Event|Double Blind Placebo|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
457153|NCT00468559|E2|Reported Event|Double Blind Esomeprazole|Eligible participants from the Open Label phase were randomized to the the double blind withdrawal phase.
457154|NCT00468559|E1|Reported Event|Open-label Phase|Open-label daily esomeprazole (2.5mg, 5mg or 10mg daily during open-label phase of the study, according to baseline weight).
457155|NCT00468546|B3|Baseline|Total|Total of all reporting groups
457156|NCT00468546|B2|Baseline|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457157|NCT00468546|B1|Baseline|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457158|NCT00468546|P2|Participant Flow|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457159|NCT00468546|P1|Participant Flow|Placebo Plus Methotrexate|Eligible participants were administered the placebo by intravenous infusion on Days 1 and 15 along with methotrexate (MTX) 10-25 milligrams (mg) per os (p.o.) or parenterally once a week up to Week 24 and were followed up to Week 104.
457160|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457161|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457162|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457163|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457164|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457165|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457166|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457167|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457168|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457169|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457170|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457171|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457172|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457173|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457174|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457175|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457176|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457177|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457178|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457179|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457180|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457181|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457182|NCT00468546|O2|Outcome|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457183|NCT00468546|O1|Outcome|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457184|NCT00468546|E2|Reported Event|Rituximab Plus Methotrexate|Eligible Participants were administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and were followed up to Week 104.
457185|NCT00468546|E1|Reported Event|Placebo Plus Methotrexate|Eligible participants were administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to 24 weeks and were followed up to Week 104.
457186|NCT00468481|B3|Baseline|Total|Total of all reporting groups
457187|NCT00468481|B2|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457188|NCT00468481|B1|Baseline|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457189|NCT00468481|P2|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457190|NCT00468481|P1|Participant Flow|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457191|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457192|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457193|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457194|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457195|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457196|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457197|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457198|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457199|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457200|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457201|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457202|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457203|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457204|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457205|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457372|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457206|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457207|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457208|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457209|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457210|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457211|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457212|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457213|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457214|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457215|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457216|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457217|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457218|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457219|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457220|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457221|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457222|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457223|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457224|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457225|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457226|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457227|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457228|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457229|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457230|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457231|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457661|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
462640|NCT00454532|E1|Reported Event|Level 1|10g/day
457232|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457233|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457234|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457235|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457236|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457237|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457238|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457239|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457240|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457241|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457242|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457243|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457244|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457245|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457246|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457247|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457248|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457249|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457250|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457251|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457252|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457253|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457254|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457255|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457256|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457257|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457662|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457663|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457258|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457259|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457260|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457261|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457262|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457263|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457264|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457265|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457266|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457267|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457268|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457269|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457270|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457271|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457272|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457273|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457274|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457275|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457276|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457277|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457278|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457279|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457280|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457281|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457282|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457283|NCT00468481|O2|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457664|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
462641|NCT00454363|B3|Baseline|Total|Total of all reporting groups
457284|NCT00468481|O1|Outcome|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457285|NCT00468481|E2|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)|1 tablet 0.020 mg EE/3.0 mg DRSP [YAZ] given orally/daily for 24 days followed by 1 placebo tablet given orally/daily for 4 days over a time period of 24 weeks
457286|NCT00468481|E1|Reported Event|Drospirenone (DRSP)/Ethinylestradiol (EE)/Metafolin (MTHF)|1 tablet 0.020 mg EE/3.0 mg DRSP/0.451 mg L-5-MTHF as calcium salt given orally/daily for 24 days followed by 1 tablet 0.451 mg L-5-MTHF as calcium salt given orally/daily for 4 days over a time period of 24 weeks
457287|NCT00468143|B1|Baseline|All Participants|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
457288|NCT00468143|P2|Participant Flow|Immediate Release First|This group received the immediate release medication during the first three weeks of treatment and then received the extended release medication during the last 3 weeks of treatment.
457289|NCT00468143|P1|Participant Flow|Extended Release First|This group received the extended release medication during the first three weeks of treatment and then received the immediate release medication during the last 3 weeks of treatment.
457290|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457291|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457292|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457293|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457294|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457295|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457296|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457297|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457298|NCT00468143|O2|Outcome|Adderall XR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (15 mg qAM for Adderall XR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457299|NCT00468143|O1|Outcome|Adderall IR (Methamphetamine Salts)|All participants were initiated at a total daily dose of 15 mg/day (5 mg TID for Adderall IR (Methamphetamine Salts)). At visits 3 and 4, the total daily dose of MAS was increased by 15 mg/day until an optimal dose or the maximum total daily dose of 45 mg/day was reached. An optimal dose was determined by clinical efficacy (a ≥ 30% reduction in the baseline total ADHD Rating Scale [ADHD-RS] scores) and tolerability.
457300|NCT00468143|E2|Reported Event|Immediate Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
457301|NCT00468143|E1|Reported Event|Extended Release|This was a randomized, crossover study in which participants received 3 weeks of treatment with MAS IR (15, 30, or 45 mg TID) and 3 weeks of treatment with MAS XR (15, 30, or 45 mg qAM). The order of the treatments (TID-qAM or qAM-TID) was counterbalanced across participants, with a washout period of ≥ 7 days between epochs.
457665|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457303|NCT00468104|P2|Participant Flow|Placebo Then Alteplase|Placebo in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Alteplase)
457304|NCT00468104|P1|Participant Flow|Alteplase Then Placebo|25 mg of Alteplase in 100 cc of normal saline was instilled intrapleurally daily for three days. Chest CT scans were performed on the fourth day . If less than a 50% reduction in the pleural effusion was determined, the patient was given the option to go to surgery or to the second intervention of the trial (with Placebo)
457305|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
457306|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
457307|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
457308|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
457309|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
457310|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
457311|NCT00468104|O2|Outcome|Placebo|100 cc of normal saline instilled intrapleurally
457312|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline instilled intrapleurally
457313|NCT00468104|O2|Outcome|Placebo|Placebo in 100 cc of normal saline given daily intrapleurally for 3 days either in the first or second arm
457314|NCT00468104|O1|Outcome|Alteplase|25mg of Alteplase in 100 cc of normal saline given intrapleurally daily for 3 days either in the first or second arm
457315|NCT00468104|E3|Reported Event|Received Both Alteplase and Placebo|These patients were crossed over and received both Alteplase and Placebo
457316|NCT00468104|E2|Reported Event|Received Placebo Only|These patients received Placebo only and were not crossed over
457317|NCT00468104|E1|Reported Event|Received Alteplase Only|These patients received only Alteplase and were not crossed over
457318|NCT00468052|B3|Baseline|Total|Total of all reporting groups
457319|NCT00468052|B2|Baseline|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457320|NCT00468052|B1|Baseline|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457321|NCT00468052|P2|Participant Flow|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457322|NCT00468052|P1|Participant Flow|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457323|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
457324|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
457325|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
457326|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
457327|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457328|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457329|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457330|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457331|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457332|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457333|NCT00468052|O2|Outcome|Dexmedetomidine|"dexmedetomidine 2ug.kg-1 over 10 min followed by 0.7ug.kg-1.h-1~dexmedetomidine: 2 micrograms/kilogram as a bolus then 0.7 micrograms/kilogram infusion"
457334|NCT00468052|O1|Outcome|Fentanyl|"fentanyl bolus 1ug.kg-1~fentanyl: 1 microgram/kilogram as a bolus"
457335|NCT00468052|O2|Outcome|Dexmedetomidine|61 subjects Group D received IV dexmedetomidine 2mcg/kg over 10 minutes followed by an infusion of 0.7mcg.kg/hr
457336|NCT00468052|O1|Outcome|Fentanyl (F) Group|"61 subjects in group F received IV (1mcg/kg)as a bolus as soon as IV access was established.~0"
457337|NCT00468052|E2|Reported Event|Dexmedetomidine|1 subjects Group D experienced an adverse event.
457338|NCT00468052|E1|Reported Event|Fentanyl (F) Group|"No subjects in group F experienced an adverse event.~0"
457339|NCT00467961|B1|Baseline|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
457340|NCT00467961|P1|Participant Flow|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
457371|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457341|NCT00467961|O1|Outcome|Selective T Cell Depletion Transplant Recipients|"Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach (Kiadis Pharma). Older subjects will receive a lower dose of irradiation to reduce the regimen intensity.~To determine appropriate level of post transplant immunosuppression."
457342|NCT00467961|E1|Reported Event|Selective T Cell Depletion Transplant Recipients|Subjects will receive a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation, followed by an infusion of a stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a lymphocyte product that has been selectively depleted using the photodepletion approach. Older subjects will receive a lower dose of irradiation to reduce the regimen intensity. To determine appropriate level of post transplant immunosuppression, a three sequential de-escalation stage design for timing of cyclosporine will be utilized.
457343|NCT00467896|B1|Baseline|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
457344|NCT00467896|P1|Participant Flow|Iloprost|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) and Power Disc-15 (PD-15).
457345|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6) in Period I and Power Disc-15 (PD-15)in Period II.
457346|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457347|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457348|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457349|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457350|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457351|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457352|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457353|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457354|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457355|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457356|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457357|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457358|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457359|NCT00467896|O1|Outcome|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457360|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457361|NCT00467896|O1|Outcome|Iloprost PD-6|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-6 (PD-6).
457362|NCT00467896|E1|Reported Event|Iloprost PD-15|iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery System (AAD) using Power Disc-15 (PD-15).
457363|NCT00467857|B3|Baseline|Total|Total of all reporting groups
457364|NCT00467857|B2|Baseline|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457365|NCT00467857|B1|Baseline|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457366|NCT00467857|P2|Participant Flow|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457367|NCT00467857|P1|Participant Flow|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457368|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457369|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457370|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457666|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457373|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457374|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457375|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457376|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457377|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457378|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457379|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457380|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457381|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457382|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457383|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457384|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457385|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457386|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457387|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457388|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457389|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457390|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457391|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457392|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457393|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457394|NCT00467857|O2|Outcome|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457395|NCT00467857|O1|Outcome|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457396|NCT00467857|E2|Reported Event|Standard Surgical Preparation Solutions|Prior to incision, standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w.
457667|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457397|NCT00467857|E1|Reported Event|InteguSeal* and Standard Surgical Preparation Solutions|Prior to incision, surgical sites were prepared using InteguSeal* following standard surgical preparation with povidone iodine or 0.7% available iodine in isopropyl alcohol 74% w/w. InteguSeal* is a film-forming cyanoacrylate-based microbial skin sealant developed to decrease wound contamination by endogenous skin flora.
457398|NCT00467844|B4|Baseline|Total|Total of all reporting groups
457399|NCT00467844|B3|Baseline|3 mg of Placebo|Placebo
457400|NCT00467844|B2|Baseline|GTx-024|3 mg
457401|NCT00467844|B1|Baseline|GTx -024|1 mg
457402|NCT00467844|P3|Participant Flow|3 mg of Placebo|Placebo
457403|NCT00467844|P2|Participant Flow|GTx-024|3 mg
457404|NCT00467844|P1|Participant Flow|GTx -024|1 mg
457405|NCT00467844|O3|Outcome|3 mg of Placebo|Placebo
457406|NCT00467844|O2|Outcome|GTx-024|3 mg
457407|NCT00467844|O1|Outcome|GTx -024|1 mg
457408|NCT00467844|O3|Outcome|Placebo|Placebo
457409|NCT00467844|O2|Outcome|GTx-024 3 mg|
457410|NCT00467844|O1|Outcome|GTx-024 1 mg|
457411|NCT00467844|E3|Reported Event|3 mg of Placebo|Placebo
457412|NCT00467844|E2|Reported Event|GTx-024|3 mg
457413|NCT00467844|E1|Reported Event|GTx -024|1 mg
457414|NCT00467831|B1|Baseline|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
457415|NCT00467831|P1|Participant Flow|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
457416|NCT00467831|O1|Outcome|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
457417|NCT00467831|E1|Reported Event|Multi-Drug Regimen|"Losartan, 25 mg by mouth every night at bedtime; Zileuton, 1200 mg by mouth twice daily; N-acetylcysteine, 600 mg by mouth three times daily; Pravastatin, 20 mg by mouth every night at bedtime; Erythromycin, 333 mg by mouth three times daily.~Erythromycin : Erythromycin tablet, 333 mg by mouth three times daily.~Losartan : Losartan potassium tablet, 25 mg by mouth every night at bedtime.~Zileuton : Zileuton tablet, 1200 mg by mouth twice daily.~N-Acetylcysteine : N-acetylcysteine solution, 600 mg by mouth three times daily.~Pravastatin : Pravastatin sodium tablet, 20 mg by mouth every night at bedtime."
457418|NCT00467779|B16|Baseline|Total|Total of all reporting groups
457419|NCT00467779|B15|Baseline|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457420|NCT00467779|B14|Baseline|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457421|NCT00467779|B13|Baseline|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457422|NCT00467779|B12|Baseline|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457423|NCT00467779|B11|Baseline|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457424|NCT00467779|B10|Baseline|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457425|NCT00467779|B9|Baseline|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457426|NCT00467779|B8|Baseline|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457427|NCT00467779|B7|Baseline|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457428|NCT00467779|B6|Baseline|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457429|NCT00467779|B5|Baseline|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457430|NCT00467779|B4|Baseline|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457431|NCT00467779|B3|Baseline|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457432|NCT00467779|B2|Baseline|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457433|NCT00467779|B1|Baseline|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457434|NCT00467779|P15|Participant Flow|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. In Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457435|NCT00467779|P14|Participant Flow|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457436|NCT00467779|P13|Participant Flow|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457437|NCT00467779|P12|Participant Flow|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457438|NCT00467779|P11|Participant Flow|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457439|NCT00467779|P10|Participant Flow|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457440|NCT00467779|P9|Participant Flow|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457441|NCT00467779|P8|Participant Flow|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457442|NCT00467779|P7|Participant Flow|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457443|NCT00467779|P6|Participant Flow|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457444|NCT00467779|P5|Participant Flow|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457445|NCT00467779|P4|Participant Flow|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457668|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457669|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457446|NCT00467779|P3|Participant Flow|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457447|NCT00467779|P2|Participant Flow|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457448|NCT00467779|P1|Participant Flow|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 milligrams per kilograms (mg/kg) via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457449|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457450|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457451|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457452|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457453|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457454|NCT00467779|O1|Outcome|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period.Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457455|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457456|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457457|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457458|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457459|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457460|NCT00467779|O1|Outcome|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457670|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
464081|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
457461|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457462|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457463|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457464|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457465|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457466|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457467|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457468|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457469|NCT00467779|O1|Outcome|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457470|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457471|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457472|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457473|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457474|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457475|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457476|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457477|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457478|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457479|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457480|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457671|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457481|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457482|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457483|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457484|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457485|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457486|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457487|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457488|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457489|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457490|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457491|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457492|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457493|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457494|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457495|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457496|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457497|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457498|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457499|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457500|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457501|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457502|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457503|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457504|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457505|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457506|NCT00467779|O4|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457507|NCT00467779|O3|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457508|NCT00467779|O2|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457509|NCT00467779|O1|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457510|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457511|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457512|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457513|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457514|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457515|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457516|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457517|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457518|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457519|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457520|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
458373|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
457521|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457522|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457523|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457524|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457525|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457526|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457527|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457528|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457529|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457530|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457531|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457532|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457533|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457534|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457535|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457536|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457537|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457538|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457539|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457540|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457672|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457541|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457542|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457543|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457544|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457545|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457546|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457547|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457548|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457549|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457550|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457551|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457552|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457553|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457554|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457555|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457556|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457557|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457558|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457559|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457560|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
466455|NCT00443053|B2|Baseline|Placebo|Matching placebo
457561|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457562|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457563|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457564|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457565|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457566|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457567|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457568|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457569|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457570|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457571|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457572|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457573|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457574|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457575|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457576|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457577|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457578|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457579|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457580|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457673|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
468729|NCT00437983|B3|Baseline|Total|Total of all reporting groups
457581|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457582|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457583|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457584|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457585|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457586|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457587|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457588|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457589|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457590|NCT00467779|O1|Outcome|Stage 1A - All Cohorts (14/14)|Participants received cobimetinib via solution or capsule, once daily for Days 1-14 of each 28-day cycle and were on a 14-days-on and 14-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457591|NCT00467779|O1|Outcome|Stage 1 All Cohorts (21/7)|Participants received cobimetinib via solution or capsule, once daily for Days 1-21 of each 28-day cycle and were on 21-days-on and 7-days-off schedule. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457592|NCT00467779|O12|Outcome|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457593|NCT00467779|O11|Outcome|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457594|NCT00467779|O10|Outcome|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457595|NCT00467779|O9|Outcome|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457596|NCT00467779|O8|Outcome|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457597|NCT00467779|O7|Outcome|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457598|NCT00467779|O6|Outcome|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457599|NCT00467779|O5|Outcome|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457600|NCT00467779|O4|Outcome|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
468730|NCT00437983|B2|Baseline|Placebo|Cellulose tainted with fishy odor
457601|NCT00467779|O3|Outcome|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457602|NCT00467779|O2|Outcome|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457603|NCT00467779|O1|Outcome|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib (GDC-0973/XL518) 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle (21 days on drug followed by 7 days off treatment [21/7 schedule]). Treatment was continued until progressive disease (PD) or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457604|NCT00467779|E15|Reported Event|Stage 3 Cohort 40 - Cobimetinib+Midazolam+Dextromethorphan|Participants received a single dose of midazolam (2 mg of midazolam syrup) and dextromethorphan (30 mg tablet) on Cycle 1 Day 1, in the absence of cobimetinib. After a 2-day washout period, participants received 21 consecutive daily doses of cobimetinib (60-mg) followed by a 7-day washout period. Participants received another single dose of midazolam and dextromethorphan on Cycle 1 Day 15, in the presence of steady-state cobimetinib concentrations. in Cycle 2 and beyond received cobimetinib alone, administered as a 60-mg daily dose for 21 consecutive days in 28-day cycles.
457605|NCT00467779|E14|Reported Event|Stage 2A Cohort 30 - Cobimetinib 100 mg (Expansion) (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457606|NCT00467779|E13|Reported Event|Stage 1A Cohort 04A - Cobimetinib 125 mg (14/14)|Participants received cobimetinib 125 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457607|NCT00467779|E12|Reported Event|Stage 1A Cohort 03A - Cobimetinib 100 mg (14/14)|Participants received cobimetinib 100 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457608|NCT00467779|E11|Reported Event|Stage 1A Cohort 02A - Cobimetinib 80 mg (14/14)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457609|NCT00467779|E10|Reported Event|Stage 1A Cohort 01A - Cobimetinib 60 mg (14/14)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-14 of each 28-day cycle (14 days on drug followed by 14 days off treatment [14/14 schedule]). Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457610|NCT00467779|E9|Reported Event|Stage 2 Cohort 20 – Cobimetinib 60 mg (Expansion) (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457611|NCT00467779|E8|Reported Event|Stage 1 Cohort 08 - Cobimetinib 80 mg (21/7)|Participants received cobimetinib 80 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457612|NCT00467779|E7|Reported Event|Stage 1 Cohort 07 – Cobimetinib 60 mg (21/7)|Participants received cobimetinib 60 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457613|NCT00467779|E6|Reported Event|Stage 1 Cohort 06 - Cobimetinib 40 mg (21/7)|Participants received cobimetinib 40 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457614|NCT00467779|E5|Reported Event|Stage 1 Cohort 05 - Cobimetinib 20 mg (21/7)|Participants received cobimetinib 20 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457615|NCT00467779|E4|Reported Event|Stage 1 Cohort 04 - Cobimetinib 10 mg (21/7)|Participants received cobimetinib 10 mg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457616|NCT00467779|E3|Reported Event|Stage 1 Cohort 03 – Cobimetinib 0.20 mg/kg (21/7)|Participants received cobimetinib 0.20 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457617|NCT00467779|E2|Reported Event|Stage 1 Cohort 02 – Cobimetinib 0.10 mg/kg (21/7)|Participants received cobimetinib 0.10 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457618|NCT00467779|E1|Reported Event|Stage 1 Cohort 01 – Cobimetinib 0.05 mg/kg (21/7)|Participants received cobimetinib 0.05 mg/kg via solution or capsule, once daily for Days 1-21 of each 28-day cycle. Treatment was continued until PD or unacceptable toxicity for up to 1 year at the discretion of investigator and beyond 1 year with the agreement of the sponsor.
457619|NCT00467753|B3|Baseline|Total|Total of all reporting groups
457620|NCT00467753|B2|Baseline|Sugar Pill|Placebo : Dosage similar to active drug
457674|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457675|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457621|NCT00467753|B1|Baseline|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
457622|NCT00467753|P2|Participant Flow|Sugar Pill|Placebo : Dosage similar to active drug
457623|NCT00467753|P1|Participant Flow|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
457624|NCT00467753|O2|Outcome|Sugar Pill|Placebo : Dosage similar to active drug
457625|NCT00467753|O1|Outcome|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
457626|NCT00467753|E2|Reported Event|Sugar Pill|Placebo : Dosage similar to active drug
457627|NCT00467753|E1|Reported Event|Oxcarbazepine|"Oxcarbazepine is the active drug to be given to subjects in the experimental arm~Oxcarbazepine : Oxcarbazepine is available in a 300mg/5ml solution. Dosage will start at 150 mg (2.5ml) at night for 3 days and will be increased to 150 mg in the am and pm. For children who are able to tolerate the 150 mg BID dose, the oxcarbazepine will be increased to 300 mg at night and 150 mg in the AM for 3 days and 300 mg BID for the next week. The children will remain on this dose until week 3, at which time if they are tolerating the medication and do not have a CGI of 1 (very much improved) they will be increased to 600 mg twice a day in a method similar to the above increases. After week 4, the child will remain on the same stable dose."
457628|NCT00467740|B6|Baseline|Total|Total of all reporting groups
457629|NCT00467740|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457630|NCT00467740|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457631|NCT00467740|B3|Baseline|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457632|NCT00467740|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457633|NCT00467740|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457634|NCT00467740|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457635|NCT00467740|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457636|NCT00467740|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457637|NCT00467740|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457638|NCT00467740|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457639|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457640|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457641|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457642|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457643|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457644|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457645|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457646|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457647|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457648|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457649|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457650|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457651|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457652|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457653|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457654|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457655|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457656|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457657|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457658|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457659|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457660|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457681|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457682|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457683|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457684|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457685|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457686|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457687|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457688|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457689|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457690|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457691|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457692|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457693|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457694|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457695|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457696|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457697|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457698|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457699|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457700|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457701|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457702|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457703|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457704|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457705|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457706|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457707|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457708|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457709|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457710|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457711|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457712|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457713|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457714|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457715|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457716|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457717|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457718|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457719|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457720|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457721|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457722|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457723|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457724|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457725|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457726|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457727|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457728|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457729|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457730|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457731|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457732|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457733|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457734|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457735|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457736|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457737|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457738|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457739|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457740|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457741|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457742|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457743|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457744|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457745|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457746|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457747|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457748|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457749|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457750|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457751|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457752|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457753|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457754|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457755|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457756|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457757|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457758|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457759|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457760|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457761|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457762|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457763|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457764|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457765|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457766|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457767|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457768|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457769|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457770|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457771|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457772|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457773|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457774|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457775|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457776|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457777|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457778|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457779|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457780|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457781|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457782|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457783|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457784|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457785|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457786|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457787|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457788|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457789|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457790|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457791|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457792|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457793|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457794|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457795|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457796|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457797|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457798|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457799|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457800|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457801|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457802|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457803|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457804|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457805|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457806|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457807|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457808|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457809|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457810|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457811|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457812|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457813|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457814|NCT00467740|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457815|NCT00467740|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457816|NCT00467740|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457817|NCT00467740|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457818|NCT00467740|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457819|NCT00467740|E5|Reported Event|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
457820|NCT00467740|E4|Reported Event|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
457821|NCT00467740|E3|Reported Event|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
457822|NCT00467740|E2|Reported Event|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
457823|NCT00467740|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
457824|NCT00467649|B3|Baseline|Total|Total of all reporting groups
457825|NCT00467649|B2|Baseline|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457826|NCT00467649|B1|Baseline|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457827|NCT00467649|P6|Participant Flow|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
457828|NCT00467649|P5|Participant Flow|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457829|NCT00467649|P4|Participant Flow|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
457830|NCT00467649|P3|Participant Flow|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457831|NCT00467649|P2|Participant Flow|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457832|NCT00467649|P1|Participant Flow|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457833|NCT00467649|O6|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
457834|NCT00467649|O5|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457835|NCT00467649|O4|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
457836|NCT00467649|O3|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457837|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457838|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457839|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
457840|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457841|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
457842|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457843|NCT00467649|O4|Outcome|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
457844|NCT00467649|O3|Outcome|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457845|NCT00467649|O2|Outcome|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
457846|NCT00467649|O1|Outcome|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457847|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457848|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457849|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457850|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457851|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457852|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457853|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457854|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457855|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457856|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457857|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457858|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457859|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457860|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457861|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457862|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457863|NCT00467649|O2|Outcome|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457864|NCT00467649|O1|Outcome|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457865|NCT00467649|E6|Reported Event|Group F (Phase 2 RA Insulin + SYMLIN)|Patients from Group B, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated SYMLIN during Phase 2
457866|NCT00467649|E5|Reported Event|Group E (Phase 2 RA Insulin)|Patients from Group B, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457867|NCT00467649|E4|Reported Event|Group D (Phase 2 SYMLIN+RA)|Patients from Group A, who did not achieve HbA1c goal at Week 24, continued Phase 1 treatment and initiated RA insulin during Phase 2
457868|NCT00467649|E3|Reported Event|Group C (Phase 2 SYMLIN)|Patients from Group A, who achieved HbA1c goal at Week 24, continued Phase 1 treatment during Phase 2
457869|NCT00467649|E2|Reported Event|Group B (Phase 1 RA Insulin)|Rapid acting insulin (RA Insulin: variable dosing, titrated to optimize postprandial glucose control) was initiated at Week 4. Basal insulin was titrated throughout the study
457870|NCT00467649|E1|Reported Event|Group A (Phase 1 SYMLIN)|SYMLIN treatment (120 mcg prior to major meals) was initiated on Day 1. Basal insulin was titrated throughout the study
457871|NCT00467610|B1|Baseline|Group 1|Panhematin treatment arm
457872|NCT00467610|P1|Participant Flow|Group 1|Panhematin treatment arm
457873|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
457874|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
457875|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
457876|NCT00467610|O1|Outcome|Group 1|Panhematin treatment arm
457877|NCT00467610|E1|Reported Event|Group 1|Panhematin treatment arm
457878|NCT00467597|B5|Baseline|Total|Total of all reporting groups
457879|NCT00467597|B4|Baseline|Controls - No PD|Controls with no Parkinson's disease
457880|NCT00467597|B3|Baseline|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
457881|NCT00467597|B2|Baseline|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
457882|NCT00467597|B1|Baseline|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
457883|NCT00467597|P2|Participant Flow|Controls|Non-Parkinson's Disease Controls (no intervention).
457884|NCT00467597|P1|Participant Flow|Parkinson's Disease|Parkinson's disease with and without Levodopa-Induced Dyskinesia (no intervention).
457885|NCT00467597|O4|Outcome|Controls - No PD|Controls with no Parkinson's disease
457886|NCT00467597|O3|Outcome|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
457887|NCT00467597|O2|Outcome|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
457888|NCT00467597|O1|Outcome|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
457889|NCT00467597|E4|Reported Event|Controls - No PD|Controls with no Parkinson's disease
457890|NCT00467597|E3|Reported Event|PD - Mod LID|Parkinson's disease with moderate to severe levodopa-induced dyskinesia (mAIMS > 8)
457891|NCT00467597|E2|Reported Event|PD - Mild LID|Parkinson's disease with mild to moderate levodopa-induced dyskinesia (mAIMS <= 7)
457892|NCT00467597|E1|Reported Event|PD - No LID|Parkinson's disease without levodopa-induced dyskinesia
457893|NCT00467584|B4|Baseline|Total|Total of all reporting groups
457894|NCT00467584|B3|Baseline|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
457895|NCT00467584|B2|Baseline|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
457896|NCT00467584|B1|Baseline|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
457897|NCT00467584|P3|Participant Flow|Placebo|"Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks~Placebo: Placebo tablets matching the active aspirin tablets in appearance, taken as two tablets, twice per day for 8 weeks"
457898|NCT00467584|P2|Participant Flow|Low Dose Aspirin|"Low Dose Aspirin; 162 milligrams of aspirin per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks~Low Dose Aspirin (162 mg/day): 162 milligrams per day (the equivalent of 2 baby aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
457899|NCT00467584|P1|Participant Flow|High Dose Aspirin|"High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks~High Dose Aspirin (1300 mg/day): 1300 milligrams per day (the equivalent of 4 regular aspirin tablets) taken by mouth as two tablets, twice a day in the morning and at noon for 8 weeks"
457900|NCT00467584|O3|Outcome|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
457901|NCT00467584|O2|Outcome|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
457902|NCT00467584|O1|Outcome|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
457903|NCT00467584|E3|Reported Event|Placebo|Placebo tablets, matching the active aspirin tablets in appearance, taken by mouth twice per day for 8 weeks
457904|NCT00467584|E2|Reported Event|Low Dose Aspirin|Low Dose Aspirin; 162 milligrams of aspirin per day taken by mouth as two tablets, twice per day for 8 weeks
457905|NCT00467584|E1|Reported Event|High Dose Aspirin|High Dose Aspirin; 1300 milligrams of aspirin per day, taken by mouth as two tablets, twice per day for 8 weeks
457906|NCT00467558|B3|Baseline|Total|Total of all reporting groups
457907|NCT00467558|B2|Baseline|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
457908|NCT00467558|B1|Baseline|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
457909|NCT00467558|P2|Participant Flow|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
457910|NCT00467558|P1|Participant Flow|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
457911|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
457912|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
457913|NCT00467558|O2|Outcome|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
457914|NCT00467558|O1|Outcome|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
457915|NCT00467558|E2|Reported Event|Placebo|Placebo pills (1-3 pills daily) depending upon dose prescribed by study physician
457916|NCT00467558|E1|Reported Event|Naltrexone|Naltrexone 50mg-150mg by mouth per day.
457917|NCT00467519|B3|Baseline|Total|Total of all reporting groups
457918|NCT00467519|B2|Baseline|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457919|NCT00467519|B1|Baseline|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457920|NCT00467519|P2|Participant Flow|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457921|NCT00467519|P1|Participant Flow|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457922|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457923|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457924|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457925|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457926|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457927|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457928|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457929|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
458428|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
457930|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457931|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457932|NCT00467519|O2|Outcome|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457933|NCT00467519|O1|Outcome|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457934|NCT00467519|E2|Reported Event|DTaP Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of diphtheria, tetanus and acellular pertussis vaccine (DTaP).
457935|NCT00467519|E1|Reported Event|Tdap Vaccine Group|Participants 4 to 6 years of age who had previously received 4 doses of Pentacel or DAPTACEL received a booster dose of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine adsorbed (Tdap).
457936|NCT00467389|B1|Baseline|All Participants|All recruited subjects
457937|NCT00467389|P2|Participant Flow|Donepezil Treatment First|Participants initially treated with oral donepezil, and later treated with oral placebo
457938|NCT00467389|P1|Participant Flow|Placebo Treatment First|Participants initially treated with oral placebo, and later treated with oral donepezil
457939|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
457940|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
457941|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
457942|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
457943|NCT00467389|O2|Outcome|Donepezil Treatment Period|Active Treatment
457944|NCT00467389|O1|Outcome|Placebo Treatment Period|Inactive Comparator
457945|NCT00467389|E2|Reported Event|Donepezil Treatment Period|Active Treatment
457946|NCT00467389|E1|Reported Event|Placebo Treatment Period|Inactive Comparator.
457947|NCT00467363|B3|Baseline|Total|Total of all reporting groups
457948|NCT00467363|B2|Baseline|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457949|NCT00467363|B1|Baseline|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457950|NCT00467363|P2|Participant Flow|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457951|NCT00467363|P1|Participant Flow|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457952|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457953|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457954|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457955|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457956|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457957|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457958|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457959|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457960|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457961|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457962|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457963|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457964|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457965|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457966|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457967|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457968|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457969|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457970|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457971|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457972|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457973|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457974|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457975|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457976|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457977|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457978|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457979|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457980|NCT00467363|O2|Outcome|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457981|NCT00467363|O1|Outcome|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457982|NCT00467363|E2|Reported Event|Placebo|"400micrograms of folic acid.~Folic acid: 400micrograms of folic acid."
457983|NCT00467363|E1|Reported Event|Aspirin|"81mg of low-dose aspirin plus 400micrograms of folic acid.~acetylsalicylic-acid (aspirin): 81mg of low-dose aspirin plus 400micrograms of folic acid."
457984|NCT00467285|B3|Baseline|Total|Total of all reporting groups
457985|NCT00467285|B2|Baseline|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
457986|NCT00467285|B1|Baseline|Pioglitazone|32 subjects with type 2 diabetes on pioglitazone.
457987|NCT00467285|P2|Participant Flow|Group 2|64 subjects with type 2 diabetes not on pioglitazone, less than 55 years old.
457988|NCT00467285|P1|Participant Flow|Group 1|32 subjects with type 2 diabetes on pioglitazone.
457989|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
457990|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
457991|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
457992|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
457993|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
457994|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
457995|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
457996|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
457997|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
457998|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
457999|NCT00467285|O2|Outcome|Baseline Characteristics: Group 2|Mean age of 49 with mean BMI 0f 35.2 ± 5; HbA1C of 7.45
458000|NCT00467285|O1|Outcome|Baseline Characteristics: Group 1|Mean age of 49 with mean BMI 0f 33.6 ± 5; HbA1C of 7.54
458001|NCT00467285|O2|Outcome|No Pioglitazone|64 subjects with type 2 diabetes not on pioglitazone
458002|NCT00467285|O1|Outcome|Piogliazone|32 Subjects with type 2 diabetes on Pioglitazone
458003|NCT00467285|E2|Reported Event|No Pioglitazone|Subjects not on pioglitazone
458004|NCT00467285|E1|Reported Event|Pioglitazone|Subjects on pioglitazone
458005|NCT00467259|B3|Baseline|Total|Total of all reporting groups
458006|NCT00467259|B2|Baseline|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458007|NCT00467259|B1|Baseline|Placebo|Placebo patch
458008|NCT00467259|P2|Participant Flow|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458009|NCT00467259|P1|Participant Flow|Placebo|Placebo patch
458010|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458011|NCT00467259|O1|Outcome|Placebo|Placebo patch
458012|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458013|NCT00467259|O1|Outcome|Placebo|Placebo patch
458014|NCT00467259|O2|Outcome|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458015|NCT00467259|O1|Outcome|Placebo|Placebo patch
458016|NCT00467259|E2|Reported Event|Testosterone|Testosterone patch, 300 mcg/day, change patch twice a week for 52 weeks
458017|NCT00467259|E1|Reported Event|Placebo|Placebo patch
458018|NCT00467051|B1|Baseline|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
458019|NCT00467051|P1|Participant Flow|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
458043|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458020|NCT00467051|O1|Outcome|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
458021|NCT00467051|E1|Reported Event|Treatment (Chemotherapy, Biological Therapy)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 1 hour on day 1 and ifosfamide IV over 1 hour on days 1-5. Beginning on day 6, patients receive filgrastim (G-CSF) subcutaneously or IV once daily until blood count returns to normal. Treatment repeats every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV dosage 135 mg/m2/dose~carboplatin: Given IV dosage in mg/m2 = Target AUC (mg•min/mL) x [(0.93 x GFR mL/min/m2) + 15]= 6.5 x [(0.93 x GFR mL/min/m2) + 15]. (BSA = body surface area in square meters). GFR is reported in institutions as uncorrected or raw (not normalized to BSA) or corrected. This number needs to be converted to GFR in mL/min/m2.~ifosfamide: Given IV dosage 1800 mg/m2/dose~filgrastim: Given IV or subcutaneously dosage 1,080mg/m2/day divided to three equal doses of 360mg/m2~laboratory biomarker analysis: Optional correlative studies"
458022|NCT00467038|B3|Baseline|Total|Total of all reporting groups
458023|NCT00467038|B2|Baseline|Healthy Controls|"Healthy controls~Age and gender matched healthy volunteers"
458024|NCT00467038|B1|Baseline|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD~Event-related fMRI was obtained pre- and post-12-months of standard-DBT in unmedicatedBPD patients."
458025|NCT00467038|P2|Participant Flow|Healthy Controls|Healthy controls- no intervention
458026|NCT00467038|P1|Participant Flow|Dialectical Behavior Therapy|Participants receiving Dialectical Behavior Therapy
458027|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
458028|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD
458029|NCT00467038|O2|Outcome|Healthy Controls|Healthy controls age- and gender-matched to other group of participants
458030|NCT00467038|O1|Outcome|Dialectical Behavior Therapy|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
458031|NCT00467038|E2|Reported Event|Arm 2|Healthy controls- no intervention
458032|NCT00467038|E1|Reported Event|Arm 1|"Dialectical Behavior Therapy~Dialectical Behavior: Dialectical Behavior Therapy is an empirically validated treatment approach emphasizing the role of emotion regulation in the treatment of suicidal and self-destructive behaviors in BPD"
458033|NCT00466947|B3|Baseline|Total|Total of all reporting groups
458034|NCT00466947|B2|Baseline|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458035|NCT00466947|B1|Baseline|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458036|NCT00466947|P2|Participant Flow|Control Group|Subjects received 3 doses of Engerix at 2,4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccine were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458037|NCT00466947|P1|Participant Flow|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458038|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458039|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458040|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458041|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458042|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458642|NCT00465101|O1|Outcome|Total Energy Delivered|
458044|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458045|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458046|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458047|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458048|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458049|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458050|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458051|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458052|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458053|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458054|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458055|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458056|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458057|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458058|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458059|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458060|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458061|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458062|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458063|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458064|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458065|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458066|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458067|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458068|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458069|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458070|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458071|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458072|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458073|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458074|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458075|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458076|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458077|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458078|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458079|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458080|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458081|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458082|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458083|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458084|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458085|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458086|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458087|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458088|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458089|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458090|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458091|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458092|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458093|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458094|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458095|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458096|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458097|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458098|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458099|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458100|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458101|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458102|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458103|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458104|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458105|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458106|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458107|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458108|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458109|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458110|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458111|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458112|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458113|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458114|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458115|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458116|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458117|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458118|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458119|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458120|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458121|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458122|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458123|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458124|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458125|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458126|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458127|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458128|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458129|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458130|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458131|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458132|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458133|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458134|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458135|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458136|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458137|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458138|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458139|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458140|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458141|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458142|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458143|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458144|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458145|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458146|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458147|NCT00466947|O1|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458148|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458149|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458150|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458151|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458152|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458153|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458154|NCT00466947|O2|Outcome|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458155|NCT00466947|O1|Outcome|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458156|NCT00466947|E2|Reported Event|Control Group|Subjects received 3 doses of Engerix at 2, 4 and 6 months of age co-administered with Infanrix-IPV/Hib and 1 dose of Havrix co-administered with Infanrix-IPV/Hib at 15-18 months of age. All vaccines were administered in the right (Engerix, Havrix) or the left (Infanrix-IPV/Hib) thigh.
458157|NCT00466947|E1|Reported Event|Synflorix Group|Subjects received 3 primary doses of Synflorix at 2, 4 and 6 months of age co-administered with Infanrix-hexa and booster dose of Synflorix at 15-18 months of age co-administered with Infanrix-IPV/Hib. All vaccines were administered intramuscularly in the right (Synflorix) or the left (Infanrix-hexa, Infanrix-IPV/Hib) thigh (primary dose) or deltoid (booster dose).
458158|NCT00466882|B1|Baseline|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
458159|NCT00466882|P1|Participant Flow|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
458160|NCT00466882|O1|Outcome|Group 1|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
458161|NCT00466882|E1|Reported Event|Group 1 Inamed Lap-Band System|The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
458162|NCT00466817|B3|Baseline|Total|Total of all reporting groups
458163|NCT00466817|B2|Baseline|Valganciclovir: 24 Wks of Valganciclovir|"Six months (6 weeks open label, 18 weeks blinded) of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458368|NCT00465985|P1|Participant Flow|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458164|NCT00466817|B1|Baseline|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo (18 weeks) to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458165|NCT00466817|P2|Participant Flow|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458166|NCT00466817|P1|Participant Flow|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458167|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458168|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458169|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458170|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458171|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458172|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458173|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Vlaganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458174|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458175|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458176|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458177|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458178|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458179|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458180|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458218|NCT00466687|B1|Baseline|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
458181|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458182|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458183|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458184|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458185|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458186|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458187|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458188|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458189|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458190|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458191|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458192|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458193|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458194|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458195|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458196|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458197|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458219|NCT00466687|P1|Participant Flow|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
458198|NCT00466817|O1|Outcome|Placebo: 6 Wks of Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458199|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458200|NCT00466817|O1|Outcome|Placebo: 6 Wks of Vlaganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458201|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458202|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458203|NCT00466817|O2|Outcome|Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458204|NCT00466817|O1|Outcome|Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458205|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458206|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458207|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458208|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458209|NCT00466817|O2|Outcome|Valganciclovir: 24 Weeks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458210|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks of Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458211|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458212|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458213|NCT00466817|O2|Outcome|Valganciclovir: 24 Wks of Valganciclovir|"Six months of oral Valganciclovir.~Valganciclovir : Mono-valyl ester pro-drug of ganciclovir, oral solution, provided as a 12 grams of powder containing 5 grams of Valganciclovir free base. The oral solution formulation comprises the following excipients: Providone K30, fumaric acid, sodium benzoate, sodium saccharin, mannitol, flavor, and purified water."
458214|NCT00466817|O1|Outcome|Placebo: 6 Wks Valganciclovir Followed by 18 Wks Placebo|"Six weeks of oral Valganciclovir followed by placebo to complete the six month time period.~Placebo : 9 grams of powder which contains no Valganciclovir free base. The oral solution formulation comprises the following excipients: mannitol, lactose anhydrous, fumaric acid, sodium benzoate, saccharin sodium, flavor, and purified water."
458215|NCT00466817|E3|Reported Event|Placebo After 6 Weeks of Valganciclovir|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded placebo
458216|NCT00466817|E2|Reported Event|Active|6 weeks of open labeled vanganciclovir followed by 4 1/2 months of blinded valganciclovir
458217|NCT00466817|E1|Reported Event|Non Randomized|6 weeks of open label valganciclovir only
458220|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
458221|NCT00466687|O1|Outcome|Therapeutic Intervention|Study drugs are administered on a 28-day cycle: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
458222|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
458223|NCT00466687|O1|Outcome|Tarceva/Avastin|Study drugs are administered on a 28-day cycle for 6 cycles: Tarceva 150 mg by mouth per day and Avastin 10 mg/kg of body weight intravenously (IV) on days 1 and 15.
458224|NCT00466687|E1|Reported Event|Therapeutic Intervention|Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
458225|NCT00466505|B1|Baseline|Therapeutic Intervention|
458226|NCT00466505|P1|Participant Flow|Therapeutic Intervention|
458227|NCT00466505|O1|Outcome|Therapeutic Intervention|
458228|NCT00466505|O1|Outcome|Therapeutic Intervention|
458229|NCT00466505|O1|Outcome|Therapeutic Intervention|
458230|NCT00466505|O1|Outcome|Therapeutic Intervention|
458231|NCT00466505|O1|Outcome|Therapeutic Intervention|
458232|NCT00466505|O1|Outcome|Therapeutic Intervention|
458233|NCT00466505|O1|Outcome|Therapeutic Intervention|
458234|NCT00466505|O1|Outcome|Therapeutic Intervention|
458235|NCT00466505|O1|Outcome|Therapeutic Intervention|
458236|NCT00466505|E1|Reported Event|Therapeutic Intervention|
458237|NCT00466323|B3|Baseline|Total|Total of all reporting groups
458238|NCT00466323|B2|Baseline|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458239|NCT00466323|B1|Baseline|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458240|NCT00466323|P2|Participant Flow|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458241|NCT00466323|P1|Participant Flow|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458242|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458243|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458244|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458245|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458246|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458247|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458248|NCT00466323|O2|Outcome|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458249|NCT00466323|O1|Outcome|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458299|NCT00466193|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458250|NCT00466323|E2|Reported Event|Enhanced Treatment as Usual (e-TAU)|"Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team.~Enhanced treatment as usual (e-TAU): Enhanced treatment as usual. In this condition, the consumer is given a list of family services available including the family intervention team."
458251|NCT00466323|E1|Reported Event|FMPO Condition|"Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission.~Family Member Provider Outreach: Family Member Provider Outreach is a brief recovery oriented model. THe FMPO meets with the consumer for 2-3 sessions and with the family for 2-3 sessions with the consumer's permission."
458252|NCT00466310|B4|Baseline|Total|Total of all reporting groups
458253|NCT00466310|B3|Baseline|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
458254|NCT00466310|B2|Baseline|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
458255|NCT00466310|B1|Baseline|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
458256|NCT00466310|P3|Participant Flow|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
458257|NCT00466310|P2|Participant Flow|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
458258|NCT00466310|P1|Participant Flow|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
458259|NCT00466310|O3|Outcome|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
458260|NCT00466310|O2|Outcome|Recurrent Episode Schizophrenics|Schizophrenia subjects with at least one prior episode
458261|NCT00466310|O1|Outcome|First Episode Schizophrenics|Schizophrenia subjects with no prior episodes
458262|NCT00466310|E3|Reported Event|Healthy Volunteers|Fasting blood samples were drawn at baseline from 31 healthy matched controls.
458263|NCT00466310|E2|Reported Event|Recurrent Episode Schizophrenics|These subjects have had at least one prior schizophrenic episode.
458264|NCT00466310|E1|Reported Event|First Episode Schizophrenics|These are subjects with no prior schizophrenic episodes
458265|NCT00466206|B1|Baseline|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
458266|NCT00466206|P1|Participant Flow|3MP Treatment Arm|Undergo active Magnetic Mini-Mover Procedure for treatment of pectus excavatum. Active treatment = 18 months
458267|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
458268|NCT00466206|O1|Outcome|3MP Treatment Arm|Pectus excavatum treated with Magnetic Mini-Mover Procedure. Active treatment = 18 months
458269|NCT00466206|O1|Outcome|3MP Treatment Group|Treatment of pectus excavatum with the Magnetic Mini-Mover Procedure
458270|NCT00466206|O1|Outcome|Treatment Arm|Magnetic Mini-Mover Procedure
458271|NCT00466206|O1|Outcome|Magnetic Mini-Mover Group|Treatment for pectus excavatum using Magnimplant and Magnatract
458272|NCT00466206|E1|Reported Event|Magnetic Mini-Mover Treatment|Use of the Magnimplant and Magnatract to treat pectus excavatum
458273|NCT00466193|B3|Baseline|Total|Total of all reporting groups
458274|NCT00466193|B2|Baseline|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458275|NCT00466193|B1|Baseline|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458276|NCT00466193|P2|Participant Flow|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458277|NCT00466193|P1|Participant Flow|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458278|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458279|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458280|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458281|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458282|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458283|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458284|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458285|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458286|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458287|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458288|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458289|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458290|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458291|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458292|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458293|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458294|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458295|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458296|NCT00466193|O2|Outcome|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458297|NCT00466193|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet, 3.5 milligram, taken following a middle-of-the-night awakening.
458298|NCT00466193|E2|Reported Event|Placebo|Placebo sublingual tablet taken following a middle-of-the-night awakening.
458301|NCT00466167|B3|Baseline|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458302|NCT00466167|B2|Baseline|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458303|NCT00466167|B1|Baseline|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458304|NCT00466167|P3|Participant Flow|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458305|NCT00466167|P2|Participant Flow|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458306|NCT00466167|P1|Participant Flow|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458307|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458308|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458309|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458310|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458311|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458312|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458313|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458314|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458315|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458316|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458317|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458318|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458319|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458320|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458321|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458369|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458370|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
458322|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458323|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458324|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458325|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458326|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458327|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458328|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458329|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458330|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458331|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458332|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458333|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458334|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458335|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458336|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458337|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458338|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458339|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458340|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458341|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458342|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458371|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458372|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458343|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458344|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458345|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458346|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458347|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458348|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458349|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458350|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458351|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458352|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458353|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458354|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458355|NCT00466167|O3|Outcome|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458356|NCT00466167|O2|Outcome|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458357|NCT00466167|O1|Outcome|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458358|NCT00466167|E3|Reported Event|Pramipexole IR|"Pramipexole Immediate Release (IR) (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day"
458359|NCT00466167|E2|Reported Event|Pramipexole ER|Pramipexole Extended Release (ER) (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning
458360|NCT00466167|E1|Reported Event|Placebo|"Matching Placebo to Pramipexole IR (tablets of 0.125mg, 0.25mg, 0.5mg, 1.0mg and 1.5mg), dose: 0.375mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, in equally divided doses 3 times per day~Matching Placebo to Pramipexole ER (tablets of 0.375mg, 0.75mg, 1.5mg, 3.0mg or 4.5mg), dose: 0.375 mg, 0.75mg, 1.5mg, 2.25mg, 3.0mg, 3.75mg, or 4.5mg, mode of administration: Per os, once a day, in the morning"
458361|NCT00465998|B1|Baseline|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
458362|NCT00465998|P1|Participant Flow|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
458363|NCT00465998|O1|Outcome|Time From Induction to Delivery|Variables associated to time from induction to delivery were investigated.
458364|NCT00465998|O1|Outcome|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
458365|NCT00465998|E1|Reported Event|Successful Vaginal Delivery|"275 women with induced labors were included in the study, and the main outcome was vaginal delivery.~Variables associated to a successful vaginal delivery was examined."
458366|NCT00465985|B1|Baseline|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458367|NCT00465985|P2|Participant Flow|Placebo|Placebo subcutaneous injection every 8 weeks.
458374|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458375|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458376|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
458377|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458378|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
458379|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458380|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458381|NCT00465985|O2|Outcome|Placebo|Placebo subcutaneous injection every 8 weeks.
458382|NCT00465985|O1|Outcome|ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458383|NCT00465985|E5|Reported Event|Entire Study ACZ885|Entire study ACZ885. The SAE and AEs were collected and reported for all three periods.
458384|NCT00465985|E4|Reported Event|Part III ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458385|NCT00465985|E3|Reported Event|Part II Placebo|Placebo subcutaneous injection every 8 weeks.
458386|NCT00465985|E2|Reported Event|Part II ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458387|NCT00465985|E1|Reported Event|Part I ACZ885|ACZ885 150 mg subcutaneous injection or 2 mg/kg subcutaneous injection, depending on body weight, every 8 weeks.
458388|NCT00465972|B3|Baseline|Total|Total of all reporting groups
458389|NCT00465972|B2|Baseline|Temazepam|1 15 mg pill taken nightly at bedtime.
458390|NCT00465972|B1|Baseline|Placebo|1 sugar pill taken nightly at bedtime.
458391|NCT00465972|P2|Participant Flow|Temazepam|One 15 mg temazepam pill taken orally at bedtime for the duration of the participant's involvement.
458392|NCT00465972|P1|Participant Flow|Placebo|One sugar pill taken orally at bedtime for duration of the participant's involvement.
458393|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill taken nightly at bedtime.
458394|NCT00465972|O1|Outcome|Placebo|1 sugar taken nightly at bedtime.
458395|NCT00465972|O2|Outcome|Temazepam|1 15 mg pill of temazepam taken orally at bedtime.
458396|NCT00465972|O1|Outcome|Placebo|1 sugar pill taken orally at bedtime.
458397|NCT00465972|E2|Reported Event|Temazepam|1 15 mg pill taken orally, nightly, at bedtime.
458398|NCT00465972|E1|Reported Event|Placebo|1 sugar pill taken nightly at bedtime.
458399|NCT00465894|B3|Baseline|Total|Total of all reporting groups
458400|NCT00465894|B2|Baseline|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
458401|NCT00465894|B1|Baseline|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
458402|NCT00465894|P2|Participant Flow|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
458403|NCT00465894|P1|Participant Flow|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
458404|NCT00465894|O2|Outcome|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
458405|NCT00465894|O1|Outcome|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12 weeks
458406|NCT00465894|E2|Reported Event|Group 2: Intra Vaginal Estradiol Cream|0.5 grams of Intra vaginal estradiol cream nightly for 6 weeks, then twice weekly for 6 weeks
458407|NCT00465894|E1|Reported Event|Group 1: Extended Release Tolterodine|4 mg Tolterodine po daily for 12-weeks
458408|NCT00465816|B4|Baseline|Total|Total of all reporting groups
458409|NCT00465816|B3|Baseline|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458410|NCT00465816|B2|Baseline|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458411|NCT00465816|B1|Baseline|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458412|NCT00465816|P3|Participant Flow|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458413|NCT00465816|P2|Participant Flow|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458414|NCT00465816|P1|Participant Flow|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458415|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458416|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458417|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458418|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458419|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458420|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458421|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458422|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458423|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458424|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458425|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458426|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458427|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458429|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458430|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458431|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458432|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458433|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458434|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458435|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458436|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458437|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458438|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458439|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458440|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458441|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458442|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458443|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458444|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458445|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458446|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458447|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458448|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458449|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458450|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458451|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458452|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458453|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458454|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458455|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458456|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458457|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458458|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458459|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458460|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458461|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458462|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458463|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458464|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458465|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458466|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458467|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458468|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458469|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458470|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458471|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458472|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458473|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458474|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458475|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458476|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458477|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458478|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458479|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458480|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458481|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458482|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458483|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458484|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458485|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458486|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458487|NCT00465816|O3|Outcome|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458488|NCT00465816|O2|Outcome|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458489|NCT00465816|O1|Outcome|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458490|NCT00465816|E3|Reported Event|Twinrix Group|Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458491|NCT00465816|E2|Reported Event|Nimenrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
458492|NCT00465816|E1|Reported Event|Nimenrix + Twinrix Group|Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
458493|NCT00465738|B3|Baseline|Total|Total of all reporting groups
458494|NCT00465738|B2|Baseline|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458495|NCT00465738|B1|Baseline|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458496|NCT00465738|P2|Participant Flow|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458497|NCT00465738|P1|Participant Flow|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458498|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458499|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458500|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458501|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458502|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458503|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458504|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458505|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458506|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458507|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458508|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458509|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458510|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458511|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458512|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458513|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458514|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458515|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458516|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458517|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458518|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458519|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458520|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458521|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458522|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458523|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458524|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458525|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458526|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458527|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458528|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458529|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458530|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458531|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458532|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458533|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458534|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458535|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458536|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458537|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458538|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458539|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458540|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458541|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458542|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458543|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458544|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458545|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458546|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458547|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458548|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458549|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458550|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458551|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458552|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458553|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458554|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458555|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458556|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458557|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458558|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458559|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458560|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458561|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458562|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458563|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458564|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458565|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458566|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458567|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458568|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458569|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458570|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458571|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458572|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458573|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458574|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458575|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458576|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458577|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458578|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458579|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458580|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458581|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458582|NCT00465738|O2|Outcome|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458583|NCT00465738|O1|Outcome|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458584|NCT00465738|E2|Reported Event|incobotulinumtoxinA (Xeomin) Low-volume Dilution 50 Units/mL|
458585|NCT00465738|E1|Reported Event|incobotulinumtoxinA (Xeomin) High-volume Dilution 20 Units/mL|
458586|NCT00465647|B5|Baseline|Total|Total of all reporting groups
458587|NCT00465647|B4|Baseline|≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458588|NCT00465647|B3|Baseline|≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458589|NCT00465647|B2|Baseline|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458590|NCT00465647|B1|Baseline|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458591|NCT00465647|P4|Participant Flow|≥ 12 Years to < 17 Years|Adolescent- received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458592|NCT00465647|P3|Participant Flow|≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458593|NCT00465647|P2|Participant Flow|≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458594|NCT00465647|P1|Participant Flow|≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458595|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458643|NCT00465101|O1|Outcome|Number of Fibers Used|
458596|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child (Data for this group not collected. Test not appropriate for this age)
458597|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child (Data for this group not collected. Test not appropriate for this age)
458598|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
458599|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
458600|NCT00465647|O3|Outcome|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458601|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458602|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler (Data for this group not collected. Test not appropriate for this age)
458603|NCT00465647|O4|Outcome|Oral ≥ 12 Years to < 17 Years|Adolescent (Data for this group not collected. Test not appropriate for this age)
458604|NCT00465647|O3|Outcome|Oral ≥ 5 Years to < 12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458605|NCT00465647|O2|Outcome|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458606|NCT00465647|O1|Outcome|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458607|NCT00465647|O1|Outcome|All Patients|A total of all 4 age groups: infant and toddler, young child, older child, and adolescent.
458608|NCT00465647|E8|Reported Event|Parenteral ≥ 12 Years to < 17 Years|Adolescent - received parenteral analgesia up to 48 hours postsurgery.
458609|NCT00465647|E7|Reported Event|Parenteral ≥ 5 Years to < 12 Years|Older child - received parenteral analgesia up to 48 hours postsurgery.
458610|NCT00465647|E6|Reported Event|Parenteral ≥ 13 Months to < 5 Years|Young child - received parenteral analgesia up to 48 hours postsurgery.
458611|NCT00465647|E5|Reported Event|Parenteral ≥ 28 Days to < 13 Months|Infant and toddler - received parenteral analgesia up to 48 hours postsurgery.
458612|NCT00465647|E4|Reported Event|Oral ≥ 12 Years to < 17 Years|Adolescent - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458613|NCT00465647|E3|Reported Event|Oral ≥ 5 Years to <12 Years|Older child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458614|NCT00465647|E2|Reported Event|Oral ≥ 13 Months to < 5 Years|Young child - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458615|NCT00465647|E1|Reported Event|Oral ≥ 28 Days to < 13 Months|Infant and toddler - received oral hydromorphone HCl every 6 hours, for a total of up to 9 doses, according to the dosing schedule. Starting doses were determined based on weight for this age group.
458616|NCT00465530|B3|Baseline|Total|Total of all reporting groups
458617|NCT00465530|B2|Baseline|Saline (Once Daily, 40 mL to Each Nostril)|
458618|NCT00465530|B1|Baseline|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
458619|NCT00465530|P2|Participant Flow|Saline (Once Daily, 40 mL to Each Nostril)|
458620|NCT00465530|P1|Participant Flow|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
458621|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
458622|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
458623|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
458624|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
458625|NCT00465530|O2|Outcome|Saline Plus Gentamicin (Once Daily, 40 mL to Each Nostril)|
458626|NCT00465530|O1|Outcome|Saline (Once Daily, 40 mL to Each Nostril)|
458627|NCT00465530|E2|Reported Event|Saline (Once Daily, 40 mL to Each Nostril)|
458628|NCT00465530|E1|Reported Event|Saline Plus Gentamycin (Once Daily, 40 mL to Each Nostril)|
458629|NCT00465361|B1|Baseline|Intervention|Performance after receiving feedback and educational module
458630|NCT00465361|P1|Participant Flow|Intervention|Performance after receiving feedback and educational module
458631|NCT00465361|O1|Outcome|Intervention|Performance after receiving feedback and educational module
458632|NCT00465361|E1|Reported Event|Intervention|Performance after receiving feedback and educational module
458633|NCT00465179|B1|Baseline|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458634|NCT00465179|P1|Participant Flow|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458635|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458636|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458637|NCT00465179|O1|Outcome|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458638|NCT00465179|E1|Reported Event|Sunitinib Malate|Sunitinib Malate 50 mg by mouth daily for 4 weeks, then 2 weeks off. These 6 weeks are considered 1 cycle of study treatment.
458639|NCT00465101|B1|Baseline|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
458640|NCT00465101|P1|Participant Flow|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
458641|NCT00465101|O1|Outcome|Retrograde Ejaculation Occurrence Rate|
458667|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
458668|NCT00465101|O1|Outcome|Number of Subjects With Baseline and 6 Month Values|The total number of patients that treated equals 136; the total number of patients with Baseline and 6 month values equals 117.
458669|NCT00465101|O1|Outcome|Treatment Related Complication at 3 Months|
458670|NCT00465101|O1|Outcome|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
458671|NCT00465101|E1|Reported Event|GreenLight HPS Laser System|GreenLight HPS Laser System therapy for patients with BPH.
458672|NCT00465088|B3|Baseline|Total|Total of all reporting groups
458673|NCT00465088|B2|Baseline|Atorvastatin|40 mg atorvastatin once daily at bedtime
458674|NCT00465088|B1|Baseline|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458675|NCT00465088|P2|Participant Flow|Atorvastatin|40 mg atorvastatin once daily at bedtime
458676|NCT00465088|P1|Participant Flow|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458677|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458678|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458679|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458680|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458681|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458682|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458683|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458684|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458685|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458686|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458687|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458688|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458689|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458690|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458691|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458692|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458693|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458694|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458695|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458696|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458697|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458698|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458699|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458700|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458701|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458702|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458703|NCT00465088|O2|Outcome|Atorvastatin|40 mg atorvastatin once daily at bedtime
458704|NCT00465088|O1|Outcome|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458705|NCT00465088|E2|Reported Event|Atorvastatin|40 mg atorvastatin once daily at bedtime
458706|NCT00465088|E1|Reported Event|Niacin Extended-release Plus Simvastatin|Up to 2000 mg of niacin extended-release plus 40 mg simvastatin once daily at bedtime
458707|NCT00464945|B3|Baseline|Total|Total of all reporting groups
458708|NCT00464945|B2|Baseline|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458709|NCT00464945|B1|Baseline|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458732|NCT00464945|E6|Reported Event|13vPnC Pilot Toddler Series|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458993|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
458710|NCT00464945|P2|Participant Flow|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458711|NCT00464945|P1|Participant Flow|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458712|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
458713|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
458714|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458715|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458716|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458717|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458718|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458719|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458720|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
458721|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
458722|NCT00464945|O8|Outcome|13vPnC Pilot Toddler Dose|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458723|NCT00464945|O7|Outcome|13vPnC Manufacturing Toddler Dose|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458724|NCT00464945|O6|Outcome|13vPnC Pilot Dose 3|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458725|NCT00464945|O5|Outcome|13vPnC Manufacturing Dose 3|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458726|NCT00464945|O4|Outcome|13vPnC Pilot Dose 2|Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458727|NCT00464945|O3|Outcome|13vPnC Manufacturing Dose 2|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458728|NCT00464945|O2|Outcome|13vPnC Pilot Dose 1|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
458729|NCT00464945|O1|Outcome|13vPnC Manufacturing Dose 1|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1).
458730|NCT00464945|O2|Outcome|13vPnC Pilot|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458731|NCT00464945|O1|Outcome|13vPnC Manufacturing|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458733|NCT00464945|E5|Reported Event|13vPnC Manufacturing Toddler Series|Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with measles, mumps, and rubella vaccine (MMR) and 12 months of age (toddler dose).
458734|NCT00464945|E4|Reported Event|13vPnC Pilot Post-Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
458735|NCT00464945|E3|Reported Event|13vPnC Manufacturing Post-Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3). Assessment done at 5 months of age, 1 month after infant series.
458736|NCT00464945|E2|Reported Event|13vPnC Pilot Infant Series|Participants received one single 0.5mL pilot scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL pilot scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458737|NCT00464945|E1|Reported Event|13vPnC Manufacturing Infant Series|Participants received one single 0.5mL manufacturing scale dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined diphtheria, tetanus, and acellular pertussis inactivated poliovirus, and hemophilus influenza type b vaccine (DTaP-IPV-Hib) and hepatitis B virus vaccine (HBV) at 2 months (infant series, dose 1). Participants received one single 0.5mL manufacturing scale dose of 13vPnC coadministered with DTaP-IPV-Hib at 3 and 4 months (infant series, dose 2 and 3).
458738|NCT00464737|B4|Baseline|Total|Total of all reporting groups
458739|NCT00464737|B3|Baseline|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458740|NCT00464737|B2|Baseline|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458741|NCT00464737|B1|Baseline|Placebo|Placebo
458742|NCT00464737|P3|Participant Flow|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458743|NCT00464737|P2|Participant Flow|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458744|NCT00464737|P1|Participant Flow|Placebo|Placebo
458745|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458746|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458747|NCT00464737|O1|Outcome|Placebo|Placebo
458748|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458749|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458750|NCT00464737|O1|Outcome|Placebo|Placebo
458751|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458752|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458753|NCT00464737|O1|Outcome|Placebo|Placebo
458754|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458755|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458756|NCT00464737|O1|Outcome|Placebo|Placebo
458757|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458758|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458759|NCT00464737|O1|Outcome|Placebo|Placebo
458760|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458761|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458762|NCT00464737|O1|Outcome|Placebo|Placebo
458763|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458764|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458765|NCT00464737|O1|Outcome|Placebo|Placebo
458766|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458767|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458768|NCT00464737|O1|Outcome|Placebo|Placebo
458769|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458770|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458771|NCT00464737|O1|Outcome|Placebo|Placebo
458772|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458773|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458774|NCT00464737|O1|Outcome|Placebo|Placebo
458775|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458776|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458777|NCT00464737|O1|Outcome|Placebo|Placebo
458778|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458779|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458780|NCT00464737|O1|Outcome|Placebo|Placebo
458781|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458782|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458783|NCT00464737|O1|Outcome|Placebo|Placebo
458784|NCT00464737|O3|Outcome|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458785|NCT00464737|O2|Outcome|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458786|NCT00464737|O1|Outcome|Placebo|Placebo
458787|NCT00464737|E3|Reported Event|Rotigotine 8 mg|Rotigotine 8 mg/24 hrs
458788|NCT00464737|E2|Reported Event|Rotigotine 4 mg|Rotigotine 4 mg/24 hrs
458789|NCT00464737|E1|Reported Event|Placebo|Placebo
458790|NCT00464711|B1|Baseline|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
458791|NCT00464711|P1|Participant Flow|Escitalopram|40 subjects met inclusion/exclusion criteria and started treatment with escitalopram
458792|NCT00464711|O1|Outcome|Open Label Escitalopram|All subjects were treated with open label escitalopram
458793|NCT00464711|E1|Reported Event|Escitalopram|40 subjects met inclusion/exclusion criteria and started study treatment
458794|NCT00464685|B3|Baseline|Total|Total of all reporting groups
458795|NCT00464685|B2|Baseline|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458796|NCT00464685|B1|Baseline|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458797|NCT00464685|P2|Participant Flow|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458798|NCT00464685|P1|Participant Flow|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458799|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458800|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458801|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458802|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458803|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458804|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458805|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458806|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458807|NCT00464685|O2|Outcome|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458808|NCT00464685|O1|Outcome|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458809|NCT00464685|E2|Reported Event|Sham Implant and Laser Photocoagulation|Initial sham injection with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458810|NCT00464685|E1|Reported Event|700 µg Dexamethasone Implant and Laser Photocoagulation|Initial intravitreal injection of 700 µg dexamethasone with up to 1 additional treatment based on re-treatment criteria. Initial laser photocoagulation with up to 3 additional treatments based on re-treatment criteria.
458811|NCT00464672|B3|Baseline|Total|Total of all reporting groups
458812|NCT00464672|B2|Baseline|Comparator Influenza Vaccine|Injections of the comparator influenza vaccine were administered intramuscularly
458813|NCT00464672|B1|Baseline|Influenza Virus Vaccine|Injections of the investigational influenza virus vaccine were administered intramuscularly
458814|NCT00464672|P6|Participant Flow|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
458815|NCT00464672|P5|Participant Flow|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458816|NCT00464672|P4|Participant Flow|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
458817|NCT00464672|P3|Participant Flow|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458818|NCT00464672|P2|Participant Flow|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
458819|NCT00464672|P1|Participant Flow|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458820|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458821|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458822|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458823|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458824|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458825|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458826|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (Injection 2)|Injections of the comparator influenza vaccine were administered intramuscularly.
458827|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Injection 2)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
458828|NCT00464672|O2|Outcome|Comparator Influenza Vaccine (Injection 1)|Injections of the comparator influenza vaccine were administered intramuscularly.
458829|NCT00464672|O1|Outcome|Influenza Virus Vaccine (Injection 1)|Injections of the investigational influenza virus vaccine were administered intramuscularly.
458830|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
458831|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
458832|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
458833|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458834|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458835|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458836|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
458837|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
458838|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
458839|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458840|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458841|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458842|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|Two injections of the comparator influenza vaccine were administered intramuscularly
458843|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|Two injections of the comparator influenza vaccine were administered intramuscularly
458844|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|Two injections of the comparator influenza vaccine were administered intramuscularly
458845|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458846|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458847|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458848|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|Injection of the comparator influenza vaccine were administered intramuscularly
458849|NCT00464672|O1|Outcome|Influenza Virus Vaccine|Injection of the investigational influenza virus vaccine were administered intramuscularly
458850|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458851|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458852|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458853|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458854|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458855|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458856|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458857|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458858|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458859|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458860|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458861|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458862|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458863|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458864|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458865|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458866|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458867|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458868|NCT00464672|O2|Outcome|Comparator Influenza Vaccine|One injection of the comparator influenza vaccine was administered intramuscularly
458869|NCT00464672|O1|Outcome|Influenza Virus Vaccine|One injection of the investigational influenza virus vaccine was administered intramuscularly
458870|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458871|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458872|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458873|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458874|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458875|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458876|NCT00464672|O6|Outcome|Comparator Influenza Vaccine (Strain B)|One injection of the comparator influenza vaccine was administered intramuscularly
458877|NCT00464672|O5|Outcome|Comparator Influenza Vaccine (A/H3N2)|One injection of the comparator influenza vaccine was administered intramuscularly
458878|NCT00464672|O4|Outcome|Comparator Influenza Vaccine (A/H1N1)|One injection of the comparator influenza vaccine was administered intramuscularly
458879|NCT00464672|O3|Outcome|Influenza Virus Vaccine (Strain B)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458880|NCT00464672|O2|Outcome|Influenza Virus Vaccine (A/H3N2)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458881|NCT00464672|O1|Outcome|Influenza Virus Vaccine (A/H1N1)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458882|NCT00464672|E6|Reported Event|Comparator Influenza Vaccine (3 to 8 Years)|Two injections of the comparator influenza vaccine were administered intramuscularly
458883|NCT00464672|E5|Reported Event|Influenza Virus Vaccine (3 to 8 Years)|Two injections of the investigational influenza virus vaccine were administered intramuscularly
458884|NCT00464672|E4|Reported Event|Comparator Influenza Vaccine (9 to 17 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
458885|NCT00464672|E3|Reported Event|Influenza Virus Vaccine (9 to 17 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458886|NCT00464672|E2|Reported Event|Comparator Influenza Vaccine (18 to 64 Years)|One injection of the comparator influenza vaccine was administered intramuscularly
458887|NCT00464672|E1|Reported Event|Influenza Virus Vaccine (18 to 64 Years)|One injection of the investigational influenza virus vaccine was administered intramuscularly
458888|NCT00464646|B3|Baseline|Total|Total of all reporting groups
458889|NCT00464646|B2|Baseline|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
458890|NCT00464646|B1|Baseline|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
458891|NCT00464646|P2|Participant Flow|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
458892|NCT00464646|P1|Participant Flow|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
458893|NCT00464646|O2|Outcome|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
458894|NCT00464646|O1|Outcome|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
458895|NCT00464646|E2|Reported Event|Cohort B|• Cohort B: Women with resected pN2 or pN3 (pathologic Stage III) breast cancer
458896|NCT00464646|E1|Reported Event|Cohort A|• Cohort A: Women with unresected locally advanced breast cancer (clinical Stage IIIA, IIIB, and IIIC)
458897|NCT00464542|B1|Baseline|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
458898|NCT00464542|P1|Participant Flow|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
458899|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
458900|NCT00464542|O1|Outcome|Post-treatment MASH Cohort|Women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment and who provided daily vaginal smears for 30 days following cessation of metronidazole therapy
458901|NCT00464542|E1|Reported Event|MASH Cohort|This cohort consisted of women who were seropositive for Herpes Simplex Virus type 2 (HSV-2)and who had asymptomatic bacterial vaginosis as assessed by Amsel's criteria at enrollment
458902|NCT00464490|B3|Baseline|Total|Total of all reporting groups
458903|NCT00464490|B2|Baseline|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
458904|NCT00464490|B1|Baseline|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
458905|NCT00464490|P2|Participant Flow|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
458906|NCT00464490|P1|Participant Flow|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
458907|NCT00464490|O2|Outcome|Standard Hospital Protocol (CG)|Control. Standard hospital weaning protocol
458908|NCT00464490|O1|Outcome|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
458909|NCT00464490|E2|Reported Event|Standard Hospital Protocol (CG)|Control. Hospital weaning per standard protocol
458910|NCT00464490|E1|Reported Event|Dexmedetomidine for Extubation (DG)|"Dexmedomidine infusion to facilitate extubation~Dexmedetomidine: Dexmedetomidine .5mcg/kg/hr-.7mcg/kg/hr 1hour prior to extubation. Dexmedetomidine titrated according to blood pressure, RASS and heart rate response and the dose lowered only after sedation was discontinued or markedly reduced."
458911|NCT00464464|B3|Baseline|Total|Total of all reporting groups
458912|NCT00464464|B2|Baseline|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458913|NCT00464464|B1|Baseline|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458914|NCT00464464|P2|Participant Flow|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458915|NCT00464464|P1|Participant Flow|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458916|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458917|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458918|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458919|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458920|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458921|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458922|NCT00464464|O2|Outcome|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458923|NCT00464464|O1|Outcome|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458924|NCT00464464|E2|Reported Event|Standard Medical Care Condition|"Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial."
458990|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
458991|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
458992|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
458925|NCT00464464|E1|Reported Event|Cognitive-Behavioral Therapy Condition|"Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.~These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial."
458926|NCT00464438|B3|Baseline|Total|Total of all reporting groups
458927|NCT00464438|B2|Baseline|Moxifloxacin 0.5%|
458928|NCT00464438|B1|Baseline|Gatifloxacin 0.3%|
458929|NCT00464438|P2|Participant Flow|Moxifloxacin 0.5%|
458930|NCT00464438|P1|Participant Flow|Gatifloxacin 0.3%|
458931|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
458932|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
458933|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
458934|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
458935|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
458936|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
458937|NCT00464438|O2|Outcome|Moxifloxacin 0.5%|
458938|NCT00464438|O1|Outcome|Gatifloxacin 0.3%|
458939|NCT00464438|E2|Reported Event|Moxifloxacin 0.5%|
458940|NCT00464438|E1|Reported Event|Gatifloxacin 0.3%|
458941|NCT00464334|B12|Baseline|Total|Total of all reporting groups
458942|NCT00464334|B11|Baseline|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458943|NCT00464334|B10|Baseline|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458944|NCT00464334|B9|Baseline|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
458945|NCT00464334|B8|Baseline|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
458946|NCT00464334|B7|Baseline|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
458947|NCT00464334|B6|Baseline|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
458948|NCT00464334|B5|Baseline|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
458949|NCT00464334|B4|Baseline|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
458950|NCT00464334|B3|Baseline|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
458951|NCT00464334|B2|Baseline|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
458952|NCT00464334|B1|Baseline|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
458953|NCT00464334|P11|Participant Flow|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458954|NCT00464334|P10|Participant Flow|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458955|NCT00464334|P9|Participant Flow|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
458956|NCT00464334|P8|Participant Flow|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
458957|NCT00464334|P7|Participant Flow|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
458958|NCT00464334|P6|Participant Flow|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
458959|NCT00464334|P5|Participant Flow|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
458960|NCT00464334|P4|Participant Flow|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
458961|NCT00464334|P3|Participant Flow|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
458962|NCT00464334|P2|Participant Flow|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
458963|NCT00464334|P1|Participant Flow|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/ISCOMATRIX™ (IMX) 0 mcg
458964|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458965|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458966|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
458967|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
458968|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
458969|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
458970|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
458971|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
458972|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
458973|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
458974|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
458975|NCT00464334|O11|Outcome|V950 50 mcg/IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458976|NCT00464334|O10|Outcome|V950 50 mcg/IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458977|NCT00464334|O9|Outcome|V950 5 mcg/IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
458978|NCT00464334|O8|Outcome|V950 5 mcg/IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
458979|NCT00464334|O7|Outcome|V950 5 mcg/IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
458980|NCT00464334|O6|Outcome|V950 0.5 mcg/IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
458981|NCT00464334|O5|Outcome|V950 0.5 mcg/IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
458982|NCT00464334|O4|Outcome|V950 0.5 mcg/IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
458983|NCT00464334|O3|Outcome|V950 0.5 mcg/IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
458984|NCT00464334|O2|Outcome|Placebo to V950/IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
458985|NCT00464334|O1|Outcome|Placebo to V950/IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
458986|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458987|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458988|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
458989|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
458994|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
458995|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
458996|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
458997|NCT00464334|O11|Outcome|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
458998|NCT00464334|O10|Outcome|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
458999|NCT00464334|O9|Outcome|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
459000|NCT00464334|O8|Outcome|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
459001|NCT00464334|O7|Outcome|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
459002|NCT00464334|O6|Outcome|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
459003|NCT00464334|O5|Outcome|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
459004|NCT00464334|O4|Outcome|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
459005|NCT00464334|O3|Outcome|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
459006|NCT00464334|O2|Outcome|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
459007|NCT00464334|O1|Outcome|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
459008|NCT00464334|E11|Reported Event|V950 50 mcg / IMX 16 mcg|Participants receive V950 50 mcg/IMX 16 mcg
459009|NCT00464334|E10|Reported Event|V950 50 mcg / IMX 0 mcg|Participants receive V950 50 mcg/IMX 0 mcg
459010|NCT00464334|E9|Reported Event|V950 5 mcg / IMX 47 mcg|Participants receive V950 5 mcg/IMX 47 mcg
459011|NCT00464334|E8|Reported Event|V950 5 mcg / IMX 16 mcg|Participants receive V950 5 mcg/IMX 16 mcg
459012|NCT00464334|E7|Reported Event|V950 5 mcg / IMX 0 mcg|Participants receive V950 5 mcg/IMX 0 mcg
459013|NCT00464334|E6|Reported Event|V950 0.5 mcg / IMX 94 mcg|Participants receive V950 0.5 mcg/IMX 94 mcg
459014|NCT00464334|E5|Reported Event|V950 0.5 mcg / IMX 47 mcg|Participants receive V950 0.5 mcg/IMX 47 mcg
459015|NCT00464334|E4|Reported Event|V950 0.5 mcg / IMX 16 mcg|Participants receive V950 0.5 mcg/IMX 16 mcg
459016|NCT00464334|E3|Reported Event|V950 0.5 mcg / IMX 0 mcg|Participants receive V950 0.5 mcg/IMX 0 mcg
459017|NCT00464334|E2|Reported Event|Placebo to V950/ IMX 16 mcg|Participants receive Placebo to V950/IMX 16 mcg
459018|NCT00464334|E1|Reported Event|Placebo to V950/ IMX 0 mcg|Participants receive Placebo to V950/IMX 0 mcg
459019|NCT00464308|B4|Baseline|Total|Total of all reporting groups
459020|NCT00464308|B3|Baseline|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459021|NCT00464308|B2|Baseline|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459022|NCT00464308|B1|Baseline|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459023|NCT00464308|P3|Participant Flow|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459024|NCT00464308|P2|Participant Flow|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459025|NCT00464308|P1|Participant Flow|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459026|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459027|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459028|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459029|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459030|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459031|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459032|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459033|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459034|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459035|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459036|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459037|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459038|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459039|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459040|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459041|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459042|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459043|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459044|NCT00464308|O3|Outcome|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459045|NCT00464308|O2|Outcome|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459046|NCT00464308|O1|Outcome|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459047|NCT00464308|E3|Reported Event|Esomeprazole 20 mg/Day|Esomeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459048|NCT00464308|E2|Reported Event|Esomeprazole 40 mg/Day|Esomeprazole 40 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459049|NCT00464308|E1|Reported Event|Rabeprazole 20 mg/Day|Rabeprazole 20 mg once daily for 28 days - 1 placebo tablet/capsule plus 1 active tablet/capsule daily
459050|NCT00464269|B5|Baseline|Total Title|
459051|NCT00464269|B4|Baseline|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
459052|NCT00464269|B3|Baseline|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
459053|NCT00464269|B2|Baseline|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
459054|NCT00464269|B1|Baseline|Placebo|Matching Placebo tablets administered twice a day
459055|NCT00464269|P4|Participant Flow|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
459056|NCT00464269|P3|Participant Flow|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
459057|NCT00464269|P2|Participant Flow|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
459058|NCT00464269|P1|Participant Flow|Placebo|Matching Placebo tablets administered twice a day
459059|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459060|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459061|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459062|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459063|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459064|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459065|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459066|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459067|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459068|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459069|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459182|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459070|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459071|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459072|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459073|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459074|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459075|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459076|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459077|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459078|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459079|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459080|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459081|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459082|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459083|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459084|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459183|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459085|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459086|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459087|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459088|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459089|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459090|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459091|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459092|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459093|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459094|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459095|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459096|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459097|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459098|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459099|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459184|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459100|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459101|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459102|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459103|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459104|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459105|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459106|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459107|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459108|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459109|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459110|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459111|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459112|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459113|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459114|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459185|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459115|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459116|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459117|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459118|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459119|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459120|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459121|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459122|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459123|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459124|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459125|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459126|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459127|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459128|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459129|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459186|NCT00464204|E2|Reported Event|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459130|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459131|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459132|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459133|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459134|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459135|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459136|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459137|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459138|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459139|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459140|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459141|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459142|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459143|NCT00464269|O4|Outcome|Modified Intention-to-Treat (BRV 50 mg/Day Treated Subjects)|"Brivaracetam 50 mg/day, 25 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459144|NCT00464269|O3|Outcome|Modified Intention-to-Treat (BRV 20 mg/Day Treated Subjects)|"Brivaracetam 20 mg/day, 10 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459187|NCT00464204|E1|Reported Event|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459145|NCT00464269|O2|Outcome|Modified Intention-to-Treat (BRV 5 mg/Day Treated Subjects)|"Brivaracetam 5 mg/day, 2.5 mg administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459146|NCT00464269|O1|Outcome|Modified Intention-to-Treat (Placebo Treated Subjects)|"Matching Placebo tablets administered twice a day.~The modified Intent-To-Treat population consists of subjects who received at least one dose of study medication but excluding 3 randomized subjects from a site with significant GCP deviations and 1 subject who had an exceedingly high seizure frequency and a clinical presentation that may not have been consistent with a diagnosis of focal epilepsy."
459147|NCT00464269|E4|Reported Event|BRV 50 mg/Day|Brivaracetam 50 mg/day, 25 mg administered twice a day
459148|NCT00464269|E3|Reported Event|BRV 20 mg/Day|Brivaracetam 20 mg/day, 10 mg administered twice a day
459149|NCT00464269|E2|Reported Event|BRV 5 mg/Day|Brivaracetam 5 mg/day, 2.5 mg administered twice a day
459150|NCT00464269|E1|Reported Event|Placebo|Matching Placebo tablets administered twice a day
459151|NCT00464204|B3|Baseline|Total|Total of all reporting groups
459152|NCT00464204|B2|Baseline|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459153|NCT00464204|B1|Baseline|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459154|NCT00464204|P2|Participant Flow|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459155|NCT00464204|P1|Participant Flow|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459156|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459157|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459158|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459159|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459160|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459161|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459162|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 % NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459163|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4 Voluven® rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day.
459164|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459165|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459166|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459167|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459168|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459169|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459170|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459171|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459172|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459173|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459174|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459175|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459176|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459177|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459178|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459179|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459180|NCT00464204|O2|Outcome|NaCl 0.9 % Arm|NaCl 0.9 %; NaCl 0.9 % rates were not to exceed 50 mL/kg/day on the first day and 25 mL/kg/day from the second to the fourth day
459181|NCT00464204|O1|Outcome|Voluven® Arm|6 % Hydroxyethylstarch 130/0.4; Voluven® rates were not to exceed 50 mL/kg/day on the first days and 25 mL/kg/day from the second to the fourth day
459189|NCT00464087|B3|Baseline|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
459190|NCT00464087|B2|Baseline|Bivalirudin|bivalirudin during angioplasty
459191|NCT00464087|B1|Baseline|Heparin|unfrationated heparin during angioplasty
459192|NCT00464087|P3|Participant Flow|Screen Failures|These patients were enrolled because they received study drug, but did not have enough disease to require PCI.
459193|NCT00464087|P2|Participant Flow|Bivalirudin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to Bivalirudin during angioplasty and receive a minimum dose of bolus 0.75 mg/kg IV followed by, infusion of 1.75 mg/kg/hr for the duration of the PCI.
459194|NCT00464087|P1|Participant Flow|Heparin|All patients received fondaparinux at a dose of 2.5 mg subcutaneously no more than 24 hours before angioplasty. They are randomized to unfractionated heparin during angioplasty and receive a minimum dose of 60 U/kg IV.
459195|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
459196|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
459197|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
459198|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
459199|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
459200|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
459201|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
459202|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
459203|NCT00464087|O3|Outcome|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
459204|NCT00464087|O2|Outcome|Bivalirudin|bivalirudin during angioplasty
459205|NCT00464087|O1|Outcome|Heparin|unfractionated heparin during angioplasty
459206|NCT00464087|E3|Reported Event|Screen Failures|Screen Failures are patients who are enrolled and receive the study drug, but do not have enough disease to have percutaneous coronary intervention.
459207|NCT00464087|E2|Reported Event|Bivalirudin|bivalirudin during angioplasty
459208|NCT00464087|E1|Reported Event|Heparin|unfrationated heparin during angioplasty
459209|NCT00463866|B3|Baseline|Total|Total of all reporting groups
459210|NCT00463866|B2|Baseline|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459211|NCT00463866|B1|Baseline|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459212|NCT00463866|P2|Participant Flow|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459213|NCT00463866|P1|Participant Flow|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459214|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459215|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459216|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459217|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459218|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459219|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459220|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459221|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459222|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459223|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459224|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459225|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459226|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459227|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459228|NCT00463866|O2|Outcome|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459229|NCT00463866|O1|Outcome|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459230|NCT00463866|E2|Reported Event|Symbicort® SMART®) 2*2|2 inhalations of Symbicort 160µg/4.5µg twice daily plus as-needed.
459231|NCT00463866|E1|Reported Event|Symbicort® SMART®) 1*2|1 inhalation of Symbicort 160µg/4.5µg twice daily plus as-needed.
459232|NCT00463840|B1|Baseline|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
459251|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459295|NCT00463580|E2|Reported Event|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
459750|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459233|NCT00463840|P1|Participant Flow|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
459234|NCT00463840|O1|Outcome|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
459235|NCT00463840|E1|Reported Event|Oxaliplatin+ 5FU+ Radiation (RT) /Surgery /FOLFOX 6|"Concurrent chemoradiation before surgery and FOLFOX6 regimen after surgery:~Radiation (RT) 180cGy daily x 5 days/week x 5 weeks, then additional 540 cGy in 3 fractions over a half week to pancreatic portal;~Combined with :~5FU 200 mg/m^2 daily by continuous intravenous infusion (CIV) x 5 weeks and weekly Oxaliplatin 60 mg/m^2, IV for 5 weeks (in Phase I, 30, 40, 50, and 60 mg/m^2 Oxaliplatin were tested).~Observation for 2 weeks to assess dose-limiting toxicity (DLT)/Response. Surgery if deemed resectable.~Then modified FOLFOX 6 for 6 cycles (2 weeks/cycle):~Day 1 hour 0: Oxaliplatin 85 mg/m^2 intravenously (IV) + Leucovorin 350 mg IV over 2 hours; hour 2: 5FU 400 mg/m^2 IV bolus followed by 2400 mg/m^2 IV over 46 hours."
459236|NCT00463801|B1|Baseline|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
459237|NCT00463801|P1|Participant Flow|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
459238|NCT00463801|O1|Outcome|Daptomycin Intravenous|350 mg of Daptomycin was supplied as sterile lyophilized powder in glass vials. Each vial was to be reconstituted with 7 mL of normal saline or water for injection, to give a 50 mg/mL drug concentration. Daptomycin was to be administered as a 30-minute intravenous infusion, once daily for at least 7 days, at the dose of 4 mg/Kg, up to a maximum of 14 days.
459239|NCT00463801|E1|Reported Event|All Patients|All patients
459240|NCT00463788|B3|Baseline|Total|Total of all reporting groups
459241|NCT00463788|B2|Baseline|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459242|NCT00463788|B1|Baseline|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459243|NCT00463788|P2|Participant Flow|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459244|NCT00463788|P1|Participant Flow|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459245|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459246|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459247|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459248|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459249|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459250|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459293|NCT00463580|O2|Outcome|Placebo|Normal Saline
459294|NCT00463580|O1|Outcome|Infliximab|Infliximab
459252|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459253|NCT00463788|O2|Outcome|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of PD, unacceptable toxicity or withdrawal of consent.
459254|NCT00463788|O1|Outcome|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly. Participants who demonstrated at least stable disease (SD) up to 6 cycles of cisplatin continued treatment with cetuximab only until progressive disease (PD) or occurrence of unacceptable toxicity.
459255|NCT00463788|E3|Reported Event|Cisplatin Alone Switched to Cetuximab|On progression, participants in the cisplatin group had the option to switch to cisplatin (75 mg/m^2 IV infusion) plus cetuximab (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progressive disease was reported during the 6 cisplatin cycles or to cetuximab alone (initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion) if the progression was reported after the 6 cisplatin cycles.
459256|NCT00463788|E2|Reported Event|Cisplatin|Cisplatin 75 mg/m^2 IV infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles until the first occurrence of progressive disease (PD), unacceptable toxicity or withdrawal of consent.
459257|NCT00463788|E1|Reported Event|Cisplatin and Cetuximab|Cisplatin 75 milligram per square meter (mg/m^2) intravenous (IV) infusion administered on Day 1 until every 3 weeks with a maximum of 6 cycles and cetuximab initially 400 mg/m^2 followed by 250 mg/m^2 IV infusion weekly.
459258|NCT00463606|B4|Baseline|Total|Total of all reporting groups
459259|NCT00463606|B3|Baseline|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459260|NCT00463606|B2|Baseline|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
459261|NCT00463606|B1|Baseline|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459262|NCT00463606|P3|Participant Flow|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459263|NCT00463606|P2|Participant Flow|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
459264|NCT00463606|P1|Participant Flow|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459265|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459266|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459267|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459268|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459269|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459270|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459271|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459272|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459273|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459274|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459275|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
459276|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459277|NCT00463606|O2|Outcome|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
459278|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459279|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459280|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459281|NCT00463606|O2|Outcome|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459282|NCT00463606|O1|Outcome|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459283|NCT00463606|E3|Reported Event|Rosuvastatin Calcium|Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks
459284|NCT00463606|E2|Reported Event|ABT-335|ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks
459285|NCT00463606|E1|Reported Event|ABT-335 and Rosuvastatin Calcium|ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks
459286|NCT00463580|B3|Baseline|Total|Total of all reporting groups
459287|NCT00463580|B2|Baseline|Placebo|
459288|NCT00463580|B1|Baseline|Infliximab|Infliximab
459289|NCT00463580|P2|Participant Flow|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
459290|NCT00463580|P1|Participant Flow|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
459291|NCT00463580|O2|Outcome|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
459292|NCT00463580|O1|Outcome|Infliximab|Participants in this arm receive Infliximab(5mg/kg)at Baseline and at weeks 2 and 6 of a 12-week trial.
459296|NCT00463580|E1|Reported Event|Placebo|Participants in this arm receive normal saline at Baseline and at weeks 2 and 6 of a 12- week trial.
459297|NCT00463567|B8|Baseline|Total|Total of all reporting groups
459298|NCT00463567|B7|Baseline|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459299|NCT00463567|B6|Baseline|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459300|NCT00463567|B5|Baseline|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459301|NCT00463567|B4|Baseline|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459302|NCT00463567|B3|Baseline|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459303|NCT00463567|B2|Baseline|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459304|NCT00463567|B1|Baseline|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459305|NCT00463567|P7|Participant Flow|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459306|NCT00463567|P6|Participant Flow|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459307|NCT00463567|P5|Participant Flow|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459308|NCT00463567|P4|Participant Flow|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459309|NCT00463567|P3|Participant Flow|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459310|NCT00463567|P2|Participant Flow|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459344|NCT00463437|B2|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459751|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459752|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459311|NCT00463567|P1|Participant Flow|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459312|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459313|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459314|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459315|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459316|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459317|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459318|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459319|NCT00463567|O7|Outcome|Formoterol 12 µg|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459320|NCT00463567|O6|Outcome|Indacaterol 600 µg|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459321|NCT00463567|O5|Outcome|Indacaterol 75 µg|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459322|NCT00463567|O4|Outcome|Placebo|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459323|NCT00463567|O3|Outcome|Tiotropium 18 µg|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®).~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459324|NCT00463567|O2|Outcome|Indacaterol 300 µg|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459325|NCT00463567|O1|Outcome|Indacaterol 150 µg|"In the morning, Indacaterol 150 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459326|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459327|NCT00463567|O3|Outcome|Tiotropium (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459328|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459329|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459330|NCT00463567|O4|Outcome|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459331|NCT00463567|O3|Outcome|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459332|NCT00463567|O2|Outcome|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459333|NCT00463567|O1|Outcome|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459334|NCT00463567|E7|Reported Event|Formoterol 12 µg (Not Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Formoterol 12 µg delivered via Aerolizer. In evening, Formoterol 12 µg delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459335|NCT00463567|E6|Reported Event|Indacaterol 600 µg (Not Continued Into Stage 2)|"In the morning, 2 capsules of Indacaterol 300 µg once daily orally inhaled via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459336|NCT00463567|E5|Reported Event|Indacaterol 75 µg (Not Continued Into Stage 2)|"In the morning, Indacaterol 75 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 but did not continue to Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459337|NCT00463567|E4|Reported Event|Placebo (Continued Into Stage 2)|"In the morning, Placebo to Indacaterol delivered via two SDDPI devices + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459338|NCT00463567|E3|Reported Event|Tiotropium 18 µg (Continued Into Stage 2)|"Tiotropium 18 µg dry powder capsules delivered (open label) via manufacturer's proprietary SDDPI, (Handihaler®). Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459339|NCT00463567|E2|Reported Event|Indacaterol 300 µg (Continued Into Stage 2)|"In the morning, Indacaterol 300 µg once daily orally inhaled via a SDDPI + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily ICS monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459340|NCT00463567|E1|Reported Event|Indacaterol 150 µg (Continued Into Stage 2)|"In the morning, Indacaterol 150 µg once daily orally inhaled via a single dose dry powder inhaler (SDDPI) + Placebo to Indacaterol delivered via SDDPI + Placebo to Formoterol delivered via Aerolizer. In the evening, Placebo to Formoterol delivered via Aerolizer. Participated in the 2 week Stage 1 and continued treatment up to 26 weeks in Stage 2. Placebo to Formoterol inhalation in the morning and in the evening was discontinued after Stage 1.~Daily Inhaled Corticosteroid (ICS) monotherapy (if applicable) was to remain stable and Salbutamol/albuterol was available for rescue use throughout study."
459341|NCT00463437|B5|Baseline|Total|Total of all reporting groups
459342|NCT00463437|B4|Baseline|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459343|NCT00463437|B3|Baseline|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459753|NCT00462709|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459345|NCT00463437|B1|Baseline|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459346|NCT00463437|P4|Participant Flow|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459347|NCT00463437|P3|Participant Flow|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459348|NCT00463437|P2|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459349|NCT00463437|P1|Participant Flow|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459350|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459351|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459352|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459353|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459354|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459355|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459356|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459357|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459358|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459359|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459360|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459361|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459362|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459363|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459364|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459365|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459366|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459367|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459368|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459369|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459370|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459371|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459372|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459373|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459374|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459375|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459376|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459377|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459378|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459379|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459380|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459381|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459382|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459383|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459384|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459385|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459386|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459387|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459388|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459389|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459390|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459391|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459392|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459393|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459394|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459395|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459396|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459397|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459398|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459399|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459400|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459401|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459402|NCT00463437|O4|Outcome|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459403|NCT00463437|O3|Outcome|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459404|NCT00463437|O2|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459405|NCT00463437|O1|Outcome|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459406|NCT00463437|E4|Reported Event|Prevenar™ + Menitorix™|Subjects receiving a booster dose of Wyeth’s pneumococcal conjugate vaccine (Prevenar™) co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459407|NCT00463437|E3|Reported Event|GSK’s 10-valent Pneumococcal Vaccine 1024850A + Menitorix™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with DTPa-combined vaccine (Infanrix™ penta in Germany & Poland and Infanrix™ IPV in Spain) and GSK Biologicals’ combined Hib-MenC vaccine (Menitorix™) at 11-18 months of age.
459408|NCT00463437|E2|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + NeisVac-C™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Baxter’s Men-C conjugate vaccine (NeisVac-C™) at 11-18 months of age.
459409|NCT00463437|E1|Reported Event|GSK's 10-valent Pneumococcal Vaccine 1024850A + Meningitec™|Subjects receiving a booster dose of pneumococcal conjugate vaccine GSK1024850A co-administered with GSK Biologicals’ DTPa-combined vaccine (Infanrix™ hexa in Germany & Poland and Infanrix™ IPV Hib in Spain) and Wyeth’s Men-C conjugate vaccine (Meningitec™) at 11-18 months of age.
459410|NCT00463385|B5|Baseline|Total|Total of all reporting groups
459411|NCT00463385|B4|Baseline|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459412|NCT00463385|B3|Baseline|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459413|NCT00463385|B2|Baseline|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459414|NCT00463385|B1|Baseline|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459415|NCT00463385|P4|Participant Flow|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459416|NCT00463385|P3|Participant Flow|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459417|NCT00463385|P2|Participant Flow|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459418|NCT00463385|P1|Participant Flow|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459419|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459754|NCT00462670|B3|Baseline|Total|Total of all reporting groups
459755|NCT00462670|B2|Baseline|OPC-41061|15mg of OPC-41061 per day for 7days p.o. administration
459420|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459421|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459422|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459423|NCT00463385|O8|Outcome|Pomalidomide 0.5 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459424|NCT00463385|O7|Outcome|Pomalidomide 2 mg + Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459425|NCT00463385|O6|Outcome|Pomalidomide 2 mg, Negative JAK2|"Participants with a negative JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459426|NCT00463385|O5|Outcome|Prednisone, Negative JAK2|"Participants with a negative JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459427|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459428|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459429|NCT00463385|O2|Outcome|Pomalidomide 2 mg, PositiveJAK2|"Participants with a positive JAK2 result at Baseline received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459430|NCT00463385|O1|Outcome|Prednisone, Positive JAK2|"Participants with a positive JAK2 result at Baseline received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459431|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459756|NCT00462670|B1|Baseline|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
459757|NCT00462670|P2|Participant Flow|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459432|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459433|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459434|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459435|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459436|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459437|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459438|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459439|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459440|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459441|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459442|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459443|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459444|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459445|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459446|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459447|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459448|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459449|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459450|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459451|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459452|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459453|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459454|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459455|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459456|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459457|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
460199|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
459458|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459459|NCT00463385|O4|Outcome|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459460|NCT00463385|O3|Outcome|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459461|NCT00463385|O2|Outcome|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459462|NCT00463385|O1|Outcome|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459463|NCT00463385|E4|Reported Event|Pomalidomide 0.5 mg + Prednisone|"Participants received 0.5 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 0.5 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459464|NCT00463385|E3|Reported Event|Pomalidomide 2 mg + Prednisone|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and oral prednisone tablets on Days 1-28 for the first 3 cycles, 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459465|NCT00463385|E2|Reported Event|Pomalidomide 2 mg|"Participants received 2 mg oral pomalidomide daily from Day 1-28 of each 28-day cycle for up to 12 cycles (336 days), and prednisone placebo tablets on Days 1-28 for the first 3 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, eligible participants continued to receive oral pomalidomide 2 mg daily, from Days 1-28 of each cycle. Participants could remain on study treatment in the Extension Phase until disease progression, unacceptable toxicity or voluntary withdrawal."
459466|NCT00463385|E1|Reported Event|Prednisone|"Participants received oral prednisone from Day 1-28 of each 28-day cycle for up to 3 cycles (84 days), 1st cycle = 30 mg daily, 2nd cycle = 15 mg daily, 3rd cycle = 15 mg every other day, and pomalidomide placebo tablets on Days 1-28 for up to 12 cycles in the Double-Blind Treatment Phase.~After the completion of cycle 12 and upon unblinding, participants were discontinued from the study."
459467|NCT00463346|B3|Baseline|Total|Total of all reporting groups
459468|NCT00463346|B2|Baseline|Placebo|Placebo dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459469|NCT00463346|B1|Baseline|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459470|NCT00463346|P2|Participant Flow|Placebo|dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459471|NCT00463346|P1|Participant Flow|Acamprosate|Acamprosate 1998 mg TID dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459472|NCT00463346|O2|Outcome|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459473|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~Acamprosate: Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
459474|NCT00463346|O2|Outcome|Placebo|Placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459475|NCT00463346|O1|Outcome|Acamprosate|"Acamprosate~1998 mg TID Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules."
459476|NCT00463346|E2|Reported Event|Placebo|placebo Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459477|NCT00463346|E1|Reported Event|Acamprosate|Acamprosate 1998 mg tid. Study medication was dispensed weekly in blister packs, labeled with the date and time, in identical looking capsules.
459478|NCT00463229|B3|Baseline|Total|Total of all reporting groups
459479|NCT00463229|B2|Baseline|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
459480|NCT00463229|B1|Baseline|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
459481|NCT00463229|P2|Participant Flow|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
459482|NCT00463229|P1|Participant Flow|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
459483|NCT00463229|O2|Outcome|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
459484|NCT00463229|O1|Outcome|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
459485|NCT00463229|E2|Reported Event|Usual Home Care Services|Participants allocated to the control group received standard home care services arranged by the CCAC. These include routine follow-up by the CCAC case manager whose focus is on assessment and referral to community agencies, and ongoing monitoring and evaluating the plan of care through in-home assessment with clients.
459486|NCT00463229|E1|Reported Event|Interprofessional Team Approach|Participants in the experimental group will receive home care services from a team of professional service providers (CCAC Care Coordinator, Registered Nurse, Occupational therapist, Physiotherapist, Speech language pathologist, Nutritionist) and non-professional service providers (personal support workers) with experience and training in stroke care. The team will provide a comprehensive, coordinated and evidence-based approach to stroke rehabilitation through weekly case conferencing, a written interdisciplinary care plan, and joint visits.
459487|NCT00463047|B1|Baseline|Total Number of Patients|Fentanyl Buccal Tablets (FBT) and Immediate-Release Oxycodone crossover. The total number of patients (323) reflect the number that were enrolled to participate in the study prior to the first titration period. Three subjects withdrew before receiving any study drug so they are not listed as being assigned to either dosing arm in the titration studies, leaving only 320 subjects who were evenly divided between the two groups.
459488|NCT00463047|P2|Participant Flow|Immediate-Release Oxycodone First FBT Second|Patients were randomly assigned 1:1 to either titrate FBT during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
459489|NCT00463047|P1|Participant Flow|FBT First Immediate Release Oxycodone Second|Patients were randomized 1:1 to titrate Fentanyl Buccal Tablet (FBT) during the first titration period and then titrated immediate-release oxycodone during the second period or the reverse. Titration began with either 200 mcg FBT or 15 mg oxycodone taken as needed for breakthrough pain. If after 30 minutes pain relief was unsuccessful, a second dose could be taken. If more than one dose was required for at least 1 of 3 breakthrough pain episodes in one day, the next day the dose was increased in 200 mcg increments for FBT and 15 mg increments for oxycodone. The maximum allowable dose was 800 mcg for FBT (4 tablets) and 60 mg (4 capsules) for oxycodone. If a dose was not tolerated the dose was lowered to the previous tolerated dose. Titration completed when successful analgesia was achieved with a tolerated dose or maximum dose was reached. If unsuccessful at maximum dose subject was discontinued from proceeding further in the study. Subjects who successfully titrated were randomized.
459490|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459491|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459492|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459493|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
460751|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
459494|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459495|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459496|NCT00463047|O1|Outcome|Total|Includes all patients who participated in the double-blind treatment period and completed treatment.
459497|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459498|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459499|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459500|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459501|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459502|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459503|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459504|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459505|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459506|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459507|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459508|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459509|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459510|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459511|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459512|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459513|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459514|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459515|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459516|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459517|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459518|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459519|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459520|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459521|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459522|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459523|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459524|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459525|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459526|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459527|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459528|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459529|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459530|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459531|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459532|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459533|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459534|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459535|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459536|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459537|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459538|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459758|NCT00462670|P1|Participant Flow|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459539|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459540|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459541|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459542|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459543|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459544|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459545|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459546|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459547|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459548|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459549|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459550|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459551|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459552|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459553|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459554|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459555|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459556|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459557|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459558|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459559|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459560|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459759|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459561|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459562|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459563|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459564|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459565|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459566|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459567|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459568|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459569|NCT00463047|O2|Outcome|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug.
459570|NCT00463047|O1|Outcome|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients.
459571|NCT00463047|E2|Reported Event|Immediate-Release Oxycodone|Immediate-release oxycodone (or matching placebo) at doses of 15,30, 45, and 60 mg was self administered. The double-blind, treatment period used a 2 period crossover design in which the patient first managed 10 episodes with 1 of the 2 blinded study drugs (successful doses of immediate-release oxycodone or FBT) and then managed a subsequent 10 episodes with the other blinded study drug. This arm represents all subjects who had exposure to at least one dose of immediate-release oxycodone either during the titration periods or double-blind periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
459572|NCT00463047|E1|Reported Event|Fentanyl Buccal Tablets (FBT)|FBT or matching placebo during the 2 double-blind treatment periods at doses of 200, 400, 600, and 800 mcg was self-administered by patients. This group includes all subjects in this study who had taken at least one dose of FBT in the course of the study, including both titration periods and both double-blind treatment periods. 320 subjects were randomized to titrate either FBT or oxycodone. 39 subjects received only oxycodone before discontinuing leaving 281 who received FBT during the study. 36 subjects received only FBT before discontinuing, leaving only 284 who received oxycodone.
459573|NCT00462982|B1|Baseline|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
459574|NCT00462982|P1|Participant Flow|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
459575|NCT00462982|O1|Outcome|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
459576|NCT00462982|E1|Reported Event|Sunitinib|Patients will be treated with 50 mg daily for four out of every six weeks.
459577|NCT00462943|B4|Baseline|Total|Total of all reporting groups
459578|NCT00462943|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459579|NCT00462943|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459580|NCT00462943|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459609|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459581|NCT00462943|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459582|NCT00462943|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459583|NCT00462943|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459584|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459585|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459586|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459587|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459588|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459589|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459590|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459591|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459592|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459593|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459594|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
461414|NCT00457821|B6|Baseline|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
459595|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459596|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459597|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459598|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459599|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459600|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459601|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459602|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459603|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459604|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459605|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459606|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459607|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459608|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459760|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459610|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459611|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459612|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459613|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459614|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459615|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459616|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459617|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459618|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459619|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459620|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459621|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459622|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459623|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459950|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459624|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459625|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459626|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459627|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459628|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459629|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459630|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459631|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459632|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459633|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459634|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459635|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459636|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459637|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459687|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459638|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459639|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459640|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459641|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459642|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459643|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459644|NCT00462943|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459645|NCT00462943|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459646|NCT00462943|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459647|NCT00462943|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459648|NCT00462943|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
459649|NCT00462917|B5|Baseline|Total|Total of all reporting groups
459650|NCT00462917|B4|Baseline|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459651|NCT00462917|B3|Baseline|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459652|NCT00462917|B2|Baseline|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459688|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459653|NCT00462917|B1|Baseline|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459654|NCT00462917|P4|Participant Flow|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459655|NCT00462917|P3|Participant Flow|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459656|NCT00462917|P2|Participant Flow|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459657|NCT00462917|P1|Participant Flow|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459658|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459659|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459660|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459661|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459662|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459663|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459664|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459665|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459666|NCT00462917|O4|Outcome|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459667|NCT00462917|O3|Outcome|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459668|NCT00462917|O2|Outcome|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459669|NCT00462917|O1|Outcome|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459670|NCT00462917|E4|Reported Event|AD-only Info, In-person Disclosure|"Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment~AD-only info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459671|NCT00462917|E3|Reported Event|Pleiotropic Info, Phone Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment~Pleiotropic info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during a telephone disclosure session."
459672|NCT00462917|E2|Reported Event|AD-only Info, Phone Disclosure|"Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment~AD-only info, phone disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping.~Genetic counselors communicate results to participants during an in-person disclosure session."
459673|NCT00462917|E1|Reported Event|Pleiotropic Info, In-person Disclosure|"Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment~Pleiotropic info, in-person disclosure: Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information.~Genetic counselors communicate results to participants during an in-person disclosure session."
459674|NCT00462865|B1|Baseline|Treatment|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
459675|NCT00462865|P1|Participant Flow|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
459676|NCT00462865|O1|Outcome|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles that lead to patients being taken off study.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
459677|NCT00462865|E1|Reported Event|Gemcitabine, Capectiabine, Avastin|"After completion of neoadjuvant as well as surgical therapy the combination of gemcitabine/ Capecitabine and Avastin will be given for a total of six cycles.~Doses to be administered:~Gemcitabine 2000 mg/m2 on D1 Capecitabine 650 mg/m2 BID on D1-14 Avastin 15 mg/kg on D1~Following six cycles, patients will proceed to comprehensive breast radiation (if indicated) and will continue to receive avastin every 3 weeks during and after radiotherapy to complete 1 year of treatment."
459678|NCT00462839|B3|Baseline|Total|Total of all reporting groups
459679|NCT00462839|B2|Baseline|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459680|NCT00462839|B1|Baseline|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459681|NCT00462839|P2|Participant Flow|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459682|NCT00462839|P1|Participant Flow|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459683|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459684|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459685|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459686|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459689|NCT00462839|O2|Outcome|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459690|NCT00462839|O1|Outcome|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459691|NCT00462839|E2|Reported Event|Noncalibrated Drapes Viewed First|No distinguishable volume markings on drape (standard of care). Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459692|NCT00462839|E1|Reported Event|Calibrated Vaginal Delivery Drapes Viewed First|Calibrated drapes had volume markings beginning at 500ml with 500ml increments to a total of 2500ml. Subjects were randomized to either view calibrated or uncalibrated (standard of care) drapes and asking to estimated volume of blood loss. Subjects were then crossed over and experiment repeated.
459693|NCT00462826|B1|Baseline|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459694|NCT00462826|P1|Participant Flow|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459695|NCT00462826|O1|Outcome|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459696|NCT00462826|E1|Reported Event|Treatment (Aflibercept)|Patients receive VEGF Trap IV over 1 hour on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
459697|NCT00462748|B4|Baseline|Total|Total of all reporting groups
459698|NCT00462748|B3|Baseline|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
459699|NCT00462748|B2|Baseline|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
459700|NCT00462748|B1|Baseline|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
459701|NCT00462748|P3|Participant Flow|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
459702|NCT00462748|P2|Participant Flow|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
459703|NCT00462748|P1|Participant Flow|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
459704|NCT00462748|O3|Outcome|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
459705|NCT00462748|O2|Outcome|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
459706|NCT00462748|O1|Outcome|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
459707|NCT00462748|E3|Reported Event|Rosuvastatin|rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally
459708|NCT00462748|E2|Reported Event|Atorvostatin|atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally
459709|NCT00462748|E1|Reported Event|Ezetimibe/Simvastatin|ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally
459710|NCT00462722|B4|Baseline|Total|Total of all reporting groups
459711|NCT00462722|B3|Baseline|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459712|NCT00462722|B2|Baseline|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459713|NCT00462722|B1|Baseline|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459714|NCT00462722|P3|Participant Flow|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459715|NCT00462722|P2|Participant Flow|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459716|NCT00462722|P1|Participant Flow|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459748|NCT00462709|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV) every 3 to 7 days.
459717|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459718|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459719|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459720|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459721|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459722|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459723|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459724|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459725|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459726|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459727|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459728|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459729|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459730|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459731|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459749|NCT00462709|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459732|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459733|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459734|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459735|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459736|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459737|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459738|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459739|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459740|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459741|NCT00462722|O3|Outcome|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459742|NCT00462722|O2|Outcome|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459743|NCT00462722|O1|Outcome|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459744|NCT00462722|E3|Reported Event|Placebo Pre and Ibuprofen Post Exercise|"placebo before and ibuprofen after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459745|NCT00462722|E2|Reported Event|Ibuprofen Pre and Placebo Post Exercise|"ibuprofen before and placebo after musculoskeletal-loading exercise~Ibuprofen: 400 mg with each exercise session (up to 5 days per week) for 9 months~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459746|NCT00462722|E1|Reported Event|Placebo Pre and Post Exercise|"placebo before and after musculoskeletal-loading exercise~Placebo: with each exercise session (up to 5 days per week) for 9 months~musculoskeletal-loading exercise: Exercise training program designed to increase bone and muscle mass, including weight lifting and weight-bearing exercises such as jumping in place and treadmill walking up to 5 days per week for 9 months"
459747|NCT00462709|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV every 3 to 7 days.
459761|NCT00462670|O2|Outcome|OPC-41061 15mg|"15mg OPC-41061~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459762|NCT00462670|O1|Outcome|Placebo|"0mg~OPC-41061(Tolvaptan) : 0, 15mg of OPC-41061 per day for 7days p.o. administration"
459763|NCT00462670|E2|Reported Event|OPC-41061 15mg|15 mg of OPC-41061 per day for 7days p.o. administration
459764|NCT00462670|E1|Reported Event|Placebo|0 mg of OPC-41061 per day for 7days p.o. administration
459765|NCT00462644|B3|Baseline|Total|Total of all reporting groups
459766|NCT00462644|B2|Baseline|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459767|NCT00462644|B1|Baseline|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459768|NCT00462644|P2|Participant Flow|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459769|NCT00462644|P1|Participant Flow|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459770|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459771|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459772|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459773|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459774|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459775|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459776|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459777|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459778|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459779|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459780|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459781|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459782|NCT00462644|O2|Outcome|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459783|NCT00462644|O1|Outcome|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459784|NCT00462644|E2|Reported Event|Fentanyl-Midazolam|Fentanyl-Midazolam Group patients were randomized to receive 100ug fentanyl IV, plus 5 mg midazolam IV, plus 1mg/kg succinylcholine IV for RSI medications.
459785|NCT00462644|E1|Reported Event|Etomidate|Etomidate Group patients were randomized to receive etomidate 0.3mg/kg IV plus succinylcholine 1mg/kg IV for RSI medications
459786|NCT00462501|B1|Baseline|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
459787|NCT00462501|P1|Participant Flow|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
459818|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
459819|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
459820|NCT00462423|E1|Reported Event|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
459788|NCT00462501|O1|Outcome|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
459789|NCT00462501|E1|Reported Event|Chemotherapy and Bevacizumab With or Without Radiation|FOLFOX/Bevacizumab will be given for 4 cycles over 8 weeks; FOLFOLX6 without Bevacizumab will be given for an additional 2 cycles over 4 weeks. Oxaliplatin will be given on Day 1 of each cycle over 2 hours at 85 mg/m2 IV. Leucovorin will be given Day 1 of each cycle over 2 hours at 400 mg/m2 IV. Fluorouracil will be given on Day 1 of each cycle at 400 mg/m2 IVP, then Fluorouracil will be given at 1200 mg/m2 IVCI over Day 1 and 2. Bevacizumab will be given at 5mg/kg over 10 minutes on day 1. Patients will undergo re-staging within 3 weeks of completing their 6th cycle of FOLFOX. If the reassessment reveals that there has been no disease progression as compared to the pre-treatment evaluation and the patient remains a candidate for an R0 resection. If the surgical oncologist’s reassessment is that the patient is not a candidate for an R0 resection, the patient will proceed to standard pre-operative radiation with synchronous infusional 5-fluorouracil.
459790|NCT00462462|B3|Baseline|Total|Total of all reporting groups
459791|NCT00462462|B2|Baseline|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
459792|NCT00462462|B1|Baseline|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
459793|NCT00462462|P2|Participant Flow|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
459794|NCT00462462|P1|Participant Flow|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
459795|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and for whom lesional volume measurements were available at screening and at study end
459796|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and for whom lesional volume measurements were available at screening and at study end
459797|NCT00462462|O2|Outcome|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol and who had blood samples just before and during infusion procedure (one patient who received Absolute Ethanol was not sampled during infusion procedure).
459798|NCT00462462|O1|Outcome|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel and who had blood samples just before and during infusion procedure.
459799|NCT00462462|E2|Reported Event|Absolute Ethanol Group|Patients who received one intralesional administration of Absolute Ethanol
459800|NCT00462462|E1|Reported Event|L0122 Gel Group|Patients who received one intralesional administration of L0122 gel
459801|NCT00462449|B3|Baseline|Total|Total of all reporting groups
459802|NCT00462449|B2|Baseline|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
459803|NCT00462449|B1|Baseline|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
459804|NCT00462449|P2|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
459805|NCT00462449|P1|Participant Flow|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
459806|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
459807|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
459808|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
459809|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
459810|NCT00462449|O2|Outcome|Repetitive Task Practice Alone|Individuals randomized to receive Repetitive Task Practice alone.
459811|NCT00462449|O1|Outcome|FES and Repetitive Task Practice (RTP)|Individuals who were randomized to receive Functional Electrical Stimulation together with Repetitive Task Practice
459812|NCT00462449|E2|Reported Event|Chedoke-McMaster Assessment Hand Impairment 4-6 RTP + FES|In addition to appropriate therapy, this group will receive the FES device and be given instruction on how to complete specialized exercises utilizing this device.
459813|NCT00462449|E1|Reported Event|Chedoke-McMaster Assessment Hand Impairment 2, 3 - RTP Alone|Individuals randomized into this group will only receive specialized therapy associated with this population.
459814|NCT00462423|B1|Baseline|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
459815|NCT00462423|P1|Participant Flow|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
459816|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Avastin: Avastin 10 mg/kg IV every 2 weeks (without rest period).~Abraxane: Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle."
459817|NCT00462423|O1|Outcome|Single Arm, Open Label|"Single Arm, Open Label trial of Abraxane and Avastin~Abraxane and Avastin : Abraxane 150 mg/m2 IV weekly for 3 weeks of a 28-day cycle; Avastin 10 mg/kg IV every 2 weeks (without rest period)."
459821|NCT00462384|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459822|NCT00462384|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 micrograms per kilogram (mcg/kg) body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459823|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459824|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459825|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459826|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459827|NCT00462384|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459828|NCT00462384|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|Methoxy polyethylene glycol-epoetin beta was administered subcutaneously every 4 weeks (at Weeks 4, 8, 12, 16, 20, 24, 28 and 32). The starting dose was 1.2 mcg/kg body weight. Thereafter, throughout the duration of study the dose adjustments were performed depending on the hemoglobin value.
459829|NCT00462345|B1|Baseline|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459830|NCT00462345|P1|Participant Flow|Rituximab, Methotrexate|Participants received rituximab 1000 milligrams (mg), intravenously (IV), on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received methotrexate (MTX) 10 to 25 milligrams per week (mg/week), orally (PO) or parenterally, and folate at a stable dose of greater than or equal to (≥) 5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone less than or equal to (≤) 10 milligrams per day (mg/day), PO, OR equivalent corticosteroid, OR non-steroidal anti-inflammatory drugs (NSAIDs), PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459831|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459832|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459833|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459834|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459835|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459836|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459837|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459838|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459839|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459840|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459841|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459842|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459843|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459844|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459845|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459846|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459847|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
462372|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
459848|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459849|NCT00462345|O1|Outcome|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459850|NCT00462345|E1|Reported Event|Rituximab, Methotrexate|Participants received rituximab 1000 mg, IV, on Day 1 and Day 15; methylprednisolone 100 mg, IV, was administered 30 minutes before each infusion of rituximab. Participants also received MTX 10 to 25 mg/week, PO or parenterally, and folate at a stable dose of ≥5 mg/week, PO, either as a single dose or as divided daily doses from Day 1 through Week 24. Participants also received prednisone ≤10 mg/day, PO, OR equivalent corticosteroid, OR NSAIDs, PO, from Day 1 through Week 24. Eligible participants who completed the first 24-week course were entered into a second course.
459851|NCT00462332|B3|Baseline|Total|Total of all reporting groups
459852|NCT00462332|B2|Baseline|Low Risk Patients|Category of risk will be defined according to biological features.
459853|NCT00462332|B1|Baseline|High Risk Patientes|Category of risk will be defined according to biological features.
459854|NCT00462332|P2|Participant Flow|Low Risk Patients|Category of risk will be defined according to biological features.
459855|NCT00462332|P1|Participant Flow|High Risk Patientes|Category of risk will be defined according to biological features.
459856|NCT00462332|O2|Outcome|Low Risk Patients|Category of risk will be defined according to biological features.
459857|NCT00462332|O1|Outcome|High Risk Patientes|Category of risk will be defined according to biological features.
459858|NCT00462332|O2|Outcome|High Risk Patients|
459859|NCT00462332|O1|Outcome|Low Risk Patients|
459860|NCT00462332|E2|Reported Event|Low Risk Patients|Category of risk will be defined according to biological features.
459861|NCT00462332|E1|Reported Event|High Risk Patientes|Category of risk will be defined according to biological features.
459862|NCT00462306|B3|Baseline|Total|Total of all reporting groups
459863|NCT00462306|B2|Baseline|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
459864|NCT00462306|B1|Baseline|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
459865|NCT00462306|P2|Participant Flow|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
459866|NCT00462306|P1|Participant Flow|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
459867|NCT00462306|O2|Outcome|Negative Berlin Questionnaires|Pregnant Women with Results of Berlin Questionnaire not Indicative of Sleep Disordered Breathing
459868|NCT00462306|O1|Outcome|Positive Berlin Questionaires|Pregnant Women with Berlin Questionnaire Responses Indicative of Sleep Disordered Breathing
459869|NCT00462306|O2|Outcome|Non-Pregnant Women|Non-pregnant women undergoing a surgical procedure
459870|NCT00462306|O1|Outcome|Pregnant Women|
459871|NCT00462306|E2|Reported Event|Non-Pregnant Population|The study group consisted of non-pregnant females, presenting to Northwestern Memorial Hospital for ambulatory surgery
459872|NCT00462306|E1|Reported Event|Pregnant Population|The study group consisted of pregnant women, presenting to Prentice Women's Hospital of Northwestern Memorial Hospital for spontaneous labor, induction of labor, and scheduled cesarean delivery.
459873|NCT00462280|B5|Baseline|Total|Total of all reporting groups
459874|NCT00462280|B4|Baseline|One Large Nevi Group-Placebo|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459875|NCT00462280|B3|Baseline|One Large Nevi Group-Lovastatin|"Patients with one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459876|NCT00462280|B2|Baseline|Two Matched Nevi Group-Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459877|NCT00462280|B1|Baseline|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459878|NCT00462280|P4|Participant Flow|One Large Nevi Group - Placebo|"Patients who have one large nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459879|NCT00462280|P3|Participant Flow|One Large Nevi Group - Lovastatin|"Patients who have one large nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459880|NCT00462280|P2|Participant Flow|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459881|NCT00462280|P1|Participant Flow|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459882|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459883|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459884|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459885|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459886|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459887|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459888|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459889|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459890|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459891|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459892|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459893|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459894|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459895|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459896|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459897|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459898|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459899|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459900|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459947|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459948|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459901|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459902|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459903|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459904|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459905|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459906|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459907|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459908|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459909|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459910|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459911|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459912|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459913|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459914|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459915|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459916|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459917|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459918|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459919|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459920|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459949|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459921|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459922|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459923|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459924|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459925|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459926|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459927|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459928|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459929|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459930|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459931|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm.~Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459932|NCT00462280|O2|Outcome|Placebo|"One Large Nevi Group-Placebo and Two Matched Nevi Group-Placebo arms are combined into the Placebo arm. Patients received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459933|NCT00462280|O1|Outcome|Lovastatin|"One Large Nevi Group-Lovastatin and Two Matched Nevi Group-Lovastatin arms are combined into the Lovastatin arm. Patients received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459934|NCT00462280|O2|Outcome|Two Matched Nevi Group - Placebo|"Patients with two matched nevi received placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459935|NCT00462280|O1|Outcome|Two Matched Nevi Group - Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459936|NCT00462280|E4|Reported Event|One Large Nevi Group-Placebo|Patients who have one large nevi receive placebo PO QD for up to 6 months
459937|NCT00462280|E3|Reported Event|One Large Nevi Group-Lovastatin|Patients who have one large nevi received lovastatin PO QD for up to 6 months
459938|NCT00462280|E2|Reported Event|Two Matched Nevi Group-Placebo|"Patients receive placebo PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459939|NCT00462280|E1|Reported Event|Two Matched Nevi Group-Lovastatin|"Patients with two matched nevi received lovastatin PO QD for up to 6 months in the absence of disease progression or unacceptable toxicity.~lovastatin: Given PO~biopsy: Correlative studies~laboratory biomarker analysis: Correlative studies"
459940|NCT00462228|B1|Baseline|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design.
459941|NCT00462228|P1|Participant Flow|Overall Study|All 11 baseline subjects completed the three periods of the study: memantine treatment, placebo treatment, and no treatment (washout period) in this crossover design. Five subjects were randomized to begin the study by taking memantine and crossover to placebo; seven subjects began with placebo and crossed over to memantine.
459942|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459943|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459944|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459945|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459946|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459951|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459952|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459953|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459954|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459955|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459956|NCT00462228|O2|Outcome|Placebo|All subject scores for placebo regardless of sequence in the crossover design.
459957|NCT00462228|O1|Outcome|Memantine|All subject scores for memantine regardless of sequence in the crossover design.
459958|NCT00462228|E3|Reported Event|No Treatment (Washout)|All 11 subjects completed a 4 week washout between memantine and placebo arms and a 4 week washout at the end of the study.
459959|NCT00462228|E2|Reported Event|Memantine|All 11 subjects completed 12 weeks of memantine treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
459960|NCT00462228|E1|Reported Event|Placebo|All 11 subjects completed 12 weeks of placebo treatment. Subjects were given 5 mg per day for 7 days, then 5 mg twice per day for 7 days, then 10 mg AM, 5 mg PM for 7 days, then 10 mg twice daily, as tablet form.
459961|NCT00462072|B4|Baseline|Total|Total of all reporting groups
459962|NCT00462072|B3|Baseline|Psoriasis (Ps)|Ps subjects starting Infliximab
459963|NCT00462072|B2|Baseline|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab
459964|NCT00462072|B1|Baseline|Rheumatoid Arthritis (RA)|RA subject starting Infliximab
459965|NCT00462072|P3|Participant Flow|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
459966|NCT00462072|P2|Participant Flow|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
459967|NCT00462072|P1|Participant Flow|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
459968|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
459969|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
459970|NCT00462072|O1|Outcome|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
459971|NCT00462072|O2|Outcome|Rheumatoid Arthritis|RA subjects taking Infliximab as part of their standard of care.
459972|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
459973|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
459974|NCT00462072|O1|Outcome|Psoriariatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
459975|NCT00462072|O2|Outcome|Rheumatoid Arthritis (RA)|RA subjects starting Infliximab as part of their standard of care.
459976|NCT00462072|O1|Outcome|Psoriatic Arthritis (PsA)|PsA subjects starting Infliximab as part of their standard of care.
459977|NCT00462072|E3|Reported Event|Rheumatoid Arthritis (RA)|RA subjects taking Infliximab as part of their standard of care.
459978|NCT00462072|E2|Reported Event|Psoriatic Arthritis (PsA)|PsA subjects taking Infliximab as part of their standard of care.
459979|NCT00462072|E1|Reported Event|Psoriasis (Ps)|Ps subjects taking Infliximab as part of their standard of care.
459980|NCT00462020|B3|Baseline|Total|Total of all reporting groups
459981|NCT00462020|B2|Baseline|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
459982|NCT00462020|B1|Baseline|IV Only|5 days of IV antibiotics after appendectomy
459983|NCT00462020|P2|Participant Flow|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
459984|NCT00462020|P1|Participant Flow|IV Only|5 days of IV antibiotics after appendectomy
459985|NCT00462020|O2|Outcome|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
459986|NCT00462020|O1|Outcome|IV Only|5 days of IV antibiotics after appendectomy
459987|NCT00462020|E2|Reported Event|IV and Oral Abx|home on oral antibiotics to complete 7 days of treatment when tolerating PO's
459988|NCT00462020|E1|Reported Event|IV Only|5 days of IV antibiotics after appendectomy
459989|NCT00461981|B3|Baseline|Total|Total of all reporting groups
459990|NCT00461981|B2|Baseline|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
459991|NCT00461981|B1|Baseline|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
459992|NCT00461981|P2|Participant Flow|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
459993|NCT00461981|P1|Participant Flow|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
459994|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
459995|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
459996|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
459997|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
459998|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
459999|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460000|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460001|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460002|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460003|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460004|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460005|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460006|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460007|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460008|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460009|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460010|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460011|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460012|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460013|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460014|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460015|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460016|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460017|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460018|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460019|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460020|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460021|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460022|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460023|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460024|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460025|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460026|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460027|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460028|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460029|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460030|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460031|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460032|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460033|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460034|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460035|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460036|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460037|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460038|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460039|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460040|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460041|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460042|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460043|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460044|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460045|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460046|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460047|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460048|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460049|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460050|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460051|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460052|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460053|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460054|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460055|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460056|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460057|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460058|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460059|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460060|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460061|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460062|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460063|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460064|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460065|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460066|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460067|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460068|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460069|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460070|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460071|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460072|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460073|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460074|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460075|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460076|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460077|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460078|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460079|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460080|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460081|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460082|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460083|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460084|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460085|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460086|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460087|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460088|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460089|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460090|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460091|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460092|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460093|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460094|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460095|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460096|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460097|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460098|NCT00461981|O2|Outcome|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460099|NCT00461981|O1|Outcome|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460100|NCT00461981|E2|Reported Event|TIV, Trivalent Inactivated Influenza Virus Vaccine|TIV, Trivalent Inactivated Influenza Virus Vaccine, Intramuscular, 0.25 mL will be administered intramuscularly for each of two doses
460101|NCT00461981|E1|Reported Event|FluMist, Influenza Virus Vaccine Live|FluMist, Influenza Virus Vaccine Live, Intranasal, 0.25 mL will be administered intranasally for each of two doses
460102|NCT00461851|B1|Baseline|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
460194|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460103|NCT00461851|P1|Participant Flow|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
460104|NCT00461851|O1|Outcome|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
460105|NCT00461851|E1|Reported Event|Chemotherapy Plus Sorafenib|"Gemcitabine 1000 mg/m2 weekly x 2 weeks plus carboplatin AUC (Area under curve) 5 every 3 weeks plus sorafenib x 6 cycles then maintenance sorafenib alone~Gemcitabine: Gemcitabine will be given at a standard dose schedule of 1000 mg/m² on day 1 and 8.~Carboplatin: Carboplatin will be given on day 1 to an AUC of 5.~Sorafenib: Sorafenib will be administered orally daily on days 2-19 at 400 mg bid"
460106|NCT00461786|B1|Baseline|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460107|NCT00461786|P1|Participant Flow|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460108|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460109|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460110|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460111|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460112|NCT00461786|O1|Outcome|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460113|NCT00461786|E1|Reported Event|Pemetrexed|Pemetrexed 900 mg/m2, intravenous (IV), every 21 days, until disease progression
460114|NCT00460993|B3|Baseline|Total|Total of all reporting groups
460115|NCT00460993|B2|Baseline|Group 2|"Sugar pill packaged and supplied by Sepracor. One pill weeks one and two of intervention.~Weeks 3 and 4 this Placebo group crosses over to active drug. 1 mg week 3 increasing to 2mg week 4 if sleep efficiency does not improve."
460116|NCT00460993|B1|Baseline|Group 1|Lunesta Active drug (eszopiclone) 1 mg during 1st week of active drug. If sleep efficiency does not improve does increases to 2 mg for 2nd week of active drug administration.
460117|NCT00460993|P2|Participant Flow|Group 2|Placebo during phase 1, then active drug phase 2. One placebo for 6 days
460118|NCT00460993|P1|Participant Flow|Group 1|Active drug during phase 1, then placebo during phase 2. Lunesta Active drug (eszopiclone) 1 mg for 3 days. If sleep efficiency does not improve in 3 three day, dose increases to 2 mg for the next three days of active drug administration.
460119|NCT00460993|O2|Outcome|Group 2|Placebo pill in phase 1, then Active drug given in phase 2. One placebo pill for 6 days
460120|NCT00460993|O1|Outcome|Group 1|Active drug given in phase 1, then Placebo pill in phase 2. Lunesta Active drug (eszopiclone) 1 mg during three days of active drug. If sleep efficiency does not improve doses increases to 2 mg for the next three days of active drug administration.
460121|NCT00460993|E2|Reported Event|Group 2|Placebo pill given in phase 1, then active drug give in phase 2. One placebo pill for 6 days.
460122|NCT00460993|E1|Reported Event|Group 1|Active drug given in phase 1, then placebo pill given in phase 2.
460123|NCT00461708|B3|Baseline|Total|Total of all reporting groups
460124|NCT00461708|B2|Baseline|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460125|NCT00461708|B1|Baseline|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460126|NCT00461708|P2|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Greater Than/Equal to (≥) 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460127|NCT00461708|P1|Participant Flow|Erlotinib, Gemcitabine: Rash Grade Less Than (<) 2|Participants with a rash Grade < 2 according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) version (V) 3.0 received erlotinib, 100 milligrams (mg), orally (PO), once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 milligrams per square meter (mg/m^2), intravenously (IV), over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460128|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460195|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460196|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460129|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460130|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460131|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460132|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460133|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460134|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460135|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460136|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460137|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460138|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460139|NCT00461708|O3|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460140|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade 1|Participants with a rash Grade 1 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460141|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade 0|Participants with a rash Grade 0 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460197|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460198|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460142|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460143|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460144|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460145|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460146|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460147|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460148|NCT00461708|O2|Outcome|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460149|NCT00461708|O1|Outcome|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460150|NCT00461708|E2|Reported Event|Erlotinib, Gemcitabine: Rash Grade ≥ 2|Participants with a rash Grade ≥ 2 according to the NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460151|NCT00461708|E1|Reported Event|Erlotinib, Gemcitabine: Rash Grade < 2|Participants with a rash Grade < 2 according to the National NCI-CTC V 3.0 received erlotinib, 100 mg, PO, once per day of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant. Participants also received gemcitabine, 1000 mg/m^2, IV, over 30 minutes on Days 1, 8 and 15 of Cycles 1 up through a maximum of Cycle 24 (4-week cycles) until disease progression, unacceptable toxicity, or treatment refusal by participant.
460152|NCT00461630|B3|Baseline|Total|Total of all reporting groups
460153|NCT00461630|B2|Baseline|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460154|NCT00461630|B1|Baseline|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460155|NCT00461630|P2|Participant Flow|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460156|NCT00461630|P1|Participant Flow|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460157|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460158|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460159|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460160|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460161|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460162|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460163|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460164|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460165|NCT00461630|O2|Outcome|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460166|NCT00461630|O1|Outcome|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460167|NCT00461630|E2|Reported Event|Placebo|Placebo (for ER niacin/laropiprant) 2 tablets orally per day. With either 40 mg simvastatin tablet orally per day or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460168|NCT00461630|E1|Reported Event|ER Niacin/Laropiprant|I g ER niacin plus 20mg laropiprant per tablet. 2 tablets orally per day. With either 40 mg simvastatin tablet or ezetimibe/simvastatin (10 mg/40 mg) in single tablet taken once daily
460169|NCT00461513|B3|Baseline|Total|Total of all reporting groups
460170|NCT00461513|B2|Baseline|Usual Care Group|Baseline characteristics of patients who enrolled and were randomized to the Usual Care Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months).Therefore the total number completed in the Usual Care Arm was 172, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 197 patients.
460171|NCT00461513|B1|Baseline|Intervention Group|Baseline characteristics of patients who enrolled and were randomized to the Intervention Group, and who had at least one follow-up Kansas City Cardiomyopathy Questionnaire (at 3, 6, or 12 months). Therefore the total number completed in the Intervention Arm was 165, but we had at least one follow-up Kansas City Cardiomyopathy Questionnaire result on 187 patients.
460172|NCT00461513|P2|Participant Flow|Usual Care|Patients randomized to the usual care arm continued to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group were given information sheets that outlined self-care for CHF, and provided with a scale if needed at the enrollment visit. Patients in the usual care group had the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients were notified of the results of all screening studies (patient survey results, lab tests).
460173|NCT00461513|P1|Participant Flow|Intervention|The PCDM intervention included evaluation of CHF care by the collaborative care (CC) team with treatment recommendations based on current ACC/AHA clinical practice guidelines, telemonitoring, and screening and treatment for comorbid depression. The CC team at each site included a primary care provider, cardiologist and psychiatrist, as well as nurse and pharmacist. For each intervention patient, there was initial assessment of care following the enrollment visit. Each intervention patient was re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients had daily telemonitoring, and their care was reviewed if the telemonitoring data suggested clinical deterioration.
460174|NCT00461513|O2|Outcome|Usual Care|
460175|NCT00461513|O1|Outcome|Intervention|
460176|NCT00461513|E2|Reported Event|Usual Care|
460177|NCT00461513|E1|Reported Event|Intervention|
460178|NCT00461500|B3|Baseline|Total|Total of all reporting groups
460179|NCT00461500|B2|Baseline|FP 100: Fluticasone Propionate.|Analysis population used in this arm is ITT population(Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
460180|NCT00461500|B1|Baseline|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|Analysis population used in this arm is ITT (intent-to-treat) population (Randomised subjects who received at least one dose of study drug and with evaluation for at least one efficacy criteria).
460181|NCT00461500|P2|Participant Flow|FP (Fluticasone Propionate)100|Analysis population are all randomized subjects in this arm. 100ug - one inhalation twice daily
460182|NCT00461500|P1|Participant Flow|SFC (Salmeterol Xinafoate/Fluticasone Propionate Combination)|Analysis population are all randomized subjects in this arm. 50/100ug - one inhalation twice daily
460183|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460184|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460185|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460186|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460187|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460188|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460189|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460190|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460191|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460192|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460193|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460200|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460201|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460202|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460203|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460204|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460205|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460206|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460207|NCT00461500|O2|Outcome|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460208|NCT00461500|O1|Outcome|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460209|NCT00461500|E2|Reported Event|FP 100: Fluticasone Propionate|100ug - one inhalation twice daily
460210|NCT00461500|E1|Reported Event|SFC 100: Salmeterol Xinafoate/Fluticasone Propionate Combined|50/100ug - one inhalation twice daily
460211|NCT00461331|B1|Baseline|Entire Study Population|These are the characteristics of the entire study population.
460212|NCT00461331|P2|Participant Flow|Lispro First, Washout, Then Aspart|Patients used Lispro Insulin for up to 100 hours, then entered a two week wash out period, then used Aspart insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
460213|NCT00461331|P1|Participant Flow|Aspart First, Washout, Then Lispro|Patients used Aspart Insulin for up to 100 hours, then entered a two week wash out period, then used Lispro insulin for up to 100 hours. Patients used the insulin at the same dose that they were using prior to entering the study.
460214|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
460215|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
460216|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
460217|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
460218|NCT00461331|O2|Outcome|Insulin Lispro|Patients were randomized to either insulin aspart or lispro first in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
460219|NCT00461331|O1|Outcome|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
460220|NCT00461331|E2|Reported Event|Insulin Lispro|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Lispro.
460221|NCT00461331|E1|Reported Event|Insulin Aspart|Patients were randomized to either insulin aspart or lispro in test period 1. They used that insulin for upto 100 hours and then switched to the other insulin after a wash out period of up to 2 weeks. Patients used the insulin at the same dose that they were using prior to entering the study. Post-study, glucose readings were grouped according to insulin type and patients ability to maintain Glycemic control(maintaing a glucose level between 180 to 300 mg/dL 24 to 100 hrs after last pump infusion line change)was analyzed for that particular insulin, in this arm- Aspart.
460222|NCT00461305|B3|Baseline|Total|Total of all reporting groups
460223|NCT00461305|B2|Baseline|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460384|NCT00460811|P5|Participant Flow|Matching Placebo|Dose-matched placebo, oral administration, once per day
460224|NCT00461305|B1|Baseline|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460225|NCT00461305|P2|Participant Flow|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460226|NCT00461305|P1|Participant Flow|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460227|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460228|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460229|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460230|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460231|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460232|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460233|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460234|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460235|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460236|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460237|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460238|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460239|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460240|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460241|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460242|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460243|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460244|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460245|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460246|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460247|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460248|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460249|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460250|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460251|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460252|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460376|NCT00461032|E2|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460253|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460254|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460255|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460256|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460257|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460258|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460259|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460260|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460261|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460262|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460263|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460264|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460265|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460266|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460267|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460268|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460269|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460270|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460271|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460272|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460273|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460274|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460275|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460276|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460277|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460278|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460279|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460280|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460281|NCT00461305|O2|Outcome|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460377|NCT00461032|E1|Reported Event|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460282|NCT00461305|O1|Outcome|DRSP 3 mg/EE 20 µg (6 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460283|NCT00461305|E2|Reported Event|DRSP 3 mg/EE 30 µg (6 Cycles)|1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)
460284|NCT00461305|E1|Reported Event|DRSP 3 mg/EE 20 µg (13 Cycles)|1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)
460285|NCT00461292|B4|Baseline|Total|Total of all reporting groups
460286|NCT00461292|B3|Baseline|Placebo|Normal saline (placebo)
460287|NCT00461292|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460288|NCT00461292|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460289|NCT00461292|P3|Participant Flow|Placebo|Normal saline (placebo)
460290|NCT00461292|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460291|NCT00461292|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460292|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
460293|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460294|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460295|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
460296|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460297|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460298|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
460299|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460300|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460301|NCT00461292|O3|Outcome|Placebo|Normal saline (placebo)
460302|NCT00461292|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460303|NCT00461292|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460304|NCT00461292|E3|Reported Event|Placebo|Normal saline (placebo)
460305|NCT00461292|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
460306|NCT00461292|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
460307|NCT00461253|B3|Baseline|Total|Total of all reporting groups
460308|NCT00461253|B2|Baseline|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
460309|NCT00461253|B1|Baseline|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
460310|NCT00461253|P2|Participant Flow|Controls|Controls were selected randomly from the national population registry (Finland) or via neighborhood controls by a controlled random route method (Germany).
460311|NCT00461253|P1|Participant Flow|Cases|Cases were defined as women who were diagnosed with breast cancer (invasive carcinoma or carcinoma in situ) between 1/2000 and 12/2007 and aged <50 years at diagnosis.
460312|NCT00461253|O2|Outcome|Cu-IUD|Women who currently or ever used a copper IUDs at time of breast cancer diagnosis
460313|NCT00461253|O1|Outcome|LNG IUD|Women who currently or ever used a LNG IUDs (Mirena) at time of breast cancer diagnosis
460314|NCT00461253|E2|Reported Event|Cu-IUD|Users of copper IUDs
460315|NCT00461253|E1|Reported Event|LNG IUD|Users of LNG IUDs (Mirena)
460316|NCT00461175|B3|Baseline|Total|Total of all reporting groups
460317|NCT00461175|B2|Baseline|Copper IUD|New users of Copper IUD
460318|NCT00461175|B1|Baseline|LNG IUS|New users of Mirena® IUS
460319|NCT00461175|P2|Participant Flow|Copper IUD|New users of Copper IUD
460320|NCT00461175|P1|Participant Flow|LNG IUS|New users of Mirena® IUS
460321|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
460322|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
460323|NCT00461175|O2|Outcome|Copper IUD|New users of Copper IUD
460324|NCT00461175|O1|Outcome|LNG IUS|New users of Mirena® IUS
460325|NCT00461175|E2|Reported Event|Copper IUD|New users of Copper IUD
460326|NCT00461175|E1|Reported Event|LNG IUS|New users of Mirena® IUS
460327|NCT00461123|B3|Baseline|Total|Total of all reporting groups
460328|NCT00461123|B2|Baseline|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460329|NCT00461123|B1|Baseline|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460330|NCT00461123|P2|Participant Flow|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460331|NCT00461123|P1|Participant Flow|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460332|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460333|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460334|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460378|NCT00460811|B6|Baseline|Total|Total of all reporting groups
460335|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460336|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460337|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460338|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460339|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460340|NCT00461123|O2|Outcome|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460341|NCT00461123|O1|Outcome|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460342|NCT00461123|E2|Reported Event|Placebo|One placebo tablet with a glass of water the evening before ablation of prostate; the second placebo dose with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences
460343|NCT00461123|E1|Reported Event|Vardenafil (Levitra, BAY38-9456)|One tablet vardenafil 10 mg with a glass of water the evening before ablation of prostate; the second dose (vardenafil 20 mg) with a glass of water approximately one hour before GreenlightTM laser ablation of prostate commences.
460344|NCT00461097|B3|Baseline|Total|Total of all reporting groups
460345|NCT00461097|B2|Baseline|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460346|NCT00461097|B1|Baseline|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460347|NCT00461097|P2|Participant Flow|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460348|NCT00461097|P1|Participant Flow|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460349|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460350|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460351|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460352|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460353|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460354|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460355|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460356|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460379|NCT00460811|B5|Baseline|Matching Placebo|Dose-matched placebo, oral administration, once per day
460380|NCT00460811|B4|Baseline|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460381|NCT00460811|B3|Baseline|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460382|NCT00460811|B2|Baseline|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460383|NCT00460811|B1|Baseline|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460357|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460358|NCT00461097|O2|Outcome|Placebo|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460359|NCT00461097|O1|Outcome|Egg Oral Immunotherapy (OIT)|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day for the remainder of the study (1-3 years). A 10 gm OFC to identify desensitized [1] subjects occurs at specified intervals under prescribed conditions (yrs 2 - 4). Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460360|NCT00461097|E3|Reported Event|Egg Oral Immunotherapy (OIT), 2-4 Years|"Subjects who failed the 1st or 2nd 10 gm OFC at month 22 or year 2 continue on their egg OIT maintenance dose of 2 gm/day of egg white solid (EWS) or are allowed to attempt escalation up to 2 gm/day for the remainder of the study. Subjects who are not considered tolerant may have a 10 gm OFC at year 3 and year 4 to assess desensitization. Subjects who pass the 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.~Note: The total number of subjects assessed for non-systematic adverse events was 36 (subjects with post 2-year follow-up) and for systematic adverse events was 22 (subjects with post 2-year dosing)."
460361|NCT00461097|E2|Reported Event|Placebo, 0-2 Years|Subjects ingest placebo (cornstarch) during Visit 1 (initial day of dose escalation up to 50 mg), followed by a build-up phase (escalating daily placebo doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects were on a maximally tolerated daily placebo dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects were given a 5 gm Oral Food Challenge (OFC) using egg white solid to identify desensitized [1] subjects. Subjects/study staff were unblinded following this initial 5 gm OFC. After unblinding, subjects discontinued further placebo dosing and continued on an egg-restricted diet. A 10 gm OFC was administered under prescribed conditions to subjects if their egg-specific serum IgE level was below 2 kUA/L. They were followed in the study up to 2 years. [1] Desensitized: Subject does not react to egg during OFC while taking daily doses of therapy. [2] Tolerant: Subject does not react to egg during OFC 4-6 wks after abstinence from egg consumption.
460362|NCT00461097|E1|Reported Event|Egg Oral Immunotherapy (OIT), 0-2 Years|Subjects ingest egg white solid (EWS) on Visit 1 (initial day dose escalation up to 50 mg), followed by a build-up phase (escalating daily egg doses every 2 wks, achieving a maintenance dose by 32-40 wks). Thereafter, subjects are on a maximally tolerated daily egg dose (306 mg to 2 gm) for ≥8 wks. After wk 44, subjects are given a 5 gm Oral Food Challenge (OFC) using EWS to identify desensitized [1] subjects. Subjects/study staff are unblinded following this OFC and either continue on their egg OIT maintenance dose of 2 gm/day or are allowed to attempt escalation up to 2 gm/day. A 10 gm OFC to identify desensitized [1] subjects occurs at month 22. Subjects who pass this 1st 10 gm OFC stop study therapy for 4-6 wks, then have a 2nd 10 gm OFC at year 2. Subjects that pass this 2nd 10 gm OFC are considered tolerant [2], stop EWS dosing and add egg to their diet.
460363|NCT00461032|B3|Baseline|Total|Total of all reporting groups
460364|NCT00461032|B2|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460365|NCT00461032|B1|Baseline|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460366|NCT00461032|P2|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460367|NCT00461032|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460368|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460369|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460370|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460371|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460372|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460373|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460374|NCT00461032|O2|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet taken orally once daily (OD) at bedtime for 8 weeks.
460375|NCT00461032|O1|Outcome|Placebo|Montelukast matching-image placebo tablet taken orally once daily at bedtime for 8 weeks.
460385|NCT00460811|P4|Participant Flow|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460386|NCT00460811|P3|Participant Flow|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460387|NCT00460811|P2|Participant Flow|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460388|NCT00460811|P1|Participant Flow|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460389|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
460390|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460391|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460392|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460393|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460394|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
460395|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460396|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460397|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460398|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460399|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
460400|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460401|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460402|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460403|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460404|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day
460405|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460406|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460407|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460408|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460409|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
460410|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460411|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460412|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460413|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460414|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
460415|NCT00460811|O4|Outcome|579 μg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460416|NCT00460811|O3|Outcome|290 μg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460417|NCT00460811|O2|Outcome|145 μg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460418|NCT00460811|O1|Outcome|72 μg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460419|NCT00460811|O5|Outcome|Matching Placebo|Dose-matched placebo, oral administration, once per day.
460420|NCT00460811|O4|Outcome|579 ug Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460421|NCT00460811|O3|Outcome|290 ug Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460422|NCT00460811|O2|Outcome|145 ug Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460423|NCT00460811|O1|Outcome|72 ug Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460424|NCT00460811|E5|Reported Event|Matching Placebo|Dose-matched placebo, oral administration, once per day
460425|NCT00460811|E4|Reported Event|579 µg Linaclotide Acetate|Linaclotide, 579μg dose, oral administration, once per day
460426|NCT00460811|E3|Reported Event|290 µg Linaclotide Acetate|Linaclotide, 290μg dose, oral administration, once per day
460427|NCT00460811|E2|Reported Event|145 µg Linaclotide Acetate|Linaclotide, 145μg dose, oral administration, once per day
460428|NCT00460811|E1|Reported Event|72 µg Linaclotide Acetate|Linaclotide, 72μg dose, oral administration, once per day
460429|NCT00460798|B1|Baseline|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460430|NCT00460798|P1|Participant Flow|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460431|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460478|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460479|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460432|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460433|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460434|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460435|NCT00460798|O1|Outcome|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460436|NCT00460798|E1|Reported Event|Sunitinib|Sunitinib malate (Sutent) was administered and dosed as stipulated in the Summary of Product Characteristics (SmPC) and was used solely in accordance with the medical and therapeutic needs. The recommended dose of Sutent was 50 mg once daily, administered orally over 4 weeks, followed by a rest period of 2 weeks (4/2 regimen). One treatment cycle = 6 weeks.
460437|NCT00460746|B1|Baseline|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460438|NCT00460746|P1|Participant Flow|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460439|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460440|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460441|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460442|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460443|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460444|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460445|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460446|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460447|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460448|NCT00460746|O1|Outcome|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460449|NCT00460746|E1|Reported Event|Darunavir(TMC114)/Eravirine(TMC125)|Darunavir/ritonavir (DRV/r) combined with Etravirine ([ETR] also known as TMC125) when current protease inhibitor(s) (PIs), non-nucleoside reverse transriptase inhibitor(s) (NNRTIs), and enfuviritide (ENF) were replaced by DRV/r and ETR in subjects with intolerance to ENF.
460450|NCT00460655|B3|Baseline|Total|Total of all reporting groups
460451|NCT00460655|B2|Baseline|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460452|NCT00460655|B1|Baseline|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460453|NCT00460655|P4|Participant Flow|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460480|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460454|NCT00460655|P3|Participant Flow|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460455|NCT00460655|P2|Participant Flow|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460456|NCT00460655|P1|Participant Flow|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460457|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460458|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460459|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460460|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460461|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460462|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460463|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460464|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460465|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460466|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460467|NCT00460655|O2|Outcome|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460468|NCT00460655|O1|Outcome|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460469|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460470|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460471|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460472|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460473|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460474|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460475|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460476|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460477|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460481|NCT00460655|O2|Outcome|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460482|NCT00460655|O1|Outcome|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460483|NCT00460655|E4|Reported Event|DB Placebo + OL BTX|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus BTX (GSK1358820) 300U in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460484|NCT00460655|E3|Reported Event|DB BTX + OL BTX|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of ankle >=2 and at least 12 weeks (84 days) since the last injection])
460485|NCT00460655|E2|Reported Event|Placebo|Placebo 24 mL was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460486|NCT00460655|E1|Reported Event|BTX 300U|BTX (GSK1358820) 300U (24 mL) was injected into the lower limb muscles in the 12-week double-blind phase (DB) (once at Week 0)
460487|NCT00460603|B13|Baseline|Total|Total of all reporting groups
460488|NCT00460603|B12|Baseline|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460489|NCT00460603|B11|Baseline|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460490|NCT00460603|B10|Baseline|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460491|NCT00460603|B9|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460492|NCT00460603|B8|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460493|NCT00460603|B7|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460494|NCT00460603|B6|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460624|NCT00460564|P8|Participant Flow|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460752|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460495|NCT00460603|B5|Baseline|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460496|NCT00460603|B4|Baseline|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460497|NCT00460603|B3|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460498|NCT00460603|B2|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460499|NCT00460603|B1|Baseline|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460500|NCT00460603|P12|Participant Flow|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460501|NCT00460603|P11|Participant Flow|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460502|NCT00460603|P10|Participant Flow|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460503|NCT00460603|P9|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460625|NCT00460564|P7|Participant Flow|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460504|NCT00460603|P8|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460505|NCT00460603|P7|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460506|NCT00460603|P6|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460507|NCT00460603|P5|Participant Flow|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460508|NCT00460603|P4|Participant Flow|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460509|NCT00460603|P3|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460510|NCT00460603|P2|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460511|NCT00460603|P1|Participant Flow|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1)|Bevacizumab 1 milligram per kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 milligram per square meter (mg/m^2) intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-fluorouracil (5-FU) 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460512|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460704|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460513|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460514|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460515|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460516|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460517|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460518|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460519|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460520|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460521|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460522|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460705|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460753|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460523|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460524|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460525|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460526|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460527|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460528|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460529|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460530|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460531|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460706|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460754|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460532|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460533|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460534|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460535|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460536|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460537|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460538|NCT00460603|O1|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460539|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460540|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460559|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460541|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460542|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460543|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460544|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460545|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460546|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460547|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460548|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460549|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460622|NCT00460564|B2|Baseline|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460623|NCT00460564|B1|Baseline|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460550|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460551|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460552|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460553|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460554|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460555|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460556|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460557|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460558|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460707|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460755|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460560|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460561|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460562|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460563|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460564|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460565|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460566|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460567|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460568|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460708|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460569|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460570|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460571|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1,2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460572|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460573|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460574|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460575|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460576|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460577|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460626|NCT00460564|P6|Participant Flow|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460578|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460579|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460580|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460581|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460582|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460583|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460584|NCT00460603|O3|Outcome|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460585|NCT00460603|O2|Outcome|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460586|NCT00460603|O1|Outcome|Phase 1: Axitinib + Bevacizumab + FOLFOX (Cohort 1-3)|Bevacizumab 1, 2 or 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460699|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460700|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460587|NCT00460603|O3|Outcome|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460588|NCT00460603|O2|Outcome|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460589|NCT00460603|O1|Outcome|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently with oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460590|NCT00460603|E12|Reported Event|Phase 2: Axitinib + Bevacizumab + FOLFOX|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460591|NCT00460603|E11|Reported Event|Phase 2: Bevacizumab + FOLFOX|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460592|NCT00460603|E10|Reported Event|Phase 2: Axitinib + FOLFOX|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily in each 14-day cycle administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460593|NCT00460603|E9|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 9)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460594|NCT00460603|E8|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 8)|Axitinib (AG-13736) tablet 7 mg orally twice daily for 7 days in 2-week lead-in period prior to Day 1 Cycle 1. FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 7 mg to 10 mg orally twice daily from Day 3 to Day 9 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460595|NCT00460603|E7|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 7)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460596|NCT00460603|E6|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 6)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily from Day 3 to Day 12 in each 14-day cycle administered following completion of 5-FU infusion on Day 3. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460747|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460597|NCT00460603|E5|Reported Event|Phase 1: Axitinib + FOLFOX (Cohort 5)|FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to oxaliplatin infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460598|NCT00460603|E4|Reported Event|Phase 1: Axitinib + FOLFIRI (Cohort 4)|FOLFIRI combination chemotherapy on Day 1 of each 14-day cycle consisting of irinotecan 180 mg/m^2 intravenous infusion over 90 minutes, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by irinotecan, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered prior to irinotecan infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460599|NCT00460603|E3|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 3)|Bevacizumab 5 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460600|NCT00460603|E2|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 2)|Bevacizumab 2 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460601|NCT00460603|E1|Reported Event|Phase 1: Axitinib + FOLFOX + Bevacizumab (Cohort 1)|Bevacizumab 1 mg/kg intravenous infusion over 90 minutes on Day 1 of each 14-day cycle followed by FOLFOX combination chemotherapy on Day 1 of each 14-day cycle consisting of oxaliplatin 85 mg/m^2 intravenous infusion over 2 hours, leucovorin 400 mg/m^2 intravenous infusion over 2 hours administered concurrently or followed by oxaliplatin, then 5-FU 400 mg/m^2 intravenous bolus injection and a subsequent 5-FU 2400 mg/m^2 intravenous infusion over 46 to 48 hours. Axitinib (AG-013736) tablet 5 mg orally twice daily starting from Day 3 in Cycle 1 and starting from Day 1 in all subsequent cycles administered following bevacizumab infusion on Day 1. Dose adjustment for any drug in the combination was done for individual participants who experienced drug-related toxicity, as per investigator's discretion.
460602|NCT00460577|B3|Baseline|Total|Total of all reporting groups
460603|NCT00460577|B2|Baseline|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460604|NCT00460577|B1|Baseline|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460605|NCT00460577|P2|Participant Flow|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460606|NCT00460577|P1|Participant Flow|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460607|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460608|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460609|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460610|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460611|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460612|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460613|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460614|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460615|NCT00460577|O2|Outcome|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460616|NCT00460577|O1|Outcome|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460617|NCT00460577|E2|Reported Event|Fenoterol 0.5 mg + Berodual®|Fenoterol 0.5 mg + Ipratropium Bromide (Berodual®) 0.25 mg 20 drops in 3 mL of saline solution nebulized.
460618|NCT00460577|E1|Reported Event|Formoterol (Foradil®)|Formoterol (Foradil®) 12 micrograms administered through Aerolizer®.
460619|NCT00460564|B5|Baseline|Total|Total of all reporting groups
460620|NCT00460564|B4|Baseline|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460621|NCT00460564|B3|Baseline|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
463643|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
460627|NCT00460564|P5|Participant Flow|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460628|NCT00460564|P4|Participant Flow|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460629|NCT00460564|P3|Participant Flow|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460630|NCT00460564|P2|Participant Flow|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460631|NCT00460564|P1|Participant Flow|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460632|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460633|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460634|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460635|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460636|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460637|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460638|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460639|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460640|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460641|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460642|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460701|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460643|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460644|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460645|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460646|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460647|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460648|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460649|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460650|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460651|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460652|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460653|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460654|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460655|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460656|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460702|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460748|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460657|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460658|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460659|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460660|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460661|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460662|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460663|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460664|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460665|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460666|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460667|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460668|NCT00460564|O4|Outcome|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460669|NCT00460564|O3|Outcome|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460670|NCT00460564|O2|Outcome|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460703|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460749|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460671|NCT00460564|O1|Outcome|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460672|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460673|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460674|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460675|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460676|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460677|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460678|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460679|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460680|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460681|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460682|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460683|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460684|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460685|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460686|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460687|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460688|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460689|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460690|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460691|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460692|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460693|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460694|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460695|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460696|NCT00460564|O4|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460697|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460698|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460750|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460709|NCT00460564|O3|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460710|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460711|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460712|NCT00460564|O2|Outcome|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460713|NCT00460564|O1|Outcome|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460714|NCT00460564|O2|Outcome|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460715|NCT00460564|O1|Outcome|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460716|NCT00460564|E8|Reported Event|DB Low-Dose Placebo + OL High-Dose BTX|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460717|NCT00460564|E7|Reported Event|DB Low-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460718|NCT00460564|E6|Reported Event|DB High-Dose Placebo + OL High-Dose BTX|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus high-dose BTX in open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460719|NCT00460564|E5|Reported Event|DB High-Dose BTX + OL High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0) plus the 36-week open-label phase (OL) following the DB phase (up to 3 times, from Week 12 to Week 36 if participant met re-injection criteria [Modified Ashworth Scale (MAS) score of wrist >=2 and at least 12 weeks (84 days) since the last injection])
460720|NCT00460564|E4|Reported Event|Low-Dose Placebo|Placebo 2.4 mL was injected into the wrist and finger muscles, and 0.6 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460721|NCT00460564|E3|Reported Event|Low-Dose BTX|BTX (GSK1358820) 120U (2.4 mL) was injected into the wrist and finger muscles, and 30U (0.6 mL) into the thumb muscles if thumb spasticity was present in double-blind phase in the 12-week (DB) (once at Week 0)
460722|NCT00460564|E2|Reported Event|High-Dose Placebo|Placebo 4 mL was injected into the wrist and finger muscles, and 0.8 mL into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460723|NCT00460564|E1|Reported Event|High-Dose BTX|BTX (GSK1358820) 200U (4 mL) was injected into the wrist and finger muscles, and 40U (0.8 mL) into the thumb muscles if thumb spasticity was present in the 12-week double-blind phase (DB) (once at Week 0)
460724|NCT00460551|B1|Baseline|Zalutumumab 8 mg/kg|
460725|NCT00460551|P1|Participant Flow|Zalutumumab 8 mg/kg|
460726|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
460727|NCT00460551|O1|Outcome|Zalatumumab 8 mg/kg|
460728|NCT00460551|E1|Reported Event|Zalutumumab 8 mg/kg|
460729|NCT00460525|B3|Baseline|Total|Total of all reporting groups
460730|NCT00460525|B2|Baseline|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460731|NCT00460525|B1|Baseline|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460732|NCT00460525|P2|Participant Flow|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460733|NCT00460525|P1|Participant Flow|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460734|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460735|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460736|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460737|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460738|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460739|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460740|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460741|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460742|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460743|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460744|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460745|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460746|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460756|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460757|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460758|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460759|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460760|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460761|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460762|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460763|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460764|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460765|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460766|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460767|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460768|NCT00460525|O2|Outcome|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460769|NCT00460525|O1|Outcome|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460770|NCT00460525|E2|Reported Event|FMP2.1/AS02A|50 mcg of FMP2.1 in 0.5 mL AS02A administered on Days 0, 30, and 60.
460771|NCT00460525|E1|Reported Event|Rabies Vaccine|Rabies vaccine administered on Days 0, 30, and 60.
460772|NCT00460421|B4|Baseline|Total|Total of all reporting groups
460773|NCT00460421|B3|Baseline|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460774|NCT00460421|B2|Baseline|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460775|NCT00460421|B1|Baseline|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460776|NCT00460421|P3|Participant Flow|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460777|NCT00460421|P2|Participant Flow|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460778|NCT00460421|P1|Participant Flow|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460779|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
460780|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460781|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460782|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460783|NCT00460421|O4|Outcome|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
460784|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460785|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460786|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460787|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460788|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460789|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460790|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460791|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460792|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460793|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460794|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460795|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460796|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460797|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460798|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460799|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460800|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460801|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
463644|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
460802|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460803|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460804|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460805|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460806|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460807|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460808|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460809|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460810|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460811|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460812|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460813|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460814|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460815|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460816|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460817|NCT00460421|O3|Outcome|Palifermin 80 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460818|NCT00460421|O2|Outcome|Palifermin 60 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460819|NCT00460421|O1|Outcome|Palifermin 40 µg/kg/Day|Three subjects from each age group (1-2, 3-11, 12-16 years) were sequentially enrolled into the 3 planned dosing cohorts
460820|NCT00460421|E1|Reported Event|All Subjects|All subjects from each age group (1-2, 3-11, 12-16 years)
460821|NCT00460408|B5|Baseline|Total|Total of all reporting groups
460822|NCT00460408|B4|Baseline|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460823|NCT00460408|B3|Baseline|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460824|NCT00460408|B2|Baseline|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460825|NCT00460408|B1|Baseline|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460826|NCT00460408|P4|Participant Flow|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460827|NCT00460408|P3|Participant Flow|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460828|NCT00460408|P2|Participant Flow|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460829|NCT00460408|P1|Participant Flow|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460830|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460831|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460832|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460833|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460834|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460835|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460836|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460837|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460838|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460839|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460840|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460841|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460842|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460843|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460844|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460845|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460846|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460847|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460848|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460849|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460850|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460851|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460852|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460853|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460854|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460855|NCT00460408|O4|Outcome|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460856|NCT00460408|O3|Outcome|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460893|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460894|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460857|NCT00460408|O2|Outcome|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460858|NCT00460408|O1|Outcome|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460859|NCT00460408|E4|Reported Event|Macugen and Other AMD Drugs|The use and dosage recommendations for Macugen (pegaptanib sodium) and other approved AMD drugs were in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular AMD is an off-label use. Participants could have received study drug in one eye or both eyes.
460860|NCT00460408|E3|Reported Event|Macugen and Lucentis|The use and dosage recommendations for Macugen (pegaptanib sodium) and Lucentis (ranibizumab) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460861|NCT00460408|E2|Reported Event|Macugen and Avastin|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Avastin (bevacizumab) for treatment of neovascular age-related macular degeneration (AMD) is an off-label use. Participants could have received study drug in one eye or both eyes.
460862|NCT00460408|E1|Reported Event|Macugen|The use and dosage recommendations for Macugen (pegaptanib sodium) was in accordance with the summary of product characteristics. Participants could have received study drug in one eye or both eyes.
460863|NCT00460265|B3|Baseline|Total|Total of all reporting groups
460864|NCT00460265|B2|Baseline|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460865|NCT00460265|B1|Baseline|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460866|NCT00460265|P2|Participant Flow|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460867|NCT00460265|P1|Participant Flow|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460868|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460869|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460870|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460871|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460872|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460873|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460874|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460875|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460876|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460877|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460878|NCT00460265|O2|Outcome|Chemotherapy Alone|Consists of Cisplatin and 5-FU
460879|NCT00460265|O1|Outcome|Panitumumab Plus Chemotherapy|Consists of Panitumumab plus Cisplatin and 5-FU
460880|NCT00460265|E2|Reported Event|Chemotherapy Alone|
460881|NCT00460265|E1|Reported Event|Panitumumab Plus Chemotherapy|
460882|NCT00460031|B1|Baseline|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460883|NCT00460031|P1|Participant Flow|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460884|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460885|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460886|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460887|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460888|NCT00460031|O1|Outcome|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460889|NCT00460031|E1|Reported Event|Ketoconazole Plus Lenalidomide|Ketoconazole will be administered daily on days 1-28 of the cycle at a dose of 400mg po tid with hydrocortisone 20mg po every morning and 10mg po at bedtime. Hydrocortisone will be given on a continuous basis. Lenalidomide will be administered daily at a dose of 25mg po qd on days 1-21 of the cycle.
460890|NCT00459979|B1|Baseline|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460891|NCT00459979|P1|Participant Flow|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460892|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
463645|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
460895|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460896|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460897|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460898|NCT00459979|O1|Outcome|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460899|NCT00459979|E1|Reported Event|Sunitinib|"sunitinib malate : Sunitinib will be dosed at 50 mg p.o. daily~conventional surgery : nephrectomy"
460900|NCT00459953|B3|Baseline|Total|Total of all reporting groups
460901|NCT00459953|B2|Baseline|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
460902|NCT00459953|B1|Baseline|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
460903|NCT00459953|P2|Participant Flow|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
460904|NCT00459953|P1|Participant Flow|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
460905|NCT00459953|O2|Outcome|Control Group|Monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
460906|NCT00459953|O1|Outcome|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
460907|NCT00459953|E2|Reported Event|Control Group|All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The control group received monthly follow-up phone calls for assessment purposes and to control for potential therapeutic effects associated with continued contact
460908|NCT00459953|E1|Reported Event|Extended Treatment|"extended cognitive behavioral treatment for smoking cessation; Participants receive an additional 9 sessions of cognitive behavior therapy~Extended treatment: All participants receive an open label phase treatment that includes nicotine patch and cognitive behavior therapy for a period of 10 weeks. The extended treatment group received an additional 9 sessions of cognitive and behavioral skills training."
460909|NCT00459875|B1|Baseline|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
460910|NCT00459875|P1|Participant Flow|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
460911|NCT00459875|O1|Outcome|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
460912|NCT00459875|E1|Reported Event|Sunitinib|"The treatment will include Sunitinib malate 50 mg self-administered orally, once daily in the evening, without regard to meals, for 4 consecutive weeks (28 days) followed by 2 weeks (14 days) off, to comprise a complete cycle of 6 weeks.~sunitinib malate"
460913|NCT00459862|B1|Baseline|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460914|NCT00459862|P1|Participant Flow|Arm I|Patients receive 800mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460915|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460916|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460917|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460918|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460919|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460920|NCT00459862|O1|Outcome|Arm I|Patients receive 800 mg oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460921|NCT00459862|E1|Reported Event|Arm I|Patients receive oral pazopanib hydrochloride once daily on days 1-21. Treatment repeats every 21 days for 2 years in the absence of disease progression or unacceptable toxicity.
460968|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460922|NCT00459810|B1|Baseline|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460923|NCT00459810|P1|Participant Flow|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460924|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460925|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460926|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460927|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460928|NCT00459810|O1|Outcome|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460929|NCT00459810|E1|Reported Event|Transdermal Estradiol and Paclitaxel Poliglumex|All subjects enrolled were treated with transdermal estradiol 0.2 mg/24 hours for 4 weeks followed by the same dose of transdermal estradiol and paclitaxel poliglumex PPX 150 mg/m2 IV every 28 days.
460930|NCT00459732|B3|Baseline|Total|Total of all reporting groups
460931|NCT00459732|B2|Baseline|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460932|NCT00459732|B1|Baseline|Zinc|25 mg of zinc as zn sulfate taken daily
460933|NCT00459732|P2|Participant Flow|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460934|NCT00459732|P1|Participant Flow|Zinc|25 mg of zinc as zn sulfate taken daily
460935|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460936|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
460937|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460938|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
460939|NCT00459732|O2|Outcome|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460940|NCT00459732|O1|Outcome|Zinc|25 mg of zinc as zn sulfate taken daily
460941|NCT00459732|E2|Reported Event|Placebo|daily capsule similar in size/color to zn was taken daily by this group
460942|NCT00459732|E1|Reported Event|Zinc|25 mg of zinc as zn sulfate taken daily
460943|NCT00459706|B3|Baseline|Total|Total of all reporting groups
460944|NCT00459706|B2|Baseline|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460945|NCT00459706|B1|Baseline|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460946|NCT00459706|P2|Participant Flow|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460947|NCT00459706|P1|Participant Flow|Enbrel 50 mg Autoinjector|Enbrel 50 milligram (mg) once weekly subcutaneously for 12 Weeks using autoinjector
460948|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460949|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460950|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460951|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460952|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460953|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460954|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460955|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460956|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460957|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460958|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460959|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460960|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460961|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460962|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460963|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460964|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460965|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460966|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460967|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461181|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
460969|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460970|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460971|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460972|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460973|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460974|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460975|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460976|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460977|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460978|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460979|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460980|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460981|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460982|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460983|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460984|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460985|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460986|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460987|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460988|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460989|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460990|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460991|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460992|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460993|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460994|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460995|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460996|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460997|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
460998|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
460999|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461000|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461001|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461002|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461003|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461004|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461005|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461006|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461007|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461008|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461009|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461010|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461011|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461012|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461013|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461014|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461015|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461016|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461017|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461018|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461019|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461020|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461021|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461022|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461023|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461024|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461025|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461026|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461027|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461028|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461029|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461030|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461031|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461032|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461033|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461034|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461035|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461036|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461037|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461038|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461039|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461040|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461041|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461042|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461043|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461044|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461045|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461046|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461047|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461048|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461049|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461050|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461051|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461052|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461053|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461054|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461055|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461056|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461057|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461058|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461059|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461060|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461061|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461062|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461063|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461064|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461065|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461066|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461067|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461068|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461069|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461070|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461071|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461072|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461073|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461074|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461075|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461076|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461077|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461078|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461079|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461080|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461081|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461082|NCT00459706|O2|Outcome|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461083|NCT00459706|O1|Outcome|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461084|NCT00459706|E2|Reported Event|Enbrel 50 mg Prefilled Syringe|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using prefilled syringe
461085|NCT00459706|E1|Reported Event|Enbrel 50 mg Autoinjector|Enbrel 50 mg once weekly subcutaneously for 12 Weeks using autoinjector
461086|NCT00459667|B4|Baseline|Total|Total of all reporting groups
461087|NCT00459667|B3|Baseline|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461088|NCT00459667|B2|Baseline|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461089|NCT00459667|B1|Baseline|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461090|NCT00459667|P3|Participant Flow|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461091|NCT00459667|P2|Participant Flow|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461092|NCT00459667|P1|Participant Flow|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461093|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461094|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461095|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461096|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461097|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461098|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461099|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461100|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461101|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461102|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461103|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461104|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461105|NCT00459667|O3|Outcome|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461106|NCT00459667|O2|Outcome|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461107|NCT00459667|O1|Outcome|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461108|NCT00459667|E3|Reported Event|IFNB-1b 250 mcg*|"Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day~*(Subjects who were administered Copaxone and subjects who had prematurely discontinued medication during BEYOND study.)"
461109|NCT00459667|E2|Reported Event|IFNB-1b 250 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 250 mcg administered s.c. every other day (double blind)
461110|NCT00459667|E1|Reported Event|IFNB-1b 500 mcg|Interferon beta 1b ([IFNB 1b] Betaseron) 500 mcg administered s.c. every other day (double blind)
461111|NCT00459537|B3|Baseline|Total|Total of all reporting groups
461112|NCT00459537|B2|Baseline|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461113|NCT00459537|B1|Baseline|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461114|NCT00459537|P2|Participant Flow|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461115|NCT00459537|P1|Participant Flow|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461116|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461117|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461118|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461119|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461120|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461121|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461122|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461123|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461124|NCT00459537|O2|Outcome|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461125|NCT00459537|O1|Outcome|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461126|NCT00459537|E2|Reported Event|Amorolfine|5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
461127|NCT00459537|E1|Reported Event|Terbinafine|10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
461128|NCT00459368|B3|Baseline|Total|Total of all reporting groups
461129|NCT00459368|B2|Baseline|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
461130|NCT00459368|B1|Baseline|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
461131|NCT00459368|P2|Participant Flow|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
461132|NCT00459368|P1|Participant Flow|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
461133|NCT00459368|O2|Outcome|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
461134|NCT00459368|O1|Outcome|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
461135|NCT00459368|E2|Reported Event|Usual Care|Physician practicing at control sites are given standard training in how to intervene on poor adherence, but no patient adherence information is provided to these clinicians via electronic prescribing software.
461136|NCT00459368|E1|Reported Event|Patient Medication Adherence Feedback|In this cluster-randomized trial physicians practicing at intervention clinic sites will receive adherence information on their patients with asthma who are currently taking an inhaled corticosteroid medication. This information will be available to them via our electronic prescribing software to discuss with patients at the time of the visit. Physicians at these sites also receive standardized training in how to interpret and intervene when poor adherence is identified.
461137|NCT00459355|B3|Baseline|Total|Total of all reporting groups
461138|NCT00459355|B2|Baseline|Checklist|Received conventional home safety checklist
461139|NCT00459355|B1|Baseline|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461140|NCT00459355|P2|Participant Flow|Checklist|Group receives conventional home safety checklist
461141|NCT00459355|P1|Participant Flow|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461142|NCT00459355|O2|Outcome|Conventional Safety Checklist|Comparison group received a conventional home safety checklist
461412|NCT00457821|B8|Baseline|Part 2: Placebo|Part 2: placebo q12h; 28 days
461143|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461144|NCT00459355|O2|Outcome|Checklist|Conventional home safety checklist
461145|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461146|NCT00459355|O2|Outcome|Checklist|non-intervention group received conventional home safety checklist
461147|NCT00459355|O1|Outcome|Home Safety Toolkit|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461148|NCT00459355|E4|Reported Event|Checklist:Caregivers|Control group receives conventional list of home safety recommendations
461149|NCT00459355|E3|Reported Event|Home Safety Toolkit:Caregivers|Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.
461150|NCT00459355|E2|Reported Event|Checklist:Care Recipients|Control group receives conventional list of home safety recommendations
461151|NCT00459355|E1|Reported Event|Home Safety Toolkit:Care Recipients|"Intervention group receives home safety tool-kit with education and self-efficacy materials to promote competence to make home safety modifications.~Home Safety Toolkit: Health literacy-verified booklet and home safety items to promote competence to make home safety modifications."
461152|NCT00459342|B1|Baseline|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
461153|NCT00459342|P1|Participant Flow|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
461154|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
461155|NCT00459342|O1|Outcome|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
461156|NCT00459342|E1|Reported Event|Dasatinib|Oral dasatinib 100 mg (two 50 mg tablets) twice daily on days 1-21. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
461157|NCT00459316|B5|Baseline|Total|Total of all reporting groups
461158|NCT00459316|B4|Baseline|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461159|NCT00459316|B3|Baseline|Group 2|Participants ≥11 to <25 years with CD4%<15
461160|NCT00459316|B2|Baseline|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461161|NCT00459316|B1|Baseline|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%<25
461162|NCT00459316|P3|Participant Flow|Group 3: Age ≥2 to <11, CD4%≥25|"Participants ≥2 to <11 years of age with CD4% at screening ≥ 25%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
461163|NCT00459316|P2|Participant Flow|Group 2: CD4%<15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening <15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible receiving Quadrivalent meningococcal conjugate vaccine at week 24.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
461164|NCT00459316|P1|Participant Flow|Group 1: CD4%≥15, Age ≤11 to <25|"Participants ≤11 to <25 years of age with CD4% at screening ≥15%; All receiving Quadrivalent meningococcal conjugate vaccine at entry, those who were eligible/randomized receiving Quadrivalent meningococcal conjugate vaccine at week 24, and 3 years.~Quadrivalent meningococcal conjugate vaccine: MCV4 vaccine (4 µg each of meningococcal A, C, Y, and W-135 polysaccharides conjugated to approximately 48 µg of diphtheria toxoid protein carrier ) was given by injection intramuscularly at least once and no more than two times for each participant, depending on adverse reactions."
461165|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25, 2 doses MCV4 vaccine
461166|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461167|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461168|NCT00459316|O2|Outcome|Group 3|Participants >=2 to <11 years of age with CD4% at screening ≥ 25%
461169|NCT00459316|O1|Outcome|Group 1|Participants ≤11 to <25 years of age with CD4% at screening ≥15%
461170|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461171|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461172|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461173|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461174|NCT00459316|O4|Outcome|Group 3: Age 6-<11|Participants 6 to <11 years with CD4%>=25
461175|NCT00459316|O3|Outcome|Group 3: Age 2-<6|Participants 2 to <6 years with CD4%>=25
461176|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461177|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461178|NCT00459316|O3|Outcome|Week 72|Group 2 participants at Week 72
461179|NCT00459316|O2|Outcome|Week 28|Group 2 participants at Week 28 (4 weeks after second vaccination)
461180|NCT00459316|O1|Outcome|Week 4|Group 2 participants at Week 4
461182|NCT00459316|O2|Outcome|Group 1B|Participants aged 11 to 24 with a CD4 percentage of or greater than 15%, 2 doses MCV4 vaccine
461183|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461184|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461185|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461186|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461187|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461188|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461189|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461190|NCT00459316|O3|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461191|NCT00459316|O2|Outcome|Group 1B|Participants ≥11 to <25 years with CD4%>15, 2 doses MCV4 vaccine
461192|NCT00459316|O1|Outcome|Group 1A|Participants ≥11 to <25 years with CD4%>15, 1 dose MCV4 vaccine
461193|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461194|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
461195|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461196|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
461197|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
461198|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
461199|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461200|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
461201|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
461202|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
461203|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461204|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
461205|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4%≥25
461206|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
461207|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461208|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
461209|NCT00459316|O4|Outcome|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461210|NCT00459316|O3|Outcome|Group 2|Participants ≥11 to <25 years with CD4%<15
461211|NCT00459316|O2|Outcome|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461212|NCT00459316|O1|Outcome|Group 1 (15<CD4%<25)|Participants ≥11 to <25 years with 15<CD4%≤25
461213|NCT00459316|E4|Reported Event|Group 3|Participants ≥ 2 to <11 years with CD4% ≥25
461214|NCT00459316|E3|Reported Event|Group 2|Participants ≥11 to <25 years with CD4%<15
461215|NCT00459316|E2|Reported Event|Group 1 (CD4%≥25)|Participants ≥11 to <25 years with CD4%≥25
461216|NCT00459316|E1|Reported Event|Group 1 (15<CD4%≤25)|Participants ≥11 to <25 years with 15<CD4%≤25
461217|NCT00459303|B1|Baseline|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
461218|NCT00459303|P1|Participant Flow|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye.
461219|NCT00459303|O2|Outcome|Aspheric Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
461220|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
461221|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
461222|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
461223|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(Tecnis Z9000,AMO) in the other eye.
461224|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
461225|NCT00459303|O2|Outcome|Aspherical Intraocular Lens|patients recieved cataract surgery and recived aspherical intraocuar lens(Tecnis Z9000, AMO) in the other eye.
461226|NCT00459303|O1|Outcome|Spherical Intraocular Lens|patients recieved cataract surgery and recived spherical intraocuar lens(SA60AT, Alcon) in one eye.
461227|NCT00459303|E1|Reported Event|Cataract Patients|Patients with clinically significant cataract received cataract surgery and implantation of aspherical IOL in one eye and spherical IOL in the contralateral eye
461228|NCT00459290|B1|Baseline|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461229|NCT00459290|P1|Participant Flow|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461230|NCT00459290|O3|Outcome|>=70|
461231|NCT00459290|O2|Outcome|60 <70|
461232|NCT00459290|O1|Outcome|< 60|
461233|NCT00459290|O2|Outcome|GOG Performance Status 1|Restricted in physically strenuous activity but ambulatory and able to carry out work of light or sedentary nature, e.g., light housework, office work.
461234|NCT00459290|O1|Outcome|GOG Performance Status 0|Fully active, able to carry on all pre-disease performance without restriction.
461235|NCT00459290|O2|Outcome|Platinum Sensitive|
461236|NCT00459290|O1|Outcome|Not Platinum Sensitive|
461237|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461238|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461239|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461240|NCT00459290|O1|Outcome|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461241|NCT00459290|E1|Reported Event|Mifepristone|Mifepristone 200 mg PO daily administered on a continuous basis (every 4 weeks considered as one cycle) until disease progression or adverse effects prohibit further therapy
461242|NCT00459186|B1|Baseline|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
461243|NCT00459186|P1|Participant Flow|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
461244|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
461245|NCT00459186|O1|Outcome|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
461246|NCT00459186|E1|Reported Event|RAD001 Followed by RAD001 + Docetaxel|RAD001 10 mg daily for 2 weeks, followed by RAD001 + Docetaxel at one of three doses: 5 mg RAD001 and docetaxel at 60 mg/m2, 10 mg RAD001 and docetaxel at 60 mg/m2, and 10 mg RAD001 and docetaxel at 70 mg/m2. RAD001 was given daily. Docetaxel was given every 3 weeks by intravenous infusion. Patients also received prednisone 5 mg by mouth twice daily.
461247|NCT00459134|B3|Baseline|Total|Total of all reporting groups
461248|NCT00459134|B2|Baseline|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
461249|NCT00459134|B1|Baseline|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
461250|NCT00459134|P2|Participant Flow|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
461251|NCT00459134|P1|Participant Flow|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
461252|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
461253|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
461254|NCT00459134|O2|Outcome|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
461255|NCT00459134|O1|Outcome|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
461256|NCT00459134|E2|Reported Event|Arm II: Placebo|"Patients receive oral placebo 3 pills twice daily~Placebo: Given orally"
461257|NCT00459134|E1|Reported Event|Arm I: ArginMax|"ArginMax® 3 pills twice daily~ArginMax: Given orally"
461258|NCT00459121|B1|Baseline|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
461259|NCT00459121|P1|Participant Flow|Zactima, Paclitaxel, Carboplatin|"Zactima- 100 mg orally daily, starting on day 1 of cycle 1. Paclitaxel- 200mg/m2 IV, every 3 weeks starting on day 1 of cycle 1. Carboplatin AUC6 IV, every 3 weeks starting on day 1 of cycle 1 Duration of each cycle: 21 days. The last dose of zactima will be on the first day of the last cycle.~Neoadjuvant Surgery: Surgical resection of the tumor will be performed after the resolution of all the adverse effects from the last cycle of treatment but no earlier than 3 weeks after the last cycle of treatment."
461260|NCT00459121|O1|Outcome|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
461261|NCT00459121|E1|Reported Event|Zactima+Carboplatin & Paclitaxel-assess Feasibility & Safety|Study closed before an evaluable number of participants could be accrued. No summary of statistics will be collected for two participants, per the statistician.
461262|NCT00459108|B1|Baseline|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
461263|NCT00459108|P1|Participant Flow|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
461264|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib twice daily at 70 mg on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
461265|NCT00459108|O1|Outcome|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
461266|NCT00459108|E1|Reported Event|Oral Dasatinib|"Patients receive oral dasatinib at 70 mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~dasatinib: Given orally"
461267|NCT00459056|B3|Baseline|Total|Total of all reporting groups
461413|NCT00457821|B7|Baseline|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
461268|NCT00459056|B2|Baseline|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
461269|NCT00459056|B1|Baseline|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
461270|NCT00459056|P2|Participant Flow|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCT for three months, then had a one month wash-out period, and then were randomized to Carvedilol CR + Lisinopril for the remaining three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, Lisinophil was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
461271|NCT00459056|P1|Participant Flow|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for three months, then had a one month wash-out period, and then were randomized to Lisinopril + HCT for the remaining three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
461272|NCT00459056|O2|Outcome|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisionopril +HCTZ for the first three months, then had a one month washout period, then were given Carvedilol CR + Lisinopril for the final three months. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week.
461273|NCT00459056|O1|Outcome|Carvedilol CR + Lisinopril, Then Lisinopril +HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a one month washout period, then were given Lisinopril + HCTZ for the final three months. Carvedilol CR was initiated at a dose of 20mg, once per day, then titrated to 40mg, once per day after one week. Lisinopril was initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day after one week. For the second phase, lisinopril was again initiated at a dose of 10mg, once per day, then titrated to 20mg, once per day, after one week. HCT was initiated at a dose of 12.5mg, once per day, then titrated to 25mg, once per day, after one week.
461274|NCT00459056|E2|Reported Event|Lisinopril + HCTZ, Then Carvedilol CR + Lisinopril|Participants were randomized to Lisinopril + HCTZ for the first three months, then had a washout period for one month, and then were given Carvedilol CR + Lisinopril for the final three months.
461275|NCT00459056|E1|Reported Event|Carvedilol CR + Lisinopril, Then Lisinopril + HCTZ|Participants were randomized to Carvedilol CR + Lisinopril for the first three months, then had a washout period for one month, and then were given Lisinopril + HCTZ for the final three months.
461276|NCT00459043|B3|Baseline|Total|Total of all reporting groups
461277|NCT00459043|B2|Baseline|Combination of Docetaxel and Zactima|
461278|NCT00459043|B1|Baseline|Docetaxel Single Agent|
461279|NCT00459043|P2|Participant Flow|2 Combination Docetaxel and ZD6474|"Docetaxel with ZD6474~Docetaxel 75 mg/m2 was administered every 21 days intravenously. ZD6474 (Vandetanib) at 100 mg was administered as a once daily tablet given orally."
461280|NCT00459043|P1|Participant Flow|1Docetaxel Single Agent|Docetaxel 75 mg/m2 was administered every 21 days intravenously.
461281|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
461282|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
461283|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
461284|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
461285|NCT00459043|O2|Outcome|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
461286|NCT00459043|O1|Outcome|1Docetaxel Single Agent|Docetaxel Alone
461287|NCT00459043|E2|Reported Event|2 Combination Docetaxel and ZD6474|Docetaxel with ZD6474
461288|NCT00459043|E1|Reported Event|1Docetaxel Single Agent|Docetaxel Alone
461289|NCT00458952|B3|Baseline|Total|Total of all reporting groups
461290|NCT00458952|B2|Baseline|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
461291|NCT00458952|B1|Baseline|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
461292|NCT00458952|P2|Participant Flow|>500 mCi|14 subjects received a mean dose of greater than 500 mCi of Ultratrace Iobenguane I 131
461293|NCT00458952|P1|Participant Flow|=< 500 mCi Ultratrace Iobenguane I 131|7 subjects received a mean dose less than or equal to 500 mCi of Ultratrace Iobenguane I 131
461294|NCT00458952|O1|Outcome|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
461295|NCT00458952|E1|Reported Event|Ultratrace Iobenguane I 131|Each patient was to first receive an imaging dose of 5 mCi of Ultratrace iobenguane I 131 to confirm tumor uptake of the test article. If at least one tumor on a baseline CT/MRI scan was also visualized on the Ultratrace iobenguane I 131 scan, the patient was administered a therapeutic dose of Ultratrace iobenguane I 131. Dosing began at 6 mCi/kg for an initial cohort of 3 patients, and escalated in 1.0 mCi/kg increments until the MTD was established.
461296|NCT00458822|B1|Baseline|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
461297|NCT00458822|P1|Participant Flow|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
461298|NCT00458822|O1|Outcome|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
461299|NCT00458822|E1|Reported Event|All Patients|All patients treated with Melphalan with Stem Cell Transplant and Adjuvant Bortezomib and Dexamethasone for Recently Diagnosed Untreated Patients with Systemic Light-Chain (AL) Amyloidosis
461300|NCT00458705|B1|Baseline|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
461301|NCT00458705|P1|Participant Flow|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
461302|NCT00458705|O1|Outcome|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
461303|NCT00458705|E1|Reported Event|Combination Therapy|Combination therapy with bortezomib, pegylated liposomal doxorubicin and dexamethasone (BDD) followed by either thalidomide and dexamethasone (TD) or bortezomib, thalidomide and dexamethasone in patients with symptomatic untreated high-risk or primary resistant multiple myeloma. Three cycles of BDD will be administered. Patients who respond after three cycles will receive two cycles of TD. Patients with stable or progressive disease after three cycles of BDD receive two cycles of bortezomib, thalidomide and dexamethasone. If at any point during the study a patient achieves a complete response (CR), the patient will be given the option to discontinue treatment on-study.
461304|NCT00458536|B1|Baseline|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
461305|NCT00458536|P1|Participant Flow|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
461306|NCT00458536|O1|Outcome|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
461307|NCT00458536|E1|Reported Event|Patients Treated With Vaccine|Patients with renal cell carcinoma following debulking nephrectomy who receive at least 2 doses of DC/renal fusion vaccine.
461308|NCT00458406|B3|Baseline|Total|Total of all reporting groups
461309|NCT00458406|B2|Baseline|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461310|NCT00458406|B1|Baseline|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461311|NCT00458406|P2|Participant Flow|CPAP|"Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.~Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.~In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=13 were enrolled into the CPAP arm."
461312|NCT00458406|P1|Participant Flow|Bi-Flex|"Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study. Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy. In this randomized, double-blinded clinical trial, patients with obstructive sleep apnea were randomized Bi-Flex or CPAP, and a repeat polysomnography was performed on pressure at 3 months.~Of the N=56 assessed subjects, N=43 were enrolled into the Bi-Flex arm."
461313|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461314|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461315|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461316|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461317|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461318|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461319|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461320|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461321|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
461322|NCT00458406|O1|Outcome|BiFlex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
461323|NCT00458406|O2|Outcome|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461324|NCT00458406|O1|Outcome|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461325|NCT00458406|O2|Outcome|CPAP|Subjects in this arm underwent standard continuous positive airway pressure (CPAP) therapy.
461326|NCT00458406|O1|Outcome|Bi-Flex|Subjects in this arm underwent bilevel positive airway pressure with pressure release technology (Bi-Flex) therapy.
461327|NCT00458406|E2|Reported Event|CPAP|Subjects randomized to this arm will undergo a clinical CPAP titration sleep study.
461328|NCT00458406|E1|Reported Event|Bi-Flex|Subjects randomized to this arm will undergo a clinical Bi-Flex sleep study.
461329|NCT00458302|B3|Baseline|Total|Total of all reporting groups
461330|NCT00458302|B2|Baseline|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461331|NCT00458302|B1|Baseline|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461332|NCT00458302|P2|Participant Flow|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461333|NCT00458302|P1|Participant Flow|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461334|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461335|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461336|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461337|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461338|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461339|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461340|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461341|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461342|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461343|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461344|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461345|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461346|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461347|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461348|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461349|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461350|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461351|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461352|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461353|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461354|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461355|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461356|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461357|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461358|NCT00458302|O2|Outcome|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461359|NCT00458302|O1|Outcome|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461360|NCT00458302|E3|Reported Event|Total|
461361|NCT00458302|E2|Reported Event|DRV/r|800 mg qd (2 x 400 mg tablet) monotherapy for 144 weeks
461362|NCT00458302|E1|Reported Event|DRV/r+2NRTIs|800 mg qd (2 x 400 mg tablet) + 2 NRTI for 144 weeks
461363|NCT00458237|B4|Baseline|Total|Total of all reporting groups
461364|NCT00458237|B3|Baseline|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461365|NCT00458237|B2|Baseline|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461366|NCT00458237|B1|Baseline|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461367|NCT00458237|P3|Participant Flow|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461368|NCT00458237|P2|Participant Flow|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461369|NCT00458237|P1|Participant Flow|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461370|NCT00458237|O2|Outcome|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461371|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461372|NCT00458237|O2|Outcome|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461373|NCT00458237|O1|Outcome|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461374|NCT00458237|E3|Reported Event|Phase II: Everolimus (Maximum Tolerated Dose) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus at the MTD (10 mg) by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461375|NCT00458237|E2|Reported Event|Phase I: Everolimus (Dose Level 2) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 10 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461376|NCT00458237|E1|Reported Event|Phase I: Everolimus (Dose Level 1) and Trastuzumab|Cycle duration is 21 days. Participants receive trastuzumab 6 mg/kg [8 mg/kg loading dose] IV once every three weeks and take everolimus 5 mg by mouth daily on days 1-21. Participants are treated until disease progression or unacceptable toxicity.
461377|NCT00458211|B1|Baseline|Experimental|Open label change to ziprasidone
461378|NCT00458211|P1|Participant Flow|Experimental|Open label change to ziprasidone up to 120mg twice a day with meals
461379|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461380|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461381|NCT00458211|O1|Outcome|Experimental|All subjects, 17 at Buffalo and 19 at Bronx were given Ziprasidone.
461382|NCT00458211|O1|Outcome|Experimental|
461383|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461384|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461385|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461386|NCT00458211|O1|Outcome|Experimental|Open label change to ziprasidone
461387|NCT00458211|E1|Reported Event|Experimental|Open label change to ziprasidone
461388|NCT00457977|B3|Baseline|Total|Total of all reporting groups
461389|NCT00457977|B2|Baseline|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
461390|NCT00457977|B1|Baseline|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
461391|NCT00457977|P2|Participant Flow|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
461392|NCT00457977|P1|Participant Flow|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
461393|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
461394|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
461395|NCT00457977|O2|Outcome|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
461396|NCT00457977|O1|Outcome|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
461397|NCT00457977|E2|Reported Event|Prevnar (PCV7)|diphtheria protein-conjugated vaccine (PCV7) (Prevnar) 1.0 mL dose
461398|NCT00457977|E1|Reported Event|Pneumovax (PPSV23)|pneumococcal capsular polysaccharide vaccine (PPSV23) (Pneumovax)
461399|NCT00457951|B4|Baseline|Total|Total of all reporting groups
461400|NCT00457951|B3|Baseline|ODSH Treatment Group|ODSH Treatment Group Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
461401|NCT00457951|B2|Baseline|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride|Placebo Comparator: Placebo-Control: 0.9% Sodium Chloride Administered as bolus; then continuous administration over 96 hours in hospitalized subjects with exacerbations of COPD
461402|NCT00457951|B1|Baseline|Open-Label|Open-Label ODSH
461403|NCT00457951|P3|Participant Flow|ODSH Treatment Group|Double-blind randomized phase: The subjects receiving ODSH in the randomized portion of the study received 0.375 mg/kg/hr continuous IV infusion of ODSH for 96 hours.
461404|NCT00457951|P2|Participant Flow|Placebo Comparator: 0.9% Sodium Chloride|Double-blind randomized phase: Normal Saline infusion: Bolus infusion followed by a 4 day continuous infusion of placebo.
461405|NCT00457951|P1|Participant Flow|Open Label|"Open Label~The original protocol called for 304 subjects with exacerbation of COPD to be enrolled into the study. Thirteen patients with exacerbation of COPD were enrolled in the initial open label portion of the study. Of these thirteen subjects, the initial seven subjects were treated with an IV bolus of ODSH at 8 mg/kg followed by a continuous infusion of ODSH at 0.5 mg/kg/hr for 72 hours.~After an ad hoc safety committee assessed the safety of the data from the first seven subjects, six more subjects were treated concomitantly treated with ODSH and enoxaparin, a low molecular weight heparin commonly used for seriously ill hospitalized patients as DVT prophylaxis."
461406|NCT00457951|O2|Outcome|Randomized, Blinded, ODSH Arm|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
461407|NCT00457951|O1|Outcome|0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
461408|NCT00457951|E3|Reported Event|ODSH Treatment Group|"Subjects will receive standard of care treatment. ODSH is administered in bolus doses estimated to inhibit inflammatory mediators randomized 1:1 to ODSH 8mg/kg or placebo. The continuous infusion dose will be 0.375 mg/kg/hr over 96 hours.~ODSH: Randomized, Blinded, ODSH Arm"
461409|NCT00457951|E2|Reported Event|Placebo Comparator: 0.9% Sodium Chloride|"Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride Solution bolus; dose of 0.375mg/kg/hr over 96 hours.~Placebo Comparator: Placebo-Control Arm 0.9% Sodium Chloride: Placebo-Control Arm: Bolus infusion followed by a 96 hour continuous infusion of 0.9%Sodium Chloride"
461410|NCT00457951|E1|Reported Event|Open Label|"Initial six subjects treated with ODSH open-label to confirm safety in subjects with an acute exacerbation of COPD; six additional patients will be enrolled following safety review.~Open-Label: ODSH administered open-label"
461411|NCT00457821|B9|Baseline|Total|Total of all reporting groups
461415|NCT00457821|B5|Baseline|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
461416|NCT00457821|B4|Baseline|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
461417|NCT00457821|B3|Baseline|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
461418|NCT00457821|B2|Baseline|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
461419|NCT00457821|B1|Baseline|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
461420|NCT00457821|P8|Participant Flow|Part 2: Placebo|Part 2: placebo q12h; 28 days
461421|NCT00457821|P7|Participant Flow|Part 2: 250 mg|Part 2: Ivacaftor (250 mg) q12h; 28 days
461422|NCT00457821|P6|Participant Flow|Part 2: 150 mg|Part 2: Ivacaftor (150 mg) q12h; 28 days
461423|NCT00457821|P5|Participant Flow|Part 1: 150 mg/75 mg|Part 1: Ivacaftor (150 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
461424|NCT00457821|P4|Participant Flow|Part 1: 75 mg/150 mg|Part 1: Ivacaftor (75 mg/150 mg) every 12 hours (q12h); 14 days/14 days.
461425|NCT00457821|P3|Participant Flow|Part 1: 75 mg/25 mg|Part 1: Ivacaftor (75 mg/25 mg) every 12 hours (q12h); 14 days/14 days.
461426|NCT00457821|P2|Participant Flow|Part 1: 25 mg/75 mg|Part 1: Ivacaftor (25 mg/75 mg) every 12 hours (q12h); 14 days/14 days.
461427|NCT00457821|P1|Participant Flow|Part 1: Placebo|Part 1: placebo every 12 hours (q12h); 14 days/14 days.
461428|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
461429|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
461430|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
461431|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
461432|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
461433|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
461434|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
461435|NCT00457821|O3|Outcome|250 mg Ivacaftor q12h|Subjects given 250 mg of ivacaftor q12h for 28 days.
461436|NCT00457821|O2|Outcome|150 mg Ivacaftor q12h|Subjects given 150 mg of ivacaftor q12h for 28 days.
461437|NCT00457821|O1|Outcome|Placebo|Subjects given placebo every 12 hours (q12h) for 28 days.
461438|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
461439|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
461440|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
461441|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
461442|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
461443|NCT00457821|O5|Outcome|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
461444|NCT00457821|O4|Outcome|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
461445|NCT00457821|O3|Outcome|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
461446|NCT00457821|O2|Outcome|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
461447|NCT00457821|O1|Outcome|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
461448|NCT00457821|O2|Outcome|Ivacaftor|All subjects given Ivacaftor in Part 1 (n=16) and Part 2 (n=15)
461449|NCT00457821|O1|Outcome|Placebo|All subjects given placebo in Part 1 (n=4) and Part 2 (n=4)
461450|NCT00457821|E5|Reported Event|250 mg Ivacaftor q12h|All subjects given the 250 mg dose q12h in Group C (n=7) in Part 2.
461451|NCT00457821|E4|Reported Event|150 mg Ivacaftor q12h|All subjects given the 150 mg dose q12h in Group B in Part 1 (n=4 x 2) and Group C in Part 2 (n=8).
461452|NCT00457821|E3|Reported Event|75 mg Ivacaftor q12h|All subjects given the 75 mg dose q12h in Group A (n=4 x 2) and Group B (n=4 x 2) in Part 1.
461453|NCT00457821|E2|Reported Event|25 mg Ivacaftor q12h|All subjects given the 25 mg dose q12h in Group A in Part 1 (n=4 x 2).
461454|NCT00457821|E1|Reported Event|Placebo|All subjects given placebo every 12 hours (q12h) in Part 1 (n=4) and Part 2 (n=4)
461455|NCT00457795|B1|Baseline|Brimonidine 0.1%|Brimonidine 0.1%
461456|NCT00457795|P1|Participant Flow|Brimonidine 0.1%|Brimonidine 0.1%
461457|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
461458|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
461459|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
461460|NCT00457795|O1|Outcome|Brimonidine 0.1%|Brimonidine 0.1%
461461|NCT00457795|E1|Reported Event|Brimonidine 0.1%|Brimonidine 0.1%
461462|NCT00457743|B4|Baseline|Total|Total of all reporting groups
461463|NCT00457743|B3|Baseline|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461524|NCT00457691|B1|Baseline|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461464|NCT00457743|B2|Baseline|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461465|NCT00457743|B1|Baseline|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461466|NCT00457743|P3|Participant Flow|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461467|NCT00457743|P2|Participant Flow|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461468|NCT00457743|P1|Participant Flow|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461469|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461470|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461471|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461472|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461473|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461595|NCT00456521|O2|Outcome|Placebo|Placebo
461596|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461597|NCT00456521|O2|Outcome|Placebo|Placebo
461474|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461475|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461476|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461477|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461478|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461479|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461480|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461481|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461482|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461483|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461598|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461599|NCT00456521|O2|Outcome|Placebo|Placebo
461600|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461484|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461485|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461486|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461487|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461488|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461489|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461490|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461491|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461492|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461493|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461601|NCT00456521|E2|Reported Event|Placebo|Placebo
461602|NCT00456521|E1|Reported Event|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461494|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461495|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461496|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461497|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461498|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461499|NCT00457743|O1|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461500|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461501|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461502|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461503|NCT00457743|O3|Outcome|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461603|NCT00456508|B1|Baseline|Treatment|DX-88 (ecallantide)
461707|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461504|NCT00457743|O2|Outcome|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461505|NCT00457743|O1|Outcome|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461506|NCT00457743|E3|Reported Event|SU-011248 75-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 75-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be reduced to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461507|NCT00457743|E2|Reported Event|SU-011248 50-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 50-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria.~From Phase 1 part of this study, 50-mg was determined as the maximum tolerated dose and the recommended dose."
461508|NCT00457743|E1|Reported Event|SU-011248 25-mg|"Subjects received sunitinib malate (SU-011248) at starting dose of 25-mg once daily. Treatment cycles were 6 weeks in duration, consisting of 4 weeks daily SU-011248 administration followed by 2 weeks off treatment.~Phase 1: If Dose Limiting Toxicity (DLT) was observed, the patients were withdrawn from the study treatment. Neither temporary discontinuation nor reduction was permitted.~Phase 2: The initial dose could be increased to the recommended dose. Treatment cycles were repeated until a study treatment withdrawal criterion was met. If drug-related adverse event (grade>=3) was observed, temporary discontinuation or dose reduction were taken according to the criteria."
461509|NCT00457730|B3|Baseline|Total|Total of all reporting groups
461510|NCT00457730|B2|Baseline|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
461511|NCT00457730|B1|Baseline|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
461512|NCT00457730|P2|Participant Flow|Placebo|subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.
461513|NCT00457730|P1|Participant Flow|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
461514|NCT00457730|O2|Outcome|Placebo|matched placebo medication with same periods
461515|NCT00457730|O1|Outcome|Duloxetine|Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week
461516|NCT00457730|O2|Outcome|Placebo|matched placebo medication throughout 6 week observation period
461517|NCT00457730|O1|Outcome|Duloxetine|ubjects will take 30 mg daily for 1 week, then 60 mg daily for 5 weeks, then titrate back down to 30 mg daily for 1 week.
461518|NCT00457730|O2|Outcome|Placebo|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
461519|NCT00457730|O1|Outcome|Duloxetine|"subjects will be randomized to study drug (Duloxetine) or Placebo. Subjects will take 30 mg (10 capsules) titrate up to 60 mg( 40 capsules) and titrate back down to 30 mg.~Placebo: Patients will be randomly assigned to Duloxetine 30mg/d for 1 week, 60mg/d for 5 weeks and 30mg/d for 1 week or placebo for 7 weeks under double-blind conditions.~Placebo: Subjects are randomized to either Duloxetine or Placebo"
461520|NCT00457730|E2|Reported Event|Placebo|Placebo: Matching placebo drug for 7 weeks total
461521|NCT00457730|E1|Reported Event|Duloxetine|Study drug, Duloxetine, 30 mg for 1 week, titrate up to 60 mg for 5 weeks and titrate back down to 30 mg for 1 week.
461522|NCT00457691|B3|Baseline|Total|Total of all reporting groups
461523|NCT00457691|B2|Baseline|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461525|NCT00457691|P2|Participant Flow|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461526|NCT00457691|P1|Participant Flow|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461527|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461528|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461529|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461530|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461531|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461532|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461533|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461534|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461535|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461536|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461537|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461538|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461539|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461540|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461678|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461541|NCT00457691|O2|Outcome|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461542|NCT00457691|O1|Outcome|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461543|NCT00457691|E2|Reported Event|FOLFIRI + Placebo|IV irinotecan (180 mg/m²), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-FU IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Placebo oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week placebo cycle.
461544|NCT00457691|E1|Reported Event|FOLFIRI + Sunitinib|Intravenous (IV) irinotecan (180 milligrams per square meter [mg/m²]), and levo-leucovorin (200 mg/m² or leucovorin at 400 mg/m²) immediately followed by 5-fluorouracil (5-FU) IV bolus (400 mg/m²) and 5-FU 46-hour continuous IV infusion (2400 mg/m²) every 2 weeks (FOLFIRI). Sunitinib 37.5 mg oral capsules once daily on Schedule 4/2 (4 weeks on, 2 weeks off). Three courses of FOLFIRI were administered during every 6 week sunitinib cycle.
461545|NCT00456547|B3|Baseline|Total|Total of all reporting groups
461546|NCT00456547|B2|Baseline|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461547|NCT00456547|B1|Baseline|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461548|NCT00456547|P2|Participant Flow|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461549|NCT00456547|P1|Participant Flow|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461550|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461551|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461552|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461553|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461554|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461555|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461556|NCT00456547|O2|Outcome|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461557|NCT00456547|O1|Outcome|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461558|NCT00456547|E2|Reported Event|Cesarean Delivery Case Controls|Women that deliver by cesarean that presented with risk factors for bleeding but did not require post delivery hysterectomy
461559|NCT00456547|E1|Reported Event|Postpartum Hysterectomy|Women that require postpartum hysterectomy for post-delivery bleeding.
461560|NCT00456521|B3|Baseline|Total|Total of all reporting groups
461561|NCT00456521|B2|Baseline|Placebo|Placebo
461562|NCT00456521|B1|Baseline|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461563|NCT00456521|P2|Participant Flow|Placebo|Placebo
461564|NCT00456521|P1|Participant Flow|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461565|NCT00456521|O2|Outcome|Placebo|Placebo
461566|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461567|NCT00456521|O2|Outcome|Placebo|Placebo
461568|NCT00456521|O1|Outcome|NB32|"Naltrexone SR 32 mg/ bupropion SR 360 mg/ day with intensive group behavioral lifestyle modification counseling~naltrexone SR/bupropion SR combination~Intensive group lifestyle modification counseling: Group lifestyle modification counseling"
461569|NCT00456521|O2|Outcome|Placebo|Placebo
461570|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461571|NCT00456521|O2|Outcome|Placebo|Placebo
461572|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461573|NCT00456521|O2|Outcome|Placebo|Placebo
461574|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461575|NCT00456521|O2|Outcome|Placebo|Placebo
461576|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461577|NCT00456521|O2|Outcome|Placebo|Placebo
461578|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461579|NCT00456521|O2|Outcome|Placebo|Placebo
461580|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461581|NCT00456521|O2|Outcome|Placebo|Placebo
461582|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461583|NCT00456521|O2|Outcome|Placebo|Placebo
461584|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461585|NCT00456521|O2|Outcome|Placebo|Placebo
461586|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461587|NCT00456521|O2|Outcome|Placebo|Placebo
461588|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461589|NCT00456521|O2|Outcome|Placebo|Placebo
461590|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461591|NCT00456521|O2|Outcome|Placebo|Placebo
461592|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461593|NCT00456521|O2|Outcome|Placebo|Placebo
461594|NCT00456521|O1|Outcome|NB32|Naltrexone SR 32 mg/ bupropion SR 360 mg/ day
461604|NCT00456508|P1|Participant Flow|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
461605|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
461606|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
461607|NCT00456508|O1|Outcome|DX-88 (Ecallantide)|Patients were treated with DX-88 (ecallantide) when they experienced an HAE attack. 30 mg dose of ecallantide given via 3 SC injections; a second 30 mg dose can be administered if needed. Patients were to be assessed until 4 hrs post-dose. Patients were asked to return for 3 follow-up visits: 7 days, 28 days and 90 days post-dose.
461608|NCT00456508|E1|Reported Event|Treatment|DX-88 (ecallantide)
461609|NCT00456495|B1|Baseline|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
461610|NCT00456495|P1|Participant Flow|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
461611|NCT00456495|O1|Outcome|Open Label Treatment|Patients will receive treatment every 2-4 weeks
461612|NCT00456495|E1|Reported Event|Squamous Carcinoma of Conjunctiva|Subconjunctival 0.5 mg ranibizumab
461613|NCT00457418|B1|Baseline|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461614|NCT00457418|P1|Participant Flow|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461615|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461616|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461617|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461618|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461619|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461620|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461621|NCT00457418|O1|Outcome|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461622|NCT00457418|E1|Reported Event|PEG-Intron|"6 ug/kg/week, SC (first 8 weeks)~3 ug/kg/week, SC (252 weeks [weeks 9-260], maintenance)"
461623|NCT00457392|B3|Baseline|Total|Total of all reporting groups
461624|NCT00457392|B2|Baseline|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461625|NCT00457392|B1|Baseline|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461626|NCT00457392|P2|Participant Flow|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461627|NCT00457392|P1|Participant Flow|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461628|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461629|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461630|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461631|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461632|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461633|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461634|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461635|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461636|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461637|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461638|NCT00457392|O2|Outcome|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461639|NCT00457392|O1|Outcome|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461640|NCT00457392|E2|Reported Event|Erlotinib|Placebo capsule matched to sunitinib administered orally daily (continuous regimen) in a 4 week cycle. Erlotinib 150 mg tablet orally daily.
461706|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461641|NCT00457392|E1|Reported Event|Sunitinib + Erlotinib|Sunitinib capsule administered orally at a dose of 37.5 milligram (mg) daily (continuous regimen) in a 4 week cycle. Erlotinib administered orally at a dose of 150 mg daily.
461642|NCT00457301|B3|Baseline|Total|Total of all reporting groups
461643|NCT00457301|B2|Baseline|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461644|NCT00457301|B1|Baseline|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461645|NCT00457301|P2|Participant Flow|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461646|NCT00457301|P1|Participant Flow|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461647|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461648|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461649|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461650|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461651|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461652|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461653|NCT00457301|O2|Outcome|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461654|NCT00457301|O1|Outcome|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461655|NCT00457301|E2|Reported Event|HUI2 and HUI3 Completion and Feedback to Clinicians|Patients in the intervention arm completed the HUI2 and HUI3 and results were fedback to clinicians before the encounter with the patient at every clinic visit.
461656|NCT00457301|E1|Reported Event|HUI2 and HUI3 Completion Without Feedback to Clinicians.|Patients in the control arm completed the HUI2 and HUI3 but the results were not fed back to clinicians.
461657|NCT00457249|B3|Baseline|Total|Total of all reporting groups
461658|NCT00457249|B2|Baseline|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461659|NCT00457249|B1|Baseline|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461660|NCT00457249|P2|Participant Flow|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
461661|NCT00457249|P1|Participant Flow|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461662|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461663|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461664|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461665|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461666|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of DECAVAC® vaccine.
461667|NCT00457249|O1|Outcome|Adacel® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461668|NCT00457249|O2|Outcome|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461669|NCT00457249|O1|Outcome|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461670|NCT00457249|E2|Reported Event|DECAVAC® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461671|NCT00457249|E1|Reported Event|ADACEL® Vaccine Group|Participants received a single dose of ADACEL® vaccine.
461672|NCT00457197|B3|Baseline|Total|Total of all reporting groups
461673|NCT00457197|B2|Baseline|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461674|NCT00457197|B1|Baseline|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461675|NCT00457197|P2|Participant Flow|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461676|NCT00457197|P1|Participant Flow|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461677|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461679|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461680|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461681|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461682|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461683|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461684|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461685|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461686|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461687|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461688|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461689|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461690|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461691|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461692|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461693|NCT00457197|O2|Outcome|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461694|NCT00457197|O1|Outcome|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461695|NCT00457197|E2|Reported Event|Quetiapine|"This group will be given 50mg Quetiapine per day baseline-week 1, 100mg Quetiapine per day week 1-week 2, 200mg Quetiapine per day week 2-week 3, 400mg Quetiapine per day week 3-week 4, and 600mg Quetiapine per day week 4 to week 12.~Quetiapine: Quetiapine is an atypical antipsychotic approved for the treatment of schizophrenia, bipolar disorder, and in the XR version along with an SSRI to treat major depressive disorder."
461696|NCT00457197|E1|Reported Event|Placebo|"This group will be given placebo matching quetiapine for the course of the 12 weeks in the study.~Placebo: Inactive ingredient matching the active medication in appearance."
461697|NCT00457015|B3|Baseline|Total|Total of all reporting groups
461698|NCT00457015|B2|Baseline|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461699|NCT00457015|B1|Baseline|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461700|NCT00457015|P2|Participant Flow|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461701|NCT00457015|P1|Participant Flow|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461702|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461703|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461704|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461705|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461708|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461709|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461710|NCT00457015|O2|Outcome|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461711|NCT00457015|O1|Outcome|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461712|NCT00457015|E2|Reported Event|Placebo|Placebo, Phosphate Buffer Saline (PBS), pH 7.0 given as 3 subcutaneous injections.
461713|NCT00457015|E1|Reported Event|KALBITOR (Ecallantide)|KALBITOR (ecallantide, DX-88) 30 mg given as three 10 mg/mL subcutaneous injections.
461714|NCT00457002|B3|Baseline|Total|Total of all reporting groups
461715|NCT00457002|B2|Baseline|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461716|NCT00457002|B1|Baseline|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461717|NCT00457002|P2|Participant Flow|Enoxaparin 40 mg Subcutaneous|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461718|NCT00457002|P1|Participant Flow|Apixaban 2.5 mg Oral|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461719|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461720|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461721|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461722|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461723|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461724|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461725|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461726|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461727|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461728|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461729|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461730|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461731|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461732|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461733|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461734|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461735|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461736|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461737|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461738|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461739|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461740|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461741|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461742|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461743|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461879|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461744|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461745|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461746|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461747|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461748|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461749|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461750|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461751|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461752|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461753|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461754|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461755|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461756|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461757|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461758|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461759|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461760|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461761|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461762|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461763|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461764|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461765|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461766|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461767|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461768|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461769|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461770|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461771|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461772|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461773|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461774|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461775|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461776|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461777|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
463646|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
461778|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461779|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461780|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461781|NCT00457002|O2|Outcome|Enoxaparin 40 mg|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461782|NCT00457002|O1|Outcome|Apixaban 2.5 mg|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461783|NCT00457002|E2|Reported Event|Enox 40mg QD|Subcutaneous (SC) administration of 40 mg enoxaparin once daily (QD) for a minimum of 6 days plus placebo tablets matching apixaban 2.5 mg for 30 days.
461784|NCT00457002|E1|Reported Event|Apix 2.5mg BID|Oral administration of 2.5 mg apixaban tablets twice daily (BID) for 30 days plus placebo matching enoxaparin 40 mg QD while in hospital and for a minimum of 6 days.
461785|NCT00456989|B1|Baseline|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
461786|NCT00456989|P1|Participant Flow|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
461787|NCT00456989|O1|Outcome|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
461788|NCT00456989|E1|Reported Event|Taxotere and Doxil|"Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively. Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively.~Taxotere: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Taxotere is administered on days 1, 8 and 15 (rate: 1 hour). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 25 and 30, respectively.~Doxil: Treatment will be administered on an outpatient basis. Treatment will be repeated every 28 days. Doxil is administered on day 1 (rate: 1mg/min). Dose levels 1, 2 and 3 (mg/m2 i.v.) are 25, 30 and 30, respectively."
461789|NCT00456846|B3|Baseline|Total|Total of all reporting groups
461790|NCT00456846|B2|Baseline|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461791|NCT00456846|B1|Baseline|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461792|NCT00456846|P2|Participant Flow|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
461793|NCT00456846|P1|Participant Flow|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest. Therapy continued until disease progression or unacceptable toxicity.
461794|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461795|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461796|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461797|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
463647|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
461798|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461799|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461800|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461801|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461802|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461803|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461804|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461805|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461806|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461807|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461808|NCT00456846|O2|Outcome|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461809|NCT00456846|O1|Outcome|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461810|NCT00456846|E2|Reported Event|Abraxane (No Prior Taxane Therapy)|Participants who had not received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461811|NCT00456846|E1|Reported Event|Abraxane (Prior Taxane Therapy)|Participants who had received a taxane as part of their adjuvant therapy received Abraxane (ABI-007) at 100 mg/m^2 given intravenously (IV) over 30 minutes weekly for 3 weeks followed by 1 week rest
461812|NCT00456807|B3|Baseline|Total|Total of all reporting groups
461813|NCT00456807|B2|Baseline|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461814|NCT00456807|B1|Baseline|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461815|NCT00456807|P2|Participant Flow|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461816|NCT00456807|P1|Participant Flow|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461817|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461818|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461819|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461820|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461821|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461822|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461823|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461824|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461825|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461826|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461827|NCT00456807|O2|Outcome|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461828|NCT00456807|O1|Outcome|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461829|NCT00456807|E2|Reported Event|Placebo Group|Subjects who received 3 doses of placebo during the primary study (NCT00294047).
461830|NCT00456807|E1|Reported Event|Cervarix Group|Subjects who received 3 doses of Cervarix during the primary study (NCT00294047).
461831|NCT00456755|B3|Baseline|Total|Total of all reporting groups
461832|NCT00456755|B2|Baseline|Placebo|The placebo contained brown colored starch resembling the SBL powder
461833|NCT00456755|B1|Baseline|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
461834|NCT00456755|P2|Participant Flow|Placebo|The placebo contained brown colored starch resembling the SBL powder
461880|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461835|NCT00456755|P1|Participant Flow|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
461836|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
461837|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
461838|NCT00456755|O2|Outcome|Placebo|The placebo contained brown colored starch resembling the SBL powder
461839|NCT00456755|O1|Outcome|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
461840|NCT00456755|E2|Reported Event|Placebo|The placebo contained brown colored starch resembling the SBL powder
461841|NCT00456755|E1|Reported Event|Shi-Bi-Lin|Consist of 6 herbal. 7.5 g Xanthium sibiricum Patrin ex Widder (Asteraceae, Fructus), 20 g Angelica dahurica (Fisch. ex Hoffm.) Benth. (Apiaceae, Radix), 7.5 g Saposhnikovia divaricata (Turcz.) Schischk. (Apiaceae, Radix),15 g Magnolia biondii Pamp., (Magnoliaceae, Flos), 5 g Gentiana scabra Bunge (Gentianaceae, Radix) and 5 g Verbena officinalis L. (Verbenaceae, Herba).
461842|NCT00456625|B1|Baseline|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461843|NCT00456625|P1|Participant Flow|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461844|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461845|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461846|NCT00456625|O1|Outcome|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461847|NCT00456625|E1|Reported Event|Group Engerix™-B|Subjects received a dose of Hepatitis B vaccine approximately 20 years after the primary neonatal vaccination
461848|NCT00456612|B1|Baseline|Single Arm|Single arm Phase II Study
461849|NCT00456612|P1|Participant Flow|Cyberknife|Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.
461850|NCT00456612|O1|Outcome|Single Arm|Single arm Phase II Study
461851|NCT00456612|O1|Outcome|Cyberknife|"Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses.~CyberKnife: Radiosurgery to enhancing high grade glioma in 5 fractions with escalating doses."
461852|NCT00456612|E1|Reported Event|Single Arm Study|Single arm Phase II Study
461853|NCT00456599|B1|Baseline|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
461854|NCT00456599|P1|Participant Flow|Gemcitabine and Oxaliplatin With Radiation Therapy|Gemcitabine and Oxaliplatin with radiation therapy in localized pancreatic cancer.
461855|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
461856|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
461857|NCT00456599|O1|Outcome|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
461858|NCT00456599|E1|Reported Event|Oxaliplatin & Gemcitabine With Radiation|Protocol treatment consisted of four 28 day cycles of chemotherapy: 2 cycles before surgery and 2 cycles before surgery and 2 cycles after. Gemcitabine (1 g/m2 infused over 30 minutes) was administered on days 1, 8, and 15 of each cycle; oxaliplatin (85 mg/m2 infused over 90 minutes) was administered on days 1 and 15. Radiation therapy was delivered concurrently with the first cycle of chemotherapy in 2-Gray [Gy] fractions (total dose, 30 Gy).
461859|NCT00456261|B3|Baseline|Total|Total of all reporting groups
461860|NCT00456261|B2|Baseline|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461881|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461882|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461861|NCT00456261|B1|Baseline|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461862|NCT00456261|P2|Participant Flow|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461863|NCT00456261|P1|Participant Flow|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461864|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461865|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461866|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461867|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461868|NCT00456261|O2|Outcome|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461869|NCT00456261|O1|Outcome|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461870|NCT00456261|E2|Reported Event|Bevacizumab/Pemetrexed/Carboplatin|Cohort B, will receive bevacizumab 15mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over approximately 10 minutes followed by carboplatin AUC=5 by vein over 30-60 minutes. This regimen will be given on day 1 of each treatment cycle. Each cycle is 21 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 3 weeks as long as their disease does not worsen.
461871|NCT00456261|E1|Reported Event|Bevacizumab/Pemetrexed/Gemcitabine|Cohort A, will receive bevacizumab 10mg/kg by vein over 30-90 minutes followed by pemetrexed 500 mg/m2 by vein over 10 minutes followed by gemcitabine 1500 mg/m2 by vein over 30-60 minutes. This regimen will be given on day 1 and day 15 of each treatment cycle. Each cycle is 28 days long. As long as their disease does not worsen patients can receive up to a maximum of 6 cycles of this combination chemotherapy. Following that they can receive bevacizumab alone once every 2 weeks as long as their disease does not worsen.
461872|NCT00455975|B3|Baseline|Total|Total of all reporting groups
461873|NCT00455975|B2|Baseline|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461874|NCT00455975|B1|Baseline|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461875|NCT00455975|P2|Participant Flow|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461876|NCT00455975|P1|Participant Flow|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461877|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461878|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461977|NCT00455533|E2|Reported Event|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461883|NCT00455975|O2|Outcome|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461884|NCT00455975|O1|Outcome|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461885|NCT00455975|E2|Reported Event|Bi-weekly Avastin|"Bevacizumab 15mg/kg IV every 2 weeks until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461886|NCT00455975|E1|Reported Event|Weekly Avastin|"Bevacizumab 15mg/kg IV weekly until progressive disease or toxicity~Bevacizumab: Bevacizumab"
461887|NCT00455858|B1|Baseline|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461888|NCT00455858|P1|Participant Flow|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461889|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461890|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461891|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461892|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461893|NCT00455858|O1|Outcome|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461894|NCT00455858|E1|Reported Event|Insulin Detemir|Insulin detemir start dose of 0.2 U/kg body weight added to Subject's ongoing OAD (oral anti-diabetic drug) monotherapy or combination therapy of 2 or more OADs. Insulin detemir treatment is titrated based on subject's self-monitored plasma glucose.
461895|NCT00455702|B3|Baseline|Total|Total of all reporting groups
461896|NCT00455702|B2|Baseline|Placebo|50 mg placebo
461897|NCT00455702|B1|Baseline|D-cycloserine|50 mg d-cycloserine
461898|NCT00455702|P2|Participant Flow|Placebo|50 mg placebo
461899|NCT00455702|P1|Participant Flow|D-cycloserine|50 mg d-cycloserine
461900|NCT00455702|O2|Outcome|Placebo|"50 mg placebo~d-cycloserine: 50mg dose d-cycloserine v placebo"
461901|NCT00455702|O1|Outcome|D-cycloserine|"50 mg d-cycloserine~d-cycloserine: 50mg dose d-cycloserine v placebo"
461902|NCT00455702|O2|Outcome|Placebo|50 mg placebo
461903|NCT00455702|O1|Outcome|D-cycloserine|50 mg d-cycloserine
461904|NCT00455702|E2|Reported Event|Placebo|50 mg placebo
461905|NCT00455702|E1|Reported Event|D-cycloserine|50 mg d-cycloserine
461906|NCT00455663|B4|Baseline|Total|Total of all reporting groups
461907|NCT00455663|B3|Baseline|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
461908|NCT00455663|B2|Baseline|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
461909|NCT00455663|B1|Baseline|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
461910|NCT00455663|P3|Participant Flow|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
461911|NCT00455663|P2|Participant Flow|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
461912|NCT00455663|P1|Participant Flow|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
461913|NCT00455663|O3|Outcome|Treatment as Usual|Medication management and case management at a community mental health center
461914|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
461915|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
461916|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
461917|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
461918|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
461919|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management at a community mental health center
461920|NCT00455663|O2|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports for medication and appointment adherence
461921|NCT00455663|O1|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
461922|NCT00455663|O3|Outcome|Treatment as Usual|medication management and case management in the community mental health center
461923|NCT00455663|O2|Outcome|Cognitive Adaptation Training|Environmental supports for all independent living skills
461924|NCT00455663|O1|Outcome|Pharm-Cognitive Adaptation Training|Environmental supports to assist in medication and appointment adherence
461925|NCT00455663|E3|Reported Event|Treatment As Usual|Medication follow up and limited case management provided by local mental health authority
461926|NCT00455663|E2|Reported Event|Pharm-Cognitive Adaptation Training|Uses Supports from Cognitive Adaptation Training designed only to promote adherence to medication and treatment follow up.
461927|NCT00455663|E1|Reported Event|Cognitive Adaptation Training|In home treatment using environmental supports such as signs, labels, alarms, checklists and the organization of belongings to bypass cognitive impairment, cue and sequence adaptive behavior and improve a wide range of functional outcomes.
461928|NCT00455533|B3|Baseline|Total|Total of all reporting groups
461929|NCT00455533|B2|Baseline|Paclitaxel (Randomized Population)|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461930|NCT00455533|B1|Baseline|Ixabepilone (Randomized Population)|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461931|NCT00455533|P3|Participant Flow|Paclitaxel|Paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461932|NCT00455533|P2|Participant Flow|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461933|NCT00455533|P1|Participant Flow|Doxorubicin / Cyclophosphamide (AC)|60 mg/m^2 doxorubicin and 600 mg/m^2 cyclophosphamide (AC) every 3 weeks for 4 cycles (12 weeks).
461934|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461935|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461936|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461937|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461938|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461939|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461940|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461941|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461942|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461943|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461944|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461945|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461946|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461947|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461948|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461949|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461950|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461951|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461952|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461953|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461954|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461955|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461956|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461957|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461958|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461959|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461960|NCT00455533|O1|Outcome|Randomized Participants|Randomized Participants with non-missing pCR and biomarker expression
461961|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461962|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461963|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461964|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461965|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461966|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461967|NCT00455533|O1|Outcome|Randomized Participants|
461968|NCT00455533|O1|Outcome|Randomized Participants|
461969|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461970|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461971|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461972|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461973|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461974|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461975|NCT00455533|O2|Outcome|Paclitaxel|paclitaxel 80 mg/m^2 administered IV every week for 12 weeks
461976|NCT00455533|O1|Outcome|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461978|NCT00455533|E1|Reported Event|Ixabepilone|ixabepilone 40 mg/m^2 administered intravenously (IV) over 3 hours, every 3 weeks for 4 cycles (12 weeks)
461979|NCT00455520|B3|Baseline|Total|Total of all reporting groups
461980|NCT00455520|B2|Baseline|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461981|NCT00455520|B1|Baseline|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461982|NCT00455520|P2|Participant Flow|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461983|NCT00455520|P1|Participant Flow|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461984|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461985|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461986|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461987|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461988|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461989|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461990|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461991|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461992|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461993|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461994|NCT00455520|O2|Outcome|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461995|NCT00455520|O1|Outcome|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461996|NCT00455520|E2|Reported Event|Placebo|Placebo tablets taken orally twice a day (BID) for 12 weeks during the double blind period.
461997|NCT00455520|E1|Reported Event|Tapentadol ER|Tapentadol ER dose of 100 to 250mg twice a day (BID) for 12 weeks during the double blind period. The study medication was provided as tablets taken orally.
461998|NCT00455455|B1|Baseline|Entire Study Group|includes groups randomized to use RepleniSH in the 1st period and ReNu in the 2nd period, and first use ReNu and use RepleniSH in the second period.
461999|NCT00455455|P2|Participant Flow|ReNu First, Then RepleniSH|Following a washout period, use ReNu for lens care in first period and RepleniSH in second period (after the second washout period)
462000|NCT00455455|P1|Participant Flow|RepleniSH First, Then ReNu|Following a washout period, use RepleniSH for lens care in first period and ReNu in second period (after the second washout period)
462001|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in the first period or the second period
462002|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in the first period and the second period
462003|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
462004|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
462005|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
462006|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
462007|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
462008|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
462009|NCT00455455|O2|Outcome|ReNu|use ReNu for lens care in either first period or second period
462010|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
462011|NCT00455455|O2|Outcome|ReNu|Use ReNu for lens care in either first period or second period
462012|NCT00455455|O1|Outcome|RepleniSH|use RepleniSH for lens care in either first period or second period
462013|NCT00455455|E2|Reported Event|ReNu|use ReNu for lens care in either first period or second period
462014|NCT00455455|E1|Reported Event|RepleniSH|use RepleniSH for lens care in either first period or second period
462015|NCT00455429|B5|Baseline|Total|Total of all reporting groups
462016|NCT00455429|B4|Baseline|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462017|NCT00455429|B3|Baseline|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462018|NCT00455429|B2|Baseline|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462019|NCT00455429|B1|Baseline|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462020|NCT00455429|P4|Participant Flow|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462021|NCT00455429|P3|Participant Flow|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462022|NCT00455429|P2|Participant Flow|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462023|NCT00455429|P1|Participant Flow|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462024|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
463648|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
462025|NCT00455429|O2|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462026|NCT00455429|O1|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462027|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462028|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462029|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462030|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462031|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462032|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462033|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462034|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462035|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462036|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462037|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462038|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462039|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462040|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462041|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462042|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462043|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462044|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462045|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462046|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462047|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462048|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462049|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462050|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462051|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462052|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462053|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462054|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462055|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462056|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462057|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462058|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462059|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462060|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462061|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462062|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462063|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462064|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462065|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462066|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462067|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462068|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462069|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462070|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462071|NCT00455429|O4|Outcome|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462072|NCT00455429|O3|Outcome|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462073|NCT00455429|O2|Outcome|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462074|NCT00455429|O1|Outcome|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462075|NCT00455429|E4|Reported Event|JNJ-26113100 (100 mg) Twice Daily|JNJ-26113100 (100 mg) capsules orally twice daily for 6 weeks.
462076|NCT00455429|E3|Reported Event|JNJ-26113100 (100 mg) Once Daily|JNJ-26113100 (100 mg) capsules orally once daily for 6 weeks.
462077|NCT00455429|E2|Reported Event|JNJ-26113100 (50 mg) Once Daily|JNJ-26113100 (50 mg) capsules orally once daily for 6 weeks.
462078|NCT00455429|E1|Reported Event|Placebo|Matching placebo capsules to JNJ-26113100 (50 milligram [mg]) orally once daily or 100 mg orally once daily or 100 mg orally twice daily for 6 weeks.
462079|NCT00455195|B3|Baseline|Total|Total of all reporting groups
462080|NCT00455195|B2|Baseline|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
462081|NCT00455195|B1|Baseline|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462082|NCT00455195|P2|Participant Flow|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600), completed the double-blind study, and started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
462083|NCT00455195|P1|Participant Flow|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462084|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462085|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462086|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462087|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462088|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462089|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462090|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462091|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462092|NCT00455195|O1|Outcome|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462093|NCT00455195|E3|Reported Event|Overall|The combined alglucosidase alfa treatment experience from the two treatment groups.
462094|NCT00455195|E2|Reported Event|Placebo/Alglucosidase Alfa|Participants who received placebo during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double-blind study, started alglucosidase alfa in the extension study. Only participants' experience on alglucosidase alfa in the extension study is represented.
462095|NCT00455195|E1|Reported Event|Alglucosidase Alfa/Alglucosidase Alfa|Participants who received alglucosidase alfa during the double-blind study AGLU02704 (NCT00158600) and, if they completed the double blind study, continued alglucosidase alfa in the extension study. Both study experiences on alglucosidase alfa are represented within AGLU03206.
462096|NCT00455013|B4|Baseline|Total|Total of all reporting groups
462097|NCT00455013|B3|Baseline|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462112|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462373|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462374|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462098|NCT00455013|B2|Baseline|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462099|NCT00455013|B1|Baseline|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462100|NCT00455013|P3|Participant Flow|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF 1g BID. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1, 2, 3, 4 up to maximum dose of 6 mg/kg.
462101|NCT00455013|P2|Participant Flow|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 nanograms per milliliter (ng/mL) for first 6 months, followed by 5 - 10 ng/mL until 12 months. Participants were allowed to switch from sirolimus to MMF. Background immunosuppressive medications: methylprednisolone was administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4, up to maximum dose of 6 mg/kg.
462102|NCT00455013|P1|Participant Flow|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; intravenous infusion (IV) belatacept: 10 milligram per kilogram of weight (mg/kg) Day 1 (day of transplant) and Day 5, then every other week through Month 3 (Weeks 2,4,6,8,10,12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until 12 months; MMF (mycophenolate mofetil) 1g twice daily(BID). Participants were allowed to switch from MMF to sirolimus. Background immunosuppressive medications: methylprednisolone administered as 500, 250, 125, and 60 mg IV on Days 1, 2, 3, 4; thymoglobulin 1.5 mg/kg IV infusion on Days 1 (day of transplant), 2, 3, 4, up to maximum dose of 6 mg/kg.
462103|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462104|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462105|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462106|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462107|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462108|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462109|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462110|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462111|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462113|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462114|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462115|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462116|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462117|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462118|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462119|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462120|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462121|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462122|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462123|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462124|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462125|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462126|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462127|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462181|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462128|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462129|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462130|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462131|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462132|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462133|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462134|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462135|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462136|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462137|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462138|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462139|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462140|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462141|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462142|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462182|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462143|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462144|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462145|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462146|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462147|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462148|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462149|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462150|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462151|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462152|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462153|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462154|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462155|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462156|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462157|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462183|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462158|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462159|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462160|NCT00455013|O3|Outcome|Tacrolimus, MMF|Comparator regimen: thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; oral tacrolimus 0.1 mg/kg/day in 2 divided doses with initial targeted trough level of 8-12 ng/mL for Days 1 - 30 with dose reduction to achieve 12 hour trough target of 5-10 ng/mL for 12 months; MMF (mycophenolate mofetil) 1g BID.
462161|NCT00455013|O2|Outcome|Belatacept, Sirolimus|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24),after 6 months, 5 mg/kg every 4 weeks until Month 12; sirolimus 5 mg/day on Day 1 and continued through Day 2, dosing to be adjusted to keep pre-dose C0 (concentration at time zero after administration) levels at 7-12 ng/mL for first 6 months, followed by 5 - 10 ng/mL until Month 12. Participants were allowed to switch from sirolimus to MMF.
462162|NCT00455013|O1|Outcome|Belatacept, Mycophenolate Mofetil (MMF)|Thymoglobulin 1.5mg/kg for 4 days plus 4 corresponding doses of corticosteroids; IV belatacept: 10 mg/kg Days 1 and 5, then every other week through Month 3 (Weeks 2, 4, 6, 8, 10, 12), and then every 4 weeks through Month 6 (Weeks 16, 20, 24), after 6 months, 5 mg/kg every 4 weeks until Month 12; MMF 1g BID. Participants were allowed to switch from MMF to sirolimus.
462163|NCT00455013|E3|Reported Event|Tacrolimus - MMF|
462164|NCT00455013|E2|Reported Event|Belatacept - SIRO|
462165|NCT00455013|E1|Reported Event|Belatacept - MMF|
462166|NCT00454987|B4|Baseline|Total|Total of all reporting groups
462167|NCT00454987|B3|Baseline|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462168|NCT00454987|B2|Baseline|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462169|NCT00454987|B1|Baseline|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462170|NCT00454987|P3|Participant Flow|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462171|NCT00454987|P2|Participant Flow|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462172|NCT00454987|P1|Participant Flow|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462173|NCT00454987|O3|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462174|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462175|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462176|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462177|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462178|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462179|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462180|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462184|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462185|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462186|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462187|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462188|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462189|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462190|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462191|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462192|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462193|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462194|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462195|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462196|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462197|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462198|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462199|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462200|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462201|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462202|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462203|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462204|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462205|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462206|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462207|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462208|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462209|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462210|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462211|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462212|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462213|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462214|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462215|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462216|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462217|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462218|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462219|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462220|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462221|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462222|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462223|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462224|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462225|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462226|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462227|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462228|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462229|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462263|NCT00454818|B5|Baseline|Phase 2: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462230|NCT00454987|O1|Outcome|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462231|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462232|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462233|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462234|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462235|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462236|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462237|NCT00454987|O2|Outcome|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462238|NCT00454987|O1|Outcome|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462239|NCT00454987|E3|Reported Event|Meningitec+Hiberix Group|Previously primed (according to the routine UK immunisation schedule) with 3 doses of a Meningitec™ conjugate vaccine and a Hiberix™ containing vaccine before the age of 8 months without booster dose at 12 months of age (only for UK). All subjects received a booster dose of Infanrix-IPV™ and Menitorix™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462240|NCT00454987|E2|Reported Event|Meningitec Group|Previously primed in infancy with Meningitec™ and Pediacel™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462241|NCT00454987|E1|Reported Event|Menitorix Group|Previously primed in infancy with Menitorix™ and Infanrix-IPV™ and boosted with Menitorix™ (Priorix™ co-administered). All UK subjects received a booster dose of Infanrix-IPV™ at 40 to 43 months of age, intramuscularly in the deltoid region.
462242|NCT00454857|B1|Baseline|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462243|NCT00454857|P1|Participant Flow|Patients With ITP|Patients diagnosed with Immune (Idiopathic) Thrombocytopenic Purpura (ITP) were followed prospectively for a period of 12 months.
462244|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462245|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462246|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462247|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462248|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462249|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462250|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462251|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462252|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462253|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462254|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462255|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462256|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462257|NCT00454857|O1|Outcome|Patients With ITP|Patients diagnosed with ITP were followed prospectively for a period of 12 months.
462258|NCT00454857|E1|Reported Event|Overall Study|
462259|NCT00454818|B9|Baseline|Total|Total of all reporting groups
462260|NCT00454818|B8|Baseline|Phase 2: Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462261|NCT00454818|B7|Baseline|Phase 2: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462262|NCT00454818|B6|Baseline|Phase 2: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462366|NCT00454779|B2|Baseline|Chemotherapy Alone|Docetaxel + Cisplatin, control
462367|NCT00454779|B1|Baseline|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462264|NCT00454818|B4|Baseline|Phase 1: MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462265|NCT00454818|B3|Baseline|Phase 1: MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462266|NCT00454818|B2|Baseline|Phase 1: MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462267|NCT00454818|B1|Baseline|Phase 1: MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
462268|NCT00454818|P5|Participant Flow|Placebo|"Single dose of placebo administered by antegrade epicardial coronary artery infusion.~The placebo arm was included only in the Phase 2 randomized double-blind period."
462269|NCT00454818|P4|Participant Flow|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
462270|NCT00454818|P3|Participant Flow|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
462271|NCT00454818|P2|Participant Flow|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.
462272|NCT00454818|P1|Participant Flow|MYDICAR® Very Low Dose|"Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DNAase resistant particles (DRP) administered by antegrade epicardial coronary artery infusion.~This arm was included only in the Phase I open-label dose-escalation period."
462273|NCT00454818|O6|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462274|NCT00454818|O5|Outcome|All MYDICAR®|All participants who received a single infusion of MYDICAR® at any dose during the Phase 1 or Phase 2 studies.
462275|NCT00454818|O4|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462276|NCT00454818|O3|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462277|NCT00454818|O2|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462278|NCT00454818|O1|Outcome|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11 DRP administered by antegrade epicardial coronary artery infusion.
462279|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462280|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462281|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462282|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462283|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462284|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462285|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462286|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462287|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462288|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462289|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462290|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462291|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462292|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462293|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462294|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462295|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462296|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462297|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462298|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462299|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462300|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462301|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462302|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462303|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462304|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462305|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462306|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462307|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462308|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462309|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462310|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462311|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462312|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462313|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462314|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462315|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462316|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462368|NCT00454779|P2|Participant Flow|Chemotherapy Alone|Docetaxel + Cisplatin, control
462369|NCT00454779|P1|Participant Flow|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462317|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462318|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462319|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462320|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462321|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462322|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462323|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462324|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462325|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462326|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462327|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462328|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462329|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462330|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462331|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462332|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462333|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462334|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462335|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462336|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462337|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462338|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462339|NCT00454818|O4|Outcome|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462340|NCT00454818|O3|Outcome|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462341|NCT00454818|O2|Outcome|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462342|NCT00454818|O1|Outcome|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11 DRP administered by antegrade epicardial coronary artery infusion.
462343|NCT00454818|E5|Reported Event|Placebo|Single dose of placebo administered by antegrade epicardial coronary artery infusion.
462370|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462371|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462344|NCT00454818|E4|Reported Event|MYDICAR® High Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1E13 DRP administered by antegrade epicardial coronary artery infusion.
462345|NCT00454818|E3|Reported Event|MYDICAR® Mid Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 3E12 DRP administered by antegrade epicardial coronary artery infusion.
462346|NCT00454818|E2|Reported Event|MYDICAR® Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 6E11DRP administered by antegrade epicardial coronary artery infusion.
462347|NCT00454818|E1|Reported Event|MYDICAR® Very Low Dose|Single dose of MYDICAR®, a viral vector (adeno-associated virus serotype 1 [AAV1]) carrying the gene for sarcoplasmic reticulum Ca++-adenosine triphosphatase (SERCA2a), at a dose of 1.4E11DRP administered by antegrade epicardial coronary artery infusion.
462348|NCT00454805|B3|Baseline|Total|Total of all reporting groups
462349|NCT00454805|B2|Baseline|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462350|NCT00454805|B1|Baseline|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462351|NCT00454805|P2|Participant Flow|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462352|NCT00454805|P1|Participant Flow|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462353|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462354|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462355|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462356|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462357|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462358|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462359|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462360|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462361|NCT00454805|O2|Outcome|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462362|NCT00454805|O1|Outcome|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462363|NCT00454805|E2|Reported Event|Placebo|"Placebo+Fulvestrant 250 mg~Patients randomised to the control arm (fulvestrant + placebo) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: placebo to match cediranib (administered orally)"
462364|NCT00454805|E1|Reported Event|Cediranib 45 mg|"Cediranib 45 mg+Fulvestrant 250 mg~Patients randomised to the investigational arm (fulvestrant + cediranib) received treatment according to the following schedule:~Day 1: fulvestrant 500 mg im~Day 15: fulvestrant 250 mg im~Day 29, and every 28 days thereafter: fulvestrant 250 mg im~and daily: cediranib 45 mg (administered orally)"
462365|NCT00454779|B3|Baseline|Total|Total of all reporting groups
462375|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462376|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462377|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462378|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462379|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462380|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462381|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462382|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462383|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462384|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462385|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462386|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462387|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462388|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462389|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462390|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462391|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462392|NCT00454779|O2|Outcome|Chemotherapy Alone|Docetaxel + Cisplatin, control
462393|NCT00454779|O1|Outcome|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462394|NCT00454779|E2|Reported Event|Chemotherapy Alone|Docetaxel + Cisplatin, control
462395|NCT00454779|E1|Reported Event|Panitumumab Plus Chemotherapy|Panitumumab + Docetaxel + Cisplatin, experiment
462396|NCT00454649|B11|Baseline|Total|Total of all reporting groups
462397|NCT00454649|B10|Baseline|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462398|NCT00454649|B9|Baseline|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462399|NCT00454649|B8|Baseline|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462400|NCT00454649|B7|Baseline|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462401|NCT00454649|B6|Baseline|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462402|NCT00454649|B5|Baseline|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462403|NCT00454649|B4|Baseline|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462404|NCT00454649|B3|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462405|NCT00454649|B2|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462406|NCT00454649|B1|Baseline|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462407|NCT00454649|P10|Participant Flow|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462468|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
463649|NCT00451282|O2|Outcome|Usual Care|Injured children receiving usual care
462408|NCT00454649|P9|Participant Flow|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462409|NCT00454649|P8|Participant Flow|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462410|NCT00454649|P7|Participant Flow|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462411|NCT00454649|P6|Participant Flow|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462412|NCT00454649|P5|Participant Flow|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462413|NCT00454649|P4|Participant Flow|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462414|NCT00454649|P3|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462415|NCT00454649|P2|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462416|NCT00454649|P1|Participant Flow|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462417|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462418|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 18 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462419|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462420|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462421|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462422|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462423|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462424|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462542|NCT00454636|B3|Baseline|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462425|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/meter square (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462426|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462427|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462428|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462429|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462430|NCT00454649|O1|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462431|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462432|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462433|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462434|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462435|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462436|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462437|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462438|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462439|NCT00454649|O2|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462440|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462441|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462442|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462443|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462444|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462445|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462467|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462446|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462447|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462448|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462449|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462450|NCT00454649|O1|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462451|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462452|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462453|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462454|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462455|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462456|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462457|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462458|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462459|NCT00454649|O2|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462460|NCT00454649|O1|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462461|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462462|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462463|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462464|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462465|NCT00454649|O1|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462466|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462631|NCT00454532|O2|Outcome|Level 2|20g/day
462469|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462470|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462471|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462472|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462473|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462474|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Combined Cohort 1, 2, 3)|Combined Data from all participants in cohort 1, 2 and 3.
462475|NCT00454649|O1|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462476|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462477|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462478|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462479|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462480|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462481|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462482|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462483|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462484|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462485|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462486|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462487|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462488|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462489|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462632|NCT00454532|O1|Outcome|Level 1|10g/day
462490|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462491|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462492|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462493|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462494|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462495|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462496|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462497|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462498|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462499|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462500|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462501|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462502|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462503|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462504|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462505|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462506|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462523|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462507|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462508|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462509|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462510|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462511|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462512|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Cisplatin 75 mg/m^2 and pemetrexed 500 mg/m^2 administered as infusion on Day 1 Cycle 1 and all subsequent cycles.
462513|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|AG-013736 oral tablet of 5 mg administered BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval. Cisplatin 80 mg/m^2 administered as infusion on Day 1 of Cycle 1 and all subsequent cycles. Gemcitabine 1250 mg/m^2 administered as infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles.
462514|NCT00454649|O7|Outcome|Axitinib + Capecitabine (Cohort 7)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1250 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
462515|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Capecitabine (1000 mg/m^2) administered orally BID from Day 1 to Day 14 of every cycle.
462516|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1. AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (cycle length 21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Docetaxel 100 mg/m^2 administered as 60-minute infusion on Day 1 of every cycle.
462517|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|AG-013736 oral tablet of 5 mg administered BID from Day 1 to Day 25 of Cycle 1 (cycle length 28 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel 90 mg/m^2 administered as 60-minute infusion on Day 1, 8, and 15 of every cycle.
462518|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|AG-013736 oral tablet of 5 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
462519|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|AG-013736 3 oral tablets of 1 mg administered BID as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin at a dose to target AUC of 6.0 mg*min/mL as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
462520|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) oral tablet of 1 mg (milligram) administered twice daily (BID) as lead in dose from Day -5, -4 or -3 to Day 2 of Cycle 1 (cycle length 21 days). AG-013736 standard dose of 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 and all subsequent cycles with no interval between two cycles. Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) as 30-minute infusion administered once weekly from Day 1 of Cycle 1 and all subsequent cycles.
462521|NCT00454649|O9|Outcome|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462522|NCT00454649|O8|Outcome|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462524|NCT00454649|O6|Outcome|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462525|NCT00454649|O5|Outcome|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462526|NCT00454649|O4|Outcome|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462527|NCT00454649|O3|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462528|NCT00454649|O2|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462529|NCT00454649|O1|Outcome|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462530|NCT00454649|E10|Reported Event|Axitinib + Pemetrexed + Cisplatin (Cohort 9)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Pemetrexed (500 mg/m^2) 10-minute infusion followed by cisplatin (75 mg/m^2) infusion on Day 1 of each cycle.
462531|NCT00454649|E9|Reported Event|Axitinib + Gemcitabine + Cisplatin (Cohort 8)|Axitinib (AG-013736) 5 mg tablet orally BID from Day -5, -4 or -3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Gemcitabine (1250 mg/m^2) 30-minute infusion on Day 1 and Day 8 of Cycle 1 and all subsequent cycles followed by cisplatin (80 mg/m^2) infusion on Day 1 of each cycle.
462532|NCT00454649|E8|Reported Event|Axitinib + Capecitabine (Cohort 7)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1250 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462533|NCT00454649|E7|Reported Event|Axitinib + Capecitabine (Cohort 6)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Capecitabine (1000 mg/m^2) orally BID from Day 1 to Day 14 of each cycle.
462534|NCT00454649|E6|Reported Event|Axitinib + Docetaxel (Cohort 5)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1. Axitinib (AG-013736) 5 mg oral tablet BID administered from Day 3 to Day 18 of Cycle 1 (21 days) and then without interruption from Day 3 of Cycle 2 and all subsequent cycles. Docetaxel (100 mg/m^2) 60-minute infusion on Day 1 of each cycle.
462535|NCT00454649|E5|Reported Event|Axitinib + Docetaxel + Carboplatin (Cohort 4a)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Docetaxel (75 mg/m^2) 60-minute infusion on Day 1 of every cycle. Carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462536|NCT00454649|E4|Reported Event|Axitinib + Paclitaxel (Cohort 4)|Axitinib (AG-013736) 5 mg tablet orally BID from Day 1 to Day 25 of Cycle 1 (28 days) and then without interruption from Day 3 for Cycle 2 (28 days) and all subsequent cycles (28 days). Paclitaxel (90 mg/m^2) 60-minute infusion on Day 1, 8, and 15 of each cycle.
462537|NCT00454649|E3|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 3)|Axitinib (AG-013736) 5 mg tablet orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462538|NCT00454649|E2|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 2)|Axitinib (AG-013736) 3 tablets of 1 mg orally BID as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel (200 mg/m^2) 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target AUC of 6.0 mg*min/mL on Day 1 of Cycle 1 and all subsequent cycles.
462539|NCT00454649|E1|Reported Event|Axitinib + Paclitaxel + Carboplatin (Cohort 1)|Axitinib (AG-013736) 1 milligram (mg) tablet orally twice daily (BID) as lead in dose from Day -5, -4 or -3 through Day 2 of Cycle 1 (21 days). Axitinib (AG-013736) 5 mg tablet orally BID from Day 3 to Day 18 of Cycle 1 and Day 3 to Day 20 of Cycle 2 (21 days) and all subsequent cycles (21 days). Paclitaxel [200 milligram/square meter (mg/m^2)] 3-hour infusion followed by carboplatin 30-minutes infusion at a dose to target area under the concentration-time curve (AUC) of 6.0 milligram*minute/milliliter (mg*min/mL) on Day 1 of Cycle 1 and all subsequent cycles.
462540|NCT00454636|B5|Baseline|Total|Total of all reporting groups
462541|NCT00454636|B4|Baseline|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462543|NCT00454636|B2|Baseline|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462544|NCT00454636|B1|Baseline|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462545|NCT00454636|P4|Participant Flow|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462546|NCT00454636|P3|Participant Flow|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462547|NCT00454636|P2|Participant Flow|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462548|NCT00454636|P1|Participant Flow|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462549|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462550|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462551|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462552|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462553|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462554|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462555|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462556|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462557|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462558|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462559|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462560|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462561|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462562|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462563|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462564|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462565|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462566|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462567|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462633|NCT00454532|O4|Outcome|Level 4|40g/day
462634|NCT00454532|O3|Outcome|Level 3|30g/day
462635|NCT00454532|O2|Outcome|Level 2|20g/day
462568|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462569|NCT00454636|O4|Outcome|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462570|NCT00454636|O3|Outcome|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462571|NCT00454636|O2|Outcome|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462572|NCT00454636|O1|Outcome|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462573|NCT00454636|E4|Reported Event|Docetaxel / Cisplatin / Capecitabine|Docetaxel, 60 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 825 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks.
462574|NCT00454636|E3|Reported Event|Epirubicin / Oxaliplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; oxaliplatin, 130 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2 orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462575|NCT00454636|E2|Reported Event|Epirubicin / Cisplatin / Capecitabine|Epirubicin, 50 mg/m2/day, IV, every 3 weeks; cisplatin, 60 mg/m2/day, IV, every 3 weeks; capecitabine, 625mg/m2, orally, twice daily per 3-week cycle. Study drugs were administered for at least 24 weeks
462576|NCT00454636|E1|Reported Event|Cisplatin / Capecitabine|Cisplatin, 80 mg/m2/day, intravenous (IV), every 3 weeks; capecitabine, 1,000 mg/m2, orally, twice daily for 2 weeks, followed by 1 week of rest in each cycle. Study drugs were administered for at least 24 weeks
462577|NCT00454584|B4|Baseline|Total|Total of all reporting groups
462578|NCT00454584|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462579|NCT00454584|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462580|NCT00454584|B1|Baseline|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462581|NCT00454584|P6|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
462582|NCT00454584|P5|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
462583|NCT00454584|P4|Participant Flow|Etanercept (After CP)|After Controlled period (Week 12- 64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40
462584|NCT00454584|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
462585|NCT00454584|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
462586|NCT00454584|P1|Participant Flow|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
462587|NCT00454584|O2|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462588|NCT00454584|O1|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462589|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462590|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462591|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462592|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462636|NCT00454532|O1|Outcome|Level 1|10g/day
462637|NCT00454532|E4|Reported Event|Level 4|40g/day
462638|NCT00454532|E3|Reported Event|Level 3|30g/day
462593|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462594|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462595|NCT00454584|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462596|NCT00454584|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 . Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 45 mg at Week 16. Participants with PGA lesser than or equal to 2 at Week 12 received ustekinumab 45 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462597|NCT00454584|O1|Outcome|Group I: Etanercept|Participants received Etanercept 50 mg twice weekly through Week 12. Participants with PGA greater than or equal to 3 at Week 12 received ustekinumab 90 mg at Week 16 and 20. Participants with PGA leeser than or equal to 2 at Week 12 received ustekinumab 90 mg upon losing PGA response (PGA greater than or equal to 3) and 4 weeks after.
462598|NCT00454584|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 90 mg at Weeks 0 -> retreated with ustekinumab 90 mg if becoming a nonresponder during Week 12 and Week 40.
462599|NCT00454584|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-64) – receiving ustekinumab 45 mg at Weeks 0 -> retreated with ustekinumab 45 mg if becoming a nonresponder during Week 12 and Week 40.
462600|NCT00454584|E5|Reported Event|Etanercept -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> receiving ustekinumab 90 mg upon becoming a nonresponder during Week 12 and Week 40. This group is a subpopulation of Etanercept (after CP).
462601|NCT00454584|E4|Reported Event|Etanercept (After CP)|After Controlled period (Week 12-64) – receiving etanercept at Weeks 0 -> prior to being treated with ustekinumab
462602|NCT00454584|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
462603|NCT00454584|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
462604|NCT00454584|E1|Reported Event|Etanercept (CP)|Controlled period (Week 0-12) - Etanercept group
462605|NCT00454571|B3|Baseline|Total|Total of all reporting groups
462606|NCT00454571|B2|Baseline|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
462607|NCT00454571|B1|Baseline|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
462608|NCT00454571|P2|Participant Flow|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
462609|NCT00454571|P1|Participant Flow|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
462610|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
462611|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
462612|NCT00454571|O2|Outcome|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
462613|NCT00454571|O1|Outcome|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
462614|NCT00454571|E2|Reported Event|Leuprolide Acetate and Goserelin Acetate Only|"Patients undergo observation after treatment with leuprolide acetate and goserelin acetate.~leuprolide acetate~goserelin acetate"
462615|NCT00454571|E1|Reported Event|Pazopanib, Leuprolide Acetate, and Goserelin Acetate|"Patients receive pazopanib hydrochloride PO QD on days 1-28 after treatment with leuprolide acetate and goserelin acetate. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~leuprolide acetate~goserelin acetate"
462616|NCT00454532|B5|Baseline|Total|Total of all reporting groups
462617|NCT00454532|B4|Baseline|Level 4|40g/day
462618|NCT00454532|B3|Baseline|Level 3|30g/day
462619|NCT00454532|B2|Baseline|Level 2|20g/day
462620|NCT00454532|B1|Baseline|Level 1|10g/day
462621|NCT00454532|P4|Participant Flow|Level 4|40g/day
462622|NCT00454532|P3|Participant Flow|Level 3|30g/day
462623|NCT00454532|P2|Participant Flow|Level 2|20g/day
462624|NCT00454532|P1|Participant Flow|Level 1|10g/day
462625|NCT00454532|O4|Outcome|Level 4|40g/day
462626|NCT00454532|O3|Outcome|Level 3|30g/day
462627|NCT00454532|O2|Outcome|Level 2|20g/day
462628|NCT00454532|O1|Outcome|Level 1|10g/day
462629|NCT00454532|O4|Outcome|Level 4|40g/day
462630|NCT00454532|O3|Outcome|Level 3|30g/day
462642|NCT00454363|B2|Baseline|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462643|NCT00454363|B1|Baseline|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462644|NCT00454363|P2|Participant Flow|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462645|NCT00454363|P1|Participant Flow|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462646|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462647|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462648|NCT00454363|O2|Outcome|Pazopanib + pNET|Pancreatic Neuroendocrine (pNET) tumor type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462649|NCT00454363|O1|Outcome|Pazopanib + Carcinoid|Carcinoid Tumor Type: Oral Pazopanib hydrochloride 800 mg once daily on days 1-28.
462650|NCT00454363|E1|Reported Event|Pazopanib|Oral pazopanib hydrochloride once daily on days 1-28.
462651|NCT00454246|B4|Baseline|Total|Total of all reporting groups
462652|NCT00454246|B3|Baseline|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462653|NCT00454246|B2|Baseline|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462654|NCT00454246|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462655|NCT00454246|P3|Participant Flow|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462656|NCT00454246|P2|Participant Flow|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462657|NCT00454246|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462658|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462659|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462660|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462661|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462662|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462663|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462664|NCT00454246|O3|Outcome|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462665|NCT00454246|O2|Outcome|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462869|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462666|NCT00454246|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462667|NCT00454246|E3|Reported Event|Darbepoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of darbepoetin subcutaneous once every two weeks for a minimum of 5 months and a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462668|NCT00454246|E2|Reported Event|Epoetin Alfa|"Patients randomized to the reference arm continued to receive their standard of care dose and regimen of epoetin alfa subcutaneous once per week for a minimum of 5 months to a maximum of 18 months. Subcutaneous injections were to be administered in the same part of the body (ie, thigh, abdomen or arm) throughout the study.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462669|NCT00454246|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|"120-360 micrograms methoxy polyethylene glycol-epoetin beta subcutaneous (sc) monthly starting dose, for a minimum of 5 months to a maximum of 18 months.~Dosage was adjusted to maintain a hemoglobin target range of ≥10 g/dL to ≤12 g/dL."
462670|NCT00454207|B3|Baseline|Total|Total of all reporting groups
462671|NCT00454207|B2|Baseline|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
462672|NCT00454207|B1|Baseline|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462673|NCT00454207|P2|Participant Flow|Sildenafil: Participants Who Entered the Study From Part II|Consists of participants who newly entered the study from Part II period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to subjects after approval for the indication of pulmonary arterial hypertension).
462674|NCT00454207|P1|Participant Flow|Sildenafil: Participant Who Entered the Study From Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462675|NCT00454207|O1|Outcome|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
462676|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462677|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462678|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462679|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462680|NCT00454207|O1|Outcome|Sildenafil:Pharmacokinetic Analysis Participant|Consists of participants who received sildenafil monotherapy, without administration of other treatment drugs for pulmonary arterial hypertension, in Part I or II, and satisfied the inclusion criteria for pharmacokinetics evaluation without violating the exclusion criteria. The participants were treated with sildenafil 20 mg three times a day orally in Part I period(12 weeks) and Part II period (longterm treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462681|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
463120|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
462682|NCT00454207|O1|Outcome|Sildenafil: Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462683|NCT00454207|O4|Outcome|Sildenafil: Part II, Functional Class at Baseline: IV|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were IV. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462684|NCT00454207|O3|Outcome|Sildenafil: Part II, Functional Class at Baseline: III|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were III. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462685|NCT00454207|O2|Outcome|Sildenafil:Part II, Functional Class at Baseline: II|Consists of participants who newly entered the study from Part II period in Week 0, and whose who functional class at baseline were II. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462686|NCT00454207|O1|Outcome|Sildenafil:Part II, Functional Class at Baseline: I|Consists of participants who newly entered the study from Part II period in Week 0, and whose WHO functional class at baseline were I. The participants had been receiving sildenafil at doses higher than 60 mg/day before the start of this study.The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462687|NCT00454207|O1|Outcome|Sildenafil:Part II|Consists of participants who newly entered the study from Part II period in Week 0 and had been receiving sildenafil at doses higher than 60 mg/day before the start of this study. The participants were treated with sildenafil 20 mg three times a day orally in Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462688|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462689|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462690|NCT00454207|O4|Outcome|Sildenafil, Part I, Functional Class at Baseline:IV|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were IV. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462691|NCT00454207|O3|Outcome|Sildenafil, Part I, Functional Class at Baseline: III|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were III. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462692|NCT00454207|O2|Outcome|Sildenafil:Part I, Functional Class at Baseline: II|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were II. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462693|NCT00454207|O1|Outcome|Sildenafil:Part I , Functional Class at Baseline: I|Consists of participants who entered the study from Part I period in Week 0, and whose WHO functional class at baseline were I. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462694|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462695|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462696|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462697|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462698|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462699|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462700|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462701|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462702|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462703|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462704|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462705|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462706|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462707|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462708|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462709|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462710|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462711|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462712|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462713|NCT00454207|O1|Outcome|Sildenafil:Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462870|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462714|NCT00454207|O1|Outcome|Sildenafil: Part I|Consists of participants who entered the study from Part I period in Week 0. The participants were treated with sildenafil 20 mg three times a day orally in Part I period (12 weeks) and Part II period (long-term treatment period, until a proper system was established to provide sildenafil to participants after approval for the indication of pulmonary arterial hypertension).
462715|NCT00454207|E1|Reported Event|Sildenafil: Part I and Part II|Consists of participants who entered the study from Part I period plus participants who entered the study from Part II period.
462716|NCT00454194|B3|Baseline|Total|Total of all reporting groups
462717|NCT00454194|B2|Baseline|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462718|NCT00454194|B1|Baseline|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462719|NCT00454194|P2|Participant Flow|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462720|NCT00454194|P1|Participant Flow|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462721|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462722|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462723|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462724|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462725|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462726|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462727|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462728|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462729|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462730|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462731|NCT00454194|O2|Outcome|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462732|NCT00454194|O1|Outcome|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462733|NCT00454194|E2|Reported Event|Arm II (Pemetrexed)|Patients receive pemetrexed disodium IV over 10 minutes on day 1.
462734|NCT00454194|E1|Reported Event|Arm I (Pemetrexed + Sorafenib)|Patients receive oral sorafenib tosylate twice daily on days 1-21 and pemetrexed disodium IV over 10 minutes on day 1.
462735|NCT00454181|B3|Baseline|Total|Total of all reporting groups
462736|NCT00454181|B2|Baseline|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462737|NCT00454181|B1|Baseline|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462738|NCT00454181|P2|Participant Flow|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462739|NCT00454181|P1|Participant Flow|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462740|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462741|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462742|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462743|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462744|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462745|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462746|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462747|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462748|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462749|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462750|NCT00454181|O2|Outcome|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462751|NCT00454181|O1|Outcome|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462752|NCT00454181|E2|Reported Event|Placebo Lozenges|200 mg lozenges containing anhydrous crystalline maltose
462753|NCT00454181|E1|Reported Event|IFN Lozenges|500 IU Interferon-alpha lozenges for oral dissolution
462754|NCT00454142|B1|Baseline|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462755|NCT00454142|P1|Participant Flow|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462756|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462757|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462871|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462758|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462759|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462760|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462761|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462762|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462763|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462764|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462765|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO daily (QD) on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462766|NCT00454142|O1|Outcome|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462767|NCT00454142|O1|Outcome|Treatment (Pazopanib Hydrochloride)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~pazopanib hydrochloride: Given PO~pharmacological study: Correlative studies~computed tomography: Correlative studies"
462768|NCT00454142|E1|Reported Event|Treatment (Tyrosine Kinase Inhibitor)|"Patients receive pazopanib hydrochloride PO QD on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~computed tomography : Correlative studies~pharmacological study : Correlative studies~pazopanib hydrochloride : Given PO"
462769|NCT00453362|B1|Baseline|Erlotinib|Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.
462770|NCT00453362|P1|Participant Flow|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib participants underwent FDG-PET (2-deoxy-2-[18F]fluoro-D-glucose-Positron Emission Tomogrpahy)and FLT-PET (3'-deoxy-3'-[18F]fluorothymidine-Positron Emission Tomogrpahy) scans.~FDG-PET intravenous injection dosage was based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose was 7 mCi."
462771|NCT00453362|O1|Outcome|Overall Study Participants|"All Participants who underwent any FLT-PET scan during the study (including screening) were included in the analysis.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
462772|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
462773|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
462774|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
462775|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
462776|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
462777|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
462778|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
462779|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight no to exceed 15 mCi."
462780|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responder|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
462781|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
462782|NCT00453362|O2|Outcome|Erlotinib_FLT Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had Progressive disease on FLT-PET scans at Day 56 were included in this group."
462783|NCT00453362|O1|Outcome|Erlotinib_FLT Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
462784|NCT00453362|O2|Outcome|Erlotinib_ FLT Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who did not have CR/PR on FLT-PET scans at Day 56 were included in this group."
462785|NCT00453362|O1|Outcome|Erlotinib_FLT Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi. Patients who had CR/PR on FLT-PET scans at Day 56 were included in this group."
462786|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FLT-PET was scheduled on screening, Day 14 and Day 56. FLT intravenous injection dose was 7 mCi."
462787|NCT00453362|O2|Outcome|Erlotinib_FDG Progressive Disease With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had Progressive disease on FDG-PET scans at Day 56 were included in this group."
462788|NCT00453362|O1|Outcome|Erlotinib_FDG Responders With CT SD at Day 56|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
462789|NCT00453362|O1|Outcome|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi."
462790|NCT00453362|O2|Outcome|Erlotinib_ FDG Non-Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who did not have CR/PR on FDG-PET scans at Day 56 were included in this group."
462791|NCT00453362|O1|Outcome|Erlotinib_FDG Responders|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~FDG-PET was scheduled on screening, Day 14 and Day 56. FDG intravenous injection-dosage based on participant's weight not to exceed 15 mCi. Patients who had CR/PR on FDG-PET scans at Day 56 were included in this group."
462872|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
463650|NCT00451282|O1|Outcome|Intervention|Injured children receiving Stepped Preventive Care intervention
462792|NCT00453362|E1|Reported Event|Erlotinib|"Erlotinib 150 mg/day taken orally at approximately the same time of day with 200 mL (6-8 Ounces) of water on an empty stomach. Participants received Erlotinib for 1 year or until they developed progressive disease or intolerable toxicity.~After 14 days and after 56 days of treatment with Erlotinib, participants underwent FDG-PET and FLT-PET scans. FDG-PET intravenous injection-dosage based on participant's weight not to exceed 15 mCi and FLT-PET intravenous dose of 7 mCi."
462793|NCT00453349|B3|Baseline|Total|Total of all reporting groups
462794|NCT00453349|B2|Baseline|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462795|NCT00453349|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462796|NCT00453349|P2|Participant Flow|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462797|NCT00453349|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462798|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462799|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462800|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462801|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462802|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462803|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462804|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462805|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462806|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462807|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462808|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462809|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462810|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462811|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462812|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462813|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462814|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462815|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462816|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462817|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462818|NCT00453349|O2|Outcome|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462819|NCT00453349|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462820|NCT00453349|E2|Reported Event|Levofloxacin Plus Metronidazole|Levofloxacin 500 mg by mouth (PO) once daily for 14 days plus Metronidazole 500 mg (PO) twice daily for 14 days
462821|NCT00453349|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY12-8039) 400 mg by mouth (PO) once daily for 14 days
462822|NCT00453336|B1|Baseline|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
462823|NCT00453336|P1|Participant Flow|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
462824|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
462825|NCT00453336|O1|Outcome|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
462873|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
463121|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
462826|NCT00453336|E1|Reported Event|Single Arm|"Photodynamic Therapy : Laser Activation. The time of exposure and the power of the laser are computed based on the dosimetry in appendix A using a computed energy dose of 75 to 150 joules, depending on the depth of penetration desired.~Porfimer Sodium : Day 1 of Therapy. An IV access (of 20 gauge or larger) is started and 2 mg/kg of Porfimer Sodium (Photofrin®) is given intravenously. Once completed the patient puts on the light protective gear and is sent home."
462827|NCT00453310|B1|Baseline|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
462828|NCT00453310|P1|Participant Flow|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
462829|NCT00453310|O1|Outcome|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
462830|NCT00453310|E1|Reported Event|Sunitinib Malate|"The dose of sunitinib malate will be a continuous daily dose of 37.5 mg administered orally for 6 weeks. The cycle of therapy is 42 days (or 6 weeks)~sunitinib malate"
462831|NCT00454116|B4|Baseline|Total|Total of all reporting groups
462832|NCT00454116|B3|Baseline|Placebo Plus FOLFIRI|placebo plus FOLFIRI
462833|NCT00454116|B2|Baseline|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
462834|NCT00454116|B1|Baseline|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
462835|NCT00454116|P3|Participant Flow|Placebo Plus FOLFIRI|placebo plus FOLFIRI
462836|NCT00454116|P2|Participant Flow|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
462837|NCT00454116|P1|Participant Flow|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
462838|NCT00454116|O3|Outcome|Placebo Plus FOLFIRI|placebo plus FOLFIRI
462839|NCT00454116|O2|Outcome|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
462840|NCT00454116|O1|Outcome|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
462841|NCT00454116|E3|Reported Event|Placebo Plus FOLFIRI|placebo plus FOLFIRI
462842|NCT00454116|E2|Reported Event|Vandetanib 300 mg Plus FOLFIRI|vandetanib 300 mg plus FOLFIRI
462843|NCT00454116|E1|Reported Event|Vandetanib 100 mg Plus FOLFIRI|vandetanib 100 mg plus FOLFIRI
462844|NCT00454051|B3|Baseline|Total|Total of all reporting groups
462845|NCT00454051|B2|Baseline|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462846|NCT00454051|B1|Baseline|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462847|NCT00454051|P2|Participant Flow|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462848|NCT00454051|P1|Participant Flow|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462849|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462850|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462851|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462852|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462853|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462854|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462855|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462856|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462857|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462858|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462859|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462860|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462861|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462862|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462863|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462864|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462865|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462866|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462867|NCT00454051|O2|Outcome|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462868|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462874|NCT00454051|O1|Outcome|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462875|NCT00454051|E2|Reported Event|Placebo|Placebo was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks.
462876|NCT00454051|E1|Reported Event|Omalizumab|Omalizumab was injected subcutaneously every 2 weeks or every 4 weeks for 16 weeks. Dose and dosing interval were determined based on patient body weight and pre-treatment serum IgE level.
462877|NCT00453999|B4|Baseline|Total|Total of all reporting groups
462878|NCT00453999|B3|Baseline|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462879|NCT00453999|B2|Baseline|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462880|NCT00453999|B1|Baseline|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462881|NCT00453999|P3|Participant Flow|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462882|NCT00453999|P2|Participant Flow|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462883|NCT00453999|P1|Participant Flow|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462884|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462885|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462886|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462887|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462888|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462889|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462890|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462891|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462892|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462893|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462894|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462895|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462896|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462897|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462898|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462899|NCT00453999|O3|Outcome|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462900|NCT00453999|O2|Outcome|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution ) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462901|NCT00453999|O1|Outcome|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462902|NCT00453999|E3|Reported Event|Oseltamivir|Placebo peramivir infusion (over 15 minutes) and a 75-mg dose of oseltamivir suspension (6.25 mL)
462903|NCT00453999|E2|Reported Event|Peramivir 400 mg|Peramivir (400 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL)
462904|NCT00453999|E1|Reported Event|Peramivir 200 mg|Peramivir (200 mg in 100 mL of solution) intravenous infusion (over 15 minutes) and an orally administered oseltamivir placebo suspension (6.25 mL) treatment
462905|NCT00453986|B6|Baseline|Total|Total of all reporting groups
462906|NCT00453986|B5|Baseline|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462907|NCT00453986|B4|Baseline|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462908|NCT00453986|B3|Baseline|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462909|NCT00453986|B2|Baseline|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462910|NCT00453986|B1|Baseline|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462911|NCT00453986|P5|Participant Flow|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462912|NCT00453986|P4|Participant Flow|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462913|NCT00453986|P3|Participant Flow|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462914|NCT00453986|P2|Participant Flow|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462915|NCT00453986|P1|Participant Flow|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462916|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462917|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Group Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462918|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462919|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462920|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462921|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462922|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462923|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462924|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462925|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462926|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462927|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462928|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462929|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462930|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462931|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462932|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462933|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462934|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462935|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462936|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462937|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462938|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462939|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462940|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462941|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462942|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462943|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462944|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462945|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462946|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462947|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462948|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462949|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462950|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462951|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462952|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462953|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462954|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462955|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462956|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462957|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462958|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462959|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462960|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462961|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462962|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462963|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462964|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462965|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462966|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462967|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462968|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462969|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462970|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462971|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462972|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462973|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462974|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462975|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462976|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462977|NCT00453986|O2|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462978|NCT00453986|O1|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462979|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462980|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462981|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462982|NCT00453986|O3|Outcome|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462983|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462984|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462985|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462986|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462987|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462988|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462989|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462990|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462991|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
463112|NCT00452699|B1|Baseline|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
462992|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462993|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462994|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462995|NCT00453986|O2|Outcome|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462996|NCT00453986|O1|Outcome|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
462997|NCT00453986|O2|Outcome|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of Fluarix vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
462998|NCT00453986|O1|Outcome|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
462999|NCT00453986|O3|Outcome|Nimenrix C Group|subjects received 1 dose of Nimenrix™ Lot C at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
463000|NCT00453986|O2|Outcome|Nimenrix B Group|subjects received 1 dose of Nimenrix™ Lot B at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
463001|NCT00453986|O1|Outcome|Nimenrix A Group|subjects received 1 dose of Nimenrix™ Lot A at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
463002|NCT00453986|E5|Reported Event|Mencevax ACWY (Flu Cohort) Group|Mencevax ACWY Group from the Flu vaccine cohort. MencevaxTM ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
463003|NCT00453986|E4|Reported Event|Nimenrix (Flu Cohort) Group|Nimenrix A Group, Nimenrix B Group and Nimenrix C Group pooled groups from the Flu vaccine cohort. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
463004|NCT00453986|E3|Reported Event|Nimenrix+Fluarix Group|subjects received 1 dose of Nimenrix™ Lot A co-administered with Fluarix™ vaccines at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm. Fluarix™ vaccine was administered by intramuscular injection in the deltoid region of the dominant arm.
463005|NCT00453986|E2|Reported Event|Mencevax ACWY Group|subjects received 1 dose of Mencevax™ ACWY vaccine at Month 0. Mencevax™ ACWY vaccine was administered by subcutaneous injection in the non-dominant upper arm.
463006|NCT00453986|E1|Reported Event|Nimenrix Group|subjects received Nimenrix™ (Lots A without co-administration of FluarixTM vaccine, B and C) at Month 0. Nimenrix™ vaccine was administered by intramuscular injection in the deltoid region of the non-dominant arm.
463007|NCT00453973|B3|Baseline|Pooled AF37702 Inj.|
463008|NCT00453973|B2|Baseline|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
463009|NCT00453973|B1|Baseline|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
463010|NCT00453973|P2|Participant Flow|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
463011|NCT00453973|P1|Participant Flow|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
463012|NCT00453973|O2|Outcome|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
463113|NCT00452699|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463114|NCT00452699|P1|Participant Flow|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463013|NCT00453973|O1|Outcome|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
463014|NCT00453973|E2|Reported Event|Treatment Initiation in Non-Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were not on dialysis and not on erythropoiesis stimulating agents (ESAs), and who received peginesatide (NCT00228436). The median first dose at study start was 0.024 mg/kg with an interquartile range of 0.017 to 0.035 mg/kg. This group is categorized as Initiation of Treatment in Non-Dialysis Participants regardless of dialysis status at the start of or during this study."
463015|NCT00453973|E1|Reported Event|Maintenance Switch in Dialysis Participants|"Participants were from a prior Affymax peginesatide treatment study conducted in participants who were on dialysis and had been on Epoetin at study entry, and who were switched to peginesatide (NCT00434330). The median first dose at study start was 0.044 milligram per kilogram (mg/kg) with an interquartile range of 0.028 to 0.076 mg/kg. This group is categorized as Maintenance Switch in Dialysis Participants regardless of dialysis status at the start of or during this study."
463016|NCT00453206|B1|Baseline|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
463017|NCT00453206|P1|Participant Flow|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
463018|NCT00453206|O1|Outcome|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
463019|NCT00453206|E1|Reported Event|Reduced Intensity Allogeneic Cell Transplantation|reduced intensisty transplant are those that do not completely eliminate the patient's stem cells prior to recieving the bone marrow transplant
463020|NCT00453193|B1|Baseline|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
463021|NCT00453193|P1|Participant Flow|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
463022|NCT00453193|O1|Outcome|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
463023|NCT00453193|E1|Reported Event|Alemtuzumab + Pentostatin|Alemtuzumab 30 mg intravenous (IV) three times weekly; Pentostatin 4 mg/m^2 IV weekly for 4 weeks then every 2 weeks
463024|NCT00453154|B4|Baseline|Total|Total of all reporting groups
463025|NCT00453154|B3|Baseline|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
463026|NCT00453154|B2|Baseline|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463027|NCT00453154|B1|Baseline|Phase I|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463028|NCT00453154|P4|Participant Flow|Double Blind Sunitinib Maintenance|Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
463029|NCT00453154|P3|Participant Flow|Double Blind Placebo Maintenance With Optional Crossover|"Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.~At progression, participants receiving placebo could cross over to receive open label sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463030|NCT00453154|P2|Participant Flow|Phase II Combination Chemotherapy|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IVover 1 hour on days 1, 2, and 3 every cycle"
463031|NCT00453154|P1|Participant Flow|Phase 1B|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463032|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
463033|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463115|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463116|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463034|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
463035|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463036|NCT00453154|O2|Outcome|Arm II (Combination Chemotherapy + Placebo Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression."
463037|NCT00453154|O1|Outcome|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|"Participants will receive the following combination chemotherapy for 4-6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle OR Carboplatin AUC = 5* by IV Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle~Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463038|NCT00453154|O3|Outcome|Cohort 3|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 50 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463039|NCT00453154|O2|Outcome|Cohort 2|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 37.5 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463040|NCT00453154|O1|Outcome|Cohort 1|"Participants will receive the following combination chemotherapy for 6 cycles (21 days):~Cisplatin 80 mg/m^2 by IV over 1 hour on day 1 every cycle Etoposide 100 mg/m^2 by IV over 1 hour on days 1, 2, and 3 every cycle Sunitinib 25 mg oral, daily days 1-14 every cycle~Maintenance: Following 6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression."
463041|NCT00453154|E2|Reported Event|Arm II (Combination Chemotherapy + Placebo Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start placebo at 150 mg on day 1, then 37.5 daily until disease progression.
463042|NCT00453154|E1|Reported Event|Arm I (Combination Chemotherapy + Sunitinib Maintenance)|Maintenance: Following 4-6 cycles of combination chemotherapy, start sunitinib at 150 mg on day 1, then 37.5 daily until disease progression.
463043|NCT00453102|B1|Baseline|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463044|NCT00453102|P1|Participant Flow|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463045|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463046|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463047|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463048|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463117|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463049|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463050|NCT00453102|O1|Outcome|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463051|NCT00453102|E1|Reported Event|Zevalin + Rituximab|"Ibritumomab Tiuxetan (Zevalin) + Rituximab~Rituximab: IV Infusion of 250mg/m² of Rituximab Within 4 hours on Days 1, 7, 8, 9 0.4 millicuries (mCi)/kilogram (kg) (14.8 megabecquerels (MBq)/kilogram (kg)) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³~Ibritumomab Tiuxetan: IV injection of Y-90 Zevalin® over 10 minutes on Days 1, 7, 8, 9:~0.4 mCi/kg (14.8 MBq/kg) for patients with normal platelet count 0.3 mCi/kg (11.1 MBq/kg) for patients with platelet count of 100,000-149,000 cells/mm³"
463052|NCT00453063|B3|Baseline|Total|Total of all reporting groups
463053|NCT00453063|B2|Baseline|Placebo|Two sprays in each nostril once daily
463054|NCT00453063|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463055|NCT00453063|P2|Participant Flow|Placebo|Two sprays in each nostril once daily
463056|NCT00453063|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463057|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
463058|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463059|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
463060|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463061|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
463062|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463063|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
463064|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463065|NCT00453063|O2|Outcome|Placebo|Two sprays in each nostril once daily
463066|NCT00453063|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463067|NCT00453063|E2|Reported Event|Placebo|Two sprays in each nostril once daily
463068|NCT00453063|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|MFNS 200 mcg (two sprays in each nostril) once daily (QD) in the morning. Each spray is equal to 50 mcg.
463069|NCT00452868|B1|Baseline|Donepezil|
463070|NCT00452868|P1|Participant Flow|Donepezil|Patients less than 35 kilograms(kg): Donepezil 5 milligrams (mg) orally once every alternate day. Patients greater than 35 kg Donepezil 5 mg orally once per day. If there are no adverse effects noted on review of symptoms, the dose will be increased to 5 mg daily for patients < 35 kg. And to 10 mg/day for patients > 35 kg. This evaluation and dose escalation may be done as early as week 4. For all, donepezil will be administered 24 weeks.
463071|NCT00452868|O1|Outcome|Donepezil|
463072|NCT00452868|E1|Reported Event|Donepezil|
463073|NCT00452790|B3|Baseline|Total|Total of all reporting groups
463074|NCT00452790|B2|Baseline|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463075|NCT00452790|B1|Baseline|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463076|NCT00452790|P2|Participant Flow|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463077|NCT00452790|P1|Participant Flow|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463078|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463079|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463080|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463081|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463082|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463083|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463084|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463085|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463086|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463087|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463088|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463089|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463090|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463091|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463092|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463093|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463118|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463094|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463095|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463096|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463097|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463098|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463099|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463100|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463101|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463102|NCT00452790|O2|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 7vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463103|NCT00452790|O1|Outcome|13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series) and 12 months of age (toddler dose). During the infant series, 13vPnC was co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463104|NCT00452790|E6|Reported Event|Toddler Dose 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 12 months of age (toddler dose).
463105|NCT00452790|E5|Reported Event|Toddler Dose 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 12 months of age (toddler dose).
463106|NCT00452790|E4|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
463107|NCT00452790|E3|Reported Event|After the Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV). AEs were collected from approximately 1 month after Dose 3 to the Toddler dose.
463108|NCT00452790|E2|Reported Event|Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7vPnC, administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463109|NCT00452790|E1|Reported Event|Infant Series 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC), administered intramuscularly, at 6, 10 and 14 weeks of age (infant series), co-administered with a commercially available combination vaccine containing: diphtheria, tetanus, whole cell pertussis; H influenzae type b and hepatitis B vaccine (DTP-Hib-HBV); and a commercially available oral polio vaccine (OPV).
463110|NCT00452699|B3|Baseline|Total|Total of all reporting groups
463111|NCT00452699|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463119|NCT00452699|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463122|NCT00452699|O1|Outcome|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463123|NCT00452699|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463124|NCT00452699|E1|Reported Event|FSC DISKUS 250/50 mcg BID for 52 Weeks|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463125|NCT00452673|B5|Baseline|Total|Total of all reporting groups
463126|NCT00452673|B4|Baseline|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463127|NCT00452673|B3|Baseline|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463128|NCT00452673|B2|Baseline|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463129|NCT00452673|B1|Baseline|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463130|NCT00452673|P5|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Expansion)|No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for the dose expansion period in order to provide additional information regarding good tolerance of extended treatment. An additional 21 participants were treated in this arm in the Dose Expansion Period.
463131|NCT00452673|P4|Participant Flow|100 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463132|NCT00452673|P3|Participant Flow|70 mg Dasatinib + 1000 mg/m^2Capecitabine (Dose Escalation)|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463133|NCT00452673|P2|Participant Flow|70 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463134|NCT00452673|P1|Participant Flow|50 mg Dasatinib + 825 mg/m^2Capecitabine (Dose Escalation)|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463135|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463136|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463137|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463138|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463139|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463140|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463141|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463651|NCT00451282|E2|Reported Event|Usual Care|Injured children receiving usual care
463142|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463143|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463144|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463145|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463146|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463147|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463148|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463149|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463150|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463151|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463152|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463153|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463154|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463155|NCT00452673|O4|Outcome|100 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3A: 100 mg dasatinib oral tablet QD plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463156|NCT00452673|O3|Outcome|70 mg Dasatinib + 1000 mg/m^2Capecitabine|Dose level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463157|NCT00452673|O2|Outcome|70 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463190|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463271|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463158|NCT00452673|O1|Outcome|50 mg Dasatinib + 825 mg/m^2Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463159|NCT00452673|E4|Reported Event|100 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3A: 100 mg dasatinib oral tablet once daily (QD) plus 1000 mg/m^2 capecitabine oral tablet BID. No dose level in this study was identified as the maximum tolerated dose (MDT) but this dose arm (100 mg dasatinib plus 1000 mg/m^2 capecitabine) was selected for expansion in order to provide additional information regarding good tolerance of extended treatment.
463160|NCT00452673|E3|Reported Event|70 mg Dasatinib + 1000 mg/m^2 Capecitabine|Dose Level 3: 70 mg dasatinib oral tablet BID plus 1000 mg/m^2 capecitabine oral tablet BID.
463161|NCT00452673|E2|Reported Event|70 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 2: 70 mg dasatinib oral tablet BID plus 825 mg/m^2 capecitabine oral tablet BID.
463162|NCT00452673|E1|Reported Event|50 mg Dasatinib + 825 mg/m^2 Capecitabine|Dose Level 1: 50 milligram (mg) dasatinib oral tablet twice daily (BID) plus 825 mg per meter squared (m^2) capecitabine oral tablet BID. Participants were treated at each dose level (DL) for minimum of 21 days before accrual to the next DL. Rules for dose escalation: If 0 dose level toxicity (DLT) was observed in the first 3 participants in a cohort, the next higher cohort was opened to accrual. If 1 DLT was observed in the first 3 participants in a cohort, then 3 additional participants were studied. If 0 DLT was observed in those 3 (ie, 1 DLT in 6 subjects at the DL), the next higher cohort was opened for accrual. If >=2 DLT was observed in up to 6 subjects, then the maximum tolerated dose (MTD) was exceeded and the next lower DL was defined as the MTD. If 0 DLT was observed in 6 participants in a cohort and the next higher DL exceeded the MTD, then intermediate DLs would be studied. Once the MTD was determined, additional participants were enrolled into that dose group.
463163|NCT00452543|B3|Baseline|Total|Total of all reporting groups
463164|NCT00452543|B2|Baseline|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463165|NCT00452543|B1|Baseline|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463166|NCT00452543|P2|Participant Flow|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463167|NCT00452543|P1|Participant Flow|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463168|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463169|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463170|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463171|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463172|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463173|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463174|NCT00452543|O2|Outcome|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463175|NCT00452543|O1|Outcome|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463176|NCT00452543|E2|Reported Event|Escitalopram Plus Placebo|Escitalopram 10-30mg/day plus placebo 2 tabs tid that resembles acamprosate
463177|NCT00452543|E1|Reported Event|Escitalopram Plus Acamprosate|Escitalopram 10-30mg/day plus acamprosate 333mg, 2 tabs tid
463178|NCT00452530|B3|Baseline|Total|Total of all reporting groups
463179|NCT00452530|B2|Baseline|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463180|NCT00452530|B1|Baseline|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463181|NCT00452530|P2|Participant Flow|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463182|NCT00452530|P1|Participant Flow|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463183|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40-mg subcutaneous injection once daily (QD), plus a matching apixaban-placebo tablet 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
463184|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5-mg tablets twice daily (BID), plus a matching enoxaparin-placebo injection 12 (±3) hours prior to hip-replacement surgery through 11 (±2) days after the day of surgery.
463185|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463186|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463187|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463188|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463189|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463191|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463192|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463193|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463194|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463195|NCT00452530|O2|Outcome|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463196|NCT00452530|O1|Outcome|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463197|NCT00452530|E2|Reported Event|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
463198|NCT00452530|E1|Reported Event|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
463199|NCT00452452|B4|Baseline|Total|Total of all reporting groups
463200|NCT00452452|B3|Baseline|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
463201|NCT00452452|B2|Baseline|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
463202|NCT00452452|B1|Baseline|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463203|NCT00452452|P3|Participant Flow|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
463204|NCT00452452|P2|Participant Flow|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
463205|NCT00452452|P1|Participant Flow|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463206|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
463207|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
463208|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463209|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463210|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
463211|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
463212|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
463213|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
463214|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
463215|NCT00452452|O6|Outcome|13vPnC Group 1 - Dose 3|Participants received a third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463216|NCT00452452|O5|Outcome|13vPnC Group 2 - Dose 2|Participants 12 to < 24 months of age received a second single IM 0.5 mL doses of 13vPnC at least 56 days from the first (infant series).
463217|NCT00452452|O4|Outcome|13vPnC Group 1 - Dose 2|Participants 7 to less than (<) 12 months of age received a second single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC) at least 28 days after the first (infant series).
463218|NCT00452452|O3|Outcome|13vPnC Group 3 - Dose 1|Participants 24 to < 72 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL dose of 13vPnC (infant series).
463219|NCT00452452|O2|Outcome|13vPnC Group 2 - Dose 1|Participants 12 to < 24 months of age with 0 prior doses of Prevnar received a single IM 0.5 mL doses of 13vPnC (infant series).
463220|NCT00452452|O1|Outcome|13vPnC Group 1 - Dose 1|Participants 7 to less than (<) 12 months of age with 0 prior doses of Prevnar received a single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC)(infant series).
463221|NCT00452452|O3|Outcome|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
463714|NCT00450749|O3|Outcome|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
463222|NCT00452452|O2|Outcome|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
463223|NCT00452452|O1|Outcome|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463224|NCT00452452|E3|Reported Event|13vPnC 24 to < 72 Months of Age|Participants 24 to < 72 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a single IM 0.5 mL dose of 13vPnC.
463225|NCT00452452|E2|Reported Event|13vPnC 12 to <24 Months of Age|Participants 12 to < 24 months of age with 0 prior dose of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 2 single IM 0.5 mL doses of 13vPnC at least 56 days apart.
463226|NCT00452452|E1|Reported Event|13vPnC 7 to <12 Months of Age|Participants 7 to less than (<) 12 months of age with 0 prior doses of 7-valent pneumococcal conjugate vaccine (Prevnar) received a total of 3 single intramuscular (IM) 0.5 milliliter (mL) doses of 13-valent pneumococcal conjugate vaccine (13vPnC); the first two at least 28 days apart (infant series) and the third single IM 0.5 mL dose of 13vPnC at 12 to 16 months of age (toddler dose), at least 46 days after last infant dose.
463227|NCT00452426|B3|Baseline|Total|Total of all reporting groups
463228|NCT00452426|B2|Baseline|Current Standard of Care|Site's current standard used for delivery of sedation
463229|NCT00452426|B1|Baseline|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463230|NCT00452426|P2|Participant Flow|Current Standard of Care|Site's current standard used for delivery of sedation
463231|NCT00452426|P1|Participant Flow|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463232|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
463233|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463234|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
463235|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463236|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
463237|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463238|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
463239|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463240|NCT00452426|O2|Outcome|Current Standard of Care|Site's current standard used for delivery of sedation
463241|NCT00452426|O1|Outcome|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463242|NCT00452426|E2|Reported Event|Current Standard of Care|Site's current standard used for delivery of sedation
463243|NCT00452426|E1|Reported Event|Sedation System|Computer-Assisted Personalized Sedation (CAPS)device used for delivery of sedation
463244|NCT00452400|B6|Baseline|Total|Total of all reporting groups
463245|NCT00452400|B5|Baseline|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463246|NCT00452400|B4|Baseline|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463247|NCT00452400|B3|Baseline|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463248|NCT00452400|B2|Baseline|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463249|NCT00452400|B1|Baseline|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463250|NCT00452400|P5|Participant Flow|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463251|NCT00452400|P4|Participant Flow|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463252|NCT00452400|P3|Participant Flow|Olo 5 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463253|NCT00452400|P2|Participant Flow|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463254|NCT00452400|P1|Participant Flow|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463255|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463256|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463257|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463258|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463259|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463260|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463261|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463262|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463263|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463264|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463265|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463266|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463267|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463268|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463269|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463270|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463715|NCT00450749|O2|Outcome|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
463272|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463273|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463274|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463275|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463276|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463277|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463278|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463279|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463280|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463281|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463282|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463283|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463284|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463285|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463286|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463287|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463288|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463289|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463290|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463291|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463292|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463293|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463294|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463295|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463296|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463297|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463298|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463299|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463300|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463301|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463302|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463303|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463304|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463305|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463306|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463307|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463308|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463309|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463310|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463311|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463312|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463313|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463314|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463315|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463316|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463317|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463318|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463319|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463320|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463321|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463322|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463323|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463324|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463325|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463326|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463327|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463328|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463329|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463330|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463331|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463332|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463333|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463334|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463335|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463336|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463337|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463338|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463339|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463340|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463341|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463342|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463343|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463344|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463345|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463346|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463347|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463348|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463349|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463350|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463351|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463352|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463353|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463354|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463355|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463356|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463357|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463358|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463359|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463360|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463361|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463362|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463363|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463364|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463365|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463366|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463367|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463368|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463369|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463370|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463371|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463372|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463373|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463374|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463375|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463376|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463377|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463378|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463379|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463380|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463381|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463382|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463383|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463384|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463385|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463386|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463387|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463388|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463389|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463390|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463391|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463392|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463393|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463394|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463395|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463396|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463397|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463398|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463399|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463400|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463401|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463402|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463403|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463404|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463405|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463406|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463407|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463408|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463409|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463410|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463411|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463412|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463413|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463414|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463415|NCT00452400|O5|Outcome|Olo 20 mcg qd|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463416|NCT00452400|O4|Outcome|Olo 10 mcg qd|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463417|NCT00452400|O3|Outcome|Olo 5 mcg qd|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463418|NCT00452400|O2|Outcome|Olo 2 mcg qd|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463419|NCT00452400|O1|Outcome|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463420|NCT00452400|E5|Reported Event|Olo 20 mcg|Olodaterol 20 mcg qd (morning) delivered by the Respimat Inhaler.
463421|NCT00452400|E4|Reported Event|Olo 10 mcg|Olodaterol 10 mcg qd (morning) delivered by the Respimat Inhaler.
463422|NCT00452400|E3|Reported Event|Olo 5 mcg|Olodaterol 5 mcg qd (morning) delivered by the Respimat Inhaler.
463423|NCT00452400|E2|Reported Event|Olo 2 mcg|Olodaterol 2 mcg qd (morning) delivered by the Respimat Inhaler.
463424|NCT00452400|E1|Reported Event|Placebo|Matching Placebo delivered by the Respimat Inhaler.
463425|NCT00452387|B1|Baseline|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463426|NCT00452387|P1|Participant Flow|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463427|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463428|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463429|NCT00452387|O2|Outcome|Imaging Response (Unfavorable)|
463430|NCT00452387|O1|Outcome|Imaging Response (Favorable)|
463431|NCT00452387|O1|Outcome|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463432|NCT00452387|E1|Reported Event|Treatment Group: Mitoxantrone, Prednisone, Plus Sorafenib|The treatment plan for all subjects was mitoxantrone 12 mg/m2 IV every 21 days; sorafenib 400 mg po bid daily; and prednisone 5 mg po bid daily.
463433|NCT00452374|B1|Baseline|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
463434|NCT00452374|P1|Participant Flow|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
463435|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
463436|NCT00452374|O1|Outcome|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
463437|NCT00452374|E1|Reported Event|Oxaliplatin, Fludarabine, Cytarabine + Rituximab|Starting dose oxaliplatin 17.5mg/m^2/day intravenous (IV) for 4 days; Fludarabine 30 mg/m^2 IV and Cytarabine 1 g/m^2 IV for two days, + Rituximab 375 mg/m^2 IV on Day 3, Cycle 1 then Day 1 following cycles.
463438|NCT00452361|B3|Baseline|Total|Total of all reporting groups
463652|NCT00451282|E1|Reported Event|Intervention|Injured children receiving Stepped Preventive Care intervention
463439|NCT00452361|B2|Baseline|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463440|NCT00452361|B1|Baseline|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463441|NCT00452361|P2|Participant Flow|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463442|NCT00452361|P1|Participant Flow|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463443|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463444|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463445|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463446|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463447|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463448|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463510|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463511|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463653|NCT00451204|B3|Baseline|Total|Total of all reporting groups
463449|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463450|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463451|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463452|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463453|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463454|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463455|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463456|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463457|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463458|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463512|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463513|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463514|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463459|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463460|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463461|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463462|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463463|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463464|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463465|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463466|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463467|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463468|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463515|NCT00452335|O2|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463516|NCT00452335|O1|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463517|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463469|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463470|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463471|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463472|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463473|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463474|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463475|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463476|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463477|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463478|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463518|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463519|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463520|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463479|NCT00452361|O2|Outcome|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463480|NCT00452361|O1|Outcome|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463481|NCT00452361|E2|Reported Event|Calcineurin Inhibitor (CI)|Patients will continue to receive a CI (tacrolimus or CsA). At the discretion of the investigator, patients will be permitted to: (a) change from MMF/MPS to AZA or vice versa, and from CsA to tacrolimus or vice versa; (b) continue MMF/MPS or AZA for the entire 104-week period of randomized therapy; or (c) discontinue MMF/MPS or AZA and subsequently restart either one after discontinuation. Whole blood CsA or tacrolimus trough concentrations will be monitored at designated intervals and the CI dose adjusted to maintain the following trough concentration ranges: CsA 50-250 ng/mL and Tacrolimus 4-10 ng/mL.
463482|NCT00452361|E1|Reported Event|Sirolimus (SRL)|SRL added to the immunosuppressive regimen at a daily maintenance dose of 2 mg, following a loading dose of 6 mg. The dose of SRL adjusted as necessary to maintain a whole blood trough concentration range of 10 to 15 ng/mL. CI dose was reduced by 50% and discontinued within 2 weeks if SRL at the target trough level. Once SRL trough level was at target range, MMF dose reduced to a maximum of 1500 mg/day or MPS dose reduced to a maximum of 1080 mg/day and AZA dose reduced to a maximum of 75 mg/day. Corticosteroids were administered according to local practice, within a daily maintenance dosage range (2.5 to 15 mg for prednisone or prednisolone; 2 to 12 mg/day for methylprednisolone) or the alternate day equivalent.
463483|NCT00452348|B3|Baseline|Total|Total of all reporting groups
463484|NCT00452348|B2|Baseline|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463485|NCT00452348|B1|Baseline|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463486|NCT00452348|P2|Participant Flow|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463487|NCT00452348|P1|Participant Flow|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463488|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463489|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463490|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463491|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463492|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463493|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463494|NCT00452348|O2|Outcome|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463495|NCT00452348|O1|Outcome|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463496|NCT00452348|E2|Reported Event|FP DISKUS 250 mcg BID for 52 Weeks|Fluticasone Propionate (FP) DISKUS 250 mcg BID for 52 weeks
463497|NCT00452348|E1|Reported Event|FSC DISKUS 250/50 mcg BID|Fluticasone Propionate/Salmeterol DISKUS Combination Product (FSC) 250/50 micrograms (mcg) twice daily (BID) for 52 weeks
463498|NCT00452335|B4|Baseline|Total|Total of all reporting groups
463499|NCT00452335|B3|Baseline|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
463500|NCT00452335|B2|Baseline|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463501|NCT00452335|B1|Baseline|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463502|NCT00452335|P3|Participant Flow|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
463503|NCT00452335|P2|Participant Flow|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463504|NCT00452335|P1|Participant Flow|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463505|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463506|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463507|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463508|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463509|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463521|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463522|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463523|NCT00452335|O3|Outcome|24 Mch BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463524|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463525|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463526|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463527|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463528|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463529|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463530|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463531|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463532|NCT00452335|O3|Outcome|24 mcg BID|Adolescents (12-17 years of age)and children (6-11 years of age) who are ≥36 kg body weight
463533|NCT00452335|O2|Outcome|12 mcg BID|Up to 24 adolescents (12-17 years of age) and all children (6-11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463534|NCT00452335|O1|Outcome|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463535|NCT00452335|E3|Reported Event|24 mcg BID|Adolescents (12–17 years of age)and children (6–11 years of age) who are ≥36 kg body weight
463536|NCT00452335|E2|Reported Event|12 mcg BID|Up to 24 adolescents (12–17 years of age) and all children (6–11 years of age) who are at least 24 kg, but less than 36 kg, body weight
463537|NCT00452335|E1|Reported Event|12 mcg QD|Children (6-11 years of age) who are at least 12 kg, but less than 24 kg, body weight, and young children (<6 years of age and able to swallow capsules) who are at least 12 kg body weight
463538|NCT00452114|B3|Baseline|Total|Total of all reporting groups
463539|NCT00452114|B2|Baseline|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
463540|NCT00452114|B1|Baseline|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
463541|NCT00452114|P2|Participant Flow|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
463542|NCT00452114|P1|Participant Flow|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
463543|NCT00452114|O2|Outcome|Particpants in the Control Group (Flutter Device)|
463544|NCT00452114|O1|Outcome|Participants in the Intervention Group (Cough In-exsufflator)|
463545|NCT00452114|E2|Reported Event|Flutter Valve Device|flutter valve device delivers expiratory low-pressure vibratory pulse to the patient's airway when used daily
463546|NCT00452114|E1|Reported Event|In-Exsufflator Cough Assist Device|In-Exsufflator Cough Assist Device augments the expiratory flow and force of the patient's cough with the addition of a cycle of positive and negative inspiratory pressure when used daily
463547|NCT00451958|B5|Baseline|Total|Total of all reporting groups
463548|NCT00451958|B4|Baseline|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463549|NCT00451958|B3|Baseline|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463550|NCT00451958|B2|Baseline|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463631|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463632|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
463551|NCT00451958|B1|Baseline|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463552|NCT00451958|P5|Participant Flow|Leuprolide 7.5 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~When the main CS21 study was completed these patients were switched to treatment with degarelix 80 mg or 160 mg in the CS21A study."
463553|NCT00451958|P4|Participant Flow|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463554|NCT00451958|P3|Participant Flow|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463555|NCT00451958|P2|Participant Flow|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463556|NCT00451958|P1|Participant Flow|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 of the CS21 study (NCT00295750) as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the CS21 study and the current CS21A study.
463557|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463558|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463559|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463560|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463561|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463633|NCT00451451|E5|Reported Event|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463634|NCT00451451|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
463562|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463563|NCT00451958|O2|Outcome|Leuprolide 7.5 mg/ Degarelix 240/160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463564|NCT00451958|O1|Outcome|Leuprolide 7.5 mg/ Degarelix 240/80 mg|"During the main CS21 study (NCT00295750), leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463565|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Leuprolide participants who dropped out during the first year (i.e. during CS21) were all attributed to what became the leuprolide 7.5 mg / degarelix 160 mg arm.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463566|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463567|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463568|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463569|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463570|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463571|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463572|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463635|NCT00451451|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463713|NCT00450749|P1|Participant Flow|Arm I Placebo|Placebo once daily for 4-7 weeks.
463573|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463574|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463575|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463576|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463577|NCT00451958|O4|Outcome|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463578|NCT00451958|O3|Outcome|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463579|NCT00451958|O2|Outcome|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463580|NCT00451958|O1|Outcome|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463581|NCT00451958|E4|Reported Event|Leuprolide 7.5 mg / Degarelix 160 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463582|NCT00451958|E3|Reported Event|Leuprolide 7.5 mg / Degarelix 80 mg|"During the main CS21 study, leuprolide (Lupron Depot) 7.5 mg was injected into the muscle every 28 days for one year.~Starting one year after the first dose of leuprolide, degarelix doses were administered into the abdominal wall every 28 days. First, a starting dose of 240 mg (40 mg/mL) degarelix was administered as two 3 mL subcutaneous (s.c.) injections and one month later the participants received either subsequent monthly degarelix maintenance doses of 80 mg (20 mg/mL) or 160 mg (40 mg/mL) every 28 days for the rest of the study.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463583|NCT00451958|E2|Reported Event|Degarelix 160 mg / Degarelix 160 mg|"The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent monthly degarelix maintenance dose of 160 mg (40 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days.~Following the implementation of a protocol amendment, all patients received a monthly degarelix maintenance dose of 80 mg (20 mg/mL) for the rest of the study."
463584|NCT00451958|E1|Reported Event|Degarelix 80 mg / Degarelix 80 mg|The degarelix doses were administered into the abdominal wall every 28 days. A starting dose of 240 mg (40 mg/mL) degarelix was administered on Day 0 as two 3 mL subcutaneous (s.c.) injections. The subsequent doses of 80 mg (20 mg/mL) degarelix were administered as single 4 mL s.c. injections every 28 days for the rest of the study.
463636|NCT00451451|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463585|NCT00451906|B1|Baseline|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463586|NCT00451906|P1|Participant Flow|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463587|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463588|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463589|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463590|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463591|NCT00451906|O1|Outcome|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463637|NCT00451451|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
463638|NCT00451282|B3|Baseline|Total|Total of all reporting groups
463639|NCT00451282|B2|Baseline|Usual Care|Injured children receiving usual care
463640|NCT00451282|B1|Baseline|Intervention|Injured children receiving Stepped Preventive Care intervention
463641|NCT00451282|P2|Participant Flow|Usual Care|Injured children receiving usual care
463642|NCT00451282|P1|Participant Flow|Intervention|Injured children receiving Stepped Preventive Care intervention
463592|NCT00451906|E1|Reported Event|Bevacizumab + Chemotherapy|Eligible participants with advanced or recurrent non-squamous non-small cell lung cancer (NSCLC) were administered bevacizumab infusions at a dose of 7.5 milligram per kilogram (mg/kg) or 15 mg/kg (investigator’s choice) on Day 1 and then every 3 weeks, intravenously (IV) for a maximum of 6 cycles in combination with the standard of care NSCLC first-line chemotherapy in line with the licensed national prescribing information, during the treatment period. The initial dose of bevacizumab was to be administered following chemotherapy; all subsequent doses could be given before or after chemotherapy. After the end of chemotherapy participants without disease progression could continue bevacizumab as maintenance therapy until confirmed disease progression, unacceptable toxicity or participant consent withdrawal. Participants were followed-up through a final-visit (28 days after last bevacizumab infusion) and then every 3 months until death.
463593|NCT00451698|B3|Baseline|Total|Total of all reporting groups
463594|NCT00451698|B2|Baseline|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
463595|NCT00451698|B1|Baseline|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
463596|NCT00451698|P2|Participant Flow|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
463597|NCT00451698|P1|Participant Flow|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
463598|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
463599|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
463600|NCT00451698|O2|Outcome|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
463601|NCT00451698|O1|Outcome|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
463602|NCT00451698|E2|Reported Event|Acyanotic Study Drug|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% - Received study drug
463603|NCT00451698|E1|Reported Event|Acyanotic Placebo|Children requiring cardiac surgery with cardiopulmonary bypass with baseline saturations greater than 88% _ Received placebo
463604|NCT00451451|B5|Baseline|Total|Total of all reporting groups
463605|NCT00451451|B4|Baseline|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463606|NCT00451451|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463607|NCT00451451|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463608|NCT00451451|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
463609|NCT00451451|P4|Participant Flow|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463610|NCT00451451|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463611|NCT00451451|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463612|NCT00451451|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
463613|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463614|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463615|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463616|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
463617|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463618|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463619|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463620|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
463621|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463622|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463623|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463624|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
463625|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463626|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463627|NCT00451451|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
463628|NCT00451451|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
463629|NCT00451451|O4|Outcome|Glatiramer Acetate (GA) 20 mg Injection Once Daily (QD)|Participants received Glatiramer acetate (GA) 20 mg subcutaneous injection once daily (QD)
463630|NCT00451451|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
463654|NCT00451204|B2|Baseline|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
463655|NCT00451204|B1|Baseline|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463656|NCT00451204|P2|Participant Flow|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
463657|NCT00451204|P1|Participant Flow|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463658|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
463659|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463660|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo capsule, once a day, treatment duration is 2 years
463661|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463662|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
463663|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463664|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
463665|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463666|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once per day, treatment duration is 2 years
463667|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463668|NCT00451204|O2|Outcome|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
463669|NCT00451204|O1|Outcome|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463670|NCT00451204|E2|Reported Event|Placebo Capsules Plus Copaxone Injections|Placebo: Placebo capsule, once a day, treatment duration is 2 years
463671|NCT00451204|E1|Reported Event|Estriol Capsules Plus Copaxone Injections|Estriol: Estriol 8 mg capsule, once per day, duration of treatment is 2 years
463672|NCT00451191|B3|Baseline|Total|Total of all reporting groups
463673|NCT00451191|B2|Baseline|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463674|NCT00451191|B1|Baseline|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463675|NCT00451191|P2|Participant Flow|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463676|NCT00451191|P1|Participant Flow|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463677|NCT00451191|O2|Outcome|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463678|NCT00451191|O1|Outcome|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463679|NCT00451191|E2|Reported Event|300 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463680|NCT00451191|E1|Reported Event|100 Units Botulinum Toxin Type A|botulinum toxin type A (BoNT/A) : 100 unit and 300 unit dosages: Dilute each 100 U vial with 1.3 ml of normal saline. Each reconstituted vial is then drawn up into a single syringe with a total of 4 ml = 300 U. The instrument used to inject the botulinum toxin is an ultrasound device with a transrectal ultrasound probe specially designed for prostate biopsies which has a special canal to introduce and direct a needle in to the selected prostatic area.
463681|NCT00451048|B1|Baseline|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
463682|NCT00451048|P1|Participant Flow|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
463683|NCT00451048|O1|Outcome|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
463684|NCT00451048|E1|Reported Event|Arm I|"Patients will receive sunitinib by mouth once a day. Treatment may continue for as long as benefit is shown.~sunitinib malate: Given orally"
463685|NCT00450866|B1|Baseline|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463686|NCT00450866|P2|Participant Flow|Epothilone B (Group B)|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463687|NCT00450866|P1|Participant Flow|Epothilone B (Group A)|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463688|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463689|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463690|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463691|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463692|NCT00450866|O1|Outcome|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463693|NCT00450866|O2|Outcome|Epothilone B: Group B|Group B: an exploratory cohort of patients, with either leptomeningeal metastases (LMD) or unirradiated, asymptomatic brain metastasis from breast cancer (BCBM).Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463694|NCT00450866|O1|Outcome|Epothilone B: Group A|Group A: Patients with progressive, radiographically measurable parenchymal brain metastases after whole brain radiation therapy (WBRT). Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463695|NCT00450866|E1|Reported Event|Epothilone B (Groups A and B)|Epothilone B : Patupilone will be administered as a single intravenous infusion over 20 minutes, once every 3 weeks. Patupilone will be administered at a dose of 10 mg/m2 (q3weeks) with actual body weight.
463696|NCT00450801|B1|Baseline|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
463697|NCT00450801|P1|Participant Flow|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
463698|NCT00450801|O3|Outcome|Thalidomide Therapy|Number of patients experiencing adverse events during Thalidomide maintenance therapy.
463699|NCT00450801|O2|Outcome|R-IVAM Cycles|Number of patients experiencing adverse events during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
463700|NCT00450801|O1|Outcome|R-MACLO Cycles|Number of patients experiencing adverse events during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
463701|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
463702|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
463703|NCT00450801|O1|Outcome|R-MACLO-IVAM-T|Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (cycle 1), followed by Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (cycle 2). These two cycles are repeated once, and patients achieving complete repose receive maintenance Thalidomide.
463704|NCT00450801|E3|Reported Event|Thalidomide Therapy|Adverse Events occurring during Thalidomide maintenance therapy.
463705|NCT00450801|E2|Reported Event|R-IVAM Cycles|Adverse Events occurring during the Rituximab, Ifosfamide (and Mesna), Etoposide and Cytarabine (R-IVAM) treatment cycles.
463706|NCT00450801|E1|Reported Event|R-MACLO Cycles|Adverse Events occurring during the combination Rituximab, Methotrexate, Doxorubicin, Cyclophosphamide and Vincristine (R-MACLO) treatment cycles.
463707|NCT00450749|B4|Baseline|Total|Total of all reporting groups
463708|NCT00450749|B3|Baseline|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
463709|NCT00450749|B2|Baseline|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
463710|NCT00450749|B1|Baseline|Arm I Placebo|Placebo once daily for 4-7 weeks.
463711|NCT00450749|P3|Participant Flow|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
463712|NCT00450749|P2|Participant Flow|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
463716|NCT00450749|O1|Outcome|Arm I Placebo|Placebo once daily for 4-7 weeks.
463717|NCT00450749|E3|Reported Event|Arm III High-Dose Lycopene|60 mg/day oral Lycopene for 4-7 weeks.
463718|NCT00450749|E2|Reported Event|Arm II Low Dose Lycopene|30 mg/day oral Lycopene for 4-7 weeks.
463719|NCT00450749|E1|Reported Event|Arm I Placebo|Placebo once daily for 4-7 weeks.
463720|NCT00450723|B1|Baseline|Single Arm|
463721|NCT00450723|P1|Participant Flow|Sentinel Lymph Node Biopsy|
463722|NCT00450723|O1|Outcome|Sentinel Lymph Node BIopsy|
463723|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
463724|NCT00450723|O1|Outcome|Sentinel Lymph Node Biopsy|
463725|NCT00450723|E1|Reported Event|Single Arm|
463726|NCT00450658|B3|Baseline|Total|Total of all reporting groups
463727|NCT00450658|B2|Baseline|Ibuprofen|Ibuprofen 800mg
463728|NCT00450658|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463729|NCT00450658|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
463730|NCT00450658|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg tablets t.i.d.
463731|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463732|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463733|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463734|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463735|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463736|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463737|NCT00450658|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463738|NCT00450658|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463739|NCT00450658|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
463740|NCT00450658|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/Famotidine 26.6mg
463741|NCT00450619|B3|Baseline|Total|Total of all reporting groups
463742|NCT00450619|B2|Baseline|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463743|NCT00450619|B1|Baseline|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463744|NCT00450619|P2|Participant Flow|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463745|NCT00450619|P1|Participant Flow|Arm A- EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463746|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463747|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463748|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463749|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463750|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463751|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463752|NCT00450619|O1|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463753|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463777|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463838|NCT00450333|B1|Baseline|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463754|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463755|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463756|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463757|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463758|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463759|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463760|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463761|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463762|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463763|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463764|NCT00450619|O2|Outcome|Arm B - 153Sm-EDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463765|NCT00450619|O1|Outcome|Arm A - EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463766|NCT00450619|E2|Reported Event|Arm B - 153SmEDTMP With Vaccine|Patients receive recombinant vaccinia-TRICOM vaccine 2 x 10^8 PFU subcutaneously (SC) on day 1. Patients also receive recombinant fowlpox-TRICOM vaccine 1 x 10^9 PFU SC on days 15 and 29 and sargramostim (GM-CSF) 100 mcg/injection SC x 4 days. Treatment with recombinant fowlpox-TRICOM vaccine and GM-CSF* repeats every 4 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg as in arm I.
463767|NCT00450619|E1|Reported Event|Arm A -EDTMP Alone|Patients receive samarium Sm 153 lexidronam pentasodium 1 mCi/Kg intravenous (IV) over 1 minute on day 8. Treatment repeats every 12 weeks in the absence of disease progression or unacceptable toxicity.
463768|NCT00450580|B3|Baseline|Total|Total of all reporting groups
463769|NCT00450580|B2|Baseline|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463770|NCT00450580|B1|Baseline|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463771|NCT00450580|P2|Participant Flow|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463772|NCT00450580|P1|Participant Flow|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463773|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463774|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463775|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463776|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463871|NCT00450242|B2|Baseline|Placebo Cream|
463778|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463779|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463780|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463781|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463782|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463783|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463784|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463785|NCT00450580|O2|Outcome|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463786|NCT00450580|O1|Outcome|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463787|NCT00450580|E2|Reported Event|FPV/RTV 700/100 mg BID + ABC/3TC FDC 600/300 mg QD|FPV/RTV 700 mg/100 mg twice daily administered with ABC/3TC FDC 600/300 mg once daily
463788|NCT00450580|E1|Reported Event|FPV/RTV 1400/100 mg Once Daily (QD) + ABC/3TC FDC 600/300 mg Q|Fosamprenavir (FPV)/ritonavir (RTV) 1400 mg/100 mg once daily administered with abacavir/lamivudine fixed dose combination (ABC/3TC FDC) 600/300 mg once daily
463789|NCT00450437|B3|Baseline|Total|Total of all reporting groups
463790|NCT00450437|B2|Baseline|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463791|NCT00450437|B1|Baseline|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined) conjugate vaccine was administered intramuscularly.
463792|NCT00450437|P4|Participant Flow|Licensed Meningococcal Vaccine (19 to 55 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
463793|NCT00450437|P3|Participant Flow|Novartis MenACWY Vaccine (19 to 55 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
463794|NCT00450437|P2|Participant Flow|Licensed Meningococcal Vaccine (11 to 18 Years)|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine (supplied as a single 0.5 mL injection) was administered intramuscularly.
463795|NCT00450437|P1|Participant Flow|Novartis MenACWY Vaccine (11 to 18 Years)|One dose of the Novartis meningococcal ACWY conjugate vaccine (obtained by extemporaneous mixing of components before injection) was administered intramuscularly.
463796|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463797|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463798|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463799|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463800|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463801|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463802|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463803|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463804|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the meningococcal ACWY Lot 3 conjugate vaccine was administered intramuscularly.
463805|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the meningococcal ACWY Lot 2 conjugate vaccine was administered intramuscularly.
463806|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the meningococcal ACWY Lot 1 conjugate vaccine was administered intramuscularly.
463807|NCT00450437|O2|Outcome|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463808|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463809|NCT00450437|O2|Outcome|Licensed Meninogcoccal Vaccine|One vaccination of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly.
463810|NCT00450437|O1|Outcome|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY (three lots combined)conjugate vaccine was administered intramuscularly.
463811|NCT00450437|O3|Outcome|Novartis MenACWY Lot 3|One dose of the Novartis meningococcal ACWY Lot 3 vaccine was administered intramuscularly.
463812|NCT00450437|O2|Outcome|Novartis MenACWY Lot 2|One dose of the Novartis meningococcal ACWY Lot 2 vaccine was administered intramuscularly.
463813|NCT00450437|O1|Outcome|Novartis MenACWY Lot 1|One dose of the Novartis meningococcal ACWY conjugate Lot 1 vaccine was administered intramuscularly.
463814|NCT00450437|E2|Reported Event|Licensed Meningococcal Vaccine|One dose of the licensed meningococcal ACWY polysaccharide-protein conjugate vaccine was administered intramuscularly, 11 to 55 years of age.
463815|NCT00450437|E1|Reported Event|Novartis MenACWY Vaccine|One dose of the Novartis meningococcal ACWY conjugate vaccine (three lots combined) was administered intramuscularly, 11 to 55 years of age.
463816|NCT00450424|B3|Baseline|Total|Total of all reporting groups
463817|NCT00450424|B2|Baseline|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
463818|NCT00450424|B1|Baseline|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
463819|NCT00450424|P2|Participant Flow|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor.
463820|NCT00450424|P1|Participant Flow|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
463821|NCT00450424|O2|Outcome|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
463822|NCT00450424|O1|Outcome|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
463823|NCT00450424|E2|Reported Event|CD-ROM Condition|Participants who are randomized to the CD-ROM condition will complete the baseline interview and then meet with the health educator who will provide the participant with the standard MSI consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. Next, the participant will be provided with the CD-ROM to view on a laptop computer in the clinic. Participants will also be given a copy of the CD-ROM to take home and keep for future reference. The CD-ROM patients will sign (or not sign, if they do not consent or wish to think further about the decision) the consent form after this discussion.
463824|NCT00450424|E1|Reported Event|Standard Consent Condition|Participants in the Standard consent condition will complete the baseline interview and then meet with the study health educator who will provide the participant with the standard MSI informed consent form and provide a brief, standardized explanation of the MSI test. At that time, the participant can ask any questions s/he wishes to ask. The patients will either sign (or not sign, if they do not consent to have the test, or wish to think further about the decision) after this discussion. Participants who have further questions will be referred to either the attending physician or the genetics counselor at each hospital site.
463825|NCT00450372|B1|Baseline|Single Arm|
463826|NCT00450372|P1|Participant Flow|Single Arm|
463827|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
463828|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
463829|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without ASS expression in tumor
463830|NCT00450372|O1|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with ASS expression present in tumor
463831|NCT00450372|O2|Outcome|ADI-PEG 20: Argininosuccinate Synthetase Negative (ASS-)|Patients without Argininosuccinate Synthetase (ASS) expression present in tumor
463832|NCT00450372|O1|Outcome|ADI-PED 20: Argininosuccinate Synthetase Positive (ASS+)|Patients with Argininosuccinate Synthetase (ASS) expression present in tumor
463833|NCT00450372|E1|Reported Event|Single Arm|
463834|NCT00450333|B5|Baseline|Total|Total of all reporting groups
463835|NCT00450333|B4|Baseline|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463836|NCT00450333|B3|Baseline|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463837|NCT00450333|B2|Baseline|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463839|NCT00450333|P4|Participant Flow|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463840|NCT00450333|P3|Participant Flow|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463841|NCT00450333|P2|Participant Flow|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463842|NCT00450333|P1|Participant Flow|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463843|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463844|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463845|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463846|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463847|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463848|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463849|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463850|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463851|NCT00450333|O4|Outcome|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463852|NCT00450333|O3|Outcome|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463853|NCT00450333|O2|Outcome|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463854|NCT00450333|O1|Outcome|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463855|NCT00450333|E4|Reported Event|Dynepo QW|EPO stable subjects receiving Epoetin delta once weekly (QW)
463856|NCT00450333|E3|Reported Event|Dynepo Once Every 2 Weeks (Q2W)|EPO stable subjects receiving Epoetin delta once every 2 weeks (Q2W)
463857|NCT00450333|E2|Reported Event|Dynepo-naive Twice-weekly (BIW)|EPO-naive subjects receiving Epoetin delta twice weekly (BIW)
463858|NCT00450333|E1|Reported Event|Dynepo (Epoetin Delta)-Naive Once-weekly (QW)|Erythropoietin(EPO)-naive subjects receiving Epoetin delta once weekly (QW)
463859|NCT00450294|B1|Baseline|Longitudinal Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
463860|NCT00450294|P1|Participant Flow|Longitudinal Study Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.Measurement of Central venous pressure at event intervals during abdominal aortic aneurysm repair. Data are presented as mean +/- standard error.
463861|NCT00450294|O1|Outcome|Longitudinal Study Group|This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair.
463862|NCT00450294|O1|Outcome|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
463863|NCT00450294|E1|Reported Event|Longitudinal Group|This study is an OBSERVATIONAL STUDY. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
463864|NCT00450255|B1|Baseline|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463865|NCT00450255|P1|Participant Flow|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463866|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463867|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463868|NCT00450255|O1|Outcome|Arm I|"Patients receive Aflibercept IV at 4 mg/kg 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463869|NCT00450255|E1|Reported Event|Arm I|"Patients receive Aflibercept IV at 4 mg/kg over 1 hour on day 1. Treatment repeats every 14 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
463870|NCT00450242|B3|Baseline|Total|Total of all reporting groups
463872|NCT00450242|B1|Baseline|5% Lidocaine Cream|5% topical lidocaine cream.
463873|NCT00450242|P2|Participant Flow|Placebo Cream|
463874|NCT00450242|P1|Participant Flow|5% Lidocaine Cream|5% topical lidocaine cream.
463875|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
463876|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
463877|NCT00450242|O2|Outcome|Placebo Cream|topical cream vehicle.
463878|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
463879|NCT00450242|O2|Outcome|Placebo Cream|
463880|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
463881|NCT00450242|O2|Outcome|Placebo Cream|Topical cream vehicle.
463882|NCT00450242|O1|Outcome|5% Lidocaine Cream|5% topical lidocaine cream.
463883|NCT00450242|E2|Reported Event|Placebo Cream|
463884|NCT00450242|E1|Reported Event|5% Lidocaine Cream|5% topical lidocaine cream.
463885|NCT00450216|B3|Baseline|Total|Total of all reporting groups
463886|NCT00450216|B2|Baseline|Ibuprofen|Ibuprofen 800mg
463887|NCT00450216|B1|Baseline|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463888|NCT00450216|P2|Participant Flow|Ibuprofen|Ibuprofen 800mg tablets t.i.d.
463889|NCT00450216|P1|Participant Flow|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg tablets t.i.d.
463890|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463891|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463892|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463893|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463894|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463895|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463896|NCT00450216|O2|Outcome|Ibuprofen|Ibuprofen 800mg
463897|NCT00450216|O1|Outcome|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463898|NCT00450216|E2|Reported Event|Ibuprofen|Ibuprofen 800mg
463899|NCT00450216|E1|Reported Event|HZT-501|HZT-501: Ibuprofen 800mg/famotidine 26.6mg
463900|NCT00450112|B3|Baseline|Total|Total of all reporting groups
463901|NCT00450112|B2|Baseline|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463902|NCT00450112|B1|Baseline|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463903|NCT00450112|P2|Participant Flow|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463904|NCT00450112|P1|Participant Flow|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463905|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463906|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463907|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463908|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463909|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463910|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463911|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463912|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463913|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463914|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
464002|NCT00449696|B1|Baseline|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463915|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463916|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463917|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463918|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463919|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463920|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463921|NCT00450112|O2|Outcome|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463922|NCT00450112|O1|Outcome|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463923|NCT00450112|E2|Reported Event|1PBS1Gel-200|Patients already received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3 mL) and followed up for 13 weeks in previous study (NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
463924|NCT00450112|E1|Reported Event|2Gel-200|Patients already received 1 single dose of Gel-200 (3 mL) and followed up for 13 weeks in previous study(NCT00449696). After completion of previous study, patients entered this study and received 1 single dose of Gel-200 (3mL) intra-articular injection again into knee joint.
463925|NCT00450073|B4|Baseline|Total|Total of all reporting groups
463926|NCT00450073|B3|Baseline|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks
463927|NCT00450073|B2|Baseline|Vitamin D2|vitamin D2 50,000 IU weekly
463928|NCT00450073|B1|Baseline|Vitamin D3|vitamin D3 50,000 IU weekly
463929|NCT00450073|P3|Participant Flow|Sunlamp|Use of a sunlamp 5 times a week for 12 weeks.
463930|NCT00450073|P2|Participant Flow|Vitamin D2|vitamin D2 50,000 IU weekly
463931|NCT00450073|P1|Participant Flow|Vitamin D3|vitamin D3 50,000 IU weekly
463932|NCT00450073|O3|Outcome|Sunlamp|Weekly use of a sunlamp
463933|NCT00450073|O2|Outcome|Vitamin D2|vitamin D2 50,000 IU weekly
463934|NCT00450073|O1|Outcome|Vitamin D3|vitamin D3 50,000 IU weekly
463935|NCT00450073|E3|Reported Event|Sunlamp|Weekly use of a sunlamp
463936|NCT00450073|E2|Reported Event|Vitamin D2|vitamin D2 50,000 IU weekly
463937|NCT00450073|E1|Reported Event|Vitamin D3|vitamin D3 50,000 IU weekly
463938|NCT00449956|B4|Baseline|Total|Total of all reporting groups
463939|NCT00449956|B3|Baseline|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463940|NCT00449956|B2|Baseline|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463941|NCT00449956|B1|Baseline|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463942|NCT00449956|P3|Participant Flow|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463943|NCT00449956|P2|Participant Flow|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463944|NCT00449956|P1|Participant Flow|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463945|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463946|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463947|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463948|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463949|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463950|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463951|NCT00449956|O3|Outcome|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463952|NCT00449956|O2|Outcome|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463953|NCT00449956|O1|Outcome|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463954|NCT00449956|E3|Reported Event|Concomitant (Dorzolamide 1.0% / Timolol 0.5%)|Concomitant (Dorzolamide 1.0%, one drop per dose three times daily to the study eye / Timolol 0.5%, one drop per dose twice daily to the study eye).
463955|NCT00449956|E2|Reported Event|Timolol 0.5%|Timolol 0.5%, one drop per dose twice daily to the study eye.
463956|NCT00449956|E1|Reported Event|MK0507A (Dorzolamide 1.0% / Timolol 0.5% Combination)|MK0507A (Dorzolamide 1.0% / Timolol 0.5% combination), one drop per dose twice daily to the study eye.
463957|NCT00449930|B3|Baseline|Total|Total of all reporting groups
463958|NCT00449930|B2|Baseline|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463959|NCT00449930|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463960|NCT00449930|P2|Participant Flow|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463961|NCT00449930|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463962|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463963|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463964|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463965|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463966|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463967|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463968|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463969|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463970|NCT00449930|O2|Outcome|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463971|NCT00449930|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463972|NCT00449930|E2|Reported Event|Metformin|The Metformin group includes data from patients randomized to receive treatment with metformin initiated at a dose of 1 tablet (500 mg) per day. Patients were then to be up-titrated over a maximum of 5 weeks to a total daily dose of 2 tablets twice daily (1000 mg b.i.d).
463973|NCT00449930|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablet of sitagliptin once daily.
463974|NCT00449865|B3|Baseline|Total|Total of all reporting groups
463975|NCT00449865|B2|Baseline|Creatine|creatine 5 grams twice daily
463976|NCT00449865|B1|Baseline|Placebo|placebo: an inactive substance
463977|NCT00449865|P2|Participant Flow|Creatine|creatine monohydrate (10 gram /day)
463978|NCT00449865|P1|Participant Flow|Placebo|placebo: an inactive substance
463979|NCT00449865|O2|Outcome|Creatine|creatine monohydrate (10 grams/day)
463980|NCT00449865|O1|Outcome|Placebo|placebo: an inactive substance
463981|NCT00449865|E2|Reported Event|Creatine|creatine 5 grams twice daily
463982|NCT00449865|E1|Reported Event|Placebo|placebo: an inactive substance
463983|NCT00449787|B3|Baseline|Total|Total of all reporting groups
463984|NCT00449787|B2|Baseline|Naproxen|Naproxen 500 mg tablet
463985|NCT00449787|B1|Baseline|Sumatriptan|Sumatriptan 100 mg tablet
463986|NCT00449787|P2|Participant Flow|Naproxen|Naproxen 500 mg tablet
463987|NCT00449787|P1|Participant Flow|Sumatriptan|Sumatriptan 100 mg tablet
463988|NCT00449787|O2|Outcome|Naproxen|Naproxen 500 mg tablet
463989|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100 mg tablet
463990|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
463991|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
463992|NCT00449787|O2|Outcome|Naproxen|Naproxen 500mg tablet
463993|NCT00449787|O1|Outcome|Sumatriptan|Sumatriptan 100mg tablet
463994|NCT00449787|E2|Reported Event|Naproxen|Naproxen 500 mg tablet
463995|NCT00449787|E1|Reported Event|Sumatriptan|Sumatriptan 100 mg tablet
463996|NCT00449748|B1|Baseline|RAD001|Oral RAD001 10 mg daily for 30 days
463997|NCT00449748|P1|Participant Flow|RAD001|Oral RAD001 10 mg daily for 30 days
463998|NCT00449748|O1|Outcome|RAD001|Oral RAD001 10 mg daily for 30 days
463999|NCT00449748|E1|Reported Event|RAD001|Oral RAD001 10 mg daily for 30 days
464000|NCT00449696|B3|Baseline|Total|Total of all reporting groups
464001|NCT00449696|B2|Baseline|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464003|NCT00449696|P2|Participant Flow|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464004|NCT00449696|P1|Participant Flow|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464005|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464006|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464007|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464008|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464009|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464010|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464011|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464012|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464013|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464014|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464015|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464016|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464017|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464018|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464019|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464020|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464021|NCT00449696|O2|Outcome|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464022|NCT00449696|O1|Outcome|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464023|NCT00449696|E2|Reported Event|PBS Placebo|Patients received 1 single dose of Phosphate Buffered Saline (PBS) placebo (3mL) intra-articular injection into knee joint.
464024|NCT00449696|E1|Reported Event|Gel-200|Patients received 1 single dose of Gel-200 (3mL) intra-articular injection into knee joint.
464025|NCT00449644|B5|Baseline|Total|Total of all reporting groups
464026|NCT00449644|B4|Baseline|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464027|NCT00449644|B3|Baseline|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464028|NCT00449644|B2|Baseline|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464029|NCT00449644|B1|Baseline|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464030|NCT00449644|P4|Participant Flow|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464031|NCT00449644|P3|Participant Flow|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464032|NCT00449644|P2|Participant Flow|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464033|NCT00449644|P1|Participant Flow|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464034|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464035|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
464036|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week.
464037|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
464080|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464038|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464039|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464040|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464041|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
464042|NCT00449644|O2|Outcome|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464043|NCT00449644|O1|Outcome|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464044|NCT00449644|O2|Outcome|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464045|NCT00449644|O1|Outcome|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times a week administered as 2 tablets, and BR. Only BR after Week 8.
464046|NCT00449644|E4|Reported Event|Placebo / BR (Stage 2)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464047|NCT00449644|E3|Reported Event|TMC207 / BR (Stage 2)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 24: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 24.
464048|NCT00449644|E2|Reported Event|Placebo / BR (Stage 1)|Weeks 1 and 2: Placebo once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: Placebo three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464049|NCT00449644|E1|Reported Event|TMC207 / BR (Stage 1)|Weeks 1 and 2: 400 mg TMC207 once daily administered as 4 tablets, and Background Regimen (BR) for Multi-drug resistant tuberculosis (MDR-TB). Week 3 to 8: 200 mg TMC207 three times per week administered as 2 tablets, and BR. Only BR after Week 8.
464050|NCT00449540|B3|Baseline|Total|Total of all reporting groups
464051|NCT00449540|B2|Baseline|Sham TMS Device|Simulated Sham treatment without TMS
464052|NCT00449540|B1|Baseline|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
464053|NCT00449540|P3|Participant Flow|Sham TMS Device|Device which does not deliver TMS pulse
464054|NCT00449540|P2|Participant Flow|Active TMS|Active Transcranial Magnetic Stimulation Device
464055|NCT00449540|P1|Participant Flow|30 Day Lead in Phase|some particpants did not experience migrain in the 30 days allotted and therefore were not moved to the treatment phase
464056|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
464057|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
464058|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
464059|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
464060|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
464061|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
464062|NCT00449540|O2|Outcome|Sham TMS Device|Simulated Sham treatment without TMS
464063|NCT00449540|O1|Outcome|Active Transcranial Magnetic Stimulation (TMS) Device|Active Transcranial Magnetic Stimulation Device Treatment
464064|NCT00449540|E4|Reported Event|Sham TMS Device - Not Treatment Related|Sham TMS Device - events that are not treatment related
464065|NCT00449540|E3|Reported Event|Active TMS - Not Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Not treatment related
464066|NCT00449540|E2|Reported Event|Sham TMS Device - Treatment Related|Simulated Sham treatment without TMS
464067|NCT00449540|E1|Reported Event|Active TMS Device - Treatment Related|Active Transcranial Magnetic Stimulation Device Treatment - Treatment related
464068|NCT00449176|B4|Baseline|Total|Total of all reporting groups
464069|NCT00449176|B3|Baseline|Placebo|Matching Placebo twice daily(BID)
464070|NCT00449176|B2|Baseline|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464071|NCT00449176|B1|Baseline|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464072|NCT00449176|P3|Participant Flow|Placebo|Matching Placebo twice daily(BID)
464073|NCT00449176|P2|Participant Flow|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464074|NCT00449176|P1|Participant Flow|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464075|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464076|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464077|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464078|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464079|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464082|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464083|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464084|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464085|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464086|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464087|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464088|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464089|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464090|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464091|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464092|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464093|NCT00449176|O3|Outcome|Placebo|Matching Placebo twice daily(BID)
464094|NCT00449176|O2|Outcome|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464095|NCT00449176|O1|Outcome|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464096|NCT00449176|E3|Reported Event|Placebo|Matching Placebo twice daily(BID)
464097|NCT00449176|E2|Reported Event|Oxycodone CR|oxycodone controlled release(CR) 20-50mg twice daily(BID)
464098|NCT00449176|E1|Reported Event|Tapentadol ER|Tapentadol (CG5503) extended release(ER) 100-250mg twice daily(BID)
464099|NCT00449163|B1|Baseline|Single Arm|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464100|NCT00449163|P1|Participant Flow|Combination Chemotherapy + Bevacizumab|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464101|NCT00449163|O1|Outcome|Combination Chemotherapy + Bevacizumab|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464102|NCT00449163|O1|Outcome|Combination Chemotherapy + Bevacizumab|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464103|NCT00449163|O1|Outcome|Combination Chemotherapy + Bevacizumab|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464104|NCT00449163|E1|Reported Event|Single Arm|irinotecan hydrochloride : adjuvant therapy : neoadjuvant therapy : floxuridine : leucovorin calcium : bevacizumab :
464105|NCT00449150|B4|Baseline|Total|Total of all reporting groups
464106|NCT00449150|B3|Baseline|Placebo|Placebo on Week 0, 2 26 and 28
464107|NCT00449150|B2|Baseline|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
464108|NCT00449150|B1|Baseline|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
464109|NCT00449150|P3|Participant Flow|Placebo|Placebo on Week 0, 2 26 and 28
464110|NCT00449150|P2|Participant Flow|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
464111|NCT00449150|P1|Participant Flow|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
464112|NCT00449150|O3|Outcome|Placebo|Placebo on Week 0, 2 26 and 28
464113|NCT00449150|O2|Outcome|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
464114|NCT00449150|O1|Outcome|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
464115|NCT00449150|E3|Reported Event|Placebo|Placebo on Week 0, 2 26 and 28
464116|NCT00449150|E2|Reported Event|Cetrorelix 78+52|78+52 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 52 mg combining Week 26 (52 mg) and Week 28 (0 mg)
464117|NCT00449150|E1|Reported Event|Cetrorelix 78+78|78+78 means 78 mg combining Week 0 (52 mg) and Week 2 (26 mg) + 78 mg combining Week 26 (52 mg) and Week 28 (26 mg)
464118|NCT00449072|B3|Baseline|Total|Total of all reporting groups
464119|NCT00449072|B2|Baseline|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464120|NCT00449072|B1|Baseline|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464121|NCT00449072|P2|Participant Flow|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464122|NCT00449072|P1|Participant Flow|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464123|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464124|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464125|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464152|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464126|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464127|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464128|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464129|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464130|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464131|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464132|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464133|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464134|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464135|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464136|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464137|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464138|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464139|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464140|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464141|NCT00449072|O2|Outcome|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464142|NCT00449072|O1|Outcome|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication."
464143|NCT00449072|E2|Reported Event|TAA-AQ|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~TAA-AQ in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464144|NCT00449072|E1|Reported Event|Placebo|"3 to 9 year old participants with PAR administered~Placebo (once to demonstrate IP administration in the baseline/screening period)~Placebo in the double-blind treatment period~All participants were provided Children's Claritin® Syrup as a rescue medication"
464145|NCT00449046|B1|Baseline|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464146|NCT00449046|P1|Participant Flow|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464147|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464148|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464149|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464150|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464151|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464153|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464154|NCT00449046|O1|Outcome|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464155|NCT00449046|E1|Reported Event|Salmeterol/Fluticasone Propionate|Salmeterol/fluticasone propionate patients received 2 inhalations twice daily each inhalation was 25/50mcg for 24 weeks(Total daily dose was 100/200mcg)
464156|NCT00449033|B3|Baseline|Total|Total of all reporting groups
464157|NCT00449033|B2|Baseline|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464158|NCT00449033|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464159|NCT00449033|P2|Participant Flow|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464160|NCT00449033|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464161|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464162|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464163|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464164|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464165|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464166|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464167|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464196|NCT00448916|B2|Baseline|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464197|NCT00448916|B1|Baseline|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464168|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464169|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464170|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464171|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464172|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464173|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464174|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464175|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464176|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464177|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464178|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464179|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464180|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464181|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464182|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464183|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464184|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464185|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464186|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464187|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464188|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464189|NCT00449033|O2|Outcome|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464190|NCT00449033|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464191|NCT00449033|E2|Reported Event|Placebo + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with placebo. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: placebo 2 tablets po bid. If the patient had radiological evidence of SD or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which 2 placebo tablets were administered bid until criteria for withdrawal were met.
464192|NCT00449033|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + GC|Up to 6 cycles (21 days per cycle) of gemcitabine (G) and cisplatin (C) with sorafenib. Day 1: gemcitabine 1250 mg/ m^2 infusion (IV), followed by cisplatin 75 mg/ m^2 IV; Day 8: gemcitabine 1250 mg/ m^2 IV; Days 1-21: sorafenib 2 tablets (200 mg) taken orally (po) twice daily (bid). If the patient had radiological evidence of stable disease (SD) or better after completing up to 6 cycles in the Chemotherapy Phase, the patient could continue to Maintenance Phase, during which sorafenib was administered 400 mg bid until criteria for withdrawal were met.
464193|NCT00448916|B5|Baseline|Total|Total of all reporting groups
464194|NCT00448916|B4|Baseline|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464195|NCT00448916|B3|Baseline|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464198|NCT00448916|P4|Participant Flow|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464199|NCT00448916|P3|Participant Flow|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464200|NCT00448916|P2|Participant Flow|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464201|NCT00448916|P1|Participant Flow|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464202|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464203|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464204|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464205|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464206|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464207|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464208|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464209|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464210|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464211|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464212|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464213|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464214|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464215|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464216|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464217|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464218|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464219|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464220|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464221|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464222|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464223|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464224|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464225|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464226|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464227|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464321|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
464228|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464229|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464230|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464231|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464232|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464233|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464234|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464235|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464236|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464237|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464238|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464239|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464240|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464241|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464242|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464243|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464244|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464245|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464246|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464247|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464248|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464249|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464250|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464251|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464252|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464253|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464254|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as liquid or capsule formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day.
464255|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464256|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464257|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464258|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464322|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
464259|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464260|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464261|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464262|NCT00448916|O4|Outcome|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464263|NCT00448916|O3|Outcome|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464264|NCT00448916|O2|Outcome|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464265|NCT00448916|O1|Outcome|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464266|NCT00448916|E5|Reported Event|Overall|This arm summarizes the AE data from all the treatment groups.
464267|NCT00448916|E4|Reported Event|Pregabalin: 12-16 Years|Age group included 12-16 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464268|NCT00448916|E3|Reported Event|Pregabalin: 7-11 Years|Age group included 7-11 years. Pregabalin was administered orally as capsule formulation and liquid formulation was used if participants was unable to swallow capsules. Doses of 2.5, 5, 7.5, 10, or 15 mg/kg/day were given for 12 Months.
464269|NCT00448916|E2|Reported Event|Pregabalin: 2-6 Years|Age group included 2-6 years. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months..
464270|NCT00448916|E1|Reported Event|Pregabalin: 1-23 Months|Age group included 1-23 months. Pregabalin was administered orally as liquid formulation at dose of 2.5, 5, 7.5, 10, or 15 mg/kg/day for 12 Months.
464271|NCT00448864|B4|Baseline|Total|Total of all reporting groups
464272|NCT00448864|B3|Baseline|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464273|NCT00448864|B2|Baseline|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464274|NCT00448864|B1|Baseline|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464275|NCT00448864|P3|Participant Flow|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464276|NCT00448864|P2|Participant Flow|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464277|NCT00448864|P1|Participant Flow|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 milliliters per hour (mL/hr) for 4 hours.
464278|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464279|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464280|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464281|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464282|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464283|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464284|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464285|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464286|NCT00448864|O3|Outcome|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464287|NCT00448864|O2|Outcome|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464288|NCT00448864|O1|Outcome|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 mg ecallantide in stages. Intravenous (IV) infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464289|NCT00448864|E3|Reported Event|Placebo|Participants received placebo in stages. IV infusion placebo was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, a second infusion of placebo was started at 38 mL/hr for 4 hours.
464290|NCT00448864|E2|Reported Event|Ecallantide - High Dose Regimen|Participants received a maximum of 91 mg ecallantide in stages. IV infusion of 0.6 mg/mL ecallantide was administered at 2.92 mL/min for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of CPB, whichever came first. At the termination of the initial infusion, an infusion of normal saline was started at 38 mL/hr for 4 hours.
464291|NCT00448864|E1|Reported Event|Ecallantide - Low Dose Regimen|Participants received a maximum of 15 milligrams (mg) ecallantide in stages. Intravenous (IV) infusion of 0.6 milligrams per milliliter (mg/mL) ecallantide was administered at 2.92 milliliters per minute (mL/min) for 20 minutes. The infusion rate was then reduced to 0.583 mL/min for 160 minutes, or until the end of cardiopulmonary bypass (CPB), whichever came first. At the termination of the initial infusion, a second infusion of 0.4 mg/mL ecallantide was started at 38 mL/hr for 4 hours.
464292|NCT00448760|B1|Baseline|Single Arm|5-Fluorodeoxyuridine, Leucovorin, Oxaliplatin and Docetaxel
464293|NCT00448760|P1|Participant Flow|Neoadjuvant + Adjuvant Chemotherapy|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464294|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464295|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464296|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464297|NCT00448760|O1|Outcome|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464298|NCT00448760|E1|Reported Event|Single Arm|"Floxuridine : Intravenuosly, 110mg/kg, continuous infusion over 24 hours, 2 cycles~Leucovorin : Intravenuosly, 500mg/m2, continuous infusion over 24 hours, 2 cycles~Conventional surgery : Surgical removal of tumor for correlative studies~reverse transcriptase-polymerase chain reaction : Analysis of tumor for pathologic response to protocol therapy~Docetaxel : Intravenously, 25 mg/m2, over 30 minutes, 2 cycles~Microarray analysis : Analysis of tumor for pathologic response to protocol therapy~Oxaliplatin : Intravenously, 85 mg/m2, over 2 hours, 2 cycles"
464299|NCT00448708|B3|Baseline|Total|Total of all reporting groups
464300|NCT00448708|B2|Baseline|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
464301|NCT00448708|B1|Baseline|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
464302|NCT00448708|P2|Participant Flow|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
464303|NCT00448708|P1|Participant Flow|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
464304|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
464305|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
464306|NCT00448708|O2|Outcome|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
464307|NCT00448708|O1|Outcome|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
464308|NCT00448708|E2|Reported Event|Lifespan® ePTFE Vascular Graft|Lifespan® ePTFE Vascular Graft Only
464309|NCT00448708|E1|Reported Event|Vascular Wrap and Graft|Lifespan® ePTFE Vascular Graft and Vascular WrapTM Paclitaxel-Eluting Mesh
464310|NCT00448682|B1|Baseline|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464311|NCT00448682|P1|Participant Flow|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464312|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464313|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464314|NCT00448682|O1|Outcome|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464315|NCT00448682|E1|Reported Event|FUdR + Leucovorin + Oxaliplatin + Docetaxel|"Treatment will be administered on an outpatient basis. Chemotherapy will be administered weekly, 3 out of 4 weeks, on days 1, 8 and 15:~Day 1 and Day 15 Chemotherapy Administration: Patients will be administered oxaliplatin (85 mg/m2) and docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110 mg/kg//500 mg/m2) on Day 1 and Day 15 of each cycle.~Day 8 Chemotherapy Administration On Day 8, treatment will consist of docetaxel (25 mg/m2) followed by FUdR/Leucovorin (110mg/kg//500mg/m2).~There will be no treatment delivered week 4 (Day 22). For the purpose of this study, one cycle equals four weeks. There will be a maximum of 6 cycles."
464316|NCT00448630|B1|Baseline|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464317|NCT00448630|P1|Participant Flow|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464318|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
464319|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
464320|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
464323|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
464324|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
464325|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
464326|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
464327|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
464328|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
464329|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
464330|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
464331|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
464332|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
464333|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
464334|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
464335|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
464336|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
464337|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
464338|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
464339|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464340|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464341|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464342|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464343|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464344|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464345|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464346|NCT00448630|O7|Outcome|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
464347|NCT00448630|O6|Outcome|Amisulpride|amisulpride as prescribed by subject's physician
464348|NCT00448630|O5|Outcome|Aripiprazole|aripiprazole as prescribed by subject's physician
464349|NCT00448630|O4|Outcome|Olanzipine|olanzipine as prescribed by subject's physician
464350|NCT00448630|O3|Outcome|Quetiapine|quetiapine as prescribed by subject's physician
464351|NCT00448630|O2|Outcome|Risperidone|risperidone as prescribed by subject's physician
464352|NCT00448630|O1|Outcome|Ziprasidone|ziprasidone as prescribed by subject's physician
464353|NCT00448630|O1|Outcome|Atypical Antipsychotic Treatment|Subjects with schizophrenia treated with the atypical antipsychotic drugs ziprasidone, risperidone, quetiapine, olanzapine, aripiprazole, or amisulpride. The requirements of the study did not include inducement for any specific atypical antipsychotic drug. The most appropriate treatment for each subject was decided freely by their doctors.
464354|NCT00448630|E7|Reported Event|Other|other medications not included in the protocol-specified atypical antipsychotic groups: clozapine, haloperidol, zuclopenthixol, sertindole, and sulpiride. Treatment prescribed by subject's physician.
464355|NCT00448630|E6|Reported Event|Amisulpride|amisulpride as prescribed by subject's physician
464356|NCT00448630|E5|Reported Event|Aripiprazole|aripiprazole as prescribed by subject's physician
464357|NCT00448630|E4|Reported Event|Olanzipine|olanzipine as prescribed by subject's physician
464358|NCT00448630|E3|Reported Event|Quetiapine|quetiapine as prescribed by subject's physician
464359|NCT00448630|E2|Reported Event|Risperidone|risperidone as prescribed by subject's physician
464360|NCT00448630|E1|Reported Event|Ziprasidone|ziprasidone as prescribed by subject's physician
464361|NCT00448591|B1|Baseline|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
464525|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
464362|NCT00448591|P1|Participant Flow|Bevacizumab|Participants received bevacizumab 15 milligrams per kilogram (mg/kg) intravenously (iv) on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy or in combination with other chemotherapy as prescribed.
464363|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
464364|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
464365|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
464366|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
464367|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on day 1 of each 3 week cycle, or 10 mg/kg iv on day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
464368|NCT00448591|O1|Outcome|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) along with Taxane-based chemotherapy as prescribed
464369|NCT00448591|E1|Reported Event|Bevacizumab|Participants received bevacizumab 15 mg/kg iv on Day 1 of each 3 week cycle, or 10 mg/kg iv on Day 1 of each 2 week cycle (weekly equivalent dose of 5 mg/kg/week) until disease progression, unacceptable toxicity or withdrawal, along with Taxane-based chemotherapy as prescribed
464370|NCT00448539|B3|Baseline|Total|Total of all reporting groups
464371|NCT00448539|B2|Baseline|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464372|NCT00448539|B1|Baseline|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464373|NCT00448539|P2|Participant Flow|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464374|NCT00448539|P1|Participant Flow|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400-3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400-3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464375|NCT00448539|O2|Outcome|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464395|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464396|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464376|NCT00448539|O1|Outcome|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464377|NCT00448539|E2|Reported Event|Rufinamide (Placebo During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received placebo in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they transitioned from placebo to 3200 mg/day, beginning at 800mg/day. Upon starting the extension study,during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the double-blind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464378|NCT00448539|E1|Reported Event|Rufinamide (Rufinamide During Core Study)|Participants entered this open-label extension study from E2080-A001-301 double-blind core study, where they received rufinamide in the core study. Prior to starting the extension study, subjects completed a 12-day Transition Phase where they maintained their 2400-3200mg/day dose. Upon starting the extension study, during the 12-18 day open-label Titration Phase, subjects receiving 2400–3200mg/day from the doubleblind core study maintained this dose, and subjects who underwent dose reduction in Study E2080-A001-301 titrated from 800mg/day to 2400–3200mg/day. During the open-label Maintenance Phase (during which the maximum exposure was 2.9 years), changes in the rufinamide dose were permitted for all participants; however, the dose must have been maintained within the range of 2400 to 4800 mg/day (i.e., 1200 to 2400 mg twice daily).
464379|NCT00448448|B3|Baseline|Total|Total of all reporting groups
464380|NCT00448448|B2|Baseline|Observation|Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.
464381|NCT00448448|B1|Baseline|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Brace: Brace (TLSO) prescribed for at least 18 hours per day. Wear time measured using a temperature monitor. Orthotic evaluations are conducted every 6 months and as necessary to maintain brace fit and function."
464382|NCT00448448|P2|Participant Flow|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
464383|NCT00448448|P1|Participant Flow|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
464384|NCT00448448|O2|Outcome|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
464385|NCT00448448|O1|Outcome|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
464386|NCT00448448|E2|Reported Event|Observation|"Observation. Observed subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning.~Observation: Clinical, radiographic, and self-report follow-up every 6 months."
464387|NCT00448448|E1|Reported Event|Brace|"This study involves full-time, rigid TLSO's only. Braced subjects are followed every six months with radiography, clinical exam and self-reported evaluations of health and functioning. Orthotic evaluations are conducted every 6 months as as necessary to maintain brace fit and function.~Brace: Brace (TLSO) applied for at least 18 hours per day. Wear time measured using a temperature monitor. Clinical, radiographic, and self-report follow-up every 6 months."
464388|NCT00448435|B1|Baseline|Overall Study Population|Randomized Population
464389|NCT00448435|P2|Participant Flow|SLM 50 Mcg + FP 100 Mcg/Day First|SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
464390|NCT00448435|P1|Participant Flow|SFC 50/100 Mcg/Day First|GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).
464391|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464392|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464393|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464394|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464397|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464398|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464399|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464400|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464401|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464402|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464403|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464404|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464405|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464406|NCT00448435|O2|Outcome|SLM 50mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
464407|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464408|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464409|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464410|NCT00448435|O2|Outcome|SLM 50 Mcg + FP 100 Mcg/Day|Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
464411|NCT00448435|O1|Outcome|SFC 50/100 Mcg/Day|Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
464412|NCT00448435|E3|Reported Event|SFC 50/100mcg/Day (Extension Period)|Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
464413|NCT00448435|E2|Reported Event|SLM 50 + FP 100 Mcg/Day|Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
464414|NCT00448435|E1|Reported Event|SFC 50/100 Mcg/Day|Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10
464415|NCT00448344|B3|Baseline|Total|Total of all reporting groups
464416|NCT00448344|B2|Baseline|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
464417|NCT00448344|B1|Baseline|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
464418|NCT00448344|P2|Participant Flow|Standard Smoking Cessation|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
464419|NCT00448344|P1|Participant Flow|Family-supported Smoking Cessation|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
464420|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
464421|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
464422|NCT00448344|O2|Outcome|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
464423|NCT00448344|O1|Outcome|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
464424|NCT00448344|E2|Reported Event|Arm 2|"Standard smoking cessation~Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions"
464425|NCT00448344|E1|Reported Event|Arm 1|"Family-supported smoking cessation~Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking"
464426|NCT00448279|B3|Baseline|Total|Total of all reporting groups
464427|NCT00448279|B2|Baseline|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464526|NCT00448123|O1|Outcome|Placebo|"Placebo~Placebo: Placebo"
464428|NCT00448279|B1|Baseline|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464429|NCT00448279|P2|Participant Flow|Chemotherapy Plus (+) Trastuzumab|Participants received trastuzumab at either 2 milligrams per kilogram (mg/kg), intravenously (IV), every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464430|NCT00448279|P1|Participant Flow|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464431|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464432|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464433|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464434|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464435|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464436|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464437|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464438|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464439|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464440|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464441|NCT00448279|O2|Outcome|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464442|NCT00448279|O1|Outcome|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464473|NCT00448175|B2|Baseline|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
464527|NCT00448123|O2|Outcome|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
464528|NCT00448123|O1|Outcome|Placebo|Active placebo orally per day for up to 10 days.
464443|NCT00448279|E2|Reported Event|Chemotherapy + Trastuzumab|Participants received trastuzumab at either 2 mg/kg, IV, every 7 days, or 6 mg/kg, IV, every 3 weeks, per the investigator's discretion. Participants also received chemotherapy; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine. Study treatment was administered until disease progression, unacceptable toxicity, or death.
464444|NCT00448279|E1|Reported Event|Chemotherapy Alone|Participants received chemotherapy until disease progression, unacceptable toxicity, or death; the schedule and dose at the investigator’s discretion and per local prescribing guidelines and standard center practice. Allowed chemotherapy regimens included paclitaxel, gemcitabine, platinum compounds, docetaxel, capecitabine, or vinorelbine.
464445|NCT00448227|B1|Baseline|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464446|NCT00448227|P1|Participant Flow|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464447|NCT00448227|O4|Outcome|Total|
464448|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464449|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464450|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464451|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464452|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464453|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464454|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464455|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464456|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464457|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464458|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464459|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464460|NCT00448227|O4|Outcome|Total|
464461|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464462|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464463|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464464|NCT00448227|O4|Outcome|Total|
464465|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464466|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464467|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464468|NCT00448227|O3|Outcome|Famciclovir: Infants 6 to 12 Months|Infants 6 to 12 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464469|NCT00448227|O2|Outcome|Famciclovir: Infants 3 to <6 Months|Infants 3 to <6 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464470|NCT00448227|O1|Outcome|Famciclovir: Infants 1 to <3 Months|Infants 1 to <3 months. Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464471|NCT00448227|E1|Reported Event|Famciclovir|Famciclovir was administered orally as a suspension in OraSweet® on Day 1. Patients received a single, individualized dose between 25-200 mg based on body weight.
464472|NCT00448175|B3|Baseline|Total|Total of all reporting groups
464474|NCT00448175|B1|Baseline|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
464475|NCT00448175|P2|Participant Flow|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
464476|NCT00448175|P1|Participant Flow|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
464477|NCT00448175|O2|Outcome|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
464478|NCT00448175|O1|Outcome|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
464479|NCT00448175|E2|Reported Event|4mg Daily Tolterodine|90 day prescription for 4mg daily extended-release tolterodine tartrate (Detrol LA)
464480|NCT00448175|E1|Reported Event|Urgent PC Treatment Arm|The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).
464481|NCT00448136|B3|Baseline|Total|Total of all reporting groups
464482|NCT00448136|B2|Baseline|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464483|NCT00448136|B1|Baseline|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464484|NCT00448136|P2|Participant Flow|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, orally (PO), twice daily (BID) on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464485|NCT00448136|P1|Participant Flow|Bevacizumab + 5-fluorouracil (5-FU) + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 milligrams per kilogram (mg/kg) intravenously (IV) on Days 1 and 22; 5-FU 400 mg per square meter per day (mg/m^2/day) IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464486|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464487|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464488|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464489|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464490|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464491|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464492|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464493|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464494|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464495|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464496|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464497|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464523|NCT00448123|P2|Participant Flow|Tamsulosin|Tamsulosin orally 0.4 mg/daily for up to 10 days.
464524|NCT00448123|P1|Participant Flow|Placebo|None active placebo orally per day for up to 10 days.
464498|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464499|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464500|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464501|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464502|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464503|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464504|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464505|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464506|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464507|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464508|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464509|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464510|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464511|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464512|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464513|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464514|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464515|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464516|NCT00448136|O2|Outcome|Bevacizumab + Capecitabine|Cycles 1-9 (21-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 1000 mg/m^2, tablets, PO, BID on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464517|NCT00448136|O1|Outcome|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464518|NCT00448136|E2|Reported Event|Bevacizumab + Capecitabine|Cycles 1-9 (21-Day cycle): Participants received bevacizumab 7.5 mg/kg IV on Day 1; capecitabine 2000 mg/m^2 tablets PO in a divided dose every 12 hours within 30 minutes following a meal, on Days 1 through 14. Days 15-21 were a rest period. This 21-day cycle was repeated at least 8 times.
464519|NCT00448136|E1|Reported Event|Bevacizumab + 5-FU + Streptozocin|Cycles 1-5 (42-day cycles): Participants received bevacizumab 7.5 mg/kg IV on Days 1 and 22; 5-FU 400 mg/m^2/day IV on Days 1 through 5; and streptozocin 500 mg/m^2/day IV on Days 1 through 5. Days 5-21 and 23-42 were rest periods. This 42-day cycle was repeated at least 4 times.
464520|NCT00448123|B3|Baseline|Total|Total of all reporting groups
464521|NCT00448123|B2|Baseline|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
464522|NCT00448123|B1|Baseline|Placebo|Placebo Group
464529|NCT00448123|O2|Outcome|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
464530|NCT00448123|O1|Outcome|Placebo|Placebo Group
464531|NCT00448123|E2|Reported Event|Tamsulosin|"Intervention - Tamsulosin~Tamsulosin: Study Drug"
464532|NCT00448123|E1|Reported Event|Placebo|Placebo Group
464533|NCT00448019|B1|Baseline|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464534|NCT00448019|P1|Participant Flow|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464535|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464536|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464537|NCT00448019|O1|Outcome|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464538|NCT00448019|E1|Reported Event|FCR + Bevacizumab|FCR = Fludarabine 25 mg/m^2 intravenous (IV) , Cyclophosphamide 250 mg/m^2 IV daily for 3 days, Rituximab 375 mg/m^2 IV Day 1, followed by 500 mg/m^2 IV. FCR daily for 3 days. Bevacizumab 10 mg/Kg IV on Day 3, course 1.
464539|NCT00447902|B3|Baseline|Total|Total of all reporting groups
464540|NCT00447902|B2|Baseline|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464541|NCT00447902|B1|Baseline|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464542|NCT00447902|P2|Participant Flow|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464543|NCT00447902|P1|Participant Flow|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464544|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464545|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464546|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464547|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464548|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464549|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464550|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464551|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464552|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464553|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464554|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464555|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464556|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464557|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464558|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464559|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464560|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464561|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464562|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464563|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464564|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464565|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
465091|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
464566|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464567|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464568|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464569|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464570|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464571|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464572|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464573|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464574|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464575|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464576|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464577|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464578|NCT00447902|O2|Outcome|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464579|NCT00447902|O1|Outcome|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464580|NCT00447902|E2|Reported Event|Therapeutic Drug Monitoring|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules as initial dose, increased to TPV/r 750mg/200mg BID capsules, or decreased to TPV/r 500mg/100mg BID capsules or TPV/r 250mg/200mg BID capsules
464581|NCT00447902|E1|Reported Event|Standard of Care|Tipranavir (TPV) 500mg and Ritonavir (RTV) 200mg BID capsules
464582|NCT00447603|B1|Baseline|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
464583|NCT00447603|P3|Participant Flow|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
464584|NCT00447603|P2|Participant Flow|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
464585|NCT00447603|P1|Participant Flow|All Enrolled|Participants who met initial screening criteria for inclusion in study and were enrolled in the study.
464586|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
464587|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
464588|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464589|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464590|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
464591|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
464592|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464593|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464594|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
464595|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
464596|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464597|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464598|NCT00447603|O4|Outcome|Losartan 100 mg/HCTZ 12.5 mg|Losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg once daily for 4 weeks
464599|NCT00447603|O3|Outcome|Losartan 50 mg/HCTZ 12.5 mg|Losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg once daily for 4 weeks
465092|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
464600|NCT00447603|O2|Outcome|Losartan 100 mg|Losartan 100 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 100 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464601|NCT00447603|O1|Outcome|Losartan 50 mg|Losartan 50 mg tablet, oral, once daily for 4 weeks. Participant also will be co-administered placebo for losartan 50 mg/hydrochlorothiazide (HCTZ) 12.5 mg once daily for 4 weeks
464602|NCT00447603|E2|Reported Event|Losartan 50 Mg-100 mg (Filter Period)|Participants >=50 kg; Administered Losartan 50mg, oral, once daily for 3 weeks, then Losartan 100 mg for 3 weeks
464603|NCT00447603|E1|Reported Event|Losartan 25 Mg-50 mg (Filter Period)|Participants <50 kg; Administered Losartan 25 mg, oral, once daily for 3 weeks, then Losartan 50 mg for 3 weeks
464604|NCT00447590|B1|Baseline|LAP-BAND|All subjects who received the LAP-BAND System.
464605|NCT00447590|P1|Participant Flow|LAP-BAND|All subjects who received the LAP-BAND System.
464606|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464607|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464608|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464609|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464610|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464611|NCT00447590|O1|Outcome|LAP-BAND|All subjects who received the LAP-BAND System.
464612|NCT00447590|E1|Reported Event|LAP-BAND|All subjects who received the LAP-BAND System.
464613|NCT00447499|B1|Baseline|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464614|NCT00447499|P1|Participant Flow|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464615|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464616|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464617|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464618|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)|Somatuline Autogel (lanreotide acetate) Injection/Switch Patient
464619|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
464620|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate)/Switch Patient|
464621|NCT00447499|O1|Outcome|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464622|NCT00447499|E1|Reported Event|Somatuline Autogel (Lanreotide Acetate) Injection|Somatuline Autogel (lanreotide acetate) Deep Sub-cutaneous Injection 60 to 120 mg every 28 days
464623|NCT00447421|B1|Baseline|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464624|NCT00447421|P1|Participant Flow|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464625|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464626|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464627|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464628|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464629|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464630|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464631|NCT00447421|O1|Outcome|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464706|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464632|NCT00447421|E1|Reported Event|Pemetrexed + Cisplatin|"Phase 1: pemetrexed - 500 mg/m2 then 400 mg/m2, intravenous (IV), every 21 days x 4 cycles (dose escalation)~Phase 2: pemetrexed - 500 mg/m2 then phase 1 determined dose, IV, every 21 days x 4 cycles~Cisplatin: Phase 1 and Phase 2: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles~Radiation: Phase 1 and Phase 2: 50-62 gray (Gy), 25-31 days, cycles 2-4"
464633|NCT00447382|B3|Baseline|Total|Total of all reporting groups
464634|NCT00447382|B2|Baseline|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464635|NCT00447382|B1|Baseline|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464636|NCT00447382|P2|Participant Flow|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464637|NCT00447382|P1|Participant Flow|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464638|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464639|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464640|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464641|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464642|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464643|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464644|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464645|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464646|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464647|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464648|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464649|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464650|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464651|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464652|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464653|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464654|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464655|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464656|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464657|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
465093|NCT00446147|O1|Outcome|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
464658|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464659|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464660|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464661|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464662|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464663|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464664|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464665|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464666|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464667|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464668|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464669|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464670|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464671|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464672|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464673|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464674|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464675|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464676|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464677|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464678|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464679|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464680|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464681|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464682|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464683|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
465094|NCT00446147|E2|Reported Event|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
464684|NCT00447382|O2|Outcome|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464685|NCT00447382|O1|Outcome|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464686|NCT00447382|E2|Reported Event|NN729|Individually adjusted dosage of insulin detemir produced by the NN729 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464687|NCT00447382|E1|Reported Event|NN304|Individually adjusted dosage of insulin detemir produced by the NN304 process, administered sub-cutaneously (s.c.) 1-2 times daily + Individually adjusted dosage of insulin aspart, administered sub-cutaneously (s.c.) at meals for 52 weeks
464688|NCT00447330|B1|Baseline|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464689|NCT00447330|P1|Participant Flow|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464690|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464691|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464692|NCT00447330|O1|Outcome|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464693|NCT00447330|O1|Outcome|1- Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avastin|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464694|NCT00447330|E1|Reported Event|1 - Capecitabine (Xeloda), Oxaliplatin and Bevacizumab (Avasti|"capecitabine (Xeloda), oxaliplatin and bevacizumab (Avastin): Capecitabine will be administered orally at a twice daily dose of 850 mg/m2 (equivalent to a total daily dose of 1700 mg/m2) given days 1-14 of the three week cycle.~Oxaliplatin will be administered at the dose of 130 mg/m2 given as a 2-hour intravenous infusion on day 1 of a three week cycle.~Bevacizumab will be administered at a dose of 15 mg/kg given as a 30-90 minute intravenous infusion on day 1 of a three week cycle following the administration of oxaliplatin."
464695|NCT00447278|B3|Baseline|Total|Total of all reporting groups
464696|NCT00447278|B2|Baseline|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464697|NCT00447278|B1|Baseline|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464698|NCT00447278|P2|Participant Flow|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464699|NCT00447278|P1|Participant Flow|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464700|NCT00447278|O1|Outcome|Pearson Correlation Coefficient|Correlation Coefficient between parent-rated and patient-rated CHIP T-score domains.
464701|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464702|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464703|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464704|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464705|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464707|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464708|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464709|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464710|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464711|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464712|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464713|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464714|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464715|NCT00447278|O2|Outcome|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464716|NCT00447278|O1|Outcome|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464717|NCT00447278|E2|Reported Event|OEST|Other Early Standard Treatment (OEST): any treatment for ADHD as prescribed by investigator, 6 months, up to an additional 6 months extension
464718|NCT00447278|E1|Reported Event|Atomoxetine|0.5 mg/kg/day once a day (QD) or twice a day (BID) for 1 week then 1.2-1.8 mg/kg/day QD or BID for 6 months, up to an additional 6 months optional extension
464719|NCT00447265|B1|Baseline|Etanercept|Participant self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks. She continued receiving her usual treatment with corticosteroids and mycophenolate mofetil.
464720|NCT00447265|P2|Participant Flow|Placebo|Participants (or their caretaker) would administer 50 mg placebo subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
464721|NCT00447265|P1|Participant Flow|Etanercept|Participants (or their caretaker) would administer 50 mg etanercept subcutaneous injections once weekly for 24 weeks. They would continue receiving their usual treatment with corticosteroids and either mycophenolate mofetil or azathioprine.
464722|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464723|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464724|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464725|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464726|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464727|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464728|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464729|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464730|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464731|NCT00447265|O1|Outcome|Etanercept|Etanercept plus standard of care
464732|NCT00447265|E1|Reported Event|Etanercept|Participant received self-administered 50 mg etanercept subcutaneous injections once weekly for 24 weeks while continuing to receive her usual lupus treatment of corticosteroids and mycophenolate mofetil.
464733|NCT00447226|B1|Baseline|All Participants|All participants treated in the open-label phase (1500 milligrams [mg] lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
464734|NCT00447226|P2|Participant Flow|Lapatinib 1500 Milligrams (mg)|Lapatinib 1500 mg orally, once a day
464735|NCT00447226|P1|Participant Flow|Placebo|Identical matching placebo orally, once a day
464736|NCT00447226|O1|Outcome|All Screened Participants|All screened participants
464737|NCT00447226|O1|Outcome|Screened Participants With Gastric Cancer|Screened participants with gastric cancer
464738|NCT00447226|O1|Outcome|All Participants With Ovarian Cancer|All participants with ovarian cancer treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
464739|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day: up to end of Stage 2
464740|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day: up to end of Stage 2
464741|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day: up to end of Stage 1
464742|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
464743|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
464744|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
464745|NCT00447226|O3|Outcome|Placebo|Identical matching placebo orally, once a day
464746|NCT00447226|O2|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
464747|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 mg|Open-label lapatinib 1500 mg orally, once a day
464748|NCT00447226|O2|Outcome|Placebo|Identical matching placebo orally, once a day
464749|NCT00447226|O1|Outcome|Double-blind Lapatinib 1500 mg|Double-blind lapatinib 1500 mg orally, once a day
464750|NCT00447226|O1|Outcome|Open-label Lapatinib 1500 Milligrams (mg)|Open-label lapatinib 1500 mg orally, once a day
464751|NCT00447226|E1|Reported Event|All Participants|All participants treated in the open-label phase (1500 mg lapatinib, orally once a day), including those subsequently randomized to lapatinib (1500 mg, orally once a day) or matching placebo
464752|NCT00447122|B1|Baseline|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
465216|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
464753|NCT00447122|P1|Participant Flow|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
464754|NCT00447122|O1|Outcome|Lapatinib and Gemcitabine|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
464755|NCT00447122|E1|Reported Event|Treatment|lapatinib, 1,500 mg/day, and Gemcitabine, 1 gm/m2/week for 3 weeks followed by 1 week off, until disease progression
464756|NCT00447057|B5|Baseline|Total|Total of all reporting groups
464757|NCT00447057|B4|Baseline|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
464758|NCT00447057|B3|Baseline|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464759|NCT00447057|B2|Baseline|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464760|NCT00447057|B1|Baseline|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21-day cycle until PD or unacceptable toxicity
464761|NCT00447057|P4|Participant Flow|Pemetrexed + Erlotinib (Squamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given po, QD, starting on the first day of the first cycle"
464762|NCT00447057|P3|Participant Flow|Pemetrexed (Squamous)|Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464763|NCT00447057|P2|Participant Flow|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² iv over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally (po), daily (QD), starting on the first day of the first cycle"
464764|NCT00447057|P1|Participant Flow|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21-day cycle until disease progression or unacceptable toxicity
464765|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464766|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464767|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464768|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464769|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464770|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464771|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464772|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464773|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464774|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464775|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464776|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464777|NCT00447057|O2|Outcome|Pemetrexed + Erlotinib (Nonsquamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464778|NCT00447057|O1|Outcome|Pemetrexed (Nonsquamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464779|NCT00447057|E2|Reported Event|Pemetrexed + Erlotinib (Nonsquamous and Squamous)|"Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity~Erlotinib: 150 mg given orally, Daily, starting on the first day of the first cycle"
464780|NCT00447057|E1|Reported Event|Pemetrexed (Nonsquamous and Squamous)|Pemetrexed: 500 mg/m² intravenous (iv) over 10 minutes on the first day of each 21 day cycle until disease progression or unacceptable toxicity
464781|NCT00447005|B1|Baseline|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
465003|NCT00446199|B2|Baseline|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
464782|NCT00447005|P1|Participant Flow|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464783|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464784|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464785|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464786|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464787|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464788|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464789|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464790|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464791|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464792|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464793|NCT00447005|O1|Outcome|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464794|NCT00447005|E1|Reported Event|AG-013736|"Single dose (first 6 participants only): Single AG-013736 5 mg was administered orally.~Multiple dose (all participants): AG-013736 5 mg twice daily (BID) was administered orally in fed state, 12 hours apart at approximately the same time each day. AG-013736 dose was titrated or reduced based on the dose modification criteria: the available dose was 2, 3, 5, 7, or 10 mg at a time. One cycle length was 28 days and participants continued the study treatment until intolerable toxicity or disease progression occurred."
464833|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464795|NCT00446992|B1|Baseline|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464796|NCT00446992|P1|Participant Flow|Antipsychotic-Naive Patients|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464797|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464798|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464799|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464800|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464801|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464802|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464803|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464804|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464805|NCT00446992|O1|Outcome|Open Trial Group|"The patients were newly diagnosed with psychosis and were recruited at their first clinical contact for psychosis.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464806|NCT00446992|E1|Reported Event|Open Follow Up Group|"The patients were newly diagnosed with psychosis and this is their first exposure to an antipsychotic.~Olanzapine: 16-week open trial of olanzapine. The patients were started on a dose of 15 mg/d by mouth, which could be adjusted to as low as 10 mg/d or as high as 40 mg/d, based on clinical response. The trial began while they were hospitalized and continued after discharge."
464807|NCT00446849|B1|Baseline|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase. A total of 208 subjects entered the maintenance phase (152 whose UC was quiescent at screening + 56 whose UC was quiescent after the acute phase).
464808|NCT00446849|P1|Participant Flow|Multi-Matrix System (MMX) Mesalamine|Subjects whose ulcerative colitis (UC) was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed orally once-daily [QD] at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed orally QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464809|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464810|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464834|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464811|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464812|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464813|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464814|NCT00446849|O1|Outcome|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day), while those whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464815|NCT00446849|E2|Reported Event|MMX Mesalamine (Maintenance Phase)|Subjects whose ulcerative colitis was quiescent at screening were enrolled directly into the 12-month maintenance phase (MMX Mesalamine dosed QD at 2.4 g/day). Subjects who were treated in the acute phase and attained quiescence were continued into the maintenance phase.
464816|NCT00446849|E1|Reported Event|MMX Mesalamine (Acute Phase)|Subjects whose ulcerative colitis was in flare at screening were enrolled in the 2-month acute phase (MMX Mesalamine dosed QD at 2.4-4.8 g/day).
464817|NCT00446797|B3|Baseline|Total|Total of all reporting groups
464818|NCT00446797|B2|Baseline|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464819|NCT00446797|B1|Baseline|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464820|NCT00446797|P2|Participant Flow|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464821|NCT00446797|P1|Participant Flow|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464822|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464823|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464824|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464825|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464826|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464827|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464828|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464829|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464830|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464831|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464832|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464998|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
464835|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464836|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464837|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464838|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464839|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464840|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464841|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464842|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464843|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464844|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464845|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464846|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464847|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464848|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464849|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464850|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464851|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464852|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464853|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464854|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464855|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464856|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464857|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464858|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464859|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464860|NCT00446797|O2|Outcome|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464861|NCT00446797|O1|Outcome|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464862|NCT00446797|E2|Reported Event|nsNSAIDs|All participants randomized to non-selective non-steroidal anti inflammatory drugs (nsNSAIDs) took the first dose and all subsequent doses according to the standard treatment practice for treatment of pain due to ankle sprain, for up to 7 days.
464863|NCT00446797|E1|Reported Event|Celecoxib|All participants randomized to celecoxib were treated with 2 capsules of celecoxib 200 mg as a loading dose, thereafter, participants took 1 capsule of celecoxib 200 mg twice daily (morning and evening), for up to 7 days. Approximately a 12 hour interval was maintained between doses.
464864|NCT00446654|B3|Baseline|Total|Total of all reporting groups
464865|NCT00446654|B2|Baseline|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
464866|NCT00446654|B1|Baseline|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
464867|NCT00446654|P2|Participant Flow|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
464868|NCT00446654|P1|Participant Flow|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
464869|NCT00446654|O2|Outcome|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
464870|NCT00446654|O1|Outcome|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
464871|NCT00446654|E2|Reported Event|CGC-11047 Once Every Four Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every four weeks.
464872|NCT00446654|E1|Reported Event|CGC-11047 Once Every 2 Weeks|16.5 mg CGC-11047 as a subconjunctival injection once every two weeks.
464873|NCT00446641|B3|Baseline|Total|Total of all reporting groups
464874|NCT00446641|B2|Baseline|Placebo|matching placebo to cilostazol
464875|NCT00446641|B1|Baseline|Cilostazol|Cilostazol 100mg twice per day
464876|NCT00446641|P2|Participant Flow|Placebo|matching placebo to cilostazol
464877|NCT00446641|P1|Participant Flow|Cilostazol|Cilostazol 100mg twice per day
464878|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464879|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464880|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464881|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464882|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464883|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464884|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464885|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464886|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464887|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464888|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464889|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464890|NCT00446641|O2|Outcome|Placebo|matching placebo to cilostazol
464891|NCT00446641|O1|Outcome|Cilostazol|Cilostazol 100mg twice per day
464892|NCT00446641|E2|Reported Event|Placebo|matching placebo to cilostazol
464893|NCT00446641|E1|Reported Event|Cilostazol|Cilostazol 100mg twice per day
464894|NCT00446563|B3|Baseline|Total|Total of all reporting groups
464895|NCT00446563|B2|Baseline|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464896|NCT00446563|B1|Baseline|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464897|NCT00446563|P2|Participant Flow|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464898|NCT00446563|P1|Participant Flow|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464899|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464900|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464999|NCT00446251|E1|Reported Event|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
464901|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464902|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464903|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464904|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464905|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464906|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464907|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464908|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464909|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464910|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464911|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464912|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464913|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464914|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464915|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464916|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464917|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464918|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464919|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464920|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464921|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464922|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464923|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464924|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464925|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464926|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464927|NCT00446563|O2|Outcome|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464928|NCT00446563|O1|Outcome|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464929|NCT00446563|E2|Reported Event|Losartan and HCTZ|Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464930|NCT00446563|E1|Reported Event|Valsartan and Amlodipine|Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
464931|NCT00446511|B5|Baseline|Total|Total of all reporting groups
464932|NCT00446511|B4|Baseline|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464933|NCT00446511|B3|Baseline|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464934|NCT00446511|B2|Baseline|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464935|NCT00446511|B1|Baseline|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464936|NCT00446511|P4|Participant Flow|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464937|NCT00446511|P3|Participant Flow|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464938|NCT00446511|P2|Participant Flow|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464939|NCT00446511|P1|Participant Flow|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464940|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
465000|NCT00446199|B5|Baseline|Total|Total of all reporting groups
464941|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464942|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464943|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464944|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464945|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464946|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464947|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464948|NCT00446511|O2|Outcome|Non-CKD Patients: Enalapril|All non-CKD patients assigned to enalapril in the core study (CVAL489K2302) continued their monotherapy treatment of enalapril 10/20/40 mg stratified by weight.
464949|NCT00446511|O1|Outcome|Non-CKD Patients: Valsartan|All non-CKD patients assigned to valsartan in the core study (CVAL489K2302) continued their monotherapy treatment of valsartan 80/160/320 mg stratified by weight.
464950|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464951|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464952|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464953|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464954|NCT00446511|O4|Outcome|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464955|NCT00446511|O3|Outcome|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464956|NCT00446511|O2|Outcome|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464957|NCT00446511|O1|Outcome|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464958|NCT00446511|E4|Reported Event|Non-CKD Patients: Enalapril|Non-chronic kidney disease (CKD) patients assigned to enalapril in the core study continued their enalapril monotherapy treatment in the extension: Enalapril (10, 20, 40, weight stratified)+valsartan placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464959|NCT00446511|E3|Reported Event|CKD Patients: Enalapril|Chronic kidney disease (CKD) patients assigned to enalapril in the core study received enalapril and valsartan placebo in the extension: Enalapril (10, 20, 40, weight stratified) and matching placebo to valsartan (80, 160, 320 mg). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
465001|NCT00446199|B4|Baseline|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465002|NCT00446199|B3|Baseline|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
464960|NCT00446511|E2|Reported Event|Non-CKD Patients: Valsartan|Non-chronic kidney disease (CKD) patients assigned to valsartan in the core study continued their valsartan monotherapy treatment in the extension: Valsartan (80, 160, 320 mg, weight stratified)+enalapril placebo. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464961|NCT00446511|E1|Reported Event|CKD Patients: Valsartan+Enalapril|Chronic kidney disease (CKD) patients assigned to valsartan in the core study received combination therapy of valsartan and enalapril in the extension: Valsartan+enalapril (80/10, 160/20, 320/40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.
464962|NCT00446459|B1|Baseline|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464963|NCT00446459|P1|Participant Flow|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464964|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464965|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464966|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464967|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464968|NCT00446459|O1|Outcome|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464969|NCT00446459|E1|Reported Event|Mycophenolate Mofetil (MMF) Single Arm Study|MMF mono-therapy, oral dosing of 500 - 1,000 mg twice daily as tolerated.
464970|NCT00446446|B1|Baseline|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464971|NCT00446446|P1|Participant Flow|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464972|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464973|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464974|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464975|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464976|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464977|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464978|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464979|NCT00446446|O1|Outcome|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464980|NCT00446446|E1|Reported Event|Panitumumab|Participants received panitumumab as an intravenous infusion at a dose of 9 mg/kg every 21 days until disease progression, unacceptable toxicity, withdrawal of consent, death, or end of study.
464981|NCT00446290|B1|Baseline|DXP Arm|Docetaxel, capecitabine and oxaliplatin
464982|NCT00446290|P1|Participant Flow|DXO Arm|"Docetaxel, capecitabine and oxaliplatin~Dose level Docetaxel(mg/m2) Capecitabine(mg/m2, twice daily) Oxaliplatin(mg/m2)~45 800 100~60 800 100~60 1,000 100~60 800 130~60 1,000 130"
464983|NCT00446290|O1|Outcome|DXO Arm|Docetaxel, capecitabine and oxaliplatin
464984|NCT00446290|E1|Reported Event|DXO Arm|Docetaxel, capecitabine and oxaliplatin
464985|NCT00446264|B1|Baseline|Single Arm Group|Islet Allotransplantation Group
464986|NCT00446264|P1|Participant Flow|Single Arm Group|Islet Allotransplantation Group
464987|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464988|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464989|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464990|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464991|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464992|NCT00446264|O1|Outcome|Single Arm Group|Islet Allotransplantation Group
464993|NCT00446264|E1|Reported Event|Single Arm Group|Islet Allotransplantation Group
464994|NCT00446251|B1|Baseline|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
464995|NCT00446251|P1|Participant Flow|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
464996|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
464997|NCT00446251|O1|Outcome|Rituximab Infusion and Mycophenolate Mofetil Group|Rituximab was administered by IV infusion at a dose of 1000 mg (1 g) on Days 1 and 15 to subjects already on 8 months of oral mycophenolate mofetil mono therapy (@ 500 - 1,000 mg twice daily as tolerated).
465004|NCT00446199|B1|Baseline|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465005|NCT00446199|P4|Participant Flow|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465006|NCT00446199|P3|Participant Flow|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465007|NCT00446199|P2|Participant Flow|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465008|NCT00446199|P1|Participant Flow|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465009|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465010|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465011|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465012|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465013|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465014|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465015|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465016|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465017|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465018|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465019|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465020|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465021|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465022|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465023|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465024|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465025|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465026|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465027|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465028|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465029|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465030|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465031|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465032|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465033|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465034|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465035|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465036|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465037|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465038|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465039|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465040|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465041|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465042|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465043|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465044|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465045|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465046|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465218|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465047|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465048|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465049|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465050|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465051|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465052|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465053|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465054|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465055|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465056|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465057|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465058|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465059|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465060|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465061|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465062|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465063|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465064|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465065|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465066|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465067|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465068|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465069|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465070|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465071|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465072|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465073|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465074|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465075|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465076|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465077|NCT00446199|O4|Outcome|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465078|NCT00446199|O3|Outcome|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle).
465079|NCT00446199|O2|Outcome|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465080|NCT00446199|O1|Outcome|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465081|NCT00446199|E4|Reported Event|Placebo|Matching placebo tablet per day taken orally for 3 cycles (28 days per cycle).
465082|NCT00446199|E3|Reported Event|Estradiol (E2 0.3mg)|One tablet [17β-estradiol (E2 0.3mg)] per day taken orally for 3 cycles (28 days per cycle)
465083|NCT00446199|E2|Reported Event|0.25mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.25mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465084|NCT00446199|E1|Reported Event|0.5mg DRSP / 0.5mg E2 (BAY86-4891)|One tablet [0.5mg drospirenone/0.5mg 17β-estradiol (DRSP/E2)] per day taken orally for 3 cycles (28 days per cycle).
465085|NCT00446147|B3|Baseline|Total|Total of all reporting groups
465086|NCT00446147|B2|Baseline|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
465087|NCT00446147|B1|Baseline|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
465088|NCT00446147|P2|Participant Flow|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
465089|NCT00446147|P1|Participant Flow|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
465090|NCT00446147|O2|Outcome|Pyridoxine|"100 mg twice per day~Pyridoxine: 100mg BID/daily, Per oral"
465261|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465095|NCT00446147|E1|Reported Event|Placebo|"one tablet twice per day, which is identical to pyridoxine~Placebo: placebo 100mg BID/daily, Per oral"
465096|NCT00446134|B5|Baseline|Total|Total of all reporting groups
465097|NCT00446134|B4|Baseline|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465098|NCT00446134|B3|Baseline|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465099|NCT00446134|B2|Baseline|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465100|NCT00446134|B1|Baseline|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465101|NCT00446134|P4|Participant Flow|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465102|NCT00446134|P3|Participant Flow|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465103|NCT00446134|P2|Participant Flow|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465104|NCT00446134|P1|Participant Flow|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465105|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465106|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465107|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465108|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465109|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465110|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465111|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465112|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465113|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465114|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465115|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465116|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465117|NCT00446134|O4|Outcome|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465118|NCT00446134|O3|Outcome|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465119|NCT00446134|O2|Outcome|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465120|NCT00446134|O1|Outcome|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465121|NCT00446134|E4|Reported Event|Ribavirin 800 mg/Day|Oral ribavirin 800 mg/day (body weight <65 kg), 1000 mg/day (body weight 65-84 kg), 1200 mg/day (body weight 85-104 kg) or 1400 mg/day (body weight greater than or equal to 105 kg) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465122|NCT00446134|E3|Reported Event|Taribavirin 30 mg/kg/Day|Oral taribavirin 30 mg/kg/day actual doses were 30-34 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465123|NCT00446134|E2|Reported Event|Taribavirin 25 mg/kg/Day|Oral taribavirin tablet 25 mg/kg/day actual doses were 25-29 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465124|NCT00446134|E1|Reported Event|Taribavirin 20 mg/kg/Day|Oral taribavirin 20 mg/kg/day (actual doses were 20-24 mg/kg/day) BID plus weekly subcutaneous injections of peginterferon alfa-2b (1.5 ug/kg/wk)
465125|NCT00446095|B6|Baseline|Total|Total of all reporting groups
465126|NCT00446095|B5|Baseline|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
465127|NCT00446095|B4|Baseline|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
465128|NCT00446095|B3|Baseline|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465129|NCT00446095|B2|Baseline|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465130|NCT00446095|B1|Baseline|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465131|NCT00446095|P5|Participant Flow|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
465132|NCT00446095|P4|Participant Flow|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
465133|NCT00446095|P3|Participant Flow|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465134|NCT00446095|P2|Participant Flow|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465135|NCT00446095|P1|Participant Flow|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465136|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465137|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465138|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465139|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465140|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465141|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465142|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
465143|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465144|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465145|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465146|NCT00446095|O4|Outcome|Phase 1: 200mg and 250mg R788 BID|Patients who received 200mg or 250mg R788 orally twice daily (PO BID) in Phase I
465147|NCT00446095|O3|Outcome|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465148|NCT00446095|O2|Outcome|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465149|NCT00446095|O1|Outcome|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465150|NCT00446095|E5|Reported Event|Phase I: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase I
465151|NCT00446095|E4|Reported Event|Phase I: 200mg R788 BID|Patients who received 200mg R788 orally twice daily (PO BID) in Phase I
465152|NCT00446095|E3|Reported Event|Phase II: Other Lymphomas|Patients with mantle cell lymphoma, mucosa-associated lymphoid tissue (MALT) lymphoma, marginal zone lymphomas, small lymphocytic lymphomas and chronic lymphocytic leukemia (SLL/CLL) in Phase II
465153|NCT00446095|E2|Reported Event|Phase II: 250mg R788 BID|Patients who received 250mg R788 orally twice daily (PO BID) in Phase II
465154|NCT00446095|E1|Reported Event|Phase II: DLBCL|Patients with diffuse large B-cell lymphoma (DLBCL) in Phase II
465155|NCT00446030|B3|Baseline|Total|Total of all reporting groups
465156|NCT00446030|B2|Baseline|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
465157|NCT00446030|B1|Baseline|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
465158|NCT00446030|P2|Participant Flow|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
465159|NCT00446030|P1|Participant Flow|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
465160|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
465161|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
465162|NCT00446030|O2|Outcome|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
465163|NCT00446030|O1|Outcome|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
465217|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465164|NCT00446030|E2|Reported Event|Stratum 2: TCH + Bevacizumab|HER2 positive participants were administered chemotherapy with docetaxel, carboplatin and trastuzumab (TCH) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab and trastuzumab every 3 weeks for a total of 52 weeks.
465165|NCT00446030|E1|Reported Event|Stratum 1: TAC + Bevacizumab|HER2 negative participants were administered chemotherapy with docetaxel, doxorubicin and cyclosphosphamide (TAC) + bevacizumab every 3 weeks for 6 cycles, and maintenance therapy with bevacizumab every 3 weeks for a total of 52 weeks.
465166|NCT00445939|B4|Baseline|Total|Total of all reporting groups
465167|NCT00445939|B3|Baseline|Placebo|Placebo at Week 0, placebo Week 2
465168|NCT00445939|B2|Baseline|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465169|NCT00445939|B1|Baseline|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465170|NCT00445939|P4|Participant Flow|Adalimumab 40mg /40 mg|Non-responders continued after 4 weeks, Adalimumab 160 at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6; Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6.
465171|NCT00445939|P3|Participant Flow|Placebo|Placebo at Week 0, placebo at Week 2
465172|NCT00445939|P2|Participant Flow|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465173|NCT00445939|P1|Participant Flow|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465174|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
465175|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
465176|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
465177|NCT00445939|O3|Outcome|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, placebo at Week 2, adalimumab 160 mg at Week 4, and adalimumab 80 mg at Week 6
465178|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
465179|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6
465180|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2,
465181|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465182|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465183|NCT00445939|O3|Outcome|Placebo + 160/80 mg|Placebo at Week 0, placebo at Week 2
465184|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465185|NCT00445939|O1|Outcome|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465186|NCT00445939|O3|Outcome|Placebo|Placebo at Week 0, placebo at Week 2
465187|NCT00445939|O2|Outcome|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465188|NCT00445939|O1|Outcome|Adalimumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465189|NCT00445939|E6|Reported Event|Placebo + Adalimumab 160/80 mg|Placebo at Week 0, Placebo at Week 2, 160 mg at Week 4, 80 mg at Week 6
465190|NCT00445939|E5|Reported Event|80/40 mg + 40/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
465191|NCT00445939|E4|Reported Event|Adalimumab 160 mg/80 mg + 40/40 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2, 40 mg at Week 4, 40 mg at Week 6
465192|NCT00445939|E3|Reported Event|Placebo|Placebo at Week 0, placebo at Week 2
465193|NCT00445939|E2|Reported Event|Adalimumab 80 mg/40 mg|Adalimumab 80 mg at Week 0, 40 mg at Week 2
465194|NCT00445939|E1|Reported Event|Adaliumab 160 mg/80 mg|Adalimumab 160 mg at Week 0, 80 mg at Week 2
465195|NCT00443898|B5|Baseline|Total|Total of all reporting groups
465196|NCT00443898|B4|Baseline|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465197|NCT00443898|B3|Baseline|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465198|NCT00443898|B2|Baseline|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465199|NCT00443898|B1|Baseline|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465200|NCT00443898|P4|Participant Flow|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465201|NCT00443898|P3|Participant Flow|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465202|NCT00443898|P2|Participant Flow|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465203|NCT00443898|P1|Participant Flow|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465204|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465205|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465206|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465207|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465208|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465209|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465210|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465211|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465212|NCT00443898|O4|Outcome|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465213|NCT00443898|O3|Outcome|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465214|NCT00443898|O2|Outcome|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465215|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465219|NCT00443898|O1|Outcome|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465220|NCT00443898|E4|Reported Event|Vehicle 48 w|vehicle (placebo) applied once daily for 48 weeks
465221|NCT00443898|E3|Reported Event|Terbinafine 48 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
465222|NCT00443898|E2|Reported Event|Vehicle 24 w|vehicle (placebo) applied once daily for 24 weeks
465223|NCT00443898|E1|Reported Event|Terbinafine 24 w|Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
465224|NCT00443872|B1|Baseline|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
465225|NCT00443872|P1|Participant Flow|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
465226|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (MMSE)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
465227|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BAI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
465228|NCT00443872|O1|Outcome|All PD Patients With DA Related AEs (BDI)|All patients had a DA related AE and received 1.25 mg once daily orally disintegrating selegiline which was increased after 6 weeks to 2.5mg once daily if tolerated.
465229|NCT00443872|O1|Outcome|All Subjects PDQ-39|This includes all patients in the study. They all received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks which was increased to 2.5 mg once daily if tolerated.
465230|NCT00443872|O1|Outcome|All Subjects With DA Related AEs (UPDRS Data)|For all completed subjects (60) UPDRS activities of daily living scores and motor scores were collected. All patients received 1.25 mg once daily orally disintegrating selegiline for 6 weeks which was increased to 2.5mg once daily at 12 weeks if tolerated.
465231|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Impulse Control Disorder)|Patients who are experiencing dopamine agonist (DA) related adverse effect (AE) of impulse control disorder (ICD) received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5mg once daily if tolerated.
465232|NCT00443872|O1|Outcome|PD Patiens With DA Related AE (Pedal Edema)|Patients who are experiencing a dopamine agonist (DA) related AE of pedal edema received 1.25mg once daily of orally disintegrating selegiline for 6 weeks after which there was an increase to 2.5 mg once daily if tolerated.
465233|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Hallucinations)|Patients who are experiencing the dopamine agonist (DA) related adverse effect of hallucinations. The participants received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks after which it was increased to 2.5 mg once daily if tolerated.
465234|NCT00443872|O1|Outcome|PD Patients With DA Related AE (Daytime Sleepiness)|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of daytime sleepiness received 1.25 mg once daily of orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for the remaining 6 weeks if tolerated.
465235|NCT00443872|O1|Outcome|PD Patients With DA Related AE|Patients who are experiencing a dopamine agonist (DA) related adverse effect (AE) of either one or more of the following: excessive daytime sleepiness, hallucinations, pedal edema, impulse control disorder, received 1.25 mg once daily orally disintegrating selegiline for 6 weeks with an increase to 2.5 mg once daily orally disintegrating selegiline for remaining 6 weeks if tolerated.
465236|NCT00443872|E1|Reported Event|PD Patients With DA Related AE|This is a one arm open label study of PD patients with a DA related AE
465237|NCT00443820|B5|Baseline|Total|Total of all reporting groups
465238|NCT00443820|B4|Baseline|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465239|NCT00443820|B3|Baseline|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465240|NCT00443820|B2|Baseline|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465241|NCT00443820|B1|Baseline|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465242|NCT00443820|P4|Participant Flow|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465243|NCT00443820|P3|Participant Flow|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465244|NCT00443820|P2|Participant Flow|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465245|NCT00443820|P1|Participant Flow|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465246|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465247|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465248|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465249|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465250|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465251|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465252|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465253|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465254|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465255|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465256|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465257|NCT00443820|O1|Outcome|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465258|NCT00443820|O4|Outcome|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465259|NCT00443820|O3|Outcome|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465260|NCT00443820|O2|Outcome|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465262|NCT00443820|E4|Reported Event|Vehicle 48 Weeks|Vehicle (placebo) for 48 weeks
465263|NCT00443820|E3|Reported Event|Terbinafine 48 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
465264|NCT00443820|E2|Reported Event|Vehicle 24 Weeks|Vehicle (placebo) for 24 weeks
465265|NCT00443820|E1|Reported Event|Terbinafine 24 Weeks|Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
465266|NCT00443781|B1|Baseline|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
465267|NCT00443781|P1|Participant Flow|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
465268|NCT00443781|O1|Outcome|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
465269|NCT00443781|E1|Reported Event|PD and F.A.D. Diagnostic Testing|Subjects with chronic axial low back pain with suspected degenerative disc disease underwent provocative discography(PD)followed by Functional Anaesthetic Discography (F.A.D.)as part of a pilot, multicenter, prospective, single-arm diagnostic study.
465270|NCT00443755|B3|Baseline|Total|Total of all reporting groups
465271|NCT00443755|B2|Baseline|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465272|NCT00443755|B1|Baseline|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465273|NCT00443755|P2|Participant Flow|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465274|NCT00443755|P1|Participant Flow|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465275|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465276|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465277|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465278|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465279|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465280|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465281|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465282|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465283|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465284|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465285|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465286|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465287|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465288|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465289|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465290|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465291|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465292|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465293|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465294|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465295|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465296|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465297|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465298|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465299|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465300|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465301|NCT00443755|O2|Outcome|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465302|NCT00443755|O1|Outcome|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465303|NCT00443755|E2|Reported Event|Placebo|Placebo tablets were used to match the active comparator drugs and dosing regimen. The number of subjects analyzed for baseline measures and outcome measures were the 13 subjects who completed the study.
465304|NCT00443755|E1|Reported Event|Insulin Sensitizer Therapy|Two insulin sensitizing drugs will be taken together for 3 months; metformin 1000 mg twice daily plus pioglitazone 45 mg daily. The number of subjects analyzed for baseline measures and outcome measures were the 12 subjects who completed the study.
465305|NCT00445848|B1|Baseline|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465306|NCT00445848|P1|Participant Flow|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465307|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465308|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465309|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465310|NCT00445848|O1|Outcome|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465311|NCT00445848|E1|Reported Event|Erlotinib and Bevacizumab|Patients received erlotinib 150 mg daily with bevacizumab at 15mg/kg until progression or prohibitive toxicity.
465312|NCT00445770|B4|Baseline|Total|Total of all reporting groups
465313|NCT00445770|B3|Baseline|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465314|NCT00445770|B2|Baseline|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465315|NCT00445770|B1|Baseline|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465316|NCT00445770|P3|Participant Flow|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465317|NCT00445770|P2|Participant Flow|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465318|NCT00445770|P1|Participant Flow|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465319|NCT00445770|O2|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465320|NCT00445770|O1|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465321|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465322|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465323|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465324|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465325|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465326|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465327|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465328|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465329|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465330|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465331|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465332|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465333|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465334|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465335|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465336|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465337|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465338|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465339|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465340|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465341|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465342|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465343|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465344|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465345|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465346|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465347|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465348|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465349|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465350|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465351|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465352|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465353|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465354|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465355|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465356|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465357|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465358|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465359|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465360|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465361|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465362|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465363|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465364|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465365|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465366|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465424|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465367|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465368|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465369|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465370|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465371|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465372|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465373|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465374|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465375|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465376|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465377|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465378|NCT00445770|O3|Outcome|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465379|NCT00445770|O2|Outcome|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465380|NCT00445770|O1|Outcome|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465381|NCT00445770|E3|Reported Event|Etanercept 25 mg|Participants received 25 mg twice weekly SC and oral placebo capsules once weekly for 52 weeks
465382|NCT00445770|E2|Reported Event|Etanercept 10 mg|Participants received 10 mg SC twice weekly and oral placebo capsules once weekly for 52 weeks
465383|NCT00445770|E1|Reported Event|Methotrexate|Participants received 4 milligrams (mg) up to 8 mg orally (2.0 mg capsules), once weekly for 52 weeks and subcutaneous (SC) placebo injections twice weekly
465384|NCT00445705|B5|Baseline|Total|Total of all reporting groups
465385|NCT00445705|B4|Baseline|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465386|NCT00445705|B3|Baseline|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465387|NCT00445705|B2|Baseline|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465388|NCT00445705|B1|Baseline|Placebo|Part A: Placebo every 12 hours for 4 weeks
465389|NCT00445705|P4|Participant Flow|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465390|NCT00445705|P3|Participant Flow|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465391|NCT00445705|P2|Participant Flow|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465392|NCT00445705|P1|Participant Flow|Placebo|Part A: Placebo every 12 hours for 4 weeks
465393|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465394|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465395|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465396|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
465397|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465398|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465399|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465400|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
465401|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465402|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465403|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465404|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
465405|NCT00445705|O4|Outcome|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465406|NCT00445705|O3|Outcome|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465407|NCT00445705|O2|Outcome|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465408|NCT00445705|O1|Outcome|Placebo|Part A: Placebo every 12 hours for 4 weeks
465409|NCT00445705|E4|Reported Event|AGN 203818 60 mg|Part A: 60 mg AGN 203818 every 12 hours for 4 weeks
465410|NCT00445705|E3|Reported Event|AGN 203818 20 mg|Part A: 20 mg AGN 203818 every 12 hours for 4 weeks
465411|NCT00445705|E2|Reported Event|AGN 203818 3 mg|Part A: 3 mg AGN 203818 every 12 hours for 4 weeks
465412|NCT00445705|E1|Reported Event|Placebo|Part A: Placebo every 12 hours for 4 weeks
465413|NCT00445679|B5|Baseline|Total|Total of all reporting groups
465414|NCT00445679|B4|Baseline|Paroxetine 20|Paroxetine 20 mg/day
465415|NCT00445679|B3|Baseline|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465416|NCT00445679|B2|Baseline|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465417|NCT00445679|B1|Baseline|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465418|NCT00445679|P4|Participant Flow|Paroxetine 20|Paroxetine 20 mg/day
465419|NCT00445679|P3|Participant Flow|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465420|NCT00445679|P2|Participant Flow|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465421|NCT00445679|P1|Participant Flow|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465422|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465423|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465425|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465426|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465427|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465428|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465429|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465430|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465431|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465432|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465433|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465434|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465435|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465436|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465437|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465438|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465439|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465440|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465441|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465442|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465443|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465444|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465445|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465446|NCT00445679|O4|Outcome|Paroxetine 20|Paroxetine 20 mg/day
465447|NCT00445679|O3|Outcome|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465448|NCT00445679|O2|Outcome|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465449|NCT00445679|O1|Outcome|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465450|NCT00445679|E4|Reported Event|Paroxetine 20|Paroxetine 20 mg/day
465451|NCT00445679|E3|Reported Event|DVS SR 200|Desvenlafaxine Succinate Sustained-Release (DVS SR) 200 mg/day
465452|NCT00445679|E2|Reported Event|DVS SR 100|Desvenlafaxine Succinate Sustained-Release (DVS SR) 100 mg/day
465453|NCT00445679|E1|Reported Event|DVS SR 50|Desvenlafaxine Succinate Sustained-Release (DVS SR) 50 mg/day
465454|NCT00445588|B1|Baseline|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
465455|NCT00445588|P1|Participant Flow|Treatment|"Patients receive oral erlotinib hydrochloride 150 mg once daily and oral sorafenib tosylate 400 mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
465456|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
465457|NCT00445588|O1|Outcome|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride 150mg: Given orally once daily~sorafenib tosylate 400mg: Given orally twice daily~pharmacological study: Correlative studies"
465458|NCT00445588|E1|Reported Event|Treatment|"Patients receive oral erlotinib hydrochloride 150mg once daily and oral sorafenib tosylate 400mg twice daily on days 1-28. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study~erlotinib hydrochloride: 150mg Given orally once daily~sorafenib tosylate: 400mg Given orally twice daily~pharmacological study: Correlative studies"
465459|NCT00445549|B1|Baseline|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
465460|NCT00445549|P1|Participant Flow|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
465461|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
465462|NCT00445549|O1|Outcome|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
465463|NCT00445549|E1|Reported Event|Vandetanib Treatment|300 mg daily oral dose, 28 day cycle
465464|NCT00445484|B3|Baseline|Total|Total of all reporting groups
465465|NCT00445484|B2|Baseline|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465466|NCT00445484|B1|Baseline|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465467|NCT00445484|P2|Participant Flow|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465497|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465468|NCT00445484|P1|Participant Flow|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465469|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465470|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465471|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465472|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465473|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465474|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465475|NCT00445484|O2|Outcome|Vaccine Started 45 Days After Lenalidomide|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465476|NCT00445484|O1|Outcome|Vaccine Started 14 Days Prior to Lenalidomide|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465477|NCT00445484|E2|Reported Event|Group 2|"Patients receive lenalidomide as in group 1. Patients receive pneumococcal polyvalent vaccine IM approximately 45 days after beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465478|NCT00445484|E1|Reported Event|Group 1|"Patients receive oral lenalidomide on days 1-21. Treatment repeats every 28 days for up to 7 courses in the absence of disease progression or unacceptable toxicity. Patients receive pneumococcal polyvalent vaccine intramuscularly (IM) 14 days prior to beginning lenalidomide and again in approximately 2 months (after the first dose of the vaccine).~pneumococcal polyvalent vaccine: Given intramuscularly~lenalidomide: Given orally"
465479|NCT00445432|B4|Baseline|Total|Total of all reporting groups
465480|NCT00445432|B3|Baseline|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465481|NCT00445432|B2|Baseline|Placebo Eow|Double-blind adalimumab placebo every other week
465482|NCT00445432|B1|Baseline|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465483|NCT00445432|P4|Participant Flow|Any Adalimumab|All participants in NCT00445432 (Study M06-837) who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465484|NCT00445432|P3|Participant Flow|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465485|NCT00445432|P2|Participant Flow|Placebo Eow|Double-blind adalimumab placebo every other week
465486|NCT00445432|P1|Participant Flow|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465487|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465488|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465489|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465490|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465491|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465492|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465493|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465494|NCT00445432|O1|Outcome|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465495|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465496|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465498|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465499|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465500|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465501|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465502|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465503|NCT00445432|O1|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465504|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465505|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465506|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465507|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465508|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465509|NCT00445432|O3|Outcome|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465510|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465511|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465512|NCT00445432|O2|Outcome|Placebo Eow|Double-blind adalimumab placebo every other week
465513|NCT00445432|O1|Outcome|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465514|NCT00445432|E4|Reported Event|Any Adalimumab|All participants in this study who received at least 1 dose of adalimumab 40 mg every other week (double-blind or open-label).
465515|NCT00445432|E3|Reported Event|OL Adalimumab 40 mg Eow|Open-label adalimumab 40 mg every other week
465516|NCT00445432|E2|Reported Event|Placebo Eow|Double-blind adalimumab placebo every other week
465517|NCT00445432|E1|Reported Event|DB Adalimumab 40 mg Eow|Double-blind adalimumab 40 mg every other week
465518|NCT00445341|B1|Baseline|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
465519|NCT00445341|P1|Participant Flow|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
465520|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
465521|NCT00445341|O1|Outcome|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
465522|NCT00445341|E1|Reported Event|Flavopiridol in Lymphoma Patients|Flavopiridol 30 mg/m^2 is given weekly for 4 weeks followed by a 2 week break for up to 6 cycles. It is given through a vein as a 30 minute infusion followed by a 4 hour infusion.
465523|NCT00445328|B3|Baseline|Total|Total of all reporting groups
465524|NCT00445328|B2|Baseline|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465525|NCT00445328|B1|Baseline|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465526|NCT00445328|P2|Participant Flow|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465527|NCT00445328|P1|Participant Flow|Dalteparin|5000 IU (International Units) dalteparin in 0.2 mL (milliliters) subcutaneously once a day (Arm A)
465528|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465529|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465530|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465531|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465532|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465533|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465534|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465535|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465536|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465537|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465538|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465539|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465540|NCT00445328|O2|Outcome|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465541|NCT00445328|O1|Outcome|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465542|NCT00445328|E2|Reported Event|Unfractionated Heparin|5000 IU unfractionated Heparin (UFH) in 5 mL subcutaneously 3 times a day (Arm B) for 6 to 14 days.
465543|NCT00445328|E1|Reported Event|Dalteparin|5000 IU dalteparin in 0.2 mL subcutaneously once a day (Arm A)
465544|NCT00445315|B6|Baseline|Total|Total of all reporting groups
465545|NCT00445315|B5|Baseline|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465546|NCT00445315|B4|Baseline|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465547|NCT00445315|B3|Baseline|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465728|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465548|NCT00445315|B2|Baseline|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465549|NCT00445315|B1|Baseline|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465550|NCT00445315|P5|Participant Flow|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465551|NCT00445315|P4|Participant Flow|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465552|NCT00445315|P3|Participant Flow|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465553|NCT00445315|P2|Participant Flow|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465554|NCT00445315|P1|Participant Flow|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465555|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465556|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465557|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465558|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465559|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465560|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465561|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465562|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465563|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465564|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465565|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465566|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465567|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465568|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465569|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465570|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465571|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465572|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465573|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465574|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465575|NCT00445315|O5|Outcome|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465576|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465577|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465578|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465579|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465580|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465581|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465582|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465583|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465584|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465585|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465586|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465587|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465588|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465589|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465590|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465591|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465592|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465593|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465594|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465595|NCT00445315|O3|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465596|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465597|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465598|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465599|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465600|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465601|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465602|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465603|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465604|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465605|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465606|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465607|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465608|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465609|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465610|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465611|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465612|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465613|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465614|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465615|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465616|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465617|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465618|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465619|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465620|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465621|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465622|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465623|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465624|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465625|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465626|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465627|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465628|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465629|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465630|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465631|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465632|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465633|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465634|NCT00445315|O4|Outcome|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465635|NCT00445315|O3|Outcome|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465636|NCT00445315|O2|Outcome|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465637|NCT00445315|O1|Outcome|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465638|NCT00445315|E5|Reported Event|Placebo|Placebo matched to PF-00868554 powder for oral solution, twice daily or three times daily on Day 1 through Day 7 and once in morning on Day 8.
465639|NCT00445315|E4|Reported Event|PF-00868554 450 mg Twice Daily|PF-00868554 450 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465640|NCT00445315|E3|Reported Event|PF-00868554 300 mg Three Times Daily|PF-00868554 300 mg powder for oral solution, three times daily on Day 1 through Day 7 and once in morning on Day 8.
465641|NCT00445315|E2|Reported Event|PF-00868554 300 mg Twice Daily|PF-00868554 300 mg powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465642|NCT00445315|E1|Reported Event|PF-00868554 100 mg Twice Daily|PF-00868554 100 milligram (mg) powder for oral solution, twice daily on Day 1 through Day 7 and once in morning on Day 8.
465643|NCT00445302|B5|Baseline|Total|Total of all reporting groups
465644|NCT00445302|B4|Baseline|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465645|NCT00445302|B3|Baseline|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465646|NCT00445302|B2|Baseline|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465647|NCT00445302|B1|Baseline|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465648|NCT00445302|P4|Participant Flow|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465649|NCT00445302|P3|Participant Flow|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465650|NCT00445302|P2|Participant Flow|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465651|NCT00445302|P1|Participant Flow|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465652|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465653|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465654|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465655|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465656|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465657|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465658|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465659|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465660|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465661|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465662|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465663|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465664|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465665|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465666|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465667|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465668|NCT00445302|O4|Outcome|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465669|NCT00445302|O3|Outcome|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465670|NCT00445302|O2|Outcome|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465671|NCT00445302|O1|Outcome|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465672|NCT00445302|E4|Reported Event|Severe Renal Impairment|Participants with severe renal impairment (CLcr < 31 mL/min, not requiring dialysis). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465673|NCT00445302|E3|Reported Event|Moderate Renal Impairment|Participants with moderate renal impairment (CLcr = 31 to 50 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465674|NCT00445302|E2|Reported Event|Mild Renal Impairment|Participants with mild renal impairment (CLcr = 51 to 80 mL/min). Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465675|NCT00445302|E1|Reported Event|Normal Renal Function|Participants with normal renal function (creatinine clearance (CLcr) > 90 ml/min) used as a control. Participants treated with one dose of plerixafor (240 µg/kg) administered by subcutaneous (SC) injection.
465676|NCT00445263|B3|Baseline|Total|Total of all reporting groups
465677|NCT00445263|B2|Baseline|Delayed Invasive Strategy|Coronarography after six hours
465678|NCT00445263|B1|Baseline|Early Invasive Strategy|Tirofiban and coronarography within six hours
465679|NCT00445263|P2|Participant Flow|Delayed Invasive Strategy|Coronarography after six hours
465680|NCT00445263|P1|Participant Flow|Early Invasive Strategy|Tirofiban and coronarography within six hours
465681|NCT00445263|O2|Outcome|Delayed Invasive Strategy|Coronarography after six hours
465682|NCT00445263|O1|Outcome|Early Invasive Strategy|Tirofiban and coronarography within six hours
465683|NCT00445263|E2|Reported Event|Delayed Invasive Strategy|Coronarography after six hours
465684|NCT00445263|E1|Reported Event|Early Invasive Strategy|Tirofiban and coronarography within six hours
465685|NCT00445224|B3|Baseline|Total|Total of all reporting groups
465686|NCT00445224|B2|Baseline|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465687|NCT00445224|B1|Baseline|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465688|NCT00445224|P2|Participant Flow|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465689|NCT00445224|P1|Participant Flow|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465690|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465691|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465692|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465693|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465694|NCT00445224|O2|Outcome|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465695|NCT00445224|O1|Outcome|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465696|NCT00445224|E2|Reported Event|Quadricep Group Then Combined Exercises|Performed quadricep strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465729|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465697|NCT00445224|E1|Reported Event|Hip Strengthening Then Combined Exercises|Performed hip strengthening exercises for 4 weeks prior to crossing over to a combined hip and quadricep rehabilitation program
465698|NCT00445146|B1|Baseline|EVG+RTV|EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study. Some participants may have received EVG 300 mg during the course of protocol amendment 2.
465699|NCT00445146|P1|Participant Flow|EVG+RTV|"Elvitegravir (EVG) 85 or 150 mg tablet boosted with ritonavir (RTV; r/) 100 mg capsule once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465700|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465701|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465702|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465703|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465704|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465705|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465706|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465707|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465708|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465709|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465710|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465711|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465712|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465713|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465714|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465715|NCT00445146|O1|Outcome|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule once daily with food in combination with an investigator-selected ARV regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465716|NCT00445146|E1|Reported Event|EVG+RTV|"EVG 85 or 150 mg tablet boosted with RTV 100 mg capsule administered orally once daily with food in combination with an investigator-selected antiretroviral (ARV) regimen for the duration of the study.~Some participants may have received EVG 300 mg during the course of protocol amendment 2."
465717|NCT00445003|B4|Baseline|Total|Total of all reporting groups
465718|NCT00445003|B3|Baseline|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465719|NCT00445003|B2|Baseline|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465720|NCT00445003|B1|Baseline|Sham Injection|Sham injection at baseline and 4 weeks
465721|NCT00445003|P3|Participant Flow|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465722|NCT00445003|P2|Participant Flow|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465723|NCT00445003|P1|Participant Flow|Sham Injection|Sham injection at baseline and 4 weeks
465724|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465725|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465726|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465727|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465730|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465731|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465732|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465733|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465734|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465735|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465736|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465737|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465738|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465739|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465740|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465741|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465742|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465743|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465744|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465745|NCT00445003|O3|Outcome|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465746|NCT00445003|O2|Outcome|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465747|NCT00445003|O1|Outcome|Sham Injection|Sham injection at baseline and 4 weeks
465748|NCT00445003|E3|Reported Event|4-mg Triamcinolone Acetonided|4-mg Triamcinolone Acetonide at baseline and sham injection at 4 weeks
465749|NCT00445003|E2|Reported Event|0.5mg Ranibizumab|Intravitreal injections of 0.5mg Ranibizumab at baseline and at 4 weeks
465750|NCT00445003|E1|Reported Event|Sham Injection|Sham injection at baseline and 4 weeks
465751|NCT00444951|B4|Baseline|Total|Total of all reporting groups
465752|NCT00444951|B3|Baseline|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465753|NCT00444951|B2|Baseline|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465754|NCT00444951|B1|Baseline|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
465755|NCT00444951|P3|Participant Flow|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465756|NCT00444951|P2|Participant Flow|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465757|NCT00444951|P1|Participant Flow|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
465758|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465759|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465760|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
465761|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465762|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465763|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
465764|NCT00444951|O3|Outcome|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465765|NCT00444951|O2|Outcome|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465766|NCT00444951|O1|Outcome|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
466918|NCT00442338|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
465767|NCT00444951|E3|Reported Event|Control Group|Participants who had not previously been given any meningococcal vaccine received 1 dose of Menactra®, meningococcal (serogroups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine.
465768|NCT00444951|E2|Reported Event|Mencevax® Group|Participants who had previously been given 1 dose of quadrivalent (A, C, Y, W-135) and at least 1 dose of bivalent (A, C) meningococcal polysaccharide vaccine received a booster dose of Mencevax ACWY (serogroups A, C, Y, W-135) polysaccharide meningococcal vaccine.
465769|NCT00444951|E1|Reported Event|Menactra® Group|Participants have received previously a dose of an A, C, Y, W-135 vaccine and at least one dose of bivalent A, C meningococcal polysaccharide vaccine, received a booster dose of Menactra® (Meningococcal [serogroups A, C, Y, W-135] polysaccharide diphtheria toxoid conjugate) vaccine.
465770|NCT00444925|B4|Baseline|Total|Total of all reporting groups
465771|NCT00444925|B3|Baseline|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465772|NCT00444925|B2|Baseline|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465773|NCT00444925|B1|Baseline|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465774|NCT00444925|P3|Participant Flow|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465775|NCT00444925|P2|Participant Flow|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465776|NCT00444925|P1|Participant Flow|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465777|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465778|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465779|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465780|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465781|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465782|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465783|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465784|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465785|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465786|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465787|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465788|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465789|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465790|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465791|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465792|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465793|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465794|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465795|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465796|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465797|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465798|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465799|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465800|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465801|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465802|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465803|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465804|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465805|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465806|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465807|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465808|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465855|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465809|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465810|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465811|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465812|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465813|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465814|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465815|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465816|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465817|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465818|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465819|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465820|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465821|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465822|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465823|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465824|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465825|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465826|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465827|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465828|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465829|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465830|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465831|NCT00444925|O3|Outcome|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465832|NCT00444925|O2|Outcome|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465833|NCT00444925|O1|Outcome|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465834|NCT00444925|E3|Reported Event|Fesoterodine|Tablets (4 mg PO QD for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks)
465835|NCT00444925|E2|Reported Event|Tolterodine ER|Capsules (4 mg) PO QD for 12 weeks. Tolterodine Extended Release (ER)
465836|NCT00444925|E1|Reported Event|Placebo|Tablets (4 milligrams [mg] orally (PO) once daily (QD) for 1 week followed by a forced dose escalation to 8 mg PO QD for 11 weeks) or capsules (4 mg) PO QD for 12 weeks
465837|NCT00444912|B3|Baseline|Total|Total of all reporting groups
465838|NCT00444912|B2|Baseline|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465839|NCT00444912|B1|Baseline|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465840|NCT00444912|P2|Participant Flow|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465841|NCT00444912|P1|Participant Flow|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465842|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465843|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465844|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465845|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465846|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465847|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465848|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465849|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465850|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465851|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465852|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465853|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465854|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465856|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465857|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465858|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465859|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465860|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465861|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465862|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465863|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465864|NCT00444912|O2|Outcome|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465865|NCT00444912|O1|Outcome|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465866|NCT00444912|E2|Reported Event|G-CSF and Plerixafor + Rituximab|Participants with CD20+ lymphoma received rituximab, G-CSF, and plerixafor
465867|NCT00444912|E1|Reported Event|G-CSF and Plerixafor|Participants with CD20- lymphoma received granulocyte colony-stimulating factor (G-CSF) and plerixafor
465868|NCT00444795|B1|Baseline|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
465869|NCT00444795|P1|Participant Flow|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
465870|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
465871|NCT00444795|O1|Outcome|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
465872|NCT00444795|E1|Reported Event|Sutene|Participants were administered with Sutene as part of routine clinical practice. The use and dosage recommendations for Sutene were based on the approved local product document and were adjusted solely according to medical and therapeutic necessity.
465873|NCT00444626|B1|Baseline|Combined Arms|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
465874|NCT00444626|P1|Participant Flow|Combined Arm|Participants received DGE in one nasolabial fold (NLF) on one side of their face and Restylane in one NLF on the other side of their face (blinded, split-face study design) in the Initial Treatment. For participants who continued into the Repeat Treatment Period, they received DGE in both NLFs as an open-label treatment.
465875|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
465876|NCT00444626|O2|Outcome|Restylane - Dermal Gel Extra (DGE)|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. In the Repeat Treatment Period, participants received DGE on both sides of their face. This represents the experience with DGE for the side of the face that was originally treated with Restylane.
465877|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
465878|NCT00444626|O3|Outcome|Non-NLF|Adverse events that did not occur at the nasolabial folds
465879|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465880|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period, they received DGE in all NLFs as an open-label treatment.
465881|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465882|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465883|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465884|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465885|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465886|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465887|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465888|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465889|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465890|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465891|NCT00444626|O2|Outcome|Restylane|Participants received Restylane in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period.
465892|NCT00444626|O1|Outcome|Dermal Gel Extra (DGE)|Participants received DGE in one nasolabial fold (NLF) of one side of their face (blinded, split-face study design) in the Initial Treatment period. Participants who continued into the Repeat Treatment Period received DGE in all NLFs as an open-label treatment.
465893|NCT00444626|E6|Reported Event|Non-NLF: Repeat Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Repeat Treatment Period regardless to relationship to DGE treatment.
465894|NCT00444626|E5|Reported Event|Restylane - Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with Restylane in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
465895|NCT00444626|E4|Reported Event|Dermal Gel Extra (DGE) - Repeat Treatment Period|Adverse events that occurred at the nasolabial fold that was treated with DGE in the Initial Treatment Period, and occurred during the Repeat Treatment Period regardless of relationship to DGE treatment.
465896|NCT00444626|E3|Reported Event|Non-NLF: Initial Treatment Period|Adverse events that did not occur at the nasolabial folds, and occurred during the Initial Treatment Period regardless to relationship to either DGE or Restylane treatment.
465897|NCT00444626|E2|Reported Event|Restylane: Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with Restylane, and occurred during the Initial Treatment Period regardless of relationship to Restylane treatment.
465898|NCT00444626|E1|Reported Event|Dermal Gel Extra (DGE): Initial Treatment Period|Adverse events that occurred at the nasolabial fold treated with DGE, and occurred during the Initial Treatment Period regardless of relationship to DGE treatment.
465899|NCT00444600|B5|Baseline|Total|Total of all reporting groups
465900|NCT00444600|B4|Baseline|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465901|NCT00444600|B3|Baseline|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465902|NCT00444600|B2|Baseline|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465903|NCT00444600|B1|Baseline|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465904|NCT00444600|P4|Participant Flow|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465905|NCT00444600|P3|Participant Flow|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465906|NCT00444600|P2|Participant Flow|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465907|NCT00444600|P1|Participant Flow|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465908|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465909|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465910|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465911|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465912|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
466110|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466111|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
465913|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465914|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465915|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465916|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465917|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465918|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465919|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465920|NCT00444600|O3|Outcome|Triamcinolone|
465921|NCT00444600|O2|Outcome|Ranibizumab|
465922|NCT00444600|O1|Outcome|Sham|
465923|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465924|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465925|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465926|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465927|NCT00444600|O3|Outcome|Triamcinolone|
465928|NCT00444600|O2|Outcome|Ranibizumab|
465929|NCT00444600|O1|Outcome|Sham|
465930|NCT00444600|O3|Outcome|Triamcinolone|
465931|NCT00444600|O2|Outcome|Ranibizumab|
465932|NCT00444600|O1|Outcome|Sham|
465933|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465934|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465935|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465936|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465937|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465938|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465939|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465940|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465941|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465942|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
466112|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466113|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
465943|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465944|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465945|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465946|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465947|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465948|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465949|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465950|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465951|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465952|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465953|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465954|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465955|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465956|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465957|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465958|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465959|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465960|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465961|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465962|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465963|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465964|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465965|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
466114|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466919|NCT00442338|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg IV Administration
465966|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465967|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465968|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465969|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465970|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465971|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465972|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465973|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465974|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465975|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465976|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465977|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465978|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465979|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465980|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465981|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465982|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465983|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465984|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465985|NCT00444600|O4|Outcome|4 mg Triamcinolone+Prompt Laser|4 mg intravitreal triamcinolone at randomization plus focal photocoagulation 1 week post-injection, repeated every 16 weeks with sham injections at 4-week intervals in-between. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465986|NCT00444600|O3|Outcome|0.5 mg Ranibizumab+Deferred Laser|0.5 mg intravitreal ranibizumab at randomization, repeated every 4 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT. If improvement has not occured from injections alone, laser can be given starting at the 24 week visit.
465987|NCT00444600|O2|Outcome|0.5 mg Ranibizumab+Prompt Laser|0.5 mg intravitreal ranibizumab at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
465988|NCT00444600|O1|Outcome|Sham+Prompt Laser|Sham injection at randomization plus focal photocoagulation 1 week post-injection. Injections are repeated every 4 weeks with focal photocoagulation given post-injection every 16 weeks. Retreatment starting at 16 weeks depends on visual acuity and OCT.
466115|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
465989|NCT00444600|E7|Reported Event|Sham + Triamcinolone + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
465990|NCT00444600|E6|Reported Event|Sham + Ranibizumab + Deferred Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
465991|NCT00444600|E5|Reported Event|Sham + Ranibizumab + Laser|Participants in this group had 2 study eyes, the right eye was assigned randomly with equal probability to one of the four groups (Sham + prompt laser, ranibizumab + prompt laser, ranibizumab + deferred laser, triamcinolone + prompt laser). If the right eye was assigned to a treatment group other than the sham + prompt laser group, then the left eye was assigned to the sham + prompt laser group. If the right eye was assigned to the sham prompt + prompt laser group, then the left eye was assigned randomly to one of the other three groups.
465992|NCT00444600|E4|Reported Event|Triamcinolone + Prompt Laser|4 mg intravitreal triamcinolone plus prompt (within 3–10 days after injection) focal/grid photocoagulation
465993|NCT00444600|E3|Reported Event|Ranibizumab + Deferred Laser|0.5 mg intravitreal ranibizumab with deferred (24 weeks) focal/grid photocoagulation
465994|NCT00444600|E2|Reported Event|Ranibizumab + Prompt Laser|0.5 mg intravitreal ranibizumab plus prompt (within 3–10 days after injection) focal/grid photocoagulation
465995|NCT00444600|E1|Reported Event|Sham + Prompt Laser|Laser was given within 3 to 10 days after sham injections, Laser = Focal/grid photocoagulation
465996|NCT00444587|B3|Baseline|Total|Total of all reporting groups
465997|NCT00444587|B2|Baseline|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
465998|NCT00444587|B1|Baseline|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
465999|NCT00444587|P2|Participant Flow|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
466000|NCT00444587|P1|Participant Flow|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab (Herceptin) 6 milligrams per kilograms (mg/kg) of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous (IV) infusion every three weeks until disease progression, unacceptable toxicities, or withdrawal from study, in combination with second line chemotherapy.
466001|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants received second line chemotherapy according to the investigator's decision.
466002|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466003|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466004|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466005|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466006|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466007|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466008|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466009|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466010|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466011|NCT00444587|O2|Outcome|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
466012|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466116|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466117|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466013|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466014|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466015|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466016|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), intravenous infusion, every three weeks until progression or withdrawal, in combination with second line chemotherapy.
466017|NCT00444587|O1|Outcome|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
466018|NCT00444587|E2|Reported Event|Only Chemotherapy|Eligible participants were administered second line chemotherapy according to the investigator’s decision.
466019|NCT00444587|E1|Reported Event|Trastuzumab + 2nd Line Chemotherapy|Eligible participants were administered trastuzumab 6 mg/kg of body weight (except in Israel, where the dose was 2 mg/kg body weight), IV infusion, every three weeks until disease progression, unacceptable toxicities, or withdrawal from study in combination with second line chemotherapy.
466020|NCT00444535|B1|Baseline|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466021|NCT00444535|P1|Participant Flow|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466022|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466023|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466024|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466025|NCT00444535|O1|Outcome|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466026|NCT00444535|E1|Reported Event|Lapatinib + Bevacizumab|Lapatinib (1500 mg once daily taken orally) and bevacizumab (10 mg/kg intravenously [IV] every two weeks)
466027|NCT00444457|B5|Baseline|Total|Total of all reporting groups
466028|NCT00444457|B4|Baseline|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466029|NCT00444457|B3|Baseline|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466030|NCT00444457|B2|Baseline|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466031|NCT00444457|B1|Baseline|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466043|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466118|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466119|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466032|NCT00444457|P4|Participant Flow|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466033|NCT00444457|P3|Participant Flow|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466034|NCT00444457|P2|Participant Flow|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466035|NCT00444457|P1|Participant Flow|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466036|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466037|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466038|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466039|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466040|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466041|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466042|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466044|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466045|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466046|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466047|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466048|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466049|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466050|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466051|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466052|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466053|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466054|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466055|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466056|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466101|NCT00444275|P4|Participant Flow|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466102|NCT00444275|P3|Participant Flow|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466057|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466058|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466059|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466060|NCT00444457|O4|Outcome|7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466061|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466062|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466063|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (Infant series Dose 1, 2, and 3, respectively); coadministered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).
466064|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466065|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466066|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466067|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466103|NCT00444275|P2|Participant Flow|Esomeprazole 40 mg Once Daily (Initial Phase)|
466104|NCT00444275|P1|Participant Flow|Esomeprazole 20 mg Once Daily (Initial Phase)|
466105|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466106|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466107|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466068|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466069|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466070|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466071|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466072|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466073|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466074|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466075|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466076|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466108|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466077|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466078|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466079|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466080|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466081|NCT00444457|O2|Outcome|7vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466082|NCT00444457|O1|Outcome|Combined 13vPnC|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 or 2, or manufacturing lot at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466083|NCT00444457|O3|Outcome|13vPnC (Manufacturing Lot)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466084|NCT00444457|O2|Outcome|13vPnC (Pilot Lot 2)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466085|NCT00444457|O1|Outcome|13vPnC (Pilot Lot 1)|Participants received 1 single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series) and 12 months of age (toddler dose); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age; a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.
466109|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466920|NCT00442338|O3|Outcome|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
466086|NCT00444457|E10|Reported Event|Post Toddler Dose 6-Month Follow-up 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
466087|NCT00444457|E9|Reported Event|Post Toddler Dose 6-Month Follow-up Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose) ; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age (assessment at 18 months of age; 6 months after the toddler dose).
466088|NCT00444457|E8|Reported Event|Toddler Dose 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=75; systematic (solicited) Local Reactions N=83; systematic (solicited) Systemic Events N=128."
466089|NCT00444457|E7|Reported Event|Toddler Dose Combined 13vPnC|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 12 months of age; co-administered with a commercially available Measles, Mumps, and Rubella-varicella vaccine (MMR-varicella), or if not available, a commercially available MMR and a commercially available varicella vaccine administered in separate injections; and a commercially available hepatitis A vaccine (HAV) administered at 12 months of age.~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=434; systematic (solicited) Local Reactions N=473; systematic (solicited) Systemic Events N=771."
466090|NCT00444457|E6|Reported Event|After the Infant Series 7vPnC|Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
466091|NCT00444457|E5|Reported Event|After the Infant Series Combined 13vPnC|Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1, 2, or manufacturing lot at 2, 4, and 6 months of age (assessment at 7 months of age; 1 month after the infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age(assessment at 7 months of age; 1 month after the infant series).
466092|NCT00444457|E4|Reported Event|Infant Series 7vPnC|"Participants received 1 single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=207; systematic (solicited) Local Reactions N=142; systematic (solicited) Systemic Events N=198."
466093|NCT00444457|E3|Reported Event|Infant Series 13vPnC (Manufacturing Lot)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) manufacturing lot (manu lot) at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=402; systematic (solicited) Local Reactions N=250; systematic (solicited) Systemic Events N=386."
466094|NCT00444457|E2|Reported Event|Infant Series 13vPnC (Pilot Lot 2)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 2 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=394; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=364."
466095|NCT00444457|E1|Reported Event|Infant Series 13vPnC (Pilot Lot 1)|"Participants received 1 single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) pilot lot 1 at 2, 4, and 6 months of age (infant series); co-administered with Pediarix® (a commercially available combination diphtheria and tetanus toxoid; acellular pertussis and hepatitis B antigens; and inactivated poliovirus); and a commercially available Haemophilus influenzae type b (Hib) vaccine at 2, 4, and 6 months of age (infant series).~Other Adverse Events (non-serious events): the number affected (N) for non-systematic (unsolicited) Other Adverse Events N=407; systematic (solicited) Local Reactions N=262; systematic (solicited) Systemic Events N=373."
466096|NCT00444275|B4|Baseline|Total|Total of all reporting groups
466097|NCT00444275|B3|Baseline|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466098|NCT00444275|B2|Baseline|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466099|NCT00444275|B1|Baseline|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466100|NCT00444275|P5|Participant Flow|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466120|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466121|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466122|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466123|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466124|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466125|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466126|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466127|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466128|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466129|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466130|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466131|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466132|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466133|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466134|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466135|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466136|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466137|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466138|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466139|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466140|NCT00444275|O5|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466141|NCT00444275|O4|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466142|NCT00444275|O3|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466143|NCT00444275|O2|Outcome|Esomeprazole 40 mg Once Daily (Initial Phase)|
466144|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Initial Phase)|
466145|NCT00444275|O3|Outcome|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466146|NCT00444275|O2|Outcome|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466147|NCT00444275|O1|Outcome|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466148|NCT00444275|E5|Reported Event|Antacid Treatment (Maintenance Phase)|antacid treatment as needed (maintenance phase) (Xolaam® maximum six tablets per day)
466149|NCT00444275|E4|Reported Event|Esomeprazole 20 mg on Demand (Maintenance Phase)|
466150|NCT00444275|E3|Reported Event|Esomeprazole 20 mg Once Daily (Maintenance Phase)|
466151|NCT00444275|E2|Reported Event|Esomeprazole 40 mg Once Daily (Initial Phase)|
466152|NCT00444275|E1|Reported Event|Esomeprazole 20 mg Once Daily (Initial Phase)|
466153|NCT00444106|B4|Baseline|Total|Total of all reporting groups
466154|NCT00444106|B3|Baseline|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
466155|NCT00444106|B2|Baseline|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
466156|NCT00444106|B1|Baseline|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466157|NCT00444106|P3|Participant Flow|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
466158|NCT00444106|P2|Participant Flow|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
466159|NCT00444106|P1|Participant Flow|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466160|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
466161|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
466162|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466163|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin) 250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
466164|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) tablets containing 250 mg atovaquone and 100 mg proguanil hydrochloride once daily for 3 days dosage dependent on body weight.
466165|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466166|NCT00444106|O3|Outcome|Artesunate-mefloquine|Artesunate (Plasmotrim) 50 mg tablet; based on body weight for a dosage of 4 mg/kg/day for 3 days- mefloquine (Mephaquin)250 mg tablets; based on body weight for a total dosage of 25 mg/kg once daily on days 2 and 3.
466167|NCT00444106|O2|Outcome|Atovaquone-proguanil (Malarone)|Atovaquone-proguanil (Malarone) 250mg tablets once daily for 3 days dosage dependent on body weight.
466168|NCT00444106|O1|Outcome|Artemether-lumefantrine|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466169|NCT00444106|O1|Outcome|Artemether-lumefantrine (Coartem)|Artemether-lumefantrine (Coartem) tablets containing 20 mg artemether and 120 mg lumefantrine twice a day for 3 days dosage dependent on body weight.
466170|NCT00444106|E3|Reported Event|Artesunate-Mefloquine|Artesunate-Mefloquine
466171|NCT00444106|E2|Reported Event|Atovaquone-proguanil|Atovaquone-proguanil
466172|NCT00444106|E1|Reported Event|Artemether-lumefantrine|Artemether-lumefantrine
466173|NCT00444067|B3|Baseline|Total|Total of all reporting groups
466174|NCT00444067|B2|Baseline|Control|Standard of care methods used as an adjunct to sutured dural repair.
466175|NCT00444067|B1|Baseline|Spinal Sealant|DuraSeal Spinal Sealant System
466176|NCT00444067|P2|Participant Flow|Control|Standard of care methods used as an adjunct to sutured dural repair.
466177|NCT00444067|P1|Participant Flow|Spinal Sealant|DuraSeal Spinal Sealant System
466178|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
466179|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
466180|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
466181|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
466182|NCT00444067|O2|Outcome|Control|Standard of care methods used as an adjunct to sutured dural repair.
466183|NCT00444067|O1|Outcome|Spinal Sealant|DuraSeal Spinal Sealant System
466184|NCT00444067|E2|Reported Event|Control|Standard of care methods used as an adjunct to sutured dural repair.
466185|NCT00444067|E1|Reported Event|Spinal Sealant|DuraSeal Spinal Sealant System
466186|NCT00443729|B3|Baseline|Total|Total of all reporting groups
466187|NCT00443729|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466188|NCT00443729|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466189|NCT00443729|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466190|NCT00443729|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466191|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466192|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466193|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466194|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466195|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466196|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466197|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466198|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466199|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466200|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466201|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466446|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466202|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466203|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466204|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466205|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466206|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466207|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466208|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466209|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466210|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466211|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466212|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466213|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466214|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466215|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466216|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466217|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466218|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466219|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466220|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466221|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466222|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466447|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466223|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466224|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466225|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466226|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466227|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466228|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466229|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466230|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466231|NCT00443729|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466232|NCT00443729|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466233|NCT00443729|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466234|NCT00443729|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466235|NCT00443703|B3|Baseline|Total|Total of all reporting groups
466236|NCT00443703|B2|Baseline|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466237|NCT00443703|B1|Baseline|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466238|NCT00443703|P2|Participant Flow|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466239|NCT00443703|P1|Participant Flow|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466240|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466241|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466242|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466243|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466244|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466245|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466246|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466247|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466248|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466249|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466250|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466251|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466252|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466253|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466254|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466255|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466256|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466257|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466258|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466259|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466260|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466261|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466262|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466263|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466264|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466265|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466448|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve attached
466266|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466267|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466268|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466269|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466270|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466271|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466272|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466273|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466274|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466275|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466276|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466277|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466278|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466279|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466280|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466281|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466282|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466283|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466284|NCT00443703|O2|Outcome|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466285|NCT00443703|O1|Outcome|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466286|NCT00443703|E2|Reported Event|KALETRA™ 400/100 mg b.i.d.|KALETRA™ 400/100 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to MK0518 , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466449|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve attached
466287|NCT00443703|E1|Reported Event|MK0518 400 mg b.i.d.|MK0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food, and placebo to KALETRA™ , which can be taken by mouth (PO) twice a day (b.i.d.), approximately 12 hours (10 to 14 hours) apart without regard to food
466288|NCT00443651|B3|Baseline|Total|Total of all reporting groups
466289|NCT00443651|B2|Baseline|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466290|NCT00443651|B1|Baseline|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466291|NCT00443651|P2|Participant Flow|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466292|NCT00443651|P1|Participant Flow|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466293|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466294|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466295|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466296|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466297|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466298|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466299|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466300|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466450|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466301|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466302|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466303|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466304|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466305|NCT00443651|O2|Outcome|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466306|NCT00443651|O1|Outcome|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466307|NCT00443651|E2|Reported Event|Rituximab 500 mg (Stage II Patients)|Stage II patients received 2 doses of rituximab 500 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 500 mg given 14 days apart. Concomitant biological and non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466308|NCT00443651|E1|Reported Event|Rituximab 1000 mg (Stage I Patients)|Stage I patients received 2 doses of rituximab 1000 mg administered intravenously (IV) 14 days apart at the beginning of the study (Days 1 and 15). During Weeks 24 to 40, patients who met disease activity and safety criteria were eligible to receive 2 additional IV infusions of rituximab 1000 mg given 14 days apart. Concomitant non-biological disease-modifying anti-rheumatic drug (DMARD) therapy, at a stable dose and route, was continued during the study, except for protocol defined prohibited DMARDs/combinations.
466309|NCT00443599|B3|Baseline|Total|Total of all reporting groups
466310|NCT00443599|B2|Baseline|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
466311|NCT00443599|B1|Baseline|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
466312|NCT00443599|P2|Participant Flow|Standard Care|Usual Care : Participants receive standard Cardiac ICU care without tight blood glucose control.
466313|NCT00443599|P1|Participant Flow|Tight Glycemic Control|Insulin : Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
466314|NCT00443599|O2|Outcome|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
466315|NCT00443599|O1|Outcome|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
466316|NCT00443599|E2|Reported Event|Usual Care|Usual Care: Participants receive standard Cardiac ICU care without tight blood glucose control.
466317|NCT00443599|E1|Reported Event|Insulin|Insulin: Study drug is continuously infused intravenous insulin. Suggested dose is calculated by a computerized infusion algorithm using the participant's blood sugar concentration. The insulin infusion rate is titrated to maintain normal blood sugar. Participants are eligible to receive insulin while they have an in-dwelling arterial catheter.
466318|NCT00443560|B3|Baseline|Total|Total of all reporting groups
466319|NCT00443560|B2|Baseline|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466320|NCT00443560|B1|Baseline|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466321|NCT00443560|P2|Participant Flow|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466322|NCT00443560|P1|Participant Flow|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466323|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466324|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466325|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466326|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466327|NCT00443560|O2|Outcome|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466328|NCT00443560|O1|Outcome|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466329|NCT00443560|E2|Reported Event|Spontaneous Vaginal Delivery (SVD)|The control group consisted of parturients who had a spontaneous vaginal delivery (SVD)in the same 24 hour period who were case-matched for gravidity and parity.
466330|NCT00443560|E1|Reported Event|Instrumental Vaginal Delivery (IVD)|Instrumental vaginal delivery (IVD) is attempted to prevent fetal hypoxia if the second stage of labor is prolonged. It includes forceps and vacuum extractions.
466331|NCT00443534|B1|Baseline|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466332|NCT00443534|P1|Participant Flow|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466333|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466334|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466335|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466336|NCT00443534|O1|Outcome|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466337|NCT00443534|E1|Reported Event|Sunitinib|Participants received sunitinib (SU011248) capsules in one of the standard sunitinib schedules: Schedule 4/2 [4 weeks on study drug, 2 weeks off treatment]; Schedule 2/1 [2 weeks on study drug, 1 week off treatment]; Schedule 2/2 [2 weeks on study drug, 2 weeks off treatment]; or continuous dosing). The starting dose for all dosing regimens except continuous dosing was 50 milligram (mg) orally once daily (37.5 mg orally once daily for continuous dosing).
466338|NCT00443456|B1|Baseline|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
466339|NCT00443456|P1|Participant Flow|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study.
466340|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466341|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466342|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466343|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466344|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466451|NCT00443118|E3|Reported Event|SIB Without PEEP|Subjects allocated to be ventilated with Self Inflating Bag without PEEP valve
466345|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466346|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466347|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466348|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466349|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466350|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466351|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466352|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466353|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466354|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466355|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466356|NCT00443456|O2|Outcome|Subjects Without Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who did not use concomitant antihypertensive agent during this long-term study (A0531086: NCT00443456).
466357|NCT00443456|O1|Outcome|Subjects With Concomitant Antihypertensive Agent|Subjects receiving 10 mg amlodipine who were treated with concomitant antihypertensive agent at Week 12 or later.
466358|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466359|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466360|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466361|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466362|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466363|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466364|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466365|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466366|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466367|NCT00443456|O3|Outcome|The Preceding Study 10 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 10 mg in the preceding study (A0531085: NCT00415623) then continued to receive 10 mg in this long-term study (A0531086: NCT00443456).
466368|NCT00443456|O2|Outcome|The Preceding Study 5 mg Sub-set of This Long-term Study|Sub-set of subjects who received amlodipine 5 mg in the preceding study (A0531085: NCT00415623) then received 10 mg in this long-term study (A0531086: NCT00443456).
466369|NCT00443456|O1|Outcome|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study (A0531086: NCT00443456).
466370|NCT00443456|E1|Reported Event|Amlodipine|All subjects who were treated with amlodipine at a dose of 10 mg during this long-term study
466371|NCT00443430|B3|Baseline|Total|Total of all reporting groups
466372|NCT00443430|B2|Baseline|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466373|NCT00443430|B1|Baseline|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466374|NCT00443430|P2|Participant Flow|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466375|NCT00443430|P1|Participant Flow|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466376|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466377|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466378|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466379|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466380|NCT00443430|O2|Outcome|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466381|NCT00443430|O1|Outcome|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466382|NCT00443430|E2|Reported Event|Methotrexate-Prednisolone-Etanercept Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus etanercept 0.8 mg/kg given by subcutaneous injection once per week, plus prednisolone by mouth daily with decreasing dose tapered over 16 weeks
466383|NCT00443430|E1|Reported Event|Methotrexate Arm|Methotrexate 0.5 mg/kg given by subcutaneous injection once per week, plus placebo etanercept and placebo prednisolone
466384|NCT00443352|B1|Baseline|Duloxetine Completers|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
466385|NCT00443352|P1|Participant Flow|Duloxetine|Duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
466386|NCT00443352|O1|Outcome|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
466387|NCT00443352|E1|Reported Event|Duloxetine|duloxetine: Duloxetine: 120 mg. daily or maximum tolerated dose (minimum: 60 mg per day)
466388|NCT00443209|B3|Baseline|Total|Total of all reporting groups
466389|NCT00443209|B2|Baseline|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466390|NCT00443209|B1|Baseline|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466391|NCT00443209|P2|Participant Flow|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466392|NCT00443209|P1|Participant Flow|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466393|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466394|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466395|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466396|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466397|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466398|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466399|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466452|NCT00443118|E2|Reported Event|SIB - Self Inflating Bag With PEEP|Subjects allocated to be ventilated with Self Inflating Bag with PEEP valve
466453|NCT00443118|E1|Reported Event|T-Piece|Subjects assigned to be resuscitated with T-Piece
466400|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466401|NCT00443209|O2|Outcome|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466402|NCT00443209|O1|Outcome|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466403|NCT00443209|E2|Reported Event|Rizatriptan 10 mg|Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
466404|NCT00443209|E1|Reported Event|Telcagepant 280 mg/300 mg|Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months.
466405|NCT00443118|B4|Baseline|Total|Total of all reporting groups
466406|NCT00443118|B3|Baseline|Self Inflating Bag Without PEEP|Subjects allocated to Self Inflating Bag without PEEP
466407|NCT00443118|B2|Baseline|Self Inflating Bag With PEEP|Subjects allocated to Self Inflating Bag with PEEP
466408|NCT00443118|B1|Baseline|T-Piece|Subjects assigned to be resuscitated with T-Piece
466409|NCT00443118|P3|Participant Flow|SIB-Without PEEP Valve|Self inflating bag without PEEP valve
466410|NCT00443118|P2|Participant Flow|SIB - With PEEP Valve|Subjects allocated to SIB with a PEEP valve attached
466411|NCT00443118|P1|Participant Flow|T-Piece|Subjects assigned to be resuscitated with T-Piece
466412|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to be resuscitated with Self Inflating Bag Without PEEP valve
466413|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466414|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466415|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
466416|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Without PEEP valve
466417|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466418|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocate to SIB Without PEEP valve
466419|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
466420|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466421|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
466422|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466423|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466424|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|subjects allocated to SIB-Without PEEP valve
466425|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466426|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466427|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to SIB-Without PEEP valve
466428|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466429|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466430|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Self Inflating Bag without PEEP valve
466431|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466432|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466433|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag Without PEEP valve
466434|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with PEEP valve
466435|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466436|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects Allocated to SIB without PEEP valve
466437|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to SIB with PEEP valve
466438|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466439|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag without PEEP valve
466440|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to Self Inflating Bag with a PEEP valve attached
466441|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466442|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Sujects allocated to be ventilated with Self Inflating Bag Without PEEP valve
466443|NCT00443118|O2|Outcome|SIB - Self Inflating Bag With PEEP Valve|Subjects allocated to be ventilated using a Self Inlfating Bag with PEEP valve
466444|NCT00443118|O1|Outcome|T-Piece|Subjects assigned to be resuscitated with T-Piece
466445|NCT00443118|O3|Outcome|SIB-Without PEEP Valve|Subjects allocated to Self Inflating Bag withouth a PEEP valve
466454|NCT00443053|B3|Baseline|Total|Total of all reporting groups
466456|NCT00443053|B1|Baseline|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466457|NCT00443053|P2|Participant Flow|Placebo|Matching placebo
466458|NCT00443053|P1|Participant Flow|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466459|NCT00443053|O2|Outcome|Placebo|Matching placebo
466460|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466461|NCT00443053|O2|Outcome|Placebo|Matching placebo
466462|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466463|NCT00443053|O2|Outcome|Placebo|Matching placebo
466464|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466465|NCT00443053|O2|Outcome|Placebo|Matching placebo
466466|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466467|NCT00443053|O2|Outcome|Placebo|Matching placebo
466468|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466469|NCT00443053|O2|Outcome|Placebo|Matching placebo
466470|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466471|NCT00443053|O2|Outcome|Placebo|Matching placebo
466472|NCT00443053|O1|Outcome|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466473|NCT00443053|E2|Reported Event|Placebo|Matching placebo
466474|NCT00443053|E1|Reported Event|Fondaparinux 2.5 mg|Fondaparinux 2.5 milligrams (mg) administered subcutaneously (SC) once daily for 45 days
466475|NCT00443040|B4|Baseline|Total|Total of all reporting groups
466476|NCT00443040|B3|Baseline|Placebo|Matching Placebo
466477|NCT00443040|B2|Baseline|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
466478|NCT00443040|B1|Baseline|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
466479|NCT00443040|P3|Participant Flow|Placebo|Matching Placebo
466480|NCT00443040|P2|Participant Flow|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
466481|NCT00443040|P1|Participant Flow|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
466482|NCT00443040|O3|Outcome|Placebo|Matching Placebo
466483|NCT00443040|O2|Outcome|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
466484|NCT00443040|O1|Outcome|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
466485|NCT00443040|E3|Reported Event|Placebo|Matching Placebo
466486|NCT00443040|E2|Reported Event|Asimadoline 3.0 mg|Asimadoline 3.0 mg b.i.d.
466487|NCT00443040|E1|Reported Event|Asimadoline 1.0 mg|Asimadoline 1.0 mg b.i.d.
466488|NCT00442962|B1|Baseline|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466489|NCT00442962|P1|Participant Flow|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466490|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466491|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466492|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466493|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466494|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466495|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466496|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466497|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466498|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466499|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466500|NCT00442962|O1|Outcome|EFV + FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466501|NCT00442962|E1|Reported Event|EFV+FTC/TDF|Participants will take a daily regimen of efavirenz and emtricitabine/tenofovir disoproxil fumarate for 48 weeks
466502|NCT00442936|B5|Baseline|Total|Total of all reporting groups
466503|NCT00442936|B4|Baseline|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466504|NCT00442936|B3|Baseline|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466505|NCT00442936|B2|Baseline|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466709|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466506|NCT00442936|B1|Baseline|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466507|NCT00442936|P4|Participant Flow|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466508|NCT00442936|P3|Participant Flow|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466509|NCT00442936|P2|Participant Flow|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466510|NCT00442936|P1|Participant Flow|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466511|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466512|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466513|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466514|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466515|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466516|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466517|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466518|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466519|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466520|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466521|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466522|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466710|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466523|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466524|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466525|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466526|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466527|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466528|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466529|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466530|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466531|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466532|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466533|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466534|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466535|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466536|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466537|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466538|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466539|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466656|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466540|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466541|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466542|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466543|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466544|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466545|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466546|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466547|NCT00442936|O4|Outcome|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466548|NCT00442936|O3|Outcome|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466549|NCT00442936|O2|Outcome|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466550|NCT00442936|O1|Outcome|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466551|NCT00442936|E4|Reported Event|Placebo|Participants receive placebo matching capsules or tablets, one capsule or tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466552|NCT00442936|E3|Reported Event|Zolmitriptan 5 mg|Participants receive zolmitriptan 5 mg tablets, one tablet administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (placebo) or one dose of non-study rescue medication.
466553|NCT00442936|E2|Reported Event|Telcagepant 300 mg|Participants receive telcagepant 300 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 300 mg or placebo) or one dose of non-study rescue medication.
466554|NCT00442936|E1|Reported Event|Telcagepant 150 mg|Participants receive telcagepant 150 mg capsules, one capsule administered orally at initial onset of moderate to severe migraine headache. If, after 2 hours post-dose, participants still have a moderate to severe migraine or migraine recurs, participants may receive an optional second dose of study drug (telcagepant 150 mg or placebo) or one dose of non-study rescue medication.
466555|NCT00442897|B3|Baseline|Total|Total of all reporting groups
466556|NCT00442897|B2|Baseline|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
466557|NCT00442897|B1|Baseline|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
466558|NCT00442897|P2|Participant Flow|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
466657|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466559|NCT00442897|P1|Participant Flow|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
466560|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
466561|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
466562|NCT00442897|O2|Outcome|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
466563|NCT00442897|O1|Outcome|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
466564|NCT00442897|E2|Reported Event|Atorvastatin|Atorvastatin group- Patients who were allocated to atorvastatin had atorvastatin 10 mg or 20 mg tablet, orally, once a day.
466565|NCT00442897|E1|Reported Event|Vytorin|Vytorin group- The eligible patients were allocated to one of vytorin 10/20 or atorvastatin 10 mg group in 1:1 ratio. If patients didn't achieve LDL-C < 100 mg/dl after 6 weeks of treatment, they received the double dosage of study drug for the next 6 weeks (vytorin 10/40 or atorvastatin 20 mg) and If patients achieved LDL-C < 100 mg/dl, they received the same dosage of study drug for the next 6 weeks. Patients who were allocated to vytorin had vytorin 10/20 mg or 10/40 mg tablet, orally, once a day.
466566|NCT00442702|B3|Baseline|Total|Total of all reporting groups
466567|NCT00442702|B2|Baseline|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466568|NCT00442702|B1|Baseline|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466569|NCT00442702|P2|Participant Flow|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466570|NCT00442702|P1|Participant Flow|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466571|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466572|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466573|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466574|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466575|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466576|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466577|NCT00442702|O2|Outcome|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466909|NCT00442351|O2|Outcome|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
466578|NCT00442702|O1|Outcome|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466579|NCT00442702|E2|Reported Event|Darbepoetin Alfa|Participants continued to receive the same dose of darbepoetin alfa by subcutaneous injection once every week, once every 2 weeks or once every month as per local labeling during the dose titration (7 months) and the evaluation period (2 months).
466580|NCT00442702|E1|Reported Event|Mircera|Participants received Mircera by subcutaneous injection once every month during the dose titration (7 months) and evaluation period (2 months). The starting dose was based on the weekly dose of darbepoetin alfa administered prior to the switch to Mircera, and was either 120, 200 or 360 µg Mircera per month. The dose was then adjusted to maintain Hemoglobin levels within the defined target range and also according to the need for red blood cell transfusions (due to worsening anemia), or for toxicity related to Mircera.
466581|NCT00442689|B4|Baseline|Total|Total of all reporting groups
466582|NCT00442689|B3|Baseline|Placebo - 3|Placebo
466583|NCT00442689|B2|Baseline|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466584|NCT00442689|B1|Baseline|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466585|NCT00442689|P3|Participant Flow|Placebo - 3|Placebo only
466586|NCT00442689|P2|Participant Flow|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466587|NCT00442689|P1|Participant Flow|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
466588|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466589|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466590|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466591|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466592|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466593|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466594|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466595|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466596|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466597|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466598|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466599|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466600|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466601|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466602|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466603|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466604|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466605|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466606|NCT00442689|O3|Outcome|Placebo - 3|Placebo
466607|NCT00442689|O2|Outcome|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466608|NCT00442689|O1|Outcome|Oral Contraceptive - 1|Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)
466609|NCT00442689|E3|Reported Event|Placebo - 3|Placebo only
466610|NCT00442689|E2|Reported Event|Flutamide - 2|"Flutamide~Flutamide: 250 mg twice daily"
466611|NCT00442689|E1|Reported Event|Oral Contraceptive - 1|"Oral contraceptive (containing 35mcg of ethinyl estradiol and 3mg of drospirenone)~Oral contraceptive: one active pill per day for three weeks and then 1 sugar pill per day for one week"
466612|NCT00442611|B3|Baseline|Total|Total of all reporting groups
466613|NCT00442611|B2|Baseline|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466614|NCT00442611|B1|Baseline|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466615|NCT00442611|P2|Participant Flow|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466616|NCT00442611|P1|Participant Flow|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466617|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466618|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466619|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466921|NCT00442338|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg IV Administration
466620|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466621|NCT00442611|O2|Outcome|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466622|NCT00442611|O1|Outcome|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466623|NCT00442611|E2|Reported Event|IV Fluid|"The placebo arm will receive matched intravenous fluids.~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466624|NCT00442611|E1|Reported Event|Abatacept|"Study drug, Abatacept, will be administered in a double-blind fashion to the active arm of the study. It will be administered intravenously.~Abatacept: Active drug, abatacept, will be administered intravenously in a blinded fashion~Abatacept: Abatacept will be administered, dosed based upon weight, intravenously on days 1, 15, 30 and monthly thereafter for a total of 7 doses."
466625|NCT00442598|B4|Baseline|Total|Total of all reporting groups
466626|NCT00442598|B3|Baseline|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466627|NCT00442598|B2|Baseline|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466628|NCT00442598|B1|Baseline|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466629|NCT00442598|P3|Participant Flow|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466630|NCT00442598|P2|Participant Flow|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466631|NCT00442598|P1|Participant Flow|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466632|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466633|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466634|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466635|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466636|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466637|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466638|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466639|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466640|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466641|NCT00442598|O3|Outcome|Glufosfamide q7 Days High|"1-hour infusion of glufosfamide at a dose of 2,500 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466642|NCT00442598|O2|Outcome|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466643|NCT00442598|O1|Outcome|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466644|NCT00442598|E2|Reported Event|Glufosfamide q7 Days Low|"1-hour infusion of glufosfamide at a dose of 1,660 mg/m2 on Days 1, 8 and 15 of a 21-day cycle~Glufosfamide"
466645|NCT00442598|E1|Reported Event|Glufosfamide q21 Days|"1-hour infusion of glufosfamide at a dose of 5,000 mg/m2 on Day 1 of a 21-day cycle~Glufosfamide"
466646|NCT00442572|B3|Baseline|Total|Total of all reporting groups
466647|NCT00442572|B2|Baseline|No Intervention|Participants were on non- specific anti-viral treatment.
466648|NCT00442572|B1|Baseline|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466649|NCT00442572|P2|Participant Flow|No Intervention|Participants were on non- specific anti-viral treatment.
466650|NCT00442572|P1|Participant Flow|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a (PEGASYS®). Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms (µg) in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously (SC) and followed by 12 weeks period without treatment.
466651|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466652|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466653|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466654|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466655|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466658|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466659|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466660|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466661|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466662|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466663|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466664|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466665|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466666|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466667|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466668|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466669|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466670|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466671|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466672|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466673|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466674|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466675|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466676|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466677|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466678|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466679|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466680|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466681|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466682|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment.
466683|NCT00442572|O2|Outcome|No Intervention|Participants were on non- specific anti-viral treatment.
466684|NCT00442572|O1|Outcome|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 µg in 0.5 ml solution in prefilled syringes, applied once weekly SC and followed by 12 weeks period without treatment..
466685|NCT00442572|E2|Reported Event|No Intervention|Participants were on non- specific anti-viral treatment.
466686|NCT00442572|E1|Reported Event|PEGASYS|Participants received 4 treatment cycles of continuous intermittent treatment with Peginterferon alfa-2a. Each cycle consisted of 12 weeks injection treatment with Peginterferon alfa-2a 135 micrograms in 0.5 ml solution in prefilled syringes, applied once weekly subcutaneously and followed by 12 weeks period without treatment.
466687|NCT00442559|B3|Baseline|Total|Total of all reporting groups
466688|NCT00442559|B2|Baseline|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466689|NCT00442559|B1|Baseline|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466690|NCT00442559|P2|Participant Flow|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466691|NCT00442559|P1|Participant Flow|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466692|NCT00442559|O4|Outcome|Daily Allergic Rhinitis Symptom Score 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466693|NCT00442559|O3|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466694|NCT00442559|O2|Outcome|Daily Allergic Rhinitis Symptom Score at 12 Weeks- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466695|NCT00442559|O1|Outcome|Daily Allergic Rhinitis Symptom Score at Baseline- Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466696|NCT00442559|O4|Outcome|Daytime Asthma Symptom Score at 12 Weeks - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466697|NCT00442559|O3|Outcome|Daytime Asthma Symptom Score at Baseline - ICS|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466698|NCT00442559|O2|Outcome|Daytime Asthma Symptom Score at 12 Weeks - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466699|NCT00442559|O1|Outcome|Daytime Asthma Symptom Score at Baseline - Montelukast|Participants received study drug and had efficacy measurements both at baseline and during the treatment period. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466700|NCT00442559|E2|Reported Event|Inhaled Corticosteroids (ICS)|Participants were treated for 12 months after randomization: Each participant's physician selected the ICS agent, dose, and regimen. If participants had exacerbated from mild to moderate within 12 weeks, ICS was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466701|NCT00442559|E1|Reported Event|Montelukast|Participants were treated for 12 months after randomization: Participants 2 to 5 years of age took one 4 mg chewable tablet and 6 to 14 years of age took one 5 mg chewable tablet daily in the evening. If participants had exacerbated from mild to moderate within 12 weeks, inhaled corticosteroids (ICS) was added to Montelukast and ICS, respectively and those participants were excluded in the efficacy evaluation at 12 weeks.
466702|NCT00442546|B4|Baseline|Total|Total of all reporting groups
466703|NCT00442546|B3|Baseline|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466704|NCT00442546|B2|Baseline|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466705|NCT00442546|B1|Baseline|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466706|NCT00442546|P3|Participant Flow|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466707|NCT00442546|P2|Participant Flow|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466708|NCT00442546|P1|Participant Flow|Pregabalin (150 Milligrams [mg])|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on Post-Operative Day 1 (POD 1).
466711|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466712|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466713|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466714|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466715|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466716|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466717|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466718|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466719|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466720|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466721|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466722|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466723|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466724|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466725|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466726|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466727|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466728|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466729|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466730|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466731|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466732|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466733|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466734|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466735|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466736|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466737|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466738|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466739|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466740|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466741|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466742|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466743|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466744|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466745|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466746|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466747|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466748|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466749|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466750|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466751|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466752|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466753|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466754|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466755|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466756|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466757|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466758|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466759|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466760|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466761|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466762|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466763|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466764|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466765|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466766|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466767|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466768|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466769|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466770|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466771|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466772|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466773|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466774|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466775|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466776|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466777|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466778|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466779|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466780|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466781|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466782|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466783|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466784|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466785|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466786|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466787|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466788|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466789|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466790|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466791|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466792|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466793|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466794|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466795|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466796|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466797|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466798|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466799|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466800|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466801|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466802|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466803|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466804|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466805|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466806|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466807|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466808|NCT00442546|O1|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466809|NCT00442546|O2|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466810|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466811|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466812|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466813|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466814|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466815|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466816|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466817|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466818|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466819|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466820|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466821|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466822|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466823|NCT00442546|O3|Outcome|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466824|NCT00442546|O2|Outcome|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466825|NCT00442546|O1|Outcome|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466826|NCT00442546|E3|Reported Event|Placebo|Matching Placebo capsules orally: 1 dose the evening before surgery (approximately 12 hours prior to surgery), 1 dose approximately 2 hours before surgery followed by twice daily dosing for up to 6 post-operative weeks starting on POD 1.
466827|NCT00442546|E2|Reported Event|Pregabalin (300 mg)|Pregabalin capsules orally 150 mg the night before surgery (approximately 12 hours prior to surgery) followed by 150 mg approximately 2 hours before surgery followed by 300 mg/day (150 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466828|NCT00442546|E1|Reported Event|Pregabalin (150 mg)|Pregabalin capsules orally 75 mg the evening before surgery (approximately 12 hours prior to surgery) followed by 75 mg approximately 2 hours before surgery followed by 150 mg/day (75 mg twice daily) for up to 6 post-operative weeks starting on POD 1.
466829|NCT00442507|B1|Baseline|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466830|NCT00442507|P1|Participant Flow|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466831|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466832|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466910|NCT00442351|O1|Outcome|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
467224|NCT00441480|O2|Outcome|Control|Corn oil
466833|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466834|NCT00442507|O1|Outcome|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466835|NCT00442507|E1|Reported Event|Erlotinib and Avastin|Patients will be treated with erlotinib 150 mg oral daily and Avastin 15 mg/kg intravenously each cycle of therapy (each cycle is 21 days or every 3 weeks). The first infusion of Avastin will be administered over 90 minutes. If tolerated, the second infusion will be given over 60 minutes and in 30 minutes for the subsequent treatments. Treatment will be administered until disease progression or intolerable side effects.
466836|NCT00442468|B1|Baseline|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466837|NCT00442468|P1|Participant Flow|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466838|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466839|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466840|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466841|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466842|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466843|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466844|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466845|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466846|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466847|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466848|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466849|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466850|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466851|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466852|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466853|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466854|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466855|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466856|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466857|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466858|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466859|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466911|NCT00442351|E2|Reported Event|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
466860|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466861|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466862|NCT00442468|O1|Outcome|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466863|NCT00442468|E1|Reported Event|All Participants, With Self-reported Symptoms of Bronchitis|Participants with a minimum of 10 pack/year history of cigarette smoking and self-reported symptoms of chronic bronchitis in a primary care setting
466864|NCT00442416|B3|Baseline|Total|Total of all reporting groups
466865|NCT00442416|B2|Baseline|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466866|NCT00442416|B1|Baseline|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466867|NCT00442416|P2|Participant Flow|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466868|NCT00442416|P1|Participant Flow|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466869|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466870|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466871|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466872|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466873|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466874|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466875|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466912|NCT00442351|E1|Reported Event|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
466876|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466877|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466878|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466879|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466880|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466881|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466882|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466883|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466884|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466885|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466886|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466887|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466888|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466913|NCT00442338|B4|Baseline|Total|Total of all reporting groups
466914|NCT00442338|B3|Baseline|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
466915|NCT00442338|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
466916|NCT00442338|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg IV Administration
466917|NCT00442338|P3|Participant Flow|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
466889|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466890|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466891|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466892|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466893|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466894|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466895|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466896|NCT00442416|O2|Outcome|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466897|NCT00442416|O1|Outcome|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466898|NCT00442416|E2|Reported Event|Epoetin Alfa|Eligible participants were administered epoetin alfa SC as per the standard of care for eight months (TP and EP), and were followed-up for 15 days following the final study visit. Participants who self-administered/visited to clinics for ESA dosing prior to randomization continued to do so.
466899|NCT00442416|E1|Reported Event|RO0503821|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneously (SC) every month for eight months (6 months of titration period [TP] and two months of evaluation period [EP] and 15-days following the final study visit (9 months post randomization). The first dose of Mircera (120, 200, or 360 mcg) was based upon the dose of epoetin alfa received 1 to 2 weeks prior to administration of study drug, while subsequent doses were adjusted to maintain haemoglobin (Hb) concentrations within target of >=10.0 gram per decilitre (g/dL) and <=12.0 g/dL. Participants who self-administered/visited to clinics for erythropoiesis stimulating agent (ESA) dosing prior to randomization continued to do so.
466900|NCT00442364|B1|Baseline|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
466901|NCT00442364|P1|Participant Flow|Polidocanol 1% Injectable Microfoam|polidocanol injectable microfoam 1%
466902|NCT00442364|O1|Outcome|Safety Evaluable Population|polidocanol injectable foam 1% with circulating MCA bubbles present at MRI
466903|NCT00442364|E1|Reported Event|Safety Evaluable|patients treated with polidocanol 1% injectable foam with circulating bubbles present on MRI
466904|NCT00442351|B3|Baseline|Total|Total of all reporting groups
466905|NCT00442351|B2|Baseline|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
466906|NCT00442351|B1|Baseline|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
466907|NCT00442351|P2|Participant Flow|Placebo Inhaler|Placebo for Asmanex Twisthaler 220 mcg, provided once daily in the evening for 12 weeks
466908|NCT00442351|P1|Participant Flow|Asmanex Twisthaler|Asmanex Twisthaler 220 mcg provided once daily in the evening for 12 weeks
466922|NCT00442338|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg IV Administration
466923|NCT00442338|E3|Reported Event|Aminophylline 250 mg|Aminophylline 250 mg IV drip administration
466924|NCT00442338|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
466925|NCT00442338|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg IV Administration
466926|NCT00442169|B7|Baseline|Total|Total of all reporting groups
466927|NCT00442169|B6|Baseline|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466928|NCT00442169|B5|Baseline|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466929|NCT00442169|B4|Baseline|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466930|NCT00442169|B3|Baseline|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466931|NCT00442169|B2|Baseline|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466932|NCT00442169|B1|Baseline|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466933|NCT00442169|P6|Participant Flow|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466934|NCT00442169|P5|Participant Flow|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466935|NCT00442169|P4|Participant Flow|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466936|NCT00442169|P3|Participant Flow|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466937|NCT00442169|P2|Participant Flow|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466938|NCT00442169|P1|Participant Flow|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466939|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466940|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466941|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466942|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466943|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466944|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466945|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466946|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466947|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466948|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466949|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466950|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466951|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466952|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466953|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466954|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466955|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466956|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466957|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466958|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466959|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466960|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466961|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466962|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466963|NCT00442169|O6|Outcome|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466964|NCT00442169|O5|Outcome|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466965|NCT00442169|O4|Outcome|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466966|NCT00442169|O3|Outcome|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466967|NCT00442169|O2|Outcome|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466968|NCT00442169|O1|Outcome|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466969|NCT00442169|E6|Reported Event|WNO2 High Dose (Part 2)|Participants in Part 2 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466970|NCT00442169|E5|Reported Event|Placebo (Part 2)|Participants in Part 2 of the study who received a placebo vaccine on Day 0
466971|NCT00442169|E4|Reported Event|WN02 High Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466972|NCT00442169|E3|Reported Event|WN02 Medium Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 37000 plaque-forming units, on Day 0
466973|NCT00442169|E2|Reported Event|WN02 Low Dose (Part 1)|Participants in Part 1 of the study who received a single dose of West Nile Virus vaccine WN02, 3700 plaque-forming units, on Day 0
466974|NCT00442169|E1|Reported Event|Placebo (Part 1)|Participants in Part 1 of the study who received a single dose of saline on Day 0
466975|NCT00442117|B3|Baseline|Total|Total of all reporting groups
466976|NCT00442117|B2|Baseline|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466977|NCT00442117|B1|Baseline|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466978|NCT00442117|P2|Participant Flow|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466979|NCT00442117|P1|Participant Flow|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466980|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466981|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466982|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466983|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466984|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466985|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466986|NCT00442117|O2|Outcome|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466987|NCT00442117|O1|Outcome|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466988|NCT00442117|E2|Reported Event|BUD-DPI|Budesonide Dry Powder Inhaler (BUD DPI) 200 mcg, two puffs twice daily (total of 800 mcg/day)
466989|NCT00442117|E1|Reported Event|MF-DPI|Mometasone Furoate Dry Powder Inhaler (MF DPI) 200 mcg, two puffs once daily in the evening (PM) (total of 400 mcg/day)
466990|NCT00442013|B3|Baseline|Total|Total of all reporting groups
466991|NCT00442013|B2|Baseline|Placebo Group|Matching placebo
466992|NCT00442013|B1|Baseline|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
466993|NCT00442013|P2|Participant Flow|Placebo Group|Matching placebo with no active ingredients. Either 1 or 2 tablets per day, depending on weight, in the evening before a meal
466994|NCT00442013|P1|Participant Flow|Lansoprazole Group|15 mg/day by mouth for children weighing less than 30kg, one tablet per day in the evening before a meal 30 mg/day by mouth for children weighing 30 kg or more, two tablets per day in the evening before a meal
466995|NCT00442013|O2|Outcome|Placebo Group|matching placebo
466996|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
466997|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
466998|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
466999|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
467000|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
467001|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
467002|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
467003|NCT00442013|O2|Outcome|Placebo Group|Matching placebo
467004|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
467005|NCT00442013|O2|Outcome|Placebo Group|matching placebo
467006|NCT00442013|O1|Outcome|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
467007|NCT00442013|E2|Reported Event|Placebo Group|Matching placebo
467008|NCT00442013|E1|Reported Event|Lansoprazole Group|15 mg/day for children weighing less than 30kg 30 mg/day for children weighing 30 kg or more
467009|NCT00441974|B1|Baseline|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
467010|NCT00441974|P1|Participant Flow|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
467011|NCT00441974|O1|Outcome|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
467012|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467013|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
467014|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467015|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
467016|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467017|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467018|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467019|NCT00441974|O3|Outcome|Total|Total of HBeAg+ and HBeAg- participants
467020|NCT00441974|O2|Outcome|HBeAg- at Baseline|Participants who had undetectable HBeAg as measured by a local laboratory
467021|NCT00441974|O1|Outcome|HBeAg+ at Baseline|Participants who had detectable HBeAg (Hepatitis B e Antigens) as measured by a local laboratory
467022|NCT00441974|E1|Reported Event|10 mg Adefovir Dipivoxil|Adefovir Dipivoxil (ADV) 10 mg tablets once daily for 48 weeks
467023|NCT00441792|B3|Baseline|Total|Total of all reporting groups
467024|NCT00441792|B2|Baseline|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
467025|NCT00441792|B1|Baseline|Midazolam|Patients received either etomidate or midazolam.
467026|NCT00441792|P2|Participant Flow|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
467027|NCT00441792|P1|Participant Flow|Midazolam|Patients received either etomidate or midazolam.
467028|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
467029|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
467030|NCT00441792|O2|Outcome|Etomidate|Patients received etomidate (0.3 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
467031|NCT00441792|O1|Outcome|Midazolam|Patients received midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients' care, both in the emergency department and in the intensive care unit, was directed according to the treating physician.
467032|NCT00441792|E2|Reported Event|Etomidate|Patients received either etomidate (0.3 mg/kg) or midazolam (0.1 mg/kg) intravenously before rapid sequence intubation in a double-blind fashion. The dose of each medication was chosen according to current physician practice and previous study findings. Identical study vials containing either etomidate or midazolam, in volume-equivalent concentrations, were prepared by our pharmacy department and stored in kits that also contained a variety of commonly used paralytic agents. Kits were labeled with numbers that reflected the assignment generated by a randomization sequence generator and placed in our automated medication dispensing cabinet (Omnicell, Inc., Mountain View, CA). The remainder of the patients’ care, both in the ED and in the ICU, was directed according to the treating physician.
467033|NCT00441792|E1|Reported Event|Midazolam|Patients received either etomidate or midazolam.
467034|NCT00441766|B5|Baseline|Total|Total of all reporting groups
467035|NCT00441766|B4|Baseline|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467036|NCT00441766|B3|Baseline|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467037|NCT00441766|B2|Baseline|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467038|NCT00441766|B1|Baseline|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467039|NCT00441766|P4|Participant Flow|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467040|NCT00441766|P3|Participant Flow|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467041|NCT00441766|P2|Participant Flow|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467042|NCT00441766|P1|Participant Flow|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467043|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467044|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467045|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467046|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467047|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467048|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467049|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467050|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467051|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467052|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467053|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467054|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467055|NCT00441766|O4|Outcome|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467056|NCT00441766|O3|Outcome|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467057|NCT00441766|O2|Outcome|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467058|NCT00441766|O1|Outcome|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467059|NCT00441766|E4|Reported Event|Placebo|Part A: Placebo capsule every 12 hours for 4 weeks
467060|NCT00441766|E3|Reported Event|AGN 203818 3 mg|Part A: AGN 203818 3 mg capsule every 12 hours for 4 weeks
467061|NCT00441766|E2|Reported Event|AGN 203818 20 mg|Part A: AGN 203818 20mg capsule every 12 hours for 4 weeks
467062|NCT00441766|E1|Reported Event|AGN 203818 60 mg|Part A: AGN 203818 60mg capsule every 12 hours for 4 weeks
467063|NCT00441727|B4|Baseline|Total|Total of all reporting groups
467064|NCT00441727|B3|Baseline|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467065|NCT00441727|B2|Baseline|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467066|NCT00441727|B1|Baseline|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467067|NCT00441727|P3|Participant Flow|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467068|NCT00441727|P2|Participant Flow|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467069|NCT00441727|P1|Participant Flow|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467070|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467071|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467072|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467073|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467074|NCT00441727|O2|Outcome|Esomeproazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (acetylsalicyclic acid) (75-325 mg)
467075|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467076|NCT00441727|O3|Outcome|Placbo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467077|NCT00441727|O2|Outcome|Esomeprazole 20 mg|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467078|NCT00441727|O1|Outcome|Esomeprazole 40 mg|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467079|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467080|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467081|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467082|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467083|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467084|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467085|NCT00441727|O3|Outcome|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467086|NCT00441727|O2|Outcome|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467087|NCT00441727|O1|Outcome|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467088|NCT00441727|E3|Reported Event|Placebo|Placebo every day for 26 weeks in subjects on continuous low-dose ASA (75-325 mg)
467089|NCT00441727|E2|Reported Event|Esomeproazole 20|Esomeprazole 20 mg every day for 26 weeks in subjects on continuous low dose ASA (75-325 mg)
467090|NCT00441727|E1|Reported Event|Esomeprazole 40|Esomeprazole 40 mg every day for 26 weeks in subjects on continuous low-dose ASA (acetylsalicyclic acid) (75-325 mg)
467091|NCT00441701|B11|Baseline|Total|Total of all reporting groups
467092|NCT00441701|B10|Baseline|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467093|NCT00441701|B9|Baseline|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467094|NCT00441701|B8|Baseline|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467095|NCT00441701|B7|Baseline|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467096|NCT00441701|B6|Baseline|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467097|NCT00441701|B5|Baseline|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467098|NCT00441701|B4|Baseline|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467099|NCT00441701|B3|Baseline|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467100|NCT00441701|B2|Baseline|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467101|NCT00441701|B1|Baseline|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467102|NCT00441701|P10|Participant Flow|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467103|NCT00441701|P9|Participant Flow|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467104|NCT00441701|P8|Participant Flow|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467105|NCT00441701|P7|Participant Flow|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467106|NCT00441701|P6|Participant Flow|Part 1: Placebo to Navarixin 30 mg|Cohort 3: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467107|NCT00441701|P5|Participant Flow|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467108|NCT00441701|P4|Participant Flow|Part 1: Placebo to Navarixin 10 mg|Cohort 2: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467109|NCT00441701|P3|Participant Flow|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467110|NCT00441701|P2|Participant Flow|Part 1: Placebo to Navarixin 3 mg|Cohort 1: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467111|NCT00441701|P1|Participant Flow|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) once daily (QD) for up to 12 weeks
467112|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467113|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467114|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467115|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467116|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467117|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467118|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467119|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467120|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467121|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467122|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467123|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467124|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467125|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467126|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467127|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467128|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467129|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467130|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467131|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467132|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467133|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467134|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467135|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467136|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467137|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467138|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467139|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467140|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467141|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467142|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467143|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467144|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467145|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467146|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467147|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467148|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467149|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467150|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467151|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467152|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467153|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467154|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467155|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467156|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467157|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467158|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467159|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467160|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467161|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467162|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467163|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467164|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467165|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467166|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467167|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467168|NCT00441701|O4|Outcome|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467169|NCT00441701|O3|Outcome|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467170|NCT00441701|O2|Outcome|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467171|NCT00441701|O1|Outcome|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467172|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467173|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467174|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467175|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467176|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467177|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467178|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467179|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467180|NCT00441701|O4|Outcome|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467181|NCT00441701|O3|Outcome|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467182|NCT00441701|O2|Outcome|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467183|NCT00441701|O1|Outcome|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467184|NCT00441701|E8|Reported Event|Part 2: Placebo to Navarixin|Cohort 4: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467185|NCT00441701|E7|Reported Event|Part 2: Navarixin 30 mg|Cohort 4: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467186|NCT00441701|E6|Reported Event|Part 2: Navarixin 10 mg|Cohort 4: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467187|NCT00441701|E5|Reported Event|Part 2: Navarixin 3 mg|Cohort 4: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467188|NCT00441701|E4|Reported Event|Part 1: Placebo to Navarixin (Pooled)|Pooled Placebo Cohorts: Participants receive placebo to navarixin (three capsules) QD for up to 12 weeks
467189|NCT00441701|E3|Reported Event|Part 1: Navarixin 30 mg|Cohort 3: Participants receive navarixin 30 mg (three 10 mg capsules) QD for up to 12 weeks
467190|NCT00441701|E2|Reported Event|Part 1: Navarixin 10 mg|Cohort 2: Participants receive navarixin 10 mg (one 10 mg capsule and two placebo capsules) QD for up to 12 weeks
467191|NCT00441701|E1|Reported Event|Part 1: Navarixin 3 mg|Cohort 1: Participants receive navarixin 3 mg (three 1 mg capsules) QD for up to 12 weeks
467192|NCT00441584|B1|Baseline|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
467193|NCT00441584|P1|Participant Flow|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
467194|NCT00441584|O1|Outcome|PegIntron Plus Rebetol|PegIntron 1.5 μg/kg/week plus Rebetol 800-1400 mg/day administered for 48 weeks
467195|NCT00441584|E1|Reported Event|PegIntron Plus REBETOL|
467196|NCT00441558|B1|Baseline|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
467197|NCT00441558|P1|Participant Flow|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
467198|NCT00441558|O1|Outcome|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
467199|NCT00441558|E1|Reported Event|Flibanserin|Flibanserin: flexible dosing of either 50 or 100mg every evening, or 25 or 50mg twice daily.
467200|NCT00441545|B1|Baseline|Entire Study Population|
467201|NCT00441545|P2|Participant Flow|Sevelamer HCl First|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
467202|NCT00441545|P1|Participant Flow|Fosrenol First|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
467203|NCT00441545|O2|Outcome|Sevelamer HCl|
467204|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
467205|NCT00441545|O2|Outcome|Sevelamer HCl|
467206|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
467207|NCT00441545|O2|Outcome|Sevelamer HCl|
467208|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
467209|NCT00441545|O2|Outcome|Sevelamer HCl|
467210|NCT00441545|O1|Outcome|Fosrenol|Lanthanum carbonate
467211|NCT00441545|E2|Reported Event|Sevelamer HCl|Sevelamer HCl dosing began at 4800mg/day, administered orally as two 800mg tablets taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 6400mg/day, administered orally as three 800mg tablets taken two times per day with meals and two 800mg tablets taken once per day with the lighter meal (i.e., a total of eight 800mg tablets per day). Subjects were to remain on the final sevelamer HCl dose of 6400mg/day for 3 weeks. After washout, patients then crossover to receive Fosrenol for 4 weeks (see above).
467212|NCT00441545|E1|Reported Event|Fosrenol|Fosrenol (Lanthanum carbonate) dosing began at 2250mg/day, administered orally as one 750mg tablet taken three times per day with meals for 1 week. After receiving this dose for 1 week, subjects received the final dose of 3000mg/day, administered orally as one 1000mg tablet three times per day with meals. Subjects were to remain on the final Fosrenol dose of 3000mg/day for 3 weeks. After washout, patients then crossover to receive Sevelamer HCl for 4 weeks (see below).
467213|NCT00441480|B3|Baseline|Total|Total of all reporting groups
467214|NCT00441480|B2|Baseline|Control|Corn oil
467215|NCT00441480|B1|Baseline|PS-FO|plant sterols esterified to fish oil fatty acids
467216|NCT00441480|P2|Participant Flow|Control|Corn oil
467217|NCT00441480|P1|Participant Flow|PS-FO|plant sterols esterified to fish oil fatty acids
467218|NCT00441480|O2|Outcome|Control|Corn oil
467219|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467220|NCT00441480|O2|Outcome|Control|Corn oil
467221|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467222|NCT00441480|O2|Outcome|Control|Corn oil
467223|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467225|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467226|NCT00441480|O2|Outcome|Control|Corn oil
467227|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467228|NCT00441480|O2|Outcome|Control|Corn oil
467229|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467230|NCT00441480|O2|Outcome|Control|Corn oil
467231|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467232|NCT00441480|O2|Outcome|Control|Corn oil
467233|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467234|NCT00441480|O2|Outcome|Control|Corn oil
467235|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467236|NCT00441480|O2|Outcome|Control|Corn oil
467237|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467238|NCT00441480|O2|Outcome|Control|Corn oil
467239|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467240|NCT00441480|O2|Outcome|Control|Corn oil
467241|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467242|NCT00441480|O2|Outcome|Control|Corn oil
467243|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467244|NCT00441480|O2|Outcome|Control|Corn oil
467245|NCT00441480|O1|Outcome|PS-FO|plant sterols esterified to fish oil fatty acids
467246|NCT00441480|E2|Reported Event|Control|Corn oil
467247|NCT00441480|E1|Reported Event|PS-FO|plant sterols esterified to fish oil fatty acids
467248|NCT00441467|B1|Baseline|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467249|NCT00441467|P1|Participant Flow|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467250|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467251|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467252|NCT00441467|O1|Outcome|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467253|NCT00441467|E1|Reported Event|Glufosfamide|"Glufosfamide~Glufosfamide: 5000 mg/m2 of glufosfamide on Day 1 of each three-week cycle for up to 6 cycles."
467254|NCT00441441|B3|Baseline|Total|Total of all reporting groups
467255|NCT00441441|B2|Baseline|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467256|NCT00441441|B1|Baseline|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467257|NCT00441441|P2|Participant Flow|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467258|NCT00441441|P1|Participant Flow|Fluticasone Propionate/Salmeterol Hydrofluoroalkane (HFA)|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467259|NCT00441441|O2|Outcome|No Spacer|Participants who required a spacer and were in either treatment group
467260|NCT00441441|O1|Outcome|Spacer|Participants who did not use spacer and were in either treatment group
467261|NCT00441441|O2|Outcome|Spacer|Participants who required a spacer and were in either treatment group
467262|NCT00441441|O1|Outcome|No Spacer|Participants who did not use spacer and were in either treatment group
467263|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467264|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467265|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467266|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Samples provided by participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467267|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467268|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467269|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467270|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467271|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467272|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467273|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467274|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467537|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467275|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467276|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467277|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467278|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467279|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
467280|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
467281|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
467282|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
467283|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
467284|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
467285|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
467286|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
467287|NCT00441441|O4|Outcome|Fluticasone Propionate HFA - No Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks
467288|NCT00441441|O3|Outcome|Fluticasone Propionate HFA - Spacer|Fluticasone Propionate 100 µg HFA (2 inhalation of 50 µg) twice daily in participants 4-11 years of age for 12 weeks. Participants who also used Spacers
467289|NCT00441441|O2|Outcome|Fluticasone Propionate/Salmeterol HFA - No Spacer|Fluticasone propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg) twice daily in participants 4-11 years of age for 12 weeks
467290|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA - Spacer|Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg) twice daily in participants 4-11 years of age for 12 weeks - Participants who also used Spacers
467291|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467292|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467293|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467294|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467295|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467296|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467297|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467298|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467299|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467300|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 µg HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467301|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467302|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467303|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone propionate 100 µg HFA (2inhalations of 50 µg), twice daily for 12 weeks.
467304|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
467305|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467306|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25µg), twice daily for 12 weeks.
467307|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467308|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467309|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467310|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467311|NCT00441441|O2|Outcome|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467312|NCT00441441|O1|Outcome|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467313|NCT00441441|E2|Reported Event|Fluticasone Propionate HFA|Participants who were randomly assigned to Fluticasone Propionate 100 µg HFA (2 inhalations of 50 µg), twice daily for 12 weeks.
467314|NCT00441441|E1|Reported Event|Fluticasone Propionate/Salmeterol HFA|Participants who were randomly assigned to Fluticasone Propionate/salmeterol 100/50 micrograms (µg) HFA (2 inhalations of 50/25 µg), twice daily for 12 weeks.
467315|NCT00441363|B3|Baseline|Total|Total of all reporting groups
467316|NCT00441363|B2|Baseline|Placebo|matching placebo
467317|NCT00441363|B1|Baseline|Cycloset|0.8 mg tablet
467318|NCT00441363|P2|Participant Flow|Placebo|matching placebo
467319|NCT00441363|P1|Participant Flow|Cycloset|0.8 mg tablet
467320|NCT00441363|O2|Outcome|Placebo|matching placebo
467321|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
467322|NCT00441363|O2|Outcome|Placebo|matching placebo
467323|NCT00441363|O1|Outcome|Cycloset|0.8 mg tablet
467324|NCT00441363|E2|Reported Event|Placebo|matching placebo
467325|NCT00441363|E1|Reported Event|Cycloset|0.8 mg tablet
467326|NCT00441337|B5|Baseline|Total|Total of all reporting groups
467327|NCT00441337|B4|Baseline|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467328|NCT00441337|B3|Baseline|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467329|NCT00441337|B2|Baseline|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467330|NCT00441337|B1|Baseline|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467331|NCT00441337|P4|Participant Flow|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467332|NCT00441337|P3|Participant Flow|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467333|NCT00441337|P2|Participant Flow|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467420|NCT00441285|P2|Participant Flow|PK Substudy ABZ+Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467463|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467334|NCT00441337|P1|Participant Flow|0.3 mg/kg Nivolumab|0.3 milligrams (mg) of nivolumab per kilogram (kg) of body weight (mg/kg) was administered in a single intravenous (IV) infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467335|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467336|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467337|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467338|NCT00441337|O3|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467339|NCT00441337|O2|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467340|NCT00441337|O1|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467341|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467342|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467343|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467344|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467345|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467464|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467465|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467346|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467347|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467348|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467349|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467350|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467351|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467352|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467353|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467354|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467355|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467356|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467357|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467421|NCT00441285|P1|Participant Flow|PK Substudy ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467358|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467359|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467360|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467361|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467362|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467363|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467364|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467365|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467366|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467367|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467368|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467369|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467422|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
467423|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
467424|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
467425|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
467370|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467371|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467372|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467373|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467374|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467375|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467376|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467377|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467378|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467379|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467380|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467381|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467426|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
467427|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
467428|NCT00441285|O3|Outcome|Phase III Trial - Standard ABZ|Main Trial, Arm receiving standard ABZ doses, no PZQ
467429|NCT00441285|O2|Outcome|Phase III Trial - Increased ABZ|Main Trial, Arm receiving increased ABZ doses, no PZQ
467382|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467383|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467384|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467385|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467386|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467387|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467388|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467389|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467390|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467391|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467392|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467393|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467430|NCT00441285|O1|Outcome|Phase III Trial - ABZ+PZQ|Main Trial, Arm receiving standard ABZ doses plus active PZQ
467431|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467394|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467395|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467396|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467397|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467398|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467399|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467400|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467401|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467402|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no CR or PR was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either PD or 2 years elapsed.
467403|NCT00441337|O4|Outcome|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467404|NCT00441337|O3|Outcome|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467405|NCT00441337|O2|Outcome|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467461|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467533|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467406|NCT00441337|O1|Outcome|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight (mg/kg) was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467407|NCT00441337|E4|Reported Event|10 mg/kg Nivolumab|10 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467408|NCT00441337|E3|Reported Event|3 mg/kg Nivolumab|3 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467409|NCT00441337|E2|Reported Event|1 mg/kg Nivolumab|1 mg of nivolumab per kg of body weight was administered in a single IV infusion over 60 minutes on Day 1. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467410|NCT00441337|E1|Reported Event|0.3 mg/kg Nivolumab|0.3 mg of nivolumab per kg of body weight was administered in a single IV infusion on Day 1 with 10% of the dose infused over 6 minutes and after a 1 hour observation period, the balance was administered over 60 minutes. Eligible participants could be re-treated and receive 2 more doses (1 dose every 4 weeks) at same dose as the single dose if: disease was stable, no drug intolerance was observed, no complete response (CR) or partial response (PR) was observed, or they had a positive immunogenicity sample within 4 weeks prior to re-treatment. Those who responded to therapy with a CR or PR were eligible for long-term follow-up until either progressive disease (PD) or 2 years elapsed.
467411|NCT00441285|B6|Baseline|Total|Total of all reporting groups
467412|NCT00441285|B5|Baseline|Phase III Trial Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete the doses to the dosage in the Increased ABZ arm~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
467413|NCT00441285|B4|Baseline|Phase III Trial Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 10 days."
467414|NCT00441285|B3|Baseline|Phase III Trial ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~A placebo of ABZ was added to complete to the doses in the Increased ABZ arm~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 10 days."
467415|NCT00441285|B2|Baseline|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467416|NCT00441285|B1|Baseline|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467417|NCT00441285|P5|Participant Flow|Phase III Trial - Standard ABZ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Placebo of Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467418|NCT00441285|P4|Participant Flow|Phase III Trial - Increased ABZ|"Albendazole was given at 22.5 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum of 1200 mg / d, for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening. It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467419|NCT00441285|P3|Participant Flow|Phase III Trial - ABZ+PZQ|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Placebo of ABZ was added to mask the dose of ABZ (see Increased ABZ arm)~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467462|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467432|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467433|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467434|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467435|NCT00441285|O2|Outcome|Phenytoin|Area Under the Curve of Praziquantel in Patients Receiving Phenytoin
467436|NCT00441285|O1|Outcome|Carbamazepine|Area Under the Curve of Praziquantel in Patients Receiving Carbamazepine
467437|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg/kg/day, divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg/day, for 10 days.~Praziquantel was given at 50 mg/kg/day, divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g/day,for 9 1/2 days."
467438|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467439|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467440|NCT00441285|O2|Outcome|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467441|NCT00441285|O1|Outcome|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467442|NCT00441285|E2|Reported Event|Albendazole + Placebo|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel placebo was given in two daily doses, morning and evening,for 9 1/2 days."
467443|NCT00441285|E1|Reported Event|Albendazole + Praziquantel|"Albendazole was given at 15 mg / kg / d , divided two daily doses, morning and evening. It is supplied in 200 mg tablets, so the dose was rounded up to the next 100 mg level, up to a maximum 800 mg / d , for 10 days.~Praziquantel was given at 50 mg / kg / d , divided in two daily doses, morning and evening.It is supplied in 600 mg tablets divided in four, so the dose was rounded up to the next 100 mg level, up to a maximum 3.6 g / d , for 9 1/2 days."
467444|NCT00441272|B3|Baseline|Total|Total of all reporting groups
467445|NCT00441272|B2|Baseline|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
467446|NCT00441272|B1|Baseline|Placebo|Those participants receiving placebo for 48 weeks
467447|NCT00441272|P2|Participant Flow|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
467448|NCT00441272|P1|Participant Flow|Placebo|Those participants receiving placebo for 48 weeks
467449|NCT00441272|O2|Outcome|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
467450|NCT00441272|O1|Outcome|Placebo|Those participants receiving placebo for 48 weeks
467451|NCT00441272|E2|Reported Event|Pioglitazone 45mg/Day|Those participants receiveing Pioglitazone 45mg/day for 48 weeks.
467452|NCT00441272|E1|Reported Event|Placebo|Those participants receiving placebo for 48 weeks
467453|NCT00441259|B3|Baseline|Total|Total of all reporting groups
467454|NCT00441259|B2|Baseline|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467455|NCT00441259|B1|Baseline|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467456|NCT00441259|P2|Participant Flow|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467457|NCT00441259|P1|Participant Flow|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467458|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467459|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467460|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
468122|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
467466|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467467|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467468|NCT00441259|O2|Outcome|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467469|NCT00441259|O1|Outcome|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467470|NCT00441259|E2|Reported Event|Mouse Brain Derived Vaccine|Participants received 2 doses of Japanese encephalitis inactivated mouse brain derived vaccine: 1 dose on Day 0 and 1 dose on Day 14.
467471|NCT00441259|E1|Reported Event|ChimeriVax™-JE|Participants received one dose of placebo on Day 0 followed by one dose of Japanese encephalitis chimeric virus vaccine (ChimeriVax™-JE) on Day 14.
467472|NCT00441168|B3|Baseline|Total|Total of all reporting groups
467473|NCT00441168|B2|Baseline|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467474|NCT00441168|B1|Baseline|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467475|NCT00441168|P2|Participant Flow|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467476|NCT00441168|P1|Participant Flow|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467477|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467478|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467479|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467480|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467481|NCT00441168|O2|Outcome|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467482|NCT00441168|O1|Outcome|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467483|NCT00441168|E2|Reported Event|PAD Treatment|bortezomib: 1.3 mg/m² intravenous (IV) bolus on days 1, 4, 8, and 11; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467484|NCT00441168|E1|Reported Event|VAD Treatment|vincristine: 0.4mg IV push on days 1 to 4; adriamycin: 9mg/m² IV push on days 1 to 4; dexamethasone: 40 mg daily days 1- 4/9-12/17-20 - cycle 1 / days 1-4/17-20 - subsequent cycle
467485|NCT00441142|B5|Baseline|Total|Total of all reporting groups
467486|NCT00441142|B4|Baseline|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467487|NCT00441142|B3|Baseline|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467488|NCT00441142|B2|Baseline|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467534|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467535|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467489|NCT00441142|B1|Baseline|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467490|NCT00441142|P4|Participant Flow|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467491|NCT00441142|P3|Participant Flow|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467492|NCT00441142|P2|Participant Flow|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467493|NCT00441142|P1|Participant Flow|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467494|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467495|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467496|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467621|NCT00440947|B1|Baseline|ABC/3TC + ATV/r|All participants starting the Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467497|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467498|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467499|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467500|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467501|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467502|NCT00441142|O4|Outcome|Phase II: Arm B (Experimental Group: RT + TMZ + Vandetanib)|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467503|NCT00441142|O3|Outcome|Phase II: Arm A (Control Group: RT + TMZ)|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467504|NCT00441142|O2|Outcome|Phase I: Dose Level -2: RT + TMZ + Vandetanib @ 100 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467536|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467505|NCT00441142|O1|Outcome|Phase I: Dose Level -1: RT + TMZ + Vandetanib @ 200 mg/Day|"ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant's RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467506|NCT00441142|E2|Reported Event|Phase II-Arm A Pts (Control Group): RT + TMZ|"The Induction Phase:~Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given]."
467507|NCT00441142|E1|Reported Event|Phase I & Phase II-Arm B Pts: RT + TMZ + Vandetanib|"The Induction Phase:~ZD6474 (Vandetanib) daily (to begin 5-7 days prior to starting participant’s RT) Temozolomide (75 mg/m2 daily for 6 weeks) with concurrent fractionated radiation therapy for approximately 6 weeks (XRT must be given by external beam to a partial brain field in daily fractions of 180-200 cGy, to a planned total dose to the tumor of approximately 6000 cGy), followed by 4-6 weeks rest.~Followed by the Maintenance Phase:~12 cycles of adjuvant temozolomide [at 150 mg/m2/day orally for 5 days (days 1-5) of a 28-day TMZ cycle; if 150 mg/m2/day is tolerated without difficulty and the investigator feels the patient can tolerate 200 mg/m2/day, then an increase to a maximum of 200 mg/m2/day for five days every 28 days may be given].~ZD6474 (Vandetanib) daily for the twelve (12) 28-day cycles of adjuvant temozolomide, with the option to continue until participant experiences an unacceptable toxicity or his/her tumor progresses."
467508|NCT00441116|B3|Baseline|Total|Total of all reporting groups
467509|NCT00441116|B2|Baseline|Placebo|Subjects who were given no Investigational product.
467510|NCT00441116|B1|Baseline|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467511|NCT00441116|P2|Participant Flow|Placebo|Subjects who were given no Investigational product.
467512|NCT00441116|P1|Participant Flow|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467513|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467514|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467515|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467516|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467517|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467518|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467519|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467520|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467521|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467522|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467523|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467524|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467525|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467526|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467527|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467528|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467529|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467530|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467531|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467532|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467538|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467539|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467540|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467541|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467542|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467543|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467544|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467545|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467546|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467547|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467548|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467549|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467550|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467551|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467552|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467553|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467554|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467555|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467556|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467557|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467558|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467559|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467560|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467561|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467562|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467563|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467564|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467565|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467566|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467567|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467568|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467569|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467570|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467571|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467572|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467573|NCT00441116|O2|Outcome|Placebo|Subjects who were given no Investigational product.
467574|NCT00441116|O1|Outcome|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467575|NCT00441116|E2|Reported Event|Placebo|Subjects who were given no Investigational product.
467576|NCT00441116|E1|Reported Event|Dutasteride|Subjects who were given 0.5mg of Dutasteride once daily for 6 months in male subjects age 18-49 years with Androgenetic Alopecia(AGA) in the vertex region, types IIIv, IV and V according to the modified Norwood-Hamilton Classification.
467577|NCT00441103|B3|Baseline|Total|Total of all reporting groups
467578|NCT00441103|B2|Baseline|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467579|NCT00441103|B1|Baseline|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
467580|NCT00441103|P2|Participant Flow|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467581|NCT00441103|P1|Participant Flow|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 microgram (mcg) administered subcutaneously three times a week for 40 weeks.
467582|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467583|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
467584|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467585|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
467586|NCT00441103|O1|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467587|NCT00441103|O2|Outcome|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467588|NCT00441103|O1|Outcome|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
467589|NCT00441103|E2|Reported Event|Placebo/RNF|Matching placebo administered subcutaneously three times a week for 16 weeks, followed by RNF 44 mcg administered subcutaneously three times a week for subsequent 24 weeks.
467590|NCT00441103|E1|Reported Event|Rebif® New Formulation (IFN-beta-1a, RNF)|RNF 44 mcg administered subcutaneously three times a week for 40 weeks.
467591|NCT00441064|B3|Baseline|Total|Total of all reporting groups
467592|NCT00441064|B2|Baseline|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
467593|NCT00441064|B1|Baseline|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
467594|NCT00441064|P2|Participant Flow|Diet Sequence High/Low Sodium|Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and crossed over to the low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]
467595|NCT00441064|P1|Participant Flow|Diet Sequence Low/High Sodium|Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks who crossed over to the high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
467596|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
467597|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
467598|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
467599|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
467600|NCT00441064|O2|Outcome|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet
467601|NCT00441064|O1|Outcome|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet
467602|NCT00441064|E2|Reported Event|High Sodium Diet|All patients who were on high sodium (>= 200 mmol/day) diet.
467603|NCT00441064|E1|Reported Event|Low Sodium Diet|All patients who were on low sodium (<= 100 mmol/day) diet.
467604|NCT00441012|B3|Baseline|Total|Total of all reporting groups
467605|NCT00441012|B2|Baseline|COMVAX™|"COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)~3 participants in the COMVAX™ group vaccinated but not randomized; overall N is 276, not 273 - due to issues randomizing via IVRS, in violation, all 3 participants were vaccinated as randomly assigned by the Investigator."
467606|NCT00441012|B1|Baseline|Modified Process Vaccine|"Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)~1 participant randomized but not vaccinated in the Modified Process Vaccine group; overall N is 269, not 270."
467607|NCT00441012|P2|Participant Flow|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467608|NCT00441012|P1|Participant Flow|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467609|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467610|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467611|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467612|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467613|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467614|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467615|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467616|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467617|NCT00441012|O2|Outcome|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467618|NCT00441012|O1|Outcome|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467619|NCT00441012|E2|Reported Event|COMVAX™|COMVAX™ (0, 2, and 10 months), 5/7.5 µg (micrograms)
467620|NCT00441012|E1|Reported Event|Modified Process Vaccine|Modified Process Vaccine (0, 2, and 10 months), 5/7.5 µg (micrograms)
467622|NCT00440947|P5|Participant Flow|ABC/3TC + ATV/r: Extension Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467623|NCT00440947|P4|Participant Flow|ABC/3TC + ATV: Extension Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467624|NCT00440947|P3|Participant Flow|ABC/3TC + ATV/r: Randomization Phase|Continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467625|NCT00440947|P2|Participant Flow|ABC/3TC + ATV: Randomization Phase|Simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with 400 mg ATV QD
467626|NCT00440947|P1|Participant Flow|ABC/3TC + ATV/r: Induction Phase|Abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467627|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467628|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467629|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467630|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467631|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467632|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467633|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467634|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467635|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467636|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467637|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467638|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467639|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467640|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467641|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467642|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467643|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467644|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467645|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467646|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467647|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467648|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467649|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467650|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467651|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467652|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467653|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467654|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467655|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467656|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467990|NCT00440050|B1|Baseline|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
467657|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467658|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467659|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467660|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467661|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467662|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Extension Phase|Extension Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467663|NCT00440947|O1|Outcome|ABC/3TC + ATV: Extension Phase|Extension Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467664|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467665|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467666|NCT00440947|O1|Outcome|ABC/3TC + ATV/r: Induction Phase|Induction Phase: ABC 600 mg/3TC 300 mg FDC tablet QD plus ATV 300 mg QD + /r 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467667|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467668|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467669|NCT00440947|O2|Outcome|ABC/3TC + ATV/r: Randomized Phase|Randomized Phase: continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD
467670|NCT00440947|O1|Outcome|ABC/3TC + ATV: Randomized Phase|Randomized Phase: simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD
467671|NCT00440947|E5|Reported Event|ABC/3TC + ATV/r: Extension Phase|participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV/r QD
467672|NCT00440947|E4|Reported Event|ABC/3TC + ATV: Extension Phase|Extension Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 60 weeks in combination with ATV QD
467673|NCT00440947|E3|Reported Event|ABC/3TC + ATV/r: Randomization Phase|Randomization Phase: participants in the Safety Population receiving continuation of ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV/r QD; includes SAEs that occurred during induction phase
467674|NCT00440947|E2|Reported Event|ABC/3TC + ATV: Randomization Phase|Randomization Phase: participants in the Safety Population receiving a simplification regimen of the ABC/3TC FDC tablet administered QD for an additional 48 weeks in combination with ATV QD; includes serious adverse events (SAEs) that occurred during induction phase
467675|NCT00440947|E1|Reported Event|ABC/3TC + ATV/r: Induction Phase|Induction Phase: participants in the Safety Population (participants exposed to at least one dose of investigational product) receiving abacavir (ABC) 600 milligrams (mg)/lamivudine (3TC) 300 mg fixed-dose combination tablet (FDC) once a day (QD) plus atazanavir (ATV) 300 mg QD + ritonavir (/r) 100 mg QD during the first 36 weeks of the study (planned interim analysis)
467676|NCT00440830|B5|Baseline|Total|Total of all reporting groups
467677|NCT00440830|B4|Baseline|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467678|NCT00440830|B3|Baseline|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467679|NCT00440830|B2|Baseline|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467680|NCT00440830|B1|Baseline|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467681|NCT00440830|P4|Participant Flow|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467682|NCT00440830|P3|Participant Flow|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467683|NCT00440830|P2|Participant Flow|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467684|NCT00440830|P1|Participant Flow|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467685|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467686|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467687|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467688|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467689|NCT00440830|O4|Outcome|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467690|NCT00440830|O3|Outcome|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467691|NCT00440830|O2|Outcome|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467692|NCT00440830|O1|Outcome|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467693|NCT00440830|E4|Reported Event|Non-smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467694|NCT00440830|E3|Reported Event|Non-smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of nonsmoking patients.
467695|NCT00440830|E2|Reported Event|Smokers-placebo|Placebo patch was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467696|NCT00440830|E1|Reported Event|Smokers-nicotine|Nicotine patch (0,5,10 or 15mg/day) was applied to hairless skin away from the surgical site 1 hour before induction of smoking patients.
467697|NCT00440700|B4|Baseline|Total|Total of all reporting groups
467698|NCT00440700|B3|Baseline|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467699|NCT00440700|B2|Baseline|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467700|NCT00440700|B1|Baseline|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467701|NCT00440700|P3|Participant Flow|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467702|NCT00440700|P2|Participant Flow|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467703|NCT00440700|P1|Participant Flow|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467704|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467705|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467706|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467707|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467708|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467709|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467710|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467711|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467712|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467713|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467714|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467715|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467716|NCT00440700|O3|Outcome|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467717|NCT00440700|O2|Outcome|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467718|NCT00440700|O1|Outcome|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467719|NCT00440700|E3|Reported Event|Usual Care|Patients receive usual care for the ICU and are encouraged to self-initiate rest periods twice daily.
467720|NCT00440700|E2|Reported Event|Headphones|Noise-canceling headphones only (no music) are applied by the patient to block out noise/sound in the ICU whenever desired.
467721|NCT00440700|E1|Reported Event|Patient-directed Music|Patients select preferred music for listening through headphones whenever they like for as long as they like whenever feeling anxious, desire some rest and quiet time, or for listening enjoyment while mechanically ventilated in the ICU.
467722|NCT00440557|B4|Baseline|Total|Total of all reporting groups
467723|NCT00440557|B3|Baseline|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467724|NCT00440557|B2|Baseline|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467725|NCT00440557|B1|Baseline|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467726|NCT00440557|P3|Participant Flow|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467727|NCT00440557|P2|Participant Flow|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467728|NCT00440557|P1|Participant Flow|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467729|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467730|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467731|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467732|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467733|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467734|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467735|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467736|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467737|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467738|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467739|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467740|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467741|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467742|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467743|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467744|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467745|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467746|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467747|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467748|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467749|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467750|NCT00440557|O3|Outcome|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467751|NCT00440557|O2|Outcome|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467752|NCT00440557|O1|Outcome|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467753|NCT00440557|E3|Reported Event|Epoetin Alfa:Once Every Two Weeks (Q2W)|Epoetin alfa once every 2 weeks for 44 weeks (initial subcutaneous dose 20,000 IU)
467754|NCT00440557|E2|Reported Event|Epoetin Alfa:Once Weekly (QW)|Epoetin alfa once weekly for 44 weeks (initial subcutaneous dose 10,000 IU)
467755|NCT00440557|E1|Reported Event|Epoetin Alfa:Three Injections Weekly (TIW)/Once Weekly (QW)|Epoetin alfa 3 times weekly for 22 weeks (initial subcutaneous (SC) dose 50 IU/kg), then once weekly, for 22 weeks (initial SC dose 10,000 IU)
467756|NCT00440531|B4|Baseline|Total|Total of all reporting groups
467757|NCT00440531|B3|Baseline|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467758|NCT00440531|B2|Baseline|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467759|NCT00440531|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467760|NCT00440531|P3|Participant Flow|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467761|NCT00440531|P2|Participant Flow|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467762|NCT00440531|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467763|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467764|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467765|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467766|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467767|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467768|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467769|NCT00440531|O3|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467770|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467771|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467772|NCT00440531|O1|Outcome|ENGERIX-B™|ENGERIX-B™, 20 µg (micrograms)
467773|NCT00440531|O2|Outcome|RECOMBIVAX-HB™|RECOMBIVAX-HB™, 10 µg (micrograms)
467774|NCT00440531|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 10 µg (micrograms)
467775|NCT00440518|B4|Baseline|Total|Total of all reporting groups
468731|NCT00437983|B1|Baseline|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
467776|NCT00440518|B3|Baseline|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467777|NCT00440518|B2|Baseline|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467778|NCT00440518|B1|Baseline|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467779|NCT00440518|P3|Participant Flow|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467780|NCT00440518|P2|Participant Flow|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467781|NCT00440518|P1|Participant Flow|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467782|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467783|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467784|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467785|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467786|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467787|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467788|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467789|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467790|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467791|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467792|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467793|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467794|NCT00440518|O3|Outcome|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467795|NCT00440518|O2|Outcome|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467796|NCT00440518|O1|Outcome|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467797|NCT00440518|E3|Reported Event|Lacosamide 300mg|Lacosamide 300mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467798|NCT00440518|E2|Reported Event|Lacosamide 100mg|Lacosamide 100mg immediate-release film coated tablet, oral administration twice daily 12 hours apart
467799|NCT00440518|E1|Reported Event|Placebo|Placebo immediate-release film coated tablet, oral administration twice daily 12 hours apart
467800|NCT00440505|B1|Baseline|Entire Study Population|
467801|NCT00440505|P6|Participant Flow|Nicotine 10 mg First, Then Placebo, Then Nicotine 5 mg|Nicotine 10 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
467802|NCT00440505|P5|Participant Flow|Nicotine 10 mg First, Then Nicotine 5 mg, Then Placebo|Nicotine 10 mg patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
467803|NCT00440505|P4|Participant Flow|Nicotine 5 mg First, Then Placebo, Then Nicotine 10 mg|Nicotine 5 mg patch for one day in first intervention period, placebo patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
467804|NCT00440505|P3|Participant Flow|Nicotine 5 mg First, Then Nicotine 10 mg, Then Placebo|Nicotine 5 mg patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and placebo patch for one day in the third intervention period.
467805|NCT00440505|P2|Participant Flow|Placebo First, Then Nicotine 10 mg, Then Nicotine 5 mg|Placebo patch for one day in first intervention period, nicotine 10 mg patch for one day in second intervention period and nicotine 5 mg patch for one day in the third intervention period.
467806|NCT00440505|P1|Participant Flow|Placebo First, Then Nicotine 5 mg, Then Nicotine 10 mg|Placebo patch for one day in first intervention period, nicotine 5 mg patch for one day in second intervention period and nicotine 10 mg patch for one day in the third intervention period.
467807|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467808|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467809|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
467810|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467811|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467812|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
467813|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467814|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467815|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
467816|NCT00440505|O3|Outcome|Nicotine 10 mg|Nicotine 10 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467817|NCT00440505|O2|Outcome|Nicotine 5 mg|Nicotine 5 mg patch administered for one day in either first intervention period, second intervention period or third intervention period.
467818|NCT00440505|O1|Outcome|Placebo|Placebo patch administered for one day in either first intervention period, second intervention period or third intervention period.
467819|NCT00440505|E3|Reported Event|Nicotine 10mg|Non-smokers with the Nicotine 10mg patch
467820|NCT00440505|E2|Reported Event|Nicotine 5mg|Non-smokers with the Nicotine 5mg patch
467821|NCT00440505|E1|Reported Event|Placebo|Non-smokers with the placebo patch
467822|NCT00440466|B4|Baseline|Total|Total of all reporting groups
467823|NCT00440466|B3|Baseline|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467824|NCT00440466|B2|Baseline|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467825|NCT00440466|B1|Baseline|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467826|NCT00440466|P3|Participant Flow|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467827|NCT00440466|P2|Participant Flow|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467828|NCT00440466|P1|Participant Flow|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467829|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467830|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467831|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467832|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467833|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467834|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467835|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467836|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467837|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467838|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467839|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467840|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467841|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467842|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467843|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467844|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467845|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467846|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467847|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467848|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467849|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467850|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467851|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467852|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467853|NCT00440466|O3|Outcome|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467854|NCT00440466|O2|Outcome|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467855|NCT00440466|O1|Outcome|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467856|NCT00440466|E3|Reported Event|Epoetin Alfa Q4W|Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk
467857|NCT00440466|E2|Reported Event|Epoetin Alfa Q2W|Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks
467858|NCT00440466|E1|Reported Event|Epoetin Alfa QW|Continue pre-study once weekly dose of epoetin alfa for 36 weeks
467859|NCT00440401|B3|Baseline|Total|Total of all reporting groups
467860|NCT00440401|B2|Baseline|Standard Treatment|
467861|NCT00440401|B1|Baseline|TachoSil®|
467862|NCT00440401|P2|Participant Flow|Comparator|Standard haemostatic treatment in cardiovascular surgery
467863|NCT00440401|P1|Participant Flow|TachoSil®|Absorbable sponge for intra-operative topical application
467864|NCT00440401|O2|Outcome|Standard Treatment|
467865|NCT00440401|O1|Outcome|TachoSil®|
467866|NCT00440401|O2|Outcome|Standard Treatment|
467867|NCT00440401|O1|Outcome|TachoSil®|
467868|NCT00440401|E2|Reported Event|Standard Treatment|
467869|NCT00440401|E1|Reported Event|TachoSil®|
467870|NCT00440310|B3|Baseline|Total|Total of all reporting groups
467871|NCT00440310|B2|Baseline|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467991|NCT00440050|P2|Participant Flow|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
467872|NCT00440310|B1|Baseline|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467873|NCT00440310|P2|Participant Flow|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467874|NCT00440310|P1|Participant Flow|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467875|NCT00440310|O2|Outcome|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467876|NCT00440310|O1|Outcome|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467877|NCT00440310|E2|Reported Event|Chemotherapy Alone|"FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467878|NCT00440310|E1|Reported Event|Litx + Chemotherapy|"Talaporfin sodium: LS11 (Talaporfin Sodium) dose is 1mg/kg administered intravenously slow push (3-5 minutes).~Percutaneous placement of device in liver metastases: Light Source placement will be conducted under placement imaging using ultrasound or CT guidance. No more than four Light Sources will be used at a single treatment session. The Light Sources may be used in a single lesion or in multiple lesions.~Interstitial light emitting diodes: 200 J/cm per Light Source at 20 mW/cm light energy~FOLFOX4 regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and oxaliplatin~FOLFIRI regimen: Standard care chemotherapy regimen consisting of leucovorin, 5-FU and irinotecan"
467879|NCT00440297|B3|Baseline|Total|Total of all reporting groups
467880|NCT00440297|B2|Baseline|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467881|NCT00440297|B1|Baseline|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467882|NCT00440297|P2|Participant Flow|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467883|NCT00440297|P1|Participant Flow|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467884|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467885|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467886|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467887|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467888|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467889|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467890|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467891|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467892|NCT00440297|O2|Outcome|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467893|NCT00440297|O1|Outcome|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467894|NCT00440297|E2|Reported Event|ENGERIX-B™|ENGERIX-B™, 2 x 20 µg(micrograms)
467895|NCT00440297|E1|Reported Event|Modified Process Hepatitis B Vaccine|Modified Process Hepatitis B Vaccine, 40 µg(micrograms)
467896|NCT00440271|B3|Baseline|Total|Total of all reporting groups
467897|NCT00440271|B2|Baseline|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467898|NCT00440271|B1|Baseline|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467899|NCT00440271|P2|Participant Flow|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467900|NCT00440271|P1|Participant Flow|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467992|NCT00440050|P1|Participant Flow|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
467901|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467902|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467903|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467904|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467905|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467906|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467907|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467908|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467909|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467910|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467911|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467912|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467913|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467914|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467915|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467916|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467917|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467918|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467919|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467920|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467921|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467922|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467923|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467924|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467925|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467926|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467927|NCT00440271|O2|Outcome|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467928|NCT00440271|O1|Outcome|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467929|NCT00440271|E2|Reported Event|Therapeutic Drug Monitoring (TDM)|Therapeutic Drug Monitoring (TDM) Arm = Patients began by receiving standard of care (SOC) tipranavir/ritonavir (TPV/r) capsules orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR) followed, if needed, by TPV or ritonavir (RTV) dose adjustments at Week 4, 6, 10, 14, 18, 22, 26 and 30 based on viral response, phenotypic inhibitory quotient (IQ), and TPV trough concentrations.
467930|NCT00440271|E1|Reported Event|Standard of Care (SoC)|Standard of Care (SOC) Arm = Tipranavir/ritonavir (TPV/r) capsules taken orally at a dose of 500 mg/200 mg twice a day (BID) plus optimized background regimen (OBR). No TPV/r dose changes were permitted.
467931|NCT00440232|B3|Baseline|Total|Total of all reporting groups
467932|NCT00440232|B2|Baseline|Placebo|
467933|NCT00440232|B1|Baseline|Frovatriptan|5.0 mg of Frovatriptan given as single dose
467934|NCT00440232|P2|Participant Flow|Placebo|
467935|NCT00440232|P1|Participant Flow|Frovatriptan|5.0 mg of Frovatriptan given as single dose
467936|NCT00440232|O2|Outcome|Placebo|
467937|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
467938|NCT00440232|O2|Outcome|Placebo|
467939|NCT00440232|O1|Outcome|Frovatriptan|5.0 mg of Frovatriptan given as single dose
467940|NCT00440232|E2|Reported Event|Placebo|
467941|NCT00440232|E1|Reported Event|Frovatriptan|5.0 mg of Frovatriptan given as single dose
467942|NCT00440193|B3|Baseline|Total|Total of all reporting groups
467943|NCT00440193|B2|Baseline|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467944|NCT00440193|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467945|NCT00440193|P2|Participant Flow|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467946|NCT00440193|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467947|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467948|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467949|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467950|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467951|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467952|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467993|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
467953|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467954|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467955|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467956|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467957|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467958|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467959|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467960|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467961|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467962|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467963|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467964|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467965|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467966|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467967|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467968|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467969|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467970|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467971|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467972|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467973|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467974|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467975|NCT00440193|O2|Outcome|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467976|NCT00440193|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467977|NCT00440193|E2|Reported Event|Enoxaparin/VKA|Participants were to receive 1.0 mg/kg enoxaparin twice daily (subcutaneous) for at least 5 days, plus vitamin K antagonist (VKA) (oral) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 to 3.0)
467978|NCT00440193|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 15 mg oral tablet twice daily for 3 weeks, followed by 20 mg once daily
467979|NCT00440180|B3|Baseline|Total|Total of all reporting groups
467980|NCT00440180|B2|Baseline|Anastrozole|1 milligram daily
467981|NCT00440180|B1|Baseline|Placebo|Placebo once daily
467982|NCT00440180|P2|Participant Flow|Anastrozole|1 milligram daily
467983|NCT00440180|P1|Participant Flow|Placebo|Placebo once daily
467984|NCT00440180|O2|Outcome|Anastrozole|1 milligram daily
467985|NCT00440180|O1|Outcome|Placebo|Placebo once daily
467986|NCT00440180|E2|Reported Event|Anastrozole|1 milligram daily
467987|NCT00440180|E1|Reported Event|Placebo|Placebo once daily
467988|NCT00440050|B3|Baseline|Total|Total of all reporting groups
467989|NCT00440050|B2|Baseline|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
467994|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
467995|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
467996|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
467997|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
467998|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
467999|NCT00440050|O2|Outcome|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
468000|NCT00440050|O1|Outcome|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
468001|NCT00440050|E2|Reported Event|Docosahexaenoic Acid (DHA)|Dosing of 2 grams of DHA administered in a divided dose twice daily with food.
468002|NCT00440050|E1|Reported Event|Placebo|Dosing of 2 grams of placebo administered in a divided dose twice daily with food.
468003|NCT00440011|B3|Baseline|Total|Total of all reporting groups
468004|NCT00440011|B2|Baseline|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
468005|NCT00440011|B1|Baseline|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
468006|NCT00440011|P2|Participant Flow|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
468007|NCT00440011|P1|Participant Flow|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
468008|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
468009|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
468010|NCT00440011|O2|Outcome|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
468011|NCT00440011|O1|Outcome|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
468012|NCT00440011|E2|Reported Event|Travoprost|travoprost 0.004% 1 drop nightly for 3 months
468013|NCT00440011|E1|Reported Event|Bimatoprost|bimatoprost 0.03% 1 drop nightly for 3 months
468014|NCT00439946|B1|Baseline|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468015|NCT00439946|P1|Participant Flow|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil initiated to deliver a dose 20% higher than the epoprostenol dose on a ng/kg/min basis. IV treprostinil dosing was titrated without restriction during the eight week follow-up period per the investigator's judgment to optimize the dose for symptomatic benefit based on clinical signs / symptoms, exercise capacity and tolerability.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468016|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468017|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468018|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468019|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468020|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468021|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468022|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468023|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468024|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468025|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468026|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468027|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468028|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468029|NCT00439946|O1|Outcome|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468030|NCT00439946|E1|Reported Event|Treprostinil|"All Subjects transitioned from IV epoprostenol to IV treprostinil.~treprostinil: rapid switch from intravenous epoprostenol on the CADD ambulatory pump to intravenous Remodulin on the Crono Five ambulatory pump"
468031|NCT00439777|B3|Baseline|Total|Total of all reporting groups
468121|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468032|NCT00439777|B2|Baseline|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468033|NCT00439777|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468034|NCT00439777|P2|Participant Flow|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468035|NCT00439777|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468036|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468037|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468038|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468039|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468040|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468041|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468042|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468043|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468044|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468045|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468046|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468047|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468048|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468049|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468050|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468051|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468052|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468053|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468054|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468055|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468056|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468057|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468058|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468059|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468060|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468061|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468062|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468063|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468064|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468065|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468066|NCT00439777|O2|Outcome|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468067|NCT00439777|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468068|NCT00439777|E2|Reported Event|Enoxaparin/VKA|Participants received enoxaparin (subcutaneous) 1.0 mg/kg b.i.d. for minimal 5 days, plus vitamin K antagonist (VKA) at individually titrated doses to achieve a target international normalized ratio (INR) of 2.5 (range: 2.0 - 3.0)
468069|NCT00439777|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants received 15 mg rivaroxaban (oral) twice daily (b.i.d.) for 3 weeks, followed by 20 mg once daily (o.d.)
468070|NCT00439738|B3|Baseline|Total|Total of all reporting groups
468071|NCT00439738|B2|Baseline|HCTZ +Amlodipine|
468072|NCT00439738|B1|Baseline|Valsartan/HCTZ (Hydrochlorothiazide)|
468073|NCT00439738|P2|Participant Flow|HCTZ +Amlodipine|
468074|NCT00439738|P1|Participant Flow|Valsartan/HCTZ (Hydrochlorothiazide)|
468075|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468076|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468077|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468078|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468079|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468080|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468081|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468082|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468083|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468084|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468085|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468086|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468087|NCT00439738|O2|Outcome|HCTZ +Amlodipine|
468088|NCT00439738|O1|Outcome|Valsartan/HCTZ (Hydrochlorothiazide)|
468089|NCT00439738|E2|Reported Event|HCTZ +Amlodipine|
468090|NCT00439738|E1|Reported Event|Valsartan/HCTZ (Hydrochlorothiazide)|
468091|NCT00439725|B3|Baseline|Total|Total of all reporting groups
468092|NCT00439725|B2|Baseline|Placebo|Participants were to receive matching placebo oral tablet once daily
468093|NCT00439725|B1|Baseline|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468094|NCT00439725|P2|Participant Flow|Placebo|Participants were to receive matching placebo oral tablet once daily
468095|NCT00439725|P1|Participant Flow|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468096|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468097|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468098|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468099|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468100|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468101|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468102|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468103|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468104|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468105|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468106|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468107|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468108|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468109|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468110|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468111|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468112|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468113|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468114|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468115|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468116|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468117|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468118|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468119|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468120|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468123|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468124|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468125|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468126|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468127|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468128|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468129|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468130|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468131|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468132|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468133|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468134|NCT00439725|O2|Outcome|Placebo|Participants were to receive matching placebo oral tablet once daily
468135|NCT00439725|O1|Outcome|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468136|NCT00439725|E2|Reported Event|Placebo|Participants were to receive matching placebo oral tablet once daily
468137|NCT00439725|E1|Reported Event|Rivaroxaban (Xarelto, BAY59-7939)|Participants were to receive rivaroxaban 20 mg oral tablet once daily
468138|NCT00439647|B3|Baseline|Total|Total of all reporting groups
468139|NCT00439647|B2|Baseline|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468140|NCT00439647|B1|Baseline|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468141|NCT00439647|P2|Participant Flow|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468142|NCT00439647|P1|Participant Flow|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468143|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468144|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468145|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468146|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468147|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468148|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468149|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468150|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468151|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468324|NCT00439244|B2|Baseline|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468152|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468153|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468154|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468155|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468156|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468157|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468158|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468159|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468160|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468161|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468162|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468163|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468164|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468165|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468166|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468167|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468168|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468169|NCT00439647|O2|Outcome|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468170|NCT00439647|O1|Outcome|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The intravenous (i.v.) infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year.
468171|NCT00439647|E2|Reported Event|Placebo|100 ml Placebo administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
468172|NCT00439647|E1|Reported Event|Zoledronic Acid|5 mg/100 ml administered via a peripheral intravenous site as a slow infusion over 15 minutes. The i.v. infusion was delivered via vented infusion line (to allow constant flow) and 20-22 gauge angiocatheter, and preceded and followed by a 10 ml normal saline flush of the intravenous line for a total volume infused of 120 ml once a year
468173|NCT00439608|B1|Baseline|Treatment|
468174|NCT00439608|P1|Participant Flow|Treatment|"Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer~Patients received cetuximab, 400 mg/mg2 over 2 h on Day 1 then 250 mg/m2/week over 1 h, for 5 additional weeks. Patients also received paclitaxel, 50 mg/m2/week, over 1 h and carboplatin AUC (area under the curve) = 2/week, over 30 min, for 6 weeks. Cetuximab was administered first. Patients were then monitored for 1 h. Paclitaxel was then administered followed by carboplatin. Radiation was generally administered after chemotherapy. Dexamethasone 20 mg intravenously (IV), diphenhydramine 50 mg IV, and ranitidine 50 mg IV were given 30 min before treatment. Dosages of dexamethasone and diphenhydramine could be reduced in subsequent weeks if no hypersensitivity reactions were observed."
468175|NCT00439608|O1|Outcome|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
468176|NCT00439608|E1|Reported Event|Treatment|Cetuximab, Paclitaxel, Carboplatin and Radiation for Esophageal, Gastroesophageal Junction and Gastric Cancer
468177|NCT00439569|B1|Baseline|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468178|NCT00439569|P1|Participant Flow|Subjects Enrolled|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1. Two new subjects were then enrolled in Cohort 2.
468179|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468180|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468181|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468182|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468183|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468184|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468185|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468186|NCT00439569|O1|Outcome|Subjects Enrolled (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first 3 subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM)approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of subjects (4 not completed), more than 3 subjects were enrolled in Cohort 1.
468187|NCT00439569|E1|Reported Event|Cohorts 1 & 2 (500 mg/kg/Day)|Cohort 1 was assigned a dosage of 500 mg/kg/day. One subject was replaced due to an allergic reaction and four subjects due to less than 80 percent study drug compliance. Due to these replacements, more than 3 subjects were enrolled in the first cohort. Cohort 2 was assigned a dosage of 500 mg/kg/day by the MCRM and approved by the SMC due to dose-limiting toxicities experienced in Cohort 1. For the purpose of reporting adverse events, these two cohorts were combined for a total of 9 enrolled subjects.
468188|NCT00439517|B3|Baseline|Total|Total of all reporting groups
468189|NCT00439517|B2|Baseline|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468190|NCT00439517|B1|Baseline|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468191|NCT00439517|P2|Participant Flow|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468192|NCT00439517|P1|Participant Flow|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468193|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468194|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468195|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468196|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468197|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468198|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468199|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468200|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468201|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468202|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468203|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468204|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468205|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468206|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468207|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468208|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468209|NCT00439517|O2|Outcome|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468210|NCT00439517|O1|Outcome|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468211|NCT00439517|E2|Reported Event|FOLFOX4 + Cetuximab|"FOLFOX4 is a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85 mg/m^2) on days 1 and 15 (every 2 weeks)~5-FU bolus + infusions (400 mg/m^2) on days 1, 2, 15 and 16~Folinic Acid infusions (200 mg/m^2) on days 1, 2, 15 and 16"
468212|NCT00439517|E1|Reported Event|UFOX + Cetuximab|"UFOX is a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin and Folinic Acid.~Cetuximab infusion (400 mg/m^2 on day 1 of cycle 1 and 250 mg/m^2 at each subsequent day 1, as well as on days 8, 15 and 22)~Oxaliplatin infusion (85mg/m^2) on days 1 and 15 (every 2 weeks)~Oral UFT® (250mg/m^2 tegafur + 560 mg/m^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21~Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21"
468213|NCT00439413|B3|Baseline|Total|Total of all reporting groups
468214|NCT00439413|B2|Baseline|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
468215|NCT00439413|B1|Baseline|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
468216|NCT00439413|P2|Participant Flow|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
468217|NCT00439413|P1|Participant Flow|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
468218|NCT00439413|O2|Outcome|Placebo|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm placebo patch applied daily for 10 weeks
468219|NCT00439413|O1|Outcome|Selegiline Transdermal System|Participants received Selegiline Transdermal System (STS) 20 mg x 20 cm patch applied daily for 10 weeks
468220|NCT00439413|O2|Outcome|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
468221|NCT00439413|O1|Outcome|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
468256|NCT00439335|E1|Reported Event|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468257|NCT00439309|B3|Baseline|Total|Total of all reporting groups
468222|NCT00439413|E2|Reported Event|Matching Placebo|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System placebo patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
468223|NCT00439413|E1|Reported Event|Selegiline Transdermal System|"Subjects were evaluated for their compliance with protocol inclusion/exclusion criteria during -2 to -1 week Screening/Baseline Phase.~During treatment, subjects received 20mg x 20cm Selegiline Transdermal System patch, once daily for 10 weeks.~Subjects were provided on-site brief counseling sessions 1x per week for 9 weeks."
468224|NCT00439335|B3|Baseline|Total|Total of all reporting groups
468225|NCT00439335|B2|Baseline|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468226|NCT00439335|B1|Baseline|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468227|NCT00439335|P2|Participant Flow|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468228|NCT00439335|P1|Participant Flow|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468229|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468230|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468231|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468232|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468233|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468234|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468235|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468236|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468237|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468238|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468239|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468240|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468241|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468242|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468243|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468244|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468245|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468246|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468247|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468248|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468249|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468250|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468251|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468252|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468253|NCT00439335|O2|Outcome|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468254|NCT00439335|O1|Outcome|H5 HA ID|Vaccine group H5 HA ID: the subject will receive 0.1 mL of H5 HA by the ID route in one arm and 0.1 mL of saline placebo by the IM route in the other arm.
468255|NCT00439335|E2|Reported Event|H5 HA IM|Vaccine group H5 HA IM: the subject will receive 0.1 mL of H5 HA by the IM route in one arm and 0.1 mL of saline placebo by the ID route in the other arm.
468393|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468258|NCT00439309|B2|Baseline|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468259|NCT00439309|B1|Baseline|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468260|NCT00439309|P2|Participant Flow|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468261|NCT00439309|P1|Participant Flow|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468262|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468263|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468264|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468265|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468266|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468267|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468268|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468269|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468270|NCT00439309|O2|Outcome|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468271|NCT00439309|O1|Outcome|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468296|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468272|NCT00439309|E2|Reported Event|GELFOAM/THROMBIN|GELFOAM/THROMBIN description - GELFOAM Sterile Compressed Sponge is a medical device intended for application to bleeding surfaces as a hemostatic. It is water-insoluble, off-white, nonelastic, porous, pliable product prepared from purified porcine Skin Gelatin USP Granulates and Water for Injection, USP. It may be cut without fraying and is able to absorb and hold within its interstices, many times its weight of blood and other fluids. Although not necessary, GELFOAM can be used either with or without thrombin to obtain hemostasis.
468273|NCT00439309|E1|Reported Event|VascuSeal|Consists of two liquids that when mixed together in situ rapidly cross-link to form a biocompatible absorbable sealant that is tissue adherent. These liquids are sprayed onto tissues using the Dual Liquid Applicator. The formed Sealant remains intact for approximately 2 to 7 days. During this period the Sealant undergoes hydrolysis where it is absorbed into the circulatory system and is excreted through the kidneys.
468274|NCT00439270|B6|Baseline|Total|Total of all reporting groups
468275|NCT00439270|B5|Baseline|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468276|NCT00439270|B4|Baseline|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468277|NCT00439270|B3|Baseline|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468278|NCT00439270|B2|Baseline|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468279|NCT00439270|B1|Baseline|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468280|NCT00439270|P5|Participant Flow|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468281|NCT00439270|P4|Participant Flow|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468282|NCT00439270|P3|Participant Flow|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468283|NCT00439270|P2|Participant Flow|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468284|NCT00439270|P1|Participant Flow|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
468285|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468286|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468287|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468288|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468289|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468290|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468291|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468292|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468293|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468294|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468295|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468297|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468298|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468299|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468300|NCT00439270|O5|Outcome|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468301|NCT00439270|O4|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468302|NCT00439270|O3|Outcome|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468303|NCT00439270|O2|Outcome|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468304|NCT00439270|O1|Outcome|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2. Provided no dose-limiting toxicities occurred, at least 3 participants received treatment in each arm.
468305|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468306|NCT00439270|O1|Outcome|All Treated|Participants received dasatinib, 50, 70, 100, or 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 or 75 mg/m^2.
468307|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2 (Phase 2 )|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468308|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468309|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468310|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If, for a dose level combination, 2 or more DLTs were observed, the maximum tolerated dose was defined as the previous dose level combination.
468311|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468312|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468313|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468314|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468315|NCT00439270|O1|Outcome|All Treated (Phase 1)|Participants received dasatinib as 50, 70, 100, or 120 mg administered orally once daily with docetaxel, administered every 3 weeks as an infusion at 60 or 75 mg/m^2. A standard 3+3 design was used, in which 3-6 patients were exposed to a dose level combination. Using a dose escalation scheme, the first 3-6 patients received the lower dose level combination. Escalation to the next dose level combination for another set of 3-6 patients was initiated if no dose-limiting toxicities (DLTs) were observed. If 2 or more DLTs were observed for a dose level combination, the MTD was defined as the previous dose level combination.
468316|NCT00439270|O1|Outcome|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468317|NCT00439270|E5|Reported Event|Dasatinib, 70 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 70 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468318|NCT00439270|E4|Reported Event|Dasatinib, 50 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 50 mg administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468319|NCT00439270|E3|Reported Event|Dasatinib, 50 mg + Docetaxel, 60 mg/m^2|Participants received dasatinib, 50 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 60 mg/m^2.
468320|NCT00439270|E2|Reported Event|Dasatinib, 120 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 120 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468321|NCT00439270|E1|Reported Event|Dasatinib, 100 mg + Docetaxel, 75 mg/m^2|Participants received dasatinib, 100 mg, administered orally once daily. Docetaxel was administered every 3 weeks as an infusion at 75 mg/m^2.
468322|NCT00439244|B4|Baseline|Total|Total of all reporting groups
468323|NCT00439244|B3|Baseline|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468325|NCT00439244|B1|Baseline|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468326|NCT00439244|P3|Participant Flow|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468327|NCT00439244|P2|Participant Flow|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468328|NCT00439244|P1|Participant Flow|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468329|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468330|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468331|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468332|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468333|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468334|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468335|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468336|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468337|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468338|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468339|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468340|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468341|NCT00439244|O3|Outcome|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468342|NCT00439244|O2|Outcome|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468479|NCT00438750|B2|Baseline|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468343|NCT00439244|O1|Outcome|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468344|NCT00439244|E3|Reported Event|Placebo Zoledronic Acid Plus Teriparatide|Placebo zoledronic acid 100 mL intravenous (i.v.) (once at randomization) plus teriparatide 20 μg (daily subcutaneous injections administered concurrently through 52 weeks). Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468345|NCT00439244|E2|Reported Event|Zoledronic Acid Plus Teriparatide|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion. Teriparatide is supplied as sterile, colorless clear, isotonic solution in a glass cartridge which is pre-assembled into a disposable pen device for subcutaneous injection. The pen device delivers 20 μg of teriparatide concurrently as daily subcutaneous injections for 52 weeks.
468346|NCT00439244|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5.0 mg/100 mL was administered via a peripheral intravenous site at Visit 2 (once at randomization) as a slow 15-minute infusion.
468347|NCT00439231|B1|Baseline|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic leukemia (SLL) using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
468348|NCT00439231|P1|Participant Flow|CLL Subjects Response to Lenalidomide (Revlimid)|To establish a response rate to lenalidomide (Revlimid) in subjects with CLL/SLL using a 3 week on, 3 week off dosing regimen. The responses will be categorized using the revised 1996 National Cancer Institute - sponsored working guidelines. The response rate will be based on changes in peripheral blood measures (ANC, platelets and/or hemoglobin), lymphadenopathy, hepatomegaly, splenomegaly or constitutional symptoms; and bone marrow biopsy measured at 24 weeks after the first dose of lenalidomide using the protocol dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
468349|NCT00439231|O1|Outcome|CLL Subject Response Rate After Lenalidomide Therapy|To establish a response rate to lenalidomide (Revlimid) in subjects with chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) using a 3 week on, 3 week off dosing regimen. Complete responders will respond to treatment after 2 cycles. Partial responders will respond to treatment after 4 cycles.
468350|NCT00439231|E1|Reported Event|CLL Subjects Treated With Lenalidomide (Revlimid)|
468351|NCT00439218|B1|Baseline|Subject Enrollments (Cohort 1, Cohort 2)|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468352|NCT00439218|P1|Participant Flow|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468353|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468354|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468355|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468356|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468357|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468358|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468359|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468360|NCT00439218|O1|Outcome|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468361|NCT00439218|E1|Reported Event|Subject Enrollments|Cohorts of 3 subjects were to be enrolled sequentially in escalating dosage levels. The first three subjects enrolled at 500 mg/kg/day for the duration of the study drug period. The next cohort's dosage was determined by the Modified Continual Re-assessment Method (MCRM) approach and approval of the Study Monitoring Committee (SMC). The MCRM calculation could indicate that additional subjects should be enrolled at the same dosage or a higher dosage. Due to the replacement of a subject (1 not completed), more than 3 subjects were enrolled in cohort 1. One new subject was enrolled in Cohort 2.
468362|NCT00439179|B5|Baseline|Total|Total of all reporting groups
468363|NCT00439179|B4|Baseline|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
468364|NCT00439179|B3|Baseline|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
468365|NCT00439179|B2|Baseline|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
468366|NCT00439179|B1|Baseline|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
468367|NCT00439179|P4|Participant Flow|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day.(combination)
468368|NCT00439179|P3|Participant Flow|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day. (combination)
468369|NCT00439179|P2|Participant Flow|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day. (combination)
468370|NCT00439179|P1|Participant Flow|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day. (combination)
468371|NCT00439179|O4|Outcome|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
468372|NCT00439179|O3|Outcome|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
468373|NCT00439179|O2|Outcome|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
468374|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
468375|NCT00439179|O4|Outcome|Cohort 4|GEMOX+ GW572016 1500mg/day
468376|NCT00439179|O3|Outcome|Cohort 3|GEMOX+ GW572016 1000mg day
468377|NCT00439179|O2|Outcome|Cohort 2|weekly gem+ GW572016, 1500mg/day
468378|NCT00439179|O1|Outcome|Cohorts 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
468379|NCT00439179|E4|Reported Event|Cohort 4|Cohort 4: GEMOX + GW572016 1500 mg/day
468380|NCT00439179|E3|Reported Event|Cohort 3|Cohort 3: GEMOX + GW572016 1000 mg/day.
468381|NCT00439179|E2|Reported Event|Cohort 2|Cohort 2: Weekly gem + GW572016, 1500 mg/day.
468382|NCT00439179|E1|Reported Event|Cohort 1|Cohort 1: Weekly gem + GW572016, 1000mg/day.
468383|NCT00439140|B4|Baseline|Total|Total of all reporting groups
468384|NCT00439140|B3|Baseline|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
468385|NCT00439140|B2|Baseline|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468386|NCT00439140|B1|Baseline|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468387|NCT00439140|P3|Participant Flow|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1. (If applicable after 12 weeks, participants received either botulinum toxin Type A 200U or 300U in Treatment Cycle 2.)
468388|NCT00439140|P2|Participant Flow|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468389|NCT00439140|P1|Participant Flow|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468390|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468391|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468392|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468394|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468395|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468396|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468397|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468398|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468399|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468400|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468401|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468402|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468403|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468404|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468405|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468406|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468407|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468408|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468409|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468410|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468411|NCT00439140|O3|Outcome|Placebo|Placebo (Normal Saline) injection into the detrusor on Day 1.
468412|NCT00439140|O2|Outcome|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468413|NCT00439140|O1|Outcome|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468414|NCT00439140|E3|Reported Event|Placebo/Botulinum Toxin Type A|Placebo (Normal Saline) injection into the detrusor on Day 1 followed by a botulinum toxin Type A 200U or 300U injection after a minimum of 12 weeks (if applicable).
468415|NCT00439140|E2|Reported Event|Botulinum Toxin Type A 300U|Botulinum toxin Type A 300U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 300U injection after a minimum of 12 weeks (if applicable).
468416|NCT00439140|E1|Reported Event|Botulinum Toxin Type A 200U|Botulinum toxin Type A 200U injection into the detrusor on Day 1 followed by a repeat botulinum toxin Type A 200U injection after a minimum of 12 weeks (if applicable).
468417|NCT00438971|B1|Baseline|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468418|NCT00438971|P1|Participant Flow|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468419|NCT00438971|O1|Outcome|Duloxetine|
468420|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468421|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468422|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468423|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468424|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468732|NCT00437983|P2|Participant Flow|Placebo|Cellulose tainted with fishy odor
468425|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468426|NCT00438971|O1|Outcome|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468427|NCT00438971|E1|Reported Event|Duloxetine|Duloxetine was initiated at 30 mg/day at the baseline visit, flexibly increased to 60 mg/day after 1 week, then flexibly titrated up to a maximum of 120 mg/day over the next 4 weeks based on response and tolerability with a minimum dose of 60 mg by week 4 required in order for the patient to remain in the study.
468428|NCT00438932|B5|Baseline|Total|Total of all reporting groups
468429|NCT00438932|B4|Baseline|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468430|NCT00438932|B3|Baseline|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
468431|NCT00438932|B2|Baseline|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468432|NCT00438932|B1|Baseline|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
468433|NCT00438932|P4|Participant Flow|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468434|NCT00438932|P3|Participant Flow|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
468435|NCT00438932|P2|Participant Flow|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468436|NCT00438932|P1|Participant Flow|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
468437|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468438|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
468439|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468440|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
468441|NCT00438932|O4|Outcome|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468442|NCT00438932|O3|Outcome|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
468443|NCT00438932|O2|Outcome|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468444|NCT00438932|O1|Outcome|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
468445|NCT00438932|E4|Reported Event|Placebo & Unrestricted Phosphorous Diet|Placebo and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468446|NCT00438932|E3|Reported Event|Placebo & Low Phosphorous Diet|Placebo and low phosphorus diet consisting of 800 mg of phosphorus per day.
468447|NCT00438932|E2|Reported Event|Lanthanum Carbonate & Unrestricted Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and unrestricted diet containing 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg.
468448|NCT00438932|E1|Reported Event|Lanthanum Carbonate & Low Phosphorous Diet|Lanthanum carbonate 1000mg 3x/day and low phosphorus diet of 800 mg of phosphorus per day.
468449|NCT00438880|B3|Baseline|Total|Total of all reporting groups
468450|NCT00438880|B2|Baseline|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468451|NCT00438880|B1|Baseline|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468452|NCT00438880|P2|Participant Flow|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468453|NCT00438880|P1|Participant Flow|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468454|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468455|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468456|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468457|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468458|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468459|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468460|NCT00438880|O2|Outcome|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468461|NCT00438880|O1|Outcome|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468462|NCT00438880|E2|Reported Event|Phase II|"Phase II patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~0.48 mg/kg CpG 7909 (Agatolimod Sodium) doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468463|NCT00438880|E1|Reported Event|Phase I|"Phase I patients will receive the following treatment:~250 mg/m^2 Rituximab IV on days 1, 8, and 15 of a 27 day cycle~5 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 1~10 mCi (Indium-111), 1.6 mg Ibritumomab IV on day 8~CpG 7909 (Agatolimod Sodium) doses will be assigned in groups of 6 patients. Dose levels will escalate in each group until maximum tolerability is attained (starting at 0.08 mg/kg and sequentially escalating to 0.16 mg/kg, 0.32 mg/kg, 0.48 mg/kg). Doses will be taken day 6, 13, 20, and 27 of a 27 day cycle.~0.4 mCi/kg Yttrium-90 Zevalin IV on day 15"
468464|NCT00438854|B1|Baseline|Group 1|
468465|NCT00438854|P1|Participant Flow|Group 1|
468466|NCT00438854|O1|Outcome|Dasatinib|Treatment arm/dasatinib pill
468467|NCT00438854|E1|Reported Event|Group 1|
468468|NCT00438815|B1|Baseline|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468469|NCT00438815|P1|Participant Flow|Open-label C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468470|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468471|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468472|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468473|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468474|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468475|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468476|NCT00438815|O1|Outcome|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468477|NCT00438815|E1|Reported Event|Open-label C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
468478|NCT00438750|B3|Baseline|Total|Total of all reporting groups
468733|NCT00437983|P1|Participant Flow|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
468480|NCT00438750|B1|Baseline|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468481|NCT00438750|P2|Participant Flow|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468482|NCT00438750|P1|Participant Flow|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468483|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468484|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468485|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468486|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468487|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468488|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468489|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468490|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468491|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468492|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468493|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468494|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468495|NCT00438750|O2|Outcome|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468496|NCT00438750|O1|Outcome|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468497|NCT00438750|E2|Reported Event|Occupational Therapy Cohort|Subjects who follow the conventional protocol of seeing a therapist to learn and guide them in their exercises.
468498|NCT00438750|E1|Reported Event|Independent Exercise Cohort|Subjects who learn their therapy exercises from the surgeon and practice them independently at home.
468499|NCT00438672|B3|Baseline|Total|Total of all reporting groups
468500|NCT00438672|B2|Baseline|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
468501|NCT00438672|B1|Baseline|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
468502|NCT00438672|P2|Participant Flow|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
468503|NCT00438672|P1|Participant Flow|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
468504|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
468505|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
468506|NCT00438672|O2|Outcome|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
468507|NCT00438672|O1|Outcome|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
468508|NCT00438672|E2|Reported Event|Placebo (Lidocaine Only) Cohort|Single injection of 2 mL 1% lidocaine
468509|NCT00438672|E1|Reported Event|Dexamethasone Cohort|Single injection of 1 mL dexamethasone mixed with 1 mL 1% lidocaine without epinephrine
468510|NCT00438659|B3|Baseline|Total|Total of all reporting groups
468511|NCT00438659|B2|Baseline|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
468512|NCT00438659|B1|Baseline|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468513|NCT00438659|P2|Participant Flow|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468514|NCT00438659|P1|Participant Flow|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468515|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
468516|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468517|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468518|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468519|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
468520|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468521|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
468522|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468523|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468524|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468525|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468526|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468527|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468528|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468529|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468530|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468531|NCT00438659|O2|Outcome|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm A.
468532|NCT00438659|O1|Outcome|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468533|NCT00438659|E2|Reported Event|Placebo|Patients apply 2.5 mL of an identical-appearing placebo cream to the treatment area as in arm B.
468534|NCT00438659|E1|Reported Event|Mometasone|Patients apply 2.5 mL mometasone furoate cream once daily to the treatment area (breast or chest wall) for the duration of planned radiotherapy.
468535|NCT00436748|B3|Baseline|Total|Total of all reporting groups
468536|NCT00436748|B2|Baseline|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468537|NCT00436748|B1|Baseline|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468538|NCT00436748|P2|Participant Flow|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468539|NCT00436748|P1|Participant Flow|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468540|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468541|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468542|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468543|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468544|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468545|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468584|NCT00438464|P2|Participant Flow|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468585|NCT00438464|P1|Participant Flow|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468586|NCT00438464|O2|Outcome|Within GG4, Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
468546|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468547|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468548|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468549|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468550|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468551|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468552|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468553|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468554|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468555|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468556|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468557|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468558|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468559|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468587|NCT00438464|O1|Outcome|Within GG3, Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
468734|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
468560|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468561|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468562|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468563|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468564|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468565|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468566|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468567|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468568|NCT00436748|O2|Outcome|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468569|NCT00436748|O1|Outcome|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468570|NCT00436748|E2|Reported Event|Darbepoetin Alfa Q2W|Participants received darbepoetin alfa every 2 weeks (Q2W) and a placebo every other 2 weeks to maintain the blind for 24 weeks. The initial dose was 0.75 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468571|NCT00436748|E1|Reported Event|Darbepoetin Alfa QW|Participants received darbepoetin alfa once a week (QW) for 24 weeks. The initial dose was 0.45 μg/kg; thereafter, active doses were administered to achieve and then maintain hemoglobin levels within a target range of 10.0 to 12.0 g/dL. Participants not on dialysis or who were receiving peritoneal dialysis were administered darbepoetin alfa subcutaneously; participants receiving hemodialysis were administered darbepoetin alfa intravenously.
468572|NCT00438490|B3|Baseline|Total|Total of all reporting groups
468573|NCT00438490|B2|Baseline|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
468574|NCT00438490|B1|Baseline|Placebo|
468575|NCT00438490|P2|Participant Flow|Recombinant Human Prolactin|Recombinant Human Prolactin 60 mcg/kg once daily
468576|NCT00438490|P1|Participant Flow|Placebo|Normal Saline Placebo once daily
468577|NCT00438490|O2|Outcome|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
468578|NCT00438490|O1|Outcome|Placebo|
468579|NCT00438490|E2|Reported Event|Recombinant Human Prolactin|"RhProlactin once daily~Recombinant Human Prolactin :"
468580|NCT00438490|E1|Reported Event|Placebo|
468581|NCT00438464|B3|Baseline|Total|Total of all reporting groups
468582|NCT00438464|B2|Baseline|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468583|NCT00438464|B1|Baseline|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468588|NCT00438464|O2|Outcome|Within GG4, Finasteride Arm|Participants with GG4 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
468589|NCT00438464|O1|Outcome|Within GG3, Finasteride Arm|Participants with GG3 score in Finasteride Arm, receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
468590|NCT00438464|O2|Outcome|GG4, Within Placebo Arm|Participants with GG4 score in Plaebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
468591|NCT00438464|O1|Outcome|GG3, Within Placebo Arm|Participants with GG3 score in Placebo Arm, receiving placebo daily for 4-6 weeks, then receive prostatectomy.
468592|NCT00438464|O2|Outcome|GG4, Within Finasteride Arm|Participants with GG4 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
468593|NCT00438464|O1|Outcome|GG3, Within Finasteride Arm|Participants with GG3 score receiving 5 mg daily for 4-6 weeks, then receive prostatectomy.
468594|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468595|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468596|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468597|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468598|NCT00438464|O2|Outcome|Placebo Arm Within GG4|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468599|NCT00438464|O1|Outcome|Finasteride Arm Within GG4|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468600|NCT00438464|O2|Outcome|Placebo Arm Within GG3|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468601|NCT00438464|O1|Outcome|Finasteride Arm Within GG3|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468602|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468603|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468604|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468605|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468606|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468607|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468608|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468609|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468610|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468611|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468612|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468613|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468614|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468615|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468616|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468617|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468618|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468619|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468620|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468621|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468622|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468623|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468624|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468625|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468626|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468627|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468628|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468629|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468630|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468631|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468632|NCT00438464|O2|Outcome|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468633|NCT00438464|O1|Outcome|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468634|NCT00438464|E2|Reported Event|Arm II (Placebo)|Placebo once daily for 4-6 weeks, then undergo prostatectomy.
468635|NCT00438464|E1|Reported Event|Arm I (Finasteride)|Finasteride 5 mg once daily for 4-6 weeks, then undergo prostatectomy.
468636|NCT00438451|B4|Baseline|Total|Total of all reporting groups
468637|NCT00438451|B3|Baseline|Lamotrigine|Lamotrigine 25mg
468638|NCT00438451|B2|Baseline|Carbamazepine|Carbamazepine 100mg
468639|NCT00438451|B1|Baseline|Levetiracetam|Levetiracetam 250mg
468699|NCT00438360|B3|Baseline|Total|Total of all reporting groups
468700|NCT00438360|B2|Baseline|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468701|NCT00438360|B1|Baseline|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468640|NCT00438451|P3|Participant Flow|Lamotrigine|Lamotrigine 25mg: capsules, each containing one Lamotrigine 25mg tablet. During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed.
468641|NCT00438451|P2|Participant Flow|Carbamazepine|"Carbamazepine 100mg: capsules, each containing half of one Carbamazepine 200mg slow release tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
468642|NCT00438451|P1|Participant Flow|Levetiracetam|"Levetiracetam 250mg: capsules, each containing one Levetiracetam 250mg film-coated tablet.~During titration phase, subjects received 1 capsule in the evening in the first 14 days, 2 capsules (1 in the morning and 1 in the evening) in week 3 and 4, 3 capsules in week 5 (1 in the morning and 2 in the evening) and 4 capsules from week 6 onwards (2 in the morning and 2 in the evening). During maintenance phase, dose adjustments could be made according to tolerability and seizure control in steps of 1 capsule per week. Dosages between 2 to 12 capsules per day were allowed."
468643|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468644|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468645|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468646|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468647|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468648|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468649|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468650|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468651|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468652|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468653|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468654|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468655|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468656|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468657|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468658|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468659|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468660|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468661|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468662|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468663|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468664|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468665|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468666|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468667|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468668|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468669|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468670|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468671|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468672|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468673|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468674|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468675|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468676|NCT00438451|O3|Outcome|Lamotrigine|Lamotrigine 25mg
468677|NCT00438451|O2|Outcome|Carbamazepine|Carbamazepine 100mg
468678|NCT00438451|O1|Outcome|Levetiracetam|Levetiracetam 250mg
468679|NCT00438451|E3|Reported Event|Lamotrigine|Lamotrigine 25mg
468680|NCT00438451|E2|Reported Event|Carbamazepine|Carbamazepine 100mg
468681|NCT00438451|E1|Reported Event|Levetiracetam|Levetiracetam 250mg
468682|NCT00438399|B4|Baseline|Total|Total of all reporting groups
468683|NCT00438399|B3|Baseline|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
468684|NCT00438399|B2|Baseline|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
468685|NCT00438399|B1|Baseline|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
468686|NCT00438399|P6|Participant Flow|Corticosteroid 3-Wash Out-C. Propionate|Corticosteroid 3 first, then Clobetasol propionate
468687|NCT00438399|P5|Participant Flow|C. Propionate -Wash Out-Corticosteroid 3|Clobetasol propionate shampoo first then Corticosteroid 3
468688|NCT00438399|P4|Participant Flow|Corticosteroid 2-Wash Out-C. Propionate|Corticosteroid 2 first, then Clobetasol propionate shampoo
468689|NCT00438399|P3|Participant Flow|C. Propionate-Wash Out-Corticosteroid 2|Clobetasol propionate Shampoo first, then Corticosteroid 2
468690|NCT00438399|P2|Participant Flow|Corticosteroid 1-Wash Out-C. Propionate|Corticosteroid 1 first then Clobetasol propionate Shampoo
468691|NCT00438399|P1|Participant Flow|C. Propionate-Wash Out-Corticosteroid 1|Clobetasol propionate Shampoo first, then Corticosteroid 1
468692|NCT00438399|O3|Outcome|C. Propionate Compared to Corticosteroid 3|C. propionate shampoo: once daily Corticosteroid 3 scalp application: twice daily
468693|NCT00438399|O2|Outcome|C. Propionate Compared to Corticosteroid 2|C. propionate shampoo: once daily Corticosteroid 2 lotion: twice daily
468694|NCT00438399|O1|Outcome|C. Propionate Compared to Corticosteroid 1|C. propionate shampoo: once daily Corticosteroid 1 foam:twice daily
468695|NCT00438399|E4|Reported Event|Clobetasol Propionate Shampoo|All subjects having used Clobetasol propionate shampoo
468696|NCT00438399|E3|Reported Event|Corticosteroid 3|All subjects having used Corticosteroid 3
468697|NCT00438399|E2|Reported Event|Corticosteroid 2|All subjects having used Corticosteroid 2
468698|NCT00438399|E1|Reported Event|Corticosteroid 1|All subjects having used Corticosteroid 1
468702|NCT00438360|P2|Participant Flow|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468703|NCT00438360|P1|Participant Flow|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468704|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468705|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468706|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468707|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468708|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468709|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468710|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468711|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468712|NCT00438360|O2|Outcome|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468713|NCT00438360|O1|Outcome|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468714|NCT00438360|E2|Reported Event|Placebo|Oral soft gelatin capsules of placebo matching cyclosporine administered twice a week for 24 weeks in two daily administrations.
468715|NCT00438360|E1|Reported Event|Cyclosporine A|Oral soft gelatin capsules of cyclosporine 10 mg, 25 mg, 50 mg or 100 mg administered twice a week for 24 weeks at the dosage of 5 mg/Kg/day in two daily administrations.
468716|NCT00438204|B1|Baseline|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
468717|NCT00438204|P1|Participant Flow|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
468718|NCT00438204|O1|Outcome|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
468719|NCT00438204|E1|Reported Event|Bevacizumab, Gemcitabine Hydrochloride|"Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days.~bevacizumab: Bevacizumab 10mg/kg IV over 90 ± 15 minutes every 14 days~gemcitabine hydrochloride: Gemcitabine 1200 mg/m2 intravenously over 30 minutes following the pemetrexed every 14 days~pemetrexed disodium: Pemetrexed 400 mg/m2 intravenously over 10 minutes every 14 days."
468720|NCT00438100|B3|Baseline|Total|Total of all reporting groups
468721|NCT00438100|B2|Baseline|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
468722|NCT00438100|B1|Baseline|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
468723|NCT00438100|P2|Participant Flow|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
468724|NCT00438100|P1|Participant Flow|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
468725|NCT00438100|O2|Outcome|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
468726|NCT00438100|O1|Outcome|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
468727|NCT00438100|E2|Reported Event|S-1 Arm|"S-1: 80 mg/m2 orally bid daily for day 1 through day28 followed by 14-day washout; repeat this as a course.~S-1: 80 mg/m2 orally bid daily for day 1 through day 28 followed by 14-day washout; repeat this as a course."
468728|NCT00438100|E1|Reported Event|Capecitabine Arm|"Capecitabine (Xeloda): 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course.~Capecitabine: 1600 mg/m2 orally bid daily for day 1 through day 21 followed by 7-day washout; repeat this as a course."
468735|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
468736|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
468737|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
468738|NCT00437983|O2|Outcome|Placebo|Cellulose tainted with fishy odor
468739|NCT00437983|O1|Outcome|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
468740|NCT00437983|E2|Reported Event|Placebo|Cellulose tainted with fishy odor
468741|NCT00437983|E1|Reported Event|PS-Omega3|Phosphatidylserine-Omega3, 300mg/day 15 wk
468742|NCT00437645|B3|Baseline|Total|Total of all reporting groups
468743|NCT00437645|B2|Baseline|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468744|NCT00437645|B1|Baseline|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468745|NCT00437645|P2|Participant Flow|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468746|NCT00437645|P1|Participant Flow|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468747|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468748|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468749|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468750|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468751|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468752|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468778|NCT00437398|E1|Reported Event|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
468779|NCT00437281|B21|Baseline|Total|Total of all reporting groups
469336|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
468753|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468754|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468755|NCT00437645|O2|Outcome|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468756|NCT00437645|O1|Outcome|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468757|NCT00437645|E2|Reported Event|Amlodipine 10 mg|Eight (8) weeks of treatment with amlodipine 10 mg (two 5 mg capsules). Together with the active medication, the patients received a placebo that matched valsartan 160 mg. At Week 8, patients were switched and treated with the combination of valsartan/amlodipine 160/5 mg and a placebo that matched amlodipine 5 mg for an additional 4 weeks until the end of the study. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468758|NCT00437645|E1|Reported Event|Valsartan/Amlodipine 160/5 mg|Twelve (12) weeks treatment with the combination of valsartan/amlodipine 160/5 mg. Together with the active medication, patients received a placebo that matched amlodipine 5 mg. The three capsules were taken by mouth with water once daily in the morning, regardless of meals. Patients were instructed not to take their study medication the morning of their study visits. Instead, they brought the study medication with them to the site and took it there as instructed by the investigator.
468759|NCT00437489|B3|Baseline|Total|Total of all reporting groups
468760|NCT00437489|B2|Baseline|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468761|NCT00437489|B1|Baseline|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468762|NCT00437489|P2|Participant Flow|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468763|NCT00437489|P1|Participant Flow|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468764|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468765|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468766|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468767|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468768|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468769|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468770|NCT00437489|O2|Outcome|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468771|NCT00437489|O1|Outcome|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468772|NCT00437489|E2|Reported Event|Exubera Dose (mg) as Per Weight Based Formula TID|Group B self-administered a dose of Exubera that was determined by the body weight-based formula = 0.05 x body weight (kg) TID.
468773|NCT00437489|E1|Reported Event|Exubera Dose of 1mg Three Times Daily (TID)|Subjects in Group A self-administered 1 mg Exubera TID before each meal (breakfast, lunch, and dinner)
468774|NCT00437398|B1|Baseline|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
468775|NCT00437398|P1|Participant Flow|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
468776|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
468777|NCT00437398|O1|Outcome|Islet Transplant|Subjects will receive standard intraportal transplantation or portal venous system infusion via laparotomy of purified pancreatic islets.
468780|NCT00437281|B20|Baseline|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468781|NCT00437281|B19|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468782|NCT00437281|B18|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468783|NCT00437281|B17|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468784|NCT00437281|B16|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468785|NCT00437281|B15|Baseline|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468786|NCT00437281|B14|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468787|NCT00437281|B13|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468788|NCT00437281|B12|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468789|NCT00437281|B11|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468790|NCT00437281|B10|Baseline|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468791|NCT00437281|B9|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468792|NCT00437281|B8|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468793|NCT00437281|B7|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468794|NCT00437281|B6|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468795|NCT00437281|B5|Baseline|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469337|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
468796|NCT00437281|B4|Baseline|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468797|NCT00437281|B3|Baseline|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468798|NCT00437281|B2|Baseline|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468799|NCT00437281|B1|Baseline|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468800|NCT00437281|P20|Participant Flow|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468801|NCT00437281|P19|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468802|NCT00437281|P18|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468803|NCT00437281|P17|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468804|NCT00437281|P16|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468805|NCT00437281|P15|Participant Flow|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468806|NCT00437281|P14|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468807|NCT00437281|P13|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468808|NCT00437281|P12|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468809|NCT00437281|P11|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468810|NCT00437281|P10|Participant Flow|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468811|NCT00437281|P9|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468812|NCT00437281|P8|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468813|NCT00437281|P7|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468814|NCT00437281|P6|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468815|NCT00437281|P5|Participant Flow|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468816|NCT00437281|P4|Participant Flow|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468817|NCT00437281|P3|Participant Flow|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468818|NCT00437281|P2|Participant Flow|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468819|NCT00437281|P1|Participant Flow|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468820|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468821|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468822|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468823|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468824|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468825|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468826|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468827|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469771|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
468828|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468829|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468830|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468831|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468832|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468833|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468834|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468835|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468836|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468837|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468838|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468839|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468840|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468841|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468842|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468843|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469286|NCT00437034|P1|Participant Flow|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
468844|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468845|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468846|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468847|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468848|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468849|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468850|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468851|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468852|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468853|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468854|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468855|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468856|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468857|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468858|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468859|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468860|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468861|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468862|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468863|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468864|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468865|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468866|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468867|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468868|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468869|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468870|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468871|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468872|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468873|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468874|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468875|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468876|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469140|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
468877|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468878|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468879|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468880|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468881|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468882|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468883|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468884|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468885|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468886|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468887|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468888|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468889|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468890|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468891|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468892|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468893|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468894|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468895|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468896|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468897|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468898|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468899|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468900|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468901|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468902|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468903|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468904|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468905|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468906|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468907|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468908|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468909|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469160|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
468910|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468911|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468912|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468913|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468914|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468915|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468916|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468917|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468918|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468919|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468920|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468921|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468922|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468923|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468924|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468925|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468926|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468927|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468928|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468929|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468930|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468931|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468932|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468933|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468934|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468935|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468936|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468937|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468938|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468939|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468940|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468941|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468942|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469180|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
468943|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468944|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468945|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468946|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468947|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468948|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468949|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468950|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468951|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468952|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468953|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468954|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468955|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468956|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468957|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468958|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469200|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
468959|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468960|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468961|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468962|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468963|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468964|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468965|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468966|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468967|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468968|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468969|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468970|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468971|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468972|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468973|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468974|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469220|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
468975|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468976|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468977|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468978|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468979|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468980|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468981|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468982|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468983|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468984|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468985|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468986|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468987|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468988|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468989|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468990|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469244|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469245|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
468991|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468992|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468993|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468994|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468995|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468996|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468997|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468998|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
468999|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469000|NCT00437281|O16|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469001|NCT00437281|O15|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469002|NCT00437281|O14|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469003|NCT00437281|O13|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469004|NCT00437281|O12|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469005|NCT00437281|O11|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469006|NCT00437281|O10|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469246|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469247|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469007|NCT00437281|O9|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469008|NCT00437281|O8|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469009|NCT00437281|O7|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469010|NCT00437281|O6|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469011|NCT00437281|O5|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469012|NCT00437281|O4|Outcome|Placebo, Pregabalin 7.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469013|NCT00437281|O3|Outcome|Placebo, Pregabalin 5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469014|NCT00437281|O2|Outcome|Placebo, Pregabalin 2.5 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469015|NCT00437281|O1|Outcome|Placebo, Pregabalin 1.25 mg/kg (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469016|NCT00437281|O16|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469017|NCT00437281|O15|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469018|NCT00437281|O14|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469019|NCT00437281|O13|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469020|NCT00437281|O12|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469021|NCT00437281|O11|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469022|NCT00437281|O10|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469248|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469249|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469023|NCT00437281|O9|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469024|NCT00437281|O8|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469025|NCT00437281|O7|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469026|NCT00437281|O6|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469027|NCT00437281|O5|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469028|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469029|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469030|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469031|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469032|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469033|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469034|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469035|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469036|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469037|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469038|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469250|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469039|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469040|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469041|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469042|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469043|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469044|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469045|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469046|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469047|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469048|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469049|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469050|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469051|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469052|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469053|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469054|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469251|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469055|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469056|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469057|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469058|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469059|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469060|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469061|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469062|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469063|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469064|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469065|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469066|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469067|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469068|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469069|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469070|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469252|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469071|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469072|NCT00437281|O20|Outcome|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469073|NCT00437281|O19|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469074|NCT00437281|O18|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469075|NCT00437281|O17|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469076|NCT00437281|O16|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469077|NCT00437281|O15|Outcome|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469078|NCT00437281|O14|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469079|NCT00437281|O13|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469080|NCT00437281|O12|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469081|NCT00437281|O11|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469082|NCT00437281|O10|Outcome|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469083|NCT00437281|O9|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469084|NCT00437281|O8|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469085|NCT00437281|O7|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469086|NCT00437281|O6|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469253|NCT00437125|E1|Reported Event|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469087|NCT00437281|O5|Outcome|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469088|NCT00437281|O4|Outcome|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469089|NCT00437281|O3|Outcome|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469090|NCT00437281|O2|Outcome|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469091|NCT00437281|O1|Outcome|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469092|NCT00437281|E20|Reported Event|Placebo (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469093|NCT00437281|E19|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469094|NCT00437281|E18|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469095|NCT00437281|E17|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469096|NCT00437281|E16|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 12 to 16 Years)|Participants of 12 to 16 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469097|NCT00437281|E15|Reported Event|Placebo (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received placebo matched to pregabalin oral liquid formulation or capsule 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg or 2.5 mg/kg, or pregabalin oral capsule 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469098|NCT00437281|E14|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469099|NCT00437281|E13|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral capsule 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral capsule 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469100|NCT00437281|E12|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469101|NCT00437281|E11|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 7 to 11 Years)|Participants of 7 to 11 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469102|NCT00437281|E10|Reported Event|Placebo (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469254|NCT00437073|B3|Baseline|Total|Total of all reporting groups
469103|NCT00437281|E9|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469104|NCT00437281|E8|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469105|NCT00437281|E7|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469106|NCT00437281|E6|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 2 to 6 Years)|Participants of 2 to 6 years of age received pregabalin oral liquid formulation 2.5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469107|NCT00437281|E5|Reported Event|Placebo (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received placebo matched to pregabalin oral liquid formulation 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg, 2.5 mg/kg, 5 mg/kg or 7.5mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469108|NCT00437281|E4|Reported Event|Pregabalin 15 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 15 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 7.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469109|NCT00437281|E3|Reported Event|Pregabalin 10 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 10 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469110|NCT00437281|E2|Reported Event|Pregabalin 5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 5 mg/kg/day in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 2.5 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469111|NCT00437281|E1|Reported Event|Pregabalin 2.5 mg/kg/Day (Age Cohort: 1 to 23 Months)|Participants of 1 to 23 months of age received pregabalin oral liquid formulation 2.5 milligram per kilogram per day (mg/kg/day) in 2 equally divided doses 12 hours apart for 7 days as double-blind treatment. Single open-label morning dose of pregabalin oral liquid formulation 1.25 mg/kg on Day 8. Participants who discontinued or did not enter open-label extension study were tapered off medication over 1 week.
469112|NCT00437203|B11|Baseline|Total|Total of all reporting groups
469113|NCT00437203|B10|Baseline|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469114|NCT00437203|B9|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469115|NCT00437203|B8|Baseline|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469116|NCT00437203|B7|Baseline|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469117|NCT00437203|B6|Baseline|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469118|NCT00437203|B5|Baseline|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469119|NCT00437203|B4|Baseline|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469120|NCT00437203|B3|Baseline|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469285|NCT00437034|B1|Baseline|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
469923|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
469121|NCT00437203|B2|Baseline|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469122|NCT00437203|B1|Baseline|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469123|NCT00437203|P10|Participant Flow|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469124|NCT00437203|P9|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469125|NCT00437203|P8|Participant Flow|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469126|NCT00437203|P7|Participant Flow|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469127|NCT00437203|P6|Participant Flow|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469128|NCT00437203|P5|Participant Flow|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469129|NCT00437203|P4|Participant Flow|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469130|NCT00437203|P3|Participant Flow|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469131|NCT00437203|P2|Participant Flow|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469132|NCT00437203|P1|Participant Flow|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 milligram (mg) 3 hours (hrs) infusion intravenously (IV) on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg per square meter (mg/m^2) 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469133|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469134|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469135|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469136|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469137|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469138|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469139|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469141|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469142|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469143|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469144|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469145|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469146|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469147|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469148|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469149|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469150|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469151|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469152|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469153|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469154|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469155|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469156|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469157|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469158|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469159|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469332|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469161|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469162|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469163|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469164|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469165|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469166|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469167|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469168|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469169|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469170|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469171|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469172|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469173|NCT00437203|O7|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469174|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469175|NCT00437203|O5|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469176|NCT00437203|O4|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469177|NCT00437203|O3|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469178|NCT00437203|O2|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469179|NCT00437203|O1|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469333|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469181|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469182|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469183|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469184|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469185|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469186|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469187|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469188|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469189|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469190|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469191|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469192|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469193|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469194|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469195|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469196|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469197|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469198|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469199|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469334|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469201|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469202|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469203|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469204|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469205|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469206|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469207|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469208|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469209|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469210|NCT00437203|O3|Outcome|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469211|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469212|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469213|NCT00437203|O10|Outcome|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469214|NCT00437203|O9|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469215|NCT00437203|O8|Outcome|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469216|NCT00437203|O7|Outcome|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469217|NCT00437203|O6|Outcome|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469218|NCT00437203|O5|Outcome|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469219|NCT00437203|O4|Outcome|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469335|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469221|NCT00437203|O2|Outcome|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469222|NCT00437203|O1|Outcome|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469223|NCT00437203|O2|Outcome|PF-00477736 + Gemcitabine 1000 mg/m^2|PF-00477736 infusion 180 mg or 225 mg IV administered over 24 hrs on Days 2 and 9 of each cycle (21 days cycle) along with gemcitabine infusion 1000 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469224|NCT00437203|O1|Outcome|PF-00477736 + Gemcitabine 750 mg/m^2|PF-00477736 infusion 50 mg, 65 mg or 80 mg IV administered over 3 hrs on Days 1 and 8 of Cycle 0 (21 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle), or PF-00477736 infusion 80 mg, 120 mg, 180 mg, 270 mg or 340 mg IV administered over 24 hrs on Days 1 and 8 of Cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 750 mg/m^2 IV administered over 30 minutes on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469225|NCT00437203|E10|Reported Event|PF-00477736 225 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (cohort10)|PF-00477736 infusion 225 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469226|NCT00437203|E9|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 1000 mg/m^2 (Cohort 9)|PF-00477736 infusion 180 mg 24 hrs infusion IV on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine infusion 1000 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle).
469227|NCT00437203|E8|Reported Event|PF-00477736 340 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 8)|PF-00477736 340 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469228|NCT00437203|E7|Reported Event|PF-00477736 270 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 7)|PF-00477736 270 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469229|NCT00437203|E6|Reported Event|PF-00477736 180 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 6)|PF-00477736 180 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469230|NCT00437203|E5|Reported Event|PF-00477736 120 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 5)|PF-00477736 120 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469231|NCT00437203|E4|Reported Event|PF-00477736 80 mg 24 Hrs + Gemcitabine 750 mg/m^2 (Cohort 4)|PF-00477736 80 mg 24 hrs infusion IV on Days 1 and 8 of cycle 0 (14 days cycle) and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469232|NCT00437203|E3|Reported Event|PF-00477736 80 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 3)|PF-00477736 80 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle). Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469233|NCT00437203|E2|Reported Event|PF-00477736 65 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 2)|PF-00477736 65 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469234|NCT00437203|E1|Reported Event|PF-00477736 50 mg 3 Hrs + Gemcitabine 750 mg/m^2 (Cohort 1)|PF-00477736 50 mg 3 hrs infusion IV on Days 1 and 8 of cycle 0 and subsequently on Days 2 and 9 of each cycle (21 days cycle) for first 3 participants and on Days 2 and 9 of each cycle (21 days cycle), starting with cycle 1, for participants subsequently enrolled in this cohort. Gemcitabine 750 mg mg/m^2 30 minutes infusion IV on Days 1 and 8 of each cycle (21 days cycle), starting with cycle 1.
469235|NCT00437125|B1|Baseline|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469236|NCT00437125|P1|Participant Flow|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469237|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469238|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469239|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469240|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469241|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469242|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469243|NCT00437125|O1|Outcome|Duloxetine|Participants received duloxetine 30 milligram (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg orally QD for 11 weeks
469255|NCT00437073|B2|Baseline|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469256|NCT00437073|B1|Baseline|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469257|NCT00437073|P2|Participant Flow|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469258|NCT00437073|P1|Participant Flow|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469259|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469260|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469261|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469262|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469263|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469264|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469265|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469266|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469267|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469268|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469269|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469772|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469270|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469271|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469272|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469273|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469274|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469275|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469276|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469277|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469278|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469279|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469280|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469281|NCT00437073|O2|Outcome|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469282|NCT00437073|O1|Outcome|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469283|NCT00437073|E2|Reported Event|Lapatinib Plus Topotecan|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received an intravenous (IV) infusion of topotecan 3.2 mg/m^2 over the course of at least 30 minutes on Days 1, 8, and 15 (+/- 2 days) of a 28-day treatment cycle.
469284|NCT00437073|E1|Reported Event|Lapatinib Plus Capecitabine|Participants received a daily dose of 5 tablets of lapatinib (1250 milligrams [mg]) at approximately the same time every day, either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received capecitabine 2000 mg per meters squared (mg/m^2) per day, divided and administered orally twice daily, 12 hours apart, for 14 days, every 21 days. Capecitabine was taken with food or within 30 minutes after a breakfast meal with approximately 200 milliliters (ml) of water.
469287|NCT00437034|O1|Outcome|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
469288|NCT00437034|E1|Reported Event|Treatment (Antiangiogenesis Therapy)|"Patients receive aflibercept IV over 1 hour on day 1. Treatment repeats every 2 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~aflibercept: Given IV"
469289|NCT00436982|B3|Baseline|Total|Total of all reporting groups
469290|NCT00436982|B2|Baseline|Duracon|30 patients randomized into the Duracon arm
469291|NCT00436982|B1|Baseline|Triathlon|30 patients randomized into the Triathlon arm
469292|NCT00436982|P2|Participant Flow|Duracon Total Knee System|"30 patients were randomized into the Duracon total knee system arm. The Duracon total knee system is the predecessor of the Triathlon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Duracon total knee system: Orthopaedic implant"
469293|NCT00436982|P1|Participant Flow|Cemented Triathlon Total Knee System|"30 patients were randomized into the Triathlon total knee system arm. TheTriathlon total knee system is the successor of the Duracon total knee system and was observed in a prospective randomised, parallel, double-blind study.~Cemented Triathlon total knee system: Orthopaedic implant"
469294|NCT00436982|O2|Outcome|Duracon|30 patients randomized into the Duracon arm
469295|NCT00436982|O1|Outcome|Triathlon|30 patients randomized into the Triathlon arm
469296|NCT00436982|E2|Reported Event|Duracon|30 patients randomized into the Duracon arm
469297|NCT00436982|E1|Reported Event|Triathlon|30 patients randomized into the Triathlon arm
469298|NCT00436969|B3|Baseline|Total|Total of all reporting groups
469299|NCT00436969|B2|Baseline|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469300|NCT00436969|B1|Baseline|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469301|NCT00436969|P2|Participant Flow|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469302|NCT00436969|P1|Participant Flow|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469303|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469304|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469305|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469306|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469307|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469308|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469309|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469310|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469311|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469312|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469313|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469314|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469315|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469316|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469317|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469318|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469319|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469320|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469321|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469322|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469323|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469324|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469325|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469326|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469327|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469328|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469329|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469330|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469331|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469338|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469339|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469340|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469341|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469342|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469343|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469344|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469345|NCT00436969|O2|Outcome|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469346|NCT00436969|O1|Outcome|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine) and 2 mL of corticosteroid (Celestone).
469347|NCT00436969|E2|Reported Event|Investigational|Each subject received a one-time injection of 8 mL's of Orthovisc into the target shoulder.
469348|NCT00436969|E1|Reported Event|Control|Each subject received a one-time injection containing 6 mL of anesthetic (Marcaine)and 2 mL of corticosteroid (Celestone).
469349|NCT00436956|B1|Baseline|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
469350|NCT00436956|P2|Participant Flow|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
469351|NCT00436956|P1|Participant Flow|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
469352|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
469353|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
469354|NCT00436956|O2|Outcome|20 mg AZD2171 + 10mg Prednisone Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone.
469355|NCT00436956|O1|Outcome|20 mg AZD2171 Daily|Participants received 20 mg AZD2171 (Cediranib) orally daily.
469356|NCT00436956|O1|Outcome|All Participants- AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
469357|NCT00436956|O1|Outcome|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
469358|NCT00436956|E1|Reported Event|All Participants - AZD2171 & Prednisone|This group combines participants who received 20 mg AZD2171 (Cediranib) orally daily (n=35), in addition to participants who received 20 mg AZD2171 (Cediranib) orally daily plus 10mg prednisone (n=23). One pt was not evaluable due to a cord compression on day 2 of therapy; was removed from the trial (n=1).
469359|NCT00436917|B1|Baseline|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
469360|NCT00436917|P1|Participant Flow|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
469361|NCT00436917|O1|Outcome|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
469362|NCT00436917|E1|Reported Event|Zoledronic Acid|4 mg intravenously over 15 minutes every 6 months (until disease progression or for 5 years)
469363|NCT00436904|B1|Baseline|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469364|NCT00436904|P1|Participant Flow|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469365|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469366|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469367|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469368|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469369|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469370|NCT00436904|O1|Outcome|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469371|NCT00436904|E1|Reported Event|Alemtuzumab + Rituximab|Alemtuzumab 30mg Monday, Wednesday, and Friday x 5 weeks, Rituximab 375/mg/m2 IV weekly (Wednesday) x 4 weeks (weeks 2-5)
469372|NCT00436852|B3|Baseline|Total|Total of all reporting groups
469373|NCT00436852|B2|Baseline|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
469374|NCT00436852|B1|Baseline|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
469375|NCT00436852|P2|Participant Flow|Measurable Disease by CT or MRI Scan (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
469376|NCT00436852|P1|Participant Flow|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients receive oral ABT-751 (200 mg/m2) once daily on days 1-7. Treatment repeats every 21 days for 52 courses in the absence of disease progression or unacceptable toxicity. Quality-of-life assessment at baseline and prior to each course of treatment. A pharmacological study (pharmacokinetic profile of ABT-751) will be determined.
469377|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469378|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469379|NCT00436852|O2|Outcome|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469380|NCT00436852|O1|Outcome|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469381|NCT00436852|E2|Reported Event|Measurable Disease by CT or MRI Scan (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469382|NCT00436852|E1|Reported Event|Disease Evaluable by I-MIBG Scintigraphy (ABT-751)|Patients who met study eligibility criteria and receive at least one dose of oral ABT-751 were evaluable for the efficacy analysis.
469383|NCT00436826|B3|Baseline|Total|Total of all reporting groups
469384|NCT00436826|B2|Baseline|Placebo, IFN-beta|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
469385|NCT00436826|B1|Baseline|Cladribine 3.5 mg/kg, IFN-beta|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks. After completing DB period, participants entered in OL extension period. In OL extension period, participant who met eligibility criteria received OL oral cladribine 3.5 mg/kg and participants who did not meet the eligibility criteria received IFN-beta only and were followed for safety only.
469386|NCT00436826|P6|Participant Flow|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469387|NCT00436826|P5|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469388|NCT00436826|P4|Participant Flow|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469389|NCT00436826|P3|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469390|NCT00436826|P2|Participant Flow|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469391|NCT00436826|P1|Participant Flow|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (Rebif® new formulation [RNF] 44 microgram [mcg] three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the double blind (DB) period of 96 weeks.
469392|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469581|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469393|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469394|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469395|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469396|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469397|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469398|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469399|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469400|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469401|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469402|NCT00436826|O2|Outcome|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469403|NCT00436826|O1|Outcome|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469404|NCT00436826|E6|Reported Event|Placebo, IFN-beta (Safety Follow up)|Participants who received placebo initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469405|NCT00436826|E5|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (Safety Follow up)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the OL ext. safety follow up period. In this period, participants who did not meet eligibility criteria received only IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469406|NCT00436826|E4|Reported Event|Placebo, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received placebo initially and completed DB period entered in the OL Ext. period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469407|NCT00436826|E3|Reported Event|Cladribine 3.5 mg/kg, IFN-beta, Cladribine 3.5 mg/kg (OL Ext)|Participants who received cladribine 3.5 mg/kg initially and completed DB period entered in the open label (OL) extension (Ext.) period. In OL Ext. period, participant who met the eligibility criteria received OL oral cladribine 3.5 mg/kg over maximum of 48 weeks along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) up to 48 weeks.
469431|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469408|NCT00436826|E2|Reported Event|Placebo, IFN-beta (DB Period)|Participants received matching placebo tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total matching placebo dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469409|NCT00436826|E1|Reported Event|Cladribine 3.5 mg/kg, IFN-beta (DB Period)|Participants received cladribine tablets orally as cumulative dose of 0.875 mg/kg over a course of 4-5 consecutive days at Week 1, 5, 48, and 52 resulting in total cladribine dose of 3.5 mg/kg along with IFN-beta therapy (RNF 44 mcg three times a week, subcutaneously; Avonex® 30 mcg every week, intramuscularly; or Betaseron® 250 mcg every other day, subcutaneously) during the DB period of 96 weeks.
469410|NCT00436644|B1|Baseline|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469411|NCT00436644|P1|Participant Flow|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469412|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469413|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469414|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469415|NCT00436644|O1|Outcome|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469416|NCT00436644|E1|Reported Event|Lapatinib + Topotecan|Assess biological effects of topotecan and lapatinib in patients with epithelial ovarian cancer and primary peritoneal carcinoma.
469417|NCT00436618|B4|Baseline|Total|Total of all reporting groups
469418|NCT00436618|B3|Baseline|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469419|NCT00436618|B2|Baseline|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469420|NCT00436618|B1|Baseline|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469421|NCT00436618|P3|Participant Flow|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469422|NCT00436618|P2|Participant Flow|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469423|NCT00436618|P1|Participant Flow|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469424|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469425|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469426|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469427|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469428|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469429|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469430|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469432|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469433|NCT00436618|O3|Outcome|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469434|NCT00436618|O2|Outcome|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469435|NCT00436618|O1|Outcome|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469436|NCT00436618|E3|Reported Event|Uncommon Lymphomas|"Study 3. Includes Hodgkin's lymphomas.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469437|NCT00436618|E2|Reported Event|Relapsed Indolent Non-Hodgkin Lymphoma|"Study 2.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469438|NCT00436618|E1|Reported Event|Relapsed Aggressive Non-Hodgkin Lymphoma|"Study 1.~Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time.~Everolimus : Everolimus 10 mg orally daily for 4 week cycle. Repeat until progression, unacceptable toxicity, refusal, or alternative therapy at any time."
469439|NCT00436605|B1|Baseline|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
469440|NCT00436605|P1|Participant Flow|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
469441|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
469442|NCT00436605|O1|Outcome|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
469443|NCT00436605|E1|Reported Event|Treatment (Kinase Inhibitor Therapy)|Patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
469444|NCT00436566|B1|Baseline|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
469445|NCT00436566|P1|Participant Flow|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
469446|NCT00436566|O1|Outcome|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
469447|NCT00436566|E1|Reported Event|AC/PTL|Standard doxorubicin and cyclophosphamide (AC) followed by weekly paclitaxel (80 mg/m^2) x 12 with concurrent standard dose trastuzumab (weekly x 12, then repeat 3 weeks for an additional 9 months) plus daily lapatinib (modified to 750 mg during Paclitaxel + Trastuzumab + Lapatinib (PTL) and 1000 mg during trastuzumab + lapatinib (TL)) for a total of 12 months.
469448|NCT00436553|B4|Baseline|Total|Total of all reporting groups
469449|NCT00436553|B3|Baseline|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469450|NCT00436553|B2|Baseline|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469582|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469451|NCT00436553|B1|Baseline|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469452|NCT00436553|P3|Participant Flow|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469453|NCT00436553|P2|Participant Flow|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469454|NCT00436553|P1|Participant Flow|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469455|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469456|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469457|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469458|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469720|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469459|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469460|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469461|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469462|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469463|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469464|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469465|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469466|NCT00436553|O3|Outcome|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469483|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
469467|NCT00436553|O2|Outcome|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469468|NCT00436553|O1|Outcome|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469469|NCT00436553|E3|Reported Event|Ranibizumab Monotherapy|Patients received monthly ranibizumab injections for 12 months and thereafter as needed based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. Retreatments were determined based on study specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA).
469470|NCT00436553|E2|Reported Event|Verteporfin RF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT with reduced fluence (RF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469471|NCT00436553|E1|Reported Event|Verteporfin SF + Ranibizumab|Patients received three consecutive monthly ranibizumab injections on Day 1 and at Months 1 and 2, and thereafter as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin photodynamic therapy (PDT) with standard fluence (SF) rate on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and choroidal neovascularization (CNV) leakage assessed by fluorescein angiography (FA). Patients received sham intravitreal injections for the first 12 months if retreatment with ranibizumab was not warranted based on the retreatment criteria.
469472|NCT00436501|B3|Baseline|Total|Total of all reporting groups
469473|NCT00436501|B2|Baseline|Phase II VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469474|NCT00436501|B1|Baseline|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
469475|NCT00436501|P2|Participant Flow|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469476|NCT00436501|P1|Participant Flow|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
469477|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469478|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469479|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469480|NCT00436501|O1|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469481|NCT00436501|O2|Outcome|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469482|NCT00436501|O1|Outcome|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
469484|NCT00436501|E2|Reported Event|Phase II: VEGF Trap, Docetaxel|Phase II VEGF Trap 6 mg/kg (the MTD determined in Phase I) and Docetaxel 75 mg/m^2 as in Phase I. Courses repeat every 21 days.
469485|NCT00436501|E1|Reported Event|Phase I VEGF Trap, Docetaxel|Phase I VEGF Trap starting dose 2 mg/kg intravenous (IV) over 1 hour on day 1 of course 1, then VEGF Trap IV and Docetaxel 75 mg/m^2 IV over 1 hour on day 1 in all subsequent courses. Courses repeat every 21 days. Escalating doses of VEGF Trap (2, 4, or 6 mg/kg) until maximum tolerated dose (MTD) determined.
469486|NCT00436345|B3|Baseline|Total|Total of all reporting groups
469487|NCT00436345|B2|Baseline|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469488|NCT00436345|B1|Baseline|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469489|NCT00436345|P2|Participant Flow|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469490|NCT00436345|P1|Participant Flow|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469491|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469492|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469493|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469494|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469495|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469496|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469497|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469498|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469499|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per killograms per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469500|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469501|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469502|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469503|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469721|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469504|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469505|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469506|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469507|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469508|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469509|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469510|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469511|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469512|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469513|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469514|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469515|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469516|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469517|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469518|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469519|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469520|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469521|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469522|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469523|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469524|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469525|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469526|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469527|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469528|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469529|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469530|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469531|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469532|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469533|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469534|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469535|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469536|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469537|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469538|NCT00436345|O2|Outcome|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469539|NCT00436345|O1|Outcome|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469540|NCT00436345|E2|Reported Event|Propofol|The administration of propofol combined with an opioid (fentanyl, sufentanil, morphine, or other) as required to maintain adequate analgesia/sedation and stable haemodynamics was performed according to routine clinical practice for the investigational site, and in accordance with standard clinical protocols.
469580|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469910|NCT00435162|P4|Participant Flow|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then placebo
469541|NCT00436345|E1|Reported Event|Remifentanil|Infusion started between 6 and 9 ug/kg/h (micrograms per kilogram per hour), and titrated in 1.5 ug/kg/h increments at 5-10 minute intervals to achieve a level of adequate sedation based on investigator clinical judgement. The maximum dose rate was 45 ug/kg/h. Once the remifentanil infusion rate reached 12 ug/kg/h, the sedative infusion (propofol) could be administered if level of sedation was not adequate.
469542|NCT00436332|B1|Baseline|Erlotinib and Bevacizumab|"bevacizumab~erlotinib hydrochloride"
469543|NCT00436332|P1|Participant Flow|Erlotinib and Bevacizumab|"bevacizumab~erlotinib hydrochloride"
469544|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|"bevacizumab~erlotinib hydrochloride"
469545|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|"bevacizumab~erlotinib hydrochloride"
469546|NCT00436332|O1|Outcome|Erlotinib and Bevacizumab|"bevacizumab~erlotinib hydrochloride"
469547|NCT00436332|E1|Reported Event|Erlotinib and Bevacizumab|Patients receive oral erlotinib hydrochloride once daily on days 1-21 and bevacizumab IV over 30-90 minutes on day 1.
469548|NCT00436215|B1|Baseline|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469549|NCT00436215|P1|Participant Flow|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469550|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469551|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469552|NCT00436215|O1|Outcome|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469553|NCT00436215|E1|Reported Event|BAY 43-9006 + Bevacizumab|"BAY 43-9006 (sorafenib) + Bevacizumab~Bevacizumab: bevacizumab 5 mg/kg intravenous (IV) every two weeks~BAY 43-9006: BAY 43-9006 200 mg po (by mouth) twice daily 5 out of 7 days each week (Mon-Fri)"
469554|NCT00436163|B1|Baseline|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469555|NCT00436163|P1|Participant Flow|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously once per week for 48 weeks.
469556|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469557|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469558|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469559|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
469560|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys)180 mcg subcutaneously once per week for 48 weeks.
469561|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469562|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469563|NCT00436163|O1|Outcome|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469564|NCT00436163|E1|Reported Event|Peginterferon Alfa-2a|Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
469565|NCT00436046|B4|Baseline|Total|Total of all reporting groups
469566|NCT00436046|B3|Baseline|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469567|NCT00436046|B2|Baseline|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469568|NCT00436046|B1|Baseline|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469569|NCT00436046|P3|Participant Flow|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469570|NCT00436046|P2|Participant Flow|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469571|NCT00436046|P1|Participant Flow|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469572|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469573|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469574|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469575|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469576|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469577|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469578|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469579|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469583|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469584|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469585|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469586|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469587|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469588|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469589|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469590|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469591|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469592|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469593|NCT00436046|O3|Outcome|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469594|NCT00436046|O2|Outcome|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469595|NCT00436046|O1|Outcome|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469596|NCT00436046|E3|Reported Event|IVV With 10M IFN|IVV plus 10 Molar units of IFN: 0.7 ml of the mixture will be given [0.5 ml of vaccine plus 0.2 ml (10 Molar units) of IFN].
469597|NCT00436046|E2|Reported Event|IVV Without IFN|IVV only: 0.6 ml of IVV alone (0.5 ml of vaccine plus 0.1 ml of saline).
469598|NCT00436046|E1|Reported Event|IVV With 1M IFN|IVV (inactivated influenza virus vaccine) plus 1 Molar unit of IFN (Interferon): 0.6ml of the mixture will be given [0.5 ml of vaccine plus 0.1 ml (1 Molar unit) of IFN].
469599|NCT00436007|B4|Baseline|Total|Total of all reporting groups
469600|NCT00436007|B3|Baseline|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469601|NCT00436007|B2|Baseline|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469602|NCT00436007|B1|Baseline|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469603|NCT00436007|P3|Participant Flow|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469604|NCT00436007|P2|Participant Flow|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469605|NCT00436007|P1|Participant Flow|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469606|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469607|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469608|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469609|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469610|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469611|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469612|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469613|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469614|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469615|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469677|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469911|NCT00435162|P3|Participant Flow|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
469616|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469617|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469618|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469619|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469620|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469621|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469622|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469623|NCT00436007|O2|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469624|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469625|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469678|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469722|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469626|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469627|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469628|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469629|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469630|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469631|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469632|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469633|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469634|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469635|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469679|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469912|NCT00435162|P2|Participant Flow|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then placebo
469636|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469637|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania
469638|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469639|NCT00436007|O1|Outcome|GSK 257049 1 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469640|NCT00436007|O1|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469641|NCT00436007|O1|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469642|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469643|NCT00436007|O3|Outcome|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469644|NCT00436007|O2|Outcome|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469645|NCT00436007|O1|Outcome|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469680|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469723|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469646|NCT00436007|E3|Reported Event|Tritanrix™ HepB/Hiberix™ Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469647|NCT00436007|E2|Reported Event|GSK 257049 2 Group|Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib and Polio Sabin™ at Months 0, 1 and 2, 3 doses of GSK 257049 vaccine at Months 0, 1 and 7, and a single dose of Rouvax™ and Stamaril™ at Month 7. The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. Stamaril™ was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania.
469648|NCT00436007|E1|Reported Event|GSK 257049 1 Group|"Subjects aged 6 to 10 weeks at the time of first vaccination received 3 doses of Tritanrix™ HepB/Hib, Polio Sabin™ and GSK 257049 vaccines at Months 0, 1 and 2, and a single dose of Rouvax™ and Stamaril™ vaccines at Month 7.~The GSK 257049 and Tritanrix™ HepB/Hib vaccines were administered intramuscularly in the left and right antero-lateral thigh, respectively. Rouvax™ and Stamaril™ were administered intramuscularly in the left and right arm respectively. Polio Sabin™ was administered orally. The Stamaril™ vaccine was not administered to subjects from Tanzania as this vaccine was not foreseen at the time to be introduced to the EPI vaccination schedule in Tanzania."
469649|NCT00435994|B4|Baseline|Total|Total of all reporting groups
469650|NCT00435994|B3|Baseline|Bronchiolitis|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
469651|NCT00435994|B2|Baseline|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
469652|NCT00435994|B1|Baseline|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
469653|NCT00435994|P3|Participant Flow|Bronchiolitis-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis received nasal wash only.
469654|NCT00435994|P2|Participant Flow|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
469655|NCT00435994|P1|Participant Flow|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
469656|NCT00435994|O2|Outcome|Bronchiolitis and Respiratory Syncytial Virus-Nasal Wash Only|Infants 2 months to 24 months who were diagnosed with bronchiolitis and respiratory syncytial virus received nasal wash only.
469657|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity
469658|NCT00435994|O2|Outcome|Respiratory Syncytial Virus|Infants between the ages of 2-24 month, with viral lower respiratory infection defined as first episode of wheezing and shortness of breath preceded by a URI
469659|NCT00435994|O1|Outcome|Healthy Control|Healthy infants between the ages of 2-24 month without a history of congenital heart disease or prematurity had spirometry performed under sedation.
469660|NCT00435994|E3|Reported Event|Bronchiolitis|
469661|NCT00435994|E2|Reported Event|Respiratory Syncytial Virus|
469662|NCT00435994|E1|Reported Event|Healthy Control|
469663|NCT00435929|B3|Baseline|Total|Total of all reporting groups
469664|NCT00435929|B2|Baseline|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469665|NCT00435929|B1|Baseline|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469666|NCT00435929|P2|Participant Flow|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469667|NCT00435929|P1|Participant Flow|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469668|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469669|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469670|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469671|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469672|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469673|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469674|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469675|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469676|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469681|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469682|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469683|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469684|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469685|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469686|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469687|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469688|NCT00435929|O2|Outcome|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469689|NCT00435929|O1|Outcome|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469690|NCT00435929|E2|Reported Event|Moderate Hepatic Impairment|Participants with HIV infection and with moderate hepatic impairment receiving SQV/RTV 1000/100 mg orally BID for 14 days.
469691|NCT00435929|E1|Reported Event|Normal Liver Function|Participants with human immunodeficiency virus (HIV) infection and with normal liver function receiving saquinavir (SQV)/ritonavir (RTV) 1000/100 mg orally twice a day (BID) for 14 days.
469692|NCT00435825|B5|Baseline|Total|Total of all reporting groups
469693|NCT00435825|B4|Baseline|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469694|NCT00435825|B3|Baseline|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469695|NCT00435825|B2|Baseline|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469696|NCT00435825|B1|Baseline|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469697|NCT00435825|P4|Participant Flow|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469698|NCT00435825|P3|Participant Flow|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469699|NCT00435825|P2|Participant Flow|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469700|NCT00435825|P1|Participant Flow|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469701|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469702|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469703|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469704|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469705|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469706|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469707|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469708|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469709|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469710|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469711|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469712|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469713|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469714|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469715|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469716|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469717|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469718|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469719|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469770|NCT00435591|O1|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469724|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469725|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469726|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469727|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469728|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469729|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469730|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469731|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469732|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469733|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469734|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469735|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469736|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469737|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469738|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469739|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469740|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469741|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469742|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469743|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469744|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469745|NCT00435825|O4|Outcome|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469746|NCT00435825|O3|Outcome|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469747|NCT00435825|O2|Outcome|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469748|NCT00435825|O1|Outcome|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469749|NCT00435825|E4|Reported Event|Peginterferon Alfa-2a 180 μg_48 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469750|NCT00435825|E3|Reported Event|Peginterferon Alfa-2a 90 μg_48 Weeks|Participants received 90 μg peginterferon alfa-2a subcutaneous once a week for 48 weeks.
469751|NCT00435825|E2|Reported Event|Peginterferon Alfa-2a 180 μg_24 Weeks|Participants received 180 μg peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469752|NCT00435825|E1|Reported Event|Peginterferon Alfa-2a 90 μg_24 Weeks|Participants received 90 micrograms (μg) peginterferon alfa-2a subcutaneous once a week for 24 weeks.
469753|NCT00435591|B5|Baseline|Total|Total of all reporting groups
469754|NCT00435591|B4|Baseline|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
469755|NCT00435591|B3|Baseline|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469756|NCT00435591|B2|Baseline|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469757|NCT00435591|B1|Baseline|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469758|NCT00435591|P4|Participant Flow|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
469759|NCT00435591|P3|Participant Flow|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469760|NCT00435591|P2|Participant Flow|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469761|NCT00435591|P1|Participant Flow|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469762|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
469763|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469764|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469765|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469766|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20mg)+20mg/day continuous infusion conivaptan per premix bag
469767|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20mg/day continuous infusion conivaptan per premix bag
469768|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469769|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469773|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469774|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469775|NCT00435591|O4|Outcome|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
469776|NCT00435591|O3|Outcome|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469777|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469778|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469779|NCT00435591|O2|Outcome|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469780|NCT00435591|O1|Outcome|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469781|NCT00435591|E4|Reported Event|Dose Regimen 4|Conivaptan loading dose (20 mg) + 20 mg/day continuous infusion conivaptan per premix bag
469782|NCT00435591|E3|Reported Event|Dose Regimen 3|Placebo loading dose + 20 mg/day continuous infusion conivaptan per premix bag
469783|NCT00435591|E2|Reported Event|Dose Regimen 2|Conivaptan loading dose (20mg)+ 20mg/day continuous infusion conivaptan per ampoule
469784|NCT00435591|E1|Reported Event|Dose Regimen 1|Placebo loading dose + 20mg/day continuous infusion conivaptan per ampoule
469785|NCT00435539|B6|Baseline|Total|Total of all reporting groups
469786|NCT00435539|B5|Baseline|Sham Injection|sham injection
469787|NCT00435539|B4|Baseline|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
469788|NCT00435539|B3|Baseline|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
469789|NCT00435539|B2|Baseline|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
469790|NCT00435539|B1|Baseline|Ocriplasmin 75µg Single Injection|ocriplasmin 75µg single injection versus sham injection
469791|NCT00435539|P5|Participant Flow|Sham Injection|sham injection
469792|NCT00435539|P4|Participant Flow|Ocriplasmin 125µg Multiple Injections|ocriplasmin 125µg multiple injections. Subjects who did not achieve resolution of VMT by the day 28 visit (i.e. non-responders) were given an open-label injection of ocriplasmin 125 μg. Subjects who still did not achieve resolution of VMT by the day 56 visit were given a second open-label injection of ocriplasmin 125 μg.
469793|NCT00435539|P3|Participant Flow|Ocriplasmin 175µg Single Injection|ocriplasmin 175µg single injection versus sham injection
469794|NCT00435539|P2|Participant Flow|Ocriplasmin 125µg Single Injection|ocriplasmin 125µg single injection versus sham injection
469795|NCT00435539|P1|Participant Flow|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
469796|NCT00435539|O4|Outcome|Sham Injection|sham injection
469797|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
469798|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
469799|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
469800|NCT00435539|O4|Outcome|Sham Injection|sham injection
469801|NCT00435539|O3|Outcome|Ocriplasmin 125µg Pooled|Pooled data for ocriplasmin 125µg and ocriplasmin 125µg multiple injections versus sham injection
469802|NCT00435539|O2|Outcome|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
469803|NCT00435539|O1|Outcome|Ocriplasmin 75µg Single Injection|Ocriplasmin 75µg single injection versus sham injection
469804|NCT00435539|E5|Reported Event|Sham Injection|Sham injection
469805|NCT00435539|E4|Reported Event|Ocriplasmin 125µg Multiple Injection|Ocriplasmin 125µg multiple injection versus sham injection
469806|NCT00435539|E3|Reported Event|Ocriplasmin 175µg Single Injection|Ocriplasmin 175µg single injection versus sham injection
469807|NCT00435539|E2|Reported Event|Ocriplasmin 125µg Single Injection|Ocriplasmin 125µg single injection versus sham injection
469808|NCT00435539|E1|Reported Event|Ocriplasmin 75µg|Ocriplasmin 75µg single injection versus sham injection
469809|NCT00435487|B3|Baseline|Total|Total of all reporting groups
469810|NCT00435487|B2|Baseline|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469811|NCT00435487|B1|Baseline|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469812|NCT00435487|P2|Participant Flow|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469813|NCT00435487|P1|Participant Flow|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469814|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469913|NCT00435162|P1|Participant Flow|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
469914|NCT00435162|O2|Outcome|Placebo|
469815|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469816|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469817|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469818|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469819|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469820|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469821|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469822|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469823|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469824|NCT00435487|O2|Outcome|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469825|NCT00435487|O1|Outcome|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469826|NCT00435487|E2|Reported Event|Arm B: Unfractioned Heparin (UFH)|Weight-adjusted nomogram (bolus of 60 units per kilogram [U/kg] and initial infusion of 12 units per kilogram per hour [U/kg/h]); given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469827|NCT00435487|E1|Reported Event|Arm A: Dalteparin|120 international units per kilogram (IU/kg) total body weight subcutaneously (SC) every 12 hours up to a maximum dose of 10,000 IU/12 hours; given for a minimum of 48 hours and until no further anticoagulation is required, and at least through angiography and percutaneous coronary intervention (PCI), if performed.
469828|NCT00435409|B3|Baseline|Total|Total of all reporting groups
469829|NCT00435409|B2|Baseline|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469830|NCT00435409|B1|Baseline|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469831|NCT00435409|P3|Participant Flow|Capecitabine, Crossover to Sunitinib|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469832|NCT00435409|P2|Participant Flow|Capecitabine, no Crossover|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks.
469833|NCT00435409|P1|Participant Flow|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 milligrams (mg) once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 milligrams per square meter (mg/m^2) per day (1000 mg/m^2 twice daily [BID]) from Days 1-14 every 3 weeks.
469834|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469835|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469836|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469915|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
469916|NCT00435162|O2|Outcome|Placebo|
469837|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469838|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469839|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469840|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469841|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469842|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469843|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469844|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469845|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469846|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469847|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469848|NCT00435409|O2|Outcome|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469849|NCT00435409|O1|Outcome|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469850|NCT00435409|E2|Reported Event|Capecitabine|Capecitabine administered orally at a starting dose of 2500 mg/m^2 per day (1250 mg/m^2 BID) from Days 1-14 every 3 weeks. At the time of progression, participants could have been eligible to crossover to single agent sunitinib, administered orally at a starting dose of 37.5 mg daily continuously.
469851|NCT00435409|E1|Reported Event|Sunitinib + Capecitabine|Sunitinib administered orally at a starting dose of 37.5 mg once a day on a continuous regimen. Capecitabine administered orally at a starting dose of 2000 mg/m^2 per day (1000 mg/m^2 BID) from Days 1-14 every 3 weeks.
469852|NCT00435370|B3|Baseline|Total|Total of all reporting groups
469853|NCT00435370|B2|Baseline|Placebo|Placebo + risperidone (6mg/day)
469854|NCT00435370|B1|Baseline|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
469855|NCT00435370|P2|Participant Flow|Placebo|Placebo + risperidone (6mg/day)
469856|NCT00435370|P1|Participant Flow|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
469857|NCT00435370|O2|Outcome|Placebo|Placebo + risperidone (6mg/day)
469858|NCT00435370|O1|Outcome|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
469859|NCT00435370|E2|Reported Event|Placebo|Placebo + risperidone (6mg/day)
469860|NCT00435370|E1|Reported Event|Tropisetron|Tropisetron (10mg/day) + risperidone(6mg/day)
469861|NCT00435188|B3|Baseline|Total|Total of all reporting groups
469862|NCT00435188|B2|Baseline|Arm 2|Usual care
469863|NCT00435188|B1|Baseline|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic vis
469864|NCT00435188|P2|Participant Flow|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
469865|NCT00435188|P1|Participant Flow|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469866|NCT00435188|O2|Outcome|Arm 2|Usual care
469917|NCT00435162|O1|Outcome|Valsartan|pooled across all dosage levels
469918|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
469919|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
469867|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469868|NCT00435188|O2|Outcome|Arm 2|Usual care
469869|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469870|NCT00435188|O2|Outcome|Arm 2|Usual care
469871|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469872|NCT00435188|O2|Outcome|Arm 2|Usual care
469873|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469874|NCT00435188|O2|Outcome|Arm 2|Usual care
469875|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469876|NCT00435188|O2|Outcome|Arm 2|Usual care
469877|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469878|NCT00435188|O2|Outcome|Arm 2|Usual care
469879|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469880|NCT00435188|O2|Outcome|Arm 2|Usual care
469881|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469882|NCT00435188|O2|Outcome|Arm 2|Usual care
469883|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469884|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
469885|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469886|NCT00435188|O2|Outcome|Arm 2|Usual care
469920|NCT00435162|O1|Outcome|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
469921|NCT00435162|O3|Outcome|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
469922|NCT00435162|O2|Outcome|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
469887|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469888|NCT00435188|O2|Outcome|Arm 2|Usual care
469889|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469890|NCT00435188|O2|Outcome|Arm 2|Usual care
469891|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469892|NCT00435188|O2|Outcome|Arm 2|Usual care
469893|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469894|NCT00435188|O2|Outcome|Arm 2|Usual care
469895|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469896|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
469897|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469898|NCT00435188|O2|Outcome|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
469899|NCT00435188|O1|Outcome|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469900|NCT00435188|O2|Outcome|Arm 2|Usual care
469901|NCT00435188|O1|Outcome|Arm 1|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469902|NCT00435188|E2|Reported Event|Arm 2, Usual Care|Usual care participants were asked to continue their normal activities and offered a 3-month physical activity counseling program upon completion of the trial
469903|NCT00435188|E1|Reported Event|Arm 1, Physical Activity Counseling|Multi-component physical activity counseling program: A one-year high intensity physical activity counseling program with the following five components: (1) a baseline face-to-face counseling session by the health counselor, (2) follow-up telephone calls by the health counselor biweekly for 6 weekly and then monthly, (3) a one-time physician endorsement of the prescribed exercise regimen in a primary care clinic visit, (4) monthly automated tailored telephone calls from the primary care provider encouraging continued physical activity, and (5) quarterly mailed materials providing personalized feedback
469904|NCT00435162|B4|Baseline|Total|Total of all reporting groups
469905|NCT00435162|B3|Baseline|High Dose|Extemporaneous suspension of valsartan 4.0 mg/kg, taken once daily
469906|NCT00435162|B2|Baseline|Medium Dose|Extemporaneous suspension of valsartan 1.0 mg/kg, taken once daily
469907|NCT00435162|B1|Baseline|Low Dose|Extemporaneous suspension of valsartan 0.25 mg/kg, taken once daily
469908|NCT00435162|P6|Participant Flow|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then placebo
469909|NCT00435162|P5|Participant Flow|High Dose in Both Periods|Valsartan 1.0 mg/kg, then placebo
469924|NCT00435162|E6|Reported Event|High Dose, Then Placebo|Valsartan 4.0 mg/kg, then Placebo
469925|NCT00435162|E5|Reported Event|High Dose in Both Periods|Valsartan 4.0 mg/kg in both periods
469926|NCT00435162|E4|Reported Event|Medium Dose, Then Placebo|Valsartan 1.0 mg/kg, then Placebo
469927|NCT00435162|E3|Reported Event|Medium Dose in Both Periods|Valsartan 1.0 mg/kg in both periods
469928|NCT00435162|E2|Reported Event|Low Dose, Then Placebo|Valsartan 0.25 mg/kg, then Placebo
469929|NCT00435162|E1|Reported Event|Low Dose in Both Periods|Valsartan 0.25 mg/kg in both periods
469930|NCT00435045|B3|Baseline|Total|Total of all reporting groups
469931|NCT00435045|B2|Baseline|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469932|NCT00435045|B1|Baseline|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469933|NCT00435045|P2|Participant Flow|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469934|NCT00435045|P1|Participant Flow|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469935|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469936|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469937|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469938|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469939|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469940|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469941|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469942|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469943|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469944|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469945|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469946|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469947|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469948|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469949|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469950|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469951|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469952|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469953|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469954|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469955|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469956|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469957|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469958|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469959|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469960|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469961|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469962|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469963|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469964|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469965|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469966|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469967|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469968|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469969|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469970|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469971|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469972|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
470001|NCT00434993|B2|Baseline|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
469973|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469974|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469975|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469976|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469977|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469978|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469979|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469980|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469981|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469982|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469983|NCT00435045|O2|Outcome|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469984|NCT00435045|O1|Outcome|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469985|NCT00435045|E2|Reported Event|Placebo + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive Placebo + Atorvastatin 10 mgs for 8 weeks, then Placebo + Atorvastatin 20 mgs for 4 weeks, then Placebo + Atorvastatin 40 mgs for 4 additional weeks.
469986|NCT00435045|E1|Reported Event|Lovaza(Omacor) + Atorvastatin|Subjects who met all study requirements after screening visit and who were randomized to receive 4 gms Lovaza (Omega-3-acid ethyl esters) + Atorvastatin 10 mgs for 8 weeks, then 4 gms Lovaza + Atorvastatin 20 mgs for 4 weeks, then 4 gms Lovaza + Atorvastatin 40 mgs for 4 additional weeks.
469987|NCT00435019|B3|Baseline|Total|Total of all reporting groups
469988|NCT00435019|B2|Baseline|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469989|NCT00435019|B1|Baseline|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469990|NCT00435019|P2|Participant Flow|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469991|NCT00435019|P1|Participant Flow|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469992|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469993|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469994|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469995|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469996|NCT00435019|O2|Outcome|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469997|NCT00435019|O1|Outcome|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469998|NCT00435019|E2|Reported Event|NPH Insulin|Individually adjusted NPH insulin dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
469999|NCT00435019|E1|Reported Event|Insulin Detemir|Individually adjusted insulin detemir dose injected subcutaneously once daily (evening) or twice daily (morning and evening) + insulin aspart with larger meals
470000|NCT00434993|B3|Baseline|Total|Total of all reporting groups
470002|NCT00434993|B1|Baseline|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470003|NCT00434993|P2|Participant Flow|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470004|NCT00434993|P1|Participant Flow|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470005|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470006|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470007|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470008|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470009|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470010|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470011|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470012|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470013|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470014|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470015|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470016|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470017|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470018|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470019|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470020|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470021|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470022|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470023|NCT00434993|O2|Outcome|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470024|NCT00434993|O1|Outcome|Albuterol|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470025|NCT00434993|E2|Reported Event|Placebo|Preservative-free 0.9% sterile sodium chloride every 4 hours
470026|NCT00434993|E1|Reported Event|Albuterol Sulfate|Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours
470027|NCT00434967|B5|Baseline|Total|Total of all reporting groups
470028|NCT00434967|B4|Baseline|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470029|NCT00434967|B3|Baseline|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470030|NCT00434967|B2|Baseline|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470031|NCT00434967|B1|Baseline|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470032|NCT00434967|P4|Participant Flow|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470033|NCT00434967|P3|Participant Flow|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470034|NCT00434967|P2|Participant Flow|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470035|NCT00434967|P1|Participant Flow|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470036|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470037|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470038|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470039|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470040|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470041|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470076|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470042|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470043|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470044|NCT00434967|O4|Outcome|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470045|NCT00434967|O3|Outcome|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470046|NCT00434967|O2|Outcome|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470047|NCT00434967|O1|Outcome|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470048|NCT00434967|E4|Reported Event|Candesartan/HCT 32/25 mg|candesartan/HCT 32/25 mg (given as 2 candesartan/HCT 16/12.5 mg tablets, plus 1 placebo tablet corresponding to candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470049|NCT00434967|E3|Reported Event|HCT 25 mg|HCT 25 mg (given as 2 HCT 12.5 mg tablets plus 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets and 1 placebo tablet corresponding to a candesartan 32 mg tablet for double dummy blinding purpose)
470050|NCT00434967|E2|Reported Event|Candesartan 32 mg|candesartan 32 mg (given as 1 candesartan 32 mg tablet plus 2 placebo tablets corresponding to candesartan/Hydrochlorothiazide (HCT) 16/12.5 mg tablets and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purposes)
470051|NCT00434967|E1|Reported Event|Placebo|given as 2 placebo tablets corresponding to candesartan/HCT 16/12.5 mg tablets, 1 placebo tablet corresponding to a candesartan 32 mg tablet and 2 placebo tablets corresponding to HCT 12.5 mg tablets for double dummy blinding purpose)
470052|NCT00434954|B3|Baseline|Total|Total of all reporting groups
470053|NCT00434954|B2|Baseline|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470054|NCT00434954|B1|Baseline|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470055|NCT00434954|P2|Participant Flow|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470056|NCT00434954|P1|Participant Flow|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470057|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470058|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470059|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470060|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470061|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470062|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470063|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470064|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470065|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470066|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470067|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470068|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470069|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470070|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470071|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470072|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470073|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470074|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470075|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470077|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470078|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470079|NCT00434954|O2|Outcome|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470080|NCT00434954|O1|Outcome|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470081|NCT00434954|E2|Reported Event|Premixed Insulin Aspart Twice Daily|Premixed insulin aspart (70% protamin crystallized, 30% soluble) twice daily, individually titrated to reach target blood glucose levels for 26 weeks
470082|NCT00434954|E1|Reported Event|Exenatide Twice Daily|Exenatide 5 mcg twice daily for 4 weeks, followed by 10 mcg twice daily for 26 weeks
470083|NCT00434876|B3|Baseline|Total|Total of all reporting groups
470084|NCT00434876|B2|Baseline|Placebo|Placebo
470085|NCT00434876|B1|Baseline|Quetiapine|Quetiapine XR
470086|NCT00434876|P2|Participant Flow|Placebo|The matching placebo pills were similarly taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
470087|NCT00434876|P1|Participant Flow|Quetiapine XR|The pills were taken at bedtime and the dose was titrated flexibly in the following fashion over the first week: 50 mg dose for 2 nights, followed by 200 mg a night for 2 nights, and then 300 mg a night for 2 nights and to a final dose of 400 mg daily starting on night # 7. Medication taper commenced at week 8 in the reverse stepwise fashion after the second set of two polysomnograms.
470088|NCT00434876|O2|Outcome|Placebo|Placebo
470089|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
470090|NCT00434876|O2|Outcome|Placebo|Placebo
470091|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
470092|NCT00434876|O2|Outcome|Placebo|Placebo
470093|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
470094|NCT00434876|O2|Outcome|Placebo|Placebo
470095|NCT00434876|O1|Outcome|Quetiapine XR|Quetiapine XR
470096|NCT00434876|E2|Reported Event|Placebo|Placebo
470097|NCT00434876|E1|Reported Event|Quetiapine|Quetiapine XR
470098|NCT00434759|B3|Baseline|Total|Total of all reporting groups
470099|NCT00434759|B2|Baseline|Standardtherapy|standard therapy (therapist-guided intervention only)
470100|NCT00434759|B1|Baseline|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470101|NCT00434759|P2|Participant Flow|Standardtherapy|standard therapy (therapist-guided intervention only)
470102|NCT00434759|P1|Participant Flow|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470103|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
470104|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470105|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
470106|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470107|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
470108|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470109|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only)
470110|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470111|NCT00434759|O2|Outcome|Standardtherapy|standard therapy (therapist-guided intervention only; 16 sessions)
470112|NCT00434759|O1|Outcome|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission (8 sessions up to 24 sessions)
470113|NCT00434759|E2|Reported Event|Standardtherapy|standard therapy (therapist-guided intervention only)
470114|NCT00434759|E1|Reported Event|Stepped Care Program|stepped-care program with self-help module with minimal therapist contact as first step, followed by therapist-guided intervention depending on status of remission
470115|NCT00434642|B3|Baseline|Total|Total of all reporting groups
470116|NCT00434642|B2|Baseline|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
470117|NCT00434642|B1|Baseline|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470298|NCT00434226|P1|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470118|NCT00434642|P2|Participant Flow|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
470119|NCT00434642|P1|Participant Flow|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470120|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470121|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470122|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470123|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470124|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470125|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470126|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470127|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470128|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470129|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470130|NCT00434642|O2|Outcome|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470299|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470131|NCT00434642|O1|Outcome|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient's weight at baseline and remained the same throughout the study.
470132|NCT00434642|E2|Reported Event|Carboplatin and Gemcitabine + Placebo|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Placebo was administered by IV on Day 1 of each of the six 21-day treatment cycles.
470133|NCT00434642|E1|Reported Event|Carboplatin and Gemcitabine + Bevacizumab|Carboplatin (AUC 4 mg/mL/minute) was administered intravenously (IV) on Day 1 of each of six 21-day treatment cycles. The carboplatin dose was calculated to reach a target area under the curve (AUC) of concentration x time according to the Calvert formula. Gemcitabine 1000 mg/m^2 was administered IV on Days 1 and Day 8 of each of the six 21-day treatment cycles. Bevacizumab 15 mg/kg was administered IV on Day 1 of each of the six 21-day treatment cycles. The bevacizumab dose was based on the patient’s weight at baseline and remained the same throughout the study.
470134|NCT00434590|B3|Baseline|Total|Total of all reporting groups
470135|NCT00434590|B2|Baseline|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
470136|NCT00434590|B1|Baseline|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
470137|NCT00434590|P2|Participant Flow|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
470138|NCT00434590|P1|Participant Flow|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
470139|NCT00434590|O2|Outcome|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
470140|NCT00434590|O1|Outcome|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
470141|NCT00434590|E2|Reported Event|Standard Dose of Myfortic® and Standard Dose of CsA-ME|Patients received unchanged dose of Myfortic® (equimolar to the prior established dose MMF) and unchanged standard dose of CsA-ME.
470142|NCT00434590|E1|Reported Event|Full Dose Myfortic® and Reduced Dose Neoral®|The administration of gradual dose increased to reach 1440 mg/day (V4) of enteric-coated mycophenolate sodium (Myfortic®, EC-MPS) with simultaneous dose reduction of micro emulsion cyclosporine (Neoral®, CsA-ME) given to maintenance kidney transplant patients previously treated with reduced-dose mycophenolate mofetil (MMF) and standard dose CsA-ME
470143|NCT00434434|B4|Baseline|Total|Total of all reporting groups
470144|NCT00434434|B3|Baseline|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470145|NCT00434434|B2|Baseline|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470146|NCT00434434|B1|Baseline|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470147|NCT00434434|P3|Participant Flow|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470148|NCT00434434|P2|Participant Flow|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470149|NCT00434434|P1|Participant Flow|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470150|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470151|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470152|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470153|NCT00434434|O3|Outcome|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470154|NCT00434434|O2|Outcome|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470155|NCT00434434|O1|Outcome|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470156|NCT00434434|E3|Reported Event|Placebo|Lyophilized placebo subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470157|NCT00434434|E2|Reported Event|Lyopholized Omalizumab|Lyophilized omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470158|NCT00434434|E1|Reported Event|Liquid Omalizumab|Liquid omalizumab subcutaneously either every 2 weeks or every 4 weeks based on their weight and IgE levels at screening
470337|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
470159|NCT00434421|B1|Baseline|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
470160|NCT00434421|P1|Participant Flow|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
470161|NCT00434421|O1|Outcome|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
470162|NCT00434421|E1|Reported Event|German Cockroach Allergen Dosing Group|Initially each subject underwent a 1-day, 8-dose escalation (e.g., one dose of placebo, 0.14 milliliters [mL], followed by 7 escalating doses of Glycerinated German Cockroach Allergenic Extract until the Maximum Study Dose [0.42 mL, 1:10 wt/vol] or Maximum Tolerated Dose was achieved). This maximum dose became the daily dose - maintenance dose- of Glycerinated German Cockroach Allergenic Extract for the following 14 days.The maintenance dose of 0.42 mL was calculated to contain 3685 bioequivalent allergy units (BAU), with approximately 4.2 mg of German cockroach allergen Bla g 2 and 50 mg of Bla g 1 per dose. Route of administration: sublingual-oral route.
470163|NCT00434356|B3|Baseline|Total|Total of all reporting groups
470164|NCT00434356|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470165|NCT00434356|B1|Baseline|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470166|NCT00434356|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470167|NCT00434356|P1|Participant Flow|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470168|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470169|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470170|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470171|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470172|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470173|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470174|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470175|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470176|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470177|NCT00434356|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470338|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
470178|NCT00434356|O1|Outcome|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470179|NCT00434356|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest
470180|NCT00434356|E1|Reported Event|Bevacizumab + Paclitaxel + Sunitinib|Bevacizumab will be administered at 10 mg/kg by intravenous (IV) infusion every 2 weeks; paclitaxel will be administered at 90 mg/m2 by IV infusion weekly for 3 weeks followed by 1 week of rest; sunitinib will be administered orally at 25 mg/day or 37.5 mg/day for 3 weeks followed by 1 week of rest
470181|NCT00434330|B7|Baseline|Total|Total of all reporting groups
470182|NCT00434330|B6|Baseline|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470183|NCT00434330|B5|Baseline|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470184|NCT00434330|B4|Baseline|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470185|NCT00434330|B3|Baseline|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470186|NCT00434330|B2|Baseline|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470187|NCT00434330|B1|Baseline|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470188|NCT00434330|P6|Participant Flow|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470189|NCT00434330|P5|Participant Flow|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470190|NCT00434330|P4|Participant Flow|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470191|NCT00434330|P3|Participant Flow|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470192|NCT00434330|P2|Participant Flow|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470193|NCT00434330|P1|Participant Flow|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470194|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470195|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470272|NCT00434252|B2|Baseline|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470196|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470197|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470198|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470199|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470200|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470201|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470202|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470203|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470204|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470205|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470206|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470207|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470208|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470209|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470210|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470211|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470212|NCT00434330|O6|Outcome|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470339|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
470213|NCT00434330|O5|Outcome|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470214|NCT00434330|O4|Outcome|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470215|NCT00434330|O3|Outcome|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470216|NCT00434330|O2|Outcome|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470217|NCT00434330|O1|Outcome|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470218|NCT00434330|E6|Reported Event|Cohort 6, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470219|NCT00434330|E5|Reported Event|Cohort 5, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.04 mg/kg or 0.075 mg/kg for participants with an epoetin (alfa or beta) dose of ≤100 Units/kg/week or 100 to 150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470220|NCT00434330|E4|Reported Event|Cohort 4, Q4W, IV, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470221|NCT00434330|E3|Reported Event|Cohort 3, Q4W, SC, Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously once every 4 weeks for a total of 7 doses. With transition period between epoetin treatment and start of peginesatide treatment.
470222|NCT00434330|E2|Reported Event|Cohort 2, Q4W, IV, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 mg/kg for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered intravenously (IV) once every 4 weeks for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470223|NCT00434330|E1|Reported Event|Cohort 1, Q4W, SC, No Transition|Tiered peginesatide starting doses of 0.05, 0.075, or 0.1 milligram per kilogram (mg/kg) for participants on an epoetin (alfa or beta) dose of ≤100 Units/kg/week, >100 to 150 Units/kg/week, or >150 Units/kg/week, respectively. Doses were administered subcutaneously (SC) once every 4 weeks (Q4W) for a total of 7 doses. No transition period between epoetin treatment and start of peginesatide treatment.
470224|NCT00434304|B1|Baseline|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470225|NCT00434304|P1|Participant Flow|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470226|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470227|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470340|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
470228|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470229|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470230|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470231|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470232|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470233|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470234|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470235|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470236|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470237|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470238|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470273|NCT00434252|B1|Baseline|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470341|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
470239|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470240|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470241|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470242|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470243|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470244|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470245|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470246|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470247|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470248|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470249|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470274|NCT00434252|P2|Participant Flow|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470342|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470250|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470251|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470252|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470253|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470254|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470255|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470256|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470257|NCT00434304|O1|Outcome|Ropinirole PR/XR|Treatment Phase: Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 milligrams (mg) as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52. Taper phase: the dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470258|NCT00434304|E2|Reported Event|Ropinirole PR/XR (Taper Phase)|The dose was tapered over 2 to 3 weeks according to the maintenance dose at completion of the Treatment Phase (or withdrawal)
470259|NCT00434304|E1|Reported Event|Ropinirole PR/XR (Treatment Phase)|Fixed titration phase (4 weeks): one tablet of ropinirole PR/XR 2 mg as the initial dose. The dose was titrated weekly by 2 mg/day and was increased to 8 mg/day in Week 4; Flexible titration and maintenance dose phases (48 weeks): from Week 5 up to Week 16, the dose was increased at minimum intervals of 1 week between titration steps (up to 16 mg/day). From Week 16 onward, treatment dose was continuously administered up to Week 52.
470260|NCT00434278|B3|Baseline|Total|Total of all reporting groups
470261|NCT00434278|B2|Baseline|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470262|NCT00434278|B1|Baseline|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470263|NCT00434278|P2|Participant Flow|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470264|NCT00434278|P1|Participant Flow|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470265|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470266|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470267|NCT00434278|O2|Outcome|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470268|NCT00434278|O1|Outcome|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470269|NCT00434278|E2|Reported Event|Dornase Alfa|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470270|NCT00434278|E1|Reported Event|Placebo|2.5 mg inhalation dose twice daily for 14±2 days (Visit 2 to Visit 3)
470271|NCT00434252|B3|Baseline|Total|Total of all reporting groups
470297|NCT00434226|P2|Participant Flow|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470275|NCT00434252|P1|Participant Flow|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470276|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470277|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470278|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470279|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470280|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470281|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470282|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470283|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470284|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470285|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470286|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470287|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470288|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470289|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470290|NCT00434252|O2|Outcome|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470291|NCT00434252|O1|Outcome|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470292|NCT00434252|E2|Reported Event|Carboplatin+Paclitaxel+Bevacizumab|Administered by IV infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with bevacizumab.
470293|NCT00434252|E1|Reported Event|Carboplatin+Paclitaxel+Placebo|Administered by intravenous (IV) infusion every 3 weeks until disease progression, unacceptable toxicity, or for a maximum of 102 weeks, whichever occurred first. Carboplatin administration was stopped after completion of 10 treatment cycles, while paclitaxel continued to be administered with placebo.
470294|NCT00434226|B3|Baseline|Total|Total of all reporting groups
470295|NCT00434226|B2|Baseline|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470296|NCT00434226|B1|Baseline|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470300|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470301|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470302|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470303|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470304|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470305|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470306|NCT00434226|O2|Outcome|Bevacizumab + Carboplatin/Paclitaxel|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle and carboplatin/paclitaxel on the first day of each cycle for 4 cycles
470307|NCT00434226|O1|Outcome|Bevacizumab + Carboplatin/Paclitaxel + Sunitinib|Bevacizumab intravenously at a dose of 15mg/kg on the first day of each 21-day cycle, carboplatin/paclitaxel on the first day of each cycle for 4 cycles, and sunitinib 25 mg/day for 2 weeks, followed by 1 week of rest
470308|NCT00434213|B1|Baseline|Daytrana|Methylphenidate Transdermal System (MTS)
470309|NCT00434213|P1|Participant Flow|Daytrana|Methylphenidate Transdermal System (MTS)
470310|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
470311|NCT00434213|O1|Outcome|Daytrana|Methylphenidate Transdermal System (MTS)
470312|NCT00434213|E1|Reported Event|Daytrana|Methylphenidate Transdermal System (MTS)
470313|NCT00434161|B4|Baseline|Total|Total of all reporting groups
470314|NCT00434161|B3|Baseline|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470315|NCT00434161|B2|Baseline|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470316|NCT00434161|B1|Baseline|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
470317|NCT00434161|P3|Participant Flow|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy
470318|NCT00434161|P2|Participant Flow|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy (total of 6 doses). Daily dose of intravenous (IV) 60 µg/kg/day of placebo as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and on Days 0, 1 and 2 after high dose chemotherapy.
470319|NCT00434161|P1|Participant Flow|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). Daily dose of intravenous (IV) 60 µg/kg/day of palifermin as 1 bolus IV injection on Days -6, 5 and -4 before high dose chemotherapy and placebo on Days 0, 1 and 2 after high dose chemotherapy.
470320|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470321|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470322|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470323|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470324|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470325|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470326|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
470327|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470328|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470329|NCT00434161|O1|Outcome|Palifermin (Palifermin Before Only and, Before and After)|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses) AND Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470330|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
470331|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470332|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
470333|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
470334|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
470335|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only.
470336|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy.
470343|NCT00434161|O2|Outcome|Palifermin|Subjects to receive Before- and After chemotherapy, and Before chemotherapy only
470344|NCT00434161|O1|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470345|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470346|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470347|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
470348|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470349|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470350|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
470351|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses)
470352|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470353|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses)
470354|NCT00434161|O3|Outcome|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy
470355|NCT00434161|O2|Outcome|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470356|NCT00434161|O1|Outcome|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy and matched placebo after-high dose chemotherapy
470357|NCT00434161|E3|Reported Event|Palifermin Before and After|Subjects to receive palifermin before- and after-high dose chemotherapy (total of 6 doses). A total of 115 subjects were randomized to treatment and 113 received at least one dose of study treatment. Due to protocol deviations additional 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 109 subjects were included in this safety analysis set.
470358|NCT00434161|E2|Reported Event|Placebo|Subjects to receive matched placebo before- and after-high dose chemotherapy
470359|NCT00434161|E1|Reported Event|Palifermin Before Only|Subjects to receive palifermin before-high dose chemotherapy (total 3 doses) and matched placebo after-high dose chemotherapy (total 3 doses). A total of 109 subjects were randomized to treatment and 107 received at least one dose of study treatment. Due to protocol deviations 4 patients randomized to Palifermin Before and After group were included Palifermin Before Only group and therefore a total of 111 subjects were included in this safety analysis set.
470360|NCT00434148|B3|Baseline|Total|Total of all reporting groups
470361|NCT00434148|B2|Baseline|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470362|NCT00434148|B1|Baseline|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470363|NCT00434148|P2|Participant Flow|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470364|NCT00434148|P1|Participant Flow|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470365|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470366|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470475|NCT00433836|E2|Reported Event|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470367|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470368|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470369|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470370|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470371|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470372|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470373|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470374|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470375|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470376|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470377|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470405|NCT00434122|O2|Outcome|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
470378|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470379|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470380|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470381|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470382|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470383|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470384|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470385|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470386|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470387|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470388|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470406|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
470476|NCT00433836|E1|Reported Event|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470389|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470390|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470391|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470392|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470393|NCT00434148|O2|Outcome|Pasireotide 900 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470394|NCT00434148|O1|Outcome|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotide was available commercially in their country.
470395|NCT00434148|E2|Reported Event|Pasireotide 900 ug|At randomization, participants received 900 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 1200 ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470396|NCT00434148|E1|Reported Event|Pasireotide 600 ug|At randomization, participants received 600 ug subcutaneously (sc) twice daily (bid). Participants continued at this dose until month 6 if their month 3 mean urinary free cortisol (mUFC) was <= 2 x the upper limit of normal (ULN) and the mUFC was below or equal to their baseline mUFC. Participants not meeting the mUFC criteria at month 3 were unblinded and required to increase their dose to 900ug bid on an open label basis. Participants had the option to continue in the extension phase as long as they did not meet any discontinuation criteria or until pasireotode was available commercially in their country.
470397|NCT00434122|B3|Baseline|Total|Total of all reporting groups
470398|NCT00434122|B2|Baseline|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
470399|NCT00434122|B1|Baseline|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
470400|NCT00434122|P2|Participant Flow|Placebo|"Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6.~or Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day."
470401|NCT00434122|P1|Participant Flow|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
470402|NCT00434122|O3|Outcome|Ganirelix, 0.25 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
470403|NCT00434122|O2|Outcome|Degarelix Follicular, 2.5 mg|Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6
470404|NCT00434122|O1|Outcome|Degarelix Mid-luteal, 2.5 mg|Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.
470473|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470407|NCT00434122|E2|Reported Event|Ganirelix, 0.25 mg|Placebo will be injected SC 7 days after LH peak and on Stimulation Day 1. Ganirelix 0.25 mg will be injected SC daily from Stimulation Day 6 until the last stimulation day.
470408|NCT00434122|E1|Reported Event|Degarelix, 2.5 mg|"Combination of these two groups: Degarelix Mid-luteal 2.5 mg and Degarelix Follicular 2.5 mg.~Degarelix Mid-luteal, 2.5 mg: Degarelix 2.5 mg will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak and on Stimulation Day 6. Placebo will be injected SC on Stimulation Day 1.~Degarelix Follicular, 2.5 mg: Placebo will be injected subcutaneously (SC) 7 days after luteinizing hormone (LH) peak. Degarelix 2.5 mg will be injected SC on Stimulation Day 1 and Stimulation Day 6."
470409|NCT00434109|B1|Baseline|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470410|NCT00434109|P1|Participant Flow|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470411|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470412|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470413|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470414|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470415|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470416|NCT00434109|O1|Outcome|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470417|NCT00434109|E1|Reported Event|Sunitinib Malate and Hepatic Artery Embolizations|Sunitinib Malate and Selective Hepatic Artery Embolizations: Sunitinib malate (Sutent) at a dose of 37.5mg. 1-3 selective hepatic artery embolizations.
470418|NCT00434057|B1|Baseline|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
470419|NCT00434057|P1|Participant Flow|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
470420|NCT00434057|O1|Outcome|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
470421|NCT00434057|E1|Reported Event|Biopsied Pigmented Skin Lesions|Lesions for which clinical management was prospectively determined to be biopsy of the lesion in toto
470422|NCT00434018|B3|Baseline|Total|Total of all reporting groups
470423|NCT00434018|B2|Baseline|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470424|NCT00434018|B1|Baseline|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470425|NCT00434018|P2|Participant Flow|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470426|NCT00434018|P1|Participant Flow|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470427|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470428|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470429|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470430|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470431|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470432|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470433|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470474|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470434|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470435|NCT00434018|O2|Outcome|Basic Health Training|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470436|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470437|NCT00434018|O2|Outcome|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470438|NCT00434018|O1|Outcome|Wheelchair Skills Training Program|Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs. The WSP is a set of assessment and training protocols related to wheelchair skills. The WSP includes the Wheelchair Skills Test (WST), the Wheelchair Skills Training Program (WSTP) and related materials.
470439|NCT00434018|E2|Reported Event|Basic Health Education|Basic health educational training sessions: Five sessions are held with subjects to provide them additional information regarding health related issues - such as nutrition, proper hand hygiene, sports, etc
470440|NCT00434018|E1|Reported Event|Wheelchair Skills Training|Wheelchair Skills Training: Subjects are provided with five weeks of wheelchair skills training, tailored to meet their needs.
470441|NCT00433914|B3|Baseline|Total|Total of all reporting groups
470442|NCT00433914|B2|Baseline|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470443|NCT00433914|B1|Baseline|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470444|NCT00433914|P2|Participant Flow|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470445|NCT00433914|P1|Participant Flow|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470446|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470447|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470448|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470449|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470450|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470451|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470452|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470453|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470454|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470455|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470456|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470457|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470458|NCT00433914|O2|Outcome|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470459|NCT00433914|O1|Outcome|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470460|NCT00433914|E2|Reported Event|rMenB+OMV|6-8 month-old infants received 3 doses of rMenB vaccine with OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470461|NCT00433914|E1|Reported Event|rMenB|6-8 month-old infants received 3 doses of rMenB vaccine without OMV-NZ at 6-8 months of age, 2 months later and at 12 months of age.
470462|NCT00433836|B3|Baseline|Total|Total of all reporting groups
470463|NCT00433836|B2|Baseline|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470464|NCT00433836|B1|Baseline|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470465|NCT00433836|P2|Participant Flow|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470466|NCT00433836|P1|Participant Flow|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470467|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470468|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470469|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470470|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470471|NCT00433836|O2|Outcome|Enalapril|Weight stratified dosages given by mouth, once daily, of enalapril 10/20/40 mg.
470472|NCT00433836|O1|Outcome|Valsartan|Weight stratified dosages given by mouth, once daily, of valsartan 80/160/320 mg.
470477|NCT00433771|B1|Baseline|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470478|NCT00433771|P1|Participant Flow|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470479|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470480|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470481|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470482|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470483|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470484|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470485|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470486|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470487|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470488|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470489|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470490|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470491|NCT00433771|O1|Outcome|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470492|NCT00433771|E1|Reported Event|WallFlex Biliary Fully Covered Stent|Single arm, biliary stenting, using WallFlex Biliary Fully Covered stent
470493|NCT00433745|B1|Baseline|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
470494|NCT00433745|P1|Participant Flow|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
470495|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|"All 4 patients who were accrued went on to receive the vaccine.~Complete Response (CR): defined as an absolute neutrophil count of ≥500/µL, platelet count of ≥75,000/µL, no leukemic blasts in the blood nor evidence of extramedullary leukemia, bone marrow (BM) with a cellularity of more than 20%, maturation of all three cell lineages, no Auer rods, and less than 5% bone marrow blast cells.~Partial response (PR): 50% reduction in marrow blasts, with an absolute neutrophil count (ANC) greater than 500/µL, and platelet count greater than 75000/µL.~No response: subjects who did not meet the above response criteria were defined as non-responders."
470496|NCT00433745|O1|Outcome|WT1 Peptide Vaccine|Subjects with hematologic malignancies will receive WT1 peptide vaccine to evaluate if the intervention will stimulate a protective immune response.
470497|NCT00433745|E1|Reported Event|WT1 Peptide Vaccine|All 4 patients who were accrued went on to receive the vaccine
470498|NCT00433654|B3|Baseline|Total|Total of all reporting groups
470499|NCT00433654|B2|Baseline|Control Group|The control group waited for one hour (did not have an MRI scan) at 9-12 weeks post-implant.
470500|NCT00433654|B1|Baseline|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470501|NCT00433654|P2|Participant Flow|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
470502|NCT00433654|P1|Participant Flow|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470503|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
470504|NCT00433654|O1|Outcome|5086 MRI Lead|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470505|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
470506|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470507|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
470508|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470509|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
470510|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470511|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
470512|NCT00433654|O1|Outcome|5086 MRI Lead|The 5086 MRI lead was used by all subjects in this study
470513|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
470514|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470515|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
470516|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470517|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470518|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470519|NCT00433654|O1|Outcome|Implanted Subjects|All subjects undergoing an implant attempt
470520|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
470521|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470522|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at the 9-12 week follow-up.
470523|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470524|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
470525|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470526|NCT00433654|O2|Outcome|Control Group|The control group waited for one hour (no MRI) at the 9-12 week follow-up.
470527|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470528|NCT00433654|O1|Outcome|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470529|NCT00433654|E3|Reported Event|Non-randomized|Some subjects were enrolled, but either did not receive a system, or received only a partial system, and were not randomized. Their adverse events were collected until they exited the study.
470530|NCT00433654|E2|Reported Event|Control Group|The control group waited for one hour (no MRI scan) at 9-12 weeks post-implant
470531|NCT00433654|E1|Reported Event|MRI Group|The MRI group underwent a one-hour MRI scan at 9-12 weeks post-implant.
470532|NCT00433537|B1|Baseline|Step 1 - VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
470533|NCT00433537|P3|Participant Flow|VcR-CVAD Induction Then Off Study|Patients received VcR-CVAD induction but did not proceed to step 2 treatment for various reasons.
470534|NCT00433537|P2|Participant Flow|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
470535|NCT00433537|P1|Participant Flow|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) subcutaneous (SC) or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
470536|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
470537|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
470538|NCT00433537|O2|Outcome|VcR-CVAD Induction Followed by ASCT|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~ASCT: After completion of induction therapy, patients who are eligible may have the option to receive consolidation therapy for autologous stem cell transplantation (off-study). These patients undergo stem cell harvest during courses 4, 5, or 6 of induction therapy."
470539|NCT00433537|O1|Outcome|VcR-CVAD Induction Followed by Maintenance Rituximab|"VcR-CVAD induction: Patients receive VcR-CVAD comprising bortezomib IV over 3-5 seconds on days 1 and 4; rituximab IV over 3-4 hours on day 1; doxorubicin hydrochloride IV over 48 hours on days 1 and 2; cyclophosphamide IV over 3 hours every 12 hours on days 1-3; vincristine IV over 3-5 seconds on day 3; and dexamethasone IV or orally once daily on days 1-4. Patients also receive filgrastim (G-CSF) SC or IV once daily beginning on day 5 or 6 and continuing until blood counts recover OR pegfilgrastim SC on day 5 or 6. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Maintenance rituximab: Beginning 4-8 weeks after completion of induction therapy, patients receive rituximab IV over 3-4 hours once weekly for 4 weeks. Treatment repeats every 6 months for up to 4 courses in the absence of disease progression or unacceptable toxicity."
470540|NCT00433537|O1|Outcome|VcR-CVAD Induction|All eligible patients who received VcR-CVAD induction.
470541|NCT00433537|E2|Reported Event|Step 2 - Maintenance Rituximab|All patients who received maintenance rituximab.
470542|NCT00433537|E1|Reported Event|Step 1 - VcR-CVAD Induction|All patients who received VcR-CVAD induction.
470543|NCT00433446|B1|Baseline|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470544|NCT00433446|P1|Participant Flow|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470545|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470546|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470547|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470548|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470549|NCT00433446|O1|Outcome|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470550|NCT00433446|E1|Reported Event|CNTO 328|CNTO 328 will be given 6 mg/kg through intravenous (IV) once per cycle ( 1 cycle= 14 days) for 12 cycles
470551|NCT00433381|B3|Baseline|Total|Total of all reporting groups
470552|NCT00433381|B2|Baseline|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
470553|NCT00433381|B1|Baseline|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
470554|NCT00433381|P2|Participant Flow|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
470555|NCT00433381|P1|Participant Flow|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
470556|NCT00433381|O1|Outcome|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor.
470557|NCT00433381|O1|Outcome|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as definted by stable or responding tumor.
470558|NCT00433381|E2|Reported Event|Arm II (Bevacizumab and Irinotecan Hydrochloride)|Patients receive bevacizumab IV as in Arm I followed by irinotecan hydrochloride IV over 90 minutes on days 1 and 15 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 57 patients.
470559|NCT00433381|E1|Reported Event|Arm I (Bevacizumab and Temozolomide)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral temozolomide once daily on days 1-21 of a 28-day cycle. Up to 24 cycles for patients demonstrating evidence of benefit as defined by stable or responding tumor. Data is reported for eligible patients with adverse event data who started study treatment, which is 60.
470560|NCT00433329|B1|Baseline|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
470561|NCT00433329|P1|Participant Flow|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
470562|NCT00433329|O1|Outcome|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
470563|NCT00433329|E1|Reported Event|Bosentan/Sildenafil|Oral bosentan 62.5 mg twice daily (BID) for 4 week followed by 24 weeks of 125 mg BID with the addition of sildenafil 20 mg thrice daily (TID) in patients who do not reach the 6-MWT distance threshold at Week 16
470564|NCT00433290|B3|Baseline|Total|Total of all reporting groups
470565|NCT00433290|B2|Baseline|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470566|NCT00433290|B1|Baseline|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470567|NCT00433290|P2|Participant Flow|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470568|NCT00433290|P1|Participant Flow|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470569|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470570|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470571|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470572|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470573|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470574|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470575|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470576|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470577|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470578|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470579|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470580|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470581|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470582|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470583|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470584|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470585|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470586|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470587|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470588|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470589|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470590|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470591|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470592|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470593|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470594|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470595|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470596|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470597|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470598|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470599|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470600|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470601|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470602|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470603|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470604|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470605|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470606|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470607|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470608|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470609|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470610|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470611|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470612|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470649|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470613|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470614|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470615|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470616|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470617|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470618|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470619|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470620|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470621|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470622|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470623|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470624|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470625|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470626|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470627|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470628|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470629|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470630|NCT00433290|O2|Outcome|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470631|NCT00433290|O1|Outcome|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470632|NCT00433290|E2|Reported Event|Placebo|placebo every day (QD), by mouth (PO) for 13 weeks
470633|NCT00433290|E1|Reported Event|Duloxetine|duloxetine 30 mg every day (QD), by mouth (PO) for 1 week, then duloxetine 60 mg QD, PO for 6 weeks, followed by duloxetine 60 mg QD, PO for 6 weeks for responders or duloxetine 120 mg QD, PO for 6 weeks for non-responders
470634|NCT00432237|B5|Baseline|Total|Total of all reporting groups
470635|NCT00432237|B4|Baseline|Placebo|"Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
470636|NCT00432237|B3|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
470637|NCT00432237|B2|Baseline|MK0974 150 mg|"MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
470638|NCT00432237|B1|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack~The reported number of participants are all patients randomized who received study drug and completed the study."
470639|NCT00432237|P4|Participant Flow|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470640|NCT00432237|P3|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470641|NCT00432237|P2|Participant Flow|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470642|NCT00432237|P1|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470643|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470644|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470645|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470646|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470647|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470648|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470650|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470651|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470652|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470653|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470654|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470655|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470656|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470657|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470658|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470659|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470660|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470661|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470662|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470663|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470664|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470665|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470666|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470667|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470668|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470669|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470670|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470671|NCT00432237|O4|Outcome|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470672|NCT00432237|O3|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470673|NCT00432237|O2|Outcome|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470674|NCT00432237|O1|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470675|NCT00432237|E4|Reported Event|Placebo|Placebo; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine attack
470676|NCT00432237|E3|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (MK0974 300 mg or placebo) to treat a single moderate-to-severe migraine attack
470677|NCT00432237|E2|Reported Event|MK0974 150 mg|MK0974 150 mg; one orally-administered dose, plus an optional second dose (MK0974 150 mg) to treat a single moderate-to-severe migraine attack
470678|NCT00432237|E1|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (MK0974 50 mg) to treat a single moderate-to-severe migraine attack
470679|NCT00431184|B3|Baseline|Total|Total of all reporting groups
470680|NCT00431184|B2|Baseline|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
470681|NCT00431184|B1|Baseline|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
470682|NCT00431184|P2|Participant Flow|Lorazepam Then Pentazocine|In the first leg of the study, lorazepam will be given to subjects randomly assigned to this group. On Day 3, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later. On Day 2, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later.
470683|NCT00431184|P1|Participant Flow|Pentazocine Then Lorazepam|In the first leg of the study, pentazocine will be given to subjects randomly assigned to this group. On Day 1, subjects will receive 50mg of pentazocine followed by a second dose of 50mg two hours later. On Day 2, subjects in this group will be given 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later.
490989|NCT00381303|O3|Outcome|Hispanic|
470684|NCT00431184|O2|Outcome|Lorazepam|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Lorazepam.
470685|NCT00431184|O1|Outcome|Pentazocine|The results below represent the mean change in YMRS scores for all 19 subjects following administration of Pentazocine.
470686|NCT00431184|O2|Outcome|Lorazepam|Subjects received 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later
470687|NCT00431184|O1|Outcome|Pentazocine|Subjects received 50mg of pentazocine
470688|NCT00431184|E2|Reported Event|Lorazepam|All subjects receive 0.25mg of Lorazepam followed by a second dose of 0.25mg two hours later on either Day 1 or Day 2.
470689|NCT00431184|E1|Reported Event|Pentazocine|All subjects receive 50mg of pentazocine followed by a second dose of 50mg two hours later on either Day 1 or Day 2.
470690|NCT00431132|B1|Baseline|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
470691|NCT00431132|P1|Participant Flow|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
470692|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
470693|NCT00431132|O1|Outcome|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
470694|NCT00431132|E1|Reported Event|Vagifem® 10 mcg|One 10 mcg (microgram) vaginal tablet of intravaginal estradiol (Vagifem®) once daily for two weeks followed by one 10 mcg vaginal tablet twice weekly for 50 weeks
470695|NCT00431067|B1|Baseline|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470696|NCT00431067|P1|Participant Flow|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470697|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470698|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470699|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470700|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470701|NCT00431067|O1|Outcome|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470702|NCT00431067|E1|Reported Event|Afatinib 50 mg|Patients received continuous daily dosing with Afatinib 50 mg therapy over 28-day treatment cycles until further disease progression or undue toxicity.
470703|NCT00431041|B3|Baseline|Total|Total of all reporting groups
470704|NCT00431041|B2|Baseline|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470705|NCT00431041|B1|Baseline|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470706|NCT00431041|P2|Participant Flow|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470707|NCT00431041|P1|Participant Flow|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470708|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470709|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470710|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470711|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470712|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470713|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470714|NCT00431041|O2|Outcome|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470715|NCT00431041|O1|Outcome|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470716|NCT00431041|E2|Reported Event|Oxybutynin IR|Oxybutynin Immediate Release: 5 mg capsules, taken orally, 3 times a day
470717|NCT00431041|E1|Reported Event|Solifenacin|Solifenacin succinate: 5 mg tablets, taken orally, once daily
470718|NCT00433199|B3|Baseline|Total|Total of all reporting groups
470719|NCT00433199|B2|Baseline|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
470720|NCT00433199|B1|Baseline|Placebo|Placebo comparator administered during the Double-Blind period only
470721|NCT00433199|P2|Participant Flow|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
470722|NCT00433199|P1|Participant Flow|Placebo|Placebo comparator administered during the Double-Blind period only
470723|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
470724|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
470725|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-blind period and Testosterone gel 1.62% given during the Open-label period.
470726|NCT00433199|O3|Outcome|Combined (CA and FP)|Testosterone gel 1.62% is given to all the subjects entering the Open-label period.
470727|NCT00433199|O2|Outcome|Formerly Placebo (FP)|Placebo group given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
470728|NCT00433199|O1|Outcome|Continuing Active T-Gel 1.62% (CA)|Testosterone gel 1.62% given during the Double-Blind period and Testosterone gel 1.62% given during the Open-label period.
470729|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
470730|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
470731|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
470732|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
470733|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
470734|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
470735|NCT00433199|O2|Outcome|Placebo|Placebo Comparator given during the double-blind period.
470736|NCT00433199|O1|Outcome|T-Gel 1.62%|Testosterone gel 1.62% given during the double-blind period.
470737|NCT00433199|E2|Reported Event|T-Gel 1.62%|Testosterone (T): daily dose of 2.50 g testosterone gel 1.62% administered during the Double-Blind period and the Open-Label period.
470738|NCT00433199|E1|Reported Event|Placebo|Placebo comparator administered during the Double-Blind period only
470739|NCT00433160|B3|Baseline|Total|Total of all reporting groups
470740|NCT00433160|B2|Baseline|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470741|NCT00433160|B1|Baseline|Teriparatide|20 micrograms for 104 weeks
470742|NCT00433160|P2|Participant Flow|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470743|NCT00433160|P1|Participant Flow|Teriparatide|20 micrograms for 104 weeks
470744|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470745|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470746|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470747|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470748|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470749|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470750|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470751|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470752|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470753|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470754|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470755|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470756|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470757|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470758|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470759|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470760|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470761|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470762|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470763|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470764|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470765|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470766|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470767|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470768|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470769|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470770|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470771|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470772|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470773|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470774|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470775|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470776|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470777|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470778|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470779|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470780|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470781|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470782|NCT00433160|O2|Outcome|Placebo|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470783|NCT00433160|O1|Outcome|Teriparatide|20 micrograms for 104 weeks
470784|NCT00433160|E6|Reported Event|Placebo (During 104 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470785|NCT00433160|E5|Reported Event|Teriparatide (During 104 Weeks)|20 micrograms for 104 weeks
470854|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470786|NCT00433160|E4|Reported Event|Placebo (During 76 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470787|NCT00433160|E3|Reported Event|Teriparatide (During 76 Weeks)|20 micrograms for 104 weeks
470788|NCT00433160|E2|Reported Event|Placebo (During 52 Weeks)|Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
470789|NCT00433160|E1|Reported Event|Teriparatide (During 52 Weeks)|20 micrograms for 104 weeks
470790|NCT00433017|B3|Baseline|Total|Total of all reporting groups
470791|NCT00433017|B2|Baseline|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470792|NCT00433017|B1|Baseline|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470793|NCT00433017|P2|Participant Flow|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470794|NCT00433017|P1|Participant Flow|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470795|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470796|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470797|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470798|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470799|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
471117|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
490990|NCT00381303|O2|Outcome|Caucasian|
470800|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470801|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470802|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470803|NCT00433017|O2|Outcome|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470804|NCT00433017|O1|Outcome|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470805|NCT00433017|E2|Reported Event|Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1 and then as needed from Month 3 based on the retreatment criteria. These patients were also administered verteporfin placebo infusion with sham PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470806|NCT00433017|E1|Reported Event|Verteporfin + Ranibizumab|Patients received three consecutive monthly ranibizumab injections starting on Day 1, and then as needed at intervals of at least 30 days based on retreatment criteria. These patients also received verteporfin PDT on Day 1 and then as needed from Month 3 at intervals of at least 90 days based on the retreatment criteria. From month 3 onward, retreatments were determined based on study-specific retreatment criteria that included retinal thickness by Optical Coherence Tomography (OCT), sub-retinal hemorrhage evaluated by ophthalmoscopic examination, visual acuity assessed using Early treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart and CNV leakage assessed by fluorescein angiography (FA).
470807|NCT00432835|B3|Baseline|Total|Total of all reporting groups
470808|NCT00432835|B2|Baseline|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
470809|NCT00432835|B1|Baseline|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
470810|NCT00432835|P2|Participant Flow|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal EGG, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
470811|NCT00432835|P1|Participant Flow|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
470812|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
470813|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
470814|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
470815|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
470816|NCT00432835|O2|Outcome|Gastric StimulationNotActivated Days1-4/Activated Days5-8|The sequence followed for patients in Group 2 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal electrogastrogram, then randomization to Group 2, then no stimulation whatsoever until Day 5, then the cross over,then active stimulation with the Gastric Electrical Stimulator for 72 consecutive hours.
470817|NCT00432835|O1|Outcome|Gastric Stimactivated Days1-4/Not Activated Days5-8|The sequence followed for patients in Group 1 was: enrollment and acquisition of baseline data, then placement of electrode, then determination of mucosal Electrogastrogram, then randomization to Group 1, then active stimulation for 72 consecutive hours, then a 1 day wash out, then the cross over, which entailed the device remaining inactive for the final 3 study days
470818|NCT00432835|E2|Reported Event|Gastric StimulationNotActivated|Sham stimulation
470819|NCT00432835|E1|Reported Event|Gastric Stimactivated|Gastric Electrical Stimulation
470820|NCT00432809|B4|Baseline|Total|Total of all reporting groups
470821|NCT00432809|B3|Baseline|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470822|NCT00432809|B2|Baseline|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470823|NCT00432809|B1|Baseline|Medical Therapy|Intensive medical therapy for diabetes
470824|NCT00432809|P3|Participant Flow|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470825|NCT00432809|P2|Participant Flow|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470826|NCT00432809|P1|Participant Flow|Medical Therapy|Intensive medical therapy for diabetes
470827|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470828|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470829|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470830|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470831|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470832|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470833|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470834|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470835|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470836|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470837|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470838|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470839|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470840|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470841|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470842|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470843|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470844|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470845|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470846|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470847|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470848|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470849|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470850|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470851|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470852|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470853|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
490991|NCT00381303|O1|Outcome|Black|
470855|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470856|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470857|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470858|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470859|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470860|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470861|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470862|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470863|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470864|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470865|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470866|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470867|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470868|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470869|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470870|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470871|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470872|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470873|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470874|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470875|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470876|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470877|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470878|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470879|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470880|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470881|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470882|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470883|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470884|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470885|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470886|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470887|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470888|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470889|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470890|NCT00432809|O3|Outcome|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470891|NCT00432809|O2|Outcome|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470892|NCT00432809|O1|Outcome|Medical Therapy|Intensive medical therapy for diabetes
470893|NCT00432809|E3|Reported Event|Sleeve Gastrectomy|Procedure/Surgery: Bariatric surgery - laparoscopic sleeve gastrectomy plus intensive medical therapy
470894|NCT00432809|E2|Reported Event|Gastric Bypass|Procedure/Surgery: Bariatric surgery laparoscopic Roux-en-Y Gastric Bypass (RYGB) plus intensive medical therapy
470895|NCT00432809|E1|Reported Event|Medical Therapy|Intensive medical therapy for diabetes
470896|NCT00432744|B3|Baseline|Total|Total of all reporting groups
470897|NCT00432744|B2|Baseline|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
470898|NCT00432744|B1|Baseline|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
470921|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471118|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
470899|NCT00432744|P2|Participant Flow|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
470900|NCT00432744|P1|Participant Flow|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
470901|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
470902|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
470903|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
470904|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
470905|NCT00432744|O2|Outcome|CoenzymeQ10 Frist|"Patients will be randomized to receive CoenzymeQ10 in Period #1 (Months 0-6) and Placebo given in Period #2( Months 7-12.)~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed.~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group."
470906|NCT00432744|O1|Outcome|Placebo First|"Patients will be randomized to receive Placebo in Period #1 (Months 0-6) and CoenzymeQ10 given in Period #2( Months 7-12.)~Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group.~CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed."
470907|NCT00432744|E2|Reported Event|Placebo|Placebo: Placebo will be given in 10 mg/kg daily up to 400 mg. Then a draw of placebo troughs every three months will be performed. This treatment group will be treated as the active group. (Either in Period 1 or Period 2)
470908|NCT00432744|E1|Reported Event|CoenzymeQ10|CoenzymeQ10: CoenzymeQ10 will be given in 10 mg/kg daily up to 400 mg. Then a draw of CoQ10 troughs every three months will be performed. (Either in Period 1 or Period 2)
470909|NCT00432666|B3|Baseline|Total|Total of all reporting groups
470910|NCT00432666|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470911|NCT00432666|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470912|NCT00432666|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470913|NCT00432666|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470914|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470915|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470916|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470917|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470918|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470919|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470920|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471111|NCT00432458|B2|Baseline|Arm II: ZLD|Zoledronic acid (ZLD)
470922|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470923|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470924|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470925|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470926|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470927|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470928|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470929|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470930|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470931|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470932|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470933|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470934|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470935|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470936|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470937|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470938|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470939|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470940|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470941|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470942|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470943|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470944|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470945|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470946|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470947|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470948|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470949|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470950|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471112|NCT00432458|B1|Baseline|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
470951|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470952|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470953|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470954|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470955|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470956|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470957|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470958|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470959|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470960|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470961|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470962|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470963|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470964|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470965|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470966|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470967|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470968|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470969|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470970|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470971|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470972|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470973|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470974|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470975|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470976|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470977|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470978|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470979|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471113|NCT00432458|P2|Participant Flow|Arm II: ZLD|Zoledronic acid (ZLD)
503623|NCT00340379|O1|Outcome|Ziprasidone|
470980|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470981|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470982|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470983|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470984|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470985|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470986|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470987|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470988|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470989|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470990|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470991|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470992|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470993|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470994|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470995|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470996|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470997|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
470998|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
470999|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471000|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471001|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471002|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471003|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471004|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471005|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471006|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471007|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471008|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471114|NCT00432458|P1|Participant Flow|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471009|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471010|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471011|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471012|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471013|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471014|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471015|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471016|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471017|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471018|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471019|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471020|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471021|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471022|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471023|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471024|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471025|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471026|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471027|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471028|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471029|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471030|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471031|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471032|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471033|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471034|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471035|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471036|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471037|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471115|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471119|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471038|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471039|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471040|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471041|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471042|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471043|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471044|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471045|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471046|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471047|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471048|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471049|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471050|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471051|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471052|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471053|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471054|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471055|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471056|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471057|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471058|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471059|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471060|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471061|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471062|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471063|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471064|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471065|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471066|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471116|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471067|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471068|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471069|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471070|NCT00432666|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471071|NCT00432666|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471072|NCT00432666|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
471073|NCT00432666|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
471074|NCT00432601|B3|Baseline|Total|Total of all reporting groups
471075|NCT00432601|B2|Baseline|Arm 2|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471076|NCT00432601|B1|Baseline|Arm 1|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471077|NCT00432601|P2|Participant Flow|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471078|NCT00432601|P1|Participant Flow|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471079|NCT00432601|O2|Outcome|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471080|NCT00432601|O1|Outcome|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471081|NCT00432601|E2|Reported Event|Arm 2 - NCCN|"Patients will receive National Comprehensive Cancer Network decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471082|NCT00432601|E1|Reported Event|Arm 1 - MCC|"Patients will receive Michigan Cancer Consortium decision aid.~type of decision aid: We will be comparing two decision aids (MCC vs. NCCN) in terms of their impact on decision making and patient-physician communication."
471083|NCT00432562|B3|Baseline|Total|Total of all reporting groups
471084|NCT00432562|B2|Baseline|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
471085|NCT00432562|B1|Baseline|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
471086|NCT00432562|P2|Participant Flow|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530 in the second study period.
471087|NCT00432562|P1|Participant Flow|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine in the second study period.
471088|NCT00432562|O2|Outcome|Navelbine|
471089|NCT00432562|O1|Outcome|ANX-530|
471090|NCT00432562|O2|Outcome|Navelbine|
471091|NCT00432562|O1|Outcome|ANX-530|
471092|NCT00432562|O2|Outcome|Navelbine|
471093|NCT00432562|O1|Outcome|ANX-530|
471094|NCT00432562|O2|Outcome|Navelbine|
471095|NCT00432562|O1|Outcome|ANX-530|
471096|NCT00432562|O2|Outcome|Navelbine|
471097|NCT00432562|O1|Outcome|ANX-530|
471098|NCT00432562|O2|Outcome|Navelbine|
471099|NCT00432562|O1|Outcome|ANX-530|
471100|NCT00432562|O2|Outcome|Navelbine|
471101|NCT00432562|O1|Outcome|ANX-530|
471102|NCT00432562|O2|Outcome|Navelbine|
471103|NCT00432562|O1|Outcome|ANX-530|
471104|NCT00432562|O2|Outcome|Navelbine|
471105|NCT00432562|O1|Outcome|ANX-530|
471106|NCT00432562|O2|Outcome|Navelbine|
471107|NCT00432562|O1|Outcome|ANX-530|
471108|NCT00432562|E2|Reported Event|Navelbine/ANX-530|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of Navelbine in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of ANX-530. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
471109|NCT00432562|E1|Reported Event|ANX-530/Navelbine|Patients were randomly assigned to receive a single intravenous (IV) dose of 30 mg/m2 of ANX 530 in the first study period, then one week later patients crossed over to receive a single IV dose of 30 mg/m2 of Navelbine. Serious Adverse Events are reported by treatment-sequence group and not by study therapy group.
471110|NCT00432458|B3|Baseline|Total|Total of all reporting groups
471120|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471121|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471122|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471123|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471124|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471125|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471126|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471127|NCT00432458|O2|Outcome|Arm II: ZLD|Zoledronic acid (ZLD)
471128|NCT00432458|O1|Outcome|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471129|NCT00432458|E2|Reported Event|Arm II: ZLD|Zoledronic acid (ZLD)
471130|NCT00432458|E1|Reported Event|Arm I: Thal/ZLD|Thalidomide (Thal) + Zolendronic acid (ZLD)
471131|NCT00432445|B1|Baseline|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
471132|NCT00432445|P1|Participant Flow|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
471133|NCT00432445|O1|Outcome|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
471134|NCT00432445|E1|Reported Event|Proton Beam Radiation Therapy|Proton Beam Radiation Therapy given daily for 5 days in a row each week where whole treatment takes about 4-6 weeks. Ophthalmic examination under anesthesia including dilated eye exam, ocular fundus photography (Ret-Cam), ocular echography and neuro-radiologic assessment (as deemed necessary).
471135|NCT00432341|B3|Baseline|Total|Total of all reporting groups
471136|NCT00432341|B2|Baseline|Dysport®|Botulinum toxin type A (Dysport®)
471137|NCT00432341|B1|Baseline|BOTOX®|Botulinum toxin type A (BOTOX®)
471138|NCT00432341|P2|Participant Flow|Dysport®|Botulinum toxin type A (Dysport®)
471139|NCT00432341|P1|Participant Flow|BOTOX®|Botulinum toxin type A (BOTOX®)
471140|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471141|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471142|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471143|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471144|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471145|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471146|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471147|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471148|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471149|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471150|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471151|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471152|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471153|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471154|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471155|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471156|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471157|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471158|NCT00432341|O2|Outcome|Dysport®|Botulinum toxin type A (Dysport®)
471159|NCT00432341|O1|Outcome|BOTOX®|Botulinum toxin type A (BOTOX®)
471160|NCT00432341|E2|Reported Event|Dysport®|Botulinum toxin type A (Dysport®)
471161|NCT00432341|E1|Reported Event|BOTOX®|Botulinum toxin type A (BOTOX®)
471162|NCT00432276|B3|Baseline|Total|Total of all reporting groups
471163|NCT00432276|B2|Baseline|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471164|NCT00432276|B1|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471165|NCT00432276|P2|Participant Flow|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471166|NCT00432276|P1|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471167|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471168|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471169|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471170|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471394|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
562096|NCT00101816|O2|Outcome|Study Day 8|
471171|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471172|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471173|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471174|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471175|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471176|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471177|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471178|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471179|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471180|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471181|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471182|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471183|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471184|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471185|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471186|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471187|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471188|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471189|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471190|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471191|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471192|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471193|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471194|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471195|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471196|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471197|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471198|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
474658|NCT00423332|B1|Baseline|AZD2171 45 mg|AZD2171 45mg/Day
471199|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471200|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471201|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471202|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471203|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471204|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471205|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471206|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471207|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471208|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471209|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471210|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471211|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471212|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471213|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471214|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471215|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471216|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471217|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471218|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471219|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471220|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471221|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471222|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471223|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471224|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471225|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471226|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
475570|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
471227|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471228|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471229|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471230|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471231|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471232|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471233|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471234|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471235|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471236|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471237|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471238|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471239|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471240|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471241|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471242|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471243|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471244|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471245|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471246|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471247|NCT00432276|O2|Outcome|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471248|NCT00432276|O1|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471249|NCT00432276|E2|Reported Event|Pioglitazone 45 mg + Metformin|Alogliptin placebo-matching tablets, orally, once daily; pioglitazone 45 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471250|NCT00432276|E1|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg + Metformin|Alogliptin 25 mg, tablets, orally, once daily; pioglitazone 30 mg, tablets, orally, once daily; and the maximum tolerated dose of metformin, tablets, orally, for up to 52 weeks.
471251|NCT00432159|B6|Baseline|Total|Total of all reporting groups
471252|NCT00432159|B5|Baseline|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471253|NCT00432159|B4|Baseline|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471254|NCT00432159|B3|Baseline|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471255|NCT00432159|B2|Baseline|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471256|NCT00432159|B1|Baseline|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471257|NCT00432159|P5|Participant Flow|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471258|NCT00432159|P4|Participant Flow|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471259|NCT00432159|P3|Participant Flow|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471260|NCT00432159|P2|Participant Flow|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471261|NCT00432159|P1|Participant Flow|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471262|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471263|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471264|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471265|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471266|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471267|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471268|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471269|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471270|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471271|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471272|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471273|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471274|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471275|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471395|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471276|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471277|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471278|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471279|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471280|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471281|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471282|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471283|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471284|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471285|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471286|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471287|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471288|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471289|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471290|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471291|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471292|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471293|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471294|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471295|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471296|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471396|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471538|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471297|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471298|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471299|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471300|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471301|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471302|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471303|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471304|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471305|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471306|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471307|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471308|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471309|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471310|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471311|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471312|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471313|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471314|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471315|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471316|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471317|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471397|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
562097|NCT00101816|O1|Outcome|Study Day 1|
471318|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471319|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471320|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471321|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471322|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471323|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471324|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471325|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471326|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471327|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471328|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471329|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471330|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471331|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471332|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471333|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471334|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471335|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471336|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471337|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471338|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471398|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471339|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471340|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471341|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471342|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471343|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471344|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471345|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471346|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471347|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471348|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471349|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471350|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471351|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471352|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471353|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471354|NCT00432159|O5|Outcome|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471355|NCT00432159|O4|Outcome|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471356|NCT00432159|O3|Outcome|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471357|NCT00432159|O2|Outcome|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471358|NCT00432159|O1|Outcome|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471359|NCT00432159|E5|Reported Event|Training: 1 & 2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single or multiple levels of the cervical spine, C3 to C7 inclusive. Training cohort.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471399|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471360|NCT00432159|E4|Reported Event|2-level ACDF|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at two adjacent levels of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471361|NCT00432159|E3|Reported Event|2-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at two adjacent levels of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471362|NCT00432159|E2|Reported Event|1-level ACDF With Plate|"Anterior Cervical Discectomy and Fusion with plate (ACDF with plate) using allograft spacer and the SLIM-LOC™ Anterior Cervical Plate System at a single level of the cervical spine, C3 to C7 inclusive.~ACDF with plate: Anterior cervical discectomy followed by insertion of allograft spacer and placement of an anterior plate."
471363|NCT00432159|E1|Reported Event|1-level Cervical TDR|"Cervical Total Disc Replacement (Cervical TDR) arthroplasty with the DISCOVER™ Artificial Cervical Disc at a single level of the cervical spine, C3 to C7 inclusive.~Cervical TDR: Cervical total disc replacement using a DISCOVER Artificial Cervical Disc."
471364|NCT00431964|B3|Baseline|Total|Total of all reporting groups
471365|NCT00431964|B2|Baseline|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471366|NCT00431964|B1|Baseline|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471367|NCT00431964|P2|Participant Flow|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471368|NCT00431964|P1|Participant Flow|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471369|NCT00431964|O2|Outcome|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471370|NCT00431964|O1|Outcome|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471371|NCT00431964|E2|Reported Event|Placebo|"placebo tablets (matched to active drug in appearance)~placebo tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471372|NCT00431964|E1|Reported Event|Active|"azithromycin 250 mg tablets~azithromycin 250 mg tablets: *One (1) tablet three times weekly for patients who weigh 40-79 lbs~*Two (2) tablets three times weekly for patients who weigh greater than or equal to 80 lbs"
471373|NCT00431951|B5|Baseline|Total|Total of all reporting groups
471374|NCT00431951|B4|Baseline|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471375|NCT00431951|B3|Baseline|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471376|NCT00431951|B2|Baseline|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471377|NCT00431951|B1|Baseline|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471378|NCT00431951|P4|Participant Flow|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471379|NCT00431951|P3|Participant Flow|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471380|NCT00431951|P2|Participant Flow|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471381|NCT00431951|P1|Participant Flow|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471382|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471383|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471384|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471385|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471386|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471387|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471388|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471389|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471390|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471391|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471392|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471393|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471442|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed 6 month follow-up and had a 24-hour Holter assessment.
471400|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471401|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471402|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471403|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471404|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471405|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471406|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471407|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471408|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471409|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471410|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471411|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471412|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471413|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471414|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471415|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471416|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471417|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471418|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471419|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471420|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471421|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471422|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471423|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471424|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471425|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471426|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose to 6 subjects for 21 days, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471427|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471428|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471429|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471430|NCT00431951|O4|Outcome|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent).
471431|NCT00431951|O3|Outcome|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471432|NCT00431951|O2|Outcome|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471433|NCT00431951|O1|Outcome|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471434|NCT00431951|E4|Reported Event|Placebo|Placebo given as a single daily oral dose for 21 days to 6 subjects, to match ST-246 doses (2 patients for each dose equivalent). Blood and urine samples for PK taken on Days 1, 6, and 21.
471435|NCT00431951|E3|Reported Event|ST-246 800 mg|800 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471436|NCT00431951|E2|Reported Event|ST-246 400mg|400 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days. Blood and urine samples for PK taken on Days 1, 6, and 21.
471437|NCT00431951|E1|Reported Event|ST-246 250 mg|250 mg ST-246 given as a single daily oral dose to 8 subjects for 21 days.
471438|NCT00431834|B1|Baseline|Entire Cohort|All subjects enrolled and treated with the Cardioblate Surgical Ablation System
471439|NCT00431834|P1|Participant Flow|Cardioblate Surgical Ablation System|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 3 subjects died, 7 subjects withdrew from the study, 2 subjects missed the endpoint visit, and 1 subject was lost to follow-up.
471440|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|
471441|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects who were enrolled and were treated with the Cardioblate surgical ablation system with at least 6-month post-operative follow-up or an MAE prior to the end of the 6th month window were included in the analysis.
471443|NCT00431834|O1|Outcome|Cardioblate Surgical Ablation System|All subjects enrolled who completed a Holter assessment at 6 month follow-up.
471444|NCT00431834|E1|Reported Event|Study Completion Cohort|75 subjects were enrolled and treated. 62 subjects completed the study through 6 month follow-up. 4 subjects died, 8 subjects withdrew from the study, and 1 subject was lost to follow-up.
471445|NCT00431626|B3|Baseline|Total|Total of all reporting groups
471446|NCT00431626|B2|Baseline|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
471447|NCT00431626|B1|Baseline|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
471448|NCT00431626|P2|Participant Flow|Placebo|
471449|NCT00431626|P1|Participant Flow|Treatment|
471450|NCT00431626|O2|Outcome|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
471451|NCT00431626|O1|Outcome|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
471452|NCT00431626|E2|Reported Event|Laser TURP With Placebo|Prior to and after standard treatment with laser TURP, placebo is applied to each patient
471453|NCT00431626|E1|Reported Event|Laser TURP With Dutasteride|"Prior to and after standard treatment with laser TURP, dutasteride is applied to each patient~Dutasteride (Avodart)"
471454|NCT00431496|B1|Baseline|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471455|NCT00431496|P1|Participant Flow|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks. Possible sequential doses during the study were 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet occurred if the intact parathyroid hormone (iPTH) level from the previous study visit was > 31.8 pmol/L (300 pg/mL), unless the participant had either reached the maximum dose (180 mg/day), the serum corrected total calcium was < 2.1 mmol/L (8.4 mg/dL), or the participant experienced an adverse event that precluded a dose increase.
471456|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471457|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471458|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471459|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471460|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471461|NCT00431496|O1|Outcome|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471462|NCT00431496|E1|Reported Event|Cinacalcet|Cinacalcet was administered orally at a starting dose of 30 mg/day for 23 weeks.
471463|NCT00431444|B3|Baseline|Total|Total of all reporting groups
471464|NCT00431444|B2|Baseline|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471465|NCT00431444|B1|Baseline|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471466|NCT00431444|P2|Participant Flow|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471467|NCT00431444|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471468|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471469|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471470|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471471|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471472|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471473|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471474|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471475|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471476|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471477|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471478|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471479|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471480|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471481|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471482|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471483|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471484|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471485|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471486|NCT00431444|O2|Outcome|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471487|NCT00431444|O1|Outcome|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471488|NCT00431444|E2|Reported Event|Raloxifene|Placebo (single i.v. infusion) + oral raloxifene 60 mg/day for 6 months (raloxifene group)
471489|NCT00431444|E1|Reported Event|Zoledronic Acid|Zoledronic acid 5 mg (single intravenous (i.v.) infusion) + daily oral placebo for 6 months (zoledronic acid group)
471490|NCT00430950|B3|Baseline|Total|Total of all reporting groups
471491|NCT00430950|B2|Baseline|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471492|NCT00430950|B1|Baseline|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471493|NCT00430950|P2|Participant Flow|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471494|NCT00430950|P1|Participant Flow|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471495|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471496|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471497|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471498|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471499|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471500|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471501|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471502|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471503|NCT00430950|O2|Outcome|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471504|NCT00430950|O1|Outcome|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471505|NCT00430950|E2|Reported Event|OM/HCTZ 20/25 mg + 40/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 20/25mg + 40/25mg matching placebo
471506|NCT00430950|E1|Reported Event|OM/HCTZ 40/25 mg + 20/25 mg Matching Placebo|Olmesartan Medoxomil/Hydrochlorothiazide 40/25 mg with 20/25 mg matching placebo
471507|NCT00430937|B3|Baseline|Total|Total of all reporting groups
471508|NCT00430937|B2|Baseline|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
471509|NCT00430937|B1|Baseline|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
471510|NCT00430937|P2|Participant Flow|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
471511|NCT00430937|P1|Participant Flow|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
471512|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
471513|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
471514|NCT00430937|O2|Outcome|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
471515|NCT00430937|O1|Outcome|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
471516|NCT00430937|E2|Reported Event|Pooled Comparator|Vancomycin 1 g intravenous (i.v.) twice daily or Teicoplanin 400 mg i.v. once daily following a loading dose of 400 mg administered at 0, 12 and 24 hours on day one.
471517|NCT00430937|E1|Reported Event|Daptomycin|Daptomycin 4 mg/kg intravenous (i.v.) once daily
471518|NCT00430781|B4|Baseline|Total|Total of all reporting groups
471519|NCT00430781|B3|Baseline|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471520|NCT00430781|B2|Baseline|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471521|NCT00430781|B1|Baseline|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
471522|NCT00430781|P3|Participant Flow|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471523|NCT00430781|P2|Participant Flow|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471524|NCT00430781|P1|Participant Flow|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
471525|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471526|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471527|NCT00430781|O3|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
471528|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471529|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471530|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471531|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471532|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471533|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471534|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471535|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471536|NCT00430781|O2|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471537|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
475683|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
471539|NCT00430781|O1|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471540|NCT00430781|O3|Outcome|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471541|NCT00430781|O2|Outcome|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471542|NCT00430781|O1|Outcome|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
471543|NCT00430781|E3|Reported Event|Pazopanib Monotherapy|800 mg (2 x 400 mg tablets) of oral pazopanib daily
471544|NCT00430781|E2|Reported Event|Lapatinib Monotherapy|1500 mg (6 x 250 mg tablets) of oral lapatinib daily
471545|NCT00430781|E1|Reported Event|Combination Therapy: Lapatinib 1500 mg and Pazopanib 800 mg|Lapatinib 1500 mg (6 x 250 mg tablets) and pazopanib 800 mg (2 x 400 mg tablets) daily
471546|NCT00430768|B4|Baseline|Total|Total of all reporting groups
471547|NCT00430768|B3|Baseline|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
471548|NCT00430768|B2|Baseline|Group 2 Middle Dose|"2.1 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x1013 vg"
471549|NCT00430768|B1|Baseline|Group 1 Low Dose|"6.9 x10e12 vector genomes~Group 1 receives rAAV1-CB-hAAT 6.9 x1012 vg (vector genomes), e"
471550|NCT00430768|P3|Participant Flow|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
471551|NCT00430768|P2|Participant Flow|Group 2 Middle Dose|"2.1 x 10e13 vector genomes; 2.2 x 10e13 vector genomes~Group 2, 1 subject received rAAV1-CB-hAAT 2.1 x10e13 vg; 202 and 203 received rAAV1-CB-hAAT 2.2 x10e13 vg"
471552|NCT00430768|P1|Participant Flow|Group 1 Low Dose|"6.9 x10e12 vector genomes (vg)~Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg."
471553|NCT00430768|O6|Outcome|303 (High Dose)|Subject 303 M-specific AAT Level
471554|NCT00430768|O5|Outcome|302 (High Dose)|Subject 302 M-specific AAT Level
471555|NCT00430768|O4|Outcome|301 (High Dose)|Subject 301M-specific AAT Level
471556|NCT00430768|O3|Outcome|203 (Medium Dose)|Subject 203 M-specific AAT Level
471557|NCT00430768|O2|Outcome|202 (Medium Dose)|Subject 202 M-specific AAT Level
471558|NCT00430768|O1|Outcome|201 (Medium Dose)|Subject 201 M-specific AAT Level
471559|NCT00430768|O3|Outcome|Group 3 High Dose|
471560|NCT00430768|O2|Outcome|Group 2 Middle Dose|
471561|NCT00430768|O1|Outcome|Group 1 Low Dose|
471562|NCT00430768|E3|Reported Event|Group 3 High Dose|"rAAV1-CB-hAAT 6.0 x10e13 vg~Group 3 receives rAAV1-CB-hAAT 6.0 x10e13 vg"
471563|NCT00430768|E2|Reported Event|Group 2 Middle Dose|"2.2 x 10e13 vector genomes~Group 2 receives rAAV1-CB-hAAT 2.1 x10e13 vg"
471564|NCT00430768|E1|Reported Event|Group 1 Low Dose|"6.9 x10e12 vector genomes~e. Group 1 receives rAAV1-CB-hAAT 6.9 x10e12 vg (vector genomes)"
471565|NCT00430755|B1|Baseline|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
471566|NCT00430755|P1|Participant Flow|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
471567|NCT00430755|O1|Outcome|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
471568|NCT00430755|E1|Reported Event|Inpatients With the Need for History Taking|Every patient, who needs to get a medical history taken
471569|NCT00430716|B4|Baseline|Total|Total of all reporting groups
471570|NCT00430716|B3|Baseline|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471571|NCT00430716|B2|Baseline|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471572|NCT00430716|B1|Baseline|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471573|NCT00430716|P3|Participant Flow|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471574|NCT00430716|P2|Participant Flow|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471575|NCT00430716|P1|Participant Flow|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471576|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471577|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471578|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471579|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471580|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471581|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471753|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471582|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471583|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471584|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471585|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471586|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471587|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471588|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471589|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471590|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471591|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471592|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471593|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471594|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471595|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471596|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471597|NCT00430716|O3|Outcome|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471598|NCT00430716|O2|Outcome|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471599|NCT00430716|O1|Outcome|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471600|NCT00430716|E3|Reported Event|Sildenafil 20 mg|Sildenafil 20 mg tablet taken orally TID throughout the study and placebo matched to 1 and 5 mg during first 12 weeks (double blind treatment phase).
471601|NCT00430716|E2|Reported Event|Sildenafil 5 mg|Sildenafil 5 mg tablet taken orally TID for first 12 weeks (double blind treatment phase of the study) and placebo matched to 1 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471602|NCT00430716|E1|Reported Event|Sildenafil 1 mg|Sildenafil 1 milligram (mg) tablet taken orally 3 times a day (TID) for first 12 weeks (double blind treatment phase of the study) and placebo matched to 5 and 20 mg. For a further 12 weeks (open label extension phase), participants received sildenafil 20 mg tablets TID.
471603|NCT00430677|B4|Baseline|Total|Total of all reporting groups
471604|NCT00430677|B3|Baseline|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471605|NCT00430677|B2|Baseline|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471606|NCT00430677|B1|Baseline|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471607|NCT00430677|P3|Participant Flow|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471754|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471608|NCT00430677|P2|Participant Flow|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471609|NCT00430677|P1|Participant Flow|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471610|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471611|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471612|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471613|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471614|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471615|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471616|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471617|NCT00430677|O1|Outcome|Abatacept 10 mg/kg|Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471618|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471619|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471620|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period: Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by intravenous (IV) infusion in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent.
471621|NCT00430677|O3|Outcome|Placebo|Short-term period: Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) Short-term period: by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471622|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Short-term period: Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471645|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471755|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471623|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471624|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471625|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471626|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Short-term period: Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent Long-term extension period:Participants received abatacept in a weight-tiered dose of approximately 10 mg/kg administered every 28 days by IV infusion in addition to oral MMF and oral prednisone or prednisone-equivalent.
471627|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471628|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471629|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471630|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471631|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471632|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471633|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471634|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471635|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471636|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471637|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471638|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471639|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471640|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471641|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471642|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471643|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471644|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471646|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471647|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471648|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471649|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471650|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471651|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471652|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471653|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471654|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471655|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471656|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471657|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471658|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471659|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471660|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471661|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471662|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471663|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471664|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471665|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471666|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471667|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471668|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471669|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471670|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471999|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471671|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471672|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471673|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471674|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471675|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471676|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471677|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471678|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471679|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471680|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471681|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471682|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471683|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471684|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471685|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471686|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471687|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471688|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471689|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471690|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471691|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471692|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471693|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471694|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471695|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
480055|NCT00409838|O1|Outcome|Abatacept 500 mg|
471696|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471697|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471698|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471699|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471700|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471701|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471702|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471703|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471704|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471705|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471706|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471707|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471708|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471709|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471710|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471711|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471712|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471713|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471714|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471715|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471716|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471717|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471718|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471719|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by IV infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471720|NCT00430677|O3|Outcome|Placebo|Placebo (dextrose 5% in water) or normal saline by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471752|NCT00430625|P1|Participant Flow|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471721|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycofenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
471722|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg on Days 1, 15, 29, and 57, followed by abatacept approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471723|NCT00430677|O3|Outcome|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471724|NCT00430677|O2|Outcome|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471725|NCT00430677|O1|Outcome|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57, followed by abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
471726|NCT00430677|E3|Reported Event|Placebo|Placebo (Dextrose 5% in water [D5W]) or Normal Saline (NS) by IV infusion on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent
471727|NCT00430677|E2|Reported Event|Abatacept 10/10 mg/kg|Abatacept 10/10 mg/kg regimen by IV infusion: Participants received abatacept (fixed dose) approximating 10 mg/kg on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral MMF and oral prednisone or prednisone-equivalent.
471728|NCT00430677|E1|Reported Event|Abatacept 30/10 mg/kg|Abatacept 30/10 mg/kg regimen by intravenous (IV) infusion: In the double-blind period, participants received abatacept 30 mg/kg (by weight) on Days 1, 15, 29, and 57. In the open-label period, participants received abatacept (fixed dose) approximating 10 mg/kg on Days 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337 in addition to oral Mycophenolate mofetil (MMF) and oral prednisone or prednisone-equivalent
471729|NCT00430638|B3|Baseline|Total|Total of all reporting groups
471730|NCT00430638|B2|Baseline|Placebo Group|Participants were randomized to a placebo (Pbo) group. The Pbo participants remained in the pbo group for the entire 12 weeks of treatment.
471731|NCT00430638|B1|Baseline|Olmesartan Group|Participants were randomized to an olmesartan (Olm) based active treatment group. After 3,6,and 9 weeks of treatment participants were titrated to the next regiment if their blood pressure was greater than 120/80 mmHg. The active treatment group received olm 20 mg (weeks 1-3), olm 40 mg (weeks 4-6), olm 40 mg + 12.5 mg hydrchlorothiazide (HCTZ) (weeks 7-9), and olm 40 mg + 25 mg HCTZ (weeks 10-12).
471732|NCT00430638|P2|Participant Flow|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
471733|NCT00430638|P1|Participant Flow|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
471734|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471735|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471736|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471737|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471738|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471739|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471740|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|145 females participants were analyzed.
471741|NCT00430638|O1|Outcome|Olmesartan vs. Placebo|
471742|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesartan medoxomil tablets + hydrochlorothiazide tablets, if necessary, once daily for the duration of the 12-week active treatment period.
471743|NCT00430638|O1|Outcome|Placebo Group|Patient received placebo tablets throughout the 12-week active treatment period.
471744|NCT00430638|O2|Outcome|Olmesartan Group|Participants received olmesatan medoxomil plus hydrochlorothiazide, if necessary.
471745|NCT00430638|O1|Outcome|Placebo|Patient received placebo tablets.
471746|NCT00430638|E2|Reported Event|Olmesartan Group|140 participants were randomized to the olmesartan group. These participants remained in this group for the entire study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on olmesartan 20 mg; after 3 weeks, if necessary, olmesartan 40 mg; after 6 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, olmesartan 40 mg + hydrochlorothiazide 25 mg.
471747|NCT00430638|E1|Reported Event|Placebo (Pbo) Group|138 were randomized to placebo. Participants remained in the placebo group for the duration of the study. The study medication was titrated at 3-week intervals if blood pressure goals were not achieved. The medications were: all started on placebo matching olmesartan 20 mg; after 3 weeks, if necessary, placebo matching olmesartan 40 mg; after 6 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 12.5 mg; after 9 weeks, if necessary, placebo matching olmesartan 40 mg + hydrochlorothiazide 25 mg.
471748|NCT00430625|B3|Baseline|Total|Total of all reporting groups
471749|NCT00430625|B2|Baseline|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471750|NCT00430625|B1|Baseline|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471751|NCT00430625|P2|Participant Flow|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
472000|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471756|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471757|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471758|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471759|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471760|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471761|NCT00430625|O2|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471762|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471763|NCT00430625|O1|Outcome|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471764|NCT00430625|O1|Outcome|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471765|NCT00430625|E2|Reported Event|VPRIV® (60 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471766|NCT00430625|E1|Reported Event|VPRIV® (45 U/kg, IV, Every Other Week)|velaglucerase alfa, Gene Activated® human glucocerebrosidase, GA-GCB
471767|NCT00430508|B5|Baseline|Total|Total of all reporting groups
471768|NCT00430508|B4|Baseline|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
471769|NCT00430508|B3|Baseline|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
471770|NCT00430508|B2|Baseline|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
471771|NCT00430508|B1|Baseline|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
471772|NCT00430508|P4|Participant Flow|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/0mg tablets, once daily for 8 weeks
471773|NCT00430508|P3|Participant Flow|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 20/12.5mg tablets, once daily for 8 weeks
471774|NCT00430508|P2|Participant Flow|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/12.5mg tablets, once daily for 8 weeks
471775|NCT00430508|P1|Participant Flow|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/Hydrochlorothizaide 40/25mg tablets, once daily for 8 weeks
471776|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471777|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471778|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471779|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471780|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471781|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471782|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471783|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471784|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471785|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471786|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471787|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471788|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471789|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471790|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471791|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471792|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471793|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471794|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471795|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471796|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
480320|NCT00409344|E1|Reported Event|Saline|This group will recive saline
471797|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471798|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471799|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471800|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471801|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471802|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471803|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471804|NCT00430508|O4|Outcome|OM/HCTZ 40/0mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/0mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471805|NCT00430508|O3|Outcome|OM/HCTZ 20/12.5mg + 40/0 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 20mg/12.5mg + 40mg/0mg matching placebo tablet once daily for 8 weeks
471806|NCT00430508|O2|Outcome|OM/HCTZ 40/12.5mg + 20/12.5 Matching Placebo|olmesartan medoxomil/hydrochlorothiazide tablets 40mg/12.5mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471807|NCT00430508|O1|Outcome|OM/HCTZ 40/25mg + 20/12.5 Matching Placebo|olmesartan medoxomil/HCTZ Tablet 40mg/25mg + 20mg/12.5mg matching placebo tablet once daily for 8 weeks
471808|NCT00430495|B5|Baseline|Total|Total of all reporting groups
471809|NCT00430495|B4|Baseline|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471810|NCT00430495|B3|Baseline|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471811|NCT00430495|B2|Baseline|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471812|NCT00430495|B1|Baseline|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471813|NCT00430495|P4|Participant Flow|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471814|NCT00430495|P3|Participant Flow|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471815|NCT00430495|P2|Participant Flow|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471816|NCT00430495|P1|Participant Flow|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471817|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471818|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471819|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471820|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471821|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471822|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471823|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471824|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471825|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471826|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471827|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471828|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471829|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471830|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471831|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
472350|NCT00428597|B1|Baseline|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
471832|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471833|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471834|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471835|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471836|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471837|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471838|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471839|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471840|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471841|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471842|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471843|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471844|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471845|NCT00430495|O4|Outcome|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471846|NCT00430495|O3|Outcome|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471847|NCT00430495|O2|Outcome|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471848|NCT00430495|O1|Outcome|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471849|NCT00430495|E4|Reported Event|Atacicept 150 mg|Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks.
471850|NCT00430495|E3|Reported Event|Atacicept 75 mg|Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks.
471851|NCT00430495|E2|Reported Event|Atacicept 25 mg|Atacicept was administered subcutaneously at a dose of 25 mg twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks.
471852|NCT00430495|E1|Reported Event|Placebo|Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.
471853|NCT00430352|B1|Baseline|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471854|NCT00430352|P1|Participant Flow|Rituximab 375 Milligrams Per Square Meter (mg/m^2)|Participants received rituximab 375 mg/m^2 intravenously (IV) once every 8 weeks for a total 12 infusions until progression, relapse, start of a new treatment, death, or toxicity.
471855|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471856|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471857|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471858|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471859|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471860|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471861|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471862|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471863|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471864|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
472351|NCT00428597|P2|Participant Flow|Placebo|Matching placebo.
471865|NCT00430352|O1|Outcome|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471866|NCT00430352|E1|Reported Event|Rituximab 375 mg/m^2|Participants received rituximab 375 mg/m^2 IV for up to 12 infusions in total every 8 weeks until progression, relapse, start of a new treatment, death, or toxicity.
471867|NCT00430300|B5|Baseline|Total|Total of all reporting groups
471868|NCT00430300|B4|Baseline|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471869|NCT00430300|B3|Baseline|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471870|NCT00430300|B2|Baseline|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471871|NCT00430300|B1|Baseline|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471872|NCT00430300|P4|Participant Flow|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471873|NCT00430300|P3|Participant Flow|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471874|NCT00430300|P2|Participant Flow|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471875|NCT00430300|P1|Participant Flow|UK-432,097 150 Mcg|UK-432,097 150 microgram (mcg) capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide metered dose inhaler (MDI) 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471876|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471877|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471878|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471879|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471880|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471881|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471882|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471998|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471883|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471884|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471885|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471886|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471887|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471888|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471889|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471890|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471891|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471892|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471893|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471894|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471895|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471896|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471897|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471898|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471899|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
480402|NCT00408993|B3|Baseline|Total|Total of all reporting groups
471900|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471901|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471902|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471903|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471904|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471905|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471906|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471907|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471908|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471909|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471910|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471911|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471912|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471913|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471914|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471915|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471916|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
482283|NCT00403481|O1|Outcome|Overall Study Population|
471917|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471918|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471919|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471920|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471921|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471922|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471923|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471924|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471925|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471926|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471927|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471928|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471929|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471930|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471931|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471932|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471933|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
482365|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
471934|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471935|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471936|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471937|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471938|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471939|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471940|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471941|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471942|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471943|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471944|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471945|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471946|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471947|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471948|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471949|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471950|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
482366|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
471951|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471952|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471953|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471954|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471955|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471956|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471957|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471958|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471959|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471960|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471961|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471962|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471963|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471964|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471965|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471966|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471967|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
482367|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
471968|NCT00430300|O4|Outcome|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471969|NCT00430300|O3|Outcome|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471970|NCT00430300|O2|Outcome|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471971|NCT00430300|O1|Outcome|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471972|NCT00430300|E4|Reported Event|Placebo|Placebo matching to UK-432,097 capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471973|NCT00430300|E3|Reported Event|UK-432,097 1350 Mcg|UK-432,097 1350 mcg (3 * 450 mcg capsules) twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471974|NCT00430300|E2|Reported Event|UK-432,097 450 Mcg|UK-432,097 450 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471975|NCT00430300|E1|Reported Event|UK-432,097 150 Mcg|UK-432,097 150 mcg capsule and 2 matching placebo capsules twice daily up to Week 6, administered by inhalation using the single pin mono-dose capsule inhaler device. Additionally, participants received ipratropium bromide MDI 2 actuations (20 mcg/actuation) 4 times daily as a maintenance therapy up to Week 8 and salbutamol MDI 1 to 2 actuations (100 mcg/actuation) as rescue therapy whenever required.
471976|NCT00430248|B4|Baseline|Total|Total of all reporting groups
471977|NCT00430248|B3|Baseline|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471978|NCT00430248|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471979|NCT00430248|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471980|NCT00430248|P3|Participant Flow|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471981|NCT00430248|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471982|NCT00430248|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471983|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471984|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471985|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471986|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471987|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471988|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471989|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471990|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471991|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471992|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471993|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471994|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
471995|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
471996|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
471997|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472001|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472002|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472003|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472004|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472005|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472006|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472007|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472008|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472009|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472010|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472011|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472012|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472013|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472014|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472015|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472016|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472017|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472018|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472019|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472020|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472021|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472022|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472023|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472024|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472025|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472026|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472027|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472028|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472029|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472030|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472031|NCT00430248|O3|Outcome|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472032|NCT00430248|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472033|NCT00430248|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472034|NCT00430248|E3|Reported Event|Allopurinol 200 mg or 300 mg QD|Allopurinol, orally, for up to 6 months. Dose of allopurinol received was based on renal status. Subjects with normal renal function or mild renal impairment received 300 mg QD; subjects with moderate renal impairment received 200 mg QD.
472035|NCT00430248|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 6 months.
472036|NCT00430248|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily for up to 6 months.
472037|NCT00430092|B4|Baseline|Total|Total of all reporting groups
472038|NCT00430092|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472039|NCT00430092|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
472040|NCT00430092|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
472174|NCT00429494|E1|Reported Event|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
482368|NCT00402987|O4|Outcome|Placebo|
472041|NCT00430092|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472042|NCT00430092|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
472043|NCT00430092|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
472044|NCT00430092|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472045|NCT00430092|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days
472046|NCT00430092|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days
472047|NCT00430027|B1|Baseline|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
472048|NCT00430027|P1|Participant Flow|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
472049|NCT00430027|O1|Outcome|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
472050|NCT00430027|E1|Reported Event|Capecitabine, Oxaliplatin, Cetuximab, and Radiation Therapy|Patients enrolled on the trial received neoadjuvant combined capecitabine, oxaliplatin, cetuximab, and radiation therapy. This was followed by surgical resection and adjuvant capecitabine, oxaliplatin, and cetuximab
472051|NCT00429949|B1|Baseline|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
472052|NCT00429949|P1|Participant Flow|Dasatinib|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
472053|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472054|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472055|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472056|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472057|NCT00429949|O1|Outcome|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472058|NCT00429949|O2|Outcome|Dasatinib 100 mg BID|In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle.
472059|NCT00429949|O1|Outcome|Dasatinib 70 mg BID|Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.
472060|NCT00429949|E1|Reported Event|Dasatinib|"Dasatinib will be administered continuously at an oral dose of 70 mg BID on Days 1-28 of each 28 day cycle.~In patients with stable disease after 8 weeks on therapy the dasatinib will be increased to 100 mg BID on Days 1-28 on each 28 day cycle."
472061|NCT00429923|B4|Baseline|Total|Total of all reporting groups
472062|NCT00429923|B3|Baseline|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472063|NCT00429923|B2|Baseline|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
472064|NCT00429923|B1|Baseline|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
472065|NCT00429923|P3|Participant Flow|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472066|NCT00429923|P2|Participant Flow|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
472067|NCT00429923|P1|Participant Flow|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
472068|NCT00429923|O3|Outcome|Placebo|Placebo for 14 days. Placebo was administered BID for 14 days and QID for 14 days. The outcomes of the 2 placebo groups were examined and were determined to be statistically indistinguishable so the placebo groups were pooled for comparison with the difluprednate groups.
472069|NCT00429923|O2|Outcome|Difluprednate 0.05% QID|Difluprednate 0.05% 1 drop QID for 14 days.
472070|NCT00429923|O1|Outcome|Difluprednate 0.05% BID|Difluprednate 0.05% 1 drop BID for 14 days.
472071|NCT00428844|B4|Baseline|Total|Total of all reporting groups
472072|NCT00428844|B3|Baseline|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472073|NCT00428844|B2|Baseline|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472074|NCT00428844|B1|Baseline|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472343|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472075|NCT00428844|P3|Participant Flow|Comparator|Vancomycin was administered at 1 gram (gm)every 12 hours (q12h) as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472076|NCT00428844|P2|Participant Flow|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30 minute IV infusion for 6 weeks (± one week).
472077|NCT00428844|P1|Participant Flow|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg every 24 hours [q24h]) as a 30 minute intravenous (IV) infusion for 6 weeks (± one week).
472078|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472079|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472080|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472081|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472082|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472083|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472084|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472085|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472086|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472087|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472088|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472089|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472090|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472091|NCT00428844|O3|Outcome|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472092|NCT00428844|O2|Outcome|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472093|NCT00428844|O1|Outcome|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472094|NCT00428844|E3|Reported Event|Comparator|Vancomycin was administered at 1 gm q12h as a 60-minute infusion and teicoplanin was administered 6 mg/kg q24h as a 30-minute infusion also for 6 weeks (±1 week). Semi-synthetic penicillin (nafcillin, oxacillin, or flucloxacillin) was administered according to standard of care for 6 weeks (±1 week).
472095|NCT00428844|E2|Reported Event|Daptomycin 8 mg/kg|Daptomycin (8 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472096|NCT00428844|E1|Reported Event|Daptomycin 6 mg/kg|Daptomycin (6 mg/kg q24h) as a 30-minute IV infusion for 6 weeks (±1 week).
472097|NCT00428792|B3|Baseline|Total|Total of all reporting groups
472098|NCT00428792|B2|Baseline|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472099|NCT00428792|B1|Baseline|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472100|NCT00428792|P2|Participant Flow|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472101|NCT00428792|P1|Participant Flow|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472102|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472175|NCT00429416|B1|Baseline|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
562098|NCT00101816|O3|Outcome|Total|
472103|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472104|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472105|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472106|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472107|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472108|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472109|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472110|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472111|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472112|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472113|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472114|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472115|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472116|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472117|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472139|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
472118|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472119|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472120|NCT00428792|O2|Outcome|Standard Breakfast (SB) Treatment Group|Standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472121|NCT00428792|O1|Outcome|Very Light Breakfast (VLB) Treatment Group|Very Light Breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472122|NCT00428792|E2|Reported Event|Standard Breakfast (SB) Then Very Light Breakfast (VLB)|Standard breakfast (SB) for one week then crossover to very light breakfast (VLB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12.
472123|NCT00428792|E1|Reported Event|Very Light Breakfast (VLB) Then Standard Breakfast (SB)|Very light breakfast (VLB) for one week then crossover to standard breakfast (SB) for one week while taking either 20 mg or 40 mg capsules of methylphenidate once daily based on the dosage the child had taken in the month prior to study start. VLB is defined as 150 kcal for children age 6-9 and 180 kcal for children age 10-12. SB is defined as 450 kcal for girls age 6-9, 490 kcal for boys age 6-9, 550 kcal for girls age 10-12, and 600 kcal for boys age 10-12.
472124|NCT00429793|B1|Baseline|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472125|NCT00429793|P1|Participant Flow|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472126|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472127|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472128|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472129|NCT00429793|O1|Outcome|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472130|NCT00429793|E1|Reported Event|Treatment (Temsirolimus)|Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
472131|NCT00429702|B3|Baseline|Total|Total of all reporting groups
472132|NCT00429702|B2|Baseline|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
472133|NCT00429702|B1|Baseline|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
472134|NCT00429702|P2|Participant Flow|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
472135|NCT00429702|P1|Participant Flow|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
472136|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
472137|NCT00429702|O1|Outcome|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
472138|NCT00429702|O2|Outcome|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
472173|NCT00429494|O1|Outcome|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
472140|NCT00429702|E2|Reported Event|Control Arm Saline|"Patients receive ondansetron hydrochloride IV twice daily and dexamethasone IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive saline by continuous infusion pump.~Decadron®: Given IV~ondansetron hydrochloride: Given IV"
472141|NCT00429702|E1|Reported Event|Benadryl® Ativan® Decadron® (BAD) Pump|"Patients receive ondansetron hydrochloride IV twice daily and saline IV twice daily beginning 30-60 minutes prior to the start of chemotherapy. Patients also receive diphenhydramine hydrochloride, lorazepam, and dexamethasone by continuous infusion pump.~Decadron®: Given IV~Benadryl®: Given IV~Ativan®: Given IV~ondansetron hydrochloride: Given IV"
472142|NCT00429663|B3|Baseline|Total|Total of all reporting groups
472143|NCT00429663|B2|Baseline|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472144|NCT00429663|B1|Baseline|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472145|NCT00429663|P2|Participant Flow|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472146|NCT00429663|P1|Participant Flow|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472147|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472148|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472149|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472150|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472151|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472152|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472153|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472154|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472155|NCT00429663|O2|Outcome|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472156|NCT00429663|O1|Outcome|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472157|NCT00429663|E2|Reported Event|Plate Fixation|"Locking Periarticular Plate - Randomized Treatment~locking periarticular plate: Standard of care device for femur fractures"
472158|NCT00429663|E1|Reported Event|IM Nails|"Reamed, Interlocking Intramedullary Nail - Randomized treatment~reamed, interlocking intramedullary nail: Standard of care device for femur fracture repair"
472159|NCT00429572|B1|Baseline|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472160|NCT00429572|P1|Participant Flow|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472161|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472162|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472163|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472164|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472165|NCT00429572|O1|Outcome|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472166|NCT00429572|E1|Reported Event|Allogeneic Transplantation|Intravenous Fludarabine 30 mg/m^2 daily on days 1-5, and Melphalan 70 mg/m^2 on days 4 and 5 followed by blood stem cell transplant on day 7.
472167|NCT00429507|B1|Baseline|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
472168|NCT00429507|P1|Participant Flow|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
472169|NCT00429507|O1|Outcome|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
472170|NCT00429507|E1|Reported Event|Samarium 153-EDTMP + Stem Cell Transplant|Samarium 153-EDTMP tracer dose = 30 millicurie (mCi) intravenous Day 1; or with study drug to bones, receive higher therapy dose of 153 Sm-EDTMP 7-14 days after tracer dose. Stem Cell Transplant Day 0, about 14-21 days after Samarium 153-EDTMP.
472171|NCT00429494|B1|Baseline|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before HSCT transplant and 3 months post-transplant.
472172|NCT00429494|P1|Participant Flow|Leuprolide Acetate|Leuprolide Acetate 22.5 mg intramuscular (IM) injection 2 months before hematopoietic stem cell transplantation (HSCT) transplant and 3 months post-transplant.
472176|NCT00429416|P1|Participant Flow|LLME to Decrease GVHD Following HSC T|"To determine if an experimental agent, L-leucyl-L-leucine Methyl Ester (LLME), can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).~Treatment Outline:~Day -6: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV Day -5: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -4: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -3: Fludarabine 30 mg/m2 IV, Cyclophosphamide 1 gm/m2 IV, Mesna 1 gm/m2 IV Day -2: Fludarabine 30 mg/m2 IV, Cytarabine 2 gm/m2 IV, Mesna 1 gm/m2 IV Day -1: Rest day Day 0: CD34 selected allogeneic stem cell infusion with 5x104/kg untreated T cells Day 1: Infusion of LLME treated donor CD34 – cells"
472177|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472178|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472179|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472180|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472181|NCT00429416|O1|Outcome|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472182|NCT00429416|E1|Reported Event|LLME to Decrease GVHD Following HSC T|To determine if an experimental agent, LLME, can decrease the incidence and severity of Graft-Versus-Host-Disease (GVHD) following hematopoietic stem cell transplantation (HSCT).
472183|NCT00429403|B3|Baseline|Total|Total of all reporting groups
472184|NCT00429403|B2|Baseline|No Goserelin|
472185|NCT00429403|B1|Baseline|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
472186|NCT00429403|P2|Participant Flow|No Goserelin|
472187|NCT00429403|P1|Participant Flow|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
472188|NCT00429403|O2|Outcome|No Goserelin|
472189|NCT00429403|O1|Outcome|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
472190|NCT00429403|E2|Reported Event|No Goserelin|
472191|NCT00429403|E1|Reported Event|Goserelin|3.6 mg subcutaneously 1 week before chemotherapy, then once a month until 3 weeks after chemotherapy.
472192|NCT00429364|B3|Baseline|Total|Total of all reporting groups
472193|NCT00429364|B2|Baseline|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472194|NCT00429364|B1|Baseline|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472195|NCT00429364|P2|Participant Flow|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472196|NCT00429364|P1|Participant Flow|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472197|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472198|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472199|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472200|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472201|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472202|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472203|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472204|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472205|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472206|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472207|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472208|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472209|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472210|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472211|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472212|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472213|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472214|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472215|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472216|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472217|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472218|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472219|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472220|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472221|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472222|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472223|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472224|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472225|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472226|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472227|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472228|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472229|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472230|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472231|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472232|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472233|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472234|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472235|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472236|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472237|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472238|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472239|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472240|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472344|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472241|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472242|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472243|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472244|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472245|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472246|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472247|NCT00429364|O2|Outcome|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472248|NCT00429364|O1|Outcome|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472249|NCT00429364|E2|Reported Event|Losartan|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.4 - 1.4 mg/kg/day Losartan (not to exceed a total dose of 100 mg).
472250|NCT00429364|E1|Reported Event|Atenolol|Participants with Marfan’s syndrome and ≥3 maximum aortic root z-score received 0.5 - 4.0 mg/kg/day Atenolol (not to exceed a total dose of 250 mg), with a goal of a 20% or greater decrease in the mean heart rate.
472251|NCT00429299|B4|Baseline|Total|Total of all reporting groups
472252|NCT00429299|B3|Baseline|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
472253|NCT00429299|B2|Baseline|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
472254|NCT00429299|B1|Baseline|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472255|NCT00429299|P3|Participant Flow|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
472256|NCT00429299|P2|Participant Flow|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
472257|NCT00429299|P1|Participant Flow|Chemotherapy (CT) Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472286|NCT00429182|P1|Participant Flow|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target area under the curve (AUC) of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
472258|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472259|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472260|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472261|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472262|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472263|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472264|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472265|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472266|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472287|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
472345|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472346|NCT00428922|O1|Outcome|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472267|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472268|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472269|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472270|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472271|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472272|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472273|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472274|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472275|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472288|NCT00429182|O1|Outcome|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
472347|NCT00428922|E1|Reported Event|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472348|NCT00428597|B3|Baseline|Total|Total of all reporting groups
472349|NCT00428597|B2|Baseline|Placebo|Matching placebo.
472276|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472277|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472278|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472279|NCT00429299|O3|Outcome|CT Plus Trastuzumab and Lapatinib 1000 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach."
472280|NCT00429299|O2|Outcome|CT Plus Lapatinib 1500 mg|"Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery.~Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach."
472281|NCT00429299|O1|Outcome|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472282|NCT00429299|E3|Reported Event|CT Plus Trastuzumab and Lapatinib 1000 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 mg/kg IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Participants received lapatinib 1000 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following IDMC recommendations, lapatinib doses were reduced to 750 mg/day orally on an empty stomach.
472283|NCT00429299|E2|Reported Event|CT Plus Lapatinib 1500 mg|Participants received CT, which included paclitaxel 80 mg/m^2 weekly for 12 weeks, followed by IV fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Participants received lapatinib 1500 mg/day orally on an empty stomach throughout the course of the CT and for three weeks after the last CT administration. Treatments were administered for 26 weeks prior to surgery. Following Independent Data Monitoring Committee (IDMC) recommendations, lapatinib doses were reduced to 1250 mg/day orally on an empty stomach.
472284|NCT00429299|E1|Reported Event|CT Plus Trastuzumab|Participants received chemotherapy (CT), which included paclitaxel 80 milligrams per meters squared (mg/m^2) weekly for 12 weeks, followed by intravenous (IV) fluorouracil 600 mg/m^2, IV epidoxorubicin 75 mg/m^2, and IV cyclophosphamide 600 mg/m^2, once every 21 days for four treatment courses. Trastuzumab was administered throughout the course of the CT and for two weeks after the last CT administration. The first dose of trastuzumab was administered at 4 milligrams per kilogram (mg/kg) IV for 60 minutes on the day of the first paclitaxel course. Subsequent administrations were given weekly at 2 mg/kg IV for 30 minutes. Treatments were administered for 26 weeks prior to surgery.
472285|NCT00429182|B1|Baseline|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
472341|NCT00428922|B1|Baseline|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472342|NCT00428922|P1|Participant Flow|Trastuzumab, Bevacizumab, and Docetaxel|Trastuzumab [6mg/kg], Bevacizumab [15mg/kg], and Docetaxel [75 mg/M²]
472289|NCT00429182|E1|Reported Event|High-dose Chemotherapy|"Carboplatin + Cyclophosphamide + Thiotepa~Carboplatin : Target AUC of 20, then divided into 4 doses given by vein (IV) days -6, -5, -4, -3 prior to stem cell infusion.~Thiotepa : 120 mg/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion.~Stem Cell Transplant : Stem Cell Transplant on Day 0.~Cyclophosphamide : 1.5 gm/m^2 by vein days -6, -5, -4, -3 prior to stem cell infusion."
472290|NCT00429169|B3|Baseline|Total|Total of all reporting groups
472291|NCT00429169|B2|Baseline|Bupropion|Participants will receive bupropion for 8 weeks
472292|NCT00429169|B1|Baseline|Paroxetine|Participants will receive paroxetine for 8 weeks
472293|NCT00429169|P2|Participant Flow|Bupropion|Participants will receive bupropion for 8 weeks
472294|NCT00429169|P1|Participant Flow|Paroxetine|Participants will receive paroxetine for 8 weeks
472295|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
472296|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
472297|NCT00429169|O2|Outcome|Bupropion|Bupropion acute treatment for 8 weeks.
472298|NCT00429169|O1|Outcome|Paroxetine|Paroxetine acute treatment for 8 weeks.
472299|NCT00429169|O2|Outcome|Bupropion|Participants will receive bupropion for 8 weeks
472300|NCT00429169|O1|Outcome|Paroxetine|Participants will receive paroxetine for 8 weeks
472301|NCT00429169|E2|Reported Event|Bupropion|Participants will receive bupropion for 8 weeks
472302|NCT00429169|E1|Reported Event|Paroxetine|Participants will receive paroxetine for 8 weeks
472303|NCT00429143|B1|Baseline|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472304|NCT00429143|P1|Participant Flow|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472305|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472306|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472307|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472308|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472309|NCT00429143|O1|Outcome|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472310|NCT00429143|E1|Reported Event|Haploidentical Allogeneic Transplantation|Patients undergoing hematopoietic stem cell transplant from a partially matched related donor
472311|NCT00429104|B1|Baseline|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
472312|NCT00429104|P1|Participant Flow|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
472313|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
472314|NCT00429104|O1|Outcome|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
472315|NCT00429104|E1|Reported Event|HER2+ Metastatic Breast Cancer|Herceptin 4 mg/kg intravenous (IV) Over 90 Minutes + Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) 250 mcg/m^2 subcutaneously
472316|NCT00429026|B1|Baseline|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
472317|NCT00429026|P1|Participant Flow|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
472318|NCT00429026|O1|Outcome|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
472319|NCT00429026|E1|Reported Event|Conditioning Regimen|Chemotherapy including combinations of Fludarabine, Melphalan, Cyclophosphamide
472320|NCT00428974|B5|Baseline|Total|Total of all reporting groups
472321|NCT00428974|B4|Baseline|Placebo|Oral tablets given every 12 hours for 12 weeks
472322|NCT00428974|B3|Baseline|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
472323|NCT00428974|B2|Baseline|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
472324|NCT00428974|B1|Baseline|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
472325|NCT00428974|P4|Participant Flow|Placebo|Oral tablets given every 12 hours for 12 weeks
472326|NCT00428974|P3|Participant Flow|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
472327|NCT00428974|P2|Participant Flow|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
472328|NCT00428974|P1|Participant Flow|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
472329|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
472330|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
472331|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
472332|NCT00428974|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
472333|NCT00428974|O4|Outcome|Placebo|Oral tablets given every 12 hours for 12 weeks
472334|NCT00428974|O3|Outcome|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
472335|NCT00428974|O2|Outcome|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
472336|NCT00428974|O1|Outcome|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
472337|NCT00428974|E4|Reported Event|Placebo|Oral tablets given every 12 hours for 12 weeks
472338|NCT00428974|E3|Reported Event|CF101 4 mg BID|Oral tablets given every 12 hours for 12 weeks
472339|NCT00428974|E2|Reported Event|CF101 2 mg BID|Oral tablets given every 12 hours for 12 weeks
472340|NCT00428974|E1|Reported Event|CF101 1 mg Twice Daily (BID)|Oral tablets given every 12 hours for 12 weeks
474659|NCT00423332|P2|Participant Flow|Placebo|Placebo / Day: 18 patients randomised
472352|NCT00428597|P1|Participant Flow|Sunitinib|Oral sunitinib 37.5 milligrams (mg) once daily on a continuous daily dosing schedule.
472353|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472354|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472355|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472356|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472357|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472358|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472359|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472360|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472361|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472362|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472363|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472364|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472365|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472366|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472367|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472368|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472369|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472370|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472371|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472372|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472373|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472374|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472375|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472376|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472377|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472378|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472379|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472380|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472381|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472382|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472383|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472384|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472385|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472386|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472387|NCT00428597|O2|Outcome|Placebo|Matching placebo.
472388|NCT00428597|O1|Outcome|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472389|NCT00428597|E2|Reported Event|Placebo|Matching placebo.
472390|NCT00428597|E1|Reported Event|Sunitinib|Oral sunitinib 37.5 mg once daily on a continuous daily dosing schedule.
472391|NCT00428584|B3|Baseline|Total|Total of all reporting groups
472392|NCT00428584|B2|Baseline|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472393|NCT00428584|B1|Baseline|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472394|NCT00428584|P2|Participant Flow|Betaseron|
472395|NCT00428584|P1|Participant Flow|New Formulation of Rebif|The new formulation of rebif is not approved and under investigation in the US
472396|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
472397|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
472398|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
472399|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
472400|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
472401|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
472402|NCT00428584|O2|Outcome|Betaseron to the New Formulation of Rebif|
472403|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, Rebif (New Formulation) 44 mcg, subcutaneous injection, three times a week
472404|NCT00428584|O2|Outcome|Betaseron to New Formulation of Rebif|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472405|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, new formualation of rebif- 44 mcg, subcutaneous injection, three times a week
472406|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472407|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472408|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472409|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472410|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472411|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472412|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472413|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472414|NCT00428584|O2|Outcome|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472415|NCT00428584|O1|Outcome|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472416|NCT00428584|E2|Reported Event|Betaseron|Human interferon beta-1b, Betaseron 250 mcg, subcutaneous injection, every other day
472417|NCT00428584|E1|Reported Event|New Formulation of Rebif|Human interferon beta 1a, (new formulation of rebif) 44 mcg, subcutaneous injection, three times a week
472418|NCT00428441|B1|Baseline|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
472419|NCT00428441|P1|Participant Flow|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
472420|NCT00428441|O1|Outcome|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
472421|NCT00428441|E1|Reported Event|D-dimer Negative|patients with recurrent venous thrombosis and negative D-dimer at the time of enrolment
472422|NCT00428389|B3|Baseline|Total|Total of all reporting groups
472423|NCT00428389|B2|Baseline|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472424|NCT00428389|B1|Baseline|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472425|NCT00428389|P2|Participant Flow|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472426|NCT00428389|P1|Participant Flow|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472427|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472428|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472429|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472430|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
473804|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
472431|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472432|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472433|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472434|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472435|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472436|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472437|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472438|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472439|NCT00428389|O2|Outcome|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472440|NCT00428389|O1|Outcome|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472441|NCT00428389|E2|Reported Event|Delayed Switch|Patients randomized to the delayed switch group were switched to 5 cm^2 rivastigmine patch formulation on Day 8, following a 7-day withdrawal period from donepezil. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472442|NCT00428389|E1|Reported Event|Immediate Switch|Patients randomized to the immediate switch group continued treatment with donepezil through the evening prior to Day 8 of the study. On Day 8, all patients began open-label treatment with 5 cm^2 rivastigmine patch formulation. A new patch was applied daily for 4 weeks. Patients who completed the core phase had the option of entering the extension phase, in which they received open-label treatment with rivastigmine patch formulation for an additional 20 weeks. In the absence of any dose-limiting adverse events (AEs), the dose was increased to 10 cm^2 patch, and it remained the same through Week 25. Patients who experienced dose-limiting AEs had their dose reduced to 5 cm^2 patch and continued on their best tolerated dose for the remainder of the study.
472443|NCT00428246|B4|Baseline|Total|Total of all reporting groups
472444|NCT00428246|B3|Baseline|3|Placebo
472445|NCT00428246|B2|Baseline|2|2 mcg paricalcitol
472446|NCT00428246|B1|Baseline|1|1 mcg paricalcitol
472447|NCT00428246|P3|Participant Flow|3|Placebo
472448|NCT00428246|P2|Participant Flow|2|2 mcg paricalcitol
472449|NCT00428246|P1|Participant Flow|1|1 mcg paricalcitol
472450|NCT00428246|O3|Outcome|3|Placebo
472451|NCT00428246|O2|Outcome|2|2 mcg paricalcitol
472452|NCT00428246|O1|Outcome|1|1 mcg paricalcitol
472453|NCT00428246|E3|Reported Event|3|Placebo
472454|NCT00428246|E2|Reported Event|2|2 mcg paricalcitol
472455|NCT00428246|E1|Reported Event|1|1 mcg paricalcitol
472456|NCT00428220|B1|Baseline|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
472457|NCT00428220|P1|Participant Flow|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
472458|NCT00428220|O11|Outcome|Sunitinib 11|Parent Study: A6181170
472459|NCT00428220|O10|Outcome|Sunitinib 10|Parent Study: A6181126
472460|NCT00428220|O9|Outcome|Sunitinib 9|Parent Study: A6181120
472461|NCT00428220|O8|Outcome|Sunitinib 8|Parent Study: A6181113
472462|NCT00428220|O7|Outcome|Sunitinib 7|Parent Study: A6181112
472463|NCT00428220|O6|Outcome|Sunitinib 6|Parent Study: A6181111
472464|NCT00428220|O5|Outcome|Sunitinib 5|Parent Study: A6181110
472465|NCT00428220|O4|Outcome|Sunitinib 4|Parent Study: A6181107
472466|NCT00428220|O3|Outcome|Sunitinib 3|Parent Study: A6181094
472467|NCT00428220|O2|Outcome|Sunitinib 2|Parent Study: A6181087
472468|NCT00428220|O1|Outcome|Sunitinib 1|Parent Study: A6181078
472469|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
472470|NCT00428220|O1|Outcome|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
472471|NCT00428220|E1|Reported Event|Sunitinib|Participants receiving treatment on single-agent sunitinib on continuous dosing regimens returned for study visits at Day 28, and every 8 weeks thereafter. Participants on regimens other than single-agent sunitinib on continuous dosing followed the schedule of activities from their parent or extension protocol. Sunitinib-naïve participants (ie, those not treated with sunitinib in the previous parent study) received a starting dose of 37.5 mg sunitinib once daily.
472472|NCT00428116|B3|Baseline|Total|Total of all reporting groups
472473|NCT00428116|B2|Baseline|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
472474|NCT00428116|B1|Baseline|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
472475|NCT00428116|P2|Participant Flow|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
472476|NCT00428116|P1|Participant Flow|Continued HAART|After 24 months of HAART, infants were continued on HAART.
472477|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
472478|NCT00428116|O1|Outcome|Continue HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
472479|NCT00428116|O2|Outcome|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
472556|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472480|NCT00428116|O1|Outcome|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
472481|NCT00428116|E2|Reported Event|Interrupted HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to interrupted treatment and followed for 18 months.
472482|NCT00428116|E1|Reported Event|Continued HAART|After 24 months of treatment with HAART, half the eligible infants will be randomized to continued treatment with HAART for 18 months.
472483|NCT00428077|B1|Baseline|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
472484|NCT00428077|P1|Participant Flow|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
472485|NCT00428077|O1|Outcome|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients with Philadelphia Chromosome (Ph+) or Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL),positive Chronic Myeloid Leukemia(CML), in cytogenetic remission, with minimal residual disease.
472486|NCT00428077|E1|Reported Event|Breakpoint Cluster Region-Abelson Murine Leukemia(BCR-ABL)|Patients will be vaccinated 15 times over 12 months with a vaccine comprised of native and synthetic BCR-ABL (break-point cluster region-Abelson murine leukemia) specific peptides and the immunologic adjuvants, Montanide ISA 51-VG.
472487|NCT00427999|B1|Baseline|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472488|NCT00427999|P1|Participant Flow|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472489|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472490|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472491|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472492|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472493|NCT00427999|O1|Outcome|STI571+ Pioglitazone+ Etoricoxib + Dexamethasone + Treosulfane|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks
472494|NCT00427999|E2|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Ext)|Extension follow-up
472495|NCT00427999|E1|Reported Event|STI571+Pioglitazone+Etoricoxib+Dexamethasone+Treosulfane(Core)|STI571 (imatinib) 400mg po daily + pioglitazone 60mg po daily + etoricoxib 60mg po daily + dexamethasone 1mg po daily + treosulfane 500mg po daily for 24 weeks (Core)
472496|NCT00427973|B1|Baseline|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472497|NCT00427973|P1|Participant Flow|Singe Arm Open Label Study With AZD2171 at 30 mg Daily.|Patients will receive AZD2171 by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies.
472498|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472499|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472500|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472501|NCT00427973|O1|Outcome|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472502|NCT00427973|E1|Reported Event|Singe Arm Open Label Study With AZD2171 at 30 mg Daily|"Patients will receive AZD2171 (cediranib maleate) at 30 mg by mouth once a day. Treatment may continue for as long as benefit is shown. Patients will undergo MRI and CT scan of the liver before beginning treatment, 3 days after the first dose of AZD2171, and after finishing course one. Patients will also undergo blood collection periodically for laboratory studies. Laboratory biomarker analysis, computed tomography, dynamic contrast-enhanced magnetic resonance imaging, and pharmacological study will be performed.~cediranib maleate: Given orally~laboratory biomarker analysis~computed tomography~dynamic contrast-enhanced magnetic resonance imaging~pharmacological study"
472503|NCT00427960|B3|Baseline|Total|Total of all reporting groups
472504|NCT00427960|B2|Baseline|Atorvastatin|atorvastatin 10 mg
472505|NCT00427960|B1|Baseline|Rosuvastatin|rosuvastatin 5 mg
472506|NCT00427960|P2|Participant Flow|Atorvastatin|atorvastatin 10 mg
472507|NCT00427960|P1|Participant Flow|Rosuvastatin|rosuvastatin 5 mg
472508|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472509|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472510|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472511|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472512|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472513|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472514|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472515|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472516|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472517|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472518|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472519|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472520|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472521|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472522|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472523|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472524|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472525|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472526|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472527|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472528|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472529|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472530|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472531|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472532|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472533|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472534|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472535|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472536|NCT00427960|O2|Outcome|Atorvastatin|atorvastatin 10 mg
472537|NCT00427960|O1|Outcome|Rosuvastatin|rosuvastatin 5 mg
472538|NCT00427960|E2|Reported Event|Atorvastatin|atorvastatin 10 mg
472539|NCT00427960|E1|Reported Event|Rosuvastatin|rosuvastatin 5 mg
472540|NCT00427934|B5|Baseline|Total|Total of all reporting groups
472541|NCT00427934|B4|Baseline|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472542|NCT00427934|B3|Baseline|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472543|NCT00427934|B2|Baseline|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472544|NCT00427934|B1|Baseline|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472545|NCT00427934|P4|Participant Flow|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472546|NCT00427934|P3|Participant Flow|Maraviroc 300 mg BID (Proof-of-Concept [POC])|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472547|NCT00427934|P2|Participant Flow|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472548|NCT00427934|P1|Participant Flow|Maraviroc 150 mg BID (Pharmacokinetic [PK])|150 mg tablet was administered by mouth twice a day (BID) for 4 weeks with stable weekly doses of methotrexate (MTX).
472549|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472550|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472551|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472552|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472553|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472554|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472555|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472634|NCT00427895|B5|Baseline|Total|Total of all reporting groups
472557|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472558|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472559|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472560|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472561|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472562|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472563|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472564|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472565|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472566|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472567|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472568|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472569|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472570|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472571|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472572|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472573|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472574|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472575|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472576|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472577|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472578|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472579|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472580|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472581|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472582|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472583|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472584|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472585|NCT00427934|O4|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472586|NCT00427934|O3|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472587|NCT00427934|O2|Outcome|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472588|NCT00427934|O1|Outcome|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472589|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472590|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472591|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472592|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472593|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472594|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472595|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472596|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472597|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472598|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472599|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472600|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472601|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472602|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472603|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472604|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472605|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472606|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472607|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472608|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472609|NCT00427934|O2|Outcome|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472610|NCT00427934|O1|Outcome|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472611|NCT00427934|E4|Reported Event|Placebo (POC)|Placebo tablets to match active drug. Two tablets were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472612|NCT00427934|E3|Reported Event|Maraviroc 300 mg BID (POC)|300 mg (Two 150 mg tablets) were administered by mouth BID for 12 weeks with stable weekly doses of MTX.
472613|NCT00427934|E2|Reported Event|Maraviroc 300 mg BID (PK)|300 mg (Two 150 mg tablets) were administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472614|NCT00427934|E1|Reported Event|Maraviroc 150 mg BID (PK)|150 mg tablet was administered by mouth BID for 4 weeks with stable weekly doses of MTX.
472615|NCT00427921|B1|Baseline|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472616|NCT00427921|P1|Participant Flow|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472617|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472618|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472619|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472620|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472621|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472622|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472623|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472624|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472625|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472626|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472627|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472628|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472629|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472630|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472631|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472632|NCT00427921|O1|Outcome|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472633|NCT00427921|E1|Reported Event|40 mg Adalimumab Every Other Week|Induction regimen of adalimumab 160 mg subcutaneous (SC) at Baseline and 80 mg SC at Week 2, followed by maintenance dosing of 40 mg every other week (eow) starting at Week 4
472635|NCT00427895|B4|Baseline|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472636|NCT00427895|B3|Baseline|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472637|NCT00427895|B2|Baseline|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472638|NCT00427895|B1|Baseline|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
472639|NCT00427895|P8|Participant Flow|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
472640|NCT00427895|P7|Participant Flow|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
472641|NCT00427895|P6|Participant Flow|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 23vPS (Vaccination 2) at Year 3 to 4.
472642|NCT00427895|P5|Participant Flow|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received open-label 0.5 mL single dose intramuscularly of 13vPnC (Vaccination 2) at Year 3 to 4.
472643|NCT00427895|P4|Participant Flow|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
472644|NCT00427895|P3|Participant Flow|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1) at baseline.
472645|NCT00427895|P2|Participant Flow|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1) at baseline.
472646|NCT00427895|P1|Participant Flow|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at baseline.
472647|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
472648|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472649|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472650|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
472651|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472652|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1) Year 0.
472653|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1) at Year 0.
472654|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]) at Year 0.
472655|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
472656|NCT00427895|O3|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472657|NCT00427895|O2|Outcome|23vPS/23vPS, Cohort 1|Participants aged 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472658|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
472659|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472660|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose at (Vaccination 1).
472661|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose (Vaccination 1).
472662|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
472663|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
472664|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472665|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472666|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472667|NCT00427895|O4|Outcome|13vPnC/13vPnC, Cohort 2|Participants 50-59 years of age who received 13vPnC at vaccination 1 received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2) at Year 3 to 4.
472816|NCT00426842|O1|Outcome|No-drug|
474660|NCT00423332|P1|Participant Flow|AZD2171 45 mg|AZD2171 45mg/Day: 53 patients randomised
472668|NCT00427895|O3|Outcome|23vPS/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472669|NCT00427895|O2|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472670|NCT00427895|O1|Outcome|13vPnC/13vPnC, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 13vPnC (Vaccination 2 [Vax2]) at Year 3 to 4.
472671|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472672|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472673|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472674|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
472675|NCT00427895|O3|Outcome|23vPs/23vPS, Cohort 1|Participants 60-64 years of age who received 23vPS at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472676|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472677|NCT00427895|O1|Outcome|13vPnC/23vPS, Cohort 1|Participants 60-64 years of age who received 13vPnC at vaccination 1, received a 0.5 mL single dose intramuscularly of open-label 23vPS (Vaccination 2) at Year 3 to 4.
472678|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472679|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
472680|NCT00427895|O4|Outcome|13vPnC, Cohort 3|Participants 18-49 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472681|NCT00427895|O3|Outcome|13vPnC, Cohort 2|Participants 50-59 years of age received 13vPnC administered as a 0.5 mL single dose intramuscularly at (Vaccination 1).
472682|NCT00427895|O2|Outcome|23vPS, Cohort 1|Participants 60-64 years of age received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a 0.5 mL single dose intramuscularly (Vaccination 1).
472683|NCT00427895|O1|Outcome|13vPnC, Cohort 1|Participants 60-64 years of age received 13-valent pneumococcal conjugate vaccine (13vPnC) administered as a 0.5 milliliter (mL) single dose intramuscularly (Vaccination 1 [Vax1]).
472684|NCT00427895|E16|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
472685|NCT00427895|E15|Reported Event|13vPnC, Cohort 3|Participants aged 18-49 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
472686|NCT00427895|E14|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
472687|NCT00427895|E13|Reported Event|13vPnC/13vPnC, Cohort 2|Participants aged 50-59 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
472688|NCT00427895|E12|Reported Event|23vPS/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
472689|NCT00427895|E11|Reported Event|23vPS/23vPS, Cohort 1|Participants aged 60-64 years old who received 23vPS at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
472690|NCT00427895|E10|Reported Event|13vPnC/23vPS: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
472691|NCT00427895|E9|Reported Event|13vPnC/23vPS, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 23vPS at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
472692|NCT00427895|E8|Reported Event|13vPnC/13vPnC: 6 Month Follow-up After Vax 2, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported at 6-month follow-up after vaccination 2.
472693|NCT00427895|E7|Reported Event|13vPnC/13vPnC, Cohort 1|Participants aged 60-64 years old who received 13vPnC at vaccination 1 received a 0.5 mL single dose of open-label 13vPnC at Year 3 to 4 (Vaccination 2), reported after vaccination 2.
472694|NCT00427895|E6|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
472695|NCT00427895|E5|Reported Event|13vPnC, Cohort 2|Participants aged 50-59 years old received 13vPnC administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1. Out of 404 participants vaccinated, 1 participant randomized and vaccinated in error without a consent form, and hence safety data is available for 403 participant.
472696|NCT00427895|E4|Reported Event|23vPS: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
472697|NCT00427895|E3|Reported Event|23vPS, Cohort 1|Participants aged 60-64 years old received 23-valent pneumococcal polysaccharide vaccine (23vPS) administered as a single dose 0.5 mL (Vaccination 1), reported after vaccination 1.
472698|NCT00427895|E2|Reported Event|13vPnC: 6 Month Follow-up After Vax 1, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1), reported at 6-month follow-up.
472699|NCT00427895|E1|Reported Event|13vPnC, Cohort 1|Participants aged 60-64 years old received 13 valent pneumococcal conjugate (13vPnC) administered as a single dose 0.5 mL (Vaccination 1 [Vax1]), reported after vaccination.
472700|NCT00427804|B3|Baseline|Total|Total of all reporting groups
472701|NCT00427804|B2|Baseline|Crohn's Disease|Subjects with stable Crohn's disease
472702|NCT00427804|B1|Baseline|Healthy Control|
472703|NCT00427804|P2|Participant Flow|Crohn's Disease|Subjects with stable Crohn's disease
472704|NCT00427804|P1|Participant Flow|Healthy Control|
472705|NCT00427804|O2|Outcome|Crohn's Disease|Subjects with stable Crohn's disease
472706|NCT00427804|O1|Outcome|Healthy Control|
472707|NCT00427804|E2|Reported Event|Crohn's Disease|Subjects with stable Crohn's disease
472708|NCT00427804|E1|Reported Event|Healthy Control|
472709|NCT00427791|B3|Baseline|Total|Total of all reporting groups
472710|NCT00427791|B2|Baseline|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
472711|NCT00427791|B1|Baseline|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
472712|NCT00427791|P2|Participant Flow|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
472713|NCT00427791|P1|Participant Flow|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
472714|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
472715|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
472716|NCT00427791|O2|Outcome|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
472717|NCT00427791|O1|Outcome|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
472718|NCT00427791|E2|Reported Event|Etoposide + Total Body Irradiation|Etoposide 60 mg/kg IV Daily Over 4 Hours for 1 Day + TBI 3 Gy Daily for 4 Days
472719|NCT00427791|E1|Reported Event|Etoposide + Total Body Irradiation + Rituximab|Etoposide 60 mg/kg intravenous (IV) Daily Over 4 Hours for 1 Day + Total Body Irradiation (TBI) 3 Gy Daily for 4 Days + Rituximab 375 mg/m^2 IV Weekly Over 4-8 Hours for 4 Weeks
472720|NCT00427765|B1|Baseline|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
472721|NCT00427765|P1|Participant Flow|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
472722|NCT00427765|O1|Outcome|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
472723|NCT00427765|E1|Reported Event|Busulfan + Melphalan|Busulfan 32 mg/m^2 intravenous (IV) for 1 Day then 130 mg/m^2 IV for 4 Days; and Melphalan 70 mg/m^2 IV for 2 Days
472724|NCT00427700|B3|Baseline|Total|Total of all reporting groups
472725|NCT00427700|B2|Baseline|Clomiphene|"Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle"
472726|NCT00427700|B1|Baseline|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle"
472727|NCT00427700|P2|Participant Flow|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
472728|NCT00427700|P1|Participant Flow|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
472729|NCT00427700|O2|Outcome|Raloxiphene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
472730|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
472731|NCT00427700|O2|Outcome|Raloxifene|Use of 100mg of raloxifene during days 5-9 of the menstrual cycle
472732|NCT00427700|O1|Outcome|Clomiphene|Uso of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle
472733|NCT00427700|E2|Reported Event|Raloxifene|"Use of 100mg of raloxifene during days 5-9 of the menstrual cycle~raloxifene: 100mg PO on days 5-9 of the menstrual cycle~Two cases: one woman had nausea, and the other woman had nausea, headache, and pelvic pain. All mild"
472734|NCT00427700|E1|Reported Event|Clomiphene Citrate|"Use of 100mg of clomiphene citrate during days 5-9 of the menstrual cycle~clomiphene citrate: 100mg PO on days 5-9 of the menstrual cycle~One woman in the CC group had nausea, headache, and abdominal bloating."
472735|NCT00427661|B1|Baseline|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
472736|NCT00427661|P1|Participant Flow|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
472737|NCT00427661|O1|Outcome|Experimental|Busulfan, Fludarabine, Cyclosporine, MMF
472738|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
472739|NCT00427661|O1|Outcome|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
472740|NCT00427661|E1|Reported Event|AHSC in Severe SCD|The patient population for this study included severe SCD patients, both pediatric and adult, who did not have end-organ failure, and met all of the eligibility criteria.
472741|NCT00427635|B3|Baseline|Total|Total of all reporting groups
472742|NCT00427635|B2|Baseline|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472743|NCT00427635|B1|Baseline|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472744|NCT00427635|P2|Participant Flow|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472745|NCT00427635|P1|Participant Flow|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472746|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472747|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472748|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472749|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472750|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472751|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472752|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472753|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472754|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472755|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472756|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472757|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472758|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472759|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472760|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472761|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472762|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472763|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472764|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472765|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472766|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472767|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472768|NCT00427635|O2|Outcome|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472769|NCT00427635|O1|Outcome|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472770|NCT00427635|E2|Reported Event|Placebo|Placebo once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472771|NCT00427635|E1|Reported Event|Esomeprazole|Esomeprazole 0.5 mg/kg/ day once daily 30 minutes prior to a morning feeding during 15 days by oral gavage (using a nasogastric or orogastric tube) or by nippling.
472772|NCT00427557|B1|Baseline|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
472773|NCT00427557|P1|Participant Flow|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
472774|NCT00427557|O1|Outcome|Fludarabine + Melphalan + Umbilical Cord Blood Unit|Fludarabine 30 mg/m^2 given daily for four days. Melphalan 140 mg/m^2 given for one day. Umbilical Cord Blood Unit given on one day.
472775|NCT00427557|E1|Reported Event|Cellular Therapy With Cord Blood Cells|Fludarabine 30 mg/m^2 intravenous (IV) for 4 Days + Melphalan 140 mg/m^2 IV for 1 Day + Rituximab 375 mg/m^2 IV once weekly + Cord Blood Transplantation + Stem Cell Transplantation Infusion
472817|NCT00426842|E1|Reported Event|All Participants|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
472776|NCT00427349|B1|Baseline|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
472777|NCT00427349|P1|Participant Flow|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
472778|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
472779|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
472780|NCT00427349|O1|Outcome|AMG 706+Octreotide|"Patients receive oral AMG 706 and octreotide acetate intramuscularly once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~AMG 706: AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment.~octreotide: One dose consisted of octreotide-LAR 30 mg administered IM on day 1 of each cycle. The first octreotide-LAR injection would correspond with the first day of AMG 706 and then on day 1 of subsequent cycles."
472781|NCT00427349|E1|Reported Event|MG 706+Octreotide|AMG 706 was administered on a flat scale of mg/day and not by weight or body surface area (BSA). AMG 706 was provided as a 25 mg tablet; the daily dose was 125 mg administered as five 25 mg tablets in the AM. AMG 706 was taken daily without breaks in treatment. Each cycle was defined as 28 days. AMG 706 was started within 7 working days of registration, given on the same day as the octreotide-LAR.
472782|NCT00427336|B1|Baseline|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
472783|NCT00427336|P1|Participant Flow|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
472784|NCT00427336|O1|Outcome|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
472785|NCT00427336|E1|Reported Event|Fludarabine + Cyclophosphamide + ATG|Fludarabine 30 mg/m^2/day by vein (IV), Cyclophosphamide IV 300 mg/m^2/day, ATG (Antithymocyte Globulin) IV 3.75 mg/kg/day
472786|NCT00427037|B3|Baseline|Total|Total of all reporting groups
472787|NCT00427037|B2|Baseline|Cholecalciferol|This is vitamin D3 or Cholecalciferol
472788|NCT00427037|B1|Baseline|Placebo|This is a matching placebo
472789|NCT00427037|P2|Participant Flow|Cholecalciferol|This is vitamin D3 or Cholecalciferol
472790|NCT00427037|P1|Participant Flow|Placebo|This is a matching placebo
472791|NCT00427037|O2|Outcome|Cholecalciferol|This is vitamin D3 or Cholecalciferol
472792|NCT00427037|O1|Outcome|Placebo|This is a matching placebo
472793|NCT00427037|O2|Outcome|Cholecalciferol|"D3~Cholecalciferol: 50,000 IU weekly by mouth"
472794|NCT00427037|O1|Outcome|Placebo|"Placebo~Placebo: identical placebo pill orally by mouth"
472795|NCT00427037|E2|Reported Event|Cholecalciferol|This is vitamin D3 or Cholecalciferol
472796|NCT00427037|E1|Reported Event|Placebo|This is a matching placebo
472797|NCT00427011|B1|Baseline|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472798|NCT00427011|P1|Participant Flow|Perampanel|Subjects entered this open-label extension study from the double-blind core study E2007-A001-214 (NCT00165789), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472861|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472799|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472800|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472801|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472802|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472803|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472804|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472805|NCT00427011|O2|Outcome|Perampanel (Perampanel During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472806|NCT00427011|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472807|NCT00427011|E1|Reported Event|Perampanel|Subjects entered this open-label extension study from the double-blind core study (E2007 A001 214), and included the placebo subjects. During the titration phase (lasting 12 weeks), subjects started on perampanel 2mg once daily for 2 weeks, 4 mg for 2 weeks, 6 mg for 2 weeks and finally, 8 mg until the end of the trial. Subjects remained on the same dose or had their dose reduced to their previously tolerated dose. Subjects were allowed to reduce the dose one or two steps, but only one step was allowed at a visit. Those subjects requiring more than two dose reductions were withdrawn. Subjects who did not tolerate the 2mg dose were discontinued from the study.
472808|NCT00426855|B1|Baseline|Group 1|Bortezomib, Bendamustin, combination chemotherapy in nhl
472809|NCT00426855|P1|Participant Flow|Group 1|Bortezomib, Bendamustine, NHL, combination chemotherapy
472810|NCT00426855|O1|Outcome|Group 1|NHL treated with combination chemotherapy of bendamustin and bortezomib
472811|NCT00426855|E1|Reported Event|Group 1|NHL Patients treated with combination of bendamustine and bortezomib
472812|NCT00426842|B1|Baseline|Arm 1|Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
472813|NCT00426842|P1|Participant Flow|All Participants|All participants underwent a head-up tilt maneuver following no-drug, midodrine 5 mg and midodrine 10 mg, in that order, on seperate study visits. Blood pressure response during HUT following administration of Midodrine Hydrochloride compared with no drug.
472814|NCT00426842|O3|Outcome|Midodrine 10 mg|
472815|NCT00426842|O2|Outcome|Midodrine 5 mg|
472818|NCT00426764|B1|Baseline|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472819|NCT00426764|P1|Participant Flow|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472820|NCT00426764|O6|Outcome|Best ECOG = 4|Participants with a best on study ECOG performance score of 4, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472821|NCT00426764|O5|Outcome|Best ECOG = 3|Participants with a best on study ECOG performance score of 3, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472822|NCT00426764|O4|Outcome|Best ECOG = 2|Participants with a best on study ECOG performance score of 2, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472823|NCT00426764|O3|Outcome|Best ECOG = 1|Participants with a best on study ECOG performance score of 1, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472824|NCT00426764|O2|Outcome|Best ECOG = 0|Participants with a best on study ECOG performance score of 0, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472825|NCT00426764|O1|Outcome|Missing|Participants with a missing best on study ECOG performance score, who received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472826|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472827|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472828|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472829|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472830|NCT00426764|O1|Outcome|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472831|NCT00426764|E1|Reported Event|Romidepsin|Participants received romidepsin 14 mg/m^2 administered intravenously over 4 hours on Days 1, 8, and 15 of a 28-day cycle. Participants continued on monthly cycles of romidepsin. The planned duration of study therapy was 6 cycles. Patients who responded could continue beyond 6 cycles until disease progression or other withdrawal criteria were met. For participants treated for 12 or more cycles, maintenance dosing (2 doses per cycle) was permitted.
472832|NCT00426751|B3|Baseline|Total|Total of all reporting groups
472833|NCT00426751|B2|Baseline|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
474661|NCT00423332|O2|Outcome|Placebo|Placebo/Day
472834|NCT00426751|B1|Baseline|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472835|NCT00426751|P2|Participant Flow|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472836|NCT00426751|P1|Participant Flow|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472837|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472838|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472839|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472840|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472841|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472842|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472843|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472844|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472845|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472846|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472847|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472848|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472849|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472850|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472851|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472852|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472853|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472854|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472855|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472856|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472857|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472858|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472859|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472860|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472862|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472863|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472864|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472865|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472866|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472867|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472868|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472869|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472870|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472871|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472872|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472873|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472874|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472875|NCT00426751|O2|Outcome|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472876|NCT00426751|O1|Outcome|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472877|NCT00426751|E2|Reported Event|Abciximab|Intravenous bolus of 0.25 mg/kg Abciximab followed by continuous intravenous infusion of 0.125 μg/kg/min (maximum 10 μg/min) for 12 hr after PCI
472878|NCT00426751|E1|Reported Event|Eptifibatide|Intravenous bolus of 180 micrograms (µg)/kilogram (kg) Eptifibatide followed immediately by a continuous infusion of 2 µg/kg/minute (min) for 20-24 hours (hr) after the end of percutaneous coronary intervention (PCI), and a second bolus of 180 µg/kg administered 10 min after the first bolus
472879|NCT00426660|B1|Baseline|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472880|NCT00426660|P1|Participant Flow|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472881|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472882|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472883|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472884|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472885|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472886|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472887|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472888|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472889|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472890|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472891|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472892|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472893|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472894|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472895|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472896|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472897|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472898|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472899|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472900|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472901|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472902|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472903|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472904|NCT00426660|O1|Outcome|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472905|NCT00426660|E1|Reported Event|Maraviroc|Maraviroc 150 milligrams (mg) twice daily (BID), 600 mg BID, or 300 mg BID; dose administered depending on concomitant medications in combination with optimized background therapy (OBT) according to local standard of care.
472906|NCT00426556|B5|Baseline|Total|Total of all reporting groups
472907|NCT00426556|B4|Baseline|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472908|NCT00426556|B3|Baseline|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
472909|NCT00426556|B2|Baseline|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472910|NCT00426556|B1|Baseline|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472911|NCT00426556|P4|Participant Flow|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472912|NCT00426556|P3|Participant Flow|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
472913|NCT00426556|P2|Participant Flow|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472914|NCT00426556|P1|Participant Flow|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472915|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472916|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
472917|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472918|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472919|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472920|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
473805|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
472921|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472922|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472923|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472924|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
472925|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472926|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472927|NCT00426556|O4|Outcome|Phase II - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472928|NCT00426556|O3|Outcome|Phase I - RAD001 30mg + PT, Weekly|Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab.
472929|NCT00426556|O2|Outcome|Phase I - RAD001 10mg + PT, Daily|Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472930|NCT00426556|O1|Outcome|Phase I - RAD001 5mg + PT, Daily|Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472931|NCT00426556|E4|Reported Event|Phase II - Everolimus 10mg Daily + PT|Phase II - Daily dosing schedule of Everolimus 10mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472932|NCT00426556|E3|Reported Event|Phase I - Everolimus 30mg Weekly + PT|Phase I - Weekly dosing schedule of Everolimus 30mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472933|NCT00426556|E2|Reported Event|Phase I - Everolimus 10mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472934|NCT00426556|E1|Reported Event|Phase I - Everolimus 5mg Daily + PT|Phase I - Daily dosing schedule of Everolimus 5mg plus Paclitaxel plus Trastuzumab. PT = Paclitaxel & Trastuzumab
472935|NCT00426361|B4|Baseline|Total|Total of all reporting groups
472936|NCT00426361|B3|Baseline|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472937|NCT00426361|B2|Baseline|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472938|NCT00426361|B1|Baseline|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472939|NCT00426361|P3|Participant Flow|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472940|NCT00426361|P2|Participant Flow|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472941|NCT00426361|P1|Participant Flow|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472942|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472943|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472944|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472945|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472946|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472947|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472948|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472949|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472950|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472951|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472952|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472953|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472954|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472955|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472956|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472957|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472958|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472959|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472960|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472961|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472962|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472963|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472964|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472965|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472966|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472967|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472968|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472969|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472970|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472971|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472972|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472973|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472974|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472975|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472976|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472977|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472978|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472979|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472980|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472981|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472982|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472983|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472984|NCT00426361|O3|Outcome|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472985|NCT00426361|O2|Outcome|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472986|NCT00426361|O1|Outcome|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472987|NCT00426361|E3|Reported Event|Boostrix Polio → Cervarix Group|Subjects who received Boostrix™ Polio at Month 0 and GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 1, 2 and 7.
472988|NCT00426361|E2|Reported Event|Cervarix + Boostrix Polio Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6 with co-administration of Boostrix™ Polio at Month 0.
472989|NCT00426361|E1|Reported Event|Cervarix Group|Subjects who received GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Month 0, 1 and 6.
472990|NCT00426283|B3|Baseline|Total|Total of all reporting groups
472991|NCT00426283|B2|Baseline|Placebo 1760 mcg|Placebo : 1760 mcg daily
472992|NCT00426283|B1|Baseline|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
472993|NCT00426283|P2|Participant Flow|Placebo 1760 mcg|Placebo : 1760 mcg daily
472994|NCT00426283|P1|Participant Flow|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
472995|NCT00426283|O2|Outcome|Placebo 1760 mcg|Placebo : 1760 mcg daily
472996|NCT00426283|O1|Outcome|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
472997|NCT00426283|E2|Reported Event|Placebo 1760 mcg|Placebo : 1760 mcg daily
472998|NCT00426283|E1|Reported Event|Flovent 1760 mcg|"Drug~Flovent : 1760 mcg daily"
472999|NCT00426270|B1|Baseline|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473000|NCT00426270|P1|Participant Flow|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473001|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473806|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473002|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473003|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473004|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473005|NCT00426270|O1|Outcome|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473006|NCT00426270|E1|Reported Event|Octagam 10% 1 g/kg/Day|Participants received Octagam 10% (human normal immunoglobulin) 1 g/kg intravenously once a day for 2 days.
473007|NCT00426231|B3|Baseline|Total|Total of all reporting groups
473008|NCT00426231|B2|Baseline|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
473009|NCT00426231|B1|Baseline|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
473010|NCT00426231|P2|Participant Flow|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
473011|NCT00426231|P1|Participant Flow|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
473012|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
473013|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
473014|NCT00426231|O2|Outcome|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
473015|NCT00426231|O1|Outcome|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
473016|NCT00426231|E2|Reported Event|Information Control|"Information control~Information control : Information about medication access programs provided to the participant and their healthcare provider"
473017|NCT00426231|E1|Reported Event|Patient Navigator Intervention|"Patient Navigator intervention~Navigation by a health worker : Help provided by health worker to navigate medication access programs"
473018|NCT00426153|B3|Baseline|Total|Total of all reporting groups
473019|NCT00426153|B2|Baseline|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473020|NCT00426153|B1|Baseline|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473021|NCT00426153|P2|Participant Flow|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473022|NCT00426153|P1|Participant Flow|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473023|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473024|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473025|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473026|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473027|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473028|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473029|NCT00426153|O2|Outcome|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473030|NCT00426153|O1|Outcome|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473031|NCT00426153|E2|Reported Event|Placebo|Participants received an injection of placebo (sham) medication intramuscularly every 28 days (+/- 5 day) for one year
473032|NCT00426153|E1|Reported Event|Octreotide|Participants received Octreotide LAR® Depot injections intramuscularly every 28 days (+/- 5 days) for one year
473033|NCT00425386|B1|Baseline|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473034|NCT00425386|P1|Participant Flow|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473035|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473036|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473037|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473038|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473086|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473039|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473040|NCT00425386|O1|Outcome|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473041|NCT00425386|E1|Reported Event|Sunitinib and Erlotinib|"Erlotinib: Dose Level 0 = 50 mg/day, continuous daily; 0.5= 75 mg/day, continuous daily;~100 mg/day, continuous daily; 1.5= 125 mg/day, continuous daily;~150 mg/day, continuous daily~Sunitinib: 50 mg daily, 4 weeks on, 2 weeks off"
473042|NCT00425373|B10|Baseline|Total|Total of all reporting groups
473043|NCT00425373|B9|Baseline|Placebo|4 tablet and 2 capsule placebos taken once daily
473044|NCT00425373|B8|Baseline|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473045|NCT00425373|B7|Baseline|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473046|NCT00425373|B6|Baseline|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473047|NCT00425373|B5|Baseline|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473048|NCT00425373|B4|Baseline|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473049|NCT00425373|B3|Baseline|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473050|NCT00425373|B2|Baseline|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473051|NCT00425373|B1|Baseline|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473052|NCT00425373|P9|Participant Flow|Placebo|4 tablet and 2 capsule placebos taken once daily
473053|NCT00425373|P8|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473054|NCT00425373|P7|Participant Flow|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473055|NCT00425373|P6|Participant Flow|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473056|NCT00425373|P5|Participant Flow|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473057|NCT00425373|P4|Participant Flow|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473058|NCT00425373|P3|Participant Flow|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473059|NCT00425373|P2|Participant Flow|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473060|NCT00425373|P1|Participant Flow|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473061|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
473062|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473063|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473064|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473065|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473066|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473067|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473068|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473069|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473070|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
473071|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473072|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473073|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473074|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473075|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473076|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473077|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473078|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473079|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
473080|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473081|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473082|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473083|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473084|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473085|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473087|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473088|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
473089|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473090|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473091|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473092|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473093|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473094|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473095|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473096|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473097|NCT00425373|O9|Outcome|Placebo|4 tablet and 2 capsule placebos taken once daily
473098|NCT00425373|O8|Outcome|Amlodipine 5 mg|Amlodipine 5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473099|NCT00425373|O7|Outcome|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473100|NCT00425373|O6|Outcome|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473101|NCT00425373|O5|Outcome|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473102|NCT00425373|O4|Outcome|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473103|NCT00425373|O3|Outcome|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473104|NCT00425373|O2|Outcome|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473105|NCT00425373|O1|Outcome|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473106|NCT00425373|E9|Reported Event|Valsartan + Amlodipine 80/5 mg|Valsartan + amlodipine 80/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473107|NCT00425373|E8|Reported Event|Valsartan + Amlodipine 40/5 mg|Valsartan + amlodipine 40/5mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473108|NCT00425373|E7|Reported Event|Amlodipine 5 mg|Amlodipine 2.5 mg 2 capsules plus 4 tablet placebos taken once daily
473109|NCT00425373|E6|Reported Event|Valsartan + Amlodipine 80/2.5 mg|Valsartan + amlodipine 80/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473110|NCT00425373|E5|Reported Event|Valsartan + Amlodipine 40/2.5 mg|Valsartan + amlodipine 40/2.5 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473111|NCT00425373|E4|Reported Event|Amlodipine 2.5 mg|Amlodipine 2.5 mg capsule plus 4 tablet and 1 capsule placebos taken once daily
473112|NCT00425373|E3|Reported Event|Valsartan 80 mg|Valsartan 80 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473113|NCT00425373|E2|Reported Event|Valsartan 40 mg|Valsartan 40 mg tablet plus 3 tablet and 2 capsule placebos taken once daily
473114|NCT00425373|E1|Reported Event|Placebo|4 tablet and 2 capsule placebos taken once daily
473115|NCT00425308|B3|Baseline|Total|Total of all reporting groups
473116|NCT00425308|B2|Baseline|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473117|NCT00425308|B1|Baseline|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473118|NCT00425308|P2|Participant Flow|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473119|NCT00425308|P1|Participant Flow|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473120|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473121|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473122|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473123|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473124|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
474662|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
473125|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473126|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473127|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473128|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473129|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473130|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473131|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473132|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473133|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473134|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473135|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473136|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473137|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473138|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473139|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473140|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473141|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473142|NCT00425308|O2|Outcome|Enteric-coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473143|NCT00425308|O1|Outcome|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473144|NCT00425308|E2|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Everolimus dose has been adjusted to reach in Group 2, assessment of everolimus dose/trough level (C0), between 6 and 10 ng/ml plus Enteric-Coated Mycophenolate Sodium (EC-MPS) 720 mg/d (360mg the morning and 360 mg the evening) plus steroids
473145|NCT00425308|E1|Reported Event|Cyclosporine|Control Arm: Everolimus dose has been adjusted to reach in Group 1, assessment of everolimus dose/trough level (C0), between 3 and 8 ng/ml plus Cyclosporine in which Group 1 dose adjusted to reach, assessment of Cyclosporine dosage and blood concentration (C2), between 200 and 450 ng/ml plus steroids
473146|NCT00425945|B3|Baseline|Total|Total of all reporting groups
473147|NCT00425945|B2|Baseline|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473196|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473148|NCT00425945|B1|Baseline|Pine Bark Extract|200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily. Pine Bark Extract (Flavangenol�) : Flavangenol 200 mg per day. Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks.
473149|NCT00425945|P2|Participant Flow|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473150|NCT00425945|P1|Participant Flow|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473151|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473152|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473153|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473154|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473155|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473156|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473157|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473158|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473159|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473160|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473161|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473162|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473163|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473164|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473165|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473166|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473167|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473168|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473169|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473807|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473170|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473171|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473172|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473173|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473174|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473175|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473176|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473177|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473178|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473179|NCT00425945|O2|Outcome|Placebo (Net Change)|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473180|NCT00425945|O1|Outcome|Pine Bark Extract (Net Change)|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473181|NCT00425945|O2|Outcome|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473182|NCT00425945|O1|Outcome|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473183|NCT00425945|E2|Reported Event|Placebo|Placebo delivered as four tablets matching the active product; four tablets taken daily orally.
473184|NCT00425945|E1|Reported Event|Pine Bark Extract|"200 mg Flavangenol delivered once per day orally. Flavangenol is a brand of Pine Bark Extract manufactured by Toyo Shinyaku of Saga, Japan. Dosage delivered as four tablets 50 mg each; 4 tablets taken in the morning daily.~Pine Bark Extract (Flavangenol®) : Flavangenol 200 mg per day. Flavangenol is a brand of pine bark extract manufactured by Toyo Shinyaku of Saga, Japan.~Dosage delivered as four tablets, 50 mg per tablet, taken once per day orally for 12 weeks."
473185|NCT00425854|B3|Baseline|Total|Total of all reporting groups
473186|NCT00425854|B2|Baseline|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473187|NCT00425854|B1|Baseline|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473188|NCT00425854|P2|Participant Flow|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473189|NCT00425854|P1|Participant Flow|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473190|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473191|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473192|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473193|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473194|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473195|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473197|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473198|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473199|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473200|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473201|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473202|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473203|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473204|NCT00425854|O2|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473205|NCT00425854|O1|Outcome|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473206|NCT00425854|O1|Outcome|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473207|NCT00425854|E2|Reported Event|Cohort B|Patients with HER2-negative, ER-positive and/or PgR-positive tumours receiving oral dose of Afatinib 50 mg qd
473208|NCT00425854|E1|Reported Event|Cohort A|Patients with human epidermal growth factor 2- (HER2-) negative, oestrogen receptor- (ER-) negative, progesterone- (PgR-) negative tumours (triple negative tumours) receiving oral dose of Afatinib 50 mg once daily (qd)
473209|NCT00425750|B1|Baseline|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473210|NCT00425750|P1|Participant Flow|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473211|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473212|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473213|NCT00425750|O1|Outcome|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473214|NCT00425750|E1|Reported Event|Bortezomib; Docetaxel|Docetaxel will be given first at 40 mg/m2 IV on days 1 and 8 of a 21-day cycle except the first dose is held only on Day 1 of Cycle 1. Immediately afterwards, Bortezomib will be given at 1.6 mg/m2 IV on days 1 and 8 of a 21-day cycle. The first dose is given as a single agent only on Day 1 of Cycle 1.
473215|NCT00425698|B3|Baseline|Total|Total of all reporting groups
473216|NCT00425698|B2|Baseline|Placebo|
473217|NCT00425698|B1|Baseline|Erythropoietin|
473218|NCT00425698|P2|Participant Flow|Placebo|
473219|NCT00425698|P1|Participant Flow|Erythropoietin|
473220|NCT00425698|O2|Outcome|Placebo|
473221|NCT00425698|O1|Outcome|Erythropoietin|
473222|NCT00425698|E2|Reported Event|Placebo|
473223|NCT00425698|E1|Reported Event|Erythropoietin|
473224|NCT00425503|B1|Baseline|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
473225|NCT00425503|P1|Participant Flow|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
473226|NCT00425503|O1|Outcome|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
473227|NCT00425503|E1|Reported Event|PS-341|Patients will receive one (1) four (4) week cycle of weekly IV PS-341 followed by a standard of care radical prostatectomy 24 to 72 hours later.
473228|NCT00425438|B3|Baseline|Total|Total of all reporting groups
473229|NCT00425438|B2|Baseline|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473272|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473308|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
474663|NCT00423332|O2|Outcome|Placebo|Placebo/Day
473230|NCT00425438|B1|Baseline|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473231|NCT00425438|P2|Participant Flow|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 grams per square meter (g/m^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473232|NCT00425438|P1|Participant Flow|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473233|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473234|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473235|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473236|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473237|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473238|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473239|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473240|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
474664|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
473241|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473242|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473243|NCT00425438|O2|Outcome|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473244|NCT00425438|O1|Outcome|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473245|NCT00425438|E2|Reported Event|Cyclophosphamide, Azathioprine|Participants received cyclophosphamide 0.75 g/m^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m^2, IV, to maintain a minimum WBC count of 2500/mm^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473246|NCT00425438|E1|Reported Event|Mycophenolate Mofetil|Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
473247|NCT00425269|B3|Baseline|Total|Total of all reporting groups
473248|NCT00425269|B2|Baseline|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
473249|NCT00425269|B1|Baseline|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473250|NCT00425269|P2|Participant Flow|Control|Control Group (n 97) The women in the control group received one group teaching with the main points after the follow-up tests.
473251|NCT00425269|P1|Participant Flow|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473252|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473253|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473254|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473290|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473386|NCT00425061|P3|Participant Flow|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473387|NCT00425061|P2|Participant Flow|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
474665|NCT00423332|O2|Outcome|Placebo|Placebo/Day
473255|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473256|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473257|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473258|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473259|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473260|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473261|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473262|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473263|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473264|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473265|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473266|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473267|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473268|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473269|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473270|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473271|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473273|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473274|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473275|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473276|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473277|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473278|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473279|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473280|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473281|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473282|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473283|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473284|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473285|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473286|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473287|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473288|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473289|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473291|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473292|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473293|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473294|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473295|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473296|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473297|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473298|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473299|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473300|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473301|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473302|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473303|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473304|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473305|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473306|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473307|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473309|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473310|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473311|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473312|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473313|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473314|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473315|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473316|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473317|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473318|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473319|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473320|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473321|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473322|NCT00425269|O2|Outcome|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473323|NCT00425269|O1|Outcome|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473324|NCT00425269|E2|Reported Event|Control|Control Group (n 97) The women in the control group recieved one group teaching with the main points after the follow-up tests.
473388|NCT00425061|P1|Participant Flow|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473389|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473390|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473808|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473325|NCT00425269|E1|Reported Event|Intervention|"Intervention Group (n 101) The women in the intervention group was divided into nine subgroups of 10–12 women. Each subgroup had six group sessions, lasting 2 h each, during the 7 ± 1 month of the intervention.~The group sessions were focused on the importance of diet and physical activity for blood glucose regulation. They aimed at helping the women to incorporate the knowledge acquired into their everyday lives, and to help the women obtaining positive expectancies for lifestyle changes. Culturally adapted materials were used and discussions were encouraged. All the teaching was translated into Punjabi, the preferred language of the participants."
473326|NCT00425113|B3|Baseline|Total|Total of all reporting groups
473327|NCT00425113|B2|Baseline|Placebo|
473328|NCT00425113|B1|Baseline|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
473329|NCT00425113|P2|Participant Flow|Placebo|
473330|NCT00425113|P1|Participant Flow|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
473331|NCT00425113|O2|Outcome|Placebo|
473332|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
473333|NCT00425113|O2|Outcome|Placebo|
473334|NCT00425113|O1|Outcome|Metronidazole|Subjects were randomized to receive metronidazole 500 mg three times daily or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
473335|NCT00425113|E2|Reported Event|Placebo|
473336|NCT00425113|E1|Reported Event|Metronidazole|Subjects were randomized to receive metronidazole 500 mg TID or placebo for 8 weeks, in addition to an individualized background TB treatment regimen. Total duration of treatment was about 18 months following sputum culture conversion.
473337|NCT00425100|B1|Baseline|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
473338|NCT00425100|P1|Participant Flow|Open Label-fesoterodine|All enrolled subjects were treated with fesoterodine 4 mg once daily (QD) for 4 weeks followed by either 4 mg QD or 8 mg QD for the remaining 8 weeks of the study.
473339|NCT00425100|O1|Outcome|Open Label Week 12|
473340|NCT00425100|O2|Outcome|Open Label Week 12|
473341|NCT00425100|O1|Outcome|Open Label Baseline|
473342|NCT00425100|O1|Outcome|Open Label Week 12|
473343|NCT00425100|O2|Outcome|Open Label Week 12|
473344|NCT00425100|O1|Outcome|Open Label Baseline|
473345|NCT00425100|O2|Outcome|Open Label Week 12|
473346|NCT00425100|O1|Outcome|Open Label Baseline|
473347|NCT00425100|O2|Outcome|Open Label Week 12|
473348|NCT00425100|O1|Outcome|Open Label Baseline|
473349|NCT00425100|O2|Outcome|Open Label Week 12|
473350|NCT00425100|O1|Outcome|Open Label Baseline|
473351|NCT00425100|O2|Outcome|Open Label Week 12|
473352|NCT00425100|O1|Outcome|Open Label Baseline|
473353|NCT00425100|O2|Outcome|Open Label Week 12|
473354|NCT00425100|O1|Outcome|Open Label Baseline|
473355|NCT00425100|O1|Outcome|Open Label Week 12|
473356|NCT00425100|O2|Outcome|Open Label Week 12|
473357|NCT00425100|O1|Outcome|Open Label Baseline|
473358|NCT00425100|O1|Outcome|Open Label Week 12|
473359|NCT00425100|O2|Outcome|Open Label Week 12|
473360|NCT00425100|O1|Outcome|Open Label Baseline|
473361|NCT00425100|O2|Outcome|Open Label Week 12|
473362|NCT00425100|O1|Outcome|Open Label Baseline|
473363|NCT00425100|O2|Outcome|Open Label Week 12|
473364|NCT00425100|O1|Outcome|Open Label Baseline|
473365|NCT00425100|O2|Outcome|Open Label Week 12|
473366|NCT00425100|O1|Outcome|Open Label Baseline|
473367|NCT00425100|O1|Outcome|Open Label Week 12|
473368|NCT00425100|O2|Outcome|Open Label Week 12|
473369|NCT00425100|O1|Outcome|Open Label Baseline|
473370|NCT00425100|O2|Outcome|Open Label Week 12|
473371|NCT00425100|O1|Outcome|Open Label Baseline|
473372|NCT00425100|O2|Outcome|Open Label Week 12|
473373|NCT00425100|O1|Outcome|Open Label Baseline|
473374|NCT00425061|B8|Baseline|Total|Total of all reporting groups
473375|NCT00425061|B7|Baseline|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473376|NCT00425061|B6|Baseline|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473377|NCT00425061|B5|Baseline|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473378|NCT00425061|B4|Baseline|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473379|NCT00425061|B3|Baseline|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473380|NCT00425061|B2|Baseline|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473381|NCT00425061|B1|Baseline|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473382|NCT00425061|P7|Participant Flow|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473383|NCT00425061|P6|Participant Flow|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473384|NCT00425061|P5|Participant Flow|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473385|NCT00425061|P4|Participant Flow|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
474666|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
473391|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473392|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473393|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473394|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473395|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473396|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473397|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473398|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473399|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473400|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473401|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473402|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473403|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473404|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473405|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473406|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473407|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473408|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473409|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473410|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473411|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473412|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473413|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473414|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473415|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473416|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473417|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473418|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473419|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473420|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473421|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473422|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473423|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473424|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473425|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473426|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473427|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473428|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473429|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473430|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473431|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473432|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473433|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473434|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473435|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
474667|NCT00423332|O2|Outcome|Placebo|Placebo/Day
473436|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473437|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473438|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473439|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473440|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473441|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473442|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473443|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473444|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473445|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473446|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473447|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473448|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473449|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473450|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473451|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473452|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473453|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473454|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473455|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473456|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473457|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473458|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473459|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473460|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473461|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473462|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473463|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473464|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473465|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473466|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473467|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473468|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473469|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473470|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473471|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473472|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473473|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473474|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473475|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473476|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473477|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473478|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473479|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473480|NCT00425061|O2|Outcome|Placebo|Included all participants who received placebo matched to IMA-638 subcutaneous injection during Stage 1, 2 or 3.
474668|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
473481|NCT00425061|O1|Outcome|IMA-638|Included participants who received any dose of IMA-638 subcutaneous injection during Stage 1, 2 or 3.
473482|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473483|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473484|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473485|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473486|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473487|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473488|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473489|NCT00425061|O3|Outcome|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473490|NCT00425061|O2|Outcome|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473491|NCT00425061|O1|Outcome|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473492|NCT00425061|O4|Outcome|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473493|NCT00425061|O3|Outcome|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473494|NCT00425061|O2|Outcome|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473495|NCT00425061|O1|Outcome|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473496|NCT00425061|E7|Reported Event|Placebo: Stage 2 and 3|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473497|NCT00425061|E6|Reported Event|IMA-638 75 mg: Stage 3|IMA-638 75 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 3.
473498|NCT00425061|E5|Reported Event|IMA-638 200 mg: Stage 2 and 3|IMA-638 200 milligram subcutaneous injection on Day 1, 8, 28, 42, 56, 70 and 84 during Stage 2 and 3.
473499|NCT00425061|E4|Reported Event|Placebo: Stage 1|Placebo matched to IMA-638 subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473500|NCT00425061|E3|Reported Event|IMA-638 2 mg/kg: Stage-1|IMA-638 2 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473501|NCT00425061|E2|Reported Event|IMA-638 0.6 mg/kg: Stage 1|IMA-638 0.6 mg/kg subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473502|NCT00425061|E1|Reported Event|IMA-638 0.2 mg/kg: Stage 1|IMA-638 0.2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1, 8, 28, 56 and 84 during Stage 1.
473503|NCT00424775|B1|Baseline|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473504|NCT00424775|P2|Participant Flow|Vorinostat (400 mg)|This group includes data from all participants who are treated with vorinostat 400 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle. However, no participants received vorinostat 400 mg once daily due to early discontinuation of the study based on the dose limited toxicity on vorinostat 300 mg once daily.
473505|NCT00424775|P1|Participant Flow|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest in the first cycle or 7 days of rest in the second or later cycle.
473506|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473507|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473508|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473509|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473510|NCT00424775|O1|Outcome|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473511|NCT00424775|E1|Reported Event|Vorinostat (300 mg)|This group includes data from all participants who were treated with vorinostat 300 mg once daily consecutive days (14 days) followed by 11 days of rest (first cycle).
473512|NCT00424762|B3|Baseline|Total|Total of all reporting groups
473513|NCT00424762|B2|Baseline|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473514|NCT00424762|B1|Baseline|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473515|NCT00424762|P2|Participant Flow|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473516|NCT00424762|P1|Participant Flow|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473517|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473518|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473519|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473520|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473801|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473521|NCT00424762|O2|Outcome|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473522|NCT00424762|O1|Outcome|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473523|NCT00424762|E2|Reported Event|Placebo|blinded placebo treatment matching 4mg placebo tablet oral once daily titrated to 8mg matching placebo tablet oral once daily
473524|NCT00424762|E1|Reported Event|Rosiglitazone|4mg oral tablet once daily titrated to 8mg oral tablet once daily
473525|NCT00424749|B1|Baseline|Rituximab|375 mg/m^2/week for 4 weeks
473526|NCT00424749|P1|Participant Flow|Rituximab|375 mg/m^2/week for 4 weeks
473527|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
473528|NCT00424749|O1|Outcome|Rituximab|The remission induction regimen included oral prednisone and rituximab. Prednisone was started at 1 mg/kg/day for 4 weeks followed by a taper to 0 mg by 6 months. Rituximab 375 mg/m2 intravenously, once a week for 4 weeks was given within 2 weeks of starting steroid therapy.
473529|NCT00424749|E1|Reported Event|Rituximab|375 mg/m^2/week for 4 weeks
473530|NCT00424645|B3|Baseline|Total|Total of all reporting groups
473531|NCT00424645|B2|Baseline|Placebo|Placebo administered IV following Voraxaze arm.
473532|NCT00424645|B1|Baseline|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
473533|NCT00424645|P2|Participant Flow|Placebo|Placebo administered IV following Voraxaze arm.
473534|NCT00424645|P1|Participant Flow|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
473535|NCT00424645|O2|Outcome|Placebo|Placebo administered IV following Voraxaze arm.
473536|NCT00424645|O1|Outcome|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
473537|NCT00424645|E2|Reported Event|Placebo|Placebo administered IV following Voraxaze arm.
473538|NCT00424645|E1|Reported Event|Voraxaze|Voraxaze administered 50 units/kg intravenously (IV) repeated a maximum of 2 times in a given cycle of chemotherapy.
473539|NCT00424632|B3|Baseline|Total|Total of all reporting groups
473540|NCT00424632|B2|Baseline|PF-03814735 (Schedule B)|Participants received daily dosing of PF-03814735 of 40, 50, or 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473541|NCT00424632|B1|Baseline|PF-03814735 (Schedule A)|Participants received daily dosing of PF-03814735 of 5, 10, 20, 40, 60, 80, or 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473542|NCT00424632|P10|Participant Flow|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473543|NCT00424632|P9|Participant Flow|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473544|NCT00424632|P8|Participant Flow|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473545|NCT00424632|P7|Participant Flow|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473546|NCT00424632|P6|Participant Flow|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473547|NCT00424632|P5|Participant Flow|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473548|NCT00424632|P4|Participant Flow|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473549|NCT00424632|P3|Participant Flow|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473550|NCT00424632|P2|Participant Flow|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473551|NCT00424632|P1|Participant Flow|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473552|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473553|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473554|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473555|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473556|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473557|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473558|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473559|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473560|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473561|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473562|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473563|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473564|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473565|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473566|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473567|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473568|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473569|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473570|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473571|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473572|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473573|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473574|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473575|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473576|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473577|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473578|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473579|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473580|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473581|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473582|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473583|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473584|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473585|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473586|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473802|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473587|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473588|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473589|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473590|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473591|NCT00424632|O1|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473592|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473593|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473594|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473595|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473596|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473597|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473598|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473599|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473600|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473601|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473602|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473603|NCT00424632|O3|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473604|NCT00424632|O2|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473605|NCT00424632|O1|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473606|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473607|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473608|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473609|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473610|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473611|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473612|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473613|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473614|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473615|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473616|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473617|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473618|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473619|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473620|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473621|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473622|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473623|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473624|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473625|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473626|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473627|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473628|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473629|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473630|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473631|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473632|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473633|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473634|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473635|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473636|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473637|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473638|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473639|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473640|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473641|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473642|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473643|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
474669|NCT00423332|O2|Outcome|Placebo|Placebo/Day
473644|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473645|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473646|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473647|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473648|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473649|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473650|NCT00424632|O11|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473651|NCT00424632|O10|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473652|NCT00424632|O9|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473653|NCT00424632|O8|Outcome|PF-03814735 25 mg (Schedule B)|Participant was randomized to receive daily dosing of PF-03814735 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis. However, participant had reduced dose of 25 mg beginning on Cycle 1 Day 1 of treatment.
473654|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473655|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473656|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473657|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473658|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473659|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473660|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473661|NCT00424632|O10|Outcome|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473662|NCT00424632|O9|Outcome|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473663|NCT00424632|O8|Outcome|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473664|NCT00424632|O7|Outcome|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473665|NCT00424632|O6|Outcome|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473666|NCT00424632|O5|Outcome|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473667|NCT00424632|O4|Outcome|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473668|NCT00424632|O3|Outcome|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473669|NCT00424632|O2|Outcome|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473670|NCT00424632|O1|Outcome|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473671|NCT00424632|E10|Reported Event|PF-03814735 60 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473672|NCT00424632|E9|Reported Event|PF-03814735 50 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 50 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
474670|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
473673|NCT00424632|E8|Reported Event|PF-03814735 40 mg (Schedule B)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 10 consecutive days out of 21-day cycles on an outpatient basis.
473674|NCT00424632|E7|Reported Event|PF-03814735 100 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 100 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473675|NCT00424632|E6|Reported Event|PF-03814735 80 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 80 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473676|NCT00424632|E5|Reported Event|PF-03814735 60 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 60 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473677|NCT00424632|E4|Reported Event|PF-03814735 40 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 40 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473678|NCT00424632|E3|Reported Event|PF-03814735 20 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 20 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473679|NCT00424632|E2|Reported Event|PF-03814735 10 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 10 mg administered PO every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473680|NCT00424632|E1|Reported Event|PF-03814735 5 mg (Schedule A)|Participants received daily dosing of PF-03814735 of 5 milligrams (mg) administered orally (PO) every morning on an empty stomach for 5 consecutive days out of 21-day cycles on an outpatient basis.
473681|NCT00424619|B4|Baseline|Total|Total of all reporting groups
473682|NCT00424619|B3|Baseline|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473683|NCT00424619|B2|Baseline|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473684|NCT00424619|B1|Baseline|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473685|NCT00424619|P3|Participant Flow|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473686|NCT00424619|P2|Participant Flow|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473687|NCT00424619|P1|Participant Flow|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473688|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473689|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473690|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473691|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473692|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473693|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473694|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473695|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473696|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473697|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473698|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473699|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473700|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473701|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473702|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473703|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473704|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473705|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473706|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473707|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473708|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473709|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473710|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473711|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473712|NCT00424619|O3|Outcome|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473713|NCT00424619|O2|Outcome|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473714|NCT00424619|O1|Outcome|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473715|NCT00424619|E3|Reported Event|Placebo|Placebo at beginning of study and 1000IU vitamin D3 for 90 days
473716|NCT00424619|E2|Reported Event|100 000 IU Vitamin D2|100 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473717|NCT00424619|E1|Reported Event|50 000 IU Vitamin D2|50 000 IU Vitamin D2 at beginning of study and 1000IU vitamin D3 for 90 days
473718|NCT00424593|B3|Baseline|Total|Total of all reporting groups
473719|NCT00424593|B2|Baseline|Placebo|every day (QD), by mouth (PO), 13 weeks
473803|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
474671|NCT00423332|O2|Outcome|Placebo|Placebo/Day
473720|NCT00424593|B1|Baseline|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473721|NCT00424593|P2|Participant Flow|Placebo|every day (QD), by mouth (PO), 13 weeks
473722|NCT00424593|P1|Participant Flow|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473723|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473724|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473725|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473726|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473727|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473728|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473729|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473730|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473731|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473732|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473733|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473734|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473735|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473736|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473737|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473738|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473739|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473740|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473741|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473742|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473743|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473744|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473745|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473746|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473747|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473748|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473749|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473750|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473751|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473752|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473753|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473754|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473755|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473756|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473757|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473758|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473759|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473760|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473761|NCT00424593|O2|Outcome|Placebo|every day (QD), by mouth (PO), 13 weeks
473762|NCT00424593|O1|Outcome|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473763|NCT00424593|E2|Reported Event|Placebo|every day (QD), by mouth (PO), 13 weeks
473764|NCT00424593|E1|Reported Event|Duloxetine|30 mg, every day (QD), by mouth (PO) for 1 week followed by 60 mg, QD, PO, 6 weeks then 60 mg (responders) or 120 mg (non-responders), QD, PO, 6 weeks during the placebo-controlled phase, then 60 mg or 120 mg, QD, PO, 41 weeks during the extension phase
473765|NCT00424554|B3|Baseline|Total|Total of all reporting groups
473766|NCT00424554|B2|Baseline|No Intervention|No pre-surgery treatment with temozolomide
473767|NCT00424554|B1|Baseline|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473768|NCT00424554|P2|Participant Flow|No Intervention|No pre-surgery treatment with temozolomide
473769|NCT00424554|P1|Participant Flow|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473770|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
473771|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473772|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
473773|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473774|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
473775|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473776|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
473777|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473778|NCT00424554|O2|Outcome|No Intervention|No pre-surgery treatment with temozolomide
473779|NCT00424554|O1|Outcome|Temozolomide (TMZ)|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473780|NCT00424554|E2|Reported Event|No Intervention|No pre-surgery treatment with temozolomide
473781|NCT00424554|E1|Reported Event|Temozolomide|"Temozolomide 75 mg/m^2 daily for 14 days prior to surgery.~As standard of care, it could also have been given at the same dose for up to 28 days after surgery, per investigator discretion."
473782|NCT00424528|B4|Baseline|Total|Total of all reporting groups
473783|NCT00424528|B3|Baseline|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473784|NCT00424528|B2|Baseline|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473785|NCT00424528|B1|Baseline|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473786|NCT00424528|P3|Participant Flow|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473787|NCT00424528|P2|Participant Flow|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473788|NCT00424528|P1|Participant Flow|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473789|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473790|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473791|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473792|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473793|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473794|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473795|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473796|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473797|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473798|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473799|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473800|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473809|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473810|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473811|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473812|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473813|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473814|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473815|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473816|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473817|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473818|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473819|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473820|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473821|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473822|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473823|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473824|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473825|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473826|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473827|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473828|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473829|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473830|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473831|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473832|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473833|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473834|NCT00424528|O3|Outcome|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473835|NCT00424528|O2|Outcome|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473836|NCT00424528|O1|Outcome|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473837|NCT00424528|E3|Reported Event|Arformoterol /Tiotropium|Arformoterol 15 mcg twice daily/Tiotropium 18 mcg once daily
473838|NCT00424528|E2|Reported Event|Tiotropium 18 Mcg Once Daily|Tiotropium 18 mcg once daily/Placebo Inhalation Solution
473839|NCT00424528|E1|Reported Event|Arformoterol 15 Mcg Twice Daily|Arformoterol 15 mcg twice daily/Placebo Inhalation Powder
473840|NCT00424515|B3|Baseline|Total|Total of all reporting groups
473841|NCT00424515|B2|Baseline|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473842|NCT00424515|B1|Baseline|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473843|NCT00424515|P2|Participant Flow|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473844|NCT00424515|P1|Participant Flow|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473845|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473846|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473847|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473882|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473883|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473848|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473849|NCT00424515|O2|Outcome|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473850|NCT00424515|O1|Outcome|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473851|NCT00424515|E2|Reported Event|Mutated KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473852|NCT00424515|E1|Reported Event|Amplified KIT|Imatinib was given at a dose of 400 mg orally daily (4 100 mg pills). Patients received treatment up to 12 months as long as they were receiving clinical benefit. Dosage may have been increased to twice daily if disease worsened and patient was in otherwise good clinical condition. Patients were classified into two cohorts based upon KIT molecular status.
473853|NCT00424502|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473854|NCT00424502|P1|Participant Flow|Rituximab 1000 Milligrams (mg)|Participants received rituximab 1000 mg intravenously (IV) and methylprednisolone 100 mg IV on Days 0 and 14.
473855|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473856|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473857|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473858|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473859|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473860|NCT00424502|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473861|NCT00424502|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg IV and methylprednisolone 100 mg IV on Days 0 and 14.
473862|NCT00424476|B4|Baseline|Total|Total of all reporting groups
473863|NCT00424476|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473864|NCT00424476|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473865|NCT00424476|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473866|NCT00424476|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473867|NCT00424476|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473868|NCT00424476|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473869|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473870|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473871|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473872|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473873|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473874|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473875|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473876|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473877|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473878|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473879|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473880|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473881|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
474424|NCT00423800|B2|Baseline|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
473884|NCT00424476|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473885|NCT00424476|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473886|NCT00424476|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473887|NCT00424476|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473888|NCT00424476|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473889|NCT00424476|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 48 weeks.
473890|NCT00424398|B4|Baseline|Total|Total of all reporting groups
473891|NCT00424398|B3|Baseline|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473892|NCT00424398|B2|Baseline|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473893|NCT00424398|B1|Baseline|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473894|NCT00424398|P3|Participant Flow|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473895|NCT00424398|P2|Participant Flow|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473896|NCT00424398|P1|Participant Flow|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473897|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473898|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473899|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473900|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473901|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473902|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473903|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473904|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473905|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473906|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473907|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473908|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473909|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473910|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473911|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473912|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473913|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473914|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473915|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473916|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473917|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473918|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473919|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473920|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473921|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473922|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473923|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473924|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473925|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473926|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473927|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473928|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473929|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473930|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473931|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473932|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473933|NCT00424398|O3|Outcome|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473934|NCT00424398|O2|Outcome|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473935|NCT00424398|O1|Outcome|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473936|NCT00424398|E3|Reported Event|Bepotastine Besilate Ophthalmic Solution 1.0%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473937|NCT00424398|E2|Reported Event|Placebo|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473938|NCT00424398|E1|Reported Event|Bepreve (Bepotastine Besilate Ophthalmic Solution) 1.5%|1 drop, both eyes at 3 different time points post-CAC within 3 different time points post-dose, for a total of 9 separate time points
473939|NCT00424385|B1|Baseline|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
473940|NCT00424385|P1|Participant Flow|Imatinib + Sorafenib|"Both drugs, Gleevec + Sorafenib are given to all patients on study. There are 4 potential cohorts. Each will enroll 3 evaluable (patients that complete 2 cycles of treatment) patients. If a Dose Limiting Toxicity is demonstrated in a cohort, an additional 3 evaluable patients can be enrolled in that cohort.~Cohort 0 was 400mg Sorafenib every day (QD)and 300mg of Imatinib QD. Cohort 1 was 400mg Sorafenib two times a day and 300mg QD Imatinib."
473941|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
473942|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0 & 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
473943|NCT00424385|O2|Outcome|Imatinib + Sorafenib Cohort 1|300mg every day (QD) Imatinib + 400mg twice daily (BID)Sorafenib, by mouth
473944|NCT00424385|O1|Outcome|Imatinib + Sorafenib Cohort 0|300mg every day (QD)Imatinib + 400mg every day (QD) Sorafenib, by mouth
473945|NCT00424385|E1|Reported Event|Arm 1|Only 1 arm for the study - this arm gets both drugs, gleevec and sorafenib
473946|NCT00424372|B1|Baseline|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473947|NCT00424372|P1|Participant Flow|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473948|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473949|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
474262|NCT00424021|B1|Baseline|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
473950|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473951|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473952|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473953|NCT00424372|O1|Outcome|Pregabalin|Subjects initiated study drug at 75 mg in the evening of Day 1, and then 75 mg BID (150 mg/day) for 1 week from Day 2. Subsequent dose modifications were based on subjects’ safety and efficacy response and the maximum doses were 150 mg BID (300 mg/day) for subjects with low creatinine clearance (CLcr) (30 < CLcr ≤ 60 mL/min) and 300 mg BID (600 mg/day) for subjects with normal CLcr (CLcr > 60 mL/min).
473954|NCT00424346|B5|Baseline|Total|Total of all reporting groups
473955|NCT00424346|B4|Baseline|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473956|NCT00424346|B3|Baseline|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473957|NCT00424346|B2|Baseline|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473958|NCT00424346|B1|Baseline|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
473959|NCT00424346|P4|Participant Flow|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473960|NCT00424346|P3|Participant Flow|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473961|NCT00424346|P2|Participant Flow|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473962|NCT00424346|P1|Participant Flow|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks. Participants in this treatment group who participated in the Extension Phase are represented in the 'Canakinumab 300 mg q2wk' treatment group in the Extension Phase table below.
473963|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473964|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473965|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473966|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473967|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473968|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473969|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473970|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473971|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473972|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473973|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473974|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473975|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473976|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473977|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473978|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473979|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473980|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473981|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473982|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473983|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473984|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473985|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473986|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473987|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473988|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473989|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473990|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473991|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473992|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473993|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473994|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473995|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473996|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473997|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
473998|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
473999|NCT00424346|O3|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474000|NCT00424346|O2|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474001|NCT00424346|O1|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks. Includes participants who received the 600 mg intravenous loading dose on Day 1 of the Core phase.
474002|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474003|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474004|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474005|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474006|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474007|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474008|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474009|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474010|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474011|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474012|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474013|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474014|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474015|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474016|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474017|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474018|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474019|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474020|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474021|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474022|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474023|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474024|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474025|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474425|NCT00423800|B1|Baseline|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
474672|NCT00423332|O1|Outcome|AZD2171 45 mg|AZD2171 45mg/Day
474026|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474027|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474028|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474029|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474030|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474031|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474032|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474033|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474034|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474035|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474036|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474037|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474038|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474039|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474040|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474041|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474042|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474043|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474044|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474109|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474045|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474046|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474047|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474048|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474049|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474050|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474051|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474052|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474053|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474054|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474055|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474056|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474057|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474058|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474059|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474060|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474061|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474062|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474063|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474217|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474673|NCT00423332|E3|Reported Event|Cediranib OL|Open Label part
474064|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474065|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474066|NCT00424346|O4|Outcome|Placebo|Participants received placebo subcutaneous injections every 2 weeks for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474067|NCT00424346|O3|Outcome|Canakinumab 150 mg q4wk|Participants received canakinumab 150 mg subcutaneous injections every 4 weeks (q4wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474068|NCT00424346|O2|Outcome|Canakinumab 300 mg q2wk|Participants received canakinumab 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg subcutaneous injection every 4 weeks.
474069|NCT00424346|O1|Outcome|Canakinumab 600 mg IV + 300 mg q2wk|Participants received canakinumab 600 mg intravenous (IV) loading dose on Day 1 and 300 mg subcutaneous injections every 2 weeks (q2wk) for 12 weeks in the Core Phase. In the Extension Phase, participants received 300 mg canakinumab every 4 weeks subcutaneously, until a protocol amendment in January 2009 decreased the dose to 150 mg every 4 weeks.
474070|NCT00424346|E4|Reported Event|Placebo|Placebo
474071|NCT00424346|E3|Reported Event|ACZ885 150mg sc q4wk|ACZ885 150mg sc q4wk
474072|NCT00424346|E2|Reported Event|ACZ885 300mg sc q2wk|ACZ885 300mg sc q2wk
474073|NCT00424346|E1|Reported Event|ACZ885 600mg iv + 300mg sc q2wk|ACZ885 600mg iv + 300mg sc q2wk
474074|NCT00424294|B3|Baseline|Total|Total of all reporting groups
474075|NCT00424294|B2|Baseline|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474076|NCT00424294|B1|Baseline|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474077|NCT00424294|P2|Participant Flow|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474078|NCT00424294|P1|Participant Flow|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474079|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474080|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474081|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474082|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474083|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474084|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474085|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474086|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474087|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474218|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474219|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474088|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474089|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474090|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474091|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474092|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474093|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474094|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474095|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474096|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474097|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474098|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474099|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474100|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474101|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474102|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474103|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474104|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474105|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474106|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474107|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474108|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474220|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474110|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474111|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474112|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474113|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474114|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474115|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474116|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474117|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474118|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474119|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474120|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474121|NCT00424294|O2|Outcome|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474122|NCT00424294|O1|Outcome|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474123|NCT00424294|E2|Reported Event|CP-195543 and Celecoxib|CP-195543 capsule 400 mg orally twice daily along with celecoxib capsule 200 mg orally twice daily for 12 weeks. A stable dose of methotrexate >=10 mg/week and <=25 mg/week via oral or parenteral route was continued as background therapy.
474124|NCT00424294|E1|Reported Event|Placebo and Celecoxib|Placebo matched to CP-195543 capsule orally twice daily along with celecoxib capsule 200 milligram (mg) orally twice daily for 12 weeks. A stable dose of methotrexate greater than or equal to (>=) 10 milligram per week (mg/week) and less than or equal to (<=) 25 mg/week via oral or parenteral route was continued as background therapy.
474125|NCT00424268|B3|Baseline|Total|Total of all reporting groups
474126|NCT00424268|B2|Baseline|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474127|NCT00424268|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474128|NCT00424268|P2|Participant Flow|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474129|NCT00424268|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474130|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474131|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474132|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474133|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474134|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474135|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474136|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474137|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474138|NCT00424268|O2|Outcome|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474139|NCT00424268|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474140|NCT00424268|E2|Reported Event|Placebo|Placebo, once daily, oral and tiotropium 18 µg, once daily, inhaled
474141|NCT00424268|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and tiotropium 18 µg, once daily, inhaled
474142|NCT00424255|B3|Baseline|Total|Total of all reporting groups
474143|NCT00424255|B2|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474144|NCT00424255|B1|Baseline|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474145|NCT00424255|P2|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474146|NCT00424255|P1|Participant Flow|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474147|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474148|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474149|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474150|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474151|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474152|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474153|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474221|NCT00424177|E6|Reported Event|All Cycles|Participants who reported an AE anytime during 3 cycles of treatment. A cycle consisted of once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy.
474674|NCT00423332|E2|Reported Event|Placebo DB|Double Blind part
474154|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474155|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474156|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474157|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474158|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474159|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474160|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474161|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474162|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474163|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474164|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474222|NCT00424177|E5|Reported Event|More Than 30 Days After Last Dose|Adverse events >30 days after last dose (Post-therapy)
474223|NCT00424177|E4|Reported Event|More Than 1 to 30 Days After Last Dose|Adverse events >1 to 30 days after last dose (Post-therapy)
474165|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474166|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474167|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474168|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474169|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474170|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474171|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474172|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474173|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474174|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474175|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474224|NCT00424177|E3|Reported Event|Cycle 3|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
474225|NCT00424177|E2|Reported Event|Cycle 2|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
474176|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474177|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474178|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474179|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474180|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474181|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474182|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474183|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474184|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474185|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474186|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474226|NCT00424177|E1|Reported Event|Cycle 1|Participants received once-daily treatment for up to 6 weeks, followed by up to 4 weeks off-therapy
474227|NCT00424047|B3|Baseline|Total|Total of all reporting groups
474675|NCT00423332|E1|Reported Event|Cediranib DB|Double Blind part
474187|NCT00424255|O2|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474188|NCT00424255|O1|Outcome|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474189|NCT00424255|E2|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 mg per oral monotherapy QD for 1 week, followed by radiotherapy of 2 Gy per day for 5 days per week (for a total of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 mg/m^2 IV on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received lapatinib 1500 mg per oral administration QD, followed by maintenance lapatinib 1500 mg per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474190|NCT00424255|E1|Reported Event|Placebo|Participants received placebo per oral monotherapy once daily (QD) for 1 week, followed by radiotherapy of 2 Gray (Gy) per day for 5 days per week (for a total dose of 66 Gy for up to 7 weeks). Participants received concurrent cisplatin 100 milligrams per meters squared (mg/m^2) intravenously (IV) on Days 1, 22, and 43 of radiotherapy. One week prior to the start of chemoradiotherapy, then concurrently for 6 to approximately 7 weeks with chemoradiotherapy, participants received placebo per oral administration QD, followed by maintenance placebo per oral monotherapy QD for up to 1 year or until evidence of disease relapse, whichever was sooner.
474191|NCT00424190|B3|Baseline|Total|Total of all reporting groups
474192|NCT00424190|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
474193|NCT00424190|B1|Baseline|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
474194|NCT00424190|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
474195|NCT00424190|P1|Participant Flow|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
474196|NCT00424190|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
474197|NCT00424190|O1|Outcome|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
474198|NCT00424190|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours
474199|NCT00424190|E1|Reported Event|Ceftaroline Fosamil for Injection|Ceftaroline fosamil 600 mg administered IV over 60 minutes every 12 hours followed by placebo administered over 60 minutes every 12 hours
474200|NCT00424177|B1|Baseline|Overall Study Population|Male and female participants greater than or equal to 18 years of age with previously treated chronic ITP, as defined according to the American Society of Hematology/British Committee for Standards in Hematology guidelines, who had platelet counts between greater than or equal to 20 gi/L and less than or equal to 50 Gi/L, on the Day 1 visit (or within 24 hours prior to dosing on Day 1).
474201|NCT00424177|P1|Participant Flow|Treatment Period|Three cycles of treatment. A cycle is defined as an on-therapy period of up to 6 weeks and an off-therapy period of up to 4 weeks.
474202|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474203|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474204|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474205|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474206|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474207|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474208|NCT00424177|O1|Outcome|Overall Study|
474209|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474210|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474211|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474212|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474213|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474214|NCT00424177|O1|Outcome|Cycle 1|Eltrombopag 50 mg starting dose. Participants whose platelet count was below 50 Gi/L were permitted to increase to eltrombopag 75 mg on or after Day 22.
474215|NCT00424177|O3|Outcome|Cycle 3|Same dose of eltrombopag at which participants completed Cycle 2 (eltrombopag 50 or 75 mg)
474216|NCT00424177|O2|Outcome|Cycle 2|Same dose of eltrombopag at which participants completed Cycle 1 (eltrombopag 50 or 75 mg)
474676|NCT00423319|B3|Baseline|Total|Total of all reporting groups
474228|NCT00424047|B2|Baseline|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474229|NCT00424047|B1|Baseline|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474230|NCT00424047|P2|Participant Flow|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474231|NCT00424047|P1|Participant Flow|Lenalidomide Plus Dexamethasone (Len/Dex)|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474232|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474233|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474234|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474235|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474236|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474237|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474238|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned. After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474239|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474240|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474241|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474242|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474243|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474244|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days. Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474245|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474246|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474247|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474248|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474249|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474250|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle. Pulse dexamethasone 40 mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40 mg PO QD for Days 1-4 every 28 days.~Participants with documented progressive disease were permitted to crossover to receive lenalidomide at the same doses mentioned.~After the study was unblinded in August 2005 participants were given the option to add lenalidomide to their dexamethasone treatment regimen immediately or to add lenalidomide to their dexamethasone therapy at the time of disease progression."
474251|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474252|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474253|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474254|NCT00424047|O2|Outcome|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474255|NCT00424047|O1|Outcome|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Pulse dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474256|NCT00424047|E2|Reported Event|Placebo Plus Dexamethasone|"Placebo PO daily on Days 1 to 28 of each 28 day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28-day cycle for Cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD for Days 1-4 every 28 days."
474257|NCT00424047|E1|Reported Event|Lenalidomide Plus Dexamethasone|"Lenalidomide 25 mg by mouth (PO) daily (QD) on Days 1 to 21 and a matching placebo capsule QD on Days 22 to 28 of each 28-day cycle.~Dexamethasone 40mg PO QD on Days 1-4, 9-12, and 17-20 of each 28 day cycle for cycles 1 through 4. Beginning with Cycle 5, dexamethasone dosing schedule was reduced to 40mg PO QD on Days 1 to 4 every 28 days for the remaining cycles."
474258|NCT00424021|B5|Baseline|Total|Total of all reporting groups
474259|NCT00424021|B4|Baseline|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474260|NCT00424021|B3|Baseline|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474261|NCT00424021|B2|Baseline|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
482369|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
474263|NCT00424021|P4|Participant Flow|10 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474264|NCT00424021|P3|Participant Flow|5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474265|NCT00424021|P2|Participant Flow|2.5 mg|The optimized final dose from the open-label period of AMB 220 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
474266|NCT00424021|P1|Participant Flow|1 mg|The optimized final dose from the open-label period of AMB 220 (given once daily [QD] by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
474267|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474268|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474269|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474270|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474271|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474272|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474273|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of AMB 220 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474274|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474275|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474276|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474277|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474278|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474279|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474280|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474281|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474426|NCT00423800|P2|Participant Flow|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
475299|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
474282|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
474283|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474284|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474285|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474286|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474287|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
474288|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474289|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474290|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474291|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474292|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
474293|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474294|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474295|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474427|NCT00423800|P1|Participant Flow|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
474428|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
474296|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group.
474297|NCT00424021|O1|Outcome|Combined Ambrisentan Treatment|The optimized final dose from the open-label period of NCT00046319 (1, 2.5, 5, or 10 mg once daily by oral administration) was used in this study, with further dose refinement at the investigator's discretion. The small sample size, nonrandomized dose group assignments, and the potential for dose adjustments precluded meaningful comparisons between the dose groups. Therefore, efficacy results are only presented for the combined ambrisentan group. Results are presented using the LOCF imputation.
474298|NCT00424021|O4|Outcome|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474299|NCT00424021|O3|Outcome|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474300|NCT00424021|O2|Outcome|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474301|NCT00424021|O1|Outcome|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator's discretion.
474302|NCT00424021|E4|Reported Event|10 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474303|NCT00424021|E3|Reported Event|5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion. Subjects who completed an optional down-titration period at the end of AMB 220 were re-titrated if their final dose was 5 or 10 mg.
474304|NCT00424021|E2|Reported Event|2.5 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
474305|NCT00424021|E1|Reported Event|1 mg|The optimized final dose from the open-label period of NCT00046319 (given QD by oral administration) was used in this study, with further dose refinement at the investigator’s discretion.
474306|NCT00424008|B3|Baseline|Total|Total of all reporting groups
474307|NCT00424008|B2|Baseline|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474308|NCT00424008|B1|Baseline|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474309|NCT00424008|P2|Participant Flow|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474310|NCT00424008|P1|Participant Flow|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474311|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474312|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474313|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474314|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474315|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474316|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474317|NCT00424008|O2|Outcome|F/SC DPI 250/50 mcg BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474318|NCT00424008|O1|Outcome|MF/F MDI 200/10 mcg BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474319|NCT00424008|E3|Reported Event|F/SC DPI * 250/50 MCG BID|Fluticasone propionate/salmeterol (F/SC) 250/50 mcg Dry Powder Inhaler (DPI) BID
474320|NCT00424008|E2|Reported Event|MF/F MDI * 200/10 MCG * BID|Mometasone furoate 200 mcg and formoterol 10 mcg (MF/F) fixed dose combination taken twice daily (BID) via a metered-dose inhaler (MDI).
474321|NCT00424008|E1|Reported Event|Open-label (OL) MF MDI * 200 MCG BID|Mometasone furoate 200 mcg taken twice daily (BID) via a metered-dose inhaler (MDI).
474322|NCT00423891|B4|Baseline|Total|Total of all reporting groups
474323|NCT00423891|B3|Baseline|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474335|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474324|NCT00423891|B2|Baseline|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474325|NCT00423891|B1|Baseline|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474326|NCT00423891|P3|Participant Flow|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474327|NCT00423891|P2|Participant Flow|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474328|NCT00423891|P1|Participant Flow|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474329|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474330|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474331|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474332|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474333|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474334|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474414|NCT00423813|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
474336|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474337|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474338|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474339|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474340|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474341|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474342|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474343|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474344|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474345|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474346|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474415|NCT00423813|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
474416|NCT00423813|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
474347|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474348|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474349|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474350|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474351|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474352|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474353|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474354|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474355|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474356|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474357|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474417|NCT00423813|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
474418|NCT00423813|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
474419|NCT00423813|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
474358|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474359|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474360|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474361|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474362|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474363|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474364|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474365|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474366|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474367|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474368|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474420|NCT00423813|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
474421|NCT00423813|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
474369|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474370|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474371|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474372|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474373|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474374|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474375|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474376|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474377|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474378|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474379|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474422|NCT00423813|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
474423|NCT00423800|B3|Baseline|Total|Total of all reporting groups
482370|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
474380|NCT00423891|O3|Outcome|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474381|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474382|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474383|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with > 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474384|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474385|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474386|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with < 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474387|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474388|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474389|NCT00423891|O2|Outcome|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474390|NCT00423891|O1|Outcome|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474391|NCT00423891|E3|Reported Event|Nucleoside/Tide Analog (NA) - Experienced (Group C)|Participants who failed previous treatment with any non-ETV nucleoside/tide analog (NA) were included in Group C, starting in 2011. PK assessment was optional to participants in Group C. All participants received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg, QD. Participants who met the specified dosing requirements (at least 1.0 mg/day for NA-experienced participants) and could tolerate swallowing ETV tablets were allowed to choose either formulation. ETV was administered for a maximum of 120 weeks.
474392|NCT00423891|E2|Reported Event|Lamivudine (LVD)-Experienced (Group B)|Participants with greater than (>) 12 weeks of prior LVD therapy were included in Group B. Prior to PK assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (> 6 years to ≤ 12 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, QD and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.030 mg/kg up to 1.0 mg, or ETV tablets, 1.0 mg QD. Following PK analysis, those who met the specified dosing requirements (at least 1.0 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474393|NCT00423891|E1|Reported Event|Lamivudine (LVD)-Naive (Group A)|Participants with less than (<) 1 week of prior LVD therapy and with no LVD therapy within 24 weeks prior to enrollment were included in Group A. Prior to Pharmacokinetic (PK) assessment, Cohort 1 (age ≥ 2 years to ≤ 6 years) and Cohort 2 (>6 years to ≤ 12 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, once a day (QD) and Cohort 3 (age >12 years to ≤18 years) received ETV oral solution, 0.015 mg/kg up to 0.5 mg, or ETV tablets, 0.5 mg, QD. Following PK analysis, those who met the specified dosing requirements (at least 0.5 mg/day) and could tolerate swallowing ETV tablets were allowed to choose either formulation. Entecavir (ETV) was administered for a maximum of 120 weeks.
474394|NCT00423878|B3|Baseline|Total|Total of all reporting groups
474395|NCT00423878|B2|Baseline|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
474396|NCT00423878|B1|Baseline|Switch Group|Participants will switch to aripiprazole.
474397|NCT00423878|P2|Participant Flow|Stay Group|Participants will continue with their current antipsychotic treatment, either olanzapine 5-20 mg/day, quetiapine 200-1200 mg/day, or risperidone 1-16 mg/day.
474398|NCT00423878|P1|Participant Flow|Switch Group|Participants will switch to aripiprazole with a cross-titration from the current antipsychotic over 3-4 weeks. Allowed final dosage range for aripiprazole was 5-30 mg/day.
474399|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
474400|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
474401|NCT00423878|O2|Outcome|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
474402|NCT00423878|O1|Outcome|Switch Group|Participants will switch to aripiprazole.
474403|NCT00423878|E2|Reported Event|Stay Group|Participants will continue treatment with olanzapine, quetiapine, or risperidone.
474404|NCT00423878|E1|Reported Event|Switch Group|Participants will switch to aripiprazole.
474405|NCT00423852|B1|Baseline|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
474406|NCT00423852|P1|Participant Flow|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
474407|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
474408|NCT00423852|O1|Outcome|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
474409|NCT00423852|E1|Reported Event|Chemotherapy With Stem Cell Support|"This is a phase I/II trial of sequential accelerated chemotherapy cycles with paclitaxel/ifosfamide and paclitaxel/ifosfamide and carboplatin administered with G-CSF and PBSC support. During phase I, carboplatin, ifosfamide, and paclitaxel will be dose escalated to determine the MTD. Additional patients will be enrolled in the Phase II portion of the study following the determination of the MTD of Ifosfamide and paclitaxel, to bring the total possible number of patients treated at the MTD to 38.~filgrastim~carboplatin~ifosfamide~paclitaxel~autologous hematopoietic stem cell transplantation~peripheral blood stem cell transplantation"
474410|NCT00423813|B4|Baseline|Total|Total of all reporting groups
474411|NCT00423813|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as 2 equally divided nightly doses
474412|NCT00423813|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as 2 equally divided nightly doses
474413|NCT00423813|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
482371|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
474429|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
474430|NCT00423800|O2|Outcome|Pegetron® - 48 Weeks|Participants are treated for 8 weeks and then randomized to an additional 40 weeks of treatment
474431|NCT00423800|O1|Outcome|Pegetron® - 24 Weeks|Participants are treated for 8 weeks and then randomized to an additional 16 weeks of treatment
474432|NCT00423800|E3|Reported Event|Pegetron® - 48 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 40 weeks of treatment.
474433|NCT00423800|E2|Reported Event|Pegetron® - 24 Weeks|Participants are treated for 8 weeks with Pegetron® and then randomized to an additional 16 weeks of treatment.
474434|NCT00423800|E1|Reported Event|Screen Failures|Two participants on commercial Pegetron® who were screen fails and were never randomized had SAEs. Both SAEs were are reported here.
474435|NCT00423735|B4|Baseline|Total|Total of all reporting groups
474436|NCT00423735|B3|Baseline|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474437|NCT00423735|B2|Baseline|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474438|NCT00423735|B1|Baseline|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
474439|NCT00423735|P3|Participant Flow|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474440|NCT00423735|P2|Participant Flow|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474441|NCT00423735|P1|Participant Flow|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
474442|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474443|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity
474444|NCT00423735|O3|Outcome|Stage 2: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity
474445|NCT00423735|O2|Outcome|Stage 1B: Dasatinib up to 400mg/Day|Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.
474446|NCT00423735|O1|Outcome|Stage 1: Dasatinib 200mg/Day|Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity.
474447|NCT00423735|E2|Reported Event|Stage 1B: Dasatinib up to 400mg/Day|"Patients begin with oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity. Patients could escalate 50mg/day at each new cycle up to 400mg/day if they had not progressed to date and had not experienced dose-limiting toxicity.~dasatinib: Given orally"
474448|NCT00423735|E1|Reported Event|Stage 1: Dasatinib 200mg/Day|"Patients receive oral 100mg dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression and unacceptable toxicity~dasatinib: Given orally"
474449|NCT00423722|B3|Baseline|Total|Total of all reporting groups
474450|NCT00423722|B2|Baseline|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474451|NCT00423722|B1|Baseline|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474452|NCT00423722|P2|Participant Flow|Placebo: Lower Saline|Group 2: Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474453|NCT00423722|P1|Participant Flow|Hydration: Normal Saline (Salt Water)|Group 1: 1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474454|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474455|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474456|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474457|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474458|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474459|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474653|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474460|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474461|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474462|NCT00423722|O2|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474463|NCT00423722|O1|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474464|NCT00423722|O4|Outcome|Placebo (Baseline and Day 7)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474465|NCT00423722|O3|Outcome|Hydration (Baseline and Day 7)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474466|NCT00423722|O2|Outcome|Placebo (Baseline and Day 4)|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474467|NCT00423722|O1|Outcome|Hydration (Baseline and Day 4)|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474468|NCT00423722|O2|Outcome|Placebo|Lower Amount of Normal Saline (salt water); 100 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474469|NCT00423722|O1|Outcome|Hydration|1,000 ml of normal saline (0.9% sodium chloride) parenterally over 4 hours daily.
474470|NCT00423722|E2|Reported Event|Placebo|Change Between Day 4 and Baseline
474471|NCT00423722|E1|Reported Event|Hydration|Change Between Day 4 and Baseline
474472|NCT00423683|B3|Baseline|Total|Total of all reporting groups
474473|NCT00423683|B2|Baseline|1- Arixtra Alone|Arixtra treatment without inferior vena cava filter
474474|NCT00423683|B1|Baseline|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
474475|NCT00423683|P2|Participant Flow|1-Arixtra Alone|Arixtra treatment without inferior vena cava filter
474476|NCT00423683|P1|Participant Flow|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
474477|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
474478|NCT00423683|O1|Outcome|Arm 1 Arixtra|
474479|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
474480|NCT00423683|O1|Outcome|Arm 1 Arixtra|
474481|NCT00423683|O2|Outcome|Arm 2 Arixtra + IVC Filter|
474482|NCT00423683|O1|Outcome|Arm 1 Arixtra|
474483|NCT00423683|O2|Outcome|Arixtra and Filter|
474484|NCT00423683|O1|Outcome|Arixtra|
474485|NCT00423683|E2|Reported Event|Arixtra Alone|Arixtra anti coagulation alone
474486|NCT00423683|E1|Reported Event|2 Arixtra+ Filter|Arixtra subq injection + IVC filter
474487|NCT00423670|B8|Baseline|Total|Total of all reporting groups
474488|NCT00423670|B7|Baseline|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474489|NCT00423670|B6|Baseline|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474490|NCT00423670|B5|Baseline|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474491|NCT00423670|B4|Baseline|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474492|NCT00423670|B3|Baseline|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474493|NCT00423670|B2|Baseline|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474494|NCT00423670|B1|Baseline|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474495|NCT00423670|P8|Participant Flow|Arm 8. PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
474496|NCT00423670|P7|Participant Flow|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474497|NCT00423670|P6|Participant Flow|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474498|NCT00423670|P5|Participant Flow|Arm 5. PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474499|NCT00423670|P4|Participant Flow|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474500|NCT00423670|P3|Participant Flow|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474501|NCT00423670|P2|Participant Flow|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474502|NCT00423670|P1|Participant Flow|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks."
482372|NCT00402987|O4|Outcome|Placebo|
474503|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474504|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474505|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474506|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474507|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474508|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474509|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474510|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474511|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474512|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474513|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474514|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474515|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474516|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474517|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474518|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474519|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474520|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474521|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474522|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474523|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474524|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474525|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474526|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474527|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474528|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474529|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474530|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474531|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474532|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474654|NCT00423358|E2|Reported Event|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
474533|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474534|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474535|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474536|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474537|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474538|NCT00423670|O2|Outcome|Arm 2 and Arm 3. PEG + RBV + BOC (28 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 28 weeks.
474539|NCT00423670|O1|Outcome|Arm 4 and Arm 5. PEG + RBV + BOC (48 Weeks)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) with or without a 4 weeks lead with boceprevir (800 mg TID) for 48 weeks.
474540|NCT00423670|O2|Outcome|Arm 2 and Arm 4. PEG + RBV + BOC|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474541|NCT00423670|O1|Outcome|Arm 3 and Arm 5. PEG + RBV + BOC (From Wk 4)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474542|NCT00423670|O7|Outcome|Arm 7. PEG +Low-dose RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474543|NCT00423670|O6|Outcome|Arm 6. PEG + RBV + BOC for 48 Wks (Part II)|PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474544|NCT00423670|O5|Outcome|Arm 5. PEG + RBV+ BOC (From Wk 4) for 44 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474545|NCT00423670|O4|Outcome|Arm 4. PEG +RBV + BOC for 48 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474546|NCT00423670|O3|Outcome|Arm 3. PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474547|NCT00423670|O2|Outcome|Arm 2. PEG + RBV + BOC for 28 Wks (Part I)|Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474548|NCT00423670|O1|Outcome|Arm 1. PEG +RBV for 48 Wks (Part I)|"PegIntron (1.5 μg/kg QW) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had to receive 24 weeks of PegIntron, ribavirin and boceprevir (800 mg TID) for 24 additional weeks. Total treatment duration was up to 54 weeks."
474549|NCT00423670|E8|Reported Event|PEG + RBV + BOC (From Wk 24) for 48 Wks (Part I)|Arm 8. Participants that started in Arm 1 and had detectable HCV-RNA levels after 24 weeks of treatment had the option of receiving boceprevir (800 mg TID) with PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day). Participants that took the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg TID) for 24 additional weeks constitute Arm 8. The total treatment duration was up to 54 weeks.
474550|NCT00423670|E7|Reported Event|PEG +Low-dose RBV + BOC for 48 Wks (Part II)|Arm 7. PegIntron (1.5 μg/kg QW), ribavirin (400 to 1000 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474551|NCT00423670|E6|Reported Event|PEG + RBV + BOC for 48 Wks (Part II)|Arm 6. PegIntron (1.5 μg/kg QW), ribavirin (800 to 1400 mg/day) and boceprevir (800 mg TID) for up to 48 weeks.
474552|NCT00423670|E5|Reported Event|PEG + RBV + BOC (From Wk 4) for 44 Wks (Part I)|Arm 5. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 44 weeks.
474553|NCT00423670|E4|Reported Event|PEG +RBV + BOC for 48 Wks (Part I)|Arm 4. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 48 weeks.
474554|NCT00423670|E3|Reported Event|PEG + RBV + BOC (From Wk 4) for 24 Wks (Part I)|Arm 3. PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for 4 weeks lead-in followed by boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 24 weeks.
474555|NCT00423670|E2|Reported Event|PEG + RBV + BOC for 28 Wks (Part I)|Arm 2. Boceprevir (800 mg TID) plus PegIntron (1.5 μg/kg QW) and ribavirin (800 to 1400 mg/day) for up to 28 weeks.
474556|NCT00423670|E1|Reported Event|PEG +RBV for 48 Wks (Part I)|"Arm 1. PegIntron (1.5 μg/kg, once weekly [QW]) plus ribavirin (800 to 1400 mg/day) for 48 weeks.~• Participants with detectable HCV-RNA levels after 24 weeks of treatment had the option of crossing over to receive 24 weeks of PegIntron, ribavirin, and boceprevir (800 mg, thrice a day [TID]) for 24 additional weeks. Total treatment duration was up to 54 weeks.~Adverse events for 36 participants after they crossed over to Arm 8 are not included."
474557|NCT00423657|B3|Baseline|Total|Total of all reporting groups
474558|NCT00423657|B2|Baseline|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
474559|NCT00423657|B1|Baseline|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
474560|NCT00423657|P2|Participant Flow|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
474561|NCT00423657|P1|Participant Flow|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
482373|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
474562|NCT00423657|O2|Outcome|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
474563|NCT00423657|O1|Outcome|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
474564|NCT00423657|E2|Reported Event|IV Vancomycin Plus IV Aztreonam|Vancomycin 1 g administered over 60 minutes every 12 hours followed by aztreonam 1 g administered over 60 minutes every 12 hours.
474565|NCT00423657|E1|Reported Event|Ceftaroline for Injection|Ceftaroline fosamil 600 mg administered intravenously over 60 minutes every 12 hours, followed by placebo administered over 60 minutes every 12 hours.
474566|NCT00423605|B1|Baseline|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
474567|NCT00423605|P1|Participant Flow|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
474568|NCT00423605|O1|Outcome|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
474569|NCT00423605|E1|Reported Event|Xyrem 4.5 g to 9.0 g|Xyrem 4.5 g, 6.0 g, 7.5 g, and 9.0 g per night administered orally in two equally divided doses
474570|NCT00423592|B1|Baseline|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474571|NCT00423592|P1|Participant Flow|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474572|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474573|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474574|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474575|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474576|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474577|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474578|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474579|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474580|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474581|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474582|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474583|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474584|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474585|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474586|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474587|NCT00423592|O1|Outcome|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474677|NCT00423319|B2|Baseline|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474588|NCT00423592|E1|Reported Event|Ambrisentan|All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg).
474589|NCT00423579|B3|Baseline|Total|Total of all reporting groups
474590|NCT00423579|B2|Baseline|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
474591|NCT00423579|B1|Baseline|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
474592|NCT00423579|P2|Participant Flow|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
474593|NCT00423579|P1|Participant Flow|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
474594|NCT00423579|O2|Outcome|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
474595|NCT00423579|O1|Outcome|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
474596|NCT00423579|E2|Reported Event|Ezetimibe/Simvastatin Placebo + Simvastatin 40 mg|Subjects in the Intent-to-Treat population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin placebo. The second tablet is simvastatin 40 mg. Subjects will receive a maximum of 6 weeks of treatment.
474597|NCT00423579|E1|Reported Event|Ezetimibe/Simvastatin 10/20 mg + Simvastatin Placebo|Subjects in the Intent-to-Treat Population. Subjects will receive 2 tablets. The first tablet is Ezetimibe/Simvastatin 10/20 mg. The second tablet is simvastatin placebo. Subjects will receive a maximum of 6 weeks of treatment
474598|NCT00423488|B3|Baseline|Total|Total of all reporting groups
474599|NCT00423488|B2|Baseline|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474600|NCT00423488|B1|Baseline|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474601|NCT00423488|P2|Participant Flow|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474602|NCT00423488|P1|Participant Flow|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474603|NCT00423488|O2|Outcome|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474604|NCT00423488|O1|Outcome|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474605|NCT00423488|E2|Reported Event|Ezetimibe Placebo + Simvastatin 40 mg|Participants were instructed to take one ezetimibe placebo tablet and one simvastatin 20-mg tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474606|NCT00423488|E1|Reported Event|Ezetimibe 10 mg + Simvastatin Placebo + Simvastatin 20 mg|Participants were instructed to take one 10-mg ezetimibe tablet and one simvastatin placebo tablet orally in the evening every day for six weeks in addition to their daily, oral, 20-mg simvastatin tablet.
474607|NCT00423449|B1|Baseline|All Participants|Vorinostat + Gemcitabine + Cisplatin
474608|NCT00423449|P5|Participant Flow|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474609|NCT00423449|P4|Participant Flow|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474610|NCT00423449|P3|Participant Flow|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474611|NCT00423449|P2|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474612|NCT00423449|P1|Participant Flow|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474613|NCT00423449|O1|Outcome|All Participants|Vorinostat + Gemcitabine + Cisplatin
474614|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474655|NCT00423358|E1|Reported Event|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474615|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474616|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474617|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474618|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474619|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474620|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474621|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474622|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474623|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474624|NCT00423449|O5|Outcome|Vorinostat 400 14/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 14 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474625|NCT00423449|O4|Outcome|Vorinostat 400 10/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 10 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474626|NCT00423449|O3|Outcome|Vorinostat 400 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 400 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474627|NCT00423449|O2|Outcome|Vorinostat 300 7/21+ Gemcitabine 1250 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1250 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474628|NCT00423449|O1|Outcome|Vorinostat 300 7/21+ Gemcitabine 1000 + Cisplatin|Vorinostat 300 mg given the first 7 days of the 21 day cycle. Gemcitabine 1000 mg/m^2 given on days 3 & 10 of the 21 day cycle. Cisplatin 75 mg/m^2 given on day 3 of th 21 day cycle.
474629|NCT00423449|E5|Reported Event|MK-0683 400 mg 14d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
474630|NCT00423449|E4|Reported Event|MK-0683 400 mg 10d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
474631|NCT00423449|E3|Reported Event|MK-0683 400 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
474632|NCT00423449|E2|Reported Event|MK-0683 300 mg 7d/21d + Gemcitabine 1250 mg/m^2 + Cisplatin|
474633|NCT00423449|E1|Reported Event|MK-0683 300 mg x 7d/21d + Gemcitabine 1000 mg/m^2 + Cisplatin|
474634|NCT00423436|B3|Baseline|Total|Total of all reporting groups
474635|NCT00423436|B2|Baseline|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
474636|NCT00423436|B1|Baseline|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
474637|NCT00423436|P2|Participant Flow|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
474638|NCT00423436|P1|Participant Flow|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
474639|NCT00423436|O2|Outcome|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
474640|NCT00423436|O1|Outcome|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
474641|NCT00423436|E2|Reported Event|IVR Assessment Only|IVR (Phone calls twice weekly) + Questionnaire
474642|NCT00423436|E1|Reported Event|IVR Assessment Plus Triage|Interactive Voice Response Telephone System (IVR) Plus Triage (Participants report symptoms to telephone system and doctor/nurse notified when symptom is severe) + Questionnaire
474643|NCT00423358|B3|Baseline|Total|Total of all reporting groups
474644|NCT00423358|B2|Baseline|Placebo|"matching placebo tablet~placebo: matching placebo"
474645|NCT00423358|B1|Baseline|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474646|NCT00423358|P2|Participant Flow|Placebo|"matching placebo tablet~placebo: matching placebo"
474647|NCT00423358|P1|Participant Flow|Vitamin D|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474648|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
474649|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474650|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
474651|NCT00423358|O1|Outcome|Vitamin D, n=11|"ergocalciferol 50,000 IU Twice monthly~Vitamin D: Ergocalciferol 50,000 IU loading dose then twice monthly for one year"
474652|NCT00423358|O2|Outcome|Placebo, n=11|"matching placebo tablet~placebo: matching placebo"
474656|NCT00423332|B3|Baseline|Total|Total of all reporting groups
474657|NCT00423332|B2|Baseline|Placebo|Placebo/Day
474678|NCT00423319|B1|Baseline|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474679|NCT00423319|P2|Participant Flow|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474680|NCT00423319|P1|Participant Flow|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474681|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474682|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474683|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474684|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474685|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474686|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474687|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474688|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474689|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474690|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474691|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474692|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474693|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474694|NCT00423319|O1|Outcome|Apixiban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474695|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474696|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474697|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474698|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474699|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474700|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474701|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474702|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474703|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474704|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474705|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474706|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474707|NCT00423319|O2|Outcome|Enoxaparin, 40 mg QD Plus Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474708|NCT00423319|O1|Outcome|Apixaban, 2.5 mg BID Plus Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474709|NCT00423319|E2|Reported Event|Enoxaparin, 40 mg QD + Placebo|Participants received enoxaparin, 40 mg QD subcutaneously, and matching apixaban-placebo tablets BID
474710|NCT00423319|E1|Reported Event|Apixaban, 2.5 mg BID + Placebo|Participants received apixaban, 2.5 mg twice daily (BID), as oral tablets, and matching enoxaparin-placebo injection once daily (QD)
474711|NCT00423293|B1|Baseline|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
474712|NCT00423293|P1|Participant Flow|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
474713|NCT00423293|O1|Outcome|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
474714|NCT00423293|E1|Reported Event|5-FU + Mitomycin + IMRT|5-FU + Mitomycin + IMRT
474715|NCT00423267|B3|Baseline|Total|Total of all reporting groups
474716|NCT00423267|B2|Baseline|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474717|NCT00423267|B1|Baseline|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474718|NCT00423267|P2|Participant Flow|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474719|NCT00423267|P1|Participant Flow|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months. One subject from period A declined to participate in the amended protocol and discontinued study treatment after 12 months of study drug administration.
474720|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474721|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474722|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474723|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474724|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474725|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474726|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474727|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg PO (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474728|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474729|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474730|NCT00423267|O2|Outcome|Fluconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Fluconazole 400 mg PO (given as two 200-mg oral encapsulated tablets) administered once daily for 12 months. Fluconazole treatment or placebo only occurred during Period A. Participants in this arm were given posaconazole in Period B.
474731|NCT00423267|O1|Outcome|Posaconazole|Eligible subjects will be stratified at Baseline by disease site (skeletal, lung, or soft tissue) and by immune status (immunocompromised or non-immunocompromised) and will then be randomly assigned to receive Posaconazole 400 mg orally (PO) (oral suspension 40 mg/mL) administered twice daily with meals or oral nutritional supplements for 12 months.
474732|NCT00423267|E3|Reported Event|Posaconazole Period B|
474733|NCT00423267|E2|Reported Event|Fluconazole Period A|
474734|NCT00423267|E1|Reported Event|Posaconazole Period A|
474735|NCT00423189|B4|Baseline|Total|Total of all reporting groups
474736|NCT00423189|B3|Baseline|Arm 3|20% fluence photodynamic therapy - procedure
474737|NCT00423189|B2|Baseline|Arm 2|40% fluence photodynamic therapy - procedure
474738|NCT00423189|B1|Baseline|Arm 1|drug - intravitreal ranibizumab
474739|NCT00423189|P3|Participant Flow|Ranibizumab and 20% Fluence PDT(Procedure)|20% fluence photodynamic therapy - procedure
474740|NCT00423189|P2|Participant Flow|Ranibizumab and 40% Fluence PDT(Procedure)|40% fluence photodynamic therapy - procedure
474741|NCT00423189|P1|Participant Flow|Ranibizumab Only|drug - intravitreal ranibizumab
474742|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab - procedure
474743|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy/combined with ranibizumab - procedure
474744|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
474745|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
474746|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
474747|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
474748|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
474749|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
474750|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
474751|NCT00423189|O3|Outcome|20% Fluence Photodynamic Therapy Combined With Ranibizumab|20% fluence photodynamic therapy combined with ranibizumab- procedure
474752|NCT00423189|O2|Outcome|40% Fluence Photodynamic Therapy Combined With Ranibizumab|40% fluence photodynamic therapy combined with ranibizumab- procedure
474753|NCT00423189|O1|Outcome|Ranibizumab Only|drug - intravitreal ranibizumab
474754|NCT00423189|O3|Outcome|20% Fluence PDT/Ranibizumab|20% Fluence PDT with IVT Ranibizumab
474755|NCT00423189|O2|Outcome|40% Fluence PDT/Ranibizumab|40% Fluence PDT WITH ivt Ranibizumab
474756|NCT00423189|O1|Outcome|Ranibizumab Only|IVT Ranibizumab only
474757|NCT00423189|E3|Reported Event|20% PDT Fluence Combined With Ranibizumab|Subjects who received 20% with as needed ranibizumab
474758|NCT00423189|E2|Reported Event|40% Fluence PDT Combined With Ranibizumab|Subjects who have received 40% fluence PDT combined with as needed dosing with ranibizumab
474759|NCT00423189|E1|Reported Event|Ranibizumab Only|subject only received ranibizumab
474760|NCT00423176|B3|Baseline|Total|Total of all reporting groups
474761|NCT00423176|B2|Baseline|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
474762|NCT00423176|B1|Baseline|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
474763|NCT00423176|P2|Participant Flow|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
474764|NCT00423176|P1|Participant Flow|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
474765|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
474766|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
474767|NCT00423176|O2|Outcome|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
474768|NCT00423176|O1|Outcome|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
474769|NCT00423176|E2|Reported Event|Placebo|Matching placebo nasal spray BID for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID or amoxicillin 2 gm/clavulanic acid 125 mg BID, depending on age).
474770|NCT00423176|E1|Reported Event|Mometasone Furoate Nasal Spray (MFNS)|Mometasone furoate nasal spray (MFNS) twice daily (BID) for 29 days, plus antibiotic for 10 days (amoxicillin 875 mg/clavulanic acid 125 mg BID for participants 12 to 15 years of age or amoxicillin 2 gm/clavulanic acid 125 mg BID for participants 16 years of age or older).
474771|NCT00423150|B1|Baseline|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
474772|NCT00423150|P1|Participant Flow|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
474773|NCT00423150|O1|Outcome|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
474774|NCT00423150|E1|Reported Event|Temozolomide|Temozolomide capsules 150 mg/m^2 daily on a 7-day on/7-day off schedule for each 28-day cycle. Temozolomide is the only treatment group, and and all participants received the same dosing regimen.
474775|NCT00423098|B3|Baseline|Total|Total of all reporting groups
474776|NCT00423098|B2|Baseline|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474842|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474777|NCT00423098|B1|Baseline|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474778|NCT00423098|P2|Participant Flow|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474779|NCT00423098|P1|Participant Flow|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474780|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474781|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474782|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474783|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474784|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474785|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474786|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474787|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474788|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474789|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474790|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
475571|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
474791|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474792|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474793|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474794|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474795|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474796|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474797|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474798|NCT00423098|O2|Outcome|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474799|NCT00423098|O1|Outcome|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474800|NCT00423098|E2|Reported Event|Low Dose|Mycophenolate sodium was administered orally in combination with a reduced dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 0.5 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474801|NCT00423098|E1|Reported Event|Standard Dose|Mycophenolate sodium was administered orally in combination with a standard dose of corticosteroids (CS) administered as prednisone or prednisone equivalent (PRED). Mycophenolate sodium was administered in divided doses at a daily dose of 1440 mg during the first 2 weeks of the study and then at 2160 mg daily for the next 22 weeks. The dose of CS was started at 1 mg per kg body weight and subsequently tapered according to the patient's weight. The planned treatment duration was 24 weeks.
474802|NCT00423085|B4|Baseline|Total|Total of all reporting groups
474803|NCT00423085|B3|Baseline|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474804|NCT00423085|B2|Baseline|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474805|NCT00423085|B1|Baseline|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474843|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
475572|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
474806|NCT00423085|P4|Participant Flow|Open-label Extension|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
474807|NCT00423085|P3|Participant Flow|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474808|NCT00423085|P2|Participant Flow|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474809|NCT00423085|P1|Participant Flow|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474810|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
474811|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
474812|NCT00423085|O1|Outcome|Open-label Extension Arm|"All participants started treatment with a daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and then 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period) for a total of 52 weeks. A predetermined allowed adjustment scheme was followed in participants who required dose adjustment due to low tolerability."
474813|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474814|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474815|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474816|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474817|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474818|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474819|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474820|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474821|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474844|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474937|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474822|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474823|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474824|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474825|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474826|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474827|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474828|NCT00423085|O3|Outcome|Rivastigmine 10 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474829|NCT00423085|O2|Outcome|Rivastigmine 5 cm^2|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and then daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474830|NCT00423085|O1|Outcome|Placebo|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474831|NCT00423085|E4|Reported Event|Open-Label Extension (52 Weeks)|"All participants started treatment with daily rivastigmine 2.5 cm^2 patch. The dose was increased to 5, 7.5, and 10 cm^2 after 4 weeks of treatment at each dose level. One patch was applied once daily. The dose level reached by each individual patient at the end of this 16 weeks was maintained for the rest of the study duration (Maintenance Period). A predetermined allowed adjustment scheme was followed in patients who required dose adjustment due to low tolerability."
474832|NCT00423085|E3|Reported Event|Rivastigmine 10 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks, rivastigmine 5 cm^2 patch for the next 4 weeks, rivastigmine 7.5 cm^2 patch for the next 4 weeks and then rivastigmine 10 cm^2 patch for the final 4 weeks. For patients who experienced intolerability, the dose was adjusted downward. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474833|NCT00423085|E2|Reported Event|Rivastigmine 5 cm^2 (24 Weeks)|During the 16-week titration period patients received daily rivastigmine 2.5 cm^2 patch for the first 4 weeks and thereafter daily rivastigmine 5 cm^2 patch. For patients who experienced intolerability, the dose was adjusted to rivastigmine 2.5 cm^2 daily. Patients then entered the 8-week maintenance period during which time they continued to receive the dose of rivastigmine they were taking at the end of the titration period.
474834|NCT00423085|E1|Reported Event|Placebo (24 Weeks)|Participants received daily matching placebo patch for the duration of the 24-week double-blind treatment phase of the study.
474835|NCT00423046|B3|Baseline|Total|Total of all reporting groups
474836|NCT00423046|B2|Baseline|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474837|NCT00423046|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474838|NCT00423046|P2|Participant Flow|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474839|NCT00423046|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474840|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474841|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474936|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474845|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474846|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474847|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474848|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474849|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474850|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474851|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474852|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474853|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474854|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474855|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474856|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474857|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474858|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474859|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474860|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474861|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474862|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474863|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474864|NCT00423046|O2|Outcome|Gardasil Group|Gardasil Group Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474865|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474866|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474867|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474868|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474869|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474870|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474871|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474872|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474873|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474874|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474875|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474876|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474877|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474878|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474879|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474880|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474881|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474882|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474883|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474884|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474885|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474886|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474887|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474888|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474889|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474890|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474891|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474892|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474893|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474894|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
482374|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
474895|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474896|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474897|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474898|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474899|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474900|NCT00423046|O2|Outcome|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474901|NCT00423046|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474902|NCT00423046|E2|Reported Event|Gardasil Group|Subjects received 3 doses of Gardasil® (Merck's human papillomavirus [HPV] vaccine) at Months 0, 2 and 6 and a dose of placebo at Month 1. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474903|NCT00423046|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals human papillomavirus [HPV] 16/18 vaccine 580299 (CervarixTM) at Months 0, 1 and 6 and a dose of placebo at Month 2. All doses were administered by intramuscular injection in the deltoid muscle of the upper arm.
474904|NCT00422942|B1|Baseline|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474905|NCT00422942|P1|Participant Flow|Rituximab + Methotrexate (MTX)|Participants received rituximab 1000 milligrams (mg) via intravenous (IV) infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or as needed (PRN) if retreatment criteria were not met; premedication with methylprednisolone (MP) 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg per week (mg/week; oral or parenteral) for up to 48 weeks and folate (greater than or equal to [≥]5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474906|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474907|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474908|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474909|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474910|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474911|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474912|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474913|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474914|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474915|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474916|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474917|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474918|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474919|NCT00422942|O1|Outcome|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474920|NCT00422942|E1|Reported Event|Rituximab + MTX|Participants received rituximab 1000 mg via IV infusion on Days 1 and 15 and also on Days 169 and 183 (for those meeting retreatment criteria) or PRN if retreatment criteria were not met; premedication with MP 100 mg IV was administered at least 30 minutes prior to each rituximab infusion. Participants also received MTX 10-25 mg/week (oral or parenteral) for up to 48 weeks and folate (≥5 mg/week) given as either a single weekly dose or as divided dose for up to 48 weeks.
474921|NCT00422903|B3|Baseline|Total|Total of all reporting groups
474922|NCT00422903|B2|Baseline|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery
474923|NCT00422903|B1|Baseline|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474924|NCT00422903|P2|Participant Flow|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474925|NCT00422903|P1|Participant Flow|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474926|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474927|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474928|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474929|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474930|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474931|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474932|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474933|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474934|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474935|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474990|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
474938|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474939|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474940|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474941|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474942|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474943|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474944|NCT00422903|O2|Outcome|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474945|NCT00422903|O1|Outcome|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474946|NCT00422903|E2|Reported Event|Letrozole + Lapatinib|Letrozole tablets in the dose of 2.5 mg plus lapatinib ditosylate monohydrate tablets in the dose of 1500 mg were administered orally once daily for 6 months prior to surgery.
474947|NCT00422903|E1|Reported Event|Letrozole + Placebo|Letrozole tablets in the dose of 2.5 milligrams (mg) plus matching placebo were administered orally once daily for 6 months prior to surgery.
474948|NCT00422734|B3|Baseline|Total|Total of all reporting groups
474949|NCT00422734|B2|Baseline|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474950|NCT00422734|B1|Baseline|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474951|NCT00422734|P2|Participant Flow|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474952|NCT00422734|P1|Participant Flow|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474953|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474954|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474955|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474956|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474957|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474958|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474959|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474960|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474961|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474962|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474963|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474964|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474965|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474966|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474967|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474968|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474969|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474970|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474971|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474972|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474973|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474974|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474975|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474976|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474977|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474978|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474979|NCT00422734|O2|Outcome|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474980|NCT00422734|O1|Outcome|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474981|NCT00422734|E2|Reported Event|Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
474982|NCT00422734|E1|Reported Event|Placebo|Placebo tablet taken by mouth once a day for 12 weeks
474983|NCT00422669|B4|Baseline|Total|Total of all reporting groups
474984|NCT00422669|B3|Baseline|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
474985|NCT00422669|B2|Baseline|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
474986|NCT00422669|B1|Baseline|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
474987|NCT00422669|P3|Participant Flow|Not Randomized|7 of the 205 subjects did not meet inclusion/exclusion criteria.
474988|NCT00422669|P2|Participant Flow|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
474989|NCT00422669|P1|Participant Flow|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
474991|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
474992|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
474993|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
474994|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
474995|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
474996|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
474997|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
474998|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
474999|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
475000|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
475001|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
475002|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
475003|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
475004|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
475005|NCT00422669|O3|Outcome|Not Randomized|7 of the 205 subjects did not meet in/exclusion criteria so they were not randomized.
475006|NCT00422669|O2|Outcome|RV Apical Pacing|Pacing lead is placed at the bottom of the right ventricle of the heart, in the right ventricular apex
475007|NCT00422669|O1|Outcome|RV Mid-Septal Pacing|Pacing lead is placed in the right ventricle at the middle of the muscle separating the right and left sides of the heart
475008|NCT00422669|E1|Reported Event|Subjects With Implant|All 198 subjects with implant were included in this group.
475009|NCT00422656|B1|Baseline|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
475010|NCT00422656|P1|Participant Flow|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
475011|NCT00422656|O1|Outcome|Perifosine Single Arm Study|Daily perifosine at 150mg orally
475012|NCT00422656|E1|Reported Event|Perifosine|This is a one armed study, all participants receive daily perifosine at 150mg orally.
475013|NCT00422513|B3|Baseline|Total|Total of all reporting groups
475014|NCT00422513|B2|Baseline|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475015|NCT00422513|B1|Baseline|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475016|NCT00422513|P2|Participant Flow|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475017|NCT00422513|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms intravenous (iv) monthly, starting dose
475018|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475019|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475020|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475021|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475022|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475023|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475024|NCT00422513|O2|Outcome|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475025|NCT00422513|O1|Outcome|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475026|NCT00422513|E2|Reported Event|Epoetin Alfa|As prescribed, (iv), 3 times weekly
475027|NCT00422513|E1|Reported Event|Methoxy Polyethylene Glycol-epoetin Beta|120-360 micrograms (iv) monthly, starting dose
475028|NCT00422448|B1|Baseline|Nevi|with or without BRAF and NRAS
475029|NCT00422448|P1|Participant Flow|Nevi|with or without BRAF and NRAS
475030|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
475031|NCT00422448|O1|Outcome|Nevi|with or without BRAF and NRAS
475032|NCT00422448|E1|Reported Event|Nevi|with or without BRAF and NRAS
475033|NCT00422422|B1|Baseline|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475034|NCT00422422|P1|Participant Flow|Brivaracetam (ES)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475035|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475573|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475036|NCT00422422|O1|Outcome|Brivaracetam (FAS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475037|NCT00422422|O1|Outcome|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475038|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475039|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475040|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475041|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475042|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475043|NCT00422422|O1|Outcome|Brivaracetam (PPS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475044|NCT00422422|E1|Reported Event|Brivaracetam (SS)|"Brivaracetam (BRV) was given as 2 equally divided oral doses twice daily (bid). The dosage was adjusted as following:~For subjects ≥8 years:~0.4 mg/kg bid for Week 1~0.8 mg/kg bid for Week 2~1.6 mg/kg bid for Week 3~For subjects <8 years:~0.5 mg/kg bid for Week 1~1.0 mg/kg bid for Week 2~2.0 mg/kg bid for Week 3~Down-titration period (up to 2 weeks):~For subjects ≥8 years:~0.8 mg/kg bid for Week 4~0.4 mg/kg bid for Week 5~For subjects <8 years:~1.0 mg/kg bid for Week 4~0.5 mg/kg bid for Week 5"
475045|NCT00422383|B6|Baseline|Total|Total of all reporting groups
475046|NCT00422383|B5|Baseline|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475047|NCT00422383|B4|Baseline|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475048|NCT00422383|B3|Baseline|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475218|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475219|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475049|NCT00422383|B2|Baseline|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475050|NCT00422383|B1|Baseline|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475051|NCT00422383|P5|Participant Flow|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475052|NCT00422383|P4|Participant Flow|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475053|NCT00422383|P3|Participant Flow|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475054|NCT00422383|P2|Participant Flow|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475055|NCT00422383|P1|Participant Flow|Rituximab Low Dose Plus (+) Methotrexate|Participants received rituximab, 0.5 grams (g), intravenously (IV), on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 milligrams (mg), IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 milligrams per milliliter (mg/mL), orally (PO) or parenterally, as prescribed. Participants also received a stable dose of folate greater than or equal to (≥) 5 milligrams per week (mg/week) given either as a single dose or as a divided weekly dose.
475056|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475057|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475058|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475059|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475220|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475060|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parentally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475061|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475062|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475063|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475064|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475065|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475066|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475067|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475068|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475069|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475070|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475221|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475222|NCT00422292|E4|Reported Event|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475071|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475072|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475073|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475074|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475075|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475076|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475077|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475078|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475079|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475080|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475081|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475082|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475223|NCT00422292|E3|Reported Event|Group 3: Menactra® at 12 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475298|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475083|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475084|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475085|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475086|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475087|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475088|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475089|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475090|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475091|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475092|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475093|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475094|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475095|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475096|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475097|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475098|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475099|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475100|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475101|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475102|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475103|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475104|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475105|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475106|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475107|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475108|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475109|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475110|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475111|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475112|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475113|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475114|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475115|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475116|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475117|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475118|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475224|NCT00422292|E2|Reported Event|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Month|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475225|NCT00422292|E1|Reported Event|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475119|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475120|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475121|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475122|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475123|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475124|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475125|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475126|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475127|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475128|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475129|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475130|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475226|NCT00422279|B3|Baseline|Total|Total of all reporting groups
475227|NCT00422279|B2|Baseline|Extraction Sites|bone inductive implants placed in tooth extraction sites
475228|NCT00422279|B1|Baseline|Supralveolar Position|bone inductive implants placed in supraalveolar position
475229|NCT00422279|P2|Participant Flow|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
475131|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475132|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475133|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475134|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475135|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475136|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475137|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475138|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475139|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475140|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475141|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475142|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475230|NCT00422279|P1|Participant Flow|Supraalveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
475231|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants placed in tooth extraction sockets with a total of 2 patients with 4 implants ( two implants in each patient)
475574|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
475143|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475144|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475145|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475146|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475147|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475148|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475149|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475150|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475151|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475152|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475153|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475232|NCT00422279|O1|Outcome|Supraalveloar Postion|bone inductive implants placed in supraalveolar position a total of 2 patients with 4 implants ( two implants in each patient)
475233|NCT00422279|O2|Outcome|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sockets
482375|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
475154|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475155|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475156|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475157|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475158|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475159|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475160|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475161|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475162|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475163|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475164|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475165|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475234|NCT00422279|O1|Outcome|Supra Aleveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
475235|NCT00422279|E2|Reported Event|Extraction Sites|bone inductive implants (Nobel Replace Tapered Groovy) placed in tooth extraction sites
475236|NCT00422279|E1|Reported Event|Supralveolar Position|bone inductive implants (Nobel Replace Tapered Groovy) placed in supraalveolar position
475166|NCT00422383|O2|Outcome|Rituximab Escalated Dose Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475167|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475168|NCT00422383|O5|Outcome|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475169|NCT00422383|O4|Outcome|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475170|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475171|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475172|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475173|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475174|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475175|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475176|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475177|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475237|NCT00422227|B3|Baseline|Total|Total of all reporting groups
482376|NCT00402987|O4|Outcome|Placebo|
475178|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475179|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475180|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475181|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475182|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475183|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475184|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475185|NCT00422383|O3|Outcome|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475186|NCT00422383|O2|Outcome|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475187|NCT00422383|O1|Outcome|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475188|NCT00422383|E5|Reported Event|Rituximab Decreased Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15 and 0.5 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475189|NCT00422383|E4|Reported Event|Rituximab/Placebo + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1 and 15, and a placebo, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose. This treatment group was not part of the planned analysis and was not analyzed for all outcomes measures since they did not receive the planned treatment.
475296|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
475190|NCT00422383|E3|Reported Event|Rituximab High Dose + Methotrexate|Participants received rituximab, 1.0 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475191|NCT00422383|E2|Reported Event|Rituximab Escalated Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1 and 15 and 1.0 g, IV, on Days 168 and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475192|NCT00422383|E1|Reported Event|Rituximab Low Dose + Methotrexate|Participants received rituximab, 0.5 g, IV, on Days 1, 15, 168, and 182. Participants also received methylprednisolone 100 mg, IV, by slow infusion, which was completed at least 30 minutes prior to each infusion of rituximab Days 1, 15, 168, and 182. Participants also received methotrexate 10-25 mg/mL, PO or parenterally, as prescribed by the treating physician and in accordance with the local label. Participants also received a stable dose of folate ≥ 5 mg/week given either as a single dose or as a divided weekly dose.
475193|NCT00422292|B5|Baseline|Total|Total of all reporting groups
475194|NCT00422292|B4|Baseline|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475195|NCT00422292|B3|Baseline|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475196|NCT00422292|B2|Baseline|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475197|NCT00422292|B1|Baseline|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475198|NCT00422292|P4|Participant Flow|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475199|NCT00422292|P3|Participant Flow|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475200|NCT00422292|P2|Participant Flow|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475201|NCT00422292|P1|Participant Flow|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475202|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475203|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475204|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475205|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475206|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475207|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475208|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475209|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475210|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475211|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475212|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475213|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475214|NCT00422292|O4|Outcome|Group 4: MMRV + PCV at 12 Months|Participants who received no vaccination at 9 months of age and measles, mumps, rubella, varicella (MMRV) vaccine plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475215|NCT00422292|O3|Outcome|Group 3: Menactra® at 9 Months; Menactra® + PCV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus pneumococcal conjugate vaccine (PCV) at 12 months of age
475216|NCT00422292|O2|Outcome|Group 2: Menactra® at 9 Months; Menactra® + MMRV at 12 Months|Participants who received Menactra® at 9 months of age and Menactra® plus measles, mumps, rubella, varicella (MMRV or MMR+V) vaccine at 12 months of age
475217|NCT00422292|O1|Outcome|Group 1: Menactra® at 9 and 12 Months|Participants who received only Menactra® vaccination at 9 and 12 months of age
475575|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475238|NCT00422227|B2|Baseline|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475239|NCT00422227|B1|Baseline|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475240|NCT00422227|P2|Participant Flow|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475241|NCT00422227|P1|Participant Flow|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475242|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475243|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475244|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475245|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475246|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475247|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475248|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475249|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475250|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475251|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475252|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475253|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475254|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475255|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475256|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475257|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475258|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475297|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475259|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475260|NCT00422227|O2|Outcome|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475261|NCT00422227|O1|Outcome|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475262|NCT00422227|E2|Reported Event|DMARD/MTX|Methotrexate (MTX) was taken orally once weekly on the same day of the week (as a single dose or 2 divided doses on the same day) at the same dose subjects were taking at the time of screening. The dose and administration of usual disease-modifying antirheumatic drug (DMARD) therapy followed the approved local label or recommendations. Subjects took commercially available MTX and usual DMARD therapy.
475263|NCT00422227|E1|Reported Event|ETN/MTX|Etanercept (ETN) was administered subcutaneous (SC) bi-weekly (BIW) (eg, on Monday and Thursday, Tuesday and Friday, or Wednesday and Saturday). Each dose of ETN was administered as 1 SC injection.
475264|NCT00422201|B1|Baseline|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
475265|NCT00422201|P1|Participant Flow|Single Arm Mifepristone|"Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
475266|NCT00422201|O1|Outcome|Mifepristone|"Single arm. Study medication was administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
475267|NCT00422201|E1|Reported Event|Mifepristone|"Single arm. Study medication was to be administered at a total daily dose of 600 mg (given as one 200 mg tablet tid, per os) starting on the day of inclusion.~This dose was to be maintained during the whole study except in case of suspicion of adrenal insufficiency, in which case the dose was temporally stopped for 2 to 3 days and restarted at a lower dose of 400 mg daily until the end of the study."
475268|NCT00422162|B3|Baseline|Total|Total of all reporting groups
475269|NCT00422162|B2|Baseline|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475270|NCT00422162|B1|Baseline|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475271|NCT00422162|P2|Participant Flow|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475272|NCT00422162|P1|Participant Flow|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475273|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475274|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475275|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475276|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475277|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475278|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475279|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475280|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475281|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475282|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475283|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475284|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475285|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
475286|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
475287|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
475288|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
475289|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
475290|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
475291|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
475292|NCT00422162|O1|Outcome|Duloxetine 60 mg Responders|60mg QD for 8 weeks
475293|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responders|60mg BID for 8 weeks (placebo added at Week 4)
475294|NCT00422162|O3|Outcome|Duloxetine 120 mg Responders|60mg BID for 8 weeks
475295|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responders|60mg QD for 4 weeks then 60mg BID for 4 weeks
475300|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475301|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475302|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475303|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475304|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475305|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
475306|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
475307|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
475308|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
475309|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475310|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475311|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
475312|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
475313|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
475314|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
475315|NCT00422162|O6|Outcome|Duloxetine 120 mg (All)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475316|NCT00422162|O5|Outcome|Duloxetine 60 mg (All)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475317|NCT00422162|O4|Outcome|Duloxetine 120 mg Non-Responder|60mg BID for 8 weeks (placebo added at Week 4)
475318|NCT00422162|O3|Outcome|Duloxetine 120 mg Responder|60mg BID for 8 weeks
475319|NCT00422162|O2|Outcome|Duloxetine 60 mg Non-Responder|60mg QD for 4 weeks then 60mg BID for 4 weeks
475320|NCT00422162|O1|Outcome|Duloxetine 60 mg Responder|60mg QD for 8 weeks
475321|NCT00422162|O2|Outcome|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475322|NCT00422162|O1|Outcome|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475323|NCT00422162|E2|Reported Event|Duloxetine (120 mg)|60mg BID for 8 weeks (placebo added at Week 4 for nonresponders)
475324|NCT00422162|E1|Reported Event|Duloxetine (60 mg)|60mg every day (QD) for 4 weeks, then responders continued on same dose and nonresponders increased to 60mg twice a day (BID) for next 4 weeks
475325|NCT00422097|B7|Baseline|Total|Total of all reporting groups
475326|NCT00422097|B6|Baseline|Ixabepilone, 30 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 30 mg, on Days 1 through 5 every 21 days.
475327|NCT00422097|B5|Baseline|Ixabepilone, 25 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 25 mg, on Days 1 through 5 every 21 days.
475328|NCT00422097|B4|Baseline|Ixabepilone, 20 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 20 mg, on Days 1 through 5 every 21 days.
475329|NCT00422097|B3|Baseline|Ixabepilone, 15 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 15 mg, on Days 1 through 5 every 21 days.
475330|NCT00422097|B2|Baseline|Ixabepilone, 10 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 10 mg, on Days 1 through 5 every 21 days.
475331|NCT00422097|B1|Baseline|Ixabepilone, 5 mg/d|Participants with advanced cancer received daily oral doses of ixabepilone, 5 mg, on Days 1 through 5 every 21 days.
475332|NCT00422097|P8|Participant Flow|Ixabepilone, MTD (25 mg), With Food|Cohort opened for Cycle 2, after ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, once daily in an oral dose on Days 1 through 5. On all dosing days in Cycle 1, participants fasted at least 4 hours before and 4 hours after dosing. Then participants crossed over to Cycle 2. On Day 1 of Cycle 2, participants allowed a low-fat meal. Participants ingest the specified meal within a 30-minute period and receive ixabepilone, 25 mg, 30 minutes after start of the meal. For the duration of Cycle 2, participants fast 1 hour before and 2 hours after ixabepilone dose.
475333|NCT00422097|P7|Participant Flow|Ixabepilone, MTD (25 mg), With Famotidine|Cohort opened for Cycle 2, once ixabepilone MTD (25 mg) determined. In Cycle 1, participants received ixabepilone, 25 mg, alone, orally once per day on Days 1 through 21. Then participants crossed over to receive famotidine wirh ixabepilone in Cycle 2. Prior to dosing on Day 1 of Cycle 2, famotidine, 40 mg, administered in an oral dose 2 hours before ixabepilone 25-mg dose.
475334|NCT00422097|P6|Participant Flow|Ixabepilone, 30 mg/d|Ixabepilone, 30 mg, given daily orally on Days 1 through 5 every 21 days. If 2 or more of the first 3 participants experience a DLT within the first 21-day course, this dose level will be considered above the MTD. If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD (the maximum dose that can be given to 6 participants without producing a DLT in more than 1 [or fewer than 1/3 if more than 6 participants in cohort)]. On all dosing days in Cycle 1, participants to fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475355|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475356|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475335|NCT00422097|P5|Participant Flow|Ixabepilone, 25 mg/d|Ixabepilone, 25 mg/d, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT in the first 21-day course, a new cohort is opened at the next dose level (30 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. If 2 or more of the 6 participants (or 1/3 or more of a cohort with more than 6 participants) experience a DLT, this dose level will be considered above the MTD. The MTD is the maximum dose that can be given to 6 participants without producing a DLT in more than 1 participant (or fewer than 1/3 if the cohort has more than 6 participants). More participants may be enrolled at any level to provide additional safety data. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475336|NCT00422097|P4|Participant Flow|Ixabepilone, 20 mg/d|Ixabepilone, 20 mg, given daily in oral doses on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (25 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475337|NCT00422097|P3|Participant Flow|Ixabepilone, 15 mg/d|Ixabepilone, 15 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (20 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475338|NCT00422097|P2|Participant Flow|Ixabepilone, 10 mg/d|Ixabepilone, 10 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a DLT during the first 21-day course, a new cohort is opened at the next dose level (15 mg/d). If 1 of the first 3 participants experiences a DLT, an additional 3 participants will be enrolled at this dose level for a total of 6 participants. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475339|NCT00422097|P1|Participant Flow|Ixabepilone, 5 mg/d|Ixabepilone, 5 mg, given once daily in an oral dose on Days 1 through 5 every 21 days. If none of the first 3 participants experiences a dose-limiting toxicity (DLT) in the first 21-day course, a new cohort is opened at the next dose level (10 mg/d). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475340|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475341|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475342|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475343|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475344|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475345|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475346|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475347|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants who received MTD (25 mg) ixabepilone without famotidine and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone with famotidine. Fasted/Fed criteria: Cycle 1: Dose 1 administered after a minimum of a 4-hour fast. Cycle 2: Dose 1 administered with a low-fat meal to crossover cohort.
475348|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|Participants received MTD (25 mg) ixabepilone without famotidine (Cycle 1) and then were crossed over to a cycle in which they received MTD (25 mg) ixabepilone (with famotidine (Cycle 2). On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after ixabepilone treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after the dose.
475349|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
475350|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
475351|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
475352|NCT00422097|O1|Outcome|Ixabepilone, 25 mg/d|
475353|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475354|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475357|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475358|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475359|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475360|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475361|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475362|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475363|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475364|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475365|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475366|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475367|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475368|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475369|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475370|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475371|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475372|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475373|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475374|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475375|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475376|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|All participants who received ixabepilone and who had adequate concentration profiles were included.
475377|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475378|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475379|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475380|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475562|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
475563|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475381|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475382|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475383|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475384|NCT00422097|O1|Outcome|All Treated Participants|Participants received daily oral doses of ixabepilone on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475385|NCT00422097|O6|Outcome|Ixabepilone, 30 mg/d|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475386|NCT00422097|O5|Outcome|Ixabepilone, 25 mg/d|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475387|NCT00422097|O4|Outcome|Ixabepilone, 20 mg/d|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475388|NCT00422097|O3|Outcome|Ixabepilone, 15 mg/d|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475389|NCT00422097|O2|Outcome|Ixabepilone, 10 mg/d|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475390|NCT00422097|O1|Outcome|Ixabepilone, 5 mg/d|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days. On all dosing days in Cycle 1, participants must fast at least 4 hours before and 4 hours after treatment. For Cycles 2 and greater, participants must fast 1 hour before and 2 hours after ixabepilone dose.
475391|NCT00422097|E6|Reported Event|Ixabepilone, 30 mg|Participants received daily oral doses of ixabepilone, 30 mg, on Days 1-5 every 21 days
475392|NCT00422097|E5|Reported Event|Ixabepilone, 25 mg|Participants received daily oral doses of ixabepilone, 25 mg, on Days 1-5 every 21 days
475393|NCT00422097|E4|Reported Event|Ixabepilone, 20 mg|Participants received daily oral doses of ixabepilone, 20 mg, on Days 1-5 every 21 days
475394|NCT00422097|E3|Reported Event|Ixabepilone, 15 mg|Participants received daily oral doses of ixabepilone, 15 mg, on Days 1-5 every 21 days
475395|NCT00422097|E2|Reported Event|Ixabepilone, 10 mg|Participants received daily oral doses of ixabepilone, 10 mg, on Days 1-5 every 21 days
475396|NCT00422097|E1|Reported Event|Ixabepilone, 5 mg|Participants received daily oral doses of ixabepilone, 5 mg, on Days 1-5 every 21 days
475397|NCT00422058|B7|Baseline|Total|Total of all reporting groups
475398|NCT00422058|B6|Baseline|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475399|NCT00422058|B5|Baseline|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475400|NCT00422058|B4|Baseline|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475401|NCT00422058|B3|Baseline|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475402|NCT00422058|B2|Baseline|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475403|NCT00422058|B1|Baseline|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475404|NCT00422058|P6|Participant Flow|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475405|NCT00422058|P5|Participant Flow|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475406|NCT00422058|P4|Participant Flow|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475564|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
475407|NCT00422058|P3|Participant Flow|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475408|NCT00422058|P2|Participant Flow|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475409|NCT00422058|P1|Participant Flow|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475410|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475411|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475412|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475413|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475414|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475415|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475416|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475417|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475418|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475419|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475420|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475421|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475422|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475423|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475424|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475425|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475426|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475427|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475428|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475429|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475565|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475430|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475431|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475432|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475433|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475434|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475435|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475436|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475437|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475438|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475439|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475440|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475441|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475442|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475443|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475444|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475445|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475446|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475447|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475448|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475449|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475450|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475451|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475452|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475566|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
475576|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
475453|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475454|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475455|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475456|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475457|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475458|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475459|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475460|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475461|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475462|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475463|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475464|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475465|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475466|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475467|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475468|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475469|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475470|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475471|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475472|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475473|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475474|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475475|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475567|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475476|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475477|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475478|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475479|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475480|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475481|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475482|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475483|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475484|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475485|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475486|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475487|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475488|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475489|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475490|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475491|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475492|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475493|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475494|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475495|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475496|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475497|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475498|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475568|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
482377|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
475499|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475500|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475501|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475502|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475503|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475504|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475505|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475506|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475507|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475508|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475509|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475510|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475511|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475512|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475513|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475514|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475515|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475516|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475517|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475518|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475519|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475520|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475521|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475569|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475522|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475523|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475524|NCT00422058|O6|Outcome|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475525|NCT00422058|O5|Outcome|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475526|NCT00422058|O4|Outcome|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475527|NCT00422058|O3|Outcome|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475528|NCT00422058|O2|Outcome|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475529|NCT00422058|O1|Outcome|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475530|NCT00422058|E6|Reported Event|Orlistat|Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal, weeks 0-20 (open-label) continued to receive Orlistat capsules 3 times daily (3 x 120 mg) in connection with each main meal in open-label extension period (weeks 20-104)
475531|NCT00422058|E5|Reported Event|Liraglutide 3.0 mg|Liraglutide 3.0 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475532|NCT00422058|E4|Reported Event|Lira 2.4 mg/Lira 3.0 mg|Liraglutide 2.4 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475533|NCT00422058|E3|Reported Event|Lira 1.8 mg/Lira 3.0 mg|Liraglutide 1.8 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475534|NCT00422058|E2|Reported Event|Lira 1.2 mg/Lira 3.0 mg|Liraglutide 1.2 mg once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475535|NCT00422058|E1|Reported Event|Lira Placebo/Lira 2.4 mg/Lira 3.0 mg|Liraglutide placebo once daily, weeks 0-20 (double-blinded), extended to 52 weeks (sponsor was unblinded at 20 weeks). Subjects switched to receive liraglutide 2.4 mg once daily and then liraglutide 3.0 mg once daily in open-label extension period (weeks 52-104)
475536|NCT00422032|B3|Baseline|Total|Total of all reporting groups
475537|NCT00422032|B2|Baseline|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
475538|NCT00422032|B1|Baseline|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
475539|NCT00422032|P2|Participant Flow|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
475540|NCT00422032|P1|Participant Flow|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
475541|NCT00422032|O2|Outcome|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
475542|NCT00422032|O1|Outcome|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
475543|NCT00422032|E2|Reported Event|30 mg/m^2 Clofarabine|Higher Dose Clofarabine Group B: 30 mg/m^2 IV over 1 hour daily for 5 days
475544|NCT00422032|E1|Reported Event|15 mg/m^2 Clofarabine|Lower Dose Clofarabine Group A: 15 mg/m^2 intravenous (IV) over 1 hour daily for 5 days
475545|NCT00421993|B5|Baseline|Total|Total of all reporting groups
475546|NCT00421993|B4|Baseline|Gel Vehicle|Topical Gel Vehicle
475547|NCT00421993|B3|Baseline|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475548|NCT00421993|B2|Baseline|Adapalene Gel|Adapalene Topical Gel
475549|NCT00421993|B1|Baseline|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475550|NCT00421993|P4|Participant Flow|Gel Vehicle|Topical Gel Vehicle
475551|NCT00421993|P3|Participant Flow|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475552|NCT00421993|P2|Participant Flow|Adapalene Gel|Adapalene Topical Gel
475553|NCT00421993|P1|Participant Flow|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475554|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
475555|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475556|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
475557|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475558|NCT00421993|O4|Outcome|Gel Vehicle|Topical Gel Vehicle
475559|NCT00421993|O3|Outcome|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475560|NCT00421993|O2|Outcome|Adapalene Gel|Adapalene Topical Gel
475561|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475577|NCT00421993|O1|Outcome|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475578|NCT00421993|E4|Reported Event|Gel Vehicle|Topical Gel Vehicle
475579|NCT00421993|E3|Reported Event|Benzoyl Peroxide Gel|Benzoyl Peroxide Topical Gel
475580|NCT00421993|E2|Reported Event|Adapalene Gel|Adapalene Topical Gel
475581|NCT00421993|E1|Reported Event|Adapalene/Benzoyl Peroxide Gel|Adapalene/Benzoyl Peroxide Topical Gel
475582|NCT00421954|B1|Baseline|Ziprasidone|Ziprasidone: subjects will use ziprasidone
475583|NCT00421954|P1|Participant Flow|Ziprasidone|Ziprasidone: subjects will use ziprasidone
475584|NCT00421954|O1|Outcome|Ziprasidone|Ziprasidone: subjects will use ziprasidone
475585|NCT00421954|E1|Reported Event|Ziprasidone|Ziprasidone: subjects will use ziprasidone
475586|NCT00421928|B4|Baseline|Total|Total of all reporting groups
475587|NCT00421928|B3|Baseline|Placebo|Matching Placebo twice daily (BID)
475588|NCT00421928|B2|Baseline|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475589|NCT00421928|B1|Baseline|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475590|NCT00421928|P3|Participant Flow|Placebo|Matching Placebo twice daily (BID)
475591|NCT00421928|P2|Participant Flow|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475592|NCT00421928|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475593|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475594|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475595|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475596|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475597|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475598|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475599|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475600|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475601|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475602|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475603|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475604|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475605|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475606|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475607|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475608|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475609|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475610|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475611|NCT00421928|O3|Outcome|Placebo|Matching Placebo twice daily (BID)
475612|NCT00421928|O2|Outcome|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475613|NCT00421928|O1|Outcome|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475614|NCT00421928|E3|Reported Event|Placebo|Matching Placebo twice daily (BID)
475615|NCT00421928|E2|Reported Event|Oxycodone|oxycodone controlled release (CR)20-50mg twice daily (BID)
475616|NCT00421928|E1|Reported Event|Tapentadol (CG5503)|Tapentadol(CG5503) extended release (ER) 100-250mg twice daily (BID)
475617|NCT00421889|B10|Baseline|Total|Total of all reporting groups
475618|NCT00421889|B9|Baseline|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475619|NCT00421889|B8|Baseline|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475620|NCT00421889|B7|Baseline|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475621|NCT00421889|B6|Baseline|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475622|NCT00421889|B5|Baseline|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475623|NCT00421889|B4|Baseline|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475624|NCT00421889|B3|Baseline|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475625|NCT00421889|B2|Baseline|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475626|NCT00421889|B1|Baseline|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475627|NCT00421889|P9|Participant Flow|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475628|NCT00421889|P8|Participant Flow|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475629|NCT00421889|P7|Participant Flow|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475630|NCT00421889|P6|Participant Flow|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475631|NCT00421889|P5|Participant Flow|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475632|NCT00421889|P4|Participant Flow|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475633|NCT00421889|P3|Participant Flow|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475634|NCT00421889|P2|Participant Flow|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475635|NCT00421889|P1|Participant Flow|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 (area under the curve) administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475636|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
475637|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
475638|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
475639|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
475640|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
475641|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
475642|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
475643|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
475644|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
475645|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
475646|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
475647|NCT00421889|O5|Outcome|Belinostat 1000 mg/6-hours|Belinostat 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours
475648|NCT00421889|O4|Outcome|Belinostat 1000 mg/3-hours|Belinostat: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours
475649|NCT00421889|O3|Outcome|Belinostat 1000 mg/30 Min|Belinostat 1000 mg/m2 30-minute IV infusion
475650|NCT00421889|O2|Outcome|Belinostat 800 mg/30 Min|PXD101: 800 mg/m2 30-minute IV infusion
475651|NCT00421889|O1|Outcome|Belinostat 600 mg/30 Minutes|PXD101: 600 mg/m2 30-minute IV infusion
475652|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475653|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475654|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475655|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475681|NCT00421733|P2|Participant Flow|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475682|NCT00421733|P1|Participant Flow|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475656|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475657|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475658|NCT00421889|O3|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475659|NCT00421889|O2|Outcome|Part C: 3-6 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3-6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475660|NCT00421889|O1|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475661|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
475662|NCT00421889|O9|Outcome|Part D: Bladder Cancer MTD|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475663|NCT00421889|O8|Outcome|Part C: 6 Hours Infusion Solid Tumors, Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 6-hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475664|NCT00421889|O7|Outcome|Part C: 3 Hours Infusion, Solid Tumors Except Ovarian Cancer|PXD: 1000 mg/m² was administered as a 3 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475665|NCT00421889|O6|Outcome|Part B: Ovarian Cancer MTD|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475666|NCT00421889|O5|Outcome|Part A: Dose Escalation 1000/5/175|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475667|NCT00421889|O4|Outcome|Part A: Dose Escalation 800/5/175|PXD101: 800 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475668|NCT00421889|O3|Outcome|Part A: Dose Escalation 600/5/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475669|NCT00421889|O2|Outcome|Part A: Dose Escalation 600/NA/175|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: None administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475670|NCT00421889|O1|Outcome|Part A: Dose Escalation 600/5/NA|PXD101: 600 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 0 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475671|NCT00421889|O1|Outcome|Part A|Belinostat: Dose escalating up to 1000 mg/m2 days 1-5 in a 21 day cycle; IV Paclitaxel: administered in an intravenous infusion 2-3 hours after PXD101 infusion on day 3 of a 21 day cycle Carboplatin: administered in an intravenous infusion after paclitaxel on day 3 of a 21 day cycle
475672|NCT00421889|E4|Reported Event|Part D: Bladder Cancer MTD (N=15)|PXD101: 1000 mg/m² 30-minute IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Carboplatin: AUC 5 IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m² IV, 2-3 hours following the infusion of PXD101 on Cycle Day 3
475673|NCT00421889|E3|Reported Event|Part C: 3-6 Hours Infusion (N=7)|PXD: 1000 mg/m² was administered as a 3 or 6 hour IV infusion every 24 hours for 5 days on Day 1-5 every 3 weeks Paclitaxel: 175 mg/m² IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 Carboplatin: AUC of 5 IV administered 2-3 hours following the infusion of PXD101 on cycle Day 3 (carboplatin after paclitaxel)
475674|NCT00421889|E2|Reported Event|Part B: Ovarian Cancer MTD (N=35)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475675|NCT00421889|E1|Reported Event|Part A: Dose Escalation (N=23)|PXD101: 1000 mg/m2 30-minute IV infusion every 24 hours for 5 days every 3 weeks (period of 3 weeks is one cycle) Carboplatin: AUC 5 administered 2-3 hours after PXD101 on Cycle Day 3 Paclitaxel: 175 mg/m2 administered 2-3 hours after PXD101 on Cycle Day 3
475676|NCT00421733|B4|Baseline|Total|Total of all reporting groups
475677|NCT00421733|B3|Baseline|Placebo|Two placebo capsules per dose
475678|NCT00421733|B2|Baseline|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475679|NCT00421733|B1|Baseline|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475680|NCT00421733|P3|Participant Flow|Placebo|Two placebo capsules per dose
475684|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475685|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475686|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
475687|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475688|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475689|NCT00421733|O3|Outcome|Placebo|Two placebo capsules per dose
475690|NCT00421733|O2|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475691|NCT00421733|O1|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475692|NCT00421733|O4|Outcome|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475693|NCT00421733|O3|Outcome|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475694|NCT00421733|O2|Outcome|Combined Paricalcitol 1 Mcg and 2 Mcg|Combined participants in the 1 mcg and 2 mcg paricalcitol groups (N=92+92=184).
475695|NCT00421733|O1|Outcome|Placebo|Two placebo capsules per dose (N=88)
475696|NCT00421733|E3|Reported Event|Placebo|Two placebo capsules per dose
475697|NCT00421733|E2|Reported Event|Paricalcitol 2 Mcg|Two paricalcitol 1 mcg capsules per dose
475698|NCT00421733|E1|Reported Event|Paricalcitol 1 Mcg|One paricalcitol 1 mcg capsule and one matching placebo capsule per dose
475699|NCT00421603|B3|Baseline|Total|Total of all reporting groups
475700|NCT00421603|B2|Baseline|Placebo|Placebo daily dose
475701|NCT00421603|B1|Baseline|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
475702|NCT00421603|P2|Participant Flow|Placebo|Placebo daily dose
475703|NCT00421603|P1|Participant Flow|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
475704|NCT00421603|O2|Outcome|Placebo|Placebo daily dose
475705|NCT00421603|O1|Outcome|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
475706|NCT00421603|E2|Reported Event|Placebo|Placebo daily dose
475707|NCT00421603|E1|Reported Event|Adderall-XR and Topiramate|Adderall-XR doses were titrated over two weeks to a maximum dose of 60 mg daily and topiramate doses were titrated over six weeks to a maximum dose of 150 mg twice daily.
475708|NCT00421408|B3|Baseline|Total|Total of all reporting groups
475709|NCT00421408|B2|Baseline|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475710|NCT00421408|B1|Baseline|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475711|NCT00421408|P2|Participant Flow|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475712|NCT00421408|P1|Participant Flow|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475713|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475714|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475715|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475716|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475717|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475718|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475719|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475720|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475721|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475722|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475723|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475724|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475725|NCT00421408|O2|Outcome|Protein Powder 40 g Daily for 18 Months|"Participants will receive a protein supplement daily (40 g whey protein supplement).~Whey protein supplement : 40-g whey protein supplement daily for 18 months"
475726|NCT00421408|O1|Outcome|Placebo Carbohydrate 40 g Daily for 18 Months|"Participants will receive a placebo supplement daily (40 g maltodextrin).~Placebo : Placebo supplement daily for 18 months"
475727|NCT00421408|E2|Reported Event|Protein Powder 40 g Daily|
475728|NCT00421408|E1|Reported Event|Placebo Carbohydrate Powder 40 g Daily|
475729|NCT00421343|B1|Baseline|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
475730|NCT00421343|P1|Participant Flow|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
475731|NCT00421343|O1|Outcome|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
475732|NCT00421343|E1|Reported Event|Osteoporosis Medication|Everyone received 1000 mg calcium per day plus vitamin D and alendronate 70mg per week.
475733|NCT00421174|B3|Baseline|Total|Total of all reporting groups
475734|NCT00421174|B2|Baseline|Placebo|Placebo plus Corticosteroids
475735|NCT00421174|B1|Baseline|Etanercept|Etanercept plus corticosteroids
475736|NCT00421174|P2|Participant Flow|Placebo|Placebo plus Corticosteroids
475737|NCT00421174|P1|Participant Flow|Etanercept|Etanercept plus corticosteroids
475738|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475739|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475740|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475741|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475742|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475743|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475744|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475745|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475746|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475747|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475748|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475749|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475750|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475751|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475752|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475753|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475754|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475755|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475756|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475757|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475758|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475759|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475760|NCT00421174|O2|Outcome|Placebo|Placebo plus Corticosteroids
475761|NCT00421174|O1|Outcome|Etanercept|Etanercept plus corticosteroids
475762|NCT00421174|E2|Reported Event|Placebo|Placebo plus Corticosteroids
475763|NCT00421174|E1|Reported Event|Etanercept|Etanercept plus corticosteroids
475764|NCT00420992|B3|Baseline|Total|Total of all reporting groups
475765|NCT00420992|B2|Baseline|Placebo|
475766|NCT00420992|B1|Baseline|ALO-01|
475767|NCT00420992|P2|Participant Flow|Placebo|
475768|NCT00420992|P1|Participant Flow|ALO-01|
475769|NCT00420992|O2|Outcome|Placebo|
475770|NCT00420992|O1|Outcome|ALO-01|
475771|NCT00420992|E3|Reported Event|Titration ALO-01|Open-label ALO-01
475772|NCT00420992|E2|Reported Event|Placebo|
475773|NCT00420992|E1|Reported Event|ALO-01|
475774|NCT00420927|B8|Baseline|Total|Total of all reporting groups
475775|NCT00420927|B7|Baseline|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475776|NCT00420927|B6|Baseline|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475777|NCT00420927|B5|Baseline|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475778|NCT00420927|B4|Baseline|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475779|NCT00420927|B3|Baseline|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475780|NCT00420927|B2|Baseline|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo(PBO) during Period 1
475781|NCT00420927|B1|Baseline|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
475782|NCT00420927|P7|Participant Flow|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475783|NCT00420927|P6|Participant Flow|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475784|NCT00420927|P5|Participant Flow|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475785|NCT00420927|P4|Participant Flow|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475786|NCT00420927|P3|Participant Flow|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475787|NCT00420927|P2|Participant Flow|PBO+MTX|Methotrexate (MTX) monotherapy plus blinded placebo during Period 1
475788|NCT00420927|P1|Participant Flow|ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
475789|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475790|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475791|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
482378|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
475792|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475793|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475794|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475795|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475796|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475797|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475798|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475799|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475800|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475801|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475802|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475803|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475804|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475805|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475806|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475807|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475808|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475809|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475810|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475811|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475812|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475813|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475814|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475815|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475816|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475817|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475818|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475819|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475820|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475821|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475822|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475823|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475824|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475825|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475826|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475827|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475828|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
476678|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
475829|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475830|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475831|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475832|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475833|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475834|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475835|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475836|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475837|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475838|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475839|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475840|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475841|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475842|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475843|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475844|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475845|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475846|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475847|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475848|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475849|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475850|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475851|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475852|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475853|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475854|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475855|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475856|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475857|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475858|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475859|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475860|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475861|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475862|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475863|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475864|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475865|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
476129|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
475866|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475867|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475868|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475869|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475870|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475871|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475872|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475873|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475874|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475875|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475876|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475877|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475878|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475879|NCT00420927|O5|Outcome|PBO+MTX/OL ADA+MTX (Arm 5)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1, open-label combination therapy with adalimumab (ADA) and MTX during Period 2
475880|NCT00420927|O4|Outcome|PBO+MTX/PBO+MTX (Arm 4)|Methotrexate (MTX) monotherapy plus blinded placebo (PBO) during Period 1 and Period 2
475881|NCT00420927|O3|Outcome|ADA+MTX/OL ADA+MTX (Arm 3)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1, open-label combination therapy with ADA and MTX during Period 2
475882|NCT00420927|O2|Outcome|ADA+MTX/ADA+MTX (Arm 2)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1 and Period 2
475883|NCT00420927|O1|Outcome|ADA+MTX/PBO+MTX (Arm 1)|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA)during Period 1, MTX monotherapy plus blinded placebo (PBO) during Period 2
475884|NCT00420927|E7|Reported Event|Period 1 PBO+MTX|Combination therapy with methotrexate (MTX) and blinded placebo (PBO) during Period 1
475885|NCT00420927|E6|Reported Event|Period 1 ADA+MTX|Combination therapy with methotrexate (MTX) and blinded adalimumab (ADA) during Period 1
475886|NCT00420927|E5|Reported Event|PBO+MTX/OL ADA+MTX (Arm 5)|Blinded MTX monotherapy during Period 1, open-label combination therapy during Period 2
475887|NCT00420927|E4|Reported Event|PBO+MTX/PBO+MTX (Arm 4)|Blinded MTX monotherapy during Period 1 and Period 2
475888|NCT00420927|E3|Reported Event|ADA+MTX/OL ADA+MTX (Arm 3)|Blinded combination therapy during Period 1, open-label combination therapy during Period 2
475889|NCT00420927|E2|Reported Event|ADA+MTX/ADA+MTX (Arm 2)|Blinded combination ADA+MTX therapy during Period 1 and Period 2
475890|NCT00420927|E1|Reported Event|ADA+MTX/PBO+MTX (Arm 1)|Blinded combination ADA+MTX therapy during Period 1 and blinded MTX monotherapy during Period 2
475891|NCT00418834|B3|Baseline|Total|Total of all reporting groups
475892|NCT00418834|B2|Baseline|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475893|NCT00418834|B1|Baseline|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475894|NCT00418834|P2|Participant Flow|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475895|NCT00418834|P1|Participant Flow|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475896|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475897|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475898|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475899|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475900|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475901|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475902|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475903|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475904|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475905|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475906|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475907|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
476414|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
475908|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475909|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475910|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475911|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475912|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475913|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475914|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475915|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475916|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475917|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475918|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475919|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475920|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475921|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475922|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475923|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475924|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475925|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475926|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475927|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475928|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475929|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475930|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475931|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475932|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475933|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475934|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475935|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475936|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475937|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475938|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475939|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475940|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475941|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475942|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475943|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475944|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475945|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475946|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475947|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475948|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475949|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475950|NCT00418834|O2|Outcome|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475951|NCT00418834|O1|Outcome|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475952|NCT00418834|E2|Reported Event|Atorva 20 mg / Atorva 40 mg|Atorva 20 mg orally once daily for 6 weeks, and up-titrated to Atorva 40 mg orally once daily for an additional 6 weeks
475953|NCT00418834|E1|Reported Event|Atorva 10 mg + EZ|[Atorva 10 mg + Ezetimibe 10 mg] orally once daily for 12 weeks
475954|NCT00418717|B1|Baseline|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
475955|NCT00418717|P1|Participant Flow|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
475956|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
475957|NCT00418717|O1|Outcome|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
475958|NCT00418717|E1|Reported Event|Etanercept (ETN)|"Weeks 1-4 (Treatment period A): Etanercept 25 mg bi-weekly (BW)~Weeks 5-12 (Treatment period B): Etanercept 50mg once weekly (QW)"
475959|NCT00418691|B4|Baseline|Total|Total of all reporting groups
475960|NCT00418691|B3|Baseline|Modafinil|18 mg PO once daily for 4 weeks
475961|NCT00418691|B2|Baseline|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
475962|NCT00418691|B1|Baseline|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
475963|NCT00418691|P3|Participant Flow|Modafinil|18 mg PO once daily for 4 weeks
475964|NCT00418691|P2|Participant Flow|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
475965|NCT00418691|P1|Participant Flow|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
475966|NCT00418691|O3|Outcome|Modafinil|18 mg PO once daily for 4 weeks
475967|NCT00418691|O2|Outcome|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
475968|NCT00418691|O1|Outcome|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
475969|NCT00418691|E3|Reported Event|Modafinil|18 mg PO once daily for 4 weeks
475970|NCT00418691|E2|Reported Event|SR Methylphenidate|Sustained Release (SR) Methylphenidate 200 mg PO once daily for 4 weeks
475971|NCT00418691|E1|Reported Event|IR Methylphenidate|Immediate Release (IR) Methylphenidate 10 mg by mouth (PO) twice daily for 4 weeks
475972|NCT00420849|B1|Baseline|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
475973|NCT00420849|P1|Participant Flow|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
475974|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475975|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475976|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475977|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475978|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475979|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475980|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476056|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476415|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
475981|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475982|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475983|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475984|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475985|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475986|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475987|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475988|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475989|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475990|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475991|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475992|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475993|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476034|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
475994|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475995|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475996|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
475997|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
475998|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
475999|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476000|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476001|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476002|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476003|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476004|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476005|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476006|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476035|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
476007|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476008|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476009|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476010|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476011|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476012|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476013|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476014|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476015|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476016|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476017|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476018|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476019|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476036|NCT00420849|E1|Reported Event|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
476020|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476021|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476022|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476023|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476024|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476025|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476026|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476027|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476028|NCT00420849|O3|Outcome|Lenalidomide - Subpopulation From Spain|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was either administered on Days 1 to 4 of each 28-day cycle or on Days 1, 8, 15, and 22 of each 28-day cycle. Subpopulation includes participants from Spain.
476029|NCT00420849|O2|Outcome|Lenalidomide - Subpopulation From UK + Ireland|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from the UK and Ireland.
476030|NCT00420849|O1|Outcome|Lenalidomide - Subpopulation From Austria + Australia|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle. Subpopulation includes participants from Austria and Australia
476031|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
476032|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
476033|NCT00420849|O1|Outcome|Lenalidomide Plus Dexamethasone|Lenalidomide administered orally, 25 mg daily (QD) for the first 21 days of each 28-day cycle. Pulse dexamethasone administered orally, 40 mg daily on Days 1-4, 9-12, and 17-20 for each 28-day cycle during Cycles 1 to 4 (approximately months 1-4). Beginning with Cycle 5 (approximately month 5), a maintenance dose of dexamethasone (40 mg QD) was administered on Days 1 to 4 of each 28-day cycle.
476037|NCT00420784|B5|Baseline|Total|Total of all reporting groups
476416|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476038|NCT00420784|B4|Baseline|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476039|NCT00420784|B3|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476040|NCT00420784|B2|Baseline|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476041|NCT00420784|B1|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476042|NCT00420784|P4|Participant Flow|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476043|NCT00420784|P3|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476044|NCT00420784|P2|Participant Flow|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476045|NCT00420784|P1|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476046|NCT00420784|O1|Outcome|Telaprevir|"All subjects who received single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week reporting group and for 24 weeks in Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week and Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week reporting groups."
476047|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476048|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476049|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476050|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476051|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476052|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476053|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476054|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476055|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476080|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476057|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476058|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476059|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476060|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476061|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476062|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476063|NCT00420784|O4|Outcome|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476064|NCT00420784|O3|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476065|NCT00420784|O2|Outcome|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476066|NCT00420784|O1|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476067|NCT00420784|E4|Reported Event|PBO 24 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476068|NCT00420784|E3|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a 24 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 24 weeks.
476069|NCT00420784|E2|Reported Event|Telaprevir 24 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1125 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 24 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
476070|NCT00420784|E1|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1125 milligram (mg) tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 24 weeks.
476071|NCT00420745|B3|Baseline|Total|Total of all reporting groups
476072|NCT00420745|B2|Baseline|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476073|NCT00420745|B1|Baseline|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476074|NCT00420745|P2|Participant Flow|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476075|NCT00420745|P1|Participant Flow|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476076|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476077|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476078|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476079|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
482379|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
476081|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476082|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476083|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476084|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476085|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476086|NCT00420745|O2|Outcome|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476087|NCT00420745|O1|Outcome|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476088|NCT00420745|E2|Reported Event|Placebo Group|All subjects received 2 oral doses of placebo, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476089|NCT00420745|E1|Reported Event|Rotarix Group|All subjects received 2 oral doses of Rotarix vaccine, 1 dose at Day 0 and 1 dose at Month 1 or 2 depending on the country.
476090|NCT00420628|B3|Baseline|Total|Total of all reporting groups
476091|NCT00420628|B2|Baseline|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476092|NCT00420628|B1|Baseline|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476093|NCT00420628|P2|Participant Flow|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476094|NCT00420628|P1|Participant Flow|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476095|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476096|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476097|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476098|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476099|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476100|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476101|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476102|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476103|NCT00420628|O2|Outcome|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476104|NCT00420628|O1|Outcome|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476105|NCT00420628|E2|Reported Event|Vehicle|Vehicle used in the study drug administered into affected eye(s) for 14 days
476106|NCT00420628|E1|Reported Event|Loteprednol/Tobramycin|0.5% loteprednol etabonate with 0.3% tobramycin opthalmic suspension administered into affected eye(s) for 14 days
476107|NCT00420511|B3|Baseline|Total|Total of all reporting groups
476108|NCT00420511|B2|Baseline|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
476109|NCT00420511|B1|Baseline|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
476110|NCT00420511|P2|Participant Flow|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
476111|NCT00420511|P1|Participant Flow|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
476112|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
476113|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
476114|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
476115|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
476116|NCT00420511|O2|Outcome|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (orally administered)
476117|NCT00420511|O1|Outcome|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (orally administered)
476118|NCT00420511|E2|Reported Event|Placebo|Matching placebo once daily and metformin 1000 mg twice a day (bid) by mouth (po)
476119|NCT00420511|E1|Reported Event|Sitagliptin|Sitagliptin 100 mg once daily and metformin 1000 mg twice a day (bid) by mouth po
476120|NCT00418665|B4|Baseline|Total|Total of all reporting groups
476121|NCT00418665|B3|Baseline|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476122|NCT00418665|B2|Baseline|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476123|NCT00418665|B1|Baseline|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476124|NCT00418665|P3|Participant Flow|Romiplostim (AMG 531) 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476125|NCT00418665|P2|Participant Flow|Romiplostim (AMG 531) 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476126|NCT00418665|P1|Participant Flow|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476127|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476128|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476130|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476131|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476132|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476133|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476134|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476135|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476136|NCT00418665|O3|Outcome|Romiplostim 750 μg|Romiplostim (AMG 531) 750 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476137|NCT00418665|O2|Outcome|Romiplostim 500 μg|Romiplostim (AMG 531) 500 μg weekly by subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476138|NCT00418665|O1|Outcome|Placebo|Placebo weekly via subcutaneous injection plus lenalidomide 10 mg orally once per day for 16 weeks
476139|NCT00418665|E3|Reported Event|Romiplostim 750 µg|
476140|NCT00418665|E2|Reported Event|Romiplostim 500 µg|
476141|NCT00418665|E1|Reported Event|Placebo|
476142|NCT00418574|B3|Baseline|Total|Total of all reporting groups
476143|NCT00418574|B2|Baseline|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476144|NCT00418574|B1|Baseline|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476145|NCT00418574|P2|Participant Flow|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476146|NCT00418574|P1|Participant Flow|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476147|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476148|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476149|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476150|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476151|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476152|NCT00418574|O2|Outcome|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476153|NCT00418574|O1|Outcome|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476154|NCT00418574|E2|Reported Event|Placebo|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476155|NCT00418574|E1|Reported Event|Abagovomab|2 mg/ml SC, every 2 weeks (for the first 4 doses - induction phase) and then every 4 weeks (maintenance phase)
476156|NCT00418561|B4|Baseline|Total|Total of all reporting groups
476157|NCT00418561|B3|Baseline|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476158|NCT00418561|B2|Baseline|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476159|NCT00418561|B1|Baseline|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476160|NCT00418561|P3|Participant Flow|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476161|NCT00418561|P2|Participant Flow|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476162|NCT00418561|P1|Participant Flow|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476163|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476164|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476165|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476166|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476167|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476168|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476169|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476170|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476171|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476172|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476173|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476174|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476175|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476176|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476177|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476178|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476179|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476180|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476181|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476182|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476183|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476184|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476185|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476186|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476187|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476188|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476189|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476190|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476191|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476192|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476193|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476194|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476195|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476196|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476197|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476198|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476199|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476200|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476201|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476202|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476203|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476204|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476205|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476206|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476207|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476208|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476209|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476210|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476211|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476212|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476213|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476214|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476215|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476216|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476217|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476218|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476219|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476220|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476221|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476222|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476223|NCT00418561|O3|Outcome|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476224|NCT00418561|O2|Outcome|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476225|NCT00418561|O1|Outcome|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476226|NCT00418561|E3|Reported Event|Cohort 3|Repeated doses of 200 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 60 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476227|NCT00418561|E2|Reported Event|Cohort 2|Repeated doses of 100 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), once in every 2 weeks for a period of 26 weeks, as an IV infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476228|NCT00418561|E1|Reported Event|Cohort 1|Single dose of 25 U/kg recombinant human Arylsulphatase A (Metazym, rhASA), thereafter, received repeated doses of 50 U/kg recombinant human Arylsulphatase A, once in every 2 weeks for a period of 26 weeks, as an intravenous (IV) infusion over 30 minutes. Dosage adjustment was done monthly to account for changes in body weight.
476229|NCT00418522|B3|Baseline|Total|Total of all reporting groups
476230|NCT00418522|B2|Baseline|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476231|NCT00418522|B1|Baseline|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476232|NCT00418522|P2|Participant Flow|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476233|NCT00418522|P1|Participant Flow|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476234|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476235|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476236|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476237|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476238|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476239|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476240|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476241|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476242|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476243|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476244|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476245|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476246|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476247|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476248|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476249|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476250|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476251|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476252|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476253|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476254|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476255|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476256|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476257|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476258|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476259|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476260|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476261|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476262|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476263|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476264|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476265|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476266|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476267|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476268|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476269|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476270|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476271|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476272|NCT00418522|O2|Outcome|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476273|NCT00418522|O1|Outcome|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476274|NCT00418522|E2|Reported Event|Insulin Glargine|Insulin glargine, label instruction initiation dose (10 units), and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to oral agents.
476275|NCT00418522|E1|Reported Event|Inhaled Human Insulin|Initiation dose of 1 milligram per meal, and individually adjusted doses, per subject's blood glucose, over the 6 month study, in addition to oral agents.
476276|NCT00420420|B3|Baseline|Total|Total of all reporting groups
476277|NCT00420420|B2|Baseline|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476278|NCT00420420|B1|Baseline|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476279|NCT00420420|P2|Participant Flow|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476280|NCT00420420|P1|Participant Flow|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476281|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476282|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476283|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476284|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476285|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476286|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476287|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476288|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476289|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476290|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476291|NCT00420420|O2|Outcome|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476292|NCT00420420|O1|Outcome|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476293|NCT00420420|E2|Reported Event|Placebo|Patients were randomly assigned to 28 days of treatment with matching placebo taken orally daily (qd).
476294|NCT00420420|E1|Reported Event|MK0249 (5 mg)|Patients were randomly assigned to 28 days of treatment with 5 mg MK-0249 taken orally daily (qd).
476295|NCT00420407|B3|Baseline|Total|Total of all reporting groups
476296|NCT00420407|B2|Baseline|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
476297|NCT00420407|B1|Baseline|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
476298|NCT00420407|P2|Participant Flow|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
476299|NCT00420407|P1|Participant Flow|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
476300|NCT00420407|O2|Outcome|Vasopressin|
476301|NCT00420407|O1|Outcome|Normal Saline|
476302|NCT00420407|E2|Reported Event|Vasopressin|"Vasopressin~vasopressin : vasopressin bolus 4 units followed by continuous infusion 2.4units/hr for 5 hours"
476303|NCT00420407|E1|Reported Event|Normal Saline|"bolus of NS followed by continuous infusion of NS, no vasopressin added~normal saline control : no vasopressin added to bolus or 5 hour continuous infusion"
476304|NCT00420342|B4|Baseline|Total|Total of all reporting groups
476305|NCT00420342|B3|Baseline|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476306|NCT00420342|B2|Baseline|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476307|NCT00420342|B1|Baseline|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476308|NCT00420342|P3|Participant Flow|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476309|NCT00420342|P2|Participant Flow|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476310|NCT00420342|P1|Participant Flow|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476311|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476312|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476313|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476314|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476315|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476316|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476317|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476318|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476319|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
482380|NCT00402987|O4|Outcome|Placebo|
476320|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476321|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476322|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476323|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476324|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476325|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476326|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476327|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476328|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476329|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476330|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476331|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476332|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476333|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476334|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476335|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476336|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476337|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476338|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476339|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476340|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476341|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476342|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476343|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476344|NCT00420342|O3|Outcome|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476345|NCT00420342|O2|Outcome|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476346|NCT00420342|O1|Outcome|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476347|NCT00420342|E3|Reported Event|1.5 mg MPA / 0.3 mg CEE (Prempro)|1.5 mg medroxyprogesterone acetate/0.3 mg conjugated equine estrogen for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476348|NCT00420342|E2|Reported Event|2.0mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|2.0 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476349|NCT00420342|E1|Reported Event|0.5mg DRSP / 1.0mg E2 (Angeliq, BAY86-4891)|0.5 mg drospirenone/1.0 mg 17β-estradiol for 8 weeks (8 weeks plus 3 days for sodium sensitivity subjects)
476350|NCT00420303|B3|Baseline|Total|Total of all reporting groups
476351|NCT00420303|B2|Baseline|Placebo|Subcutaneously once weekly
476352|NCT00420303|B1|Baseline|Etanercept|50mg subcutaneously once weekly
476353|NCT00420303|P2|Participant Flow|Placebo|Subcutaneously once weekly
476354|NCT00420303|P1|Participant Flow|Etanercept|50mg subcutaneously once weekly
476355|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
476356|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
476357|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
476358|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
476359|NCT00420303|O2|Outcome|Placebo|Subcutaneously once weekly
476360|NCT00420303|O1|Outcome|Etanercept|50mg subcutaneously once weekly
476361|NCT00420303|E2|Reported Event|Placebo|Subcutaneously once weekly
476362|NCT00420303|E1|Reported Event|Etanercept|50mg subcutaneously once weekly
476363|NCT00420290|B3|Baseline|Total|Total of all reporting groups
476364|NCT00420290|B2|Baseline|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476365|NCT00420290|B1|Baseline|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476366|NCT00420290|P2|Participant Flow|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476367|NCT00420290|P1|Participant Flow|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476368|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476369|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476370|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476371|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476372|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476373|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476374|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476375|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476376|NCT00420290|O2|Outcome|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476377|NCT00420290|O1|Outcome|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476378|NCT00420290|E2|Reported Event|Placebo|100 mg placebo administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476379|NCT00420290|E1|Reported Event|Kineret|100 mg Interleukin-1 receptor antagonist administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks
476380|NCT00420238|B3|Baseline|Total|Total of all reporting groups
476381|NCT00420238|B2|Baseline|Placebo|Subcutaneously (SC), once weekly
476382|NCT00420238|B1|Baseline|Etanercept|50 mg subcutaneously (SC), once weekly
476383|NCT00420238|P2|Participant Flow|Placebo/Etanercept|Placebo subcutaneously (SC), once weekly; Etanercept 50 mg SC, once weekly
476384|NCT00420238|P1|Participant Flow|Etanercept/Etanercept|Etanercept 50 mg subcutaneously (SC) once weekly
476385|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476386|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476387|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476388|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476389|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476390|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476391|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476392|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476393|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476394|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476395|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476396|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476397|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476398|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476399|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476400|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476401|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476402|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476403|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476404|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476405|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476406|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476407|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476408|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476409|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476410|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476411|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476412|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476413|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476417|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476418|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476419|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476420|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476421|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476422|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476423|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476424|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476425|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476426|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476427|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476428|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476429|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476430|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476431|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476432|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476433|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476434|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476435|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476436|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476437|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476438|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476439|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476440|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476441|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476442|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476443|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476444|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476445|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476446|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476447|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476448|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476449|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476450|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476451|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476452|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476453|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476454|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476455|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476456|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476457|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476458|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476459|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476460|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476461|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476462|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476463|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476464|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476465|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476466|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476467|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476468|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476469|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476470|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476471|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476472|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476473|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476474|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476475|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476476|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476477|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476478|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476479|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476480|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476481|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476482|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476483|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476484|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476485|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476486|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476487|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476488|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476489|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: Placebo subcutaneously (SC), once weekly; Open-label Period 2: Etanercept subcutaneously (SC), once weekly
476490|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476491|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476492|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476493|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476494|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476495|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476496|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476497|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476498|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476499|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476500|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476501|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476502|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476503|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476504|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476505|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476506|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476507|NCT00420238|O2|Outcome|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476508|NCT00420238|O1|Outcome|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: etanercept 50 mg subcutaneously (SC), once weekly
476509|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476510|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476511|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476512|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476513|NCT00420238|O2|Outcome|Placebo|Subcutaneously (SC), once weekly
476514|NCT00420238|O1|Outcome|Etanercept|50 mg subcutaneously (SC), once weekly
476515|NCT00420238|E4|Reported Event|Placebo/Etanercept|Double-blind Period 1: placebo subcutaneously (SC), once weekly; Open-label Period 2: etanercept subcutaneously (SC), once weekly
476516|NCT00420238|E3|Reported Event|Etanercept/Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly; Open-label Period 2: Etanercept 50 mg subcutaneously (SC), once weekly
476517|NCT00420238|E2|Reported Event|Placebo|Double-blind Period 1: placebo subcutaneously (SC), once weekly
476518|NCT00420238|E1|Reported Event|Etanercept|Double-blind Period 1: Etanercept 50 mg subcutaneously (SC) once weekly
476519|NCT00420212|B4|Baseline|Total|Total of all reporting groups
476520|NCT00420212|B3|Baseline|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476521|NCT00420212|B2|Baseline|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476522|NCT00420212|B1|Baseline|Placebo|Participants received two placebo capsules orally three times daily (TID)
476523|NCT00420212|P3|Participant Flow|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476524|NCT00420212|P2|Participant Flow|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476525|NCT00420212|P1|Participant Flow|Placebo|Participants received two placebo capsules orally three times daily (TID)
476526|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476527|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476528|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476529|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476530|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476531|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476532|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476533|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476534|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476535|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476536|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476537|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476538|NCT00420212|O3|Outcome|BG00012 240 mg TID|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476539|NCT00420212|O2|Outcome|BG00012 240 mg BID|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476540|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476541|NCT00420212|O3|Outcome|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476542|NCT00420212|O2|Outcome|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476543|NCT00420212|O1|Outcome|Placebo|Participants received two placebo capsules orally three times daily (TID)
476544|NCT00420212|E4|Reported Event|Total BG00012|Combined BG00012 240 mg twice daily (BID) dose group and BG00012 240 mg 3 times daily (TID) dose group
476545|NCT00420212|E3|Reported Event|BG00012 240 mg 3 Times Daily (TID)|Participants received two 120 mg BG00012 capsules orally three times daily (TID)
476546|NCT00420212|E2|Reported Event|BG00012 240 mg Twice Daily (BID)|Participants received two 120 mg BG00012 capsules orally twice daily (BID) and two placebo capsules orally once daily (QD)
476547|NCT00420212|E1|Reported Event|Placebo|Participants received two placebo capsules orally three times daily (TID)
476548|NCT00420199|B3|Baseline|Total|Total of all reporting groups
476549|NCT00420199|B2|Baseline|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
476550|NCT00420199|B1|Baseline|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
476551|NCT00420199|P2|Participant Flow|Placebo (PLA) + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
476552|NCT00420199|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX)|Abatacept was administered intravenously (IV) on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg.
476553|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476554|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476555|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476556|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
476557|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476558|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476559|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476560|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476613|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476561|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476562|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476563|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476564|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476565|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476566|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476567|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476568|NCT00420199|O2|Outcome|Placebo (PLA) + MTX|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476569|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476570|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476571|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476572|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476573|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476574|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476575|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476576|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476577|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476578|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476579|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476580|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476581|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476582|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476583|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476584|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476585|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476586|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476587|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476588|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476589|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476590|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476591|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476592|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476593|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476594|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
476595|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476596|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476597|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered IV and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476598|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate.
476599|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476600|NCT00420199|O2|Outcome|Placebo + Methotrexate|Placebo was administered IV on Days 1, 15, and 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of at least 15 mg (or a maximum tolerated dose, such as 10 mg weekly) of methotrexate).
476601|NCT00420199|O1|Outcome|Abatacept + Methotrexate|Abatacept was administered intravenously on Days 1, 15, and 29 and every 28 days up to and including Day 113. Abatacept dose was based on body weight: 500 mg for participants weighing <60 kg, 750 mg for participants weighing 60 to 100 kg, and 1 gram for participants weighing >100 kg.
476602|NCT00420199|E2|Reported Event|PLA + MTX|PLA was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
476603|NCT00420199|E1|Reported Event|ABA + MTX|Abatacept was administered IV on Day 1, 15, 29 and every 28 days up to and including Day 113.Abatacept was given as a dose based on body weight: 500 mg for participants weighing < 60 kg, 750 mg for participants weighing 60 to 100 kg and 1 gram for participants weighing > 100 kg. In addition, participants received a weekly dose of MTX of at least 15 mg or a maximum tolerated dose (ie, 10 mg weekly)
476604|NCT00420095|B3|Baseline|Total|Total of all reporting groups
476605|NCT00420095|B2|Baseline|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
476606|NCT00420095|B1|Baseline|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
476607|NCT00420095|P2|Participant Flow|Insulin Lispro Low Mix First, Then Human Insulin Mix 30/70|Insulin lispro low mix for 12 weeks followed by human insulin mix 30/70 for 12 weeks
476608|NCT00420095|P1|Participant Flow|Human Insulin Mix 30/70 First, Then Insulin Lispro Low Mix|Human insulin mix 30/70 for 12 weeks followed by insulin lispro low mix for 12 weeks
476609|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476610|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476611|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476612|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476614|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476615|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476616|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476617|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476618|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476619|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476620|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476621|NCT00420095|O2|Outcome|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476622|NCT00420095|O1|Outcome|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476623|NCT00420095|E2|Reported Event|Insulin Lispro Low Mix|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476624|NCT00420095|E1|Reported Event|Human Insulin Mix 30/70|Patient adjusted dose, twice daily (BID), injected subcutaneous (SC) x 12 weeks.
476625|NCT00420056|B1|Baseline|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476626|NCT00420056|P1|Participant Flow|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476627|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476628|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476629|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476630|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476631|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476632|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476633|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476634|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476635|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476636|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476676|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476677|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476637|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476638|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476639|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476640|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476641|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476642|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476643|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476644|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476645|NCT00420056|O1|Outcome|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476646|NCT00420056|E1|Reported Event|PD 0332991|PD 0332991 125 milligram (mg) capsule orally once daily in cycles of continuous dosing for 3 weeks followed by 1-week rest, with no dosing (schedule 3/1) until objective disease progression, withdrawal due to unacceptable toxicity or withdrawal of consent by the participant. Dose was reduced up to PD 0332991 75 mg once daily depending on the type and severity of toxicity encountered and as per investigator’s discretion.
476647|NCT00420017|B3|Baseline|Total|Total of all reporting groups
476648|NCT00420017|B2|Baseline|Control|Control usual care
476649|NCT00420017|B1|Baseline|Amiodarone|Intravenous amiodarone
476650|NCT00420017|P2|Participant Flow|Control|Control usual care
476651|NCT00420017|P1|Participant Flow|Amiodarone|Intravenous amiodarone
476652|NCT00420017|O2|Outcome|Control|Control usual care
476653|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
476654|NCT00420017|O2|Outcome|Control|Control usual care
476655|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
476656|NCT00420017|O2|Outcome|Control|Control usual care
476657|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
476658|NCT00420017|O2|Outcome|Control|Control usual care
476659|NCT00420017|O1|Outcome|Amiodarone|Intravenous amiodarone
476660|NCT00420017|E2|Reported Event|Control|Control usual care
476661|NCT00420017|E1|Reported Event|Amiodarone|Intravenous amiodarone
476662|NCT00419952|B3|Baseline|Total|Total of all reporting groups
476663|NCT00419952|B2|Baseline|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476664|NCT00419952|B1|Baseline|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476665|NCT00419952|P2|Participant Flow|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476666|NCT00419952|P1|Participant Flow|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476667|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476668|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476669|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476670|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476671|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476672|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476673|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476674|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476675|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476679|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476680|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476681|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476682|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476683|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476684|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476685|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476686|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476687|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476688|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476689|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476690|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476691|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476692|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476693|NCT00419952|O2|Outcome|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476694|NCT00419952|O1|Outcome|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476695|NCT00419952|E2|Reported Event|Budesonide|Budesonide HFA pMDI 160 ug x 2 actuations (twice daily) BID
476696|NCT00419952|E1|Reported Event|Symbicort|Symbicort pMDI 160/4.5 ug x 2 actuations (twice daily) BID
476697|NCT00419926|B3|Baseline|Total|Total of all reporting groups
476698|NCT00419926|B2|Baseline|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476699|NCT00419926|B1|Baseline|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476700|NCT00419926|P2|Participant Flow|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476701|NCT00419926|P1|Participant Flow|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476702|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476703|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476704|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476705|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476706|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476707|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476708|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476709|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476710|NCT00419926|O2|Outcome|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476711|NCT00419926|O1|Outcome|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476712|NCT00419926|E2|Reported Event|Standard Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the standard Myfortic dosing regimen, the initial dose of 1440mg/day had to be maintained throughout the whole study.
476713|NCT00419926|E1|Reported Event|Intensified Mycophenolate Sodium (Myfortic) Dosing Regimen|In patients randomized to the intensified Myfortic dosing regimen, the initial dose was 2-fold of the labeled dose (i.e. 2880 mg/day). The dosage was reduced to standard level in two steps,i.e. reduction to 2160 mg/day after 2 weeks of treatment and to 1440 mg/day after 6 weeks of treatment.
476714|NCT00419770|B3|Baseline|Total|Total of all reporting groups
476715|NCT00419770|B2|Baseline|Placebo|Placebo control plus background liposomal amphotericin
476716|NCT00419770|B1|Baseline|Deferasirox|Deferasirox plus liposomal amphotericin
476717|NCT00419770|P2|Participant Flow|Placebo|Placebo control plus background liposomal amphotericin
476718|NCT00419770|P1|Participant Flow|Deferasirox|Deferasirox plus liposomal amphotericin
476719|NCT00419770|O2|Outcome|Placebo|Placebo control plus background liposomal amphotericin
476720|NCT00419770|O1|Outcome|Deferasirox|Deferasirox plus liposomal amphotericin
476721|NCT00419770|E2|Reported Event|Placebo|Placebo control plus background liposomal amphotericin
476722|NCT00419770|E1|Reported Event|Deferasirox|Deferasirox plus liposomal amphotericin
476723|NCT00419757|B3|Baseline|Total|Total of all reporting groups
476724|NCT00419757|B2|Baseline|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476725|NCT00419757|B1|Baseline|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476726|NCT00419757|P2|Participant Flow|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476727|NCT00419757|P1|Participant Flow|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476728|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
476729|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
476730|NCT00419757|O2|Outcome|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
476731|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
476732|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476733|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476734|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476735|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476736|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476737|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476738|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476739|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476740|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476741|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476742|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476743|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476744|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476745|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476746|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476747|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476748|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476749|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476750|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476751|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476752|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476753|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476754|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476755|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476756|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476757|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476758|NCT00419757|O2|Outcome|Budesonide|Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily
476759|NCT00419757|O1|Outcome|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2actuations twice daily
476760|NCT00419757|E2|Reported Event|Budesonide|budesonide HFA pMDI 160 μg x 2 actuations twice daily
476761|NCT00419757|E1|Reported Event|Symbicort|SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily
476762|NCT00419744|B4|Baseline|Total|Total of all reporting groups
476763|NCT00419744|B3|Baseline|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476764|NCT00419744|B2|Baseline|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476765|NCT00419744|B1|Baseline|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476766|NCT00419744|P3|Participant Flow|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476767|NCT00419744|P2|Participant Flow|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476768|NCT00419744|P1|Participant Flow|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476769|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476770|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476771|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476772|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476773|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476774|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476775|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476776|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476777|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476778|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476779|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476780|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476781|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476782|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476783|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476784|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476785|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476786|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476787|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476788|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476789|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476790|NCT00419744|O3|Outcome|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476791|NCT00419744|O2|Outcome|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476792|NCT00419744|O1|Outcome|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476793|NCT00419744|E3|Reported Event|FOR 4.5 X 2 BID|Formoterol Turbuhaler 4.5 μg x 2 inhalations BID
476794|NCT00419744|E2|Reported Event|SYM 80/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 80/4.5 μg (delivered dose) per actuation, 2 actuations administered BID
476795|NCT00419744|E1|Reported Event|SYM 160/4.5 X 2 BID|SYMBICORT pMDI (budesonide/formoterol) 160/4.5 μg (delivered dose) per actuation, 2 actuations administered twice daily (BID)
476796|NCT00418379|B4|Baseline|Total|Total of all reporting groups
476797|NCT00418379|B3|Baseline|Placebo|Placebo tablet
476798|NCT00418379|B2|Baseline|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
476799|NCT00418379|B1|Baseline|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
476800|NCT00418379|P3|Participant Flow|Placebo|Placebo tablet
476801|NCT00418379|P2|Participant Flow|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
476802|NCT00418379|P1|Participant Flow|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
476803|NCT00418379|O3|Outcome|Placebo|Placebo tablet
476804|NCT00418379|O2|Outcome|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
476805|NCT00418379|O1|Outcome|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
476806|NCT00418379|E3|Reported Event|Placebo|Placebo tablet
476807|NCT00418379|E2|Reported Event|300 IR (2M)|300 IR grass pollen allergen extract tablet, treatment starting 2 months before the pollen season
476808|NCT00418379|E1|Reported Event|300 IR (4M)|300 IR grass pollen allergen extract tablet, treatment starting 4 months before the pollen season
476809|NCT00419445|B4|Baseline|Total|Total of all reporting groups
476810|NCT00419445|B3|Baseline|150 mg Tid|
476811|NCT00419445|B2|Baseline|75 mg Tid|
476812|NCT00419445|B1|Baseline|25 mg Tid|
476813|NCT00419445|P3|Participant Flow|150 mg Tid|
476814|NCT00419445|P2|Participant Flow|75 mg Tid|
476815|NCT00419445|P1|Participant Flow|25 mg Tid|
476816|NCT00419445|O3|Outcome|150 mg Tid|
476817|NCT00419445|O2|Outcome|75 mg Tid|
476818|NCT00419445|O1|Outcome|25 mg Tid|
476819|NCT00419445|E3|Reported Event|150 mg Tid|
476820|NCT00419445|E2|Reported Event|75 mg Tid|
476821|NCT00419445|E1|Reported Event|25 mg Tid|
476822|NCT00419393|B1|Baseline|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476823|NCT00419393|P1|Participant Flow|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476824|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476825|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476826|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476827|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476828|NCT00419393|O1|Outcome|Keppra XR|1000 - 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476829|NCT00419393|E1|Reported Event|Keppra XR (Levetiracetam XR)|1000 – 3000 mg/day Keppra XR (Levetiracetam XR), flexible dosing, throughout the duration of the study (planned: approximately 6 months-3 years)
476830|NCT00419380|B3|Baseline|Total|Total of all reporting groups
476831|NCT00419380|B2|Baseline|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476832|NCT00419380|B1|Baseline|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476833|NCT00419380|P2|Participant Flow|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476834|NCT00419380|P1|Participant Flow|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476835|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
476836|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
476837|NCT00419380|O2|Outcome|Ofloxin|Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
476838|NCT00419380|O1|Outcome|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
476839|NCT00419380|E2|Reported Event|Ofloxin|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476840|NCT00419380|E1|Reported Event|Dornase Alfa (Pulmozyme®)|dornase alfa (Pulmozyme®): This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment [dornase alfa (Pulmozyme®)]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
476841|NCT00419341|B1|Baseline|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476842|NCT00419341|P1|Participant Flow|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476843|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476844|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476845|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476846|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476847|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476848|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476849|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476850|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476851|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476852|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476853|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476854|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476855|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476856|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476857|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476858|NCT00419341|O2|Outcome|IVIG (Privigen; Previous Study)|Privigen is a liquid formulation of normal human IgG at a concentration of 10% administered as an intravenous infusion every 3 or 4 weeks.
476859|NCT00419341|O1|Outcome|IgPro20 (PK Substudy)|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476860|NCT00419341|O1|Outcome|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476861|NCT00419341|E1|Reported Event|IgPro20|IgPro20 is a liquid formulation of normal human IgG at a concentration of 20% administered as a SC infusion at weekly intervals.
476862|NCT00419315|B3|Baseline|Total|Total of all reporting groups
476863|NCT00419315|B2|Baseline|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476864|NCT00419315|B1|Baseline|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476865|NCT00419315|P2|Participant Flow|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476866|NCT00419315|P1|Participant Flow|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476867|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476868|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476869|NCT00419315|O2|Outcome|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476870|NCT00419315|O1|Outcome|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476871|NCT00419315|E2|Reported Event|Arm 2|"Usual care~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476872|NCT00419315|E1|Reported Event|Arm 1|"Care management for alcohol dependence~Alcohol Care Management: Care management for alcohol dependence with a focus on pharmacotherapy"
476873|NCT00419263|B4|Baseline|Total|Total of all reporting groups
476874|NCT00419263|B3|Baseline|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476875|NCT00419263|B2|Baseline|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476876|NCT00419263|B1|Baseline|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476877|NCT00419263|P3|Participant Flow|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476878|NCT00419263|P2|Participant Flow|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476879|NCT00419263|P1|Participant Flow|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476880|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476881|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476882|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476883|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476884|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476885|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476886|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476887|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476888|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476889|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476890|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476891|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476892|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476893|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476894|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476895|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476896|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476897|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476898|NCT00419263|O3|Outcome|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476899|NCT00419263|O2|Outcome|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476900|NCT00419263|O1|Outcome|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476901|NCT00419263|E4|Reported Event|Total|Total number of subjects who received at least 1 dose of study drug
476902|NCT00419263|E3|Reported Event|Peramivir 300 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of peramivir 150 mg).
476966|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
476903|NCT00419263|E2|Reported Event|Peramivir 150 mg|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (one injection of peramivir 150 mg and one injection of placebo).
476904|NCT00419263|E1|Reported Event|Placebo|Single dose administered as bilateral 2-mL intramuscular injections in each gluteal muscle (2 injections of placebo).
476905|NCT00419159|B3|Baseline|Total|Total of all reporting groups
476906|NCT00419159|B2|Baseline|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476907|NCT00419159|B1|Baseline|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476908|NCT00419159|P2|Participant Flow|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476909|NCT00419159|P1|Participant Flow|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476910|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476911|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476912|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476913|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476914|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476915|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476916|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476917|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476918|NCT00419159|O2|Outcome|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476919|NCT00419159|O1|Outcome|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476920|NCT00419159|E2|Reported Event|Everolimus (RAD001) 10 mg/Day|Participants self-administered daily oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476921|NCT00419159|E1|Reported Event|Everolimus (RAD001) 70 mg/Week|Participants self-administered weekly oral dose of Everolimus (RAD001). Drug supplied as 5 mg tablets in blister packs.
476922|NCT00419120|B1|Baseline|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
476923|NCT00419120|P1|Participant Flow|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
476924|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
476925|NCT00419120|O1|Outcome|Implanted Patients|Patients implanted with Tengion Neo-Bladder Augment
476926|NCT00419120|E1|Reported Event|Safety Population|All patients undergoing screeing and meeting inclusion/exclusion criteria
476927|NCT00419094|B3|Baseline|Total|Total of all reporting groups
476928|NCT00419094|B2|Baseline|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476929|NCT00419094|B1|Baseline|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476930|NCT00419094|P2|Participant Flow|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476931|NCT00419094|P1|Participant Flow|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476932|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476933|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476934|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476935|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476936|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476937|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476938|NCT00419094|O2|Outcome|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476939|NCT00419094|O1|Outcome|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476940|NCT00419094|E2|Reported Event|Keppra XR 2000 mg/Day|2000 mg/day once daily for 18 weeks (administered as four Keppra XR tablets once daily)
476941|NCT00419094|E1|Reported Event|Keppra XR 1000 mg/Day|1000 mg/day once daily for 18 weeks (administered as two Keppra XR tablets and two placebo tablets once daily)
476942|NCT00419003|B3|Baseline|Total|Total of all reporting groups
476943|NCT00419003|B2|Baseline|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476967|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476968|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
476944|NCT00419003|B1|Baseline|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476945|NCT00419003|P2|Participant Flow|Placebo Pre-Treatment (Phase I)/Placebo (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
476946|NCT00419003|P1|Participant Flow|Lamotrigine Pre-Treatment (Phase I)/Riluzole (Phase II)|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth. All non responders were exited from the study. All responders (in both the lamotrigine and placebo pre-treatment groups were treated as one group and randomized into either treatment with riluzole or placebo for Phase II)
476947|NCT00419003|O2|Outcome|Placebo|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo.
476948|NCT00419003|O1|Outcome|Riluzole Group|Patients who responded (n=14) to the ketamine infusion (in either the lamotrigine or placebo pre-treatment groups) were randomized into phase II for treatment with either riluzole or placebo. One patient in the riluzole group was discontinued/withdrew consent before completing the study.
476949|NCT00419003|E5|Reported Event|Placebo Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476950|NCT00419003|E4|Reported Event|Lamotrigine Pre-Treatment|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476951|NCT00419003|E3|Reported Event|Ketamine|IV infusion of 0.5 mg/kg of Ketamine Hydrochloride
476952|NCT00419003|E2|Reported Event|Placebo|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476953|NCT00419003|E1|Reported Event|Riluzole Group|Patients who met enrolment criteria for phase 1 were randomly allocated to lamotrigine or placebo by a permuted block procedure consisting of blocks of two or four patients. The randomization list was created by a biostatistician with no patient contact. Following baseline ratings, 2 h prior to i.v. ketamine infusion, patients received 300 mg lamotrigine or placebo by mouth.
476954|NCT00418977|B3|Baseline|Total|Total of all reporting groups
476955|NCT00418977|B2|Baseline|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476956|NCT00418977|B1|Baseline|Family Based Therapy|Participants received family based therapy (FBT)
476957|NCT00418977|P2|Participant Flow|Individual Supportive Psychotherapy|"Participants received individual supportive psychotherapy (ISP)~Individual Supportive Psychotherapy: The goal of ISP is for the patient to understand and address the psychological issues underlying the origin and maintenance of the eating disorder. This work is done directly with the child/adolescent. In this treatment, eating disorders are seen as complicated (e.g., they tend to mask other underlying difficulties). In Phase I, the aims are to establish a sound therapeutic relationship, obtain a comprehensive description of the eating problem and its development, identify underlying problems that might be responsible for the disordered eating, and inform the patient about the dangers of eating disorders. Phase II encourages participants to explore underlying emotional problems, facilitates self-disclosure and expression of feelings, and fosters independence. Phase III focuses on how other underlying issues might affect future adjustment."
476958|NCT00418977|P1|Participant Flow|Family Based Therapy|"Participants received family based therapy (FBT)~Family-Based Therapy (Maudsley Method): The goal of FBT is to resolve the eating disorder and return the patient to healthy psychosocial and physiological development through active family involvement across three treatment phases. In Phase I, therapy is focused on the disordered eating. The therapist primarily makes careful, persistent requests for united parental action toward re-feeding and/or regulating eating habits and directs the discussion so as to create and reinforce a strong parental alliance around their efforts at feeding their child. In Phase II, the goal is to gradually transfer control over eating back to the participant, with the parents still maintaining general oversight and responsibility for continued progression toward healthy habits. In Phase III, the central goal is establishment of a healthy child or adolescent relationship with the parents where disordered eating is not the basis of interaction."
476959|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476960|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
476961|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476962|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
476963|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476964|NCT00418977|O1|Outcome|Family Based Therapy|Participants received family based therapy (FBT)
476965|NCT00418977|O2|Outcome|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476969|NCT00418977|E2|Reported Event|Individual Supportive Psychotherapy|Participants received individual supportive psychotherapy (ISP)
476970|NCT00418977|E1|Reported Event|Family Based Therapy|Participants received family based therapy (FBT)
476971|NCT00418964|B4|Baseline|Total|Total of all reporting groups
476972|NCT00418964|B3|Baseline|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
476973|NCT00418964|B2|Baseline|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
476974|NCT00418964|B1|Baseline|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
476975|NCT00418964|P3|Participant Flow|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
476976|NCT00418964|P2|Participant Flow|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
476977|NCT00418964|P1|Participant Flow|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
476978|NCT00418964|O3|Outcome|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
476979|NCT00418964|O2|Outcome|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
476980|NCT00418964|O1|Outcome|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
476981|NCT00418964|E3|Reported Event|BPTB|Bone Patellar Tendon Bone (Bone patellar tendon bone autograft in a single bone tunnel)
476982|NCT00418964|E2|Reported Event|HT-DB|Double bundle hamstring (hamstring autograft in two bone tunnels)
476983|NCT00418964|E1|Reported Event|HT-SB|Single bundle hamstring (hamstring autograft in a single bone tunnel)
476984|NCT00418951|B4|Baseline|Total|Total of all reporting groups
476985|NCT00418951|B3|Baseline|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
476986|NCT00418951|B2|Baseline|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
476987|NCT00418951|B1|Baseline|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
476988|NCT00418951|P3|Participant Flow|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
476989|NCT00418951|P2|Participant Flow|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
476990|NCT00418951|P1|Participant Flow|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
476991|NCT00418951|O3|Outcome|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
476992|NCT00418951|O2|Outcome|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
476993|NCT00418951|O1|Outcome|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
476994|NCT00418951|E3|Reported Event|Voriconazole: 400 mg|400 mg oral twice daily day 1 followed by 200 mg twice daily
476995|NCT00418951|E2|Reported Event|Liposomal Amphotericin B: 9 mg/kg|9 mg/kg IV once per week
476996|NCT00418951|E1|Reported Event|Liposomal Amphotericin B: 3 mg/kg|3 mg/kg intravenously (IV) three times per week
476997|NCT00418938|B3|Baseline|Total|Total of all reporting groups
476998|NCT00418938|B2|Baseline|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
476999|NCT00418938|B1|Baseline|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477000|NCT00418938|P2|Participant Flow|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477001|NCT00418938|P1|Participant Flow|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477002|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477003|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477004|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477005|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477006|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477007|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477008|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477009|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477010|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477011|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477012|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477013|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477014|NCT00418938|O2|Outcome|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477015|NCT00418938|O1|Outcome|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477067|NCT00418184|E2|Reported Event|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
477016|NCT00418938|E2|Reported Event|Bevacizumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus bevacizumab (either 5 mg/kg or 10 mg/kg, depending on physician choice and institutional standard of care)
477017|NCT00418938|E1|Reported Event|Panitumumab Plus FOLFIRI|subjects in this arm receive once-every-2-weeks (Q2W) FOLFIRI regimen plus panitumumab 6 mg/kg
477018|NCT00418886|B3|Baseline|Total|Total of all reporting groups
477019|NCT00418886|B2|Baseline|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477020|NCT00418886|B1|Baseline|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477021|NCT00418886|P2|Participant Flow|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477022|NCT00418886|P1|Participant Flow|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477023|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477024|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477025|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477026|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477027|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477028|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477029|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477030|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477031|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477032|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477033|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477034|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477035|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477036|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477037|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477038|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477039|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477040|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477041|NCT00418886|O2|Outcome|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477042|NCT00418886|O1|Outcome|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477043|NCT00418886|E2|Reported Event|Placebo Plus Pemetrexed|Placebo plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477044|NCT00418886|E1|Reported Event|Vandetanib Plus Pemetrexed|vandetanib (100 mg daily) plus pemetrexed (500 mg/m2 given on Day 1 of each 21-day cycle)
477045|NCT00418314|B3|Baseline|Total|Total of all reporting groups
477046|NCT00418314|B2|Baseline|Control|Empiric programming or one-time optimization using a non-IEGM method.
477047|NCT00418314|B1|Baseline|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477048|NCT00418314|P2|Participant Flow|Control|Empiric programming or one-time optimization using a non-IEGM method.
477049|NCT00418314|P1|Participant Flow|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477050|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
477051|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477052|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
477053|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477054|NCT00418314|O2|Outcome|Control|Empiric programming or one-time optimization using a non-IEGM method.
477055|NCT00418314|O1|Outcome|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477056|NCT00418314|E2|Reported Event|Control|Empiric programming or one-time optimization using a non-IEGM method.
477057|NCT00418314|E1|Reported Event|QuickOpt (Treatment)|Frequent optimization using QuickOpt to optimize the AV/PV and VV Delays.
477058|NCT00418184|B3|Baseline|Total|Total of all reporting groups
477059|NCT00418184|B2|Baseline|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
477060|NCT00418184|B1|Baseline|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
477061|NCT00418184|P2|Participant Flow|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
477062|NCT00418184|P1|Participant Flow|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
477063|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
477064|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
477065|NCT00418184|O2|Outcome|Placebo|Double-blind: Cellulose (4 capsules per day). Open-label: PS-omega3
477066|NCT00418184|O1|Outcome|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
477068|NCT00418184|E1|Reported Event|PS Omega 3 Conjugate|The daily dosage consisted of 4 capsules of PS-Omega3, providing 300 mg Phosphatidylserine per day.
477069|NCT00418093|B1|Baseline|Group 1|
477070|NCT00418093|P1|Participant Flow|Chemotherapy Group|Oxaliplatin plus Gemcitabine plus Bevacizumab
477071|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
477072|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
477073|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
477074|NCT00418093|O1|Outcome|Chemotherapy Group|Oxaliplatin, Gemcitabine, Bevacizumab
477075|NCT00418093|E1|Reported Event|Group 1|
477076|NCT00418015|B5|Baseline|Total|Total of all reporting groups
477077|NCT00418015|B4|Baseline|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477078|NCT00418015|B3|Baseline|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477079|NCT00418015|B2|Baseline|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477080|NCT00418015|B1|Baseline|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477081|NCT00418015|P4|Participant Flow|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477082|NCT00418015|P3|Participant Flow|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477083|NCT00418015|P2|Participant Flow|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477084|NCT00418015|P1|Participant Flow|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477085|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477086|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477087|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477088|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477089|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477090|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477091|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477092|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477093|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477094|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477095|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477096|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477097|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477098|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477099|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477100|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477101|NCT00418015|O4|Outcome|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477102|NCT00418015|O3|Outcome|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477103|NCT00418015|O2|Outcome|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477104|NCT00418015|O1|Outcome|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477105|NCT00418015|E4|Reported Event|Cesarean Delivery OPRM1 c304A>G|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were heterozygous for OPRM1 c304A>G
477383|NCT00416572|B4|Baseline|Total|Total of all reporting groups
477106|NCT00418015|E3|Reported Event|Cesarean Delivery OPRM1 c304A|Cesarean delivery subjects receiving morphine 150 micrograms with spinal bupivacaine 12mg and fentanyl 15 micrograms that were homozygous for OPRM1 c304A
477107|NCT00418015|E2|Reported Event|Labor Analgesia OPRM1 c304A>G|Parturients receiving spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia that were heterozygous or homozygous for OPRM1 c304A>G
477108|NCT00418015|E1|Reported Event|Labor Analgesia OPRM1 c304A|Parturients that received spinal fentanyl 15 micrograms and epidural fentanyl labor analgesia who were homozygous for OPRM1 c304
477109|NCT00417989|B3|Baseline|Total|Total of all reporting groups
477110|NCT00417989|B2|Baseline|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477111|NCT00417989|B1|Baseline|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477112|NCT00417989|P2|Participant Flow|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477113|NCT00417989|P1|Participant Flow|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477114|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477115|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477116|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477117|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477118|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477119|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477120|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477121|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477122|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477123|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477124|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477125|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477126|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477127|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477128|NCT00417989|O2|Outcome|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477129|NCT00417989|O1|Outcome|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477130|NCT00417989|E2|Reported Event|Multiple Daily Injection (MDI)|MDI arm: Continue with MDI using Lantus and NovoLog/NovoRapid for 1 year
477131|NCT00417989|E1|Reported Event|722 Sensor Augmented Pump|722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
477132|NCT00417976|B1|Baseline|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
477133|NCT00417976|P1|Participant Flow|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
477134|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
477135|NCT00417976|O1|Outcome|Bevacizumab|"Gemcitabine : 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab : 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil : 2400 mg/m2 over 48 hours every 2 weeks."
477136|NCT00417976|E1|Reported Event|Bevacizumab|"Gemcitabine: 1000 mg/m2 over 100 minutes every 2 weeks.~Bevacizumab: 10 mg/kg every 2 weeks.~Infusional 5-Fluorouracil: 2400 mg/m2 over 48 hours every 2 weeks."
477137|NCT00417963|B1|Baseline|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
477138|NCT00417963|P1|Participant Flow|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
477139|NCT00417963|O2|Outcome|6 Month Restenosis|Number of participants with restenosis at 6 months from implantation.
477140|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
477141|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
477142|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|placement of a bare metal stent for treatment of carotid artery stenosis
477143|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
477144|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
477145|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
477146|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
477147|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
477148|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
477149|NCT00417963|O3|Outcome|Pivotal Cohort|Participants who were enrolled in the Pivotal cohort. All Pivotal subjects were included in the intention to treat analysis.
477150|NCT00417963|O2|Outcome|Roll-in Cohort|Participants enrolled in the roll-in cohort of the study. Roll-in patients were not included in the intention to treat analysis.
477151|NCT00417963|O1|Outcome|Stent Placement in the Carotid Artery|All subjects who received the ViVexx Carotid Stent.
477152|NCT00417963|O1|Outcome|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
477153|NCT00417963|E1|Reported Event|ViVexx Carotid Stent Group|placement of a bare metal stent for treatment of carotid artery stenosis
477154|NCT00417885|B1|Baseline|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477155|NCT00417885|P1|Participant Flow|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477156|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477157|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477158|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477159|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477160|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477161|NCT00417885|O1|Outcome|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477162|NCT00417885|E1|Reported Event|Sunitinib + Exemestane|Sunitinib administered orally, in a continuous regimen, dose of 37.5 mg daily. Exemestane coadministered orally at a dose of 25 mg daily.
477163|NCT00417612|B3|Baseline|Total|Total of all reporting groups
477164|NCT00417612|B2|Baseline|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477165|NCT00417612|B1|Baseline|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477166|NCT00417612|P2|Participant Flow|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477167|NCT00417612|P1|Participant Flow|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce Parathyroid Hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477168|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477169|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477170|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477171|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce parathyroid hormone (PTH) level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477172|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477173|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477174|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477175|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477176|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477177|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477178|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477179|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477180|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477181|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477182|NCT00417612|O3|Outcome|Paricalcitol (Children Ages 9-17)|Pediatric patients ages 9-17 given paricalcitol
477183|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477184|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477185|NCT00417612|O2|Outcome|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477186|NCT00417612|O1|Outcome|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477187|NCT00417612|E2|Reported Event|Placebo|"Participants given placebo capsule to match for comparison~Placebo: Placebo sugar pill"
477188|NCT00417612|E1|Reported Event|Paricalcitol (Active Drug)|"Participants given active drug, paricalcitol (Zemplar), in effort to reduce PTH level~Paricalcitol: Paricalcitol given first as a dose of 2 capsules once per day. Dose titration as needed per biochemical results at outpatient visits."
477189|NCT00417482|B4|Baseline|Total|Total of all reporting groups
477190|NCT00417482|B3|Baseline|Phase B Arm 3: Placebo-Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
477191|NCT00417482|B2|Baseline|Phase B Arm 2: Risperidone -Placebo|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
477192|NCT00417482|B1|Baseline|Phase B Arm 1: Risperidone-Risperidone|Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3). For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.
477193|NCT00417482|P3|Participant Flow|Phase B Arm 3: Placebo-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 3: Patients were randomized to placebo for 32 weeks."
477194|NCT00417482|P2|Participant Flow|Phase B Arm 2: Risperidone-Placebo|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 2: Risperidone for 16 weeks followed by placebo for 16 weeks;"
477195|NCT00417482|P1|Participant Flow|Arm 1: Risperidone-Risperidone|"Phase A involved open flexible dose risperidone treatment for 16 weeks. At 16 weeks, non-responders exited the study. Responders were randomized, double-blind, to one of three arms in Phase B: (1) continuation risperidone for 32 weeks (Arm 1), (2) risperidone for 16 weeks followed by placebo for 16 weeks (Arm 2), (3) placebo for 32 weeks (Arm 3).~Phase B Arm 1: Risperidone for 16 weeks followed by risperidone for 16 weeks; Risperidone open label flexible dose was administered at a dose of 0.25 to 3 mg daily for first 16 weeks; dose at 16 weeks then fixed for the randomized trial"
477196|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477197|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477198|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477199|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477200|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477201|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477202|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477203|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477204|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477205|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477206|NCT00417482|O2|Outcome|Risperidone|Subjects in Arm 1 and Arm 2, as described above. Subjects in these two arms received risperidone for the first 16 weeks of Phase B, and were combined for purposes of this secondary analysis.
477207|NCT00417482|O1|Outcome|Placebo|Subjects assigned to Arm 3, as described above
477208|NCT00417482|O2|Outcome|Arm 2: Risperidone - Placebo|Subjects in Arm 2 who did not relapse or terminate from the study in the first 16 weeks of Phase B received placebo in the second 16 weeks of Phase B.
477209|NCT00417482|O1|Outcome|Arm 1: Risperidone - Risperidone|Subjects in Arm 1 who did not relapse or terminate from the study in the first 16 weeks of Phase B continued to receive risperidone in the second 16 weeks of Phase B.
477210|NCT00417482|O3|Outcome|Phase B Arm 3: Placebo-Placebo|"40 patients randomized to Phase B Arm 3 received placebo for 32 weeks. For patients receiving risperidone ≥ 2 mg daily at end-Phase A, assignment to placebo in Phase B required an initial one-week taper with sequential double-blind placebo substitution (e.g., one 2 mg tablet switched to one 1 mg tablet and then to one placebo tablet) to reduce antipsychotic physical withdrawal effects.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
477211|NCT00417482|O2|Outcome|Phase B Arm 2: Risperidone -Placebo|"38 patients randomized to Phase B Arm 2 received risperidone therapy for 16 weeks followed by placebo for 16 weeks.~In Phase B, relapse required ≥ 30% increase or 5-point increase in NPI core scores from end-Phase A and a score of 6 (much worse) or 7 (very much worse) on the CGI-C."
477212|NCT00417482|O1|Outcome|Phase B Arm 1: Risperidone-Risperidone|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks.
477213|NCT00417482|E5|Reported Event|Wek 17-32 Phase B Arm 3: Placebo -Placebo|13 patients completed Week 0-16 of Phase B Arm 3 and entered Week 17-32 were they were given placebo for another 16 weeks.
477214|NCT00417482|E4|Reported Event|Wk 17-32 Phase B Arm 2: Risperdone-Placebo|27 patients completed Wk 0-16 of Phase B Arm 2 and entered Week 17-32 of Phase B Arm 2 where they receive placebo for 16 weeks.
477215|NCT00417482|E3|Reported Event|Wk 17-32 Phase B Arm 1: Risperdone-Risperdone|13 patients completed Wk 0-16 of Phase 2 Arm 1 and entered Wk 17-32 where they received risperidone for another 16 weeks.
477216|NCT00417482|E2|Reported Event|Wk 0-16 Phase B Arm 3: Placebo -Placebo|40 patients randomized to Phase B Arm 3 received placebo for 32 weeks.
477217|NCT00417482|E1|Reported Event|Wk0-16 Phase B Arm 1 (Risp-Risp) & Arm 2 (Risp-Pla)|32 patients randomized to Phase B Arm 1 received continuation risperidone for another 32 weeks; 38 patients randomized to Phase B Arm 2 received risperidone for 16 weeks followed by placebo for 16 weeks. Therefore there were a total of 70 patients in this group.
477218|NCT00417417|B3|Baseline|Total|Total of all reporting groups
477219|NCT00417417|B2|Baseline|Placebo|placebo injected every two weeks for two months
477220|NCT00417417|B1|Baseline|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
477221|NCT00417417|P2|Participant Flow|Placebo|placebo injected every two weeks x 4 administrations
477222|NCT00417417|P1|Participant Flow|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
477223|NCT00417417|O2|Outcome|Placebo|Placebo subcutaneous injection x 4 over 8 weeks
477224|NCT00417417|O1|Outcome|Rilonacept|Rilonacept 320 mg subcutaneously x4 over 8 weeks
477225|NCT00417417|O2|Outcome|Placebo|Placebo x 4 injections over 8 weeks
477226|NCT00417417|O1|Outcome|Rilonacept|rilonacept 320 mg x 4 administrations over 8 weeks.
477227|NCT00417417|E2|Reported Event|Placebo|placebo injected every two weeks for two months
477228|NCT00417417|E1|Reported Event|Rilonacept|rilonacept 320 mg injected every 2 weeks x4 administrations.
477229|NCT00417274|B1|Baseline|Quinacrine Treatment|Uncontrolled treatment arm
477230|NCT00417274|P1|Participant Flow|Quinacrine Treatment|100 mg once a day
477231|NCT00417274|O1|Outcome|Quinacrine Treatment|100 mg once a day
477232|NCT00417274|E1|Reported Event|Quinacrine Treatment|Uncontrolled treatment arm
477233|NCT00417248|B1|Baseline|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
477234|NCT00417248|P1|Participant Flow|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
477235|NCT00417248|O1|Outcome|Investigational Treatment|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
477236|NCT00417248|O1|Outcome|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
477237|NCT00417248|E1|Reported Event|Cisplatin/Etoposide/Radiotherapy Followed by Sorafenib|"Cisplatin/Etoposide/Radiotherapy followed by Sorafenib in patients with inoperable stage III non-small cell lung cancer~Cisplatin: Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle~Etoposide: Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle~Radiotherapy: Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)~Sorafenib: Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months"
477238|NCT00417170|B3|Baseline|Total|Total of all reporting groups
477239|NCT00417170|B2|Baseline|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477240|NCT00417170|B1|Baseline|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477241|NCT00417170|P2|Participant Flow|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477242|NCT00417170|P1|Participant Flow|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477243|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477244|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477245|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477246|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477247|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477248|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477249|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477250|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477251|NCT00417170|O2|Outcome|Amlodipine 5 mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477252|NCT00417170|O1|Outcome|Aliskiren 300 mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477253|NCT00417170|E2|Reported Event|Amlodipine 5mg|Amlodipine 5 mg + Placebo Aliskiren orally once daily for 12 weeks.
477254|NCT00417170|E1|Reported Event|Aliskiren 300mg|Aliskiren 300 mg + Placebo Amlodipine orally once daily for 12 weeks.
477255|NCT00417079|B3|Baseline|Total|Total of all reporting groups
477256|NCT00417079|B2|Baseline|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477257|NCT00417079|B1|Baseline|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477258|NCT00417079|P2|Participant Flow|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477259|NCT00417079|P1|Participant Flow|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477260|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477261|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477262|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477263|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477264|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477265|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477266|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477267|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477268|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477269|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477270|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477271|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477272|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477273|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477274|NCT00417079|O2|Outcome|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477275|NCT00417079|O1|Outcome|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477276|NCT00417079|E2|Reported Event|Cabazitaxel + Prednisone|cabazitaxel 25 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477277|NCT00417079|E1|Reported Event|Mitoxantrone + Prednisone|mitoxantrone 12 mg/m^2 (Day 1) by intravenous (IV) every 3 weeks, and prednisone 10 mg orally given daily
477278|NCT00417027|B4|Baseline|Total|Total of all reporting groups
477279|NCT00417027|B3|Baseline|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477280|NCT00417027|B2|Baseline|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477281|NCT00417027|B1|Baseline|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477282|NCT00417027|P3|Participant Flow|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477283|NCT00417027|P2|Participant Flow|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477284|NCT00417027|P1|Participant Flow|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
482381|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
477285|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477286|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477287|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477288|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477289|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477290|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477291|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477292|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477293|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477294|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477295|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477296|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477297|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477298|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477299|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477300|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477301|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477302|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477303|NCT00417027|O3|Outcome|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477304|NCT00417027|O2|Outcome|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477305|NCT00417027|O1|Outcome|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477306|NCT00417027|E3|Reported Event|10ml Bolused Every 60 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 10 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 60 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
482382|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
477307|NCT00417027|E2|Reported Event|5ml Bolused Every 30 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 30 minutes. Patients could request additional 5 ml of the solution via a patient controlled activation to a maximum of 30 ml per hour.
477308|NCT00417027|E1|Reported Event|2.5 mL Bolused Every 15 Minutes|Laboring women receiving a programmed intermittent epidural bolus of 2.5 ml of bupivacaine 6.25 mg/ml and fentanyl 1.96 mcg/ml every 15 minutes. Patients could request additional 5 ml of the solution via a patient controlled administration every 15 minutes to a maximum of 30ml per hour.
477309|NCT00416884|B1|Baseline|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
477310|NCT00416884|P1|Participant Flow|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
477311|NCT00416884|O1|Outcome|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
477312|NCT00416884|E1|Reported Event|TBI, Campath, Fludarabine T-cell Deplete|(Campath) 30 mg on day -8 over 5-6 hours, Fludarabine 30 mg/m2 on day -4 through day -2, Total body irradiation single fraction 200 cGy at 7 cGy per minute on day 0., Stem cells will be T-cell depleted and given on day 0
477313|NCT00416793|B1|Baseline|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
477314|NCT00416793|P1|Participant Flow|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
477315|NCT00416793|O1|Outcome|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
477316|NCT00416793|E1|Reported Event|Bortezomib + Carboplatin|Bortezomib 1.3 mg/m2 by vein (IV) on days 1, 4, 8 + 11; Carboplatin Area Under the Curve (AUC) of 5 IV over 30 minutes
477317|NCT00416624|B5|Baseline|Total|Total of all reporting groups
477318|NCT00416624|B4|Baseline|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477319|NCT00416624|B3|Baseline|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477320|NCT00416624|B2|Baseline|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477321|NCT00416624|B1|Baseline|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477322|NCT00416624|P4|Participant Flow|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477323|NCT00416624|P3|Participant Flow|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477324|NCT00416624|P2|Participant Flow|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477325|NCT00416624|P1|Participant Flow|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477326|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477327|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477328|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477329|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477330|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477331|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477332|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477333|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477334|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477335|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477336|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477337|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477338|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477339|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477340|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477341|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477342|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477343|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477344|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477345|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477346|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477347|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477348|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477349|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477350|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477351|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477352|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477353|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477354|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477355|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477356|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477357|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477358|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477359|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477360|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477361|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477362|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477363|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477364|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477365|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477366|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477367|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477368|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477369|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477370|NCT00416624|O4|Outcome|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477371|NCT00416624|O3|Outcome|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477372|NCT00416624|O2|Outcome|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477373|NCT00416624|O1|Outcome|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477374|NCT00416624|E4|Reported Event|Darbepoetin Alfa - 500 mcg Every 3 Weeks|Patients receive Darbepoetin alfa 500 micrograms (mcg) subcutaneously every 3 weeks for 15 weeks (5 doses)
477375|NCT00416624|E3|Reported Event|Epoetin Alfa - 120k Every 3 Weeks|Patients receive Epoetin alfa 120,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477376|NCT00416624|E2|Reported Event|Epoetin Alfa - 80k Every 3 Weeks|Patients receive Epoetin alfa 80,000 units subcutaneously every 3 weeks for 15 weeks (5 doses)
477377|NCT00416624|E1|Reported Event|Epoetin Alfa - 40k Weekly|Patients receive Epoetin alfa 40,000 units subcutaneously every week for 15 weeks (15 doses)
477378|NCT00416598|B1|Baseline|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
477379|NCT00416598|P1|Participant Flow|Treatment (Chemotherapy, PBSC or Bone Marrow Transplantation)|"See Detailed Description:~Patients undergo induction therapy comprising cytarabine and daunorubicin hydrochloride. Patient with RD undergo second induction therapy comprising cytarabine, daunorubicin hydrochloride, and etoposide. Patients with CR and favorable cytogenetics who achieve CR receive intensification therapy comprising high-dose cytarabine. Patients with UC receive etoposide, high-dose cytarabine, G-CSF., and busulfan and proceed to PBSC or bone marrow transplantation. Patients with UC and unable to undergo transplantation receive etoposide, high-dose cytarabine, and G-CSF. Patients then receive decitabine as maintenance therapy."
477380|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
477381|NCT00416598|O1|Outcome|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
477382|NCT00416598|E1|Reported Event|Decatibine Maintenance|Within 60-90 days after completion of intensification therapy, patients receive 20 mg/m^2 decitabine IV over 1 hour on days 1-5. Treatment repeats every 6 weeks for up to 8 courses.
477384|NCT00416572|B3|Baseline|Control Condition|Participants received care as usual.
477385|NCT00416572|B2|Baseline|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
477386|NCT00416572|B1|Baseline|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
477387|NCT00416572|P3|Participant Flow|Control Condition|Participants received care as usual.
477388|NCT00416572|P2|Participant Flow|Nutrition Education Intervention|"Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.~The nutrition sessions were presented by a professional trained in nutritional science. Sessions included the presentation of information and guided discussion of related topics. The first session discussed information on choosing fruits, vegetables, and low-fat foods and incorporating them into a diet; the second session involved a demonstration of low-fat cooking methods; the third session provided information on the nutritional make-up of a healthy diet and how to shop for it; the last session included information on how to maintain a healthy, low-fat diet while eating out. Women were also asked to keep a four-day food diary, to focus them on their dietary intake and control over it."
477389|NCT00416572|P1|Participant Flow|Education Intervention|"Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.~Sessions were led by two professionals with expertise in the topic. The sessions began a with presentation of informational material followed by guided discussion of related topics. The first session discussed what to say and not say to children about cancer; the second session discussed carrying on with life after the diagnosis of breast cancer, including strategies for managing stress and anxiety and developing meaning in life; the third session talked about how to maintain closeness with a partner and ways to talk about breast cancer; the last session focused on the effects of treatment on reproductive status, and the genetic bases of breast cancer. Participants were also given related booklets and brochures to take home to read."
477390|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
477391|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
477392|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
477393|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
477394|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
477395|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
477396|NCT00416572|O3|Outcome|Control Condition|Participants received care as usual
477397|NCT00416572|O2|Outcome|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
477398|NCT00416572|O1|Outcome|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
477399|NCT00416572|E3|Reported Event|Control Condition|Participants received care as usual.
477400|NCT00416572|E2|Reported Event|Nutrition Education Intervention|Participants attended 2-hr nutrition education sessions, once a month for 4 months. Each session provided information/ encouragement on setting and attaining goals for healthy eating and on the benefits of thinking positively about dealing adaptively with problems and living a healthy lifestyle.
477401|NCT00416572|E1|Reported Event|Education Intervention|Participants attended 2-hr education sessions once a month, for 4 months. The overall goal of the sessions was to provide information that would reduce participants’ uncertainty about their illness/treatment, to enhance coping in productive ways.
477402|NCT00416520|B3|Baseline|Total|Total of all reporting groups
477403|NCT00416520|B2|Baseline|Sevelamer (Open-label Period)|
477404|NCT00416520|B1|Baseline|MCI-196 (Open-label Period)|
477405|NCT00416520|P4|Participant Flow|Placebo (Placebo-controlled Withdrawal Period)|"dose level at the end of dose titration in the flexible dose period~There was a gap of 1 subject between STARTED and Overall Number of Baseline Participants One subject did not take any study medication and excluded from Baseline Participants."
477406|NCT00416520|P3|Participant Flow|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
477407|NCT00416520|P2|Participant Flow|Sevelamer (Open-label Period)|"2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated~There was a gap of 2 subjects between STARTED and Overall Number of Baseline Participants.~Three subjects in Sevelamer group were randomised in error and did not take any study medication. These 3 subjects were excluded from Baseline Participants of Sevelamer group.~However, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
477506|NCT00416182|P2|Participant Flow|Placebo|2.5mg/2.5mL placebo administered intranasally once daily
477408|NCT00416520|P1|Participant Flow|MCI-196 (Open-label Period)|"3, 6, 9, 12, or 15g/day as titrated~There was a gap of 3 subjects between STARTED and Overall Number of Baseline Participants.~Two subjects were randomised to receive MCI-196, but did not take study medication. These 2 subjects were excluded from Baseline Participants of MCI-196 group.~In addition, one subject (A) was randomised to receive MCI-196, but took sevelamer instead. This subject was counted as MCI-196 group for STARTED but counted as Sevelamer group for Baseline Participants."
477409|NCT00416520|O2|Outcome|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
477410|NCT00416520|O1|Outcome|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
477411|NCT00416520|O2|Outcome|Placebo (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
477412|NCT00416520|O1|Outcome|MCI-196 (Placebo-controlled Withdrawal Period)|dose level at the end of dose titration in the flexible dose period
477413|NCT00416520|E4|Reported Event|Placebo (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
477414|NCT00416520|E3|Reported Event|MCI-196 (Placebo-Controlled Period)|dose level at the end of dose titration in the flexible dose period
477415|NCT00416520|E2|Reported Event|Sevelamer (Open-label Period)|2.4, 4.8, 7.2, 9.6, or 12.0g/day as titrated
477416|NCT00416520|E1|Reported Event|MCI-196 (Open-label Period)|3, 6, 9, 12, or 15g/day as titrated
477417|NCT00416494|B3|Baseline|Total|Total of all reporting groups
477418|NCT00416494|B2|Baseline|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477419|NCT00416494|B1|Baseline|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477420|NCT00416494|P2|Participant Flow|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477421|NCT00416494|P1|Participant Flow|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477422|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477423|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477424|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477425|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477426|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477427|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477428|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477429|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477430|NCT00416494|O2|Outcome|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477431|NCT00416494|O1|Outcome|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477432|NCT00416494|E2|Reported Event|Second Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 850 mg/m2 in second cohort"
477433|NCT00416494|E1|Reported Event|Initial Cohort|"oxaliplatin : 85 mg/m2 intravenously over 2 hours on day 1.~Capecitabine : Oral administration every 12 hours on days 1-5 and 8-12 1000 mg/m2 in initial cohort~bevacizumab : 10 mg/kg intravenously over 30-90 minutes on day 1"
477434|NCT00416455|B3|Baseline|Total|Total of all reporting groups
477435|NCT00416455|B2|Baseline|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477436|NCT00416455|B1|Baseline|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477437|NCT00416455|P2|Participant Flow|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477438|NCT00416455|P1|Participant Flow|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477439|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477440|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477441|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477442|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477443|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477444|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477445|NCT00416455|O2|Outcome|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477446|NCT00416455|O1|Outcome|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477447|NCT00416455|E2|Reported Event|Endometrial Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477448|NCT00416455|E1|Reported Event|Cervical Cancer Patients|PET/CT 60 minutes after FDG IV on day 1; Combidex IV over 30 – 45 minutes, day 1 (or 24-36 hours before MRI). MRI on day 2; Extraperitoneal, laparoscopic, or trans-peritoneal lymphadenectomy with pelvic and abdominal lymph node biopsy within 2 weeks after PET/CT scan
477449|NCT00415532|B3|Baseline|Total|Total of all reporting groups
477450|NCT00415532|B2|Baseline|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477451|NCT00415532|B1|Baseline|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477452|NCT00415532|P2|Participant Flow|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477453|NCT00415532|P1|Participant Flow|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477454|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477455|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477456|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477457|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477458|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477459|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477460|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477461|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477462|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477463|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477464|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477465|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477466|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
482383|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
477467|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477468|NCT00415532|O2|Outcome|Romiplostim|Romiplostim administered by subcutaneous injection once weekly at a starting dose of 3 μg/kg, adjusted to a maximum dose of 10 μg/kg to maintain a platelet count between 50 and 200 x 10^9/L for up to 52 weeks.
477469|NCT00415532|O1|Outcome|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477470|NCT00415532|E2|Reported Event|AMG 531|
477471|NCT00415532|E1|Reported Event|Standard of Care|Medical standard of care treatments were selected and prescribed by the investigator according to standard institutional practices or therapeutic guidelines and administered for up to 52 weeks.
477472|NCT00415506|B3|Baseline|Total|Total of all reporting groups
477473|NCT00415506|B2|Baseline|Orbital Inflammation|Subjects with Orbital Inflammation
477474|NCT00415506|B1|Baseline|Scleritis|Subjects with Scleritis
477475|NCT00415506|P2|Participant Flow|Orbital Inflammation|Patients with non-infectious orbital inflammatory disease, and is a phase I, prospective clinical trial to examine the safety of the 2 infusions of rituximab intravenously, 2 weeks apart, in the treatment of non-infectious orbital inflammation. The first 5 patients will receive 1000 mg of rituximab at each infusion, any additional patients will be randomized to receive either 500 mg or 1000 mg of rituximab.
477476|NCT00415506|P1|Participant Flow|Scleritis|Patients with non-infectious scleritis and is a phase II, randomized, double-blinded, prospective clinical trial of two different doses of rituximab to compare the safety and efficacy of these 2 doses. Patients will be randomized to either 500 mg or 1000 mg of rituximab administered intravenously two weeks apart.
477477|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
477478|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
477479|NCT00415506|O2|Outcome|Orbital Inflammation|Subjects with Orbital Inflammation
477480|NCT00415506|O1|Outcome|Scleritis|Subjects with Scleritis
477481|NCT00415506|E2|Reported Event|Scleritis|Subjects with Scleritis
477482|NCT00415506|E1|Reported Event|Orbital Inflammation|Subjects with Orbital Inflammation
477483|NCT00415493|B3|Baseline|Total|Total of all reporting groups
477484|NCT00415493|B2|Baseline|Controls|normal subjects
477485|NCT00415493|B1|Baseline|Cases|non-allergic rhinitis subjects
477486|NCT00415493|P2|Participant Flow|Warm-moist Air Followed by Cold-dry Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Warm-moist air followed (on a separate day) by Cold-dry air. Exposures lasted 15 minutes, with a one-hour follow-up period.
477487|NCT00415493|P1|Participant Flow|Cold-dry Air Followed by Warm-moist Air|To control for possible stimulus-order effects, half of the subjects were evaluated pre- and post-exposure to Cold-dry air followed (on a separate day) by Warm-moist air. Exposures lasted 15 minutes, with a one-hour follow-up period.
477488|NCT00415493|O2|Outcome|Controls|normal subjects
477489|NCT00415493|O1|Outcome|Cases|non-allergic rhinitis subjects
477490|NCT00415493|E2|Reported Event|Controls|normal subjects
477491|NCT00415493|E1|Reported Event|Cases|non-allergic rhinitis subjects
477492|NCT00416195|B3|Baseline|Total|Total of all reporting groups
477493|NCT00416195|B2|Baseline|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
477494|NCT00416195|B1|Baseline|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
477495|NCT00416195|P2|Participant Flow|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
477496|NCT00416195|P1|Participant Flow|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
477497|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
477498|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
477499|NCT00416195|O2|Outcome|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
477500|NCT00416195|O1|Outcome|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
477501|NCT00416195|E2|Reported Event|Perampanel|2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase [Days 71 to 84] and a 4-week Maintenance Phase [Days 85 to 112])
477502|NCT00416195|E1|Reported Event|Placebo|Matching placebo once daily for 16 weeks (Days 1 to 112)
477503|NCT00416182|B3|Baseline|Total|Total of all reporting groups
477504|NCT00416182|B2|Baseline|Placebo|2.5 mL of placebo comparator
477505|NCT00416182|B1|Baseline|Pulmozyme (Dornase Alfa)|2.5 mg/2.5 mL of intranasal Pulmozyme
482384|NCT00402987|O4|Outcome|Placebo|
477507|NCT00416182|P1|Participant Flow|Pulmozyme (Dornase Alfa)|2.5 mg/2.5mL of Pulmozyme administered intranasally once daily
477508|NCT00416182|O2|Outcome|Placebo|Percent predicted forced expiratory volume in 1 second recorded
477509|NCT00416182|O1|Outcome|Pulmozyme|Percent predicted for forced expiratory volume in 1 second recorded
477510|NCT00416182|O2|Outcome|Placebo|Scores from the Chronic Sinusitis Survey recorded
477511|NCT00416182|O1|Outcome|Pulmozyme|Scores from the Chronic Sinusitis Survey
477512|NCT00416182|O2|Outcome|Placebo|endoscopic photos of sinuses by ENT surgeon, independently and blindly scored by two surgeons. Scores of 0,1,2 based on disease severity.
477513|NCT00416182|O1|Outcome|Pulmozyme|endoscopic photos of sinuses by ENT surgeon independently and blindly scored by two surgeons with scale of 0,1,2 to indicate severity of disease
477514|NCT00416182|O2|Outcome|Placebo|Patients receiving intranasal placebo once daily
477515|NCT00416182|O1|Outcome|Pulmozyme|Patients receiving 2.5 mg intranasal Pulmozyme once daily
477516|NCT00416182|E2|Reported Event|Placebo|patients receiving once daily intranasal placebo
477517|NCT00416182|E1|Reported Event|Pulmozyme|patients receiving once daily intranasal Pulmozyme
477518|NCT00416078|B3|Baseline|Total|Total of all reporting groups
477519|NCT00416078|B2|Baseline|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year customary care
477520|NCT00416078|B1|Baseline|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477521|NCT00416078|P2|Participant Flow|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477522|NCT00416078|P1|Participant Flow|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477523|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477524|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477525|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477526|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477527|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477528|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477529|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477530|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477531|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477532|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477533|NCT00416078|O2|Outcome|Caregiver Phone Calls|relative supportive telephone calls for six months embedded in one year of customary care
477534|NCT00416078|O1|Outcome|Caregiver Website|relative access to website support for 6 months embedded in one year of customary care
477535|NCT00416078|E2|Reported Event|Caregiver Brief Supportive Phone Calls|caregiver brief supportive telephone calls for 6 months embedded in one year of customary care
477536|NCT00416078|E1|Reported Event|Caregiver Website Support|caregiver access to website support for 6 months embedded in one year of customary care
477537|NCT00415909|B1|Baseline|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
477538|NCT00415909|P1|Participant Flow|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy. Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~T Acute Lymphoblastic Leukemia/Lymphoma (TALL)-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
477539|NCT00415909|O1|Outcome|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
477540|NCT00415909|E1|Reported Event|TALL-104 + IM|"TALL-104 cells and imatinib mesylate (IM) therapy~Imatinib Mesylate (IM): IM Therapy of (100 mg or 400 mg) tablets by mouth, same dose each day.~TALL-104 cells: TALL-104 cells will be given intravenously over 1 hour at the dose of 109 cells daily for 4 days, on days 1 to 4 of the cycle, and then again on days 7, 10, 14, 17 and 21 of the cycle. One cycle is equal to 28 days. Patients will receive only one cycle of therapy with TALL-104 cells"
477541|NCT00415870|B3|Baseline|Total|Total of all reporting groups
477542|NCT00415870|B2|Baseline|PACE: Intervention - SMS Messages and Lifestyle Counseling|
477543|NCT00415870|B1|Baseline|Control: Enhanced Usual Care|
477544|NCT00415870|P2|Participant Flow|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
477545|NCT00415870|P1|Participant Flow|Control|
477546|NCT00415870|O2|Outcome|PACE: Intervention - SMS Messages|
477547|NCT00415870|O1|Outcome|Control:Enhanced Usual Care|
477582|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477654|NCT00414973|P4|Participant Flow|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477548|NCT00415870|E2|Reported Event|PACE|"Received text messages and counseling calls~Food Monitoring : Food Monitoring~Text Message : Text Message~Cell phone will serve as a self monitoring device : Cell phone will serve as a self monitoring device~Diet Goals via Cell Phone : Diet Goals via Cell Phone~Weekly Weighing : Weekly Weighing~Printed Material : Printed Material"
477549|NCT00415870|E1|Reported Event|Control|
477550|NCT00415857|B3|Baseline|Total|Total of all reporting groups
477551|NCT00415857|B2|Baseline|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
477552|NCT00415857|B1|Baseline|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
477553|NCT00415857|P2|Participant Flow|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
477554|NCT00415857|P1|Participant Flow|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
477555|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
477556|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
477557|NCT00415857|O2|Outcome|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
477558|NCT00415857|O1|Outcome|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
477559|NCT00415857|E2|Reported Event|PR1 + Imatinib + Interferon|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination, and Peginterferon alfa-2b 0.5 microg/kg subcutaneous injection with each PR1 vaccination.
477560|NCT00415857|E1|Reported Event|PR1 + Imatinib|PR1 peptide administered dose 0.5 mg on weeks 0, 3, 6 and 18 for a total of 4 doses, with oral Imatinib at same dose received during last 6 months. Granulocyte-macrophage colony-stimulating factor (GM-CSF) 75 micrograms subcutaneously in same vaccine area with every vaccination.
477561|NCT00415623|B3|Baseline|Total|Total of all reporting groups
477562|NCT00415623|B2|Baseline|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477563|NCT00415623|B1|Baseline|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477564|NCT00415623|P2|Participant Flow|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477565|NCT00415623|P1|Participant Flow|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477566|NCT00415623|O3|Outcome|Week 8|
477567|NCT00415623|O2|Outcome|Week 4|
477568|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
477569|NCT00415623|O3|Outcome|Week 8|
477570|NCT00415623|O2|Outcome|Week 4|
477571|NCT00415623|O1|Outcome|Baseline|After once daily administration of amlodipine 5 mg for 8 weeks in the screening period
477572|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477573|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477574|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477575|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477576|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477577|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477578|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477579|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477580|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477581|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477583|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477584|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477585|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477586|NCT00415623|O2|Outcome|Amlodipine 10 mg|Two amlodipine besilate 5 mg tablets were administered once daily after breakfast for 8 weeks.
477587|NCT00415623|O1|Outcome|Amlodipine 5 mg|One amlodipine besilate 5 mg tablet and 1 amlodipine besilate 5 mg placebo tablet were administered once daily after breakfast for 8 weeks.
477588|NCT00415610|B4|Baseline|Total|Total of all reporting groups
477589|NCT00415610|B3|Baseline|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 110 to 140 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477590|NCT00415610|B2|Baseline|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 140 to 170 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477591|NCT00415610|B1|Baseline|Tier 1|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine to a range between 170 to 200 mmHg. Treatment with nicardipine must begin within 6 hours of symptom onset and will continue for an estimated 18 - 24 hours, until SBP is stabilized. The assigned SBP range will be maintained for 24 hours. After 24 hours, management of blood pressure is at the discretion of the primary physician.~nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477592|NCT00415610|P3|Participant Flow|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477593|NCT00415610|P2|Participant Flow|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477594|NCT00415610|P1|Participant Flow|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477595|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477596|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477613|NCT00415194|B3|Baseline|Total|Total of all reporting groups
477655|NCT00414973|P3|Participant Flow|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477597|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477598|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477599|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477600|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477601|NCT00415610|O3|Outcome|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477602|NCT00415610|O2|Outcome|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477603|NCT00415610|O1|Outcome|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477604|NCT00415610|E3|Reported Event|Tier 3|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 110 to 140 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued."
477605|NCT00415610|E2|Reported Event|Tier 2|"Dose escalation:~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 140 to 170 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477606|NCT00415610|E1|Reported Event|Tier 1|"Dose escalation: Initial range~The scientists will investigate the potential consequences of controlling blood pressure with intravenous nicardipine at 170 to 200 mmHg~Nicardipine: Intravenous (IV) nicardipine infusion. It is expected that the treatment duration will vary between 18 and 24 hours.~Started at 5mg/h~Titrated by 2.5mg/hour every 15 minutes to bring systolic blood pressure in target range for the applicable Tier. Max dose 15mg/hour *Once target systolic blood pressure reached, dose decreased by 2.5mg/hour every 15 minutes until systolic blood pressure maintained in the target range or the medication is discontinued.~The DSMB will review safety, tolerability, and feasibility before escalation to the next level."
477607|NCT00415597|B1|Baseline|ALO-01|
477608|NCT00415597|P1|Participant Flow|ALO-01|
477609|NCT00415597|O1|Outcome|ALO-01|
477610|NCT00415597|O1|Outcome|ALO-01|
477611|NCT00415597|O1|Outcome|ALO-01|
477612|NCT00415597|E1|Reported Event|ALO-01|
477614|NCT00415194|B2|Baseline|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477615|NCT00415194|B1|Baseline|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477616|NCT00415194|P2|Participant Flow|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477617|NCT00415194|P1|Participant Flow|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477618|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477619|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477620|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477621|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477622|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477623|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477624|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477651|NCT00414973|B3|Baseline|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477652|NCT00414973|B2|Baseline|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
477653|NCT00414973|B1|Baseline|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477625|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477626|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477627|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477628|NCT00415194|O2|Outcome|Placebo/Cisplatin|"Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m^2 on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477629|NCT00415194|O1|Outcome|Pemetrexed/Cisplatin|"Pemetrexed 500 milligrams per meter square (mg/m^2) administered intravenously (IV) plus cisplatin 75 mg/m^2 IV on Day 1 every 21 days.~Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment.~Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose.~Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose."
477630|NCT00415194|E2|Reported Event|Placebo/Cisplatin|Placebo (approximately 100 mL normal saline) administered IV plus cisplatin 75 mg/m2 on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
477631|NCT00415194|E1|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meter square (mg/m2) administered intravenously (IV) plus cisplatin 75 mg/m2 IV on Day 1 every 21 days. Pretreatment - Both Treatment Arms: Dexamethasone administered orally (po): 4 milligrams (mg) twice daily (BID) taken on the day before, the day of, and day after study treatment. Vitamin B12 administered intramuscularly (im): 1000 micrograms (μg) taken 1 to 2 weeks before treatment and every 9 weeks until 3 weeks after last treatment dose. Folic Acid administered orally (po): 350 μg to 1000 μg taken 1 to 2 weeks before treatment and continue daily until 3 weeks after last treatment dose.
477632|NCT00415168|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477633|NCT00415168|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477634|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477635|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477636|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477637|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477638|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477639|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477640|NCT00415168|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477641|NCT00415168|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 700 milligrams/meters squared (mg/m2) plus cisplatin 75 mg/m2, intravenous (IV), every 21 days for 6 cycles
477642|NCT00415051|B1|Baseline|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477643|NCT00415051|P1|Participant Flow|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477644|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477645|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477646|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477647|NCT00415051|O1|Outcome|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477648|NCT00415051|E1|Reported Event|Single Group Assignment|"RVF MP-12~RVF MP-12: Administer 1 ml SQ"
477649|NCT00414973|B5|Baseline|Total|Total of all reporting groups
477650|NCT00414973|B4|Baseline|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477656|NCT00414973|P2|Participant Flow|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
477657|NCT00414973|P1|Participant Flow|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477658|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477659|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477660|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477661|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477662|NCT00414973|O2|Outcome|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477663|NCT00414973|O1|Outcome|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477664|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
477665|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477666|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
477667|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477668|NCT00414973|O2|Outcome|Calcitonin - Females|Intranasal, 200 IU/day, 24 weeks
477669|NCT00414973|O1|Outcome|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477670|NCT00414973|E4|Reported Event|Calcitonin - Males|Intranasal, 200 IU/day, 24 weeks
477671|NCT00414973|E3|Reported Event|Teriparatide - Males|Subcutaneous, 20 micrograms/day, 24 weeks
477672|NCT00414973|E2|Reported Event|Calcitonin - Females|Intranasal, 200 International Units (IU)/day, 24 weeks
477673|NCT00414973|E1|Reported Event|Teriparatide - Females|Subcutaneous, 20 micrograms/day, 24 weeks
477674|NCT00414908|B3|Baseline|Total|Total of all reporting groups
477675|NCT00414908|B2|Baseline|Placebo (DB)|Placebo group given during the Double-Blind period
477676|NCT00414908|B1|Baseline|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477677|NCT00414908|P2|Participant Flow|Placebo (DB)|Placebo group given during the Double-Blind period
477678|NCT00414908|P1|Participant Flow|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477679|NCT00414908|O1|Outcome|Pancrelipase (OL)|Pancrelipase delayed during Open-label. Dosing is directed by the investigator.
477680|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477681|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477682|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477683|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477684|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477685|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477686|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477687|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477688|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477689|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477690|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477691|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477692|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477693|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477694|NCT00414908|O2|Outcome|Placebo (DB)|Placebo group given during the Double-Blind period
477695|NCT00414908|O1|Outcome|Pancrelipase (DB)|Pancrelipase delayed release capsules given during the Double-Blind period
477696|NCT00414908|E3|Reported Event|Pancrelipase (OL)|Pancrelipase delayed capsules received by the patients during the 6-month Open Label. The dosing was directed by the investigator.
477697|NCT00414908|E2|Reported Event|Placebo (DB)|Placebo group meaning the treatment received during the 7-days double-blind period
477698|NCT00414908|E1|Reported Event|Pancrelipase (DB)|Pancrelipase delayed release capsules meaning the treatment received during the 7-days double-blind period
477699|NCT00414817|B3|Baseline|Total|Total of all reporting groups
477700|NCT00414817|B2|Baseline|Usual Care|usual care participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
477701|NCT00414817|B1|Baseline|Automated Phone-Based Refill Reminders|Intervention arm participants who were included in the primary outcome analysis. This consists of existing users of inhaled corticosteroids at the outset of the study, qualified (or for UC would have qualified) for an intervention call at some point during the study, had at least 3 months of follow-up, and were not subsequently determined to be daily oral steroid users.
477702|NCT00414817|P2|Participant Flow|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
477703|NCT00414817|P1|Participant Flow|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
477704|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
477705|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
477706|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
477707|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
477708|NCT00414817|O2|Outcome|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
477709|NCT00414817|O1|Outcome|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
477710|NCT00414817|E2|Reported Event|Usual Care|"Usual Care: Participants randomly assigned to this arm received the same introductory letter as those in the intervention arm, giving them the opportunity to opt out, but were subsequently selected to be in the usual care study arm, and therefore, receive no intervention."
477711|NCT00414817|E1|Reported Event|Automated Phone-Based Refill Reminders|"Intervention Arm: Participants randomly assigned to this study arm may receive up to 8 automated phone calls from the BREATH EASY Medication Reminder Program over the course of the 19 month intervention period.~Automated Phone-Based Refill Reminders : The BREATHE EASY Medication Reminder Program uses interactive voice recognition phone technology to offer timely reminders to patients to refill their ICS medication, educational messages about ICS, and may offer to transfer them to a refill line or to speak with a pharmacist if they have questions."
477712|NCT00414726|B3|Baseline|Total|Total of all reporting groups
477713|NCT00414726|B2|Baseline|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
477714|NCT00414726|B1|Baseline|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
477715|NCT00414726|P2|Participant Flow|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
477716|NCT00414726|P1|Participant Flow|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
477717|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
477718|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
477719|NCT00414726|O2|Outcome|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
477720|NCT00414726|O1|Outcome|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
477721|NCT00414726|E2|Reported Event|Room Air|Room Air, inhaled at 30-45L/min via a facemask for 8 hours
477722|NCT00414726|E1|Reported Event|Normobaric Oxygen|Oxygen, inhaled at 30-45L/min via a facemask for 8 hours
477723|NCT00414700|B3|Baseline|Total|Total of all reporting groups
477724|NCT00414700|B2|Baseline|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477725|NCT00414700|B1|Baseline|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477726|NCT00414700|P2|Participant Flow|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477727|NCT00414700|P1|Participant Flow|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477728|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477729|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477730|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477731|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477766|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477767|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477732|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477733|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477734|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477735|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477736|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477737|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477738|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477739|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477740|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477741|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477742|NCT00414700|O2|Outcome|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477743|NCT00414700|O1|Outcome|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477744|NCT00414700|E2|Reported Event|Microfracture|Microfracture is a surgical technique involving several systematic steps, including debridement to a stable cartilage margin, careful removal of the calcified cartilage layer, and homogeneous placement of microfracture penetrations within the cartilage defect with resultant complete defect fill by a well-anchored mesenchymal clot.
477745|NCT00414700|E1|Reported Event|ChondroCelect|ChondroCelect is intended for use in autologous cartilage repair and is administered to patients in an Autologous Chondrocyte Implantation procedure (ACI)
477746|NCT00414661|B5|Baseline|Total|Total of all reporting groups
477747|NCT00414661|B4|Baseline|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477748|NCT00414661|B3|Baseline|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477749|NCT00414661|B2|Baseline|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477750|NCT00414661|B1|Baseline|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477751|NCT00414661|P4|Participant Flow|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477752|NCT00414661|P3|Participant Flow|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477753|NCT00414661|P2|Participant Flow|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477754|NCT00414661|P1|Participant Flow|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477755|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477756|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477757|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477758|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477759|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477760|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477761|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477762|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477763|NCT00414661|O4|Outcome|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477764|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477765|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477768|NCT00414661|O3|Outcome|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477769|NCT00414661|O2|Outcome|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477770|NCT00414661|O1|Outcome|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477771|NCT00414661|E4|Reported Event|Adalimumab|Participants who had received 1 dose of adalimumab in any of the previous studies.
477772|NCT00414661|E3|Reported Event|Placebo|Participants who had received 1 dose of matching-placebo in any of the previous studies.
477773|NCT00414661|E2|Reported Event|CP-690,550 <10 mg|Participants who had received 1 dose CP-690,550 less than (<) 10 mg orally twice daily in any of the previous studies.
477774|NCT00414661|E1|Reported Event|CP-690,550 >=10 mg|Participants who had received 1 dose CP-690,550 greater than or equal to (>=) 10 milligram (mg) orally twice daily in any of the previous studies.
477775|NCT00414635|B3|Baseline|Total|Total of all reporting groups
477776|NCT00414635|B2|Baseline|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477777|NCT00414635|B1|Baseline|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477778|NCT00414635|P2|Participant Flow|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477779|NCT00414635|P1|Participant Flow|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477780|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477781|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477782|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477783|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477784|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477785|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477786|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477787|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477788|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477789|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477790|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477791|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477792|NCT00414635|O2|Outcome|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477793|NCT00414635|O1|Outcome|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477794|NCT00414635|E2|Reported Event|Control|Daily regimen (7 days)• The control arm will take their antiretrovirals for 7 days a week for the first 24 weeks and then cross over to the 5/2 intermittent treatment schedule (if their HIV RNA remains undetectable on an ultrasensitive assay) for the remainder of the study.
477831|NCT00414596|E1|Reported Event|DRX Group|Patients using the device DRX9000™.
478117|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
477795|NCT00414635|E1|Reported Event|FOTO|Participants changing to 5 days on, 2 days off (FOTO). The 5/2 intermittent treatment arm will take their antiretrovirals for 5 consecutive days followed by 2 days off for 48 weeks (provided their HIV RNA remains undetectable on an ultrasensitive assay).
477796|NCT00414609|B3|Baseline|Total|Total of all reporting groups
477797|NCT00414609|B2|Baseline|Aliskiren|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477798|NCT00414609|B1|Baseline|Placebo|Placebo for 36 weeks once daily in the morning
477799|NCT00414609|P3|Participant Flow|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477800|NCT00414609|P2|Participant Flow|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477801|NCT00414609|P1|Participant Flow|Placebo_Core|Placebo for 36 weeks once daily in the morning
477802|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477803|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477804|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477805|NCT00414609|O1|Outcome|Aliskiren_Extension|150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study.
477806|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477807|NCT00414609|O1|Outcome|Aliskiren_Extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477808|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477809|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477810|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477811|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477812|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477813|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477814|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477815|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477816|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477817|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477818|NCT00414609|O2|Outcome|Aliskiren_Core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477819|NCT00414609|O1|Outcome|Placebo_Core|Placebo for 36 weeks once daily in the morning
477820|NCT00414609|E3|Reported Event|Aliskiren_extension|"Patients from both the arms of the core study who completed core study and signed informed consent form were included in this arm of extension study.~Patients received 150 mg aliskiren tablet orally once a day for two weeks. Patients were then up-titrated to 300 mg aliskiren orally once a day at the discretion of the principal investigator based on their clinical condition for the duration of the study."
477821|NCT00414609|E2|Reported Event|Aliskiren_core|Aliskiren ascending doses: 75 mg tablet for 1st week, 150 mg for 2nd week, 300 mg for the next 34 weeks orally once daily in the morning.
477822|NCT00414609|E1|Reported Event|Placebo_core|Placebo for 36 weeks once daily in the morning
477823|NCT00414596|B1|Baseline|DRX Group|Patients using the device DRX9000™.
477824|NCT00414596|P1|Participant Flow|DRX Group|Patients using the device DRX9000™.
477825|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477826|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477827|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477828|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477829|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477830|NCT00414596|O1|Outcome|DRX Group|Patients using the device DRX9000™.
477832|NCT00414544|B1|Baseline|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
477833|NCT00414544|P1|Participant Flow|CosmetaLife vs Restylane|Split-face double blind study design used so each subject received each treatment followed by a two week touch up treatment, where no subject received more than 2cc of either CosmetaLife or Restylane treatment.
477834|NCT00414544|O2|Outcome|Restylane (Control)|Restylane (Control) injected nasolabial fold contralateral side
477835|NCT00414544|O1|Outcome|CosmetaLife|CosmetaLife injected nasolabial fold side
477836|NCT00414544|E2|Reported Event|Restylane (Control)|
477837|NCT00414544|E1|Reported Event|CosmetaLife|
477838|NCT00414518|B3|Baseline|Total|Total of all reporting groups
477839|NCT00414518|B2|Baseline|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477840|NCT00414518|B1|Baseline|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477841|NCT00414518|P2|Participant Flow|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477842|NCT00414518|P1|Participant Flow|Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477843|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapy|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477844|NCT00414518|O1|Outcome|12 Week Treatment Folllowed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477845|NCT00414518|O2|Outcome|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477846|NCT00414518|O1|Outcome|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477847|NCT00414518|O2|Outcome|CD4 T Cell Guided Therapyh|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477848|NCT00414518|O1|Outcome|12 Week Treatment Arm Followed by Treatment Interruption|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477849|NCT00414518|E2|Reported Event|Arm B|Antiretroviral therapy (ART) will not be initiated until AIDS-defining illness occurs or if CD4 is confirmed at less than 350 mm^3 at two separate, consecutive measurements
477850|NCT00414518|E1|Reported Event|Arm A|Oral tenofovir/emcitribine (TDF/FTC) and lopinavir/ritonavir(LPV/RTV) for 12 weeks followed by treatment interruption if CD4 count is 450 mm^3 or higher. When CD4 count is less than 350 mm^3 on two separate, consecutive measurements during treatment interruption, therapy will be resumed.
477851|NCT00414466|B5|Baseline|Total|Total of all reporting groups
477852|NCT00414466|B4|Baseline|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477853|NCT00414466|B3|Baseline|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477854|NCT00414466|B2|Baseline|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477855|NCT00414466|B1|Baseline|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477856|NCT00414466|P4|Participant Flow|4 Gabapentin High (30mg/Day)|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477857|NCT00414466|P3|Participant Flow|3 Gabapentin Medium (6mg/Day)|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477858|NCT00414466|P2|Participant Flow|2 Gabapentin Low (1mg/Day)|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477859|NCT00414466|P1|Participant Flow|1 Placebo (0mg/Day)|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477860|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477861|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477862|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477863|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477864|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477865|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
482385|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
477866|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477867|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477868|NCT00414466|O4|Outcome|4 Gabapentin High|Intraspinal Gabapentin High (30mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477869|NCT00414466|O3|Outcome|3 Gabapentin Medium|Intraspinal Gabapentin Medium (6mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477870|NCT00414466|O2|Outcome|2 Gabapentin Low|Intraspinal Gabapentin Low (1mg/day) delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477871|NCT00414466|O1|Outcome|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477872|NCT00414466|E4|Reported Event|4 Gabapentin High|Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477873|NCT00414466|E3|Reported Event|3 Gabapentin Medium|Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477874|NCT00414466|E2|Reported Event|2 Gabapentin Low|Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days of infusion at half dose
477875|NCT00414466|E1|Reported Event|1 Placebo|Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system
477876|NCT00414453|B1|Baseline|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477877|NCT00414453|P1|Participant Flow|Lidocaine 5% + Placebo Patch, ER + Placebo Pills|"5% lidocaine patch used as intervention Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off~placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm Placebo lidocaine patches: used with extended release oxycodone group; used with placebo prandomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating scheduleills/placebo patches~placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477878|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477879|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477880|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477881|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477882|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477883|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477884|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477885|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477886|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477887|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477888|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477889|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477890|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477891|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477892|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477893|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477894|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477895|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477896|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477897|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477898|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477899|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477900|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477901|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477902|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477903|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477904|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477905|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477906|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477907|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477908|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477909|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477910|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477911|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477912|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477913|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477914|NCT00414453|O4|Outcome|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477915|NCT00414453|O3|Outcome|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477916|NCT00414453|O2|Outcome|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477917|NCT00414453|O1|Outcome|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477918|NCT00414453|E4|Reported Event|Placebo Pills|"placebo pills used with lidocaine 5% patch group and with placebo patch/placebo pill group~Placebo extended-release oxycodone pills: placebo pills with titrating schedule"
477919|NCT00414453|E3|Reported Event|Extended Release Oxycodone|"randomized subjects given extended release oxycodone and placebo patches during this treatment period~Extended-release oxycodone: extended-release oxycodone titrating schedule"
477920|NCT00414453|E2|Reported Event|Placebo Patch|"placebo patch used with extended release oxycodone or with placebo pills and placebo patches arm~Placebo lidocaine patches: used with extended release oxycodone group; used with placebo pills/placebo patches"
477921|NCT00414453|E1|Reported Event|Lidocaine Patch 5%|"5% lidocaine patch used as intervention~Lidocaine patch 5%: lidocaine 5% patch; 12 hours on, 12 hours off"
477922|NCT00414440|B3|Baseline|Total|Total of all reporting groups
477923|NCT00414440|B2|Baseline|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477924|NCT00414440|B1|Baseline|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477925|NCT00414440|P2|Participant Flow|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477926|NCT00414440|P1|Participant Flow|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477927|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477928|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477929|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477930|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477931|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477932|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477933|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477934|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477935|NCT00414440|O2|Outcome|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses.
477936|NCT00414440|O1|Outcome|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477937|NCT00414440|E2|Reported Event|Placebo|Placebo tablets equivalent to the dosage of everolimus 5 mg/day, divided in 2 equal doses
477938|NCT00414440|E1|Reported Event|Everolimus|Patients in the everolimus group initially received 5 mg/day everolimus divided in 2 equal doses (i.e. 2.5 mg b.i.d.). Dose adjustments were performed to achieve a blood trough level of 3-8 ng/mL (maximum daily dose: 10 mg/day [5 mg b.i.d.]).
477939|NCT00414388|B1|Baseline|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
477940|NCT00414388|P1|Participant Flow|Single Agent Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (docetaxel or mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m^2 and mitoxantrone was given at 12 mg/m^2, both once every 21 days and both combined with prednisone at 5mg twice daily. A maximum of 6 cycles of sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive sorafenib monotherapy until disease progression.
477941|NCT00414388|O1|Outcome|Sorafenib|Eligible patients were continued on the same chemotherapeutic regimen they had progressed on prior on entry into the study (Docetaxel or Mitoxantrone) with the addition of Sorafenib at 400mg twice daily. Docetaxel was given at 75 mg/m2 and Mitoxantrone was given at 12 mg/m2, both once every 21 days and both combined with Prednisone at 5mg twice daily. A maximum of 6 cycles of Sorafenib plus chemotherapy were allowed. Patients without objective disease progression after combination therapy was complete were allowed to receive Sorafenib monotherapy until disease progression.
477942|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
477943|NCT00414388|O1|Outcome|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
477944|NCT00414388|E1|Reported Event|Single Agent Sorafenib|Oral Single agent Sorafenib 400mg twice daily
477945|NCT00414310|B3|Baseline|Total|Total of all reporting groups
477946|NCT00414310|B2|Baseline|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
477947|NCT00414310|B1|Baseline|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
477948|NCT00414310|P2|Participant Flow|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
477949|NCT00414310|P1|Participant Flow|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
477950|NCT00414310|O2|Outcome|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
477951|NCT00414310|O1|Outcome|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
477952|NCT00414310|E2|Reported Event|Decitabine + Valproic Acid|Decitabine 20 mg/m^2 IV over 1 hour daily for 5 days. Valproic Acid 50 mg/kg orally daily for 7 days.
477953|NCT00414310|E1|Reported Event|Decitabine|Decitabine 20 mg/m^2 intravenous (IV) over 1 hour daily for 5 days.
477954|NCT00414206|B4|Baseline|Total|Total of all reporting groups
477955|NCT00414206|B3|Baseline|Placebo|
477956|NCT00414206|B2|Baseline|0.3% Mecamylamine|
477957|NCT00414206|B1|Baseline|1% Mecamylamine|
477958|NCT00414206|P3|Participant Flow|Placebo|
477959|NCT00414206|P2|Participant Flow|0.3% Mecamylamine|
477960|NCT00414206|P1|Participant Flow|1% Mecamylamine|
477961|NCT00414206|O3|Outcome|Placebo|
477962|NCT00414206|O2|Outcome|0.3% Mecamylamine|
477963|NCT00414206|O1|Outcome|1% Mecamylamine|
477964|NCT00414206|E3|Reported Event|Placebo|
477965|NCT00414206|E2|Reported Event|0.3% Mecamylamine|
477966|NCT00414206|E1|Reported Event|1% Mecamylamine|
477967|NCT00414167|B3|Baseline|Total|Total of all reporting groups
477968|NCT00414167|B2|Baseline|Placebo|"Placebo~Placebo : Placebo"
477969|NCT00414167|B1|Baseline|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
477970|NCT00414167|P2|Participant Flow|Placebo|"Placebo~Placebo : Placebo"
477971|NCT00414167|P1|Participant Flow|Bupropion (300 mg/d)|"Bupropion~bupropion : 300 mg per day for 8 weeks"
477972|NCT00414167|O2|Outcome|Placebo|"Placebo~Placebo : Placebo"
477973|NCT00414167|O1|Outcome|Bupropion|"Bupropion~bupropion : 300 mg per day for 8 weeks"
477974|NCT00414167|O2|Outcome|Placebo|
477975|NCT00414167|O1|Outcome|Bupropion|
477976|NCT00414167|E2|Reported Event|Placebo|
477977|NCT00414167|E1|Reported Event|Bupropion|
477978|NCT00414050|B5|Baseline|Total|Total of all reporting groups
477979|NCT00414050|B4|Baseline|ENGERIX-B|ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477980|NCT00414050|B3|Baseline|Modified Process Hepatitis B Vaccine 10 µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477981|NCT00414050|B2|Baseline|RECOMBIVAX™ Hepatitis B Vaccine|RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477982|NCT00414050|B1|Baseline|Modified Process Hepatitis B Vaccine, 5µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477983|NCT00414050|P4|Participant Flow|ENGERIX-B|ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477984|NCT00414050|P3|Participant Flow|Modified Process Hepatitis B Vaccine 10 µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477985|NCT00414050|P2|Participant Flow|RECOMBIVAX™ Hepatitis B Vaccine|RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477986|NCT00414050|P1|Participant Flow|Modified Process Hepatitis B Vaccine, 5µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477987|NCT00414050|O4|Outcome|ENGERIX-B|ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477988|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477989|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477990|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine, 5µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477991|NCT00414050|O4|Outcome|ENGERIX-B|ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477992|NCT00414050|O3|Outcome|Modified Process Hepatitis B Vaccine 10 µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477993|NCT00414050|O2|Outcome|RECOMBIVAX™ Hepatitis B Vaccine|RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477994|NCT00414050|O1|Outcome|Modified Process Hepatitis B Vaccine, 5µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477995|NCT00414050|E4|Reported Event|ENGERIX-B|ENGERIX-B given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477996|NCT00414050|E3|Reported Event|Modified Process Hepatitis B Vaccine 10 µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months
477997|NCT00414050|E2|Reported Event|RECOMBIVAX™ Hepatitis B Vaccine|RECOMBIVAX HB (currently licensed product) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477998|NCT00414050|E1|Reported Event|Modified Process Hepatitis B Vaccine, 5µg (Micrograms)|Modified Process Hepatitis B Vaccine (Experimental) given IM (Intramuscular) in 3 Injections of 5 ug (micrograms)/0.5 mL each over 4 months
477999|NCT00414011|B1|Baseline|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
478000|NCT00414011|P1|Participant Flow|Moxifloxacin/Gatifloxacin Treatment|"Both eyes were treated. Each participant was randomly assigned to either:~Group A: Moxifloxacin eyedrops on right eye; Gatifloxacin eyedrops on left eye~Group B: Gatifloxacin eyedrops on right eye; Moxifloxacin eyedrops on left eye~Eyedrops were given as 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery"
478001|NCT00414011|O2|Outcome|Gatifloxacin|Gatifloxacin eye drops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
478002|NCT00414011|O1|Outcome|Moxifloxacin|Moxifloxacin eyedrops; 1 drop 4 times daily for 1 week or until complete re-epithelization (usually 3-4 days) after surgery
478003|NCT00414011|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
478004|NCT00413972|B5|Baseline|Total|Total of all reporting groups
478005|NCT00413972|B4|Baseline|Placebo|
478006|NCT00413972|B3|Baseline|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
478007|NCT00413972|B2|Baseline|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
478008|NCT00413972|B1|Baseline|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
478009|NCT00413972|P4|Participant Flow|Placebo|
478010|NCT00413972|P3|Participant Flow|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
478011|NCT00413972|P2|Participant Flow|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
478012|NCT00413972|P1|Participant Flow|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
478013|NCT00413972|O4|Outcome|Placebo|
478014|NCT00413972|O3|Outcome|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
478015|NCT00413972|O2|Outcome|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
478016|NCT00413972|O1|Outcome|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
478017|NCT00413972|E4|Reported Event|Placebo|
478018|NCT00413972|E3|Reported Event|Vytorin 10/40|Ezetimibe 10 mg with Simvastatin 40 mg
478019|NCT00413972|E2|Reported Event|Vytorin 10/20|Ezetimibe 10 mg with Simvastatin 20 mg
478020|NCT00413972|E1|Reported Event|Vytorin 10/10|Ezetimibe 10 mg with Simvastatin 10 mg
478021|NCT00413959|B1|Baseline|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
478022|NCT00413959|P1|Participant Flow|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
478023|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
478024|NCT00413959|O1|Outcome|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
478025|NCT00413959|E1|Reported Event|Velcade, Rituximab,Cyclophosphamide & Decadron|Velcade 375 mg/m^2 given intravenously on days 1, 8, 15 and 22 during the first cycle then on day 1 of each subsequent cycle.
478026|NCT00413920|B3|Baseline|Total|Total of all reporting groups
478027|NCT00413920|B2|Baseline|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478028|NCT00413920|B1|Baseline|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478029|NCT00413920|P2|Participant Flow|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478030|NCT00413920|P1|Participant Flow|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478031|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478032|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478033|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478034|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478035|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478036|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478037|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478038|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478039|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478040|NCT00413920|O2|Outcome|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478041|NCT00413920|O1|Outcome|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478042|NCT00413920|E2|Reported Event|With Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, and subsequently continued to receive daily oral prednisone.
478043|NCT00413920|E1|Reported Event|Without Steroids|Patients received Enteric-coated Mycophenolate Sodium (EC-MPS), administered orally 2 times a day for 6 months. Patients also received cyclosporine and a dose of methylprednisolone immediately after transplantation, but did not subsequently receive oral corticosteroids for the remainder of the study.
478044|NCT00413894|B1|Baseline|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478057|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478045|NCT00413894|P1|Participant Flow|Methoxy Polyethylene Glycol-epoetin Beta (C.E.R.A)|During screening (Month -2 to -1), participants received their previous ESA (Erythropoiesis Stimulating Agent) (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 micrograms per month (μg/month) administered once monthly intravenously (IV). Doses were subsequently adjusted by investigator according to participant’s hemoglobin (Hb) values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478046|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478047|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478048|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478049|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478050|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478051|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478052|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478053|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478054|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478055|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478056|NCT00413894|O1|Outcome|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy C.E.R.A once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478086|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478058|NCT00413894|E1|Reported Event|C.E.R.A|During screening (Month -2 to -1), participants received their previous ESA (epoetin alfa/beta/delta or darbepoetin alfa) at previously applied dosing scheme. During titration (Month 1-5), participants received C.E.R.A. at a starting dose of 125 or 200 μg/month administered once monthly IV. Doses were subsequently adjusted by investigator according to participant’s hemoglobin values. During evaluation (Month 6 to 8), participants received methoxy polyethylene glycol-epoetin beta once monthly administered IV at a dose decided by investigator according to participant’s Hb values.
478059|NCT00413660|B8|Baseline|Total|Total of all reporting groups
478060|NCT00413660|B7|Baseline|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478061|NCT00413660|B6|Baseline|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478062|NCT00413660|B5|Baseline|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478063|NCT00413660|B4|Baseline|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478064|NCT00413660|B3|Baseline|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478065|NCT00413660|B2|Baseline|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478066|NCT00413660|B1|Baseline|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478067|NCT00413660|P11|Participant Flow|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478068|NCT00413660|P10|Participant Flow|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478069|NCT00413660|P9|Participant Flow|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478070|NCT00413660|P8|Participant Flow|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478071|NCT00413660|P7|Participant Flow|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478072|NCT00413660|P6|Participant Flow|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478073|NCT00413660|P5|Participant Flow|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478074|NCT00413660|P4|Participant Flow|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478075|NCT00413660|P3|Participant Flow|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478076|NCT00413660|P2|Participant Flow|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478077|NCT00413660|P1|Participant Flow|CP-690,550 1 mg|CP-690,550 1 milligram (mg) tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 percent (%) reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478078|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478079|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478080|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478081|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478082|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478083|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478084|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478085|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478115|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478116|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478087|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478088|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478089|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478090|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478091|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478092|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478093|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478094|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478095|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478096|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478097|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478098|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478099|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478100|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478101|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478102|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478103|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478104|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478105|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478106|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478107|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478108|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478109|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478110|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478111|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478112|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478113|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478114|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
482386|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
478118|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478119|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478120|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478121|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478122|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478123|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478124|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478125|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478126|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478127|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478128|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478129|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478130|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478131|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478132|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478133|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478134|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478135|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478136|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478137|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478138|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478139|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478140|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478141|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478142|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478143|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478144|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478145|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478205|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478146|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478147|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478148|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478149|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478150|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478151|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478152|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478153|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478154|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478155|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478156|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478157|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478158|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478159|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478160|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478161|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478162|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478163|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478164|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478165|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478166|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478167|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478168|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478169|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478170|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478171|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478172|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478173|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478174|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478175|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478176|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478177|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478178|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478179|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478180|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478181|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478182|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478183|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478184|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478185|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478186|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478187|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478188|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478189|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478190|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478191|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478192|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478193|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478194|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478195|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478196|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478197|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478198|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478199|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478200|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478201|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478202|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478203|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478204|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
482387|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
478206|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478207|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478208|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478209|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478210|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478211|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478212|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478213|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478214|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478215|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478216|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478217|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478218|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478219|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478220|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478221|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478222|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478223|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478224|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478225|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478226|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478227|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478228|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478229|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478230|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478231|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478232|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478233|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478293|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478234|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478235|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478236|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478237|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478238|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478239|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478240|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478241|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478242|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478243|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478244|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478245|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478246|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478247|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478248|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478249|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478250|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478251|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478252|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478253|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478254|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478255|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478256|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478257|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478258|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478259|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478260|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478261|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478262|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478263|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478264|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478265|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478266|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478267|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478268|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478269|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478270|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478271|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478272|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478273|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478274|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478275|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478276|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478277|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478278|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478279|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478280|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478281|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478282|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478283|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478284|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478285|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478286|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478287|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478288|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478289|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478290|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478291|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478292|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
482388|NCT00402987|O3|Outcome|Placebo|
478294|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478295|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478296|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478297|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478298|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478299|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478300|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478301|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478302|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478303|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478304|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478305|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478306|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478307|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478308|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478309|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478310|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478311|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478312|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478313|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478314|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478315|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478316|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478317|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478318|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478319|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478320|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478321|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478469|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
478322|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478323|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478324|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478325|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478326|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478327|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478328|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478329|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478330|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478331|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478332|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478333|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478334|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478335|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478336|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478337|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478338|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478339|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478340|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478341|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478342|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478343|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478344|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478345|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478346|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478347|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478348|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478349|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478350|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478351|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478352|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478353|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478354|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478355|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478356|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478357|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478358|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478359|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478360|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478361|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478362|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478363|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478364|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478365|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478366|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478367|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478368|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478369|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478370|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478371|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478372|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478373|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478374|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478375|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478376|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478377|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478378|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478379|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478380|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478470|NCT00413582|E2|Reported Event|PCA Group|IV narcotic analgesia arm of study
478381|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478382|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478383|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478384|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478385|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478386|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478387|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478388|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478389|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478390|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478391|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478392|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478393|NCT00413660|O11|Outcome|Placebo to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in placebo treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478394|NCT00413660|O10|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478395|NCT00413660|O9|Outcome|CP-690,550 20 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 20 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478396|NCT00413660|O8|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478397|NCT00413660|O7|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478398|NCT00413660|O6|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478399|NCT00413660|O5|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478400|NCT00413660|O4|Outcome|CP-690,550 3 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 3 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478401|NCT00413660|O3|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478402|NCT00413660|O2|Outcome|CP-690,550 1 mg to CP-690,550 5 mg (R)|Participants who failed to achieve minimum improvement in CP-690,550 1 mg treatment arm, after Week 12 visit received CP-690,550 5 mg tablet orally twice daily up to Week 24.
478403|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478404|NCT00413660|O7|Outcome|Placebo|Matching placebo tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20 % reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to Placebo to CP-690,550 5 mg (R) treatment arm for next 12 weeks.
478405|NCT00413660|O6|Outcome|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 20 mg to 5 mg (R) treatment arm for next 12 weeks.
478406|NCT00413660|O5|Outcome|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily for 24 weeks.
478407|NCT00413660|O4|Outcome|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily for 24 weeks.
478408|NCT00413660|O3|Outcome|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily for 24 weeks.
478409|NCT00413660|O2|Outcome|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 3 mg to 5 mg (R) treatment arm for next 12 weeks.
478471|NCT00413582|E1|Reported Event|Epidural Group|Epidural analgesia arm of study
478410|NCT00413660|O1|Outcome|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily for 24 weeks. Participants who failed to achieve a minimum improvement of at least 20% reduction in both swollen and tender joint counts over baseline at Week 12 visit were reassigned to CP-690,550 1 mg to 5 mg (R) treatment arm for next 12 weeks.
478411|NCT00413660|E11|Reported Event|Placebo to CP-690,550 5 mg (R)|Matching placebo tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
478412|NCT00413660|E10|Reported Event|Placebo|Matching placebo tablet orally twice daily up to Week 24.
478413|NCT00413660|E9|Reported Event|CP-690,550 20 mg to CP-690,550 5 mg (R)|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 12 followed by CP-690,550 5 mg tablet orally twice daily up to Week 24.
478414|NCT00413660|E8|Reported Event|CP-690,550 20 mg|CP-690,550 20 mg tablet orally once daily as morning dose and matching placebo tablet orally once daily as evening dose up to Week 24.
478415|NCT00413660|E7|Reported Event|CP-690,550 15 mg|CP-690,550 15 mg tablet orally twice daily up to Week 24.
478416|NCT00413660|E6|Reported Event|CP-690,550 10 mg|CP-690,550 10 mg tablet orally twice daily up to Week 24.
478417|NCT00413660|E5|Reported Event|CP-690,550 5 mg|CP-690,550 5 mg tablet orally twice daily up to Week 24.
478418|NCT00413660|E4|Reported Event|CP-690,550 3 mg to CP-690,550 5 mg (R)|CP-690,550 3 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
478419|NCT00413660|E3|Reported Event|CP-690,550 3 mg|CP-690,550 3 mg tablet orally twice daily up to Week 24.
478420|NCT00413660|E2|Reported Event|CP-690,550 1 mg to CP-690,550 5 mg (R)|CP-690,550 1 mg tablet orally twice daily up to Week 12 followed by CP-690,550 5 mg tablet orally twice up to Week 24.
478421|NCT00413660|E1|Reported Event|CP-690,550 1 mg|CP-690,550 1 mg tablet orally twice daily up to Week 24.
478422|NCT00413634|B3|Baseline|Total|Total of all reporting groups
478423|NCT00413634|B2|Baseline|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478424|NCT00413634|B1|Baseline|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478425|NCT00413634|P2|Participant Flow|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478426|NCT00413634|P1|Participant Flow|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478427|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478428|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478429|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478430|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478431|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478432|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478433|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478434|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478435|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478436|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478437|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478438|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478439|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478440|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478441|NCT00413634|O2|Outcome|Agrylin (Elderly)|Active metabolite of Agrylin (BCH24426) in ages 65 and older
478442|NCT00413634|O1|Outcome|Agrylin (Young)|Active metabolite of Agrylin (BCH24426) in ages 18-50
478443|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478444|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478445|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478446|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478447|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478448|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478449|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478450|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478451|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478452|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478453|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478454|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478455|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478456|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478457|NCT00413634|O2|Outcome|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478458|NCT00413634|O1|Outcome|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478459|NCT00413634|E2|Reported Event|Agrylin (Elderly)|Anagrelide hydrochloride in ages 65 and older
478460|NCT00413634|E1|Reported Event|Agrylin (Young)|Anagrelide hydrochloride in ages 18-50 years
478461|NCT00413582|B3|Baseline|Total|Total of all reporting groups
478462|NCT00413582|B2|Baseline|PCA Group|IV narcotic analgesia arm of study
478463|NCT00413582|B1|Baseline|Epidural Group|Epidural analgesia arm of study
478464|NCT00413582|P2|Participant Flow|PCA Group|IV narcotic analgesia arm of study
478465|NCT00413582|P1|Participant Flow|Epidural Group|Epidural analgesia arm of study
478466|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
478467|NCT00413582|O1|Outcome|Epidural Group|Epidural analgesia arm of study
478468|NCT00413582|O2|Outcome|PCA Group|IV narcotic analgesia arm of study
478472|NCT00413478|B1|Baseline|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
478473|NCT00413478|P1|Participant Flow|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
478474|NCT00413478|O1|Outcome|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
478475|NCT00413478|E1|Reported Event|5-Azacytidine|5-Azacytidine 75 mg/m^2 subcutaneously daily for 7 days, cycle repeated every 3-8 weeks.
478476|NCT00413413|B4|Baseline|Total|Total of all reporting groups
478477|NCT00413413|B3|Baseline|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478478|NCT00413413|B2|Baseline|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478479|NCT00413413|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478480|NCT00413413|P3|Participant Flow|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478481|NCT00413413|P2|Participant Flow|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478482|NCT00413413|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478483|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478484|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478485|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478486|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478487|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478488|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478489|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478490|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478491|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478492|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478493|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478494|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478495|NCT00413413|O3|Outcome|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478496|NCT00413413|O2|Outcome|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478497|NCT00413413|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478498|NCT00413413|E3|Reported Event|Valsartan 160 mg|1 valsartan 160 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478499|NCT00413413|E2|Reported Event|Valsartan 80 mg|1 valsartan 80 mg capsule, 1 placebo tablet to match valsartan/amlodipine 80/5 mg once daily
478500|NCT00413413|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet, 1 placebo capsule to match valsartan once daily
478501|NCT00413400|B3|Baseline|Total|Total of all reporting groups
478502|NCT00413400|B2|Baseline|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478503|NCT00413400|B1|Baseline|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478504|NCT00413400|P2|Participant Flow|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478505|NCT00413400|P1|Participant Flow|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478506|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478507|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478508|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478509|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478510|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478511|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478512|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478513|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478514|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478515|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478516|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478517|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478518|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478519|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478520|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478521|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478522|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478523|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478524|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478525|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478526|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478527|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478528|NCT00413400|O2|Outcome|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478529|NCT00413400|O1|Outcome|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478530|NCT00413400|E2|Reported Event|Etanercept|Etanercept 50mg subcutaneously twice weekly x 3 months, then once weekly x 3 months
478531|NCT00413400|E1|Reported Event|Placebo|Placebo injections, subcutaneously, twice weekly x 3 months, then once weekly x 3 months
478532|NCT00413374|B1|Baseline|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
478533|NCT00413374|P1|Participant Flow|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
478534|NCT00413374|O1|Outcome|Recurrent Venous Thromboembolism|Participants receiving Enoxaparin once daily who developed a VTE (either a DVT or PE) within 30 days.
478535|NCT00413374|O1|Outcome|Major Bleeding Complication|Study participants receiving Enoxaparin once daily who developed a major bleeding complication within 30 days.
478536|NCT00413374|E1|Reported Event|Enoxaparin|"Recieved low molecular weight heparin (LMWH) as a bridge to warfarin"
478537|NCT00413335|B3|Baseline|Total|Total of all reporting groups
478538|NCT00413335|B2|Baseline|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478539|NCT00413335|B1|Baseline|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478540|NCT00413335|P2|Participant Flow|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478541|NCT00413335|P1|Participant Flow|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478542|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478543|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478544|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478545|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478546|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478547|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478548|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478549|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478550|NCT00413335|O2|Outcome|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478551|NCT00413335|O1|Outcome|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478552|NCT00413335|E2|Reported Event|Inactive Arm (Placebo)|"Subject has ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, DEXA, NMR. Subject is randomized (double-blind) to placebo. Is followed every 2 weeks, repeats imaging at 2 months, is seen at 12 weeks and then repeats all tests at 2 months.~Placebo : Subject receives placebo."
478553|NCT00413335|E1|Reported Event|Active Arm (Rosiglitazone)|"Subject undergoes ogtt, hyperinsulinemic-euglycemic clamp, abdominal and liver MRI, NMR and DEXA scan. Subject then receives Rosiglitazone. Subjects are followed every 2 weeks. Imaging repeated at 2 months. 12 week follow up. And then all tests are repeated at 4 months.~Rosiglitazone : 2mg to begin then 4mg, twice daily for 4 months"
478554|NCT00413283|B5|Baseline|Total|Total of all reporting groups
478555|NCT00413283|B4|Baseline|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478556|NCT00413283|B3|Baseline|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478557|NCT00413283|B2|Baseline|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478558|NCT00413283|B1|Baseline|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478559|NCT00413283|P4|Participant Flow|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478560|NCT00413283|P3|Participant Flow|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478561|NCT00413283|P2|Participant Flow|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478562|NCT00413283|P1|Participant Flow|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478563|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478564|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478565|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478566|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478567|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478628|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478629|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478568|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478569|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478570|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478571|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478572|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478573|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478574|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478575|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478576|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478577|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478578|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478579|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478580|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478581|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478582|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478630|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478631|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478583|NCT00413283|O4|Outcome|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478584|NCT00413283|O3|Outcome|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478585|NCT00413283|O2|Outcome|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478586|NCT00413283|O1|Outcome|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478587|NCT00413283|E4|Reported Event|Romiplostim 750 µg|Participants received romiplostim 750 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478588|NCT00413283|E3|Reported Event|Romiplostim 500 µg|Participants received romiplostim 500 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478589|NCT00413283|E2|Reported Event|Romiplostim 250 µg|Participants received romiplostim 250 μg administered subcutaneously on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478590|NCT00413283|E1|Reported Event|Placebo|Participants received a placebo subcutaneous injection on Day 2 of each chemotherapy cycle. Chemotherapy consisted of 21-day cycles of gemcitabine/carboplatin (gemcitabine and carboplatin on Day 1 and gemcitabine again on Day 8) or 21-day cycles of gemcitabine/cisplatin (gemcitabine and cisplatin on Day 1 and gemcitabine again on Day 8), up to a maximum of 5 cycles administered according to standard institutional practice.
478591|NCT00413244|B3|Baseline|Total|Total of all reporting groups
478592|NCT00413244|B2|Baseline|Placebo|Matching Placebo
478593|NCT00413244|B1|Baseline|Androgel|Androgel 5 grams
478594|NCT00413244|P2|Participant Flow|Placebo|Matching Placebo
478595|NCT00413244|P1|Participant Flow|Androgel|Androgel 5 grams
478596|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478597|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478598|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478599|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478600|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478601|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478602|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478603|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478604|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478605|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478606|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478607|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478608|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478609|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478610|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478611|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478612|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478613|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478614|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478615|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478616|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478617|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478618|NCT00413244|O2|Outcome|Placebo|Matching Placebo
478619|NCT00413244|O1|Outcome|Androgel|Androgel 5 grams
478620|NCT00413244|E2|Reported Event|Placebo|Matching Placebo
478621|NCT00413244|E1|Reported Event|Androgel|Androgel 5 grams
478622|NCT00413231|B1|Baseline|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478623|NCT00413231|P1|Participant Flow|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478624|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478625|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478626|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478627|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478726|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478632|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478633|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478634|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478635|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478636|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478637|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478638|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478639|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478640|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478641|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478642|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478643|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478644|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478645|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478646|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478647|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478648|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478649|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study.~Valiant Thoracic Stent Graft System: Surgical procedure in which a device is implanted inside the aorta, isolating the diseased area (aneurysm)."
478650|NCT00413231|O1|Outcome|Valiant Thoracic Stent Graft System|Subjects treated or intended to treat with the test device (Valiant Thoracic Stent Graft System).
478651|NCT00413231|E1|Reported Event|Valiant Thoracic Stent Graft System|"160 subjects were enrolled into the study, including 157 subjects treated with the study device and three subjects classified as intent-to-treat who did not receive the study device.~There were no other arms for this study."
478652|NCT00413153|B3|Baseline|Total|Total of all reporting groups
478653|NCT00413153|B2|Baseline|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478654|NCT00413153|B1|Baseline|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478655|NCT00413153|P2|Participant Flow|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478656|NCT00413153|P1|Participant Flow|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478657|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478658|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478659|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478660|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478661|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478662|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478663|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478664|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478665|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478666|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478667|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478668|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478669|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478670|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478671|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478672|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478673|NCT00413153|O2|Outcome|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478674|NCT00413153|O1|Outcome|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478675|NCT00413153|E2|Reported Event|Continue Kaletra (LPV/r)|Kaletra (pre-study dose)
478676|NCT00413153|E1|Reported Event|Boosted Reyataz (ATV/r)|Boosted Reyataz (300mg atazanavir + 100mg ritonavir)
478677|NCT00413062|B3|Baseline|Total|Total of all reporting groups
478678|NCT00413062|B2|Baseline|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478700|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478679|NCT00413062|B1|Baseline|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478680|NCT00413062|P2|Participant Flow|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478681|NCT00413062|P1|Participant Flow|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478682|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478683|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478684|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478685|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478686|NCT00413062|O2|Outcome|DRSP-EE|"Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
478687|NCT00413062|O1|Outcome|NOMAC-E2|"Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).~n= number of participants with evaluable cycles (except for the very last cycle of a participant for which this parameter was not defined)."
478688|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478689|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478690|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478691|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478692|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478693|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478694|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478695|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478696|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478697|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478698|NCT00413062|O2|Outcome|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478699|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478725|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478701|NCT00413062|O1|Outcome|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478702|NCT00413062|E2|Reported Event|DRSP-EE|Monophasic COC tablets containing 3 mg Drospirenone (DRSP) and 30 mcg Ethinyl Estradiol (EE) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-21, active tablets; Days 22-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478703|NCT00413062|E1|Reported Event|NOMAC-E2|Monophasic combined oral contraceptive (COC) tablets containing 2.5 mg Nomegestrol Acetate (NOMAC) and 1.5 mg Estradiol (E2) taken once daily from Day 1 of menstrual period up to and including Day 28 (Days 1-24, active tablets; Days 25-28, placebo tablets) for 13 consecutive 28-day menstrual cycles (1 year).
478704|NCT00413049|B3|Baseline|Total|Total of all reporting groups
478705|NCT00413049|B2|Baseline|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478706|NCT00413049|B1|Baseline|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478707|NCT00413049|P2|Participant Flow|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478708|NCT00413049|P1|Participant Flow|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478709|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478710|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478711|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478712|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478713|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478714|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478715|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478716|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478717|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478718|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478719|NCT00413049|O2|Outcome|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478720|NCT00413049|O1|Outcome|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478721|NCT00413049|E2|Reported Event|Amlodipine 5 mg|1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478722|NCT00413049|E1|Reported Event|Valsartan/Amlodipine 80/5 mg|1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.
478723|NCT00413036|B1|Baseline|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478724|NCT00413036|P1|Participant Flow|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478727|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478728|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478729|NCT00413036|O1|Outcome|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478730|NCT00413036|E1|Reported Event|Lenalidomide|25 mg oral lenalidomide once daily on Days 1-21 every 28 days
478731|NCT00413010|B3|Baseline|Total|Total of all reporting groups
478732|NCT00413010|B2|Baseline|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478733|NCT00413010|B1|Baseline|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478734|NCT00413010|P2|Participant Flow|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478735|NCT00413010|P1|Participant Flow|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478736|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478737|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478738|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478739|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478740|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478741|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478742|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478743|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478744|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478745|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478746|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478747|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478748|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478867|NCT00412867|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478990|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478749|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478750|NCT00413010|O2|Outcome|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478751|NCT00413010|O1|Outcome|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478752|NCT00413010|E2|Reported Event|Placebo|Placebo was administrated orally, twice daily (BID) with or without food, during the double-blind phase. Subjects were required to remain on a stable dose of their concurrent GAD treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478753|NCT00413010|E1|Reported Event|Pregabalin|Pregabalin doses of 150 milligrams (mg)/day, 300 mg/day, 450 mg/day, and 600 mg/day was administered orally, twice daily (BID), with or without food, during the double-blind phase. Flexible dosing of pregabalin was allowed during the first 6 weeks; fixed dosing was required for the last 2 weeks of this period.Subjects were required to remain on a stable dose of their concurrent Generalized Anxiety Disorder (GAD) treatment (ie, escitalopram, paroxetine, or venlafaxine XR).
478754|NCT00412984|B3|Baseline|Total|Total of all reporting groups
478755|NCT00412984|B2|Baseline|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478756|NCT00412984|B1|Baseline|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478757|NCT00412984|P2|Participant Flow|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478758|NCT00412984|P1|Participant Flow|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478759|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478760|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478761|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478762|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478763|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478764|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478765|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
482389|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
478766|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478767|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478768|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478769|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478770|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478771|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478772|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478773|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478774|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478775|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478776|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478777|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478778|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478779|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478780|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478845|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478781|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478782|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478783|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478784|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478785|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478786|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478787|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478788|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478789|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478790|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478791|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478792|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478793|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478794|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478795|NCT00412984|O2|Outcome|Warfarin|Participants received apixaban-placebo and warfarin following randomization during a titration phase using a dosing algorithm for warfarin; apixaban-placebo was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin doses were recommended based upon an algorithm and encrypted INR testing to preserve the double blind; however, the final dosing decision rested with the investigator.
478844|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478796|NCT00412984|O1|Outcome|Apixaban|Participants received apixaban and warfarin-placebo following randomization during a titration phase using a dosing algorithm for warfarin- placebo; apixaban was dosed at 5 mg twice daily (BID) [or 2.5 mg BID in select subjects]. Subsequent warfarin placebo doses were recommended based upon an algorithm using an encrypted, shammed International Normalized Ratio (INR) procedure to preserve the double blind; however, the final dosing decision rested with the investigator.
478797|NCT00412984|E2|Reported Event|Apixaban|
478798|NCT00412984|E1|Reported Event|Warfarin|
478799|NCT00412971|B3|Baseline|Total|Total of all reporting groups
478800|NCT00412971|B2|Baseline|White Light|Standard White light cystoscopy
478801|NCT00412971|B1|Baseline|Hexvix Cystoscopy Group|
478802|NCT00412971|P2|Participant Flow|White Light|Standard White light cystoscopy
478803|NCT00412971|P1|Participant Flow|Hexvix Cystoscopy Group|
478804|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
478805|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
478806|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
478807|NCT00412971|O2|Outcome|White Light|Standard White light cystoscopy
478808|NCT00412971|O1|Outcome|Hexvix Cystoscopy Group|
478809|NCT00412971|E2|Reported Event|White Light|Standard White light cystoscopy
478810|NCT00412971|E1|Reported Event|Hexvix Cystoscopy Group|
478811|NCT00412958|B5|Baseline|Total|Total of all reporting groups
478812|NCT00412958|B4|Baseline|Placebo|Intravitreal injection of placebo.
478813|NCT00412958|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
478814|NCT00412958|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
478815|NCT00412958|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection
478816|NCT00412958|P4|Participant Flow|Placebo|Intravitreal injection of placebo.
478817|NCT00412958|P3|Participant Flow|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
478818|NCT00412958|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
478819|NCT00412958|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
478820|NCT00412958|O4|Outcome|Placebo|Intravitreal injection of placebo.
478821|NCT00412958|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection.
478822|NCT00412958|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection.
478823|NCT00412958|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection.
478824|NCT00412958|E4|Reported Event|Placebo|Intravitreal injection of placebo.
478825|NCT00412958|E3|Reported Event|Ocriplasmin 125µg|125µg of ocriplasmin intravitreal injection.
478826|NCT00412958|E2|Reported Event|Ocriplasmin 75µg|75µg of ocriplasmin intravitreal injection.
478827|NCT00412958|E1|Reported Event|Ocriplasmin 25µg|25µg of ocriplasmin intravitreal injection.
478828|NCT00412932|B1|Baseline|Active Treatment Period|All participants started the active treatment period with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40 mg Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
478829|NCT00412932|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm 40 mg + HCTZ 25 mg if their blood pressure was not controlled.
478830|NCT00412932|O1|Outcome|Overall Study|
478831|NCT00412932|O1|Outcome|Overall Study|
478832|NCT00412932|O1|Outcome|Overall Study|
478833|NCT00412932|O1|Outcome|Overall Study|
478834|NCT00412932|O1|Outcome|Overall Study|
478835|NCT00412932|O1|Outcome|Overall Study|
478836|NCT00412932|O1|Outcome|Overall Study|
478837|NCT00412893|B3|Baseline|Total|Total of all reporting groups
478838|NCT00412893|B2|Baseline|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478839|NCT00412893|B1|Baseline|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478840|NCT00412893|P2|Participant Flow|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478841|NCT00412893|P1|Participant Flow|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478842|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478843|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478939|NCT00412750|E2|Reported Event|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478846|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478847|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478848|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478849|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478850|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478851|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478852|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478853|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478854|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478855|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478856|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478857|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478858|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478859|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478860|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478861|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478862|NCT00412893|O2|Outcome|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478863|NCT00412893|O1|Outcome|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478864|NCT00412893|E2|Reported Event|Voriconazole|Participants received a loading dose of voriconazole, 6 mg/kg every 12 hours IV for the first 24 hours, followed by a maintenance dose of 4 mg/kg every 12 hours by IV on Day 2. Beginning on Day 3, participants received 4 mg/kg every 12 hours by IV or 200 mg every 12 hours orally, until they reached a treatment endpoint or for a maximum of 84 days.
478865|NCT00412893|E1|Reported Event|Isavuconazole|Participants received a loading dose of isavuconazole, 200 mg three times a day by intravenous infusion (IV) for the first 2 days followed by a maintenance dose from Day 3 of 200 mg once daily either IV or orally until they reached a treatment endpoint or for a maximum of 84 days.
478866|NCT00412867|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478868|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478869|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478870|NCT00412867|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478871|NCT00412867|E2|Reported Event|Alteplase (Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478872|NCT00412867|E1|Reported Event|Alteplase (Non-Haemorrhage)|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
478873|NCT00412854|B3|Baseline|Total|Total of all reporting groups
478874|NCT00412854|B2|Baseline|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478875|NCT00412854|B1|Baseline|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478876|NCT00412854|P2|Participant Flow|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478877|NCT00412854|P1|Participant Flow|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478878|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478879|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478880|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478881|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478882|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478883|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478884|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478885|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478886|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478887|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478888|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478889|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478890|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478891|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478892|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478893|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478894|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478895|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478896|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478897|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478898|NCT00412854|O2|Outcome|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478899|NCT00412854|O1|Outcome|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478900|NCT00412854|E2|Reported Event|Infanrix+Hiberix Group|Healthy male and female infants who received Infanrix™ and Hiberix™ vaccines as a three-dose primary vaccination course at 3, 4 and 5 months of age, co-administered as separate intramuscular injections, into the left and right anterolateral thighs, respectively.
478901|NCT00412854|E1|Reported Event|Infanrix/Hib Group|Healthy male and female infants who received Infanrix™/Hib vaccine as a three-dose primary vaccination course at 3, 4 and 5 months of age, administered as an intramuscular injection, into the left anterolateral thigh.
478902|NCT00412841|B3|Baseline|Total|Total of all reporting groups
478903|NCT00412841|B2|Baseline|Placebo|
478904|NCT00412841|B1|Baseline|Atorvastatin|Atorvastatin 40mg
478905|NCT00412841|P2|Participant Flow|Placebo|
478906|NCT00412841|P1|Participant Flow|Atorvastatin|40 mg
478907|NCT00412841|O2|Outcome|Placebo|
478908|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
478909|NCT00412841|O2|Outcome|Placebo|
478910|NCT00412841|O1|Outcome|Atorvastatin|Atorvastatin 40mg
478911|NCT00412841|E2|Reported Event|Placebo|Placebo
478912|NCT00412841|E1|Reported Event|Atorvastatin|Atorvastatin 40mg
478913|NCT00412750|B4|Baseline|Total|Total of all reporting groups
478914|NCT00412750|B3|Baseline|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478915|NCT00412750|B2|Baseline|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478916|NCT00412750|B1|Baseline|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478917|NCT00412750|P3|Participant Flow|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478918|NCT00412750|P2|Participant Flow|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478919|NCT00412750|P1|Participant Flow|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478920|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478921|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478922|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478923|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478924|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478925|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478926|NCT00412750|O1|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478927|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478928|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478929|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478930|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478931|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478932|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478933|NCT00412750|O3|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478934|NCT00412750|O2|Outcome|LdT Monotherapy|Telbivudine (LdT) monotherapy: 600 mg orally once daily for 104 weeks.
478935|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478936|NCT00412750|O2|Outcome|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478937|NCT00412750|O1|Outcome|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478938|NCT00412750|E3|Reported Event|PEG-INF Monotherapy|Peg interferon (PEG- INF) alpha-2a monotherapy: 180 μg subcutaneous injection once a week for 52 weeks.
478940|NCT00412750|E1|Reported Event|LdT + PEG-INF|Telbivudine (LdT) 600 mg orally once a day for 104 weeks in combination with peg interferon (PEG-INF) alpha-2a 180 μg subcutaneous injection once a week for 52 weeks.
478941|NCT00412737|B3|Baseline|Total|Total of all reporting groups
478942|NCT00412737|B2|Baseline|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478943|NCT00412737|B1|Baseline|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478944|NCT00412737|P2|Participant Flow|Oseltamivir|Oseltamivir 30 milligram (mg) to 75 mg capsule or suspension orally once daily for 12 weeks.
478945|NCT00412737|P1|Participant Flow|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478946|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478947|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478948|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478949|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478950|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478951|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478952|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478953|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478954|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478955|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478956|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478957|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478958|NCT00412737|O2|Outcome|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478959|NCT00412737|O1|Outcome|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478960|NCT00412737|E2|Reported Event|Oseltamivir|Oseltamivir 30 mg to 75 mg capsule or suspension orally once daily for 12 weeks.
478961|NCT00412737|E1|Reported Event|Placebo|Placebo matched to oseltamivir capsule or suspension orally once daily for 12 weeks.
478962|NCT00412607|B1|Baseline|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478963|NCT00412607|P1|Participant Flow|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478964|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478965|NCT00412607|O3|Outcome|Reported No Recurrence|Subjects reported no recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
478966|NCT00412607|O2|Outcome|Reported Recurrence|Subjects reported recurrence of Ventricular Tachycardia (VT) at 12-month, 3-year follow-up visit
478967|NCT00412607|O1|Outcome|Total|Total number of subjects who completed 12-month, 2-year, and 3-year follow-up respectively.
478968|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478969|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478970|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478971|NCT00412607|O1|Outcome|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478972|NCT00412607|E1|Reported Event|NAVISTAR THERMOCOOL Catheter|NaviStar ThermoCool Deflectable Diagnostic/Ablation Catheter for the Treatment of Ventricular Tachycardia.
478973|NCT00412542|B3|Baseline|Total|Total of all reporting groups
478974|NCT00412542|B2|Baseline|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
478975|NCT00412542|B1|Baseline|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
478976|NCT00412542|P2|Participant Flow|Anaplastic Gliomas: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
478977|NCT00412542|P1|Participant Flow|Glioblastoma Multiforme: Thalidomide + CPT-11|Oral Thalidomide 100 mg daily for 8 weeks + CPT-11 125 mg/m^2 by vein weekly over 90 minutes for 4 weeks, followed by 2 weeks rest.
478978|NCT00412542|O1|Outcome|Participants With Recurrent Malignant Gliomas|The endpoints combined results of all strata (Arm 1 of Glioblastoma Multiforme: Thalidomide + CPT-11 and Arm 2 of Anaplastic Gliomas: Thalidomide + CPT-11).
478979|NCT00412542|E1|Reported Event|Patients With Recurrent Malignant Gliomas|The endpoints combined results of all strata
478980|NCT00412529|B3|Baseline|Total|Total of all reporting groups
478981|NCT00412529|B2|Baseline|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478982|NCT00412529|B1|Baseline|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478983|NCT00412529|P2|Participant Flow|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478984|NCT00412529|P1|Participant Flow|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478985|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478986|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478987|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478988|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478989|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478991|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478992|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478993|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478994|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478995|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478996|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478997|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
478998|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
478999|NCT00412529|O2|Outcome|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
479000|NCT00412529|O1|Outcome|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
479001|NCT00412529|E2|Reported Event|Entecavir|Entecavir 0.5 mg once daily for 12 weeks.
479002|NCT00412529|E1|Reported Event|Telbivudine|Telbivudine 600 mg once daily for 12 weeks.
479003|NCT00412516|B4|Baseline|Total|Total of all reporting groups
479004|NCT00412516|B3|Baseline|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479005|NCT00412516|B2|Baseline|Group 2|Measles and SA 14-14-2 given concurrently
479006|NCT00412516|B1|Baseline|Group 1|SA 14-14-2 followed by measles vaccine one month later
479007|NCT00412516|P3|Participant Flow|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479008|NCT00412516|P2|Participant Flow|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479009|NCT00412516|P1|Participant Flow|Group 1|SA 14-14-2 followed by measles vaccine one month later
479010|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479011|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479012|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
479013|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479014|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479015|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
479016|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479017|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479018|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
479019|NCT00412516|O3|Outcome|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479020|NCT00412516|O2|Outcome|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479021|NCT00412516|O1|Outcome|Group 1|SA 14-14-2 followed by measles vaccine one month later
479022|NCT00412516|E3|Reported Event|Group 3|Measles vaccine followed by SA 14-14-2 one month later
479023|NCT00412516|E2|Reported Event|Group 2|"Measles and SA 14-14-2 given concurrently~Live attenuated SA 14-14-2 vaccine: Live attenuated SA 14-14-2 vaccine coadministered with live measles vaccine (experimental Group)"
479024|NCT00412516|E1|Reported Event|Group 1|SA 14-14-2 followed by measles vaccine one month later
479025|NCT00412464|B1|Baseline|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479026|NCT00412464|P1|Participant Flow|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479027|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479028|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479029|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479030|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479031|NCT00412464|O1|Outcome|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479032|NCT00412464|E1|Reported Event|Fondaparinux Group|Single arm group receiving fondaparinux 0.1 mg/kg.
479033|NCT00412451|B5|Baseline|Total|Total of all reporting groups
479034|NCT00412451|B4|Baseline|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
479035|NCT00412451|B3|Baseline|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
479036|NCT00412451|B2|Baseline|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
479037|NCT00412451|B1|Baseline|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
479038|NCT00412451|P4|Participant Flow|Sham Injection|Sham intravitreal injection
479039|NCT00412451|P3|Participant Flow|0criplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
479040|NCT00412451|P2|Participant Flow|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
479041|NCT00412451|P1|Participant Flow|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injections versus sham injection
479042|NCT00412451|O4|Outcome|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
479043|NCT00412451|O3|Outcome|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
479044|NCT00412451|O2|Outcome|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
479045|NCT00412451|O1|Outcome|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
479046|NCT00412451|E4|Reported Event|Sham Injection|"Sham injection~Sham injection : Sham intravitreal injection"
479047|NCT00412451|E3|Reported Event|Ocriplasmin 125µg|125µg ocriplasmin intravitreal injection versus sham injection
479048|NCT00412451|E2|Reported Event|Ocriplasmin 75µg|75µg ocriplasmin intravitreal injection versus sham injection
482390|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
479049|NCT00412451|E1|Reported Event|Ocriplasmin 25µg|25µg ocriplasmin intravitreal injection versus sham injection
479050|NCT00412425|B3|Baseline|Total|Total of all reporting groups
479051|NCT00412425|B2|Baseline|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
479052|NCT00412425|B1|Baseline|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
479053|NCT00412425|P2|Participant Flow|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
479054|NCT00412425|P1|Participant Flow|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
479055|NCT00412425|O2|Outcome|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
479056|NCT00412425|O1|Outcome|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
479057|NCT00412425|E2|Reported Event|2 Days Palonosetron|2 Days Palonosetron 0.25 mg IV
479058|NCT00412425|E1|Reported Event|3 Days Palonosetron|3 Days Palonosetron 0.25 mg intravenous (IV)
479059|NCT00412373|B3|Baseline|Total|Total of all reporting groups
479060|NCT00412373|B2|Baseline|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479061|NCT00412373|B1|Baseline|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479062|NCT00412373|P2|Participant Flow|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479063|NCT00412373|P1|Participant Flow|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479064|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479065|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479066|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479067|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479068|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479069|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479070|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479071|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479072|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479073|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479074|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479075|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
480315|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
479076|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479077|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479078|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479079|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479080|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479081|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479082|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479083|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479084|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479085|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479086|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479087|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479088|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479089|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479090|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479091|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479092|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479093|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479132|NCT00412243|E1|Reported Event|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
479133|NCT00412217|B3|Baseline|Total|Total of all reporting groups
479266|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
479094|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479095|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479096|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479097|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479098|NCT00412373|O2|Outcome|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479099|NCT00412373|O1|Outcome|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479100|NCT00412373|E2|Reported Event|Paliperidone Extended-Release (ER)|Paliperidone (9-hydroxy-risperidone, R076477) is an atypical antipsychotic agent approved for the treatment of schizophrenia and is in development for the treatment of bipolar disorder and schizoaffective disorder. Paliperidone is a monoaminergic antagonist that exhibits the characteristic dopamine type 2 (D2) and serotonin (5-hydroxytryptamine [5-HT]) type 2A (5HT2A) antagonism of the newer, or second-generation, antipsychotic drugs. Paliperidone is available in an oral formulation using extended-release (ER).
479101|NCT00412373|E1|Reported Event|Placebo|A placebo control was used to establish the frequency and magnitude of changes in clinical endpoints that could occur in the absence of active treatment.
479102|NCT00412360|B3|Baseline|Total|Total of all reporting groups
479103|NCT00412360|B2|Baseline|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479104|NCT00412360|B1|Baseline|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479105|NCT00412360|P2|Participant Flow|Double UCB Transplant|Double Cord Blood Unit Transplantation: Unrelated donor, double cord blood unit
479106|NCT00412360|P1|Participant Flow|Single UCB Transplant|Single Cord Blood Unit Transplantation: Unrelated donor, single cord blood unit
479107|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479108|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479109|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479110|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479111|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479112|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479113|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479114|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479115|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479116|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479117|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479118|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479119|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479120|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479121|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479122|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479123|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479124|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479125|NCT00412360|O2|Outcome|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479126|NCT00412360|O1|Outcome|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479127|NCT00412360|E2|Reported Event|Double UCB Transplant|Double Umbilical Cord Blood Unit Transplantation
479128|NCT00412360|E1|Reported Event|Single UCB Transplant|Single Umbilical Cord Blood Unit Transplantation
479129|NCT00412243|B1|Baseline|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
479130|NCT00412243|P1|Participant Flow|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
479131|NCT00412243|O1|Outcome|Clofarabine + Cyclophosphamide|"Clofarabine 40 mg/m^2 daily for 3 Days + Cyclophosphamide starting 200 mg/m^2 every 12 hours for 3 days~Clofarabine : 40 mg/m^2 Daily for 3 Days~Cyclophosphamide : Beginning dose 200 mg/m^2 every 12 hours for 3 days"
479197|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479134|NCT00412217|B2|Baseline|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479135|NCT00412217|B1|Baseline|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479136|NCT00412217|P2|Participant Flow|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479137|NCT00412217|P1|Participant Flow|Erlotinib|Participants with histologically confirmed advanced squamous cell carcinoma (SCC) of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 milligrams (mg) once daily for 1 year until disease progression or intolerable toxicity.
479138|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479139|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479140|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479141|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479142|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479143|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479144|NCT00412217|O2|Outcome|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479145|NCT00412217|O1|Outcome|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479146|NCT00412217|E2|Reported Event|Placebo|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received placebo tablets (matched to erlotinib) once daily for 1 year until disease progression or intolerable toxicity.
479147|NCT00412217|E1|Reported Event|Erlotinib|Participants with histologically confirmed advanced SCC of the head and neck, treated with surgical resection and chemoradiotherapy or radiotherapy alone, received erlotinib tablets as 150 mg once daily for 1 year until disease progression or intolerable toxicity.
479148|NCT00412113|B3|Baseline|Total|Total of all reporting groups
479149|NCT00412113|B2|Baseline|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479150|NCT00412113|B1|Baseline|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479151|NCT00412113|P2|Participant Flow|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479152|NCT00412113|P1|Participant Flow|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479153|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479154|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479155|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479156|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479157|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479158|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479159|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479160|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479161|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479265|NCT00411762|O1|Outcome|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
479162|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479163|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479164|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479165|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479166|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479167|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479168|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479169|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479170|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479171|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479172|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479173|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479174|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479175|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479176|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479177|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479178|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479179|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479180|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479181|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479182|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479183|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479184|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479185|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479186|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479187|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479188|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479189|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479190|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479191|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479192|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479193|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479194|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479195|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479196|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479478|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479198|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479199|NCT00412113|O2|Outcome|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479200|NCT00412113|O1|Outcome|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479201|NCT00412113|E2|Reported Event|Caduet + TLC|Blinded Caduet (amlodipine besylate/atorvastatin calcium) 5/20 to 10/20 mg and matching Norvasc placebo dosed once daily along with TLC for 6 weeks.
479202|NCT00412113|E1|Reported Event|Norvasc + TLC|Blinded Norvasc (amlodipine) 5 to 10 milligram (mg) and matching Caduet placebo dosed once daily along with Therapeutic Lifestyle Changes (TLC) for 6 weeks.
479203|NCT00412087|B3|Baseline|Total|Total of all reporting groups
479204|NCT00412087|B2|Baseline|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479205|NCT00412087|B1|Baseline|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479206|NCT00412087|P2|Participant Flow|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479207|NCT00412087|P1|Participant Flow|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479208|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479209|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479210|NCT00412087|O2|Outcome|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479211|NCT00412087|O1|Outcome|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479212|NCT00412087|E2|Reported Event|Cholecalciferol 4000 IU|"Women are randomized to one of 2 treatment groups: 2000 or 4000 IU vitamin D3/day~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479213|NCT00412087|E1|Reported Event|Cholecalciferol 2000 IU|"Women at 12-16 weeks' gestation are enrolled into the study to receive 2000 IU/day vitamin D3 for one month. After the run-in dose, the subjects are randomized to one of two treatment groups: either 2000 or 4000 IU/day to be taken throughout pregnancy until delivery.~cholecalciferol (vitamin D3): randomized to one of two treatments: 2000 or 4000 IU vitamin D3/day~cholecalciferol: randomized to one of 2 treatment doses: 2000 vs. 4000 IU/day vitamin D3~cholecalciferol: cholecalciferol at 2000 or 4000 IU/day to be taken througout pregnancy. This follows the initial run-in dosing of 2000 IU/day starting at 12-weeks' gestation."
479214|NCT00412074|B4|Baseline|Total|Total of all reporting groups
479215|NCT00412074|B3|Baseline|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
480316|NCT00409344|O1|Outcome|Saline|This group will recive saline
479216|NCT00412074|B2|Baseline|2400 Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479217|NCT00412074|B1|Baseline|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
479218|NCT00412074|P3|Participant Flow|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479219|NCT00412074|P2|Participant Flow|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479220|NCT00412074|P1|Participant Flow|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
479221|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
479222|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
479223|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
479224|NCT00412074|O3|Outcome|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~6400 IU Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
479225|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~2400 IU Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating mother and 0 IU vitamin D3/day (placebo) given as oral supplement to her infant"
479226|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~400 IU Vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given as oral supplement to her infant"
479227|NCT00412074|O3|Outcome|6400 Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479228|NCT00412074|O2|Outcome|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479229|NCT00412074|O1|Outcome|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
479230|NCT00412074|E3|Reported Event|6400 IU Vitamin D3 (Cholecalciferol)|"6400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 6000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 6400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479231|NCT00412074|E2|Reported Event|2400 IU Vitamin D3 (Cholecalciferol)|"2400 IU vitamin D3 given to lactating mother: 400 IU vitamin D3 from a prenatal vitamin and 2000 IU vitamin D3 and 0 IU vitamin D3 (placebo) given to her breastfeeding infant~Vitamin D3 (cholecalciferol): 2400 IU vitamin D3/day given to lactating women and 0 IU vitamin D3/day (placebo) given as oral supplement to her breastfeeding infant"
479232|NCT00412074|E1|Reported Event|Control 400 IU Vitamin D3|"400 IU vitamin D3/day given to lactating women and 400 IU vitamin D3/day given as oral supplement to infant in dyad~vitamin D3 (cholecalciferol): 400 IU vitamin D3/day given to lactating mother and 400 IU vitamin D3/day given to her infant"
479233|NCT00412061|B3|Baseline|Total|Total of all reporting groups
479234|NCT00412061|B2|Baseline|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479235|NCT00412061|B1|Baseline|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
480317|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
479236|NCT00412061|P2|Participant Flow|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
479237|NCT00412061|P1|Participant Flow|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479238|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479239|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479240|NCT00412061|O1|Outcome|Everolimus Open Label Arm|Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
479241|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479242|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479243|NCT00412061|O2|Outcome|Octreotide+ Placebo Followed by Open Label Arm|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1. Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
479244|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479245|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479246|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479247|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479248|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479249|NCT00412061|O2|Outcome|Octreotide+ Placebo|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479250|NCT00412061|O1|Outcome|Octreotide+ Everolimus|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479251|NCT00412061|E3|Reported Event|Everolimus Open Label|Open Label - Patients who had progressive disease in this arm, can move to the open label Everolimus + depot octreotide by choice.
479252|NCT00412061|E2|Reported Event|Placebo + Octreotide|Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
479253|NCT00412061|E1|Reported Event|Everolimus + Octreotide|Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1.
479254|NCT00411788|B1|Baseline|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479255|NCT00411788|P1|Participant Flow|Rapamycin and Trastuzumab|Patients received oral rapamycin/sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479256|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479257|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479258|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479259|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479260|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479261|NCT00411788|O1|Outcome|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479262|NCT00411788|E1|Reported Event|Sirolimus and Trastuzumab|Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
479263|NCT00411762|B1|Baseline|PHY906 Administration|PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
479264|NCT00411762|P1|Participant Flow|PHY906 Administration|"PHY906 800mg, orally, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle~Capecitabine~PHY906"
482391|NCT00402987|O4|Outcome|Placebo|
479267|NCT00411762|E1|Reported Event|PHY906 Administration|PHY906 800mg, twice a day for days 1-4 and capecitabine 1500mg/m^2 days 1-7 of a 14-day cycle
479268|NCT00411749|B3|Baseline|Total|Total of all reporting groups
479269|NCT00411749|B2|Baseline|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479270|NCT00411749|B1|Baseline|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479271|NCT00411749|P2|Participant Flow|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479272|NCT00411749|P1|Participant Flow|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479273|NCT00411749|O4|Outcome|V501-HPV 18|HPV 18 serum antibody titer measured in V501 vaccination group
479274|NCT00411749|O3|Outcome|V501-HPV 16|HPV 16 serum antibody titer measured in V501 vaccination group
479275|NCT00411749|O2|Outcome|V501-HPV 11|HPV 11 serum antibody titer measured in V501 vaccination group
479276|NCT00411749|O1|Outcome|V501-HPV 6|HPV 6 serum antibody titer measured in V501 vaccination group
479277|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479278|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479279|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479280|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479281|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479282|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479283|NCT00411749|O2|Outcome|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479284|NCT00411749|O1|Outcome|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479285|NCT00411749|E2|Reported Event|Placebo|Placebo vaccination 0.5 ml injection in 3 dosing regimen.
479286|NCT00411749|E1|Reported Event|V501|V501 vaccination: Gardasil, 0.5 ml injection in 3 dosing regimen. Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (V501)
479287|NCT00411671|B1|Baseline|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479288|NCT00411671|P1|Participant Flow|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479289|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479290|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479291|NCT00411671|O1|Outcome|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479292|NCT00411671|E1|Reported Event|Sorafenib 400 mg|Sorafenib 400 mg by mouth twice daily in continuous 28 day cycles.
479293|NCT00411645|B3|Baseline|Total|Total of all reporting groups
479294|NCT00411645|B2|Baseline|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479295|NCT00411645|B1|Baseline|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479296|NCT00411645|P2|Participant Flow|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479297|NCT00411645|P1|Participant Flow|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479298|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479299|NCT00411645|O1|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479300|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479301|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479302|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479303|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479304|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479305|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479306|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479307|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479308|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479309|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479310|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479311|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479312|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479313|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479314|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479315|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479316|NCT00411645|O2|Outcome|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479317|NCT00411645|O1|Outcome|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479318|NCT00411645|E2|Reported Event|Maribavir 100 mg BID|Participants received maribavir 100 mg twice daily (BID) for up to 12 weeks.
479319|NCT00411645|E1|Reported Event|Placebo|Participants received placebo twice daily (BID) for up to 12 weeks.
479320|NCT00411619|B1|Baseline|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
479321|NCT00411619|P1|Participant Flow|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
479322|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
479323|NCT00411619|O1|Outcome|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus. The initial starting dose was to be 3.0 mg/m2/day taken either daily or every other day with titration to achieve target trough concentrations of 5 to 15 ng/mL, subject to tolerability. Study drug was self-administered orally (or administered by a caregiver) at the same time each day.
479324|NCT00411619|E1|Reported Event|Everolimus|This was a non-randomized, open-label, single arm study; all patients in the study received treatment with everolimus.
479325|NCT00411554|B3|Baseline|Total|Total of all reporting groups
479326|NCT00411554|B2|Baseline|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479327|NCT00411554|B1|Baseline|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479328|NCT00411554|P2|Participant Flow|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479329|NCT00411554|P1|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479330|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479331|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479332|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479333|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479334|NCT00411554|O2|Outcome|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479335|NCT00411554|O1|Outcome|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479336|NCT00411554|E2|Reported Event|Voglibose 0.2 mg TID|The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
479337|NCT00411554|E1|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
479338|NCT00411450|B1|Baseline|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479339|NCT00411450|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479340|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479341|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479342|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479343|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479344|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479345|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479346|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479347|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479348|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479349|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479350|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479351|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479352|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479353|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479354|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479355|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479356|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479357|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479358|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479359|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479360|NCT00411450|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479361|NCT00411450|O2|Outcome|Mutant KRAS|Participants with mutant KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479362|NCT00411450|O1|Outcome|Wild-type KRAS|Participants with wild-type KRAS received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin.
479363|NCT00411450|E1|Reported Event|Panitumumab + FOLFIRI|Participants received 6 mg/kg panitumumab intravenously (IV) once every 14 days in combination with FOLFIRI chemotherapy regimen consisting of irinotecan, infusional 5-fluorouracil, and leucovorin, until disease progression, intolerability, death, or study withdrawal.
479364|NCT00411411|B3|Baseline|Total|Total of all reporting groups
479365|NCT00411411|B2|Baseline|Januvia|Active treatment
479366|NCT00411411|B1|Baseline|Placebo|Placebo treatment
479367|NCT00411411|P2|Participant Flow|Januvia|Active treatment
479368|NCT00411411|P1|Participant Flow|Placebo|Placebo treatment
479369|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
479370|NCT00411411|O1|Outcome|Placebo|"Placebo treatment, administered as tablets.~Placebo: Placebo"
479371|NCT00411411|O2|Outcome|Januvia|"Active treatment~Januvia: 200 mg t.i.d"
479372|NCT00411411|O1|Outcome|Placebo|Placebo: Placebo
479373|NCT00411411|E2|Reported Event|Januvia|Active treatment. No adverse events recorded
479374|NCT00411411|E1|Reported Event|Placebo|No adverse events recorded
479375|NCT00411398|B1|Baseline|Memantine|Memantine tablets
479376|NCT00411398|P1|Participant Flow|Memantine|Memantine tablets
479377|NCT00411398|O1|Outcome|Memantine|Memantine tablets
479378|NCT00411398|E1|Reported Event|Memantine|Memantine tablets
479379|NCT00411216|B3|Baseline|Total|Total of all reporting groups
479380|NCT00411216|B2|Baseline|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
479381|NCT00411216|B1|Baseline|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
479382|NCT00411216|P2|Participant Flow|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
479383|NCT00411216|P1|Participant Flow|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
479384|NCT00411216|O2|Outcome|Control Exercises|"Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements~Control exercises: saccadic eye movements against a plain background; no head movements"
479385|NCT00411216|O1|Outcome|Exercises for Gaze Stabilization|"Experimental group performed vestibular adaptation and substitution exercises~gaze stabilization exercises: adaptation and substitutin exercises encorporating retinal lsip and head movements"
479386|NCT00411216|E2|Reported Event|Control Exercises|Saccadic eye movements against a Ganzfeld to prevent retinal slip error signal; no head movements
479387|NCT00411216|E1|Reported Event|Exercises for Gaze Stabilization|Experimental group performed gaze stabilization exercises: adaptation and substitution exercises encorporating retinal slip and head movements
479388|NCT00411151|B1|Baseline|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479389|NCT00411151|P1|Participant Flow|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479390|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479391|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479392|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479393|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479394|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479395|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479396|NCT00411151|O1|Outcome|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479397|NCT00411151|E1|Reported Event|Sunitinib|"open-label and uncontrolled treatment cycle 4+2: Sunitinib capsules for oral administration (50mg daily for 4 weeks and 2 weeks rest)"
479398|NCT00410904|B3|Baseline|Total|Total of all reporting groups
479399|NCT00410904|B2|Baseline|Arm I Cohort B - Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479400|NCT00410904|B1|Baseline|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479401|NCT00410904|P2|Participant Flow|Arm I Cohort B- Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479402|NCT00410904|P1|Participant Flow|Arm I Cohort A- No Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479403|NCT00410904|O2|Outcome|Arm I - Cohort B, Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479404|NCT00410904|O1|Outcome|Arm I - Cohort A, no Prior Bevacizumab (Avastin)|Patients receive oral AZD2171 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.
479405|NCT00410904|E2|Reported Event|Arm I - Cohort B|"This is a one arm study with two cohorts.~Cohort B: Prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
479406|NCT00410904|E1|Reported Event|Arm I - Cohort A|"This is a one arm study with two cohorts.~Cohort A: No prior bevacizumab before entering into this trial~Patients receive AZD2171, 30 mg orally once daily on days 1-28 in course 1 and on days 1-21 in course 2 and all subsequent courses. Patients also receive pemetrexed disodium 500mg/m2 in 100 ml of 0.9% sodium chloride, IV over 10 minutes on day 8 in course 1 and on day 1 in course 2 and all subsequent courses. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
479407|NCT00410891|B1|Baseline|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
479408|NCT00410891|P1|Participant Flow|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
479409|NCT00410891|O1|Outcome|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
479410|NCT00410891|E1|Reported Event|Topical Antibiotic|"topical gatifloxacin 4 times per day~gatifloxacin"
479411|NCT00410826|B3|Baseline|Total|Total of all reporting groups
479412|NCT00410826|B2|Baseline|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
479413|NCT00410826|B1|Baseline|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
479414|NCT00410826|P2|Participant Flow|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
479415|NCT00410826|P1|Participant Flow|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
479416|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
479417|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
479418|NCT00410826|O2|Outcome|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO daily on days -7 to 47.
479419|NCT00410826|O1|Outcome|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
479420|NCT00410826|E2|Reported Event|Arm B (Cisplatin, Radiotherapy, Erlotinib)|Patients receive cisplatin and radiotherapy as in Arm A. Patients also receive erlotinib hydrochloride PO QD on days -7 to 47.
479421|NCT00410826|E1|Reported Event|Arm A (Cisplatin and Radiotherapy)|Patients receive cisplatin IV on days 1, 22, and 43 and undergo 3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on days 1-47.
479422|NCT00410761|B3|Baseline|Total|Total of all reporting groups
479423|NCT00410761|B2|Baseline|Placebo|Placebo daily
479424|NCT00410761|B1|Baseline|Vandetanib 300 mg|Vandetanib (300 mg daily)
479425|NCT00410761|P2|Participant Flow|Placebo|Placebo daily
479426|NCT00410761|P1|Participant Flow|Vandetanib 300 mg|Vandetanib (300 mg daily)
479427|NCT00410761|O2|Outcome|Placebo|Placebo daily
479428|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479429|NCT00410761|O2|Outcome|Placebo|Placebo daily
479430|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479431|NCT00410761|O2|Outcome|Placebo|Placebo daily
479432|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479433|NCT00410761|O2|Outcome|Placebo|Placebo daily
479434|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479435|NCT00410761|O2|Outcome|Placebo|Placebo daily
479436|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479437|NCT00410761|O2|Outcome|Placebo|Placebo daily
479438|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479439|NCT00410761|O2|Outcome|Placebo|Placebo daily
479440|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479441|NCT00410761|O2|Outcome|Placebo|Placebo daily
479442|NCT00410761|O1|Outcome|Vandetanib 300 mg|Vandetanib (300 mg daily)
479443|NCT00410761|E2|Reported Event|Placebo|Placebo daily
479444|NCT00410761|E1|Reported Event|Vandetanib 300 mg|Vandetanib (300 mg daily)
479445|NCT00410514|B4|Baseline|Total|Total of all reporting groups
479446|NCT00410514|B3|Baseline|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479447|NCT00410514|B2|Baseline|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479448|NCT00410514|B1|Baseline|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479449|NCT00410514|P3|Participant Flow|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479450|NCT00410514|P2|Participant Flow|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479451|NCT00410514|P1|Participant Flow|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479452|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479453|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479454|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479455|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479456|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479457|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479458|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479459|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479460|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479461|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479462|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479463|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479464|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479465|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479466|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479467|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479468|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479469|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479470|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479471|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479472|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479473|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479474|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479475|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479476|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479477|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
480318|NCT00409344|O1|Outcome|Saline|This group will recive saline
479479|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479480|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479481|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479482|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479483|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479484|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479485|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479486|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479487|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479488|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479489|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479490|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479491|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479492|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479493|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479494|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479495|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479496|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479497|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479498|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479499|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479500|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479501|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479502|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479503|NCT00410514|O3|Outcome|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479504|NCT00410514|O2|Outcome|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479505|NCT00410514|O1|Outcome|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479506|NCT00410514|E3|Reported Event|Mirabegron 100 mg|Participants received 100 mg mirabegron tablets orally once daily for 12 weeks.
479507|NCT00410514|E2|Reported Event|Mirabegron 50 mg|Participants received 50 mg mirabegron tablets orally once daily for 12 weeks.
479508|NCT00410514|E1|Reported Event|Placebo|Participants received matching mirabegron placebo tablets orally once daily for 12 weeks.
479509|NCT00410488|B3|Baseline|Total|Total of all reporting groups
479510|NCT00410488|B2|Baseline|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479511|NCT00410488|B1|Baseline|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479512|NCT00410488|P2|Participant Flow|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479513|NCT00410488|P1|Participant Flow|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479543|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479514|NCT00410488|O2|Outcome|Palonosetron - 3 Doses|"Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479515|NCT00410488|O1|Outcome|Palonosetron - 1 Dose|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479516|NCT00410488|E1|Reported Event|Palonosetron|"Arm 1: Palonosetron 0.25 mg intravenous (IV) for 1 dose (day 0) and Arm 2: Palonosetron 0.25 mg IV for 3 doses (days 0, 2, 4).~Dexamethasone: IV piggyback daily for 5 days (12 mg on day 0, and 8 mg on days 1-4) 30 minutes prior to chemotherapy. Chemotherapy treatment regimen: Zinecard: 750 mg/m2 as an IV bolus; Doxorubicin: 75 mg/m2 as an IV bolus OR 75 mg/m2 as continuous IV infusion over 72 hours (without zinecard) on Day 0. Mesna: 500 mg/m2 given simultaneously with ifosfamide day 0; then 1500 mg/m2 over 24 hours for days 0, 1, 2, and 3 (infusion completing on day 4); Ifosfamide: 2.5 g/m2 IV bolus over 3 hours; days 0, 1, 2, 3 (total dose = 10 g/m2); Vincristine: 2 mg IV by rapid administration on day 0 (for patients with small cell histology)."
479517|NCT00410410|B7|Baseline|Total|Total of all reporting groups
479518|NCT00410410|B6|Baseline|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479519|NCT00410410|B5|Baseline|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479520|NCT00410410|B4|Baseline|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479521|NCT00410410|B3|Baseline|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479522|NCT00410410|B2|Baseline|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479523|NCT00410410|B1|Baseline|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479524|NCT00410410|P9|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479525|NCT00410410|P8|Participant Flow|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479526|NCT00410410|P7|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479527|NCT00410410|P6|Participant Flow|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479528|NCT00410410|P5|Participant Flow|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479529|NCT00410410|P4|Participant Flow|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479530|NCT00410410|P3|Participant Flow|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479531|NCT00410410|P2|Participant Flow|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479532|NCT00410410|P1|Participant Flow|Induction Period Cohort 1 (IP1C)-Abatacept (ABA) 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479533|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479534|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479535|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479536|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479537|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479538|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479539|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479540|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479541|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479542|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479544|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479545|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479546|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479547|NCT00410410|O2|Outcome|ABA ~10 mg/kg, MP|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479548|NCT00410410|O1|Outcome|ABA 30/~10 mg/kg, MP|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479549|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479550|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479551|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479552|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479553|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479554|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479555|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479556|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479557|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479558|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479559|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479560|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479561|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479562|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479563|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479564|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479565|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479566|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479567|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479568|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479569|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479570|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479571|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479572|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479573|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479574|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479575|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479576|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479577|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479578|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479579|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479580|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479581|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479582|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479583|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479584|NCT00410410|O2|Outcome|IP1C+IP2C: ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479585|NCT00410410|O1|Outcome|IP1C+IP2C: ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479586|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479587|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479588|NCT00410410|O2|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479589|NCT00410410|O1|Outcome|IP2C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479590|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479591|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479592|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479593|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479594|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479595|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479596|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479597|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479598|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479599|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479600|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479601|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479602|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479603|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479604|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479605|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479606|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479607|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479608|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479609|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479610|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479611|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479612|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479613|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479614|NCT00410410|O6|Outcome|IP2C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479615|NCT00410410|O5|Outcome|IP Cohort 2 (IP2C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479616|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479617|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479618|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479619|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479620|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479621|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479622|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479623|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479624|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479625|NCT00410410|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479626|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479627|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479628|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479629|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479630|NCT00410410|O2|Outcome|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479631|NCT00410410|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479632|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479633|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479634|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479635|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479636|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479637|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479638|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479639|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479640|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479641|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479642|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479643|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479644|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479645|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479646|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479647|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479648|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479649|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479650|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479651|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479652|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479729|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479653|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479654|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479655|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479656|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479657|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479658|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479659|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479660|NCT00410410|O4|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479661|NCT00410410|O3|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479662|NCT00410410|O2|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479663|NCT00410410|O1|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479664|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479665|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479666|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479667|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479668|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479669|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479670|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479671|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479672|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479673|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg,|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg.
479674|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479675|NCT00410410|O1|Outcome|IP1C-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg.
479676|NCT00410410|O4|Outcome|IP1C-Placebo|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479677|NCT00410410|O3|Outcome|IP1C-ABA 3 mg/kg|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479678|NCT00410410|O2|Outcome|IP1C-ABA ~10 mg/kg|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29,and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479679|NCT00410410|O1|Outcome|Induction Period Cohort 1 (IP1C)-ABA 30/~10 mg/kg|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). Following this, on Days IP-29 and IP-57 abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479680|NCT00410410|E9|Reported Event|Placebo, MP|During the MP, placebo was administered IV every 28 days beginning Day MP-1 through Day MP-337.
479681|NCT00410410|E8|Reported Event|Placebo, IP1C|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
479682|NCT00410410|E7|Reported Event|ABA ~10 mg/kg, OL|During OL, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day OL-1.
479683|NCT00410410|E6|Reported Event|ABA ~10mg/kg, MP|During MP, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered) every 28 days beginning Day MP-1.
479684|NCT00410410|E5|Reported Event|ABA ~10mg/kg,IP2C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479685|NCT00410410|E4|Reported Event|ABA ~10 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1,IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
479686|NCT00410410|E3|Reported Event|ABA 3 mg/kg,IP1C|During IP, abatacept was administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
479687|NCT00410410|E2|Reported Event|ABA 30/~10mg/kg,IP2C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg.
479730|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479688|NCT00410410|E1|Reported Event|ABA 30/~10 mg/kg,IP1C|During IP, abatacept was administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered).
479689|NCT00410384|B4|Baseline|Total|Total of all reporting groups
479690|NCT00410384|B3|Baseline|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479691|NCT00410384|B2|Baseline|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479692|NCT00410384|B1|Baseline|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479693|NCT00410384|P3|Participant Flow|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479694|NCT00410384|P2|Participant Flow|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479695|NCT00410384|P1|Participant Flow|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479696|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479697|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479698|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479699|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479700|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479701|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479702|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479703|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479704|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479705|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479706|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479707|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479708|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479709|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479710|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479711|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479712|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479713|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479714|NCT00410384|O3|Outcome|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479715|NCT00410384|O2|Outcome|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479716|NCT00410384|O1|Outcome|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479717|NCT00410384|E3|Reported Event|Belimumab 10 mg/kg|Belimumab 10 mg/kg IV plus standard therapy; belimumab 10 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479718|NCT00410384|E2|Reported Event|Belimumab 1 mg/kg|Belimumab 1 mg/kg IV plus standard therapy; belimumab 1 mg/kg administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479719|NCT00410384|E1|Reported Event|Placebo|Placebo IV plus standard therapy; placebo administered on Days 0, 14, 28, and every 28 days thereafter through 72 weeks.
479720|NCT00410280|B3|Baseline|Total|Total of all reporting groups
479721|NCT00410280|B2|Baseline|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479722|NCT00410280|B1|Baseline|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479723|NCT00410280|P2|Participant Flow|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479724|NCT00410280|P1|Participant Flow|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479725|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479726|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479727|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479728|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
482392|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
479731|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479732|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479733|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479734|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479735|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479736|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479737|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479738|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479739|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479740|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479741|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479742|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479743|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479744|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479745|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479746|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479747|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479748|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479749|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479750|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479751|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479752|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479753|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479754|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479755|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479756|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479757|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479758|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479759|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479760|NCT00410280|O2|Outcome|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479761|NCT00410280|O1|Outcome|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479762|NCT00410280|E2|Reported Event|Placebo|Placebo matched to IMA-638 subcutaneous injection on Day 1 and 8.
479763|NCT00410280|E1|Reported Event|IMA-638 2mg/kg|IMA-638 2 milligram/kilogram (mg/kg) subcutaneous injection on Day 1 and 8.
479764|NCT00410202|B4|Baseline|Total|Total of all reporting groups
479765|NCT00410202|B3|Baseline|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
479766|NCT00410202|B2|Baseline|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479767|NCT00410202|B1|Baseline|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
479768|NCT00410202|P3|Participant Flow|Adefovir + Lamivudine (ADV+LVD) Combination Therapy|ADV 10 mg + LVD 100 mg; Combination therapy given QD for 100 weeks
479769|NCT00410202|P2|Participant Flow|Entecavir (ETV) Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479770|NCT00410202|P1|Participant Flow|Entecavir + Adefovir (ETV+ADV) Combination Therapy|ETV 1.0 mg + ADV 10 mg; Combination therapy given once daily (QD) for 100 weeks
479771|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479772|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479773|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
479774|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479775|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479776|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
479777|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479778|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479779|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; QD for 100 weeks
479780|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479781|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
482393|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
479782|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479783|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479784|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479785|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479786|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479787|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479788|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479789|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479790|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479791|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479792|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479793|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479794|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479795|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479796|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479797|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479798|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479799|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479800|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479801|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479802|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479803|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479804|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479805|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479806|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479807|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479808|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479809|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479810|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479811|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479812|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479813|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479814|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator’s discretion, and where permitted by the local health authorities and ethics committees.
479815|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479816|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479817|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479818|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479819|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479820|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479821|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479822|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479823|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479824|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479825|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479826|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479827|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479828|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479829|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479830|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479831|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479832|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479833|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479834|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479835|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479836|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479837|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479838|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479839|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479840|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479841|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479842|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479843|NCT00410202|O3|Outcome|ADV+LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479844|NCT00410202|O2|Outcome|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479845|NCT00410202|O1|Outcome|ETV+ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479846|NCT00410202|E3|Reported Event|ETV + ADV Combination Therapy|ETV 1.0 mg + ADV 10 mg; once daily (QD) for 100 weeks
479847|NCT00410202|E2|Reported Event|ETV Monotherapy|ETV 1.0 mg; QD, for 100 weeks with an option of adding non-study tenofovir (TDF) at Week 48 at the investigator's discretion, and where permitted by the local health authorities and ethics committees.
479848|NCT00410202|E1|Reported Event|ADV + LVD Combination Therapy|ADV 10 mg + LVD 100 mg; QD for 100 weeks
479849|NCT00410189|B1|Baseline|ZD6474|ZD6474 300 mg by mouth daily.
479850|NCT00410189|P1|Participant Flow|ZD6474|ZD6474 300 mg by mouth daily.
479851|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
479852|NCT00410189|O1|Outcome|ZD6474|ZD6474 300 mg by mouth daily.
479853|NCT00410189|E1|Reported Event|ZD6474|ZD6474 300 mg by mouth daily.
479854|NCT00410163|B3|Baseline|Total|Total of all reporting groups
479855|NCT00410163|B2|Baseline|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479856|NCT00410163|B1|Baseline|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479857|NCT00410163|P2|Participant Flow|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
479858|NCT00410163|P1|Participant Flow|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses. After the last infusion, the disease status of the participants was evaluated every 3 months up to 18 months during the Follow-up Period. Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
479859|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479860|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479861|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479949|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
482394|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
479862|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479863|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479864|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479865|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479866|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479867|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479868|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479869|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479870|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479871|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479872|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479873|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479874|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479875|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479876|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479877|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479878|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479879|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479880|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479881|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
482395|NCT00402987|O3|Outcome|Placebo|
479882|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479883|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479884|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479885|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479886|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479887|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479888|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479889|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479890|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479891|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479892|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479893|NCT00410163|O2|Outcome|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479894|NCT00410163|O1|Outcome|Ofatumumab 500 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479895|NCT00410163|E4|Reported Event|Ofatumumab 1000 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative CLL therapy was initiated, or until Month 60.
479896|NCT00410163|E3|Reported Event|Ofatumumab 500 mg + FC: Extended Follow-up Phase|Participants were monitored in the Extended Follow-up Phase every 6 months for survival until alternative Chronic Lymphocyte Leukemia (CLL) therapy was initiated, or until Month 60.
479897|NCT00410163|E2|Reported Event|Ofatumumab 1000 mg + FC|Ofatumumab iv infusion initiated at 300 mg for course 1, followed by dose of 1000 mg for courses 2-6 in combination with fludarabine iv (25 mg/m^2 daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479898|NCT00410163|E1|Reported Event|Ofatumumab 500 mg + Fludarabine and Cyclophosphamide (FC)|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg) for course 1, followed by dose of 500 mg for courses 2-6 in combination with fludarabine iv (25 mg/meters squared [m^2] daily on Days 1-3) and cyclophosphamide iv (250 mg/m^2 daily on Days 1-3) administered every 4 weeks for a total of 6 courses
479899|NCT00410150|B3|Baseline|Total|Total of all reporting groups
479900|NCT00410150|B2|Baseline|Control Group|Subjects randomized to the control arm of the study
479901|NCT00410150|B1|Baseline|Heliox Group|Patients randomized to the Heliox arm of the study
479902|NCT00410150|P2|Participant Flow|Control Group|Subjects randomized to the control arm of the study
479903|NCT00410150|P1|Participant Flow|Heliox Group|Patients randomized to the Heliox arm of the study
479904|NCT00410150|O2|Outcome|Control Group|Subjects randomized to the control arm of the study
479905|NCT00410150|O1|Outcome|Heliox Group|Patients randomized to the Heliox arm of the study
479906|NCT00410150|E2|Reported Event|Control Group|Subjects randomized to the control arm of the study
479907|NCT00410150|E1|Reported Event|Heliox Group|Patients randomized to the Heliox arm of the study
479908|NCT00410124|B3|Baseline|Total|Total of all reporting groups
479950|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479951|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
482396|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
479909|NCT00410124|B2|Baseline|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479910|NCT00410124|B1|Baseline|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479911|NCT00410124|P2|Participant Flow|Placebo + BSC / RAD001|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479912|NCT00410124|P1|Participant Flow|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479913|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479914|NCT00410124|O1|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479915|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479916|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
479917|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479918|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
479919|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479920|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
479921|NCT00410124|O2|Outcome|Day 15|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 15 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed.
479922|NCT00410124|O1|Outcome|Day 1|Pharmacokinetic Blood Sampling: Full pharmacokinetic profile assessments on Cycle 1, Day 1 (at pre-dose and at 1h, 2h, 5h, and 24h post-dose) were performed. Troughs were collected for all patients on Day 1 of each treatment Cycle from month 2 until discontinuation from the study drug.
479923|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479924|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479925|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479926|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479927|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479952|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479928|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479929|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479930|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479931|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479932|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479933|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479934|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479935|NCT00410124|O2|Outcome|Placebo + BSC|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care. With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479936|NCT00410124|O1|Outcome|RAD001 +BSC|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479937|NCT00410124|E3|Reported Event|Randomized to Placebo + BSC (Double Blind Only)|Patients received matching placebo of RAD001 tablets twice a day along with Best Supportive Care.
479938|NCT00410124|E2|Reported Event|Randomized to Placebo + BSC (Open Label)|With the documented disease progression at data cutoff of 28Feb2008, the investigator could unblind the patient. If unblinded patient was receiving placebo treatment, they were given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479939|NCT00410124|E1|Reported Event|Randomized to RAD001+ BSC ( Blinded + Open Label)|The study drugs were self administered by the patients. Patients were instructed to take the study drug as specified in the protocol. Patients were instructed to take two tablets (5 mg each) by mouth every day. Tablets were to be taken one tablet after another with a glass of water, at the same time each day in a fasting state or with a light fat-free meal. If disease progression occurred at data cutoff of 28Feb2008, patients were unblinded and if they were receiving RAD001, they would discontinue the study. Otherwise, they would be given the option to continue in the extension open label phase of 2 tablets of RAD001 5mg by mouth every day.
479940|NCT00410072|B3|Baseline|Total|Total of all reporting groups
479941|NCT00410072|B2|Baseline|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479942|NCT00410072|B1|Baseline|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479943|NCT00410072|P2|Participant Flow|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479944|NCT00410072|P1|Participant Flow|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479945|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479946|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479947|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479948|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479953|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479954|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479955|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479956|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479957|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479958|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479959|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479960|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479961|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479962|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479963|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479964|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479965|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479966|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479967|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479968|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479969|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479970|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479971|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479972|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479973|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479974|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479975|NCT00410072|O2|Outcome|ETV 0.5 mg +TDF 300 mg|ETV 0.5 mg plus Tenofovir (TDF) 300 mg combination therapy given QD for 100 weeks
479976|NCT00410072|O1|Outcome|ETV 0.5 mg|Entecavir (ETV) 0.5 mg monotherapy given once daily (QD) for 100 weeks
479977|NCT00410072|E2|Reported Event|ETV/TDF 0.5 mg +TDF 300 mg|ETV 0.5 mg plus TDF 300 mg combination therapy given once daily (QD) for 100 weeks
479978|NCT00410072|E1|Reported Event|ETV 0.5 mg|ETV 0.5 mg monotherapy given QD for 100 weeks
479979|NCT00410046|B1|Baseline|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479980|NCT00410046|P1|Participant Flow|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479981|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479982|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479983|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479984|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479985|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479986|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479987|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479988|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479989|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479990|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479991|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479992|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479993|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479994|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479995|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479996|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479997|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479998|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
479999|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480000|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480001|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480002|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480003|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480004|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480005|NCT00410046|O2|Outcome|SSZ / ETN|Patients received Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480006|NCT00410046|O1|Outcome|Etanercept / ETN|Patients received ETN dose 50 mg once weekly in study 0881A3-402 for 16 weeks. Upon enrollment into study 405, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480007|NCT00410046|E1|Reported Event|Etanercept|Patients received ETN dose 50 mg once weekly or Sulphasalazine dose 3 g daily in study 0881A3-402 for 16 weeks. Upon enrollment into this study, all received subcutaneous injections of etanercept 50 mg once weekly for 36 weeks.
480008|NCT00409838|B3|Baseline|Total|Total of all reporting groups
480009|NCT00409838|B2|Baseline|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480010|NCT00409838|B1|Baseline|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480011|NCT00409838|P2|Participant Flow|Placebo|Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).
480012|NCT00409838|P1|Participant Flow|Abatacept, 10 mg/kg|"Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141 (6-month treatment).~Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg."
480013|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480014|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480015|NCT00409838|O2|Outcome|Placebo|Short-term Period. Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480016|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480017|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480018|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480051|NCT00409838|O2|Outcome|Abatacept 750 mg|
480052|NCT00409838|O1|Outcome|Abatacept 500 mg|
480053|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480054|NCT00409838|O2|Outcome|Abatacept 750 mg|
480019|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480020|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480021|NCT00409838|O2|Outcome|Placebo|Short-term Period: Participants received placebo IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480022|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480023|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480024|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480025|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480026|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480027|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo was administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480028|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Participants received a body-weight tiered dose of abatacept approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. Long-term Period: Participants who completed the Short-term Period received treatment with abatacept, administered IV at a weight-tiered dose approximately 10 mg/kg.
480029|NCT00409838|O2|Outcome|Placebo|Short-term Period: Placebo administered IV on Days 1, 15, and 29 and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
480030|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Short-term Period: Abatacept administered IV in a body-weight tiered dose approximating 10 mg/kg. Study medication was administered on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141. LTE Period: Abatacept, administered IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months on a background of methotrexate.
480031|NCT00409838|O1|Outcome|All Treated|Abatacept was administered intravenously monthly at a fixed dose of approximately 10 mg/kg in the LTE period on a background of methotrexate
480032|NCT00409838|O1|Outcome|All Treated|Abatacept, administered intravenously IV monthly at a fixed dose of approximately 10 mg/kg for an average of approximately 41 months in the LTE period on a background of methotrexate
480033|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480034|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480035|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480036|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480037|NCT00409838|O1|Outcome|Abatacept + Background Methotrexate|Dosage: 500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480038|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480039|NCT00409838|O2|Outcome|Abatacept 750 mg|
480040|NCT00409838|O1|Outcome|Abatacept 500 mg|
480041|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480042|NCT00409838|O2|Outcome|Abatacept 750 mg|
480043|NCT00409838|O1|Outcome|Abatacept 500 mg|
480044|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480045|NCT00409838|O2|Outcome|Abatacept 750 mg|
480046|NCT00409838|O1|Outcome|Abatacept 500 mg|
480047|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480048|NCT00409838|O2|Outcome|Abatacept 750 mg|
480049|NCT00409838|O1|Outcome|Abatacept 500 mg|
480050|NCT00409838|O3|Outcome|Abatacept 500 mg and 750 mg|
480056|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480057|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480058|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480059|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480060|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480061|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480062|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480063|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480064|NCT00409838|O2|Outcome|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480065|NCT00409838|O1|Outcome|Abatacept|Dosage: 500 mg to 1 g; participants randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480066|NCT00409838|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
480067|NCT00409838|O1|Outcome|Abatacept|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
480068|NCT00409838|O2|Outcome|Placebo|Participants received placebo IV on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
480069|NCT00409838|O1|Outcome|Abatacept, 10 mg/kg|Participants received abatacept in a body-weight tiered dose approximating 10 mg/kg intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141.
480070|NCT00409838|E2|Reported Event|Placebo|Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480071|NCT00409838|E1|Reported Event|Abatacept 10 mg/kg|500 mg to 1 g; subjects randomized to the abatacept group received a body-weight tiered dose approximating 10 mg/kg. Study medication was administered intravenously (IV) on Days 1, 15, and 29, and every 28 days thereafter up to and including Day 141 (6 month treatment).
480072|NCT00409825|B1|Baseline|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
480073|NCT00409825|P1|Participant Flow|AUC1 vs AUC2|"AUC 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection.~AUC 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection."
480074|NCT00409825|O1|Outcome|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection.
480075|NCT00409825|E1|Reported Event|Part 1|Part 1 done after 4 weekly 17-OHPC injections completed, between 20 6/7 to 24 6/7 weeks gestation. 10 cc blood drawn pre-5th injection. 10 cc blood drawn 12 hours post-dose and 7 consecutive days. 24-hour urine collected days 4-5 within 7 days post-injection. Part 2 done 31 0/7 to 34 6/7 or at 35 0/7 weeks. 10 cc blood drawn pre weekly injection, 12 hours post-dose, and 7 consecutive days. 24-hour urine collected between days 4-5 within 7 days post-injection. A subject in whom Part 2 is performed during the last scheduled injection of 17-OHPC (at or around 35 0/7 weeks) will have the option to participate in Part 4, in which 10 cc of blood will be drawn serially over 21 days after completing Part 2. Blood will be drawn on days 9, 11, 14, 17, 20, 24, 28 after the last injection. Part 3: At the time of labor and delivery, subject will have 10cc of blood removed from a maternal peripheral vein. 10cc of blood will be collected from the placenta/umbilical cord after delivery.
480076|NCT00409786|B1|Baseline|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
480077|NCT00409786|P1|Participant Flow|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
480078|NCT00409786|O1|Outcome|Group 1|All participants
480079|NCT00409786|E1|Reported Event|VLM Online Lifestyle Counseling|Overweight primary care patient participants receiving the Virtual Lifestyle Management (VLM) Program online lifestyle counseling intervention.
480080|NCT00409773|B6|Baseline|Total|Total of all reporting groups
480081|NCT00409773|B5|Baseline|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480082|NCT00409773|B4|Baseline|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480083|NCT00409773|B3|Baseline|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480084|NCT00409773|B2|Baseline|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480085|NCT00409773|B1|Baseline|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480086|NCT00409773|P5|Participant Flow|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480087|NCT00409773|P4|Participant Flow|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480088|NCT00409773|P3|Participant Flow|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480089|NCT00409773|P2|Participant Flow|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480090|NCT00409773|P1|Participant Flow|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480091|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480092|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480093|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480094|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480095|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480096|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480097|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480098|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480099|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480100|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480101|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480102|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480103|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480104|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480105|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480106|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480107|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480108|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480109|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480110|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480111|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480112|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480113|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480114|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480115|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480116|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480117|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480118|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480119|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480120|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480121|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480122|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480123|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480124|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480125|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480126|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480127|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480128|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480129|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480130|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480131|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480132|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480133|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480134|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480135|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480136|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480137|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480138|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480139|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480140|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480141|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480142|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480143|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480319|NCT00409344|E2|Reported Event|Dexmedetomidine|This group will receive dexmedetomidine
480144|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480145|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480146|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480147|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480148|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480149|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480150|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480151|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480152|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480153|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480154|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480155|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480156|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480157|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480158|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480159|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480160|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480161|NCT00409773|O5|Outcome|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480162|NCT00409773|O4|Outcome|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480163|NCT00409773|O3|Outcome|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480164|NCT00409773|O2|Outcome|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480165|NCT00409773|O1|Outcome|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480166|NCT00409773|E5|Reported Event|Atorva 40 mg|Atorvastatin 40 mg once daily for 6 weeks
480167|NCT00409773|E4|Reported Event|EZ/Simva 10 mg/40 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/40 mg
480168|NCT00409773|E3|Reported Event|Atorva 20mg|Atorvastatin 20 mg once daily for 6 weeks
480169|NCT00409773|E2|Reported Event|EZ/Simva 10 mg/20 mg|Ezetimibe (+) simvastatin combination tablet at doses of 10/20 mg
480170|NCT00409773|E1|Reported Event|Atorva 10 mg|Atorvastatin 10 mg once daily for 6 weeks
480171|NCT00409747|B1|Baseline|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
480172|NCT00409747|P1|Participant Flow|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
480173|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
480174|NCT00409747|O1|Outcome|Minocycline|Open-label minocycline treatment at 1.4 mg/kg/day
480175|NCT00409747|E1|Reported Event|Overall Study/Minocycline|
480176|NCT00409708|B3|Baseline|Total|Total of all reporting groups
480177|NCT00409708|B2|Baseline|Behavior Therapy|0 mg/day Ritalin LA
480178|NCT00409708|B1|Baseline|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480179|NCT00409708|P2|Participant Flow|Behavior Therapy|0 mg/day Ritalin LA
480180|NCT00409708|P1|Participant Flow|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480181|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480182|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480183|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480184|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480185|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480186|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480187|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480188|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480189|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480190|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480191|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480192|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480193|NCT00409708|O2|Outcome|Behavior Therapy|0 mg/day Ritalin LA
480194|NCT00409708|O1|Outcome|Ritalin LA Plus Behavior Therapy|10-60 mg/day
480195|NCT00409708|E2|Reported Event|Behavior|Behavior
480196|NCT00409708|E1|Reported Event|Ritalin+Behavior|Ritalin+Behavior
480197|NCT00409682|B4|Baseline|Total|Total of all reporting groups
480198|NCT00409682|B3|Baseline|Low-Dose Adalimumab: 20 mg or 10 mg (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480199|NCT00409682|B2|Baseline|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480269|NCT00409539|B2|Baseline|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480200|NCT00409682|B1|Baseline|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing greater than or equal to 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing less than 40 kg at Baseline received 80 mg at Week 0 and 40mg at Week 2.
480201|NCT00409682|P3|Participant Flow|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 20 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480202|NCT00409682|P2|Participant Flow|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] ≥ 40 kg) or 10 mg adalimumab eow (if Week 4 BW < 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480203|NCT00409682|P1|Participant Flow|Open-label Adalimumab (Week 0 to Week 4)|All subjects received an open-label adalimumab induction regimen. Subjects weighing ≥ 40 kg at Baseline received 160 mg at Week 0 and 80 mg at Week 2. Subjects weighing < 40 kg at Baseline received 80 mg at Week 0 and 40 mg at Week 2.
480204|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480205|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480206|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480207|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480208|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480209|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480210|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480240|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480211|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480212|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480213|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480214|NCT00409682|O2|Outcome|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|Subjects randomized to the High-Dose treatment group received either 40 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 20 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blinded (DB) ew therapy they could be switched to open-label ew therapy.
480215|NCT00409682|O1|Outcome|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|Subjects randomized to the Low-Dose treatment group received either 20 mg adalimumab every other week (eow) (if Week 4 body weight [BW] was greater than or equal to 40 kg) or 10 mg adalimumab eow (if Week 4 BW less than 40 kg). Starting at the Week 12 study visit, subjects who experienced a disease flare or were non-responders could be switched from blinded eow dosing to blinded every week (ew) dosing, continuing with the same blinded dose. If a subject continued to experience a flare or met the definition of non-response following an 8-week course of double-blind (DB) ew therapy they could be switched to open-label ew therapy.
480216|NCT00409682|E3|Reported Event|High-Dose Adalimumab: 40 mg or 20 mg Eow (Week 4 to Week 52)|
480217|NCT00409682|E2|Reported Event|Low-Dose Adalimumab: 20 mg or 10 mg Eow (Week 4 to Week 52)|
480218|NCT00409682|E1|Reported Event|Open-label Adalimumab (Week 0 to Week 4)|
480219|NCT00409617|B1|Baseline|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480220|NCT00409617|P1|Participant Flow|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480221|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480222|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480223|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480241|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480224|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480225|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480226|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480227|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480228|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480229|NCT00409617|O1|Outcome|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480230|NCT00409617|E1|Reported Event|Open Label Adalimumab 40 mg Every Other Week or Every Week|Participants received adalimumab 160 mg by subcutaneous injection at Week 0 and adalimumab 80 mg by subcutaneous injection at Week 2. Beginning at Week 4 of the study, participants received adalimumab 40 mg every other week. Beginning at Week 12, participants who experienced a disease flare (increase in Harvey Bradshaw Index of 3 or more compared to Week 4 and a total Index score of 7 or higher) and participants who did not respond to every other week treatment (non-response defined as a decrease in HBI by fewer than 3 points compared to Baseline) could switch to adalimumab 40 mg every week.
480231|NCT00409578|B5|Baseline|Total|Total of all reporting groups
480232|NCT00409578|B4|Baseline|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480233|NCT00409578|B3|Baseline|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480234|NCT00409578|B2|Baseline|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480235|NCT00409578|B1|Baseline|Placebo|Placebo tablets and capsules
480236|NCT00409578|P4|Participant Flow|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480237|NCT00409578|P3|Participant Flow|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480238|NCT00409578|P2|Participant Flow|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480239|NCT00409578|P1|Participant Flow|Placebo|Placebo tablets and capsules
480242|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480243|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
480244|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480245|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480246|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480247|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
480248|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480249|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480250|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480251|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
480252|NCT00409578|O4|Outcome|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480253|NCT00409578|O3|Outcome|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480254|NCT00409578|O2|Outcome|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480255|NCT00409578|O1|Outcome|Placebo|Placebo tablets and capsules
480256|NCT00409578|E4|Reported Event|Aliskiren/Valsartan 300/320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study. Beginning with Week 4, in addition to 320 mg valsartan, patients were treated with 75 mg of aliskiren (tablets); 1 week later patients were titrated up to 150 mg of aliskiren and 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480257|NCT00409578|E3|Reported Event|Valsartan 320 mg|Following 1 week of treatment with 80 mg of valsartan (capsules), patients in this arm were titrated up to 160 mg of valsartan; 1 week later they were titrated up to 320 mg valsartan for the remainder of the study.
480258|NCT00409578|E2|Reported Event|Aliskiren 300 mg|Following 1 week of treatment with 75 mg of aliskiren (tablets), patients in this arm were titrated up to 150 mg of aliskiren; 1 week later they were titrated up to 300 mg aliskiren for the remainder of the study.
480259|NCT00409578|E1|Reported Event|Placebo|Placebo tablets and capsules
480260|NCT00409565|B1|Baseline|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
480261|NCT00409565|P1|Participant Flow|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
480262|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
480263|NCT00409565|O1|Outcome|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
480264|NCT00409565|E1|Reported Event|Cetuximab Plus Bevacizumab|"Cetuximab plus bevacizumab~Cetuximab: • Cetuximab 400 mg/m2 IV over 120 minutes on day 1 of cycle 1 ONLY~• Cetuximab dose will be 250 mg/m2 IV over 60 minutes weekly on ALL subsequent administrations~Bevacizumab: Once every 3 weeks, 15 mg/kg of bevacizumab will be given by IV infusion after cetuximab has been given"
480265|NCT00409539|B6|Baseline|Total|Total of all reporting groups
480266|NCT00409539|B5|Baseline|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480267|NCT00409539|B4|Baseline|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480268|NCT00409539|B3|Baseline|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480270|NCT00409539|B1|Baseline|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
480271|NCT00409539|P5|Participant Flow|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480272|NCT00409539|P4|Participant Flow|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480273|NCT00409539|P3|Participant Flow|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480274|NCT00409539|P2|Participant Flow|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480275|NCT00409539|P1|Participant Flow|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
480276|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480277|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480278|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480279|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480280|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
480281|NCT00409539|O5|Outcome|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480282|NCT00409539|O4|Outcome|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480283|NCT00409539|O3|Outcome|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480284|NCT00409539|O2|Outcome|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480285|NCT00409539|O1|Outcome|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
480286|NCT00409539|E5|Reported Event|120mg Dose of SMP-986|"120mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480287|NCT00409539|E4|Reported Event|80mg Dose of SMP-986|"80mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480288|NCT00409539|E3|Reported Event|40mg Dose of SMP-986|"40mg dose of SMP-986 to be taken for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480289|NCT00409539|E2|Reported Event|20mg Dose of SMP-986|"20mg dose of SMP-986 to be taken once daily for 8 week duration.~SMP-986: Comparison of varying dosages (20, 40, 80 or 120mg) of SMP-986 against placebo. Dosing is to occur once daily, in the morning, for a duration of 8 weeks"
480290|NCT00409539|E1|Reported Event|Placebo|"Placebo run-in phase. 2 week duration.~Placebo: Placebo, 2 week duration."
480291|NCT00409409|B3|Baseline|Total|Total of all reporting groups
480292|NCT00409409|B2|Baseline|Placebo|Placebo tablet
480293|NCT00409409|B1|Baseline|300 IR|300 IR grass pollen allergen extract tablet
480294|NCT00409409|P2|Participant Flow|Placebo|Placebo tablet
480295|NCT00409409|P1|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
480296|NCT00409409|O2|Outcome|Placebo|Placebo tablet
480297|NCT00409409|O1|Outcome|300 IR|300 IR grass pollen allergen extract tablet
480298|NCT00409409|E2|Reported Event|Placebo|Placebo tablet
480299|NCT00409409|E1|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
480300|NCT00409344|B3|Baseline|Total|Total of all reporting groups
480301|NCT00409344|B2|Baseline|Dexmedetomidine|This group will receive dexmedetomidine
480302|NCT00409344|B1|Baseline|Saline|This group will recive saline
480303|NCT00409344|P2|Participant Flow|Dexmedetomidine|This group will receive dexmedetomidine
480304|NCT00409344|P1|Participant Flow|Saline|This group will recive saline
480305|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
480306|NCT00409344|O1|Outcome|Saline|This group will recive saline
480307|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
480308|NCT00409344|O1|Outcome|Saline|This group will recive saline
480309|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
480310|NCT00409344|O1|Outcome|Saline|This group will recive saline
480311|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
480312|NCT00409344|O1|Outcome|Saline|This group will recive saline
480313|NCT00409344|O2|Outcome|Dexmedetomidine|This group will receive dexmedetomidine
480314|NCT00409344|O1|Outcome|Saline|This group will recive saline
480321|NCT00409331|B1|Baseline|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
480322|NCT00409331|P1|Participant Flow|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
480323|NCT00409331|O1|Outcome|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
480324|NCT00409331|E1|Reported Event|IMRT + Amifostine|Intensity-Modulated Radiation Therapy (IMRT) 2.0 to 2.2 Gy delivered in 30 fractions + Amifostine 500 mg, 2 divided doses subcutaneously 30-60 minutes prior to IMRT.
480325|NCT00409292|B1|Baseline|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
480326|NCT00409292|P1|Participant Flow|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment."
480327|NCT00409292|O1|Outcome|RAD001|"RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.~Four weeks of study drug was considered to be one cycle of treatment.~RAD001: Taken orally daily for as long as the participant continues to receive a benefit."
480328|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
480329|NCT00409292|O1|Outcome|RAD001|RAD001: Taken orally daily for as long as the participant continues to receive a benefit.
480330|NCT00409292|O1|Outcome|RAD001|RAD001 was administered continuously at a dose of 10 mg daily by mouth until disease progression, unacceptable toxicity, or withdrawal of consent.
480331|NCT00409292|E1|Reported Event|RAD001|
480332|NCT00409240|B3|Baseline|Total|Total of all reporting groups
480333|NCT00409240|B2|Baseline|Usual Care|Patient continued on usual care
480334|NCT00409240|B1|Baseline|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
480335|NCT00409240|P2|Participant Flow|Usual Care|Patient continued on usual care
480336|NCT00409240|P1|Participant Flow|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
480337|NCT00409240|O2|Outcome|Usual Care|Patient continued on usual care
480338|NCT00409240|O1|Outcome|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
480339|NCT00409240|E2|Reported Event|Usual Care|Patient continued on usual care
480340|NCT00409240|E1|Reported Event|MEDIC Intervention|"Receives pharmacist-led behavioral and pharmacologic group intervention for cardiac risk reduction~MEDIC: Multidisciplinary Education and Diabetes Intervention for Cardiac risk reduction (MEDIC; a pharmacist-led behavioral and pharmacologic intervention in groups."
480341|NCT00409188|B3|Baseline|Total|Total of all reporting groups
480342|NCT00409188|B2|Baseline|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480343|NCT00409188|B1|Baseline|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480344|NCT00409188|P2|Participant Flow|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480345|NCT00409188|P1|Participant Flow|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480346|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480347|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480374|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
482397|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
480348|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480349|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480350|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480351|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480352|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480353|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480354|NCT00409188|O2|Outcome|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480355|NCT00409188|O1|Outcome|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480356|NCT00409188|E2|Reported Event|Saline + Placebo|A single intravenous infusion of 0.9 percent (%) saline solution in the same calculated dose as cyclophosphamide was given 3 days before first placebo vaccination. After receiving saline, participants received 8 consecutive weekly subcutaneous vaccinations with placebo at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance placebo vaccinations at 6-week intervals, commencing at Week 13, until disease progression was documented.
480357|NCT00409188|E1|Reported Event|Tecemotide (L-BLP25) + Cyclophosphamide|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before first tecemotide (L-BLP25) vaccination. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 806 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 806 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until disease progression was documented.
480358|NCT00409175|B3|Baseline|Total|Total of all reporting groups
480359|NCT00409175|B2|Baseline|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480360|NCT00409175|B1|Baseline|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480361|NCT00409175|P2|Participant Flow|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480362|NCT00409175|P1|Participant Flow|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480363|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480364|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480365|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480366|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480367|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480368|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480369|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480370|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480371|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480372|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480373|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480375|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480376|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480377|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480378|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480379|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480380|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480381|NCT00409175|O2|Outcome|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480382|NCT00409175|O1|Outcome|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480383|NCT00409175|E2|Reported Event|Placebo|Placebo, matched to tafamidis (Fx-1006A) 20 mg capsule, orally once daily for 18 months.
480384|NCT00409175|E1|Reported Event|Tafamidis|Tafamidis (Fx-1006A) 20 milligram (mg) capsule orally once daily for 18 months.
480385|NCT00409006|B3|Baseline|Total|Total of all reporting groups
480386|NCT00409006|B2|Baseline|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480387|NCT00409006|B1|Baseline|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480388|NCT00409006|P2|Participant Flow|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480389|NCT00409006|P1|Participant Flow|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480390|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480391|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480392|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480393|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480394|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480395|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480396|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480397|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480398|NCT00409006|O2|Outcome|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480399|NCT00409006|O1|Outcome|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480400|NCT00409006|E2|Reported Event|Pemetrexed/Cisplatin|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
480401|NCT00409006|E1|Reported Event|Pemetrexed/Cisplatin/Gefitinib|Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity.
480403|NCT00408993|B2|Baseline|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480404|NCT00408993|B1|Baseline|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480405|NCT00408993|P2|Participant Flow|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480406|NCT00408993|P1|Participant Flow|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480407|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480408|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480409|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480410|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480411|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480412|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480413|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480414|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480415|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480416|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480417|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480418|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480419|NCT00408993|O4|Outcome|Placebo - Evening Dosing|Placebo QD, PO for 12 weeks
480420|NCT00408993|O3|Outcome|Placebo - Morning Dosing|Placebo QD, PO for 12 weeks
480421|NCT00408993|O2|Outcome|Duloxetine - Evening Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480422|NCT00408993|O1|Outcome|Duloxetine - Morning Dosing|60 mg QD (morning or evening), PO for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480423|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480424|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480425|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480426|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480427|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480428|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480429|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480430|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480431|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480432|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480433|NCT00408993|O2|Outcome|Placebo|Placebo every day (QD), by mouth (PO) for 12 weeks
480434|NCT00408993|O1|Outcome|Duloxetine|60 mg every day (QD) (morning or evening), by mouth (PO) for 12 weeks (at week 2, dose can be increased to 120 mg at investigator discretion based on response)
480435|NCT00408993|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
480436|NCT00408993|E1|Reported Event|Placebo|Placebo
480437|NCT00408928|B1|Baseline|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
480438|NCT00408928|P1|Participant Flow|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
480439|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
480440|NCT00408928|O1|Outcome|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
480441|NCT00408928|E1|Reported Event|Bortezomib for Treatment of GHVD|Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.
480442|NCT00408902|B1|Baseline|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
480443|NCT00408902|P1|Participant Flow|TandutinibTreatment|Patients receive oral tandutinib 500 mg twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
480444|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
480492|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
482398|NCT00402987|O4|Outcome|Placebo|
480445|NCT00408902|O1|Outcome|TandutinibTreatment|Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
480446|NCT00408902|E1|Reported Event|TandutinibTreatment|"Patients receive oral tandutinib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~tandutinib: Given orally~laboratory biomarker analysis: Correlative studies"
480447|NCT00408876|B5|Baseline|Total|Total of all reporting groups
480448|NCT00408876|B4|Baseline|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480449|NCT00408876|B3|Baseline|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480450|NCT00408876|B2|Baseline|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480451|NCT00408876|B1|Baseline|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480452|NCT00408876|P4|Participant Flow|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480453|NCT00408876|P3|Participant Flow|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480454|NCT00408876|P2|Participant Flow|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480455|NCT00408876|P1|Participant Flow|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480456|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480457|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480458|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480459|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480460|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480461|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480462|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480463|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480464|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480465|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480466|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480467|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480468|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480469|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480470|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480471|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480472|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480473|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480474|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480475|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480476|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480477|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480478|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480479|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480480|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480481|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480482|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480483|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480484|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480485|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480486|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480487|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480488|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480489|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480490|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480491|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480493|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480494|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480495|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480496|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480497|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480498|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480499|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480500|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480501|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480502|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480503|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480504|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480505|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480506|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480507|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480508|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480509|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480510|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480511|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480512|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480513|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480514|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480515|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480516|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480517|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480518|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480519|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480520|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480521|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480522|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480523|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480524|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480525|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480526|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480527|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480528|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480529|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480530|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480531|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480532|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480533|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480534|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480535|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480536|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480537|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480538|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480539|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480540|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
482399|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
480541|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480542|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480543|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480544|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480545|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480546|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480547|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480548|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480549|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480550|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480551|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480552|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480553|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480554|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480555|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480556|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480557|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480558|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480559|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480560|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480561|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480562|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480563|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480564|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480565|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480566|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480567|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480568|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480569|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480570|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480571|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480572|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480573|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480574|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480575|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480576|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480577|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480578|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480579|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480580|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480581|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480582|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480583|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480584|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480585|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480586|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480587|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480588|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
482400|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
480589|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480590|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480591|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480592|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480593|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480594|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480595|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480596|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480597|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480598|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480599|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480600|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480601|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480602|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480603|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480604|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480605|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480606|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480607|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480608|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480609|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480610|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480611|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480612|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480613|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480614|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480615|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480616|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480617|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480618|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480619|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480620|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480621|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480622|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480623|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480624|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480625|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480626|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480627|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480628|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480629|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480630|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480631|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480632|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480633|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480634|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480635|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480636|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
482401|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
480637|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480638|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480639|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480640|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480641|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480642|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480643|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480644|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480645|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480646|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480647|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480648|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480649|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480650|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480651|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480652|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480653|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480654|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480655|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480656|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480657|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480658|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480659|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480660|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480661|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480662|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480663|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480664|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480665|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480666|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480667|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480668|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480669|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480670|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480671|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480672|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480673|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480674|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480675|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480676|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480677|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480678|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480679|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480680|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480681|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480682|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480683|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480684|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
482402|NCT00402987|O3|Outcome|Placebo|
480685|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480686|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480687|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480688|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480689|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480690|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480691|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480692|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480693|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480694|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480695|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480696|NCT00408876|O4|Outcome|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480697|NCT00408876|O3|Outcome|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480698|NCT00408876|O2|Outcome|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480699|NCT00408876|O1|Outcome|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480700|NCT00408876|E4|Reported Event|Placebo|placebo once a day (QD), by mouth (PO) for 13 weeks
480701|NCT00408876|E3|Reported Event|Duloxetine 120 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 1 week, then duloxetine 120 mg QD, PO for 11 weeks
480702|NCT00408876|E2|Reported Event|Duloxetine 60 mg|duloxetine 30 mg once a day (QD), by mouth (PO) for 1 week then duloxetine 60 mg QD, PO for 12 weeks
480703|NCT00408876|E1|Reported Event|Duloxetine 20 mg|duloxetine 20 mg once a day (QD), by mouth (PO) for 13 weeks
480704|NCT00408694|B1|Baseline|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
480705|NCT00408694|P1|Participant Flow|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
480706|NCT00408694|O1|Outcome|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity."
480707|NCT00408694|E1|Reported Event|Treatment (Bevacizumab, Cisplatin, Fluorouracil, IMRT, 3D-CRT)|"BEVACIZUMAB AND CHEMORADIOTHERAPY: Patients receive bevacizumab IV over 30-90 minutes and cisplatin IV over 20-30 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Beginning in week 1, patients also undergo three-dimensional conformal radiotherapy or intensity-modulated radiotherapy once daily 5 days a week for a total of 33 fractions.~ADJUVANT THERAPY: Beginning in week 10, patients receive fluorouracil IV continuously over 96 hours on days 1-4, cisplatin IV over 20-30 minutes on day 1, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity.~Data is reported for eligible patients with adverse event data who started study treatment, which is 44 patients."
480708|NCT00408681|B1|Baseline|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480709|NCT00408681|P1|Participant Flow|Arm I|Patients receive oral lithium carbonate once or twice daily orally. Treatment continues for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480710|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480711|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480712|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480750|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480713|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480714|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480715|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480716|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480717|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480718|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480719|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480720|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480721|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480722|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480723|NCT00408681|O1|Outcome|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480724|NCT00408681|E1|Reported Event|Arm I|Patients received oral lithium carbonate once or twice daily. Treatment continued for up to 8 weeks in the absence of disease progression or unacceptable toxicity.
480725|NCT00408629|B3|Baseline|Total|Total of all reporting groups
480726|NCT00408629|B2|Baseline|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480727|NCT00408629|B1|Baseline|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480728|NCT00408629|P2|Participant Flow|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480729|NCT00408629|P1|Participant Flow|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480730|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480731|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480732|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480733|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480734|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480735|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480736|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480737|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480738|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480739|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480740|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480741|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480742|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480743|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480744|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480745|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480746|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480747|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480748|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480749|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480751|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480752|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480753|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480754|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480755|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480756|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480757|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480758|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480759|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480760|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480761|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480762|NCT00408629|O2|Outcome|Placebo|The placebo treatment group received placebo throughout the Double-Blind (DB) period.
480763|NCT00408629|O1|Outcome|Adalimumab 160/80/40|During the Double-Blind (DB) period, the Adalimumab (ADA) treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480764|NCT00408629|E3|Reported Event|Any Adalimumab|During the Double-Blind period, only the Adalimumab treatment group received active study drug (dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 [160/80/40 mg]). After the switch to open-label treatment, participants in both treatment groups received adalimumab 40 mg eow, unless they dose-escalated, in which case they received adalimumab 40 mg every week (ew). Consequently, this analysis set combined adalimumab exposure from both the Double-Blind and Open-Label periods.
480765|NCT00408629|E2|Reported Event|Placebo Group - Double-Blind Period|The placebo treatment group received placebo throughout the Double-Blind period.
480766|NCT00408629|E1|Reported Event|Adalimumab Group - Double-Blind Period|During the Double-Blind period, the Adalimumab treatment group received a dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week (eow) starting at Week 4 (160/80/40 mg).
480767|NCT00408421|B3|Baseline|Total|Total of all reporting groups
480768|NCT00408421|B2|Baseline|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480769|NCT00408421|B1|Baseline|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480770|NCT00408421|P3|Participant Flow|Duloxetine 120 mg|Beginning at Week 7, patients receiving duloxetine 60 mg daily (QD) were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD
480771|NCT00408421|P2|Participant Flow|Duloxetine 60 mg|Patients randomly assigned to duloxetine 60 mg daily (QD) started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning at Week 7, patients on duloxetine 60 mg QD were re-randomized to either duloxetine 60 mg QD or duloxetine 120 mg QD.
480772|NCT00408421|P1|Participant Flow|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480773|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480774|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480775|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480776|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480777|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480778|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480779|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480780|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480885|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480886|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480781|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480782|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480783|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480784|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480785|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480786|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480787|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480788|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480789|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480790|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480791|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480792|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480793|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480794|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480795|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
480796|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
480797|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480798|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480799|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480800|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480801|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480802|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480803|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480804|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480805|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480806|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480807|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480808|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480887|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
481219|NCT00406653|P6|Participant Flow|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
480809|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480810|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480811|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480812|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480813|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480814|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480815|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480816|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480817|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480818|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480819|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480820|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480821|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480822|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480823|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480824|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480825|NCT00408421|O2|Outcome|Group 3 - Duloxetine 120mg|
480826|NCT00408421|O1|Outcome|Group 2 - Duloxetine 60mg|
480827|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480828|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480829|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480830|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480831|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480832|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480833|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480834|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480835|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480836|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480888|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
481221|NCT00406653|P4|Participant Flow|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
480837|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480838|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480839|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480840|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480841|NCT00408421|O2|Outcome|Duloxetine 60mg /120mg|Patients randomly assigned to duloxetine 60 mg QD started on duloxetine 30 mg QD for 1 week and then titrated up to duloxetine 60 mg QD for the following 6 weeks of the treatment phase. Beginning Week 7, patients assigned to duloxetine 60 mg were re-randomized to receive either duloxetine 60 mg or duloxetine 120 mg, and when combined are considered the Duloxetine 60mg/120mg group.
480842|NCT00408421|O1|Outcome|Placebo|placebo daily (QD), by mouth (PO) for 13 weeks
480843|NCT00408421|E2|Reported Event|Duloxetine 60/120 mg QD|Duloxetine 60/120 mg QD
480844|NCT00408421|E1|Reported Event|Placebo|Placebo
480845|NCT00408317|B1|Baseline|Entire Study Population|Includes all participants who received Ultrase® MT20 first and placebo first.
480846|NCT00408317|P2|Participant Flow|Placebo First, Then Ultrase®MT20|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the first intervention period followed by Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
480847|NCT00408317|P1|Participant Flow|Ultrase® MT20 First, Then Placebo|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in the first intervention period followed by placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in the second intervention period. Break period of 3 to 6 days and fixed dose second stabilization period of 4 days was maintained after first intervention period.
480848|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
480849|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
480850|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
480851|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
480852|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
480853|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
480854|NCT00408317|O2|Outcome|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
480855|NCT00408317|O1|Outcome|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion, for 6 to 7 days in either first intervention period or second intervention period.
480856|NCT00408317|E2|Reported Event|Placebo|Placebo matched to Ultrase® MT 20 capsules orally daily for 6 to 7 days in either first intervention period or second intervention period.
480857|NCT00408317|E1|Reported Event|Ultrase® MT20|Ultrase® MT 20 capsules containing enteric-coated minitablets orally daily at a dose stabilized during the first stabilization period (4 days), as per investigator's discretion,for 6 to 7 days in either first intervention period or second intervention period.
480858|NCT00408200|B3|Baseline|Total|Total of all reporting groups
480859|NCT00408200|B2|Baseline|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
480860|NCT00408200|B1|Baseline|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
480861|NCT00408200|P2|Participant Flow|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
482042|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
480862|NCT00408200|P1|Participant Flow|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
480863|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
480864|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
480865|NCT00408200|O2|Outcome|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
480866|NCT00408200|O1|Outcome|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
480867|NCT00408200|E2|Reported Event|AAD:YES|"Subjects receive membrane-active anti-arrhythmic medication after ablation. See intervention list below.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates.~propafenone; flecainide; sotalol; dofetilide : Above drugs prescribed per established guidelines for treatment of AF"
480868|NCT00408200|E1|Reported Event|AAD:NO|"Subjects do not receive membrane-active anti-arrhythmic medications after ablation.~Radiofrequency catheter ablation : A special catheter that delivers radiofrequency (heat) energy is advanced into the heart and used to destroy small areas of heart tissue responsible for causing atrial fibrillation. All catheters / devices used in the study are FDA approved for human use and currently being used to perform the AF ablation procedure in the United Sates."
480869|NCT00408070|B1|Baseline|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
480870|NCT00408070|P1|Participant Flow|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
480871|NCT00408070|O1|Outcome|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
480872|NCT00408070|E1|Reported Event|Bevacizumab Plus Carboplatin and Paclitaxel|This is a single Arm study. Two of the study drugs used are non-experimental. One of the study drugs is experimental.Cycle one - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Cycle two through six - Paclitaxel 175 mg/m2 iv; Carboplatin AUC 6 iv; Avastin 15 mg/kg IV Repeat cycle every 21 days, total of 6 cycles
480873|NCT00407966|B1|Baseline|Arm A|Flavopiridol, ara-C, mitoxantrone
480874|NCT00407966|P1|Participant Flow|Arm A|Flavopiridol, ara-C, mitoxantrone
480875|NCT00407966|O1|Outcome|Arm A|Flavopiridol, ara-C, mitoxantrone
480876|NCT00407966|E1|Reported Event|Arm A|Flavopiridol, ara-C, mitoxantrone
480877|NCT00407797|B1|Baseline|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
480878|NCT00407797|P1|Participant Flow|Pregabalin|150 mg per day as two doses (75 mg twice daily; BID), increased to 600 mg per day (300 mg BID) as needed based on response and tolerability
480879|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480880|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480881|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480882|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480883|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480884|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
481296|NCT00406653|E6|Reported Event|Placebo (IP)|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
480889|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480890|NCT00407797|O1|Outcome|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480891|NCT00407797|E1|Reported Event|Pregabalin|75 mg BID (twice daily); may have been increased to 150 mg BID after Week 1, and to 300 mg BID after Week 2 based on response and tolerability
480892|NCT00407745|B3|Baseline|Total|Total of all reporting groups
480893|NCT00407745|B2|Baseline|Placebo|Placebo matching study treatment.
480894|NCT00407745|B1|Baseline|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480895|NCT00407745|P2|Participant Flow|Placebo|Placebo matching study treatment.
480896|NCT00407745|P1|Participant Flow|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480897|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480898|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480899|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480900|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480901|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480902|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480903|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480904|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480905|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480906|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480907|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480908|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480909|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480910|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480911|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480973|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
480912|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480913|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480914|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480915|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480916|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480917|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480918|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480919|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480920|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480921|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480922|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480923|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480924|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480925|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480926|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480927|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480928|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480929|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480930|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480931|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480974|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
482043|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
480932|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480933|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480934|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480935|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480936|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480937|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480938|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480939|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480940|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480941|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480942|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480943|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480944|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480945|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480946|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480947|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480948|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480949|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480950|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480951|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480975|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
480952|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480953|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480954|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480955|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480956|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480957|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480958|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480959|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480960|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480961|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480962|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480963|NCT00407745|O2|Outcome|Placebo|Placebo matching study treatment.
480964|NCT00407745|O1|Outcome|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480965|NCT00407745|E2|Reported Event|Placebo|Placebo matching study treatment.
480966|NCT00407745|E1|Reported Event|Pregabalin|Pregabalin 75 milligram (mg) capsule administered by mouth (PO) twice daily (BID) for 7 days. On Day 8, dose may have been maintained at 150 mg per day or increased to 300 mg per day. Each week thereafter, including at Visit 4, a dose increase or decrease may have occurred depending on clinical judgement on adequate pain relief and tolerability. Following the end of adjustment phase, at Visit 4, participants were at their optimized dose (150 mg per day, 300 mg per day, 450 mg per day, or 600 mg per day). Participants remained at this maintenance dose throughout the next 12 weeks of the study.
480967|NCT00407654|B1|Baseline|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
480968|NCT00407654|P1|Participant Flow|VEGF Trap IV Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
480969|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
480970|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
480971|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
480972|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
481008|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
480976|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap (aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~aflibercept: Given intravenously"
480977|NCT00407654|O1|Outcome|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given intravenously~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
480978|NCT00407654|E1|Reported Event|Arm I|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
480979|NCT00407563|B1|Baseline|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480980|NCT00407563|P1|Participant Flow|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480981|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480982|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480983|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480984|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480985|NCT00407563|O1|Outcome|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480986|NCT00407563|E1|Reported Event|Bevacizumab and Abraxane|All subjects received treatment with bevacizumab and Abraxane. Bevacizumab will be given via IV infusion at 10 mg/kg given on days 1 and 15 of a 28-day cycle. Abraxane will be given via IV infusion at 100 mg/m^2 over 30 minutes on days 1, 8, and 15 of a 28-day cycle.
480987|NCT00407550|B3|Baseline|Total|Total of all reporting groups
480988|NCT00407550|B2|Baseline|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
480989|NCT00407550|B1|Baseline|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
480990|NCT00407550|P2|Participant Flow|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
480991|NCT00407550|P1|Participant Flow|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
480992|NCT00407550|O2|Outcome|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
480993|NCT00407550|O1|Outcome|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
480994|NCT00407550|E2|Reported Event|Gemzar x1|Treat subjects with 1 dosing/cycle of Gemzar x9 cycles.
480995|NCT00407550|E1|Reported Event|Gemzar x2|Treat subjects with 2 dosings/cycle of Gemzar x6 cycles.
480996|NCT00407537|B3|Baseline|Total|Total of all reporting groups
480997|NCT00407537|B2|Baseline|Usual Care as Assigned|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
480998|NCT00407537|B1|Baseline|Caduet as Assigned|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
480999|NCT00407537|P2|Participant Flow|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481000|NCT00407537|P1|Participant Flow|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481001|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481002|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481003|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481004|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481005|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481006|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481007|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481214|NCT00406653|B4|Baseline|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481009|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481010|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481011|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481012|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481013|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481014|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481015|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481016|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481017|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481018|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481019|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481020|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481021|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481022|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481023|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481024|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481025|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481026|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481027|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481028|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481029|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481030|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481031|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481032|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481033|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481034|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481035|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481036|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481037|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481038|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481215|NCT00406653|B3|Baseline|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
481039|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481040|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481041|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481042|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481043|NCT00407537|O2|Outcome|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481044|NCT00407537|O1|Outcome|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481045|NCT00407537|E2|Reported Event|Usual Care|Full choice of any locally approved (and not contra indicated) anti-hypertensive and/or lipid lowering drugs, including, but not limited to amlodipine and atorvastatin, according to local clinical practice.
481046|NCT00407537|E1|Reported Event|Caduet|Open label amlodipine besylate/atorvastatin calcium (Caduet) single pill combination at multiple doses: 5/10, 10/10, 5/20, 10/20 mg prescribed at the investigator's discretion.
481047|NCT00407511|B1|Baseline|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481048|NCT00407511|P1|Participant Flow|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481049|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481050|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481051|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481052|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481053|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481054|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481055|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481056|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481216|NCT00406653|B2|Baseline|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
482403|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
481057|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481058|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481059|NCT00407511|O1|Outcome|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481060|NCT00407511|E1|Reported Event|Pregabalin|Dose adjustment phase: Week 1: 75mg BID (150 mg/day) all subjects; Week 2 through Week 4: subjects were assessed on a weekly basis for dose adjustment from 75 mg BID (150 mg/day) to 150 mg BID (300 mg/day), and to 300 mg BID (600 mg/day) if needed based on pain relief and tolerability. 8 week dose maintenance phase (Week 5 to Week 12): subjects continued with their final pregabalin dosage: 75mg BID (150 mg/day) to 300 mg BID (600 mg/day) based on individual pain response and tolerability.
481061|NCT00407485|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
481062|NCT00407485|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
481063|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
481064|NCT00407485|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
481065|NCT00407485|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive 4 mg/kg VEGF Trap IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~pharmacological study: Correlative studies"
481066|NCT00407355|B3|Baseline|Total|Total of all reporting groups
481067|NCT00407355|B2|Baseline|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481068|NCT00407355|B1|Baseline|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481069|NCT00407355|P2|Participant Flow|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481070|NCT00407355|P1|Participant Flow|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481071|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481072|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481073|NCT00407355|O2|Outcome|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481074|NCT00407355|O1|Outcome|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481075|NCT00407355|E2|Reported Event|BRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481076|NCT00407355|E1|Reported Event|CRVO|10 patients- RBZ dose level .5 for ITV injection given monthly for 3 months, then prn until 6 years 10 patients- RBZ dose level .3 for ITV injection given monthly for 3 months, then .5 prn until 6 years
481077|NCT00407030|B4|Baseline|Total|Total of all reporting groups
481078|NCT00407030|B3|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481079|NCT00407030|B2|Baseline|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481080|NCT00407030|B1|Baseline|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481222|NCT00406653|P3|Participant Flow|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
481081|NCT00407030|P3|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481082|NCT00407030|P2|Participant Flow|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481083|NCT00407030|P1|Participant Flow|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481084|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481085|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481086|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481087|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481088|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481089|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481090|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481091|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481092|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481093|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481094|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481095|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481096|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481097|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481098|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481099|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481100|NCT00407030|O3|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481101|NCT00407030|O2|Outcome|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481220|NCT00406653|P5|Participant Flow|ABA ~10 mg/kg, Maintenance Period (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481102|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481103|NCT00407030|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481104|NCT00407030|O1|Outcome|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481105|NCT00407030|E3|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl; Mode of administration: intramuscular injection
481106|NCT00407030|E2|Reported Event|incobotulinumtoxinA (Xeomin) (120 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 120 units; Mode of administration: intramuscular injection"
481107|NCT00407030|E1|Reported Event|incobotulinumtoxinA (Xeomin) (240 Units)|"incobotulinumtoxinA (Xeomin, also known as NT 201 or Botulinum toxin type A (150 kD), free from complexing proteins)(active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection, 240 units; Mode of administration: intramuscular injection"
481108|NCT00406848|B3|Baseline|Total|Total of all reporting groups
481109|NCT00406848|B2|Baseline|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481110|NCT00406848|B1|Baseline|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481111|NCT00406848|P2|Participant Flow|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481112|NCT00406848|P1|Participant Flow|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481113|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481114|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481115|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481116|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481117|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481118|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481217|NCT00406653|B1|Baseline|ABA 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
482404|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
481119|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481120|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481121|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481122|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481123|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481124|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481125|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481126|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481127|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481128|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481129|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481130|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481131|NCT00406848|O3|Outcome|Placebo Rescue|Participants who were randomized to placebo at baseline and for whom rescue treatment was required during the continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally until completing or discontinuing from the study.
481132|NCT00406848|O2|Outcome|Placebo Non-rescue|Participants who were randomized to placebo at baseline and for whom treatment rescue was not required during continuation phase. Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which they continued to receive placebo until completing or discontinuing from the study.
481133|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
482405|NCT00402987|O4|Outcome|Placebo|
481134|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481135|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481136|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481137|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481138|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481139|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481140|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481141|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481142|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481143|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481144|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481145|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481146|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481147|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481148|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
482406|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
481149|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481150|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481151|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481152|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481153|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481154|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481155|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481156|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481157|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481158|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481159|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481160|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481161|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481162|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481163|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
482044|NCT00404547|O2|Outcome|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
481164|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481165|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481166|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481167|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481168|NCT00406848|O2|Outcome|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity.
481169|NCT00406848|O1|Outcome|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481170|NCT00406848|E3|Reported Event|Rescued Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants were rescued to duloxetine 60 milligrams (mg) orally once daily (QD) beginning with duloxetine 30 mg QD orally for one week followed by duloxetine 60 mg QD orally for the remainder of the study. Results are for the randomized placebo patients who were rescued to duloxetine and reported events while they were on duloxetine.
481171|NCT00406848|E2|Reported Event|Placebo|Participants received placebo for 13 weeks (The first week was placebo lead-in). This double-blind acute phase was followed by a double-blind 12 week continuation phase during which participants either remained on placebo or were eligible for receiving duloxetine 60 milligrams (mg) orally once daily (QD), beginning with duloxetine 30 mg QD orally for 1 week followed by duloxetine 60 mg QD orally for the remainder of the study based on depression symptom severity. Results are for the randomized placebo patients who reported events while they were on placebo.
481172|NCT00406848|E1|Reported Event|Duloxetine|Participants received placebo for 1 week (double-blind placebo lead-in) then started with duloxetine 30 milligrams (mg) orally once daily (QD) for 1 week, followed by duloxetine 60 mg QD orally for 11 weeks. This double-blind acute treatment phase was followed by a double-blind 12 week continuation phase during which participants either remained on 60 mg QD or were eligible for dose escalation to 120 mg QD orally based on depression symptom severity.
481173|NCT00406783|B3|Baseline|Total|Total of all reporting groups
481174|NCT00406783|B2|Baseline|Placebo Tablet|placebo tablet, once daily for 15 days
481175|NCT00406783|B1|Baseline|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481176|NCT00406783|P2|Participant Flow|Placebo Tablet|placebo tablet, once daily for 15 days
481177|NCT00406783|P1|Participant Flow|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481178|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
481179|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481180|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
481181|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481182|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
481183|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481184|NCT00406783|O2|Outcome|Placebo Tablet|placebo tablet, once daily for 15 days
481185|NCT00406783|O1|Outcome|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481186|NCT00406783|E2|Reported Event|Placebo Tablet|placebo tablet, once daily for 15 days
481187|NCT00406783|E1|Reported Event|5-mg Desloratadine Tablet|5 mg desloratadine tablet, once daily for 15 days
481188|NCT00406718|B4|Baseline|Total|Total of all reporting groups
481189|NCT00406718|B3|Baseline|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481190|NCT00406718|B2|Baseline|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481218|NCT00406653|P7|Participant Flow|ABA ~10 mg/kg, Open-Label Period (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
482045|NCT00404547|O1|Outcome|Alvesco|320 mcg/day or 640 mcg/day
481191|NCT00406718|B1|Baseline|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
481192|NCT00406718|P3|Participant Flow|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481193|NCT00406718|P2|Participant Flow|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481194|NCT00406718|P1|Participant Flow|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
481195|NCT00406718|O3|Outcome|Treatment as Usual|"standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481196|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481197|NCT00406718|O1|Outcome|Pharm CAT|Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager.
481198|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481199|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481200|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
481201|NCT00406718|O3|Outcome|Standard|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481202|NCT00406718|O2|Outcome|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481203|NCT00406718|O1|Outcome|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
481204|NCT00406718|E3|Reported Event|Standard Treatment|"Participants will receive standard treatment~Standard treatment: Participants receiving standard treatment will keep the Med-eMonitor™ device in their homes throughout the study but will not use its medication reminder function."
481205|NCT00406718|E2|Reported Event|Med-eMonitor|"Participants will receive the Med-eMonitor™~Med-eMonitor Device: Participants will use the Med-eMonitor™ device, which is an electronic device that holds up to one month's supply of up to five medications. It is capable of cueing the taking of medication, warning patients when they are taking the wrong medication or taking it at the wrong time, recording side effect complaints, and through modem hookup promptly alerting treatment staff of failures to take medication as prescribed."
481206|NCT00406718|E1|Reported Event|PharmCAT|"Participants will receive PharmCAT~PharmCAT Therapy: Pharm CAT is a psychosocial intervention using environmental supports such as signs, alarms, checklists, and special medication containers to cue and sequence adaptive behavior in the patient's home environment. This treatment specifically targets adherence to medication, medication education, and orientation for patients with schizophrenia. Participants will receive weekly home visits from a case manager."
481207|NCT00406692|B1|Baseline|Zonisamide|400 mg daily
481208|NCT00406692|P1|Participant Flow|Zonisamide|400 mg daily
481209|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
481210|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
481211|NCT00406692|O1|Outcome|Zonisamide|400 mg daily
481212|NCT00406692|E1|Reported Event|Zonisamide|400 mg daily
481213|NCT00406653|B5|Baseline|Total|Total of all reporting groups
481223|NCT00406653|P2|Participant Flow|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
481224|NCT00406653|P1|Participant Flow|Abatacept (ABA) 30/~10 mg/kg, Induction Period (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481225|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481226|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481227|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481228|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481229|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481230|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481231|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481232|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481233|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481234|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481235|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481236|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481237|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481238|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481239|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481240|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481241|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481242|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481243|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481244|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481245|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481246|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481247|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481248|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481249|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481250|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481251|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481252|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481253|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481254|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481255|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481256|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481257|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481258|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481259|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481260|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481261|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481262|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481295|NCT00406653|E7|Reported Event|Placebo (MP)|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481263|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481264|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481265|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481266|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481267|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481268|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481269|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481270|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481271|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481272|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481273|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481274|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481275|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481276|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481277|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481278|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481279|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481280|NCT00406653|O4|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481281|NCT00406653|O3|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481282|NCT00406653|O2|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481283|NCT00406653|O1|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481284|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481285|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481286|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481287|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481288|NCT00406653|O1|Outcome|ABA ~10 mg/kg, OL|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481289|NCT00406653|O2|Outcome|Placebo, MP|During MP, placebo was administered IV at 28-day intervals starting on Day MP-1.
481290|NCT00406653|O1|Outcome|ABA ~10 mg/kg, MP|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481291|NCT00406653|O4|Outcome|Placebo, IP|During the IP, placebo was administered IV on Days IP-1, IP-15, IP-29, and IP-57.
481292|NCT00406653|O3|Outcome|ABA 3 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of 3 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of 3 mg/kg (3 mg/kg group).
481293|NCT00406653|O2|Outcome|ABA ~10 mg/kg, IP|During IP, abatacept administered IV on Days IP-1 and IP-15 at a dose of ~10 mg/kg (weight-tiered). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (weight-tiered; ~10 mg/kg group).
481294|NCT00406653|O1|Outcome|ABA 30/~10 mg/kg, IP|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
482046|NCT00404547|E2|Reported Event|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
481297|NCT00406653|E5|Reported Event|ABA ~10mg/kg (OL)|During OL, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day OL-1.
481298|NCT00406653|E4|Reported Event|ABA ~10mg/kg (MP)|During MP, abatacept administered IV at a dose of ~10 mg/kg (weight-tiered dosing) every 28 days starting Day MP-1.
481299|NCT00406653|E3|Reported Event|ABA ~10mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of ~10 mg/kg (weight-tiered).
481300|NCT00406653|E2|Reported Event|ABA 3mg/kg (IP)|During IP, abatacept administered IV on Days IP-1, IP-15, IP-29, and IP-57 at a dose of 3 mg/kg (fixed dose).
481301|NCT00406653|E1|Reported Event|ABA 30/~10mg/kg (IP)|During IP, abatacept administered intravenously (IV) on Days IP-1 and IP-15 at a dose of 30 mg/kg (fixed dose). On Days IP-29 and IP-57, abatacept was administered IV at a dose of ~10 mg/kg (10 mg/kg group).
481302|NCT00406640|B3|Baseline|Total|Total of all reporting groups
481303|NCT00406640|B2|Baseline|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481304|NCT00406640|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481305|NCT00406640|P2|Participant Flow|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481306|NCT00406640|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481307|NCT00406640|O2|Outcome|Escitalopram (ESC)|Taper Phase Day 239 or at discontinuation: If patients taking escitalopram 20 mg/day, then decrease to 10 mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10 mg/day decreased to matching escitalopram placebo/day for 7 days.
481308|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481309|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
481310|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
481311|NCT00406640|O2|Outcome|ESC Non-Responders / DVS SR OL|Patients who received ESC during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
481312|NCT00406640|O1|Outcome|DVS SR Non-Responders / DVS SR OL|Patients who received DVS SR during the acute double blind phase (weeks 1-8), did not achieve a response to treatment (response defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase; entered into open label (OL) treatment with DVS SR during 6-month Open Label Extension phase.
481313|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
481314|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
481315|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
481316|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
481317|NCT00406640|O2|Outcome|ESC Responders / ESC DB|Patients who received ESC during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on ESC during the 6-month Double Blind Continuation phase.
481318|NCT00406640|O1|Outcome|DVS SR Responders / DVS SR DB|Patients who received DVS SR during the acute double blind phase (weeks 1-8), achieved a response to treatment (defined as HAM-D17 improved ≥50% from baseline) at the end of the acute phase and continued on DVS SR during the 6-month Double Blind Continuation phase.
481319|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481320|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481321|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481322|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481323|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481324|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481371|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481372|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481416|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481325|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481326|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481327|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481328|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481329|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481330|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481331|NCT00406640|O2|Outcome|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481332|NCT00406640|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481413|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481333|NCT00406640|E2|Reported Event|Escitalopram|Acute DB Phase Days 1-14:escitalopram 10mg/day; Days 15-56:discretion of the investigator patients assigned escitalopram 10mg/day or 20mg/day 6-Month Continuation Phases DB Continuation Phase for Responders (HAM-D17 improved 50% from baseline) Days 57-238:continue taking escitalopram 10mg/day or 20mg/day OL Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63:DVS SR 100mg/day; Days 64-238:At the discretion of the investigator, patients assigned DVS SR 100mg/day or 200mg/day Taper Phase Day 239 or at discontinuation:If patient taking DVS SR 200mg/day, decreased to 100mg/day for 7 days, and then decreased to 50mg/day for 7 days. Patients taking DVS SR 100mg/day decreased to 50mg/day for 7 days. If patients taking escitalopram 20mg/day, decreased to 10mg/day for 7 days and then decreased to matching escitalopram placebo/day for 7 days. Patients taking escitalopram 10mg/day decreased to matching escitalopram placebo/day for 7 days.
481334|NCT00406640|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR)|Acute Double Blind (DB) Phase Days 1 to 7: DVS SR 50 mg/day Days 8 to 14: 100 mg/day Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day or 200 mg/day 6-Month Continuation Phases Double Blind Continuation Phase for Responders (HAM-D17 improved ≥50% from baseline) Days 57-238: continue taking DVS SR 100 mg/day or 200 mg/day Open-Label (OL) Extension Phase for Non-Responders (HAM-D17 improved <50% from baseline) Days 57-63: DVS SR 100 mg/day Days 64-238: At the discretion of the investigator, patients assigned DVS SR 100 mg/day or 200mg/day Taper Phase Day 239 or at discontinuation: If patient taking DVS SR 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking DVS SR 100 mg/day decreased to 50 mg/day for 7 days.
481335|NCT00406393|B3|Baseline|Total|Total of all reporting groups
481336|NCT00406393|B2|Baseline|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481337|NCT00406393|B1|Baseline|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481338|NCT00406393|P2|Participant Flow|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481339|NCT00406393|P1|Participant Flow|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481340|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481341|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481342|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481343|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481344|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481345|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481346|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481347|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481348|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481349|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481350|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481351|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481352|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481353|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481354|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481355|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481356|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481357|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481358|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481359|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481360|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481361|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481362|NCT00406393|O2|Outcome|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481363|NCT00406393|O1|Outcome|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481364|NCT00406393|E2|Reported Event|Tacrolimus/Methotrexate|Patients will be given Tacrolimus and Methotrexate for GVHD prophylaxis.
481365|NCT00406393|E1|Reported Event|Tacrolimus/Sirolimus|Patients will be given Tacrolimus and Sirolimus for GVHD prophylaxis.
481366|NCT00406367|B3|Baseline|Total|Total of all reporting groups
481367|NCT00406367|B2|Baseline|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481368|NCT00406367|B1|Baseline|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481369|NCT00406367|P2|Participant Flow|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481370|NCT00406367|P1|Participant Flow|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481414|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481373|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481374|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481375|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481376|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481377|NCT00406367|O2|Outcome|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481378|NCT00406367|O1|Outcome|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481379|NCT00406367|E2|Reported Event|Placebo|Placebo to incobotulinumtoxinA (Xeomin) powder for solution for injection Dose (Main Period only): one injection session of solution, prepared by reconstitution of powder with 0.9% NaCl;Mode of administration: intramuscular injection
481380|NCT00406367|E1|Reported Event|incobotulinumtoxinA (Xeomin)|incobotulinumtoxinA (Xeomin) (active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins) powder for solution for injection
481381|NCT00406354|B4|Baseline|Total|Total of all reporting groups
481382|NCT00406354|B3|Baseline|Placebo|matching placebo daily dose taken orally
481383|NCT00406354|B2|Baseline|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481384|NCT00406354|B1|Baseline|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481385|NCT00406354|P3|Participant Flow|Placebo|matching placebo daily dose taken orally
481386|NCT00406354|P2|Participant Flow|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481387|NCT00406354|P1|Participant Flow|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481388|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481389|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481390|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481391|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481392|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481393|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481394|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481395|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481396|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481397|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481398|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481399|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481400|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481401|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481402|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481403|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481404|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481405|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481406|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481407|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481408|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481409|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481410|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481411|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481412|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481415|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
482047|NCT00404547|E1|Reported Event|Alvesco|320 mcg/day or 640 mcg/day
481417|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481418|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481419|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481420|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481421|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481422|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481423|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481424|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481425|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481426|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481427|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481428|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481429|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481430|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481431|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481432|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481433|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481434|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481435|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481436|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481437|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481438|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481439|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481440|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481441|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481442|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481443|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481444|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481445|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481446|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481447|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481448|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481449|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481450|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481451|NCT00406354|O3|Outcome|Placebo|matching placebo daily dose taken orally
481452|NCT00406354|O2|Outcome|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481453|NCT00406354|O1|Outcome|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481454|NCT00406354|E3|Reported Event|Placebo|matching placebo daily dose taken orally
481455|NCT00406354|E2|Reported Event|Atomoxetine Slow Titration|0.5 mg/kg daily dose taken orally for 1 week, then 0.8 mg/kg daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 7 weeks
481456|NCT00406354|E1|Reported Event|Atomoxetine Fast Titration|0.5 milligram per kilogram (mg/kg) daily dose taken orally for 1 week, then 1.2 mg/kg daily dose taken orally for 8 weeks
481457|NCT00406315|B1|Baseline|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481518|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
482048|NCT00404495|B3|Baseline|Total|Total of all reporting groups
481458|NCT00406315|P1|Participant Flow|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481459|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481460|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481461|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481462|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481463|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481464|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481465|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481466|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481467|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481468|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481469|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481470|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481471|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481472|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481519|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481520|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
482407|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
481473|NCT00406315|O1|Outcome|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481474|NCT00406315|E1|Reported Event|Ziprasidone|For Days 1 to 3, the subject was dosed at 40 mg twice a day (BID) (80 mg/day), taking two 20 mg capsules BID. For Days 4 to 7, the subject was dosed at 60 mg BID (120 mg/day), taking one 60 mg capsule BID. On Day 8, the subject was dosed at 80 mg BID (160 mg/day), taking one 20 mg capsule and one 60 mg capsule BID. Based on clinical judgment, the dose could have been adjusted once per week in increments/decrements of up to 40 mg daily.
481475|NCT00406276|B1|Baseline|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
481476|NCT00406276|P1|Participant Flow|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
481477|NCT00406276|O1|Outcome|Docetaxel/RAD001|
481478|NCT00406276|O1|Outcome|Docetaxel/RAD001|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
481479|NCT00406276|E1|Reported Event|RAD001+Docetaxel|Docetaxel 60 mg/m^2 given intravenously over 60 minutes on day 1 of each cycle. RAD 001 5 mg by mouth once a day on days 1-19 of each cycle.
481480|NCT00406133|B5|Baseline|Total|Total of all reporting groups
481481|NCT00406133|B4|Baseline|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
481482|NCT00406133|B3|Baseline|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
481483|NCT00406133|B2|Baseline|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
481484|NCT00406133|B1|Baseline|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
481485|NCT00406133|P4|Participant Flow|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
481486|NCT00406133|P3|Participant Flow|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
481487|NCT00406133|P2|Participant Flow|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
481488|NCT00406133|P1|Participant Flow|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
481489|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481490|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481491|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481492|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481493|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481494|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481495|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481496|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481497|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481498|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481499|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HBA1c >=7.0% who were randomized to standard care
481500|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481501|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481502|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481503|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481504|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481505|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481506|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481507|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481508|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481509|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481510|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481511|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481512|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481513|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481514|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481515|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481516|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481517|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
482408|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
481521|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481522|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481523|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481524|NCT00406133|O1|Outcome|Primary Cohort RT-CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481525|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481526|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481527|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481528|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481529|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481530|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481531|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481532|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481533|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c <7.0% who were randomized to standard care
481534|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c <7.0% who were randomized to CGM use
481535|NCT00406133|O2|Outcome|Primary Cohort Control Group|Participants with baseline HbA1c >=7.0% who were randomized to standard care
481536|NCT00406133|O1|Outcome|Primary Cohort CGM Group|Participants with baseline HbA1c >=7.0% who were randomized to CGM use
481537|NCT00406133|E4|Reported Event|Secondary Cohort Control Group|Participants with baseline A1c <7.0% who were randomized to standard care
481538|NCT00406133|E3|Reported Event|Secondary Cohort RT-CGM Group|Participants with baseline A1c <7.0% who were randomized to CGM use
481539|NCT00406133|E2|Reported Event|Primary Cohort Control Group|Participants with baseline A1c >=7.0% who were randomized to standard care
481540|NCT00406133|E1|Reported Event|Primary Cohort RT-CGM Group|Participants with baseline A1c >=7.0% who were randomized to CGM use
481541|NCT00406107|B3|Baseline|Total|Total of all reporting groups
481542|NCT00406107|B2|Baseline|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
481543|NCT00406107|B1|Baseline|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
481544|NCT00406107|P2|Participant Flow|Pegaptanib Sodium 1 mg (Macugen)|
481545|NCT00406107|P1|Participant Flow|Pegaptanib Sodium 0.3mg (Macugen)|
481546|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
481547|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
481548|NCT00406107|O2|Outcome|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
481549|NCT00406107|O1|Outcome|Pegaptanib Sodium 0.3mg (Macugen)|Patients experiencing an ocular adverse event, in this case a retinal detachment
481550|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
481551|NCT00406107|O1|Outcome|All Study Participants|Outcome measures were assessed without regard to dosage of pegaptanib received
481552|NCT00406107|E2|Reported Event|Pegaptanib Sodium 1 mg (Macugen)|Intravitreous injections of Macugen 1.0mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
481553|NCT00406107|E1|Reported Event|Pegaptanib Sodium 0.3mg (Macugen)|Intravitreous injections of Macugen 0.3mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
481554|NCT00406029|B6|Baseline|Total|Total of all reporting groups
481555|NCT00406029|B5|Baseline|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481556|NCT00406029|B4|Baseline|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481557|NCT00406029|B3|Baseline|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481558|NCT00406029|B2|Baseline|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481559|NCT00406029|B1|Baseline|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481560|NCT00406029|P5|Participant Flow|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481561|NCT00406029|P4|Participant Flow|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481562|NCT00406029|P3|Participant Flow|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481563|NCT00406029|P2|Participant Flow|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481564|NCT00406029|P1|Participant Flow|Preladenant 1 mg BID|Participants received preladenant 1 mg twice daily (BID) during the 12-week treatment period.
481565|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481566|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481567|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
482409|NCT00402987|O3|Outcome|Placebo|
481568|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481569|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481570|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481571|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481572|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481573|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481574|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481575|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481576|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481577|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481578|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481579|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481580|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481581|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481582|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481583|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481584|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481585|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481586|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481587|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481588|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481589|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481590|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481591|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481592|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481593|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481594|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481595|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481596|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481597|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481598|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481599|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481600|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481601|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481602|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481603|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481604|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481605|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481606|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481607|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481608|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481609|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481610|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481611|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481612|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481613|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481614|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481615|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481616|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481617|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481618|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481619|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481620|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481621|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481622|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481623|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481624|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481625|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481626|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481627|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481628|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481629|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481630|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481631|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481632|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481633|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481634|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481635|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481636|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481637|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481638|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481639|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481640|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481641|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481642|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481643|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481644|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481645|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481646|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481647|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481648|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481649|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481650|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481651|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481652|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481653|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481654|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481655|NCT00406029|O5|Outcome|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481656|NCT00406029|O4|Outcome|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481657|NCT00406029|O3|Outcome|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481658|NCT00406029|O2|Outcome|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481659|NCT00406029|O1|Outcome|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481660|NCT00406029|E5|Reported Event|Placebo BID|Participants received preladenant matching placebo BID during the 12-week treatment period.
481661|NCT00406029|E4|Reported Event|Preladenant 10 mg BID|Participants received preladenant 10 mg BID during the 12-week treatment period.
481662|NCT00406029|E3|Reported Event|Preladenant 5 mg BID|Participants received preladenant 5 mg BID during the 12-week treatment period.
481663|NCT00406029|E2|Reported Event|Preladenant 2 mg BID|Participants received preladenant 2 mg BID during the 12-week treatment period.
481664|NCT00406029|E1|Reported Event|Preladenant 1 mg BID|Participants received preladenant 1 mg BID during the 12-week treatment period.
481665|NCT00405964|B3|Baseline|Total|Total of all reporting groups
481666|NCT00405964|B2|Baseline|Placebo Tablet|Matching placebo, orally daily.
481667|NCT00405964|B1|Baseline|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481668|NCT00405964|P2|Participant Flow|Placebo Tablet|Matching placebo, orally daily.
481669|NCT00405964|P1|Participant Flow|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481670|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
481671|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481672|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
481673|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481674|NCT00405964|O2|Outcome|Placebo Tablet|Matching placebo, orally daily.
481675|NCT00405964|O1|Outcome|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481676|NCT00405964|E2|Reported Event|Placebo Tablet|Matching placebo, orally daily.
481677|NCT00405964|E1|Reported Event|5-mg Desloratadine Tablet|Desloratadine 5 mg orally daily. Dosing was to be in the morning (AM) within 1 hour of awakening.
481678|NCT00405938|B3|Baseline|Total|Total of all reporting groups
481679|NCT00405938|B2|Baseline|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
481680|NCT00405938|B1|Baseline|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
481681|NCT00405938|P2|Participant Flow|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
481682|NCT00405938|P1|Participant Flow|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
481683|NCT00405938|O2|Outcome|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
481684|NCT00405938|O1|Outcome|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
481685|NCT00405938|E2|Reported Event|Bevacizumab/Fulvestrant|Bevacizumab/fulvestrant (with trastuzumab in HER2+ patients). Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] fulvestrant (500 mg intramuscular on Day 1 of Cycle 1, followed by 250 mg intramuscular of fulvestrant on Day 15 of Cycle 1. On Day 1 of Cycle 2 and the first day of all subsequent cycles thereafter, patients in this treatment arm will receive 250 mg intramuscular of fulvestrant). Treatment will be given in 4-week cycles.
481686|NCT00405938|E1|Reported Event|Bevacizumab/Anastrozole|Bevacizumab 10mg/kg IV every 2 weeks [patients who are also receiving trastuzumab have the option to receive their bevacizumab at 15 mg/kg every 3 weeks instead of 10 mg/kg every 2 weeks (see Trastuzumab section below)] and anastrozole (1 mg orally daily). Treatment will be given in 4-week cycles.
481687|NCT00405912|B4|Baseline|Total|Total of all reporting groups
481688|NCT00405912|B3|Baseline|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
481689|NCT00405912|B2|Baseline|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
481690|NCT00405912|B1|Baseline|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
481691|NCT00405912|P3|Participant Flow|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
481692|NCT00405912|P2|Participant Flow|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
481693|NCT00405912|P1|Participant Flow|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
481694|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
481695|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
481696|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
481697|NCT00405912|O3|Outcome|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
481698|NCT00405912|O2|Outcome|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
481699|NCT00405912|O1|Outcome|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
481700|NCT00405912|E3|Reported Event|St. John's Wort - 1800 mg /Day|St. John’s Wort was initiated at a dose of 300 mg by mouth three times a day. The dose was increased after the first week to the target doses of 600 mg three times a day. This dose was continued for the next 11 weeks. The medication was stopped at the end of 12 weeks.
481701|NCT00405912|E2|Reported Event|St. John's Wort - 900 mg /Day|St. John's Wort at a dose of 300 mg by mouth three times per day. The medication was stopped at the end of 12 weeks.
481702|NCT00405912|E1|Reported Event|Placebo|The placebo pill was identical in appearance to the active medication. Dosage consisted of 1 pill by mouth three times per day. The medication was stopped at the end of 12 weeks.
481703|NCT00405821|B3|Baseline|Total|Total of all reporting groups
481704|NCT00405821|B2|Baseline|Placebo Tablet Twice Daily|
481705|NCT00405821|B1|Baseline|Acyclovir 400mg Tablet Twice Daily|
481706|NCT00405821|P2|Participant Flow|Placebo Tablet Twice Daily|
481707|NCT00405821|P1|Participant Flow|Acyclovir 400mg Tablet Twice Daily|
481708|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
481709|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
481710|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
481711|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
481712|NCT00405821|O2|Outcome|Placebo Tablet Twice Daily|
481713|NCT00405821|O1|Outcome|Acyclovir 400mg Tablet Twice Daily|
481714|NCT00405821|E2|Reported Event|Placebo Tablet Twice Daily|
481715|NCT00405821|E1|Reported Event|Acyclovir 400mg Tablet Twice Daily|
481716|NCT00405756|B4|Baseline|Total|Total of all reporting groups
481717|NCT00405756|B3|Baseline|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481718|NCT00405756|B2|Baseline|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481719|NCT00405756|B1|Baseline|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481720|NCT00405756|P3|Participant Flow|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481721|NCT00405756|P2|Participant Flow|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481722|NCT00405756|P1|Participant Flow|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481723|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481724|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481725|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481726|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481727|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481728|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481729|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481819|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481730|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481731|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481732|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481733|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481734|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481735|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481736|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481737|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481738|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481739|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481740|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481741|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481742|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481743|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481744|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481745|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481746|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481747|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481748|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481749|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481750|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481820|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
482410|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
481751|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481752|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481753|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481754|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481755|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481756|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481757|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481758|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481759|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481760|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481761|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481762|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481763|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481764|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481765|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481766|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481767|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481768|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481769|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481770|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481771|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481869|NCT00405509|B1|Baseline|Confirmed Respiratory Infection|participants who had the type of viral infection confirmed by assay
481772|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481773|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481774|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481775|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481776|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481777|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481778|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481779|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481780|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481781|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481782|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481783|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481784|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481785|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481786|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481787|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481788|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481789|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481790|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481791|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481792|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481870|NCT00405509|P2|Participant Flow|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481793|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481794|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481795|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481796|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481797|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481798|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481799|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481800|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481801|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481802|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481803|NCT00405756|O3|Outcome|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481804|NCT00405756|O2|Outcome|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481805|NCT00405756|O1|Outcome|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481806|NCT00405756|E3|Reported Event|MPp+p|Double-blind induction therapy with melphalan/prednisone and placebo (MPp) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481807|NCT00405756|E2|Reported Event|MPR+p|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10mg (MPR) for up to 9 cycles, followed by maintenance therapy with placebo (p) from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481808|NCT00405756|E1|Reported Event|MPR+R|Double-blind induction therapy with melphalan/prednisone and lenalidomide 10 mg (MPR) for up to 9 cycles, followed by maintenance therapy with single-agent lenalidomide (R) 10mg from cycle 10 to disease progression. Optional open-label extension therapy with lenalidomide up to 25 mg for participants with progressive disease.
481809|NCT00405704|B3|Baseline|Total|Total of all reporting groups
481810|NCT00405704|B2|Baseline|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481811|NCT00405704|B1|Baseline|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481812|NCT00405704|P2|Participant Flow|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481813|NCT00405704|P1|Participant Flow|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481814|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481815|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481816|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481817|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481818|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481871|NCT00405509|P1|Participant Flow|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481821|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481822|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481823|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481824|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481825|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481826|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481827|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481828|NCT00405704|O2|Outcome|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481829|NCT00405704|O1|Outcome|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481830|NCT00405704|E2|Reported Event|Placebo|Placebo: Cherry flavored liquid suspension matched to active comparator.
481831|NCT00405704|E1|Reported Event|Trimethoprim-Sulfamethoxazole|Trimethoprim-Sulfamethoxazole: Cherry-flavored liquid suspension with 3 mg of trimethoprim plus 15 mg sulfamethoxazole per kilogram of body weight, taken once daily.
481832|NCT00405652|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
481833|NCT00405652|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
481834|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
481835|NCT00405652|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
481836|NCT00405652|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate sodium (EC-MPS), administered orally twice a day to achieve a dose equimolar to the dose of Mycophenolate mofetil (MMF) the patient was taking at the time of study entry up to a maximum dose of 1440 mg.
481837|NCT00405639|B3|Baseline|Total|Total of all reporting groups
481838|NCT00405639|B2|Baseline|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481839|NCT00405639|B1|Baseline|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481840|NCT00405639|P2|Participant Flow|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481841|NCT00405639|P1|Participant Flow|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481842|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481843|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481844|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481845|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481846|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481847|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481848|NCT00405639|O2|Outcome|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481849|NCT00405639|O1|Outcome|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481850|NCT00405639|E2|Reported Event|Placebo|Subjects randomized to this arm will receive self administered SQ placebo (normal saline) injections to match those of the study drug group. That is, first dose on Day 1, second dose 12 hours after the first dose, third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481851|NCT00405639|E1|Reported Event|Nesiritide|Subjects randomized to this arm will receive 5 microgram/Kg subcutaneous (SQ) injection of nesiritide on Day 1. If after the first SQ injection the subject's systolic blood pressure is >90 mmHG and no symptoms of hypotension, then the second dose can be increased to 10 microgram/Kg. Subjects will self-administer the second dose 12 hours after the first dose, then self-administer the third dose 12 hours after the second dose. Subjects will be dismissed with instructions and supplies for 6 weeks of SQ administration twice a day. After 6 weeks, the subjects will return to the lab for assessments, and will be dismissed with supplies for 6 more weeks of SQ administration twice a day.
481852|NCT00405548|B3|Baseline|Total|Total of all reporting groups
481853|NCT00405548|B2|Baseline|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481854|NCT00405548|B1|Baseline|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481855|NCT00405548|P2|Participant Flow|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481856|NCT00405548|P1|Participant Flow|BNP (Nesiritide)|Brain Natriuretic Peptide (BNP) 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481857|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481858|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481859|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481860|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481861|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481862|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481863|NCT00405548|O2|Outcome|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481864|NCT00405548|O1|Outcome|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481865|NCT00405548|E2|Reported Event|Placebo|Saline solution given subcutaneously twice per day for 12 weeks (packaged to match active comparator)
481866|NCT00405548|E1|Reported Event|BNP (Nesiritide)|BNP 10 micrograms/Kg twice per day given subcutaneously for 12 weeks
481867|NCT00405509|B3|Baseline|Total|Total of all reporting groups
481868|NCT00405509|B2|Baseline|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481872|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481873|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481874|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481875|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481876|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481877|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481878|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481879|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481880|NCT00405509|O2|Outcome|Unconfirmed Respiratory Infection|participants who were not positive for any of the tested viruses and thus viral infection type could not be confirmed
481881|NCT00405509|O1|Outcome|Confirmed Respiratory Infection|respiratory infection virus type confirmed by assay
481882|NCT00405509|E2|Reported Event|Unconfirmed Respiratory Infection|
481883|NCT00405509|E1|Reported Event|Confirmed Respiratory Virus|
481884|NCT00405288|B3|Baseline|Total|Total of all reporting groups
481885|NCT00405288|B2|Baseline|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481886|NCT00405288|B1|Baseline|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481887|NCT00405288|P2|Participant Flow|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481888|NCT00405288|P1|Participant Flow|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481889|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481890|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481891|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481892|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481893|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481894|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481895|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481896|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481897|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481898|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481899|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481900|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481901|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481902|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481903|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481904|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481905|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481906|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481907|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481908|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481909|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481910|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481911|NCT00405288|O2|Outcome|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481912|NCT00405288|O1|Outcome|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481913|NCT00405288|E2|Reported Event|Control|Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
481914|NCT00405288|E1|Reported Event|Proctofoam-HC®|Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
481915|NCT00405275|B3|Baseline|Total|Total of all reporting groups
481916|NCT00405275|B2|Baseline|Etanercept|Etanercept and Methotrexate
481917|NCT00405275|B1|Baseline|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
481918|NCT00405275|P2|Participant Flow|Etanercept|"Etanercept (50mg subcutaneous injections weekly); Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, triple: placebo hydroxychloroquine (tablets daily) and placebo sulfasalazine (tablets daily).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Triple. This is denoted in results table below as switch. No switch participants remained on Etanercept therapy throughout the trial."
481919|NCT00405275|P1|Participant Flow|Triple|"Hydroxychloroquine (400mg daily); Sulfasalazine (1g daily for 6 weeks, then increased to 2g daily; Methotrexate (maintaining baseline dose, 10-25mg weekly); Placebo, etanercept (subcutaneous injection).~Nonresponders (change in DAS28 < 1.2units at 24 weeks) were switched to Etanercept at 24 weeks. This is denoted in results table below as switch. No switch participants remained on Triple therapy throughout the trial."
481920|NCT00405275|O2|Outcome|Etanercept|Etanercept and Methotrexate
481921|NCT00405275|O1|Outcome|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
481922|NCT00405275|E2|Reported Event|Etanercept|Etanercept and Methotrexate
481923|NCT00405275|E1|Reported Event|Triple|Hydroxychloroquine, sulfasalazine and methotrexate
481924|NCT00405067|B4|Baseline|Total|Total of all reporting groups
481925|NCT00405067|B3|Baseline|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481926|NCT00405067|B2|Baseline|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481927|NCT00405067|B1|Baseline|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481928|NCT00405067|P3|Participant Flow|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481929|NCT00405067|P2|Participant Flow|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481930|NCT00405067|P1|Participant Flow|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481931|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481932|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481933|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481934|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481935|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481936|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481937|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481938|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481939|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481940|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481941|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481942|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481943|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481944|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481945|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481946|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481947|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481948|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481949|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481950|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481951|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481952|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481953|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481954|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481955|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481956|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481957|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481958|NCT00405067|O3|Outcome|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481959|NCT00405067|O2|Outcome|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481960|NCT00405067|O1|Outcome|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481961|NCT00405067|E3|Reported Event|Ezetimibe Monotherapy|Oral ezetimibe 10 mg and lomitapide placebo for 12 weeks.
481962|NCT00405067|E2|Reported Event|Lomitapide Monotherapy|Oral ezetimibe placebo and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481963|NCT00405067|E1|Reported Event|Combination Therapy|Oral ezetimibe 10 mg and lomitapide escalated with an initial oral dose of 5 mg for 4 weeks and then escalated through 2 additional dose levels (7.5 mg and 10 mg) every 4 weeks over an 8-week period.
481964|NCT00404924|B3|Baseline|Total|Total of all reporting groups
481965|NCT00404924|B2|Baseline|Placebo|Placebo plus best supportive care
481966|NCT00404924|B1|Baseline|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481967|NCT00404924|P2|Participant Flow|Placebo|Placebo plus best supportive care
481968|NCT00404924|P1|Participant Flow|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481969|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481970|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481971|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481972|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481973|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481974|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481975|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481976|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481977|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481978|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481979|NCT00404924|O2|Outcome|Placebo|Placebo plus best supportive care
481980|NCT00404924|O1|Outcome|Vandetanib 300 mg|vandetanib (300 mg daily) plus best supportive care
481981|NCT00404924|E2|Reported Event|Placebo|Placebo
481982|NCT00404924|E1|Reported Event|Vandetanib|Vandetanib 300 mg
481983|NCT00404820|B3|Baseline|Total|Total of all reporting groups
481984|NCT00404820|B2|Baseline|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481985|NCT00404820|B1|Baseline|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481986|NCT00404820|P2|Participant Flow|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481987|NCT00404820|P1|Participant Flow|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481988|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481989|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481990|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481991|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481992|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481993|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481994|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481995|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481996|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481997|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481998|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
481999|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
482037|NCT00404547|B3|Baseline|Total|Total of all reporting groups
482038|NCT00404547|B2|Baseline|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
482000|NCT00404820|O2|Outcome|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
482001|NCT00404820|O1|Outcome|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
482002|NCT00404820|E2|Reported Event|Alendronate 70 mg|Patients received an alendronate 70 mg tablet once weekly with 200 ml of tap water in the morning on an empty stomach at least 30 minutes before the first meal. Patients were to remain in an upright position for 30 minutes after swallowing the tablet. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
482003|NCT00404820|E1|Reported Event|Zoledronic Acid 5 mg|Patients received zoledronic acid 5 mg in 100 ml solution in a 15 minute intravenous (iv) infusion once per year. The peripheral iv infusion was preceded by and followed by a 10 ml normal saline flush of the intravenous line. In addition to study therapy, all participants received 1200 mg elemental calcium and 800 IU of vitamin D daily. Calcium and vitamin D were supplied in a chewable tablet that was to be taken twice daily.
482004|NCT00404651|B5|Baseline|Total|Total of all reporting groups
482005|NCT00404651|B4|Baseline|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482006|NCT00404651|B3|Baseline|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482007|NCT00404651|B2|Baseline|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482008|NCT00404651|B1|Baseline|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482009|NCT00404651|P4|Participant Flow|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482010|NCT00404651|P3|Participant Flow|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482011|NCT00404651|P2|Participant Flow|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482012|NCT00404651|P1|Participant Flow|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482013|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482014|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482015|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482016|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482017|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482039|NCT00404547|B1|Baseline|Alvesco|320 mcg/day or 640 mcg/day
482040|NCT00404547|P2|Participant Flow|Usual Asthma Care and Dosage|as chosen by the Primary Care Physician
482041|NCT00404547|P1|Participant Flow|Alvesco|320 mcg/day or 640 mcg/day
482018|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482019|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482020|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482021|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482022|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482023|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482024|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482025|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482026|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482027|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482028|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482029|NCT00404651|O4|Outcome|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482030|NCT00404651|O3|Outcome|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482031|NCT00404651|O2|Outcome|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482032|NCT00404651|O1|Outcome|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482033|NCT00404651|E4|Reported Event|Infanrix Hexa™|Participants received 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed (Infanrix hexa™), plus Haemophilus influenzae type b (Hib) vaccine conjugated to tetanus protein , with one dose each at 2, 4, and 6 months of age.
482034|NCT00404651|E3|Reported Event|DTaP-IPV-HB-PRP~T Batch 3|Participants received 3 doses of Batch 3 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482035|NCT00404651|E2|Reported Event|DTaP-IPV-HB-PRP~T Batch 2|Participants received 3 doses of Batch 2 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-HB-PRP~T), with one dose each at 2, 4, and 6 months of age.
482036|NCT00404651|E1|Reported Event|DTaP-IPV-HB-PRP~T Batch 1|Participants received 3 doses of Batch 1 of diphtheria (D), tetanus (T), pertussis (2 component acellular), recombinant hepatitis B Hansenula (Hep B) and poliomyelitis (IPV) vaccine adsorbed, and Haemophilus influenzae type b (Hib) vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 4, and 6 months of age.
482049|NCT00404495|B2|Baseline|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482050|NCT00404495|B1|Baseline|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482051|NCT00404495|P2|Participant Flow|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482052|NCT00404495|P1|Participant Flow|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482053|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482054|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482055|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482056|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482057|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482058|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482059|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482060|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482061|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482062|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482063|NCT00404495|O2|Outcome|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482064|NCT00404495|O1|Outcome|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482065|NCT00404495|E2|Reported Event|Temozolomide + Irinotecan for High-Grade Glioma|For participants with high-grade glioma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: 2 cycles as a window phase before starting standard therapy.
482066|NCT00404495|E1|Reported Event|Temozolomide + Irinotecan for Medulloblastoma|For participants with medulloblastoma: Irinotecan 10 mg/m^2/day on Days 1-5 and Days 8-12 in repeated 3-week cycles. Temozolomide 100-125 mg/m^2 daily on Days 1-5 in repeated 3-week cycles; treatment duration: up to 1 year or until progression.
482067|NCT00404352|B4|Baseline|Total|Total of all reporting groups
482068|NCT00404352|B3|Baseline|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482069|NCT00404352|B2|Baseline|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482070|NCT00404352|B1|Baseline|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
482411|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482071|NCT00404352|P9|Participant Flow|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482072|NCT00404352|P8|Participant Flow|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482073|NCT00404352|P7|Participant Flow|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482074|NCT00404352|P6|Participant Flow|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482075|NCT00404352|P5|Participant Flow|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482076|NCT00404352|P4|Participant Flow|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482077|NCT00404352|P3|Participant Flow|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482078|NCT00404352|P2|Participant Flow|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482079|NCT00404352|P1|Participant Flow|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
482080|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482081|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482082|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482083|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482084|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482085|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482209|NCT00403767|B1|Baseline|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
482412|NCT00402987|O4|Outcome|Placebo|
482086|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482087|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482088|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482089|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482090|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482091|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482092|NCT00404352|O3|Outcome|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482093|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482094|NCT00404352|O1|Outcome|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482095|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482096|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482097|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
482098|NCT00404352|O3|Outcome|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482099|NCT00404352|O2|Outcome|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482100|NCT00404352|O1|Outcome|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to clinically definite multiple sclerosis (CDMS) whichever occurs first.
482210|NCT00403767|P2|Participant Flow|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482413|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482101|NCT00404352|E9|Reported Event|Placebo/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received placebo in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482102|NCT00404352|E8|Reported Event|RNF 44 Mcg Once Weekly/RNF 44 Mcg Three Times Weekly (OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year OLE. Participants who had received RNF once weekly in the core REFLEX trial were re-titrated with a single dose of RNF injection subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482103|NCT00404352|E7|Reported Event|RNF 44Mcg Three Times Weekly/RNF 44Mcg Three Times Weekly(OLE)|Participants who were not converted to CDMS and completed 24 month core REFLEX trial were enrolled in a 1 year open label extension (OLE). Participants who had received RNF three times a week in the core REFLEX trial, were re-titrated with a single dose of RNF injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 36 months in this 12 months open label extension.
482104|NCT00404352|E6|Reported Event|Placebo/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482105|NCT00404352|E5|Reported Event|RNF 44 Mcg Once Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received OL study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482106|NCT00404352|E4|Reported Event|RNF 44 Mcg Three Times Weekly/OL RNF 44 Mcg Three Times Weekly|After having converted to CDMS, participants received open-label (OL) study treatment with RNF. Single dose of RNF injection administrated subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months.
482107|NCT00404352|E3|Reported Event|Placebo (DB Population)|Single dose of matching placebo administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482108|NCT00404352|E2|Reported Event|RNF 44 Mcg Once Weekly (DB Population)|Single dose of RNF injection administered subcutaneously once weekly plus 2 matching placebo doses at least 48 hours apart at a starting dose of 8.8 mcg for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482109|NCT00404352|E1|Reported Event|RNF 44 Mcg Three Times Weekly (Double Blind [DB] Population)|Single dose of fetal bovine serum [FBS]-free/human serum albumin [HSA]-free formulation of interferon [IFN]-beta-1a (RNF) injection administered subcutaneously three times weekly at least 48 hours apart at a starting dose of 8.8 microgram (mcg) for first 2 weeks followed by 22 mcg for next 2 weeks and finally 44 mcg until 24 months or until conversion to CDMS whichever occurs first.
482110|NCT00404248|B4|Baseline|Total|Total of all reporting groups
482111|NCT00404248|B3|Baseline|Arm 3 no Stratification (+EIASD or -EIASD)|"Subjects were not stratified by antiseizure drugs~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Only dose tested: 2200.~NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482112|NCT00404248|B2|Baseline|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482113|NCT00404248|B1|Baseline|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482114|NCT00404248|P9|Participant Flow|Arm 9 - Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day. New formulation TC6."
482115|NCT00404248|P8|Participant Flow|Arm 8 -EIASD Level 4|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482116|NCT00404248|P7|Participant Flow|Arm 7 -EIASD Level 3|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation. this Arm including pts treated at the new formulation TC6 at 1700mg~PK data will be collected on day one of cycle one infusion"
482117|NCT00404248|P6|Participant Flow|Arm 6 -EIASD Level 2|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482281|NCT00403481|O1|Outcome|Overall Study Population|
482118|NCT00404248|P5|Participant Flow|Arm 5 Non-Enzyme Inducing Antiseizure Drug (-EIASD) Level 1|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482119|NCT00404248|P4|Participant Flow|Arm 4 +EIASD Level 4|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation."
482120|NCT00404248|P3|Participant Flow|Arm 3 +EIASD Level 3|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation. Includes pts at the new formulation TC6 at 1700mg"
482121|NCT00404248|P2|Participant Flow|Arm 2 +EIASD Level 2|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation."
482122|NCT00404248|P1|Participant Flow|Arm 1 Enzyme Inducing Antiseizure Drug (+ EIASD) Level 1|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~Pharmacokinetics (PK) data will be collected on day one of cycle one infusion"
482123|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482124|NCT00404248|O1|Outcome|Phase 1 Terameprocol|"subjects were either on the +EIASD antiseizure durgs: (phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine). or not on antiseizure drugs - or those effecting hepatic enzymes ( -EIASD) such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482125|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482126|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482127|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482128|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482129|NCT00404248|O2|Outcome|Arm 2 -EIASD|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482130|NCT00404248|O1|Outcome|Arm 1 +EIASD|"subjects on the +EIASD treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Starting dose is 750mg/day. Dose escalation is 750, 1100, 1700, 2200, 3000, 4000, 5300, 7000, and 9300. NO intrasubject dose escalation.~PK (pharmacological study) data will be collected on day one of cycle one infusion"
482131|NCT00404248|O9|Outcome|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG. (polyethylene glycol )"
482132|NCT00404248|O8|Outcome|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482149|NCT00404248|E3|Reported Event|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes pts at the new formulation TC6 (-PEG)"
482133|NCT00404248|O7|Outcome|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation and new TC6 -PEG Formulation - Pts treated from both formulations"
482134|NCT00404248|O6|Outcome|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482135|NCT00404248|O5|Outcome|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482136|NCT00404248|O4|Outcome|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482137|NCT00404248|O3|Outcome|+EIASD Level 3 (1700 mg/dayx5D)|"subjects on the +EIASD (Level 3) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 3= 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation; Includes patientss at the new formulation TC6 (-PEG)"
482138|NCT00404248|O2|Outcome|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482139|NCT00404248|O1|Outcome|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482140|NCT00404248|O3|Outcome|ARM 3 (No Stratification)|"Subjects in this group were not stratified based on anti-sezuire medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6."
482141|NCT00404248|O2|Outcome|ARM 2 -EIASD (Enzyme-inducing Antizeizure Drug)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hepatic enzymes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482142|NCT00404248|O1|Outcome|Arm 1 +EIASD (Enzyme-inducing Antizeizure Drug)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure drugs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Various Dose levels 1= 750mg/dayx5; 2=1100mg/dayx5; 3=1700mg/dayx5; 4=2200mg/dayx5~NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482143|NCT00404248|E9|Reported Event|Non Stratified (Both +EIASD and -EIASD)|"Subjects in this group were not stratified based on anti-seizure medication..~Subjects will take terameprocol for 5 consecutive days each month by IV. This was for dose 2200mg/day.~New formulation TC6 - NONPEG or -PEG."
482144|NCT00404248|E8|Reported Event|-EIASD Level 4 (2200 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 4 = 2200mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482145|NCT00404248|E7|Reported Event|-EIASD Level 3 (1700 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 3 = 1700mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion"
482146|NCT00404248|E6|Reported Event|-EIASD Level 2 (1100 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 2 = 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482147|NCT00404248|E5|Reported Event|-EIASD Level 1 (750 mg/dayx5D)|"Subjects in the -EIASD group were either not being treated with antiseizure drugs or were taking ones that did not significantly induce hypatic enzynmes such as gabapentin, lamotrigine, valproic acid, levetiracetam, tiagavine, topiramate, zonisamide and felbamate.~Subjects will take terameprocol for 5 consecutive days each month by IV. Level 1 = 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482148|NCT00404248|E4|Reported Event|+EIASD Level 4 (2200 mg/dayx5D)|"subjects on the +EIASD (Level 4) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 4= 2220mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482150|NCT00404248|E2|Reported Event|+EIASD Level 2 (1100 mg/dayx5D)|"subjects on the +EIASD (Level 2) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 2= 1100mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482151|NCT00404248|E1|Reported Event|+ EIASD Level 1 (750 mg/dayx5D)|"subjects on the +EIASD (Level 1) treatment arm were taking one of these antiseizure durgs: phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine.~Subjects will take terameprocol for 5 consecutive days each month by IV. Dose level 1= 750mg/day. NO intrasubject dose escalation.~PK data will be collected on day one of cycle one infusion~+PEG Formulation"
482152|NCT00404092|B5|Baseline|Total|Total of all reporting groups
482153|NCT00404092|B4|Baseline|4th Cohort|"200mg 1x/day~caspofungin : i.v."
482154|NCT00404092|B3|Baseline|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
482155|NCT00404092|B2|Baseline|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
482156|NCT00404092|B1|Baseline|1st Cohort|"70mg 1x/day~caspofungin : i.v."
482157|NCT00404092|P4|Participant Flow|4th Cohort|"200mg 1x/day~caspofungin : i.v."
482158|NCT00404092|P3|Participant Flow|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
482159|NCT00404092|P2|Participant Flow|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
482160|NCT00404092|P1|Participant Flow|1st Cohort|"70mg 1x/day~caspofungin : i.v."
482161|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
482162|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
482163|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
482164|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
482165|NCT00404092|O4|Outcome|4th Cohort|"200mg 1x/day~caspofungin : i.v."
482166|NCT00404092|O3|Outcome|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
482167|NCT00404092|O2|Outcome|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
482168|NCT00404092|O1|Outcome|1st Cohort|"70mg 1x/day~caspofungin : i.v."
482169|NCT00404092|E4|Reported Event|4th Cohort|"200mg 1x/day~caspofungin : i.v."
482170|NCT00404092|E3|Reported Event|3rd Cohort|"150mg 1x/day~caspofungin : i.v."
482171|NCT00404092|E2|Reported Event|2nd Cohort|"100mg 1x/day~caspofungin : i.v."
482172|NCT00404092|E1|Reported Event|1st Cohort|"70mg 1x/day~caspofungin : i.v."
482173|NCT00404079|B3|Baseline|Total|Total of all reporting groups
482174|NCT00404079|B2|Baseline|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
482175|NCT00404079|B1|Baseline|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
482176|NCT00404079|P2|Participant Flow|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
482177|NCT00404079|P1|Participant Flow|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
482178|NCT00404079|O2|Outcome|Glucosamine Sulphate|Glucosamine sulphate was taken daily and orally in capsule forms for 6 months
482179|NCT00404079|O1|Outcome|Placebo|Oral intake of placebo capsules
482180|NCT00404079|E2|Reported Event|Placebo|Placebo was taken daily and orally in capsule forms for 6 months
482181|NCT00404079|E1|Reported Event|Glucosamine Sulphate|The glucosamine sulphate (1500 mg) was taken daily and oral in capsule forms for 6 months
482182|NCT00403845|B1|Baseline|Entire Study Population|The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in 4 different sequences. Two capsules of study medication were inhaled in the morning between 8:00 and 10:00 am on Day 1 of each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482183|NCT00403845|P4|Participant Flow|Indacaterol 600μg-indacaterol 300μg-indacaterol 150μg-placebo|In treatment period 1, patients received 2 indacaterol 300 μg capsules; in treatment period 2, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4 patients received 2 placebo capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482184|NCT00403845|P3|Participant Flow|Indacaterol 300μg-placebo-indacaterol 600μg-indacaterol 150μg|In treatment period 1, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 placebo capsules; in treatment period 3, patients received 2 indacaterol 300 μg capsules; and in treatment period 4, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482185|NCT00403845|P2|Participant Flow|Indacaterol 150μg-indacaterol 600μg-placebo-indacaterol 300μg|In treatment period 1, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 2, patients received 2 indacaterol 300 μg capsules; in treatment period 3, patients received 2 placebo capsules; and in treatment period 4, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482186|NCT00403845|P1|Participant Flow|Placebo-indacaterol 150μg-indacaterol 300μg-indacaterol 600μg|In treatment period, 1 patients received 2 placebo capsules; in treatment period 2, patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; in treatment period 3, patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4, patients received 2 indacaterol 300 μg capsules. There was a washout period of 14-28 days between each treatment period. Patients received each treatment only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482187|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482208|NCT00403767|B2|Baseline|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482188|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482189|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482190|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482191|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482192|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482193|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482194|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482195|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482196|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482197|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482198|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482199|NCT00403845|O4|Outcome|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482200|NCT00403845|O3|Outcome|Indacaterol 150 µg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482201|NCT00403845|O2|Outcome|Indacaterol 300 µg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482202|NCT00403845|O1|Outcome|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482203|NCT00403845|E4|Reported Event|Indacaterol 600 μg|Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482204|NCT00403845|E3|Reported Event|Indacaterol 300 μg|One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482205|NCT00403845|E2|Reported Event|Indacaterol 150 μg|One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482206|NCT00403845|E1|Reported Event|Placebo|Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning between 8:00 and 10:00 am on Day 1 of the treatment period. Placebo was administered to each patient only once. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
482207|NCT00403767|B3|Baseline|Total|Total of all reporting groups
482282|NCT00403481|O1|Outcome|Overall Study Population|
482211|NCT00403767|P1|Participant Flow|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
482212|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482213|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482214|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482215|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482216|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482217|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482218|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482219|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482220|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482221|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482222|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482223|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482224|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482225|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482226|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482227|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482228|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482229|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482230|NCT00403767|O2|Outcome|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482231|NCT00403767|O1|Outcome|Rivaroxaban|Rivaroxaban 20 mg p.o. once daily or matching placebo (15 mg p.o. once daily for patients with a calculated creatinine clearance of 30 – 49 mL/min. at baseline)
482232|NCT00403767|E2|Reported Event|Warfarin|Warfarin (1 mg, 2.5 mg, or 5 mg p.o. once daily)
482233|NCT00403767|E1|Reported Event|Rivaroxaban|Rivaroxaban 15 mg p.o. once daily or Rivaroxaban 20 mg p.o. once daily
482234|NCT00403754|B1|Baseline|Entire Study Population|"The entire study population included all 4 treatment groups who received indacaterol 150 µg, 300 µg, and 600 µg and placebo via a single dose dry powder inhaler (SDDPI) in the 4 different sequences of the core phase. Two capsules of study medication were inhaled in the morning on Day 1 of each treatment period. Following the core phase patients continued to the Salmeterol open label phase. Salmeterol was inhaled via a Diskus inhalation device 50 µg in the morning and 50 µg 12 hours post initial dose on Day 1. Patients received each treatment only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482235|NCT00403754|P4|Participant Flow|Ind 600 μg-Ind 300 μg-Ind150 μg-Placebo-Salmeterol|"In treatment period 1: patients received 2 indacaterol (Ind) 300 μg capsules; in treatment period 2: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 placebo capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
482236|NCT00403754|P3|Participant Flow|Ind 300 μg-Placebo-Ind 600 μg-Ind 150 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 300 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 placebo capsules; in treatment period 3: patients received 2 indacaterol 300 μg capsules; and in treatment period 4: patients received 1 indacaterol 150 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation, device on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use t"
482237|NCT00403754|P2|Participant Flow|Ind 150 μg-Ind 600 μg-Placebo-Ind 300 μg-Salmeterol|"In treatment period 1: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 2: patients received 2 indacaterol 300 μg capsules; in treatment period 3: patients received 2 placebo capsules; and in treatment period 4: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482238|NCT00403754|P1|Participant Flow|Placebo-Ind 150 μg-Ind 300 μg-Ind 600 μg-Salmeterol|"In treatment period 1: patients received 2 placebo capsules; in treatment period 2: patients received 1 indacaterol (Ind) 150 μg capsule + 1 placebo capsule; in treatment period 3: patients received 1 indacaterol 300 μg capsule + 1 placebo capsule; and in treatment period 4: patients received 2 indacaterol 300 μg capsules. Two inhalation capsules of study drug were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of each treatment period at approximately the same time of day +/- 15 minutes. There was a washout period of 14-28 days between each treatment period. In open label treatment period 5: patients received 100 μg salmeterol (50 μg in the morning, 50 μg twelve hours post initial dose) inhaled via Diskus®, an inhalation device, on Day 1.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482239|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482240|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482241|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482242|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482243|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482244|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482245|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482246|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482247|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482248|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482249|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482250|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482251|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482252|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482253|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482254|NCT00403754|O5|Outcome|Salmeterol 100 μg|"Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482255|NCT00403754|O4|Outcome|Placebo|"Two placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Placebo was administered to each patient only once.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482256|NCT00403754|O3|Outcome|Indacaterol 150 µg|"One capsule of indacaterol 150 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 150 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482257|NCT00403754|O2|Outcome|Indacaterol 300 µg|"One capsule of indacaterol 300 µg and 1 placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 300 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482258|NCT00403754|O1|Outcome|Indacaterol 600 µg|"Two capsules of indacaterol 300 µg were inhaled using a single dose dry powder inhaler (SDDPI) device in the morning on Day 1 of the treatment period. Indacaterol 600 µg was administered only once to each patient.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482259|NCT00403754|E5|Reported Event|Salmeterol 100 μg|Open label Salmeterol 100 μg total dose taken on Day 1. 50 μg in the morning and 50 μg twelve hours post initial dose inhaled via Diskus®, an inhalation device for Salmeterol. Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study.
482260|NCT00403754|E4|Reported Event|Placebo|"2 Placebo capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Placebo treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482261|NCT00403754|E3|Reported Event|Indacaterol 600 μg|"2 Indacaterol 300 μg capsules were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 600 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482262|NCT00403754|E2|Reported Event|Indacaterol 300 μg|"1 Indacaterol 300 μg capsules + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 300 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482263|NCT00403754|E1|Reported Event|Indacaterol 150 μg|"1 Indacaterol 150 μg capsule + 1 Placebo capsule were inhaled using a single dose dry powder inhaler (SDDPI) in the morning on day 1 of the Indacaterol 150 μg treatment period.~Daily inhaled corticosteroid treatment (if applicable) was allowed to remain stable throughout the study. The short acting (beta) β2-agonist (SABA) salbutamol was available for rescue use throughout the study."
482264|NCT00403585|B1|Baseline|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482265|NCT00403585|P1|Participant Flow|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482266|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482267|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482268|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482269|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482270|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482271|NCT00403585|O1|Outcome|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482272|NCT00403585|E1|Reported Event|Adefovir Dipivoxil|Adefovir Dipivoxil 10 mg tablets once daily
482273|NCT00403481|B1|Baseline|Active Treatmant Arm|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
482274|NCT00403481|P1|Participant Flow|Active Treatment Period|All participants started this arm with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
482275|NCT00403481|O1|Outcome|Overall Study Population|
482276|NCT00403481|O1|Outcome|Overall Study Population|
482277|NCT00403481|O1|Outcome|Overall Study Population|
482278|NCT00403481|O1|Outcome|Overall Study Population|
482279|NCT00403481|O1|Outcome|Overall Study Population|
482280|NCT00403481|O1|Outcome|Overall Study Population|
482284|NCT00403481|E4|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 25 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
482285|NCT00403481|E3|Reported Event|Olmesartan 40 mg and Hydrochlorothiazide 12.5 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
482286|NCT00403481|E2|Reported Event|Olmesartan 40 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled
482287|NCT00403481|E1|Reported Event|Olmesartan 20 mg|All participants started with 20 mg olmesartan medoxomil (Olm). After 3 weeks participants were titrated to 40g Olm, if their blood pressure was not controlled. After 6 weeks they were titrated to the next step which now included Olm 40 mg + hydrochlorothiazide (HCTZ) 12.5 mg if their blood pressure was not controlled. After 9 weeks they were titrated to the next step which now included Olm + HCTZ 25 mg if their blood pressure was not controlled.
482288|NCT00403455|B1|Baseline|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
482289|NCT00403455|P1|Participant Flow|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment. Both male and female combat veterans ages 18 years and older who meet DSM-III-R criteria for principle diagnosis of PTSD as determined by the CAP-S were recruited for this study.
482290|NCT00403455|O1|Outcome|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
482291|NCT00403455|E1|Reported Event|Paroxetine Arm|This is a single arm, single site, open-label clinical trial to treat veterans with PTSD. It is a 12-week trial to investigate the efficacy of paroxetine in reducing PTSD symptoms, with the primary outcome measure using CAPS. Genetic information is included to understand why some respond and some do not respond to paroxetine treatment.
482292|NCT00403403|B3|Baseline|Total|Total of all reporting groups
482293|NCT00403403|B2|Baseline|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482294|NCT00403403|B1|Baseline|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482295|NCT00403403|P2|Participant Flow|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482296|NCT00403403|P1|Participant Flow|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482297|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482313|NCT00403273|P1|Participant Flow|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482314|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482298|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482299|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482300|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482301|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482302|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482303|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482304|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482305|NCT00403403|O2|Outcome|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482306|NCT00403403|O1|Outcome|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482307|NCT00403403|E2|Reported Event|Bevacizumab+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Bevacizumab 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482308|NCT00403403|E1|Reported Event|Placebo+Chemotherapy|Chemotherapy = cisplatin (or carboplatin) + etoposide. Placebo 15 mg/kg by intravenous (IV) infusion on Day 1 of each of the first four 21-day cycles during chemotherapy, followed by single agent administration until disease progression, unacceptable toxicity, discontinuation from study, or death. Cisplatin 75 mg/m² IV on Day 1 of each of the first four 21-day cycles OR carboplatin (area under the curve [AUC]=5 mg/mL/min, per Calvert formula) IV on Day 1 of each of the first four 21-day cycles; etoposide 100 mg/m² on Days 1-3 of each of the first four 21-day cycles.
482309|NCT00403273|B3|Baseline|Total|Total of all reporting groups
482310|NCT00403273|B2|Baseline|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482311|NCT00403273|B1|Baseline|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482312|NCT00403273|P2|Participant Flow|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482363|NCT00402987|P1|Participant Flow|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482315|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482316|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482317|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482318|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482319|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482320|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482321|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482322|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482323|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482324|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482325|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482326|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482327|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482328|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482329|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482330|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482331|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482332|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482333|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482334|NCT00403273|O2|Outcome|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482335|NCT00403273|O1|Outcome|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482336|NCT00403273|E2|Reported Event|Intra-articular Placebo|Single Intra-articular Injection of 5 cc of normal saline in the Painful TKA at screening visit
482337|NCT00403273|E1|Reported Event|Intra-articular Botulinum Toxin|Single Intra-articular Injection of 100 units of Botulinum toxin A in 5 cc of normal saline in the Painful TKA at screening visit
482338|NCT00403234|B5|Baseline|Total|Total of all reporting groups
482339|NCT00403234|B4|Baseline|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
482340|NCT00403234|B3|Baseline|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
482341|NCT00403234|B2|Baseline|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
482342|NCT00403234|B1|Baseline|Placebo|Placebo transdermal patch applied for 7-day wear
482343|NCT00403234|P4|Participant Flow|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
482344|NCT00403234|P3|Participant Flow|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
482345|NCT00403234|P2|Participant Flow|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
482346|NCT00403234|P1|Participant Flow|Placebo|Placebo transdermal patch applied for 7-day wear.
482347|NCT00403234|O4|Outcome|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
482348|NCT00403234|O3|Outcome|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
482349|NCT00403234|O2|Outcome|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
482350|NCT00403234|O1|Outcome|Placebo|Placebo transdermal patch applied for 7-day wear
482351|NCT00403234|E4|Reported Event|BTDS 30|Buprenorphine transdermal patch 10 + 20 mcg/h applied for 7-day wear
482352|NCT00403234|E3|Reported Event|BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
482353|NCT00403234|E2|Reported Event|BTDS 10|Buprenorphine transdermal patch 10 mcg/h applied for 7-day wear
482354|NCT00403234|E1|Reported Event|Placebo|Placebo transdermal patch applied for 7-day wear.
482355|NCT00402987|B5|Baseline|Total|Total of all reporting groups
482356|NCT00402987|B4|Baseline|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482357|NCT00402987|B3|Baseline|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482358|NCT00402987|B2|Baseline|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
482359|NCT00402987|B1|Baseline|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482360|NCT00402987|P4|Participant Flow|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482361|NCT00402987|P3|Participant Flow|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482362|NCT00402987|P2|Participant Flow|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
482364|NCT00402987|O4|Outcome|Placebo|
482414|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482415|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482416|NCT00402987|O3|Outcome|Placebo|
482417|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482418|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482419|NCT00402987|O4|Outcome|Placebo|
482420|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482421|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482422|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482423|NCT00402987|O3|Outcome|Placebo|
482424|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482425|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482426|NCT00402987|O4|Outcome|Placebo|
482427|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482428|NCT00402987|O2|Outcome|Celecoxib 100mg /Placebo|
482429|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482430|NCT00402987|O3|Outcome|Placebo|
482431|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482432|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482433|NCT00402987|O4|Outcome|Placebo|
482434|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482435|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482436|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482437|NCT00402987|O3|Outcome|Placebo|
482438|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482439|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482440|NCT00402987|O4|Outcome|Placebo|
482441|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482442|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482443|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482444|NCT00402987|O3|Outcome|Placebo|
482445|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482446|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482447|NCT00402987|O3|Outcome|Placebo|
482448|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482449|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482450|NCT00402987|O4|Outcome|Placebo|
482451|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482452|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482453|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482454|NCT00402987|O3|Outcome|Placebo|
482455|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482456|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482457|NCT00402987|O4|Outcome|Placebo|
482458|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482459|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482460|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482461|NCT00402987|O3|Outcome|Placebo|
482462|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482463|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482464|NCT00402987|O3|Outcome|Placebo|
482465|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482466|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482467|NCT00402987|O4|Outcome|Placebo|
482468|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|
482469|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|
482470|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482471|NCT00402987|O3|Outcome|Placebo|
482472|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482473|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482474|NCT00402987|O4|Outcome|Placebo|
482475|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
482476|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
482477|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482478|NCT00402987|O3|Outcome|Placebo|
482479|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482480|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482481|NCT00402987|O3|Outcome|Placebo|
482482|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482483|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482484|NCT00402987|O3|Outcome|Placebo|
482485|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482486|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482487|NCT00402987|O3|Outcome|Placebo|
482488|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482489|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482490|NCT00402987|O4|Outcome|Placebo|
482491|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
482492|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
482493|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482494|NCT00402987|O3|Outcome|Placebo|
482495|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482496|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482497|NCT00402987|O4|Outcome|Placebo|
482498|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
482499|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
482500|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482501|NCT00402987|O3|Outcome|Placebo|
482502|NCT00402987|O2|Outcome|Celecoxib 100 mg (Pooled)|
482503|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482504|NCT00402987|O4|Outcome|Placebo|
482505|NCT00402987|O3|Outcome|Celecoxib 100mg / 50mg|
482506|NCT00402987|O2|Outcome|Celecoxib 100 mg / Placebo|
482507|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482508|NCT00402987|O3|Outcome|Placebo|
482509|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|
482510|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|
482511|NCT00402987|O4|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482512|NCT00402987|O3|Outcome|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482513|NCT00402987|O2|Outcome|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
482514|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
483902|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
482515|NCT00402987|O3|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482516|NCT00402987|O2|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
482517|NCT00402987|O1|Outcome|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482518|NCT00402987|O2|Outcome|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482519|NCT00402987|O1|Outcome|Celecoxib 100mg (Pooled)|Treatment groups 2 and 3 (celecoxib 100 mg/placebo and celecoxib 100 mg/50 mg) were pooled
482520|NCT00402987|E4|Reported Event|Placebo|Dose 1 placebo followed 6-12 hours later by dose 2 placebo
482521|NCT00402987|E3|Reported Event|Celecoxib 100mg/50mg|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482522|NCT00402987|E2|Reported Event|Celecoxib 100mg/Placebo|Dose 1 celecoxib 100 mg followed 6-12 hours later by dose 2 placebo
482523|NCT00402987|E1|Reported Event|Celecoxib 50mg/50mg|Dose 1 celecoxib 50 mg followed 6-12 hours later by dose 2 celecoxib 50 mg
482524|NCT00402896|B1|Baseline|ZD6474|300 mg/day orally for 10 weeks.
482525|NCT00402896|P1|Participant Flow|ZD6474|300 mg/day orally for 10 weeks.
482526|NCT00402896|O1|Outcome|ZD6474|300 mg/day orally for 10 weeks.
482527|NCT00402896|E1|Reported Event|ZD6474|300 mg/day orally for 10 weeks.
482528|NCT00402883|B1|Baseline|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
482529|NCT00402883|P1|Participant Flow|Pemetrexed/Carboplatin/Radiotherapy and Bevacizumab|"Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines.~Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy."
482530|NCT00402883|O1|Outcome|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
482531|NCT00402883|E1|Reported Event|Intervention|Induction treatment included: carboplatin AUC=5, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously weeks 1 and 4. Radiation was administered concurrently at a dose of 1.8 Gy/d weeks 1 to 7 to a total of 61.2 Gy per institutional guidelines. Consolidative therapy, following an 8-week break from chemoradiotherapy, included carboplatin AUC=6, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg each administered intravenously on week 16, repeated weeks 19 and 22. Folic acid (350 to 1,000 ug or equivalent) supplementation was administered orally beginning 1 to 2 weeks before the first dose of pemetrexed and continued daily until the patient discontinued study therapy. Vitamin B12(1,000ug) was administered by intramuscular injection 1 to 2 weeks before the first dose of study therapy and repeated every 9 weeks until the patient discontinued therapy.
482532|NCT00402740|B1|Baseline|Group 1|
482533|NCT00402740|P1|Participant Flow|Group 1|
482534|NCT00402740|O1|Outcome|Group 1|
482535|NCT00402740|O1|Outcome|Group 1|
482536|NCT00402740|O1|Outcome|Group 1|
482537|NCT00402740|O3|Outcome|Emboshield Gen 3|Participants receiving Emboshield Gen 3 Emboshield Gen3 success were counted per filter.
482538|NCT00402740|O2|Outcome|Emboshield Pro Gen 5|Participants receiving Emboshield Pro Gen 5. Emboshield Pro success were counted per filter.
482539|NCT00402740|O1|Outcome|Xact Stent|The Xact stent success were counted per subject
482540|NCT00402740|O1|Outcome|Group 1|Includes only the most serious event for each subject and includes only each subject's first occurrence of the event.
482541|NCT00402740|E1|Reported Event|Group 1|
482542|NCT00402727|B3|Baseline|Total|Total of all reporting groups
482543|NCT00402727|B2|Baseline|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482544|NCT00402727|B1|Baseline|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482545|NCT00402727|P2|Participant Flow|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482546|NCT00402727|P1|Participant Flow|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482547|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482548|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482549|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482550|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482551|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482552|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482553|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482554|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482555|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482556|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482557|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482558|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482559|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482560|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482561|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482562|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482563|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482564|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482565|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482566|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482567|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482568|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482569|NCT00402727|O2|Outcome|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482570|NCT00402727|O1|Outcome|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482571|NCT00402727|E2|Reported Event|PIP/TAZ-AMC|Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
482572|NCT00402727|E1|Reported Event|Moxifloxacin|Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory.
482573|NCT00402714|B3|Baseline|Total|Total of all reporting groups
482938|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482574|NCT00402714|B2|Baseline|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482575|NCT00402714|B1|Baseline|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482576|NCT00402714|P2|Participant Flow|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482577|NCT00402714|P1|Participant Flow|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482578|NCT00402714|O2|Outcome|Pento TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482579|NCT00402714|O1|Outcome|ECP Pento TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482580|NCT00402714|O2|Outcome|2 Pent/TBI|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482581|NCT00402714|O1|Outcome|1 ECP and Pent/TBI|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482582|NCT00402714|E2|Reported Event|Pent|"Pentostatin and total body irradiation~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482583|NCT00402714|E1|Reported Event|ECP/Pent|"Extracorporeal photopheresis, pentostatin and total body irradiation~extracorporeal photopheresis: Extracorporeal photopheresis (ECP) is the ex vivo exposure of the leukocyte rich fraction to ultraviolet light in the presence of 8-methoxypsoralen.~Pentostatin: pentostatin 8mg/m2 over 48 hours by continuous infusion~Total Body Irradiation: 600cGy TBI in 3 200cGy TBI fractions"
482584|NCT00402688|B4|Baseline|Total|Total of all reporting groups
482585|NCT00402688|B3|Baseline|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482586|NCT00402688|B2|Baseline|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482587|NCT00402688|B1|Baseline|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482588|NCT00402688|P3|Participant Flow|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482589|NCT00402688|P2|Participant Flow|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482590|NCT00402688|P1|Participant Flow|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482591|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482592|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482593|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482594|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482595|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482596|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482597|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482598|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482599|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482600|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482601|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482602|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482603|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482604|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482605|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482606|NCT00402688|O3|Outcome|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482607|NCT00402688|O2|Outcome|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482608|NCT00402688|O1|Outcome|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
482609|NCT00402688|E3|Reported Event|Levofloxacin 500mg for 4 Weeks|levofloxacin, 500mg tablet once daily for 4 weeks.
482610|NCT00402688|E2|Reported Event|Levofloxacin 750mg for 3 Weeks|levofloxacin, 750mg tablet once daily for 3 weeks followed by 1 week of placebo.
482611|NCT00402688|E1|Reported Event|Levofloxacin 750mg for 2 Weeks|levofloxacin, 750mg tablet once daily for 2 weeks followed by 2 weeks of placebo.
483103|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
482612|NCT00402649|B1|Baseline|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482613|NCT00402649|P1|Participant Flow|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482614|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482615|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482616|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482617|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482618|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482619|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482620|NCT00402649|O1|Outcome|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482621|NCT00402649|E1|Reported Event|Inactivated Influenza A/H5N1 Vaccine|All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart.
482622|NCT00402597|B6|Baseline|Total|Total of all reporting groups
482623|NCT00402597|B5|Baseline|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482624|NCT00402597|B4|Baseline|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482625|NCT00402597|B3|Baseline|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482626|NCT00402597|B2|Baseline|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
482627|NCT00402597|B1|Baseline|Placebo|One placebo tablet twice daily for 6 months.
482628|NCT00402597|P5|Participant Flow|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482629|NCT00402597|P4|Participant Flow|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482630|NCT00402597|P3|Participant Flow|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482631|NCT00402597|P2|Participant Flow|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily)
482632|NCT00402597|P1|Participant Flow|Placebo|One placebo tablet twice daily for 6 months.
482633|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482634|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482635|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482636|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482637|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482638|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482639|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482640|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482641|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482642|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482643|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482644|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482645|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482646|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482647|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482648|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482649|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482650|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482651|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482652|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482653|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482654|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482655|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482656|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482657|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482658|NCT00402597|O5|Outcome|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482659|NCT00402597|O4|Outcome|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482660|NCT00402597|O3|Outcome|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482661|NCT00402597|O2|Outcome|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482662|NCT00402597|O1|Outcome|Placebo|One Placebo tablet twice daily for 6 months.
482663|NCT00402597|E5|Reported Event|Riva 20 mg TDD|Rivaroxaban 20 mg (10 mg twice a day or 20 mg once daily) for 6 months.
482664|NCT00402597|E4|Reported Event|Riva 15 mg TDD|Rivaroxaban 15 mg (7.5 mg twice a day or 15 mg once daily) for 6 months.
482665|NCT00402597|E3|Reported Event|Riva 10 mg TDD|Rivaroxaban 10 mg (5 mg twice a day or 10 mg once daily) for 6 months.
482666|NCT00402597|E2|Reported Event|Riva 5 mg Total Daily Dose (TDD)|Rivaroxaban 5 mg (2.5 mg twice a day or 5 mg once daily) for 6 months.
482667|NCT00402597|E1|Reported Event|Placebo|One placebo tablet twice daily for 6 months.
482668|NCT00402363|B5|Baseline|Total|Total of all reporting groups
482669|NCT00402363|B4|Baseline|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482670|NCT00402363|B3|Baseline|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482671|NCT00402363|B2|Baseline|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482672|NCT00402363|B1|Baseline|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
482673|NCT00402363|P4|Participant Flow|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482674|NCT00402363|P3|Participant Flow|Persistent AF, P-OM3|Participants with persistent AF receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24. Persistent AF was defined as AF that had been terminated at least once with pharmacologic/electrical cardioversion. A documented episode of symptomatic persistent AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482675|NCT00402363|P2|Participant Flow|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an ECG or TTM tracing associated with symptoms consistent with AF in the participant's medical record.
482676|NCT00402363|P1|Participant Flow|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 grams (g) per day for the first 7 days; 4 g per day thereafter through Week 24. Paroxysmal AF was defined as AF that had never been treated with pharmacologic/electrical therapy to terminate an episode. A documented episode of symptomatic paroxysmal AF was defined as AF documented by an electrocardiogram (ECG) or transtelephonic monitoring (TTM) tracing associated with symptoms consistent with AF in the participant's medical record.
482677|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482678|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482679|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482680|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482681|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482682|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482683|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482684|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482685|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482686|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482687|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482688|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482689|NCT00402363|O6|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482690|NCT00402363|O5|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482691|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482692|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482693|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482694|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482695|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482696|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482697|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482698|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482699|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482700|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482701|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482702|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482703|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482704|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482705|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482706|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482707|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482708|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482709|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482710|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482711|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482712|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482713|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482714|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482715|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482716|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482717|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482718|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482719|NCT00402363|O2|Outcome|Combined, P-OM3|Participants with paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482720|NCT00402363|O1|Outcome|Combined, Placebo|Participants with paroxysmal and persistent AF receiving matching placebo
482721|NCT00402363|O4|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482722|NCT00402363|O3|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482723|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482724|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482725|NCT00402363|O4|Outcome|Combined, P-OM3|Participants with both paroxysmal and persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482726|NCT00402363|O3|Outcome|Combined, Placebo|Participants with both paroxysmal and persistent AF receiving matching placebo
482727|NCT00402363|O2|Outcome|Persistent AF, P-OM3|Participants with persistent atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482728|NCT00402363|O1|Outcome|Persistent AF, Placebo|Participants with persistent AF receiving matching placebo
482729|NCT00402363|O2|Outcome|Paroxysmal AF, P-OM3|Participants with paroxysmal atrial fibrillation (AF) receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482730|NCT00402363|O1|Outcome|Paroxysmal AF, Placebo|Participants with paroxysmal AF receiving matching placebo
482731|NCT00402363|E2|Reported Event|Prescription Omega-3 Acid Ethyl Esters|Participants receiving P-OM3, 8 g per day for the first 7 days; 4 g per day thereafter through Week 24
482732|NCT00402363|E1|Reported Event|Placebo|Participants receiving matching placebo
482733|NCT00402337|B6|Baseline|Total|Total of all reporting groups
482734|NCT00402337|B5|Baseline|Placebo|Dose-matched placebo, oral administration, once per day.
482735|NCT00402337|B4|Baseline|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482736|NCT00402337|B3|Baseline|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482737|NCT00402337|B2|Baseline|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day. One patient was randomized into the study but did not receive ≥ 1 dose of study drug, thus was not included in the Safety Population.
482738|NCT00402337|B1|Baseline|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482739|NCT00402337|P5|Participant Flow|Placebo|Dose-matched placebo, oral administration, once per day.
482740|NCT00402337|P4|Participant Flow|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482741|NCT00402337|P3|Participant Flow|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482742|NCT00402337|P2|Participant Flow|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482743|NCT00402337|P1|Participant Flow|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482744|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482745|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482746|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482747|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482748|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482749|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482750|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482751|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482752|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482753|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482754|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482755|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482756|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482757|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482758|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482759|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482760|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482761|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482762|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482763|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482764|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482765|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482766|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482767|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482768|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482769|NCT00402337|O5|Outcome|Placebo|Dose-matched placebo, oral administration, once per day.
482770|NCT00402337|O4|Outcome|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482771|NCT00402337|O3|Outcome|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482772|NCT00402337|O2|Outcome|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482773|NCT00402337|O1|Outcome|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482774|NCT00402337|E5|Reported Event|Placebo|Dose-matched placebo, oral administration, once per day.
482775|NCT00402337|E4|Reported Event|Linaclotide, 579μg|Linaclotide, 579μg dose, oral administration, once per day
482776|NCT00402337|E3|Reported Event|Linaclotide, 290μg|Linaclotide, 290μg dose, oral administration, once per day
482777|NCT00402337|E2|Reported Event|Linaclotide, 145μg|Linaclotide, 145μg dose, oral administration, once per day
482778|NCT00402337|E1|Reported Event|Linaclotide, 72μg|Linaclotide, 72μg dose, oral administration, once per day
482779|NCT00402324|B3|Baseline|Total|Total of all reporting groups
482780|NCT00402324|B2|Baseline|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482781|NCT00402324|B1|Baseline|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482782|NCT00402324|P2|Participant Flow|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482783|NCT00402324|P1|Participant Flow|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482784|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482785|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482786|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482787|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
483104|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
482788|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482789|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482790|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482791|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482792|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482793|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482794|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482795|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482796|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482797|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482798|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482799|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482800|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482801|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482802|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482803|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482804|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482805|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482806|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482807|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482808|NCT00402324|O2|Outcome|Placebo|Placebo: placebo capsules, by mouth every evening, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I).
482809|NCT00402324|O1|Outcome|Olanzapine|"Olanzapine: 15mg, capsules, by mouth every evening, daily for minimum of one day, followed by 5-20mg, capsules, by mouth every evening, daily for remainder of study (6 weeks total).~Divalproex: dose to maintain blood levels of 75-125 ug/mL, by mouth, twice a day, daily for 6 weeks (following dose achieved in Study Period I)."
482810|NCT00402324|E2|Reported Event|Placebo|Placebo: placebo capsules, PO, at Q HS, daily, for 6 weeks. Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following dose achieved in Study Period I).
482965|NCT00402103|O3|Outcome|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
483105|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
482811|NCT00402324|E1|Reported Event|Olanzapine|Olanzapine: 15mg, capsules, PO at Q HS, daily for 1 week followed by 5-20mg, capsules, PO at Q HS daily for 5 weeks (6 weeks total). Divalproex: dose to maintain blood levels of 75-125 ug/mL, PO, BID, daily for 6 weeks (following d ose achieved in Study Period I)
482812|NCT00402285|B4|Baseline|Total|Total of all reporting groups
482813|NCT00402285|B3|Baseline|Placebo|men took placebo for lycopene & placebo for fish oil.
482814|NCT00402285|B2|Baseline|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
482815|NCT00402285|B1|Baseline|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
482816|NCT00402285|P3|Participant Flow|Placebo|men took placebo for lycopene & placebo for fish oil.
482817|NCT00402285|P2|Participant Flow|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
482818|NCT00402285|P1|Participant Flow|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
482819|NCT00402285|O3|Outcome|Placebo|men took placebo for lycopene & placebo for fish oil.
482820|NCT00402285|O2|Outcome|Fish Oil Supplement|"three 1g fish oil capsules daily including 1,098mg EPA & 549mg DHA fatty acid (Roche).~men took fish oil & placebo for lycopene."
482821|NCT00402285|O1|Outcome|Lycopene Supplement|two 15mg lycopene soft gel capsules daily (Lyc-O-Mato). men took lycopene & placebo for fish oil.
482822|NCT00402285|E1|Reported Event|All Participants|
482823|NCT00402246|B3|Baseline|Total|Total of all reporting groups
482824|NCT00402246|B2|Baseline|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482825|NCT00402246|B1|Baseline|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482826|NCT00402246|P2|Participant Flow|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482827|NCT00402246|P1|Participant Flow|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482828|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
482829|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
482830|NCT00402246|O1|Outcome|Enrolled Subjects|All enrolled subjects who completed some portion of the caregiver burden survey at 1 month visit
482831|NCT00402246|O1|Outcome|Clinicians|Clinicians who responded to the survey
482832|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482833|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482834|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482835|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482836|NCT00402246|O1|Outcome|Patients With a Study CRT-D Device|Patients in either the Remote Arm or the In-office Arm who were implanted with a study CRT-D Device, as these are the only devices that have Left Ventricular leads
483106|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
482837|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482838|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482839|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482840|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482841|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482842|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482843|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482844|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482845|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482846|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482847|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482966|NCT00402103|O2|Outcome|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
483107|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
482848|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482849|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482850|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482851|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482852|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482853|NCT00402246|O2|Outcome|In-Office Arm|In-office care, consisting of standard follow-up procedures for a device patient such as review of the patient's device data during a patient's scheduled in-office visit
482854|NCT00402246|O1|Outcome|Remote Arm|"Wireless remote monitoring, consisting of 3 components:~CareAlerts: Device alerts that are triggered by either device integrity issues or arrhythmic issues with the patient (e.g. multiple shocks delivered for a ventricular arrhythmia, more than 12 hours of atrial arrhythmias occurring in a day)~Conexus: the device feature which allows the device to wirelessly transmit information (possibly triggered by a CareAlert) to a patient monitor that is hooked up a patient's phone line~CareLink: the Medtronic system which allows device data to be transmitted from a patient's monitor through the phone line to ultimately be displayed on a secure website for viewing by the patient's physician.~The combination of these 3 components allow the patient's device to transmit information relating to either a device issue or patient issue to be viewed by a clinician without the patient having to take direct action."
482855|NCT00402246|E1|Reported Event|Enrolled Subjects|All enrolled subjects in the study
482856|NCT00402233|B5|Baseline|Total|Total of all reporting groups
482857|NCT00402233|B4|Baseline|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482858|NCT00402233|B3|Baseline|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482859|NCT00402233|B2|Baseline|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482860|NCT00402233|B1|Baseline|Placebo|matching tablet
482861|NCT00402233|P4|Participant Flow|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482862|NCT00402233|P3|Participant Flow|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482863|NCT00402233|P2|Participant Flow|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482864|NCT00402233|P1|Participant Flow|Placebo|matching tablet
482865|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482967|NCT00402103|O1|Outcome|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
482866|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482867|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482868|NCT00402233|O1|Outcome|Placebo|matching tablet
482869|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482870|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482871|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482872|NCT00402233|O1|Outcome|Placebo|matching tablet
482873|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482874|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482875|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482876|NCT00402233|O1|Outcome|Placebo|matching tablet
482877|NCT00402233|O4|Outcome|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482878|NCT00402233|O3|Outcome|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482879|NCT00402233|O2|Outcome|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482880|NCT00402233|O1|Outcome|Placebo|matching tablet
482881|NCT00402233|E4|Reported Event|Mirapex (Pramipexole 0.5 mg Tid)|Week 1: Pramipexole 0.125 mg tid, Week 2: Pramipexole 0.25 mg tid, Week 3: Pramipexole 0.5 mg tid, Week 4 to Week 12: Pramipexole 0.5 mg tid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482882|NCT00402233|E3|Reported Event|Mirapex (Pramipexole 0.75 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.75 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482883|NCT00402233|E2|Reported Event|Mirapex (Pramipexole 0.5 mg Bid)|Week 1: Pramipexole 0.125 mg bid, Week 2: Pramipexole 0.25 mg bid, Week 3: Pramipexole 0.5 mg bid, Week 4 to Week 12: Pramipexole 0.5 mg bid. After the initial 4 week titration period, each dosage group will maintain the specified dosage for an additional 8 weeks, to complete the 12 week double-blind period.
482884|NCT00402233|E1|Reported Event|Placebo|matching tablet
482885|NCT00402194|B3|Baseline|Total|Total of all reporting groups
482886|NCT00402194|B2|Baseline|Placebo|Placebo
482887|NCT00402194|B1|Baseline|Treatment|Treatment with 100mg of losartan daily or placebo. Outcomes measured before and after 3 months of treatment.
482888|NCT00402194|P2|Participant Flow|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
482889|NCT00402194|P1|Participant Flow|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
482890|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
482891|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
482892|NCT00402194|O2|Outcome|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
482893|NCT00402194|O1|Outcome|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
482894|NCT00402194|E2|Reported Event|Placebo|Treatment with double blinded placebo daily. Outcomes measured before and after 3 months of treatment.
482895|NCT00402194|E1|Reported Event|Treatment|Treatment with 100mg of losartan daily. Outcomes measured before and after 3 months of treatment.
482896|NCT00402168|B3|Baseline|Total|Total of all reporting groups
482968|NCT00402103|E3|Reported Event|Aliskiren 300mg/ Amlodipine 10mg/ HCTZ|Aliskiren 300mg and Amlodipine 10mg tablets and HCTZ capsules once a day in the morning
482897|NCT00402168|B2|Baseline|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482898|NCT00402168|B1|Baseline|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482899|NCT00402168|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482900|NCT00402168|P1|Participant Flow|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
482901|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
482902|NCT00402168|O1|Outcome|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants who had been randomized to CNI were allowed to switch to belatacept. For those switching to belatacept, the CNI dose was tapered and discontinued, after which they received belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received belatacept 5 mg/kg IV every 28 days.
482903|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482904|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482905|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482906|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482907|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482908|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482909|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482910|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482911|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482912|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482913|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482914|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482915|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482916|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482969|NCT00402103|E2|Reported Event|Aliskiren 300mg/ Amlodipine 10mg Alone|Aliskiren 300mg and Amlodipine 10mg tablets once a day in the morning
483108|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
482917|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482918|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482919|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482920|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482921|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482922|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482923|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482924|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482925|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482926|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482927|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482928|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482929|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482930|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482931|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482932|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482933|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482934|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482935|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482936|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg given IV every 28 days.
482937|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482939|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482940|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482941|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm by Year 3.
482942|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days.
482943|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and tacrolimus TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482944|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482945|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482946|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482947|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482948|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg IV every 28 days.
482949|NCT00402168|O2|Outcome|Calcineurin Inhibitor (CNI)|Participants received a CNI-based immunosuppressive regimen, CsA and TAC. CsA was to be adjusted to maintain a range of trough concentrations of 100 - 250 ng/mL. TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the LT period, participants were allowed to switch to the belatacept arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the belatacept arm.
482950|NCT00402168|O1|Outcome|Belatacept 5 mg/kg|Belatacept 5 mg/kg was given IV every 28 days.
482951|NCT00402168|E3|Reported Event|Belatacept 5 mg/kg in Participants Switched During LT Period|During the long term treatment period participants were allowed to switch from CNI to Belatacept. For those switching to Belatacept, the CNI dose was tapered and discontinued, after which they received Belatacept 5 mg/kg IV every 2 weeks for 2 months. Thereafter, they received Belatacept 5 mg/kg IV every 28 days. Adverse events reported for participants who were switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period on or after their first Belatacept dose.
482952|NCT00402168|E2|Reported Event|Calcineurin Inhibitor (CNI)|Participants received a calcineurin inhibitor (CNI)-based immunosuppressive regimen, Cyclosporin A (CsA) and tacrolimus (TAC). CsA was to be adjusted to maintain a range of trough serum concentrations of 100 - 250 nanograms per milliliter (ng/mL). TAC doses were to be adjusted to maintain a range of trough serum concentrations of 5 - 10 ng/mL. During the long term (LT) treatment period participants were allowed to switch to Belatacept treatment arm. In October 2011 (Year 3), the CNI arm was discontinued. CNI participants were considered to have completed treatment (not discontinued) at that time, if they did not switch to the Belatacept arm. Adverse events reported for participants who were treated with only CNI for the entire study and those who were later switched from Calcineurin Inhibitor (CNI) treatment to Belatacept 5 mg/kg during the LT period prior to their first Belatacept dose.
482953|NCT00402168|E1|Reported Event|Belatacept 5 mg/kg|Belatacept 5 milligrams per kilogram of body weight (mg/kg) given intravenously (IV) every 28 days. Adverse events reported for participants who were treated with only Belatacept throughout the study.
482954|NCT00402103|B3|Baseline|Total|Total of all reporting groups
482955|NCT00402103|B2|Baseline|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
482956|NCT00402103|B1|Baseline|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
482957|NCT00402103|P2|Participant Flow|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
482958|NCT00402103|P1|Participant Flow|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
482959|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
482960|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
482961|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
482962|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
482963|NCT00402103|O2|Outcome|Aliskiren/Amlodipine/HCTZ|Aliskiren and Amlodipine tablets and HCTZ capsules once a day in the morning
482964|NCT00402103|O1|Outcome|Aliskiren/Amlodipine|Aliskiren and Amlodipine tablets once a day in the morning
482970|NCT00402103|E1|Reported Event|Aliskiren 150mg/ Amlodipine 5mg Alone|Aliskiren 150mg and Amlodipine 5mg tablets once a day in the morning
482971|NCT00402051|B3|Baseline|Total|Total of all reporting groups
482972|NCT00402051|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482973|NCT00402051|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482974|NCT00402051|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482975|NCT00402051|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482976|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482977|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482978|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482979|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482980|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482981|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482982|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482983|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482984|NCT00402051|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482985|NCT00402051|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482986|NCT00402051|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed 500 mg/m2 intravenous (IV); Carboplatin area under the concentration curve (AUC) 5 IV, every 21 days for 6 cycles
482987|NCT00402051|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed 500 mg/m2 intravenous (IV); Cisplatin 75 mg/m2 IV, every 21 days for 6 cycles
482988|NCT00402025|B4|Baseline|Total|Total of all reporting groups
482989|NCT00402025|B3|Baseline|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482990|NCT00402025|B2|Baseline|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482991|NCT00402025|B1|Baseline|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482992|NCT00402025|P3|Participant Flow|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482993|NCT00402025|P2|Participant Flow|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482994|NCT00402025|P1|Participant Flow|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴plaque-forming units (PFU)/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482995|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482996|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482997|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
482998|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483089|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483090|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
482999|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483000|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483001|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483002|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483003|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483004|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483005|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483006|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483007|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483008|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483009|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483010|NCT00402025|O3|Outcome|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483011|NCT00402025|O2|Outcome|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483012|NCT00402025|O1|Outcome|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483013|NCT00402025|E3|Reported Event|Talimogene Laherparepvec 10⁶ / 10⁷ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁶ PFU/mL followed by 2 doses of 10⁷ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483014|NCT00402025|E2|Reported Event|Talimogene Laherparepvec 10⁵ / 10⁶ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁵ PFU/mL followed by 2 doses of 10⁶ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483015|NCT00402025|E1|Reported Event|Talimogene Laherparepvec 10⁴/ 10⁵ PFU/mL|"Participants received 3 doses of talimogene laherparepvec; an initial dose of 10⁴PFU/mL followed by 2 doses of 10⁵ PFU/mL, each 3 weeks apart.~At the discretion of the investigator, treatment with talimogene laherparepvec could continue beyond the third dose until Week 15 in a regimen of at least 3 weeks between doses."
483016|NCT00401973|B4|Baseline|Total|Total of all reporting groups
483017|NCT00401973|B3|Baseline|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483091|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483092|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483018|NCT00401973|B2|Baseline|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483019|NCT00401973|B1|Baseline|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483020|NCT00401973|P3|Participant Flow|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483021|NCT00401973|P2|Participant Flow|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483022|NCT00401973|P1|Participant Flow|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483023|NCT00401973|O2|Outcome|22 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
483024|NCT00401973|O1|Outcome|2 Weeks|"Combined treatment groups:~olanzapine plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks].~Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)].~Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information [olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)]."
483025|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483026|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483027|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483028|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483029|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483030|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483031|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483032|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483033|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483034|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483035|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483036|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483037|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483038|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483039|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483093|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483094|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483040|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483041|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483042|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483043|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483044|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483045|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483046|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483047|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483048|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483049|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483050|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483051|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483052|NCT00401973|O3|Outcome|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483053|NCT00401973|O2|Outcome|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483054|NCT00401973|O1|Outcome|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483055|NCT00401973|E3|Reported Event|Olanzapine + Metformin|"Olanzapine and Pharmacological Algorithm 1b - metformin first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. metformin: 500 mg, oral, twice a day for 2 weeks, titrated to 500 mg three times a day thereafter. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483056|NCT00401973|E2|Reported Event|Olanzapine + Amantadine|"Olanzapine and Pharmacological Algorithm 1a - amantadine first plus behavioral information.~olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks. amantadine: 100 mg, oral, twice a day. zonisamide: 100-400 mg, oral, daily (only if patient gained greater than 3 kilograms)."
483057|NCT00401973|E1|Reported Event|Olanzapine|olanzapine plus behavioral information. olanzapine: 5-20 milligrams (mg), oral, daily for 22 weeks.
483058|NCT00401843|B4|Baseline|Total|Total of all reporting groups
483059|NCT00401843|B3|Baseline|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483060|NCT00401843|B2|Baseline|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483061|NCT00401843|B1|Baseline|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
483095|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483062|NCT00401843|P3|Participant Flow|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483063|NCT00401843|P2|Participant Flow|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483064|NCT00401843|P1|Participant Flow|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
483065|NCT00401843|O3|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483066|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483067|NCT00401843|O1|Outcome|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
483068|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483069|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483070|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483096|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483097|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483098|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483099|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483100|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483101|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483102|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483071|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483072|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483073|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483074|NCT00401843|O2|Outcome|Part 2 - Bortezomib + Siltuximab|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483075|NCT00401843|O1|Outcome|Part 2 - Bortezomib + Placebo|Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles.
483076|NCT00401843|E3|Reported Event|Part 2 - Bortezomib + Siltuximab|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with Siltuximab administered as intravenous infusion once every 2 weeks during 42-day treatment phase. Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13-day rest period (cycle Days 23 to 35) along with Siltuximab administered as intravenous infusion once every 2 weeks for 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity.~Dexamethasone 40 mg/day will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483077|NCT00401843|E2|Reported Event|Part 2 - Bortezomib + Placebo|"Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 4, 8, 11, followed by a 10- day rest period; and on Days 22, 25, 29, and 32 followed by a 10-day rest period along with matching placebo administered as intravenous infusion once every 2 weeks during 42-day treatment phase.~Bortezomib 1.3 mg/m^2 will be administered as intravenous bolus on Days 1, 8, 15, 22 followed by a 13- day rest period (cycle Days 23 to 35) along with matching placebo once every 2 weeks during 35-day Maintenance Phase. Dexamethasone tablet will be administered at first occurrence of documented disease progression or if bortezomib was discontinued due to intolerable toxicity. Dexamethasone 40 milligram per day (mg/day) will be administered on days 1-4, 9-12, and 17-20 for four 28-day cycles then 40 mg/day for Days 1-4 for all subsequent cycles."
483078|NCT00401843|E1|Reported Event|Part 1 - Bortezomib + Siltuximab|Siltuximab 6 milligram per kilogram (mg/kg) will be administered as intravenous infusion once every 2 weeks along with bortezomib 1.3 milligram per square meter (mg/m^2) during cycle 1.
483079|NCT00401830|B3|Baseline|Total|Total of all reporting groups
483080|NCT00401830|B2|Baseline|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483081|NCT00401830|B1|Baseline|Placebo|Matching placebo tablet (administered twice daily)
483082|NCT00401830|P2|Participant Flow|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483083|NCT00401830|P1|Participant Flow|Placebo|Matching placebo tablet (administered twice daily)
483084|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483085|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483086|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483087|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483088|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483109|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483110|NCT00401830|O2|Outcome|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483111|NCT00401830|O1|Outcome|Placebo|Matching placebo tablet (administered twice daily)
483112|NCT00401830|E2|Reported Event|Lacosamide|Lacosamide Tablet 400mg daily (administered twice daily)
483113|NCT00401830|E1|Reported Event|Placebo|Matching placebo tablet (administered twice daily)
483114|NCT00401778|B4|Baseline|Total|Total of all reporting groups
483115|NCT00401778|B3|Baseline|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483116|NCT00401778|B2|Baseline|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
483117|NCT00401778|B1|Baseline|Control|No everolimus taken.
483118|NCT00401778|P3|Participant Flow|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483119|NCT00401778|P2|Participant Flow|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
483120|NCT00401778|P1|Participant Flow|Control|No everolimus taken.
483121|NCT00401778|O2|Outcome|Everolimus 5 or 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483122|NCT00401778|O1|Outcome|Control|No everolimus taken.
483123|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483124|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
483125|NCT00401778|O1|Outcome|Control|No everolimus taken.
483126|NCT00401778|O3|Outcome|Everolimus 10 mg|Everolimus dose of 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483127|NCT00401778|O2|Outcome|Everolimus 5 mg|Everolimus dose of 5 mg/day for 21-28 days sequentially taken orally in tablet form.
483128|NCT00401778|O1|Outcome|Control|No everolimus taken.
483129|NCT00401778|E2|Reported Event|Everolimus 5 & 10 mg|Everolimus dose of 5 or 10 mg/day for 21-28 days sequentially taken orally in tablet form.
483130|NCT00401778|E1|Reported Event|Control|No everolimus taken.
483131|NCT00401752|B3|Baseline|Total|Total of all reporting groups
483132|NCT00401752|B2|Baseline|Ranitidine|ranitidine 150 mg capsule bid oral administration
483133|NCT00401752|B1|Baseline|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483134|NCT00401752|P2|Participant Flow|Ranitidine|ranitidine 150 mg capsule bid oral administration
483135|NCT00401752|P1|Participant Flow|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483136|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483137|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483138|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483139|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483140|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483141|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483142|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483143|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483144|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483145|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483146|NCT00401752|O2|Outcome|Ranitidine|ranitidine 150 mg capsule bid oral administration
483147|NCT00401752|O1|Outcome|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483148|NCT00401752|E2|Reported Event|Ranitidine|ranitidine 150 mg capsule bid oral administration
483149|NCT00401752|E1|Reported Event|Esomeprazole|Esomeprazole 20 mg tablet qd oral administration
483150|NCT00401726|B3|Baseline|Total|Total of all reporting groups
483151|NCT00401726|B2|Baseline|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483152|NCT00401726|B1|Baseline|Venlafaxine Extended Release (ER)|75-225 mg per day
483153|NCT00401726|P2|Participant Flow|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483154|NCT00401726|P1|Participant Flow|Venlafaxine Extended Release (ER)|75-225 mg per day
483155|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|"Venlafaxine ER 75-225 mg per day plus Dialogues Time to Talk program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication."
483156|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483157|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483158|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483159|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483160|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483161|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483162|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483163|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483164|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483165|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483166|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483167|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483168|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483169|NCT00401726|O2|Outcome|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483170|NCT00401726|O1|Outcome|Venlafaxine Extended Release (ER)|75-225 mg per day
483171|NCT00401726|E2|Reported Event|Venlafaxine Extended Release (ER) Plus Dialogues|Venlafaxine ER 75-225 mg per day plus “Dialogues Time to Talk” program (Dialogues). Dialogues is a patient management program designed to reinforce physician treatment efforts, provide feedback to treating physicians and encourage better physician-patient communication.
483172|NCT00401726|E1|Reported Event|Venlafaxine Extended Release (ER)|75-225 mg per day
483173|NCT00401622|B3|Baseline|Total|Total of all reporting groups
483174|NCT00401622|B2|Baseline|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
483175|NCT00401622|B1|Baseline|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
483176|NCT00401622|P2|Participant Flow|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
483177|NCT00401622|P1|Participant Flow|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
483178|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
483179|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
483180|NCT00401622|O2|Outcome|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
483181|NCT00401622|O1|Outcome|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
483182|NCT00401622|E2|Reported Event|Standard Care|Control group receiving standard care with a traditional blood glucose monitoring system
483183|NCT00401622|E1|Reported Event|OneTouch® Ultra®2 System|Test care group assigned to OneTouch® Ultra®2 System
483184|NCT00401544|B5|Baseline|Total|Total of all reporting groups
483185|NCT00401544|B4|Baseline|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483186|NCT00401544|B3|Baseline|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483187|NCT00401544|B2|Baseline|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483188|NCT00401544|B1|Baseline|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483189|NCT00401544|P4|Participant Flow|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483190|NCT00401544|P3|Participant Flow|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483191|NCT00401544|P2|Participant Flow|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483192|NCT00401544|P1|Participant Flow|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483193|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483194|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483195|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483196|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483197|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483198|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483199|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483200|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483201|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483202|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483203|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483204|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483205|NCT00401544|O4|Outcome|Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483206|NCT00401544|O3|Outcome|Darbepoetin Alfa 500 μg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483207|NCT00401544|O2|Outcome|Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483208|NCT00401544|O1|Outcome|Darbepoetin Alfa 300 μg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483209|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483210|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483211|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483212|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483213|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483214|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483215|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483216|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483217|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483218|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483219|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483220|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483221|NCT00401544|O2|Outcome|Combined With Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483222|NCT00401544|O1|Outcome|Combined Without Iron Groups|Darbepoetin alfa 300 μg or 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483223|NCT00401544|O2|Outcome|Combined Darbepoetin Alfa 500 μg|Darbepoetin alfa 500 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483224|NCT00401544|O1|Outcome|Combined Darbepoetin Alfa 300 μg|Darbepoetin alfa 300 μg subcutaneous injection with or without intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483225|NCT00401544|E4|Reported Event|Darbepoetin Alfa 500 µg Plus Iron|Darbepoetin alfa 500 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483226|NCT00401544|E3|Reported Event|Darbepoetin Alfa 500 µg (Without Iron)|Darbepoetin alfa 500 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483227|NCT00401544|E2|Reported Event|Darbepoetin Alfa 300 µg Plus Iron|Darbepoetin alfa 300 μg subcutaneous injection plus intravenous (IV) iron 400 mg, every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483228|NCT00401544|E1|Reported Event|Darbepoetin Alfa 300 µg (Without IV Iron)|Darbepoetin alfa 300 μg subcutaneous injection every three weeks (Q3W), for up to 15 weeks (a total of 5 doses).
483229|NCT00401531|B3|Baseline|Total|Total of all reporting groups
483230|NCT00401531|B2|Baseline|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483231|NCT00401531|B1|Baseline|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483232|NCT00401531|P2|Participant Flow|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483391|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483233|NCT00401531|P1|Participant Flow|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483234|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483235|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483236|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483237|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483238|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483239|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483240|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483241|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483242|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483243|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483244|NCT00401531|O2|Outcome|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483245|NCT00401531|O1|Outcome|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483246|NCT00401531|E2|Reported Event|Infanrix Hexa™ + Prevnar™|Participants received a 3-dose primary vaccination series of Infanrix hexa vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483247|NCT00401531|E1|Reported Event|DTaP-IPV-Hep B-PRP-T + Prevnar™|Participants received a 3-dose primary vaccination series of diphtheria, tetanus, pertussis (2 component acellular), recombinant hepatitis B Hansenula and poliovirus vaccine adsorbed, and Haemophilus influenzae type B vaccine, conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T) vaccine co-administered with Prevnar vaccine (at 2, 4, and 6 months of age). All participants had received hepatitis B vaccination at birth.
483248|NCT00401414|B4|Baseline|Total|Total of all reporting groups
483249|NCT00401414|B3|Baseline|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
483317|NCT00401245|P2|Participant Flow|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483318|NCT00401245|P1|Participant Flow|DVS 25 mg, Then 100 mg|Desvenlafaxine succinate (DVS) 25 milligram (mg) tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week open label (OL) phase.
483901|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483250|NCT00401414|B2|Baseline|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483251|NCT00401414|B1|Baseline|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483252|NCT00401414|P3|Participant Flow|Dosing Algorithm C|Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin’s PD effect as evident in the acquired patient data. Simulations using Algorithm C were repeated using the clinical endpoints described above to derive the optimal starting warfarin doses and titration scheme that was tested prospectively in subsequent patients enrolled in the CROWN study.
483253|NCT00401414|P2|Participant Flow|Dosing Algorithm B|Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483254|NCT00401414|P1|Participant Flow|Dosing Algorithm A|"Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483255|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
483256|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483257|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483258|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
483319|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483320|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483321|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483259|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483260|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483261|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
483262|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483263|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483264|NCT00401414|O3|Outcome|Dosing Algorithm C|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm C was generated as an update of dosing Algorithm B and was based upon additional patient data, similar to what was described above for Algorithm B, from the prospective accrual of 203 patients in the CROWN trial. The major difference between Algorithm B and Algorithm C was an update of the half maximal inhibitory concentration (IC50) estimate for each VKORC1 haplotype in the model used to generate Algorithm B to reflect warfarin's PD effect as evident in the acquired patient data.
483265|NCT00401414|O2|Outcome|Dosing Algorithm B|Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Dosing Algorithm B was generated from an analysis of warfarin dose, INR, genetic factors, demographic factors and concomitant drug therapy from an initial prospective group of 74 patients treated using Algorithm A. Using these data, a mechanistic concentration-INR model was constructed to refine the estimates of the effect of CYP2C9 genotypes, VKORC1 haplotypes, age, and concomitant medications.
483266|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483267|NCT00401414|O3|Outcome|Dosing Algorithm C|
483268|NCT00401414|O2|Outcome|Dosing Algorithm B|
483322|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483323|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483633|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483269|NCT00401414|O1|Outcome|Dosing Algorithm A|"Three dosing algorithms (A, B, and C, respectively) were used in this investigation. The algorithms were developed sequentially to select both an initial warfarin dose and a titration scheme intended to maximise the likelihood of achieving and maintaining the target INR. The algorithms were refined using adaptive methods that allow for continual reassessment of patient-level data to optimize the predictive power of the algorithms. Algorithm A was a dosing decision-tree that included both clinical and genetic factors. It was based upon optimal clinical practice at the Brigham and Women's Hospital's Anticoagulation Management Service as well as published literature that has utilised warfarin pharmacogenetics.~Doses were subsequently adjusted based on serial INR measurements."
483270|NCT00401414|E3|Reported Event|Dosing Algorithm C|
483271|NCT00401414|E2|Reported Event|Dosing Algorithm B|
483272|NCT00401414|E1|Reported Event|Dosing Algorithm A|
483273|NCT00401401|B5|Baseline|Total|Total of all reporting groups
483274|NCT00401401|B4|Baseline|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483275|NCT00401401|B3|Baseline|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483276|NCT00401401|B2|Baseline|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483277|NCT00401401|B1|Baseline|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483278|NCT00401401|P4|Participant Flow|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483279|NCT00401401|P3|Participant Flow|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483280|NCT00401401|P2|Participant Flow|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483281|NCT00401401|P1|Participant Flow|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483282|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483283|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483284|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483285|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483286|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483287|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483288|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483289|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483290|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483291|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483292|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483293|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483294|NCT00401401|O4|Outcome|Zalutumumab 16 mg/kg|
483295|NCT00401401|O3|Outcome|Zalutumumab 12 mg/kg|
483296|NCT00401401|O2|Outcome|Zalutumumab 8 mg/kg|
483297|NCT00401401|O1|Outcome|Zalutumumab 4 mg/kg|
483298|NCT00401401|E4|Reported Event|Zalutumumab 16 mg/kg|Zalutumumab 8 weekly infusions
483299|NCT00401401|E3|Reported Event|Zalutumumab 12 mg/kg|Zalutumumab 8 weekly infusions
483300|NCT00401401|E2|Reported Event|Zalutumumab 8 mg/kg|Zalutumumab 8 weeky infusions
483301|NCT00401401|E1|Reported Event|Zalutumumab 4 mg/kg|Zalutumumab 8 weekly infusions
483302|NCT00401258|B1|Baseline|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
483303|NCT00401258|P1|Participant Flow|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
483304|NCT00401258|O1|Outcome|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
483305|NCT00401258|E1|Reported Event|Duloxetine, 60 mg Daily|Open-label duloxetine was administered for a duration of 12 weeks. Subjects received duloxetine 30 mg daily for 1 week followed by duloxetine 60 mg daily for 11 weeks.
483306|NCT00401245|B5|Baseline|Total|Total of all reporting groups
483307|NCT00401245|B4|Baseline|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483308|NCT00401245|B3|Baseline|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483309|NCT00401245|B2|Baseline|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483310|NCT00401245|B1|Baseline|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483311|NCT00401245|P8|Participant Flow|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483312|NCT00401245|P7|Participant Flow|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483313|NCT00401245|P6|Participant Flow|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483314|NCT00401245|P5|Participant Flow|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally every other day (QOD) alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483315|NCT00401245|P4|Participant Flow|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483316|NCT00401245|P3|Participant Flow|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483390|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483324|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483325|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483326|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483327|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
483328|NCT00401245|O1|Outcome|DVS 100 mg|DVS 100 mg tablet taken orally daily for 15 weeks (OL phase).
483329|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483330|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483331|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483332|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483333|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483334|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483335|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483336|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483337|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483338|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483339|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483340|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483341|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483342|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483343|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483344|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483345|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483346|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483347|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483348|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483349|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483350|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483351|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483352|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483353|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483354|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483355|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483356|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483357|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483358|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483359|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483360|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483361|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483362|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483363|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483364|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483365|NCT00401245|O4|Outcome|Placebo|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483366|NCT00401245|O3|Outcome|DVS 50 mg/Placebo|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483367|NCT00401245|O2|Outcome|DVS 50/25 mg|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483368|NCT00401245|O1|Outcome|DVS 50 mg QOD|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483369|NCT00401245|O4|Outcome|DVS 100 mg, Then 100 mg|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483370|NCT00401245|O3|Outcome|DVS 50 mg, Then 100 mg|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483371|NCT00401245|O2|Outcome|DVS 25/50 mg, Then 100 mg|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483372|NCT00401245|O1|Outcome|DVS 25 mg, Then 100 mg|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase); then 100 mg for 15 week OL phase.
483373|NCT00401245|E9|Reported Event|Placebo (Tapering Phase)|Re-randomized to placebo tablets matched to 25 mg and 50 mg taken orally daily for two weeks (double blind tapering phase).
483374|NCT00401245|E8|Reported Event|DVS 50 mg/Placebo (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week and placebo matched to 25 mg. For further 1 week, participants received placebo matched to 25 mg and 50 mg (double blind tapering phase).
483375|NCT00401245|E7|Reported Event|DVS 50/25 mg (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally daily for first week along with placebo matched to 25 mg. For further 1 week, participants received DVS 25 mg tablet orally daily and placebo matched to 50 mg (double blind tapering phase).
483376|NCT00401245|E6|Reported Event|DVS 50 mg QOD (Tapering Phase)|Re-randomized to DVS 50 mg tablet taken orally QOD alternating with placebo matched to 50 mg QOD and placebo matched to 25 mg daily for 2 weeks (double blind tapering phase).
483377|NCT00401245|E5|Reported Event|DVS 100 mg (OL Phase)|After 1 week of double blind titration phase, DVS 100 mg tablet taken orally daily for 15 weeks.
483378|NCT00401245|E4|Reported Event|DVS 100 mg (Titration Phase)|DVS 100 mg tablet taken orally daily for one week and placebo matched to 25 mg and 50 mg (double blind titration phase).
483379|NCT00401245|E3|Reported Event|DVS 50 mg (Titration Phase)|DVS 50 mg tablet taken orally daily for one week and placebo matched to 100 mg and 25 mg (double blind titration phase).
483380|NCT00401245|E2|Reported Event|DVS 25/50 mg (Titration Phase)|DVS 25 mg tablet taken orally for first 4 days followed by 50 mg for next 3 days for the first week and placebo matched to 100 mg (double blind titration phase).
483381|NCT00401245|E1|Reported Event|DVS 25 mg (Titration Phase)|DVS 25 mg tablet taken orally daily for one week and placebo matched to 100 mg and 50 mg (double blind titration phase).
483382|NCT00401193|B4|Baseline|Total|Total of all reporting groups
483383|NCT00401193|B3|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483384|NCT00401193|B2|Baseline|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
483385|NCT00401193|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483386|NCT00401193|P3|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483387|NCT00401193|P2|Participant Flow|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
483388|NCT00401193|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483389|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483392|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483393|NCT00401193|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483394|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483395|NCT00401193|O3|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483396|NCT00401193|O2|Outcome|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
483397|NCT00401193|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483398|NCT00401193|E3|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
483399|NCT00401193|E2|Reported Event|1950 mg/Day|One 650 mg Lysteda (tranexamic acid) tablet and one matching placebo tablet taken 3 times daily (1950 mg/day) for a maximum of 5 days during monthly menstruation
483400|NCT00401193|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
483401|NCT00401102|B1|Baseline|Group 1|All participants recieved Interpersonal psychotherapy
483402|NCT00401102|P1|Participant Flow|Group 1|All participants recieved Interpersonal psychotherapy
483403|NCT00401102|O1|Outcome|Group 1|All participants recieved Interpersonal psychotherapy
483404|NCT00401102|E1|Reported Event|Group 1|All participants recieved Interpersonal psychotherapy
483405|NCT00400881|B3|Baseline|Total|Total of all reporting groups
483406|NCT00400881|B2|Baseline|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
483407|NCT00400881|B1|Baseline|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
483408|NCT00400881|P2|Participant Flow|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
483409|NCT00400881|P1|Participant Flow|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
483410|NCT00400881|O2|Outcome|ATC (Automatic Tube Compensation)|Automatic Tube Compensation
483411|NCT00400881|O1|Outcome|CPAP|Continuous Positive Airway Pressure
483412|NCT00400881|O2|Outcome|ATC (Automatic Tube Compensation)|Automatic Tube Compensation
483413|NCT00400881|O1|Outcome|CPAP (Continuous Positive Airway Pressure)|Continuous Positive Airway Pressure
483414|NCT00400881|E2|Reported Event|Automatic Tube Compensation (ATC)|ATC mode of ventilation (intervention, not-standard mode)
483415|NCT00400881|E1|Reported Event|CPAP (Continuous Positive Airway Pressure)|CPAP (continuous positive airway pressure)(standard mode of ventilation, non-intervention control group)
483416|NCT00400829|B1|Baseline|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483417|NCT00400829|P1|Participant Flow|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483418|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483419|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483420|NCT00400829|O1|Outcome|Arm I|"Patients receive 1.4 mg/m2 eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483421|NCT00400829|E1|Reported Event|Arm I|"Patients receive eribulin mesylate IV over 1-2 minutes on days 1 and 8. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~eribulin mesylate: Given IV"
483422|NCT00400803|B1|Baseline|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483423|NCT00400803|P1|Participant Flow|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483424|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483425|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483475|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483426|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483427|NCT00400803|O4|Outcome|Progressive Disease|At least a 20% increase in the sum of the longest diameters of target lesions, taking as reference the smallest sum longest diameter recorded since the baseline measurements, or the appearance of one or more new lesion(s).
483428|NCT00400803|O3|Outcome|Stable Disease|Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease. To be assigned a status of stable disease, measurements must have met the stable disease criteria at least once after study entry at a minimum interval.
483429|NCT00400803|O2|Outcome|Partial Response|At least a 30% decrease in the sum of the longest diameters of target lesions, taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than four weeks after the criteria for response are first met.
483430|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine, Carboplatin and Avastin IV every 14 days.
483431|NCT00400803|O1|Outcome|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483432|NCT00400803|E1|Reported Event|Intent To Treat - Lung Cancer Patients|Patients with Stage III-IV non-small cell lung cancer treated with Gemcitabine 2000mg/m^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
483433|NCT00400764|B6|Baseline|Total|Total of all reporting groups
483434|NCT00400764|B5|Baseline|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483435|NCT00400764|B4|Baseline|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483436|NCT00400764|B3|Baseline|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483437|NCT00400764|B2|Baseline|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483438|NCT00400764|B1|Baseline|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483439|NCT00400764|P5|Participant Flow|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483440|NCT00400764|P4|Participant Flow|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483441|NCT00400764|P3|Participant Flow|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483442|NCT00400764|P2|Participant Flow|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483443|NCT00400764|P1|Participant Flow|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483444|NCT00400764|O2|Outcome|Phase II Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants may also have received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483445|NCT00400764|O1|Outcome|Phase Ib Dulanermin|Participants received 4.0 mg/kg/day or 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483446|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483447|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483448|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483622|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483449|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483450|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483451|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483452|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483453|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483454|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483455|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483456|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483457|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483458|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483459|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483460|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483461|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483462|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483463|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483464|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483465|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483466|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483467|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483468|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483469|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483470|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483471|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483472|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483473|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483474|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483623|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483476|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483477|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483478|NCT00400764|O3|Outcome|Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483479|NCT00400764|O2|Outcome|Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483480|NCT00400764|O1|Outcome|Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483481|NCT00400764|O5|Outcome|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483482|NCT00400764|O4|Outcome|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483483|NCT00400764|O3|Outcome|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483484|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483485|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483486|NCT00400764|O2|Outcome|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483487|NCT00400764|O1|Outcome|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483488|NCT00400764|E5|Reported Event|Phase II - Dulanermin|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
483489|NCT00400764|E4|Reported Event|Phase II - Combination Therapy|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483490|NCT00400764|E3|Reported Event|Phase II - Rituximab|Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m^2 weekly for up to eight doses.
483491|NCT00400764|E2|Reported Event|Phase Ib - Dulanermin 8 mg/kg|Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483492|NCT00400764|E1|Reported Event|Phase Ib - Dulanermin 4 mg/kg|Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m^2 weekly for up to eight doses.
483493|NCT00400712|B3|Baseline|Total|Total of all reporting groups
483494|NCT00400712|B2|Baseline|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483495|NCT00400712|B1|Baseline|Control|natural progression post-stroke
483496|NCT00400712|P2|Participant Flow|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months (and one year)
483497|NCT00400712|P1|Participant Flow|Control|no intervention, natural history following stroke
483498|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483499|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483500|NCT00400712|O2|Outcome|Intervention|two weeks of goal directed intensive physical rehabilitation therapy aimed at improving mobility at 6 months .
483501|NCT00400712|O1|Outcome|Control|no intervention, natural progression post-stroke
483502|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483503|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483504|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483505|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483506|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483507|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483508|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483509|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483510|NCT00400712|O2|Outcome|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483511|NCT00400712|O1|Outcome|Control|natural progression post-stroke
483512|NCT00400712|E2|Reported Event|Intervention|"two weeks of goal directed intensive physical rehabilitation therapy at 6 months (and one year)~physical rehabilitation: two weeks intensive physical rehabilitation"
483513|NCT00400712|E1|Reported Event|Control|natural progression post-stroke
483514|NCT00400686|B1|Baseline|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483515|NCT00400686|P1|Participant Flow|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483516|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483517|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483518|NCT00400686|O1|Outcome|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483519|NCT00400686|E1|Reported Event|Epoetin Alfa - 80,000 U sc|"Epoetin Alfa will be administered 80,000 units subcutaneously every week beginning on Day 1. On Day 28, the dose was adjusted based upon patients' Hemoglobin Levels~epoetin alfa: Epoetin alfa will be administered 80,000 u sc every week commencing on study day 1."
483520|NCT00400634|B3|Baseline|Total|Total of all reporting groups
483521|NCT00400634|B2|Baseline|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
483522|NCT00400634|B1|Baseline|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
483523|NCT00400634|P2|Participant Flow|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
483524|NCT00400634|P1|Participant Flow|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
483525|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
483526|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
483527|NCT00400634|O2|Outcome|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
483528|NCT00400634|O1|Outcome|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
483529|NCT00400634|E2|Reported Event|Sham Surgery Control Group|Subjects who were randomized to undergo sham surgery (partial burr holes)
483530|NCT00400634|E1|Reported Event|CERE-120 Treatment Group|Subjects who were randomized to receive bilateral intraputaminal administration of CERE-120 (5.4 x 10^11 vg)
483531|NCT00400569|B1|Baseline|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
483532|NCT00400569|P1|Participant Flow|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
483533|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
483534|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483535|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483536|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483537|NCT00400569|O3|Outcome|Malignant Fibrous Histiocytoma (MFH) Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483538|NCT00400569|O2|Outcome|Leiomyosarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483539|NCT00400569|O1|Outcome|Liposarcoma Cohort Only|Experimental: Sunitinib Malate (SU011248) Treatment
483540|NCT00400569|O1|Outcome|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
483541|NCT00400569|E1|Reported Event|Experimental: Sunitinib Malate (SU011248) Treatment|Sunitinib malate, 50 mg daily, for 4 weeks every 6 weeks
483542|NCT00400400|B3|Baseline|Total|Total of all reporting groups
483543|NCT00400400|B2|Baseline|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483544|NCT00400400|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483624|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483625|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483545|NCT00400400|P2|Participant Flow|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483546|NCT00400400|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483547|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483548|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483549|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483550|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483551|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483552|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483553|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483554|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483555|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483556|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483557|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483558|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483626|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483627|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483628|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483629|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483559|NCT00400400|O2|Outcome|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483560|NCT00400400|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483561|NCT00400400|E2|Reported Event|Mycophenolate Mofetil|Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483562|NCT00400400|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
483563|NCT00400205|B1|Baseline|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
483564|NCT00400205|P1|Participant Flow|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
483565|NCT00400205|O1|Outcome|TPF Induction in Head and Neck Cancer|Phase II single arm study of TPF induction therapy in patients with head and neck cancer.
483566|NCT00400205|E1|Reported Event|TPF Induction Therapy for Head and Neck Cancer|Patients with locally advanced squamous cell carcinoma of the head and neck received three cycles of induction therapy with TPF followed by local therapy consisting of surgical resection in addition to possible radiation therapy with or without concurrent chemotherapy.
483567|NCT00400179|B3|Baseline|Total|Total of all reporting groups
483568|NCT00400179|B2|Baseline|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483569|NCT00400179|B1|Baseline|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483570|NCT00400179|P2|Participant Flow|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483571|NCT00400179|P1|Participant Flow|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483572|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483573|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483574|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483575|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483576|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483630|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483631|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483632|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483577|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483578|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483579|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483580|NCT00400179|O2|Outcome|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483581|NCT00400179|O1|Outcome|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483582|NCT00400179|E2|Reported Event|5-FU/Cisplatin|In the 5-FU/cisplatin arm, 5-FU 1000 mg/m2/24 hours was administered by continuous intravenous infusion on Days 1 through 5 following cisplatin 100 mg/m2 administered IV as a 1- to 3-hour infusion on Day 1. This regimen was repeated every 4 weeks with a maximum of 6 cycles.
483583|NCT00400179|E1|Reported Event|S-1/Cisplatin|"In the S-1/cisplatin arm, S-1 25 mg/m2 was taken orally two times daily for 21 days followed by a 7-day recovery period. The patient was instructed to have nothing by mouth 1 hour prior to and 1 hour after S-1 administration. S-1 was taken with a glass of water and prior to cisplatin infusion on Day 1.~Cisplatin 75 mg/m2 was administered as a 1- to 3-hour intravenous (IV) infusion after the morning dose of S-1 on Day 1 of each cycle. This regimen was repeated every 4 weeks with a maximum of 6 cycles of treatment."
483584|NCT00400153|B4|Baseline|Total|Total of all reporting groups
483585|NCT00400153|B3|Baseline|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483586|NCT00400153|B2|Baseline|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483587|NCT00400153|B1|Baseline|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483588|NCT00400153|P3|Participant Flow|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483589|NCT00400153|P2|Participant Flow|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483590|NCT00400153|P1|Participant Flow|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483591|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483592|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483593|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483594|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483595|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483596|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483597|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483598|NCT00400153|O3|Outcome|Ipratropium Respimat 20 Mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483599|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483600|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483601|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483602|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483603|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483604|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483605|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483606|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to rating of turning
483607|NCT00400153|O1|Outcome|Number of Patients|Total number of patients due to device preference
483608|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483609|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483610|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483611|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483612|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483613|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483614|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483615|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483616|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483617|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483618|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483619|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483620|NCT00400153|O2|Outcome|RESPIMAT Device|Respimat Inhalers
483621|NCT00400153|O1|Outcome|MDI Device|MDI Inhalers
483634|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483635|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483636|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483637|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483638|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483639|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483640|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483641|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483642|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483643|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483644|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483645|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483646|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483647|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483648|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483649|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483650|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483651|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483652|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483653|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483654|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483655|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483656|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483657|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483658|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483659|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483660|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483661|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483662|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483663|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483664|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483665|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483666|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483667|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483668|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483669|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483670|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483671|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483672|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483673|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483674|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483675|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483676|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483677|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483678|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483679|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483680|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483681|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483682|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483683|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483684|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483685|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483686|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483687|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483688|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483689|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483690|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483691|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483692|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483693|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483694|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483695|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483696|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483697|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483698|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483699|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483700|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483701|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483702|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483703|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483704|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483705|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483706|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483707|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483708|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483709|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483710|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483711|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483712|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483713|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483714|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483715|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483716|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483717|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483718|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483719|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483720|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483721|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483722|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483723|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483724|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483725|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483726|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483727|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483728|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483729|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483730|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483731|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483732|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483733|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483734|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483735|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483736|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483737|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483738|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483739|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483740|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483741|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483742|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483743|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483744|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483745|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483746|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483747|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483748|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483749|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483750|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483751|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483752|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483753|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483754|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483755|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483756|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483757|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483758|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483759|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483760|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483761|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483762|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483763|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483764|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483765|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483766|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483767|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483768|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483769|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483770|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483771|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483772|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483773|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483774|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483775|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483776|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483777|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483778|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483779|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483780|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483781|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483782|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483783|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483784|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483785|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483786|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483787|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483788|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483789|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483790|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483791|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483792|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483793|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483794|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483795|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483796|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483797|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483798|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483799|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483800|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483801|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483802|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483803|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483804|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483805|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483806|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483807|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483808|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483809|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483810|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483811|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483812|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483813|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483814|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483815|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483816|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483817|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483818|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483819|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483820|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483821|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483822|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483823|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483824|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483825|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483826|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483827|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483828|NCT00400153|O3|Outcome|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483829|NCT00400153|O2|Outcome|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483830|NCT00400153|O1|Outcome|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483831|NCT00400153|E3|Reported Event|Ipratropium Respimat 20 mcg|Atrovent Respimat (20 mcg) plus placebo COMBIVENT MDI
483832|NCT00400153|E2|Reported Event|COMBIVENT CFC-MDI 36/206 mcg|COMBIVENT MDI (36/206 mcg ) plus placebo Combivent Respimat
483833|NCT00400153|E1|Reported Event|COMBIVENT Respimat 20/100 mcg|Combivent Respimat (20 mcg/100 mcg) plus placebo COMBIVENT MDI
483834|NCT00399893|B3|Baseline|Total|Total of all reporting groups
483835|NCT00399893|B2|Baseline|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483836|NCT00399893|B1|Baseline|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483837|NCT00399893|P2|Participant Flow|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483838|NCT00399893|P1|Participant Flow|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483839|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483840|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483841|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483842|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483843|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483844|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483845|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483846|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483847|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483848|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483849|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483850|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483851|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483852|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483853|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483900|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483854|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483855|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483856|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483857|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483858|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483859|NCT00399893|O2|Outcome|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483860|NCT00399893|O1|Outcome|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483861|NCT00399893|E2|Reported Event|Placebo Comparator|Placebo to be administered by subcutaneous injection three times daily while on study
483862|NCT00399893|E1|Reported Event|Octreotide|"Octreotide :~Octreotide : Octreotide or placebo to be administered by subcutaneous injection three times daily"
483863|NCT00399763|B3|Baseline|Total|Total of all reporting groups
483864|NCT00399763|B2|Baseline|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483865|NCT00399763|B1|Baseline|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483866|NCT00399763|P2|Participant Flow|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483867|NCT00399763|P1|Participant Flow|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483868|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483869|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483870|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483871|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483872|NCT00399763|O2|Outcome|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483873|NCT00399763|O1|Outcome|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483874|NCT00399763|E2|Reported Event|Atomoxetine|The participants received atomoxetine for their ADHD and CBT for their substance use disorder. The atomoxetine was titrated to 100 mg daily unless participants were less then 70 kg. In that case, they were titrated to 1.2 mg/kg per day.
483875|NCT00399763|E1|Reported Event|Placebo|The participants received placebo plus CBT for their substance use disorder for 12 weeks.
483876|NCT00399568|B3|Baseline|Total|Total of all reporting groups
483877|NCT00399568|B2|Baseline|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
483878|NCT00399568|B1|Baseline|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
483879|NCT00399568|P2|Participant Flow|IV Placebo 100 mL Solution|All subjects randomized to receive Intravenous (IV) placebo 100 mL solution every 6 hours for 48 hours for a total of 8 doses.
483880|NCT00399568|P1|Participant Flow|IV Acetaminophen 1 g/100 mL Solution|All subjects randomized to receive Intravenous (IV) Acetaminophen 1 g/100 mL solution every 6 hours for 48 hours for a total of 8 doses.
483881|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
483882|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
483883|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
483884|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
483885|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|Safety Population(defined as those subjects who received any portion of a dose of IV Placebo 100 ml solution)
483886|NCT00399568|O1|Outcome|IV Acetaminophen 1g/100 ml Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 ml solution)
483887|NCT00399568|O2|Outcome|IV Placebo 100 ml Solution|mITT Population IV Placebo 100 ml solution
483888|NCT00399568|O1|Outcome|IV Acetaminophen 1 g/100 ml Solution|mITT Population IV acetaminophen 1 g/100 ml Solution
483889|NCT00399568|E2|Reported Event|IV Placebo 100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV Placebo 100 mL solution)
483890|NCT00399568|E1|Reported Event|IV Acetaminophen 1g/100 mL Solution|Safety Population (defined as those subjects who received any portion of a dose of IV acetaminophen 1g/100 mL solution)
483891|NCT00399542|B3|Baseline|Total|Total of all reporting groups
483892|NCT00399542|B2|Baseline|Placebo|Subjects who received placebo
483893|NCT00399542|B1|Baseline|Lubiprostone|Subjects who received active drug
483894|NCT00399542|P2|Participant Flow|Placebo|Subjects who received placebo
483895|NCT00399542|P1|Participant Flow|Lubiprostone|Subjects who received active drug
483896|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483897|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483898|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483899|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483903|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483904|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483905|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483906|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483907|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483908|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483909|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483910|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483911|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483912|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483913|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483914|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483915|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483916|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483917|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483918|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483919|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483920|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483921|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483922|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483923|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483924|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483925|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483926|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483927|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483928|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483929|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483930|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483931|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483932|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483933|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483934|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483935|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483936|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483937|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483938|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483939|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483940|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483941|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483942|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483943|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483944|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483945|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483946|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483947|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483948|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483949|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483950|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483951|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483952|NCT00399542|O2|Outcome|Placebo|Subjects who received placebo
483953|NCT00399542|O1|Outcome|Lubiprostone|Subjects who received active drug
483954|NCT00399542|E2|Reported Event|Placebo|Subjects who received placebo
483955|NCT00399542|E1|Reported Event|Lubiprostone|Subjects who received active drug
483956|NCT00399516|B1|Baseline|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
483957|NCT00399516|P1|Participant Flow|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
483958|NCT00399516|O1|Outcome|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) treatment group programmed using a randomly assigned sequence of stimulation parameters (i.e. pulse widths)
483959|NCT00399516|E1|Reported Event|Spinal Cord Stimulation Programming Parameters|Spinal Cord Stimulation (SCS) Treatment Group
483960|NCT00399360|B5|Baseline|Total|Total of all reporting groups
483961|NCT00399360|B4|Baseline|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483962|NCT00399360|B3|Baseline|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483963|NCT00399360|B2|Baseline|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483964|NCT00399360|B1|Baseline|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483965|NCT00399360|P4|Participant Flow|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483966|NCT00399360|P3|Participant Flow|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483967|NCT00399360|P2|Participant Flow|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483968|NCT00399360|P1|Participant Flow|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483969|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483970|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483971|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483972|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
483973|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483974|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483975|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483976|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483977|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483978|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483979|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483980|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
483981|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483982|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483983|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483984|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
483985|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483986|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483987|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483988|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|
483989|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483990|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483991|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483992|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
483993|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|
483994|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|
483995|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|
483996|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|All data were included in the analysis by intention to treat principle. For participants who did not complete a 12-month visit, last observation carried forward was performed for those participants for whom interim data post the baseline visit was available.
483997|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483998|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
483999|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484000|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484001|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484002|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484038|NCT00399035|B1|Baseline|Cediranib 20 mg|Cediranib 20 mg + FOLFOX/XELOX
484003|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484004|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484005|NCT00399360|O4|Outcome|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484006|NCT00399360|O3|Outcome|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484007|NCT00399360|O2|Outcome|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484008|NCT00399360|O1|Outcome|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484009|NCT00399360|E4|Reported Event|Lifestyle Modification and Metformin|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took metformin 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484010|NCT00399360|E3|Reported Event|No Lifestyle Modification and Metformin|Participants did not participate in lifestyle modification and took metformin 500mg twice daily for 3 months, this was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484011|NCT00399360|E2|Reported Event|Lifestyle Modification and Placebo|Participants participated in lifestyle modification sessions 3 times a week for the duration of the study and took a placebo capsule 500mg twice daily for 3 months which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484012|NCT00399360|E1|Reported Event|No Lifestyle Modification and Placebo|Participants did not participate in lifestyle modification and took a placebo capsule 500mg twice daily x 3 months, which was increased to 850mg twice daily at the 3 month visit for the duration of the study.
484013|NCT00399308|B4|Baseline|Total|Total of all reporting groups
484014|NCT00399308|B3|Baseline|Group III - Control|Adaptic and Profore four-layer compression dressing
484015|NCT00399308|B2|Baseline|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484016|NCT00399308|B1|Baseline|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484017|NCT00399308|P3|Participant Flow|Group III - Control|Adaptic and Profore four-layer compression dressing
484018|NCT00399308|P2|Participant Flow|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484019|NCT00399308|P1|Participant Flow|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484020|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
484021|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484022|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484023|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
484024|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484025|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484026|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
484027|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484028|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484029|NCT00399308|O3|Outcome|Group III - Control|Adaptic and Profore four-layer compression dressing
484030|NCT00399308|O2|Outcome|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484031|NCT00399308|O1|Outcome|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484032|NCT00399308|E3|Reported Event|Group III - Control|Adaptic and Profore four-layer compression dressing
484033|NCT00399308|E2|Reported Event|Group II - Bi-weekly Celaderm|Bi-weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484034|NCT00399308|E1|Reported Event|Group I - Weekly Celaderm|Weekly topical applications of Celaderm, up to a maximum of four (4) applications, in combination with Adaptic and Profore four-layer compression dressing
484035|NCT00399035|B4|Baseline|Total|Total of all reporting groups
484036|NCT00399035|B3|Baseline|Cediranib 30 mg|Cediranib 30 mg/day + FOLFOX/XELOX
484037|NCT00399035|B2|Baseline|Placebo|Placebo + FOLFOX/XELOX
484039|NCT00399035|P3|Participant Flow|Placebo|[Placebo +FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
484040|NCT00399035|P2|Participant Flow|Cediranib 30 mg/Day|[Cediranib 30mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
484041|NCT00399035|P1|Participant Flow|Cediranib 20 mg/Day|[Cediranib 20mg/day+FOLFOX/XELOX].2 FOLFOX regimens were chosen:FOLFOX4 or mFOLFOX6(repeated every 2 weeks.FOLFOX4:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 200mg/m2(or equivalent folinic acid preparation) by iv infusion over 2h on Day1 and Day2;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1 and Day2;5-FU 600 mg/m2 immediately after the 5-FU bolus dosed by continuous iv infusion over 22h on Day1 and Day2.mFOLFOX6:oxaliplatin 85mg/m2 dosed by iv infusion over 2h on Day1;leucovorin 400mg/m2(or equivalent folinic acid preparation)dosed iv over 2h on Day1;5-FU 400mg/m2 iv bolus immediately after completion of the oxaliplatin/leucovorin infusion on Day1,followed immediately by 5-FU 2400mg/m2 dosed by continuous iv infusion over 46h.XELOX:The XELOX regimen was to be repeated every 3 weeks:oxaliplatin 130mg/m2 dosed by iv infusion over 2h on Day1;capecitabine 1000mg/m2 orally twice daily on Days1 to 14.
484042|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484043|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484044|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484045|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484046|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484047|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484048|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484049|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484050|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484051|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484052|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484053|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484054|NCT00399035|O2|Outcome|Placebo|Placebo + FOLFOX/XELOX
484055|NCT00399035|O1|Outcome|Cediranib 20 mg|Cediranib 20 mg/day + FOLFOX/XELOX
484056|NCT00399035|E3|Reported Event|Placebo|Placebo + Folfox/Xelox
484057|NCT00399035|E2|Reported Event|Cediranib 20mg|Cediranib 20mg/day + Folfox/Xelox
484058|NCT00399035|E1|Reported Event|Cediranib 30mg|Cediranib 30mg/day + Folfox/Xelox
484059|NCT00398983|B3|Baseline|Total|Total of all reporting groups
484060|NCT00398983|B2|Baseline|No Study Drug|Continue current therapy.
484061|NCT00398983|B1|Baseline|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
484062|NCT00398983|P2|Participant Flow|No Study Drug|Continue current therapy.
484063|NCT00398983|P1|Participant Flow|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
484064|NCT00398983|O2|Outcome|No Study Drug|Continue current therapy.
484065|NCT00398983|O1|Outcome|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
484066|NCT00398983|E2|Reported Event|No Study Drug|Continue current therapy.
484067|NCT00398983|E1|Reported Event|Decitabine 20 mg/m^2|20 mg/m^2 intravenous (IV) daily for 5 days
484068|NCT00398918|B1|Baseline|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
484069|NCT00398918|P1|Participant Flow|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
484070|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
484071|NCT00398918|O1|Outcome|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
484072|NCT00398918|E1|Reported Event|Zonisamide-Placebo Sessions|In this within subjects study, subjects received zonisamide in one session and placebo in a second
484073|NCT00398632|B1|Baseline|Duloxetine|Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. study duration: 12 weeks
484074|NCT00398632|P1|Participant Flow|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
484075|NCT00398632|O1|Outcome|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
484127|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484128|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
484076|NCT00398632|E1|Reported Event|Duloxetine|"Duloxetine 60 mg, by mouth, once daily or twice daily (as needed to control symptoms of major depression)~Duloxetine: dosage form: capsule. dosage: 60 mg. frequency: once daily, or twice daily if 120 mg/day is needed to control symptoms of major depression. duration: 12 weeks"
484077|NCT00398411|B3|Baseline|Total|Total of all reporting groups
484078|NCT00398411|B2|Baseline|Placebo|identical appearing placebo
484079|NCT00398411|B1|Baseline|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484080|NCT00398411|P2|Participant Flow|Placebo|identical appearing placebo
484081|NCT00398411|P1|Participant Flow|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484082|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484083|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484084|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484085|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484086|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484087|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484088|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484089|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484090|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484091|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484092|NCT00398411|O2|Outcome|Placebo|identical appearing placebo
484093|NCT00398411|O1|Outcome|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484094|NCT00398411|E2|Reported Event|Placebo|identical appearing placebo
484095|NCT00398411|E1|Reported Event|Moxifloxacin|moxifloxacin 400 mg tablets once daily
484096|NCT00398398|B1|Baseline|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484097|NCT00398398|P1|Participant Flow|Xelox Plus Cetuximab|"Capecitabine, oxaliplatin and cetuximab~cetuximab : initial loading dose of 400 mg/m2, maintenance dose of 250 mg/m2 (every week) Oxaliplatin : 130 mg/m2 (every 3 weeks) capecitabine :1,000 mg/m2 (days 1–14)"
484098|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484099|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484100|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484101|NCT00398398|O1|Outcome|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484102|NCT00398398|E1|Reported Event|Xelox Plus Cetuximab|Capecitabine, oxaliplatin and cetuximab
484103|NCT00398320|B1|Baseline|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484104|NCT00398320|P1|Participant Flow|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484105|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484106|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484107|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484108|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484109|NCT00398320|O1|Outcome|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484110|NCT00398320|E1|Reported Event|Capecitabine / Oxaliplatin / Bevacizumab|"Oxaliplatin: 130 mg/m2 intravenously on day 1 of a 21 day cycle~Capecitabine: 850 mg/m2 by mouth twice a day for days 1-14 on a 21 day cycle~Bevacizumab: 7.5mg/kg intravenously on day 1 of a 21 day cycle~AEs reported are related and grade 3 or higher per CTCAE verion 3."
484111|NCT00398216|B6|Baseline|Total|Total of all reporting groups
484112|NCT00398216|B5|Baseline|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484113|NCT00398216|B4|Baseline|Edoxaban 90mg QD|edoxaban 90mg QD PO
484114|NCT00398216|B3|Baseline|Edoxaban 60mg QD|edoxaban 60mg QD PO
484115|NCT00398216|B2|Baseline|Edoxaban 30mg QD|edoxaban 30mg QD PO
484116|NCT00398216|B1|Baseline|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484117|NCT00398216|P5|Participant Flow|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484118|NCT00398216|P4|Participant Flow|Edoxaban 90mg QD|edoxaban 90mg QD PO
484119|NCT00398216|P3|Participant Flow|Edoxaban 60mg QD|edoxaban 60mg QD PO
484120|NCT00398216|P2|Participant Flow|Edoxaban 30mg QD|edoxaban 30mg QD PO
484121|NCT00398216|P1|Participant Flow|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484122|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484123|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
484124|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
484125|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
484126|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484129|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
484130|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
484131|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484132|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484133|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
484134|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
484135|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
484136|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484137|NCT00398216|O5|Outcome|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484138|NCT00398216|O4|Outcome|Edoxaban 90mg QD|edoxaban 90mg QD PO
484139|NCT00398216|O3|Outcome|Edoxaban 60mg QD|edoxaban 60mg QD PO
484140|NCT00398216|O2|Outcome|Edoxaban 30mg QD|edoxaban 30mg QD PO
484141|NCT00398216|O1|Outcome|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484142|NCT00398216|E5|Reported Event|Dalteparin|dalteparin 2500 IU/mL initial dose followed by 5000 IU once daily subcutaneously
484143|NCT00398216|E4|Reported Event|Edoxaban 90mg QD|edoxaban 90mg QD PO
484144|NCT00398216|E3|Reported Event|Edoxaban 60mg QD|edoxaban 60mg QD PO
484145|NCT00398216|E2|Reported Event|Edoxaban 30mg QD|edoxaban 30mg QD PO
484146|NCT00398216|E1|Reported Event|Edoxaban 15mg QD|edoxaban 15mg QD (once daily) orally (PO)
484147|NCT00398138|B1|Baseline|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
484148|NCT00398138|P1|Participant Flow|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
484149|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
484150|NCT00398138|O1|Outcome|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
484151|NCT00398138|E1|Reported Event|Vaccine|"Six vaccinations of the WT-1 peptide (1.0 ml of emulsion) will be administered on weeks 0, 4, 6, 8, 10 & 12. Vaccinations will be administered subcutaneously with sites rotated among extremities. Injection sites will be pre-stimulated with Sargramostim (GM-CSF) (70 mcg) injected subcutaneously on days 0 & -2 of each vaccination. Patients may self administer the Sargramostim (GM-CSF) if they have been appropriately instructed on SQ injection administration. Patients will keep a logbook noting the time & placement of the injection. Note: during each vaccination, the Sargramostim (GM-CSF) & the vaccine emulsion will be administered to the same anatomical site. This site will be marked by the patient or treating healthcare professional by a permanent marker pen. For patients who have a clinical, molecular, or immunologic response & have not had disease progression, they may receive up to 6 more vaccinations administered approximately every month.~WT-1 analog peptide vaccine"
484152|NCT00398112|B1|Baseline|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484153|NCT00398112|P1|Participant Flow|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484154|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484205|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484155|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484156|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484157|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484158|NCT00398112|O1|Outcome|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484159|NCT00398112|E1|Reported Event|Sunitinib Malate|Patients receive oral sunitinib malate 37.5 mg daily on days 1-28. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
484160|NCT00398086|B4|Baseline|Total|Total of all reporting groups
484161|NCT00398086|B3|Baseline|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484162|NCT00398086|B2|Baseline|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484163|NCT00398086|B1|Baseline|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484164|NCT00398086|P3|Participant Flow|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484165|NCT00398086|P2|Participant Flow|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484166|NCT00398086|P1|Participant Flow|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484167|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484168|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484169|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484170|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484171|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484172|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484173|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484174|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484175|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484176|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484177|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484178|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484179|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484180|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484835|NCT00395850|B2|Baseline|Disulfiram 250|disulfiram at 250 mg/day
484181|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484182|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484183|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484184|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484185|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484186|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484187|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484188|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484189|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484190|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484191|NCT00398086|O3|Outcome|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484192|NCT00398086|O2|Outcome|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484193|NCT00398086|O1|Outcome|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484194|NCT00398086|E3|Reported Event|150 mg/m^2|Participants received albumin-bound paclitaxel 150 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level three). Treatment continued until progressive disease or unacceptable toxicity.
484195|NCT00398086|E2|Reported Event|125 mg/m^2|Participants received albumin-bound paclitaxel 125 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level two). Treatment continued until progressive disease or unacceptable toxicity.
484196|NCT00398086|E1|Reported Event|100 mg/m^2|Participants received albumin-bound paclitaxel 100 mg/m^2 followed by gemcitabine 1000 mg/m^2 by intravenous infusion (IV) on Days 1, 8 and 15 of each 28 day cycle (dose level one). Treatment continued until progressive disease or unacceptable toxicity.
484197|NCT00398047|B1|Baseline|Azacitidine and Darbopoietin and G-CSF|
484198|NCT00398047|P1|Participant Flow|Combination of Azacitadine and Hematopoietic Growth Factors|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
484199|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484200|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484201|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484202|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484203|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|
484204|NCT00398047|O1|Outcome|Azacitidine and Darbopoietin and G-CSF|azacitidine 100 miligrams/meter squares subcutaneous for 5 days every 28 day cycle,o If the patient had a major hematological improvement; or the patient had grade 3 or 4 hematological toxicities during the first two cycles, and/or there is >=50% reduction in bone marrow cellularity compared to the baseline bone marrow, filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogram) subcutaneous three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8. Patients not meeting the above criteria will have a dose escalation of azacitidine to 125 miligrams/meter subcutaneous for 5 days, beginning on day 57 with growth factor support and filgastrim will be administered at dose of 300 µg (if weight is less then 100 kilogram) or 450 µg (if weight is ≥100 kilogra,) sq three times a week on week 2, 3, 4 along with darbopoietin 500 µg subcutaneous on day 8).
484206|NCT00398047|E1|Reported Event|Azacitidine and Darbopoietin and G-CSF|
484207|NCT00397930|B3|Baseline|Total|Total of all reporting groups
484208|NCT00397930|B2|Baseline|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
484209|NCT00397930|B1|Baseline|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
484210|NCT00397930|P2|Participant Flow|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
484211|NCT00397930|P1|Participant Flow|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
484212|NCT00397930|O2|Outcome|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
484213|NCT00397930|O1|Outcome|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
484214|NCT00397930|E2|Reported Event|Standard Care Control Condition|"The control condition used a standard care format. Cancer survivors assigned to this condition continued with the standard follow-up care provided by their treating oncologists as appropriate for individual diagnoses. Participants in the control condition were offered the 4-week YOCAS program gratis after completing all study requirements.~fatigue assessment and management~management of therapy complications~quality-of-life assessment"
484215|NCT00397930|E1|Reported Event|Yoga Intervention (YOCAS)|"The yoga intervention used the standardized Yoga for Cancer Survivors (YOCAS) program, designed by researchers at the University of Rochester Medical Center. All sessions were taught in community-based sites (eg. yoga studios, community centers, community oncology practices) with an average group size of 12 (range, 10-15) in the late afternoon or evening after 4pm.~fatigue assessment and management~management of therapy complications~quality-of-life assessment~sleep disorder therapy~yoga therapy"
484216|NCT00397904|B1|Baseline|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
484217|NCT00397904|P1|Participant Flow|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
484218|NCT00397904|O1|Outcome|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
484219|NCT00397904|E1|Reported Event|Cetuximab, Cisplatin, and Irinotecan|Cetuximab will be combined with weekly irinotecan and cisplatin. Patients will receive cetuximab 400 mg/m2 on day 1, week 1. Following this loading dose, patients will receive weekly cetuximab 250 mg/m2 (day 8, 15, 22, etc.) until disease progression or unacceptable toxicity. Patients will continue to receive irinotecan and cisplatin weekly on day 1 and day 8, on an every 21 day cycle. The standard maximum doses are irinotecan 65 mg/m2 and cisplatin 30 mg/m2.
484220|NCT00397891|B6|Baseline|Total|Total of all reporting groups
484221|NCT00397891|B5|Baseline|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484222|NCT00397891|B4|Baseline|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484223|NCT00397891|B3|Baseline|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484224|NCT00397891|B2|Baseline|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484225|NCT00397891|B1|Baseline|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484226|NCT00397891|P5|Participant Flow|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484227|NCT00397891|P4|Participant Flow|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484228|NCT00397891|P3|Participant Flow|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484229|NCT00397891|P2|Participant Flow|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484230|NCT00397891|P1|Participant Flow|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484231|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484232|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484233|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484234|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484235|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484236|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484237|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484238|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484239|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484240|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484241|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484242|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484243|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484244|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484245|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484246|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484247|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484248|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484249|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484250|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484251|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484252|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484253|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484254|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484255|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484256|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484257|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484258|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484259|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484260|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484261|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484262|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484263|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484264|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484265|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484266|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484267|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484268|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484269|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484270|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484271|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484272|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484273|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484274|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484275|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484276|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484277|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484278|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484279|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484280|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484281|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484282|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484283|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484284|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484285|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484286|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484287|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484288|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484289|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484290|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484291|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484292|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484293|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484294|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484295|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484296|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484297|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484298|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484299|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484300|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484301|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484302|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484303|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484304|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484305|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484306|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484307|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484308|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484309|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484310|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484311|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484312|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484313|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484314|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484315|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484316|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484317|NCT00397891|O5|Outcome|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484318|NCT00397891|O4|Outcome|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484319|NCT00397891|O3|Outcome|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484320|NCT00397891|O2|Outcome|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484321|NCT00397891|O1|Outcome|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484322|NCT00397891|E5|Reported Event|Placebo|Single dose of placebo matched to bapineuzumab intravenous infusion over 1 hour on Day 1.
484323|NCT00397891|E4|Reported Event|Bapineuzumab 2.0 mg/kg|Single dose of bapineuzumab 2.0 mg/kg intravenous infusion over 1 hour on Day 1.
484324|NCT00397891|E3|Reported Event|Bapineuzumab 1.0 mg/kg|Single dose of bapineuzumab 1.0 mg/kg intravenous infusion over 1 hour on Day 1.
484325|NCT00397891|E2|Reported Event|Bapineuzumab 0.5 mg/kg|Single dose of bapineuzumab 0.5 mg/kg intravenous infusion over 1 hour on Day 1.
484326|NCT00397891|E1|Reported Event|Bapineuzumab 0.15 mg/kg|Single dose of bapineuzumab (AAB-001) 0.15 milligram per kilogram (mg/kg) intravenous infusion over 1 hour on Day 1.
484327|NCT00397878|B1|Baseline|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
484328|NCT00397878|P1|Participant Flow|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
484329|NCT00397878|O1|Outcome|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
484330|NCT00397878|E1|Reported Event|Treatment (Saracatinib)|Oral AZD0530 175 mg once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
484331|NCT00397839|B3|Baseline|Total|Total of all reporting groups
484332|NCT00397839|B2|Baseline|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484333|NCT00397839|B1|Baseline|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484334|NCT00397839|P2|Participant Flow|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484335|NCT00397839|P1|Participant Flow|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484336|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484337|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484338|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484339|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484340|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484341|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484342|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484343|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484344|NCT00397839|O2|Outcome|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484345|NCT00397839|O1|Outcome|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484346|NCT00397839|E2|Reported Event|Ibandronate|Ibandronate orally at a dose of 150 mg once a month for 12 months
484347|NCT00397839|E1|Reported Event|Placebo|Placebo orally at a dose of 150 mg once a month for 12 months
484348|NCT00397631|B3|Baseline|Total|Total of all reporting groups
484349|NCT00397631|B2|Baseline|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484350|NCT00397631|B1|Baseline|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484351|NCT00397631|P2|Participant Flow|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484352|NCT00397631|P1|Participant Flow|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484353|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484354|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484355|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484356|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484357|NCT00397631|O2|Outcome|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484358|NCT00397631|O1|Outcome|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484359|NCT00397631|E2|Reported Event|Pioglitazone 30 mg q.d.|The Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of pioglitazone 30 mg oral tablets and placebo to sitagliptin 100 mg oral tablets administered once daily.
484565|NCT00397189|O2|Outcome|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
484836|NCT00395850|B1|Baseline|Placebo|microcrystalline cellulose
484360|NCT00397631|E1|Reported Event|Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d.|The Sitagliptin 100 mg q.d. + Pioglitazone 30 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive coadministration of sitagliptin 100 mg oral tablets and pioglitazone 30 mg oral tablets administered once daily.
484361|NCT00397540|B3|Baseline|Total|Total of all reporting groups
484362|NCT00397540|B2|Baseline|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
484363|NCT00397540|B1|Baseline|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
484364|NCT00397540|P2|Participant Flow|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
484365|NCT00397540|P1|Participant Flow|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
484366|NCT00397540|O2|Outcome|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
484367|NCT00397540|O1|Outcome|PEIT|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
484368|NCT00397540|E2|Reported Event|RFTA|high ultrasonic wave energy applied using standard radiofrequence thermal ablation (RFTA) intervention technique by incurring coagulation necrosis. Each procedure usually comprises only one session.
484369|NCT00397540|E1|Reported Event|Percutaneous Ethanol Injection Therapy|99% of ethanol injected using standard percutaneous ethanol injection therapy (PEIT) intervention technique under the guidance of ultrasonography. Each procedure usually comprises 2 to 3 sessions.
484370|NCT00397514|B1|Baseline|Congenital Heart Disease Patients|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
484371|NCT00397514|P1|Participant Flow|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
484372|NCT00397514|O1|Outcome|Congenital Heart Disease Pts. Undergoing Biventricular Repair|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
484373|NCT00397514|O3|Outcome|RV Pacing|QRS duration when patient's extubation with 20 min. of right ventricular pacing
484374|NCT00397514|O2|Outcome|BiV Pacing|QRS duration when patient's extubation with 20 min. of biventricular pacing
484375|NCT00397514|O1|Outcome|Baseline|QRS duration at baseline
484376|NCT00397514|O3|Outcome|RV Pacing|Cardiac Index when patient's extubation with 20 min. of right ventricular pacing
484377|NCT00397514|O2|Outcome|BiV Pacing|Cardiac Index when patient's extubation with 20 min. of biventricular pacing
484378|NCT00397514|O1|Outcome|Baseline|Cardiac Index at baseline.
484379|NCT00397514|E1|Reported Event|Pacing Protocol and RV Pacing|Pacing protocol prior to patient's extubation with 20 min. of conventional right ventricular (RV), preceded and followed by 10 min. of recovery time.
484380|NCT00397488|B1|Baseline|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
484381|NCT00397488|P1|Participant Flow|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
484382|NCT00397488|O1|Outcome|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
484383|NCT00397488|E1|Reported Event|Sunitinib|Sunitinib in patients with metastatic urothelial carcinoma.
484384|NCT00397462|B4|Baseline|Total|Total of all reporting groups
484385|NCT00397462|B3|Baseline|Control|No use of the intervention
484386|NCT00397462|B2|Baseline|Group 2 High Use|requested that they use the intervention as much as possible during the work day
484387|NCT00397462|B1|Baseline|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
484388|NCT00397462|P3|Participant Flow|Control|No intervention
484389|NCT00397462|P2|Participant Flow|Group 2 High Use|requested that they use the intervention as much as possible during the work day
484390|NCT00397462|P1|Participant Flow|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
484391|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
484392|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
484393|NCT00397462|O1|Outcome|Control|No change to usual behavior
484394|NCT00397462|O3|Outcome|High Dose|"Request that calf muscle pump stimulation be used at least four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
484395|NCT00397462|O2|Outcome|Low Dose|"Request that calf muscle pump stimulation be used less than four hours per day~calf muscle pump stimulation: Micromechanical stimulation of the postural reflex arc to activate the soleus muscle to enhance lower limb fluid return to the heart"
484396|NCT00397462|O1|Outcome|Control|No change to usual behavior
484397|NCT00397462|E3|Reported Event|Control|did not use the intervention
484398|NCT00397462|E2|Reported Event|Group 2 High Use|requested that they use the intervention as much as possible during the work day
484399|NCT00397462|E1|Reported Event|Group 1 Low Use|requested that they use the intervention during only the morning or afternoon up to 4 hours
484400|NCT00397254|B1|Baseline|Baseline Period - Rizatriptan 9 Tablets|Prior to randomization at Visit 2 (to rizatriptan 9 tablets or rizatriptan 27 tablets), all subjects in Baseline were provided with 9 tablets of rizatriptan.
484401|NCT00397254|P2|Participant Flow|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484402|NCT00397254|P1|Participant Flow|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484403|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484404|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484405|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484406|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484407|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484408|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484409|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484410|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484411|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484412|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484413|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484414|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484415|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484416|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484417|NCT00397254|O2|Outcome|Rizatriptan 9 Tablets - Formulary Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a formulary limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 9 tablets per month."
484418|NCT00397254|O1|Outcome|Rizatriptan 27 Tablets - Clinical Limit|"Eligible patients were randomized to one of two treatment regimens in a 1:1 ratio. Those randomized to receive a clinical limit of study medication received Rizatriptan 10mg orally disintegrating tablet (ODT): 27 tablets per month."
484419|NCT00397215|B5|Baseline|Total|Total of all reporting groups
484420|NCT00397215|B4|Baseline|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484421|NCT00397215|B3|Baseline|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484422|NCT00397215|B2|Baseline|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484423|NCT00397215|B1|Baseline|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484424|NCT00397215|P4|Participant Flow|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484425|NCT00397215|P3|Participant Flow|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484566|NCT00397189|O1|Outcome|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
484426|NCT00397215|P2|Participant Flow|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484427|NCT00397215|P1|Participant Flow|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484428|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484429|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484430|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484431|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484432|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484433|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484434|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484435|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484436|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484437|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484438|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484439|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484440|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484441|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484442|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484443|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484444|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484445|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484446|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484447|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484448|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484449|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484450|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484451|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484452|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484453|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484454|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484455|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484456|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484457|NCT00397215|O3|Outcome|GSK1562902A 3 Group|GSK1562902A 3 Group Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484458|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484459|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484460|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484461|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484462|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484463|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484464|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484465|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484466|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484467|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484468|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484469|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484470|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484471|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484472|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484473|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484474|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484475|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484476|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484477|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484478|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484479|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484480|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484567|NCT00397189|E2|Reported Event|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
484481|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484482|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484483|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484484|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484485|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484486|NCT00397215|O2|Outcome|GSK1562902A 2 Group|GSK1562902A 2 Group Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484487|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484488|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484489|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484490|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484491|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484492|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484493|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484494|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484495|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484496|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484497|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484498|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484499|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484500|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484501|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484502|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484503|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484504|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484505|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484506|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484507|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484568|NCT00397189|E1|Reported Event|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
484569|NCT00397150|B3|Baseline|Total|Total of all reporting groups
484508|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484509|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484510|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484511|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484512|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484513|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484514|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484515|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484516|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484517|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484518|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484519|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484520|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484521|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484522|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484523|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484524|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484525|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484526|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484527|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484528|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484529|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484530|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484531|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484532|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484533|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484534|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484570|NCT00397150|B2|Baseline|No Intervention|Standard of care
484571|NCT00397150|B1|Baseline|Intervention|Peer-counselling for exclusive breastfeeding
484535|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484536|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484537|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484538|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484539|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484540|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484541|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484542|NCT00397215|O2|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484543|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484544|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484545|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484546|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484547|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484548|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484549|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484550|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484551|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484552|NCT00397215|O4|Outcome|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484553|NCT00397215|O3|Outcome|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484554|NCT00397215|O2|Outcome|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484555|NCT00397215|O1|Outcome|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484556|NCT00397215|E4|Reported Event|GSK1562902A 4 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484557|NCT00397215|E3|Reported Event|GSK1562902A 3 Group|Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in deltoid region of each arm.
484558|NCT00397215|E2|Reported Event|GSK1562902A 2 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484559|NCT00397215|E1|Reported Event|GSK1562902A 1 Group|Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.
484560|NCT00397189|B3|Baseline|Total|Total of all reporting groups
484561|NCT00397189|B2|Baseline|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
484562|NCT00397189|B1|Baseline|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
484563|NCT00397189|P2|Participant Flow|Placebo|Identical tablets to Circadin. Tablets should be taken 1-2 hours before going to bed.
484564|NCT00397189|P1|Participant Flow|Circadin|Prolonged release melatonin 2 mg. Tablets should be taken 1-2 hours before going to bed.
484572|NCT00397150|P2|Participant Flow|No Intervention|Standard of care
484573|NCT00397150|P1|Participant Flow|Intervention|Peer-counselling for exclusive breastfeeding
484574|NCT00397150|O2|Outcome|No Intervention|Standard of care
484575|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
484576|NCT00397150|O2|Outcome|No Intervention|Standard of care
484577|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
484578|NCT00397150|O2|Outcome|No Intervention|Standard of care
484579|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
484580|NCT00397150|O2|Outcome|No Intervention|Standard of care
484581|NCT00397150|O1|Outcome|Intervention|Peer-counselling for exclusive breastfeeding
484582|NCT00397150|E2|Reported Event|Standard of Care|
484583|NCT00397150|E1|Reported Event|Peer Counselling for Exclusive Breastfeeding|
484584|NCT00397033|B4|Baseline|Total|Total of all reporting groups
484585|NCT00397033|B3|Baseline|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484586|NCT00397033|B2|Baseline|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484587|NCT00397033|B1|Baseline|Placebo|
484588|NCT00397033|P3|Participant Flow|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484589|NCT00397033|P2|Participant Flow|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484590|NCT00397033|P1|Participant Flow|Placebo|
484591|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484592|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484593|NCT00397033|O1|Outcome|Placebo|
484594|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484595|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484596|NCT00397033|O1|Outcome|Placebo|
484597|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484598|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484599|NCT00397033|O1|Outcome|Placebo|
484600|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484601|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484602|NCT00397033|O1|Outcome|Placebo|
484603|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484604|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484605|NCT00397033|O1|Outcome|Placebo|
484606|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484607|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484608|NCT00397033|O1|Outcome|Placebo|
484609|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484610|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484611|NCT00397033|O1|Outcome|Placebo|
484612|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484613|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484614|NCT00397033|O1|Outcome|Placebo|
484615|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484616|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484617|NCT00397033|O1|Outcome|Placebo|
484618|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484619|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484620|NCT00397033|O1|Outcome|Placebo|
484621|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484622|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484623|NCT00397033|O1|Outcome|Placebo|
484624|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484625|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484626|NCT00397033|O1|Outcome|Placebo|
484627|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484628|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484629|NCT00397033|O1|Outcome|Placebo|
484816|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484630|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484631|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484632|NCT00397033|O1|Outcome|Placebo|
484633|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484634|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484635|NCT00397033|O1|Outcome|Placebo|
484636|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484637|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484638|NCT00397033|O1|Outcome|Placebo|
484639|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484640|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484641|NCT00397033|O1|Outcome|Placebo|
484642|NCT00397033|O3|Outcome|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484643|NCT00397033|O2|Outcome|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484644|NCT00397033|O1|Outcome|Placebo|
484645|NCT00397033|E3|Reported Event|Paliperidone Extended Release (ER) High Dose|Paliperidone Extended Release (ER) High Dose - 12mg/day with option to reduce to 9mg/day
484646|NCT00397033|E2|Reported Event|Paliperidone Extended Release (ER) Low Dose|Paliperidone Extended Release (ER) Low Dose - 6mg/day with option to reduce to 3mg/day
484647|NCT00397033|E1|Reported Event|Placebo|
484648|NCT00396981|B3|Baseline|Total|Total of all reporting groups
484649|NCT00396981|B2|Baseline|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
484650|NCT00396981|B1|Baseline|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
484651|NCT00396981|P2|Participant Flow|GDC® Coils for Endovascular Aneurysm Occlusion|"GDC® Coils for endovascular aneurysm occlusion~GDC® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
484652|NCT00396981|P1|Participant Flow|Matrix 2® Coils for Endovascular Aneurysm Occlusion|"Matrix 2® Coils for endovascular aneurysm occlusion~Matrix 2® coils for endovascular aneurysm occlusion : endovascular aneurysm occlusion coil"
484653|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484654|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484655|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484656|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484657|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484658|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484659|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484660|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484661|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484662|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484663|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484664|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484665|NCT00396981|O2|Outcome|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484666|NCT00396981|O1|Outcome|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484667|NCT00396981|E2|Reported Event|GDC Coils|GDC® Coils for endovascular aneurysm occlusion
484668|NCT00396981|E1|Reported Event|Matrix Coils|Matrix 2® Coils for endovascular aneurysm occlusion
484669|NCT00396877|B3|Baseline|Total|Total of all reporting groups
484670|NCT00396877|B2|Baseline|Clopidogrel 0.2 mg/kg/Day|
484671|NCT00396877|B1|Baseline|Placebo|
484672|NCT00396877|P2|Participant Flow|Clopidogrel 0.2 mg/kg/Day|"Reconstituted solution using Clopidogrel powder administered once daily with a graduated syringe in the mouth or via a feeding tube.~Route: oral or enteric~Frequency: once daily~Dose: daily dose adjusted for weight"
484673|NCT00396877|P1|Participant Flow|Placebo|Reconstituted solution using Clopidogrel matching placebo powder administered once daily with a graduated syringe in the mouth or via a feeding tube.
484674|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
484675|NCT00396877|O1|Outcome|Placebo|
484676|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
484677|NCT00396877|O1|Outcome|Placebo|
484678|NCT00396877|O2|Outcome|Clopidogrel 0.2 mg/kg/Day|
484679|NCT00396877|O1|Outcome|Placebo|
484680|NCT00396877|E2|Reported Event|Clopidogrel 0.2mg/kg/Day|
484681|NCT00396877|E1|Reported Event|Placebo|
484682|NCT00396812|B1|Baseline|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484683|NCT00396812|P1|Participant Flow|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484817|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484818|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484684|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484685|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484686|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484687|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484688|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484689|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484690|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484691|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484692|NCT00396812|O1|Outcome|Rituximab|"Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2.~Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid."
484693|NCT00396812|E1|Reported Event|Rituximab|Participants to receive an intravenous infusion of rituximab (1 gram ) fourteen days apart, at baseline (Day 0) and at Week 2. Concomitant treatments to be administered at a dose and frequency prescribed per protocol include methotrexate (MTX) and folic or folinic acid.
484694|NCT00396656|B1|Baseline|Entire Study Population|Includes patients that received valsartan followed by atenolol + hydrochlorothiazide and patients that received atenolol + hydrochlorothiazide followed by valsartan.
484695|NCT00396656|P2|Participant Flow|Atenolol + Hydrochlorothiazide (HCTZ) Followed by Valsartan|"After a 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks followed by one week in which atenolol was tapered off and HCTZ was discontinued. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with valsartan for 20 weeks. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. Patients took valsartan film coated tablets orally once a day (od) in the morning"
484696|NCT00396656|P1|Participant Flow|Valsartan Followed by Atenolol + Hydrochlorothiazide (HCTZ)|"After a 2-week washout period, patients were treated with valsartan for 20 weeks followed by one week in which it was tapered off. Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.~After a second 2-week washout period, patients were treated with atenolol plus HCTZ for 20 weeks. Patients received atenolol 100 mg for 20 weeks. Patients took atenolol tablets orally once a day (od) in the morning. Patients received HCTZ 12.5 mg for 4 weeks starting at the beginning of the 5th week and then received 25 mg for 12 weeks. Patients took HCTZ tablets orally once a day (od) in the morning."
484697|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484698|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484699|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484700|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484701|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484819|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484820|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484821|NCT00395863|O3|Outcome|Reader 3|
484702|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484703|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484704|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484705|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484706|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484707|NCT00396656|O2|Outcome|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484708|NCT00396656|O1|Outcome|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484709|NCT00396656|E2|Reported Event|Atenolol + Hydrochlorothiazide|Patients received atenolol 100 mg for 19 weeks. In the last week of this intervention, the atenolol dose was reduced to 50 mg. Patients took atenolol tablets orally once a day (od) in the morning. Patients received hydrochlorothiazide 100 mg for 15 weeks starting at the beginning of the 5th week of this intervention. In the last week of this intervention, the hydrochlorothiazide dose was increased to 25 mg. Patients took hydrochlorothiazide tablets orally once a day (od) in the morning.
484710|NCT00396656|E1|Reported Event|Valsartan|Patients received valsartan 160 mg for 4 weeks, followed by valsartan 320 mg for 16 weeks. The valsartan dose was then tapered off to 80 mg for one week. Patients took valsartan film coated tablets orally once a day (od) in the morning.
484711|NCT00396630|B3|Baseline|Total|Total of all reporting groups
484712|NCT00396630|B2|Baseline|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484713|NCT00396630|B1|Baseline|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484714|NCT00396630|P2|Participant Flow|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484715|NCT00396630|P1|Participant Flow|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484716|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484717|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484718|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484719|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484720|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484721|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484722|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484723|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484724|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484725|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484822|NCT00395863|O2|Outcome|Reader 2|
484823|NCT00395863|O1|Outcome|Reader 1|
484824|NCT00395863|O3|Outcome|Reader 3|
484726|NCT00396630|O2|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484727|NCT00396630|O1|Outcome|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484728|NCT00396630|O1|Outcome|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484729|NCT00396630|E2|Reported Event|Placebo Group|"All subjects received 2 oral doses of placebo at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484730|NCT00396630|E1|Reported Event|Rotarix Group|"All subjects received 2 oral doses of Rotarix vaccine at Day 0 (Visit 1) and Week 7 (Visit 2).~Subjects aged less than 6 months at Visit 3 received one complimentary Rotarix vaccine dose at Week 13 (Visit 3)."
484731|NCT00396591|B1|Baseline|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484732|NCT00396591|P1|Participant Flow|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484733|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484734|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484735|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484736|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484737|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484738|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484739|NCT00396591|O1|Outcome|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484740|NCT00396591|E1|Reported Event|Aflibercept|Participants with advanced ovarian epithelial cancer treated with 4.0 mg/kg Aflibercept every 2 weeks until a criterion for treatment discontinuation was met
484741|NCT00396565|B4|Baseline|Total|Total of all reporting groups
484742|NCT00396565|B3|Baseline|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484743|NCT00396565|B2|Baseline|Placebo|Two placebo tablets once daily for 6 weeks
484744|NCT00396565|B1|Baseline|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484745|NCT00396565|P3|Participant Flow|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484746|NCT00396565|P2|Participant Flow|Placebo|Two placebo tablets once daily for 6 weeks
484747|NCT00396565|P1|Participant Flow|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484748|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484749|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484750|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484751|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484752|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484753|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484754|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484755|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484756|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484757|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484758|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484759|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484760|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484761|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484762|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484763|NCT00396565|O3|Outcome|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484764|NCT00396565|O2|Outcome|Placebo|Two placebo tablets once daily for 6 weeks
484765|NCT00396565|O1|Outcome|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484766|NCT00396565|E3|Reported Event|Olanzapine|Four olanzapine 2.5 mg tablets once daily for 6 weeks
484767|NCT00396565|E2|Reported Event|Placebo|Two placebo tablets once daily for 6 weeks
484768|NCT00396565|E1|Reported Event|Paliperidone Extended Release (ER) (JNS007ER)|Two paliperidone ER (JNS007ER) 3 mg tablets once daily for 6 weeks
484769|NCT00395876|B3|Baseline|Total|Total of all reporting groups
484825|NCT00395863|O2|Outcome|Reader 2|
484826|NCT00395863|O1|Outcome|Reader 1|
484827|NCT00395863|O3|Outcome|Reader 3|
484828|NCT00395863|O2|Outcome|Reader 2|
484829|NCT00395863|O1|Outcome|Reader 1|
484830|NCT00395863|E2|Reported Event|Magnevist|Adverse events experienced by patients occurred relative to the administration of Magnevist.
484770|NCT00395876|B2|Baseline|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484771|NCT00395876|B1|Baseline|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484772|NCT00395876|P2|Participant Flow|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484773|NCT00395876|P1|Participant Flow|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484774|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484775|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484776|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484777|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484778|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484779|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484831|NCT00395863|E1|Reported Event|MultiHance|Adverse events experienced by patients occurred relative to the administration of MultiHance.
484832|NCT00395850|B5|Baseline|Total|Total of all reporting groups
484780|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484781|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484782|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484783|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484784|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484785|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484786|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484787|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484788|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484789|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484833|NCT00395850|B4|Baseline|Disulfiram 500|Disulfiram at 500 mg/day
484834|NCT00395850|B3|Baseline|Disulfiram 375|Disulfiram at 375 mg/day
484790|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484791|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484792|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484793|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484794|NCT00395876|O2|Outcome|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484795|NCT00395876|O1|Outcome|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484796|NCT00395876|E2|Reported Event|Tenecteplase + Tenecteplase + Placebo (TTP)|"Initial dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function not restored, patient received third dose: 2 mL of placebo instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484797|NCT00395876|E1|Reported Event|Placebo + Tenecteplase + Tenecteplase (PTT)|"Initial dose: 2 mL of placebo instilled into lumen of dysfunctional central venous cathether (CVC).~If CVC function was not restored, patient received second dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~If CVC function was not restored, patient received third dose: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.~Restoration of CVC function was defined as the successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg."
484798|NCT00395863|B3|Baseline|Total|Total of all reporting groups
484799|NCT00395863|B2|Baseline|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
484800|NCT00395863|B1|Baseline|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
484801|NCT00395863|P2|Participant Flow|Magnevist, Then MultiHance|0.1 mmol/kg injection of each product
484802|NCT00395863|P1|Participant Flow|MultiHance, Then Magnevist|0.1 mmol/kg injection of each product
484803|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484804|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484805|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484806|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484807|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484808|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484809|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484810|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484811|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484812|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484813|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484814|NCT00395863|O1|Outcome|MultiHance|0.1 mmol/kg injection
484815|NCT00395863|O2|Outcome|Magnevist|0.1 mmol/kg injection
484837|NCT00395850|P4|Participant Flow|Disulfiram 500|Disulfiram at 500 mg/day
484838|NCT00395850|P3|Participant Flow|Disulfiram 375|Disulfiram at 375 mg/day
484839|NCT00395850|P2|Participant Flow|Disulfiram 250|disulfiram at 250 mg/day
484840|NCT00395850|P1|Participant Flow|Placebo|microcrystalline cellulose
484841|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
484842|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
484843|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
484844|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
484845|NCT00395850|O4|Outcome|Disulfiram 500|Disulfiram at 500 mg/day
484846|NCT00395850|O3|Outcome|Disulfiram 375|Disulfiram at 375 mg/day
484847|NCT00395850|O2|Outcome|Disulfiram 250|disulfiram at 250 mg/day
484848|NCT00395850|O1|Outcome|Placebo|microcrystalline cellulose
484849|NCT00395850|E4|Reported Event|Disulfiram 500|Disulfiram at 500 mg/day
484850|NCT00395850|E3|Reported Event|Disulfiram 375|Disulfiram at 375 mg/day
484851|NCT00395850|E2|Reported Event|Disulfiram 250|disulfiram at 250 mg/day
484852|NCT00395850|E1|Reported Event|Placebo|microcrystalline cellulose
484853|NCT00395746|B4|Baseline|Total|Total of all reporting groups
484854|NCT00395746|B3|Baseline|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484855|NCT00395746|B2|Baseline|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484856|NCT00395746|B1|Baseline|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484857|NCT00395746|P3|Participant Flow|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484858|NCT00395746|P2|Participant Flow|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484859|NCT00395746|P1|Participant Flow|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484860|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484861|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484862|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484863|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484864|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484865|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484866|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484867|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484868|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484869|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484870|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484871|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484872|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484873|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484874|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484875|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484876|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484877|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484878|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484879|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484880|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484881|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484882|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484883|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484884|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484885|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
485212|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
484886|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484887|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484888|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484889|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484890|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484891|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484892|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484893|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484894|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484895|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484896|NCT00395746|O3|Outcome|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484897|NCT00395746|O2|Outcome|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484898|NCT00395746|O1|Outcome|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484899|NCT00395746|E3|Reported Event|SU Mono|Liraglutide placebo (0.6 mg/day or 0.9 mg/day) in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484900|NCT00395746|E2|Reported Event|0.9 mg + SU|Liraglutide 0.9 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484901|NCT00395746|E1|Reported Event|0.6 mg + SU|Liraglutide 0.6 mg/day in addition to subject's own sulphonylurea (glibenclamide, gliclazide or glimepiride) treatment
484902|NCT00395733|B3|Baseline|Total|Total of all reporting groups
484903|NCT00395733|B2|Baseline|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
484904|NCT00395733|B1|Baseline|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
484905|NCT00395733|P2|Participant Flow|Period 1: Gadopentate Dimeglumine, Period 2: Gadobutrol|Period 1: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadobutrol 0.2 - 0.3 mmol/kg BW (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
484906|NCT00395733|P1|Participant Flow|Period 1: Gadobutrol, Period 2: Gadopentate Dimeglumine|Period 1: Gadobutrol 0.2 - 0.3 mmol/kg Body Weight (BW) (Gadavist, BAY86-4875); Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW). Period 2: Gadopentate dimeglumine 0.2 - 0.3 mmol/kg BW (Magnevist, BAY86-4882); Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW).
484907|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484908|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484909|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484910|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484911|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484912|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484913|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
485549|NCT00395486|O1|Outcome|Rosuvastatin|10mg
484914|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484915|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484916|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484917|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484918|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484919|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484920|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484921|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484922|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484923|NCT00395733|O2|Outcome|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484924|NCT00395733|O1|Outcome|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484925|NCT00395733|E2|Reported Event|Gadopentate Dimeglumine (Magnevist, BAY86-4882)|Participant received a single intravenous injection with Gadopentate (0.5 M) at a volume of 0.4 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.6 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484926|NCT00395733|E1|Reported Event|Gadobutrol (Gadavist, BAY86-4875)|Participant received a single intravenous injection with Gadobutrol (1.0 M) at a volume of 0.2 mL/kg BW (dose = 0.2 mmol/kg BW) or up to 0.3 mL/kg BW when 3 Fields of View were imaged (up to dose = 0.3 mmol/kg BW)
484927|NCT00395694|B3|Baseline|Total|Total of all reporting groups
484928|NCT00395694|B2|Baseline|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484929|NCT00395694|B1|Baseline|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484930|NCT00395694|P2|Participant Flow|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484931|NCT00395694|P1|Participant Flow|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484983|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484984|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
485213|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
484932|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484933|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484934|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484935|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484936|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484937|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484938|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484939|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484985|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484986|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
485214|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
484940|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484941|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484942|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484943|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484944|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484945|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484946|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484947|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484948|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
485215|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
484949|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484950|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484951|NCT00395694|O1|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484952|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484953|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484954|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484955|NCT00395694|O3|Outcome|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484956|NCT00395694|O2|Outcome|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484987|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484988|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484989|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
485216|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
484957|NCT00395694|O1|Outcome|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484958|NCT00395694|E3|Reported Event|Total: LTG|Adult participants were initiated on 12.5 mg/day, and adolescents were initiated on 0.15 mg/kg/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking VPA or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. During the MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484959|NCT00395694|E2|Reported Event|Adolescents: LTG|Adolescent participants were initiated on 0.15 mg/kilogram (kg)/day. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (MP). During the 8-week MP, adolescents taking VPA alone received up to a maximum of 3 mg/kg/day, adolescents taking VPA with an inducer of LTG glucuronidation received up to a maximum of 5 mg/kg/day, and adolescents not taking VPA with an inducer of LTG glucuronidation received up to a maximum of 15 mg/kg/day. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative AEDs were available were allowed to continue treatment with BW430C until the drug is marketed (continuation phase).
484960|NCT00395694|E1|Reported Event|Adults: LTG|Adult participants were initiated on 12.5 milligrams per day (mg/day) of BW430C (lamotrigine [LTG]) (as a tablet taken orally) once daily. Participants had their dose increased to an optimal maintenance dose (escalation phase) and then were maintained at that dose for 8 weeks (maintenance phase [MP]). During the 8-week MP, participants received up to a maximum of 200 mg/day for adults taking valproeic acid (VPA) or up to a maximum of 400 mg/day for adults not taking VPA plus an inducer of LTG glucuronidation. Participants who achieved adequate seizure control at the end of the MP and for whom no alternative antiepileptic drugs (AEDs) were available were allowed to continue treatment with LTG until the drug is marketed (continuation phase).
484961|NCT00396409|B3|Baseline|Total|Total of all reporting groups
484962|NCT00396409|B2|Baseline|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484963|NCT00396409|B1|Baseline|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484964|NCT00396409|P2|Participant Flow|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484965|NCT00396409|P1|Participant Flow|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484966|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484967|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484968|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484969|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484970|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484971|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484972|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484973|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484974|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484975|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484976|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484977|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484978|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484979|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484980|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484981|NCT00396409|O1|Outcome|Depigoid + Omalizumab|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484982|NCT00396409|O2|Outcome|Depigoid + Placebo|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
485217|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
484990|NCT00396409|E4|Reported Event|Depigoid + Placebo 2008|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484991|NCT00396409|E3|Reported Event|Depigoid + Placebo 2007|Depigoid dministered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Placebo was given during the 2006 core study
484992|NCT00396409|E2|Reported Event|Depigoid + Omalizumab 2008|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484993|NCT00396409|E1|Reported Event|Depigoid + Omalizumab 2007|Depigoid administered in 4-week intervals using 0.5 ml of vial 2 (1000 DPP/mL). Omalizumab was given during the 2006 core study.
484994|NCT00396383|B1|Baseline|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
484995|NCT00396383|P1|Participant Flow|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
484996|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
484997|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
484998|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
484999|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
485000|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
485001|NCT00396383|O1|Outcome|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
485002|NCT00396383|E1|Reported Event|Participants With Multiple Myeloma (MM)|Participants with MM who were eligible for autologous peripheral blood stem cell transplantation were given 240 µg/kg daily subcutaneous plerixafor for up to 4 days.
485003|NCT00396331|B5|Baseline|Total|Total of all reporting groups
485004|NCT00396331|B4|Baseline|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485005|NCT00396331|B3|Baseline|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485006|NCT00396331|B2|Baseline|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485007|NCT00396331|B1|Baseline|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485008|NCT00396331|P1|Participant Flow|G-CSF Plus Plerixafor|Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485009|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485010|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485011|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485090|NCT00396266|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485012|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485013|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485014|NCT00396331|O1|Outcome|PK Subpopulation|Participants in the pharmacokinetic (PK) subpopulation that offered blood samples for PK analysis. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485015|NCT00396331|O5|Outcome|All Patients|
485016|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485017|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485018|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485019|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485020|NCT00396331|O5|Outcome|All Patients|
485021|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485022|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485023|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485024|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485025|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485026|NCT00396331|O5|Outcome|All Patients|
485027|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485028|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485029|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485030|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485031|NCT00396331|O5|Outcome|All Patients|
485032|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485033|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485034|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485035|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485036|NCT00396331|O5|Outcome|All Patients|
485037|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485038|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485039|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485040|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485041|NCT00396331|O5|Outcome|All Patients|
485042|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485043|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485044|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485045|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485046|NCT00396331|O5|Outcome|All Patients|
485047|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485048|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485049|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485050|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485051|NCT00396331|O5|Outcome|All Patients|
485052|NCT00396331|O4|Outcome|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485053|NCT00396331|O3|Outcome|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485054|NCT00396331|O2|Outcome|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485055|NCT00396331|O1|Outcome|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485056|NCT00396331|E4|Reported Event|Other Cancers|Participants with 'other' cancers (desmoplastic small round cell tumor, acute myeloid leukemia, and testicular cancer) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485057|NCT00396331|E3|Reported Event|Multiple Myeloma|Participants with multiple myeloma (MM) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485058|NCT00396331|E2|Reported Event|Hodgkin's Disease|Participants with Hodgkin's disease (HD) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485059|NCT00396331|E1|Reported Event|Non-Hodgkin's Lymphoma|Participants with non-Hodgkin's lymphoma (NHL) were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 7 aphereses or until ≥ 2*10^6 CD34+ cells/kg were collected.
485060|NCT00396318|B1|Baseline|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485061|NCT00396318|P1|Participant Flow|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485087|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485205|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485062|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485063|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485064|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485065|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485066|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485067|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485068|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485088|NCT00396279|E1|Reported Event|Denosumab 120 mg Q4W|Participants received a dose loading regimen of 3 subcutaneous injections of denosumab 120 mg every week for 3 weeks (study Days 1, 8, and 15), followed by a week of rest, and then 120 mg denosumab once every 4 weeks (Q4W) from Day 29.
485089|NCT00396266|B3|Baseline|Total|Total of all reporting groups
485206|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485069|NCT00396318|O1|Outcome|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485070|NCT00396318|E1|Reported Event|Tenecteplase|2 mL tenecteplase administered to dwell for 15 (±5) minutes, after which central venous catheter (CVC) function was assessed. Restoration of CVC function was defined as successful withdrawal of at least 3 mL of blood or fluid and infusion of 5 mL of normal saline in patients weighing ≥ 10 kg, and withdrawal of at least 1 mL of blood or fluid and infusion of 3 mL of normal saline in patients weighing < 10 kg. In CVCs for which function was not restored, study drug was left to dwell for an additional 15 (±5) minutes (30 minutes post-treatment), after which CVC function was assessed as before. In CVCs for which function was not restored, study drug was left to dwell for an additional 90 (±10) minutes (120 minutes post-treatment), after which CVC function was assessed as before. If CVC function was not restored by 120 minutes after Dose 1, Dose 2 was given. Assessment of CVC function was repeated as before, after 15 (±5) minutes and, if needed, after 30 (±5) minutes and 120 (±10) minutes.
485071|NCT00396292|B3|Baseline|Total|Total of all reporting groups
485072|NCT00396292|B2|Baseline|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
485073|NCT00396292|B1|Baseline|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
485074|NCT00396292|P2|Participant Flow|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
485075|NCT00396292|P1|Participant Flow|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
485076|NCT00396292|O2|Outcome|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
485077|NCT00396292|O1|Outcome|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
485078|NCT00396292|E2|Reported Event|Oral Iron Tablets|325 mg tablets (65 mg elemental iron) with instructions to take 1 tablet by mouth (PO) TID with 8 ounces of tap water, 1 hour before meals from Day 0 until Day 42
485079|NCT00396292|E1|Reported Event|VIT-45|A maximum of 1,000 mg iron as IV VIT-45 given at weekly intervals until the the cumulative dose has been reached or a maximum of 2,500 mg has been administered
485080|NCT00396279|B1|Baseline|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485081|NCT00396279|P1|Participant Flow|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485082|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485083|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485084|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485085|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485086|NCT00396279|O1|Outcome|Denosumab|Participants received denosumab 120 mg once every 4 weeks (Q4W), with an additional 120 mg dose on Days 8 and 15 of the first month of treatment. All participants were instructed to take daily supplements of at least 500 mg of calcium and 400 IU of vitamin D. Participants were to continue to receive denosumab until one of the following occurred: complete tumor resection, disease progression without clinical benefit, or decision by the participant to discontinue for any reason.
485091|NCT00396266|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485092|NCT00396266|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485093|NCT00396266|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485094|NCT00396266|O1|Outcome|PD Subgroup|Subgroup of 4 patients (3 MM and 1 NHL) for which a pharmacodynamic (PD) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485095|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485096|NCT00396266|O3|Outcome|Total|All patients.
485097|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485098|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485099|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485100|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485101|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485102|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485103|NCT00396266|O1|Outcome|PK Subgroup|Subgroup of 13 participants (5 NHL and 8 MM) for which a pharmacokinetic (PK) profile was analyzed. Participants were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days, followed by plerixafor 240 µg/kg the evening of day 4.
485104|NCT00396266|O1|Outcome|Non-hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485105|NCT00396266|O3|Outcome|Total|All patients.
485106|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485107|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485108|NCT00396266|O3|Outcome|Total|All patients.
485109|NCT00396266|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485110|NCT00396266|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485111|NCT00396266|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485207|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485208|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485112|NCT00396266|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
485113|NCT00396253|B1|Baseline|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485114|NCT00396253|P1|Participant Flow|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485115|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485116|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485117|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485118|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485119|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485120|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485121|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485122|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485123|NCT00396253|O1|Outcome|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485124|NCT00396253|E1|Reported Event|Tenecteplase|At each treatment, patients had 2 mL (2 mg) of tenecteplase instilled into each lumen of their HD catheter. Patients could receive up to three treatments with tenecteplase, the first two as part of the initial treatment course and one additional treatment as part of the retreatment (RT) course. The first treatment, followed by a 1-hour dwell time, was given to all patients at Visit 1. At the end of hemodialysis at Visit 1, eligible patients had a second treatment instilled for an extended dwell time until the start of Visit 2 (up to 72 hours).
485550|NCT00395486|E2|Reported Event|Atorvastatin|10mg
485125|NCT00396201|B1|Baseline|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485126|NCT00396201|P1|Participant Flow|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin's disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with granulocyte-colony stimulating factor (G-CSF) [10 µg/kg each day (QD)] and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485127|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485128|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485129|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485130|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485131|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485132|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485133|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485134|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485135|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485136|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485137|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485138|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485139|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485140|NCT00396201|O1|Outcome|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485209|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485210|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485211|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485141|NCT00396201|E1|Reported Event|Participants With Hodgkin's Disease (HD)|Participants with Hodgkin’s Disease who were eligible for autologous peripheral blood stem cell transplantation. Participants underwent mobilization with G-CSF (10 µg/kg QD) and received plerixafor (240 µg/kg) on each day prior to apheresis. Participants were apheresed for up to 5 consecutive days in order to collect the target number of CD34+ stem cells, (≥5*10^6 cells/kg).
485142|NCT00396162|B3|Baseline|Total|Total of all reporting groups
485143|NCT00396162|B2|Baseline|Placebo Pill|"Placebo pills on same schedule as active intervention.~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
485144|NCT00396162|B1|Baseline|Probiotic|"drug~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
485145|NCT00396162|P2|Participant Flow|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485146|NCT00396162|P1|Participant Flow|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485147|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485148|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485149|NCT00396162|O2|Outcome|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485150|NCT00396162|O1|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485151|NCT00396162|O2|Outcome|Probiotic|"L. rhamnosus R0011 strain~probiotic containing L.rhamnosus R0011 strain: 500 million active cells of L rhamnosus R0011 strain per tablet bid for 4 weeks"
485152|NCT00396162|O1|Outcome|Placebo Pill|"Placebo pills on same schedule as active intervention.~Placebo: Placebo pill"
485153|NCT00396162|O2|Outcome|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485154|NCT00396162|O1|Outcome|Probiotic|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485155|NCT00396162|E2|Reported Event|Placebo|Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485156|NCT00396162|E1|Reported Event|Active Intervention|The study protocol scheduled daily oral supplementation of either the probiotic or the placebo twice daily for four weeks. The probiotic product was a chewable tablet containing 500 million active cells of L rhamnosus R0011 strain per tablet. Placebo tablets comparable to the probiotic in color, weight, texture, and flavor were also available.
485157|NCT00396136|B1|Baseline|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
485158|NCT00396136|P1|Participant Flow|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
485159|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
485160|NCT00396136|O1|Outcome|Corox OTW Unipolar Lead|Study Participants followed for three years post implant.
485161|NCT00396136|E1|Reported Event|Group 1|
485162|NCT00396097|B3|Baseline|Total|Total of all reporting groups
485163|NCT00396097|B2|Baseline|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485164|NCT00396097|B1|Baseline|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485165|NCT00396097|P2|Participant Flow|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485166|NCT00396097|P1|Participant Flow|Standard Dose Arm|The participants received subcutaneous genotropin, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485167|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
485168|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
485169|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
485170|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485171|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24/mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
485172|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
485173|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
485174|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485175|NCT00396097|O4|Outcome|Individualized Dose Arm 0.24 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.24 mg/kg/week for the remaining 2 years.
485176|NCT00396097|O3|Outcome|Individualized Dose Arm 0.18 mg/kg/Week|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses 0.18 mg/kg/week for the remaining 2 years.
485177|NCT00396097|O2|Outcome|Individualized Dose Arm Overall|"The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.~The combined individualized dose group (N=202) includes 179 subjects who, at the start of the maintenance phase, were randomized to either 0.18 or 0.24 mg/kg/week dose subgroup. The remaining 23 subjects were not randomized at the start of the maintenance phase either due to early termination (n=19), or because they were initially randomized to the individualized dose, had the dose calculated to 0 mg, and had received the standard dose for the remainder of the study (n=4)."
485178|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485179|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485180|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485181|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485182|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485183|NCT00396097|O2|Outcome|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485184|NCT00396097|O1|Outcome|Standard Dose Arm|The participants received subcutaneous genotropin daily, at maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485185|NCT00396097|E2|Reported Event|Individualized Dose Arm|The participants received subcutaneous genotropin daily, at formula-calculated dose (up to maximum dose of 0.7 mg/kg/week) for the initial 2 years and then lowered to one of two approximately physiological doses (0.18 mg/kg/week or 0.24 mg/kg/week) for the remaining 2 years.
485186|NCT00396097|E1|Reported Event|Standard Dose Arm|The participants received subcutaneous genotropin daily, at a maintained standard dose of 0.37 mg/kg/week, throughout the four years.
485187|NCT00396084|B7|Baseline|Total|Total of all reporting groups
485188|NCT00396084|B6|Baseline|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485189|NCT00396084|B5|Baseline|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485190|NCT00396084|B4|Baseline|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
485191|NCT00396084|B3|Baseline|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
485192|NCT00396084|B2|Baseline|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485193|NCT00396084|B1|Baseline|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485194|NCT00396084|P6|Participant Flow|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485195|NCT00396084|P5|Participant Flow|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485196|NCT00396084|P4|Participant Flow|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
485197|NCT00396084|P3|Participant Flow|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
485198|NCT00396084|P2|Participant Flow|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485199|NCT00396084|P1|Participant Flow|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485200|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485201|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid 600 mg/day x 7 days
485202|NCT00396084|O1|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485203|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485204|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485551|NCT00395486|E1|Reported Event|Rosuvastatin|10mg
485218|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485219|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485220|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485221|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485222|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485223|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485224|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485225|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485226|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
485227|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485228|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485229|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485230|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485231|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485232|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485233|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485234|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485235|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485236|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485237|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7 days
485238|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485239|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485240|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485241|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485242|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485243|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485244|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485245|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485246|NCT00396084|O3|Outcome|Linezolid 600 mg/Twice Daily|Linezolid 600 mg q12h x 7 days
485247|NCT00396084|O2|Outcome|Linezolid 600 mg/Once Daily|Linezolid, 600 mg/day x 7 days
485248|NCT00396084|O1|Outcome|Isoniazid 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485249|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485250|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485251|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485252|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485253|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485254|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485255|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485256|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485257|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485258|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485259|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485260|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485261|NCT00396084|O4|Outcome|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485262|NCT00396084|O3|Outcome|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485263|NCT00396084|O2|Outcome|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485264|NCT00396084|O1|Outcome|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485265|NCT00396084|E6|Reported Event|Isoniazid (INH) 300 mg/Day|Isoniazid (INH) 300 mg/day x 7 days
485266|NCT00396084|E5|Reported Event|Moxifloxacin 400 mg/Day|Moxifloxacin 400 mg/day x 7 days
485267|NCT00396084|E4|Reported Event|Linezolid 600 mg / Twice Daily|Linezolid 600 mg twice daily x 7 days
485268|NCT00396084|E3|Reported Event|Linezolid 600 mg / Once Daily|Linezolid 600 mg/once daily x 7days
485269|NCT00396084|E2|Reported Event|Levofloxacin 1000 mg/Day|Levofloxacin 1000 mg/day x 7days
485270|NCT00396084|E1|Reported Event|Gatifloxacin 400 mg/Day|Gatifloxacin 400 mg/day x 7 days
485271|NCT00396032|B3|Baseline|Total|Total of all reporting groups
485272|NCT00396032|B2|Baseline|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485273|NCT00396032|B1|Baseline|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485274|NCT00396032|P2|Participant Flow|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485275|NCT00396032|P1|Participant Flow|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485276|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485277|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485278|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485552|NCT00395460|B3|Baseline|Total|Total of all reporting groups
485279|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485280|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485281|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485282|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485283|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485284|NCT00396032|O2|Outcome|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485285|NCT00396032|O1|Outcome|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485286|NCT00396032|E2|Reported Event|Placebo|For the initial treatment, 2 mL of placebo instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485287|NCT00396032|E1|Reported Event|Tenecteplase|For the initial treatment, 2 mL of reconsituted lyophilized tenecteplase instilled into each lumen of the HD catheter; subsequent treatments were 2 mL of open-label tenecteplase
485288|NCT00396006|B1|Baseline|Participants Treated With ARALAST Fr. IV-1|
485289|NCT00396006|P1|Participant Flow|Participants Treated With ARALAST Fraction IV-1 (Fr. IV-1)|Weekly infusions of ARALAST Fr. IV-1 were administered to participants at a dosage of 60 mg/kg
485290|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
485291|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
485292|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485293|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485294|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485295|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485296|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485297|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485298|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485299|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485300|NCT00396006|O1|Outcome|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
485301|NCT00396006|O1|Outcome|Per Protocol|Treated participants with no major protocol violations, evaluable pre- and post-treatment BAL procedures, and 8 consecutive weekly treatments.
485302|NCT00396006|E1|Reported Event|Intent to Treat|Treated participants with relevant assessments, e.g. if pre- and post-treatment BAL procedures were required to assess the parameter, then the participant had both evaluable BAL procedures.
485303|NCT00395993|B3|Baseline|Total|Total of all reporting groups
485304|NCT00395993|B2|Baseline|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
485305|NCT00395993|B1|Baseline|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
485306|NCT00395993|P2|Participant Flow|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
485307|NCT00395993|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
485308|NCT00395993|O2|Outcome|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
485309|NCT00395993|O1|Outcome|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
485310|NCT00395993|E2|Reported Event|Oral Iron Tablets|325 mg tablets TID on Days 0 through Day 42
485311|NCT00395993|E1|Reported Event|Ferric Carboxymaltose (FCM)|Maximum of 1,000 mg of iron as IV FCM given at weekly intervals until the individual's calculated cumulative dose has been reached or a maximum of 2,500 mg has been administered
485312|NCT00395967|B1|Baseline|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485313|NCT00395967|P1|Participant Flow|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485314|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485315|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485316|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485317|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485318|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485319|NCT00395967|O1|Outcome|All Patients|Mobilization with Granulocyte Colony Stimulating Factor (G-CSF) (10 µg/kg once a day) for 5 days. Patients received once daily plerixafor treatment (240 mg/kg) in the evening (10 to 11 hours prior to apheresis) for up to 3 days if peripheral blood CD34+ cell counts on Day 5 met the entry criteria. Morning doses of G-CSF (10 µg/kg) continued throughout apheresis.
485320|NCT00395967|E1|Reported Event|All Patients|All patients (3 NHL, 1 MM, and 1 HD).
485321|NCT00395642|B1|Baseline|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
485322|NCT00395642|P1|Participant Flow|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
485323|NCT00395642|O1|Outcome|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
485324|NCT00395642|E1|Reported Event|Home Monitoring With Weight and BP Remote Monitoring|Device based Home Monitoring with weight and blood pressure (BP) remote monitoring
485325|NCT00395629|B4|Baseline|Total|Total of all reporting groups
485326|NCT00395629|B3|Baseline|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485327|NCT00395629|B2|Baseline|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485328|NCT00395629|B1|Baseline|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485329|NCT00395629|P3|Participant Flow|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485330|NCT00395629|P2|Participant Flow|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485331|NCT00395629|P1|Participant Flow|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485332|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485333|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485334|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485335|NCT00395629|O3|Outcome|Deferasirox (ICL670) 15 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485336|NCT00395629|O2|Outcome|Deferasirox (ICL670) 10 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485337|NCT00395629|O1|Outcome|Deferasirox (ICL670) 5 mg/kg/Day|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485338|NCT00395629|E6|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485339|NCT00395629|E5|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485376|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485340|NCT00395629|E4|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Extension Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485341|NCT00395629|E3|Reported Event|Deferasirox (ICL670) 15 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485342|NCT00395629|E2|Reported Event|Deferasirox (ICL670) 10 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485343|NCT00395629|E1|Reported Event|Deferasirox (ICL670) 5 mg/kg/day_Core Study|Deferasirox (ICL670) was provided as 125 mg, 250 mg, and 500 mg tablets. Dosage was based on the participant's body weight. ICL670 was administered orally, once a day, 30 minutes prior to breakfast.
485344|NCT00395512|B5|Baseline|Total|Total of all reporting groups
485345|NCT00395512|B4|Baseline|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485346|NCT00395512|B3|Baseline|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485347|NCT00395512|B2|Baseline|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485348|NCT00395512|B1|Baseline|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485349|NCT00395512|P4|Participant Flow|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485350|NCT00395512|P3|Participant Flow|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485351|NCT00395512|P2|Participant Flow|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485352|NCT00395512|P1|Participant Flow|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485353|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485354|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485355|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485356|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485357|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485358|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485359|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485360|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485361|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485362|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485363|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485364|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485365|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485366|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485367|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485368|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485369|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485370|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485371|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485372|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485373|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485374|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485375|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485544|NCT00395486|O2|Outcome|Atorvastatin|10mg
485545|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485377|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485378|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485379|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485380|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485381|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485382|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485383|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485384|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485385|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485386|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485387|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485388|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485389|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485390|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485391|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485392|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485393|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485394|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485395|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485396|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485397|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485398|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485399|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485400|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485401|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485402|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485403|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485404|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485405|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485406|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485407|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485408|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485409|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485410|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485411|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485412|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485413|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485414|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485546|NCT00395486|O2|Outcome|Atorvastatin|10mg
485415|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485416|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485417|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485418|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485419|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485420|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485421|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485422|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485423|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485424|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485425|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485426|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485427|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485428|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485429|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485430|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485431|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485432|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485433|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485434|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485435|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485436|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485437|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485438|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485439|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485440|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485441|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485442|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485443|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485444|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485445|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485446|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485447|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485448|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485449|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485450|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485451|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485452|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485547|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485453|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485454|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485455|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485456|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485457|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485458|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485459|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485460|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485461|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485462|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485463|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485464|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485465|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485466|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485467|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485468|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485469|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485470|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485471|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485472|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485473|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485474|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485475|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485476|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485477|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485478|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485479|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485480|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485481|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485482|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485483|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485484|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485485|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485486|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485487|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485488|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485489|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485490|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485548|NCT00395486|O2|Outcome|Atorvastatin|10mg
485491|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485492|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485493|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485494|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485495|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485496|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485497|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485498|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485499|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485500|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485501|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485502|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485503|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485504|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485505|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485506|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485507|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485508|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485509|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485510|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485511|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485512|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485513|NCT00395512|O4|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485514|NCT00395512|O3|Outcome|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485515|NCT00395512|O2|Outcome|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485516|NCT00395512|O1|Outcome|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485517|NCT00395512|E4|Reported Event|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485518|NCT00395512|E3|Reported Event|Alogliptin 25 mg + Pioglitazone 30 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
485519|NCT00395512|E2|Reported Event|Pioglitazone 30 mg|Pioglitazone 30 mg, tablets, orally, once daily and alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
485520|NCT00395512|E1|Reported Event|Alogliptin 25 mg|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
485521|NCT00395486|B3|Baseline|Total|Total of all reporting groups
485522|NCT00395486|B2|Baseline|Atorvastatin|10mg
485523|NCT00395486|B1|Baseline|Rosuvastatin|10mg
485524|NCT00395486|P2|Participant Flow|Atorvastatin|10mg
485525|NCT00395486|P1|Participant Flow|Rosuvastatin|10mg
485526|NCT00395486|O2|Outcome|Atorvastatin|10mg
485527|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485528|NCT00395486|O2|Outcome|Atorvastatin|10mg
485529|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485530|NCT00395486|O2|Outcome|Atorvastatin|10mg
485531|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485532|NCT00395486|O2|Outcome|Atorvastatin|10mg
485533|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485534|NCT00395486|O2|Outcome|Atorvastatin|10mg
485535|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485536|NCT00395486|O2|Outcome|Atorvastatin|10mg
485537|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485538|NCT00395486|O2|Outcome|Atorvastatin|10mg
485539|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485540|NCT00395486|O2|Outcome|Atorvastatin|10mg
485541|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485542|NCT00395486|O2|Outcome|Atorvastatin|10mg
485543|NCT00395486|O1|Outcome|Rosuvastatin|10mg
485553|NCT00395460|B2|Baseline|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485554|NCT00395460|B1|Baseline|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485555|NCT00395460|P2|Participant Flow|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485556|NCT00395460|P1|Participant Flow|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485557|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485558|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485559|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485560|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485561|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485562|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485563|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485564|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485565|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485566|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485567|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485568|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485569|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485570|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485571|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485572|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485573|NCT00395460|O2|Outcome|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485574|NCT00395460|O1|Outcome|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485575|NCT00395460|E2|Reported Event|GD 0.1 mmol/kg BW (Magnevist, BAY86-4882)|Participant received 0.1 mmol/kg BW Gadopentetate Dimeglumine (GD) (= 0.2 mL/kg BW by intravenous injection at a rate of 2.0 mL/sec
485576|NCT00395460|E1|Reported Event|Gadobutrol 0.1 mmol/kg BW (Gadavist, BAY86-4875)|Participant received 0.1 mmol/kg BW Gadobutrol (= 0.1 mL/kg BW by intravenous injection at a rate of 1.0 mL/sec)
485577|NCT00395447|B3|Baseline|Total|Total of all reporting groups
485578|NCT00395447|B2|Baseline|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
485579|NCT00395447|B1|Baseline|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
485580|NCT00395447|P2|Participant Flow|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
485581|NCT00395447|P1|Participant Flow|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
485582|NCT00395447|O2|Outcome|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
485583|NCT00395447|O1|Outcome|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
485584|NCT00395447|E2|Reported Event|Replacement With Planned System Modification|Cohort for patients undergoing device replacement that includes a planned lead addition or revision. The complication rate is defined as the percentage of patients experiencing one or more major complication.
485585|NCT00395447|E1|Reported Event|'Straight-forward' Device Replacement|Cohort for patients undergoing a straight-forward device replacement without any planned system modification
485586|NCT00395343|B3|Baseline|Total|Total of all reporting groups
485658|NCT00395161|B1|Baseline|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
485587|NCT00395343|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485588|NCT00395343|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485589|NCT00395343|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485590|NCT00395343|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485591|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485592|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485593|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485594|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485595|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485596|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485597|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485598|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485599|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485600|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485601|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485602|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485603|NCT00395343|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485604|NCT00395343|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485605|NCT00395343|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with a placebo of the sitagliptin 100 mg oral tablet once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
488855|NCT00386334|O1|Outcome|Placebo|Placebo tablets
485606|NCT00395343|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with insulin (pre-mixed, intermediate-acting, or long-acting) alone or in combination with open-label metformin 500 mg oral tablets (≥1500 mg/day).
485607|NCT00395304|B1|Baseline|All Participants|All participants randomized to the six crossover sequences
485608|NCT00395304|P6|Participant Flow|1xICS + LTRA, 1xICS + LABA, 2xICS|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
485609|NCT00395304|P5|Participant Flow|1xICS + LTRA, 2xICS, 1xICS + LABA|Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
485610|NCT00395304|P4|Participant Flow|1xICS + LABA, 1xICS + LTRA, 2xICS|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline)
485611|NCT00395304|P3|Participant Flow|1xICS +LABA, 2xICS, 1xICS + LTRA|Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
485612|NCT00395304|P2|Participant Flow|2xICS, 1xICS + LTRA, 1xICS + LABA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline)
485613|NCT00395304|P1|Participant Flow|2xICS, 1xICS + LABA, 1xICS + LTRA|Dry-powder inhaler fluticasone 250 mcg bid (Flovent Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone + salmeterol combination 100 mcg/50 mcg bid (Advair Diskus®, GlaxoSmithKline), followed by Dry-powder inhaler fluticasone 100 mcg bid (Flovent Diskus®, GlaxoSmithKline) plus Montelukast 5 or 10 mg qd (Singulair®, Merck)
485614|NCT00395304|O1|Outcome|All Participants|All participants randomized to the six crossover sequences
485615|NCT00395304|E1|Reported Event|All Participants|All participants randomized to the six crossover sequences
485616|NCT00395291|B1|Baseline|Entire Study Population|Includes groups randomized to placebo first and MK-0677 first.
485617|NCT00395291|P2|Participant Flow|Placebo First, Then MK-0677|Subjects took Placebo for at least 30 days.
485618|NCT00395291|P1|Participant Flow|MK-0677 First, Then Placebo|Subjects took 25mg of MK-0677 for at least 30 Days.
485619|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485620|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485621|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485622|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485623|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485624|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485625|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485626|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485627|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485628|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485629|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485630|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485631|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485632|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485633|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485634|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485635|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485636|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485637|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485638|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485639|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485640|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485641|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485642|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485643|NCT00395291|O2|Outcome|Placebo|Subjects took Placebo for at least 30 days.
485644|NCT00395291|O1|Outcome|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485645|NCT00395291|E2|Reported Event|Placebo|Subjects took Placebo for at least 30 days.
485646|NCT00395291|E1|Reported Event|MK-0677|Subjects took 25mg of MK-0677 for at least 30 Days.
485647|NCT00395226|B3|Baseline|Total|Total of all reporting groups
485648|NCT00395226|B2|Baseline|Zinc Sulfate|
485649|NCT00395226|B1|Baseline|Placebo (Lactose)|
485650|NCT00395226|P2|Participant Flow|Zinc Sulfate|
485651|NCT00395226|P1|Participant Flow|Placebo (Lactose)|
485652|NCT00395226|O2|Outcome|Zinc Sulfate|
485653|NCT00395226|O1|Outcome|Placebo (Lactose)|
485654|NCT00395226|E2|Reported Event|Zinc Sulfate|
485655|NCT00395226|E1|Reported Event|Placebo (Lactose)|
485656|NCT00395161|B3|Baseline|Total|Total of all reporting groups
485657|NCT00395161|B2|Baseline|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
485659|NCT00395161|P2|Participant Flow|Enteral Whey Protein, IV Saline|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
485660|NCT00395161|P1|Participant Flow|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
485661|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
485662|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
485663|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
485664|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
485665|NCT00395161|O2|Outcome|Enteral Whey Protein, IV Saline|
485666|NCT00395161|O1|Outcome|Enteral Zinc, Selenium, Glutamine, and IV Metoclopramide|
485667|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
485668|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
485669|NCT00395161|O2|Outcome|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
485670|NCT00395161|O1|Outcome|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
485671|NCT00395161|E2|Reported Event|Whey Protein|Subjects assigned to the whey protein group received 0.3 g/kg beneprotein each morning and intravenous saline every 12 hrs.
485672|NCT00395161|E1|Reported Event|Daily Nutriceutical Supplementation|Subjects assigned to this group received zinc (20 mg), selenium (40 mcg ages 1-3 yrs, 100 mcg age 3-5 yrs, 200 mcg age 5-12 yrs, 400 mcg adolescent), and glutamine (0.3 g/kg) each morning, and intravenous metoclopramide (0.2 mg/kg, maximum 10 mg) every 12 hrs.
485673|NCT00395135|B3|Baseline|Total|Total of all reporting groups
485674|NCT00395135|B2|Baseline|Year 1 - Matching Placebo BID|matching placebo tablets
485675|NCT00395135|B1|Baseline|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
485676|NCT00395135|P5|Participant Flow|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|Patients randomized to placebo in Year 1, completed year 1 and randomized to receive placebo in Year 2.
485677|NCT00395135|P4|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
485678|NCT00395135|P3|Participant Flow|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
485679|NCT00395135|P2|Participant Flow|Year 1 - Matching Placebo BID|matching placebo tablets
485680|NCT00395135|P1|Participant Flow|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
485681|NCT00395135|O3|Outcome|Placebo (Yr 1) / Placebo (Yr 2)|Patients were randomized to placebo in Year 1 and randomized to placebo in Year 2.
485682|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to placebo in Year 2.
485683|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|Patients were randomized to lorcaserin in Year 1, completed year 1 study and randomized to lorcaserin in Year 2.
485684|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
485685|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
485686|NCT00395135|O2|Outcome|Lorcaserin 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 with a Responder status and randomized to placebo in Year 2."
485687|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID (Yr 1) / Lorcaserin 10 mg BID (Yr 2)|"Patients were randomized to lorcaserin in Year 1, completed year 1 study with a Responder status and randomized to lorcaserin in Year 2."
485688|NCT00395135|O2|Outcome|Matching Placebo BID|matching placebo tablets
485689|NCT00395135|O1|Outcome|Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
485690|NCT00395135|E5|Reported Event|Year 2 - Placebo (Yr 1) / Placebo (Yr 2)|matching placebo tablets
485691|NCT00395135|E4|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Matching Placebo (Yr 2)|lorcaserin 10 mg BID tablets, matching placebo tablets
485692|NCT00395135|E3|Reported Event|Year 2 - Lorc 10 mg BID (Yr 1) / Lorc 10 mg BID (Yr 2)|lorcaserin 10 mg BID tablets
485693|NCT00395135|E2|Reported Event|Year 1 - Matching Placebo BID|matching placebo tablets
485694|NCT00395135|E1|Reported Event|Year 1 - Lorcaserin 10 mg BID|lorcaserin 10 mg BID tablets
485695|NCT00395083|B3|Baseline|Total|Total of all reporting groups
485696|NCT00395083|B2|Baseline|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485697|NCT00395083|B1|Baseline|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485698|NCT00395083|P2|Participant Flow|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485699|NCT00395083|P1|Participant Flow|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485700|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485701|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485702|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485703|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485704|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485705|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485706|NCT00395083|O2|Outcome|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485707|NCT00395083|O1|Outcome|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485708|NCT00395083|E2|Reported Event|Comprehensive Care Management Program|"The comprehensive group will receive an initial, intense education program with development of an action plan, and regular telephone contacts by a case manager in addition to standardized COPD care.~COPD Self-management Education: The comprehensive self-management intervention incorporates self-management education, development of an action plan, and case management. The intervention is designed using the social cognitive theory with the Precede-Proceed Model which has guided other successful patient education programs."
485709|NCT00395083|E1|Reported Event|Usual Care|Patients allocated to the control arm will receive standardized care that incorporates guide-line based recommendations including influenza vaccination, a short-acting bronchodilator, and either a long-acting bronchodilator or inhaled corticosteroid inhaler.
485710|NCT00395057|B5|Baseline|Total|Total of all reporting groups
485711|NCT00395057|B4|Baseline|Ranibizumab 500 ug|Ranibizumab 500 ug
485712|NCT00395057|B3|Baseline|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485713|NCT00395057|B2|Baseline|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485714|NCT00395057|B1|Baseline|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485715|NCT00395057|P4|Participant Flow|Ranibizumab 500 ug|Ranibizumab 500 ug
485716|NCT00395057|P3|Participant Flow|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485717|NCT00395057|P2|Participant Flow|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485718|NCT00395057|P1|Participant Flow|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485719|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
485720|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485721|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485722|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485723|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
485724|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485725|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485726|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485727|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
485728|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485729|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485730|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485731|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
485732|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485733|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485734|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485735|NCT00395057|O4|Outcome|Ranibizumab 500 ug|Ranibizumab 500 ug
488856|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
485736|NCT00395057|O3|Outcome|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485737|NCT00395057|O2|Outcome|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485738|NCT00395057|O1|Outcome|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485739|NCT00395057|E4|Reported Event|Ranibizumab 500 ug|Ranibizumab 500 ug
485740|NCT00395057|E3|Reported Event|AGN 211745 Solution 100 ug|AGN 211745 Solution 100 ug
485741|NCT00395057|E2|Reported Event|AGN 211745 Solution 300 ug|AGN 211745 Solution 300 ug
485742|NCT00395057|E1|Reported Event|AGN 211745 Solution 1000 ug|AGN 211745 Solution 1000 ug
485743|NCT00395044|B3|Baseline|Total|Total of all reporting groups
485744|NCT00395044|B2|Baseline|Placebo|1200mg/d of Placebo
485745|NCT00395044|B1|Baseline|Gabapentin|1200 mg/daily of Gabapentin
485746|NCT00395044|P2|Participant Flow|Placebo|Matched Placebo
485747|NCT00395044|P1|Participant Flow|Gabapentin|1200 mg/daily of Gabapentin
485748|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485749|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485750|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485751|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485752|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485753|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485754|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485755|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485756|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485757|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485758|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485759|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485760|NCT00395044|O2|Outcome|Placebo|Matched Placebo
485761|NCT00395044|O1|Outcome|Gabapentin|1200 mg/daily of Gabapentin
485762|NCT00395044|E2|Reported Event|Placebo|1200mg/d of Placebo
485763|NCT00395044|E1|Reported Event|Gabapentin|1200 mg/daily of Gabapentin
485764|NCT00395018|B1|Baseline|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485765|NCT00395018|P1|Participant Flow|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485766|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485767|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485768|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485769|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485770|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485771|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485772|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485773|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485774|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485775|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485776|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485777|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485778|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485779|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485780|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485781|NCT00395018|O1|Outcome|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485782|NCT00395018|E1|Reported Event|Entecavir (ETV)|ETV tablets, Oral, 1.0 mg, once daily, up to 72 weeks
485783|NCT00394953|B3|Baseline|Total|Total of all reporting groups
485784|NCT00394953|B2|Baseline|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485785|NCT00394953|B1|Baseline|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485786|NCT00394953|P2|Participant Flow|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 to Week 52.
485787|NCT00394953|P1|Participant Flow|MIRCERA|Participants with anemia in chronic kidney disease (CKD) who were on hemodialysis received methoxy polyethylene glycol-epoetin beta (MIRCERA [RO0503821]) intravenously (IV) once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 microgram per month (mcg/month) for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485788|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485789|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485790|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485791|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485792|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485793|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485794|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485795|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485796|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485797|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485798|NCT00394953|O2|Outcome|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485799|NCT00394953|O1|Outcome|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485800|NCT00394953|E2|Reported Event|Darbepoetin Alfa|Participants with anemia in CKD who were on hemodialysis received darbepoetin alfa IV once every two weeks up to 26 weeks and received darbepoetin alfa IV twice the dose than earlier, once every month from Week 27 up to Week 52.
485801|NCT00394953|E1|Reported Event|MIRCERA|Participants with anemia in CKD who were on hemodialysis received MIRCERA IV once every month up to 52 weeks. The starting dose of MIRCERA administered during the treatment period was dependent on the dose of darbepoetin alfa administered during screening period and was 120, 200 and 360 mcg/month for weekly darbepoetin alfa doses of <40, 40-80, and >80 mcg, respectively.
485802|NCT00394914|B3|Baseline|Total|Total of all reporting groups
485803|NCT00394914|B2|Baseline|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485804|NCT00394914|B1|Baseline|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485805|NCT00394914|P3|Participant Flow|Placebo|Participants were randomized to receive placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485806|NCT00394914|P2|Participant Flow|Pleconaril|Participants were randomized to receive Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485807|NCT00394914|P1|Participant Flow|All Participants (Pre-randomization)|All participants on study prior to randomization.
485808|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485809|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485810|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485811|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485812|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485813|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485814|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485815|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485816|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485817|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485818|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485819|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
486069|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
485820|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485821|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485822|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485823|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485824|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485825|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485826|NCT00394914|O2|Outcome|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485827|NCT00394914|O1|Outcome|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485828|NCT00394914|E2|Reported Event|Placebo|Participants received placebo nasal spray 4 sprays per nostril BID for 1 week during the Treatment Period for a total of 14 doses.
485829|NCT00394914|E1|Reported Event|Pleconaril|Participants received Pleconaril nasal spray 4 sprays per nostril twice daily (BID), 24 mg/day for 1 week during the Treatment Period for a total of 14 doses.
485830|NCT00394901|B5|Baseline|Total|Total of all reporting groups
485831|NCT00394901|B4|Baseline|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485832|NCT00394901|B3|Baseline|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485833|NCT00394901|B2|Baseline|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485834|NCT00394901|B1|Baseline|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485835|NCT00394901|P4|Participant Flow|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485836|NCT00394901|P3|Participant Flow|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485837|NCT00394901|P2|Participant Flow|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485838|NCT00394901|P1|Participant Flow|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485839|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485840|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485841|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485842|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485843|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485844|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485845|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485846|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485847|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485848|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485849|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485850|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485851|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485852|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485853|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485854|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485855|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485856|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485857|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485858|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485859|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485860|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485861|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485862|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485863|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485864|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485865|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485866|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485867|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485868|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485869|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485870|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485871|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485872|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485873|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485874|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485875|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485876|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485877|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485878|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485879|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485880|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485881|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485882|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485883|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485884|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485885|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485886|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485887|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485888|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485889|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485890|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485891|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485892|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485893|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485894|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485895|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485896|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485897|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485898|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485899|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485900|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
488857|NCT00386334|O1|Outcome|Placebo|Placebo tablets
485901|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485902|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485903|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485904|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485905|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485906|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485907|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485908|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485909|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485910|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485911|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485912|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485913|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485914|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485915|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485916|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485917|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485918|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485919|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485920|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485921|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485922|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485923|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485924|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485925|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485926|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485927|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485928|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485929|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485930|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485931|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485932|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485933|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485934|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485935|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485936|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485937|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485938|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485939|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485940|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485941|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485942|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485943|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485944|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485945|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485946|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485947|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485948|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485949|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485950|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485951|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485952|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485953|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485954|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485955|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485956|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485957|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485958|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485959|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485960|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485961|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485962|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485963|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485964|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485965|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485966|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485967|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485968|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485969|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485970|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485971|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485972|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485973|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485974|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485975|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485976|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485977|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485978|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485979|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485980|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485981|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485982|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485983|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485984|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485985|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485986|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485987|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485988|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485989|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485990|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485991|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485992|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485993|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485994|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485995|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
485996|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
485997|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
485998|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
485999|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486000|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486001|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486002|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486003|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486004|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486005|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486006|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486007|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486008|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486009|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486010|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486011|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486012|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486013|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486014|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486015|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486016|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486017|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486018|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486019|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486020|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486021|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486022|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486023|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486024|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
488858|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
486025|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486026|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486027|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486028|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486029|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486030|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486031|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486032|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486033|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486034|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486035|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486036|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486037|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486038|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486039|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486040|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486041|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486042|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486043|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486044|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486045|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486046|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486047|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486048|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486049|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486050|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486051|NCT00394901|O3|Outcome|Expected Pregabalin Exposure of 600 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 300 mg/day and subjects who received pregabalin 600 mg/day.
486052|NCT00394901|O2|Outcome|Expected Pregabalin Exposure of 300 mg/Day|Subjects with low CLcr (> 30 and <= 60 mL/min) who received pregabalin 150 mg/day and subjects with normal CLcr (> 60 mL/min) who received pregabalin 300 mg/day.
486053|NCT00394901|O1|Outcome|Placebo|Subjects who received matching placebo during a 13-week double-blind treatment phase.
486054|NCT00394901|O4|Outcome|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486055|NCT00394901|O3|Outcome|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486056|NCT00394901|O2|Outcome|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486057|NCT00394901|O1|Outcome|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486058|NCT00394901|E4|Reported Event|Pregabalin 600 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects with low CLcr received pregabalin 300 mg/day and subjects with normal CLcr received pregabalin 600 mg/day for 12 weeks.
486059|NCT00394901|E3|Reported Event|Pregabalin 300 mg/Day|During a 13-week double-blind phase, after 1 week of up titration, subjects received pregabalin 300 mg/day for 12 weeks.
486060|NCT00394901|E2|Reported Event|Pregabalin 150 mg/Day|During a 13-week double-blind phase, subjects received pregabalin 150 mg/day.
486061|NCT00394901|E1|Reported Event|Placebo|During a 13-week double-blind phase, subjects received matching placebo.
486062|NCT00394888|B4|Baseline|Total|Total of all reporting groups
486063|NCT00394888|B3|Baseline|Multiple Hemangiomas|Patients with multiple hemangiomas
486064|NCT00394888|B2|Baseline|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
486065|NCT00394888|B1|Baseline|Facial Hemangioma|Patients with large facial hemangioma.
486066|NCT00394888|P3|Participant Flow|Multiple Hemangiomas|Patients with multiple hemangiomas
486067|NCT00394888|P2|Participant Flow|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
486068|NCT00394888|P1|Participant Flow|Facial Hemangioma|Patients with large facial hemangioma.
486070|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
486071|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
486072|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
486073|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
486074|NCT00394888|O1|Outcome|All Participants|entire population count for MRI/A
486075|NCT00394888|E3|Reported Event|Multiple Hemangiomas|Patients with multiple hemangiomas
486076|NCT00394888|E2|Reported Event|Lumbosacral Hemangioma|Patients with lumbosacral hemangioma.
486077|NCT00394888|E1|Reported Event|Facial Hemangioma|Patients with large facial hemangioma.
486078|NCT00394836|B3|Baseline|Total|Total of all reporting groups
486079|NCT00394836|B2|Baseline|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486080|NCT00394836|B1|Baseline|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486081|NCT00394836|P2|Participant Flow|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
486082|NCT00394836|P1|Participant Flow|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
486083|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486084|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486085|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486086|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486087|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486088|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486089|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486090|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486091|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486092|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486093|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486094|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486095|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486096|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486097|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486098|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486099|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486100|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486101|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486102|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486103|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486104|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486105|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486106|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486107|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486108|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486109|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486110|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486111|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486112|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486113|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486114|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486115|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486116|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486117|NCT00394836|O2|Outcome|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486118|NCT00394836|O1|Outcome|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486119|NCT00394836|E4|Reported Event|Ofatumumab 1000 mg: Extended Follow-up Phase|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new Follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
486120|NCT00394836|E3|Reported Event|Ofatumumab 500 mg: Extended Follow-up Phase|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions. In the extended follow-up phase of the study, participants were followed only for survival status for up to 5 years and new follicular lymphoma (FL) treatment. Time to the next FL treatment analysis included participants which received new FL treatment during extended follow-up.
486121|NCT00394836|E2|Reported Event|Ofatumumab 1000 mg|Ofatumumab iv infusion initiated at 300 mg, followed by an infusion of 1000 mg administered once weekly for 7 infusions
486122|NCT00394836|E1|Reported Event|Ofatumumab 500 mg|Ofatumumab intravenous (iv) infusion initiated at 300 milligrams (mg), followed by an infusion of 500 mg administered once weekly for 7 infusions
486123|NCT00394771|B5|Baseline|Total|Total of all reporting groups
486124|NCT00394771|B4|Baseline|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486125|NCT00394771|B3|Baseline|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486126|NCT00394771|B2|Baseline|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486127|NCT00394771|B1|Baseline|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486128|NCT00394771|P4|Participant Flow|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486129|NCT00394771|P3|Participant Flow|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486130|NCT00394771|P2|Participant Flow|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486131|NCT00394771|P1|Participant Flow|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486132|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486133|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486134|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486135|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486136|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486137|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486138|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486262|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486263|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486139|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486140|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486141|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486142|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486143|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486144|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486145|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486146|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486147|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486148|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486149|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486150|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486151|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486152|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486153|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486154|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486155|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486156|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486157|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486158|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486159|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486160|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486161|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486162|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486163|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486164|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486165|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486264|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486265|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486166|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486167|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486168|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486169|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486170|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486171|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486172|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486173|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486174|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486175|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486176|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486177|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486178|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486179|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486180|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486181|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486182|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486183|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486184|NCT00394771|O4|Outcome|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486185|NCT00394771|O3|Outcome|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486186|NCT00394771|O2|Outcome|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486187|NCT00394771|O1|Outcome|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486188|NCT00394771|E4|Reported Event|Seasonale|84 days of combination active tablets, each containing 30 mcg EE and 150 mcg LNG, followed by 7 days of placebo tablets.
486189|NCT00394771|E3|Reported Event|High Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 42 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486190|NCT00394771|E2|Reported Event|Midrange Dose DR-1031|21 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 42 days combination active tablets (25 mcg EE/ 150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486191|NCT00394771|E1|Reported Event|Low Dose DR-1031|42 days combination active tablets (20 mcg EE /150 mcg LNG) followed by 21 days combination active tablets (25 mcg EE/150 mcg LNG) followed by 21 days combination active tablets (30 mcg EE/ 150 mcg LNG) followed by 7 days of 10 mcg EE tablets.
486192|NCT00394706|B9|Baseline|Total|Total of all reporting groups
486193|NCT00394706|B8|Baseline|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
486194|NCT00394706|B7|Baseline|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
486195|NCT00394706|B6|Baseline|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486196|NCT00394706|B5|Baseline|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486197|NCT00394706|B4|Baseline|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
486198|NCT00394706|B3|Baseline|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486199|NCT00394706|B2|Baseline|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486200|NCT00394706|B1|Baseline|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
486201|NCT00394706|P8|Participant Flow|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
486202|NCT00394706|P7|Participant Flow|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
486203|NCT00394706|P6|Participant Flow|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486204|NCT00394706|P5|Participant Flow|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486205|NCT00394706|P4|Participant Flow|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
486206|NCT00394706|P3|Participant Flow|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486207|NCT00394706|P2|Participant Flow|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486208|NCT00394706|P1|Participant Flow|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
486209|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
486210|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
486211|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
486212|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
486213|NCT00394706|O4|Outcome|Sham ITD|Sham ITD used by EMS providers in the pre-hospital setting.
486214|NCT00394706|O3|Outcome|Active ITD|Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
486215|NCT00394706|O2|Outcome|Analyze Later|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
486216|NCT00394706|O1|Outcome|Analyze Early|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required.
486217|NCT00394706|E8|Reported Event|Not in AEvAL, Sham|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Sham ITD used by EMS providers in the pre-hospital setting.
486218|NCT00394706|E7|Reported Event|Not in AEvAL, ITD Device|Upon the EMS arrival at the scene of a non-traumatic cardiac arrest, local policy determines the length of CPR done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Impedance Threshold Device used by EMS providers in the pre-hospital setting.
486219|NCT00394706|E6|Reported Event|Analyze Later, Not in ITD vs. Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486220|NCT00394706|E5|Reported Event|Analyze Later + Sham|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486221|NCT00394706|E4|Reported Event|Analyze Later + ITD|Analyze later: upon the EMS arrival at the scene of a non-traumatic cardiac arrest, three minutes of CPR is done prior to the assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of Impedance Threshold Device by EMS providers in the pre-hospital setting.
486222|NCT00394706|E3|Reported Event|Analyze Early, Not in ITD vs Sham|Analyze early. Upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Neither an ITD nor sham device used.
486223|NCT00394706|E2|Reported Event|Analyze Early + Sham|Analyze early: upon EMS arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of a sham ITD by EMS providers in the pre-hospital setting.
486224|NCT00394706|E1|Reported Event|Analyze Early + ITD|Analyze early: upon EMS (emergency medical services) arrival at the scene of a non-traumatic cardiac arrest, the EMS providers assess the cardiac rhythm as soon as possible. Approximately thirty seconds of CPR (cardiopulmonary resuscitation) may be done prior to an assessment of the cardiac rhythm to determine whether a defibrillatory shock is required. Use of ITD (Impedance Threshold Device) by EMS providers in the prehospital setting.
486225|NCT00394654|B3|Baseline|Total|Total of all reporting groups
486226|NCT00394654|B2|Baseline|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486227|NCT00394654|B1|Baseline|PLACEBO|
486228|NCT00394654|P2|Participant Flow|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486229|NCT00394654|P1|Participant Flow|PLACEBO|
486230|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486231|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486232|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486233|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486234|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486235|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486236|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486237|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486238|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486239|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486240|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486241|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486242|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486243|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486244|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486245|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486246|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486247|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486248|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486249|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486250|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486251|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486252|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486253|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486254|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486255|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486256|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486257|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486258|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486259|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486260|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486261|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
488859|NCT00386334|O1|Outcome|Placebo|Placebo tablets
486266|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486267|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486268|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486269|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486270|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486271|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486272|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486273|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486274|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486275|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486276|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486277|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486278|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486279|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486280|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486281|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486282|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486283|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486284|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486285|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486286|NCT00394654|O2|Outcome|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486287|NCT00394654|O1|Outcome|PLACEBO|Placebo administered as a single intravenous (IV) infusion
486288|NCT00394654|E2|Reported Event|MEDI528 9 mg/kg|MEDI-528 at a single dose of 9 mg/kg administered as an IV infusion
486289|NCT00394654|E1|Reported Event|PLACEBO|
486290|NCT00394589|B4|Baseline|Total|Total of all reporting groups
486291|NCT00394589|B3|Baseline|Control|Continuation of infliximab 3 mg/kg every 8 weeks
486292|NCT00394589|B2|Baseline|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
486293|NCT00394589|B1|Baseline|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
486294|NCT00394589|P3|Participant Flow|Control|Continuation of infliximab 3 mg/kg every 8 weeks
486295|NCT00394589|P2|Participant Flow|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
486296|NCT00394589|P1|Participant Flow|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
486297|NCT00394589|O3|Outcome|Control|Continuation of infliximab 3 mg/kg every 8 weeks
486298|NCT00394589|O2|Outcome|Increased Frequency|Continuing the same dose of 3 mg/kg infliximab, but at every 6 weeks
486299|NCT00394589|O1|Outcome|Increased Dose|3 mg/kg infliximab + 1 extra vial (100 mg) infliximab every 8 weeks
486300|NCT00394589|E3|Reported Event|Control*Infliximab*3mg/kg Q8W|
486301|NCT00394589|E2|Reported Event|Infliximab*3mg/kg Q6W|
486302|NCT00394589|E1|Reported Event|Infliximab*3mg/kg+1*Vial Q8W|
486303|NCT00394524|B3|Baseline|Total|Total of all reporting groups
486304|NCT00394524|B2|Baseline|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
486305|NCT00394524|B1|Baseline|Glucommander|insulin infusion per Glucommander
486306|NCT00394524|P2|Participant Flow|Standard Insulin Infusion|standard continuous insulin infusion with columnar algorithm; dosage or rate of insulin per algorithm
486307|NCT00394524|P1|Participant Flow|Glucommander|continuous insulin infusion per Glucommander, a computer-guided device; dosage or rate of insulin per algorithm
486308|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
486309|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
486310|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
486311|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
486312|NCT00394524|O2|Outcome|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
486313|NCT00394524|O1|Outcome|Glucommander|insulin infusion per Glucommander
486314|NCT00394524|E2|Reported Event|Standard Insulin Infusion|standard insulin infusion with columnar algorithm
486315|NCT00394524|E1|Reported Event|Glucommander|insulin infusion per Glucommander
486316|NCT00394472|B3|Baseline|Total|Total of all reporting groups
486317|NCT00394472|B2|Baseline|Placebo|Placebo capsules bid
486318|NCT00394472|B1|Baseline|AZD3355|AZD3355 capsules 65 mg bid
486319|NCT00394472|P2|Participant Flow|Placebo|Placebo capsules bid
486320|NCT00394472|P1|Participant Flow|AZD3355|AZD3355 capsules 65 mg bid
486321|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
486322|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
486323|NCT00394472|O2|Outcome|Placebo|Placebo capsules bid
486324|NCT00394472|O1|Outcome|AZD3355|AZD3355 capsules 65 mg bid
486325|NCT00394472|E2|Reported Event|Placebo|Placebo capsules bid
486326|NCT00394472|E1|Reported Event|AZD3355|AZD3355 capsules 65 mg bid
486355|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486356|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486357|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486358|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486359|NCT00394355|E4|Reported Event|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486327|NCT00394433|B1|Baseline|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486328|NCT00394433|P1|Participant Flow|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486329|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486330|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486331|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486332|NCT00394433|O1|Outcome|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486333|NCT00394433|E1|Reported Event|Docetaxel, Cisplatin, Irinotecan and Bevacizumab (TPCA)|Patients received bevacizumab 10 mg/kg IV on day 1 every 3 weeks while on study. Additionally, they received docetaxel 30 mg/m2 IV over 30 minutes, followed by cisplatin 25 mg/m2 IV over 30 minutes, followed by irinotecan 50 mg/m2 IV over 30 minutes on days 1 and 8 of each 3-week cycle until disease progression or unacceptable toxicity. Dose reductions were not permitted for bevacizumab although treatment could be held up to 2 months. If bevacizumab was discontinued, treatment with other agents could continue. When docetaxel, cisplatin, or irinotecan was held on day 1 of a cycle, all agents were held.
486334|NCT00394355|B5|Baseline|Total|Total of all reporting groups
486335|NCT00394355|B4|Baseline|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486336|NCT00394355|B3|Baseline|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486337|NCT00394355|B2|Baseline|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486338|NCT00394355|B1|Baseline|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486339|NCT00394355|P4|Participant Flow|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486340|NCT00394355|P3|Participant Flow|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486341|NCT00394355|P2|Participant Flow|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486342|NCT00394355|P1|Participant Flow|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486343|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486344|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486345|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486346|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486347|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486348|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486349|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486350|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486351|NCT00394355|O4|Outcome|ML 10 mg QD PM|Montelukast (ML) 10 mg QD PM for 1 year
486352|NCT00394355|O3|Outcome|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486353|NCT00394355|O2|Outcome|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486354|NCT00394355|O1|Outcome|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486360|NCT00394355|E3|Reported Event|FP MDI 250 mcg BID|Fluticasone proprionate (FP) metered dose inhaler (MDI) 250 mcg twice daily (BID) for 1 year
486361|NCT00394355|E2|Reported Event|MF DPI 400 mcg QD PM|MF DPI 400 mcg QD PM for 1 year
486362|NCT00394355|E1|Reported Event|MF DPI 200 mcg QD PM|Mometasone furoate (MF) dry powder inhaler (DPI) 200 mcg once daily (QD) in the evening (PM) for 1 year
486363|NCT00394329|B5|Baseline|Total|Total of all reporting groups
486364|NCT00394329|B4|Baseline|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486365|NCT00394329|B3|Baseline|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486366|NCT00394329|B2|Baseline|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486367|NCT00394329|B1|Baseline|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486368|NCT00394329|P4|Participant Flow|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486369|NCT00394329|P3|Participant Flow|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486370|NCT00394329|P2|Participant Flow|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486371|NCT00394329|P1|Participant Flow|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate : Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate : Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486372|NCT00394329|O4|Outcome|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486373|NCT00394329|O3|Outcome|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486374|NCT00394329|O2|Outcome|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486375|NCT00394329|O1|Outcome|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486376|NCT00394329|E4|Reported Event|D: Placebo|"Albuterol sulfate administered via a hydrofluoroalkane (HFA) inhaler (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486377|NCT00394329|E3|Reported Event|C: Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486378|NCT00394329|E2|Reported Event|B: Daily ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed"
486379|NCT00394329|E1|Reported Event|A: Daily ICS + Rescue ICS|"Beclomethasone dipropionate administered via a hydrofluoroalkane (HFA) inhaler (QVAR® 40 mcg Inhalation Aerosol) one puff bid + beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed + albuterol sulfate HFA (ProAir®™ 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) one puff bid~Albuterol sulfate: Albuterol sulfate HFA (ProAir® 90 mcg Inhalation Aerosol) rescue puffs as needed~Beclomethasone dipropionate: Beclomethasone dipropionate HFA (QVAR® 40 mcg Inhalation Aerosol) rescue puffs as needed"
486380|NCT00394277|B5|Baseline|Total|Total of all reporting groups
486381|NCT00394277|B4|Baseline|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486382|NCT00394277|B3|Baseline|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486383|NCT00394277|B2|Baseline|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486384|NCT00394277|B1|Baseline|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486385|NCT00394277|P4|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486386|NCT00394277|P3|Participant Flow|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486387|NCT00394277|P2|Participant Flow|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486388|NCT00394277|P1|Participant Flow|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486389|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486390|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486391|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486392|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486393|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486394|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486395|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486396|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486397|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486398|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486427|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486428|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486399|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486400|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486401|NCT00394277|O4|Outcome|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486402|NCT00394277|O3|Outcome|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486403|NCT00394277|O2|Outcome|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486404|NCT00394277|O1|Outcome|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486405|NCT00394277|E4|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1400/1600 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486406|NCT00394277|E3|Reported Event|PEG-IFN 360/180 µg + Ribavirin 1200 mg|PEG-IFN 360 or 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486407|NCT00394277|E2|Reported Event|PEG-IFN 180 µg + Ribavirin 1400/1600 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Patients with a body weight of 85 kg to <95 kg took 600 mg of ribavirin (3 tablets) in the morning and 800 mg (4 tablets) in the evening, or vice versa; total daily dose was 1400 mg. Patients with a body weight ≥ 95 kg took 800 mg of ribavirin (4 tablets) in the morning and evening; total daily dose was 1600 mg.
486408|NCT00394277|E1|Reported Event|PEG-IFN 180 µg + Ribavirin 1200 mg|PEG-IFN 180 µg administered subcutaneously once weekly in abdomen or thigh. Ribavirin 600 mg administered orally twice daily (total of 1200 mg daily).
486409|NCT00394251|B3|Baseline|Total|Total of all reporting groups
486410|NCT00394251|B2|Baseline|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486411|NCT00394251|B1|Baseline|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486412|NCT00394251|P2|Participant Flow|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486413|NCT00394251|P1|Participant Flow|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486414|NCT00394251|O4|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486415|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
486416|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486417|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
486418|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486419|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486420|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486421|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486422|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486423|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486424|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486425|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486426|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486534|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486429|NCT00394251|O3|Outcome|Taxol Subset|175 mg/m2 Taxol plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
486430|NCT00394251|O2|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486431|NCT00394251|O1|Outcome|ABI-007 Subset|260 mg/m2 ABI-007 (Abraxane) plus Bevacizumab for 4 cycles (weeks 9-16); Bevacizumab (weeks 17-46). Weeks 1-8 are excluded from this subset.
486432|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486433|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486434|NCT00394251|O2|Outcome|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486435|NCT00394251|O1|Outcome|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486436|NCT00394251|E2|Reported Event|AC --> Taxol|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 175 mg/m^2 Taxol plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486437|NCT00394251|E1|Reported Event|AC --> ABI-007|Adriamycin and Cytoxan plus Bevacizumab for four cycles (weeks 1-8); 260 mg/m^2 ABI-007 (Abraxane) plus Bevacizumab for four cycles (weeks 9-16); Bevacizumab (weeks 17-46).
486438|NCT00394212|B3|Baseline|Total|Total of all reporting groups
486439|NCT00394212|B2|Baseline|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486440|NCT00394212|B1|Baseline|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486441|NCT00394212|P2|Participant Flow|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486442|NCT00394212|P1|Participant Flow|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486443|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486444|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486445|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486446|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486447|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486448|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486449|NCT00394212|O2|Outcome|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486450|NCT00394212|O1|Outcome|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486451|NCT00394212|E2|Reported Event|Sham Endoscopy|Sham Endoscopy (suturing not performed)
486452|NCT00394212|E1|Reported Event|EndoCinch Suturing System:Transoral Suturing|Transoral suturing of the dilated gastrojejunostomy
486453|NCT00394095|B3|Baseline|Total|Total of all reporting groups
486454|NCT00394095|B2|Baseline|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
486455|NCT00394095|B1|Baseline|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
486456|NCT00394095|P2|Participant Flow|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
486457|NCT00394095|P1|Participant Flow|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
486458|NCT00394095|O2|Outcome|Comparator Group: Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
486459|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
486460|NCT00394095|O2|Outcome|Placebo Group|Group receiving comparable dosage of placebo over 12 weeks.
486461|NCT00394095|O1|Outcome|Experimental Group: Topiramate Group|Change in Body Weight in kilograms over 12 weeks in the Experimental Topiramate sample (N=16) compared to the Placebo group (N=14).
486462|NCT00394095|E2|Reported Event|Comparator Group: Placebo Group|Placebo Group Receiving oral placebo 300-400mg/day for 12 weeks
486463|NCT00394095|E1|Reported Event|Experimental Group: Topiramate Group|Experimental Group Receiving oral Topiramate, 300-400mg/day for 12 weeks
486464|NCT00394082|B1|Baseline|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486465|NCT00394082|P1|Participant Flow|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486466|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486493|NCT00393939|E1|Reported Event|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
488860|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
486467|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486468|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486469|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486470|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486471|NCT00394082|O1|Outcome|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486472|NCT00394082|E1|Reported Event|ABI-007 Plus Bevacizumab|ABI-007 is administered on days 1, 8 and 15 at 125 mg/m^2 and bevacizumab is administered on day 1 and 15 at 10 mg/kg of each 28 day cycle. Treatment continues until disease progression or intolerable toxicity. If a patient develops intolerable toxicity to only one of the drugs, the other drug may be continued as single agent therapy in the absence of progression, as long as the treating physician feels this is in the best interests of the patient.
486473|NCT00393939|B3|Baseline|Total|Total of all reporting groups
486474|NCT00393939|B2|Baseline|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486475|NCT00393939|B1|Baseline|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486476|NCT00393939|P2|Participant Flow|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486477|NCT00393939|P1|Participant Flow|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486478|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486479|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486480|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486481|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486482|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486483|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486484|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486485|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486486|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486487|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486488|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486489|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486490|NCT00393939|O2|Outcome|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486491|NCT00393939|O1|Outcome|Docetaxel + Sunitinib|Sunitinib 37.5 milligrams (mg) daily by oral capsule for 2 weeks followed by a 1-week off-treatment period (Schedule 2/1) with docetaxel 75 milligrams per square meter (mg/m^2) every 3 weeks, or sunitinib 37.5 mg daily in continuous dosing (in absence of docetaxel), or docetaxel 100 mg/m^2 every 3 weeks (in absence of sunitinib).
486492|NCT00393939|E2|Reported Event|Docetaxel|Docetaxel 100 mg/m^2 every 3 weeks
486494|NCT00393913|B1|Baseline|Sleep Apnea Assessment|All participants were assigned to a single Arm (and received the intervention based on whether they had sleep apnea). Participants with sleep apnea used the CPAP machine for 4 to 6 weeks every night and then returned to the sleep laboratory for assessment of daytime function. Those without sleep apnea will have the initial assessment but then will not receive the intervention.
486495|NCT00393913|P1|Participant Flow|CPAP|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
486496|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
486497|NCT00393913|O1|Outcome|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
486498|NCT00393913|O1|Outcome|Sleep Apnea|All participants with obstructive sleep apnea (and no other sleep disorder) and subjects without sleep apnea.
486499|NCT00393913|E1|Reported Event|Continuous Positive Pressure Treatment|All participants with sleep apnea will use a CPAP machine for treatment of sleep apnea.
486500|NCT00393887|B3|Baseline|Total|Total of all reporting groups
486501|NCT00393887|B2|Baseline|Polypropylene Mesh|Synthetic polypropylene mesh
486502|NCT00393887|B1|Baseline|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
486503|NCT00393887|P2|Participant Flow|Polypropylene Mesh|Synthetic polypropylene mesh
486504|NCT00393887|P1|Participant Flow|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
486505|NCT00393887|O2|Outcome|Polypropylene Mesh|Inguinal hernia repair with Polypropylene mesh
486506|NCT00393887|O1|Outcome|Biodesign IHM Graft|Inguinal hernia repair with Biodesign Inguinal Hernia Matrix (IHM)
486507|NCT00393887|E2|Reported Event|Polypropylene Mesh|Synthetic polypropylene mesh
486508|NCT00393887|E1|Reported Event|Biodesign IHM Graft|Biodesign Inguinal Hernia Matrix (IHM)
486509|NCT00393874|B4|Baseline|Total|Total of all reporting groups
486510|NCT00393874|B3|Baseline|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
486511|NCT00393874|B2|Baseline|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
486512|NCT00393874|B1|Baseline|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
486513|NCT00393874|P3|Participant Flow|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
486514|NCT00393874|P2|Participant Flow|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
486531|NCT00393861|B1|Baseline|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486532|NCT00393861|P1|Participant Flow|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486533|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486574|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486515|NCT00393874|P1|Participant Flow|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
486516|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medicat"
486517|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
486518|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin is 10 mg. Some individuals may require doses up to 15 mg, (Murray Raskind, M.D., personal"
486519|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
486520|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
486521|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
486522|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
488861|NCT00386334|O1|Outcome|Placebo|Placebo tablets
486523|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
486524|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
486525|NCT00393874|O3|Outcome|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. They will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. We will monitor subjects carefully and on a weekly basis.~Participants randomized to PLA will take 4 capsules each night for eight weeks, all capsules will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed."
486526|NCT00393874|O2|Outcome|Behavioral|"Participants randomized to BSI will receive the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment will be administered over 8 weeks. The intervention sessions will consist of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session will be conducted on Week 5. Thirty-minute face-to-face contacts will be scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that may have occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction."
486527|NCT00393874|O1|Outcome|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose.~Participants randomized to PRZ will take 4 capsules each night (PRZ dose complemented with placebo capsules ). Prazosin will be administered in an initial oral dose of 1 mg (Week 1), with titration to a maximum of 15 mg. The first increment will be of 1 mg (Week 2: 2 mg), and subsequent weekly increments according to the following schedule: Week 3: 4 mg; Week 4: 6 mg; Week 5: 10 mg; Week 6: 15 mg; Week 7: 15 mg; Week 8: 15 mg. A maximum dose of 15 mg may be necessary."
486528|NCT00393874|E3|Reported Event|Placebo|"Participants randomized to PLA will take 4 capsules each night, and capsule will be identical to prazosin capsules. As for participants randomly assigned to PRZ, they will receive a one-week medication supplies in daily dose dispensers. Similarly, participants will also be instructed to be ready for bed at the time they take the medication, and not to engage in any activities that will prevent them from going to bed. A placebo pill condition is included for several reasons. First, there is no approved treatment approach currently recognized as being effective for sleep disturbances associated with combat-related PTSD, and which is being withheld from subjects assigned to the placebo arm of the study. We will monitor subjects carefully and on a weekly basis.~Placebo: Participants randomized to PLA took 4 capsules each night for eight weeks, all capsules were identical to prazosin capsules. They received a one-week medication."
486529|NCT00393874|E2|Reported Event|Behavioral|"Participants randomized to BSI received the intervention aimed at reducing nightmares, insomnia, and sleep avoidance behavior. The treatment was administered over 8 weeks. The intervention sessions consisted of two individual, 45-minute treatment sessions, delivered on Weeks 1 and 3. A 45-minute booster session was conducted on Week 5. Thirty-minute face-to-face contacts were scheduled on other weeks (i.e., Weeks 2, 4, 6, 7 and 8) to address any difficulty with the treatment instructions and techniques, to answer questions that had occurred, and to complete weekly clinical ratings (CGI-I/SR and ASES).~Behavioral Sleep Intervention: Participants will receive a workbook with information related to the intervention. The three core components are presented and discussed during these sessions are:1) education about sleep and nightmares; 2) imagery rehearsal; 3) stimulus control and sleep restriction. Session 1 focuses on education on PDSD-related insomnia, ni"
486530|NCT00393874|E1|Reported Event|Medication|"Treatment will be conducted under double blind conditions and will last a total of 8 weeks. Participants will also receive printed educational material about sleep hygiene developed by the American Academy of Sleep Medicine. Items include going to bed when drowsy, avoiding clock watching while awake in bed, avoidance of caffeine and alcohol, engaging in moderate exercise, and ensuring comfortable sleep environment. Clinical ratings will be obtained weekly throughout the trial.Medications will be administered in a single dose to be taken 30 minutes prior to bedtime because the onset of action occurs within 30 to 90 minutes after a single dose. The research pharmacy will prepare each dose in identical gelatin capsules to prevent identification.~Prazosin: Participants randomized to PRZ took 4 capsules each night (PRZ dose complemented with placebo capsules ). The target dose of prazosin was 10 mg. Some individuals required doses up to 15 mg."
486575|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486535|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486536|NCT00393861|O1|Outcome|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486537|NCT00393861|E1|Reported Event|Oxaliplatin & Bevacizumab|Bevacizumab and Oxaliplatin: Oxaliplatin 85 mg/M2 IV over 2 hours plus Bevacizumab 10 mg/kg IV over 90 minutes
486538|NCT00393848|B5|Baseline|Total|Total of all reporting groups
486539|NCT00393848|B4|Baseline|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
486540|NCT00393848|B3|Baseline|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
486541|NCT00393848|B2|Baseline|Experiment 1 - Standard of Care|Usual clinical care - no dietary intervention.
486542|NCT00393848|B1|Baseline|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
486543|NCT00393848|P4|Participant Flow|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
486544|NCT00393848|P3|Participant Flow|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
486545|NCT00393848|P2|Participant Flow|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
486546|NCT00393848|P1|Participant Flow|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
486547|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
486548|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
486549|NCT00393848|O4|Outcome|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
486550|NCT00393848|O3|Outcome|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
486551|NCT00393848|O2|Outcome|Experiment 1 - Standard of Care|Usual clinical care without dietary intervention
486552|NCT00393848|O1|Outcome|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement : 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
486553|NCT00393848|E4|Reported Event|Experiment 2 - Placebo|Placebo for Ketoconazole twice daily; started night before surgery and continued through hospitalization.
486554|NCT00393848|E3|Reported Event|Experiment 2 - Ketoconazole|200mg ketoconazole twice daily; started night before surgery and continued through hospitalization.
486555|NCT00393848|E2|Reported Event|Experiment 1 - Standard of Care|Usual clinical care with no dietary intervention.
486556|NCT00393848|E1|Reported Event|Experiment 1 - Amino Acid Supplement|Essential amino acid supplement: 15g of essential amino acid in capsule form three times daily during hospitalization, continued through 6 weeks after discharge.
486557|NCT00393796|B3|Baseline|Total|Total of all reporting groups
486558|NCT00393796|B2|Baseline|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486559|NCT00393796|B1|Baseline|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486560|NCT00393796|P2|Participant Flow|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486561|NCT00393796|P1|Participant Flow|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486562|NCT00393796|O2|Outcome|Placebo|Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486563|NCT00393796|O1|Outcome|SUTENT|Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.
486564|NCT00393796|E2|Reported Event|Placebo Only|"Study participants randomized to receive placebo will receive 50 mg/day PO (capsules) of an inactive substance to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~28 participants were randomized to Placebo. 16 of these 28 patients later received SUTENT."
486565|NCT00393796|E1|Reported Event|SUTENT|"Study participants randomized to received SUTENT will receive a dose of 50 mg PO (capsules) as a single agent to be taken once daily for four consecutive weeks followed by a two week rest period to form a complete cycle of six weeks.~26 participants were randomized to SUTENT and 16 participants randomized to Placebo crossed over to SUTENT during treatment so a total of 42 participants were treated with SUTENT."
486566|NCT00393718|B3|Baseline|Total|Total of all reporting groups
486567|NCT00393718|B2|Baseline|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486568|NCT00393718|B1|Baseline|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486569|NCT00393718|P2|Participant Flow|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486570|NCT00393718|P1|Participant Flow|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486571|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486572|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486573|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486576|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486577|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486578|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486579|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486580|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486581|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486582|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486583|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486584|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486585|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486586|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486587|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486588|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486589|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486590|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486591|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486592|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486593|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486594|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486595|NCT00393718|O2|Outcome|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486596|NCT00393718|O1|Outcome|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486597|NCT00393718|E2|Reported Event|Glibenclamide|Glibenclamide 1.25–2.5 mg + liraglutide placebo
486598|NCT00393718|E1|Reported Event|Liraglutide|Liraglutide 0.9 mg + glibenclamide placebo
486599|NCT00393705|B3|Baseline|Total|Total of all reporting groups
486600|NCT00393705|B2|Baseline|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486601|NCT00393705|B1|Baseline|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486602|NCT00393705|P2|Participant Flow|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486603|NCT00393705|P1|Participant Flow|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486604|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486605|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486606|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486607|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486608|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486609|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486627|NCT00393523|B5|Baseline|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
488862|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
486610|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486611|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486612|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486613|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486614|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486615|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486616|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486617|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486618|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486619|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486620|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486621|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486622|NCT00393705|O2|Outcome|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486623|NCT00393705|O1|Outcome|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486624|NCT00393705|E2|Reported Event|Insulin Biphasic Aspart 30/70 or Insulin Lispro LM|"Twice daily treatment of either biphasic insulin aspart 30/70 or insulin lispro LM (continuation of analogue formulation used before study enrollment).~Insulin Biphasic Aspart 30/70: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks.~Insulin Lispro LM: Participant adjusted dose, twice daily, injected subcutaneously for 16 weeks."
486625|NCT00393705|E1|Reported Event|Insulin Lispro LM + Insulin Lispro MM|"Three times per day insulin lispro mid mixture (MM) with the possiblity to change the evening injection of MM to insulin lispro low mixture (LM) if fasting blood glucose target is not achieved.~Insulin lispro mid mixture (MM): Participant adjusted dose, three times per day, injected subcutaneously for 16 weeks.~Insulin lispro low mixture (LM): Participant adjusted dose, possibly in the evening."
486626|NCT00393523|B6|Baseline|Total|Total of all reporting groups
486734|NCT00393367|P1|Participant Flow|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
486628|NCT00393523|B4|Baseline|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486629|NCT00393523|B3|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486630|NCT00393523|B2|Baseline|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486631|NCT00393523|B1|Baseline|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486632|NCT00393523|P5|Participant Flow|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
486633|NCT00393523|P4|Participant Flow|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486634|NCT00393523|P3|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486635|NCT00393523|P2|Participant Flow|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486636|NCT00393523|P1|Participant Flow|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486637|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486638|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486639|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486640|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486641|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486642|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486643|NCT00393523|O2|Outcome|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486644|NCT00393523|O1|Outcome|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486645|NCT00393523|E5|Reported Event|Modified Process Hepatitis B Vaccine (Group 5)|Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
486646|NCT00393523|E4|Reported Event|ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486647|NCT00393523|E3|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 3)|Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486735|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
488863|NCT00386334|O1|Outcome|Placebo|Placebo tablets
486648|NCT00393523|E2|Reported Event|ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
486649|NCT00393523|E1|Reported Event|Modified Process Hepatitis B Vaccine Booster (Group 1)|Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
486650|NCT00393510|B3|Baseline|Total|Total of all reporting groups
486651|NCT00393510|B2|Baseline|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486652|NCT00393510|B1|Baseline|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486653|NCT00393510|P2|Participant Flow|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486654|NCT00393510|P1|Participant Flow|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486655|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486656|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486657|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486658|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486659|NCT00393510|O2|Outcome|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486660|NCT00393510|O1|Outcome|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486661|NCT00393510|E2|Reported Event|Placebo|Placebo was made with starch and colouring materials. Given to patient orally twice a day
486662|NCT00393510|E1|Reported Event|Traditional Chinese Medicine|12 herbals formulation was given as an adjuvant therapy for the patients orally twice a day.
486663|NCT00393484|B3|Baseline|Total|Total of all reporting groups
486664|NCT00393484|B2|Baseline|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486665|NCT00393484|B1|Baseline|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486666|NCT00393484|P2|Participant Flow|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486667|NCT00393484|P1|Participant Flow|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486668|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486669|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486670|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486671|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486672|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486673|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486674|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486675|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486676|NCT00393484|O2|Outcome|Lamivudine, 100 mg|Participants received lamivudine, 100 mg, once daily for up to 240 weeks
486677|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486914|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
486678|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486679|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486680|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486681|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486682|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486683|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486684|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486685|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486686|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486687|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486688|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486689|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486690|NCT00393484|O2|Outcome|Lamivudine, 100 mg+ Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486691|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486692|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486693|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486694|NCT00393484|O2|Outcome|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486695|NCT00393484|O1|Outcome|Entecavir, 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486696|NCT00393484|E2|Reported Event|Lamivudine, 100 mg + Placebo|Participants received lamivudine, 100 mg, once daily, with entecavir placebo tablets, once daily, administered orally, through Week 96 (double-blind period). Then, participants received lamivudine, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486697|NCT00393484|E1|Reported Event|Entecavir , 0.5 mg + Placebo|Participants received entecavir, 0.5 mg, once daily, with lamivudine placebo tablets, once daily, administered orally through Week 96 (double-blind period). Then, participants received entecavir, 0.5 mg, once daiy, administered orally for Weeks 96-240 (open-label period).
486698|NCT00393458|B5|Baseline|Total|Total of all reporting groups
486699|NCT00393458|B4|Baseline|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486700|NCT00393458|B3|Baseline|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486701|NCT00393458|B2|Baseline|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486702|NCT00393458|B1|Baseline|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486703|NCT00393458|P4|Participant Flow|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486704|NCT00393458|P3|Participant Flow|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486705|NCT00393458|P2|Participant Flow|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486706|NCT00393458|P1|Participant Flow|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486707|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486708|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486709|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486710|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486915|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
486711|NCT00393458|O4|Outcome|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486712|NCT00393458|O3|Outcome|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486713|NCT00393458|O2|Outcome|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486714|NCT00393458|O1|Outcome|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486715|NCT00393458|E4|Reported Event|Placebo to Indacaterol Plus Placebo to Formoterol|Patients inhaled placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Placebo to indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486716|NCT00393458|E3|Reported Event|Formoterol 12 μg Plus Placebo to Indacaterol|Patients inhaled formoterol 12 μg twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®) plus placebo to indacaterol once daily via a single-dose dry-powder inhaler (SDDPI). Formoterol and placebo to indacaterol were taken in the morning between 8:00 and 10:00 AM; formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486717|NCT00393458|E2|Reported Event|Indacaterol 600 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 600 μg (two 300 μg capsules) once daily via single-dose dry-powder inhalers (SDDPI) plus placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486718|NCT00393458|E1|Reported Event|Indacaterol 300 μg Plus Placebo to Formoterol|Patients inhaled indacaterol 300 μg once daily via a single-dose dry-powder inhaler (SDDPI), placebo to indacaterol once daily via a SDDPI, and placebo to formoterol twice daily via the manufacturer’s proprietary inhalation device (Aerolizer®). Indacaterol, placebo to indacaterol, and placebo to formoterol were taken in the morning between 8:00 and 10:00 AM; placebo to formoterol was taken again 12 hours later in the evening between 8:00 and 10:00 PM. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
486719|NCT00393380|B1|Baseline|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486720|NCT00393380|P1|Participant Flow|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486721|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486722|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486723|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486724|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486725|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486726|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486727|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486728|NCT00393380|O1|Outcome|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486729|NCT00393380|E1|Reported Event|Parathyroid Hormone (Teriparatide)|Parathyroid hormone after double umbilical cord blood transplant.
486730|NCT00393367|B3|Baseline|Total|Total of all reporting groups
486731|NCT00393367|B2|Baseline|Placebo (Saline)|standardized treatment with nebulized saline
486732|NCT00393367|B1|Baseline|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
486733|NCT00393367|P2|Participant Flow|Placebo (Saline)|standardized treatment with nebulized saline
488864|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
486736|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
486737|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486738|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486739|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486740|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486741|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486742|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486743|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486744|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486745|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486746|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486747|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486748|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486749|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486750|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486751|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486752|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486753|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486754|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486755|NCT00393367|O2|Outcome|Placebo (Saline)|standardized treatment with nebulized saline
486756|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
486757|NCT00393367|O2|Outcome|Placebo (Normal Saline)|
486758|NCT00393367|O1|Outcome|Budesonide Inhalation Suspension (BIS)|
486759|NCT00393367|E2|Reported Event|Placebo (Saline)|standardized treatment with nebulized saline
486760|NCT00393367|E1|Reported Event|Budesonide Inhalation Suspension (BIS)|standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
486761|NCT00393094|B1|Baseline|Enrollment Until Prior to Treatment|
486762|NCT00393094|P1|Participant Flow|Enrollment Until Prior to Treatment|
486763|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Glioblastoma Multiforme: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Glioblastoma multiforme- is a fast growing type of central nervous system tumor that forms from glial (supportive) tissue of the brain and spinal cord and has cells that look very different from normal cells. Glioblastoma multiforme usually occurs in adults and affects the brain more often than the spinal cord. Also called GBM, glioblastoma, and grade IV astrocytoma.
486764|NCT00393094|O1|Outcome|Bevacizumab & Irinotecan Anaplastic Glioma Pts: Enrollment|Bevacizumab - 10 mg/kg intravenous injection Irinotecan - 125 mg/m^2 if patient is on a non-enzyme inducing anti-epileptic drugs 340 mg/m^2 if patient is on enzyme inducing anti-epileptic drugs every two weeks on a 4 week cycle Anaplastic gliomas are classified by the World Health Organization (WHO) as grade 3 malignant tumors and include the anaplastic astrocytoma, anaplastic oligodendroglioma, and anaplastic oligoastrocytoma or mixed glioma.
486765|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
486766|NCT00393094|O1|Outcome|Enrollment Until Prior to Treatment|
486767|NCT00393094|E1|Reported Event|Enrollment Until Prior to Treatment|
486768|NCT00393068|B1|Baseline|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
486769|NCT00393068|P1|Participant Flow|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
486770|NCT00393068|O1|Outcome|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
486771|NCT00393068|E1|Reported Event|Treatment|"Prior to surgery study treatment will be given over a 6 weeks (Days 1-42) period. Beginning Day 1 and continuing through Day 35 patients will receive a continuous infusion of 5-FU by vein. A small portable pump will be used to administer this drug into a tube that has been surgically inserted into the patient's vein. On Day 1 and 22 patients will also receive the drugs paclitaxel, carboplatin and bevacizumab by vein. Erlotinib is given by mouth beginning on Day 1 and continuing through Day 45. Patients will receive radiation therapy daily, Monday through Friday, beginning Day 1-35 (approximately 5 weeks).~Surgery will be performed approximately 12-14 weeks after beginning this combined treatment."
486772|NCT00393029|B3|Baseline|Total|Total of all reporting groups
486773|NCT00393029|B2|Baseline|Other Metastatic Cancers|
486774|NCT00393029|B1|Baseline|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
486775|NCT00393029|P2|Participant Flow|Other Metastatic Cancers|
486916|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
486776|NCT00393029|P1|Participant Flow|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
486777|NCT00393029|O2|Outcome|Other Metastatic Cancers|
486778|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
486779|NCT00393029|O2|Outcome|Other Metastatic Cancers|
486780|NCT00393029|O1|Outcome|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
486781|NCT00393029|O1|Outcome|Metastatic Melanoma & Other Metastatic Cancers|"Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).~There are no statistical differences between the arms, therefore, they can be combined for this outcome measure."
486782|NCT00393029|E2|Reported Event|Other Metastatic Cancers|
486783|NCT00393029|E1|Reported Event|Metastatic Melanoma|Melanoma is a serious form of skin cancer that develops in the skin cells that make our skin color (melanocytes).
486784|NCT00392925|B5|Baseline|Total|Total of all reporting groups
486785|NCT00392925|B4|Baseline|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
486786|NCT00392925|B3|Baseline|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486787|NCT00392925|B2|Baseline|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486788|NCT00392925|B1|Baseline|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486789|NCT00392925|P4|Participant Flow|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486790|NCT00392925|P3|Participant Flow|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486791|NCT00392925|P2|Participant Flow|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 milligram (mg) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486792|NCT00392925|P1|Participant Flow|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
486793|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486794|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486795|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486796|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486797|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486798|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486799|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
486800|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486801|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486802|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486803|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
486804|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486805|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486806|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486807|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
486808|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486809|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486810|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486811|NCT00392925|O4|Outcome|Non-Randomized From 4 Week Lead-In|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide acetate 180 mcg twice per week (BID) for 2 weeks followed by pramlintide acetate 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not randomized into one of the 3 treatment groups and withdrew from the study.
486812|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486813|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486814|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486815|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486816|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486817|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486818|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486819|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486820|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486917|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
486821|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486822|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486823|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486824|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486825|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486826|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486827|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486828|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486829|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486830|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486831|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486832|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486833|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486834|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486835|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486836|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486837|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486838|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486839|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486840|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486841|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486842|NCT00392925|O3|Outcome|Pramlintide Acetate+ Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486843|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486844|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
487137|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
486845|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486846|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486847|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486848|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486849|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486850|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486851|NCT00392925|O1|Outcome|Lead-In Participants Randomized to Treatment on Day 1|During the 4-week lead-in period, all participants self administered subcutaneous (SC) injections of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to a treatment group.
486852|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486853|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486854|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486855|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486856|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486857|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486858|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486859|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486860|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486861|NCT00392925|O3|Outcome|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486862|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486863|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486864|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486865|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486866|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486867|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486918|NCT00392808|E4|Reported Event|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
486868|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486869|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486870|NCT00392925|O3|Outcome|Pramlintide Acetate + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486871|NCT00392925|O2|Outcome|Pramlintide Acetate|Participants self administered subcutaneous (SC) injections of Pramlintide Acetate 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486872|NCT00392925|O1|Outcome|Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486873|NCT00392925|E4|Reported Event|Participants Not Randomized to Group After Lead-In Period|During the 4-week lead-in period, all participants self administered a subcutaneous injection of pramlintide 180 mcg twice per week (BID) for 2 weeks followed by pramlintide 360 mcg BID for 2 weeks while following a diet aimed at creating a 40% caloric deficit relative to their estimated weight-maintenance energy needs. Participants who lost between 2% and 8% of their enrollment body weight during the lead-in period were randomized at Visit 4 (baseline/Day 1) to 1 of 3 treatment groups (metreleptin, pramlintide, or pramlintide+metreleptin). 38 participants were not Randomized into one of the 3 treatment groups and withdrew from the study.
486874|NCT00392925|E3|Reported Event|Pramlintide + Metreleptin|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486875|NCT00392925|E2|Reported Event|Pramlintide + Placebo|Participants self administered subcutaneous (SC) injections of Pramlintide 360 mcg BID plus Placebo matched to Metreleptin (Placebo-M) BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486876|NCT00392925|E1|Reported Event|Placebo + Metreleptin|Participants self administered subcutaneous (SC) injections of Placebo matched to pramlintide (Placebo-P) BID plus Metreleptin 5 mg BID. Dosing for up to 20 weeks. Participants were asked to maintain a 20% caloric deficit during the treatment period.
486877|NCT00392860|B3|Baseline|Total|Total of all reporting groups
486878|NCT00392860|B2|Baseline|Control Group|Participants will be given a new standard handrim.
486879|NCT00392860|B1|Baseline|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
486880|NCT00392860|P3|Participant Flow|Handrim Control Group|Participants will be given a new standard handrim.
486881|NCT00392860|P2|Participant Flow|PalmRim Experiment|"Participants will have a PalmRim handrim installed on their wheelchair. The PalmRim was designed for individuals who have limited hand function, making it difficult to grasp standard handrims.~Participants were to use the PalmRim handrim for a four month trial period, before returning for follow up evaluations."
486882|NCT00392860|P1|Participant Flow|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair. The Natural-Fit device was designed to directly address the shortcomings of standard handrims and to improve the standard round-tube handrims which were designed over 50 years ago.~Participants used the Natural-Fit Handrim for a four month trial period, before returning for follow up evaluations.~Natural-Fit : Ergonomic handrim for wheelchairs"
486883|NCT00392860|O2|Outcome|Handrim Control Group|Participants will be given a new standard handrim.
486884|NCT00392860|O1|Outcome|Natural-Fit Experiment|"Participants will have a Natural-Fit handrim installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
486885|NCT00392860|E2|Reported Event|Control Group|Participants will be given a new standard handrim.
486886|NCT00392860|E1|Reported Event|Natural-Fit Experiment|"Participants will have a Natural-Fit installed on their wheelchair.~Natural-Fit : Ergonomic handrim for wheelchairs"
486887|NCT00392834|B3|Baseline|Total|Total of all reporting groups
486888|NCT00392834|B2|Baseline|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
486889|NCT00392834|B1|Baseline|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
486919|NCT00392808|E3|Reported Event|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
486920|NCT00392808|E2|Reported Event|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
486921|NCT00392808|E1|Reported Event|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
487138|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
486890|NCT00392834|P2|Participant Flow|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
486891|NCT00392834|P1|Participant Flow|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
486892|NCT00392834|O2|Outcome|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
486893|NCT00392834|O1|Outcome|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
486894|NCT00392834|E2|Reported Event|Regimen B (Rituximab and IVAC Chemotherapy)|Patients receive rituximab IV on day 1, ifosfamide IV continuously and etoposide IV continuously over 24 hours on days 1-5, and high-dose cytarabine IV over 1-3 hours twice daily on days 1-2. Patients receive CNS prophylaxis comprising methotrexate IT and hydrocortisone IT on day 5. Patients also receive pegfilgrastim SC once 24-48 hours after completion of chemotherapy OR G-CSF SC beginning on day 6 and continuing until blood counts recover. Patients with CNS involvement (leptomeningeal and/or intraparenchymal) at diagnosis do not receive CNS prophylaxis as above. Instead, these patients receive a combination of sequential liposomal cytarabine and methotrexate IT or via an Ommaya reservoir on day 1 and then every 14 days as tolerated until completion of systemic chemotherapy.
486895|NCT00392834|E1|Reported Event|Regimen A (R-CODOX-M Chemotherapy)|Patients receive rituximab IV and doxorubicin hydrochloride IV over 15 minutes on day 1, cyclophosphamide IV over 30-60 minutes on days 1 and 2, pegfilgrastim SC on day 3, vincristine IV on days 1 and 8, high-dose methotrexate IV over 2-4 hours on day 15, and leucovorin calcium IV beginning 24 hours after the start of methotrexate and continuing every 6 hours until level is adequate. Patients receive CNS prophylaxis of methotrexate IT, cytarabine IT, and hydrocortisone IT on day 1. Patients with high-risk disease receive an additional dose of cytarabine IT on day 3. Patients also receive G-CSF SC once daily on days 3-9. Once the methotrexate levels drops below 50 nmol/L, patients resume G-CSF SC once daily beginning on approximately day 18 and continuing until blood counts recover.
486896|NCT00392821|B1|Baseline|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
486897|NCT00392821|P1|Participant Flow|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
486898|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
486899|NCT00392821|O1|Outcome|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
486900|NCT00392821|E1|Reported Event|RAD001 and Sorafenib|"RAD001 and Sorafenib~Sorafenib: Sorafenib~RAD001: RAD001"
486901|NCT00392808|B5|Baseline|Total|Total of all reporting groups
486902|NCT00392808|B4|Baseline|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
486903|NCT00392808|B3|Baseline|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
486904|NCT00392808|B2|Baseline|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
486905|NCT00392808|B1|Baseline|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
486906|NCT00392808|P4|Participant Flow|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
486907|NCT00392808|P3|Participant Flow|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
486908|NCT00392808|P2|Participant Flow|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
486909|NCT00392808|P1|Participant Flow|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
486910|NCT00392808|O4|Outcome|MENC-CRM/MENC-CRM|Children primed with 3 doses of MenC-CRM vaccine, and boosted with MenC-CRM vaccine
486911|NCT00392808|O3|Outcome|MENC-CRM/MENC-TT|Children Primed with three doses of MenC-CRM vaccine and boosted with MenC-TT
486912|NCT00392808|O2|Outcome|MENC-TT/MENC-CRM|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-CRM vaccine
486913|NCT00392808|O1|Outcome|MENC-TT/MENC-TT|Children primovacccinated with two MenC-TT vaccine doses and primed with MenC-TT vaccine
486922|NCT00392782|B1|Baseline|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486923|NCT00392782|P1|Participant Flow|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486924|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486925|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486926|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486927|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486928|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486929|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486930|NCT00392782|O1|Outcome|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486931|NCT00392782|E1|Reported Event|All Treated Patients|"Includes patients with partial matched unrelated donor transplants and treated with: total body irradiation twice daily on days -10 and -9 and receive thiotepa intravenously (IV) over 4 hours on days -8 and -7, fludarabine phosphate IV over 30-60 minutes on days -7 to -3, and antithymocyte globulin IV over 4-6 hours on days -5 to -2.~Patients undergo filgrastim (G-CSF)-mobilized, T-cell-depleted, CD34+-selected allogeneic PBSC transplantation on day 0."
486932|NCT00392769|B1|Baseline|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
486933|NCT00392769|P1|Participant Flow|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
486934|NCT00392769|O1|Outcome|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
486935|NCT00392769|E1|Reported Event|Cetuximab|400 mg/m^2 intravenous (IV) over 120 Minutes, followed by weekly infusions at 250 mg/m^2 IV over 60 minutes.
486936|NCT00392704|B1|Baseline|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
486937|NCT00392704|P1|Participant Flow|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
486988|NCT00392444|O1|Outcome|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
486938|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
486939|NCT00392704|O1|Outcome|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
486940|NCT00392704|E1|Reported Event|Intervention|"All patients initially received treatment with paclitaxel 200 mg/m2, 3 hour IV infusion days 1 and 22; carboplatin area under the curve (AUC) 6.0 IV, days 1 and 22; 5-fluorouracil (5-FU) 200 mg/m2 daily by 24-hour continuous IV infusion, days 1 to 43; bevacizumab 15 mg/kg IV infusion days 1 and 22.~One to three weeks after completing neoadjuvant therapy, patients began treatment with concurrent chemoradiation, bevacizumab, and erlotinib. Radiation therapy began on day 1, with 1.8-Gy single daily doses, Monday through Friday, to a total dose of 68.4 Gy. Paclitaxel 50 mg/m2 was administered by 1-hour IV infusion on days 1 and 22. Erlotinib 150 mg by mouth daily began concurrently with radiation therapy and continued daily during the 7-week course of radiation."
486941|NCT00392678|B5|Baseline|Total|Total of all reporting groups
486942|NCT00392678|B4|Baseline|Placebo|
486943|NCT00392678|B3|Baseline|Salsalate 4.0 g/d|
486944|NCT00392678|B2|Baseline|Salsalate 3.5 g/d|
486945|NCT00392678|B1|Baseline|Salsalate 3.0 g/d|
486946|NCT00392678|P4|Participant Flow|Placebo|
486947|NCT00392678|P3|Participant Flow|Salsalate 4.0 g/d|
486948|NCT00392678|P2|Participant Flow|Salsalate 3.5 g/d|
486949|NCT00392678|P1|Participant Flow|Salsalate 3.0 g/d|
486950|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486951|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486952|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486953|NCT00392678|O1|Outcome|Placebo|Placebo
486954|NCT00392678|O4|Outcome|Placebo|Placebo
486955|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486956|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486957|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486958|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486959|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486960|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486961|NCT00392678|O1|Outcome|Placebo|Placebo
486962|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486963|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486964|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486965|NCT00392678|O1|Outcome|Placebo|Placebo
486966|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486967|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486968|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486969|NCT00392678|O1|Outcome|Placebo|Placebo
486970|NCT00392678|O4|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486971|NCT00392678|O3|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486972|NCT00392678|O2|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486973|NCT00392678|O1|Outcome|Placebo|Placebo
486974|NCT00392678|O4|Outcome|Placebo|Placebo
486975|NCT00392678|O3|Outcome|Salsalate 4.0 g/d|Salsalate 4.0 g/d, divided
486976|NCT00392678|O2|Outcome|Salsalate 3.5 g/d|Salsalate 3.5 g/d, divided
486977|NCT00392678|O1|Outcome|Salsalate 3.0 g/d|Salsalate 3.0 g/d, divided
486978|NCT00392678|E4|Reported Event|Placebo|
486979|NCT00392678|E3|Reported Event|Salsalate 4.0 g/d|
486980|NCT00392678|E2|Reported Event|Salsalate 3.5 g/d|
486981|NCT00392678|E1|Reported Event|Salsalate 3.0 g/d|
486982|NCT00392496|B1|Baseline|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
486983|NCT00392496|P1|Participant Flow|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
486984|NCT00392496|O1|Outcome|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
486985|NCT00392496|E1|Reported Event|Arm I|This is a non-randomized, open-label, multicenter study. Patients receive sunitinib malate orally once daily on days 1-28. Treatment repeats every 4 weeks for a maximum of 12 courses in the absence of disease progression or unacceptable toxicity.
486986|NCT00392444|B1|Baseline|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
486987|NCT00392444|P1|Participant Flow|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
487139|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
486989|NCT00392444|E1|Reported Event|Treatment (Sunitinib Malate)|Patients receive oral sunitinib malate once daily on days 1-28. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity.
486990|NCT00392392|B1|Baseline|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
486991|NCT00392392|P1|Participant Flow|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
486992|NCT00392392|O1|Outcome|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
486993|NCT00392392|E1|Reported Event|Nab-Paclitaxel/Bevacizumab/Trastuzumab|Patients received treatment with nab-paclitaxel (100 mg/m2 IV days 1, 8, 15) and carboplatin (AUC 6 IV day 1) every 28 days for 6 cycles. Trastuzumab (4 mg/kg loading dose, followed by 2 mg/kg) and bevacizumab (5 mg/kg IV) were administered weekly for 23 weeks, beginning concurrently with chemotherapy. Patients then underwent either mastectomy or breast conserving surgery and pathologic treatment responses were assessed. After surgery, trastuzumab 6 mg/kg and bevacizumab 15 mg/kg were administered at 3 week intervals for a total of 52 weeks.
486994|NCT00392379|B3|Baseline|Total|Total of all reporting groups
486995|NCT00392379|B2|Baseline|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
486996|NCT00392379|B1|Baseline|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
486997|NCT00392379|P2|Participant Flow|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
486998|NCT00392379|P1|Participant Flow|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
486999|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487000|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487001|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487002|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487038|NCT00392223|P2|Participant Flow|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487039|NCT00392223|P1|Participant Flow|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487003|NCT00392379|O2|Outcome|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487004|NCT00392379|O1|Outcome|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487005|NCT00392379|E2|Reported Event|Placebo Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487006|NCT00392379|E1|Reported Event|Nicotine Lozenge|Medication was given for 12 weeks. All subjects were instructed to quit all tobacco products and start using lozenges the following day. For weeks 1 through 6, subjects were instructed to use one lozenge orally every 1 to 2 hours with a maximum of 16 lozenges per day. After 6 weeks, lozenges were tapered. For weeks 7 through 9, subjects were instructed to use 8 lozenges per day or one every 2 to 4 hours. For weeks 10 through 12, subjects were instructed to use 4 lozenges per day or one every 4 to 8 hours.
487007|NCT00392288|B4|Baseline|Total|Total of all reporting groups
487008|NCT00392288|B3|Baseline|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487009|NCT00392288|B2|Baseline|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487010|NCT00392288|B1|Baseline|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487011|NCT00392288|P3|Participant Flow|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487012|NCT00392288|P2|Participant Flow|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487013|NCT00392288|P1|Participant Flow|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487014|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487015|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487016|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487017|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487018|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487019|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487020|NCT00392288|O3|Outcome|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487021|NCT00392288|O2|Outcome|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487022|NCT00392288|O1|Outcome|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487023|NCT00392288|E3|Reported Event|Ciclesonide MDI 80 µg BID|Ciclesonide MDI 80 µg BID over twelve weeks (ITT population)
487024|NCT00392288|E2|Reported Event|Ciclesonide MDI 40 µg BID|Ciclesonide MDI 40 µg BID over twelve weeks (ITT population)
487025|NCT00392288|E1|Reported Event|Placebo Metered Dose Inhaler (MDI)|Placebo MDI over twelve weeks (ITT population)
487026|NCT00392236|B3|Baseline|Total|Total of all reporting groups
487027|NCT00392236|B2|Baseline|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
487028|NCT00392236|B1|Baseline|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
487029|NCT00392236|P2|Participant Flow|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
487030|NCT00392236|P1|Participant Flow|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
487031|NCT00392236|O2|Outcome|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
487032|NCT00392236|O1|Outcome|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
487033|NCT00392236|E2|Reported Event|Treatment as Usual|"Participants will receive treatment as usual~Treatment as usual: Participants will receive treatment as usual."
487034|NCT00392236|E1|Reported Event|Pager Group|"Participants will receive treatment as usual and a 2-way pager for 6 months~2-way pager: Participants will receive messages daily to take their medication via a 2-way pager for 6 months. Once the message is received the participant will respond whether or not he/she took the medication and reason for not taking."
487035|NCT00392223|B3|Baseline|Total|Total of all reporting groups
487036|NCT00392223|B2|Baseline|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487037|NCT00392223|B1|Baseline|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487040|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487041|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487042|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487043|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487044|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487045|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487046|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487047|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487048|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487049|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487050|NCT00392223|O2|Outcome|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487051|NCT00392223|O1|Outcome|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487052|NCT00392223|E2|Reported Event|Minocycline|100 milligrams (mg) administered PO (oral) QD (every day) for 8 weeks (minocycline capsules)
487053|NCT00392223|E1|Reported Event|Azithromycin|2 grams per week administered orally (PO) for 8 weeks (azithromycin microspheres, powder for oral suspension)
487054|NCT00392197|B3|Baseline|Total|Total of all reporting groups
487055|NCT00392197|B2|Baseline|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
487056|NCT00392197|B1|Baseline|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
487057|NCT00392197|P2|Participant Flow|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
487058|NCT00392197|P1|Participant Flow|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
487059|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
487060|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
487061|NCT00392197|O2|Outcome|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
487062|NCT00392197|O1|Outcome|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
487063|NCT00392197|E2|Reported Event|Patients Previously Treated With Antipsychotic Drugs|Patients who have taken antipsychotic drugs for 2 years or more and are taking antipsychotic drugs at the time of giving informed consent
487064|NCT00392197|E1|Reported Event|Antipsychotic-naïve Patients|Patients who have never taken antipsychotic drugs or patients who have taken antipsychotic drugs for less than 2 years and have not taken them within a period from at least 12 weeks prior to giving informed consent to immediately before commencement of study drug administration
487065|NCT00392171|B1|Baseline|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
487066|NCT00392171|P1|Participant Flow|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
487067|NCT00392171|O1|Outcome|Temozolomide|Temozolomide will be administered at a dose of 50 mg/m^2 for cycles of 28 days for 12 months or until progression.
487068|NCT00392171|E1|Reported Event|Temozolomide|
487069|NCT00391989|B1|Baseline|Dasatinib|All patients registered in the study.
487070|NCT00391989|P1|Participant Flow|Study Group|All patients registered in the study.
487071|NCT00391989|O1|Outcome|Study Group|All patients registered in the study.
487072|NCT00391989|E1|Reported Event|Dasatinib|All patients registered in the study.
487073|NCT00391976|B4|Baseline|Total|Total of all reporting groups
487074|NCT00391976|B3|Baseline|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487075|NCT00391976|B2|Baseline|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487076|NCT00391976|B1|Baseline|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487077|NCT00391976|P3|Participant Flow|Non-randomized Patients|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487078|NCT00391976|P2|Participant Flow|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487079|NCT00391976|P1|Participant Flow|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487080|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487081|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487082|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487083|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487084|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487085|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487086|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487087|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487088|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487089|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487090|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487091|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487092|NCT00391976|O3|Outcome|Non-randomized|Patients who started the study and received tobramycin 300 mg twice a day for 28 days, but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups. These patients were not included in the efficacy analyses.
487093|NCT00391976|O2|Outcome|Tobramycin 300 mg for 56 Days|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487094|NCT00391976|O1|Outcome|Tobramycin 300 mg for 28 Days|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487095|NCT00391976|E5|Reported Event|Tobramycin 56 Days After Month 3|Patients received tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
487096|NCT00391976|E4|Reported Event|Tobramycin 28 Days After Month 3|Patients who received tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. Patients received no study medication during the follow-up phase (from Month 3 though Month 27).
487097|NCT00391976|E3|Reported Event|Non-randomized Patients up to Month 3|Patients who started the study and received tobramycin 300 mg twice a day for 28 days but tested positive for antibodies to any of 3 Pseudomonas aeruginosa exoenzymes in a blood sample collected at baseline were not randomized into the treatment groups.
487098|NCT00391976|E2|Reported Event|Tobramycin 56 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 56 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487099|NCT00391976|E1|Reported Event|Tobramycin 28 Days Up To Month 3|Patients inhaled tobramycin 300 mg twice a day for 28 days using the PARI LC PLUS™ jet nebulizer and a suitable compressor. The 2 daily doses were taken approximately 12 hours apart and no less than 6 hours apart.
487100|NCT00391898|B3|Baseline|Total|Total of all reporting groups
487101|NCT00391898|B2|Baseline|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487102|NCT00391898|B1|Baseline|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487103|NCT00391898|P2|Participant Flow|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487104|NCT00391898|P1|Participant Flow|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487105|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487106|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487107|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487108|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487109|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487110|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487111|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487112|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487113|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487114|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487115|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487116|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487117|NCT00391898|O2|Outcome|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487118|NCT00391898|O1|Outcome|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487119|NCT00391898|E2|Reported Event|Levodopa/Carbidopa|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.
487120|NCT00391898|E1|Reported Event|Levodopa/Carbidopa/Entacapone|Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets.
487121|NCT00391872|B3|Baseline|Total|Total of all reporting groups
487122|NCT00391872|B2|Baseline|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487123|NCT00391872|B1|Baseline|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487124|NCT00391872|P2|Participant Flow|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487125|NCT00391872|P1|Participant Flow|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487126|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487127|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487128|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487129|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487130|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487131|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487132|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487133|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487134|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487135|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487136|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487140|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487141|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487142|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487143|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487144|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487145|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487146|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487147|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487148|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487149|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487150|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487151|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487152|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487153|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487154|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487155|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487156|NCT00391872|O2|Outcome|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487157|NCT00391872|O1|Outcome|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487158|NCT00391872|E2|Reported Event|CLOPIDOGREL|Clopidogrel 75 mg once daily dose (ODD)
487159|NCT00391872|E1|Reported Event|TICAGRELOR|Ticagrelor 90 mg twice daily dose (BD)
487160|NCT00391846|B3|Baseline|Total|Total of all reporting groups
487161|NCT00391846|B2|Baseline|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487162|NCT00391846|B1|Baseline|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487163|NCT00391846|P2|Participant Flow|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487164|NCT00391846|P1|Participant Flow|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487165|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487166|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487167|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487168|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487169|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487170|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487171|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487172|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487173|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487174|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487175|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487176|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487177|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487178|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487179|NCT00391846|O2|Outcome|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487180|NCT00391846|O1|Outcome|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487181|NCT00391846|E2|Reported Event|Not Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms and signs
487182|NCT00391846|E1|Reported Event|Guided by NT-proBNP|Chronic heart failure treatment guided by clinical symptoms, signs and NT-proBNP
487183|NCT00391807|B1|Baseline|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487184|NCT00391807|P1|Participant Flow|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487185|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487186|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487187|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487188|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487189|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487190|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487240|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
488865|NCT00386334|O1|Outcome|Placebo|Placebo tablets
487191|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487192|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487193|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487194|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487195|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487196|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487197|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487198|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487199|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487200|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487201|NCT00391807|O1|Outcome|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487202|NCT00391807|E1|Reported Event|Norethindrone/Ethinyl Estradiol|1 tablet norethindrone acetate (NETA) 1mg/ethinyl estradiol (EE)10 mcg daily for 24 days, 1 EE 10 mcg tablet daily for 2 days, 1 inactive ferrous fumarate tablet daily for 2 days
487203|NCT00391768|B8|Baseline|Total|Total of all reporting groups
487204|NCT00391768|B7|Baseline|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487205|NCT00391768|B6|Baseline|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487206|NCT00391768|B5|Baseline|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487207|NCT00391768|B4|Baseline|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487208|NCT00391768|B3|Baseline|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487209|NCT00391768|B2|Baseline|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487210|NCT00391768|B1|Baseline|Cohort IA|12 - 23 months of age, 30 mg
487211|NCT00391768|P7|Participant Flow|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487212|NCT00391768|P6|Participant Flow|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487213|NCT00391768|P5|Participant Flow|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487214|NCT00391768|P4|Participant Flow|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487215|NCT00391768|P3|Participant Flow|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487216|NCT00391768|P2|Participant Flow|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487217|NCT00391768|P1|Participant Flow|Cohort IA|12 - 23 months of age, 30 mg
487218|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487219|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487220|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487221|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487222|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487223|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487224|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
487225|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487226|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487227|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487228|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487229|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487230|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
487231|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
487232|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487233|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487234|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487235|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487236|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487237|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487238|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
487239|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487241|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487242|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487243|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487244|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487245|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
487246|NCT00391768|O7|Outcome|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487247|NCT00391768|O6|Outcome|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487248|NCT00391768|O5|Outcome|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487249|NCT00391768|O4|Outcome|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487250|NCT00391768|O3|Outcome|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487251|NCT00391768|O2|Outcome|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487252|NCT00391768|O1|Outcome|Cohort IA|12 - 23 months of age, 30 mg
487253|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487254|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487255|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487256|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
487257|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487258|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days
487259|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days
487260|NCT00391768|O7|Outcome|Cohort V|Subjects aged 0 - 2 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487261|NCT00391768|O6|Outcome|Cohort IV|Subjects aged 3 - 5 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days
487262|NCT00391768|O5|Outcome|Cohort III|Subjects aged 6 - 8 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
487263|NCT00391768|O4|Outcome|Cohort IIB|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
487264|NCT00391768|O3|Outcome|Cohort IIA|Subjects aged 9 - 11 months of age confirmed to have influenza. These subjects received 3 mg/kg body weight of Oseltamivir twice a day times 5 days.
487265|NCT00391768|O2|Outcome|Cohort IB|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 3.5 mg/kg body weight of Oseltamivir twice a day times 5 days.
487266|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 - 23 months of age confirmed to have influenza. These subjects received 30 mg of Oseltamivir twice a day times 5 days.
487267|NCT00391768|O7|Outcome|Cohort V|Subjects 0 to 2 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487268|NCT00391768|O6|Outcome|Cohort IV|Subjects 3 to 5 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487269|NCT00391768|O5|Outcome|Cohort III|Subjects 6 to 8 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487270|NCT00391768|O4|Outcome|Cohort IIB|Subjects 9 to 11 months of age confirmed to have influenza and received 3.5 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487271|NCT00391768|O3|Outcome|Cohort IIA|Subjects 9 to 11 months of age confirmed to have influenza and received 3 mg/kg body weight of Oseltamivir by mouth twice a day times 5 days.
487272|NCT00391768|O2|Outcome|Cohort IB|Subjects 12 to 23 months of age confirmed to have influenza and received 3.5 mg/kg of Oseltamivir by mouth twice a day times 5 days.
487273|NCT00391768|O1|Outcome|Cohort IA|Subjects aged 12 to 23 months of age confirmed to have influenza. These subjects received 30mg of Oseltamivir twice a day times 5 days.
487274|NCT00391768|E7|Reported Event|Cohort V|0 to 2 months of age, 3 mg/kg body weight
487275|NCT00391768|E6|Reported Event|Cohort IV|3 to 5 months of age, 3 mg/kg body weight
487276|NCT00391768|E5|Reported Event|Cohort III|6 to 8 months of age, 3 mg/kg body weight
487277|NCT00391768|E4|Reported Event|Cohort IIB|9 to 11 months of age, 3.5 mg/kg body weight
487278|NCT00391768|E3|Reported Event|Cohort IIA|9 - 11 months of age, 3 mg/kg body weight
487279|NCT00391768|E2|Reported Event|Cohort IB|12 - 23 months of age, 3.5 mg/kg body weight
487280|NCT00391768|E1|Reported Event|Cohort IA|12 - 23 months of age, 30 mg
487281|NCT00391716|B4|Baseline|Total|Total of all reporting groups
487282|NCT00391716|B3|Baseline|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487283|NCT00391716|B2|Baseline|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487284|NCT00391716|B1|Baseline|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487285|NCT00391716|P3|Participant Flow|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487286|NCT00391716|P2|Participant Flow|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487287|NCT00391716|P1|Participant Flow|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487288|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487289|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487290|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487291|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487292|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487293|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487294|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487295|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487296|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487297|NCT00391716|O3|Outcome|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487298|NCT00391716|O2|Outcome|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487299|NCT00391716|O1|Outcome|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487300|NCT00391716|E3|Reported Event|Placebo Daily|"placebo capsules daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~placebo: lactose capsule compounded to mimic gabapentin capsules"
487301|NCT00391716|E2|Reported Event|Gabapentin 1800mg Daily|"1800 mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info.~gabapentin 1800mg: 1800 mg gabapentin daily for 12 weeks"
487302|NCT00391716|E1|Reported Event|Gabapentin 900mg Daily|"900mg gabapentin daily for 12 weeks and weekly concomitant manualized behavioral counseling for 12 weeks.~Gabapentin 900mg: 900 mg gabapentin daily for 12 weeks~behavioral counseling: The manual for standardized alcohol-related behavioral counseling was developed by Drs. Barbara Mason and Anita Goodman. The manual is available at alcoholfree.info."
487303|NCT00391625|B1|Baseline|GA-GCB|15-60 U/kg every other week via intravenous infusion
487304|NCT00391625|P1|Participant Flow|GA-GCB|15-60 U/kg every other week via intravenous infusion
487305|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
487306|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
487307|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
487308|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
487309|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
487310|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
487311|NCT00391625|O6|Outcome|GA-GCB: Month 81|15-60 U/kg, every other week Intravenously
487312|NCT00391625|O5|Outcome|GA-GCB: Month 69|15-60 U/kg, every other week Intravenously
487313|NCT00391625|O4|Outcome|GA-GCB: Month 57|15-60 U/kg, every other week Intravenously
487314|NCT00391625|O3|Outcome|GA-GCB: Month 45|15-60 U/kg, every other week Intravenously
487315|NCT00391625|O2|Outcome|GA-GCB: Month 33|15-60 U/kg, every other week Intravenously
487316|NCT00391625|O1|Outcome|GA-GCB: Month 24|15-60 U/kg, every other week Intravenously
487317|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
487318|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
487319|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
487320|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
487321|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
487322|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
487323|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
487324|NCT00391625|O7|Outcome|GA-GCB: 84 Months|15-60 U/kg, every other week Intravenously
487325|NCT00391625|O6|Outcome|GA-GCB: 72 Months|15-60 U/kg, every other week Intravenously
487326|NCT00391625|O5|Outcome|GA-GCB: 60 Months|15-60 U/kg, every other week Intravenously
487327|NCT00391625|O4|Outcome|GA-GCB-48 Months|15-60 U/kg, every other week Intravenously
487328|NCT00391625|O3|Outcome|GA-GCB: 36 Months|15-60 U/kg, every other week Intravenously
487329|NCT00391625|O2|Outcome|GA-GCB: 24 Months|15-60 U/kg, every other week Intravenously
487330|NCT00391625|O1|Outcome|GA-GCB: 12 Months|15-60 U/kg, every other week Intravenously
487331|NCT00391625|O11|Outcome|# Deaths|
487332|NCT00391625|O10|Outcome|# Discontinued Due to an AE|15-60 U/kg, every other week Intravenously
487333|NCT00391625|O9|Outcome|# Experienced at Least 1 Drug-related Serious AE|15-60 U/kg, every other week Intravenously
487334|NCT00391625|O8|Outcome|# Experienced at Least 1 Serious AE|15-60 U/kg, every other week Intravenously
487335|NCT00391625|O7|Outcome|# Experienced at Least 1 Life-threatening AE|15-60 U/kg, every other week Intravenously
487336|NCT00391625|O6|Outcome|# Experienced at Least 1 Drug-related Severe AE|15-60 U/kg, every other week Intravenously
487337|NCT00391625|O5|Outcome|# Experienced at Least 1 Severe AE|15-60 U/kg, every other week Intravenously
487338|NCT00391625|O4|Outcome|# Experienced at Least 1 Infusion-related AE|15-60 U/kg, every other week Intravenously
487339|NCT00391625|O3|Outcome|# Experienced at Least 1 Drug-related AE|15-60 U/kg, every other week Intravenously
487340|NCT00391625|O2|Outcome|# Experienced at Least 1 AE|15-60 U/kg, every other week Intravenously
487341|NCT00391625|O1|Outcome|Number (#) Experienced no Adverse Event (AE)|15-60 U/kg every other week via intravenous infusion
487342|NCT00391625|E1|Reported Event|GA-GCB|
487343|NCT00391599|B3|Baseline|Total|Total of all reporting groups
487344|NCT00391599|B2|Baseline|Control Group|no preoperative intestinal preparation.
487345|NCT00391599|B1|Baseline|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
487346|NCT00391599|P2|Participant Flow|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
487347|NCT00391599|P1|Participant Flow|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
487348|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
487349|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
487350|NCT00391599|O2|Outcome|Control Group|"no preoperative intestinal preparation.~enema"
487351|NCT00391599|O1|Outcome|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema"
487352|NCT00391599|O2|Outcome|Control Group|The patients had no preoperative intestinal preparation on the night before cesarean section
487353|NCT00391599|O1|Outcome|Study Group|The patients were given a Fleet enema (250 cm3 of sodium biphosphate 16 g and sodium phosphate 6 g/100 cm3) the night before cesarean section
487354|NCT00391599|E2|Reported Event|Control Group|"no preoperative intestinal preparation.~the night before cesarean section"
487355|NCT00391599|E1|Reported Event|Study Group|"a fleet enema (250 cc of sodium biphosphate 16 gr and sodium phosphate 6 gr per 100 cc) the night before cesarean section~enema~the night before cesarean section"
487356|NCT00391586|B1|Baseline|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
487357|NCT00391586|P1|Participant Flow|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
487358|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
488233|NCT00389064|P1|Participant Flow|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
487359|NCT00391586|O1|Outcome|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
487360|NCT00391586|E1|Reported Event|Erlotinib Followed by Chemotherapy|Erlotinib at 150 mg orally per day for at least 2 cycles (6 weeks) and for a maximum of 8 months. Upon progression or drug intolerance, this is followed by standard of care platinum-based chemotherapy selected by the treating physician, every 3 weeks for at least 2 cycles
487361|NCT00391469|B5|Baseline|Total|Total of all reporting groups
487362|NCT00391469|B4|Baseline|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487363|NCT00391469|B3|Baseline|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
487364|NCT00391469|B2|Baseline|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487365|NCT00391469|B1|Baseline|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
487366|NCT00391469|P2|Participant Flow|Control|standard of care
487367|NCT00391469|P1|Participant Flow|Intervention|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487368|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487369|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
487370|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487371|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
487372|NCT00391469|O4|Outcome|Non-VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487373|NCT00391469|O3|Outcome|Non-VF Randomized to Standard Treatment|standard treatment following non-VF cardiac arrest
487374|NCT00391469|O2|Outcome|VF-randomized to Hypothermia|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487375|NCT00391469|O1|Outcome|VF-randomized to Standard Treatment|standard treatment following VF cardiac arrest
487376|NCT00391469|E2|Reported Event|Control-standard Care|standard care
487377|NCT00391469|E1|Reported Event|Intervention-hypo|"Rapid infusion of 2 liters of 4oC normal saline: Patients randomized to mild hypothermia will receive a rapid infusion of 2 liters of 4oC normal saline prior to arrival in the emergency room. Patients randomized to control will receive standard of care following resuscitation from cardiac arrest.~Rapid infusion of cold normal saline"
487378|NCT00391443|B3|Baseline|Total|Total of all reporting groups
487379|NCT00391443|B2|Baseline|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487380|NCT00391443|B1|Baseline|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487381|NCT00391443|P2|Participant Flow|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487382|NCT00391443|P1|Participant Flow|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487383|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487384|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487385|NCT00391443|O2|Outcome|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487386|NCT00391443|O1|Outcome|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487387|NCT00391443|E2|Reported Event|Bosentan|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487462|NCT00391222|P4|Participant Flow|Open-label Risperidone LAI|Open-label Period II: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days
487388|NCT00391443|E1|Reported Event|Placebo|Initial dose: 62.5 mg twice daily (b.i.d.) for 4 weeks. Target dose: - body weight > 40 kg (90 lb): 125 mg b.i.d., (if the initial dose is well tolerated); - body weight < 40 kg (90 lb): 62.5 mg b.i.d.
487389|NCT00391391|B5|Baseline|Total|Total of all reporting groups
487390|NCT00391391|B4|Baseline|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487391|NCT00391391|B3|Baseline|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487392|NCT00391391|B2|Baseline|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487393|NCT00391391|B1|Baseline|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487394|NCT00391391|P4|Participant Flow|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487395|NCT00391391|P3|Participant Flow|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487396|NCT00391391|P2|Participant Flow|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487397|NCT00391391|P1|Participant Flow|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487398|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487399|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487400|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487401|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487402|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487403|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487404|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487405|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487406|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487407|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487408|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487409|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487410|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487411|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487412|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487413|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487414|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487415|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487416|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487417|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487418|NCT00391391|O4|Outcome|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487419|NCT00391391|O3|Outcome|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487420|NCT00391391|O2|Outcome|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487421|NCT00391391|O1|Outcome|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487422|NCT00391391|E4|Reported Event|Group 4: Fluzone IM 3 to 8 Years Age|Participants at age 3 to 8 years on enrollment that received Fluzone IM vaccine
487423|NCT00391391|E3|Reported Event|Group 3: Fluzone ID at 3 to 8 Years Age|Participants at Age 3 to 8 Years on enrollment that received Fluzone ID vaccine
487424|NCT00391391|E2|Reported Event|Group 2: Fluzone IM 6 to 35 Months Age Group|Participants at 6 to 35 Months Age on enrollment that received Fluzone IM vaccine
487425|NCT00391391|E1|Reported Event|Group 1: Fluzone ID at Age 6 to 35 Months|Participants at 6 to 35 Months of age on enrollment that received Fluzone ID vaccine
487426|NCT00391365|B3|Baseline|Total|Total of all reporting groups
487427|NCT00391365|B2|Baseline|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487463|NCT00391222|P3|Participant Flow|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487464|NCT00391222|P2|Participant Flow|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
488234|NCT00389064|O2|Outcome|Placebo|
487428|NCT00391365|B1|Baseline|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487429|NCT00391365|P2|Participant Flow|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487430|NCT00391365|P1|Participant Flow|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487431|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
487432|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
487433|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis.
487434|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
487435|NCT00391365|O2|Outcome|Ankle Arthroplasty (Replacement)|Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis
487436|NCT00391365|O1|Outcome|Ankle Arthrodesis (Fusion)|Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis
487437|NCT00391365|E2|Reported Event|Ankle Arthroplasty (Replacement)|"Subjects undergoing ankle arthroplasty (replacement) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487438|NCT00391365|E1|Reported Event|Ankle Arthrodesis (Fusion)|"Subjects undergoing ankle arthrodesis (fusion) for treatment of ankle arthritis~Gait analysis: Subjects will come into motion analysis laboratory at the VA Puget Sound Health Care System. A standard set of body measurements will be taken using calipers, a measuring tape, and a scale (for example height, weight, leg length, foot length, etc). The investigators will then attach small reflective markers to the body using double-sided tape and ask the participants to walk several times as the motion of each marker is recorded by infrared cameras."
487439|NCT00391274|B3|Baseline|Total|Total of all reporting groups
487440|NCT00391274|B2|Baseline|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487441|NCT00391274|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487442|NCT00391274|P2|Participant Flow|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487443|NCT00391274|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487444|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487445|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487446|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487447|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487448|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487449|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487450|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487451|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487452|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487453|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487454|NCT00391274|O2|Outcome|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487455|NCT00391274|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487456|NCT00391274|E2|Reported Event|Docetaxel|75 mg/m2, intravenous (IV), every 21 days until disease progression, death or 12 months after enrollment.
487457|NCT00391274|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV) every 21 days until disease progression, death or 12 months after enrollment.
487458|NCT00391222|B4|Baseline|Total|Total of all reporting groups
487459|NCT00391222|B3|Baseline|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine 10 mg/day
487460|NCT00391222|B2|Baseline|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487461|NCT00391222|B1|Baseline|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable intramuscular every 14 days and oral placebo daily
487465|NCT00391222|P1|Participant Flow|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487466|NCT00391222|O1|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487467|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487468|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487469|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487470|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487471|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487472|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487473|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487474|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487475|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487476|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487477|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487478|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487479|NCT00391222|O3|Outcome|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487480|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487481|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487482|NCT00391222|O2|Outcome|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487483|NCT00391222|O1|Outcome|Risperidone LAI|Double-blind Period III: risperidone long-acting injectable 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487484|NCT00391222|E4|Reported Event|Open-label Risperidone LAI|risperidone 25, 37.5, or 50 mg intramuscular every 14 days
487485|NCT00391222|E3|Reported Event|Olanzapine|Double-blind Period III: placebo injections every 14 days and oral olanzapine daily
487486|NCT00391222|E2|Reported Event|Placebo|Double-blind Period III: placebo injections every 14 days and oral placebo daily
487487|NCT00391222|E1|Reported Event|Risperidone LAI|Double-blind Period III: risperidone LAI 25, 37.5 or 50 mg intramuscular every 14 days and oral placebo daily
487488|NCT00391092|B3|Baseline|Total|Total of all reporting groups
487489|NCT00391092|B2|Baseline|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487490|NCT00391092|B1|Baseline|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487491|NCT00391092|P2|Participant Flow|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487492|NCT00391092|P1|Participant Flow|Trastuzumab + Docetaxel|Trastuzumab 8 milligrams per kilogram (mg/kg) loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 milligrams per square meter (mg/m^2) on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487493|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487494|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487495|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487514|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487496|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487497|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487498|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487499|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487500|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487501|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487502|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487503|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487504|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487505|NCT00391092|O2|Outcome|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487506|NCT00391092|O1|Outcome|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487507|NCT00391092|E2|Reported Event|Trastuzumab + Bevacizumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by bevacizumab 15 mg/kg and docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg, bevacizumab 15 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent.
487508|NCT00391092|E1|Reported Event|Trastuzumab + Docetaxel|Trastuzumab 8 mg/kg loading dose administered intravenously on Day 1 of Cycle 1, followed by docetaxel 100 mg/m^2 on Day 2 of Cycle 1. Then a maintenance dose of trastuzumab at 6 mg/kg and docetaxel at 100 mg/m^2 were administered intravenously on Day 1 of each 3-weekly cycle until disease progression, unacceptable toxicity (requiring discontinuation of study treatment), or withdrawal of participant’s consent, and for a minimum of 6 cycles, respectively.
487509|NCT00391079|B3|Baseline|Total|Total of all reporting groups
487510|NCT00391079|B2|Baseline|Placebo|Range of 8-12 sprays per day of placebo spray.
487511|NCT00391079|B1|Baseline|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487512|NCT00391079|P2|Participant Flow|Placebo|Range of 8-12 sprays per day of placebo spray.
487513|NCT00391079|P1|Participant Flow|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487515|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487516|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487517|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487518|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487519|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487520|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487521|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487522|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487523|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487524|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487525|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487526|NCT00391079|O2|Outcome|Placebo|Range of 8-12 sprays of placebo per day
487527|NCT00391079|O1|Outcome|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487528|NCT00391079|E2|Reported Event|Placebo|Range of 8-12 sprays of placebo per day
487529|NCT00391079|E1|Reported Event|Sativex|Range of 8 -12 sprays per day. Each actuation of oromucosal spray delivers 2.7 mg delta-9-tetrahydrocannabinol (THC) and 2.5 mg cannabidiol (CBD). Thus maximum daily dose is 32.4 mg THC and 30 mg CBD.
487530|NCT00391053|B5|Baseline|Total|Total of all reporting groups
487531|NCT00391053|B4|Baseline|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487532|NCT00391053|B3|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487533|NCT00391053|B2|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487534|NCT00391053|B1|Baseline|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487535|NCT00391053|P4|Participant Flow|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487536|NCT00391053|P3|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487537|NCT00391053|P2|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487538|NCT00391053|P1|Participant Flow|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487539|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487540|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487541|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487542|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487543|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487544|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487545|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487546|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487547|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487548|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487549|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487899|NCT00390221|P1|Participant Flow|Placebo|Placebo administered as 3 subcutaneous (SC) injections every 4 weeks for up to 52 weeks
487550|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487551|NCT00391053|O4|Outcome|Active Comparator (Standard Fluzone®)|Participants aged 65 years or older at enrollment, treated with standard Fluzone® vaccine 2006-2007 formulation
487552|NCT00391053|O3|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 3
487553|NCT00391053|O2|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 2
487554|NCT00391053|O1|Outcome|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|Participants aged 65 years or older at enrollment, treated with high-dose trivalent inactivated influenza vaccine (Fluzone HD) 2006-2007 formulation, Lot 1
487555|NCT00391053|E4|Reported Event|Standad Dose Inactivated, Split-Virion Influenza Vaccine|
487556|NCT00391053|E3|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 3|
487557|NCT00391053|E2|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 2|
487558|NCT00391053|E1|Reported Event|High-Dose Inactivated, Split-Virion Influenza Vaccine Lot 1|
487559|NCT00391027|B3|Baseline|Total|Total of all reporting groups
487560|NCT00391027|B2|Baseline|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487561|NCT00391027|B1|Baseline|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487562|NCT00391027|P2|Participant Flow|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487563|NCT00391027|P1|Participant Flow|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487564|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487565|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487566|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487567|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487568|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487614|NCT00390858|B2|Baseline|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487569|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487570|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487571|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487572|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487573|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487574|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487575|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487576|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487577|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487578|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487579|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487580|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487615|NCT00390858|B1|Baseline|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487581|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487582|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487583|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487584|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487585|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487586|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487587|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487588|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487589|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487590|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487591|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487592|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487616|NCT00390858|P2|Participant Flow|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487593|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487594|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487595|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487596|NCT00391027|O2|Outcome|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487597|NCT00391027|O1|Outcome|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487598|NCT00391027|E2|Reported Event|Insulin Glargine (Lantus®)|Insulin glargine (Lantus®) 10 International Units (IU) injected subcutaneously (SC) once daily (QD) at the same time of day (morning dose recommended) for the duration of the study (26 Weeks) using a pen device where available. Daily dose of insulin glargine modified based on glucose measurements at the discretion of the treating physician. Insulin glargine added initially to subject's usual oral regimen and was to be continued at pre-study doses unless clinical need justified a dose modification.
487599|NCT00391027|E1|Reported Event|Inhaled Human Insulin (Exubera®)|Pre-prandial inhaled insulin regimen administered three times a day (TID) using Exubera® Inhaler device; insulin packaged as 1 or 3 milligram (mg) dry powder insulin. Initial daily dose determined based on subject's body weight and divided into 3 doses administered prior to major meals. Pre-meal doses modified based on meal size and pre-prandial blood glucose readings. Subjects combined 1 and 3 mg doses before each meal to control post-prandial glycemia in addition to continuing their usual oral (PO) drugs at the pre-study doses unless clinical need justified a dose modification.
487600|NCT00390884|B3|Baseline|Total|Total of all reporting groups
487601|NCT00390884|B2|Baseline|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487602|NCT00390884|B1|Baseline|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487603|NCT00390884|P2|Participant Flow|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487604|NCT00390884|P1|Participant Flow|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487605|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487606|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487607|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487608|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487609|NCT00390884|O2|Outcome|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487610|NCT00390884|O1|Outcome|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487611|NCT00390884|E2|Reported Event|Fluzone®-Naive Group|Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487612|NCT00390884|E1|Reported Event|Fluzone®-Primed Group|Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
487613|NCT00390858|B3|Baseline|Total|Total of all reporting groups
487617|NCT00390858|P1|Participant Flow|Children ( < 12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487618|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487619|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487620|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487621|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487622|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487623|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487624|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487625|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487626|NCT00390858|O2|Outcome|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487627|NCT00390858|O1|Outcome|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters (e.g. renal and hematology) and whether Liver Iron Concentration (LIC), and serum ferritin were increasing or decreasing
487628|NCT00390858|E2|Reported Event|Adolescents ( ≧12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
487629|NCT00390858|E1|Reported Event|Children (<12 Years)|Deferasirox was given orally once daily, 30 minutes prior to breakfast. An initial daily dose of 10 mg/kg was used during the 1-year core study. In this 4-year extension study dose modifications of ± 5 or 10 mg/kg were based on safety parameters ( renal and hematology) and whether Liver Iron Concentration (LIC) and serum ferritin were increasing or decreasing
487630|NCT00390806|B3|Baseline|Total|Total of all reporting groups
487631|NCT00390806|B2|Baseline|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487632|NCT00390806|B1|Baseline|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487633|NCT00390806|P2|Participant Flow|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487718|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487719|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487720|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487721|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487722|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487634|NCT00390806|P1|Participant Flow|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487635|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487636|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487637|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487638|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487639|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487640|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487641|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487642|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487643|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487644|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487645|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487646|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487647|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487723|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487724|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487725|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487648|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487649|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487650|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487651|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487652|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487653|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487654|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487655|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487656|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487657|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487658|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487659|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487660|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487661|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487726|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487727|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487728|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
488866|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
487662|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487663|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487664|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487665|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487666|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487667|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487668|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487669|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487670|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487671|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487672|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487673|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487674|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487675|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487729|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487730|NCT00390780|E2|Reported Event|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487731|NCT00390780|E1|Reported Event|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487676|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487677|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487678|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487679|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487680|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487681|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487682|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487683|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487684|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487685|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487686|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487687|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487688|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487689|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487732|NCT00390689|B4|Baseline|Total|Total of all reporting groups
487828|NCT00390559|P1|Participant Flow|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
487690|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487691|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487692|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487693|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487694|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487695|NCT00390806|O2|Outcome|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487696|NCT00390806|O1|Outcome|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487697|NCT00390806|E2|Reported Event|Radiation: WBRT Alone|Participants received WBRT 3 Gy/day for 10 days. Participants may have received other chemotherapies or best supportive care, as determined by the investigator.
487698|NCT00390806|E1|Reported Event|Chemoradiation: Topotecan Plus WBRT|Participants received topotecan 1.1 milligrams per meters squared per day (mg/m2/day), orally followed approximately 2 hours later by whole-brain radiation therapy (WBRT) 3 Gray (Gy)/day to midline over the course of 10 days. After a 2-week washout period, participants completing chemoradiation and willing to participate in the Continuation Phase of the study received oral topotecan 2.3 mg/m2/day for 5 days, every 21 days, as monotherapy provided the baseline hematologic requirements were met. Monotherapy continued until disease progression or discontinuation. Chemoradiation participants choosing not to participate in the Continuation Phase may have received other chemotherapies or best supportive care, as determined by the investigator.
487699|NCT00390780|B3|Baseline|Total|Total of all reporting groups
487700|NCT00390780|B2|Baseline|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487701|NCT00390780|B1|Baseline|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487702|NCT00390780|P2|Participant Flow|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day, for 14 days
487703|NCT00390780|P1|Participant Flow|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487704|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487705|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487706|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487707|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487708|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487709|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487710|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487711|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487712|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487713|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487714|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487715|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487716|NCT00390780|O2|Outcome|Clotrimazole Troches|Clotrimazole troches, 10 mg, 5 times per day for 14 days
487717|NCT00390780|O1|Outcome|Miconazole Lauriad Buccal Tablet|Miconazole Lauriad 50 mg mucoadhesive buccal tablet, once daily, for 14 days
487733|NCT00390689|B3|Baseline|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487734|NCT00390689|B2|Baseline|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487735|NCT00390689|B1|Baseline|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487736|NCT00390689|P3|Participant Flow|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487737|NCT00390689|P2|Participant Flow|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487738|NCT00390689|P1|Participant Flow|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487739|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487740|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487827|NCT00390559|B1|Baseline|All Participants|In this study, overnight abstinent smokers completed four, double-blind laboratory sessions corresponding to a 2x2 design where transdermal nicotine dose (TN, 0 or 21 mg) was crossed with type of cigarette (nicotine-containing [NIC] or not [DENIC]). Cigarettes were smoked 4 hours after TN administration.
487829|NCT00390559|O4|Outcome|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
488867|NCT00386334|O1|Outcome|Placebo|Placebo tablets
487741|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487742|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487743|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487744|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487745|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487746|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487747|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487748|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487749|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487750|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487751|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487830|NCT00390559|O3|Outcome|Active P/PlaceboC|21 mg patch/no nicotine cigarette
487752|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487753|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487754|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487755|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487756|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487757|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487758|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487759|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487760|NCT00390689|O3|Outcome|Pramipexole 0.50mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487761|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487762|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487831|NCT00390559|O2|Outcome|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
487763|NCT00390689|O4|Outcome|Pramipexole 0.75mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487764|NCT00390689|O3|Outcome|Pramipexole 0.5mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487765|NCT00390689|O2|Outcome|Pramipexole 0.25mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487766|NCT00390689|O1|Outcome|Pramipexole 0.125mg Group|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487767|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487768|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487769|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487770|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487771|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487832|NCT00390559|O1|Outcome|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
487833|NCT00390559|E4|Reported Event|PlaceboP/PlaceboC|0 mg patch/no nicotine cigarette
487772|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487773|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487774|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487775|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487776|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487777|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487778|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487779|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487780|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487781|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487782|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487783|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487784|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487785|NCT00390689|O3|Outcome|Pramipexole 0.75mg Group|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487786|NCT00390689|O2|Outcome|Pramipexole 0.5mg Group|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487787|NCT00390689|O1|Outcome|Pramipexole 0.25mg Group|"Double-blind period: 0.25 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily~Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487788|NCT00390689|E7|Reported Event|Pramipexole 0.75mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.75 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487789|NCT00390689|E6|Reported Event|Pramipexole 0.50mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.5 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487790|NCT00390689|E5|Reported Event|Pramipexole 0.25mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.25 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487791|NCT00390689|E4|Reported Event|Pramipexole 0.125mg (Open Label)|"Open-label period:~Administration of pramipexole was started at 0.25 mg/day at Week 6 (Visit 5, the last observation day in the double-blind period). Subsequently, the Patient Global Impression (PGI) and tolerability was assessed from Visit 6 and if required, the investigator or subinvestigator determined whether to increase the daily dose to 0.5 mg and then to 0.75 mg/day every two weeks. After checking the PGI and tolerability at each visit, the investigator or sub-investigator determined dose increase, maintenance or reduction.~The end-of-trial dosage was 0.125 mg. mode of administration.: Oral, once daily, 2-3 hours before bedtime"
487792|NCT00390689|E3|Reported Event|Pramipexole 0.75mg (Double-blind)|"Double-blind period: 0.75 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 6 tablets of 0.125mg Pramipexole once daily"
487793|NCT00390689|E2|Reported Event|Pramipexole 0.50mg (Double-blind)|"Double-blind period: 0.5 mg randomised group~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 4 tablets of 0.125mg Pramipexole once daily Week 4-6: 4 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily"
487794|NCT00390689|E1|Reported Event|Pramipexole 0.25mg (Double-blind)|"Double-blind period: 0.25 mg randomised group.~Administration as follows:~Week 1: 1 tablet of 0.125mg Pramipexole once daily Week 2: 2 tablets of 0.125mg Pramipexole once daily Week 3: 2 tablets of 0.125mg Pramipexole + 2 tablets of the matching placebo once daily Week 4-6: 2 tablets of 0.125mg Pramipexole + 4 tablets of the matching placebo once daily"
487795|NCT00390611|B3|Baseline|Total|Total of all reporting groups
487796|NCT00390611|B2|Baseline|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487797|NCT00390611|B1|Baseline|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487798|NCT00390611|P2|Participant Flow|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
487799|NCT00390611|P1|Participant Flow|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
487800|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
487801|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
487802|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
487803|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
487804|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV
487805|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid
487806|NCT00390611|O2|Outcome|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487807|NCT00390611|O1|Outcome|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487808|NCT00390611|E2|Reported Event|Paclitaxel/Carboplatin|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487809|NCT00390611|E1|Reported Event|Paclitaxel/Carboplatin/Sorafenib|"Paclitaxel 175 mg/m2 1-3 hour IV infusion, Day 1 Carboplatin AUC 6 infused over 20 minutes IV, Day 1 Sorafenib 400mg PO bid~Sorafenib~Paclitaxel: Paclitaxel~Carboplatin: Carboplatin"
487810|NCT00390572|B3|Baseline|Total|Total of all reporting groups
487811|NCT00390572|B2|Baseline|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487834|NCT00390559|E3|Reported Event|Active P/PlaceboC|21 mg patch/no nicotine cigarette
487835|NCT00390559|E2|Reported Event|PlaceboP/ActiveC|0 mg patch/nicotine-containing cigarette
487836|NCT00390559|E1|Reported Event|ActiveP/ActiveC|21 mg patch/Nicotine-containing cigarette
487812|NCT00390572|B1|Baseline|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487813|NCT00390572|P2|Participant Flow|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487814|NCT00390572|P1|Participant Flow|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants' primary care providers."
487815|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487816|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487817|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487818|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487819|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487820|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487821|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487822|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487823|NCT00390572|O2|Outcome|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487824|NCT00390572|O1|Outcome|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487825|NCT00390572|E2|Reported Event|Treatment as Usual|Participants randomized to receive a one-time sleep consultation after completing study procedures (after 10 month study wait-list period).
487826|NCT00390572|E1|Reported Event|Sleep Specialty Consultation|"Participants randomized to receive a one-time sleep consultation at beginning of study~Sleep Specialty Consultation: The Sleep Specialty Consultation (SSC) consisted of: (1) a thorough sleep disorders evaluation accomplished via a clinician-administered structured interview designed to assess specific symptoms of global sleep disorder categories, review of a sleep history questionnaire, and review of available (CPRS) medical/psychiatric electronic records; (2) education about the specific sleep disorders diagnoses and relevant treatment recommendations provided to the patients; and (3) standardized diagnostic information and treatment recommendations provided to the participants� primary care providers."
487837|NCT00390546|B3|Baseline|Total|Total of all reporting groups
487838|NCT00390546|B2|Baseline|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
487839|NCT00390546|B1|Baseline|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
487840|NCT00390546|P2|Participant Flow|Propranolol|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the drug was administered orally at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
487841|NCT00390546|P1|Participant Flow|Digoxin|The study drug was given for 6 months or until one of the study end points was reached. To account for differences in pharmacokinetics, the first 2 doses of digoxin were administered oraly at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
487842|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
487843|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
487844|NCT00390546|O2|Outcome|Propranolol|Single dose administered orally at 0.5/kg per dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
487845|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
487846|NCT00390546|O2|Outcome|Propranolol|Single dose administered at 0.5 mg/kg per dose as a single dose and increased to 1.0 mg/kg per dose TID for the second and subsequent doses.
487847|NCT00390546|O1|Outcome|Digoxin|The first 2 doses of digoxin were administered orally at 0.010 mg/kg per dose TID, then 0.0035 mg/kg per dose TID for the third and subsequent doses.
487848|NCT00390546|E2|Reported Event|Propranolol|
487849|NCT00390546|E1|Reported Event|Digoxin|
487850|NCT00390468|B1|Baseline|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
487851|NCT00390468|P1|Participant Flow|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
487852|NCT00390468|O1|Outcome|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
487853|NCT00390468|E1|Reported Event|Tandutinib (MLN518)|500 mg twice daily, a small-molecule inhibitor of the type III receptor tyrosine kinases
487854|NCT00390455|B3|Baseline|Total|Total of all reporting groups
487855|NCT00390455|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487856|NCT00390455|B1|Baseline|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487857|NCT00390455|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487858|NCT00390455|P1|Participant Flow|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487859|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487860|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487861|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487862|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487863|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487864|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487865|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487866|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487867|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487868|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487869|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487870|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487871|NCT00390455|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487872|NCT00390455|O1|Outcome|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487873|NCT00390455|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg) of each subsequent course.
487874|NCT00390455|E1|Reported Event|Arm I (Lapatinib)|Patients receive 1500 mg lapatinib ditosylate PO QD on days 1-28 and fulvestrant IM on days 1 (500 mg) and 15 (250 mg) of course 1 and on day 1 (250 mg)of each subsequent course.
487875|NCT00390416|B1|Baseline|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
487876|NCT00390416|P1|Participant Flow|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|"Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin~Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin: Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes"
487877|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
487878|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
487879|NCT00390416|O1|Outcome|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
487880|NCT00390416|E1|Reported Event|Docetaxel, Cisplatin, Fluorouracil, Bevacizumab, Leucovorin|Bevacizumab 10mg/kg day 1 IV over 30 minutes Docetaxel 40mg/m2 day 1 IV over 1 hour Leucovorin 400mg/m2 day 1 IV over 30 minutes Fluorouracil 400mg/m2 IVP day 1 Fluorouracil 1000mg/m2 IVCI x 48 hours Cisplatin 40mg/m2 day 3 IV over 30 minutes
487881|NCT00390364|B1|Baseline|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
487882|NCT00390364|P1|Participant Flow|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
487883|NCT00390364|O1|Outcome|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
487884|NCT00390364|E1|Reported Event|RAD0001|Eligible patients will be treated with single agent RAD 001 at doses on 10 mg per day orally. Tumor samples will be obtained before and after treatment by means of fine needle aspirate (FNA)-guided tumor biopsies. Treatment effects will be determined by serial MRI scans. Patients will continue treatment until tumor progression or intolerable toxicity.
487885|NCT00390234|B1|Baseline|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
487886|NCT00390234|P1|Participant Flow|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
487887|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
487888|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
487889|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
487890|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV"
487891|NCT00390234|O1|Outcome|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
487892|NCT00390234|E1|Reported Event|Treatment (Ziv-aflibercept)|"Patients receive ziv-aflibercept IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~ziv-aflibercept: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
487893|NCT00390221|B4|Baseline|Total|Total of all reporting groups
487894|NCT00390221|B3|Baseline|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487895|NCT00390221|B2|Baseline|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487896|NCT00390221|B1|Baseline|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487897|NCT00390221|P3|Participant Flow|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487898|NCT00390221|P2|Participant Flow|150 mg DAC HYP|150 mg Daclizumab High Yield Process (DAC HYP) administered as 3 SC injections every 4 weeks for up to 52 weeks
488183|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
487900|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487901|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487902|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487903|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487904|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487905|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487906|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487907|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487908|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487909|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487910|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487911|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487912|NCT00390221|O3|Outcome|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487913|NCT00390221|O2|Outcome|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487914|NCT00390221|O1|Outcome|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487915|NCT00390221|E4|Reported Event|Total Active|150 mg or 300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487916|NCT00390221|E3|Reported Event|300 mg DAC HYP|300 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487917|NCT00390221|E2|Reported Event|150 mg DAC HYP|150 mg DAC HYP administered as 3 SC injections every 4 weeks for up to 52 weeks
487918|NCT00390221|E1|Reported Event|Placebo|Placebo administered as 3 SC injections every 4 weeks for up to 52 weeks
487919|NCT00390182|B1|Baseline|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
487920|NCT00390182|P1|Participant Flow|Gem(1250mg/m2, d1, 8) +LDFRT (60cGy/fx BID, d1,2,8,9)|4 cycles (1 cycle = 21 days): Gemcitabine 1250/m2 given IV Day 1 and Day 8; with concurrent Low Dose Fractionated Radiation Therapy (LDFRT). The total Radiation dose would be 19.2 Gy divided over 32 fractions. Treatment will be given in 2 fractions with a minimum 4 hr inter-fraction interval, not to exceed 6 hours. Radiotherapy given after the initiation of Gemcitabine Days 1,2,8, and 9.
487921|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
487922|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
487923|NCT00390182|O1|Outcome|Low Dose Fractionated Radiation Therapy (LDFRT) + Gemcitabine|Use of LDFRT with systemic gemcitabine is safe, tolerable, and potentially effective. In advanced pancreatic cancer, where response rates with single agent gemcitabine have been low, this chemopotentiation paradigm may improve survival among a poor prognostic patient cohort.
487924|NCT00390182|E1|Reported Event|Standard Chemotherapy, Gemcitabine With Concurrent Low Dose Ra|
487925|NCT00389974|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
487926|NCT00389974|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
487927|NCT00389974|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
487928|NCT00389974|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO daily for 4 weeks. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR may receive 2 courses after CR or PR is reached.~sunitinib malate: Given PO"
487929|NCT00389857|B3|Baseline|Total|Total of all reporting groups
487930|NCT00389857|B2|Baseline|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
487931|NCT00389857|B1|Baseline|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
487932|NCT00389857|P2|Participant Flow|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
487933|NCT00389857|P1|Participant Flow|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
487934|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
487935|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
487936|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
487937|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
487938|NCT00389857|O2|Outcome|Influenza Vaccine-Primed Group|Subjects have received Influenza virus vaccine in the past
487939|NCT00389857|O1|Outcome|Influenza Vaccine-Naive Group|Subjects have never received Influenza virus vaccine
487940|NCT00389857|E2|Reported Event|Influenza Vaccine-Primed Group|Participants have received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0.
487941|NCT00389857|E1|Reported Event|Influenza Vaccine-Naive Group|Participants have never received Influenza virus vaccine in the past. They received a single dose of Fluzone® vaccine on Day 0 and Day 28, respectively.
487942|NCT00389831|B3|Baseline|Total|Total of all reporting groups
487943|NCT00389831|B2|Baseline|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
487944|NCT00389831|B1|Baseline|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
487945|NCT00389831|P2|Participant Flow|Rotigotine Nasal Spray|Subjects receiving doses of placebo nasal spray on Day 1 or Day 2, Rotigotine nasal spray 62µg on Day 1 or Day 2, Rotigotine nasal spray 124µg on Day 3, and Rotigotine nasal spray 247µg on Day 4
487946|NCT00389831|P1|Participant Flow|Placebo|Subjects receiving a single dose of placebo nasal spray on all 4 treatment days
487947|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
487948|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
487949|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
487950|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
487951|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
487952|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
487953|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
487954|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
487955|NCT00389831|O8|Outcome|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
487956|NCT00389831|O7|Outcome|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
487957|NCT00389831|O6|Outcome|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
487958|NCT00389831|O5|Outcome|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
487959|NCT00389831|O4|Outcome|Placebo - Day 4|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 4.
487960|NCT00389831|O3|Outcome|Placebo - Day 3|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 3.
487961|NCT00389831|O2|Outcome|Placebo - Day 2|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 2.
487962|NCT00389831|O1|Outcome|Placebo - Day 1|Subjects randomized to placebo treatment arm receiving a single dose of placebo nasal spray on Day 1.
487963|NCT00389831|E8|Reported Event|Rotigotine Nasal Spray - Rotigotine 247µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 247µg nasal spray on Day 4.
487964|NCT00389831|E7|Reported Event|Rotigotine Nasal Spray - Rotigotine 124µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 124µg nasal spray on Day 3.
487965|NCT00389831|E6|Reported Event|Rotigotine Nasal Spray - Rotigotine 62µg|Subjects randomized to rotigotine nasal spray arm receiving a single dose of rotigotine 62µg nasal spray on Day 1 or Day 2.
487966|NCT00389831|E5|Reported Event|Rotigotine Nasal Spray - Placebo|Subjects randomized to rotigotine nasal spray arm receiving a single dose of placebo nasal spray on Day 1 or Day 2.
487967|NCT00389831|E4|Reported Event|Placebo - Day 4|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 4.
487968|NCT00389831|E3|Reported Event|Placebo - Day 3|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 3.
487969|NCT00389831|E2|Reported Event|Placebo - Day 2|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 2.
487970|NCT00389831|E1|Reported Event|Placebo - Day 1|Subjects randomized to placebo treatment group, receiving a single dose of placebo nasal spray on Day 1.
487971|NCT00389818|B1|Baseline|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
487972|NCT00389818|P1|Participant Flow|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
487973|NCT00389818|O1|Outcome|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
487974|NCT00389818|E1|Reported Event|DR-COP|Single arm interventional study: all subjects receive Doxil, Rituximab, Cyclophosphamide, Vincristine and Prednisone (DR-COP) regimen.
487975|NCT00389597|B5|Baseline|Total|Total of all reporting groups
487976|NCT00389597|B4|Baseline|2 Level ACDF|
487977|NCT00389597|B3|Baseline|2 Level TDR|
487978|NCT00389597|B2|Baseline|1 Level ACDF|
487979|NCT00389597|B1|Baseline|1 Level TDR|
487980|NCT00389597|P4|Participant Flow|2 Level ACDF Arm|2 level control procedure (ACDF)
487981|NCT00389597|P3|Participant Flow|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
487982|NCT00389597|P2|Participant Flow|1 Level ACDF Arm|1 level control procedure (ACDF)
488231|NCT00389064|B1|Baseline|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
487983|NCT00389597|P1|Participant Flow|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
487984|NCT00389597|O4|Outcome|2 Level TDR|control procedure (ACDF) at two levels
487985|NCT00389597|O3|Outcome|2 Level ACDF|Cervical artificial disc (investigational device) at 2 levels compared with control procedure (ACDF) at two levels
487986|NCT00389597|O2|Outcome|1 Level TDR|Cervical artificial disc (investigational device) at 1 level
487987|NCT00389597|O1|Outcome|1 Level ACDF|control procedure (ACDF) at one level
487988|NCT00389597|E4|Reported Event|2 Level ACDF Arm|
487989|NCT00389597|E3|Reported Event|2 Level TDR Arm|Cervical artificial disc (investigational device) at 2 levels
487990|NCT00389597|E2|Reported Event|1 Level ACDF Arm|
487991|NCT00389597|E1|Reported Event|1 Level TDR Arm|Cervical artificial disc (investigational device) at 1 level
487992|NCT00389532|B3|Baseline|Total|Total of all reporting groups
487993|NCT00389532|B2|Baseline|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
487994|NCT00389532|B1|Baseline|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
487995|NCT00389532|P2|Participant Flow|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
487996|NCT00389532|P1|Participant Flow|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
487997|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
487998|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
487999|NCT00389532|O2|Outcome|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
488000|NCT00389532|O1|Outcome|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
488001|NCT00389532|E2|Reported Event|Aged ≥ 60 Years|Participants aged 60 years and older at enrollment
488002|NCT00389532|E1|Reported Event|Aged 18 to 59 Years|Participants aged 18 to 59 years at enrollment
488003|NCT00389519|B5|Baseline|Total|Total of all reporting groups
488004|NCT00389519|B4|Baseline|Ramipril High Dose|
488005|NCT00389519|B3|Baseline|Ramipril Mid Dose|
488006|NCT00389519|B2|Baseline|Ramipril Low Dose|
488007|NCT00389519|B1|Baseline|Placebo|
488008|NCT00389519|P4|Participant Flow|Ramipril High Dose|
488009|NCT00389519|P3|Participant Flow|Ramipril Mid Dose|
488010|NCT00389519|P2|Participant Flow|Ramipril Low Dose|
488011|NCT00389519|P1|Participant Flow|Placebo|
488012|NCT00389519|O4|Outcome|Ramipril High Dose|
488013|NCT00389519|O3|Outcome|Ramipril Mid Dose|
488014|NCT00389519|O2|Outcome|Ramipril Low Dose|
488015|NCT00389519|O1|Outcome|Placebo|
488016|NCT00389519|O4|Outcome|Ramipril High Dose|
488017|NCT00389519|O3|Outcome|Ramipril Mid Dose|
488018|NCT00389519|O2|Outcome|Ramipril Low Dose|
488019|NCT00389519|O1|Outcome|Placebo|
488020|NCT00389519|O4|Outcome|Ramipril High Dose|
488021|NCT00389519|O3|Outcome|Ramipril Mid Dose|
488022|NCT00389519|O2|Outcome|Ramipril Low Dose|
488023|NCT00389519|O1|Outcome|Placebo|
488024|NCT00389519|O4|Outcome|Ramipril High Dose|
488025|NCT00389519|O3|Outcome|Ramipril Mid Dose|
488026|NCT00389519|O2|Outcome|Ramipril Low Dose|
488027|NCT00389519|O1|Outcome|Placebo|
488028|NCT00389519|O4|Outcome|Ramipril High Dose|
488029|NCT00389519|O3|Outcome|Ramipril Mid Dose|
488030|NCT00389519|O2|Outcome|Ramipril Low Dose|
488031|NCT00389519|O1|Outcome|Placebo|
488032|NCT00389519|E4|Reported Event|Ramipril High Dose|
488033|NCT00389519|E3|Reported Event|Ramipril Mid Dose|
488034|NCT00389519|E2|Reported Event|Ramipril Low Dose|
488035|NCT00389519|E1|Reported Event|Placebo|
488036|NCT00389493|B4|Baseline|Total|Total of all reporting groups
488037|NCT00389493|B3|Baseline|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
488038|NCT00389493|B2|Baseline|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
488039|NCT00389493|B1|Baseline|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
488040|NCT00389493|P3|Participant Flow|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
488041|NCT00389493|P2|Participant Flow|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
488042|NCT00389493|P1|Participant Flow|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
488043|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
488044|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
488045|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
488046|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants will receive treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone."
488047|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants will receive exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response."
488048|NCT00389493|O1|Outcome|Treatment With Risperidone|"Participants will receive treatment with risperidone~Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated"
488049|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
488050|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
488051|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
488052|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
488053|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
488054|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
488055|NCT00389493|O3|Outcome|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
488056|NCT00389493|O2|Outcome|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
488057|NCT00389493|O1|Outcome|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
488058|NCT00389493|E3|Reported Event|Treatment With Pill Placebo|"Participants received treatment with the placebo~Placebo : Placebo capsules will be identical in appearance to those of risperidone.~Mean Y-BOCS score measured at week 8"
488059|NCT00389493|E2|Reported Event|Treatment With Exposure/Response Prevention|"Participants received exposure and response prevention therapy~Exposure/ritual prevention therapy (EX/RP) : EX/RP is a form of cognitive behavioral therapy. Participants assigned to EX/RP will attend therapy sessions twice per week. In EX/RP, participants will be exposed to feared objects or ideas, and will be encouraged not to carry out a compulsive response.~Mean Y-BOCS score measured at week 8"
488060|NCT00389493|E1|Reported Event|Treatment With Risperidone|Participants received treatment with risperidone Risperidone : Dosage of 0.5 mg to 4.0 mg per day as tolerated Mean Y-BOCS score measured at week 8
488061|NCT00389467|B5|Baseline|Total|Total of all reporting groups
488062|NCT00389467|B4|Baseline|Standard Care, Nonpenumbral|Treatment assignment = standard medical care, imaging pattern = nonpenumbral
488063|NCT00389467|B3|Baseline|Embolectomy, Nonpenumbral|Treatment assignment = embolectomy, imaging pattern = nonpenumbral
488064|NCT00389467|B2|Baseline|Standard Care, Penumbral|Treatment assignment = standard medical care, imaging pattern = penumbral
488065|NCT00389467|B1|Baseline|Embolectomy, Penumbral|Treatment assignment = embolectomy, imaging pattern = penumbral
488066|NCT00389467|P4|Participant Flow|Standard Care, Nonpenumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
488067|NCT00389467|P3|Participant Flow|Embolectomy, Nonpenumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
488068|NCT00389467|P2|Participant Flow|Standard Care, Penumbral|"Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
488069|NCT00389467|P1|Participant Flow|Embolectomy, Penumbral|"Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.~Intra-arterial tPA up to 14 milligrams was allowed as rescue therapy within 6 hours of onset."
488070|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488071|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488072|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488073|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488074|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488075|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488076|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488077|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488078|NCT00389467|O4|Outcome|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488079|NCT00389467|O3|Outcome|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488080|NCT00389467|O2|Outcome|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488081|NCT00389467|O1|Outcome|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488082|NCT00389467|E5|Reported Event|Standard Care, Nonpenumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488083|NCT00389467|E4|Reported Event|Embolectomy, Nonpenumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A nonpenumbral pattern was defined as a predicted infarct core of greater than 90 ml or a proportion of predicted infarct tissue within the at-risk region of greater than 70%.
488084|NCT00389467|E3|Reported Event|Standard Care, Penumbral|Standard medical care was recommended per the AHA (American Heart Association)/ASA (American Stroke Association) Guidelines for management of acute ischemic stroke. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488085|NCT00389467|E2|Reported Event|Embolectomy, Penumbral|Embolectomy patients were treated up to 8 hours from symptom onset with any combination of FDA-cleared embolectomy devices, including the Merci Retriever since trial initiation in 2004 and Penumbra System since 2009. A favorable penumbral pattern was defined as a predicted infarct core of 90 ml or less and a proportion of predicted infarct tissue within the at-risk region of 70% or less.
488086|NCT00389467|E1|Reported Event|Total Cohort|
488087|NCT00389441|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488088|NCT00389441|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488089|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488232|NCT00389064|P2|Participant Flow|Placebo|
488090|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488091|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488092|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488093|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488094|NCT00389441|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488095|NCT00389441|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily continuously in 28-day cycles until tumor progression, unmanageable toxicity, or withdrawal of consent occurred. Dose was increased (to 7 mg or 10 mg twice daily) or decreased (to 3 mg or 2 mg twice daily) based on the tolerability.
488096|NCT00389324|B1|Baseline|Safety Population|The safety population included all subjects who received any amount of study medication (IGIV-C) via intravenous (IV) and/or subcutaneous (SC) routes of administration. As such, the safety population included all study participants combined (who received any dose), whether they entered the study in the Run-In or Intravenous Phase.
488097|NCT00389324|P1|Participant Flow|IGIV-C|"21 subjects were required to enter a Run-In Phase (3 to 4 months) and received IGIV-C between 200 and 600 mg/kg by intravenous infusion every 3 or 4 weeks. 18 subjects completed the Run-In Phase and entered the Intravenous Phase.~A total of 32 subjects entered the IV Phase: 14 subjects who had received IV IGIV-C prior to screening directly entered the IV Phase and 18 subjects who had completed the Run-in Phase continued in the study to enter the IV Phase. Subjects in the IV Phase received two IV infusions at the same dose (200-600 mg/kg) and frequency (every 3 or 4 weeks) as their regular dose at screening or during the Run-In Phase. All 32 subjects completed the IV Phase and entered the SC Phase.~A total of 32 subjects who completed the IV Phase entered the SC Phase. Subjects in the SC Phase received IGIV-C via weekly SC administration for 24 weeks total at a dose that was calculated using a conversion factor and their established IV dose. 25 subjects completed the SC Phase."
488098|NCT00389324|O2|Outcome|Gamunex Subcutaneous (SC) Administration|Subjects who received Gamunex via SC administration.
488099|NCT00389324|O1|Outcome|Gamunex Intravenous (IV) Administration|Subjects who received Gamunex via IV administration.
488100|NCT00389324|E3|Reported Event|Subcutaneous Phase|All subjects who participated in the Subcutaneous Phase.
488101|NCT00389324|E2|Reported Event|Intravenous Phase|All subjects who participated in the Intravenous Phase.
488102|NCT00389324|E1|Reported Event|Run-In Phase|All subjects who participated in the Run-In Phase.
488103|NCT00389207|B4|Baseline|Total|Total of all reporting groups
488104|NCT00389207|B3|Baseline|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488105|NCT00389207|B2|Baseline|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488106|NCT00389207|B1|Baseline|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488107|NCT00389207|P3|Participant Flow|Atazanvir/Ritonavir|Atazanvir 300mg QD boosted by ritonavir 100mg QD (ATZ/r) on a background of the fixed combination Truvada®
488108|NCT00389207|P2|Participant Flow|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488109|NCT00389207|P1|Participant Flow|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488110|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488111|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488112|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488113|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488114|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488115|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488116|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488117|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488118|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488119|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488120|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488121|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488122|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488123|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488124|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488125|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488126|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488127|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488128|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488129|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488130|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488131|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488132|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488133|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488134|NCT00389207|O3|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488135|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488136|NCT00389207|O1|Outcome|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488137|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488138|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488139|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488140|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488141|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488142|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488143|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488144|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488145|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488146|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488147|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488148|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488149|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488150|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488151|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488152|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488153|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488154|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488155|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488156|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488157|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488158|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488159|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488160|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488161|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488162|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488163|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488164|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488165|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488166|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488167|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488168|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488169|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488170|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488171|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488172|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488173|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488174|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488175|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488176|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488177|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488178|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488179|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488180|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488181|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488182|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488184|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488185|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488186|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488187|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488188|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488189|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488190|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488191|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488192|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488193|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488194|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488195|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488196|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488197|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488198|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488199|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488200|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488201|NCT00389207|O2|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488202|NCT00389207|O1|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488203|NCT00389207|O4|Outcome|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488204|NCT00389207|O3|Outcome|Nevirapine QD+BID|NVP 400mg QD or 200mg BID on a background of the fixed combination Truvada®
488205|NCT00389207|O2|Outcome|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488206|NCT00389207|O1|Outcome|Nevirapine QD|Nevirapine (NVP) 400mg QD on a background of the fixed combination Truvada® (emitricitabine 200mg QD and tenofovir 300mg QD)
488207|NCT00389207|E3|Reported Event|Atazanvir/Ritonavir|ATZ/r on a background of the fixed combination Truvada®
488208|NCT00389207|E2|Reported Event|Nevirapine BID|NVP 200mg BID on a background of the fixed combination Truvada®
488209|NCT00389207|E1|Reported Event|Nevirapine QD|NVP 400mg QD on a background of the fixed combination Truvada®
488210|NCT00389168|B3|Baseline|Total|Total of all reporting groups
488211|NCT00389168|B2|Baseline|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488212|NCT00389168|B1|Baseline|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488213|NCT00389168|P2|Participant Flow|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
488214|NCT00389168|P1|Participant Flow|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of hydrochlorothiazide (HCTZ) and felodipine when needed to achieve < 140/90 mm Hg
488215|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488216|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488217|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488218|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488219|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488220|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488221|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488222|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488223|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488224|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488225|NCT00389168|O2|Outcome|Irbesartan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488226|NCT00389168|O1|Outcome|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488227|NCT00389168|E2|Reported Event|Atenolol|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488228|NCT00389168|E1|Reported Event|Irbesratan|A double blind study with parallel group treatment with irbesartan or atenolol; addition of HCTZ and felodipine when needed to achieve < 140/90 mm Hg
488229|NCT00389064|B3|Baseline|Total|Total of all reporting groups
488230|NCT00389064|B2|Baseline|Placebo|
488235|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488236|NCT00389064|O2|Outcome|Placebo|
488237|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488238|NCT00389064|O2|Outcome|Placebo|
488239|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488240|NCT00389064|O2|Outcome|Placebo|
488241|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488242|NCT00389064|O2|Outcome|Placebo|
488243|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488244|NCT00389064|O2|Outcome|Placebo|
488245|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488246|NCT00389064|O2|Outcome|Placebo|
488247|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488248|NCT00389064|O2|Outcome|Placebo|
488249|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488250|NCT00389064|O2|Outcome|Placebo|
488251|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488252|NCT00389064|O2|Outcome|Placebo|
488253|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488254|NCT00389064|O2|Outcome|Placebo|
488255|NCT00389064|O1|Outcome|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488256|NCT00389064|E2|Reported Event|Placebo|
488257|NCT00389064|E1|Reported Event|Quetiapine XR|Quetiapine fumerate XR - flexibly dosed (50 - 300 mg)
488258|NCT00388973|B3|Baseline|Total|Total of all reporting groups
488259|NCT00388973|B2|Baseline|Placebo|Placebo
488260|NCT00388973|B1|Baseline|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488261|NCT00388973|P2|Participant Flow|Placebo|Placebo
488262|NCT00388973|P1|Participant Flow|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488263|NCT00388973|O2|Outcome|Placebo|Placebo
488264|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488265|NCT00388973|O2|Outcome|Placebo|Placebo
488266|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488267|NCT00388973|O2|Outcome|Placebo|Placebo
488268|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488269|NCT00388973|O2|Outcome|Placebo|Placebo
488270|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488271|NCT00388973|O2|Outcome|Placebo|Placebo
488272|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488273|NCT00388973|O2|Outcome|Placebo|Placebo
488274|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488275|NCT00388973|O2|Outcome|Placebo|Placebo
488276|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488277|NCT00388973|O2|Outcome|Placebo|Placebo
488278|NCT00388973|O1|Outcome|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488279|NCT00388973|E2|Reported Event|Placebo|Placebo
488280|NCT00388973|E1|Reported Event|Quetiapine XR|Quetiapine fumarate XR - flexibly dosed (50 - 300 mg)
488281|NCT00388947|B1|Baseline|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
488282|NCT00388947|P1|Participant Flow|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
488283|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
488284|NCT00388947|O1|Outcome|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
488285|NCT00388947|E1|Reported Event|1 - Any AMS Prolapse Product|at least one AMS prolapse product was used
488286|NCT00388804|B3|Baseline|Total|Total of all reporting groups
488287|NCT00388804|B2|Baseline|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
488288|NCT00388804|B1|Baseline|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
488289|NCT00388804|P2|Participant Flow|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
488290|NCT00388804|P1|Participant Flow|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
488291|NCT00388804|O2|Outcome|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
488292|NCT00388804|O1|Outcome|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
488293|NCT00388804|E2|Reported Event|RT Group 2 + Hormone Therapy|Radiation Therapy over 8 1/2 weeks; + Hormone Therapy (Bicalutamide 50 mg orally/day or Flutamide 250 mg orally 3 times daily on first 21-30 Days) + Leuprolide (22.5 mg Intramuscularly (IM)/every 3 months or 7.5 mg IM monthly) or Goserelin (10.8 mg subcutaneously every 3 months or 3.6 mg subcutaneously monthly)
488294|NCT00388804|E1|Reported Event|RT Group 1|Radiation Therapy (RT) over 8 1/2 weeks: 42 treatments, 5 days per week with 2 days rest in between.
488295|NCT00388037|B1|Baseline|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
488759|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488296|NCT00388037|P1|Participant Flow|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
488297|NCT00388037|O1|Outcome|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
488298|NCT00388037|E1|Reported Event|Treatment (Sunitinib Malate)|"Patients receive sunitinib malate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sunitinib malate: Given PO~laboratory biomarker analysis: Correlative studies"
488299|NCT00387153|B1|Baseline|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
488300|NCT00387153|P1|Participant Flow|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
488301|NCT00387153|O1|Outcome|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
488302|NCT00387153|E1|Reported Event|MPC-2130 Group 1|Group 1 will be dosed at 10 mg/ml administered via IV over a 1-2 hour period.
488303|NCT00388726|B3|Baseline|Total|Total of all reporting groups
488304|NCT00388726|B2|Baseline|Treatment of Physician's Choice|Treatment of Physician's Choice
488305|NCT00388726|B1|Baseline|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488306|NCT00388726|P2|Participant Flow|Treatment of Physician's Choice|Treatment of Physician's Choice
488307|NCT00388726|P1|Participant Flow|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488308|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
488309|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488310|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
488311|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488312|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
488313|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488314|NCT00388726|O2|Outcome|Treatment of Physician's Choice|Treatment of Physician's Choice
488315|NCT00388726|O1|Outcome|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488316|NCT00388726|E2|Reported Event|Treatment of Physician's Choice|Treatment of Physician's Choice
488317|NCT00388726|E1|Reported Event|Eribulin Mesylate 1.4 mg/kg^2|Eribulin Mesylate 1.4 mg/kg^2 on Days 1 and 8
488318|NCT00388583|B3|Baseline|Total|Total of all reporting groups
488319|NCT00388583|B2|Baseline|Fluzone IM Vaccine Group|Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
488320|NCT00388583|B1|Baseline|Fluzone ID Vaccine Group|Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
488321|NCT00388583|P2|Participant Flow|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488322|NCT00388583|P1|Participant Flow|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488323|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488324|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488325|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488326|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488327|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488328|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488329|NCT00388583|O2|Outcome|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488330|NCT00388583|O1|Outcome|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488331|NCT00388583|E2|Reported Event|Fluzone Intramuscular (IM) Vaccine Group|Participants received a dose of Fluzone Intramuscular vaccine on Day 0
488332|NCT00388583|E1|Reported Event|Fluzone Intradermal (ID) Vaccine Group|Participants received a dose of Fluzone Intradermal vaccine on Day 0
488333|NCT00388505|B3|Baseline|Total|Total of all reporting groups
488334|NCT00388505|B2|Baseline|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488335|NCT00388505|B1|Baseline|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488336|NCT00388505|P2|Participant Flow|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488337|NCT00388505|P1|Participant Flow|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488338|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488339|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488760|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488340|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488341|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488342|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488343|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488344|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488345|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488346|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488347|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488348|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488349|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488350|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488351|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488352|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488353|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488354|NCT00388505|O2|Outcome|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488355|NCT00388505|O1|Outcome|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488356|NCT00388505|E2|Reported Event|Tobramycin Solution for Inhalation (TOBI)|Participants received one 300 mg (in 5 mL) ampoule of tobramycin solution for inhalation (TOBI) delivered with a nebulizer twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488357|NCT00388505|E1|Reported Event|Tobramycin Inhalation Powder (TIP)|Participants received four 28 mg capsules of tobramycin inhalation powder (TIP) delivered with the T-326 inhaler twice daily for 28 days followed by 28 days off therapy (one cycle) for a total of three cycles.
488358|NCT00388154|B1|Baseline|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
488359|NCT00388154|P1|Participant Flow|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
488360|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
488361|NCT00388154|O1|Outcome|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
488362|NCT00388154|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine 900 mg/m^2 and Cisplatin 30 mg/m^2 by vein (IV) over 1 hour on Day 1 and Day 8.
488363|NCT00387959|B1|Baseline|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
488364|NCT00387959|P1|Participant Flow|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
488365|NCT00387959|O1|Outcome|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
488366|NCT00387959|E1|Reported Event|Unrelated Donor Umbilical Cord Transplant|Non-Myeloablative Conditioning Regimen with Peri-Transplant Rituximab and the Transplantation of Unrelated Donor Umbilixal Cord Blood
488367|NCT00387894|B1|Baseline|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
488462|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488368|NCT00387894|P1|Participant Flow|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|Tarceva self-administered in an open-label, unblinded manner to all patients enrolled. During the treatment period, patients who are not receiving enzyme-inducing antiepileptic drugs (EIAED) will receive single-agent Tarceva, 150 mg/day. Patients on EIAED will receive single-agent Tarceva, 600 mg/day. Tablets should be taken at the same time each day with 200 mL of water at least 1 hour before or 2 hours after a meal. Patients who are unable to swallow tablets may dissolve the tablets in distilled water for administration. The dose of Tarceva will be escalated after 14 days from 150 to 200 mg/day or from 600 to 650 mg/day assuming no intolerable grade 2 rash, any grade 3 rash, or grade 2 diarrhea despite loperamide.
488369|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
488370|NCT00387894|O1|Outcome|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
488371|NCT00387894|E1|Reported Event|Oral Erlotinib Hydrochloride (Tarceva) Daily on Days 1-28|erlotinib hydrochloride (Tarceva) self-administered in an open-label, unblinded manner to all patients enrolled in the study.
488372|NCT00387881|B3|Baseline|Total|Total of all reporting groups
488373|NCT00387881|B2|Baseline|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet. Baseline Characteristics used the Safety Population. Not the Randomised Population
488374|NCT00387881|B1|Baseline|Placebo|Baseline Characteristics used the Safety Population. Not the Randomised Population
488375|NCT00387881|P2|Participant Flow|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488376|NCT00387881|P1|Participant Flow|Placebo|
488377|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488378|NCT00387881|O1|Outcome|Placebo|
488379|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488380|NCT00387881|O1|Outcome|Placebo|
488381|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488382|NCT00387881|O1|Outcome|Placebo|
488383|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488384|NCT00387881|O1|Outcome|Placebo|
488385|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488386|NCT00387881|O1|Outcome|Placebo|
488387|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488388|NCT00387881|O1|Outcome|Placebo|
488389|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488390|NCT00387881|O1|Outcome|Placebo|
488391|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488392|NCT00387881|O1|Outcome|Placebo|
488393|NCT00387881|O2|Outcome|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488394|NCT00387881|O1|Outcome|Placebo|
488395|NCT00387881|E2|Reported Event|Sumatriptan/Naproxen|Sumatriptan 85 mg and Naproxen sodium 500mg = Treximet (formerly known as Trexima)
488396|NCT00387881|E1|Reported Event|Placebo|
488397|NCT00387829|B3|Baseline|Total|Total of all reporting groups
488398|NCT00387829|B2|Baseline|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
488399|NCT00387829|B1|Baseline|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
488400|NCT00387829|P2|Participant Flow|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
488401|NCT00387829|P1|Participant Flow|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
488402|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
488403|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
488404|NCT00387829|O2|Outcome|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
488405|NCT00387829|O1|Outcome|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
488406|NCT00387829|E2|Reported Event|2 - Surgery Alone|Control arm is surgery alone (no adhesion barrier)
488407|NCT00387829|E1|Reported Event|1- DuraGen Plus During Surgery|Use of DuraGen Plus Adhesion Barrier Matrix as an adhesion barrier in the spine
488408|NCT00387790|B1|Baseline|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
488409|NCT00387790|P1|Participant Flow|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
488410|NCT00387790|O1|Outcome|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
488595|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488411|NCT00387790|E1|Reported Event|Radiation and Motexafin Gadolinium|"Patients receive motexafin gadolinium IV over 5-10 minutes once daily (prior to radiotherapy) 5 days a week for 6 weeks. Patients undergo localized cranial radiotherapy once daily 5 days a week for 6 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.~motexafin gadolinium: Given IV~2-dimensional, 3-dimensional conformal, or intensity-modulated radiation therapy: Undergo localized cranial radiotherapy"
488412|NCT00387764|B1|Baseline|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488413|NCT00387764|P1|Participant Flow|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488414|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488415|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488416|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488417|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488418|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488419|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488420|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488421|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488422|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488423|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488424|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488425|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488426|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488427|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488428|NCT00387764|O1|Outcome|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488429|NCT00387764|E1|Reported Event|Pazopanib 800 mg|Participants received pazopanib 800 milligrams (mg) once daily.
488430|NCT00387751|B1|Baseline|Bevacizumab and Sorafenib|
488431|NCT00387751|P1|Participant Flow|Bevacizumab and Sorafenib|
488432|NCT00387751|O1|Outcome|Bevacizumab and Sorafenib|"Bevacizumab was administered as a 5 mg/kg intravenous dose every 2 weeks. The dose was based on the patient's actual body weight; the dose recalculated if there was a weight change of >10% from baseline.~Sorafenib was administered as a 200 mg oral dose twice daily, for 5 days every 7 days. Courses will be defined as 28-day treatment periods and will be repeated without interruption until development of progressive disease or development of serious drug related toxicities."
488433|NCT00387751|E1|Reported Event|Bevacizumab and Sorafenib|
488434|NCT00387725|B5|Baseline|Total|Total of all reporting groups
488435|NCT00387725|B4|Baseline|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488436|NCT00387725|B3|Baseline|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488437|NCT00387725|B2|Baseline|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488438|NCT00387725|B1|Baseline|Twinrix|Given on a 0, 1-, 6- month schedule
488439|NCT00387725|P4|Participant Flow|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488440|NCT00387725|P3|Participant Flow|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488441|NCT00387725|P2|Participant Flow|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488442|NCT00387725|P1|Participant Flow|Twinrix|Given on a 0, 1-, 6- month schedule
488443|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488444|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488445|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488446|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
488447|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488448|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488449|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488450|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
488451|NCT00387725|O4|Outcome|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488452|NCT00387725|O3|Outcome|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488453|NCT00387725|O2|Outcome|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488454|NCT00387725|O1|Outcome|Twinrix|Given on a 0, 1-, 6- month schedule
488455|NCT00387725|E4|Reported Event|Initial Formulation rLP2086 200 mcg|Given on a 0, 1-, 6- month schedule
488456|NCT00387725|E3|Reported Event|Initial Formulation rLP2086 60 mcg|Given on a 0, 1-, 6- month schedule
488457|NCT00387725|E2|Reported Event|Initial Formulation rLP2086 20 mcg|Given on a 0, 1-, 6- month schedule
488458|NCT00387725|E1|Reported Event|Twinrix|Given on a 0, 1-, 6- month schedule
488459|NCT00387647|B1|Baseline|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488460|NCT00387647|P1|Participant Flow|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488461|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488632|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
488463|NCT00387647|O1|Outcome|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488464|NCT00387647|E1|Reported Event|Azacitidine Treatment|Azacitidine 50 mg/m^2 subcutaneously daily for 5 days (Monday through Friday) on days 1 through 5, every 28 days for 6-12 cycles. Patients were to be followed for 1 year following completion of study drug treatment.
488465|NCT00387621|B4|Baseline|Total|Total of all reporting groups
488466|NCT00387621|B3|Baseline|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
488467|NCT00387621|B2|Baseline|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
488468|NCT00387621|B1|Baseline|Control Group (Normals)|Healthy volunteers without heart disease
488469|NCT00387621|P2|Participant Flow|Nesiritide First, Then Placebo (Arm B)|In the first intervention period the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
488470|NCT00387621|P1|Participant Flow|Placebo First, Then Nesiritide (Arm A)|In the first intervention period the subjects received subcutaneous placebo given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered. There was a 2 week washout period. In the second intervention period, the subjects received subcutaneous nesiritide given in the abdomen. After a lead in period of 15 minutes, the acute saline load was administered.
488471|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
488472|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
488473|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
488474|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
488475|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
488476|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
488477|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
488478|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
488479|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
488480|NCT00387621|O3|Outcome|Preclinical Diastolic Dysfunction Group (PDD)|Participants with an ejection fraction of > 50% and no heart failure symptoms
488481|NCT00387621|O2|Outcome|Preclinical Systolic Dysfunction Group (PSD)|Participants with ejection fraction <40% and no heart failure symptoms
488482|NCT00387621|O1|Outcome|Control Group (Normals)|Healthy volunteers without heart disease
488483|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488484|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488485|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488486|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488487|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488488|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488489|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488490|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488524|NCT00387335|B1|Baseline|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
488761|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488491|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488492|NCT00387621|O3|Outcome|PDD-Preclinical Diastolic Dysfunction|Participants with an ejection fraction of > 50% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488493|NCT00387621|O2|Outcome|PSD-Preclinical Systolic Dysfunction|Participants with ejection fraction <40% and no heart failure symptoms. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488494|NCT00387621|O1|Outcome|Control|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488495|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) and Nesiritide First, then Placebo (Arm B).
488496|NCT00387621|O1|Outcome|Control Group|Healthy volunteers without heart disease. Prior to initiation of study, subjects drank water and emptied their bladders to reach an equilibrium, then baseline urine samples were collected. After these samples were collected, all subjects were randomized into Placebo First, then Nesiritide (Arm A) or Nesiritide First, then Placebo (Arm B).
488497|NCT00387621|E2|Reported Event|Nesiritide|The first 10 subjects in each group received a dose of 5 ug/kg and the next 10 subjects received a dose of 10 ug/kg. As this was a cross over study, all participants received placebo and nesiritide.
488498|NCT00387621|E1|Reported Event|Placebo|The pharmacy created a placebo subcutaneous injection volume to match the volume of the nesiritide dose. As this was a cross over study, all participants received placebo and nesiritide.
488499|NCT00387426|B1|Baseline|Sunitinib|37.5 mg orally daily for 6-week cycle
488500|NCT00387426|P1|Participant Flow|Sunitinib|37.5 mg orally daily for 6-week cycle
488501|NCT00387426|O1|Outcome|Sunitinib|37.5 mg orally daily for 6-week cycle
488502|NCT00387426|E1|Reported Event|Sunitinib|37.5 mg orally daily for 6-week cycle
488503|NCT00387348|B4|Baseline|Total|Total of all reporting groups
488504|NCT00387348|B3|Baseline|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
488505|NCT00387348|B2|Baseline|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
488506|NCT00387348|B1|Baseline|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
488507|NCT00387348|P3|Participant Flow|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
488508|NCT00387348|P2|Participant Flow|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
488509|NCT00387348|P1|Participant Flow|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks.
488510|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram 10 mg once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
488511|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
488512|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo once daily by mouth for the second 4 weeks
488513|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
488514|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
488515|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
488516|NCT00387348|O3|Outcome|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram f10 mg once daily by mouth or the first 4 weeks and placebo once daily by mouth for the second 4 weeks
488517|NCT00387348|O2|Outcome|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and escitalopram 10 mg once daily by mouth for the second 4 weeks
488518|NCT00387348|O1|Outcome|Placebo-Placebo|Participants in this arm were randomized to receive placebo once daily by mouth for the first 4 weeks and placebo oncedaily by mouth for the second 4 weeks
488519|NCT00387348|E3|Reported Event|Escitalopram-Placebo|Participants in this arm were randomzied to receive escitalopram for the first 4 weeks and placebo for the second 4 weeks
488520|NCT00387348|E2|Reported Event|Placebo-Escitalopram|Participants in this arm were randomized to receive placebo for the first 4 weeks and escitalopram for the second 4 weeks
488521|NCT00387348|E1|Reported Event|Placebo-Placebo|Participants in this arm were randomized to receive placebo for the first 4 weeks and placebo for the second 4 weeks
488522|NCT00387335|B3|Baseline|Total|Total of all reporting groups
488523|NCT00387335|B2|Baseline|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
488525|NCT00387335|P2|Participant Flow|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.ECOG Performance Status 2.
488526|NCT00387335|P1|Participant Flow|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
488527|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488528|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488529|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488530|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488531|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488532|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488533|NCT00387335|O2|Outcome|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488534|NCT00387335|O1|Outcome|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity.
488535|NCT00387335|E2|Reported Event|Sunitinib -- Cohort B|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 2.
488536|NCT00387335|E1|Reported Event|Sunitinib -- Cohort A|Patients receive oral sunitinib malate once daily on days 1-28. Courses repeat every 6 weeks in the absence of disease progression or unacceptable toxicity. ECOG Performance Status 0 -1.
488537|NCT00387127|B3|Baseline|Total|Total of all reporting groups
488538|NCT00387127|B2|Baseline|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488539|NCT00387127|B1|Baseline|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488540|NCT00387127|P2|Participant Flow|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488541|NCT00387127|P1|Participant Flow|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488542|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488543|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488868|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488544|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488545|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488546|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488547|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488548|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488549|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488550|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488551|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488552|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488553|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488554|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488555|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488556|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488557|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488558|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488559|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488560|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488561|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488562|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488563|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488564|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488565|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488566|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488567|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488568|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488569|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488570|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488571|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488572|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488573|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488574|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488575|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488576|NCT00387127|O2|Outcome|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction &lt;2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488577|NCT00387127|O1|Outcome|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction <2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488578|NCT00387127|E2|Reported Event|Chemoradiotherapy + Lapatinib, Followed by Lapatinib|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gy to a total dose of 70 Gy (using 2D or 3D techniques) or 65 Gy (using IMRT) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 mg/m^2 was administered IV on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Lapatinib 1500 mg OD administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, lapatinib 1500 mg OD monotherapy was administered until disease progression or withdrawal.
488579|NCT00387127|E1|Reported Event|Chemoradiotherapy + Placebo, Followed by Placebo|Participants received radiotherapy once daily (OD), with a dose/fraction less than 2.5 Gray (Gy) to a total dose of 70 Gy (using two-dimensional [2D] or 3D techniques) or 65 Gy (using Intensity Modulated Radiation Therapy [IMRT]) to the gross site of disease. Concurrent chemotherapy of cisplatin 100 milligrams per meters squared (mg/m^2) was administered intravenously (IV) on Days 1, 22, and 43 of the course of radiotherapy (Study Days 8, 29, and 50). Matching placebo administration commenced 1 week (or less than or equal to 3 days) prior to the concurrent administration with chemoradiation for a duration of up to 6 to 7 weeks. After the completion of chemoradiotherapy, placebo monotherapy was administered until disease progression or withdrawal.
488580|NCT00387088|B3|Baseline|Total|Total of all reporting groups
488581|NCT00387088|B2|Baseline|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488582|NCT00387088|B1|Baseline|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488583|NCT00387088|P2|Participant Flow|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488584|NCT00387088|P1|Participant Flow|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488585|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488586|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488587|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488588|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488589|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488590|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488591|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488592|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488593|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488594|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488596|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488597|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488598|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488599|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488600|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488601|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488602|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488603|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488604|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488605|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488606|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488607|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488608|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488609|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488610|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488611|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488612|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488613|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488614|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488615|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488616|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488617|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488618|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488619|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488620|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488621|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488622|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488623|NCT00387088|O2|Outcome|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488624|NCT00387088|O1|Outcome|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488625|NCT00387088|E2|Reported Event|Placebo|Placebo via Respimat® inhaler (2 inhalations per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488626|NCT00387088|E1|Reported Event|Tiotropium|Tiotropium 5µg via Respimat® inhaler (2 inhalations of 2.5µg per day) + usual maintenance treatment (only anticholinergic bronchodilators were excluded)
488627|NCT00387036|B1|Baseline|Entire Study Population|
488628|NCT00387036|P2|Participant Flow|Placebo Then Fluticasone Propionate|Following 1 week Placebo run-in period (Period I), patients were randomized to receive placebo 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week fluticasone propionate 250 mcg HFA 2 inhalations twice daily (Period IV).
488629|NCT00387036|P1|Participant Flow|Fluticasone Propionate Then Placebo|Following 1 week Placebo run-in period (Period I), patients were randomized to receive fluticasone propionate 250 mcg Hydrofluoroalkane (HFA) 2 inhalations twice daily for a 2-week period (Period II) followed by 2-week washout period (Period III) and 2-week placebo 2 inhalations twice daily (Period IV).
488630|NCT00387036|O2|Outcome|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
488631|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
488633|NCT00387036|O1|Outcome|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
488634|NCT00387036|E2|Reported Event|Placebo|Placebo administered 2 inhalations twice daily in first or second intervention
488635|NCT00387036|E1|Reported Event|Fluticasone Propionate|Fluticasone Propionate 250 mcg HFA (hydrofluoroalkane) administered 2 inhalations twice daily in first or second intervention
488636|NCT00387023|B1|Baseline|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
488637|NCT00387023|P1|Participant Flow|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 millicurie (mCi)/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
488638|NCT00387023|O1|Outcome|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
488639|NCT00387023|E1|Reported Event|Zevalin + Rituximab|Rituximab 250 mg/m^2 intravenous (IV) over 4-6 hours for 2 weeks, + Zevalin 5 mCi/kg IV over 30 minutes for 1 week, followed by 0.3 mCi/kg or 0.4 mCi/kg 90Y-Zevalin based on platelet counts for 1 week.
488640|NCT00387010|B1|Baseline|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488641|NCT00387010|P1|Participant Flow|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488642|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488643|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488644|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488645|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488646|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488647|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488648|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488649|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488650|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488651|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488652|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488653|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488654|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488655|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488656|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488657|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488658|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488762|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488763|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488659|NCT00387010|O1|Outcome|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488660|NCT00387010|E1|Reported Event|Fentanyl Buccal Tablets|Successful dose strength for each participant was determined during a titration period of no more than 10 days. Participants used the successful dose of 100, 200, 400, 600, or 800 mcg during the four week open-label treatment period.
488661|NCT00386880|B1|Baseline|Subjects With Episodic Migraine|Subjects with less than 8 distict migraine episodes per month.
488662|NCT00386880|P2|Participant Flow|Subjects With Episodic Migraine Without Allodynia|These are the subjects with episodic migraine without allodynia.
488663|NCT00386880|P1|Participant Flow|Subjects With Episodic Migraine With Allodynia|These are the subjects with episodic migraine with allodynia.
488664|NCT00386880|O2|Outcome|Subjects With Episodic Migraine Without Allodynia|These are subjects with episodic migraine without allodynia
488665|NCT00386880|O1|Outcome|Subjects With Episodic Migraine With Allodynia|These are subjects with episodic migraine with allodynia
488666|NCT00386880|E1|Reported Event|Subjects With Episodic Migraine|
488667|NCT00386776|B1|Baseline|Experimental|The intervention is a computer-based medical interview, which contains 232 primary questions that are asked of all respondents, and over 6000 frames (questions, explanations, suggestions, recommendations, and words of encouragement) that are available for presentation as determined by the patient's responses and the branching logic of the program.
488668|NCT00386776|P1|Participant Flow|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
488669|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
488670|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
488671|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
488672|NCT00386776|O1|Outcome|Computer-based Medical History|The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses
488673|NCT00386776|O1|Outcome|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
488674|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
488675|NCT00386776|O1|Outcome|Computer-based Medical History|A computer-based medical history to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like.
488707|NCT00386425|P3|Participant Flow|Randomized Non-ITT Population|Participants were randomized to either the Standard or Alternative Therapy and received 24 mcg/kg/hr during the first 24 hours (common therapy period); however, they did not continue on to receive the actual randomized therapy.
488708|NCT00386425|P2|Participant Flow|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488709|NCT00386425|P1|Participant Flow|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488676|NCT00386776|E1|Reported Event|Computer-based Medical History|"The intervention is a computer-based medical history designed for patients to take in their homes via the Internet. The history is divided into 24 modules— family history, social history, cardiac history, pulmonary history, and the like. So far as possible, it is designed to model the comprehensive, inclusive, general medical history traditionally taken, when time permits, by a primary care doctor seeing a patient for the first time. It contains 232 primary questions asked of all patients about the presence or absence of medical problems. Of these, 215 have the preformatted mutually exclusive responses Yes, No, Uncertain (Don't Know, Maybe), Don't understand, and I'd rather not answer; 10 have other sets of multiple choices, one response permitted; five have multiple choices with more than one response permitted, and two have numerical responses. There are also 6000 questions, explanations and suggestions, available for presentation dependent upon the patient's responses,"
488677|NCT00386607|B1|Baseline|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488678|NCT00386607|P2|Participant Flow|Extension Treatment|"For patients entering into extension, those previously treated with HCTZ (12.5 or 25 mg) in addition to aliskiren 300 mg/valsartan 320 mg were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 25 mg in the extension.~Those patients who had not received HCTZ during the core study were treated with aliskiren 300 mg/valsartan 320 mg/HCTZ 12.5 mg.~The HCTZ 12.5 mg dose could be increased to HCTZ 25 mg if the msSBP was ≥140 mmHg and/or the msDBP was ≥90 mmHg for 2 consecutive visits."
488679|NCT00386607|P1|Participant Flow|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488680|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
488681|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
488682|NCT00386607|O1|Outcome|Core and Extension Treatment - Aliskiren/Valsartan/HCTZ|All patients receiving aliskiren / valsartan / HCTZ during either core or extension study.
488683|NCT00386607|O1|Outcome|Extension Treatment|All patients receiving aliskiren / valsartan / HCTZ in extension study.
488684|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488685|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488686|NCT00386607|O1|Outcome|Core Treatment|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488687|NCT00386607|O1|Outcome|Core Treatment- Aliskiren/Valsartan & Aliskiren/Valsartan/HCTZ|Oral pills of aliskiren 150 mg /valsartan 160 mg in combination for 2-weeks. The aliskiren 300 mg /valsartan 320 mg in combiniation for 52-weeks, optional addition of HCTZ 12.5 mg starting from Week 10 if the blood pressure was uncontrolled (msSBP ≥ 140 and/or msDBP ≥ 90 mmHg). The dose of HCTZ 12.5 mg could be increased to 25 mg if blood pressure remained uncontrolled.
488688|NCT00386607|E6|Reported Event|Core and Extension: Total|Core and Extension: Total includes all study patients, treated with Aliskiren/Valsartan or Aliskiren//valsartan/HCTZ during core or extension.
488689|NCT00386607|E5|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 25 mg|Core and Extension: Aliskiren/Valsartan/HCTZ 25 mg
488690|NCT00386607|E4|Reported Event|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg|Core and Extension: Aliskiren / Valsartan / HCTZ 12.5 mg
488691|NCT00386607|E3|Reported Event|Core Period: Aliskiren / Valsartan|Core Period: Aliskiren/Valsartan
488692|NCT00386607|E2|Reported Event|Core Period: Aliskiren 300 mg / Valsartan 320 mg Alone|Core Period: Aliskiren 300 mg /Valsartan 320 mg alone
488693|NCT00386607|E1|Reported Event|Core Period: Aliskiren 150 mg / Valsartan 160 mg Alone|Core Period: Aliskiren 150 mg /Valsartan 160 mg alone
488694|NCT00386477|B3|Baseline|Total|Total of all reporting groups
488695|NCT00386477|B2|Baseline|Control|No vaginal cleansing or sham wash performed.
488696|NCT00386477|B1|Baseline|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
488697|NCT00386477|P2|Participant Flow|Control|No vaginal cleansing or sham wash performed.
488698|NCT00386477|P1|Participant Flow|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
488699|NCT00386477|O2|Outcome|Control|No vaginal cleansing or sham wash performed.
488700|NCT00386477|O1|Outcome|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
488701|NCT00386477|E2|Reported Event|Control|No vaginal cleansing or sham wash performed.
488702|NCT00386477|E1|Reported Event|Vag Prep|Vagina cleansed with betadine vaginal scrub sticks prior to performing cesarean
488703|NCT00386425|B4|Baseline|Total|Total of all reporting groups
488704|NCT00386425|B3|Baseline|Randomized Non-ITT Population|
488705|NCT00386425|B2|Baseline|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488706|NCT00386425|B1|Baseline|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488758|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488710|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488711|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488712|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488713|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488714|NCT00386425|O2|Outcome|Did Not Normalize Protein C|
488715|NCT00386425|O1|Outcome|Normalized Protein C|
488716|NCT00386425|O4|Outcome|Alternative Therapy - Moderate Deficiency|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours
488717|NCT00386425|O3|Outcome|Alternative Therapy - Severe Deficiency|Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488718|NCT00386425|O2|Outcome|Standard Therapy - Moderate Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488719|NCT00386425|O1|Outcome|Standard Therapy - Severe Deficiency|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488720|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488721|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488722|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488723|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488724|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488725|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488726|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488727|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488728|NCT00386425|O2|Outcome|Alternative Therapy|Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours
488729|NCT00386425|O1|Outcome|Standard Therapy|24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours
488730|NCT00386425|E2|Reported Event|Alternative Therapy|Participants assigned to alternative therapy (Moderate Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 to 144 hours Severe Protein C Deficiency: 24 mcg/kg/hr for 24 hours, followed by 30 or 36 mcg/kg/hr for an additional 72 to 144 hours) who received any amount of study drug.
488731|NCT00386425|E1|Reported Event|Standard Therapy|Participants assigned to standard therapy (24 mcg/kg/hr for 24 hours, followed by 24 mcg/kg/hr for an additional 72 hours) who received any amount of study drug.
488732|NCT00386360|B3|Baseline|Total|Total of all reporting groups
488733|NCT00386360|B2|Baseline|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488734|NCT00386360|B1|Baseline|Placebo|Placebo, 1 tablet weekly on the same day
488735|NCT00386360|P2|Participant Flow|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488736|NCT00386360|P1|Participant Flow|Placebo|Placebo, 1 tablet weekly on the same day
488737|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488738|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488739|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488740|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488741|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488742|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488743|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488744|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488745|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488746|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488747|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488748|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488749|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488750|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488751|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488752|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488753|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488754|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488755|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488756|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488757|NCT00386360|O2|Outcome|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488764|NCT00386360|O1|Outcome|Placebo|Placebo, 1 tablet weekly on the same day
488765|NCT00386360|E2|Reported Event|Risedronate|35 mg risedronate tablet, orally, once weekly on the same day
488766|NCT00386360|E1|Reported Event|Placebo|Placebo, 1 tablet weekly on the same day
488767|NCT00386334|B3|Baseline|Total|Total of all reporting groups
488768|NCT00386334|B2|Baseline|Eszopiclone|Eszopiclone 2 mg tablets
488769|NCT00386334|B1|Baseline|Placebo|Placebo tablets
488770|NCT00386334|P2|Participant Flow|Eszopiclone|Eszopiclone 2 mg tablets
488771|NCT00386334|P1|Participant Flow|Placebo|Placebo tablets
488772|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488773|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488774|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488775|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488776|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488777|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488778|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488779|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488780|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488781|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488782|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488783|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488784|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488785|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488786|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488787|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488788|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488789|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488790|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488791|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488792|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488793|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488794|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488795|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488796|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488797|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488798|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488799|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488800|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488801|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488802|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488803|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488804|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488805|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488806|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488807|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488808|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488809|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488810|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488811|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488812|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488813|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488814|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488815|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488816|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488817|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488818|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488819|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488820|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488821|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488822|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488823|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488824|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488825|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488826|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488827|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488828|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488829|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488830|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488831|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488832|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488833|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488834|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488835|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488836|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488837|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488838|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488839|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488840|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488841|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488842|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488843|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488844|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488845|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488846|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488847|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488848|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488849|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488850|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488851|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488852|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488853|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488854|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488869|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488870|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488871|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488872|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488873|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488874|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488875|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488876|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488877|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488878|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488879|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488880|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488881|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488882|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488883|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488884|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488885|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488886|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488887|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488888|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488889|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488890|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488891|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488892|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488893|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488894|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488895|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488896|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488897|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488898|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488899|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488900|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488901|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488902|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488903|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488904|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488905|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488906|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488907|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488908|NCT00386334|O2|Outcome|Eszopiclone|Eszopiclone 2 mg tablets
488909|NCT00386334|O1|Outcome|Placebo|Placebo tablets
488910|NCT00386334|E2|Reported Event|Eszopiclone|Eszopiclone 2 mg tablets
488911|NCT00386334|E1|Reported Event|Placebo|Placebo tablets
488912|NCT00386308|B3|Baseline|Total|Total of all reporting groups
488913|NCT00386308|B2|Baseline|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488914|NCT00386308|B1|Baseline|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488915|NCT00386308|P2|Participant Flow|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488916|NCT00386308|P1|Participant Flow|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488917|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488918|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488919|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488920|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488921|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488922|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488923|NCT00386308|O2|Outcome|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488924|NCT00386308|O1|Outcome|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488925|NCT00386308|E2|Reported Event|Placebo|Two placebo tablets taken 3 times daily for a maximum of 5 days during monthly menstruation
488926|NCT00386308|E1|Reported Event|3900 mg/Day|Two 650 mg Lysteda (tranexamic acid) tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
488927|NCT00386256|B5|Baseline|Total|Total of all reporting groups
488928|NCT00386256|B4|Baseline|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
488929|NCT00386256|B3|Baseline|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
488930|NCT00386256|B2|Baseline|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
488931|NCT00386256|B1|Baseline|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
488932|NCT00386256|P4|Participant Flow|Telephone Inpatient|
488933|NCT00386256|P3|Participant Flow|Health Buddy Inpatient|
488934|NCT00386256|P2|Participant Flow|Telephone Outpatient|
488935|NCT00386256|P1|Participant Flow|Health Buddy Outpatient|Health Buddy(R), Home telehealth technology : Exercise questions, educational messages, and clinical reminders have been programmed into the home telehealth technology and are administered daily via the Health Buddy(R) to evaluate the program's feasibility based on adherence rates, program completion rates, and safety.
488936|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
488937|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
490630|NCT00382408|O1|Outcome|Vaccine|Oral Type-7 vaccine
488938|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
488939|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
488940|NCT00386256|O4|Outcome|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
488941|NCT00386256|O3|Outcome|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
488942|NCT00386256|O2|Outcome|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
488943|NCT00386256|O1|Outcome|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
488944|NCT00386256|E4|Reported Event|Telephone Inpatient|Received telephone counseling, recruited from inpatient setting
488945|NCT00386256|E3|Reported Event|Health Buddy Inpatient|Received Health Buddy, recruited from inpatient setting
488946|NCT00386256|E2|Reported Event|Telephone Outpatient|Received telephone counseling, recruited from outpatient setting
488947|NCT00386256|E1|Reported Event|Health Buddy Outpatient|Received Health Buddy, recruited from outpatient setting
488948|NCT00386243|B3|Baseline|Total|Total of all reporting groups
488949|NCT00386243|B2|Baseline|Arm 2|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
488950|NCT00386243|B1|Baseline|Arm 1|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
488951|NCT00386243|P2|Participant Flow|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
488952|NCT00386243|P1|Participant Flow|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
488953|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
488954|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
488955|NCT00386243|O2|Outcome|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
488956|NCT00386243|O1|Outcome|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
488957|NCT00386243|E2|Reported Event|Stepped Care|"Study subjects randomized to this arm would receive stepped care for their pain. Stepped care involves FDA-approved analgesic therapy, a 12-week pain self-management program, and if pain does not improve, a 12-week cognitive behavioral therapy program.~Pain self-management program : The pain self-management program is delivered by a nurse care-manager during a 12-week period. Sessions are each 45 minutes long and phone-based. They occur at baseline, week 1, week 3, week 6, week 9, and week 12.~Cognitive behavioral therapy : Cognitive behavioral therapy is delivered by phone by a nurse care-manager 6 times over a 12-week period. Sessions last approximately 45 minutes and occur at weeks 14, 16, 18, 20, 22, and 24 of the study.~Co-Analgesic Therapy"
488958|NCT00386243|E1|Reported Event|Usual Care|Study subjects randomized to this arm would receive usual care from their provider(s). No study intervention is undertaken on subjects in this arm. Participants in Usual Care would complete the same four outcome assessments (surveys) throughout the course of the study that members of the intervention complete.
488959|NCT00386152|B4|Baseline|Total|Total of all reporting groups
488960|NCT00386152|B3|Baseline|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488961|NCT00386152|B2|Baseline|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
490631|NCT00382408|O2|Outcome|Placebo|Oral Type-4 Placebo
488962|NCT00386152|B1|Baseline|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488963|NCT00386152|P3|Participant Flow|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488964|NCT00386152|P2|Participant Flow|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488965|NCT00386152|P1|Participant Flow|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488966|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488967|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488968|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488969|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488970|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488971|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488972|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488973|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488974|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488975|NCT00386152|O3|Outcome|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488976|NCT00386152|O2|Outcome|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488977|NCT00386152|O1|Outcome|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488978|NCT00386152|E3|Reported Event|Darbepoetin Alfa (500 Mcg)|darbepoetin alfa (ARANESP) 500 mcg SC Q3W for up to 13 weeks
488979|NCT00386152|E2|Reported Event|Epoetin Alfa (120,000 Units)|epoetin alfa (PROCRIT) 120,000 Units SC Q3W for up to 13 weeks
488980|NCT00386152|E1|Reported Event|Epoetin Alfa (80,000 Units)|epoetin alfa (PROCRIT) 80,000 Units subcutaneous (SC) once every 3 weeks (Q3W) for up to 13 weeks
488981|NCT00386100|B3|Baseline|Total|Total of all reporting groups
488982|NCT00386100|B2|Baseline|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488983|NCT00386100|B1|Baseline|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488984|NCT00386100|P2|Participant Flow|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488985|NCT00386100|P1|Participant Flow|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488986|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488987|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488988|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488989|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488990|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488991|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488992|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488993|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488994|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488995|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488996|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488997|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
488998|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
488999|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489000|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489001|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489002|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489003|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489004|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489005|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489006|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489051|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489007|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489008|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489009|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489010|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489011|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489012|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489013|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489014|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489015|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489016|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489017|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489018|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489019|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489020|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489021|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489022|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489023|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489024|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489025|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489026|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489027|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489028|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489029|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489030|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489031|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489032|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489033|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489034|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489035|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489036|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489037|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489038|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489039|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489040|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489041|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489042|NCT00386100|O2|Outcome|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489043|NCT00386100|O1|Outcome|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489044|NCT00386100|E2|Reported Event|Avandamet|Beginning dose of Avandamet (AVM) 4 mg/500 mg once a day. Dose could be increased up to a maximum dose of 8 mg/2000 mg.
489045|NCT00386100|E1|Reported Event|Metformin|Beginning dose of Metformin (MET) 500 milligrams (mg) once a day. Dose could be increased up to a maximum dose of MET 2000 mg.
489046|NCT00386009|B3|Baseline|Total|Total of all reporting groups
489047|NCT00386009|B2|Baseline|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489048|NCT00386009|B1|Baseline|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489049|NCT00386009|P2|Participant Flow|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489050|NCT00386009|P1|Participant Flow|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489052|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489053|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489054|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489055|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489056|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489057|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489058|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489059|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489060|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489061|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489062|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489063|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489064|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489065|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489066|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489067|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489068|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489069|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489070|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489071|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489072|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489073|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489074|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489075|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489076|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489077|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489078|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489079|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489080|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489081|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489082|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489083|NCT00386009|O2|Outcome|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489084|NCT00386009|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489085|NCT00386009|E2|Reported Event|Tadalafil|20 mg tadalafil tablet taken by mouth once a day for 12 weeks
489086|NCT00386009|E1|Reported Event|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489087|NCT00385996|B1|Baseline|Erlotinib|Erlotinib 150 mg po daily
489088|NCT00385996|P1|Participant Flow|Erlotinib|Erlotinib 150 mg po daily.
489089|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
489090|NCT00385996|O1|Outcome|Erlotinib|Erlotinib 150 mg po daily
489091|NCT00385996|E1|Reported Event|Erlotinib|Erlotinib 150 mg po daily.
489092|NCT00385944|B3|Baseline|Total|Total of all reporting groups
489093|NCT00385944|B2|Baseline|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
489094|NCT00385944|B1|Baseline|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose) followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
489095|NCT00385944|P3|Participant Flow|Loading Dose|Clopidogrel 900-mg Loading Dose (a single or cumulative dose)
489096|NCT00385944|P2|Participant Flow|Clopidogrel/Prasugrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of prasugrel 10 mg and 100 mg aspirin for an additional 14 days.
489097|NCT00385944|P1|Participant Flow|Prasugrel/Clopidogrel|One time oral loading dose (LD) of 900-mg clopidogrel (a single or cumulative dose)followed by a once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days. Patients cross-over to a daily MD of clopidogrel 150 mg and 100 mg aspirin for an additional 14 days.
489098|NCT00385944|O1|Outcome|Intent-to-treat Population|Both clopidogrel and prasugrel combined population
489099|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489100|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489101|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489102|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489103|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
489104|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
489105|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD) or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
489106|NCT00385944|O1|Outcome|Prasugrel/Clopidogrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
489107|NCT00385944|O2|Outcome|Clopidogrel/Prasugrel|Clopidogrel (150-mg MD)or Prasugrel (10-mg MD) + Aspirin (≤100-mg MD)
489108|NCT00385944|O1|Outcome|Prasugrel/Clopidgrel|Prasugrel (10-mg MD) or Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD)
489109|NCT00385944|O1|Outcome|Clopidogrel 900 mg|Clopidogrel 900 mg LD (a single or cumulative dose)
489110|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489111|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489112|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489113|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489114|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489115|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489116|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489117|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489118|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489119|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489120|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489121|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489122|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489123|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489124|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489125|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489126|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489127|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489128|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489129|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489130|NCT00385944|O2|Outcome|Clopidogrel|Clopidogrel (150-mg MD) + Aspirin (≤100-mg MD) (Clopidogrel + Aspirin is administered once daily, either in the first or second MD periods)
489131|NCT00385944|O1|Outcome|Prasugrel|Prasugrel (10-mg MD) + Aspirin (≤100-mg MD) (Prasugrel + Aspirin is administered once daily, either in the first or second MD period)
489132|NCT00385944|E5|Reported Event|Prasugrel 10 mg - Crossover From Clopidogrel 150 mg|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of clopidogrel 150 mg and 100 mg aspirin during the 1st MD period.
489133|NCT00385944|E4|Reported Event|Clopidogrel 150 mg - Crossover From Prasugrel 10 mg|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for an additional 14 days. These are patients who received a daily MD of prasugrel 10 mg and 100 mg aspirin during the 1st MD period.
489134|NCT00385944|E3|Reported Event|Clopidogrel 150 mg - 1st MD|Once daily MD of clopidogrel 150 mg and 100 mg aspirin, for 14 days.
489135|NCT00385944|E2|Reported Event|Prasugrel 10 mg - 1st MD|Once daily MD of prasugrel 10 mg and 100 mg aspirin, for 14 days.
489136|NCT00385944|E1|Reported Event|Clopidogrel 900 mg LD|One time oral loading dose (LD) of 900-mg clopidogrel
489137|NCT00385918|B3|Baseline|Total|Total of all reporting groups
489138|NCT00385918|B2|Baseline|Home Stretching Then Lokomat Exercise|"Patients will participate in a home stretching program for 3 months. They will then be crossed over to Lokomat treatment for an additional 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm."
489139|NCT00385918|B1|Baseline|Lokomat Exercise|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489140|NCT00385918|P3|Participant Flow|Baseline and Feasibility Testing|All subjects were screened and underwent baseline testing prior to randomization into either the Lokomat training or the Home stretching then Lokomat training group.
489173|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489141|NCT00385918|P2|Participant Flow|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~After 3 months the participants will be switched to a 3 month period of Lokomat training the same as that offered to the patients randomized to the Lokomat Training arm of the study."
489142|NCT00385918|P1|Participant Flow|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489143|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489144|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489145|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489146|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489147|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489148|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489149|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489150|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489151|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489152|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489153|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489154|NCT00385918|O1|Outcome|Lokomat Treatment|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489294|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489155|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489156|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489157|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489158|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489159|NCT00385918|O2|Outcome|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.~The stretching group will cross-over to the exercise intervention after completion of the 3-month home-base phase. At that time, they will receive an exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes."
489160|NCT00385918|O1|Outcome|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489161|NCT00385918|E2|Reported Event|Home Stretching Then Lokomat Training|"Patients will participate in a home stretching program for 3 months.~Home stretching protocol : Patients will be instructed by a physical therapist on how to perform a home stretching protocol 3 times per week for 3 months. The stretching will be monitored via telephone by the study coordinator. This will be an active control arm.This group will switch to the 3-month robotic intervention after completing the home-based training program."
489162|NCT00385918|E1|Reported Event|Lokomat Training|"Subjects will receive active exercise treatment in the Lokomat device 3 times per week for 3 months. Each session will last approximately 45 minutes.~Lokomat Training : The Lokomat is a robotically assisted partial weight suspension treadmill training device that has the potential to restore leg function in persons with incomplete leg paralysis."
489163|NCT00385840|B3|Baseline|Total|Total of all reporting groups
489164|NCT00385840|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489165|NCT00385840|B1|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489166|NCT00385840|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489167|NCT00385840|P1|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489168|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489169|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489170|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489171|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489172|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489295|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
490534|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
489174|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489175|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489176|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489177|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489178|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489179|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489180|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489181|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489182|NCT00385840|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489183|NCT00385840|O1|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489184|NCT00385840|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the GSK1247446A vaccine in study NCT00321763, received 1 dose of adjuvanted GSK1247446A vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489185|NCT00385840|E1|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of re-vaccination, who previously received 1 dose of the Fluarix™ vaccine in study NCT00321763, received 1 dose of Fluarix™ vaccine in this study. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
489186|NCT00385827|B4|Baseline|Total|Total of all reporting groups
489187|NCT00385827|B3|Baseline|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489188|NCT00385827|B2|Baseline|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489189|NCT00385827|B1|Baseline|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489190|NCT00385827|P3|Participant Flow|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489191|NCT00385827|P2|Participant Flow|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489205|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
490535|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
489192|NCT00385827|P1|Participant Flow|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489193|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489194|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489195|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489196|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489197|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489198|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489199|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489200|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489201|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489202|NCT00385827|O3|Outcome|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489203|NCT00385827|O2|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489204|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489742|NCT00384930|E3|Reported Event|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489206|NCT00385827|O1|Outcome|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489207|NCT00385827|O1|Outcome|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489208|NCT00385827|E3|Reported Event|Part 2: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute infusion on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab 6 mg/kg intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489209|NCT00385827|E2|Reported Event|Part 2: Mitoxantrone + Prednisone|Participants received mitoxantrone 12 mg/m^2 intravenously as a 30-minute on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with prednisone 5 mg orally twice daily starting with the first administration of mitoxantrone.
489210|NCT00385827|E1|Reported Event|Part 1: Mitoxantrone + Prednisone + Siltuximab|Participants received mitoxantrone 12 milligram per square meter (mg/m^2) intravenously (into a vein) as a 30-minute infusion (a fluid or a medicine delivered into a vein by way of a needle) on Day 1 of each 3-week cycle until disease progression or unacceptable toxicity or up to 10 cycles (a maximum cumulative dose of approximately 120 mg/m^2) along with siltuximab (CNTO 328) 6 milligram per kilogram (mg/kg) intravenously as a 2-hour infusion every 2 weeks until disease progression or unacceptable toxicity or up to a maximum of 1 year; and prednisone 5 milligram (mg) orally twice daily starting with the first administration of mitoxantrone.
489211|NCT00385736|B4|Baseline|Total|Total of all reporting groups
489212|NCT00385736|B3|Baseline|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489213|NCT00385736|B2|Baseline|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489214|NCT00385736|B1|Baseline|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489215|NCT00385736|P3|Participant Flow|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489216|NCT00385736|P2|Participant Flow|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489217|NCT00385736|P1|Participant Flow|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489218|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489219|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489220|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489221|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489222|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489223|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489224|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489225|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489226|NCT00385736|O1|Outcome|Total|All subjects who received at least 1 dose of adalimumab or placebo
489227|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489228|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489229|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489230|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489231|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489232|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489233|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489234|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489235|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489293|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489236|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489237|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489238|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489239|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489240|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489241|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489242|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489243|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489244|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489245|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489246|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489247|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489248|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489249|NCT00385736|O2|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489250|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489251|NCT00385736|O3|Outcome|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4.
489252|NCT00385736|O2|Outcome|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4.
489253|NCT00385736|O1|Outcome|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6, followed by 160 mg adalimumab at Week 8, 80 mg adalimumab at Week 10, and 40 mg adalimumab thereafter (prior to Amendment 3) or 40 mg adalimumab eow starting at Week 8 (after Amendment 3).
489254|NCT00385736|E4|Reported Event|Any Adalimumab|Treatment group received at least 1 dose of adalimumab during the study. Adverse events include those reported from the first dose of adalimumab during the double-blind or open-label period.
489255|NCT00385736|E3|Reported Event|Adalimumab 160/80/40|Treatment group received 160 mg at Week 0, 80 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
489256|NCT00385736|E2|Reported Event|Adalimumab 80/40|Treatment group received 80 mg at Week 0, 40 mg at Week 2, and 40 mg every other week starting at Week 4. Adverse events include those reported prior to dosing at Week 8.
489257|NCT00385736|E1|Reported Event|Placebo|Treatment group received placebo at Weeks 0, 2, 4, and 6. Adverse events include those reported prior to dosing at Week 8.
489258|NCT00385723|B4|Baseline|Total|Total of all reporting groups
489259|NCT00385723|B3|Baseline|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489260|NCT00385723|B2|Baseline|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489261|NCT00385723|B1|Baseline|Placebo|Placebo : matching placebo capsule daily for 4 months
489262|NCT00385723|P3|Participant Flow|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489263|NCT00385723|P2|Participant Flow|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489264|NCT00385723|P1|Participant Flow|Placebo|Placebo : matching placebo capsule daily for 4 months
489265|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489266|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489267|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
489268|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489269|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489270|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
489271|NCT00385723|O3|Outcome|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489272|NCT00385723|O2|Outcome|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489273|NCT00385723|O1|Outcome|Placebo|Placebo : matching placebo capsule daily for 4 months
489274|NCT00385723|E3|Reported Event|2.5 g/d n-3|Omega 3 (Fish Oil) Supplementation : 2.496 g daily for 4 months
489275|NCT00385723|E2|Reported Event|1.25 g/d n-3|Omega 3 (Fish Oil) Supplementation : 1.25 g daily for 4 months
489276|NCT00385723|E1|Reported Event|Placebo|Placebo : matching placebo capsule daily for 4 months
489743|NCT00384930|E2|Reported Event|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489277|NCT00385684|B1|Baseline|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489278|NCT00385684|P2|Participant Flow|A2 THEN A1 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489279|NCT00385684|P1|Participant Flow|A1 and Then A2 Then Phase B|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489280|NCT00385684|O1|Outcome|Phase B: Open Label|Those participants for whom the study medication was tolerated during Phase A (i.e., the closed label, double-blind phase of the trial) entered a six-week open-label phase.
489281|NCT00385684|O2|Outcome|Placebo Comparator: A2|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489282|NCT00385684|O1|Outcome|Experimental: A1|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489283|NCT00385684|E1|Reported Event|ALL STUDY PARTICIPANTS|"This is a fully crossed study, each participant serves as his own control. Phase A: Participants are randomized to either A1 for 1 week then A2 for 1 week OR A2 for 1 week then A1 for one week. A1: hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid TID, with liquid placebo available PRN. A2: liquid placebo TID with hydrocodone/acetaminophen 2.5/167 mg per 5 ml liquid PRN.~Phase B: If tolerated study medication during Phase A (i.e., the closed label, double-blind phase of the trial) then enter a six-week, open-label phase. Participants judged as responders during Phase A continue the same dose of study medication. Otherwise, moved to a higher dose (hydrocodone/acetaminophen 5/500mg TID or the most appropriate formulary alternative). Participant can also receive up to 2 PRN administrations at the same dose levels as listed above, but not to exceed 2.5g of acetaminophen."
489284|NCT00385671|B4|Baseline|Total|Total of all reporting groups
489285|NCT00385671|B3|Baseline|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489286|NCT00385671|B2|Baseline|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489287|NCT00385671|B1|Baseline|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489288|NCT00385671|P3|Participant Flow|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489289|NCT00385671|P2|Participant Flow|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489290|NCT00385671|P1|Participant Flow|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489291|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489292|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489744|NCT00384930|E1|Reported Event|Placebo|placebo tablet by mouth once a day for twelve weeks
489296|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489297|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489298|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489299|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489300|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489301|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489302|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489303|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489304|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489305|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489306|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489307|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489308|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489309|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489310|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489311|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489312|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489313|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489314|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489315|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489316|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489317|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489318|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489319|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489320|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489321|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489322|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489323|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489324|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489325|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489326|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489327|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489328|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489329|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489745|NCT00384813|B3|Baseline|Total|Total of all reporting groups
489330|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489331|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489332|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489333|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489334|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489335|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489336|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489337|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489338|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489339|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489340|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489341|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489342|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489343|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489344|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489345|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489346|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489347|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489348|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489349|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489350|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489351|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489352|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489353|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489354|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489355|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489356|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489357|NCT00385671|O1|Outcome|Ordinary Coefficient|Beta-coefficient from regression analyses estimating direct and indirect treatment effects expressed in the observed scale of measurement of the dependent variable.
489358|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489359|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489360|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489361|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489362|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489363|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489828|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489364|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489365|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489366|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489367|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489368|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489369|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489370|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489371|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489372|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489373|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489374|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489375|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489376|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489377|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489378|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489379|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489380|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489381|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489382|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489383|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489384|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489385|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489386|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489387|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489388|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489389|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489390|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489391|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489392|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489393|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489394|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489395|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489396|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489397|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489398|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489399|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489400|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489401|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489402|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489403|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489404|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489405|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489406|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489407|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489408|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489409|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489410|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489411|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489412|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489413|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489414|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489415|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489416|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489417|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489418|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489419|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489420|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489421|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489422|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489423|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489424|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489425|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489426|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489427|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489428|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489429|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489430|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489431|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489432|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489829|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489433|NCT00385671|O3|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489434|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489435|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489436|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489437|NCT00385671|O1|Outcome|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489438|NCT00385671|O2|Outcome|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489439|NCT00385671|O1|Outcome|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489440|NCT00385671|E3|Reported Event|Gabapentin + Duloxetine|Stable Gabapentin (GAB) + Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then stable GAB + DLX 60 mg QD, PO for 11 weeks.
489441|NCT00385671|E2|Reported Event|Duloxetine|Duloxetine (DLX) 30 milligram (mg) once daily (QD), orally (PO) for 1 week, then DLX 60 mg QD, PO for 11 weeks.
489442|NCT00385671|E1|Reported Event|Pregabalin|Pregabalin (PGB) 50 milligram (mg) three times a day (TID) (US & Germany) or 75 mg twice daily (BID) (Canada), orally (PO) for 2 weeks, then PGB 100 mg TID (US & Germany) or 150 mg BID (Canada), PO for 10 weeks.
489443|NCT00385593|B3|Baseline|Total|Total of all reporting groups
489444|NCT00385593|B2|Baseline|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489445|NCT00385593|B1|Baseline|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489446|NCT00385593|P2|Participant Flow|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489447|NCT00385593|P1|Participant Flow|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489448|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489449|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489450|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489451|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489452|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489453|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489454|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489455|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489456|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489457|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489458|NCT00385593|O2|Outcome|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489459|NCT00385593|O1|Outcome|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489460|NCT00385593|E2|Reported Event|Conv. Best Practice|Conventional best practice, active stepwise individualized treatment according to international asthma treatment guidelines (GINA guidelines)); stepwise treatment according to the investigator’s clinical judgement.
489461|NCT00385593|E1|Reported Event|SMART|Symbicort Turbuhaler 160/4.5μg, 1 inhalation b.i.d. + as needed (in response to symptoms)
489462|NCT00385580|B3|Baseline|Total|Total of all reporting groups
489463|NCT00385580|B2|Baseline|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489464|NCT00385580|B1|Baseline|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489586|NCT00385268|O1|Outcome|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
489465|NCT00385580|P2|Participant Flow|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489466|NCT00385580|P1|Participant Flow|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489467|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (X dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489468|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (X dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489469|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489470|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (50 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489471|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (50 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489472|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (50 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489473|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489474|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489475|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489476|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (70 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489587|NCT00385268|E2|Reported Event|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
489588|NCT00385268|E1|Reported Event|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
490536|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
489477|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (70 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489478|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (70 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489479|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489480|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489481|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489482|NCT00385580|O3|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 70 mg BID for a TDD of 140 mg (100 dose). Of the 47 treated participants in the BID group, 22 received 70 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489483|NCT00385580|O2|Outcome|Dasatinib 100 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg (100 dose). Of the 47 treated participants in the BID group, 25 received 100 mg of dasatinib as their starting dose. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489484|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD (100 dose). Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489485|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489486|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489487|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489488|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489589|NCT00385216|B1|Baseline|Entire Study Population|The baseline characteristics for the entire study population are presented here. The nicotine and placebo study populations were identical.
489590|NCT00385216|P2|Participant Flow|Placebo Spray First, Then Nicotine|At the first intervention, the subject will receive a placebo nasal spray, 0 mg, one application. At the second intervention, the subject will receive a nicotine nasal spray, 3 mg, one application.
490537|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
489489|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489490|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489491|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489492|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489493|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489494|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489495|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489496|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489497|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489498|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489499|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489500|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489591|NCT00385216|P1|Participant Flow|Nicotine Nasal Spray First, Then Placebo|At the first intervention, the subject will receive a nicotine nasal spray, 3 mg, one application. At the second intervention, the subject will receive a placebo nasal spray, 0 mg, one application.
489592|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489501|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489502|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489503|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489504|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489505|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489506|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489507|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489508|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489509|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489510|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489511|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489512|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489593|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489594|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489513|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489514|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489515|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489516|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489517|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489518|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489519|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489520|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489521|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489522|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489523|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489524|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489595|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489596|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489525|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489526|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489527|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489528|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489529|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489530|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489531|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489532|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489533|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489534|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489535|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489536|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489597|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489598|NCT00385216|O2|Outcome|Placebo|Sterile saline placebo was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489537|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489538|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489539|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489540|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489541|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489542|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489543|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489544|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489545|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489546|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489547|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489548|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489599|NCT00385216|O1|Outcome|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489600|NCT00385216|E2|Reported Event|Placebo|Sterile saline nasal spray was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489549|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489550|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489551|NCT00385580|O2|Outcome|Dasatinib 100 mg or 70 mg Twice Daily (BID)|Participants were administered an oral dose of 100 mg dasatinib tablet BID for a total daily dose (TDD) of 200 mg which was later decreased to 70 mg BID for a TDD of 140 mg. Of the 47 treated participants in the BID group, 25 received 100 mg and 22 received 70 mg of dasatinib as their starting doses. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489552|NCT00385580|O1|Outcome|Dasatinib 100 mg Once Daily (QD)|Participants were administered an oral dose of 100 mg dasatinib tablet QD. Participants continued to receive the study drug as long as tolerated or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
489553|NCT00385580|E1|Reported Event|Dasatinib|All treated participants
489554|NCT00385541|B3|Baseline|Total|Total of all reporting groups
489555|NCT00385541|B2|Baseline|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489556|NCT00385541|B1|Baseline|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489557|NCT00385541|P2|Participant Flow|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489558|NCT00385541|P1|Participant Flow|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489559|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489560|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489561|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489562|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489563|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489564|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489565|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489566|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489567|NCT00385541|O2|Outcome|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489568|NCT00385541|O1|Outcome|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489569|NCT00385541|E2|Reported Event|Hydromorphone PCA|Patients receive hydromorphone via PCA at 0.2mg/dose, max 2mg/hr lockout 6 minutes
489570|NCT00385541|E1|Reported Event|Morphine PCA|Patients receive morphine 1mg/dose pca for postsurgical pain. Max 10mg/hr, lockout 6 minutes
489571|NCT00385515|B3|Baseline|Total|Total of all reporting groups
489572|NCT00385515|B2|Baseline|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
489573|NCT00385515|B1|Baseline|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
489574|NCT00385515|P2|Participant Flow|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
489575|NCT00385515|P1|Participant Flow|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
489576|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
489577|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
489578|NCT00385515|O2|Outcome|Placebo|Placebo tablets (matched to SNX-1012) dissolved in water for oral swish and expectorate; 4 times daily for 10 days
489579|NCT00385515|O1|Outcome|SNX-1012|SNX-1012 (meclocycline sulfosalicylate) tablets dissolved in water for oral swish and expectorate; 30 mg, 4 times daily for 10 days
489580|NCT00385268|B3|Baseline|Total|Total of all reporting groups
489581|NCT00385268|B2|Baseline|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
489582|NCT00385268|B1|Baseline|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
489583|NCT00385268|P2|Participant Flow|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
489584|NCT00385268|P1|Participant Flow|Acamprosate|"1998mg/day for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~acamprosate : 1998 mg/dau fpr 8 weeks"
489585|NCT00385268|O2|Outcome|Placebo|"placebo pills for 8 weeks~Cognitive Behavioral Therapy : Weekly individual psychosocial treatment sessions.~placebo : placebo pills"
489601|NCT00385216|E1|Reported Event|Nicotine Nasal Spray|Nicotine nasal spray (3mg) was administered as 3 sprays to each nostril before surgery in either first intervention period or second intervention period.
489602|NCT00385203|B3|Baseline|Total|Total of all reporting groups
489603|NCT00385203|B2|Baseline|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day: 10 patients with Soft Tissue Sarcomas (STS) randomised
489604|NCT00385203|B1|Baseline|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day: 25 patients with Gastrointestinal Stromal Tumour (GIST) randomised
489605|NCT00385203|P2|Participant Flow|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489606|NCT00385203|P1|Participant Flow|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489607|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489608|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489609|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489610|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489611|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489612|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489613|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489614|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489615|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489616|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489617|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|10 Soft Tissue Sarcomas (STS) patients were randomised.
489618|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489619|NCT00385203|O2|Outcome|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment
489620|NCT00385203|O1|Outcome|Cediranib 45 mg/Day GIST|26 Gastrointestinal Stromal tumour patients (GIST) were enrolled (informed consent received), one patient was enrolled but had an AE prior to randomisation so were withdrawn from the study. No demographic data were obtained for this patient.
489621|NCT00385203|E2|Reported Event|Cediranib 45 mg/Day STS|Cediranib 45 mg/Day patients with Soft Tissue Sarcomas (STS): 10 patients randomised and received at least one dose of treatment.
489622|NCT00385203|E1|Reported Event|Cediranib 45 mg/Day GIST|Cediranib 45 mg/Day patients with Gastrointestinal Stromal Tumour (GIST): 24 patients randomised and received at least one dose of treatment (1 patient was not randomised or dosed and a further 1 patient was randomised but not dosed due to Incorrect enrolmentCediranib)
489623|NCT00385138|B3|Baseline|Total|Total of all reporting groups
489624|NCT00385138|B2|Baseline|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489625|NCT00385138|B1|Baseline|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489626|NCT00385138|P2|Participant Flow|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489627|NCT00385138|P1|Participant Flow|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489628|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489629|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489630|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489631|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489632|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489741|NCT00384930|E4|Reported Event|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489633|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489634|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489635|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489636|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489637|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489638|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489639|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489640|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489641|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489642|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489643|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489644|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489645|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489646|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489647|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489648|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489649|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489650|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489651|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489652|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489653|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489654|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489655|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489656|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489657|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489658|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489659|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489660|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489661|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489662|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489663|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489664|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489665|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489666|NCT00385138|O2|Outcome|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489667|NCT00385138|O1|Outcome|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489668|NCT00385138|E2|Reported Event|Clopidogrel|placebo bolus & infusion (to match) + clopidogrel capsules (600 mg) at end of PCI + placebo capsules (to match) immediately post infusion
489669|NCT00385138|E1|Reported Event|Cangrelor|cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + placebo capsules (to match) at end of PCI + active clopidogrel (600mg) immediately post infusion
489670|NCT00384956|B1|Baseline|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489671|NCT00384956|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489672|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489673|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489674|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489675|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489676|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489677|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489678|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489679|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489680|NCT00384956|O1|Outcome|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489681|NCT00384956|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m2 IV on days 1-5 of each 28 day cycle. Patients that do not respond after two cycles will have the dose increased to 100 mg/m2. Patients who achieve a CR will receive 3 additional 28 day cycles and then begin treatment on days 1-5 of a 56 day cycle. Individuals who demonstrate a loss of response will resume 28 day cycles.
489682|NCT00384930|B6|Baseline|Total|Total of all reporting groups
489683|NCT00384930|B5|Baseline|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489684|NCT00384930|B4|Baseline|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489685|NCT00384930|B3|Baseline|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489686|NCT00384930|B2|Baseline|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489687|NCT00384930|B1|Baseline|Placebo|placebo tablet by mouth once a day for twelve weeks
489688|NCT00384930|P5|Participant Flow|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489689|NCT00384930|P4|Participant Flow|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489690|NCT00384930|P3|Participant Flow|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489691|NCT00384930|P2|Participant Flow|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489692|NCT00384930|P1|Participant Flow|Placebo|placebo tablet by mouth once a day for twelve weeks
489693|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489694|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489695|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489696|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489697|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489698|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489699|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489700|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489701|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489702|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489703|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489704|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489705|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489706|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489707|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489708|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489709|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489710|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489711|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489712|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489713|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489714|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489715|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489716|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489717|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489718|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489719|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489720|NCT00384930|O3|Outcome|5.0 mg Tadalafil|5.0 mg tadalafil tablet by mouth once a day for twelve weeks
489721|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489722|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489723|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489724|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489725|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489726|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489727|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489728|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489729|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489730|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489731|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489732|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489733|NCT00384930|O5|Outcome|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489734|NCT00384930|O4|Outcome|10 mg Tadalafil|10 mg tadalafil tablet by mouth once a day for twelve weeks
489735|NCT00384930|O3|Outcome|5 mg Tadalafil|5 mg tadalafil tablet by mouth once a day for twelve weeks
489736|NCT00384930|O2|Outcome|2.5 mg Tadalafil|2.5 mg tadalafil tablet by mouth once a day for twelve weeks
489737|NCT00384930|O1|Outcome|Placebo|placebo tablet by mouth once a day for twelve weeks
489738|NCT00384930|O2|Outcome|5 mg Tadalafil|5 mg tadalafil tablet taken by mouth once a day for 12 weeks
489739|NCT00384930|O1|Outcome|Placebo|placebo tablet taken by mouth once a day for 12 weeks
489740|NCT00384930|E5|Reported Event|20 mg Tadalafil|20 mg tadalafil tablet by mouth once a day for twelve weeks
489746|NCT00384813|B2|Baseline|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
489747|NCT00384813|B1|Baseline|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
489748|NCT00384813|P2|Participant Flow|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
489749|NCT00384813|P1|Participant Flow|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
489750|NCT00384813|O2|Outcome|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
489751|NCT00384813|O1|Outcome|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
489752|NCT00384813|E2|Reported Event|2: Enhanced Treatment As Usual|"Enhanced Treatment As Usual (1 home visit)~Project ASPIRE Enhanced Treatment As Usual : Psychoeducational family intervention addressing the written asthma action plan during a single home visit, conducted by a respiratory therapist"
489753|NCT00384813|E1|Reported Event|1: Home-based Family Intervention|"Home-based family intervention~Project ASPIRE Home-Based Family Intervention : Home-based psychoeducational family intervention jointly conducted by psychology postdoctoral fellow and respiratory therapist over 4 months"
489754|NCT00384748|B3|Baseline|Total|Total of all reporting groups
489755|NCT00384748|B2|Baseline|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
489756|NCT00384748|B1|Baseline|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
489757|NCT00384748|P2|Participant Flow|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
489758|NCT00384748|P1|Participant Flow|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
489759|NCT00384748|O2|Outcome|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
489783|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489784|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489760|NCT00384748|O1|Outcome|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
489761|NCT00384748|E2|Reported Event|Arm 2|"Patients randomized to the Usual Care group receive routine VA care, as directed by their physicians.~Receipt of therapy services will be tracked via a weekly diary for the entire 6 months of the intervention period. In this weekly diary, patients in both the usual care and intervention group will record receipt of therapy. The patients will be asked to include the time in minutes that they spent in receipt of therapy services. Both groups will also be asked whether or not they exercised, and if so how frequently. TR and Usual Care participants will be administered telephone interviews at baseline, 3-and 6-months. The interview outcome measures are FONEFIM, Late-Life Function and Disability Instrument, Falls Self Efficacy Scale and Stroke Specific Patient Satisfaction with Care. In addition, sociodemographics, stroke severity, length of time since stroke onset, and depression at baseline will be measured.~Usual care: Routine VA care."
489762|NCT00384748|E1|Reported Event|Arm 1|"TR intervention consists of two parts 1) exercise targeting underlying stroke-related impairment and 2) adaptive strategies to help compensate for disability. An in-home messaging device is used to facilitate adherence with treatment recommendations and to screen for problems. This will allow targeted evaluations of problem areas during tele-visits, rapid response to new functional problems.~The 3 tele-visits will occur within 5 weeks post randomization. Telephone call visits will occur during even weeks.The first visit is devoted to mobility assessment, goal-setting. The second visit is to review the current exercise component. In-home messaging device. The teletherapist receives the clinical data from the in-home messaging device on a daily basis to screen for depression, lower extremity strength, self-care tasks and mobility, falls and exercise adherence."
489763|NCT00384670|B1|Baseline|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489764|NCT00384670|P1|Participant Flow|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489765|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489766|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489767|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489768|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489769|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489770|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489771|NCT00384670|O1|Outcome|Dengue and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489772|NCT00384670|E1|Reported Event|Dengue Vaccine and Japanese Encephalitis Vaccine|1 mL subcutaneous injection Dengue Vaccine Formulation 17 on Day 0 and Day 60. 0.5 mL subcutaneous injection Licensed Japanese Encephalitis (JE) Vaccine on months 7 and 7.5.
489773|NCT00384397|B4|Baseline|Total|Total of all reporting groups
489774|NCT00384397|B3|Baseline|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489775|NCT00384397|B2|Baseline|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489776|NCT00384397|B1|Baseline|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489777|NCT00384397|P3|Participant Flow|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489778|NCT00384397|P2|Participant Flow|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489779|NCT00384397|P1|Participant Flow|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489780|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489781|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489782|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
490538|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
489785|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489786|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489787|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489788|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489789|NCT00384397|O3|Outcome|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489790|NCT00384397|O2|Outcome|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489791|NCT00384397|O1|Outcome|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489792|NCT00384397|E3|Reported Event|Group 3: Menactra® + PCV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with pneumococcal conjugate vaccine (PCV) at age 12 months.
489793|NCT00384397|E2|Reported Event|Group 2: Menactra® + MMRV|Participants received one dose of Menactra® at age 9 months and a second dose of Menactra® concomitantly with measles-mumps-rubella-varicella (MMRV) vaccine at age 12 months.
489794|NCT00384397|E1|Reported Event|Group 1: Menactra® Vaccine|Participants received one dose of Menactra® alone at age 9 months and a second dose of Menactra® at age 12 months.
489795|NCT00384293|B3|Baseline|Total|Total of all reporting groups
489796|NCT00384293|B2|Baseline|Placebo (Postrandomization Period)|Patients who were randomized to placebo
489797|NCT00384293|B1|Baseline|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
489798|NCT00384293|P3|Participant Flow|Placebo (Postrandomization Period)|Patients who were randomized to placebo
489799|NCT00384293|P2|Participant Flow|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
489800|NCT00384293|P1|Participant Flow|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
489801|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
489802|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
489803|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
489804|NCT00384293|O3|Outcome|Placebo (Postrandomization Period)|Patients who were randomized to placebo
489805|NCT00384293|O2|Outcome|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
489806|NCT00384293|O1|Outcome|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
489807|NCT00384293|E3|Reported Event|Placebo (Postrandomization Period)|Patients who were randomized to placebo
489808|NCT00384293|E2|Reported Event|MK0524A, 2 g (Postrandomization Period)|Patients who were randomized to MK0524A, 2 g (oral administration) once daily.
489809|NCT00384293|E1|Reported Event|MK0524A Active Run-In Period|Patients who received MK0524A during active run-in (Visit 2). Per protocol, patients were scheduled to receive MK0524A 1g orally once daily for 4 weeks. The MK0524A dose was then increased to 2g (2x 1g tablets), once daily, at Visit 3 for an additional 4 weeks prior to randomization.
489810|NCT00383565|B1|Baseline|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489811|NCT00383565|P1|Participant Flow|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489812|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489813|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489814|NCT00383565|O1|Outcome|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489815|NCT00383565|E1|Reported Event|FR901228|13 mg/m^2 FR901228 by vein (IV) over 4 hours on days 1, 8, and 15
489816|NCT00383552|B5|Baseline|Total|Total of all reporting groups
489817|NCT00383552|B4|Baseline|Placebo BID|Placebo twice daily (BID)
489818|NCT00383552|B3|Baseline|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489819|NCT00383552|B2|Baseline|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489820|NCT00383552|B1|Baseline|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489821|NCT00383552|P4|Participant Flow|Placebo BID|Placebo twice daily (BID)
489822|NCT00383552|P3|Participant Flow|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489823|NCT00383552|P2|Participant Flow|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489824|NCT00383552|P1|Participant Flow|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489825|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489826|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489827|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489830|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489831|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489832|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489833|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489834|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489835|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489836|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489837|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489838|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489839|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489840|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489841|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489842|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489843|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489844|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489845|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID).
489846|NCT00383552|O3|Outcome|F MDI 10 Mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID).
489847|NCT00383552|O2|Outcome|MF MDI 100 Mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID).
489848|NCT00383552|O1|Outcome|MF/F MDI 100/10 Mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID).
489849|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489850|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489851|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489852|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489853|NCT00383552|O4|Outcome|Placebo BID|Placebo twice daily (BID)
489854|NCT00383552|O3|Outcome|F MDI 10 mcg BID|Formoterol Fumarate (F) metered dose inhaler (MDI) 10 mcg twice daily (BID)
489855|NCT00383552|O2|Outcome|MF MDI 100 mcg BID|Mometasone Furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID)
489856|NCT00383552|O1|Outcome|MF/F MDI 100/10 mcg BID|Mometasone Furoate/Formoterol Fumarate (MF/F) metered dose inhaler (MDI) 100/10 mcg twice daily (BID)
489857|NCT00383552|E5|Reported Event|PLACEBO|
489858|NCT00383552|E4|Reported Event|F MDI 10 MCG BID|
489859|NCT00383552|E3|Reported Event|MF MDI 100 MCG BID|
489860|NCT00383552|E2|Reported Event|MF/F MDI 100/10 MCG BID|
489861|NCT00383552|E1|Reported Event|OL MF MDI 100 MCG BID|Open-label (OL) mometasone furoate (MF) metered dose inhaler (MDI) 100 mcg twice daily (BID). Participants received 2- to 3-weeks (approximately) of open-label run-in with MF MDI 100 mcg BID prior to the 26-week double-blind Treatment Period.
489862|NCT00384241|B3|Baseline|Total|Total of all reporting groups
489863|NCT00384241|B2|Baseline|Parents|African American and Caucasian parents, age 18-65.
489864|NCT00384241|B1|Baseline|Children|African American and Caucasian children age 15-19.
489865|NCT00384241|P2|Participant Flow|Parents|Buccal swabs from the Parents of 500 subjects in the children arm were collected and analyzed for genetic variations. Some parents submitted duplicate swabs if more than 1 child was represented in the 500 subjects.
489866|NCT00384241|P1|Participant Flow|Children|Genotyping and IL-6 levels of 500 children enrolled in two previous studies were collected in the current study. Other phenotype data: Baseline blood pressure, stress blood pressure, and recovery blood pressure; Baseline stress and recovery urinary sodium excretion that were collected in two previous studies were utilized in the current study.
489867|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
489868|NCT00384241|O1|Outcome|Children|500 children age 15-19, self reported as African American or of European origin, healthy, non-smoker with normal blood pressure that participated in two previous studies
489869|NCT00384241|E2|Reported Event|Parents|African American and Caucasian parents age 18 - 65
489870|NCT00384241|E1|Reported Event|Children|African American and Caucasian children age 15 - 19.
489871|NCT00384189|B5|Baseline|Total|Total of all reporting groups
489872|NCT00384189|B4|Baseline|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489873|NCT00384189|B3|Baseline|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489874|NCT00384189|B2|Baseline|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
490036|NCT00384059|E6|Reported Event|7vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489875|NCT00384189|B1|Baseline|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489876|NCT00384189|P4|Participant Flow|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489877|NCT00384189|P3|Participant Flow|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489878|NCT00384189|P2|Participant Flow|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489879|NCT00384189|P1|Participant Flow|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489880|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489881|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489882|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489883|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489884|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489885|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489886|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489887|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489888|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489889|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489890|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489891|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489892|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
490124|NCT00383721|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
489893|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489894|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489895|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489896|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489897|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489898|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489899|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489900|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489901|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489902|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489903|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489904|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489905|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489906|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489907|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489908|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489909|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489910|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
490037|NCT00384059|E5|Reported Event|13vPnC Toddler Series|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489911|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489912|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489913|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489914|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489915|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489916|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489917|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489918|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489919|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489920|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489921|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489922|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489923|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489924|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489925|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489926|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489927|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489928|NCT00384189|O4|Outcome|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
490121|NCT00383721|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490125|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
489929|NCT00384189|O3|Outcome|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489930|NCT00384189|O2|Outcome|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489931|NCT00384189|O1|Outcome|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489932|NCT00384189|E4|Reported Event|Placebo|Placebo-matching Ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 2 to 4 week in the Baseline period followed by placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489933|NCT00384189|E3|Reported Event|Ciclesonide 160 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 160 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489934|NCT00384189|E2|Reported Event|Ciclesonide 80 µg|Placebo-matching ciclesonide, inhaled via a MDI with HFA-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 80 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489935|NCT00384189|E1|Reported Event|Ciclesonide 40 µg|Placebo-matching ciclesonide, inhaled via a metered-dose inhaler (MDI) with 1,1,1,2-hydrofluoroalkane (HFA)-134a as propellant, once daily, in the evening for 2 to 4 weeks in the Baseline period followed by ciclesonide 40 µg, inhaled via a MDI with HFA-134a as propellant, once daily in the evening for 12 weeks. Salbutamol 100 μg/puff was available to be used as rescue medication if needed.
489936|NCT00384176|B4|Baseline|Total|Total of all reporting groups
489937|NCT00384176|B3|Baseline|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489938|NCT00384176|B2|Baseline|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489939|NCT00384176|B1|Baseline|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489940|NCT00384176|P3|Participant Flow|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489941|NCT00384176|P2|Participant Flow|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489942|NCT00384176|P1|Participant Flow|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489943|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489944|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489945|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
490122|NCT00383721|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
489946|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489947|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489948|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489949|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489950|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489951|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489952|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489953|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489954|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489955|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489956|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489957|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489958|NCT00384176|O3|Outcome|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489959|NCT00384176|O2|Outcome|Bevacizumab 5 mg/kg|"Bevacizumab 5 mg/kg on Day 1 and every 2 weeks~+ FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489960|NCT00384176|O1|Outcome|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489961|NCT00384176|E3|Reported Event|1Bevacizumab 5mg/kg|Bevacizumab 5 mg/kg on Day 1 and every 2 weeks
490123|NCT00383721|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
489962|NCT00384176|E2|Reported Event|Cediranib 30 mg|"Cediranib 30 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489963|NCT00384176|E1|Reported Event|Cediranib 20 mg|"Cediranib 20 mg/day + FOLFOX~The FOLFOX regimen in this study was a modified FOLFOX6 regimen, repeated every 2 weeks:~Oxaliplatin 85 mg/m2 with leucovorin 400 mg/m2 (or equivalent folinic acid preparation) administered intravenously over 2 hours on Day 1~5-FU 400 mg/m2 bolus immediately after completion of the oxaliplatin infusion on Day 1, followed immediately by 5-FU 2400 mg/m2 administered by a continuous iv infusion over 46 hours."
489964|NCT00384085|B4|Baseline|Total|Total of all reporting groups
489965|NCT00384085|B3|Baseline|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489966|NCT00384085|B2|Baseline|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489967|NCT00384085|B1|Baseline|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489968|NCT00384085|P3|Participant Flow|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489969|NCT00384085|P2|Participant Flow|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489970|NCT00384085|P1|Participant Flow|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489971|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489972|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489973|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489974|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489975|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489976|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489977|NCT00384085|O3|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489978|NCT00384085|O2|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489979|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489980|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489981|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489982|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489983|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489984|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489985|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489986|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489987|NCT00384085|O1|Outcome|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489988|NCT00384085|O2|Outcome|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489989|NCT00384085|O1|Outcome|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489990|NCT00384085|E3|Reported Event|Novolog Mix 70/30|Premixed insulin (Novolog® Mix 70/30) added to oral agents.
489991|NCT00384085|E2|Reported Event|Lantus/Apidra-1|Insulin glargine (Lantus) plus up to 1 injection of insulin glulisine (Apidra) added to oral agents.
489992|NCT00384085|E1|Reported Event|Lantus/Apidra-3|Insulin glargine (Lantus) plus up to 3 injections of insulin glulisine (Apidra) added to oral agents.
489993|NCT00384059|B3|Baseline|Total|Total of all reporting groups
489994|NCT00384059|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489995|NCT00384059|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489996|NCT00384059|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490126|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
489997|NCT00384059|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489998|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
489999|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490000|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
490001|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
490002|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
490003|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
490004|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
490005|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
490006|NCT00384059|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Menitorix at 12 months of age.
490007|NCT00384059|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Menitorix at 12 months of age.
490008|NCT00384059|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
490009|NCT00384059|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 4 months of age.
490010|NCT00384059|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
490011|NCT00384059|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C and Pediacel at 2 months of age.
490012|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
490013|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
490014|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits, and Menitorix at the 12-month visit.
490015|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
490016|NCT00384059|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
490017|NCT00384059|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
490018|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490019|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490020|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490021|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490022|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490023|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490024|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490025|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490026|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490027|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490028|NCT00384059|O4|Outcome|7vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
490029|NCT00384059|O3|Outcome|13vPnC After Toddler Dose|Participants received Menitorix at the 12-month visit.
490030|NCT00384059|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
490031|NCT00384059|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with NeisVac-C at the 2- and 4-month visits, Pediacel at the 2-, 3-, and 4-month visits.
490032|NCT00384059|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490033|NCT00384059|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (infant series). Pediacel was administered without study vaccine at 3-month visit. Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit (toddler dose).
490034|NCT00384059|E8|Reported Event|7vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 7vPnC coadministered with Haemophilus Influenzae Type b (Hib) and Meningococcal C Vaccine (Menitorix) at the 12-month visit(assessment at 18 months of age, 6 months after the toddler dose).
490035|NCT00384059|E7|Reported Event|13vPnC 6-Month Follow-up|Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Haemophilus Influenzae Type b (Hib) & Meningococcal C Vaccine (Menitorix) at the 12-month visit (assessment at 18 months of age, 6 months after the toddler dose).
490239|NCT00383240|P4|Participant Flow|Placebo BID|Placebo MDI BID for 26 weeks
490038|NCT00384059|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
490039|NCT00384059|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits (assessment at 5 months of age, 1 month after the infant series). Pediacel was administered without study vaccine at 3-month visit.
490040|NCT00384059|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
490041|NCT00384059|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with meningococcal C-tetanus toxoid conjugate vaccine (NeisVac-C) and a combined diphtheria, tetanus, five component acellular pertussis (DT5aP), inactivated poliomyelitis (IPV) and haemophilus influenzae type b (Hib) conjugate vaccine (Pediacel) at the 2- and 4-month visits. Pediacel was administered without study vaccine at 3-month visit.
490042|NCT00384033|B5|Baseline|Total|Total of all reporting groups
490043|NCT00384033|B4|Baseline|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490044|NCT00384033|B3|Baseline|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490045|NCT00384033|B2|Baseline|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490046|NCT00384033|B1|Baseline|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490047|NCT00384033|P4|Participant Flow|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490048|NCT00384033|P3|Participant Flow|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490049|NCT00384033|P2|Participant Flow|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490050|NCT00384033|P1|Participant Flow|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490051|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490052|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490053|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490054|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490055|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490056|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490057|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490539|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490058|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490059|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490060|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490061|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490062|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490063|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490064|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490065|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490066|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490067|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490068|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490069|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490070|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490071|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490072|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490073|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490074|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490075|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490076|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490077|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490078|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490079|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490080|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490081|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490082|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490083|NCT00384033|O4|Outcome|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490084|NCT00384033|O3|Outcome|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490085|NCT00384033|O2|Outcome|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490086|NCT00384033|O1|Outcome|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490087|NCT00384033|E4|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg capsule and placebo matched to DVS SR 50 mg and DVS SR 100 mg tablet daily until Day 56 (Week 8) or ET; then duloxetine 30 mg capsule and placebo matched to DVS SR 50 mg and 100 mg tablet for days 57-63 (Taper week).
490088|NCT00384033|E3|Reported Event|DVS SR 100 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily for days 1-7; then DVS titrated up to 100 mg tablet, placebo matched to DVS SR 50 mg and duloxetine 60 mg capsule daily from days 8-56 (Week 8) or ET; then tapered to DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490089|NCT00384033|E2|Reported Event|DVS SR 50 mg|DVS SR 50 mg tablet and placebo matched to DVS SR 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or ET; then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490090|NCT00384033|E1|Reported Event|Placebo|Placebo matched to desvenlafaxine succinate monohydrate sustained release (DVS SR) 50 milligram (mg) and 100 mg tablet and duloxetine 60 mg capsule daily until Day 56 (Week 8) or early termination (ET); then placebo matched to DVS SR 50 mg and 100 mg tablet and duloxetine 30 mg capsule for days 57-63 (Taper week).
490091|NCT00383786|B3|Baseline|Total|Total of all reporting groups
490092|NCT00383786|B2|Baseline|Placebo|sugar pill
490093|NCT00383786|B1|Baseline|GR205171|selective neurokinin-1 receptor antagonist
490094|NCT00383786|P2|Participant Flow|Placebo|sugar pill administered daily for a period of 8 weeks
490095|NCT00383786|P1|Participant Flow|GR205171|selective neurokinin-1 receptor antagonist, 5mg/day for a period of 8 weeks
490096|NCT00383786|O2|Outcome|Placebo|
490097|NCT00383786|O1|Outcome|GR205171|
490098|NCT00383786|E2|Reported Event|Placebo|sugar pill
490099|NCT00383786|E1|Reported Event|GR205171|selective neurokinin-1 receptor antagonist
490100|NCT00383760|B1|Baseline|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: 1.4mg/m2 given IV weekly day 1,8 every 21 days (1 cycle)."
490101|NCT00383760|P1|Participant Flow|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490102|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490103|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490104|NCT00383760|O1|Outcome|E7389|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490105|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490106|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490107|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490108|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490109|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490110|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490111|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490112|NCT00383760|O1|Outcome|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490113|NCT00383760|E1|Reported Event|Treatment (Eribulin Mesylate)|"Patients receive E7389 IV on days 1 and 8.~eribulin mesylate: Given IV"
490114|NCT00383721|B6|Baseline|Total|Total of all reporting groups
490115|NCT00383721|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks.
490116|NCT00383721|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490117|NCT00383721|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490118|NCT00383721|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490119|NCT00383721|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490120|NCT00383721|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks.
490127|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490128|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490129|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490130|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
490131|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490132|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490133|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490134|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490135|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
490136|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490137|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490138|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490139|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490140|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
490141|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490142|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490143|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490144|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490145|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
490146|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490147|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490148|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490149|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490150|NCT00383721|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks.
490151|NCT00383721|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490152|NCT00383721|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490153|NCT00383721|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490154|NCT00383721|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490155|NCT00383721|E5|Reported Event|Placebo|Placebo MDI BID for 26 weeks.
490156|NCT00383721|E4|Reported Event|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks.
490157|NCT00383721|E3|Reported Event|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks.
490158|NCT00383721|E2|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks.
490159|NCT00383721|E1|Reported Event|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks.
490160|NCT00383435|B6|Baseline|Total|Total of all reporting groups
490161|NCT00383435|B5|Baseline|Placebo|Placebo MDI BID for 26 weeks
490162|NCT00383435|B4|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490163|NCT00383435|B3|Baseline|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490164|NCT00383435|B2|Baseline|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490165|NCT00383435|B1|Baseline|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490166|NCT00383435|P5|Participant Flow|Placebo|Placebo MDI BID for 26 weeks
490167|NCT00383435|P4|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490168|NCT00383435|P3|Participant Flow|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490169|NCT00383435|P2|Participant Flow|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490170|NCT00383435|P1|Participant Flow|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490171|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490172|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490173|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490174|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490175|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490176|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490177|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490178|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490179|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490180|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490181|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490182|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490183|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490184|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490185|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490186|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490187|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490188|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490189|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490190|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490191|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490192|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490193|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490194|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490195|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490196|NCT00383435|O5|Outcome|Placebo|Placebo MDI BID for 26 weeks
490197|NCT00383435|O4|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) 10 mcg via a MDI BID for 52 weeks
490198|NCT00383435|O3|Outcome|MF MDI 400 mcg BID|Mometasone furoate (MF) 400 mcg via a MDI BID for 52 weeks
490199|NCT00383435|O2|Outcome|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a MDI BID for 52 weeks
490200|NCT00383435|O1|Outcome|MF/F MDI 400/10 mcg BID|Mometasone furoate/formoterol fumarate (MF/F) 400/10 mcg via a metered dose inhaler (MDI) twice daily (BID) for 52 weeks
490201|NCT00383435|E5|Reported Event|PLACEBO|
490202|NCT00383435|E4|Reported Event|F MDI 10 MCG BID|
490203|NCT00383435|E3|Reported Event|MF MDI 400 MCG BID|
490204|NCT00383435|E2|Reported Event|MF/F MDI 400/10 MCG BID|
490205|NCT00383435|E1|Reported Event|MF/F MDI 200/10 MCG BID|
490206|NCT00383331|B3|Baseline|Total|Total of all reporting groups
490207|NCT00383331|B2|Baseline|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490208|NCT00383331|B1|Baseline|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490209|NCT00383331|P2|Participant Flow|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490210|NCT00383331|P1|Participant Flow|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490211|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490212|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490213|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490214|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490215|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490216|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490217|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490218|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490219|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490220|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490221|NCT00383331|O2|Outcome|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490222|NCT00383331|O1|Outcome|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490223|NCT00383331|E2|Reported Event|14-Day Cycle|Pemetrexed and Gemcitabine Day 1, every 14 days x 9 cycles
490224|NCT00383331|E1|Reported Event|21-Day Cycle|Pemetrexed and Gemcitabine Day 1 followed by Gemcitabine Day 8, every 21 days x 6 cycles
490225|NCT00383266|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490226|NCT00383266|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490227|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490228|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490229|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490230|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490231|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490232|NCT00383266|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490233|NCT00383266|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed 500 mg/m^2 IV over 10 minutes~Carboplatin AUC 5 IV over 30 minutes on day 1 of each cycle~Each cycle will last 21 days."
490234|NCT00383240|B5|Baseline|Total|Total of all reporting groups
490235|NCT00383240|B4|Baseline|Placebo BID|Placebo MDI BID for 26 weeks
490236|NCT00383240|B3|Baseline|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490237|NCT00383240|B2|Baseline|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490238|NCT00383240|B1|Baseline|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490240|NCT00383240|P3|Participant Flow|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490241|NCT00383240|P2|Participant Flow|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490242|NCT00383240|P1|Participant Flow|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490243|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490244|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490245|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490246|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490247|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490248|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490249|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490250|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490251|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490252|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490253|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490254|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490255|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490256|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490257|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490258|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490259|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490260|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490261|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490262|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490263|NCT00383240|O4|Outcome|Placebo BID|Placebo MDI BID for 26 weeks
490264|NCT00383240|O3|Outcome|F MDI 10 mcg BID|Formoterol fumarate (F) MDI 10 mcg BID for 26 weeks
490265|NCT00383240|O2|Outcome|MF MDI 200 mcg BID|Mometasone furoate (MF) MDI 200 mcg BID for 26 weeks
490266|NCT00383240|O1|Outcome|MF/F MDI 200/10 mcg BID|mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 200/10 mcg twice daily (BID) for 26 weeks
490267|NCT00383240|E5|Reported Event|PLACEBO|
490268|NCT00383240|E4|Reported Event|F MDI 10 MCG BID|
490269|NCT00383240|E3|Reported Event|MF MDI 200 MCG BID|
490270|NCT00383240|E2|Reported Event|MF/F MDI 200/10 MCG BID|
490271|NCT00383240|E1|Reported Event|OL MF MDI 200 MCG BID|Participants received 2 to 3 weeks (approximately) of open-label (OL), run-in medication with MF MDI 200 mcg BID prior to the 26-week double-blind treatment period.
490272|NCT00383162|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
490273|NCT00383162|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
490274|NCT00383162|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
490275|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490276|NCT00383162|O1|Outcome|Placebo|
490277|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490278|NCT00383162|O1|Outcome|Placebo|
490279|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490280|NCT00383162|O1|Outcome|Placebo|
490281|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490282|NCT00383162|O1|Outcome|Placebo|
490283|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490284|NCT00383162|O1|Outcome|Placebo|
490285|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490286|NCT00383162|O1|Outcome|Placebo|
490287|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490288|NCT00383162|O1|Outcome|Placebo|
490289|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490290|NCT00383162|O1|Outcome|Placebo|
490291|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490292|NCT00383162|O1|Outcome|Placebo|
490293|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490294|NCT00383162|O1|Outcome|Placebo|
490295|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490296|NCT00383162|O1|Outcome|Placebo|
490297|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490298|NCT00383162|O1|Outcome|Placebo|
490299|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490300|NCT00383162|O1|Outcome|Placebo|
490301|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490302|NCT00383162|O1|Outcome|Placebo|
490303|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490304|NCT00383162|O1|Outcome|Placebo|
490305|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490306|NCT00383162|O1|Outcome|Placebo|
490307|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490308|NCT00383162|O1|Outcome|Placebo|
490309|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490310|NCT00383162|O1|Outcome|Placebo|
490311|NCT00383162|O2|Outcome|Sumatriptan-Naproxen Sodium|
490312|NCT00383162|O1|Outcome|Placebo|
490540|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490313|NCT00383162|E2|Reported Event|Sumatriptan-Naproxen Sodium|Subjects who were randomized to take Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 1, then a one week wash-out period without any drugs, and then given Placebo during Migraine period 2.
490314|NCT00383162|E1|Reported Event|Placebo|Subjects who were randomized to take Placebo during Migraine period 1, then a one week wash-out period without any drugs, and then given Sumatriptan 85 mg/Naproxen Sodium 500 mg during Migraine period 2.
490315|NCT00383149|B1|Baseline|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490316|NCT00383149|P1|Participant Flow|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490317|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490318|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490319|NCT00383149|O2|Outcome|Cetuximab|All participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490320|NCT00383149|O1|Outcome|Ixabepilone|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks.
490321|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490322|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490323|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490324|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490325|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490326|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490327|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490328|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490329|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490330|NCT00383149|O1|Outcome|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490331|NCT00383149|E1|Reported Event|Ixabepilone + Cetuximab|All participants were administered ixabepilone at a starting dose of 32 mg/m^2 as a 3-hour intravenous (IV) infusion every 3 weeks. In addition, all participants were administered an initial dose of cetuximab (400 mg/m^2 IV over 2 hours) followed by a weekly lower dose (250 mg/m^2 IV over 1 hour).
490332|NCT00383123|B3|Baseline|Total|Total of all reporting groups
490333|NCT00383123|B2|Baseline|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490334|NCT00383123|B1|Baseline|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490335|NCT00383123|P2|Participant Flow|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490336|NCT00383123|P1|Participant Flow|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490414|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490337|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490338|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490339|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490340|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490341|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490342|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490343|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490344|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490345|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490346|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490347|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490348|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490349|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490350|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490351|NCT00383123|O2|Outcome|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490352|NCT00383123|O1|Outcome|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490353|NCT00383123|E2|Reported Event|Fluzone Group|"Subjects in this group received Fluzone and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490354|NCT00383123|E1|Reported Event|Fluarix Group|"Subjects in this group received Fluarix™ and will be further stratified by 3 age groups~1:1 in 6 months to < 36 months~1:1 in 3 to < 5 years~3:1 in 5 to < 18 years"
490355|NCT00383110|B3|Baseline|Total|Total of all reporting groups
490356|NCT00383110|B2|Baseline|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
490357|NCT00383110|B1|Baseline|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490358|NCT00383110|P2|Participant Flow|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
490359|NCT00383110|P1|Participant Flow|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490360|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490361|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490362|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490363|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490364|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490365|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490366|NCT00383110|O2|Outcome|Black American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490367|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490368|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
490369|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490370|NCT00383110|O2|Outcome|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
490371|NCT00383110|O1|Outcome|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490372|NCT00383110|E2|Reported Event|Black American Veterans|Black American adult Veterans (age 18 or older) with type 2 diabetes
490373|NCT00383110|E1|Reported Event|White American Veterans|White American adult Veterans (age 18 or older) with type 2 diabetes
490374|NCT00383084|B3|Baseline|Total|Total of all reporting groups
490375|NCT00383084|B2|Baseline|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490376|NCT00383084|B1|Baseline|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490541|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490377|NCT00383084|P2|Participant Flow|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490378|NCT00383084|P1|Participant Flow|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490379|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490380|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490381|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490382|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490383|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490384|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490385|NCT00383084|O2|Outcome|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490386|NCT00383084|O1|Outcome|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490387|NCT00383084|E2|Reported Event|Education|Group 2 participants will attend monthly fibromyalgia educational sessions, which will focus on understanding the symptoms of FM, learning to manage pain and fatigue, and developing self-help strategies.
490388|NCT00383084|E1|Reported Event|Lifestyle Physical Activity|Group 1 participants will take part in 30 minutes total of self-selected lifestyle physical activity throughout the day, 5 to 7 days per week. Twice a month, they will attend group sessions designed to help participants develop and maintain a more physically active lifestyle. Goal setting, self-monitoring, and pain management will be discussed at these sessions.
490389|NCT00383071|B5|Baseline|Total|Total of all reporting groups
490390|NCT00383071|B4|Baseline|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
490391|NCT00383071|B3|Baseline|180 mcg Cohort 4|180 mcg IM every 4 weeks for 2 vaccinations
490392|NCT00383071|B2|Baseline|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
490393|NCT00383071|B1|Baseline|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
490394|NCT00383071|P4|Participant Flow|Cohort 1: 90 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
490395|NCT00383071|P3|Participant Flow|Cohort 4: 180 mcg|120 mcg every 28 days x 2 doses. Subjects randomized to receive vaccination in arm or buttock.
490396|NCT00383071|P2|Participant Flow|Cohort 3: 180 mcg|180 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
490397|NCT00383071|P1|Participant Flow|Cohort 2: 120 mcg|120 mcg every 28 days x 4 doses. Subjects chose vaccination in arm or buttock.
490398|NCT00383071|O4|Outcome|180 mcg Cohort 4|120 mcg IM every 4 weeks for 2 vaccinations
490399|NCT00383071|O3|Outcome|180 mcg|180 mcg IM every 4 weeks for 4 vaccinations
490400|NCT00383071|O2|Outcome|120 mcg|120 mcg IM every 4 weeks for 4 vaccinations
490401|NCT00383071|O1|Outcome|90 mcg|90 mcg IM every 4 weeks for 4 vaccinations
490402|NCT00383071|E4|Reported Event|90 mcg|90 mcg every 28 days x 4 doses
490403|NCT00383071|E3|Reported Event|180 mcg Cohort 4|180 mcg every 28 days x 2 doses
490404|NCT00383071|E2|Reported Event|180 mcg|180 mcg every 28 days x 4 doses
490405|NCT00383071|E1|Reported Event|120 mcg|120 mcg every 28 days x 4 doses
490406|NCT00383019|B3|Baseline|Total|Total of all reporting groups
490407|NCT00383019|B2|Baseline|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490408|NCT00383019|B1|Baseline|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490409|NCT00383019|P2|Participant Flow|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490410|NCT00383019|P1|Participant Flow|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490411|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490412|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490413|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490415|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490416|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490417|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490418|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490419|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490420|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490421|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490422|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490423|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490424|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490425|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490426|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490427|NCT00383019|O2|Outcome|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490428|NCT00383019|O1|Outcome|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490429|NCT00383019|E2|Reported Event|Xalatan Group|Subjects were treated with Xalatan (0.005% latanoprost), one drop, once daily in the evening (20:00-23:00).
490430|NCT00383019|E1|Reported Event|KP2035 Group|Subjects were treated with KP2035 (0.005% latanoprost + 0.5% timolol combination eye drop) one drop, once daily in the evening (20:00-23:00).
490431|NCT00382993|B1|Baseline|Safety Population|Safety Population – Participants who were randomized and who treated at least 1 migraine attack with investigational product.
490432|NCT00382993|P2|Participant Flow|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
490433|NCT00382993|P1|Participant Flow|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
490434|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490435|NCT00382993|O1|Outcome|Placebo|
490436|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490437|NCT00382993|O1|Outcome|Placebo|
490438|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490439|NCT00382993|O1|Outcome|Placebo|
490440|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490441|NCT00382993|O1|Outcome|Placebo|
490442|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490443|NCT00382993|O1|Outcome|Placebo|
490444|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490445|NCT00382993|O1|Outcome|Placebo|
490446|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490447|NCT00382993|O1|Outcome|Placebo|
490448|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490449|NCT00382993|O1|Outcome|Placebo|
490450|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490451|NCT00382993|O1|Outcome|Placebo|
490452|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490453|NCT00382993|O1|Outcome|Placebo|
490454|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490455|NCT00382993|O1|Outcome|Placebo|
490456|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490457|NCT00382993|O1|Outcome|Placebo|
490458|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490459|NCT00382993|O1|Outcome|Placebo|
490460|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490461|NCT00382993|O1|Outcome|Placebo|
490462|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490463|NCT00382993|O1|Outcome|Placebo|
490464|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490465|NCT00382993|O1|Outcome|Placebo|
490466|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490467|NCT00382993|O1|Outcome|Placebo|
490468|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490469|NCT00382993|O1|Outcome|Placebo|
490470|NCT00382993|O2|Outcome|Sumatriptan/Naproxen Sodium|
490471|NCT00382993|O1|Outcome|Placebo|
490472|NCT00382993|E2|Reported Event|Sumatriptan-Naproxen/Placebo|Participants who were randomized to treat the first of two migraine attacks with 85 mg/Naproxen Sodium 500 mg (period 1) and the second attack with Placebo (period 2).
490473|NCT00382993|E1|Reported Event|Placebo/Sumatriptan-Naproxen|Participants who were randomized to treat the first of two migraine attacks with Placebo (period 1) and the second attack with 85 mg/Naproxen Sodium 500 mg (period 2).
490474|NCT00382967|B3|Baseline|Total|Total of all reporting groups
490475|NCT00382967|B2|Baseline|Control Arm|No (Injection) Intervention
490476|NCT00382967|B1|Baseline|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
490477|NCT00382967|P2|Participant Flow|Control Arm|No (Injection) Intervention
490478|NCT00382967|P1|Participant Flow|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
490479|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
490629|NCT00382408|O2|Outcome|Placebo|Oral Type-7 placebo
490480|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
490481|NCT00382967|O2|Outcome|Control Arm|No (Injection) Intervention
490482|NCT00382967|O1|Outcome|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
490483|NCT00382967|E2|Reported Event|Control Arm|No (Injection) Intervention
490484|NCT00382967|E1|Reported Event|Datscan Product|[Iodine-123]Ioflupane isotonic solution. Single i.v. injection within the dose range of 111 to 185 Megabecquerel (MBq) [3-5 millicurie (mCi)].
490485|NCT00382928|B3|Baseline|Total|Total of all reporting groups
490486|NCT00382928|B2|Baseline|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490487|NCT00382928|B1|Baseline|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490488|NCT00382928|P2|Participant Flow|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490489|NCT00382928|P1|Participant Flow|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention
490490|NCT00382928|O2|Outcome|Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490491|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490492|NCT00382928|O2|Outcome|No Intervention: Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490493|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490494|NCT00382928|O2|Outcome|Standard of Care|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490495|NCT00382928|O1|Outcome|AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490496|NCT00382928|O2|Outcome|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490497|NCT00382928|O1|Outcome|Experimental: AECD Monitoring + Stand of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490498|NCT00382928|E2|Reported Event|No Intervention: Standard of Care Group|Patients will receive standard of care measures in case of cardiac arrest. They will not receive AECD monitoring or intervention.
490499|NCT00382928|E1|Reported Event|Experimental: AECD Monitoring + Standard of Care Group|Patients will receive AECD monitoring and intervention in addition to standard of care in case of cardiac arrest during admission to the hospital.
490500|NCT00382863|B3|Baseline|Total|Total of all reporting groups
490501|NCT00382863|B2|Baseline|Control|Optimal Medical/Device Therapy alone
490502|NCT00382863|B1|Baseline|Treatment|HeartNet and Optimal Medical/Device Therapy
490503|NCT00382863|P2|Participant Flow|Control|Optimal Medical/Device Therapy alone
490504|NCT00382863|P1|Participant Flow|Treatment|HeartNet and Optimal Medical/Device Therapy
490505|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490506|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490507|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490508|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490509|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490510|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490511|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490512|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490513|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490514|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490515|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490516|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490517|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490518|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490519|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490520|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490521|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490522|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490523|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490524|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490525|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490526|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490527|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490528|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490529|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490530|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490531|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490532|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490533|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490542|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490543|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490544|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490545|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490546|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490547|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490548|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490549|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490550|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490551|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490552|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490553|NCT00382863|O2|Outcome|Control|Optimal Medical/Device Therapy alone
490554|NCT00382863|O1|Outcome|Treatment|HeartNet and Optimal Medical/Device Therapy
490555|NCT00382863|E2|Reported Event|Control|Optimal Medical/Device Therapy alone
490556|NCT00382863|E1|Reported Event|Treatment|HeartNet and Optimal Medical/Device Therapy
490557|NCT00382785|B3|Baseline|Total|Total of all reporting groups
490558|NCT00382785|B2|Baseline|Non-facilitated (Peer-led)|12-week online support in a peer-led format
490559|NCT00382785|B1|Baseline|Moderated Group|one 12-week online support group led by a professional healthcare provider
490560|NCT00382785|P2|Participant Flow|Non-facilitated (Peer-led)|12-week online support in a peer-led format
490561|NCT00382785|P1|Participant Flow|Moderated Group|one 12-week online support group led by a professional healthcare provider
490562|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
490563|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
490564|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
490565|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
490566|NCT00382785|O2|Outcome|Non-facilitated (Peer-led)|12-week online support in a peer-led format
490567|NCT00382785|O1|Outcome|Moderated Group|one 12-week online support group led by a professional healthcare provider
490568|NCT00382785|E2|Reported Event|Peer-led|peer-led group
490569|NCT00382785|E1|Reported Event|Moderated|
490570|NCT00382733|B1|Baseline|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
490571|NCT00382733|P5|Participant Flow|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
490572|NCT00382733|P4|Participant Flow|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
490573|NCT00382733|P3|Participant Flow|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
490574|NCT00382733|P2|Participant Flow|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
490575|NCT00382733|P1|Participant Flow|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
490576|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
490577|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
490578|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
490579|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
490580|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
490581|NCT00382733|O5|Outcome|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
490582|NCT00382733|O4|Outcome|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
490583|NCT00382733|O3|Outcome|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
490584|NCT00382733|O2|Outcome|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
490585|NCT00382733|O1|Outcome|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
490586|NCT00382733|O1|Outcome|Metronomic Oral Topotecan|All subjects received metronomic oral topotecan daily at the assigned dose level.
490587|NCT00382733|E5|Reported Event|Oral Topotecan 1.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.25 mg daily (Dose Level 5).
490588|NCT00382733|E4|Reported Event|Oral Topotecan 1.0 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 1.0 mg daily (Dose Level 4).
490589|NCT00382733|E3|Reported Event|Oral Topotecan 0.75 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.75 mg daily (Dose Level 3).
490590|NCT00382733|E2|Reported Event|Oral Topotecan 0.50 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.50 mg daily (Dose Level 2).
490591|NCT00382733|E1|Reported Event|Oral Topotecan 0.25 mg Daily|All subjects in this group were assigned to receive metronomic oral topotecan 0.25 mg daily (Dose Level 1).
490592|NCT00382720|B4|Baseline|Total|Total of all reporting groups
490593|NCT00382720|B3|Baseline|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490594|NCT00382720|B2|Baseline|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490595|NCT00382720|B1|Baseline|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490596|NCT00382720|P3|Participant Flow|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490597|NCT00382720|P2|Participant Flow|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490598|NCT00382720|P1|Participant Flow|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490599|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490600|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490601|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490602|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490603|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490604|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490605|NCT00382720|O3|Outcome|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490606|NCT00382720|O2|Outcome|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490607|NCT00382720|O1|Outcome|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490608|NCT00382720|E3|Reported Event|(TEX) Taxotere, Eloxatin and Xeloda|Participants administered Docetaxel (Taxotere) 50 mg/m² as a 1-hour intravenous (IV) infusion on day 1, Oxaliplatin (Eloxatin) 100 mg/m² as a two to six-hour IV infusion on day 1, Capecitabine (Xeloda) 625 mg/m2 two times a day continuously per chemotherapy cycle.
490609|NCT00382720|E2|Reported Event|(TEF) Taxotere, Eloxatin and 5-fluorouracil|Participants administed with Docetaxel (Taxotere) 50 mg/m² as a 1-hour IV infusion day 1; Oxaliplatin (Eloxatin) 85 mg/m² simultaneously with folinic acid 400 mg/m² as a 2-hour IV infusion, followed by 5-FU 2400 mg/m² as a 46-hour continuous infusion day 1 per chemotherapy cycle.
490610|NCT00382720|E1|Reported Event|(TE) Taxotere and Eloxatin|Participants administered Docetaxel (Taxotere) 75 mg/m² as an 1-hour IV infusion on day 1 followed by Oxaliplatin (Eloxatin) 130 mg/m² as a two to six-hour IV infusion on day 1 per chemotherapy cycle.
490611|NCT00382590|B3|Baseline|Total|Total of all reporting groups
490612|NCT00382590|B2|Baseline|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
490613|NCT00382590|B1|Baseline|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
490614|NCT00382590|P2|Participant Flow|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
490615|NCT00382590|P1|Participant Flow|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
490616|NCT00382590|O2|Outcome|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
490617|NCT00382590|O1|Outcome|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
490618|NCT00382590|E2|Reported Event|Ara-C|Low-Dose Cytarabine (Ara-C) 20 mg twice daily subcutaneously for 10 days.
490619|NCT00382590|E1|Reported Event|5-Aza + VPA|5-Azacytidine (5-Aza) 75 mg/m^2 subcutaneously daily + Valproic Acid (VPA) 50 mg/m^2 orally daily, each for 7 days
490620|NCT00382408|B3|Baseline|Total|Total of all reporting groups
490621|NCT00382408|B2|Baseline|Placebo|
490622|NCT00382408|B1|Baseline|Vaccine|
490623|NCT00382408|P2|Participant Flow|Placebo|
490624|NCT00382408|P1|Participant Flow|Vaccine|
490625|NCT00382408|O2|Outcome|Placebo|Oral Type-7-booster placebo
490626|NCT00382408|O1|Outcome|Vaccine|Oral Type-7 booster vaccine
490627|NCT00382408|O2|Outcome|Placebo|ADV Type-4-booster placebo
490628|NCT00382408|O1|Outcome|Vaccine|ADV Type-4 Booster
490632|NCT00382408|O1|Outcome|Vaccine|Oral Type-4 vaccine
490633|NCT00382408|E2|Reported Event|Placebo|
490634|NCT00382408|E1|Reported Event|Vaccine|
490635|NCT00382291|B4|Baseline|Total|Total of all reporting groups
490636|NCT00382291|B3|Baseline|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
490637|NCT00382291|B2|Baseline|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
490638|NCT00382291|B1|Baseline|Placebo|Placebo plus cognitive behavior therapy.
490639|NCT00382291|P3|Participant Flow|Slow Sertraline Titration Plus CBT|Slow titration of sertraline (SloSert)plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
490640|NCT00382291|P2|Participant Flow|Regular Sertraline Titration Plus CBT|Regular titration of sertraline (RegSert) plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
490641|NCT00382291|P1|Participant Flow|Placebo Plus CBT|Placebo plus cognitive behavior therapy (CBT).
490642|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy. The titration schedule utilized a slower titration schedule relative to the RegSert arm. Unless unable to tolerate higher doses, children remained on 25mg/day for the first two weeks, 50mg/day from weeks 3-4, 75mg/day for weeks 5-6, 100mg/day for week 7, 150mg/day for week 8, and 200mg/day for week 9 until the end of the study.
490643|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy. The titration schedule used a flexible upward titration from 25 mg/day to 200 mg/day over 9 weeks unless higher doses were not tolerated, after which the dosage was adjusted as a function of tolerability. If tolerated, maximum dose could be achieved in 5 weeks.
490644|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
490645|NCT00382291|O3|Outcome|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
490646|NCT00382291|O2|Outcome|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
490647|NCT00382291|O1|Outcome|Placebo|Placebo plus cognitive behavior therapy.
490648|NCT00382291|E3|Reported Event|Slow Titration|Slow titration of sertraline plus cognitive behavior therapy.
490649|NCT00382291|E2|Reported Event|Regular Titration|Regular titration of sertraline plus cognitive behavior therapy.
490650|NCT00382291|E1|Reported Event|Placebo|Placebo plus cognitive behavior therapy.
490651|NCT00382174|B3|Baseline|Total|Total of all reporting groups
490652|NCT00382174|B2|Baseline|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
490653|NCT00382174|B1|Baseline|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
490654|NCT00382174|P3|Participant Flow|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
490655|NCT00382174|P2|Participant Flow|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
490656|NCT00382174|P1|Participant Flow|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
490657|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
490658|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
490659|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
490660|NCT00382174|O3|Outcome|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
490661|NCT00382174|O2|Outcome|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
490662|NCT00382174|O1|Outcome|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
490663|NCT00382174|E3|Reported Event|Placebo vs. Thymosin Beta 4 at 3 Doses|Placebo dose 0.00% thymosin beta 4 vs. thymosin beta 4 at 0.01%, 0.02% and 0.1%
490664|NCT00382174|E2|Reported Event|Tβ4 at 3 Doses|0.01% Tβ4,w/w 0.02% Tβ4,w/w 0.1% Tβ4,w/w
490665|NCT00382174|E1|Reported Event|Placebo|0.00% Thymosin Beta 4 (Tβ4), weight/weight (w/w)
490666|NCT00382148|B3|Baseline|Total|Total of all reporting groups
490667|NCT00382148|B2|Baseline|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490668|NCT00382148|B1|Baseline|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490669|NCT00382148|P2|Participant Flow|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490670|NCT00382148|P1|Participant Flow|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490671|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490672|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490673|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490674|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490675|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490676|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490677|NCT00382148|O2|Outcome|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490732|NCT00381849|B3|Baseline|Total|Total of all reporting groups
490678|NCT00382148|O1|Outcome|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490679|NCT00382148|E2|Reported Event|Omalizumab (Omalizumab in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490680|NCT00382148|E1|Reported Event|Omalizumab (Placebo in Q2788g)|Either a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks or 0.008 mg/kg/IgE (IU/mL) every 2 weeks (based on dosing table)
490681|NCT00382109|B3|Baseline|Total|Total of all reporting groups
490682|NCT00382109|B2|Baseline|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
490683|NCT00382109|B1|Baseline|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
490684|NCT00382109|P2|Participant Flow|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
490685|NCT00382109|P1|Participant Flow|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
490686|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490687|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490688|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse pre transplantation (MRD)
490689|NCT00382109|O1|Outcome|All Patients|Relative contribution of ALL blasts to the donor immune response as a cause of relapse post transplantation (correlating development of aGVHD with relapse).
490690|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490691|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490692|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490693|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490694|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490695|NCT00382109|O1|Outcome|Experiemental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490696|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490697|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490698|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490699|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490700|NCT00382109|O2|Outcome|Control|Tacro-MTX GVHD Prophylaxis
490701|NCT00382109|O1|Outcome|Experimental|Tacro-MTX/Sirolimus GVHD Prophylaxis
490702|NCT00382109|E2|Reported Event|Tacro-MTX GVHD Prophylaxis|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally (when able) daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors).
490730|NCT00381862|O1|Outcome|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
490731|NCT00381862|E1|Reported Event|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
490703|NCT00382109|E1|Reported Event|Tacro-MTX/Sirolimus GVHD Prophylaxis Regimen|Preparative regimen of total body irradiation (TBI) 200 cGy BID days -8,-7, & -6, Thiotepa IV (dose 5 mg/kg/day on days -5 & -4) & cyclophosphamide IV (dose 60 mg/kg/day on days -3 & -2). Tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily on day -2 with a taper starting on day 42 - day 98 (patients undergoing matched sibling donor transplantation) OR tacrolimus IV (dose 0.02 mg/kg/day) continuously or orally daily beginning on day -2 followed by a taper on day 100 through day 180 (patients undergoing other related, unrelated, or cord blood donor transplantation) in the absence of GVHD. Patients also receive methotrexate IV (5 mg/m2/dose) on days 1,3, & 6 (patients with matched sibling and umbilical cord blood donors) OR days 1,3 6, & 11 (patients with other related/unrelated bone marrow and peripheral blood stem cell donors) and oral sirolimus (dose 2.5mg/m2/day - 4 mg max starting dose) daily starting on day 0 followed by a taper starting on day 180 through day 207.
490704|NCT00382031|B3|Baseline|Total|Total of all reporting groups
490705|NCT00382031|B2|Baseline|Control|Best Supportive Care
490706|NCT00382031|B1|Baseline|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490707|NCT00382031|P2|Participant Flow|Control|Best Supportive Care
490708|NCT00382031|P1|Participant Flow|Zalutumumab|Zalutumumab in combination with Best Supportive Care. Patients received weekly infusions of zalutumumab. After a loading dose of 8 mg/kg the dose was reduced to 4 mg/kg and individual dose titration based on skin rash evaluation was performed.
490709|NCT00382031|O2|Outcome|Control|Best Supportive Care
490710|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490711|NCT00382031|O2|Outcome|Control|Best Supportive Care
490712|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490713|NCT00382031|O2|Outcome|Control|Best Supportive Care
490714|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490715|NCT00382031|O2|Outcome|Control|Best Supportive Care
490716|NCT00382031|O1|Outcome|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490717|NCT00382031|E2|Reported Event|Control|Best Supportive Care
490718|NCT00382031|E1|Reported Event|Zalutumumab|Zalutumumab in combination with Best Supportive Care
490719|NCT00381940|B1|Baseline|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
490720|NCT00381940|P1|Participant Flow|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
490721|NCT00381940|O1|Outcome|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
490722|NCT00381940|E1|Reported Event|Treatment (Ifosfamide, Vinorelbine, Bortezomib)|"This was a single arm study that treated all patients with ifosfamide, vinorelbine, and bortezomib. Patients received ifosfamide IV (3000 mg/m2/day) continuously over days 1-4, vinorelbine ditartrate IV (25 mg/m2/dose) over 6-10 minutes on days 1 and 5, bortezomib IV (1.2 mg/m2/dose) on days 1, 4, and 8, and filgrastim (G-CSF) IV or subcutaneously beginning on day 6 and continuing until blood counts recover or PBSC are harvested. Treatment cycle repeats every 21 days for up to 2 or 4 courses in the absence of disease progression or unacceptable toxicity.~Patients undergo autologous PBSC harvesting according to institutional guidelines after the second course of therapy.~ifosfamide: Given IV~bortezomib: Given IV~vinorelbine ditartrate: Given IV~filgrastim: Given IV or SC"
490723|NCT00381888|B1|Baseline|Patients Enrolled and Consented|This number includes all patients that were consented and enrolled in the study and received at least one dose of study drug.
490724|NCT00381888|P1|Participant Flow|Patients Enrolled and Consented|This number includes all patients consented and enrolled in this study.
490725|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
490726|NCT00381888|O1|Outcome|Fondaparinux Patients Who Completed Study|This number includes all patients that completed 4 weeks of the study and were treated with 2.5 mg of Fondaparinux on days 1-28.
490727|NCT00381888|E1|Reported Event|All Patients Who Received at Least One Dose of Fondaparinux|This number includes all patients that received one or more doses of study drug. All events were determined to be unrelated to Fondaparinux.
490728|NCT00381862|B1|Baseline|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
490729|NCT00381862|P1|Participant Flow|Aprepitant and Palonosetron|"Aprepitant: 125 mg by mouth (PO) on day 1 and 80 mg PO on days 2 and 3 of each chemotherapy cycle~Palonosetron: 0.25 mg IV push on day 1 only"
490733|NCT00381849|B2|Baseline|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490734|NCT00381849|B1|Baseline|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490735|NCT00381849|P2|Participant Flow|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490736|NCT00381849|P1|Participant Flow|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490737|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490738|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490739|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490740|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490741|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490742|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490743|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490744|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490745|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490746|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490747|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490748|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490749|NCT00381849|O2|Outcome|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490750|NCT00381849|O1|Outcome|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490751|NCT00381849|E2|Reported Event|Cystine Stone Subjects|Subjects with confirmed cystine kidney stone(s)
490752|NCT00381849|E1|Reported Event|Calcium Stone Subjects|Subjects with confirmed calcium kidney stone(s)
490753|NCT00381810|B1|Baseline|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
490754|NCT00381810|P1|Participant Flow|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
490755|NCT00381810|O1|Outcome|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
490756|NCT00381810|E1|Reported Event|Rituximab 1000 mg|Participants received rituximab 1000 mg intravenously twice, 14 days apart at study entry and again 6 months later. Participants also received methylprednisolone 100 or 125 mg IV, acetaminophen 1000 mg orally, and diphenhydramine 50 mg orally prior to study drug infusion.
490757|NCT00381797|B6|Baseline|Total|Total of all reporting groups
490758|NCT00381797|B5|Baseline|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490759|NCT00381797|B4|Baseline|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490760|NCT00381797|B3|Baseline|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490761|NCT00381797|B2|Baseline|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490992|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490762|NCT00381797|B1|Baseline|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490763|NCT00381797|P5|Participant Flow|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490764|NCT00381797|P4|Participant Flow|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490765|NCT00381797|P3|Participant Flow|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490766|NCT00381797|P2|Participant Flow|Brain Stem Tumors|Recurrent,progressive or refractory intrinsic brain stem tumors (Stratum B): The only patients with Recurrent,progressive or refractory intrinsic brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490767|NCT00381797|P1|Participant Flow|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490768|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490769|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490907|NCT00381485|P3|Participant Flow|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490993|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490770|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490771|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490772|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490773|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490774|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490775|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490776|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent, progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490777|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B): The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490857|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490778|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490779|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490780|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490781|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490782|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490783|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490784|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490785|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent,progressive or refractory instrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490908|NCT00381485|P2|Participant Flow|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490786|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490787|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490788|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490789|NCT00381797|O4|Outcome|Low Grade Glioma|Recurrent low grade glioma(Stratum E):The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490790|NCT00381797|O3|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D):The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490791|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490792|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490793|NCT00381797|O3|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490858|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490794|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory Brain Stem Tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490795|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490796|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent, progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490797|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C): The only patients with Recurrent or progressive Medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490798|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490799|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490800|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E): The only patients with Recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490801|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with Recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490859|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490980|NCT00381303|O7|Outcome|Other|
490802|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with Recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490803|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with Recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490804|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A):The only patients with Recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490805|NCT00381797|O5|Outcome|Low Grade Glioma|Recurrent or progressive low grade glioma(Stratum E):The only patients with recurrent or progressive low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490806|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma(Stratum D): The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490807|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490808|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors(Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490809|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas(Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490860|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490981|NCT00381303|O6|Outcome|Asian|
490810|NCT00381797|O1|Outcome|Low Grade Glioma|Recurrent low grade glioma (Stratum E): The only patients with recurrent low grade glioma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490811|NCT00381797|O4|Outcome|Ependymoma|Recurrent or progressive ependymoma (Stratum D):The only patients with recurrent or progressive ependymoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490812|NCT00381797|O3|Outcome|Medulloblastoma|Recurrent or progressive medulloblastoma(Stratum C):The only patients with recurrent or progressive medulloblastoma were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490813|NCT00381797|O2|Outcome|Brain Stem Tumors|Recurrent, progressive or refractory intrinsic brain stem tumors (Stratum B):The only patients with recurrent, progressive or refractory brain stem tumors were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490814|NCT00381797|O1|Outcome|High-grade Gliomas|Recurrent, progressive or refractory high-grade gliomas (Stratum A): The only patients with recurrent, progressive or refractory high-grade gliomas were treated in this arm. Therapy will begin with single-agent bevacizumab 10 mg/kg given intravenously (i.v) on day 1 and day 15 (+/- 24 hours) followed by MR-perfusion/diffusion imaging within 24-48 hours following the 2nd dose of bevacizumab. The first dose of irinotecan will be given i.v following this MR-perfusion scan. Subsequently, bevacizumab and irinotecan will be given every two weeks. The irinotecan dose will depend on whether the patient is on an enzyme-inducing anticonvulsant drug (EIACD). The irinotecan dose will be 250 mg/m2 (~ 80 % of dose tolerated by adults in the Duke Phase II study of bevacizumab plus irinotecan) every two weeks for those on EIACDs. If the patient is not on an EIACD, the starting dose will be 125 mg/m2.
490815|NCT00381797|E1|Reported Event|PBTC-022|Children with recurrent,progressive,or refractory malignant gliomas, diffuse/intrinsic brain stem gliomas, medulloblastomas and low grade gliomas
490816|NCT00381693|B1|Baseline|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490817|NCT00381693|P1|Participant Flow|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490818|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490819|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490820|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490821|NCT00381693|O1|Outcome|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490822|NCT00381693|E1|Reported Event|Azacitidine|Azacitidine 75 mg/m^2 subcutaneously
490823|NCT00381628|B5|Baseline|Total|Total of all reporting groups
490824|NCT00381628|B4|Baseline|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490825|NCT00381628|B3|Baseline|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490826|NCT00381628|B2|Baseline|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490982|NCT00381303|O5|Outcome|Hispanic|
490983|NCT00381303|O4|Outcome|Caucasian|
490827|NCT00381628|B1|Baseline|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490828|NCT00381628|P4|Participant Flow|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490829|NCT00381628|P3|Participant Flow|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490830|NCT00381628|P2|Participant Flow|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490831|NCT00381628|P1|Participant Flow|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490832|NCT00381628|O4|Outcome|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490833|NCT00381628|O3|Outcome|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490834|NCT00381628|O2|Outcome|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490835|NCT00381628|O1|Outcome|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490836|NCT00381628|E4|Reported Event|Healthy Volunteers|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the control group~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490837|NCT00381628|E3|Reported Event|Stable Subjects With Asthma|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro. This is the disease control group.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490904|NCT00381485|B2|Baseline|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490984|NCT00381303|O3|Outcome|Black|
490985|NCT00381303|O2|Outcome|Male|
490838|NCT00381628|E2|Reported Event|Exacerbating Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) at the beginning and end of treatment for a pulmonary exacerbation. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490839|NCT00381628|E1|Reported Event|Stable Subjects With CF|"These subjects will undergo epithelial cells and blood lymphocyte extraction. Nasal curettage will be performed to obtain nasal epithelial cells and blood will be obtained to isolate circulating lymphocytes one time from these subjects (age 15 years and above) when they are in their usual state of well-health. These cells will be studied in vitro.~epithelial cells and blood lymphocyte extraction: Nasal curettage will be performed from each nostril to obtain nasal epithelial cells. Venipuncture will be performed and up to 60-ml of blood will be obtained from which neutrophils will be isolated."
490840|NCT00381615|B5|Baseline|Total|Total of all reporting groups
490841|NCT00381615|B4|Baseline|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490842|NCT00381615|B3|Baseline|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490843|NCT00381615|B2|Baseline|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490844|NCT00381615|B1|Baseline|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490845|NCT00381615|P4|Participant Flow|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490846|NCT00381615|P3|Participant Flow|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490847|NCT00381615|P2|Participant Flow|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490848|NCT00381615|P1|Participant Flow|rMenB|"Infants received 4 doses of recombinant meningococcal serogroup B (rMenB) vaccine without Outer Membrane Vesicle (OMV-NZ) at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of diphtheria-tetanus-acellular pertussis vaccine (DTaP-Hib-IPV) (at 2, 3, and 4 months) and Heptavalent Pneumococcal Conjugate (PC7) (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and Measles Mumps Rubella (MMR) (at 13 months)."
490849|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490850|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490851|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490852|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490853|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
490854|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
490855|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490856|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines – 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490986|NCT00381303|O1|Outcome|Female|
490987|NCT00381303|O5|Outcome|Other|
490861|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490862|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490863|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490864|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490865|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490866|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490867|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490868|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490869|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490870|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490871|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490872|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490873|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490874|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490875|NCT00381615|O4|Outcome|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490876|NCT00381615|O3|Outcome|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490877|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490878|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490879|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
490880|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
490905|NCT00381485|B1|Baseline|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490988|NCT00381303|O4|Outcome|Asian|
490881|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490882|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490883|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
490884|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
490885|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490886|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490887|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490888|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490889|NCT00381615|O2|Outcome|Routine+OMV|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine with OMV NZ at 12 months of age.
490890|NCT00381615|O1|Outcome|Routine|Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months). Infants also received single dose of rMenB vaccine without OMV NZ at 12 months of age.
490891|NCT00381615|O2|Outcome|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490892|NCT00381615|O1|Outcome|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490893|NCT00381615|E4|Reported Event|Routine+OMV|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine with OMV-NZ at 12 months of age."
490894|NCT00381615|E3|Reported Event|Routine|"Infants received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months).~Infants also received single dose of rMenB vaccine without OMV-NZ at 12 months of age."
490895|NCT00381615|E2|Reported Event|rMenB+OMV|"Infants received 4 doses of rMenB vaccine with OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490896|NCT00381615|E1|Reported Event|rMenB|"Infants received 4 doses of rMenB vaccine without OMV-NZ at 2, 4, 6 and 12 months of age.~Infants also received routine vaccines - 3 doses each of DTaP-Hib-IPV (at 2, 3, and 4 months) and PC7 (at 2, 4 and 13 months), 2 doses of MenC-CRM (at 3 and 5 months) and 1 dose each of MenC-Hib (at 12 months) and MMR (at 13 months)."
490897|NCT00381550|B1|Baseline|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
490898|NCT00381550|P1|Participant Flow|Triapine and Fludarabine Phosphate|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
490899|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
490900|NCT00381550|O1|Outcome|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
490901|NCT00381550|E1|Reported Event|Arm I|Patients receive 3-AP (Triapine®) IV over 4 hours followed by fludarabine phosphate IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
490902|NCT00381485|B4|Baseline|Total|Total of all reporting groups
490903|NCT00381485|B3|Baseline|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490906|NCT00381485|P4|Participant Flow|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490909|NCT00381485|P1|Participant Flow|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
490910|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490911|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490912|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490913|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490914|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490915|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490916|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490917|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490918|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490919|NCT00381485|O3|Outcome|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490920|NCT00381485|O2|Outcome|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490921|NCT00381485|O1|Outcome|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490922|NCT00381485|E4|Reported Event|Open-Label MF MDI 400 mcg BID|Participants received 2 to 3 weeks (approximately) of open-label, run-in medication with MF MDI 400 mcg BID prior to the 12-week double-blind treatment period.
490923|NCT00381485|E3|Reported Event|MF MDI 400 mcg BID|Participants received Mometasone Furoate 400 mcg taken twice daily for 12 weeks.
490924|NCT00381485|E2|Reported Event|MF/F MDI 200/10 mcg BID|Participants received mometasone Furoate 200 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490925|NCT00381485|E1|Reported Event|MF/F MDI 400/10 mcg BID|Participants received mometasone Furoate 400 mcg and formoterol 10 mcg fixed dose combination taken twice daily for 12 weeks.
490926|NCT00381381|B1|Baseline|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490927|NCT00381381|P1|Participant Flow|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490928|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490929|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490930|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490931|NCT00381381|O1|Outcome|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490932|NCT00381381|E1|Reported Event|Donepezil|Initial dose was 2.5 mg/day, and the maximum dose was 10 mg/day.
490933|NCT00381303|B3|Baseline|Total|Total of all reporting groups
490934|NCT00381303|B2|Baseline|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490935|NCT00381303|B1|Baseline|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490936|NCT00381303|P2|Participant Flow|Male|darunavir 600 mg twice bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490937|NCT00381303|P1|Participant Flow|Female|darunavir 600 milligram (mg) twice daily dosing (bid) for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490938|NCT00381303|O7|Outcome|Other|
490939|NCT00381303|O6|Outcome|Asian|
490940|NCT00381303|O5|Outcome|Hispanic|
490941|NCT00381303|O4|Outcome|Caucasian|
490942|NCT00381303|O3|Outcome|Black|
490943|NCT00381303|O2|Outcome|Male|
490944|NCT00381303|O1|Outcome|Female|
490945|NCT00381303|O2|Outcome|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490946|NCT00381303|O1|Outcome|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490947|NCT00381303|O7|Outcome|Other|
490948|NCT00381303|O6|Outcome|Asian|
490949|NCT00381303|O5|Outcome|Hispanic|
490950|NCT00381303|O4|Outcome|Caucasian|
490951|NCT00381303|O3|Outcome|Black|
490952|NCT00381303|O2|Outcome|Male|
490953|NCT00381303|O1|Outcome|Female|
490954|NCT00381303|O7|Outcome|Other|
490955|NCT00381303|O6|Outcome|Asian|
490956|NCT00381303|O5|Outcome|Hispanic|
490957|NCT00381303|O4|Outcome|Caucasian|
490958|NCT00381303|O3|Outcome|Black|
490959|NCT00381303|O2|Outcome|Male|
490960|NCT00381303|O1|Outcome|Female|
490961|NCT00381303|O7|Outcome|Other|
490962|NCT00381303|O6|Outcome|Asian|
490963|NCT00381303|O5|Outcome|Hispanic|
490964|NCT00381303|O4|Outcome|Caucasian|
490965|NCT00381303|O3|Outcome|Black|
490966|NCT00381303|O2|Outcome|Male|
490967|NCT00381303|O1|Outcome|Female|
490968|NCT00381303|O7|Outcome|Other|
490969|NCT00381303|O6|Outcome|Asian|
490970|NCT00381303|O5|Outcome|Hispanic|
490971|NCT00381303|O4|Outcome|Caucasian|
490972|NCT00381303|O3|Outcome|Black|
490973|NCT00381303|O2|Outcome|Male|
490974|NCT00381303|O1|Outcome|Female|
490975|NCT00381303|O5|Outcome|Other|
490976|NCT00381303|O4|Outcome|Asian|
490977|NCT00381303|O3|Outcome|Hispanic|
490978|NCT00381303|O2|Outcome|Caucasian|
490979|NCT00381303|O1|Outcome|Black|
490994|NCT00381303|E2|Reported Event|Male|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490995|NCT00381303|E1|Reported Event|Female|darunavir (DRV) 600 mg bid for 48 weeks administered with ritonavir 100 mg bid for 48 weeks.
490996|NCT00381095|B3|Baseline|Total|Total of all reporting groups
490997|NCT00381095|B2|Baseline|Placebo|Matching placebo capsules orally twice per day
490998|NCT00381095|B1|Baseline|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
490999|NCT00381095|P2|Participant Flow|Placebo|Matching placebo capsules orally twice per day
491000|NCT00381095|P1|Participant Flow|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491001|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491002|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491003|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491004|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491005|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491006|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491007|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491008|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491009|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491010|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491011|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491012|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491013|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491014|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491015|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491016|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491017|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491018|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491019|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491020|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491021|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491022|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491023|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491024|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491025|NCT00381095|O2|Outcome|Placebo|Matching placebo capsules orally twice per day
491026|NCT00381095|O1|Outcome|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491027|NCT00381095|E2|Reported Event|Placebo|Matching placebo capsules orally twice per day
491028|NCT00381095|E1|Reported Event|Pregabalin|Pregabalin Flexible Dose 50 to 300 milligrams (mg) capsules orally twice per day (100 to 600 mg/day) for 28 days. Dose adjustments from Day 2 up to Day 14 as needed, followed by fixed dosing through Day 28, followed by dose tapering to Day 34
491029|NCT00381043|B3|Baseline|Total|Total of all reporting groups
491030|NCT00381043|B2|Baseline|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491031|NCT00381043|B1|Baseline|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491032|NCT00381043|P2|Participant Flow|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491033|NCT00381043|P1|Participant Flow|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491034|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491035|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491036|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491037|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491038|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491039|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491040|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491041|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491042|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491043|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491044|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491045|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491046|NCT00381043|O2|Outcome|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491047|NCT00381043|O1|Outcome|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491048|NCT00381043|E2|Reported Event|2 - Sugar Pill - Placebo|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491049|NCT00381043|E1|Reported Event|1- Acamprosate|The study is a double-blind, randomized, placebo-controlled clinical trial in which participants will receive 333 mg t.i.d. oral acamprosate or matching placebo for a 12-week period. Each participant will also receive brief behavioral intervention at each visit.
491050|NCT00381004|B1|Baseline|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491051|NCT00381004|P1|Participant Flow|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491052|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491076|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491053|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491054|NCT00381004|O1|Outcome|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491055|NCT00381004|E1|Reported Event|FCR + Sargramostim|Fludarabine + Cyclophosphamide + Rituximab (FCR) = Fludarabine - Course 1: 25 mg/m^2 IV Days 2-4; Course 2-6: 25 mg/m^2 IV Days 1-3. Cyclophosphamide - Course 1: 250 mg/m^2 intravenous (IV) Days 2-4; Course 2-6: 250 mg/m^2 Days 1-3. Rituximab - Course 1: 375 mg/m^2 IV over 2-6 hours Day 1; Course 2-6: 500 mg/m^2 IV Day 1. Sargramostim - Course 1: 250 mcg/m^2 subcutaneous (SQ) Days -1 and 5-11; Course 2-6: 250 mcg/m^2 SQ Days -1 and 4-10.
491056|NCT00380978|B3|Baseline|Total|Total of all reporting groups
491057|NCT00380978|B2|Baseline|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491058|NCT00380978|B1|Baseline|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491059|NCT00380978|P2|Participant Flow|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491060|NCT00380978|P1|Participant Flow|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491061|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491062|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491063|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491064|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491065|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491066|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491067|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491068|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491069|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491070|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491071|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491072|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491073|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491074|NCT00380978|O1|Outcome|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491075|NCT00380978|O2|Outcome|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491221|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491222|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491077|NCT00380978|E2|Reported Event|Systemic Analgesia|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive hydromorphone 1mg IM and 1mg IV until cervical dilation greater than 4 cm or third request for analgesia. Epidural
491078|NCT00380978|E1|Reported Event|Early Analgesia:Combined-spinal Epidural|Laboring women with induction of labor requesting analgesia at cervical dilation less than 4 cm randomized to receive spinal fentanyl 25 micrograms and epidural bupivacaine 6.25 mg/ml and fentanyl 1.96 micrograms/ml for labor analgesia.
491079|NCT00380874|B3|Baseline|Total|Total of all reporting groups
491080|NCT00380874|B2|Baseline|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491081|NCT00380874|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491082|NCT00380874|P2|Participant Flow|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491083|NCT00380874|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491084|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491085|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491086|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491087|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491088|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491089|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491090|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491091|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491092|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491093|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491094|NCT00380874|O2|Outcome|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491095|NCT00380874|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491096|NCT00380874|E2|Reported Event|Placebo|matching placebo + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA).
491097|NCT00380874|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligrams per day (mg/day) flexible dose + chemotherapy (oxaliplatin combined with 5-fluorouracil/folinic acid (5-FU/FA). Possible dose levels of pregabalin were 150 mg/day (75 mg capsules twice a day [BID]), 300 mg/day (150 mg capsules BID) or 600 mg/day (300 mg capsules BID).
491098|NCT00380861|B3|Baseline|Total|Total of all reporting groups
491099|NCT00380861|B2|Baseline|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
491100|NCT00380861|B1|Baseline|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
491101|NCT00380861|P2|Participant Flow|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
491102|NCT00380861|P1|Participant Flow|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
491103|NCT00380861|O2|Outcome|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
491104|NCT00380861|O1|Outcome|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
491105|NCT00380861|E2|Reported Event|PFC® Sigma™ RP, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP design in the one knee to the PFC Sigma RP-F design in the other knee.
491106|NCT00380861|E1|Reported Event|PFC® Sigma™ RP-F, Posterior Stabilized Total Knee Replacement|Comparison of PFC Sigma RP-F design in the one knee to the PFC Sigma RP design in the other knee.
491107|NCT00380718|B1|Baseline|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491108|NCT00380718|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491109|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491110|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491111|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491112|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491113|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491114|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491115|NCT00380718|O1|Outcome|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491116|NCT00380718|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days until disease progression (toxicity in cycle 1 determines dose increase to 1000 mg/m2 or dose decrease to 375 mg/m2 in subsequent cycles).
491117|NCT00380692|B3|Baseline|Total|Total of all reporting groups
491118|NCT00380692|B2|Baseline|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491119|NCT00380692|B1|Baseline|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491120|NCT00380692|P2|Participant Flow|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491121|NCT00380692|P1|Participant Flow|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491122|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491123|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491124|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491125|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491126|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491127|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491128|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491129|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491130|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491131|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491132|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491133|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491134|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491135|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491136|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491137|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491138|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491139|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491140|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491141|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491142|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491143|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491144|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491145|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491146|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491147|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491148|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491149|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491150|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491151|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491152|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491153|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491154|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491155|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491156|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491157|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491158|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491159|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491160|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491161|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491162|NCT00380692|O2|Outcome|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491163|NCT00380692|O1|Outcome|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491164|NCT00380692|E2|Reported Event|Placebo|"placebo: daily (QD), by mouth (PO) for 8 weeks.~Then patients can take atomoxetine 0.5-1.2 mg/kg/day QD, PO up to 20 weeks."
491165|NCT00380692|E1|Reported Event|Atomoxetine|atomoxetine: 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, atomoxetine 0.8mg/kg/day QD, PO for 1 week, 1.2mg/kg/day QD, PO for 6 weeks then atomoxetine 0.5-1.2 mg/kg/day QD, PO for up to 20 weeks.
491166|NCT00380588|B3|Baseline|Total|Total of all reporting groups
491167|NCT00380588|B2|Baseline|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491168|NCT00380588|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491169|NCT00380588|P2|Participant Flow|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491170|NCT00380588|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491171|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491172|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491173|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491223|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491174|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491175|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491176|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491177|NCT00380588|O2|Outcome|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491178|NCT00380588|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491179|NCT00380588|E2|Reported Event|Gemcitabine|Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1,8 and 15 every 28 days x 12 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.
491180|NCT00380588|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1000 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal.~Cisplatin: 25 milligrams per square meter (mg/m2), intravenous (IV), day 1 and day 8 every 21 days x 16 maximum cycles or disease progression or unacceptable toxicity or patient withdrawal."
491181|NCT00380367|B1|Baseline|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Subjects who were enrolled received Quadrivalent Human Papilloma Virus (HPV) VLP (Virus like particles) vaccine (6,11,16,18) given on day 1, month 2 and month 6
491182|NCT00380367|P1|Participant Flow|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Subjects who were enrolled received Quadrivalent Human Papilloma Virus (HPV) VLP (Virus like particles) vaccine (6,11,16,18) given on day 1, month 2 and month 6
491183|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Subjects who were enrolled received Quadrivalent Human Papilloma Virus (HPV) VLP (Virus like particles) vaccine (6,11,16,18) given on day 1, month 2 and month 6
491184|NCT00380367|O1|Outcome|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Subjects who were enrolled received Quadrivalent Human Papilloma Virus (HPV) VLP (Virus like particles) vaccine (6,11,16,18) given on day 1, month 2 and month 6
491185|NCT00380367|E1|Reported Event|Quadrivalent HPV VLP Vaccine (Types 6, 11, 16, 18)|Subjects who were enrolled received Quadrivalent Human Papilloma Virus (HPV) VLP (Virus like particles) vaccine (6,11,16,18) given on day 1, month 2 and month 6
491186|NCT00380250|B3|Baseline|Total|Total of all reporting groups
491187|NCT00380250|B2|Baseline|Placebo Study Period I|Subjects who received placebo
491188|NCT00380250|B1|Baseline|Lubiprostone Study Period I|Subjects who received active drug
491189|NCT00380250|P2|Participant Flow|Placebo Study Period I|Subjects who received placebo
491190|NCT00380250|P1|Participant Flow|Lubiprostone Study Period I|Subjects who received active drug
491191|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491192|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491193|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491194|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491195|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491196|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491197|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491198|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491199|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491200|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491201|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491202|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491203|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491204|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491205|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491206|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491207|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491208|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491209|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491210|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491211|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491212|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491213|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491214|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491215|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491216|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491217|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491218|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491219|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491220|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491224|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491225|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491226|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491227|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491228|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491229|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491230|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491231|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491232|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491233|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491234|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491235|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491236|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491237|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491238|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491239|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491240|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491241|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491242|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491243|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491244|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491245|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491246|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491247|NCT00380250|O2|Outcome|Placebo Study Period I|Subjects who received placebo
491248|NCT00380250|O1|Outcome|Lubiprostone Study Period I|Subjects who received active drug
491249|NCT00380250|E2|Reported Event|Placebo Study Period I|Matching placebo capsules twice daily (BID)
491250|NCT00380250|E1|Reported Event|Lubiprostone Study Period I|8 mcg capsules twice daily (BID)
491251|NCT00380081|B7|Baseline|Total|Total of all reporting groups
491252|NCT00380081|B6|Baseline|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
491253|NCT00380081|B5|Baseline|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
491254|NCT00380081|B4|Baseline|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
491255|NCT00380081|B3|Baseline|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
491256|NCT00380081|B2|Baseline|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
491257|NCT00380081|B1|Baseline|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
491258|NCT00380081|P6|Participant Flow|Zolpidem 1.75/Zolpidem 3.5/Placebo|Cross-over interventions administered in the order listed.
491259|NCT00380081|P5|Participant Flow|Zolpidem 1.75/Placebo/Zolpidem 3.5|Cross-over interventions administered in the order listed.
491260|NCT00380081|P4|Participant Flow|Zolpidem 3.5/Zolpidem 1.75/Placebo|Cross-over interventions administered in the order listed.
491261|NCT00380081|P3|Participant Flow|Zolpidem 3.5/Placebo/Zolpidem 1.75|Cross-over interventions administered in the order listed.
491262|NCT00380081|P2|Participant Flow|Placebo/Zolpidem 1.75/Zolpidem 3.5|Cross-over interventions administered in the order listed.
491263|NCT00380081|P1|Participant Flow|Placebo/Zolpidem 3.5/Zolpidem 1.75|Cross-over interventions administered in the order listed.
491264|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491265|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491266|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491267|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491268|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491269|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491270|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491271|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491272|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491273|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491303|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491274|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491275|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491276|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491277|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491278|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491279|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491280|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491281|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491282|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491283|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491284|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491285|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491286|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491287|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491288|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491289|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491290|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491291|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491292|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491293|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491294|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491295|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491296|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491297|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491298|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491299|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491300|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491301|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491302|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491782|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
491304|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491305|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491306|NCT00380081|O3|Outcome|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491307|NCT00380081|O2|Outcome|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491308|NCT00380081|O1|Outcome|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491309|NCT00380081|E3|Reported Event|Placebo|Placebo sublingual tablet administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491310|NCT00380081|E2|Reported Event|Zolpidem 1.75 mg|Zolpidem tartrate sublingual tablet 1.75 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491311|NCT00380081|E1|Reported Event|Zolpidem 3.5 mg|Zolpidem tartrate sublingual tablet 3.5 milligram administered between 2:15 and 3:15 a.m. on Night 1 and 2 of each treatment period. Participants placed the study drug under the tongue until it dissolved.
491312|NCT00380068|B1|Baseline|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491313|NCT00380068|P1|Participant Flow|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491314|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491315|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491316|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491317|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491318|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491319|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491320|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491321|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491322|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491323|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491371|NCT00379821|B1|Baseline|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491372|NCT00379821|P4|Participant Flow|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491324|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491325|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491326|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491327|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491328|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491329|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491330|NCT00380068|O1|Outcome|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491331|NCT00380068|E1|Reported Event|Ambrisentan|Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg).
491332|NCT00379899|B3|Baseline|Total|Total of all reporting groups
491333|NCT00379899|B2|Baseline|Control|Flexible vitamin D dosing
491334|NCT00379899|B1|Baseline|Cinacalcet|Cinacalcet plus low dose vitamin D
491335|NCT00379899|P2|Participant Flow|Control|Flexible vitamin D dosing
491336|NCT00379899|P1|Participant Flow|Cinacalcet|Cinacalcet plus low dose vitamin D
491337|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491338|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491339|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491340|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491341|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491342|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491343|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491344|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491345|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491346|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491347|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491348|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491349|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491350|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491351|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491352|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491353|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491354|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491355|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491356|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491357|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491358|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491359|NCT00379899|O2|Outcome|Control|Flexible vitamin D dosing
491360|NCT00379899|O1|Outcome|Cinacalcet|Cinacalcet plus low dose vitamin D
491361|NCT00379899|E2|Reported Event|Control Group|
491362|NCT00379899|E1|Reported Event|Cinacalcet|
491363|NCT00379834|B1|Baseline|Cosopt|Cosopt BID OU
491364|NCT00379834|P1|Participant Flow|Cosopt|Cosopt BID OU
491365|NCT00379834|O1|Outcome|Cosopt|Cosopt twice daily in both eyes
491366|NCT00379834|E1|Reported Event|Cosopt|Cosopt twice daily in both eyes
491367|NCT00379821|B5|Baseline|Total|Total of all reporting groups
491368|NCT00379821|B4|Baseline|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491369|NCT00379821|B3|Baseline|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491370|NCT00379821|B2|Baseline|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491783|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
491373|NCT00379821|P3|Participant Flow|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491374|NCT00379821|P2|Participant Flow|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491375|NCT00379821|P1|Participant Flow|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491376|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491377|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491378|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491379|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491380|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491381|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491382|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491383|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491384|NCT00379821|O1|Outcome|All Groups|Participants Receiving Any Treatment in the Study
491385|NCT00379821|O2|Outcome|Participants Who Did Not Travel and Sleep Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated no.
491386|NCT00379821|O1|Outcome|Participants Who Traveled and Slept Outside the City|At enrollment, participants were asked if they travelled and slept outside the city within the previous 4 weeks. This group indicated yes.
491387|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491388|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491389|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491390|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491391|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491392|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491393|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491394|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491395|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491396|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491397|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491398|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491399|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491400|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491401|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491402|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491403|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491404|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491784|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
493954|NCT00371540|O2|Outcome|II Home Visits|
491405|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491406|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491407|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491408|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491409|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491410|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491411|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491412|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491413|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491414|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491415|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491416|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491417|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491418|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491419|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491420|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491421|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491422|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491423|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491424|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491425|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491426|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491427|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491428|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491429|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491430|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491431|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491432|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491433|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491434|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491435|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
493955|NCT00371540|O1|Outcome|I Rountine Care|
491436|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491437|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491438|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491439|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491440|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491441|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491442|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491443|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491444|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491445|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491446|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491447|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491448|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491449|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491450|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491451|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491452|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491453|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491454|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491455|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491456|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491457|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491458|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491459|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491460|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491461|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491462|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491463|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491464|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491465|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491466|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
493956|NCT00371540|E2|Reported Event|II Home Visits|
491467|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491468|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491469|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491470|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491471|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491472|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491473|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491474|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491475|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491476|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491477|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491478|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491479|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491480|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491481|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491482|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491483|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491484|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491485|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491486|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491487|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491488|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491489|NCT00379821|O2|Outcome|CQ Plus Azithromycin|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491490|NCT00379821|O1|Outcome|Chloroquine Plus Atovaquone-Proguanil|Subjects receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491491|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491492|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491493|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491494|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491495|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491496|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491497|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
493957|NCT00371540|E1|Reported Event|I Rountine Care|
491498|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491499|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491500|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491501|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491502|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491503|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491504|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491505|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491506|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491507|NCT00379821|O4|Outcome|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491508|NCT00379821|O3|Outcome|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491509|NCT00379821|O2|Outcome|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491510|NCT00379821|O1|Outcome|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491511|NCT00379821|E4|Reported Event|CQ Monotherapy|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2.
491512|NCT00379821|E3|Reported Event|CQ Plus Azithromycin|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Azithromycin 30 mg/kg once a day for 3 days.
491513|NCT00379821|E2|Reported Event|Chloroquine Plus Atovaquone-Proguanil|Participants receive CQ at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Atovaquone-Proguanil (AP) once a day for 3 days dosed as follows: 5-8 kg, 2 pediatric tablet (PT, 62.5 mg/25mg); 9-10 kg, 3 PT; 11-20 kg, 1 full strength tablet (FST, 250mg/100 mg); 21-30 kg 2 FST; >30 kg, 3 FST.
491514|NCT00379821|E1|Reported Event|Chloroquine Plus Artesunate|Participants receive chloroquine (CQ) at 10 mg/kg on days 0 and 1, and 5 mg/kg/day on day 2; plus Artesunate at a dose of 4 mg/kg once a day for 3 days.
491515|NCT00379808|B1|Baseline|All Participants|Patients were randomized in a crossover design, but baseline characteristics were presented for all participants. Likewise data are not separated by order of treatment because there were no order effects
491516|NCT00379808|P2|Participant Flow|Montelukast Then Placebo|Patients were randomized in a crossover design to placebo or montelukast. Patients in this arm got montelukast for 4 weeks and then placebo for 4 weeks. There was no washout period
491517|NCT00379808|P1|Participant Flow|Placebo Then Montelukast|Patients were randomized in a crossover design to placebo or montelukast. Patients int this randomization arm received 4 weeks of placebo then 4 weeks of montelukast. There was no washout between crossover
491518|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491519|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491520|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491521|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491522|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491523|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491524|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491525|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491526|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491527|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491528|NCT00379808|O2|Outcome|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491529|NCT00379808|O1|Outcome|Placebo|This is all participants who received placebo, whether in first or second intervention
491530|NCT00379808|E2|Reported Event|Montelukast|This is all patients who received montelukast, whether in the first or second intervention period
491531|NCT00379808|E1|Reported Event|Placebo|This is all participants who received placebo, whether in first or second intervention
491532|NCT00379795|B6|Baseline|Total|Total of all reporting groups
491533|NCT00379795|B5|Baseline|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were previously enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594), FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or in this extension study (FVF3426g).
491785|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491534|NCT00379795|B4|Baseline|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injections in previous studies FVF2428g, study FVF2587g or this extension study.
491535|NCT00379795|B3|Baseline|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5mg intravitreal injections in previous study FVF2598g or in this extension study.
491536|NCT00379795|B2|Baseline|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injections in combination with photodynamic therapy in Study FVF2428g.
491537|NCT00379795|B1|Baseline|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab 0.5 mg monotherapy, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
491538|NCT00379795|P5|Participant Flow|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) FVF2598g (NCT0056823) but did not receive Ranibizumab intravitreal injections in that study or in this extension study (FVF3426g).
491539|NCT00379795|P4|Participant Flow|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in study FVF2428g or study FVF2587g before crossing over to receive ranibizumab intravitreal injections in study FVF2428g, study FVF2587g or this study.
491540|NCT00379795|P3|Participant Flow|RanibizumabTreated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab intravitreal injections in study FVF2598g or this extension study.
491541|NCT00379795|P2|Participant Flow|RanibizumabTreated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab in combination with photodynamic therapy in Study FVF2428g
491542|NCT00379795|P1|Participant Flow|RanibizumabTreated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group received ranibizumab monotherapy (Mono) in previous studies, that is, ranibizumab alone in study FVF2598g or ranibizumab in combination with sham photodynamic therapy (PDT) in study FVF2587g.
491543|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
491544|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
491545|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
491561|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
491546|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
491547|NCT00379795|O4|Outcome|Total|All enrolled subjects
491548|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
491549|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in the initial study or this extension study.
491550|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
491551|NCT00379795|O4|Outcome|Total|All enrolled subjects
491552|NCT00379795|O3|Outcome|Ranibizumab Untreated Group|In this extension study participants did not receive Ranibizumab. Participants in this group were enrolled in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823) but did not receive treatment with Ranibizumab in that study or this extension study.
491553|NCT00379795|O2|Outcome|Ranibizumab Crossover Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were enrolled but did not initially receive Ranibizumab in Study FVF2428g (NCT00056823), Study FVF2587g (NCT00061594) or Study FVF2598g (NCT00056836) and then crossed over to receive Ranibizumab either in that initial study or this extension study.
491554|NCT00379795|O1|Outcome|Ranibizumab Initial Group|In this extension study participants received Ranibizumab injection 0.5 mg in a single-dose regimen given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Participants in this group were initially enrolled and received treatment with Ranibizumab in one of the following studies: FVF2428g (NCT00056823), FVF2587g (NCT00061594) or FVF2598g (NCT0056823).
491555|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
491556|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
491557|NCT00379795|O2|Outcome|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
491558|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
491559|NCT00379795|O4|Outcome|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
491560|NCT00379795|O3|Outcome|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2598g or this extension study.
491771|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
491562|NCT00379795|O1|Outcome|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
491563|NCT00379795|E4|Reported Event|Ranibizumab Treated PDT XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated PDT XO includes participants who received sham intravitreal injections in combination with photodynamic therapy in previous study FVF2428g or previous study FVF2587g before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g, previous study FVF2587g or this extension study.
491564|NCT00379795|E3|Reported Event|Ranibizumab Treated Sham XO|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Ranibizumab Treated Sham Crossover (XO) includes participants who received sham intravitreal injections before crossing over to receive ranibizumab 0.5 mg intravitreal injection in previous study FVF2428g or this extension study.
491565|NCT00379795|E2|Reported Event|Ranibizumab Treated Initial + PDT|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. This group includes participants who received ranibizumab 0.5 mg intravitreal injection in combination with photodynamic therapy in previous Study FVF2428g.
491566|NCT00379795|E1|Reported Event|Ranibizumab Treated Initial Mono|In this extension study participants received Ranibizumab intravitreal injection 0.5 mg in the study eye given on an as needed basis no more frequently than every 30 days (no more than 12 injections per year) for 24 months. Dosing interval was determined by the investigator, on the basis of clinical evaluations and judgment. Participants in this group previously received ranibizumab monotherapy (Mono), that is, ranibizumab 0.5 mg intravitreal injection alone in previous study FVF2598g or ranibizumab 0.5 mg intravitreal injection in combination with sham photodynamic therapy (PDT) in previous study FVF2587g.
491567|NCT00379769|B5|Baseline|Total|Total of all reporting groups
491568|NCT00379769|B4|Baseline|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491569|NCT00379769|B3|Baseline|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491570|NCT00379769|B2|Baseline|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491571|NCT00379769|B1|Baseline|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491572|NCT00379769|P6|Participant Flow|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491573|NCT00379769|P5|Participant Flow|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491574|NCT00379769|P4|Participant Flow|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491575|NCT00379769|P3|Participant Flow|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491576|NCT00379769|P2|Participant Flow|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491577|NCT00379769|P1|Participant Flow|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491578|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
492140|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
491579|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491580|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491581|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491582|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491583|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491584|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491585|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491586|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491587|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491588|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491589|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491590|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491591|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491592|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491593|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491594|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491595|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491596|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491597|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491598|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491599|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491772|NCT00379574|E1|Reported Event|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
491773|NCT00379353|B3|Baseline|Total|Total of all reporting groups
491600|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491601|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491602|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491603|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491604|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491605|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491606|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491607|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491608|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491609|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491610|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491611|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491612|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491613|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491614|NCT00379769|O2|Outcome|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491615|NCT00379769|O1|Outcome|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491616|NCT00379769|O2|Outcome|Combined MET/SU: Main Study and Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491617|NCT00379769|O1|Outcome|Combined RSG: Main Study and Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator’s discretion.
491618|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491619|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491774|NCT00379353|B2|Baseline|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491775|NCT00379353|B1|Baseline|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491620|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491621|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491622|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491623|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491624|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491625|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491626|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491627|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491628|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491629|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491630|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491631|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491632|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491633|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491776|NCT00379353|P2|Participant Flow|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491777|NCT00379353|P1|Participant Flow|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491634|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491635|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent
491636|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491637|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491638|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491639|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491640|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491641|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491642|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491643|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491644|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491645|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491646|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491647|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491648|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491649|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491650|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491651|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491652|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491778|NCT00379353|O4|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
493958|NCT00371462|B3|Baseline|Total|Total of all reporting groups
491653|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491654|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15mg per day or miconizied equivalent of 10.5mg per day; gliclazide 240mg per day and glimepiride 4mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491655|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491656|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491657|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491658|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491659|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491660|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491661|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491662|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or miconizied equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491663|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive RSG, in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491664|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491665|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491666|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491667|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491668|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491669|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491670|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491671|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491672|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491673|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491674|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491675|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491676|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491677|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491678|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491679|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491680|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491681|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491682|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491683|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491684|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491685|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491686|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491687|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491688|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491689|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491690|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491691|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491779|NCT00379353|O3|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
497909|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
491692|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491693|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491694|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491695|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491696|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491697|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491698|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491699|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491700|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491701|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491702|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491703|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491704|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491705|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491706|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491707|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491708|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491709|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491710|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491780|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days
491781|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days
491711|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491712|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491713|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491714|NCT00379769|O4|Outcome|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491715|NCT00379769|O3|Outcome|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491716|NCT00379769|O2|Outcome|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491717|NCT00379769|O1|Outcome|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491718|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491719|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491720|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491721|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491722|NCT00379769|O2|Outcome|Combined MET/SU|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, an SU (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent. Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491723|NCT00379769|O1|Outcome|Combined RSG|Participants inadequately controlled on background MET or background SU were randomised to receive RSG, in addition to MET or SU. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491724|NCT00379769|E6|Reported Event|Combined MET/SU: Observational Follow-up|Participants randomized to the active control groups (MET+SU and SU+MET) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491725|NCT00379769|E5|Reported Event|Combined RSG: Observational Follow-up|Participants randomized to receive RSG (MET+RSG and SU+RSG) in the main RECORD study. Participants were not provided with study medication in the observational follow-up; instead, anti-diabetic treatment was prescribed at the investigator's discretion.
491726|NCT00379769|E4|Reported Event|MET in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, MET. MET was gradually increased to the maximum permitted dose of 2550 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491727|NCT00379769|E3|Reported Event|RSG in Addition to Background SU|Participants inadequately controlled on background SU were randomised to receive, in addition to SU, RSG. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491728|NCT00379769|E2|Reported Event|SU in Addition to Background MET|Participants inadequately controlled on background MET were randomised to receive, in addition to MET, a sulfonylurea (SU) (glibenclamide, gliclazide, or glimepiride). The SU was gradually increased to the maximum permitted dose (glibenclamide 15 mg per day or micronized equivalent of 10.5 mg per day; gliclazide 240 mg per day; glimepiride 4 mg per day) as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491729|NCT00379769|E1|Reported Event|RSG in Addition to Background MET|Participants inadequately controlled on background metformin (MET) were randomised to receive rosiglitazone (RSG), in addition to MET. RSG was initiated as a 4 mg once daily dose and was increased to a maximum dose of 8 mg per day as required to achieve a target HbA1c of less than or equal to 7.0 percent.
491730|NCT00379639|B6|Baseline|Total|Total of all reporting groups
491731|NCT00379639|B5|Baseline|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491732|NCT00379639|B4|Baseline|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491733|NCT00379639|B3|Baseline|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491734|NCT00379639|B2|Baseline|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491735|NCT00379639|B1|Baseline|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491736|NCT00379639|P5|Participant Flow|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491737|NCT00379639|P4|Participant Flow|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491738|NCT00379639|P3|Participant Flow|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491739|NCT00379639|P2|Participant Flow|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491740|NCT00379639|P1|Participant Flow|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491741|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491742|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491743|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491744|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491745|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491746|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491747|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491748|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491749|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491750|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491751|NCT00379639|O5|Outcome|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491752|NCT00379639|O4|Outcome|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491753|NCT00379639|O3|Outcome|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491754|NCT00379639|O2|Outcome|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491755|NCT00379639|O1|Outcome|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491756|NCT00379639|E5|Reported Event|Dose Level 8|Participants received romidepsin 12 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491757|NCT00379639|E4|Reported Event|Dose Level 6|Participants received romidepsin 10 mg/m^2 plus gemcitabine 1000 mg/m^2 on Days 1 and 15 every 28 days.
491758|NCT00379639|E3|Reported Event|Dose Level 5|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1 and 15 every 28 days.
491759|NCT00379639|E2|Reported Event|Dose Level 2|Participants received romidepsin 7 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491760|NCT00379639|E1|Reported Event|Dose Level 1|Participants received romidepsin 10 mg/m^2 plus gemcitabine 800 mg/m^2 on Days 1, 8, and 15 every 28 days.
491761|NCT00379587|B1|Baseline|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491762|NCT00379587|P1|Participant Flow|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491763|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491764|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491765|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491766|NCT00379587|O1|Outcome|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491767|NCT00379587|E1|Reported Event|Rituxan (Rituximab)|375mg/m^2 IV at 3, 6, 9 and 12 months from transplantation
491768|NCT00379574|B1|Baseline|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
491769|NCT00379574|P1|Participant Flow|Bortezomib + CHOP Every 2 Weeks|"Phase I Bortezomib 1.0, 1/3, and 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5~Phase II Bortezomib 1.6 mg/m2 CHOP,every 2 weeks cyclophosphamide 750 mg/m2 D1 doxorubicin 50 mg/m2 D1 vincristine 1.4 mg/m2 D1 prednisone 100 mg D1-D5"
491770|NCT00379574|O1|Outcome|Bortezomib + CHOP Every 2 Weeks|CHOP; cyclophosphamide, doxorubicin, vincristine, and prednisone
491786|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491787|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491788|NCT00379353|O6|Outcome|Placebo (Day 29)|Two placebo capsules orally, once a day for 14 days.
491789|NCT00379353|O5|Outcome|Placebo (Day 15)|Two placebo capsules orally, once a day for 14 days.
491790|NCT00379353|O4|Outcome|Placebo (Baseline)|Two placebo capsules orally, once a day for 14 days.
491791|NCT00379353|O3|Outcome|Thalidomide (Day 29)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491792|NCT00379353|O2|Outcome|Thalidomide (Day 15)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491793|NCT00379353|O1|Outcome|Thalidomide (Baseline)|Thalidomide 100 mg capsules orally, once a day for 14 days.
491794|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491795|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491796|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491797|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491798|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491799|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491800|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491801|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491802|NCT00379353|O2|Outcome|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491803|NCT00379353|O1|Outcome|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491804|NCT00379353|E2|Reported Event|Group 2: Placebo|Two placebo capsules orally, once a day for 14 days.
491805|NCT00379353|E1|Reported Event|Group 1: Thalidomide|100 mg capsules orally, once a day for 14 days
491806|NCT00379288|B5|Baseline|Total|Total of all reporting groups
491807|NCT00379288|B4|Baseline|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
491808|NCT00379288|B3|Baseline|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
491809|NCT00379288|B2|Baseline|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491810|NCT00379288|B1|Baseline|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491811|NCT00379288|P4|Participant Flow|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
491812|NCT00379288|P3|Participant Flow|F/SC 250/50 mcg BID|fluticasone/salmeterol combination (F/SC) 250/50 twice daily for 1 year
491813|NCT00379288|P2|Participant Flow|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491814|NCT00379288|P1|Participant Flow|MF/F 200/10 mcg BID|mometasone furoate/formoterol (MF/F) 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491815|NCT00379288|O4|Outcome|F/SC 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
491816|NCT00379288|O3|Outcome|F/SC 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
491817|NCT00379288|O2|Outcome|MF/F 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491818|NCT00379288|O1|Outcome|MF/F 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491819|NCT00379288|E4|Reported Event|F/SC MDI 500/50 mcg BID|F/SC 500/50 twice daily for 1 year
491820|NCT00379288|E3|Reported Event|F/SC MDI 250/50 mcg BID|F/SC 250/50 twice daily for 1 year
491821|NCT00379288|E2|Reported Event|MF/F MDI 400/10 mcg BID|MF/F 400/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491822|NCT00379288|E1|Reported Event|MF/F MDI 200/10 mcg BID|MF/F 200/10 mcg via a metered dose inhaler (MDI) twice daily for 1 year
491823|NCT00379236|B3|Baseline|Total|Total of all reporting groups
491824|NCT00379236|B2|Baseline|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491825|NCT00379236|B1|Baseline|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491826|NCT00379236|P3|Participant Flow|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491827|NCT00379236|P2|Participant Flow|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491828|NCT00379236|P1|Participant Flow|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491829|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491830|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491831|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491857|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491832|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491833|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491834|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491835|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491836|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491837|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491838|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491839|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491840|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491841|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491842|NCT00379236|O1|Outcome|EUFLEXXA™ Double Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491843|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491844|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491845|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491846|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491847|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491848|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491849|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491850|NCT00379236|O1|Outcome|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491851|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491852|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491853|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491854|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491855|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491856|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
492282|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
491858|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491859|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491860|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491861|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491862|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491863|NCT00379236|O2|Outcome|Placebo Double-Blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491864|NCT00379236|O1|Outcome|EUFLEXXA™ Double-Blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491865|NCT00379236|O2|Outcome|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491866|NCT00379236|O1|Outcome|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491867|NCT00379236|E3|Reported Event|EUFLEXXA™ Extension Study|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 26, 27 and 28. Patients were followed for 26 additional weeks (to week 52) following the first injection.
491868|NCT00379236|E2|Reported Event|Placebo Double-blind|Each subject received 3 single-dose injections of placebo into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491869|NCT00379236|E1|Reported Event|EUFLEXXA™ Double-blind|Each subject received 3 single-dose injections of EUFLEXXA™ (20 milligram/2 milliliter 1 percent sodium hyaluronate) into the target knee; one injection per week at weeks 0, 1 and 2. Patients were followed for 26 weeks following the first injection.
491870|NCT00379210|B3|Baseline|Total|Total of all reporting groups
491871|NCT00379210|B2|Baseline|Nutrition Education Group|Nutrition education group - received information about nutrition
491872|NCT00379210|B1|Baseline|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
491873|NCT00379210|P2|Participant Flow|Nutrition Education Group|Nutrition education group - received information about nutrition
491874|NCT00379210|P1|Participant Flow|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
491875|NCT00379210|O2|Outcome|Nutrition Education Group|Nutrition education group - received information about nutrition
491876|NCT00379210|O1|Outcome|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
491877|NCT00379210|E2|Reported Event|Nutrition Education Group|Nutrition education group - received information about nutrition
491878|NCT00379210|E1|Reported Event|Mindfulness Training Group|Meditation training group-- received Mindfulness Based Stress Management from the Penn Program for Stress Management
491879|NCT00378703|B5|Baseline|Total|Total of all reporting groups
491880|NCT00378703|B4|Baseline|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
491881|NCT00378703|B3|Baseline|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
491882|NCT00378703|B2|Baseline|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
491883|NCT00378703|B1|Baseline|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
491884|NCT00378703|P4|Participant Flow|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
491885|NCT00378703|P3|Participant Flow|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
491886|NCT00378703|P2|Participant Flow|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
491887|NCT00378703|P1|Participant Flow|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
491888|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
491889|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
491890|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
491891|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
491892|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
491893|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
491894|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
491895|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
491896|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
491897|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
491898|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
491899|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
491900|NCT00378703|O4|Outcome|Arm D (Sorafenib and Temsirolimus)|"Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.~Sorafenib: Given PO~temsirolimus: Given IV"
491901|NCT00378703|O3|Outcome|Arm C (Bevacizumab and Sorafenib)|"Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.~Sorafenib: Given PO~bevacizumab: Given IV"
491902|NCT00378703|O2|Outcome|Arm B (Bevacizumab and Temsirolimus)|"Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.~temsirolimus: Given IV~bevacizumab: Given IV"
491903|NCT00378703|O1|Outcome|Arm A (Bevacizumab)|"Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.~bevacizumab: Given IV"
491904|NCT00378703|E4|Reported Event|Arm D (Sorafenib and Temsirolimus)|Patients receive sorafenib 200 mg PO BID on days 1-28 and temsirolimus as in Arm B in a 28-day cycle.
491905|NCT00378703|E3|Reported Event|Arm C (Bevacizumab and Sorafenib)|Patients receive bevacizumab 5 mg/kg IV over 30-90 minutes on days 1 and 15 and sorafenib 200 mg PO BID on days 1-5, 8-12, 15-19, and 22-26 in a 28-day cycle.
491906|NCT00378703|E2|Reported Event|Arm B (Bevacizumab and Temsirolimus)|Patients receive temsirolimus 25 mg IV over 30 minutes on days 1, 8, 15, and 22 and bevacizumab as in Arm A in a 28-day cycle.
491907|NCT00378703|E1|Reported Event|Arm A (Bevacizumab)|Patients receive bevacizumab 10 mg/kg IV over 30-90 minutes on days 1 and 15 in a 28-day cycle.
491908|NCT00378599|B1|Baseline|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
491909|NCT00378599|P1|Participant Flow|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
491910|NCT00378599|O1|Outcome|PEG-Intron Plus Ribavirin|PEG-Intron plus ribavirin treatment for up to 48 weeks with 24-week follow up
491911|NCT00378599|E1|Reported Event|Pegylated Interferon Alfa-2b and Ribavirin|
491912|NCT00378573|B1|Baseline|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491913|NCT00378573|P1|Participant Flow|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491914|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491915|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491916|NCT00378573|O1|Outcome|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491917|NCT00378573|E1|Reported Event|Docetaxel, Gemcitabine and Bevacizumab|Combination therapy administered as follows: gemcitabine 1000 mg/m2 IV over 0.5 hour on Days 1 and 8; docetaxel 75 mg/m2 IV over 1 hour on Day 8; and bevacizumab 15 mg/kg IV on Day 1. Maintenance bevacizumab therapy was administered as 15 mg/kg IV on Day 1.
491918|NCT00378560|B3|Baseline|Total|Total of all reporting groups
491919|NCT00378560|B2|Baseline|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491920|NCT00378560|B1|Baseline|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491921|NCT00378560|P2|Participant Flow|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491922|NCT00378560|P1|Participant Flow|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491923|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491924|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
492283|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
491925|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491926|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491927|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491928|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491929|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491930|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491931|NCT00378560|O2|Outcome|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491932|NCT00378560|O1|Outcome|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491933|NCT00378560|E2|Reported Event|Placebo|Placebo 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491934|NCT00378560|E1|Reported Event|V501|V501; Gardasil, 0.5 mL intramuscular injection, in 3 dosing regimen, given at Day 1, Month 2, and Month 6
491935|NCT00378534|B1|Baseline|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
491936|NCT00378534|P1|Participant Flow|CD34 Selection|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
491937|NCT00378534|O1|Outcome|Hematologic Survival Using Miltenyi Reagent System|Subjects with hematological malignancies receiving a myeloablative conditioning regimen of cyclophosphamide, fludarabine and total body irradiation followed by an infusion of stem cell product prepared using the Miltenyi CliniMacs system for CD34 selection and a delayed T cell depletion add back as donor lymphocyte infucion at day 90. The subjects receiveing allogeneic stem cell transplantation will have stem cell product prepared using Miltenyi CliniMacs system to determine the overall survival and non-relapse at day +200.
491938|NCT00378534|E1|Reported Event|Transplant Recipients|"T cell depletion~Miltenyi Clinimax CD34 Reagent System: T cell depletion"
491939|NCT00378508|B3|Baseline|Total|Total of all reporting groups
491940|NCT00378508|B2|Baseline|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491941|NCT00378508|B1|Baseline|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491942|NCT00378508|P2|Participant Flow|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491943|NCT00378508|P1|Participant Flow|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491944|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491945|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491946|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491947|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491948|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491949|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491950|NCT00378508|O2|Outcome|Saline Infusion (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491951|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491952|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491953|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491954|NCT00378508|O2|Outcome|Saline Infusions (Placebo)|The course of normal saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491955|NCT00378508|O1|Outcome|Teplizumab Infusions (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491956|NCT00378508|E2|Reported Event|Teplizumab Infusion (Active)|The course of teplizumab infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491957|NCT00378508|E1|Reported Event|Saline Infusions (Placebo)|The course of a saline infusion comprises daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 of 826 µg/m2 over a 14 day treatment period.
491958|NCT00378378|B4|Baseline|Total|Total of all reporting groups
491959|NCT00378378|B3|Baseline|Pooled Placebo|All placebo groups were combined
491960|NCT00378378|B2|Baseline|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
491961|NCT00378378|B1|Baseline|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
491962|NCT00378378|P3|Participant Flow|Pooled Placebo|All placebo groups were combined
491963|NCT00378378|P2|Participant Flow|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
491964|NCT00378378|P1|Participant Flow|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
491965|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
491966|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
491967|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
491968|NCT00378378|O3|Outcome|Pooled Placebo|All placebo groups were combined
491969|NCT00378378|O2|Outcome|MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years|Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
491970|NCT00378378|O1|Outcome|MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years|Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
491971|NCT00378378|E3|Reported Event|Placebo|
491972|NCT00378378|E2|Reported Event|MFNS 100 or 200 mcg BID|
491973|NCT00378378|E1|Reported Event|MFNS 100 or 200 mcg QD|
491974|NCT00378326|B1|Baseline|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
491975|NCT00378326|P1|Participant Flow|Tacrolimus|Tacrolimus at doses of 0.15- 0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
491976|NCT00378326|O1|Outcome|Tacrolimus|Tacrolimus at doses of 0.15-0.3mg/kg/day in two divided oral doses, in conjunction with, initially, up to 60mg/day of oral prednisone
491977|NCT00378326|O2|Outcome|Post-treatment|White blood cell (WBC) count in CSF post-treatment
491978|NCT00378326|O1|Outcome|Pre-treatment|White blood cell (WBC) count in CSF pre-treatment
491979|NCT00378326|E1|Reported Event|All Patients|All patients enrolled
491980|NCT00378209|B1|Baseline|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491981|NCT00378209|P1|Participant Flow|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491982|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|
491983|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491984|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
492012|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492013|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492273|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
491985|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491986|NCT00378209|O1|Outcome|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491987|NCT00378209|E1|Reported Event|Lenalidomide, Dexamethasone, Bortezomib Combination|"Patients were treated for up to 8 21-day cycles with the combination of bortezomib 1.0 mg/m2 IV, days 1, 4, 8, and 11, and oral lenalidomide 15 mg/day, days 1 through 14, with oral dexamethasone 40 mg/day (cycles 1-4) and 20 mg/day (cycles 5-8) on the days of and days after bortezomib dosing (days 1, 2, 4, 5, 8, 9, 11, and 12).Following a protocol amendment , dexamethasone dosing was reduced to 20 mg/day in cycles 1 through 4 and 10 mg/day in cycles 5 through 8.~Beyond cycle 8, responding patients and those with stable disease (SD) could receive maintenance therapy until disease progression or unacceptable toxicity. Maintenance therapy comprised bortezomib and lenalidomide at the doses tolerated on completion of cycle 8, with lenalidomide on days 1 through 14 and using an amended schedule of weekly bortezomib (days 1 and 8) and dexamethasone 10 mg on days 1, 2, 8, and 9."
491988|NCT00378105|B3|Baseline|Total|Total of all reporting groups
491989|NCT00378105|B2|Baseline|Phase 2 Population|
491990|NCT00378105|B1|Baseline|Phase 1 Population|
491991|NCT00378105|P2|Participant Flow|Phase 2 Pupulation|Each subject received the maximum planned dose of 1.3 mg/m2/IV bortezomib daily Days 1, 4, 8 and 11 followed by a 10-day rest period, 20 mg PO dexamethasone single daily oral dose Days 1, 2, 4, 5, 8, 9, 11, 12 and25 mg/PO/QD (every day)lenalidomide daily Days 1-14 followed by 7-day rest every 21 days x 4 cycles and then at 10 mg/day on the same schedule for cycles 5 – 8. Each cycle of treatment consisted of 21 days.
491992|NCT00378105|P1|Participant Flow|Phase 1 Population|"Four levels of dose were evaluated and a standard 3+3 dose escalation schema was used to determine the MTD and additional patients were evaluated on the MTD level.~Level 1 1 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 2 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 15 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 3 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 20 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days~Level 4 1.3 mg/m2/IV bortezomib daily Days 1,4, 8 and 11 40 mg PO dexamethasone daily Days 1, 2, 4, 5, 8, 9, 11, 12 and 25 mg/PO/day lenalidomide daily Days 1-14 followed by 7-day rest every 21 days"
491993|NCT00378105|O1|Outcome|All Patients|
491994|NCT00378105|O1|Outcome|All Patients|
491995|NCT00378105|O1|Outcome|All Patients|
491996|NCT00378105|O3|Outcome|Total|
491997|NCT00378105|O2|Outcome|Phase II Population|
491998|NCT00378105|O1|Outcome|Phase 1 Population|
491999|NCT00378105|E1|Reported Event|All Patients|
492000|NCT00378079|B4|Baseline|Total|Total of all reporting groups
492001|NCT00378079|B3|Baseline|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492002|NCT00378079|B2|Baseline|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492003|NCT00378079|B1|Baseline|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492004|NCT00378079|P3|Participant Flow|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492005|NCT00378079|P2|Participant Flow|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492006|NCT00378079|P1|Participant Flow|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492007|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492008|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492009|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492010|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492011|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492137|NCT00377832|O2|Outcome|Acetaminophen 975 mg Once|
492138|NCT00377832|O1|Outcome|No Medication|
492014|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492015|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492016|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492017|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492018|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492019|NCT00378079|O3|Outcome|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492020|NCT00378079|O2|Outcome|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492021|NCT00378079|O1|Outcome|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492022|NCT00378079|E3|Reported Event|3 Counseling and Methadone Maintenance in Prison, With Continu|Counseling + Methadone : Counseling and methadone maintenance in prison, with opportunity to continue that treatment upon release
492023|NCT00378079|E2|Reported Event|2 Counseling Only in Prison, With Initiation of Methadone Main|Counseling + Transfer : Counseling only in prison, with opportunity to enter methadone maintenance upon release
492024|NCT00378079|E1|Reported Event|1 Counseling Only in Prison|Counseling Only : Counseling only in prison, with passive referral to drug abuse treatment upon release
492025|NCT00378014|B3|Baseline|Total|Total of all reporting groups
492026|NCT00378014|B2|Baseline|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492027|NCT00378014|B1|Baseline|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492028|NCT00378014|P2|Participant Flow|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492029|NCT00378014|P1|Participant Flow|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492030|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492031|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492032|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492033|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492034|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492035|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492036|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492037|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492038|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492039|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492040|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492041|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492042|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492043|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492044|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492045|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492046|NCT00378014|O2|Outcome|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492047|NCT00378014|O1|Outcome|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492139|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492048|NCT00378014|E4|Reported Event|Extension Period - CNI|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492049|NCT00378014|E3|Reported Event|Extension Period - Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492050|NCT00378014|E2|Reported Event|Calcineurin Inhibitor (CNI)|Basiliximab plus CNI-based immunosuppressive regimen according to local best practice plus optional steroids according to local best practice
492051|NCT00378014|E1|Reported Event|Everolimus|Basiliximab plus everolimus-based immunosuppressive regimen following the reduction and cessation of initial CNI regimen plus optional steroids according to local best practice
492052|NCT00377962|B3|Baseline|Total|Total of all reporting groups
492053|NCT00377962|B2|Baseline|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492054|NCT00377962|B1|Baseline|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492055|NCT00377962|P2|Participant Flow|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492056|NCT00377962|P1|Participant Flow|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492057|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492058|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492059|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492060|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492061|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492062|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492063|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492064|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492065|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492066|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492067|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492068|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492069|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492070|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492071|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492072|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492073|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492074|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492075|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492076|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492077|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492078|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492079|NCT00377962|O2|Outcome|Control|CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice.
492080|NCT00377962|O1|Outcome|Everolimus + CNI Reduction|Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%,upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice
492081|NCT00377962|E8|Reported Event|Everolimus + CNI Reduction: 24 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
492082|NCT00377962|E7|Reported Event|Control: 24 Month Lung|"Subgroup of Control group with lung patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
492083|NCT00377962|E6|Reported Event|Everolimus + CNI Reduction: 24 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 24 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
492084|NCT00377962|E5|Reported Event|Control: 24 Month Heart|"Subgroup of Control group with heart patients at 24 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
492085|NCT00377962|E4|Reported Event|Everolimus+CNI Reduction: 12 Month Lung|"Subgroup of everolimus + CNI reduction group with lung patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
492086|NCT00377962|E3|Reported Event|Control: 12 Month Lung|"Subgroup of control group with lung patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
492087|NCT00377962|E2|Reported Event|Everolimus + CNI Reduction: 12 Month Heart|"Subgroup of everolimus + CNI reduction group with heart patients at 12 months. Everolimus (3-8 ng/mL) + CNI reduction ± MPA/AZA ± steroids. Everolimus 0.75-1.5 mg twice daily. Dose adjusted to target blood concentration in the range 3-8 ng/mL. CNI reduction (reduced 50-70%): target of achieving a cyclosporine A (CsA) trough level < 75 ng/mL or a tacrolimus trough level < 4 ng/mL. MPA was reduced by 25%, upon CNI reduction. If participants were treated with AZA ( alternative to MPA) no dose reduction was needed. Steroid treatment was according to local practice."
492088|NCT00377962|E1|Reported Event|Control: 12 Month Heart|"Subgroup of Control group with heart patients at 12 months. CNI ± MPA/AZA ± steroids. In the standard CNI arm, all immunosuppressants including mycophenolic acid (MPA) and azathioprine (AZA) continued unchanged as per local practice. Steroid treatment was according to local practice."
492089|NCT00377858|B3|Baseline|Total|Total of all reporting groups
492090|NCT00377858|B2|Baseline|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492091|NCT00377858|B1|Baseline|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492092|NCT00377858|P2|Participant Flow|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492093|NCT00377858|P1|Participant Flow|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492094|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492095|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492096|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492097|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492098|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492099|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492100|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492101|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492102|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492103|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492104|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492105|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492106|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492107|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492108|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492109|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492110|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492111|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492112|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492113|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492114|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492115|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492116|NCT00377858|O2|Outcome|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492117|NCT00377858|O1|Outcome|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492118|NCT00377858|E2|Reported Event|Insulin Glargine|Insulin glargine daily with insulin lispro at mealtime (up to 3 injections) as needed.
492119|NCT00377858|E1|Reported Event|Insulin Lispro Mid Mixture|Insulin lispro mid mixture (MM) up to three times a day (TID)
492120|NCT00377832|B3|Baseline|Total|Total of all reporting groups
492121|NCT00377832|B2|Baseline|Acetaminophen 975 mg Once|
492122|NCT00377832|B1|Baseline|No Medication|
492123|NCT00377832|P2|Participant Flow|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492124|NCT00377832|P1|Participant Flow|In Labor With a Fever Will Give no Medication|
492125|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492126|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
492127|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492128|NCT00377832|O1|Outcome|In Labor With a Fever Will Get no Medication|
492129|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492130|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
492131|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492132|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
492133|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492134|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
492135|NCT00377832|O2|Outcome|In Labor With a Fever Will Get Acetaminophen 975 mg Orallyonce|
492136|NCT00377832|O1|Outcome|In Labor With a Fever Will Give no Medication|
492141|NCT00377832|E2|Reported Event|Acetaminophen 975 mg Once|In labor, fever is identified, consent and randomization occurs, then acetaminophen is given.
492142|NCT00377832|E1|Reported Event|No Medication|In labor, fever is identified, consent and randomization occurs, then no medication is given.
492143|NCT00377819|B3|Baseline|Total|Total of all reporting groups
492144|NCT00377819|B2|Baseline|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
492145|NCT00377819|B1|Baseline|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
492146|NCT00377819|P2|Participant Flow|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
492147|NCT00377819|P1|Participant Flow|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
492148|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
492149|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
492150|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
492151|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
492152|NCT00377819|O2|Outcome|Denosumab 60 mg Q6M|60 mg denosumab administered subcutaneously once every 6 months (Q6M) plus placebo for alendronate once weekly (QW) orally
492153|NCT00377819|O1|Outcome|Alendronate 70 mg QW|70 mg alendronate once weekly (QW) orally plus placebo for denosumab subcutaneously once every 6 months (Q6M)
492154|NCT00377819|E2|Reported Event|Denosumab 60 mg Q6M|
492155|NCT00377819|E1|Reported Event|Alendronate 70 mg QW|
492156|NCT00377741|B3|Baseline|Total|Total of all reporting groups
492157|NCT00377741|B2|Baseline|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492158|NCT00377741|B1|Baseline|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492159|NCT00377741|P2|Participant Flow|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492160|NCT00377741|P1|Participant Flow|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492161|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492162|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492163|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492164|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492165|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492166|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492167|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492168|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492169|NCT00377741|O2|Outcome|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492170|NCT00377741|O1|Outcome|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492171|NCT00377741|E2|Reported Event|Non-Cystic Fibrosis (Non-CF)|Participants with non-cystic fibrosis (Non-CF) received a single oral dose of valganciclovir 900 mg
492172|NCT00377741|E1|Reported Event|Cystic Fibrosis (CF)|Participants with cystic fibrosis (CF) received a single oral dose of valganciclovir 900 mg
492173|NCT00377676|B3|Baseline|Total|Total of all reporting groups
492174|NCT00377676|B2|Baseline|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492175|NCT00377676|B1|Baseline|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492176|NCT00377676|P2|Participant Flow|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492177|NCT00377676|P1|Participant Flow|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492178|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492284|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492179|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492180|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492181|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492182|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492183|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492184|NCT00377676|O2|Outcome|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492185|NCT00377676|O1|Outcome|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492186|NCT00377676|E2|Reported Event|Placebo|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (1 placebo tablet). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492187|NCT00377676|E1|Reported Event|Cycloset|During the first week of the dose titration period, subjects were instructed to take 1 tablet of study drug daily (0.8 mg Cycloset). If the dose was tolerated, subjects were to have their dose of study drug increased to 2 tablets of study drug per day. The daily dose of study drug was to be increased at a rate of 1 tablet per week, up to a target dose level of 6 tablets per day at Week 6.
492188|NCT00377637|B5|Baseline|Total|Total of all reporting groups
492189|NCT00377637|B4|Baseline|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492190|NCT00377637|B3|Baseline|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492191|NCT00377637|B2|Baseline|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492192|NCT00377637|B1|Baseline|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492193|NCT00377637|P4|Participant Flow|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492194|NCT00377637|P3|Participant Flow|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492195|NCT00377637|P2|Participant Flow|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492196|NCT00377637|P1|Participant Flow|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492197|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492198|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492199|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492200|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492201|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492202|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492203|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492204|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492205|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2.0 mg/kg/day along with placebo matching MMF (1.0 g BID), plus corticosteroid for 36 months of therapy
492206|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g twice daily (BID) along with placebo matching AZA (2.0 mg/kg/day), plus corticosteroid, until 36 months of therapy.
492207|NCT00377637|O2|Outcome|Azathioprine (AZA)|Azathioprine (AZA) 2 mg/kg/day orally once a day + Placebo to MMF orally twice a day + Corticosteroid for 36 months.
492208|NCT00377637|O1|Outcome|Mycophenolate Mofetil (MMF)|Mycophenolate mofetil (MMF) 1.0 g orally twice a day + Placebo to Azathioprine orally once a day + Corticosteroid for 36 months
492209|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492210|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492211|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492212|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492213|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492214|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492215|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492216|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492217|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492218|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492219|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492220|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492221|NCT00377637|O2|Outcome|Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492222|NCT00377637|O1|Outcome|Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492223|NCT00377637|O2|Outcome|Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492224|NCT00377637|O1|Outcome|Intravenous Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492225|NCT00377637|E4|Reported Event|Maintenance Phase: Azathioprine|Participants who responded to Induction Phase treatment received azathioprine (AZA) 2 mg/kg/day orally once a day, placebo to mycophenolate mofetil orally twice a day and corticosteroid for the 36 weeks Maintenance Phase.
492226|NCT00377637|E3|Reported Event|Maintenance Phase: Mycophenolate Mofetil|Participants who responded to Induction Phase treatment received mycophenolate mofetil (MMF) 1.0 g orally twice a day, placebo to azathioprine orally once a day and corticosteroid for the 36 weeks Maintenance Phase.
492227|NCT00377637|E2|Reported Event|Induction Phase: Mycophenolate Mofetil|Participants received oral mycophenolate mofetil (MMF) 1.5 g twice a day and concomitant corticosteroids for the 24-weeks of the Induction Phase.
492228|NCT00377637|E1|Reported Event|Induction Phase: Cyclophosphamide|Participants received monthly intravenous infusions of cyclophosphamide, 0.5 to 1.0 g per square meter of body surface area and concomitant treatment with corticosteroids for the 24 week Induction Phase.
492229|NCT00377572|B3|Baseline|Total|Total of all reporting groups
492230|NCT00377572|B2|Baseline|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492274|NCT00377520|E1|Reported Event|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
492231|NCT00377572|B1|Baseline|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492232|NCT00377572|P2|Participant Flow|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492233|NCT00377572|P1|Participant Flow|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total immunoglobulin E (IgE) level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492234|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492235|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492236|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492237|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492238|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492239|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492240|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492241|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492242|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492243|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492275|NCT00377455|B1|Baseline|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
492276|NCT00377455|P1|Participant Flow|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
492277|NCT00377455|O1|Outcome|Bosentan/Placebo|Outcomes not available, due to early termination of study
492244|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492245|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492246|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492247|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492248|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492249|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492250|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492251|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492252|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492253|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492254|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492255|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492256|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492278|NCT00377455|E1|Reported Event|Bosentan and Placebo Arms|This group consists of subjects on both arms of the study - bosentan and placebo
492279|NCT00377429|B1|Baseline|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492280|NCT00377429|P1|Participant Flow|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492281|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492257|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492258|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492259|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492260|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492261|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492262|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492263|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492264|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492265|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492266|NCT00377572|O2|Outcome|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492267|NCT00377572|O1|Outcome|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492268|NCT00377572|E2|Reported Event|Placebo + Conventional Therapy|Placebo was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492269|NCT00377572|E1|Reported Event|Omalizumab (Xolair) + Conventional Therapy|Omalizumab was administered subcutaneously every 2 or 4 weeks over a period of 60 weeks to participants classified as having moderate to severe asthma. Doses (mg) and dosing frequency were determined by serum total IgE level (IU/mL) and body weight (kg). Also, participants continued with their conventional asthma therapy according to the National Asthma Education and Prevention Program (NAEPP-II, 2002) guidelines, under the management of an asthma specialist health care provider.
492270|NCT00377520|B1|Baseline|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
492271|NCT00377520|P1|Participant Flow|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
492272|NCT00377520|O1|Outcome|Pemetrexed|900 mg/m2, intravenous (IV), every 21 days, until disease progression
498297|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
492285|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492286|NCT00377429|O1|Outcome|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492287|NCT00377429|E1|Reported Event|Catumaxomab|4 dose series (10-20-50-150 micrograms) within 21 days
492288|NCT00377403|B3|Baseline|Total|Total of all reporting groups
492289|NCT00377403|B2|Baseline|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
492290|NCT00377403|B1|Baseline|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
492291|NCT00377403|P2|Participant Flow|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
492292|NCT00377403|P1|Participant Flow|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
492293|NCT00377403|O2|Outcome|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
492294|NCT00377403|O1|Outcome|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
492295|NCT00377403|E2|Reported Event|Symptomatic Treatments Only|Placebo for 10 days in addition to symptomatic treatments
492296|NCT00377403|E1|Reported Event|Intervention Arm|Amoxicillin 500mg tid for 10 days in addition to symptomatic treatments
492297|NCT00377364|B3|Baseline|Total|Total of all reporting groups
492298|NCT00377364|B2|Baseline|Placebo|Matching Placebo.
492299|NCT00377364|B1|Baseline|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
492300|NCT00377364|P2|Participant Flow|Placebo|Matching Placebo.
492301|NCT00377364|P1|Participant Flow|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
492302|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492303|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492304|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492305|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492306|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492307|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
492308|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492309|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492310|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492311|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
492312|NCT00377364|O2|Outcome|Placebo|Matching placebo.
492313|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492314|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492315|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492316|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492317|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492318|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492319|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492320|NCT00377364|O2|Outcome|Placebo|Matching Placebo.
492321|NCT00377364|O1|Outcome|Acetaminophen|OTC pain reliever and fever reducer that may have neuroprotective effects.
492322|NCT00377364|E2|Reported Event|Placebo|Matching Placebo.
492323|NCT00377364|E1|Reported Event|Acetaminophen|OTC pain reliever.fever reducer that may have neuroprotective effects.
492324|NCT00377312|B3|Baseline|Total|Total of all reporting groups
492325|NCT00377312|B2|Baseline|Parathyroid Hormone(1-34) - 4 Picomoles/kg/hr|Subjects received Parathyroid Hormone (1-34)intravenously at 4 picomoles/kg/hr.
492326|NCT00377312|B1|Baseline|Parathyroid Hormone - 2 Picomoles/kg/hr.|Subjects initially entering the study receive study drug Parathyroid Hormone (1-34) in intravenous doses beginning at 2 picomoles/kg/hr. Doses will be slowly and safely escalated in groups of 3 subjects.
492327|NCT00377312|P2|Participant Flow|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
492328|NCT00377312|P1|Participant Flow|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
492329|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492330|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492331|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492332|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492333|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492334|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492335|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492336|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492337|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492338|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492339|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492340|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492341|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492342|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492343|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492344|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492345|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492346|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492347|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492348|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492349|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492350|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492351|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492352|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492353|NCT00377312|O2|Outcome|Group 2|PTH(1-34) 4 picomoles/kg/hr for one week
492354|NCT00377312|O1|Outcome|Group 1|PTH(1-34) 2 picomols (pmols)/kg/hr
492355|NCT00377312|E2|Reported Event|Group 2|PTH (1-34) 4 picomoles (pmols)/kg/hr
492356|NCT00377312|E1|Reported Event|Group 1|PTH (1-34) 2 picomoles (pmols)/kg/hr
492357|NCT00377299|B3|Baseline|Total|Total of all reporting groups
492358|NCT00377299|B2|Baseline|Placebo|
492359|NCT00377299|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492360|NCT00377299|P2|Participant Flow|Placebo|Placebo identical in appearance to the medication was given beginning at one tablet with an increase to two tablets at week 2, three tablets at week 4 and four tablets at week 6. Patients remained on four tables throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
492361|NCT00377299|P1|Participant Flow|Citicoline|Citicoline add-on therapy was given beginning at one tablet(500mg/day) with an increase to two tablets(1000mg/day) at week 2, three tablets(1500mg/day)at week 4 and four tablets (2000mg/day) at week 6. Patients remained on 2000mg/day throughout the remaining weeks of the study (week 12). Doses were decreased, if needed, due to side effects.
492362|NCT00377299|O2|Outcome|Placebo|Placebo.
492363|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492364|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
492365|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492366|NCT00377299|O2|Outcome|Placebo|Placebo matching Citicoline.
492367|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492368|NCT00377299|O2|Outcome|Placebo|Placebo.
492369|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492370|NCT00377299|O2|Outcome|Placebo|Placebo.
492371|NCT00377299|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492372|NCT00377299|E2|Reported Event|Placebo|
492373|NCT00377299|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
492374|NCT00377260|B3|Baseline|Total|Total of all reporting groups
492375|NCT00377260|B2|Baseline|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492376|NCT00377260|B1|Baseline|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492377|NCT00377260|P2|Participant Flow|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492378|NCT00377260|P1|Participant Flow|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492379|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492380|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492381|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492382|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492383|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492384|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492385|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492386|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492387|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492388|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492389|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492390|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492391|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492392|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492393|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492394|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492395|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492396|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492397|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492398|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492399|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492400|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492401|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492402|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492403|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492404|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492405|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492406|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492407|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492408|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492409|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492410|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492411|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492412|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492413|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492414|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492415|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492416|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492417|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492418|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492419|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492420|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492421|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492422|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492423|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492424|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492425|NCT00377260|O2|Outcome|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492426|NCT00377260|O1|Outcome|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492427|NCT00377260|E2|Reported Event|Placebo|Reconstituted placebo in 2 divided doses for 10 days.
492428|NCT00377260|E1|Reported Event|Amoxicillin-Clavulanate|Reconstituted amoxicillin-clavulanate at 90/6.4 mg/kg/day in 2 divided doses for 10 days.
492429|NCT00377234|B3|Baseline|Total|Total of all reporting groups
492430|NCT00377234|B2|Baseline|Sequence B|Risedronate followed by ibandronate
492431|NCT00377234|B1|Baseline|Sequence A|Ibandronate followed by risedronate
492432|NCT00377234|P2|Participant Flow|Sequence B|Risedronate followed by ibandronate
492433|NCT00377234|P1|Participant Flow|Sequence A|Ibandronate followed by risedronate
492434|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
492435|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
492436|NCT00377234|O2|Outcome|Sequence B|risedronate followed by ibandronate
492437|NCT00377234|O1|Outcome|Sequence A|ibandronate followed by risedronate
492438|NCT00377234|O2|Outcome|Risedronate|While being treated with risendronate
492439|NCT00377234|O1|Outcome|Ibandronate|While being treated with ibandronate
492440|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
492441|NCT00377234|O2|Outcome|During Sequence B|Risedronate followed by ibandronate
492442|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
492443|NCT00377234|O3|Outcome|Total|During period 1 + during period 2
492444|NCT00377234|O2|Outcome|During Sequence B|Risendronate followed by ibandronate
492445|NCT00377234|O1|Outcome|During Sequence A|Ibandronate followed by risedronate
492446|NCT00377234|E2|Reported Event|Risedronate|Risendronate adverse events
492447|NCT00377234|E1|Reported Event|Ibandronate|Ibandronate adverse events
492448|NCT00376961|B1|Baseline|Rituximab-CHOP-Bortezomib (R-CHOP-V)|R-CHOP-V will be administered for 6 cycles (one cycle is defined as a single 21-day course of treatment).
492449|NCT00376961|P2|Participant Flow|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492450|NCT00376961|P1|Participant Flow|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
492451|NCT00376961|O2|Outcome|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492452|NCT00376961|O1|Outcome|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle = 21 days)
492453|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 dyas). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492454|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492455|NCT00376961|O1|Outcome|R-CHOP-V Followed by VM|Rituximab-CHOP-bortezomib induction therapy (RCHOP-V) followed by Bortezomib maintenance therapy (VM). R-CHOP-V is administered for 6 cycles (1 cycle = 21 days). Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492567|NCT00376506|B1|Baseline|Vibrotactile|An external vibrotactile device used for swallowing retraining
492456|NCT00376961|E2|Reported Event|Bortezomib Maintenance (VM)|Bortezomib maintenance (VM) therapy is given 3 months after the completion of R-CHOP-V induction therapy. Treatment with VM is administered once every 3 month for 8 cycles, Cycle 7-14 ( 1 cycle = 3 months)
492457|NCT00376961|E1|Reported Event|Rituximab-CHOP-Bortezomib (R-CHOP-V) Induction|Rituximab-CHOP-Bortezomib (R-CHOP-V) induction is administered every 21 days for 6 cycles (1 cycle= 21 days)
492458|NCT00376948|B1|Baseline|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
492459|NCT00376948|P1|Participant Flow|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
492460|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
492461|NCT00376948|O1|Outcome|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
492462|NCT00376948|E1|Reported Event|Novasoy®, Gemcitabine & Erlotinib|"Novasoy® 396 mg (177 mg of Isoflavones) twice-daily starting daay -7 until day 28; Gemcitabine 1000 mg/m2 days 1, 8, & 15; Erlotinib 150 mg day 1 until day 28~genistein~erlotinib hydrochloride~gemcitabine hydrochloride"
492463|NCT00376935|B5|Baseline|Total|Total of all reporting groups
492464|NCT00376935|B4|Baseline|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492465|NCT00376935|B3|Baseline|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492466|NCT00376935|B2|Baseline|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492467|NCT00376935|B1|Baseline|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492468|NCT00376935|P4|Participant Flow|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492469|NCT00376935|P3|Participant Flow|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492470|NCT00376935|P2|Participant Flow|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492471|NCT00376935|P1|Participant Flow|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492472|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492473|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492474|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492475|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492476|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492477|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492478|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492479|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492480|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492481|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492482|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492483|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492484|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492485|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
498298|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
492486|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492487|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492488|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492489|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492490|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492491|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492492|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492493|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492494|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492495|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492496|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492497|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492498|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492499|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492500|NCT00376935|O4|Outcome|Palifermin (60 mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492501|NCT00376935|O3|Outcome|Palifermin (40 mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492502|NCT00376935|O2|Outcome|Palifermin (20 mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492503|NCT00376935|O1|Outcome|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492504|NCT00376935|E4|Reported Event|Palifermin (60 Mcg/kg)|Participants will receive 1 palifermin 60 mcg/kg (0.012) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492505|NCT00376935|E3|Reported Event|Palifermin (40 Mcg/kg)|Participants will receive 1 palifermin 40 mcg/kg (0.008) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492506|NCT00376935|E2|Reported Event|Palifermin (20 Mcg/kg)|Participants will receive 1 palifermin 20 mcg/kg (0.004) mL/kg IV bolus injection, two placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492507|NCT00376935|E1|Reported Event|Palifermin Placebo|Participants will receive 3 placebo for palifermin IV bolus injections on each of 3 consecutive days: day 1 (entry), day 2 and day 3.
492508|NCT00376805|B1|Baseline|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492509|NCT00376805|P1|Participant Flow|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492510|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492511|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492512|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492513|NCT00376805|O1|Outcome|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492514|NCT00376805|E1|Reported Event|NK Cells With or Without Total Body Irradiation|Patients receiving natural killer cell infusion, fludarabine and cyclosphosphamide preparatory regimen, and with or without total body irradiation for treatment of metastatic breast cancer.
492515|NCT00376688|B1|Baseline|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
492516|NCT00376688|P1|Participant Flow|Temsirolimus|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
492517|NCT00376688|O1|Outcome|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
492518|NCT00376688|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Temsirolimus: Given IV"
492519|NCT00376675|B3|Baseline|Total|Total of all reporting groups
492520|NCT00376675|B2|Baseline|Placebo|Patients receive oral placebo daily on days 1-28.
492521|NCT00376675|B1|Baseline|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492522|NCT00376675|P2|Participant Flow|Placebo|Patients receive oral placebo daily on days 1-28.
492523|NCT00376675|P1|Participant Flow|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492524|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492525|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492526|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492527|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492528|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492529|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492530|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492531|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492532|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492533|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492534|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492535|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492536|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492537|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492538|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492539|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492540|NCT00376675|O2|Outcome|Placebo|Patients receive oral placebo daily on days 1-28.
492541|NCT00376675|O1|Outcome|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492542|NCT00376675|E2|Reported Event|Placebo|Patients receive oral placebo daily on days 1-28.
492543|NCT00376675|E1|Reported Event|Methylphenidate|Patients receive oral methylphenidate daily on days 1-28.
492544|NCT00376558|B3|Baseline|Total|Total of all reporting groups
492545|NCT00376558|B2|Baseline|Control Subjects|Healthy controls who undergo scans
492546|NCT00376558|B1|Baseline|Cocaine Users|Cocaine users receiving CRA
492547|NCT00376558|P2|Participant Flow|Control Subjects|Healthy controls who undergo scans
492548|NCT00376558|P1|Participant Flow|Cocaine Users|Cocaine users receiving CRA
492549|NCT00376558|O1|Outcome|Cocaine Abuser Undergoing CM With CRA Treatment|Participants receive voucher points for each urine sample that tested negative for benzoylecgonine. Failure to submit a scheduled sample was treated as cocaine +. Voucher points have a monetary value that can be redeemed for goods/services that are approved by the therapist. Points ($0.25) were acquired on an escalating schedule that started at 10 points for the 1st cocaine-free sample, and each subsequent cocaine-free sample increased the value by 5 points. A bonus of 40 points ($10.00) for every 3 consecutive negative sample. Abstinence was confirmed by onsite urine test (Abuscreen On-Trak system, Roche Diagnostics). Missed clinic visits and urine samples that are considered + reset the points to the initial $2.50 value and the escalation schedule resume. Submission of 5 consecutive - samples after a + urine returns the voucher points to the value prior to reset. Points earned are never lost. A maximum of $997.50 is earned for submitting negative samples at all treatment visits.
492550|NCT00376558|O2|Outcome|Control Subjects|Healthy controls who undergo scans
492551|NCT00376558|O1|Outcome|Cocaine Users|Cocaine users receiving CRA
492552|NCT00376558|E2|Reported Event|Control Subjects|Healthy controls who undergo scans
492553|NCT00376558|E1|Reported Event|Cocaine Users|Cocaine users receiving CRA
492554|NCT00376532|B3|Baseline|Total|Total of all reporting groups
492555|NCT00376532|B2|Baseline|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
492556|NCT00376532|B1|Baseline|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
492557|NCT00376532|P2|Participant Flow|No ICD Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
492558|NCT00376532|P1|Participant Flow|ICD Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
492559|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
492560|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
492561|NCT00376532|O2|Outcome|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
492562|NCT00376532|O1|Outcome|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
492563|NCT00376532|E2|Reported Event|No ICD Pacing or Shock Event|Subjects who did not experience a treatment defined as a pacing event or a shock event
492564|NCT00376532|E1|Reported Event|ICD Pacing or Shock Event|Subjects who experienced a device treatment, defined as a pacing event or a shock event
492565|NCT00376506|B3|Baseline|Total|Total of all reporting groups
492566|NCT00376506|B2|Baseline|Intramuscular|An implanted neurostimulator device used for swallowing retraining
498299|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
492568|NCT00376506|P2|Participant Flow|Intramuscular|An implanted neurostimulator device used for swallowing retraining
492569|NCT00376506|P1|Participant Flow|Vibrotactile|An external vibrotactile device used for swallowing retraining
492570|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492571|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492572|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492573|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492574|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492575|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492576|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing retraining. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492577|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492578|NCT00376506|O2|Outcome|Intramuscular|Patients utilized an implanted neurostimulator device for swallowing. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.retraining
492579|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492580|NCT00376506|O2|Outcome|Intramuscular|Patients used a surgically implanted intramuscular stimulation device. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492581|NCT00376506|O1|Outcome|Vibrotactile|Patients utilized an external vibrotactile device placed on the thyroid cartilage. Patients were trained to initiate a swallow within 500 ms of stimulation. Stimulation was induced by a patient operated handheld controller. Patients were instructed to perform 60 trials per day.
492582|NCT00376506|E2|Reported Event|Intramuscular|An implanted neurostimulator device used for swallowing retraining
492583|NCT00376506|E1|Reported Event|Vibrotactile|An external vibrotactile device used for swallowing retraining
492584|NCT00376363|B3|Baseline|Total|Total of all reporting groups
492585|NCT00376363|B2|Baseline|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492586|NCT00376363|B1|Baseline|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492587|NCT00376363|P2|Participant Flow|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492588|NCT00376363|P1|Participant Flow|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492589|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492590|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492591|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492592|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492593|NCT00376363|O2|Outcome|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492594|NCT00376363|O1|Outcome|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492595|NCT00376363|E2|Reported Event|Baerveldt Implant|"Baerveldt glaucoma drainage implant for intraocular pressure control~Baerveldt implant: placement of glaucoma drainage device to control intraocular press"
492596|NCT00376363|E1|Reported Event|Ahmed Implant,1|"Ahmed glaucoma drainage implant for intraocular pressure control~Ahmed implant: placement of glaucoma drainage device to control intraocular pressure"
492597|NCT00376259|B3|Baseline|Total|Total of all reporting groups
492598|NCT00376259|B2|Baseline|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
498300|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
492599|NCT00376259|B1|Baseline|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492600|NCT00376259|P2|Participant Flow|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492601|NCT00376259|P1|Participant Flow|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492602|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492603|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492604|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492605|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492606|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492607|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492608|NCT00376259|O2|Outcome|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492609|NCT00376259|O1|Outcome|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492610|NCT00376259|E2|Reported Event|Adefovir Monotherapy|Adefovir monotherapy: 10 mg of adefovir by mouth once daily for 96 weeks.
492611|NCT00376259|E1|Reported Event|Combination Therapy|Combination therapy: 600 mg of telbivudine (LdT) by mouth plus 10 mg of adefovir (ADV) by mouth once daily for 96 weeks.
492612|NCT00376168|B3|Baseline|Total|Total of all reporting groups
492613|NCT00376168|B2|Baseline|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492614|NCT00376168|B1|Baseline|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492615|NCT00376168|P2|Participant Flow|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492616|NCT00376168|P1|Participant Flow|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492617|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492618|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492619|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492620|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492621|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492622|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492623|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492624|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492625|NCT00376168|O2|Outcome|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492626|NCT00376168|O1|Outcome|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492627|NCT00376168|E2|Reported Event|ELELYSO 60 Units/kg|Taliglucerase alfa 60 Units/kg by intravenous infusion every two weeks
492628|NCT00376168|E1|Reported Event|ELELYSO 30 Units/kg|Taliglucerase alfa 30 Units/kg by intravenous infusion every two weeks
492629|NCT00375999|B1|Baseline|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
492630|NCT00375999|P1|Participant Flow|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
492631|NCT00375999|O1|Outcome|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
492632|NCT00375999|E1|Reported Event|Treatment Group|Salvage Chemotherapy with Docetaxel and Epirubicin for Advanced/Metastatic Gastric Cancer
492633|NCT00375973|B3|Baseline|Total|Total of all reporting groups
492634|NCT00375973|B2|Baseline|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492635|NCT00375973|B1|Baseline|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492636|NCT00375973|P2|Participant Flow|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492637|NCT00375973|P1|Participant Flow|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492638|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492639|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492640|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492641|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492642|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492643|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492644|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492645|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492646|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492647|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492648|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492649|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492650|NCT00375973|O2|Outcome|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492651|NCT00375973|O1|Outcome|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492652|NCT00375973|E2|Reported Event|Placebo|"Placebo comparator to Duloxetine~Placebo: Sugar pill dose comparable to duloxetine"
492653|NCT00375973|E1|Reported Event|Duloxetine|"Duloxetine po 60-120 mg/day for 12 weeks~Duloxetine: Duloxetine po 60-120 mg/day for 12 weeks"
492654|NCT00375934|B3|Baseline|Total|Total of all reporting groups
492655|NCT00375934|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
492656|NCT00375934|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492657|NCT00375934|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
492658|NCT00375934|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492659|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492660|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492661|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492662|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492663|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492664|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492665|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492666|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492667|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492668|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492669|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492670|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492671|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492672|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492673|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492674|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492675|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492676|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492677|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492678|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492679|NCT00375934|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
492680|NCT00375934|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492681|NCT00375934|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
492682|NCT00375934|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
492683|NCT00375752|B3|Baseline|Total|Total of all reporting groups
492684|NCT00375752|B2|Baseline|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492685|NCT00375752|B1|Baseline|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492686|NCT00375752|P2|Participant Flow|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492687|NCT00375752|P1|Participant Flow|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492688|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492689|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492690|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492691|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492692|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492693|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492694|NCT00375752|O2|Outcome|Letrozole +Zoledronic Acid (LET+ZOL)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492695|NCT00375752|O1|Outcome|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492696|NCT00375752|E2|Reported Event|Letrozole + Zoledronic Acid (Let + Zol)|2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvant treatment plus zoledronic acid 4 mg i.v. q4w
492697|NCT00375752|E1|Reported Event|Letrozole (LET)|Letrozole 2.5 mg/day oral letrozole for approximately 6.5 months neoadjuvent treatment.
492698|NCT00375713|B3|Baseline|Total|Total of all reporting groups
492699|NCT00375713|B2|Baseline|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492700|NCT00375713|B1|Baseline|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492701|NCT00375713|P2|Participant Flow|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492702|NCT00375713|P1|Participant Flow|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492703|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492704|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492705|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492706|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492707|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492708|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492709|NCT00375713|O2|Outcome|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492710|NCT00375713|O1|Outcome|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492711|NCT00375713|E2|Reported Event|Cetirizine|Cetirizine 10 mg tablet once daily plus Placebo - Levocetirizine 5 mg once daily plus standard topical steroid ointment
492712|NCT00375713|E1|Reported Event|Levocetirizine|Levocetirizine 5 mg tablet once daily plus Placebo - Cetirizine 10 mg tablet once daily plus standard topical steroid ointment
492713|NCT00375518|B3|Baseline|Total|Total of all reporting groups
492714|NCT00375518|B2|Baseline|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492715|NCT00375518|B1|Baseline|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492716|NCT00375518|P2|Participant Flow|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492717|NCT00375518|P1|Participant Flow|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492718|NCT00375518|O2|Outcome|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492719|NCT00375518|O1|Outcome|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492720|NCT00375518|E2|Reported Event|Placebo|Placebo: Placebo given beginning 7 days before the operation. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492721|NCT00375518|E1|Reported Event|Atorvastatin|Atorvastatin: Atorvastatin 40 mg once a day beginning 7 days before the operation. Surgical procedures will be as planned and unaffected by this study. Starting from the day after surgery, patients will be given their study drug for an additional 7 days.
492722|NCT00375505|B3|Baseline|Total|Total of all reporting groups
492723|NCT00375505|B2|Baseline|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492724|NCT00375505|B1|Baseline|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492725|NCT00375505|P2|Participant Flow|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492726|NCT00375505|P1|Participant Flow|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492727|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492728|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492729|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492730|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492731|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492732|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492733|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492734|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492735|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492736|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492737|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492738|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492739|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492740|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492741|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492742|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492743|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492744|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
498301|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
492745|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492746|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492747|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492748|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492749|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492750|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492751|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492752|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492753|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492754|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492755|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492756|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492757|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492758|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492759|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492760|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492761|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492762|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492763|NCT00375505|O2|Outcome|Zometa|Zoledronic Acid 4mg as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492764|NCT00375505|O1|Outcome|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492765|NCT00375505|E2|Reported Event|Zometa|Zometa
492766|NCT00375505|E1|Reported Event|Placebo|Placebo as a 15-minute infusion every 3 months for a treatment period of 24 months (total of 8 infusions).
492767|NCT00375492|B3|Baseline|Total|Total of all reporting groups
492768|NCT00375492|B2|Baseline|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492769|NCT00375492|B1|Baseline|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492770|NCT00375492|P2|Participant Flow|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492771|NCT00375492|P1|Participant Flow|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492772|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492773|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492774|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492775|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492776|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492777|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492778|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492779|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492780|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492781|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492782|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492783|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492784|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492785|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492786|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492787|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492788|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492789|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492790|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492791|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492792|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
498302|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
492793|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492794|NCT00375492|O2|Outcome|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492795|NCT00375492|O1|Outcome|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492796|NCT00375492|E2|Reported Event|Group B (Placebo)|placebo (volume equivalent to exenatide injection) twice daily for 24 weeks
492797|NCT00375492|E1|Reported Event|Group A (Exenatide)|exenatide 5mcg twice daily for 4 weeks, followed by exenatide 10mcg twice daily for 20 weeks
492798|NCT00375427|B3|Baseline|Total|Total of all reporting groups
492799|NCT00375427|B2|Baseline|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492800|NCT00375427|B1|Baseline|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492801|NCT00375427|P2|Participant Flow|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492802|NCT00375427|P1|Participant Flow|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492803|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492804|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492805|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492806|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492807|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492808|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492809|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492810|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492811|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492812|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492813|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492814|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492815|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492816|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
493071|NCT00374244|E2|Reported Event|Active Pimozide|Half of the subjects are randomized to the active drug.
493072|NCT00374244|E1|Reported Event|Placebo Pimozide|Half of the subjects were randomized to placebo group.
492817|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492818|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492819|NCT00375427|O2|Outcome|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions.
492820|NCT00375427|O1|Outcome|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492821|NCT00375427|E2|Reported Event|Zoledronic Acid Every 4 Weeks|Zoledronic acid given as a 15-minute (at least) i.v. infusion every 4 weeks. The dose of study drug was the as same administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Participants randomized to this group received up to 12 infusions
492822|NCT00375427|E1|Reported Event|Zoledronic Acid Every 3 Months|Zoledronic acid given as a 15-minute (at least) i.v. infusion every three months. The dose of study drug was the same as administered before study entry; that is, 4 mg or a reduced dose, i.e. 3.5 mg, or 3.3 mg or 3.0 mg. Randomized participants received a maximum of 4 infusions in this group.
492823|NCT00375219|B4|Baseline|Total|Total of all reporting groups
492824|NCT00375219|B3|Baseline|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492825|NCT00375219|B2|Baseline|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492826|NCT00375219|B1|Baseline|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492827|NCT00375219|P3|Participant Flow|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492828|NCT00375219|P2|Participant Flow|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492829|NCT00375219|P1|Participant Flow|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492830|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492831|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492832|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492889|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
498303|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
492833|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492834|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492835|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492836|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492837|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492838|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492839|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492840|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492841|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492842|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492843|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492844|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492845|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492846|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492847|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492848|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492849|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492850|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492851|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492852|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492853|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492854|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492855|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492856|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492857|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492858|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492859|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492860|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
493062|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493063|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
492861|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492862|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492863|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492864|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492865|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492866|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492867|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492868|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492869|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492870|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492871|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492872|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492873|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492874|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
493064|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493065|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
492875|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492876|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492877|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492878|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492879|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492880|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492881|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492882|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492883|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492884|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492885|NCT00375219|O4|Outcome|Total Participants|Treatment included induction therapy of subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492886|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492887|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492888|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
493066|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493067|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
492890|NCT00375219|O3|Outcome|CML: Blast Phase|Study participants with chronic myeloid leukemia (CML) in the blast phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492891|NCT00375219|O2|Outcome|CML: Accelerated Phase|Study participants with chronic myeloid leukemia (CML) in the accelerated phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492892|NCT00375219|O1|Outcome|CML: Chronic Phase|Study participants with chronic myeloid leukemia (CML) in the chronic phase at the time of enrollment. Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 3 years.
492893|NCT00375219|E1|Reported Event|Omacetaxine|Treatment was the same for all cohorts: induction therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 14 consecutive days every 28 (±3) days for up to 6 cycles. Maintenance therapy was subcutaneous (SC) administration of omacetaxine at 1.25 mg/m^2 twice a day (BID), administered for 7 consecutive days every 28 (±3) days for up to 24 months.
492894|NCT00374907|B3|Baseline|Total|Total of all reporting groups
492895|NCT00374907|B2|Baseline|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
492896|NCT00374907|B1|Baseline|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
492897|NCT00374907|P2|Participant Flow|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, up to 104 weeks starting at Week 12 (end of ST period). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
492898|NCT00374907|P1|Participant Flow|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term). Metformin 500-1500 mg (open-label, as needed for rescue in LT).
492899|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
492900|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
492901|NCT00374907|O2|Outcome|Placebo / Metformin|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks; Metformin Tablet, Oral, 500 mg/1000 mg, once daily, starting at Week 12 and up to 104 weeks
492902|NCT00374907|O1|Outcome|Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short-term) and up to 104 weeks (long-term)
492903|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
492904|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
492905|NCT00374907|O2|Outcome|Short Term Period: Placebo|Tablet, Oral, 0 mg, once daily, up to 12 weeks
492906|NCT00374907|O1|Outcome|Short Term Period: Saxagliptin 5 mg|Tablet, Oral, 5 mg, once daily, up to 12 weeks
492907|NCT00374907|E2|Reported Event|SAXAGLIPTIN 5 MG|Tablet, Oral, 5 mg, once daily, up to 12 weeks (short term); Tablet, Oral, 5 mg, once daily, up to 104 weeks (long term)
492908|NCT00374907|E1|Reported Event|PLACEBO/METFORMIN|Placebo Tablet, Oral, 0 mg, once daily, up to 12 weeks (short term); Metformin Tablet, Oral, 500 mg titrated to 1000 mg, once daily, up to 104 weeks (long term)
492909|NCT00374868|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492910|NCT00374868|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492911|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492912|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492913|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492914|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
493068|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493069|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
492915|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492916|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492917|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492918|NCT00374868|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492919|NCT00374868|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: phase 1 determined dose=400 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy Cisplatin: 50 mg/m2, intravenous (IV), days 1 and 15 every 28 days until disease progression, unacceptable toxicity or patient decision to discontinue or 6 cycles of therapy
492920|NCT00374842|B4|Baseline|Total|Total of all reporting groups
492921|NCT00374842|B3|Baseline|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492922|NCT00374842|B2|Baseline|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492923|NCT00374842|B1|Baseline|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492924|NCT00374842|P3|Participant Flow|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492925|NCT00374842|P2|Participant Flow|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492926|NCT00374842|P1|Participant Flow|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492927|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492928|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492929|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492930|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492931|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492932|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492933|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492934|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492935|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492936|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492937|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492938|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492939|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492940|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492941|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492942|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492943|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492944|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492945|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492946|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492947|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492948|NCT00374842|O3|Outcome|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492949|NCT00374842|O2|Outcome|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492950|NCT00374842|O1|Outcome|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492951|NCT00374842|E3|Reported Event|Fluarix Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm
492952|NCT00374842|E2|Reported Event|GSK1247446A Formulation 2 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492953|NCT00374842|E1|Reported Event|GSK1247446A Formulation 1 Group|Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
492954|NCT00374803|B3|Baseline|Total|Total of all reporting groups
492955|NCT00374803|B2|Baseline|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
492956|NCT00374803|B1|Baseline|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492957|NCT00374803|P2|Participant Flow|Myfortic 720 mg Twice Daily|Myfortic 720 mg twice daily (1440 mg/day).
492958|NCT00374803|P1|Participant Flow|Myfortic 1080mg BID, 720mg BID|Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492959|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
492960|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492961|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
492962|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492963|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
492964|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
498304|NCT00359801|E2|Reported Event|Non-Exubera®|Usual diabetes care
492965|NCT00374803|O2|Outcome|Mycophenolic Acid (Myfortic) Standard|"Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day).~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
492966|NCT00374803|O1|Outcome|Mycophenolic Acid (Myfortic) Preload|"Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~Mycophenolic Acid (Myfortic): • Group 1: Mycophenolic Acid (Myfortic) 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter~• Group 2: Mycophenolic Acid (Myfortic) 720 mg twice daily (1440 mg/day)."
492967|NCT00374803|O2|Outcome|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
492968|NCT00374803|O1|Outcome|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492969|NCT00374803|E2|Reported Event|Mycophenolic Acid No Load Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 720 mg twice daily (1440 mg/day)
492970|NCT00374803|E1|Reported Event|Mycophenolic Acid Loading Group|Thymoglobulin 1.5 mg/kg/dose x 4 doses on days 0, 2, 4 and 6, Tacrolimus 0.1 mg/kg/day divided twice daily, 7 days corticosteroid taper, and Myfortic 1080 mg twice daily (2160 mg/day) for two weeks, followed by 720 mg twice daily (1440 mg/day) thereafter
492971|NCT00374543|B3|Baseline|Total|Total of all reporting groups
492972|NCT00374543|B2|Baseline|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492973|NCT00374543|B1|Baseline|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492974|NCT00374543|P2|Participant Flow|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492975|NCT00374543|P1|Participant Flow|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492976|NCT00374543|O2|Outcome|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492977|NCT00374543|O1|Outcome|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492978|NCT00374543|E2|Reported Event|Placebo|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Identical placebo capsules will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492979|NCT00374543|E1|Reported Event|Ziprasidone, 40 to 160 mg/Day|Patients with Bipolar Disorder and Anxiety Comorbidity who consent and meet entry criteria will be randomized to placebo or Ziprasidone. Ziprasidone will be dosed on a BID basis, with flexible dosing based on tolerability, with a total daily dose in the range of 40 to 160 mg/day.
492980|NCT00374335|B1|Baseline|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
492981|NCT00374335|P1|Participant Flow|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
492982|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
492983|NCT00374335|O1|Outcome|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
492984|NCT00374335|E1|Reported Event|Group 1|Cutaneous Hemangiomas (multiple > 5, 1-4, or at least 1 hemangioms >30 cm2)
492985|NCT00374322|B3|Baseline|Total|Total of all reporting groups
492986|NCT00374322|B2|Baseline|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492987|NCT00374322|B1|Baseline|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492988|NCT00374322|P2|Participant Flow|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492989|NCT00374322|P1|Participant Flow|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492990|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492991|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492992|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492993|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492994|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492995|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492996|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492997|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492998|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
492999|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493000|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493001|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493002|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493003|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493004|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal
493005|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493006|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493007|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493008|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493009|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493010|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493011|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493012|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493013|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493014|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493070|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493015|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493016|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493017|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493018|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493019|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493020|NCT00374322|O2|Outcome|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493021|NCT00374322|O1|Outcome|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493022|NCT00374322|E2|Reported Event|Placebo|Participants received matching placebo orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493023|NCT00374322|E1|Reported Event|Lapatinib 1500 mg|Participants received lapatinib 1500 milligrams (mg) orally once daily. Treatment was continued for a maximum of 12 months or until disease recurrence or development of a second primary cancer, withdrawal from study treatment due to unacceptable toxicity, or consent withdrawal.
493024|NCT00374244|B3|Baseline|Total|Total of all reporting groups
493025|NCT00374244|B2|Baseline|Active Pimozide|Half of the subjects are randomized to the active drug.
493026|NCT00374244|B1|Baseline|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493027|NCT00374244|P2|Participant Flow|Active Pimozide|Half of the subjects are randomized to the active drug.
493028|NCT00374244|P1|Participant Flow|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493029|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493030|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493031|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493032|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493033|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493034|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493035|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493036|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493037|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493038|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493039|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493040|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493041|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493042|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493043|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493044|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493045|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493046|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493047|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493048|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493049|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493050|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493051|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493052|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493053|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493054|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493055|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493056|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493057|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493058|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493059|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493060|NCT00374244|O1|Outcome|Placebo Pimozide|Half of the subjects were randomized to placebo group.
493061|NCT00374244|O2|Outcome|Active Pimozide|Half of the subjects are randomized to the active drug.
493073|NCT00374231|B1|Baseline|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
493074|NCT00374231|P1|Participant Flow|Corticosteroid Withdrawal|Discontinue prednisone at 90 days or longer post liver transplant if rejection free previous 30 days.
493075|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
493076|NCT00374231|O1|Outcome|Corticosteroid Withdrawal|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
493077|NCT00374231|O1|Outcome|Corticosteroid Withdrawa.|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus: Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil: Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
493078|NCT00374231|E1|Reported Event|Tacrolimus and Mycophenolate Mofetil|"All the patients who enroll in this study will receive the same medications (tacrolimus, mycophenolate mofetil, and a short coarse of steroids) to prevent rejection of the liver transplant. All participants will be gradually taken off prednisone if they are 90 days or longer post liver transplant and have not had a rejection in the last 30 days.~tacrolimus : Tacrolimus is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis.~mycophenolate mofetil : Mycophenolate mofetil is a pill taken orally. Dose, frequency and duration will be decided by the study doctor on a case-by-case basis."
493079|NCT00374140|B1|Baseline|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
493080|NCT00374140|P1|Participant Flow|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
493081|NCT00374140|O1|Outcome|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
493082|NCT00374140|E1|Reported Event|RAD001 (Everolimus)|RAD001 (everolimus): 10 mg by mouth daily without interruption for 3-week cycles until disease progression or intolerable toxicities
493083|NCT00374088|B3|Baseline|Total|Total of all reporting groups
493084|NCT00374088|B2|Baseline|N-acetylcysteine|Patients treated with N-acetylcysteine
493085|NCT00374088|B1|Baseline|Placebo|Patients not treated with N-acetylcysteine
493086|NCT00374088|P2|Participant Flow|N-acetylcysteine|Patients treated with N-acetylcysteine
493087|NCT00374088|P1|Participant Flow|Placebo|Patients not treated with N-acetylcysteine
493088|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
493089|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
493090|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
493091|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
493092|NCT00374088|O2|Outcome|N-acetylcysteine|Patients treated with N-acetylcysteine
493093|NCT00374088|O1|Outcome|Placebo|Patients not treated with N-acetylcysteine
493094|NCT00374088|E2|Reported Event|N-acetylcysteine|Patients treated with N-acetylcysteine
493095|NCT00374088|E1|Reported Event|Placebo|Patients not treated with N-acetylcysteine
493096|NCT00373958|B3|Baseline|Total|Total of all reporting groups
493097|NCT00373958|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493098|NCT00373958|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493120|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
493099|NCT00373958|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493100|NCT00373958|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493101|NCT00373958|O4|Outcome|7vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493102|NCT00373958|O3|Outcome|13vPnC After the Toddler Dose|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493103|NCT00373958|O2|Outcome|7vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 7vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493104|NCT00373958|O1|Outcome|13vPnC After the Infant Series|Subjects received 1 single 0.5 mL dose of 13vPnC coadministered with Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493105|NCT00373958|O4|Outcome|7vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493106|NCT00373958|O3|Outcome|13vPnC After Toddler Dose|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493107|NCT00373958|O2|Outcome|7vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493108|NCT00373958|O1|Outcome|13vPnC After Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493109|NCT00373958|O8|Outcome|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493110|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493111|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
493112|NCT00373958|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
493113|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
493114|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
493115|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493116|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493117|NCT00373958|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493118|NCT00373958|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493119|NCT00373958|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 6 months (infant series).
493121|NCT00373958|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
493122|NCT00373958|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 4 months (infant series).
493123|NCT00373958|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493124|NCT00373958|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493125|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493126|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493127|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493128|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493129|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493130|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493131|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493132|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493133|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493268|NCT00373425|B6|Baseline|Total|Total of all reporting groups
493134|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493135|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493136|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493137|NCT00373958|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493138|NCT00373958|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493139|NCT00373958|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493140|NCT00373958|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493141|NCT00373958|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493142|NCT00373958|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with measles, mumps, rubella varicella vaccine live (ProQuad), Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate) (PedvaxHIB), and Hepatitis A Vaccine, Inactivated (VAQTA) at 12-15 months of age (toddler dose).
493143|NCT00373958|E4|Reported Event|7vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493144|NCT00373958|E3|Reported Event|13vPnC Post Infant Series|Participants received 1 single 0.5 mL dose together with a concomitant dose of Pediarix and ActHIB at the 2-, 4-, and 6-month visits and ProQuad, PedvaxHIB, and VAQTA at the 12-15 month visit.
493145|NCT00373958|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493146|NCT00373958|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2 months (infant series).
493147|NCT00373698|B3|Baseline|Total|Total of all reporting groups
493148|NCT00373698|B2|Baseline|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493149|NCT00373698|B1|Baseline|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493150|NCT00373698|P2|Participant Flow|Usual Care|"Participants randomized to Usual Care received care at the VA provider's discretion and could include referral to mental health specialty care."
493151|NCT00373698|P1|Participant Flow|Three Component Model of Collaborative Care and Usual Care|"Participants randomized to this arm received the Three Component Model of Collaborative Care (3CM) as well as usual care. 3CM model consists of 1) education and tools for primary care clinicians and staff including content regarding PTSD; 2) telephone care management by a centrally located care manager (the purpose of the calls was to identify barriers to adherance with the primary care provider's plan, aid participant to overcome them, and measure treatment response. Calls occurred 1, 4, and 8 weeks after the initial visit and then every 4 weeks for 6 months or until a participant acheived 30% reduction in PTSD symptoms as measure by the PCL); 3) support from a psychiatrist who supervises care managers by telephone, provides consultation to primary care clinicians, and facilitates mental health referral. Participant's Usual Care is at the VA provider's discretion and could include referral to mental health specialty care.specialty care."
493152|NCT00373698|O2|Outcome|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493153|NCT00373698|O1|Outcome|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493154|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493155|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493156|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493157|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493158|NCT00373698|O2|Outcome|Arm 2/Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493159|NCT00373698|O1|Outcome|Arm1/Three Component Model of Care Collaborative Care|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493160|NCT00373698|E2|Reported Event|Usual Care|"Patients randomized to Usual Care will receive care as usual by VA clinicians."
493161|NCT00373698|E1|Reported Event|Three Component Model|Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
493162|NCT00373685|B3|Baseline|Total|Total of all reporting groups
493163|NCT00373685|B2|Baseline|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493164|NCT00373685|B1|Baseline|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493165|NCT00373685|P2|Participant Flow|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493166|NCT00373685|P1|Participant Flow|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493167|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493168|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493169|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493170|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493171|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493172|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493173|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493174|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493175|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493176|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493177|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493178|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493179|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493180|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493181|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493182|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493183|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493184|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493185|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493186|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493187|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493188|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493189|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493190|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493191|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493192|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493193|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493194|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493195|NCT00373685|O2|Outcome|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493196|NCT00373685|O1|Outcome|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493197|NCT00373685|E2|Reported Event|nsNSAIDs|Prescription non-selective nonsteroidal anti-inflammatory drug (nsNSAID) treatment (except for aspirin), per US PI recommended dosing
493198|NCT00373685|E1|Reported Event|Celecoxib|Celecoxib open-label per United States Package Insert (US PI) recommended dosing
493199|NCT00372567|B4|Baseline|Total|Total of all reporting groups
493200|NCT00372567|B3|Baseline|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
493201|NCT00372567|B2|Baseline|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493202|NCT00372567|B1|Baseline|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493203|NCT00372567|P3|Participant Flow|Sunitinib (Phase 1)|Single 37.5 mg dose administered 24 hours after the last dose of imatinib
493204|NCT00372567|P2|Participant Flow|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493205|NCT00372567|P1|Participant Flow|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493206|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493207|NCT00372567|O1|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493208|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493209|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493210|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493211|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493212|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493213|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493214|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493215|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493216|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493217|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493218|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493219|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493220|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493221|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493222|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493223|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493224|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493225|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493226|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493227|NCT00372567|O1|Outcome|Sunitinib (Phase 3)|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493228|NCT00372567|O2|Outcome|Imatinib|Starting dose of 800 mg QD on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 600 mg QD.
493229|NCT00372567|O1|Outcome|Sunitinib|Starting dose of 37.5 mg once daily (QD) on Days 1, 7, and 14 for each cycle. Dose adjustments, if needed, included a reduction to 25 mg QD or an escalation to 50 mg QD.
493230|NCT00372567|E2|Reported Event|Imatinib|All participants who received Imatinib
493231|NCT00372567|E1|Reported Event|All Participants Who Received Sunitinib|Participants in Phase 1 sub- study and Phase 3 study
493232|NCT00372528|B1|Baseline|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
493233|NCT00372528|P1|Participant Flow|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
493350|NCT00373269|B2|Baseline|Hyperglycemic|Subjects with acute ischemic stroke and hyperglycemia.
493234|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
493235|NCT00372528|O1|Outcome|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
493236|NCT00372528|E1|Reported Event|Pregabalin|Pregabalin 150 to 600 milligram (mg) capsule orally twice daily, as per investigator’s discretion. Treatment was administered continuously as long as therapeutic response and tolerability was maintained, up to 5 years.
493237|NCT00373529|B1|Baseline|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493238|NCT00373529|P1|Participant Flow|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493239|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493240|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493241|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493242|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493243|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493244|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493245|NCT00373529|O1|Outcome|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493246|NCT00373529|E1|Reported Event|Clofarabine|Participants received an induction cycle of clofarabine 30 mg/m^2/day intravenous infusion for 5 consecutive days. Participants could then receive up to 5 additional cycles, repeated minimally every 28 days, of clofarabine 20 mg/m^2/day intravenous infusion for 5 consecutive days.
493247|NCT00373490|B3|Baseline|Total|Total of all reporting groups
493248|NCT00373490|B2|Baseline|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493249|NCT00373490|B1|Baseline|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493250|NCT00373490|P2|Participant Flow|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493251|NCT00373490|P1|Participant Flow|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493252|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493253|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493254|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493255|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493256|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493257|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493258|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493259|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493260|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493261|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493262|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493263|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493264|NCT00373490|O2|Outcome|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493265|NCT00373490|O1|Outcome|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493266|NCT00373490|E2|Reported Event|Vorinostat 400 mg|400 mg once daily (400 mg q.d.) continuous daily dosing for 21 days
493267|NCT00373490|E1|Reported Event|Vorinostat 600 mg|600 mg daily (300 mg twice daily [b.i.d.]) for 3 consecutive days followed by 4 days of rest (repeated 3 times over 21 days)
493269|NCT00373425|B5|Baseline|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
493270|NCT00373425|B4|Baseline|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
493271|NCT00373425|B3|Baseline|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
493272|NCT00373425|B2|Baseline|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493273|NCT00373425|B1|Baseline|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493274|NCT00373425|P5|Participant Flow|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
493275|NCT00373425|P4|Participant Flow|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
493276|NCT00373425|P3|Participant Flow|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
493277|NCT00373425|P2|Participant Flow|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493278|NCT00373425|P1|Participant Flow|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493279|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493280|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493281|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493282|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493283|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493284|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493285|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493286|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493287|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493288|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493289|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493290|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493291|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493292|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493293|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493294|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493295|NCT00373425|O2|Outcome|Placebo|Participants received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493351|NCT00373269|B1|Baseline|Normoglycemic|Subjects with acute ischemic stroke and normal blood glucose.
493296|NCT00373425|O1|Outcome|Erlotinib|Participants received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493297|NCT00373425|E5|Reported Event|BPC-OLC: Erlotinib|The BPC open-label cohort (BPC-OLC) includes participants randomized prior to 07 November 2007 who received at least 1 dose of study drug after being randomized, who entered the open-label erlotinib period. Data presented for the BPC-OLC included data from both the blinded period and the open-label erlotinib period.
493298|NCT00373425|E4|Reported Event|BPC-NOLC: Placebo Only|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and did not receive any erlotinib.
493299|NCT00373425|E3|Reported Event|BPC-NOLC: Erlotinib/Placebo|The BPC no open-label cohort (BPC-NOLC) includes participants randomized prior to 07 November 2007 who did not participate in the open-label erlotinib period and who were previously randomized to receive either erlotinib or placebo in the blinded period, and received at least one dose of erlotinib.
493300|NCT00373425|E2|Reported Event|RC: Placebo|Participants in the randomized cohort (RC) who received matching placebo tablets orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493301|NCT00373425|E1|Reported Event|RC: Erlotinib|Participants in the randomized cohort (RC) who received 150 mg/day erlotinib orally for 2 years or until relapse, death, participant request or investigator decision to discontinue study drug, or intolerable toxicity.
493302|NCT00373360|B1|Baseline|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493303|NCT00373360|P1|Participant Flow|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493304|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493305|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493306|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493307|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493308|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493309|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493310|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493311|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493312|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493313|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493314|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493315|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493316|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493317|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493318|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493319|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493320|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493321|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493322|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493323|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493324|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493325|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493326|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493327|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493328|NCT00373360|O1|Outcome|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493329|NCT00373360|E1|Reported Event|Treprostinil Sodium|All subjects received active treatment with treprostinil sodium.
493330|NCT00373334|B4|Baseline|Total|Total of all reporting groups
493331|NCT00373334|B3|Baseline|Conservative Measures Only|
493332|NCT00373334|B2|Baseline|Nizatidine 5.0 mg/kg b.i.d.|
493333|NCT00373334|B1|Baseline|Nizatidine 2.5 mg/kg b.i.d.|
493334|NCT00373334|P3|Participant Flow|Placebo|"Placebo plus Conservative Measures~Conservative Measures included:~Hypoallergenic formula thickened with dry rice cereal Avoidance of seated and supine positioning Elimination of tobacco smoke exposure"
493335|NCT00373334|P2|Participant Flow|Nizatidine 5.0 mg/kg Twice Daily|high dose nizatidine plus Conservative Measures
493336|NCT00373334|P1|Participant Flow|Nizatidine 2.5 mg/kg Twice Daily|low dose nizatidine plus Conservative Measures
493337|NCT00373334|O3|Outcome|Conservative Measures Only|
493338|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
493339|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
493340|NCT00373334|O3|Outcome|Conservative Measures Only|
493341|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
493342|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
493343|NCT00373334|O3|Outcome|Conservative Measures Only|
493344|NCT00373334|O2|Outcome|Nizatidine 5.0 mg/kg b.i.d.|
493345|NCT00373334|O1|Outcome|Nizatidine 2.5 mg/kg b.i.d.|
493346|NCT00373334|E3|Reported Event|Conservative Measures Only|
493347|NCT00373334|E2|Reported Event|Nizatidine 5.0 mg/kg b.i.d.|
493348|NCT00373334|E1|Reported Event|Nizatidine 2.5 mg/kg b.i.d.|
493349|NCT00373269|B3|Baseline|Total|Total of all reporting groups
493352|NCT00373269|P2|Participant Flow|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
493353|NCT00373269|P1|Participant Flow|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
493354|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
493355|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
493356|NCT00373269|O2|Outcome|Hyperglycemic Subjects|Subjects with acute ischemic stroke and hyperglycemia.
493357|NCT00373269|O1|Outcome|Normoglycemic Control|Subjects with acute ischemic stroke and normal blood glucose.
493358|NCT00373269|E2|Reported Event|Normoglycemic Control|Subjects with acute stroke and normal blood glucose.
493359|NCT00373269|E1|Reported Event|Diabetic Subject|Subjects with acute stroke, hyperglycemia and history of diabetes.
493360|NCT00373256|B3|Baseline|Total|Total of all reporting groups
493361|NCT00373256|B2|Baseline|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493362|NCT00373256|B1|Baseline|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493363|NCT00373256|P2|Participant Flow|Bevacizumab + Paclitaxel|Bevacizumab 10 milligrams per kilogram (mg/kg); infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493364|NCT00373256|P1|Participant Flow|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 milligrams (mg) daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 milligrams per square meter (mg/m^2), at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493365|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493366|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493367|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493368|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493369|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493370|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493371|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493372|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493373|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493374|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493375|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493376|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493410|NCT00372996|B3|Baseline|Total|Total of all reporting groups
494307|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
493377|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493378|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493379|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493380|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493381|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493382|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493383|NCT00373256|O2|Outcome|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493384|NCT00373256|O1|Outcome|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493385|NCT00373256|E2|Reported Event|Bevacizumab + Paclitaxel|Bevacizumab 10 mg/kg; infusion duration according to standard of care. Paclitaxel starting dose of 90 mg/m^2, as a 1 hour infusion. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493386|NCT00373256|E1|Reported Event|Sunitinib + Paclitaxel|Starting sunitinib doses of 25 mg daily. After Cycle 1, escalation to 37.5 mg daily was permitted in the absence of complicated neutropenia and if all 3 Cycle 1 paclitaxel doses were successfully administered at 90 mg/m^2, at discretion of the investigator. Paclitaxel could have been reduced to 65 mg/m^2 based on tolerability; re-escalation to 80 or 90 mg/m^2 upon recovery was permitted.
493387|NCT00373113|B3|Baseline|Total|Total of all reporting groups
493388|NCT00373113|B2|Baseline|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493389|NCT00373113|B1|Baseline|Sunitinib|37.5 mg daily, continuous dosing
493390|NCT00373113|P2|Participant Flow|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493391|NCT00373113|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) daily, continuous dosing
493392|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493393|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493394|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493395|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493396|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493397|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493398|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493399|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493400|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493401|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493402|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493403|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493404|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493405|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493406|NCT00373113|O2|Outcome|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493407|NCT00373113|O1|Outcome|Sunitinib|37.5 mg daily, continuous dosing
493408|NCT00373113|E2|Reported Event|Capecitabine|1250 milligrams per square meter (mg/m^2) or 1000 mg/m^2 in older participants, twice daily for 2 consecutive weeks, followed by a 1-week rest period and given as 3-week cycles
493409|NCT00373113|E1|Reported Event|Sunitinib|37.5 mg daily, continuous dosing
493411|NCT00372996|B2|Baseline|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
493412|NCT00372996|B1|Baseline|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression could have received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
493413|NCT00372996|P4|Participant Flow|Exemestane/CP-751,871 + Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed.
493414|NCT00372996|P3|Participant Flow|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493415|NCT00372996|P2|Participant Flow|CP-751,871 + Exemestane/CP-751,871 + Fulvestrant|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability.
493416|NCT00372996|P1|Participant Flow|CP-751,871 Plus (+) Exemestane|Participants received CP-751,871 20 milligrams per kilogram (mg/kg) on Day 1 of each 3-week cycle as an intravenous (IV) infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493417|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493418|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493419|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493420|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493421|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493422|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493423|NCT00372996|O2|Outcome|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493424|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493425|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493426|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493427|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493428|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493429|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493430|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493431|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493432|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493433|NCT00372996|O2|Outcome|Exemestane|Participants were assigned to receive exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493434|NCT00372996|O1|Outcome|CP-751,871 + Exemestane|Participants were assigned to receive CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493435|NCT00372996|E4|Reported Event|CP-751,871 + Exemestane (After Exemestane)|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 3-week cycle in combination with exemestane 25 mg tablets, by mouth, once daily, for up to a total of 20 months or beyond if safety and clinical benefit were observed. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
493436|NCT00372996|E3|Reported Event|Exemestane|Participants received exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493571|NCT00372411|E3|Reported Event|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
500043|NCT00355615|E2|Reported Event|Rosuva 10|rosuvastatin 10 mg
493437|NCT00372996|E2|Reported Event|CP-751,871 + Fulvestrant (After CP-751,871+Exemestane)|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression. Participants who experienced disease progression received salvage therapy with CP-751,871 20 mg/kg on Day 1 of each 4-week cycle in combination with fulvestrant, administered according to the local label and standard clinical practice. Participants continued salvage treatment if safety and clinical benefit were observed for up to a total of 26 cycles or beyond, if there was continued clinical benefit, safety, and tolerability. Adverse events are presented from the period of time when the participant was receiving salvage therapy treatment only.
493438|NCT00372996|E1|Reported Event|CP-751,871 + Exemestane|Participants received CP-751,871 20 mg/kg on Day 1 of each 3-week cycle as an IV infusion in combination with exemestane 25 mg tablets, by mouth, once daily, until disease progression.
493439|NCT00372970|B3|Baseline|Total|Total of all reporting groups
493440|NCT00372970|B2|Baseline|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
493441|NCT00372970|B1|Baseline|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
493442|NCT00372970|P2|Participant Flow|Placebo|Received 5 cc saline injected into pyloric sphincter endoscopically.
493443|NCT00372970|P1|Participant Flow|Botulinum Toxin|Received 200U of Botox injected into pyloric sphincter endoscopically.
493444|NCT00372970|O2|Outcome|Placebo|saline Injection into pylorus
493445|NCT00372970|O1|Outcome|Botox|Botox injection into pylorus
493446|NCT00372970|E2|Reported Event|Placebo|saline Injection into pylorus
493447|NCT00372970|E1|Reported Event|Botox|Botox injection into pylorus
493448|NCT00372775|B1|Baseline|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493449|NCT00372775|P1|Participant Flow|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493450|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493451|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493452|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493453|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493454|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493455|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493456|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493457|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493458|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493459|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493460|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493461|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493462|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493463|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493464|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493465|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493466|NCT00372775|O1|Outcome|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493467|NCT00372775|E1|Reported Event|Sunitinib|Sunitinib 37.5 mg oral capsule daily
493468|NCT00372697|B3|Baseline|Total|Total of all reporting groups
493469|NCT00372697|B2|Baseline|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493470|NCT00372697|B1|Baseline|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493471|NCT00372697|P2|Participant Flow|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493472|NCT00372697|P1|Participant Flow|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493473|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493650|NCT00371839|O1|Outcome|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493474|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493475|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493476|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493477|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493478|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493479|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493480|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493481|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493482|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493483|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493484|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493485|NCT00372697|O2|Outcome|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
500044|NCT00355615|E1|Reported Event|Rosuva 5|rosuvastatin 5 mg
493486|NCT00372697|O1|Outcome|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493487|NCT00372697|E2|Reported Event|Octreotide 60 mg Every 28 Days|Participants received octreotide 60 mg every 28 days intramuscularly (im) for 6 months, a total of 6 doses. Octreotide mg was administered as two 30 mg injections. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493488|NCT00372697|E1|Reported Event|Octreotide 30 mg Every 21 Days|Participants received octreotide 30 mg every 21 days intramuscularly (im) for 6 months, a total of 8 doses. At each study visit, octreotide was administered only after completion of all scheduled efficacy and safety evaluations for that visit. Octreotide was injected im into the right or left gluteal regions. The injections were initially administered by a trained and authorized member of the investigational team. When no study visit at the investigational site was required, the injections were given by a trained nurse or the family doctor.
493489|NCT00372619|B8|Baseline|Total|Total of all reporting groups
493490|NCT00372619|B7|Baseline|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493491|NCT00372619|B6|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493492|NCT00372619|B5|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493493|NCT00372619|B4|Baseline|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493494|NCT00372619|B3|Baseline|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493495|NCT00372619|B2|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493496|NCT00372619|B1|Baseline|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493497|NCT00372619|P7|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493498|NCT00372619|P6|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493499|NCT00372619|P5|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493500|NCT00372619|P4|Participant Flow|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493501|NCT00372619|P3|Participant Flow|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493502|NCT00372619|P2|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493503|NCT00372619|P1|Participant Flow|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
494308|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
493504|NCT00372619|O7|Outcome|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493505|NCT00372619|O6|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493506|NCT00372619|O5|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493507|NCT00372619|O4|Outcome|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493508|NCT00372619|O3|Outcome|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493509|NCT00372619|O2|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493510|NCT00372619|O1|Outcome|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493511|NCT00372619|E7|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy - Ambiguous Lineage pt|"Clofarabine 52 mg/m² to assess efficacy in acute leukemia of ambiguous lineage patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493651|NCT00371839|E1|Reported Event|Arm 1|"Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493512|NCT00372619|E6|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in AML Patients|"Clofarabine 52 mg/m² to assess efficacy in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493513|NCT00372619|E5|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 52 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493514|NCT00372619|E4|Reported Event|Clofarabine 52 mg/m² to Assess Efficacy in ALL Patients.|"Clofarabine 52 mg/m² to assess efficacy in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493515|NCT00372619|E3|Reported Event|Clofarabine 52 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 52 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 52 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 52 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493516|NCT00372619|E2|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in AML Patients.|"Clofarabine 40 mg/m² to assess feasibility in AML patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493517|NCT00372619|E1|Reported Event|Clofarabine 40 mg/m² to Assess Feasibility in ALL Patients.|"Clofarabine 40 mg/m² to assess feasibility in ALL patients. Patients receive Cycle 1 (14-42 days) Cytarabine IT (aged based dosage 1-1.99 30 mg, 2-2.99 50 mg, ≥ 3 years 70 mg on Day 0, Clofarabine IV (dosage 40 mg/m2/dose) on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Cycle 2 (14-42 days) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5. Maintenance cycles 1-10 (14-42 days each) Methotrexate IT (age based dosage 1-1.99 8 mg, 2-2.99 10 mg, ≥ 3 12 mg) on day 1, Clofarabine IV 40 mg/m2/dose on days 1-5, and High Dose Cytarabine IV 1000 mg/m2/dose on days 1-5.~clofarabine: Given IV for 5 days~cytarabine: Given IV~methotrexate: Given intrathecally or IT age based dosage~laboratory biomarker analysis"
493518|NCT00372593|B4|Baseline|Total|Total of all reporting groups
493519|NCT00372593|B3|Baseline|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493527|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493520|NCT00372593|B2|Baseline|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493521|NCT00372593|B1|Baseline|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493522|NCT00372593|P3|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493523|NCT00372593|P2|Participant Flow|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of gemtuzumab ozogamicin (GMTZ) (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493524|NCT00372593|P1|Participant Flow|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493525|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493526|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493537|NCT00372489|E1|Reported Event|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
493652|NCT00371826|B4|Baseline|Total|Total of all reporting groups
493528|NCT00372593|O3|Outcome|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493529|NCT00372593|O2|Outcome|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493530|NCT00372593|O1|Outcome|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493531|NCT00372593|E3|Reported Event|Arm A: Standard Arm - No GMTZ, AML Patients With Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493532|NCT00372593|E2|Reported Event|Arm B: Experimental - With GMTZ, AML Pts w/Out Down Syndrome|Pts receive IT ARA-C at diagnosis or on day 1 of treatment or twice a week for up to six doses. They also receive an infusion of ARA-C on days 1-10; a 6-hr infusion of daunorubicin on days 1, 3, & 5; a 4-hr infusion of etoposide on days 1-5; and a 2-hr infusion of GMTZ - gemtuzumab ozogamicin (Mylotarg) on day 6. After 3 wks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 wks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hr infusion of mitoxantrone hydrochloride on days 3-6. They also receive a 2-hr infusion of gemtuzumab on day 7. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493533|NCT00372593|E1|Reported Event|Arm A: Standard Arm - No GMTZ, AML Pts w/Out Down Syndrome|Patients receive intrathecal (IT) cytarabine (ARA-C) at diagnosis or on day 1 of treatment or twice a week for up to 6 doses. They also receive an infusion of ARA-C on days 1-10; a 6-hour infusion of daunorubicin hydrochloride on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, patients receive IT ARA-C on day 1. They also receive an infusion of ARA-C on days 1-8; a 6-hr infusion of daunorubicin on days 1, 3, and 5; and a 4-hr infusion of etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1 and 1-hr infusions of ARA-C and etoposide on days 1-5. After 3 weeks of rest, some patients receive IT ARA-C on day 1; a 2-hr infusion of ARA-C on days 1-4; and a 1-hour infusion of mitoxantrone on days 3-6. After 3 weeks of rest, they receive a 3-hr infusion of ARA-C on days 1, 2, 8, and 9 and an injection of asparaginase on days 2 and 9.
493534|NCT00372489|B1|Baseline|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
493535|NCT00372489|P1|Participant Flow|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
493536|NCT00372489|O1|Outcome|Peginesatide|Participants received the same initial peginesatide dose as was administered at the end of the previous peginesatide treatment study (NCT00228449) in which the participant was enrolled. The median first dose at study start was 0.087 milligram per kilogram (mg/kg) with an interquartile range of 0.064 to 0.123 mg/kg. Each participant was to receive peginesatide as an injection administered intravenously once every 4 weeks for approximately 54 months in this trial.
493782|NCT00371787|P2|Participant Flow|Control Group|normal non-lens wearers
493538|NCT00372424|B1|Baseline|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493539|NCT00372424|P1|Participant Flow|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493540|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493541|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493542|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493543|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493544|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493545|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493546|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493547|NCT00372424|O1|Outcome|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
501156|NCT00351533|B3|Baseline|Total|Total of all reporting groups
493548|NCT00372424|E1|Reported Event|Sunitinib + Docetaxel + Trastuzumab|Sunitinib 37.5 milligram (mg) capsule orally once daily continuously starting from Day 2 up to Day 15 in each cycle, in schedule 2/1 (2 week on treatment, 1 week off treatment) along with docetaxel 75 milligram/square meter (mg/m^2) intravenous infusion over 1 hour on Day 1 of each cycle and trastuzumab either weekly: loading dose of 4 milligram/kilogram (mg/kg) intravenous infusion over 90 minutes on Day 1 followed by weekly maintenance doses of 2 mg/kg intravenous infusion over 30 minutes; or every 3 weeks: loading dose of 8 mg/kg intravenous infusion over 90 minutes on Day 1 followed by maintenance doses of 6 mg/kg intravenous infusion over 90 minutes every 3 weeks. Cycle length was 3 weeks.
493549|NCT00372411|B4|Baseline|Total|Total of all reporting groups
493550|NCT00372411|B3|Baseline|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493551|NCT00372411|B2|Baseline|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493552|NCT00372411|B1|Baseline|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493553|NCT00372411|P3|Participant Flow|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493554|NCT00372411|P2|Participant Flow|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493555|NCT00372411|P1|Participant Flow|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493556|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493557|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493558|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493559|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493560|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493561|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493562|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493563|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493564|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493565|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493566|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493567|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493568|NCT00372411|O3|Outcome|Usual Care|Usual Care consisted of the usual chronic stroke care as delivered at each participating medical center.
493569|NCT00372411|O2|Outcome|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493570|NCT00372411|O1|Outcome|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
494309|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
493572|NCT00372411|E2|Reported Event|Intensive Comparison Therapy|Intensive comparison therapy consisted of the identical number of treatments, time, and intensity of Robot-assisted therapy (12 weeks, 3 times per week). Each 1-hour therapy session consisted of four successive stages: 1) warm-up and assisted stretching; 2) active arm treatments; 3) goal-directed planar reaching, and 4) functionally based Neurodevelopment Techniques/Bobath arm training.
493573|NCT00372411|E1|Reported Event|Robot-assisted Therapy|Robot-Assisted Therapy uses the MIT-MANUS robot and consists of four modules, shoulder-elbow, anti-gravity, wrist, and hand-unit to train the entire upper limb. Training was given for 12 weeks and was divided into 4 consecutive blocks, with 9 training sessions per block.
493574|NCT00372385|B5|Baseline|Total|Total of all reporting groups
493575|NCT00372385|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493576|NCT00372385|B3|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493577|NCT00372385|B2|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493578|NCT00372385|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493579|NCT00372385|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493580|NCT00372385|P3|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493581|NCT00372385|P2|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493582|NCT00372385|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493583|NCT00372385|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” and “Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
493584|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493585|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493586|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493587|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493588|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493589|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493590|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493783|NCT00371787|P1|Participant Flow|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493784|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
493591|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493592|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493593|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493594|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493595|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493596|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493597|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493598|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493599|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493600|NCT00372385|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493601|NCT00372385|O3|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493602|NCT00372385|O2|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493603|NCT00372385|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493604|NCT00372385|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
493605|NCT00372385|E3|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
493606|NCT00372385|E2|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
493607|NCT00372385|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
493608|NCT00372060|B3|Baseline|Total|Total of all reporting groups
493785|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493786|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
493787|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493788|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
493609|NCT00372060|B2|Baseline|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493610|NCT00372060|B1|Baseline|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493611|NCT00372060|P2|Participant Flow|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493612|NCT00372060|P1|Participant Flow|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493613|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily and who received at least one dose of sitagliptin and were in the CP. This column of data reflects the change from Week 12 at Week 52.
493614|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) orally once daily who were in the CP. This column of data reflects the change from Week 0 at Week 52.
493615|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493616|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493617|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493618|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493619|NCT00372060|O2|Outcome|Placebo / Sitagliptin|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493620|NCT00372060|O1|Outcome|Sitagliptin / Sitagliptin|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin (Weeks 0-52) and pioglitazone (Weeks 0-52) orally once daily. Includes patients who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily. Uptitration of sitagliptin dose was to occur for patients with FPG >140 mg/dL at any time from Week 16 to Week 40 or HbA1c values >7.0% at any time from Week 24 to Week 40. The sitagliptin dose was to have remained stable after Week 40.
493789|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493790|NCT00371787|O2|Outcome|Control Group|normal non-lens wearers
493791|NCT00371787|O1|Outcome|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493792|NCT00371787|E2|Reported Event|Control Group|normal non-lens wearers
493621|NCT00372060|E3|Reported Event|Pooled Sitagliptin (Data Through Week 52)|The Pooled Sitagliptin group includes data from all patients who took sitagliptin in either treatment group. Includes data from Week 0 to Week 52 for patients in the Sitagliptin/Sitagliptin group and data from Week 12 to Week 52 for patients in the Placebo/Sitagliptin group. Includes patients (from either group) who received only sitagliptin 50 mg and those who started on sitagliptin 50 mg and whose dose was subsequently up-titrated to sitagliptin 100 mg orally once daily.
493622|NCT00372060|E2|Reported Event|Placebo/Sitagliptin (Data Through Week 12)|The Placebo/Sitagliptin group includes data from all patients randomized to receive the sequence of placebo (Weeks 0-12) / sitagliptin (Weeks 12-52) orally once daily. This column of data includes only Weeks 0-12.
493623|NCT00372060|E1|Reported Event|Sitagliptin/Sitagliptin (Data Through Week 12)|The Sitagliptin/Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin orally once daily (Weeks 0-52). This column of data includes only Weeks 0-12.
493624|NCT00371865|B3|Baseline|Total|Total of all reporting groups
493625|NCT00371865|B2|Baseline|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493626|NCT00371865|B1|Baseline|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493627|NCT00371865|P2|Participant Flow|Acceptance-Based Therapy|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493628|NCT00371865|P1|Participant Flow|Cognitive Behavioral Therapy|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493629|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493630|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493631|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493632|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493633|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493634|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493635|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493636|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493637|NCT00371865|O2|Outcome|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493638|NCT00371865|O1|Outcome|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493639|NCT00371865|E2|Reported Event|Arm 2|"8 group-administered sessions of Acceptance-based therapy~Acceptance-based therapy: 8 group-administered sessions of Acceptance-based therapy; includes mindfulness, values, and committed action"
493640|NCT00371865|E1|Reported Event|Arm 1|"8 group-administered sessions of Cognitive-Behavioral Therapy~Cognitive-behavioral therapy: 8 group-administered sessions of Cognitive-Behavioral Therapy; includes relaxation, cognitive restructuring, and problem-solving"
493641|NCT00371839|B4|Baseline|Total|Total of all reporting groups
493642|NCT00371839|B3|Baseline|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493643|NCT00371839|B2|Baseline|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493644|NCT00371839|B1|Baseline|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493645|NCT00371839|P3|Participant Flow|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493646|NCT00371839|P2|Participant Flow|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493647|NCT00371839|P1|Participant Flow|Mild HL|"Average hearing loss between 20 and 39 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493648|NCT00371839|O3|Outcome|ModSev HL|"Average hearing loss greater than 50 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493649|NCT00371839|O2|Outcome|Mod HL|"Average hearing loss between 40 and 49 decibels hearing level (HL)~Study performance on cognitive and hearing tests~Audiological Evaluation: Tests of hearing, cognition, and speech perception"
493653|NCT00371826|B3|Baseline|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493654|NCT00371826|B2|Baseline|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493655|NCT00371826|B1|Baseline|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493656|NCT00371826|P3|Participant Flow|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493657|NCT00371826|P2|Participant Flow|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493658|NCT00371826|P1|Participant Flow|Calcineurin Inhibitor (CNI) Withdrawal|Every randomized patient in this group received Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day
493659|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493660|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493661|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493793|NCT00371787|E1|Reported Event|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493794|NCT00371761|B3|Baseline|Total|Total of all reporting groups
493795|NCT00371761|B2|Baseline|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
493662|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493663|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493664|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493665|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493666|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493667|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493668|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493669|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493670|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493796|NCT00371761|B1|Baseline|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
493797|NCT00371761|P2|Participant Flow|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
501665|NCT00350207|O3|Outcome|Placebo|Matching Placebo
493671|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493672|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493673|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493674|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493675|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493676|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493677|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493678|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493679|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493798|NCT00371761|P1|Participant Flow|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
493799|NCT00371761|O2|Outcome|Adefovir|Adefovir, 10 mg daily, for up to 48 weeks followed by a 24-week observation phase
501878|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
493680|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493681|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493682|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493683|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493684|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493685|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493686|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493687|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493688|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493800|NCT00371761|O1|Outcome|PegIntron|PegIntron, 1.5 micrograms/kg weekly, for up to 24 weeks followed by a 48-week observation phase
493801|NCT00371761|E2|Reported Event|Adefovir|
493802|NCT00371761|E1|Reported Event|PegIntron|
493803|NCT00371683|B3|Baseline|Total|Total of all reporting groups
493689|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493690|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493691|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493692|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493693|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493694|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493695|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493696|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493697|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493839|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493840|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days,± 2 days.
493698|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493699|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493700|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493701|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493702|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493703|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493704|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493705|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493706|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493841|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493842|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493707|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493708|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493709|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493710|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493711|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493712|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493713|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493714|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493715|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493843|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493844|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493716|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493717|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493718|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493719|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493720|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493721|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493722|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493723|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493724|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493845|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493846|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
493725|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493726|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493727|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493728|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493729|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493730|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493731|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493732|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493733|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493847|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493848|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493734|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493735|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493736|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493737|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493738|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493739|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493740|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493741|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493742|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493849|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493850|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ±2 days.
493743|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493744|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493745|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493746|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493747|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493748|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493749|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493750|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493751|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493851|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493852|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus placebo tablets BID for 12 days, ± 2 days.
493752|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493753|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493754|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493755|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493756|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493757|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493758|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493759|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493760|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493853|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493854|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
493761|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493762|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493763|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493764|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493765|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493766|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493767|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493768|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493769|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493855|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, ± 2 days.
494180|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
501879|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
493770|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493771|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493772|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493773|NCT00371826|O3|Outcome|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493774|NCT00371826|O2|Outcome|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493775|NCT00371826|O1|Outcome|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493776|NCT00371826|E3|Reported Event|Steroid Withdrawal|"Every randomized patient in this group received Day 1 -14: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve C2 target as per protocol + mycophenolate sodium (MPA) 720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg prednisone per day Day 15 - 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg per day Day 61 - 120: Everolimus dose adjusted + cyclosporine adjust dose according protocol guideline (or commence reduction by day 120 at discretion of Investigator, to be completed within 2 months of commencement) + gradual withdrawal of prednisone by 1 mg/week to be discontinued by Day 120.~Day 121 - Month 36: At Day 121, Month 7 and Month 13 Everolimus dose was adjusted to achieve target 6-10 ng/mL + Cyclosporine adjust dose to achieve C2 target as per protocol"
493777|NCT00371826|E2|Reported Event|CNI+MPA+ Steroid|"Patients randomized to this group received:~Day 1 - Month 36: cyclosporine 5 mg/kg b.i.d., dose adjusted to achieve the protocol defined C2 Targets + mycophenolate sodium 720mg b.i.d. + Methylprednisone/prednisone 500mg intra-operatively, 250mg on day 1, 10-30mg prednisone per day until month 12 (as per local practice), 5-10mg/day months 13-36."
493778|NCT00371826|E1|Reported Event|Calcineurin Inhibitor (CNI) Withdrawal|"Every randomized patient in this group received~Day 1 - Day 14: cyclosporine as Calcineurin Inhibitor (CNI) 5 mg/kg twice daily (b.i.d.), dose adjusted to achieve C2 target of 1,500 ng/mL (range 1,400-1,600 ng/mL) + mycophenolate sodium (MPA)720 mg b.i.d. + methylprednisone/prednisone 500 mg intra-operatively, 250 mg on day 1, then 10-30 mg/day prednisone~Day 15 - Day 60: everolimus 1.5 mg b.i.d. to achieve target 6-10 ng/mL + cyclosporine decrease dose as per protocol guideline + MPA 720 mg b.i.d. until everolimus trough >6 ng/mL, then MPA was stopped + prednisone 10-30mg/day Day 61 - Day 120: everolimus dose adjusted to achieve target 6-10 ng/mL + cyclosporine 25% dose reduction per fortnight, to be discontinued by day 120 as per protocol (or commence reduction by day 120 at discretion of investigator, to be completed within 2 months of commencement) + prednisone 10-30mg/day Day 121 - Month 36: everolimus dose adjusted to achieve target 8-12 ng/mL + prednisone 5-10 mg/day"
493779|NCT00371787|B3|Baseline|Total|Total of all reporting groups
493780|NCT00371787|B2|Baseline|Control Group|normal non-lens wearers
493781|NCT00371787|B1|Baseline|Treatment Group|soft lens wearers with sign of hypoxia and high prescription
493804|NCT00371683|B2|Baseline|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493805|NCT00371683|B1|Baseline|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493806|NCT00371683|P2|Participant Flow|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug(day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493807|NCT00371683|P1|Participant Flow|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug (day of surgery or next day); and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493808|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
493809|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493810|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
493811|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
493812|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493813|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID) plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493814|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
493815|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days,± 2 days.
493816|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
493817|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
493818|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
493819|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
493820|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, plus or minus 2 days.
493821|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
493822|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ± 2 days.
493823|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days.
493824|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493825|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493826|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 h plus matching placebo tablets BID for 12 days, ±2 days.
493827|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493828|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493829|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493830|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493831|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493832|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493833|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493834|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493835|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493836|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493837|NCT00371683|O1|Outcome|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets BID plus matching placebo SC injection q 12 hours for 12 days, ±2 days.
493838|NCT00371683|O2|Outcome|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg SC injection q 12 hours plus matching placebo tablets BID for 12 days, ± 2 days.
493856|NCT00371683|E2|Reported Event|Enoxaparin 30 mg SC Injection q 12 Hours|Enoxaparin 30 mg subcutaneous (SC) injection every (q) 12 hours (h) plus matching placebo tablets BID for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493857|NCT00371683|E1|Reported Event|Apixaban 2.5mg BID|Apixaban 2.5 mg tablets twice a day (BID) plus matching placebo SC injection q 12 hours for 12 days, plus or minus 2 days. The study included a screening period that began no more than 30 days prior to surgery through 24 hours after surgery; a 12 (±2) day treatment period, starting on the day of the first dose of study drug; and a 60 (±3) day follow-up period, starting the day after the last dose of study drug (End of Treatment Period to Day 72).
493858|NCT00371644|B3|Baseline|Total|Total of all reporting groups
493859|NCT00371644|B2|Baseline|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
493860|NCT00371644|B1|Baseline|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
493861|NCT00371644|P2|Participant Flow|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
493862|NCT00371644|P1|Participant Flow|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
493863|NCT00371644|O2|Outcome|Present Centered Therapy (PCT)|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
493864|NCT00371644|O1|Outcome|Cognitive Processing Therapy (CPT)|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
493865|NCT00371644|E2|Reported Event|Arm 2|"Participants receive 12 biweekly sessions of Present Centered Therapy (PCT).~Present-Centered Therapy: PCT consists of general support and education focused on current issues in the patient's life. It emphasizes the focus on the individual's current life, and conceptualizes the problems addressed as manifestations of PTSD that, in some cases, may have been present for long periods of time. Emphasis is on problem solving and improving relationships. Connections are made between current problems and PTSD symptoms. PCT provides the emotional support for the trauma patient that is thought to help in recovery and helps the victim gain a better understanding of the nature of the patient's problems and connection with PTSD."
493866|NCT00371644|E1|Reported Event|Arm 1|"Participants receive 12 biweekly sessions of Cognitive Processing Therapy (CPT).~Cognitive Processing Therapy: CPT is a cognitive therapy based on information processing theory and includes components which help the client to (a) access her or his memory of the event, (b) identify and experience her or his emotions until they have been extinguished, and (c) identify and challenge beliefs about the event itself and beliefs about self and the world which have been altered because of the rape."
493867|NCT00371631|B1|Baseline|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
493868|NCT00371631|P1|Participant Flow|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
493869|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
493870|NCT00371631|O1|Outcome|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
493871|NCT00371631|E1|Reported Event|Treatment Arm|"insertion of E. coli coated catheter~Insertion of urinary catheters coated with E. coli 83972: All patients in this pilot study were in the treatment arm, which consisted of receiving a urinary catheter that had been pre-coated with a biofilm of E. coli."
493872|NCT00371566|B3|Baseline|Total|Total of all reporting groups
493873|NCT00371566|B2|Baseline|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493874|NCT00371566|B1|Baseline|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493875|NCT00371566|P2|Participant Flow|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493876|NCT00371566|P1|Participant Flow|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the institutions standard of care)
493877|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493878|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493879|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493880|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493881|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493882|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493883|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493884|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493885|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493886|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493887|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493888|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493889|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493890|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493891|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493892|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493893|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493894|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493895|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493896|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493949|NCT00371540|P1|Participant Flow|I Routine Care|Routine care in the clinic
493897|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493898|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493899|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493900|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493901|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493902|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493903|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493904|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493905|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493906|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493907|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493908|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493909|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493910|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493911|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493912|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493913|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493914|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493915|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493916|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493917|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493918|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493919|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493920|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493921|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493950|NCT00371540|O2|Outcome|II Home Visits|
493951|NCT00371540|O1|Outcome|I Rountine Care|
493952|NCT00371540|O2|Outcome|II Home Visits|
493922|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493923|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493924|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493925|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493926|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493927|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493928|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493929|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493930|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493931|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493932|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493933|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493934|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493935|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493936|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493937|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493938|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493939|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493940|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493941|NCT00371566|O2|Outcome|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493942|NCT00371566|O1|Outcome|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493943|NCT00371566|E2|Reported Event|Lapatinib|Subjects who were given once daily dose of oral lapatinib 1500 mg for 2 -6 weeks, followed by 4 weeks of standard treatment of radiotherapy (of mor than or equal to 65 Gy) and concurrent platinum-based chemotherapy (based on the institutions standard care).
493944|NCT00371566|E1|Reported Event|Placebo|Subjects who were given Placebo for 2 to 6 weeks followed by 4 weeks of standard treatment of radiotherapy (of more than or equal to 65 Gy) and concurrent platinum-based Chemotherapy (based on the intitutions standard of care)
493945|NCT00371540|B3|Baseline|Total|Total of all reporting groups
493946|NCT00371540|B2|Baseline|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
493947|NCT00371540|B1|Baseline|I Routine Care|Routine care in the clinic
493948|NCT00371540|P2|Participant Flow|II Home Visits|"Follow-up in clinic every 3 months, home visits monthly~Home visit by community care coordinators: Decrease in patient visits to the clinic from the standard of once per month to every 3 months with home visits monthly."
493953|NCT00371540|O1|Outcome|I Rountine Care|
493959|NCT00371462|B2|Baseline|Arm 2|"MOVE! level 2 + Personal Digital Assistant decision support tool (PDA) (Treatment)~MOVE! level 2 group weight loss counseling: Participants will attend the MOVE! group and will be asked to complete assessments at 3, 6, 9, and 12 months."
493960|NCT00371462|B1|Baseline|Arm 1|"MOVE! level 2 group weight loss counseling, the VA standard of care alone (Standard Care);~Use of PDA + support to reduce weight and pain: participants will attend the MOVE! group, record their food, activity, mood, pain, and weight daily via a PDA. Participants will be assigned a coach to help them set physical activity and calorie goals in order to produce a weight loss of .5%-1% per week on average over the course of 6 months. Participants will continue to log using the PDA during the 2nd 6-months for follow-up. They will also be asked to attend assessments at 3, 6, 9, and 12 months."
493961|NCT00371462|P2|Participant Flow|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
493962|NCT00371462|P1|Participant Flow|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
493963|NCT00371462|O2|Outcome|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
493964|NCT00371462|O1|Outcome|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
493965|NCT00371462|E2|Reported Event|Standard-of-care|Participants were provided standard-of-care (participation in VA MOVE program) for weight loss.
493966|NCT00371462|E1|Reported Event|+ Mobile|Participants were provided standard-of-care (participation in VA MOVE program) plus a connective mobile technology system. Participants were provided a personal digital assistant to self-monitor diet and physical activity; they also received biweekly coaching calls for 6 months.
493967|NCT00371449|B1|Baseline|Hearing Aid Users|Hearing aid users
493968|NCT00371449|P1|Participant Flow|Hearing-Aid Users|Individuals who wore hearing aids for > 3 months and at their current setting for at least 1 month
493969|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
493970|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
493971|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
493972|NCT00371449|O1|Outcome|Hearing Aid Users|hearing aid users
493973|NCT00371449|O1|Outcome|Hearing-aid Users|hearing aid users
493974|NCT00371449|O1|Outcome|Group 1|hearing aid users
493975|NCT00371449|E1|Reported Event|Hearing-aid Users|
493976|NCT00371436|B3|Baseline|Total|Total of all reporting groups
493977|NCT00371436|B2|Baseline|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
493978|NCT00371436|B1|Baseline|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
493979|NCT00371436|P2|Participant Flow|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
493980|NCT00371436|P1|Participant Flow|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
493981|NCT00371436|O2|Outcome|Arm 2|"Usual Care~Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic."
493982|NCT00371436|O1|Outcome|Arm 1|"Tinnitus Progressive Management~Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
493983|NCT00371436|E2|Reported Event|Usual Care|Usual Care: Typical audiologic care that would be received in a VA Audiology Clinic.
493984|NCT00371436|E1|Reported Event|Tinnitus Progressive Management|"Tinnitus Progressive Management: The program follows a five-level progressive intervention model that addresses the various needs of tinnitus patients in a systematic and hierarchical manner-from initial contact with a VA provider through long-term treatment. The five levels of progressive intervention are: (1) triage; (2) audiologic evaluation; (3) group education; (4) tinnitus evaluation; and (5) individual management."
493985|NCT00371397|B1|Baseline|Overall Study|Women were exposed to each of the conditions (yoga, movement control, and passive-video control) during three separate visits. The order of the visits was randomized per participant. 52 total participants enrolled.
493986|NCT00371397|P12|Participant Flow|Novice: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
493987|NCT00371397|P11|Participant Flow|Novice: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity."
493988|NCT00371397|P10|Participant Flow|Novice: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
493989|NCT00371397|P9|Participant Flow|Novice: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
493990|NCT00371397|P8|Participant Flow|Novice: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
493991|NCT00371397|P7|Participant Flow|Novice: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga novices, meaning they had participated in yoga classes or practiced at home with yoga videos for 6 - 12 sessions.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
493992|NCT00371397|P6|Participant Flow|Expert: Video Then Hatha Yoga Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day and a 30 minute follow-up session the next morning."
493993|NCT00371397|P5|Participant Flow|Expert: Hatha Yoga Then Movement Control Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga session in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
493994|NCT00371397|P4|Participant Flow|Expert: Movement Control Then Video Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga session in 1 day and a 30 minute follow-up session the next morning."
493995|NCT00371397|P3|Participant Flow|Expert: Video Then Movement Control Then Hatha Yoga|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Hatha Yoga Class in 1 day and a 30 minute follow-up session the next morning."
493996|NCT00371397|P2|Participant Flow|Expert: Hatha Yoga Then Video Then Movement Control|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning."
493997|NCT00371397|P1|Participant Flow|Expert: Movement Control Then Hatha Yoga Then Video|"Participants are female Yoga experts, meaning they have practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.~For Session 1, participants completed the Movement Control Activity in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 2, participants completed the Hatha Yoga Class in 1 day, a 30 minute follow-up session the next morning, followed by 2-4 weeks of normal daily activity.~For Session 3, participants completed the Video Control Activity in 1 day and a 30 minute follow-up session the next morning."
493998|NCT00371397|O2|Outcome|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
493999|NCT00371397|O1|Outcome|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
494000|NCT00371397|E2|Reported Event|Expert|Women were classified as Experts if they had practiced yoga regularly 1-2 times per week (75-90 min sessions) for at least 2 years, and at least 2 times per week for the past year.
494001|NCT00371397|E1|Reported Event|Novice|Women were classified as novices if they had participated in yoga classes or home practice with yoga videos for 6 - 12 sessions.
494002|NCT00371345|B3|Baseline|Total|Total of all reporting groups
494003|NCT00371345|B2|Baseline|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494004|NCT00371345|B1|Baseline|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494005|NCT00371345|P2|Participant Flow|ER and/or PgR Positive Tumor Type|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494006|NCT00371345|P1|Participant Flow|Her2/Neu-amplified Tumor Type|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494007|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494008|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494009|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494010|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494011|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494012|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494013|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494014|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494015|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494016|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494017|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494018|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494019|NCT00371345|O3|Outcome|Dasatinib 50 mg|Dasatinib was administered orally at a starting dose of 70 mg BID. Dose adjustment was made according to tolerance, with reduction to 50 mg BID. Participants continued study treatment until PD or unacceptable toxicity. Dasatinib dose was adjusted so that drug-related toxicities were either Grade 0 - 1 or were Grade 2 toxicities that were adequately managed with outpatient therapy or deemed clinically acceptable.
494020|NCT00371345|O2|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494021|NCT00371345|O1|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494022|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494023|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494024|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494025|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494026|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494027|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494028|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494029|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494030|NCT00371345|O2|Outcome|Dasatinib 100 mg|Dasatinib was administered orally at 100 mg BID, for a total daily dose (TDD) of 200 mg.
494031|NCT00371345|O1|Outcome|Dasatinib 70 mg|Dasatinib was administered orally at 70 mg BID, for a TDD of 140 mg.
494032|NCT00371345|O3|Outcome|Participant CA180088-29-88085, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 70 mg dasatinib BID
494033|NCT00371345|O2|Outcome|Participant CA180088-16-88002, ER and/or PgR Group|Participant with ER and PgR–amplified tumor type who received 100 mg dasatinib BID
494034|NCT00371345|O1|Outcome|Participant CA180088-18-88009, HER-2 Group|Participant with Human epidermal growth factor (Her2/neu)–amplified tumor type (also positive for ER and PgR) who received 100 mg dasatinib BID.
494181|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494035|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494036|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494037|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494038|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494039|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
494040|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
494041|NCT00371345|O3|Outcome|All Participants|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
494042|NCT00371345|O2|Outcome|ER and/or PgR Positive Tumor|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally dasatinib twice daily (BID).
494043|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally dasatinib twice daily (BID).
494044|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494045|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494046|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494047|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494048|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494049|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494050|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494051|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494052|NCT00371345|O5|Outcome|All Response-evaluable Participants|Evaluable population (n=69): Response Evaluable=treated participants with ≥1 measurable lesion at baseline and ≥1 on-study tumor assessment; Non-responders=treated participants with no on-study tumor response assessment due to rapid disease progression/dasatinib toxicity. One participant was not evaluable (no on-study tumor assessment).
494053|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494054|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494055|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
501880|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
494056|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494057|NCT00371345|O4|Outcome|ER and/or PgR Positive Tumor, 100 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494058|NCT00371345|O3|Outcome|ER and/or PgR Positive Tumor, 70 mg BID Dasatinib|Participants with ER and/or PgR positive tumor types (defined as >10% of cells positive by IHC [unless Her2/neu–amplified]) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494059|NCT00371345|O2|Outcome|Her2/Neu-amplified Tumor, 100 mg BID|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 100 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 200 mg.
494060|NCT00371345|O1|Outcome|Her2/Neu-amplified Tumor, 70 mg Twice Daily (BID) Dasatinib|Participants with a Human epidermal growth factor (Her2/neu)–amplified tumor type (defined as 3+ by immunohistochemistry [IHC] or positive by fluorescent or chromogenic in situ hybridization [FISH or CISH] regardless of estrogen receptor [ER]/progesterone receptor [PgR] status) received orally 70 mg of dasatinib twice daily (BID) for a total daily dose (TDD) of 140 mg.
494061|NCT00371345|E1|Reported Event|Dasatinib|Dasatinib was administered orally at 70 mg BID (TDD=140 mg) or 100 mg BID (TDD=200 mg).
494062|NCT00371267|B3|Baseline|Total|Total of all reporting groups
494063|NCT00371267|B2|Baseline|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494064|NCT00371267|B1|Baseline|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494065|NCT00371267|P2|Participant Flow|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494066|NCT00371267|P1|Participant Flow|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494067|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494068|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494069|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494070|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494071|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494072|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494073|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494074|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494075|NCT00371267|O2|Outcome|Arm 2: Telephone Patient Education|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494076|NCT00371267|O1|Outcome|Arm 1: Telephone CBT|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494077|NCT00371267|E2|Reported Event|Arm 2|"Telephone-delivered patient education regarding management of chronic pain~Pain Education: Telephone-delivered education regarding chronic pain"
494078|NCT00371267|E1|Reported Event|Arm 1|"Telephone-delivered cognitive behavior therapy for pain management~Cognitive Behavior Therapy: Telephone-delivered cognitive behavior therapy for pain management"
494079|NCT00371254|B3|Baseline|Total|Total of all reporting groups
494080|NCT00371254|B2|Baseline|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494081|NCT00371254|B1|Baseline|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494082|NCT00371254|P2|Participant Flow|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494182|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494183|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494083|NCT00371254|P1|Participant Flow|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494084|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494085|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494086|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494087|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494088|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494089|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494090|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494091|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494092|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494093|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494094|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494095|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494096|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494097|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494098|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494099|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494100|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494101|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494102|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494103|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494104|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494105|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494106|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494107|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494108|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494109|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494110|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494111|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494112|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494113|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494114|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494115|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494116|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494117|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494118|NCT00371254|O3|Outcome|Dasatinib 50 mg BID|Participants were administered an oral dose of 50 mg dasatinib tablet twice daily for a total daily dose (TDD) of 100 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494119|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494120|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494121|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494122|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494123|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494124|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494125|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494126|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494127|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494128|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494129|NCT00371254|O2|Outcome|Dasatinib 70 mg BID|Participants were administered an oral dose of 70 mg dasatinib tablet twice daily for a TDD of 140 mg. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494184|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494185|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494186|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494130|NCT00371254|O1|Outcome|Dasatinib 100 mg BID|Participants were administered an oral dose of 100 mg dasatinib tablet twice daily for a total daily dose (TDD) of 200 mg. Study treatment continued for as long as it was tolerated, or until progressive disease (PD), defined as appearance of new lesion/s, or >=20% increase in the sum of the longest diameter (LD) of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494131|NCT00371254|E1|Reported Event|All Participants|All treated participants who were administered a twice-daily oral dose of either 100 mg (TDD 200 mg) or 70 mg (TDD 140 mg) dasatinib tablet. Study treatment continued for as long as it was tolerated, or until PD, defined as appearance of new lesion/s, or >=20% increase in the sum of the LD of target lesions, relative to the smallest sum LD recorded since treatment start, or unequivocal progression of existing non-target lesions.
494132|NCT00371176|B3|Baseline|Total|Total of all reporting groups
494133|NCT00371176|B2|Baseline|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494134|NCT00371176|B1|Baseline|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494135|NCT00371176|P2|Participant Flow|Placebo Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a placebo pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
494136|NCT00371176|P1|Participant Flow|D-Cycloserine Plus Exposure|Treatment entailed six 60-90 minute sessions. Session 1 focused on psychoeducation and building of rapport, sessions 2-5 of brief imaginal exposure therapy plus a 50 mg DCS pill 30 minutes prior to each session, and session 6 consisted of a review of treatment gains, discussion of relapse-prevention strategies, and termination.
494137|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494138|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494139|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494140|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494141|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494142|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494143|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494144|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494145|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494146|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494147|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494148|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494149|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494150|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494151|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494152|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494153|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494154|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494155|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494156|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494157|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494158|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494159|NCT00371176|O2|Outcome|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494160|NCT00371176|O1|Outcome|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494161|NCT00371176|E2|Reported Event|Placebo Plus Exposure|Brief imaginal exposure therapy plus Placebo pill
494162|NCT00371176|E1|Reported Event|D-Cycloserine Plus Exposure|Brief imaginal exposure therapy plus DCS pill
494163|NCT00371150|B3|Baseline|Total|Total of all reporting groups
494164|NCT00371150|B2|Baseline|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494165|NCT00371150|B1|Baseline|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494166|NCT00371150|P2|Participant Flow|Hispanic|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494167|NCT00371150|P1|Participant Flow|Black/ African American|Entecavir (ETV) tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494168|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494169|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494170|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494171|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494172|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494173|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494174|NCT00371150|O3|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494175|NCT00371150|O2|Outcome|Hispanic|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494176|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494177|NCT00371150|O2|Outcome|Total|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494178|NCT00371150|O1|Outcome|Black / African American|Entecavir tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494179|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494187|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494188|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494189|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494190|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494191|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494192|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494193|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494194|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494195|NCT00371150|O2|Outcome|Total|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks (Includes 6 participants of the Hispanic cohort)
494196|NCT00371150|O1|Outcome|Black / African American|ETV tablets, Oral, 0.5 mg, once daily, up to 52 weeks
494197|NCT00371150|E1|Reported Event|Entecavir (ETV)|Entecavir tablets, Oral, 0.5 mg, once daily, up to 48 weeks (Includes 6 participants of the Hispanic cohort)
494198|NCT00371137|B4|Baseline|Total|Total of all reporting groups
494199|NCT00371137|B3|Baseline|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
494200|NCT00371137|B2|Baseline|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
494201|NCT00371137|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
494202|NCT00371137|P3|Participant Flow|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
494203|NCT00371137|P2|Participant Flow|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
494204|NCT00371137|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
494205|NCT00371137|O3|Outcome|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
494206|NCT00371137|O2|Outcome|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
494207|NCT00371137|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
494208|NCT00371137|E3|Reported Event|Xyrem 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
494209|NCT00371137|E2|Reported Event|Xyrem 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
494210|NCT00371137|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
494211|NCT00370994|B3|Baseline|Total|Total of all reporting groups
494212|NCT00370994|B2|Baseline|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494213|NCT00370994|B1|Baseline|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494214|NCT00370994|P2|Participant Flow|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494215|NCT00370994|P1|Participant Flow|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution.
494216|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494217|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
494218|NCT00370994|O2|Outcome|Intervention Group|adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494219|NCT00370994|O1|Outcome|Control Group|caudal epidural injections since no adhesiolysis was performed and there was no injection of 10% sodium chloride solution.
494220|NCT00370994|E2|Reported Event|Pecutaneous Adhesiolysis|Pecutaneous adhesiolysis and targeted placement of Racz catheter with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 10% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494221|NCT00370994|E1|Reported Event|Caudal Epidural Injection|Caudal epidural with placement of catheter in sacral canal with injection of 5 mL of 2% preservative-free lidocaine, followed by 6 mL of 0.9% sodium chloride solution and 6 mg of non-particulate Betamethasone and 1 mL of sodium chloride solution
494222|NCT00370838|B3|Baseline|Total|Total of all reporting groups
494223|NCT00370838|B2|Baseline|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
494236|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494224|NCT00370838|B1|Baseline|Levetiracetam First, Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
494225|NCT00370838|P2|Participant Flow|Clonidine First, Then Levetiracetam|"Participants first received clonidine, packaged in look-alike capsules: starting dose was 0.05 milligram (mg) twice a day, if needed, the dose increased weekly by 0.05-0.1 mg. The maximum dose was 0.4 mg (0.2 mg twice a day (BID)).~In the second period, participants received levetiracetam: starting dose of 10 mg/killigram(kg)/day, increased weekly by 5-10 mg/kg/day, to a maximum of 50 mg/kg/day (25 mg/kg BID; 2,500 mg per day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
494226|NCT00370838|P1|Participant Flow|First Levetiracetam Then Clonidine|"Participants first received levetiracetam: starting dose of 10 milligram/killigram/day, increased weekly by 5-10 milligram/killigram/day, to a maximum of 50 milligram/killigram/day (25 milligram/killigram twice a day; 2,500 mg per day).~In the second period, participants received clonidine (days 65-107), packaged in look-alike capsules: starting dose was 0.05 milligrams twice a day, if needed, the dose increased weekly by 0.05-0.1 milligrams. The maximum dose was 0.4 milligrams (0.2 milligrams twice a day).~Wash out phase: Between the two treatment phases, medication tapered over a ten day period: levetiracetam by 5-10 mg/kg/day every third day; clonidine by 0.05 - 0.1 mg every third day. Subjects were off medication for 5 days before starting the second phase of the cross over study.~Taper: After the two treatment phases, medication tapered over a ten day period as in Wash-out phase (see above)."
494227|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494228|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494229|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494230|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494231|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494232|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494233|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494234|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494235|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494295|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494237|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494238|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494239|NCT00370838|O2|Outcome|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494240|NCT00370838|O1|Outcome|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494241|NCT00370838|E2|Reported Event|Clonidine|Participants received clonidine in either the first or second phase of the study. The initial dose of clonidine was 0.05 mg, twice daily. If needed for tic suppression, the dose was increased weekly by 0.05-0.1 mg, with a maximum dose of 0.4 mg per day. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494242|NCT00370838|E1|Reported Event|Levetiracetam|Participants received levetiracetam in either first or second period of this study. The initial dose of levetiracetam was 10 mg/kg/day, divided twice daily (rounded to the closest unit of 250 mg). The dose was increased weekly by 5-10 mg/kg/day, to a maximum dose of 50 mg/kg/day (or 2,500 mg/day), if deemed necessary for tic suppression. In any individual, dose escalation may have proceeded more slowly, or the dose may have been reduced as necessary. No changes in dosage occurred during the final week of either treatment phase.
494243|NCT00370552|B4|Baseline|Total|Total of all reporting groups
494244|NCT00370552|B3|Baseline|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494245|NCT00370552|B2|Baseline|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494246|NCT00370552|B1|Baseline|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494247|NCT00370552|P3|Participant Flow|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494248|NCT00370552|P2|Participant Flow|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494249|NCT00370552|P1|Participant Flow|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494250|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494296|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494297|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494251|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494252|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494253|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494254|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494255|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494256|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494257|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494258|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494259|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494260|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494261|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494262|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494298|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494299|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494300|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494301|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494302|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494263|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494264|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494265|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494266|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494267|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494268|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494269|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494270|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494271|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494272|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494273|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494274|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494303|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494304|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494305|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494306|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
501881|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
494275|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494276|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494277|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494278|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494279|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494280|NCT00370552|O3|Outcome|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494281|NCT00370552|O2|Outcome|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494282|NCT00370552|O1|Outcome|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494283|NCT00370552|E3|Reported Event|Paclitaxel, 90 mg/m^2 + Bevacizumab, 10 mg/kg|Paclitaxel, 90 mg/m^2, given as a 1-hour IV infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered as IV infusion every 2 weeks. Bevacizumab infused over 90 minutes for the first dose, and if well tolerated, over 60 minutes for the second dose. If still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494284|NCT00370552|E2|Reported Event|Ixabepilone, 40 mg/m^2 + Bevacizumab, 15 mg/kg|Ixabepilone, 40 mg/m^2, administered as a 3-hour IV infusion on Day 1 of a 21-day cycle until disease progression or unacceptable toxicity. After Cycle 4, dose reduction to 32 mg/m^2 implemented for all subsequent cycles. Bevacizumab, 15 mg/kg, administered after ixabepilone, as IV infusion every 3 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494285|NCT00370552|E1|Reported Event|Ixabepilone, 16 mg/m^2 + Bevacizumab, 10 mg/kg|Ixabepilone,16 mg/m^2, administered as a 1-hour intravenous (IV) infusion on Days 1, 8, and 15 of a 28-day cycle until disease progression or unacceptable toxicity. Bevacizumab, 10 mg/kg, administered after ixabepilone, as IV infusion every 2 weeks. Bevacizumab to be infused over 90 minutes for the first dose, and if well tolerated for 60 minutes, for the second dose. Then if still tolerated, over 30 minutes for subsequent infusions. Bevacizumab was to be dosed until disease progression or unacceptable toxicity.
494286|NCT00370331|B3|Baseline|Total|Total of all reporting groups
494287|NCT00370331|B2|Baseline|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494288|NCT00370331|B1|Baseline|Placebo|Matching placebo tablets taken once a day
494289|NCT00370331|P2|Participant Flow|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494290|NCT00370331|P1|Participant Flow|Placebo|Matching placebo tablets taken once a day
494291|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494292|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494293|NCT00370331|O2|Outcome|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494294|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494310|NCT00370331|O1|Outcome|Placebo|Matching placebo tablets taken once a day
494311|NCT00370331|E2|Reported Event|Eltrombopag 50 mg QD|Eltrombopag 50 mg oral tablets taken once a day (QD)
494312|NCT00370331|E1|Reported Event|Placebo|Matching placebo tablets taken once a day
494313|NCT00370292|B3|Baseline|Total|Total of all reporting groups
494314|NCT00370292|B2|Baseline|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
494315|NCT00370292|B1|Baseline|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
494316|NCT00370292|P1|Participant Flow|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
494317|NCT00370292|O3|Outcome|hENT - Cycle 3|Mean hENT expression evaluated at Cycle 3.
494318|NCT00370292|O2|Outcome|hENT - Cycle 2|Mean hENT expression evaluated at Cycle 2.
494319|NCT00370292|O1|Outcome|hENT - Cycle 1|Mean hENT expression evaluated at Cycle 1.
494320|NCT00370292|O2|Outcome|Pemetrexed - After Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 21 days x 6 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
494321|NCT00370292|O1|Outcome|Pemetrexed - Before Amendment|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles or disease progression, unacceptable toxicity or patient decision to discontinue.
494322|NCT00370292|O3|Outcome|dCK - Cycle 3|Mean dCK expression evaluated at Cycle 3.
494323|NCT00370292|O2|Outcome|dCK - Cycle 2|Mean dCK expression evaluated at Cycle 2.
494324|NCT00370292|O1|Outcome|dCK - Cycle 1|Mean dCK expression evaluated at Cycle 1.
494325|NCT00370292|E1|Reported Event|Pemetrexed|500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles (pre-amendement) or 21 days x 6 cycles (post-amendment) or disease progression, unacceptable toxicity or patient decision to discontinue.
494326|NCT00370149|B3|Baseline|Total|Total of all reporting groups
494327|NCT00370149|B2|Baseline|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J RSC).
494328|NCT00370149|B1|Baseline|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were sized to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM) and C-UDLM-401J-ABRM-HC), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC).
494329|NCT00370149|P2|Participant Flow|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to this arm had the conventional Central Venous Catheter (C/S) with no antibiotic coating inserted intraoperatively. The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), and 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
494330|NCT00370149|P1|Participant Flow|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation. Patients randomized to M/R had the catheter impregnated with minocycline and rifampin (M/R) inserted intraoperatively. The specific Central Venous Catheters are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
494331|NCT00370149|O2|Outcome|Conventional Non-impegnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J) 5 Fr.,12 cm long, (C-UDLM-501J-RSC).
494332|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
494333|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
494334|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two sizes to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), ), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC) or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
494335|NCT00370149|O2|Outcome|Conventional Non-impregnated Catheters (C/S)|Patients randomized to this arm had the C/S inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1 C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Double Lumen Polyurethane Central Venous Catheters,4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), or 5 Fr., 12 cm long, (C-UDLM-501J-RSC).
494336|NCT00370149|O1|Outcome|Antibiotic Impregnated Catheters (M/R)|Patients randomized to this arm had the M/R inserted intra-operatively as determined by the blinded randomization procedure (1M/R: 1C/S). The catheters were one of two to accommodate children in different size ranges: Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr. 8 cm long, (C-UDLM-501J-ABRM-HC), or 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM).
494337|NCT00370149|E2|Reported Event|Conventional Non-impregnated Catheters (C/S)|Randomization to 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if there was a therapeutic difference between the M/R and C/S catheters. Patients randomized to this arm had the C/S inserted intra-operatively. Patients receiving this catheter were enrolled in the study.The specific catheters are the Cook Incorporated Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J), 5 Fr., 8 cm long, (C-UDLM-501J), 5 Fr., 12 cm long, (C-UDLM-501J-RSC). Patients were followed for adverse device affects and adverse events through their hospitalization stay
494338|NCT00370149|E1|Reported Event|Antibiotic Impregnated Catheters (M/R)|Randomization to the 2 arms of the study were on a blinded a 1:1 allocation with the objective of determining if a therapeutic difference existed between M/R and C/S catheters. Patients randomized to this Arm had the M/R catheter inserted intra-operatively. Patients receiving this Catheter were enrolled in the study. The specific CVCs are the Cook Incorporated Spectrum Double Lumen Polyurethane Central Venous Catheters, 4 Fr., 8 cm long, (C-UDLM-401J-ABRM), 5 Fr., 8 cm long, (C-UDLM-501J-ABRM-HC), and 5 Fr., 12 cm long, (C-UDLMY-501J-RSC-ABRM-HC). Patients were followed for adverse device affects and adverse events through their hospitalization stay.
494339|NCT00370071|B1|Baseline|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 micrograms (8 MIU [million international units]) subcutaneously every other day.
494340|NCT00370071|P1|Participant Flow|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494341|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494342|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494343|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494344|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494345|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494346|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494347|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494348|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494349|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494350|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494351|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494352|NCT00370071|O1|Outcome|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494353|NCT00370071|E1|Reported Event|Interferon Beta-1b (Betaseron, BAY86-5046)|Interferon beta-1b 250 μg (8 MIU) subcutaneously (sc) every other day (e.o.d.)
494354|NCT00370032|B3|Baseline|Total|Total of all reporting groups
494355|NCT00370032|B2|Baseline|Healthy Volunteers|Volunteers without clinical disease. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
494356|NCT00370032|B1|Baseline|d-IBS|Diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mb BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another wash out period and a 7 day follow up period.
494357|NCT00370032|P2|Participant Flow|Healthy Volunteers|Subjects with no clinical disease. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by flexible sigmoidoscopy then had a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
494358|NCT00370032|P1|Participant Flow|d-IBS (Diarrhea Predominant - Irritable Bowel Syndrome)|Subjects with diarrhea-predominant irritable bowel syndrome. This group was randomize to EITHER 0.5 mg BID Alosetron or Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then the subjects who were given study drug the first treatment period were given Placebo and vice versa for the next 6 days followed by a flexible sigmoidoscopy then had a 7 day follow up period.
494359|NCT00370032|O4|Outcome|Healthy Volunteers Placebo - Rectal|Subjects without clinical disease. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
494360|NCT00370032|O3|Outcome|Healthy Volunteers Placebo - Left Colon|Subjects without Clinical disease. Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
494361|NCT00370032|O2|Outcome|d-IBS Placebo - Rectal|Subjects with diarrhea-predominant irritable bowel syndrome. Modified per protocol. Subjects Rectal Mucosal blow flow under placebo.
494362|NCT00370032|O1|Outcome|d-IBS Placebo - Left Colon|Subjects with diarrhea-predominant irritable bowel syndrome . Modified per protocol. Subjects Left Colon Mucosal blow flow under placebo.
494363|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
494364|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
494365|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
494366|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
494367|NCT00370032|O4|Outcome|Healthy Volunteers Alosetron|Subjects without clinical disease. In Treatment Period 1 this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then,in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
494368|NCT00370032|O3|Outcome|Healthy Volunteers Placebo|Subjects without Clinical disease. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
494369|NCT00370032|O2|Outcome|d-IBS Alosetron|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1, this group was randomized to 0.5 mb BID Alosetron for 5days and 1 dose on the 6th day followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Placebo for the next 6 days followed by another 7 day wash out period and a 7 day follow up period.
494370|NCT00370032|O1|Outcome|d-IBS Placebo|Subjects with diarrhea-predominant irritable bowel syndrome. In Treatment Period 1 this group was first randomized to Placebo for 6 days followed by a flexible sigmoidoscopy; followed by a 7 day washout period; Then, in Treatment Period 2 the subjects were given Alosetron 0.5 mg (BID)for 5 days and on the 6th day one dose and a flexible sigmoidoscopy; followed by another wash out period of 7 days and a 7 day follow up period.
494371|NCT00370032|E4|Reported Event|Healthy Volunteers Alosetron|Volunteers without clinical disease. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
494372|NCT00370032|E3|Reported Event|Healthy Volunteers Placebo|Volunteers without clinical disease. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
494373|NCT00370032|E2|Reported Event|d-IBS Alosetron|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Alosetron BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
494374|NCT00370032|E1|Reported Event|d-IBS Placebo|Diarrhea-predominant irritable bowel syndrome. Participants receiving 0.5 mb Placebo BID in either the first or second 6-day treatment period. Both treatment periods were followed by a 7-day washout period; the second washout period was followed by a 7-day follow up period.
494375|NCT00369967|B3|Baseline|Total|Total of all reporting groups
494376|NCT00369967|B2|Baseline|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494377|NCT00369967|B1|Baseline|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494378|NCT00369967|P2|Participant Flow|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494379|NCT00369967|P1|Participant Flow|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494380|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494381|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494382|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494383|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494384|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494385|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494386|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494387|NCT00369967|O1|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494388|NCT00369967|O2|Outcome|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494389|NCT00369967|O1|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494390|NCT00369967|O2|Outcome|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception
494391|NCT00369967|O1|Outcome|Quick Start|"Start method day of enrollment~NuvaRing: Initiation of NuvaRing for contraception"
494392|NCT00369967|E2|Reported Event|Quick Start|NuvaRing: Initiation of NuvaRing for contraception on day of enrollment
494393|NCT00369967|E1|Reported Event|Traditional Start|NuvaRing: Initiation of NuvaRing for contraception per package insert
494394|NCT00369941|B3|Baseline|Total|Total of all reporting groups
494395|NCT00369941|B2|Baseline|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494564|NCT00369915|P1|Participant Flow|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
494565|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
494396|NCT00369941|B1|Baseline|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494397|NCT00369941|P2|Participant Flow|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494398|NCT00369941|P1|Participant Flow|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494399|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494400|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494401|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494402|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494403|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494404|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494405|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494406|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494407|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494408|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494409|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494566|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
494567|NCT00369915|O2|Outcome|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
501882|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
494410|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494411|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494412|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494413|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494414|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494415|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494416|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494417|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494418|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494419|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494420|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494421|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494422|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494423|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494568|NCT00369915|O1|Outcome|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
494569|NCT00369915|E2|Reported Event|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
501883|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
494424|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494425|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494426|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494427|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494428|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494429|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494430|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494431|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494432|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494433|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494434|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494435|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494436|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494437|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494570|NCT00369915|E1|Reported Event|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
494571|NCT00369824|B7|Baseline|Total|Total of all reporting groups
494572|NCT00369824|B6|Baseline|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
501884|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
494438|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494439|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494440|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494441|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494442|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494443|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494444|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494445|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494446|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494447|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494448|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494449|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494450|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494451|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494573|NCT00369824|B5|Baseline|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494574|NCT00369824|B4|Baseline|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494575|NCT00369824|B3|Baseline|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494452|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494453|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494454|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494455|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494456|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494457|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494458|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494459|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494460|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494461|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494462|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494463|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494464|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494465|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494576|NCT00369824|B2|Baseline|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494577|NCT00369824|B1|Baseline|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
501885|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
494466|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494467|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494468|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494469|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494470|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494471|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494472|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494473|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494474|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494475|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494476|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494477|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494478|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494479|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494578|NCT00369824|P6|Participant Flow|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494579|NCT00369824|P5|Participant Flow|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494580|NCT00369824|P4|Participant Flow|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494480|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494481|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494482|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494483|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494484|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494485|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494486|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494487|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494488|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494489|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494490|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494491|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494492|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494493|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494581|NCT00369824|P3|Participant Flow|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494582|NCT00369824|P2|Participant Flow|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
501886|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
494494|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494495|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494496|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494497|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494498|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494499|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494500|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494501|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494502|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494503|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494504|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494505|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494506|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494507|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494583|NCT00369824|P1|Participant Flow|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494584|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494585|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494508|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494509|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494510|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494511|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494512|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494513|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494514|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494515|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494516|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494517|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494518|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494519|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494520|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494521|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494586|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494587|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494591|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494522|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494523|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494524|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494525|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494526|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494527|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494528|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494529|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494530|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494531|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494532|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494533|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494534|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494535|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494588|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494589|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494590|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494536|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494537|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494538|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494539|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494540|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494541|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494542|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494543|NCT00369941|O2|Outcome|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg, which will be taken by mouth (PO) at bedtime (q.h.s.) on an empty stomach preferably at bedtime, and placebo to MK-0518, which will be taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494544|NCT00369941|O1|Outcome|MK-0518 400 mg b.i.d.|MK-0518 400 mg, which can be taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, which will be taken PO at bedtime (q.h.s.) on an empty stomach preferably at bedtime. All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) with food, daily with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494545|NCT00369941|E2|Reported Event|Efavirenz 600 mg q.h.s.|Efavirenz 600 mg taken by mouth on an empty stomach preferably at bedtime (q.h.s.), and placebo to MK-0518 taken PO twice a day (b.i.d.) without regard to food. All participants will take one tablet of TRUVADA® with food, daily with the morning dose of placebo. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494546|NCT00369941|E1|Reported Event|MK-0518 400 mg b.i.d.|MK-0518 400 mg taken by mouth (PO) twice a day (b.i.d.) without regard to food, and placebo to efavirenz, taken PO (q.h.s.) on an empty stomach preferably at bedtime (q.h.s.). All participants will take one tablet of TRUVADA® (200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate) daily with food with the morning dose of MK-0518. Dosing interval adjustment of TRUVADA® is recommended in all participants with creatinine clearance 30-49 mL/min.
494547|NCT00369928|B4|Baseline|Total|Total of all reporting groups
494548|NCT00369928|B3|Baseline|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
494549|NCT00369928|B2|Baseline|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
494550|NCT00369928|B1|Baseline|Placebo|Placebo, oral dose, BID
494551|NCT00369928|P3|Participant Flow|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
494552|NCT00369928|P2|Participant Flow|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
494553|NCT00369928|P1|Participant Flow|Placebo|Placebo, oral dose, BID
494554|NCT00369928|O3|Outcome|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
494555|NCT00369928|O2|Outcome|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
494556|NCT00369928|O1|Outcome|Placebo|Placebo, oral dose, BID
494557|NCT00369928|E3|Reported Event|100 mg PG-760564 BID|100 mg BID, of oral PG-760564
494558|NCT00369928|E2|Reported Event|25 mg PG-760564 BID|25 mg BID, of oral PG-760564
494559|NCT00369928|E1|Reported Event|Placebo|Placebo, oral dose, BID
494560|NCT00369915|B3|Baseline|Total|Total of all reporting groups
494561|NCT00369915|B2|Baseline|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
494562|NCT00369915|B1|Baseline|Plac/Scop|6 administrations of placebo patch at 4 to 5 day intervals; followed by 6 administrations of scopolamine patch at 4 to 5 day intervals
494563|NCT00369915|P2|Participant Flow|Scop/Plac|6 administrations of scopolamine patch at 4 to 5 day intervals; followed by 6 administrations of placebo patch at 4 to 5 day intervals
494592|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494593|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494594|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494595|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494596|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494597|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494598|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494599|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494600|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494601|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494602|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494603|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494604|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494605|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494606|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494607|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494608|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494609|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494610|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494611|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494612|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494613|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494614|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494615|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494616|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494617|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494618|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494619|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494620|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494621|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494622|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494623|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494624|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494625|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494626|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494627|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494628|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494629|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494630|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494631|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494632|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494633|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494634|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494635|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494636|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494637|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494638|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494639|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494640|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494641|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494642|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494643|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494644|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494645|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494646|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494647|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494648|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494649|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494650|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494651|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494652|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494653|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494654|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494655|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494656|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494657|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494658|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494659|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494660|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494661|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494662|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494663|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494664|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494665|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494666|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494667|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494668|NCT00369824|O6|Outcome|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494669|NCT00369824|O5|Outcome|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494670|NCT00369824|O4|Outcome|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494671|NCT00369824|O3|Outcome|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494672|NCT00369824|O2|Outcome|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494673|NCT00369824|O1|Outcome|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494674|NCT00369824|E6|Reported Event|Cervarix Group|Subjects received Cervarix at Months 0, 1 and 6.
494675|NCT00369824|E5|Reported Event|Menactra/Cervarix Group|Subjects received Menactra at Month 0 and Cervarix at Months 1, 2 and 7.
494676|NCT00369824|E4|Reported Event|Boostrix/Cervarix Group|Subjects received Boostrix at Month 0 and Cervarix at Months 1, 2 and 7.
494677|NCT00369824|E3|Reported Event|Cervarix + Boostrix + Menactra Group|Subjects received Boostrix, Menactra and Cervarix at Month 0 and Cervarix alone at Months 1 and 6.
494678|NCT00369824|E2|Reported Event|Cervarix + Menactra/Boostrix Group|Subjects received Menactra and Cervarix at Month 0, Boostrix and Cervarix at Month 1 and Cervarix alone at Month 6.
494679|NCT00369824|E1|Reported Event|Cervarix + Boostrix/Menactra Group|Subjects received Cervarix and Boostrix at Month 0, Menactra and Cervarix at Month 1 and Cervarix alone at Month 6.
494680|NCT00369746|B3|Baseline|Total|Total of all reporting groups
494681|NCT00369746|B2|Baseline|Major Depression Only|Major Depression without alcohol abuse disorder
494682|NCT00369746|B1|Baseline|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
494683|NCT00369746|P2|Participant Flow|Major Depression Only|Major Depression without alcohol abuse disorder
494684|NCT00369746|P1|Participant Flow|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence and Major Depression
494685|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
494686|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
494687|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
494688|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
494689|NCT00369746|O2|Outcome|Major Depression Only|citalopram (Non alcoholic)
494690|NCT00369746|O1|Outcome|Alcoholic|Subjects with alcohol abuse or dependence
494691|NCT00369746|E2|Reported Event|Major Depression Only|Major Depression without alcohol abuse disorder
494692|NCT00369746|E1|Reported Event|Alcohol Abuse or Dependence|Subjects with alcohol abuse or dependence
494693|NCT00369681|B1|Baseline|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
494694|NCT00369681|P1|Participant Flow|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
494695|NCT00369681|O1|Outcome|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
494696|NCT00369681|O2|Outcome|Re-emergence of Clone|Participants who did have re-emergence of clonal CD27(+) ALDH(+) B cells
494697|NCT00369681|O1|Outcome|No Clone|Participants who did not have re-emergence of clonal CD27(+) ALDH(+) B cells
494698|NCT00369681|E1|Reported Event|R-ABVD|ABVD (Adriamycin/doxorubicin; vinblastine; bleomycin; dacarbazine) given as standard for 6-8 cycles. Rituximab given 375 mg/m^2 Cycle 1 Days -6, 1, 8, 15, and 22. Rituximab given 375 mg/m^2 Cycles 2, 4, and 6 Day 1.
494699|NCT00369668|B4|Baseline|Total|Total of all reporting groups
494700|NCT00369668|B3|Baseline|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
494701|NCT00369668|B2|Baseline|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
494702|NCT00369668|B1|Baseline|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
494703|NCT00369668|P3|Participant Flow|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
494704|NCT00369668|P2|Participant Flow|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
494705|NCT00369668|P1|Participant Flow|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
494706|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
494707|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
494708|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
494709|NCT00369668|O3|Outcome|Control|Bilateral movements coupled with sham neuromuscular electrical stimulation. Two times per week for two weeks.
494710|NCT00369668|O2|Outcome|Low Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Two times per week for two weeks.
494711|NCT00369668|O1|Outcome|High Intensity|Bilateral movements coupled with neuromuscular electrical stimulation. Four times per week for two weeks.
494712|NCT00369668|O3|Outcome|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation
494713|NCT00369668|O2|Outcome|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
494714|NCT00369668|O1|Outcome|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
494715|NCT00369668|E3|Reported Event|Control|Bilateral training moving both arms coupled with sham neuromuscular electrical stimulation.
494716|NCT00369668|E2|Reported Event|Low Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; two 90-minute sessions/week for 2 weeks.
494717|NCT00369668|E1|Reported Event|High Intensity|Bilateral training moving both arms coupled with neuromuscular electrical stimulation; four 90-minute sessions/week for 2 weeks.
494718|NCT00369655|B1|Baseline|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494719|NCT00369655|P1|Participant Flow|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494720|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494721|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494722|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494723|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494724|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494725|NCT00369655|O1|Outcome|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494726|NCT00369655|E1|Reported Event|Treatment (Ziv-afibercept)|Patients receive VEGF Trap IV over 1 hour on day 1. Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity.
494727|NCT00369590|B3|Baseline|Total|Total of all reporting groups
494728|NCT00369590|B2|Baseline|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494729|NCT00369590|B1|Baseline|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494730|NCT00369590|P2|Participant Flow|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494731|NCT00369590|P1|Participant Flow|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494732|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494733|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494734|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494735|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494736|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494737|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494738|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494739|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494740|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494741|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494742|NCT00369590|O2|Outcome|Arm 2 - Glioblastoma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494743|NCT00369590|O1|Outcome|Arm I - Anaplastic Glioma|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494744|NCT00369590|E1|Reported Event|All Study Patients|"Patients receive VEGF Trap (ziv-aflibercept) IV over 1 hour on day 1. Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity.~Other: pharmacological study; laboratory biomarker analysis.~ziv-aflibercept: Given IV~pharmacological study: correlative studies~laboratory biomarker analysis: correlative studies"
494745|NCT00369564|B3|Baseline|Total|Total of all reporting groups
494746|NCT00369564|B2|Baseline|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494747|NCT00369564|B1|Baseline|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494851|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494748|NCT00369564|P2|Participant Flow|Arm II Placebo|"Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Placebo capsules are identical in appearance to the active oral glutamic acid capsules but instead each capsule contains 324 mg of microcrystalline cellulose as a filler, 3 mg of magnesium stearate as a lubricant and 3 mg silicone dioxide as a drying agent for a total fill weight of 330 mg. The manufacturer has certified that the placebo contains no active agent.~Patients with a body surface area (BSA) less than 1.0 m^2 will receive a 1 capsule of placebo 3 times daily (total 3 capsules daily). Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a 2 placebo capsules 3 times daily (total 6 capsules daily). ."
494749|NCT00369564|P1|Participant Flow|Arm I Glutamic Acid|Patients receive oral l-glutamic acid hydrocloride 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1). Patients with a body surface area (BSA) less than 1.0 m^2 will receive a total of 750 mg/day of oral glutamic acid . Patients with a body surface area (BSA) greater or equal to1.0 m^2 will receive a total of 1500 mg/day of oral glutamic acid .
494750|NCT00369564|O2|Outcome|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494751|NCT00369564|O1|Outcome|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494752|NCT00369564|E2|Reported Event|Arm II Placebo|Patients receive oral placebo 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494753|NCT00369564|E1|Reported Event|Arm I Glutamic Acid|Patients receive oral glutamic acid 3 times daily beginning prior to the first dose of vincristine and continuing through week 5 (stratum 2) or week 10 (stratum 1).
494754|NCT00369512|B1|Baseline|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494755|NCT00369512|P1|Participant Flow|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494756|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494757|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494758|NCT00369512|O1|Outcome|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494759|NCT00369512|E1|Reported Event|Erlotinib|Erlotinib therapy for 2 weeks (150 mg po qd)(for those who are enrolled before surgery is done), surgery/biopsy up to 8 weeks recovery, radiation/Erlotinib therapy for 6 weeks (150mg po qd).
494760|NCT00369486|B6|Baseline|Total|Total of all reporting groups
494761|NCT00369486|B5|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494762|NCT00369486|B4|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494763|NCT00369486|B3|Baseline|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494764|NCT00369486|B2|Baseline|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494765|NCT00369486|B1|Baseline|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494766|NCT00369486|P5|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494767|NCT00369486|P4|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494768|NCT00369486|P3|Participant Flow|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494769|NCT00369486|P2|Participant Flow|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494770|NCT00369486|P1|Participant Flow|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494771|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494772|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494773|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494774|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494775|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494776|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494777|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494778|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494779|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494780|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494781|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494782|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494783|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494784|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494785|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494786|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494787|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494788|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494789|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494790|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494791|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494792|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494793|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494794|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494795|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494796|NCT00369486|O5|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494797|NCT00369486|O4|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494798|NCT00369486|O3|Outcome|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494799|NCT00369486|O2|Outcome|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494800|NCT00369486|O1|Outcome|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494801|NCT00369486|E5|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone + Laser|Anterior peribulbar injection of 20 mg triamcinolone followed by focal photocoagulation after one month
494802|NCT00369486|E4|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone + Laser|Posterior peribulbar injection of 40 mg triamcinolone followed by focal photocoagulation after one month
494803|NCT00369486|E3|Reported Event|Anterior Peribulbar Injection of 20 mg Triamcinolone|Anterior peribulbar injection of 20 mg triamcinolone
494804|NCT00369486|E2|Reported Event|Posterior Peribulbar Injection of 40 mg Triamcinolone|Posterior peribulbar injection of 40 mg triamcinolone (Kenalog)
494805|NCT00369486|E1|Reported Event|Focal Laser Photocoagulation|Modified Early Treatment diabetic retinopathy Study technique (m-ETDRS, Laser burns-50 microns, gray intensity Multiple settings (all completed in single setting).
494806|NCT00369382|B3|Baseline|Total|Total of all reporting groups
494807|NCT00369382|B2|Baseline|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494808|NCT00369382|B1|Baseline|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494809|NCT00369382|P2|Participant Flow|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494810|NCT00369382|P1|Participant Flow|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494811|NCT00369382|O1|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494852|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
494853|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494812|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494813|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494814|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494815|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494816|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494817|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494818|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494819|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494820|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494821|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494822|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494823|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494824|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494825|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494826|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494827|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494828|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494829|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494854|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
495153|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
494830|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494831|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494832|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494833|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494834|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494835|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494836|NCT00369382|O2|Outcome|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494837|NCT00369382|O1|Outcome|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494838|NCT00369382|E2|Reported Event|Sirolimus (SRL)|Conversion from CNI therapy to Sirolimus: Sirolimus initiated with oral tablets administered once daily (1 to 5 milligrams per day) to achieve target trough of 8-15 nanograms per milliliter (ng/mL). Protocol was later amended to allow target troughs of 7-15 ng/mL for duration of study. CNI discontinued within 8 weeks post randomization.
494839|NCT00369382|E1|Reported Event|Cyclosporine or Tacrolimus|Continuation of Calcineurin inhibitor (CNI) regimen; included cyclosporine (CsA) or tacrolimus (TAC) which were dosed to achieve a target trough level determined by investigator; therefore, form, dosage, and frequency were site and patient specific. CsA therapy could have been switched to TAC therapy and vice versa, as warranted by clinical circumstances.
494840|NCT00369343|B3|Baseline|Total|Total of all reporting groups
494841|NCT00369343|B2|Baseline|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494842|NCT00369343|B1|Baseline|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494843|NCT00369343|P2|Participant Flow|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494844|NCT00369343|P1|Participant Flow|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494845|NCT00369343|O3|Outcome|200 mg|DVS SR 200mg dosage was reduced to DVS SR 100mg for 7 days and then further reduced to DVS SR 50mg from days 8 to 14.
494846|NCT00369343|O2|Outcome|100 mg|DVS SR 100mg dosage was reduced to DVS SR 50mg for 7 days.
494847|NCT00369343|O1|Outcome|0 mg|Placebo
494848|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
494849|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494850|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
495154|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
494855|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494856|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
494857|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494858|NCT00369343|O2|Outcome|Placebo / DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
494859|NCT00369343|O1|Outcome|DVS SR / DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494860|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494861|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494862|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494863|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494864|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494865|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494866|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494867|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494868|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494869|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494870|NCT00369343|O2|Outcome|Placebo|Double-blind Phase Placebo administered daily for 8 weeks Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg/day for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
495155|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
494871|NCT00369343|O1|Outcome|Desvenlafaxine Succinate Sustained-Release (DVS SR)|Double-blind Phase Days 1 to 7: 50 mg/day (one 50 mg tablet) Days 8 to 14: 100 mg/day (one 100 mg tables) Days 15 to 56: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Open-label Phase Days 57-63: 100 mg/day (one 100 mg tablet) Days 64-238: At the discretion of the investigator, patients assigned 100 mg/day (one 100 mg tablet) or 200 mg/day (two 100 mg tablets) Taper Phase Day 239 or at discontinuation: If patient taking 200 mg/day, then decreased to 100 mg for 7 days, and then decreased to 50 mg/day for 7 days. Patients taking 100 mg/day decreased to 50 mg/day for 7 days.
494872|NCT00369343|E4|Reported Event|Open-label Placebo/DVS SR|Patients were in the Placebo arm during the double-blind phase and the DVS SR arm during the open-label phase.
494873|NCT00369343|E3|Reported Event|Open-label DVS SR/ DVS SR|Patients were in the DVS SR arm during both the double-blind and open-label phase.
494874|NCT00369343|E2|Reported Event|Double-blind Placebo|Placebo administered daily for 8 weeks
494875|NCT00369343|E1|Reported Event|Double-blind DVS SR|"Days 1 to 7:~Patients will be instructed to take 1-50mg tablet per day~Days 8 to 14:~Patients will be instructed to take 1-100mg tablet per day~Days 15 to 56:~At the discretion of the investigator, patients may be assigned to 100mg or 200mg tablets per day"
494876|NCT00369317|B1|Baseline|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
494877|NCT00369317|P1|Participant Flow|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
494878|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
494879|NCT00369317|O1|Outcome|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
494880|NCT00369317|E1|Reported Event|Treatment (Combination Chemotherapy)|"INDUCTION THERAPY COURSE I: Patients receive cytarabine IT on day 1 and cytarabine IV continuously over 96 hours, daunorubicin hydrochloride IV continuously, and oral thioguanine BID on days 1-4. COURSE II: Patients receive high-dose cytarabine IV over 3 hours BID on days 1, 2, 8, and 9 and asparaginase (IM) on days 2 and 9.~COURSE III: Patients receive treatment as in course I. COURSE IV: Patients receive cytarabine IV, daunorubicin hydrochloride IV, and oral thioguanine as in course I~INTENSIFICATION THERAPY: Patients receive cytarabine IV continuously over 168 hours on days 1-7 and etoposide IV over 1 hour on days 1-3. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity.~asparaginase: Given IM~daunorubicin hydrochloride: Given IV~cytarabine: Given IV or IT~thioguanine: Given orally~etoposide: Given IV~laboratory biomarker analysis: Correlative studies"
494881|NCT00369278|B3|Baseline|Total|Total of all reporting groups
494882|NCT00369278|B2|Baseline|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494883|NCT00369278|B1|Baseline|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494884|NCT00369278|P2|Participant Flow|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494885|NCT00369278|P1|Participant Flow|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
495156|NCT00368459|E2|Reported Event|Placebo|identical appearing oral placebo
494886|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494887|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494888|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494889|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494890|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494891|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494892|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494893|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494894|NCT00369278|O2|Outcome|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study(month 6): 1440 mg/day (2 x 720 mg)
494895|NCT00369278|O1|Outcome|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494896|NCT00369278|E2|Reported Event|Standard Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1 - End of Study (month 6): 1440 mg/day (2 x 720 mg)
494897|NCT00369278|E1|Reported Event|Intensified Mycophenolate Sodium|Enteric-coated mycophenolate sodium was given according to the following dosing regimen: Day 1-14: 2880 mg/day (2 x 1440 mg), then day 15-42: 2160 mg/day (2 x 1080 mg), then day 43-End of study (month 6): 1440 mg/day (2 x 720 mg)
494898|NCT00369265|B3|Baseline|Total|Total of all reporting groups
494899|NCT00369265|B2|Baseline|Lansoprazole|Lansoprazole 30 mg twice daily
494900|NCT00369265|B1|Baseline|Sugar Pill|Placebo for Lansoprazole twice daily
494901|NCT00369265|P2|Participant Flow|Lansoprazole|Lansoprazole 30 mg twice daily
494902|NCT00369265|P1|Participant Flow|Sugar Pill|Placebo for Lansoprazole twice daily
494903|NCT00369265|O2|Outcome|Lansoprazole|Lansoprazole 30 mg twice daily
494904|NCT00369265|O1|Outcome|Sugar Pill|Placebo for Lansoprazole twice daily
494905|NCT00369265|E2|Reported Event|Lansoprazole|Lansoprazole 30 mg twice daily
494906|NCT00369265|E1|Reported Event|Sugar Pill|Placebo for Lansoprazole twice daily
494907|NCT00369226|B3|Baseline|Total|Total of all reporting groups
494908|NCT00369226|B2|Baseline|Phase II|
494909|NCT00369226|B1|Baseline|Phase I|
494910|NCT00369226|P2|Participant Flow|Phase II (45 Days)|
494911|NCT00369226|P1|Participant Flow|Phase I (45 Days)|Bortezomib plus tacrolimus and methotrexate after mismatched allogeneic non-myeloablative hematopoietic stem cell transplantation (HSCT).
494912|NCT00369226|O2|Outcome|Overall Survival (OS)|This reports on all treated patients across both phase I and phase II (n=45)
494913|NCT00369226|O1|Outcome|Progression-free Survival (PFS)|This reports on all treated patients across both phase I and phase II (n=45)
494914|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
494915|NCT00369226|O1|Outcome|Phase I and Phase II|Engraftment is determined for all treated patients across both phase I and phase II (n=45) who are evaluable for this endpoint (n=35)
494916|NCT00369226|O1|Outcome|Phase I and Phase II|This reports on all treated patients across both phase I and phase II (n=45)
494917|NCT00369226|O1|Outcome|Combined Phase I Plus Phase II|This reports on the total phase I plus phase II patients who were evaluable for chimerism endpoint (37 of the 45 patients).
494918|NCT00369226|O1|Outcome|Phase I|
494919|NCT00369226|E1|Reported Event|Phase I-II|
494920|NCT00369161|B3|Baseline|Total|Total of all reporting groups
494921|NCT00369161|B2|Baseline|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494941|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
494942|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
494943|NCT00368992|E1|Reported Event|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
494944|NCT00368979|B3|Baseline|Total|Total of all reporting groups
494945|NCT00368979|B2|Baseline|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494946|NCT00368979|B1|Baseline|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494922|NCT00369161|B1|Baseline|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494923|NCT00369161|P2|Participant Flow|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494924|NCT00369161|P1|Participant Flow|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494925|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494926|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494927|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494928|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494947|NCT00368979|P2|Participant Flow|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494948|NCT00368979|P1|Participant Flow|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494949|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494950|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494929|NCT00369161|O2|Outcome|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494930|NCT00369161|O1|Outcome|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494931|NCT00369161|E2|Reported Event|Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 4 and 7 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494932|NCT00369161|E1|Reported Event|Very Low Dose Tacrolimus|The first dose of everolimus was to be administered not later than 24 hours after transplantation with a starting dose of 1.5 mg bis in diem/twice a day (b.i.d.) thereafter adjusted to maintain the trough blood levels between 3 and 8 ng/ml. Tacrolimus was to be initiated within 24 hours after reperfusion of the graft with a starting dose of 0.1 mg/kg/day thereafter adjusted to maintain the trough blood levels between 4 and 7 ng/ml. Up to months three all patients received the same treatment and after three months patients in this arm received tacrolimus to reach a trough blood level between 1.5 and 3 ng/ml. All patients received two doses of 20 mg basiliximab, administered as an intravenous bolus injection. The first dose was given on the day of transplantation, with the second dose being administered on the fourth day post-transplant. Intravenous (i.v.) prednisone (or equivalent) was given pre- or intra-operatively according to center practice.
494933|NCT00369122|B1|Baseline|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
494934|NCT00369122|P1|Participant Flow|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
494935|NCT00369122|O1|Outcome|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35."
494936|NCT00369122|E1|Reported Event|Treatment (Radiation Therapy, Bevacizumab, Cisplatin)|"Patients undergo pelvic EBRT once daily, 5 days a week, for 5 weeks for a total of 45 Gy.~Some patients also undergo low-dose rate brachytherapy twice, 1-3 weeks apart, beginning >= 4 weeks after initiating EBRT or high-dose rate brachytherapy 5 times, >= 48 hours apart, beginning >= 2 weeks after initiating EBRT. EBRT and chemotherapy are halted on the day of high-dose rate brachytherapy. Patients receive bevacizumab IV over 30-90 minutes on days 1, 15, and 29 and cisplatin IV over 60 minutes on days 1, 8, 15, 22, 29, and 35.~Data is reported for all patients who received study treatment, which is 59 patients."
494937|NCT00368992|B1|Baseline|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
494938|NCT00368992|P1|Participant Flow|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|"This was a single arm Phase II trial. Patients were treated with induction therapy cetuximab IV over 1-2 hours on days 1, 8, and 15 and paclitaxel IV over 3 hours, carboplatin IV over 30 minutes, and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~Patients who were not removed due to unacceptable toxicity or disease progression were then treated with maintenance therapy cetuximab IV over 1 hour on days 1, 8, and 15 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity."
494939|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|
494940|NCT00368992|O1|Outcome|Carboplatin, Paclitaxel, Cetuximab, and Bevacizumab|This was a single arm Phase II trial. Patients were treated until progression.
494951|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494952|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494953|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494954|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494955|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494956|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494957|NCT00368979|O2|Outcome|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494958|NCT00368979|O1|Outcome|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494959|NCT00368979|E2|Reported Event|Dutasteride|Subjects who took dutasteride, study medication of 0.5 mg capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494960|NCT00368979|E1|Reported Event|Placebo|Subjects who took no study medication capsule once daily for 52 weeks followed by up to 16 weeks of post-dosing assessments.
494961|NCT00368966|B3|Baseline|Total|Total of all reporting groups
494962|NCT00368966|B2|Baseline|7vPnC|Subjects received 1 dose (0.5 mL) of 7vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 7vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 7vPnC and Infanrix-IPV+Hib, Meningitec.
494963|NCT00368966|B1|Baseline|13vPnC|Subjects received 1 dose (0.5 mL) of 13vPnC together with 1 dose (0.5 mL) of each of the following concomitant vaccines: Infanrix hexa and Meningitec at 2 and 4 months. At 6 months subjects received 13vPnC and Infanrix hexa. At 12 months subjects received MMR II. At 15 months subjects received 13vPnC and Infanrix-IPV+Hib, Meningitec.
494964|NCT00368966|P2|Participant Flow|7vPnC|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
494965|NCT00368966|P1|Participant Flow|13vPnC|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a combination vaccine diphtheria, tetanus, and pertussis (acellular) vaccine (DTPa), hepatitis B virus vaccine (HBV), inactivated poliovirus (IPV), and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) and a meningococcal C conjugate vaccine (Meningitec) at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine measles, mumps, rubella live virus (MMR II) at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with DTPa, IPV, and Hib vaccine (Infanrix-IPV+Hib) and Meningitec at 15 months.
494966|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494967|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494968|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
494969|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494970|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494971|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494972|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494973|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494974|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494975|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494976|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494977|NCT00368966|O4|Outcome|7vPnC Afte the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494978|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494979|NCT00368966|O2|Outcome|7vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494980|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494981|NCT00368966|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months.
494982|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494983|NCT00368966|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494984|NCT00368966|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494985|NCT00368966|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494986|NCT00368966|O2|Outcome|13vPnC After Infant Series Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494987|NCT00368966|O1|Outcome|13vPnC After Infant Series Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months (infant series).
494988|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494989|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494990|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494991|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
494992|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
494993|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
494994|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
494995|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
494996|NCT00368966|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494997|NCT00368966|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
494998|NCT00368966|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series).
494999|NCT00368966|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series).
495000|NCT00368966|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
495001|NCT00368966|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 4 months (infant series).
495002|NCT00368966|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
495003|NCT00368966|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 months (infant series).
495004|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
495005|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
495006|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
495007|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months(toddler dose).
495008|NCT00368966|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
495157|NCT00368459|E1|Reported Event|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495158|NCT00368316|B3|Baseline|Total|Total of all reporting groups
501887|NCT00349908|O1|Outcome|Group 1|Atherosclerosis Arm
495009|NCT00368966|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose).
495010|NCT00368966|E8|Reported Event|7vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 7vPnC toddler dose at 21 months of age.
495011|NCT00368966|E7|Reported Event|13vPnC 6-Month Follow-up|Assessment was done approximately 6 months after 13vPnC toddler dose at 21 months of age.
495012|NCT00368966|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
495013|NCT00368966|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with MMR II at 12 months. Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix-IPV+Hib and Meningitec at 15 months (toddler dose). Assessment was done approximately one month after toddler dose at 16 months of age.
495014|NCT00368966|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 6 months, assessment was done approximately one month after dose 3 at 7 months of age.
495015|NCT00368966|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 6 months (infant series), assessment was done approximately one month after dose 3 at 7 months of age.
495016|NCT00368966|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
495017|NCT00368966|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a combination vaccine Infanrix hexa and Meningitec at 2 and 4 months, assessment was done approximately one month after dose 2 at 5 months of age.
495018|NCT00368927|B3|Baseline|Total|Total of all reporting groups
495019|NCT00368927|B2|Baseline|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
495020|NCT00368927|B1|Baseline|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
495021|NCT00368927|P2|Participant Flow|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
495022|NCT00368927|P1|Participant Flow|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
495023|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
495024|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
495025|NCT00368927|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
495026|NCT00368927|O1|Outcome|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
495027|NCT00368927|E2|Reported Event|Arm B (Placebo)|Patients receive oral placebo twice daily for 6 months.
495028|NCT00368927|E1|Reported Event|Arm A (Sulindac)|Patients receive oral sulindac twice daily for 6 months.
495029|NCT00368875|B1|Baseline|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
495030|NCT00368875|P2|Participant Flow|Phase II|"Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
495031|NCT00368875|P1|Participant Flow|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
495032|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
495033|NCT00368875|O1|Outcome|Vorinostat, Paclitaxel, Bevacizumab|"Vorinostat BID on days 1-3, 8-10, and 15-17, paclitaxel IV over 1 hour on days 2, 9, and 16, bevacizumab IV over 30-90 minutes on days 2 and 16, repeat every 28 days.~vorinostat: Given orally~paclitaxel: Given IV~bevacizumab: Given IV"
495057|NCT00368745|P1|Participant Flow|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
503108|NCT00344032|B3|Baseline|Total|Total of all reporting groups
495034|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
495035|NCT00368875|O1|Outcome|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
495036|NCT00368875|O1|Outcome|Phase I|"Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy."
495037|NCT00368875|E1|Reported Event|Phase I + Phase II|"Phase I: Vorinostat dose (200 or 300 mg BID) was assigned at the time of registration. Vorinostat was administered orally twice daily on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose. Vorinostat dose escalation was carried out in the standard 3 + 3 phase I trial design based upon toxicity observed during the first cycle of therapy.~Phase II: Vorinostat was administered orally twice daily at the recommended phase II dose of 300 mg on days 1–3, 8–10, and 15–17 of each 28-day cycle.~All patients also received paclitaxel at 90 mg/m2 as 1-hour infusion on days 2, 9, and 16 of every 28-day cycle. Bevacizumab was administered on day 2 and day 16 of the 28 day cycle at 10 mg/kg dose."
495038|NCT00368849|B1|Baseline|All Participants|Age, sex, and region of enrollment were available for all 20 participants.
495039|NCT00368849|P2|Participant Flow|Placebo (4 Weeks) Then Atomoxetine (4 Weeks)|Participants received twice a day matching placebo for four weeks. After a two week washout, they then received 40 milligram twice a day atomoxetine for four weeks.
495040|NCT00368849|P1|Participant Flow|Atomoxetine (4 Weeks) Then Placebo (4 Weeks)|Participants received 40 milligram twice a day atomoxetine for four weeks. After a two week wash out, they then received twice a day matching placebo for four weeks.
495041|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
495042|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
495043|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
495044|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
495045|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
495046|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
495047|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
495048|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
495049|NCT00368849|O2|Outcome|Placebo|Individuals in this arm received twice a day matching placebo.
495050|NCT00368849|O1|Outcome|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine
495051|NCT00368849|E2|Reported Event|Matching Placebo|Individuals in this arm received twice a day matching placebo.
495052|NCT00368849|E1|Reported Event|Atomoxetine|Individuals in this arm received 40 milligram twice a day atomoxetine.
495053|NCT00368745|B3|Baseline|Total|Total of all reporting groups
495054|NCT00368745|B2|Baseline|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495055|NCT00368745|B1|Baseline|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495056|NCT00368745|P2|Participant Flow|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495058|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495059|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495060|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495061|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495062|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495063|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495064|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495065|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495066|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495067|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495068|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495106|NCT00368550|E2|Reported Event|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495069|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495070|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495071|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495072|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495073|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495074|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495075|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495076|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495077|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495078|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495079|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495150|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495151|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495080|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495081|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495082|NCT00368745|O2|Outcome|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495083|NCT00368745|O1|Outcome|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495084|NCT00368745|E2|Reported Event|Placebo 75 mg to 300 mg PO BID|Placebo treatment following randomization to double-blind treatment: Baseline to Week 1: placebo 75 mg PO BID (150 mg/day); Week 2: placebo 150 mg PO BID (300 mg/day); Week 3 to Week 6 placebo PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with placebo at the same dose as during the double-blind taper.
495085|NCT00368745|E1|Reported Event|Pregabalin 75 mg to 300 mg PO BID|Pregabalin treatment following randomization to double-blind treatment: Baseline to Week 1: Pregabalin 75 mg PO BID (150 mg/day); Week 2: Pregabalin 150 mg PO BID (300 mg/day); Week 3 to Week 6 Pregabalin PO dosing ranged from 150 to 600 mg/day, given BID; during double-blind the alprazolam dose was tapered with a 25% reduction each week from baseline up to 6 weeks depending on the starting dose of alprazolam and toleration of dose reduction. Subjects successfully discontinued from alprazolam, continued for an additional 6 weeks of double-blind treatment with pregabalin at the same dose as during the double-blind taper.
495086|NCT00368641|B3|Baseline|Total|Total of all reporting groups
495087|NCT00368641|B2|Baseline|Standard Therapy|Standard therapy for CHF
495088|NCT00368641|B1|Baseline|Intervention Group|Addition of peritoneal ultrafiltration
495089|NCT00368641|P2|Participant Flow|Standard Therapy|Standard therapy for CHF
495090|NCT00368641|P1|Participant Flow|Intervention Group|Addition of peritoneal ultrafiltration
495091|NCT00368641|O2|Outcome|Standard Therapy|Standard therapy for CHF
495092|NCT00368641|O1|Outcome|Intervention Group|Addition of peritoneal ultrafiltration
495093|NCT00368641|E2|Reported Event|Standard Therapy|Standard therapy for CHF
495094|NCT00368641|E1|Reported Event|Intervention Group|Addition of peritoneal ultrafiltration
495095|NCT00368550|B3|Baseline|Total|Total of all reporting groups
495096|NCT00368550|B2|Baseline|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495097|NCT00368550|B1|Baseline|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495098|NCT00368550|P2|Participant Flow|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495099|NCT00368550|P1|Participant Flow|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495100|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495101|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495102|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495103|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495104|NCT00368550|O2|Outcome|Placebo|Placebo plus coping skills therapy. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495105|NCT00368550|O1|Outcome|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495152|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495107|NCT00368550|E1|Reported Event|Sertraline|Sertraline plus coping skills therapy. Medication to a maximum of 200 mg/day orally in two doses. Coping skills therapy, aimed at improving patients’ ability to change their drinking behavior, was provided at each visit.
495108|NCT00368537|B3|Baseline|Total|Total of all reporting groups
495109|NCT00368537|B2|Baseline|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495110|NCT00368537|B1|Baseline|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495111|NCT00368537|P2|Participant Flow|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495112|NCT00368537|P1|Participant Flow|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495113|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495114|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495115|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495116|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495117|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495118|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495119|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495120|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495121|NCT00368537|O2|Outcome|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495122|NCT00368537|O1|Outcome|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495123|NCT00368537|E2|Reported Event|Ampicillin-Sulbactam or Amoxicillin-Clavulanate|Ampicillin-sulbactam 1.5 g (1 g ampicillin plus 0.5 g sulbactam) to 3 g (2 g ampicillin plus 1 g sulbactam) IV every 6 hours or amoxicillin-clavulanate 1.2 g (1000 mg amoxicillin plus 200 mg clavulanate) IV every 6 to 8 hours.
495124|NCT00368537|E1|Reported Event|Tigecycline|Tigecycline every 12 hours IV (an initial dose of 100 mg followed by 50 mg every 12 hours)
495125|NCT00368472|B1|Baseline|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495126|NCT00368472|P1|Participant Flow|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495127|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495128|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495129|NCT00368472|O1|Outcome|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495130|NCT00368472|E1|Reported Event|Perampanel|Participants previously receiving perampanel/placebo in the double-blind study, were titrated to receive perampanel 2 mg to 12 mg, once daily in the Open-Label Extension (OLE) study.
495131|NCT00368459|B3|Baseline|Total|Total of all reporting groups
495132|NCT00368459|B2|Baseline|Placebo|identical appearing oral placebo
495133|NCT00368459|B1|Baseline|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495134|NCT00368459|P2|Participant Flow|Placebo|identical appearing oral placebo
495135|NCT00368459|P1|Participant Flow|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495136|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495137|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495138|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495139|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495140|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495141|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495142|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495143|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495144|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495145|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495146|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495147|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495148|NCT00368459|O2|Outcome|Placebo|identical appearing oral placebo
495149|NCT00368459|O1|Outcome|Raloxifene|"oral raloxifene 120 mg once daily~raloxifene"
495159|NCT00368316|B2|Baseline|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495160|NCT00368316|B1|Baseline|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495161|NCT00368316|P2|Participant Flow|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495162|NCT00368316|P1|Participant Flow|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495163|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495164|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495165|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495166|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495167|NCT00368316|O2|Outcome|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495168|NCT00368316|O1|Outcome|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495169|NCT00368316|E2|Reported Event|S. Flexneri 2a Conjugate Vaccine|Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495170|NCT00368316|E1|Reported Event|S. Sonnei Conjugate Vaccine|Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
495171|NCT00368290|B3|Baseline|Total|Total of all reporting groups
495172|NCT00368290|B2|Baseline|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495173|NCT00368290|B1|Baseline|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495174|NCT00368290|P2|Participant Flow|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495175|NCT00368290|P1|Participant Flow|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495176|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495177|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495178|NCT00368290|O2|Outcome|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495179|NCT00368290|O1|Outcome|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495180|NCT00368290|E2|Reported Event|Placebo|"placebo plus CBT~placebo: placebo pills for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495181|NCT00368290|E1|Reported Event|Modafinil|"modafinil plus CBT~Modafinil: 300mg a day for 8 weeks~Cognitive Behavioral Therapy (CBT): Weekly cognitive behavioral therapy sessions for a period of 8 weeks."
495182|NCT00368277|B3|Baseline|Total|Total of all reporting groups
495183|NCT00368277|B2|Baseline|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495184|NCT00368277|B1|Baseline|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495185|NCT00368277|P2|Participant Flow|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495186|NCT00368277|P1|Participant Flow|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495187|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495224|NCT00368108|B2|Baseline|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495188|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495189|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495190|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495191|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495192|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495193|NCT00368277|O2|Outcome|Ramipril Based Treatment Regimen|Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
495194|NCT00368277|O1|Outcome|Aliskiren Based Treatment Regimen|Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
495195|NCT00368277|E2|Reported Event|Ramipril|Ramipril based regimen
495196|NCT00368277|E1|Reported Event|Aliskiren|Aliskiren based regimen
495197|NCT00368251|B4|Baseline|Total Title|
495198|NCT00368251|B3|Baseline|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495199|NCT00368251|B2|Baseline|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495200|NCT00368251|B1|Baseline|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495201|NCT00368251|P3|Participant Flow|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495202|NCT00368251|P2|Participant Flow|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495203|NCT00368251|P1|Participant Flow|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495204|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495205|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495206|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495207|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495208|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495209|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495210|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495211|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495212|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495213|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495214|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495215|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495216|NCT00368251|O3|Outcome|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495217|NCT00368251|O2|Outcome|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495218|NCT00368251|O1|Outcome|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495219|NCT00368251|E3|Reported Event|Brivaracetam 150 mg/Day|Brivaracetam (BRV) 150 mg/day 75 mg twice a day (bid) using 25 mg and 50 mg tablets for 12 weeks (after 2 week Up-Titration Period)
495220|NCT00368251|E2|Reported Event|Brivaracetam 5 mg/Day|Brivaracetam (BRV) 5 mg/day 2.5 mg twice a day (bid) using 2.5 mg tablets for 12 weeks (after 2 week Up- Titration Period)
495221|NCT00368251|E1|Reported Event|Placebo|Placebo twice a day (bid), 14 weeks (2 week Up-Titration Period + 12 week Maintenance Period)
495222|NCT00368108|B4|Baseline|Total|Total of all reporting groups
495223|NCT00368108|B3|Baseline|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495268|NCT00367991|O2|Outcome|rHuEPO|recombinant human erythropoietin
495269|NCT00367991|O1|Outcome|Placebo|normal saline
495225|NCT00368108|B1|Baseline|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495226|NCT00368108|P3|Participant Flow|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495227|NCT00368108|P2|Participant Flow|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495228|NCT00368108|P1|Participant Flow|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495229|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495230|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495231|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495232|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495233|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495234|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495235|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495236|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495237|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495238|NCT00368108|O3|Outcome|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495239|NCT00368108|O2|Outcome|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495240|NCT00368108|O1|Outcome|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495241|NCT00368108|E3|Reported Event|Perampanel 4mg|The Perampanel 4mg group first were subjected to a 4 week titration period, followed by a maintenance period for the remaining weeks. Subjects taking perampanel 4mg had a titration period of 4 weeks, starting at 2mg per day adding 1mg of perampanel every two weeks up to 4mg. The dosages were to be taken orally once every day in the evening.
495242|NCT00368108|E2|Reported Event|Perampanel 2mg|The Perampanel 2mg dosage was fixed for the entire double-blind study. Subjects taking perampanel 2mg were to take the dose orally once every day in the evening.
495243|NCT00368108|E1|Reported Event|Placebo|The placebo dosage was a fixed dosage for the entire double-blind study. Subjects receiving the placebo were to take one dose orally once every day in the evening.
495244|NCT00368069|B3|Baseline|Total|Total of all reporting groups
495245|NCT00368069|B2|Baseline|Placebo|placebo
495246|NCT00368069|B1|Baseline|Keppra®|Keppra® extended release formulation (XR)
495247|NCT00368069|P2|Participant Flow|Placebo|placebo
495248|NCT00368069|P1|Participant Flow|Keppra®|Keppra® extended release formulation (XR)
495249|NCT00368069|O2|Outcome|Placebo|placebo
495250|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495251|NCT00368069|O2|Outcome|Placebo|placebo
495252|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495253|NCT00368069|O2|Outcome|Placebo|placebo
495254|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495255|NCT00368069|O2|Outcome|Placebo|placebo
495256|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495257|NCT00368069|O2|Outcome|Placebo|placebo
495258|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495259|NCT00368069|O2|Outcome|Placebo|placebo
495260|NCT00368069|O1|Outcome|Keppra®|Keppra® extended release formulation (XR)
495261|NCT00368069|E2|Reported Event|Placebo|placebo
495262|NCT00368069|E1|Reported Event|Keppra®|Keppra® extended release formulation (XR)
495263|NCT00367991|B3|Baseline|Total|Total of all reporting groups
495264|NCT00367991|B2|Baseline|Placebo|Normal saline volume to match active treatment IV daily for 3 days
495265|NCT00367991|B1|Baseline|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
495266|NCT00367991|P2|Participant Flow|Placebo|Normal saline volume to match active treatment IV daily for 3 days
495267|NCT00367991|P1|Participant Flow|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
495270|NCT00367991|E2|Reported Event|Placebo|Normal saline volume to match active treatment IV daily for 3 days
495271|NCT00367991|E1|Reported Event|rHuEPO|recombinant human erythropoietin 200 U/kg IV daily for 3 days
495272|NCT00366678|B3|Baseline|Total|Total of all reporting groups
495273|NCT00366678|B2|Baseline|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495274|NCT00366678|B1|Baseline|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495275|NCT00366678|P3|Participant Flow|7vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC)coadministered with Pentavac at 12 months of age (toddler dose).
495276|NCT00366678|P2|Participant Flow|7vPnC/7vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495277|NCT00366678|P1|Participant Flow|13vPnC/13vPnC Vaccine|Participants received one single 0.5 milliliter (mL) dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with a vaccine containing diphtheria, tetanus, 2-component pertussis (DTaP), inactivated poliovirus (IPV), and hemophilus influenza type b vaccines (Hib) (Pentavac) at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495278|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
495279|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
495280|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495281|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495282|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
495283|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
495284|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
495285|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
495286|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
495287|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
495288|NCT00366678|O9|Outcome|7vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495289|NCT00366678|O8|Outcome|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495290|NCT00366678|O7|Outcome|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495291|NCT00366678|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
495292|NCT00366678|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 4 months of age (infant series).
495293|NCT00366678|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
495294|NCT00366678|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 3 months of age (infant series).
495295|NCT00366678|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
495296|NCT00366678|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2 months of age (infant series).
495297|NCT00366678|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
495298|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495299|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495300|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495823|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495301|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495302|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495303|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495304|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495305|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495306|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495307|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495308|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495309|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495310|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495311|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose).
495312|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
495313|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series).
495314|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
495315|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, 4, and 12 months of age.
495316|NCT00366678|O2|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
495317|NCT00366678|O1|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495318|NCT00366678|O6|Outcome|7vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose), assessment made at 13 months of age.
495319|NCT00366678|O5|Outcome|7vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series). Participants recieved one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 12 months of age (toddler dose).
495320|NCT00366678|O4|Outcome|7vPnC/7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
495321|NCT00366678|O3|Outcome|7vPnC/7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495322|NCT00366678|O2|Outcome|13vPnC/13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose), assessment made at 13 months of age.
495323|NCT00366678|O1|Outcome|13vPnC/13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495324|NCT00366678|O3|Outcome|7vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months. One single 0.5 mL dose of 13vPnC was coadministered with Pentavac at 12 months of age.
495325|NCT00366678|O2|Outcome|7vPnC Infant Series / 7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495326|NCT00366678|O1|Outcome|13vPnC Infant Series / 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495327|NCT00366678|O4|Outcome|7vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495328|NCT00366678|O3|Outcome|13vPnC After the Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495378|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495329|NCT00366678|O2|Outcome|7vPnC After the Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495330|NCT00366678|O1|Outcome|13vPnC After the Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler dose).
495331|NCT00366678|E10|Reported Event|7vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and at 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
495332|NCT00366678|E9|Reported Event|7vPnC / 7vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 7vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
495333|NCT00366678|E8|Reported Event|13vPnC / 13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13vPnC coadministered with Pentavac at 2, 3, and 4 months of age (infant series) and 12 months of age (toddler). Adverse events were collected for approximately six months after last visit.
495334|NCT00366678|E7|Reported Event|7vPnC/ 13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
495335|NCT00366678|E6|Reported Event|7vPnC/7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
495336|NCT00366678|E5|Reported Event|13vPnC/13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 12 months of age (toddler dose). Adverse events were collected for approximately one month after toddler dose.
495337|NCT00366678|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
495338|NCT00366678|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from approximately one month after dose 3 to toddler dose.
495339|NCT00366678|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
495340|NCT00366678|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with a vaccine containing Pentavac at 2, 3, and 4 months of age (infant series). Adverse events were collected from dose 1 to approximately one month after dose 3.
495341|NCT00366626|B3|Baseline|Total|Total of all reporting groups
495342|NCT00366626|B2|Baseline|Placebo|
495343|NCT00366626|B1|Baseline|Naltrexone|
495344|NCT00366626|P2|Participant Flow|Placebo|
495345|NCT00366626|P1|Participant Flow|Naltrexone|
495346|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
495347|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
495348|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
495349|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
495350|NCT00366626|O4|Outcome|Placebo (asp40)|Subjects with asp40 OPRM1 SNP who got Placebo during he study
495351|NCT00366626|O3|Outcome|Placebo (asn40asn )|Subjects with asn40asn OPRM1 SNP who got Placebo during he study
495352|NCT00366626|O2|Outcome|Naltrexone (asp40)|Subjects with asp40 OPRM1 SNP who got Naltrexone during he study
495353|NCT00366626|O1|Outcome|Naltrexone (asn40asn)|Subjects with asn40asn OPRM1 SNP who got Naltrexone during he study
495354|NCT00366626|E2|Reported Event|Placebo|
495355|NCT00366626|E1|Reported Event|Naltrexone|
495356|NCT00367835|B3|Baseline|Total|Total of all reporting groups
495357|NCT00367835|B2|Baseline|Placebo|
495358|NCT00367835|B1|Baseline|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495359|NCT00367835|P2|Participant Flow|Placebo|
495360|NCT00367835|P1|Participant Flow|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495361|NCT00367835|O2|Outcome|Placebo|
495362|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495363|NCT00367835|O2|Outcome|Placebo|
495364|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495365|NCT00367835|O2|Outcome|Placebo|
495366|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495367|NCT00367835|O2|Outcome|Placebo|
495368|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495369|NCT00367835|O2|Outcome|Placebo|
495370|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495371|NCT00367835|O2|Outcome|Placebo|
495372|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495373|NCT00367835|O2|Outcome|Placebo|
495374|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495375|NCT00367835|O2|Outcome|Placebo|
495376|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495377|NCT00367835|O2|Outcome|Placebo|
495379|NCT00367835|O2|Outcome|Placebo|
495380|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495381|NCT00367835|O2|Outcome|Placebo|
495382|NCT00367835|O1|Outcome|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495383|NCT00367835|E2|Reported Event|Placebo|
495384|NCT00367835|E1|Reported Event|SPD503|Subjects will receive either 1, 2, 3, or 4 mg/day oral doses of SPD503 (Guanfacine hydrochloride)
495385|NCT00367770|B1|Baseline|Overall Study Arm|
495386|NCT00367770|P1|Participant Flow|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
495387|NCT00367770|O1|Outcome|Overall Study Arm|
495388|NCT00367770|O1|Outcome|Overall Study Arm|
495389|NCT00367770|O1|Outcome|Overall Study Arm|
495390|NCT00367770|E1|Reported Event|Tracleer|The starting dose for all patients will be 62.5 mg b.i.d. At the Week 4 visit, patients who were started on 62.5 mg b.i.d. will be uptitrated to 125 mg b.i.d. if the 62.5 mg b.i.d. dose was well-tolerated.
495391|NCT00367744|B3|Baseline|Total|Total of all reporting groups
495392|NCT00367744|B2|Baseline|Placebo|Placebo arm
495393|NCT00367744|B1|Baseline|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then the dose increased to 4mg twice daily for the remainder of the study (44 weeks)
495394|NCT00367744|P2|Participant Flow|Placebo|Placebo arm for the whole duration of the study
495395|NCT00367744|P1|Participant Flow|Rosiglitazone|Rosiglitazone 4 mg daily for 4 weeks then the dose was increased to 4mg twice daily for the remainder of the study (44 weeks)
495396|NCT00367744|O2|Outcome|Placebo|Placebo arm
495397|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
495398|NCT00367744|O2|Outcome|Placebo|Placebo arm
495399|NCT00367744|O1|Outcome|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then BID for 44 weeks
495400|NCT00367744|E2|Reported Event|Placebo|Placebo arm
495401|NCT00367744|E1|Reported Event|Rosiglitazone|Rosiglitazone 4mg daily for 4 weeks then 4mg BID for 44 weeks
495402|NCT00367679|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495403|NCT00367679|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495404|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495405|NCT00367679|O1|Outcome|Overall Study Arm|
495406|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495407|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495408|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495409|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495410|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
495411|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495412|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
495413|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
495414|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
495415|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495416|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495417|NCT00367679|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495418|NCT00367679|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day for a minimum of 2 and a maximum of 6 weeks
495419|NCT00367640|B5|Baseline|Total|Total of all reporting groups
495420|NCT00367640|B4|Baseline|Placebo|Placebo tablet
495421|NCT00367640|B3|Baseline|500 IR|500 IR grass pollen allergen extract tablet
495422|NCT00367640|B2|Baseline|300 IR|300 IR grass pollen allergen extract tablet
495423|NCT00367640|B1|Baseline|100 IR|100 IR grass pollen allergen extract tablet
495424|NCT00367640|P4|Participant Flow|Placebo|Placebo tablet
495425|NCT00367640|P3|Participant Flow|500 IR|500 IR grass pollen allergen extract tablet
495426|NCT00367640|P2|Participant Flow|300 IR|300 IR grass pollen allergen extract tablet
495427|NCT00367640|P1|Participant Flow|100 IR|100 IR grass pollen allergen extract tablet
495428|NCT00367640|O4|Outcome|Placebo|Placebo tablet
495429|NCT00367640|O3|Outcome|500 IR|500 IR grass pollen allergen extract tablet
495430|NCT00367640|O2|Outcome|300 IR|300 IR grass pollen allergen extract tablet
495431|NCT00367640|O1|Outcome|100 IR|100 IR grass pollen allergen extract tablet
495432|NCT00367640|E4|Reported Event|Placebo|Placebo tablet
495433|NCT00367640|E3|Reported Event|100 IR|100 IR grass pollen allergen extract tablet
495434|NCT00367640|E2|Reported Event|300 IR|300 IR grass pollen allergen extract tablet
495435|NCT00367640|E1|Reported Event|500 IR|500 IR grass pollen allergen extract tablet
495436|NCT00367601|B1|Baseline|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
495517|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495518|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495437|NCT00367601|P1|Participant Flow|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
495438|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
495439|NCT00367601|O1|Outcome|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
495440|NCT00367601|O1|Outcome|Single Arm|Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.
495441|NCT00367601|E1|Reported Event|Single Arm Assignment|"Bevacizumab + erlotinib; if no progressive disease observed, combination or single-agent treatment will continue until unacceptable toxicity or progressive disease.~Erlotinib: Erlotinib 150 mg qd days 1-21~Bevacizumab: Bevacizumab 15 mg/kg IV, day 1"
495442|NCT00367484|B1|Baseline|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
495443|NCT00367484|P1|Participant Flow|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
495444|NCT00367484|O1|Outcome|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
495445|NCT00367484|E1|Reported Event|Rebif® (Clone 484-39)|subcutaneously administered Rebif® 44mcg three times per week
495446|NCT00367432|B1|Baseline|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495447|NCT00367432|P2|Participant Flow|Levetiracetam N01020 [NCT00160615]|N01020 [NCT00160615] was an open-label follow-up study to evaluate safety and efficacy of Levetiracetam.
495448|NCT00367432|P1|Participant Flow|Levetiracetam N01221 [NCT00280696]|N01221 [NCT00280696] was a double-blind, randomized, multicenter, placebo controlled 5 parallel groups, confirmatory trial to evaluate the efficacy and safety of Levetiracetam.
495449|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495450|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495451|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495452|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495453|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495454|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495455|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495456|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495457|NCT00367432|O1|Outcome|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495458|NCT00367432|E1|Reported Event|Levetiracetam|Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
495459|NCT00367380|B4|Baseline|Total|Total of all reporting groups
495460|NCT00367380|B3|Baseline|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
495461|NCT00367380|B2|Baseline|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
495462|NCT00367380|B1|Baseline|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
495463|NCT00367380|P3|Participant Flow|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
495464|NCT00367380|P2|Participant Flow|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
495465|NCT00367380|P1|Participant Flow|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
495466|NCT00367380|O3|Outcome|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
495467|NCT00367380|O2|Outcome|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
495468|NCT00367380|O1|Outcome|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
495865|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495469|NCT00367380|E3|Reported Event|Group 3|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 418JAL~418JAL: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 418JAL"
495470|NCT00367380|E2|Reported Event|Group 2|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 414WRR~414WRR: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 414WRR"
495471|NCT00367380|E1|Reported Event|Group 1|"6 volunteers to be challenged with the infected with +/-3 mosquito bites from batch 413ABM~413ABM: +/- 3 bites of Anopheles albimanus mosquitoes infected through membrane feeding with blood of the P. vivax infected volunteers 413ABM"
495472|NCT00367341|B3|Baseline|Total|Total of all reporting groups
495473|NCT00367341|B2|Baseline|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
495474|NCT00367341|B1|Baseline|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
495475|NCT00367341|P2|Participant Flow|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
495476|NCT00367341|P1|Participant Flow|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
495477|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
495478|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
495479|NCT00367341|O2|Outcome|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
495480|NCT00367341|O1|Outcome|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
495481|NCT00367341|E2|Reported Event|Cognitive Behavioral Therapy|Cognitive Behavioral Therapy (CBT) : CBT will include 16 1 hour sessions provided over 12 weeks.
495482|NCT00367341|E1|Reported Event|Escitalopram|escitalopram : Participants will receive treatment with escitalopram for 12 weeks.
495483|NCT00367237|B3|Baseline|Total|Total of all reporting groups
495484|NCT00367237|B2|Baseline|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
495485|NCT00367237|B1|Baseline|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
495486|NCT00367237|P2|Participant Flow|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
495487|NCT00367237|P1|Participant Flow|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
495488|NCT00367237|O2|Outcome|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
495489|NCT00367237|O1|Outcome|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
495490|NCT00367237|E2|Reported Event|Methotrexate (MTX)|Oral methotrexate (MTX) 15 mg/week
495491|NCT00367237|E1|Reported Event|Infliximab + Methotrexate (IFX + MTX)|Remicade (infliximab [IFX]) 5 mg/kg infusions at Weeks 0, 2, 6, 14 and oral methotrexate (MTX) 15 mg/week
495492|NCT00367133|B4|Baseline|Total|Total of all reporting groups
495493|NCT00367133|B3|Baseline|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495494|NCT00367133|B2|Baseline|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495495|NCT00367133|B1|Baseline|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495496|NCT00367133|P3|Participant Flow|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495497|NCT00367133|P2|Participant Flow|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495498|NCT00367133|P1|Participant Flow|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495499|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495500|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495501|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495502|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495503|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495504|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495505|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495506|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495507|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495508|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495509|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495510|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495511|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495512|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495513|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495514|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495515|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495516|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495866|NCT00365859|O4|Outcome|Total|
495519|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495520|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495521|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495522|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495523|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495524|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495525|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495526|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495527|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495528|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495529|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495530|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495531|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495532|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495533|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495534|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495535|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495536|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495537|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495538|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495539|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495540|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495541|NCT00367133|O3|Outcome|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495542|NCT00367133|O2|Outcome|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495543|NCT00367133|O1|Outcome|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495544|NCT00367133|E3|Reported Event|4 mg Intravitreal Triamcinolone|Intravitreal injection of 4mg of triamcinolone acetonide
495545|NCT00367133|E2|Reported Event|1mg Intravitreal Triamcinolone|Intravitreal injection of 1mg of triamcinolone acetonide
495546|NCT00367133|E1|Reported Event|Focal/Grid Laser Photocoagulation|Standard of care group: conventional treatment consisting of focal/grid photocoagulation.
495547|NCT00367055|B3|Baseline|Total|Total of all reporting groups
495548|NCT00367055|B2|Baseline|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495549|NCT00367055|B1|Baseline|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495550|NCT00367055|P2|Participant Flow|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495551|NCT00367055|P1|Participant Flow|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495552|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495553|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495554|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495555|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495556|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495557|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495558|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495559|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495560|NCT00367055|O2|Outcome|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495820|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495561|NCT00367055|O1|Outcome|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495562|NCT00367055|E2|Reported Event|Gliclazide + Metformin 80 mg/2 g/Day|Initial dose of gliclazide + metformin 80 mg/2 g/day; allowed adjustment of up to 160 mg/2 g/day after 4 weeks, up to 240 mg/2 g/day after 8 weeks, up to 320 mg/2 g/day after 3 months
495563|NCT00367055|E1|Reported Event|Rosiglitazone + Metformin 4 mg/2 g/Day|Initial dose of rosiglitazone + metformin of 4 milligrams (mg)/2 grams (g)/day; allowed adjustment of up to 8 mg/2 g/day after 8 weeks
495564|NCT00366899|B3|Baseline|Total|Total of all reporting groups
495565|NCT00366899|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
495566|NCT00366899|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
495567|NCT00366899|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
495568|NCT00366899|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with diphtheria-tetanus-acellular pertussis (DTPa), hepatitis B, inactivated poliovirus, and hemophilus influenza type b (Hib) vaccine (Infanrix hexa) at 3 and 5 months (infant series), and 11 months of age (toddler dose).
495569|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
495570|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 12 months of age (toddler dose).
495571|NCT00366899|O2|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495572|NCT00366899|O1|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495573|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495574|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495575|NCT00366899|O2|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495576|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495577|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495578|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495579|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495580|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495581|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495582|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495583|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495584|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495585|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495586|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495587|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495588|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495589|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495590|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495591|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495592|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495593|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495594|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495595|NCT00366899|O2|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495596|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495597|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495598|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495599|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495600|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Subjects received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495601|NCT00366899|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495602|NCT00366899|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age (toddler dose).
495603|NCT00366899|O2|Outcome|7vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495604|NCT00366899|O1|Outcome|13vPnC After 2-Dose Infant Series|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months of age (infant series).
495605|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
495606|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
495607|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
495608|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
495609|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
495610|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
495611|NCT00366899|O6|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 11 months of age.
495612|NCT00366899|O5|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 11 months of age.
495613|NCT00366899|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 5 months of age.
495614|NCT00366899|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 5 months of age.
495615|NCT00366899|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7vPnC coadministered with Infanrix hexa at 3 months of age.
495616|NCT00366899|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13vPnC coadministered with Infanrix hexa at 3 months of age.
495617|NCT00366899|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
495618|NCT00366899|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months (infant series) and 11 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
495619|NCT00366899|E6|Reported Event|7vPnC Toddler Series|Participants received one single 0.5mL dose of 7vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
495620|NCT00366899|E5|Reported Event|13vPnC Toddler Series|Participants received one single 0.5mL dose of 13vPnC at 11 months of age. Adverse events were collected for approximately one month after toddler dose.
495621|NCT00366899|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
495622|NCT00366899|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from approximately one month after dose 2 to toddler dose.
495623|NCT00366899|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
495624|NCT00366899|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 3 and 5 months. Adverse events were collected from dose 1 to approximately one month after dose 2.
495625|NCT00366548|B3|Baseline|Total|Total of all reporting groups
495626|NCT00366548|B2|Baseline|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
495627|NCT00366548|B1|Baseline|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
495821|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495628|NCT00366548|P2|Participant Flow|13vPnC Without (-) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) without (-) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
495629|NCT00366548|P1|Participant Flow|13vPnC With (+) Polysorbate 80|Participants received one single 0.5mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) with (+) P80 coadministered with combination vaccine containing diphtheria, tetanus, acellular pertussis, inactivated poliovirus, and conjugated Hib antigens (Pentaxim) and hepatitis B recombinant vaccine adsorbed (Engerix-B) at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant series), and combined vaccine containing attenuated measles, mumps, and rubella viruses (Priorix) at 12 months of age (toddler dose).
495630|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
495631|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
495632|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495633|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495634|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495635|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495636|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
495637|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
495638|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
495639|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
495640|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
495641|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
495642|NCT00366548|O8|Outcome|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
495643|NCT00366548|O7|Outcome|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series), and Priorix at 12 months of age (toddler dose).
495644|NCT00366548|O6|Outcome|13vPnC - P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
495645|NCT00366548|O5|Outcome|13vPnC + P80 Dose 3 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant series, Dose 3).
495646|NCT00366548|O4|Outcome|13vPnC - P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
495647|NCT00366548|O3|Outcome|13vPnC + P80 Dose 2 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 months age (infant series, Dose 2).
495648|NCT00366548|O2|Outcome|13vPnC - P 80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age (infant series, Dose 1).
495649|NCT00366548|O1|Outcome|13vPnC + P80 Dose 1 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age(infant series, Dose 1).
495650|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at the 2 month visit, Pentaxim at the 3 and 4 month visits, and Priorix at 12 months of age (toddler dose).
495651|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at approximately 2 months of age, Pentaxim at approximately 3 months and 4 months of age (infant doses), and Priorix at 12 months of age (toddler dose).
495652|NCT00366548|O2|Outcome|13vPnC - Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
503624|NCT00340379|E2|Reported Event|Sertraline/Haloperidol|
495653|NCT00366548|O1|Outcome|13vPnC + Polysorbate 80 After the Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495654|NCT00366548|E8|Reported Event|13vPnC - P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495655|NCT00366548|E7|Reported Event|13vPnC + P80 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495656|NCT00366548|E6|Reported Event|13vPnC - P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495657|NCT00366548|E5|Reported Event|13vPnC + P80 Toddler Dose|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495658|NCT00366548|E4|Reported Event|13vPnC - P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495659|NCT00366548|E3|Reported Event|13vPnC + P80 Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495660|NCT00366548|E2|Reported Event|13vPnC - P 80 Infant Series|Participants received one single 0.5mL dose of 13vPnC - P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495661|NCT00366548|E1|Reported Event|13vPnC + P80 Infant Series|Participants received one single 0.5mL dose of 13vPnC + P80 coadministered with Pentaxim and Engerix-B at 2 months of age, Pentaxim at 3 and 4 months age (infant doses), and Priorix at 12 months of age (toddler dose).
495662|NCT00366444|B3|Baseline|Total|Total of all reporting groups
495663|NCT00366444|B2|Baseline|Placebo|Oral placebo capsule, every 6 hours
495664|NCT00366444|B1|Baseline|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495665|NCT00366444|P2|Participant Flow|Placebo|Oral placebo capsule, every 6 hours
495666|NCT00366444|P1|Participant Flow|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495667|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495668|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495669|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495670|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495671|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495672|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495673|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495674|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495675|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495676|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495677|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495678|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495679|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495680|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495681|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495682|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495683|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495684|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495685|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495686|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495687|NCT00366444|O2|Outcome|Placebo|Oral placebo capsule, every 6 hours
495688|NCT00366444|O1|Outcome|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495689|NCT00366444|E2|Reported Event|Placebo|Oral placebo capsule, every 6 hours
495690|NCT00366444|E1|Reported Event|Zipsor (Diclofenac Potassium) Liquid Filled Capsule|25 mg capsule, every 6 hours
495691|NCT00366340|B3|Baseline|Total|Total of all reporting groups
495692|NCT00366340|B2|Baseline|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
495693|NCT00366340|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
495694|NCT00366340|P2|Participant Flow|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
495695|NCT00366340|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
503625|NCT00340379|E1|Reported Event|Ziprasidone|
495696|NCT00366340|O2|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
495697|NCT00366340|O1|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
495698|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
495699|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
495700|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
495701|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
495702|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
495703|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
495704|NCT00366340|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
495705|NCT00366340|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age.
495706|NCT00366340|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
495707|NCT00366340|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 4 months (infant series).
495708|NCT00366340|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
495709|NCT00366340|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 3 months (infant series).
495710|NCT00366340|O2|Outcome|7vPnC Dose 1|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
495711|NCT00366340|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2 months (infant series).
495712|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
495713|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
495714|NCT00366340|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495715|NCT00366340|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495716|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
495717|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
495867|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495718|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495719|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495720|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
495721|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
495722|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495723|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495724|NCT00366340|O4|Outcome|7vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
495725|NCT00366340|O3|Outcome|13vPnC AfterToddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
495726|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495727|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495728|NCT00366340|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose)
495729|NCT00366340|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 12 months of age (toddler dose).
495730|NCT00366340|O2|Outcome|7vPnC After Infant Series|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495731|NCT00366340|O1|Outcome|13vPnC After Infant Series|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series).
495732|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
495733|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
495734|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
495735|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
495736|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
495737|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
495738|NCT00366340|O2|Outcome|7vPnC|Participants received one single 0.5 mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose)
503626|NCT00339833|B3|Baseline|Total|Total of all reporting groups
495739|NCT00366340|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with combined Diphtheria-Tetanus-acellular Pertussis (DTPa), Hepatitis B, Poliovirus and Haemophilus influenzae type b vaccine (Infanrix hexa) at 2, 3, 4 months (infant series) and 12 months of age (toddler dose).
495740|NCT00366340|E8|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
495741|NCT00366340|E7|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected for approximately six months after last visit.
495742|NCT00366340|E6|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
495743|NCT00366340|E5|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC at 12 months of age. Adverse events were collected for approximately one month after toddler dose.
495744|NCT00366340|E4|Reported Event|7vPnC Post-Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months (infant series) and 12 months of age (toddler dose). Adverse events were collected from approximately one month after dose 3 to toddler dose.
495745|NCT00366340|E3|Reported Event|13vPnC Post-Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from approximately one month after dose 3 to toddler dose.
495746|NCT00366340|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
495747|NCT00366340|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with Infanrix hexa at 2, 3, 4 months. Adverse events were collected from dose 1 to approximately one month after dose 3.
495748|NCT00366301|B5|Baseline|Total|Total of all reporting groups
495749|NCT00366301|B4|Baseline|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
495750|NCT00366301|B3|Baseline|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
495751|NCT00366301|B2|Baseline|Metformin Pill|Metformin pill
495752|NCT00366301|B1|Baseline|Placebo Pill|Placebo pill
495753|NCT00366301|P4|Participant Flow|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
495754|NCT00366301|P3|Participant Flow|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
495755|NCT00366301|P2|Participant Flow|Metformin Pill|Metformin pill
495756|NCT00366301|P1|Participant Flow|Placebo Pill|Placebo pill
495757|NCT00366301|O4|Outcome|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
495758|NCT00366301|O3|Outcome|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
495759|NCT00366301|O2|Outcome|Metformin Pill|Metformin pill
495760|NCT00366301|O1|Outcome|Placebo Pill|Placebo pill
495761|NCT00366301|E4|Reported Event|Insulin Glargine Plus Metformin Pill|Insulin Glargine plus metformin pill
495762|NCT00366301|E3|Reported Event|Insulin Glargine Plus Placebo Pill|Insulin glargine plus placebo pill
495763|NCT00366301|E2|Reported Event|Metformin Pill|Metformin pill
495764|NCT00366301|E1|Reported Event|Placebo Pill|Placebo pill
495765|NCT00366275|B1|Baseline|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
495766|NCT00366275|P1|Participant Flow|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
495767|NCT00366275|O1|Outcome|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
495792|NCT00366106|E1|Reported Event|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495793|NCT00366028|B3|Baseline|Total|Total of all reporting groups
495822|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495768|NCT00366275|E1|Reported Event|Immunochemotherapy, in Vivo Purging and Autotransplant|2-4 courses every 3 weeks with rituximab 375 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 2 and cyclophosphamide 400 mg/m^2 on days 2-6. Courses were started if granulocytes >1.5 · 109/l. The phase of peripheral blood stem cells (PBSC) mobilization coupled rituximab 375 mg/m^2 on days 1 and 9 with high-dose cytarabine (AraC) 2 g/m^2 every 12 hours on days 2 and 3. Granulocyte colony-stimulating factor (G-CSF)(5 mcg/kg/day s.c.) was administered from day 6. High-dose chemotherapy with autotransplant consisted of BEAM [carmustine (BCNU), etoposide, Cytarabine (AraC), melphalan] followed by the infusion of in vivo purged peripheral blood stem cells (PBSC) + 2 consolidation doses of rituximab 375 mg/m^2 on days +14 and +21 after autotransplant.
495769|NCT00366249|B3|Baseline|Total|Total of all reporting groups
495770|NCT00366249|B2|Baseline|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495771|NCT00366249|B1|Baseline|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495772|NCT00366249|P2|Participant Flow|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495773|NCT00366249|P1|Participant Flow|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495774|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495775|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495776|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495777|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495778|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495779|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495780|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495781|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495782|NCT00366249|O2|Outcome|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495783|NCT00366249|O1|Outcome|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495784|NCT00366249|E2|Reported Event|Ertapenem|Ertapenem 1g IV infusion every 24 hours +/- vancomycin depending on culture results and at the discretion of investigator (for coverage of Methicillin-resistant Staphylococcus aureus (MRSA), coagulase-negative staphylococci (CNS) or enterococci coverage).
495785|NCT00366249|E1|Reported Event|Tigecycline|Tigecycline 150 mg IV infusion every 24 hours
495786|NCT00366106|B1|Baseline|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495787|NCT00366106|P1|Participant Flow|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495788|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495789|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495790|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495791|NCT00366106|O1|Outcome|Treatment Group|All subjects received bortezomib 1.3mg/m^2 on Days 1, 4, 15, and 18 every 28 days and dexamethasone 20mg daily on Days 1, 2, 4, 5, 15, 16, 18, and 19 every 28 days. Following US FDA approval of doxorubicin HCl liposome injection in combination with bortezomib in May 2007, the study was amended to allow combination treatment with both bortezomib and doxorubicin HCl liposome injection 30 mg/m^2 on Day 4 every 28 days with dexamethasone. The target goal was 8 cycles of treatment.
495819|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495794|NCT00366028|B2|Baseline|Data Feedback|"Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Only Model: The research team will periodically interview the facilities and provide them with reported hand hygiene data."
495795|NCT00366028|B1|Baseline|Organizational Model|"Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
495796|NCT00366028|P2|Participant Flow|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
495797|NCT00366028|P1|Participant Flow|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two."
495798|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 9 study sites (medical centers) in total. Only 5 of the study sites are included in analysis of this outcome measure due to incomplete hand hygiene data at 4 of the study sites. Of the 5 study sites included, there were 2 sites with high fidelity to the Organization Model and 3 sites with low fidelity to the Organizational model, even though the model was not specifically introduced to the control arm."
495799|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 7 study sites (medical centers). Of the 7 sites there were 4 with high fidelity to the Organizational Model and 3 with low fidelity to the Organizational Model."
495800|NCT00366028|O2|Outcome|Data Feedback|"Participants in this arm were interviewed periodically and participated in the data feedback portion of the study but did not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team periodically interviewed the facilities and provided them with reported hand hygiene data.~The Control Arm included 735 individual participants across 9 study sites (medical centers) in total. Only 5 of the study sites are included in the reporting of outcome data due to incomplete data at 4 of the study sites."
495801|NCT00366028|O1|Outcome|Organizational Model|"Participants in this arm of the study received information regarding the organizational model and worked closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~The Intervention Arm included 889 individual participants across 7 study sites (medical centers)."
495802|NCT00366028|E2|Reported Event|Data Feedback|"This arm is considered the control arm. Participants in this arm will be interviewed periodically and participate in the data feedback portion of the study but will not undergo any active intervention pertaining to the organizational model.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
495803|NCT00366028|E1|Reported Event|Organizational Model|"This arm is considered the intervention arm. Participants in this arm of the study will receive information regarding the organizational model and work closely with the research team throughout the project to implement various aspects of the model.~Organization Model: The organizational model contains three components: leadership support, a multidisciplinary redesign team, and management structures and processes to link the two.~Data Feedback Model: This is considered the non-intervention arm. The research team will periodically interview the facilities and provide them with reported hand hygiene data."
495804|NCT00365976|B3|Baseline|Total|Total of all reporting groups
495805|NCT00365976|B2|Baseline|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495806|NCT00365976|B1|Baseline|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495807|NCT00365976|P2|Participant Flow|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495808|NCT00365976|P1|Participant Flow|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495809|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495810|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495811|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495812|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495813|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495814|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495815|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495816|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495817|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495818|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495824|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495825|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495826|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495827|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495828|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495829|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495830|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495831|NCT00365976|O2|Outcome|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495832|NCT00365976|O1|Outcome|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495833|NCT00365976|E2|Reported Event|Placebo|Placebo : Placebo nightly over duration of double blind study phase.
495834|NCT00365976|E1|Reported Event|Eszopiclone|Eszopiclone : Eszopiclone 3 mg po nightly for duration of study blind phase.
495835|NCT00365872|B4|Baseline|Total|Total of all reporting groups
495836|NCT00365872|B3|Baseline|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495837|NCT00365872|B2|Baseline|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495838|NCT00365872|B1|Baseline|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495839|NCT00365872|P3|Participant Flow|COHORT 3: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495840|NCT00365872|P2|Participant Flow|COHORT 2: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495841|NCT00365872|P1|Participant Flow|COHORT 1: EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday). Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495842|NCT00365872|O3|Outcome|Single Arm - Cohort 3|DC injection # 4 given 72 hours prior to surgery
495843|NCT00365872|O2|Outcome|Single Arm - Cohort 2|DC injection # 4 given 48 hours prior to surgery
495844|NCT00365872|O1|Outcome|Single Arm - Cohort 1|DC injection # 4 given 24 hours prior to surgery
495868|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495869|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495870|NCT00365859|O4|Outcome|Total|
495871|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495872|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495873|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495874|NCT00365859|O4|Outcome|Total|
495845|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495846|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495847|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495848|NCT00365872|O1|Outcome|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495849|NCT00365872|E1|Reported Event|EBRT + DC Injection + Resection|"Single Arm: EBRT + DC Injection + Resection. Prior to the fourth DC Injection, participants were assigned to 3 cohorts for that injection only.~Dendritic Cell (DC) Injections: DCs (10^7 cells) were injected intratumorally three times on the second, third, and fourth Friday during the course of radiation. One additional DC injection was given before surgery to assess DC migration. Patients were assigned to one of three cohorts: Group 1 - DC injection # 4 given 24 hours prior to surgery, Group 2 - DC injection # 4 given 48 hours prior to surgery, Group 3 - DC injection # 4 given 72 hours prior to surgery.~Radiation was delivered 5 days per week (Monday-Friday).~Complete Resection - Surgery for tumor removal: Tumors were surgically resected 3-6 weeks after the completion of EBRT."
495850|NCT00365859|B4|Baseline|Total|Total of all reporting groups
495851|NCT00365859|B3|Baseline|Rollover Aripiprazole|As previously described in Participant Flow
495852|NCT00365859|B2|Baseline|Rollover Placebo|As previously described in Participant Flow
495853|NCT00365859|B1|Baseline|De Novo|As previously described in Participant Flow
495854|NCT00365859|P4|Participant Flow|Total|
495855|NCT00365859|P3|Participant Flow|Rollover Aripiprazole|Participants who completed participation in protocol CN138-178 [NCT00332241] or CN138-179 [NCT00337571] on aripiprazole treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
495856|NCT00365859|P2|Participant Flow|Rollover Placebo|Participants who completed participation in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) on placebo treatment and continued to meet all of the inclusion criteria and none of the exclusion criteria. Assigned in this study to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
495857|NCT00365859|P1|Participant Flow|De Novo|De novo participants (those who did not participate in protocol (CN138-178 [NCT00332241] or CN138-179 [NCT00337571]) assigned to open-label aripiprazole (oral tablet), flexibly dosed (2 to 15 mg/day) taken once daily, started at 2 mg/day on Day 1. Target daily dose was 5 mg, 10 mg, or 15 mg; maximum dose, regardless of weight, was 15 mg. Dose increases were incremental (dose levels are 2 mg, 5 mg, 10 mg, and 15 mg), occurring no more often than every 4 days, and were based on assessment of efficacy and tolerability at the current dose. The dosage could be adjusted downward if the patient experienced intolerance at any time to the current dose.
495858|NCT00365859|O4|Outcome|Total|
495859|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495860|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495861|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495862|NCT00365859|O4|Outcome|Total|
495863|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495864|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495875|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495876|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495877|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495878|NCT00365859|O4|Outcome|Total|
495879|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495880|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495881|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495882|NCT00365859|O4|Outcome|Total|
495883|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495884|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495885|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495886|NCT00365859|O4|Outcome|Total|
495887|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495888|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495889|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495890|NCT00365859|O4|Outcome|Total|
495891|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495892|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495893|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495894|NCT00365859|O4|Outcome|Total|
495895|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495896|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495897|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495898|NCT00365859|O4|Outcome|Total|
495899|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495900|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495901|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495902|NCT00365859|O4|Outcome|Total|
495903|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495904|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495905|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495906|NCT00365859|O4|Outcome|Total|
495907|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495908|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495909|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495910|NCT00365859|O4|Outcome|Total|
495911|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495912|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495913|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495914|NCT00365859|O4|Outcome|Total|
495915|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495916|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495917|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495918|NCT00365859|O4|Outcome|Total|
495919|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495920|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495921|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495922|NCT00365859|O4|Outcome|Total|
495923|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495924|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495925|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495926|NCT00365859|O4|Outcome|Total|
495927|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495928|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495929|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495930|NCT00365859|O4|Outcome|Total|
495931|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495932|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495933|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495934|NCT00365859|O4|Outcome|Total|
495935|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495936|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495937|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495938|NCT00365859|O4|Outcome|Total|
495939|NCT00365859|O3|Outcome|Rollover Aripiprazole|As previously described in Participant Flow
495940|NCT00365859|O2|Outcome|Rollover Placebo|As previously described in Participant Flow
495941|NCT00365859|O1|Outcome|De Novo|As previously described in Participant Flow
495942|NCT00365859|E3|Reported Event|Roll Over Placebo|
495943|NCT00365859|E2|Reported Event|Roll Over Aripiprazole|
495944|NCT00365859|E1|Reported Event|De Novo|
495945|NCT00365846|B1|Baseline|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495946|NCT00365846|P1|Participant Flow|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495947|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495948|NCT00365846|O1|Outcome|Group 1Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction w/ Sirolimus immunosuppression
495949|NCT00365846|O1|Outcome|Campath 1H Induction w/ Sirolimus Immunosuppression|Campath 1H induction on Day -1 and 0 of renal transplant followed w/ Sirolimus maintenance immunosuppression
495950|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495951|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495952|NCT00365846|O1|Outcome|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495953|NCT00365846|E1|Reported Event|Group 1|Campath 1H induction w/ Sirolimus immunosuppression
495954|NCT00365768|B3|Baseline|Total|Total of all reporting groups
495955|NCT00365768|B2|Baseline|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
495956|NCT00365768|B1|Baseline|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
495957|NCT00365768|P2|Participant Flow|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
495958|NCT00365768|P1|Participant Flow|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
495959|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
495960|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
495961|NCT00365768|O2|Outcome|Arm II: Placebo|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
495962|NCT00365768|O1|Outcome|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
495963|NCT00365768|E2|Reported Event|Arm II|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral placebo twice daily on days 1-21.~Placebo: Administered orally twice daily for 21 days"
495964|NCT00365768|E1|Reported Event|Arm I: Glutamine|"Beginning 1 week after administration of vincristine chemotherapy, patients receive oral glutamine twice daily on days 1-21.~Glutamine: Administered orally twice daily for 21 days"
495965|NCT00365716|B6|Baseline|Total|Total of all reporting groups
495966|NCT00365716|B5|Baseline|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495967|NCT00365716|B4|Baseline|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495968|NCT00365716|B3|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495969|NCT00365716|B2|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495970|NCT00365716|B1|Baseline|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495971|NCT00365716|P7|Participant Flow|Extension 2|This group includes 17 subjects from the United States, who received placebo during the base study and received 3 doses of qHPV vaccine during the Extension, or received less than 3 doses of the qHPV Vaccine during the base study and completed the dose regimen during the Extension.
495972|NCT00365716|P6|Participant Flow|Extension 1|This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.
495973|NCT00365716|P5|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495974|NCT00365716|P4|Participant Flow|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495975|NCT00365716|P3|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495976|NCT00365716|P2|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495977|NCT00365716|P1|Participant Flow|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495978|NCT00365716|O2|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225 or 450 Combined|For the purposes of this outcome measure, the placebo groups (225 mcg and 450 mcg) were combined.
495979|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495980|NCT00365716|O5|Outcome|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495981|NCT00365716|O4|Outcome|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495982|NCT00365716|O3|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495983|NCT00365716|O2|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495984|NCT00365716|O1|Outcome|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495985|NCT00365716|E6|Reported Event|Extensions|"This group includes 241 international subjects, who either: (1) received placebo during the base study and continued in the Extension to receive a dose of GARDASIL (20/40/40/20 mcg formulation of qHPV vaccine) at Month 60 (plus 2 and 3 at Months 62 and 66, respectively, (2) received 3 doses of GARDASIL during the Base study and continued into the Extension to receive a fourth dose of GARDASIL at Month 60 for the purposes of investigating whether a fourth dose of vaccine (administered ~4.5 years following completion of a 3-dose primary regimen) induces HPV 6, 11, 16, and 18 antibody responses that characterize immune therapy.~Serious Adverse Events (SAEs) were collected during Extension 1 and Extension 2. Note that the N includes only the 241 subjects vaccinated during the Extension Periods; of the 258 subjects that entered either Extension, 17 subjects discontinued before being vaccinated and therefore are not included in this table."
495986|NCT00365716|E5|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 450|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 5 received placebo containing 450 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495987|NCT00365716|E4|Reported Event|Placebo (mcg) (Aluminum Adjuvant) 225|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 4 received placebo containing 225 mcg of aluminum adjuvant per dose at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
496009|NCT00365508|P1|Participant Flow|Nicotine Patch|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
496229|NCT00365105|E2|Reported Event|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
495988|NCT00365716|E3|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 80/80/40/80|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 3 received a 80/80/40/80 formulation of quadrivalent human papillomavirus (qHPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the qHPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36."
495989|NCT00365716|E2|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 40/40/40/40|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 2 received a 40/40/40/40 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There were 2 patients from the 40/40/40/40 group that were randomized, but were never vaccinated. As such, these 2 patients are not included in this table."
495990|NCT00365716|E1|Reported Event|Quadrivalent HPV (Types 6,11,16,18) L1 VLP Vaccine 20/40/40/20|"The Vaccination Period for the Base Study encompassed Day 1 through Month 7, during which time subjects in Group 1 received a 20/40/40/20 formulation of quadrivalent human papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) vaccine at Day 1, Month 2, and Month 6.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine or placebo from completion of the Vaccination Period at Month 7 through Month 36.~There was one subject randomized to the quadrivalent HPV (Types 6, 11, 16, 18) L1 VLP vaccine 20/40/40/20 mcg group who received the 225 mcg aluminum adjuvant placebo at the third vaccination visit. This subject was not included in the counts reported in the Adverse Event tables. No SAEs were reported for this subject.~There was 1 patient that was randomized, but never vaccinated. As such, that patient is not included in this table."
495991|NCT00365599|B1|Baseline|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495992|NCT00365599|P1|Participant Flow|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495993|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495994|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495995|NCT00365599|O1|Outcome|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495996|NCT00365599|E1|Reported Event|Vorinostat and Tamoxifen|Vorinostat and Tamoxifen as outlined in Intervention Descriptions
495997|NCT00365547|B1|Baseline|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
495998|NCT00365547|P1|Participant Flow|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
495999|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
496000|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
496001|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Patients that met Solid Tumor Response Criteria (RECIST) criteria for partial response (at least a 30% decrease in the sum of the longest diameters of target lesions) and complete response (disappearance of all target lesions).
496002|NCT00365547|O1|Outcome|Patients Evaluable for Tumor Response|Only patients that remained in the study for at least 2 months and had the tumor measurements necessary to meet RECIST criteria are included.
496003|NCT00365547|O1|Outcome|Intent-To-Treat Population|Patients who enrolled and were scheduled to receive weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab) given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
496004|NCT00365547|E1|Reported Event|Safety Population|Patients who received treatment with weekly topotecan (4 mg/m^2 will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22 and repeated every 28 days) and bi-weekly Avastin (bevacizumab given by IV infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration)in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
496005|NCT00365508|B3|Baseline|Total|Total of all reporting groups
496006|NCT00365508|B2|Baseline|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
496007|NCT00365508|B1|Baseline|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
496008|NCT00365508|P2|Participant Flow|Nicotine Lozenge|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
496223|NCT00365105|B2|Baseline|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
503627|NCT00339833|B2|Baseline|Placebo|Identical placebo for 7 days
496010|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
496011|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
496012|NCT00365508|O2|Outcome|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
496013|NCT00365508|O1|Outcome|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
496014|NCT00365508|E2|Reported Event|Arm II|Participants receive one oral nicotine lozenge every 1-2 hours in weeks 3-8 (≥ 9 lozenges per day), one lozenge every 2-4 hours in weeks 9-11 (≥ 5 lozenges per day), and 1 lozenge every 4-8 hours in weeks 12-14 (≥ 3 lozenges per day).
496015|NCT00365508|E1|Reported Event|Arm I|Participants apply a transdermal nicotine patch at 3 different time periods during weeks 3-14; a higher-dose patch is applied for weeks 3-8, a medium-dose patch is applied for weeks 9-10, and a lower-dose patch is applied for weeks 11-14.
496016|NCT00365456|B1|Baseline|PTH(1-84) or Risedronate|"PTH(1-84) received by 405 participants in Trial Period I~of those 405 participants, 282 received Risedronate in Trial Period II~of those 282 participants, 268 participant remained and 136 received PTH(1-84) and 132 received Risedronate in Trial Period III"
496017|NCT00365456|P2|Participant Flow|Risedronate|
496018|NCT00365456|P1|Participant Flow|PTH (1-84)|
496019|NCT00365456|O2|Outcome|Risedronate|Regimen 2 = PTH (1-84) → Risedronate → Risedronate
496020|NCT00365456|O1|Outcome|PTH (1-84)|Regimen 1 = PTH (1-84) → Risedronate → PTH (1-84)
496021|NCT00365456|E2|Reported Event|Risedronate|Trial Period II SAEs and Trial Period III SAEs for subjects receiving risedronate
496022|NCT00365456|E1|Reported Event|PTH (1-84)|Trial Period I SAEs and Trial Period III SAEs for subjects receiving PTH (1-84)
496023|NCT00365417|B1|Baseline|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
496024|NCT00365417|P1|Participant Flow|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
496025|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
496026|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
496027|NCT00365417|O1|Outcome|Neoadjuvant Study Treatment|Doxorubicin, cyclophosphamide, and bevacizumab followed by docetaxel and capecitabine
496028|NCT00365417|E1|Reported Event|Chemo Plus Bevacizumab|Bevacizumab beginning concurrently with a sequential regimen of doxorubicin and cyclophosphamide followed by docetaxel and capecitabine as neoadjuvant therapy followed by postoperative bevacizumab alone for women with HER2 negative locally advanced breast cancer
496029|NCT00365391|B1|Baseline|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496030|NCT00365391|P1|Participant Flow|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine epidermal growth factor receptor (EGFR) and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by immuno-histochemistry (IHC) for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, mitogen-activated protein kinase (MAPK), and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496031|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496032|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
503628|NCT00339833|B1|Baseline|Salsalate|Salsalate (3g/day) for 7 days
496033|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496034|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496035|NCT00365391|O1|Outcome|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496036|NCT00365391|E1|Reported Event|Treatment (Bevacizumab and Erlotinib)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients undergo laboratory studies to determine EGFR and phosphorylated-EGFR protein levels using initial diagnostic biopsy specimens by IHC for correlation with clinical outcome. Levels of proteins through which EGFR signals, including Akt, phosphorylated-Akt, MAPK, and phosphorylated-MAPK, are also determined using initial diagnostic biopsy specimens by IHC and correlated with clinical outcome. Total and free serum vascular endothelial growth factor levels are determined at the start of study and prior to course 3 by ELISA.
496037|NCT00365378|B3|Baseline|Total|Total of all reporting groups
496038|NCT00365378|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
496039|NCT00365378|B1|Baseline|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
496040|NCT00365378|P3|Participant Flow|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
496041|NCT00365378|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
496042|NCT00365378|P1|Participant Flow|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48. (The Month 7 visit was to be scheduled to occur no earlier than 3 weeks and no later than 7 weeks following the Month 6 visit.)"
496043|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
496044|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
496045|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
496046|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
496224|NCT00365105|B1|Baseline|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
496230|NCT00365105|E1|Reported Event|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
496047|NCT00365378|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2, and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo from completion of the Vaccination Period at Month 7 through Month 48."
496048|NCT00365378|O1|Outcome|HPV 16 L1 VLP (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2, and Month 6) with HPV (Human Papillomavirus) 16 Virus-Like Particle (VLP) Vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the HPV 16 VLP Vaccine from completion of the Vaccination Period at Month 7 through Month 48."
496049|NCT00365378|E3|Reported Event|Extension|This group includes 400 subjects who received Monovalent HPV 16 L1 VLP vaccine or placebo during the base study. This includes subjects who previously discontinued from the study.
496050|NCT00365378|E2|Reported Event|Placebo (Group 2)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
496051|NCT00365378|E1|Reported Event|HPV 16 L1 VLP (Group 1)|The number of subjects who actually received the vaccine material corresponding to the indicated vaccination group. There was one subject randomized to the HPV 16 L1 VLP vaccine group who received placebo and then discontinued study participation. There was 1 subject randomized to the placebo group who received one vaccination of HPV 16 L1 VLP vaccine and then discontinued study participation. These 2 subjects were included in the counts reported in the Adverse Event tables. There were 2 subjects randomized to the HPV 16 L1 VLP vaccine group and 2 subjects randomized to the placebo group and who received mixed vaccine material. These 4 subjects were not included in the counts reported in this table. Therefore, this table reports N=1191 (1193 minus 2) subjects vaccinated with HPV 16 L1 VLP vaccine and N=1196 (1198 minus 2) subjects vaccinated with placebo.
496052|NCT00365365|B4|Baseline|Total|Total of all reporting groups
496053|NCT00365365|B3|Baseline|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496054|NCT00365365|B2|Baseline|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496055|NCT00365365|B1|Baseline|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496056|NCT00365365|P3|Participant Flow|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496057|NCT00365365|P2|Participant Flow|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496058|NCT00365365|P1|Participant Flow|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496059|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496060|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496061|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496062|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496063|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496064|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496065|NCT00365365|O3|Outcome|Stratum 3 (TCH + Bevacizumab).)|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
497603|NCT00361270|P3|Participant Flow|Hypnosis Practice 2|2 sessions of hypnosis with practice cds
496066|NCT00365365|O2|Outcome|Stratum 2 (TAC + Bevacizumab)|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496067|NCT00365365|O1|Outcome|Stratum 1 (AC->T + Bevacizumab)|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496068|NCT00365365|E3|Reported Event|TCH + Bevacizumab|"All HER2-positive participants administered~docetaxel, carboplatin, trastuzumab (TCH) + bevacizumab for 6 cycles followed by~bevacizumab and trastuzumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496069|NCT00365365|E2|Reported Event|TAC + Bevacizumab|"HER2-negative participants administered~docetaxel, doxorubicin, cyclophosphamide (TAC) + bevacizumab for 6 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496070|NCT00365365|E1|Reported Event|AC->T + Bevacizumab|"HER2-negative participants administered~doxorubicin and cyclophosphamide (AC) + bevacizumab for 4 cycles followed by~docetaxel (T) + bevacizumab for 4 cycles followed by~bevacizumab maintenance therapy for total of 52 weeks from date of first dose regardless of number of doses received or missed"
496071|NCT00365352|B4|Baseline|Total|Total of all reporting groups
496072|NCT00365352|B3|Baseline|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496073|NCT00365352|B2|Baseline|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496074|NCT00365352|B1|Baseline|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496075|NCT00365352|P3|Participant Flow|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496076|NCT00365352|P2|Participant Flow|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496077|NCT00365352|P1|Participant Flow|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496078|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496079|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496080|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496081|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496082|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496083|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496084|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496085|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496086|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496087|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496088|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496089|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496090|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496091|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496092|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496093|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496094|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496095|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496096|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496097|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496098|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496099|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496100|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496101|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496102|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496103|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496104|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496105|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496106|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496107|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496108|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496109|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496110|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496111|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496112|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496113|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496114|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496115|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496116|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496117|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496118|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496119|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496120|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496121|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496122|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496123|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496124|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496125|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496126|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496127|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496128|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496129|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496130|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496131|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496132|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496133|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496225|NCT00365105|P2|Participant Flow|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
496134|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496135|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496136|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496137|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496138|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496139|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496140|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496141|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg Taken Orally Once a Day|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496142|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 Milligrams(mg) Taken Orally|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496143|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496144|NCT00365352|O3|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496145|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496146|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496147|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496148|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496149|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496150|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496151|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496152|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496153|NCT00365352|O2|Outcome|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496154|NCT00365352|O1|Outcome|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496155|NCT00365352|E3|Reported Event|GEn (XP13512/GSK1838262) 1200 mg|Oral GEn (gabapentin enacarbil) 1200 milligrams (mg) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: two ER tablets (1200 mg GEn). On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one ER tablet (600 mg GEn).
496156|NCT00365352|E2|Reported Event|GEn (XP13512/GSK1838262) 600 mg|Gabapentin enacarbil (GEn) (XP13512/GSK1838262) 600 milligrams (mg) taken orally once a day for 12 weeks) taken once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 84: one ER tablet (600 mg GEn) and one placebo tablet. On Day 85, participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496157|NCT00365352|E1|Reported Event|Placebo|Oral placebo tablet taken once daily. Days 1 to 3: one placebo tablet. Days 4 to 84: two placebo tablets. On Days 85 participants entered a 7-day Taper Period. Days 85 to 91: one placebo tablet.
496158|NCT00365300|B3|Baseline|Total|Total of all reporting groups
496159|NCT00365300|B2|Baseline|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496160|NCT00365300|B1|Baseline|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496161|NCT00365300|P2|Participant Flow|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496162|NCT00365300|P1|Participant Flow|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496163|NCT00365300|O2|Outcome|Placebo|Double Blind Treatment-withdrawal phase (weeks 5-8): Matching placebo. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496164|NCT00365300|O1|Outcome|Pantoprazole Sodium Granules|Double Blind Treatment-withdrawal phase (weeks 5-8) Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥ 7 kg) in an oral suspension. An Open Label Treatment run-in phase (weeks 1-4) preceded the Double Blind Treatment-withdrawal phase and patients received: Pantoprazole sodium granules at a dose of approximately 1.2 mg/kg daily (5 mg for weight < 7 kg or 10 mg for weight ≥7 kg) in an oral suspension.
496165|NCT00365300|E5|Reported Event|Follow-up|
496166|NCT00365300|E4|Reported Event|Placebo (Double-blind Phase)|
496167|NCT00365300|E3|Reported Event|Pantoprazole Sodium Granules (Double-blind Phase)|
496168|NCT00365300|E2|Reported Event|Pantoprazole Sodium Granules (Open-Label Phase)|
496169|NCT00365300|E1|Reported Event|Screening|
496170|NCT00365274|B1|Baseline|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
496171|NCT00365274|P1|Participant Flow|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
496172|NCT00365274|O1|Outcome|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
496173|NCT00365274|E1|Reported Event|SGN-30 + Combination Chemotherapy|"Monoclonal antibody SGN-30 monotherapy: SGN-30 12 mg/kg weekly intravenously (IV) over 2 hours once weekly for 3 weeks.~SGN-30 and CHOP chemotherapy: Beginning 1 week after completion of monoclonal antibody SGN-30 monotherapy, SGN-30 12 mg/kg IV over 2 hours on day 1 and CHOP chemotherapy comprising cyclophosphamide IV over 1 hour, doxorubicin hydrochloride IV over 15 minutes, and vincristine IV over 15 minutes on day 1 and oral prednisone once daily on days 1-5. Treatment repeats every 21 days for 6-8 courses."
496174|NCT00365261|B3|Baseline|Total|Total of all reporting groups
496175|NCT00365261|B2|Baseline|Placebo|receipt of placebo
496176|NCT00365261|B1|Baseline|Eszopiclone|receipt of active drug
496177|NCT00365261|P2|Participant Flow|Placebo|receipt of placebo
496178|NCT00365261|P1|Participant Flow|Eszopiclone|receipt of active drug
496179|NCT00365261|O2|Outcome|Placebo|placebo
496180|NCT00365261|O1|Outcome|Eszopiclone|active drug
496181|NCT00365261|O2|Outcome|Placebo|"placebo~Placebo: placebo 2 to 3 mg po at bedtime"
496182|NCT00365261|O1|Outcome|Eszopiclone|"active drug~Eszopiclone: eszopiclone 2 to 3 mg po at bedtime"
496183|NCT00365261|O2|Outcome|Placebo|placebo
496184|NCT00365261|O1|Outcome|Eszopiclone|active drug
496185|NCT00365261|E2|Reported Event|Placebo|receipt of placebo
496186|NCT00365261|E1|Reported Event|Eszopiclone|receipt of active drug
496187|NCT00365209|B1|Baseline|Curcumin|"Stage 1: Patients receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Patients receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496226|NCT00365105|P1|Participant Flow|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
496188|NCT00365209|P1|Participant Flow|Curcumin|"Stage 1: Particpants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Particpants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496189|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496190|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496191|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496192|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496193|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496194|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496195|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496196|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496197|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496198|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496199|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496200|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496201|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496202|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496227|NCT00365105|O2|Outcome|Zoledronic Acid + Radopharmaceuticals|Zoledronic acid, vitamin D and calcium supplements, plus Sr-89 or Sm-153.
496228|NCT00365105|O1|Outcome|Zoledronic Acid|Zoledronic acid, vitamin D and calcium supplements.
496203|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496204|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496205|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496206|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496207|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496208|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496209|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496210|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496211|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496212|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496213|NCT00365209|O1|Outcome|Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496214|NCT00365209|E2|Reported Event|Stage2 4 g Curcumin|"Stage 2: Participants receive 4 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496215|NCT00365209|E1|Reported Event|Stage1 2 g Curcumin|"Stage 1: Participants receive 2 grams of oral curcumin once daily. Treatment continues for up to 30 days in the absence of unacceptable toxicity or disease progression.~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~curcumin: Given orally"
496216|NCT00365144|B1|Baseline|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496217|NCT00365144|P1|Participant Flow|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496218|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496219|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496220|NCT00365144|O1|Outcome|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496221|NCT00365144|E1|Reported Event|Bevacizumab Plus Erlotinib|Patients received bevacizumab 15 mg/kg as a 60-90 minute infusion every 21 days (representing one treatment cycle) and erlotinib 150 mg by mouth daily
496222|NCT00365105|B3|Baseline|Total|Total of all reporting groups
496231|NCT00365053|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496232|NCT00365053|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496233|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496234|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496235|NCT00365053|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496236|NCT00365053|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV at 1000 mg/m2 over 30 minutes on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
496237|NCT00364286|B1|Baseline|Dasatinib|Dasatinib 50mg Orally twice daily.
496238|NCT00364286|P1|Participant Flow|Dasatinib|Dasatinib 50mg Orally twice daily.
496239|NCT00364286|O1|Outcome|Dasatinib|Dasatinib 50mg Orally twice daily.
496240|NCT00364286|E1|Reported Event|Dasatinib|Dasatinib 50mg Orally twice daily.
496241|NCT00364182|B4|Baseline|Total|Total of all reporting groups
496242|NCT00364182|B3|Baseline|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
496243|NCT00364182|B2|Baseline|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
496244|NCT00364182|B1|Baseline|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
496245|NCT00364182|P3|Participant Flow|BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
496246|NCT00364182|P2|Participant Flow|BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg|BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion.
496247|NCT00364182|P1|Participant Flow|Pre-Randomization|Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized.
496248|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496249|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496250|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496251|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496252|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496253|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496254|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496255|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496256|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496257|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496258|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496259|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496260|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496261|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496262|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496263|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496264|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496265|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496266|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496267|NCT00364182|O4|Outcome|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496268|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496269|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496270|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496271|NCT00364182|O3|Outcome|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496272|NCT00364182|O2|Outcome|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496273|NCT00364182|O1|Outcome|BeneFIX OD1|BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
496274|NCT00364182|E4|Reported Event|BeneFIX OD2|BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
496275|NCT00364182|E3|Reported Event|BeneFIX 50 IU/kg|BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
496276|NCT00364182|E2|Reported Event|BeneFIX 100 IU/kg|BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
496277|NCT00364182|E1|Reported Event|BeneFIX OD1|BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention)
496278|NCT00364156|B3|Baseline|Total|Total of all reporting groups
496279|NCT00364156|B2|Baseline|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
496280|NCT00364156|B1|Baseline|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
496281|NCT00364156|P2|Participant Flow|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
496282|NCT00364156|P1|Participant Flow|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
496283|NCT00364156|O2|Outcome|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
496284|NCT00364156|O1|Outcome|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
496285|NCT00364156|E2|Reported Event|Standard Patch Treatment|Participants receive 8 weeks of 21 mg nicotine patch followed by 16 weeks of placebo patch.
496286|NCT00364156|E1|Reported Event|Extended Patch Treatment|Participants in this treatment arm receive 24 weeks of 21 mg nicotine patch in addition to 8 smoking cessation counseling sessions.
496287|NCT00364949|B3|Baseline|Total|Total of all reporting groups
496288|NCT00364949|B2|Baseline|PCOS|Polycystic Ovary Syndrome
496289|NCT00364949|B1|Baseline|Control|Control
496290|NCT00364949|P2|Participant Flow|PCOS|Polycystic Ovary Syndrome
496291|NCT00364949|P1|Participant Flow|Control|Control
496292|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496293|NCT00364949|O1|Outcome|Control|Control
496294|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496295|NCT00364949|O1|Outcome|Control|Control
496296|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496297|NCT00364949|O1|Outcome|Control|Control
496298|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496299|NCT00364949|O1|Outcome|Control|Control
496300|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496301|NCT00364949|O1|Outcome|Control|Control
496302|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496303|NCT00364949|O1|Outcome|Control|Control
496304|NCT00364949|O2|Outcome|PCOS|Polycystic Ovary Syndrome
496305|NCT00364949|O1|Outcome|Control|Control
496306|NCT00364949|E2|Reported Event|PCOS|Polycystic Ovary Syndrome
496307|NCT00364949|E1|Reported Event|Control|Control
496308|NCT00364923|B1|Baseline|Full Population|All patients who received at least one dose of pralatrexate
496309|NCT00364923|P1|Participant Flow|Full Population|All patients who received at least one dose of pralatrexate. Patients continued pralatrexate until protocol defined criteria for discontinuation or 24 months of treatment.
496310|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
496311|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
496312|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
496313|NCT00364923|O1|Outcome|Evaluable Population|All patients who received at least one dose of pralatrexate and had an eligible PTCL histopathological subtype confirmed by central pathology review.
496314|NCT00364923|E1|Reported Event|Full Population|All patients who received at least one dose of pralatrexate
496315|NCT00364858|B3|Baseline|Total|Total of all reporting groups
496316|NCT00364858|B2|Baseline|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496317|NCT00364858|B1|Baseline|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496318|NCT00364858|P2|Participant Flow|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496319|NCT00364858|P1|Participant Flow|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496320|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496321|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496322|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496323|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496324|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496325|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496326|NCT00364858|O2|Outcome|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496327|NCT00364858|O1|Outcome|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496328|NCT00364858|E3|Reported Event|Total|
496329|NCT00364858|E2|Reported Event|Q4 Cerezyme|Patients receiving Cerezyme one infusion every 4 weeks(Q4).
496330|NCT00364858|E1|Reported Event|Q2 Cerezyme|Patients receiving Cerezyme one infusion every 2 weeks (Q2).
496331|NCT00364845|B3|Baseline|Total|Total of all reporting groups
496332|NCT00364845|B2|Baseline|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
503629|NCT00339833|P2|Participant Flow|Placebo|Placebo for 7 days.
496333|NCT00364845|B1|Baseline|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496334|NCT00364845|P2|Participant Flow|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496335|NCT00364845|P1|Participant Flow|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496336|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496337|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496338|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496339|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496340|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496341|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496342|NCT00364845|O2|Outcome|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496343|NCT00364845|O1|Outcome|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496344|NCT00364845|E2|Reported Event|Placebo|Single-blind placebo administered by subcutaneous injection (SC) every other week until week 16, then every month for up to 9 months.
496345|NCT00364845|E1|Reported Event|Darbepoetin Alfa|Single-blind darbepoetin alfa administered by subcutaneous injection (SC) every other week until hemoglobin (Hgb) was stable (2 consecutive Hgb values between 120 and 135 g/L), then every month for up to 9 months.
496346|NCT00364832|B10|Baseline|Total|Total of all reporting groups
496347|NCT00364832|B9|Baseline|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496348|NCT00364832|B8|Baseline|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496349|NCT00364832|B7|Baseline|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496350|NCT00364832|B6|Baseline|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496351|NCT00364832|B5|Baseline|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496352|NCT00364832|B4|Baseline|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496353|NCT00364832|B3|Baseline|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496354|NCT00364832|B2|Baseline|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496355|NCT00364832|B1|Baseline|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496356|NCT00364832|P12|Participant Flow|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered SC RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
497604|NCT00361270|P2|Participant Flow|Hypnosis-Practice 8|8 sessions hypnosis with practice cds
496357|NCT00364832|P11|Participant Flow|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered SC RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496358|NCT00364832|P10|Participant Flow|RO0503821 (1x/ Week)|Eligible participants were administered SC RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kilogram of the previous weekly ESA dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496359|NCT00364832|P9|Participant Flow|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496360|NCT00364832|P8|Participant Flow|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496361|NCT00364832|P7|Participant Flow|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496362|NCT00364832|P6|Participant Flow|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496363|NCT00364832|P5|Participant Flow|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496364|NCT00364832|P4|Participant Flow|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496365|NCT00364832|P3|Participant Flow|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496366|NCT00364832|P2|Participant Flow|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496367|NCT00364832|P1|Participant Flow|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) subcutaneous (SC) using a dose conversion factor of 0.4/150 microgram (mcg)/ kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496368|NCT00364832|O3|Outcome|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496369|NCT00364832|O2|Outcome|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496370|NCT00364832|O1|Outcome|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496371|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496565|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496372|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496373|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496374|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496375|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496376|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496377|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496378|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496379|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496380|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496381|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496382|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496383|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496384|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496385|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496386|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496387|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496388|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496389|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496610|NCT00364533|E2|Reported Event|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
505172|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
496390|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496391|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496392|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496393|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496394|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496395|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496396|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496397|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496398|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496399|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496400|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496401|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496402|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496403|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496404|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496405|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496406|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496407|NCT00364832|O9|Outcome|Cohort I (1.2/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496611|NCT00364533|E1|Reported Event|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496612|NCT00364377|B3|Baseline|Total|Total of all reporting groups
496408|NCT00364832|O8|Outcome|Cohort H (1.2/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496409|NCT00364832|O7|Outcome|Cohort G (1.2/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 1.2/150 mcg/kg of the previous weekly ESA dose, (equal to 150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496410|NCT00364832|O6|Outcome|Cohort F (0.8/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496411|NCT00364832|O5|Outcome|Cohort E (0.8/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496412|NCT00364832|O4|Outcome|Cohort D (0.8/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.8/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496413|NCT00364832|O3|Outcome|Cohort C (0.4/150, 1x/ 4 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every four weeks up to 21 weeks. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496414|NCT00364832|O2|Outcome|Cohort B (0.4/150, 1x/ 3 Weeks)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once every three weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496415|NCT00364832|O1|Outcome|Cohort A (0.4/150, 1x/ Week)|Eligible participants were administered RO0503821 SC using a dose conversion factor of 0.4/150 mcg/kg of the previous weekly ESA dose, (equal to 50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496416|NCT00364832|E3|Reported Event|RO0503821 (1x/ 4 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every four weeks (1x/ 4 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort C, Cohort F, and Cohort I, respectively for 21 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 21 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496417|NCT00364832|E2|Reported Event|RO0503821 (1x/ 3 Weeks)|Eligible participants were administered subcutaneous (SC) RO0503821 once every three weeks (1x/ 3 weeks) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 mcg/kg of the previous weekly ESA dose in Cohort B, Cohort E, and Cohort H, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496418|NCT00364832|E1|Reported Event|RO0503821 (1x/ Week)|Eligible participants were administered subcutaneous (SC) RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.4/150-, 0.8/150-, and 1.2/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort A, Cohort D, and Cohort G, respectively for 19 weeks. The ESA dose 50%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.4/150, 0.8/150 and 1.2/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
496419|NCT00364793|B5|Baseline|Total|Total of all reporting groups
496420|NCT00364793|B4|Baseline|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496421|NCT00364793|B3|Baseline|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496422|NCT00364793|B2|Baseline|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496566|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
497605|NCT00361270|P1|Participant Flow|Hypnosis-8|8 sessions of hypnosis with no practice cds
496423|NCT00364793|B1|Baseline|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496424|NCT00364793|P4|Participant Flow|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496425|NCT00364793|P3|Participant Flow|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496426|NCT00364793|P2|Participant Flow|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496427|NCT00364793|P1|Participant Flow|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and emtricitabine (FTC) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496428|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496429|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496430|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496431|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496432|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496604|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
497606|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback no recordings
496433|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496434|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496435|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496436|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496437|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496438|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496439|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496440|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496441|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496442|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496443|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496444|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496445|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496446|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496447|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496448|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496449|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496450|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496451|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496452|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496453|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496482|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
508745|NCT00325897|E2|Reported Event|Placebo|Inactive sugar pill
496454|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496455|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496456|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496457|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496458|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496459|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496460|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496461|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496462|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496605|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496606|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496463|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496464|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496465|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496466|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496467|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496468|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496469|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496470|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496471|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496607|NCT00364533|E5|Reported Event|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
497676|NCT00361257|E1|Reported Event|Minocycline|100 mg orally every 12 hours
496472|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL); participants unable to meet the desired exposures using the oral solution, or those not able to tolerate the oral solution, used the capsule contents sprinkled on food. In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496473|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496474|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496475|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496476|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496477|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496478|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496479|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496480|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496481|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496563|NCT00364611|P2|Participant Flow|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496608|NCT00364533|E4|Reported Event|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496609|NCT00364533|E3|Reported Event|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496483|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496484|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496485|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496486|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496487|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496488|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496489|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496490|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496491|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496492|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496493|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496494|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496495|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496496|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496497|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496498|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496499|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496500|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496501|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496502|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496503|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496504|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
498305|NCT00359801|E1|Reported Event|Exubera®|Exubera® plus usual diabetes care
496505|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496506|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496507|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496508|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496509|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496510|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496511|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496512|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496513|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496514|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496515|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496564|NCT00364611|P1|Participant Flow|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496516|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496517|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496518|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496519|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496520|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496521|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496522|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496523|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496524|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496525|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496526|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
498306|NCT00359788|B3|Baseline|Total|Total of all reporting groups
496527|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496528|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496529|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496530|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496531|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496532|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496533|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496534|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496535|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496536|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496537|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
498307|NCT00359788|B2|Baseline|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
496538|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496539|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496540|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496541|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496542|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496543|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496544|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496545|NCT00364793|O5|Outcome|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496546|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496547|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496548|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
498308|NCT00359788|B1|Baseline|Tiotropium|18 mcg once daily
496549|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496550|NCT00364793|O5|Outcome|Total Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years.
496551|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496552|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496553|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496554|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496555|NCT00364793|O4|Outcome|EFV+ddI+FTC in Children >= 3 Years to <= 6 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496556|NCT00364793|O3|Outcome|EFV+ddI+FTC in Children >= 2 Years to < 3 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496557|NCT00364793|O2|Outcome|EFV+ddI+FTC in Infants >=6 Months to < 2 Years|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496558|NCT00364793|O1|Outcome|EFV+ddI+FTC in Infants >=3 Months to < 6 Months|EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496559|NCT00364793|E1|Reported Event|EFV+ddI+FTC in All Participants|All participants across all age groups, ie greater than, equal to 3 months to less than, equal to 6 years who received study drug. EFV (efavirenz) was administered in accordance with weight-based dosing nomograms and included one of the following preparations in a once a day (QD) dose: EFV capsules (50 and 200 mg) contents mixed with formula or a small amount of food vehicle (eg, yogurt, applesauce, or grape jelly), or oral solution (30 mg/mL). In addition, the following 2 drugs were administered: ddI (didanosine) (Pediatric Powder for Oral Solution or capsules of enteric-coated beads): 240 mg/m^2 QD; maximum daily dose of 400 mg and FTC (emtricitabine) (solution or tablets) 6 mg/kg QD; maximum daily dose of 240 mg.
496560|NCT00364611|B3|Baseline|Total|Total of all reporting groups
496561|NCT00364611|B2|Baseline|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496562|NCT00364611|B1|Baseline|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496567|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496568|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496569|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496570|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496571|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496572|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496573|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496574|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496575|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496576|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496577|NCT00364611|O2|Outcome|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496578|NCT00364611|O1|Outcome|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496579|NCT00364611|E2|Reported Event|Docetaxel, Bevacizumab and Trastuzumab|Stratum 2: HER2 Positive participants with metastatic breast cancer treated with DBT (docetaxel, bevacizumab, and trastuzumab) IV q3w until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496580|NCT00364611|E1|Reported Event|Docetaxel and Bevacizumab|Stratum 1: HER2 Negative participants with metastatic breast cancer treated with DB (docetaxel and bevacizumab) intravenously (IV) every 3 weeks (q3w) until treatment discontinuation criteria (unacceptable toxicity, disease progression or death) are met
496581|NCT00364533|B6|Baseline|Total|Total of all reporting groups
496582|NCT00364533|B5|Baseline|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
496583|NCT00364533|B4|Baseline|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496584|NCT00364533|B3|Baseline|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496585|NCT00364533|B2|Baseline|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496586|NCT00364533|B1|Baseline|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496587|NCT00364533|P5|Participant Flow|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
496588|NCT00364533|P4|Participant Flow|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496589|NCT00364533|P3|Participant Flow|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496590|NCT00364533|P2|Participant Flow|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496591|NCT00364533|P1|Participant Flow|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496592|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
496593|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496594|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496595|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496596|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496597|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
496598|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496599|NCT00364533|O3|Outcome|Tapentadol IR Fixed Dose 100 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496600|NCT00364533|O2|Outcome|Tapentadol IR Fixed Dose 75 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496601|NCT00364533|O1|Outcome|Tapentadol IR Fixed Dose 50 mg|Tapentadol taken by mouth every 4-6 hours for 3 days
496602|NCT00364533|O5|Outcome|Placebo Fixed Dose|Matching placebo taken by mouth every 4-6 hours for 3 days
496603|NCT00364533|O4|Outcome|Oxycodone HCL IR Fixed Dose 10 mg|oxycodone 10mg taken by mouth every 4-6 hours for 3 days
496613|NCT00364377|B2|Baseline|Placebo|People with impaired fasting glucose treated with placebo once daily.
496614|NCT00364377|B1|Baseline|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
496615|NCT00364377|P2|Participant Flow|Placebo|People with impaired fasting glucose treated with placebo once daily.
496616|NCT00364377|P1|Participant Flow|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
496617|NCT00364377|O2|Outcome|Placebo|People with impaired fasting glucose treated with placebo once daily.
496618|NCT00364377|O1|Outcome|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
496619|NCT00364377|E2|Reported Event|Placebo|People with impaired fasting glucose treated with placebo once daily.
496620|NCT00364377|E1|Reported Event|Sitagliptin|People with impaired fasting glucose treated with sitagliptin 100mg once daily.
496621|NCT00364351|B3|Baseline|Total|Total of all reporting groups
496622|NCT00364351|B2|Baseline|Erlotinib|Erlotinib
496623|NCT00364351|B1|Baseline|Vandetanib|Vandetanib 300 mg
496624|NCT00364351|P2|Participant Flow|Erlotinib|Erlotinib 150 mg tablet taken once daily plus a placebo for vandetanib
496625|NCT00364351|P1|Participant Flow|Vandetanib|Vandetanib 300 mg tablet taken once daily plus a placebo for erlotinib
496626|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496627|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496628|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496629|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496630|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496631|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496632|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496633|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496634|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496635|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496636|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496637|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496638|NCT00364351|O2|Outcome|Erlotinib|Erlotinib
496639|NCT00364351|O1|Outcome|Vandetanib|Vandetanib 300 mg
496640|NCT00364351|E2|Reported Event|Erlotinib|Erlotinib
496641|NCT00364351|E1|Reported Event|Vandetanib|Vandetanib 300 mg
496642|NCT00364130|B3|Baseline|Total|Total of all reporting groups
496643|NCT00364130|B2|Baseline|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496644|NCT00364130|B1|Baseline|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496645|NCT00364130|P2|Participant Flow|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496646|NCT00364130|P1|Participant Flow|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496647|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496648|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496649|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496650|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496651|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496652|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496653|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496654|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496655|NCT00364130|O2|Outcome|Inactive Low Magnitude Mechanical Stimulus|"Inactive, or placebo low magnitude mechanical stimulus~Placebo (inactive) low magnitude mechanical stimulus: 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device"
496656|NCT00364130|O1|Outcome|Active Low Magnitude Mechanical Stimulus|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus: 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496657|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496658|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496659|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496660|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496661|NCT00364130|O2|Outcome|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496662|NCT00364130|O1|Outcome|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496663|NCT00364130|E2|Reported Event|Pacebo|Placebo (inactive) low magnitude mechanical stimulus : 10 minute daily treatments standing on a placebo version of a low magnitude mechanical stimulus device
496664|NCT00364130|E1|Reported Event|Active|"Active Low Magnitude Mechanical Stimulus~Low magnitude mechanical stimulus : 10 minute daily treatment sessions standing on the low magnitude mechanical stimulus device"
496665|NCT00364013|B3|Baseline|Total|Total of all reporting groups
496666|NCT00364013|B2|Baseline|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496667|NCT00364013|B1|Baseline|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496668|NCT00364013|P2|Participant Flow|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496669|NCT00364013|P1|Participant Flow|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496670|NCT00364013|O2|Outcome|FOLFOX Alone|Participants were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496671|NCT00364013|O1|Outcome|FOLFOX + Panitumumab|Participants were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496672|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496673|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496674|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496675|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496676|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496677|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496678|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496679|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496680|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496681|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496682|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496683|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496684|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496685|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496686|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496687|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496688|NCT00364013|O4|Outcome|Mutant KRAS - FOLFOX|Participants with mutant KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496689|NCT00364013|O3|Outcome|Mutant KRAS - FOLFOX + Panitumumab|Participants with mutant KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496690|NCT00364013|O2|Outcome|Wild-type KRAS - FOLFOX|Participants with wild-type KRAS were randomized to FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496691|NCT00364013|O1|Outcome|Wild-type KRAS - FOLFOX + Panitumumab|Participants with wild-type KRAS were randomized to panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496692|NCT00364013|E2|Reported Event|FOLFOX Alone|Participants received FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or until unacceptable toxicity.
496693|NCT00364013|E1|Reported Event|Panitumumab Plus FOLFOX|Participants received panitumumab, 6 mg/kg on Day 1 and FOLFOX chemotherapy regimen on Days 1 and 2 of each 14-day cycle until disease progression or unacceptable toxicity.
496694|NCT00363896|B3|Baseline|Total|Total of all reporting groups
496695|NCT00363896|B2|Baseline|Placebo|Placebo by inhalation
496696|NCT00363896|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
496697|NCT00363896|P2|Participant Flow|Placebo|Placebo by inhalation
496698|NCT00363896|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
496699|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
496700|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
496701|NCT00363896|O2|Outcome|Placebo|Placebo by inhalation
496702|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
496703|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
496704|NCT00363896|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
496705|NCT00363896|O2|Outcome|Placebo|Placebo once-daily via inhalation
496706|NCT00363896|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily via inhalation
496707|NCT00363896|E2|Reported Event|Placebo|Placebo by inhalation
496708|NCT00363896|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
496709|NCT00363883|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496710|NCT00363883|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496711|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496712|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496713|NCT00363883|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496714|NCT00363883|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) twice daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~laboratory biomarker analysis: Correlative studies"
496715|NCT00363805|B4|Baseline|Total|Total of all reporting groups
496716|NCT00363805|B3|Baseline|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
496717|NCT00363805|B2|Baseline|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
496718|NCT00363805|B1|Baseline|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
496719|NCT00363805|P3|Participant Flow|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
496720|NCT00363805|P2|Participant Flow|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
496721|NCT00363805|P1|Participant Flow|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
496722|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
496723|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
496724|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
496725|NCT00363805|O3|Outcome|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
496726|NCT00363805|O2|Outcome|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
496727|NCT00363805|O1|Outcome|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
496728|NCT00363805|E3|Reported Event|Placebo|Patients receive placebo beverage and placebo capsules daily for 6 months.
496729|NCT00363805|E2|Reported Event|Polyphenon E|Patients receive placebo beverage and Polyphenon E capsules daily for 6 months.
496730|NCT00363805|E1|Reported Event|Green Tea|Patients receive green tea beverage and placebo capsules for 6 months.
496731|NCT00363779|B1|Baseline|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
496732|NCT00363779|P1|Participant Flow|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
496733|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
496734|NCT00363779|O1|Outcome|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
496735|NCT00363779|E1|Reported Event|LGL Patients Administered Cyclosporine|Large Granular Lymphocyte Leukemia (LGL) is a low grade non-Hodgkins lymphoma characterized by tissue invasion of the marrow, spleen, and liver. Cyclosporine 5-10 mg/kg/day was administered as an oral preparation given every 12 hours. Doses are adjusted to maintain a therapeutic level between 200-400 ng/ml.
496736|NCT00363675|B1|Baseline|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496737|NCT00363675|P1|Participant Flow|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496738|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496739|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496740|NCT00363675|O1|Outcome|Normal as Defined by Hand Therapist.|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496741|NCT00363675|O1|Outcome|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496742|NCT00363675|E1|Reported Event|All Study Participants|Children were administered hand assessments to measure function after hand burns by a trained therapist.
496743|NCT00363467|B1|Baseline|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496744|NCT00363467|P1|Participant Flow|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496745|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496746|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496747|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496748|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496749|NCT00363467|O1|Outcome|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496750|NCT00363467|E1|Reported Event|Autologous Hematopoietic Progenitor Cell Transplantation|G-CSF Mobilization Leukepheresis Busulfan Stem Cell Reinfusion
496751|NCT00363415|B3|Baseline|Total|Total of all reporting groups
496752|NCT00363415|B2|Baseline|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496753|NCT00363415|B1|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496754|NCT00363415|P2|Participant Flow|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496755|NCT00363415|P1|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496756|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496757|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496758|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496759|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496760|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496761|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496762|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496763|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496764|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496765|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496766|NCT00363415|O2|Outcome|Etoposide + Carboplatin|Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496767|NCT00363415|O1|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles
496768|NCT00363415|E2|Reported Event|Etoposide + Carboplatin|"Etoposide: 100 mg/m2, intravenous (IV), days 1-3 x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles.~(Participants who received at least one dose of study drug)"
496769|NCT00363415|E1|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles (Participants who received at least one dose of study drug)
496770|NCT00363311|B3|Baseline|Total|Total of all reporting groups
496771|NCT00363311|B2|Baseline|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496772|NCT00363311|B1|Baseline|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496773|NCT00363311|P2|Participant Flow|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496774|NCT00363311|P1|Participant Flow|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 milligrams (mg) administered orally once daily for 156 weeks
496775|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
508746|NCT00325897|E1|Reported Event|Azithromycin|Azithromycin, 250 mg
496776|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496777|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496778|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496779|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496780|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496781|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496782|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496783|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496784|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496785|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496786|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496787|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496788|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496789|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496790|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496791|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496792|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496793|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496794|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496795|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496796|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496797|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496798|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496799|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496800|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496801|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496802|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496803|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496804|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496805|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496806|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496807|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496808|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496809|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496810|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496811|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496812|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496813|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496814|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496815|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496816|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496817|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496818|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496819|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496820|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496821|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496822|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496823|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496824|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496825|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496826|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496827|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496828|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496829|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496830|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496831|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496832|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496833|NCT00363311|O2|Outcome|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496834|NCT00363311|O1|Outcome|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496835|NCT00363311|E2|Reported Event|Dutasteride 0.5 mg Once Daily|Dutasteride 0.5 mg administered orally once daily for 156 weeks
496836|NCT00363311|E1|Reported Event|Matching Placebo 0.5 mg Once Daily|Matching placebo 0.5 mg administered orally once daily for 156 weeks
496837|NCT00363246|B1|Baseline|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
496838|NCT00363246|P1|Participant Flow|Group 1|Older veterans who use a wheelchair for their primary means of mobility.
496839|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older Veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
496840|NCT00363246|O1|Outcome|Wheelchair-using Veterans|Older veterans who use a wheelchair for their primary means of mobility. 1 year follow-up period.
496841|NCT00363246|E1|Reported Event|Elderly Veterans Using Wheelchairs for Mobility|Older veterans who use a wheelchair for their primary means of mobility. This was an observational study. There was no intervention and thus no adverse events were collected as part of the study. Sometimes we learned of a death from a relative when we called monthly.
496842|NCT00363168|B3|Baseline|Total|Total of all reporting groups
496843|NCT00363168|B2|Baseline|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
496844|NCT00363168|B1|Baseline|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
496845|NCT00363168|P2|Participant Flow|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
496846|NCT00363168|P1|Participant Flow|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
496847|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
496848|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
496849|NCT00363168|O2|Outcome|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
496850|NCT00363168|O1|Outcome|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
496851|NCT00363168|E2|Reported Event|Ranibizumab Dose B|0.5 mg/0.05 ml intravitreal injection
496852|NCT00363168|E1|Reported Event|Ranibizumab Dose A|0.3 mg/0.05 ml intravitreal injection
496853|NCT00363142|B3|Baseline|Total|Total of all reporting groups
496854|NCT00363142|B2|Baseline|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496855|NCT00363142|B1|Baseline|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496856|NCT00363142|P2|Participant Flow|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496857|NCT00363142|P1|Participant Flow|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496858|NCT00363142|O3|Outcome|FPV/RTV 700/100 mg BID|Twice daily FPV regimen boosted with a reduced dose of RTV 100 mg
496859|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700/100mg twice a day [BID] or 1400/200mg QD)
496860|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400/100mg once a day (QD)
496861|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496862|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496863|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496864|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496865|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496866|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496867|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496868|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496869|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496870|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496871|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496872|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496873|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496874|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496875|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496876|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496877|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496878|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496879|NCT00363142|O2|Outcome|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496880|NCT00363142|O1|Outcome|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496881|NCT00363142|E2|Reported Event|FPV/r200|FPV/RTV (either 700mg/100mg twice a day [BID] or 1400mg/200mg QD)
496882|NCT00363142|E1|Reported Event|FPV/r100|Fosamprenavir (FPV)/ritonavir (RTV) 1400mg/100mg once a day (QD)
496883|NCT00363129|B3|Baseline|Total|Total of all reporting groups
497270|NCT00362128|O1|Outcome|Observational|The study design was a cross-sectional observational cohort design.
496884|NCT00363129|B2|Baseline|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496885|NCT00363129|B1|Baseline|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496886|NCT00363129|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496887|NCT00363129|P1|Participant Flow|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496888|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496889|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496890|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496891|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496892|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496893|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496894|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496895|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496896|NCT00363129|O2|Outcome|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496897|NCT00363129|O1|Outcome|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496898|NCT00363129|E2|Reported Event|Placebo|Patients receive oral placebo twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496899|NCT00363129|E1|Reported Event|Vitamin E|Patients receive oral vitamin E twice daily beginning within 4 days of the start of chemotherapy course 1 and continuing until 1 month after completion of chemotherapy.
496900|NCT00363077|B3|Baseline|Total|Total of all reporting groups
496901|NCT00363077|B2|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496902|NCT00363077|B1|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496903|NCT00363077|P2|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496904|NCT00363077|P1|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496905|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496906|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496907|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496908|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496909|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496910|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496911|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496912|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496913|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496914|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
497003|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
496915|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496916|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496917|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496918|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496919|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496920|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496921|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496922|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496923|NCT00363077|O2|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496924|NCT00363077|O1|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496925|NCT00363077|E2|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Fluarix™ vaccine. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496926|NCT00363077|E1|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of the GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
496927|NCT00363051|B3|Baseline|Total|Total of all reporting groups
496928|NCT00363051|B2|Baseline|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
496929|NCT00363051|B1|Baseline|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496930|NCT00363051|P2|Participant Flow|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496931|NCT00363051|P1|Participant Flow|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496932|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496933|NCT00363051|O2|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496934|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496935|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496936|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
497004|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
496937|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
496938|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496939|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
496940|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496941|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496942|NCT00363051|O1|Outcome|Stratum 2: Everolimus 10 mg + Octreotide Depot|"Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.~Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day."
496943|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496944|NCT00363051|O1|Outcome|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496945|NCT00363051|E2|Reported Event|Stratum 2: Everolimus 10 mg + Octreotide Depot|Stratum 2 participants who had received at least three consecutive months of Octreotide Long Acting Depot therapy prior to enrollment. These patients also received Everolimus 10 mg/day in addition to continuing their entry dose of Octreotide Depot.
496946|NCT00363051|E1|Reported Event|Stratum 1: Everolimus 10 mg|Stratum 1 patients who were not receiving regular Octreotide Depot therapy. These patients were to receive everolimus monotherapy at 10 mg/day. Patients were instructed to take two 5 mg tablets of everolimus orally with a glass of water, once daily (preferably in the morning). Dosing was strongly recommended to occur at the same time every day.
496947|NCT00363038|B1|Baseline|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
496948|NCT00363038|P1|Participant Flow|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum United States Pharmacopeia (USP) as placebo.
496949|NCT00363038|O1|Outcome|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
496950|NCT00363038|E1|Reported Event|Average Bruise Improvement|pulsed dye laser induced four 1 cm bruises at least 5 cm apart on the skin of the upper arm (two bruises on each arm). Subjects applied different topical ointments on each of their bruises twice a day. Ointments were: 5% vitamin K cream; 1% vitamin K and 0.3% retinol cream; 20% topical arnica; white petrolatum USP as placebo.
496951|NCT00362882|B3|Baseline|Total|Total of all reporting groups
496952|NCT00362882|B2|Baseline|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496953|NCT00362882|B1|Baseline|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496954|NCT00362882|P2|Participant Flow|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496955|NCT00362882|P1|Participant Flow|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
497005|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
498309|NCT00359788|P2|Participant Flow|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
496956|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496957|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496958|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496959|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496960|NCT00362882|O2|Outcome|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496961|NCT00362882|O1|Outcome|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496962|NCT00362882|E2|Reported Event|Arm 2|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 2 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496963|NCT00362882|E1|Reported Event|Arm 1|"Patients receive docetaxel IV at 75 mg/m2 on day 1 and bortezomib IV at 1.6 mg/m2 seconds on days 1 and 8.~docetaxel: Given IV~bortezomib: Given IV~laboratory biomarker analysis: correlative study~immunoenzyme technique: correlative study~immunohistochemistry staining method: correlative study~pharmacological study: correlative study"
496964|NCT00362817|B1|Baseline|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496965|NCT00362817|P1|Participant Flow|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496966|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496967|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496968|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496969|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~carboplatin: IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2.~temozolomide: 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks."
496970|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496971|NCT00362817|O1|Outcome|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496972|NCT00362817|E1|Reported Event|Temozolomide & Intra-Arterial (IA) Carboplatin|"Patients will be administered Temozolomide orally once a day for 5 consecutive days and and will receive Intra Arterial Carboplatin~temozolomide : 150 mg/m2/day orally Days 1-5. Treatment cycles to be repeated every 4 weeks.~carboplatin : IA carboplatin 200 mg/m2/day for each arterial injection on days 1 and 2."
496973|NCT00362648|B5|Baseline|Total|Total of all reporting groups
496974|NCT00362648|B4|Baseline|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496975|NCT00362648|B3|Baseline|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496976|NCT00362648|B2|Baseline|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496977|NCT00362648|B1|Baseline|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496978|NCT00362648|P4|Participant Flow|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496979|NCT00362648|P3|Participant Flow|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496980|NCT00362648|P2|Participant Flow|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496981|NCT00362648|P1|Participant Flow|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496982|NCT00362648|O2|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496983|NCT00362648|O1|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496984|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496985|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496986|NCT00362648|O4|Outcome|Placebo - Asia|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496987|NCT00362648|O3|Outcome|RotaTeq™ - Asia|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496988|NCT00362648|O2|Outcome|Placebo - Africa|Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496989|NCT00362648|O1|Outcome|RotaTeq™ - Africa|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.
496990|NCT00362648|E6|Reported Event|Placebo - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
496991|NCT00362648|E5|Reported Event|RotaTeq™ - Kenya Safety Cohort|A subset of subjects (Kenya Safety Cohort, N=301), were followed for all Other Adverse Events and SAEs occurring within 42 days following any vaccination.
496992|NCT00362648|E4|Reported Event|Placebo, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
496993|NCT00362648|E3|Reported Event|RotaTeq™, Placebo, RotaTeq™|"Includes SAE data for subjects who were cross-treated, ie; received a treatment other than what they were assigned.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination."
496994|NCT00362648|E2|Reported Event|Placebo|"Three doses of Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~SAEs were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
496995|NCT00362648|E1|Reported Event|RotaTeq™|"Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 14 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) until the end of the study.~Serious clinical adverse experiences (SAE) were recorded for all randomized subjects for 14 days following any vaccination and are reported by treatment group (including cross treated subjects) and are not reported by Region (Africa and Asia).~Other Adverse Events were recorded for a subset of subjects (Kenya Safety Cohort, N=301), who were followed for all non-serious and serious adverse experiences occurring within 42 days following any vaccination."
496996|NCT00362609|B3|Baseline|Total|Total of all reporting groups
496997|NCT00362609|B2|Baseline|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
496998|NCT00362609|B1|Baseline|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
496999|NCT00362609|P2|Participant Flow|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
497000|NCT00362609|P1|Participant Flow|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
497001|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
497002|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
497006|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
497007|NCT00362609|O2|Outcome|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
497008|NCT00362609|O1|Outcome|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
497009|NCT00362609|E2|Reported Event|2.5 mg Pantoprazole|2.5 mg of pantoprazole granules daily for at least 5 days. This dose corresponds to approximately 1.2 mg/kg
497010|NCT00362609|E1|Reported Event|1.25 mg Pantoprazole|1.25 mg of pantoprazole granules daily for at least 5 days. This dosing corresponds to approximately 0.6 mg/kg
497011|NCT00362466|B3|Baseline|Total|Total of all reporting groups
497012|NCT00362466|B2|Baseline|Imatinib|600 mg QD
497013|NCT00362466|B1|Baseline|Dasatinib|100 mg QD
497014|NCT00362466|P2|Participant Flow|Imatinib|600 mg QD
497015|NCT00362466|P1|Participant Flow|Dasatinib|100 mg once daily (QD)
497016|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497017|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497018|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497019|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497020|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497021|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497022|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497023|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497024|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497025|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497026|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497027|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497028|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497029|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497030|NCT00362466|O2|Outcome|Imatinib|600 mg QD
497031|NCT00362466|O1|Outcome|Dasatinib|100 mg QD
497032|NCT00362466|E2|Reported Event|Imatinib|600 mg QD
497033|NCT00362466|E1|Reported Event|Dasatinib|100 mg once daily (QD)
497034|NCT00362453|B3|Baseline|Total|Total of all reporting groups
497035|NCT00362453|B2|Baseline|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497036|NCT00362453|B1|Baseline|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497037|NCT00362453|P2|Participant Flow|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497038|NCT00362453|P1|Participant Flow|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497039|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497040|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497041|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497042|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497043|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497044|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497045|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497046|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497047|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497048|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497049|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497050|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497051|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497052|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497053|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497054|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497055|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497056|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497057|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497058|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497059|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497060|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497061|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497062|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497063|NCT00362453|O2|Outcome|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497064|NCT00362453|O1|Outcome|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497065|NCT00362453|E2|Reported Event|Attention Control|20 participants were randomly assigned to a wellness education and stretching program for the control group, which provided an active control for the attention being paid to the Tai Chi group.
497066|NCT00362453|E1|Reported Event|Tai Chi|20 participants were randomly assigned to practice a Tai Chi program based on the classical Yang Style for 60 minutes, twice a week, over 12 weeks.
497067|NCT00362414|B1|Baseline|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
497068|NCT00362414|P1|Participant Flow|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
497069|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497070|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497071|NCT00362414|O1|Outcome|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
497072|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497073|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497074|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497075|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497076|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497077|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497078|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497079|NCT00362414|O1|Outcome|2 Growth Factors|double growth factors
497080|NCT00362414|O1|Outcome|Two Growth Factors|double growth factors
497081|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
497082|NCT00362414|O1|Outcome|Dual Growth Factor|"All patients received erythropoietin and beta-hCG. This was the only treatment arm in the study, i.e., all enrollees received active therapy.~Dual Growth Factor: 10,000 IU Beta-hCG IV on days 1, 3, and 5 of study participation~30,000 IU Erythropoietin IV on days 7, 8 and 9 of study participation"
497083|NCT00362414|E1|Reported Event|Beta-hCG + Erythropoietin|Subjects received a 9-day course of beta-human chorionic gonadotropin (once daily on Days 1, 3, and 5 of study participation) followed by erythropoietin (once daily on Days 7, 8, and 9 of study participation)
497084|NCT00362401|B4|Baseline|Total|Total of all reporting groups
497085|NCT00362401|B3|Baseline|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497086|NCT00362401|B2|Baseline|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497087|NCT00362401|B1|Baseline|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497088|NCT00362401|P3|Participant Flow|St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497089|NCT00362401|P2|Participant Flow|Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497090|NCT00362401|P1|Participant Flow|ATS (Open Pivot® Standard)|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497091|NCT00362401|O3|Outcome|Group 3 - St Jude Medical|patients with a St Jude Medical mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497111|NCT00362336|B4|Baseline|Total|Total of all reporting groups
497092|NCT00362401|O2|Outcome|Group 2- Medtronic Hall|patients with a Medtronic Hall mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497093|NCT00362401|O1|Outcome|Group 1 - ATS|patients with an ATS mechanical heart valve recruited from a cardiology outpatient clinic following heart valve replacement at the same hospital between three months and four years prior to this investigation.
497094|NCT00362375|B3|Baseline|Total|Total of all reporting groups
497095|NCT00362375|B2|Baseline|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497096|NCT00362375|B1|Baseline|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497097|NCT00362375|P2|Participant Flow|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497098|NCT00362375|P1|Participant Flow|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497099|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497100|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497101|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497102|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497103|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497104|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497105|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497106|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497107|NCT00362375|O2|Outcome|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497108|NCT00362375|O1|Outcome|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497109|NCT00362375|E2|Reported Event|HIV101|The HIV 101 Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to provide factual information regarding HIV/AIDS and sexually transmitted infections.
497110|NCT00362375|E1|Reported Event|Healthy Love Workshop|The Healthy Love Workshop is a single-session intervention lasting 3-4 h that is typically delivered to groups of 4-15 women; however, SisterLove facilitators can accommodate larger groups if needed. The intervention is designed to increase consistent use of condoms and other latex barriers, reduce unprotected sex with male partners, and reduce the number of sex partners. HLW also promotes sexual abstinence, HIV testing, and receipt of test results.
497112|NCT00362336|B3|Baseline|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497113|NCT00362336|B2|Baseline|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497114|NCT00362336|B1|Baseline|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497115|NCT00362336|P3|Participant Flow|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497116|NCT00362336|P2|Participant Flow|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497117|NCT00362336|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497118|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497119|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497120|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497121|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497122|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497123|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497124|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497170|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497125|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497126|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497127|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497128|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497129|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP-T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497130|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP-T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497131|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497132|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497133|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497134|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497135|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497136|NCT00362336|O3|Outcome|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497137|NCT00362336|O2|Outcome|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497138|NCT00362336|O1|Outcome|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497139|NCT00362336|E3|Reported Event|DTaP-IPV-Hep B-PRP~T (Engerix B™ at Birth) Group|Participants received Engerix B™ vaccine at birth, followed by a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular (aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497140|NCT00362336|E2|Reported Event|CombAct-Hib™ + Engerix B™ + OPV Group|Participants received a primary series of 3 doses of commercial CombAct-Hib™ vaccine, Engerix B™ vaccine, and oral poliovirus vaccine, with 1 dose of each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497141|NCT00362336|E1|Reported Event|DTaP-IPV-Hep B-PRP~T Group|Participants received a primary series of 3 doses of diphtheria (D), tetanus (T), pertussis (2 component acellular(aP), recombinant hepatitis B Hansenula (Hep B) and inactivated poliomyelitis vaccine (IPV) adsorbed, and Haemophilus influenzae type b (Hib) vaccine, polyribosyl ribitol phosphate (PRP) conjugated to tetanus protein (DTaP-IPV-Hep B-PRP-T), with 1 dose each at 6, 10, and 14 weeks of age, and a booster dose at 15 to 18 months of age. Participants also received Trimovax™ and Varilrix™ vaccines at 15 to 18 months of age.
497142|NCT00362297|B3|Baseline|Total|Total of all reporting groups
497143|NCT00362297|B2|Baseline|High-dose|
497144|NCT00362297|B1|Baseline|Standard Dose|
497145|NCT00362297|P2|Participant Flow|High-dose|
497146|NCT00362297|P1|Participant Flow|Standard Dose|
497147|NCT00362297|O2|Outcome|High Dose Acyclovir|
497148|NCT00362297|O1|Outcome|Standardy Dose Valacyclovir|
497149|NCT00362297|E2|Reported Event|High-dose|
497150|NCT00362297|E1|Reported Event|Standard Dose|
497151|NCT00362232|B3|Baseline|Total|Total of all reporting groups
497152|NCT00362232|B2|Baseline|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497153|NCT00362232|B1|Baseline|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497154|NCT00362232|P2|Participant Flow|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497155|NCT00362232|P1|Participant Flow|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497156|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497157|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497158|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497159|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497160|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497161|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497162|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497163|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497164|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497165|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497166|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497167|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497168|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497169|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497171|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497172|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497173|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497174|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497175|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497176|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497177|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497178|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497179|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497180|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497181|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497182|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497183|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497184|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497185|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497186|NCT00362232|O2|Outcome|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497187|NCT00362232|O1|Outcome|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497188|NCT00362232|E2|Reported Event|Enoxaparin 30 mg Twice a Day (Bid)|Placebo tablet of rivaroxaban administered once daily in the evening plus syringes of enoxaparin active substance 30 mg twice a day administered once in the morning and once in the evening.
497189|NCT00362232|E1|Reported Event|Rivaroxaban 10 mg Once Daily (OD) (Xarelto, BAY59-7939)|Rivaroxaban (Xarelto, BAY59-7939) 10 mg tablet administered once daily (od) in the evening plus placebo syringes of enoxaparin twice a day (bid) administered once in the morning and once in the evening.
497190|NCT00362180|B10|Baseline|Total|Total of all reporting groups
497191|NCT00362180|B9|Baseline|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497192|NCT00362180|B8|Baseline|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497193|NCT00362180|B7|Baseline|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497194|NCT00362180|B6|Baseline|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497195|NCT00362180|B5|Baseline|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497196|NCT00362180|B4|Baseline|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
497197|NCT00362180|B3|Baseline|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497198|NCT00362180|B2|Baseline|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497199|NCT00362180|B1|Baseline|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497200|NCT00362180|P9|Participant Flow|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497201|NCT00362180|P8|Participant Flow|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497202|NCT00362180|P7|Participant Flow|Cohort F: no Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497203|NCT00362180|P6|Participant Flow|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497204|NCT00362180|P5|Participant Flow|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497205|NCT00362180|P4|Participant Flow|Cohort D: Placebo|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of placebo over the course of 4 weeks.
497206|NCT00362180|P3|Participant Flow|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497207|NCT00362180|P2|Participant Flow|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497208|NCT00362180|P1|Participant Flow|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497209|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497210|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497211|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497212|NCT00362180|O5|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497213|NCT00362180|O4|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497214|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497215|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497216|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497217|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497218|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497219|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497220|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497221|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497222|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497223|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497224|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497225|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497226|NCT00362180|O7|Outcome|Cohort G: Placebo Follwed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497227|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497228|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497229|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497230|NCT00362180|O3|Outcome|Cohort D: Mipomersen|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497231|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497232|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
498310|NCT00359788|P1|Participant Flow|Tiotropium|18 mcg once daily
497233|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497234|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497235|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497236|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497237|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497238|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497239|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497240|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497241|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497242|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497243|NCT00362180|O6|Outcome|Cohort F: No Study Intervention|A reference group of participants with familial hypobetalipoproteinemia (FBHL) who did not receive a study intervention. Data gathered for 15 weeks.
497244|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497245|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497246|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497247|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497248|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497249|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497250|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497251|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
497252|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497253|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497254|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497255|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497256|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497257|NCT00362180|O8|Outcome|Cohort G: Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with mipomersen 200 mg weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497258|NCT00362180|O7|Outcome|Cohort G: Placebo Followed by Mipomersen|Participants with well-controlled Type 2 diabetes mellitus, hypercholesterolemia, and normal triglyceride levels were treated with placebo weekly for 26 weeks, followed by open-label mipomersen 200 mg weekly for an additional 26 weeks.
497259|NCT00362180|O6|Outcome|Cohort F: no Study Intervention|Participants with a diagnosis of Familial Hypobetalipoproteinemia (FHBL) and were not treated with mipomersen or placebo.
497260|NCT00362180|O5|Outcome|Cohort E: Mipomersen|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly mipomersen 200 mg injections for 13 weeks.
497261|NCT00362180|O4|Outcome|Cohort E: Placebo|Participants with uncomplicated heterozygous familial hypercholesterolemia (HeFH) treated with weekly placebo injections for 13 weeks.
497262|NCT00362180|O3|Outcome|Cohort D|Participants with impaired fasting glucose and mixed dyslipidemia who were treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497263|NCT00362180|O2|Outcome|Cohort A: Mipomersen|Healthy volunteers treated with 6 injections of mipomersen 200 mg over the course of 4 weeks.
497264|NCT00362180|O1|Outcome|Cohort A: Placebo|Healthy volunteers treated with 6 injections of placebo over the course of 4 weeks.
497265|NCT00362180|E3|Reported Event|Not Treated|Not Treated
497266|NCT00362180|E2|Reported Event|Mipomersen|Mipomersen
497267|NCT00362180|E1|Reported Event|Placebo|Placebo
497268|NCT00362128|B1|Baseline|Observational|The study design was a cross-sectional observational cohort design.
497269|NCT00362128|P1|Participant Flow|Observational|The study design was a cross-sectional observational cohort design.
497271|NCT00362128|E1|Reported Event|Observational|The study design was a cross-sectional observational cohort design.
497272|NCT00362115|B8|Baseline|Total|Total of all reporting groups
497273|NCT00362115|B7|Baseline|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497274|NCT00362115|B6|Baseline|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497275|NCT00362115|B5|Baseline|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497276|NCT00362115|B4|Baseline|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497277|NCT00362115|B3|Baseline|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497278|NCT00362115|B2|Baseline|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497279|NCT00362115|B1|Baseline|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497280|NCT00362115|P7|Participant Flow|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497281|NCT00362115|P6|Participant Flow|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497282|NCT00362115|P5|Participant Flow|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497283|NCT00362115|P4|Participant Flow|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497284|NCT00362115|P3|Participant Flow|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497285|NCT00362115|P2|Participant Flow|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497286|NCT00362115|P1|Participant Flow|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497287|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497288|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497289|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497290|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497291|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497292|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497293|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497294|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497295|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497296|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497297|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497298|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497299|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497300|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497301|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497302|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497303|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497304|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497305|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497306|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497307|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497308|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497309|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497310|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497311|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497312|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497313|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497314|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497315|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497316|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497317|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497318|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497319|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497320|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497321|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497322|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497323|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497324|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497325|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497326|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497327|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497328|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497329|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497330|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497331|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497332|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497333|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497334|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497335|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497336|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497337|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497338|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497339|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497340|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497341|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497342|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497343|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497344|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497345|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497346|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497347|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497348|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497349|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497350|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497351|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497352|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497353|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497354|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497355|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497356|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497357|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497358|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497359|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497360|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497361|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497362|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497363|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497364|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497365|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497366|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497367|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497368|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497369|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497370|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497371|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497372|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497373|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497374|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497375|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497376|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497377|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497378|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497379|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497380|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497381|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497382|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497383|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497384|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497385|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497386|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497387|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497388|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497389|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497390|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497391|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497392|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497393|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497394|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497395|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497396|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497397|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497398|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497399|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497400|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497401|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497402|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497403|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497404|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497405|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497406|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497407|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497408|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497409|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497410|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497411|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497412|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497413|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497414|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497415|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497416|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497417|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497418|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497419|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497420|NCT00362115|O7|Outcome|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497421|NCT00362115|O6|Outcome|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497422|NCT00362115|O5|Outcome|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497423|NCT00362115|O4|Outcome|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497424|NCT00362115|O3|Outcome|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497425|NCT00362115|O2|Outcome|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497426|NCT00362115|O1|Outcome|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497427|NCT00362115|E7|Reported Event|Placebo QD|Matching placebo tablets, orally, once daily for up to 8 weeks.
497428|NCT00362115|E6|Reported Event|Olmesartan 20 mg QD|Olmesartan 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497429|NCT00362115|E5|Reported Event|Azilsartan Medoxomil 80 mg QD|Azilsartan medoxomil 80 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497430|NCT00362115|E4|Reported Event|Azilsartan Medoxomil 40 mg QD|Azilsartan medoxomil 40 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497431|NCT00362115|E3|Reported Event|Azilsartan Medoxomil 20 mg QD|Azilsartan medoxomil 20 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497432|NCT00362115|E2|Reported Event|Azilsartan Medoxomil 10 mg QD|Azilsartan medoxomil 10 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497433|NCT00362115|E1|Reported Event|Azilsartan Medoxomil 5 mg QD|Azilsartan medoxomil 5 mg and comparator matching placebo tablets, orally, once daily for up to 8 weeks.
497434|NCT00361972|B3|Baseline|Total|Total of all reporting groups
497435|NCT00361972|B2|Baseline|Placebo|placebo comparator to lansoprazole 30 mg twice daily for 6 weeks
497436|NCT00361972|B1|Baseline|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
497437|NCT00361972|P2|Participant Flow|Placebo|placebo comparator to lansoprazole, 30 mg, twice a day for 6 weeks
497438|NCT00361972|P1|Participant Flow|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
497439|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
497440|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
497441|NCT00361972|O2|Outcome|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
497442|NCT00361972|O1|Outcome|Lansoprazole|lansoprazole: 30 mg lansoprazole twice daily for 6 weeks
497443|NCT00361972|E2|Reported Event|Placebo|placebo comparator to lansoprazole 30 mg, twice daily for 6 weeks
497444|NCT00361972|E1|Reported Event|Lansoprazole|lansoprazole : 30 mg of lansoprazole twice daily for 6 weeks
497445|NCT00361634|B1|Baseline|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497446|NCT00361634|P1|Participant Flow|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497447|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497448|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497449|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497450|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497451|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497452|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497453|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497454|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497455|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497456|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497457|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497458|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497459|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497460|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497461|NCT00361634|O1|Outcome|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497462|NCT00361634|E1|Reported Event|Etanercept|Etanercept 50 mg administered by subcutaneous injection once weekly for up to 12 weeks.
497463|NCT00361595|B1|Baseline|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497464|NCT00361595|P1|Participant Flow|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497465|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497466|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497467|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497468|NCT00361595|O1|Outcome|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497469|NCT00361595|E1|Reported Event|Open Label|5 mg zoledronic acid in a single 15 minute IV (intervenous)
497470|NCT00361569|B5|Baseline|Total|Total of all reporting groups
497471|NCT00361569|B4|Baseline|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497472|NCT00361569|B3|Baseline|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497473|NCT00361569|B2|Baseline|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497474|NCT00361569|B1|Baseline|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497475|NCT00361569|P4|Participant Flow|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497476|NCT00361569|P3|Participant Flow|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497477|NCT00361569|P2|Participant Flow|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497478|NCT00361569|P1|Participant Flow|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497479|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497480|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497481|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497482|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497483|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497484|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497485|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497486|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497487|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497488|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497489|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497490|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497491|NCT00361569|O4|Outcome|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497492|NCT00361569|O3|Outcome|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497493|NCT00361569|O2|Outcome|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497494|NCT00361569|O1|Outcome|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497495|NCT00361569|E4|Reported Event|Placebo-b|2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497496|NCT00361569|E3|Reported Event|Placebo-a|1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497497|NCT00361569|E2|Reported Event|DR-2041b|Synthetic Conjugated Estrogens, A (DR-2041)-2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
497498|NCT00361569|E1|Reported Event|DR-2041a|Synthetic Conjugated Estrogens, A (DR-2041)-1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
497499|NCT00361504|B3|Baseline|Total|Total of all reporting groups
497500|NCT00361504|B2|Baseline|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
498311|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
497501|NCT00361504|B1|Baseline|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
497502|NCT00361504|P2|Participant Flow|Oxycodone|Oxycodone controlled release (CR) 20 to 50 mg twice daily (BID) for up to one year.
497503|NCT00361504|P1|Participant Flow|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250 mg twice daily (BID) for up to one year
497504|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
497505|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
497506|NCT00361504|O2|Outcome|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
497507|NCT00361504|O1|Outcome|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
497508|NCT00361504|E2|Reported Event|Oxycodone|Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year.
497509|NCT00361504|E1|Reported Event|Tapentadol (CG5503)|Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year
497510|NCT00361439|B3|Baseline|Total|Total of all reporting groups
497511|NCT00361439|B2|Baseline|Placebo|2 puffs of placebo spray once daily
497512|NCT00361439|B1|Baseline|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497513|NCT00361439|P2|Participant Flow|Placebo|2 puffs of placebo spray once daily
497514|NCT00361439|P1|Participant Flow|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497515|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
497516|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497517|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
497518|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497519|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
497520|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497521|NCT00361439|O2|Outcome|Placebo|2 puffs of placebo spray once daily
497522|NCT00361439|O1|Outcome|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497523|NCT00361439|E2|Reported Event|Placebo|2 puffs of placebo spray once daily
497524|NCT00361439|E1|Reported Event|Mometasone|Active intranasal steroid therapy daily for 2 weeks
497525|NCT00361374|B4|Baseline|Total|Total of all reporting groups
497526|NCT00361374|B3|Baseline|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
497527|NCT00361374|B2|Baseline|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
497528|NCT00361374|B1|Baseline|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
497529|NCT00361374|P3|Participant Flow|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
497530|NCT00361374|P2|Participant Flow|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
497531|NCT00361374|P1|Participant Flow|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
497532|NCT00361374|O3|Outcome|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
497533|NCT00361374|O2|Outcome|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
497534|NCT00361374|O1|Outcome|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
497535|NCT00361374|E3|Reported Event|Placebo|"Placebo capsule (980mg soybean oil)~Placebo: 980 milligram/day"
497536|NCT00361374|E2|Reported Event|Docosahexaenoic Acid (DHA)|"Docosahexaenoic acid (DHA) Omega-3, 1g/day~docosahexaenoic acid: 1 gram/day"
497537|NCT00361374|E1|Reported Event|Eicosapentaenoic Acid (EPA)|"Eicosapentaenoic acid (EPA) Omega-3, 1g/day~eicosapentaenoic acid: 1 gram/day"
497538|NCT00361335|B6|Baseline|Total|Total of all reporting groups
497539|NCT00361335|B5|Baseline|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
497540|NCT00361335|B4|Baseline|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
497541|NCT00361335|B3|Baseline|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
497542|NCT00361335|B2|Baseline|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
497543|NCT00361335|B1|Baseline|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497569|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
497607|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist and audio recordings
498312|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
497544|NCT00361335|P7|Participant Flow|EE/DRA -> 4mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered EE and DRA, respectively, depending on joint assessment results and received IV infusions of 4mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
497545|NCT00361335|P6|Participant Flow|EE/DRA -> 2mg/kg Golimumab + MTX|At Week 16 and Week 24 participants entered early escape (EE) and dose regimen adjustment (DRA), respectively, depending on joint assessment results and received IV infusions of 2mg/kg golimumab (as per protocol) for a minimum combined treatment period (initial treatment plus EE or DRA) of 48 weeks. This was followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
497546|NCT00361335|P5|Participant Flow|IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and Week 12. At Week 24, depending on joint assessment results (dose regimen adjustment), participants were switched to IV infusions of 4mg/kg golimumab every 12 weeks for a minimum combined treatment period (placebo plus golimumab) of 48 weeks. This was followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition participants received MTX at the same dose as before study entry. Participants still receiving placebo infusions at Week 48 were not eligible to enter the Extension Study.
497547|NCT00361335|P4|Participant Flow|4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
497548|NCT00361335|P3|Participant Flow|4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received MTX at the same dose as before study entry.
497549|NCT00361335|P2|Participant Flow|2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of SC injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received placebo (sham MTX) capsules during the IV Period only.
497550|NCT00361335|P1|Participant Flow|2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks followed by the option of subcutaneous (SC) injections of 50mg golimumab every 4 weeks for a further 24 weeks (Extension Study). In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497551|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
497552|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
497553|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
497554|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497555|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
497556|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497557|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497558|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
497559|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
497560|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
497561|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497562|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
497563|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497564|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497565|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
497566|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
497567|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
497568|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
498394|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
497570|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497571|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497572|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
497573|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
497574|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
497575|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497576|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
497577|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497578|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497579|NCT00361335|O7|Outcome|Group VII: Combined Groups II and IV|Combined Groups II and IV (2mg/kg or 4mg/kg Golimumab Only)
497580|NCT00361335|O6|Outcome|Group VI: Combined Groups I and III|Combined Groups I and III (2mg/kg or 4mg/kg Golimumab and Methotrexate)
497581|NCT00361335|O5|Outcome|Group V: IV Placebo + MTX|Participants received IV infusions of placebo at Week 0 and every 12 weeks thereafter through Week 48. In addition participants received MTX at the same dose as that before study entry.
497582|NCT00361335|O4|Outcome|Group IV: 4mg/kg Golimumab Only|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497583|NCT00361335|O3|Outcome|Group III: 4mg/kg Golimumab + MTX|Participants received IV infusions of 4mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received MTX at the same dose as before study entry.
497584|NCT00361335|O2|Outcome|Group II: 2mg/kg Golimumab Only|Participants received IV infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received placebo (sham MTX) capsules.
497585|NCT00361335|O1|Outcome|Group I: 2mg/kg Golimumab+ MTX|Participants received intravenous (IV) infusions of 2mg/kg golimumab at Week 0 and every 12 weeks thereafter for a minimum of 48 weeks. In addition, participants received methotrexate (MTX) at the same dose as before study entry.
497586|NCT00361335|E7|Reported Event|SC Period: 50mg Golimumab Only|Participants who received 50mg golimumab only. Participants must not have received any MTX while receiving 50mg SC golimumab.
497587|NCT00361335|E6|Reported Event|SC Period: 50mg Golimumab + MTX|Participants who received 50mg SC golimumab and MTX.
497588|NCT00361335|E5|Reported Event|IV Period: Placebo + MTX|Participants who received IV placebo and MTX only. Follow-up time was counted in this group until the participant started to receive IV golimumab.
497589|NCT00361335|E4|Reported Event|IV Period: 4mg/kg Golimumab Only|Participants who received at least one 4mg/kg IV golimumab dose. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 4mg/kg IV golimumab.
497590|NCT00361335|E3|Reported Event|IV Period: 4mg/kg Golimumab + MTX|Participants who received at least one 4 mg/kg IV golimumab dose and MTX. Follow-up time was counted in this treatment group from the first 4mg/kg IV golimumab infusion. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 4mg/kg IV golimumab.
497591|NCT00361335|E2|Reported Event|IV Period: 2mg/kg Golimumab Only|Participants who received 2mg/kg IV golimumab only. Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab doses. Participants must not have received any MTX while receiving 2mg/kg IV golimumab.
497592|NCT00361335|E1|Reported Event|IV Period: 2mg/kg Golimumab+ MTX|Participants who received 2mg/kg IV golimumab and methotrexate (MTX). Follow-up time was counted in this treatment group until the participant started to receive 4mg/kg IV golimumab. Participants may have missed one or more golimumab and/or MTX doses. Participants must have received MTX at some point while receiving 2mg/kg IV golimumab and before receiving 4mg/kg IV golimumab
497593|NCT00361283|B1|Baseline|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
497594|NCT00361283|P1|Participant Flow|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
497595|NCT00361283|O1|Outcome|Atorvastatin 80 MG/Day|Atorvastatin 80 MG/day
497596|NCT00361283|E1|Reported Event|Atorvastatin|80mg of atorvastatin given once daily for 16 weeks
497597|NCT00361270|B5|Baseline|Total|Total of all reporting groups
497598|NCT00361270|B4|Baseline|Arm 4|"Single-site study at MEDVA-Houston~EMG Biofeedback without hypnotic suggestion: 8 weekly 1-hour sessions of EMG Biofeedback without hypnotic suggestion"
497599|NCT00361270|B3|Baseline|Arm 3|"Single-site study at MEDVA-Houston~Home practice with hypnosis CDs: 2 weeks of 1-hour sessions of therapist-guided hypnosis + 6 weeks of daily home practice with hypnosis CDs"
497600|NCT00361270|B2|Baseline|Arm 2|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis with home practice with hypnosis CDs"
497601|NCT00361270|B1|Baseline|Arm 1|"Single-site study at MEDVA-Houston~Therapist-guided hypnosis: 8 weekly 1-hour sessions of therapist-guided hypnosis"
497602|NCT00361270|P4|Participant Flow|Biofeedback - 8|8 sessions biofeedback
497608|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist and audio recordings
497609|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
497610|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
497611|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
497612|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapists with audio recordings
497613|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis with hypnotherapist without recordings
497614|NCT00361270|O4|Outcome|Biofeedback - 8|8 1-hour sessions of EMG biofeedback
497615|NCT00361270|O3|Outcome|Hypnosis Practice 2|2 1-hour sessions of hypnosis with audio recordings
497616|NCT00361270|O2|Outcome|Hypnosis-Practice 8|8 1-hour sessions of hypnosis with audio recordings
497617|NCT00361270|O1|Outcome|Hypnosis-8|8 1-hour sessions of hypnosis without audio recordings
497618|NCT00361270|E4|Reported Event|Biofeedback - 8|8 1-hour sessions of EMG biofeedback without recordings
497619|NCT00361270|E3|Reported Event|Hypnosis Practice 2|2 1-hour sessions with hypnotherapist with audio recordings
497620|NCT00361270|E2|Reported Event|Hypnosis-Practice 8|8 1-hour sessions with hypnotherapist with audio recordings
497621|NCT00361270|E1|Reported Event|Hypnosis-8|8 1-hour sessions with hypnotherapist
497622|NCT00361257|B3|Baseline|Total|Total of all reporting groups
497623|NCT00361257|B2|Baseline|Matching Placebo|Placebo taken orally every 12 hours
497624|NCT00361257|B1|Baseline|Minocycline|100 mg orally every 12 hours
497625|NCT00361257|P2|Participant Flow|Matching Placebo|Placebo taken orally every 12 hours
497626|NCT00361257|P1|Participant Flow|Minocycline|100 mg orally every 12 hours
497627|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497628|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497629|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497630|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497631|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497632|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497633|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
497634|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
497635|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
497636|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
497637|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
497638|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
497639|NCT00361257|O2|Outcome|Arm 2: Matching Placebo|"orally every 12 hours~Placebo (Tetracycline): Tetracycline antibiotic placebo, orally every 12 hours"
497640|NCT00361257|O1|Outcome|Arm 1: Minocycline|"100 mg orally every 12 hours~Minocycline: Tetracycline antibiotic, 100 mg taken orally every 12 hours"
497641|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497642|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497643|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497644|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497645|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497646|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497647|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497648|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497649|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497650|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497651|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497652|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497653|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497654|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497655|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497656|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497657|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497658|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497659|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497660|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497661|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497662|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497663|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497664|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497665|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497666|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497667|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497668|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497669|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497670|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497671|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497672|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497673|NCT00361257|O2|Outcome|Matching Placebo|Placebo taken orally every 12 hours
497674|NCT00361257|O1|Outcome|Minocycline|100 mg orally every 12 hours
497675|NCT00361257|E2|Reported Event|Matching Placebo|Placebo taken orally every 12 hours
497677|NCT00361231|B1|Baseline|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
497678|NCT00361231|P1|Participant Flow|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects."
497679|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
497680|NCT00361231|O1|Outcome|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of studytreatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Oxaliplatin"
497681|NCT00361231|E1|Reported Event|Bevacizumab, Gemcitabine, Oxaliplatin|"The chemotherapy drugs are given twice every 28 days. This 28 day period is called a cycle of study treatment.~Bevacizumab will be administered by IV over 90 minutes on day 1 and day 15. Gemcitabine will be administered by IV over 1 hour and 40 minutes on days 1 and 15 of each cycle. Oxaliplatin will be administered by IV for 2 hours on days 1 and 15 of each cycle.~Participants will continue to receive cycles of study treatment as long as their disease does not progress and they are not experiencing any serious side effects.~Bevacizumab: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as lond as their disease does not progress and they do not experience any serious side effects.~Gemcitabine: Given intravenously on days 1 and 15 of each 28-day cycle. Participants may continue to receive study treatment as long as their disease does not progress and they do not experience any serious side eff"
497682|NCT00361218|B1|Baseline|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
497683|NCT00361218|P1|Participant Flow|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
497684|NCT00361218|O1|Outcome|Open-label Selective Serotonin Reuptake Inhibitor (SSRI)|"citalopram or escitalopram~open-label selective serotonin reuptake inhibitor (SSRI): Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
497685|NCT00361218|E1|Reported Event|Open-label SSRI|"citalopram or escitalopram~open-label SSRI : Duration is 8 weeks. For escitalopram, starting dose is 10mg po qd,which can be increased up to 30mg po qd per clinical discretion. For citalopram, starting dose is 20mg po qd, which can be increased up to 60mg po qd per clinical discretion."
497686|NCT00361140|B4|Baseline|Total|Total of all reporting groups
497687|NCT00361140|B3|Baseline|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
497688|NCT00361140|B2|Baseline|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
497689|NCT00361140|B1|Baseline|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
497690|NCT00361140|P3|Participant Flow|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
497691|NCT00361140|P2|Participant Flow|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
497692|NCT00361140|P1|Participant Flow|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
497693|NCT00361140|O3|Outcome|AUC 9000|Busuflan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40mg/m2 IV over 1 hour
497694|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40mg/m2 IV over 1 hour
497695|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40mg/m2 IV over 1 hour
497696|NCT00361140|O3|Outcome|AUC 9000|Busuflan AUC Level 3: 9000 +/- 900 uM-min Fludarabine 40mg/m2 IV over 1 hour
497697|NCT00361140|O2|Outcome|AUC 7500|Busulfan AUC Level 2: 7500 +/- 750 uM-min Fludarabine 40mg/m2 IV over 1 hour
497698|NCT00361140|O1|Outcome|AUC 6000|Busulfan AUC Level 1: 6000 +/- 600 uM-min Fludarabine 40mg/m2 IV over 1 hour
497699|NCT00361140|E3|Reported Event|AUC Level 3|Busulfan targeted area under the curve, level 3: 9000 +/- 900 uM-min
497700|NCT00361140|E2|Reported Event|AUC Level 2|Busulfan targeted area under the curve, level 2: 7500 +/- 750 uM-min
497701|NCT00361140|E1|Reported Event|AUC Level 1|Busulfan targeted area under the curve, level 1: 6000 +/- 600 uM-min
497702|NCT00360971|B3|Baseline|Total|Total of all reporting groups
497703|NCT00360971|B2|Baseline|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
497704|NCT00360971|B1|Baseline|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
497705|NCT00360971|P2|Participant Flow|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
497706|NCT00360971|P1|Participant Flow|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
497707|NCT00360971|O2|Outcome|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
497708|NCT00360971|O1|Outcome|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
497709|NCT00360971|E2|Reported Event|Palifermin|Concurrent radiation therapy, cisplatin, and palifermin followed by neck dissection for indicated patients.
497710|NCT00360971|E1|Reported Event|Placebo|Concurrent radiation therapy, cisplatin, and placebo followed by neck dissection for indicated patients.
497711|NCT00360828|B1|Baseline|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497712|NCT00360828|P1|Participant Flow|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497713|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497714|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497715|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497716|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497717|NCT00360828|O1|Outcome|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497757|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497758|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497718|NCT00360828|E1|Reported Event|Irinotecan Hydrochloride (HCI) Treatment|Participants were given irinotecan at a fixed dose: [350 mg/m2 in patients either not on anti-seizure drugs or on anti-seizure drugs which do not interfere with the metabolism of Irinotecan; 600 mg/m2 in patients on anti-seizure drugs which interfere with the metabolism of Irinotecan] once every 21 days. Depending on how many side effects were experienced with the first cycle [first 21 days], the dose of both drugs may remain the same or may be decreased to make the treatment better tolerated with less side effects. The irinotecan was given to through a vein over 90 minutes.
497719|NCT00360724|B3|Baseline|Total|Total of all reporting groups
497720|NCT00360724|B2|Baseline|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497721|NCT00360724|B1|Baseline|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497722|NCT00360724|P2|Participant Flow|Placebo Treatment|placebo treatment, treatment with matching capsules of placebo
497723|NCT00360724|P1|Participant Flow|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497724|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497725|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497726|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497727|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497728|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497729|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497730|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497731|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497732|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497733|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497734|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497735|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497736|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497737|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497738|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
497739|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497740|NCT00360724|O2|Outcome|Placebo Treatment|placebo treatment, with capsules matching the duloxetine medication
497741|NCT00360724|O1|Outcome|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497742|NCT00360724|E2|Reported Event|Placebo Treatment|placebo treatment: treatment with placebo capsules that match active medication capsules
497743|NCT00360724|E1|Reported Event|Duloxetine (Cymbalta)|Duloxetine medication, ranging from 30 to 120 mg/day
497744|NCT00360698|B3|Baseline|Total|Total of all reporting groups
497745|NCT00360698|B2|Baseline|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497746|NCT00360698|B1|Baseline|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497747|NCT00360698|P2|Participant Flow|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497748|NCT00360698|P1|Participant Flow|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497749|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497750|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497751|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497752|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497753|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497754|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497755|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497756|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497900|NCT00360555|B5|Baseline|Total|Total of all reporting groups
497759|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497760|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497761|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497762|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497763|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497764|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497765|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497766|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497767|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497768|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497769|NCT00360698|O2|Outcome|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497770|NCT00360698|O1|Outcome|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497771|NCT00360698|E2|Reported Event|Insulin Glargine+Metformin+Glimepiride|Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497772|NCT00360698|E1|Reported Event|Insulin Glulisine+Insulin Glargine+Metformin+Glimepiride|Insulin Glulisine (One daily injection at main meal) + Insulin Glargine (One daily injection at bedtime) + Metformin (At same dosage as during the run-in period) + Glimepiride (At same dosage as during the run-in period)
497773|NCT00360685|B3|Baseline|Total|Total of all reporting groups
497774|NCT00360685|B2|Baseline|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
497775|NCT00360685|B1|Baseline|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
497776|NCT00360685|P2|Participant Flow|Tacrolimus And Mycophenolate Mofetil|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MMF 30 mg/kg/day IV in 2 divided doses beginning day 0. Dosing should be based on the lesser of adjusted ideal body weight or actual body weight. The IV dose will be converted to the oral formulation when spatient is able to tolerate oral medications. Oral dosing may be capped at 1 gram twice daily. In the absence of GVHD a tapering schedule will begin on day +240 (+14) and be completed on day +360 (+14)."
497777|NCT00360685|P1|Participant Flow|Tacrolimus And Methotrexate|"All patients will receive TAC 0.03 mg/kg/24h as a continuous IV infusion beginning day –3 (day 0 being the anticipated day of hematopoietic stem cell infusion). Tacrolimus dosing should be based on ideal body weight. TAC levels should be measured on day 0 then at least twice weekly for the first month and the dose will be adjusted to maintain whole blood levels of 5-15ng/mL. When the patient is able to tolerate oral medications, the total daily dose of IV TAC will be converted to oral dosing at a 1:3 (IV:PO) ratio. The daily oral dose will be divided into twice daily dosing. Full dose TAC will be given until day +60 (+7) when tapering will begin in the absence of GVHD. Provided no GVHD develops, TAC should be discontinued by day +180 (+14).~MTX 15 mg/m2 IV day +1 then 10 mg/m2 IV on days +3, +6, and +11."
497778|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
497779|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
497780|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
497781|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
497782|NCT00360685|O2|Outcome|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
497783|NCT00360685|O1|Outcome|Tacrolimus And Methotrexate|Tacrolimus And Methotrexate
497784|NCT00360685|E2|Reported Event|Tacrolimus And Mycophenolate Mofetil|Tacrolimus (TAC) And Mycophenolate Mofetil (MMF)
497785|NCT00360685|E1|Reported Event|Tacrolimus And Methotrexate|Tacrolimus (TAC) And Methotrexate (MTX)
497786|NCT00360672|B1|Baseline|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
497787|NCT00360672|P1|Participant Flow|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
497788|NCT00360672|O1|Outcome|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
497789|NCT00360672|E1|Reported Event|Revlimid|Revlimid 25 mg/day, orally for 21 days with 7 days rest (28 day cycle).
497790|NCT00360568|B3|Baseline|Total|Total of all reporting groups
497791|NCT00360568|B2|Baseline|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497792|NCT00360568|B1|Baseline|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497793|NCT00360568|P2|Participant Flow|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497794|NCT00360568|P1|Participant Flow|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received levodopa-carbidopa intestinal gel (LCIG), delivered through a percutaneous endoscopic gastrostomy with jejunal extension (PEG-J), administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497795|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497796|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497797|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497798|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497799|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497901|NCT00360555|B4|Baseline|Placebo|flibanserin: placebo
497902|NCT00360555|B3|Baseline|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
497903|NCT00360555|B2|Baseline|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
497800|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497801|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497802|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497803|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497804|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497805|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497806|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497807|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497808|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497809|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
498476|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
497810|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497811|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497812|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497813|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497814|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497815|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497816|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497817|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497818|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497819|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497904|NCT00360555|B1|Baseline|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
497905|NCT00360555|P4|Participant Flow|Placebo|flibanserin: placebo
497820|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497821|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497822|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497823|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497824|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497825|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497826|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497827|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497828|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497829|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497830|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497831|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497832|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497833|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497834|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497835|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497836|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497837|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497838|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497839|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
508747|NCT00325819|B3|Baseline|Total|Total of all reporting groups
497840|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497841|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497842|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497843|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497844|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497845|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497846|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497847|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497848|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497849|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497906|NCT00360555|P3|Participant Flow|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
508841|NCT00325468|E6|Reported Event|All Participants|
497850|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497851|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497852|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497853|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497854|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497855|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497856|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497857|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497858|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497859|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497860|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497861|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497862|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497863|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497864|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497865|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497866|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497867|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497868|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497869|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
508842|NCT00325468|E5|Reported Event|Alendronate 70 mg QW|
497870|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497871|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497872|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497873|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497874|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497875|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497876|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497877|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497878|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497879|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497907|NCT00360555|P2|Participant Flow|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
497908|NCT00360555|P1|Participant Flow|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
497880|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497881|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497882|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497883|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497884|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497885|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497886|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497887|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497888|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497889|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497890|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497891|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497892|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497893|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497894|NCT00360568|O3|Outcome|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497895|NCT00360568|O2|Outcome|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497896|NCT00360568|O1|Outcome|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497897|NCT00360568|E3|Reported Event|LCIG (All Participants)|All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately 16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.
497898|NCT00360568|E2|Reported Event|LCIG (Previous: Placebo Gel + Levodopa-Carbidopa Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of the previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with Placebo Gel + Levodopa-Carbidopa Capsules."
497899|NCT00360568|E1|Reported Event|LCIG (Previous: LCIG + Placebo Capsules)|"All participants received LCIG, delivered through a PEG-J, administered for up to 12 months (52 weeks). Starting dose of LCIG was based on the optimized oral levodopa-carbidopa dose that the participant was receiving just prior to randomization in Study S187.3.001 (NCT00357994) and Study S187.3.002 (NCT00660387), administered in the morning of the first day following Study Day 86 of these previous studies. The LCIG infusion was expected to infuse over approximately16 hours each day with a rate of infusion within the range of 1 to 10 mL/hour (20 to 200 mg of levodopa/hour) in most instances.~In NCT00357994/NCT00660387 (previous study), these participants received double-blind, double-dummy treatment with LCIG + Placebo Capsules."
497910|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
497911|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
497912|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
497913|NCT00360555|O4|Outcome|Placebo|flibanserin: placebo
497914|NCT00360555|O3|Outcome|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
497915|NCT00360555|O2|Outcome|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
497916|NCT00360555|O1|Outcome|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
497917|NCT00360555|E4|Reported Event|Placebo|flibanserin: placebo
497918|NCT00360555|E3|Reported Event|Flibanserin 50mg b.i.d./100mg Qhs|flibanserin: 50 mg twice daily/100 once at bedtime
497919|NCT00360555|E2|Reported Event|Flibanserin 50mg Qhs/b.i.d|flibanserin: 50 mg once at bedtime/twice daily
497920|NCT00360555|E1|Reported Event|Flibanserin 25 mg b.i.d|flibanserin: 25 mg twice daily
497921|NCT00360529|B4|Baseline|Total|Total of all reporting groups
497922|NCT00360529|B3|Baseline|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497923|NCT00360529|B2|Baseline|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497924|NCT00360529|B1|Baseline|Placebo|placebo at bedtime
497925|NCT00360529|P3|Participant Flow|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497926|NCT00360529|P2|Participant Flow|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497927|NCT00360529|P1|Participant Flow|Placebo|placebo at bedtime
497928|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497929|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497930|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497931|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497932|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497933|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497934|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497935|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497936|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497937|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497938|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497939|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497940|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497941|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497942|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497943|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497944|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497945|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497946|NCT00360529|O3|Outcome|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497947|NCT00360529|O2|Outcome|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497948|NCT00360529|O1|Outcome|Placebo|placebo at bedtime
497949|NCT00360529|E3|Reported Event|Flibanserin 100 mg q.h.s|Flibanserin 100 mg at bedtime
497950|NCT00360529|E2|Reported Event|Flibanserin 50 mg q.h.s.|Flibanserin 50 mg at bedtime
497951|NCT00360529|E1|Reported Event|Placebo|placebo at bedtime
497952|NCT00360490|B3|Baseline|Total|Total of all reporting groups
497953|NCT00360490|B2|Baseline|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497954|NCT00360490|B1|Baseline|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497955|NCT00360490|P2|Participant Flow|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497956|NCT00360490|P1|Participant Flow|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497957|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497958|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497959|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497960|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497961|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497962|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497963|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497964|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497965|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497966|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497967|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497968|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497969|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497970|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497971|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497972|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497973|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497974|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497975|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497976|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497977|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497978|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497979|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497980|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497981|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497982|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497983|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497984|NCT00360490|O2|Outcome|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497985|NCT00360490|O1|Outcome|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497986|NCT00360490|E2|Reported Event|Medroxyprogesterone Acetate (MPA)|Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
497987|NCT00360490|E1|Reported Event|Levonorgestrel Intrauterine System (LNG IUS) 20µg Per 24 Hours|Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles.
497988|NCT00360412|B3|Baseline|Total|Total of all reporting groups
497989|NCT00360412|B2|Baseline|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497990|NCT00360412|B1|Baseline|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497991|NCT00360412|P2|Participant Flow|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497992|NCT00360412|P1|Participant Flow|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497993|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497994|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
498020|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498021|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
497995|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497996|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497997|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497998|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
497999|NCT00360412|O2|Outcome|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
498000|NCT00360412|O1|Outcome|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
498001|NCT00360412|E2|Reported Event|Perampanel (Perampanel 2 mg or 4 mg During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
498002|NCT00360412|E1|Reported Event|Perampanel (Placebo During Core Study)|Subjects entered this open-label extension study from the double-blind core studies (E2007-E044-301 and E2007-A001-302). Subjects started on perampanel 2mg once daily for two weeks, followed by 4mg once daily for 2 weeks (Titration Phase); Subjects then continued onto the maintenance phase of perampanel 4mg once daily for 2 weeks. Subjects that did not tolerate the study drug at 4mg were allowed to down-titrate to 2mg. Subjects that did not tolerate 2mg were withdrawn from the study.
498003|NCT00360399|B4|Baseline|Total|Total of all reporting groups
498004|NCT00360399|B3|Baseline|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498005|NCT00360399|B2|Baseline|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498006|NCT00360399|B1|Baseline|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498007|NCT00360399|P3|Participant Flow|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498008|NCT00360399|P2|Participant Flow|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498009|NCT00360399|P1|Participant Flow|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498010|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498011|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498012|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498013|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498014|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498015|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498016|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498017|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498018|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498019|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498294|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498022|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498023|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498024|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498025|NCT00360399|O3|Outcome|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498026|NCT00360399|O2|Outcome|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498027|NCT00360399|O1|Outcome|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498028|NCT00360399|E3|Reported Event|Cognitive Behavioral Therapy (CBT)|Participants were randomized to receive 16 one-hour sessions of cognitive behavioral therapy (CBT) delivered over 12 weeks
498029|NCT00360399|E2|Reported Event|Duloxetine|Participants were randomized to receive treatment with duloxetine for 12 weeks, at a dose of 30 to 60 mg per day
498030|NCT00360399|E1|Reported Event|Escitalopram|Participants were randomized to receive treatment with escitalopram for 12 weeks, at a dose of 10 to 20 mg per day
498031|NCT00360360|B1|Baseline|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
498032|NCT00360360|P1|Participant Flow|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
498033|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
498034|NCT00360360|O1|Outcome|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
498035|NCT00360360|E1|Reported Event|Bevacizumab/Paclitaxel/Carboplatin/Erlotinib|Bevacizumab 15mg/kg IV infusion,Day 1 Paclitaxel 175mg/m2, 1-3 hour IV infusion,Day 1 Carboplatin AUC 6.0 IV Day 1 Erlotinib 150 mg by mouth daily
498036|NCT00360334|B3|Baseline|Total|Total of all reporting groups
498037|NCT00360334|B2|Baseline|Insulin Glargine|dosing based on treat to target protocol
498038|NCT00360334|B1|Baseline|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498039|NCT00360334|P2|Participant Flow|Insulin Glargine|dosing based on treat to target protocol
498040|NCT00360334|P1|Participant Flow|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498041|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498042|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498043|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498044|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498045|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498046|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498047|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498048|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498049|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498050|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498051|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498052|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498053|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498054|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498055|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498056|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498057|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498058|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498059|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498060|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498061|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498062|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498063|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498064|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498065|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498066|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498067|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498068|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498069|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498070|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498071|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498072|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498073|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498074|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498075|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498076|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498077|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498078|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498079|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498080|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498081|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498082|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498083|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498084|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498085|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498086|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498087|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498088|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498089|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498090|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498091|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498092|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498093|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498094|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498095|NCT00360334|O2|Outcome|Insulin Glargine|dosing based on treat to target protocol
498096|NCT00360334|O1|Outcome|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498097|NCT00360334|E2|Reported Event|Insulin Glargine|dosing based on treat to target protocol
498098|NCT00360334|E1|Reported Event|Exenatide|5mcg twice daily for 4 weeks, followed by 10mcg twice daily for 22 weeks
498099|NCT00360308|B4|Baseline|Total|Total of all reporting groups
498100|NCT00360308|B3|Baseline|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498101|NCT00360308|B2|Baseline|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498102|NCT00360308|B1|Baseline|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498103|NCT00360308|P3|Participant Flow|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498104|NCT00360308|P2|Participant Flow|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498105|NCT00360308|P1|Participant Flow|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498106|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498107|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498108|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498109|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498110|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498111|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 1 fewer subject due to inavailability of the data
498112|NCT00360308|O3|Outcome|Perampanel|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
498113|NCT00360308|O2|Outcome|Entacapone|The total number of subjects reflects 5 fewer subjects due to inavailability of the data
498114|NCT00360308|O1|Outcome|Placebo|The total number of subjects reflects 3 fewer subjects due to inavailability of the data
498115|NCT00360308|O3|Outcome|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498116|NCT00360308|O2|Outcome|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498117|NCT00360308|O1|Outcome|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498118|NCT00360308|E3|Reported Event|Perampanel|Perampanel 2 mg (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498119|NCT00360308|E2|Reported Event|Entacapone|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as one entacapone 200 mg dose with each dose of levodopa.
498120|NCT00360308|E1|Reported Event|Placebo|Placebo identical to perampanel (Weeks 0 to 2 one dose per day, Weeks 2 to 18 two doses per day); as well as a placebo identical to entacapone with each dose of levodopa.
498121|NCT00360282|B1|Baseline|All Study Participants|Includes participants (migraineurs) with and without vertigo
498122|NCT00360282|P4|Participant Flow|Without Vertigo; Rizatriptan - Placebo|These participants suffered from migraine without associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
498123|NCT00360282|P3|Participant Flow|With Vertigo; Rizatriptan - Placebo|These participants suffered from migraine and had associated vertigo/dizziness. They received Rizatriptan on visit 1 and placebo on visit 2.
498124|NCT00360282|P2|Participant Flow|Without Vertigo; Placebo - Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. This group received placebo on visit 1 and Rizatriptan on visit 2.
498125|NCT00360282|P1|Participant Flow|With Vertigo; Placebo-Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They were given placebo on visit one and Rizatriptan on visit 2.
498126|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
498127|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
498128|NCT00360282|O2|Outcome|Placebo Visit|Participants were pre-treated with placebo prior to vestibular stimulation.
498129|NCT00360282|O1|Outcome|Rizatriptan Visit|Subjects were pre-treated with Rizatriptan prior to vestibular stimulation.
498130|NCT00360282|E4|Reported Event|With Vertigo; Rizatriptan|These participants suffered from migraines with associated dizziness/vertigo. They received Rizatriptan on one of the visits.
498131|NCT00360282|E3|Reported Event|With Vertigo; Placebo|These participants suffered from migraines with associated dizziness/vertigo. They received Placebo on one of the visits.
498132|NCT00360282|E2|Reported Event|Without Vertigo; Rizatriptan|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Rizatriptan on one of the visits.
498133|NCT00360282|E1|Reported Event|Without Vertigo; Placebo|These participants suffered from migraines but did not have associated dizziness/vertigo. They received Placebo on one of the visits.
498134|NCT00360269|B3|Baseline|Total|Total of all reporting groups
498135|NCT00360269|B2|Baseline|Placebo|Flexible dose up to 100mg/day
498136|NCT00360269|B1|Baseline|Atomoxetine|Flexible dose up to 100mg/day
498137|NCT00360269|P2|Participant Flow|Placebo|Flexible dose up to 100mg/day
498138|NCT00360269|P1|Participant Flow|Atomoxetine|Flexible dose up to 100mg/day
498139|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
498140|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
498141|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
498142|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
498143|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
498144|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
498145|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
498146|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
498147|NCT00360269|O2|Outcome|Placebo|Flexible dose up to 100mg/day
498148|NCT00360269|O1|Outcome|Atomoxetine|Flexible dose up to 100mg/day
498149|NCT00360269|E2|Reported Event|Placebo|Flexible dose up to 100mg/day
498150|NCT00360269|E1|Reported Event|Atomoxetine|Flexible dose up to 100mg/day
498151|NCT00360243|B5|Baseline|Total|Total of all reporting groups
498152|NCT00360243|B4|Baseline|Placebo|"twice daily for 24 weeks~placebo: placebo"
498153|NCT00360243|B3|Baseline|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
498154|NCT00360243|B2|Baseline|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
498155|NCT00360243|B1|Baseline|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
498156|NCT00360243|P4|Participant Flow|Placebo|"twice daily for 24 weeks~placebo: placebo"
498157|NCT00360243|P3|Participant Flow|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
498158|NCT00360243|P2|Participant Flow|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
498159|NCT00360243|P1|Participant Flow|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
498160|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
498161|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
498162|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
498163|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
498164|NCT00360243|O4|Outcome|Placebo|"twice daily for 24 weeks~placebo: placebo"
498165|NCT00360243|O3|Outcome|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
498166|NCT00360243|O2|Outcome|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
498167|NCT00360243|O1|Outcome|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
498168|NCT00360243|E4|Reported Event|Placebo|"twice daily for 24 weeks~placebo: placebo"
498169|NCT00360243|E3|Reported Event|Flibanserin 50mg b.i.d.|"50 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 50mg b.i.d."
498170|NCT00360243|E2|Reported Event|Flibanserin 50mg Qhs|"50 mg taken once daily at bedtime for 24 weeks~flibanserin: Experimental: flibanserin 50mg qhs"
498171|NCT00360243|E1|Reported Event|Flibanserin 25 mg b.i.d|"25 mg twice daily for 24 weeks~flibanserin: Experimental: flibanserin 25 mg b.i.d"
498172|NCT00360009|B4|Baseline|Total|Total of all reporting groups
498173|NCT00360009|B3|Baseline|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498174|NCT00360009|B2|Baseline|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498175|NCT00360009|B1|Baseline|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498176|NCT00360009|P3|Participant Flow|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498177|NCT00360009|P2|Participant Flow|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498178|NCT00360009|P1|Participant Flow|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498179|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498180|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498181|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498182|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498183|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498184|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498185|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498186|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498187|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498188|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498189|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498190|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498191|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498192|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498193|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498194|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498195|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498196|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498197|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498198|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498199|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498200|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498201|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498202|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498203|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498204|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498205|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498206|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498207|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498208|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498209|NCT00360009|O3|Outcome|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498210|NCT00360009|O2|Outcome|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498211|NCT00360009|O1|Outcome|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498212|NCT00360009|E3|Reported Event|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS)|Globus Pallidus Interna (GPi) Deep Brain Stimulation (DBS) intervention to treat Parkinson's Disease (PD)
498213|NCT00360009|E2|Reported Event|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS)|Subthalamic Nucleus (STN) Deep Brain Stimulation (DBS) intervention to treat Parkinson's disease (PD)
498214|NCT00360009|E1|Reported Event|No Deep Brain Stimuation (DBS) Control Group|A control group of PD patients that have not undergone surgical intervention (ie. DBS).
498215|NCT00359983|B4|Baseline|Total|Total of all reporting groups
498295|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498216|NCT00359983|B3|Baseline|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498217|NCT00359983|B2|Baseline|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498218|NCT00359983|B1|Baseline|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498219|NCT00359983|P3|Participant Flow|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498220|NCT00359983|P2|Participant Flow|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498221|NCT00359983|P1|Participant Flow|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498222|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498223|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498224|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498225|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498226|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498227|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498228|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498229|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498230|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498231|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498232|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498233|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498234|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498235|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498236|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498237|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498238|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498239|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498296|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498240|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498241|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498242|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498243|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498244|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498245|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498246|NCT00359983|O3|Outcome|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498247|NCT00359983|O2|Outcome|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498248|NCT00359983|O1|Outcome|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498249|NCT00359983|E3|Reported Event|ActHIB 3-dose + MenHibrix 4th-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498250|NCT00359983|E2|Reported Event|ActHIB 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of ActHIB co-administered with Pediarix and Prevnar and a 4th dose of ActHIB co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498251|NCT00359983|E1|Reported Event|MenHibrix 4-dose Group|Subjects received in the primary study (NCT00129129) 3 doses of MenHibrix co-administered with Pediarix and Prevnar and a 4th dose of MenHibrix co-administered with Prevnar. No vaccines were administered during this long-term persistence study.
498252|NCT00359944|B4|Baseline|Total|Total of all reporting groups
498253|NCT00359944|B3|Baseline|Placebo|Sugar Pill twice daily
498254|NCT00359944|B2|Baseline|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498255|NCT00359944|B1|Baseline|AC-3933|AC-3933, 5mg twice daily
498256|NCT00359944|P3|Participant Flow|Placebo|Sugar Pill twice daily
498257|NCT00359944|P2|Participant Flow|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498258|NCT00359944|P1|Participant Flow|AC-3933, 5 mg|AC-3933, 5mg twice daily
498259|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
498260|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498261|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
498262|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
498263|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498264|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
498265|NCT00359944|O3|Outcome|Placebo|Sugar Pill twice daily
498266|NCT00359944|O2|Outcome|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498267|NCT00359944|O1|Outcome|AC-3933, 5 mg|AC-3933, 5mg twice daily
498268|NCT00359944|E3|Reported Event|Placebo|Sugar Pill twice daily
498269|NCT00359944|E2|Reported Event|AC-3933, 20 mg|AC-3933, 20 mg twice daily
498270|NCT00359944|E1|Reported Event|AC-3933, 5 mg|AC-3933, 5mg twice daily
498271|NCT00359801|B3|Baseline|Total|Total of all reporting groups
498272|NCT00359801|B2|Baseline|Non-Exubera®|Usual diabetes care
498273|NCT00359801|B1|Baseline|Exubera®|Exubera® plus usual diabetes care
498274|NCT00359801|P2|Participant Flow|Non-Exubera®|Usual diabetes care
498275|NCT00359801|P1|Participant Flow|Exubera®|Exubera® plus usual diabetes care
498276|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498277|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498278|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498279|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498280|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498281|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498282|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498283|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498284|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498285|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498286|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498287|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498288|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498289|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498290|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498291|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498292|NCT00359801|O2|Outcome|Non-Exubera®|Usual diabetes care
498293|NCT00359801|O1|Outcome|Exubera®|Exubera® plus usual diabetes care
498313|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498314|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498315|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498316|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498317|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498318|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498319|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498320|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498321|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498322|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498323|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498324|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498325|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498326|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498327|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498328|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498329|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498330|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498331|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498332|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498333|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498334|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498335|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498336|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498337|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498338|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498339|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498340|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498341|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498342|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498343|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498344|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498345|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498346|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498347|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498348|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498349|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498350|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498351|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498352|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498353|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498354|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498355|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498356|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498357|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498358|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498359|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498360|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498361|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498362|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498363|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498364|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498365|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498366|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498367|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498368|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498369|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498370|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498371|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498372|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498373|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498374|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498375|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498376|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498377|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498378|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498379|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498380|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498381|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498382|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498383|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498384|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498385|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498386|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498387|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498388|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498389|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498390|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498391|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498392|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498393|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498395|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498396|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498397|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498398|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498399|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498400|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498401|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498402|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498403|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498404|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498405|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498406|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498407|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498408|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498409|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498410|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498411|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498412|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498413|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498414|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498415|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498416|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498417|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498418|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498419|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498420|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498421|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498422|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498423|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498424|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498425|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498426|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498427|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498428|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498429|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498430|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498431|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498432|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498433|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498434|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498435|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498436|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498437|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498438|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498439|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498440|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498441|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498442|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498443|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498444|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498445|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498446|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498447|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498448|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498449|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498450|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498451|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498452|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498453|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498454|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498455|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498456|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498457|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498458|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498459|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498460|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498461|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498462|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498463|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498464|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498465|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498466|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498467|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498468|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498469|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498470|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498471|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498472|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498473|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498474|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498475|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498477|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498478|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498479|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498480|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498481|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498482|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498483|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498484|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498485|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498486|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498487|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498488|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498489|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498490|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498491|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498492|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498493|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498494|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498495|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498496|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498497|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498498|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498499|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498500|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498501|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498502|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498503|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498504|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498505|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498506|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498507|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498508|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498509|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498510|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498511|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498512|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498513|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498514|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498515|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498516|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498517|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498518|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498519|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498520|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498521|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498522|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498523|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498524|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498525|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498526|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498527|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498528|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498529|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498530|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498531|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498532|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498533|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498534|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498535|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498536|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498537|NCT00359788|O2|Outcome|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498538|NCT00359788|O1|Outcome|Tiotropium|18 mcg once daily
498539|NCT00359788|E2|Reported Event|Combivent (Ipratropium/Albuterol)|2 actuations 4 times daily
498540|NCT00359788|E1|Reported Event|Tiotropium|18 mcg once daily
498541|NCT00359762|B3|Baseline|Total|Total of all reporting groups
498542|NCT00359762|B2|Baseline|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498543|NCT00359762|B1|Baseline|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498544|NCT00359762|P5|Participant Flow|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498545|NCT00359762|P4|Participant Flow|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
498546|NCT00359762|P3|Participant Flow|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498928|NCT00358826|P8|Participant Flow|Placebo MDCT Substudy|Matching Placebo, 24 weeks
498547|NCT00359762|P2|Participant Flow|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498548|NCT00359762|P1|Participant Flow|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498549|NCT00359762|O3|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
498550|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498551|NCT00359762|O1|Outcome|Exen + Metformin + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498552|NCT00359762|O1|Outcome|Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
498553|NCT00359762|O2|Outcome|Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498554|NCT00359762|O1|Outcome|Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498555|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498556|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498557|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498558|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498559|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498560|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498561|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498562|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498563|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498564|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498565|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498566|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498567|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498568|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498569|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498570|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498571|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498572|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498573|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498574|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498575|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498576|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498577|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498578|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498579|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498580|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498581|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498582|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498583|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498584|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498585|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498586|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498587|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498588|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498589|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498590|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498591|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498592|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498593|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498594|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498595|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498596|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498597|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498598|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498599|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498600|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498601|NCT00359762|O2|Outcome|Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498602|NCT00359762|O1|Outcome|Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498603|NCT00359762|E5|Reported Event|Period II, Exen + Met|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period II) and daily oral Metformin
498604|NCT00359762|E4|Reported Event|Period III, Glim + Met + Exen - Not Randomized|Exenatide 10 mcg twice daily subcutaneously injected (5 mcg exenatide per dose for the first 4 weeks followed by 10 mcg exenatide per dose for the remainder of period III) was added to oral Glimepiride once daily and daily oral Metformin in Period III
498605|NCT00359762|E3|Reported Event|Period III, Exen + Met + Pio or Rosi - Randomized|Oral Rosiglitazone or Pioglitazone once or twice daily, started 15 mg per day, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498606|NCT00359762|E2|Reported Event|Period III, Exen + Met + Glim - Randomized|Glimepiride once daily, started at 1 mg dose and titrated up to maintenance doses, was added to Exenatide 10 mcg twice daily subcutaneously injected and daily oral Metformin in Period III
498607|NCT00359762|E1|Reported Event|Period II, Glim + Met|Glimepiride one 1 mg tablet daily with subsequent titration every 4 weeks to maximally-tolerated dose for the remainder of Period II and daily oral Metformin
498608|NCT00359736|B3|Baseline|Total|Total of all reporting groups
498609|NCT00359736|B2|Baseline|Placebo|Identical Placebo: 20 mg TID orally
499645|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
498610|NCT00359736|B1|Baseline|Sildenafil|Sildenafil 20 mg TID orally: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
498611|NCT00359736|P2|Participant Flow|Placebo|Control group: Identical Placebo 20 mg TID orally
498612|NCT00359736|P1|Participant Flow|Sildenafil|Sildenafil 20 mg TID orally : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
498613|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20mg tid orally
498614|NCT00359736|O1|Outcome|Sildenafil|Sildenafil 20 mg tid orally
498615|NCT00359736|O2|Outcome|Placebo|Identical Placebo 20 mg tid
498616|NCT00359736|O1|Outcome|Sildenafil|"Sildenafil 20 mg tid~sildenafil: Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients."
498617|NCT00359736|E2|Reported Event|Sildenafil|sildenafil : Assessing the possible therapeutic benefit of sildenafil on exercise tolerance in IPF patients.
498618|NCT00359736|E1|Reported Event|Placebo|Control group
498619|NCT00359632|B3|Baseline|Total|Total of all reporting groups
498620|NCT00359632|B2|Baseline|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
498621|NCT00359632|B1|Baseline|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
498622|NCT00359632|P2|Participant Flow|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
498623|NCT00359632|P1|Participant Flow|Linezolid|Participants received linezolid either as tablets, by mouth (PO) or as an intravenous (IV) infusion at a dose of 600 milligrams (mg), twice daily (BID). Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
498624|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
498625|NCT00359632|O2|Outcome|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
498626|NCT00359632|O1|Outcome|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
498627|NCT00359632|E2|Reported Event|Control|Control participants individually matched to linezolid participants (on age, gender, and type of infection) received antibiotics other than linezolid per standard of care at the discretion of the treating investigator, for at least 6 weeks (at least 42 days). The control group was only assessed at the baseline visit to identify the presence of background abnormalities in the study test panel.
498628|NCT00359632|E1|Reported Event|Linezolid|Participants received linezolid either as tablets, PO or as an IV infusion at a dose of 600 mg, BID. Mode of administration and duration of treatment was at the discretion of the investigator, but for study purposes, the participant had to receive linezolid treatment for a minimum of 6 weeks (at least 42 days).
498629|NCT00359619|B8|Baseline|Total|Total of all reporting groups
498630|NCT00359619|B7|Baseline|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498631|NCT00359619|B6|Baseline|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498632|NCT00359619|B5|Baseline|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498633|NCT00359619|B4|Baseline|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498634|NCT00359619|B3|Baseline|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498635|NCT00359619|B2|Baseline|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498636|NCT00359619|B1|Baseline|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498637|NCT00359619|P7|Participant Flow|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498813|NCT00359281|P9|Participant Flow|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498638|NCT00359619|P6|Participant Flow|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498639|NCT00359619|P5|Participant Flow|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498640|NCT00359619|P4|Participant Flow|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498641|NCT00359619|P3|Participant Flow|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498642|NCT00359619|P2|Participant Flow|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498643|NCT00359619|P1|Participant Flow|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498644|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498645|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498646|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498647|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498648|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498649|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498650|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498651|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498652|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498653|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498654|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498655|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498656|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498657|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498658|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498659|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498660|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498661|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498662|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498929|NCT00358826|P7|Participant Flow|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
498663|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498664|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498665|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498666|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498667|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498668|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498669|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498670|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498671|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498672|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498673|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498674|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498675|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498676|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498677|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498678|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498679|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498680|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498681|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498682|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498683|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498684|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498685|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498686|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498687|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498688|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498689|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498690|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498691|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498692|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498693|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498694|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498695|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498696|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498697|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498698|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498699|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498700|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498701|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498702|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498703|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498704|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498705|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498706|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498707|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498708|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498709|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498710|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498711|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498712|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498713|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498714|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498715|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498716|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498717|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498718|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498719|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498720|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498721|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498722|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498723|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498724|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498725|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498726|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498727|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498728|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498729|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498730|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498731|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498732|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498733|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498734|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498735|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498736|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498737|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498738|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498739|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498740|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498741|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498742|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498743|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498744|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498745|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498746|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498747|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498748|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498749|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498750|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498751|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498752|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498753|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498754|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498755|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498756|NCT00359619|O7|Outcome|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498757|NCT00359619|O6|Outcome|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498758|NCT00359619|O5|Outcome|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498759|NCT00359619|O4|Outcome|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498760|NCT00359619|O3|Outcome|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498761|NCT00359619|O2|Outcome|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498762|NCT00359619|O1|Outcome|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498763|NCT00359619|E7|Reported Event|Cervarix 6 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 6 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498764|NCT00359619|E6|Reported Event|Cervarix 5 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 5 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498765|NCT00359619|E5|Reported Event|Cervarix 4 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 4 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498814|NCT00359281|P8|Participant Flow|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
498766|NCT00359619|E4|Reported Event|Cervarix 3 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 3 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498767|NCT00359619|E3|Reported Event|Cervarix 2 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 2 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498768|NCT00359619|E2|Reported Event|Cervarix 1 Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine formulation 1 at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498769|NCT00359619|E1|Reported Event|Cervarix Group|Female subjects, aged 18 to 25 years at the time of first vaccination, received 3 doses of Cervarix vaccine at Months 0, 1 and 6. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
498770|NCT00359424|B3|Baseline|Total|Total of all reporting groups
498771|NCT00359424|B2|Baseline|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498772|NCT00359424|B1|Baseline|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498773|NCT00359424|P2|Participant Flow|IV Rt-PA Alone|IV rt-PA alone (group one) received the standard dose (.9mg per kilogram with 10% as a bolus and the remainder as an infusion over 1 hour -maximum dose 90mg) of intravenous (IV) rt-PA alone.
498774|NCT00359424|P1|Participant Flow|Endovascular Therapy|Endovascular therapy (group two) received a lower dose (0.09mg per kg bolus and 0.54mg/kilogram infusion over 40 minutes, maximum dose 53.6mg) or after Amendment #5, a standard dose of IV rt-PA (.9mg/kg with 10% as a bolus and the remainder over one hour) and then underwent an angiogram test (cerebral angiography) right after the medicine was given to check for blood clots. If a clot was not seen, then no more treatment was given. If a clot was seen, the neurointerventionalist chose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that would be most effective in reopening the blocked artery.
498775|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498776|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498777|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498778|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498779|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498780|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498781|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498782|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498783|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498784|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498785|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498786|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498787|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498815|NCT00359281|P7|Participant Flow|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
499007|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
498788|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498789|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498790|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498791|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498792|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498793|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498794|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498795|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498796|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498797|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498798|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498799|NCT00359424|O2|Outcome|IV Rt-PA Alone|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498800|NCT00359424|O1|Outcome|Endovascular Therapy|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) right after the medicine is given to check for blood clots. If a clot is not seen then no more treatment will be given. If a clot is seen, the neurointerventionalist will then choose (based on the location and extent of the blood clot) a protocol approved endovascular treatment given directly in the brain artery that will be most effective in reopening the blocked artery.
498801|NCT00359424|E2|Reported Event|IV Only|Group one will receive the standard dose of intravenous (IV) rt-PA alone given over an hour.
498802|NCT00359424|E1|Reported Event|Endovascular|Group two will receive a lower dose or a standard dose of IV rt-PA and then undergo an angiogram test (cerebral angiography) rightafter the medicine is given to check for blood clots. If a clot is not seenthen no more treatment will be given. If a clot is seen, theneurointerventionalist will then choose (based on the location andextent of the blood clot) a protocol approved endovascular treatmentgiven directly in the brain artery that will be most effective inreopening the blocked artery.
498803|NCT00359281|B10|Baseline|Total|Total of all reporting groups
498804|NCT00359281|B9|Baseline|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498805|NCT00359281|B8|Baseline|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
498806|NCT00359281|B7|Baseline|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
498807|NCT00359281|B6|Baseline|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
498808|NCT00359281|B5|Baseline|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
498809|NCT00359281|B4|Baseline|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
498810|NCT00359281|B3|Baseline|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
498811|NCT00359281|B2|Baseline|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498812|NCT00359281|B1|Baseline|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
498925|NCT00358826|B3|Baseline|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498816|NCT00359281|P6|Participant Flow|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
498817|NCT00359281|P5|Participant Flow|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
498818|NCT00359281|P4|Participant Flow|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
498819|NCT00359281|P3|Participant Flow|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
498820|NCT00359281|P2|Participant Flow|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498821|NCT00359281|P1|Participant Flow|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
498822|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498823|NCT00359281|O1|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498824|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
498825|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
498826|NCT00359281|O1|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
498827|NCT00359281|O1|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
498828|NCT00359281|O1|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
498829|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498830|NCT00359281|O1|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498831|NCT00359281|O9|Outcome|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498832|NCT00359281|O8|Outcome|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
498833|NCT00359281|O7|Outcome|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
498834|NCT00359281|O6|Outcome|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
498835|NCT00359281|O5|Outcome|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
498836|NCT00359281|O4|Outcome|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
498837|NCT00359281|O3|Outcome|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
498838|NCT00359281|O2|Outcome|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498839|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
498840|NCT00359281|O1|Outcome|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
498841|NCT00359281|E9|Reported Event|ER Niacin 1000 mg + Lomitapide 10 mg|One dose oral ER Niacin 1000 mg, Lomitapide 60 mg once daily 6 days then one dose oral ER Niacin 1000 mg and Lomitapide 60 mg
498842|NCT00359281|E8|Reported Event|Dextrometh-rophan 30 mg + Lomitapide 60 mg|One dose oral Dextrometh-rophan 30 mg, Lomitapide 60 mg once daily 6 days then one dose oral Dextrometh-rophan 30 mg and Lomitapide 60 mg
498843|NCT00359281|E7|Reported Event|Rosuvastatin 20 mg + Lomitapide 60 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 60 mg
498844|NCT00359281|E6|Reported Event|Atorvastatin 20 mg + Lomitapide 60 mg|One dose oral Atorvastatin 20 mg, Lomitapide 60 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 60 mg
498845|NCT00359281|E5|Reported Event|Fenofibrate 145 mg + Lomitapide 10 mg|One dose oral micronized Fenofibrate 145 mg, Lomitapide 10 mg once daily 6 days then one dose oral micronized Fenofibrate 145 mg and Lomitapide 10 mg
498846|NCT00359281|E4|Reported Event|Rosuvastatin 20 mg + Lomitapide 10 mg|One dose oral Rosuvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Rosuvastatin 20 mg and Lomitapide 10 mg
498847|NCT00359281|E3|Reported Event|Ezetimibe 10 mg + Lomitapide 10 mg|One dose oral Ezetimibe 10 mg, Lomitapide 10 mg once daily 6 days then one dose oral Ezetimibe 10 mg and Lomitapide 10 mg
498848|NCT00359281|E2|Reported Event|Simvastatin 20 mg + Lomitapide 10 mg|One dose oral Simvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Simvastatin 20 mg and Lomitapide 10 mg
498849|NCT00359281|E1|Reported Event|Atorvastatin 20 mg + Lomitapide 10 mg|One dose oral Atorvastatin 20 mg, Lomitapide 10 mg once daily 6 days then one dose oral Atorvastatin 20 mg and Lomitapide 10 mg
498850|NCT00359216|B3|Baseline|Total|Total of all reporting groups
498926|NCT00358826|B2|Baseline|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498851|NCT00359216|B2|Baseline|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
498852|NCT00359216|B1|Baseline|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
498853|NCT00359216|P2|Participant Flow|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
498854|NCT00359216|P1|Participant Flow|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
498855|NCT00359216|O2|Outcome|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
498856|NCT00359216|O1|Outcome|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
498857|NCT00359216|E2|Reported Event|Placebo Nasal Spray|The placebo nasal spray was identical in appearance to the active MFNS. The composition was identical to the commercial formulation, an aqueous suspension without the active ingredient (mometasone furoate monohydrate). The administration was identical to MFNS.
498858|NCT00359216|E1|Reported Event|Mometasone Furoate Nasal Spray|100 mg of suspension provided 50 mg of mometasone furoate monohydrate. Subjects were instructed to administer 2 sprays into each nostril every morning. The total dosage of 4 sprays (2 per nostril) thus provided 200 mg daily to subjects receiving active drug. Treatment was to be administered for a nominal period of 28 days, to a maximum of 32 days.
498859|NCT00359203|B3|Baseline|Total|Total of all reporting groups
498860|NCT00359203|B2|Baseline|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
498861|NCT00359203|B1|Baseline|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
498862|NCT00359203|P2|Participant Flow|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
498863|NCT00359203|P1|Participant Flow|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
498864|NCT00359203|O2|Outcome|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
498865|NCT00359203|O1|Outcome|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
498866|NCT00359203|E2|Reported Event|Dual Chamber Pacemeker ON|Implant dual chamber pacemaker programmed ON and with Rate Drope Response algorhythm programmed ON
498867|NCT00359203|E1|Reported Event|Dual Chamber Pacemaker OFF|Implant dual chamber pacemaker programmed ODO (switched OFF)
498868|NCT00359138|B4|Baseline|Total|Total of all reporting groups
498869|NCT00359138|B3|Baseline|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498870|NCT00359138|B2|Baseline|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498871|NCT00359138|B1|Baseline|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498872|NCT00359138|P3|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498873|NCT00359138|P2|Participant Flow|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498874|NCT00359138|P1|Participant Flow|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498875|NCT00359138|O3|Outcome|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498876|NCT00359138|O2|Outcome|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498877|NCT00359138|O1|Outcome|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498878|NCT00359138|E3|Reported Event|Desloratadine Placebo Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498879|NCT00359138|E2|Reported Event|Desloratadine Placebo Tablet + Levocetirizine 5 mg Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498880|NCT00359138|E1|Reported Event|Desloratadine 5 mg Tablet + Levocetirizine Placebo Capsule|Subject was instructed to take 1 tablet and 1 capsule, once daily from day one (visit 3) to day 8 (visit 4).
498881|NCT00359021|B3|Baseline|Total|Total of all reporting groups
498882|NCT00359021|B2|Baseline|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498927|NCT00358826|B1|Baseline|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
508978|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
498883|NCT00359021|B1|Baseline|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498884|NCT00359021|P2|Participant Flow|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498885|NCT00359021|P1|Participant Flow|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498886|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498887|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498888|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498889|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498890|NCT00359021|O3|Outcome|All Participants|DUET Placebo + DUET TMC125
498891|NCT00359021|O2|Outcome|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498892|NCT00359021|O1|Outcome|DUET PLACEBO|Participants who received Placebo in a previous DUET study received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498893|NCT00359021|E3|Reported Event|All Participants|Participants who received placebo or TMC125 in a previous DUET study (DUET Placebo + DUET TMC125).
498894|NCT00359021|E2|Reported Event|DUET TMC125|Participants who received etravirine, also known as TMC125 (ETR) in a previous DUET study and received open-label treatment with 200 mg twice daily ETR and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-experienced participants.
498895|NCT00359021|E1|Reported Event|DUET PLACEBO|Participants who received Placebo in a previous DUET study and received open-label treatment with 200 mg twice daily etravirine, also known as TMC125 (ETR) and 600/100 mg twice daily darunavir (DRV)/low-dose ritonavir (rtv) were referred to as ETR-naïve participants.
498896|NCT00358956|B1|Baseline|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498897|NCT00358956|P1|Participant Flow|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498898|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498899|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498900|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498901|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498902|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498903|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498904|NCT00358956|O1|Outcome|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498905|NCT00358956|E1|Reported Event|ZD6474 (ZACTIMA™) 100 mg|ZD6474 (ZACTIMA™)100 mg daily
498906|NCT00358917|B3|Baseline|Total|Total of all reporting groups
498907|NCT00358917|B2|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498908|NCT00358917|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498909|NCT00358917|P2|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 milligram (mg) twice daily (BID) tablet
498910|NCT00358917|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 milligram (mg) once daily (QD) tablet
498911|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498912|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498913|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet; 81% NNRTI-experienced, 45% PI-experienced (20% nelfinavir, 17% indinavir, 13% atazanavir).
498914|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet; 88% NNRTI-experienced, 47% PI-experienced (24% nelfinavir, 19% indinavir, 13% atazanavir).
498915|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498916|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498917|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498918|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498919|NCT00358917|O2|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498920|NCT00358917|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498921|NCT00358917|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
498922|NCT00358917|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
498923|NCT00358826|B5|Baseline|Total|Total of all reporting groups
498924|NCT00358826|B4|Baseline|Placebo|Matching Placebo, oral dosing, 12 weeks
498930|NCT00358826|P6|Participant Flow|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
498931|NCT00358826|P5|Participant Flow|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
498932|NCT00358826|P4|Participant Flow|Placebo|Matching Placebo, 12 weeks
498933|NCT00358826|P3|Participant Flow|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498934|NCT00358826|P2|Participant Flow|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498935|NCT00358826|P1|Participant Flow|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498936|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
498937|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498938|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498939|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498940|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
498941|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498942|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498943|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498944|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
498945|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
498946|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
498947|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
498948|NCT00358826|O4|Outcome|Placebo MDCT Substudy|Matching Placebo, oral dosing, 24 weeks
498949|NCT00358826|O3|Outcome|VIA-2291 100 mg MDCT Substudy|VIA-2291, 100 mg, oral dosing, daily, 24 weeks
498950|NCT00358826|O2|Outcome|VIA-2291 50 mg MDCT Substudy|VIA-2291, 50 mg, oral dosing, daily, 24 weeks
498951|NCT00358826|O1|Outcome|VIA-2291 25 mg MDCT Substudy|VIA-2291, 25 mg, oral dosing, daily, 24 weeks
498952|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
498953|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498954|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498955|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498956|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
498957|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498958|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498959|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498960|NCT00358826|O4|Outcome|Placebo|Matching Placebo, oral dosing, 12 weeks
498961|NCT00358826|O3|Outcome|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498962|NCT00358826|O2|Outcome|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498963|NCT00358826|O1|Outcome|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498964|NCT00358826|E4|Reported Event|Placebo|Matching Placebo, oral dosing, 12 weeks
498965|NCT00358826|E3|Reported Event|VIA-2291 100 mg|VIA-2291, 100 mg, oral dosing, daily, 12 weeks
498966|NCT00358826|E2|Reported Event|VIA-2291 50 mg|VIA-2291, 50 mg, oral dosing, daily, 12 weeks
498967|NCT00358826|E1|Reported Event|VIA-2291 25 mg|VIA-2291, 25 mg, oral dosing, daily, 12 weeks
498968|NCT00358735|B3|Baseline|Total|Total of all reporting groups
498969|NCT00358735|B2|Baseline|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498970|NCT00358735|B1|Baseline|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498971|NCT00358735|P2|Participant Flow|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498972|NCT00358735|P1|Participant Flow|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498973|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498974|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498975|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498976|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498977|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498978|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
509191|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
498979|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498980|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498981|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498982|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498983|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498984|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498985|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498986|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498987|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498988|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498989|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498990|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498991|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498992|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498993|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498994|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498995|NCT00358735|O2|Outcome|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498996|NCT00358735|O1|Outcome|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498997|NCT00358735|E2|Reported Event|LMWH (Enoxaparin) (Active Comparator)|Enoxaparin (LMWH) was used, following a protocol that is considered a standard of care for this patient population. 30mg twice a day was given in the hospital and 40mg QD for the remainder of the 10 days (out of hospital).
498998|NCT00358735|E1|Reported Event|ActiveCare+SFT (Experimental)|The ActiveCare+SFT device is a mobile compression device used to prevent venous thromboembolic events. It was started immediately after the induction of anesthesia, throughout the surgery and for 10-12 days after surgery (in and out hospital).
498999|NCT00358670|B3|Baseline|Total|Total of all reporting groups
499000|NCT00358670|B2|Baseline|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499001|NCT00358670|B1|Baseline|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499002|NCT00358670|P2|Participant Flow|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in Psoriasis Area and Severity Index (PASI) from the Study P04271 (NCT00251641) Baseline
499003|NCT00358670|P1|Participant Flow|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499004|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499005|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499006|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499008|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499009|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499010|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499011|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499012|NCT00358670|O2|Outcome|Intermittent Infliximab|Infliximab 5 mg/kg by body weight at Weeks 0, 2, 6 and 14 following a 50% reduction in PASI from the Study P04271 (NCT00251641) Baseline
499013|NCT00358670|O1|Outcome|Maintenance Infliximab|Infliximab 5 mg/kg by body weight every 8 weeks
499014|NCT00358670|E2|Reported Event|Intermittent Infliximab|
499015|NCT00358670|E1|Reported Event|Maintenance Infliximab|
499016|NCT00358644|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
499017|NCT00358644|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
499018|NCT00358644|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
499019|NCT00358644|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 Intravenous on Days 1-5 of each 28 day cycle
499020|NCT00358579|B3|Baseline|Total|Total of all reporting groups
499021|NCT00358579|B2|Baseline|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499022|NCT00358579|B1|Baseline|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499023|NCT00358579|P2|Participant Flow|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499024|NCT00358579|P1|Participant Flow|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499025|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499026|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499027|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499028|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499029|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499030|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499031|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499032|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499033|NCT00358579|O2|Outcome|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499034|NCT00358579|O1|Outcome|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499035|NCT00358579|E2|Reported Event|Vasopressin|40 IU Intravenous Vasopressin, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499036|NCT00358579|E1|Reported Event|Adrenaline|1 mg Intravenous Adrenaline, administered as the first drug upon cardiac arrest patient's arrival at the Emergency Department
499037|NCT00358527|B3|Baseline|Total|Total of all reporting groups
499038|NCT00358527|B2|Baseline|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
499039|NCT00358527|B1|Baseline|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
499040|NCT00358527|P2|Participant Flow|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
499041|NCT00358527|P1|Participant Flow|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
499042|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
499043|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
499044|NCT00358527|O2|Outcome|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
499045|NCT00358527|O1|Outcome|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
499046|NCT00358527|E2|Reported Event|Placebo Nasal Spray.|Matching placebo nasal spray. Two sprays per nostril once daily, for 28 days.
499047|NCT00358527|E1|Reported Event|Mometasone Furoate Nasal Spray|Mometasone Furoate Nasal Spray; 50 mcg/spray: self-administered, two sprays per nostril (ie, 200 mcg), once daily (each morning), for 28 days.
499048|NCT00358501|B3|Baseline|Total|Total of all reporting groups
499049|NCT00358501|B2|Baseline|Historical Control|The control group was selected from the historical medical charts of patients undergoing hematopoietic stem cell transplant (HSCT).
499050|NCT00358501|B1|Baseline|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499051|NCT00358501|P2|Participant Flow|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
499185|NCT00358436|P1|Participant Flow|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499052|NCT00358501|P1|Participant Flow|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499053|NCT00358501|O1|Outcome|Historical Control|
499054|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
499055|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499056|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
499057|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499058|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
499059|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499060|NCT00358501|O2|Outcome|Historical Control|The control group was selected from the historical medical charts of patients undergoing HSCT.
499061|NCT00358501|O1|Outcome|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499062|NCT00358501|E2|Reported Event|Historical Control|
499063|NCT00358501|E1|Reported Event|Defibrotide|"Defibrotide treatment~Defibrotide: Defibrotide 6.25 mg/kg i.v. administered four times a day via 2 hour continuous infusion. Minimum duration 21 days."
499064|NCT00358462|B3|Baseline|Total|Total of all reporting groups
499065|NCT00358462|B2|Baseline|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
499066|NCT00358462|B1|Baseline|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
499067|NCT00358462|P2|Participant Flow|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
499068|NCT00358462|P1|Participant Flow|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
499069|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
499070|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
499071|NCT00358462|O2|Outcome|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
499072|NCT00358462|O1|Outcome|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
499073|NCT00358462|E2|Reported Event|Active Doxycycline + Placebo Azithromycin|Doxycycline : one 100mg capsule administered twice daily for seven days
499074|NCT00358462|E1|Reported Event|Active Azithromycin + Placebo Doxycycline|Azithromycin : two 500mg tablets or four 250mg tablets administered as a single dose
499075|NCT00358449|B4|Baseline|Total|Total of all reporting groups
499076|NCT00358449|B3|Baseline|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499077|NCT00358449|B2|Baseline|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499078|NCT00358449|B1|Baseline|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
499079|NCT00358449|P3|Participant Flow|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499080|NCT00358449|P2|Participant Flow|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499081|NCT00358449|P1|Participant Flow|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
499082|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499083|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499084|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499085|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499086|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499087|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499088|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499089|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499090|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499091|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499092|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499093|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499094|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499095|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499186|NCT00358436|O2|Outcome|Placebo|Once daily administered via inhalation
499096|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499097|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499098|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499099|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499100|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499101|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499102|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499103|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499104|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499105|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499106|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499107|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499108|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499109|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499110|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499111|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499112|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499113|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499114|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499115|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499116|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499117|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499118|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499119|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499120|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499121|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499122|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499123|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499124|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499125|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499126|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499127|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499128|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499129|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499130|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499131|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499132|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499133|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499134|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499135|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499136|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499137|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499138|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499139|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
510550|NCT00321919|B3|Baseline|Total|Total of all reporting groups
499140|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499141|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499142|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499143|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499144|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499145|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499146|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499147|NCT00358449|O1|Outcome|Mepolizumab 0.55/ 2.5/ 10 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499148|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499149|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499150|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499151|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499152|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499153|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499154|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499155|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499156|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499157|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499158|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499159|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499160|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499161|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499162|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499163|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499164|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499165|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499166|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499167|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499168|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499169|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499170|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499171|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499172|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499173|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499174|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499175|NCT00358449|O3|Outcome|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499176|NCT00358449|O2|Outcome|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499177|NCT00358449|O1|Outcome|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
499178|NCT00358449|E3|Reported Event|Mepolizumab 10 mg/kg|Participants received mepolizumab 10 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499179|NCT00358449|E2|Reported Event|Mepolizumab 2.5 mg/kg|Participants received mepolizumab 2.5 mg/kg by IV infusion for 30 minutes on Day 1, Week 4 and Week 8.
499180|NCT00358449|E1|Reported Event|Mepolizumab 0.55 mg/kg|Participants received mepolizumab 0.55 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion for 30 minutes on Day 1, Week 4 and Week 8.
499181|NCT00358436|B3|Baseline|Total|Total of all reporting groups
499182|NCT00358436|B2|Baseline|Placebo|Placebo by inhalation
499183|NCT00358436|B1|Baseline|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499184|NCT00358436|P2|Participant Flow|Placebo|Placebo by inhalation
499646|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499187|NCT00358436|O1|Outcome|Aclidinium 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499188|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
499189|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499190|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
499191|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499192|NCT00358436|O2|Outcome|Placebo|Placebo by inhalation
499193|NCT00358436|O1|Outcome|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499194|NCT00358436|E2|Reported Event|Placebo|Placebo by inhalation
499195|NCT00358436|E1|Reported Event|Aclidinium Bromide 200 μg Once-daily|Aclidinium bromide 200 μg once-daily by inhalation
499196|NCT00358332|B5|Baseline|Total|Total of all reporting groups
499197|NCT00358332|B4|Baseline|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499198|NCT00358332|B3|Baseline|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499199|NCT00358332|B2|Baseline|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499200|NCT00358332|B1|Baseline|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499201|NCT00358332|P4|Participant Flow|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499202|NCT00358332|P3|Participant Flow|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499203|NCT00358332|P2|Participant Flow|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499204|NCT00358332|P1|Participant Flow|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499205|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499206|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499207|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499208|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499209|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499210|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499211|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499212|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499213|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499214|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499215|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499216|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499217|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499218|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499219|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499220|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499221|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499222|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499223|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499291|NCT00358150|E1|Reported Event|Eliglustat 50 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg BID from Day 2 to Year 9.
499224|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499225|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499226|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499227|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499228|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499229|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499230|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499231|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499232|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499233|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499234|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499235|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499236|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499237|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499238|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499239|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499240|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499241|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499242|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499243|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499244|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499245|NCT00358332|O4|Outcome|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499246|NCT00358332|O3|Outcome|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499247|NCT00358332|O2|Outcome|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499248|NCT00358332|O1|Outcome|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499249|NCT00358332|E4|Reported Event|RabAvert(R)|Subjects received RabAvert(R) rabies vaccine by intramuscular injection in the deltoid at study days 0, 30 and 60.
499250|NCT00358332|E3|Reported Event|FMP2.1/AS02A 50 Mcg|Subjects received FMP2.1/AS02A 50 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499251|NCT00358332|E2|Reported Event|FMP2.1/AS02A 25 Mcg|Subjects received FMP2.1/AS02A 25 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499252|NCT00358332|E1|Reported Event|FMP2.1/AS02A 10 Mcg|Subjects received FMP2.1/AS02A 10 mcg (Falciparum Malaria Protein 2.1 / Adjuvant System 2 of GlaxoSmithKline Biologicals without thimerosal) by intramuscular injection in the deltoid at study days 0, 30 and 60.
499253|NCT00358215|B3|Baseline|Total|Total of all reporting groups
499254|NCT00358215|B2|Baseline|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499255|NCT00358215|B1|Baseline|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499292|NCT00358007|B1|Baseline|Cone Beam CT|Undergo a cone beam CT scan
499293|NCT00358007|P1|Participant Flow|Cone Beam CT|Undergo a cone beam CT scan
499256|NCT00358215|P2|Participant Flow|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499257|NCT00358215|P1|Participant Flow|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499258|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499259|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499260|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499261|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499262|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499263|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499264|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499265|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499266|NCT00358215|O2|Outcome|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499267|NCT00358215|O1|Outcome|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499268|NCT00358215|E2|Reported Event|Darbepoetin Alfa|Starting dose of 0.75 µg/kg subcutaneously every 2 weeks until hemoglobin concentrations reach 13.0 g/dL on 2 consecutive visits, then monthly dosing, titrated to achieve hemoglobin target of 13.0 g/dL, not to exceed 14.5 g/dL.
499269|NCT00358215|E1|Reported Event|Placebo|Participants received dose and administration schedule (every 2 weeks or once a month) changes that simulated the changes for participants receiving darbepoetin alfa.
499270|NCT00358150|B1|Baseline|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499271|NCT00358150|P1|Participant Flow|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 milligram (mg) dose on Day 1 then eliglustat 50 mg twice daily (BID) from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 nanogram per milliliter [ng/mL] on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme), and if all other causes for lack of treatment effect had been evaluated and ruled out).
499272|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499273|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499294|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
499274|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 8. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499275|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499276|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499277|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499278|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499279|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499280|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499281|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499282|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499283|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499284|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499285|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499286|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499287|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499288|NCT00358150|O1|Outcome|Eliglustat|Eliglustat (Genz-112638) capsule as single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID (if Genz-99067 [active moiety of eliglustat in plasma] trough plasma concentration was greater than or equal to [>=] 5 ng/mL on Day 10) or eliglustat 100 mg BID (if Genz-99067 trough plasma concentration was less than [<] 5 ng/mL), from day 20 to Year 4. After primary completion date (Week 52) participants underwent treatment interruption period of approximately 2 weeks before continuing the same treatment up to Year 9. Participant receiving 100 mg BID could be considered for a further dose increase to 150 mg BID at Week 24 if they met certain criteria (for example, had been on treatment for at least 24 months, had not reached therapeutic goals established for participants receiving Cerezyme, and if all other causes for lack of treatment effect had been evaluated and ruled out).
499289|NCT00358150|E3|Reported Event|Eliglustat|Participants who received eliglustat capsule as a single 50 mg dose on Day 1 then eliglustat 50 mg BID from Day 2 to Day 19, and then either eliglustat 50 mg BID or eliglustat 100 mg BID from Day 20 to Year 9. Participants who discontinued prior to Day 20 dose had their dose group set to missing and are only included in the all participants group. The Eliglustat group contains all participants who were treated with Eliglustat, including 2 participants dosed with 50 mg QD and 1 participant dosed with 150 mg BID for majority of study. Participants who had dose adjustment will be presented in dose group they received for majority of study.
499290|NCT00358150|E2|Reported Event|Eliglustat 100 mg BID|Participants who received eliglustat capsule as single 50 mg dose on Day 1 followed by eliglustat 50 mg capsule BID from Day 2 to Day 19 and then eliglustat 100 mg capsule BID from Day 20 to Year 9.
499295|NCT00358007|O1|Outcome|Cone Beam CT|PTV Reduction: The margin around the area to be treated with radiation is decreased due the image guidance of the cone beam CT
499296|NCT00358007|E1|Reported Event|Cone Beam CT|Undergo a cone beam CT scan
499297|NCT00357994|B3|Baseline|Total|Total of all reporting groups
499298|NCT00357994|B2|Baseline|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499299|NCT00357994|B1|Baseline|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499300|NCT00357994|P2|Participant Flow|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499301|NCT00357994|P1|Participant Flow|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499302|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499303|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499304|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499305|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499306|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499307|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499308|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499309|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499310|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499311|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499312|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499313|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499314|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499315|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499316|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499402|NCT00357955|O2|Outcome|Usual Care|The standard of care to patients with type 2 diabetes is provided by primary care providers at the VA Medical Center through individual clinic visits. The frequency of these visits for patients with diabetes averages approximately 4 months.usual care
499317|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499318|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499319|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499320|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499321|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499322|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499323|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499324|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499325|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499326|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499327|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499328|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499329|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499330|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499331|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499332|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499333|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499334|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499335|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499336|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499337|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499338|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499339|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499340|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499341|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499342|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499343|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499344|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499345|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499346|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499347|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499348|NCT00357994|O2|Outcome|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499349|NCT00357994|O1|Outcome|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa monohydrate, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499350|NCT00357994|E2|Reported Event|Placebo Gel + Levodopa-Carbidopa Capsules|Participants were randomized to placebo intestinal gel and oral levodopa-carbidopa (levodopa, 100 mg and carbidopa, 25 mg) Immediate Release (IR) capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of placebo.
499351|NCT00357994|E1|Reported Event|LCIG + Placebo Capsules|Participants were randomized to Levodopa-Carbidopa Intestinal Gel (LCIG; levodopa, 20 mg/mL and carbidopa, 5 mg/mL) and placebo capsules. Participants received the percutaneous endoscopic gastrostomy with jejunal extension (PEG-J) procedure for gel administration of LCIG.
499352|NCT00357968|B3|Baseline|Total|Total of all reporting groups
499353|NCT00357968|B2|Baseline|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for 14 days. Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
499354|NCT00357968|B1|Baseline|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days. Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
499355|NCT00357968|P2|Participant Flow|Clopidogrel to Prasugrel|One time oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
499356|NCT00357968|P1|Participant Flow|Prasugrel to Clopidogrel|One time oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a once daily 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for 14 days (Treatment 1 Phase). Patients cross-over to a once daily 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days (Treatment 2 Phase).
499357|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499358|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499359|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
499360|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499361|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499362|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499363|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499364|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499365|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (52 from the first maintenance dose period and 51 from the second maintenance dose period).
499366|NCT00357968|O1|Outcome|Prasugrel|Includes the total number of evaluable samples from patients who received prasugrel in each maintenance dose period (50 from the first maintenance dose period and 50 from the second maintenance dose period)
499367|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499368|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499369|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
499370|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose
499371|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) prior to any maintenance dose.
499372|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499373|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
499374|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
499375|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499376|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499377|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
499378|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499379|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) for the next 14 days.
499437|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499647|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499380|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) for the next 14 days.
499381|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499382|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499383|NCT00357968|O2|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally for the next 14 days.
499384|NCT00357968|O1|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days. Patients crossed over to a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally for the next 14 days.
499385|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 150-mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) taken orally once daily for 14 days.
499386|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by a 10-mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) taken orally once daily for 14 days.
499387|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499388|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499389|NCT00357968|O2|Outcome|Clopidogrel|Includes total number of evaluable samples from patients who received clopidogrel in each maintenance dose period (46 from the first maintenance dose period and 40 from the second maintenance dose period).
499390|NCT00357968|O1|Outcome|Prasugrel|Includes total number of evaluable samples from patients who received prasugrel in each maintenance dose period (40 in the first maintenance period and 45 in the second maintenance period).
499391|NCT00357968|O2|Outcome|Clopidogrel|Patients randomized to a single oral loading dose (LD) of 600-mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to the administration of any maintenance dose.
499392|NCT00357968|O1|Outcome|Prasugrel|Patients randomized to a single oral loading dose (LD) of 60-mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended), prior to administration of any maintenance dose.
499393|NCT00357968|E4|Reported Event|Clopidogrel After Cross-over|Clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days after cross-over from one time loading dose of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 10 mg prasugrel and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
499394|NCT00357968|E3|Reported Event|Prasugrel After Cross-over|Prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose)once daily for 14 days after cross-over from one time loading dose of clopidogrel 600 mg and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by clopidogrel 150 mg and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days
499395|NCT00357968|E2|Reported Event|Clopidogrel Before Cross-over|One time oral loading dose of 600 mg clopidogrel and placebo matched to prasugrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by 150 mg clopidogrel and placebo matched to prasugrel (clopidogrel maintenance dose) once daily for 14 days.
499396|NCT00357968|E1|Reported Event|Prasugrel Before Cross-over|One time oral loading dose (LD) of 60 mg prasugrel and placebo matched to clopidogrel (plus oral enteric coated aspirin 325 mg to 500 mg is recommended) followed by prasugrel 10 mg and placebo matched to clopidogrel (prasugrel maintenance dose) once daily for 14 days.
499397|NCT00357955|B3|Baseline|Total|Total of all reporting groups
499398|NCT00357955|B2|Baseline|Usual Care|usual care
499399|NCT00357955|B1|Baseline|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
499400|NCT00357955|P2|Participant Flow|Usual Care|usual care
499401|NCT00357955|P1|Participant Flow|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Pharmacologic case management : provided by clinical pharmacists following pre-established algorithms~Behavioral counseling and peer support : Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Role modeling : learning from peers with similar disease and problems~Interactive Education : interactive lectures with hands-on learning"
499648|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
511391|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
499403|NCT00357955|O1|Outcome|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
499404|NCT00357955|E2|Reported Event|Usual Care|usual care
499405|NCT00357955|E1|Reported Event|MEDIC|"Multidisciplinary education and diabetes intervention for cardiac risk reduction~Behavioral counseling and peer support: Multidisciplinary education and diabetes intervention for cardiac risk reduction - pharmacist led group intervention~Interactive Education: interactive lectures with hands-on learning~Role modeling: learning from peers with similar disease and problems~Pharmacologic case management: provided by clinical pharmacists following pre-established algorithms"
499406|NCT00357903|B3|Baseline|Total|Total of all reporting groups
499407|NCT00357903|B2|Baseline|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499408|NCT00357903|B1|Baseline|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499409|NCT00357903|P2|Participant Flow|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499410|NCT00357903|P1|Participant Flow|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499411|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499412|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499413|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499414|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499415|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499416|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499417|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499418|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499419|NCT00357903|O1|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499420|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499421|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499422|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499423|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499424|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499425|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499426|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499427|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499428|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499429|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499430|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499431|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499432|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499433|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499434|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499435|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499436|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499649|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499438|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499439|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499440|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499441|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499442|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499443|NCT00357903|O2|Outcome|Pediatric Participants|Pediatric participants with juvenile rheumatoid arthritis who received a maximum 50 mg dose of etanercept administered subcutaneously once weekly
499444|NCT00357903|O1|Outcome|Adult Participants|Adult participants with rheumatoid arthritis treated with a maximum etanercept dose of 50 mg administered subcutaneously once weekly
499445|NCT00357903|E2|Reported Event|Pediatric Subjects|
499446|NCT00357903|E1|Reported Event|Total Adults|
499447|NCT00357734|B1|Baseline|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499448|NCT00357734|P1|Participant Flow|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499449|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499450|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499451|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499452|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499453|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499454|NCT00357734|O1|Outcome|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499455|NCT00357734|E1|Reported Event|Gefitinib (ZD1839)|ZD1839 at a daily dose of 250 mg or 500 mg depending on final dose in parent trial
499456|NCT00357552|B1|Baseline|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499457|NCT00357552|P1|Participant Flow|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499458|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499459|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499460|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499461|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen. The study is ongoing. Results from entry to week 24 are posted. They will be updated upon completion of study duration of 104 weeks.
499462|NCT00357552|O1|Outcome|Virologic Failures by Week 24.|Subjects who met virologic failure criteria by week 24, for whom a sequence could be obtained.
499463|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499464|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499465|NCT00357552|O1|Outcome|All Screened Subjects With Available Sequences|All screened individuals, for whom a sequence could be obtained, regardless of whether they enrolled or not.
499466|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499467|NCT00357552|O1|Outcome|LPV/r Monotherapy|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499468|NCT00357552|E1|Reported Event|LPV/r|Participants will receive lopinavir/ritonavir twice daily for up to 104 weeks. Upon confirmation of virologic failure, emtricitabine (FTC)/tenofovir (TDF) once a day will be added to their regimen.
499469|NCT00357500|B1|Baseline|5-drug Metronmic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499486|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499470|NCT00357500|P1|Participant Flow|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499471|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499472|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499473|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499474|NCT00357500|O1|Outcome|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499475|NCT00357500|E1|Reported Event|5-drug Metronomic Antiangiogenic Regimen|Thalidomide: Start at 3 mg/kg (rounded to nearest 50 mg), increasing dose weekly by 50 mg as tolerated to 24 mg/kg (max 1,000 mg); Celecoxib: < 20 kg at 100 mg; 20-50 kg at 200 mg; > 50 kg at 400 mg; Fenofibrate: 90 mg/m2 (max 200 mg); Etoposide: 50 mg/m2; Cyclophosphamide: 2.5 mg/kg (max 100 mg); Patients receive oral etoposide once daily on days 1-21 and 43-63 (weeks 1-3 and 7-9) and oral cyclophosphamide once daily on days 22-42 (weeks 4-6). Patients also receive oral thalidomide once daily, oral celecoxib twice daily, and oral fenofibrate once daily in weeks 1-9. Treatment repeats approximately every 9 weeks for at least 3 courses in the absence of disease progression or unacceptable toxicity. Patients receive alternating etoposide and cyclophosphamide pulses (i.e., etoposide-cyclophosphamide-etoposide during courses 1 and 3 and cyclophosphamide-etoposide-cyclophosphamide during course 2).
499476|NCT00357396|B3|Baseline|Total|Total of all reporting groups
499477|NCT00357396|B2|Baseline|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
499478|NCT00357396|B1|Baseline|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
499479|NCT00357396|P2|Participant Flow|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
499480|NCT00357396|P1|Participant Flow|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
499481|NCT00357396|O1|Outcome|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
499482|NCT00357396|E2|Reported Event|Related Donors|Any consenting healthy family donor who is HLA compatible with the recipient will be considered as a potential donor for transplant
499483|NCT00357396|E1|Reported Event|Patients With HIGH RISK EWING'S SARCOMA FAMILY TUMOR|MELPHALAN & THIOTEPA TREATMENT OF HIGH RISK EWING'S SARCOMA FAMILY TUMOR
499484|NCT00357162|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499485|NCT00357162|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499487|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499488|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499489|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499490|NCT00357162|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499491|NCT00357162|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
499492|NCT00357110|B3|Baseline|Total|Total of all reporting groups
499493|NCT00357110|B2|Baseline|Anastrozole|anastrozole 1 mg
499494|NCT00357110|B1|Baseline|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
499495|NCT00357110|P2|Participant Flow|Anastrozole|anastrozole 1 mg
499496|NCT00357110|P1|Participant Flow|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
499497|NCT00357110|O2|Outcome|Anastrozole|anastrozole 1 mg
499498|NCT00357110|O1|Outcome|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
499499|NCT00357110|E2|Reported Event|Anastrozole|anastrozole 1 mg
499500|NCT00357110|E1|Reported Event|Fulvestrant + Anastrozole|fulvestrant 500 mg + anastrozole 1 mg
499501|NCT00357097|B3|Baseline|Total|Total of all reporting groups
499502|NCT00357097|B2|Baseline|Placebo|Subjects who took no investigational product.
499503|NCT00357097|B1|Baseline|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499504|NCT00357097|P2|Participant Flow|Placebo|Subjects who took no investigational product.
499505|NCT00357097|P1|Participant Flow|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499506|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499507|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499508|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499509|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499510|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499511|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499512|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499513|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499514|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499515|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499516|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499517|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499518|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499519|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499520|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499521|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499522|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499523|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499524|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499525|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499526|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499527|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499528|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499529|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499530|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499531|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499532|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499533|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499534|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499535|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499536|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499537|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499538|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499539|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499540|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499541|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499542|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499543|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499544|NCT00357097|O2|Outcome|Placebo|Subjects who took no investigational product.
499545|NCT00357097|O1|Outcome|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499546|NCT00357097|E2|Reported Event|Placebo|Subjects who took no investigational product.
499547|NCT00357097|E1|Reported Event|Ropinirole|Subjects who were treated on day 1-2 with 0.25 mg/day of ropinirole and on days 3-7 0.5 mg for 12 weeks if tolerated. After two weeks, dose could be increased weekly by 0.5mg a day up to 4 mg maximum dose.
499548|NCT00357032|B1|Baseline|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
499549|NCT00357032|P1|Participant Flow|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
499550|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
499551|NCT00357032|O1|Outcome|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
499552|NCT00357032|E1|Reported Event|Treatment (Belinostat)|"Patients receive PXD101 IV over 30 minutes on days 1-5. Treatment repeats every 21 days for 6-12 months in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV~laboratory biomarker analysis: Correlative studies"
499553|NCT00357006|B4|Baseline|Total|Total of all reporting groups
499554|NCT00357006|B3|Baseline|Placebo|
499555|NCT00357006|B2|Baseline|Adjunctive 100 mcg Transdermal Estradiol|
499556|NCT00357006|B1|Baseline|Adjunctive 200 mcg Transdermal Estradiol|
499557|NCT00357006|P3|Participant Flow|Placebo|Participants received daily transdermal placebo for 56 days.
499558|NCT00357006|P2|Participant Flow|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 56 days.
499559|NCT00357006|P1|Participant Flow|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 56 days.
499560|NCT00357006|O3|Outcome|Placebo|Participants received daily transdermal placebo for 56 days.
499561|NCT00357006|O2|Outcome|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100 mcg transdermal estradiol for 56 days.
499562|NCT00357006|O1|Outcome|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200 mcg transdermal estradiol for 56 days.
499563|NCT00357006|E3|Reported Event|Placebo|Participants received daily transdermal placebo for 8 weeks (56 days).
499564|NCT00357006|E2|Reported Event|Adjunctive 100 mcg Transdermal Estradiol|Participants received daily 100mcg transdermal estradiol for 8 weeks (56 days).
499565|NCT00357006|E1|Reported Event|Adjunctive 200 mcg Transdermal Estradiol|Participants received daily 200mcg transdermal estradiol for 8 weeks (56 days).
499566|NCT00356915|B4|Baseline|Total|Total of all reporting groups
499567|NCT00356915|B3|Baseline|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
499568|NCT00356915|B2|Baseline|Itraconazole Capsules|Itraconazole 100 mg capsules
499569|NCT00356915|B1|Baseline|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
499570|NCT00356915|P3|Participant Flow|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
499571|NCT00356915|P2|Participant Flow|Itraconazole Capsules|Itraconazole 100 mg capsules
499644|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
511392|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
499572|NCT00356915|P1|Participant Flow|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
499573|NCT00356915|O2|Outcome|Placebo Tablets|
499574|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
499575|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100mg capsules
499576|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
499577|NCT00356915|O3|Outcome|Placebo Tablets|Tablets that were the same as the Itraconazole tables except that they did not contain the active drug (Itraconazole).
499578|NCT00356915|O2|Outcome|Itraconazole Capsules|Itraconazole 100 mg capsules
499579|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200 mg tablets. Subjects took one 200 mg tablet once per day after a full meal. The last dose was taken the day before the Week 12 visit.
499580|NCT00356915|O2|Outcome|Placebo Tablets|
499581|NCT00356915|O1|Outcome|Itraconazole Tablets|Itraconazole 200mg tablets
499582|NCT00356915|E6|Reported Event|Placebo Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
499583|NCT00356915|E5|Reported Event|Itraconazole Capsules - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
499584|NCT00356915|E4|Reported Event|Itraconazole Tablets - Follow-up Period|Adverse events that occurred during the follow-up (no treatment) period are reported here.
499585|NCT00356915|E3|Reported Event|Placebo Tablets|Adverse events that occurred during the Treatment Period are reported here.
499586|NCT00356915|E2|Reported Event|Itraconazole Capsules|Itraconazole 100mg capsules Adverse events that occurred during the Treatment Period are reported here.
499587|NCT00356915|E1|Reported Event|Itraconazole Tablets - Treatment Period|Itraconazole 200mg tablets Adverse events that occurred during the Treatment Period are reported here.
499588|NCT00356889|B1|Baseline|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
499589|NCT00356889|P1|Participant Flow|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
499590|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
499591|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|"Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.~Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels."
499592|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
499593|NCT00356889|O1|Outcome|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression.
499594|NCT00356889|E1|Reported Event|Bevacizumab and Erlotinib Hydrochloride|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral erlotinib hydrochloride daily on days 1-28. Courses repeat every 28 days in the absence of unacceptable toxicity or disease progression. Tumor tissue and blood specimens are collected periodically for correlative studies. Specimens are examined by immunohistochemistry for epidermal growth factor receptor (EGFR) and P-EGFR protein levels; AKT p-AKT, mitogen-activated protein kinase (MAPK) and P-MAPK protein levels; and vascular endothelial growth factor receptor (VEGFR)-1 and VEGFR-2 protein levels. EGFR mutations are detected by laser capture microdissection. Enzyme-linked immunosorbent assay is used to measure total and free serum VEGF levels.
499595|NCT00356863|B3|Baseline|Total|Total of all reporting groups
499596|NCT00356863|B2|Baseline|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499597|NCT00356863|B1|Baseline|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499598|NCT00356863|P2|Participant Flow|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499599|NCT00356863|P1|Participant Flow|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499600|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499601|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499602|NCT00356863|O2|Outcome|No Education (Control) About Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499603|NCT00356863|O1|Outcome|Educational (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499604|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499605|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499606|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499607|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499608|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499609|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499610|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499611|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499612|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499613|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499614|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499615|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499616|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499617|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499618|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499619|NCT00356863|O1|Outcome|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499620|NCT00356863|O2|Outcome|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about CR and were giving the usual care.
499621|NCT00356863|O1|Outcome|Education (Intervention) on Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499622|NCT00356863|E2|Reported Event|No Education (Control) Regarding Cardiac Rehabilitation (CR)|Cardiac patients undergoing coronary artery bypass grafting (CABG) surgery receive the usual care without being exposed to the educational intervention. The staff in the cardiothoracic units (surgeons and nurses) did not receive any information about cardiac rehabilitation (CR) and were giving the usual care.
499623|NCT00356863|E1|Reported Event|Education (Intervention) Regarding Cardiac Rehabilitation (CR)|Cardiac patients were encouraged to participate in cardiac rehabilitation (CR) following coronary artery bypass grafting (CABG) surgery. Medical staff in the operating cardiothoracic units (surgeons and nurses) were encouraged to refer patients to CR.
499624|NCT00356811|B1|Baseline|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499625|NCT00356811|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel, administered as a 1-hour intravenous (IV) infusion at a dose of 80 mg/meters squared (m^2) on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499626|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499627|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499628|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499629|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499630|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499631|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499632|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499633|NCT00356811|O1|Outcome|Overall Study Arm|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499634|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499635|NCT00356811|O1|Outcome|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499636|NCT00356811|E1|Reported Event|Lapatinib Plus Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel, administered as a 1-hour IV infusion at a dose of 80 mg/m^2 on Days 1, 8, and 15 (±2 days) of a 28-day treatment cycle for at least 6 months. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
499637|NCT00356590|B1|Baseline|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499638|NCT00356590|P1|Participant Flow|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499639|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499640|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499641|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499642|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499643|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499650|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499651|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499652|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499653|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499654|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499655|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499656|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499657|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499658|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499659|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499660|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499661|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499662|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499663|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499664|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499665|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499666|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499667|NCT00356590|O1|Outcome|Etanercept (Enbrel)|Etanercept 50 mg subcutaneous dose weekly
499668|NCT00356590|E1|Reported Event|Enbrel|
499669|NCT00356525|B5|Baseline|Total|Total of all reporting groups
499670|NCT00356525|B4|Baseline|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499671|NCT00356525|B3|Baseline|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499672|NCT00356525|B2|Baseline|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499673|NCT00356525|B1|Baseline|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499674|NCT00356525|P4|Participant Flow|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499675|NCT00356525|P3|Participant Flow|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499676|NCT00356525|P2|Participant Flow|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499677|NCT00356525|P1|Participant Flow|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499678|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499679|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499680|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499681|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499682|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499683|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499684|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499685|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
511393|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
499686|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499687|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499688|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499689|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499690|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499691|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499692|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499693|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499694|NCT00356525|O4|Outcome|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499695|NCT00356525|O3|Outcome|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499696|NCT00356525|O2|Outcome|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499697|NCT00356525|O1|Outcome|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499698|NCT00356525|E4|Reported Event|One Year or Greater: Pemetrexed + Gemcitabine|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499699|NCT00356525|E3|Reported Event|One Year or Greater: Pemetrexed + Carboplatin|Disease relapse at one year or greater after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression Carboplatin: Area under the curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles or until disease progression
499700|NCT00356525|E2|Reported Event|Less Than One Year: Pemetrexed + Gemcitabine|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days x 6 cycles or until disease progression Gemcitabine: 1500 mg/m2, IV, every 14 days x 6 cycles or until disease progression
499701|NCT00356525|E1|Reported Event|Less Than One Year: Pemetrexed|Disease relapse at less than one year after neoadjuvant/adjuvant chemotherapy. Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 6 cycles or until disease progression
499702|NCT00356421|B3|Baseline|Total|Total of all reporting groups
499703|NCT00356421|B2|Baseline|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499704|NCT00356421|B1|Baseline|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499705|NCT00356421|P2|Participant Flow|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499706|NCT00356421|P1|Participant Flow|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499707|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499708|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499709|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499710|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499711|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499712|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499713|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499714|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499715|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499716|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499717|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499718|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499719|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499720|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499721|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499722|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499723|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499724|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499725|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499726|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499727|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499728|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499729|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499730|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499731|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499732|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499733|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499734|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499735|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499736|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499737|NCT00356421|O2|Outcome|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499738|NCT00356421|O1|Outcome|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499739|NCT00356421|E2|Reported Event|Insulin Lispro|Subcutaneous (SC) insulin regimen of pre-prandial insulin lispro and QD administration of insulin glargine.
499740|NCT00356421|E1|Reported Event|Exubera ®|Preprandial inhaled insulin regimen plus once daily (QD) administration of insulin glargine.
499741|NCT00356408|B5|Baseline|Total|Total of all reporting groups
499742|NCT00356408|B4|Baseline|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499743|NCT00356408|B3|Baseline|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499744|NCT00356408|B2|Baseline|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499745|NCT00356408|B1|Baseline|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499746|NCT00356408|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
499747|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499748|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499749|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499750|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499751|NCT00356408|O4|Outcome|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499752|NCT00356408|O3|Outcome|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499753|NCT00356408|O2|Outcome|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499754|NCT00356408|O1|Outcome|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Regardless of their remission status and steroids use, they have participated to the week 38 visit of C87059.
499813|NCT00356200|B1|Baseline|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
511394|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
499755|NCT00356408|E5|Reported Event|CDP870 400 mg (Overall)|Certolizumab pegol (CDP870) 400 mg (2 injections of 1 mL) every 4 weeks from Week 2 until Week 34, or until CDP870 is available for a Crohn’s disease indication in the patient’s country. Subjects who were Non-completers of C87059 (COSPAR I, NCT00349752) receive an additional CDP870 400 mg dose at Week 2
499756|NCT00356408|E4|Reported Event|CDP870/Non-completer|CDP870 Non-completer: CDP870 subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499757|NCT00356408|E3|Reported Event|Placebo/Non-completer|Placebo Non-completer: Placebo subjects who left C87059 early because of failure (relapse/treatment failure or not tolerating the Corticosteroids tapering/needing reintroduction of Corticosteroids).
499758|NCT00356408|E2|Reported Event|CDP870/Completer|CDP870 Completer: CDP870 subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
499759|NCT00356408|E1|Reported Event|Placebo/Completer|Placebo Completer: Placebo subjects who completed C87059. Whatever their remission status and steroids use, they have participated to the week 38 visit of C87059.
499760|NCT00356304|B3|Baseline|Total|Total of all reporting groups
499761|NCT00356304|B2|Baseline|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
499762|NCT00356304|B1|Baseline|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
499763|NCT00356304|P2|Participant Flow|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
499764|NCT00356304|P1|Participant Flow|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
499765|NCT00356304|O2|Outcome|Treatment as Usual|
499766|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
499767|NCT00356304|O2|Outcome|Treatment as Usual|
499768|NCT00356304|O1|Outcome|Motivational Enhancement Therapy for Antidepressants|
499769|NCT00356304|E2|Reported Event|Treatment as Usual|Participants in this condition received usual care provided at the bilingual division of the CMHC. This included medication management, as well as some psychotherapy treatment. All aspects of care for participants in TAU was naturalistic and determined by CMHC psychiatrists and therapists who were not part of the study.
499770|NCT00356304|E1|Reported Event|Motivational Enhancement Therapy for Antidepressants|Participants in this condition received TAU that was enhanced with three sessions of META. Two sessions were provided between the time 1 and time 2 evaluations, with a booster session occurring between the time 2 and time 3 evaluations. These participants were also receiving psychopharmacologic/psychotherapeutic care that was naturalistic.
499771|NCT00356278|B4|Baseline|Total|Total of all reporting groups
499772|NCT00356278|B3|Baseline|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499773|NCT00356278|B2|Baseline|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499774|NCT00356278|B1|Baseline|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499775|NCT00356278|P3|Participant Flow|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499776|NCT00356278|P2|Participant Flow|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499777|NCT00356278|P1|Participant Flow|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499778|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
500870|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
499779|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499780|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499781|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499782|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499783|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499784|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499785|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499786|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499787|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499788|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499789|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499790|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499791|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499792|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499793|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499794|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499814|NCT00356200|P2|Participant Flow|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
499916|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499795|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499796|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499797|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499798|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499799|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499800|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499801|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499802|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499803|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499804|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499805|NCT00356278|O3|Outcome|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499806|NCT00356278|O2|Outcome|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499807|NCT00356278|O1|Outcome|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499808|NCT00356278|E3|Reported Event|VRE Therapy and Placebo|"Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display.~Placebo: Placebo will be administered in the same manner as the active drugs."
499809|NCT00356278|E2|Reported Event|VRE Therapy and Alprazolam|"Alprazolam: Alprazolam doses will be 0.25 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499810|NCT00356278|E1|Reported Event|VRE Therapy and D-cycloserine|"D-Cycloserine: D-Cycloserine doses will be 50 mg. There will be 5 pills total during study, each given 30 minutes prior to each VRE session.~Virtual Reality Exposure Therapy: VRE includes viewing scenes of virtual Iraq via a head mounted display. Other stimuli presented include sounds, smells and vibration. Each session will be 60 minutes with approximately 30 to 45 minutes of that wearing head mounted display."
499811|NCT00356200|B3|Baseline|Total|Total of all reporting groups
499812|NCT00356200|B2|Baseline|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
499815|NCT00356200|P1|Participant Flow|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body.
499816|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|Cohort 2 lesion treated with placebo
499817|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|Cohort 2 100 ug/ml Fluphenazine decanoate treated lesion
499818|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|Cohort 1 lesion treated with placebo
499819|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|Cohort 1 10 ug/ml Fluphenazine decanoate treated lesion
499820|NCT00356200|O4|Outcome|Cohort 2, Placebo Treated Lesion|lesion treated with placebo (Cohort 2)
499821|NCT00356200|O3|Outcome|Cohort 2, 100 ug/ml Fluphenazine Treated Lesion|lesion receiving 100 ug/ml Fluphenazine decanoate (Cohort 2)
499822|NCT00356200|O2|Outcome|Cohort 1, Placebo Treated Lesion|lesion treated with placebo (Cohort 1)
499823|NCT00356200|O1|Outcome|Cohort 1, 10 ug/ml Fluphenazine Treated Lesion|lesion receiving 10 ug/ml Fluphenazine decanoate (Cohort 1)
499824|NCT00356200|E2|Reported Event|Cohort 2: 100 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (100 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
499825|NCT00356200|E1|Reported Event|Cohort 1: 10 ug/ml Fluphenazine Decanoate|Receiving fluphenazine decanoate (10 ug/ml) in a target lesion on one side of the body and placebo in a lesion on the other side of the body
499826|NCT00356148|B3|Baseline|Total|Total of all reporting groups
499827|NCT00356148|B2|Baseline|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
499828|NCT00356148|B1|Baseline|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
499829|NCT00356148|P2|Participant Flow|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
499830|NCT00356148|P1|Participant Flow|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
499831|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receiving antibiotic prophylaxis
499832|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
499833|NCT00356148|O2|Outcome|No Prophylaxis Group|Patients who are BMI over 25 and not receive antibiotic prophylaxis
499834|NCT00356148|O1|Outcome|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
499835|NCT00356148|E2|Reported Event|No Prophylaxis Group|Patients who are BMI over 25 and do not receive antibiotic prophylaxis
499836|NCT00356148|E1|Reported Event|Prophylaxis Group|patients who are BMI over 25 and receiving ampicillin/sulbactam prophylaxis
499837|NCT00356135|B4|Baseline|Total|Total of all reporting groups
499838|NCT00356135|B3|Baseline|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499839|NCT00356135|B2|Baseline|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499840|NCT00356135|B1|Baseline|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499841|NCT00356135|P3|Participant Flow|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499842|NCT00356135|P2|Participant Flow|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499843|NCT00356135|P1|Participant Flow|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499844|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499845|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499846|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499847|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499848|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499849|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499850|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499851|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499914|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499852|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499853|NCT00356135|O2|Outcome|No Clopidogrel Use|Patients with no clopidogrel use at the time of qualifying ACS event.
499854|NCT00356135|O1|Outcome|Clopidogrel Use|Patients with clopidogrel use at the time of qualifying ACS event.
499855|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499856|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499857|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499858|NCT00356135|O3|Outcome|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499859|NCT00356135|O2|Outcome|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomization to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499860|NCT00356135|O1|Outcome|Prasugrel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomization to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499861|NCT00356135|E3|Reported Event|Prasugrel 60/10 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 60 mg and placebo followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499862|NCT00356135|E2|Reported Event|Clopidogrel 75/75 mg|Open label dose of clopidogrel 75 mg for 10 to 14 days. Upon completion, randomized to a single loading dose of clopidogrel 75 mg and placebo, followed by maintenance dose of clopidogrel 75 mg taken for 13 to 15 days.
499863|NCT00356135|E1|Reported Event|Prasgurel 10/10 mg|Open label dose of clopidogrel 75 milligram (mg) for 10 to 14 days. Upon completion, randomized to a single loading dose of prasugrel 10 mg and placebo, followed by maintenance dose of prasugrel 10 mg taken for 13 to 15 days.
499864|NCT00356122|B1|Baseline|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499865|NCT00356122|P1|Participant Flow|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499866|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499867|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499868|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499869|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499870|NCT00356122|O1|Outcome|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499871|NCT00356122|E1|Reported Event|Docetaxel/Oxaliplatin/Bevacizumab|"Participants with advanced, recurrent, or metastatic Non Small Cell Lung Cancer (NSCLC), treated with the combination of~70 mg/m^2 docetaxel intravenously on Day 1 for Cycles 1-6,~100 mg/m^2 oxaliplatin intravenously on Day 1 for Cycles 1-6,~15 mg/kg bevacizumab intravenously on Day 1 for Cycles 1-6 and every 3 weeks during maintenance therapy."
499872|NCT00356057|B4|Baseline|Total|Total of all reporting groups
499873|NCT00356057|B3|Baseline|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
499874|NCT00356057|B2|Baseline|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
499915|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
500040|NCT00355615|E5|Reported Event|Rosuva ol|rosuvastatin open label
499875|NCT00356057|B1|Baseline|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
499876|NCT00356057|P3|Participant Flow|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
499877|NCT00356057|P2|Participant Flow|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
499878|NCT00356057|P1|Participant Flow|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
499879|NCT00356057|O3|Outcome|RV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The device is programmed to right ventricular pacing only. The acceleromer is activated for rate adaptation.
499880|NCT00356057|O2|Outcome|biV Pacing With Accelerometer Based Rate Adaption (Stratos LV)|Patients are implanted with a Stratos LV device, with the atrial port plugged and the left ventricular port for the left ventricular lead and the right ventricular port for the right ventricular lead to provide biV pacing. The acceleromer is activated for rate adaptation.
499881|NCT00356057|O1|Outcome|biV-pacing With CLS Rate Adaption (Protos CLS)|Patients are implanted with a Protos CLS device, using the atrial port of the device for the left ventricular lead and the ventricular port for the ventricular lead to provide biV pacing. CLS is activated for rate adaptation.
499882|NCT00356057|E1|Reported Event|All Groups|
499883|NCT00355914|B3|Baseline|Total|Total of all reporting groups
499884|NCT00355914|B2|Baseline|Group II With Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic with steroids
499885|NCT00355914|B1|Baseline|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
499886|NCT00355914|P2|Participant Flow|Group II With Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and Steroids (0.15 mg of non-particulate betamethasone)
499887|NCT00355914|P1|Participant Flow|Group 1 Without Steroids|Lumbar Facet Joint block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
499888|NCT00355914|O2|Outcome|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
499889|NCT00355914|O1|Outcome|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
499890|NCT00355914|O2|Outcome|Group II|Local anesthetic with steroids
499891|NCT00355914|O1|Outcome|Group I|Local anesthetic without steroids
499892|NCT00355914|E2|Reported Event|Group II With Steroids|Facet Joint Nerve Blocks Local anesthetic with steroids
499893|NCT00355914|E1|Reported Event|Group 1 Without Steroids|Lumbar Facet Joint Nerve Blocks Local anesthetic without steroids
499894|NCT00355797|B4|Baseline|Total|Total of all reporting groups
499895|NCT00355797|B3|Baseline|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499896|NCT00355797|B2|Baseline|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499897|NCT00355797|B1|Baseline|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499898|NCT00355797|P3|Participant Flow|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499899|NCT00355797|P2|Participant Flow|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499900|NCT00355797|P1|Participant Flow|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499901|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499902|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499903|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499904|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499905|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499906|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499907|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499908|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499909|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499910|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499911|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499912|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499913|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499917|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499918|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499919|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499920|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499921|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499922|NCT00355797|O3|Outcome|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499923|NCT00355797|O2|Outcome|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499924|NCT00355797|O1|Outcome|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499925|NCT00355797|E3|Reported Event|No Rate Adaptive Pacing|Pacemaker programmed with no rate adaption (DDD) for long-term study follow-up.
499926|NCT00355797|E2|Reported Event|Standard Rate Adaptive Pacing|Pacemaker programmed with standard rate adaptive technology (R, accelerometer) for long-term study follow-up.
499927|NCT00355797|E1|Reported Event|CLS Rate Adaptive Pacing|Pacemaker programmed with Closed Loop Stimulation (CLS) rate adaptive technology for long-term study follow-up.
499928|NCT00355784|B4|Baseline|Total|Total of all reporting groups
499929|NCT00355784|B3|Baseline|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone.
499930|NCT00355784|B2|Baseline|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499931|NCT00355784|B1|Baseline|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499932|NCT00355784|P3|Participant Flow|High Growth Hormone Treatment|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499933|NCT00355784|P2|Participant Flow|Growth Hormone Treatment|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499934|NCT00355784|P1|Participant Flow|Control|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499935|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
499936|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499937|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499938|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
499939|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499940|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499941|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
499942|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499943|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
500041|NCT00355615|E4|Reported Event|Placebo|placebo
500042|NCT00355615|E3|Reported Event|Rosuva 20|rosuvastatin 20 mg
499944|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499945|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499946|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499947|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499948|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499949|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499950|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
499951|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499952|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499953|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499954|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499955|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499956|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|
499957|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499958|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499959|NCT00355784|O3|Outcome|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499960|NCT00355784|O2|Outcome|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499961|NCT00355784|O1|Outcome|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499962|NCT00355784|E3|Reported Event|High Growth Hormone Treatment (High-GHT)|5 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received a relatively high daily dose of growth hormone throughout the 2-week overeating period.
499963|NCT00355784|E2|Reported Event|Growth Hormone Treatment (GHT)|8 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and received exogenous growth hormone treatment administered in 4 daily injections to mimic physiological growth hormone secretion throughout the 2-week overeating period.
499964|NCT00355784|E1|Reported Event|Control (CON)|9 non-obese (initial body mass index 23.5 +/- 0.3 kg/m2), weight stable, relatively sedentary (physical activity </- 2h/week), healthy adults not taking any medications were admitted to the hospital for 2 weeks during which time they ate ~4000 kcal/day and their plasma growth hormone concentration was allowed to decline naturally.
499965|NCT00355706|B3|Baseline|Total|Total of all reporting groups
499966|NCT00355706|B2|Baseline|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
499967|NCT00355706|B1|Baseline|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
499968|NCT00355706|P2|Participant Flow|Group II - With Steroids|Group II - Thoracic medial branch blocks with bupivacaine and steroid
499969|NCT00355706|P1|Participant Flow|Group I - Without Steroids|Group I - Thoracic medial branch blocks with local anesthetics
499970|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
499971|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
499972|NCT00355706|O2|Outcome|Group II - With Steroids|Thoracic medial branch blocks with bupivacaine and steroid
499973|NCT00355706|O1|Outcome|Group I - Without Steroids|Thoracic medial branch blocks with local anesthetics
499974|NCT00355706|O2|Outcome|Group II With Steroid|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine) and Steroids (0.15 mg of non-particulate betamethasone)
499975|NCT00355706|O1|Outcome|Group I Without Steroids|Thoracic Facet Joint Nerve Blocks with Local Anesthetic (0.25% Bupivacaine)
499976|NCT00355706|E2|Reported Event|Group II - With Bupivacaine and Steroid|Group II - Thoracic medial branch blocks with bupivacaine and steroid
499977|NCT00355706|E1|Reported Event|Group I - With Local Anesthetics|Group I - Thoracic medial branch blocks with local anesthetics
499978|NCT00355615|B5|Baseline|Total|Total of all reporting groups
499979|NCT00355615|B4|Baseline|Placebo|placebo
499980|NCT00355615|B3|Baseline|Rosuva 20|rosuvastatin 20 mg
499981|NCT00355615|B2|Baseline|Rosuva 10|rosuvastatin 10 mg
499982|NCT00355615|B1|Baseline|Rosuva 5|rosuvastatin 5 mg
499983|NCT00355615|P5|Participant Flow|Rosuva ol|rosuvastatin open label
499984|NCT00355615|P4|Participant Flow|Placebo|placebo
499985|NCT00355615|P3|Participant Flow|Rosuva 20|rosuvastatin 20 mg
499986|NCT00355615|P2|Participant Flow|Rosuva 10|rosuvastatin 10 mg
499987|NCT00355615|P1|Participant Flow|Rosuva 5|rosuvastatin 5 mg
499988|NCT00355615|O4|Outcome|Placebo|placebo
499989|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
499990|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
499991|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
499992|NCT00355615|O4|Outcome|Placebo|placebo
499993|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
499994|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
499995|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
499996|NCT00355615|O4|Outcome|Placebo|placebo
499997|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
499998|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
499999|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500000|NCT00355615|O4|Outcome|Placebo|placebo
500001|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500002|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500003|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500004|NCT00355615|O4|Outcome|Placebo|placebo
500005|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500006|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500007|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500008|NCT00355615|O4|Outcome|Placebo|placebo
500009|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500010|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500011|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500012|NCT00355615|O4|Outcome|Placebo|placebo
500013|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500014|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500015|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500016|NCT00355615|O4|Outcome|Placebo|placebo
500017|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500018|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500019|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500020|NCT00355615|O4|Outcome|Placebo|placebo
500021|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500022|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500023|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500024|NCT00355615|O4|Outcome|Placebo|placebo
500025|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500026|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500027|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500028|NCT00355615|O4|Outcome|Placebo|placebo
500029|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500030|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500031|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500032|NCT00355615|O4|Outcome|Placebo|placebo
500033|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500034|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500035|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500036|NCT00355615|O4|Outcome|Placebo|placebo
500037|NCT00355615|O3|Outcome|Rosuva 20|rosuvastatin 20 mg
500038|NCT00355615|O2|Outcome|Rosuva 10|rosuvastatin 10 mg
500039|NCT00355615|O1|Outcome|Rosuva 5|rosuvastatin 5 mg
500045|NCT00355472|B1|Baseline|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
500046|NCT00355472|P1|Participant Flow|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CC chemokine 4 receptor (CCR4) positive Adult T-Cell Leukemia-Lymphoma (ATL) or CCR4 positive Peripheral T-Cell Lymphoma (PTCL)
500047|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL.
500048|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
500049|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
500050|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
500051|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
500052|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
500053|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
500054|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
500055|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
500056|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
500057|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
500058|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
500059|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
500060|NCT00355472|O4|Outcome|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
500061|NCT00355472|O3|Outcome|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
500062|NCT00355472|O2|Outcome|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
500063|NCT00355472|O1|Outcome|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
500064|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
500065|NCT00355472|O1|Outcome|KW-0761|KW-0761 was administered 4 times at one-week intervals at a dose of 0.01, 0.1, 0.5 or 1.0 mg/kg in patients with CCR4 positive ATL or CCR4 positive PTCL
500066|NCT00355472|E4|Reported Event|KW-0761 1.0mg|IV infusions of KW-0761 once/week for 4 weeks
500067|NCT00355472|E3|Reported Event|KW-0761 0.5mg|IV infusions of KW-0761 once/week for 4 weeks
500068|NCT00355472|E2|Reported Event|KW-0761 0.1mg|IV infusions of KW-0761 once/week for 4 weeks
500069|NCT00355472|E1|Reported Event|KW-0761 0.01mg|IV infusions of KW-0761 once/week for 4 weeks
500070|NCT00355394|B3|Baseline|Total|Total of all reporting groups
500071|NCT00355394|B2|Baseline|Metoclopramide|Metoclopramide group received standard care including IVF AND metoclopramide.
500072|NCT00355394|B1|Baseline|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500073|NCT00355394|P2|Participant Flow|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500074|NCT00355394|P1|Participant Flow|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500075|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500076|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500077|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500078|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500079|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500080|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500081|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500082|NCT00355394|O1|Outcome|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500083|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
500084|NCT00355394|O1|Outcome|Placebo|Placebo
500085|NCT00355394|O2|Outcome|Metoclopramide|Metoclopramide
500086|NCT00355394|O1|Outcome|Placebo|Placebo
500087|NCT00355394|E2|Reported Event|Metoclopramide|Metoclopramide group received standard care including IVF and also IV metoclopramide.
500088|NCT00355394|E1|Reported Event|Placebo|Placebo group received standard care including IVF but not metoclopramide.
500089|NCT00355368|B3|Baseline|Total|Total of all reporting groups
500090|NCT00355368|B2|Baseline|Rocuronium|0.6mg/kg
500091|NCT00355368|B1|Baseline|Succinylcholine|1mg/kg
500092|NCT00355368|P2|Participant Flow|Rocuronium|0.6mg/kg
500093|NCT00355368|P1|Participant Flow|Succinylcholine|1mg/kg
500094|NCT00355368|O2|Outcome|Rocuronium|
500095|NCT00355368|O1|Outcome|Succinylcholine|
500096|NCT00355368|O2|Outcome|Rocuronium|
500097|NCT00355368|O1|Outcome|Succinylcholine|
500098|NCT00355368|O2|Outcome|Rocuronium|
500099|NCT00355368|O1|Outcome|Succinylcholine|
500100|NCT00355368|O2|Outcome|Rocuronium|
500101|NCT00355368|O1|Outcome|Succinylcholine|
500102|NCT00355368|E2|Reported Event|Rocuronium|0.6mg/kg
500103|NCT00355368|E1|Reported Event|Succinylcholine|1mg/kg
500104|NCT00355147|B3|Baseline|Total|Total of all reporting groups
500105|NCT00355147|B2|Baseline|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500128|NCT00355134|P4|Participant Flow|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500342|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500106|NCT00355147|B1|Baseline|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
500107|NCT00355147|P2|Participant Flow|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
500108|NCT00355147|P1|Participant Flow|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
500109|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500110|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/Transcient Ischemic Attack"
500111|NCT00355147|O2|Outcome|Arm 2 Control Group|Received usual care, follow up telephone calls to control for contact, and educational materials
500112|NCT00355147|O1|Outcome|Arm 1 Stroke Prevention Intervention|Randomized to receive the intervention which included receipt of stroke prevention and self management intervention and stroke peer support.
500113|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500114|NCT00355147|O1|Outcome|Arm 1 Secondary Risk Factor Management|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support and Physician Stroke Guideline Adherence~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Stroke Self Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
500115|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500116|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
500117|NCT00355147|O2|Outcome|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500118|NCT00355147|O1|Outcome|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
500119|NCT00355147|E2|Reported Event|Attention Control Group|Received Phone Calls from Staff to Control for Attention
500120|NCT00355147|E1|Reported Event|Arm 1 Stroke Self Management and Risk Factor Program|"Patient Secondary Stroke Risk Factor Program including Stroke Self Management and Stroke Peer Support~Physician stroke guideline adherence: Provided clinicians with Secondary Stroke Prevention Guidelines/Posted near workstations for Discharge Planning and Provided Clinicians with Seminar on Motivational Interviewing and Goal Setting to Modify Patient Health Behaviors~Secondary Stroke Self-Management and Risk Factor Management: Provided Post Stroke Guidelines on Secondary Prevention to Clinicians Preparing Discharge Plans; Provided Secondary Stroke Self-Management and Stroke Peer Support to Veteran Patients with Stroke/TIA"
500121|NCT00355134|B6|Baseline|Total|Total of all reporting groups
500122|NCT00355134|B5|Baseline|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
500123|NCT00355134|B4|Baseline|Extension: Fingolimod 1.25 mg|Participants who had received placebo in the Core phase and then received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500124|NCT00355134|B3|Baseline|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500125|NCT00355134|B2|Baseline|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500126|NCT00355134|B1|Baseline|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500127|NCT00355134|P5|Participant Flow|Extension: Fingolimod 0.5 mg|Participants who had received placebo in the Core phase and then received 0.5 mg fingolimod orally once a day in the Extension phase.
500226|NCT00355082|E2|Reported Event|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
500129|NCT00355134|P3|Participant Flow|Placebo (Core)|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500130|NCT00355134|P2|Participant Flow|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500131|NCT00355134|P1|Participant Flow|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500132|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500133|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500134|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500135|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500136|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500137|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500138|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500139|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500140|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500141|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500142|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500143|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500144|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500145|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500146|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500147|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500148|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500227|NCT00355082|E1|Reported Event|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
500228|NCT00355030|B3|Baseline|Total|Total of all reporting groups
500149|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500150|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500151|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500152|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500153|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500154|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500155|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500156|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500157|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500158|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500159|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500160|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500161|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500162|NCT00355134|O3|Outcome|Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. In the Extension phase participants received either 1.25 or 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500163|NCT00355134|O2|Outcome|Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 0.5 mg fingolimod orally once a day.
500164|NCT00355134|O1|Outcome|Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. In the Extension phase participants continued to receive 1.25 mg fingolimod orally. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500165|NCT00355134|E5|Reported Event|Extension: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day in the Extension phase.
500166|NCT00355134|E4|Reported Event|Extension: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day in the Extension phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500167|NCT00355134|E3|Reported Event|Core: Placebo|Participants received placebo capsules orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking placebo were switched to 0.5 mg fingolimod orally once a day.
500168|NCT00355134|E2|Reported Event|Core: Fingolimod 0.5 mg|Participants received 0.5 mg fingolimod orally once a day for up to 24 months during the core phase.
500169|NCT00355134|E1|Reported Event|Core: Fingolimod 1.25 mg|Participants received 1.25 mg fingolimod orally once a day for up to 24 months during the core phase. Upon implementation of a protocol amendment, all patients taking 1.25 mg fingolimod were switched to 0.5 mg fingolimod orally once a day.
500170|NCT00355121|B4|Baseline|Total|Total of all reporting groups
500229|NCT00355030|B2|Baseline|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500501|NCT00353418|E2|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500171|NCT00355121|B3|Baseline|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500172|NCT00355121|B2|Baseline|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500173|NCT00355121|B1|Baseline|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500174|NCT00355121|P3|Participant Flow|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500175|NCT00355121|P2|Participant Flow|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500176|NCT00355121|P1|Participant Flow|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500177|NCT00355121|O3|Outcome|Group 3: DAPTACEL on Day 30 (Visit 2)|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500178|NCT00355121|O2|Outcome|Group 2: IPOL on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500179|NCT00355121|O1|Outcome|Group 1: Menactra on Day 30 (Visit 2)|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500180|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500181|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500182|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500183|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500184|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500185|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500186|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500187|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500188|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500189|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500190|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500502|NCT00353418|E1|Reported Event|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500191|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500192|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500193|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500194|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500195|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500196|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500197|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500198|NCT00355121|O3|Outcome|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500199|NCT00355121|O2|Outcome|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500200|NCT00355121|O1|Outcome|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500201|NCT00355121|E3|Reported Event|Group 3: Menactra + IPOL on Day 0 / DAPTACEL on Day 30|Participants who received single doses of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) diphtheria and poliovirus vaccine inactivated (IPOL) tetanus toxoids at Visit 1 and a single dose of acellular pertussis vaccine adsorbed (DAPTACEL) at Visit 2
500202|NCT00355121|E2|Reported Event|Group 2: DAPTACEL + Menactra on Day 0 / IPOL on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 1 and a single dose of poliovirus vaccine inactivated (IPOL) at Visit 2
500203|NCT00355121|E1|Reported Event|Group 1: DAPTACEL + IPOL on Day 0 / Menactra on Day 30|Participants who received single doses of diphtheria and tetanus toxoids and acellular pertussis vaccine adsorbed (DAPTACEL) and poliovirus vaccine inactivated (IPOL) at Visit 1 and a single dose of meningococcal polysaccharide diphtheria toxoid conjugate vaccine (Menactra) at Visit 2
500204|NCT00355082|B3|Baseline|Total|Total of all reporting groups
500205|NCT00355082|B2|Baseline|Treatment Phase: LTG XR, 250 mg|LTG XR, 250 mg/day in the Treatment phase
500206|NCT00355082|B1|Baseline|Treatment Phase: LTG XR, 300 mg|LTG XR, 300 mg/day in the Treatment phase
500207|NCT00355082|P3|Participant Flow|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
500208|NCT00355082|P2|Participant Flow|LTG XR, 250 mg|LTG XR, 250 mg/day
500209|NCT00355082|P1|Participant Flow|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day. In the Continuation phase, Treatment phase participants received LTG XR, 300 mg/day.
500210|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
500211|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
500212|NCT00355082|O2|Outcome|Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
500213|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|Treatment phase participants; LTG XR, 300 mg/day
500214|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
500215|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
500216|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
500217|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
500218|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
500219|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
500220|NCT00355082|O2|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
500221|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
500222|NCT00355082|O1|Outcome|LTG XR, 250 mg|LTG XR, 250 mg/day
500223|NCT00355082|O1|Outcome|Lamotrigine Extended-release (LTG XR), 300 mg|LTG XR, 300 mg/day
500224|NCT00355082|E4|Reported Event|Continuation Phase: Baseline Failures|Baseline failures that entered the Continuation Phase; LTG XR; 300 mg/day
500225|NCT00355082|E3|Reported Event|Continuation Phase: LTG XR, 300 mg|Treatment phase participants; LTG XR, 300 mg/day
500230|NCT00355030|B1|Baseline|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500231|NCT00355030|P2|Participant Flow|Somatropin: Experimental Arm 2|0.05mg/kg/day subcutaneous somatropin only
500232|NCT00355030|P1|Participant Flow|Somatropin and Leuprorelin: Experimental Arm 1|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500233|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500234|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500235|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500236|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500237|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500238|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500239|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500240|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500241|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500242|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500243|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500244|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500245|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500246|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500247|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500248|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500249|NCT00355030|O2|Outcome|Somatropin|0.05mg/kg/day subcutaneous somatropin only
500250|NCT00355030|O1|Outcome|Somatropin and Leuprorelin|0.05mg/kg/day subcutaneous somatropin and 3-month formulation, subcutaneous or intramuscular injection of 11.25mg leuprorelin for three years (or for a minimum of 2 years until a chronological age of 13 years for girls and 15 years for boys, whichever occurs first).
500251|NCT00355030|E2|Reported Event|Somatropin|Somatropin n=45
500252|NCT00355030|E1|Reported Event|Somatropin and Leuprorelin|Somatropin and leuprorelin n=46
500253|NCT00354978|B1|Baseline|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
500254|NCT00354978|P1|Participant Flow|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
500255|NCT00354978|O1|Outcome|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
500256|NCT00354978|E1|Reported Event|FOLFIRI Plus Bevacizumab|FOLFIRI [folinic acid (leucovorin) 400 mg/m^2 by vein (IV) Day 1; 5-FU 400 mg/m^2 IV injection Day 1 immediately followed by 2.4 g/m^2 IV over 46 hours over Days 1-3; Irinotecan 180 mg/m^2 IV on Day 1] + Bevacizumab 5 mg/kg over 90 minutes on Day 1 administered alone then 5 mg/kg IV on Day 1 of 14 day cycle.
500257|NCT00354913|B1|Baseline|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500258|NCT00354913|P1|Participant Flow|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500259|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500288|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
500260|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500261|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500262|NCT00354913|O1|Outcome|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500263|NCT00354913|E1|Reported Event|Imatinib Mesylate+Hydroxyurea|All patients receive imatinib mesylate and hydroxyurea orally on a daily, continuous basis. Dosing of imatinib mesylate is adjusted for patients who are also receiving p450-inducing anti-epileptic drugs.
500264|NCT00354887|B1|Baseline|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
500265|NCT00354887|P1|Participant Flow|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
500266|NCT00354887|O1|Outcome|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
500267|NCT00354887|E1|Reported Event|Oxaliplatin + Capecitabine|Intravenous Oxaliplatin 130 mg/m^2, Day 1 + Oral Capecitabine 750 mg/m^2 twice daily Days 1-14.
500268|NCT00354770|B3|Baseline|Total|Total of all reporting groups
500269|NCT00354770|B2|Baseline|Placebo|Placebo pills
500270|NCT00354770|B1|Baseline|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
500271|NCT00354770|P2|Participant Flow|Placebo|Placebo pills
500272|NCT00354770|P1|Participant Flow|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
500273|NCT00354770|O2|Outcome|Placebo|Placebo pills
500274|NCT00354770|O1|Outcome|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
500275|NCT00354770|E2|Reported Event|Placebo|Placebo pills
500276|NCT00354770|E1|Reported Event|N-Acetyl Cysteine|N-Acetyl Cysteine (NAC) - 1200mg-2400mg by mouth per day
500277|NCT00354744|B1|Baseline|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
500278|NCT00354744|P1|Participant Flow|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
500279|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Patients with parameningeal (without intracranial extension) and paraspinal tumors should receive chemotherapy beginning Week 1 and begin radiation therapy at Week 20. Weeks 1-6 vincristine sulfate (VCR) & irinotecan hydrochloride (IRIN), Weeks 7-34 vincristine sulfate (VCR), Cyclophosphamide (CPM) with MESNA, Doxorubicin hydrochloride (DOX), Etoposide (ETOP), Ifosfamide (IFOS) with MESNA. Weeks 35-54 vincristine sulfate (VCR), Dactinomycin (DACT) and Cyclophosphamide (CPM) with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
500280|NCT00354744|O1|Outcome|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients
500281|NCT00354744|E1|Reported Event|High_Risk_Rhabdomyosarcoma|Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
500282|NCT00354679|B1|Baseline|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
500283|NCT00354679|P1|Participant Flow|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
500284|NCT00354679|O1|Outcome|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
500285|NCT00354679|E1|Reported Event|Irinotecan, Cisplatin, Bevacizumab, Radiotherapy, & Surger|Irinotecan, Cisplatin, Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
500286|NCT00354640|B1|Baseline|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
500287|NCT00354640|P1|Participant Flow|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
500289|NCT00354640|O1|Outcome|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
500290|NCT00354640|E1|Reported Event|Anastrozole and Simvastatin|"adjuvant therapy : laboratory analysis~pharmacological study : laboratory analysis~simvastatin : 40 milligram tablet PO QD for 14 days~anastrozole : 1 milligram tablet PO QD for 14 days"
500291|NCT00354601|B1|Baseline|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500292|NCT00354601|P1|Participant Flow|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500293|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500294|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500295|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500296|NCT00354601|O1|Outcome|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500297|NCT00354601|E1|Reported Event|Docetaxel and Capecitabine|Docetaxel and Capecitabine therapy per protocol
500298|NCT00354484|B3|Baseline|Total|Total of all reporting groups
500299|NCT00354484|B2|Baseline|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
500300|NCT00354484|B1|Baseline|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
500301|NCT00354484|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
500302|NCT00354484|P1|Participant Flow|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
500303|NCT00354484|O2|Outcome|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
500304|NCT00354484|O1|Outcome|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
500305|NCT00354484|E2|Reported Event|Ferrous Sulfate Tablets|325 mg of ferrous sulfate 3 times daily (TID) x 6 weeks.
500306|NCT00354484|E1|Reported Event|Ferric Carboxymaltose (FCM)|Up to a maximum cumulative dose of 2,500 mg administered IV based on iron-deficit calculations; the calculated dose was given in divided doses of up to 1,000 mg weekly.
500307|NCT00354341|B3|Baseline|Total|Total of all reporting groups
500308|NCT00354341|B2|Baseline|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500309|NCT00354341|B1|Baseline|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500310|NCT00354341|P2|Participant Flow|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was less than (<) 10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500311|NCT00354341|P1|Participant Flow|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 International Units (IU) subcutaneously (SC) once weekly to reach and maintain target hemoglobin (Hb) between 13 and 15 grams per deciliter (g/dL), for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500312|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500313|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500314|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500315|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500316|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500341|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500928|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500317|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500318|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500319|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500320|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500321|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500322|NCT00354341|O2|Outcome|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500323|NCT00354341|O1|Outcome|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500324|NCT00354341|E2|Reported Event|Group 2 (No/Late Epoetin Beta)|Participants received their standard treatment for 15 months but no treatment for anemia correction unless Hb level was <10.5 g/dL on 2 consecutive visits of 2 weeks interval or the Hb level was <10 g/dL on a single determination. In such cases participants could receive epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain a target Hb level of 10.5 to 11.5 g/dL. Standard treatment was as per investigator discretion.
500325|NCT00354341|E1|Reported Event|Group 1 (Early Epoetin Beta)|Along with their standard treatment participants received epoetin beta at a starting dose of 2000 IU SC once weekly to reach and maintain target Hb between 13 and 15 g/dL, for 15 months. Epoetin beta doses were adjusted according to individual participant’s Hb level. Standard treatment was as per investigator discretion.
500326|NCT00354172|B1|Baseline|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500327|NCT00354172|P1|Participant Flow|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500328|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500329|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500330|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500331|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500332|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500333|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500334|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500335|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500336|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500337|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500338|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500339|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500340|NCT00354172|O1|Outcome|Evaluable Patients|All patients receiving full study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500503|NCT00353366|B1|Baseline|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500343|NCT00354172|E1|Reported Event|Patients Treated for Refractory Hematologic Cancers|All patients receiving at least partial study treatment with chemotherapy and radiation, along with natural killer cells, aldesleukin and umbilical cord blood transplant.
500344|NCT00354159|B3|Baseline|Total|Total of all reporting groups
500345|NCT00354159|B2|Baseline|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500346|NCT00354159|B1|Baseline|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500347|NCT00354159|P2|Participant Flow|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500348|NCT00354159|P1|Participant Flow|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500349|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500350|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500351|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500352|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500353|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
500354|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system
500355|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500356|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500357|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500358|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500359|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500360|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500361|NCT00354159|O2|Outcome|Heart Failure Event Control Subjects|Subjects randomized to the Control Arm that had a heart failure event during the 12-month randomized period
500362|NCT00354159|O1|Outcome|Heart Failure Event Free Control Subjects|Subjects randomized to the Control Arm that did not have a heart failure related event during the 12-month randomized period
500363|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500364|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500365|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500366|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500367|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500368|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500369|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500370|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500371|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500372|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500373|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
500374|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500375|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
500376|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500377|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
500378|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500379|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
500380|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500381|NCT00354159|O2|Outcome|Control Arm|Physicians do NOT have access to device-based hemodynamic monitor information to guide patient management
500382|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500383|NCT00354159|O2|Outcome|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500384|NCT00354159|O1|Outcome|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500385|NCT00354159|O1|Outcome|Chronicle IHM Implanted Subjects|Analysis cohort includes the one subject with a Chronicle IHM implant attempt
500386|NCT00354159|O1|Outcome|Chronicle ICD Implanted Subjects|Analysis cohort includes all 406 subjects with an attempted implant of the Chronicle ICD system.
500387|NCT00354159|E3|Reported Event|Enrolled, Not Randomized|42 subjects were enrolled but exited the study prior to randomization
501096|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
500388|NCT00354159|E2|Reported Event|Control Arm|Physicians do not have access to device-based hemodynamic monitor information to guide patient management
500389|NCT00354159|E1|Reported Event|Treatment Arm|Physicians have access to device-based hemodynamic monitor information to guide patient management
500390|NCT00354107|B1|Baseline|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
500391|NCT00354107|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
500392|NCT00354107|O1|Outcome|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
500393|NCT00354107|E1|Reported Event|Treatment (Monoclonal Antibody Therapy, Chemotherapy)|"Patients receive monoclonal antibody SGN-30 (dosage 12mg/kg) IV alone on day 1 in weeks 1-8. Beginning in week 5, patients receive ICE chemotherapy comprising ifosfamide IV (dosage 3g/m2) x 3 days over 2 hours on days 1-3, carboplatin IV (635mg/m2) over 1 hour on day 1, and etoposide IV (dosage 100/m2) over 1 hour on days 1-3. Treatment with ICE repeats every 3 weeks for 6 courses** in the absence of unacceptable toxicity. Patients also receive intrathecal therapy (dosage dependent on age) comprising methotrexate, cytarabine, and hydrocortisone once on day 29 (week 5).~Cohorts of 3-6 patients receive a pre-determined dose of monoclonal antibody SGN-30 with possible dose de-escalation to 1 dose level below (dosage 8mg/kg) in the event of ≥ 2 of 6 patients experience dose-limiting toxicity (DLT). The dose at which ≤ 1 of 6 patients experience DLT will be used in a phase II study."
500394|NCT00354029|B3|Baseline|Total|Total of all reporting groups
500395|NCT00354029|B2|Baseline|Placebo|
500396|NCT00354029|B1|Baseline|S (+) Ketamine|
500397|NCT00354029|P2|Participant Flow|Placebo|
500398|NCT00354029|P1|Participant Flow|S (+) Ketamine|
500399|NCT00354029|O2|Outcome|Placebo|
500400|NCT00354029|O1|Outcome|S (+) Ketamine|
500401|NCT00354029|E2|Reported Event|Placebo|
500402|NCT00354029|E1|Reported Event|S (+) Ketamine|
500403|NCT00353977|B1|Baseline|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
500404|NCT00353977|P1|Participant Flow|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
500405|NCT00353977|O1|Outcome|Alvac pp65 Vaccine|Subjects received 2 or 3 doses of the vaccine
500406|NCT00353977|E1|Reported Event|Alvac pp65 Vaccine|Subjects received 1, 2 or 3 doses of the vaccine
500407|NCT00353795|B1|Baseline|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
500408|NCT00353795|P1|Participant Flow|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
500409|NCT00353795|O1|Outcome|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
500410|NCT00353795|E1|Reported Event|Participants|Participants in the MESA trial (http://www.mesa-nhlbi.org/) randomly selected by the University of Washington Coordinating center who agreed to participate. Enrollment from October 2005 to February 2008
500411|NCT00353704|B3|Baseline|Total|Total of all reporting groups
500412|NCT00353704|B2|Baseline|Placebo|
500413|NCT00353704|B1|Baseline|Pregabalin|
500414|NCT00353704|P2|Participant Flow|Placebo|
500415|NCT00353704|P1|Participant Flow|Pregabalin|
500416|NCT00353704|O2|Outcome|Placebo|
500417|NCT00353704|O1|Outcome|Pregabalin|
500418|NCT00353704|O2|Outcome|Placebo|
500419|NCT00353704|O1|Outcome|Pregabalin|
500420|NCT00353704|E2|Reported Event|Placebo|
500421|NCT00353704|E1|Reported Event|Pregabalin|
500422|NCT00353652|B7|Baseline|Total|Total of all reporting groups
500423|NCT00353652|B6|Baseline|Spironolactone|Spironolactone: 25-75 mg taken orally, once daily
500424|NCT00353652|B5|Baseline|Chlorthalidone|Chlorthalidone: 12.5-25 mg taken orally, once daily
500425|NCT00353652|B4|Baseline|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
501097|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
500426|NCT00353652|B3|Baseline|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
500427|NCT00353652|B2|Baseline|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
500428|NCT00353652|B1|Baseline|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
500429|NCT00353652|P6|Participant Flow|Spironolactone|Spironolactone 25-75 mg taken orally daily
500430|NCT00353652|P5|Participant Flow|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
500431|NCT00353652|P4|Participant Flow|Irbesartan|"Drug: Irbesartan~150 mg taken orally, once daily"
500432|NCT00353652|P3|Participant Flow|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
500433|NCT00353652|P2|Participant Flow|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
500434|NCT00353652|P1|Participant Flow|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
500435|NCT00353652|O6|Outcome|Irbesartan|Irbesartan 150 mg taken orally once a day
500436|NCT00353652|O5|Outcome|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally
500437|NCT00353652|O4|Outcome|Spironolactone|Spironolactone 25-50 mg taken orally daily
500438|NCT00353652|O3|Outcome|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
500439|NCT00353652|O2|Outcome|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
500440|NCT00353652|O1|Outcome|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
500441|NCT00353652|E6|Reported Event|Spironolactone|Spironolactone 25-75 mg taken orally daily
500442|NCT00353652|E5|Reported Event|Chlorthalidone|Chlorthalidone 12.5-25 mg taken orally daily
500443|NCT00353652|E4|Reported Event|Irbesartan|Drug: Irbesartan 150 mg taken orally, once daily
500444|NCT00353652|E3|Reported Event|Chlorthalidone Plus Irbesartan|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Irbesartan: 150 mg taken orally, once daily"
500445|NCT00353652|E2|Reported Event|Chlorthalidone Plus Spironolactone|"Chlorthalidone: 12.5-25 mg taken orally, once daily~Spironolactone: 50-75 mg taken orally, once daily"
500446|NCT00353652|E1|Reported Event|Chlorthalidone Alone|Chlorthalidone: 12.5-25 mg taken orally, once daily
500447|NCT00353496|B3|Baseline|Total|Total of all reporting groups
500448|NCT00353496|B2|Baseline|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500449|NCT00353496|B1|Baseline|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500450|NCT00353496|P2|Participant Flow|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500451|NCT00353496|P1|Participant Flow|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500452|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500453|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500454|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500455|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500456|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500457|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500458|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500459|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500460|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500461|NCT00353496|O2|Outcome|Placebo|Placebo: Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500462|NCT00353496|O1|Outcome|Lanreotide (Autogel Formulation)|lanreotide (Autogel formulation): 120mg administered via deep subcutaneous injection every 28 days for a maximum period of 2 years.
500463|NCT00353496|E2|Reported Event|Placebo|Saline solution 0.9% administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500464|NCT00353496|E1|Reported Event|Lanreotide (Autogel Formulation)|120mg administered via deep subcutaneous injection every 28 days for a maximum period of 96 weeks.
500465|NCT00353431|B3|Baseline|Total|Total of all reporting groups
500466|NCT00353431|B2|Baseline|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500467|NCT00353431|B1|Baseline|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500504|NCT00353366|P1|Participant Flow|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500505|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500506|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500468|NCT00353431|P2|Participant Flow|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500469|NCT00353431|P1|Participant Flow|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500470|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500471|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500472|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500473|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500474|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500475|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500476|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500477|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500478|NCT00353431|O2|Outcome|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500479|NCT00353431|O1|Outcome|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500480|NCT00353431|E2|Reported Event|Intensive Insulin Therapy Algorithm|The algorithm in the intensive insulin group contains four insulin resistance factors, depending on baseline features of the patients and on the changes of plasma glucose levels after insulin administration. Every two to four hours the plasma glucose level is measured and Insulin aspart (Novorapid®) is injected s.c. according to the scheme. If the patient is eating, the dose of Insulin aspart (NovoRapid®)is increased according to the amount of carbohydrate intake.
500481|NCT00353431|E1|Reported Event|Conventional Insulin Group|In the conventional insulin group only the meal-glucose adapted sliding scale at beginning is pre-determined. All adaptations of the insulin sliding scale remain upon the discretion of the treating physician.
500482|NCT00353418|B3|Baseline|Total|Total of all reporting groups
500483|NCT00353418|B2|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500484|NCT00353418|B1|Baseline|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500485|NCT00353418|P2|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500486|NCT00353418|P1|Participant Flow|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500487|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500488|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500489|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500490|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500491|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500492|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500493|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500494|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500495|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500496|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500497|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500498|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500499|NCT00353418|O2|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 1000 or 1200 mg|
500500|NCT00353418|O1|Outcome|PEG-IFN Alfa-2a 180 μg + Ribavirin 800 mg|
500507|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500508|NCT00353366|O1|Outcome|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500509|NCT00353366|E1|Reported Event|Rotarix Group|Subjects received two oral doses of the Rotarix vaccine at the age of 6 weeks
500510|NCT00353301|B1|Baseline|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
500511|NCT00353301|P1|Participant Flow|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
500512|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
500513|NCT00353301|O1|Outcome|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
500514|NCT00353301|E1|Reported Event|Erlotinib and Sirolimus|Erlotinib (Tarceva) therapy was started at 150 mg by mouth daily from day 1 to be taken at least 1 hour before or 2 hours after a meal. Sirolimus was initiated on day 8 (D8) with a loading dose of 6mg by mouth, followed by a daily dose of 2mg by mouth, on the basis of the product prescribing information for low-to-moderate immunologic risk renal transplant patients.
500515|NCT00353275|B3|Baseline|Total|Total of all reporting groups
500516|NCT00353275|B2|Baseline|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
500517|NCT00353275|B1|Baseline|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
500518|NCT00353275|P2|Participant Flow|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
500519|NCT00353275|P1|Participant Flow|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
500520|NCT00353275|O2|Outcome|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
500521|NCT00353275|O1|Outcome|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
500522|NCT00353275|E2|Reported Event|Conventional Glycemic Control|Blood glucose target range is 110-140 mg/dL.
500523|NCT00353275|E1|Reported Event|Strict Glycemic Control|Blood glucose target range is 80-110 mg/dL.
500524|NCT00353262|B1|Baseline|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500525|NCT00353262|P1|Participant Flow|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500526|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500527|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500768|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500528|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500529|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500530|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500531|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500532|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500533|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500534|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500535|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500536|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500537|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500538|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500539|NCT00353262|O1|Outcome|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500540|NCT00353262|E1|Reported Event|Capecitabine+ Oxaliplatin+ Bevacizumab|In Cycle 1, participants received a single oral dose of capecitabine 1000 milligrams per meter square (mg/m^2 on Day 1 followed by 2-hour intravenous (IV) infusion of oxaliplatin 130 mg/m^2 on Day 2 followed by oral dosing of capecitabine 1000 mg/m^2 twice-daily (BID) from Day 5 to Day 14 . In Cycle 2, participants received IV infusion of oxaliplatin 130 mg//m^2 over 2 hours on Day 1 along with capecitabine 1000 mg/m^2 orally BID until Day 14. In Cycle 3, participants received IV infusion of bevacizumab 7.5 mg/kg over 90 minutes on Day 1 at the same time as oxaliplatin 130 mg//m^2 was administered as an IV infusion over 2 hours (Day 1 every 3 weeks) along with capecitabine1000 mg//m^2 orally BID until Day 14. Treatment with the Cycle 3 dosing regimen continued for a further 13 cycles (i.e. Cycle 16) or until progressive disease or unacceptable toxicity or until the participant withdrew consent
500541|NCT00352118|B1|Baseline|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500542|NCT00352118|P1|Participant Flow|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500543|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500544|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500545|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500546|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500547|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500548|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500549|NCT00352118|O1|Outcome|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500550|NCT00352118|E1|Reported Event|Chemotherapy + Low Dose Radiation|Patients receiving combination chemotherapy plus low dose radiation
500551|NCT00352105|B1|Baseline|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500552|NCT00352105|P1|Participant Flow|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500574|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500553|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500554|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500555|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500556|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500557|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500558|NCT00352105|O1|Outcome|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500559|NCT00352105|E1|Reported Event|5-FU, Cisplatin, Radiation and Iressa|Patients undergo hyperfractionated radiotherapy twice daily, 5 days a week, beginning on day 1 and continuing for 6 weeks. Patients also receive fluorouracil IN continuously over 96 hrs. and cisplatin IV continuously over 96 hrs. on days 1-3 and 22-25 and oral gefitinib beginning once daily on day 1 and continuing for up to 2 years in the absence of disease progression or unacceptable toxicity.
500560|NCT00352053|B3|Baseline|Total|Total of all reporting groups
500561|NCT00352053|B2|Baseline|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
500562|NCT00352053|B1|Baseline|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
500563|NCT00352053|P2|Participant Flow|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
500564|NCT00352053|P1|Participant Flow|Tenofovir DF|Tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg tablets plus a genotype-guided optimized background regimen (OBR; 3 minimum (min.)/5 maximum (max.) antiretroviral agents (ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks.
500565|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500566|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500567|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500568|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500569|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500570|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500571|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500572|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500573|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500575|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500576|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500577|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500578|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500579|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500580|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500581|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500582|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500583|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500584|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500585|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500586|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500587|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500588|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500589|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500590|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500591|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500592|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500593|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500594|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500595|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500761|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500596|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500597|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500598|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500599|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500600|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500601|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500602|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500603|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500604|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500605|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA >= 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500606|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500607|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500608|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500609|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500610|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500611|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500612|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500613|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500614|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500615|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500616|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500762|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500617|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500618|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500619|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500620|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500621|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500622|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500623|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500624|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500625|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500626|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500627|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500628|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500629|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500630|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500631|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500632|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500633|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500634|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500635|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500636|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500637|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500763|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
501098|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
500638|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500639|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500640|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500641|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500642|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500643|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500644|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500645|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500646|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500647|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500648|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500649|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500650|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500651|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500652|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500653|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500654|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500655|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500656|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500657|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500658|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500868|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500659|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500660|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500661|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500662|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500663|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500664|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500665|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500666|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500667|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500668|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500669|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500670|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500671|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500672|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500673|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500674|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500675|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500676|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500677|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500678|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500679|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500764|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500680|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500681|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500682|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500683|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500684|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500685|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500686|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500687|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500688|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500689|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500690|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500691|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500692|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500693|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500694|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500695|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500696|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500697|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500698|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500699|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500700|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500765|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500701|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500702|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500703|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500704|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500705|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500706|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500707|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500708|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500709|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500710|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500711|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500712|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500713|NCT00352053|O2|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500714|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization.
500715|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500716|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500717|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500718|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500719|NCT00352053|O4|Outcome|Placebo/TDF, HIV-1 RNA ≥ 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA ≥ 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500720|NCT00352053|O3|Outcome|Placebo/TDF, HIV-1 RNA < 1000 Copies/mL|Participants who were randomized to placebo and switched to open-label TDF 300 mg tablets (plus OBR) with HIV-1 RNA < 1000 copies/mL at the time of the switch when a new baseline was established. The analysis time point is calculated as the number of weeks after the switch.
500721|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500766|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500722|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500723|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500724|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500725|NCT00352053|O2|Outcome|Placebo|Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500726|NCT00352053|O1|Outcome|Tenofovir DF|TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks. The analysis time point is calculated as the number of weeks after randomization. Only data collected during the double-blind phase are included.
500727|NCT00352053|E3|Reported Event|All TDF|"Adverse events reported for the All TDF group include those reported during the double-blind phase and/or extension phase for subjects who were randomized to TDF group plus adverse events reported during the extension phase only for subjects who switched from placebo to open-label TDF.~Tenofovir DF 300-mg tablets in participants initially randomized to the Tenofovir DF group, and in those initially randomized to the Placebo group who later switched to open-label TDF 300 mg."
500728|NCT00352053|E2|Reported Event|Placebo|"Adverse events occurring in the double-blind phase are presented for this reporting group.~Placebo to match TDF plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
500729|NCT00352053|E1|Reported Event|Tenofovir DF|"Adverse events occurring in the double-blind phase are presented for this reporting group.~TDF 300 mg tablets plus a genotype-guided OBR (3 min./5 max. ARVs) from baseline to Week 48 (double-blind phase), followed by open-label TDF 300 mg plus OBR for up to an additional 288 weeks."
500730|NCT00352027|B1|Baseline|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500731|NCT00352027|P1|Participant Flow|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500732|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500733|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500734|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500735|NCT00352027|O8|Outcome|HOD99 - Grade 5|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
500736|NCT00352027|O7|Outcome|HOD99 - Grade 4|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
500737|NCT00352027|O6|Outcome|HOD99 - Grade 3|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
500738|NCT00352027|O5|Outcome|HOD99 - Grade 2|Intermediate Risk participants treated on earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital.
500739|NCT00352027|O4|Outcome|HOD05 - Grade 5|Participants in current study.
500740|NCT00352027|O3|Outcome|HOD05 - Grade 4|Participants in current study.
500741|NCT00352027|O2|Outcome|HOD05 - Grade 3|Participants in current study.
500742|NCT00352027|O1|Outcome|HOD05 - Grade 2|Participants in current study.
500767|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500743|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
500744|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500745|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA, OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
500746|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500747|NCT00352027|O2|Outcome|HOD99 Participants|"Intermediate Risk participants treated on the earlier HOD99 protocol (NCT00145600) at St. Jude Children's Research Hospital. Intermediate Risk was defined as participants with stage classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants received 2 alternating cycles of VAMP/COP chemotherapy (total of 4 cycles of chemotherapy) plus low-dose, involved-field radiotherapy. VAMP chemotherapy includes vinblastine, adriamycin, methotrexate and prednisone. COP chemotherapy includes Cyclophosphamide, Oncovin and Procarbazine."
500748|NCT00352027|O1|Outcome|HOD05 Participants|"Current study defined as Intermediate Risk single arm classified as:~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500749|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500750|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500751|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500752|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500753|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500754|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500755|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500756|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500757|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500758|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500759|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500760|NCT00352027|O1|Outcome|QoL Participants|All participants who completed the required questionnaires during at least one time point for evaluating this outcome.
500769|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500770|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500771|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500772|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500773|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500774|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500775|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500776|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500777|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500778|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500779|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500780|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500781|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500782|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500783|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500784|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500785|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500786|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500787|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500788|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500789|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500790|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500791|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500792|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500793|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500794|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500795|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500796|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500797|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500798|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500799|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500800|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500801|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500802|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500803|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500804|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500805|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500806|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500807|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500808|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500809|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500810|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500811|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500812|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500813|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500814|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500815|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500869|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500816|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500817|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500818|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500819|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500820|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500821|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500822|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500823|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500824|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500825|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500826|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500827|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500828|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500829|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500830|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500831|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500832|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500833|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500834|NCT00352027|O5|Outcome|Parent and Patient Scores at Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500835|NCT00352027|O4|Outcome|Parent and Patient Scores at After Radiation|Evaluation completed following radiation therapy.
500836|NCT00352027|O3|Outcome|Parent and Patient Scores at Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500837|NCT00352027|O2|Outcome|Parent and Patient Scores at Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500838|NCT00352027|O1|Outcome|Parent and Patient Scores at Pre-therapy|Evaluation completed prior to the start of treatment.
500839|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500840|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500841|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500842|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500843|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500844|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500845|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500846|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500847|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500848|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500849|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500850|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500851|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500852|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500853|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500854|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500855|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500856|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500857|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500858|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500859|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500860|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500861|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500862|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500863|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500864|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500865|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500866|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500867|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
501099|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
500871|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500872|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500873|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500874|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500875|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500876|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500877|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500878|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500879|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500880|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500881|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500882|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500883|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500884|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500885|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500886|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500887|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500888|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500889|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500890|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500891|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500892|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500893|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500894|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500895|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500896|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500897|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500898|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500899|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500900|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500901|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500902|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500903|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500904|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500905|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500906|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500907|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500908|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500909|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500910|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500911|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500912|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500913|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500914|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500915|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500916|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500917|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500918|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500919|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500920|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500921|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500922|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500923|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500924|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500925|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500926|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500927|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500929|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500930|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500931|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500932|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500933|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500934|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500935|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500936|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500937|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500938|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500939|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500940|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500941|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500942|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500943|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500944|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500945|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500946|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500947|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500948|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500949|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500950|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500951|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500952|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500953|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500954|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500955|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500956|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500957|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500958|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500959|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500960|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500961|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500962|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500963|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500964|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500965|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500966|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500967|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500968|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500969|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500970|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500971|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500972|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500973|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500974|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500975|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500976|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500977|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500978|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500979|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500980|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500981|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500982|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500983|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500984|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500985|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
501100|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
500986|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500987|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500988|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500989|NCT00352027|O5|Outcome|Off-therapy|Evaluation completed approximately 3-6 months following completion of therapy.
500990|NCT00352027|O4|Outcome|After Radiation|Evaluation completed following radiation therapy.
500991|NCT00352027|O3|Outcome|Week 12|Evaluation completed following 4 courses of therapy, approximately week 16 after start.
500992|NCT00352027|O2|Outcome|Week 8|Evaluation completed following 2 courses of therapy, approximately week 8 after start.
500993|NCT00352027|O1|Outcome|Pre-therapy|Evaluation completed prior to the start of treatment.
500994|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500995|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500996|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500997|NCT00352027|O1|Outcome|Stanford V Chemotherapy|"Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500998|NCT00352027|E1|Reported Event|Stanford V Chemotherapy|"Intermediate risk single arm study defined as~EITHER Ann Arbor stage IB and IIIA,~OR Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph).~Participants receive 12 weeks of Stanford V chemotherapy:~Adriamycin, IV, Day 1 of weeks 1, 3, 5, 7, 9 and 11 Vinblastine, IV, Day 1 of weeks 1, 3, 5, 7, 9, 11 Nitrogen Mustard (or Cyclophosphamide), IV, Day 1 of weeks 1, 5, 9 Vincristine, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Bleomycin, IV, Day 1 of weeks 2, 4, 6, 8, 10, 12 Etoposide, IV, Days 1, 2 of weeks 1-10 Prednisone, PO, every other day of weeks 1-12 G-CSF, SC, days 3-13, 16-26, 29-39, 42-52, 55-65, 68-78 (as clinically indicated)~After completion of 12 weeks of Stanford V chemotherapy, participants receive radiotherapy."
500999|NCT00353119|B3|Baseline|Total|Total of all reporting groups
501000|NCT00353119|B2|Baseline|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
501001|NCT00353119|B1|Baseline|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
501002|NCT00353119|P2|Participant Flow|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
501003|NCT00353119|P1|Participant Flow|Placebo Then Etanercept|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1 then crossed over to etanercept 50mg twice weekly for weeks 12 to 24
501004|NCT00353119|O1|Outcome|Etanercept After Placebo|Group 1 patients that crossed over to etanercept 50mg twice weekly for weeks 12 to 24 after having initiated the study with placebo for the first 12 weeks
501005|NCT00353119|O1|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
501006|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND Patients that crossed over to etanercept 50 mg subcutanously twice weekly after taking placebo for the first 12 weeks.
501007|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
501008|NCT00353119|O2|Outcome|Etanercept|Patients randomized to etanercept - Group 2. Patients received etanercept 50 mg subcutaneously twice weekly for 24 weeks
501009|NCT00353119|O1|Outcome|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks - Group 1
501010|NCT00353119|E2|Reported Event|Etanercept|Patients randomized to etanercept who received etanercept 50 mg subcutaneously twice weekly for 24 weeks AND patients who crossed over to etanercept 50 mg subcutaneously twice a week for 12 weeks.
501011|NCT00353119|E1|Reported Event|Placebo|Patients randomized to initiate the study with placebo for the first 12 weeks
501012|NCT00352911|B3|Baseline|Total|Total of all reporting groups
501013|NCT00352911|B2|Baseline|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501014|NCT00352911|B1|Baseline|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501101|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
501102|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
501015|NCT00352911|P2|Participant Flow|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501016|NCT00352911|P1|Participant Flow|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501017|NCT00352911|O2|Outcome|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501018|NCT00352911|O1|Outcome|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501019|NCT00352911|E2|Reported Event|Placebo for VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501020|NCT00352911|E1|Reported Event|VGX-410 (Mifepristone)|150mg twice daily for 14 days and if well tolerated, dose escalation to 300mg twice daily for 14 days
501021|NCT00352885|B3|Baseline|Total|Total of all reporting groups
501022|NCT00352885|B2|Baseline|Placebo|Participants will receive placebo and IL-2 treatment
501023|NCT00352885|B1|Baseline|Escitalopram|Participants will receive escitalopram and IL-2 treatment
501024|NCT00352885|P2|Participant Flow|Placebo|Participants will receive placebo 2 weeks before and during IL-2 treatment
501025|NCT00352885|P1|Participant Flow|Escitalopram|Participants will receive escitalopram 10-20 mg/day 2 weeks before and during IL-2 treatment
501026|NCT00352885|O2|Outcome|Placebo|Participants will receive placebo and IL-2 treatment
501027|NCT00352885|O1|Outcome|Escitalopram|Participants will receive escitalopram and IL-2 treatment
501028|NCT00352885|E2|Reported Event|Placebo|Participants will receive placebo and IL-2 treatment
501029|NCT00352885|E1|Reported Event|Escitalopram|Participants will receive escitalopram and IL-2 treatment
501030|NCT00352846|B3|Baseline|Total|Total of all reporting groups
501031|NCT00352846|B2|Baseline|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
501032|NCT00352846|B1|Baseline|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
501033|NCT00352846|P2|Participant Flow|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
501034|NCT00352846|P1|Participant Flow|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
501035|NCT00352846|O2|Outcome|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
501036|NCT00352846|O1|Outcome|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
501037|NCT00352846|E2|Reported Event|Vitamin D + Calcium Carbonate + Zoledronic Acid|Oral Vitamin D 400 mg daily and Calcium 1200 mg daily; Zoledronic Acid 4 mg/m^2 intravenous at baseline and 6 months.
501038|NCT00352846|E1|Reported Event|Vitamin D + Calcium Carbonate|Oral Vitamin D 400 mg daily + Calcium 1200 mg daily
501039|NCT00352781|B1|Baseline|Nicotine Replacement Therapy (NRT)|Open-label Nicotine Replacement Therapy + counseling
501040|NCT00352781|P1|Participant Flow|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy (as per product monograph) + counseling
501041|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
501042|NCT00352781|O1|Outcome|Nicotine Replacement Therapy|Open-label nicotine replacement therapy (as per product monograph) plus counseling
501043|NCT00352781|E1|Reported Event|Nicotine Replacement Therapy + Counseling|Up to 10 weeks of open-label nicotine replacement therapy + counseling
501044|NCT00352755|B1|Baseline|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501045|NCT00352755|P1|Participant Flow|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501046|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501047|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501048|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501049|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501050|NCT00352755|O1|Outcome|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m^2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m^2 over 2 hours with leucovorin at 400 mg/m^2 and IV 5-FU at 2400 mg/m^2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501051|NCT00352755|E1|Reported Event|Peritonectomy + IP5FU + FOLFOX|"Surgical debulking with peritonectomy~IP 5FU 600 mg/m2 over 30-60 minutes with patient rotating every 15 minutes. Repeated every 2 weeks for a total of 9 cycles.~FOLFOX (oxaliplatin, 5FU, leucovorin) will follow IP therapy. Oxaliplatin 85 mg/m2 over 2 hours with leucovorin at 400 mg/m2 and IV 5-FU at 2400 mg/m2 over 46 hours. Repeated every 2 weeks for a total of 8 cycles."
501052|NCT00352690|B3|Baseline|Total|Total of all reporting groups
501053|NCT00352690|B2|Baseline|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501054|NCT00352690|B1|Baseline|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501055|NCT00352690|P2|Participant Flow|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501056|NCT00352690|P1|Participant Flow|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501057|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501058|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501059|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501060|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501061|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501062|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501063|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501103|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
501104|NCT00352417|O2|Outcome|Matching Placebo|Placebo Dose
501105|NCT00352417|O1|Outcome|VIA-2291|100-mg dose
501106|NCT00352417|E2|Reported Event|Matching Placebo|Placebo Dose
501107|NCT00352417|E1|Reported Event|VIA-2291|100-mg dose
501064|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501065|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501066|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501067|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501068|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501069|NCT00352690|O2|Outcome|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501070|NCT00352690|O1|Outcome|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501071|NCT00352690|E2|Reported Event|Cohort 2 (Remaining Patients)|"Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501072|NCT00352690|E1|Reported Event|Cohort 1 (First 12 Eligible Patients)|"Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.~Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.~Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.~Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.~Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles."
501073|NCT00352664|B3|Baseline|Total|Total of all reporting groups
501074|NCT00352664|B2|Baseline|Placebo|Oral Placebo tablet daily x 7 days
501075|NCT00352664|B1|Baseline|Donepezil|Oral Donepezil 5 mg daily x 7 days
501076|NCT00352664|P2|Participant Flow|Placebo|Oral Placebo tablet daily x 7 days
501077|NCT00352664|P1|Participant Flow|Donepezil|Oral Donepezil 5 mg daily x 7 days
501078|NCT00352664|O2|Outcome|Placebo|Oral Placebo tablet daily x 7 days
501079|NCT00352664|O1|Outcome|Donepezil|Oral Donepezil 5 mg daily x 7 days
501080|NCT00352664|E2|Reported Event|Placebo|Oral Placebo tablet daily x 7 days
501081|NCT00352664|E1|Reported Event|Donepezil|Oral Donepezil 5 mg daily x 7 days
501082|NCT00352612|B3|Baseline|Total|Total of all reporting groups
501083|NCT00352612|B2|Baseline|Group 2|clindamycin arm
501084|NCT00352612|B1|Baseline|Group 1|cephalexin arm
501085|NCT00352612|P2|Participant Flow|Clindamycin|those who received clindamycin
501086|NCT00352612|P1|Participant Flow|Cephalexin|patients who received cephalexin
501087|NCT00352612|O2|Outcome|Clindamycin|those patients who received clindamycin
501088|NCT00352612|O1|Outcome|Cephalexin|those patients who received cephalexin
501089|NCT00352612|E2|Reported Event|Clindamycin|
501090|NCT00352612|E1|Reported Event|Cephalexin|
501091|NCT00352417|B3|Baseline|Total|Total of all reporting groups
501092|NCT00352417|B2|Baseline|Matching Placebo|Placebo Dose
501093|NCT00352417|B1|Baseline|VIA-2291|100-mg dose
501094|NCT00352417|P2|Participant Flow|Matching Placebo|Placebo Dose
501095|NCT00352417|P1|Participant Flow|VIA-2291|100-mg dose
501108|NCT00352365|B1|Baseline|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
501109|NCT00352365|P1|Participant Flow|Lenalidomide|Induction Therapy: Oral lenalidomide once daily on days 1-14, 1-21, or 1-28. Maintenance Therapy: Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
501110|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
501111|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
501112|NCT00352365|O2|Outcome|Nonresponders|Eligible and evaluable patients who did not achieve CR/CRi/PR
501113|NCT00352365|O1|Outcome|Responders|Eligible and evaluable patients who achieved CR/CRi/PR
501114|NCT00352365|O2|Outcome|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
501115|NCT00352365|O1|Outcome|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
501116|NCT00352365|E2|Reported Event|Maintenance Therapy|Oral lenalidomide once daily on days 1-21 (1 cycle = 28 days)
501117|NCT00352365|E1|Reported Event|Induction Therapy|Oral lenalidomide once daily on days 1-14, 1-21, or 1-28
501118|NCT00351936|B1|Baseline|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
501119|NCT00351936|P1|Participant Flow|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
501120|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501121|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501122|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501123|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501124|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501125|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501126|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501127|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501128|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501129|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501130|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501131|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501132|NCT00351936|O2|Outcome|Placebo|Olanzapine-treated subjects took adjunctive placebo tablets (to match aripiprazole 15mg/day tablets) for 4 weeks.
501133|NCT00351936|O1|Outcome|Aripiprazole|Olanzapine-treated subjects took adjunctive aripiprazole 15mg/day tablets for 4 weeks.
501134|NCT00351936|E1|Reported Event|Cross-over Aripiprazole and Placebo|This double-blind, placebo-controlled, crossover study consisted of 2 random-order 4-week treatment arms(aripiprazole 15 mg or placebo) separated by a 2-week adjuvant treatment washout. After baseline, subjects were randomized, double blind, to either aripiprazole or placebo for 4 weeks. After the initial 4 weeks of medication, subjects were reassessed, had a 2-week washout period, and then another complete assessment before receiving the other treatment of another 4 weeks. All assessments were again repeated at week 10.
501135|NCT00351741|B3|Baseline|Total|Total of all reporting groups
501136|NCT00351741|B2|Baseline|Conventional|Low-tidal volume ventilation
501137|NCT00351741|B1|Baseline|High Frequency|Intervention with high frequency percussive ventilation
501138|NCT00351741|P2|Participant Flow|Conventional|Low-tidal volume ventilation
501139|NCT00351741|P1|Participant Flow|High Frequency|Intervention with high frequency percussive ventilation
501140|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501141|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501142|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501143|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501144|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501145|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501146|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501147|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501148|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501149|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501150|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501151|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501152|NCT00351741|O2|Outcome|Conventional|Low-tidal volume ventilation
501153|NCT00351741|O1|Outcome|High Frequency|Intervention with high frequency percussive ventilation
501154|NCT00351741|E2|Reported Event|Conventional|Low-tidal volume ventilation
501155|NCT00351741|E1|Reported Event|High Frequency|Intervention with high frequency percussive ventilation
501157|NCT00351533|B2|Baseline|Enteral Saline|7.5cc 0.9% saline every 6 hours
501158|NCT00351533|B1|Baseline|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501159|NCT00351533|P2|Participant Flow|Enteral Saline|7.5cc 0.9% saline every 6 hours
501160|NCT00351533|P1|Participant Flow|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501161|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501162|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501163|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501164|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501165|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501166|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501167|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501168|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501169|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501170|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501171|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501172|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501173|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501174|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501175|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501176|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501177|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501178|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501179|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501180|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501181|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501182|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501183|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501184|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501185|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501186|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501187|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501188|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501189|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501190|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501191|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501192|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501193|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501194|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501195|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501196|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501197|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501198|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501199|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501200|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501201|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501202|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501203|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501204|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501205|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501206|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501207|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501208|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501209|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501210|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501211|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501212|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501213|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501214|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501215|NCT00351533|O2|Outcome|Enteral Saline|7.5cc 0.9% saline every 6 hours
501216|NCT00351533|O1|Outcome|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501217|NCT00351533|E2|Reported Event|Enteral Saline|7.5cc 0.9% saline every 6 hours
511395|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
501218|NCT00351533|E1|Reported Event|Enteral Fish Oil|7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily
501219|NCT00351377|B1|Baseline|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501220|NCT00351377|P1|Participant Flow|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501221|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501222|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501223|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501224|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501225|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501226|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501227|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501228|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501229|NCT00351377|O1|Outcome|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501230|NCT00351377|E1|Reported Event|Enteric-coated Mycophenolate Sodium|Enteric-coated Mycophenolate Sodium (EC-MPS) 180 mg and 360 mg tablets were administered orally in divided doses twice daily in a dose that was equimolar to the dose of Mycophenolate mofetil the participant was taking at the time of study entry. The planned duration of treatment 6 to 8 weeks.
501231|NCT00351351|B3|Baseline|Total|Total of all reporting groups
501232|NCT00351351|B2|Baseline|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
501233|NCT00351351|B1|Baseline|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
501234|NCT00351351|P2|Participant Flow|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
501235|NCT00351351|P1|Participant Flow|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
501236|NCT00351351|O2|Outcome|Currently Available Lithotripsy Techology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
501237|NCT00351351|O1|Outcome|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
501238|NCT00351351|E2|Reported Event|Currently Available Lithotripsy Technology|"Currently available lithotripsy technology~single probe ultrasonic : FDA-approved - single probe ultrasonic"
501239|NCT00351351|E1|Reported Event|Cyberwand|"Cyberwand~Cyberwand : FDA approved - dual probe intracorporeal lithotrite"
501240|NCT00351273|B4|Baseline|Total|Total of all reporting groups
501241|NCT00351273|B3|Baseline|Placebo|Participants will receive placebo
501242|NCT00351273|B2|Baseline|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
501243|NCT00351273|B1|Baseline|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
501244|NCT00351273|P3|Participant Flow|Placebo|Participants will receive placebo
501245|NCT00351273|P2|Participant Flow|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
501246|NCT00351273|P1|Participant Flow|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
501247|NCT00351273|O3|Outcome|Placebo|Participants will receive placebo
501248|NCT00351273|O2|Outcome|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
501249|NCT00351273|O1|Outcome|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
501250|NCT00351273|E3|Reported Event|Placebo|Participants will receive placebo
501251|NCT00351273|E2|Reported Event|Doxycycline & Rifampin|Participants will receive Doxycycline and Rifampin
501252|NCT00351273|E1|Reported Event|Azithromycin & Rifampin|Participants will receive Azithromycin and Rifampin
511396|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
501253|NCT00351039|B1|Baseline|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501254|NCT00351039|P1|Participant Flow|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501255|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
501256|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
501257|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501258|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501259|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501260|NCT00351039|O1|Outcome|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg PO QD for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 Q21 Pemetrexed 500 mg/m2 Day 1 Q 21 Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive) This dose was then recommended to be phase II dose."
501261|NCT00351039|E1|Reported Event|Experimental: Bevacizumab, Erlotinib, Pemetrexed|"Treatment Regimen Item 1: Bevacizumab 10mg/Kg I. V. Day 1 and Day 15. Repeat cycles every 28 days. Treatment Regimen Item 2: Erlotinib(Tarceva™) 150mg Per Orally (PO) Once Daily (QD) for 7 days starting day 2 and day 15. Repeat cycles every 28 days. Treatment Regimen Item 3: Pemetrexed(Alimta™) 500mg/m2 I.V. Day 1 and Day 15. Repeat cycles every 28 days. The regimen then was modified to the following dose:~Bevacizumab 15mg/kg Day 1 every 21 days (Q21); Pemetrexed 500 mg/m2 Day 1 Q 21; Erlotinib 150 mg QD PO Day 2 to day 15 (Both days inclusive). This dose was then recommended to be Phase II dose."
501262|NCT00351000|B1|Baseline|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
501263|NCT00351000|P1|Participant Flow|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
501264|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
501265|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dose will be unchanged during the trial.
501266|NCT00351000|O2|Outcome|Olanzapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's olanzapine dosage will be unchanged during the trial.
501267|NCT00351000|O1|Outcome|Clozapine Treatment With Adjunctive Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine dosage will be unchanged during the trial.
501268|NCT00351000|E1|Reported Event|Open-label Ziprasidone|All subjects will be treated with open label ziprasidone 40 mg 2x/day for the first 2 weeks. After 2 weeks the study drug may be increased up to ziprasidone 80 mg 2x/day. The subject's clozapine or olanzapine dose will be unchanged during the trial.
501269|NCT00350870|B5|Baseline|Total|Total of all reporting groups
501270|NCT00350870|B4|Baseline|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
501271|NCT00350870|B3|Baseline|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
501272|NCT00350870|B2|Baseline|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
501273|NCT00350870|B1|Baseline|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
501274|NCT00350870|P4|Participant Flow|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
501275|NCT00350870|P3|Participant Flow|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
501276|NCT00350870|P2|Participant Flow|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
501277|NCT00350870|P1|Participant Flow|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
501278|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
501279|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
501280|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
501281|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
501282|NCT00350870|O4|Outcome|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
501283|NCT00350870|O3|Outcome|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
501284|NCT00350870|O2|Outcome|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
501285|NCT00350870|O1|Outcome|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
501286|NCT00350870|E4|Reported Event|Disulfiram Plus Contingency Management|"Disulfiram plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Disulfiram plus Contingency Management: 250mg of Disulfiram plus Contingency Management for cocaine abstinence and medication compliance plus CBT."
501287|NCT00350870|E3|Reported Event|Placebo Plus Contingency Management|"Placebo plus Contingency Management for cocaine abstinence and medication compliance (in addition to CBT).~Placebo plus Contingency Management: Placebo plus Contingency Management for cocaine abstinence and medication compliance in addition to CBT"
501288|NCT00350870|E2|Reported Event|Disulfiram|"Disulfiram (plus CBT)~disulfiram: 250mg per day of Disulfiram plus CBT"
501289|NCT00350870|E1|Reported Event|Placebo|"Placebo (plus Cognitive Behavioral Therapy- CBT)~Placebo: Placebo plus CBT"
501290|NCT00350844|B1|Baseline|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
501291|NCT00350844|P1|Participant Flow|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
501292|NCT00350844|O1|Outcome|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
501293|NCT00350844|E1|Reported Event|Hydroxyurea|Hydroxyurea : 20 mg/kg/day and dose escalating every 2 months until maximum tolerated dose.
501294|NCT00350792|B1|Baseline|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501295|NCT00350792|P1|Participant Flow|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501296|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501297|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501298|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501299|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501300|NCT00350792|O1|Outcome|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501301|NCT00350792|E1|Reported Event|Pemetrexed + Carboplatin|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 6 cycles.~Carboplatin: Area Under the Curve (AUC) 5, intravenous (IV), every 21 days x 6 cycles."
501302|NCT00350779|B3|Baseline|Total|Total of all reporting groups
501303|NCT00350779|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501304|NCT00350779|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501305|NCT00350779|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501306|NCT00350779|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501307|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501308|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501309|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501310|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501311|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501312|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501313|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501314|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501315|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501316|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501317|NCT00350779|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501318|NCT00350779|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501319|NCT00350779|E4|Reported Event|Placebo Data Through Week 54|
501320|NCT00350779|E3|Reported Event|Sitagliptin 100 mg Data Through Week 54|
501321|NCT00350779|E2|Reported Event|Placebo Data Through Week 18|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501322|NCT00350779|E1|Reported Event|Sitagliptin 100 mg Data Through Week 18|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label rosiglitazone 4 mg oral tablets (4 to 8 mg/day) and open-label metformin 500 mg oral tablets (≥1500 mg/day).
501323|NCT00350727|B4|Baseline|Total|Total of all reporting groups
501324|NCT00350727|B3|Baseline|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501325|NCT00350727|B2|Baseline|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501326|NCT00350727|B1|Baseline|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501327|NCT00350727|P3|Participant Flow|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501328|NCT00350727|P2|Participant Flow|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501329|NCT00350727|P1|Participant Flow|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501330|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501331|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501332|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501333|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
501334|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501335|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501336|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501337|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501338|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501339|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501340|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501341|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed EGFRvIII and/or PTEN.
501342|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501343|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501344|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501345|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501346|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501347|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501348|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501349|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501350|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501351|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501352|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501353|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501354|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501355|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501356|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501357|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501358|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501359|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501360|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
511397|NCT00319553|O1|Outcome|Adacel® Vaccine Group|
501361|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501362|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501363|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501364|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501365|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501366|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501367|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501368|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501369|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501370|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501371|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501372|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501373|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501374|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501375|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501376|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501377|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501378|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501379|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501380|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501381|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501382|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501383|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501384|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501385|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501386|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501387|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501388|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501389|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501390|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501391|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501392|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501393|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501394|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501395|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501396|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501397|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501398|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501399|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501400|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501401|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501402|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501403|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501404|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501405|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501406|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501407|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501408|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501409|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501410|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501411|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501412|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501413|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501414|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501415|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501416|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501417|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501418|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501419|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501420|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501421|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501422|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501423|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501424|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501425|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg/Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501426|NCT00350727|O6|Outcome|Phase I: Pazopanib 600 mg/Lapatinib 1000 mg|Pazopanib 600 mg BID and Lapatinib 1000 mg BID
501427|NCT00350727|O5|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 1000 mg|Pazopanib 800 mg OD and Lapatinib 1000 mg BID
501428|NCT00350727|O4|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 750 mg|Pazopanib 800 mg OD and Lapatinib 750 mg BID
501429|NCT00350727|O3|Outcome|Phase I: Pazopanib 800 mg/Lapatinib 500 mg|Pazopanib 800 mg OD and Lapatinib 500 mg BID
501430|NCT00350727|O2|Outcome|Phase I: Pazopanib 800 mg /Lapatinib 1500 mg|Pazopanib 800 mg OD and Lapatinib 1500 mg OD
501431|NCT00350727|O1|Outcome|Phase I: Pazopanib 200 mg /Lapatinib 1500 mg|Pazopanib 200 mg OD and Lapatinib 1500 mg OD
501432|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501433|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501434|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501435|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501436|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501437|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501438|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501439|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501440|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501441|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501442|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501443|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501444|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501445|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501446|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501447|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501448|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501449|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501450|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501488|NCT00350636|E1|Reported Event|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501489|NCT00350623|B4|Baseline|Total|Total of all reporting groups
501451|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501452|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501453|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501454|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501455|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501456|NCT00350727|O2|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501457|NCT00350727|O1|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501458|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501459|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501460|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501461|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501462|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501463|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501464|NCT00350727|O3|Outcome|Phase II: Biomarker Negative|All participants received pazopanib 400 mg OD and lapatinib 1000 mg OD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501465|NCT00350727|O2|Outcome|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (BID) and lapatinib 1000 mg OD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501466|NCT00350727|O1|Outcome|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501467|NCT00350727|E3|Reported Event|Phase II: Biomarker Negative|All participants received pazopanib 400 mg QD and lapatinib 1000 mg QD. Biomarker-negative participants were those who did not express either EGFRvIII and/or PTEN.
501468|NCT00350727|E2|Reported Event|Phase II: Biomarker Positive|All participants received pazopanib 400 mg twice daily (QD) and lapatinib 1000 mg QD. Biomarker-positive participants were those who expressed epithelial growth factor receptor vIII (EGFRvIII) and/or phosphate and tensin homolog (PTEN).
501469|NCT00350727|E1|Reported Event|Phase I: Pazopanib 200-800 mg/Lapatinib 500-1500 mg|Starting dose of oral pazopanib of 200 milligrams (mg) once daily (OD) and oral lapatinib 1500 mg OD. The dose of pazopanib (200-800 mg) and lapatinib (500-1500 mg) in cohorts enrolled subsequent to the first dose cohort was determined by the toxicity profile of the combination therapy and the pharmacokinetic results from the prior cohort.
501470|NCT00350636|B3|Baseline|Total|Total of all reporting groups
501471|NCT00350636|B2|Baseline|Placebo Topical Gel|1 g placebo topical gel
501472|NCT00350636|B1|Baseline|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501473|NCT00350636|P2|Participant Flow|Placebo Topical Gel|1 g placebo topical gel
501474|NCT00350636|P1|Participant Flow|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501475|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501476|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501477|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501478|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501479|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501480|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501481|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501482|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501483|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501484|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501485|NCT00350636|O2|Outcome|Placebo Topical Gel|1 g placebo topical gel
501486|NCT00350636|O1|Outcome|Oxybutynin Topical Gel|1 g Oxybutynin topical gel
501487|NCT00350636|E2|Reported Event|Placebo Topical Gel|1 g placebo topical gel
501490|NCT00350623|B3|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501491|NCT00350623|B2|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501492|NCT00350623|B1|Baseline|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501493|NCT00350623|P3|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501494|NCT00350623|P2|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501495|NCT00350623|P1|Participant Flow|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501496|NCT00350623|O3|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501497|NCT00350623|O2|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501498|NCT00350623|O1|Outcome|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501499|NCT00350623|E3|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 1.5 x 10^10 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 1.5 x 10^10 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501500|NCT00350623|E2|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 8 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 8 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501501|NCT00350623|E1|Reported Event|MRKAd5 HIV-1 Gag/Pol/Nef 4 x 10^9 Ad5 vg/Dose|MRKAd5 HIV-1 gag/pol/nef 4 x 10^9 Ad5 vg/dose, 3 doses administered at Day 1, Week 4, and Week 26.
501502|NCT00350532|B3|Baseline|Total|Total of all reporting groups
501503|NCT00350532|B2|Baseline|Healthy Subjects|Healthy subjects with no existing pain conditions. Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
501504|NCT00350532|B1|Baseline|Neuropathic Pain Subjects|Subjects with existing neuropathic pain Outcome criterion is acetylcholine concentration in cerebrospinal fluid (CSF) at 60 minutes after injection.
501505|NCT00350532|P2|Participant Flow|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501506|NCT00350532|P1|Participant Flow|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501507|NCT00350532|O2|Outcome|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501508|NCT00350532|O1|Outcome|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501509|NCT00350532|E2|Reported Event|Healthy Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501510|NCT00350532|E1|Reported Event|Neuropathic Pain Subjects|Participants will be trained to accurately estimate pain by way of thermal heat testing. Next a small amount of spinal fluid will be withdrawn from each participant to measure the amounts of naturally-made chemicals in the participants' cerebrospinal fluid. Participants then will receive an injection of clonidine. After the injection, additional samples of spinal fluid will be taken to measure chemical changes in the fluid.
501511|NCT00350519|B3|Baseline|Total|Total of all reporting groups
501512|NCT00350519|B2|Baseline|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501513|NCT00350519|B1|Baseline|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501514|NCT00350519|P2|Participant Flow|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501515|NCT00350519|P1|Participant Flow|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501516|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501517|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501518|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501519|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501520|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501521|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501522|NCT00350519|O2|Outcome|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501523|NCT00350519|O1|Outcome|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501524|NCT00350519|E2|Reported Event|STANDARD THERAPY|Participants received standard of care based on the Institution’s treatment policy
501525|NCT00350519|E1|Reported Event|PROCRIT (Epoetin Alfa)|Participants received epoetin alfa 300 IU/kg subcutaneously once daily for 10 days, prior to surgery, on the day of surgery, and for four days after surgery
501526|NCT00350402|B3|Baseline|Total|Total of all reporting groups
501527|NCT00350402|B2|Baseline|Sham MST|Low intensity muscle strength training (5% MIP)
501528|NCT00350402|B1|Baseline|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
501529|NCT00350402|P2|Participant Flow|Sham MST|Low intensity muscle strength training (5% MIP)
501530|NCT00350402|P1|Participant Flow|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
501531|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"This intervention is identical in all ways to real treatment, except that training device requires less inspiratory effort. The training device is set at 5% MIP. )"
501532|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|Same as previously described. This intervention involves high intensity respiratory muscle strength training over 4 week period, 5 days a week, with training device set at 75% maximal inspiratory pressure (MIP). The MIP is determined weekly and the training device recalibrated to take into account changes.
501533|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|Low intensity muscle strength training (5% MIP)
501534|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|high intensity respiratory muscle strength training, 75% MIP
501535|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"Same as previously described. The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
501536|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"Same as previously described. High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
501537|NCT00350402|O2|Outcome|Sham IMST: 5% MIP|"The Sham IMST intervention was identical to the real intervention in all ways except that the MIP is set for 5% MIP. Thus, less muscle effort was required during the exercise training."
501538|NCT00350402|O1|Outcome|Inspiratory Muscle Strength Training (IMST): 75% MIP|"High intensity respiratory muscle strength training took place over 4 weeks, 5 days a week. Each exercise session involved sets of breathing exercises taking approximately 20 minutes/day. The inspiratory exercises involved a breathing device that required individuals to take deep breaths and breathe in (i.e., inspire). Settings on breathing device were determined by obtaining the individual's maximal inspiratory pressure (MIP) using a specialized breathing gauge. The MIP was determined each week, and the exercise breathing trainer was adjusted and set at 75% of the participant's MIP. Exercises took place in the home setting, with weekly visit by staff."
501539|NCT00350402|E2|Reported Event|Sham MST|Low intensity muscle strength training (5% MIP)
501540|NCT00350402|E1|Reported Event|Inspiratory Muscle Strength Training (IMST)|high intensity respiratory muscle strength training, 75% MIP
501541|NCT00350363|B1|Baseline|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
501542|NCT00350363|P1|Participant Flow|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
501543|NCT00350363|O1|Outcome|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
501544|NCT00350363|E1|Reported Event|1 Day of Gatifloxacin|eyes receiving gatifloxacin 4 times per day 1 day before surgery
501545|NCT00350272|B3|Baseline|Total|Total of all reporting groups
501546|NCT00350272|B2|Baseline|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501547|NCT00350272|B1|Baseline|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501548|NCT00350272|P2|Participant Flow|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501549|NCT00350272|P1|Participant Flow|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501550|NCT00350272|O2|Outcome|Lamivudine,Efavirenz,Tenofovir|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501551|NCT00350272|O1|Outcome|Elvucitabine, Efavirenz,Tenofovir|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501661|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501552|NCT00350272|O2|Outcome|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501553|NCT00350272|O1|Outcome|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501554|NCT00350272|E2|Reported Event|Elvucitabine|Elvucitabine (blinded) 10 mg/day in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501555|NCT00350272|E1|Reported Event|Lamivudine|Lamivudine (blinded) 300 mg daily in combination with open-label efavirenz 600 mg daily and open-label tenofovir 300 mg daily, all administered orally, over 12 weeks. Eligible subjects continued with an additional 84 weeks of open-label treatment (through Week 96).
501556|NCT00348374|B3|Baseline|Total|Total of all reporting groups
501557|NCT00348374|B2|Baseline|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501558|NCT00348374|B1|Baseline|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501559|NCT00348374|P2|Participant Flow|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501560|NCT00348374|P1|Participant Flow|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501561|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501562|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501563|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501564|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501565|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501566|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501567|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501568|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501569|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501662|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501570|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501571|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501572|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501573|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501574|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501575|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501576|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501577|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose, and individually adjusted doses, per subject's blood glucose, over the six months study, in addition to insulin glargine and oral agents.
501578|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501579|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501580|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501581|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501582|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501583|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501584|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501585|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501586|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501587|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501588|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501589|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501590|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501591|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501592|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501593|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501594|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501595|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501596|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501597|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501598|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501599|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501600|NCT00348374|O2|Outcome|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501601|NCT00348374|O1|Outcome|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501602|NCT00348374|E2|Reported Event|Insulin Lispro|Weight based initiation dose of insulin-lispro (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); divided into 3 equal preprandial doses [before breakfast, lunch, and dinner], and individually titrated doses per subject's blood glucose, in addition to insulin glargine and oral agents. The approximate insulin-lispro dose in units was prescribed based on the calculated dose of Exubera® (conversion from milligrams (mg) of Exubera® to international units (IU) of insulin-lispro was approx. 3:1).
501663|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501664|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501603|NCT00348374|E1|Reported Event|Exubera®|Weight based initiation dose of Exubera® (total daily dose: body weight in kilograms (kg) x 0.15 milligrams per kilogram (mg/kg); approx. 0.05 mg/kg per meal, three times per day [TID]), and individually titrated doses per subject's blood glucose in addition to insulin glargine and oral agents.
501604|NCT00348348|B3|Baseline|Total|Total of all reporting groups
501605|NCT00348348|B2|Baseline|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501606|NCT00348348|B1|Baseline|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501607|NCT00348348|P2|Participant Flow|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501608|NCT00348348|P1|Participant Flow|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501609|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501610|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501611|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501612|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501613|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501614|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501615|NCT00348348|O2|Outcome|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501616|NCT00348348|O1|Outcome|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501617|NCT00348348|E2|Reported Event|Besifloxacin Suspension|Besifloxacin ophthalmic suspension 0.6%
501618|NCT00348348|E1|Reported Event|Moxifloxacin Solution|Moxifloxacin hydrochloride ophthalmic solution 0.5%
501619|NCT00348283|B3|Baseline|Total|Total of all reporting groups
501620|NCT00348283|B2|Baseline|Adalimumab 40 mg Every Other Week|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
501621|NCT00348283|B1|Baseline|Placebo|At Baseline (Week 0), subjects received an OL dose of 160 mg adalimumab SC followed by an OL dose of 80 mg adalimumab SC at Week 2 (induction dose). At Week 4, subjects were randomized to either adalimumab 40 mg SC eow or placebo SC eow.
501622|NCT00348283|P2|Participant Flow|Adalimumab|40 mg SC eow
501623|NCT00348283|P1|Participant Flow|Placebo|SC dosing eow
501624|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501625|NCT00348283|O1|Outcome|Placebo|
501626|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501627|NCT00348283|O1|Outcome|Placebo|
501628|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501629|NCT00348283|O1|Outcome|Placebo|
501630|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501631|NCT00348283|O1|Outcome|Placebo|
501632|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501633|NCT00348283|O1|Outcome|Placebo|
501634|NCT00348283|O2|Outcome|Adalimumab|40 mg every other week
501635|NCT00348283|O1|Outcome|Placebo|
501636|NCT00348283|E2|Reported Event|Adalimumab|All subjects (135 subjects) enrolled in the study received adalimumab 160 mg at Baseline followed by adalimumab 80 mg at Week 2 (Induction dose).
501637|NCT00348283|E1|Reported Event|Placebo|
501638|NCT00350220|B3|Baseline|Total|Total of all reporting groups
501639|NCT00350220|B2|Baseline|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
501640|NCT00350220|B1|Baseline|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
501641|NCT00350220|P2|Participant Flow|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
501642|NCT00350220|P1|Participant Flow|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
501643|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
501644|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
501645|NCT00350220|O2|Outcome|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
501646|NCT00350220|O1|Outcome|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
501647|NCT00350220|E2|Reported Event|Low Hb (Restrictive) Group|Low Hb transfusion group; RBCs are not transfused unless the Hb <9.0 g/dl and clinical indications for transfusion are met.
501648|NCT00350220|E1|Reported Event|High Hemoglobin (Liberal) Group|High Hemoglobin group; goal Hb >13g/dl. RBCs transfused for any Hemoglobin under 13g/dl regardless clinical indications for transfusion.
501649|NCT00350207|B4|Baseline|Total|Total of all reporting groups
501650|NCT00350207|B3|Baseline|Placebo|Matching Placebo
501651|NCT00350207|B2|Baseline|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501652|NCT00350207|B1|Baseline|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501653|NCT00350207|P3|Participant Flow|Placebo|Matching Placebo
501654|NCT00350207|P2|Participant Flow|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501655|NCT00350207|P1|Participant Flow|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501656|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501657|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501658|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501659|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501660|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501666|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501667|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501668|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501669|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501670|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501671|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501672|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501673|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501674|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501675|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501676|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501677|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501678|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501679|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501680|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501681|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501682|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501683|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501684|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501685|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501686|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501687|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501688|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501689|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501690|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501691|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501692|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501693|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501694|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501695|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501696|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501697|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501698|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501699|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501700|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501701|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501702|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501703|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501704|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501705|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501706|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501707|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501708|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501709|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501710|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501711|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501712|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501713|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501714|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501715|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501716|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501717|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501718|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501719|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501720|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501721|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501722|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501723|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501724|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501725|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501726|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501727|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501728|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501729|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501730|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501731|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501732|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501733|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501734|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501735|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501736|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501737|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501738|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501739|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501740|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501741|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501742|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501743|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501744|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501745|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501746|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501747|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501748|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501749|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501750|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501751|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501752|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501753|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501754|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501755|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501756|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501757|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501758|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501759|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501760|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501761|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501762|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501763|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501764|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501765|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501766|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501767|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501768|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501769|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501770|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501771|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501772|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501773|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501774|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501775|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501776|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501777|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501778|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501779|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501780|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501781|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501782|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501783|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501784|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501785|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501786|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501787|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501788|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501789|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501790|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501791|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501792|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501793|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501794|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501795|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501796|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501797|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501798|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501799|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501800|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501801|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501802|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501803|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501804|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501805|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501806|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501807|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501808|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501809|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501810|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501811|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501812|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501813|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501814|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501815|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501816|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501817|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501818|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501819|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501820|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501821|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501822|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501823|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501824|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501825|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501826|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501827|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501828|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501829|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501830|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501831|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501832|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501833|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501834|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501835|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501836|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501837|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501838|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501839|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501840|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501841|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501842|NCT00350207|O3|Outcome|Placebo|Matching Placebo
501843|NCT00350207|O2|Outcome|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501844|NCT00350207|O1|Outcome|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501845|NCT00350207|E3|Reported Event|Placebo|Matching Placebo
501846|NCT00350207|E2|Reported Event|Salmeterol|Salmeterol Metered Aerosol, 50mcg twice daily
501847|NCT00350207|E1|Reported Event|Tiotropium|Tiotropium inhalation solution, 5mcg once daily PM
501848|NCT00350142|B1|Baseline|SBRT|25 Gy single fraction dose using Trilogy linear accelerator
501849|NCT00350142|P1|Participant Flow|Stereotactic Body Radiotherapy|"patients that received a single fraction of 25 Gy Stereotactic Body Radiotherapy followed by weekly Gemcitabine administered at 1000mg/m2 over 100 minutes.~Patients will be followed at 4-6 weeks, 3 months, 6 months, 9 months and 1 year, in year 2 follow up will be every 4 months and in year 3 follow up will be every 6 months."
501850|NCT00350142|O1|Outcome|Stereotactic Body Radiotherapy|"single fraction 25 Gy dose Stereotactic Body Radiotherapy on Trilogy Linear Accelerator, followed by weekly Gemcitabine~Stereotactic Body Radiotherapy: Stereotactic Body Radiotherapy will be performed using Trilogy Linear Accelerator~Gemcitabine: Weekly Gemcitabine will be administered at 1000mg/m2 over 100 minutes"
501851|NCT00350142|O1|Outcome|Stereotactic Radiosurgery|patients w/ pancreas Cancer receiving Stereotactic Radiosurgery and Gemcitabine
501852|NCT00350142|E1|Reported Event|SBRT With Gem|patient with locally advanced pancreas cancer receiving Gem + SBRT
501853|NCT00349921|B5|Baseline|Total|Total of all reporting groups
501854|NCT00349921|B4|Baseline|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
501855|NCT00349921|B3|Baseline|Clonidine Given First, Then Placebo|clonidine given first placebo given in second injection
501856|NCT00349921|B2|Baseline|Adenosine Given First, Then Clonidine|adenosine given in first injection clonidine given in second injection
501857|NCT00349921|B1|Baseline|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
501858|NCT00349921|P4|Participant Flow|Adenosine First, Then Placebo|Adenosine given during the first period and placebo given during the second
501859|NCT00349921|P3|Participant Flow|Clonidine First, Then Placebo|Clonidine given as during the first period, then placebo during the second
501860|NCT00349921|P2|Participant Flow|Adenosine First, Then Clonidine|Adenosine given during the first period and adenosine given during the second
501861|NCT00349921|P1|Participant Flow|Clonidine First, Then Adenosine|Clonidine given during the first period and adenosine given during the second period
501862|NCT00349921|O3|Outcome|Placebo|Placebo received as either first or second injection
501863|NCT00349921|O2|Outcome|Adenosine|Adenosine received as either first or second injection
501864|NCT00349921|O1|Outcome|Clonidine|clonidine received as either first or second injection
501865|NCT00349921|E4|Reported Event|Adenosine First, Then Placebo|adenosine given in first injection placebo given in second injection
501866|NCT00349921|E3|Reported Event|Clonidine First, Then Placebo|clonidine given first placebo given in second injection
501867|NCT00349921|E2|Reported Event|Adenosine First, Then Clonidine|adenosine given in first injection clonidine given in second injection
501868|NCT00349921|E1|Reported Event|Clonidine First, Then Adenosine|clonidine given in first injection adenosine given in second injection
501869|NCT00349908|B3|Baseline|Total|Total of all reporting groups
501870|NCT00349908|B2|Baseline|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
501871|NCT00349908|B1|Baseline|Aneurysm Arm|Intracranial wide-necked aneurysms
501872|NCT00349908|P2|Participant Flow|Atherosclerosis Arm|Symptomatic stenosis in intracranial arteries
501873|NCT00349908|P1|Participant Flow|Aneurysm Arm|Intracranial wide-necked aneurysms
501874|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
501875|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
501876|NCT00349908|O2|Outcome|Group 2|Aneurysm Arm
501877|NCT00349908|O1|Outcome|Group 1|Atherosclerosis
501888|NCT00349908|E2|Reported Event|Group 2: Aneurysm Arm|This is the events from the Aneurysm Arm
501889|NCT00349908|E1|Reported Event|Group 1: Atherosclerosis Arm|This is the events from the Atherosclerosis Arm
501890|NCT00349752|B3|Baseline|Total|Total of all reporting groups
501891|NCT00349752|B2|Baseline|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501892|NCT00349752|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501893|NCT00349752|P2|Participant Flow|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501894|NCT00349752|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501895|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501896|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501897|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501898|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501899|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501900|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501901|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501902|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501903|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501904|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501905|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501906|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501907|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501908|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501909|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501910|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501911|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501912|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501913|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501914|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501915|NCT00349752|O2|Outcome|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501916|NCT00349752|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501917|NCT00349752|E2|Reported Event|Placebo|Placebo provided for subcutaneous injection in 2 single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501918|NCT00349752|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg provided in a solution for subcutaneous injection (2 x 200 mg/mL) in single-use vials for administration at Weeks 0, 2, 4 and then every 4 weeks until Week 36
501919|NCT00349622|B3|Baseline|Total|Total of all reporting groups
501920|NCT00349622|B2|Baseline|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501921|NCT00349622|B1|Baseline|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501922|NCT00349622|P2|Participant Flow|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501923|NCT00349622|P1|Participant Flow|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501924|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501925|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501926|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501927|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501928|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501929|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501930|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501931|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501932|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501933|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501934|NCT00349622|O2|Outcome|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501935|NCT00349622|O1|Outcome|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501936|NCT00349622|E2|Reported Event|Placebo|"One third of participants were assigned to placebo, or an inactive substance. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Pediatric multivitamin solution was used as the placebo in this study and was administered intravenously via a central venous catheter twice a day."
501937|NCT00349622|E1|Reported Event|Ceftriaxone|"Two thirds of participants were assigned to 4 grams of ceftriaxone per day. This is a blinded study, so neither participants nor study staff will know which treatment a participant is receiving.~Ceftriaxone is a cephalosporin antibiotic and was administered intravenously via a central venous catheter twice a day."
501938|NCT00349466|B3|Baseline|Total|Total of all reporting groups
501939|NCT00349466|B2|Baseline|Placebo|Placebo tablets q12 hours for 12 weeks
501940|NCT00349466|B1|Baseline|CF101 1 mg|CF101 1 mg q12 hours
501941|NCT00349466|P2|Participant Flow|Placebo|Placebo tablets q12 hours for 12 weeks
501942|NCT00349466|P1|Participant Flow|CF101 1 mg|CF101 1 mg q12 hours
501943|NCT00349466|O2|Outcome|Placebo BID|Oral tablets given every 12 hours for 12 weeks
501944|NCT00349466|O1|Outcome|CF101 1 mg BID|Oral tablets given every 12 hours for 12 weeks
501945|NCT00349466|E2|Reported Event|Placebo|Placebo tablets q12 hours for 12 weeks
501946|NCT00349466|E1|Reported Event|CF101 1 mg|CF101 1 mg q12 hours
501947|NCT00349388|B3|Baseline|Total|Total of all reporting groups
501948|NCT00349388|B2|Baseline|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
501949|NCT00349388|B1|Baseline|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
501950|NCT00349388|P2|Participant Flow|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
511398|NCT00319553|E2|Reported Event|Boostrix® Vaccine Group|
501951|NCT00349388|P1|Participant Flow|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
501952|NCT00349388|O2|Outcome|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
501953|NCT00349388|O1|Outcome|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
501954|NCT00349388|E2|Reported Event|Asacol BID/TID Dosing|"Asacol total dose split BID or TID~Asacol: Asacol is given once a day versus twice or three times a day"
501955|NCT00349388|E1|Reported Event|Asacol Once a Day Dosing|"Asacol total dose in mg/kg given once a day~Asacol: Asacol is given once a day versus twice or three times a day"
501956|NCT00349349|B4|Baseline|Total|Total of all reporting groups
501957|NCT00349349|B3|Baseline|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501958|NCT00349349|B2|Baseline|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501959|NCT00349349|B1|Baseline|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501960|NCT00349349|P3|Participant Flow|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other, defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501961|NCT00349349|P2|Participant Flow|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as bulky fludarabine refractory (BFR), defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501962|NCT00349349|P1|Participant Flow|2000 mg Ofatumumab + DR|Ofatumumab intravenous (iv) infusion was initiated at 300 milligrams (mg), followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The independent endpoint review committee (IRC) classified these participants as double refractory (DR), defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501963|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
501964|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
501965|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
501966|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined
501967|NCT00349349|O1|Outcome|2000 mg Ofatumumab + Total|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. Data from all three groups of participants (DR, BFR, and Other) have been combined.
501968|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501969|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501970|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501971|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501972|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501973|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501974|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501975|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501976|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501977|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501978|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501979|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501980|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501981|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501982|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501983|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501984|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501985|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501986|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501987|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501988|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501989|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501990|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501991|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501992|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501993|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501994|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501995|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501996|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
501997|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
501998|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
501999|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502000|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502001|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502002|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502003|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502004|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502005|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502006|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502007|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502008|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502009|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502010|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502011|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502012|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502013|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502014|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502015|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502016|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502017|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502018|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502019|NCT00349349|O3|Outcome|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502020|NCT00349349|O2|Outcome|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502021|NCT00349349|O1|Outcome|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502022|NCT00349349|E3|Reported Event|2000 mg Ofatumumab + Other|"Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as other,defined as participants who were enrolled in the study but did not meet criteria for DR or BFR."
502023|NCT00349349|E2|Reported Event|2000 mg Ofatumumab + BFR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as BFR, defined as participants who were enrolled in the study and were refractory to fludarabine with bulky lymphadenopathy.
502024|NCT00349349|E1|Reported Event|2000 mg Ofatumumab + DR|Ofatumumab iv infusion was initiated at 300 mg, followed by seven weekly 2000 mg infusions and then four monthly infusions of 2000 mg for a duration of 24 weeks. The IRC classified these participants as DR, defined as participants who were enrolled in the study and were refractory to both fludarabine and alemtuzumab.
502025|NCT00349336|B3|Baseline|Total|Total of all reporting groups
502026|NCT00349336|B2|Baseline|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502027|NCT00349336|B1|Baseline|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502028|NCT00349336|P2|Participant Flow|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502029|NCT00349336|P1|Participant Flow|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502030|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502031|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502032|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502033|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502034|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502120|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502035|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502036|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502037|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502038|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502039|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502040|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502041|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502042|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502043|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502044|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502045|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502046|NCT00349336|O2|Outcome|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502047|NCT00349336|O1|Outcome|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502048|NCT00349336|E2|Reported Event|FOLFOX-4+Bevacizumab|FOLFOX-4 regimen = oxaliplatin in combination with infusional 5-fluorouracil and leucovorin. Bevacizumab 5.0 mg/kg IV followed by oxaliplatin 85 mg/m² IV on Day 1 concomitantly with leucovorin 200 mg/m² IV, followed by 5-fluorouracil administered as a 400 mg/m² bolus injection, and then as a 600 mg/m² continuous infusion on Days 1 and 2; 2-week cycles for up to 48 weeks (Cycle 24).
502049|NCT00349336|E1|Reported Event|XELOX+Bevacizumab|XELOX regimen = oxaliplatin in combination with capecitabine. Bevacizumab 7.5 mg/kg IV followed by oxaliplatin 130 mg/m² IV on Day 1 in combination with capecitabine, administered orally at a dose of 1000 mg/m² twice daily (BID); 3-week cycles up to 48 weeks (Cycle 16).
502050|NCT00348933|B1|Baseline|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
502051|NCT00348933|P1|Participant Flow|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
502052|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
502053|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betain/B12)|All participants received treatment. Compared to a placebo group from a previous study.
502054|NCT00348933|O1|Outcome|Treatment (Metafolin/Creatine/Betaine/B12)|
502055|NCT00348933|E1|Reported Event|Metafolin, Betaine, Creatine, B12 Treatment|Participants will receive two daily doses of Metafolin, betaine, and creatine, and one daily dose of vitamin B12 for 12 months.
502056|NCT00348881|B3|Baseline|Total|Total of all reporting groups
502057|NCT00348881|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
502058|NCT00348881|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
502059|NCT00348881|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
502060|NCT00348881|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
502061|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
502062|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
502063|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
502064|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
502065|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/Hib™ Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
502066|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP-T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T Concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
502067|NCT00348881|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with OPV vaccines at 6, 10 and 14 weeks of age.
502068|NCT00348881|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with OPV vaccine, 1 dose each at 6, 10, and 14 weeks of age.
502069|NCT00348881|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with oral poliomyelitis vaccine (OPV) at 6, 10 and 14 weeks of age.
502070|NCT00348881|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP-T concomitantly with oral poliomyelitis vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
502071|NCT00348790|B1|Baseline|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
502072|NCT00348790|P1|Participant Flow|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
502073|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
502074|NCT00348790|O1|Outcome|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months."
502075|NCT00348790|E1|Reported Event|Vatalanib|"Patients will be treated with 500 mg of vatalanib, administered orally, twice a day for 28 days (1 cycle). Patients will start at a dose of 250 mg twice a day and increase by 250 mg per day every 7 days until 500 mg twice a day is reached.~Patients who are responding may remain on study treatment for 12 months.~vatalanib"
502076|NCT00348686|B1|Baseline|Candesartan|
502077|NCT00348686|P1|Participant Flow|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502078|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502079|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502080|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502081|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502082|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502083|NCT00348686|O1|Outcome|Candesartan|Subjects were treated for 24 weeks with Candesartan 16mg once daily as initial dose. Subjects were modified investigational product dose to Candesartan 32mg, Candesartan 32mg + Felodipine 5mg, Candesartan 32mg + Felodipine 10mg, sequentially according to their blood pressures.
502084|NCT00348686|E1|Reported Event|Candesartan|
502085|NCT00348673|B9|Baseline|Total|Total of all reporting groups
502086|NCT00348673|B8|Baseline|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502087|NCT00348673|B7|Baseline|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502250|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502088|NCT00348673|B6|Baseline|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502089|NCT00348673|B5|Baseline|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502090|NCT00348673|B4|Baseline|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502091|NCT00348673|B3|Baseline|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502092|NCT00348673|B2|Baseline|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502093|NCT00348673|B1|Baseline|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502094|NCT00348673|P9|Participant Flow|Placebo Once/Twice Daily (Stage 2)|Three placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502095|NCT00348673|P8|Participant Flow|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502096|NCT00348673|P7|Participant Flow|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502097|NCT00348673|P6|Participant Flow|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502098|NCT00348673|P5|Participant Flow|Placebo Once/Twice Daily (Stage 1)|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502099|NCT00348673|P4|Participant Flow|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502100|NCT00348673|P3|Participant Flow|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502101|NCT00348673|P2|Participant Flow|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502102|NCT00348673|P1|Participant Flow|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502103|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502104|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502105|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502106|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502107|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502108|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502109|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502110|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502111|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502112|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502113|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502114|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502115|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502116|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502117|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502118|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502119|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502251|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502121|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502122|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502123|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502124|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502125|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502126|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502127|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502128|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502129|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502130|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502131|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502132|NCT00348673|O8|Outcome|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502133|NCT00348673|O7|Outcome|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502134|NCT00348673|O6|Outcome|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502135|NCT00348673|O5|Outcome|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502136|NCT00348673|O4|Outcome|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502137|NCT00348673|O3|Outcome|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502138|NCT00348673|O2|Outcome|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502139|NCT00348673|O1|Outcome|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502140|NCT00348673|E8|Reported Event|Placebo|Placebo matched to UK-453,061 suspension orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 1 or 3 placebo tablets matched to UK-453,061 250 mg tablet along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once or twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502141|NCT00348673|E7|Reported Event|UK-453,061 100 mg Once Daily (Stage 2)|Two UK-453,061 50 mg tablets, equivalent to 100 mg UK-453,061, along with 3 placebo tablets matched to UK-453,061 250 mg tablet orally once daily for 8 days in Stage 2.
502142|NCT00348673|E6|Reported Event|UK-453,061 500 mg Twice Daily (Stage 2)|Two UK-453,061 250 mg tablets, equivalent to 500 mg UK-453,061, along with 1 placebo tablet matched to UK-453,061 250 mg tablet and 2 placebo tablets matched to UK-453,061 50 mg tablet orally twice daily for 7 days and as single morning dose on Day 8 in Stage 2.
502143|NCT00348673|E5|Reported Event|UK-453,061 750 mg Once Daily (Stage 2)|Three UK-453,061 250 mg tablets, equivalent to 750 mg UK-453,061, along with 2 placebo tablets matched to UK-453,061 50 mg tablet orally once daily for 8 days in Stage 2.
502144|NCT00348673|E4|Reported Event|UK-453,061 500 mg Once Daily (Stage 1)|UK-453,061 500 mg suspension orally once daily for 8 days in Stage 1.
502145|NCT00348673|E3|Reported Event|UK-453,061 100 mg Twice Daily (Stage 1)|UK-453,061 100 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502146|NCT00348673|E2|Reported Event|UK-453,061 30 mg Twice Daily (Stage 1)|UK-453,061 30 mg suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502147|NCT00348673|E1|Reported Event|UK-453,061 10 mg Twice Daily (Stage 1)|UK-453,061 10 milligram (mg) suspension orally twice daily for 7 days and as single morning dose on Day 8 in Stage 1.
502148|NCT00348556|B1|Baseline|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
502149|NCT00348556|P1|Participant Flow|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
502150|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
502151|NCT00348556|O1|Outcome|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
502152|NCT00348556|E1|Reported Event|Nesiritide|Subjects received an intrarenal infusion of nesiritide at 0.005 microgram/kg/min for 6 hours, 0.01 microgram/kg/min for 6 hours, 0.02 microgram/kg/min for 6 hours, and 0.03 microgram/kg/min for 6 hours.
502153|NCT00347958|B1|Baseline|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502154|NCT00347958|P1|Participant Flow|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502155|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502156|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502157|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502158|NCT00347958|O1|Outcome|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502159|NCT00347958|E1|Reported Event|Adacel® Vaccine Group|Participants 15 to 69 years of age who received a dose of Adacel vaccine in one of three previous studies (Td501, or Td502, or Td505), revaccinated in Study Td518.
502160|NCT00347932|B3|Baseline|Total|Total of all reporting groups
502161|NCT00347932|B2|Baseline|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502162|NCT00347932|B1|Baseline|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502163|NCT00347932|P2|Participant Flow|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502164|NCT00347932|P1|Participant Flow|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502165|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502166|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502167|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502168|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502169|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502170|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502171|NCT00347932|O2|Outcome|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502172|NCT00347932|O1|Outcome|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502173|NCT00347932|E2|Reported Event|Vehicle|Vehicle of intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502174|NCT00347932|E1|Reported Event|ISV-403|Intraocular 0.6% ISV-403 ophthalmic suspension administered three times daily to affected eyes for 5 days.
502175|NCT00347919|B4|Baseline|Total|Total of all reporting groups
502176|NCT00347919|B3|Baseline|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502177|NCT00347919|B2|Baseline|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502178|NCT00347919|B1|Baseline|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502179|NCT00347919|P3|Participant Flow|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502180|NCT00347919|P2|Participant Flow|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502181|NCT00347919|P1|Participant Flow|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502182|NCT00347919|O1|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502183|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502184|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502185|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502186|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/ Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502187|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502188|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502189|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502190|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502191|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502192|NCT00347919|O3|Outcome|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502193|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502194|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502195|NCT00347919|O2|Outcome|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502196|NCT00347919|O1|Outcome|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502197|NCT00347919|E3|Reported Event|Cohort 2: Lapatinib 1500 mg/Pazopanib 800 mg|Lapatinib 1500 mg and Pazopanib 800 mg administered orally once a day
502198|NCT00347919|E2|Reported Event|Cohort 1: Lapatinib 1000 mg/Pazopanib 400 mg|Lapatinib 1000 mg and Pazopanib 400 mg administered orally once a day
502199|NCT00347919|E1|Reported Event|Cohort 1: Lapatinib 1500 mg|Lapatinib 1500 milligrams (mg) administered orally once a day
502200|NCT00347438|B1|Baseline|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502201|NCT00347438|P1|Participant Flow|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502202|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502203|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502204|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502205|NCT00347438|O1|Outcome|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502206|NCT00347438|E1|Reported Event|Capecitabine|Planned treatment consisted of 24 weeks of capecitabine at a dose of 1000 mg/m^2 twice daily.
502207|NCT00347360|B16|Baseline|Total|Total of all reporting groups
502208|NCT00347360|B15|Baseline|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502209|NCT00347360|B14|Baseline|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502210|NCT00347360|B13|Baseline|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502211|NCT00347360|B12|Baseline|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502212|NCT00347360|B11|Baseline|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502213|NCT00347360|B10|Baseline|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502214|NCT00347360|B9|Baseline|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502215|NCT00347360|B8|Baseline|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502216|NCT00347360|B7|Baseline|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502217|NCT00347360|B6|Baseline|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502218|NCT00347360|B5|Baseline|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502219|NCT00347360|B4|Baseline|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502220|NCT00347360|B3|Baseline|Lisinopril 40|lisinopril 40 mg once daily
502221|NCT00347360|B2|Baseline|Lisinopril 20|lisinopril 20 mg once daily
502222|NCT00347360|B1|Baseline|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502223|NCT00347360|P15|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502224|NCT00347360|P14|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502225|NCT00347360|P13|Participant Flow|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502226|NCT00347360|P12|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502227|NCT00347360|P11|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502228|NCT00347360|P10|Participant Flow|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502229|NCT00347360|P9|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502230|NCT00347360|P8|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502231|NCT00347360|P7|Participant Flow|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502232|NCT00347360|P6|Participant Flow|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502233|NCT00347360|P5|Participant Flow|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502234|NCT00347360|P4|Participant Flow|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502235|NCT00347360|P3|Participant Flow|Lisinopril 40|lisinopril 40 mg once daily
502236|NCT00347360|P2|Participant Flow|Lisinopril 20|lisinopril 20 mg once daily
502237|NCT00347360|P1|Participant Flow|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502238|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502239|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502240|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502241|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502242|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502243|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502244|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502245|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502246|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502247|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502248|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502249|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502252|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502253|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502254|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502255|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502256|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502257|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502258|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502259|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502260|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502261|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502262|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502263|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502264|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502265|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502266|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502267|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502268|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502269|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502270|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502271|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502272|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502273|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502274|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502275|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502276|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502277|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502278|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502279|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502280|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502281|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502282|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502283|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502284|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502285|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502286|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502287|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502288|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502289|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502290|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502291|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502292|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502293|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502294|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502295|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502296|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502297|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502298|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502299|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502300|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502301|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502302|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502303|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502304|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502305|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502306|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502307|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502308|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502309|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502310|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502311|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502312|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502313|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502314|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502315|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502316|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502317|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502318|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502319|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502320|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502321|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502322|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502323|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502324|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502325|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502326|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502327|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502328|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502329|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502330|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502331|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502332|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502333|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502334|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502335|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502336|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502337|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502338|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502339|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502340|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502341|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502342|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502343|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502344|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502345|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502346|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502347|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502348|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502349|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502350|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502351|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502352|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502353|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502354|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502355|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502356|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502357|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502358|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502359|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502360|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502361|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502362|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502363|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502364|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502365|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502426|NCT00347022|P1|Participant Flow|Xenetix|Patient will receive one injection of Xenetix 300
502366|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502367|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502368|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502369|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502370|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502371|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502372|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502373|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502374|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502375|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502376|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502377|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502378|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502379|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502380|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502381|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502382|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502383|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502384|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502385|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502386|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502387|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502388|NCT00347360|O15|Outcome|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502389|NCT00347360|O14|Outcome|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502390|NCT00347360|O13|Outcome|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502391|NCT00347360|O12|Outcome|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502392|NCT00347360|O11|Outcome|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502393|NCT00347360|O10|Outcome|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502394|NCT00347360|O9|Outcome|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502395|NCT00347360|O8|Outcome|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502396|NCT00347360|O7|Outcome|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502397|NCT00347360|O6|Outcome|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502398|NCT00347360|O5|Outcome|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502399|NCT00347360|O4|Outcome|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502400|NCT00347360|O3|Outcome|Lisinopril 40|lisinopril 40 mg once daily
502401|NCT00347360|O2|Outcome|Lisinopril 20|lisinopril 20 mg once daily
502402|NCT00347360|O1|Outcome|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502403|NCT00347360|E15|Reported Event|Carvedilol Controlled Release 80 Lisinopril 40|carvedilol CR 80 mg plus lisinopril 40 mg once daily
502404|NCT00347360|E14|Reported Event|Carvedilol Controlled Release 80 Lisinopril 20|carvedilol CR 80 mg plus lisinopril 20 mg once daily
502405|NCT00347360|E13|Reported Event|Carvedilol Controlled Release 80 Lisinopril 10|carvedilol CR 80 mg plus lisinopril 10 mg once daily
502406|NCT00347360|E12|Reported Event|Carvedilol Controlled Release 40 Lisinopril 40|carvedilol CR 40 mg plus lisinopril 40 mg once daily
502407|NCT00347360|E11|Reported Event|Carvedilol Controlled Release 40 Lisinopril 20|carvedilol CR 40 mg plus lisinopril 20 mg once daily
502408|NCT00347360|E10|Reported Event|Carvedilol Controlled Release 40 Lisinopril 10|carvedilol CR 40 mg plus lisinopril 10 mg once daily
502409|NCT00347360|E9|Reported Event|Carvedilol Controlled Release 20 Lisinopril 40|carvedilol CR 20 mg plus lisinopril 40 mg once daily
502410|NCT00347360|E8|Reported Event|Carvedilol Controlled Release 20 Lisinopril 20|carvedilol CR 20 mg plus lisinopril 20 mg once daily
502411|NCT00347360|E7|Reported Event|Carvedilol Controlled Release 20 Lisinopril 10|carvedilol CR 20 mg plus lisinopril 10 mg once daily
502412|NCT00347360|E6|Reported Event|Carvedilol Controlled Release 80|carvedilol CR 80 mg once daily
502413|NCT00347360|E5|Reported Event|Carvedilol Controlled Release 40|carvedilol CR 40 mg once daily
502414|NCT00347360|E4|Reported Event|Carvedilol Controlled Release 20|carvedilol controlled release (CR) 20 mg once daily
502415|NCT00347360|E3|Reported Event|Lisinopril 40|lisinopril 40 mg once daily
502416|NCT00347360|E2|Reported Event|Lisinopril 20|lisinopril 20 mg once daily
502417|NCT00347360|E1|Reported Event|Lisinopril 10|lisinopril 10 milligrams (mg) once daily
502418|NCT00347308|B1|Baseline|Group 1|All patients entered into the study
502419|NCT00347308|P1|Participant Flow|Group 1|All patients entered into the study
502420|NCT00347308|O1|Outcome|Group 1|All patients entered into the study
502421|NCT00347308|E1|Reported Event|Group 1|All patients entered into the study
502422|NCT00347022|B3|Baseline|Total|Total of all reporting groups
502423|NCT00347022|B2|Baseline|Visipaque|Patient will be injected with Visipaque 270
502424|NCT00347022|B1|Baseline|Xenetix|Patient will be injected with Xenetix 300
502425|NCT00347022|P2|Participant Flow|Visipaque|Patient will receive one injection of Visipaque 270
502427|NCT00347022|O2|Outcome|Visipaque|Patient will receive one injection of Visipaque 270
502428|NCT00347022|O1|Outcome|Xenetix|Patient will receive one injection of Xenetix 300
502429|NCT00347022|E2|Reported Event|Vispaque|Patient will be injected with Visipaque 270
502430|NCT00347022|E1|Reported Event|Xenetix|Patient will be injected with Xenetix 300
502431|NCT00347009|B1|Baseline|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502432|NCT00347009|P1|Participant Flow|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502433|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502434|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502435|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502436|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502437|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502438|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502439|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502440|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502441|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502442|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502443|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502444|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502445|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502446|NCT00347009|O1|Outcome|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502447|NCT00347009|E1|Reported Event|Adefovir Dipivoxil 10 Milligrams (mg)|Adefovir Dipivoxil 10 mg, once daily
502448|NCT00345683|B3|Baseline|Total|Total of all reporting groups
502449|NCT00345683|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502450|NCT00345683|B1|Baseline|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502451|NCT00345683|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502452|NCT00345683|P1|Participant Flow|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502453|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502454|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502455|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502456|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502457|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502540|NCT00346697|P1|Participant Flow|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502458|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502459|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502460|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502461|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502462|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502463|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502464|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502465|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502466|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502467|NCT00345683|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502468|NCT00345683|O1|Outcome|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502469|NCT00345683|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in this study (study Month 10-13). ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502470|NCT00345683|E1|Reported Event|Menhibrix Group|Subjects received 3 doses of Menhibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course in the study NCT00345579 and a fourth dose of Menhibrix vaccine at 12-15 months of age in this study (study Month 10-13). Menhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502471|NCT00345631|B4|Baseline|Total|Total of all reporting groups
502472|NCT00345631|B3|Baseline|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502473|NCT00345631|B2|Baseline|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502474|NCT00345631|B1|Baseline|Roll-In|Roll-In patients were device training patients
502475|NCT00345631|P3|Participant Flow|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502476|NCT00345631|P2|Participant Flow|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502477|NCT00345631|P1|Participant Flow|Roll-In|Roll-In patients were device training patients
502478|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502479|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502480|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502481|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502482|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502483|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502484|NCT00345631|O3|Outcome|Manual Compression (Not Applicable for Device Success)|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502485|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502486|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502487|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502488|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502489|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502490|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502491|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502492|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502493|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502494|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502495|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502496|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502497|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502498|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502499|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502500|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502501|NCT00345631|O1|Outcome|Roll-In|Roll-In patients were device training patients
502502|NCT00345631|O3|Outcome|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502503|NCT00345631|O2|Outcome|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502504|NCT00345631|O1|Outcome|Roll-In|patients were device training patients
502505|NCT00345631|E3|Reported Event|Manual Compression|Traditionally Hemostasis at the femoral artery access site after diagnostic or interventional procedures is typically achieved using either manual compression (with or without the use of adjunctive mechanical compression devices)
502506|NCT00345631|E2|Reported Event|Vascular Closure Device|Ensure Medical Vascular Closure Device (VCD) have been developed to avoid manual compression, shorten bed rest, and allow earlier ambulation.
502507|NCT00345631|E1|Reported Event|Roll-In|Roll-In patients were device training patients
502508|NCT00345605|B1|Baseline|High-dose Arginine vs Low-dose Arginine Plus Buphenyl|
502509|NCT00345605|P2|Participant Flow|Low Dose First|low dose arm 3 day wash-out followed by 7 days of: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA interval then: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA
502510|NCT00345605|P1|Participant Flow|High Dose First|High dose arm 3 day wash-out followed by 7 days of: Arg 500 mg/kg/d or 10 g/m2 BSA Placebo instead of NaPBA interval then: Arg 100 mg/kg/d or 2 g/m2 BSA NaPBA 500 mg/kg/d or 10 g/m2 BSA
502541|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502511|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
502512|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
502513|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
502514|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
502515|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
502516|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
502517|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
502518|NCT00345605|O1|Outcome|High-dose Arginine Alone|
502519|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
502520|NCT00345605|O1|Outcome|High-dose Arginine Alone|
502521|NCT00345605|O2|Outcome|Low-dose Arginine Plus Buphenyl|
502522|NCT00345605|O1|Outcome|High-dose Arginine Alone|
502523|NCT00345605|O2|Outcome|High Dose Arginine Alone|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of arginine alone; a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine
502524|NCT00345605|O1|Outcome|Low-dose Arginine Plus Buphenyl|Participants will undergo treatments in the following order: a 3-day washout period; a 1-week treatment period of sodium phenylbutyrate (Buphenyl-TM) plus arginine; a 3-day washout period; a 1-week treatment period of arginine alone.
502525|NCT00345605|E2|Reported Event|Low-dose Arginine Plus Buphenyl|
502526|NCT00345605|E1|Reported Event|High-dose Arginine Alone|
502527|NCT00345592|B3|Baseline|Total|Total of all reporting groups
502528|NCT00345592|B2|Baseline|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
502529|NCT00345592|B1|Baseline|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
502530|NCT00345592|P2|Participant Flow|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
502531|NCT00345592|P1|Participant Flow|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
502532|NCT00345592|O2|Outcome|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
502533|NCT00345592|O1|Outcome|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
502534|NCT00345592|E2|Reported Event|Traditional Arm|"Traditional therapy arm. In this arm, therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment. Therefore, patients who will experience symptoms at home, will refer to their center, eventually hospitalized and treated for atrial arrhythmias.~Dual (atrial and ventricular) implantable defibrillator: In hospital application of anti arrhythmic therapies via the device~Dual (atrial and ventricular) implantable defibrillator: Therapy for atrial arrhythmias will be delivered from the device through command of the physician and in a hospital environment"
502535|NCT00345592|E1|Reported Event|Device Managed Arm|"Device-managed therapy arm. Shock therapy for atrial arrhythmias is delivered automatically from the device.~Dual (atrial and ventricular) implantable defibrillator: The devices automatically applies therapy (shock) for atrial fibrillation, when atrial fibrillation is confirmed."
502536|NCT00346697|B3|Baseline|Total|Total of all reporting groups
502537|NCT00346697|B2|Baseline|Placebo|Corn oil placebo, plus dietary counselling
502538|NCT00346697|B1|Baseline|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502539|NCT00346697|P2|Participant Flow|Placebo|Corn oil placebo, plus dietary counselling
502542|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502543|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502544|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502545|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502546|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502547|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502548|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502549|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502550|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502551|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502552|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502553|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502554|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502555|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502556|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502557|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502558|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502559|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502560|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502561|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502562|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502563|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502564|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502565|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502566|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502567|NCT00346697|O2|Outcome|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502568|NCT00346697|O1|Outcome|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502569|NCT00346697|O2|Outcome|Placebo|Corn oil placebo, plus dietary counselling
502570|NCT00346697|O1|Outcome|LOVAZA|4 g/d of omega-3 fatty acid esters, plus dietary counseling
502571|NCT00346697|E2|Reported Event|Placebo|"Corn oil placebo, plus dietary counselling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502572|NCT00346697|E1|Reported Event|LOVAZA|"4 g/d of omega-3 fatty acid esters, plus dietary counseling~Omega-3 fatty acid administration: LOVAZA 1 gram capsules, 4 capsules daily"
502573|NCT00346632|B3|Baseline|Total|Total of all reporting groups
502574|NCT00346632|B2|Baseline|Arm B: KW-2449 28-day Regimen|Sequential ascending oral doses of KW-2449 given for 28-day cycles
502575|NCT00346632|B1|Baseline|Arm A: KW-2449 14-day Regimen|Sequential ascending oral doses of KW-2449 given for 14-day cycles
502576|NCT00346632|P10|Participant Flow|100 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
502577|NCT00346632|P9|Participant Flow|50 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
502578|NCT00346632|P8|Participant Flow|25 mg/Day KW-2449 28-day Regimen (Arm B)|Arm B has sequential ascending oral doses of KW-2449 given for 28-day cycles
502579|NCT00346632|P7|Participant Flow|500 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502580|NCT00346632|P6|Participant Flow|400 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502581|NCT00346632|P5|Participant Flow|300 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502582|NCT00346632|P4|Participant Flow|200 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502583|NCT00346632|P3|Participant Flow|100 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502584|NCT00346632|P2|Participant Flow|50 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502585|NCT00346632|P1|Participant Flow|25 mg/Day KW-2449 14-day Regimen (Arm A)|Arm A has sequential ascending oral doses of KW-2449 given for 14-day cycles
502586|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
502587|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
502588|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
502589|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
502590|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
502591|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
502592|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
502593|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
502594|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
502595|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
502596|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
502597|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
502598|NCT00346632|O13|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
502599|NCT00346632|O12|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
502600|NCT00346632|O11|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
502601|NCT00346632|O10|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
502602|NCT00346632|O9|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
502603|NCT00346632|O8|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
502604|NCT00346632|O7|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
502605|NCT00346632|O6|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
502606|NCT00346632|O5|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
502607|NCT00346632|O4|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
502608|NCT00346632|O3|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
502609|NCT00346632|O2|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
502610|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
502611|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
502612|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
502613|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502614|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
502615|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
502616|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
502617|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
502618|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
502619|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
502620|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
502621|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
502622|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
502623|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
502624|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
502625|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
502626|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
502627|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
502628|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
502629|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502630|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
502631|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
502632|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
502633|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
502634|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
502635|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
502636|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502637|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
502638|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
502639|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
502640|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
502641|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
502642|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
502643|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
502644|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
502645|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
502646|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
502647|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
502648|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
502649|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
502650|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
502651|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
502652|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502653|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
502654|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
502655|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
502656|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
502657|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
502658|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
502659|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502660|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
502661|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
511399|NCT00319553|E1|Reported Event|Adacel® Vaccine Group|
502662|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
502663|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
502664|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
502665|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
502666|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
502667|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
502668|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
502669|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
502670|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
502671|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
502672|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
502673|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
502674|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
502675|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502676|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
502677|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
502678|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
502679|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
502680|NCT00346632|O23|Outcome|Arm B - 100 mg/Day: Day 28|KW2449-001 100 mg/day (Treatment Arm B)
502681|NCT00346632|O22|Outcome|Arm B - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm B)
502682|NCT00346632|O21|Outcome|Arm B - 100 mg.Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502683|NCT00346632|O20|Outcome|Arm B - 50 mg/Day: Day 28|KW2449-001 50 mg/day (Treatment Arm B)
502684|NCT00346632|O19|Outcome|Arm B - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm B)
502685|NCT00346632|O18|Outcome|Arm B - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm B)
502686|NCT00346632|O17|Outcome|Arm B - 25 mg/Day: Day 28|KW2449-001 25 mg/day (Treatment Arm B)
502687|NCT00346632|O16|Outcome|Arm B - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm B)
502688|NCT00346632|O15|Outcome|Arm B - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm B)
502689|NCT00346632|O14|Outcome|Arm A - 500 mg/Day: Day 14|KW2449-001 500 mg/day (Treatment Arm A)
502690|NCT00346632|O13|Outcome|Arm A - 500 mg/Day: Day 1|KW2449-001 500 mg/day (Treatment Arm A)
502691|NCT00346632|O12|Outcome|Arm A - 400 mg/Day: Day 14|KW2449-001 400 mg/day (Treatment Arm A)
502692|NCT00346632|O11|Outcome|Arm A - 400 mg/Day: Day 1|KW2449-001 400 mg/day (Treatment Arm A)
502693|NCT00346632|O10|Outcome|Arm A - 300 mg/Day: Day 14|KW2449-001 300 mg/day (Treatment Arm A)
502694|NCT00346632|O9|Outcome|Arm A - 300 mg/Day: Day 1|KW2449-001 300 mg/day (Treatment Arm A)
502695|NCT00346632|O8|Outcome|Arm A - 200 mg/Day: Day 14|KW2449-001 200 mg/day (Treatment Arm A)
502696|NCT00346632|O7|Outcome|Arm A - 200 mg/Day: Day 1|KW2449-001 200 mg/day (Treatment Arm A)
502697|NCT00346632|O6|Outcome|Arm A - 100 mg/Day: Day 14|KW2449-001 100 mg/day (Treatment Arm A)
502698|NCT00346632|O5|Outcome|Arm A - 100 mg/Day: Day 1|KW2449-001 100 mg/day (Treatment Arm A)
502699|NCT00346632|O4|Outcome|Arm A - 50 mg/Day: Day 14|KW2449-001 50 mg/day (Treatment Arm A)
502700|NCT00346632|O3|Outcome|Arm A - 50 mg/Day: Day 1|KW2449-001 50 mg/day (Treatment Arm A)
502701|NCT00346632|O2|Outcome|Arm A - 25 mg/Day: Day 14|KW2449-001 25 mg/day (Treatment Arm A)
502702|NCT00346632|O1|Outcome|Arm A - 25 mg/Day: Day 1|KW2449-001 25 mg/day (Treatment Arm A)
502703|NCT00346632|O12|Outcome|Arm B - Total|Total Patients in Treatment Arm B
502704|NCT00346632|O11|Outcome|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
502705|NCT00346632|O10|Outcome|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
502706|NCT00346632|O9|Outcome|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
502707|NCT00346632|O8|Outcome|Arm A - Total|Total Patients in Treatment Arm A
502708|NCT00346632|O7|Outcome|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
502709|NCT00346632|O6|Outcome|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
502710|NCT00346632|O5|Outcome|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
502711|NCT00346632|O4|Outcome|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
502712|NCT00346632|O3|Outcome|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
502713|NCT00346632|O2|Outcome|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
502714|NCT00346632|O1|Outcome|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
502715|NCT00346632|E12|Reported Event|Arm B - Total|Total Patients in Treatment Arm B
502716|NCT00346632|E11|Reported Event|Arm B - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm B)
502717|NCT00346632|E10|Reported Event|Arm B - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm B)
502718|NCT00346632|E9|Reported Event|Arm B - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm B)
502719|NCT00346632|E8|Reported Event|Arm A - Total|Total Patients in Treatment Arm A
502720|NCT00346632|E7|Reported Event|Arm A - 500 mg/Day|KW2449-001 500 mg/day (Treatment Arm A)
502721|NCT00346632|E6|Reported Event|Arm A - 400 mg/Day|KW2449-001 400 mg/day (Treatment Arm A)
502722|NCT00346632|E5|Reported Event|Arm A - 300 mg/Day|KW2449-001 300 mg/day (Treatment Arm A)
502723|NCT00346632|E4|Reported Event|Arm A - 200 mg/Day|KW2449-001 200 mg/day (Treatment Arm A)
502724|NCT00346632|E3|Reported Event|Arm A - 100 mg/Day|KW2449-001 100 mg/day (Treatment Arm A)
502725|NCT00346632|E2|Reported Event|Arm A - 50 mg/Day|KW2449-001 50 mg/day (Treatment Arm A)
502726|NCT00346632|E1|Reported Event|Arm A - 25 mg/Day|KW2449-001 25 mg/day (Treatment Arm A)
502727|NCT00346476|B1|Baseline|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
502728|NCT00346476|P1|Participant Flow|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
502729|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
502730|NCT00346476|O1|Outcome|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
502731|NCT00346476|E1|Reported Event|Participants|Individuals in the Masiphumelele Township of Cape Town, South Africa, who have been potentially exposed to TB and/or HIV
502732|NCT00346398|B3|Baseline|Total|Total of all reporting groups
502733|NCT00346398|B2|Baseline|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502734|NCT00346398|B1|Baseline|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502735|NCT00346398|P2|Participant Flow|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502736|NCT00346398|P1|Participant Flow|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502737|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502738|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502739|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502740|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502741|NCT00346398|O2|Outcome|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502742|NCT00346398|O1|Outcome|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502743|NCT00346398|E2|Reported Event|Placebo|Participants were administered via the same route as the experimental group an oral placebo solution daily for 12 months. The placebo consisted of three 0.2 mL vials of solution mixed together for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502744|NCT00346398|E1|Reported Event|OMIP With Timothy Grass, Cat and House Dust Mite Allergens|Participants were administered oral mucosal immunoprophylaxis (OMIP) daily for 12 months. OMIP consisted of a mixture of allergen extracts including 0.2 milliliters (mL) timothy grass, 0.2 mL cat, and 0.2 mL house dust mite for a total daily dose of 0.6 mL. After 12 months, treatment stopped and participants were tested 3 years after end of treatment for development of allergic sensitization and asthma.
502745|NCT00346333|B3|Baseline|Total|Total of all reporting groups
502746|NCT00346333|B2|Baseline|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A palmitate daily
502747|NCT00346333|B1|Baseline|Control Plus Vitamin A|cornstarch control plus 15,000IU Vitamin A palmitate daily
502748|NCT00346333|P2|Participant Flow|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502749|NCT00346333|P1|Participant Flow|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502750|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502751|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502752|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502753|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502754|NCT00346333|O2|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502755|NCT00346333|O1|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502756|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502757|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502758|NCT00346333|O2|Outcome|Lutein Plus Vitamin A|12mg Lutein plus 15,000 IU Vitamin A palmitate daily
502759|NCT00346333|O1|Outcome|Control Plus Vitamin A|cornstarch control plus 15,000 IU Vitamin A palmitate daily
502760|NCT00346333|E2|Reported Event|Lutein Plus Vitamin A|12mg Lutein plus 15,000IU Vitamin A daily.
502761|NCT00346333|E1|Reported Event|Control Plus Vitamin A|Daily intake of cornstarch control plus 15,000IU Vitamin A palmitate
502762|NCT00346268|B3|Baseline|Total|Total of all reporting groups
502763|NCT00346268|B2|Baseline|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502764|NCT00346268|B1|Baseline|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502765|NCT00346268|P2|Participant Flow|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502766|NCT00346268|P1|Participant Flow|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502767|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502768|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502769|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502770|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502771|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502772|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502773|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502774|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502775|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502776|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502777|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502778|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502779|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502780|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502807|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
511400|NCT00319501|B3|Baseline|Total|Total of all reporting groups
502781|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502782|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502783|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502784|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502785|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502786|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502787|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502788|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502789|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502790|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502791|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502792|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502793|NCT00346268|O2|Outcome|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502794|NCT00346268|O1|Outcome|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502795|NCT00346268|E2|Reported Event|Placebo and Morphine|Matching placebo administered intravenously immediately post surgery and every 12 hours until 48 hours post surgery, total 5 doses. Participants also received PCA (1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502796|NCT00346268|E1|Reported Event|Parecoxib and Morphine|Parecoxib 40 milligrams (mg) administered intravenously immediately post surgery, followed 20 mg every 12 hours until 48 hours post surgery, total 5 doses. Participants also received Patient-Controlled Analgesia (PCA) 1 mg per dose, maximum 40 mg/4 hours, and if necessary, bolus (2 to 5 mg) before or after enabled PCA.
502797|NCT00346151|B1|Baseline|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502798|NCT00346151|P1|Participant Flow|Belatacept|Immunosuppressive protocol consisting of belatacept, glucocorticoids, antithymocyte globulin (ATG), and sirolimus.
502799|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502800|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502801|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502802|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502803|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502804|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502805|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502806|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
512756|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
502808|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502809|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502810|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502811|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502812|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502813|NCT00346151|O1|Outcome|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502814|NCT00346151|E1|Reported Event|Immunosuppression Withdrawal|Daclizumab, antithymocyte globulin, sirolimus, or belatacept dosing with the intention of immunosuppression withdrawal
502815|NCT00346034|B1|Baseline|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
502816|NCT00346034|P1|Participant Flow|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
502817|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
502818|NCT00346034|O1|Outcome|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
502819|NCT00346034|E1|Reported Event|Pregabalin|Subjects began the open-label study (A0081101) medication the morning after termination visit from double-blind study (A0081100) at a fixed dose of 300 mg/day. Pregabalin daily dose was adjusted thereafter by the investigator to optimize pain control and to minimize adverse events. Adjustments to total daily doses were permitted for the remainder of the study. The minimum permissible daily dose was 150 mg/day (75 mg BID) and the maximum daily dose was 600 mg/day (300 mg BID) of pregabalin.
502820|NCT00345878|B3|Baseline|Total|Total of all reporting groups
502821|NCT00345878|B2|Baseline|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502822|NCT00345878|B1|Baseline|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502823|NCT00345878|P2|Participant Flow|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502824|NCT00345878|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502825|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502826|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502827|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502828|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502829|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502830|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502831|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502832|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502833|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502834|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502835|NCT00345878|O2|Outcome|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502836|NCT00345878|O1|Outcome|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502837|NCT00345878|E2|Reported Event|Placebo Group|Subjects received 3 doses of Placebo according to a 0, 1, 6-month schedule.
502838|NCT00345878|E1|Reported Event|Cervarix Group|Subjects received 3 doses of HPV-16/18 L1 VLP AS04 (Cervarix™) according to a 0, 1, 6-month schedule.
502839|NCT00345839|B3|Baseline|Total|Total of all reporting groups
502840|NCT00345839|B2|Baseline|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502841|NCT00345839|B1|Baseline|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502842|NCT00345839|P2|Participant Flow|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
512757|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
502843|NCT00345839|P1|Participant Flow|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502844|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502845|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502846|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502847|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502848|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502849|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502850|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502851|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502852|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502853|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502854|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502855|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502856|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502857|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502858|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502859|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502860|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502861|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502862|NCT00345839|O2|Outcome|Placebo|Participants were given matching placebo tablets compared to the cinacalcet group.
502863|NCT00345839|O1|Outcome|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502864|NCT00345839|E2|Reported Event|Cinacalcet|Cinacalcet administered orally in doses of 30, 60, 90, 120 or 180 mg per day. Participants could be titrated up to maximum dose based on PTH (parathyroid hormone), serum calcium and safety assessments.
502865|NCT00345839|E1|Reported Event|Placebo|
502866|NCT00345579|B3|Baseline|Total|Total of all reporting groups
502867|NCT00345579|B2|Baseline|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502868|NCT00345579|B1|Baseline|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502869|NCT00345579|P2|Participant Flow|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502870|NCT00345579|P1|Participant Flow|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502871|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502954|NCT00345176|E1|Reported Event|Placebo/Control|Considered control because all participants received the AREDS formulation
502955|NCT00345046|B4|Baseline|Total|Total of all reporting groups
503017|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503018|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
502872|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHhibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502873|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502874|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502875|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502876|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502877|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502878|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502879|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502880|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502881|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502882|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502883|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502884|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502885|NCT00345579|O2|Outcome|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502886|NCT00345579|O1|Outcome|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
503014|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
502887|NCT00345579|E2|Reported Event|ActHIB Group|Subjects received 3 doses of ActHIB vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and 1 dose of PedvaxHib vaccine as a booster at 12-15 months of age in the study NCT00345683. ActHIB and PedvaxHib vaccines were administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502888|NCT00345579|E1|Reported Event|MenHibrix Group|Subjects received 3 doses of MenHibrix vaccine (at 2, 4 and 6 months of age, study Months 0, 2 and 4), co-administered with Pediarix/Infanrix penta as a primary vaccination course and a fourth dose of MenHibrix vaccine at 12-15 months of age in the study NCT00345683. MenHibrix was administered intramuscularly in the upper right thigh and co-administered Pediarix/Infanrix penta vaccine was injected intramuscularly in the upper left thigh.
502889|NCT00345540|B1|Baseline|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502890|NCT00345540|P1|Participant Flow|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502891|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502892|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502893|NCT00345540|O1|Outcome|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502894|NCT00345540|E1|Reported Event|NOV-002 Plus Carboplatin|NOV-002 is given by IV bolus on lead-in day -1 at cycle 1, and on day 1 at subsequent cycles, followed by Carboplatin AUC 5. NOV-002 is then continued via daily SC injection, with 28 day cycles.
502895|NCT00345397|B1|Baseline|Subjects Receiving Percutaneous Endoscopic Colostomy (PEC)|Quality of Life (QOL) evaluation before and after device placement
502896|NCT00345397|P1|Participant Flow|Subjects Receiving PEC Tube|All Enrolled Subjects receiving PEC Placement
502897|NCT00345397|O2|Outcome|SCI-Specific QoL Evaluation in Subjects Receiving PEC Tube|SCI-Specific QoL evaluation before and after device placement
502898|NCT00345397|O1|Outcome|Global SCI-QoL Score in Subjects Receiving PEC Tube|Global SCI-QoL Score before and after device placement
502899|NCT00345397|E1|Reported Event|Subjects Receiving PEC Tube|QoL evaluation before and after device placement
502900|NCT00345384|B3|Baseline|Total|Total of all reporting groups
502901|NCT00345384|B2|Baseline|Dexmedetomidine|titrated IV for 24 hours post ICU
502902|NCT00345384|B1|Baseline|Normal Saline|Standard of care
502903|NCT00345384|P2|Participant Flow|Dexmedetomidine|Received Dexmedetomidine for 24 hours
502904|NCT00345384|P1|Participant Flow|Normal Saline|Blinded Normal saline infusion titrated as if study drug
502905|NCT00345384|O2|Outcome|Dexmedetomidine|"Study group to receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 30 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU~Dexmedetomidine: Dexmedetomidine titrated over 24 hours"
502906|NCT00345384|O1|Outcome|Placebo|Control group to receive a normal saline infusion, set at a rate as if it were the active drug.
502907|NCT00345384|O2|Outcome|Dexmedetomidine|Patient group to receive Dexmedetomidine.
502908|NCT00345384|O1|Outcome|Placebo|Patient group to receive placebo (saline).
502909|NCT00345384|E2|Reported Event|Study Drug Group|Dexmedetomidine titrated IV from 0.1 microgram/kg/h upto 0.5 microgram/kg/h to control pain for 24 hours post ICU
502910|NCT00345384|E1|Reported Event|Normal Saline Group|Normal saline infused at calculated rate as if it were study drug
502911|NCT00345293|B1|Baseline|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
502912|NCT00345293|P2|Participant Flow|DC/PC3- Adherent|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using the adherence method.
502913|NCT00345293|P1|Participant Flow|DC/PC3 Vaccine-selected|3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and 2) pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and 3) pulsed with KLH (control antigen). Maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 10^6 DCs. DCs were made from precursors isolated using antibodies.
502914|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
503015|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503016|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
502915|NCT00345293|O2|Outcome|DC/PC3- Adherent|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from the adherent subset of peripheral blood mononuclear cells."
502916|NCT00345293|O1|Outcome|DC/PC3 Vaccine- Selected|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells (control apoptotic cells) and pulsed with KLH (control antigen).~Dendritic cells were made from antibody selected cells."
502917|NCT00345293|O1|Outcome|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
502918|NCT00345293|E1|Reported Event|DC/PC3 Vaccine|"3 subcutaneous injections of ex vivo-generated autologous dendritic cell vaccine: 1) pulsed with apoptotic PC3 cells; 2) pulsed with apoptotic PC3-M1 cells, and 3) pulsed with keyhole limpet hemocyanin (KLH, control antigen)~autologous dendritic cell vaccine (DC/PC3): ex vivo generated autologous dendritic cells pulsed with apoptotic PC3 cells and pulsed with apoptotic PC3-M1 cells(control apoptotic cells) and pulsed with KLH (control antigen). maximum dose of DC/PC3 that we are able to generate from their initial leukaphereses product, up to a maximum of 10 x 106 DCs. Doses in the range of 105 to 10 x 106 DCs have been used clinically without toxicity"
502919|NCT00345254|B3|Baseline|Total|Total of all reporting groups
502920|NCT00345254|B2|Baseline|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
502921|NCT00345254|B1|Baseline|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
502922|NCT00345254|P2|Participant Flow|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
502923|NCT00345254|P1|Participant Flow|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
502924|NCT00345254|O2|Outcome|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
502925|NCT00345254|O1|Outcome|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
502926|NCT00345254|E2|Reported Event|Untouched Cord|The cord was untouched after delivery of the anterior shoulder and prior to extraction of the body.
502927|NCT00345254|E1|Reported Event|Severing Cord|"The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body.~severing cord: The cord was cut intentionally after delivery of the anterior shoulder and prior to extraction of the body."
502928|NCT00345176|B5|Baseline|Total|Total of all reporting groups
502929|NCT00345176|B4|Baseline|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502930|NCT00345176|B3|Baseline|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502931|NCT00345176|B2|Baseline|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
502932|NCT00345176|B1|Baseline|Placebo/Control|Considered control because all participants received the AREDS formulation
502933|NCT00345176|P4|Participant Flow|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502934|NCT00345176|P3|Participant Flow|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502935|NCT00345176|P2|Participant Flow|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
502936|NCT00345176|P1|Participant Flow|Placebo/Control|Considered control because all participants received the AREDS formulation
502937|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|Lutein main effect - includes all participants who received Lutein/Zeaxanthin
502938|NCT00345176|O1|Outcome|No Lutein/Zeaxanthin|Lutein main effect - includes participants who did not receive Lutein/Zeaxanthin
502939|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502940|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502941|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
502942|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
502943|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502944|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502945|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
502946|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
502947|NCT00345176|O4|Outcome|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502948|NCT00345176|O3|Outcome|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502949|NCT00345176|O2|Outcome|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
502950|NCT00345176|O1|Outcome|Placebo/Control|Considered control because all participants received the AREDS formulation
502951|NCT00345176|E4|Reported Event|Lutein/Zeaxanthin + DHA/EPA|lutein (10 mg)/zeaxanthin (2 mg) + DHA (350 mg)/EPA (650 mg)
502952|NCT00345176|E3|Reported Event|DHA/EPA|DHA (350 mg)/EPA (650 mg)
502953|NCT00345176|E2|Reported Event|Lutein/Zeaxanthin|lutein (10mg)/zeaxanthin (2 mg)
512758|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
502956|NCT00345046|B3|Baseline|Prednisolone Acetate|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
502957|NCT00345046|B2|Baseline|EconoPred Plus|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
502958|NCT00345046|B1|Baseline|Pred Forte|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
502959|NCT00345046|P3|Participant Flow|Prednisolone Acetate 1%|Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
502960|NCT00345046|P2|Participant Flow|EconPred Plus 1%|EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.
502961|NCT00345046|P1|Participant Flow|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
502962|NCT00345046|O3|Outcome|Predisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
502963|NCT00345046|O2|Outcome|Econo Pred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
502964|NCT00345046|O1|Outcome|Pred Forte 1%|Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.
502965|NCT00345046|E3|Reported Event|Prednisolone Acetate 1%|"Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.~Prednisolone Acetate: Dosed four times daily decreasing to once daily over four weeks."
502966|NCT00345046|E2|Reported Event|EconoPred Plus 1%|"EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks.~EconoPred Plus: Prednisolone Acetate four times daily decreasing to once daily over four weeks."
502967|NCT00345046|E1|Reported Event|Pred Forte 1%|"Pred Forte 1% dosed four times daily decreasing to once daily over four weeks.~Pred Forte: Four drops daily decreasing to once daily over four weeks."
502968|NCT00345033|B3|Baseline|Total|Total of all reporting groups
502969|NCT00345033|B2|Baseline|Placebo|Participants will take placebo for 8 weeks.
502970|NCT00345033|B1|Baseline|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502971|NCT00345033|P2|Participant Flow|Placebo|Participants will take placebo for 8 weeks.
502972|NCT00345033|P1|Participant Flow|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502973|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502974|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502975|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502976|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502977|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502978|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502979|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502980|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502981|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502982|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502983|NCT00345033|O2|Outcome|Placebo|Participants will take placebo for 8 weeks.
502984|NCT00345033|O1|Outcome|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502985|NCT00345033|E2|Reported Event|Placebo|Participants will take placebo for 8 weeks.
502986|NCT00345033|E1|Reported Event|Aripiprazole|Participants will take aripiprazole for 8 weeks.
502987|NCT00344968|B4|Baseline|Total|Total of all reporting groups
502988|NCT00344968|B3|Baseline|0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
502989|NCT00344968|B2|Baseline|0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
502990|NCT00344968|B1|Baseline|Sham Comparator|Procedure: Standard of care laser photocoagulation
502991|NCT00344968|P3|Participant Flow|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
502992|NCT00344968|P2|Participant Flow|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
502993|NCT00344968|P1|Participant Flow|Sham Comparator|Procedure: Standard of care laser photocoagulation
502994|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
502995|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur Implant
502996|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
502997|NCT00344968|O3|Outcome|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
502998|NCT00344968|O2|Outcome|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
502999|NCT00344968|O1|Outcome|Sham Comparator|Procedure: Standard of care laser photocoagulation
503000|NCT00344968|E3|Reported Event|Fluocinolone Acetonide: 0.5 ug/Day Implant|Dose 0.5 ug/day Medidur implant
503001|NCT00344968|E2|Reported Event|Fluocinolone Acetonide: 0.2 ug/Day Implant|Dose 0.2 ug/day Medidur implant
503002|NCT00344968|E1|Reported Event|Sham Comparator|Standard of care laser photocoagulation
503003|NCT00344773|B1|Baseline|Gefitinib|Gefitinib 250mg tablet
503004|NCT00344773|P1|Participant Flow|Gefitinib|Gefitinib 250mg tablet
503005|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
503006|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
503007|NCT00344773|O1|Outcome|Gefitinib|Gefitinib 250mg tablet
503008|NCT00344773|E1|Reported Event|Gefitinib|Gefitinib 250mg tablet
503009|NCT00344682|B3|Baseline|Total|Total of all reporting groups
503010|NCT00344682|B2|Baseline|Memantine|memantine : memantine 5mg - 20mg PO daily
503011|NCT00344682|B1|Baseline|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503012|NCT00344682|P2|Participant Flow|Memantine|memantine : memantine 5mg - 20mg PO daily
503013|NCT00344682|P1|Participant Flow|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
512759|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
503019|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503020|NCT00344682|O2|Outcome|Memantine|memantine : memantine 5mg - 20mg PO daily
503021|NCT00344682|O1|Outcome|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503022|NCT00344682|E2|Reported Event|Memantine|memantine : memantine 5mg - 20mg PO daily
503023|NCT00344682|E1|Reported Event|Placebo|Placebo comparator : 5mg - 20mg PO daily over 8 weeks
503024|NCT00344500|B3|Baseline|Total|Total of all reporting groups
503025|NCT00344500|B2|Baseline|Lifestyle Balance|Weight management education and counseling
503026|NCT00344500|B1|Baseline|Usual Care|Usual Care control group
503027|NCT00344500|P3|Participant Flow|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
503028|NCT00344500|P2|Participant Flow|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
503029|NCT00344500|P1|Participant Flow|Usual Care|Usual Care control group
503030|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
503031|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
503032|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
503033|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
503034|NCT00344500|O2|Outcome|Lifestyle Balance (LB)|Behavioral Weight Loss Program
503035|NCT00344500|O1|Outcome|Usual Care (UC)|Usual Care control group
503036|NCT00344500|E3|Reported Event|Changeover|Participants originally randomized to Usual Care who were allowed to change over to Lifestyle Balance at month 6 per their request.
503037|NCT00344500|E2|Reported Event|Lifestyle Balance|"Weight management education and counseling~Behavioral Weight Loss Program: Patients randomized to the behavioral weight loss program (Lifestyle Balance Program) will do the following: -Meet with their psychiatrist and a nutritionist who will go over diet recommendations with the patient~Be given a 7% weight loss goal~Be assisted in obtaining a 500 calorie reduction per day~Exercise for at least 30 min/day, at least 5 days a week~Maintain weekly food and exercise diaries~Be quizzed on their knowledge of healthy eating habits and nutrition"
503038|NCT00344500|E1|Reported Event|Usual Care|Usual Care control group
503039|NCT00344487|B1|Baseline|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mgby mouth twice a day for 48 weeks
503040|NCT00344487|P1|Participant Flow|Kaletra|Lopinavir/Ritonavir (Kaletra) 400/100 mg by mouth twice a day for 48 weeks.
503041|NCT00344487|O1|Outcome|Kaletra|
503042|NCT00344487|E1|Reported Event|Group 1|
503043|NCT00344448|B3|Baseline|Total|Total of all reporting groups
503044|NCT00344448|B2|Baseline|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
503045|NCT00344448|B1|Baseline|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
503046|NCT00344448|P2|Participant Flow|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
503047|NCT00344448|P1|Participant Flow|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
503048|NCT00344448|O2|Outcome|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
503049|NCT00344448|O1|Outcome|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
503050|NCT00344448|E2|Reported Event|Placebo|Weekly subcutaneous injection of a placebo (formulated to match the commercial vial of Raptiva in appearance and content except for the active ingredient) for the first 12 weeks of the study.
503051|NCT00344448|E1|Reported Event|Raptiva|At the beginning of the first (week 1) and second (week 13) phases, all patients will receive reduced dose of the study medication determined at 0.7 mg/kg/week. During all the subsequent administrations, all patients will receive full dose of the study medication determined at 1 mg/kg/week.
503052|NCT00344370|B3|Baseline|Total|Total of all reporting groups
503053|NCT00344370|B2|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
503054|NCT00344370|B1|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
503055|NCT00344370|P2|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
503056|NCT00344370|P1|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
503057|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
503058|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
503059|NCT00344370|O2|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
503060|NCT00344370|O1|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
503061|NCT00344370|E2|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg once daily
503062|NCT00344370|E1|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
503063|NCT00344305|B3|Baseline|Total|Total of all reporting groups
503064|NCT00344305|B2|Baseline|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503107|NCT00344175|E1|Reported Event|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503065|NCT00344305|B1|Baseline|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503066|NCT00344305|P2|Participant Flow|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503067|NCT00344305|P1|Participant Flow|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503068|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503069|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503070|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503071|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503072|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503073|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503074|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503075|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503076|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503077|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503078|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503079|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503080|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503081|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503082|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503083|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503084|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503085|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503086|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503087|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503088|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503089|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503090|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503091|NCT00344305|O2|Outcome|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503092|NCT00344305|O1|Outcome|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503093|NCT00344305|E2|Reported Event|Trivalent Influenza Virus Vaccine 24 to < 60 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503094|NCT00344305|E1|Reported Event|Trivalent Influenza Virus Vaccine 6 to < 24 Months|A single intranasal dose of 10^7 FFU trivalent influenza virus vaccine live, intranasal was administered on Day 0.
503095|NCT00344175|B3|Baseline|Total|Total of all reporting groups
503096|NCT00344175|B2|Baseline|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503097|NCT00344175|B1|Baseline|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503098|NCT00344175|P2|Participant Flow|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503099|NCT00344175|P1|Participant Flow|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503100|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503101|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503102|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503103|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503104|NCT00344175|O2|Outcome|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503105|NCT00344175|O1|Outcome|Pitavastatin 4 mg|Ptavastatin 4 mg once daily
503106|NCT00344175|E2|Reported Event|Simvastatin 40mg/80mg|Simvastatin 40 mg or 80 mg once daily
503109|NCT00344032|B2|Baseline|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503110|NCT00344032|B1|Baseline|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503111|NCT00344032|P2|Participant Flow|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503112|NCT00344032|P1|Participant Flow|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503113|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503114|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503115|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503116|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503117|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503118|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503119|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503120|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503121|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503122|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503123|NCT00344032|O2|Outcome|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503124|NCT00344032|O1|Outcome|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503125|NCT00344032|E2|Reported Event|Placebo|Subjects who received 3 doses of Placebo (at 0, 1, 6 months).
503126|NCT00344032|E1|Reported Event|Cervarix|Subjects who received 3 doses of HPV-16/18 VLP/AS04 Vaccine (Cervarix TM) (at 0, 1, 6 months).
503127|NCT00343915|B3|Baseline|Total|Total of all reporting groups
503128|NCT00343915|B2|Baseline|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503129|NCT00343915|B1|Baseline|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503130|NCT00343915|P2|Participant Flow|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503131|NCT00343915|P1|Participant Flow|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503132|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503133|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503134|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503135|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503136|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
503137|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503138|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503139|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503140|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503141|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503142|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503143|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503144|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503145|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503146|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively
503147|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503148|NCT00343915|O2|Outcome|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503149|NCT00343915|O1|Outcome|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503150|NCT00343915|O2|Outcome|3-dose Engerix|Subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503151|NCT00343915|O1|Outcome|2-dose Engerix|Subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503152|NCT00343915|E2|Reported Event|3-dose Engerix|subjects received 3 doses of paediatric (preservative-free) HBV formulation one at 0, 1 and 6 months, respectively.
503198|NCT00343564|E11|Reported Event|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
503153|NCT00343915|E1|Reported Event|2-dose Engerix|subjects received 2 doses of adult (thiomersal-free) HBV formulation, one at 0 and 6 months, respectively and placebo (physiological saline) at 1 month.
503154|NCT00343889|B3|Baseline|Total|Total of all reporting groups
503155|NCT00343889|B2|Baseline|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503156|NCT00343889|B1|Baseline|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503157|NCT00343889|P2|Participant Flow|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503158|NCT00343889|P1|Participant Flow|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503159|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503160|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503161|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503162|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503163|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503164|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503165|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503166|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503167|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503168|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503169|NCT00343889|O2|Outcome|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503170|NCT00343889|O1|Outcome|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503171|NCT00343889|E2|Reported Event|Group 2: Tritanrix-Hep B/ Hib™ + OPV|Participants received 3 doses of Tritanrix-Hep B/ Hib™ concomitantly with Oral Polio Vaccine (OPV) at 6, 10 and 14 weeks of age.
503172|NCT00343889|E1|Reported Event|Group 1: DTaP-Hep B-PRP~T + OPV|Participants received 3 doses of the DTaP-Hep B-PRP~T concomitantly with Oral Polio Vaccine (OPV), 1 dose each at 6, 10, and 14 weeks of age.
503173|NCT00343564|B12|Baseline|Total|Total of all reporting groups
503174|NCT00343564|B11|Baseline|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
503175|NCT00343564|B10|Baseline|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
503176|NCT00343564|B9|Baseline|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
503177|NCT00343564|B8|Baseline|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
503178|NCT00343564|B7|Baseline|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
503179|NCT00343564|B6|Baseline|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
503180|NCT00343564|B5|Baseline|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
503181|NCT00343564|B4|Baseline|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
503182|NCT00343564|B3|Baseline|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
503183|NCT00343564|B2|Baseline|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
503184|NCT00343564|B1|Baseline|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
503185|NCT00343564|P11|Participant Flow|10 mg/m2 With GCSF|Phase 1 dose escalation cohort 5 with GCSF support
503186|NCT00343564|P10|Participant Flow|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
503187|NCT00343564|P9|Participant Flow|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
503188|NCT00343564|P8|Participant Flow|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
503189|NCT00343564|P7|Participant Flow|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
503190|NCT00343564|P6|Participant Flow|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
503191|NCT00343564|P5|Participant Flow|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
503192|NCT00343564|P4|Participant Flow|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
503193|NCT00343564|P3|Participant Flow|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
503194|NCT00343564|P2|Participant Flow|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
503195|NCT00343564|P1|Participant Flow|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
503196|NCT00343564|O2|Outcome|Dose Escalation Cohorts 7-11 (w/ GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses with GCSF support (cohorts 7,8,9,10 and 11)
503197|NCT00343564|O1|Outcome|Dose Escalation Cohorts 1-6 (w/o GCSF)|Maximum Tolerated Dose (MTD) was determined by testing increasing doses without GCSF support (cohorts 1,2,3,4,5 and 6).
503199|NCT00343564|E10|Reported Event|9 mg/m2 With GCSF|Phase 1 dose escalation cohort 4 with GCSF support
503200|NCT00343564|E9|Reported Event|8 mg/m2 With GCSF|Phase 1 dose escalation cohort 3 with GCSF support
503201|NCT00343564|E8|Reported Event|7 mg/m2 With GCSF|Phase 1 dose escalation cohort 2 with GCSF support
503202|NCT00343564|E7|Reported Event|6 mg/m2 With GCSF|Phase 1 dose escalation cohort 1 with GCSF support
503203|NCT00343564|E6|Reported Event|7 mg/m2 Without GCSF|Phase 1 dose escalation cohort 6 without GCSF support
503204|NCT00343564|E5|Reported Event|6 mg/m2 Without GCSF|Phase 1 dose escalation cohort 5 without GCSF support
503205|NCT00343564|E4|Reported Event|5 mg/m2 Without GCSF|Phase 1 dose escalation cohort 4 without GCSF support
503206|NCT00343564|E3|Reported Event|4 mg/m2 Without GCSF|Phase 1 dose escalation cohort 3 without GCSF support
503207|NCT00343564|E2|Reported Event|3 mg/m2 Without GCSF|Phase 1 dose escalation cohort 2 without GCSF support
503208|NCT00343564|E1|Reported Event|2 mg/m2 Without GCSF|Phase 1 dose escalation cohort 1 without GCSF support
503209|NCT00343512|B1|Baseline|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
503210|NCT00343512|P1|Participant Flow|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
503211|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
503212|NCT00343512|O1|Outcome|Therapeutic Intervention|
503213|NCT00343512|O1|Outcome|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
503214|NCT00343512|E1|Reported Event|Therapeutic Intervention|Docetaxel 75 mg/m2 IV (1-hour infusion) on day 1 of each cycle (cycle = 2 weeks) x 4 cycles
503215|NCT00343460|B7|Baseline|Total|Total of all reporting groups
503216|NCT00343460|B6|Baseline|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503217|NCT00343460|B5|Baseline|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503218|NCT00343460|B4|Baseline|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503219|NCT00343460|B3|Baseline|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503220|NCT00343460|B2|Baseline|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503221|NCT00343460|B1|Baseline|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503222|NCT00343460|P3|Participant Flow|Aloxi 0.25 mg|Aloxi 0.25 mg - Safety Population
503223|NCT00343460|P2|Participant Flow|APF530 10 mg|APF530 10 mg - Safety Population
503224|NCT00343460|P1|Participant Flow|APF530 5 mg|APF530 5 mg - Safety Population
503225|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503226|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503227|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503228|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503229|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503230|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503231|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503232|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503233|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503234|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503235|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503236|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503237|NCT00343460|O4|Outcome|Cycles 1, 2, 3, and 4 - Highly|APF530 10 mg
503238|NCT00343460|O3|Outcome|Cycles 1, 2, 3 and 4 - Highly|APF530 5 mg
503239|NCT00343460|O2|Outcome|Cycles 1, 2, 3, and 4 - Moderately|APF530 10 mg
503240|NCT00343460|O1|Outcome|Cycles 1, 2, 3 and 4 - Moderately|APF530 5 mg
503241|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503242|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503243|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503244|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503245|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503246|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503247|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503248|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503249|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503250|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503251|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503252|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503253|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503254|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503255|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503256|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503257|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503258|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503259|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503260|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503261|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503262|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503263|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503264|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503265|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503266|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503267|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503268|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503269|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503270|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503271|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503272|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503273|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503274|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503275|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503276|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503277|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503278|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503279|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503280|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503281|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503282|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503283|NCT00343460|O6|Outcome|Cycle 1 Aloxi 0.25 Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503284|NCT00343460|O5|Outcome|Cycle 1 APF530 10 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503285|NCT00343460|O4|Outcome|Cycle 1 APF530 5 mg - Highly|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Highly"
503286|NCT00343460|O3|Outcome|Cycle 1 Aloxi 0.25 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503287|NCT00343460|O2|Outcome|Cycle 1 APF530 10 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503288|NCT00343460|O1|Outcome|Cycle 1 APF530 5 mg - Moderately|"Cycle 1 - Modified Intent-to-Treat Population~Emetogenic Status: Moderately"
503289|NCT00343460|E5|Reported Event|Cycle 2-4 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
503290|NCT00343460|E4|Reported Event|Cycles 2-4 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycles 2-4 - Safety Population
503291|NCT00343460|E3|Reported Event|Cycle 1 Aloxi 0.25 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
503292|NCT00343460|E2|Reported Event|Cycle 1 APF530 10 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
503293|NCT00343460|E1|Reported Event|Cycle 1 APF530 5 mg|Serious Treatment-Emergent Adverse Events - Cycle 1 - Safety Population
503294|NCT00343382|B4|Baseline|Total|Total of all reporting groups
503295|NCT00343382|B3|Baseline|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503296|NCT00343382|B2|Baseline|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503297|NCT00343382|B1|Baseline|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503298|NCT00343382|P3|Participant Flow|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503299|NCT00343382|P2|Participant Flow|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503300|NCT00343382|P1|Participant Flow|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503301|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503630|NCT00339833|P1|Participant Flow|Salsalate|The intervention was salsalate (3g/day) for 7 days
503302|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503303|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503304|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503305|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503306|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503307|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503308|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503309|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503310|NCT00343382|O3|Outcome|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503311|NCT00343382|O2|Outcome|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503312|NCT00343382|O1|Outcome|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503313|NCT00343382|E3|Reported Event|Collective Placebo|Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
503314|NCT00343382|E2|Reported Event|Pilocarpine 4 Times Per Day|Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
503315|NCT00343382|E1|Reported Event|Pilocarpine 2 Times Per Day|Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
503316|NCT00343291|B3|Baseline|Total|Total of all reporting groups
503317|NCT00343291|B2|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503318|NCT00343291|B1|Baseline|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503319|NCT00343291|P2|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503320|NCT00343291|P1|Participant Flow|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503321|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503322|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503323|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503324|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503352|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503353|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503354|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503325|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503326|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503327|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503328|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503329|NCT00343291|O2|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503330|NCT00343291|O1|Outcome|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503331|NCT00343291|E2|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/3)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Cycles 1-3:~Paclitaxel 200 mg/m² on day 1 of each 3 week cycle for the first 3 cycles~Carboplatin AUC=6 min*mg/mL on day 1 of each 3 week cycle for the first 3 cycles Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503332|NCT00343291|E1|Reported Event|Cetuximab + Bevacizumab + Paclitaxel + Carboplatin (6/6)|"Cycles 1-6:~Cetuximab 400 mg/m² initial dose on day 1 and then 250 mg/m² given every week~Bevacizumab 15 mg/kg given on day 8 of every 3 week cycle~Paclitaxel 200mg/m² on day 1 of every 3 week cycle~Carboplatin AUC=6 min*mg/mL on day 1 of every 3 week cycle~Patients who demonstrate a response or stable disease after six cycles of therapy may continue on weekly cetuximab monotherapy until disease progression, unacceptable toxicity, or another withdrawal criterion is met"
503333|NCT00343252|B3|Baseline|Total|Total of all reporting groups
503334|NCT00343252|B2|Baseline|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503335|NCT00343252|B1|Baseline|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503336|NCT00343252|P2|Participant Flow|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503337|NCT00343252|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503338|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503339|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503340|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503341|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503342|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503343|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503344|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503345|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503346|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503347|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503348|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503349|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503350|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503351|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503355|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503356|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503357|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503358|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503359|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503360|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503361|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503362|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503363|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503364|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503365|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503366|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503367|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503368|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503369|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503370|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503371|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503372|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503373|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503374|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503375|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503376|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503377|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503378|NCT00343252|O2|Outcome|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503379|NCT00343252|O1|Outcome|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503380|NCT00343252|E2|Reported Event|Risedronate|Risedronate 35 milligrams (mg)/once weekly, oral, 18 months plus daily subcutaneous injection placebo
503381|NCT00343252|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms (ug)/day, subcutaneous, 18 months plus once weekly oral placebo
503382|NCT00343083|B1|Baseline|Cetuximab (ERBITUX) and Concurrent Carboplatin|
503383|NCT00343083|P1|Participant Flow|Cetuximab (ERBITUX) and Concurrent Carboplatin|". Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy. Chemotherapy will be given every week for a total of 8 weeks. Paclitaxel will be given at a dose of 40 mg/m2 as a 1 hour infusion dose followed by cetuximab and then carboplatin AUC = 2/week.~The initial dose of cetuximab is 400 mg/m2 IV on day 1, followed by weekly infusions at 250 mg/m2 IV."
503384|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
503385|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
503386|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT
503387|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
503388|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
503389|NCT00343083|O1|Outcome|Concurrent Chemo Raditaion Wtih Cetuximab|The addition of CTX to weekly PC and daily RT.
503390|NCT00343083|E1|Reported Event|Cetuximab (ERBITUX) and Concurrent Carboplatin|
503391|NCT00343044|B1|Baseline|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503392|NCT00343044|P1|Participant Flow|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503393|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503394|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503631|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
503395|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503396|NCT00343044|O1|Outcome|Combined Weekly Topotecan and Biweekly Bevacizumab|Treatment was administered in 28 day cycles, with IV bevacizumab 10 mg/kg given on days 1 and 15 and IV topotecan 4 mg/m2 given on days 1 and 8. Treatment was continued until progressive disease defined by RECIST, symptomatic deterioration related to clinical progression, excessive toxicity. Dose reductions of bevacizumab were not permitted.
503397|NCT00343044|E1|Reported Event|Arm 1|Patients (N=40)
503398|NCT00342628|B4|Baseline|Total|Total of all reporting groups
503399|NCT00342628|B3|Baseline|DTP Vaccines|DTP at 2, 4, and 6 months of age
503400|NCT00342628|B2|Baseline|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503401|NCT00342628|B1|Baseline|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503402|NCT00342628|P3|Participant Flow|DTP Vaccines|DTP at 2, 4, and 6 months of age
503403|NCT00342628|P2|Participant Flow|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503404|NCT00342628|P1|Participant Flow|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503405|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
503406|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503407|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503408|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
503409|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503410|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503411|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
503412|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503413|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503414|NCT00342628|O3|Outcome|DTP Vaccines|DTP at 2, 4, and 6 months of age
503415|NCT00342628|O2|Outcome|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503416|NCT00342628|O1|Outcome|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503417|NCT00342628|E3|Reported Event|DTP Vaccines|DTP at 2, 4, and 6 months of age
503418|NCT00342628|E2|Reported Event|Hib-TT Plus DTP|Hib-TT plus DTP at 2,4,6 and Hib-TT at 12 months of age
503419|NCT00342628|E1|Reported Event|Vi-rEPA Plus DTP|Vi-rEPA plus DTP at 2, 4, 6 and Vi-rEPA at 12 months of age
503420|NCT00342355|B5|Baseline|Total|Total of all reporting groups
503421|NCT00342355|B4|Baseline|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
503422|NCT00342355|B3|Baseline|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
503423|NCT00342355|B2|Baseline|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
503424|NCT00342355|B1|Baseline|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
503425|NCT00342355|P4|Participant Flow|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
503426|NCT00342355|P3|Participant Flow|d4T + 3TC + EFV|Stavudine + Lamivudine + Efavirenz
503427|NCT00342355|P2|Participant Flow|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
503428|NCT00342355|P1|Participant Flow|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
503429|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
503430|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
503431|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
503432|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
503433|NCT00342355|O4|Outcome|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
503434|NCT00342355|O3|Outcome|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
503435|NCT00342355|O2|Outcome|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
503436|NCT00342355|O1|Outcome|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
503437|NCT00342355|E4|Reported Event|d4T + 3TC + r/LPV|Stavudine + Lamivudine + lopinavir/ritonavir
503438|NCT00342355|E3|Reported Event|d4T + 3TC + EFV|Stavudine + Lamivudine + efavirenz
503439|NCT00342355|E2|Reported Event|AZT + ddI + r/LPV|Zidovudine + Didanosine + Lopinavir [LPV] co-formulated with ritonavir [RTV]
503440|NCT00342355|E1|Reported Event|AZT+ddI+EFV|Zidovudine + Didanosine+Efavirenz
503441|NCT00340834|B6|Baseline|Total|Total of all reporting groups
503442|NCT00340834|B5|Baseline|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
503443|NCT00340834|B4|Baseline|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
503444|NCT00340834|B3|Baseline|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
503445|NCT00340834|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503446|NCT00340834|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503447|NCT00340834|P5|Participant Flow|Interferon β-1a/Fingolimod 0.5 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 0.5 mg capsules orally once daily.
503448|NCT00340834|P4|Participant Flow|Interferon β-1a/Fingolimod 1.25 mg|Patients who received Interferon β-1a 30 µg in the core phase of the study were randomized to receive self-administered fingolimod 1.25 mg capsules orally once daily.
503449|NCT00340834|P3|Participant Flow|Interferon β-1a 30 µg|Patients self-administered interferon β-1a 30 μg in an intramuscular (im) injection once weekly. In addition, they self-administered a fingolimod placebo capsule orally once daily.
503450|NCT00340834|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503451|NCT00340834|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503452|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503453|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503454|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503455|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503456|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503457|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503458|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503459|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503460|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503461|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503462|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503463|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503464|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503465|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503466|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503467|NCT00340834|O3|Outcome|Interferon β-1a µg/Fingolimod 1.25 or 0.5 mg|Patients received Interferon β-1a 30 µg in the core phase of the study (Baseline to Month 12) and were then randomized to receive self administered fingolimod capsules orally once daily, either 1.25 or 0.5 mg, for the remainder of the study.
503468|NCT00340834|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503469|NCT00340834|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily. In addition, they self-administered an interferon β-1a placebo intramuscular (im) injection once weekly.
503470|NCT00340834|E5|Reported Event|EXT FTY720 0.5 mg|EXT FTY720 0.5 mg
503471|NCT00340834|E4|Reported Event|EXT FTY720 1.25 mg|EXT FTY720 1.25 mg
503472|NCT00340834|E3|Reported Event|COR Interferon Beta-1a|COR Interferon beta-1a
503473|NCT00340834|E2|Reported Event|COR FTY720 0.5 mg|COR FTY720 0.5 mg
503474|NCT00340834|E1|Reported Event|COR FTY720 1.25 mg|COR FTY720 1.25 mg
503475|NCT00340704|B10|Baseline|Total|Total of all reporting groups
503476|NCT00340704|B9|Baseline|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503632|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
503633|NCT00339833|O2|Outcome|Placebo|Identical placebo for 7 days
503477|NCT00340704|B8|Baseline|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503478|NCT00340704|B7|Baseline|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503479|NCT00340704|B6|Baseline|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503480|NCT00340704|B5|Baseline|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503481|NCT00340704|B4|Baseline|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503482|NCT00340704|B3|Baseline|Tamsulosin - High Dose Level (PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503483|NCT00340704|B2|Baseline|Tamsulosin - Medium Dose Level (PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503484|NCT00340704|B1|Baseline|Tamsulosin - Low Dose Level (PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503608|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503485|NCT00340704|P9|Participant Flow|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503486|NCT00340704|P8|Participant Flow|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503487|NCT00340704|P7|Participant Flow|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503488|NCT00340704|P6|Participant Flow|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503489|NCT00340704|P5|Participant Flow|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503490|NCT00340704|P4|Participant Flow|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503491|NCT00340704|P3|Participant Flow|Tamsulosin - High Dose Level (PK Study)|"Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.~In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd,body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503492|NCT00340704|P2|Participant Flow|Tamsulosin - Medium Dose Level (PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503609|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
503493|NCT00340704|P1|Participant Flow|Tamsulosin - Low Dose Level (PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503494|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503495|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503496|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503497|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503498|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503499|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503500|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503634|NCT00339833|O1|Outcome|Salsalate|Salsalate (3g/day) for 7 days
503635|NCT00339833|E2|Reported Event|Placebo|Identical placebo for 7 days
503501|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503502|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503503|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503504|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503505|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503506|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503507|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503508|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503509|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503510|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503511|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503512|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503513|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503514|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503515|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503516|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503517|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503518|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503519|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503520|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503521|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503522|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503523|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503524|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503636|NCT00339833|E1|Reported Event|Salsalate|Salsalate (3g/day) for 7 days
503637|NCT00339183|B3|Baseline|Total|Total of all reporting groups
503525|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503526|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503527|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503528|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride,dependent on a subject's body weight.In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight.Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.One subject randomised to high dose level was not treated. Although actual number of subjects started is 11,10 were reported to ensure consistent reporting with baseline characteristics that includes only treated subjects.
503529|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Steady State - PK Study)|"Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503530|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Steady State - PK Study)|"Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy.~Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503531|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
503532|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
503610|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503611|NCT00340678|E2|Reported Event|Placebo|Subjects received placebo
503612|NCT00340678|E1|Reported Event|Losartan|Subjects received losartan
503613|NCT00340379|B3|Baseline|Total|Total of all reporting groups
503533|NCT00340704|O1|Outcome|PK Study - Single Dose|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride once daily dependent on a subject's body weight (12.1 – 25.0 kg, 25.1 – 50.0 kg and 50.1 – 100.0 kg), by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.~In PK Single dose study, it was planned to obtain the Low dose PK data after single dose from all the 30 patients randomized to Low, Medium and high. However as per the protocol amendment, the PK sampling after first drug administration of low dose level was stopped after inclusion of 11 patients and therefore the PK sample of 11 patients were evaluated for PK single dose."
503534|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503535|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503536|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503537|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503538|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503539|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503540|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503614|NCT00340379|B2|Baseline|Sertraline/Haloperidol|
503615|NCT00340379|B1|Baseline|Ziprasidone|
503616|NCT00340379|P2|Participant Flow|Sertraline/Haloperidol|Target dosage of 150-200mg/day for sertraline and 6-8mg/day for haloperidol.
503541|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503542|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503543|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503544|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503545|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503546|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503547|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503548|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503549|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503550|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503551|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503552|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503553|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503554|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503555|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503556|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503557|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503558|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503559|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503560|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503561|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503562|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503563|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503564|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503617|NCT00340379|P1|Participant Flow|Ziprasidone|Target dosage of 120-160mg/day based on tolerance.
503565|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503566|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503567|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503568|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503569|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503570|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503571|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503572|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503573|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503574|NCT00340704|O2|Outcome|Tamsulosin-medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503575|NCT00340704|O1|Outcome|Tamsulosin-low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503576|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503577|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503578|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503579|NCT00340704|O6|Outcome|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg, body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503580|NCT00340704|O5|Outcome|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|"Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy.~Subjects with body weight of 9.0-12.0 kg received medium dose of 0.025 mg qd, body weight of 12.1-25.0 kg received medium dose of 0.05 mg qd , body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503581|NCT00340704|O4|Outcome|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|"Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D- 527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy.~Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503582|NCT00340704|O3|Outcome|Tamsulosin - High Dose Level (Group D-Denovo)|"Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1-100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503583|NCT00340704|O2|Outcome|Tamsulosin - Medium Dose Level (Group D-Denovo)|"Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast."
503584|NCT00340704|O1|Outcome|Tamsulosin - Low Dose Level (Group D-Denovo)|"Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight.~In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study.~Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast."
503585|NCT00340704|E9|Reported Event|Tamsulosin - High Dose Level (Group D-527.51 Rollover)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects had to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received high dose of 0.1 mg, body weight of 25.1-50.0 kg received high dose of 0.2 mg, body weight of 50.1-100.0 kg received high dose of 0.4 mg by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503586|NCT00340704|E8|Reported Event|Tamsulosin - Medium Dose Level (Group D-527.51 Rollover)|Subjects who were to receive medium dose level (0.002-0.004 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial. All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.05 mg qd, body weight of 25.1-50.0 kg received medium dose of 0.1 mg qd, body weight of 50.1-100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503587|NCT00340704|E7|Reported Event|Tamsulosin - Low Dose Level (Group D-527.51 Rollover)|Subjects received low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-527.51 Rollover, once subjects exited the double-blind trial they were rolled over into this trial (527.66). All subjects were to titrate to their efficacious dose. Doses that were available were based on subject's weight. Depending on the LPP results, subjects could remain on that dose if it was found to be efficacious or titrate up in hopes that that the higher doses would provide some efficacy. Subjects with body weight of 12.1-25.0 kg received low dose of 0.025 mg qd, body weight of 25.1-50.0 kg received low dose of 0.05 mg qd and body weight of 50.1-100.0 kg qd received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503588|NCT00340704|E6|Reported Event|Tamsulosin - High Dose Level (Group D-Denovo)|Subjects titrated to high dose level (0.004-0.008 mg/kg) of tamsulosin hydrochloride, once daily dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0-12.0 kg received high dose of 0.05 mg qd, body weight of 12.1-25.0 kg received high dose of 0.1 mg qd, body weight of 25.1-50.0 kg received high dose of 0.2 mg qd & body weight of 50.1- 100.0 kg received high dose of 0.4 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503618|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
503619|NCT00340379|O1|Outcome|Ziprasidone|
503589|NCT00340704|E5|Reported Event|Tamsulosin - Medium Dose Level (Group D-Denovo)|Subjects who were titrated to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the Low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 9.0–12.0 kg received medium dose of 0.025 mg qd as their starting dose, body weight of 12.1-25.0 kg could have titrated to a medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg could have titrated to a medium dose of 0.1 mg qd and body weight of 50.1–100.0 kg could have titrated to a medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503590|NCT00340704|E4|Reported Event|Tamsulosin - Low Dose Level (Group D-Denovo)|Subjects received low dose level (0.001 – 0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In Group D-Denovo, all subjects started the study at the low Dose level, with the exception of the children with a body weight between 9 kg and 12 kg (they started at the Medium Dose level), and titrated up to higher dose levels on a weekly basis until an efficacious level was reached. The subjects remained on their efficacious dose level for the remainder of the study. Subjects with body weight of 12.1– 25.0 kg received low dose of 0.025 mg qd, body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503591|NCT00340704|E3|Reported Event|Tamsulosin - High Dose Level (Steady State - PK Study)|Subjects randomized to high dose level(0.004-0.008mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study,all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP,subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1-25.0kg received high dose of 0.1mg qd, body weight of 25.1-50.0kg received high dose of 0.2mg qd & body weight of 50.1-100.0kg received high dose of 0.4mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503592|NCT00340704|E2|Reported Event|Tamsulosin - Medium Dose Level (Steady State - PK Study)|Subjects randomized to medium dose level (0.002–0.004 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the LPP results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received medium dose of 0.05 mg qd, body weight of 25.1–50.0 kg received medium dose of 0.1 mg qd with and body weight of 50.1–100.0 kg received medium dose of 0.2 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt, taken 30 minutes after breakfast.
503593|NCT00340704|E1|Reported Event|Tamsulosin - Low Dose Level (Steady State - PK Study)|Subjects randomized to low dose level (0.001–0.002 mg/kg) of tamsulosin hydrochloride, dependent on a subject's body weight. In PK study, all subjects were titrated to their randomized dose level that they needed to receive which was based on their weight. Depending on the results of the Leak point pressure (LPP) results, subjects could remain on that dose if it was found to be efficacious or go back to a lower efficacious dose or titrate up in hopes that the higher dose would provide some efficacy. Subjects with body weight of 12.1–25.0 kg received low dose of 0.025 mg qd (once daily), body weight of 25.1–50.0 kg received low dose of 0.05 mg qd and body weight of 50.1–100.0 kg received low dose of 0.1 mg qd by sprinkling the content of the capsule(s) over teaspoon of apple sauce or yogurt taken 30 minutes after breakfast.
503594|NCT00340678|B5|Baseline|Total|Total of all reporting groups
503595|NCT00340678|B4|Baseline|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
503596|NCT00340678|B3|Baseline|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503597|NCT00340678|B2|Baseline|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
503598|NCT00340678|B1|Baseline|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503599|NCT00340678|P4|Participant Flow|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
503600|NCT00340678|P3|Participant Flow|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503601|NCT00340678|P2|Participant Flow|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
503602|NCT00340678|P1|Participant Flow|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503603|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
503604|NCT00340678|O3|Outcome|Microalbuminuria Losartan|Subjects with microalbuminuria were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503605|NCT00340678|O2|Outcome|Normoalbuminuria Placebo|Subjects with normal urinary albumin excretion were treated with placebo corresponding to each dose of losartan.
503606|NCT00340678|O1|Outcome|Normoalbuminuria Losartan|Subjects with normal urinary albumin excretion were treated with losartan began at 50 mg daily, with the dose increasing to 100 mg daily after 1 week if symptomatic hypotension did not develop.
503607|NCT00340678|O4|Outcome|Microalbuminuria Placebo|Subjects with Microalbuminuria were treated with placebo corresponding to each dose of losartan.
503620|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
503621|NCT00340379|O1|Outcome|Ziprasidone|
503622|NCT00340379|O2|Outcome|Sertraline/Haloperidol|
503638|NCT00339183|B2|Baseline|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503639|NCT00339183|B1|Baseline|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503640|NCT00339183|P2|Participant Flow|FOLFIRI Alone|Participants were randomized to receive a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503641|NCT00339183|P1|Participant Flow|Panitumumab Plus FOLFIRI|Participants were randomized to 6 mg/kg panitumumab intravenous infusion plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503642|NCT00339183|O2|Outcome|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503643|NCT00339183|O1|Outcome|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503644|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503645|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503646|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503647|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503648|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503649|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503650|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503651|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503652|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503653|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503654|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503655|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503656|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503657|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503658|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503659|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503660|NCT00339183|O4|Outcome|Mutant KRAS - FOLFIRI Alone|Participants with mutant KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503661|NCT00339183|O3|Outcome|Mutant KRAS - Panitumumab Plus FOLFIRI|Participants with mutant KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503662|NCT00339183|O2|Outcome|Wild-type KRAS - FOLFIRI Alone|Participants with wild-type KRAS were randomized to FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503663|NCT00339183|O1|Outcome|Wild-type KRAS - Panitumumab Plus FOLFIRI|Participants with wild-type KRAS were randomized to 6 mg/kg panitumumab plus FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503664|NCT00339183|E2|Reported Event|FOLFIRI Alone|Participants received FOLFIRI chemotherapy regimen administered in cycles every two weeks.
503665|NCT00339183|E1|Reported Event|Panitumumab Plus FOLFIRI|Participants received 6 mg/kg panitumumab IV plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment was administered in cycles every two weeks.
503666|NCT00339144|B4|Baseline|Total|Total of all reporting groups
503667|NCT00339144|B3|Baseline|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503668|NCT00339144|B2|Baseline|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503757|NCT00339040|P1|Participant Flow|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503669|NCT00339144|B1|Baseline|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503670|NCT00339144|P3|Participant Flow|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503671|NCT00339144|P2|Participant Flow|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503672|NCT00339144|P1|Participant Flow|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503673|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503674|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503675|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503676|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503677|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503678|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503679|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
503680|NCT00339144|O1|Outcome|Dasatinib (Total)|Dasatinib(100 mg, 150 mg, 200 mg) was administered once daily via oral route for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose would be escalated to next higher level. If a DLT was observed among one of three treated participants in the first course at a dose level, 3 participants would be additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose might be escalated to next higher dose level.
503758|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503834|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503681|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503682|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503683|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503684|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503685|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503686|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503687|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503688|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503689|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503690|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503691|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503692|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503693|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
512760|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
503694|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503695|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503696|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503697|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503698|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503699|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503700|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503701|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503702|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503703|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503704|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503705|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503759|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503760|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
512761|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
503706|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503707|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503708|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503709|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503710|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503711|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503712|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503713|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503714|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503715|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503716|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503717|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503761|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503762|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
512762|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
503718|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503719|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503720|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503721|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503722|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503723|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503724|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503725|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503726|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503727|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503728|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503729|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503763|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503764|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
513275|NCT00313170|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
503730|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503731|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503732|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503733|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503734|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503735|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503736|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503737|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503738|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503739|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503740|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503741|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503765|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503766|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
513277|NCT00313170|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
503742|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503743|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503744|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503745|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503746|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503747|NCT00339144|O3|Outcome|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503748|NCT00339144|O2|Outcome|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503749|NCT00339144|O1|Outcome|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503750|NCT00339144|E3|Reported Event|Dasatinib 200 mg|Participants were administered an oral dose of 200 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. Dose was not escalated above 200 mg daily.
503751|NCT00339144|E2|Reported Event|Dasatinib 150 mg|Participants were administered an oral dose of 150 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no DLT was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503752|NCT00339144|E1|Reported Event|Dasatinib 100 mg|Participants were administered an oral dose of 100 mg dasatinib tablet once daily for a period of 4 weeks. Initially, 3 participants were treated at one dose level. If no dose limiting toxicity (DLT) was observed, the dose was escalated to next higher level. If a DLT was observed among 1 of 3 treated participants in the first course at a dose level, 3 participants were additionally enrolled and treated at the same dose level. If no further DLT was observed during the first course in these additional participants, the dose was escalated to next higher dose level. Dose was not escalated above 200 mg daily.
503753|NCT00339040|B3|Baseline|Total|Total of all reporting groups
503754|NCT00339040|B2|Baseline|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503755|NCT00339040|B1|Baseline|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503756|NCT00339040|P2|Participant Flow|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503832|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503767|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503768|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503769|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503770|NCT00339040|O2|Outcome|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503771|NCT00339040|O1|Outcome|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503772|NCT00339040|E2|Reported Event|Arm B Placebo/QHPV|Participants received three doses of the placebo at week 0, 8, and 24 and additional dose of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 96, 104 and 120.
503773|NCT00339040|E1|Reported Event|Arm A QHPV|Participants received three doses of the quadrivalent human papillomavirus vaccine (QHPV) (Types 6, 11, 16, 18) at week 0, 8, and 24 and an additional dose at week 96.
503774|NCT00338988|B1|Baseline|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
503775|NCT00338988|P1|Participant Flow|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
503776|NCT00338988|O1|Outcome|Capecitabine + Oxaliplatin|Combination of intravenous (IV) oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Days 1-14.
503777|NCT00338988|E2|Reported Event|Stratum 2: No Prior Therapy|Previously untreated. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
503778|NCT00338988|E1|Reported Event|Stratum: 1 Prior Regimen|Received prior therapy. Capecitabine + Oxaliplatin: Experimental. Combination of IV oxaliplatin 100 mg/m^2 Day 1 and oral capecitabine 750 mg/m^2 twice daily on Day 1-14.
503779|NCT00338962|B5|Baseline|Total|Total of all reporting groups
503780|NCT00338962|B4|Baseline|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503781|NCT00338962|B3|Baseline|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503782|NCT00338962|B2|Baseline|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503783|NCT00338962|B1|Baseline|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503784|NCT00338962|P4|Participant Flow|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503785|NCT00338962|P3|Participant Flow|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503786|NCT00338962|P2|Participant Flow|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503787|NCT00338962|P1|Participant Flow|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503788|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503789|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503790|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503791|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503792|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503793|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503794|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503795|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503833|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503796|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503797|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503798|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503799|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503800|NCT00338962|O4|Outcome|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503801|NCT00338962|O3|Outcome|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503802|NCT00338962|O2|Outcome|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503803|NCT00338962|O1|Outcome|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503804|NCT00338962|E4|Reported Event|Desipramine and Placebo|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day.~desipramine: 200 mg per day~Placebo: placebo"
503805|NCT00338962|E3|Reported Event|Desipramine and Naltrexone|"Desipramine was started at a dose of 25 mg per day. The dose was gradually increased over 2 weeks to 200 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~desipramine: 200 mg per day~Naltrexone: 50 mg per day"
503806|NCT00338962|E2|Reported Event|Paroxetine and Placebo|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day.~paroxetine: paroxetine (40mg/day)~Placebo: placebo"
503807|NCT00338962|E1|Reported Event|Paroxetine and Naltrexone|"Paroxetine was started at 10 mg per day and the dose was gradually increased over 2 weeks to 40 mg per day. Naltrexone was started at 25 mg the first day and 50 mg per day for the rest of the treatment.~paroxetine: paroxetine (40mg/day)~Naltrexone: 50 mg per day"
503808|NCT00338884|B1|Baseline|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503809|NCT00338884|P1|Participant Flow|Sunitinib|37.5 milligrams (mg) oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503810|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503811|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503812|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503813|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503814|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503815|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503816|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503817|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503818|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503819|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503820|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503821|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503822|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503823|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503824|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503825|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503826|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503827|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503828|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503829|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503830|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503831|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
504220|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
503835|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503836|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503837|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503838|NCT00338884|O1|Outcome|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503839|NCT00338884|E1|Reported Event|Sunitinib|37.5 mg oral sunitinib malate. Dose could have been reduced to 25 mg daily due to sunitinib related toxicities.
503840|NCT00337779|B3|Baseline|Total|Total of all reporting groups
503841|NCT00337779|B2|Baseline|Glatiramer Acetate 40 mg|
503842|NCT00337779|B1|Baseline|Glatiramer Acetate 20 mg|
503843|NCT00337779|P2|Participant Flow|Glatiramer Acetate 40 mg|
503844|NCT00337779|P1|Participant Flow|Glatiramer Acetate 20 mg|
503845|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
503846|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
503847|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
503848|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
503849|NCT00337779|O2|Outcome|Glatiramer Acetate 40 mg|
503850|NCT00337779|O1|Outcome|Glatiramer Acetate 20 mg|
503851|NCT00337779|E2|Reported Event|Glatiramer Acetate 40 mg|
503852|NCT00337779|E1|Reported Event|Glatiramer Acetate 20 mg|
503853|NCT00338741|B3|Baseline|Total|Total of all reporting groups
503854|NCT00338741|B2|Baseline|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
503855|NCT00338741|B1|Baseline|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
503856|NCT00338741|P2|Participant Flow|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
503857|NCT00338741|P1|Participant Flow|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
503858|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
503859|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
503860|NCT00338741|O2|Outcome|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
503861|NCT00338741|O1|Outcome|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
503862|NCT00338741|E2|Reported Event|Non-Rebif Exposed Pregnancies|Women with MS who had not received any IFN-beta therapy during pregnancy or within 90 days of conception
503863|NCT00338741|E1|Reported Event|Rebif Exposed Pregnancies|Women with multiple sclerosis (MS) who were exposed to Rebif (interferon-beta [IFN-beta]-1a) during pregnancy or within one week of conception
503864|NCT00338455|B3|Baseline|Total|Total of all reporting groups
503865|NCT00338455|B2|Baseline|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503866|NCT00338455|B1|Baseline|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503867|NCT00338455|P2|Participant Flow|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503868|NCT00338455|P1|Participant Flow|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503869|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503870|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503871|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503872|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503873|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503874|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503875|NCT00338455|O2|Outcome|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503876|NCT00338455|O1|Outcome|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503877|NCT00338455|E2|Reported Event|Placebo + Standard Care + Dobutamine or Milrinone|Placebo - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503878|NCT00338455|E1|Reported Event|Natrecor (Nesiritide)+Standard Care+Dobutamine or Milrinone|Nesiritide - 28-day continuous infusion, no bolus; 3-hour 0.005 mcg/kg/min, may be titrated to 0.015 mcg/kg/min.
503879|NCT00338286|B3|Baseline|Total|Total of all reporting groups
503880|NCT00338286|B2|Baseline|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503881|NCT00338286|B1|Baseline|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
504234|NCT00337168|O1|Outcome|Induction|
503882|NCT00338286|P2|Participant Flow|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503883|NCT00338286|P1|Participant Flow|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503884|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503885|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503886|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503887|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503888|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503889|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503890|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503891|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503892|NCT00338286|O2|Outcome|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503893|NCT00338286|O1|Outcome|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503894|NCT00338286|E2|Reported Event|Epoetin Alfa|Participants recived SOC plus epoetin alfa 40,000 international units (IU) subcutaneously (SC) once a week.
503895|NCT00338286|E1|Reported Event|Standard of Care (SOC)|Participants received standard supportive care as packed red blood cells (RBC) transfusion as per Investigator's discretion.
503896|NCT00338104|B4|Baseline|Total|Total of all reporting groups
503897|NCT00338104|B3|Baseline|80% Group|Glargine at 80% of insulin drip rate
503898|NCT00338104|B2|Baseline|60% Group|Glargine at 60% of insulin drip rate
503899|NCT00338104|B1|Baseline|40% Group|Glargine at 40% of insulin drip rate
503900|NCT00338104|P3|Participant Flow|80% Group|Glargine at 80% of insulin drip rate
503901|NCT00338104|P2|Participant Flow|60% Group|Glargine at 60% of insulin drip rate
503902|NCT00338104|P1|Participant Flow|40% Group|Glargine at 40% of insulin drip rate
503903|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
503904|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
503905|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
503906|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
503907|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
503908|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
503909|NCT00338104|O3|Outcome|80% Group|Glargine at 80% of insulin drip rate
503910|NCT00338104|O2|Outcome|60% Group|Glargine at 60% of insulin drip rate
503911|NCT00338104|O1|Outcome|40% Group|Glargine at 40% of insulin drip rate
503912|NCT00338039|B1|Baseline|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
503913|NCT00338039|P1|Participant Flow|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 intravenous (IV)/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Grey delivered in 28 fractions.
503914|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
503915|NCT00338039|O1|Outcome|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
503949|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503950|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
504235|NCT00337168|O1|Outcome|Induction|
503916|NCT00338039|E1|Reported Event|Chemotherapy + Chemoradation|Systemic chemotherapy followed by chemoradiation in locally advanced pancreatic cancer. Cetuximab 500 mg/m^2 IV/week +/-1 day continued throughout induction chemotherapy, chemoradiation and maintenance chemotherapy. Induction Therapy Gemcitabine 1 gm/m^2 over 100 minutes every 2 weeks +/-1 day for 4 doses; Induction Chemotherapy Oxaliplatin 100 mg/m^2 over 120 minutes every 2 weeks +/-1 day for 4 doses. Capecitabine Chemoradiation (to start 2-3 weeks post completion of oxaliplatin and gemcitabine): 825 mg/m^2 by mouth (PO) twice daily Monday-Friday throughout radiation. Conformal radiation therapy to gross disease, total dose = 50.4 Gy delivered in 28 fractions.
503917|NCT00337987|B1|Baseline|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
503918|NCT00337987|P1|Participant Flow|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
503919|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
503920|NCT00337987|O1|Outcome|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
503921|NCT00337987|E1|Reported Event|Denileukin Diftitox/CHOP Administration|Patients received six 21-day cycles of therapy, up to a maximum of 8 cycle. Each cycle comprised of denileukin diftitox plus CHOP (cyclophasphamide, doxorubicin, vincristine, prednisone)
503922|NCT00337935|B3|Baseline|Total|Total of all reporting groups
503923|NCT00337935|B2|Baseline|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503924|NCT00337935|B1|Baseline|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
503925|NCT00337935|P2|Participant Flow|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503926|NCT00337935|P1|Participant Flow|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
503927|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503928|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs). Upper 95% confidence limit for the Standard of Care Group was not estimable because an insufficient number of participates reached the event at the final time point for assessment.
503929|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503930|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
503931|NCT00337935|O2|Outcome|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503932|NCT00337935|O1|Outcome|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
503933|NCT00337935|E2|Reported Event|PROCRIT (Epoetin Alfa)|epoetin alfa administered at 20,000 IU subcutaneously every 2 weeks for a period of 26 weeks
503934|NCT00337935|E1|Reported Event|Standard of Care|Standard treatment of anemia excluding use of erythropoietin stimulating agents (ESAs).
503935|NCT00337818|B4|Baseline|Total|Total of all reporting groups
503936|NCT00337818|B3|Baseline|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503937|NCT00337818|B2|Baseline|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503938|NCT00337818|B1|Baseline|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503939|NCT00337818|P3|Participant Flow|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503940|NCT00337818|P2|Participant Flow|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503941|NCT00337818|P1|Participant Flow|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503942|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503943|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503944|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503945|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503946|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503947|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503948|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
504187|NCT00337272|B1|Baseline|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
503951|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503952|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503953|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503954|NCT00337818|O3|Outcome|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503955|NCT00337818|O2|Outcome|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503956|NCT00337818|O1|Outcome|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503957|NCT00337818|E3|Reported Event|Cervarix Young|Subjects aged 10 to 14 years, who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503958|NCT00337818|E2|Reported Event|Cervarix Old Process Group|Subjects aged 15 to 25 years who received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the old manufacturing process.
503959|NCT00337818|E1|Reported Event|Cervarix New Process|Subjects aged 15 to 25 years received 3 doses (at Months 0, 1 and 6) of Cervarix™ (human papillomavirus [HPV] vaccine) produced with the new manufacturing process.
503960|NCT00337727|B3|Baseline|Total|Total of all reporting groups
503961|NCT00337727|B2|Baseline|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
503962|NCT00337727|B1|Baseline|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
503963|NCT00337727|P2|Participant Flow|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
503964|NCT00337727|P1|Participant Flow|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
503965|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
503966|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
503967|NCT00337727|O2|Outcome|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
503968|NCT00337727|O1|Outcome|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
503969|NCT00337727|E2|Reported Event|Standard Regimen|Ondansetron 8mg PO twice daily plus dexamethasone 20mg PO on Day 1 and ondansetron 8mg PO twice daily on Days 2 and 3.
503970|NCT00337727|E1|Reported Event|Aprepitant Regimen|Aprepitant 125mg by mouth (PO) plus ondansetron 8mg PO twice daily and dexamethasone 12mg PO on Day 1 and aprepitant 80mg PO once daily on Days 2 and 3.
503971|NCT00337675|B4|Baseline|Total|Total of all reporting groups
503972|NCT00337675|B3|Baseline|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503973|NCT00337675|B2|Baseline|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503974|NCT00337675|B1|Baseline|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503975|NCT00337675|P3|Participant Flow|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503976|NCT00337675|P2|Participant Flow|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503977|NCT00337675|P1|Participant Flow|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503978|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503979|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503980|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503981|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503982|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503983|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503984|NCT00337675|O3|Outcome|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503985|NCT00337675|O2|Outcome|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503986|NCT00337675|O1|Outcome|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503987|NCT00337675|E3|Reported Event|Placebo|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503988|NCT00337675|E2|Reported Event|Intermittent Montelukast|Patients were randomized to receive matching-image placebo to montelukast 4 mg (tablets or oral granules, depending on age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of montelukast 4 mg (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503989|NCT00337675|E1|Reported Event|Daily Montelukast|Patients were randomized to receive montelukast 4 mg (tablets or oral granules, depending on patient age) once daily at bedtime for 52 weeks plus intermittent 12-day courses of matching-image placebo (tablets or oral granules) once daily at bedtime (a course was initiated as needed for symptoms of imminent respiratory infection or episode of breathing problems) during the 52-week study period.
503990|NCT00337662|B4|Baseline|Total|Total of all reporting groups
503991|NCT00337662|B3|Baseline|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
503992|NCT00337662|B2|Baseline|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
503993|NCT00337662|B1|Baseline|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
503994|NCT00337662|P4|Participant Flow|Risperiodone Open-Label Lead-In|"All patients completed a 2-week open-label risperidone lead-in period. This group contains all patients who started Study Period II.~Risperidone: 2-6 mg, oral, daily"
503995|NCT00337662|P3|Participant Flow|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
503996|NCT00337662|P2|Participant Flow|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
503997|NCT00337662|P1|Participant Flow|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
503998|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
503999|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504000|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504001|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504002|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504003|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504004|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504005|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504006|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504007|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504008|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504009|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504010|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504011|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504012|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504013|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504014|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504015|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504016|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504017|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504018|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504019|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504020|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504021|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504022|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504023|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504024|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504025|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504026|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504027|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504028|NCT00337662|O3|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504029|NCT00337662|O2|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504030|NCT00337662|O1|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504031|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504032|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504033|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504034|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504035|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504036|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504037|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504038|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504039|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504040|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504041|NCT00337662|O2|Outcome|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks
504042|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504043|NCT00337662|O2|Outcome|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504044|NCT00337662|O1|Outcome|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks
504045|NCT00337662|E3|Reported Event|EO-RIS|Risperidone for early onset response (EO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
504046|NCT00337662|E2|Reported Event|NEO-RIS|Risperidone for not early onset response (NEO) patients. Risperidone: 2-6 mg, oral, daily for 10 weeks.
504047|NCT00337662|E1|Reported Event|NEO-OLZ|Olanzapine for not early onset response (NEO) patients. Olanzapine: 10-20 mg, oral, daily for 10 weeks.
504048|NCT00337610|B3|Baseline|Total|Total of all reporting groups
504049|NCT00337610|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504050|NCT00337610|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504051|NCT00337610|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504052|NCT00337610|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504053|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504054|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504055|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504056|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504057|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504058|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504059|NCT00337610|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504060|NCT00337610|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504061|NCT00337610|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504062|NCT00337610|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
504063|NCT00337571|B5|Baseline|Total|Total of all reporting groups
504064|NCT00337571|B4|Baseline|Aripiprazole 15 mg|
504065|NCT00337571|B3|Baseline|Aripiprazole 10 mg|
504066|NCT00337571|B2|Baseline|Aripiprazole 5 mg|
504067|NCT00337571|B1|Baseline|Placebo|
504068|NCT00337571|P4|Participant Flow|Aripiprazole 15 mg|
504069|NCT00337571|P3|Participant Flow|Aripiprazole 10 mg|
504070|NCT00337571|P2|Participant Flow|Aripiprazole 5 mg|
504071|NCT00337571|P1|Participant Flow|Placebo|
504072|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504073|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504074|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504075|NCT00337571|O1|Outcome|Placebo|
504076|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504077|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504078|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504079|NCT00337571|O1|Outcome|Placebo|
504080|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504081|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504082|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504083|NCT00337571|O1|Outcome|Placebo|
504084|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504085|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504086|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504087|NCT00337571|O1|Outcome|Placebo|
504088|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504089|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504090|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504091|NCT00337571|O1|Outcome|Placebo|
504092|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504093|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504094|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504095|NCT00337571|O1|Outcome|Placebo|
504096|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504097|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504098|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504099|NCT00337571|O1|Outcome|Placebo|
504100|NCT00337571|O4|Outcome|Aripiprazole 15 mg|
504101|NCT00337571|O3|Outcome|Aripiprazole 10 mg|
504102|NCT00337571|O2|Outcome|Aripiprazole 5 mg|
504103|NCT00337571|O1|Outcome|Placebo|
504104|NCT00337571|E4|Reported Event|Placebo|
504105|NCT00337571|E3|Reported Event|Aripiprazole 5 mg|
504106|NCT00337571|E2|Reported Event|Aripiprazole 15 mg|
504107|NCT00337571|E1|Reported Event|Aripiprazole 10 mg|
504108|NCT00337467|B1|Baseline|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504109|NCT00337467|P1|Participant Flow|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504110|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504111|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504112|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504113|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504114|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504115|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504116|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504117|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy.|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504118|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without virologic rebound at the end of interval
504119|NCT00337467|O1|Outcome|Proportion of Participants|Proportion of participants without treatment failure at the end of interval
504120|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504121|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504122|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504123|NCT00337467|O1|Outcome|Atazanavir (ATV)/Ritonavir (RTV) Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504124|NCT00337467|E1|Reported Event|ATV/RTV Monotherapy|ATV/RTV treatment regimen was administered once daily. ATV: 2 x 150 mg capsules once daily with food (meal or snack), RTV: 1 x 100 mg capsule once daily with food (meal or snack)
504125|NCT00337428|B3|Baseline|Total|Total of all reporting groups
504126|NCT00337428|B2|Baseline|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504127|NCT00337428|B1|Baseline|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504128|NCT00337428|P2|Participant Flow|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504129|NCT00337428|P1|Participant Flow|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504130|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504131|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504132|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504133|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504134|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504135|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504136|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504137|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504138|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504139|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504140|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504141|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504142|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504143|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504144|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504145|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504146|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504147|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504148|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504149|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504150|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504151|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504152|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504153|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504154|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504155|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504156|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504157|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504158|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504159|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504160|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504161|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504162|NCT00337428|O2|Outcome|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504163|NCT00337428|O1|Outcome|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504164|NCT00337428|E2|Reported Event|qHPV Vaccine + REPEVAX™ (Non-Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine administered on Day 1 followed by REPEVAX™ administered at Month 1.
504165|NCT00337428|E1|Reported Event|qHPV Vaccine + REPEVAX™ (Concomitant)|Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant (qHPV) vaccine and REPEVAX™ administered on Day 1 at different injection sites.
504166|NCT00337350|B3|Baseline|Total|Total of all reporting groups
504167|NCT00337350|B2|Baseline|Placebo|matched placebo for rosiglitazone 4mg/day
504168|NCT00337350|B1|Baseline|Rosiglitazone|rosiglitazone 4mg/day
504169|NCT00337350|P2|Participant Flow|Placebo|matched placebo for rosiglitazone 4mg/day
504170|NCT00337350|P1|Participant Flow|Rosiglitazone|rosiglitazone 4mg/day
504171|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
504172|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
504173|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
504174|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
504175|NCT00337350|O2|Outcome|Placebo|matched placebo for rosiglitazone 4mg/day
504176|NCT00337350|O1|Outcome|Rosiglitazone|rosiglitazone 4mg/day
504177|NCT00337350|E2|Reported Event|Placebo|matched placebo for rosiglitazone 4mg/day
504178|NCT00337350|E1|Reported Event|Rosiglitazone|rosiglitazone 4mg/day
504179|NCT00337285|B1|Baseline|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504180|NCT00337285|P1|Participant Flow|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504181|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504182|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504183|NCT00337285|O1|Outcome|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504184|NCT00337285|E1|Reported Event|Vyvanse|Subjects received a 30, 50, or 70 mg once daily dose of Vyvanse (Lisdexamfetamine dimesylate) for up to 1 year.
504185|NCT00337272|B3|Baseline|Total|Total of all reporting groups
504186|NCT00337272|B2|Baseline|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504188|NCT00337272|P2|Participant Flow|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504189|NCT00337272|P1|Participant Flow|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504190|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504191|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504192|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504193|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504194|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504195|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504196|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504197|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504198|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504199|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504200|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504201|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504202|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504203|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504204|NCT00337272|O2|Outcome|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504205|NCT00337272|O1|Outcome|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504206|NCT00337272|E2|Reported Event|2 (Ramelteon)|Patients will take 8 mgs of ramelteon 30 minutes before bedtime days 1-28 of treatment period.
504207|NCT00337272|E1|Reported Event|1 (Placebo)|Patients will take placebo 30 minutes before bedtime days 1-28 of treatment period.
504208|NCT00337207|B1|Baseline|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
504209|NCT00337207|P1|Participant Flow|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
504210|NCT00337207|O1|Outcome|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
504211|NCT00337207|E1|Reported Event|Study Treatment|All patients received bevacizumab 15 mg/kg every 3 weeks until progressive disease or unacceptable toxicity.
504212|NCT00337194|B3|Baseline|Total|Total of all reporting groups
504213|NCT00337194|B2|Baseline|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504214|NCT00337194|B1|Baseline|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504215|NCT00337194|P2|Participant Flow|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504216|NCT00337194|P1|Participant Flow|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504217|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
504218|NCT00337194|O1|Outcome|Responders|Subset of patients who achieved an overall response, as describer in primary outcome measure 1.
504219|NCT00337194|O2|Outcome|Non-responders|Subset of patients who did not achieve an overall response, as defined in primary outcome measure 1
513278|NCT00313144|B1|Baseline|Overall Study|
504221|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504222|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504223|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504224|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504225|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504226|NCT00337194|O2|Outcome|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504227|NCT00337194|O1|Outcome|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504228|NCT00337194|E2|Reported Event|Arm II (Placebo, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~placebo: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharma"
504229|NCT00337194|E1|Reported Event|Arm I (SGN-30, Chemotherapy)|"Participants receive one of the following regimens every cycle depending on history of prior stem cell transplant. Cycle is 21 days.~No prior stem cell transplant:~SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 20 mg/m^2 IV days 1 & 8, gemcitabine: 1000 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 15 mg IV days 1 & 8.~Prior stem cell transplant SGN-30: 12 mg/kg IV days 1 & 8, vinorelbine: 15 mg/m^2 IV days 1 & 8, gemcitabine: 800 mg/m^2 IV days 1 & 8, pegylated doxorubicin HCl liposome: 10 mg IV days 1 & 8.~monoclonal antibody SGN-30: Given IV~vinorelbine tartrate: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
504230|NCT00337168|B1|Baseline|Induction|
504231|NCT00337168|P1|Participant Flow|Induction|Clofarabine (40 mg per meters squared per day) and cytarabine (1 g per meters squared per day)
504232|NCT00337168|O1|Outcome|Induction|Up to two induction cycles with clofarabine and cytarabine
504233|NCT00337168|O1|Outcome|Induction|
504236|NCT00337168|E1|Reported Event|Induction|Up to two induction cycles with clofarabine and cytarabine
504237|NCT00337129|B1|Baseline|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504238|NCT00337129|P1|Participant Flow|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504239|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504240|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504241|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504242|NCT00337129|O1|Outcome|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle.
504243|NCT00337129|E1|Reported Event|Treatment (E7389 IV)|Patients receive E7389 IV on days 1 and 8 of an every 21-day cycle. Includes only patients who received drug.
504244|NCT00337103|B3|Baseline|Total|Total of all reporting groups
504245|NCT00337103|B2|Baseline|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
504246|NCT00337103|B1|Baseline|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
504247|NCT00337103|P2|Participant Flow|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
504248|NCT00337103|P1|Participant Flow|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
504249|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
504250|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
504251|NCT00337103|O2|Outcome|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
504252|NCT00337103|O1|Outcome|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
504253|NCT00337103|E2|Reported Event|Capecitabine 2.5 g/m^2/Day|Capecitabine : Capecitabine 2.5 g/m^2/day administered orally twice daily in two equal doses on Days 1 to 14 every 21 days
504254|NCT00337103|E1|Reported Event|Eribulin Mesylate 1.4 mg/m^2|Eribulin mesylate 1.4 mg/m^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days
504255|NCT00337077|B4|Baseline|Total|Total of all reporting groups
504256|NCT00337077|B3|Baseline|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504257|NCT00337077|B2|Baseline|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504258|NCT00337077|B1|Baseline|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504259|NCT00337077|P3|Participant Flow|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504260|NCT00337077|P2|Participant Flow|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504261|NCT00337077|P1|Participant Flow|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504262|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504263|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504264|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504265|NCT00337077|O3|Outcome|Two Prior Chemotherapy Regimens|Patients who received two prior chemotherapy regimens. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504266|NCT00337077|O2|Outcome|Prior Taxane|Patients who received one prior taxane regimen. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504267|NCT00337077|O1|Outcome|Chemonaive|Patients who did not receive any prior chemotherapy. Patients receive eribulin mesylate intravenously (IV) over 5 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504268|NCT00337077|E1|Reported Event|Eribulin Mesylate|All treated patients are evaluated for toxicities except for one patient who died soon after starting treatment and was not assessed for toxicity.
504269|NCT00336973|B1|Baseline|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504270|NCT00336973|P1|Participant Flow|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504575|NCT00335257|B1|Baseline|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen )
504271|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504272|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504273|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504274|NCT00336973|O1|Outcome|Efalizumab|After an initial conditioning dose of 0.7 mg/kg of subcutaneous (SC) study drug on Day 0, participants received 23 weekly doses of 1.0 mg/kg of SC study drug beginning on Day 7
504275|NCT00336895|B1|Baseline|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504276|NCT00336895|P1|Participant Flow|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504277|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504278|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504279|NCT00336895|O1|Outcome|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504280|NCT00336895|E1|Reported Event|Liver Transplant Subjects|"All subjects in this study will receive Myfortic 360mg or 720 mg BID for 90 days.~Myfortic: Myfortic 360mg or 720 mg BID for 90 days."
504281|NCT00336856|B1|Baseline|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC who received Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV), followed by 500 mg/m2 every 2 weeks IV
504282|NCT00336856|P1|Participant Flow|IRINOTECAN AND CETUXIMAB|Subjects with metastatic, CRC who have failed a first-line chemotherapeutic regimen containing oxaliplatin and a fluoropyrimidine, and who have not previously received irinotecan or cetuximab for treatment of CRC
504283|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
504284|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
504285|NCT00336856|O1|Outcome|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
504286|NCT00336856|E1|Reported Event|IRINOTECAN AND CETUXIMAB|"Cetuximab administered at an initial dose of 500 mg/m2 intravenously (IV) over 120 minutes, followed by 500 mg/m2 every 2 weeks IV over 60 minutes.~Irinotecan administered at a dose of 150 or 180 mg/m2 IV over 60 minutes every two weeks."
504287|NCT00336700|B1|Baseline|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504288|NCT00336700|P1|Participant Flow|Gemcitabine (900-1500 mg/m2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504289|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504290|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504291|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504292|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504293|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504294|NCT00336700|O1|Outcome|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|Patients with adenocarcinoma of the pancreas who adjuvant biweekly fixed-dose rate gemcitabine (1500 mg/m2) and daily erlotinib (150 mg/day) for 4 months followed by maintenance erlotinib (150 mg/day) over 8 months.
504295|NCT00336700|E1|Reported Event|Gemcitabine (900-1500 mg/m^2) + Erlotinib (50-150 mg Daily)|
504296|NCT00336583|B1|Baseline|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
504297|NCT00336583|P1|Participant Flow|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
504391|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504298|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
504299|NCT00336583|O1|Outcome|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
504300|NCT00336583|E1|Reported Event|ESHAOx|The ESHAOx consisted of Etoposide (40 mg per square meter on days 1–4), Methylprednisolone (500 mg on days 1–5), Cytarabine (2 g per square meter on day 5), and Oxaliplatin (130 mg per square meter on day 1) every 3 weeks to a maximum of six cycles.
504301|NCT00336544|B3|Baseline|Total|Total of all reporting groups
504302|NCT00336544|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504303|NCT00336544|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504304|NCT00336544|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504305|NCT00336544|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504306|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504307|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504308|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504309|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504310|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504311|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504312|NCT00336544|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504313|NCT00336544|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504314|NCT00336544|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504315|NCT00336544|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504316|NCT00336505|B3|Baseline|Total|Total of all reporting groups
504317|NCT00336505|B2|Baseline|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504318|NCT00336505|B1|Baseline|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504319|NCT00336505|P2|Participant Flow|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504320|NCT00336505|P1|Participant Flow|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504321|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504322|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504323|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504324|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504325|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504326|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504327|NCT00336505|O2|Outcome|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504328|NCT00336505|O1|Outcome|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504329|NCT00336505|E2|Reported Event|Clarithromycin|250 mg twice per day (BID) for 7 days, administered orally
504330|NCT00336505|E1|Reported Event|Cethromycin|300 mg once per day (QD) for 7 days, administered orally
504331|NCT00336492|B4|Baseline|Total|Total of all reporting groups
504332|NCT00336492|B3|Baseline|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
504333|NCT00336492|B2|Baseline|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
504334|NCT00336492|B1|Baseline|Not Randomized Group|Participants who were not randomized at Week 8
504335|NCT00336492|P3|Participant Flow|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
504336|NCT00336492|P2|Participant Flow|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
504337|NCT00336492|P1|Participant Flow|Not Randomized Group|Participants who were not randomized at Week 8
504338|NCT00336492|O2|Outcome|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
504339|NCT00336492|O1|Outcome|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
504340|NCT00336492|O1|Outcome|Infliximab 5 mg/kg|Infliximab 5 mg/kg group
504341|NCT00336492|E3|Reported Event|5 mg/kg Infliximab Every 12 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 12 wks
504342|NCT00336492|E2|Reported Event|5 mg/kg Infliximab Every 8 Wks|Participants who were clinical responders at Week 8 who were randomized to 5 mg/kg Infliximab every 8 wks
504343|NCT00336492|E1|Reported Event|Not Randomized Group|Participants who were not randomized at Week 8
504344|NCT00336479|B5|Baseline|Total|Total of all reporting groups
504345|NCT00336479|B4|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504346|NCT00336479|B3|Baseline|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504516|NCT00335452|B4|Baseline|Clopidogrel 600/150/75 mg + ASA High Dose|
504347|NCT00336479|B2|Baseline|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504348|NCT00336479|B1|Baseline|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504349|NCT00336479|P4|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504350|NCT00336479|P3|Participant Flow|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504351|NCT00336479|P2|Participant Flow|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504352|NCT00336479|P1|Participant Flow|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504353|NCT00336479|O1|Outcome|Telaprevir|All Subjects from “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week”, “Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week”, and “Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week” reporting groups who received single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks.
504354|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504355|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504356|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504357|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504358|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504359|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504360|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504361|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504362|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504363|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504517|NCT00335452|B3|Baseline|Clopidogrel 600/150/75 mg + ASA Low Dose|
504364|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504365|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504366|NCT00336479|O4|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504367|NCT00336479|O3|Outcome|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504368|NCT00336479|O2|Outcome|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504369|NCT00336479|O1|Outcome|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504370|NCT00336479|E4|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 12 weeks.
504371|NCT00336479|E3|Reported Event|Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 24 weeks.
504372|NCT00336479|E2|Reported Event|Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 48 Week|Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing <75 kg and 1200 mg/day for subjects weighing >=75 kg, for 48 weeks.
504373|NCT00336479|E1|Reported Event|PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week|Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) tablet orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (>=) 75 kg, for 48 weeks.
504374|NCT00336323|B6|Baseline|Total|Total of all reporting groups
504375|NCT00336323|B5|Baseline|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504376|NCT00336323|B4|Baseline|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504377|NCT00336323|B3|Baseline|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504378|NCT00336323|B2|Baseline|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504379|NCT00336323|B1|Baseline|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504380|NCT00336323|P5|Participant Flow|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504381|NCT00336323|P4|Participant Flow|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504382|NCT00336323|P3|Participant Flow|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504383|NCT00336323|P2|Participant Flow|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504384|NCT00336323|P1|Participant Flow|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504385|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504386|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504387|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504388|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504389|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504390|NCT00336323|O1|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504392|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504393|NCT00336323|O1|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504394|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
504395|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
504396|NCT00336323|O1|Outcome|Pooled 1.25mg Initial Bevacizumab Injection Groups|The following are the treatment groups included in the Pooled 1.25mg Bevacizumab Groups: 1.25mg at baseline and 6 weeks; and 1.25mg at baseline only
504397|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504398|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504399|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504400|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504401|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504402|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504403|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504404|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504405|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504406|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504407|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504408|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504409|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504410|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504411|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504412|NCT00336323|O1|Outcome|Pooled Bevacizumab Groups|Pooled Bevacizumab group includes the following treatment groups: 1.25mg at baseline and at 6 weeks; 2.5mg at baseline and at 6 weeks; 1.25mg at baseline only; and 1.25mg at baseline and 6 weeks plus laser at 3 weeks.
504413|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504414|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504415|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504416|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504417|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504418|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504419|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504420|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504421|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504422|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504423|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504424|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504425|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504426|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504427|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504428|NCT00336323|O5|Outcome|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504429|NCT00336323|O4|Outcome|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504430|NCT00336323|O3|Outcome|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504431|NCT00336323|O2|Outcome|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504432|NCT00336323|O1|Outcome|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504433|NCT00336323|E5|Reported Event|1.25 mg Injection at Baseline, Laser at 3w + 1.25 mg Inj at 3w|1.25 mg intravitreal injection of bevacizumab at baseline, laser photocoagulation at 3 weeks, and intravitreal injection of 1.25 mg bevacizumab at 6 weeks
504434|NCT00336323|E4|Reported Event|1.25 mg Injection at Baseline Only|1.25 mg intravitreal injection of bevacizumab at baseline (sham injection at 6 weeks)
504435|NCT00336323|E3|Reported Event|2.5 mg Injection at Baseline and 6 Weeks|2.5 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504436|NCT00336323|E2|Reported Event|1.25 mg Injection at Baseline and at 6 Weeks|1.25 mg intravitreal injection of bevacizumab at baseline and 6 weeks
504437|NCT00336323|E1|Reported Event|Laser at Baseline|Laser photocoagulation at baseline: If edema is present at 12 weeks, can be treated with 2 intravitreal injections of 1.25 mg bevacizumab spaced 6 weeks apart
504438|NCT00336284|B3|Baseline|Total|Total of all reporting groups
504439|NCT00336284|B2|Baseline|Conventional|Home Monitoring programmed OFF
504440|NCT00336284|B1|Baseline|Home Monitoring|Home Monitoring programmed ON
504441|NCT00336284|P2|Participant Flow|Conventional|Home Monitoring programmed OFF
504442|NCT00336284|P1|Participant Flow|Home Monitoring|Home Monitoring programmed ON
504443|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
504444|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
504445|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
504446|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
504447|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
504448|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
504449|NCT00336284|O2|Outcome|Conventional|Home Monitoring programmed OFF
504450|NCT00336284|O1|Outcome|Home Monitoring|Home Monitoring programmed ON
504451|NCT00336284|E2|Reported Event|Conventional|Home Monitoring programmed OFF
504452|NCT00336284|E1|Reported Event|Home Monitoring|Home Monitoring programmed ON
504453|NCT00336232|B1|Baseline|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
504454|NCT00336232|P1|Participant Flow|Vitamin K Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
504455|NCT00336232|O1|Outcome|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
504456|NCT00336232|E1|Reported Event|Diet Intervention|"5 day baseline vitamin K~Vitamin K: phylloquinone (vitamin K1) 200 mcg daily~28 day diet low vitamin K~Vitamin K: phylloquinone (vitamin K1) approx. 10 mcg daily for 28 days~treatment started day 6, completed day 33~28 day diet high vitamin K~Vitamin K: phylloquinone (vitamin K1) 500 mcg daily in third month~treatment started day 34, ended day 61"
504457|NCT00335959|B1|Baseline|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
504458|NCT00335959|P1|Participant Flow|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
504459|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation, Surgery|Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
504518|NCT00335452|B2|Baseline|Clopidogrel 300/75/75 mg + ASA High Dose|
504519|NCT00335452|B1|Baseline|Clopidogrel 300/75/75 mg + ASA Low Dose|
504460|NCT00335959|O1|Outcome|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
504461|NCT00335959|E1|Reported Event|Chemotherapy, Chemoradiation and Surgery|Patients were to receive Oxaliplatin 130 mg/m2 (2 hour IV infusion on Days 1 and 22), Capecitabine 850 mg/m2/dose (PO q 12 hours on Days 1-14 and 22-35), Capecitabine 650 mg/m2/dose (PO q 12 hours on days 43-77), Radiation therapy 180 cGy/day, 5 days/week beginning on Day 43. Patients with stable disease or better were to have distal subtotal gastrectomy, total gastrectomy, or proximal gastrectomy.
504462|NCT00335777|B1|Baseline|Migranal: All Subjects|All subjects enrolled in study
504463|NCT00335777|P1|Participant Flow|Migranal: All Subjects|All subjects enrolled in study
504464|NCT00335777|O2|Outcome|Migranal Late Treatment|Treated a headache at greater or equal to 3.5 hours after onset of throbbing
504465|NCT00335777|O1|Outcome|Migranal: Early Treatment|Treated headache within 1.25 hours of onset of throbbing
504466|NCT00335777|E1|Reported Event|Migranal: All Subjects|All subjects enrolled in study
504467|NCT00335725|B3|Baseline|Total|Total of all reporting groups
504468|NCT00335725|B2|Baseline|Gonal-f|
504469|NCT00335725|B1|Baseline|Fostimon|
504470|NCT00335725|P2|Participant Flow|Gonal-f|Recombinant FSH
504471|NCT00335725|P1|Participant Flow|Fostimon|Highly purified FSH
504472|NCT00335725|O2|Outcome|Gonal-F|
504473|NCT00335725|O1|Outcome|Fostimon|
504474|NCT00335725|O2|Outcome|Gonal-f|
504475|NCT00335725|O1|Outcome|Fostimon|
504476|NCT00335725|E2|Reported Event|Gonal-F|
504477|NCT00335725|E1|Reported Event|Fostimon|
504478|NCT00335517|B1|Baseline|Injection|DepoDur Injection
504479|NCT00335517|P1|Participant Flow|Injection|DepoDur Injection
504480|NCT00335517|O1|Outcome|Injection|DepoDur Injection
504481|NCT00335517|E1|Reported Event|Injection|DepoDur Injection
504482|NCT00335504|B5|Baseline|Total|Total of all reporting groups
504483|NCT00335504|B4|Baseline|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504484|NCT00335504|B3|Baseline|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504485|NCT00335504|B2|Baseline|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504486|NCT00335504|B1|Baseline|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504487|NCT00335504|P4|Participant Flow|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504488|NCT00335504|P3|Participant Flow|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504489|NCT00335504|P2|Participant Flow|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504490|NCT00335504|P1|Participant Flow|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504491|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504492|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504493|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504494|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504495|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504496|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504497|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504498|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504499|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504500|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504501|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504502|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504503|NCT00335504|O4|Outcome|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504504|NCT00335504|O3|Outcome|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504505|NCT00335504|O2|Outcome|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504506|NCT00335504|O1|Outcome|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504507|NCT00335504|E4|Reported Event|Arm IV (Placebo)|Patients receive an oral placebo (maltodextrin powder) twice daily.
504508|NCT00335504|E3|Reported Event|Arm III (Oligofructose-enriched Inulin)|Patients receive 6gm powder oral oligofructose-enriched inulin (Raftilose Synergy 1) twice daily.
504509|NCT00335504|E2|Reported Event|Arm II (Sulindac)|Patients receive 150 mg tablet oral sulindac twice daily.
504510|NCT00335504|E1|Reported Event|Arm I (Atorvastatin Calcium)|Patients receive 20 mg tablet oral atorvastatin once daily.
504511|NCT00335478|B1|Baseline|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
504512|NCT00335478|P1|Participant Flow|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
504513|NCT00335478|O1|Outcome|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
504514|NCT00335478|E1|Reported Event|Daptomycin|6 mg/kg over 30 minutes every 24 hours until patient is afebrile and ANC is >500 cells/mm^3.
504515|NCT00335452|B5|Baseline|Total|Total of all reporting groups
504520|NCT00335452|P4|Participant Flow|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
504521|NCT00335452|P3|Participant Flow|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
504522|NCT00335452|P2|Participant Flow|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
504523|NCT00335452|P1|Participant Flow|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
504524|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
504525|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
504526|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
504527|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
504528|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
504529|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
504530|NCT00335452|O4|Outcome|Clopidogrel 600/150/75 mg + ASA High Dose|
504531|NCT00335452|O3|Outcome|Clopidogrel 600/150/75 mg + ASA Low Dose|
504532|NCT00335452|O2|Outcome|Clopidogrel 300/75/75 mg + ASA High Dose|
504533|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA Low Dose|
504534|NCT00335452|O2|Outcome|Clopidogrel + ASA High Dose|Patients treated with ASA high dose irrespective of the Clopidogrel treatment regimen
504535|NCT00335452|O1|Outcome|Clopidogrel + ASA Low Dose|Patients treated with ASA low dose irrespective of the Clopidogrel treatment regimen
504536|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose.
504537|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
504538|NCT00335452|O2|Outcome|Clopidogrel 600/150/75 mg + ASA|Patients randomized to the Clopidogrel 600/150/75 mg dose regimen irrespective of the ASA dose
504539|NCT00335452|O1|Outcome|Clopidogrel 300/75/75 mg + ASA|Patients randomized to the Clopidogrel 300/75/75 mg dose regimen irrespective of the ASA dose
504540|NCT00335452|E4|Reported Event|Clopidogrel 600/150/75 mg + ASA High Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
504541|NCT00335452|E3|Reported Event|Clopidogrel 600/150/75 mg + ASA Low Dose|"Day 1: Clopidogrel 600 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 150 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
504542|NCT00335452|E2|Reported Event|Clopidogrel 300/75/75 mg + ASA High Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 300-325 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 300-325 mg"
504543|NCT00335452|E1|Reported Event|Clopidogrel 300/75/75 mg + ASA Low Dose|"Day 1: Clopidogrel 300 mg loading dose + ASA ≥ 300 mg~Day 2 to Day 7: Clopidogrel 75 mg + ASA 75-100 mg~Day 8 to Day 30: Clopidogrel 75 mg + ASA 75-100 mg"
504544|NCT00335322|B4|Baseline|Total|Total of all reporting groups
504545|NCT00335322|B3|Baseline|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
504546|NCT00335322|B2|Baseline|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
504547|NCT00335322|B1|Baseline|TDF/FTC+EFV|
504548|NCT00335322|P3|Participant Flow|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
504549|NCT00335322|P2|Participant Flow|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
504550|NCT00335322|P1|Participant Flow|TDF/FTC+EFV|
504551|NCT00335322|O3|Outcome|TDF/FTC+AZT+ABC|
504552|NCT00335322|O2|Outcome|TDF/FTC+r/ATV|
504553|NCT00335322|O1|Outcome|TDF/FTC+EFV|
504554|NCT00335322|E3|Reported Event|TDF/FTC+AZT+ABC|Truvada (fixed dose combination of tenofovir + emtricitabine) + zidovudine (ZDV) + abacavir (ABC)
504555|NCT00335322|E2|Reported Event|TDF/FTC+r/ATV|Truvada (fixed dose combination of tenofovir + emtricitabine)+ ritonavir/atazanavir (r/ATV)
504556|NCT00335322|E1|Reported Event|TDF/FTC+EFV|
504557|NCT00335283|B3|Baseline|Total|Total of all reporting groups
504558|NCT00335283|B2|Baseline|Placebo (Sugar Pill)|one tablet twice a day
504559|NCT00335283|B1|Baseline|Lansoprazole|40 mg twice a day
504560|NCT00335283|P2|Participant Flow|Placebo (Sugar Pill)|one tablet twice a day
504561|NCT00335283|P1|Participant Flow|Lansoprazole|40 mg twice a day
504562|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
504563|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
504564|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
504565|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
504566|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
504567|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
504568|NCT00335283|O2|Outcome|Placebo (Sugar Pill)|one tablet twice a day
504569|NCT00335283|O1|Outcome|Lansoprazole|40 mg twice a day
504570|NCT00335283|E2|Reported Event|Placebo (Sugar Pill)|one tablet twice a day
504571|NCT00335283|E1|Reported Event|Lansoprazole|40 mg twice a day
504572|NCT00335257|B4|Baseline|Total|Total of all reporting groups
504573|NCT00335257|B3|Baseline|OCs Non-DRSP|Users of OCs containing other progestins
504574|NCT00335257|B2|Baseline|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
504576|NCT00335257|P3|Participant Flow|OCs Non-DRSP|Users of OCs containing other progestins
504577|NCT00335257|P2|Participant Flow|OC DRSP-21d|OCs containing DRSP (Yasmin®, 21 day regimen)
504578|NCT00335257|P1|Participant Flow|OC DRSP-24d|OCs containing DRSP (Yaz®, 24 day regimen)
504579|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception
504580|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
504581|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins
504582|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
504583|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
504584|NCT00335257|O5|Outcome|No Use|No (hormonal) contraception at last contact
504585|NCT00335257|O4|Outcome|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or contraceptive patches)
504586|NCT00335257|O3|Outcome|OCs Non-DRSP|Users of OCs containing other progestins than DRSP
504587|NCT00335257|O2|Outcome|OC DRSP-21d|21-day regimen of DRSP/EE
504588|NCT00335257|O1|Outcome|OC DRSP-24d|24-day regimen of DRSP/EE
504589|NCT00335257|E5|Reported Event|No Use|No (hormonal) contraception)
504590|NCT00335257|E4|Reported Event|NOHC|Non-oral hormonal contraception (injections, implants, levonorgestrel-containing IUDs, or patches)
504591|NCT00335257|E3|Reported Event|OCs Non-DRSP|Users of OCs containing other progestins
504592|NCT00335257|E2|Reported Event|DRSP-21d|21-day regimen of DRSP/EE
504593|NCT00335257|E1|Reported Event|DRSP-24d|24-day regimen of DRSP/EE
504594|NCT00335153|B1|Baseline|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504595|NCT00335153|P1|Participant Flow|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive levodopa-carbidopa intestinal gel (LCIG), via the nasojejunal (NJ) tube during the NJ Test Period and delivered to the proximal small intestine via percutaneous endoscopic gastrostomy with jejunal extension tube (PEG-J) during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504596|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504597|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504598|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504599|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504600|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504709|NCT00334295|P1|Participant Flow|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504710|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
514872|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
504601|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504602|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504603|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504604|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504605|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504606|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504607|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504608|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504609|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504610|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504711|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504712|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504722|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504611|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504612|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504613|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504614|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504615|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504616|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504617|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504618|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504619|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504620|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504713|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504714|NCT00334295|O1|Outcome|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504723|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered once daily
504621|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504622|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504623|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504624|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504625|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504626|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504627|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504628|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504629|NCT00335153|O1|Outcome|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504630|NCT00335153|E1|Reported Event|Levodopa-Carbidopa Intestinal Gel (LCIG)|"All participants were to receive LCIG, via the NJ tube during the NJ Test Period and delivered to the proximal small intestine via PEG-J during the Post-PEG-J Long-Term Treatment Period. The starting dose was individually determined based on the daily dose of oral levodopa prior to study enrollment.~The infusion dose was individually optimized for each participant on the basis of response and potential adverse events. During the Post-PEG-J Long-Term Treatment Period, LCIG was expected to be infused continuously over approximately 16 hours daily with a rate of infusion ranging from 1 to 10 mL/hour (20 to 200 mg of levodopa/hour), in most instances."
504631|NCT00334958|B3|Baseline|Total|Total of all reporting groups
504715|NCT00334295|E1|Reported Event|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504716|NCT00334282|B3|Baseline|Total|Total of all reporting groups
504717|NCT00334282|B2|Baseline|Placebo|Matching Placebo administered once a day
504632|NCT00334958|B2|Baseline|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504633|NCT00334958|B1|Baseline|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504634|NCT00334958|P2|Participant Flow|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504635|NCT00334958|P1|Participant Flow|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504636|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504637|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504638|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504639|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504640|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504641|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504642|NCT00334958|O2|Outcome|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504643|NCT00334958|O1|Outcome|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504644|NCT00334958|E2|Reported Event|Placebo|For the 12-day Titration Phase, placebo was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day).
504718|NCT00334282|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504645|NCT00334958|E1|Reported Event|Rufinamide|For the 12-day Titration Phase, rufinamide was administered orally in doses starting with 400 mg twice daily and increased every 3 days in 400 mg twice daily increments up to 1600 mg twice daily (total daily dose 3200 mg). For the Maintenance Phase, maintenance doses of 1600 mg twice daily (3200 mg total daily dose) were administered. Subjects unable to tolerate the target dose (3200 mg/day) were allowed only during the Titration Phase to have the dose reduced to 3 tablets twice daily (corresponding to a dose of 2400 mg/day in the rufinamide group).
504646|NCT00334893|B3|Baseline|Total|Total of all reporting groups
504647|NCT00334893|B2|Baseline|Platinum-Sensitive Cohort|Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
504648|NCT00334893|B1|Baseline|Platinum-Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504649|NCT00334893|P2|Participant Flow|Platinum Sensitive Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504650|NCT00334893|P1|Participant Flow|Platinum Resistant Cohort|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504651|NCT00334893|O2|Outcome|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504652|NCT00334893|O1|Outcome|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504653|NCT00334893|E2|Reported Event|Platinum-Sensitive Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504654|NCT00334893|E1|Reported Event|Platinum-Resistant Disease|"Patients receive eribulin mesylate IV over 15 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~eribulin mesylate : Given IV"
504655|NCT00334815|B3|Baseline|Total|Total of all reporting groups
504656|NCT00334815|B2|Baseline|High Risk Patient Stratum|
504657|NCT00334815|B1|Baseline|Low Risk Patient Stratum|
504658|NCT00334815|P2|Participant Flow|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504659|NCT00334815|P1|Participant Flow|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504660|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504661|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504662|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504663|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504664|NCT00334815|O2|Outcome|High Risk Patient Stratum|"Patients with at least one of the following characteristics: squamous histology, a primary tumor with cavitation or within 1 cm of a major blood vessel, a history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504719|NCT00334282|P2|Participant Flow|Placebo|Matching Placebo administered orally once a day
504720|NCT00334282|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504665|NCT00334815|O1|Outcome|Low Risk Patient Stratum|"Patients with non-squamous histology, a primary tumor with no cavitation and not within 1 cm of a major blood vessel, and no history of hemoptysis.~Treatment received was cisplatin IV over 1 hour on days 1, 8, 29, and 36 and etoposide IV over 1 hour on days 1-5 and 29-33. Patients undergo concurrent thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.~cisplatin: Given IV~etoposide: Given IV~radiation therapy: Undergo thoracic radiotherapy~docetaxel: Given IV~filgrastim: Given SC~pegfilgrastim: Given SC"
504666|NCT00334815|O2|Outcome|Consolidation Therapy With Docetaxel and Bevacizumab.|
504667|NCT00334815|O1|Outcome|Concurrent Chemotherapy and Radiotherapy|
504668|NCT00334815|E2|Reported Event|Consolidation Therapy With Docetaxel and Bevacizumab|All eligible patients, both low-risk and high-risk strata combined, who received consolidation therapy with Docetaxel and Bevacizumab.
504669|NCT00334815|E1|Reported Event|Concurrent Chemotherapy and Radiotherapy|All eligible patients, both low-risk and high-risk strata combined, who received concurrent chemotherapy and radiotherapy.
504670|NCT00334802|B3|Baseline|Total|Total of all reporting groups
504671|NCT00334802|B2|Baseline|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504672|NCT00334802|B1|Baseline|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504673|NCT00334802|P2|Participant Flow|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504674|NCT00334802|P1|Participant Flow|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504675|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
504676|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
504677|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
504678|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
504679|NCT00334802|O2|Outcome|Gemcitabine|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8
504680|NCT00334802|O1|Outcome|Gemcitabine + Paclitaxcel|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 or Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 Paclitaxcel: 175 mg/m2, intravenous (IV), day 1
504681|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504682|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504683|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504684|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504685|NCT00334802|O1|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504686|NCT00334802|O2|Outcome|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504687|NCT00334802|O1|Outcome|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504688|NCT00334802|E2|Reported Event|Dose Level 2|Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504689|NCT00334802|E1|Reported Event|Dose Level 1|Gemcitabine: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles Paclitaxcel: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
504690|NCT00334633|B4|Baseline|Total|Total of all reporting groups
504691|NCT00334633|B3|Baseline|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
504692|NCT00334633|B2|Baseline|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
504693|NCT00334633|B1|Baseline|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
504694|NCT00334633|P3|Participant Flow|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
504695|NCT00334633|P2|Participant Flow|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
504696|NCT00334633|P1|Participant Flow|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
504697|NCT00334633|O3|Outcome|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
504698|NCT00334633|O2|Outcome|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
504699|NCT00334633|O1|Outcome|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
504700|NCT00334633|E3|Reported Event|Tinidazole 1 gm|tinidazole 1 gm BID for 7 days; 196 particpants
504701|NCT00334633|E2|Reported Event|Tinidazole 500 mg|tinidazole 500 BID for 7 days; 200 particpants
504702|NCT00334633|E1|Reported Event|Metronidazole|metronidazole 500 BID for 7 days; 197 participants
504703|NCT00334542|B1|Baseline|Simvastatin|Simvastatin 40 mg for 24-28 weeks
504704|NCT00334542|P1|Participant Flow|Simvastatin|Simvastatin 40 mg for 24-28 weeks
504705|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
504706|NCT00334542|O1|Outcome|Simvastatin|Simvastatin 40 mg for 24-28 weeks
504707|NCT00334542|E1|Reported Event|Simvastatin|Simvastatin 40 mg for 24-28 weeks
504708|NCT00334295|B1|Baseline|Fulvestrant|A monthly intramuscular application of 250 mg Fulvestrant as a 1st line endocrine therapy in patients with recurrent or metastatic endometrial carcinoma.
504721|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
504724|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
504725|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504726|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
504727|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504728|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
504729|NCT00334282|O1|Outcome|Pazopanib|Pazopanib 800 mg (tablets) administered orally once a day
504730|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504731|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504732|NCT00334282|O2|Outcome|Placebo|Matching placebo administered orally once a day
504733|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504734|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
504735|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504736|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered orally once a day
504737|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504738|NCT00334282|O2|Outcome|Placebo|Matching Placebo administered once a day
504739|NCT00334282|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504740|NCT00334282|E2|Reported Event|Placebo|Matching Placebo administered orally once a day
504741|NCT00334282|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
504742|NCT00334204|B1|Baseline|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504743|NCT00334204|P1|Participant Flow|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504744|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504745|NCT00334204|O1|Outcome|Measure Platelet Function Analyser-100 (PFA-100)|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504746|NCT00334204|O1|Outcome|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504747|NCT00334204|E1|Reported Event|Measure PFA-100|measuring PFA-100 test (an in vitro platelet function test, in addition to the rest of the routine/uusal clinical care)
504748|NCT00334113|B3|Baseline|Total|Total of all reporting groups
504749|NCT00334113|B2|Baseline|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
504750|NCT00334113|B1|Baseline|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
504751|NCT00334113|P2|Participant Flow|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
504752|NCT00334113|P1|Participant Flow|TLC-PED|"Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.~Motivate physical activity in diabetic individuals.: Telephone-Linked Care - Promoting Exercise for Diabetes (TLC-PED), a method that uses interactive voice response and speech recognition technologies, will be developed to provide individualized and personalized motivational messages using automated telephone calls for veterans with Type 2 diabetes who participate in a home based walking program."
504753|NCT00334113|O2|Outcome|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
504754|NCT00334113|O1|Outcome|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
504755|NCT00334113|E2|Reported Event|Treatment as Usual|"This is the treatment as usual condition. Participants in this condition will also have 2 sessions with an exercise physiologist and will receive an exercise prescription for a home based walking program. The will not receive the automated phone calls each week that are designed to motivate physical activity."
504756|NCT00334113|E1|Reported Event|TLC-PED|Participants in this arm will meet with an exercise physiologist and obtain an exercise prescription for a walking program. In addition, they will be called every week by an automated telephone system that is designed to motivate individuals with type 2 diabetes to participate in regular physical activity.
504757|NCT00334074|B1|Baseline|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
504758|NCT00334074|P1|Participant Flow|Clofarabine and Cytarabine|5 consecutive days of Clofarabine 40 mg/m^2 intravenous infusion over 1 hour followed 4 hours later by cytarabine 1000mg/m^2 intravenous infusion over 2 hours.Next cycle will start approximately 4 weeks after Day 1 of previous cycle. Patients will receive a maximum of 4 cycles of study treatment.
504759|NCT00334074|O1|Outcome|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 IV infusion 4 hours post clofarabine IVI.
504760|NCT00334074|O1|Outcome|Clofarabine Plus Cytarabine|Clofarabine 40 mg/m2 IV infusion over 1 hour for 5 days; Four hours post clofarabine infusion,Give cytarabine 1000 mg/m2 IV infusion over 2 hours.Patients will receive a maximum upto 4 cycles of study treatment.Next cycle will start approximately 4 weeks after Day 1 of previous cycle.
504761|NCT00334074|E1|Reported Event|Clofarabine and Cytarabine|Clofarabine 40 mg/m2 intravenous infusion over 1 hour for 5 days; Cytarabine 1000 mg/m2 intravenous infusion 4 hours post clofarabine IVI.
504762|NCT00334061|B1|Baseline|Penumbra System|
504763|NCT00334061|P1|Participant Flow|Penumbra System|
504764|NCT00334061|O1|Outcome|Penumbra System|
504765|NCT00334061|O1|Outcome|Penumbra System|
504766|NCT00334061|O1|Outcome|Penumbra System|
504767|NCT00334061|O1|Outcome|Penumbra System|
504768|NCT00334061|O1|Outcome|Penumbra System|
504769|NCT00334061|O1|Outcome|Penumbra System|
504770|NCT00334061|E1|Reported Event|Penumbra System|
504771|NCT00333983|B4|Baseline|Total|Total of all reporting groups
504772|NCT00333983|B3|Baseline|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
504773|NCT00333983|B2|Baseline|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes.
504774|NCT00333983|B1|Baseline|Planar Robot|Robot-assisted planar reaching x 60 minutes.
504775|NCT00333983|P3|Participant Flow|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activites, range of motion and arm ergometer x 60 minutes.
504776|NCT00333983|P2|Participant Flow|Planar + Vertical Robot|Robot-assisted planar and robot-assisted vertical reaching x 60 minutes
504777|NCT00333983|P1|Participant Flow|Planar Robot|Robot-assisted planar reaching x 60 minutes
504778|NCT00333983|O3|Outcome|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion, and arm ergometer training x 60 minutes.
504779|NCT00333983|O2|Outcome|Planar + Vertical|Planar + Vertical Robot Exercise x 60 minutes.
504780|NCT00333983|O1|Outcome|Planar Robot|Planar Robot Exercise x 60 minutes.
504781|NCT00333983|E3|Reported Event|Intensive Conventional Exercise|Upper extremity stretching, skateboard reaching activities, range of motion and arm ergometer training.
504782|NCT00333983|E2|Reported Event|Planar + Vertical Robot|Planar + Vertical Robot Exercise Group
504783|NCT00333983|E1|Reported Event|Planar Robot|Planar Robot Exercise Group
504784|NCT00333970|B3|Baseline|Total|Total of all reporting groups
504785|NCT00333970|B2|Baseline|Arm 2|treatment as usual
504786|NCT00333970|B1|Baseline|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
504787|NCT00333970|P2|Participant Flow|Arm 2|treatment as usual
504788|NCT00333970|P1|Participant Flow|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
504789|NCT00333970|O2|Outcome|Arm 2|treatment as usual
504790|NCT00333970|O1|Outcome|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
504791|NCT00333970|E2|Reported Event|Arm 2|treatment as usual
504792|NCT00333970|E1|Reported Event|Arm 1|"cognitive remediation~cognitive remediation: individual cognitive training"
504793|NCT00333879|B1|Baseline|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
504794|NCT00333879|P1|Participant Flow|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
504795|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
504796|NCT00333879|O1|Outcome|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
504797|NCT00333879|E1|Reported Event|Virtual Sound System|Efficacy of using a virtual sound system to simulate street crossing conditions.
504798|NCT00333866|B5|Baseline|Total|Total of all reporting groups
504799|NCT00333866|B4|Baseline|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504800|NCT00333866|B3|Baseline|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504801|NCT00333866|B2|Baseline|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504802|NCT00333866|B1|Baseline|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504803|NCT00333866|P4|Participant Flow|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504804|NCT00333866|P3|Participant Flow|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504805|NCT00333866|P2|Participant Flow|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504806|NCT00333866|P1|Participant Flow|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504807|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504808|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504809|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504810|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504811|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504812|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504813|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504814|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504815|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504816|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504817|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504818|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504819|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504820|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504821|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504822|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504823|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504824|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504825|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504826|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504827|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504828|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504829|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504830|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504831|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504832|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504833|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504834|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504835|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504950|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504836|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504837|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504838|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504839|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504840|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504841|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504842|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504843|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504844|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504845|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504846|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504847|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504848|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504849|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504850|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504851|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504852|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504853|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504854|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504855|NCT00333866|O4|Outcome|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504856|NCT00333866|O3|Outcome|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504857|NCT00333866|O2|Outcome|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504858|NCT00333866|O1|Outcome|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504859|NCT00333866|E4|Reported Event|Pregabalin 600 mg|Pregabalin capsule 300 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12-14: 225 mg orally twice daily and then 300 mg orally twice daily fixed dose up to Week 14.
504860|NCT00333866|E3|Reported Event|Pregabalin 450 mg|Pregabalin capsule 225 mg orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily, Day 4-8: 150 mg orally twice daily, Day 9-11: 200 mg orally twice daily and Day 12 onwards: 225 mg orally twice daily fixed dose up to Week 14.
504861|NCT00333866|E2|Reported Event|Pregabalin 300 mg|Pregabalin capsule 150 milligram (mg) orally twice daily following a 2 week titration phase, Day 1-3: 75 mg orally twice daily and Day 4 onwards: 150 mg orally twice daily fixed dose up to Week 14.
504862|NCT00333866|E1|Reported Event|Placebo|Placebo matched to pregabalin capsules orally twice daily up to Week 14.
504863|NCT00333840|B3|Baseline|Total|Total of all reporting groups
504918|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504864|NCT00333840|B2|Baseline|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504865|NCT00333840|B1|Baseline|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504866|NCT00333840|P4|Participant Flow|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
504867|NCT00333840|P3|Participant Flow|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
504868|NCT00333840|P2|Participant Flow|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504869|NCT00333840|P1|Participant Flow|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504870|NCT00333840|O1|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
504871|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504872|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504873|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
504874|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 mu/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injection for 10 days every month in the second-line treatment period.
504919|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504951|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
506429|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
504875|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504876|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504877|NCT00333840|O2|Outcome|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
504878|NCT00333840|O1|Outcome|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
504879|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504880|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504881|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504882|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
504883|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504884|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504885|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (CSI151). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504886|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504947|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504948|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
514875|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
504887|NCT00333840|O2|Outcome|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504888|NCT00333840|O1|Outcome|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C). Maximum study duration was 11.5 years.
504889|NCT00333840|E4|Reported Event|IFN-a + Ara-C to Imatinib|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571) 400 mg orally once daily in the morning.
504890|NCT00333840|E3|Reported Event|Imatinib to IFN-a + Ara-C|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month.
504891|NCT00333840|E2|Reported Event|IFN-a + Ara-C|In the first-line treatment period participants received interferon-alpha (IFN-a) subcutaneous (SC) injections escalated over 4 weeks to achieve a target dose of 5 MU/m^2/day. After the maximum tolerated dose of IFN-a was achieved, participants also received cytarabine (ARA-C) 20 mg/m^2/day (max 40 mg) SC injections for 10 days every month. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to the second-line treatment period to receive imatinib (STI571). IFN treatment was discontinued with protocol amendment 6. Maximum study duration was 8 years.
504892|NCT00333840|E1|Reported Event|Imatinib (STI571)|In the first-line treatment period participants received imatinib 400 mg orally once daily in the morning. Hydroxyurea was permitted in the first 6 months to keep the white blood cell count (WBC) below 20.0 X 10^9/liter. If protocol specific criteria applied, participants were eligible to crossover to receive interferon-alpha (IFN-a) and cytarabine (ARA-C) in the second-line treatment period. Maximum study duration was 11.5 years.
504893|NCT00333814|B4|Baseline|Total|Total of all reporting groups
504894|NCT00333814|B3|Baseline|Sham|Sham
504895|NCT00333814|B2|Baseline|Dexamethasone 700 µg|Dexamethasone 700 µg
504896|NCT00333814|B1|Baseline|Dexamethasone 350 µg|Dexamethasone 350 µg
504897|NCT00333814|P3|Participant Flow|Sham|Sham
504898|NCT00333814|P2|Participant Flow|Dexamethasone 700 µg|Dexamethasone 700 µg
504899|NCT00333814|P1|Participant Flow|Dexamethasone 350 µg|Dexamethasone 350 µg
504900|NCT00333814|O3|Outcome|Sham|Sham
504901|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
504902|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
504903|NCT00333814|O3|Outcome|Sham|Sham
504904|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
504905|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
504906|NCT00333814|O3|Outcome|Sham|Sham
504907|NCT00333814|O2|Outcome|Dexamethasone 700 µg|Dexamethasone 700 µg
504908|NCT00333814|O1|Outcome|Dexamethasone 350 µg|Dexamethasone 350 µg
504909|NCT00333814|E3|Reported Event|Sham|Sham
504910|NCT00333814|E2|Reported Event|Dexamethasone 700 µg|Dexamethasone 700 µg
504911|NCT00333814|E1|Reported Event|Dexamethasone 350 µg|Dexamethasone 350 µg
504912|NCT00333801|B3|Baseline|Total|Total of all reporting groups
504913|NCT00333801|B2|Baseline|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504914|NCT00333801|B1|Baseline|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504915|NCT00333801|P2|Participant Flow|Individual Placement and Support (IPS)|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504916|NCT00333801|P1|Participant Flow|Vocational Rehabilitation Program (VRP)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training , compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist
504917|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504949|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504920|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504921|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504922|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504923|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504924|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504925|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504926|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504927|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504928|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504929|NCT00333801|O2|Outcome|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504930|NCT00333801|O1|Outcome|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504931|NCT00333801|E2|Reported Event|Individual Placement and Support (IPS) Supported Employment|Individual Placement and Support (IPS) Supported Employment (SE) emphasizes rapid job search, community job development that is keeping with participants' preferences, placement in a competitive job, on-the-job training, time-unlimited follow-along supports, and integration of IPS specialist within the treatment team.
504932|NCT00333801|E1|Reported Event|VA Vocational Rehabilitation Program (Treatment-as-usual)|VA Vocational Rehabilitation Program (treatment-as-usual) uses traditional train-place approaches, such as prevocational work skills training, compensated work therapy, or transitional work experience, which consists of temporary employment in a brokered-job with time-limited support from the VRP specialist.
504933|NCT00333788|B1|Baseline|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504934|NCT00333788|P1|Participant Flow|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504935|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504936|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504937|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504938|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504939|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504940|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504941|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504942|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504943|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504944|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504945|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504946|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
516738|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
504952|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504953|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504954|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504955|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504956|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504957|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504958|NCT00333788|O1|Outcome|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504959|NCT00333788|E1|Reported Event|Certolizumab Pegol 400 mg|400 mg subcutaneous injection of certolizumab pegol every 2 (Q2W) or 4 (Q4W) weeks
504960|NCT00333775|B4|Baseline|Total|Total of all reporting groups
504961|NCT00333775|B3|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504962|NCT00333775|B2|Baseline|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504963|NCT00333775|B1|Baseline|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504964|NCT00333775|P3|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504965|NCT00333775|P2|Participant Flow|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504966|NCT00333775|P1|Participant Flow|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504967|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504968|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504969|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504970|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504971|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504972|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504973|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504974|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504975|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504976|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
505173|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
504977|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504978|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504979|NCT00333775|O3|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504980|NCT00333775|O2|Outcome|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504981|NCT00333775|O1|Outcome|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504982|NCT00333775|E3|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 15.0 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 15.0 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504983|NCT00333775|E2|Reported Event|Docetaxel 100 mg/m^2 Plus Bevacizumab 7.5 mg/kg|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received bevacizumab 7.5 mg/kg intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504984|NCT00333775|E1|Reported Event|Docetaxel 100 mg/m^2 Plus Placebo|Participants received docetaxel 100 mg/m^2 intravenously on Day 1 of each 3 week cycle for a maximum of 27 weeks (9 cycles). In addition, participants received placebo to bevacizumab intravenously on Day 1 of each 3 week cycle until disease progression, unacceptable toxicity, or participant withdrawal.
504985|NCT00333762|B1|Baseline|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
504986|NCT00333762|P1|Participant Flow|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
504987|NCT00333762|O1|Outcome|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
504988|NCT00333762|E1|Reported Event|Arm 1: SWCS and SPAM|"Subjects traversed a prescribed route using electric powered wheelchairs~Smart Wheelchair Component System (SWCS) :~Smart Power Assistance Module (SPAM) :"
504989|NCT00333710|B4|Baseline|Total|Total of all reporting groups
504990|NCT00333710|B3|Baseline|Control Condition/Treatment as Usual|"Control condition/treatment as usual.~No active treatment"
504991|NCT00333710|B2|Baseline|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
504992|NCT00333710|B1|Baseline|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
504993|NCT00333710|P3|Participant Flow|Control Condition/Treatment as Usual|Control condition/treatment as usual
504994|NCT00333710|P2|Participant Flow|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
504995|NCT00333710|P1|Participant Flow|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
504996|NCT00333710|O3|Outcome|Control Condition/Treatment as Usual|Control condition/treatment as usual
504997|NCT00333710|O2|Outcome|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
504998|NCT00333710|O1|Outcome|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
504999|NCT00333710|E3|Reported Event|Control Condition/Treatment as Usual|Control condition/treatment as usual
505000|NCT00333710|E2|Reported Event|Individual Telephone Contact|"Individual telephone contact treatment~Telehealth Intervention: Individual telephone contact with educational and goal setting components"
505001|NCT00333710|E1|Reported Event|Individual Face-to-face Contact|"Individual face-to-face contact treatment~Individual psychotherapy: Individual face-to-face contact with educational and goal setting components"
505002|NCT00333619|B3|Baseline|Total|Total of all reporting groups
505003|NCT00333619|B2|Baseline|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
505004|NCT00333619|B1|Baseline|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
505174|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505005|NCT00333619|P2|Participant Flow|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
505006|NCT00333619|P1|Participant Flow|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
505007|NCT00333619|O2|Outcome|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
505008|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
505009|NCT00333619|O2|Outcome|Active Control|Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).
505010|NCT00333619|O1|Outcome|Nonpharmacological Sleep Intervention|The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.
505011|NCT00333619|E2|Reported Event|Active Control|"Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions).~Active control: Daily 15-minute social visit from a research assistant. The visits include structured activities to facilitate social interaction (e.g., memory games, current event discussions)."
505012|NCT00333619|E1|Reported Event|Nonpharmacological Sleep Intervention|"The intervention will combine: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies.~Nonpharmacological sleep intervention: The intervention combines: 1) structured sleep assessment, 2) environmental interventions (efforts to increase bright light exposure, decrease daytime in-bed time, and provide a structured bedtime routine), and 3) elements of cognitive-behavioral strategies"
505013|NCT00333437|B1|Baseline|Treatment|Study subjects receive standard mycophenolate dosing.
505014|NCT00333437|P1|Participant Flow|Single-group Study Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
505015|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
505016|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
505017|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
505018|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing 2 grams/day.
505019|NCT00333437|O1|Outcome|Treatment|Study subjects receive standard mycophenolate dosing.
505020|NCT00333437|E1|Reported Event|Treatment|Study subjects receive standard mycophenolate dosing.
505021|NCT00333359|B3|Baseline|Total|Total of all reporting groups
505022|NCT00333359|B2|Baseline|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505023|NCT00333359|B1|Baseline|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505024|NCT00333359|P2|Participant Flow|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505025|NCT00333359|P1|Participant Flow|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505026|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505027|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505028|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505029|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505030|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505031|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505032|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505033|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505034|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505035|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505036|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505037|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505038|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505039|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505040|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505041|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505042|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505043|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505044|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505045|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505046|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505047|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505048|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505049|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505050|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505051|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505052|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505053|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505054|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505055|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505056|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505057|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505058|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505412|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
505059|NCT00333359|O3|Outcome|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505060|NCT00333359|O2|Outcome|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505061|NCT00333359|O1|Outcome|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505062|NCT00333359|E3|Reported Event|All Participants; 1200 mg GEn|All participants received GEn or placebo in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505063|NCT00333359|E2|Reported Event|Non-naïve; 1200 mg GEn|Non-naïve participants received GEn in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505064|NCT00333359|E1|Reported Event|Naïve; 1200 mg GEn|Naïve participants received placebo (therefore naïve to gabapentin enacarbil [GEn]) in a parent study, followed by GEn 1200 mg once a day (with the flexibility to go up to 1800 mg or down to 600 mg based on tolerability and efficacy) in this study.
505065|NCT00333229|B3|Baseline|Total|Total of all reporting groups
505066|NCT00333229|B2|Baseline|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505067|NCT00333229|B1|Baseline|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505068|NCT00333229|P2|Participant Flow|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505069|NCT00333229|P1|Participant Flow|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505070|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505071|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505072|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505073|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505074|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505075|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505076|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505077|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505078|NCT00333229|O2|Outcome|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505079|NCT00333229|O1|Outcome|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505080|NCT00333229|E2|Reported Event|Zoledronic Acid|Patients randomized into the Zometa arm received a total of 8 study drug infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505081|NCT00333229|E1|Reported Event|Placebo|Patients randomized into the Placebo Arm received a total of 8 placebo infusions which were applied every 3 months. Patients received treatment for 24 months every 3 months.
505082|NCT00333138|B4|Baseline|Total|Total of all reporting groups
505083|NCT00333138|B3|Baseline|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505084|NCT00333138|B2|Baseline|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505085|NCT00333138|B1|Baseline|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505086|NCT00333138|P3|Participant Flow|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505087|NCT00333138|P2|Participant Flow|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505088|NCT00333138|P1|Participant Flow|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505089|NCT00333138|O2|Outcome|FTY720 5.0 mg/Day|Patients randomized to fingolimod 5.0 mg/d in the core study who received fingolimod 5.0 mg/d in the dose-blind period of the extension study. All patients received fingolimod 1.25 mg/d initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
505090|NCT00333138|O1|Outcome|FTY720 1.25 mg/Day|Patients randomized to fingolimod 1.25 mg/d in the core study who received fingolimod 1.25 mg/d in the dose-blind period of the extension study and initially in the open-label period and were later converted to fingolimod 0.5 mg/d.
505091|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505092|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505093|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505094|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505095|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505096|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505097|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505098|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505099|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505100|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505101|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505102|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505103|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505104|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505105|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505106|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505128|NCT00332839|P1|Participant Flow|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505107|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505108|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505109|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505110|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505111|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505112|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505113|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505114|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505115|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505116|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505117|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505118|NCT00333138|O3|Outcome|Fingolimod (FTY720) 5.0 mg/Day|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505119|NCT00333138|O2|Outcome|Fingolimod (FTY720) 1.25 mg/Day|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505120|NCT00333138|O1|Outcome|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505121|NCT00333138|E3|Reported Event|Fingolimod (FTY720) 5.0 mg|Core study: patients received fingolimod 5.0 mg, once daily for 6 months. Extension: In dose-blind period fingolimod 5.0 mg once daily for 6-15 months. For open-label phase 1.25mg once daily for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505122|NCT00333138|E2|Reported Event|Fingolimod (FTY720) 1.25 mg|Core study: patients received fingolimod 1.25 mg, once daily for 6 months. Extension: In dose -blind period and open label, fingolimod 1.25 mg once daily for 9-18 months (6 months to 24 months). Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505123|NCT00333138|E1|Reported Event|Placebo|Core study: patients received placebo, once daily for 6 months. Extension: In dose-blind period patients were re-randomized into either fingolimod 1.25 mg or 5.0 mg once per day for 6-15 months. In open-label period patients received fingolimod 1.25 mg once per day for 15 to 24 months. Later, all patients converted to fingolimod 0.5 mg, once daily for rest of the study participation.
505124|NCT00332839|B3|Baseline|Total|Total of all reporting groups
505125|NCT00332839|B2|Baseline|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505126|NCT00332839|B1|Baseline|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505127|NCT00332839|P2|Participant Flow|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505129|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505413|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
505130|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505131|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505132|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505133|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505134|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505135|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505136|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505137|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505138|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505139|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505140|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505141|NCT00332839|O2|Outcome|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505142|NCT00332839|O1|Outcome|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505143|NCT00332839|E2|Reported Event|Certican Group|Participants were switched in a step-wise fashion from the CNI based regimen to Everolimus (RAD001).
505144|NCT00332839|E1|Reported Event|Calcineurin Inhibitor (CNI) Group|Participants received Cyclosporine A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids, or Tacrolimus A (CsA) plus Enteric Coated Mycophenolate Sodium (EC-MPS) plus corticosteroids.
505145|NCT00332722|B3|Baseline|Total|Total of all reporting groups
505146|NCT00332722|B2|Baseline|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
505147|NCT00332722|B1|Baseline|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
505148|NCT00332722|P2|Participant Flow|Group 2 With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
505149|NCT00332722|P1|Participant Flow|Group 1 Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
505150|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
505151|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
505152|NCT00332722|O2|Outcome|Group 2 - With Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
505153|NCT00332722|O1|Outcome|Group 1 - Without Steroids|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
505154|NCT00332722|E2|Reported Event|Group 2 - With Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin) and 0.15 mg of non-particulate betamethasone)
505155|NCT00332722|E1|Reported Event|Group 1- Without Steroid|Cervical Facet Joint nerve block with Local Anesthetic (0.5 mL of 0.25% Bupivacaine with/without 0.5 mL of Sarapin)
505156|NCT00332709|B3|Baseline|Total|Total of all reporting groups
505157|NCT00332709|B2|Baseline|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505158|NCT00332709|B1|Baseline|Letrozole|Letrozole 2.5 mg/day for 3 years
505159|NCT00332709|P2|Participant Flow|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505160|NCT00332709|P1|Participant Flow|Letrozole|Letrozole 2.5 mg/day for 3 years
505161|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505162|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505163|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505164|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505165|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505166|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505167|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505168|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505169|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505170|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505171|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505175|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505176|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505177|NCT00332709|O2|Outcome|Letrozole + Zoledronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505178|NCT00332709|O1|Outcome|Letrozole|Letrozole 2.5 mg/day for 3 years
505179|NCT00332709|E2|Reported Event|Letrozole + Zolendronic Acid|Letrozole 2.5mg/day for 3 years plus Zoledronic acid 4mg every 6 months
505180|NCT00332709|E1|Reported Event|Letrozole|Letrozole orally 2.5 mg/day for 3 years
505181|NCT00332696|B3|Baseline|Total|Total of all reporting groups
505182|NCT00332696|B2|Baseline|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505183|NCT00332696|B1|Baseline|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505184|NCT00332696|P2|Participant Flow|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505185|NCT00332696|P1|Participant Flow|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505186|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505187|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505188|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505189|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505190|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505191|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505192|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505193|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505194|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505195|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505414|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
505196|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505197|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505198|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505199|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505200|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505201|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505202|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505203|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505204|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505205|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505206|NCT00332696|O2|Outcome|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505207|NCT00332696|O1|Outcome|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505208|NCT00332696|E2|Reported Event|Placebo|Participants received physiologic saline solution intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received physiologic saline solution (administered subcutaneously 2 or 3 times a day or via continuous intravenous or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505209|NCT00332696|E1|Reported Event|Octreotide|Participants received Octreotide long-acting release (LAR) 30 mg intramuscular injection every 28 days for 3 months beginning on Day 1. Participants also received immediate-release Octreotide 600 µg/day (administered subcutaneously 2 or 3 times a day or via continuous intravenous (IV) or subcutaneous injection over a 24 hour period) and methlylpredinisolone 3-4 mg/kg per day (IV bolus for 1 hour or 2 subcutaneous injections) for the first 6 days.
505210|NCT00332644|B7|Baseline|Total|Total of all reporting groups
505211|NCT00332644|B6|Baseline|Placebo Control|placebo control (no active medication) treatment
505212|NCT00332644|B5|Baseline|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
505213|NCT00332644|B4|Baseline|Bupropion|bupropion alone treatment
505214|NCT00332644|B3|Baseline|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
505215|NCT00332644|B2|Baseline|Nicotine Lozenge|nicotine lozenge alone treatment
505216|NCT00332644|B1|Baseline|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
505217|NCT00332644|P6|Participant Flow|Placebo Control|placebo control (no active medication) treatment
505218|NCT00332644|P5|Participant Flow|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
505219|NCT00332644|P4|Participant Flow|Bupropion|bupropion alone treatment
505220|NCT00332644|P3|Participant Flow|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
505221|NCT00332644|P2|Participant Flow|Nicotine Lozenge|nicotine lozenge alone treatment
505222|NCT00332644|P1|Participant Flow|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
505223|NCT00332644|O6|Outcome|Placebo Control|placebo control (no active medication) treatment
505224|NCT00332644|O5|Outcome|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
505225|NCT00332644|O4|Outcome|Bupropion|bupropion alone treatment
505226|NCT00332644|O3|Outcome|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
505227|NCT00332644|O2|Outcome|Nicotine Lozenge|nicotine lozenge alone treatment
505228|NCT00332644|O1|Outcome|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
505229|NCT00332644|E6|Reported Event|Placebo Control|placebo control (no active medication) treatment
505230|NCT00332644|E5|Reported Event|Bupropion + Nicotine Lozenge|bupropion + nicotine lozenge combination treatment
505231|NCT00332644|E4|Reported Event|Bupropion|bupropion alone treatment
505232|NCT00332644|E3|Reported Event|Nicotine Patch + Lozenge|nicotine patch + lozenge combination treatment
505233|NCT00332644|E2|Reported Event|Nicotine Lozenge|nicotine lozenge alone treatment
505234|NCT00332644|E1|Reported Event|Nicotine Patch|nicotine patch alone treatment for nicotine dependence.
505235|NCT00332605|B4|Baseline|Total|Total of all reporting groups
505236|NCT00332605|B3|Baseline|Placebo|
505237|NCT00332605|B2|Baseline|N-Acetyl Cysteine|600mg tablets taken by mouth daily
505238|NCT00332605|B1|Baseline|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
505239|NCT00332605|P3|Participant Flow|Placebo|
505240|NCT00332605|P2|Participant Flow|N-Acetyl Cysteine|600mg tablets taken by mouth daily
505241|NCT00332605|P1|Participant Flow|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
505242|NCT00332605|O3|Outcome|Placebo|Placebo capsules
505243|NCT00332605|O2|Outcome|N-Acetyl Cysteine|600mg tablets, daily
505244|NCT00332605|O1|Outcome|Naltrexone|Naltrexone tablets
505245|NCT00332605|E3|Reported Event|Placebo|
505246|NCT00332605|E2|Reported Event|N-Acetyl Cysteine|600mg tablets taken by mouth daily
505247|NCT00332605|E1|Reported Event|Naltrexone|Naltrexone tablets - 50mg pills taken by mouth daily
505248|NCT00332579|B3|Baseline|Total|Total of all reporting groups
505249|NCT00332579|B2|Baseline|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
505250|NCT00332579|B1|Baseline|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
505251|NCT00332579|P2|Participant Flow|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
505252|NCT00332579|P1|Participant Flow|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
505253|NCT00332579|O2|Outcome|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
505254|NCT00332579|O1|Outcome|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
505255|NCT00332579|E2|Reported Event|Placebo|Placebo tablets (identical to naltrexone pills) taken by mouth daily.
505256|NCT00332579|E1|Reported Event|Naltrexone|Naltrexone 50mg tablets taken daily. Dose range from 50mg-150mg by mouth daily. Started at 50mg and then titrated up based upon investigator discretion.
505257|NCT00332488|B4|Baseline|Total|Total of all reporting groups
505258|NCT00332488|B3|Baseline|TI Inhalation Powder + Metformin|
505259|NCT00332488|B2|Baseline|Metformin & Secretagogues|
505260|NCT00332488|B1|Baseline|TI Inhalation Powder Alone|
505261|NCT00332488|P3|Participant Flow|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder administered prior to each meal (dose individualized for each subject) & Metformin (>= 1,000 mg/day or maximum tolerate dose)
505262|NCT00332488|P2|Participant Flow|Metformin & Secretagogues|Metformin (>= 1,000 mg/day or maximum tolerate dose) & Secretagogue (Sulfonylurea or meglitinide at >= half maximum manufacturer recommended dose or maximum tolerated dose)
505263|NCT00332488|P1|Participant Flow|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder administered prior to each meal without any other anti-diabetic treatment; dose individualized for each subject
505264|NCT00332488|O3|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
505265|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
505266|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
505267|NCT00332488|O2|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
505268|NCT00332488|O1|Outcome|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
505269|NCT00332488|O2|Outcome|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
505270|NCT00332488|O1|Outcome|Metformin & Secretagogues|Metformin & Secretagogues
505271|NCT00332488|E3|Reported Event|TI Inhalation Powder + Metformin|Technosphere® Insulin Inhalation Powder & Metformin
505272|NCT00332488|E2|Reported Event|Metformin & Secretagogues|Metformin & Secretagogues
505273|NCT00332488|E1|Reported Event|TI Inhalation Powder Alone|Technosphere® Insulin Inhalation Powder
505274|NCT00332462|B1|Baseline|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
505415|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
505416|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
505275|NCT00332462|P1|Participant Flow|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
505276|NCT00332462|O2|Outcome|6 Months After Transplantation|
505277|NCT00332462|O1|Outcome|3 Months After Transplantation|
505278|NCT00332462|O1|Outcome|Cyclosporine (Sandimmun®)|Period 1: Cyclosporine (Sandimmun® i.v.) intravenous given 2 times daily as an infusion over four hours staring at a dose of 2 X 200 mg/day for 7 days followed by Period 2: Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
505279|NCT00332462|E2|Reported Event|Cyclosporine (Sandimmun® Optoral)|Sandimmun® Optoral microemulsion oral capsule twice daily starting at an initial daily dose of 8-12 mg/kg/day. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
505280|NCT00332462|E1|Reported Event|Cyclosporine (Sandimmun® i.v.)|Cyclosporine (Sandimmun®) intravenous (i.v) given 2 times daily as an infusion over a four hour period staring at a dose of 2 X 200 mg/day and continuing for 7 days. Dosages were adjusted based on blood levels at two hours to achieve protocol specified target levels.
505281|NCT00330759|B3|Baseline|Total|Total of all reporting groups
505282|NCT00330759|B2|Baseline|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
505283|NCT00330759|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
505284|NCT00330759|P2|Participant Flow|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
505285|NCT00330759|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
505286|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
505287|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
505288|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
505289|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
505290|NCT00330759|O2|Outcome|Denosumab|Denosumab 120 mg by subcutaneous injection with an intravenous zoledronic acid placebo once every 4 weeks
505291|NCT00330759|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
505292|NCT00330759|E2|Reported Event|Denosumab 120 mg Q4W|
505293|NCT00330759|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
505294|NCT00330733|B3|Baseline|Total|Total of all reporting groups
505295|NCT00330733|B2|Baseline|Arm 2|"Salsalate~Salsalate: Salsalate therapy, double-masked"
505296|NCT00330733|B1|Baseline|Arm 1|"Matching placebo~Placebo: Matching placebo"
505297|NCT00330733|P2|Participant Flow|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
505298|NCT00330733|P1|Participant Flow|Arm 1|"Matching placebo~Placebo: Matching placebo~Seventy-eight individuals entered the placebo run-in phase. Of these, 71 were randomised and 70 returned to receive study medication"
505299|NCT00330733|O2|Outcome|Arm 2|"Salsalate~Salsalate: Salsalate therapy"
505300|NCT00330733|O1|Outcome|Arm 1|"Matching placebo~Placebo: Matching placebo"
505301|NCT00330733|E2|Reported Event|Arm 2|"Salsalate~Salsalate: Salsalate therapy The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
505302|NCT00330733|E1|Reported Event|Arm 1|"Matching placebo~Placebo: Matching placebo The frequency of tinnitus was relatively low (n=4 for salsalate, n= 2 for placebo), only one instance was graded > mild. Gastrointestinal complaints did not differ between groups (n= 8 for salsalate, n=5 for placebo). No hypoglycaemia occurred."
505303|NCT00330668|B1|Baseline|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505304|NCT00330668|P1|Participant Flow|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505305|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505306|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505307|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505308|NCT00330668|O1|Outcome|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505309|NCT00330668|E1|Reported Event|rhIGF-1 Injection|All patients entering study began rhIGF-1 twice daily treatment (range from 40 ug/kg to 120 ug/kg). Following protocol Amendment 2, all patients first received 160 ug/kg once daily followed by individual dose-escalation to 240 ug/kg once daily.
505310|NCT00330616|B1|Baseline|Bupropion SR|
505417|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
505418|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
505419|NCT00330460|E2|Reported Event|Denosumab 60 mg Q6M|
505311|NCT00330616|P1|Participant Flow|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
505312|NCT00330616|O1|Outcome|Bupropion SR|
505313|NCT00330616|O1|Outcome|Bupropion SR|
505314|NCT00330616|O1|Outcome|Bupropion SR|
505315|NCT00330616|O1|Outcome|Bupropion SR|
505316|NCT00330616|O1|Outcome|Bupropion SR|
505317|NCT00330616|O1|Outcome|Bupropion SR|
505318|NCT00330616|O1|Outcome|Bupropion SR|
505319|NCT00330616|O1|Outcome|Bupropion SR|
505320|NCT00330616|O1|Outcome|Bupropion SR|
505321|NCT00330616|O1|Outcome|Bupropion SR|
505322|NCT00330616|O1|Outcome|Bupropion SR|
505323|NCT00330616|O1|Outcome|Bupropion SR|
505324|NCT00330616|O1|Outcome|Bupropion SR|
505325|NCT00330616|O1|Outcome|Bupropion SR|
505326|NCT00330616|O1|Outcome|Bupropion SR|
505327|NCT00330616|O1|Outcome|Bupropion SR|
505328|NCT00330616|E1|Reported Event|Bupropion SR|Dose level 1 = 100mg tablet of Bupropion SR morning, after one week dose 1, increased to Dose 2 twice daily 100mg of Bupropion SR morning and evening, after one week at dose 2 could increase to Dose 3 150mg Bupropion twice daily morning and evening. Subjects stayed at dose level 3 for 6 weeks if tolerated.
505329|NCT00330564|B1|Baseline|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
505330|NCT00330564|P1|Participant Flow|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
505331|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
505332|NCT00330564|O1|Outcome|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
505333|NCT00330564|E1|Reported Event|SU011248 (Sutent, Sunitinib Malate)|50 mg/day orally for 4 weeks
505334|NCT00332332|B1|Baseline|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505335|NCT00332332|P1|Participant Flow|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505336|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505337|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505338|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505339|NCT00332332|O1|Outcome|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505340|NCT00332332|E1|Reported Event|Etanercept|Open label etanercept administered subcutaneously at 50 mg twice weekly for 3 months, followed by a maintenance dose of 50 mg once weekly for the remaining 9 months of the study.
505341|NCT00332241|B3|Baseline|Total|Total of all reporting groups
505342|NCT00332241|B2|Baseline|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505343|NCT00332241|B1|Baseline|Placebo|oral placebo once daily (QD)
505344|NCT00332241|P2|Participant Flow|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505345|NCT00332241|P1|Participant Flow|Placebo|oral placebo once daily (QD)
505346|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505347|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505348|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505349|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505350|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505351|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505352|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505353|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505354|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505355|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505356|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505357|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505358|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505359|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505360|NCT00332241|O2|Outcome|Aripiprazole|oral aripiprazole 2 to 15 mg QD
505361|NCT00332241|O1|Outcome|Placebo|oral placebo once daily (QD)
505362|NCT00332241|E2|Reported Event|Placebo|
505363|NCT00332241|E1|Reported Event|Aripiprazole|
505364|NCT00332189|B1|Baseline|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
505365|NCT00332189|P1|Participant Flow|Total Patient Population|Phenoptin will be taken orally once daily as the number of tablets equivalent to that of the last prescribed dose of the previous study (PKU-004 NCT00225615 or PKU-006 NCT00272792). Subjects who participated in PKU-006 NCT00272792 will receive Phenoptin as the number of tablets equivalent to 20 mg/kg/day at enrollment. The Phenoptin dose may be adjusted up or down as needed at the discretion of the investigator in increments of approximately 5 mg/kg/day within a range of 5 mg/kg/day to 20 mg/kg/day to control blood Phe to levels consistent with local clinical site recommendations for blood Phe control.
505366|NCT00332189|O1|Outcome|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
505367|NCT00332189|O1|Outcome|Total Patient Population|The safety analysis population includes all subjects who received at least one dose of study drug during the study.
505368|NCT00332189|E1|Reported Event|Total Patient Population|The mean (+/- SD) daily dose of study drug was 16.4 (+/-4.4) mg/kg. The final dose prescribed was 20 mg/kg/day for 73 (65.8%) subjects, 10 mg/kg/day for 33 (29.7%) subjects, and 5 mg/kg/day for 5 (4.5%) subjects.
505369|NCT00332163|B3|Baseline|Total|Total of all reporting groups
505370|NCT00332163|B2|Baseline|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505371|NCT00332163|B1|Baseline|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505372|NCT00332163|P2|Participant Flow|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505373|NCT00332163|P1|Participant Flow|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505374|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505375|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505376|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505377|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505378|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505379|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505380|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505381|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505382|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505383|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505384|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505385|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505386|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505420|NCT00330460|E1|Reported Event|Alendronate 70 mg QW|
505444|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505387|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505388|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505389|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505390|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505391|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505392|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505393|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505394|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505395|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505396|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505397|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505398|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505399|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505400|NCT00332163|O2|Outcome|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505401|NCT00332163|O1|Outcome|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505402|NCT00332163|E2|Reported Event|Reactive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg Q2W or irinotecan and panitumumab 9 mg/kg Q3W. Participants were treated for each individual skin toxicity occurrence according to prespecified guidelines and based on the type and severity. Treatment could include emollient, sunscreen, topical or oral steroids, antibiotics, or antihistamines, as required.
505403|NCT00332163|E1|Reported Event|Pre-emptive Skin Treatment|Participants received either FOLFIRI and panitumumab 6 mg/kg once every 2 weeks (Q2W) or irinotecan and panitumumab 9 mg/kg once every 3 weeks (Q3W), and pre-emptive skin treatment which included skin moisturizer, sunscreen, 1% hydrocortisone cream, and an oral antibiotic for 6 weeks starting 24 hours prior to chemotherapy.
505404|NCT00330460|B3|Baseline|Total|Total of all reporting groups
505405|NCT00330460|B2|Baseline|Denosumab 60 mg Q6M|
505406|NCT00330460|B1|Baseline|Alendronate 70 mg QW|
505407|NCT00330460|P2|Participant Flow|Denosumab 60 mg Q6M|
505408|NCT00330460|P1|Participant Flow|Alendronate 70 mg QW|
505409|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
505410|NCT00330460|O1|Outcome|Alendronate 70 mg QW|
505411|NCT00330460|O2|Outcome|Denosumab 60 mg Q6M|
505421|NCT00330421|B1|Baseline|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
505422|NCT00330421|P2|Participant Flow|Group I (Sarcomas of Extremity)|Patients receive oral sorafenib twice daily on days 1-14. Patients undergo surgical resection of the tumor on approximately day 15. Once patients recover from surgery (and radiotherapy if indicated), patients who demonstrate a clinically and pathologically significant response (≥ 25% reduction in tumor size or ≥ 25% necrosis in the surgical specimen) may continue sorafenib as above for a maximum of 6 months in the absence of disease progression or unacceptable toxicity and at the discretion of the principal investigator. Biopsy tissue and blood samples are examined for biomarkers and interstitial fluid pressure (IFP) is measured at baseline and immediately before surgery.
505423|NCT00330421|P1|Participant Flow|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
505424|NCT00330421|O1|Outcome|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
505425|NCT00330421|E1|Reported Event|Group II (Metastatic or Inoperable Sarcomas)|"Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days for 2 courses. Patients with responding or stable disease may continue sorafenib in the absence of disease progression or unacceptable toxicity. Biopsy tissue and blood samples are examined for biomarkers and IFP is measured at baseline and on days 28 and 56.~laboratory biomarker analysis : Correlative studies~sorafenib tosylate : Given PO~pharmacological study : Correlative studies~computed tomography : Correlative studies~dynamic contrast-enhanced magnetic resonance imaging : Correlative studies"
505426|NCT00330382|B3|Baseline|Total|Total of all reporting groups
505427|NCT00330382|B2|Baseline|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505428|NCT00330382|B1|Baseline|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505429|NCT00330382|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505430|NCT00330382|P1|Participant Flow|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505431|NCT00330382|O1|Outcome|Combined Bowman-Birk Inhibitor Concentrate and Placebo Groups|"Patients receive oral Bowman-Birk inhibitor concentrate or Placebo twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally Placebo: Given orally laboratory biomarker analysis: Correlative studies"
505432|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505433|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505434|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505435|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505436|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505437|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505438|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505439|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505440|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505441|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505442|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505443|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505533|NCT00330928|P1|Participant Flow|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
505445|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505446|NCT00330382|O2|Outcome|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505447|NCT00330382|O1|Outcome|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505448|NCT00330382|E2|Reported Event|Arm II (Placebo)|"Patients receive oral placebo twice daily for 6 months~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
505449|NCT00330382|E1|Reported Event|Arm I (Bowman-Birk Inhibitor Concentrate)|"Patients receive oral Bowman-Birk inhibitor concentrate twice daily for 6 months~Bowman-Birk inhibitor concentrate: Given orally~laboratory biomarker analysis: Correlative studies"
505450|NCT00331864|B3|Baseline|Total|Total of all reporting groups
505451|NCT00331864|B2|Baseline|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505452|NCT00331864|B1|Baseline|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505453|NCT00331864|P2|Participant Flow|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505454|NCT00331864|P1|Participant Flow|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505455|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505456|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505457|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505458|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505459|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505460|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505461|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505462|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505463|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505464|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505465|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505466|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505467|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505468|NCT00331864|O2|Outcome|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505469|NCT00331864|O1|Outcome|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505470|NCT00331864|E2|Reported Event|Ranibizumab ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). From Month 0 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab was injected if the patient met retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505471|NCT00331864|E1|Reported Event|Ranibizumab Non-ANCHOR|Patients received up to 12 intravitreal injections (Month 0 through Month 11). The dose of 0.3 mg ranibizumab was administered monthly for three consecutive months. From Month 3 through Month 11, either 0.3 mg ranibizumab or, after implementation of an amendment to the protocol, 0.5 mg ranibizumab were injected as individually needed based on retreatment criteria described in the protocol. Ranibizumab was administered no sooner than 14 days after the previous treatment.
505472|NCT00331799|B1|Baseline|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
505473|NCT00331799|P1|Participant Flow|Open Label Treatment With Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg / day .
505474|NCT00331799|O1|Outcome|Duloxetine|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
505475|NCT00331799|E1|Reported Event|Open Label Treatment|Open label treatment with Duloxetine for 8 weeks with dosing from 30-60 mg.
505476|NCT00331760|B3|Baseline|Total|Total of all reporting groups
505477|NCT00331760|B2|Baseline|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
505478|NCT00331760|B1|Baseline|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
505479|NCT00331760|P2|Participant Flow|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
505480|NCT00331760|P1|Participant Flow|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
505481|NCT00331760|O2|Outcome|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
505482|NCT00331760|O1|Outcome|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
505483|NCT00331760|E2|Reported Event|Cervical Cancer: IMRT + Chemotherapy (Cisplatin)|Cervical patients receive Intensity Modulated Radiation Therapy (IMRT) + Chemotherapy (cisplatin)
505484|NCT00331760|E1|Reported Event|Endometrial Cancer: IMRT|Endometrial Cancer patients receive Intensity Modulated Radiation Therapy (IMRT)
505485|NCT00331682|B1|Baseline|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
505486|NCT00331682|P1|Participant Flow|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~alvocidib: Given IV~docetaxel: Given IV"
505487|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
505488|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
505489|NCT00331682|O1|Outcome|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
505490|NCT00331682|E1|Reported Event|Docetaxel and Flavopiridol|"Patients receive docetaxel IV over 30 minutes followed 4-6 hours later by flavopiridol IV over 60 minutes on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~flavopiridol: Given IV~docetaxel: Given IV"
505491|NCT00331422|B1|Baseline|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505492|NCT00331422|P1|Participant Flow|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505493|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505494|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505495|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505496|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505497|NCT00331422|O1|Outcome|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505498|NCT00331422|O1|Outcome|Evaluable Patients (Received 4 Cycles of Therapy and Surgery)|Includes patients treated with 4 cycles of study chemotherapy regimen and surgery.
505499|NCT00331422|E1|Reported Event|Patients Who Received Treatment|Includes all patients enrolled and treated with at least one dose of chemotherapy (carboplatin - dose calculated per Calvert formula - given intravenously for 30 minutes and/or paclitaxel 175 milligrams per meter squared over 3 hours).
505500|NCT00331409|B1|Baseline|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505501|NCT00331409|P1|Participant Flow|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505502|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505503|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505504|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505505|NCT00331409|O1|Outcome|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505506|NCT00331409|E1|Reported Event|Everolimus and Imatinib Mesylate|"Everolimus: 2.5 mg daily by mouth~Imatinib Mesylate: 600 mg daily by mouth"
505507|NCT00331006|B1|Baseline|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505508|NCT00331006|P1|Participant Flow|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505509|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505510|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505511|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505512|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505513|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505514|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505515|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505516|NCT00331006|O1|Outcome|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505517|NCT00331006|E1|Reported Event|Rituximab|Rituximab administered at a dose of 375 mg/m^2 by slow intravenous infusion once per week for 4 weeks
505518|NCT00330967|B3|Baseline|Total|Total of all reporting groups
505519|NCT00330967|B2|Baseline|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
505520|NCT00330967|B1|Baseline|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
505521|NCT00330967|P2|Participant Flow|Group 2|"Femoral arterial Intralipid infusion subjects~20% Intralipid: lipid infusion"
505522|NCT00330967|P1|Participant Flow|Group 1|"Systemic Intralipid infusion subjects~20% Intralipid: lipid infusion"
505523|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505524|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505525|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505526|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505527|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505528|NCT00330967|O1|Outcome|Group 2|Femoral Intralipid infusion group
505529|NCT00330967|O1|Outcome|Group 2|"Femoral Intralipid infusion subjects~20% Intralipid: lipid infusion"
505530|NCT00330967|E2|Reported Event|Group 2|"Femoral Intralipid infusion group~20% Intralipid: lipid infusion"
505531|NCT00330967|E1|Reported Event|Group 1|"Systemic Intralipid infusion group~20% Intralipid: lipid infusion"
505532|NCT00330928|B1|Baseline|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
505534|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
505535|NCT00330928|O1|Outcome|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
505536|NCT00330928|E1|Reported Event|Intravascular Coronary Imaging|Subjects undergoing intravascular ultrasound and near infrared spectroscopy imaging
505537|NCT00330915|B1|Baseline|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505538|NCT00330915|P1|Participant Flow|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505539|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505540|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505541|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505542|NCT00330915|O1|Outcome|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505543|NCT00330915|E1|Reported Event|Pemetrexed|500 mg/m2, intravenous (IV), every 21 days x 3 cycles
505544|NCT00330876|B1|Baseline|Safety Population|Subjects who received at least one dose of Pitavastatin 2 or 4 mg once daily
505545|NCT00330876|P2|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
505546|NCT00330876|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
505547|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
505548|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
505549|NCT00330876|O2|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
505550|NCT00330876|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
505551|NCT00330876|E2|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
505552|NCT00330876|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg once daily
505553|NCT00330174|B3|Baseline|Total|Total of all reporting groups
505554|NCT00330174|B2|Baseline|Placebo|Matching placebo tablets
505555|NCT00330174|B1|Baseline|Acamprosate|Acamprosate tablets
505556|NCT00330174|P2|Participant Flow|Placebo|Matching placebo tablets
505557|NCT00330174|P1|Participant Flow|Acamprosate|Acamprosate tablets
505558|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
505559|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
505560|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
505561|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
505562|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
505563|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
505564|NCT00330174|O2|Outcome|Placebo|Matching placebo tablets
505565|NCT00330174|O1|Outcome|Acamprosate|Acamprosate tablets
505566|NCT00330174|E2|Reported Event|Placebo|Matching placebo tablets
505567|NCT00330174|E1|Reported Event|Acamprosate|Acamprosate tablets
505568|NCT00330161|B1|Baseline|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505569|NCT00330161|P1|Participant Flow|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505570|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505571|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505572|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505573|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505676|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
505574|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505575|NCT00330161|O1|Outcome|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505576|NCT00330161|E1|Reported Event|Treatment (Vorinostat)|"Patients receive oral vorinostat (SAHA) once daily on days 1-21. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve complete response (CR) after 4 courses receive an additional 3 courses. All other patients may continue treatment in the absence of disease progression or unacceptable toxicity.~Blood samples are taken on day 15 of course 1, day 1 of course 2, during the last week of course 4, and at completion of study treatment. Blood is examined for interleukin (IL)-6, IL-6 receptor, and gp130 levels."
505577|NCT00329901|B4|Baseline|Total|Total of all reporting groups
505578|NCT00329901|B3|Baseline|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505579|NCT00329901|B2|Baseline|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505580|NCT00329901|B1|Baseline|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505581|NCT00329901|P3|Participant Flow|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505582|NCT00329901|P2|Participant Flow|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
505583|NCT00329901|P1|Participant Flow|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505584|NCT00329901|O3|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505585|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505586|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505587|NCT00329901|O2|Outcome|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505588|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505589|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505590|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505591|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505592|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505593|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505594|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505595|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505596|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505597|NCT00329901|O2|Outcome|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505598|NCT00329901|O1|Outcome|Tdap + MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505599|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505600|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505601|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505602|NCT00329901|O1|Outcome|Tdap+ MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505603|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505604|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505605|NCT00329901|O2|Outcome|Tdap+Saline|Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
505606|NCT00329901|O1|Outcome|Tdap+MenACWY-CRM|Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
505607|NCT00329901|E3|Reported Event|MenACWY-CRM + Saline|Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
505608|NCT00329901|E2|Reported Event|Tdap + Saline|Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
505609|NCT00329901|E1|Reported Event|Tdap + MenACWY-CRM|Subjects received Tdap and MenACWY-CRM vaccines concomitantly, in separate arms
505610|NCT00329849|B3|Baseline|Total|Total of all reporting groups
505611|NCT00329849|B2|Baseline|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505612|NCT00329849|B1|Baseline|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505613|NCT00329849|P2|Participant Flow|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505614|NCT00329849|P1|Participant Flow|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505615|NCT00329849|O4|Outcome|MenACWY-PS_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505616|NCT00329849|O3|Outcome|MenACWY-CRM_6 to 10 Years|Subjects ≥6 to ≤10 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505617|NCT00329849|O2|Outcome|MenACWY-PS_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505618|NCT00329849|O1|Outcome|MenACWY-CRM_2 to 5 Years|Subjects ≥2 to ≤5 years of age received one vaccination of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505619|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505620|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505621|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505622|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505623|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505624|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505625|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505626|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505627|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505628|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505629|NCT00329849|O2|Outcome|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505630|NCT00329849|O1|Outcome|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505631|NCT00329849|E2|Reported Event|MenACWY-PS|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal polysaccharide vaccine (MenACWY-PS)
505632|NCT00329849|E1|Reported Event|MenACWY-CRM|Subjects ≥2 to ≤10 years of age received one dose of a quadrivalent meningococcal conjugate vaccine (MenACWY-CRM)
505633|NCT00329836|B1|Baseline|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
505634|NCT00329836|P1|Participant Flow|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
505635|NCT00329836|O1|Outcome|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
505636|NCT00329836|E1|Reported Event|Subjects With Cluster Headache|Subjects with both episodic and chronic cluster (as defined by the International Headache Society-IHS) were enrolled.
505637|NCT00329784|B5|Baseline|Total|Total of all reporting groups
505638|NCT00329784|B4|Baseline|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505639|NCT00329784|B3|Baseline|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505640|NCT00329784|B2|Baseline|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505641|NCT00329784|B1|Baseline|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505642|NCT00329784|P2|Participant Flow|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505643|NCT00329784|P1|Participant Flow|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505644|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505645|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505646|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
516739|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
505647|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505648|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505649|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505650|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505651|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505652|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505653|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505654|NCT00329784|O2|Outcome|Peanut Consumption Group|Participants assigned to the peanut consumption group were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505655|NCT00329784|O1|Outcome|Peanut Avoidance Group|Participants assigned to the peanut avoidance group were instructed to avoid exposure to peanut protein during study participation.
505656|NCT00329784|O4|Outcome|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505657|NCT00329784|O3|Outcome|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505658|NCT00329784|O2|Outcome|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505659|NCT00329784|O1|Outcome|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505660|NCT00329784|E4|Reported Event|Positive Stratum - Peanut Consumption Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505661|NCT00329784|E3|Reported Event|Positive Stratum - Peanut Avoidance Group|Participants who had a positive response to a skin prick test for peanut allergen (a wheal measuring between 1 and 4 mm) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505662|NCT00329784|E2|Reported Event|Negative Stratum - Peanut Consumption Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut consumption group. Participants were fed at least 2 g of peanut protein 3 times per week (a total of 6g). The preferred peanut source was Bamba (a peanut snack), although peanut butter was an acceptable substitute. After age 3, participants were allowed to eat whole peanuts.
505663|NCT00329784|E1|Reported Event|Negative Stratum - Peanut Avoidance Group|Participants who had a negative response to a skin prick test for peanut allergen (no measurable wheal) and were then randomized to the peanut avoidance group. Participants were instructed to avoid exposure to peanut protein during study participation.
505664|NCT00329771|B1|Baseline|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
505665|NCT00329771|P1|Participant Flow|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
505666|NCT00329771|O1|Outcome|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
505667|NCT00329771|E1|Reported Event|Episodic Migraineurs|Eligible subjects with episodic migraine (with or without aura)
505668|NCT00329745|B3|Baseline|Total|Total of all reporting groups
505669|NCT00329745|B2|Baseline|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
505670|NCT00329745|B1|Baseline|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
505671|NCT00329745|P2|Participant Flow|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
505672|NCT00329745|P1|Participant Flow|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
505673|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
505674|NCT00329745|O1|Outcome|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
505675|NCT00329745|O2|Outcome|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
505677|NCT00329745|E2|Reported Event|Placebo Group|During the primary study (NCT00197210) subjects received two oral doses of placebo.
505678|NCT00329745|E1|Reported Event|Rotarix Group|During the primary study (NCT00197210) subjects received two oral doses of Rotarix™ vaccine.
505679|NCT00329732|B3|Baseline|Total|Total of all reporting groups
505680|NCT00329732|B2|Baseline|Saline (Placebo)|
505681|NCT00329732|B1|Baseline|Lidocaine/Bupivicaine|
505682|NCT00329732|P2|Participant Flow|Saline (Placebo)|
505683|NCT00329732|P1|Participant Flow|Lidocaine/Bupivicaine|
505684|NCT00329732|O1|Outcome|Lidocaine/Bupivicaine|
505685|NCT00329732|E2|Reported Event|Saline (Placebo)|
505686|NCT00329732|E1|Reported Event|Lidocaine/Bupivicaine|
505687|NCT00329719|B5|Baseline|Total|Total of all reporting groups
505688|NCT00329719|B4|Baseline|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505689|NCT00329719|B3|Baseline|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505690|NCT00329719|B2|Baseline|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505691|NCT00329719|B1|Baseline|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505692|NCT00329719|P4|Participant Flow|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505693|NCT00329719|P3|Participant Flow|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505694|NCT00329719|P2|Participant Flow|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505695|NCT00329719|P1|Participant Flow|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505696|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505697|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505698|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505699|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505700|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505701|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505702|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505703|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505704|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505705|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505706|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505707|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505708|NCT00329719|O4|Outcome|Phase II, Arm D|"Phase II, Arm D, Group III (patients who received prior anti-VEGF therapy)~Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505709|NCT00329719|O3|Outcome|Phase II, Arm C|"Phase II, Arm C, Group II (patients undergoing surgery)~Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505710|NCT00329719|O2|Outcome|Phase II, Arm B|"Phase II, Arm B, Group I (patients not undergoing surgery)~Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505711|NCT00329719|O1|Outcome|Phase I, Arm A|"Phase I, Arm A, Dose Escalation~Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505712|NCT00329719|E4|Reported Event|Phase II, Arm D|"Patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505713|NCT00329719|E3|Reported Event|Phase II, Arm C|"Patients receive sorafenib PO BID on days 1-8 (15 doses) and temsirolimus IV at the MTD on day 1. Patients undergo surgery on day 8. After recovering from surgery, patients receive sorafenib and temsirolimus as in phase I at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV~conventional surgery: Undergo surgery"
505714|NCT00329719|E2|Reported Event|Phase II, Arm B|"Patients receive sorafenib and temsirolimus at the MTD (25mg temsirolimus and 200mg sorafenib).~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505715|NCT00329719|E1|Reported Event|Phase I, Arm A|"Patients receive sorafenib orally (PO) twice daily (BID) on days 1-28 and temsirolimus intravenously (IV) over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of temsirolimus until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~sorafenib tosylate: Given PO~temsirolimus: Given IV"
505716|NCT00329641|B1|Baseline|Sorafenib, Carboplatin, Paclitaxel|
505717|NCT00329641|P1|Participant Flow|Sorafenib, Carboplatin, Paclitaxel|Standard carboplatin and paclitaxel doses with the addition of sorafenib (800 mg daily)
505718|NCT00329641|O1|Outcome|Intervention|Sorafenib, Carboplatin, Paclitaxel
505719|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
505720|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
505721|NCT00329641|O1|Outcome|Sorafenib, Carboplatin, Paclitaxel|
505722|NCT00329641|E1|Reported Event|Intervention|Sorafenib, Carboplatin, Paclitaxel
505723|NCT00329602|B3|Baseline|Total|Total of all reporting groups
505724|NCT00329602|B2|Baseline|Double-Blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505725|NCT00329602|B1|Baseline|Double-Blind Placebo|Matching placebo tablets
505726|NCT00329602|P3|Participant Flow|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505727|NCT00329602|P2|Participant Flow|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505728|NCT00329602|P1|Participant Flow|Double-blind Placebo|Matching placebo tablets
505729|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not excluded from the IRLS post-hoc analysis
505730|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not excluded from the IRLS post-hoc analysis
505731|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Double-Blind Ropinirole participants (receiving Ropinirole IR [immediate release] tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day) who were not in the center groups with the highest or lowest treatment effects
505732|NCT00329602|O1|Outcome|Double-blind Placebo|Double-Blind Placebo participants (receiving matching placebo tablets) who were not in the center groups with the highest or lowest treatment effects
505733|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505734|NCT00329602|O4|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505735|NCT00329602|O3|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505736|NCT00329602|O2|Outcome|Double-blind Placebo|Matching placebo tablets
505737|NCT00329602|O1|Outcome|Overall Study|
505738|NCT00329602|O1|Outcome|Open-label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505739|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505740|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505741|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505742|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505743|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505744|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505745|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505746|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505747|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505748|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505749|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505750|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505751|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505752|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505753|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505754|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505755|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505756|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505757|NCT00329602|O2|Outcome|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505758|NCT00329602|O1|Outcome|Double-blind Placebo|Matching placebo tablets
505759|NCT00329602|E3|Reported Event|Open-Label Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505760|NCT00329602|E2|Reported Event|Double-blind Ropinirole IR|Ropinirole IR (immediate release) tablets containing ropinirole hydrochloride equivalent to 0.25 mg, 0.5 mg, 1.0 mg, or 2.0 mg of the active drug substance, taken once a day
505761|NCT00329602|E1|Reported Event|Double-blind Placebo|Matching placebo tablets
505762|NCT00329550|B4|Baseline|Total|Total of all reporting groups
505763|NCT00329550|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505764|NCT00329550|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505765|NCT00329550|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505766|NCT00329550|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505767|NCT00329550|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505768|NCT00329550|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505769|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505770|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505771|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
516740|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
505772|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505773|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505774|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505775|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505776|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505777|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505778|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505779|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505780|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505781|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505782|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505783|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505784|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505785|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505786|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505787|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505788|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505789|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505790|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505791|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505792|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505793|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505794|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505795|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505796|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505797|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505798|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505799|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505800|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505801|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505802|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506430|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
505803|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505804|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505805|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505806|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505807|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505808|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505809|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505810|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505811|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505812|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505813|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505814|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505815|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505816|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505817|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505818|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505819|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505820|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505821|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505822|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505823|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505824|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505825|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505826|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505827|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505828|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505829|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505830|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505831|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505832|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505833|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506431|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
505834|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505835|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505836|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505837|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505838|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505839|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505840|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505841|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505842|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505843|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505844|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505845|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505846|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505847|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505848|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505849|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505850|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505851|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505852|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505853|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505854|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505855|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505856|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505857|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505858|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505859|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505860|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505861|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505862|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505863|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505864|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506416|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
505865|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505866|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505867|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505868|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505869|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505870|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505871|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505872|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505873|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505874|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505875|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505876|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505877|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505878|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505879|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505880|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505881|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505882|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505883|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505884|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505885|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505886|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505887|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505888|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505889|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505890|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505891|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505892|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505893|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505894|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505895|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506432|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
505896|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505897|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505898|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505899|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505900|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505901|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505902|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505903|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505904|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505905|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505906|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505907|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505908|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505909|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505910|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505911|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505912|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505913|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505914|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505915|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505916|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505917|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505918|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505919|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505920|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505921|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505922|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505923|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505924|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505925|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505926|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506433|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
505927|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505928|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505929|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505930|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505931|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505932|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505933|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505934|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505935|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505936|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505937|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505938|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505939|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505940|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505941|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505942|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505943|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505944|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505945|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505946|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505947|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505948|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505949|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505950|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505951|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505952|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505953|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505954|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505955|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505956|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505957|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506417|NCT00329407|E1|Reported Event|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
505958|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505959|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505960|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505961|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505962|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505963|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505964|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505965|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505966|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505967|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505968|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505969|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505970|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505971|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505972|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505973|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505974|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505975|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505976|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505977|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505978|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505979|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505980|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505981|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505982|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505983|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505984|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505985|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505986|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505987|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505988|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506418|NCT00329238|B3|Baseline|Total|Total of all reporting groups
505989|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505990|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505991|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505992|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505993|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505994|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505995|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505996|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505997|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505998|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
505999|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506000|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506001|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506002|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506003|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506004|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506005|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506006|NCT00329550|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506007|NCT00329550|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506008|NCT00329550|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506009|NCT00329550|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (NCT00291668) and this extension study for all 40 subjects who entered this extension study, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
506010|NCT00329550|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 40 subjects who entered this extension study.
506011|NCT00329550|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506012|NCT00329550|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506013|NCT00329550|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506014|NCT00329524|B1|Baseline|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
506015|NCT00329524|P1|Participant Flow|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
506016|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
516741|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
506017|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
506018|NCT00329524|O1|Outcome|Active Versus Sham TMS|Active or sham TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging according to a randomized schedule. This area will then be targeted either for active treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days or sham treatment of the same duration.
506019|NCT00329524|E1|Reported Event|Active Versus Sham Treatment|"Subjects randomly assigned to active and sham TMS separated by one week interval.~Repetitive Transcranial Magnetic Stimulation (rTMS): TMS will initially be targeted to asymmetric cortical activation in one hemisphere, as defined by PET-CT imaging. TMS will then be optimized by identifying the area of maximal tinnitus suppression, within the area of asymmetry, by delivering single 1-Hz pulses of TMS at the MT. The area of maximal tinnitus suppression, as reported by the patient, will then be targeted for treatment with rTMS at 1-Hz frequency, delivering 1800 pulses at 110% MT on each of 5 consecutive treatment days.If no area of maximal tinnitus suppression can be found in the hemisphere initially targeted for treatment based on PET, we will perform the optimization procedure in a homologous region of the opposite cerebral hemisphere to determine if maximal area of suppression can be found there. Each group will then crossover to sham and active stimulation conditions, respectiv"
506020|NCT00329433|B3|Baseline|Total|Total of all reporting groups
506021|NCT00329433|B2|Baseline|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
506022|NCT00329433|B1|Baseline|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
506023|NCT00329433|P2|Participant Flow|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
506024|NCT00329433|P1|Participant Flow|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
506025|NCT00329433|O2|Outcome|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
506026|NCT00329433|O1|Outcome|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
506027|NCT00329433|E2|Reported Event|Heparin|Patients randomized to the heparin group received 5000 units of LDUH via subcutaneous administration three times a day (0900, 1300, and 2100).
506028|NCT00329433|E1|Reported Event|Desirudin|Patients randomized to the desirudin group received desirudin 15mg via subcutaneous administration twice daily (0900 and 2100), with saline placebo given once daily at 1300.
506029|NCT00329420|B4|Baseline|Total|Total of all reporting groups
506030|NCT00329420|B3|Baseline|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506031|NCT00329420|B2|Baseline|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506032|NCT00329420|B1|Baseline|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506033|NCT00329420|P3|Participant Flow|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506034|NCT00329420|P2|Participant Flow|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506035|NCT00329420|P1|Participant Flow|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506036|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506037|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506038|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506039|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506040|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506041|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506042|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506043|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
516742|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
506044|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506045|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506046|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506047|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506048|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506049|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506050|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506051|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506052|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506053|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506054|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506055|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506056|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506057|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506058|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506059|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506060|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506061|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506062|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506063|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506064|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506065|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506066|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506067|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506068|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506069|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506070|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506071|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506072|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506073|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506074|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506075|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506076|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506077|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506078|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506079|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506080|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506081|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506082|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506083|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506084|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506085|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506086|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506087|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506088|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506089|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506090|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506091|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506092|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506093|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506094|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506095|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506096|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506097|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506098|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506099|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506100|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506101|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506102|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506103|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506104|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506105|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506106|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506107|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506108|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506109|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506110|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506111|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506112|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506113|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506114|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506115|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506116|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506117|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506118|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506119|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506120|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506121|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506122|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506123|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506124|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506125|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506126|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506127|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506128|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506129|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506419|NCT00329238|B2|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506420|NCT00329238|B1|Baseline|Dabigatran|150 mg twice daily, total daily dose 300 mg
506130|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506131|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506132|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506133|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506134|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506135|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506136|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506137|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506138|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506139|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506140|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506141|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506142|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506143|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506144|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506145|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506146|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506147|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506148|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506149|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506150|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506151|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506152|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506153|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506154|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506155|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506156|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506157|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506158|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506159|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506160|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506161|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506162|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506163|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506164|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506165|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506166|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506167|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506168|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506169|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506170|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506171|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506172|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506173|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506174|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506175|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506176|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506177|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506178|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506179|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506180|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506181|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506182|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506183|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506184|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506185|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506186|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506421|NCT00329238|P2|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506422|NCT00329238|P1|Participant Flow|Dabigatran|150 mg twice daily, total daily dose 300 mg
506187|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506188|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506189|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506190|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506191|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506192|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506193|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506194|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506195|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506196|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506197|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506198|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506199|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506200|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506201|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506202|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506203|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506204|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506205|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506206|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506207|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506208|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506209|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506210|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506211|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506212|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506213|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506214|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506215|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506216|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506217|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506218|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506219|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506220|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506221|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506222|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506223|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506224|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506225|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506226|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506227|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506228|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506229|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506230|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506231|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506232|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506233|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506234|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506235|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506236|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506237|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506238|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506239|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506240|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506241|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506242|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506243|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506423|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506424|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506244|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506245|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506246|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506247|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506248|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506249|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506250|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506251|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506252|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506253|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506254|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506255|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506256|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506257|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506258|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506259|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506260|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506261|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506262|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506263|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506264|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506265|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506266|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506267|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506268|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506269|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506270|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506271|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506272|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506273|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506274|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506275|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506276|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506277|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506278|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506279|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506280|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506281|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506282|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506283|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506284|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506285|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506286|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506287|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506288|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506289|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506290|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506291|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506292|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506293|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506294|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506295|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506296|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506297|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506298|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506299|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506300|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506425|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506426|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506301|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506302|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506303|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506304|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506305|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506306|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506307|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506308|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506309|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506310|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506311|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506312|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506313|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506314|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506315|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506316|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506317|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506318|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506319|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506320|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506321|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506322|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506323|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506324|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506325|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506326|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506327|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506328|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506329|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506330|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506331|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506332|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506333|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506334|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506335|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506336|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506337|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506338|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506339|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506340|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506341|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506342|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506343|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506344|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506345|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506346|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506347|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506348|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506349|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506350|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506351|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506352|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506353|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506354|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506355|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506356|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506357|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506427|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506428|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506358|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506359|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506360|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506361|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506362|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506363|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506364|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506365|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506366|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506367|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506368|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506369|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506370|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506371|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506372|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506373|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506374|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506375|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506376|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506377|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506378|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506379|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506380|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506381|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506382|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506383|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506384|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506385|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506386|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506387|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506388|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506389|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506390|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506391|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506392|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506393|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506394|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506395|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506396|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506397|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506398|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506399|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506400|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506401|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506402|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506403|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506404|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506405|NCT00329420|O3|Outcome|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506406|NCT00329420|O2|Outcome|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506407|NCT00329420|O1|Outcome|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506408|NCT00329420|E5|Reported Event|Total 2 (Treatment With CZP in Main Study and Extension Study)|This includes all adverse event data from the 6-week double-blind main study (N00291668) and this extension study for all 46 subjects who entered this extension study C87048, whilst they were receiving treatment with certolizumab pegol (CZP) in either study. Adverse events recorded in the double-blind main study (NCT00291668) for subjects who received Placebo treatment during that study are not included here.
506409|NCT00329420|E4|Reported Event|Total 1 (This Extension Study Only)|This includes all adverse event data collected in this extension study for all 46 subjects who entered this extension study.
506410|NCT00329420|E3|Reported Event|CZP 400 mg / CZP 400 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506411|NCT00329420|E2|Reported Event|CZP 400 mg / CZP 200 mg|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Certolizumab pegol (CZP) 200 mg (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506412|NCT00329420|E1|Reported Event|CZP 400 mg / Placebo|Certolizumab pegol (CZP) 400 mg (3 doses 2-weekly then 5 doses 4-weekly) in this extension study / Placebo (3 doses 2-weekly) in the 6-week double-blind main study (NCT00291668)
506413|NCT00329407|B1|Baseline|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
506414|NCT00329407|P1|Participant Flow|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
506415|NCT00329407|O1|Outcome|Topiramate Treatment|In this open label non-placebo controlled trial all subjects received topiramate, the active medication.
506434|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506435|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506436|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506437|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506438|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506439|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506440|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506441|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506442|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506443|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506444|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506445|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506446|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506447|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506448|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506449|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506450|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506451|NCT00329238|O2|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506452|NCT00329238|O1|Outcome|Dabigatran|150 mg twice daily, total daily dose 300 mg
506453|NCT00329238|E4|Reported Event|Post Warfarin|
506454|NCT00329238|E3|Reported Event|Post Dabigatran|
506455|NCT00329238|E2|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
506456|NCT00329238|E1|Reported Event|Dabigatran|150 mg twice daily, total daily dose 300 mg
506457|NCT00329160|B1|Baseline|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506458|NCT00329160|P1|Participant Flow|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506459|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506460|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506461|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506462|NCT00329160|O1|Outcome|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506463|NCT00329160|E1|Reported Event|Rosuvastatin|rosuvastatin 2.5 mg once daily; in those whose LDL-C remained >80 mg/dl after 4 weeks of treatment, the dosage could be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan. Subjects attended follow-up visits every 4 weeks over 76 weeks after starting treatment with rosuvastatin.
506464|NCT00329108|B3|Baseline|Total|Total of all reporting groups
506465|NCT00329108|B2|Baseline|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
506466|NCT00329108|B1|Baseline|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
506467|NCT00329108|P2|Participant Flow|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
506468|NCT00329108|P1|Participant Flow|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
506469|NCT00329108|O2|Outcome|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
506470|NCT00329108|O1|Outcome|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
506471|NCT00329108|E2|Reported Event|Olanzapine|Olanzapine was started at 15 mg/day (15 mg once daily [QD]) on Day 1, and remained at this dosage until Day 7. The dosage was adjusted on the basis of clinical status up to 20 mg/day at the investigator’s discretion.
506472|NCT00329108|E1|Reported Event|Ziprasidone|Ziprasidone was initiated at a dosage of 80 mg/day (40 mg BID) on Day 1 and then was titrated to 120 mg/day (60 mg BID) from Day 3. From Day 7, the dosage was adjusted between 120 to 160 mg/day on the basis of clinical status at the investigator’s discretion.
506473|NCT00329030|B3|Baseline|Total|Total of all reporting groups
506474|NCT00329030|B2|Baseline|R-BEAM|Rituxan/BEAM
506475|NCT00329030|B1|Baseline|B-BEAM|Bexxar/BEAM
506476|NCT00329030|P2|Participant Flow|R-BEAM|Patients received Rituxan/BEAM, with Rituxan 375 mg/m2 IV Days -19 and -12, BCNU 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
506477|NCT00329030|P1|Participant Flow|B-BEAM|Patients received Bexxar/BEAM with the dosimetric dose of 5 mCi Bexxar on Day -19 and the therapeutic dose calculated to administer 75 cGy total body dose (TBD) on Day -12. Patients will then receive carmustine (BCNU) 300 mg/m2 Day -6, Etoposide 100 mg/m2 BID Days -5 to -2, Cytarabine 100 mg/m2 BID Days -5 to -2, and Melphalan 140 mg/m2 Day -1 followed by ASCT
506478|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506479|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506480|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506481|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506482|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506483|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506484|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506485|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506486|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506487|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506488|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506489|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506490|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506491|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506492|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506493|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506494|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506495|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506496|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506497|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506498|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506499|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506500|NCT00329030|O2|Outcome|R-BEAM|Rituxan/BEAM
506501|NCT00329030|O1|Outcome|B-BEAM|Bexxar/BEAM
506502|NCT00329030|E2|Reported Event|R-BEAM|Rituxan/BEAM
506503|NCT00329030|E1|Reported Event|B-BEAM|Bexxar/BEAM
506504|NCT00328926|B4|Baseline|Total|Total of all reporting groups
506505|NCT00328926|B3|Baseline|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506506|NCT00328926|B2|Baseline|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506507|NCT00328926|B1|Baseline|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506508|NCT00328926|P3|Participant Flow|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506509|NCT00328926|P2|Participant Flow|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506571|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
516743|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
506510|NCT00328926|P1|Participant Flow|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506511|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506512|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506513|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506514|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506515|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506516|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506517|NCT00328926|O3|Outcome|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506518|NCT00328926|O2|Outcome|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
508748|NCT00325819|B2|Baseline|Placebo|Subjects who were randomized to receive placebo
506519|NCT00328926|O1|Outcome|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506520|NCT00328926|E3|Reported Event|Placebo|Placebo administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506521|NCT00328926|E2|Reported Event|Luveris® 25 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 25 IU administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum E2 levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506522|NCT00328926|E1|Reported Event|Luveris® 75 IU|Recombinant human luteinizing hormone (r-hLH, lutropin alfa, Luveris®), 75 international unit (IU) administered subcutaneously once daily along with fixed dose of recombinant human follicle stimulating hormone (r-hFSH, follitropin alfa) 75 to 150 IU subcutaneously for 7 days. After 7 days of treatment, if the participant's response was suboptimal, based on follicular growth and serum estradiol (E2) levels, follitropin alfa dose adjusted to maximal dose of 225 IU. When the follicular response was adequate, ovulation was triggered by a single 250 microgram subcutaneous injection of recombinant human chorionic gonadotropin (r-hCG, choriogonadotropin alfa). Duration of treatment cycle was up to 14 days, or maximum up to 21 days (if follicular maturation is imminent, based upon follicular growth and E2 levels). Total duration was up to 3 treatment cycles.
506523|NCT00328861|B3|Baseline|Total|Total of all reporting groups
506524|NCT00328861|B2|Baseline|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506525|NCT00328861|B1|Baseline|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506526|NCT00328861|P2|Participant Flow|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506527|NCT00328861|P1|Participant Flow|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506528|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506529|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506530|NCT00328861|O2|Outcome|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506531|NCT00328861|O1|Outcome|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506532|NCT00328861|E2|Reported Event|NK Cells + IL-2: Renal Cell|Renal cell (kidney cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506533|NCT00328861|E1|Reported Event|NK Cells + IL-2: Melanoma|Melanoma (skin cancer). Cyclophosphamide 60 mg/kg/day intravenous on days -8 and -7. Fludarabine 25 mg/m^2 day intravenous on days -6 through -2. IL-2 720,000 IU/kg/intravenous every 8 hours for up to 5 days. Thirty minutes infusion of natural killer (NK) cells 2 days after last dose of chemotherapy.
506534|NCT00328783|B1|Baseline|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
506535|NCT00328783|P1|Participant Flow|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
506536|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC): The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
506537|NCT00328783|O1|Outcome|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
506538|NCT00328783|E1|Reported Event|Active Breathing Coordinator|"Patients breathe through the ABC device~Active Breathing Coordinator (ABC) : The generated dose distributions from the free-breathing versus ABC plans will be compared to assess the volume of normal tissue, as well as target volume irradiated, utilizing dose-volume histograms."
506539|NCT00328770|B1|Baseline|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
506540|NCT00328770|P1|Participant Flow|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
506541|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
506542|NCT00328770|O1|Outcome|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
506543|NCT00328770|O1|Outcome|Patient Survival|1 and 4 year patient survival
506544|NCT00328770|E1|Reported Event|All Study Patients|All patients with hepatocellular carcinoma receiving sirolimus-based immunosuppression after liver transplantation
506545|NCT00328627|B13|Baseline|Total|Total of all reporting groups
506546|NCT00328627|B12|Baseline|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506547|NCT00328627|B11|Baseline|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506548|NCT00328627|B10|Baseline|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506549|NCT00328627|B9|Baseline|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506550|NCT00328627|B8|Baseline|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506551|NCT00328627|B7|Baseline|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506552|NCT00328627|B6|Baseline|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506553|NCT00328627|B5|Baseline|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506554|NCT00328627|B4|Baseline|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506555|NCT00328627|B3|Baseline|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506556|NCT00328627|B2|Baseline|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506557|NCT00328627|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506558|NCT00328627|P12|Participant Flow|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506559|NCT00328627|P11|Participant Flow|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506560|NCT00328627|P10|Participant Flow|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506561|NCT00328627|P9|Participant Flow|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506562|NCT00328627|P8|Participant Flow|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506563|NCT00328627|P7|Participant Flow|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506564|NCT00328627|P6|Participant Flow|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506565|NCT00328627|P5|Participant Flow|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506566|NCT00328627|P4|Participant Flow|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506567|NCT00328627|P3|Participant Flow|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506568|NCT00328627|P2|Participant Flow|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506569|NCT00328627|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506570|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506572|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506573|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506574|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506575|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506576|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506577|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506578|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506579|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506580|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506581|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506582|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506583|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506584|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506585|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506586|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506587|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506588|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506589|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506590|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506591|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506592|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506593|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506594|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506595|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506596|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506597|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506598|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506599|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506600|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506601|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506602|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506603|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506604|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506605|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506606|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506607|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506608|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506609|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506649|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506610|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506611|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506612|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506613|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506614|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506615|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506616|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506617|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506618|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506619|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506620|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506621|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506622|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506623|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506624|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506625|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506626|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506627|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506628|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506629|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506630|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506631|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506632|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506633|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506634|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506635|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506636|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506637|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506638|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506639|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506640|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506641|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506642|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506643|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506644|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506645|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506646|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506647|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506648|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506650|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506651|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506652|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506653|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506654|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506655|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506656|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506657|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506658|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506659|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506660|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506661|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506662|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506663|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506664|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506665|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506666|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506667|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506668|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506669|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506670|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506671|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506672|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506673|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506674|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506675|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506676|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506677|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506678|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506679|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506680|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506681|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506682|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506683|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506684|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506685|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506686|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506687|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506688|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506689|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506690|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506691|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506692|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506693|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506694|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506695|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506696|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506697|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506698|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506699|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506700|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506701|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506702|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506703|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506704|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506705|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506706|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506707|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506708|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506709|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506710|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506711|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506712|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506713|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506714|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506715|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506716|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506717|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506718|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506719|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506720|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506721|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506722|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506723|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506724|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506725|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506726|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506920|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506727|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506728|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506729|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506730|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506731|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506732|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506733|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506734|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506735|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506736|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506737|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506738|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506739|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506740|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506741|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506742|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506743|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506744|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506745|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506746|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506747|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506748|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506749|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506750|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506751|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506752|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506753|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506754|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506755|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506756|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506757|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506758|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506759|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506760|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506761|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506762|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506763|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506764|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506765|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508749|NCT00325819|B1|Baseline|Acetaminophen|Subjects who were randomized to receive acetaminophen
506766|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506767|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506768|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506769|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506770|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506771|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506772|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506773|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506774|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506775|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506776|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506777|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506778|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506779|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506780|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506781|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506782|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506783|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506784|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506785|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506786|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506787|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506788|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506789|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506790|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506791|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506792|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506793|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506794|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506795|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506796|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506797|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506798|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506799|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506800|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506801|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506802|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506803|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507758|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506804|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506805|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506806|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506807|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506808|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506809|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506810|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506811|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506812|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506813|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506814|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506815|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506816|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506817|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506818|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506819|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506820|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506821|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506822|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506823|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506824|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506825|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506826|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506827|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506828|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506829|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506830|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506831|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506832|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506833|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506834|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506835|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506836|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506837|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506838|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506839|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506840|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506841|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506842|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
509192|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
506843|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506844|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506845|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506846|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506847|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506848|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506849|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506850|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506851|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506852|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506853|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506854|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506855|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506856|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506857|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506858|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506859|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506860|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506861|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506862|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506863|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506864|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506865|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506866|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506867|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506868|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506869|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506870|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506871|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506872|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506873|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506874|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506875|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506876|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506877|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506878|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506879|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506880|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507759|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506881|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506882|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506883|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506884|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506885|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506886|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506887|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506888|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506889|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506890|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506891|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506892|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506893|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506894|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506895|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506896|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506897|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506898|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506899|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506900|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506901|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506902|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506903|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506904|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506905|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506906|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506907|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506908|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506909|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506910|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506911|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506912|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506913|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506914|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506915|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506916|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506917|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506918|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506919|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506921|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506922|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506923|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506924|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506925|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506926|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506927|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506928|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506929|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506930|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506931|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506932|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506933|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506934|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506935|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506936|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506937|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506938|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506939|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506940|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506941|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506942|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506943|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506944|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506945|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506946|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506947|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506948|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506949|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506950|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506951|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506952|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506953|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506954|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506955|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506956|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506957|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506958|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507760|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506959|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506960|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506961|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506962|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506963|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506964|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506965|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506966|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506967|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506968|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506969|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506970|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506971|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506972|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
506973|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
506974|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
506975|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506976|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506977|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506978|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506979|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506980|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506981|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506982|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506983|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506984|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506985|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506986|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506987|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506988|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506989|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
506990|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506991|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506992|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
506993|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506994|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506995|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
506996|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508143|NCT00328172|B3|Baseline|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
506997|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506998|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
506999|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507000|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507001|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507002|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507003|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507004|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507005|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507006|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507007|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507008|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507009|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507010|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507011|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507012|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507013|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507014|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507015|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507016|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507017|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507018|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507019|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507020|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507021|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507022|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507023|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507024|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507025|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507026|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507027|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507028|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507029|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507030|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507031|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507032|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507033|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507034|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508144|NCT00328172|B2|Baseline|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
507035|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507036|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507037|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507038|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507039|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507040|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507041|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507042|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507043|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507044|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507045|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507046|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507047|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507048|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507049|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507050|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507051|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507052|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507053|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507054|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507055|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507056|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507057|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507058|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507059|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507060|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507061|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507062|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507063|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507064|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507065|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507066|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507067|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507068|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507069|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507070|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507071|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507072|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508145|NCT00328172|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
507073|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507074|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507075|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507076|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507077|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507078|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507079|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507080|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507081|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507082|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507083|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507084|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507085|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507086|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507087|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507088|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507089|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507090|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507091|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507092|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507093|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507094|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507095|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507096|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507097|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507098|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507099|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507100|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507101|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507102|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507103|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507104|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507105|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507106|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507107|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507108|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507109|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507110|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507111|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508146|NCT00328172|P5|Participant Flow|Metformin|Patients randomized to receive treatment with metformin
507112|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507113|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507114|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507115|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507116|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507117|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507118|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507119|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507120|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507121|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507122|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507123|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507124|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507125|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507126|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507127|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507128|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507129|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507130|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507131|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507132|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507133|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507134|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507135|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507136|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507137|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507138|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507139|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507140|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507141|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507142|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507143|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507144|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507145|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507146|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507147|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507148|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507149|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508147|NCT00328172|P4|Participant Flow|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
507150|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507151|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507152|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507153|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507154|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507155|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507156|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507157|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507158|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507159|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507160|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507161|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507162|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507163|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507164|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507165|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507166|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507167|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507168|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507169|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507170|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507171|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507172|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507173|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507174|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507175|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507176|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507177|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507178|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507179|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507180|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507181|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507182|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507183|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507184|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507185|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507186|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507187|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508148|NCT00328172|P3|Participant Flow|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
507188|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507189|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507190|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507191|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507192|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507193|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507194|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507195|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507196|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507197|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507198|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507199|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507200|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507201|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507202|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507203|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507204|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507205|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507206|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507207|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507208|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507209|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507210|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507211|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507212|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507213|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507214|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507215|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507216|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507217|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507218|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507219|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507220|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507221|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507222|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507223|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507224|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507225|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507226|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507227|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507228|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507229|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507230|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507231|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507232|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507233|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507234|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507235|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507236|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507237|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507238|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507239|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507240|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507241|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507242|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507243|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507244|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507245|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507246|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507247|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507248|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507249|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507250|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507251|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507252|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507253|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507254|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507255|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507256|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507257|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507258|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507259|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507260|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507261|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507262|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507263|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508149|NCT00328172|P2|Participant Flow|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
507264|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507265|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507266|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507267|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507268|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507269|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507270|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507271|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507272|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507273|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507274|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507275|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507276|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507277|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507278|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507279|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507280|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507281|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507282|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507283|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507284|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507285|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507286|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507287|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507288|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507289|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507290|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507291|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507292|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507293|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507294|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507295|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507296|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507297|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507298|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507299|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507300|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507301|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507302|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507303|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507304|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507305|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507306|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507307|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507308|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507309|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507310|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507311|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507312|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507313|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507314|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507315|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507316|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507317|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507318|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507319|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507320|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507321|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507322|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507323|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507324|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507325|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507326|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507327|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507328|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507329|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507330|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507331|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507332|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507333|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507334|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507335|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507336|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507337|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507338|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507339|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508150|NCT00328172|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
507340|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507341|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507342|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507343|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507344|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507345|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507346|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507347|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507348|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507349|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507350|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507351|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507352|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507353|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507354|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507355|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507356|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507357|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507358|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507359|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507360|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507361|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507362|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507363|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507364|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507365|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507366|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507367|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507368|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507369|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507370|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507371|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507372|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507373|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507374|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507375|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507376|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507377|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507378|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507379|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507380|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507381|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507382|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507383|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507384|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507385|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507386|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507387|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507388|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507389|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507390|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507391|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507392|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507393|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507394|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507395|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507396|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507397|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507398|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507399|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507400|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507401|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507402|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507403|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507404|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507405|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507406|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507407|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507408|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507409|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507410|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507411|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507412|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507413|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507414|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507415|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508151|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
507416|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507417|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507418|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507419|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507420|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507421|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507422|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507423|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507424|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507425|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507426|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507427|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507428|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507429|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507430|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507431|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507432|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507433|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507434|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507435|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507436|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507437|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507438|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507439|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507440|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507441|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507442|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507443|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507444|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507445|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507446|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507447|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507448|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507449|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507450|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507451|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507452|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507453|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507454|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507455|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507456|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507457|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507458|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507459|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507460|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507461|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507462|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507463|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507464|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507465|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507466|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507467|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507468|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507469|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507470|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507471|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507472|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507473|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507474|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507475|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507476|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507477|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507478|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507479|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507480|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507481|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507482|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507483|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507484|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507485|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507486|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507487|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507488|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507489|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507490|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507491|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508152|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
507492|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507493|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507494|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507495|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507496|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507497|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507498|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507499|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507500|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507501|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507502|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507503|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507504|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507505|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507506|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507507|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507508|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507509|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507510|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507511|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507512|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507513|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507514|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507515|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507516|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507517|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507518|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507519|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507520|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507521|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507522|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507523|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507524|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507525|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507526|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507527|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507528|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507529|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507530|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507531|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507532|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507533|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507534|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507535|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507536|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507537|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507538|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507539|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507540|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507541|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507542|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507543|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507544|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507545|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507546|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507547|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507548|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507549|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507550|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507551|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507552|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507553|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507554|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507555|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507556|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507557|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507558|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507559|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507560|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507561|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507562|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507563|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507564|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507565|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507566|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507567|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508153|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
507568|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507569|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507570|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507571|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507572|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507573|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507574|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507575|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507576|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507577|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507578|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507579|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507580|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507581|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507582|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507583|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507584|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507585|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507586|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507587|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507588|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507589|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507590|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507591|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507592|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507593|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507594|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507595|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507596|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507597|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507598|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507599|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507600|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507601|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507602|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507603|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507604|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507605|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507606|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507607|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507608|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507609|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507610|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507611|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507612|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507613|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507614|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507615|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507616|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507617|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507618|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507619|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507620|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507621|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507622|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507623|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507624|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507625|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507626|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507627|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507628|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507629|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507630|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507631|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507632|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507633|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507634|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507635|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507636|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507637|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507638|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507639|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507640|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507641|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507642|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507643|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508154|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
507644|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507645|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507646|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507647|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507648|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507649|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507650|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507651|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507652|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507653|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507654|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507655|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507656|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507657|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507658|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507659|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507660|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507661|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507662|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507663|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507664|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507665|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507666|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507667|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507668|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507669|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507670|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507671|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507672|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507673|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507674|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507675|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507676|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507677|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507678|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507679|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507680|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507681|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507682|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507683|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507684|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507685|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507686|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507687|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507688|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507689|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507690|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507691|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507692|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507693|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507694|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507695|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507696|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507697|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507698|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507699|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507700|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507701|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507702|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507703|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507704|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507705|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507706|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507707|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507708|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507709|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507710|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507711|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507712|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507713|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507714|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507715|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507716|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507717|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507718|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507719|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508155|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
507720|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507721|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507722|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507723|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507724|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507725|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507726|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507727|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507728|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507729|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507730|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507731|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507732|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507733|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507734|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507735|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507736|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507737|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507738|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507739|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507740|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507741|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507742|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507743|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507744|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507745|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507746|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507747|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507748|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507749|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507750|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507751|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507752|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507753|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507754|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507755|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507756|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507757|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507761|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507762|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507763|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507764|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507765|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507766|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507767|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507768|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507769|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507770|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507771|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507772|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507773|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507774|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507775|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507776|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507777|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507778|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507779|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507780|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507781|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507782|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507783|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507784|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507785|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507786|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507787|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507788|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507789|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507790|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507791|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507792|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507793|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507794|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507795|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507796|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507797|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507798|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508156|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
507799|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507800|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507801|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507802|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507803|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507804|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507805|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507806|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507807|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507808|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507809|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507810|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507811|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507812|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507813|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507814|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507815|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507816|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507817|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507818|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507819|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507820|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507821|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507822|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507823|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507824|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507825|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507826|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507827|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507828|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507829|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507830|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507831|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507832|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507833|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507834|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507835|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507836|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507837|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507838|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
509193|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
507839|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507840|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507841|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507842|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507843|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507844|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507845|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507846|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507847|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507848|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507849|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507850|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507851|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507852|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507853|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507854|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507855|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507856|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507857|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507858|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507859|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507860|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507861|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507862|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507863|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507864|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507865|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507866|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507867|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507868|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507869|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507870|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507871|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507872|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507873|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507874|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507875|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507876|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507877|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507878|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
516744|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
507879|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507880|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507881|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507882|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507883|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507884|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507885|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507886|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507887|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507888|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507889|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507890|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507891|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507892|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507893|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507894|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507895|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507896|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507897|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507898|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507899|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507900|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507901|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507902|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507903|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507904|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507905|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
507906|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
507907|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
507908|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507909|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507910|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507911|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507912|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507913|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507914|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507915|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507916|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507917|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
509194|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
507918|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507919|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507920|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507921|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507922|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507923|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507924|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507925|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507926|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507927|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507928|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507929|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507930|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507931|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507932|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507933|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507934|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507935|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507936|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507937|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507938|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507939|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507940|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507941|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507942|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507943|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507944|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507945|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507946|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507947|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507948|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507949|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507950|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507951|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507952|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507953|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507954|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507955|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507956|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507957|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507958|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507959|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507960|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507961|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507962|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507963|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507964|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507965|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507966|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507967|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507968|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507969|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507970|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507971|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507972|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507973|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507974|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507975|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507976|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507977|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507978|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507979|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507980|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507981|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507982|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507983|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507984|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507985|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507986|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507987|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507988|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507989|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507990|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507991|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
507992|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507993|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507994|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
507995|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507996|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507997|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
507998|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
507999|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508000|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508001|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508002|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508003|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508004|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
508005|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
508006|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
508007|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508008|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508009|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508010|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508011|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508012|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508013|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508014|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508015|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508016|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508017|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508018|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508019|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508020|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508021|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508022|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508023|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508024|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508025|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508026|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508027|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508028|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508029|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508030|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508031|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508157|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
508032|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508033|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508034|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508035|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508036|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508037|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508038|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508039|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508040|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508041|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508042|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508043|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508044|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508045|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45 mg|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508046|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508047|NCT00328627|O8|Outcome|Alogliptin 12.5 mg + Pioglitazone 30 mg|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508048|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508049|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508050|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508051|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508052|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508053|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508054|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508055|NCT00328627|O12|Outcome|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508056|NCT00328627|O11|Outcome|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508057|NCT00328627|O10|Outcome|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508058|NCT00328627|O9|Outcome|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508059|NCT00328627|O8|Outcome|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508060|NCT00328627|O7|Outcome|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508061|NCT00328627|O6|Outcome|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508062|NCT00328627|O5|Outcome|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508063|NCT00328627|O4|Outcome|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508064|NCT00328627|O3|Outcome|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508065|NCT00328627|O2|Outcome|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508066|NCT00328627|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508067|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).
508068|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).
508069|NCT00328627|O1|Outcome|Pioglitazone Alone|Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).
508158|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
508070|NCT00328627|O3|Outcome|Alogliptin 25 + Pioglitazone|"Alogliptin 25 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 25 mg + Pioglitazone 15 mg~Alogliptin 25 mg + Pioglitazone 30 mg~Alogliptin 25 mg + Pioglitazone 45 mg"
508071|NCT00328627|O2|Outcome|Alogliptin 12.5 + Pioglitazone|"Alogliptin 12.5 mg plus all active pioglitazone (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Alogliptin 12.5 mg + Pioglitazone 15 mg~Alogliptin 12.5 mg + Pioglitazone 30 mg~Alogliptin 12.5 mg + Pioglitazone 45 mg"
508072|NCT00328627|O1|Outcome|Pioglitazone Alone|"Alogliptin placebo plus all active pioglitazone groups (15, 30, and 45 mg).~This combination group includes participants from the following three treatment arms:~Placebo + Pioglitazone 15 mg~Placebo + Pioglitazone 30 mg~Placebo + Pioglitazone 45 mg"
508073|NCT00328627|E12|Reported Event|Alogliptin 25 + Pioglitazone 45|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508074|NCT00328627|E11|Reported Event|Alogliptin 12.5 + Pioglitazone 45|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508075|NCT00328627|E10|Reported Event|Placebo + Pioglitazone 45|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 45 mg, tablets, orally, once daily for up to 26 weeks.
508076|NCT00328627|E9|Reported Event|Alogliptin 25 + Pioglitazone 30|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508077|NCT00328627|E8|Reported Event|Alogliptin 12.5 + Pioglitazone 30|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508078|NCT00328627|E7|Reported Event|Placebo + Pioglitazone 30|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg, tablets, orally, once daily for up to 26 weeks.
508079|NCT00328627|E6|Reported Event|Alogliptin 25 + Pioglitazone 15|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508080|NCT00328627|E5|Reported Event|Alogliptin 12.5 + Pioglitazone 15|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508081|NCT00328627|E4|Reported Event|Placebo + Pioglitazone 15|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 15 mg, tablets, orally, once daily for up to 26 weeks.
508082|NCT00328627|E3|Reported Event|Alogliptin 25 + Placebo|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508083|NCT00328627|E2|Reported Event|Alogliptin 12.5 + Placebo|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508084|NCT00328627|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone placebo-matching tablets, orally, once daily for up to 26 weeks.
508085|NCT00328614|B7|Baseline|Total|Total of all reporting groups
508086|NCT00328614|B6|Baseline|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508087|NCT00328614|B5|Baseline|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508088|NCT00328614|B4|Baseline|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508089|NCT00328614|B3|Baseline|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508090|NCT00328614|B2|Baseline|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508091|NCT00328614|B1|Baseline|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508092|NCT00328614|P6|Participant Flow|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508093|NCT00328614|P5|Participant Flow|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508094|NCT00328614|P4|Participant Flow|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508095|NCT00328614|P3|Participant Flow|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508096|NCT00328614|P2|Participant Flow|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508097|NCT00328614|P1|Participant Flow|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508098|NCT00328614|O1|Outcome|Samarium-153|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508099|NCT00328614|E6|Reported Event|Samarium-153 (2.0 mCi/kg)|Cohort 6: Patients receive 2.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508100|NCT00328614|E5|Reported Event|Samarium-153 (1.5 mCi/kg)|Cohort 5: Patients receive 1.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508101|NCT00328614|E4|Reported Event|Samarium-153 (1.0 mCi/kg)|Cohort 4: Patients receive 1.0 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508102|NCT00328614|E3|Reported Event|Samarium-153 (0.75 mCi/kg)|Cohort 3: Patients receive 0.75 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508103|NCT00328614|E2|Reported Event|Samarium-153 (0.5 mCi/kg)|Cohort 2: Patients receive 0.5 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508104|NCT00328614|E1|Reported Event|Samarium-153 (0.25 mCi/kg)|Cohort 1: Patients receive 0.25 mCi/kg of Samarium-153, hormonal therapy, and radiation therapy
508105|NCT00328562|B1|Baseline|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508106|NCT00328562|P1|Participant Flow|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy"
508107|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508108|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508109|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508110|NCT00328562|O1|Outcome|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508111|NCT00328562|E1|Reported Event|Iressa and RT|"Iressa plus thoracic RT at the following dose levels:~Level 1: 42.0 Gy in 10 fractions of 4.2 Gy~Level 2: 50.4 Gy in 12 fractions of 4.2 Gy~Level 3: 63.0 Gy in 15 fractions of 4.2 Gy~ZD1839 (Iressa)~Thoracic Radiotherapy"
508112|NCT00328510|B3|Baseline|Total|Total of all reporting groups
508113|NCT00328510|B2|Baseline|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
508114|NCT00328510|B1|Baseline|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
508115|NCT00328510|P2|Participant Flow|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
508116|NCT00328510|P1|Participant Flow|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
508117|NCT00328510|O2|Outcome|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
508118|NCT00328510|O1|Outcome|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
508119|NCT00328510|E2|Reported Event|BrainLab Thermoplastic Mask|Participant undergoes SRT using the BrainLab thermoplastic mask to immobilize the participant's head during radiation therapy
508120|NCT00328510|E1|Reported Event|GTC Frame|Participant undergoes SRT using a GTC frame to immobilize the participant's heading during radiation therapy
508121|NCT00328263|B3|Baseline|Total|Total of all reporting groups
508122|NCT00328263|B2|Baseline|Placebo|98g/day of placebo (devoid of microorganisms)
508123|NCT00328263|B1|Baseline|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
508124|NCT00328263|P2|Participant Flow|Placebo|98g/day of placebo (devoid of microorganisms)
508125|NCT00328263|P1|Participant Flow|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
508126|NCT00328263|O2|Outcome|Placebo|98g/day of placebo (devoid of microorganisms)
508127|NCT00328263|O1|Outcome|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
508128|NCT00328263|E2|Reported Event|Placebo|98g/day of placebo (devoid of microorganisms)
508129|NCT00328263|E1|Reported Event|Bio-K+ CL1285|98g/day of Bio-K+ CL1285 containing 50 billion of live bacteria.
508130|NCT00328198|B1|Baseline|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508131|NCT00328198|P1|Participant Flow|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508132|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508133|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508134|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508135|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508136|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508137|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508138|NCT00328198|O1|Outcome|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508139|NCT00328198|E1|Reported Event|Alemtuzumab 30mg|Participants received a target dose of alemtuzumab 30mg by subcutaneous injection three times a week for up to 18 weeks. Some participants started in the Escalation subpopulation and started at a lower dose and escalated from 3mg to 10 mg to the target 30 mg dose in the first 1-2 weeks.
508140|NCT00328172|B6|Baseline|Total|Total of all reporting groups
508141|NCT00328172|B5|Baseline|Metformin|Patients randomized to receive treatment with metformin
508142|NCT00328172|B4|Baseline|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
508159|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
508160|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
508161|NCT00328172|O5|Outcome|Metformin|Patients randomized to receive treatment with metformin
508162|NCT00328172|O4|Outcome|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
508163|NCT00328172|O3|Outcome|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
508164|NCT00328172|O2|Outcome|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
508165|NCT00328172|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
508166|NCT00328172|E5|Reported Event|Metformin|Patients randomized to receive treatment with metformin
508167|NCT00328172|E4|Reported Event|Linagliptin (BI 1356) 5.0 mg|Patients randomized to receive treatment with linagliptin 5.0 mg
508168|NCT00328172|E3|Reported Event|Linagliptin (BI 1356) 2.5 mg|Patients randomized to receive treatment with linagliptin 2.5 mg
508169|NCT00328172|E2|Reported Event|Linagliptin (BI 1356) 0.5 mg|Patients randomized to receive treatment with linagliptin 0.5 mg
508170|NCT00328172|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
508171|NCT00328094|B3|Baseline|Total|Total of all reporting groups
508172|NCT00328094|B2|Baseline|Intermittent Insulin Bolus|Intermittent insulin boluses group
508173|NCT00328094|B1|Baseline|Continuous Insulin Infusion|Tight glucose group with insulin infusion
508174|NCT00328094|P2|Participant Flow|Intermittent Insulin Bolus|Intermittent insulin boluses group
508175|NCT00328094|P1|Participant Flow|Continuous Insulin Infusion|Tight glucose group with insulin infusion
508176|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
508177|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
508178|NCT00328094|O2|Outcome|Intermittent Insulin Bolus|Intermittent insulin boluses group
508179|NCT00328094|O1|Outcome|Continuous Insulin Infusion|Tight glucose group with insulin infusion
508180|NCT00328094|E2|Reported Event|Intermittent Insulin Bolus|Intermittent insulin boluses group
508181|NCT00328094|E1|Reported Event|Continuous Insulin Infusion|Tight glucose group with insulin infusion
508182|NCT00328042|B3|Baseline|Total|Total of all reporting groups
508183|NCT00328042|B2|Baseline|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
508184|NCT00328042|B1|Baseline|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
508185|NCT00328042|P2|Participant Flow|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
508186|NCT00328042|P1|Participant Flow|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
508187|NCT00328042|O2|Outcome|Information Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
508188|NCT00328042|O1|Outcome|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
508189|NCT00328042|O2|Outcome|Arm 2|Self-management self-study: This is an individual self-paced at home study program.
508190|NCT00328042|O1|Outcome|Arm 1|Self-Management Workshop: The workshop is a once per week 2.5 hour group that meets for six weeks.
508191|NCT00328042|E2|Reported Event|Information-Only|Information Only: This group receives a Hepatitis C Information Booklet and an HCV Resource Guide. The materials are designed for individual self-study.
508192|NCT00328042|E1|Reported Event|Self-Management Workshop|Self-Management Workshop: In addition to receiving HCV information materials to take home, the in-person 2.5 hour group workshop occurs weekly for six weeks.
508193|NCT00327717|B3|Baseline|Total|Total of all reporting groups
508194|NCT00327717|B2|Baseline|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508195|NCT00327717|B1|Baseline|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508196|NCT00327717|P2|Participant Flow|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508197|NCT00327717|P1|Participant Flow|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508198|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508199|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508200|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508201|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
509195|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
508202|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508203|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508204|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508205|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508206|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508207|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508208|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508209|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508210|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508211|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508212|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508213|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508214|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508215|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508216|NCT00327717|O2|Outcome|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508217|NCT00327717|O1|Outcome|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508218|NCT00327717|E2|Reported Event|Placebo|Patients in placebo group were titrated with placebo in the same way as in zonisamide group.
508219|NCT00327717|E1|Reported Event|Zonisamide 100 mg Tablet|Patients entered a 4-week titration period, during which zonisamide dosing began at 100 mg/day for the first 2 weeks, increased to 200 mg/day for the 3rd week, and to 300 mg/day for the 4th week, reaching 300 mg/d at the end of the titration period. 300 mg/d was the target dose in the titration period and must be reached. Dose increment was continued to 400 mg/d if this was tolerated by the patient.
508220|NCT00327470|B3|Baseline|Total|Total of all reporting groups
508221|NCT00327470|B2|Baseline|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508222|NCT00327470|B1|Baseline|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508223|NCT00327470|P2|Participant Flow|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508239|NCT00327470|E2|Reported Event|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508304|NCT00327171|E2|Reported Event|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508224|NCT00327470|P1|Participant Flow|Early Age-related Macular Degeneration (AMD)|Subjects with early choroidal neovascularization (CNV) lesions were distinguished from subjects with established CNV lesions based on the stage of evolution of their CNV as determined by fluorescein angiography and, where available, indocyanine green angiography as assessed by the investigator at Baseline. Subjects with early CNV lesions were treated in the study eye with Macugen (0.3 milligram [mg]) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508225|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508226|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508227|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508228|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508229|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508230|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508231|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508232|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508233|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508234|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508235|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508236|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508237|NCT00327470|O2|Outcome|Established AMD|Subjects with established CNV lesions (as assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508238|NCT00327470|O1|Outcome|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508268|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
508305|NCT00327171|E1|Reported Event|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508306|NCT00327015|B5|Baseline|Total|Total of all reporting groups
508240|NCT00327470|E1|Reported Event|Early AMD|Subjects with early CNV lesions (assessed by the investigator at Baseline) were treated in the study eye with Macugen (0.3 mg) every 6 weeks for 48 weeks. All subjects completing the first year of therapy (54 weeks [ie, 6 weeks after treatment at Week 48]) continued treatment in the second year of the study (Weeks 54 to 102), with Macugen (0.3 mg) administered every 12 weeks (ie, Weeks 60, 72, 84, and 96).
508241|NCT00327444|B3|Baseline|Total|Total of all reporting groups
508242|NCT00327444|B2|Baseline|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508243|NCT00327444|B1|Baseline|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508244|NCT00327444|P2|Participant Flow|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508245|NCT00327444|P1|Participant Flow|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508246|NCT00327444|O2|Outcome|Open-Label (OL) Period|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508247|NCT00327444|O1|Outcome|Double Blind (DB) Period|Participants with advanced ovarian cancer administered placebo or 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period.
508248|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508249|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508250|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508251|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508252|NCT00327444|O2|Outcome|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508253|NCT00327444|O1|Outcome|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508254|NCT00327444|E2|Reported Event|Aflibercept|Participants with advanced ovarian cancer administered 4.0 mg/kg aflibercept intravenously, once every two weeks in the DB period and the OL period.
508255|NCT00327444|E1|Reported Event|Placebo|Participants with advanced ovarian cancer administered placebo intravenously, once every two weeks in the DB period and 4.0 mg/kg aflibercept intravenously, once every two weeks in the OL period.
508256|NCT00327392|B1|Baseline|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
508257|NCT00327392|P1|Participant Flow|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
508258|NCT00327392|O1|Outcome|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
508259|NCT00327392|E1|Reported Event|Fospropofol Disodium|Fospropofol disodium 6.5 mg/kg (no less than 390 mg and no more than 585 mg, based on age, weight, and American Society of Anesthesiologists [ASA] Status): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 1.63 mg/kg (no less than 97.5 mg and no more than 146 mg) were administered as needed.
508260|NCT00327340|B3|Baseline|Total|Total of all reporting groups
508261|NCT00327340|B2|Baseline|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
508262|NCT00327340|B1|Baseline|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
508263|NCT00327340|P2|Participant Flow|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
508264|NCT00327340|P1|Participant Flow|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
508265|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
508266|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
508267|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
516745|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
508269|NCT00327340|O2|Outcome|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
508270|NCT00327340|O1|Outcome|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
508271|NCT00327340|O2|Outcome|OGX-011 + Docetaxel + Prednisone|custirsen (OGX-011) in combination with docetaxel and prednisone
508272|NCT00327340|O1|Outcome|OGX-011 + Mitoxantrone + Prednisone|custirsen (OGX-011) in combination with mitoxantrone and prednisone
508273|NCT00327340|E2|Reported Event|OGX-011 / Docetaxel/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and -3 of cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Docetaxel was infused at a dose of 75 mg/m² over 60 minutes on day 1 of each cycle.
508274|NCT00327340|E1|Reported Event|OGX-011 / Mitoxantrone/Prednisone|All subjects began with oral prednisone (5 mg twice daily)on Day-10. Custirsen (OGX-011) was infused intravenously over 2 hours on Day -7, -5 and-3 of cycle 1 (Pretreatment loading doses). OGX-011 was then infused for 2 hours on Days 1, 8, and 15 of each 21-day cycle. Mitoxantrone was infused at a dose of 12 mg/m² over 30 minutes on day 1 of each cycle.
508275|NCT00327171|B3|Baseline|Total|Total of all reporting groups
508276|NCT00327171|B2|Baseline|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508277|NCT00327171|B1|Baseline|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508278|NCT00327171|P2|Participant Flow|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508279|NCT00327171|P1|Participant Flow|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508280|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508281|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508282|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508283|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508284|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508285|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508286|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508287|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508288|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508289|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508290|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508291|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508292|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508293|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508294|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508295|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508296|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508297|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508298|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508299|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508300|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508301|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508302|NCT00327171|O2|Outcome|Aflibercept 4.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every two weeks
508303|NCT00327171|O1|Outcome|Aflibercept 2.0 mg/kg|Participants with advanced ovarian epithelial adenocarcinoma administered 2.0 mg/kg Aflibercept intravenously every two weeks
508781|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508307|NCT00327015|B4|Baseline|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508308|NCT00327015|B3|Baseline|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508309|NCT00327015|B2|Baseline|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508310|NCT00327015|B1|Baseline|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508311|NCT00327015|P4|Participant Flow|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508312|NCT00327015|P3|Participant Flow|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508313|NCT00327015|P2|Participant Flow|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508314|NCT00327015|P1|Participant Flow|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin Immediate Release (IR) was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508315|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508316|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508317|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508318|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508319|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508320|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508321|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508322|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508323|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508324|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508325|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508326|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508327|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508328|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508453|NCT00326898|E2|Reported Event|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508329|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508330|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508331|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508332|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508333|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508334|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508335|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508336|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508337|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508338|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508339|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508340|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508341|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508342|NCT00327015|O3|Outcome|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508343|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508344|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508345|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508346|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508347|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508348|NCT00327015|O3|Outcome|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508349|NCT00327015|O2|Outcome|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508350|NCT00327015|O1|Outcome|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508454|NCT00326898|E1|Reported Event|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508351|NCT00327015|E4|Reported Event|Saxagliptin 5 mg + Metformin|The Saxagliptin 5 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 5 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508352|NCT00327015|E3|Reported Event|Saxagliptin 10 mg + Metformin|The Saxagliptin 10 mg + Metformin group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose.
508353|NCT00327015|E2|Reported Event|Saxagliptin 10 mg|The Saxagliptin 10 mg group includes data from participants randomized to receive coadministration of blinded, fixed-dose saxagliptin 10 mg oral tablets and placebo resembling metformin.
508354|NCT00327015|E1|Reported Event|Metformin|The Metformin group includes data from participants randomized to receive coadministration of metformin IR 500 mg. Metformin IR was titrated, as tolerated, in increments of 500 mg up to a maximum of 2000 mg daily dose and placebo resembling saxagliptin.
508355|NCT00326963|B1|Baseline|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508356|NCT00326963|P1|Participant Flow|Enfuvirtide+PI+ARV’s|Eligible participants received Fuzeon® (enfuvirtide) 90 milligram (mg) subcutaneously (SC) two times a day (bid) for 24 weeks plus new protease inhibitor (PI) (darunavir/ritonavir) plus other investigator-choice antiretrovirals (ARVs). Participants selected their preferred injection device among the following three options: 27 gauge (G) ½” needle/syringe, 31G 8 millimeter (mm) needle/syringe or Biojector 2000 (B2000) needle-free injection device (NFID).
508357|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508358|NCT00326963|O1|Outcome|Enfuride+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508359|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508360|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508361|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508362|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508363|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508364|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508365|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508366|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508367|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508368|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508369|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508370|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508371|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508372|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508373|NCT00326963|O1|Outcome|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508374|NCT00326963|E1|Reported Event|Enfuvirtide+PI+ARV’s|Eligible participants received enfuvirtide 90 mg bid, SC injection for 24 weeks plus new PI (darunavir/ritonavir) plus other investigator-choice ARVs. Participants selected their preferred injection device among the following 3 options: 27G ½” needle/syringe, 31G 8 mm needle/syringe or B2000 NFID.
508375|NCT00326950|B1|Baseline|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
508376|NCT00326950|P1|Participant Flow|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
508377|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
508378|NCT00326950|O1|Outcome|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21 day cycle. The initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, 2.0 mg/m^2.
508379|NCT00326950|E1|Reported Event|E7389|E7389 will be administered intravenously on Days 1 and 8 of a 21-day cycle. Initial dose level will be 0.7 mg/m^2, with planned dose levels of 1.0, 1.4, & 2.0 mg/m^2.
508380|NCT00326911|B3|Baseline|Total|Total of all reporting groups
508381|NCT00326911|B2|Baseline|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508382|NCT00326911|B1|Baseline|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508383|NCT00326911|P2|Participant Flow|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508384|NCT00326911|P1|Participant Flow|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508385|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508386|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508387|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508388|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508389|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508542|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
508543|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|
508390|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508391|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508392|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508393|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508394|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508395|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508396|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508397|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508398|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508399|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508400|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508401|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508402|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508544|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|
516746|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
508403|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508404|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508405|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508406|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508407|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508408|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508409|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508410|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508411|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508412|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508413|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508414|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508415|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508635|NCT00326196|P2|Participant Flow|Coronary Artery Bypass Graft|Initial revascularization with Coronary artery bypass graft (CABG). Multiple arterial conduits for suitable target vessels will be encouraged in the surgical treatment.
508416|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508417|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508418|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508419|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508420|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508421|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508422|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508423|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508424|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508425|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508426|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508427|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508428|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508892|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508429|NCT00326911|O2|Outcome|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508430|NCT00326911|O1|Outcome|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508431|NCT00326911|E2|Reported Event|Cetuximab + Bevacizumab|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab and bevacizumab. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508432|NCT00326911|E1|Reported Event|Cetuximab + Bevacizumab + Gemcitabine|Cetuximab 400 mg/m2 weekly (over 120 minutes) on day 1 of cycle 1 with subsequent weekly infusions of 250 mg/m2 (over 60 minutes), followed by bevacizumab 10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks, and gemcitabine 1000 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks. Both medications will be administered by intravenous infusion on the same day. The order of study drug administration will be cetuximab, bevacizumab, and gemcitabine. On day 1 of cycle 1, one hour must elapse between administration of cetuximab and bevacizumab.
508433|NCT00326898|B4|Baseline|Total|Total of all reporting groups
508434|NCT00326898|B3|Baseline|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508435|NCT00326898|B2|Baseline|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508436|NCT00326898|B1|Baseline|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508437|NCT00326898|P3|Participant Flow|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508438|NCT00326898|P2|Participant Flow|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508439|NCT00326898|P1|Participant Flow|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508440|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508441|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508442|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508443|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508444|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508445|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508446|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508447|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508448|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508449|NCT00326898|O3|Outcome|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
508450|NCT00326898|O2|Outcome|Arm B (Sorafenib + Sunitinib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sorafenib tosylate 400mg PO QD or BID for 6 weeks and placebo sunitinib malate 37.5mg PO QD for 4 weeks followed.
508451|NCT00326898|O1|Outcome|Arm A (Sunitinib + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive sunitinib malate 37.5mg PO QD for 4 weeks and placebo sorafenib tosylate 400mg PO QD or BID for 6 weeks.
508452|NCT00326898|E3|Reported Event|Arm C (Sunitinib Placebo + Sorafenib Placebo)|Beginning 4-12 weeks following radical or partial nephrectomy, patients receive placebo sorafenib tosylate 400mg as in Arm A and placebo sunitinib malate 37.5mg as in Arm B.
516747|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
508455|NCT00326885|B1|Baseline|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508456|NCT00326885|P1|Participant Flow|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508457|NCT00326885|O1|Outcome|Full Analysis Set|
508458|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508459|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508460|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508461|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508462|NCT00326885|O1|Outcome|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508463|NCT00326885|E1|Reported Event|Catumaxomab|Each eligible patient will receive four ascending doses of catumaxomab, administered intraperitoneally via an indwelling catheter. Catumaxomab will be administered as a 3-hour constant rate infusion with a dosing interval of 4 days (10 μg, 20 μg, 50 μg, and 150 μg, respectively)
508464|NCT00326872|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508465|NCT00326872|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508466|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508467|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508468|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508469|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508470|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508471|NCT00326872|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508472|NCT00326872|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive 30 mg oral AZD2171 once daily on days 1-28. Treatment repeats every 28 days for 26 courses in the absence of disease progression or unacceptable toxicity. Patients with responding or stable disease may continue treatment beyond 26 courses in the absence of disease progression or unacceptable toxicity.
508473|NCT00326781|B3|Baseline|Total|Total of all reporting groups
508474|NCT00326781|B2|Baseline|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
508475|NCT00326781|B1|Baseline|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
508476|NCT00326781|P2|Participant Flow|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
508893|NCT00325442|E2|Reported Event|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508477|NCT00326781|P1|Participant Flow|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
508478|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
508479|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
508480|NCT00326781|O2|Outcome|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
508481|NCT00326781|O1|Outcome|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
508482|NCT00326781|E2|Reported Event|Nicotine Nasal Spray|Half of all participants received nicotine nasal spray. 8 weeks of self-administered nicotine nasal spray @ 40 recommended doses per day, tapering by 1/3 for the last 4 weeks. Nasal spray dosing was 0.5 mg spray per nostril (1 mg) for a maximum of 5 doses per hour and 40 doses per day. This dosing schedule is based on the average nicotine intake per cigarette of 1 mg per cigarette.
508483|NCT00326781|E1|Reported Event|Transdermal Nicotine|Half of randomized participants received 8-weeks of transdermal nicotine (Nicoderm CQ). The dosing schedule was as follows: 4 weeks of 21mg per 24 hours, 2 weeks of 14mg per 24 hours, and 2 weeks of 7mg per 24 hours.
508484|NCT00326716|B3|Baseline|Total|Total of all reporting groups
508485|NCT00326716|B2|Baseline|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508486|NCT00326716|B1|Baseline|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508487|NCT00326716|P4|Participant Flow|Infants ATV 400 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 400 mg / RTV 100 mg during the third trimester of pregnancy.
508488|NCT00326716|P3|Participant Flow|Infants ATV 300 mg / RTV 100 mg|Infants born to mothers receiving treatment with ATV 300 mg / RTV 100 mg during the third trimester of pregnancy.
508489|NCT00326716|P2|Participant Flow|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508490|NCT00326716|P1|Participant Flow|Mother ATV 300 mg / RTV 100 mg|Mothers receiving atazanavir (ATV) / ritonavir (RTV) 300/100 mg once daily (QD) + lamivudine (ZDV) / zidovudine (3TC) 300/150 mg twice daily (BID) during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508491|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508492|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508493|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508494|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508495|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508496|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508497|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508498|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508736|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
508499|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508500|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508501|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508502|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508503|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508504|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infansts of mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508505|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508506|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Infants born to mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508507|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID at the time of delivery. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508508|NCT00326716|O3|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508509|NCT00326716|O2|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508510|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508511|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508512|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508513|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508514|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508515|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508516|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508517|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508518|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508581|NCT00326599|B4|Baseline|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508519|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508520|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508521|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508522|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508523|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508524|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508525|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508526|NCT00326716|O3|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508527|NCT00326716|O2|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508528|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Second Trimester|Mothers receiving ATV/RTV 300/100 mg once daily (QD) + ZDV/3TC 300/150 mg twice daily (BID) during weeks 12 to 28 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508529|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508530|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508531|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508532|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508533|NCT00326716|O2|Outcome|Mothers ATV 400 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508534|NCT00326716|O1|Outcome|Mothers ATV 300 mg / 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508535|NCT00326716|O2|Outcome|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
508536|NCT00326716|O1|Outcome|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
508537|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508538|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508539|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
508540|NCT00326716|O1|Outcome|All Treated Mothers|Data are pooled for mothers in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
508541|NCT00326716|O2|Outcome|All Infants|Data are pooled for infants in the ATV 300 mg / RTV 100 mg and the ATV 400 mg / 100 mg groups.
508633|NCT00326196|B2|Baseline|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
508545|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508546|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508547|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508548|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508549|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508550|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg Third Trimester|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508551|NCT00326716|O2|Outcome|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508552|NCT00326716|O1|Outcome|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508553|NCT00326716|O2|Outcome|Mothers ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 36 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508554|NCT00326716|O1|Outcome|Mothers ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during weeks 28 to 38 of pregnancy. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508555|NCT00326716|E4|Reported Event|Mother ATV 400 mg / RTV 100 mg|Mothers receiving ATV/RTV 400/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508556|NCT00326716|E3|Reported Event|Mother ATV 300 mg / RTV 100 mg|Mothers receiving ATV/RTV 300/100 mg QD + ZDV/3TC 300/150 mg BID during the third trimester. Each dose of ATV/RTV (taken with a light meal or snack) was taken approximately 24 hours apart. Each dose of ZDV/3TC (taken with or without food) was taken approximately 12 hours apart.
508557|NCT00326716|E2|Reported Event|Infant ATV 400 mg / RTV 100 mg|Infants of mothers taking ATV 400 mg / RTV 100 mg at birth.
508558|NCT00326716|E1|Reported Event|Infant ATV 300 mg / RTV 100 mg|Infants of mothers taking ATV 300 mg / RTV 100 mg at birth.
508559|NCT00326612|B3|Baseline|Total|Total of all reporting groups
508560|NCT00326612|B2|Baseline|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508561|NCT00326612|B1|Baseline|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508562|NCT00326612|P2|Participant Flow|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508563|NCT00326612|P1|Participant Flow|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508564|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
508565|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
508566|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508567|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508568|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508569|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508570|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508571|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508572|NCT00326612|O2|Outcome|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508573|NCT00326612|O1|Outcome|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508574|NCT00326612|O2|Outcome|Rectal Diazepam|Includes intubation
508575|NCT00326612|O1|Outcome|Intranasal Midazolam|Patients who required oxygen at discharge from the Emergency Department
508576|NCT00326612|O2|Outcome|Rectal Diazepam|Median time to seizure cessation from medication administration to seizures stop time.
508577|NCT00326612|O1|Outcome|Intranasal Midazolam|Median time to seizure cessation from medication administration to seizures stop time.
508578|NCT00326612|E2|Reported Event|Rectal Diazepam|0.3-0.5 Rectal Diazepam for a seizure lasting longer than 5 minutes
508579|NCT00326612|E1|Reported Event|Intranasal Midazolam|0.2 mg/kg Intranasal Midazolam for a seizure longer than 5 minutes
508580|NCT00326599|B5|Baseline|Total|Total of all reporting groups
508634|NCT00326196|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous coronary intervention
508582|NCT00326599|B3|Baseline|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508583|NCT00326599|B2|Baseline|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508584|NCT00326599|B1|Baseline|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508585|NCT00326599|P4|Participant Flow|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508586|NCT00326599|P3|Participant Flow|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508587|NCT00326599|P2|Participant Flow|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508588|NCT00326599|P1|Participant Flow|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508589|NCT00326599|O1|Outcome|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508590|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508591|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508592|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508593|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508594|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508595|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508596|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508597|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508598|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508599|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508600|NCT00326599|O2|Outcome|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508601|NCT00326599|O1|Outcome|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508602|NCT00326599|E4|Reported Event|Phase II: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508603|NCT00326599|E3|Reported Event|Phase II: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 30mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508737|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
508604|NCT00326599|E2|Reported Event|Lead-in Phase: Arm II (Gemcitabine + Carboplatin)|Patients receive gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508605|NCT00326599|E1|Reported Event|Lead-in Phase: Arm I (Cediranib + Gemcitabine + Carboplatin)|Patients receive oral cediranib 45mg once daily in combination with chemotherapy, gemcitabine 1000 mg/m2 on days 1 and 8 and carboplatin dosed to an area under the serum concentration time curve of 5 on day 1 via intravenous infusion every 3 weeks for a maximum of six cycles.
508606|NCT00326495|B1|Baseline|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
508607|NCT00326495|P1|Participant Flow|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
508608|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
508609|NCT00326495|O1|Outcome|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
508610|NCT00326495|E1|Reported Event|BAY 43-9006 & Cetuximab|"BAY 43-9006: Administered orally at a dose of 400 mg twice a day (BID)~BAY 43-9006: is a potent inhibitor of proto-oncogene c-Raf (c-raf), and wild-type and mutant proto-oncogene b-Raf (b-raf) in vitro.~Cetuximab will be given intravenously (IV) at a dose of 400 mg/m^2 initially as a loading dose on week 2, followed by 250 mg/m^2 weekly starting on week 3.~Cetuximab is a recombinant human/mouse chimeric monoclonal antibody which binds specifically to the extracellular domain of the epidermal growth factor receptor (epidermal growth factor receptor (EGFR), human epidermal growth factor receptor 1 (HER1), c-ErbB) in normal and tumor cells, and competitively inhibits the binding of epidermal growth factor (EGF) and other ligands, such as transforming growth factor-alpha."
508611|NCT00326417|B3|Baseline|Total|Total of all reporting groups
508612|NCT00326417|B2|Baseline|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508613|NCT00326417|B1|Baseline|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508614|NCT00326417|P4|Participant Flow|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
508615|NCT00326417|P3|Participant Flow|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508616|NCT00326417|P2|Participant Flow|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508617|NCT00326417|P1|Participant Flow|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
508618|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508619|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508620|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508621|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508622|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508623|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508624|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508625|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508626|NCT00326417|O2|Outcome|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508627|NCT00326417|O1|Outcome|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508628|NCT00326417|E4|Reported Event|Fludarabine|Fludarabine only (no Cyclophosphamide administered)
508629|NCT00326417|E3|Reported Event|Cyclophosphamide 50mg|Fludarabine plus 50 mg/kg Cyclophosphamide (total dose)
508630|NCT00326417|E2|Reported Event|Cyclophosphamide 100mg|Fludarabine plus 100 mg/kg Cyclophosphamide (total dose)
508631|NCT00326417|E1|Reported Event|Cyclophosphamide 150mg|Fludarabine plus 150 mg/kg Cyclophosphamide (total dose)
508632|NCT00326196|B3|Baseline|Total|Total of all reporting groups
508636|NCT00326196|P1|Participant Flow|Percutaneous Coronary Intervention|"Initial revascularization with Percutaneous coronary intervention. Whenever possible, drug-eluting stents will be used in the percutaneous treatment. The use of multiple stents to achieve a complete revascularization will be encouraged in the PCI treatment"
508637|NCT00326196|O2|Outcome|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
508638|NCT00326196|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous coronary intervention
508639|NCT00326196|E2|Reported Event|Coronary Artery Bypass Graft|Coronary artery bypass graft (CABG)
508640|NCT00326196|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous coronary intervention
508641|NCT00326183|B3|Baseline|Total|Total of all reporting groups
508642|NCT00326183|B2|Baseline|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508643|NCT00326183|B1|Baseline|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508644|NCT00326183|P2|Participant Flow|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508645|NCT00326183|P1|Participant Flow|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508646|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508647|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508648|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508649|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508650|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508651|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508652|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508653|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508654|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508655|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508656|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508657|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508658|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508659|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508660|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508661|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508662|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508663|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508664|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508665|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508666|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508667|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508668|NCT00326183|O2|Outcome|Arm 2: VAQTA™ +ProQuad™|Hepatitis A vaccine, inactivated + measles, mumps, rubella, and varicella vaccine live
508669|NCT00326183|O1|Outcome|Arm 1: VAQTA™|Hepatitis A vaccine, inactivated
508670|NCT00326170|B1|Baseline|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
508671|NCT00326170|P1|Participant Flow|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
508672|NCT00326170|O1|Outcome|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
508673|NCT00326170|E1|Reported Event|VPA + 5-aza + ATRA|Daily for 7 days, Valproic acid (VPA) starting dose 75 mg/m^2 subcutaneously in combination with 5-azacytidine (5-aza) 50 mg/kg orally; and all-trans retinoic acid (ATRA) 45 mg/m^2 orally daily (in two divided doses) for 5 days starting on day 3.
508674|NCT00326118|B3|Baseline|Total|Total of all reporting groups
508675|NCT00326118|B2|Baseline|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508676|NCT00326118|B1|Baseline|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508677|NCT00326118|P2|Participant Flow|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508678|NCT00326118|P1|Participant Flow|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508738|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
508739|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
508679|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508680|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508681|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508682|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508683|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508684|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508685|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508686|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508687|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508688|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508689|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508690|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508691|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508692|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508693|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508694|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508695|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508696|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508697|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508698|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508740|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
508741|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
508742|NCT00325897|O1|Outcome|Azithromycin|Azithromycin, 250 mg
508743|NCT00325897|O2|Outcome|Placebo|Inactive sugar pill
508699|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508700|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508701|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm
508702|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508703|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508704|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508705|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508706|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508707|NCT00326118|O2|Outcome|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508708|NCT00326118|O1|Outcome|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508709|NCT00326118|E2|Reported Event|Meningitec + Hiberix Group|Subjects received a single dose of Meningitec™ vaccine co-administered with Hiberix™ and Priorix™ vaccines. The Meningitec vaccine was administered intramuscularly in the left deltoid region, the Hiberix vaccine was administered intramuscularly in the left thigh region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508710|NCT00326118|E1|Reported Event|Menitorix Group|Subjects received a single dose of Menitorix™ vaccine co-administered with Priorix™ vaccine. Menitorix vaccine was administered intramuscularly in the left deltoid region and the Priorix vaccine was administered subcutaneously in the right upper arm.
508711|NCT00326001|B3|Baseline|Total|Total of all reporting groups
508712|NCT00326001|B2|Baseline|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508713|NCT00326001|B1|Baseline|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508714|NCT00326001|P2|Participant Flow|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508715|NCT00326001|P1|Participant Flow|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508716|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508717|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508718|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508719|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508720|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508721|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508722|NCT00326001|O2|Outcome|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508723|NCT00326001|O1|Outcome|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508724|NCT00326001|E2|Reported Event|Pt-Ir Tip Catheter|Patients allocated to be ablated by 8-mm Platinum-Iridium tip catheter
508725|NCT00326001|E1|Reported Event|Gold Tip Catheter|Patients allocated to be ablated by 8-mm gold tip catheter
508726|NCT00325897|B3|Baseline|Total|Total of all reporting groups
508727|NCT00325897|B2|Baseline|Placebo|Inactive sugar pill
508728|NCT00325897|B1|Baseline|Azithromycin|Azithromycin, 250 mg
508729|NCT00325897|P2|Participant Flow|Placebo|Inactive sugar pill
508730|NCT00325897|P1|Participant Flow|Azithromycin|Azithromycin, 250 mg
508731|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
508732|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
508733|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
508734|NCT00325897|O1|Outcome|Azithromycin, 250 mg|"Macrolide Antibiotic (Azithromycin)~Macrolide Antibiotic (Azithromycin): Azithromycin (daily capsule, 250 mg for 12 months)"
508735|NCT00325897|O2|Outcome|Placebo|"Inactive~Placebo: Placebo taken on a daily basis"
508744|NCT00325897|O1|Outcome|Azithromycin|Azithromycin 250 mg
508750|NCT00325819|P2|Participant Flow|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
508751|NCT00325819|P1|Participant Flow|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
508752|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508753|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508754|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508755|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508756|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508757|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508758|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508759|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508760|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508761|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508762|NCT00325819|O2|Outcome|Placebo|Subjects who were randomized to receive placebo
508763|NCT00325819|O1|Outcome|Acetaminophen|Subjects who were randomized to receive acetaminophen
508764|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
508765|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
508766|NCT00325819|O2|Outcome|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
508767|NCT00325819|O1|Outcome|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
508768|NCT00325819|E2|Reported Event|Placebo|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination.
508769|NCT00325819|E1|Reported Event|Acetaminophen|Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. Children were to receive a maximum of five doses of the study medication and all doses were to be administered within 24 hours of vaccination. Parents were encouraged to take the bottle of study medication to the vaccination visit, and to give the first dose at that visit, after the child’s weight was assessed and within an hour before or after vaccination. Parents were instructed to give subsequent doses a minimum of four hours apart and to give the last dose of study medication no later than 24 hours after vaccination. Following the first dose, each subsequent dose was to be given no earlier than 4 hours following the previous dose. A maximum of five doses of study medication were to be given; the last dose no later than 24 hours after the study vaccination. Study drug was formulated to provide 160 mg of acetaminophen per 5 cc dose.
508770|NCT00325780|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
508771|NCT00325780|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
508772|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
508773|NCT00325780|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
508774|NCT00325780|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
508775|NCT00325754|B3|Baseline|Total|Total of all reporting groups
508776|NCT00325754|B2|Baseline|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508777|NCT00325754|B1|Baseline|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508778|NCT00325754|P2|Participant Flow|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508779|NCT00325754|P1|Participant Flow|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508780|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508782|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508783|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508784|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508785|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508786|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508787|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508788|NCT00325754|O2|Outcome|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508789|NCT00325754|O1|Outcome|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508790|NCT00325754|E2|Reported Event|Lightweight Cylinder|"3.6-lb lightweight cylinder that can be carried~Lightweight Cylinder: Ambulatory Oxygen Therapy Delivered Via A Carbon-Wrapped Aluminum Cylinder"
508791|NCT00325754|E1|Reported Event|E-Cylinder|"22-lb E-cylinder towed on a cart~E-Cylinder: Portable Oxygen Therapy Delivered Via An E-Cylinder Mounted On A Wheeled Cart"
508792|NCT00325598|B3|Baseline|Total|Total of all reporting groups
508793|NCT00325598|B2|Baseline|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
508794|NCT00325598|B1|Baseline|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
508795|NCT00325598|P2|Participant Flow|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
508796|NCT00325598|P1|Participant Flow|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
508797|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
508798|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
508799|NCT00325598|O2|Outcome|Cohort 2 (40 Gy)|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)"
508800|NCT00325598|O1|Outcome|Cohort 1 (36 Gy)|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)"
508801|NCT00325598|E4|Reported Event|Cohort 2 (40 Gy) Late Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
508802|NCT00325598|E3|Reported Event|Cohort 2 (40 Gy) Acute Toxicities|"40 Gy in 10 fractions BID over 5 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 91 through end of follow-up"
508803|NCT00325598|E2|Reported Event|Cohort 1 (36 Gy) Late Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
508804|NCT00325598|E1|Reported Event|Cohort 1 (36 Gy) Acute Toxicities|"36 Gy in 9 fractions BID x 4 1/2 treatment days~Partial Breast Irradiation (PBI)~Follow toxicities from Day 1 through Day 90"
508805|NCT00325468|B6|Baseline|Total|Total of all reporting groups
508806|NCT00325468|B5|Baseline|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508807|NCT00325468|B4|Baseline|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508808|NCT00325468|B3|Baseline|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508809|NCT00325468|B2|Baseline|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508810|NCT00325468|B1|Baseline|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508811|NCT00325468|P5|Participant Flow|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508812|NCT00325468|P4|Participant Flow|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508813|NCT00325468|P3|Participant Flow|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508814|NCT00325468|P2|Participant Flow|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508815|NCT00325468|P1|Participant Flow|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508840|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508816|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508817|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508818|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508819|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508820|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508821|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508822|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508823|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508824|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508825|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508826|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508827|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508828|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508829|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508830|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508831|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508832|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508833|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508834|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508835|NCT00325468|O1|Outcome|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508836|NCT00325468|O5|Outcome|Alendronate 70mg QW|In the parent study, this cohort received alendronate 70 mg orally (PO) QW for 2 years; treatment was discontinued for the remaining 2 years of parent Study 20010223. Treatment for 4 year in the current study represents initial exposure to denosumab in subjects previously treated with alendronate.
508837|NCT00325468|O4|Outcome|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508838|NCT00325468|O3|Outcome|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508839|NCT00325468|O2|Outcome|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508843|NCT00325468|E4|Reported Event|Denosumab Continuous Treatment|In the parent study 20010223, this cohort received denosumab SC for 4 years. During the first 2 years, the doses were 6 mg Q3M, 14 mg Q3M, 14 mg Q6M, 60 mg Q6M, or 100 mg Q6M. During the last two years, all subjects received 60 mg Q6M. Treatment for 4 years in the current study represents 8 years of continuous exposure to denosumab for this cohort.
508844|NCT00325468|E3|Reported Event|Denosumab 30 mg Q3M|In the parent study 20010223, this cohort received denosumab 30 mg SC Q3M for 2 years, placebo Q6M for 1 year, followed by denosumab 60 mg Q6M for 1 year. These subjects were treated with denosumab 60 mg Q6M for 4 years in the current study.
508845|NCT00325468|E2|Reported Event|Denosumab 210 mg Q6M|In the parent study 20010223, this cohort received denosumab 210 mg SC Q6M for 2 years and placebo Q6M for 2 years. These subjects were retreated with denosumab 60mg Q6M for 4 years in the current study.
508846|NCT00325468|E1|Reported Event|Placebo|In the parent study 20010223, this cohort received placebo SC for 4 years. Treatment for 4 years in the current study represents initial exposure to denosumab 60 mg Q6M.
508847|NCT00325442|B3|Baseline|Total|Total of all reporting groups
508848|NCT00325442|B2|Baseline|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508849|NCT00325442|B1|Baseline|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508850|NCT00325442|P2|Participant Flow|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508851|NCT00325442|P1|Participant Flow|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508852|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508853|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508854|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508855|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508856|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508857|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508858|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508859|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508860|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508861|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508862|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508863|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508864|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508865|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508866|NCT00325442|O3|Outcome|3.5 - 16 mg|Subjects in this group received 3.5 to 16 mg oral treprostinil twice daily.
508867|NCT00325442|O2|Outcome|1.25 - 3.25 mg|Subjects in this group recieved 1.25 to 3.25 mg oral treprostinil twice daily.
508868|NCT00325442|O1|Outcome|Less Than 1 mg or Discontinuation Due to Adverse Events|Subjects in this group received less than or equal to 1 mg oral treprostinil twice daily or discontinued treatment due to adverse events.
508869|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508870|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508871|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508872|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508873|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508874|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508875|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508876|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508877|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508878|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508879|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508880|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508881|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508882|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508883|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508884|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508885|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508886|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508887|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508888|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508889|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508890|NCT00325442|O1|Outcome|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508891|NCT00325442|O2|Outcome|Active|Subjects in this arm were randomly allocated to receive oral treprostinil twice daily.
508894|NCT00325442|E1|Reported Event|Placebo Arm|Subjects were randomly allocated to receive oral placebo twice daily.
508895|NCT00325416|B3|Baseline|Total|Total of all reporting groups
508896|NCT00325416|B2|Baseline|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508897|NCT00325416|B1|Baseline|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508898|NCT00325416|P2|Participant Flow|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508899|NCT00325416|P1|Participant Flow|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508900|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508901|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508902|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508903|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508904|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508905|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508906|NCT00325416|O2|Outcome|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508907|NCT00325416|O1|Outcome|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508908|NCT00325416|E2|Reported Event|Age Group B - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 61 years of age or older. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508909|NCT00325416|E1|Reported Event|Age Group A - Melphalan and Topotecan Plus Stem Cell Rescue|"Participants 18 – 60 years of age. Intensive-Dose Melphalan and Topotecan (MT) followed by Stem Cell transplant.~melphalan: (Days -4,-3,-2) 50 mg/m^2/day IV over 30 minutes (total dose 150 mg/m^2)~topotecan (TPT): Phase I Dose Escalation: Level 1 - 20 mg/m^2; Level 2 - 30 mg/m^2; Level 4 - 54 mg/m^2; Level 5 - 72 mg/m^2; Level 6 - 96 mg/m^2; Level 7 - 127.8 mg/m^2; Level 8 - 170.1 mg/m^2~Phase II: Treatment at maximum tolerated dose (MTD)~Autologous Stem Cell Rescue: Day 0"
508910|NCT00325403|B3|Baseline|Total|Total of all reporting groups
508911|NCT00325403|B2|Baseline|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population
508912|NCT00325403|B1|Baseline|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508913|NCT00325403|P2|Participant Flow|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
508914|NCT00325403|P1|Participant Flow|Placebo|These subjects were randomly allocated to receive matching oral placebo twice daily (every 12 hours +/- 1 hour) and were included in the primary analysis population. Dose increases were made in the absence of dose-limiting drug-related AEs, to ensure the subject received the optimal clinical dose throughout the study.
508915|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
508916|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
508917|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
508918|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
508919|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
508920|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
508921|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily.
508922|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily.
508923|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508924|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508925|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508926|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508927|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508928|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508929|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508930|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508931|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508932|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508933|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508934|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508935|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508936|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508937|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508938|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508939|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508940|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508941|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508942|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508943|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508944|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508945|NCT00325403|O2|Outcome|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508946|NCT00325403|O1|Outcome|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508947|NCT00325403|E2|Reported Event|UT-15C (Oral Treprostinil)|These subjects were randomly allocated to receive oral treprostinil twice daily and were included in the primary analysis population.
508948|NCT00325403|E1|Reported Event|Placebo|These subjects were randomly allocated to receive placebo twice daily and were included in the primary analysis population.
508949|NCT00325234|B3|Baseline|Total|Total of all reporting groups
508950|NCT00325234|B2|Baseline|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508951|NCT00325234|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508952|NCT00325234|P2|Participant Flow|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508953|NCT00325234|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508954|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508955|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508956|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508957|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508958|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508959|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508960|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508961|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508962|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508963|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508964|NCT00325234|O2|Outcome|Gemcitabine/Vinorelbine|Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8. Gemcitabine 1200 mg/m^2 will be given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days.
508965|NCT00325234|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0. The cycle of treatment was 21 days.
508966|NCT00325234|E2|Reported Event|Gemcitabine/Vinorelbine|"Vinorelbine 30 mg/m^2 was given over approximately 6-10 minutes on Day 1 and Day 8.~Gemcitabine 1200 mg/m^2 was given over approximately 30 minutes on Day 1 and Day 8 beginning after the end of the Vinorelbine infusion. The cycle of treatment was 21 days."
508967|NCT00325234|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed 600 mg/m^2 was administered intravenously over approximately 10 minutes on Day 1. Carboplatin was given over approximately 30 minutes on Day 1 beginning after the end of the Pemetrexed infusion, consistent with a target of AUC 5.0 mg*min/mL. The cycle of treatment was 21 days.
508968|NCT00325195|B4|Baseline|Total|Total of all reporting groups
508969|NCT00325195|B3|Baseline|Placebo|placebo infusion every 2 weeks
508970|NCT00325195|B2|Baseline|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508971|NCT00325195|B1|Baseline|q2 Wks|8 mg pegloticase every 2 weeks
508972|NCT00325195|P3|Participant Flow|Placebo|placebo infusion every 2 weeks
508973|NCT00325195|P2|Participant Flow|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508974|NCT00325195|P1|Participant Flow|q2 Wks|8 mg pegloticase every 2 weeks
508975|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
508976|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508977|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508979|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508980|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508981|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
508982|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508983|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508984|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
508985|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508986|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508987|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
508988|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508989|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508990|NCT00325195|O3|Outcome|Placebo|placebo infusion every 2 weeks
508991|NCT00325195|O2|Outcome|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508992|NCT00325195|O1|Outcome|q2 Wks|8 mg pegloticase every 2 weeks
508993|NCT00325195|E3|Reported Event|Placebo|placebo infusion every 2 weeks
508994|NCT00325195|E2|Reported Event|q4 Wks|8 mg pegloticase every 4 weeks (alternating with placebo infusion every 4 weeks)
508995|NCT00325195|E1|Reported Event|q2 Wks|8 mg pegloticase every 2 weeks
508996|NCT00325156|B1|Baseline|Infanrix-IPV+ Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
508997|NCT00325156|P1|Participant Flow|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
508998|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
508999|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
509000|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
509001|NCT00325156|O1|Outcome|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
509002|NCT00325156|E1|Reported Event|Infanrix-IPV+Hib Group|Healthy male or female subjects between and including 11 to 17 weeks of age at the time of first vaccination, who previously participated in a human rotavirus (HRV) study (444563/028), received 3 primary doses and one booster dose of Infanrix™-IPV/Hib vaccine at 3,4 and 5 months of age and 18 months of age, respectively, administered intramuscularly into the anterolateral thigh. Subjects also received 2 oral doses of Rotarix™ (HRV) vaccine or placebo, at 3 and 4 months of age.
509003|NCT00325143|B1|Baseline|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509004|NCT00325143|P1|Participant Flow|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509035|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509036|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509037|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
516748|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
509005|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509006|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509007|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509008|NCT00325143|O1|Outcome|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509009|NCT00325143|E1|Reported Event|Infanrix Hexa Group|Healthy male or female subjects between and including 11 to 17 weeks of age, who were previously vaccinated with Rotarix™ in study 444563/028, additionally received 2 doses of Infanrix™-IPV/Hib vaccine (at 3 and 4 months of age), 2 doses of Rotarix™ vaccine (at 2 and 4 months of age) and one dose of Infanrix Hexa™ vaccine (at 5 months of age) as a primary vaccination course, followed by administration of a booster dose of Infanrix™-IPV/Hib vaccine (at 18 months of age). The Infanrix™-IPV/Hib and Infanrix Hexa™ vaccines were administered intramuscularly into the right antero-lateral thigh, while the Rotarix™ vaccine was given orally.
509010|NCT00325130|B3|Baseline|Total|Total of all reporting groups
509011|NCT00325130|B2|Baseline|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509012|NCT00325130|B1|Baseline|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509013|NCT00325130|P2|Participant Flow|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509014|NCT00325130|P1|Participant Flow|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509015|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509016|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509017|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509018|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509019|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509020|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509021|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509022|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509023|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509024|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509025|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509026|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509027|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509028|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509029|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509030|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509031|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509032|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509033|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509034|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509187|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509038|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509039|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509040|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509041|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509042|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509043|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509044|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509045|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509046|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509047|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509048|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509049|NCT00325130|O2|Outcome|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509050|NCT00325130|O1|Outcome|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509051|NCT00325130|E2|Reported Event|Non-concomitant Administration|Non-concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509052|NCT00325130|E1|Reported Event|Concomitant Administration|Concomitant administration of quadrivalent HPV vaccine and Menactra™ and ADACEL™
509053|NCT00325078|B4|Baseline|Total|Total of all reporting groups
509054|NCT00325078|B3|Baseline|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
509055|NCT00325078|B2|Baseline|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
509056|NCT00325078|B1|Baseline|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
509057|NCT00325078|P3|Participant Flow|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
509058|NCT00325078|P2|Participant Flow|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
509059|NCT00325078|P1|Participant Flow|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
509060|NCT00325078|O2|Outcome|Observation|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
509061|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
509062|NCT00325078|O3|Outcome|Control Volunteers|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
509063|NCT00325078|O2|Outcome|Observation|Subjects with IBD without TNFa inhibitor treatment
509064|NCT00325078|O1|Outcome|Treatment|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
509065|NCT00325078|E3|Reported Event|Control Volunteer|Subjects who volunteer to participate in endoscopy and GI mucosal biopsies to provide controls for the study. The subjects in this arm may be healthy subjects, CGD subjects without GI symptoms, or subjects with Crohn’s disease (CD). The rate of infections in the CGD patients without IBD are monitored.
509066|NCT00325078|E2|Reported Event|Observation Group|CGD patients with IBD who are not treated with any study medication and are monitored for rate of infections.
516749|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
509067|NCT00325078|E1|Reported Event|Treatment Group|"This group comprises patients with Chronic granulomatous disease (CGD) complicated by significant inflammatory bowel disease (IBD). The subjects are treated with a TNFa inhibitor at standard recommended doses for treatment of Crohn’s disease. Infliximab is administered as intravenous infusions at 5mg/kg on weeks 0, 2 and 6 for induction and every 6-8 weeks at 5-10mg/kg for maintenance. Adalimumab is administered at 160mg, 60mg, 40mg, 40mg on weeks 0, 2, 4 and 6 via subcutaneous injection.~Endoscopies and gastrointestinal mucosal biopsies are obtained before treatment, following induction, and again at completion of treatment."
509068|NCT00325039|B3|Baseline|Total|Total of all reporting groups
509069|NCT00325039|B2|Baseline|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509070|NCT00325039|B1|Baseline|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509071|NCT00325039|P2|Participant Flow|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509072|NCT00325039|P1|Participant Flow|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509073|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509074|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509075|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509076|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509077|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509078|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509079|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509080|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509081|NCT00325039|O2|Outcome|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509082|NCT00325039|O1|Outcome|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509083|NCT00325039|E2|Reported Event|Transobturator (TMUS)|transobturator mid-urethral sling (TVT-O and the Monarc)
509084|NCT00325039|E1|Reported Event|Retropubic (RMUS)|retropubic mid-urethral sling (TVT)
509085|NCT00324961|B1|Baseline|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
509086|NCT00324961|P1|Participant Flow|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
509087|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
509088|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV|10 mg ADV tablets once daily for 104 weeks
509089|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509090|NCT00324961|O1|Outcome|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
509091|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509092|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509093|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509094|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509095|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509096|NCT00324961|O1|Outcome|HBeAg- at Baseline|All participants who were Hepatitis B e Antigen (HBeAg) negative at baseline
509097|NCT00324961|E1|Reported Event|10 mg Adefovir Dipivoxil (ADV)|10 mg ADV tablets once daily for 104 weeks
509098|NCT00324896|B3|Baseline|Total|Total of all reporting groups
509099|NCT00324896|B2|Baseline|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
509100|NCT00324896|B1|Baseline|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
509101|NCT00324896|P2|Participant Flow|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
509102|NCT00324896|P1|Participant Flow|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
509103|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
509104|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
509105|NCT00324896|O2|Outcome|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
509106|NCT00324896|O1|Outcome|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
509107|NCT00324896|E2|Reported Event|Placebo|Those randomly assigned to matching placebo, took their dose each night at bedtime
509108|NCT00324896|E1|Reported Event|Eszopiclone|"eszopiclone. Those under 65yo received 3mg of eszoplicone (or randomized to matching placebo)and those 65yo or older received 2mg of eszoplicone (or randomized to matching placebo)taken each night at bedtime~eszopiclone : eszopiclone"
509109|NCT00324870|B1|Baseline|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
509188|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509189|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509110|NCT00324870|P1|Participant Flow|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
509111|NCT00324870|O1|Outcome|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
509112|NCT00324870|E1|Reported Event|Arm I|"Phase I: Patients receive oral SAHA twice daily on days 1-14 and bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.~Cohorts of 3-6 patients receive escalating doses of SAHA until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. An additional 6 patients are treated at the MTD.~Phase II: Patients receive SAHA at the MTD determined in phase I and bevacizumab as in phase I.~vorinostat: Given orally~bevacizumab: Given IV"
509113|NCT00324857|B5|Baseline|Total|Total of all reporting groups
509114|NCT00324857|B4|Baseline|Arm 4/ DA and MI|Decision aid and MI
509115|NCT00324857|B3|Baseline|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
509116|NCT00324857|B2|Baseline|Arm 2/Decision Aid (DA)|Decision Aid video
509117|NCT00324857|B1|Baseline|Arm 1/Attention Control|Attention control
509118|NCT00324857|P4|Participant Flow|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
509119|NCT00324857|P3|Participant Flow|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
509120|NCT00324857|P2|Participant Flow|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
509121|NCT00324857|P1|Participant Flow|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
509122|NCT00324857|O4|Outcome|Arm 4/ DA and MI|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option.~Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain"
509123|NCT00324857|O3|Outcome|Arm 3/ Motivational Interview (MI)|Motivational Interviewing: The research intervention will conduct the fact-to-face MI session with the participant. This was used as a mechanism to help patients confront their thoughts about TKR and how to engage their primary care doctors about knee pain
509124|NCT00324857|O2|Outcome|Arm 2/Decision Aid (DA)|"Decision Aid Video: The research interventionist will show the participant the Dartmouth Knee OA Decision Aid video entitled Treatment Choices for Knee Osteoarthritis. The video gives a detailed explanation of 1) the damage to the knee joint caused by OA; 2) treatment options including lifestyle changes, medications, injections, complementary therapy, and surgery; 3) the risks, benefits, and known efficacy of each treatment option."
509125|NCT00324857|O1|Outcome|Arm 1/Attention Control|Subjects randomized to the attention control arm received a patient educational booklet about OA published by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. This booklet provides a brief educational program that summarizes how to live with knee OA but does not specifically mention joint replacement
509126|NCT00324857|E4|Reported Event|Arm 4/ DA and MI|Decision Aid and MI
509127|NCT00324857|E3|Reported Event|Arm 3/ Motivational Interview (MI)|Motivational Interviewing
509128|NCT00324857|E2|Reported Event|Arm 2/Decision Aid (DA)|Decision Aid
509129|NCT00324857|E1|Reported Event|Arm 1/Attention Control|Attention Control
509130|NCT00324740|B1|Baseline|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509131|NCT00324740|P3|Participant Flow|Dose Level 3: Vorinostat (300mg) and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.5 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509190|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509132|NCT00324740|P2|Participant Flow|Dose Level 2 Vorinostat (300mg) and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.375 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509133|NCT00324740|P1|Participant Flow|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA-300 mg) twice daily and oral isotretinoin (0.25 mg/kg) twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509134|NCT00324740|O1|Outcome|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509135|NCT00324740|O3|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.5 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509136|NCT00324740|O2|Outcome|Dose Level 2 Vorinostat (300mg)and Isotretinoin (0.375 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509137|NCT00324740|O1|Outcome|Dose Level 1: Vorinostat (300mg) and Isotretinoin (0.25 mg/kg)|"Patients receive oral vorinostat (SAHA) and oral isotretinoin twice daily for 3 consecutive days per week (Tues/Wed/Thurs). Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509138|NCT00324740|E1|Reported Event|Treatment (Vorinostat and Isotretinoin)|"Patients receive oral vorinostat (SAHA) twice daily and oral isotretinoin twice daily on days 3-5, 10-12, 17-19, and 24-26. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.~vorinostat: Given orally~isotretinoin: Given orally"
509139|NCT00324701|B3|Baseline|Total|Total of all reporting groups
509140|NCT00324701|B2|Baseline|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
509141|NCT00324701|B1|Baseline|Telepsychology|therapy done at patients house using in-home video conferencing technology
509142|NCT00324701|P2|Participant Flow|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
509143|NCT00324701|P1|Participant Flow|Telepsychology|therapy done at patients house using in-home video conferencing technology
509144|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
509145|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
509146|NCT00324701|O2|Outcome|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
509147|NCT00324701|O1|Outcome|Telepsychology|therapy done at patients house using in-home video conferencing technology
509148|NCT00324701|E2|Reported Event|Face-to-face Therapy|therapy delivered at the VAMC in the same room as the therapist
509149|NCT00324701|E1|Reported Event|Telepsychology|therapy done at patients house using in-home video conferencing technology
509150|NCT00324675|B3|Baseline|Total|Total of all reporting groups
509151|NCT00324675|B2|Baseline|Placebo|
509152|NCT00324675|B1|Baseline|Rosiglitazone|
509153|NCT00324675|P2|Participant Flow|Placebo|
509154|NCT00324675|P1|Participant Flow|Rosiglitazone|
509155|NCT00324675|O2|Outcome|Placebo|
509156|NCT00324675|O1|Outcome|Rosiglitazone|
509157|NCT00324675|E2|Reported Event|Placebo|
509158|NCT00324675|E1|Reported Event|Rosiglitazone|
509159|NCT00324649|B3|Baseline|Total|Total of all reporting groups
509160|NCT00324649|B2|Baseline|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509161|NCT00324649|B1|Baseline|Truvada|Truvada + NNRTI or PI.
509162|NCT00324649|P2|Participant Flow|Zidovudine/Lamivudine|Zidovudine/lamivudine + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
509163|NCT00324649|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
509164|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509165|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509166|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509167|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509168|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509169|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509170|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509171|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509172|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509173|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509174|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509175|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509176|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509177|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509178|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509179|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509180|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509181|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509182|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509183|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509184|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509185|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509186|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509196|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509197|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509198|NCT00324649|O2|Outcome|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509199|NCT00324649|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509200|NCT00324649|E2|Reported Event|Zidovudine/Lamivudine|Zidovudine/lamivudine + NNRTI or PI.
509201|NCT00324649|E1|Reported Event|Truvada|Truvada + NNRTI or PI.
509202|NCT00324415|B1|Baseline|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509203|NCT00324415|P1|Participant Flow|Combined Modality Therapy|Combined modality therapy consists of cisplatin, 5-flourouracil, and irradiation plus cetuximab
509204|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509205|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509206|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509207|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509208|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509209|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509210|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509211|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509212|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509213|NCT00324415|O1|Outcome|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab.
509214|NCT00324415|E1|Reported Event|Combined Modality Therapy|cisplatin, 5-flourouruacil, and irradiation plus cetuximab
509215|NCT00324350|B3|Baseline|Total|Total of all reporting groups
509216|NCT00324350|B2|Baseline|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509217|NCT00324350|B1|Baseline|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509218|NCT00324350|P2|Participant Flow|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509219|NCT00324350|P1|Participant Flow|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509220|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509221|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509222|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509223|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%) in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509224|NCT00324350|O2|Outcome|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509225|NCT00324350|O1|Outcome|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509226|NCT00324350|E2|Reported Event|Standard Glycemic Control|standard strategy targeting A1C levels from 7.0 to 7.9% in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509227|NCT00324350|E1|Reported Event|Intensive Glycemic Control|intensive therapeutic strategy targeting normal glycated hemoglobin (A1C) levels (i.e., below 6.0%)in a population with long-standing type 2 diabetes and a history of cardiovascular disease or significant cardiovascular risk factors
509228|NCT00324272|B5|Baseline|Total|Total of all reporting groups
509229|NCT00324272|B4|Baseline|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509230|NCT00324272|B3|Baseline|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509464|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509231|NCT00324272|B2|Baseline|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509232|NCT00324272|B1|Baseline|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509233|NCT00324272|P4|Participant Flow|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509234|NCT00324272|P3|Participant Flow|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509235|NCT00324272|P2|Participant Flow|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509236|NCT00324272|P1|Participant Flow|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509237|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509238|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509239|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509240|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509241|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509593|NCT00321737|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509242|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509243|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509244|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509245|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509246|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509247|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509248|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509249|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509250|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509251|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509252|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509253|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509254|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509255|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509256|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509257|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509258|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509259|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509260|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509261|NCT00324272|O4|Outcome|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509262|NCT00324272|O3|Outcome|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509263|NCT00324272|O2|Outcome|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509465|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509264|NCT00324272|O1|Outcome|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509265|NCT00324272|E4|Reported Event|Axillary Dissection: no Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509266|NCT00324272|E3|Reported Event|Axillary Dissection: Sealant Used.|A level I to III nodal clearance was performed in axillary dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509267|NCT00324272|E2|Reported Event|Groin Dissection: no Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. No Tisseel fibrin sealant was instilled into the wound. The skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509268|NCT00324272|E1|Reported Event|Groin Dissection: Sealant Used.|All infrainguinal nodes, including Cloquet’s node, were removed in all groin dissection cases. Routine peri-operative antibiotic prophylaxis was used. Diathermy and ligating clips were used as required and the wound bed irrigated with sterile water prior to closure. Closed suction drains were inserted and secured with drain sutures. 4 ml of Tisseel fibrin sealant (containing 1000 IU of human thrombin as the ‘fast-set’ preparation) were instilled into the wound using the Duploject™ spray delivery system. Firm pressure was applied to the wound for three minutes whilst the sealant set in order to obliterate the dead space, following which the skin was closed in two layers using absorbable sutures and the drains were vacuumed. A dry dressing was applied.
509269|NCT00324259|B3|Baseline|Total|Total of all reporting groups
509270|NCT00324259|B2|Baseline|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509271|NCT00324259|B1|Baseline|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509272|NCT00324259|P2|Participant Flow|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509273|NCT00324259|P1|Participant Flow|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509274|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol) and Arm 2 (30 mg Estradiol)|"Arm 1 = 6 mg of estradiol daily (2 mg tid).~Arm 2 = 30 mg of estradiol. (10 mg tid)"
509275|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509276|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509277|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509278|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509279|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509280|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509281|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509282|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509283|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509284|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509285|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509286|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509287|NCT00324259|O2|Outcome|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509288|NCT00324259|O1|Outcome|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509289|NCT00324259|E2|Reported Event|Arm 2 (30 mg Estradiol)|30 mg of estradiol. (10 mg tid)
509290|NCT00324259|E1|Reported Event|Arm 1 (6 mg Estradiol)|6 mg of estradiol daily (2 mg tid).
509291|NCT00324233|B3|Baseline|Total|Total of all reporting groups
509292|NCT00324233|B2|Baseline|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
509293|NCT00324233|B1|Baseline|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
509294|NCT00324233|P2|Participant Flow|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
509295|NCT00324233|P1|Participant Flow|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
509296|NCT00324233|O2|Outcome|SpediCath Compact Male|
509297|NCT00324233|O1|Outcome|SpeediCath|
509298|NCT00324233|E2|Reported Event|SCCM Then SC|SpeediCath Compact Male (SCCM)catheter in the first period then SpeediCath(SC)catheter in second period
509299|NCT00324233|E1|Reported Event|SC Then SCCM|SpeediCath (SC)catheter in first period then SpeediCath Compact Male (SCCM)catheter in second period
509300|NCT00324168|B3|Baseline|Total|Total of all reporting groups
509301|NCT00324168|B2|Baseline|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509302|NCT00324168|B1|Baseline|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509303|NCT00324168|P2|Participant Flow|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509304|NCT00324168|P1|Participant Flow|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, then twice a day for 1 week, and finally once a day for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509305|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509306|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509307|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509308|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509309|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509310|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509311|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509312|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509313|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509314|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509315|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509316|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509317|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509318|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509319|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509320|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509321|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509322|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509323|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509324|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509325|NCT00324168|O2|Outcome|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509326|NCT00324168|O1|Outcome|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509780|NCT00323609|P2|Participant Flow|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509327|NCT00324168|E2|Reported Event|Placebo|"Placebo : 0.9% NaCl and preservative (same as in steroid) four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509328|NCT00324168|E1|Reported Event|Steroid|"Topical corticosteroid : prednisolone phosphate 1% with preservative four times a day for 1 week, BID for 1 week, QD for 1 week~Antibiotics : moxifloxacin 0.5% every one hour for 48 hours while awake and then every 2 hours until re-epithelialization"
509329|NCT00324155|B3|Baseline|Total|Total of all reporting groups
509330|NCT00324155|B2|Baseline|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509331|NCT00324155|B1|Baseline|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509332|NCT00324155|P2|Participant Flow|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509333|NCT00324155|P1|Participant Flow|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509334|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509335|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509336|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509337|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509338|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509339|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10m g/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509340|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509341|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509466|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
516750|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
509342|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
509343|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509344|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509345|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In maintenance phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509346|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; one dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509347|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression, (PD) unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509348|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509349|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509350|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent."
509351|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1e dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509352|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509353|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509354|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
509355|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 weeks will be continued until disease progression. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509467|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
516751|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
509356|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509357|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509358|NCT00324155|O2|Outcome|Placebo and Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until PD, unacceptable toxicity, or withdrawal of consent~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent"
509359|NCT00324155|O1|Outcome|Ipilimumab and Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10 mg/kg, every 12 weeks will be continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase."
509360|NCT00324155|E2|Reported Event|Placebo + Dacarbazine|"Placebo: Intravenous solution; intravenous; 0 mg; 1 dose every 3 weeks for 10 weeks then 1 dose every 12 weeks starting at Week 24; until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509361|NCT00324155|E1|Reported Event|10 mg/kg Ipilimumab + Dacarbazine|"Ipilimumab: Intravenous solution; intravenous; 10 mg/kg; 1 dose every 3 weeks for 10 weeks, then 1 dose every 12 weeks starting at Week 24, until disease progression (PD), unacceptable toxicity, or withdrawal of consent.~Dacarbazine: Intravenous solution; intravenous; 850 mg/m^2; 1 dose every 3 weeks for 22 weeks, until PD, unacceptable toxicity, or withdrawal of consent.~In Maintenance Phase: Only Ipilimumab: 10mg/kg, every 12 wks was continued until PD. Dacarbazine was given up to Week 22 and was not given in the Maintenance Phase. Participants who experienced PD or who did not wish to continue study assessments in the Induction or Maintenance Phases entered the Follow-up Phase."
509362|NCT00324116|B1|Baseline|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509363|NCT00324116|P1|Participant Flow|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509364|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509365|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509366|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509367|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509368|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509369|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509370|NCT00324116|O1|Outcome|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509371|NCT00324116|E1|Reported Event|Pegaptanib Sodium|All subjects received a 0.3 mg/eye pegaptanib sodium intravitreous injection every 6 weeks for 54 weeks.
509372|NCT00324038|B3|Baseline|Total|Total of all reporting groups
509373|NCT00324038|B2|Baseline|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
509374|NCT00324038|B1|Baseline|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
509375|NCT00324038|P2|Participant Flow|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
509376|NCT00324038|P1|Participant Flow|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
509377|NCT00324038|O2|Outcome|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
509378|NCT00324038|O1|Outcome|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
509379|NCT00324038|E2|Reported Event|Co-codamol Tablets|combination tablet of codeine and paracetamol taken orally 3 or 4 times daily. Dosage form ranges from 8/500, 15/500 and 30/500
509380|NCT00324038|E1|Reported Event|Buprenorphine Transdermal System|Buprenorphine transdermal system (patch)5mg, 10mg & 20mg worn for 7 days
509381|NCT00323882|B6|Baseline|Total|Total of all reporting groups
509468|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509469|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509470|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509382|NCT00323882|B5|Baseline|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509383|NCT00323882|B4|Baseline|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509384|NCT00323882|B3|Baseline|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509385|NCT00323882|B2|Baseline|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509386|NCT00323882|B1|Baseline|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509387|NCT00323882|P5|Participant Flow|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509388|NCT00323882|P4|Participant Flow|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to Response Evaluation Criteria in Solid Tumors (RECIST), target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509389|NCT00323882|P3|Participant Flow|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509390|NCT00323882|P2|Participant Flow|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses (maintenance). The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509391|NCT00323882|P1|Participant Flow|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes intravenously (IV) on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of stable disease (SD) or conflicting disease response assessment (CDRA) at the end of the induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509471|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509594|NCT00321737|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509392|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509393|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509394|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509395|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509396|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509397|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509398|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509399|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509400|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509401|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509472|NCT00323869|E1|Reported Event|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509473|NCT00321789|B3|Baseline|Total|Total of all reporting groups
509474|NCT00321789|B2|Baseline|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
516752|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
509402|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509403|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509404|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509405|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509406|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509407|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509408|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509409|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509410|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509411|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509412|NCT00323882|O6|Outcome|All Treated Participants|All treatment groups are combined to show total overall survival at completion of Follow Up.
509524|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509595|NCT00321737|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509413|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509414|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509415|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509416|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509417|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509418|NCT00323882|O6|Outcome|All Treated Participants|All participants in all treatment arms combined.
509419|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509420|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509421|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509422|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509423|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509475|NCT00321789|B1|Baseline|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509424|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509425|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509426|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509427|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509428|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509429|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants with no prior chemotherapy, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509430|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509431|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509432|NCT00323882|O3|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|In those participants who had received no chemotherapy prior to the study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509476|NCT00321789|P2|Participant Flow|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509525|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509433|NCT00323882|O2|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|In those who received chemotherapy prior to enrolling in this study, a single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509434|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509435|NCT00323882|O6|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Chemotherapy Naive)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509436|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination (Prior Chemotherapy)|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509437|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509438|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509439|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509440|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509441|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509477|NCT00321789|P1|Participant Flow|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509596|NCT00321711|B6|Baseline|Total|Total of all reporting groups
509442|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509443|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509444|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509445|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509446|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509447|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509448|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509449|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509450|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509451|NCT00323882|O5|Outcome|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509478|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509526|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509630|NCT00321711|E2|Reported Event|Part A Romiplostim 500 µg|
509452|NCT00323882|O4|Outcome|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509453|NCT00323882|O3|Outcome|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509454|NCT00323882|O2|Outcome|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509455|NCT00323882|O1|Outcome|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509456|NCT00323882|E5|Reported Event|Ipilimumab 10 mg/kg + XRT Combination|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal XRT to each target lesion within 48 hours before the first infusion of ipilimumab in the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral CT. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509457|NCT00323882|E4|Reported Event|Ipilimumab 3 mg/kg + XRT Combination Therapy|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. In addition, participants received a single dose of 800 rads (8 Gray) of focal radiotherapy (XRT) to each target lesion within 48 hours before the first infusion of ipilimumab during the induction period. According to RECIST, target or measurable lesions were defined as lesions that could be accurately measured in at least one dimension (longest diameter recorded) as ≥ 10 mm with spiral computed tomography (CT). Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total 16 doses in the maintenance period. Radiotherapy was not administered during maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509458|NCT00323882|E3|Reported Event|Ipilimumab Monotherapy 10 mg/kg|A single dose of 10 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509459|NCT00323882|E2|Reported Event|Ipilimumab Monotherapy 5 mg/kg|A single dose of 5 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses (induction). Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509460|NCT00323882|E1|Reported Event|Ipilimumab Monotherapy 3 mg/kg|A single dose of 3 mg/kg ipilimumab was administered over 90 minutes IV on Days 1, 22, 43, and 64 for a total of 4 doses in the induction period. Those participants with a clinical response of SD or CDRA at the end of induction period could have received additional treatment up to a total of 16 doses in the maintenance period. The length of time on study for an individual could be up to 2 years. Follow up for survival status was for up to 5 years after enrollment.
509461|NCT00323869|B1|Baseline|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509462|NCT00323869|P1|Participant Flow|Bevacizumab + Carboplatin + Gemcitabine|"Bevacizumab in combination with carboplatin and gemcitabine~Bevacizumab was administered 15 mg/kg IV on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles in combination with chemotherapy, then continuing until evidence of progressive disease or significant treatment-related toxicity Gemcitabine, administered 1000 mg/m2 IV on days 1 and 8 of each 3-week cycle (twice per cycle) for up to 6 cycles Carboplatin, administered IV at area under the curve (AUC) of 5, every 3 weeks on day 1 of each 3-week cycle (once per cycle) for up to 6 cycles~Carboplatin was administered before gemcitabine infusion.~Bevacizumab was administered 1 hour after end of all chemotherapy infusions.~Bevacizumab: Murine humanized anti-vascular endothelial growth factor A (VEGF-A) monoclonal antibody~Gemcitabine: Nucleoside analog~Carboplatin: Alkylating agent"
509463|NCT00323869|O1|Outcome|Bevacizumab + Carboplatin + Gemcitabine|"Treatment provided in 3-week cycles:~15 mg/kg bevacizumab Day 1 of each cycle~1000 mg/m2 gemcitabine Days 1 and 8 of each cycle~Carboplatin (AUC of 5 every 3 weeks)"
509588|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509479|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509480|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509481|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509482|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509483|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509484|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509485|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509486|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509487|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509488|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509489|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509490|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509491|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509492|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509493|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509494|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509495|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509496|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509497|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509498|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509523|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509631|NCT00321711|E1|Reported Event|Part A Placebo|
509499|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509500|NCT00321789|O2|Outcome|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509501|NCT00321789|O1|Outcome|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509502|NCT00321789|E2|Reported Event|Usual Care|Couples assigned to usual care received educational materials at baseline and usual care to the patient thereafter, with no contact from the study interventionist.
509503|NCT00321789|E1|Reported Event|Intervention|Couples enrolled in the intervention arm received educational materials at baseline, followed by eight monthly phone calls from a study nurse. Each month, the patient participant created goals and action plans related to diet, exercise, patient-provider communication, or medication adherence. Following the patient call, the spouse participant was informed of the patient's goals and action plans developed a support plan to help the patient achieve his or her goal.
509504|NCT00321763|B5|Baseline|Total|Total of all reporting groups
509505|NCT00321763|B4|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509506|NCT00321763|B3|Baseline|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509507|NCT00321763|B2|Baseline|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509508|NCT00321763|B1|Baseline|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509509|NCT00321763|P4|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509510|NCT00321763|P3|Participant Flow|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509511|NCT00321763|P2|Participant Flow|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509512|NCT00321763|P1|Participant Flow|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509513|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509514|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509515|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509516|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509517|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509518|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509519|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509520|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509521|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509522|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509589|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509590|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509527|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509528|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509529|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509530|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509531|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509532|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509533|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509534|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509535|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509536|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509537|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509538|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509539|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509540|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509541|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509542|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509543|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509544|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509545|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509546|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509547|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509548|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509549|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509550|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509551|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509591|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509592|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509552|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509553|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509554|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509555|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509556|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509557|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509558|NCT00321763|O5|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509559|NCT00321763|O4|Outcome|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509560|NCT00321763|O3|Outcome|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509561|NCT00321763|O2|Outcome|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509562|NCT00321763|O1|Outcome|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509563|NCT00321763|E5|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509564|NCT00321763|E4|Reported Event|GSK1247446A Pooled Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
509565|NCT00321763|E3|Reported Event|GSK1247446A Lot 3 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509566|NCT00321763|E2|Reported Event|GSK1247446A Lot 2 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509567|NCT00321763|E1|Reported Event|GSK1247446A Lot 1 Group|Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
509568|NCT00321737|B4|Baseline|Total|Total of all reporting groups
509569|NCT00321737|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509570|NCT00321737|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509571|NCT00321737|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509572|NCT00321737|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509573|NCT00321737|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509574|NCT00321737|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509575|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509576|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509577|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509578|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509579|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509580|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509581|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509582|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509583|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509584|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509585|NCT00321737|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 6 months.
509586|NCT00321737|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
509587|NCT00321737|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
509632|NCT00321698|B6|Baseline|Total|Total of all reporting groups
509597|NCT00321711|B5|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509598|NCT00321711|B4|Baseline|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509599|NCT00321711|B3|Baseline|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509600|NCT00321711|B2|Baseline|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509601|NCT00321711|B1|Baseline|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509602|NCT00321711|P5|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509603|NCT00321711|P4|Participant Flow|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509604|NCT00321711|P3|Participant Flow|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509605|NCT00321711|P2|Participant Flow|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509606|NCT00321711|P1|Participant Flow|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509607|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509608|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509609|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509610|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509611|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509612|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509613|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509614|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509615|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509616|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509617|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509618|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509619|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509620|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509621|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509622|NCT00321711|O5|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Decitabine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509623|NCT00321711|O4|Outcome|Romiplostim (AMG 531) Placebo Plus Decitabine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 20 mg/m^2 decitabine daily for 5 days during each of four 28-day cycles (Part B)
509624|NCT00321711|O3|Outcome|Romiplostim (AMG 531) 750 Mcg Plus Azacitidine|750 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509625|NCT00321711|O2|Outcome|Romiplostim (AMG 531) 500 Mcg Plus Azacitidine|500 mcg romiplostim (AMG 531) weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509626|NCT00321711|O1|Outcome|Romiplostim (AMG 531) Placebo Plus Azacitidine|Romiplostim (AMG 531) placebo weekly via subcutaneous injection plus 75 mg/m^2 azacitidine daily for 7 days during each of four 28-day cycles (Part A)
509627|NCT00321711|E5|Reported Event|Part B Romiplostim 750 µg|
509628|NCT00321711|E4|Reported Event|Part B Placebo|
509629|NCT00321711|E3|Reported Event|Part A Romiplostim 750 µg|
509633|NCT00321698|B5|Baseline|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509634|NCT00321698|B4|Baseline|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509635|NCT00321698|B3|Baseline|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509636|NCT00321698|B2|Baseline|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509637|NCT00321698|B1|Baseline|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509638|NCT00321698|P5|Participant Flow|Phase II, MTD Dose|"MTD=Docetaxel IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation plus external beam radiation, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions).~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509639|NCT00321698|P4|Participant Flow|Phase I, Dose 3|"Group 4=IV over 30mins, 30mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
509640|NCT00321698|P3|Participant Flow|Phase I, Dose 2|"Group 3=IV over 30mins, 20mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
509641|NCT00321698|P2|Participant Flow|Phase I, Dose 1|"Group 2=IV over 30mins, 10mg/m2 weekly x 5 weeks starting on day one of radiation;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)~Chemotherapy (Groups 2-4): Docetaxel IV over 30mins weekly x 5 weeks starting on day one of radiation. The maximum planned dose of 30 mg/m2 was reached without Dose-Limiting Toxicities."
509642|NCT00321698|P1|Participant Flow|Phase I, Radiation Only|"Group 1=radiation only;~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509643|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
509644|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
509645|NCT00321698|O2|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509646|NCT00321698|O1|Outcome|Phase I Dose 1-4|"Group 1=radiation only; Group 2=Docetaxel IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=Docetaxel IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509647|NCT00321698|O1|Outcome|All Research Participants|"This Outcome Measure was assessed in aggregate, combining participants from both phases of the study, as per the planned protocol.~Phase I: Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Phase II: Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation.~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)."
509648|NCT00321698|O1|Outcome|Phase II MTD Dose|"Phase II with no phase I dose-limiting toxicities=Docetaxel IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509649|NCT00321698|O1|Outcome|Phase I Dose 1-4|"4 groups of men in phase I study.~Group 1=radiation only; Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation; Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation; Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation."
509650|NCT00321698|E5|Reported Event|Phase II, MTD Dose|"Drug: docetaxel~Phase II with no phase I dose-limiting toxicities=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509651|NCT00321698|E4|Reported Event|Phase I, Dose 3|"Drug: docetaxel~4 groups of men in phase I study.~Group 4=IV over 30mins, 30mg/m2; weekly x 5 weeks starting on day one of radiation~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509652|NCT00321698|E3|Reported Event|Phase I, Dose 2|"Drug: docetaxel~4 groups of men in phase I study.~Group 3=IV over 30mins, 20mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509653|NCT00321698|E2|Reported Event|Phase I, Dose 1|"Drug: docetaxel~4 groups of men in phase I study.~Group 2=IV over 30mins, 10mg/m2; weekly x 5 weeks starting on day one of radiation;~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509654|NCT00321698|E1|Reported Event|Phase I, Radiation Only|"Drug: N/A~4 groups of men in phase I study.~Group 1=radiation only~Radiation: radiation therapy~All men receive same radiation treatment protocol. External Beam, 45 Gy (1.8 Gy fractions), 5 per week (daily) x 5 weeks (25 fractions)"
509655|NCT00321685|B1|Baseline|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509656|NCT00321685|P1|Participant Flow|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab.~radiation therapy: Patients undergo 3-dimensional conformal radiation therapy once daily 5 days"
509657|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509658|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509659|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509660|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509679|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
509661|NCT00321685|O1|Outcome|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-12 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509662|NCT00321685|E1|Reported Event|Arm I|"Preoperative radiation therapy: Patients undergo radiotherapy once daily 5 days a week.~Preoperative chemotherapy: Patients receive oral capecitabine twice daily 5 days a week for 5.5 weeks. Patients also receive oxaliplatin IV over 2 hours on days 1, 8, 15, 22, and 29 and bevacizumab IV over 30-90 minutes on days 1, 15, and 29 during radiotherapy.~Surgery: Approximately 6-8 weeks after completion of chemoradiotherapy, patients undergo surgical resection.~Postoperative chemotherapy: Approximately 4-8 weeks after surgery, patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and bevacizumab IV over 30-90 minutes on day 1. Patients also receive fluorouracil (5-FU) IV continuously over 46 hours beginning on day 1. Treatment repeats every 2 weeks for 9 courses. Patients then receive up to 3 additional courses of leucovorin calcium, 5-FU, and bevacizumab."
509663|NCT00321672|B5|Baseline|Total|Total of all reporting groups
509664|NCT00321672|B4|Baseline|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509665|NCT00321672|B3|Baseline|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509666|NCT00321672|B2|Baseline|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509667|NCT00321672|B1|Baseline|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509668|NCT00321672|P4|Participant Flow|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509669|NCT00321672|P3|Participant Flow|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509670|NCT00321672|P2|Participant Flow|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509671|NCT00321672|P1|Participant Flow|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509672|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509673|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
509674|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509675|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509676|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509677|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509678|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509680|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509681|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509682|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509683|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509684|NCT00321672|O6|Outcome|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509685|NCT00321672|O5|Outcome|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
509686|NCT00321672|O4|Outcome|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509687|NCT00321672|O3|Outcome|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509688|NCT00321672|O2|Outcome|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509689|NCT00321672|O1|Outcome|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509690|NCT00321672|E6|Reported Event|Control, Total|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 or 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509691|NCT00321672|E5|Reported Event|NGX-4010 Total|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 or 60 minutes.
509692|NCT00321672|E4|Reported Event|Control Group , 30 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 30 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509693|NCT00321672|E3|Reported Event|NGX-4010, 30 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 30 minutes.
509694|NCT00321672|E2|Reported Event|Control Group, 60 Minutes|Treatment consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive a Control patch (low concentration capsaicin, 3.2 mcg/cm^2) for 60 minutes. The low dose of 3.2 mcg/cm^2 (0.04% w/w) used as the Control in this study was selected because it was expected to cause perceptible local sensation, thereby preserving the blind.
509695|NCT00321672|E1|Reported Event|NGX-4010, 60 Minutes|Treatment with capsaicin patches consisted of a one time application administered at any time of the day on Study Day 0. Subjects were randomized to receive NGX 4010 (high concentration capsaicin, 640 mcg/cm^2) for 60 minutes.
509696|NCT00323739|B1|Baseline|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
509697|NCT00323739|P1|Participant Flow|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
509698|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
509781|NCT00323609|P1|Participant Flow|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
516753|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
509699|NCT00323739|O1|Outcome|Bevacizumab and Everolimus|Patients received 10mg/kg of bevacizumab by IV infusion on day 1 and day 15 of each 28-day treatment cycle. Patients took 1 10mg tablet of everolimus every day for 28 days. Treatment continued until evidence of their disease worsening was found or until the side effects of treatment became intolerable to the patient. The treating physician could also stop treatment if the patient's safety was felt to be at risk.
509700|NCT00323739|E1|Reported Event|Bevacizumab + Everolimus|
509701|NCT00323635|B3|Baseline|Total|Total of all reporting groups
509702|NCT00323635|B2|Baseline|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509703|NCT00323635|B1|Baseline|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509704|NCT00323635|P2|Participant Flow|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509705|NCT00323635|P1|Participant Flow|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509706|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509707|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509708|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509709|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509710|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509711|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509712|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509713|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509714|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509715|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509716|NCT00323635|O2|Outcome|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509717|NCT00323635|O1|Outcome|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509718|NCT00323635|E2|Reported Event|Placebo|A capsule of identical to tolterodine in taste, smell and appearance that contains no tolterodine
509719|NCT00323635|E1|Reported Event|Tolterodine|Tolterodine 4 mg q.d. X 8 weeks
509720|NCT00323622|B9|Baseline|Total|Total of all reporting groups
509721|NCT00323622|B8|Baseline|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509722|NCT00323622|B7|Baseline|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509723|NCT00323622|B6|Baseline|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509724|NCT00323622|B5|Baseline|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509725|NCT00323622|B4|Baseline|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509726|NCT00323622|B3|Baseline|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509727|NCT00323622|B2|Baseline|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509778|NCT00323609|P4|Participant Flow|Vertebroplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
509782|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509728|NCT00323622|B1|Baseline|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509729|NCT00323622|P8|Participant Flow|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study
509730|NCT00323622|P7|Participant Flow|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509731|NCT00323622|P6|Participant Flow|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509732|NCT00323622|P5|Participant Flow|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509733|NCT00323622|P4|Participant Flow|Cohort 2-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509734|NCT00323622|P3|Participant Flow|Cohort 2-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509735|NCT00323622|P2|Participant Flow|Cohort 1-RTS,S/AS02A≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509736|NCT00323622|P1|Participant Flow|Cohort 1-RTS,S/AS02A<24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection
509737|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509738|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509739|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509779|NCT00323609|P3|Participant Flow|Kyphoplasty Not Treated Patients|Patients who met the enrollment criteria at screening and were randomized to treatment group had terminated prior to surgery or those who no longer met the inclusion criteria prior to surgery.
509841|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509740|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509741|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509742|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509743|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509744|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509745|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509746|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509747|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509748|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509749|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509750|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509761|NCT00323622|O6|Outcome|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509751|NCT00323622|O4|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509752|NCT00323622|O3|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509753|NCT00323622|O2|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509754|NCT00323622|O1|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509755|NCT00323622|O4|Outcome|Cohort 2-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-Engerix-B ≥24M and Cohort 2-Prevnar-Hiberix <24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509756|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. This group is part of the Cohort 2 of the study, which was followed for analysis of malaria disease, and pools subjects from the Cohort 2-RTS,S/AS02A <24M and Cohort 2-RTS,S/AS02A ≥24M groups. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509757|NCT00323622|O2|Outcome|Cohort 1-Engerix-B/Prevnar-Hiberix Group|Subjects, male and female, aged 12 up to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects, male and female, aged between 24 and 48 months first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-Engerix-B ≥24M and Cohort 1-Prevnar-Hiberix <24M groups.
509758|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A Group|Subjects, male and female, aged between 12 and 48 months at the time of the first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. This group is part of the Cohort 1 of the study, which was followed for analysis of malaria infection, and pools subjects from the Cohort 1-RTS,S/AS02A Cohort 1-RTS,S/AS02A <24M and Cohort 1-RTS,S/AS02A ≥24M groups.
509759|NCT00323622|O8|Outcome|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509760|NCT00323622|O7|Outcome|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509776|NCT00323609|B2|Baseline|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509777|NCT00323609|B1|Baseline|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509762|NCT00323622|O5|Outcome|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509763|NCT00323622|O4|Outcome|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509764|NCT00323622|O3|Outcome|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509765|NCT00323622|O2|Outcome|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509766|NCT00323622|O1|Outcome|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509767|NCT00323622|E8|Reported Event|Cohort 2-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509768|NCT00323622|E7|Reported Event|Cohort 2-Prevnar- Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509769|NCT00323622|E6|Reported Event|Cohort 1-Engerix-B ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of Engerix®-B vaccine at Months 0, 1 and 2 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509770|NCT00323622|E5|Reported Event|Cohort 1-Prevnar-Hiberix <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 2 doses of Prevnar™ vaccine at Months 0 and 2 and 1 dose of Hiberix® vaccine at Month 1 in the Primary NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509771|NCT00323622|E4|Reported Event|Cohort 2-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 of the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509772|NCT00323622|E3|Reported Event|Cohort 2-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. Subjects in this group are part of the Cohort 2 of the study, which was followed for analysis of malaria disease. As Cohort 2 subjects, subjects in this group also received as part of the Primary NCT00197041 Study one dose of sulfadoxine-pyrimethamine and amodiaquine per day for 3 days 4 weeks prior to onset of surveillance, so as to clear any parasitemia. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study.
509773|NCT00323622|E2|Reported Event|Cohort 1-RTS,S/AS02A ≥24M Group|Subjects, male and female, aged between 24 and 48 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509774|NCT00323622|E1|Reported Event|Cohort 1-RTS,S/AS02A <24M Group|Subjects, male and female, aged 12 to 24 months at first vaccination, were administered 3 doses of RTS,S/AS02A (GSK 257049) vaccine at Months 0, 1 and 2 in the NCT00197041 Study. No additional dose of vaccine or drug was administered during this open follow-up NCT00323622 study. Subjects in this group are part of the Cohort 1 of the study, which was followed for analysis of malaria infection.
509775|NCT00323609|B3|Baseline|Total|Total of all reporting groups
509783|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509784|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509785|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509786|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509787|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509788|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509789|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509790|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509791|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509792|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509793|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509794|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509795|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509796|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509797|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509798|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509799|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509800|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509801|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509802|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509803|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509804|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509805|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509806|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509807|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509808|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509809|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509810|NCT00323609|O2|Outcome|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509811|NCT00323609|O1|Outcome|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509812|NCT00323609|E2|Reported Event|Vertebroplasty|This group of patients has received vertebroplasty procedure.
509813|NCT00323609|E1|Reported Event|Kyphoplasty|This group of patients has received balloon kyphoplasty procedure.
509814|NCT00323557|B3|Baseline|Total|Total of all reporting groups
509815|NCT00323557|B2|Baseline|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
509816|NCT00323557|B1|Baseline|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
509817|NCT00323557|P2|Participant Flow|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
509818|NCT00323557|P1|Participant Flow|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
509819|NCT00323557|O3|Outcome|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0. No CM-CSF.
509820|NCT00323557|O2|Outcome|Pneumococcal Vaccine + Post Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given Day 0 (day of pneumococcal vaccine), and post vaccination at Day +3 and Day +7.
509821|NCT00323557|O1|Outcome|Pneumococcal Vaccine + Pre Vaccine GM-CSF|Vaccine subcutaneously + GM-CSF 3 Doses of 250 mg subcutaneously given pre vaccination Day -7, Day -1 and Day 0 (day of pneumococcal vaccine).
509822|NCT00323557|E2|Reported Event|Pneumococcal Vaccine Alone|First vaccine dose subcutaneously, Day 0.
509823|NCT00323557|E1|Reported Event|Pneumococcal Vaccine + GM-CSF|Vaccine subcutaneously + GM-CSF (3 Doses of 250 mg subcutaneously) given either Pre Vaccine at Day -7, Day -1 and Day 0 (day of pneumococcal vaccine) or Post Vaccine given at Day 0, Day +3 and Day +7.
509824|NCT00323492|B3|Baseline|Total|Total of all reporting groups
509825|NCT00323492|B2|Baseline|Maintain Baseline Regimen|Maintain baseline regimen.
509826|NCT00323492|B1|Baseline|Truvada|Truvada + NNRTI or PI.
509827|NCT00323492|P3|Participant Flow|Delayed Truvada|Truvada + NNRTI or PI (participants from the control group who switched NRTIs to Truvada during Study Phase 2).
509828|NCT00323492|P2|Participant Flow|Maintain Baseline Regimen|Maintain baseline regimen.
509829|NCT00323492|P1|Participant Flow|Truvada|Truvada + nonnucleoside reverse transcriptase inhibitor (NNRTI) or protease inhibitor (PI).
509830|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509831|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509832|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509833|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509834|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509835|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509836|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509837|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509838|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509839|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509840|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509842|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509843|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509844|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509845|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509846|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509847|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509848|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509849|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509850|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509851|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509852|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509853|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509854|NCT00323492|O2|Outcome|Maintain Baseline Regimen|Maintain baseline regimen.
509855|NCT00323492|O1|Outcome|Truvada|Truvada + NNRTI or PI.
509856|NCT00323492|E3|Reported Event|All Truvada|"Truvada + NNRTI or PI (all participants who received Truvada during the study, i.e., participants in the Truvada and Delayed Truvada groups). The number of participants at risk is the number who started the study by switching to Truvada (Truvada group), plus those who started the study by maintaining their baseline regimen but who switched to Truvada during the study (Delayed Truvada group). The number of participants at risk increases over time (from 47 at baseline to 72 when the last switch to Truvada took place; 25 participants switched to Truvada from the maintain baseline regimen group in Study Phase 2)."
509857|NCT00323492|E2|Reported Event|Maintain Baseline Regimen|Maintain baseline regimen. The number of participants at risk is the number who started the study by maintaining their baseline regimen. Per protocol, participants in this group were allowed to switch to Truvada after Week 12 (Delayed TVD group), therefore the number of participants at risk declines over time (from 45 at baseline to 17 who completed Study Phase 2; with most participants switching to Truvada at Week 12).
509858|NCT00323492|E1|Reported Event|Truvada|Truvada + NNRTI or PI. The number of participants at risk is the number who started the study by switching to Truvada. Participants in this group were to remain on Truvada for 48 weeks (duration of the study). The number at risk was reduced only by study discontinuation (from 47 at baseline to 40 who completed Study Phase 2).
509859|NCT00323479|B1|Baseline|Anastrozole 1 mg|Anastrozole 1 mg once daily
509860|NCT00323479|P1|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg once daily
509861|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509862|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509863|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509864|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509865|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509866|NCT00323479|O1|Outcome|Anastrozole 1 mg|Anastrozole 1 mg once daily
509867|NCT00323479|E1|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg once daily
509868|NCT00323427|B3|Baseline|Total|Total of all reporting groups
509869|NCT00323427|B2|Baseline|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509870|NCT00323427|B1|Baseline|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509871|NCT00323427|P2|Participant Flow|Hearing Aids|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509872|NCT00323427|P1|Participant Flow|Group Aural Rehabilitation|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509873|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509874|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509875|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509876|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509877|NCT00323427|O2|Outcome|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509878|NCT00323427|O1|Outcome|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509879|NCT00323427|E2|Reported Event|Arm 2|Veterans receive new VA issued digital hearing aids per Standard VA Audiology Hearing Aid services
509880|NCT00323427|E1|Reported Event|Arm 1|Group Aural Rehabilitation session, two hours in length, approximately 6 participants plus Group Facilitator
509881|NCT00321646|B1|Baseline|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
509882|NCT00321646|P1|Participant Flow|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
509917|NCT00323362|E1|Reported Event|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509918|NCT00323310|B1|Baseline|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509883|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
509884|NCT00321646|O1|Outcome|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
509885|NCT00321646|E1|Reported Event|Chemotherapy|"docetaxel and bevacizumab prior to prostatectomy~Docetaxel : Docetaxel will be given intravenously once every 21 days in the infusion center. The starting dose is 70mg/square meter.~Bevacizumab : Bevacizumab (marketed as Avastin, Genentech) is an antibody to all isoforms of vascular endothelial growth factor and is the first putative anti-angiogenic agent approved by the Food and Drug Administration (FDA) for the treatment of cancer.All subjects will be treated with intravenous docetaxel and bevacizumab for 5 cycles, followed by docetaxel alone for Cycle 6. Bevacizumab will be given first, at a starting dose of 15 mg/kg. Bevacizumab will be given once every 21 days in the infusion center."
509886|NCT00321620|B3|Baseline|Total|Total of all reporting groups
509887|NCT00321620|B2|Baseline|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
509888|NCT00321620|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
509889|NCT00321620|P2|Participant Flow|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
509890|NCT00321620|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
509891|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
509892|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
509893|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
509894|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
509895|NCT00321620|O2|Outcome|Denosumab|Denosumab 120 mg subcutaneously with an intravenous zoledronic acid placebo once every 4 weeks
509896|NCT00321620|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with a subcutaneous denosumab placebo once every 4 weeks
509897|NCT00321620|E2|Reported Event|Denosumab 120 mg Q4W|
509898|NCT00321620|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
509899|NCT00321464|B3|Baseline|Total|Total of all reporting groups
509900|NCT00321464|B2|Baseline|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
509901|NCT00321464|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
509902|NCT00321464|P2|Participant Flow|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
509903|NCT00321464|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
509904|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
509905|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
509906|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
509907|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
509908|NCT00321464|O2|Outcome|Denosumab|Denomsumab 120 mg subcutaneously with intravenous zoledronic acid placebo once every 4 weeks
509909|NCT00321464|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg by intravenous injection with subcutaneous denosumab placebo once every 4 weeks
509910|NCT00321464|E2|Reported Event|Denosumab 120 mg Q4W|
509911|NCT00321464|E1|Reported Event|Zoledronic Acid 4 mg Q4W|
509912|NCT00323362|B1|Baseline|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509913|NCT00323362|P1|Participant Flow|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509914|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509915|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509916|NCT00323362|O1|Outcome|Gemcitabine Hydrochloride and Imatinib Mesylate|"gemcitabine hydrochloride : 1000 mg/m2 given intravenously at a FDR of 10 mg/m2/min on Days 3 and 10, every 21 days.~imatinib mesylate : 400 mg/day orally, given Days 1-5 and 8-12 every 21 days"
509919|NCT00323310|P1|Participant Flow|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509920|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509921|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509922|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509923|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509924|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509925|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509926|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509927|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509928|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509929|NCT00323310|O1|Outcome|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509930|NCT00323310|E1|Reported Event|Gadobenate Dimeglumine|Contrast Agent, 0.10 mmol/kg injection
509931|NCT00323297|B3|Baseline|Total|Total of all reporting groups
509932|NCT00323297|B2|Baseline|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509933|NCT00323297|B1|Baseline|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509934|NCT00323297|P2|Participant Flow|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509935|NCT00323297|P1|Participant Flow|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509936|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509937|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509938|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509939|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509940|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509941|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509942|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509943|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509944|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509945|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509946|NCT00323297|O2|Outcome|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509947|NCT00323297|O1|Outcome|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months"
509972|NCT00323258|B3|Baseline|Total|Total of all reporting groups
509948|NCT00323297|E2|Reported Event|Sildenafil|"In Part A of the study: the participants received sildenafil 20 mg TID, in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509949|NCT00323297|E1|Reported Event|Placebo|"In Part A of the study: the participants received placebo three times a day (TID), in addition to their existing stable bosentan treatment (62.5 mg BID or 125 mg BID for minimum 3 months prior to randomization), for 12-Week Double-Blind Phase of the study.~In Part B of the study: All the participants received sildenafil 20 mg TID for 12 months."
509950|NCT00323284|B3|Baseline|Total|Total of all reporting groups
509951|NCT00323284|B2|Baseline|B--Cataract Surgery Only|Cataract Surgery only
509952|NCT00323284|B1|Baseline|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
509953|NCT00323284|P2|Participant Flow|B--Cataract Surgery Only|Cataract Surgery only
509954|NCT00323284|P1|Participant Flow|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
509955|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
509956|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
509957|NCT00323284|O2|Outcome|B--Cataract Surgery Only|Cataract Surgery only
509958|NCT00323284|O1|Outcome|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
509959|NCT00323284|E2|Reported Event|B--Cataract Surgery Only|Cataract Surgery only
509960|NCT00323284|E1|Reported Event|A--iStent Plus Cataract Surgery|iStent plus Cataract Surgery
509961|NCT00323271|B3|Baseline|Total|Total of all reporting groups
509962|NCT00323271|B2|Baseline|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
509963|NCT00323271|B1|Baseline|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
509964|NCT00323271|P2|Participant Flow|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
509965|NCT00323271|P1|Participant Flow|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
509966|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
509967|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
509968|NCT00323271|O2|Outcome|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
509969|NCT00323271|O1|Outcome|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
509970|NCT00323271|E2|Reported Event|Educational Intervention|"Interventional: Educational intervention~Interventional: Educational intervention: Session topics will include information on the etiology of MS, MS subtypes and disease progression, common symptoms of MS, medical management of MS, rehabilitation approaches to management of MS-related symptoms, exercise, sick day management, stress management, psychosocial adjustment, family involvement, and appropriate use of the health care system."
509971|NCT00323271|E1|Reported Event|Cognitive-behavior Therapy|"Behavioral: Cognitive-behavior therapy~Cognitive-behavior therapy: CBT: The components of CBT include (1) identification of idiosyncratic beliefs about pain and pain treatment, as well as reconceptualization of the pain experience as subject to personal control (sessions 1-2), (2) instruction in specific cognitive (e.g., distraction) and behavioral (e.g., change in activity patterns such as alternating activity with periods of rest) skills (sessions 3-8), and (3) consolidation of cognitive/behavioral skills through activities such as role playing (sessions 9-11)."
509973|NCT00323258|B2|Baseline|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
509974|NCT00323258|B1|Baseline|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
509975|NCT00323258|P2|Participant Flow|Usual Care|"The usual care group received routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.~The control arm originally contained 72 subjects, 53 completed the 6 month follow-up phone call and 58 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
509976|NCT00323258|P1|Participant Flow|Intervention Arm|"Patients enrolled in the intervention arm received inpatient education on the importance of medication and assessment of barriers to adherence. A pill box, pocket medication card, and tips for remembering to take medications were provided. The community pharmacist was notified of the subject's enrollment. The community pharmacist was asked to reinforce importance of evidence-based medications and assess the subject's medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.~The intervention arm originally contained 71 subjects, 55 completed the 6 month follow-up phone call and 57 had refill records available at 6 months post-discharge. The periods listed here represent the same 6 month period with different numbers of particpants having the phone call or refill records available."
509977|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509978|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
509979|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509980|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
509981|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509982|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
509983|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509984|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
509985|NCT00323258|O2|Outcome|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509986|NCT00323258|O1|Outcome|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
510293|NCT00322452|E2|Reported Event|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
509987|NCT00323258|E2|Reported Event|Usual Care|Routine discharge counseling performed by the patient-care nurse and a letter/discharge summary from the hospital physician to the community physician listing the discharge medications, procedures, and recommendations. Enrolled patients in the usual care arm were not disclosed to the community pharmacy until the end of the study period when refill records were requested.
509988|NCT00323258|E1|Reported Event|Intervention|Inpatient education on the importance of medication and assessment of barriers to adherence, pill box, pocket medication card, and tips for remembering to take medications. Community pharmacist reinforced importance of medications and assessed medication adherence every 6 weeks for 6 months. If a problem was noted, the subject's health care team will be notified.
509989|NCT00323193|B3|Baseline|Total|Total of all reporting groups
509990|NCT00323193|B2|Baseline|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
509991|NCT00323193|B1|Baseline|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
509992|NCT00323193|P2|Participant Flow|Control Group|The control group offers basic information about diet and exercise every month for six months.
509993|NCT00323193|P1|Participant Flow|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
509994|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
509995|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
509996|NCT00323193|O2|Outcome|Control Group|The control group offers basic information about diet and exercise every month for six months.
509997|NCT00323193|O1|Outcome|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
509998|NCT00323193|E2|Reported Event|Control Group|The control condition offers basic information about diet and exercise on a monthly basis.
509999|NCT00323193|E1|Reported Event|MOVE Group|"The intervention group completes approximately 8 individual level sessions with a MOVE specialist as well as approximately 8 group level intervention sessions.~MOVE!: group based psychoeducation, motivation and support"
510000|NCT00323115|B1|Baseline|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
510001|NCT00323115|P1|Participant Flow|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
510002|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
510003|NCT00323115|O1|Outcome|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
510004|NCT00323115|E1|Reported Event|Vaccine|Adult patients who have surgical resection of newly diagnosed glioblastoma multiforme (GBM) will be treated with radiotherapy and concurrent chemotherapy followed by intranodal vaccine with autologous dendritic cells (DCs) primed with tumor lysate. Adjuvant chemotherapy will be administered after vaccination for 1 year or until tumor progression
510005|NCT00323037|B3|Baseline|Total|Total of all reporting groups
510006|NCT00323037|B2|Baseline|Coreg Controlled Release|
510007|NCT00323037|B1|Baseline|Coreg Immediate Release|
510008|NCT00323037|P2|Participant Flow|Coreg Controlled Release|
510009|NCT00323037|P1|Participant Flow|Coreg Immediate Release|
510010|NCT00323037|O2|Outcome|Coreg Controlled Release|
510011|NCT00323037|O1|Outcome|Coreg Immediate Release|
510012|NCT00322881|B1|Baseline|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
510013|NCT00322881|P1|Participant Flow|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
510014|NCT00322881|O1|Outcome|Carboplatin/Paclitaxel|Patients received chemotherapy on day 1 of a 21 day cycle for 6 cycles. Paclitaxel was given via peripheral or central IV catheter at the dose of 175 mg/m2 over 3 hours. IV carboplatin followed using a dose of Area Under the Curve (AUC) equal to 5 with creatinine clearance based on Jelliffe formula.
510015|NCT00322881|E1|Reported Event|Carboplatin/Paclitaxel|"Paclitaxel: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)~Carboplatin: Chemotherapy will be given per standard treatment practices for 6 cycles (18 weeks)"
510016|NCT00322855|B1|Baseline|Chart Review|patients diagnosed with soft tissue sarcoma
510017|NCT00322855|P1|Participant Flow|Chart Review|patients diagnosed with soft tissue sarcoma
510018|NCT00322855|O1|Outcome|Chart Review|patients diagnosed with soft tissue sarcoma
510019|NCT00322855|E1|Reported Event|Chart Review|patients diagnosed with soft tissue sarcoma
510020|NCT00322842|B3|Baseline|Total|Total of all reporting groups
510021|NCT00322842|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510022|NCT00322842|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510023|NCT00322842|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510024|NCT00322842|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510025|NCT00322842|O3|Outcome|All Participants|
510026|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510027|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510028|NCT00322842|O3|Outcome|All Participants|
510029|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510030|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510031|NCT00322842|O3|Outcome|All Participants|
510032|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510033|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510034|NCT00322842|O3|Outcome|All Participants|
510035|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510036|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510037|NCT00322842|O3|Outcome|All Participants|
510038|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510039|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510040|NCT00322842|O3|Outcome|All Participants|
510041|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510067|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510294|NCT00322452|E1|Reported Event|Gefitinib|Gefitinib 250mg daily
510042|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510043|NCT00322842|O3|Outcome|All Participants|
510044|NCT00322842|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510045|NCT00322842|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510046|NCT00322842|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510047|NCT00322842|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510048|NCT00321373|B4|Baseline|Total|Total of all reporting groups
510049|NCT00321373|B3|Baseline|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510050|NCT00321373|B2|Baseline|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510051|NCT00321373|B1|Baseline|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510052|NCT00321373|P3|Participant Flow|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510053|NCT00321373|P2|Participant Flow|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510054|NCT00321373|P1|Participant Flow|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510055|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510056|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510057|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510058|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510059|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510060|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510061|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510062|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510063|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510064|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510065|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510066|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510179|NCT00322491|O3|Outcome|All Participants|
510401|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510068|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510069|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510070|NCT00321373|O3|Outcome|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510071|NCT00321373|O2|Outcome|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510072|NCT00321373|O1|Outcome|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510073|NCT00321373|E3|Reported Event|Fluarix Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of Fluarix vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510074|NCT00321373|E2|Reported Event|GSK1247446A Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of non-adjuvanted GSK1247446A vaccine. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510075|NCT00321373|E1|Reported Event|GSK1247446A-AS03 Group|Subjects aged 60 years or older at the time of the vaccination who received 1 dose of GSK1247446A vaccine adjuvanted with AS03. The vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
510076|NCT00321321|B1|Baseline|Sulfonylurea|
510077|NCT00321321|P1|Participant Flow|Sulfonylurea|
510078|NCT00321321|O1|Outcome|Sulfonylurea|
510079|NCT00321321|E1|Reported Event|Sulfonylurea|Sulfonylurea-treated patients
510080|NCT00322777|B3|Baseline|Total|Total of all reporting groups
510081|NCT00322777|B2|Baseline|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510082|NCT00322777|B1|Baseline|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510083|NCT00322777|P2|Participant Flow|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510084|NCT00322777|P1|Participant Flow|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510085|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510086|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510087|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510088|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510089|NCT00322777|O2|Outcome|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510090|NCT00322777|O1|Outcome|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510091|NCT00322777|E2|Reported Event|Waitlist Control Group|Arm where participants began the intervention (the Spirituality Teaching Program) after an 8 week wait period. Therefore, the program was initiated at week 8 of the trial. Between week 1 and week 8, participants were instructed to carry out their day to day activities as before.
510092|NCT00322777|E1|Reported Event|Spirituality Group|Arm where participants began the intervention (the Spirituality Teaching Program) upon recruitment for an 8 week period. Therefore, the program was initiated at week 1 of the trial.
510093|NCT00322712|B1|Baseline|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
510094|NCT00322712|P1|Participant Flow|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
510095|NCT00322712|O1|Outcome|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
510096|NCT00322712|E1|Reported Event|Treatment Arm|Retrospective chart review for the period from 10/2005-8/2006 done on all patients with metastatic pancreatic cancer treated at the UNM Cancer Center with OIC (Oxaliplatin 60mg/m2, Irinotecan 90mg/m2, and Cetuximab 250 mg/m2 delivered every other week).
510290|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510097|NCT00322621|B1|Baseline|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
510098|NCT00322621|P3|Participant Flow|Rescue Arm|Duloxetine: 120 milligrams once daily.
510099|NCT00322621|P2|Participant Flow|Maintenance Arm|Duloxetine: 60 milligrams once daily.
510100|NCT00322621|P1|Participant Flow|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months.
510101|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
510102|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
510103|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
510104|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
510105|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
510106|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
510107|NCT00322621|O2|Outcome|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
510108|NCT00322621|O1|Outcome|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
510109|NCT00322621|O4|Outcome|Rescue Arm|duloxetine 120 mg once daily
510110|NCT00322621|O3|Outcome|Maintenance Arm (Later Dose Increase)|duloxetine 60 mg once daily and then increasing to 120 mg once daily
510111|NCT00322621|O2|Outcome|Maintenance Arm (No Dose Increase)|duloxetine 60 mg once daily
510112|NCT00322621|O1|Outcome|All Maintenance / Rescue Participants|Total of the Maintenance (No Dose Increase), Maintenance (Later Dose Increase) and Rescue arms. Depending on the group the patient was in, they either received duloxetine 60 mg once daily; 60 mg once daily and then increased to 120 mg once daily; or 120 mg once daily.
510113|NCT00322621|O1|Outcome|Acute Phase|All subjects receive 30 milligrams (mg) duloxetine once daily (QD), by mouth (PO) for 1 week followed by duloxetine 60 mg QD, PO for 7 weeks, then maintenance at 60 mg QD, PO for responders to 6 months and rescue at 120 mg QD, PO for non-responders to 6 months
510114|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510115|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510116|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510117|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510118|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510119|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510120|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510121|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510122|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510123|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510124|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510125|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510126|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510127|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510128|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510129|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510130|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510131|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510132|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510133|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510134|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510135|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510136|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510137|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510138|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510139|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510140|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510141|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510142|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510143|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510144|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510145|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510146|NCT00322621|O1|Outcome|Rescue Arm|Duloxetine: 120 milligrams once daily
510147|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510148|NCT00322621|O1|Outcome|Maintenance Arm|Duloxetine: 60 milligrams once daily
510149|NCT00322621|E2|Reported Event|Duloxetine 120 mg|Duloxetine: 120 milligrams once daily
510150|NCT00322621|E1|Reported Event|Duloxetine 60 mg|Duloxetine: 60 milligrams once daily
510151|NCT00322556|B1|Baseline|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510152|NCT00322556|P1|Participant Flow|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510153|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510154|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
516754|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
510155|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510156|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510157|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510158|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510159|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510160|NCT00322556|O3|Outcome|IgPro10 (> 8 to ≤ 12 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the high maximum infusion rate (> 8 and ≤ 12 mg/kg/min) for old subjects.
510161|NCT00322556|O2|Outcome|IgPro10 (≤ 8 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the low maximum infusion rate (≤ 8 mg/kg/min) for old subjects.
510162|NCT00322556|O1|Outcome|IgPro10 (≤ 4 mg/kg/Min)|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study, at the maximum infusion rate (≤ 4 mg/kg/min) for new subjects.
510163|NCT00322556|O1|Outcome|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510164|NCT00322556|E1|Reported Event|IgPro10|A 10% liquid formulation of human immunoglobulin G (stabilized with 250 millimole per liter of L-proline) administered as an intravenous infusion, every 3 or 4 weeks for the duration of the study.
510165|NCT00322491|B3|Baseline|Total|Total of all reporting groups
510166|NCT00322491|B2|Baseline|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510167|NCT00322491|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510168|NCT00322491|P2|Participant Flow|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510169|NCT00322491|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510170|NCT00322491|O3|Outcome|All Participants|
510171|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510172|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510173|NCT00322491|O3|Outcome|All Participants|
510174|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510175|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510176|NCT00322491|O3|Outcome|All Participants|
510177|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510178|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510180|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510181|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510182|NCT00322491|O3|Outcome|All Participants|
510183|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510184|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510185|NCT00322491|O3|Outcome|All Participants|
510186|NCT00322491|O2|Outcome|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510187|NCT00322491|O1|Outcome|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510188|NCT00322491|E2|Reported Event|Multiple Myeloma (MM)|Participants with MM were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510189|NCT00322491|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL)|Participants with NHL were mobilized with granulocyte colony-stimulating factor (G-CSF) 10 µg/kg/day for 4 days. Plerixafor 240 µg/kg was given the evening of day 4 and G-CSF given the next morning followed by apheresis. Evening doses of plerixafor and morning doses of G-CSF followed by apheresis continued for up to a maximum of 5 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
510190|NCT00322465|B5|Baseline|Total|Total of all reporting groups
510191|NCT00322465|B4|Baseline|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510192|NCT00322465|B3|Baseline|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510193|NCT00322465|B2|Baseline|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510194|NCT00322465|B1|Baseline|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510195|NCT00322465|P4|Participant Flow|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510196|NCT00322465|P3|Participant Flow|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510197|NCT00322465|P2|Participant Flow|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510198|NCT00322465|P1|Participant Flow|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510199|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510200|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510201|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510202|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510203|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510204|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510205|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510206|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510402|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510207|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510208|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510209|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510210|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510211|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510212|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510213|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510214|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510215|NCT00322465|O1|Outcome|All Participants Analyzed|
510216|NCT00322465|O1|Outcome|All Participants Analyzed|
510217|NCT00322465|O1|Outcome|All Participants Analyzed|
510218|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510219|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510220|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510221|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510222|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510223|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510224|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510225|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510226|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510227|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510228|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510229|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510230|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510231|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510232|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510233|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510234|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510235|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510236|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510237|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510238|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510239|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510240|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510241|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510291|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510292|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510242|NCT00322465|O2|Outcome|Azithromycin + (Azithromycin + Tinidazole)|Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole placebo single dose + (Azithromycin 1 gm PO single dose (2 tablets at 500 mg each) plus doxycycline placebo BID for 7 days plus tinidazole single dose (4 tablets at 500 mg each))
510243|NCT00322465|O1|Outcome|Doxycycline + (Doxycycline + Tinidazole)|Doxycycline 100 mg PO BID (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin PO single dose and placebo tinidazole + (Doxycycline 100 mg PO BID for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm PO single dose (4 tablets at 500 mg each)).
510244|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510245|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510246|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510247|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510248|NCT00322465|O4|Outcome|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510249|NCT00322465|O3|Outcome|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510250|NCT00322465|O2|Outcome|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510251|NCT00322465|O1|Outcome|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510252|NCT00322465|E4|Reported Event|Azithromycin + Tinidazole|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole single dose (4 tablets at 500 mg each).
510253|NCT00322465|E3|Reported Event|Azithromycin|Azithromycin 1 gm by mouth single dose (2 tablets at 500 mg each) plus doxycycline placebo twice a day for 7 days plus tinidazole placebo single dose.
510254|NCT00322465|E2|Reported Event|Doxycycline + Tinidazole|Doxycycline 100 mg by mouth twice a day for 7 days plus placebo azithromycin single dose plus tinidazole 2 gm by mouth single dose (4 tablets at 500 mg each).
510255|NCT00322465|E1|Reported Event|Doxycycline|Doxycycline 100 mg by mouth twice a day (2 pills/day = 200 mg/day) for 7 days plus placebo azithromycin by mouth single dose and placebo tinidazole.
510256|NCT00322452|B3|Baseline|Total|Total of all reporting groups
510257|NCT00322452|B2|Baseline|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510258|NCT00322452|B1|Baseline|Gefitinib|Gefitinib 250mg daily
510259|NCT00322452|P2|Participant Flow|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510260|NCT00322452|P1|Participant Flow|Gefitinib|Gefitinib 250mg daily
510261|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510262|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510263|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510264|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510265|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510266|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510267|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510268|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510269|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510270|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510271|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510272|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510273|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510274|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510275|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510276|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510277|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510278|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510279|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510280|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510281|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510282|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510283|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510284|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510285|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510286|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510287|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510288|NCT00322452|O1|Outcome|Gefitinib|Gefitinib 250mg daily
510289|NCT00322452|O2|Outcome|Carboplatin/Paclitaxel|Carboplatin AUC 5.0 or 6.0 and Paclitaxel 200 mg/m^2 doublet chemotherapy every 3 weeks
510295|NCT00322439|B1|Baseline|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510296|NCT00322439|P1|Participant Flow|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510297|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510298|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510299|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510300|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510301|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510302|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510303|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510304|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510305|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510306|NCT00322439|O1|Outcome|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510307|NCT00322439|E1|Reported Event|Etanercept|Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
510308|NCT00322387|B3|Baseline|Total|Total of all reporting groups
510309|NCT00322387|B2|Baseline|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
510310|NCT00322387|B1|Baseline|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
510311|NCT00322387|P2|Participant Flow|Multiple Myeloma (MM)|Participants with multiple myeloma were assigned to any of the 4 treatment arms.
510312|NCT00322387|P1|Participant Flow|Non-Hodgkin's Lymphoma (NHL)|Participants with non-Hodgkin's lymphoma were assigned to Plerixafor PM, Plerixafor AM, and Plerixafor After Chemo treatment arms.
510361|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510362|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510618|NCT00321893|B1|Baseline|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510313|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510314|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
510315|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510316|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510317|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510318|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510319|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510320|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510321|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
510322|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510323|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510363|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510364|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510324|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510325|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510326|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510327|NCT00322387|O8|Outcome|All Participants|
510328|NCT00322387|O7|Outcome|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510329|NCT00322387|O6|Outcome|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was administered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days.
510330|NCT00322387|O5|Outcome|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510331|NCT00322387|O4|Outcome|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510332|NCT00322387|O3|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen. This investigational cohort evaluated the effect of administering plerixafor before white blood cell recovery.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510333|NCT00322387|O2|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510334|NCT00322387|O1|Outcome|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510335|NCT00322387|E7|Reported Event|Multiple Myeloma (MM): Plerixafor After Chemo|"Participants with MM who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510365|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510366|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510336|NCT00322387|E6|Reported Event|Multiple Myeloma (MM): Low CD34+ Count/Plerixafor PM|"Participants with MM who followed the Low CD34+ Count/Plerixafor PM treatment arm regimen.~Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. If participants had a CD34+ count of >=10 cells/µL but <20 cells/µL on 2 consecutive days, plerixafor (240 µg/kg) was given in the evening. G-CSF was adminstered and apheresis performed in the morning. Plerixafor (240 µg/kg) administered in the evening followed by G-CSF and apheresis 10 to 11 hours later was repeated for up to 4 consecutive days."
510337|NCT00322387|E5|Reported Event|Multiple Myeloma (MM): Plerixafor AM|Participants with MM who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510338|NCT00322387|E4|Reported Event|Multiple Myeloma (MM): Plerixafor PM|Participants with MM who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510339|NCT00322387|E3|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor After Chemo|"Participants with NHL who followed the Plerixafor After Chemo treatment arm regimen.~Participants received mobilizing chemotherapy, followed by 5 consecutive days of G-CSF (10 µg/kg). Starting on the sixth day, participants received G-CSF (10 µg/kg) plus plerixafor (240 µg/kg) daily for up to 3 consecutive days. If CD34+ counts reached >= 20 cells/µL 6 hours after any of the 3 plerixafor doses, apheresis began. If not, G-CSF administration continued until the participant qualified for one of the other treatment arms."
510340|NCT00322387|E2|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor AM|Participants with NHL who followed the Plerixafor AM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. The morning of the second day after the first apheresis, plerixafor (240 µg/kg) was administered followed by apheresis 6 hours later. Plerixafor (240 µg/kg) was administered in the morning followed by apheresis 6 hours later for up to 4 consecutive days.
510341|NCT00322387|E1|Reported Event|Non-Hodgkin's Lymphoma (NHL): Plerixafor PM|Participants with NHL who followed the Plerixafor PM treatment arm regimen. Participants received chemotherapy and G-CSF mobilization for 7 days according to standard procedures at the study center. When participants achieved a target CD34+ count of ≥20 cells/µL, apheresis began. G-CSF was given daily in the morning on the days of apheresis. After the first apheresis, plerixafor (240 µg/kg) was administered each evening (approximately 10pm) followed by apheresis 10 to 11 hours later for up to 4 consecutive days.
510342|NCT00322374|B4|Baseline|Total|Total of all reporting groups
510343|NCT00322374|B3|Baseline|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510344|NCT00322374|B2|Baseline|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510345|NCT00322374|B1|Baseline|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510346|NCT00322374|P4|Participant Flow|All Participants|
510347|NCT00322374|P3|Participant Flow|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510348|NCT00322374|P2|Participant Flow|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510349|NCT00322374|P1|Participant Flow|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510350|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
510351|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
510352|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with a best response of either CR or PR.
510353|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants with measurable disease and with a best tumor response of either CR or PR.
510354|NCT00322374|O2|Outcome|All Response-evaluable Participants|Participants treated at the MTD with measurable disease at baseline per RECIST
510355|NCT00322374|O1|Outcome|All Participants With Measurable Disease|Participants with measurable disease at baseline per RECIST
510356|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510357|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510358|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510359|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510360|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510367|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510368|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510369|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510370|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510371|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510372|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510373|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510374|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510375|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510376|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510377|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510378|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510379|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510380|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510381|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510382|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510383|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510384|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510385|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510386|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510387|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510388|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510389|NCT00322374|O1|Outcome|All Participants With Measurable Disease and Tumor Response|All participants received Ixabepilone administered as a 3-hour IV infusion following a 3- to 5-minute IV infusion of Epirubicin every 21 days.
510390|NCT00322374|O3|Outcome|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510391|NCT00322374|O2|Outcome|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510392|NCT00322374|O1|Outcome|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510393|NCT00322374|E3|Reported Event|Ixabepilone 35 mg^m2 + Epirubicin 75 mg^m2|Participants received 35 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510394|NCT00322374|E2|Reported Event|Ixabepilone 30 mg^m2 + Epirubicin 75 mg^m2|Participants received 30 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510395|NCT00322374|E1|Reported Event|Ixabepilone 25 mg^m2 + Epirubicin 75 mg^m2|Participants received 25 mg/m^2 Ixabepilone as a 3-hour IV infusion following a 3- to 5-minute IV infusion of 75 mg/m^2 epirubicin every 21 days.
510396|NCT00322348|B3|Baseline|Total|Total of all reporting groups
510397|NCT00322348|B2|Baseline|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510398|NCT00322348|B1|Baseline|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510399|NCT00322348|P2|Participant Flow|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510400|NCT00322348|P1|Participant Flow|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510403|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510404|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510405|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510406|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510407|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510408|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510409|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510410|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510411|NCT00322348|O2|Outcome|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510412|NCT00322348|O1|Outcome|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510413|NCT00322348|E2|Reported Event|ZOLADEX 3.6 mg|ZOLADEX (goserelin acetate) 3.6 mg intramuscular depot for injection every 4 weeks
510414|NCT00322348|E1|Reported Event|ZOLADEX 10.8 mg|ZOLADEX (goserelin acetate) 10.8 mg intramuscular depot for injection every 12 weeks
510415|NCT00322335|B4|Baseline|Total|Total of all reporting groups
510416|NCT00322335|B3|Baseline|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510417|NCT00322335|B2|Baseline|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510418|NCT00322335|B1|Baseline|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510419|NCT00322335|P3|Participant Flow|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510420|NCT00322335|P2|Participant Flow|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510421|NCT00322335|P1|Participant Flow|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510422|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510423|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510424|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510507|NCT00321984|P3|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510425|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510426|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510427|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510428|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510429|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510430|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510431|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510432|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510433|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510434|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510435|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510436|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510508|NCT00321984|P2|Participant Flow|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
516755|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
510437|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510438|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510439|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510440|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510441|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510442|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510443|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510444|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510445|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510446|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510447|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510448|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510509|NCT00321984|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510619|NCT00321893|P2|Participant Flow|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510449|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510450|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510451|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510452|NCT00322335|O3|Outcome|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510453|NCT00322335|O2|Outcome|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510454|NCT00322335|O1|Outcome|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510455|NCT00322335|E3|Reported Event|Infanrix Hexa/Meningitec Group|Subjects were primed with Infanrix™ hexa co-administered intramuscularly with Meningitec™ in the right and left thigh respectively at 2, 4 and 6 months of age during the primary study (NCT00352963), followed by a booster dose of Infanrix™ hexa intramuscularly in the right thigh between 13 and 14 months of age in study (NCT00323050). No vaccines were administered during this long-term persistence phase of the study.
510456|NCT00322335|E2|Reported Event|Infanrix Hexa (or IPV/Hib)/NeisVac-C/Engerix-B/Menitorix Group|Subjects were either primed in the primary study (NCT00352963) with 3 doses of Infanrix™ hexa administered intramuscularly in the right thigh at 2, 4 and 6 months of age and 2 doses of NeisVac-C™ administered intramuscularly in the left thigh at 2 and 4 months of age or with Engerix-B at birth intramuscularly in the right thigh, Infanrix™ hexa intramusculary in the right thigh at 2 and 6 months of age and NeisVac-C™ intramuscularly in the left thigh at 2 and 4 months of age, Infanrix™ IPV/Hib was administered intramuscularly in the right thigh at 4 months of age. All subjects were boosted with Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510457|NCT00322335|E1|Reported Event|Menitorix/Pediarix Group|Subjects were primed with 3 doses of Pediarix™ co-administered intramuscularly with Menitorix™ in the right and left thigh respectively in the primary study (NCT00352963) at 2, 4 and 6 months of age. This was followed by a booster dose of Menitorix™ administered intramuscularly in the left thigh between 13 and 14 months of age in study NCT00323050. No vaccines were administered during this long-term persistence phase of the study.
510458|NCT00322231|B3|Baseline|Total|Total of all reporting groups
510459|NCT00322231|B2|Baseline|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
510460|NCT00322231|B1|Baseline|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
510461|NCT00322231|P2|Participant Flow|Placebo / ZOSTAVAX™|0.65mL of placebo injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of Zoster vaccine live injected subcutaneously at Week 4 (Period 2)
510462|NCT00322231|P1|Participant Flow|ZOSTAVAX™ / Placebo|0.65mL of Zoster vaccine live injected subcutaneously on Day 1 (Period 1) followed by 0.65mL of placebo injected subcutaneously at Week 4 (Period 2)
510463|NCT00322231|O2|Outcome|Placebo|Participants included in this analysis were those who received Placebo in Placebo /ZOSTAVAX™ group (on Day 1). Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group were excluded in order to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
510464|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group are included. In addition, 5 participants from the Placebo / ZOSTAVAX™ group were excluded in the prevaccination summaries (since their specimens were damaged or collected out of day range), and are not in the analysis.
510510|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510465|NCT00322231|O2|Outcome|Placebo|Participants who received placebo (at Day 1) in Placebo / ZOSTAVAX™ group. Participants who received ZOSTAVAX™ at (Day 1) in the ZOSTAVAX™ / Placebo group were excluded to avoid a possible carry-over effect of ZOSTAVAX™ on immunogenicity measurements.
510466|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included.
510467|NCT00322231|O2|Outcome|Placebo|Participants who received placebo in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ Group (see participant flow section) are included.
510468|NCT00322231|O1|Outcome|ZOSTAVAX™|Participants who received ZOSTAVAX™ in the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group (see participant flow section) are included
510469|NCT00322231|E2|Reported Event|Placebo|All participants that received Placebo in both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™. Five participants that received placebo were lost to follow up and not included in the analysis.
510470|NCT00322231|E1|Reported Event|ZOSTAVAX™|All participants that received ZOSTAVAX™ from both, the ZOSTAVAX™ / Placebo group and the Placebo / ZOSTAVAX™ group. Two participants that received ZOSTAVAX™ were lost to follow up and not included in the analysis.
510471|NCT00322153|B3|Baseline|Total|Total of all reporting groups
510472|NCT00322153|B2|Baseline|Memantine ER|28mg once daily oral administration for 24 weeks.
510473|NCT00322153|B1|Baseline|Placebo|Matching placebo oral administration once daily for 24 weeks.
510474|NCT00322153|P2|Participant Flow|Memantine ER|28mg once daily oral administration for 24 weeks.
510475|NCT00322153|P1|Participant Flow|Placebo|Matching placebo oral administration once daily for 24 weeks.
510476|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
510477|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
510478|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
510479|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
510480|NCT00322153|O2|Outcome|Memantine ER|28mg once daily oral administration for 24 weeks.
510481|NCT00322153|O1|Outcome|Placebo|Matching placebo oral administration once daily for 24 weeks.
510482|NCT00322153|E2|Reported Event|Memantine ER|28mg once daily oral administration for 24 weeks.
510483|NCT00322153|E1|Reported Event|Placebo|Matching placebo oral administration once daily for 24 weeks.
510484|NCT00322101|B3|Baseline|Total|Total of all reporting groups
510485|NCT00322101|B2|Baseline|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510486|NCT00322101|B1|Baseline|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510487|NCT00322101|P2|Participant Flow|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510488|NCT00322101|P1|Participant Flow|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510489|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510490|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510502|NCT00322101|E1|Reported Event|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510491|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510492|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510493|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510494|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510495|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510496|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510497|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510498|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510499|NCT00322101|O2|Outcome|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510500|NCT00322101|O1|Outcome|Arm I (Nonmyeloablative Regimen)|"CONDITIONING: Patients receive fludarabine phosphate IV on days -4 to -2 and undergo low-dose total-body irradiation on day 0.~TRANSPLANTATION: Patients undergo allogeneic peripheral blood stem cell (PBSC) infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive cyclosporine every 12 hours on days -3 to 57 with taper on days 57-177 or cyclosporine every 12 hours on days -3 to 100 with taper on days 101-177. Patients also receive oral mycophenolate mofetil every 12 hours on days 0-27 or every 8 hours on days 0-40 with taper on days 41-96."
510501|NCT00322101|E2|Reported Event|Arm II (Myeloablative Regimen)|"CONDITIONING: Patients are assigned to 1 of 2 treatment groups.~Group A: Patients receive fludarabine IV once daily and oral busulfan four times daily or busulfan IV over 3 hours on days -5 to -2.~Group B: Patients receive cyclophosphamide IV over 1-2 hours on days -3 and -2 and oral busulfan four times daily or busulfan IV over 3 hours on days -7 to -4.~TRANSPLANTATION: Patients undergo PBSC infusion on day 0.~GRAFT-VS-HOST DISEASE PROPHYLAXIS: Patients receive tacrolimus IV continuously or orally every 12 hours on days -1 to 56 and taper on days 57-200. Patients also receive methotrexate IV on days 1, 3, 6, and 11."
510503|NCT00321984|B4|Baseline|Total|Total of all reporting groups
510504|NCT00321984|B3|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510505|NCT00321984|B2|Baseline|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510506|NCT00321984|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510511|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510512|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510513|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510514|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510515|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510516|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510517|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510518|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510519|NCT00321984|O3|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510520|NCT00321984|O2|Outcome|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510521|NCT00321984|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510522|NCT00321984|E3|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
510523|NCT00321984|E2|Reported Event|Dexlansoprazole MR 30 mg QD|Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 4 weeks.
510524|NCT00321984|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
510525|NCT00321932|B3|Baseline|Total|Total of all reporting groups
510526|NCT00321932|B2|Baseline|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510527|NCT00321932|B1|Baseline|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510528|NCT00321932|P2|Participant Flow|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510529|NCT00321932|P1|Participant Flow|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510530|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510531|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510532|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510533|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510534|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510535|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510536|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510537|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510538|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510539|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510540|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510541|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510542|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510543|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510544|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV)( over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510545|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510546|NCT00321932|O2|Outcome|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid intravenously (IV) over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510547|NCT00321932|O1|Outcome|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510548|NCT00321932|E2|Reported Event|Arm II (Treatment With Zometa)|Patients receive vitamin D and calcium as in arm I. Patients also receive zoledronic acid IV over 15-30 minutes at 28 days prior to stem cell transplantation and at 3 and 6 months after transplantation.
510549|NCT00321932|E1|Reported Event|Arm I (Standard of Care)|Patients receive oral cholecalciferol (vitamin D) and oral calcium once a day for 12 months.
510551|NCT00321919|B2|Baseline|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510552|NCT00321919|B1|Baseline|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510553|NCT00321919|P2|Participant Flow|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL has occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510554|NCT00321919|P1|Participant Flow|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hemoglobin (Hb) level of 13-15 gram/decilitre (g/dL) with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510555|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510556|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510557|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510558|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510559|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510560|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510561|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510562|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510563|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510564|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510565|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510566|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510567|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510568|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510569|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510570|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510571|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510572|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510573|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510574|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months
510575|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510661|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510576|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510577|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510578|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510579|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510580|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510581|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510582|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510583|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510584|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510585|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510586|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510587|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510588|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510589|NCT00321919|O2|Outcome|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510590|NCT00321919|O1|Outcome|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510591|NCT00321919|E2|Reported Event|Late Epoetin Beta Therapy|Participants received epoetin beta treatment starting at 2000 IU, subcutaneously once weekly up to four years only when a decline in Hb levels to <10.5 g/dL had occurred in order to reach a target Hb of 10.5-11.5 g/dL.
510592|NCT00321919|E1|Reported Event|Early Epoetin Beta Therapy|Participants received immediate epoetin beta therapy starting at 2000 IU, subcutaneously once weekly up to four years to reach a target Hb level of 13-15 g/dL; with an individual Hb increase of at least 2 g/dL within approximately 3 months.
510593|NCT00321906|B3|Baseline|Total|Total of all reporting groups
510594|NCT00321906|B2|Baseline|Sirolimus|tacrolimus/sirolimus/prednisone
510595|NCT00321906|B1|Baseline|Azathioprine|(tacrolimus,azathioprine/prednisone)
510596|NCT00321906|P2|Participant Flow|Sirolimus|tacrolimus/sirolimus/prednisone
510597|NCT00321906|P1|Participant Flow|Azathioprine|(tacrolimus,azathioprine/prednisone)
510598|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510599|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510600|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510601|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510602|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510603|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510604|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510605|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510606|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510607|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510608|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510609|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510610|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510611|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510612|NCT00321906|O2|Outcome|Sirolimus|tacrolimus/sirolimus/prednisone
510613|NCT00321906|O1|Outcome|Azathioprine|(tacrolimus,azathioprine/prednisone)
510614|NCT00321906|E2|Reported Event|Sirolimus|tacrolimus/sirolimus/prednisone
510615|NCT00321906|E1|Reported Event|Azathioprine|(tacrolimus,azathioprine/prednisone)
510616|NCT00321893|B3|Baseline|Total|Total of all reporting groups
510617|NCT00321893|B2|Baseline|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510620|NCT00321893|P1|Participant Flow|Arm I: Budesonide|Inhaled Budesonide 800 micrograms (ug) twice daily for 1 year
510621|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510622|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510623|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510624|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510625|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510626|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510627|NCT00321893|O2|Outcome|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510628|NCT00321893|O1|Outcome|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510629|NCT00321893|E2|Reported Event|Arm II: Placebo|Inhaled placebo twice daily for 1 year
510630|NCT00321893|E1|Reported Event|Arm I: Budesonide|Inhaled Budesonide 800 ug twice daily for 1 year
510631|NCT00321854|B3|Baseline|Total|Total of all reporting groups
510632|NCT00321854|B2|Baseline|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510633|NCT00321854|B1|Baseline|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510634|NCT00321854|P2|Participant Flow|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
510635|NCT00321854|P1|Participant Flow|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
510636|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
510637|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
510638|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
510639|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
510640|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
510641|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
510642|NCT00321854|O2|Outcome|Delayed Pramipexole|Patients initially randomized to placebo, received placebo for 6-9 months, then up-titrated from 0.375 mg pramipexole daily to 1.5 mg pramipexole daily over a 6 week period. These patients were then continued on 1.5 mg pramipexole daily for the remainder of the 15 months of the study.
510643|NCT00321854|O1|Outcome|Early Pramipexole|Patients initially randomized to pramipexole were up-titrated from 0.375 mg pramipexole daily to 0.75 mg pramipexole daily and then to 1.5 mg pramipexole daily over a 6 week period, and then 1.5 mg pramipexole daily was continued for the remainder of the 15 months of the study.
510644|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510645|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510646|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510647|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510648|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510649|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510650|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510651|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510652|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510653|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510654|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510655|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510656|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510657|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510658|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510659|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510660|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
516756|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
510662|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510663|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510664|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510665|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510666|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510667|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510668|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510669|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510670|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510671|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510672|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510673|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510674|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510675|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510676|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510677|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510678|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510679|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510680|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510681|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510682|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510683|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510684|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510685|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510686|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510687|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510688|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510689|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510690|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510691|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510692|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510693|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510694|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510695|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510696|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510697|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510698|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510699|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510700|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510701|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510702|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510703|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510704|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510705|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510706|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510707|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510708|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510709|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510710|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510711|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510712|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510713|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510714|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510715|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510716|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510717|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510718|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510719|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510720|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510721|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510722|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510723|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510724|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510725|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510726|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510727|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510728|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510729|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510730|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510731|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510732|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510733|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510734|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510735|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510736|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510737|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510738|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510739|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510740|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510741|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510742|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510743|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510744|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510745|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510746|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510747|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510748|NCT00321854|O2|Outcome|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510749|NCT00321854|O1|Outcome|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510750|NCT00321854|E2|Reported Event|Delayed Pramipexole|Placebo (for first 6 to 9 months) + 1.5 milligrams/day pramipexole (for following 6 months)
510751|NCT00321854|E1|Reported Event|Early Pramipexole|1.5 milligrams/day pramipexole (for up to 15 months)
510752|NCT00321828|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
510753|NCT00321828|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
510754|NCT00321828|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
510755|NCT00321828|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
510756|NCT00321269|B3|Baseline|Total|Total of all reporting groups
510757|NCT00321269|B2|Baseline|8-Week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
510758|NCT00321269|B1|Baseline|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
510759|NCT00321269|P2|Participant Flow|8-week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
510760|NCT00321269|P1|Participant Flow|8-week Phone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
510761|NCT00321269|O2|Outcome|8-Week Phone-Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
511057|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
510762|NCT00321269|O1|Outcome|8-Week Phone-Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
510763|NCT00321269|O2|Outcome|8-week Phone-based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
510764|NCT00321269|O1|Outcome|8-week Phone-based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
510765|NCT00321269|E2|Reported Event|8-Week Phone Based Comorbid Illness Management|"Nursing intervention to treat Congestive Heart Failure and emotional coping~CHF and emotional coping: 8 week nursing intervention to address Congestive Heart Failure and emotional coping"
510766|NCT00321269|E1|Reported Event|8-week Telephone Based Single Illness Management|"Standard nursing intervention to treat Congestive Heart Failure~Education & behavioral techniques to help CHF patients cope with chronic illness: 8 week nursing intervention addressing Congestive Heart Failure"
510767|NCT00320801|B3|Baseline|Total|Total of all reporting groups
510768|NCT00320801|B2|Baseline|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
510769|NCT00320801|B1|Baseline|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
510770|NCT00320801|P4|Participant Flow|Extension Phase|Subjects received open-label buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear for up to 52 weeks.
510771|NCT00320801|P3|Participant Flow|Double-blind BTDS 20|Test treatment: buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
510772|NCT00320801|P2|Participant Flow|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
510773|NCT00320801|P1|Participant Flow|Run-in Period|(≤14 days). The run-in period was designed to select subjects who tolerated and responded to BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
510774|NCT00320801|O4|Outcome|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
510775|NCT00320801|O3|Outcome|Run-in Period|The run-in period was designed to determine tolerability of BTDS 20. Subjects were eligible to enter the double-blind phase if they tolerated BTDS 20 and achieved stable analgesia.
510776|NCT00320801|O2|Outcome|Double-blind BTDS 20|Test treatment: Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
510777|NCT00320801|O1|Outcome|Double-blind BTDS 5|Reference treatment: Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
510778|NCT00320801|E4|Reported Event|Overall BTDS Exposure|Overall core and extension phase combined (run-in period, double-blind phase, and extension phase)
510779|NCT00320801|E3|Reported Event|Open-label Run-in Period|The run-in period (14 days) was designed to identify subjects whose pain was controlled with and who tolerated BTDS 20. Open-label BTDS 10 or 20 mcg/h applied for 7-day wear to qualify for randomization into the double-blind phase.
510780|NCT00320801|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
510781|NCT00320801|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
510782|NCT00320788|B6|Baseline|Total|Total of all reporting groups
510783|NCT00320788|B5|Baseline|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510784|NCT00320788|B4|Baseline|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510785|NCT00320788|B3|Baseline|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510786|NCT00320788|B2|Baseline|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510787|NCT00320788|B1|Baseline|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510788|NCT00320788|P5|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 4.0mg q12|Participants received 4.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
510789|NCT00320788|P4|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q12|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
510790|NCT00320788|P3|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 2.0mg q4|Participants received 2.0 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
510791|NCT00320788|P2|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q12|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 12 week intervals through Week 12.
510792|NCT00320788|P1|Participant Flow|Aflibercept Injection (VEGF Trap-Eye, BAY86-5321) 0.5mg q4|Participants received 0.5 mg of aflibercept injection (VEGF Trap-Eye, BAY86-5321) at 4 week intervals through Week 12.
510793|NCT00320788|O6|Outcome|Total|
510794|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510795|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510796|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510797|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510798|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510799|NCT00320788|O6|Outcome|Total|
510800|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
510801|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
511210|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
510802|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
510803|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510804|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510805|NCT00320788|O6|Outcome|Total|
510806|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510807|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510808|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510809|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510810|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510811|NCT00320788|O6|Outcome|Total|
510812|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510813|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510814|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510815|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510816|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510817|NCT00320788|O6|Outcome|Total|
510818|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0mg of aflibercept injection at 12 week intervals through Week 12.
510819|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0mg of aflibercept injection at 12 week intervals through Week 12.
510820|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0mg of aflibercept injection at 4 week intervals through Week 12.
510821|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5mg of aflibercept injection at 12 week intervals through Week 12.
510822|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5mg of aflibercept injection at 4 week intervals through Week 12.
510823|NCT00320788|O6|Outcome|Total|
510824|NCT00320788|O5|Outcome|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510825|NCT00320788|O4|Outcome|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510826|NCT00320788|O3|Outcome|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510827|NCT00320788|O2|Outcome|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510828|NCT00320788|O1|Outcome|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510829|NCT00320788|E5|Reported Event|Aflibercept Injection 4.0mg q12|Participants received 4.0 mg of aflibercept injection at 12 week intervals through Week 12.
510830|NCT00320788|E4|Reported Event|Aflibercept Injection 2.0mg q12|Participants received 2.0 mg of aflibercept injection at 12 week intervals through Week 12.
510831|NCT00320788|E3|Reported Event|Aflibercept Injection 2.0mg q4|Participants received 2.0 mg of aflibercept injection at 4 week intervals through Week 12.
510832|NCT00320788|E2|Reported Event|Aflibercept Injection 0.5mg q12|Participants received 0.5 mg of aflibercept injection at 12 week intervals through Week 12.
510833|NCT00320788|E1|Reported Event|Aflibercept Injection 0.5mg q4|Participants received 0.5 mg of aflibercept injection at 4 week intervals through Week 12.
510834|NCT00320749|B1|Baseline|Capecitabine, Gemcitabine and Docetaxel|Docetaxel i.v. over 30 min on days 1 and 8; Capecitabine p.o. in split doses bid on days 8-21, Gemcitabine i.v. over 75 min on days 8 and 15.
510835|NCT00320749|P3|Participant Flow|Dose Level 3|Docetaxel at 36 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
510836|NCT00320749|P2|Participant Flow|Dose Level 2|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 625 mg/m2/12 hours on days 8-21
510837|NCT00320749|P1|Participant Flow|Dose Level 1|Docetaxel at 30 mg/m2 on days 1 and 8, Gemcitabine at 750 mg/m2 (over 75 minutes) on days 8 and 15 and capecitabine at 500 mg/m2/12 hours on days 8-21
510838|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
510839|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
510840|NCT00320749|O1|Outcome|Capecitabine, Docetaxel, Gemcitabine|"Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capecitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.~Capecitabine: Will be give on days 8-21~Docetaxel: Will be given on days 1 and 8,~Gemcitabine: A fixed dose rate will be give on days 8 and 15."
510912|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510841|NCT00320749|E1|Reported Event|Capecitabine, Docetaxel, Gemcitabine|Dose escalation study of mGTX using three dose levels (DL1-3). Patients received docetaxel on days 1 and 8, gemcitabine on days 8 and 15, and capcitabine on days 8 through 21. Gemcitabine fixed dose at 750 mg/m2 over 75 min, capecitabine twice daily and escalated from 500 to 650 mg/m2 at DL2 and docetaxel increased from 30 to 36 mg/m2 at DL3.
510842|NCT00320710|B4|Baseline|Total|Total of all reporting groups
510843|NCT00320710|B3|Baseline|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
510844|NCT00320710|B2|Baseline|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510845|NCT00320710|B1|Baseline|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510846|NCT00320710|P3|Participant Flow|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
510847|NCT00320710|P2|Participant Flow|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510848|NCT00320710|P1|Participant Flow|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510849|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510850|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510851|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510852|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510853|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510854|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510855|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510856|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510857|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510858|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510859|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510860|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510861|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510862|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510863|NCT00320710|O2|Outcome|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510864|NCT00320710|O1|Outcome|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510865|NCT00320710|E3|Reported Event|Placebo / Zoledronic Acid|Participants randomized to this arm received placebo but the arm was later dropped and participants in this arm were later switched to the zoledronic acid q 4 weeks according to a study amendment.
510866|NCT00320710|E2|Reported Event|Zoledronic Acid q 12 Weeks|Participants received 4 mg zoledronic acid IV q 12 weeks and received placebo to Zometa IV at the 4 week intervals between the q 12 week zoledronic acid infusions in order to maintain the blind.
510867|NCT00320710|E1|Reported Event|Zoledronic Acid Every (q) 4 Weeks|Participants received 4mg of zoledronic acid intravenously (IV) infusion q 4 weeks.
510868|NCT00320671|B3|Baseline|Total|Total of all reporting groups
510869|NCT00320671|B2|Baseline|Participants Will Take Risperidone|"Participants will take risperidone~Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end."
510870|NCT00320671|B1|Baseline|Participants Will Take Aripiprazole|"Participants will take aripiprazole~Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end."
510871|NCT00320671|P2|Participant Flow|Participants Will Take Risperidone Arm 2|-96 participants were randomized to to Arm 2
510872|NCT00320671|P1|Participant Flow|Participants Will Take Aripiprazole Arm 1|-102 were allocated to Arm 1.
510936|NCT00320528|B1|Baseline|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510873|NCT00320671|O2|Outcome|Percentage of Participants That Reposonded to Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
510874|NCT00320671|O1|Outcome|Percentage of Participants That Reposonded to Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
510875|NCT00320671|E2|Reported Event|Participants Will Take Risperidone|Risperidone: The dosage for risperidone will be 1 mg to 6 mg per day in capsule form. The dose of risperidone will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks, then every 2 weeks until the 12th week, and then monthly until the study end.
510876|NCT00320671|E1|Reported Event|Participants Will Take Aripiprazole|Aripiprazole: The dosage for aripiprazole will be 5 mg to 30 mg per day in capsule form. The dose of aripiprazole will be based on the participant's clinical improvement and side effects, which will be evaluated weekly for the first 4 weeks and then every 2 weeks until the 12th week and then monthly until study end.
510877|NCT00320606|B1|Baseline|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
510878|NCT00320606|P1|Participant Flow|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
510879|NCT00320606|O1|Outcome|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
510880|NCT00320606|E1|Reported Event|Immunosuppression Withdrawal Arm|Subjects will be tapered off of their single immunosuppression drug (cyclosporine or tacrolimus)
510881|NCT00320593|B3|Baseline|Total|Total of all reporting groups
510882|NCT00320593|B2|Baseline|Single Vision Lenses (SVLs)|Standard single vision lenses
510883|NCT00320593|B1|Baseline|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510884|NCT00320593|P2|Participant Flow|Single Vision Lenses (SVLs)|Standard single vision lenses
510885|NCT00320593|P1|Participant Flow|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510886|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510887|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510888|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510889|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510890|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510891|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510892|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510893|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510894|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510895|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510896|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510897|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510898|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510899|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510900|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510901|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510902|NCT00320593|O2|Outcome|Single Vision Lenses (SVLs)|Standard single vision lenses
510903|NCT00320593|O1|Outcome|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510904|NCT00320593|E2|Reported Event|Single Vision Lenses (SVLs)|Standard single vision lenses
510905|NCT00320593|E1|Reported Event|Progressive Addition Lenses (PALs)|Varilux Ellipse progressive addition lenses (PALs) with a +2.00 D addition
510906|NCT00320541|B3|Baseline|Total|Total of all reporting groups
510907|NCT00320541|B2|Baseline|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510908|NCT00320541|B1|Baseline|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510909|NCT00320541|P2|Participant Flow|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510910|NCT00320541|P1|Participant Flow|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510911|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
511269|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
510913|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510914|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510915|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510916|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510917|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510918|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510919|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510920|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510921|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510922|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510923|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510924|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510925|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510926|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510927|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510928|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510929|NCT00320541|O2|Outcome|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510930|NCT00320541|O1|Outcome|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510931|NCT00320541|E2|Reported Event|Paclitaxel Plus Bevacizumab Plus Gemcitabine (PB+G)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by gemcitabine 1500 mg/m2 IV on days 1 and 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510932|NCT00320541|E1|Reported Event|Paclitaxel Plus Bevacizumab (PB)|paclitaxel 90 milligrams per meter squared (mg/m2) administered intravenously (IV) on days 1, 8, 15 every 28 days followed by bevacizumab 10 milligrams per kilogram (mg/kg) administered IV on days 1 and 15 every 28 days
510933|NCT00320528|B4|Baseline|Total|Total of all reporting groups
510934|NCT00320528|B3|Baseline|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510935|NCT00320528|B2|Baseline|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
516757|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
510937|NCT00320528|P3|Participant Flow|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510938|NCT00320528|P2|Participant Flow|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510939|NCT00320528|P1|Participant Flow|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510940|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510941|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510942|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510943|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510944|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510945|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510946|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510947|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510948|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510949|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510950|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510951|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510952|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510953|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510954|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510955|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510956|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510957|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510958|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510959|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510960|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510961|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510962|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510963|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510964|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510965|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510966|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510967|NCT00320528|O3|Outcome|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510968|NCT00320528|O2|Outcome|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510969|NCT00320528|O1|Outcome|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510970|NCT00320528|E3|Reported Event|ADHD+Externalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus externalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510971|NCT00320528|E2|Reported Event|ADHD+Internalizing Disorders|Attention-Deficit/Hyperactivity Disorder (ADHD) plus internalizing disorders. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510972|NCT00320528|E1|Reported Event|Pure ADHD|Attention-Deficit/Hyperactivity Disorder (ADHD) alone. Received atomoxetine: 0.5 milligrams per kilogram per day (mg/kg/day), by mouth (PO) for 1 week then 1.2 mg/kg/day, PO for 11 weeks followed by up to 1.4 mg/kg/day, PO for up to 12 additional weeks
510973|NCT00320515|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510974|NCT00320515|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510975|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510976|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510977|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510978|NCT00320515|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510979|NCT00320515|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 700 mg/m2, intravenous (IV), every 21 days, until disease progression Cisplatin: 75 mg/m2, intravenous (IV), every 21 days, until disease progression
510980|NCT00320489|B3|Baseline|Total|Total of all reporting groups
510981|NCT00320489|B2|Baseline|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510982|NCT00320489|B1|Baseline|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510983|NCT00320489|P2|Participant Flow|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510984|NCT00320489|P1|Participant Flow|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510985|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510986|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511270|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
510987|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510988|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510989|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510990|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510991|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510992|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510993|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510994|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510995|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510996|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510997|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
510998|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
510999|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511000|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511001|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511002|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511003|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511004|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511005|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511006|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511007|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511008|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511009|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511010|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511011|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511012|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511013|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511014|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511015|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511016|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511017|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511018|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511019|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511020|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511021|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511022|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511023|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511024|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511025|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511026|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511027|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511028|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511029|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511030|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511031|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511032|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511033|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511034|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511035|NCT00320489|O2|Outcome|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511036|NCT00320489|O1|Outcome|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511037|NCT00320489|E2|Reported Event|Oral Olanzapine|10 mg, oral tablets, once daily for 4 weeks followed by 5-20 mg flexible dosing, oral tablets, once daily, for 100 weeks, for a total treatment duration of 104 weeks.
511038|NCT00320489|E1|Reported Event|Olanzapine Pamoate Depot|405 mg, intramuscular injection, followed 4 weeks later by 150-405 mg flexible dosing, intramuscular injection, every 4 weeks thereafter for 96 weeks, for a total treatment duration of 104 weeks.
511039|NCT00320411|B1|Baseline|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511040|NCT00320411|P1|Participant Flow|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511041|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511042|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511043|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511044|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511045|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511046|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511047|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511048|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511049|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511050|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511051|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511052|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511053|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511054|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511055|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511056|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511058|NCT00320411|O1|Outcome|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511059|NCT00320411|E1|Reported Event|Lapatinib Monotherapy|Lapatinib: 1500 mg (six 250 mg tablets) orally once daily
511060|NCT00320385|B3|Baseline|Total|Total of all reporting groups
511061|NCT00320385|B2|Baseline|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511062|NCT00320385|B1|Baseline|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511063|NCT00320385|P2|Participant Flow|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511064|NCT00320385|P1|Participant Flow|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511065|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511066|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511067|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511068|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511069|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511070|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511071|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511072|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511073|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511074|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511075|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511076|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511077|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511078|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511079|NCT00320385|O2|Outcome|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511080|NCT00320385|O1|Outcome|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511081|NCT00320385|E2|Reported Event|Lapatinib|Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
511082|NCT00320385|E1|Reported Event|Trastuzumab + Lapatinib|Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
511083|NCT00320372|B4|Baseline|Total|Total of all reporting groups
511084|NCT00320372|B3|Baseline|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy. Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
511085|NCT00320372|B2|Baseline|VNS Therapy D-21 Rollover|Subjects that entered the TRD Registry, having previously participated in the D-21 study and still being treated with VNS Therapy treatment were included within the VNS Therapy group. Based on the duration from initial implant to enrollment date, the D-21 rollover patients entered at the appropriate D-23 follow-up interval (i.e., patient enrolls at 24 months post implant for their first D-23 follow up visit. This 24 month visit corresponds to the 24 month follow up in the TRD Registry). Starting with the first TRD Registry visit, the D-21 long-term patients were to follow the same data collection schedule as other Original VNS and TAU Registry patients.
511086|NCT00320372|B1|Baseline|VNS Therapy D-23 Original|Subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm.
511135|NCT00320255|B4|Baseline|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
516758|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
511087|NCT00320372|P2|Participant Flow|Treatment as Usual (TAU)|Disposition of study patients from baseline to the end of the study. The TAU arm were subjects that entered the TRD Registry without previous VNS Therapy treatment and selected the TAU study arm.
511088|NCT00320372|P1|Participant Flow|VNS Therapy|Disposition of study patients from baseline to the end of the study. The VNS Therapy arm, was comprised of D-23 Original patients (Patients that entered the TRD Registry without previous VNS Therapy treatment and selected the VNS Therapy study arm) and D-21 Rollover patients (Patients that entered the TRD Registry, having previously participated in the D-21 study-NCT00305565 and still being treated with VNS Therapy).
511089|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
511090|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
511091|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
511092|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Change from Baseline Score
511093|NCT00320372|O1|Outcome|VNS Therapy|Change from Baseline Score
511094|NCT00320372|O1|Outcome|ITT Population|VNS Therapy and Treatment as Usual (TAU)
511095|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
511096|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
511097|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
511098|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
511099|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
511100|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
511101|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
511102|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
511103|NCT00320372|O2|Outcome|Treatment as Usual (TAU)|Non-VNS Patients - Treatment-resistant depression patients not receiving VNS Therapy
511104|NCT00320372|O1|Outcome|VNS Therapy|VNS Patients - Treatment-resistant depression patients treated with VNS Therapy
511105|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Remitters (Percentage of Subjects in Remission)
511106|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Remitters (Percentage of Subjects in Remission)
511107|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|Time until recurrence based on the MADRS
511108|NCT00320372|O1|Outcome|VNS Therapy|Time until recurrence based on the MADRS
511109|NCT00320372|O2|Outcome|Treatment As Usual (TAU)|MADRS % Responders (Percentage of Responders)
511110|NCT00320372|O1|Outcome|VNS Therapy|MADRS % Responders (Percentage of Responders)
511111|NCT00320372|E1|Reported Event|Safety Events|N/A (not collected)
511112|NCT00319644|B3|Baseline|Total|Total of all reporting groups
511113|NCT00319644|B2|Baseline|Tracheal Aspirates|No intervention. Standard of care in ICU.
511114|NCT00319644|B1|Baseline|Minibal Arm|Using Mini bronchoalveolar lavage
511115|NCT00319644|P2|Participant Flow|Minibal Arm|Using Mini bronchoalveolar lavage
511116|NCT00319644|P1|Participant Flow|Tracheal Aspirates|No intervention. Standard of care in ICU.
511117|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
511118|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
511119|NCT00319644|O2|Outcome|Tracheal Aspirates|No intervention. Standard of care in ICU. the aspirates were sent for micro culture.
511120|NCT00319644|O1|Outcome|Mini-BAL|BAL for quantitative culture as TA group.
511121|NCT00319644|E2|Reported Event|Tracheal Aspirates|No intervention. Standard of care in ICU.
511122|NCT00319644|E1|Reported Event|Minibal Arm|Using Mini bronchoalveolar lavage
511123|NCT00320281|B3|Baseline|Total|Total of all reporting groups
511124|NCT00320281|B2|Baseline|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
511125|NCT00320281|B1|Baseline|Group 1-Botox A Group|This group received the active drug, botox a injections.
511126|NCT00320281|P2|Participant Flow|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
511127|NCT00320281|P1|Participant Flow|Group 1-Botox A Group|This group received the active drug, botox a injections.
511128|NCT00320281|O2|Outcome|Group 2-saline Group|Those randomized to this treatment group received injections based on treatment plan devised by study PI and study physical therapist. 25 cc of saline were used for these injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
511129|NCT00320281|O1|Outcome|Group 1-Botox A Group|Those randomized to this treatment group received injections based on treatment plan designed by PI and study physical therapist. Botulism toxin A was diluted in 25 cc of saline for the injections. Multiple injections may have occured during a single clinic visit based on pain/stiffness upon assesment by the study treatment team.
511130|NCT00320281|E2|Reported Event|Group 2-saline Group|Group 2 is the control group and received injections of saline instead of the saline plus botox A injections that the treatment group received
511131|NCT00320281|E1|Reported Event|Group 1-Botox A Group|This group received the active drug, botox a injections.
511132|NCT00320255|B7|Baseline|Total|Total of all reporting groups
511133|NCT00320255|B6|Baseline|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511134|NCT00320255|B5|Baseline|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511136|NCT00320255|B3|Baseline|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511137|NCT00320255|B2|Baseline|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511138|NCT00320255|B1|Baseline|Cohort 1: Placebo|Participants received placebo tablets once daily
511139|NCT00320255|P6|Participant Flow|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511140|NCT00320255|P5|Participant Flow|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511141|NCT00320255|P4|Participant Flow|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511142|NCT00320255|P3|Participant Flow|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511143|NCT00320255|P2|Participant Flow|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511144|NCT00320255|P1|Participant Flow|Cohort 1: Placebo|Participants received placebo tablets once daily
511145|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511146|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511147|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511148|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511149|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511150|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511151|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511152|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511153|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511154|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511155|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511156|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511157|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511158|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511159|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511160|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511161|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511162|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511163|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511164|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511165|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511166|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511167|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511168|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511169|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511170|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511171|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511172|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511173|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511174|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511175|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511176|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511177|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511178|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511179|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511180|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511181|NCT00320255|O6|Outcome|Cohort 2: Apixiban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511182|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511183|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511184|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511185|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511186|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511187|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511188|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511189|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511190|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511191|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511192|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511193|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511194|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511195|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511196|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511197|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511198|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511199|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511200|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511201|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511202|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511203|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511204|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511205|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511206|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511207|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511208|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511209|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511211|NCT00320255|O6|Outcome|Cohort 2: Apixaban, 5 mg|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511212|NCT00320255|O5|Outcome|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511213|NCT00320255|O4|Outcome|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511214|NCT00320255|O3|Outcome|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511215|NCT00320255|O2|Outcome|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511216|NCT00320255|O1|Outcome|Cohort 1: Placebo|Participants received placebo tablets once daily
511217|NCT00320255|E6|Reported Event|Cohort : Apixaban, 5 mg|:Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received apixaban as tablet, 5 mg, once daily.
511218|NCT00320255|E5|Reported Event|Cohort 2: Placebo|Participants in this cohort were admitted to the trial following the addition of a protocol amendment (Amendment 5), which removed the prohibition of inclusion of patients receiving chemotherapy with concomitant antiangiogenic therapy with bevacizumab. Patients received placebo once daily.
511219|NCT00320255|E4|Reported Event|Cohort 1: Apixaban, 20 mg|Participants received apixaban as tablet, 20 mg, once daily
511220|NCT00320255|E3|Reported Event|Cohort 1: Apixaban, 10 mg|Participants received apixaban as tablet, 10 mg, once daily
511221|NCT00320255|E2|Reported Event|Cohort 1: Apixaban, 5 mg|Participants received apixaban as tablet, 5 mg, once daily
511222|NCT00320255|E1|Reported Event|Cohort 1: Placebo|Participants received placebo tablets once daily
511223|NCT00320216|B6|Baseline|Total|Total of all reporting groups
511224|NCT00320216|B5|Baseline|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511225|NCT00320216|B4|Baseline|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511226|NCT00320216|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511227|NCT00320216|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511228|NCT00320216|B1|Baseline|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
511229|NCT00320216|P5|Participant Flow|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511230|NCT00320216|P4|Participant Flow|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511231|NCT00320216|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511232|NCT00320216|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511233|NCT00320216|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
511234|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511235|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511236|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511237|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511238|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
511239|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511271|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
516759|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
511240|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511241|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511242|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511243|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
511244|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511245|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511246|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511247|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511248|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
511249|NCT00320216|O5|Outcome|Group V: Ustekinumab 90 mg Weekly for 4 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511250|NCT00320216|O4|Outcome|Group IV: Ustekinumab 45 mg Weekly for 4 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511251|NCT00320216|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 90 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511252|NCT00320216|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Week 0 followed by placebo at Weeks 1, 2 and 3. At week 16, participants who had a Physician's Global Assessment (PGA) >=3 received 45 mg ustekinumab and participants with a PGA<3 received placebo. At week 20, all participants received placebo.
511253|NCT00320216|O1|Outcome|Group I: Placebo|Participants received placebo at Weeks 0, 1, 2 and 3. At week 16, all participants received placebo regardless of Physician's Global Assessment (PGA). At week 20, all participants received a single dose of ustekinumab 90 mg.
511254|NCT00320216|E10|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511255|NCT00320216|E9|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511256|NCT00320216|E8|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 90 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511257|NCT00320216|E7|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 20-36) - receiving ustekinumab 45 mg at Week 0. At Week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511258|NCT00320216|E6|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 20-36) - receiving placebo at Weeks 0, 1, 2, 3 and 16 -> receiving ustekinumab 90 mg at Week 20.
511259|NCT00320216|E5|Reported Event|Ustekinumab 90 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511260|NCT00320216|E4|Reported Event|Ustekinumab 45 mg Weekly for 4 Weeks (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0, 1, 2 and 3. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511261|NCT00320216|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 90 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 90 mg.
511262|NCT00320216|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-20) - receiving ustekinumab 45 mg at Weeks 0. At week 16, participants with PGA >= 3 received ustekinumab 45 mg.
511263|NCT00320216|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-20) - receiving placebo at Weeks 0, 1, 2, 3 and 16.
511264|NCT00320190|B3|Baseline|Total|Total of all reporting groups
511265|NCT00320190|B2|Baseline|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511266|NCT00320190|B1|Baseline|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511267|NCT00320190|P2|Participant Flow|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511268|NCT00320190|P1|Participant Flow|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511272|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511273|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511274|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511275|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511276|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511277|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511278|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511279|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511280|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511281|NCT00320190|O2|Outcome|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily.
511282|NCT00320190|O1|Outcome|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511283|NCT00320190|E2|Reported Event|Imatinib, 800 mg|Imatinib, 400 mg, administered orally twice daily
511284|NCT00320190|E1|Reported Event|Dasatinib, 100 mg|Dasatinib, 100 mg, administered orally once daily.
511285|NCT00320112|B3|Baseline|Total|Total of all reporting groups
511286|NCT00320112|B2|Baseline|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
511287|NCT00320112|B1|Baseline|Receiprocal Peer Support|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
511288|NCT00320112|P2|Participant Flow|Nurse Case Management|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts. particpants were also provided information about nurse case managements services and encouraged to use the service regularly.
511289|NCT00320112|P1|Participant Flow|Reciprocal Diabetes Peer Support Program (RPS)|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
511290|NCT00320112|O2|Outcome|Nurse Case Management Grouop|patients were provided an educational session and discussed nurse case management services. participants were encouraged to meet wit their case manager regularly.
511291|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|patients were age-matched and assigned to a peer. they were asked to make weekly calls using a telephone support system to check in and discuss their diabetes
511292|NCT00320112|O2|Outcome|Nurse Case Management Group|participants in the nurse case management group receive initial educational session on diabetes and information bout case management services. they are encouraged to contact their nurse case manager regularly.
511293|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|participants are age-matched with a peer and asked to talk with each other weekly using a telephone support sytem
511294|NCT00320112|O2|Outcome|Change in Systsolic at 6 Months for Nurse Mgt Group|change in systolic blood pressure from baseline to six months in the nurse case management group
511295|NCT00320112|O1|Outcome|Change in Systolic BP at 6 Months for Peer Support Group|change in systolic blood pressure from baseline to six months among participants in the peer support group
511296|NCT00320112|O2|Outcome|Nurse Case Management Group|Nurse Case Management group was offered an educational session with nurse case managers on diabetes and informed of case management services. they were encouraged to utilize this service regularly.
511297|NCT00320112|O1|Outcome|Reciprocal Peer Support Group|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
511298|NCT00320112|E2|Reported Event|Nurse Case Management Intervention|participants were randomized to receive usual care with an initial educational session to review lab results and discuss any questions related to educational handouts
511299|NCT00320112|E1|Reported Event|Reciprocal Peer Support Intervention|"participants in the intervention arm are paired with a peer~Peer-support telephone calls: peers are paired during the group visit and are encouraged to speak with their partner at least once a week for the 6 month duration of the study.~group outpatient counseling visits: participants are given the option to attend 3 optional group visits with other participants and case managers. this gives them the opportunity to ask any diabetes related questions of nurses or other participants who have diabetes."
511300|NCT00319982|B3|Baseline|Total|Total of all reporting groups
511301|NCT00319982|B2|Baseline|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511302|NCT00319982|B1|Baseline|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511303|NCT00319982|P2|Participant Flow|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511304|NCT00319982|P1|Participant Flow|I- Diltiazem (Active Arm)|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511305|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511306|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511307|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511308|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511309|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511310|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511311|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511312|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511313|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511314|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511315|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511316|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511317|NCT00319982|O2|Outcome|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511318|NCT00319982|O1|Outcome|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511319|NCT00319982|E2|Reported Event|II- Placebo|"Placebo Comparator~Placebo: Placebo comparator (double-blind allocation of study medication)"
511320|NCT00319982|E1|Reported Event|I- Diltiazem|Diltiazem: Titrated to a target dose of 360 mg daily (sustained release formulation) for the duration of the study period
511321|NCT00319748|B1|Baseline|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
511322|NCT00319748|P1|Participant Flow|Patients Treated With 852A|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
511323|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of TNF-a in patients treated with 852A.
511324|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of sCD40L in patients treated with 852A.
511325|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of MIP-1b in patients treated with 852A.
511326|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for Macrophage Inflammatory Protein-1 Alpha (cytokine) level in patients treated with 852A.
511327|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IP-10 in patients treated with 852A.
511328|NCT00319748|O1|Outcome|Patients Treated With 852A|Difference in range values from pre-treatment to post-treatment for cytokine level of IL1ra in patients treated with 852A.
511329|NCT00319748|O1|Outcome|Patients With Ovarian Cancer|Participants with ovarian cancer who received all 24 doses of 852A.
511330|NCT00319748|E1|Reported Event|Patients Treated With 852A Study Drug|Patients that received at least one dose of study treatment with 852A (0.6 mg/m^2 to 1.2 mg/m^2 dose, 2 times/week for 12 weeks).
511331|NCT00319735|B1|Baseline|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511332|NCT00319735|P1|Participant Flow|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511333|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511334|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511489|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
511335|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511336|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511337|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511338|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511339|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511340|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511341|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511342|NCT00319735|O1|Outcome|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36 Combined with radiation therapy for six weeks. Surgical esophageal resection after 6 to 8 week rest period.~Subjects who consent will provide tissue samples.~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511384|NCT00319592|E1|Reported Event|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511385|NCT00319553|B3|Baseline|Total|Total of all reporting groups
511386|NCT00319553|B2|Baseline|Boostrix® Vaccine Group|
511387|NCT00319553|B1|Baseline|Adacel® Vaccine Group|
511388|NCT00319553|P2|Participant Flow|Boostrix® Vaccine Group|
511389|NCT00319553|P1|Participant Flow|Adacel® Vaccine Group|
511390|NCT00319553|O2|Outcome|Boostrix® Vaccine Group|
511343|NCT00319735|E1|Reported Event|Single Arm Assignment|"Cetuximab 400 mg/m2 IV over 120 minutes Day -14 (Loading Dose) Cetuximab 250 mg/m2 IV over 60 minutes Day -7 Cetuximab 250 mg/m2 IV over 60 minutes Days 1, 8, 15, 22, 29 and 36~Radiation Therapy: External beam radiation therapy, beginning on day 1, 4500 cGy to esophagus with boost of 540 cGy at 180 cGy per fraction for 6 weeks~Surgery: Surgical resection of primary tumor and adjacent mediastinal and/or celiac lymph nodes by a transthoracic approach after satisfactory hematologic and functional recovery within 8 weeks of completion of radiation therapy~Tissue Sample: For patients who give their consent, fresh frozen tissue will be obtained per EUS at baseline, per EUS 2 weeks after the initiation of chemotherapy, and at the time of surgery for pathology submission"
511344|NCT00319696|B1|Baseline|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511345|NCT00319696|P1|Participant Flow|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511346|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511347|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511348|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511349|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511350|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511351|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511352|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511353|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511354|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511355|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511356|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511357|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511358|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511359|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511360|NCT00319696|O1|Outcome|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511361|NCT00319696|O6|Outcome|At Least 5 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511362|NCT00319696|O5|Outcome|At Least 4 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511363|NCT00319696|O4|Outcome|At Least 3 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511364|NCT00319696|O3|Outcome|At Least 2 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511365|NCT00319696|O2|Outcome|At Least 1 New Ulcer|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511366|NCT00319696|O1|Outcome|0 New Ulcers|Number of new DUs includes the new number at each visit and the transient ulcers between visits.
511367|NCT00319696|E1|Reported Event|Bosentan|Initial dose: bosentan 62.5 mg twice daily (b.i.d.) for the first 4 weeks. Target dose: bosentan 125 mg b.i.d. thereafter
511368|NCT00319592|B3|Baseline|Total|Total of all reporting groups
511369|NCT00319592|B2|Baseline|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511370|NCT00319592|B1|Baseline|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511371|NCT00319592|P2|Participant Flow|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511372|NCT00319592|P1|Participant Flow|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511373|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511374|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511375|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511376|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511377|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511378|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511379|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511380|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511381|NCT00319592|O2|Outcome|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511382|NCT00319592|O1|Outcome|ChimeriVax™-JE After Placebo|Subjects received 2 injections of placebo (normal saline), 1 each on Days 0 and 7, and 1 injection of ChimeriVax™-JE on Day 28.
511383|NCT00319592|E2|Reported Event|JE-VAX®|Subjects received 1 injection of JE-VAX® each on Days 0, 7, and 28.
511401|NCT00319501|B2|Baseline|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511402|NCT00319501|B1|Baseline|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
511403|NCT00319501|P2|Participant Flow|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511404|NCT00319501|P1|Participant Flow|Diazepam|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible as needed during the Open-label and Open-label Extension Periods.
511405|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
511406|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
511407|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
511408|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
511409|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS). Additional doses were permissible during this period.
511410|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511411|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511412|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511413|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511414|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511415|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511416|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511417|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511418|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511476|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511419|NCT00319501|O1|Outcome|Diazepam|Participants received an age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511420|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511421|NCT00319501|O2|Outcome|Placebo|During the Double-blind Period, participants received a single, age- and weight-appropriate dose of placebo solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511422|NCT00319501|O1|Outcome|Diazepam|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of acute repetitive seizures (ARS).
511423|NCT00319501|E4|Reported Event|Placebo (Double-blind Period)|Participants received a single dose of diazepam-matching solution as a deep intramuscular injection in the mid to outer thigh. Drug was administered by a caregiver using a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511424|NCT00319501|E3|Reported Event|Diazepam (Open-label Extension)|Participants continued to receive diazepam in an age- and weight-appropriate dose of administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed at the onset of an ARS episode. Participants were to continue until drug became marketed.
511425|NCT00319501|E2|Reported Event|Diazepam (Open-label Period)|Participants received an age- and weight-appropriate dose of placebo solution administered using a spring-driven, pressure-activated, prefilled autoinjector. Additional doses were permissible as needed.
511426|NCT00319501|E1|Reported Event|Diazepam (Double-blind Period)|Participants received a single, age- and weight-appropriate dose of diazepam solution, ranging from 0.2 to 0.5 mg/kg, administered by caregivers untrained as and unsupervised by healthcare professionals. Drug was delivered by a spring-driven, pressure-activated, prefilled autoinjector at the onset of an episode of ARS.
511427|NCT00319449|B3|Baseline|Total|Total of all reporting groups
511428|NCT00319449|B2|Baseline|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511429|NCT00319449|B1|Baseline|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511430|NCT00319449|P2|Participant Flow|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511431|NCT00319449|P1|Participant Flow|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511432|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511433|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511434|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511435|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511436|NCT00319449|O2|Outcome|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511437|NCT00319449|O1|Outcome|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511438|NCT00319449|E2|Reported Event|Placebo 10 mg|Participants treated with 10 mg/day matching placebo to ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511439|NCT00319449|E1|Reported Event|Ezetimibe 10 mg|Participants treated with 10 mg/day ezetimibe added to an ongoing treatment of 10 mg/day atorvastatin.
511440|NCT00319436|B3|Baseline|Total|Total of all reporting groups
511441|NCT00319436|B2|Baseline|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511442|NCT00319436|B1|Baseline|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
511477|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511478|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511443|NCT00319436|P2|Participant Flow|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511444|NCT00319436|P1|Participant Flow|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511445|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511446|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511447|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511448|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511449|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511479|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511480|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511481|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511482|NCT00319111|O1|Outcome|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511450|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511451|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511452|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511453|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511454|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511455|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511456|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511483|NCT00319111|E1|Reported Event|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511484|NCT00319046|B1|Baseline|Miglustat|miglustat oral capsules 100mg three times a day
511485|NCT00319046|P1|Participant Flow|Miglustat|miglustat oral capsules 100mg three times a day
511486|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
511487|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
511488|NCT00319046|O1|Outcome|Miglustat|miglustat oral capsules 100mg three times a day
511457|NCT00319436|O2|Outcome|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511458|NCT00319436|O1|Outcome|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child's emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child's emotional needs.
511459|NCT00319436|E2|Reported Event|Standard Parent Education|This 12 session comparison intervention was designed to match the Maternal Mentalizing Therapy on time spent with the counselor and maternal expectations for help with parenting. PE counselors helped mothers get connected to services (e.g. medical and pediatric care, child care and child guidance services, housing assistance, vocational training), solve problems of daily living and make parenting-related decisions. PE mothers also received a pamphlet each week on a parenting topic of their choice. Pamphlets focused on common issues in caring for infants (e.g., soothing a crying baby, managing bedtime routines, and establishing routines ) and toddlers (e.g., helping toddlers dress, managing bedtime battles, managing difficult behavior in public, and setting limits without using punishment). Pamphlets provided behavioral guidance at a 5th grade reading level without reference to underlying mental states or emotional needs.
511460|NCT00319436|E1|Reported Event|Mentalizing Therapy for Mothers|This 12 session individual therapy aims to enhance maternal reflective functioning and soften harsh and distorted mental representations about the child. The intervention adopts a developmental progression based on attachment theory, supporting the mother in her parenting role and offering assistance with basic needs. Mothers are encouraged to reflect on their thoughts and feelings and how they affect behavior. The therapist assists mother's thinking about representations of herself as a parent and encourages her to explore opportunities for new understanding of her emotional needs. Therapist and mother explore representations of her child and their relationship in detail in order to understand their meaning and promote more balanced representations and affect regulation. Therapist and mother also explore child’s emotional experiences underlying behavior. The goal is to support the mother in becoming more aware of her child’s emotional needs.
511461|NCT00319254|B1|Baseline|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511462|NCT00319254|P1|Participant Flow|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511463|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511464|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511465|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511466|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511467|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511468|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511469|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511470|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511471|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511472|NCT00319254|O1|Outcome|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511473|NCT00319254|E1|Reported Event|Bosutinib|Four bosutinib 100 milligram (mg) capsules, equivalent to 400 mg bosutinib orally once daily for 48 weeks, or until disease progression, unacceptable toxicity or withdrawal of consent occurred.
511474|NCT00319111|B1|Baseline|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511475|NCT00319111|P1|Participant Flow|Bosentan|"Oral bosentan~Initial dose: 62.5 mg twice a day (b.i.d.) for 4 weeks for all patients~Maintenance dose: 125 mg b.i.d. (62.5 mg b.i.d. if weight < 40 kg)"
511490|NCT00319046|E1|Reported Event|Miglustat|miglustat oral capsules 100mg three times a day
511491|NCT00318929|B1|Baseline|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
511492|NCT00318929|P1|Participant Flow|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
511493|NCT00318929|O1|Outcome|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
511494|NCT00318929|E1|Reported Event|Depakote ER|Dosing regimen from 750 to 1250 mg once a day.
511495|NCT00318812|B3|Baseline|Total|Total of all reporting groups
511496|NCT00318812|B2|Baseline|Iron Sucrose|Iron Sucrose q month IV x 6 months
511497|NCT00318812|B1|Baseline|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511498|NCT00318812|P2|Participant Flow|Iron Sucrose|Iron Sucrose q month IV x 6 months
511499|NCT00318812|P1|Participant Flow|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511500|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
511501|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511502|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
511503|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511504|NCT00318812|O2|Outcome|Iron Sucrose|Iron Sucrose q month IV x 6 months
511505|NCT00318812|O1|Outcome|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511506|NCT00318812|E2|Reported Event|Iron Sucrose|Iron Sucrose q month IV x 6 months
511507|NCT00318812|E1|Reported Event|Heme Iron|Heme Iron Polypeptide 11mg PO tid for 6 months
511508|NCT00318708|B3|Baseline|Total|Total of all reporting groups
511509|NCT00318708|B2|Baseline|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
511510|NCT00318708|B1|Baseline|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
511511|NCT00318708|P2|Participant Flow|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
511512|NCT00318708|P1|Participant Flow|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
511513|NCT00318708|O2|Outcome|Placebo + Fluticasone|placebo clarithromycin + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
511514|NCT00318708|O1|Outcome|Clarithromycin + Fluticasone|clarithromycin 500 mg twice daily (Biaxin) + fluticasone propionate 88 mcg twice daily (Flovent® HFA 44 mcg two puffs twice daily)
511515|NCT00318708|E2|Reported Event|Placebo + Fluticasone|Fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
511516|NCT00318708|E1|Reported Event|Clarithromycin + Fluticasone|Clarithromycin 500 mg bid (Biaxin) + fluticasone propionate 88 mcg bid (Flovent® HFA 44 mcg two puffs bid)
511517|NCT00318656|B3|Baseline|Total|Total of all reporting groups
511518|NCT00318656|B2|Baseline|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511519|NCT00318656|B1|Baseline|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511520|NCT00318656|P2|Participant Flow|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511521|NCT00318656|P1|Participant Flow|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of Rosiglitazone (RSG) and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511522|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511523|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511537|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511618|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511524|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511525|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511526|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511527|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511528|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511529|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511530|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511531|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511532|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511533|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511534|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511535|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511536|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511538|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511539|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511540|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511541|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511542|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511543|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511544|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511545|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511546|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511547|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511548|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511549|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511550|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511551|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511552|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511553|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511554|NCT00318656|O2|Outcome|Glimepiride/Metformin|"Metformin will used at a daily dose of 2g, i.e. two 500mg tablet twice daily throughout the study~Glimepiride will be initiated at a dose of 1mg/day, i.e. half a 2mg tablet od; then, every 2 weeks, the daily dose will be uptitrated up to 4mg/day or until the maximal tolerated dose, using the following pattern:~from visit 5 to visit 6: 1mg once a day (half 2mg tablet) before or during breakfast or the first mean meal~from visit 6 to visit 7: 2mg once a day (one 2mg tablet) before or during breakfast or the first mean meal~from visit 7 to visit 8: 3mg once a day (one and half 2mg tablets) before or during breakfast or the first mean meal~from visit 8 onward: 4mg once a day (two 2mg tablet) before or during breakfast or the first mean meal."
511555|NCT00318656|O1|Outcome|Avandamet® (Rosiglitazone/Metformin)|Fixed-dose combination will be started at a dose of 4mg/day of RSG and 2g/day of metformin, i.e. two 1mg/500mg tablets twice daily. After 8 weeks of treatment, the daily dose will be increased to 8mg of RSG and 2g of metformin, i.e. two 2mg/500mg tablets twice daily.
511556|NCT00318591|B3|Baseline|Total|Total of all reporting groups
511557|NCT00318591|B2|Baseline|Conveen Uncoated|Uncoated intermittent catheter
511558|NCT00318591|B1|Baseline|SpeediCath|Hydrophilic coated intermittent catheter
511559|NCT00318591|P2|Participant Flow|Conveen Uncoated|Uncoated intermittent catheter
511560|NCT00318591|P1|Participant Flow|SpeediCath|Hydrophilic coated intermittent catheter
511561|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511562|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
511563|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511564|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
511565|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511566|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
511567|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511568|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
511569|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511570|NCT00318591|O1|Outcome|SpeediCath|Hydrophilic coated intermittent catheter
511571|NCT00318591|O2|Outcome|Conveen Uncoated|Uncoated intermittent catheter
511572|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
511573|NCT00318591|O2|Outcome|Conveen Uncoated|uncoated intermittent catheter
511574|NCT00318591|O1|Outcome|SpeediCath Catheter|Hydrophilic coated intermittent catheter
511575|NCT00318591|E2|Reported Event|Conveen Uncoated|Uncoated intermittent catheter
511576|NCT00318591|E1|Reported Event|SpeediCath|Hydrophilic coated intermittent catheter
511577|NCT00318565|B1|Baseline|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
511578|NCT00318565|P1|Participant Flow|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
511579|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
511580|NCT00318565|O1|Outcome|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
511581|NCT00318565|E1|Reported Event|Ablation Group|Subjects to undergo ablation with the NaviStar ThermoCool catheter for the treatment of typical atrial flutter.
511582|NCT00318474|B3|Baseline|Total|Total of all reporting groups
511583|NCT00318474|B2|Baseline|Placebo|Subjects receive ACEi and FOS and placebo.
511584|NCT00318474|B1|Baseline|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
511585|NCT00318474|P2|Participant Flow|Placebo|Subjects receive ACEi and FOS and placebo.
511586|NCT00318474|P1|Participant Flow|Mycophenolate Mofetil (MMF)|"Subjects receive angiotensin-converting enzyme inhibitors (ACEi), fish oil supplements (FOS), and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
511587|NCT00318474|O2|Outcome|Placebo|Subjects receive ACEi and FOS and placebo.
511588|NCT00318474|O1|Outcome|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
511589|NCT00318474|E2|Reported Event|Placebo|Subjects receive ACEi and FOS and placebo.
511975|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511590|NCT00318474|E1|Reported Event|Mycophenolate Mofetil (MMF)|"Subjects receive ACEi, FOS, and MMF. Dose is based on body size (between 25mg/kg/day and 36mg/kg/day with a maximum dose 1gm BID; initial dose to be used in the first 2 weeks of therapy will be approximately 1/2-2/3 of the full dose). Route of administration is oral. Frequency is daily. MMF will be administered up to 12 months.~Mycophenolate Mofetil (MMF)"
511591|NCT00318461|B6|Baseline|Total|Total of all reporting groups
511592|NCT00318461|B5|Baseline|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511593|NCT00318461|B4|Baseline|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511594|NCT00318461|B3|Baseline|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511595|NCT00318461|B2|Baseline|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511596|NCT00318461|B1|Baseline|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511597|NCT00318461|P5|Participant Flow|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511598|NCT00318461|P4|Participant Flow|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511599|NCT00318461|P3|Participant Flow|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511600|NCT00318461|P2|Participant Flow|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511601|NCT00318461|P1|Participant Flow|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511602|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511603|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511604|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511605|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511606|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511607|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511608|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511609|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511610|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511611|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511612|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511613|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511614|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511615|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511616|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511617|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511873|NCT00317044|P1|Participant Flow|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511619|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511620|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511621|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511622|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511623|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511624|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511625|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511626|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511627|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511628|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511629|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511630|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511631|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511632|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511633|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511634|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511635|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511636|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511637|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511638|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511639|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511640|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511641|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511642|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511643|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511644|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511645|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511646|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511874|NCT00317044|O3|Outcome|Placebo|Placebo
511976|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511647|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511648|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511649|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511650|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511651|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511652|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511653|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511654|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511655|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511656|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511657|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511658|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511659|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511660|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511661|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511662|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511663|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511664|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511665|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511666|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511667|NCT00318461|O5|Outcome|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511668|NCT00318461|O4|Outcome|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511669|NCT00318461|O3|Outcome|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511670|NCT00318461|O2|Outcome|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511671|NCT00318461|O1|Outcome|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511672|NCT00318461|E5|Reported Event|Met + Glim|Glimepiride 4 mg/day + metformin 1.5-2.0 g/day + liraglutide placebo, weeks 0-26 (double-blinded period) and open-label glimepiride 4 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511673|NCT00318461|E4|Reported Event|Met Mono|Metformin 1.5-2.0 g/day + liraglutide placebo + glimepiride placebo, weeks 0-26 (double-blinded period) and open-label metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511674|NCT00318461|E3|Reported Event|Lira 1.8 + Met|Liraglutide 1.8 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.8 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511875|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511675|NCT00318461|E2|Reported Event|Lira 1.2 + Met|Liraglutide 1.2 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 1.2 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511676|NCT00318461|E1|Reported Event|Lira 0.6 + Met|Liraglutide 0.6 mg/day + glimepiride placebo + metformin 1.5-2.0 g/day, weeks 0-26 (double-blinded period) and open-label liraglutide 0.6 mg/day + metformin 1.5-2.0 g/day in the extension period (weeks 26-104)
511677|NCT00318409|B3|Baseline|Total|Total of all reporting groups
511678|NCT00318409|B2|Baseline|Placebo|Placebo 300mg daily
511679|NCT00318409|B1|Baseline|Bupropion|Bupropion XL 300mg daily
511680|NCT00318409|P2|Participant Flow|Placebo|Placebo 300mg daily
511681|NCT00318409|P1|Participant Flow|Bupropion|Bupropion XL 300mg daily
511682|NCT00318409|O2|Outcome|Placebo|
511683|NCT00318409|O1|Outcome|Bupropion|
511684|NCT00318409|O2|Outcome|Placebo|
511685|NCT00318409|O1|Outcome|Bupropion|
511686|NCT00318409|O2|Outcome|Placebo|
511687|NCT00318409|O1|Outcome|Bupropion|
511688|NCT00318409|O2|Outcome|Placebo|
511689|NCT00318409|O1|Outcome|Bupropion|
511690|NCT00318409|O2|Outcome|Placebo|
511691|NCT00318409|O1|Outcome|Bupropion|
511692|NCT00318409|O2|Outcome|Placebo|
511693|NCT00318409|O1|Outcome|Bupropion|
511694|NCT00318409|O2|Outcome|Placebo|
511695|NCT00318409|O1|Outcome|Bupropion|
511696|NCT00318409|O1|Outcome|Persons Screened|
511697|NCT00318409|E2|Reported Event|Placebo|
511698|NCT00318409|E1|Reported Event|Bupropion|
511699|NCT00318370|B1|Baseline|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
511700|NCT00318370|P3|Participant Flow|Maintenance Far Only|Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed Period 2, Chemo Plus Far.
511701|NCT00318370|P2|Participant Flow|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
511702|NCT00318370|P1|Participant Flow|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
511703|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
511704|NCT00318370|O1|Outcome|Chemo Plus Far Plus Maintenance Far Only|"Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.~Maintenace Far Only: farletuzumab, 100 mg/m2"
511705|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
511706|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
511707|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
511708|NCT00318370|O1|Outcome|Chemo Plus Far|Platinum-based Chemotherapy plus farletuzumab (Chemo+Far): farletuzumab, 100 mg/m2 plus paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle.
511709|NCT00318370|O1|Outcome|Far Only|Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).
511710|NCT00318370|E1|Reported Event|Far Only and Chemo Plus Far and Maintenance Far Only|"Farletuzumab only (Far Only): farletuzumab, 100 milligrams (mg)/square meter (m2).~Chemo+Far: paclitaxel 175 mg/m2 (or docetaxel, 75 mg/m2) plus carboplatin area under the concentration-time curve (AUC) 5-6 intravenously (IV) on Day 1 of a 21-day cycle plus farletuzumab, 100 mg/m2.~Maintenance Far Only: farletuzumab, 100 milligrams (mg)/square meter (m2) for those subjects who completed the Period, Chemo Plus Far."
511711|NCT00318292|B3|Baseline|Total|Total of all reporting groups
511712|NCT00318292|B2|Baseline|Placebo|Placebo for preemptive local analgesia.
511713|NCT00318292|B1|Baseline|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
511714|NCT00318292|P2|Participant Flow|Placebo|Placebo for preemptive local analgesia.
511715|NCT00318292|P1|Participant Flow|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
511716|NCT00318292|O2|Outcome|Placebo|Placebo for preemptive local analgesia.
511717|NCT00318292|O1|Outcome|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
511718|NCT00318292|E2|Reported Event|Placebo|Placebo for preemptive local analgesia.
511719|NCT00318292|E1|Reported Event|Preemptive Local Analgesia (PLA)|Active preemptive local analgesia.
511720|NCT00318136|B1|Baseline|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511721|NCT00318136|P1|Participant Flow|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511876|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511722|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511723|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511724|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511725|NCT00318136|O1|Outcome|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511726|NCT00318136|E1|Reported Event|Treated With Bevacizumab|Chemotherapy (carboplatin + paclitaxel) in combination with bevacizumab in intervals of chemotherapy alone (Cycles 1 and 2), chemotherapy + bevacizumab (Cycles 3-6), and bevacizumab alone (Cycles 7 and beyond).
511727|NCT00317941|B3|Baseline|Total|Total of all reporting groups
511728|NCT00317941|B2|Baseline|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511729|NCT00317941|B1|Baseline|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511730|NCT00317941|P3|Participant Flow|Group C: IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511731|NCT00317941|P2|Participant Flow|Group B: IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
511732|NCT00317941|P1|Participant Flow|Group A: IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511733|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511734|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511735|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511736|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511737|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511738|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511739|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511740|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511741|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511742|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511743|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511744|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511745|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511746|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511747|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511748|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511749|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511750|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511751|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511752|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511753|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511754|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511755|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511756|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511757|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511758|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511759|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511760|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511761|NCT00317941|O3|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511762|NCT00317941|O2|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject Light|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject Light
511763|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron) Via Betaject|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject
511764|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511765|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511766|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511767|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511768|NCT00317941|O2|Outcome|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II
511769|NCT00317941|O1|Outcome|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light
511770|NCT00317941|E2|Reported Event|IFNB-1a 44 Mcg (Rebif) Via Rebiject II|Interferon beta-1a ([IFNB-1a] Rebif) 44 mcg (12 MIU) three times per week by subcutaneous injection using Rebiject II. Participants at risk from Group C in Participant flow.
511771|NCT00317941|E1|Reported Event|IFNB-1b 250 Mcg (Betaseron)|Interferon beta 1b ([IFNB-1b] Betaseron, BAY86-5046) 250 mcg (8 MIU) administered every other days by subcutaneous injection using Betaject or Betaject Light. Participants at risk from Group A and Group B in Participant flow.
511772|NCT00317720|B1|Baseline|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg given orally daily.
511773|NCT00317720|P2|Participant Flow|BIDMC/DFCI Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 5 or 10 mg by mouth daily.~Phase II: RAD001 10 mg/kg daily~ClinicalTrials.gov ID NCT00458237"
511774|NCT00317720|P1|Participant Flow|MDACC Trastuzumab + RAD001|"Phase I: Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 (Everolimus) 10 mg orally (PO) daily.~Phase II: RAD001 10 mg/kg daily + Trastuzumab 6 mg/kg maintenance dose~ClinicalTrials.gov ID: NCT00317720"
511775|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
511776|NCT00317720|O1|Outcome|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
511777|NCT00317720|E1|Reported Event|Trastuzumab + RAD001|Trastuzumab loading dose is 8 mg/kg daily; maintenance dose = 6 mg/kg once per 21 day cycle. RAD001 10 mg PO (by mouth) daily.
511778|NCT00317642|B3|Baseline|Total|Total of all reporting groups
511779|NCT00317642|B2|Baseline|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511780|NCT00317642|B1|Baseline|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511781|NCT00317642|P2|Participant Flow|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511782|NCT00317642|P1|Participant Flow|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511783|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511877|NCT00317044|O3|Outcome|Placebo|Placebo
516760|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
511784|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511785|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511786|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511787|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511788|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511789|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511790|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511791|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511792|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511793|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511794|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511795|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511796|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511797|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511798|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511878|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511799|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511800|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511801|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511802|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511803|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511804|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511805|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511806|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511807|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511808|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511809|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511810|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511811|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511812|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511813|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511879|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511880|NCT00317044|O3|Outcome|Placebo|Placebo
511977|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511814|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511815|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511816|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511817|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511818|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511819|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511820|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511821|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511822|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511823|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511824|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511825|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511826|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511827|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511828|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511881|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511829|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511830|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511831|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511832|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511833|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511834|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511835|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511836|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511837|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511838|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511839|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511840|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511841|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511842|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511843|NCT00317642|O2|Outcome|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511882|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511883|NCT00317044|O3|Outcome|Placebo|Placebo
511978|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511844|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511845|NCT00317642|O6|Outcome|Placebo and Cytarabine In Stratum >= 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511846|NCT00317642|O5|Outcome|Clofarabine and Cytarabine In Stratum >= 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511847|NCT00317642|O4|Outcome|Placebo and Cytarabine - In Stratum < 6 Months|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511848|NCT00317642|O3|Outcome|Clofarabine and Cytarabine - In Stratum < 6 Months|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511849|NCT00317642|O2|Outcome|Placebo and Cytarabine (FAS)|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511850|NCT00317642|O1|Outcome|Clofarabine (IV Formulation) and Cytarabine (FAS)|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511851|NCT00317642|E3|Reported Event|Overall|Combined total for the two Arms/Groups
511852|NCT00317642|E2|Reported Event|Placebo and Cytarabine|Participants received placebo (sodium chloride) administered as a 1-hour IV infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction, and consolidation.
511853|NCT00317642|E1|Reported Event|Clofarabine (IV Formulation) and Cytarabine|Participants received clofarabine 40 mg/m^2 administered as a 1-hour intravenous (IV) infusion, followed 3 hours later (from end of infusion) by cytarabine 1 g/m^2 administered as a 2-hour IV infusion for 5 days (induction and re-induction) or 4 days (consolidation). Participants could receive up to 3 cycles of treatment: induction, re-induction (if the participant had not achieved remission following induction but hematological improvement was noted), and consolidation.
511854|NCT00317239|B3|Baseline|Total|Total of all reporting groups
511855|NCT00317239|B2|Baseline|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
511856|NCT00317239|B1|Baseline|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
511857|NCT00317239|P2|Participant Flow|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
511858|NCT00317239|P1|Participant Flow|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
511859|NCT00317239|O2|Outcome|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
511860|NCT00317239|O1|Outcome|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
511861|NCT00317239|E2|Reported Event|Ferrous Sulfate Tablets|325 mg/TID x 8 weeks
511862|NCT00317239|E1|Reported Event|Ferric Carboxymaltose (FCM)|A maximum dose of 1,000 mg of FCM over 15 minutes on day 0, and a maximum dose of 500 mg of FCM over 15 minutes on days 17 and 31 based on Ferritin and TSAT values.
511863|NCT00317226|B1|Baseline|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
511864|NCT00317226|P1|Participant Flow|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
511865|NCT00317226|O1|Outcome|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
511866|NCT00317226|E1|Reported Event|Ferric Carboxymaltose (FCM)|maximum dose of 1,000 mg over 15 minutes IV administered within 7 days of the qualifying visit based on TSAT and Ferritin levels
511867|NCT00317044|B4|Baseline|Total|Total of all reporting groups
511868|NCT00317044|B3|Baseline|Placebo|Placebo
511869|NCT00317044|B2|Baseline|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511870|NCT00317044|B1|Baseline|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511871|NCT00317044|P3|Participant Flow|Placebo|Placebo
511872|NCT00317044|P2|Participant Flow|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511884|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511885|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511886|NCT00317044|O3|Outcome|Placebo|Placebo
511887|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511888|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511889|NCT00317044|O3|Outcome|Placebo|Placebo
511890|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511891|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511892|NCT00317044|O3|Outcome|Placebo|Placebo
511893|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511894|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511895|NCT00317044|O3|Outcome|Placebo|Placebo
511896|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511897|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511898|NCT00317044|O3|Outcome|Placebo|Placebo
511899|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511900|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511901|NCT00317044|O3|Outcome|Placebo|Placebo
511902|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511903|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511904|NCT00317044|O3|Outcome|Placebo|Placebo
511905|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511906|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511907|NCT00317044|O3|Outcome|Placebo|Placebo
511908|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511909|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511910|NCT00317044|O3|Outcome|Placebo|Placebo
511911|NCT00317044|O2|Outcome|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511912|NCT00317044|O1|Outcome|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511913|NCT00317044|E3|Reported Event|Placebo|Placebo
511914|NCT00317044|E2|Reported Event|Esomeprazole 40 mg Once Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules once daily
511915|NCT00317044|E1|Reported Event|Esomeprazole 40 mg Twice Daily|Nexium 40 mg given as esomeprazole magnesium trihydrate capsules twice daily
511916|NCT00316914|B3|Baseline|Total|Total of all reporting groups
511917|NCT00316914|B2|Baseline|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511918|NCT00316914|B1|Baseline|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511919|NCT00316914|P2|Participant Flow|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511920|NCT00316914|P1|Participant Flow|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511921|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511922|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511923|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511924|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511925|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511926|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511927|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511928|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511929|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511930|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511931|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511932|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511933|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511934|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511935|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511936|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511937|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511938|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511939|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511940|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511941|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511942|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511943|NCT00316914|O2|Outcome|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511944|NCT00316914|O1|Outcome|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511945|NCT00316914|E2|Reported Event|Placebo|Patients receive a placebo IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511946|NCT00316914|E1|Reported Event|Ca/Mg|Patients receive calcium gluconate (Ca) and magnesium sulfate (Mg) IV over 30 minutes immediately before and after each oxaliplatin administration (once every 2 weeks) of their assigned chemotherapy regimen.
511947|NCT00316888|B3|Baseline|Total|Total of all reporting groups
511948|NCT00316888|B2|Baseline|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511949|NCT00316888|B1|Baseline|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511950|NCT00316888|P2|Participant Flow|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511951|NCT00316888|P1|Participant Flow|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511952|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511970|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511971|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511972|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511973|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511974|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511953|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511954|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511955|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511956|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511957|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511958|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511959|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511960|NCT00316888|O2|Outcome|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511961|NCT00316888|O1|Outcome|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511962|NCT00316888|E2|Reported Event|Arm II (Open to Accrual on 8/18/2009)|"Patients receive cetuximab IV over 120 minutes on day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also receive cisplatin IV over 60 minutes on days 1 and 36, fluorouracil IV continuously over 96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5 weeks beginning on day 8. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511963|NCT00316888|E1|Reported Event|Arm I (Closed to Accrual as of 11/3/2008)|"Patients receive cisplatin IV over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120 minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57. Treatment continues in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~cisplatin: Given IV~fluorouracil: Given IV~radiation therapy: Given once daily 5 days a week for 5 weeks"
511964|NCT00316719|B3|Baseline|Total|Total of all reporting groups
511965|NCT00316719|B2|Baseline|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511966|NCT00316719|B1|Baseline|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511967|NCT00316719|P2|Participant Flow|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511968|NCT00316719|P1|Participant Flow|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511969|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
512079|NCT00316277|B3|Baseline|Total|Total of all reporting groups
511979|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511980|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511981|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511982|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511983|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511984|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511985|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511986|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511987|NCT00316719|O2|Outcome|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511988|NCT00316719|O1|Outcome|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511989|NCT00316719|E2|Reported Event|Lamivudine (LAM)|LAM 100 mg orally once daily for 52 weeks
511990|NCT00316719|E1|Reported Event|Adefovir (ADV)|ADV 10 mg orally once daily for 52 weeks
511991|NCT00316706|B3|Baseline|Total|Total of all reporting groups
511992|NCT00316706|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
511993|NCT00316706|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
511994|NCT00316706|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
511995|NCT00316706|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
511996|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
511997|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
511998|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
511999|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
512000|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
512001|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
512002|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
512003|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
512004|NCT00316706|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
512005|NCT00316706|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
512006|NCT00316706|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix™ (hepatitis A vaccine [HAV]) during the primary study (NCT00196924). Subjects from the this group completed the study at Month 24.
512007|NCT00316706|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals' HPV-16/18 Vaccine (Cervarix™) during the primary study (NCT00196924). Subjects from this group continued the long-term follow-up study until Month 48.
512008|NCT00316693|B3|Baseline|Total|Total of all reporting groups
512009|NCT00316693|B2|Baseline|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512010|NCT00316693|B1|Baseline|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512011|NCT00316693|P2|Participant Flow|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512012|NCT00316693|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512013|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512014|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512015|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512016|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512017|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512018|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512019|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512020|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512263|NCT00316017|B3|Baseline|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512021|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512022|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512023|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512024|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512025|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512026|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512027|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512028|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512029|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512030|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512031|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512032|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512033|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512034|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512035|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512036|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512037|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512038|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512039|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512040|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512041|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512042|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512043|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512044|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512045|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512046|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512047|NCT00316693|O2|Outcome|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512048|NCT00316693|O1|Outcome|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512049|NCT00316693|E2|Reported Event|Aimmugen Group|Subjects received 3 doses of Aimmugen™ (Hepatitis A [HAV] vaccine) according to a 0, 1, 6-month schedule.
512050|NCT00316693|E1|Reported Event|Cervarix Group|Subjects received 3 doses of GSK Biologicals HPV-16/18 vaccine (Cervarix™) according to a 0, 1, 6-month schedule.
512051|NCT00316355|B3|Baseline|Total|Total of all reporting groups
512052|NCT00316355|B2|Baseline|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
512053|NCT00316355|B1|Baseline|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Traditional CBT: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
512054|NCT00316355|P2|Participant Flow|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
512055|NCT00316355|P1|Participant Flow|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
512056|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
512140|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
516761|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
512057|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
512058|NCT00316355|O2|Outcome|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
512059|NCT00316355|O1|Outcome|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
512060|NCT00316355|E2|Reported Event|Stepped-Care CBT|"Stepped-care CBT~Stepped-Care CBT: In the CBT stepped-care program, patients are first provided with a less expensive, less intrusive, and more accessible option that resembles quality community care (e.g., self-administered EX/RP combined with counseling to address medication issues, life stress, and motivational enhancement). Patients who fail to respond to this initial treatment progress to a more intensive treatment (e.g., therapist-administered EX/RP)."
512061|NCT00316355|E1|Reported Event|Traditional CBT|"Cognitive-behavioral therapy (CBT) that incorporates exposure with ritual prevention (EX/RP)~Cognitive-Behavioral Therapy with EX/RP: CBT with EX/RP is a psychosocial treatment that incorporates exposure with ritual prevention."
512062|NCT00316303|B3|Baseline|Total|Total of all reporting groups
512063|NCT00316303|B2|Baseline|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
512064|NCT00316303|B1|Baseline|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512065|NCT00316303|P2|Participant Flow|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
512066|NCT00316303|P1|Participant Flow|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512067|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
512068|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512069|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
512070|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512071|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
512072|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512073|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A and hepatitis B immunizations, and any necessary treatments.
512074|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512075|NCT00316303|O2|Outcome|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, hepatitis A (HAV) and hepatitis B (HBV)immunizations, and any necessary treatments.
512076|NCT00316303|O1|Outcome|STIRR Intervention|The STIRR Intervention involves Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512077|NCT00316303|E2|Reported Event|Control Group|Participants will receive enhanced treatment as usual. This entails comprehensive mental health services provided at each study site, education about blood-borne diseases, and referral to a local community health provider for blood testing, HAV and HBV immunizations, and any necessary treatments.
512078|NCT00316303|E1|Reported Event|STIRR Intervention|The STIRR Intervention involved Screening for HIV and hepatitis C risk factors, Testing for HIV and hepatitis B and C infection, Immunization against hepatitis A and B, and Reducing risk and Referring for medical treatment for persons testing positive for HIV and hepatitis C.
512080|NCT00316277|B2|Baseline|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512081|NCT00316277|B1|Baseline|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512082|NCT00316277|P2|Participant Flow|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512083|NCT00316277|P1|Participant Flow|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512084|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512085|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512086|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Heroin Use|
512087|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Heroin Use|
512088|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Heroin Use|
512089|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Heroin Use|
512090|NCT00316277|O2|Outcome|Success in Phase 2 Among Participants Without Chronic Pain|
512091|NCT00316277|O1|Outcome|Success in Phase 2 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
512092|NCT00316277|O2|Outcome|Success in Phase 1 Among Participants Without Chronic Pain|
512093|NCT00316277|O1|Outcome|Success in Phase 1 Among Participants With Chronic Pain|"Patients were designated at baseline as having current chronic pain if they reported pain other than everyday kinds of pain excluding withdrawal-related pain, for at least 3 months."
512094|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512095|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512096|NCT00316277|O2|Outcome|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512097|NCT00316277|O1|Outcome|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512098|NCT00316277|E2|Reported Event|Buprenorphine/Nx With SMM|All study participants received buprenorphine-naloxone medication. This treatment group (buprenorphine-naloxone with Standard Medical Management) consisted of office visits with study physicians certified to prescribe buprenorphine.
512099|NCT00316277|E1|Reported Event|Buprenorphine/Nx With EMM|All study participants received buprenorphine-naloxone. This treatment group (Buprenorphine/Naloxone with Enhanced Medical Management) consisted of Standard Medical Management office visits with study physicians certified to prescribe buprenorphine and opioid drug counseling from a trained substance abuse or mental health professional.
512100|NCT00316264|B4|Baseline|Total|Total of all reporting groups
512101|NCT00316264|B3|Baseline|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512102|NCT00316264|B2|Baseline|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512103|NCT00316264|B1|Baseline|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512104|NCT00316264|P3|Participant Flow|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512105|NCT00316264|P2|Participant Flow|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512106|NCT00316264|P1|Participant Flow|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512107|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512108|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512264|NCT00316017|B2|Baseline|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512109|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512110|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512111|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512112|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512113|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512114|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512115|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512116|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512117|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512118|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512119|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512120|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512121|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512122|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512123|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512124|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512125|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512126|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512127|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512128|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512129|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512130|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512131|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512132|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512133|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512134|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512135|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512136|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512137|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512138|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512139|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512141|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512142|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512143|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512144|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512145|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512146|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512147|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512148|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512149|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512150|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512151|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512152|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512153|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512154|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512155|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512156|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512157|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512158|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512159|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512160|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512161|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512162|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512163|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512164|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512165|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512166|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512167|NCT00316264|O3|Outcome|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512168|NCT00316264|O2|Outcome|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512169|NCT00316264|O1|Outcome|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512170|NCT00316264|E3|Reported Event|Motavizumab (MEDI-524) Control|5 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512171|NCT00316264|E2|Reported Event|Palivizumab Followed by Motavizumab (MEDI-524)|2 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month)
512172|NCT00316264|E1|Reported Event|Motavizumab (MEDI-524) Followed by Palivizumab|2 doses of motavizumab (15 mg/kg, administered as an intramuscular injection once/month) followed by 3 doses of palivizumab (15 mg/kg, administered as an intramuscular injection once/month)
512173|NCT00316225|B1|Baseline|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512174|NCT00316225|P1|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512175|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512176|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512177|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512178|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512179|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512180|NCT00316225|O1|Outcome|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512181|NCT00316225|E1|Reported Event|Pemetrexed|Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
512182|NCT00316199|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512183|NCT00316199|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512184|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512185|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512186|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512187|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512188|NCT00316199|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512189|NCT00316199|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression.~Paclitaxel: 175 mg/m2, intravenous (IV), every 21 days until disease progression"
512190|NCT00316186|B1|Baseline|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512191|NCT00316186|P1|Participant Flow|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512192|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512193|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512194|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512195|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512196|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512197|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512198|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512199|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512200|NCT00316186|O1|Outcome|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512201|NCT00316186|E1|Reported Event|Intravenous Topotecan and Carboplatin|Administered Weekly (Days 1 and 8 for topotecan; Day 1 for carboplatin) every 21 days
512202|NCT00316173|B3|Baseline|Total|Total of all reporting groups
512203|NCT00316173|B2|Baseline|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512204|NCT00316173|B1|Baseline|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
512205|NCT00316173|P2|Participant Flow|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512206|NCT00316173|P1|Participant Flow|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
512207|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512208|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512209|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512210|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512211|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512212|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512213|NCT00316173|O1|Outcome|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512214|NCT00316173|E2|Reported Event|Activity Assessment Phase|Topotecan 2.5 mg/m2 (starting dose determined from the dose-finding phase) administered as a 30 minute intravenous (IV) infusion on Days 1 and 8, every 21 days. Carboplatin AUC 5 administered as a 30 minute IV infusion on Day 1, every 21 days.
512215|NCT00316173|E1|Reported Event|Dose-finding Phase|Starting dose of 2.0 milligrams (mg)/square meter (m2) topotecan (Days 1 and 8, every 21 days) and area under the curve (AUC) 5 carboplatin (Day 1 every 21 days)
512216|NCT00316121|B3|Baseline|Total|Total of all reporting groups
512217|NCT00316121|B2|Baseline|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
512218|NCT00316121|B1|Baseline|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
512219|NCT00316121|P2|Participant Flow|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
512220|NCT00316121|P1|Participant Flow|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
512221|NCT00316121|O2|Outcome|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
512222|NCT00316121|O1|Outcome|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
512223|NCT00316121|E2|Reported Event|Control|Autograft is bone taken from the subject’s own hip and placed in and around the spinal implant and spinal instrumentation. Local bone (bone from the area of surgery and placed in the fusion site) may be used in combination with autograft.
512224|NCT00316121|E1|Reported Event|HEALOS|"HEALOS is a synthetic bone graft material made of collagen (a fibrous protein) and hydroxyapatite (a natural mineral structure). The collagen is a bovine derivative (obtained from cows). HEALOS is similar to what is found in natural bone and has the clearance of the U.S. Food and Drug Administration for use in filling bony voids or gaps of the skeletal system. It is combined with bone marrow (a vascular or vessel-like tissue found in the cavity of bone) to form new bone. HEALOS with bone marrow aspirate is currently available for use in a procedure where rods and screws are placed in the back with graft material to fuse the vertebrae.~The Leopard cage is a spinal implant made of a material called carbon fiber. HEALOS, when used with the Leopard Cage is an investigational device. An investigational device is one that is being tested and has not yet received approval from the Food and Drug Administration for the use in which it is being tested."
512225|NCT00316082|B6|Baseline|Total|Total of all reporting groups
512226|NCT00316082|B5|Baseline|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512227|NCT00316082|B4|Baseline|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512261|NCT00316082|E1|Reported Event|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512228|NCT00316082|B3|Baseline|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512229|NCT00316082|B2|Baseline|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512230|NCT00316082|B1|Baseline|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512231|NCT00316082|P5|Participant Flow|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512232|NCT00316082|P4|Participant Flow|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512233|NCT00316082|P3|Participant Flow|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512234|NCT00316082|P2|Participant Flow|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512235|NCT00316082|P1|Participant Flow|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512236|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512237|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512238|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512239|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512240|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512241|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512242|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512243|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512244|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512245|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512246|NCT00316082|O5|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512247|NCT00316082|O4|Outcome|Saxagliptin 5 mg Once in the Evening (QPM)|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512248|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512249|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512250|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg Once in the Morning (QAM)|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512251|NCT00316082|O2|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512252|NCT00316082|O1|Outcome|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512253|NCT00316082|O4|Outcome|Placebo|The Placebo group includes data from subjects randomized to receive administration of placebo oral tablets daily.
512254|NCT00316082|O3|Outcome|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512255|NCT00316082|O2|Outcome|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512256|NCT00316082|O1|Outcome|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512257|NCT00316082|E5|Reported Event|Saxagliptin 5 mg QPM|The Saxagliptin 5 mg QPM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QPM daily.
512258|NCT00316082|E4|Reported Event|Saxagliptin 5 mg QAM|The Saxagliptin 5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 5 mg oral tablets QAM daily.
512259|NCT00316082|E3|Reported Event|Saxagliptin 2.5 mg QAM|The Saxagliptin 2.5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily.
512260|NCT00316082|E2|Reported Event|Saxagliptin 2.5/5 mg QAM|The Saxagliptin 2.5/5 mg QAM group includes data from subjects randomized to receive administration of blinded Saxagliptin 2.5 mg oral tablets QAM daily, with possible titration to 5 mg oral tablets QAM.
512262|NCT00316017|B4|Baseline|Total|Total of all reporting groups
512265|NCT00316017|B1|Baseline|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512266|NCT00316017|P3|Participant Flow|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512267|NCT00316017|P2|Participant Flow|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512268|NCT00316017|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512269|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512270|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512271|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512272|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512273|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512274|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512275|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512276|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512277|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512278|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512279|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512280|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512281|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512282|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512283|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512284|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512285|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512286|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512287|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512288|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512289|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512290|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512291|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512292|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512293|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512294|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512295|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512296|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512297|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512298|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512299|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512300|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512301|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512302|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512303|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512304|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512305|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512306|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512307|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512308|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512309|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512310|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512311|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512312|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512313|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512314|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512315|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512316|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512317|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512318|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512319|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512320|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512321|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512322|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512323|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512324|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512325|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512326|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512327|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512328|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512329|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512330|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512331|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512332|NCT00316017|O3|Outcome|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512333|NCT00316017|O2|Outcome|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512334|NCT00316017|O1|Outcome|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512335|NCT00316017|E3|Reported Event|0.9% Normal Saline|0.9% normal saline 250 ml dose as placebo
512336|NCT00316017|E2|Reported Event|7.5% Hypertonic Saline (HS)|7.5% hypertonic saline (HS) 250ml dose
512337|NCT00316017|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran-70 (HSD)|7.5% hypertonic saline/6% Dextran-70 (HSD) 250 ml
512338|NCT00316004|B4|Baseline|Total|Total of all reporting groups
512339|NCT00316004|B3|Baseline|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512340|NCT00316004|B2|Baseline|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512341|NCT00316004|B1|Baseline|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512342|NCT00316004|P3|Participant Flow|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512343|NCT00316004|P2|Participant Flow|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512344|NCT00316004|P1|Participant Flow|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512345|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512346|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512347|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512348|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512349|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512350|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512351|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512352|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512353|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512354|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512355|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512356|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512357|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512358|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512359|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512360|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512763|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512361|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512362|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512363|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512364|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512365|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512366|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512367|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512368|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512369|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512370|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512371|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512372|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512373|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512374|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512375|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512376|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512377|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512378|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512379|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512380|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512381|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512382|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512383|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512384|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512385|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512386|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512387|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512525|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512388|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512389|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512390|NCT00316004|O3|Outcome|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512391|NCT00316004|O2|Outcome|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512392|NCT00316004|O1|Outcome|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512393|NCT00316004|E3|Reported Event|0.9% Normal Saline (NS)|250 ml intravenous bolus administration of 0.9% saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512394|NCT00316004|E2|Reported Event|7.5% Hypertonic Saline (HS)|250 ml intravenous bolus administration of 7.5% hypertonic saline as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512395|NCT00316004|E1|Reported Event|7.5% Hypertonic Saline/6% Dextran (HSD)|250 ml intravenous bolus administration of 7.5% saline/6% dextran 70 as the initial resuscitation fluid given to injured patients with suspected severe traumatic brain injury in the out-of-hospital setting.
512396|NCT00315939|B3|Baseline|Total|Total of all reporting groups
512397|NCT00315939|B2|Baseline|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Group B will begin with level 2, followed by level 3 and then level 1. Each level will continue for 3 months.
512398|NCT00315939|B1|Baseline|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Group A will perform routine SMBG alone (level 1), followed sequentially by levels 2 and 3. Each level continued for 3 months.
512399|NCT00315939|P2|Participant Flow|Experimental: Group B Order: IBMF-1, IBMF-2, SMBG|Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 followed by IBMF-2, level 3 and then SMBG only. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
512400|NCT00315939|P1|Participant Flow|Experimental: Group A Order: SMBG, IBMF-1, IBMF-2|Self-monitored blood glucose (SMBG) alone (level 1), followed sequentially by Integrated Biobehavioral Monitoring & Feedback - 1 (IBMF-1) level 2 and IBMF-2, level 3. IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry. IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
512401|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
512402|NCT00315939|O1|Outcome|Experimental Groups A and B|"Group A: SMBG alone (level 1), followed sequentially by levels 2 and 3. Group B: Level 2, followed by level 3 and then level 1.~Each level continued for 3 months.~IBMF-1 (level 2) retained level 1, but an HHC (hand-held computer) was given to the subjects, programmed to estimate HbA1c, risk for hypoglycemia, and glucose variability. The subjects were asked to carry the HHC and enter all their glucose readings when performing SMBG. The estimates of HbA1c were updated weekly, and the estimates of risk for hypoglycemia and glucose variability were updated at each SMBG entry.~IBMF-2 (level 3) retained level 2, but the HHC asked subjects to provide symptom ratings when BG (blood glucose) was low and at an equal number of matching euglycemic readings. From these data, the HHC estimated a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure."
512403|NCT00315939|E2|Reported Event|IBMF-2|IBMF-2 retains level 2, but the HHC asks subjects to provide symptom ratings when BG (blood glucose) is low and at an equal number of matching euglycemic readings. From these data, the HHC estimates a set of potentially significant symptoms of hypoglycemia for each individual, using an iterative algorithm following a previously published symptom significance estimation procedure.
512438|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512526|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512404|NCT00315939|E1|Reported Event|IBMF-1|IBMF-1 will use the OneTouch® UltraSmart® glucometer (LifeScan, Milpitas, CA) to collect routine SMBG data and the subject transfers the blood glucose (BG) value into a hand-held computer (HHC) for processing. As the subject checks BG on a daily basis, the IBMF-1 software calculates an estimate of HbA1c, acute risk for hypoglycemia and chronic risk for hypoglycemia. This information will be presented back to the subject. Specifically, (i) alarms for immediate action if BG<50 mg/dL is registered; (ii) a running HbA1c estimate (71); (iii) a warning to be more careful and measure BG more frequently over the next 24 hours if elevated acute risk for hypoglycemia is found, and (iv) an indication of the subject's chronic risk for hypoglycemia in one of 4 categories (minimal, low, moderate, and high). At moderate and high risk the subject will be prompted to consider altering his/her behavior. HbA1c and chronic risk change slowly (2-3 weeks), while acute risk can change daily.
512405|NCT00315731|B1|Baseline|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512406|NCT00315731|P1|Participant Flow|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512407|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512408|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512409|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512410|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512411|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512412|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512422|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512413|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512414|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512415|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512416|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512417|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512418|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512419|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512420|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512421|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab Dosimetric dose (administered on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512437|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512522|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512423|NCT00315731|O2|Outcome|Tellurium-Derived Iodine I-131 Tositumomab|Evaluable participant data from the historical trial, Study RIT II 003 (NCT01224821), in which participants received tisitumomab and tellurium-derived iodine I-131 tositumomab dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512424|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512425|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512426|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512427|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512428|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512429|NCT00315731|O1|Outcome|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512430|NCT00315731|E1|Reported Event|Tositumomab and Fission-derived Iodine I-131 Tositumomab|Dosimetric dose (administered only once on Day 0): 450 milligrams (mg) unlabeled tositumomab administered intravenously (IV) for 1 hour, followed immediately by 5 millicurie (mCi) fission-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. Therapeutic dose (administered only once on Day 7): 450 mg unlabeled tositumomab administered IV for 1 hour, followed immediately by Tellurium-derived iodine I-131 tositumomab (contained in 35 mg tositumomab) administered IV for 20 minutes. The dose was calculated based on the dosimetric dose results to deliver a total body radiation dose of 75 centigray (cGy).
512431|NCT00315705|B3|Baseline|Total|Total of all reporting groups
512432|NCT00315705|B2|Baseline|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512433|NCT00315705|B1|Baseline|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512434|NCT00315705|P1|Participant Flow|Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2. > Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512435|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512436|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
512764|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512439|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
512440|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512441|NCT00315705|O1|Outcome|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously
512442|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512443|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512444|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512445|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512446|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512447|NCT00315705|O1|Outcome|Phase 1: Clofarabine, Etoposide, Cyclophosphamide|Phase 1: escalating dosage of the three drugs delivered intravenously. Clofarabine dosage from 20-40 mg/m^2, etoposide dosage from 75-100 mg/m^2, cyclophosphamide dosage from 340-440 mg/m^2.
512448|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512449|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512450|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512451|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
512452|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
512453|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512454|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512455|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512456|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
512457|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
512458|NCT00315705|O5|Outcome|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512459|NCT00315705|O4|Outcome|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512460|NCT00315705|O3|Outcome|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512461|NCT00315705|O2|Outcome|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
512462|NCT00315705|O1|Outcome|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
512463|NCT00315705|E7|Reported Event|Phase 2: Clofarabine, Etoposide, Cyclophosphamide|Phase 2: The recommended phase 2 doses (RP2D) were clofarabine 40 mg/m^2, etoposide 100 mg/m^2 and cyclophosphamide 440 mg/m^2 delivered intravenously.
512464|NCT00315705|E6|Reported Event|Phase 1 - Total|All participants from Cohorts 1-5 in Phase 1
512465|NCT00315705|E5|Reported Event|Phase 1 - Cohort 5|Participants were treated with clofarabine 40 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512466|NCT00315705|E4|Reported Event|Phase 1 - Cohort 4|Participants were treated with clofarabine 30 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512467|NCT00315705|E3|Reported Event|Phase 1 - Cohort 3|Participants were treated with clofarabine 20 mg/m^2, etoposide 100 mg/m^2, and cyclophosphamide 440 mg/m^2.
512468|NCT00315705|E2|Reported Event|Phase 1 - Cohort 2|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 440 mg/m^2.
512469|NCT00315705|E1|Reported Event|Phase 1 - Cohort 1|Participants were treated with clofarabine 20 mg/m^2, etoposide 75 mg/m^2, and cyclophosphamide 340 mg/m^2.
512470|NCT00315614|B1|Baseline|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
512471|NCT00315614|P1|Participant Flow|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
512472|NCT00315614|O1|Outcome|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
512473|NCT00315614|E1|Reported Event|Islet Transplantation and CD34 Bone Marrow|Islet Transplantation: Islet transplantation
512474|NCT00315458|B3|Baseline|Total|Total of all reporting groups
512475|NCT00315458|B2|Baseline|Double-blind BTDS|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
512476|NCT00315458|B1|Baseline|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
512523|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512524|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512477|NCT00315458|P4|Participant Flow|Extension Phase BTDS 5/10/20|Subjects who finished the entire 12-week (84-day) double-blind phase were eligible to participate in the open-label extension phase. Subjects began treatment with BTDS 5 and their doses were titrated to BTDS 10 or BTDS 20 as needed.
512478|NCT00315458|P3|Participant Flow|Run-in Period BTDS 5/10/20|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
512479|NCT00315458|P2|Participant Flow|Double-blind BTDS 10/20|Test treatments buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
512480|NCT00315458|P1|Participant Flow|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
512481|NCT00315458|O4|Outcome|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
512482|NCT00315458|O3|Outcome|Run-in Period|All subjects were started on BTDS 5 and titrated to BTDS 10 and 20. Subjects who met the protocol-specified criteria for adequate analgesia were eligible for entry into the double-blind phase. Subjects who could not tolerate at least BTDS 10 were discontinued from the study.
512483|NCT00315458|O2|Outcome|Double-blind BTDS|Test treatment buprenoprhine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
512484|NCT00315458|O1|Outcome|Double-blind Placebo|Reference treatment placebo 10 or 20 applied for 7-day wear
512485|NCT00315458|E4|Reported Event|Overall BTDS Exposure|Total number of subjects exposed to BTDS for overall study which includes the core study and extension phase.
512486|NCT00315458|E3|Reported Event|Run-in Period|Open-label Run-in period (BTDS 5, 10, or 20) applied for 7-day wear
512487|NCT00315458|E2|Reported Event|Double-blind BTDS 10/20|Test treatment buprenorphine transdermal patch (BTDS) 10 or BTDS 20 applied for 7-day wear
512488|NCT00315458|E1|Reported Event|Double-blind Placebo Patch|Reference Treatment placebo 10 or 20 applied for 7-day wear
512489|NCT00315445|B4|Baseline|Total|Total of all reporting groups
512490|NCT00315445|B3|Baseline|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512491|NCT00315445|B2|Baseline|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512492|NCT00315445|B1|Baseline|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512493|NCT00315445|P3|Participant Flow|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512494|NCT00315445|P2|Participant Flow|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512495|NCT00315445|P1|Participant Flow|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512496|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512497|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512498|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512499|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512500|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512501|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512502|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512503|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512504|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512505|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512506|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512507|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512508|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512509|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512510|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512511|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512512|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512513|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512514|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512515|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512516|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512517|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512518|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512519|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512520|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512521|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512527|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512528|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512529|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512530|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512531|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512532|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512533|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512534|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512535|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512536|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512537|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512538|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512539|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512540|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512541|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512542|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512543|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512544|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512545|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512546|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512547|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512548|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512549|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512550|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512551|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512552|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512553|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512554|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512555|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512556|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512557|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512558|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512559|NCT00315445|O3|Outcome|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512560|NCT00315445|O2|Outcome|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512561|NCT00315445|O1|Outcome|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512562|NCT00315445|E3|Reported Event|BTDS|Buprenorphine transdermal patch 5, 10, or 20 mcg/hour applied for 7-day wear.
512563|NCT00315445|E2|Reported Event|OXY/APAP|5 mg oxycodone/325 mg acetaminophen, 1, 2, or 3 tablets four times/day.
512564|NCT00315445|E1|Reported Event|Placebo|Placebo oxycodone/acetaminophen (APAP) 1, 2, or 3 tablets four times/day and transdermal patch (TDS) placebo 5, 10, or 20 applied for 7-day wear.
512565|NCT00315341|B3|Baseline|Total|Total of all reporting groups
512566|NCT00315341|B2|Baseline|Methadone|
512567|NCT00315341|B1|Baseline|Buprenorphine/Nx|
512568|NCT00315341|P2|Participant Flow|Methadone|The mean dose of methadone was 93.2 mg.
512569|NCT00315341|P1|Participant Flow|Buprenorphine/Nx|Participants received medication for 24 weeks in the active phase of the study. The mean dose of buprenorphine was 22.3 mg. Blood samples for measurement of liver function were taken at baseline and at Weeks 1, 2, 4 8, 12, 16, 20, and 24 with follow-up at Week 32.
512570|NCT00315341|O2|Outcome|Methadone|
512571|NCT00315341|O1|Outcome|Buprenorphine/Nx|
512572|NCT00315341|E2|Reported Event|Methadone|For the MET group, all participants will receive a maximum of 30 mg for the first dose and a maximum of 40 mg on Day 1. It is recommended that participants receive a dose on day 2 that is 10 mg higher than their total day 1 dose, and a dose on day 3 that is 10 mg higher than their total day 2 dose, unless, in the clinical judgment of the physician, a slower induction is needed. Doses will be adjusted on Day 4 and thereafter according to clinical impression and depending upon the participant’s clinical need with no specific upper limit. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
512606|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
516762|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
512573|NCT00315341|E1|Reported Event|Buprenorphine/Nx|For the BUP/NX group, all participants will receive up to 16 mg BUP/4 mg NX on day 1 and up to 32 mg BUP/8 mg NX on day 2. It is recommended that dose changes be made in 2 to 8 mg buprenorphine increments, with the range of allowable daily doses between 2 mg and 32 mg starting on day 3 and thereafter according to clinical impression and depending upon the participant’s clinical need. Investigators are encouraged to dose adequately to decrease craving and to obtain negative urine toxicology specimens.
512574|NCT00315328|B5|Baseline|Total|Total of all reporting groups
512575|NCT00315328|B4|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512576|NCT00315328|B3|Baseline|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512577|NCT00315328|B2|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512578|NCT00315328|B1|Baseline|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512579|NCT00315328|P4|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512580|NCT00315328|P3|Participant Flow|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512581|NCT00315328|P2|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512582|NCT00315328|P1|Participant Flow|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512583|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512584|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512585|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512586|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512587|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512588|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512589|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512590|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512591|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512592|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512593|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512594|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512595|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512596|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512597|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512598|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512599|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512600|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512601|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512602|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512603|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512604|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512605|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512748|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512607|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512608|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512609|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512610|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512611|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512612|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512613|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512614|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512615|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512616|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512617|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512618|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512619|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512620|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512621|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512622|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512623|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512624|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512625|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512626|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512627|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512628|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512629|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512630|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512631|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512632|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512633|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512634|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512635|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512636|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512637|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512638|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512639|NCT00315328|O4|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512640|NCT00315328|O3|Outcome|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512749|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512641|NCT00315328|O2|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512642|NCT00315328|O1|Outcome|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512643|NCT00315328|E4|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with severe amblyopia (20/125 to 20/400).
512644|NCT00315328|E3|Reported Event|Patching-Severe Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with severe amblyopia (20/125 to 20/400)
512645|NCT00315328|E2|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus near activities for at least one hour every day among patients with moderate amblyopia (20/40 to 20/100).
512646|NCT00315328|E1|Reported Event|Patching-Moderate Amblyopia|Patching 2 hours per day plus near activities for one hour while patching among patients with moderate amblyopia (20/40 to 20/100)
512647|NCT00315302|B5|Baseline|Total|Total of all reporting groups
512648|NCT00315302|B4|Baseline|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512649|NCT00315302|B3|Baseline|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512650|NCT00315302|B2|Baseline|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512651|NCT00315302|B1|Baseline|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512652|NCT00315302|P4|Participant Flow|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512653|NCT00315302|P3|Participant Flow|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512654|NCT00315302|P2|Participant Flow|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512655|NCT00315302|P1|Participant Flow|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512656|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512657|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512658|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512659|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512660|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512661|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512662|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512663|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512664|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512665|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512666|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512667|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512668|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512669|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512670|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512671|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512672|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512673|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512674|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512675|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512676|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512677|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512750|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512678|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512679|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512680|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512681|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512682|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512683|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512684|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512685|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512686|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512687|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512688|NCT00315302|O4|Outcome|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512689|NCT00315302|O3|Outcome|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512690|NCT00315302|O2|Outcome|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512691|NCT00315302|O1|Outcome|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512692|NCT00315302|E4|Reported Event|Atropine Plus Plano-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with severe amblyopia (20/125 to 20/400)
512693|NCT00315302|E3|Reported Event|Atropine-Severe Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with severe (20/125 to 20/400)
512694|NCT00315302|E2|Reported Event|Atropine Plus Plano-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye plus a plano lens for the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512695|NCT00315302|E1|Reported Event|Atropine-Moderate Amblyopia|Atropine 1% once each weekend day in the sound eye among patients with moderate amblyopia (20/40 to 20/100)
512696|NCT00315146|B5|Baseline|Total|Total of all reporting groups
512697|NCT00315146|B4|Baseline|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
512698|NCT00315146|B3|Baseline|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
512699|NCT00315146|B2|Baseline|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
512700|NCT00315146|B1|Baseline|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
512751|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512752|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512701|NCT00315146|P4|Participant Flow|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
512702|NCT00315146|P3|Participant Flow|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
512703|NCT00315146|P2|Participant Flow|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
512704|NCT00315146|P1|Participant Flow|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
512705|NCT00315146|O4|Outcome|Hypocaloric Diet,Resistance Training, Pioglitazone/Actos™|"Pioglitazone~Resistance exercise training to maximize muscle power~Hypocaloric diet"
512706|NCT00315146|O3|Outcome|Hypocaloric Diet and a PPAR- γ Agonist (Pioglitazone/Actos™)|"Pioglitazone~Hypocaloric diet"
512707|NCT00315146|O2|Outcome|Hypocaloric Diet, Resist. Training to Maximize Power, Placebo|"Resistance exercise training to maximize muscle power~Hypocaloric diet~Placebo"
512708|NCT00315146|O1|Outcome|Hypocaloric Diet (and Placebo)|"Hypocaloric diet~Placebo"
512709|NCT00315146|O4|Outcome|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
512710|NCT00315146|O3|Outcome|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
512711|NCT00315146|O2|Outcome|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
512753|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512754|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512755|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512712|NCT00315146|O1|Outcome|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
512713|NCT00315146|E4|Reported Event|Hypocaloric Weight Loss + Resistance Training + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone."
512714|NCT00315146|E3|Reported Event|Hypocaloric Weight-loss +Resistance Training|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~The goal of the resistance training program was to increase strength and muscle mass in the major muscle groups of the body, while also improving muscle power in the lower extremity. Participants randomized to the resistance training exercised 3 days/week. Participants warmed-up by walking or cycling for 3-5 min at a slow pace followed by 5 min of large muscle flexibility exercises targeting the major muscle groups of the body. Training sessions ended with a cool-down session of light stretching."
512715|NCT00315146|E2|Reported Event|Hypocaloric Weight Loss + Pioglitazone|"Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day.~Pioglitazone was given an initial 15 mg/day dose. Participants were assessed for side effects after 3 weeks, but none were reported. Therefore, after 3 weeks, the dose was increased to 30 mg/day for the remainder of the study for all participants randomized to receive pioglitazone. In order to understand the potential effects of changes in body composition independent of drug effects, a 1-week wash-out period preceded the follow-up outcome assessment."
512716|NCT00315146|E1|Reported Event|Hypocaloric Weight Loss Only|Two meal replacements per day (bars and shakes) were provided to all participants (containing ~220 kcal with 7-10 g protein, 33-46 g carbohydrates, and 1.5-5 g fat with 2-5 g of fiber). For the third meal, a weekly menu plan with recipes was given to the participants. This meal was composed of traditional foods, was low in fat, high in vegetables but allowed for individual preferences, and provided 500-750 kcal. In addition, up to three snacks (~100 kcal each) were allowed each day. The macronutrient goal for each individual was ~55-60% carbohydrates, ~15% protein, and ~25% fat.
512717|NCT00315120|B5|Baseline|Total|Total of all reporting groups
512718|NCT00315120|B4|Baseline|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
512719|NCT00315120|B3|Baseline|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
512720|NCT00315120|B2|Baseline|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
512721|NCT00315120|B1|Baseline|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
512722|NCT00315120|P4|Participant Flow|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound physical therapy
512723|NCT00315120|P3|Participant Flow|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound physical therapy
512724|NCT00315120|P2|Participant Flow|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound physical therapy
512725|NCT00315120|P1|Participant Flow|OMT + UST|Active osteopathic manipulation and active ultrasound physical therapy
512726|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512727|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512728|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512729|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512730|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512731|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512732|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512733|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512734|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512735|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512736|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512737|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512738|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512739|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512740|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512741|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512742|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512743|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512744|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512745|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512746|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512747|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512765|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512766|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound therapy
512767|NCT00315120|O1|Outcome|Active UST|Active ultrasound therapy
512768|NCT00315120|O2|Outcome|Sham UST|Sham ultrasound physical therapy
512769|NCT00315120|O1|Outcome|Active UST|Active ultrasound physical therapy
512770|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512771|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512772|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512773|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512774|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512775|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512776|NCT00315120|O2|Outcome|Sham OMT|Sham osteopathic manipulation
512777|NCT00315120|O1|Outcome|Active OMT|Active osteopathic manipulation
512778|NCT00315120|E4|Reported Event|Sham OMT + Sham UST|Sham osteopathic manipulation and sham ultrasound therapy
512779|NCT00315120|E3|Reported Event|OMT + Sham UST|Active osteopathic manipulation and sham ultrasound therapy
512780|NCT00315120|E2|Reported Event|Sham OMT + UST|Sham osteopathic manipulation and active ultrasound therapy
512781|NCT00315120|E1|Reported Event|OMT + UST|Active osteopathic manipulation and active ultrasound therapy
512782|NCT00315055|B3|Baseline|Total|Total of all reporting groups
512783|NCT00315055|B2|Baseline|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512784|NCT00315055|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512785|NCT00315055|P2|Participant Flow|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512786|NCT00315055|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512787|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512788|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512789|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512790|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512791|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP IPV PRP T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX®) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512792|NCT00315055|O1|Outcome|DTaP-IPV-HB-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP IPV Hep B PRP T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512793|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512794|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512795|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512796|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512797|NCT00315055|O2|Outcome|PENTAXIM™ and ENGERIX® PEDIATRIC|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512798|NCT00315055|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
516763|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
512799|NCT00315055|E2|Reported Event|PENTAXIM™ and ENGERIX®|Participants received 3 vaccinations with DTaP-IPV-PRP~T (PENTAXIM™ ) and recombinant Hepatitis B (ENGERIX® PEDIATRIC) vaccines, with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512800|NCT00315055|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received 3 vaccinations with Diphtheria (D) and tetanus (T) toxoids, acellular pertussis (2-component) (aP), recombinant Hepatitis B surface antigen (HBsAg), inactivated poliomyelitis virus (IPV), and Hemophilus influenzae type b (Hib) polysaccharide conjugated to tetanus protein (DTaP-IPV-Hep B-PRP~T), with one dose each at 2, 3, and 4 months of age (Days 0, 30, and 60).
512801|NCT00314951|B3|Baseline|Total|Total of all reporting groups
512802|NCT00314951|B2|Baseline|Fidaxomicin|200 mg administered twice daily (q12hr)
512803|NCT00314951|B1|Baseline|Vancomycin|125 mg administered 4 times daily (q6hr)
512804|NCT00314951|P2|Participant Flow|Fidaxomicin|200 mg administered twice daily (q12hr)
512805|NCT00314951|P1|Participant Flow|Vancomycin|125 mg administered 4 times daily (q6hr)
512806|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
512807|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
512808|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
512809|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
512810|NCT00314951|O2|Outcome|Fidaxomicin|200 mg administered twice daily (q12hr)
512811|NCT00314951|O1|Outcome|Vancomycin|125 mg administered 4 times daily (q6hr)
512812|NCT00314951|E2|Reported Event|Fidaxomicin|200 mg administered twice daily (q12hr)
512813|NCT00314951|E1|Reported Event|Vancomycin|125 mg administered 4 times daily (q6hr)
512814|NCT00314808|B1|Baseline|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512815|NCT00314808|P1|Participant Flow|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512816|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512817|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512818|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512819|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512820|NCT00314808|O1|Outcome|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512821|NCT00314808|E1|Reported Event|Dronabinol|Dronabinol 5 mg BID administered 24 hours prior to, during, and 48 hours after completion of oral/intravenous chemotherapy for a maximum of 2 consecutive cycles
512822|NCT00314574|B3|Baseline|Total|Total of all reporting groups
512823|NCT00314574|B2|Baseline|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512824|NCT00314574|B1|Baseline|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512825|NCT00314574|P2|Participant Flow|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512826|NCT00314574|P1|Participant Flow|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512827|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512828|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512877|NCT00314366|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
513151|NCT00313443|B1|Baseline|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
512829|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512830|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512831|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512832|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512833|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512834|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512835|NCT00314574|O2|Outcome|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512836|NCT00314574|O1|Outcome|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512837|NCT00314574|E2|Reported Event|Xolair|"Omalizumab (Xolair) subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512838|NCT00314574|E1|Reported Event|Placebo|"Placebo subcutaneous dose minimum of 0.008 mg/kg/IgE (IU/mL) every 2 weeks or a minimum of 0.016 mg/kg/IgE (IU/mL) every 4 weeks for 48 weeks.~Participants maintained their high-dose inhaled corticosteroid (minimum of 500 µg of fluticasone dry powder inhaler twice a day or its ex-valve equivalent) and Long-Acting Beta-Agonist dose (either 50 µg salmeterol twice daily or 12 µg formoterol twice daily) throughout the study.~Participants were permitted to use albuterol as rescue medicine throughout the study."
512839|NCT00314106|B3|Baseline|Total|Total of all reporting groups
512840|NCT00314106|B2|Baseline|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
512841|NCT00314106|B1|Baseline|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
512842|NCT00314106|P2|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
512843|NCT00314106|P1|Participant Flow|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
512844|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
512845|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
512846|NCT00314106|O2|Outcome|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
512847|NCT00314106|O1|Outcome|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
512848|NCT00314106|E2|Reported Event|TBI 1200 cGy + TIL +HD IL-2, no Prior IL-2|Patients that have not received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses)
512849|NCT00314106|E1|Reported Event|TBI 1200 cGy + TIL +HD IL-2, Prior IL-2|Patients that received prior interleukin 2 (IL-2) therapy will receive a myeloablative lymphocyte depleting preparative regimen consisting of cyclophosphamide (60 mg/kg/day x 2 days intravenous (IV)), fludarabine (25mg/m^2/day IV X 5 days) and 1200 cGy total body irradiation (TBI). Following the lymphodepleting regimen, patient will receive intravenous adoptive transfer of tumor reactive lymphocytes (minimum 3 X 10 (9) and up to a maximum of 3 X 10(11) lymphocytes) followed by high-dose intravenous (IV) IL-2 (720,000 IU/kg/dose every 8 hours for up to 15 doses).
512850|NCT00314366|B3|Baseline|Total|Total of all reporting groups
512851|NCT00314366|B2|Baseline|Control|"Control (Placebo) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512852|NCT00314366|B1|Baseline|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512853|NCT00314366|P2|Participant Flow|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512854|NCT00314366|P1|Participant Flow|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512855|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512856|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512857|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512943|NCT00314145|P2|Participant Flow|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
512858|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512859|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512860|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512861|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512862|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512863|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512864|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512865|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512866|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512867|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512868|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512869|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512870|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512871|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512872|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512873|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512874|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512875|NCT00314366|O2|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512876|NCT00314366|O1|Outcome|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
516764|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
512878|NCT00314366|O1|Outcome|Control|"Placebo patients will receive injections of plasma (control) instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~At 6 months, subject is offered stem cell therapy and then followed for 12 months.~Control (plasma): Placebo patients receive an injection of plasma (control) containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512879|NCT00314366|E2|Reported Event|Control|"Placebo (control) patients will receive injections of plasma control instead of stem cells. Placebo patients are able to crossover and receive active treatment at 6 months if they meet the criteria.~Plasma control: Placebo patients receive an injection of plasma containing 5 % albumin the the same quantity as the stem cell arm. A total of 15 injections of 0.2 ml to total 3.0 ml."
512880|NCT00314366|E1|Reported Event|Stem Cell Therapy|"Subjects are randomized to receive Stem Cell Therapy (treatment) at the time of enrollment where cells are delivered after NOGA mapping and cells injected with the Myostar catheter.~Stem Cell Therapy: Cells are injected under electromechanical guidance and delivered by the Myostar catheter after NOGA mapping."
512881|NCT00314353|B3|Baseline|Total|Total of all reporting groups
512882|NCT00314353|B2|Baseline|Capecitabine, Irinotecan, Bevacizumab|
512883|NCT00314353|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab|
512884|NCT00314353|P2|Participant Flow|Capecitabine, Irinotecan, Bevacizumab|
512885|NCT00314353|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab|
512886|NCT00314353|O2|Outcome|Capecitabine, Irinotecan, Bevacizumab|
512887|NCT00314353|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab|
512888|NCT00314353|E2|Reported Event|Capecitabine, Irinotecan, Bevacizumab|
512889|NCT00314353|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab|
512890|NCT00314340|B1|Baseline|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
512891|NCT00314340|P1|Participant Flow|All Participants|All participants were randomized to receive the ER morphine tablets, 45 mg, hydrocodone 30 mg plus N-acetyl-para-aminophenol 975 mg, or placebo in a 3 way cross over design.
512892|NCT00314340|O3|Outcome|Placebo|
512893|NCT00314340|O2|Outcome|Hydrocodone 30 mg Plus N-acetyl-para-aminophenol 975 mg|These findings all argue against the hypothesis that the hydrocodone product induced a greater euphoric or reinforcing effect than that of ER morphine.
512894|NCT00314340|O1|Outcome|ER Morphine Tablets, 45mg|Scores of the 5 Addiction Research Center Inventory dimensions did not change significantly between baseline and 300 min under any treatment condition.
512895|NCT00314340|E1|Reported Event|Prescription Opioid Abusers|The subjective effects of the study drug were evaluated with the short form of the Addiction Research Center Inventory (ARCI. This inventory consists of 49 true/ false questions which survey major domains of drug effects. Participants indicated the pleasurable effects or desirability of the medications on 4 locally developed drug-liking ratings: craving, liking, strong desire, and “want more pain medication.” Ratings were made on a 100-mm VAS anchored with 0 at the low end and 10 at the high end. Participants also responded to 11 locally developed drug-effect ratings to assess psychoactive effects. Ratings were again made on a 100-mmVAS anchoredwith 0 at the lowend and 10 at the high end for:“on cloud 9,” “high,” “good drug effect,” “bad drug effect,” “impaired,”“stoned,” “sedated,” “confused,” “nauseated from,” “anxious,” and “down”. The rating levels over a six hour period were examined to explore the timing of these effects.
512896|NCT00314327|B1|Baseline|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
512897|NCT00314327|P1|Participant Flow|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
512898|NCT00314327|O1|Outcome|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
512944|NCT00314145|P1|Participant Flow|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512899|NCT00314327|E1|Reported Event|Long-acting Injectable Risperidone|"One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection.~long-acting injectable risperidone: One week of oral risperidone dosage started at 2mg for the first day and then increased to 4mg. If no side effects are noted, participants are started on the long-acting risperidone. The usual dosage of long-acting risperidone in the study will be 25mg every 2 weeks for a total of 12 weeks. The medication will be administered intramuscularly via injection."
512900|NCT00314262|B1|Baseline|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512901|NCT00314262|P1|Participant Flow|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512902|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512903|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512904|NCT00314262|O1|Outcome|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512905|NCT00314262|E1|Reported Event|Erlotinib & Celecoxib|"Erlotinib & Celecoxib: Erlotinib given orally, once daily (dose escalation from 50 mg, 75 mg, or 100 mg) continuously for 6 months in the phase I portion.~Celecoxib given 400 mg orally BID continuously for 6 months."
512906|NCT00314249|B3|Baseline|Total|Total of all reporting groups
512907|NCT00314249|B2|Baseline|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512908|NCT00314249|B1|Baseline|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512909|NCT00314249|P2|Participant Flow|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512910|NCT00314249|P1|Participant Flow|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512911|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512912|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512913|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512914|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512915|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512916|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512917|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512918|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512919|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512920|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512921|NCT00314249|O2|Outcome|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512922|NCT00314249|O1|Outcome|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512923|NCT00314249|E2|Reported Event|Milnacipran|Milnacipran 100 mg per day, administered orally (BID [twice a day]) for 12 weeks of stable dose treatment phase
512924|NCT00314249|E1|Reported Event|Placebo|Placebo administered orally BID (twice a day) for 12 weeks of stable dose treatment phase
512925|NCT00314236|B3|Baseline|Total|Total of all reporting groups
512926|NCT00314236|B2|Baseline|Control|Microfracture alone
512927|NCT00314236|B1|Baseline|Experimental|BST-CarGel applied to a Microfractured lesion
512928|NCT00314236|P2|Participant Flow|Control|Microfracture alone
512929|NCT00314236|P1|Participant Flow|Experimental|BST-CarGel applied to a Microfractured lesion
512930|NCT00314236|O2|Outcome|Control|Microfracture alone
512931|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
512932|NCT00314236|O2|Outcome|Control|Microfracture alone
512933|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
512934|NCT00314236|O2|Outcome|Control|Microfracture alone
512935|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
512936|NCT00314236|O2|Outcome|Control|Microfracture alone
512937|NCT00314236|O1|Outcome|Experimental|BST-CarGel applied to a Microfractured lesion
512938|NCT00314236|E2|Reported Event|Control|Microfracture alone
512939|NCT00314236|E1|Reported Event|Experimental|BST-CarGel applied to a Microfractured lesion
512940|NCT00314145|B3|Baseline|Total|Total of all reporting groups
512941|NCT00314145|B2|Baseline|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
512942|NCT00314145|B1|Baseline|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
513123|NCT00313703|E2|Reported Event|Tension-type Headache|met International Headache Society tension-type headache criteria
512945|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
512946|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512947|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
512948|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512949|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
512950|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512951|NCT00314145|O2|Outcome|ChimeriVax™-JE|All participants received 1 subcutaneous dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 PFU and saline placebo into different arms.
512952|NCT00314145|O1|Outcome|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512953|NCT00314145|E2|Reported Event|ChimeriVax™-JE|All participants received 1 dose each of saline placebo on Days 0 and 7. On Day 30, participants received vaccinations of ChimeriVax™-JE vaccine 4 log10 Plaque-forming unit (PFU) and saline placebo into different arms.
512954|NCT00314145|E1|Reported Event|JE-VAX®|All participants received 1 subcutaneous dose each of JE-VAX® vaccine on Days 0, 7, and 30, and a subcutaneous dose of saline placebo into a different arm on Day 30.
512955|NCT00314132|B3|Baseline|Total|Total of all reporting groups
512956|NCT00314132|B2|Baseline|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
512957|NCT00314132|B1|Baseline|Placebo|Participants received a single injection of placebo on Day 0.
512958|NCT00314132|P2|Participant Flow|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 Plaque-forming unit (PFU) Vaccine on Day 0.
512959|NCT00314132|P1|Participant Flow|Placebo|Participants received a single injection of placebo on Day 0.
512960|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
512961|NCT00314132|O1|Outcome|Placebo|Participants received a single injection of placebo on Day 0.
512962|NCT00314132|O2|Outcome|ChimeriVax™-JE 4 log10 PFU Vaccine|All participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
512963|NCT00314132|O1|Outcome|Placebo|All subjects received a single injection of placebo on Day 0.
512964|NCT00314132|E2|Reported Event|ChimeriVax™-JE 4 log10 PFU Vaccine|Participants received a single injection of ChimeriVax™-JE 4 log10 PFU Vaccine on Day 0.
512965|NCT00314132|E1|Reported Event|Placebo|Participants received a single injection of placebo on Day 0.
512966|NCT00313911|B3|Baseline|Total|Total of all reporting groups
512967|NCT00313911|B2|Baseline|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512968|NCT00313911|B1|Baseline|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512969|NCT00313911|P2|Participant Flow|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512970|NCT00313911|P1|Participant Flow|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512971|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512972|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512973|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512974|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512975|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512976|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
513124|NCT00313703|E1|Reported Event|Migraine|met International Headache Society migraine criteria
512977|NCT00313911|O2|Outcome|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512978|NCT00313911|O1|Outcome|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512979|NCT00313911|E2|Reported Event|Tritanrix-Hep B/Hib™ + OPV|Participants received Tritanrix-Hep B/Hib™ + oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512980|NCT00313911|E1|Reported Event|DTaP-IPV-Hep B-PRP~T|Participants received Diphtheria (D), tetanus (T), pertussis (acellular, component) (aP), hepatitis B (hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-Hep B-PRP~T) plus a Placebo, oral poliovirus vaccine (OPV) in a 3-dose series with single doses at 2, 4, and 6 months of age.
512981|NCT00313846|B3|Baseline|Total|Total of all reporting groups
512982|NCT00313846|B2|Baseline|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
512983|NCT00313846|B1|Baseline|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
512984|NCT00313846|P2|Participant Flow|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
512985|NCT00313846|P1|Participant Flow|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
512986|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
512987|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
512988|NCT00313846|O2|Outcome|Double-blind BTDS|Test treatment in the double-blind phase. Buprenorphine transdermal patches 5, 10, or 20 applied for 7-day wear.
512989|NCT00313846|O1|Outcome|Double-blind Placebo|Reference treatment in the double-blind phase. Placebo transdermal patches matched the BTDS patches applied for 7-day wear.
512990|NCT00313846|E3|Reported Event|Open-label Run-in Period BTDS 5, 10, or 20|Open-label Run-in Period (less than or equal to 21 days): All subjects began treatment on BTDS 5 and titrated to a maximum of BTDS 20 to achieve effective pain control. Subjects were treated for a minimum of 3 days with any given dose of BTDS before up-titration to the next strength patch was considered. One down-titration was permitted. Subjects meeting protocol-defined criteria for adequate analgesia within 21 days were eligible for entry into the double-blind phase.
512991|NCT00313846|E2|Reported Event|Double-blind BTDS 5, 10, or 20|Test treatments in the double-blind phase
512992|NCT00313846|E1|Reported Event|Double-blind Placebo Patch 5, 10, or 20|Reference treatment in the double-blind phase
512993|NCT00313820|B3|Baseline|Total|Total of all reporting groups
512994|NCT00313820|B2|Baseline|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
512995|NCT00313820|B1|Baseline|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
512996|NCT00313820|P2|Participant Flow|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
512997|NCT00313820|P1|Participant Flow|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
512998|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
512999|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513000|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513001|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513002|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513003|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513004|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513005|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513006|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513007|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513008|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513009|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513010|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513011|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513012|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513013|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513014|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513015|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513016|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513017|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513018|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513019|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513020|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513021|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513022|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513023|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513024|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513025|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513026|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513027|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513028|NCT00313820|O2|Outcome|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513029|NCT00313820|O1|Outcome|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513030|NCT00313820|E2|Reported Event|Placebo|75 milligram (mg) capsule PO BID for 7 days. Placebo was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513031|NCT00313820|E1|Reported Event|Pregabalin|75 milligram (mg) capsule by mouth (PO) twice a day (BID) for 7 days. Pregabalin was titrated over the first 4 weeks based on tolerability and pain scores. Range was 150 mg total daily dose to a maximum of 600 mg total daily dose. Week 1: 150 mg BID for 7 days; Weeks 2 through 4: maintained at previous dose level or dose increased or reduced based on tolerability and pain scores (150 mg or 300 mg or 600 mg total daily dose). After the fourth week, dose was maintained until week 12 when dose was tapered to 75 mg BID.
513032|NCT00313781|B3|Baseline|Total|Total of all reporting groups
513033|NCT00313781|B2|Baseline|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513034|NCT00313781|B1|Baseline|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513035|NCT00313781|P3|Participant Flow|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513036|NCT00313781|P2|Participant Flow|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513037|NCT00313781|P1|Participant Flow|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion intravenously (IV) over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21 days cycle, up to 17 cycles.
513038|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513039|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513040|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513041|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513042|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513043|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513044|NCT00313781|O2|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513045|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513046|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513047|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513048|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513049|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513125|NCT00313612|B3|Baseline|Total|Total of all reporting groups
516765|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
513050|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513051|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513052|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513053|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513054|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513055|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513056|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513057|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513058|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513059|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513060|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513061|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513062|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513063|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513064|NCT00313781|O3|Outcome|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513065|NCT00313781|O2|Outcome|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513066|NCT00313781|O1|Outcome|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513067|NCT00313781|E3|Reported Event|Docetaxel+Prednisone+CP-751,871 Crossover|Participants from the “Docetaxel+Prednisone” group who, after disease progression while receiving docetaxel and prednisone alone, opted to receive CP-751,871 20 mg/kg infusion IV on Day 1 of a 21 days cycle, along with docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 and prednisone 5 mg BID, up to 17 cycles.
513068|NCT00313781|E2|Reported Event|Docetaxel+Prednisone|Participants received docetaxel 75 mg/m^2 infusion IV over 1 hour on Day 1 along with prednisone 5 mg BID in a 21 days cycle, up to 17 cycles.
513069|NCT00313781|E1|Reported Event|CP-751,871+Docetaxel+Prednisone|Participants received docetaxel 75 milligram(mg)/square meter(m^2) infusion IV over 1 hour on Day 1, followed by CP-751,871 20 mg/kilogram (kg) infusion IV on Day 1 along with prednisone 5 mg twice daily (BID) in a 21-days cycle, up to 17 cycles.
513070|NCT00313716|B7|Baseline|Total|Total of all reporting groups
513071|NCT00313716|B6|Baseline|Placebo/TT10 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 10 g/dl
513072|NCT00313716|B5|Baseline|Epo2/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 10 g/dl
513073|NCT00313716|B4|Baseline|Epo1/TT10 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 10 g/dl
513074|NCT00313716|B3|Baseline|Placebo/TT7 Arm|Patients received saline and transfused to keep hemoglobin concentration at least 7 g/dl
513075|NCT00313716|B2|Baseline|Epo2/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin concentration at least 7 g/dl
513076|NCT00313716|B1|Baseline|Epo1/TT7 Arm|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury and transfused to keep hemoglobin at least 7 g/dl
513077|NCT00313716|P6|Participant Flow|Placebo/TT10 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 10 gm/dl
513150|NCT00313586|E1|Reported Event|Arm A (Azacitidine)|Patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513078|NCT00313716|P5|Participant Flow|Epo2/TT10 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
513079|NCT00313716|P4|Participant Flow|Epo1/TT10 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 10 gm/dl
513080|NCT00313716|P3|Participant Flow|Placebo/TT7 Arm|Placebo (patients received saline) and hemoglobin transfusion threshold 7 gm/dl
513081|NCT00313716|P2|Participant Flow|Epo2/TT7 Arm|Low dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
513082|NCT00313716|P1|Participant Flow|Epo1/TT7 Arm|High dose Epo (patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury) and hemoglobin transfusion threshold 7 gm/dl
513083|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 group, Epo2/TT10 group, and Placebo/TT10 group combined)
513084|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513085|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
513086|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513087|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
513088|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513089|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
513090|NCT00313716|O2|Outcome|Epo2 Group|Patients received 500 IU/kg within 6 hrs after injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
513091|NCT00313716|O1|Outcome|Epo1 Group|Patients received 500 IU/kg erythropoietin within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
513092|NCT00313716|O2|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
513093|NCT00313716|O1|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513094|NCT00313716|O5|Outcome|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
513095|NCT00313716|O4|Outcome|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513096|NCT00313716|O3|Outcome|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
513097|NCT00313716|O2|Outcome|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, and at 9 and 16 days after injury (Epo2/TT10 arm and Epo2/TT7 arm combined)
513098|NCT00313716|O1|Outcome|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
513099|NCT00313716|E5|Reported Event|TT10 Group|Patients had hemoglobin concentration maintained at least 10 gm/dl (Epo1/TT10 arm, Epo2/TT10 arm, and Placebo/TT10 arm combined)
513100|NCT00313716|E4|Reported Event|TT7 Group|Patients had hemoglobin concentration maintained at least 7 gm/dl (Epo1/TT7 arm, Epo2/TT7 arm, and Placebo/TT7 arm combined)
513101|NCT00313716|E3|Reported Event|Placebo Group|Patients received saline (Placebo/TT10 arm and Placebo/TT7 arm combined)
513102|NCT00313716|E2|Reported Event|Epo2 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
513103|NCT00313716|E1|Reported Event|Epo1 Group|Patients received erythropoietin 500 IU/kg within 6 hrs of injury, at 24 and 48 hrs after injury, and at 9 and 16 days after injury (Epo1/TT10 arm and Epo1/TT7 arm combined)
513104|NCT00313703|B5|Baseline|Total|Total of all reporting groups
513105|NCT00313703|B4|Baseline|Other|Met other International Headache Society criteria
513106|NCT00313703|B3|Baseline|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
513107|NCT00313703|B2|Baseline|Tension-type Headache|met International Headache Society tension-type headache criteria
513108|NCT00313703|B1|Baseline|Migraine|met International Headache Society migraine criteria
513109|NCT00313703|P4|Participant Flow|Other|Met other International Headache Society criteria
513110|NCT00313703|P3|Participant Flow|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
513111|NCT00313703|P2|Participant Flow|Tension-type Headache|met International Headache Society tension-type headache criteria
513112|NCT00313703|P1|Participant Flow|Migraine|met International Headache Society migraine criteria
513113|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
513114|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
513115|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
513116|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
513117|NCT00313703|O4|Outcome|Other|Met other International Headache Society criteria
513118|NCT00313703|O3|Outcome|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
513119|NCT00313703|O2|Outcome|Tension-type Headache|met International Headache Society tension-type headache criteria
513120|NCT00313703|O1|Outcome|Migraine|met International Headache Society migraine criteria
513121|NCT00313703|E4|Reported Event|Other|Met other International Headache Society criteria
513122|NCT00313703|E3|Reported Event|Unclassifiable|Had recurrent headache disorder but did not meet any International Headache Society criteria
513126|NCT00313612|B2|Baseline|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513127|NCT00313612|B1|Baseline|Treatment Stratum I: (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513128|NCT00313612|P2|Participant Flow|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Treatment stratum II (oxaliplatin plus topotecan) is sensitive to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513129|NCT00313612|P1|Participant Flow|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Treatment stratum I (oxaliplatin plus topotecan) is resistant to prior platinum therapy. Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513130|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513131|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513132|NCT00313612|O2|Outcome|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513133|NCT00313612|O1|Outcome|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513134|NCT00313612|E2|Reported Event|Treatment Stratum II (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513135|NCT00313612|E1|Reported Event|Treatment Stratum I (Oxaliplatin Plus Topotecan)|"Patients receive oxaliplatin IV over 2 hours on days 1 and 15 and topotecan IV continuously on days 1-14. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed at 30 days.~oxaliplatin: Given IV~topotecan: Given IV"
513136|NCT00313586|B5|Baseline|Total|Total of all reporting groups
513137|NCT00313586|B4|Baseline|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513138|NCT00313586|B3|Baseline|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513139|NCT00313586|B2|Baseline|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513140|NCT00313586|B1|Baseline|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513141|NCT00313586|P4|Participant Flow|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513142|NCT00313586|P3|Participant Flow|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513143|NCT00313586|P2|Participant Flow|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513144|NCT00313586|P1|Participant Flow|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513145|NCT00313586|O4|Outcome|Arm B (Azacitidine + Entinostat; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513146|NCT00313586|O3|Outcome|Arm A (Azacitidine; Treatment-induced Cohort)|Treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513147|NCT00313586|O2|Outcome|Arm B (Azacitidine + Entinostat; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513148|NCT00313586|O1|Outcome|Arm A (Azacitidine; Non-treatment-induced Cohort)|Non-treatment-induced patients receive azacitidine (50 mg/m2) subcutaneously once daily on days 1-10 in a 28-day cycle.
513149|NCT00313586|E2|Reported Event|Arm B (Azacitidine + Entinostat)|Patients receive azacitidine as in arm A and oral entinostat (4 mg/m2) on days 3 and 10 of each 28-day cycle.
513152|NCT00313443|P1|Participant Flow|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513153|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513154|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513155|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513156|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513157|NCT00313443|O1|Outcome|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513158|NCT00313443|E1|Reported Event|Amiodarone/Fat Tissue Needle Aspiration|Unique arm: all patients underwent amiodarone dosage in blood and fat tissue samplings
513159|NCT00313313|B4|Baseline|Total|Total of all reporting groups
513160|NCT00313313|B3|Baseline|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513161|NCT00313313|B2|Baseline|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513162|NCT00313313|B1|Baseline|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513163|NCT00313313|P3|Participant Flow|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513164|NCT00313313|P2|Participant Flow|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513165|NCT00313313|P1|Participant Flow|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513166|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513167|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513168|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513169|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513170|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513171|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513172|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513219|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513276|NCT00313170|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513173|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513174|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513175|NCT00313313|O3|Outcome|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513176|NCT00313313|O2|Outcome|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513177|NCT00313313|O1|Outcome|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513178|NCT00313313|E3|Reported Event|Saxagliptin 5 mg + Glyburide 7.5 mg|The Saxagliptin 5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513179|NCT00313313|E2|Reported Event|Saxagliptin 2.5 mg + Glyburide 7.5 mg|The Saxagliptin 2.5 mg + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded saxagliptin 2.5 mg oral tablets and open-label glyburide 7.5 mg oral tables once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator.
513180|NCT00313313|E1|Reported Event|Placebo + Glyburide 7.5 mg|The Placebo + Glyburide 7.5 mg group includes data from subjects randomized to receive coadministration of blinded placebo oral tablets, blinded glyburide 2.5 mg, and open-label glyburide 7.5 mg once daily. Open-label glyburide may have been down titrated by 2.5 mg once due to hypoglycemia as deemed necessary by the investigator. Blinded glyburide may have been uptitrated by 5 mg according to glycemic criteria provided it had not been previously down-titrated.
513181|NCT00313300|B6|Baseline|Total|Total of all reporting groups
513182|NCT00313300|B5|Baseline|Apixaban 20 mg QD|"Tablet of apixaban, oral, for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated."
513183|NCT00313300|B4|Baseline|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, this treatment group was terminated"
513184|NCT00313300|B3|Baseline|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513185|NCT00313300|B2|Baseline|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513186|NCT00313300|B1|Baseline|Placebo|Tablet of Placebo for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513187|NCT00313300|P5|Participant Flow|Apixaban 20 mg QD|"Phase B of the Study: Tablet of Apixaban 20 mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the apixaban 20 mg QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
513188|NCT00313300|P4|Participant Flow|Apixaban 10mg BID|"Phase B of the Study: Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B, the DSMB recommended that the 10 mg BID QD group, be terminated due to excess bleeding for participants receiving aspirin and clopidogrel concomitantly with the 10 mg BID apixaban. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants)."
513189|NCT00313300|P3|Participant Flow|Apixaban 10mg QD|In both Phase A and Phase B of the study: Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
513190|NCT00313300|P2|Participant Flow|Apixaban 2.5mg BID|In both Phase A and Phase B of the study: Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
513220|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513221|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513222|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513223|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513191|NCT00313300|P1|Participant Flow|Placebo|Study was conducted in 2 Phases (A and B). A tablet of Placebo along with ≤ 165 mg of aspirin was given daily for 26 weeks. 75 mg of clopidogrel once a day (QD) was allowed at the investigator’s discretion. After 547 subjects were randomized to Phase A, an independent Data and Safety Monitoring Board (DSMB) recommended expanding the randomization to 2 higher doses of apixaban (10 mg BID and 20 mg QD) in Phase B of the study. Approximately 6 months after the start of Phase B, the DSMB recommended apixaban high dose groups be terminated due to excess bleeding in those participants receiving aspirin and clopidogrel concomitantly with high dose apixaban. Treatment and any new randomization into these 2 groups was halted, while randomization and treatment in the placebo and lower dose apixaban groups continued. Follow-up Period started after Week 26 through 30 days after discontinuation of study drug (for treated participants).
513192|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513193|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513194|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513195|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513196|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513197|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513198|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513199|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513200|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513201|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513202|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513203|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513204|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513205|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513206|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513207|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513208|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513209|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513210|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513211|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo, oral, for 26 weeks. Also ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513212|NCT00313300|O5|Outcome|Apixaban 20 mg QD|"Tablet of apixaban QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513213|NCT00313300|O4|Outcome|Apixaban 10mg BID|"Tablet of Apixaban 10mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.~Approximately 6 months after the start of Phase B this treatment group was terminated."
513214|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513215|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513216|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513217|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513218|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513273|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513224|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513225|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, ≤165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513226|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513227|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513228|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513229|NCT00313300|O3|Outcome|Apixaban 10mg QD|Tablet of Apixaban 10mg QD for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513230|NCT00313300|O2|Outcome|Apixaban 2.5mg BID|Tablet of Apixaban 2.5mg BID for 26 weeks. Also, ≤ 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513231|NCT00313300|O1|Outcome|Placebo|Tablet of Placebo daily for 26 weeks. Also, less than, equal to (≤) 165 mg of aspirin daily. 75 mg of clopidogrel QD was allowed at the investigator’s discretion.
513232|NCT00313300|E8|Reported Event|Phase B Placebo|Participants treated with at least one dose of Placebo during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
513233|NCT00313300|E7|Reported Event|Phase B Apixaban 2.5mg BID|Participants treated with at least one dose of 2.5 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
513234|NCT00313300|E6|Reported Event|Phase B Apixaban 20mg QD|Participants treated with at least one dose of 20 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
513235|NCT00313300|E5|Reported Event|Phase B Apixaban 10mg QD|Participants treated with at least one dose of 10 mg QD apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
513236|NCT00313300|E4|Reported Event|Phase B Apixaban 10mg BID|Participants treated with at least one dose of 10 mg BID apixaban during Phase B as measured from the start of randomization in Phase B and up to termination of high dose apixaban (October 2007)
513237|NCT00313300|E3|Reported Event|Phase A+B Placebo|Total Phase A and Phase B participants combined who received at least 1 dose of placebo during the study.
513238|NCT00313300|E2|Reported Event|Phase A+B Apixaban 2.5mg BID|Total Phase A and Phase B participants combined who received at least 1 dose of 2.5 mg BID apixaban during the study.
513239|NCT00313300|E1|Reported Event|Phase A+B Apixaban 10mg QD|Total Phase A and Phase B participants combined who received at least 1 dose of 10 mg QD apixaban during the study.
513240|NCT00313209|B3|Baseline|Total|Total of all reporting groups
513241|NCT00313209|B2|Baseline|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513242|NCT00313209|B1|Baseline|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513243|NCT00313209|P2|Participant Flow|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513244|NCT00313209|P1|Participant Flow|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513245|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513246|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513247|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513248|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513249|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513250|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513251|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513252|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513253|NCT00313209|O2|Outcome|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513254|NCT00313209|O1|Outcome|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513255|NCT00313209|E2|Reported Event|Placebo|Placebo, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513256|NCT00313209|E1|Reported Event|Roflumilast|Roflumilast 500 µg, once daily, oral and salmeterol 50 µg, twice daily, inhaled
513257|NCT00313170|B4|Baseline|Total|Total of all reporting groups
513258|NCT00313170|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
513259|NCT00313170|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513260|NCT00313170|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
513261|NCT00313170|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
513262|NCT00313170|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513263|NCT00313170|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
513264|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
513265|NCT00313170|O1|Outcome|Fulvestrant|Fulvestrant arms pooled
513266|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
513267|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513268|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
513269|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
513270|NCT00313170|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
513271|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
513272|NCT00313170|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
513274|NCT00313170|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
513279|NCT00313144|P1|Participant Flow|Overall Study|Participants were treated with ARALAST according to dose and frequency of infusions recommended by their physician.
513280|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513281|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513282|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513283|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513284|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513285|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513286|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513287|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513288|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513289|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513290|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513291|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513292|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513293|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513294|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513295|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513296|NCT00313144|O1|Outcome|Year Prior to Baseline|
513297|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513298|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513299|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513300|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513301|NCT00313144|O1|Outcome|Year Prior to Baseline|
513302|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513303|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513304|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513305|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513306|NCT00313144|O1|Outcome|Year Prior to Baseline|
513307|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513308|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513309|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513310|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513311|NCT00313144|O1|Outcome|Year Prior to Baseline|
513312|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513313|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513314|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513315|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513316|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513317|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513318|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513319|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513320|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513321|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513322|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513323|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513324|NCT00313144|O1|Outcome|Year Prior to Baseline|
513325|NCT00313144|O4|Outcome|>18 Months to ≤24 Months|
513326|NCT00313144|O3|Outcome|>12 Months to ≤18 Months|
513327|NCT00313144|O2|Outcome|>6 Months to ≤12 Months|
513328|NCT00313144|O1|Outcome|Baseline to ≤6 Months|
513329|NCT00313144|O5|Outcome|>18 Months to ≤24 Months|
513330|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513331|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513332|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513333|NCT00313144|O1|Outcome|Baseline|
513334|NCT00313144|O4|Outcome|>12 Months to ≤18 Months|
513335|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513336|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513337|NCT00313144|O1|Outcome|Baseline|
513338|NCT00313144|O3|Outcome|>6 Months to ≤12 Months|
513339|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513340|NCT00313144|O1|Outcome|Baseline|
513341|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513342|NCT00313144|O1|Outcome|Baseline|
513343|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513344|NCT00313144|O1|Outcome|Baseline|
513345|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513346|NCT00313144|O1|Outcome|Baseline|
513347|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513348|NCT00313144|O1|Outcome|Baseline|
513349|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513350|NCT00313144|O1|Outcome|Baseline|
513351|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513352|NCT00313144|O1|Outcome|Baseline|
513353|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513354|NCT00313144|O1|Outcome|Baseline|
513355|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513356|NCT00313144|O1|Outcome|Baseline|
513357|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513358|NCT00313144|O1|Outcome|Baseline|
513359|NCT00313144|O2|Outcome|Baseline to ≤6 Months|
513360|NCT00313144|O1|Outcome|Baseline|
513361|NCT00313144|E1|Reported Event|Overall Study|
513362|NCT00313014|B4|Baseline|Total|Total of all reporting groups
513363|NCT00313014|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513364|NCT00313014|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513365|NCT00313014|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513366|NCT00313014|P3|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513367|NCT00313014|P2|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513368|NCT00313014|P1|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513369|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513370|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513371|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513372|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513373|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513374|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513375|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513376|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513377|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513378|NCT00313014|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone HCl immediate-release 40 mg (two 5-mg capsules every 6 hours).
513379|NCT00313014|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513380|NCT00313014|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513381|NCT00313014|E4|Reported Event|Open-label Run-in Period, BTDS 10/20|Open-label BTDS 10 or 20 mcg/h applied for 7-day wear
513382|NCT00313014|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513383|NCT00313014|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513384|NCT00313014|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513385|NCT00312923|B3|Baseline|Total|Total of all reporting groups
513386|NCT00312923|B2|Baseline|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
513387|NCT00312923|B1|Baseline|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
513388|NCT00312923|P2|Participant Flow|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
513389|NCT00312923|P1|Participant Flow|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
513390|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
513391|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
513392|NCT00312923|O2|Outcome|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
513393|NCT00312923|O1|Outcome|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
513394|NCT00312923|E2|Reported Event|Control Group|Placebo : Two capsules of 10 mg of microcrystalline cellulose daily
513395|NCT00312923|E1|Reported Event|Treatment Group|"20 mg daily of policosanol~Policosanol : 20 mg of policosanol in capsular form daily"
513396|NCT00312884|B3|Baseline|Total|Total of all reporting groups
513397|NCT00312884|B2|Baseline|Intervention Arm|Received daily home monitoring
513398|NCT00312884|B1|Baseline|Usual Care|Recieved usual follow-up care
513399|NCT00312884|P2|Participant Flow|Usual Care|Received usual hospital care with no Telemonitoring
513400|NCT00312884|P1|Participant Flow|Intervention Arm|Recieved home telemonitoring daily HomMed Telemonitoring System: The HomeMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
513401|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513402|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513403|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513404|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513405|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513406|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513407|NCT00312884|O2|Outcome|Intervention Arm|"Recieved telemonitoring~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513408|NCT00312884|O1|Outcome|Usual Care|"Recieved usual hospital and community care~HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home"
513409|NCT00312884|E2|Reported Event|Intervention Arm|Recieved telemonitoring daily via the HomMed Telemonitoring System: The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
513410|NCT00312884|E1|Reported Event|Usual Care|Recieved usual hospital care
513411|NCT00312858|B3|Baseline|Total|Total of all reporting groups
513412|NCT00312858|B2|Baseline|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513517|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513413|NCT00312858|B1|Baseline|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513414|NCT00312858|P2|Participant Flow|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513415|NCT00312858|P1|Participant Flow|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513416|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513417|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513418|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513419|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513420|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513421|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513422|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513423|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513424|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513425|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513426|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513427|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513428|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513429|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513430|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513431|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513432|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513518|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513433|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513434|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513435|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513436|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513437|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513438|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513439|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513440|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513441|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513442|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513443|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513444|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513445|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513446|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513447|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513448|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513449|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513450|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513451|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513452|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513519|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513453|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513454|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513455|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513456|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513457|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513458|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513459|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513460|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513461|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513462|NCT00312858|O2|Outcome|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513463|NCT00312858|O1|Outcome|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513464|NCT00312858|E2|Reported Event|Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™|VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
513465|NCT00312858|E1|Reported Event|Arm 1: VAQTA™ + ProQuad™ + Prevnar™|VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
513466|NCT00312845|B3|Baseline|Total|Total of all reporting groups
513467|NCT00312845|B2|Baseline|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
513468|NCT00312845|B1|Baseline|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
513469|NCT00312845|P2|Participant Flow|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
513470|NCT00312845|P1|Participant Flow|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
513471|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
513472|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
513473|NCT00312845|O2|Outcome|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
513474|NCT00312845|O1|Outcome|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
513475|NCT00312845|E2|Reported Event|Rituximab|375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1, and as a single dose of 375 mg/m^2 on Day 1 of Cycles 2 through 5 (for a total of 8 doses).
513476|NCT00312845|E1|Reported Event|Bortezomib + Rituximab|1.6 mg/m^2 VELCADE for Injection administered weekly on Days 1, 8, 15, and 22 of a 35-day cycle in combination with 4 doses of 375 mg/m^2 rituximab once weekly on Days 1, 8, 15, and 22 of Cycle 1 and a single dose of 375 mg/m^2 rituximab on Day 1 of Cycles 2 through 5 (for a total of 8 doses of rituximab).
513477|NCT00312728|B1|Baseline|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513478|NCT00312728|P1|Participant Flow|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513479|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513480|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513481|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513482|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513483|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513484|NCT00312728|O1|Outcome|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513485|NCT00312728|E1|Reported Event|Bevacizumab|15 mg/kg IV on the first day of each 21- to 28-day cycle (+/-4 days) in combination with first or second-line therapy
513486|NCT00312572|B3|Baseline|Total|Total of all reporting groups
513487|NCT00312572|B2|Baseline|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513488|NCT00312572|B1|Baseline|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513489|NCT00312572|P2|Participant Flow|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513490|NCT00312572|P1|Participant Flow|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513491|NCT00312572|O3|Outcome|Combined Total|Combined percentages from BTDS 10/20 and BTDS 20
513492|NCT00312572|O2|Outcome|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513493|NCT00312572|O1|Outcome|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513494|NCT00312572|E3|Reported Event|Open-label Run-in Period - Vicodin|N = 266 subjects received a stable regimen of Vicodin® in the Run-in period and were eligible for randomization if they reported a daily “average pain over the last 24 hours” score of 0 = none or 1 = mild on at least 5 of the 7 days; and used ≤ 2 doses of supplemental analgesic per day for their osteoarthritic (OA) pain. N = 204 completed the run-in.
513495|NCT00312572|E2|Reported Event|Double-blind BTDS 20|Initial doses (Level 1) of BTDS 20. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513496|NCT00312572|E1|Reported Event|Double-blind BTDS 10/20|Initial doses (Level 1) of BTDS 10. Subjects were allowed to have their dose adjusted to BTDS 20 (Level 2) on or after day 4. Subjects remained on their treatment regimen until day 14 (± 2 days) or until they discontinued from the study. Downward titration was not permitted.
513497|NCT00312494|B4|Baseline|Total|Total of all reporting groups
513498|NCT00312494|B3|Baseline|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513499|NCT00312494|B2|Baseline|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513500|NCT00312494|B1|Baseline|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513501|NCT00312494|P3|Participant Flow|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513502|NCT00312494|P2|Participant Flow|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513503|NCT00312494|P1|Participant Flow|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513504|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513505|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513506|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513507|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513508|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513509|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513510|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513511|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513512|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513513|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513514|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513515|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513516|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513520|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513521|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513522|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513523|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513524|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513525|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513526|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513527|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513528|NCT00312494|O3|Outcome|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513529|NCT00312494|O2|Outcome|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513530|NCT00312494|O1|Outcome|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513531|NCT00312494|E3|Reported Event|Placebo|Placebo (matching ziprasidone higher dose or ziprasidone lower dose) + Mood Stabilizer
513532|NCT00312494|E2|Reported Event|Ziprasidone (Lower Dose)|Ziprasidone 40 to 80 mg daily + Mood Stabilizer
513533|NCT00312494|E1|Reported Event|Ziprasidone (Higher Dose)|Ziprasidone 120 to 160 mg daily + Mood Stabilizer
513534|NCT00312377|B3|Baseline|Total|Total of all reporting groups
513535|NCT00312377|B2|Baseline|Placebo Plus Docetaxel|Placebo plus docetaxel
513536|NCT00312377|B1|Baseline|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513537|NCT00312377|P2|Participant Flow|Placebo Plus Docetaxel|Placebo tablet taken once daily plus docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
513538|NCT00312377|P1|Participant Flow|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg oral tablet taken once daily in combination with docetaxel 75 mg/m2 IVb infusion every 21 days up to a maximum of 6 cycles
513539|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513540|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513541|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513542|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513543|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513544|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513545|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513546|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513547|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513548|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513549|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513550|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513551|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513552|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513553|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513554|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513555|NCT00312377|O2|Outcome|Placebo Plus Docetaxel|Placebo plus docetaxel
513556|NCT00312377|O1|Outcome|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513557|NCT00312377|E2|Reported Event|Placebo Plus Docetaxel|Placebo plus docetaxel
513558|NCT00312377|E1|Reported Event|Vandetanib 100 mg Plus Docetaxel|Vandetanib 100 mg plus docetaxel
513559|NCT00312338|B3|Baseline|Total|Total of all reporting groups
513560|NCT00312338|B2|Baseline|Healthy Subjects|Healthy Subjects
513561|NCT00312338|B1|Baseline|Infected Patients|Infected Patients
513562|NCT00312338|P2|Participant Flow|Healthy Subjects|Healthy Subjects
513563|NCT00312338|P1|Participant Flow|Infected Patients|Infected Patients
513564|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
513565|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
513566|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
513567|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
513568|NCT00312338|O2|Outcome|Healthy Subjects|Healthy Subjects
513569|NCT00312338|O1|Outcome|Infected Patients|Infected Patients
513570|NCT00312338|E2|Reported Event|Healthy Subjects|Healthy Subjects
513571|NCT00312338|E1|Reported Event|Infected Patients|Infected Patients
513572|NCT00312221|B4|Baseline|Total|Total of all reporting groups
513573|NCT00312221|B3|Baseline|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513574|NCT00312221|B2|Baseline|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513575|NCT00312221|B1|Baseline|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513576|NCT00312221|P4|Participant Flow|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513577|NCT00312221|P3|Participant Flow|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513578|NCT00312221|P2|Participant Flow|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513579|NCT00312221|P1|Participant Flow|Run-in Period|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
513580|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513581|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513582|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
516766|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
513583|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513584|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513585|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513586|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513587|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513588|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513589|NCT00312221|O3|Outcome|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours).
513590|NCT00312221|O2|Outcome|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear
513591|NCT00312221|O1|Outcome|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear
513592|NCT00312221|E4|Reported Event|Run-in, Open-label BTDS 10 and 20|The run-in period was designed to select subjects whose pain was adequately controlled by and who tolerated BTDS 20 treatment. BTDS 10 or 20 was applied for 7-day wear during the 3-week run-in period.
513593|NCT00312221|E3|Reported Event|Double-blind Oxycodone Immediate-Release|Oxycodone immediate-release 40 mg (two 5-mg capsules every 6 hours) during the 12-week double-blind phase.
513594|NCT00312221|E2|Reported Event|Double-blind BTDS 20|Buprenorphine transdermal patch 20 mcg/h applied for 7-day wear during the 12-week double-blind phase
513595|NCT00312221|E1|Reported Event|Double-blind BTDS 5|Buprenorphine transdermal patch 5 mcg/h applied for 7-day wear during the 12-week double-blind phase
513596|NCT00312208|B3|Baseline|Total|Total of all reporting groups
513597|NCT00312208|B2|Baseline|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
513598|NCT00312208|B1|Baseline|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
513599|NCT00312208|P2|Participant Flow|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
513600|NCT00312208|P1|Participant Flow|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
513601|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
513602|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
513603|NCT00312208|O2|Outcome|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
513604|NCT00312208|O1|Outcome|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
513605|NCT00312208|E2|Reported Event|Docetaxel + Doxorubicin and Cyclophosphamide (TAC)|TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.
513606|NCT00312208|E1|Reported Event|Doxorubicin + Cyclophosphamide Followed by Docetaxel (AC -> T)|AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
513607|NCT00312195|B3|Baseline|Total|Total of all reporting groups
513608|NCT00312195|B2|Baseline|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
513609|NCT00312195|B1|Baseline|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513610|NCT00312195|P2|Participant Flow|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
513611|NCT00312195|P1|Participant Flow|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513612|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
513613|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513614|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
513615|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513616|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
513617|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513618|NCT00312195|O3|Outcome|Total|Placebo and BTDS combined.
513619|NCT00312195|O2|Outcome|Double-blind BTDS|Test drug - buprenorphine transdermal patch 5, 10 or 20 mcg/h applied for 7-day wear.
513620|NCT00312195|O1|Outcome|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513621|NCT00312195|E3|Reported Event|Open-label Run-in Period BTDS 5, 10 or 20|Buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
513622|NCT00312195|E2|Reported Event|Double-blind BTDS|Test drug - buprenorphine transdermal patch (BTDS) 5, 10, or 20 mcg/h applied for 7-day wear.
513623|NCT00312195|E1|Reported Event|Double-blind Placebo Patch|Reference drug - Placebo transdermal patch to match BTDS 5, 10, or 20 mcg/h applied for 7-day wear.
513624|NCT00311766|B3|Baseline|Total|Total of all reporting groups
513625|NCT00311766|B2|Baseline|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
513626|NCT00311766|B1|Baseline|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
513627|NCT00311766|P2|Participant Flow|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
513628|NCT00311766|P1|Participant Flow|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
513629|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
513630|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
513631|NCT00311766|O2|Outcome|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
513632|NCT00311766|O1|Outcome|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
513633|NCT00311766|E2|Reported Event|Thymosin Beta 4|"Topical administration of 0.01%, 0.03%, and 0.1% Thymosin Beta 4 gel, qd up to 56 days~Thymosin Beta 4 : Topical administration, 0.01%, 0.03%, and 0.1% gel, qd up to 56 days"
513634|NCT00311766|E1|Reported Event|Placebo|"Topical administration of placebo gel, 0% Thymosin Beta 4, qd up to 56 days~Placebo : Topical administration, 0.00% qd up to 56 days"
513635|NCT00311584|B3|Baseline|Total|Total of all reporting groups
513636|NCT00311584|B2|Baseline|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513637|NCT00311584|B1|Baseline|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513638|NCT00311584|P2|Participant Flow|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513639|NCT00311584|P1|Participant Flow|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride IV (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513640|NCT00311584|O2|Outcome|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513641|NCT00311584|O1|Outcome|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513642|NCT00311584|E2|Reported Event|Disease Measurable by CT or MRI Scan (Irinotecan/Temozolomide)|"Measurable by CT scan (Computed Tomography) or MRI scan (Magnetic Resonance Imaging). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513643|NCT00311584|E1|Reported Event|Disease Eval by Bone Marrow or MIBG (Irinotecan/Temozolomide)|"Evaluation by bone marrow or MIBG scan (metaiodobenzylguanidine scan, a radiopharmaceutical). Patients receive irinotecan hydrochloride (10 mg/m2/dose) over 1 hour on days 1-5 and 8-12 and oral temozolomide (100 mg/m2/dose) on days 1-5. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~irinotecan hydrochloride : Given IV~temozolomide : Given IV"
513644|NCT00311402|B3|Baseline|Total|Total of all reporting groups
513645|NCT00311402|B2|Baseline|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513646|NCT00311402|B1|Baseline|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513647|NCT00311402|P2|Participant Flow|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513648|NCT00311402|P1|Participant Flow|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513649|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513650|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513651|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513652|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513653|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513654|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513655|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513656|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513657|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513658|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513659|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513660|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513661|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513662|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513663|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513664|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513665|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513666|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513667|NCT00311402|O2|Outcome|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513668|NCT00311402|O1|Outcome|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513669|NCT00311402|E2|Reported Event|Acetylsalicylic Acid (ASA) 81 mg Tablet|ASA 81 mg, 1 tablet once daily
513670|NCT00311402|E1|Reported Event|Aggrenox Capsule|Aggrenox (extended-release dipyridamole 200 mg plus ASA 50 mg in a capsule), 2 capsules twice daily
513671|NCT00311376|B4|Baseline|Total|Total of all reporting groups
513672|NCT00311376|B3|Baseline|Placebo|Normal saline (placebo)
513673|NCT00311376|B2|Baseline|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513674|NCT00311376|B1|Baseline|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513675|NCT00311376|P3|Participant Flow|Placebo|Normal saline (placebo)
513676|NCT00311376|P2|Participant Flow|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513677|NCT00311376|P1|Participant Flow|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513678|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
513679|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513680|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513681|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
513682|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513683|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513684|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
513685|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513686|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513687|NCT00311376|O3|Outcome|Placebo|Normal saline (placebo)
513688|NCT00311376|O2|Outcome|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513689|NCT00311376|O1|Outcome|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513690|NCT00311376|E3|Reported Event|Placebo|Normal saline (placebo)
513691|NCT00311376|E2|Reported Event|Botulinum Toxin Type A (200U)|botulinum toxin Type A (200U)
513692|NCT00311376|E1|Reported Event|Botulinum Toxin Type A (300U)|botulinum toxin Type A (300U)
513693|NCT00311363|B4|Baseline|Total|Total of all reporting groups
513694|NCT00311363|B3|Baseline|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
513695|NCT00311363|B2|Baseline|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
513696|NCT00311363|B1|Baseline|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
513697|NCT00311363|P3|Participant Flow|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet.
513698|NCT00311363|P2|Participant Flow|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet.
513699|NCT00311363|P1|Participant Flow|Single-blind (SB) GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn).
513700|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513882|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513701|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513702|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513703|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513704|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513705|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513706|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513707|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513708|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513709|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513710|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513711|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513712|NCT00311363|O1|Outcome|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513713|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513714|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513715|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513716|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513717|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513718|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513719|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513720|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513721|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513722|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513723|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513724|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513725|NCT00311363|O2|Outcome|DB GEn 1200mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513726|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513727|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513728|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513729|NCT00311363|O2|Outcome|GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513730|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513731|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513883|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513732|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513733|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513734|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513735|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513736|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513737|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513738|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513739|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513740|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513741|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513742|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513743|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513744|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513745|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513746|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513747|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513748|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513749|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513750|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513751|NCT00311363|O2|Outcome|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513752|NCT00311363|O1|Outcome|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513753|NCT00311363|E3|Reported Event|DB GEn 1200 mg|Days 169 to 252: two 600 mg ER tablets (1200 mg GEn). Days 253 to 260, participants tapered to one 600 mg ER tablet
513754|NCT00311363|E2|Reported Event|DB Placebo|Days 169 to 182: one 600 mg ER tablet of GEn and one matching placebo tablet for a 2-week blinded taper period. Days 183 to 252: two blinded placebo tablets. Days 253 to 260, participants tapered to one placebo tablet
513755|NCT00311363|E1|Reported Event|SB GEn 1200 mg|Oral gabapentin enacarbil (GEn; XP13512/GSK1838262) 1200 milligrams (mg) once daily. Days 1 to 3: one extended release (ER) tablet (600 mg GEn). Days 4 to 168: two ER tablets (total dose of 1200 mg GEn)
513756|NCT00311311|B3|Baseline|Total|Total of all reporting groups
513757|NCT00311311|B2|Baseline|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513758|NCT00311311|B1|Baseline|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513759|NCT00311311|P2|Participant Flow|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to cyclosporine (CsA) (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
514025|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
513760|NCT00311311|P1|Participant Flow|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 nanogram per milliliter [ng/mL] by 3-6 months post-transplant) plus mycophenolate mofetil (MMF) (greater than or equal to [>=] 500 milligram per day [mg/day]) or mycophenolate sodium (MPS) (>= 360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or azathioprine (AZA) (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513761|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513762|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513763|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513764|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513765|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513766|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513767|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513768|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513769|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513770|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
514026|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
513771|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513772|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513773|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513774|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513775|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513776|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513777|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513778|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513779|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513780|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513781|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513844|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513884|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513782|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513783|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513784|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513785|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513786|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513787|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513788|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513789|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513790|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513791|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513792|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513885|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513793|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513794|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513795|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513796|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513797|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513798|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513799|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513800|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513801|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513802|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513803|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513845|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513886|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513804|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513805|NCT00311311|O2|Outcome|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513806|NCT00311311|O1|Outcome|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513807|NCT00311311|E2|Reported Event|Tacrolimus With Mycophenolate/Prednisone|Participant received TAC, target trough level of 3-10 ng/mL by 3-6 months post-transplant to end of study, plus MMF (>=500 mg/day) or MPS (>=360 mg/day) or AZA (>=50 mg/day) plus prednisone (>=2.5 mg/day), from day of transplant (Day 1) to end of study. TAC may have been converted to CsA (target CsA trough concentration [C0] level 50-250 ng/mL; target CsA concentration 2 hours post-dose [C2] level 200-1200 ng/mL) at the discretion of the investigator.
513808|NCT00311311|E1|Reported Event|Tacrolimus Then Sirolimus With Mycophenolate/Prednisone|Participant received tacrolimus (TAC), (target trough level of 3-10 ng/mL by 3-6 months post-transplant) plus MMF (>=500 mg/day) or mycophenolate sodium (MPS) (>=360 mg/day), plus prednisone (tapered to a minimum of 5 mg/day). Pre-randomization eligibility was assessed at Pre-Conversion Baseline (Weeks 12-24) and participants were randomized and assigned to treatment arm 0-14 days after Pre-Conversion Baseline. On Day 1 Conversion the participant stopped or tapered off TAC and began conversion to sirolimus (SRL- target trough level of 8-15 ng/mL through month 24 post-transplant and 5-12 ng/mL thereafter) + MMF (500-1500 mg/day) or MPS (360-1080 mg/day) or AZA (50-75 mg/day) + prednisone (minimum of 2.5 mg/day) to end of study.
513809|NCT00311181|B1|Baseline|Group 1|
513810|NCT00311181|P1|Participant Flow|Group 1|
513811|NCT00311181|O1|Outcome|Group 1|
513812|NCT00311181|O1|Outcome|Group 1|
513813|NCT00311181|O1|Outcome|Group 1|
513814|NCT00311181|E1|Reported Event|Group 1|
513815|NCT00311155|B1|Baseline|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
513816|NCT00311155|P1|Participant Flow|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
513817|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
513818|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
513819|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
513820|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
514022|NCT00309777|P3|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
513821|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
513822|NCT00311155|O1|Outcome|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olmesartan (OLM) 20 mg to start for 4 weeks. Hydrochlorothiazide (HCTZ) 12.5 mg is added, if necessary, for 4 additional weeks. Hydrochlorothiazide is doubled (25 mg), if necessary, for 4 additional weeks. If blood pressure goals were still not achieved, amlodipine (AML) 5 mg was added to the olmesartan and hydroclorothiazide for an additional 4 weeks. Finally, the amplodine was doubled (10 mg), if needed, for the final 4 weeks of treatment. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg. The subject's participation in the study was concluded as soon as blood pressure goals were met.
513823|NCT00311155|E1|Reported Event|Olmesartan+Hydrochlorothiazide,if Needed+Amlodipine, if Needed|Olemesartan 20 mg to start. Hydrochlorothiazide 12.5 mg and then 25 mg was added, if necessary. If blood pressure goal was still not achieved, amlodipine 5 mg and then 10 mg were added, if needed. Thus, the maximum combination was olmesartan 20mg + hydrochlorothiazide 25mg + amlodipine 10mg.
513824|NCT00310856|B4|Baseline|Total|Total of all reporting groups
513825|NCT00310856|B3|Baseline|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513826|NCT00310856|B2|Baseline|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513827|NCT00310856|B1|Baseline|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513828|NCT00310856|P3|Participant Flow|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose of MenC-CRM (at 12 months of age) and 1 dose of MenACWY-CRM (at 18 months of age).~Subjects also received routine vaccines: 1 dose of PCV7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513829|NCT00310856|P2|Participant Flow|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
513830|NCT00310856|P1|Participant Flow|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM (1 dose at 6 and 12 months of age). Subjects also received routine vaccines: 2 doses of PC7 (1 dose at 6 and 12 months of age), 1 dose of DTaP-Hib-IPV (at 6 months of age) and 1 dose of MMR+Varicella (at 13 months of age).
513831|NCT00310856|O3|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513832|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513833|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513834|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513835|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513836|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513837|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513838|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513839|NCT00310856|O1|Outcome|MenC-CRM_12 M_MenACWY-CRM_18 M|"Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months).~Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib-IPV (at 18 months)."
513840|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513841|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513842|NCT00310856|O2|Outcome|MenACWY-CRM_12 M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513843|NCT00310856|O1|Outcome|MenACWY-CRM_6-12 M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months).
513846|NCT00310856|E3|Reported Event|MenC-CRM_12M_MenACWY-CRM_18M|Subjects received 1 dose each of MenC-CRM (at 12 months) and MenACWY-CRM (at 12 months). Subjects also received routine vaccines: 1 dose each of PC7 (at 12 months), MMR+Varicella (at 13 months) and DTaP-Hib- IPV (at 18 months)
513847|NCT00310856|E2|Reported Event|MenACWY-CRM_12M|Subjects received 1 dose of MenACWY-CRM at 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
513848|NCT00310856|E1|Reported Event|MenACWY-CRM_6-12M|Subjects received 2 doses of MenACWY-CRM at 6 and 12 months of age. Subjects also received routine vaccines: 2 doses of PC7 (at 6 and 12 months) and 1 dose each of DTaP-Hib-IPV (at 6 months) and MMR+Varicella (at 13 months)
513849|NCT00310817|B5|Baseline|Total|Total of all reporting groups
513850|NCT00310817|B4|Baseline|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
513851|NCT00310817|B3|Baseline|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
513852|NCT00310817|B2|Baseline|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513853|NCT00310817|B1|Baseline|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513854|NCT00310817|P4|Participant Flow|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
513855|NCT00310817|P3|Participant Flow|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
513856|NCT00310817|P2|Participant Flow|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513857|NCT00310817|P1|Participant Flow|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513858|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
513859|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
513860|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513861|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513862|NCT00310817|O4|Outcome|MenACWY-PS 36 to 59 Months|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
513863|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 169 or day 337.
513864|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513865|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513866|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513867|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513868|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513869|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513870|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513871|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513872|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513873|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513874|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513875|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513876|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MEnACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513877|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MEnACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513878|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513879|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513880|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513881|NCT00310817|O3|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513887|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513888|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) (12-35M12- )|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513889|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513890|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513891|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513892|NCT00310817|O4|Outcome|MenACWY-CRM(Ad-) 12-35M12-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 12 months after the first vaccination.
513893|NCT00310817|O3|Outcome|MenACWY-CRM(Ad-) 12-35M6-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose at 6 months after the first vaccination.
513894|NCT00310817|O2|Outcome|MenACWY-CRM(Ad+) 12-35M12+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 12 months after the first vaccination.
513895|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M6+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 6 months after the first vaccination.
513896|NCT00310817|O2|Outcome|MenACWY-CRM (Ad-)12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513897|NCT00310817|O1|Outcome|MenACWY-CRM (Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513898|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513899|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513900|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) 12-35M1-|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513901|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) 12-35M1+|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 28 (1 month after the first vaccination).
513902|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513903|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine with on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513904|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513905|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513906|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513907|NCT00310817|O1|Outcome|MenACWY-CRM(Ad+) (12 to 35 Months)|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513908|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
513909|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
513910|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
513911|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513912|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 358 (12 months after first vaccination).
513913|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) on day 169 (6 months after first vaccination).
513914|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
513915|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513916|NCT00310817|O4|Outcome|MeMenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
513917|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
513918|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
513919|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513920|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
513921|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
513922|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
514023|NCT00309777|P2|Participant Flow|Simvastatin 20 mg|Simvastatin 20 mg once daily
513923|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513924|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
513925|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
513926|NCT00310817|O2|Outcome|MenACWY-CRM(Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
513927|NCT00310817|O1|Outcome|MenACWY-CRM(Ad)- (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513928|NCT00310817|O4|Outcome|MenACWY-PS (36-59 M12PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(-Ad) vaccine on day 358 (12 months after first vaccination).
513929|NCT00310817|O3|Outcome|MenACWY-PS (36-59 M6PS)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 (6 months after first vaccination).
513930|NCT00310817|O2|Outcome|MenACWY-CRM( Ad-) (36 to 59 M12-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 358 (12 months after the first vaccination).
513931|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 M6-)|Subjects received two doses of MenACWY-CRM(Ad-) on day 1 and day 169 (6 months after the first vaccination).
513932|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
513933|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
513934|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-) vaccine on day 169 or day 337.
513935|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337
513936|NCT00310817|O2|Outcome|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY-CRM(Ad-)vaccine on day 169 or day 337.
513937|NCT00310817|O1|Outcome|MenACWY-CRM(Ad-) (36 to 59 Months)|Subjects received one dose of MenACWY-CRM(Ad-) vaccine on day 1 and second vaccination on day 169 or day 337.
513938|NCT00310817|E4|Reported Event|MenACWY-PS (36 to 59 Months)|Subjects received one dose of MenACWY-PS vaccine on day 1 and second dose of MenACWY conjugate vaccine without adjuvant on day 169 or day 337.
513939|NCT00310817|E3|Reported Event|MenACWY-CRM(Ad-) 36 to 59 Months|Subjects received one dose of MenACWY-CRM(Ad+) vaccine on day 1 and second dose on day 169 or day 337.
513940|NCT00310817|E2|Reported Event|MenACWY-CRM(Ad-) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad-)vaccine on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.
513941|NCT00310817|E1|Reported Event|MenACWY-CRM(Ad+) 12 to 35 Months|Subjects received one dose of MenACWY-CRM(Ad+)vaccine on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.
513942|NCT00310804|B3|Baseline|Total|Total of all reporting groups
513943|NCT00310804|B2|Baseline|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513944|NCT00310804|B1|Baseline|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513945|NCT00310804|P2|Participant Flow|TIV Group|Subjects in this group received one dose of Egg derived Trivalent Subunit Influenza Vaccine (TIV).
513946|NCT00310804|P1|Participant Flow|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513947|NCT00310804|O4|Outcome|TIV Group Day 23 to Day 181|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513948|NCT00310804|O3|Outcome|TIV Group Day 1 to Day 22|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513949|NCT00310804|O2|Outcome|cTIV (Combined) Day 23 to Day 181|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513950|NCT00310804|O1|Outcome|cTIV (Combined) Day 1 to Day 22|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot 1, Lot2 or Lot3).
513951|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513952|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513953|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
513954|NCT00310804|O2|Outcome|cTIV_lot2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
513955|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
513956|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513957|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513958|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from lot 3.
513959|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
513960|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
513961|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513962|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513963|NCT00310804|O3|Outcome|cTIV_lot 3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
513964|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
513965|NCT00310804|O1|Outcome|cTIV_lot 1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
513966|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg-Derived Trivalent Subunit Influenza Vaccine(TIV).
513967|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513968|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
513969|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2.
513970|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
513971|NCT00310804|O5|Outcome|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513972|NCT00310804|O4|Outcome|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513973|NCT00310804|O3|Outcome|cTIV_lot3|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 3.
513974|NCT00310804|O2|Outcome|cTIV_lot 2|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 2
513975|NCT00310804|O1|Outcome|cTIV_lot1|Subjects in this group received one dose of Cell-Derived Trivalent Subunit Influenza Vaccine (cTIV) from Lot 1.
513976|NCT00310804|E2|Reported Event|TIV Group|Subjects in this group received one dose of Egg Derived Trivalent Subunit Influenza Vaccine (TIV).
513977|NCT00310804|E1|Reported Event|cTIV (Combined)|Subjects in this group received one dose of Cell Derived Trivalent Subunit Influenza Vaccine from one of three vaccine Lots (Lot1, Lot2 or Lot3).
513978|NCT00310791|B3|Baseline|Total|Total of all reporting groups
513979|NCT00310791|B2|Baseline|Active|
513980|NCT00310791|B1|Baseline|Placebo|
513981|NCT00310791|P2|Participant Flow|Active|
513982|NCT00310791|P1|Participant Flow|Placebo|
513983|NCT00310791|O2|Outcome|Active|DHEA+HRT
513984|NCT00310791|O1|Outcome|Placebo|Sugar Pill
513985|NCT00310791|E2|Reported Event|Active|
513986|NCT00310791|E1|Reported Event|Placebo|
513987|NCT00309985|B3|Baseline|Total|Total of all reporting groups
513988|NCT00309985|B2|Baseline|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513989|NCT00309985|B1|Baseline|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
513990|NCT00309985|P2|Participant Flow|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513991|NCT00309985|P1|Participant Flow|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
513992|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513993|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
513994|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513995|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
513996|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513997|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
513998|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
513999|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
514024|NCT00309777|P1|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
514000|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
514001|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
514002|NCT00309985|O2|Outcome|Androgen-Deprivation Therapy Alone|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
514003|NCT00309985|O1|Outcome|Androgen-Deprivation Therapy and Docetaxel|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
514004|NCT00309985|E2|Reported Event|Arm B|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration).
514005|NCT00309985|E1|Reported Event|Arm A|Patients receive androgen-deprivation therapy (including luteinizing hormone-releasing hormone [LHRH] agonist therapy, LHRH antagonist therapy, or surgical castration). Patients also receive docetaxel IV over 1 hour on day 1. Treatment with docetaxel repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
514006|NCT00309946|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514007|NCT00309946|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514008|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514009|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514010|NCT00309946|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514011|NCT00309946|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
514012|NCT00309907|B1|Baseline|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
514013|NCT00309907|P1|Participant Flow|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
514014|NCT00309907|O1|Outcome|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
514015|NCT00309907|E1|Reported Event|Etanercept and Corticosteroid Therapy|"Patients receive etanercept IV (dose 0.4 mg/kg- max 25 mg) over 30 minutes on day 0 and subcutaneously (dose 0.4 mg/kg- max 25 mg) on days 3, 7, 10, 14, 17, 21, and 24. Treatment continues in the absence of an infectious pathogen, disease progression, or unacceptable toxicity. Patients also receive methylprednisolone (or corticosteroid equivalent) IV (dose 2.0 mg/kg/day) on days 0-2 and then orally with a taper beginning day 7. Dose on days 7-20 (1.0 mg/kg/day), days 21-34 (0.5 mg/kg/day), days 35-48 (0.25 mg/kg/day) and days 49-56 (0.25 mg/kg/every other day) discontinuing on day 56.~etanercept: Given IV and subcutaneously~methylprednisolone: Given IV and orally"
514016|NCT00309777|B5|Baseline|Total|Total of all reporting groups
514017|NCT00309777|B4|Baseline|Simvastatin 40 mg|Simvastatn 40 mg once daily
514018|NCT00309777|B3|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
514019|NCT00309777|B2|Baseline|Simvastatin 20 mg|Simvastatin 20 mg once daily
514020|NCT00309777|B1|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
514021|NCT00309777|P4|Participant Flow|Simvastatin 40 mg|Simvastatn 40 mg once daily
514027|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
514028|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
514029|NCT00309777|O4|Outcome|Simvastatin 40 mg|Simvastatn 40 mg once daily
514030|NCT00309777|O3|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
514031|NCT00309777|O2|Outcome|Simvastatin 20 mg|Simvastatin 20 mg once daily
514032|NCT00309777|O1|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
514033|NCT00309777|E4|Reported Event|Simvastatin 40 mg|Simvastatn 40 mg once daily
514034|NCT00309777|E3|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
514035|NCT00309777|E2|Reported Event|Simvastatin 20 mg|Simvastatin 20 mg once daily
514036|NCT00309777|E1|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
514037|NCT00310466|B3|Baseline|Total|Total of all reporting groups
514038|NCT00310466|B2|Baseline|Placebo|Corresponding placebo for sublingual administration
514039|NCT00310466|B1|Baseline|SLITone Birch|Birch pollen extract for sublingual administration
514040|NCT00310466|P2|Participant Flow|Placebo|Corresponding placebo for sublingual administration
514041|NCT00310466|P1|Participant Flow|SLITone Birch|Birch pollen extract for sublingual administration
514042|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
514043|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
514044|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
514045|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
514046|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
514047|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
514048|NCT00310466|O2|Outcome|Placebo|Corresponding placebo for sublingual administration
514049|NCT00310466|O1|Outcome|SLITone Birch|Birch pollen extract for sublingual administration
514050|NCT00310466|E2|Reported Event|Placebo|Corresponding placebo for sublingual administration
514051|NCT00310466|E1|Reported Event|SLITone Birch|Birch pollen extract for sublingual administration
514052|NCT00310440|B3|Baseline|Total|Total of all reporting groups
514053|NCT00310440|B2|Baseline|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514054|NCT00310440|B1|Baseline|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514055|NCT00310440|P2|Participant Flow|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514056|NCT00310440|P1|Participant Flow|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514057|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514058|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514059|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514060|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514061|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514062|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514063|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514090|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514091|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514064|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514065|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514066|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514067|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514068|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514069|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514070|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514071|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514072|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514073|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514074|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514075|NCT00310440|O2|Outcome|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514076|NCT00310440|O1|Outcome|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514077|NCT00310440|E2|Reported Event|Autologous Bone|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with local autologous bone.~Autologous bone: Local autologous bone will be harvested, milled and placed into the cavity of the structural allograft ring"
514078|NCT00310440|E1|Reported Event|Bone Graft Substitute|"Subjects will receive anterior cervical discectomy with fusion and instrumentation (anterior plate). Structural allograft ring will be used. The cavity of the ring will be filled with P-15 synthetic osteoconductive bone substitute (investigational device).~P-15 Synthetic osteoconductive bone substitute: Safety and efficacy of synthetic bone substitute used for fusion in spinal surgery"
514079|NCT00310427|B3|Baseline|Total|Total of all reporting groups
514080|NCT00310427|B2|Baseline|Placebo|Subjects received placebo orally on a daily basis.
514081|NCT00310427|B1|Baseline|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514082|NCT00310427|P2|Participant Flow|Placebo|Subjects received placebo orally on a daily basis.
514083|NCT00310427|P1|Participant Flow|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514084|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514085|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514086|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514087|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514088|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514089|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514092|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514093|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514094|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514095|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514096|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514097|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514098|NCT00310427|O2|Outcome|Placebo|Subjects received placebo orally on a daily basis.
514099|NCT00310427|O1|Outcome|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514100|NCT00310427|E2|Reported Event|Placebo|Subjects received placebo orally on a daily basis.
514101|NCT00310427|E1|Reported Event|LY686017|Subjects received 50 mg of the NK1 antagonist LY686017 orally on a daily basis
514102|NCT00310401|B3|Baseline|Total|Total of all reporting groups
514103|NCT00310401|B2|Baseline|Saline|
514104|NCT00310401|B1|Baseline|Albuterol|
514105|NCT00310401|P2|Participant Flow|Saline|
514106|NCT00310401|P1|Participant Flow|Albuterol|
514107|NCT00310401|O2|Outcome|Saline|
514108|NCT00310401|O1|Outcome|Albuterol|
514109|NCT00310401|E2|Reported Event|Saline|
514110|NCT00310401|E1|Reported Event|Albuterol|
514111|NCT00310375|B3|Baseline|Total|Total of all reporting groups
514112|NCT00310375|B2|Baseline|Retigabine in Parent Study|
514113|NCT00310375|B1|Baseline|Placebo in Parent Study|
514114|NCT00310375|P2|Participant Flow|Retigabine in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation until withdrawal, withdrawn consent or switched to commercial product. Participants who received retigabine in parent study are included in this arm.
514115|NCT00310375|P1|Participant Flow|Placebo in Parent Study|Participants received retigabine tablets as a total dose of between 600 to 1200 mg/day (dose administered twice daily or Thrice daily [TID]) as an adjunct therapy to their ongoing antiepileptic drugs (AEDs) with or without vagal nerve stimulation (VNS) until withdrawal, withdrawn consent or switched to commercial product. Participants who received placebo in parent study are included in this arm.
514116|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514117|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514118|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514119|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514120|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514121|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514122|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514123|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514124|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514125|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514126|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514127|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514191|NCT00309608|B6|Baseline|Total|Total of all reporting groups
514192|NCT00309608|B5|Baseline|Glimepiride|Patients randomized to receive treatment with Glimepiride
514128|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514129|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514130|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514131|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514132|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514133|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514134|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514135|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514136|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514137|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514138|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514139|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514140|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514141|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514142|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514143|NCT00310375|O1|Outcome|Overall Study Arm|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514144|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514145|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514146|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514147|NCT00310375|O1|Outcome|Overall Study|
514148|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514149|NCT00310375|O1|Outcome|Overall Study|
514193|NCT00309608|B4|Baseline|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
516767|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
514150|NCT00310375|O1|Outcome|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514151|NCT00310375|E1|Reported Event|Overall Study|Participants received retigabine tablets for a total dose of between 600 to 1200 mg/day (dose administered twice daily or TID) as an adjunct therapy to their ongoing antiepileptic drugs with or without vagal nerve stimulation treatment until withdrawal, withdrawn consent or switched to commercial product.
514152|NCT00310362|B4|Baseline|Total|Total of all reporting groups
514153|NCT00310362|B3|Baseline|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514154|NCT00310362|B2|Baseline|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures..
514155|NCT00310362|B1|Baseline|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
514156|NCT00310362|P3|Participant Flow|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514157|NCT00310362|P2|Participant Flow|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514158|NCT00310362|P1|Participant Flow|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
514159|NCT00310362|O3|Outcome|IVR7|Arm 3 (IVR7) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514160|NCT00310362|O2|Outcome|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514161|NCT00310362|O1|Outcome|Usual Care|Usual care included nurse phone calls to participants 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and opportunities for education on preparation procedures.
514162|NCT00310362|E3|Reported Event|IVR7|Arm 2 (IVR3) included interactive voice response calls delivered to patients 7 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514163|NCT00310362|E2|Reported Event|IVR3|Arm 2 (IVR3) included interactive voice response calls delivered to patients 3 days prior to the scheduled appointment. Calls were intended as appointment reminders and as interactive, but pre-recorded, opportunities for education on preparation procedures.
514164|NCT00310362|E1|Reported Event|Usual Care|Usual Care--Nurses telephoned patients 7 days prior to appointment to remind patients about scheduled GI appointment and to answer any questions.
514165|NCT00310076|B1|Baseline|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
514166|NCT00310076|P1|Participant Flow|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
514167|NCT00310076|O1|Outcome|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
514168|NCT00310076|E1|Reported Event|Chemo Therapy Followed by Thalidomide|After cytoreductive surgery with intraperitoneal hyperthermic chemotherapy, patients will receive thalidomide orally each evening for 24 months or until tumor progression is detected.
514169|NCT00309751|B3|Baseline|Total|Total of all reporting groups
514170|NCT00309751|B2|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
514171|NCT00309751|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514172|NCT00309751|P2|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
514173|NCT00309751|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514174|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
514175|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514176|NCT00309751|O2|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
514177|NCT00309751|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514178|NCT00309751|E2|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg once daily
514179|NCT00309751|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514180|NCT00309738|B3|Baseline|Total|Total of all reporting groups
514181|NCT00309738|B2|Baseline|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
514182|NCT00309738|B1|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514183|NCT00309738|P2|Participant Flow|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
514184|NCT00309738|P1|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514185|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
514186|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514187|NCT00309738|O2|Outcome|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
514188|NCT00309738|O1|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514189|NCT00309738|E2|Reported Event|Simvastatin 40 mg QD|Simvastatin 40 mg once daily
514190|NCT00309738|E1|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg once daily
514194|NCT00309608|B3|Baseline|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514195|NCT00309608|B2|Baseline|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514196|NCT00309608|B1|Baseline|Placebo|Patients randomized to receive treatment with matching placebo
514197|NCT00309608|P5|Participant Flow|Glimepiride|Patients randomized to receive treatment with Glimepiride
514198|NCT00309608|P4|Participant Flow|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
514199|NCT00309608|P3|Participant Flow|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514200|NCT00309608|P2|Participant Flow|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514201|NCT00309608|P1|Participant Flow|Placebo|Patients randomized to receive treatment with matching placebo
514202|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
514203|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514204|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514205|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
514206|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
514207|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
514208|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514209|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514210|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
514211|NCT00309608|O5|Outcome|Glimepiride|Patients randomized to receive treatment with Glimepiride
514212|NCT00309608|O4|Outcome|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
514213|NCT00309608|O3|Outcome|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514214|NCT00309608|O2|Outcome|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514215|NCT00309608|O1|Outcome|Placebo|Patients randomized to receive treatment with matching placebo
514216|NCT00309608|E5|Reported Event|Glimepiride|Patients randomized to receive treatment with Glimepiride
514217|NCT00309608|E4|Reported Event|Linagliptin 10 mg|Patients randomized to receive treatment with Linagliptin 10 mg
514218|NCT00309608|E3|Reported Event|Linagliptin 5 mg|Patients randomized to receive treatment with Linagliptin 5 mg
514219|NCT00309608|E2|Reported Event|Linagliptin 1 mg|Patients randomized to receive treatment with Linagliptin 1 mg
514220|NCT00309608|E1|Reported Event|Placebo|Patients randomized to receive treatment with matching placebo
514221|NCT00309465|B7|Baseline|Total|Total of all reporting groups
514222|NCT00309465|B6|Baseline|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
514223|NCT00309465|B5|Baseline|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
514224|NCT00309465|B4|Baseline|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
514225|NCT00309465|B3|Baseline|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was > or = 150 mg/dl.
514226|NCT00309465|B2|Baseline|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
514227|NCT00309465|B1|Baseline|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
514228|NCT00309465|P6|Participant Flow|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was <150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was > or = 150 mg/dl.
514229|NCT00309465|P5|Participant Flow|Call Physician (Insulin Glargine Plus Bolus Group|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
514230|NCT00309465|P4|Participant Flow|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
514231|NCT00309465|P3|Participant Flow|Dose Table (Insulin Glargine Only Group)|Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was < 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was > or = 150 mg/dl.
514232|NCT00309465|P2|Participant Flow|Call Physician (Insulin Glargine Only Group)|Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
514233|NCT00309465|P1|Participant Flow|Take 80% (Insulin Glargine Only Group)|Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
514234|NCT00309465|O6|Outcome|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was <150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was > or = 150 mg/dl
514235|NCT00309465|O5|Outcome|Call Physician (Insulin Glargine Plus Bolus Group|Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
514236|NCT00309465|O4|Outcome|Take 80% (Insulin Glargine Plus Bolus Group)|Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
514237|NCT00309465|O3|Outcome|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was > or = 150 mg/dl
514238|NCT00309465|O2|Outcome|Call Physician (Insulin Glargine Only Group)|Subjects called their own physicians for insulin glargine dose on the evening before surgery
514239|NCT00309465|O1|Outcome|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
514240|NCT00309465|E6|Reported Event|Dose Table (Insulin Glargine Plus Bolus Group)|Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was <150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was < or =150 mg/dl.
514241|NCT00309465|E5|Reported Event|Call Physician (Insulin Glargine Plus Bolus Group)|Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
514242|NCT00309465|E4|Reported Event|Take 80% (Insuling Glargine Plus Bolus Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
514243|NCT00309465|E3|Reported Event|Dose Table (Insulin Glargine Only Group)|Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose <150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose > or =150 mg/dl
514244|NCT00309465|E2|Reported Event|Call Physician (Insulin Glargine Only Group)|Subjects called physician for the insulin glargine dose on the evening before surgery.
514245|NCT00309465|E1|Reported Event|Take 80% (Insulin Glargine Only Group)|Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
514246|NCT00309452|B3|Baseline|Total|Total of all reporting groups
514247|NCT00309452|B2|Baseline|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514248|NCT00309452|B1|Baseline|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514249|NCT00309452|P2|Participant Flow|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514250|NCT00309452|P1|Participant Flow|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514251|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514252|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514253|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514254|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514302|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514303|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514304|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
516768|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
514255|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514256|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514257|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514258|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514259|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514260|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514261|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514262|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514263|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514264|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514265|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514266|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514305|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514306|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514267|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514268|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514269|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514270|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514271|NCT00309452|O2|Outcome|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514272|NCT00309452|O1|Outcome|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514273|NCT00309452|E2|Reported Event|STEP Care|"Integrated and comprehensive treatment provided by a specialized team in a public mental health center.Interventions include pharmacotherapy, family education, cognitive behavioral group and individual psychotherapy and case management focused on vocational rehabilitation.~Cognitive Behavioral Group Therapy: once per week~Cognitive remediation: as needed~Medications: Individualized prescription of psychotropic medications including but not restricted to antipsychotic, antidepressant and mood stabilizers.~MFG: Multi-Family psychoeducation Group based on the model published by McFarlane et al.~Assertive case management: Meetings with an individual clinician (social work or nursing) who provides supportive psychotherapy, helps assist with vocational and educational supports."
514274|NCT00309452|E1|Reported Event|Treatment as Usual|"Referral to community providers.~Treatment as Usual in the community: Subjects randomized to this arm either return to their existing outpatient psychiatrist or, if they do not have one yet, are referred by the clinic to preferred providers in the community. The nature of the interventions provided is variable and is being monitored by the research clinic."
514275|NCT00309387|B3|Baseline|Total|Total of all reporting groups
514276|NCT00309387|B2|Baseline|Placebo|
514277|NCT00309387|B1|Baseline|Treatment|
514278|NCT00309387|P2|Participant Flow|Placebo|
514279|NCT00309387|P1|Participant Flow|Treatment|
514280|NCT00309387|O2|Outcome|Placebo|Placebo
514281|NCT00309387|O1|Outcome|Treatment|Centrum
514282|NCT00309387|O2|Outcome|Placebo|Placebo
514283|NCT00309387|O1|Outcome|Treatment|Centrum
514284|NCT00309387|O2|Outcome|Placebo|Placebo
514285|NCT00309387|O1|Outcome|Treatment|Centrum
514286|NCT00309387|O2|Outcome|Placebo|placebo
514287|NCT00309387|O1|Outcome|Treatment|Centrum
514288|NCT00309387|O2|Outcome|Placebo|Placebo
514289|NCT00309387|O1|Outcome|Treatment|Centrum
514290|NCT00309387|O2|Outcome|Placebo|Placebo
514291|NCT00309387|O1|Outcome|Treatment|Centrum
514292|NCT00309387|E2|Reported Event|Placebo|
514293|NCT00309387|E1|Reported Event|Treatment|
514294|NCT00309244|B3|Baseline|Total|Total of all reporting groups
514295|NCT00309244|B2|Baseline|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514296|NCT00309244|B1|Baseline|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514297|NCT00309244|P2|Participant Flow|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart subcutaneous injection (rDNA origin), administered twice daily (before breakfast and before main evening meal). Doses are individualized for each patient.
514298|NCT00309244|P1|Participant Flow|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder (administered at each meal) + subcutaneous insulin glargine (administered once daily at bedtime). Doses are individualized for each patient.
514299|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514300|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514301|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514307|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514308|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514309|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514310|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514311|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514312|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514313|NCT00309244|O2|Outcome|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514314|NCT00309244|O1|Outcome|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514315|NCT00309244|E2|Reported Event|BPR 70/30|70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
514316|NCT00309244|E1|Reported Event|TI + Insulin Glargine|Technosphere® Insulin Inhalation Powder + Insulin glargine
514317|NCT00308997|B3|Baseline|Total|Total of all reporting groups
514318|NCT00308997|B2|Baseline|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514319|NCT00308997|B1|Baseline|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514320|NCT00308997|P2|Participant Flow|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514321|NCT00308997|P1|Participant Flow|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514322|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514323|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514324|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514325|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514326|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514327|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514328|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514329|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514330|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514331|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514332|NCT00308997|O2|Outcome|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514333|NCT00308997|O1|Outcome|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514334|NCT00308997|E2|Reported Event|Placebo Arm|"sham rTMS to Wernicke's area and a right homologous area~1-hertz Repetitive Transcranial Magnetic Stimulation : Sham stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514335|NCT00308997|E1|Reported Event|Active Arm|"Active 1-hertz Repetitive Transcranial Magnetic Stimulation to Wernicke's area and right homologous area~Active 1-Hertz Repetitive transcranial magnetic stimulation : Active stimulation given to Wernicke's area or a right homologous area for 16 minutes per day x 5 days for week I, the same for week II with switch from right to left or left to right, and 5 more stimulation sessions (16 minutes per session) to the side producing greater benefit for week III."
514336|NCT00308737|B4|Baseline|Total|Total of all reporting groups
514337|NCT00308737|B3|Baseline|Non-diabetes|Subjects without abnormalities in glucose control
514338|NCT00308737|B2|Baseline|Usual Care|Usual care
514339|NCT00308737|B1|Baseline|Technosphere® Insulin|Technosphere Insulin
514340|NCT00308737|P3|Participant Flow|Non-diabetes|Subjects without abnormalities in glucose control
514341|NCT00308737|P2|Participant Flow|Usual Care|Usual care may consist of oral anti-diabetic medications, basal insulin, subcutaneous prandial insulin, or any combination of the previous.
514342|NCT00308737|P1|Participant Flow|Technosphere® Insulin|Technosphere Insulin with or without basal insulin, or oral anti-diabetic medications, or any combination of the previous.
514343|NCT00308737|O2|Outcome|Usual Care|Usual care
514344|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514345|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514346|NCT00308737|O2|Outcome|Usual Care|Usual care
514347|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514348|NCT00308737|O2|Outcome|Usual Care|Usual care
514349|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514350|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514351|NCT00308737|O2|Outcome|Usual Care|Usual care
514352|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514353|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514354|NCT00308737|O2|Outcome|Usual Care|Usual care
514355|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514356|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514357|NCT00308737|O2|Outcome|Usual Care|Usual care
514358|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514359|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514360|NCT00308737|O2|Outcome|Usual Care|Usual care
514361|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514362|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514363|NCT00308737|O2|Outcome|Usual Care|Usual care
514364|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514365|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514366|NCT00308737|O2|Outcome|Usual Care|Usual care
514367|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514368|NCT00308737|O3|Outcome|Non-diabetes|Subjects without abnormalities in glucose control
514369|NCT00308737|O2|Outcome|Usual Care|Usual care
514370|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514371|NCT00308737|O2|Outcome|Usual Care|Usual care
514372|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514373|NCT00308737|O2|Outcome|Usual Care|Usual care
514374|NCT00308737|O1|Outcome|Technosphere® Insulin|Technosphere Insulin
514375|NCT00308737|E3|Reported Event|Non-diabetes|Subjects without abnormalities in glucose control
514376|NCT00308737|E2|Reported Event|Usual Care|Usual care (taking insulin)
514377|NCT00308737|E1|Reported Event|Technosphere® Insulin|Technosphere Insulin
514378|NCT00308711|B4|Baseline|Total|Total of all reporting groups
514379|NCT00308711|B3|Baseline|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514380|NCT00308711|B2|Baseline|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514381|NCT00308711|B1|Baseline|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514382|NCT00308711|P3|Participant Flow|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514383|NCT00308711|P2|Participant Flow|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514384|NCT00308711|P1|Participant Flow|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514385|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514386|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514387|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514388|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514389|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514390|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514391|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514392|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514393|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514394|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514395|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514396|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514397|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514398|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514399|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514400|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514401|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514402|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514403|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514404|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514405|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514406|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514407|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514408|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514409|NCT00308711|O3|Outcome|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514410|NCT00308711|O2|Outcome|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514411|NCT00308711|O1|Outcome|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514412|NCT00308711|E3|Reported Event|Cervidil 10 mg Vaginal Insert|Cervidil 10 mg vaginal insert over a period of up to 24h
514413|NCT00308711|E2|Reported Event|Misoprostol Vaginal Insert (MVI) 50|Misoprostol vaginal insert 50 mcg over a period of up to 24 h
514414|NCT00308711|E1|Reported Event|Misoprostol Vaginal Insert (MVI) 100|Misoprostol vaginal insert 100 mcg over a period of up to 24 h
514415|NCT00308620|B4|Baseline|Total|Total of all reporting groups
514416|NCT00308620|B3|Baseline|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
514417|NCT00308620|B2|Baseline|Placebo|Placebo once daily for 8 weeks
514418|NCT00308620|B1|Baseline|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
514419|NCT00308620|P3|Participant Flow|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
514420|NCT00308620|P2|Participant Flow|Placebo|Placebo once daily for 8 weeks
514421|NCT00308620|P1|Participant Flow|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
514422|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
514423|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 500mg orally once daily x 8 weeks
514424|NCT00308620|O2|Outcome|Placebo|Placebo orally once daily for 8 weeks
514425|NCT00308620|O1|Outcome|Chloroquine 250mg or 500mg|Chloroquine 250mg or 500mg orally once daily x 8 weeks. n=6 for 250mg; n=3 for 500mg
514426|NCT00308620|E3|Reported Event|Chloroquine 250mg|Chloroquine 250mg PO once daily x 8 weeks
514427|NCT00308620|E2|Reported Event|Placebo|Placebo once daily for 8 weeks
514428|NCT00308620|E1|Reported Event|Chloroquine 500mg|Chloroquine 500mg PO once daily x 8 weeks
514429|NCT00308581|B1|Baseline|Overall|Overall Induction
514430|NCT00308581|P3|Participant Flow|Overall|Overall Induction
514431|NCT00308581|P2|Participant Flow|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514432|NCT00308581|P1|Participant Flow|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514433|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514434|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514435|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514436|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514437|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514438|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514439|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514440|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514441|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514442|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514443|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514444|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514445|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514446|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514447|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514448|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514449|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514450|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514451|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514452|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514453|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514454|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514455|NCT00308581|O1|Outcome|Overall|Overall Induction
514456|NCT00308581|O1|Outcome|Overall|Overall Induction
514457|NCT00308581|O1|Outcome|Overall|Overall Induction
514458|NCT00308581|O1|Outcome|Overall|Overall Induction
514459|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514460|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514461|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514462|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514463|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514464|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514465|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514466|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514467|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514468|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514469|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514470|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514471|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514472|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514473|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514474|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514475|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514476|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514477|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514478|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514479|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514480|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514481|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514482|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514483|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514484|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514485|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514486|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514487|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514488|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514489|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514490|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514491|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514492|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514493|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514494|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514495|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514496|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514497|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514498|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514499|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514500|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514501|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514502|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514503|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514504|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514505|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514506|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514507|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514508|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514509|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514510|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514511|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514512|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514513|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514514|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514515|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514516|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514517|NCT00308581|O1|Outcome|Overall|Overall Induction
514518|NCT00308581|O1|Outcome|Overall|Overall Induction
514519|NCT00308581|O1|Outcome|Overall|Overall Induction
514520|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514521|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514522|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514523|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514524|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514525|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514526|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514527|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514528|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514529|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514530|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514531|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514532|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514533|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514534|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514535|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514536|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514537|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514538|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514539|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514540|NCT00308581|O1|Outcome|Overall|Overall Induction
514541|NCT00308581|O1|Outcome|Overall|Overall Induction
514542|NCT00308581|O1|Outcome|Overall|Overall Induction
514543|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514544|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514545|NCT00308581|O1|Outcome|Overall|Overall Induction
514546|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514547|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514548|NCT00308581|O1|Outcome|Overall|Overall Induction
514549|NCT00308581|O2|Outcome|Q2W Regimen|every 2 weeks: 400 mg Certolizumab Pegol
514550|NCT00308581|O1|Outcome|Q4W Regimen|every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol
514551|NCT00308581|O1|Outcome|Overall|Overall Induction
514552|NCT00308581|E3|Reported Event|Induction Phase|Overall population in the Induction phase + safety follow-up period following induction phase.
514553|NCT00308581|E2|Reported Event|Q2W Regimen|Subjects who were randomized to and received Q2W regimen (every 2 weeks: 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
514554|NCT00308581|E1|Reported Event|Q4W Regimen|Subjects who were randomized to and received Q4W regimen (every 2 weeks: alternatively placebo and 400 mg Certolizumab Pegol); randomized maintenance phase + safety follow-up period following randomized maintenance phase.
514555|NCT00308555|B3|Baseline|Total|Total of all reporting groups
514556|NCT00308555|B2|Baseline|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for chronic pain
514557|NCT00308555|B1|Baseline|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain
514558|NCT00308555|P2|Participant Flow|Oxycontin|Patients using oxycodone hydrochloride (OxyContin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
514559|NCT00308555|P1|Participant Flow|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for chronic pain were administered vaporized cannabis (3.96% delta 9-THC) equivalent to one 0.9 g cigarette on the following schedule: 20:00 on Day 1, 08:00/14:00/20:00 on Days 2 through 4, and 08:00 on Day 5.
514560|NCT00308555|O2|Outcome|Oxycodone|Participants on oxycodone treatment
514561|NCT00308555|O1|Outcome|MS Contin|Participants on morphine treatment
514562|NCT00308555|E2|Reported Event|Oxycontin|Patients using oxycodone hydrochloride (OxyContin)every 12 hours for cancer pain
514563|NCT00308555|E1|Reported Event|MS Contin|Patients using morphine sulfate (MS Contin) every 12 hours for cancer pain
514564|NCT00308516|B3|Baseline|Total|Total of all reporting groups
514565|NCT00308516|B2|Baseline|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514597|NCT00308230|B3|Baseline|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
516769|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
514566|NCT00308516|B1|Baseline|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514567|NCT00308516|P2|Participant Flow|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514568|NCT00308516|P1|Participant Flow|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514569|NCT00308516|O2|Outcome|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514570|NCT00308516|O1|Outcome|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514571|NCT00308516|E2|Reported Event|Postoperative 5FU/Radiation/Bevacizumab|"All patients enrolled in cohort B received 5-fluorouracil (5-FU) 225 mg/m2 IVCI on days 1-42. Bevacizumab was administered at 5 mg/kg IV on day 1 every 2 weeks. These patients also received radiation to 50.4 Gy (1.8 Gy/day or 28 fractions)Monday through Friday during weeks 1-6.~Six weeks after the completion of adjuvant 5-FU/radiation, patients began treatment with 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514572|NCT00308516|E1|Reported Event|Preoperative 5FU/Radiation/Bevacizumab|"Each patient enrolled in the preoperative cohort received 5-fluorouracil (5-FU) 225 mg/m2 as a continuous infusion (IVCI) on days 1-42 through a portable infusion pump and central venous catheter. Bevacizumab 5 mg/kg was administered intravenously (IV) on days 1 and 15. Additionally these patients received radiation therapy to 50.4 Gy (1.8 Gy/day or 28 fractions) Monday through Friday during weeks 1-6.~At least 8 weeks after surgery, patients in cohort A began 4 months of chemotherapy and bevacizumab. This adjuvant treatment consisted of 5-FU 400 mg/m2 IV bolus over 2-4 minutes followed by 2400 mg/m2 IVCI over 46 hours, leucovorin 350 mg as a 2-hour infusion, oxaliplatin 85 mg/m2 IV (modified FOLFOX6) and bevacizumab 5 mg/kg IV all on days 1 and 15 of each cycle."
514573|NCT00308308|B3|Baseline|Total|Total of all reporting groups
514574|NCT00308308|B2|Baseline|Insulin Aspart + Insulin Glargine|Comparator
514575|NCT00308308|B1|Baseline|TI + Insulin Glargine|TI + Insulin glargine
514576|NCT00308308|P2|Participant Flow|Insulin Aspart + Insulin Glargine|Comparator
514577|NCT00308308|P1|Participant Flow|TI + Insulin Glargine|TI + Insulin glargine
514578|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514579|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514580|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514581|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514582|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514583|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514584|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514585|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514586|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514587|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514588|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514589|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514590|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514591|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514592|NCT00308308|O2|Outcome|Insulin Aspart + Insulin Glargine|Comparator
514593|NCT00308308|O1|Outcome|TI + Insulin Glargine|TI + Insulin glargine
514594|NCT00308308|E2|Reported Event|Insulin Aspart + Insulin Glargine|Comparator
514595|NCT00308308|E1|Reported Event|TI + Insulin Glargine|TI + Insulin glargine
514596|NCT00308230|B4|Baseline|Total|Total of all reporting groups
516770|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
514598|NCT00308230|B2|Baseline|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
514599|NCT00308230|B1|Baseline|Control|Structurally normal heart without heart disease
514600|NCT00308230|P3|Participant Flow|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
514601|NCT00308230|P2|Participant Flow|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
514602|NCT00308230|P1|Participant Flow|Control Group|Structurally normal heart without heart disease.
514603|NCT00308230|O3|Outcome|Heart Failure|Left ventricular failure
514604|NCT00308230|O2|Outcome|Congenital Heart Disease|TOF, DTGA, CCTGA-tetralogy of Fallot, the transposition of the great arteries, congenitally corrected transposition
514605|NCT00308230|O1|Outcome|Control Group|Structurally normal hearts
514606|NCT00308230|E3|Reported Event|Heart Failure|Acquired left ventricular heart failure, no history of congenital heart disease
514607|NCT00308230|E2|Reported Event|Congenital Heart Disease|Tetralogy of Fallot, d-transposition of the great arteries, congenitally corrected transposition of the great arteries
514608|NCT00308230|E1|Reported Event|Control Group|Structurally normal heart without heart disease
514609|NCT00308139|B3|Baseline|Total|Total of all reporting groups
514610|NCT00308139|B2|Baseline|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514611|NCT00308139|B1|Baseline|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514612|NCT00308139|P2|Participant Flow|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514613|NCT00308139|P1|Participant Flow|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514614|NCT00308139|O5|Outcome|Exenatide Once Weekly With Non-SU|Subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
514615|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364.
514616|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 31 to week 364
514617|NCT00308139|O2|Outcome|Exenatide Twice Daily With Non-SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) not using concomitant SU at screening. Week 0 to week 30.
514618|NCT00308139|O1|Outcome|Exenatide Once Weekly With Non-SU|Subjects subcutaneous injection of 2 mg exenatide, once a week not using concomitant SU at screening. Week 0 to week 30.
514619|NCT00308139|O5|Outcome|Exenatide Once Weekly With SU|Subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
514620|NCT00308139|O4|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364.
514621|NCT00308139|O3|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 31 to week 364
514622|NCT00308139|O2|Outcome|Exenatide Twice Daily With SU|Subjects with subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) using concomitant SU at screening. Week 0 to week 30.
514623|NCT00308139|O1|Outcome|Exenatide Once Weekly With SU|Subjects subcutaneous injection of 2 mg exenatide, once a week using concomitant SU at screening. Week 0 to week 30.
514624|NCT00308139|O3|Outcome|All Treatment|
514625|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514626|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514627|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514628|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514629|NCT00308139|O3|Outcome|All Treatment|
514630|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514631|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514632|NCT00308139|O3|Outcome|All Treatment|
514633|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514634|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514635|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514636|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514637|NCT00308139|O3|Outcome|All Treatment|
514638|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514639|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514640|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514641|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514642|NCT00308139|O3|Outcome|All Treatment|
514643|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once WeeklyEdit|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514644|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514645|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514646|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514647|NCT00308139|O3|Outcome|All Treatment|
514648|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514649|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514650|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514651|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514652|NCT00308139|O3|Outcome|All Treatment|
514653|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514654|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514655|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 week).
514656|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514657|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514658|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514659|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514660|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514661|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514662|NCT00308139|O3|Outcome|All Treatmeat|
514663|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514664|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514665|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514666|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514667|NCT00308139|O3|Outcome|All Treatment|
514668|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514669|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514670|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514671|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514672|NCT00308139|O3|Outcome|All Treatment|
514673|NCT00308139|O2|Outcome|Exenatide Twice Daily -> Exenatide Once Weekly|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514674|NCT00308139|O1|Outcome|Exenatide Once Weekly -> Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514675|NCT00308139|O2|Outcome|Exenatide Twice Daily|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514676|NCT00308139|O1|Outcome|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week.
514677|NCT00308139|E5|Reported Event|Exenatide Once Weekly|Subcutaneous injection of 2 mg exenatide, once a week. Pooling unique subjects from exenatide once weekly (WK 0-30), exenatide once weekly -> exenatide once weekly (WK 31-364), and exenatide twice daily -> exenatide once weekly (WK 31-364).
514678|NCT00308139|E4|Reported Event|Exenatide Twice Daily -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks) followed by 2 mg exenatide, once a week.
514679|NCT00308139|E3|Reported Event|Exenatide Once Weekly -> Exenatide Once Weekly (WK 31-364)|Subcutaneous injection of 2 mg exenatide, once a week.
514680|NCT00308139|E2|Reported Event|Exenatide Twice Daily (WK 0-30)|Subcutaneous injection of exenatide, twice a day (5 mcg exenatide per dose for first 4 weeks, then 10 mcg exenatide per dose for 26 weeks).
514681|NCT00308139|E1|Reported Event|Exenatide Once Weekly (WK 0-30)|Subcutaneous injection of 2 mg exenatide, once a week.
514682|NCT00308113|B5|Baseline|Total|Total of all reporting groups
514683|NCT00308113|B4|Baseline|Enhanced Standard of Care|Enhanced standard of care.
514684|NCT00308113|B3|Baseline|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514685|NCT00308113|B2|Baseline|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514686|NCT00308113|B1|Baseline|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514687|NCT00308113|P4|Participant Flow|Enhanced Standard of Care|Enhanced standard of care.
514688|NCT00308113|P3|Participant Flow|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514689|NCT00308113|P2|Participant Flow|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514690|NCT00308113|P1|Participant Flow|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514691|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
514692|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514693|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514694|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514695|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
514696|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514697|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514698|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514699|NCT00308113|O4|Outcome|Enhanced Standard of Care|Enhanced standard of care.
514700|NCT00308113|O3|Outcome|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514701|NCT00308113|O2|Outcome|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514702|NCT00308113|O1|Outcome|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514703|NCT00308113|E4|Reported Event|Enhanced Standard of Care|Enhanced standard of care.
514704|NCT00308113|E3|Reported Event|Coenzyme Q10 and Prednisone|"CoenzymeQ10 and prednisone each taken once a day in the morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL.~Prednisone : Prednisone 0/75 mg/kg/day."
514705|NCT00308113|E2|Reported Event|Prednisone Alone|"Prednisone taken once a day each morning by mouth~Prednisone : Prednisone 0/75 mg/kg/day."
514706|NCT00308113|E1|Reported Event|Coenzyme Q10 Alone|"CoenzymeQ10 taken once a day each morning by mouth.~Coenzyme Q10 : serum levels of greater or equal to 2.5 micrograms/mL."
514707|NCT00308087|B3|Baseline|Total|Total of all reporting groups
514708|NCT00308087|B2|Baseline|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514709|NCT00308087|B1|Baseline|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514710|NCT00308087|P2|Participant Flow|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514711|NCT00308087|P1|Participant Flow|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514712|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514713|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514714|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514715|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514716|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514717|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514718|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514719|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514763|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514873|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514874|NCT00307684|O2|Outcome|Placebo|matching placebo
514720|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514721|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514722|NCT00308087|O2|Outcome|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514723|NCT00308087|O1|Outcome|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514724|NCT00308087|E2|Reported Event|Rituximab + Sargramostim|Sargramostim 250 μg, administered subcutaneously (SC) 3 times weekly for 8 weeks, beginning at least 1 hour before the first dose of rituximab. Plus four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks.
514725|NCT00308087|E1|Reported Event|Rituximab|Four doses of rituximab 375 mg/m2, administered intravenously (IV) once weekly for 4 weeks
514726|NCT00308074|B1|Baseline|Aripiprazole|aripiprazole monotherapy
514727|NCT00308074|P1|Participant Flow|Aripiprazole|"aripiprazole monotherapy~Aripiprazole will be started at 2.5 or 5mg depending on clinical impression and severity of aggression and agitation. The dose will be evaluated weekly, according to clinical impression and adjusted if deemed appropriate, in not more than 5mg increments . The lowest effective dose will be used."
514728|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
514729|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
514730|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
514731|NCT00308074|O1|Outcome|Aripiprazole|aripiprazole monotherapy
514732|NCT00308074|E1|Reported Event|Aripiprazole|aripiprazole monotherapy
514733|NCT00307931|B1|Baseline|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514734|NCT00307931|P1|Participant Flow|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514735|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514736|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514737|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514738|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514739|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514740|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514741|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514742|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514743|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514744|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514745|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514746|NCT00307931|O1|Outcome|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514747|NCT00307931|E1|Reported Event|Certolizumab Pegol 400 mg|Certolizumab pegol 400 mg administered at Weeks 0, 2 ,4 ,8 and 12
514748|NCT00307801|B3|Baseline|Total|Total of all reporting groups
514749|NCT00307801|B2|Baseline|Placebo|Matching placebo to be taken orally daily.
514750|NCT00307801|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514751|NCT00307801|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
514752|NCT00307801|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514753|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
514754|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514755|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
514756|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514757|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514758|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514759|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514760|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514761|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514762|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514764|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514765|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514766|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514767|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514768|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514769|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514770|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514771|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514772|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514773|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514774|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514775|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514776|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514777|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514778|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514779|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514780|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514781|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514782|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514783|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514784|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514785|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514786|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514787|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514788|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514789|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514790|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514791|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514792|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514793|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514794|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514795|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514796|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514797|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514867|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514868|NCT00307684|O2|Outcome|Placebo|matching placebo
514798|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514799|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514800|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514801|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514802|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514803|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514804|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514805|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514806|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514807|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514808|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514809|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514810|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514811|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514812|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514813|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514814|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514815|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514816|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514817|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514818|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514819|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514820|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514821|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514822|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514823|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514824|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514825|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514826|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514827|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514828|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514829|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514830|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514831|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514869|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
514870|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514832|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514833|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514834|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514835|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514836|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514837|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514838|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514839|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514840|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514841|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514842|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514843|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514844|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514845|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514846|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514847|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514848|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514849|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514850|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514851|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514852|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514853|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514854|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514855|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514856|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514857|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily.
514858|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514859|NCT00307801|O2|Outcome|Placebo|Matching placebo to be taken orally daily
514860|NCT00307801|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514861|NCT00307801|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
514862|NCT00307801|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister consists of 28 tablets taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo.
514863|NCT00307684|B1|Baseline|Overall Study Population|Prolonged release (PR) Osmotic Release Oral Systems (OROS) MPH 18 to 90 mg once daily during the OL phase. Subjects who had received at 52 weeks of uninterrupted treatment with PR OROS MPH and provided consent for the DB phase were randomly assigned to placebo or their previous dose of PR OROS MPH (18 to 90 mg once daily)
514864|NCT00307684|P3|Participant Flow|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514865|NCT00307684|P2|Participant Flow|Placebo|matching placebo
514866|NCT00307684|P1|Participant Flow|Active|PR OROS MPH 18 to 90 mg once daily
514871|NCT00307684|O2|Outcome|Placebo|matching placebo
514876|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514877|NCT00307684|O2|Outcome|Placebo|matching placebo
514878|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
514879|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514880|NCT00307684|O2|Outcome|Placebo|matching placebo
514881|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
514882|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514883|NCT00307684|O2|Outcome|Placebo|matching placebo
514884|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
514885|NCT00307684|O3|Outcome|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514886|NCT00307684|O2|Outcome|Placebo|matching placebo
514887|NCT00307684|O1|Outcome|Active|PR OROS MPH 18 to 90 mg once daily
514888|NCT00307684|E3|Reported Event|Open Label PR OROS MPH|PR OROS MPH 18 to 90 mg once daily
514889|NCT00307684|E2|Reported Event|Placebo|matching placebo
514890|NCT00307684|E1|Reported Event|Active|PR OROS MPH 18 to 90 mg once daily
514891|NCT00307489|B3|Baseline|Total|Total of all reporting groups
514892|NCT00307489|B2|Baseline|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514893|NCT00307489|B1|Baseline|Tenofovir DF|tenofovir DF 300 mg QD
514894|NCT00307489|P2|Participant Flow|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514895|NCT00307489|P1|Participant Flow|Tenofovir DF|tenofovir DF 300 mg QD
514896|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514897|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514898|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514899|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514900|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514901|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514902|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514903|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514904|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514905|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514906|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514907|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514908|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514909|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514910|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514911|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514912|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514913|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514914|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514915|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514916|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514917|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514918|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514919|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514920|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514921|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514922|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514923|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514924|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514925|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514926|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514927|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514928|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514929|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514930|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514931|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514932|NCT00307489|O2|Outcome|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514933|NCT00307489|O1|Outcome|Tenofovir DF|tenofovir DF 300 mg QD
514934|NCT00307489|E2|Reported Event|Emtricitibine/Tenofovir DF|emtricitabine 200 mg / tenofovir DF 300 mg QD (combination tablet)
514935|NCT00307489|E1|Reported Event|Tenofovir DF|tenofovir DF 300 mg QD
514936|NCT00307437|B4|Baseline|Total|Total of all reporting groups
514937|NCT00307437|B3|Baseline|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
514938|NCT00307437|B2|Baseline|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
516771|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
514939|NCT00307437|B1|Baseline|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
514940|NCT00307437|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
514941|NCT00307437|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
514942|NCT00307437|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
514943|NCT00307437|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
514944|NCT00307437|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
514945|NCT00307437|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
514946|NCT00307437|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
514947|NCT00307437|O6|Outcome|Group 6: Combined (12 Week Dosing)|Combined Groups 2 and 4 (dosing every 12 weeks)
514948|NCT00307437|O5|Outcome|Group 5: Combined (8 Week Dosing)|Combined Groups 1 and 3 (dosing every 8 weeks)
514949|NCT00307437|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
514950|NCT00307437|O3|Outcome|Group 3: Ustekinumab 90 mg Every 8 Weeks|Participants received ustekinumab 90 mg at Weeks 0, 4, 16., 28, 36 and 44.
514951|NCT00307437|O2|Outcome|Group 2: Ustekinumab 45mg Every 12 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
514952|NCT00307437|O1|Outcome|Group 1: Ustekinumab 45mg Every 8 Weeks|Participants received ustekinumab 45 mg at Weeks 0, 4, 16, 28, 36 and 44.
514953|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Participants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
514954|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Participants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, participants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
514955|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
514956|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal to 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
514957|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
514958|NCT00307437|O1|Outcome|Group I: Placebo|Placebo partcipants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
514959|NCT00307437|O3|Outcome|Group III: Ustekinumab 90 mg|Partcipants received ustekinumab 90 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 90 mg every 12 week or dose adjust to 90 mg every 8 week dosing.
514960|NCT00307437|O2|Outcome|Group II: Ustekinumab 45 mg|Partcipants received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 28, partcipants who achieved a greater than and equal 50 percentage but less than 75 percentage improvement in PASI were re-randomized to continue 45 mg every 12 week or dose adjust to 45 mg every 8 week dosing.
514961|NCT00307437|O1|Outcome|Group I: Placebo|Placebo participants received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
514962|NCT00307437|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244.
514963|NCT00307437|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
514964|NCT00307437|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244.
514965|NCT00307437|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 12 to Week 244. Some patients in this group dose escalated from ustekinumab 45 mg to 90 mg after Week 52.
514966|NCT00307437|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
514967|NCT00307437|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
514968|NCT00307437|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
514969|NCT00307333|B3|Baseline|Total|Total of all reporting groups
514970|NCT00307333|B2|Baseline|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514971|NCT00307333|B1|Baseline|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514972|NCT00307333|P2|Participant Flow|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514973|NCT00307333|P1|Participant Flow|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514974|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514975|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514976|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514977|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514978|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514979|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514980|NCT00307333|O2|Outcome|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514981|NCT00307333|O1|Outcome|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514982|NCT00307333|E2|Reported Event|Control|Very low birth weight infants for whom the HRC index is not displayed. Infants receive standard of care treatment.
514983|NCT00307333|E1|Reported Event|Intervention|Very low birth weight infants with their HRC index continuously displayed. Clinicians can utilize the HRC score to develop treatment plan.
514984|NCT00307294|B1|Baseline|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
514985|NCT00307294|P1|Participant Flow|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
514986|NCT00307294|O1|Outcome|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
514987|NCT00307294|E1|Reported Event|Thalidomide and Doxil|"Combination of Thalidomide and Doxil~Thalidomide: 100 mg PO q day and escalation will occur bt 50 mg every 4 weeks to a maximum of 200mg~Doxil: On day 1 of each cycle 40 mg/m2 IV over 1 hr every 28 days"
514988|NCT00307164|B3|Baseline|Total|Total of all reporting groups
514989|NCT00307164|B2|Baseline|Placebo|Participants received NucleomaxX placebo through week 48
514990|NCT00307164|B1|Baseline|NucleomaxX|Participants received NucleomaxX for uridine through week 48
514991|NCT00307164|P2|Participant Flow|Placebo|Participants received NucleomaxX placebo through week 48
514992|NCT00307164|P1|Participant Flow|NucleomaxX|Participants received NucleomaxX for uridine through week 48
514993|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
514994|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
514995|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
514996|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
514997|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
514998|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
514999|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515000|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515001|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515002|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515003|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515004|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515005|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515006|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515007|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515008|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515009|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515010|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515011|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515012|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515013|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515014|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515015|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515016|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515017|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515018|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515019|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
516772|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
515020|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515021|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515022|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515023|NCT00307164|O2|Outcome|Placebo|Participants received NucleomaxX placebo through week 48
515024|NCT00307164|O1|Outcome|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515025|NCT00307164|E2|Reported Event|Placebo|Participants received NucleomaxX placebo through week 48
515026|NCT00307164|E1|Reported Event|NucleomaxX|Participants received NucleomaxX for uridine through week 48
515027|NCT00307151|B5|Baseline|Total|Total of all reporting groups
515028|NCT00307151|B4|Baseline|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515029|NCT00307151|B3|Baseline|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515030|NCT00307151|B2|Baseline|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515031|NCT00307151|B1|Baseline|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515032|NCT00307151|P4|Participant Flow|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515033|NCT00307151|P3|Participant Flow|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515034|NCT00307151|P2|Participant Flow|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515035|NCT00307151|P1|Participant Flow|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515036|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515037|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515038|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515039|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515040|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515041|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515042|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515043|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515044|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515045|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515046|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515047|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515048|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515049|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515050|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515051|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515052|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515053|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515054|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515055|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515056|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515057|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515058|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515059|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515060|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515061|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515062|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515063|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515064|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515065|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515066|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515067|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515068|NCT00307151|O4|Outcome|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen
515143|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515069|NCT00307151|O3|Outcome|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen
515070|NCT00307151|O2|Outcome|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515071|NCT00307151|O1|Outcome|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515072|NCT00307151|E4|Reported Event|Coh II: LPV/r|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive a PI-based regimen.
515073|NCT00307151|E3|Reported Event|Coh II: NVP|Cohort II: Did not previously receive SD NVP. Randomly assigned to receive an NNRTI-based regimen.
515074|NCT00307151|E2|Reported Event|Coh I: LPV/r|Cohort I: Previously received SD NVP. Randomly assigned to receive a PI-based regimen.
515075|NCT00307151|E1|Reported Event|Coh I: NVP|Cohort I: Previously received single dose nevirapine (SD NVP). Randomly assigned to receive an NNRTI-based regimen.
515076|NCT00307125|B3|Baseline|Total|Total of all reporting groups
515077|NCT00307125|B2|Baseline|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515078|NCT00307125|B1|Baseline|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515079|NCT00307125|P3|Participant Flow|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515080|NCT00307125|P2|Participant Flow|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515081|NCT00307125|P1|Participant Flow|Screening Phase|Kidney (renal) transplant recipients with no detectable anti-human leukocyte antigen (HLA) antibodies prior to transplant. Participants were screened for the development of anti-HLA antibodies once every 3 months up to 36 months post-transplantation and yearly thereafter until Month 60.
515082|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515083|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515084|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515085|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515086|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515087|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515088|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515089|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515090|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515091|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515092|NCT00307125|O2|Outcome|Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression is site-specific."
515093|NCT00307125|O1|Outcome|Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects ≤18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515094|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515095|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515096|NCT00307125|O2|Outcome|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515097|NCT00307125|O1|Outcome|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515098|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase of the study
515099|NCT00307125|O1|Outcome|Screening Phase|Participants who were analyzed during the screening phase/stage of the study
515100|NCT00307125|E2|Reported Event|Pilot Phase-Placebo Plus Immunosuppression|"Adult Dosing (Subjects >18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subject <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515101|NCT00307125|E1|Reported Event|Pilot Phase-Rituximab Plus Immunosuppression|"Adult Dosing (Subjects > 18 years): 1000 mg on days 0 and 14; Pediatric Dosing (Subjects <\=18 years): 375 mg/m^2/dose (maximum 500 mg/dose) in 4 doses, once per week (Days 0, 8, 15 and 22).~Standard immunosuppression was site-specific."
515102|NCT00307086|B1|Baseline|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
515103|NCT00307086|P1|Participant Flow|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
515104|NCT00307086|O1|Outcome|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
515105|NCT00307086|E1|Reported Event|Autologous PBSCT|"bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous peripheral blood stem cell transplant~Bortezomib : the maximum tolerated dose (MTD) of bortezomib in combination with high-dose melphalan as a conditioning regimen for autologous stem cell transplant~PBSCT : PBSCT #1 Day 0 PBSCT #2 Day 0 (approx 90 days =/- 15 days after PBSCT #1)~Melphalan : Day -4 melphalan 100 mg/m2 intravenously over 30 minutes, Day -3 melphalan 100 mg/m2 intravenously over 30 minutes"
515106|NCT00307047|B3|Baseline|Total|Total of all reporting groups
515107|NCT00307047|B2|Baseline|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515108|NCT00307047|B1|Baseline|XIENCE V®|Patients recieving the XIENCE V® stent
515109|NCT00307047|P2|Participant Flow|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515110|NCT00307047|P1|Participant Flow|XIENCE V®|Patients recieving the XIENCE V® stent
515111|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515112|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515113|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515114|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515115|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515116|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515117|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515118|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515119|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515120|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515121|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515122|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515123|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515124|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515125|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515126|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515127|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515128|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515129|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515130|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515131|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515132|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515133|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515134|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515135|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515136|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515137|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515138|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515139|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515140|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515141|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515142|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515144|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515145|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515146|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515147|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515148|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515149|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515150|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515151|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515152|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515153|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515154|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515155|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515156|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515157|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515158|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515159|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515160|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515161|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515162|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515163|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515164|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515165|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515166|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515167|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515168|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515169|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515170|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515171|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515172|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515173|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515174|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515175|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515176|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515177|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515178|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515179|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515180|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515181|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515182|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515183|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515184|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515185|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515186|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515187|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515188|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515189|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515190|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515191|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515192|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515193|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515194|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515195|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515196|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515197|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515198|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515199|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515200|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515201|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515202|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515203|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515204|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515205|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515206|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515207|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515208|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515209|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515210|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515211|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515212|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515213|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515214|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515215|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515216|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515217|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515218|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515219|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515220|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515221|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515222|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515223|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515224|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515225|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515226|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515227|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515228|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515229|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515230|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515231|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515232|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515233|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515234|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515235|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515236|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515237|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515238|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515239|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515240|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515241|NCT00307047|O2|Outcome|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515242|NCT00307047|O1|Outcome|XIENCE V®|Patients recieving the XIENCE V® stent
515243|NCT00307047|E2|Reported Event|TAXUS™ EXPRESS 2™|Patients receiving the TAXUS™ EXPRESS 2™ stent
515244|NCT00307047|E1|Reported Event|XIENCE V®|Patients recieving the XIENCE V® stent
515245|NCT00306917|B3|Baseline|Total|Total of all reporting groups
515246|NCT00306917|B2|Baseline|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515247|NCT00306917|B1|Baseline|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515248|NCT00306917|P2|Participant Flow|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515249|NCT00306917|P1|Participant Flow|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515250|NCT00306917|O2|Outcome|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515291|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515292|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515726|NCT00305565|B3|Baseline|High Dose|Received output current 1.0-1.5 mA
515251|NCT00306917|O1|Outcome|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515252|NCT00306917|E2|Reported Event|Porocoat Porous Coated|The Summit™ Porocoat® stems are primary, cementless hip implants that a feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The lower portion of the stems has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515253|NCT00306917|E1|Reported Event|DuoFix HA|The Summit™ DuoFix™ HA stems are primary, cementless hip implants. Summit™ cementless stems feature 3°-tapered body geometry to enhance fit, and are manufactured from forged titanium alloy. The Summit™ cementless stems are designed to load the femur toward the upper part of the stem, and therefore the Porocoat® porous coating is applied only to the upper body of the stem. The DuoFix™ HA stem also has a thin coating of hydroxyapatite on this porous-coated surface. This HA coating is only 35 microns thick, so the optimum pore size is maintained. The lower portion of the stem has a grit-blasted surface, which promotes bone on-growth and the polished bullet-tip prevents end-stem loading.
515254|NCT00306891|B5|Baseline|Total|Total of all reporting groups
515255|NCT00306891|B4|Baseline|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
515256|NCT00306891|B3|Baseline|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
515257|NCT00306891|B2|Baseline|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515258|NCT00306891|B1|Baseline|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515259|NCT00306891|P4|Participant Flow|Cediranib 30 to 90 mg Dose Escalation|Part B: Cediranib Dose Escalation
515260|NCT00306891|P3|Participant Flow|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
515261|NCT00306891|P2|Participant Flow|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515262|NCT00306891|P1|Participant Flow|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515263|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
515264|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
515265|NCT00306891|O2|Outcome|Arm 4 - Cediranib 30-90 mg Dose Escalation|Part B: Cediranib 30-90 mg Dose Escalation
515266|NCT00306891|O1|Outcome|Arm 3 - Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
515267|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515268|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515269|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515270|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515271|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515272|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515273|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515274|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515275|NCT00306891|O2|Outcome|Arm 2 - Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515276|NCT00306891|O1|Outcome|Arm 1 - Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515277|NCT00306891|O2|Outcome|Cediranib 45 mg Fasted|Part A: Cediranib 45 mg Fasted State
515278|NCT00306891|O1|Outcome|Cediranib 45 mg Fed|Part A: Cediranib 45 mg Fed State
515279|NCT00306891|E3|Reported Event|Cediranib 30 - 90 mg Dose Escalation|Cediranib 30 - 90 mg Dose Escalation
515280|NCT00306891|E2|Reported Event|Cediranib 45 mg Fixed Dose|Part B: Cediranib 45 mg Fixed Dose
515281|NCT00306891|E1|Reported Event|Cediranib 45 mg Part A|Part A: Cediranib 45 mg
515282|NCT00306852|B3|Baseline|Total|Total of all reporting groups
515283|NCT00306852|B2|Baseline|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515284|NCT00306852|B1|Baseline|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515285|NCT00306852|P2|Participant Flow|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515286|NCT00306852|P1|Participant Flow|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515287|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515288|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515289|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515290|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515293|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515294|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515295|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515296|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515297|NCT00306852|O2|Outcome|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515298|NCT00306852|O1|Outcome|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515299|NCT00306852|E2|Reported Event|Implant|"Baerveldt Implant~Baerveldt implant: Patients will be randomized to receive a 350 mm^2 Baerveldt glaucoma implant or a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes)"
515300|NCT00306852|E1|Reported Event|Trabeculectomy|"Trabeculectomy with mitomycin C~Trabeculectomy with mitomycin C: Patients will be randomized to receive either a Trabeculectomy (guarded filtration surgery) with mitomycin C (0.4 mg/ml for 4 minutes) or a 350 mm^2 Baerveldt glaucoma implant"
515301|NCT00306787|B3|Baseline|Total|Total of all reporting groups
515302|NCT00306787|B2|Baseline|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515303|NCT00306787|B1|Baseline|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515304|NCT00306787|P2|Participant Flow|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515305|NCT00306787|P1|Participant Flow|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515306|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515307|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515308|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515309|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515310|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515311|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515312|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515313|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515338|NCT00306527|B3|Baseline|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515314|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515315|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515316|NCT00306787|O2|Outcome|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515317|NCT00306787|O1|Outcome|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515318|NCT00306787|E2|Reported Event|Valacyclovir|Patients received Valacyclovir 500 mg capsule twice a day (b.i.d) approximately 12 hours apart for 3 consecutive days. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions. On the first day patients also received 2 famciclovir placebo tablets taken with the first 2 doses of Valacyclovir.
515319|NCT00306787|E1|Reported Event|Famciclovir|Patients received Famciclovir 1000 mg (2 x 500 mg tablets) twice a day for one day. The first dose was to be taken within 6 hours after onset of prodromal symptoms or genital herpes lesions and the second dose approximately 12 hours later. Patients also received 1 valacyclovir placebo capsule, beginning with the first famciclovir dose, twice a day for 3 days, each taken about 12 hours apart.
515320|NCT00306670|B3|Baseline|Total|Total of all reporting groups
515321|NCT00306670|B2|Baseline|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
515322|NCT00306670|B1|Baseline|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
515323|NCT00306670|P2|Participant Flow|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
515324|NCT00306670|P1|Participant Flow|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
515325|NCT00306670|O2|Outcome|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
515326|NCT00306670|O1|Outcome|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
515327|NCT00306670|E2|Reported Event|Oral Cyclophosphamide|"Patients will receive oral cyclophosphamide.~prednisone: <30 mg/day"
515328|NCT00306670|E1|Reported Event|Rituximab|"Patients will receive rituximab.~Rituxan: Acquired Hemophilia A Patients Who Have Developed Anti-Factor VIII Antibodies~prednisone: <30 mg/day"
515329|NCT00306592|B1|Baseline|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515330|NCT00306592|P2|Participant Flow|Natalizumab Study 101-MS-321 (NCT00297232)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 268 weeks. (Week 52 through Week 480 of Study 101-MS-321 (NCT00297232) is considered to be the Long-Term Treatment Period).
515331|NCT00306592|P1|Participant Flow|Natalizumab Study 101-MS-322 (NCT00306592)|Open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515332|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515333|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515334|NCT00306592|O1|Outcome|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515335|NCT00306592|E1|Reported Event|300 mg Natalizumab IV Monthly|All study participants in 101-MS-322 (NCT00306592) and 101-MS-321 (NCT00297232) received open label 300 mg intravenous (IV) natalizumab 60-minute infusion once every 4 weeks (28 days ±7 days) for up to 48 weeks. After 48 weeks, participants from 101-MS-322 (NCT00306592) entering study 101-MS-321 (NCT 00297232; considered the Long-Term Treatment Period of 101-MS-322) were continued on treatment from Week 52 through Week 480.
515336|NCT00306527|B5|Baseline|Total|Total of all reporting groups
515337|NCT00306527|B4|Baseline|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515339|NCT00306527|B2|Baseline|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
515340|NCT00306527|B1|Baseline|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine, received one dose of cTIV in this study, one year later.
515341|NCT00306527|P4|Participant Flow|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61years) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515342|NCT00306527|P3|Participant Flow|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61years of age ) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
515343|NCT00306527|P2|Participant Flow|Adults (cTIV\TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515344|NCT00306527|P1|Participant Flow|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
515345|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515346|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515347|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515348|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515349|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515350|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515351|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515352|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515353|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515354|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515355|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515356|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515357|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515358|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515359|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515360|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515361|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515362|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515363|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515364|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515365|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515366|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515367|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515628|NCT00306163|P1|Participant Flow|Ciclesonide|160 µg, once daily
515368|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515369|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515370|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515371|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515372|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515373|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515374|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515375|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515376|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515377|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515378|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515379|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515380|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515381|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515382|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515383|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515384|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515385|NCT00306527|O8|Outcome|TIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515386|NCT00306527|O7|Outcome|TIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515387|NCT00306527|O6|Outcome|TIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of cell-derived trivalent influenza (cTIV) one year later, in this study.
515388|NCT00306527|O5|Outcome|TIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with egg-derived influenza vaccine (TIV), received one dose of egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515389|NCT00306527|O4|Outcome|cTIV\TIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515390|NCT00306527|O3|Outcome|cTIV\cTIV (Elderly)|Subjects (≥61years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515391|NCT00306527|O2|Outcome|cTIV\TIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of an egg-derived trivalent influenza vaccine (TIV) one year later, in this study.
515392|NCT00306527|O1|Outcome|cTIV\cTIV (Adults)|Subjects (18-60 years of age) previously vaccinated with cell-derived influenza vaccine (cTIV), received one dose of cell-derived trivalent influenza vaccine (cTIV) one year later, in this study.
515393|NCT00306527|E4|Reported Event|Elderly (cTIV\TIV) + (TIV\TIV)|Subjects (≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515394|NCT00306527|E3|Reported Event|Elderly (cTIV\cTIV) + (TIV\cTIV)|Subjects(≥61 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
515395|NCT00306527|E2|Reported Event|Adults (cTIV/TIV) + (TIV\TIV)|Subjects (18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of TIV in this study, one year later.
515396|NCT00306527|E1|Reported Event|Adults (cTIV\cTIV) + (TIV\cTIV)|Subjects(18-60 years of age) who previously received one dose of either cell-derived (cTIV) or egg derived (TIV) trivalent influenza vaccine received one dose of cTIV in this study, one year later.
515397|NCT00306488|B1|Baseline|Participant Information|
515398|NCT00306488|P2|Participant Flow|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
515399|NCT00306488|P1|Participant Flow|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
515400|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
515401|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
515402|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
515403|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
515404|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
515405|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
515406|NCT00306488|O2|Outcome|Fellow Eye|The fellow eye was not treated with the study medication (OT-511 antioxidant eye drops).
515407|NCT00306488|O1|Outcome|Study Eye: OT-511 Antioxidant Eye Drop|The study eye was treated with one drop (40µL) of 0.45% OT-551 antioxidant eye drops three times a day.
515408|NCT00306488|E1|Reported Event|Participant Adverse Event Information|
515409|NCT00306384|B4|Baseline|Total|Total of all reporting groups
515410|NCT00306384|B3|Baseline|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515411|NCT00306384|B2|Baseline|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515412|NCT00306384|B1|Baseline|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515413|NCT00306384|P3|Participant Flow|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515414|NCT00306384|P2|Participant Flow|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515415|NCT00306384|P1|Participant Flow|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515416|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515417|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515418|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515419|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515420|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515421|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515422|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515423|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515424|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515425|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515426|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515427|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515428|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515429|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515430|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515431|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515432|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515433|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515434|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515435|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515436|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515437|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515629|NCT00306163|O2|Outcome|Fluticasone|100 µg, twice daily
515438|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515439|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515440|NCT00306384|O3|Outcome|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515441|NCT00306384|O2|Outcome|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515442|NCT00306384|O1|Outcome|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515443|NCT00306384|E3|Reported Event|Rescued: Alogliptin 25 mg|Participants rescued from the previous double-blind study received alogliptin 25 mg tablets, orally once daily for up to 4 years.
515444|NCT00306384|E2|Reported Event|Alogliptin 25 mg|Participants who completed the previous double-blind study received alogliptin 25 mg tablets orally, once daily for up to 4 years.
515445|NCT00306384|E1|Reported Event|Alogliptin 12.5 mg|Participants who completed the previous double-blind study received alogliptin 12.5 tablet, orally, once daily for up to 4 years.
515446|NCT00306202|B4|Baseline|Total|Total of all reporting groups
515447|NCT00306202|B3|Baseline|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515448|NCT00306202|B2|Baseline|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515449|NCT00306202|B1|Baseline|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515450|NCT00306202|P3|Participant Flow|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515451|NCT00306202|P2|Participant Flow|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515452|NCT00306202|P1|Participant Flow|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515453|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515454|NCT00306202|O1|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515455|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515456|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515457|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515458|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515459|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515460|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515630|NCT00306163|O1|Outcome|Ciclesonide|160 µg, once daily
515631|NCT00306163|E2|Reported Event|Fluticasone|100 µg, twice daily
515461|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515462|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515463|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515464|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515465|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515466|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515467|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515468|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515469|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515470|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515471|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515472|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515473|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515474|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515475|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515476|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515477|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515478|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515479|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515480|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515481|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515482|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515483|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515632|NCT00306163|E1|Reported Event|Ciclesonide|160 µg, once daily
515484|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515485|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515486|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515487|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515488|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515489|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515490|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515491|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515492|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515493|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515494|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515495|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515496|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515497|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515498|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515499|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515500|NCT00306202|O4|Outcome|Dasatinib 120 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained."
515501|NCT00306202|O3|Outcome|Dasatinib 100 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained."
515502|NCT00306202|O2|Outcome|Dasatinib 80 mg/m^2|"Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515503|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2|Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515504|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
515505|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
515506|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
515507|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Tablets, Oral; If necessary in participants who could not swallow, tablets were dispersed into 30 cc of 100% fruit juice with no preservatives (minute maid lemonade or orange juice or apple juice).~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
515508|NCT00306202|O1|Outcome|Dasatinib 60 mg/m^2 QD Starting Dose|"Stratum 1 (Ph+ CP-CML): Participants with imatinib-resistant Ph+ CML in CP; Stratum 2/3 (PH+ ALL OR AP/BP-CML): Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in AP, or in MBP, or in LBP; or relapsed or refractory Ph+ ALL after imatinib use; or second or subsequent relapse of Ph+ AML; Stratum 4 (PH- ALL/AML): Participants with second or subsequent relapse of Ph- ALL or Ph- AML.~Strata 1, 2/3, and 4: 60 mg/m^2 starting dose; 80 mg/m^2 escalated/dose level 2; Stratum 4: 100 mg/m^2 escalated/dose level 3 and 120 mg/m^2 escalated/dose level 4. QD, as long as clinical benefit was observed."
515509|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515510|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515511|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515512|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2.~QD, as long as clinical benefit was maintained."
515513|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515514|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515515|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515516|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515517|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515518|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515519|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515520|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515521|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515522|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515523|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515524|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
515525|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
515526|NCT00306202|O1|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2 QD, as long as clinical benefit was maintained."
515527|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515528|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515529|NCT00306202|O2|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515530|NCT00306202|O1|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515531|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515532|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515533|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515534|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515535|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515536|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515537|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515538|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515539|NCT00306202|O4|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515540|NCT00306202|O3|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515541|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515542|NCT00306202|O1|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515543|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515544|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515727|NCT00305565|B2|Baseline|Medium Dose|Received output current 0.5-1.0 mA
515545|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515546|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 1 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515547|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515548|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515549|NCT00306202|O2|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515550|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515551|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515552|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515553|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515554|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515555|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515556|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515557|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515558|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515559|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Ph+ chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515560|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515561|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515562|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515563|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515564|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515565|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515728|NCT00305565|B1|Baseline|Low Dose|Received output current 0.25 mA
515729|NCT00305565|P3|Participant Flow|High Dose|Received output current 1.0-1.5 mA
515566|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515567|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
515568|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515569|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515570|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515571|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515572|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515573|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515574|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515575|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2, as long as clinical benefit was maintained."
515576|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515577|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515578|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515579|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515580|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515581|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515582|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515583|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515584|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515585|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515586|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515587|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515588|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515589|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515633|NCT00305942|B1|Baseline|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515590|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515591|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515592|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515593|NCT00306202|O8|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 120 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 120 mg/m^2 QD, as long as clinical benefit was maintained.
515594|NCT00306202|O7|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 100 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 100 mg/m^2 QD, as long as clinical benefit was maintained.
515595|NCT00306202|O6|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 80 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained.
515596|NCT00306202|O5|Outcome|Stratum 4 Ph- ALL/AML (Dasatinib 60 mg/m^2)|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained.
515597|NCT00306202|O4|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515598|NCT00306202|O3|Outcome|Stratum 2/3 Ph+ ALL or AP/BP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515599|NCT00306202|O2|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 80 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 80 mg/m^2 QD, as long as clinical benefit was maintained."
515600|NCT00306202|O1|Outcome|Stratum 1 Ph+ CP-CML (Dasatinib 60 mg/m^2)|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Dasatinib 60 mg/m^2 QD, as long as clinical benefit was maintained."
515601|NCT00306202|O3|Outcome|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2, escalated/dose level 3 of 100 mg/m^2, escalated/dose level 3 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515602|NCT00306202|O2|Outcome|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515603|NCT00306202|O1|Outcome|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515604|NCT00306202|E3|Reported Event|Stratum4 Ph- ALL/AML; Dasatinib 60 mg/m^2 Starting Dose|Participants with second or subsequent relapse of Ph- ALL or Ph- AML. Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2, Escalated/Dose level 3 of 100 mg/m^2, and Escalated/Dose level 4 of 120 mg/m^2. QD, as long as clinical benefit was maintained.
515605|NCT00306202|E2|Reported Event|Stratum2/3 Ph+ALL or AP/BP-CML;Dasatinib60mg/m^2 Starting Dose|"Participants with imatinib-resistant or imatinib-intolerant Ph+ CML in accelerated phase (AP), or in myeloid blast phase (MBP), or in lymphoid blast phase (LBP); or relapsed or refractory Ph+ acute lymphoblastic leukemia (ALL) after imatinib use; or second or subsequent relapse of Ph+ acute myeloid leukemia (AML).~Starting Dose Level of 60 mg/m^2; Escalated/Dose level 2 of 80 mg/m^2. QD, as long as clinical benefit was maintained."
515606|NCT00306202|E1|Reported Event|Stratum1 Ph+ CP-CML; Dasatinib 60 mg/m^2 Starting Dose|"Participants with imatinib-resistant Philadelphia chromosome positive (Ph+) chronic myeloid leukemia (CML) in chronic phase (CP).~Starting Dose Level of 60 mg/m^2; Escalated/Dose Level 2 of 80 mg/m^2. Once daily (QD), as long as clinical benefit was maintained."
515607|NCT00306189|B5|Baseline|Total|Total of all reporting groups
515608|NCT00306189|B4|Baseline|Placebo|
515609|NCT00306189|B3|Baseline|Denosumab 100 mg Q6M|
515610|NCT00306189|B2|Baseline|Denosumab 60 mg Q6M|
515611|NCT00306189|B1|Baseline|Denosumab 14 mg Q6M|
515612|NCT00306189|P4|Participant Flow|Placebo|
515613|NCT00306189|P3|Participant Flow|Denosumab 100 mg Q6M|
515614|NCT00306189|P2|Participant Flow|Denosumab 60 mg Q6M|
515615|NCT00306189|P1|Participant Flow|Denosumab 14 mg Q6M|
515616|NCT00306189|O4|Outcome|Denosumab 100 mg Q6M|
515617|NCT00306189|O3|Outcome|Denosumab 60 mg Q6M|
515618|NCT00306189|O2|Outcome|Denosumab 14 mg Q6M|
515619|NCT00306189|O1|Outcome|Placebo|
515620|NCT00306189|E4|Reported Event|Denosumab 100 mg Q6M|
515621|NCT00306189|E3|Reported Event|Denosumab 60 mg Q6M|
515622|NCT00306189|E2|Reported Event|Denosumab 14 mg Q6M|
515623|NCT00306189|E1|Reported Event|Placebo|
515624|NCT00306163|B3|Baseline|Total|Total of all reporting groups
515625|NCT00306163|B2|Baseline|Fluticasone|100 µg, twice daily
515626|NCT00306163|B1|Baseline|Ciclesonide|160 µg, once daily
515627|NCT00306163|P2|Participant Flow|Fluticasone|100 µg, twice daily
515634|NCT00305942|P1|Participant Flow|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515635|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515636|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515637|NCT00305942|O1|Outcome|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515638|NCT00305942|E1|Reported Event|Topotecan/Carboplatin|Topotecan 4mg/m2 IV on days 1, 8. Carboplatin AUC=5 IV day 1 only . - Cycles are repeated every 21 days for > 4 cycles of topotecan and carboplatin (maximum 6 courses). Restaging studies will be performed every 2 cycles (or 6 weeks.)
515639|NCT00305877|B3|Baseline|Total|Total of all reporting groups
515640|NCT00305877|B2|Baseline|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515641|NCT00305877|B1|Baseline|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515642|NCT00305877|P2|Participant Flow|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515643|NCT00305877|P1|Participant Flow|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515644|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515645|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515646|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515647|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515648|NCT00305877|O2|Outcome|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515649|NCT00305877|O1|Outcome|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515650|NCT00305877|E2|Reported Event|Arm B (Bevacizumab, Gemcitabine, Capecitabine, Radiation)|Patients receive bevacizumab IV over 60-90 minutes on day 1 every other week for 24 weeks. Patients also receive gemcitabine hydrochloride and capecitabine and undergo radiotherapy as in Arm A.
515651|NCT00305877|E1|Reported Event|Arm A (Cetuximab, Gemcitabine, Capecitabine, Radiation)|Patients receive cetuximab IV over 60-120 minutes on day 1, once weekly, in weeks 1-24; gemcitabine hydrochloride IV over 30 minutes on day 1, once weekly, in weeks 1-3, 13-15, 17-19, and 21-23; oral capecitabine twice daily on days 1-5, 5 days a week, in weeks 5-10. Patients also undergo radiotherapy once daily, 5 days a week, beginning in week 5 and continuing for approximately 5½ weeks (25 fractions).
515652|NCT00305864|B5|Baseline|Total|Total of all reporting groups
515653|NCT00305864|B4|Baseline|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515685|NCT00305773|E1|Reported Event|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515686|NCT00305760|B1|Baseline|Group 1|
515687|NCT00305760|P1|Participant Flow|Group 1|
515654|NCT00305864|B3|Baseline|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515655|NCT00305864|B2|Baseline|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515656|NCT00305864|B1|Baseline|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515657|NCT00305864|P4|Participant Flow|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515658|NCT00305864|P3|Participant Flow|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515659|NCT00305864|P2|Participant Flow|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515660|NCT00305864|P1|Participant Flow|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515661|NCT00305864|O1|Outcome|All MGd 5mg/kg Patients (Phase I and II Arms Combined)|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515662|NCT00305864|O3|Outcome|Phase I: 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515663|NCT00305864|O2|Outcome|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515688|NCT00305760|O1|Outcome|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|
515730|NCT00305565|P2|Participant Flow|Medium Dose|Received output current 0.5-1.0 mA
515731|NCT00305565|P1|Participant Flow|Low Dose|Received output current 0.25 milliamps (mA)
515732|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515664|NCT00305864|O1|Outcome|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515665|NCT00305864|E4|Reported Event|Phase II: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515666|NCT00305864|E3|Reported Event|Phase I: MGd 5 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515667|NCT00305864|E2|Reported Event|Phase I: MGd 4 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515668|NCT00305864|E1|Reported Event|Phase I: MGd 3 mg/kg|Patients undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, and 36-40. Beginning the night before the first dose of radiotherapy and ending the night before the last dose of radiotherapy, patients receive concurrent oral temozolomide once daily on days 0-39. Patients also receive MGd IV over 30 minutes prior to radiotherapy once daily on days 1-5 and 8-12 and then on days 15, 17, 19, 22, 24, 26, 29, 31, 33, 36, 38, and 40. Beginning 28 days after the completion of radiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.
515669|NCT00305773|B3|Baseline|Total|Total of all reporting groups
515670|NCT00305773|B2|Baseline|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515671|NCT00305773|B1|Baseline|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515672|NCT00305773|P2|Participant Flow|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515673|NCT00305773|P1|Participant Flow|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515674|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515675|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515676|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515677|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515678|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515679|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515680|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515681|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515682|NCT00305773|O2|Outcome|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515683|NCT00305773|O1|Outcome|Arm A (Once Daily Vorinostat)|Patients receive oral vorinostat (SAHA) once a day on days 1-21. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515684|NCT00305773|E2|Reported Event|Arm B (Thrice Daily Vorinostat)|Patients receive oral SAHA three times a day on days 1-14. Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
515812|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515689|NCT00305760|E1|Reported Event|Cyclophosphamide, Pancreatic Tumor Vaccine, Cetuximab|"Cetuximab: Cetuximab will be administered at an initial dose of 400 mg/m2, followed by weekly doses of 250 mg/m2 for a total of 6 cycles that last 3 weeks each.~Pancreatic tumor vaccine: Vaccine will be administered one day after cyclophosphamide (day 1) every three weeks for 6 cycles.~Cyclophosphamide: Cyclophosphamide 250 mg/m2 will be administered one day prior to vaccination (day 0) every three weeks for 6 cycles."
515690|NCT00305643|B3|Baseline|Total|Total of all reporting groups
515691|NCT00305643|B2|Baseline|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515692|NCT00305643|B1|Baseline|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515693|NCT00305643|P2|Participant Flow|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515694|NCT00305643|P1|Participant Flow|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515695|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard Capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515696|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515697|NCT00305643|O2|Outcome|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515698|NCT00305643|O1|Outcome|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515699|NCT00305643|E2|Reported Event|Arm II: Placebo + Capecitabine|Arm II: Placebo with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515700|NCT00305643|E1|Reported Event|Arm I: Celecoxib + Capecitabine|Arm I: Celecoxib 200 mg given orally twice/day along with standard capecitabine treatment (Initial dose of 750-1500 mg/m^2 orally twice/day).
515701|NCT00305604|B3|Baseline|Total|Total of all reporting groups
515702|NCT00305604|B2|Baseline|Placebo|Sitagliptin-matching placebo tablets.
515703|NCT00305604|B1|Baseline|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515704|NCT00305604|P2|Participant Flow|Placebo|Sitagliptin-matching placebo tablets.
515705|NCT00305604|P1|Participant Flow|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515706|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
515707|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515708|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
515709|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515710|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
515711|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515712|NCT00305604|O2|Outcome|Placebo|Sitagliptin-matching placebo tablets.
515713|NCT00305604|O1|Outcome|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515714|NCT00305604|E2|Reported Event|Placebo|Sitagliptin-matching placebo tablets.
515715|NCT00305604|E1|Reported Event|Sitagliptin|Once-daily administration of sitagliptin 100 mg (or 50 mg based on creatinine clearance); Patients may be down-titrated (1 instead of 2 tablets) if there is a decrease in creatinine clearance to < 50 mL/min at any time during the study.
515716|NCT00305578|B3|Baseline|Total|Total of all reporting groups
515717|NCT00305578|B2|Baseline|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
515718|NCT00305578|B1|Baseline|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
515719|NCT00305578|P2|Participant Flow|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
515720|NCT00305578|P1|Participant Flow|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
515721|NCT00305578|O2|Outcome|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
515722|NCT00305578|O1|Outcome|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
515723|NCT00305578|E2|Reported Event|Memantine|"Daily dose Memantine~Memantine : Memantine will be given orally. Subjects will be started at a dose of 5 mg for the first week and then increased by 5 mg every week up to a maximum of 20 mg depending on response and tolerance and will be kept at that level for the rest of the study. This is an 8 week study."
515724|NCT00305578|E1|Reported Event|Placebo|"Placebo daily~Placebo : No active medication, only placebo"
515725|NCT00305565|B4|Baseline|Total|Total of all reporting groups
515733|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515734|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515735|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515736|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515737|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515738|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515739|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515740|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515741|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515742|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515743|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515744|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515745|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515746|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515747|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515748|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515749|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515750|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515751|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515752|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515753|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515754|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515755|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515756|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515757|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515758|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515759|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515760|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515761|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515762|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515763|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515764|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515765|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515766|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515767|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515768|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515769|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515770|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515771|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515772|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515773|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515774|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515775|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515776|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515777|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
515778|NCT00305565|O1|Outcome|Log Dose-Response Regression Coefficient|All dosing groups
515779|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515780|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515781|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515782|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515783|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515784|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515785|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515786|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515787|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515788|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515789|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515790|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515791|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515792|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515793|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515794|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515795|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515796|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515797|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515798|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515799|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515800|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515801|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515802|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515803|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515804|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515805|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515806|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515807|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515808|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515809|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515810|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515811|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515813|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515814|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515815|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515816|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515817|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515818|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515819|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515820|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515821|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515822|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515823|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515824|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515825|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515826|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515827|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515828|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515829|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515830|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515831|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515832|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515833|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515834|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515835|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515836|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515837|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515838|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515839|NCT00305565|O3|Outcome|High Dose|Received output current 1.0-1.5 mA
515840|NCT00305565|O2|Outcome|Medium Dose|Received output current 0.5-1.0 mA
515841|NCT00305565|O1|Outcome|Low Dose|Received output current 0.25 mA
515842|NCT00305565|E3|Reported Event|High Dose|Received output current 1.0-1.5 mA
515843|NCT00305565|E2|Reported Event|Medium Dose|Received output current 0.5-1.0 mA
515844|NCT00305565|E1|Reported Event|Low Dose|Received output current 0.25 mA
515845|NCT00305448|B4|Baseline|Total|Total of all reporting groups
515846|NCT00305448|B3|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
515847|NCT00305448|B2|Baseline|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515848|NCT00305448|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg
515849|NCT00305448|P3|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
515850|NCT00305448|P2|Participant Flow|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515851|NCT00305448|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg
515852|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
515853|NCT00305448|O1|Outcome|Fulvestrant|Fulvestrant
515854|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
515855|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515856|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
515857|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
515858|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515859|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
515860|NCT00305448|O3|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
515861|NCT00305448|O2|Outcome|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515862|NCT00305448|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg
515863|NCT00305448|E3|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
515864|NCT00305448|E2|Reported Event|Fulvestrant 250 mg + Loading Dose|Fulvestrant 250 mg + Loading Dose
515865|NCT00305448|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg
515866|NCT00305344|B1|Baseline|Cord Blood Recipient|Umbilical Cord Recipient
515867|NCT00305344|P1|Participant Flow|Cord Blood Recipient|Umbilical Cord Recipient
515868|NCT00305344|O1|Outcome|Recipients Receiving Cord Blood|Children with type 1 diabetes who underwent an autologous cord blood infusion
515869|NCT00305344|E1|Reported Event|Cord Blood Recipients|Children with type 1 diabetes who underwent an autologous cord blood infusion
515870|NCT00305253|B3|Baseline|Total|Total of all reporting groups
515871|NCT00305253|B2|Baseline|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
515872|NCT00305253|B1|Baseline|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
515873|NCT00305253|P2|Participant Flow|Post-Intervention|Post-intervention (NASG) period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol plus NASG.
515874|NCT00305253|P1|Participant Flow|Pre-Intervention|Pre-intervention period: patients experiencing obstetric hemorrhage were treated with standardized evidence-based protocol.
515875|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
515876|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
515877|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
515878|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
515879|NCT00305253|O2|Outcome|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
515972|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
515880|NCT00305253|O1|Outcome|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
515881|NCT00305253|E2|Reported Event|Post-Intervention|facilities will treat patients with standardized evidence-based protocol plus NASG when a patient meets the study criteria.
515882|NCT00305253|E1|Reported Event|Pre-Intervention|facilities will treat patients with standardized evidence-based protocol when a patient meets the study criteria.
515883|NCT00305227|B3|Baseline|Total|Total of all reporting groups
515884|NCT00305227|B2|Baseline|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515885|NCT00305227|B1|Baseline|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515886|NCT00305227|P2|Participant Flow|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515887|NCT00305227|P1|Participant Flow|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515888|NCT00305227|O2|Outcome|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515889|NCT00305227|O1|Outcome|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515890|NCT00305227|E2|Reported Event|Placebo|Vaginal capsule - placebo. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515891|NCT00305227|E1|Reported Event|Lactin-V|Vaginal capsule containing Lactobacillus crispatus in high concentration. Self-administered once daily for 5 days during the 1st week. Self-administered once weekly for 10 weeks.
515892|NCT00305162|B3|Baseline|Total|Total of all reporting groups
515893|NCT00305162|B2|Baseline|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515894|NCT00305162|B1|Baseline|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
515895|NCT00305162|P2|Participant Flow|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion followed by placebo capsules post infusion
515896|NCT00305162|P1|Participant Flow|Cangrelor Arm|cangrelor arm: placebo capsules at PCI start + cangrelor bolus(30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
515897|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515898|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515899|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515900|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515901|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515902|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515903|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515904|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515905|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515906|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515907|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515908|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515909|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515910|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515911|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515973|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
515974|NCT00304746|O2|Outcome|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
515912|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515913|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515914|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515915|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515916|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515917|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515918|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515919|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515920|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515921|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515922|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515923|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515924|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515925|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515926|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515927|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg) at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515928|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515929|NCT00305162|O2|Outcome|Clopidogrel Arm|clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515930|NCT00305162|O1|Outcome|Cangrelor Arm|placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4 mcg/kg/min) administered from randomization for at least 2 hours, or until the end of the PCI, whichever is longer with the option to extend up to 4 hours maximum (per investigator discretion) + active clopidogrel (600mg) post infusion
515931|NCT00305162|E2|Reported Event|Clopidogrel Arm|clopidogrel arm: clopidogrel capsules (600 mg)at PCI start + placebo bolus & infusion (to match) followed by placebo capsules post infusion
515932|NCT00305162|E1|Reported Event|Cangrelor Arm|cangrelor arm: placebo capsules (to match) at PCI start + cangrelor bolus (30 mcg/kg) & infusion (4mcg/kg/min) followed by clopidogrel (600 mg) post infusion
515933|NCT00304954|B5|Baseline|Total|Total of all reporting groups
515934|NCT00304954|B4|Baseline|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
515935|NCT00304954|B3|Baseline|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
515936|NCT00304954|B2|Baseline|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
515937|NCT00304954|B1|Baseline|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
515938|NCT00304954|P4|Participant Flow|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
515939|NCT00304954|P3|Participant Flow|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
515940|NCT00304954|P2|Participant Flow|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
516773|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
515941|NCT00304954|P1|Participant Flow|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
515942|NCT00304954|O4|Outcome|Sixth-Month OCT - Fellow Eye|
515943|NCT00304954|O3|Outcome|Baseline OCT - Fellow Eye|
515944|NCT00304954|O2|Outcome|Sixth-Month OCT - Study Eye|
515945|NCT00304954|O1|Outcome|Baseline OCT - Study Eye|
515946|NCT00304954|O4|Outcome|Sixth-Month Vision - Fellow Eye|
515947|NCT00304954|O3|Outcome|Baseline Vision - Fellow Eye|
515948|NCT00304954|O2|Outcome|Sixth-Month Vision - Study Eye|
515949|NCT00304954|O1|Outcome|Baseline Vision - Study Eye|
515950|NCT00304954|O4|Outcome|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
515951|NCT00304954|O3|Outcome|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
515952|NCT00304954|O2|Outcome|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
515953|NCT00304954|O1|Outcome|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
515954|NCT00304954|E4|Reported Event|Observation|Participants randomly assigned to the observation group were given injections of either bevacizumab (1.25 mg/0.05 mL or 2.5 mg/0.1 mL) or ranibizumab (0.5 mg) if they presented with recurrence of intraretinal or subretinal fluid as seen on Stratus Optical Coherence Tomography.
515955|NCT00304954|E3|Reported Event|Oral Rapamycin|Participants randomly assigned to rapamycin received 2 mg in capsule form every other day for 6 months.
515956|NCT00304954|E2|Reported Event|Intravenous Infliximab|Participants randomized to IV infliximab received 3 mg/kg of IV infliximab monthly for 6 months.
515957|NCT00304954|E1|Reported Event|Intravenous Daclizumab|Participants randomly assigned to intravenous (IV) daclizumab received 8 mg/kg of IV daclizumab at baseline, then 4 mg/kg of IV daclizumab at Week 2 and then 2 mg/kg of IV daclizumab monthly for the rest of the 6-month study.
515958|NCT00304915|B3|Baseline|Total|Total of all reporting groups
515959|NCT00304915|B2|Baseline|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
515960|NCT00304915|B1|Baseline|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
515961|NCT00304915|P2|Participant Flow|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same 9-item Patient Health Questionnaire (PHQ-9) screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
515962|NCT00304915|P1|Participant Flow|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in VA electronic medical record. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
515963|NCT00304915|O2|Outcome|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
515964|NCT00304915|O1|Outcome|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
515965|NCT00304915|E2|Reported Event|Arm 2: Usual Care|Usual care arm. Usual care will include depression screening with the same PHQ-9 screener used for Arm 1. The HI-TIDES depression care team will not be a part of the usual care condition.
515966|NCT00304915|E1|Reported Event|Arm 1: Collaborative Care Intervention|Collaborative Care Intervention: Patients in the intervention group will be supported by a depression collaborative care team that will include a depression nurse care manager, clinical pharmacist, and psychiatrist. The depression nurse care manager will evaluate depression symptom severity, antidepressant side effects, depression and HIV medication adherence every two weeks over the phone during the acute phase of treatment and will record these results in CPRS. After a 50% improvement in depression severity, the intervention subject will move into the continuation phase of treatment and the patient will be contacted every four weeks by the depression nurse case manager.
515967|NCT00304746|B3|Baseline|Total|Total of all reporting groups
515968|NCT00304746|B2|Baseline|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
515969|NCT00304746|B1|Baseline|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
515970|NCT00304746|P2|Participant Flow|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
515971|NCT00304746|P1|Participant Flow|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
515975|NCT00304746|O1|Outcome|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
515976|NCT00304746|E2|Reported Event|Placebo Gel|Placebo gel identical in appearance to the testosterone gel
515977|NCT00304746|E1|Reported Event|Testosterone Gel|AndroGel, (1% testosterone transdermal gel), 2.5 g - 10 g daily
515978|NCT00304265|B3|Baseline|Total|Total of all reporting groups
515979|NCT00304265|B2|Baseline|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
515980|NCT00304265|B1|Baseline|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
515981|NCT00304265|P2|Participant Flow|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
515982|NCT00304265|P1|Participant Flow|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
515983|NCT00304265|O2|Outcome|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
515984|NCT00304265|O1|Outcome|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
515985|NCT00304265|E2|Reported Event|5th Dose Pertussis Vaccine Group|Participants who had received at least 3 doses of whole-cell pertussis vaccine during infant immunization and at least 1 subsequent booster vaccination in the 2nd to 7th years of life received either REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 5th (booster) dose as adolescents.
515986|NCT00304265|E1|Reported Event|6th Dose Pertussis Vaccine Group|Participants who had received 5 doses of BIKEN acellular pertussis vaccine in Study 371-03/01 received REPEVAX® (Tdap-IPV: combination diphtheria, tetanus and acellular pertussis with inactivated poliomyelitis vaccine) or COVAXIS® (Tdap: combination diphtheria, tetanus and acellular pertussis) vaccine as a 6th (booster) dose as adolescents.
515987|NCT00304187|B3|Baseline|Total|Total of all reporting groups
515988|NCT00304187|B2|Baseline|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
515989|NCT00304187|B1|Baseline|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
515990|NCT00304187|P2|Participant Flow|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
515991|NCT00304187|P1|Participant Flow|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
515992|NCT00304187|O2|Outcome|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
515993|NCT00304187|O1|Outcome|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
515994|NCT00304187|E2|Reported Event|Placebo|"Participants will take matched placebo.~Placebo : Placebo, 250 mg or 500 mg, three times a day for 6 weeks"
515995|NCT00304187|E1|Reported Event|Erythromycin|"Subjects with Bulimia Nervosa will take erythromycin.~Erythromycin : Erythromycin, 250 mg or 500 mg, three times a day for 6 weeks"
515996|NCT00304161|B3|Baseline|Total|Total of all reporting groups
515997|NCT00304161|B2|Baseline|Placebo|Participants will receive placebo treatment
515998|NCT00304161|B1|Baseline|Atomoxetine|Participants will receive atomoxetine treatment
515999|NCT00304161|P2|Participant Flow|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
516000|NCT00304161|P1|Participant Flow|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
516001|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
516002|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
516003|NCT00304161|O2|Outcome|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
516004|NCT00304161|O1|Outcome|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
516005|NCT00304161|E2|Reported Event|Placebo|Participants will receive placebo treatment once daily; the pill (taken orally) will resemble the atomoxetine pill but will not contain an active drug.
516006|NCT00304161|E1|Reported Event|Atomoxetine|Participants will receive 40-80mgs of atomoxetine orally once daily.
516007|NCT00304096|B3|Baseline|Total|Total of all reporting groups
516008|NCT00304096|B2|Baseline|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
516009|NCT00304096|B1|Baseline|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
516010|NCT00304096|P2|Participant Flow|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
516011|NCT00304096|P1|Participant Flow|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
516012|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
516013|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
516014|NCT00304096|O2|Outcome|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
516015|NCT00304096|O1|Outcome|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
516016|NCT00304096|E2|Reported Event|Stratum 2: Had Not Received Hormonal Therapy|Participants had not received hormonal therapy
516017|NCT00304096|E1|Reported Event|Stratum 1: Received Hormonal Therapy|Participants received hormonal therapy
516018|NCT00304031|B4|Baseline|Total|Total of all reporting groups
516019|NCT00304031|B3|Baseline|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
516020|NCT00304031|B2|Baseline|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
516021|NCT00304031|B1|Baseline|No Adjuvant TMZ (Not Randomized )|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
516022|NCT00304031|P3|Participant Flow|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
516023|NCT00304031|P2|Participant Flow|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
516024|NCT00304031|P1|Participant Flow|No Adjuvant TMZ (Not Randomized)|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.
516025|NCT00304031|O2|Outcome|Dose-dense Adjuvant TMZ|Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.
516026|NCT00304031|O1|Outcome|Conventional Adjuvant TMZ|Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.
516027|NCT00304031|E3|Reported Event|Dose-dense Adjuvant TMZ|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~75mg/m2 adjuvant temozolomide days 1-21 of 28 day cycle: Oral temozolomide on days 1-21 of a 28-day cycle. Dose starts at 75mg/m2 for first cycle, increases to 100mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
516028|NCT00304031|E2|Reported Event|Conventional Adjuvant TMZ|"Concurrent radiation therapy with concurrent temozolomide (75 mg/m2) up to 49 doses. Starting four weeks after completion of RT, 100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions~100mg/m2 adjuvant temozolomide days 1 to 5 of 28 day cycle: Oral temozolomide on days 1-5 of a 28-day cycle. Dose starts at 150mg/m2 for first cycle, increases to 200mg/m2 for subsequent cycles if no unacceptable toxicity. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients with responding disease may receive up to 6 more courses of temozolomide."
516029|NCT00304031|E1|Reported Event|No Adjuvant TMZ (Not Randomized)|"Concurrent radiation therapy (RT) with concurrent temozolomide (75 mg/m2) up to 49 doses. Not randomized to either adjuvant TMZ arm.~Concurrent temozolomide: Daily oral temozolomide (75 mg/m2) up to 49 doses.~Concurrent radiation therapy: 60 Gy in 2 Gy fractions"
516030|NCT00303979|B4|Baseline|Total|Total of all reporting groups
516031|NCT00303979|B3|Baseline|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516032|NCT00303979|B2|Baseline|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516033|NCT00303979|B1|Baseline|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
516034|NCT00303979|P3|Participant Flow|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516035|NCT00303979|P2|Participant Flow|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516036|NCT00303979|P1|Participant Flow|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
516037|NCT00303979|O1|Outcome|Cohort C (18 Month)|The number of sites in Cohort C.
516038|NCT00303979|O1|Outcome|Cohort B (6 Month)|Number of sites in Cohort B (6 Month).
516039|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
516040|NCT00303979|O1|Outcome|Corhort A (Longitudinal)|The number of sites in Cohort A.
516041|NCT00303979|O1|Outcome|Cohort A (Longitudinal)|"For this longitudinal cohort, data are collected at baseline, 12 months and 24 months after the principle investigator and HF nurse attend an educational workshop. All longitudinal analyses will be performed on this cohort of patients. There will be two analysis sets from this cohort:~All Patients: All patients with baseline data Completers: Patients who have a qualifying visit at both baseline and 24 months who were living at the 24 month chart review and are qualified for at least one performance measure at 24 months."
516042|NCT00303979|E3|Reported Event|Cohort C (18 Month)|"18 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516043|NCT00303979|E2|Reported Event|Cohort B (6 Month)|"6 Month Cohort: Approximately 10,000 patients reviewed at single time point~Evidence based guidelines and tools : Education, guidelines, tools"
516044|NCT00303979|E1|Reported Event|Cohort A (Longitudinal)|"Longitudinal Cohort: Approximately 15,000 patients followed at baseline, 12 months and 24 months~Evidence based guidelines and tools : Education, guidelines, tools"
516045|NCT00303966|B1|Baseline|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516046|NCT00303966|P1|Participant Flow|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516047|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516048|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516049|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516050|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516051|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516052|NCT00303966|O1|Outcome|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516053|NCT00303966|E1|Reported Event|Treatment (Sorafenib Tosylate)|Patients receive oral sorafenib twice daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
516054|NCT00303953|B1|Baseline|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516055|NCT00303953|P1|Participant Flow|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516056|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516057|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516058|NCT00303953|O1|Outcome|PXD101|Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516059|NCT00303953|E1|Reported Event|PXD101|Only eligible patients were included in the analyses. Patients receive 1000 mg/m^2 IV PXD101 on days 1-5 of each 21-day cycle until disease progression.
516060|NCT00303901|B1|Baseline|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
516061|NCT00303901|P1|Participant Flow|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
516062|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
516063|NCT00303901|O1|Outcome|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
516064|NCT00303901|E1|Reported Event|Cryosurgery|"cryoprobe is placed in the proper position using CT imaging guidance, and as internal tissue is being frozen, the physician avoids damaging healthy tissue by viewing the movement of the probe on CT images transmitted to a monitor similar to a television screen. Living tissue, healthy or diseased, cannot withstand extremely cold conditions.~cryosurgery~positron emission tomography"
516065|NCT00303862|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516066|NCT00303862|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516067|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516068|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516069|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516070|NCT00303862|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516308|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516071|NCT00303862|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 4 weeks. Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity.
516072|NCT00303823|B3|Baseline|Total|Total of all reporting groups
516073|NCT00303823|B2|Baseline|Placebo|
516074|NCT00303823|B1|Baseline|Polyphenon E|
516075|NCT00303823|P2|Participant Flow|Placebo|Patients receive oral placebo once daily for 16 weeks
516076|NCT00303823|P1|Participant Flow|Polyphenon E (Defined Green Tea Catechin Extract)|Patients receive oral Polyphenon E daily for 16 weeks
516077|NCT00303823|O2|Outcome|Placebo|
516078|NCT00303823|O1|Outcome|Polyphenon E|
516079|NCT00303823|O2|Outcome|Placebo|
516080|NCT00303823|O1|Outcome|Polyphenon E|
516081|NCT00303823|O2|Outcome|Placebo|
516082|NCT00303823|O1|Outcome|Polyphenon E|
516083|NCT00303823|O2|Outcome|Placebo|
516084|NCT00303823|O1|Outcome|Polyphenon E|
516085|NCT00303823|E2|Reported Event|Placebo|
516086|NCT00303823|E1|Reported Event|Polyphenon E|
516087|NCT00303667|B3|Baseline|Total|Total of all reporting groups
516088|NCT00303667|B2|Baseline|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516089|NCT00303667|B1|Baseline|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516090|NCT00303667|P2|Participant Flow|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516091|NCT00303667|P1|Participant Flow|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516092|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516093|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516094|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516095|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516096|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516097|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516098|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516099|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516100|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516101|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516102|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516309|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516103|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516104|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516105|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516106|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516107|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516108|NCT00303667|O2|Outcome|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516109|NCT00303667|O1|Outcome|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516110|NCT00303667|E2|Reported Event|SCT w/Donor Natural Killer Cells - Short Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 40mg/m^2), cyclophosphamide (administered on Day -15 only), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516111|NCT00303667|E1|Reported Event|SCT w/Donor Natural Killer Cells - Extended Schema|Patients with high risk myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation, receiving fludarabine phosphate (daily dose of 35mg/m^2), cyclophosphamide (administered on Days -15 and -16), cyclosporin A, total body irradiation, natural killer cells, aldesleukin, and thymoglobulin.
516112|NCT00303628|B3|Baseline|Total|Total of all reporting groups
516113|NCT00303628|B2|Baseline|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516114|NCT00303628|B1|Baseline|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516115|NCT00303628|P2|Participant Flow|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516116|NCT00303628|P1|Participant Flow|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516117|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516118|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516119|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516120|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516121|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516122|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516153|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516123|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516124|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516125|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516126|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516127|NCT00303628|O2|Outcome|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV~bevacizumab: Given IV"
516128|NCT00303628|O1|Outcome|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses.~oxaliplatin: Given IV~fluorouracil: Given IV~leucovorin calcium: Given IV"
516129|NCT00303628|E2|Reported Event|Arm II (Oxaliplatin, Fluorouracil, Leucovorin, Bevacizumab)|Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive oxaliplatin, leucovorin calcium, and fluorouracil as in arm I
516130|NCT00303628|E1|Reported Event|Arm I (Oxaliplatin, Fluorouracil, Leucovorin)|Patients receive oxaliplatin intravenously (IV) over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV on day 1 followed by fluorouracil IV continuously over 46 hours on days 1 and 2. Treatment repeats every 2 weeks for up to 12 courses* in the absence of disease progression or unacceptable toxicity.
516131|NCT00303602|B3|Baseline|Total|Total of all reporting groups
516132|NCT00303602|B2|Baseline|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516133|NCT00303602|B1|Baseline|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516134|NCT00303602|P2|Participant Flow|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516135|NCT00303602|P1|Participant Flow|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516136|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516137|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516138|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516139|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516140|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516141|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516142|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516143|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516144|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516145|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516146|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516147|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516148|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516149|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516150|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516151|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516152|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516305|NCT00303446|B1|Baseline|Placebo|Matched placebo, one tablet daily
516154|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516155|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516156|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516157|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516158|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516159|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516160|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516161|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516162|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516163|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516164|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516165|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516166|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516167|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516168|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516169|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516170|NCT00303602|O2|Outcome|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516171|NCT00303602|O1|Outcome|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516172|NCT00303602|E2|Reported Event|SOT|Standard oral olanzapine tablet; 5 to 20 mg dose, supplied in 5 mg tablet strength, oral administration (tablets swallowed), daily for 16 weeks
516173|NCT00303602|E1|Reported Event|SODO|Sublingual orally disintegrating olanzapine (SODO); 5 to 20 mg dose, supplied in 5 mg tablet strength, tablet should be placed under tongue for at least 60 seconds, daily for 16 weeks
516174|NCT00303511|B1|Baseline|ACHD With Pacemaker|
516175|NCT00303511|P1|Participant Flow|ACHD With Pacemaker|
516176|NCT00303511|O1|Outcome|Cohort|
516177|NCT00303511|E1|Reported Event|ACHD With Pacemaker|
516178|NCT00303485|B3|Baseline|Total|Total of all reporting groups
516179|NCT00303485|B2|Baseline|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516180|NCT00303485|B1|Baseline|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516181|NCT00303485|P2|Participant Flow|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516182|NCT00303485|P1|Participant Flow|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516183|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516184|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516185|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516186|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516187|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516188|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516306|NCT00303446|P2|Participant Flow|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516189|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516190|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516191|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516192|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516193|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516194|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516195|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516196|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516197|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516198|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516199|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516200|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516201|NCT00303485|O2|Outcome|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516202|NCT00303485|O1|Outcome|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516203|NCT00303485|E2|Reported Event|Placebo|Participants received a matching placebo tablet to Ibandronate once-monthly along with a combination dietary supplement containing vitamin D 200 IU and elemental calcium 500 mg twice daily with meals for 6 months.
516204|NCT00303485|E1|Reported Event|Ibandronate|Participants received Ibandronate 150 mg tablet once-monthly along with a combination dietary supplement containing vitamin D 200 international units (IU) and elemental calcium 500 mg twice daily with meals for 6 months.
516205|NCT00303472|B8|Baseline|Total|Total of all reporting groups
516206|NCT00303472|B7|Baseline|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516207|NCT00303472|B6|Baseline|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516208|NCT00303472|B5|Baseline|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516209|NCT00303472|B4|Baseline|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516210|NCT00303472|B3|Baseline|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516211|NCT00303472|B2|Baseline|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516212|NCT00303472|B1|Baseline|Part A: 300 µg Romiplostim|Cohort 1 in Part A, participants received romiplostim 300 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516213|NCT00303472|P7|Participant Flow|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516214|NCT00303472|P6|Participant Flow|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516215|NCT00303472|P5|Participant Flow|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516216|NCT00303472|P4|Participant Flow|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516217|NCT00303472|P3|Participant Flow|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516218|NCT00303472|P2|Participant Flow|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516219|NCT00303472|P1|Participant Flow|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516220|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516221|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516222|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516223|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516224|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516225|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516226|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516227|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516228|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516229|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516230|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516231|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516232|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516233|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516234|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516235|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516236|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516237|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516238|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516239|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516240|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516241|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516242|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516243|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516244|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516245|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516246|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516247|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516248|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516249|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516250|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516251|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516252|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516253|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516254|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516255|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516256|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516257|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516258|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516259|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516260|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516261|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516262|NCT00303472|O3|Outcome|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516263|NCT00303472|O2|Outcome|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516307|NCT00303446|P1|Participant Flow|Placebo|Matched placebo, one tablet daily
516264|NCT00303472|O1|Outcome|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516265|NCT00303472|O4|Outcome|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516266|NCT00303472|O3|Outcome|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516267|NCT00303472|O2|Outcome|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516268|NCT00303472|O1|Outcome|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516269|NCT00303472|E7|Reported Event|Part B: 750 µg Romiplostim IV Q2W|Part B participants received romiplostim 750 µg intravenously (IV) once every two weeks for 8 weeks. Participants who completed Part B could continue to receive romiplostim for up to 1 year in the extension treatment phase.
516270|NCT00303472|E6|Reported Event|Part B: 750 µg Romiplostim SC Q2W|Part B participants received romiplostim 750 µg subcutaneously every two weeks (Q2W) for 8 weeks. Participants who completed Part B could continue to receive injections of romiplostim for up to 1 year in the extension treatment phase.
516271|NCT00303472|E5|Reported Event|Part B: 750 µg Romiplostim SC QW|Part B participants received romiplostim 750 µg subcutaneously (SC) once weekly (QW) for 8 weeks. Participants who completed Part B could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516272|NCT00303472|E4|Reported Event|Part A: 1500 µg Romiplostim|Cohort 4 in Part A, participants received romiplostim 1500 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516273|NCT00303472|E3|Reported Event|Part A: 1000 µg Romiplostim|Cohort 3 in Part A, participants received romiplostim 1000 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516274|NCT00303472|E2|Reported Event|Part A: 700 µg Romiplostim|Cohort 2 in Part A, participants received romiplostim 700 µg subcutaneously once weekly for up to 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516275|NCT00303472|E1|Reported Event|Part A: 300 µg Romiplostim|Cohort 1 in Part A participants received romiplostim 300 µg subcutaneously once weekly for 3 weeks. Participants who completed Part A could continue to receive weekly injections of romiplostim for up to 1 year in the extension treatment phase.
516276|NCT00303459|B3|Baseline|Total|Total of all reporting groups
516277|NCT00303459|B2|Baseline|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516278|NCT00303459|B1|Baseline|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516279|NCT00303459|P2|Participant Flow|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516280|NCT00303459|P1|Participant Flow|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, twice a day (b.i.d.) for 4 weeks then bosentan/125 mg tablet/b.i.d."
516281|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516282|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516283|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516284|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516285|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516286|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516287|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516288|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516289|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516290|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet, b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516291|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516292|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516293|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516294|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516295|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516296|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516297|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516298|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516299|NCT00303459|O2|Outcome|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516300|NCT00303459|O1|Outcome|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516301|NCT00303459|E2|Reported Event|Placebo|"Placebo~placebo: Matching bosentan placebo/b.i.d."
516302|NCT00303459|E1|Reported Event|Bosentan|"Bosentan~bosentan: bosentan/62.5 mg tablet/b.i.d. for 4 weeks then bosentan/125 mg tablet/b.i.d."
516303|NCT00303446|B3|Baseline|Total|Total of all reporting groups
516304|NCT00303446|B2|Baseline|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516310|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516311|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516312|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516313|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516314|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516315|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516316|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516317|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516318|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516319|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516320|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516321|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516322|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516323|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516324|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516325|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516326|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516327|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516328|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516329|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516330|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516331|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516332|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516333|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516334|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516335|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516336|NCT00303446|O2|Outcome|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516337|NCT00303446|O1|Outcome|Placebo|Matched placebo, one tablet daily
516338|NCT00303446|E2|Reported Event|Dutasteride|Dutasteride 500 micrograms, one tablet daily.
516339|NCT00303446|E1|Reported Event|Placebo|Matched placebo, one tablet daily
516340|NCT00303329|B3|Baseline|Total|Total of all reporting groups
516341|NCT00303329|B2|Baseline|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516342|NCT00303329|B1|Baseline|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516343|NCT00303329|P2|Participant Flow|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516344|NCT00303329|P1|Participant Flow|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516345|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516346|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516347|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516348|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516349|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516350|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516351|NCT00303329|O2|Outcome|Rare Anemias Patients|Deferasirox (5-40 mg/kg/day)
516352|NCT00303329|O1|Outcome|β-thalassemia Patients|Deferasirox (5-40 mg/kg/day)
516353|NCT00303329|E2|Reported Event|Rare Anemias|Deferasirox (5-40 mg/kg/day)
516354|NCT00303329|E1|Reported Event|Beta-thalassemia|Deferasirox (5-40 mg/kg/day)
516355|NCT00303316|B3|Baseline|Total|Total of all reporting groups
516356|NCT00303316|B2|Baseline|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516357|NCT00303316|B1|Baseline|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516358|NCT00303316|P2|Participant Flow|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516359|NCT00303316|P1|Participant Flow|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516360|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516361|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516362|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516407|NCT00303108|P1|Participant Flow|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516363|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516364|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516365|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516366|NCT00303316|O2|Outcome|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516367|NCT00303316|O1|Outcome|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516368|NCT00303316|E2|Reported Event|PENTAXIM™ and ENGERIX B® Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of PENTAXIM™ and ENGERIX B® PEDIATRICO (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516369|NCT00303316|E1|Reported Event|DTacP-IPV-Hep B-PRP~T Group|Participants received a booster dose of PENTAXIM™ at 18 months of age in this study. They had received 3 primary-series doses of Diphtheria (D), Tetanus (T), Pertussis (acellular component [aP]), hepatitis B (Hep B [recombinant DNA]) and poliomyelitis (Inactivated [IPV]), and Haemophilus influenzae type b (Hib) conjugated vaccine adsorbed (DTaP-IPV-HepB-PRP~T), (1 dose each at 2, 4, and 6 months of age) in Study A3L02 (NCT00831311).
516370|NCT00303186|B1|Baseline|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516371|NCT00303186|P1|Participant Flow|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516372|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516373|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516374|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516375|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516376|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516377|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516378|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516379|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516380|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516381|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516408|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
516409|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516410|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516382|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516383|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516384|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516385|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516386|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516387|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516388|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516389|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516390|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516391|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516392|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516393|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516394|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516395|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516396|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516397|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516398|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516399|NCT00303186|O1|Outcome|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516400|NCT00303186|E1|Reported Event|All Participants|Participants with psoriatic arthritis (PsA) prescribed with tumor necrosis factor (TNF) inhibitors (etanercept, infliximab, adalimumab) for the treatment of refractory PsA to the conventional treatments according to the Italian recommendations of Italian Society of Rheumatology were observed for 60 months.
516401|NCT00303108|B4|Baseline|Total|Total of all reporting groups
516402|NCT00303108|B3|Baseline|D+C+H|Doxil, Carboplatin, and Herceptin
516403|NCT00303108|B2|Baseline|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516404|NCT00303108|B1|Baseline|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516405|NCT00303108|P3|Participant Flow|D+C+H|Doxil, Carboplatin, and Herceptin
516406|NCT00303108|P2|Participant Flow|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516411|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
516412|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516413|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516414|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
516415|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516416|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516417|NCT00303108|O3|Outcome|D+C+H|Doxil, Carboplatin, and Herceptin
516418|NCT00303108|O2|Outcome|D+C and Taxane Pretreated|Doxil, Carboplatin and Taxane pretreated
516419|NCT00303108|O1|Outcome|D+C and Taxane Naive|Doxil, Carboplatin and Taxane naive
516420|NCT00303108|E2|Reported Event|D+C+H|Doxil, Carboplatin, and Herceptin
516421|NCT00303108|E1|Reported Event|D+C and Taxane Naive or Pretreated|Doxil, Carboplatin and Taxane naive or pretreated.
516422|NCT00303069|B5|Baseline|Total|Total of all reporting groups
516423|NCT00303069|B4|Baseline|Placebo|Saline placebo single dose at baseline.
516424|NCT00303069|B3|Baseline|V710 90 μg|V710 90 μg single dose at baseline.
516425|NCT00303069|B2|Baseline|V710 30 μg|V710 30 μg single dose at baseline.
516426|NCT00303069|B1|Baseline|V710 5 μg|V710 5 μg single dose at baseline.
516427|NCT00303069|P4|Participant Flow|Placebo|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
516428|NCT00303069|P3|Participant Flow|V710 90 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
516429|NCT00303069|P2|Participant Flow|V710 30 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
516430|NCT00303069|P1|Participant Flow|V710 5 μg|"Panel A (dose-ranging) consisted of 36 subjects divided into 3 sequential enrollment periods (Periods 1, 2, and 3), which evaluated the safety of V710 Staphylococcus aureus vaccine at incremental dosages (5 μg, 30 μg, and 90 μg). Subjects in each period were randomized at a 3:1 ratio to receive a single intramuscular (IM) injection of either V710 (5 μg at Period 1; 30 μg in Period 2; and 90 μg in Period 3).~Following the completion of Panel A and satisfactory interim review of the immunogenicity and safety data, the open-enrollment phase (Panel B) was initiated. Panel B consisted of 88 subjects randomized in a 1:1:1:1 ratio to receive a single IM injection of 1 of the 3 V710 dosages (5 μg, 30 μg, or 90 μg) or saline placebo. Enrollment in Panel B was stratified by age, with half of the subjects 18 to 39 years of age, the other half 40 to 55 years of age."
516431|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
516432|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
516433|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
516434|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
516435|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
516436|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
516437|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
516438|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
516439|NCT00303069|O4|Outcome|Placebo|Saline placebo single dose at baseline.
516440|NCT00303069|O3|Outcome|V710 90 μg|V710 90 μg single dose at baseline.
516441|NCT00303069|O2|Outcome|V710 30 μg|V710 30 μg single dose at baseline.
516442|NCT00303069|O1|Outcome|V710 5 μg|V710 5 μg single dose at baseline.
516443|NCT00303069|E4|Reported Event|Placebo|Saline placebo single dose at baseline.
516444|NCT00303069|E3|Reported Event|V710 90 μg|V710 90 μg single dose at baseline.
516445|NCT00303069|E2|Reported Event|V710 30 μg|V710 30 μg single dose at baseline.
516446|NCT00303069|E1|Reported Event|V710 5 μg|V710 5 μg single dose at baseline.
516447|NCT00302952|B3|Baseline|Total|Total of all reporting groups
516448|NCT00302952|B2|Baseline|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516569|NCT00302211|P2|Participant Flow|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
516774|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
516449|NCT00302952|B1|Baseline|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516450|NCT00302952|P2|Participant Flow|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516451|NCT00302952|P1|Participant Flow|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516452|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516453|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516454|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516455|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516456|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516457|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516458|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516459|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516460|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516461|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516462|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516463|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516464|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516570|NCT00302211|P1|Participant Flow|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
516465|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516466|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516467|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516468|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516469|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516470|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516471|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516472|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516473|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516474|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516475|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516476|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516477|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516478|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516479|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516480|NCT00302952|O2|Outcome|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516571|NCT00302211|O5|Outcome|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516775|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
516481|NCT00302952|O1|Outcome|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516482|NCT00302952|E2|Reported Event|Placebo|Participants were randomized to take two placebo tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. For toxicity, the dose could either be adjusted to one placebo tablet or treatment could be discontinued. The placebo tablets contained microcrystalline cellulose, NF (Avicel PH 102) and Supro AA Swedish Orange Opaque Capsule Shells, Color 4188.
516483|NCT00302952|E1|Reported Event|Lovastatin 80 mg|Participants were randomized to take two 40 mg lovastatin tablets orally once daily for a total of 12 weeks in a blinded (masked) fashion. In addition to the active ingredient lovastatin, each tablet contained the following ingredients: microcrystalline cellulose, lactose monohydrate, magnesium stearate, and pregelatinized starch. Butylated hydroxyanisole (BHA) was added as a preservative and D&C Yellow #10, FD&C Blue #1, and Yellow #6 were added as dyes.
516484|NCT00302848|B4|Baseline|Total|Total of all reporting groups
516485|NCT00302848|B3|Baseline|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
516486|NCT00302848|B2|Baseline|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
516487|NCT00302848|B1|Baseline|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
516488|NCT00302848|P3|Participant Flow|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
516489|NCT00302848|P2|Participant Flow|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
516490|NCT00302848|P1|Participant Flow|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
516491|NCT00302848|O2|Outcome|Users of LNG|Women who use authorized oral contraceptives containing LNG prescribed by their gynecologist
516492|NCT00302848|O1|Outcome|Users of DRSP|Women who use authorized oral contraceptives containing DRSP prescribed by their gynecologist
516493|NCT00302848|E3|Reported Event|Users of Other Oral Contraceptives (OCs)|Women who use oral contraceptives (OCs) containing other progestins
516494|NCT00302848|E2|Reported Event|Users of Levonorgestrel (LNG)|Women who use oral contraceptives (OCs) containing LNG as progestin
516495|NCT00302848|E1|Reported Event|Users of Drospirenone (DRSP)|Women who use oral contraceptives (OCs) containing DRSP as progestin
516496|NCT00302718|B5|Baseline|Total|Total of all reporting groups
516497|NCT00302718|B4|Baseline|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516498|NCT00302718|B3|Baseline|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516499|NCT00302718|B2|Baseline|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516500|NCT00302718|B1|Baseline|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516501|NCT00302718|P4|Participant Flow|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516502|NCT00302718|P3|Participant Flow|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516503|NCT00302718|P2|Participant Flow|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516504|NCT00302718|P1|Participant Flow|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516505|NCT00302718|O2|Outcome|Intervention Group|This group is a combination of the physician and non-physician participants and the patients on the panels of the physician participants from the three intervention arms: physician-level, practice-level, and physician- and practice-level financial incentives.
516506|NCT00302718|O1|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516507|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516572|NCT00302211|O4|Outcome|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516573|NCT00302211|O3|Outcome|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
516508|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516509|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516510|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516511|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516512|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516513|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516514|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516515|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516516|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516517|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516518|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516519|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516520|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516521|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516522|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516523|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516524|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516525|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516526|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516527|NCT00302718|O4|Outcome|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516528|NCT00302718|O3|Outcome|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516529|NCT00302718|O2|Outcome|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516530|NCT00302718|O1|Outcome|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516531|NCT00302718|E4|Reported Event|No Incentives (Control)|Physician participants in the control group did not receive any financial incentives. They received audit and feedback performance reports at the end of each performance period like the intervention groups.
516532|NCT00302718|E3|Reported Event|Physician- and Practice-level Incentives|"Examines the effect of physician and practice-level financial incentives on hypertension quality of care~Physician- and practice-level financial incentives: Enrolled subjects were eligible to receive financial incentives based on performance during a 4-month interval on the hypertension care study outcomes. This arm tested the effect of combined financial incentives."
516533|NCT00302718|E2|Reported Event|Practice-level Incentives|"Examines the effect of practice-level financial incentives on hypertension quality of care~Practice-level financial incentives: Enrolled practices (physician participants and non-physician primary care personnel) were eligible to receive financial incentives based on the performance of the practice during a 4-month interval on the hypertension care study outcomes."
516534|NCT00302718|E1|Reported Event|Physician-level Incentives|"Examines the effect of physician-level financial incentives on hypertension quality of care~Physician-level financial incentives: Enrolled physician participants were eligible to receive financial incentives based on their performance during a 4-month interval on the hypertension care study outcomes."
516535|NCT00302458|B1|Baseline|Healthy Volunteers|Healthy volunteers each received IR-MPH, OROS-MPH, and matched placebo (in four separate visits) in a four way crossover design.
516536|NCT00302458|P1|Participant Flow|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
516537|NCT00302458|O5|Outcome|OROS-MPH+ IR-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
516538|NCT00302458|O4|Outcome|OROS-MPH+OROS-MPH|Healthy volunteers received a dose of OROS-Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
516539|NCT00302458|O3|Outcome|IR-MPH +IR-MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of Immediate Release Methylphenidate four hours later
516540|NCT00302458|O2|Outcome|IR-MPH + OROS MPH|Healthy volunteers received a dose of Immediatate Release Methylphenidate at hour 0, followed by a dose of OROS-Methylphenidate four hours later
516541|NCT00302458|O1|Outcome|Placebo- Placebo|Healthy volunteers received a placebo, followed by a placebo four hours later
516542|NCT00302458|E1|Reported Event|Healthy Volunteers|Healthy volunteers each received IR MPH, Oros MPH, and matched placebo (at four separate study visits) in a four way crossover design.
516543|NCT00302328|B4|Baseline|Total|Total of all reporting groups
516544|NCT00302328|B3|Baseline|tb Peeling|trypan blue (tb) peeling
516545|NCT00302328|B2|Baseline|ICG Peeling|indocyanine green (ICG) peeling
516546|NCT00302328|B1|Baseline|no Peeling|no peeling used
516547|NCT00302328|P3|Participant Flow|tb Peeling|trypan blue (tb) peeling
516548|NCT00302328|P2|Participant Flow|ICG Peeling|indocyanine (ICG) peeling
516549|NCT00302328|P1|Participant Flow|no Peeling|no peeling used
516550|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
516551|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
516552|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
516553|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assited ilm peeling
516554|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg assited ilm peeling
516555|NCT00302328|O1|Outcome|no Peeling|vitrectomy without ilm peeling
516556|NCT00302328|O3|Outcome|tb Peeling|vitrectomy with trypan blue assisted ilm peeling
516557|NCT00302328|O2|Outcome|ICG Peeling|vitrectomy with icg-assisted ilm peeling
516558|NCT00302328|O1|Outcome|no Peeling|Vitrectomy without peeling
516559|NCT00302328|E3|Reported Event|tb Peeling|vitrectomy with trypan blue assited ilm peeling
516560|NCT00302328|E2|Reported Event|ICG Peeling|vitrectomy with icg assited ilm peeling
516561|NCT00302328|E1|Reported Event|no Peeling|vitrectomy without ilm peeling
516562|NCT00302211|B4|Baseline|Total|Total of all reporting groups
516563|NCT00302211|B3|Baseline|Placebo 6×/Day + Sildenafil +/- Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
516564|NCT00302211|B2|Baseline|Iloprost 4×/Day + Placebo 2x/Day + Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan
516565|NCT00302211|B1|Baseline|Iloprost(5 μg) 6×/Day Plus Sildenafil +/- Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
516566|NCT00302211|P5|Participant Flow|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516567|NCT00302211|P4|Participant Flow|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516568|NCT00302211|P3|Participant Flow|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
516608|NCT00302107|E2|Reported Event|Placebo|Placebo up to 3 tablets qhs
516574|NCT00302211|O2|Outcome|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
516575|NCT00302211|O1|Outcome|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
516576|NCT00302211|E5|Reported Event|OL Inhaled Iloprost (5μg) (4x/Day) & Sildenafil ± Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516577|NCT00302211|E4|Reported Event|OL Iloprost (5μg) 6x/Day Plus Sildenafil With/Without Bosentan|Open-Label(OL) inhaled iloprost (5μg)plus sildenafil with or without bosentan
516578|NCT00302211|E3|Reported Event|Placebo 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled placebo 6×/day plus sildenafil with or without bosentan
516579|NCT00302211|E2|Reported Event|Iloprost 4×/Day and Placebo 2x/Day With Sildenafil ± Bosentan|Blinded Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day with sildenafil with or without bosentan
516580|NCT00302211|E1|Reported Event|Iloprost(5 μg) 6×/Day Plus Sildenafil With or Without Bosentan|Blinded Inhaled iloprost(5 μg) 6×/day plus sildenafil with or without bosentan
516581|NCT00302159|B1|Baseline|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516582|NCT00302159|P1|Participant Flow|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516583|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516584|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516585|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516586|NCT00302159|O1|Outcome|Valproic Acid|"Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~adjuvant therapy~Temozolomide: Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid: Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy: External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516587|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516588|NCT00302159|O1|Outcome|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516589|NCT00302159|E1|Reported Event|Valproic Acid|"adjuvant therapy~Temozolomide Orally 75mg/m^2 first day of radiation until completion. Restart 4 weeks post radiation.~Valproic Acid Orally 25mg/kg/day twice a day concurrently with radiation therapy and temozolomide.~Radiation therapy External beam radiation Monday-Friday in 2 Gy fractions to 60 Gy total."
516590|NCT00302133|B3|Baseline|Total|Total of all reporting groups
516591|NCT00302133|B2|Baseline|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
516592|NCT00302133|B1|Baseline|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
516593|NCT00302133|P2|Participant Flow|Placebo|"Placebo add on to valproate open label~Placebo one capsule daily for 12 weeks"
516594|NCT00302133|P1|Participant Flow|Naltrexone|"Naltrexone add on to valproate open label~Naltrexone Hydrochloride 50 mg daily for 12 weeks"
516595|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
516596|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
516597|NCT00302133|O2|Outcome|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
516598|NCT00302133|O1|Outcome|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
516599|NCT00302133|E2|Reported Event|Placebo|"Placebo add on to valproate open label~Placebo add on to open label valproate for 12 weeks"
516600|NCT00302133|E1|Reported Event|Naltrexone|"Naltrexone add on to valproate open label~naltrexone add on to open label valproate: naltrexone 50 mg/day for 12 weeks add on to open label valproate"
516601|NCT00302107|B3|Baseline|Total|Total of all reporting groups
516602|NCT00302107|B2|Baseline|Placebo|Placebo up to three tablets qhs
516603|NCT00302107|B1|Baseline|Mirtazapine|Mirtazapine up to 45 mg/qhs as tolerated
516604|NCT00302107|P2|Participant Flow|Placebo|Placebo up to three pills qhs
516605|NCT00302107|P1|Participant Flow|Mirtazapine|Mirtazapine up to 45mg/qhs (three 15mg pills) as tolerated.
516606|NCT00302107|O2|Outcome|Placebo|Placebo up to 3 tablets qhs
516607|NCT00302107|O1|Outcome|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
516609|NCT00302107|E1|Reported Event|Mirtazapine|Mirtazapine up to 45mg/qhs as tolerated
516610|NCT00302081|B4|Baseline|Total|Total of all reporting groups
516611|NCT00302081|B3|Baseline|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
516612|NCT00302081|B2|Baseline|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
516613|NCT00302081|B1|Baseline|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
516614|NCT00302081|P3|Participant Flow|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
516615|NCT00302081|P2|Participant Flow|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
516616|NCT00302081|P1|Participant Flow|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
516617|NCT00302081|O3|Outcome|PEG2b 1.5/R (16 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 16 weeks
516618|NCT00302081|O2|Outcome|PEG2b 1.0/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg/day for 24 weeks
516619|NCT00302081|O1|Outcome|PEG2b 1.5/R (24 Weeks)|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 mcg/kg QW SC plus ribavirin (SCH 18908) 800-1200 mg daily for 24 weeks
516620|NCT00302081|E3|Reported Event|PEG2b 1.5/R*(16 Weeks)|
516621|NCT00302081|E2|Reported Event|PEG2b 1.0/R*(24 Weeks)|
516622|NCT00302081|E1|Reported Event|PEG2b 1.5/R*(24 Weeks)|
516623|NCT00302068|B4|Baseline|Total|Total of all reporting groups
516624|NCT00302068|B3|Baseline|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516625|NCT00302068|B2|Baseline|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516626|NCT00302068|B1|Baseline|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516627|NCT00302068|P3|Participant Flow|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516628|NCT00302068|P2|Participant Flow|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516629|NCT00302068|P1|Participant Flow|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516630|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516631|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516632|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516633|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516634|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516635|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516636|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516689|NCT00301873|E1|Reported Event|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516637|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516638|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516639|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516640|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516641|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516642|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516643|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516644|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516645|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects..
516646|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516647|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516648|NCT00302068|O3|Outcome|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516649|NCT00302068|O2|Outcome|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516650|NCT00302068|O1|Outcome|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516651|NCT00302068|E3|Reported Event|Placebo Control|Participants are given a matching placebo. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of placebo and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516652|NCT00302068|E2|Reported Event|Sertraline (Zoloft)|Participants are given the selective serotonin reuptake inhibitor sertraline. Medications are taken once daily; the dosage depends on the clinical response, but usually, each patient will start at 50 mg (1 pill) of drug and progress up to 200 mg (4 pills), contingent on therapeutic response and the presence of side effects.
516653|NCT00302068|E1|Reported Event|Supervised Aerobic Exercise|Patients will attend 3 supervised group aerobic exercise sessions per week for 16 weeks. On the basis of peak heart rate achieved during the initial treadmill test, patients are assigned training ranges equivalent to 70% to 85% maximal heart rate reserve. Each aerobic session will consist of 30 min of walking or jogging on a treadmill at an intensity that would maintain heart rate within the assigned training range.
516654|NCT00302055|B3|Baseline|Total|Total of all reporting groups
516655|NCT00302055|B2|Baseline|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
516656|NCT00302055|B1|Baseline|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
516657|NCT00302055|P2|Participant Flow|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
516735|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
516658|NCT00302055|P1|Participant Flow|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
516659|NCT00302055|O2|Outcome|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
516660|NCT00302055|O1|Outcome|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
516661|NCT00302055|E2|Reported Event|Group-based Community Lifestyle|Clinical referral to group diabetes prevention lifestyle intervention program in community
516662|NCT00302055|E1|Reported Event|One-on-one Lifestyle|Clinical referral for diabetes prevention lifestyle intervention at School of Medicine campus
516663|NCT00302042|B3|Baseline|Total|Total of all reporting groups
516664|NCT00302042|B2|Baseline|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
516665|NCT00302042|B1|Baseline|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
516666|NCT00302042|P2|Participant Flow|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
516667|NCT00302042|P1|Participant Flow|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
516668|NCT00302042|O2|Outcome|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
516669|NCT00302042|O1|Outcome|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
516670|NCT00302042|E2|Reported Event|Active Comparator: 2: Brief Counseling Alone|Brief Counseling for pre-diabetes alone without access to group lifestyle
516671|NCT00302042|E1|Reported Event|Experimental: 1: Brief Counseling Plus Group Lifestyle|Brief counseling for pre-diabetes plus access to a group-based diabetes prevention lifestyle intervention in the community
516672|NCT00302003|B1|Baseline|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
516673|NCT00302003|P1|Participant Flow|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
516674|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
516675|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
516676|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
516677|NCT00302003|O1|Outcome|Group 1|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim
516678|NCT00302003|E1|Reported Event|Doxorubicin, Vincristine, Cyclophosphamide and Filgrastim|"Treatment consists of 3 cycles of Doxorubicin hydrochloride IV (25 mg/m2) days 1 & 2, Vincristine sulfate IV (1.4 mg/m2 [max 2.8 mg]) Days 1 & 8, Prednisone orally (40 mg/m2) Days 1-7, Cyclophosphamide IV (600 mg/m2) Days 1 & 2, Filgrastim by mouth or IV (5 micrograms/kg/dose) 24 hours after Cyclophosphamide complete. See detailed description for remainder of therapy.~radiation therapy: Undergo radiation therapy~doxorubicin hydrochloride: Given IV~vincristine sulfate: Given IV~prednisone: Given orally~cyclophosphamide: Given IV~ifosfamide: Given IV~vinorelbine tartrate: Given IV~dexamethasone: Given IV~etoposide phosphate: Given IV~cisplatin: Given IV~cytarabine: Given IV~filgrastim: Given IV or subcutaneously"
516679|NCT00301964|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
516680|NCT00301964|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
516681|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
516682|NCT00301964|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
516683|NCT00301964|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 3 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~laboratory biomarker analysis: Correlative studies"
516684|NCT00301873|B1|Baseline|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516685|NCT00301873|P1|Participant Flow|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516686|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516687|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516688|NCT00301873|O1|Outcome|IV Zometa|Zometa will be given at 4 mg intravenously over 15 minutes every 3 months for 1 year.
516690|NCT00301834|B1|Baseline|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
516691|NCT00301834|P1|Participant Flow|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
516692|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
516693|NCT00301834|O2|Outcome|CMV Seropositive Participants|"seropositivity means the presence of anti-CMV IgG, indicating past infection by the virus"
516694|NCT00301834|O1|Outcome|CMV Seronegative Participants|"seronegativity means no detected presence of anti-CMV IgG, indicating no past infection by the virus"
516695|NCT00301834|O1|Outcome|Single Arm|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
516696|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
516697|NCT00301834|O1|Outcome|Single Arm - Transplant Pre-conditioning Per Study Protocol|Conditioning with Alemtuzumab, busulfan and fludarabine followed by allogeneic hematopoietic cell transplant.
516698|NCT00301834|E1|Reported Event|Single Arm - Transplant Pre-conditioning Per Study Protocol|All eligible patients received pre-transplant conditioning with Alemtuzumab, fludarabine and targeted busulfan followed by allogeneic transplant. The initial dose of busulfan was determined by performing PK (pharmacokinetics) analysis on a test dose of busulfan on the day prior to initiating conditioning. Based on the PK results a starting dose of busulfan was determined. A second PK study was done after the starting dose to ensure that the targeted dose was achieved. If it wasn't achieved, then a dose modification was made and a third PK study done.
516699|NCT00301821|B1|Baseline|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516700|NCT00301821|P1|Participant Flow|Epratuzumab + Rituximab + CHOP|One arm open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate
516701|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516702|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516703|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516704|NCT00301821|O1|Outcome|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516705|NCT00301821|E1|Reported Event|Epratuzumab + Rituximab + CHOP|One arm, open label. Epratuzumab, Rituximab, Cyclophosphamide, Doxorubicin hydrochloride, Prednisone, Vincristine sulfate.
516706|NCT00301808|B1|Baseline|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
516707|NCT00301808|P1|Participant Flow|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
516708|NCT00301808|O1|Outcome|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
516709|NCT00301808|E1|Reported Event|Cisplatin, Docetaxel & Radiation Therapy|"Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43; Docetaxel 75 mg/m2 on day 1 of each cycle; Radiation therapy will begin within 24 hours of the first cycle of chemotherapy.~Cisplatin: Cisplatin 75 mg/m2 every 3 weeks on days 1, 22, and 43~Docetaxel: Docetaxel 75 mg/m2 on day 1 of each cycle~Pemetrexed disodium: Pemetrexed 500 mg/m2 every 3 weeks on days 1, 22, and 43~Radiation therapy: Radiation therapy will begin within 24 hours of the first cycle of chemotherapy."
516710|NCT00301756|B1|Baseline|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
516711|NCT00301756|P1|Participant Flow|Treatment (Belinostat / Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
516712|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
516736|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
516737|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
516713|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
516714|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
516715|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
516716|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|"Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~belinostat: Given IV"
516717|NCT00301756|O1|Outcome|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
516718|NCT00301756|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy)|Patients receive belinostat IV over 30 minutes on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
516719|NCT00301418|B1|Baseline|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516720|NCT00301418|P1|Participant Flow|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516721|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516722|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516723|NCT00301418|O1|Outcome|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516724|NCT00301418|E1|Reported Event|Tarceva (Erlotinib)|Erlotinib: Tarceva®: Will be given at a starting dose of 150mg QD dose for the first cycle which is 28 days. This will be followed by 14 days of 100mg PO on a bid schedule and 150mg PO on a bid schedule for the final 14 days of the second cycle. Assuming no dose limiting toxicity, 150 mg PO tid will be continued for up to 10 more cycles. This is an outpatient regimen, in which the drug is admininistered orally. Tumor response will be assessed after every 2nd treatment cycle. Patients may receive a maximum of 12 cycles of treatment under this research protocol.
516725|NCT00301366|B1|Baseline|Entered Study|
516726|NCT00301366|P1|Participant Flow|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
516727|NCT00301366|O1|Outcome|Alpha-1 MP Treatment Group|
516728|NCT00301366|E1|Reported Event|Alpha-1MP Treatment Group|All subjects received open-label weekly IV infusions of 60 mg/kg body weight of functional Alpha-1 MP for 20 weeks
516729|NCT00301262|B3|Baseline|Total|Total of all reporting groups
516730|NCT00301262|B2|Baseline|Start : DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
516731|NCT00301262|B1|Baseline|Start : DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks).
516732|NCT00301262|P2|Participant Flow|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516733|NCT00301262|P1|Participant Flow|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516734|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
516776|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
516777|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
516778|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
516779|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
516780|NCT00301262|O2|Outcome|DB Placebo Baseline < Week 8|
516781|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
516782|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 8 to <=Week 14|
516783|NCT00301262|O3|Outcome|DB Viagra/OL Viagra Week 8 to <=Week 14|
516784|NCT00301262|O2|Outcome|DB Placebo Baseline to < Week 8|
516785|NCT00301262|O1|Outcome|DB Viagra Baseline < Week 8|
516786|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
516787|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
516788|NCT00301262|O2|Outcome|DB Placebo / OL Viagra|
516789|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
516790|NCT00301262|O2|Outcome|DB Placebo/ OL Viagra|
516791|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|
516792|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516793|NCT00301262|O3|Outcome|DB Placebo Week 8|
516794|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516795|NCT00301262|O1|Outcome|DB Viagra Week 8|
516796|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516797|NCT00301262|O3|Outcome|DB Placebo Week 8|
516798|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516799|NCT00301262|O1|Outcome|DB Viagra Week 8|
516800|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516801|NCT00301262|O3|Outcome|DB Placebo Week 8|
516802|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516803|NCT00301262|O1|Outcome|DB Viagra Week 8|
516804|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516805|NCT00301262|O3|Outcome|DB Placebo Week 8|
516806|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516807|NCT00301262|O1|Outcome|DB Viagra Week 8|
516808|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
516809|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
516810|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
516811|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
516812|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
516813|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
516814|NCT00301262|O2|Outcome|DB Placebo|
516815|NCT00301262|O1|Outcome|DB Viagra|
516816|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516817|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516818|NCT00301262|O2|Outcome|DB Placebo/OL Viagra|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516819|NCT00301262|O1|Outcome|DB Viagra / OL Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks). Subjects started open-label phase on 50 mg Viagra. After 2 weeks of treatment, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of open-label phase (after 6 weeks).
516820|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
516821|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
516822|NCT00301262|O2|Outcome|DB Placebo|Subjects started double-blind phase on matching placebo. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of double-blind phase (after 8 weeks).
518370|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
516823|NCT00301262|O1|Outcome|DB Viagra|Subjects started double-blind phase on 50 mg Viagra. After 2 weeks, subjects were allowed to titrate the dose (up or down) depending on efficacy and tolerability and remained on that dose until the end of the double-blind phase (after 8 weeks)
516824|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
516825|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
516826|NCT00301262|O2|Outcome|Week 8 DB Placebo|
516827|NCT00301262|O1|Outcome|Week 8 DB Viagra|
516828|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
516829|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
516830|NCT00301262|O2|Outcome|Week 8 DB Placebo|
516831|NCT00301262|O1|Outcome|Week 8 DB Viagra|
516832|NCT00301262|O4|Outcome|Week 14 DB Placebo/OL Viagra|
516833|NCT00301262|O3|Outcome|Week 14 DB Viagra/OL Viagra|
516834|NCT00301262|O2|Outcome|Week 8 DB Placebo|
516835|NCT00301262|O1|Outcome|Week 8 DB Viagra|
516836|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516837|NCT00301262|O3|Outcome|DB Placebo Week 8|
516838|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516839|NCT00301262|O1|Outcome|DB Viagra Week 8|
516840|NCT00301262|O2|Outcome|DB Placebo|
516841|NCT00301262|O1|Outcome|DB Viagra|
516842|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516843|NCT00301262|O3|Outcome|DB Placebo Week 8|
516844|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516845|NCT00301262|O1|Outcome|DB Viagra Week 8|
516846|NCT00301262|O2|Outcome|DB Placebo|
516847|NCT00301262|O1|Outcome|DB Viagra|
516848|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516849|NCT00301262|O3|Outcome|DB Placebo Week 8|
516850|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516851|NCT00301262|O1|Outcome|DB Viagra Week 8|
516852|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516853|NCT00301262|O3|Outcome|DB Placebo Week 8|
516854|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516855|NCT00301262|O1|Outcome|DB Viagra Week 8|
516856|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516857|NCT00301262|O3|Outcome|DB Placebo Week 8|
516858|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516859|NCT00301262|O1|Outcome|DB Viagra Week 8|
516860|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516861|NCT00301262|O3|Outcome|DB Placebo Week 8|
516862|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516863|NCT00301262|O1|Outcome|DB Viagra Week 8|
516864|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516865|NCT00301262|O3|Outcome|DB Placebo Week 8|
516866|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516867|NCT00301262|O1|Outcome|DB Viagra Week 8|
516868|NCT00301262|O2|Outcome|DB Placebo|
516869|NCT00301262|O1|Outcome|DB Viagra|
516870|NCT00301262|O2|Outcome|DB Placebo|
516871|NCT00301262|O1|Outcome|DB Viagra|
516872|NCT00301262|O2|Outcome|DB Placebo|
516873|NCT00301262|O1|Outcome|DB Viagra|
516874|NCT00301262|O2|Outcome|DB Placebo|
516875|NCT00301262|O1|Outcome|DB Viagra|
516876|NCT00301262|O2|Outcome|DB Placebo|
516877|NCT00301262|O1|Outcome|DB Viagra|
516878|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516879|NCT00301262|O3|Outcome|DB Placebo Week 8|
516880|NCT00301262|O2|Outcome|DB Viagra /OL Viagra Week 14|
516881|NCT00301262|O1|Outcome|DB Viagra Week 8|
516882|NCT00301262|O2|Outcome|DB Placebo|
516883|NCT00301262|O1|Outcome|DB Viagra|
516884|NCT00301262|O4|Outcome|DB Placebo/OL Viagra Week 14|
516885|NCT00301262|O3|Outcome|DB Placebo Week 8|
516886|NCT00301262|O2|Outcome|DB Viagra/OL Viagra Week 14|
516887|NCT00301262|O1|Outcome|DB Viagra Week 8|
516888|NCT00301262|O2|Outcome|DB Placebo|
516889|NCT00301262|O1|Outcome|DB Viagra|
516890|NCT00301080|B1|Baseline|All Participants (Original Version)|All 7 patients enrolled were during the original version of the study design (2 arms: d-cycloserine 250mg vs. placebo - twice daily for 4 weeks). Since the study went on to change design and then terminate prior to completing accrual, it is not useful to report baseline measures by the original arms/groups.
516891|NCT00301080|P5|Participant Flow|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 12 weeks.
516892|NCT00301080|P4|Participant Flow|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516893|NCT00301080|P3|Participant Flow|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516894|NCT00301080|P2|Participant Flow|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516895|NCT00301080|P1|Participant Flow|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516896|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516897|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516898|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516899|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516900|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516901|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516902|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516903|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516904|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516905|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516906|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516907|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516908|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516909|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516910|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516911|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516912|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516913|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516914|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516915|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516916|NCT00301080|O5|Outcome|Placebo (Revised Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516917|NCT00301080|O4|Outcome|D-cycloserine 50 mg|D-cycloserine administered orally at a dose of 50 mg twice per day for 12 weeks.
516918|NCT00301080|O3|Outcome|D-cycloserine 200mg|D-cycloserine administered orally at a dose of 200 mg twice per day for 12 weeks.
516919|NCT00301080|O2|Outcome|Placebo (Original Version)|Placebo administered orally at a dose of twice per day for 4 weeks.
516920|NCT00301080|O1|Outcome|D-cycloserine 250mg|This was the original active comparator arm (before the design was changed): D-cycloserine administered orally at a dose of 250 mg twice per day for 4 weeks.
516921|NCT00301080|E2|Reported Event|D-cycloserine 250mg|
516922|NCT00301080|E1|Reported Event|Placebo (Original Version)|
516923|NCT00301028|B1|Baseline|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
516924|NCT00301028|P1|Participant Flow|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin Area Under the Curve (AUC) 2 and Paclitaxel 135 mg/m^2 for 6 courses.
516925|NCT00301028|O1|Outcome|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
516926|NCT00301028|E1|Reported Event|Cetuximab + Carboplatin/Paclitaxel|Cetuximab beginning weekly dose 400 mg/m^2 intravenous (IV), and 250 mg/m^2 weeks 2-6; Weekly Carboplatin AUC 2 and Paclitaxel 135 mg/m^2 for 6 courses.
516927|NCT00300885|B3|Baseline|Total|Total of all reporting groups
516928|NCT00300885|B2|Baseline|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516929|NCT00300885|B1|Baseline|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516930|NCT00300885|P2|Participant Flow|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516931|NCT00300885|P1|Participant Flow|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516932|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516933|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516934|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516935|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
517013|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
516936|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516937|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516938|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516939|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516940|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516941|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516942|NCT00300885|O2|Outcome|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516943|NCT00300885|O1|Outcome|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516944|NCT00300885|E2|Reported Event|Placebo + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib Placebo (2 tablets orally twice daily] on Study Days 2-19 and paclitaxel (200 mg/m2, intravenous (IV)) and carboplatin (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib Placebo 2 tablets orally twice daily was administered on Days 1-21 of each 21-day cycle.
516945|NCT00300885|E1|Reported Event|Sorafenib + C/P|Chemotherapy Phase up to 6 cycles: Sorafenib (Nexavar, BAY43-9006), [400 mg orally, twice daily] on Study Days 2-19 and paclitaxel (P) (200 mg/m2, intravenous (IV)) and carboplatin (C) (area under the curve (AUC) =6 mg/ml*min-1, IV) on Study Day 1. The cycle duration 21 days. Maintenance Phase: Sorafenib 400 mg orally twice daily was administered on Days 1-21 of each 21-day cycle.
516946|NCT00300755|B4|Baseline|Total|Total of all reporting groups
516947|NCT00300755|B3|Baseline|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516948|NCT00300755|B2|Baseline|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516949|NCT00300755|B1|Baseline|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516950|NCT00300755|P3|Participant Flow|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516951|NCT00300755|P2|Participant Flow|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516952|NCT00300755|P1|Participant Flow|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516953|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516954|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516955|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516956|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516957|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516958|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
517011|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
516959|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516960|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516961|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516962|NCT00300755|O3|Outcome|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516963|NCT00300755|O2|Outcome|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516964|NCT00300755|O1|Outcome|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516965|NCT00300755|E3|Reported Event|High Dose Pantoprazole (Approximately 1.2 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 15 mg once daily for 8 weeks for patients ≥1 to <2 years. Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 20 mg once daily for 8 weeks for patients from ≥2 to <6 years.
516966|NCT00300755|E2|Reported Event|Medium Dose Pantoprazole (Approximately 0.6 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 10 mg once daily for 8 weeks
516967|NCT00300755|E1|Reported Event|Low Dose Pantoprazole (Approximately 0.3 mg/kg)|Capsules containing pantoprazole sodium-enteric coated spheroids (granules) 5 mg once daily for 8 weeks
516968|NCT00300677|B1|Baseline|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516969|NCT00300677|P1|Participant Flow|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516970|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516971|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516972|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516973|NCT00300677|O1|Outcome|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516974|NCT00300677|E1|Reported Event|Voriconazole|400 mg every 12 hours on Day 1; 200 mg every 12 hours on Day 2; 200 mg on Day 3
516975|NCT00300482|B7|Baseline|Total|Total of all reporting groups
516976|NCT00300482|B6|Baseline|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
516977|NCT00300482|B5|Baseline|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
516978|NCT00300482|B4|Baseline|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
516979|NCT00300482|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
516980|NCT00300482|B2|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
516981|NCT00300482|B1|Baseline|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
516982|NCT00300482|P6|Participant Flow|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
516983|NCT00300482|P5|Participant Flow|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
516984|NCT00300482|P4|Participant Flow|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
516985|NCT00300482|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
516986|NCT00300482|P2|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
516987|NCT00300482|P1|Participant Flow|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
516988|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
516989|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
516990|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
516991|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
516992|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
516993|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
516994|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
516995|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
516996|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
516997|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
516998|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
516999|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517000|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517001|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517002|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517003|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517004|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517005|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517006|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517007|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517008|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517009|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517010|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517012|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517014|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517015|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517016|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517017|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517018|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517019|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517020|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517021|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517022|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517023|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517024|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517025|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517026|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517027|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517028|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517029|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517030|NCT00300482|O6|Outcome|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517031|NCT00300482|O5|Outcome|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517032|NCT00300482|O4|Outcome|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517033|NCT00300482|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517034|NCT00300482|O2|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517035|NCT00300482|O1|Outcome|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517036|NCT00300482|E6|Reported Event|40 mg Rosuvastatin|40 mg rosuvastatin monotherapy once daily
517037|NCT00300482|E5|Reported Event|20 mg Rosuvastatin|20 mg rosuvastatin monotherapy once daily
517038|NCT00300482|E4|Reported Event|10 mg Rosuvastatin|10 mg rosuvastatin monotherapy once daily
517039|NCT00300482|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
517040|NCT00300482|E2|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 + 20 mg rosuvastatin combination therapy once daily
517041|NCT00300482|E1|Reported Event|ABT-335 + 10 mg Rosuvastatin|ABT-335 + 10 mg rosuvastatin combination therapy once daily
517042|NCT00300469|B7|Baseline|Total|Total of all reporting groups
517043|NCT00300469|B6|Baseline|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517044|NCT00300469|B5|Baseline|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517045|NCT00300469|B4|Baseline|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517046|NCT00300469|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
517047|NCT00300469|B2|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517048|NCT00300469|B1|Baseline|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517049|NCT00300469|P6|Participant Flow|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517050|NCT00300469|P5|Participant Flow|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517051|NCT00300469|P4|Participant Flow|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517052|NCT00300469|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
517053|NCT00300469|P2|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517054|NCT00300469|P1|Participant Flow|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517055|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517056|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517057|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517058|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517059|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517060|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517061|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517062|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517063|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517064|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517065|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517066|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517067|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517068|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517069|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517070|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517071|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517072|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517073|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517074|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517075|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517076|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517077|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517143|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517078|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517079|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517080|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517081|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517082|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517083|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517084|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517085|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517086|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517087|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517088|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517089|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517090|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517091|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517092|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517093|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517094|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517095|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517096|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517097|NCT00300469|O6|Outcome|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517098|NCT00300469|O5|Outcome|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517099|NCT00300469|O4|Outcome|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517100|NCT00300469|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517101|NCT00300469|O2|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517102|NCT00300469|O1|Outcome|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517103|NCT00300469|E6|Reported Event|80 mg Atorvastatin|80 mg atorvastatin monotherapy once daily
517104|NCT00300469|E5|Reported Event|40 mg Atorvastatin|40 mg atorvastatin monotherapy once daily
517105|NCT00300469|E4|Reported Event|20 mg Atorvastatin|20 mg atorvastatin monotherapy once daily
517106|NCT00300469|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
517107|NCT00300469|E2|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 + 40 mg atorvastatin combination therapy once daily
517108|NCT00300469|E1|Reported Event|ABT-335 + 20 mg Atorvastatin|ABT-335 + 20 mg atorvastatin combination therapy once daily
517109|NCT00300456|B7|Baseline|Total|Total of all reporting groups
517110|NCT00300456|B6|Baseline|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517111|NCT00300456|B5|Baseline|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517112|NCT00300456|B4|Baseline|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517113|NCT00300456|B3|Baseline|ABT-335|ABT-335 monotherapy once daily
517114|NCT00300456|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517115|NCT00300456|B1|Baseline|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517116|NCT00300456|P6|Participant Flow|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517117|NCT00300456|P5|Participant Flow|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517118|NCT00300456|P4|Participant Flow|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517119|NCT00300456|P3|Participant Flow|ABT-335|ABT-335 monotherapy once daily
517120|NCT00300456|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517121|NCT00300456|P1|Participant Flow|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517122|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517123|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517124|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517125|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517126|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517127|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517128|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517129|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517130|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517131|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517132|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517133|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517134|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517135|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517136|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517137|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517138|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517139|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517140|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517141|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517142|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517144|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517145|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517146|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517147|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517148|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517149|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517150|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517151|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517152|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517153|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517154|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517155|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517156|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517157|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517158|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517159|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517160|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517161|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517162|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517163|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517164|NCT00300456|O6|Outcome|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517165|NCT00300456|O5|Outcome|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517166|NCT00300456|O4|Outcome|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517167|NCT00300456|O3|Outcome|ABT-335|ABT-335 monotherapy once daily
517168|NCT00300456|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517169|NCT00300456|O1|Outcome|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517170|NCT00300456|E6|Reported Event|80 mg Simvastatin|80 mg simvastatin monotherapy once daily
517171|NCT00300456|E5|Reported Event|40 mg Simvastatin|40 mg simvastatin monotherapy once daily
517172|NCT00300456|E4|Reported Event|20 mg Simvastatin|20 mg simvastatin monotherapy once daily
517173|NCT00300456|E3|Reported Event|ABT-335|ABT-335 monotherapy once daily
517174|NCT00300456|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 + 40 mg simvastatin combination therapy once daily
517175|NCT00300456|E1|Reported Event|ABT-335 + 20 mg Simvastatin|ABT-335 + 20 mg simvastatin combination therapy once daily
517176|NCT00300430|B4|Baseline|Total|Total of all reporting groups
517177|NCT00300430|B3|Baseline|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517178|NCT00300430|B2|Baseline|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517179|NCT00300430|B1|Baseline|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517180|NCT00300430|P3|Participant Flow|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517181|NCT00300430|P2|Participant Flow|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517182|NCT00300430|P1|Participant Flow|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517183|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517184|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517185|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517186|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517187|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517188|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517189|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517190|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517191|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517192|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517193|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517194|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517195|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517196|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517197|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517198|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517199|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517200|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517201|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517202|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517203|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517204|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517205|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517206|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517207|NCT00300430|O3|Outcome|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517208|NCT00300430|O2|Outcome|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517209|NCT00300430|O1|Outcome|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517210|NCT00300430|E3|Reported Event|ABT-335 + 40 mg Atorvastatin|ABT-335 and 40 mg atorvastatin combination therapy
517211|NCT00300430|E2|Reported Event|ABT-335 + 40 mg Simvastatin|ABT-335 and 40 mg simvastatin combination therapy
517212|NCT00300430|E1|Reported Event|ABT-335 + 20 mg Rosuvastatin|ABT-335 and 20 mg rosuvastatin combination therapy
517213|NCT00300274|B4|Baseline|Total|Total of all reporting groups
517214|NCT00300274|B3|Baseline|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517215|NCT00300274|B2|Baseline|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517216|NCT00300274|B1|Baseline|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517217|NCT00300274|P3|Participant Flow|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517218|NCT00300274|P2|Participant Flow|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517219|NCT00300274|P1|Participant Flow|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517220|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517221|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517222|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517223|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517224|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517225|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517226|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517227|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517228|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517229|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517230|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517293|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517231|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517232|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517233|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517234|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517235|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517236|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517237|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517238|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517239|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517240|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517241|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517242|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517243|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517244|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517245|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517246|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517247|NCT00300274|O3|Outcome|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517248|NCT00300274|O2|Outcome|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517249|NCT00300274|O1|Outcome|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517250|NCT00300274|E3|Reported Event|Mycophenolate Mofetil|Within 72 hours after transplantation participants received 3 tablets 500 mg mycophenolate mofetil twice a day 12 hours apart for a total daily dose of 3000 mg in combination with a standard cyclosporine dose and standard dose corticosteroids for 24 months.
517294|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
518371|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
517251|NCT00300274|E2|Reported Event|Everolimus 3.0 mg|Within 72 hours after transplantation participants received 1.5 mg everolimus tablets twice a day 12 hours apart for a total 3.0 mg daily dose in combination with reduced cyclosporine and standard dose corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 6-12 ng/mL.
517252|NCT00300274|E1|Reported Event|Everolimus 1.5 mg|Within 72 hours after transplantation participants received 0.75 mg everolimus tablets twice a day 12 hours apart for a total 1.5 mg daily dose in combination with reduced cyclosporine and standard corticosteroids for 24 months. The everolimus dose could be adjusted to maintain a target everolimus trough level of 3-8 ng/mL.
517253|NCT00300235|B6|Baseline|Total|Total of all reporting groups
517254|NCT00300235|B5|Baseline|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
517255|NCT00300235|B4|Baseline|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
517256|NCT00300235|B3|Baseline|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
517257|NCT00300235|B2|Baseline|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
517258|NCT00300235|B1|Baseline|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
517259|NCT00300235|P5|Participant Flow|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
517260|NCT00300235|P4|Participant Flow|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
517261|NCT00300235|P3|Participant Flow|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
517262|NCT00300235|P2|Participant Flow|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
517263|NCT00300235|P1|Participant Flow|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
517264|NCT00300235|O5|Outcome|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
517265|NCT00300235|O4|Outcome|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
517266|NCT00300235|O3|Outcome|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
517267|NCT00300235|O2|Outcome|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
517268|NCT00300235|O1|Outcome|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
517269|NCT00300235|E5|Reported Event|Age >15 HbSC/HbSβ+|Subjects > 15 yrs w/SCD diagnosis HbSC/HbSβ+
517270|NCT00300235|E4|Reported Event|Age >25 HbSS/HbSβ0|Subjects > 25 yrs w/SCD diagnosis HbSS/HbSβ0
517271|NCT00300235|E3|Reported Event|Age 15-24.9 HbSS/HbSβ0|Subjects 15 to 24.9 yrs w/SCD diagnosis HbSS/HbSβ0
517272|NCT00300235|E2|Reported Event|Age 10-14.9 HbSS/HbSβ0|Subjects 10 to 14.9 ys w/SCD diagnosis HbSS/HbSβ0
517273|NCT00300235|E1|Reported Event|Age 5-9.9 HbSS/HbSβ0|Subjects 5 to 9.9 yrs w/SCD diagnosis HbSS/HbSβ0
517274|NCT00299975|B4|Baseline|Total|Total of all reporting groups
517275|NCT00299975|B3|Baseline|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517276|NCT00299975|B2|Baseline|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517277|NCT00299975|B1|Baseline|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517278|NCT00299975|P3|Participant Flow|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517279|NCT00299975|P2|Participant Flow|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517280|NCT00299975|P1|Participant Flow|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517281|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517282|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517283|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517284|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517285|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517286|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517287|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517288|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517289|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517290|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517291|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517292|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517295|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517296|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517297|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517298|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517299|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517300|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517301|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517302|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517303|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517304|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517305|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517306|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517307|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517308|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517309|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517310|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517311|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517312|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517313|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517314|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517315|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517316|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517317|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517318|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517319|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517320|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517321|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517322|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517323|NCT00299975|O3|Outcome|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517324|NCT00299975|O2|Outcome|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517325|NCT00299975|O1|Outcome|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517326|NCT00299975|E3|Reported Event|High Dose Group|MaZiRenWan (MZRW) 7.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517327|NCT00299975|E2|Reported Event|Median Dose Group|MaZiRenWan (MZRW) 5.0g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517328|NCT00299975|E1|Reported Event|Low Dose Group|MaZiRenWan (MZRW) 2.5g/sachet Patients were instructed to dissolve a sachet of granules in 150 ml of hot water; they took this solution orally twice daily for 8 weeks.
517329|NCT00299741|B1|Baseline|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
517330|NCT00299741|P1|Participant Flow|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib administered orally at a dosage of 37.5 mg once daily
517331|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
517332|NCT00299741|O1|Outcome|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
517333|NCT00299741|E1|Reported Event|Metastatic Prostate Cancer Treated With Sunitinib|Sunitinib
517334|NCT00299702|B3|Baseline|Total|Total of all reporting groups
517335|NCT00299702|B2|Baseline|Abilify|10-30 mg once daily oral for 104 weeks
517336|NCT00299702|B1|Baseline|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
517337|NCT00299702|P2|Participant Flow|Abilify|10-30 mg once daily oral for 104 weeks
517338|NCT00299702|P1|Participant Flow|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
517339|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
517340|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
517341|NCT00299702|O2|Outcome|Abilify|10-30 mg once daily oral for 104 weeks
517342|NCT00299702|O1|Outcome|Risperdal Consta|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
517343|NCT00299702|E2|Reported Event|Abilify|10-30 mg once daily oral for 104 weeks
517344|NCT00299702|E1|Reported Event|RISPERDAL CONSTA|25mg, 37.5mg, or 50mg every 2 weeks injection for 104 weeks
517345|NCT00299689|B1|Baseline|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
517346|NCT00299689|P1|Participant Flow|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
517347|NCT00299689|O1|Outcome|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
517348|NCT00299689|E1|Reported Event|Intervention|"Single-arm: Ontak~Denileukin diftitox : 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles."
517349|NCT00299546|B4|Baseline|Total|Total of all reporting groups
517350|NCT00299546|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517351|NCT00299546|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
517352|NCT00299546|B1|Baseline|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
517353|NCT00299546|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517354|NCT00299546|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); Golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
517355|NCT00299546|P1|Participant Flow|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); Golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; Golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-24 database lock.
517356|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
517357|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517358|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517359|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517360|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
517361|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517362|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517716|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517363|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517364|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
517365|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517366|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517367|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517368|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
517369|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517370|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517371|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517372|NCT00299546|O4|Outcome|Combined Golimumab|Combines Group 2 (golimumab 50 mg) and Group 3 (golimumab 100 mg).
517373|NCT00299546|O3|Outcome|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50 mg. Duration of the blinded period was until the week-24 database lock.
517374|NCT00299546|O2|Outcome|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 up to 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injections every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517375|NCT00299546|O1|Outcome|Group 1: Placebo|Placebo Subcutaneous (SC) injections every 4 weeks (wks) thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injections from Wk 16 up to 5 yrs; golimumab - 50 mg SC injections beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg. Duration of the blinded period was until the week-24 database lock.
517376|NCT00299546|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study.
517377|NCT00299546|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study.
517378|NCT00299546|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study.
517379|NCT00299416|B1|Baseline|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517380|NCT00299416|P1|Participant Flow|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517381|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517382|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517383|NCT00299416|O1|Outcome|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517384|NCT00299416|E1|Reported Event|Caffeinol|Caffeinol will be administered over a 2 hour infusion period. Dosage of caffeinol is based on on-going dose escalation trials and based on the patients weight. Currently the dosage is: ethanol 10% (0.4gm/kg) and caffeine 9 mg/kg.
517385|NCT00299221|B3|Baseline|Total|Total of all reporting groups
517386|NCT00299221|B2|Baseline|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517387|NCT00299221|B1|Baseline|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517388|NCT00299221|P2|Participant Flow|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517389|NCT00299221|P1|Participant Flow|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517390|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517391|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517392|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517393|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517394|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517395|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517396|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517397|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517398|NCT00299221|O2|Outcome|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517399|NCT00299221|O1|Outcome|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517400|NCT00299221|E2|Reported Event|Combination Therapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be maintained in this group, unless intolerance develops.
517401|NCT00299221|E1|Reported Event|Monotherapy|These patients will receive tacrolimus, mycophenolate mofetil (MMF) and corticosteroids, followed by a rapid 8 week wean of steroids to discontinuation. MMF will be discontinued in this group at 14 days post-transplant
517402|NCT00299156|B4|Baseline|Total|Total of all reporting groups
517403|NCT00299156|B3|Baseline|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517404|NCT00299156|B2|Baseline|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517405|NCT00299156|B1|Baseline|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517406|NCT00299156|P3|Participant Flow|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517407|NCT00299156|P2|Participant Flow|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517408|NCT00299156|P1|Participant Flow|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517409|NCT00299156|O3|Outcome|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517410|NCT00299156|O2|Outcome|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517411|NCT00299156|O1|Outcome|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517412|NCT00299156|E3|Reported Event|Randomized, Oral Clofarabine 20mg|Arm B: 20 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517413|NCT00299156|E2|Reported Event|Randomized, Oral Clofarabine 10mg|Arm A: 10 mg tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517414|NCT00299156|E1|Reported Event|Oral Clofarabine|Original dose of 40 mg oral reduced to 30mg and than lower dose of either 10 mg (Group 1) or 20 mg (Group 2) tablets once a day for 5 days in a row and repeated every 4-8 week cycle.
517415|NCT00299130|B4|Baseline|Total|Total of all reporting groups
517416|NCT00299130|B3|Baseline|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517417|NCT00299130|B2|Baseline|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517717|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517418|NCT00299130|B1|Baseline|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517419|NCT00299130|P3|Participant Flow|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517420|NCT00299130|P2|Participant Flow|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517421|NCT00299130|P1|Participant Flow|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 milligrams (mg) intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517422|NCT00299130|O1|Outcome|Rituximab + MTX|"Participants received 0.5 g or 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517423|NCT00299130|O2|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517424|NCT00299130|O1|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517425|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517426|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517427|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517428|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517526|NCT00299104|P3|Participant Flow|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517429|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517430|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517431|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517432|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517433|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517434|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517435|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517436|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517437|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517438|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517439|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517451|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517440|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517441|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517442|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517443|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517444|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517445|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517446|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517447|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517448|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517449|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517450|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517527|NCT00299104|P2|Participant Flow|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
518111|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
517452|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517453|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517454|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517455|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517456|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517457|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517458|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517459|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517460|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517461|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517462|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517528|NCT00299104|P1|Participant Flow|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517718|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517463|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517464|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517465|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517466|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517467|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517468|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517469|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517470|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517471|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517472|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517473|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517496|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517474|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517475|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517476|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517477|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517478|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517479|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517480|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517481|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517482|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517483|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517484|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517508|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517485|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517486|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517487|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517488|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517489|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517490|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517491|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517492|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517493|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517494|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517495|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517524|NCT00299104|B2|Baseline|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
518008|NCT00297427|B3|Baseline|Total|Total of all reporting groups
517497|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517498|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517499|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517500|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517501|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517502|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517503|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517504|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517505|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517506|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517507|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517525|NCT00299104|B1|Baseline|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517640|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
517509|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517510|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517511|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517512|NCT00299130|O3|Outcome|Rituximab 2 x 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517513|NCT00299130|O2|Outcome|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone.~Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517514|NCT00299130|O1|Outcome|Placebo + MTX|"Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517515|NCT00299130|E7|Reported Event|Rituximab 2 x 1.0 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
517516|NCT00299130|E6|Reported Event|Rituximab 2 x 0.5 g + MTX – Extended Safety Follow-up Period|Participants received no treatment during the extended safety follow-up period.
517517|NCT00299130|E5|Reported Event|Switch Population: Rituximab|Includes all data from the point of switch for participants who switched from Placebo + Methotrexate to treatment with rituximab.
517518|NCT00299130|E4|Reported Event|Switch Population: Placebo + MTX|Includes all data up to the point of switch for participants in the Placebo + Methotrexate treatment group who switched to treatment with rituximab after Week 24.
517519|NCT00299130|E3|Reported Event|Rituximab 1.0 g + MTX|"Participants received 1.0 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517520|NCT00299130|E2|Reported Event|Rituximab 2 x 0.5 g + MTX|"Participants received 0.5 g rituximab administered by intravenous infusion on Days 1 and 15. After Week 24, participants received further courses of rituximab every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of methotrexate and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517521|NCT00299130|E1|Reported Event|Placebo + MTX|"Includes all data for participants who remained on placebo, and data up to the point of switch if the participant switched to treatment with rituximab.~Participants received placebo intravenous infusion on Days 1 and 15. From Week 16 onwards, participants could switch to receive rituximab 0.5 g (on Days 1 and 15) every 24 weeks for up to 5 years if they were not in clinical remission and safety criteria were met. Placebo and rituximab infusions were preceded with 100 mg intravenous methylprednisolone. Participants also received a stable dose of 10-25 mg/week of MTX and ≥ 5 mg/week folic acid for the duration of their participation in the study.~All participants entered a 48-week safety follow-up (SFU) period following the treatment period."
517522|NCT00299104|B4|Baseline|Total|Total of all reporting groups
517523|NCT00299104|B3|Baseline|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517641|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
518112|NCT00297115|O2|Outcome|Placebo|once daily
517529|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517530|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517531|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517532|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517533|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517534|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517535|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517536|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517537|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517538|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517539|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517540|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517541|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517542|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517543|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517544|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517642|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
518009|NCT00297427|B2|Baseline|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
517545|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517546|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517547|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517548|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517549|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517550|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517551|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517552|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517553|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517554|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517555|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517556|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517557|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517558|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517559|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517560|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517643|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
518010|NCT00297427|B1|Baseline|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
517561|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517562|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517563|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517564|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517565|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517566|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517567|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517568|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517569|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517570|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517571|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517572|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517573|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517574|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517575|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517576|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517609|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
518372|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
517577|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517578|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517579|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517580|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517581|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517582|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517583|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517584|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517585|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517586|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517587|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517588|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517589|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517590|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517591|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517592|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517638|NCT00298766|P1|Participant Flow|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
518011|NCT00297427|P2|Participant Flow|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
517593|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517594|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517595|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517596|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517597|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517598|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517599|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517600|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517601|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517602|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517603|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517604|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517605|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517606|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517607|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517608|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517639|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
518012|NCT00297427|P1|Participant Flow|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
517610|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517611|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517612|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517613|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517614|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517615|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517616|NCT00299104|O3|Outcome|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517617|NCT00299104|O2|Outcome|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517618|NCT00299104|O1|Outcome|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517619|NCT00299104|E3|Reported Event|Rituximab (1.0 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 1.0 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517620|NCT00299104|E2|Reported Event|Rituximab (0.5 g x 2) + Methotrexate|"Rituximab intravenously at a dose of 0.5 g on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~Subsequent Rituximab treatment courses were given at 24 week intervals for 5 years provided the Disease Activity Score 28 Joint Count- Erythrocyte Sedimentation Rate (DAS-ESR) result was ≥2.6"
517621|NCT00299104|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously on Days 1 and 15 + a background of methotrexate orally at a dose of 7.5 mg escalating by 2.5 mg a week every 1-2 weeks to achieve: 15 mg per week by Week 4 and 20 mg per week by Week 8.~From Week 104 participants were eligible to receive Rituximab 2 X 0.5 g or Rituximab 2 X 1.0 g every 24 weeks."
517622|NCT00299000|B3|Baseline|Total|Total of all reporting groups
517623|NCT00299000|B2|Baseline|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517624|NCT00299000|B1|Baseline|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517625|NCT00299000|P2|Participant Flow|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517626|NCT00299000|P1|Participant Flow|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517627|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517628|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517629|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517630|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517631|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517632|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517633|NCT00299000|O2|Outcome|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517634|NCT00299000|O1|Outcome|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517635|NCT00299000|E2|Reported Event|Naglazyme, 2.0 mg/kg|weekly infusions for minimum of 52 weeks
517636|NCT00299000|E1|Reported Event|Naglazyme, 1.0 mg/kg|weekly infusions for minimum of 52 weeks
517637|NCT00298766|B1|Baseline|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
517714|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517644|NCT00298766|O1|Outcome|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
517645|NCT00298766|E1|Reported Event|Single Agent VELCADE|Bortezomib 0.7, 1.0, 1.3 and 1.6 mg/m^2 once weekly (QW) 4 doses in a 5 week cycle, and 0.7, 1.0, 1.3 mg/m^2 twice weekly (BIW) 4 doses in a 3 week cycle
517646|NCT00298558|B5|Baseline|Total|Total of all reporting groups
517647|NCT00298558|B4|Baseline|Control|This group did not complete any cognitive training interventions
517648|NCT00298558|B3|Baseline|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517649|NCT00298558|B2|Baseline|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517650|NCT00298558|B1|Baseline|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517651|NCT00298558|P4|Participant Flow|Control|This group did not complete any cognitive training interventions
517652|NCT00298558|P3|Participant Flow|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517653|NCT00298558|P2|Participant Flow|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517654|NCT00298558|P1|Participant Flow|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517655|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517656|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517657|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517658|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517659|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517660|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517661|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517662|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517663|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517664|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517665|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517666|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517667|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517668|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517669|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517670|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517671|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517672|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517673|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517674|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517675|NCT00298558|O4|Outcome|Control|This group did not complete any cognitive training interventions
517715|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517676|NCT00298558|O3|Outcome|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517677|NCT00298558|O2|Outcome|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517678|NCT00298558|O1|Outcome|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517679|NCT00298558|E4|Reported Event|Control|This group did not complete any cognitive training interventions
517680|NCT00298558|E3|Reported Event|Speed of Processing Training|Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
517681|NCT00298558|E2|Reported Event|Reasoning Training|Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
517682|NCT00298558|E1|Reported Event|Memory Training|Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
517683|NCT00298363|B4|Baseline|Total|Total of all reporting groups
517684|NCT00298363|B3|Baseline|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517685|NCT00298363|B2|Baseline|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517686|NCT00298363|B1|Baseline|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517687|NCT00298363|P3|Participant Flow|Entecavir|Participants in this group were randomized to receive DB ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
517688|NCT00298363|P2|Participant Flow|FTC/TDF|Participants in this group were randomized to receive DB FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to OL FTC/TDF.
517689|NCT00298363|P1|Participant Flow|Tenofovir DF|Participants in this group were randomized to receive double-blind (DB) TDF 300 mg + FTC)/TDF placebo + ETV placebo at baseline, and may have been unblinded (due to either lack of adequate decrease of HBV DNA or virologic breakthrough) and switched to open-label (OL) FTC/TDF (this study enrolled participants with decompensated liver disease, and early intervention strategies were provided if profound viral suppression was not achieved quickly).
517690|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517691|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517692|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517693|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517694|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517695|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517696|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517697|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517698|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517699|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517700|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517701|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517702|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517703|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517704|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517705|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517706|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517707|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
517708|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517709|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517710|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517711|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517712|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517713|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517719|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517720|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517721|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517722|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517723|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517724|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517725|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517726|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517727|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517728|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517729|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517730|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517731|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517732|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517733|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517734|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517735|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517736|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517737|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517738|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517739|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517740|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517741|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517742|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517743|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517744|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517745|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517746|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517747|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517748|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517749|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517750|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517751|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517752|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517753|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517754|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517755|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517756|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517757|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517758|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517759|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517760|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517761|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517762|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517763|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517764|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517765|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517766|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517767|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517768|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517769|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517770|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517771|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517772|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517773|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517774|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517775|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517776|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517777|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517778|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517779|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517780|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517781|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517782|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517783|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517784|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517785|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517786|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517787|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517788|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517789|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517790|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517791|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517792|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517793|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517794|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517795|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517796|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517797|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517798|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517799|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517800|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517801|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517802|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517803|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517804|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517805|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517806|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517807|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517808|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517809|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517810|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517811|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517812|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517813|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517814|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517815|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517816|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517817|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517818|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517819|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517820|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517821|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517822|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517823|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517824|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517825|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517826|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517827|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517828|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517829|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517830|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517831|NCT00298363|O4|Outcome|Overall|Participants in this group includes all participants from TDF, FTC/TDF, and ETV groups
517832|NCT00298363|O3|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517833|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517834|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517835|NCT00298363|O4|Outcome|Entecavir|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo at baseline
517836|NCT00298363|O3|Outcome|TDF or FTC/TDF|Participants in this group include all participants who received TDF or FTC/TDF during the study.
517837|NCT00298363|O2|Outcome|FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo at baseline
517838|NCT00298363|O1|Outcome|Tenofovir DF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo at baseline
517839|NCT00298363|E5|Reported Event|All TDF|Participants in this group received a TDF-containing treatment (all double-blind TDF, FTC/TDF, or open-label FTC/TDF) during the study.
517840|NCT00298363|E4|Reported Event|Open Label FTC/TDF|Participants in this group were randomized to receive TDF, FTC/TDF, or ETV at the beginning of the study, but switched to open label FTC/TDF during the study.
517841|NCT00298363|E3|Reported Event|Double Blind ETV|Participants in this group were randomized to receive ETV 0.5 mg or 1 mg + TDF placebo + FTC/TDF placebo
517842|NCT00298363|E2|Reported Event|Double Blind FTC/TDF|Participants in this group were randomized to receive FTC 200 mg/TDF 300 mg + TDF placebo + ETV placebo
517843|NCT00298363|E1|Reported Event|Double Blind TDF|Participants in this group were randomized to receive TDF 300 mg + FTC/TDF placebo + ETV placebo
517844|NCT00298272|B3|Baseline|Total|Total of all reporting groups
517845|NCT00298272|B2|Baseline|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517846|NCT00298272|B1|Baseline|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517847|NCT00298272|P2|Participant Flow|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
518013|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518373|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
517848|NCT00298272|P1|Participant Flow|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517849|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517850|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517851|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517852|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517853|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517854|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517855|NCT00298272|O2|Outcome|Double-blind Placebo/Open Label Rituximab|"The double-blind placebo treatment group received saline solution IV on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517856|NCT00298272|O1|Outcome|Double-blind/Open Label Rituximab|"The double-blind rituximab treatment group received rituximab 500 mg by intravenous (IV) infusion on Day 1 and Day 15. After 24 weeks (primary endpoint completion), participants continued post-treatment follow-up (PTFU) visits through Week 56, and entered a 48-week Safety Follow-Up (SFU). At any time between Week 24 and Week 40 of PTFU, eligible participants could enter the rituximab open label (OL) arm, and restart the 56-week treatment/follow-up schedule (rituximab 500 mg by IV infusion on Day 1 and Day 15) prior to the 48-week SFU."
517857|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517858|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517859|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517860|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517861|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517862|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517863|NCT00298272|O2|Outcome|Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
518374|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
517864|NCT00298272|O1|Outcome|Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517865|NCT00298272|E3|Reported Event|Cumulative Rituximab|The cumulative rituximab treatment group included all participants who received rituximab at any time during the study, including participants who received rituximab in the double-blind period and did not participate in the OL period, those who received placebo in the double-blind period and rituximab in the OL, and those who received rituximab in the double-blind and OL periods. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517866|NCT00298272|E2|Reported Event|Double-Blind Placebo|The placebo treatment group received saline solution IV on Day 1 and Day 15. Prior to each infusion of placebo, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517867|NCT00298272|E1|Reported Event|Double-Blind Rituximab|The rituximab treatment group received rituximab 500 mg by intravenous infusion (IV) on Day 1 and Day 15. Prior to rituximab infusion, participants were premedicated with methylprednisolone 100 mg IV. Participants were also to receive a stable dose of folate ≥5 mg weekly.
517868|NCT00298233|B3|Baseline|Total|Total of all reporting groups
517869|NCT00298233|B2|Baseline|Double Dose Oseltamivir|All participants that were randomized and received doubledose oseltamivir
517870|NCT00298233|B1|Baseline|Standarad Dose Oseltamivir|All participants that were randomized and received standard dose oseltamivir
517871|NCT00298233|P4|Participant Flow|Double Dose Oseltamivir Child Cohort|All Participants <15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
517872|NCT00298233|P3|Participant Flow|Standard Dose Oseltamivir Child Cohort|All participants <15 years received standard dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
517873|NCT00298233|P2|Participant Flow|Double Dose Oseltamivir Adult Cohort|All Participants >= 15 years received high-dose oseltamivir (150 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
517874|NCT00298233|P1|Participant Flow|Standard Dose Oseltamivir Adult Cohort|All participants >= 15 years received standard-dose oseltamivir (75 mg twice daily orally or equivalent dose adjusted for age, weight, and kidney function) for 5 to 10 days.
517875|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517876|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517877|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517878|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517879|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517880|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517881|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517882|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517883|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517884|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517885|NCT00298233|O2|Outcome|Standard Dose Oseltamivir|All participants receiving standard dose oseltamivir
517886|NCT00298233|O1|Outcome|Double Dose Oseltamivir|All participants receiving double dose oseltamivir
517887|NCT00298233|E2|Reported Event|Standard Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
517888|NCT00298233|E1|Reported Event|Double Dose Oseltamivir|The study recorded only cumulative data (total number of adverse events (AEs) per type, per Arm, but not number of subjects affected per AE type). Therefore data are the number of events and not the number of participants with events.
517889|NCT00298090|B1|Baseline|StO2 Values|StO2 values pre and post arterial line placement.
517890|NCT00298090|P1|Participant Flow|StO2 Values Pre and Post Arterial Line Placement|single arm study of StO2 in subjects undergoing placement of arterial line. Measurements of StO2 will be taken before and after arterial line placement.
517891|NCT00298090|O1|Outcome|StO2 Values|StO2 pre and post catheter placement
517892|NCT00298090|E1|Reported Event|StO2|StO2 measurements pre and post arterial line catheter placement.
517893|NCT00297830|B4|Baseline|Total|Total of all reporting groups
517894|NCT00297830|B3|Baseline|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517895|NCT00297830|B2|Baseline|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517896|NCT00297830|B1|Baseline|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517897|NCT00297830|P3|Participant Flow|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517898|NCT00297830|P2|Participant Flow|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517899|NCT00297830|P1|Participant Flow|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517900|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
518375|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
517901|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517902|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517903|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517904|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517905|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517906|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517907|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517908|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517909|NCT00297830|O3|Outcome|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517910|NCT00297830|O2|Outcome|Placebo Zoledronic Acid and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.
517911|NCT00297830|O1|Outcome|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517912|NCT00297830|E3|Reported Event|Reference Group|The reference group included concurrently transplanted patients with T scores of -1.5 or greater.
517913|NCT00297830|E2|Reported Event|Placebo Infusion and Active Alendronate|Group 2 will receive an infusion of placebo during the first 5 weeks after transplantation. Active alendronate 70 mg once weekly will be initiated at the same time as the placebo infusion.https://register.clinicaltrials.gov/prs/html/results_definitions.html#Result_ParticipantFlow_Period_title
517914|NCT00297830|E1|Reported Event|Active Zoledronic Acid and Placebo Alendronate|Group 1 will receive an infusion of active zoledronic acid 5 mg during the first 4 weeks after transplantation. Placebo alendronate 70 mg once weekly will be initiated at the same time as the first zoledronic acid infusion.
517915|NCT00297778|B3|Baseline|Total|Total of all reporting groups
517916|NCT00297778|B2|Baseline|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517917|NCT00297778|B1|Baseline|Placebo|Placebo tablet matching active treatment
517918|NCT00297778|P2|Participant Flow|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517919|NCT00297778|P1|Participant Flow|Placebo|Placebo tablet matching active treatment
517920|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517921|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517922|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517923|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517924|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517925|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517926|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517927|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517928|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517929|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517930|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517931|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517932|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517933|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517934|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517935|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517936|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517937|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
518014|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
518376|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
517938|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517939|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517940|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517941|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517942|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517943|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517944|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517945|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517946|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517947|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517948|NCT00297778|O2|Outcome|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517949|NCT00297778|O1|Outcome|Placebo|Placebo tablet matching active treatment
517950|NCT00297778|E2|Reported Event|Pramipexole|Ascending dose titration of Pramipexole. Pramipexole doses consisted of 0.125 mg three times daily (t.i.d), 0.25mg t.i.d, 0.5mg, t.i.d, 0.25mg+0.5mg t.i.d and 1.0 mg t.i.d.
517951|NCT00297778|E1|Reported Event|Placebo|Placebo tablet matching active treatment
517952|NCT00297648|B1|Baseline|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517953|NCT00297648|P1|Participant Flow|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517954|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517955|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517956|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517957|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517958|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517959|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517960|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
518015|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518016|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
517961|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517962|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517963|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517964|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517965|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517966|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517967|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517968|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517969|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517970|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517971|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517972|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517973|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
518017|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518018|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518019|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
517974|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517975|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517976|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517977|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517978|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517979|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517980|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517981|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517982|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517983|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517984|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517985|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517986|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
518020|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
518021|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice a week for 6 weeks
518022|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: True acupuncture twice weekly for 6 weeks
517987|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517988|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517989|NCT00297648|O1|Outcome|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517990|NCT00297648|E1|Reported Event|CDP870 400 mg|Certolizumab pegol (CDP870) 400 mg administered at Weeks 0, 2 and 4 (induction doses), then every 4 weeks (Q4W) until Week 52. Investigators can escalate dosage to CDP870 400 mg 2-weekly (Q2W) at any time after Week 10 for lack of response/remission. After Week 52 patients can continue to receive treatment until study drug is approved and available on the market, according to their administration frequency at Week 52 or transition to a standard care regimen or medical need program according to local regulations.
517991|NCT00297596|B1|Baseline|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
517992|NCT00297596|P1|Participant Flow|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
517993|NCT00297596|O1|Outcome|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
517994|NCT00297596|E1|Reported Event|Oxaliplatin/Trastuzumab|Patients with HER2 positive breast cancer received treatment with oxaliplatin 130 mg/m2 IV day 1 and trastuzumab 6 mg/kg (following 8 mg/kg loading dose during cycle 1). Cycles were repeated every 21 days. Oxaliplatin : Oxaliplatin will be administered at a dose of 130 mg/ m2 over 120 minutes on day 1 of each cycle, following standard antiemetic premedications. 21 day cycles. For the first cycle, trastuzumab will be administered before oxaliplatin; however for subsequent cycles, oxaliplatin will be infused prior to trastuzumab Trastuzumab : Trastuzumab will be administered as an 8 mg/kg loading dose by intravenous (IV) infusion over 90 minutes on day 1 of cycle 1. Subsequent doses will be administered as a 6 mg/kg IV dose over 30 minutes.
517995|NCT00297492|B4|Baseline|Total|Total of all reporting groups
517996|NCT00297492|B3|Baseline|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
517997|NCT00297492|B2|Baseline|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
517998|NCT00297492|B1|Baseline|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
517999|NCT00297492|P3|Participant Flow|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
518000|NCT00297492|P2|Participant Flow|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
518001|NCT00297492|P1|Participant Flow|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
518002|NCT00297492|O3|Outcome|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office; nicotine lozenges were provided for use starting on the quit date.
518003|NCT00297492|O2|Outcome|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date; nicotine lozenges were provided for use starting on the quit date.
518004|NCT00297492|O1|Outcome|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date; nicotine lozenges were provided to aid reduction prior to the quit date and for use on and following the quit date.
518005|NCT00297492|E3|Reported Event|Minimal Intervention|Minimal intervention to mimic intervention at a primary care office
518006|NCT00297492|E2|Reported Event|Abrupt Cessation|Counseling of smokers to set a quit date and not change cigarettes per day prior to quit date
518007|NCT00297492|E1|Reported Event|Gradual Reduction|Counseling of smokers to undergo gradual reduction in cigarettes per day prior to quit date
518023|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
518024|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
518025|NCT00297427|O2|Outcome|Non-responders|Less than a 50% reduction in incontinent episodes following true acupuncture
518026|NCT00297427|O1|Outcome|Responders|50% or greater reduction in incontinent episodes following true acupuncture
518027|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518028|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
518029|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518030|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
518031|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518032|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518033|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518034|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518035|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518036|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518037|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518038|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518039|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518040|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture twice weekly for 6 weeks
518041|NCT00297427|O1|Outcome|True Acupuncture|True Acupuncture twice weekly for 6 weeks.
518042|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518043|NCT00297427|O1|Outcome|Acupuncture|Ture acupuncture twice a week for 6 weeks
518044|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518045|NCT00297427|O1|Outcome|Acupuncture|True acupuncture twice a week for 6 weeks
518046|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518047|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518048|NCT00297427|O2|Outcome|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518049|NCT00297427|O1|Outcome|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518050|NCT00297427|E2|Reported Event|Sham Acupuncture|Sham acupuncture: Twice a week for 6 weeks
518051|NCT00297427|E1|Reported Event|Acupuncture|Acupuncture: Acupuncture twice weekly for 6 weeks.
518052|NCT00297258|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
518053|NCT00297258|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
518054|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
518055|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518056|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518057|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
518058|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
518059|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518060|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518061|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
518062|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
518063|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518064|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518065|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
518066|NCT00297258|O4|Outcome|Pazopanib 800mg - Other Soft Tissue Sarcoma (STS)|Pazopanib 800 mg (tablets) administered orally once a day
518067|NCT00297258|O3|Outcome|Pazopanib 800 mg - Synovial Sarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518068|NCT00297258|O2|Outcome|Pazopanib 800 mg - Leiomyosarcoma|Pazopanib 800 mg (tablets) administered orally once a day
518069|NCT00297258|O1|Outcome|Pazopanib 800 mg - Adipocytic Tumors|Pazopanib 800 mg (tablets) administered orally once a day
518070|NCT00297258|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligram (mg) (tablets) administered orally once a day
518071|NCT00297232|B1|Baseline|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
518072|NCT00297232|P1|Participant Flow|Natalizumab|300 mg intravenous (IV) infusions once every 4 weeks for up to 480 weeks
518073|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
518074|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
518075|NCT00297232|O1|Outcome|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
518076|NCT00297232|E1|Reported Event|Natalizumab|300 mg IV infusions once every 4 weeks for up to 480 weeks
518077|NCT00297167|B1|Baseline|Entire Study Population|Includes participants who received EUR-1008 (APT-1008) in open-label dose titration and stabilization phase; and EUR-1008 (APT-1008) first and placebo first after randomization to study treatment.
518078|NCT00297167|P3|Participant Flow|EUR-1008 (APT-1008) (Open-label)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily at a fixed stabilized dose during open-label normalization period 1 (5 to 14 days) after first double-blind interventional period and during open-label normalization period 2 (7 days) after second double-blind interventional period.
518079|NCT00297167|P2|Participant Flow|EUR-1008 (APT-1008) First, Then Placebo|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first double-blind intervention period followed by placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518080|NCT00297167|P1|Participant Flow|Placebo First, Then EUR-1008 (APT-1008)|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first double-blind intervention period followed by EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (lipase units/kg/day).
518081|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518082|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518083|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518084|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518085|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518086|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518087|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518088|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518089|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518090|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518108|NCT00297115|O2|Outcome|Placebo|once daily
518109|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518110|NCT00297115|O2|Outcome|Placebo|once daily
518091|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518092|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518093|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518094|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518095|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518096|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518097|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518098|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518099|NCT00297167|O2|Outcome|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518100|NCT00297167|O1|Outcome|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule and was given orally daily in the first and second double-blind intervention periods; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be opened and sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. The stabilized dose was not to exceed 10,000 lipase units/kg/day.
518101|NCT00297167|E2|Reported Event|Placebo|Placebo matched to EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment.
518102|NCT00297167|E1|Reported Event|EUR-1008 (APT-1008)|EUR-1008 (APT-1008) microtablets (5000 lipase units) or minitablets (10000, 15000 or 20000 lipase units) contained in a capsule was given orally daily in the first and second double-blind intervention period; at a dose based on investigator's discretion as achieved during dose titration and stabilization period (6 to 9 days). The capsules could be sprinkled on acidic food and half of the established dose was used with snacks. Treatment duration for each double-blind intervention period was 2 days home treatment and 3 to 5 days hospital treatment. Participants received EUR-1008 (APT-1008) microtablets or minitablets contained in a capsule was given orally daily at a fixed stabilized dose for 5 to 14 days during open-label dose normalization period 1 and for 7 days during open-label dose normalization period 2 which was maintained after each double-blind intervention period. The stabilized dose was not to exceed 10,000 lipase units per kilogram body weight per day (units/kg/day).
518103|NCT00297115|B3|Baseline|Total|Total of all reporting groups
518104|NCT00297115|B2|Baseline|Placebo|once daily
518105|NCT00297115|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
518106|NCT00297115|P2|Participant Flow|Placebo|once daily
518107|NCT00297115|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
518113|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518114|NCT00297115|O2|Outcome|Placebo|once daily
518115|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518116|NCT00297115|O2|Outcome|Placebo|once daily
518117|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518118|NCT00297115|O2|Outcome|Placebo|once daily
518119|NCT00297115|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518120|NCT00297115|E2|Reported Event|Placebo|once daily
518121|NCT00297115|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
518122|NCT00297102|B3|Baseline|Total|Total of all reporting groups
518123|NCT00297102|B2|Baseline|Placebo|once daily
518124|NCT00297102|B1|Baseline|Roflumilast|500 mcg, once daily, oral administration in the morning
518125|NCT00297102|P2|Participant Flow|Placebo|once daily
518126|NCT00297102|P1|Participant Flow|Roflumilast|500 mcg, once daily, oral administration in the morning
518127|NCT00297102|O2|Outcome|Placebo|once daily
518128|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518129|NCT00297102|O2|Outcome|Placebo|once daily
518130|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518131|NCT00297102|O2|Outcome|Placebo|once daily
518132|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518133|NCT00297102|O2|Outcome|Placebo|once daily
518134|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518135|NCT00297102|O2|Outcome|Placebo|once daily
518136|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518137|NCT00297102|O2|Outcome|Placebo|once daily
518138|NCT00297102|O1|Outcome|Roflumilast|500 mcg, once daily, oral administration in the morning
518139|NCT00297102|E2|Reported Event|Placebo|once daily
518140|NCT00297102|E1|Reported Event|Roflumilast|500 mcg, once daily, oral administration in the morning
518141|NCT00297037|B3|Baseline|Total|Total of all reporting groups
518142|NCT00297037|B2|Baseline|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518143|NCT00297037|B1|Baseline|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518144|NCT00297037|P2|Participant Flow|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518145|NCT00297037|P1|Participant Flow|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518146|NCT00297037|O2|Outcome|Vehicle|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
518147|NCT00297037|O1|Outcome|Pimecrolimus Cream|During the 6 week double blind phase all patients were randomly assigned to receive either pimecrolimus 1% cream or vehicle twice daily with occlusion on the affected areas.
518148|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
518149|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
518150|NCT00297037|O2|Outcome|Vehicle Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
518151|NCT00297037|O1|Outcome|Pimecrolimus Cream|"During the 6-week double-blind phase, all patients will be randomly assigned to receive either pimecrolimus 1% cream or its vehicle twice daily with occlusion on the affected areas. Topical application of pimecrolimus1% cream for oral erosive lichen planus for a duration of 6 weeks; ¼ gram of cream will be applied to each of the 2 sides of the mouth BID with a 2x2 gauze."
518152|NCT00297037|E2|Reported Event|Vehicle Cream|0.25 grams of vehicle cream (identical in composition and appearance to pimecrolimus 1% cream without active product) applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518153|NCT00297037|E1|Reported Event|Pimecrolimus 1% Cream|0.25 grams of pimecrolimus 1% cream applied to each of the two sides of the mouth twice daily with a 2x2 inch piece of gauze folded in half and placed directly on the lesion for 5 minutes
518154|NCT00296816|B3|Baseline|Total|Total of all reporting groups
518155|NCT00296816|B2|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Non-Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, who did not have a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
518222|NCT00296504|B7|Baseline|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518377|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518156|NCT00296816|B1|Baseline|Oxaliplatin/Docetaxel/Bevacizumab (Measurable Disease)|"Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery, with a measurable disease at baseline.~Measurable disease was defined as having at least one lesion that could be accurately measured in at least one dimension."
518157|NCT00296816|P1|Participant Flow|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518158|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518159|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518160|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518161|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518162|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518163|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518164|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518165|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518166|NCT00296816|O1|Outcome|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518167|NCT00296816|E1|Reported Event|Oxaliplatin/Docetaxel/Bevacizumab|Participants with International Federation of Gynecology and Obstetrics (FIGO) stage IB through IV ovarian, primary peritoneal, or fallopian tube carcinoma treated with Oxaliplatin, Docetaxel, and Bevacizumab - 28 days after initial surgery
518168|NCT00296647|B6|Baseline|Total|Total of all reporting groups
518169|NCT00296647|B5|Baseline|Buproion + Lozenge|
518170|NCT00296647|B4|Baseline|Patch + Lozenge|
518171|NCT00296647|B3|Baseline|Bupropion|
518172|NCT00296647|B2|Baseline|Nicotine Lozenge|
518173|NCT00296647|B1|Baseline|Patch|
518174|NCT00296647|P5|Participant Flow|Buproion + Lozenge|
518175|NCT00296647|P4|Participant Flow|Patch + Lozenge|
518176|NCT00296647|P3|Participant Flow|Bupropion|
518177|NCT00296647|P2|Participant Flow|Nicotine Lozenge|
518178|NCT00296647|P1|Participant Flow|Patch|
518179|NCT00296647|O5|Outcome|Buproion + Lozenge|
518180|NCT00296647|O4|Outcome|Patch + Lozenge|
518181|NCT00296647|O3|Outcome|Bupropion|
518182|NCT00296647|O2|Outcome|Lozenge|
518183|NCT00296647|O1|Outcome|Patch|
518184|NCT00296647|E5|Reported Event|Buproion + Lozenge|
518185|NCT00296647|E4|Reported Event|Patch + Lozenge|
518186|NCT00296647|E3|Reported Event|Bupropion|
518187|NCT00296647|E2|Reported Event|Nicotine Lozenge|
518188|NCT00296647|E1|Reported Event|Patch|
518189|NCT00296517|B3|Baseline|Total|Total of all reporting groups
518190|NCT00296517|B2|Baseline|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518191|NCT00296517|B1|Baseline|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518192|NCT00296517|P2|Participant Flow|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518193|NCT00296517|P1|Participant Flow|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518194|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518195|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518223|NCT00296504|B6|Baseline|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518196|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518197|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518198|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518199|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518200|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518201|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518202|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518203|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518204|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518205|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518206|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518207|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518208|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518209|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518210|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518211|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518212|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518213|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518214|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518215|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518216|NCT00296517|O2|Outcome|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518217|NCT00296517|O1|Outcome|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518218|NCT00296517|E2|Reported Event|Bupropion SR|Subjects with Major Depressive Disorder who were randomized to take 100 mg of Bupropion SR in the morning and placebo in the evening for one week. Week 2 subjects were given 100 mg dose of Bupropion morning and evening. Weeks 3 through 12 received 150 mg dose morning and evening. Week 1 = dose level 1, 100 mg. Week 2 = dose level 2, 200 mg. Weeks 3 - 12 = dose level 3, 300 mg.
518219|NCT00296517|E1|Reported Event|Placebo|Subjects with Major Depressive Disorder who were randomized to placebo to match Bupropion SR during the treatment period.
518220|NCT00296504|B9|Baseline|Total|Total of all reporting groups
518221|NCT00296504|B8|Baseline|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518267|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518224|NCT00296504|B5|Baseline|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518225|NCT00296504|B4|Baseline|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518226|NCT00296504|B3|Baseline|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518227|NCT00296504|B2|Baseline|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518228|NCT00296504|B1|Baseline|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518229|NCT00296504|P9|Participant Flow|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518230|NCT00296504|P8|Participant Flow|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518231|NCT00296504|P7|Participant Flow|Protease Inhibitor (PI)-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518232|NCT00296504|P6|Participant Flow|FPV/RTV Twice Daily (BID) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518233|NCT00296504|P5|Participant Flow|FPV/RTV Once Daily (QD) Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518234|NCT00296504|P4|Participant Flow|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518235|NCT00296504|P3|Participant Flow|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518236|NCT00296504|P2|Participant Flow|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received nelfinavir (NFV) in APV30001
518237|NCT00296504|P1|Participant Flow|FPV Population (APV30001)|Fosamprenavir (FPV) +/- ritonavir (RTV) + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518238|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518239|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518240|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518241|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518242|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518243|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518244|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518245|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518246|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518247|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518248|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518249|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518250|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518251|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518252|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518253|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518254|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518255|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518256|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518257|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518258|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518259|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518260|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518261|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518262|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518263|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518264|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FFPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518265|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518266|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518268|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518269|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518270|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518271|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518272|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518273|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518274|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518275|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518276|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518277|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518278|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518279|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518280|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518281|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518282|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518283|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518284|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518285|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518286|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518287|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518288|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518289|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518290|NCT00296504|O4|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518291|NCT00296504|O3|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518292|NCT00296504|O2|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518293|NCT00296504|O1|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518294|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518295|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518296|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518297|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518298|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518299|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518300|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518301|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518302|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518303|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518304|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518305|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518306|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518307|NCT00296504|O1|Outcome|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518308|NCT00296504|O8|Outcome|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518309|NCT00296504|O7|Outcome|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518310|NCT00296504|O6|Outcome|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518369|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518311|NCT00296504|O5|Outcome|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518312|NCT00296504|O4|Outcome|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518313|NCT00296504|O3|Outcome|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518314|NCT00296504|O2|Outcome|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518315|NCT00296504|O1|Outcome|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518316|NCT00296504|E9|Reported Event|Final Analysis Population (APV30005)|FPV +/- RTV + background regimen in participants who remained in APV30005 after 31 January 2006
518317|NCT00296504|E8|Reported Event|PI-Experienced Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-experienced prior to enrollment in the parent study
518318|NCT00296504|E7|Reported Event|PI-Naïve Population (Other Studies)|FPV +/- RTV + background regimen in participants who were PI-naïve prior to enrollment in the parent study
518319|NCT00296504|E6|Reported Event|FPV/RTV BID Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV BID in APV30003
518320|NCT00296504|E5|Reported Event|FPV/RTV QD Population (APV30003)|FPV +/- RTV + background regimen in participants who had received FPV/RTV QD in APV30003 (no NCT number)
518321|NCT00296504|E4|Reported Event|NFV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received NFV in APV30002
518322|NCT00296504|E3|Reported Event|FPV Population (APV30002)|FPV +/- RTV + background regimen in participants who had received FPV in APV30002 (NCT00009061)
518323|NCT00296504|E2|Reported Event|NFV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received NFV in APV30001
518324|NCT00296504|E1|Reported Event|FPV Population (APV30001)|FPV +/- RTV + background regimen in participants who had received FPV in APV30001 (NCT00008554)
518325|NCT00296491|B5|Baseline|Total|Total of all reporting groups
518326|NCT00296491|B4|Baseline|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
518327|NCT00296491|B3|Baseline|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
518328|NCT00296491|B2|Baseline|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
518329|NCT00296491|B1|Baseline|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
518330|NCT00296491|P4|Participant Flow|Montelukast (MON)|
518331|NCT00296491|P3|Participant Flow|Fluticasone Propionate/Salmeterol (FSC)|
518332|NCT00296491|P2|Participant Flow|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
518333|NCT00296491|P1|Participant Flow|Flut Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Flut Prop = Fluticasone Propionate.
518334|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518335|NCT00296491|O1|Outcome|Fluticasone Propionate + Salmeterol & Montelukast (FSC+MON)|
518336|NCT00296491|O2|Outcome|Montelukast (MON)|
518337|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518338|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518339|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
518340|NCT00296491|O2|Outcome|Montelukast (MON)|
518341|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518342|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518343|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
518344|NCT00296491|O2|Outcome|Montelukast (MON)|
518345|NCT00296491|O1|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518346|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|
518347|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
518348|NCT00296491|O2|Outcome|Fluticasone Prop/Salmeterol/Flut Nasal Spray (FSC+FPANS)|
518349|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol/Montelukast (FSC+MON)|
518350|NCT00296491|O2|Outcome|Fluticasone Propionate/Salmeterol (FSC)|
518351|NCT00296491|O1|Outcome|Flut Prop/Salmeterol/Montelukast (FSC+MON)|
518352|NCT00296491|O2|Outcome|Montelukast (MON)|
518353|NCT00296491|O1|Outcome|Fluticasone Prop/Salmeterol (FSC)|
518354|NCT00296491|E4|Reported Event|Montelukast (MON)|Montelukast (MON) = Placebo DISKUS BID, plus vehicle placebo nasal spray once a day (QD), plus MON (once a day) QD.
518355|NCT00296491|E3|Reported Event|Fluticasone Propionate/Salmeterol (FSC)|Fluticasone Propionate/Salmeterol (FSC) = FSC BID, plus vehicle placebo nasal spray once a day (QD), plus placebo capsule once a day (QD).
518356|NCT00296491|E2|Reported Event|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON)|Fluticasone Propionate/Salmeterol/Montelukast (FSC+MON) = FSC twice a day (BID), plus vehicle placebo nasal spray once a day (QD), plus MON once a day (QD)
518357|NCT00296491|E1|Reported Event|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS)|Fluticasone Prop/Salmeterol/Flut Prop Nasal Spray (FSC+FPANS) = FSC twice a day (BID), plus FPANS (once a day) QD, plus placebo capsule once a day (QD).
518358|NCT00296400|B4|Baseline|Total|Total of all reporting groups
518359|NCT00296400|B3|Baseline|Atorvastatin 80 mg|
518360|NCT00296400|B2|Baseline|Rosuvastatin 40 mg|
518361|NCT00296400|B1|Baseline|Rosuvastatin 10 mg|
518362|NCT00296400|P3|Participant Flow|Atorvastatin 80 mg|
518363|NCT00296400|P2|Participant Flow|Rosuvastatin 40 mg|
518364|NCT00296400|P1|Participant Flow|Rosuvastatin 10 mg|
518365|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518366|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518367|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518368|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518378|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518379|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518380|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518381|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518382|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518383|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518384|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518385|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518386|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518387|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518388|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518389|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518390|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518391|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518392|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518393|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518394|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518395|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518396|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518397|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518398|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518399|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518400|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518401|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518402|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518403|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518404|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518405|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518406|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518407|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518408|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518409|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518410|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518411|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518412|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518413|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518414|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518415|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518416|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518417|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518418|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518419|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518420|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518421|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518422|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518423|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518424|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518425|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518426|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518427|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518428|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518429|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518430|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518431|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518432|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518433|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518434|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518435|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518436|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518437|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518438|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518439|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518440|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518441|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518442|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518443|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518444|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518445|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518446|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518447|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518448|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518449|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518450|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518451|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518452|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518453|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518454|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518455|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518456|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518457|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518458|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518459|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518460|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518461|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518462|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518463|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518464|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518465|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518466|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518467|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518468|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518469|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518470|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518471|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518472|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518473|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518474|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518475|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518476|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518477|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518478|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518479|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518480|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518481|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518482|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518483|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518484|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518485|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518486|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518487|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518488|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518489|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518490|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518491|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518492|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518493|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518494|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518495|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518496|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518497|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518498|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518499|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518500|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518501|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518502|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518503|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518504|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518505|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518506|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518507|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518508|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518509|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518510|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518511|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518512|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518513|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518514|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518515|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518516|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518517|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518518|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518519|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518520|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518521|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518522|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518523|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518524|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518525|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518526|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518527|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518528|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518529|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518530|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518531|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518532|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518533|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518534|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518535|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518536|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518537|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518538|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518539|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518540|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518541|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518542|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518543|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518544|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518545|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518546|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518547|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518548|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518549|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518550|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518551|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518552|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518553|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518554|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518555|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518556|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518557|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518558|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518559|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518560|NCT00296400|O3|Outcome|All Treatments|All Treatments pooled
518561|NCT00296400|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518562|NCT00296400|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518563|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518564|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518565|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518566|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518567|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518568|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518569|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518570|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518571|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518572|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518573|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518574|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518575|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518576|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518577|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518578|NCT00296400|O3|Outcome|Atorvastatin 80 mg|
518579|NCT00296400|O2|Outcome|Rosuvastatin 40 mg|
518580|NCT00296400|O1|Outcome|Rosuvastatin 10 mg|
518581|NCT00296400|E3|Reported Event|Atorvastatin 80 mg|
518582|NCT00296400|E2|Reported Event|Rosuvastatin 40 mg|
518583|NCT00296400|E1|Reported Event|Rosuvastatin 10 mg|
518584|NCT00296374|B4|Baseline|Total|Total of all reporting groups
518585|NCT00296374|B3|Baseline|Atorvastatin 80mg|
518586|NCT00296374|B2|Baseline|Rosuvastatin 40mg|
518587|NCT00296374|B1|Baseline|Rosuvastatin 10mg|
518588|NCT00296374|P3|Participant Flow|Atorvastatin 80mg|
518589|NCT00296374|P2|Participant Flow|Rosuvastatin 40mg|
518590|NCT00296374|P1|Participant Flow|Rosuvastatin 10mg|
518591|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518592|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518593|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518594|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518595|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518596|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518597|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518598|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518599|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518600|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518601|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518602|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518603|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518604|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518605|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518606|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518607|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518608|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518609|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518610|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518611|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518612|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518613|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518614|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518615|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518616|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518617|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518618|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518619|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518620|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518621|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518622|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518623|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518624|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518625|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518626|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518627|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518628|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518629|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518630|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518631|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518632|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518633|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518634|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518635|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518636|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518637|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518638|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518639|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518640|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518641|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518642|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518643|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518644|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518645|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518646|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518647|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518648|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518649|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518650|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518651|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518652|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518653|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518654|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518655|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518656|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518657|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518658|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518659|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518660|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518661|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518662|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518663|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518664|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518665|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518666|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518667|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518668|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518669|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518670|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518671|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518672|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518673|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518674|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518675|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518676|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518677|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518678|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518679|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518680|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518681|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518682|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518683|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518684|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518685|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518686|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518687|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518688|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518689|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518690|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518691|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518692|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518693|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518694|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518695|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518696|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518697|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518698|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518699|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518700|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518701|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518702|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518703|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518704|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518705|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518706|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518707|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518708|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518709|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518710|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518711|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518712|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518713|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518714|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518715|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518716|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518717|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518718|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518719|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518720|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518721|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518722|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518723|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518724|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518725|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518726|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518727|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518728|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518729|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518730|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518731|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518732|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518733|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518734|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518735|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518736|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518737|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518738|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518739|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518740|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518741|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518742|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518743|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518744|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518745|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518746|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518747|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518748|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518749|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518750|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518751|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518752|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518753|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518754|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518755|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518756|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518757|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518758|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518759|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518760|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518761|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518762|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518763|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518764|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518765|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518766|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518767|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518768|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518769|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518770|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518771|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518772|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518773|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518774|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518775|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518776|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518777|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518778|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518779|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518780|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518781|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518782|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518783|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518784|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518785|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518786|NCT00296374|O3|Outcome|All Treatment|All Treatments pooled
518787|NCT00296374|O2|Outcome|Atorvastatin|Atorvastatin Treatment
518788|NCT00296374|O1|Outcome|Rosuvastatin|Rosuvastatin Treatments pooled
518789|NCT00296374|O3|Outcome|Atorvastatin 80 mg|
518790|NCT00296374|O2|Outcome|Rosuvastatin 40 mg|
518791|NCT00296374|O1|Outcome|Rosuvastatin 10 mg|
518792|NCT00296374|O3|Outcome|Atorvastatin 80mg|
518793|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
518794|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
518795|NCT00296374|O3|Outcome|Atorvastatin 80mg|
518796|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
518797|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
518798|NCT00296374|O3|Outcome|Atorvastatin 80mg|
518799|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
518800|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
518801|NCT00296374|O3|Outcome|Atorvastatin 80mg|
518802|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
518803|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
518804|NCT00296374|O3|Outcome|Atorvastatin 80mg|
518805|NCT00296374|O2|Outcome|Rosuvastatin 40mg|
518806|NCT00296374|O1|Outcome|Rosuvastatin 10mg|
518807|NCT00296374|E3|Reported Event|Atorvastatin 80mg|
518808|NCT00296374|E2|Reported Event|Rosuvastatin 40mg|
518809|NCT00296374|E1|Reported Event|Rosuvastatin 10mg|
518810|NCT00296335|B3|Baseline|Total|Total of all reporting groups
518811|NCT00296335|B2|Baseline|Mitomycin, Doxifluridine and Cisplatin|Experimental armMitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
518861|NCT00296192|B5|Baseline|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518862|NCT00296192|B4|Baseline|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518812|NCT00296335|B1|Baseline|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
518813|NCT00296335|P2|Participant Flow|Mitomycin, Doxifluridine and Cisplatin|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
518814|NCT00296335|P1|Participant Flow|Mitomycin and Doxifluridine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
518815|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
518816|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
518817|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
518818|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
518819|NCT00296335|O2|Outcome|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
518820|NCT00296335|O1|Outcome|Mitomycin Plus Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)
518821|NCT00296335|E2|Reported Event|Mitomycin Plus Long-term Fluoropyrimidine and Monthly Cisplati|Experimental arm
518822|NCT00296335|E1|Reported Event|Mitomycin Plus Short-term Fluoropyrimidine|Control arm
518823|NCT00296322|B3|Baseline|Total|Total of all reporting groups
518824|NCT00296322|B2|Baseline|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518825|NCT00296322|B1|Baseline|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
518826|NCT00296322|P2|Participant Flow|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518827|NCT00296322|P1|Participant Flow|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
518828|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518829|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
518830|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518831|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
518832|NCT00296322|O2|Outcome|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518833|NCT00296322|O1|Outcome|Mitomycin and Short-term Fluoropyrimidine|Mitomycin and short-term flouropyrimidine
518834|NCT00296322|E2|Reported Event|iceMFP|Intraperitoneal cisplatin, mitomycin, cisplatin and long-term flouropyrimidine
518835|NCT00296322|E1|Reported Event|Mitomycin and Short-term Fluoropyrimidine|Mitomycin-C 20mg/m2 intravenously (3-6 weeks after surgery) Doxifluridine 460-600mg/m2/day per oral for 3 months (started 4 weeks after surgery)
518836|NCT00296244|B3|Baseline|Total|Total of all reporting groups
518837|NCT00296244|B2|Baseline|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518838|NCT00296244|B1|Baseline|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
518839|NCT00296244|P2|Participant Flow|Study Group|Study group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)
518840|NCT00296244|P1|Participant Flow|Control Group|Control group- basiliximab (Simulect), tacrolimus (Prograf), EC-MPA (Myfortic)with steroids
518841|NCT00296244|O2|Outcome|Study Group|Study group - basiliximab, tacrolimus, EC-MPA
518842|NCT00296244|O1|Outcome|Control Group|Control group- basiliximab, tacrolimus, EC-MPA, steroids
518843|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518844|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
518845|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518846|NCT00296244|O1|Outcome|Control Group|Control group)-basiliximab, tacrolimus, EC-MPA, steroids
518847|NCT00296244|O2|Outcome|Study Group|Study group -basiliximab, tacrolimus, EC-MPA
518848|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
518849|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518850|NCT00296244|O1|Outcome|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
518851|NCT00296244|O2|Outcome|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518852|NCT00296244|O1|Outcome|Control Group|Control group-basiliximab, tacrolimus, EC-MPA, steroids
518853|NCT00296244|E2|Reported Event|Study Group|Study group- basiliximab, tacrolimus, EC-MPA
518854|NCT00296244|E1|Reported Event|Control Group|Control group -basiliximab, tacrolimus, EC-MPA, steroids
518855|NCT00296231|B1|Baseline|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
518856|NCT00296231|P1|Participant Flow|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
518857|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
518858|NCT00296231|O1|Outcome|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
518859|NCT00296231|E1|Reported Event|Nassal High Frequency Ventilation|Stable infants, born at less than 1501 g birthweight, who were at least 7 days of age and requiring nasal continuous positive airway pressure ventilatory support
518860|NCT00296192|B6|Baseline|Total|Total of all reporting groups
518863|NCT00296192|B3|Baseline|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518864|NCT00296192|B2|Baseline|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518865|NCT00296192|B1|Baseline|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518866|NCT00296192|P5|Participant Flow|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518867|NCT00296192|P4|Participant Flow|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518868|NCT00296192|P3|Participant Flow|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518869|NCT00296192|P2|Participant Flow|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518870|NCT00296192|P1|Participant Flow|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518871|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518872|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518873|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518874|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518875|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518876|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518877|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518878|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518879|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518880|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518881|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518882|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518883|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518884|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518885|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518886|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518887|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518888|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518889|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518890|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518891|NCT00296192|O5|Outcome|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518892|NCT00296192|O4|Outcome|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518893|NCT00296192|O3|Outcome|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518894|NCT00296192|O2|Outcome|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518895|NCT00296192|O1|Outcome|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518896|NCT00296192|E5|Reported Event|Rotigotine 4 Puffs|Rotigotine Nasal Spray - 4 puffs (0.99 mg Rotigotine)
518897|NCT00296192|E4|Reported Event|Rotigotine 3 Puffs|Rotigotine Nasal Spray - 3 puffs (0.74 mg Rotigotine)
518898|NCT00296192|E3|Reported Event|Rotigotine 2 Puffs|Rotigotine Nasal Spray - 2 puffs (0.49 mg Rotigotine)
518899|NCT00296192|E2|Reported Event|Rotigotine 1 Puff|Rotigotine Nasal Spray 1 puff (0.25 mg Rotigotine)
518900|NCT00296192|E1|Reported Event|Placebo 1-4 Puffs|Placebo nasal spray 1 - 4 puffs
518901|NCT00295880|B1|Baseline|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518902|NCT00295880|P1|Participant Flow|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518903|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518904|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518905|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518906|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518907|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518908|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518909|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518910|NCT00295880|O1|Outcome|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518911|NCT00295880|E1|Reported Event|Umbilical Cord Blood Transplant Patients|Patients with high-risk hematologic malignancy transplanted with umbilical cord blood via direct marrow injection.
518912|NCT00295854|B4|Baseline|Total|Total of all reporting groups
518913|NCT00295854|B3|Baseline|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518962|NCT00295750|E3|Reported Event|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518914|NCT00295854|B2|Baseline|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518915|NCT00295854|B1|Baseline|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518916|NCT00295854|P3|Participant Flow|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518917|NCT00295854|P2|Participant Flow|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518918|NCT00295854|P1|Participant Flow|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518919|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518920|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518921|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518922|NCT00295854|O3|Outcome|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518923|NCT00295854|O2|Outcome|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518924|NCT00295854|O1|Outcome|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518925|NCT00295854|E3|Reported Event|Placebo|Patients received placebo. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518963|NCT00295750|E2|Reported Event|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
520005|NCT00291694|P2|Participant Flow|Celecoxib|Celecoxib for 12 months
518926|NCT00295854|E2|Reported Event|MN-001 500 mg BID|Patients received MN-001 500 mg BID. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518927|NCT00295854|E1|Reported Event|MN-001 500 mg qd|This group received MN-001 500mg orally (PO)once a day. Patients underwent screening at Visit 1 (≤ 7 days prior to Baseline) and additional eligibility assessments at Visit 2 (Baseline Visit) prior to randomization and after randomization, were scheduled to return at Visit 3 (28 days ± 2 days after Baseline) and at Visit 4 (Week 8, 64 ± 2 days after Baseline) for safety and efficacy assessments. Patients were dispensed study drug at Baseline (Visit 2) and Visit 3. The patients were contacted by telephone at Week 6 (42 days ± 2 days after Baseline) for an interim follow up.
518928|NCT00295750|B4|Baseline|Total|Total of all reporting groups
518929|NCT00295750|B3|Baseline|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518930|NCT00295750|B2|Baseline|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518931|NCT00295750|B1|Baseline|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518932|NCT00295750|P3|Participant Flow|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518933|NCT00295750|P2|Participant Flow|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518934|NCT00295750|P1|Participant Flow|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518935|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518936|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518937|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518938|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518939|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518940|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518941|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518942|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518943|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518944|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518945|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518946|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518947|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518948|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518949|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518950|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518951|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518952|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518953|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518954|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518955|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518956|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518957|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518958|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518959|NCT00295750|O3|Outcome|Leuprolide 7.5 mg|Lupron Depot 7.5 mg IM (in the muscle) every 28 days starting at day 0.
518960|NCT00295750|O2|Outcome|Degarelix 240/80 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 80 mg SC (by injection under the skin) given every 28 days.
518961|NCT00295750|O1|Outcome|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518964|NCT00295750|E1|Reported Event|Degarelix 240/160 mg|Initial dose of 240 mg SC (by injection under the skin) on day 0. Maintenance dose of 160 mg SC (by injection under the skin) given every 28 days.
518965|NCT00295633|B4|Baseline|Total|Total of all reporting groups
518966|NCT00295633|B3|Baseline|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518967|NCT00295633|B2|Baseline|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518968|NCT00295633|B1|Baseline|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518969|NCT00295633|P3|Participant Flow|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518970|NCT00295633|P2|Participant Flow|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518971|NCT00295633|P1|Participant Flow|Saxagliptin 2.5 mg Plus Open-label Thiazolidinedione (TZD)|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518972|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518973|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518974|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518975|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518976|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518977|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518978|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518979|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518980|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518981|NCT00295633|O3|Outcome|Placebo Plus Open-label TZD|The placebo + open-label TZD group includes data from subjects randomized to receive coadministration of blinded placebo plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518982|NCT00295633|O2|Outcome|Saxagliptin 5 mg Plus Open-label TZD|The Saxagliptin 5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 5 mg plus pioglitazone 30 mg or 45 mg once daily (QD), or rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518983|NCT00295633|O1|Outcome|Saxagliptin 2.5 mg Plus Open-label TZD|The Saxagliptin 2.5 mg + Open-Label TZD group includes data from subjects randomized to receive coadministration of blinded Saxagliptin 2.5 mg plus open-label pioglitazone 30 mg or 45 mg once daily (QD), or open label rosiglitazone 4 mg QD, or 8 mg, either QD or in 2 divided doses of 4 mg.
518984|NCT00295633|E3|Reported Event|SAXA 5MG + TZD|
518985|NCT00295633|E2|Reported Event|SAXA 2.5MG + TZD|
518986|NCT00295633|E1|Reported Event|PLA + TZD|
518987|NCT00295503|B1|Baseline|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2, and bevacizumab 15 mg/kg IV every 3 weeks
518988|NCT00295503|P1|Participant Flow|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
518989|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed and Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
518990|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
518991|NCT00295503|O1|Outcome|Cisplatin, Pemetrexed, Bevacizumab|cisplatin 75 mg/m2, pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg IV every 3 weeks
518992|NCT00295503|E1|Reported Event|Experimental Arm|cisplatin, pemetrexed, and bevacizumab
518993|NCT00295490|B5|Baseline|Total|Total of all reporting groups
518994|NCT00295490|B4|Baseline|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
518995|NCT00295490|B3|Baseline|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
518996|NCT00295490|B2|Baseline|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
518997|NCT00295490|B1|Baseline|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
518998|NCT00295490|P4|Participant Flow|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
518999|NCT00295490|P3|Participant Flow|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519000|NCT00295490|P2|Participant Flow|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519001|NCT00295490|P1|Participant Flow|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519002|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519003|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519004|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519005|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519006|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519007|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519008|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519009|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519010|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519011|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519012|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519013|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519014|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519015|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519016|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519017|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519018|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519019|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519020|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519021|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519022|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519023|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519024|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519025|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519026|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519027|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519028|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519029|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519030|NCT00295490|O4|Outcome|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519031|NCT00295490|O3|Outcome|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519032|NCT00295490|O2|Outcome|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519033|NCT00295490|O1|Outcome|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519034|NCT00295490|E4|Reported Event|Placebo|total daily dose was 0mg/day of Devil Claw. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, all were placebo medication. tablets were taken orally.
519035|NCT00295490|E3|Reported Event|1,920mg/d Devil Claw|total daily dose was 1920mg/day of Devil claw taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. All eight tablets contained active Devil Claw; each active tablet containing 240mg Devil Claw .
519036|NCT00295490|E2|Reported Event|960mg/d Devil Claw|total daily dose was 960mg/day taken orally. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 4 were placebo medication and four were active Devil Claw, with each active tablet containing 240mg Devil Claw .
519037|NCT00295490|E1|Reported Event|240mg Devil Claw|Total daily dose was 240mg/day taken orally; this dose is suboptimal. Patients allocated to this treatment arm receiving eight tablets split into two doses to take daily for 16 weeks. of these eight tablets, 7 were placebo medication and one was active Devil Claw (the active tablet contained 240mg Devil Claw).
519038|NCT00295061|B3|Baseline|Total|Total of all reporting groups
519295|NCT00294047|B3|Baseline|Total|Total of all reporting groups
519039|NCT00295061|B2|Baseline|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
519040|NCT00295061|B1|Baseline|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
519041|NCT00295061|P2|Participant Flow|Prolastin / Alpha-1 MP|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
519042|NCT00295061|P1|Participant Flow|Alpha-1 MP / Prolastin|Sequential, blinded treatment periods of Alpha-1 modified process (MP) (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
519043|NCT00295061|O2|Outcome|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
519044|NCT00295061|O1|Outcome|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
519045|NCT00295061|E2|Reported Event|Prolastin|Sequential, blinded treatment periods of Prolastin (active comparator), then crossed-over to Alpha-1 MP (experimental), followed by open-label Alpha-1 MP
519046|NCT00295061|E1|Reported Event|Alpha-1 MP|Sequential, blinded treatment periods of Alpha-1 MP (experimental), then crossed-over to Prolastin (active comparator), followed by open-label Alpha-1 MP
519047|NCT00295009|B7|Baseline|Total|Total of all reporting groups
519048|NCT00295009|B6|Baseline|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
519049|NCT00295009|B5|Baseline|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
519050|NCT00295009|B4|Baseline|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
519051|NCT00295009|B3|Baseline|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519052|NCT00295009|B2|Baseline|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519053|NCT00295009|B1|Baseline|1-Level Fusion|Circumferential fusion at a single lumbar level.
519054|NCT00295009|P6|Participant Flow|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
519055|NCT00295009|P5|Participant Flow|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
519056|NCT00295009|P4|Participant Flow|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
519057|NCT00295009|P3|Participant Flow|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519058|NCT00295009|P2|Participant Flow|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519059|NCT00295009|P1|Participant Flow|1-Level Fusion|Circumferential fusion at a single lumbar level.
519060|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
519061|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
519062|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
519063|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519064|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519065|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
519066|NCT00295009|O6|Outcome|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
519067|NCT00295009|O5|Outcome|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
519068|NCT00295009|O4|Outcome|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
519069|NCT00295009|O3|Outcome|1-Level ProDisc (Non-randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519070|NCT00295009|O2|Outcome|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519071|NCT00295009|O1|Outcome|1-Level Fusion|Circumferential fusion at a single lumbar level.
519072|NCT00295009|E6|Reported Event|2-Level ProDisc (Continued Access)|Non-randomized total disc arthroplasty with the ProDisc device at two spinal lumbar levels. Continued Access patients only followed out to 24 months.
519073|NCT00295009|E5|Reported Event|2-Level ProDisc|Total disc arthroplasty with the ProDisc device at two adjacent lumbar levels.
519074|NCT00295009|E4|Reported Event|2-Level Fusion|Circumferential fusion at two adjacent lumbar levels.
519075|NCT00295009|E3|Reported Event|1-Level ProDisc (Non-Randomized)|Non-randomized total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519076|NCT00295009|E2|Reported Event|1-Level ProDisc|Total disc arthroplasty with the ProDisc device at one spinal lumbar level.
519077|NCT00295009|E1|Reported Event|1-Level Fusion|Circumferential fusion at a single lumbar level.
519078|NCT00294762|B3|Baseline|Total|Total of all reporting groups
519079|NCT00294762|B2|Baseline|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519080|NCT00294762|B1|Baseline|Erlotinib|150 mg erlotinib daily
519081|NCT00294762|P2|Participant Flow|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519082|NCT00294762|P1|Participant Flow|Erlotinib|150 mg erlotinib daily
519458|NCT00293540|E2|Reported Event|B Mid-follicular Surgery|
519459|NCT00293540|E1|Reported Event|A Mid-luteal Surgery|
519083|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519084|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519085|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519086|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519087|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519088|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519089|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519090|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519091|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519092|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519093|NCT00294762|O2|Outcome|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519094|NCT00294762|O1|Outcome|Erlotinib|150 mg erlotinib daily
519095|NCT00294762|E2|Reported Event|Erlotinib + Chemotherapy (Intercalated)|carboplatin AUC 6 on Day 1-21 days, paclitaxel 200 mg/m^2 on Day 1-21 days, erlotinib 150 mg Days 2-15 for 4 cycles then erlotinib 150 mg daily until progression, withdrawal of consent, or unacceptable toxicity
519096|NCT00294762|E1|Reported Event|Erlotinib|150 mg erlotinib daily
519097|NCT00294723|B4|Baseline|Total|Total of all reporting groups
519098|NCT00294723|B3|Baseline|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519099|NCT00294723|B2|Baseline|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519100|NCT00294723|B1|Baseline|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519101|NCT00294723|P3|Participant Flow|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519102|NCT00294723|P2|Participant Flow|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519103|NCT00294723|P1|Participant Flow|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519104|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519105|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519106|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519107|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519108|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519109|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519110|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519111|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519112|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519113|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519114|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519115|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519116|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519117|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519118|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519119|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519120|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519121|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519122|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519123|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519124|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519125|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519126|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519127|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519128|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519129|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519130|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519131|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519132|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519133|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519134|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519135|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519136|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519137|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519138|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519139|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519140|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519141|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519142|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519143|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519144|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519145|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519146|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519460|NCT00293462|B4|Baseline|Total|Total of all reporting groups
519147|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519148|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519149|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519150|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519151|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519152|NCT00294723|O3|Outcome|Glimepiride|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension periods (weeks 52-195)
519153|NCT00294723|O2|Outcome|Lira 1.2|Liraglutide 1.2 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension periods (weeks 52-195)
519154|NCT00294723|O1|Outcome|Lira 1.8|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension periods (weeks 52-195)
519155|NCT00294723|E6|Reported Event|Glimepiride (Weeks 104-195)|Open-label glimepiride 8 mg once daily in the additional extension period (weeks 104-195)
519156|NCT00294723|E5|Reported Event|Lira 1.2 (Weeks 104-195)|Open-label liraglutide 1.2 mg once daily in the additional extension period (weeks 104-195)
519157|NCT00294723|E4|Reported Event|Lira 1.8 (Weeks 104-195)|Open-label liraglutide 1.8 mg once daily in the additional extension period (weeks 104-195)
519158|NCT00294723|E3|Reported Event|Glimepiride (Weeks 0-104)|Glimepiride 8 mg once daily + liraglutide placebo 200 mcl or liraglutide placebo 300 mcl, weeks 0-52 (double-blinded period) and open-label glimepiride 8 mg once daily in the extension period (weeks 52-104)
519159|NCT00294723|E2|Reported Event|Lira 1.2 (Weeks 0-104)|Liraglutide 1.2 mg once daily + glimepiride placebo 8mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.2 mg once daily in the extension period (weeks 52-104)
519160|NCT00294723|E1|Reported Event|Lira 1.8 (Weeks 0-104)|Liraglutide 1.8 mg once daily + glimepiride placebo 8 mg once daily, weeks 0-52 (double-blinded period) and open-label liraglutide 1.8 mg once daily in the extension period (weeks 52-104)
519161|NCT00294658|B3|Baseline|Total|Total of all reporting groups
519162|NCT00294658|B2|Baseline|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519163|NCT00294658|B1|Baseline|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519164|NCT00294658|P2|Participant Flow|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen had been taken every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519165|NCT00294658|P1|Participant Flow|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy had been performed as soon as possible after randomization."
519166|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519167|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519168|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519169|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519170|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519171|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519172|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519173|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519174|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519175|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519176|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519177|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519178|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519179|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
520006|NCT00291694|P1|Participant Flow|Placebo|Placebo for 12 months
519180|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519181|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519182|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519183|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519184|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519185|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519186|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519187|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519188|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519189|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519190|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519191|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519192|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519193|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519194|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519195|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519196|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519197|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519198|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519199|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519200|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519201|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519202|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519203|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519204|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519205|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519206|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519207|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519208|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519209|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519210|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519211|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519212|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
520072|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
519213|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519214|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519215|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519216|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519217|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519218|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519219|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519220|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519221|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519222|NCT00294658|O2|Outcome|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519223|NCT00294658|O1|Outcome|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519224|NCT00294658|E2|Reported Event|Prednisone Alone|"Drug: prednisone alone protocol~prednisone: Prednisone regimen will be every other day, starting at 10mg. The dose will increase by 10mg every 2 days to a target dose."
519225|NCT00294658|E1|Reported Event|Thymectomy Plus Prednisone|"Procedure: Extended Transsternal Thymectomy plus prednisone treatment~thymectomy: The thymectomy will be performed as soon as possible after randomization."
519226|NCT00294645|B3|Baseline|Total|Total of all reporting groups
519227|NCT00294645|B2|Baseline|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519228|NCT00294645|B1|Baseline|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519229|NCT00294645|P2|Participant Flow|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519230|NCT00294645|P1|Participant Flow|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519231|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519232|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519233|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519234|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519235|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519236|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519237|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519238|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519239|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519240|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519241|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519242|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519243|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519244|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519245|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519246|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519247|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519248|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519249|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519250|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519251|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519252|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519253|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519254|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519658|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519255|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519256|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519257|NCT00294645|O2|Outcome|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519258|NCT00294645|O1|Outcome|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519259|NCT00294645|E2|Reported Event|Remote Pacemaker Interrogation|Pacemaker patients followed by remote pacemaker interrogation at 3 month intervals
519260|NCT00294645|E1|Reported Event|Standard of Care With TTM|Pacemaker patients followed by transtelephonic monitoring at 2 month intervals
519261|NCT00294515|B3|Baseline|Total|Total of all reporting groups
519262|NCT00294515|B2|Baseline|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519263|NCT00294515|B1|Baseline|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519264|NCT00294515|P2|Participant Flow|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519265|NCT00294515|P1|Participant Flow|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519266|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519267|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519268|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519269|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519270|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519271|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519272|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519273|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519274|NCT00294515|O2|Outcome|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519275|NCT00294515|O1|Outcome|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519276|NCT00294515|E2|Reported Event|Valganciclovir up to 200 Days|900 mg valganciclovir orally daily for up to 200 days
519277|NCT00294515|E1|Reported Event|Valganciclovir up to 100 Days|900 mg valganciclovir orally daily for up to 100 days
519278|NCT00294398|B3|Baseline|Total|Total of all reporting groups
519279|NCT00294398|B2|Baseline|ICS Prescription + Standard ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
519280|NCT00294398|B1|Baseline|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and are provided a home nebulizer if needed.
519281|NCT00294398|P2|Participant Flow|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects were given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
519282|NCT00294398|P1|Participant Flow|Standard Asthma ED Discharge Therapy|Subjects were instructed to use albuterol as needed (up to every 4 hours), may have been prescribed prednisone and asked to follow-up with their primary doctor in 3-5 days. All viewed an educational video about asthma control and were provided a home nebulizer if needed.
519283|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
519284|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
519285|NCT00294398|O2|Outcome|ICS Prescription + Standard Asthma ED Discharge Therapy:|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
519286|NCT00294398|O1|Outcome|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
519287|NCT00294398|E2|Reported Event|ICS Prescription + Standard Asthma ED Discharge Therapy|"Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:~1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily"
519288|NCT00294398|E1|Reported Event|Standard Asthma ED Discharge Therapy|Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
519289|NCT00294060|B1|Baseline|Pacing Patients|Patients implanted with a pacemaker.
519290|NCT00294060|P1|Participant Flow|Pacing Patients|Patients implanted with a pacemaker.
519291|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
519292|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
519293|NCT00294060|O1|Outcome|Pacing Patients|Patients implanted with a pacemaker.
519294|NCT00294060|E1|Reported Event|Pacing Patients|Patients implanted with a pacemaker.
519296|NCT00294047|B2|Baseline|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519297|NCT00294047|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519298|NCT00294047|P2|Participant Flow|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519299|NCT00294047|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519300|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519301|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519302|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519303|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519304|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519305|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519306|NCT00294047|O2|Outcome|Aluminium Hydroxide|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519307|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519308|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519309|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519310|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519311|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519312|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519313|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519314|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519315|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519316|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519317|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519318|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519319|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519320|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519321|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519322|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519323|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519324|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519325|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519326|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519327|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519328|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519329|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519330|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519331|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519332|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519333|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519334|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519335|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519336|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519337|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519338|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519339|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519340|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519341|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519342|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519343|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519344|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519345|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519346|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519347|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519348|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519349|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519350|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519351|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519352|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519353|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519354|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519355|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519356|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519357|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519358|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519359|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519360|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519361|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519362|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519363|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519364|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519365|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519366|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519367|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519368|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519369|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519370|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519371|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519372|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519373|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519374|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519375|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519376|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519377|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519378|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519379|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519380|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519381|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519382|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519383|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519384|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519385|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519386|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519387|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519388|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519389|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519390|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519391|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519392|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519393|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519394|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519395|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519396|NCT00294047|O2|Outcome|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519397|NCT00294047|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519398|NCT00294047|E2|Reported Event|Aluminium Hydroxide Group|Subjects received 3 doses of Aluminium Hydroxide [Al(OH)3]. Aluminium Hydroxide was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519399|NCT00294047|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ vaccine. Cervarix vaccine was administered intramuscularly into the deltoid region of the non-dominant arm according to a 0, 1, 6 months schedule.
519400|NCT00293813|B4|Baseline|Total|Total of all reporting groups
519401|NCT00293813|B3|Baseline|Placebo|Placebo
519402|NCT00293813|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
519403|NCT00293813|B1|Baseline|Alendronate 70 mg QW|Alendronate 70 mg QW
519404|NCT00293813|P3|Participant Flow|Placebo|Placebo
519405|NCT00293813|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
519406|NCT00293813|P1|Participant Flow|Alendronate 70 mg QW|Alendronate 70 mg QW
519407|NCT00293813|O3|Outcome|Placebo|Placebo
519408|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
519409|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
519410|NCT00293813|O3|Outcome|Placebo|Placebo
519411|NCT00293813|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg Q6M
519412|NCT00293813|O1|Outcome|Alendronate 70 mg QW|Alendronate 70 mg QW
519413|NCT00293813|E3|Reported Event|Denosumab 60 mg Q6M|
519414|NCT00293813|E2|Reported Event|Alendronate 70 mg QW|
519415|NCT00293813|E1|Reported Event|Placebo|
519416|NCT00293722|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519417|NCT00293722|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519418|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519419|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519420|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519421|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
520007|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
519422|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519423|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519424|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519425|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519426|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519427|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519428|NCT00293722|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519429|NCT00293722|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by rheumatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519430|NCT00293709|B1|Baseline|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519431|NCT00293709|P1|Participant Flow|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519432|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519433|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519434|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519435|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519436|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519437|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519438|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519439|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519440|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519441|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519442|NCT00293709|O1|Outcome|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519443|NCT00293709|E1|Reported Event|Participants With Psoriatic Arthritis|Participants with psoriatic arthritis treated by dermatologist who received etanercept (Enbrel) as per local medical practice under conditions of routine daily use, were observed for 1 year.
519444|NCT00293579|B1|Baseline|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519445|NCT00293579|P1|Participant Flow|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519446|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519447|NCT00293579|O1|Outcome|Pemetrexed|"pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles~Pemetrexed: 500 mg/m2 IV every 3 weeks for 6 cycles"
519448|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519449|NCT00293579|O1|Outcome|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519450|NCT00293579|E1|Reported Event|Pemetrexed|pemetrexed 500 mg/m2 administered iv, every three weeks, for 6 cycles
519451|NCT00293540|B3|Baseline|Total|Total of all reporting groups
519452|NCT00293540|B2|Baseline|B Mid-follicular Surgery|
519453|NCT00293540|B1|Baseline|A Mid-luteal Surgery|
519454|NCT00293540|P2|Participant Flow|B Mid-follicular Surgery|
519455|NCT00293540|P1|Participant Flow|A Mid-luteal Surgery|
519456|NCT00293540|O2|Outcome|B Mid-follicular Surgery|
519457|NCT00293540|O1|Outcome|A Mid-luteal Surgery|
519461|NCT00293462|B3|Baseline|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519462|NCT00293462|B2|Baseline|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519463|NCT00293462|B1|Baseline|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519464|NCT00293462|P3|Participant Flow|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm III: Patients were randomized to receive oral salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519465|NCT00293462|P2|Participant Flow|Arm II: Salt & Soda Group (SS)|Arm II: Patients were randomized to receive salt and soda (SS) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving SS treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519466|NCT00293462|P1|Participant Flow|Arm I: GM-CSF Group (GG)|Arm I: Patients were randomized to receive oral sargramostim (GM-CSF) mouthwash as a prevention, holding it in their mouths and swallowing it in intervals over 1 hour once daily. If they develop mucositis, they continue receiving GM-CSF treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519467|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519468|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519469|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519470|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519471|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519472|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519473|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519474|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519475|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519476|NCT00293462|O3|Outcome|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519477|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519478|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519479|NCT00293462|O2|Outcome|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519480|NCT00293462|O1|Outcome|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519481|NCT00293462|E3|Reported Event|Arm III: Salt & Soda Switched to GM-CSF (SG)|Arm II patients are split, with Arm III being switched to GM-CSF when they develop mucositis.
519482|NCT00293462|E2|Reported Event|Arm II: Salt & Soda Group (SS)|Arm II: Patients receive oral salt and soda mouthwash, holding it and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519483|NCT00293462|E1|Reported Event|Arm I: GM-CSF Group (GG)|Arm I: Patients receive oral sargramostim (GM-CSF) mouthwash, holding it in their mouths and swallowing it in intervals over 1 hour once daily. Treatment continues during 6-7 weeks of radiotherapy and until the mucositis heals.
519484|NCT00293384|B1|Baseline|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519506|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519507|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
520008|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
519485|NCT00293384|P1|Participant Flow|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519486|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519487|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519488|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519489|NCT00293384|O1|Outcome|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519490|NCT00293384|E1|Reported Event|Aprepitant, Dexamethasone, Cytoxan & Kytril|"Day 1: 1 mg of Kytril orally or I.V., 10 mg of Dexamethasone orally, and Aprepitant 125 mg orally, 1 hour prior to cyclophosphamide administration.~Cyclophosphamide 4gm/m2 I.V. over 90 - 120 minutes.~Days 2 & 3: Aprepitant 80 mg once daily in the morning.~Aprepitant: Aprepitant 80mg once daily in the morning on days 2 and 3~Cyclophosphamide: Cyclophosphamide 4 gm/m2 I.V. over 90-120 minutes~Dexamethasone: Dexamethasone orally 10 mg 1 hour prior to cyclophosphamide administration.~Granisetron hydrochloride: Kytril 1 mg orally or I.V., 1 hour prior to cyclophosphamide administration."
519491|NCT00293293|B3|Baseline|Total|Total of all reporting groups
519492|NCT00293293|B2|Baseline|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519493|NCT00293293|B1|Baseline|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519494|NCT00293293|P2|Participant Flow|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519495|NCT00293293|P1|Participant Flow|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519496|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519497|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519498|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519499|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519500|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519501|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519502|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519503|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519504|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519505|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519865|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519508|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519509|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519510|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519511|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519512|NCT00293293|O1|Outcome|Chemotherapy Plus CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519513|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519514|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519515|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519516|NCT00293293|O2|Outcome|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519517|NCT00293293|O1|Outcome|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519518|NCT00293293|E2|Reported Event|Chemotherapy + CAM|Patients receiving 6 cycles of a taxane or platinum therapy therapy for ovarian, peritoneal, or fallopian tube cancer with additional complementary alternative medicine - CAM (hypnosis, healing touch and massage therapy).
519519|NCT00293293|E1|Reported Event|Chemotherapy Alone|Patients receiving 6 cycles of a taxane or platinum therapy for ovarian, peritoneal, or fallopian tube cancer by their treating physician.
519520|NCT00293267|B3|Baseline|Total|Total of all reporting groups
519521|NCT00293267|B2|Baseline|Placebo + OBT|
519522|NCT00293267|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
519523|NCT00293267|P2|Participant Flow|Placebo + OBT|
519524|NCT00293267|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
519525|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519526|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519527|NCT00293267|O2|Outcome|Placebo + OBT|
519528|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519529|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519530|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519531|NCT00293267|O2|Outcome|Placebo + OBT|
519532|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519533|NCT00293267|O2|Outcome|Placebo + OBT|
519534|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519535|NCT00293267|O2|Outcome|Placebo + OBT|
519536|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519537|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519538|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519539|NCT00293267|O2|Outcome|Placebo + OBT|
519540|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519541|NCT00293267|O2|Outcome|Placebo + OBT|
519542|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519543|NCT00293267|O2|Outcome|Placebo + OBT|
519544|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519545|NCT00293267|O2|Outcome|Placebo + OBT|
519546|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519547|NCT00293267|O2|Outcome|Placebo + OBT|
519548|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519549|NCT00293267|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519657|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519550|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519551|NCT00293267|O2|Outcome|Placebo + OBT|
519552|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519553|NCT00293267|O2|Outcome|Placebo + OBT|
519554|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519555|NCT00293267|O2|Outcome|Placebo + OBT|
519556|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519557|NCT00293267|O2|Outcome|Placebo + OBT|
519558|NCT00293267|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519559|NCT00293267|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
519560|NCT00293267|E1|Reported Event|Raltegravir 400 mg b.i.d Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
519561|NCT00293254|B3|Baseline|Total|Total of all reporting groups
519562|NCT00293254|B2|Baseline|Placebo + OBT|
519563|NCT00293254|B1|Baseline|Raltegravir 400 mg b.i.d. + OBT|
519564|NCT00293254|P2|Participant Flow|Placebo + OBT|
519565|NCT00293254|P1|Participant Flow|Raltegravir 400 mg b.i.d. + OBT|
519566|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519567|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519568|NCT00293254|O2|Outcome|Placebo + OBT|
519569|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519570|NCT00293254|O2|Outcome|Placebo + OBT|
519571|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519572|NCT00293254|O2|Outcome|Placebo + OBT|
519573|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519574|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519575|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519576|NCT00293254|O2|Outcome|Placebo + OBT|
519577|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519578|NCT00293254|O2|Outcome|Placebo + OBT|
519579|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519580|NCT00293254|O2|Outcome|Placebo + OBT|
519581|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519582|NCT00293254|O2|Outcome|Placebo + OBT|
519583|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519584|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519585|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519586|NCT00293254|O2|Outcome|Placebo + OBT|
519587|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519588|NCT00293254|O2|Outcome|Placebo + OBT|
519589|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519590|NCT00293254|O2|Outcome|Placebo + OBT|
519591|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519592|NCT00293254|O2|Outcome|Placebo + OBT|Placebo plus OBT includes all participants initially randomized to placebo. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants received raltegravir plus OBT until Week 240.
519593|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|Raltegravir 400 mg b.i.d. plus OBT includes all participants initially randomized to raltegravir. Those who did not experience virologic failure by Week 156 may have continued into the open-label phase. During the open-label phase, these participants continued to receive raltegravir plus OBT until Week 240.
519594|NCT00293254|O2|Outcome|Placebo + OBT|
519595|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519596|NCT00293254|O2|Outcome|Placebo + OBT|
519597|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519598|NCT00293254|O2|Outcome|Placebo + OBT|
519599|NCT00293254|O1|Outcome|Raltegravir 400 mg b.i.d. + OBT|
519600|NCT00293254|E2|Reported Event|Placebo Plus OBT|Includes all participants initially randomized to placebo, including those without virologic failure who continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT.
520067|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
519601|NCT00293254|E1|Reported Event|Raltegravir 400 mg b.i.d. Plus OBT|"Includes all participants initially randomized to raltegravir, including those without virologic failure who~continued into the open-label phase at Week 156 and those who entered the OLPVF phase due to virologic failure. During either open-label phase up to Week 240, these participants continued to receive raltegravir 400 mg b.i.d. plus OBT."
519602|NCT00293241|B3|Baseline|Total|Total of all reporting groups
519603|NCT00293241|B2|Baseline|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519604|NCT00293241|B1|Baseline|MVP ON|Managed Ventricular Pacing programmed on
519605|NCT00293241|P2|Participant Flow|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519606|NCT00293241|P1|Participant Flow|MVP ON|Managed Ventricular Pacing programmed on
519607|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519608|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519609|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519610|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519611|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519612|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519613|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519614|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519615|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519616|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519617|NCT00293241|O2|Outcome|MVP OFF|"Managed Ventricular Pacing programmed off: conventional pacing~Managed Ventricular Pacing programmed ON/OFF: Device programming"
519618|NCT00293241|O1|Outcome|MVP ON|"Managed Ventricular Pacing programmed on~Managed Ventricular Pacing programmed ON/OFF: Device programming"
519619|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519620|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519621|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519622|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519623|NCT00293241|O2|Outcome|MVP Off|Managed Ventricular Pacing programmed off: conventional pacing
519624|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519625|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519626|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519627|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519628|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519629|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519630|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519631|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519632|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519633|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519634|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519635|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519636|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519637|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519638|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519639|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519640|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519641|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519642|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519643|NCT00293241|O2|Outcome|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519644|NCT00293241|O1|Outcome|MVP ON|Managed Ventricular Pacing programmed on
519645|NCT00293241|E2|Reported Event|MVP OFF|Managed Ventricular Pacing programmed off: conventional pacing
519646|NCT00293241|E1|Reported Event|MVP ON|Managed Ventricular Pacing programmed on
519647|NCT00293059|B3|Baseline|Total|Total of all reporting groups
519648|NCT00293059|B2|Baseline|Placebo|Matching placebo to be taken orally daily
519649|NCT00293059|B1|Baseline|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519650|NCT00293059|P2|Participant Flow|Placebo|Matching placebo to be taken orally daily
519651|NCT00293059|P1|Participant Flow|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519652|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519653|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519654|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519655|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519656|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
520068|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
519659|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519660|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519661|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519662|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519663|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519664|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519665|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519666|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519667|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519668|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519669|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519670|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519671|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519672|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519673|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519674|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519675|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519676|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519677|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519678|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519679|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519680|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519681|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519682|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519683|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519684|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519685|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519686|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519687|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519688|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519689|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519690|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519691|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519692|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519866|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
520069|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
519693|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519694|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519695|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519696|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519697|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519698|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519699|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519700|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519701|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519702|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519703|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519704|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519705|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519706|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519707|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519708|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519709|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519710|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519711|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519712|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519713|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519714|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519715|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519716|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519717|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519718|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519719|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519720|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519721|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519722|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519723|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519724|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519725|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519726|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519867|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
520070|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
519727|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519728|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519729|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519730|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519731|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519732|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519733|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519734|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519735|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519736|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519737|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519738|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519739|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519740|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519741|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519742|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519743|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519744|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519745|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519746|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519747|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519748|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519749|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519750|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519751|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519752|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519753|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519754|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519755|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519756|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519757|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519758|NCT00293059|O2|Outcome|Placebo|Matching placebo to be taken orally daily
519759|NCT00293059|O1|Outcome|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519760|NCT00293059|E2|Reported Event|Placebo|Matching placebo to be taken orally daily
519868|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519761|NCT00293059|E1|Reported Event|Estradiol Valerate/Dienogest (Natazia, Qlaira, BAY86-5027)|A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo
519762|NCT00291876|B1|Baseline|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519763|NCT00291876|P1|Participant Flow|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519764|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519765|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519766|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519767|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519768|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519769|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519770|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519771|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519772|NCT00291876|O1|Outcome|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519773|NCT00291876|E1|Reported Event|Havrix Group|Subjects who received during the primary study 2 doses of Havrix™ at Day 0 and at Month 12.
519774|NCT00293020|B1|Baseline|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
519775|NCT00293020|P1|Participant Flow|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
519776|NCT00293020|O1|Outcome|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
519777|NCT00293020|E1|Reported Event|Open Label Fentanyl Treatment|BioErodible Muco Adhesive(BEMA) Fentanyl
519778|NCT00292981|B1|Baseline|C1 Esterase Inhibitor|
519779|NCT00292981|P1|Participant Flow|C1 Esterase Inhibitor|
519780|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
519781|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
519782|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
519783|NCT00292981|O1|Outcome|C1 Esterase Inhibitor|
519784|NCT00292981|E1|Reported Event|C1 Esterase Inhibitor|
519785|NCT00292591|B4|Baseline|Total|Total of all reporting groups
519786|NCT00292591|B3|Baseline|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519787|NCT00292591|B2|Baseline|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519788|NCT00292591|B1|Baseline|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519789|NCT00292591|P3|Participant Flow|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519790|NCT00292591|P2|Participant Flow|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519791|NCT00292591|P1|Participant Flow|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519792|NCT00292591|O3|Outcome|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519793|NCT00292591|O2|Outcome|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519794|NCT00292591|O1|Outcome|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519795|NCT00292591|E3|Reported Event|Cholecalciferol 4000 IU|"Experimental group receiving 4000 IU/day cholecalciferol~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519796|NCT00292591|E2|Reported Event|Cholecalciferol 2000 IU|"Experimental group receiving 2000 IU total vitamin D3/day.~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519869|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
520071|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
519797|NCT00292591|E1|Reported Event|Cholecalciferol-400 IU|"Control group receiving 400 IU/day plus 0 IU vitamin D3 as placebo/day~cholecalciferol (vitamin D3): randomized control trial of three vitamin D doses: 400, 2000 and 4000 IU/day~cholecalciferol: comparing vitamin D requirements of pregnant women and their fetuses from 12 weeks' gestation through pregnancy"
519798|NCT00292461|B3|Baseline|Total|Total of all reporting groups
519799|NCT00292461|B2|Baseline|Lamotrigine|once daily orally for 16 weeks
519800|NCT00292461|B1|Baseline|Zonegran|once or twice daily orally for 16 weeks
519801|NCT00292461|P2|Participant Flow|Lamotrigine|once daily orally for 16 weeks
519802|NCT00292461|P1|Participant Flow|Zonegran|once or twice daily orally for 16 weeks
519803|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
519804|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
519805|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
519806|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
519807|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
519808|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
519809|NCT00292461|O2|Outcome|Lamotrigine|once daily orally for 16 weeks
519810|NCT00292461|O1|Outcome|Zonegran|once or twice daily orally for 16 weeks
519811|NCT00292461|E2|Reported Event|Lamotrigine|once daily orally for 16 weeks
519812|NCT00292461|E1|Reported Event|Zonegran|once or twice daily orally for 16 weeks
519813|NCT00292370|B4|Baseline|Total|Total of all reporting groups
519814|NCT00292370|B3|Baseline|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II: Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine in a double-blind fashion."
519815|NCT00292370|B2|Baseline|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II: Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
519816|NCT00292370|B1|Baseline|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
519817|NCT00292370|P3|Participant Flow|Arm 3/OL Paroxetine & Double-blind Quetiapine|"Phase II : Double-blind quetiapine~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of quetiapine for 8 weeks in a double-blind fashion."
519818|NCT00292370|P2|Participant Flow|Arm 2/OL Paroxetine & Double-blind Placebo|"Phase II : Double-blind placebo~In Phase II, participants will continue taking open-label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind fashion."
519819|NCT00292370|P1|Participant Flow|Arm 1/Open-Label (OL) Paroxetine|"Phase I : Open-label Paroxetine~In Phase I, eligible participants will take open-label (OL) paroxetine (up to 60 mg daily) for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS score of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II"
519820|NCT00292370|O2|Outcome|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
519821|NCT00292370|O1|Outcome|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
519822|NCT00292370|E3|Reported Event|Arm 3: OL Paroxetine + DB Quetiapine|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of quetiapine (up to 800 mg daily) for 8 weeks in a double blind fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Quetiapine: Double-blind quetiapine taken with OL paroxetine"
519823|NCT00292370|E2|Reported Event|Arm 2 OL Paroxetine + DB Placebo|"In Phase II, participants will continue taking open label paroxetine and will be randomized to the addition of placebo for 8 weeks in a double-blind (DB) fashion.~Open Label (OL) Paroxetine: Open-label Paroxetine~Placebo: Double-blind placebo taken with OL paroxetine"
519824|NCT00292370|E1|Reported Event|Arm 1: Open Label (OL) Paroxetine|"In Phase I, eligible participants will take open-label (OL) Paroxetine (up to 60 mg) daily for 8 weeks. Participants who are refractory (less than 30% reduction in CAPS scores or a minimum CAPS of 50 at week 8) and have PTSD symptoms of at least moderate severity on CGI-S will be eligible for Phase II.~Open Label (OL) Paroxetine: Open-label Paroxetine"
519825|NCT00292318|B3|Baseline|Total|Total of all reporting groups
519826|NCT00292318|B2|Baseline|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
519827|NCT00292318|B1|Baseline|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
519828|NCT00292318|P2|Participant Flow|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
519829|NCT00292318|P1|Participant Flow|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
520002|NCT00291694|B3|Baseline|Total|Total of all reporting groups
520003|NCT00291694|B2|Baseline|Placebo|Placebo for six months
519830|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
519831|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
519832|NCT00292318|O2|Outcome|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
519833|NCT00292318|O1|Outcome|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
519834|NCT00292318|E2|Reported Event|Study Grp/Biofeedback|"Study group of patients with fecal incontinence which would be given biofeedback therapy and exercises to perform as treatment.~Biofeedback Therapy for Fecal Incontinence: A Randomized Control Study: Patients who have more than one episode per week of fecal incontinence would be enrolled and randomized into either the control group (medical counseling and exercises) or study group (biofeedback therapy, medical counseling, and sphincter exercises) for seven sessions to assist with their medical problem."
519835|NCT00292318|E1|Reported Event|Control|"Control group of patients with fecal incontinence which would be given medical therapy and exercises to perform as treatment.~control group: Medical counseling and ano-sphinctal exercises."
519836|NCT00292227|B3|Baseline|Total|Total of all reporting groups
519837|NCT00292227|B2|Baseline|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519838|NCT00292227|B1|Baseline|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519839|NCT00292227|P3|Participant Flow|Placebo Patch (Infusion: Placebo-Moxifloxacin)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 39.
519840|NCT00292227|P2|Participant Flow|Placebo Patch (Infusion: Moxifloxacin-Placebo)|Placebo Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour on Day 32. Placebo saline solution 250 mL infused over 1 hour on Day 39.
519841|NCT00292227|P1|Participant Flow|Rotigotine Patch (Infusion: Placebo-Placebo)|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule. Placebo saline solution 250 mL infused over 1 hour on Day 32 and on Day 39.
519842|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519843|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519844|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519845|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519846|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519847|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519848|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519849|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519850|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519851|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519852|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519853|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519854|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519855|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519856|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519857|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519858|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519859|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519860|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519861|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519862|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
519863|NCT00292227|O1|Outcome|Moxifloxacin Infusion|Moxifloxacin 400 mg/250 mL iv solution infused over 1 hour once either on Day 32 or on Day 39.
519864|NCT00292227|O2|Outcome|Placebo Infusion|Placebo saline solution 250 mL infused over 1 hour once either on Day 32 or on Day 39.
520004|NCT00291694|B1|Baseline|Celecoxib|Celecoxib for six months
519870|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519871|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519872|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519873|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519874|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519875|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519876|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519877|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519878|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519879|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519880|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519881|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519882|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519883|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519884|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519885|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519886|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519887|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519888|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519889|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519890|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519891|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519892|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519893|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519894|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519895|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519896|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519897|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519898|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519899|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519900|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519901|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519902|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519903|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519904|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519905|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519906|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519907|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519908|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519909|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519910|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519911|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519912|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519913|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519914|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519915|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519916|NCT00292227|O2|Outcome|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519917|NCT00292227|O1|Outcome|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519918|NCT00292227|E2|Reported Event|Placebo Patch|Placebo patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519919|NCT00292227|E1|Reported Event|Rotigotine Patch|Rotigotine Patch applied once daily for a 24 hour period over a total period of 52 days following the prespecified dosing schedule.
519920|NCT00292188|B3|Baseline|Total|Total of all reporting groups
519921|NCT00292188|B2|Baseline|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519922|NCT00292188|B1|Baseline|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519923|NCT00292188|P3|Participant Flow|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519924|NCT00292188|P2|Participant Flow|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519925|NCT00292188|P1|Participant Flow|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
519926|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519927|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519928|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519929|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519930|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519931|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519932|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519933|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519934|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519935|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519936|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519937|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519938|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519939|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519940|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519941|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519942|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519943|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519944|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519945|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519946|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519947|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519948|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519949|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519950|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519951|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519952|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519953|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519954|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519955|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519956|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519957|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519958|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519959|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519960|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519961|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519962|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519963|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519964|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519965|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519966|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519967|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519968|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519969|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519970|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519971|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519972|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519973|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519974|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519975|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519976|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519977|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519978|NCT00292188|O2|Outcome|Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519979|NCT00292188|O1|Outcome|Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519980|NCT00292188|E3|Reported Event|Double-Blind Placebo|Matching placebo through Visit 5. During the 4-week randomized maintenance phase, subjects continued matching placebo until the end of Week 8 (Visit 7) and the 1 week taper phase.
519981|NCT00292188|E2|Reported Event|Double-Blind Pregabalin|"Dose adjustment of 150 to 600 mg/day based on tolerability through Visit 5. During the 4-week randomized maintenance phase, subjects maintained the same dosing regimen achieved at the end of the dose adjustment phase until the end of Week 8 (Visit 7).~At the completion of the dose maintenance phase, subjects tapered off study medication during a 1-week double-blind taper phase (pregabalin 150 to 300 mg/day)."
519982|NCT00292188|E1|Reported Event|Single-Blind Placebo|All subjects received placebo capsules for the 2-week screening period, subjects were then randomized to placebo or pregabalin treatment.
519983|NCT00292162|B3|Baseline|Total|Total of all reporting groups
519984|NCT00292162|B2|Baseline|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519985|NCT00292162|B1|Baseline|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519986|NCT00292162|P2|Participant Flow|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519987|NCT00292162|P1|Participant Flow|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519988|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519989|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519990|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519991|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519992|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519993|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519994|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519995|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519996|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519997|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
519998|NCT00292162|O2|Outcome|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
519999|NCT00292162|O1|Outcome|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
520000|NCT00292162|E2|Reported Event|Radiofrequency Ablation|Patients underwent isolation of the pulmonary veins with radiofrequency ablation. This was performed a maximum of 2 times to try to acheive sinus rhythm. All patients also received background heart failure treatment as per international guidelines.
520001|NCT00292162|E1|Reported Event|Medical Therapy|This consisted of standard treatment of heart failure as per international guidelines. Treatment generally included use of ace-inhibitors (captopril, enalapril, lisinopril, perindopril, ramipril), beta blocker (metoprolol, carvedilol, bisoprolol) and aldosterone antagonists (spironolactone). Obviously actual combination dose and type of drug used dependent on patient comorbidity and tolerance.
520009|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
520010|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
520011|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
520012|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
520013|NCT00291694|O2|Outcome|Placebo|"Matched blinded placebo twice daily for 12 months~placebo: placebo"
520014|NCT00291694|O1|Outcome|Celecoxib|"Oral Celecoxib 400 mg twice daily for 12 months~celecoxib: Celecoxib 400 mg BID"
520015|NCT00291694|O2|Outcome|Placebo|Randomized to receive placebo daily for 12 months
520016|NCT00291694|O1|Outcome|Celecoxib|Randomized to receive celecoxib daily for 12 months
520017|NCT00291694|E2|Reported Event|Placebo|Randomized to receive palcebo daily for 12 months
520018|NCT00291694|E1|Reported Event|Celecoxib|Randomized to receive celecoxib daily for 12 months
520019|NCT00291655|B1|Baseline|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
520020|NCT00291655|P1|Participant Flow|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
520021|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
520022|NCT00291655|O1|Outcome|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
520023|NCT00291655|E1|Reported Event|Levetiracetam Open- Label Treatment|Open-label treatment with Levetiracetam 500 mg oral tablets in monotherapy, 1000 - 3000 mg/day bid over up to 18 months
520024|NCT00291577|B1|Baseline|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520025|NCT00291577|P1|Participant Flow|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520026|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520027|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520028|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520029|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520030|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520031|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520032|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520033|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520034|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520035|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520036|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520037|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520038|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520039|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520040|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520041|NCT00291577|O1|Outcome|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520042|NCT00291577|E1|Reported Event|Sunitinib in Combination With Docetaxel|Sunitinib (SU011248) orally (PO) for 2 weeks every 3 weeks (2 weeks on, then 1 week off = Schedule 2/1) starting on Day 2 (Cycle 2, Day 3 only for those subjects included in the Pharmacokinetic [PK] study); starting dose 37.5 milligrams (mg) daily (QD). Docetaxel (Taxotere) administered Day 1 of each cycle via intravenous (IV) infusion every 3 weeks; starting dose 75 mg/m2.
520043|NCT00291551|B1|Baseline|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520044|NCT00291551|P1|Participant Flow|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520045|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520046|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520047|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520048|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520049|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520050|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
520051|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
520052|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
520053|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520054|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520055|NCT00291551|O1|Outcome|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520056|NCT00291551|O1|Outcome|Non-randomized, Single Arm, Treatment|
520057|NCT00291551|E1|Reported Event|Non-randomized, Single- Arm, Treatment|Paracor Ventricular Support System (PVSS)/HeartNet Ventricular Support System implanted using the Paracor Ventricular Support System (PVSS)/HeartNet Introducer via a left lateral thoracotomy surgical approach.
520058|NCT00291330|B3|Baseline|Total|Total of all reporting groups
520059|NCT00291330|B2|Baseline|Warfarin|PRN to maintain an INR of 2.0-3.0
520060|NCT00291330|B1|Baseline|Dabigatran 150 mg|bid (twice daily) oral
520061|NCT00291330|P2|Participant Flow|Warfarin|PRN to maintain an INR of 2.0-3.0
520062|NCT00291330|P1|Participant Flow|Dabigatran 150 mg|bid (twice daily) oral
520063|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520064|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520065|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520066|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520073|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520074|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520075|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520076|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520077|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520078|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520079|NCT00291330|O2|Outcome|Warfarin|PRN to maintain an INR of 2.0-3.0
520080|NCT00291330|O1|Outcome|Dabigatran 150 mg|bid (twice daily) oral
520081|NCT00291330|E2|Reported Event|Warfarin|PRN to maintain an INR of 2.0-3.0
520082|NCT00291330|E1|Reported Event|Dabigatran 150 mg|bid (twice daily) oral
520083|NCT00291317|B1|Baseline|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
520084|NCT00291317|P1|Participant Flow|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
520085|NCT00291317|O1|Outcome|DEXA|
520086|NCT00291317|O1|Outcome|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
520087|NCT00291317|E1|Reported Event|FES Cycle Exercise|Participants exercised using functional electrical stimulation cycling (FES) using the RT 300 FES cycle (Restorative Therapies, Baltimore, MD). Stimulation rpm (45-50), pulse duration (250 μs), and frequency (33.3 Hz) were fixed. Amplitude ranged from 70-120mA, and average stim ranged from 16.50-29.7 μC. Participants were monitored for autonomic dysreflexia during training. Blood pressure and heart rate were monitored during the initial evaluation and the first session of cycling. Once it was established that there were no adverse physiological responses, ongoing blood pressure and heart rate monitoring did not continue for subsequent sessions. No participant experienced a dysreflexive episode in response to electrical stimulation during this study. Children were scheduled to attend three cycling sessions per week on non-consecutive days for up to 30 minutes (plus a 2 minute warm up and 30 second cool down) per session over a 9 month period.
520088|NCT00291226|B3|Baseline|Total|Total of all reporting groups
520089|NCT00291226|B2|Baseline|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
520090|NCT00291226|B1|Baseline|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
520091|NCT00291226|P2|Participant Flow|Placebo Group|Glycine and placebo dosing group.
520092|NCT00291226|P1|Participant Flow|Glycine|Glycine dosing group.
520093|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
520132|NCT00291161|B1|Baseline|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
520094|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
520095|NCT00291226|O2|Outcome|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
520096|NCT00291226|O1|Outcome|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
520097|NCT00291226|E2|Reported Event|Placebo Group|"Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing. Since earlier product testing by Glytech revealed that a few individuals did not like the somewhat granular texture of the sprinkles, subjects could switch to a second Glytech formulation, consisting of proprietary pre-flavored glycine or sugar powders to be dissolved in 8 ounces of water.~Placebo: Placebo"
520098|NCT00291226|E1|Reported Event|Glycine|"Glycine dosing was fixed at an initial dose of 0.2 g/kg q.h.s for 3 days, then 0.2 g/kg b.i.d. for 4 days, then 0.2 g/kg in the a.m. and 0.4 g/kg in the p.m. for 4 days, and finally 0.4 g/kg b.i.d. Subjects weighing > 100 kg were limited to a total daily dose of 80 g daily.~Glycine and placebo were dispensed under IND 33,515 (DCJ) as one of two proprietary formulations developed by Glytech, Inc. Dosing was initiated with small microencapsulated beads or “sprinkles” (80% glycine by weight), with placebo consisting of microencapsulated sucrose. Recommended administration of the sprinkles was to spoon them onto pudding or applesauce and swallow them with minimal chewing.~Glycine: Glycine 0.4 g/kg bid"
520099|NCT00291187|B5|Baseline|Total|Total of all reporting groups
520100|NCT00291187|B4|Baseline|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
520101|NCT00291187|B3|Baseline|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
520102|NCT00291187|B2|Baseline|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
520103|NCT00291187|B1|Baseline|Placebo|Taken orally 30 minutes prior to bedtime.
520104|NCT00291187|P4|Participant Flow|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
520105|NCT00291187|P3|Participant Flow|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
520106|NCT00291187|P2|Participant Flow|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
520107|NCT00291187|P1|Participant Flow|Placebo|taken orally 30 minutes prior to bedtime
520108|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
520109|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
520110|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
520111|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime
520112|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
520113|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
520114|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
520115|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
520116|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime
520117|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime
520118|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime
520119|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
520120|NCT00291187|O4|Outcome|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
520121|NCT00291187|O3|Outcome|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
520122|NCT00291187|O2|Outcome|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
520123|NCT00291187|O1|Outcome|Placebo|Taken orally 30 minutes prior to bedtime.
520124|NCT00291187|E4|Reported Event|VEC-162 100 mg|100 mg taken orally 30 minutes prior to bedtime.
520125|NCT00291187|E3|Reported Event|VEC-162 50 mg|50 mg taken orally 30 minutes prior to bedtime.
520126|NCT00291187|E2|Reported Event|VEC-162 20 mg|20 mg taken orally 30 minutes prior to bedtime.
520127|NCT00291187|E1|Reported Event|Placebo|Taken orally 30 minutes prior to bedtime.
520128|NCT00291161|B5|Baseline|Total|Total of all reporting groups
520129|NCT00291161|B4|Baseline|Caregivers-Usual Care Comparison Group|Caregivers to veterans with diagnosed dementia receiving educational materials and usual care
520130|NCT00291161|B3|Baseline|Caregivers-PDC Group|Caregivers to veterans with diagnosed dementia receiving the PDC Intervention
520131|NCT00291161|B2|Baseline|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
521175|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520133|NCT00291161|P4|Participant Flow|Caregivers: Usual Care Comparison|Caregivers of the Veterans assigned to the Usual Care Comparison
520134|NCT00291161|P3|Participant Flow|Caregivers: Partners in Dementia Care Intervention|Caregivers for Veterans assigned to the Partners in Dementia Care Intervention
520135|NCT00291161|P2|Participant Flow|Veterans: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
520136|NCT00291161|P1|Participant Flow|Veterans: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
520137|NCT00291161|O2|Outcome|Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
520138|NCT00291161|O1|Outcome|Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
520139|NCT00291161|O2|Outcome|Caregivers: Usual Care Comparison|Patients and caregivers were provided usual care and an educational booklet on dementia
520140|NCT00291161|O1|Outcome|Caregivers: Partners in Dementia Care Intervention|A two-person care coordinator team, one based at the VA and one based at the Alzheimer Association, provided telephone-based support to patients with dementia and their caregivers over a 12-month period. The team addressed medical and nonmedical needs through education, coaching, linkages to needed resources, and mobilization of an informal care network. The program consisted of an upfront assessment, development of care goals and action steps, and ongoing monitoring and intervention by the two coordinators, who communicated with each other regularly.
520141|NCT00291161|E2|Reported Event|Veterans-Usual Care Comparison Group|Veterans with diagnosed dementia receiving educational materials and usual care
520142|NCT00291161|E1|Reported Event|Veterans-PDC Group|Veterans with diagnosed dementia receiving the PDC Intervention
520143|NCT00291135|B1|Baseline|Letrozole|Letrozole, 2.5 mg daily for six months
520144|NCT00291135|P1|Participant Flow|Letrozole|Letrozole, 2.5 mg daily for six months
520145|NCT00291135|O1|Outcome|Letrozole|Letrozole, 2.5 mg daily for six months
520146|NCT00291135|E1|Reported Event|Letrozole|Letrozole, 2.5 mg daily for six months
520147|NCT00289848|B3|Baseline|Total|Total of all reporting groups
520148|NCT00289848|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520149|NCT00289848|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520150|NCT00289848|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520151|NCT00289848|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520152|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520153|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520154|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520155|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520156|NCT00289848|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520157|NCT00289848|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520158|NCT00289848|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
520159|NCT00289848|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
520160|NCT00289783|B3|Baseline|Total|Total of all reporting groups
520161|NCT00289783|B2|Baseline|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520162|NCT00289783|B1|Baseline|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520353|NCT00289757|B1|Baseline|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
521176|NCT00288704|O1|Outcome|Placebo|
520163|NCT00289783|P2|Participant Flow|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520164|NCT00289783|P1|Participant Flow|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520165|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520166|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520167|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520168|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520169|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520170|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520171|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520172|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520173|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520174|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520175|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520472|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
520176|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520177|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520178|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520179|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520180|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520181|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520182|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520183|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520184|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520185|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520186|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520187|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520188|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520473|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
520189|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520190|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520191|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520192|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520193|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520194|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520195|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520196|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520197|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520198|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520199|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520200|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520201|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520381|NCT00289744|E3|Reported Event|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520202|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520203|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520204|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520205|NCT00289783|O2|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520206|NCT00289783|O1|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520207|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520208|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520209|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520210|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520211|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520212|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520213|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520214|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520382|NCT00289744|E2|Reported Event|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
521177|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520215|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520216|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520217|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520218|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520219|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520220|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520221|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520222|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520223|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520224|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520225|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520226|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520227|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520383|NCT00289744|E1|Reported Event|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520228|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520229|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520230|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520231|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520232|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520233|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520234|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520235|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520236|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520237|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520238|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520239|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520240|NCT00289783|O5|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520465|NCT00290732|P5|Participant Flow|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
520241|NCT00289783|O4|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520242|NCT00289783|O3|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520243|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520244|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520245|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520246|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520247|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520248|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520249|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520250|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520251|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520252|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520253|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520466|NCT00290732|P4|Participant Flow|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
520254|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520255|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520256|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520257|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520258|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520259|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520260|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520261|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520262|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520263|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520264|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520265|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520266|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520467|NCT00290732|P3|Participant Flow|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
520267|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520268|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520269|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520270|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520271|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520272|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520273|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520274|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520275|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520276|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520277|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520278|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520279|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520468|NCT00290732|P2|Participant Flow|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
520280|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520281|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520282|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520283|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520284|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520285|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520286|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520287|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520288|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520289|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520290|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520291|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520292|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520469|NCT00290732|P1|Participant Flow|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
521178|NCT00288704|O1|Outcome|Placebo|
520293|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520294|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520295|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520296|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520297|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520298|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520299|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520300|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520301|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520302|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520303|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520304|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520305|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520470|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
521179|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520306|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520307|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520308|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520309|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520310|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520311|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520312|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520313|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520314|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520315|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520316|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520317|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520318|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520471|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
520319|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520320|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520321|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520322|NCT00289783|O2|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520323|NCT00289783|O1|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520324|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520325|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520326|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520327|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520328|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520329|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520330|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520331|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520474|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
521180|NCT00288704|O1|Outcome|Placebo|
520332|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520333|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520334|NCT00289783|O5|Outcome|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520335|NCT00289783|O4|Outcome|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520336|NCT00289783|O3|Outcome|Menhibrix C Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520337|NCT00289783|O2|Outcome|Menhibrix B Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot B co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520338|NCT00289783|O1|Outcome|Menhibrix A Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520339|NCT00289783|E2|Reported Event|ActHIB Group|Subjects were primed with 3 doses of ActHIB co-administered with Pediarix and boosted with 1 dose of PedvaxHIB, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. ActHIB, PedvaxHIB vaccines were administered intramuscularly in the right upper thigh and Pediarix vaccine in the left upper thigh. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520340|NCT00289783|E1|Reported Event|Menhibrix Group|Subjects were primed with 3 doses of Menhibrix vaccine Lot A, B or C co-administered with Pediarix and boosted with 1 dose of Menhibrix vaccine, with co-administration of M-M-R II and Varivax. Subjects received vaccination at approximately 2, 4, 6 months and the fourth dose at 12-15 months of age. Menhibrix and Pediarix vaccines were administered intramuscularly in the right or left upper thigh, respectively. M-M-R II and Varivax vaccines were administered subcutaneously respectively in the upper left arm and the upper right arm.
520341|NCT00289770|B1|Baseline|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520342|NCT00289770|P1|Participant Flow|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520343|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520344|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520345|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520346|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520347|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520348|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520349|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520350|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520351|NCT00289770|O1|Outcome|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
520352|NCT00289770|E1|Reported Event|Twinrix Group|Subjects who were vaccinated with either Lot 1, Lot 2 or Lot 3 of Twinrix in the primary study according to a 0, 1, 6-Month schedule
521181|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520354|NCT00289757|P1|Participant Flow|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520355|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520356|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520357|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520358|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520359|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520360|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520361|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520362|NCT00289757|O1|Outcome|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520363|NCT00289757|E1|Reported Event|Havrix Group|"Subjects who received 2 doses of Havrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Havrix Group for data analyses during the long term follow-up"
520364|NCT00289744|B1|Baseline|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
520365|NCT00289744|P3|Participant Flow|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520366|NCT00289744|P2|Participant Flow|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520367|NCT00289744|P1|Participant Flow|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
520368|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520369|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520370|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520371|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520372|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520373|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520374|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
520375|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520376|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520377|NCT00289744|O2|Outcome|Engerix-B Additional Dose (Pediatric)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now under the age of 16 years and received an additional dose of EngerixTM-B (pediatric dose).
520378|NCT00289744|O1|Outcome|Engerix-B Additional Dose (Adult)|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076). Subjects were now 16 years and above and received an additional dose of EngerixTM-B (adult dose).
520379|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
520380|NCT00289744|O1|Outcome|Twinrix Group|Subjects who received 2 doses (at Day 0 and Month 6) of Twinrix™ in the primary study (study 208127/076)
521182|NCT00288704|O1|Outcome|Placebo|
521183|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520384|NCT00289718|B1|Baseline|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520385|NCT00289718|P1|Participant Flow|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520386|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520387|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520388|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520389|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520390|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520391|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520392|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520393|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520394|NCT00289718|O1|Outcome|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520395|NCT00289718|E1|Reported Event|Twinrix Group|"Subjects who received 2 doses of Twinrix™ (lot A, B or C) in the primary study.~As lot to lot consistency was assessed during the primary study, the 3 groups (lot A, B or C) were pooled into the Twinrix Group for data analyses during the long term follow-up"
520396|NCT00290888|B3|Baseline|Total|Total of all reporting groups
520397|NCT00290888|B2|Baseline|Arthroscopic Rotator Cuff Repair With Acromioplasty|Arthroscopic rotator cuff repair with acromioplasty (ACR-A)
520398|NCT00290888|B1|Baseline|Arthroscopic Rotator Cuff Repair Without Acromioplasty|Arthroscopic rotator cuff repair without acromioplasty (ACR)
520399|NCT00290888|P2|Participant Flow|Arthorscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
520400|NCT00290888|P1|Participant Flow|Arthroscopic Rotator Cuff Repair Without Acromioplasty|"ACR~Acromioplasty"
520401|NCT00290888|O2|Outcome|Arthorscopic Rotator Cuff Repair With Acromioplasty|ACR-A Acromioplasty
520402|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
520403|NCT00290888|O2|Outcome|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
520404|NCT00290888|O1|Outcome|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
520405|NCT00290888|E2|Reported Event|Arthroscopic Rotator Cuff Repair With Acromioplasty|"ACR-A~Acromioplasty"
520406|NCT00290888|E1|Reported Event|Arthroscopic Rotator Cuff Repair Without Acromioplasty|ACR
520407|NCT00290810|B1|Baseline|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520408|NCT00290810|P1|Participant Flow|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520409|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520410|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520411|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520412|NCT00290810|O1|Outcome|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520413|NCT00290810|E1|Reported Event|Treatment (Monoclonal Antibody Therapy)|Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
520414|NCT00290771|B3|Baseline|Total|Total of all reporting groups
520415|NCT00290771|B2|Baseline|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
521184|NCT00288704|O1|Outcome|Placebo|
520416|NCT00290771|B1|Baseline|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520417|NCT00290771|P2|Participant Flow|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520418|NCT00290771|P1|Participant Flow|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520419|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520420|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520421|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520422|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520423|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520424|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520425|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520426|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520427|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520428|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520429|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520430|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520431|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520432|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520433|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520434|NCT00290771|O3|Outcome|All Patients - Imatinib 600 or 1000 mg + Hydroxyurea 1000 mg|Patients took either imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal or imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals.
520435|NCT00290771|O2|Outcome|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520436|NCT00290771|O1|Outcome|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520437|NCT00290771|E2|Reported Event|Imatinib 1000 mg + Hydroxyurea 1000 mg|Patients took imatinib 500 mg (1 imatinib 400 mg tablet and 1 imatinib 100 mg tablet) orally twice daily with the morning and evening meals. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520438|NCT00290771|E1|Reported Event|Imatinib 600 mg + Hydroxyurea 1000 mg|Patients took imatinib 600 mg (1 imatinib 400 mg tablet and 2 imatinib 100 mg tablets) orally once daily with the morning meal. Patients were instructed to swallow the tablets while drinking a large glass of water. In addition to imatinib, patients took hydroxyurea 500 mg orally twice daily with the morning and evening meals. Patients were not allowed concomitant use of enzyme-inducing anticonvulsant drugs.
520439|NCT00290758|B3|Baseline|Total|Total of all reporting groups
520440|NCT00290758|B2|Baseline|Arm B|Patients receive oral placebo once daily for up to 6 months.
520441|NCT00290758|B1|Baseline|Arm A|Patients receive oral genistein once daily for up to 6 months.
520442|NCT00290758|P2|Participant Flow|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
520443|NCT00290758|P1|Participant Flow|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
520444|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520445|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520446|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520447|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520448|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520449|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520450|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
520451|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
520452|NCT00290758|O2|Outcome|Arm II (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520453|NCT00290758|O1|Outcome|Arm I (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520454|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520455|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520456|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients received oral placebo once daily for 6 months
520457|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients received oral genistein once daily for 6 months
520458|NCT00290758|O2|Outcome|Arm B (Placebo)|Patients receive oral placebo once daily for up to 6 months.
520459|NCT00290758|O1|Outcome|Arm A (Genistein)|Patients receive oral genistein once daily for up to 6 months.
520460|NCT00290758|E2|Reported Event|Arm B (Placebo)|Patients take oral placebo once daily for up to 6 months.
520461|NCT00290758|E1|Reported Event|Arm A (Genistein)|Patients take oral genistein once daily for up to 6 months.
520462|NCT00290732|B3|Baseline|Total|Total of all reporting groups
520463|NCT00290732|B2|Baseline|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
520464|NCT00290732|B1|Baseline|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
520599|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520475|NCT00290732|O5|Outcome|Intravenous Arm|Participants receiving standard intravenous administration of pegylated liposomal doxorubicin prior to breast biopsy for drug concentrations.
520476|NCT00290732|O4|Outcome|Intraductal Arm- 10 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 10 mg, prior to conventional surgery for breast cancer.
520477|NCT00290732|O3|Outcome|Intraductal Arm- 5 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 5 mg, prior to conventional surgery for breast cancer.
520478|NCT00290732|O2|Outcome|Intraductal Arm- 2 mg PLD|Participants received intraductal administration of dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD), 2 mg, prior to conventional surgery for breast cancer.
520479|NCT00290732|O1|Outcome|Intraductal Arm- 0 mg PLD|Participants received intraductal administration of dextrose prior to conventional surgery for breast cancer.
520480|NCT00290732|O1|Outcome|Intraductal Arm|Participants received intraductal administration of dextrose or dextrose with pegylated liposomal doxorubicin hydrochloride (or PLD) prior to conventional surgery for breast cancer.
520481|NCT00290732|E5|Reported Event|Intravenous Arm|Note: Adverse events were not collected in the intravenous group/arm; only the concentration of doxorubicin in tissue applied to this group of participants.
520482|NCT00290732|E4|Reported Event|Intraductal Arm- 10 mg PLD|
520483|NCT00290732|E3|Reported Event|Intraductal Arm- 5 mg PLD|
520484|NCT00290732|E2|Reported Event|Intraductal Arm- 2 mg PLD|
520485|NCT00290732|E1|Reported Event|Intraductal Arm- 0 mg PLD|
520486|NCT00290693|B1|Baseline|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
520487|NCT00290693|P1|Participant Flow|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
520488|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
520489|NCT00290693|O1|Outcome|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
520490|NCT00290693|E1|Reported Event|CapTere (Capecitabine + Docetaxel)|"Docetaxel : 30 mg/m2, IV, days 1 and 8 every 3 weeks~Capecitabine : Orally, 1600mg/m2/day given as (800mg/m2 BID), Days 1 through 14 of 21-day cycle"
520491|NCT00290654|B1|Baseline|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
520492|NCT00290654|P1|Participant Flow|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
520493|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520494|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520495|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520496|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520497|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520498|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520499|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520500|NCT00290654|O1|Outcome|Evaluable Patients|Number of patients who had lumpectomy and completed partial breast radiation using a unique balloon-catheter application device.
520501|NCT00290654|E1|Reported Event|MammoSite Treatment Group|Patients with ductal carcinoma in situ (DCIS, a non-invasive form of breast cancer) treated with standard lumpectomy/brachytherapy following by radiation using the MammoSite (FDA approved a balloon-catheter device placed in the lumpectomy cavity through which high dose radiation is delivered). Tamoxifen may be used postoperatively at the discretion of the treating physicians and patient.
520502|NCT00290615|B1|Baseline|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520503|NCT00290615|P1|Participant Flow|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520504|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520745|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520505|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520506|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520507|NCT00290615|O1|Outcome|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520508|NCT00290615|E1|Reported Event|Capecitabine, Oxaliplatin, Bevacizumab, Cetuximab|"Capecitabine - oral administration of 850 mg/m2 every 12 hours on days 1-14. Oxaliplatin - IV administration of 130 mg/m2 over 2 hours on day 1 of a cycle. Bevacizumab- IV administration of 7.5 mg/kg over 30-90 minutes on day 1 of a cycle.~Cetuximab at an initial dose of 400 mg/m2 over 120 minutes and subsequently 250 mg/m2 over 60 minutes on day 1 of a cycle.~Cycles are 21 days."
520509|NCT00290537|B1|Baseline|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
520510|NCT00290537|P2|Participant Flow|Part Two: ZD6474 + Carboplatin + Paclitaxel|Second part of two part treatment, Part One /Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks.
520511|NCT00290537|P1|Participant Flow|Part One: ZD6474|First part of two part treatment, Part One: three 3-week cycles 300 mg of ZD6474 daily. Second part, Part Two: participants randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin AUC 6.0 intravenous (IV) over 15-30 minutes and paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 every 3 weeks
520512|NCT00290537|O2|Outcome|ZD6474 + Carboplatin + Paclitaxel|Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
520513|NCT00290537|O1|Outcome|ZD6474|First part of treatment: three 3-week cycles 300 mg of ZD6474 daily. Second part, patients randomized to receive 300 mg of ZD6474 daily, or 100 mg of ZD6474 daily plus carboplatin and paclitaxel every 3 weeks.
520514|NCT00290537|E1|Reported Event|ZD6474|Part One: three 3-week cycles 300 mg of ZD6474 daily.
520515|NCT00290472|B4|Baseline|Total|Total of all reporting groups
520516|NCT00290472|B3|Baseline|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
520517|NCT00290472|B2|Baseline|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
520518|NCT00290472|B1|Baseline|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
520519|NCT00290472|P3|Participant Flow|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
520520|NCT00290472|P2|Participant Flow|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
520521|NCT00290472|P1|Participant Flow|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
520522|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
520523|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
520524|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
520561|NCT00290238|P1|Participant Flow|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
520525|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
520526|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
520527|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
520528|NCT00290472|O3|Outcome|Chronic Lymphocytic Leukemia|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Chronic lymphocytic leukemia group was defined as patients with histologic subtypes included chronic lymphocytic leukemia, small lymphocytic lymphoma, and other indolent lymphomas.
520529|NCT00290472|O2|Outcome|Follicular Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Follicular lymphoma group was defined as patients with histologic subtypes included follicular lymphoma.
520530|NCT00290472|O1|Outcome|Aggressive B-cell Lymphoma|Patients received Temsirolimus (CCI-779) IV over 30 minutes on days 1,8,15, and 22. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Patients were followed every 8 weeks. Aggressive B-cell lymphoma group was defined as patients with histologic subtypes included diffuse large B-cell lymphoma and transformed follicular lymphoma.
520531|NCT00290472|E1|Reported Event|Temsirolimus|All patients
520532|NCT00290407|B1|Baseline|RITUXIMAB PLUS ORAL Β-GLUCAN|
520533|NCT00290407|P1|Participant Flow|RITUXIMAB PLUS ORAL Β-GLUCAN|
520534|NCT00290407|O1|Outcome|RITUXIMAB PLUS ORAL Β-GLUCAN|
520535|NCT00290407|E1|Reported Event|RITUXIMAB PLUS ORAL Β-GLUCAN|
520536|NCT00290290|B3|Baseline|Total|Total of all reporting groups
520537|NCT00290290|B2|Baseline|Chlorhexidine-alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
520538|NCT00290290|B1|Baseline|Povidone-iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
520539|NCT00290290|P2|Participant Flow|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
520540|NCT00290290|P1|Participant Flow|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
520541|NCT00290290|O2|Outcome|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
520542|NCT00290290|O1|Outcome|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
520543|NCT00290290|E2|Reported Event|Chlorhexidine-Alcohol|Skin at surgical site preoperatively scrubbed with an applicator that contained 2% chlorhexidine gluconate and 70% alcohol
520544|NCT00290290|E1|Reported Event|Povidone-Iodine|Skin at surgical site preoperatively scrubbed then painted with an aqueous solution of 10% povidone-iodine
520545|NCT00290251|B1|Baseline|Eligible Women|All women who consented and were eligible
520546|NCT00290251|P3|Participant Flow|Placebo (PLC)|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
520547|NCT00290251|P2|Participant Flow|Ulipristal Acetate- 10 mg|Women received ulipristal acetate at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
520548|NCT00290251|P1|Participant Flow|Ulipristal Acetate - 20 mg|Women received ulipristal acetate at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
520549|NCT00290251|O2|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
520550|NCT00290251|O1|Outcome|Ulipristal Acetate -10 and 20mg|Women received ulipristal acetate at a daily dose of 10 or 20 mg for 90 - 102 days or three menstrual cycles.
520551|NCT00290251|O3|Outcome|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
520552|NCT00290251|O2|Outcome|Ulipristal Acetate - 10 mg|Women received ulipristal acetate at 10 mg/day for 90 - 102 days or three menstrual cycles.
520553|NCT00290251|O1|Outcome|Ulipristal Acetate -20mg|Women received ulipristal acetate at 20 mg/day for 90 - 102 days or three menstrual cycles.
520554|NCT00290251|E3|Reported Event|Placebo|Women received placebo capsules for 90 - 102 days or three menstrual cycles.
520555|NCT00290251|E2|Reported Event|CDB-2914 - 10 mg|Women received CDB-2914 at a daily dose of 10 mg for 90 - 102 days or three menstrual cycles.
520556|NCT00290251|E1|Reported Event|CDB-2914 -20mg|Women received CDB-2914 at a daily dose of 20 mg for 90 - 102 days or three menstrual cycles.
520557|NCT00290238|B3|Baseline|Total|Total of all reporting groups
520558|NCT00290238|B2|Baseline|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
520559|NCT00290238|B1|Baseline|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
520560|NCT00290238|P2|Participant Flow|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
520598|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
521185|NCT00288704|O2|Outcome|Rilonacept 160 mg|
520562|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
520563|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
520564|NCT00290238|O2|Outcome|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
520565|NCT00290238|O1|Outcome|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
520566|NCT00290238|E2|Reported Event|Transcutaneous Electrical Nerve Stimulation (TENS)|Sham comparator group receiving 10 TENS sessions of 45 minutes each over 11 weeks. Delivered 2 Hz pulse trains as asymmetric, biphasic, square waves with pulse width of 20 microseconds.
520567|NCT00290238|E1|Reported Event|Percutaneous Neuromodulation Therapy (PNT)|Active/test group receiving 10 Percutaneous Neuromodulation Therapy (PNT) sessions of 45 minutes each over 11 weeks. PNT delivers 50 Hz current in a charge-balanced, biphasic, rectangular waveform.
520568|NCT00290199|B3|Baseline|Total|Total of all reporting groups
520569|NCT00290199|B2|Baseline|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520570|NCT00290199|B1|Baseline|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520571|NCT00290199|P2|Participant Flow|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520572|NCT00290199|P1|Participant Flow|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520573|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520574|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520575|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520576|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520577|NCT00290199|O2|Outcome|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520578|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520579|NCT00290199|O2|Outcome|No Foley|No transcervical foley catheter inserted to induce labor
520580|NCT00290199|O1|Outcome|Transcervical Foley|Insertion of a a transcervical foley catherter to induce labor
520581|NCT00290199|E2|Reported Event|No Foley|No insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520582|NCT00290199|E1|Reported Event|Transcervical Foley|Insertion of a foley catheter via the cervix prior to the initiation of induction with oxytocin
520583|NCT00290186|B3|Baseline|Total|Total of all reporting groups
520584|NCT00290186|B2|Baseline|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520585|NCT00290186|B1|Baseline|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520586|NCT00290186|P2|Participant Flow|Hyperbaric Air Treatment (HBA)|"Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~24 Were allocated to HBA 22 Completed all 40 treatments~1 Withdrew prior to treatments~1 Withdrawn during treatments for seizures due to shunt malfunction 22 Completed post treatment testing~1 Study terminated prior to 3-month followup testing 21 Completed 3-month followup testing~1 Did not return for 6-month followup testing~1 Missed 6-month followup testing due to illness not related to study 19 Completed 6-month followup testing 22 Included in pre and post treatment analyses 21 Included in pre, post, and 3-month analyses 19 Included in pre, post, 3-month and 6-month analyses"
520587|NCT00290186|P1|Participant Flow|Hyperbaric Oxygen Treatment (HBO)|"Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~25 Were allocated to HBO 24 Completed all 40 treatments~1 Withdrawn during treatments due to right ear problems and rectal bleeding 24 Completed post treatment testing~Study terminated prior to 3-month followup testing~Did not return for 3- or 6-month followup testing~1 Missed 3-month followup due to illness not related to study but returned for 6-month followup testing 20 Completed 3-month followup testing 20 Completed 6-month testing 24 Included in pre and post treatment analyses 20 Included in pre, post, and 3-month analyses 20 Included in pre, post, 3-month and 6-month analyses"
520588|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520589|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520590|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520591|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520592|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520593|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520594|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520595|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520596|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520597|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520600|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520601|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520602|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520603|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520604|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520605|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520606|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520607|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520608|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520609|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520610|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520611|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520612|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520613|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520614|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520615|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520616|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520617|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520618|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|"14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
520619|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|"100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total~Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total"
520620|NCT00290186|O2|Outcome|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520621|NCT00290186|O1|Outcome|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520622|NCT00290186|E2|Reported Event|Hyperbaric Air Treatment (HBA)|Hyperbaric Air Treatment: 14% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520623|NCT00290186|E1|Reported Event|Hyperbaric Oxygen Treatment (HBO)|Hyperbaric Oxygen Treatment: 100% oxygen at 1.5 ATA for 60 mins, Mon-Fri, 40 treatments total
520624|NCT00289991|B3|Baseline|Total|Total of all reporting groups
520625|NCT00289991|B2|Baseline|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520626|NCT00289991|B1|Baseline|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520627|NCT00289991|P2|Participant Flow|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520628|NCT00289991|P1|Participant Flow|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen intravenous (IV) for first 24 hours: 6 milligrams per kilogram (mg/kg) of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) twice daily (BID) or 200 mg tablet or powder for oral suspension by mouth (PO) BID (subjects greater than or equal to [≥] 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects less than [<] 40 kg body weight).
520629|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520630|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520631|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520632|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520633|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520634|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520635|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520636|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520637|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520638|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520639|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520640|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520641|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520642|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520643|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520644|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520645|NCT00289991|O2|Outcome|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520646|NCT00289991|O1|Outcome|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520647|NCT00289991|E2|Reported Event|Itraconazole|Itraconazole (Sporanox™ Liquid) oral solution 200 mg PO BID. Loading dose as IV formulation on Days 0 and 1.
520648|NCT00289991|E1|Reported Event|Voriconazole|Voriconazole (tablet or powder for oral suspension) loading dose regimen IV for first 24 hours: 6 mg/kg of body weight every 12 hours; maintenance dose (after first 24 hours) 4 mg/kg of body weight (IV) BID or 200 mg tablet or powder for oral suspension PO BID (subjects ≥ 40 kg body weight) or 100 mg tablet or powder for oral suspension twice daily (subjects < 40 kg body weight).
520649|NCT00289978|B4|Baseline|Total|Total of all reporting groups
520650|NCT00289978|B3|Baseline|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520651|NCT00289978|B2|Baseline|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520652|NCT00289978|B1|Baseline|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520653|NCT00289978|P3|Participant Flow|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520654|NCT00289978|P2|Participant Flow|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520655|NCT00289978|P1|Participant Flow|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520656|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520657|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520658|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520659|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520660|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520661|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520662|NCT00289978|O3|Outcome|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520663|NCT00289978|O2|Outcome|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520664|NCT00289978|O1|Outcome|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520665|NCT00289978|E3|Reported Event|Placebo|Patients self-administered a fingolimod placebo capsule orally once daily.
520666|NCT00289978|E2|Reported Event|Fingolimod 0.5 mg|Patients self-administered fingolimod 0.5 mg capsules orally once daily.
520667|NCT00289978|E1|Reported Event|Fingolimod 1.25 mg|Patients self-administered fingolimod 1.25 mg capsules orally once daily.
520668|NCT00289913|B6|Baseline|Total|Total of all reporting groups
520669|NCT00289913|B5|Baseline|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520670|NCT00289913|B4|Baseline|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520671|NCT00289913|B3|Baseline|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520746|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
521186|NCT00288704|O1|Outcome|Placebo|
520672|NCT00289913|B2|Baseline|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520673|NCT00289913|B1|Baseline|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520674|NCT00289913|P5|Participant Flow|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520675|NCT00289913|P4|Participant Flow|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520676|NCT00289913|P3|Participant Flow|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520677|NCT00289913|P2|Participant Flow|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520678|NCT00289913|P1|Participant Flow|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520679|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520680|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520681|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520682|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520683|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520684|NCT00289913|O3|Outcome|VAQTA™/VAQTA™|All participants receiving VAQTA™ alone (from Stage II) on Day 1 and Day 24.
520685|NCT00289913|O2|Outcome|Non-concomitant VAQTA™ Separate From Infanrix™ and PedvaxHIB™|All participants receiving VAQTA™ non-concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 2: PedvaxHIB™ and Infanrix™/VAQTA™/VAQTA™ (Stage 1); and Group 4: PedvaxHIB™/VAQTA™/VAQTA™ (Stage 1).
520686|NCT00289913|O1|Outcome|Concomitant VAQTA™ With Infanrix™ and PedvaxHIB™ or PedvaxHIB™|All participants receiving VAQTA™ Concomitantly with Infanrix™ and PedvaxHIB™ or PedvaxHIB™ were pooled for safety analysis; and includes participants from Groups 1: VAQTA™, PedvaxHIB™ and Infanrix™/VAQTA™ (Stage 1); and Group 3: VAQTA™, PedvaxHIB™/VAQTA™ (Stage 1).
520687|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520688|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520689|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520690|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520691|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520692|NCT00289913|O5|Outcome|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520693|NCT00289913|O4|Outcome|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520694|NCT00289913|O3|Outcome|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520695|NCT00289913|O2|Outcome|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520696|NCT00289913|O1|Outcome|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520697|NCT00289913|E5|Reported Event|VAQTA™/ VAQTA™ (Stage 2)|"Day 1: The first dose of VAQTA™ was administered.~Week 24: The second dose of VAQTA™ was administered."
520698|NCT00289913|E4|Reported Event|PedvaxHIB™/ VAQTA™/ VAQTA™ (Stage I)|"Day 1: PedvaxHIB™ was administered.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520699|NCT00289913|E3|Reported Event|VAQTA™, PedvaxHIB™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose) and PedvaxHIB™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520700|NCT00289913|E2|Reported Event|PedvaxHIB™ and Infanrix™/ VAQTA™/ VAQTA™ (Stage 1)|"Day 1: PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 4: The first dose of VAQTA™ was administered.~Week 28: The second dose of VAQTA™ was administered."
520701|NCT00289913|E1|Reported Event|VAQTA™, PedvaxHIB™ and Infanrix™/ VAQTA™ (Stage 1)|"Day 1: VAQTA™ (first dose), PedvaxHIB™ and Infanrix™ were administered concomitantly at different injection sites.~Week 24: The second dose of VAQTA™ was administered."
520702|NCT00289900|B7|Baseline|Total|Total of all reporting groups
520703|NCT00289900|B6|Baseline|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520704|NCT00289900|B5|Baseline|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520705|NCT00289900|B4|Baseline|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520706|NCT00289900|B3|Baseline|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520707|NCT00289900|B2|Baseline|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520708|NCT00289900|B1|Baseline|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520709|NCT00289900|P6|Participant Flow|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520710|NCT00289900|P5|Participant Flow|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520711|NCT00289900|P4|Participant Flow|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520712|NCT00289900|P3|Participant Flow|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520713|NCT00289900|P2|Participant Flow|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520714|NCT00289900|P1|Participant Flow|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520715|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520716|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520717|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520718|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520719|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520720|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520721|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520722|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520723|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520724|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520725|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520726|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520727|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520728|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520729|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520730|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520731|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520732|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520733|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520734|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520735|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520736|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520737|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520738|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg or MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520739|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520740|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520741|NCT00289900|O2|Outcome|Atorvastatin 10, 20, 40, or 80 mg (Pooled)|Participants who received either atorvastatin 10, 20, 40 or 80 mg (pooled)
520742|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg and MK-0524B 2g/40mg (Pooled)|Participants who received either MK-0524B 2g/20mg or MK-0524B 2g/40mg (pooled)
520743|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520744|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
521187|NCT00288704|E2|Reported Event|Placebo|
520747|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520748|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520749|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520750|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520751|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520752|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520753|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520754|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520755|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520756|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520757|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520758|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520759|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520760|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520761|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520762|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520763|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520764|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520765|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520766|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520767|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520768|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520769|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520770|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520771|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520772|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520773|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520774|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520775|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520776|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520777|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520778|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520779|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520780|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520781|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520782|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520783|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520784|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520785|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520786|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520787|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520788|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520789|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520893|NCT00289458|B1|Baseline|Control Group|Continued with usual activity and care, no intervention
521188|NCT00288704|E1|Reported Event|Rilonacept 160 mg|
520790|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520791|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520792|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520793|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520794|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520795|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520796|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520797|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520798|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520799|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520800|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520801|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520802|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520803|NCT00289900|O6|Outcome|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520804|NCT00289900|O5|Outcome|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520805|NCT00289900|O4|Outcome|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520806|NCT00289900|O3|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520807|NCT00289900|O2|Outcome|MK-0524B 2g/40mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520808|NCT00289900|O1|Outcome|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520809|NCT00289900|E6|Reported Event|Atorvastatin 80 mg|Atorvastatin 80 mg, orally, once daily for 12 weeks
520810|NCT00289900|E5|Reported Event|Atorvastatin 40 mg|Atorvastatin 40 mg, orally, once daily for 12 weeks
520811|NCT00289900|E4|Reported Event|Atorvastatin 20 mg|Atorvastatin 20 mg, orally, once daily for 12 weeks
520812|NCT00289900|E3|Reported Event|Atorvastatin 10 mg|Atorvastatin 10 mg, orally, once daily for 12 weeks
520813|NCT00289900|E2|Reported Event|MK-0524B 2g/40 mg|Co-administration of one tablet of MK-0524A 1g + one tablet of simvastatin 20 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 40 mg for 8 weeks
520814|NCT00289900|E1|Reported Event|MK-0524B 2g/20 mg|Co-administration of one tablet of MK-0524A (Extended Release [ER] niacin/laropiprant [LRPT] 1g + one tablet of simvastatin 10 mg for 4 weeks, then co-administration of two tablets of MK-0524A 1g + simvastatin 20 mg for 8 weeks
520815|NCT00289887|B3|Baseline|Total|Total of all reporting groups
520816|NCT00289887|B2|Baseline|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520817|NCT00289887|B1|Baseline|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520818|NCT00289887|P2|Participant Flow|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520819|NCT00289887|P1|Participant Flow|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520820|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520821|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520822|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520823|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520824|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520825|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520826|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520827|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
521312|NCT00287716|B1|Baseline|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
520828|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520829|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520830|NCT00289887|O2|Outcome|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520831|NCT00289887|O1|Outcome|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520832|NCT00289887|E2|Reported Event|Placebo|Once-daily matching placebo for losartan 50 mg titrated at 4-week intervals to matching placebo for losartan 100 mg, matching placebo for losartan 100 mg/HCTZ 12.5 mg, and matching placebo for losartan 100 mg/HCTZ 25 mg
520833|NCT00289887|E1|Reported Event|Losartan|Once-daily losartan 50 mg titrated at 4-week intervals to losartan 100 mg, losartan 100 mg/Hydrochlorothiazide (HCTZ) 12.5 mg, and losartan 100 mg/HCTZ 25 mg
520834|NCT00289874|B3|Baseline|Total|Total of all reporting groups
520835|NCT00289874|B2|Baseline|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
520836|NCT00289874|B1|Baseline|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
520837|NCT00289874|P2|Participant Flow|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
520838|NCT00289874|P1|Participant Flow|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
520839|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
520840|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
520841|NCT00289874|O2|Outcome|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
520842|NCT00289874|O1|Outcome|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
520843|NCT00289874|E2|Reported Event|Placebo|Montelukast matching-image placebo tablet orally once daily at bedtime for 3 weeks.
520844|NCT00289874|E1|Reported Event|Montelukast 5 mg|Montelukast 5 mg chewable tablet orally once daily at bedtime for 3 weeks.
520845|NCT00289536|B1|Baseline|Treated Participants|Participants who received at least 1 infusion of rAHF-PFM.
520846|NCT00289536|P3|Participant Flow|High Dose|50 IU/kg rAHF-PFM
520847|NCT00289536|P2|Participant Flow|Medium Dose|30 IU/kg rAHF-PFM
520848|NCT00289536|P1|Participant Flow|Low Dose|15 IU/kg rAHF-PFM
520849|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520850|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520851|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520852|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520853|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520854|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520855|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520856|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520857|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520858|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520859|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520860|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520861|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520862|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520863|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520864|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520865|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520866|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520867|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520868|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520869|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520870|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520871|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520872|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520873|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520874|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520875|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520876|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520877|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520878|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520879|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520880|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520881|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520882|NCT00289536|O3|Outcome|High Dose|50 IU/kg rAHF-PFM
520883|NCT00289536|O2|Outcome|Medium Dose|30 IU/kg rAHF-PFM
520884|NCT00289536|O1|Outcome|Low Dose|15 IU/kg rAHF-PFM
520885|NCT00289536|E1|Reported Event|Safety Population (26 Participants)|Participants who received at least 1 infusion of rAHF-PFM
520886|NCT00289471|B1|Baseline|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
520887|NCT00289471|P1|Participant Flow|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
520888|NCT00289471|O1|Outcome|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
520889|NCT00289471|E1|Reported Event|Cognitive Screening|"Cognitive screening~No intervention delivered.: No intervention delivered."
520890|NCT00289458|B4|Baseline|Total|Total of all reporting groups
520891|NCT00289458|B3|Baseline|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520892|NCT00289458|B2|Baseline|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520894|NCT00289458|P3|Participant Flow|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520895|NCT00289458|P2|Participant Flow|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520896|NCT00289458|P1|Participant Flow|Control Group|Continued with usual activity and care, no intervention
520897|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520898|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520899|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520900|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520901|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520902|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520903|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520904|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520905|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520906|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520907|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520908|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520909|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520910|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520911|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520912|NCT00289458|O3|Outcome|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520913|NCT00289458|O2|Outcome|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520914|NCT00289458|O1|Outcome|Control Group|Continued with usual activity and care, no intervention
520915|NCT00289458|E3|Reported Event|Aquatic Exercise Plus Education|Attended twice per week community aquatic exercise class designed to improve strength, balance, and mobility plus an additional educational class once per week to learn about fall risk, and improve confidence in ability to prevent falls.
520916|NCT00289458|E2|Reported Event|Aquatic Exercise|Attended twice per week community aquatic exercise class focussed on improving strength, balance and mobility
520917|NCT00289458|E1|Reported Event|Control Group|Continued with usual activity and care, no intervention
520918|NCT00289341|B3|Baseline|Total|Total of all reporting groups
520919|NCT00289341|B2|Baseline|Placebo|
520920|NCT00289341|B1|Baseline|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
520921|NCT00289341|P2|Participant Flow|Placebo|
520922|NCT00289341|P1|Participant Flow|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
520923|NCT00289341|O1|Outcome|Pre-vs Post-vaccination PSA Slope|
520924|NCT00289341|O1|Outcome|Median Difference, Post-Pre Vaccination|For each antigen group, the difference between the post and pre-vaccination T cell proliferation response was calculated.
520925|NCT00289341|O2|Outcome|Placebo|12 patients receiving vehicle only
520926|NCT00289341|O1|Outcome|Dendritic Cells Pulsed With LNCaP (DC/LNCaP)|12 patients, receiving DC/LNCaP vaccine and the DC/LNCaP-M1 and DC/KLH immunizations over 8 weeks. THE PURPOSE OF THESE 2 ARMS IS TO COMPARE ADVERSE EVENTS (AEs) DURING THE 1ST 8 WKS ONLY.
520927|NCT00289341|E4|Reported Event|Arm 1 and 2 Post-Vaccination Phase|unblinded
520928|NCT00289341|E3|Reported Event|Arm 2 Vaccine Phase|Unblinded
520929|NCT00289341|E2|Reported Event|Arm 1 Vaccine Phase|Single blind
520930|NCT00289341|E1|Reported Event|Arm 2 Placebo Phase|Single-blind
520931|NCT00289289|B4|Baseline|Total|Total of all reporting groups
520932|NCT00289289|B3|Baseline|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
520933|NCT00289289|B2|Baseline|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
520934|NCT00289289|B1|Baseline|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
521313|NCT00287716|P3|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
520935|NCT00289289|P3|Participant Flow|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
520936|NCT00289289|P2|Participant Flow|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
520937|NCT00289289|P1|Participant Flow|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
520938|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
520939|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
520940|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
520941|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
520942|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
520943|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
520944|NCT00289289|O2|Outcome|Intervention Pacing Features Programmed OFF|6-month period subjects had the intervention pacing features programmed OFF. For subjects randomized to the ON-OFF group, this was the 9-15 month post-implant period. For subjects randomized to the OFF-ON group this was the 3-9 month post-implant period.
520945|NCT00289289|O1|Outcome|Intervention Pacing Features Programmed ON|6-month period subjects had the intervention pacing features programmed ON. For subjects randomized to the ON-OFF group, this was the 3-9 month post-implant period. For subjects randomized to the OFF-ON group this was the 9-15 month post-implant period.
520946|NCT00289289|E3|Reported Event|Non-Randomized Group|Subjects exiting prior to the 3-month randomization visit or subjects with no AT/AF burden during the 3-month observation period
520947|NCT00289289|E2|Reported Event|Off-On|Subjects have intervention pacing features turned Off according to the randomization assignment for the first crossover period and then On in the second period.
520948|NCT00289289|E1|Reported Event|On-Off|Subjects have intervention pacing features turned On according to randomization assignment in the first crossover period then Off in the second period.
520949|NCT00289276|B3|Baseline|Total|Total of all reporting groups
520950|NCT00289276|B2|Baseline|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520951|NCT00289276|B1|Baseline|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520952|NCT00289276|P2|Participant Flow|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520953|NCT00289276|P1|Participant Flow|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520954|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520955|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520956|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520957|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520958|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520959|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520960|NCT00289276|O2|Outcome|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520961|NCT00289276|O1|Outcome|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520962|NCT00289276|E2|Reported Event|FAST Expansion|FAST Expansion is the second part of the FAST study. Subjects were enrolled under the CIP Versions 7.0/8.0 and 10/11 from January 2005 to September 2007. The purpose of this part of the FAST study was to expand on the FAST Pivotal study by collecting additional intra-thoracic impedance data to gain more experience with the Fluid Status Trend feature.
520963|NCT00289276|E1|Reported Event|FAST Pivotal|FAST Pivotal was the first part of the FAST study. Subjects were enrolled under the Clinical Investigation Plan (CIP) Versions 2.0/3.0 from November 2003 to November 2004. The purpose of this part of the FAST study was to collect intra-thoracic impedance data required to support the approval of the Fluid Status Trend feature.
520964|NCT00289211|B4|Baseline|Total|Total of all reporting groups
520965|NCT00289211|B3|Baseline|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
520966|NCT00289211|B2|Baseline|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520967|NCT00289211|B1|Baseline|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520968|NCT00289211|P3|Participant Flow|Open-label C1INH-nf Only|Twelve subjects were never randomized but received open-label C1INH-nf for treatment of laryngeal angioedema and/or prior to emergency surgical procedures. These subjects were analyzed for safety only.
520969|NCT00289211|P2|Participant Flow|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520970|NCT00289211|P1|Participant Flow|C1INH-nf|1,000 Units (U) of C1 esterase inhibitor (C1INH-nf) administered intravenously (IV). If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520971|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520972|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520973|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520974|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520975|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520976|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520977|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520978|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520979|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520980|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520981|NCT00289211|O2|Outcome|Placebo|Matching placebo (saline) administered IV. If there was no response to treatment 60 minutes after the first dose, a second placebo (saline) dose could be administered.
520982|NCT00289211|O1|Outcome|C1INH-nf|1,000 U of C1INH-nf administered IV. If there was no response to treatment 60 minutes after the first dose, a second 1,000 U dose could be administered.
520983|NCT00289211|E2|Reported Event|Placebo|
520984|NCT00289211|E1|Reported Event|C1INH-nf|
520985|NCT00289185|B3|Baseline|Total|Total of all reporting groups
520986|NCT00289185|B2|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520987|NCT00289185|B1|Baseline|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520988|NCT00289185|P2|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520989|NCT00289185|P1|Participant Flow|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520990|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520991|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520992|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520993|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520994|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520995|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520996|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520997|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520998|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
520999|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521000|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521001|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521002|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521003|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521004|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521005|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521322|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521006|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521007|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521008|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521009|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521010|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521011|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521012|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521013|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521014|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521015|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521016|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521017|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521018|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521019|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521020|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521021|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521022|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
522316|NCT00285584|O1|Outcome|Bupropion|6 months
521023|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521024|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521025|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
521026|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521027|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521028|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521029|NCT00289185|O2|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521030|NCT00289185|O1|Outcome|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521031|NCT00289185|E2|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of the RTS,S/AS02D vaccine co-administered with the TETRActHib vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The RTS,S/AS02D vaccine was administered in left anterolateral thigh, and the TETRActHib vaccine in the right anterolateral thigh.
521032|NCT00289185|E1|Reported Event|Engerix-B Group|Subjects aged between 6 and 10 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine co-administered with the TETRActHib™ vaccine at Week 0, Week 4 (Month 1) and Week 8 (Month 2). The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
521033|NCT00289133|B3|Baseline|Total|Total of all reporting groups
521034|NCT00289133|B2|Baseline|XLK Poly|"Cross-linked polyethylene tibial insert~total knee arthroplasty: cross-linked polyethylene tibial insert"
521035|NCT00289133|B1|Baseline|GVF Poly|"Gamma Vacuum Foil polyethylene tibial insert~total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert"
521036|NCT00289133|P2|Participant Flow|XLK Poly|Cross-linked polyethylene tibial component
521037|NCT00289133|P1|Participant Flow|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
521038|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521039|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521040|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521041|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521042|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521043|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521044|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521045|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521046|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521047|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521048|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521049|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521050|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene tibial component
521051|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
521052|NCT00289133|O2|Outcome|XLK Poly|Cross-linked polyethylene
521053|NCT00289133|O1|Outcome|GVF Poly|Gamma Vacuum Foil polyethylene
521054|NCT00289133|O2|Outcome|XLK Poly|"Cross-linked polyethylene tibial insert~total knee arthroplasty: cross-linked polyethylene tibial insert"
521055|NCT00289133|O1|Outcome|GVF Poly|"Gamma Vacuum Foil polyethylene tibial insert~total knee arthroplasty: Gamma Vacuum Foil polyethylene tibial insert"
521056|NCT00289133|E2|Reported Event|XLK Poly|Cross-linked polyethylene tibial component
521057|NCT00289133|E1|Reported Event|GVF Poly|Gamma Vacuum Foil polyethylene tibial component
521058|NCT00289120|B1|Baseline|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a 3-week wash out period before subjects enter phase 2 of the study.~Phase 2: Subjects will be given 500 cc of deionized water beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
530485|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
521059|NCT00289120|P1|Participant Flow|Cola First, Then Water|"Phase 1: Subjects will be given 500cc of Cola beverage twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks wash-out period before patients entere phase 2 of thre study.~Phase 2: Subjects will be given 500cc of deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet."
521060|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521061|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521062|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521063|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521064|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521065|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521066|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521067|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521068|NCT00289120|O2|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521069|NCT00289120|O1|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521070|NCT00289120|O2|Outcome|Water|participants ingested 500 mL of deionized water twice daily, with breakfast and dinner.
521071|NCT00289120|O1|Outcome|Cola|they ingested 500 mL of cola (regular Publix brand©) twice daily, with breakfast and dinner.
521072|NCT00289120|E2|Reported Event|Deionized Water Drinking Phase|"Subjects were given 500cc of regular deionized water twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~No adverse event reported."
521073|NCT00289120|E1|Reported Event|Cola Beverage Phase|"Subjects were given 500cc of Cola twice daily to be ingested with breakfast and dinner for six days while on a metabolic diet.~There will be a three weeks interval (wash out period) before crossover to the other treatment arm.~No adverse event reported."
521074|NCT00289107|B3|Baseline|Total|Total of all reporting groups
521075|NCT00289107|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521076|NCT00289107|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521077|NCT00289107|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521078|NCT00289107|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521079|NCT00289107|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521080|NCT00289107|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521081|NCT00289107|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521082|NCT00289107|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521083|NCT00289094|B3|Baseline|Total|Total of all reporting groups
521084|NCT00289094|B2|Baseline|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521085|NCT00289094|B1|Baseline|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521086|NCT00289094|P2|Participant Flow|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521087|NCT00289094|P1|Participant Flow|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521088|NCT00289094|O2|Outcome|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521089|NCT00289094|O1|Outcome|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521090|NCT00289094|E2|Reported Event|Fixed Bearing|P.F.C.® Sigma™ Fixed Cruciate Retaining Knee System implant has a modular polyethylene insert that is intraoperatively locked into position on the metal tibial base.
521091|NCT00289094|E1|Reported Event|Rotating Platform|P.F.C.® Sigma™ Rotating Platform (RP) Cruciate Retaining Knee System has a modular polyethylene insert that is free to rotate around a central pivot point during knee motion.
521092|NCT00289016|B1|Baseline|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521314|NCT00287716|P2|Participant Flow|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521321|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521093|NCT00289016|P1|Participant Flow|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521094|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521095|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521096|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521097|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521098|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521099|NCT00289016|O1|Outcome|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521100|NCT00289016|E1|Reported Event|Talimogene Laherparepvec|Participants received talimogene laherparepvec at an initial dose of 10⁶ plaque forming units (PFU)/mL injected into 1 or more tumors with maximum total volume of 4 mL (up to 2 mL per tumor). Subsequent doses of talimogene laherparepvec at 10⁸ PFU/mL began 3 weeks after the first dose and were administered every 2 weeks for up to 15 weeks. After the initial 8 doses, if indications of biological activity were observed, treatment could continue for up to 16 additional doses.
521101|NCT00288912|B4|Baseline|Total|Total of all reporting groups
521102|NCT00288912|B3|Baseline|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521103|NCT00288912|B2|Baseline|Arm 2|Usual Medical Care
521104|NCT00288912|B1|Baseline|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521105|NCT00288912|P3|Participant Flow|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521106|NCT00288912|P2|Participant Flow|Arm 2|Usual Medical Care
521107|NCT00288912|P1|Participant Flow|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521108|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521109|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
521110|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521111|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521112|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
521113|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521315|NCT00287716|P1|Participant Flow|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521316|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521114|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521115|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
521116|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521117|NCT00288912|O3|Outcome|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521118|NCT00288912|O2|Outcome|Arm 2|Usual Medical Care
521119|NCT00288912|O1|Outcome|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521120|NCT00288912|E3|Reported Event|Arm 3|"Osteoarthritis Self-Management~Osteoarthritis Self-Management: 12-month intervention consisting of monthly phone calls about topics related to self-care for osteoarthritis. Also includes written educational materials on these topics. Participants set goals and action plans, with assistance from health educator, about managing their osteoarthritis."
521121|NCT00288912|E2|Reported Event|Arm 2|Usual Medical Care
521122|NCT00288912|E1|Reported Event|Arm 1|"Health Education Intervention~Health Education: 12-month intervention consisting of monthly phone calls about common health conditions and screening. Also includes written educational materials on these topics."
521123|NCT00288886|B3|Baseline|Total|Total of all reporting groups
521124|NCT00288886|B2|Baseline|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521125|NCT00288886|B1|Baseline|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521126|NCT00288886|P2|Participant Flow|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521127|NCT00288886|P1|Participant Flow|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521128|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521129|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521162|NCT00288704|P2|Participant Flow|Rilonacept 160 mg|"If assigned, subjects received rilonacept 160 mg during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). Note: Between weeks 6 and 15 (Parts A and B), all subjects received rilonacept 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week. At baseline (week 0) subjects receive a loading dose of rilonacept 320 mg."
521163|NCT00288704|P1|Participant Flow|Placebo|If assigned, subjects received Placebo during 1) the first 6 weeks of the study (Part A) or 2) during the randomized withdrawal period from weeks 15-24 (Part B). No subject received Placebo during the open-label extension (after week 24). The drug is administered subcutaneously on a weekly basis.
521164|NCT00288704|O1|Outcome|Rilonacept 160 mg|
521130|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521131|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521132|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521133|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521134|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521135|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521136|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521137|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521138|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521139|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521165|NCT00288704|O1|Outcome|Rilonacept 160 mg|
521166|NCT00288704|O1|Outcome|Rilonacept 160 mg|
521167|NCT00288704|O2|Outcome|Rilonacept 160 mg|
521168|NCT00288704|O1|Outcome|Placebo|
521140|NCT00288886|O2|Outcome|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521141|NCT00288886|O1|Outcome|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521142|NCT00288886|E2|Reported Event|Contracts, Prompts and Reinforcement (CPR)|"Contracting, Prompting & Reinforcing Abstinence & Attendance: Contingent reinforcement of abstinence and prompting of AA/NA attendance~CPR participants received the STX aftercare orientation except they were also provided with the contracting intervention during the orientation sessions, as well as the prompting and reinforcement components of the intervention.~Contracting. Participant's completed a behavioral contract for continuing care participation that took approximately 20 minutes to complete during their final 4 days in initial treatment and after 9 weeks of participation in continuing care.~Prompting. CPR participants received prompts (mailed appointment cards, telephone reminders) to attend all of their aftercare appointments and AA/NA meetings, and following missed aftercare sessions for 1 year (or until discharged from treatment).~Reinforcement. CPR participants received social reinforcement (certificates, honor roll) for attending group therapy."
521143|NCT00288886|E1|Reported Event|Standard Treatment (STX)|"Control condition: Routine residential treatment and orientation to continuing care.~An addiction therapist from the participants' treatment program met with each participant for an individual aftercare orientation session during the final 4 days of the initial treatment program and again during the ninth week of aftercare. Individuals were also encouraged to get an AA or NA sponsor during this session."
521144|NCT00288860|B3|Baseline|Total|Total of all reporting groups
521145|NCT00288860|B2|Baseline|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
521146|NCT00288860|B1|Baseline|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
521147|NCT00288860|P2|Participant Flow|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
521148|NCT00288860|P1|Participant Flow|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
521149|NCT00288860|O2|Outcome|Treatment-As-Usual|"Mental health Treatment As Usual, potentially including case management, pharmacotherapy, and individual and/or group psychotherapy.~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
521150|NCT00288860|O1|Outcome|Telephone Monitoring|"Biweekly monitoring and support by telephone (up to 6 calls over 3 months) as augmentation to mental health care as usual.~Telephone monitoring: Three months of biweekly telephone monitoring and support~TAU: Outpatient mental health Treatment As Usual (psychotherapy and/or medications)"
521151|NCT00288860|O2|Outcome|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
521152|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
521153|NCT00288860|O2|Outcome|Treatment as Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
521154|NCT00288860|O1|Outcome|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
521155|NCT00288860|E2|Reported Event|Treatment-As-Usual|"Treatment as usual~Treatment as Usual Control: Usual outpatient mental health care (psychotherapy and/or medications)"
521156|NCT00288860|E1|Reported Event|Telephone Monitoring|"Telephone monitoring as augmentation to treatment as usual~Telephone case monitoring: Three months of biweekly telephone monitoring and support in addition to usual outpatient mental health care (psychotherapy and/or medications)"
521157|NCT00288704|B4|Baseline|Total|Total of all reporting groups
521158|NCT00288704|B3|Baseline|Open-Label Rilonacept 160 mg|57 new subjects entered the study directly into the OLE. This was not part of the double blind or randomized withdrawal portion of the results. The 44 subjects who completed Parts A and B were not included in this category for baseline characteristics. Pediatric subjects , age 7 or older, received rilonacept dosed 2.2 mg/kg weekly up to 160 mg during the OLE.
521159|NCT00288704|B2|Baseline|Rilonacept 160 mg|
521160|NCT00288704|B1|Baseline|Placebo|
521161|NCT00288704|P3|Participant Flow|Open-Label Extension (OLE) Rilonacept 160 mg|"After week 24 of study, all subjects received weekly injections of rilonacept 160 mg until the end of the study. This was not part of the double blind (Part A) or randomized withdrawal (Part B) portion of the results. Pediatric subjects received rilonacept dosed 2.2 mg/kg weekly up to 160 mg.~Study drug is administered as a 2.0 mL subcutaneous injection once a week."
521169|NCT00288704|O2|Outcome|Rilonacept 160 mg|
521170|NCT00288704|O1|Outcome|Placebo|
521171|NCT00288704|O2|Outcome|Rilonacept 160 mg|
521172|NCT00288704|O1|Outcome|Placebo|
521173|NCT00288704|O2|Outcome|Rilonacept 160 mg|
521174|NCT00288704|O1|Outcome|Placebo|
521189|NCT00288639|B1|Baseline|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521190|NCT00288639|P1|Participant Flow|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521191|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521192|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521193|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521194|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521195|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521196|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521197|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521198|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521199|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521200|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521201|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521202|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521203|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521317|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521204|NCT00288639|O1|Outcome|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521205|NCT00288639|E1|Reported Event|Pregabalin|Pregabalin treatment, given as 2 divided doses, was initiated at a dose of 150 mg/day (75 mg BID). Then, based on individual subject response and tolerability, the dosage could have been increased to 300 mg/day after 1 week. The dosage could have been incrementally increased further to 600 mg/day after an additional week. After 9 weeks of treatment, the optimal dose of pregabalin was to be maintained for 3 months (12 week treatment observation period).
521206|NCT00288600|B3|Baseline|Total|Total of all reporting groups
521207|NCT00288600|B2|Baseline|Control Group- Normal Saline|"Normal Saline solution and Phototherapy~Normal saline solution: Normal saline solution 10 ml/Kg"
521208|NCT00288600|B1|Baseline|Experimental Group - Immunoglobulin|"Intravenous Immunoglobulin and Phototherapy~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
521209|NCT00288600|P2|Participant Flow|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
521210|NCT00288600|P1|Participant Flow|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
521211|NCT00288600|O2|Outcome|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
521212|NCT00288600|O1|Outcome|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
521213|NCT00288600|E2|Reported Event|Control Group|"Normal Saline solution~Normal saline solution: Normal saline solution 10 ml/Kg"
521214|NCT00288600|E1|Reported Event|Experimental Group|"Intravenous Immunoglobulin~Intravenous Immunoglobulin: Intravenous Immunoglobulin"
521215|NCT00288587|B3|Baseline|Total|Total of all reporting groups
521216|NCT00288587|B2|Baseline|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521217|NCT00288587|B1|Baseline|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521218|NCT00288587|P2|Participant Flow|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521219|NCT00288587|P1|Participant Flow|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521220|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521221|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521222|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521223|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521224|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521225|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521226|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521227|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521228|NCT00288587|O2|Outcome|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521229|NCT00288587|O1|Outcome|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521230|NCT00288587|E2|Reported Event|Usual & Customary Care|Patients treated with conventional diuretic therapy upon hospital admission for the treatment of decompensated heart failure.
521231|NCT00288587|E1|Reported Event|Ultrafiltration|Patients treated with Extracorporeal Ultrafiltration upon hospital admission for treatment of decompensated heart failure.
521232|NCT00288574|B3|Baseline|Total|Total of all reporting groups
521233|NCT00288574|B2|Baseline|Placebo|Placebo group
521234|NCT00288574|B1|Baseline|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
521235|NCT00288574|P2|Participant Flow|Placebo|Placebo group
521236|NCT00288574|P1|Participant Flow|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
521237|NCT00288574|O2|Outcome|Placebo|Placebo group
521238|NCT00288574|O1|Outcome|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
521239|NCT00288574|E2|Reported Event|Placebo|Placebo Medication
521240|NCT00288574|E1|Reported Event|Fluoxetine|"fluoxetine up to 80 mg per day~Fluoxetine"
521241|NCT00288509|B1|Baseline|Dysport|250-1000 units
521242|NCT00288509|P1|Participant Flow|Dysport|250-1000 units
521243|NCT00288509|O1|Outcome|Dysport|250-1000 units
521244|NCT00288509|O1|Outcome|Dysport|250-1000 units
521245|NCT00288509|O1|Outcome|Dysport|250-1000 units
521246|NCT00288509|O1|Outcome|Dysport|250-1000 units
521247|NCT00288509|E1|Reported Event|Dysport|250-1000 units
521248|NCT00288080|B3|Baseline|Total|Total of all reporting groups
521249|NCT00288080|B2|Baseline|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521318|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521250|NCT00288080|B1|Baseline|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521251|NCT00288080|P2|Participant Flow|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521252|NCT00288080|P1|Participant Flow|Androgen Suppression + Radiation Therapy (RT)|Androgen suppression (AS; luteinizing hormone-releasing hormone (LHRH) agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521253|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521254|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521255|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521256|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521257|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521258|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521259|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521260|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521261|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521262|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521263|NCT00288080|O2|Outcome|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521264|NCT00288080|O1|Outcome|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521265|NCT00288080|E2|Reported Event|Androgen Suppression + Radiation Therapy + Chemotherapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT. Following completion of RT, 6 cycles of docetaxel (premedicated with dexamethasone) and prednisone are delivered concurrently with androgen suppression.
521266|NCT00288080|E1|Reported Event|Androgen Suppression + Radiation Therapy|Androgen suppression (AS; LHRH agonist and oral antiandrogen) for 8 weeks followed by radiation therapy and concurrent AS. LHRH continues for 24 months after initiation of any treatment, oral antiandrogen discontinues at the end of RT.
521267|NCT00288067|B1|Baseline|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
521319|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521320|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
531091|NCT00252733|B2|Baseline|Placebo|Placebo Comparator
521268|NCT00288067|P1|Participant Flow|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
521269|NCT00288067|O2|Outcome|Fenretinide and Rituximab (Rituximab Pre Treated)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
521270|NCT00288067|O1|Outcome|Fenretinide and Rituximab (Rituximab Naive)|PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8.
521271|NCT00288067|O1|Outcome|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
521272|NCT00288067|E1|Reported Event|Fenretinide and Rituximab|"PHASE I: Patients receive fenretinide PO BID on days 1-5. Treatment repeats weekly for at least 4 weeks in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive fenretinide PO BID on days 1-5 in weeks 1-8 and rituximab IV once weekly in weeks 5-8. Treatment continues in the absence of disease progression or unacceptable toxicity.~pharmacological study : Correlative studies~rituximab : Given IV~fenretinide : Given PO"
521273|NCT00288054|B1|Baseline|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
521274|NCT00288054|P1|Participant Flow|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
521275|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
521276|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
521277|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|
521278|NCT00288054|O1|Outcome|Cohort 1: Cetuximab + Radiotherapy (no Docetaxel)|Eligible patients who began protocol treatment were included in the analysis.
521279|NCT00288054|O1|Outcome|Cetuximab + Chest Radiation Therapy|
521280|NCT00288054|E1|Reported Event|Cetuximab + Chest Radiation Therapy|
521281|NCT00287872|B1|Baseline|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
521282|NCT00287872|P1|Participant Flow|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
521283|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
521284|NCT00287872|O1|Outcome|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
521285|NCT00287872|E1|Reported Event|Bortezomib and Thalidomide|"The patients will receive Bortezomib on days 1, 4, 8 and 11 of each 21 day cycle in combination with daily oral Thalidomide.~bortezomib~thalidomide"
521286|NCT00287729|B3|Baseline|Total|Total of all reporting groups
521287|NCT00287729|B2|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521288|NCT00287729|B1|Baseline|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521289|NCT00287729|P2|Participant Flow|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521290|NCT00287729|P1|Participant Flow|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521291|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521292|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521293|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521294|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521295|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521296|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521297|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521298|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521299|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521300|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521301|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521302|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521303|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521304|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521305|NCT00287729|O2|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521306|NCT00287729|O1|Outcome|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521307|NCT00287729|E2|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521308|NCT00287729|E1|Reported Event|Pirfenidone (2403 mg/d)|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521309|NCT00287716|B4|Baseline|Total|Total of all reporting groups
521310|NCT00287716|B3|Baseline|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521311|NCT00287716|B2|Baseline|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
531596|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
521323|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521324|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521325|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521326|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521327|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521328|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521329|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521330|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521331|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521332|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521333|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521334|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521335|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521336|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521337|NCT00287716|O3|Outcome|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521338|NCT00287716|O2|Outcome|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521339|NCT00287716|O1|Outcome|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521340|NCT00287716|E3|Reported Event|Placebo|placebo equivalent, given as 3 divided doses 3 times/day
521341|NCT00287716|E2|Reported Event|Pirfenidone 1197 mg/Day|pirfenidone, total daily dose of 1197 mg/day, given as 3 divided doses 3 times/day
521342|NCT00287716|E1|Reported Event|Pirfenidone 2403 mg/Day|pirfenidone, total daily dose of 2403 mg/day, given as 3 divided doses 3 times/day
521343|NCT00287339|B3|Baseline|Total|Total of all reporting groups
521344|NCT00287339|B2|Baseline|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
521345|NCT00287339|B1|Baseline|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
521346|NCT00287339|P2|Participant Flow|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
521347|NCT00287339|P1|Participant Flow|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
521348|NCT00287339|O2|Outcome|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
521349|NCT00287339|O1|Outcome|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
521350|NCT00287339|E2|Reported Event|Placebo|Upon successful completion of the run-in period, participants randomized to receive to the placebo arm got a capsule identical to the esomeprazole arm, but containing an inert substance, twice daily for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner.
521351|NCT00287339|E1|Reported Event|Esomeprazole Arm|Upon successful completion of the run-in period, participants in the esomeprazole arm were given the compound at a dose of 40mg for 12 weeks. All participants were instructed to take their study medication 30 minutes before breakfast and 30 minutes before dinner. Esomeprazole was supplied by the investigational pharmacy at the University of North Carolina as blue capsules without identifying features.
521352|NCT00287222|B1|Baseline|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
521353|NCT00287222|P1|Participant Flow|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
521354|NCT00287222|O1|Outcome|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
521355|NCT00287222|E1|Reported Event|Bevacizumab and Erlotinib|Subjects will be treated with bevacizumab and erlotinib
521356|NCT00287079|B3|Baseline|Total|Total of all reporting groups
521357|NCT00287079|B2|Baseline|No Treatment|Participants in this group did not receive any treatment.
521358|NCT00287079|B1|Baseline|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521359|NCT00287079|P2|Participant Flow|No Treatment|Participants in this group did not receive any treatment.
521360|NCT00287079|P1|Participant Flow|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521361|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
521362|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521363|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
521364|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521365|NCT00287079|O2|Outcome|No Treatment|Participants in this group did not receive any treatment.
521366|NCT00287079|O1|Outcome|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521367|NCT00287079|E2|Reported Event|No Treatment|Participants in this group did not receive any treatment.
521368|NCT00287079|E1|Reported Event|Rebif 44 Mcg|Rebif was administered subcutaneously (sc) at a dose of 44 microgram (mcg) once weekly.
521369|NCT00287053|B3|Baseline|Total|Total of all reporting groups
521370|NCT00287053|B2|Baseline|2. Active Medication|Active medication
521371|NCT00287053|B1|Baseline|1. Inactive Placebo Pill|Inactive placebo pill
521372|NCT00287053|P2|Participant Flow|2. Active Medication|Active medication
521373|NCT00287053|P1|Participant Flow|1. Inactive Placebo Pill|Inactive placebo pill
521374|NCT00287053|O2|Outcome|2. Active Medication|Active medication
521375|NCT00287053|O1|Outcome|1. Inactive Placebo Pill|Inactive placebo pill
521376|NCT00287053|E2|Reported Event|2. Active Medication|Active medication
521377|NCT00287053|E1|Reported Event|1. Inactive Placebo Pill|Inactive placebo pill
521378|NCT00286754|B4|Baseline|Total|Total of all reporting groups
521379|NCT00286754|B3|Baseline|Usual Care (UC)|treatment as usual for hypertension
521380|NCT00286754|B2|Baseline|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521381|NCT00286754|B1|Baseline|Stage-Matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521382|NCT00286754|P3|Participant Flow|Usual Care (UC)|treatment as usual with no additional counseling
521383|NCT00286754|P2|Participant Flow|Health Education Intervention (HEI)|6 monthly phone calls of non-tailored counseling for diet, medication and exercise
521384|NCT00286754|P1|Participant Flow|Stage-matched Intervention (SM)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521385|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521386|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521387|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521388|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521389|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521390|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521391|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual
521392|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521393|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521394|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521395|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 months of non-tailored counseling for diet, medication and exercise
521396|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521397|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521398|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521399|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521400|NCT00286754|O3|Outcome|Usual Care (UC)|Treatment as usual for hypertension with no counseling
521401|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of non-tailored education about diet, medication and exercise recommendations
521402|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly calls targeting diet, medication and exercise adherence tailored using the Transtheoretical Model
521403|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521404|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
521405|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521406|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521407|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521408|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521409|NCT00286754|O3|Outcome|Usual Care (UC)|treatment as usual for hypertension
521410|NCT00286754|O2|Outcome|Health Education Intervention (HEI)|6 monthly calls of nontailored counseling for diet, medication and exercise
521411|NCT00286754|O1|Outcome|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521412|NCT00286754|E3|Reported Event|Usual Care (UC)|treatment as usual for hypertension
521413|NCT00286754|E2|Reported Event|Health Education Intervention (HEI)|6 monthly phone calls of nontailored counseling for diet, medication and exercise
521414|NCT00286754|E1|Reported Event|Stage-matched Intervention (SMI)|6 monthly phone calls of tailored counseling for diet, medication and exercise based on the Transtheoretical Model
521415|NCT00286741|B3|Baseline|Total|Total of all reporting groups
521416|NCT00286741|B2|Baseline|Arm 2|control
521417|NCT00286741|B1|Baseline|Arm 1|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
521418|NCT00286741|P2|Participant Flow|Control|control
521419|NCT00286741|P1|Participant Flow|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
521420|NCT00286741|O2|Outcome|Treatment as Usual Control|control
521421|NCT00286741|O1|Outcome|Medical Group Visits|"Medical group visits~Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist."
521422|NCT00286741|O2|Outcome|Control|Treatment as Usual Control
521423|NCT00286741|O1|Outcome|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
521424|NCT00286741|E2|Reported Event|Control|Treatment as Usual Control
521425|NCT00286741|E1|Reported Event|Medical Group Visits|Diabetes Group Management Visits: Patients meet in groups and receive education about diabetes, reinforcing each other with their own experiences. Each patient also gets medication management by a physician and pharmacist.
521426|NCT00286728|B3|Baseline|Total|Total of all reporting groups
521427|NCT00286728|B2|Baseline|Arm 2 Usual Care|Usual care
521428|NCT00286728|B1|Baseline|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
521429|NCT00286728|P2|Participant Flow|Arm 2 Usual Care|Usual care
521430|NCT00286728|P1|Participant Flow|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
521431|NCT00286728|O2|Outcome|Arm 2 Usual Care|Usual care
521432|NCT00286728|O1|Outcome|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
521433|NCT00286728|E2|Reported Event|Arm 2 Usual Care|Usual care
521434|NCT00286728|E1|Reported Event|Arm 1 Intensive Referral|"Intensive referral to dual-focused self-help groups~Intensive referral to dual-focused self-help: 4 group sessions to introduce patients to dual focused groups"
521435|NCT00286494|B4|Baseline|Total|Total of all reporting groups
521436|NCT00286494|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521437|NCT00286494|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521438|NCT00286494|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521439|NCT00286494|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521440|NCT00286494|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521441|NCT00286494|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521442|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521443|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521444|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521445|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521446|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521447|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521448|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521449|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521450|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521451|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521452|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521453|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521454|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521455|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521456|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521457|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521458|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521459|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521460|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521461|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521462|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521463|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521464|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521465|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521466|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521467|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521468|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521469|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521470|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521471|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521472|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521473|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521474|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521475|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521476|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521477|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521478|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521479|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521480|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521481|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521482|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521483|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521484|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521485|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521486|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521487|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521488|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521489|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521490|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521491|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521492|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521493|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521494|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521495|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521496|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
531597|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
521497|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521498|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521499|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521500|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521501|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521502|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521503|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521504|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521505|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521506|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521507|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521508|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521509|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521510|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521511|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521512|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521513|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521514|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521515|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521516|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521517|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521518|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521519|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521520|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521521|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521522|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521523|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521524|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521525|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521526|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521527|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521528|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521529|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521530|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521531|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521532|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521533|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521534|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521535|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
531598|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
521536|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521537|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521538|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521539|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521540|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521541|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521542|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521543|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521544|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521545|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521546|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521547|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521548|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521549|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521550|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521551|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521552|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521553|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521554|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521555|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521556|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521557|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521558|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521559|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521560|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521561|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521562|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521563|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521564|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521565|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521566|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521567|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521568|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521569|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521570|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521571|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521572|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521573|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521574|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
531599|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
521575|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521576|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521577|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521578|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521579|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521580|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521581|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521582|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521583|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521584|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521585|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521586|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521587|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521588|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521589|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521590|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521591|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521592|NCT00286494|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521593|NCT00286494|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521594|NCT00286494|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521595|NCT00286494|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521596|NCT00286494|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521597|NCT00286494|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and pioglitazone 30 mg or 45 mg, tablets, orally, once daily for up to 26 weeks.
521598|NCT00286468|B4|Baseline|Total|Total of all reporting groups
521599|NCT00286468|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521600|NCT00286468|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521601|NCT00286468|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521602|NCT00286468|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521603|NCT00286468|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521604|NCT00286468|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521605|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521606|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521607|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521608|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521609|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521610|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521611|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521612|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521613|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521614|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521615|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521616|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521617|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521618|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521619|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521620|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521621|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521622|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521623|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521624|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521625|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521626|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521627|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521628|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521629|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521630|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521631|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521632|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521633|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521634|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521635|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521636|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521637|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521638|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521639|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521640|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521641|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521642|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521643|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521644|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521645|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521646|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521647|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521648|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521649|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521650|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521651|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521652|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521653|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521654|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521655|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521656|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521657|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521658|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521659|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521660|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521661|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521662|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521663|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521664|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521665|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521666|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521667|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521668|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521669|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521670|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521671|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521672|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521673|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521674|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521675|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521676|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521677|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521678|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521679|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521680|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521681|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521682|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521683|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521684|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521685|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521686|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521687|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521688|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521689|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521690|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521691|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521692|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521693|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521694|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521695|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521696|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521697|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521698|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521699|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521700|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521701|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521702|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521703|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521704|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521705|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521706|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521707|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521708|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521709|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521710|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521711|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521712|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521713|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521714|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521715|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521716|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521717|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521718|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521719|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521720|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521721|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521722|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521723|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521724|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521725|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521726|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521727|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521728|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521729|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521730|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521731|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521732|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521733|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521734|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521735|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521736|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521737|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521738|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521739|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521740|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521741|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521742|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521743|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521744|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521745|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521746|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521747|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521748|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521749|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521750|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521751|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521752|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521753|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521754|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521755|NCT00286468|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521756|NCT00286468|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521757|NCT00286468|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521758|NCT00286468|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521759|NCT00286468|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.
521760|NCT00286468|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.
521761|NCT00286455|B4|Baseline|Total|Total of all reporting groups
521762|NCT00286455|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521763|NCT00286455|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521764|NCT00286455|B1|Baseline|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521765|NCT00286455|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521766|NCT00286455|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521767|NCT00286455|P1|Participant Flow|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521768|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521769|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521770|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521771|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521772|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521773|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521774|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521775|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521776|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521777|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521778|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521779|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521780|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521781|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521782|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521783|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521784|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521785|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521786|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521787|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521788|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521789|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521790|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521791|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521792|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521793|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521794|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521795|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521796|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521797|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521798|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521799|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521800|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521801|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521802|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521803|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521804|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521805|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521806|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521807|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521808|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521809|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521810|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521811|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521812|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521813|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521814|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521815|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521816|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521817|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521818|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521819|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521820|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521821|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521822|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521823|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521824|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521825|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521826|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521827|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521828|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521829|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521830|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521831|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521832|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521833|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521834|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521835|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521836|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521837|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521838|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521839|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521840|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521841|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521842|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521843|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521844|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521845|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521846|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521847|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521848|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521849|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521850|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521851|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521852|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521853|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521854|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521855|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521856|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521857|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521858|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521859|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521860|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521861|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521862|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521863|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521864|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521865|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521866|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521867|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521868|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521869|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521870|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521871|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521872|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521873|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521874|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521875|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521876|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521877|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521878|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521879|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521880|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521881|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521882|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521883|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521884|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521885|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521886|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521887|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521888|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521889|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521890|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521891|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521892|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521893|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521894|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521895|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521896|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521897|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521898|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521899|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521900|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521901|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521902|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521903|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521904|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521905|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521906|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521907|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521908|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521909|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521910|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521911|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521912|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521913|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521914|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521915|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521916|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521917|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521918|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521919|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521920|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521921|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521922|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521923|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521924|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521925|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521926|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521927|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521928|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521929|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521930|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521931|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521932|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521933|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521934|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521935|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521936|NCT00286455|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521937|NCT00286455|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521938|NCT00286455|O1|Outcome|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521939|NCT00286455|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily for up to 26 weeks.
521940|NCT00286455|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily for up to 26 weeks.
521941|NCT00286455|E1|Reported Event|Placebo QD|Alogliptin placebo-matching tablets, orally, once daily for up to 26 weeks.
521942|NCT00286442|B4|Baseline|Total|Total of all reporting groups
521943|NCT00286442|B3|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521944|NCT00286442|B2|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521945|NCT00286442|B1|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521946|NCT00286442|P3|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521947|NCT00286442|P2|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521948|NCT00286442|P1|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521949|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521950|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521951|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521952|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521953|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521954|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521955|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521956|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521957|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521958|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521959|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521960|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521961|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521962|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521963|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521964|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521965|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521966|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521967|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521968|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521969|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521970|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521971|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521972|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521973|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521974|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521975|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521976|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521977|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521978|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521979|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521980|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521981|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521982|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521983|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521984|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521985|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521986|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521987|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521988|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522317|NCT00285584|E2|Reported Event|Placebo|Participants in this arm received placebo.
521989|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521990|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521991|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521992|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521993|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521994|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521995|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521996|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521997|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
521998|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
521999|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522000|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522001|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522002|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522003|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522004|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522005|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522006|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522007|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522008|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522009|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522010|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522011|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522012|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522013|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522014|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522015|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522016|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522017|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522018|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522019|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522020|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522021|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522022|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522023|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522024|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522025|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522026|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522027|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522028|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522029|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522030|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522031|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522032|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522033|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522034|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522035|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522036|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522037|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522038|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522039|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522040|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522041|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522042|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522043|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522044|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522045|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522046|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522047|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522048|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522049|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522050|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522051|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522052|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522053|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522054|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522055|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522056|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522057|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522058|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522059|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522060|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522061|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522062|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522063|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522064|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522065|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522066|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522067|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522068|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522069|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522070|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522071|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522072|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522073|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522074|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522075|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522076|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522077|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522078|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522079|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522080|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522081|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522082|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522083|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522084|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522085|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522086|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522087|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522088|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522089|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522090|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522091|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522092|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522093|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522094|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522095|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522096|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522097|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522098|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522099|NCT00286442|O3|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522100|NCT00286442|O2|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522101|NCT00286442|O1|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522102|NCT00286442|E3|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and metformin for up to 26 weeks.
522103|NCT00286442|E2|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522104|NCT00286442|E1|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and metformin for up to 26 weeks.
522105|NCT00286429|B4|Baseline|Total|Total of all reporting groups
522106|NCT00286429|B3|Baseline|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522107|NCT00286429|B2|Baseline|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522108|NCT00286429|B1|Baseline|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522109|NCT00286429|P3|Participant Flow|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522110|NCT00286429|P2|Participant Flow|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522111|NCT00286429|P1|Participant Flow|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522112|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522113|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522114|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522115|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522116|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522117|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522118|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522119|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522120|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522121|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522122|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522123|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522124|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522125|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522126|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522127|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522128|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522129|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522130|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522131|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522132|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522133|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522134|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522135|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522136|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522137|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522138|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522139|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522140|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522141|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522142|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522143|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522144|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522145|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522146|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522147|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522148|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522149|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522150|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522151|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522152|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522153|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522154|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522155|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522156|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522157|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522158|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522159|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522160|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522161|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522162|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522163|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522164|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522165|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522166|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522167|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522168|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522169|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522170|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522171|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522172|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522173|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522174|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522175|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522176|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522177|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522178|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522179|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522180|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522181|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522182|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522183|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522184|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522185|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522186|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522187|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522188|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522189|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522190|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522191|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522192|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522193|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522194|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522195|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522196|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522197|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522198|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522199|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522200|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522201|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522202|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522203|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522204|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522205|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522206|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522207|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522208|NCT00286429|O3|Outcome|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522209|NCT00286429|O2|Outcome|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522210|NCT00286429|O1|Outcome|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522211|NCT00286429|E3|Reported Event|Alogliptin 25 mg QD|Alogliptin 25 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522212|NCT00286429|E2|Reported Event|Alogliptin 12.5 mg QD|Alogliptin 12.5 mg, tablets, orally, once daily and insulin for up to 26 weeks.
522213|NCT00286429|E1|Reported Event|Placebo|Alogliptin placebo-matching tablets, orally, once daily and insulin for up to 26 weeks.
522214|NCT00286325|B1|Baseline|Treated|Open label study subjects all treated with rituximab
522215|NCT00286325|P1|Participant Flow|Treated|Open label study subjects all treated with rituximab
522216|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
522217|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
522218|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
522219|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
522220|NCT00286325|O1|Outcome|Treated|Open label study subjects all treated with rituximab
522221|NCT00286325|E1|Reported Event|Treated|Open label study subjects all treated with rituximab
522222|NCT00286182|B3|Baseline|Total|Total of all reporting groups
522223|NCT00286182|B2|Baseline|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
522224|NCT00286182|B1|Baseline|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
522225|NCT00286182|P2|Participant Flow|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
522226|NCT00286182|P1|Participant Flow|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
522227|NCT00286182|O2|Outcome|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
522228|NCT00286182|O1|Outcome|Erythropoietin Alpha|"Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.~Erythropoietin alpha: Erythropoietin alpha is administered weekly by subcutaneous injection using a pre-specified dosing algorithm. The dosing algorithm is designed to make adjustments based on the rate of rise (ROR) of the hemoglobin over a one week period, as well as the absolute hemoglobin value. Subjects initially received active treatment with 7,500 units of erythropoietin given weekly by subcutaneously injection. Subjects are carefully monitored (e.g. every week) to avoid rapid increases in hemoglobin/hematocrit and/or increasing blood pressure control. Dose adjustments are made if the hemoglobin rises too rapidly (greater than 0.3 g/dL) in"
522229|NCT00286182|E2|Reported Event|Placebo|"Placebo consists of saline injections.~Placebo: Placebo"
522230|NCT00286182|E1|Reported Event|Erythropoietin Alpha|Subcutaneous erythropoietin will be administered once weekly to achieve a target hemoglobin of 13 g/dL. Subjects will be dosed with the study drug for 24 weeks. The administration of study drug will be performed according to a pre-specified treatment algorithm that adjust erythropoietin dosages based on the rate of rise of the hemoglobin.
522231|NCT00286156|B4|Baseline|Total|Total of all reporting groups
522318|NCT00285584|E1|Reported Event|Bupropion|Participants in this arm received bupropion.
522232|NCT00286156|B3|Baseline|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
522233|NCT00286156|B2|Baseline|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
522234|NCT00286156|B1|Baseline|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
522235|NCT00286156|P3|Participant Flow|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
522236|NCT00286156|P2|Participant Flow|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
522237|NCT00286156|P1|Participant Flow|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
522238|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
522239|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
522240|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
522241|NCT00286156|O3|Outcome|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
522242|NCT00286156|O2|Outcome|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
522243|NCT00286156|O1|Outcome|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
522244|NCT00286156|E3|Reported Event|Standard Care|Standard Care: fluid intake primarily water of 2500-3000ml/24hrs, low sodium diet of 2300mg/24 hrs, caffeine avoidance, control of hypertension
522245|NCT00286156|E2|Reported Event|Low Dose Rapamycin (LD)|"Arm 2 Rapamune dose 2-6 mg aimed at maintaining trough levels of 2-5ng/ml~Rapamycin: Group 2 - doses of Rapamune aimed at maintaining trough levels 2-5ng/ml"
522246|NCT00286156|E1|Reported Event|Standard Rapamycin Dose (STD)|"Arm 1 Rapamune dose 2-6mg aimed at maintaining trough levels 5-8 ng/ml~Rapamycin: Group 1- doses of Rapamune aimed at maintaining trough levels 5-8ng/ml"
522247|NCT00286091|B3|Baseline|Total|Total of all reporting groups
522248|NCT00286091|B2|Baseline|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522249|NCT00286091|B1|Baseline|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522250|NCT00286091|P2|Participant Flow|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522251|NCT00286091|P1|Participant Flow|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522252|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522253|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522254|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522255|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522256|NCT00286091|O2|Outcome|Denosumab|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522257|NCT00286091|O1|Outcome|Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind treatment phase. Participants then received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522258|NCT00286091|E4|Reported Event|OLE: Denosumab/ Denosumab 120 mg Q4W|Participants who received denosumab in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension phase.
522259|NCT00286091|E3|Reported Event|OLE: Placebo/ Denosumab 120 mg Q4W|Participants who received placebo in the double-blind treatment phase received open-label denosumab 120 mg by subcutaneous injecton once every 4 weeks for up to 3 years in the open-label extension (OLE) phase.
522260|NCT00286091|E2|Reported Event|DB: Denosumab 120 mg Q4W|Participants received 120 mg densumab administered by subcutaneous injection every 4 weeks in the double-blind treatment phase.
522319|NCT00285467|B3|Baseline|Total|Total of all reporting groups
522261|NCT00286091|E1|Reported Event|DB: Placebo|Participants received placebo subcutaneous injection every 4 weeks (Q4W) in the double-blind (DB) treatment phase.
522262|NCT00286078|B3|Baseline|Total|Total of all reporting groups
522263|NCT00286078|B2|Baseline|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
522264|NCT00286078|B1|Baseline|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
522265|NCT00286078|P2|Participant Flow|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
522266|NCT00286078|P1|Participant Flow|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
522267|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
522268|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
522269|NCT00286078|O2|Outcome|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
522270|NCT00286078|O1|Outcome|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
522271|NCT00286078|E2|Reported Event|Control|"Sham Stimulation up to 12 weeks post-activation. Actual Stimulation from 12 weeks post-activation on.~Precision: Implantable neurostimulator"
522272|NCT00286078|E1|Reported Event|Treatment|"Stimulation on~Precision: Implantable neurostimulator"
522273|NCT00284739|B3|Baseline|Total|Total of all reporting groups
522274|NCT00284739|B2|Baseline|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522275|NCT00284739|B1|Baseline|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522276|NCT00284739|P2|Participant Flow|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522277|NCT00284739|P1|Participant Flow|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522278|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522279|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522280|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522281|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522282|NCT00284739|O2|Outcome|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522283|NCT00284739|O1|Outcome|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522284|NCT00284739|E2|Reported Event|Saline|Multiple normal saline injection into the abscess collection to improve percutaneous drainage
522285|NCT00284739|E1|Reported Event|Alteplase|Multiple Alteplase injection into the abscess collection to improve percutaneous drainage
522286|NCT00285818|B3|Baseline|Total|Total of all reporting groups
522287|NCT00285818|B2|Baseline|Placebo|"Patients receive a placebo pill one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522288|NCT00285818|B1|Baseline|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522289|NCT00285818|P2|Participant Flow|Placebo|"Patients receive a placebo capsule one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522290|NCT00285818|P1|Participant Flow|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522291|NCT00285818|O2|Outcome|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
522292|NCT00285818|O1|Outcome|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522293|NCT00285818|E2|Reported Event|Placebo|Patients receive a placebo pill one day before and for 5 additional days after starting ECT
522294|NCT00285818|E1|Reported Event|Mifepristone|"Patients receive mifepristone one day before and for 5 additional days after starting ECT~Mifepristone: Mifepristone is a glucocorticoid receptor antagonist."
522295|NCT00285779|B3|Baseline|Total|Total of all reporting groups
522296|NCT00285779|B2|Baseline|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
522297|NCT00285779|B1|Baseline|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
522298|NCT00285779|P2|Participant Flow|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
522299|NCT00285779|P1|Participant Flow|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
522300|NCT00285779|O2|Outcome|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
522301|NCT00285779|O1|Outcome|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
522302|NCT00285779|E2|Reported Event|Etanercept|Etanercept: etanercept 50 mg twice weekly for 12 weeks
522303|NCT00285779|E1|Reported Event|Placebo Injection|Placebo: Normal saline twice weekly for 12 weeks
522304|NCT00285584|B3|Baseline|Total|Total of all reporting groups
522305|NCT00285584|B2|Baseline|Placebo|Participants in this arm received placebo.
522306|NCT00285584|B1|Baseline|Bupropion|Participants in this arm received bupropion.
522307|NCT00285584|P2|Participant Flow|Placebo|Participants in this arm received placebo.
522308|NCT00285584|P1|Participant Flow|Bupropion|Participants in this arm received bupropion.
522309|NCT00285584|O2|Outcome|Placebo|
522310|NCT00285584|O1|Outcome|Bupropion|
522311|NCT00285584|O2|Outcome|Placebo|Participants in this arm received placebo.
522312|NCT00285584|O1|Outcome|Bupropion|Participants in this arm received bupropion.
522313|NCT00285584|O2|Outcome|Placebo|
522314|NCT00285584|O1|Outcome|Bupropion|
522315|NCT00285584|O2|Outcome|Placebo|6 months
522320|NCT00285467|B2|Baseline|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
522321|NCT00285467|B1|Baseline|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
522322|NCT00285467|P2|Participant Flow|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
522323|NCT00285467|P1|Participant Flow|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
522324|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
522325|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
522326|NCT00285467|O2|Outcome|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
522327|NCT00285467|O1|Outcome|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
522328|NCT00285467|E2|Reported Event|Cholecalciferol, Inactive Vitamin D|Cholecalciferol is inactive Vitamin D and requires the kidneys to make it active.
522329|NCT00285467|E1|Reported Event|Doxercalciferol, Active Vitamin D|Doxercalciferol is an active Vitamin D readily usable by human body.
522330|NCT00285246|B1|Baseline|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522331|NCT00285246|P1|Participant Flow|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522332|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522333|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522334|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522335|NCT00285246|O1|Outcome|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522336|NCT00285246|E1|Reported Event|All Participants|Army Reserve and National Guard soldiers deploying to a hazardous deployment from Fort Dix, NJ and Camp Shelby, MS
522337|NCT00285207|B3|Baseline|Total|Total of all reporting groups
522338|NCT00285207|B2|Baseline|A007|Experimental A007
522339|NCT00285207|B1|Baseline|Placebo|Placebo (no treatment)
522340|NCT00285207|P2|Participant Flow|A007|Experimental A007
522341|NCT00285207|P1|Participant Flow|Placebo|Placebo (no treatment)
522342|NCT00285207|O2|Outcome|A007|Experimental A007
522343|NCT00285207|O1|Outcome|Placebo|Placebo (no treatment)
522344|NCT00285207|E2|Reported Event|A007|Experimental A007
522345|NCT00285207|E1|Reported Event|Placebo|Placebo (no treatment)
522346|NCT00284180|B3|Baseline|Total|Total of all reporting groups
522347|NCT00284180|B2|Baseline|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
522348|NCT00284180|B1|Baseline|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
522349|NCT00284180|P2|Participant Flow|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle, the dose could be escalated to 320 mg/m2
522350|NCT00284180|P1|Participant Flow|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
522351|NCT00284180|O2|Outcome|Vinflunine/Trastuzumab|Vinflunine 280 mg/m2 every 21 days with trastuzumab administered with a loading dose of 8 mg/kg, followed by 6 mg/kg IV on day 1 of each subsequent cycle, repeated every 21 days. If no grade 3/4 adverse events were encountered after the first cycle of vinflunine/trastuzumab, the dose of vinflunine could be escalated to 320 mg/m2
522352|NCT00284180|O1|Outcome|Vinflunine|Vinflunine 320 mg/m2 intravenously day 1 over 20 minutes repeated every 21 days
522353|NCT00284180|E2|Reported Event|Vinflunine/Trastuzumab|
522354|NCT00284180|E1|Reported Event|Vinflunine|
522355|NCT00284154|B1|Baseline|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522356|NCT00284154|P1|Participant Flow|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522357|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522358|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522359|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522360|NCT00284154|O1|Outcome|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522361|NCT00284154|E1|Reported Event|Vinflunine|Patients received vinflunine 320 mg/m2 every 21 days as a 15- to 20-minute infusion.
522362|NCT00284141|B1|Baseline|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522363|NCT00284141|P1|Participant Flow|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522364|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522365|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
522579|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522366|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
522367|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522368|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522369|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522370|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522371|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522372|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522373|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
522374|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
522375|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
522376|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
522377|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522378|NCT00284141|O2|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by modified RECIST criteria.
522379|NCT00284141|O1|Outcome|Aflibercept 4.0 mg/kg Arm Assessed by Modified RECIST|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks assessed by RECIST criteria.
522380|NCT00284141|E1|Reported Event|4 mg/kg|Participants with metastatic non-small-cell lung adenocarcinoma administered 4.0 mg/kg Aflibercept intravenously every 2 weeks until a study withdrawal criterion was met.
522381|NCT00284089|B5|Baseline|Total|Total of all reporting groups
522382|NCT00284089|B4|Baseline|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
522383|NCT00284089|B3|Baseline|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
522384|NCT00284089|B2|Baseline|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
522385|NCT00284089|B1|Baseline|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
522386|NCT00284089|P4|Participant Flow|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
522407|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522667|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522387|NCT00284089|P3|Participant Flow|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
522388|NCT00284089|P2|Participant Flow|Group A: Ranibizumab 0.5 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.5 mg of ranibizumab once a month for an additional 11 months. Subsequently Group A patients enrolling in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.93 years.
522389|NCT00284089|P1|Participant Flow|Group A: Ranibizumab 0.3 mg|In the single dose phase, all patients randomized in Group A received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye. Those patients who successfully completed this phase entered the multiple dose phase, where they received an intravitreal injection of 0.3 mg of ranibizumab once a month for an additional 11 months. Subsequently patients enrolling in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.70 years.
522390|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522391|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522392|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522393|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522394|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522395|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522396|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522397|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522398|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522399|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522400|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
522401|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
522402|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.5 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
522403|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study. Group B patients who enrolled in the extension phase received an intravitreal injection of 0.3 mg of ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
522404|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522405|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522406|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522408|NCT00284089|O2|Outcome|Group B: Ranibizumab 0.5 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522409|NCT00284089|O1|Outcome|Group B: Ranibizumab 0.3 mg|Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye in the multiple dose phase of the study.
522410|NCT00284089|E4|Reported Event|Extension Group A+B: Ranibizumab 0.5 mg|In the extension phase, all patients received an intravitreal injection of 0.5 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.36 years.
522411|NCT00284089|E3|Reported Event|Extension Group A+B: Ranibizumab 0.3 mg|In the extension phase, enrolled patients received an intravitreal injection of 0.3 mg ranibizumab according to an individualized flexible interval regimen guided by monthly best corrected visual acuity scores and other ophthalmic examinations. In the extension phase patients received the same dose level as they received in the multiple dose phase of the study, for an average of 1.45 years.
522412|NCT00284089|E2|Reported Event|Core Group A+B: Ranibizumab 0.5 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.5 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.5 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.5 mg of ranibizumab into the study eye.
522413|NCT00284089|E1|Reported Event|Core Group A+B: Ranibizumab 0.3 mg|“Core” means Single and Multiple Dose Phases. Group A patients received a single intravitreal injection of 0.3 mg of ranibizumab into the study eye, followed by 11 additional intravitreal injections of 0.3 mg of ranibizumab once a month. Group B patients received a total of 12 monthly intravitreal injections of 0.3 mg of ranibizumab into the study eye.
522414|NCT00285012|B3|Baseline|Total|Total of all reporting groups
522415|NCT00285012|B2|Baseline|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522416|NCT00285012|B1|Baseline|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522417|NCT00285012|P2|Participant Flow|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522418|NCT00285012|P1|Participant Flow|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522419|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522420|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522421|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522422|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522423|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522424|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522425|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522426|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522427|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522428|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522429|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522430|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522431|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522432|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522433|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522434|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522435|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522436|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522437|NCT00285012|O2|Outcome|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522438|NCT00285012|O1|Outcome|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522439|NCT00285012|E2|Reported Event|Placebo|Placebo 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522440|NCT00285012|E1|Reported Event|Varenicline|Varenicline 0.5 milligrams (mg) once daily (QD) for 3 days; followed by 0.5 mg twice daily (BID) for 4 days; then 1 mg BID for 11 weeks.
522441|NCT00284934|B3|Baseline|Total|Total of all reporting groups
531600|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
522442|NCT00284934|B2|Baseline|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522443|NCT00284934|B1|Baseline|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522444|NCT00284934|P2|Participant Flow|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522445|NCT00284934|P1|Participant Flow|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522446|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522447|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522448|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522449|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522450|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522451|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522452|NCT00284934|O2|Outcome|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522453|NCT00284934|O1|Outcome|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522454|NCT00284934|E2|Reported Event|High EC-MPS|Patients received 1440 mg/day (720 mg twice a day orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose tapered to reach a trough blood level target of between 2 and 4.5 ng/mL within 15 days after randomization. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522455|NCT00284934|E1|Reported Event|Standard Dose EC-MPS|Patients received 720 mg/day (360 mg twice a day (bid) orally) Enteric-coated mycophenolate sodium (EC-MPS) and tacrolimus (twice a day orally) dose adjusted to maintain a trough blood level (C0) between 5.5 and 10 ng/mL. The randomization was stratified on 1 factor: treatment with or without steroids. Prednisone (or oral equivalent) was administrated to patients as before entering the study and as per center’s standard practice, but at a dose of at least 5 mg/day.
522456|NCT00284856|B4|Baseline|Total|Total of all reporting groups
522457|NCT00284856|B3|Baseline|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522458|NCT00284856|B2|Baseline|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522459|NCT00284856|B1|Baseline|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522460|NCT00284856|P3|Participant Flow|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522461|NCT00284856|P2|Participant Flow|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522462|NCT00284856|P1|Participant Flow|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522463|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522464|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522465|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522466|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522467|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522468|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522469|NCT00284856|O3|Outcome|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522470|NCT00284856|O2|Outcome|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522471|NCT00284856|O1|Outcome|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522472|NCT00284856|E3|Reported Event|Placebo|Montelukast matching placebo 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522473|NCT00284856|E2|Reported Event|Fluticasone|Fluticasone propionate 250 mcg twice daily and Montelukast matching placebo 10 mg tablet once daily at bedtime for 6 months
522474|NCT00284856|E1|Reported Event|Montelukast|Montelukast 10 mg tablet once daily at bedtime and Fluticasone propionate matching placebo 250 mcg twice daily for 6 months
522475|NCT00284557|B3|Baseline|Total|Total of all reporting groups
522476|NCT00284557|B2|Baseline|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
522477|NCT00284557|B1|Baseline|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
522478|NCT00284557|P2|Participant Flow|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
522479|NCT00284557|P1|Participant Flow|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
522480|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
522481|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
522482|NCT00284557|O2|Outcome|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
522483|NCT00284557|O1|Outcome|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
522530|NCT00284518|E1|Reported Event|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522531|NCT00284050|B4|Baseline|Total|Total of all reporting groups
522580|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522581|NCT00283842|O5|Outcome|Placebo|
522484|NCT00284557|E2|Reported Event|Health Education Materials Only|Parent-child dyads allocated to Group 2 were provided with a standardized packet of health education materials addressing the recommended items from the expert committee guidelines (e.g., dietary recommendations using the Food Guide Pyramid and the Traffic Light Diet, a general prescription to increase physical activity to 60 minutes daily). They were also given a community resource list that provides contact and program information for community-based obesity treatment activities in their area.
522485|NCT00284557|E1|Reported Event|Group-based Behavioral Intervention|"The group-based behavioral intervention targets eating behaviors, physical activity, and screen time, and is delivered to participating children and their parent/caregiver over the course of 4 weeks. Maintenance sessions occur every 3 months thereafter."
522486|NCT00284518|B5|Baseline|Total|Total of all reporting groups
522487|NCT00284518|B4|Baseline|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522488|NCT00284518|B3|Baseline|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522489|NCT00284518|B2|Baseline|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522490|NCT00284518|B1|Baseline|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522491|NCT00284518|P4|Participant Flow|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522492|NCT00284518|P3|Participant Flow|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522493|NCT00284518|P2|Participant Flow|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522494|NCT00284518|P1|Participant Flow|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522495|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522496|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522497|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522498|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522499|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522500|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522501|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522502|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522503|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522504|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522505|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522506|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522507|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522508|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522509|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522510|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522511|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522512|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522513|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522514|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522515|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522516|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522517|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522518|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522519|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522520|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522521|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522522|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522523|NCT00284518|O4|Outcome|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522524|NCT00284518|O3|Outcome|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522525|NCT00284518|O2|Outcome|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522526|NCT00284518|O1|Outcome|Botulinum Toxin Type A 300 U|Botulinum toxin Type A 300 U transperineal or transrectal injection on Day 1.
522527|NCT00284518|E4|Reported Event|Placebo (Normal Saline)|Placebo (Normal Saline) transperineal or transrectal injection on Day 1.
522528|NCT00284518|E3|Reported Event|Botulinum Toxin Type A 100 U|Botulinum toxin Type A 100 U transperineal or transrectal injection on Day 1.
522529|NCT00284518|E2|Reported Event|Botulinum Toxin Type A 200 U|Botulinum toxin Type A 200 U transperineal or transrectal injection on Day 1.
522532|NCT00284050|B3|Baseline|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522533|NCT00284050|B2|Baseline|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522534|NCT00284050|B1|Baseline|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522535|NCT00284050|P3|Participant Flow|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522536|NCT00284050|P2|Participant Flow|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522537|NCT00284050|P1|Participant Flow|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522538|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522539|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522540|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522541|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522542|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522543|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522544|NCT00284050|O3|Outcome|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522577|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522578|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522545|NCT00284050|O2|Outcome|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522546|NCT00284050|O1|Outcome|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522547|NCT00284050|E3|Reported Event|Sham Injection|Participants in the control group received 12 monthly sham intravitreal injections. The evaluation was performed using the same criteria for dose doubling as in active treatment groups. The injection was a mimicked by an empty syringe without a needle. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522548|NCT00284050|E2|Reported Event|Ranibizumab 0.5 mg|Participants received monthly intravitreal injections with 0.5 mg ranibizumab (10 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 1.0 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522549|NCT00284050|E1|Reported Event|Ranibizumab 0.3 mg|Participants received monthly intravitreal injections with 0.3 mg ranibizumab (6 mg/ml) for up to 12 months. At each monthly visit from month 1 and onwards, the evaluating physician decided whether an increase in the dose to 0.6 mg was needed according to set criteria. If the dose was increased, all subsequent administrations were of the higher dose unless treatment had been withheld for more than 45 days (for any reason), in which case injections restarted with the initial dose. Laser photocoagulation was permitted as rescue treatment for the study eye after 3 consecutive monthly injections.
522550|NCT00283868|B3|Baseline|Total|Total of all reporting groups
522551|NCT00283868|B2|Baseline|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522552|NCT00283868|B1|Baseline|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522553|NCT00283868|P2|Participant Flow|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522554|NCT00283868|P1|Participant Flow|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522555|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522556|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522557|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522558|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522559|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522560|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522561|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522562|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522563|NCT00283868|O2|Outcome|Telephone|Patients randomized to this group were only evaluated using telephone and were not evaluated using the digital observation camera or DICOM
522564|NCT00283868|O1|Outcome|Telemedicine|Patients randomized to this group were evaluated using the digital observation camera and DICOM evaluations for telemedicine
522565|NCT00283842|B6|Baseline|Total|Total of all reporting groups
522566|NCT00283842|B5|Baseline|Placebo|
522567|NCT00283842|B4|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522568|NCT00283842|B3|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522569|NCT00283842|B2|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522570|NCT00283842|B1|Baseline|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522571|NCT00283842|P5|Participant Flow|Placebo|
522572|NCT00283842|P4|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522573|NCT00283842|P3|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522574|NCT00283842|P2|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522575|NCT00283842|P1|Participant Flow|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522576|NCT00283842|O5|Outcome|Placebo|
522582|NCT00283842|O4|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522583|NCT00283842|O3|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522584|NCT00283842|O2|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522585|NCT00283842|O1|Outcome|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522586|NCT00283842|E5|Reported Event|Placebo|
522587|NCT00283842|E4|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 400mg|400mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522588|NCT00283842|E3|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 200mg|200mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522589|NCT00283842|E2|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 100mg|100mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522590|NCT00283842|E1|Reported Event|Desvenlafaxine Succinate Sustained-release (DVS SR) 50mg|50mg tablets of desvenlafaxine succinate sustained-release (DVS SR) taken orally
522591|NCT00283816|B3|Baseline|Total|Total of all reporting groups
522592|NCT00283816|B2|Baseline|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
522593|NCT00283816|B1|Baseline|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
522594|NCT00283816|P2|Participant Flow|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
522595|NCT00283816|P1|Participant Flow|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
522596|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
522597|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
522598|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
522599|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
522600|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive
522601|NCT00283816|O1|Outcome|Metformin|metformin 2000mg in addition to oral contraceptive
522602|NCT00283816|O2|Outcome|Placebo|placebo pill in addition to oral contraceptive pill
522603|NCT00283816|O1|Outcome|Metformin|2000mg of metformin in addition to oral contraceptive
522604|NCT00283816|E2|Reported Event|Placebo|Subjects given a placebo in addition to oral contraceptive and lifestyle program
522605|NCT00283816|E1|Reported Event|Metformin|Subjects given 2000mg of metformin in addition to oral contraceptive and a lifestyle program
522606|NCT00283712|B3|Baseline|Total|Total of all reporting groups
522607|NCT00283712|B2|Baseline|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522608|NCT00283712|B1|Baseline|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522609|NCT00283712|P2|Participant Flow|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522610|NCT00283712|P1|Participant Flow|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522611|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522612|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522613|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522614|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522615|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522665|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522666|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522616|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522617|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522618|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522619|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522620|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522621|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522622|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522623|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522624|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522625|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522626|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522627|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522628|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522629|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522630|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522631|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522632|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522633|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522634|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522635|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522636|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522637|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522638|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522639|NCT00283712|O2|Outcome|Placebo Comparator: Placebo|"Participants were randomized to receive intravenous infusions of placebo (5 mg/kg comprised of a white lyophilized powder reconstituted in 10 mL of Sterile Water for Injection, USP) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522640|NCT00283712|O1|Outcome|Experimental: Infliximab (Remicade, Revellex)|"Participants were randomized to receive intravenous infusions of infliximab (5mg/kg reconstituted in 10 mL of Sterile Water for Injection, USP ) at Weeks 0, 2, 6, and 14 over a time period of no less than two hours in a blinded (masked) fashion. Refer to section titled, Detailed Description for additional treatment information."
522641|NCT00283712|E2|Reported Event|Placebo|Subjects randomized to the Placebo group
522642|NCT00283712|E1|Reported Event|Infliximab|Subjects randomized to the Infliximab group
522643|NCT00283686|B5|Baseline|Total|Total of all reporting groups
522644|NCT00283686|B4|Baseline|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
522645|NCT00283686|B3|Baseline|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
522646|NCT00283686|B2|Baseline|ACE-I/ARB and Low BP|"ACE-I + ARB and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
522647|NCT00283686|B1|Baseline|ACE-I/ARB and Standard BP|"ACE-I + ARB and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
522648|NCT00283686|P4|Participant Flow|ACE-I/Placebo and Low BP|"ACE-I + Placebo and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
522649|NCT00283686|P3|Participant Flow|ACE-I/Placebo and Standard BP|"ACE-I + Placebo and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Placebo: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and placebo titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
522650|NCT00283686|P2|Participant Flow|ACE-I/ARB and Low BP|"ACE-I + angiotensin-receptor blocker (ARB) and low blood pressure control of 95-110/60-75 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve low blood pressure control of 95-110/60-75 mm Hg."
522651|NCT00283686|P1|Participant Flow|ACE-I/ARB and Standard BP|"ACE-I + angiotensin-receptor blocker (ARB) and standard blood pressure control of 120-130/70-80 mm Hg~Lisinopril and Telmisartan: Lisinopril titrated to 5mg, 10mg, 20mg, 40mg and telmisartan titrated to 40mg and 80mg, as tolerated by participants, to achieve standard blood pressure control of 120-130/70-80 mm Hg."
522652|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522653|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522654|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522655|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522656|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522657|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522658|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522659|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522660|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522661|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522662|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522663|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522664|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522668|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522669|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522670|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522671|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522672|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522673|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522674|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522675|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522676|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522677|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522678|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522679|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522680|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522681|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522682|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522683|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522684|NCT00283686|O4|Outcome|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522685|NCT00283686|O3|Outcome|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522686|NCT00283686|O2|Outcome|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522687|NCT00283686|O1|Outcome|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522688|NCT00283686|E4|Reported Event|Standard Blood Pressure Group|Targeted blood pressure was 120/70 to 130/80 mm Hg
522689|NCT00283686|E3|Reported Event|Low Blood Pressure Group|Targeted blood pressure was 95/60 to 110/75 mm Hg
522690|NCT00283686|E2|Reported Event|ACE-I Alone|ACE-I monotherapy (lisinopril only)
522691|NCT00283686|E1|Reported Event|ACE-I + ARB|ACE-I plus ARB (Lisinopril plus telmisartan)
522692|NCT00283595|B3|Baseline|Total|Total of all reporting groups
522693|NCT00283595|B2|Baseline|Placebo Group|Treatment with Placebo
522694|NCT00283595|B1|Baseline|Recombinant Human Growth Hormone Group|Treatment with rHGH
522695|NCT00283595|P2|Participant Flow|Placebo (Subcutaneous Daily Injection)|Treatment with Placebo
522696|NCT00283595|P1|Participant Flow|Recombinant Human Growth Hormone(Subcutaneous Daily Injection)|Treatment with rHGH
522697|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
522698|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
522699|NCT00283595|O2|Outcome|Placebo Group|Treatment with Placebo
522700|NCT00283595|O1|Outcome|Recombinant Human Growth Hormone Group|Treatment with rHGH
522701|NCT00283595|E2|Reported Event|Placebo Group|Treatment with Placebo
522702|NCT00283595|E1|Reported Event|Recombinant Human Growth Hormone Group|Treatment with rHGH
522703|NCT00283439|B5|Baseline|Total|Total of all reporting groups
522704|NCT00283439|B4|Baseline|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522705|NCT00283439|B3|Baseline|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522706|NCT00283439|B2|Baseline|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522707|NCT00283439|B1|Baseline|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522708|NCT00283439|P4|Participant Flow|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522709|NCT00283439|P3|Participant Flow|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522710|NCT00283439|P2|Participant Flow|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522711|NCT00283439|P1|Participant Flow|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522712|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522713|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522714|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522715|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522716|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522717|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522718|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522719|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522720|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522721|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522722|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522723|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522724|NCT00283439|O4|Outcome|Romiplostim 1000 µg|Romiplostim 1000 µg administered by subcutaneous injection on the first day after chemotherapy
522725|NCT00283439|O3|Outcome|Romiplostim 700 µg|Romiplostim 700 µg administered by subcutaneous injection on the first day after chemotherapy
522726|NCT00283439|O2|Outcome|Romiplostim 300 µg|Romiplostim 300 µg administered by subcutaneous injection on the first day after chemotherapy
522727|NCT00283439|O1|Outcome|Romiplostim 100 µg|Romiplostim 100 µg administered by subcutaneous injection on the first day after chemotherapy
522728|NCT00283439|E4|Reported Event|Romiplostim 1000 µg|
522729|NCT00283439|E3|Reported Event|Romiplostim 700 µg|
522730|NCT00283439|E2|Reported Event|Romiplostim 300 µg|
522731|NCT00283439|E1|Reported Event|Romiplostim 100 µg|
522732|NCT00283400|B5|Baseline|Total|Total of all reporting groups
522733|NCT00283400|B4|Baseline|Dosage Tier 4|25% human albumin 2.5 g/kg
522734|NCT00283400|B3|Baseline|Dosage Tier 3|25% human albumin 1.875 g/kg
522735|NCT00283400|B2|Baseline|Dosage Tier 2|25% human albumin 1.25 g/kg
522736|NCT00283400|B1|Baseline|Dosage Tier 1|25% human albumin 0.625 g/kg
522737|NCT00283400|P4|Participant Flow|Dosage Tier 4|25% human albumin2.5 g/kg
522738|NCT00283400|P3|Participant Flow|Dosage Tier 3|25% human albumin 1.875 g/kg
522739|NCT00283400|P2|Participant Flow|Dosage Tier 2|25% human albumin 1.25 g/kg
522740|NCT00283400|P1|Participant Flow|Dosage Tier 1|25% human albumin 0.625 g/kg
522741|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
522742|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
522743|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
522744|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
522745|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
522746|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
522747|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
522748|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
522749|NCT00283400|O4|Outcome|Dosage Tier 4|25% human albumin 2.5 g/kg
522750|NCT00283400|O3|Outcome|Dosage Tier 3|25% human albumin 1.875 g/kg
522751|NCT00283400|O2|Outcome|Dosage Tier 2|25% human albumin 1.25 g/kg
522752|NCT00283400|O1|Outcome|Dosage Tier 1|25% human albumin 0.625 g/kg
522753|NCT00283400|E4|Reported Event|Dosage Tier 4|25% human albumin 2.5 g/kg
522754|NCT00283400|E3|Reported Event|Dosage Tier 3|25% human albumin 1.875 g/kg
522755|NCT00283400|E2|Reported Event|Dosage Tier 2|25% human albumin 1.25 g/kg
522756|NCT00283400|E1|Reported Event|Dosage Tier 1|25% human albumin 0.625 g/kg
522757|NCT00283387|B1|Baseline|Entire Study Population|Includes groups randomized to receive placebo first and betaine first.
522758|NCT00283387|P2|Participant Flow|Placebo First, Then Betaine|Subjects received oral lactose placebo divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
522759|NCT00283387|P1|Participant Flow|Betaine First, Then Placebo|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old) divided in two doses daily, for 2 months, followed by a 2 month washout period. Subjects then received oral lactose placebo divided in two doses daily, for 2 months.
522760|NCT00283387|O2|Outcome|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
522761|NCT00283387|O1|Outcome|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
522762|NCT00283387|E2|Reported Event|Placebo|Subjects received oral lactose placebo divided in two doses daily, for 2 months.
522763|NCT00283387|E1|Reported Event|Betaine|Subjects received oral betaine 10 gm (subjects >10 yrs old) or 6 gm (subjects <10 yrs old), divided in two doses daily, for 2 months.
522764|NCT00283296|B1|Baseline|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
522765|NCT00283296|P1|Participant Flow|Endeavor Wheelchair|All participants completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair three times each. Testing was completed during a one-day visit that did not exceed 2 1/2 hours. For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
522766|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
522767|NCT00283296|O1|Outcome|Endeavor Wheelchair|For the in-home trial, subjects used the Endeavor as their primary means of mobility for two weeks and their own wheelchair for two weeks.
522768|NCT00283296|O1|Outcome|Endeavor Wheelchair|All participants received an introduction to the Endeavor wheelchair, and completed the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
522769|NCT00283296|E1|Reported Event|Endeavor Wheelchair|Participants will receive an introduction to the Endeavor wheelchair, and will complete the Activities of Daily Living Course with their own personal wheelchair and with the Endeavor chair.
522770|NCT00283075|B1|Baseline|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
522771|NCT00283075|P2|Participant Flow|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
522772|NCT00283075|P1|Participant Flow|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
522773|NCT00283075|O2|Outcome|16 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 16 RENCA macrobeads/kg body weight.
522774|NCT00283075|O1|Outcome|8 RENCA Macrobeads/kg Body Weight Implantation|RENCA macrobeads placement in abdominal cavity at 8 RENCA macrobeads/kg body weight.
522775|NCT00283075|O4|Outcome|Day 28|Tumor marker response at Day 28 after the first implantation.
522776|NCT00283075|O3|Outcome|Day 21|Tumor marker response at Day 21 after the first implantation.
522777|NCT00283075|O2|Outcome|Day 14|Tumor marker response at Day 14 after the first implantation.
522778|NCT00283075|O1|Outcome|Day 7|Tumor marker response at Day 7 after the first implantation.
531601|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
522779|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
522780|NCT00283075|O1|Outcome|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 RENCA macrobeads/kg body weight or 16 RENCA macrobeads/kg body weight.
522781|NCT00283075|E1|Reported Event|All Participants|All participants who had at least one implantation of RENCA macrobeads, either at 8 macrobeads/kg body weight or 16 macrobeads/kg body weight.
522782|NCT00283062|B5|Baseline|Total|Total of all reporting groups
522783|NCT00283062|B4|Baseline|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522784|NCT00283062|B3|Baseline|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522785|NCT00283062|B2|Baseline|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522786|NCT00283062|B1|Baseline|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522787|NCT00283062|P4|Participant Flow|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522788|NCT00283062|P3|Participant Flow|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522789|NCT00283062|P2|Participant Flow|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522790|NCT00283062|P1|Participant Flow|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522791|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522792|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522793|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522794|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522795|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522796|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522797|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522798|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522799|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522800|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522801|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522802|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522803|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522804|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522805|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522806|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522807|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522808|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522809|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522810|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522811|NCT00283062|O4|Outcome|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522812|NCT00283062|O3|Outcome|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522813|NCT00283062|O2|Outcome|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522814|NCT00283062|O1|Outcome|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522815|NCT00283062|E4|Reported Event|Leuprolide Acetate - Deferred Treatment (D-HT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 22.5 mg leuprolide acetate every 3 months for 18 months.
522816|NCT00283062|E3|Reported Event|Docetaxel / Leuprolide Acetate - Deferred Treatment (D-CHT)|Participants in whom treatment was deferred from randomization until first progression - i.e. PSA progression and/or radiologically or histologically documented progression. Participants were treated with 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months.
522817|NCT00283062|E2|Reported Event|Leuprolide Acetate - Immediate Treatment (I-HT)|Participants administered 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522818|NCT00283062|E1|Reported Event|Docetaxel / Leuprolide Acetate - Immediate Treatment (I-CHT)|Participants administered 75 mg/m^2 docetaxel every three weeks (q3w) for 6 cycles in combination with 22.5 mg leuprolide acetate every 3 months for 18 months immediately following prostatectomy.
522819|NCT00283049|B4|Baseline|Total|Total of all reporting groups
522820|NCT00283049|B3|Baseline|MET+SU + IG|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
522821|NCT00283049|B2|Baseline|MET + TZD + IG|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a thiazolidinedione (TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
522822|NCT00283049|B1|Baseline|SU + TZD + IG|Arm 1: Insulin glargine(IG) administered subcutaneously once daily plus a sulfonylurea and a thiazolidinedione(TZD). Insulin glulisine will be added after Week 12 or later for those subjects needing additional prandial insulin therapy (HbA1c >6.5%)
522823|NCT00283049|P3|Participant Flow|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522824|NCT00283049|P2|Participant Flow|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522825|NCT00283049|P1|Participant Flow|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522826|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522827|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522881|NCT00282971|P1|Participant Flow|Inhaled Insulin|Inhaled insulin plus oral therapy
531602|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
522828|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522829|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522830|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522831|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522832|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522833|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522834|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522835|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522836|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522837|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522838|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522839|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522840|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522841|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522842|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522843|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522844|NCT00283049|O3|Outcome|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522845|NCT00283049|O2|Outcome|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522846|NCT00283049|O1|Outcome|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522847|NCT00283049|E3|Reported Event|Insulin Glargine + Metformin (MET) + Sulfonylurea (SU)|Arm 3: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a sulfonylurea. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522848|NCT00283049|E2|Reported Event|Insulin Glargine + Metformin (MET) + Thiazolidinedione (TZD)|Arm 2: Insulin glargine (IG) administered subcutaneously once daily plus metformin and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522849|NCT00283049|E1|Reported Event|Insulin Glargine + Sulfonylurea (SU) + Thiazolidinedione (TZD)|Arm 1: Insulin glargine (IG) administered subcutaneously once daily plus a sulfonylurea and a TZD. Insulin glulisine will be added after Week 12 or later for those subjects needing prandial insulin therapy (HbA1c >6.5%)
522850|NCT00282984|B3|Baseline|Total|Total of all reporting groups
522851|NCT00282984|B2|Baseline|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522882|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522852|NCT00282984|B1|Baseline|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522853|NCT00282984|P2|Participant Flow|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522854|NCT00282984|P1|Participant Flow|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522855|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522856|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522857|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522858|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522859|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522860|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522861|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522862|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522863|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522864|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522865|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522866|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522867|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522868|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522869|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522870|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522871|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522872|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522873|NCT00282984|O2|Outcome|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522874|NCT00282984|O1|Outcome|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522875|NCT00282984|E2|Reported Event|Placebo (Pbo)|1 week titration followed by 11 weeks of placebo (pbo). Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522876|NCT00282984|E1|Reported Event|Varenicline (Var)|1 week titration followed by 11 weeks of 1 milligram (mg) twice daily (BID) dosing. Study medication was discontinued at the Week 12 visit and participants' smoking status was followed through the non-treatment period to Week 52.
522877|NCT00282971|B3|Baseline|Total|Total of all reporting groups
522878|NCT00282971|B2|Baseline|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522879|NCT00282971|B1|Baseline|Inhaled Insulin|Inhaled insulin plus oral therapy
522880|NCT00282971|P2|Participant Flow|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522883|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
522884|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522885|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
522886|NCT00282971|O2|Outcome|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522887|NCT00282971|O1|Outcome|Inhaled Insulin|Inhaled insulin plus oral therapy
522888|NCT00282971|E2|Reported Event|Standard of Care|Standard of Care: All licensed diabetes drugs can be prescribed per discretion of investigators
522889|NCT00282971|E1|Reported Event|Inhaled Insulin|Inhaled insulin plus oral therapy
522890|NCT00282919|B1|Baseline|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522891|NCT00282919|P1|Participant Flow|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522892|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522893|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522894|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522895|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522896|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522897|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522898|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522899|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522900|NCT00282919|O1|Outcome|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522901|NCT00282919|E1|Reported Event|Azithromycin and Chloroquine|Four azithromycin 500 milligram (mg) tablets (equivalent to 2000 mg) orally once daily along with 2 chloroquine 300 mg base tablets (equivalent to 600 mg) orally once daily for 3 days.
522902|NCT00282867|B4|Baseline|Total|Total of all reporting groups
522903|NCT00282867|B3|Baseline|Usual Care Group|target level 70 - 300 mg/dL
522904|NCT00282867|B2|Baseline|Loose Control Group|target glucose level 70 – 200 mg/dL
522905|NCT00282867|B1|Baseline|Tight Control Group|target glucose level 70-110 mg/dL
522906|NCT00282867|P3|Participant Flow|Usual Care Group|target level 70 - 300 mg/dL
522907|NCT00282867|P2|Participant Flow|Loose Control Group|target glucose level 70 – 200 mg/dL
522908|NCT00282867|P1|Participant Flow|Tight Control Group|target glucose level 70-110 mg/dL
522909|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
522910|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
522911|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
522912|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
522913|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
522914|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
522915|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
522916|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
522917|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
522918|NCT00282867|O3|Outcome|Usual Care Group|target level 70 - 300 mg/dL
522919|NCT00282867|O2|Outcome|Loose Control Group|target glucose level 70 – 200 mg/dL
522920|NCT00282867|O1|Outcome|Tight Control Group|target glucose level 70-110 mg/dL
522921|NCT00282828|B4|Baseline|Total|Total of all reporting groups
522922|NCT00282828|B3|Baseline|Sertraline and Placebo|Participants will take both sertraline and placebo
522923|NCT00282828|B2|Baseline|Venlafaxine|Participants will take venlafaxine only
522924|NCT00282828|B1|Baseline|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
522925|NCT00282828|P3|Participant Flow|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
522926|NCT00282828|P2|Participant Flow|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
522927|NCT00282828|P1|Participant Flow|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
522928|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
522929|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
522930|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
523527|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
522931|NCT00282828|O3|Outcome|Sertraline and Placebo|Phase I non-responders randomized to this group received prolonged sertraline and placebo.
522932|NCT00282828|O2|Outcome|Venlafaxine|Phase I non-responders randomized to this group switched to venlafaxine with flexible titration up to 225 mg/d.
522933|NCT00282828|O1|Outcome|Sertraline and Clonazepam|Phase I non-responders randomized to this group remained on sertraline with the addition of clonazepam up to 3.0mg/d.
522934|NCT00282828|E3|Reported Event|Sertraline and Placebo|Participants will take both sertraline and placebo
522935|NCT00282828|E2|Reported Event|Venlafaxine|Participants will take venlafaxine only
522936|NCT00282828|E1|Reported Event|Sertraline and Clonazepam|Participants will take both sertraline and clonazepam
522937|NCT00282815|B3|Baseline|Total|Total of all reporting groups
522938|NCT00282815|B2|Baseline|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
522939|NCT00282815|B1|Baseline|Active Continuous Positive Airway Pressure (CPAP)|
522940|NCT00282815|P2|Participant Flow|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
522941|NCT00282815|P1|Participant Flow|Active Continuous Positive Airway Pressure (CPAP)|
522942|NCT00282815|O2|Outcome|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
522943|NCT00282815|O1|Outcome|Active Continuous Positive Airway Pressure (CPAP)|
522944|NCT00282815|O1|Outcome|After Randomization|
522945|NCT00282815|O2|Outcome|Sham CPAP|
522946|NCT00282815|O1|Outcome|Active CPAP|
522947|NCT00282815|E2|Reported Event|Sham Continuous Positive Airway Pressure (CPAP)|Subtherapeutic CPAP
522948|NCT00282815|E1|Reported Event|Active Continuous Positive Airway Pressure (CPAP)|
522949|NCT00281697|B3|Baseline|Total|Total of all reporting groups
522950|NCT00281697|B2|Baseline|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522951|NCT00281697|B1|Baseline|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522952|NCT00281697|P2|Participant Flow|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522953|NCT00281697|P1|Participant Flow|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522954|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522955|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522956|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522957|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522958|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522959|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522960|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522961|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522962|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522963|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522964|NCT00281697|O2|Outcome|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
522965|NCT00281697|O1|Outcome|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522966|NCT00281697|E2|Reported Event|Standard Chemotherapy + Placebo|Patients received one of several standard chemotherapies for metastatic breast cancer plus placebo to bevacizumab administered IV either every 2 weeks or every 3 weeks depending upon the schedule of chemotherapy chosen.
523011|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522967|NCT00281697|E1|Reported Event|Standard Chemotherapy + Bevacizumab|Patients received one of several standard chemotherapies for metastatic breast cancer plus bevacizumab in a dose of either 10 mg/kg intravenously (IV) every 2 weeks or 15 mg/kg IV every 3 weeks depending upon the schedule of chemotherapy chosen.
522968|NCT00281658|B3|Baseline|Total|Total of all reporting groups
522969|NCT00281658|B2|Baseline|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522970|NCT00281658|B1|Baseline|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522971|NCT00281658|P3|Participant Flow|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily
522972|NCT00281658|P2|Participant Flow|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522973|NCT00281658|P1|Participant Flow|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522974|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522975|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522976|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522977|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522978|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522979|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522980|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522981|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522982|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522983|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522984|NCT00281658|O2|Outcome|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522985|NCT00281658|O1|Outcome|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522986|NCT00281658|E3|Reported Event|Lapatinib 1500 mg|Lapatinib 1500 mg administered once daily. This is not a comparative treatment arm.
522987|NCT00281658|E2|Reported Event|Placebo Plus Paclitaxel|Matching placebo administered once daily plus paclitaxel 80 mg/m^2 administered IV weekly for 3 weeks every 4 weeks
522988|NCT00281658|E1|Reported Event|Lapatinib Plus Paclitaxel|Lapatinib 1500 milligrams (mg) administered once daily plus paclitaxel 80 mg/meters squared (m^2) administered intravenously (IV) weekly for 3 weeks every 4 weeks
522989|NCT00281632|B1|Baseline|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522990|NCT00281632|P1|Participant Flow|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522991|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522992|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522993|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522994|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522995|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522996|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522997|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522998|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
522999|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523000|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523001|NCT00281632|O1|Outcome|Pazopanib 800 mg|: 800 milligrams (mg) pazopanib administered orally once daily
523002|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523003|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523004|NCT00281632|O3|Outcome|Pazopanib 800 mg All|800 milligrams (mg) pazopanib administered orally once daily All participants
523005|NCT00281632|O2|Outcome|Pazopanib 800 mg Non-Responders|800 milligrams (mg) pazopanib administered orally once daily Non-Responders
523006|NCT00281632|O1|Outcome|Pazopanib 800 mg Responders|800 milligrams (mg) pazopanib administered orally once daily Responders
523007|NCT00281632|O3|Outcome|Pazopanib 800 mg All|All participants administered 800 milligrams (mg) pazopanib administered orally once daily
523008|NCT00281632|O2|Outcome|Pazopanib 800 mg Without Measurable Disease|Participants without measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily.
523009|NCT00281632|O1|Outcome|Pazopanib 800 mg With Measurable Disease|Participants with measureable disease at baseline who were administered 800 milligrams (mg) pazopanib administered orally once daily
523010|NCT00281632|O1|Outcome|Overall Study Arm|
523012|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523013|NCT00281632|O1|Outcome|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523014|NCT00281632|E1|Reported Event|Pazopanib 800 mg|800 milligrams (mg) pazopanib administered orally once daily
523015|NCT00282672|B5|Baseline|Total|Total of all reporting groups
523016|NCT00282672|B4|Baseline|HGD Radiofrequency Ablation|
523017|NCT00282672|B3|Baseline|HGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
523018|NCT00282672|B2|Baseline|LGD Radiofrequency Ablation|
523019|NCT00282672|B1|Baseline|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
523020|NCT00282672|P4|Participant Flow|HGD Radiofrequency Ablation|
523021|NCT00282672|P3|Participant Flow|HGD Sham Procedure First Then HGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
523022|NCT00282672|P2|Participant Flow|LGD Radiofrequency Ablation|
523023|NCT00282672|P1|Participant Flow|LGD Sham Procedure First Then LGD Radiofrequency Ablation|After the 1 year follow up was completed, all sham patients were offered cross-over to receive RFA.
523024|NCT00282672|O2|Outcome|All HGD Patients|
523025|NCT00282672|O1|Outcome|All LGD Patients|
523026|NCT00282672|O1|Outcome|All Groups|
523027|NCT00282672|O1|Outcome|All Study Participants|
523028|NCT00282672|O1|Outcome|All Groups|
523029|NCT00282672|O1|Outcome|All Groups|
523030|NCT00282672|O1|Outcome|All Groups|
523031|NCT00282672|O1|Outcome|All Groups|
523032|NCT00282672|O1|Outcome|All Groups|
523033|NCT00282672|O1|Outcome|All Groups|
523034|NCT00282672|O1|Outcome|All Groups|
523035|NCT00282672|O1|Outcome|All Groups|
523036|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
523037|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
523038|NCT00282672|O2|Outcome|LGD Radiofrequency Ablation|
523039|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
523040|NCT00282672|O1|Outcome|All Groups|
523041|NCT00282672|O3|Outcome|HGD to IMC|
523042|NCT00282672|O2|Outcome|LGD to IMC|
523043|NCT00282672|O1|Outcome|LGD to HGD|
523044|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
523045|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
523046|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
523047|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
523048|NCT00282672|O2|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
523049|NCT00282672|O1|Outcome|HGD Radiofrequency Ablation|
523050|NCT00282672|O4|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
523051|NCT00282672|O3|Outcome|HGD Radiofrequency Ablation|
523052|NCT00282672|O2|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
523053|NCT00282672|O1|Outcome|LGD Radiofrequency Ablation|
523054|NCT00282672|O2|Outcome|All HGD Patients|HGD: Sham procedure group crossed over to HGD: Radiofrequency group at 12 month
523055|NCT00282672|O1|Outcome|All LGD Patients|LGD: Sham procedure group crossed over to LGD: Radiofrequency group at 12 month
523056|NCT00282672|O4|Outcome|HGD Radiofrequency Ablation|
523057|NCT00282672|O3|Outcome|HGD Sham Procedure First Then HGD Radiofrequency Ablation|Crossed over to HGD: Radiofrequency
523058|NCT00282672|O2|Outcome|LGD:Radiofrequency|
523059|NCT00282672|O1|Outcome|LGD Sham Procedure First Then LGD Radiofrequency Ablation|Crossed over to LGD:Radiofrequency
523060|NCT00282672|O2|Outcome|HGD:Radiofrequency|
523061|NCT00282672|O1|Outcome|LGD:Radiofrequency|
523062|NCT00282672|O2|Outcome|HGD:Radiofrequency Ablation|
523063|NCT00282672|O1|Outcome|LGD:Radiofrequency Ablation|
523064|NCT00282672|E4|Reported Event|HGD Radiofrequency Ablation|
523065|NCT00282672|E3|Reported Event|HGD Sham Procedure First Then HGD Radiofrequency Ablation|
523066|NCT00282672|E2|Reported Event|LGD Radiofrequency Ablation|
523067|NCT00282672|E1|Reported Event|LGD Sham Procedure First Then LGD Radiofrequency Ablation|
523068|NCT00282568|B1|Baseline|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523069|NCT00282568|P1|Participant Flow|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523118|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523119|NCT00282464|O2|Outcome|Placebo|
523297|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523070|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523071|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523072|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523073|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523074|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523075|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523076|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523077|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523078|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523079|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523150|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523080|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523081|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523082|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523083|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523084|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523085|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523086|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523087|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523088|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523089|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523151|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523090|NCT00282568|O1|Outcome|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523091|NCT00282568|E1|Reported Event|Tacrolimus Modified Release|Participants were enrolled into the study on their stable twice-daily (bid) dose of tacrolimus on Day 1 and continued to receive a stable bid dose of tacrolimus through Day 7. Participants then converted to Tacrolimus Modified Release (MR), administered once daily at an equivalent dose to the patient's previous stable total daily dose of tacrolimus. Participants who completed the 4-week pharmacokinetic treatment period with tacrolimus MR could continue receiving tacrolimus MR as part of the extended treatment period of the study. Dose adjustments were allowed in order to maintain tacrolimus trough concentrations within the target range of 5 to 15 ng/mL and for clinical reasons.
523092|NCT00282464|B3|Baseline|Total|Total of all reporting groups
523093|NCT00282464|B2|Baseline|Placebo|
523094|NCT00282464|B1|Baseline|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523095|NCT00282464|P2|Participant Flow|Placebo|
523096|NCT00282464|P1|Participant Flow|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523097|NCT00282464|O2|Outcome|Placebo|
523098|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523099|NCT00282464|O2|Outcome|Placebo|
523100|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523101|NCT00282464|O2|Outcome|Placebo|
523102|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523103|NCT00282464|O2|Outcome|Placebo|
523104|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523105|NCT00282464|O2|Outcome|Placebo|
523106|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523107|NCT00282464|O2|Outcome|Placebo|
523108|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523109|NCT00282464|O2|Outcome|Placebo|
523110|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523111|NCT00282464|O2|Outcome|Placebo|
523112|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523113|NCT00282464|O2|Outcome|Placebo|
523114|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523115|NCT00282464|O2|Outcome|Placebo|
523116|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523117|NCT00282464|O2|Outcome|Placebo|
523472|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523120|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523121|NCT00282464|O2|Outcome|Placebo|
523122|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523123|NCT00282464|O2|Outcome|Placebo|
523124|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523125|NCT00282464|O2|Outcome|Placebo|
523126|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523127|NCT00282464|O2|Outcome|Placebo|
523128|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523129|NCT00282464|O2|Outcome|Placebo|
523130|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523131|NCT00282464|O2|Outcome|Placebo|
523132|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523133|NCT00282464|O2|Outcome|Placebo|
523134|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523135|NCT00282464|O2|Outcome|Placebo|
523136|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523137|NCT00282464|O2|Outcome|Placebo|
523138|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523139|NCT00282464|O2|Outcome|Placebo|
523140|NCT00282464|O1|Outcome|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523141|NCT00282464|E2|Reported Event|Placebo|
523142|NCT00282464|E1|Reported Event|Ziprasidone 20-80mg Bid|For the Ziprasidone arm, the Baseline card will contain 20 milligrams (mg) twice daily (bid) (one 20 mg capsule) for days 1-2 and 40 mg bid (two 20 mg capsules) for days 3-6. Cards A, B, C, and D will contain either 20 mg bid (one 20 mg capsule), 40 mg bid (two 20 mg capsules), 60 mg bid (one 60 mg capsule), or 80 mg bid (one 60 mg capsule and one 20 mg capsule).
523143|NCT00282347|B3|Baseline|Total|Total of all reporting groups
523144|NCT00282347|B2|Baseline|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523145|NCT00282347|B1|Baseline|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523146|NCT00282347|P2|Participant Flow|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523147|NCT00282347|P1|Participant Flow|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523148|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523149|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523152|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523153|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523154|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523155|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523156|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523157|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523158|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523159|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523160|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523161|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523162|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523163|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523164|NCT00282347|O2|Outcome|Placebo|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523165|NCT00282347|O1|Outcome|Rituximab|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523166|NCT00282347|E4|Reported Event|Placebo - B Cell Follow-up Period|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523167|NCT00282347|E3|Reported Event|Rituximab - B Cell Follow-up Period|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523168|NCT00282347|E2|Reported Event|Placebo - Treatment and Safety Follow-up Periods|Participants received placebo intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523169|NCT00282347|E1|Reported Event|Rituximab - Treatment and Safety Follow-up Periods|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. They also received mycophenolate mofetil, methylprednisolone, diphenhydramine, acetaminophen, and prednisone; see the Detailed Description for details.
523170|NCT00282334|B3|Baseline|Total|Total of all reporting groups
523171|NCT00282334|B2|Baseline|Telemonitoring of Home Blood Press|
523172|NCT00282334|B1|Baseline|Conventional Blood Pressure Monitoring|
523173|NCT00282334|P2|Participant Flow|Conventional|Conventional blood pressure monitoring
523174|NCT00282334|P1|Participant Flow|Telemonitoring|Telemonitoring of home blood pressure
523175|NCT00282334|O2|Outcome|Telemonitoring of Home Blood Press|
523176|NCT00282334|O1|Outcome|Conventional Blood Pressure Monitoring|
523177|NCT00282334|E2|Reported Event|Telemonitoring of Home Blood Press|
523178|NCT00282334|E1|Reported Event|Conventional Blood Pressure Monitoring|
523179|NCT00282308|B3|Baseline|Total|Total of all reporting groups
523180|NCT00282308|B2|Baseline|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523181|NCT00282308|B1|Baseline|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523182|NCT00282308|P3|Participant Flow|All Patients (Combined Groups A and B)|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab. Patients received no treatment during the Safety Follow-up Period.
523183|NCT00282308|P2|Participant Flow|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523184|NCT00282308|P1|Participant Flow|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
531603|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
523185|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523186|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523187|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523188|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523189|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523190|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523191|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523192|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523193|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523194|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523195|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523196|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523197|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523198|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523199|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523200|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523201|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523202|NCT00282308|O2|Outcome|Methotrexate (Group B)|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523203|NCT00282308|O1|Outcome|Rituximab + Methotrexate (Group A)|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523204|NCT00282308|E6|Reported Event|Group B - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
523205|NCT00282308|E5|Reported Event|Group A - Safety Follow-up Period|Patients received no treatment during the Safety Follow-up Period.
523206|NCT00282308|E4|Reported Event|Group B - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
523207|NCT00282308|E3|Reported Event|Group A - Optional Extension Re-treatment Period|Patients who qualified for re-treatment received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/week orally or subcutaneously. Patients received methylprednisolone 100 mg intravenously before each infusion of rituximab.
523208|NCT00282308|E2|Reported Event|Methotrexate (Group B) - Treatment Period|Patients received methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523209|NCT00282308|E1|Reported Event|Rituximab + Methotrexate (Group A) - Treatment Period|Patients received 2 intravenous infusions of rituximab 1000 mg, 14 days apart + methotrexate 10-25 mg/wk orally or subcutaneously during the Treatment Period.
523210|NCT00282282|B1|Baseline|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
523211|NCT00282282|P1|Participant Flow|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
523212|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus GVHD Prophylaxis|
523213|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
523214|NCT00282282|O1|Outcome|Tacrolimus and Sirolimus|
523227|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523215|NCT00282282|E1|Reported Event|Tacrolimus and Sirolimus|Participants received a tacrolimus and sirolimus graft-versus-host disease (GVHD) prophylaxis regimen. Tacrolimus was given 0.05 mg/kg/day (in 2 daily divided doses) orally starting 3 days before bone marrow transplant with a target serum concentration of 5-10ng/mL. Sirolimus was administered with a 12mg oral loading dose 3 days prior to transplantwith a target serum concentration of 3-12ng/mL. Tapering of tacrolimus and sirolimus doses was encouraged starting 64 days after transplant with a goal of discontinuing immunosuppression therapy approximately 6 months after transplant if there were no signs of GVHD.
523216|NCT00282256|B1|Baseline|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523217|NCT00282256|P1|Participant Flow|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523218|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523219|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523220|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523221|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523222|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523223|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523224|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523225|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523226|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523289|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523228|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523229|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523230|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523231|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523232|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523233|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523234|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523235|NCT00282256|O1|Outcome|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523236|NCT00282256|E1|Reported Event|Tacrolimus MR|Participants continued to receive their stable twice daily dose of tacrolimus twice daily on Day 1 through Day 7 and on Day 8 were converted to tacrolimus modified release (MR) once-daily in the morning for 7 days on a 1:1 (mg:mg) basis for their total daily dose. Patients who completed the 2-week pharmacokinetic treatment period were eligible to continue receiving tacrolimus MR as part of the extension treatment period of the study. The extended treatment period began on Day 15 and consisted of a single dose of tacrolimus MR once every morning through the end of the study.
523237|NCT00282243|B1|Baseline|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523238|NCT00282243|P1|Participant Flow|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523290|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Number of major toxicity events
523291|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523292|NCT00282087|E1|Reported Event|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
531604|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
523239|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523240|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523241|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523242|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523243|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523244|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523245|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523246|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523247|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523293|NCT00282048|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523294|NCT00282048|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
531605|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
523248|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523249|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523250|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523251|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523252|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523253|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523254|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523255|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523256|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523295|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523296|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523525|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523257|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523258|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523259|NCT00282243|O1|Outcome|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523260|NCT00282243|E1|Reported Event|Tacrolimus MR|"After enrollment in the pharmacokinetic period, patients were maintained on their usual dose of tacrolimus twice daily on Day 1 through Day 14 and on Day 15 were converted to tacrolimus modified release (MR) once-daily in the morning for 14 days, converted back to tacrolimus twice daily for 14 days and then converted back to tacrolimus MR formulation once-daily in the morning for 14 days, all based on a 1:1 mg for mg total daily dose conversion. The extended treatment period began on day 57 and consisted of a single dose of tacrolimus extended-release formulation once every morning through the end of the study.~Dose adjustments were allowed in order to maintain the target tacrolimus trough level within the range of 5 to 20 ng/mL and for clinical reasons."
523261|NCT00282113|B4|Baseline|Total|Total of all reporting groups
523262|NCT00282113|B3|Baseline|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523263|NCT00282113|B2|Baseline|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523264|NCT00282113|B1|Baseline|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523265|NCT00282113|P3|Participant Flow|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523266|NCT00282113|P2|Participant Flow|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523267|NCT00282113|P1|Participant Flow|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523268|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523269|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523270|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523271|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523272|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523273|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523274|NCT00282113|O3|Outcome|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523275|NCT00282113|O2|Outcome|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523276|NCT00282113|O1|Outcome|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523277|NCT00282113|E3|Reported Event|Placebo|A dilute preparation of pregestimil formula (negligible caloric content)
523278|NCT00282113|E2|Reported Event|Culturelle|Culturelle (Lactobacillus ramnosus GG plus fructo-oligosaccharide) at a dose of 5x10e8 organisms twice daily for five weeks.
523279|NCT00282113|E1|Reported Event|ProBioPlus|ProBioPlus (three bifidobacteria, Lactobacillus acidophilus, and fructo-oligosaccharide) at a dose of 5 x 10e8 organisms twice daily for five weeks
523280|NCT00282087|B1|Baseline|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523281|NCT00282087|P1|Participant Flow|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|Gemcitabine 900 mg/m2 on days 1 and 8 intravenously over 90 minutes, followed by Docetaxel 75 mg/m2 on day 8 intravenously over 1 hour.
523282|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523283|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523284|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523285|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523286|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523287|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523288|NCT00282087|O1|Outcome|Women Treated With Adjuvant Regimen for High Risk Uterine LMS|
523298|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523299|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523300|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523301|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523302|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523303|NCT00282048|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523304|NCT00282048|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet 5 milligram (mg) orally twice daily (BID) for 4 consecutive weeks (28 days cycle) with no interval between cycles.
523305|NCT00281957|B3|Baseline|Total|Total of all reporting groups
523306|NCT00281957|B2|Baseline|Arm II: Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
523307|NCT00281957|B1|Baseline|Arm I: Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
523308|NCT00281957|P2|Participant Flow|Sorafenib + Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
523309|NCT00281957|P1|Participant Flow|Sorafenib + Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
523310|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Sorafenib and Tipifarnib
523311|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Sorafenib and Temsirolimus
523312|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
523313|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
523314|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
523315|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
523316|NCT00281957|O2|Outcome|Sorafenib+Tipifarnib|Patients receive oral sorafenib as in arm I and oral tipifarnib twice daily on days 1-21
523317|NCT00281957|O1|Outcome|Sorafenib+Temsirolimus|Patients receive oral sorafenib twice daily on days 1-28 and temsirolimus IV over 30 minutes on days 1, 8, 15, and 22.
523318|NCT00281957|E2|Reported Event|Arm II|Sorafenib and Tipifarnib
523319|NCT00281957|E1|Reported Event|Arm I|Sorafenib and Temsirolimu
523320|NCT00281918|B3|Baseline|Total|Total of all reporting groups
523321|NCT00281918|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523322|NCT00281918|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523323|NCT00281918|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523324|NCT00281918|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523325|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523326|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523327|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523328|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523329|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523330|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
531606|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
523331|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523332|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523333|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523334|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523335|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523336|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523337|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523338|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523339|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523340|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523341|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523342|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523343|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523344|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523345|NCT00281918|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523346|NCT00281918|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523347|NCT00281918|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: 375 mg/m² IV on Day 0; Cycles 2-6: 500 mg/m² IV on Day 1. FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV over 15-30 min on Days 1, 2, 3 for 6 cycles.
523348|NCT00281918|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
523349|NCT00281879|B9|Baseline|Total|Total of all reporting groups
523360|NCT00281879|P6|Participant Flow|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
523421|NCT00281580|P8|Participant Flow|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523350|NCT00281879|B8|Baseline|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
523351|NCT00281879|B7|Baseline|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
523352|NCT00281879|B6|Baseline|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
523353|NCT00281879|B5|Baseline|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
523354|NCT00281879|B4|Baseline|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
523355|NCT00281879|B3|Baseline|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
523356|NCT00281879|B2|Baseline|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
523357|NCT00281879|B1|Baseline|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
523358|NCT00281879|P8|Participant Flow|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
523359|NCT00281879|P7|Participant Flow|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
523419|NCT00281580|P10|Participant Flow|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523361|NCT00281879|P5|Participant Flow|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
523362|NCT00281879|P4|Participant Flow|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
523363|NCT00281879|P3|Participant Flow|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
523364|NCT00281879|P2|Participant Flow|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
523365|NCT00281879|P1|Participant Flow|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
523366|NCT00281879|O8|Outcome|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor's cells.
523367|NCT00281879|O7|Outcome|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI's.
523368|NCT00281879|O6|Outcome|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days -3 through days -1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
523369|NCT00281879|O5|Outcome|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
523370|NCT00281879|O4|Outcome|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
523420|NCT00281580|P9|Participant Flow|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523371|NCT00281879|O3|Outcome|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
523372|NCT00281879|O2|Outcome|Busulfan and Cyclophosphamide (Cytoxan)|
523373|NCT00281879|O1|Outcome|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|
523374|NCT00281879|E8|Reported Event|Cyclophosphamide, Etoposide (VP16) and TBI (Pediatric Only)|On the day after your admission, you will start receiving radiation therapy (TBI). Radiation will be given to you 2 times a day for 3 days. On the next day, you will then begin your chemotherapy with a drug called etoposide. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm for one day. After the etoposide treatment, on the next day you will receive cyclophosphamide (also known as Cytoxan) for 2 days. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy. This allows your body time to remove and inactivate the chemotherapy. After a day of rest, you will be given your donor’s cells.
523375|NCT00281879|E7|Reported Event|DLI (Donor Leukocyte Infusion)|Donor Leukocyte Infusions: You will receive DLI from your original transplant donor. This will be given through a vein , usually in your arm. It will be similar to getting a platelet or blood transfusion. You may require more than one DLI. The decision to give you another infusion will be determined by your condition, relapse status, GVHD and how much DLI you were given before. You may need chemotherapy and/or radiation to improve your disease status prior to additional DLI’s.
523376|NCT00281879|E6|Reported Event|ATG For Cord Blood Transplants|If you are undergoing a pre-transplant conditioning regimen prior to undergoing a cord blood transplant, you will receive a drug called ATG to improve your chances of engraftment and decrease your risk of graft versus host disease. You may receive ATG 3 times during your transplant regimen on days –3 through days –1 in addition to your pre-transplant conditioning therapy. Methylprednisolone will also be given during each dose of ATG to help reduce any reactions during infusion.
523377|NCT00281879|E5|Reported Event|Busulfan, Cyclophosphamide, and Fludarabine (Pediatric Only)|On the day of your admission you will start to take a drug called Dilantin which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. On the next day, you will then begin your conditioning therapy with a drug called busulfan. This medicine will be given to you by an infusion into your bloodstream through a small tube in the vein of your arm four times per day for four days. After the busulfan treatment, you will receive 4 doses each of two drugs, cyclophosphamide (also known as Cytoxan) and fludarabine, over 2 hours into your vein.
523378|NCT00281879|E4|Reported Event|Low-Dose Fludarabine and TBI(for Second Stem Cell Donation)|A conditioning regimen of low-dose fludarabine and TBI is used in the event that a second donation of hematopoietic stem cells is necessary. Chemotherapy with Fludarabine will begin 4 days prior to your transplant. This drug will be given through the catheter in your chest daily for 3 days. TBI (radiation) will be given to you on the day of your transplant. After your TBI, your donor's stem cells / bone marrow will be given to you through your catheter. The drugs cyclosporine and mycophenolate mofetil (MMF) will be given orally to help you accept your donor's cells.
523379|NCT00281879|E3|Reported Event|BEAM Regimen|On the day of your admission, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Chemotherapy will begin on Day -6 with carmustine (BCNU), followed by etoposide (VP-16), cytosine arabinoside (ARA-C), and melphalan. This conditioning regimen is known as the BEAM regimen. The dose of this therapy is high enough to kill cancer cells but will also kill all of your normal blood forming cells. Subjects undergoing the BEAM regimen will not have total body irradiation (TBI).
523380|NCT00281879|E2|Reported Event|Busulfan and Cyclophosphamide (Cytoxan)|On admission day, you will start to take a drug called Dilantin, which is used to help prevent seizures while you receive your chemotherapy drugs. You will also start to take a drug called allopurinol,which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin the therapy with a drug called busulfan. This medicine is take by mouth four times per day for four days. After the oral busulfan treatment, you will receive two doses of cyclophosphamide over 2 hours by vein (through a small tube leading into the bloodstream). When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. Subjects undergoing the Busulfan and Cyclophosphamide regimen will not have total body irradiation (TBI).
523381|NCT00281879|E1|Reported Event|Cyclophosphamide (Cytoxan) and Total Body Irradiation (TBI)|On admission day, you will start to take a drug called allopurinol which helps to protect your kidneys as your body works to discharge cells killed off by your chemotherapy and TBI. Allopurinol tablets will be given to you by mouth up to three times a day for 7 days. You will begin radiation therapy to your entire body at the start of your transplant treatment. This procedure is called TBI (total body irradiation). Radiation will be given to you 2 times a day for 3 or 4 days. After the radiation treatment, you will receive two doses of cyclophosphamide by vein (through a small plastic tube leading into the bloodstream). Each dose takes about 2 hours to administer. When you are given cyclophosphamide, you will also be given a medication called MESNA to help protect your bladder from damage. After you have completed the cyclophosphamide you will rest one day without any anti-cancer therapy.
523382|NCT00281840|B1|Baseline|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
523383|NCT00281840|P1|Participant Flow|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
523384|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|"bevacizumab: Bevacizumab IV over 30-90 minutes once every 2 weeks for up to 1 year. Bevacizumab, which stops 8 weeks before surgery, may restart 4 weeks after surgery and continue for 9 months in the absence of disease progression or unacceptable toxicity.~docetaxel: docetaxel IV over 1 hour once a week for 8 weeks~conventional surgery: 8-10 weeks after the completion of chemoradiotherapy, patients may undergo neck dissection~radiation therapy: radiotherapy once daily, 5 days a week, for 8 weeks"
523385|NCT00281840|O1|Outcome|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
523386|NCT00281840|E1|Reported Event|Bevacizumab With Docetaxel and Radiation Therapy|Radiation therapy will be delivered using standard once-daily fractionation, five days a week for 8 weeks. Bevacizumab is administered intravenously once on day 1 every two weeks during the course of radiation and up to one year following completion of radiation therapy, at which point bevacizumab will be discontinued.Patients meeting planned neck dissection criteria, will not receive bevacizumab therapy following completion of concurrent chemo-radiation therapy (for at least 8 weeks prior to surgery). Bevacizumab therapy will restart 4 weeks after planned neck dissection for nine months.Docetaxel is administered intravenously once per week only during the course of radiation.
523387|NCT00281827|B1|Baseline|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523388|NCT00281827|P1|Participant Flow|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523389|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523390|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523391|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523392|NCT00281827|O1|Outcome|Intent-To-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523393|NCT00281827|O1|Outcome|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523394|NCT00281827|O1|Outcome|Evaluable Patients|Patients receiving 3 complete cycles of treatment (all 3 drugs over 3 - 21 day time periods).
523395|NCT00281827|E1|Reported Event|Intent-to-Treat|Patients receiving at least one dose of each study drug (carboplatin, gemcitabine and thalidomide).
523396|NCT00281580|B17|Baseline|Total|Total of all reporting groups
523397|NCT00281580|B16|Baseline|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523398|NCT00281580|B15|Baseline|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523399|NCT00281580|B14|Baseline|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523400|NCT00281580|B13|Baseline|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523401|NCT00281580|B12|Baseline|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523402|NCT00281580|B11|Baseline|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523403|NCT00281580|B10|Baseline|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523404|NCT00281580|B9|Baseline|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523405|NCT00281580|B8|Baseline|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523406|NCT00281580|B7|Baseline|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523407|NCT00281580|B6|Baseline|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523408|NCT00281580|B5|Baseline|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523409|NCT00281580|B4|Baseline|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523410|NCT00281580|B3|Baseline|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523411|NCT00281580|B2|Baseline|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523412|NCT00281580|B1|Baseline|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523413|NCT00281580|P16|Participant Flow|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523414|NCT00281580|P15|Participant Flow|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523415|NCT00281580|P14|Participant Flow|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523416|NCT00281580|P13|Participant Flow|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523417|NCT00281580|P12|Participant Flow|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523418|NCT00281580|P11|Participant Flow|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523422|NCT00281580|P7|Participant Flow|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523423|NCT00281580|P6|Participant Flow|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523424|NCT00281580|P5|Participant Flow|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523425|NCT00281580|P4|Participant Flow|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523426|NCT00281580|P3|Participant Flow|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523427|NCT00281580|P2|Participant Flow|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523428|NCT00281580|P1|Participant Flow|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523429|NCT00281580|O4|Outcome|Combination Therapy|Telmisartan 20/40/80mg tablet plus 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
523430|NCT00281580|O3|Outcome|Amlodipine Monotherapy|encapsulated Amlodipine 2.5/5 mg capsule or 2 x 5mg capsules, QD in morning
523431|NCT00281580|O2|Outcome|Telmisartan Monotherapy|Telmisartan 20/40/80mg tablet, QD in morning
523432|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523433|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523434|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523435|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523436|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523437|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523438|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523439|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523440|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523441|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523442|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523443|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523444|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523445|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523446|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523447|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523448|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523449|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523450|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523451|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523452|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523453|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523454|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523455|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523456|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523457|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523458|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523459|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523460|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523461|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523462|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523463|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523464|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523465|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523466|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523467|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523468|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523469|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523470|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523471|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523526|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523473|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523474|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523475|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523476|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523477|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523478|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523479|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523480|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523481|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523482|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523483|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523484|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523485|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523486|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523487|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523488|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523489|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523490|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523491|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523492|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523493|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523494|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523495|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523496|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523497|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523498|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523499|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523500|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523501|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523502|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523503|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tab plus 2 encapsulated A5mg capsule, QD in morning
523504|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523505|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523506|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523507|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523508|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523509|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523510|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523511|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523512|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523513|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523514|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523515|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523516|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523517|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523518|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523519|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523520|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523521|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523522|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523523|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523524|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523528|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523529|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523530|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523531|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523532|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523533|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523534|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523535|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523536|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523537|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523538|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523539|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523540|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523541|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523542|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523543|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523544|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523545|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523546|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523547|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523548|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523549|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523550|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523551|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523552|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523553|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523554|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523555|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523556|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523557|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523558|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523559|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523560|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523561|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523562|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523563|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523564|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523565|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523566|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523567|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523568|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523569|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523570|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523571|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523572|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523573|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523574|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523575|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523576|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523577|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523578|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523579|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523580|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
531607|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
523581|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
523582|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
523583|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
523584|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10) - Overall|Overall: including all treatment groups involving A10
523585|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5) - Overall|Overall: including all treatment groups involving A5
523586|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5) - Overall|Overall: including all treatment groups involving A2.5
523587|NCT00281580|O1|Outcome|Amlodipine 0 mg (A0) - Overall|Overall: including Pl, T20, T40, and T80 treatment groups
523588|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
523589|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523590|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523591|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523592|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
523593|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
523594|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
523595|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
523596|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523597|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523598|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523599|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523600|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523601|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523602|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523603|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523604|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523605|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523606|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523607|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523608|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523609|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523610|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523611|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523612|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523613|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523614|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523615|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523616|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523617|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523618|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523619|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523620|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523621|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523622|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523623|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523624|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523625|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523626|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523627|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523628|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523629|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523630|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523631|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523632|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523633|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523634|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523635|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523636|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523637|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523638|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523639|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523640|NCT00281580|O4|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523641|NCT00281580|O3|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523642|NCT00281580|O2|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523643|NCT00281580|O1|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523644|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523645|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523646|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523647|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523648|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523649|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523650|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523651|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523652|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523653|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523654|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523655|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523656|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523657|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523658|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523659|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523660|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523661|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523662|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523663|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523664|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523665|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523666|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523667|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523668|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523669|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523670|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523671|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523672|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523673|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523674|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523675|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523676|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523677|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523678|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523679|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523680|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523681|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523682|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523683|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523684|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523685|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523686|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523687|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523688|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523689|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523690|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523691|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523692|NCT00281580|O15|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523693|NCT00281580|O14|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523694|NCT00281580|O13|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523695|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523696|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523697|NCT00281580|O10|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523698|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523699|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523700|NCT00281580|O7|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523701|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523702|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523703|NCT00281580|O4|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523704|NCT00281580|O3|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523705|NCT00281580|O2|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523706|NCT00281580|O1|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523707|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523708|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523709|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523710|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523711|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523712|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523713|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523714|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523715|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523716|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523717|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523718|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523719|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523720|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523721|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523722|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523723|NCT00281580|O16|Outcome|Amlodipine 10 mg (A10)|2 encapsulated Amlodipine 5 mg capsule, QD in morning
523724|NCT00281580|O15|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523725|NCT00281580|O14|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523726|NCT00281580|O13|Outcome|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|T80mg tab plus 2 encapsulated A5mg capsule, QD in morning
523727|NCT00281580|O12|Outcome|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|T80mg tab plus encapsulated A5mg capsule, QD in morning
523728|NCT00281580|O11|Outcome|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|T80mg tab plus encapsulated A2.5mg capsule, QD in morning
523729|NCT00281580|O10|Outcome|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|T40mg tabl plus 2 encapsulated A5mg capsule, QD in morning
523730|NCT00281580|O9|Outcome|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|T40mg tab plus encapsulated A5mg capsule, QD in morning
523731|NCT00281580|O8|Outcome|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|T40mg tab plus encapsulated A2.5mg capsule, QD in morning
523732|NCT00281580|O7|Outcome|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|T20mg tab plus 2 encapsulated A5mg capsule, QD in morning
523733|NCT00281580|O6|Outcome|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|T20mg tab plus encapsulated A5mg capsule, QD in morning
523734|NCT00281580|O5|Outcome|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|T20mg tab plus encapsulated A2.5mg capsule, QD in morning
523735|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Telmisartan 80mg tablet, QD in morning
523736|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Telmisartan 40mg tablet, QD in morning
523737|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Telmisartan 20mg tablet, QD in morning
523738|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523739|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
523740|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523741|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523742|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523743|NCT00281580|O4|Outcome|Amlodipine 10 mg (A10)|monotherapy (A5 titrated to A10)
523744|NCT00281580|O3|Outcome|Amlodipine 5 mg (A5)|encapsulated Amlodipine 5 mg capsule, QD in morning
523745|NCT00281580|O2|Outcome|Amlodipine 2.5 mg (A2.5)|encapsulated Amlodipine 2.5 mg capsule, QD in morning
523746|NCT00281580|O1|Outcome|Placebo (Pl)|placebo tablet plus encapsulated placebo tablet, QD in morning
523747|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
523748|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
523749|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
523750|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
523751|NCT00281580|O4|Outcome|Telmisartan 80 mg (T80)|Overall: including all treatment groups involving T80
523752|NCT00281580|O3|Outcome|Telmisartan 40 mg (T40)|Overall: including all treatment groups involving T40
523753|NCT00281580|O2|Outcome|Telmisartan 20 mg (T20)|Overall: including all treatment groups involving T20
523754|NCT00281580|O1|Outcome|Telmisartan 0 mg (T0)|Overall: including Pl, A2.5, A5, and A10 treated groups
523755|NCT00281580|E16|Reported Event|Amlodipine 10 mg (A10)|
523756|NCT00281580|E15|Reported Event|Amlodipine 5 mg (A5)|
523757|NCT00281580|E14|Reported Event|Amlodipine 2.5 mg (A2.5)|
523758|NCT00281580|E13|Reported Event|Telmisartan 80 mg Plus Amlodipine 10 mg (T80+A10)|
523759|NCT00281580|E12|Reported Event|Telmisartan 80 mg Plus Amlodipine 5 mg (T80+A5)|
523760|NCT00281580|E11|Reported Event|Telmisartan 80 mg Plus Amlodipine 2.5 mg (T80+A2.5)|
523761|NCT00281580|E10|Reported Event|Telmisartan 80 mg (T80)|
523762|NCT00281580|E9|Reported Event|Telmisartan 40 mg Plus Amlodipine 10 mg (T40+A10)|
523763|NCT00281580|E8|Reported Event|Telmisartan 40 mg Plus Amlodipine 5 mg (T40+A5)|
523764|NCT00281580|E7|Reported Event|Telmisartan 40 mg Plus Amlodipine 2.5 mg (T40+A2.5)|
523765|NCT00281580|E6|Reported Event|Telmisartan 40 mg (T40)|
523766|NCT00281580|E5|Reported Event|Telmisartan 20 mg Plus Amlodipine 10 mg (T20+A10)|
523767|NCT00281580|E4|Reported Event|Telmisartan 20 mg Plus Amlodipine 5 mg (T20+A5)|
523768|NCT00281580|E3|Reported Event|Telmisartan 20 mg Plus Amlodipine 2.5 mg (T20+A2.5)|
523769|NCT00281580|E2|Reported Event|Telmisartan 20 mg (T20)|
523770|NCT00281580|E1|Reported Event|PLACEBO|
523771|NCT00281528|B4|Baseline|Total|Total of all reporting groups
523772|NCT00281528|B3|Baseline|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523773|NCT00281528|B2|Baseline|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523774|NCT00281528|B1|Baseline|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523775|NCT00281528|P3|Participant Flow|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523776|NCT00281528|P2|Participant Flow|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523777|NCT00281528|P1|Participant Flow|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523778|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523779|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523780|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523781|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523782|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523783|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523784|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523785|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523786|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523787|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523788|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523789|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523790|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523791|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523792|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523793|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523794|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523795|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523796|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
531608|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
523797|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523798|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523799|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523800|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523801|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523802|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523803|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523804|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523805|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523806|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523807|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523808|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523809|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523810|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523811|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523812|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523813|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523814|NCT00281528|O3|Outcome|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523815|NCT00281528|O2|Outcome|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523816|NCT00281528|O1|Outcome|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523817|NCT00281528|E3|Reported Event|130 mg/m^2 ABI-007 Weekly|130 mg/m^2 of ABI-007 every week and 10 mg/kg bevacizumab every 2 weeks
523818|NCT00281528|E2|Reported Event|260 mg/m^2 ABI-007 Every 2 Weeks|260 mg/m^2 of ABI-007 every two weeks and 10 mg/kg bevacizumab every 2 weeks
523819|NCT00281528|E1|Reported Event|260 mg/m^2 ABI-007 Every 3 Weeks|260 mg/m^2 of ABI-007 every 3 weeks and 15 mg/kg bevacizumab every 3 weeks.
523820|NCT00281463|B1|Baseline|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
523821|NCT00281463|P1|Participant Flow|Pushrim Activated Power Assist Wheelchair|"Participants will be asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
523822|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
523823|NCT00281463|O1|Outcome|Pushrim Activated Power Assist Wheelchair|Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.
523824|NCT00281463|E1|Reported Event|Pushrim Activated Power Assist Wheelchair|"Participants were asked to propel both their own chair and a pushrim activated power assist wheelchair on a computer controlled wheelchair dynamometer.~Pushrim Activated Power Assist: The PAPAW is an electrically-powered add-on unit for common manual wheelchairs. The unit automatically supplements the users manual pushrim input with additional rear-wheel torque for up to six kilometers/hour traveling velocity. The amount of added torque is provided proportional to the user input to the pushrims. Movement and braking assistance is provided for both forward and rearward travel. Several types and sizes are available based on users operating strength, needs and anthropometry. The PAPAWs to be tested during this study will be the JWII (Yamaha Motor Corporation)."
523825|NCT00281320|B3|Baseline|Total|Total of all reporting groups
523826|NCT00281320|B2|Baseline|Asenapine 5-10 mg BID|Asenapine 5 mg twice daily (BID) on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
523827|NCT00281320|B1|Baseline|Asenapine 2-10 mg BID|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
523828|NCT00281320|P2|Participant Flow|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
523829|NCT00281320|P1|Participant Flow|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Day 5 through the end of the trial (Week 6)
523830|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
531609|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
523831|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
523832|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asenapine for Day 8.
523833|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asenapine for Day 4.
523834|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameters of asepanine for Day 8.
523835|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameters of asepanine for Day 4.
523836|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
523837|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
523838|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
523839|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
523840|NCT00281320|O2|Outcome|Asenapine 10mg BID Day 8|Pharmacokinetic parameter of asepanine for Day 8.
523841|NCT00281320|O1|Outcome|Asenapine 5mg BID Day 4|Pharmacokinetic parameter of asepanine for Day 4.
523842|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
523843|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
523844|NCT00281320|O2|Outcome|Asenapine 5-10 mg BID|Asenapine 5 mg BID on Days 1 to 4 followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
523845|NCT00281320|O1|Outcome|Asenapine 2-10 mg Twice Daily (BID)|Asenapine 2 mg twice daily (BID) on Days 1 and 2, 5 mg BID on Days 3 and 4, followed by 10 mg BID on Days 5 through the end of the trial (Week 6)
523846|NCT00281320|E2|Reported Event|Asenapine 5-10mg BID|
523847|NCT00281320|E1|Reported Event|Asenapine 2-10mg BID|
523848|NCT00281099|B3|Baseline|Total|Total of all reporting groups
523849|NCT00281099|B2|Baseline|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523850|NCT00281099|B1|Baseline|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
523851|NCT00281099|P2|Participant Flow|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523852|NCT00281099|P1|Participant Flow|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
523853|NCT00281099|O1|Outcome|All Screened Patients|All Patients Screened for Possible Enrollment
523854|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523855|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523856|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523857|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523858|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523859|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523860|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523861|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523862|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523863|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523864|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523865|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523866|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523867|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523868|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523869|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523870|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523871|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523872|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523873|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523874|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523875|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523876|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523877|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523878|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523879|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523880|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523881|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523882|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523883|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523884|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523885|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523886|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523887|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523888|NCT00281099|O2|Outcome|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523889|NCT00281099|O1|Outcome|VVI 40|Backup ventricular pacing at a rate of 40 beats per minute
523890|NCT00281099|E2|Reported Event|MVP Pacing|Managed Ventricular Pacing at a rate of 60 beats per minute
523891|NCT00281099|E1|Reported Event|VVI 40 Pacing|Backup ventricular pacing at a rate of 40 beats per minute
523892|NCT00281021|B1|Baseline|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
523893|NCT00281021|P1|Participant Flow|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
523894|NCT00281021|O1|Outcome|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
523895|NCT00281021|E1|Reported Event|Erlotinib and Digoxin|"Erlotinib plus Digoxin~Erlotinib plus Digoxin : Each subject will receive erlotinib and digoxin daily until progression."
523896|NCT00280917|B5|Baseline|Total|Total of all reporting groups
523897|NCT00280917|B4|Baseline|Placebo|Matching Placebo q12 hours for 12 weeks
523898|NCT00280917|B3|Baseline|CF101 4mg|CF101 4 mg q12 hours for 12 weeks
523899|NCT00280917|B2|Baseline|CF101 1mg|CF101 1 mg q12 hours for 12 weeks
523900|NCT00280917|B1|Baseline|CF101 0.1mg|CF101 0.1 mg q12 hours for 12 weeks
523901|NCT00280917|P4|Participant Flow|Placebo|Matching placebo q12 hours orally
523902|NCT00280917|P3|Participant Flow|CF101 4mg|CF101 4mg q12 hours orally
523903|NCT00280917|P2|Participant Flow|CF101 1mg|CF101 1mg q12 hours orally
523904|NCT00280917|P1|Participant Flow|CF101 0.1mg|CF101 0.1 mg q12 hours orally
523905|NCT00280917|O4|Outcome|Placebo|Matching placebo q12 hours for 12 weeks
523906|NCT00280917|O3|Outcome|CF101 4 mg|CF101 4 mg q12 hours for 12 weeks
523907|NCT00280917|O2|Outcome|CF101 1 mg|CF101 1 mg q12 hours for 12 weeks
523908|NCT00280917|O1|Outcome|CF101 0.1 mg|CF101 0.1 mg q12 hours for 12 weeks
523909|NCT00280917|E4|Reported Event|Placebo|Matching placebo
523910|NCT00280917|E3|Reported Event|CF101 4mg|CF101 4 mg given orally q12h for 12 weeks
523911|NCT00280917|E2|Reported Event|CF101 1mg|CF101 1 mg given orally q12h for 12 weeks
523912|NCT00280917|E1|Reported Event|CF101 0.1mg|CF101 0.1 mg given orally q12h for 12 weeks
523913|NCT00280904|B1|Baseline|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
523914|NCT00280904|P1|Participant Flow|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
523915|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated (AI) or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
523916|NCT00280904|O1|Outcome|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo antibiotic impregnated(AI)or standard catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
523917|NCT00280904|E1|Reported Event|Ventriculoperitoneal Shunt Patients|Patients receiving a de novo standard or antibiotic (AI) catheter implant or catheter replacement of a prior ventriculoperitoneal shunt.
523918|NCT00280059|B3|Baseline|Total|Total of all reporting groups
523919|NCT00280059|B2|Baseline|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523920|NCT00280059|B1|Baseline|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523921|NCT00280059|P2|Participant Flow|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523922|NCT00280059|P1|Participant Flow|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523923|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523924|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523925|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523926|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523927|NCT00280059|O8|Outcome|Lamotrigine 500 mg/Day|Lamotrigine 500 mg/day administered BID
523928|NCT00280059|O7|Outcome|Lamotrigine 400 mg/Day|Lamotrigine 400 mg/day administered BID
523929|NCT00280059|O6|Outcome|Lamotrigine 200 mg/Day|Lamotrigine 200 mg/day administered BID
523930|NCT00280059|O5|Outcome|Lamotrigine 100 mg/Day|Lamotrigine 100 mg/day administered BID
523931|NCT00280059|O4|Outcome|Pregabalin 600 mg/Day|Pregabalin 600 mg/day administered BID
523932|NCT00280059|O3|Outcome|Pregabalin 450 mg/Day|Pregabalin 450 mg/day administered BID
523933|NCT00280059|O2|Outcome|Pregabalin 300 mg/Day|Pregabalin 300 mg/day administered BID
523934|NCT00280059|O1|Outcome|Pregabalin 150 mg/Day|Pregabalin 150 mg/day administered twice daily (BID)
523935|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523936|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523937|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523938|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523939|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523940|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523941|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523942|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523943|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523944|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523945|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523946|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523947|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523948|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523949|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523950|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523951|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523952|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523953|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
524016|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
523954|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523955|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523956|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523957|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523958|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523959|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523960|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523961|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523962|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523963|NCT00280059|O2|Outcome|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523964|NCT00280059|O1|Outcome|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523965|NCT00280059|E2|Reported Event|Lamotrigine|Lamotrigine 100, 200, 400, or 500 mg/day orally BID; individual titration based on number of seizures experienced once Level 1 (100 mg/day) was reached and maintained for 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523966|NCT00280059|E1|Reported Event|Pregabalin|Pregabalin 150, 300, 450 or 600 mg/day orally twice daily (BID); individual titration based on number of seizures experienced once Level 1 (150 mg/day) was maintained for at least 7 days, and dose reductions based on intolerable adverse events. Escalation to next dose level allowed only after completing previous dose level for at least 1 week.
523967|NCT00279955|B4|Baseline|Total|Total of all reporting groups
523968|NCT00279955|B3|Baseline|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
523969|NCT00279955|B2|Baseline|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523970|NCT00279955|B1|Baseline|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523971|NCT00279955|P3|Participant Flow|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
523972|NCT00279955|P2|Participant Flow|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523973|NCT00279955|P1|Participant Flow|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523974|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523975|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523976|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523977|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523978|NCT00279955|O2|Outcome|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523979|NCT00279955|O1|Outcome|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523980|NCT00279955|E3|Reported Event|No OptiVol Measurement|All subjects either who were not followed for at least 6 months, or didn't have OptiVol Fluid Index measurements available.
523981|NCT00279955|E2|Reported Event|No OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and never had OptiVol Fliud index crossing 100 during DREP. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523982|NCT00279955|E1|Reported Event|At Least 1 OptiVol Fluid Index > 100 During DREP|All subjects who were followed longer than 6 months and had OptiVol fluid index crossing 100 during DREP. An OptiVol index > 100 indicates potential fluid retention in the lungs. DREP: Diagnostic Risk Evaluation Period which is defined from consent date or implant date to 6 month visit.
523983|NCT00280826|B1|Baseline|Efalizumab|Treatment of cystoid macular edema due to uveitis
523984|NCT00280826|P1|Participant Flow|Efalizumab|Treatment of cystoid macular edema due to uveitis
523985|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
523986|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
523987|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
523988|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
523989|NCT00280826|O1|Outcome|Efalizumab|Treatment of cystoid macular edema due to uveitis
523990|NCT00280826|E1|Reported Event|Efalizumab|Treatment of cystoid macular edema due to uveitis
523991|NCT00280683|B3|Baseline|Total|Total of all reporting groups
523992|NCT00280683|B2|Baseline|Placebo|Placebo intervention
523993|NCT00280683|B1|Baseline|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
523994|NCT00280683|P2|Participant Flow|Placebo|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
523995|NCT00280683|P1|Participant Flow|Arginine|2.3. L-Arginine Intervention The randomization process and disbursement of L-arginine and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded.
523996|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were disbursed by the Investigational Drug Service.
523997|NCT00280683|O1|Outcome|Arginine|L-Arginine Intervention The randomization process and disbursement of L-arginine (0.05 g/kg twice daily; 6-10 g/day) and placebo were done by the UC Davis Investigational Drug Service to ensure that both the physician and participant were blinded. The subjects began the study medication on day 0 and continued for 90 days and were asked to discontinue use of any nutritional supplements prior to the start of the study.
523998|NCT00280683|O2|Outcome|Placebo|Matching placebo tablets were made by Jarrow Formulas.
523999|NCT00280683|O1|Outcome|Arginine|The L-arginine 1g tablets were from Jarrow formulas (Los Angeles, CA). The name of these tablets is Arginine 1000.
524000|NCT00280683|E2|Reported Event|Placebo|Matching placebo tablets were purchased from Jarrow Formulas.
524001|NCT00280683|E1|Reported Event|Arginine|L-arginine 1 g tablets were made by Jarrow Formulas.
524002|NCT00280566|B3|Baseline|Total|Total of all reporting groups
524003|NCT00280566|B2|Baseline|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
524004|NCT00280566|B1|Baseline|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
524005|NCT00280566|P3|Participant Flow|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
524006|NCT00280566|P2|Participant Flow|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
524007|NCT00280566|P1|Participant Flow|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
524008|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524009|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524010|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524011|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524012|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524013|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524014|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524015|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524017|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524018|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524019|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524020|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524021|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524022|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524023|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524024|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524025|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524026|NCT00280566|O2|Outcome|Placebo|Randomized to Double Blind Therapy with Placebo plus mood stabilizer
524027|NCT00280566|O1|Outcome|Ziprasidone|Randomized to Double Blind Therapy with Ziprasidone plus mood stabilizer
524028|NCT00280566|E3|Reported Event|Placebo|Double-blind,randomized to placebo plus mood stabilizer. Subjects were tapered off ziprasidone onto placebo by decreasing 20 mg BID every 2 days during the first week of Period 2
524029|NCT00280566|E2|Reported Event|Ziprasidone|Double-blind, randomized ziprasidone at the dose level received during the last 4 weeks of Open Label Period.
524030|NCT00280566|E1|Reported Event|Period 1 Open Label Ziprasidone|40 - 80 milligram (mg) ziprasidone twice/day (BID) plus mood stabilizer. Dose adjusted on basis of toleration and efficacy.
524031|NCT00280397|B1|Baseline|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524032|NCT00280397|P1|Participant Flow|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524033|NCT00280397|O2|Outcome|E7080 - 20 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524034|NCT00280397|O1|Outcome|E7080 - 16 mg Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524035|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524036|NCT00280397|O1|Outcome|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524037|NCT00280397|E1|Reported Event|E7080 Group|E7080 is administered orally twice a day for 2 weeks to patients with solid tumors that are resistant to approved conventional therapies or for which no appropriate treatment is available.
524038|NCT00280384|B9|Baseline|Total|Total of all reporting groups
524039|NCT00280384|B8|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524040|NCT00280384|B7|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524041|NCT00280384|B6|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524042|NCT00280384|B5|Baseline|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524043|NCT00280384|B4|Baseline|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524044|NCT00280384|B3|Baseline|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524045|NCT00280384|B2|Baseline|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524046|NCT00280384|B1|Baseline|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524047|NCT00280384|P8|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524048|NCT00280384|P7|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524049|NCT00280384|P6|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524050|NCT00280384|P5|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524051|NCT00280384|P4|Participant Flow|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524052|NCT00280384|P3|Participant Flow|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524053|NCT00280384|P2|Participant Flow|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524054|NCT00280384|P1|Participant Flow|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524055|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524056|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524057|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524058|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524059|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524060|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524061|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524062|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524063|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524064|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524065|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524066|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524067|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524068|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524069|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524070|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524071|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524072|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524073|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524074|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524075|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524076|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524077|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524078|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524079|NCT00280384|O8|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524080|NCT00280384|O7|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524128|NCT00279708|B3|Baseline|Total|Total of all reporting groups
524176|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524081|NCT00280384|O6|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524082|NCT00280384|O5|Outcome|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524083|NCT00280384|O4|Outcome|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524084|NCT00280384|O3|Outcome|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524085|NCT00280384|O2|Outcome|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524086|NCT00280384|O1|Outcome|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524087|NCT00280384|E8|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Caucasian|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524088|NCT00280384|E7|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Caucasian|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524089|NCT00280384|E6|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Caucasian|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524090|NCT00280384|E5|Reported Event|E2014 (Botulinum Toxin Type B) Placebo - Caucasian|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Caucasian participants.
524091|NCT00280384|E4|Reported Event|E2014 (Botulinum Toxin Type B) 500 U - Japanese|A single-dose injection solution containing 500 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524092|NCT00280384|E3|Reported Event|E2014 (Botulinum Toxin Type B) 100 U - Japanese|A single-dose injection solution containing 100 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524093|NCT00280384|E2|Reported Event|E2014 (Botulinum Toxin Type B) 20 U - Japanese|A single-dose injection solution containing 20 U/ 0.2 mL of E2014 was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524094|NCT00280384|E1|Reported Event|E2014 (Botulinum Toxin Type B) Placebo- Japanese|A single-dose injection solution of E2014 Placebo was administered to extensor digitorum brevis (EDB) muscle in the left lower limb to Japanese participants.
524095|NCT00280293|B3|Baseline|Total|Total of all reporting groups
524096|NCT00280293|B2|Baseline|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524097|NCT00280293|B1|Baseline|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524098|NCT00280293|P2|Participant Flow|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524099|NCT00280293|P1|Participant Flow|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524100|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524101|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524102|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524103|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524104|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524129|NCT00279708|B2|Baseline|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
524105|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524106|NCT00280293|O2|Outcome|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524107|NCT00280293|O1|Outcome|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524108|NCT00280293|E2|Reported Event|Placebo|Placebo group received medication in identical color/sizes as the lamotrigine group. Placebo therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524109|NCT00280293|E1|Reported Event|Lamotrigine|Lamotrigine therapy was initiated at 25 mg/day and increased to 200 mg/day using a slow upward titration over 5 weeks. After that time additional increases in 100 mg/day increments to a maximum of 400 mg/day were made if the medication was well tolerated and signs of poor response were noted.
524110|NCT00280241|B1|Baseline|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524111|NCT00280241|P1|Participant Flow|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524112|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524113|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524114|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524115|NCT00280241|O1|Outcome|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524116|NCT00280241|E1|Reported Event|FLUDARABINE, CYCLOSPHOSPHAMIDE AND RITUXIMAB|"Fludarabine: Fludarabine is usually administered by IV infusion over 30 minutes or longer.~Cyclophosphamide: The dosage is a solution of 20 mg/mI. IV infusion over 1 hour.~Rituximab: First Infusion: The rituximab solution for infusion should be administered intravenously at an initial rate of 50 mg/hr. Subsequent rituximab infusions can be administered at an initial rate of 100 mg/hr, and increased by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr as tolerated."
524117|NCT00279916|B3|Baseline|Total|Total of all reporting groups
524118|NCT00279916|B2|Baseline|Group 2 (Placebo Nasal Spray)|2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
524119|NCT00279916|B1|Baseline|Group 1 (Nasacort AQ Nasal Spray)|2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
524120|NCT00279916|P2|Participant Flow|Group 2 (Placebo Nasal Spray)|2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
524121|NCT00279916|P1|Participant Flow|Group 1 (Nasacort AQ Nasal Spray)|2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
524122|NCT00279916|O2|Outcome|Group 2 (Placebo Nasal Spray)|2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
524123|NCT00279916|O1|Outcome|Group 1 (Nasacort AQ Nasal Spray)|2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
524124|NCT00279916|O2|Outcome|Group 2 (Placebo Nasal Spray)|2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
524125|NCT00279916|O1|Outcome|Group 1 (Nasacort AQ Nasal Spray)|2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
524126|NCT00279916|E2|Reported Event|Group 2 (Placebo Nasal Spray)|2 metered sprays in eacy nostril daily of an aqueous solution that lacked triamcinolone
524127|NCT00279916|E1|Reported Event|Group 1 (Nasacort AQ Nasal Spray)|2 metered spray in each nostril once daily of aqueous triamcinolone acetonide
524130|NCT00279708|B1|Baseline|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
524131|NCT00279708|P2|Participant Flow|Control Group (Placebo)|Placebo In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
524132|NCT00279708|P1|Participant Flow|Intervention Group (Atorvastatin)|Atorvastatin Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
524133|NCT00279708|O2|Outcome|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study: Placebo vs. Atorvastatin
524134|NCT00279708|O1|Outcome|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
524135|NCT00279708|E2|Reported Event|Control Group (Placebo)|Placebo: In a double-blind fashion, subjects were assigned to receive the sham intervention which appeared the same as the intervention agent. For subjects meeting pre-specified criteria, a 50% dose reduction was applied during the 12 month treatment phase of the study.
524136|NCT00279708|E1|Reported Event|Intervention Group (Atorvastatin)|Atorvastatin: Subjects were assigned to the treatment intervention by way of double blind masking. Atorvastatin 80 mg/day was the initial treatment given, as tolerated for a 12 month period. During the study, a 50% dose reduction was applied for subjects meeting pre-specified criteria.
524137|NCT00279591|B3|Baseline|Total|Total of all reporting groups
524138|NCT00279591|B2|Baseline|Intervention Group|Near Continuous Blood Pressure Monitoring
524139|NCT00279591|B1|Baseline|Control Group|Oscillometric Blood Pressure Monitoring
524140|NCT00279591|P2|Participant Flow|Intervention Group|Near Continuous Blood Pressure Monitoring
524141|NCT00279591|P1|Participant Flow|Control Group|Oscillometric Blood Pressure Monitoring
524142|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
524143|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
524144|NCT00279591|O2|Outcome|Control Group|
524145|NCT00279591|O1|Outcome|Intervention Group|
524146|NCT00279591|O2|Outcome|Control Group|
524147|NCT00279591|O1|Outcome|Intervention Group|
524148|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
524149|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
524150|NCT00279591|O2|Outcome|Intervention Group|Near Continuous Blood Pressure Monitoring
524151|NCT00279591|O1|Outcome|Control Group|Oscillometric Blood Pressure Monitoring
524152|NCT00279591|E2|Reported Event|Intervention Group|Near Continuous Blood Pressure Monitoring
524153|NCT00279591|E1|Reported Event|Control Group|Oscillometric Blood Pressure Monitoring
524154|NCT00279305|B3|Baseline|Total|Total of all reporting groups
524155|NCT00279305|B2|Baseline|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
524156|NCT00279305|B1|Baseline|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
524157|NCT00279305|P2|Participant Flow|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
524158|NCT00279305|P1|Participant Flow|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
524159|NCT00279305|O2|Outcome|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
524160|NCT00279305|O1|Outcome|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
524161|NCT00279305|E2|Reported Event|Placebo|Placebo infusions were given to participants in control group on days 1, 8, 15, and 22.
524162|NCT00279305|E1|Reported Event|Rituximab Treatment|Four intravenous infusions (375 mg per square meter of body-surface area) were given on days 1, 8, 15, and 22 of the study
524163|NCT00279214|B3|Baseline|Total|Total of all reporting groups
524164|NCT00279214|B2|Baseline|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524165|NCT00279214|B1|Baseline|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524166|NCT00279214|P2|Participant Flow|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524167|NCT00279214|P1|Participant Flow|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524168|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524169|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524170|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524171|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524172|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524173|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524174|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524175|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
531610|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
524177|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524178|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524179|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524180|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524181|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524182|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524183|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524184|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524185|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524186|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524187|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524188|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524189|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524190|NCT00279214|O2|Outcome|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524191|NCT00279214|O1|Outcome|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524192|NCT00279214|E2|Reported Event|Control Cohort|Group did not receive drotrecogin alfa (activated) per physician-directed therapy
524193|NCT00279214|E1|Reported Event|Drotrecogin Cohort|Group received drotrecogin alfa (activated) per physician-directed therapy
524194|NCT00279201|B3|Baseline|Total|Total of all reporting groups
524195|NCT00279201|B2|Baseline|Lispro LM|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524196|NCT00279201|B1|Baseline|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524197|NCT00279201|P6|Participant Flow|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524198|NCT00279201|P5|Participant Flow|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524199|NCT00279201|P4|Participant Flow|Lispro Low Mix Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524200|NCT00279201|P3|Participant Flow|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524201|NCT00279201|P2|Participant Flow|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524202|NCT00279201|P1|Participant Flow|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524203|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524204|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524205|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524206|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524207|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524208|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524209|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524210|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524211|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524212|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524213|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524214|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524215|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524216|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524217|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524218|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524219|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524220|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524221|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524222|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524223|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524224|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524225|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524226|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524227|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524228|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524229|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524230|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524231|NCT00279201|O4|Outcome|Lispro Low Mix Prior Glargine Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524232|NCT00279201|O3|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
531611|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
524233|NCT00279201|O2|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524234|NCT00279201|O1|Outcome|Basal Bolus Prior Lispro LM Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524235|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524236|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524237|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524238|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524239|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524240|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524241|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524242|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524243|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524244|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524245|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524246|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524247|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524248|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524249|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524250|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524251|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524252|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524253|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524254|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524255|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524256|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524257|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524258|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524259|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524260|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524261|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524262|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524263|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524264|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524265|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524266|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524267|NCT00279201|O2|Outcome|Lispro LM Participants Who Did Not Maintain Goal|
524268|NCT00279201|O1|Outcome|Lispro LM Participants Who Maintained Goal|
524269|NCT00279201|O2|Outcome|Insulin Glargine Participants Who Did Not Maintain Goal|
524270|NCT00279201|O1|Outcome|Insulin Glargine Participants Who Maintained Goal|
524271|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524272|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524273|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524274|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524275|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524276|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524401|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524277|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524278|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524279|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524280|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524281|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524282|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524283|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks. Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524284|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524285|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524286|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524287|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524288|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524289|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524290|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks Maintenance: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524291|NCT00279201|O2|Outcome|Lispro Low Mix|Initiation Phase: Lispro Low Mix (LM) for 24 weeks Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524292|NCT00279201|O1|Outcome|Insulin Glargine|Initiation Phase: Insulin glargine for 24 weeks. Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524293|NCT00279201|O2|Outcome|Did Not Meet Goal|
524294|NCT00279201|O1|Outcome|Met Goal|
524295|NCT00279201|O2|Outcome|Did Not Meet Goal|
524296|NCT00279201|O1|Outcome|Met Goal|
524297|NCT00279201|O2|Outcome|Did Not Meet Goal|
524298|NCT00279201|O1|Outcome|Met Goal|
524299|NCT00279201|O2|Outcome|Did Not Meet Goal|
524300|NCT00279201|O1|Outcome|Met Goal|
524301|NCT00279201|O2|Outcome|Did Not Meet Goal|
524302|NCT00279201|O1|Outcome|Met Goal|
524303|NCT00279201|O2|Outcome|Did Not Meet Goal|
524304|NCT00279201|O1|Outcome|Met Goal|
524305|NCT00279201|O2|Outcome|Did Not Meet Goal|
524306|NCT00279201|O1|Outcome|Met Goal|
524307|NCT00279201|O2|Outcome|Did Not Meet Goal|
524308|NCT00279201|O1|Outcome|Met Goal|
524309|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524310|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524311|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524312|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524313|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524314|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524315|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524316|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524317|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524318|NCT00279201|O1|Outcome|Insulin Gargine|Insulin glargine for 24 weeks.
524319|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524320|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524321|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524322|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524323|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524324|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524325|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524326|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524327|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524328|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524329|NCT00279201|O4|Outcome|Basal Bolus Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524330|NCT00279201|O3|Outcome|Basal Bolus Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Basal Bolus therapy (combination of insulin glargine and lispro) for 24 weeks in the Intensification Addendum Phase.
524331|NCT00279201|O2|Outcome|Lispro LM Prior Glargine Addendum|Following Insulin Glargine Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Low Mix for 24 weeks in the Intensification Addendum Phase.
524332|NCT00279201|O1|Outcome|Lispro Mid Mix Prior Lispro Low Mix Addendum|Following Lispro LM Initiation Phase, if HbA1c greater than 7.0 after 24 weeks, then instead of entering Maintenance Phase, they could be randomized to receive Lispro Mid Mix for 24 weeks in the Intensification Addendum Phase.
524333|NCT00279201|O2|Outcome|Lispro Low Mix|Maintenance Phase: Up to an additional 2 years of Lispro LM if HbA1c less than or equal to 7.0 at 24 weeks.
524334|NCT00279201|O1|Outcome|Insulin Glargine|Maintenance Phase: Up to an additional 2 years of insulin glargine if glycosylated hemoglobin (HbA1c) less than or equal to 7.0 at 24 weeks.
524335|NCT00279201|O2|Outcome|Lispro Low Mix|Lispro Low Mix (LM) for 24 weeks.
524336|NCT00279201|O1|Outcome|Insulin Glargine|Insulin glargine for 24 weeks.
524337|NCT00279201|E8|Reported Event|Lispro LM Maintenance|
524338|NCT00279201|E7|Reported Event|Insulin Glargine Maintenance|
524339|NCT00279201|E6|Reported Event|Basal Bolus Prior Glargine Addendum|
524340|NCT00279201|E5|Reported Event|Basal Bolus Prior Lispro LM Addendum|
524341|NCT00279201|E4|Reported Event|Lispro LM Prior Glargine Addendum|
524342|NCT00279201|E3|Reported Event|Lispro Mid Mix Prior Lispro LM Addendum|
524343|NCT00279201|E2|Reported Event|Lispro LM Initiation|
524344|NCT00279201|E1|Reported Event|Insulin Glargine Initiation|
524345|NCT00278993|B1|Baseline|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524346|NCT00278993|P1|Participant Flow|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524347|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524348|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524349|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524350|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524351|NCT00278993|O1|Outcome|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524352|NCT00278993|E1|Reported Event|E7389 Intravenous 1.4 mg/m2|E7389 intravenous 1.4 mg/m2 on a 3-week course
524353|NCT00278954|B1|Baseline|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524354|NCT00278954|P1|Participant Flow|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524355|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524356|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524357|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524358|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524359|NCT00278954|O1|Outcome|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524360|NCT00278954|E1|Reported Event|Gammaplex|All subjects received between 300 to 800 mg/kg/infusion of Gammaplex intravenously, every 21 day or 28 days.
524361|NCT00278915|B1|Baseline|Fulvestrant|Fulvestrant (4 mg / kg)
524362|NCT00278915|P1|Participant Flow|Fulvestrant|Fulvestrant (4 mg / kg)
524363|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524364|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524365|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524366|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524367|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524368|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524369|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524370|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524371|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524372|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524373|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524374|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524375|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524376|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524377|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524378|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524379|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524380|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524381|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524382|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524383|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524384|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524385|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524386|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524387|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524388|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524389|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524390|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524391|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524392|NCT00278915|O1|Outcome|Fulvestrant|Fulvestrant (4 mg / kg)
524393|NCT00278915|E1|Reported Event|Fulvestrant|Fulvestrant (4 mg / kg)
524394|NCT00278889|B4|Baseline|Total|Total of all reporting groups
524395|NCT00278889|B3|Baseline|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524396|NCT00278889|B2|Baseline|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524397|NCT00278889|B1|Baseline|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524398|NCT00278889|P3|Participant Flow|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524399|NCT00278889|P2|Participant Flow|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524400|NCT00278889|P1|Participant Flow|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524402|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524403|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524404|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524405|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524406|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524407|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524408|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524409|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524410|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524411|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524412|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524413|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524414|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524415|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524416|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524417|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524418|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524419|NCT00278889|O3|Outcome|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524420|NCT00278889|O2|Outcome|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524421|NCT00278889|O1|Outcome|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524422|NCT00278889|E3|Reported Event|FOLFOX + Bevacizumab 10 mg/kg|FOLFOX + Bevacizumab 10 mg/kg
524423|NCT00278889|E2|Reported Event|FOLFOX + Cediranib 30 mg|FOLFOX + Cediranib 30 mg
524424|NCT00278889|E1|Reported Event|FOLFOX + Cediranib 20 mg|FOLFOX + Cediranib 20 mg
524425|NCT00278876|B1|Baseline|Imatinib Mesylate|patients receiving adjuvant imatinib mesylate
524426|NCT00278876|P1|Participant Flow|Imatinib Mesylate|imatinib mesylate 400 mg daily for 2 years
524427|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
524428|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
524429|NCT00278876|O1|Outcome|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
524430|NCT00278876|E1|Reported Event|Imatinib Mesylate|"patients receiving adjuvant imatinib mesylate~Imatinib mesylate (Glivec): Imatinib mesylate 400mg/day per oral (day 1-28) every 4 weeks"
524431|NCT00278863|B3|Baseline|Total|Total of all reporting groups
524432|NCT00278863|B2|Baseline|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
524433|NCT00278863|B1|Baseline|S-1 for 2 Weeks on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
524434|NCT00278863|P2|Participant Flow|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
524435|NCT00278863|P1|Participant Flow|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
524436|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
524437|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
524438|NCT00278863|O2|Outcome|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
524439|NCT00278863|O1|Outcome|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
524440|NCT00278863|E2|Reported Event|Capecitabine 2 Weeks on/1 Week Off|Capecitabine 2500 mg square meter was administered orally in two divided doses daily on days 1–14 of a 21-day cycle.
524441|NCT00278863|E1|Reported Event|S-1 for 2 Week on/1 Week Off|S-1 was given orally two times daily for 28 days, followed by 14 days’ rest. Three dosage levels of S-1 were defined according to body surface area (BSA) as follows: BSA less than 1.25 m2, 40mg two times daily; BSA, 1.25 to 1.5 m2, 50 mg, two times daily; and BSA more than 1.5 m2, 60 mg two times daily.
524442|NCT00278655|B1|Baseline|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
524443|NCT00278655|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and granulocyte colony-stimulating factor (G-CSF) (5-10mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
524444|NCT00278655|O1|Outcome|Autologous Hematopoietic Stem Cell Transplantation|Patient's own blood stem cells collected after mobilization with cyclophosphamide (2.0 gm/m²)and G-CSF (5-10 mcg/kg/day.Collected stem cells given back to the patient after receiving conditioning regimen (Cyclophosphamide 50 mg/kg/day for four days and either 20 mg alemtuzumab or 6mg/kg rabbit antithymocyte globulin.
524445|NCT00278655|O1|Outcome|Stem Cell Transplantation|Autologous hematopoietic stem cell transplantation Peripheral blood stem cells were mobilised with 2g per square m intravenous (IV) cyclophosphamide (CY) followed by 10 µg per kg subcutaneous filgrastim daily from day 5. After neutrophil recovery, the mobilised cells were collected by apheresis. The recovered cells were unselected and cryopreserved. There was at least three weeks between mobilisation and the conditioning regimen. The conditioning regimen used was 200 mg per kg intravenous CY , given in four equal fractions between day -5 and day -2 with IV mesna, and one 20mg dose of IV alemtuzumab (CAMPATH-1H) given on day -2 with 250 mg intravenous methyl-prednisolone as premedication. Alemtuzumab was changed to rabbit antithymocyte globulin rATG) in the last 4 patients, who received 6 mg per kg rATG over 5 days instead of alemtuzumab . Stem cells wer reinfused 36 h after completion of CY. 5 µg/kg/day filgrastim was given from day 5 until neutrophil recovery.
524446|NCT00278655|E1|Reported Event|Stem Cell Transplantation|"All participants will undergo stem cell transplantation after receiving conditioning regimen.~hematopoietic stem cell transplantation : Autologous hematopoietic stem cell transplantation"
524447|NCT00278525|B3|Baseline|Total|Total of all reporting groups
524448|NCT00278525|B2|Baseline|Standard of Care|medication as standard of care will be given
524449|NCT00278525|B1|Baseline|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
524450|NCT00278525|P2|Participant Flow|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
524451|NCT00278525|P1|Participant Flow|Standard of Care|Cyclophosphamide will be given as approved immunosuppressive therapy
524452|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
524453|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
524454|NCT00278525|O2|Outcome|Standard of Care|Intravenous (IV) will be given 1000 mg/m2 cyclophosphamide monthly for 6 months.
524455|NCT00278525|O1|Outcome|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
524456|NCT00278525|E2|Reported Event|Standard of Care|medication as standard of care will be given
524457|NCT00278525|E1|Reported Event|Stem Cell Trasplantation|intervention as stem cell transplantation after conditioning regimen
524458|NCT00278395|B1|Baseline|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
524459|NCT00278395|P1|Participant Flow|Vorinostat|The oral dose of vorinostat capsules was 300 mg two times a day for 3 consecutive days every week for 4 weeks, which constitutes on cycle of treatment. Treatment will be administered on an outpatient basis.
524460|NCT00278395|O1|Outcome|Vorinostat|The dose of Vorinostat was 300 mg BID on the first 3 days of every week on a 4-week cycle. Dose reduction was allowed for adverse events (AE). Treatment was planned until disease progression (PD), death, unacceptable toxicity, or consent withdrawal.
524461|NCT00278395|E1|Reported Event|Vorinostat|The dose of vorinostat was 300 mg two times a day on the first 3 days of every week on a 4-week cycle.
524462|NCT00277524|B1|Baseline|Overall|All patients enrolled in OMNI.
524463|NCT00277524|P4|Participant Flow|Subjects With CRT-D|Subjects implanted with a cardiac resynchronization therapy defibrillator (CRT-D).
524464|NCT00277524|P3|Participant Flow|Subjects With Dual Chamber ICD|Subjects implanted with a dual chamber implantable cardioverter defibrillator (ICD).
524465|NCT00277524|P2|Participant Flow|Subjects With Single Chamber ICD|Subjects implanted with a single chamber implantable cardioverter defibrillator (ICD).
524466|NCT00277524|P1|Participant Flow|Subjects With IPG|Subjects implanted with an implantable pulse generator (IPG).
524467|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with Implantable Cardioverter Defibrillator, Cardiac Resynchronization Therapy-Defibrillator (ICD/CRT-D).
524468|NCT00277524|O4|Outcome|48-month Follow-up|Total subjects with disease progressed at 48 months
524469|NCT00277524|O3|Outcome|36-month Follow-up|Total subjects with disease progressed at 36 months
524470|NCT00277524|O2|Outcome|24-month Follow-up|Total subjects with disease progressed at 24 months
524471|NCT00277524|O1|Outcome|12-month Follow-up|Total subjects with disease progressed at 12 months
524472|NCT00277524|O2|Outcome|"SCD-HeFT Programming"|OMNI “SCD-HeFT” definition: programming combinations that result in shock therapy only for arrhythmias at cycle lengths of <320 ms or faster and no therapy for arrhythmias at cycle lengths ≥320 ms.
524473|NCT00277524|O1|Outcome|"PainFREE Programming"|OMNI “PainFREE” definition: programming combinations that result in ATP therapy for VT at cycle lengths <320 ms. Programming at cycle lengths ≥320 ms were not mandated.
524474|NCT00277524|O1|Outcome|ATP During Charging|Patients who had an episode and were programmed with the ATP during charging feature.
524475|NCT00277524|O2|Outcome|Patients With History of AV Block|Patients with MVP enabled and follow up data available
524476|NCT00277524|O1|Outcome|Patients Without History of AV Block|Patients with MVP enabled and follow up data available
524477|NCT00277524|O2|Outcome|ICD (N=1029)|ICD Patients with MVP enabled and follow up data available
524478|NCT00277524|O1|Outcome|IPG (N=610)|IPG Patients with MVP enabled and follow up data available
524479|NCT00277524|O1|Outcome|ICD/CRT-D Group|Subjects implanted with ICD/CRT-D
524480|NCT00277524|O1|Outcome|IPG Group|Subjects implanted with IPG
524481|NCT00277524|O1|Outcome|Implanted Subjects|All patients enrolled in OMNI.
524482|NCT00277524|E1|Reported Event||The Medtronic OMNI Study is a post-market observational study conducted in the United States (US). Adverse events were not collected as a part of the OMNI study. Sites were instructed to report applicable events in the same manner as required for any commercially available device, through the Medical Device Reporting (MDR) process.
524483|NCT00277446|B1|Baseline|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524484|NCT00277446|P1|Participant Flow|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524485|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524486|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524487|NCT00277446|O1|Outcome|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524488|NCT00277446|E1|Reported Event|Soy Isoflavone Supplement|This is a single blind study in which each participant was evaluated at baseline and then after receiving 100 mg of Novasoy once daily for 4 weeks.
524489|NCT00277394|B3|Baseline|Total|Total of all reporting groups
524490|NCT00277394|B2|Baseline|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524491|NCT00277394|B1|Baseline|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524492|NCT00277394|P2|Participant Flow|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524493|NCT00277394|P1|Participant Flow|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524494|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524495|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524496|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524497|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524498|NCT00277394|O2|Outcome|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524499|NCT00277394|O1|Outcome|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524500|NCT00277394|E2|Reported Event|Heparin|Heparin 50 IU /kg followed by a total dose of 400 to 600 IU/kg/day divided into two SC injections daily.
524501|NCT00277394|E1|Reported Event|Innohep®|innohep® 175 anti-Xa IU/kg once daily
524502|NCT00277355|B3|Baseline|Total|Total of all reporting groups
524503|NCT00277355|B2|Baseline|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
524504|NCT00277355|B1|Baseline|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
524505|NCT00277355|P2|Participant Flow|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
524506|NCT00277355|P1|Participant Flow|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
524507|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization).
524508|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
524509|NCT00277355|O2|Outcome|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
524510|NCT00277355|O1|Outcome|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
524511|NCT00277355|E2|Reported Event|Matching Placebo Twice Daily|Matching placebo twice daily (minocycline to placebo 3:1 ratio randomization.
524512|NCT00277355|E1|Reported Event|Minocycline 100 mg Twice Daily|Minocycline 100 mg/twice daily (minocycline to placebo 3:1 ratio randomization).
524513|NCT00277212|B1|Baseline|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
524514|NCT00277212|P3|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524515|NCT00277212|P2|Participant Flow|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524516|NCT00277212|P1|Participant Flow|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
524517|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524518|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524519|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524520|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524521|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524522|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524523|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524524|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524525|NCT00277212|O1|Outcome|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
524526|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524527|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524528|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524529|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524530|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524531|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524532|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524533|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524534|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524535|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524536|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524537|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524538|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524539|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524540|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524541|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524542|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524543|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524544|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524545|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524546|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524547|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524548|NCT00277212|O2|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524549|NCT00277212|O1|Outcome|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524550|NCT00277212|E3|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks.
524551|NCT00277212|E2|Reported Event|Phase 2 Double-Blind Treatment: Lamotrigine + Placebo|Lamotrigine 100-200 mg/day, Placebo 0 mg/day: tablets, oral, once daily, Phase 2 - up to 52 weeks
524552|NCT00277212|E1|Reported Event|Phase 1: Single-Blind Treatment, Lamotrigine + Aripiprazole|Lamotrigine 100-200 mg/day, Aripiprazole 10-30 mg/day: tablets, oral, once daily, Phase 1 (all subjects) - up to 24 weeks
524553|NCT00277095|B1|Baseline|ProACT|Implantable device
524554|NCT00277095|P1|Participant Flow|Implantable Device|ProACT Implantable device for treatment of post-prostatectomy stress urinary incontinence in males.
524555|NCT00277095|O1|Outcome|Urine Loss ( in Grams)|24 hour pad weight(in grams) demonstrating 50% reduction in urine loss (in grams)over 18th month
524556|NCT00277095|E1|Reported Event|ProACT|Implantable device
524557|NCT00276861|B1|Baseline|Single Arm|
524558|NCT00276861|P1|Participant Flow|Oxaliplatin + Gemcitabine|
524559|NCT00276861|O1|Outcome|Oxaliplatin + Gemcitabine|
524560|NCT00276861|O1|Outcome|Single Arm|
524561|NCT00276861|E1|Reported Event|Single Arm|
524562|NCT00276614|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
524563|NCT00276614|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
524564|NCT00276614|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
524565|NCT00276614|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m2 given on days 1, 4, 8, 11 of a 21 day cycle.
524566|NCT00276549|B1|Baseline|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
524567|NCT00276549|P1|Participant Flow|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
524568|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
524569|NCT00276549|O1|Outcome|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
531612|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
524570|NCT00276549|E1|Reported Event|Gemcitabine (Gemzar) and Docetaxel (Taxotere)|Gemcitabine (Gemzar) 800 mg/m2 administered intravenously over 30 to 60 minutes on Day 1 and 8 of each treatment cycle and docetaxel (Taxotere) 75 mg/m2 administered intravenously over 30 to 60 minutes on Day 8 followed the Day 8 infusion of gemcitabine.
524571|NCT00276484|B3|Baseline|Total|Total of all reporting groups
524572|NCT00276484|B2|Baseline|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524573|NCT00276484|B1|Baseline|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524574|NCT00276484|P2|Participant Flow|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524575|NCT00276484|P1|Participant Flow|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524576|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524577|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524578|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524579|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524580|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524581|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524582|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524583|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524584|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524585|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524586|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524587|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524588|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524589|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524590|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524591|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524592|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524593|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524594|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524595|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524596|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524597|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524598|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524599|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524600|NCT00276484|O2|Outcome|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524601|NCT00276484|O1|Outcome|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524602|NCT00276484|E2|Reported Event|Atorvastatin|Atorvastatin 80 mg every day for 6 weeks
524603|NCT00276484|E1|Reported Event|Atorvastatin + Ezetemibe|Atorvastatin 40 mg + Ezetemibe 10 mg every day for 6 weeks
524604|NCT00276458|B3|Baseline|Total|Total of all reporting groups
524605|NCT00276458|B2|Baseline|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524606|NCT00276458|B1|Baseline|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524607|NCT00276458|P2|Participant Flow|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524608|NCT00276458|P1|Participant Flow|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524609|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524610|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524611|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524612|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524613|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524614|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524615|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524616|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524617|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524618|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524619|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524620|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524621|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524622|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524623|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524624|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524625|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524626|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524627|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524628|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524629|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524630|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524631|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524632|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524633|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524634|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524635|NCT00276458|O2|Outcome|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524636|NCT00276458|O1|Outcome|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524637|NCT00276458|E2|Reported Event|Atorvastatin|Atorvastatin 40 mg Daily for 6 weeks
524638|NCT00276458|E1|Reported Event|Atorvastatin + Ezetimibe|Atorvastatin 20 mg + Ezetemibe 10 mg daily for 6 weeks
524639|NCT00276419|B3|Baseline|Total|Total of all reporting groups
524640|NCT00276419|B2|Baseline|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
524641|NCT00276419|B1|Baseline|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524642|NCT00276419|P2|Participant Flow|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
524643|NCT00276419|P1|Participant Flow|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524644|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
524645|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524646|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
524647|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524648|NCT00276419|O2|Outcome|Diclofenac First, Then Placebo (Arm B)|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks, then placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks.
524649|NCT00276419|O1|Outcome|Placebo First, Then Diclofenac (Arm A)|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks, then compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524650|NCT00276419|E2|Reported Event|Diclofenac|Compounded topical Diclofenac cream applied to the skin three times daily for 10 weeks.
524651|NCT00276419|E1|Reported Event|Placebo|Placebo for Diclofenac in topical cream applied to the skin three times daily for 10 weeks
524652|NCT00276406|B3|Baseline|Total|Total of all reporting groups
524653|NCT00276406|B2|Baseline|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524654|NCT00276406|B1|Baseline|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524655|NCT00276406|P2|Participant Flow|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524656|NCT00276406|P1|Participant Flow|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524657|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524658|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524659|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524660|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524661|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524662|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524663|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524664|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524665|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524666|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524667|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524668|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
531613|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
524669|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524670|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524671|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524672|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524673|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524674|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524675|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524676|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524677|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524678|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524679|NCT00276406|O2|Outcome|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524680|NCT00276406|O1|Outcome|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524681|NCT00276406|E2|Reported Event|Placebo|Placebo (sham) capsules, matching the appearance of the active drug comparator and taken tid.
524682|NCT00276406|E1|Reported Event|Pyridostigmine|Oral pyridostigmine, starting with 60 mg capsules three times per day (tid), increasing by 60 mg every third day (i.e., over 10 days) up to the maximum tolerated dose or 120 mg tid (a total of 360 mg per day). This dose was maintained for 7 days.
524683|NCT00276250|B4|Baseline|Total|Total of all reporting groups
524684|NCT00276250|B3|Baseline|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524685|NCT00276250|B2|Baseline|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524686|NCT00276250|B1|Baseline|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524687|NCT00276250|P3|Participant Flow|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524688|NCT00276250|P2|Participant Flow|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524689|NCT00276250|P1|Participant Flow|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524690|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524691|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524692|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524693|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524694|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524695|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524696|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524697|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524698|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524699|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524700|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524701|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524702|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524703|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524704|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524705|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524706|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524707|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524708|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524709|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524710|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524711|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524712|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524713|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524714|NCT00276250|O3|Outcome|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524715|NCT00276250|O2|Outcome|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524716|NCT00276250|O1|Outcome|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524717|NCT00276250|E3|Reported Event|Belatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received Belatacept immunosuppresion regimen after islet-cell transplantation.
524718|NCT00276250|E2|Reported Event|Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received abatacept immunosuppresion regimen after islet-cell transplantation.
524787|NCT00276016|P5|Participant Flow|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
531614|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
524719|NCT00276250|E1|Reported Event|Efalizumab Followed by Abatacept Regimen|Participants with Type 1 diabetes with onset of disease at < 40 years of age and insulin-dependence for > 5 years received efalizumab-based immunosuppression regimen after islet-cell transplantation. During the course of the study, efalizumab was withdrawn from the US market due to safety concerns. The protocol was subsequently amended to alter the immunosuppressive regimen to abatacept for these participants.
524720|NCT00276159|B1|Baseline|852A Treatment|Patients receiving at least 12 doses of 852A.
524721|NCT00276159|P1|Participant Flow|852A Treatment|Patients receiving at least 12 doses of 852A.
524722|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
524723|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
524724|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
524725|NCT00276159|O1|Outcome|852A Treatment|Patients receiving at least 12 doses of 852A.
524726|NCT00276159|E1|Reported Event|852A Treatment|Patients receiving at least 12 doses of 852A.
524727|NCT00276094|B4|Baseline|Total|Total of all reporting groups
524728|NCT00276094|B3|Baseline|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524729|NCT00276094|B2|Baseline|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524730|NCT00276094|B1|Baseline|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524731|NCT00276094|P3|Participant Flow|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524732|NCT00276094|P2|Participant Flow|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524733|NCT00276094|P1|Participant Flow|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524734|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524735|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524736|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524737|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524738|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524739|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524740|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524741|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524742|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524743|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524899|NCT00275262|B3|Baseline|Total|Total of all reporting groups
524744|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524745|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524746|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524747|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524748|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524749|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524750|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524751|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524752|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524753|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524754|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524755|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524756|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524757|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524758|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524759|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524760|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524761|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524762|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524763|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524764|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524765|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524766|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524767|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524768|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524769|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524770|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524771|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524772|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524773|NCT00276094|O3|Outcome|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524774|NCT00276094|O2|Outcome|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524775|NCT00276094|O1|Outcome|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524776|NCT00276094|E3|Reported Event|Placebo Tablets and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of placebo each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524777|NCT00276094|E2|Reported Event|Ospemifene 60 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 60 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524778|NCT00276094|E1|Reported Event|Ospemifene 30 mg/Day and Nonhormonal Vaginal Lubricant|Subjects received a single dose (1 tablet) of ospemifene 30 mg each morning with food for 12 weeks. The vaginal lubricant (K-Y® Brand Jelly) was applied as needed and its use was recorded in the medication diary. The first dose of the study drug was administered at the clinic at Visit 2.
524779|NCT00276016|B7|Baseline|Total|Total of all reporting groups
524780|NCT00276016|B6|Baseline|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
524781|NCT00276016|B5|Baseline|Pseudoephedrine, Phenylephrine, Placebo|"Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release~12 mg capsules for oral administration. Placebo: Placebo capsules."
524782|NCT00276016|B4|Baseline|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
524783|NCT00276016|B3|Baseline|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
524784|NCT00276016|B2|Baseline|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
524785|NCT00276016|B1|Baseline|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
524786|NCT00276016|P6|Participant Flow|Placebo, Pseudoephedrine, Phenylephrine|Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration
524788|NCT00276016|P4|Participant Flow|Phenylephrine, Placebo, Pseudoephedrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
524789|NCT00276016|P3|Participant Flow|Placebo, Phenylephrine, Pseudoephedrine|Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
524790|NCT00276016|P2|Participant Flow|Pseudoephedrine, Placebo, Phenylephrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
524791|NCT00276016|P1|Participant Flow|Phenylephrine, Pseudoephedrine, Placebo|Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules
524792|NCT00276016|O2|Outcome|Placebo|
524793|NCT00276016|O1|Outcome|Pseudoephedrine|
524794|NCT00276016|O2|Outcome|Phenylephrine|
524795|NCT00276016|O1|Outcome|Placebo|
524796|NCT00276016|E3|Reported Event|Placebo|Placebo: Placebo capsules.
524797|NCT00276016|E2|Reported Event|Pseudoephedrine|Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
524798|NCT00276016|E1|Reported Event|Phenylephrine|Phenylephrine: Immediate-release 12 mg capsules for oral administration.
524799|NCT00275834|B4|Baseline|Total|Total of all reporting groups
524800|NCT00275834|B3|Baseline|Zonisamide 400 mg|
524801|NCT00275834|B2|Baseline|Zonisamide 200 mg|
524802|NCT00275834|B1|Baseline|Placebo|
524803|NCT00275834|P3|Participant Flow|Zonisamide 400 mg|
524804|NCT00275834|P2|Participant Flow|Zonisamide 200 mg|Dosing of matching placebo was identical.
524805|NCT00275834|P1|Participant Flow|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
524806|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524807|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
524808|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
524809|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524810|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524811|NCT00275834|O1|Outcome|Placebo|
524812|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524813|NCT00275834|O2|Outcome|Zonisamide 200 mg|Dosing of matching placebo was identical.
524814|NCT00275834|O1|Outcome|Placebo|"Zonisamide 100 mg and placebo capsules were prepared in accordance with Good Manufacturing Practice (GMP) guidelines in Duke Compounding Facility with active pharmaceutical ingredient (Sochinaz SA, Switzerland, distributed by Bachem Americas, King of Prussia, Pennsylvania) plus dextrose as an inactive ingredient. Identical-looking placebo capsules contained dextrose.~Each capsule contained zonisamide 100 mg or placebo, with patients and study staff blinded to contents. Dose was gradually titrated upward as follows: 1 capsule for 15 days, 2 during days 16-30, 3 capsules during days 31-45, and 4 from day 46 onward. The entire dose was taken at night. Blinded dose reduction was allowed and dose increase could be withheld. Patients had the option to discontinue the drug and remain in the study receiving only diet and lifestyle counseling."
524815|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524816|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524817|NCT00275834|O1|Outcome|Placebo|
524818|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524819|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524820|NCT00275834|O1|Outcome|Placebo|
524821|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524822|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524823|NCT00275834|O1|Outcome|Placebo|
524824|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524825|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524826|NCT00275834|O1|Outcome|Placebo|
524827|NCT00275834|O3|Outcome|Zonisamide 400 mg|
524828|NCT00275834|O2|Outcome|Zonisamide 200 mg|
524829|NCT00275834|O1|Outcome|Placebo|
524830|NCT00275834|E3|Reported Event|Zonisamide 400 mg|
524831|NCT00275834|E2|Reported Event|Zonisamide 200 mg|
524832|NCT00275834|E1|Reported Event|Placebo|
524833|NCT00275821|B4|Baseline|Total|Total of all reporting groups
524834|NCT00275821|B3|Baseline|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524835|NCT00275821|B2|Baseline|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524900|NCT00275262|B2|Baseline|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524836|NCT00275821|B1|Baseline|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524837|NCT00275821|P3|Participant Flow|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524838|NCT00275821|P2|Participant Flow|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524839|NCT00275821|P1|Participant Flow|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524840|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524841|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524842|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524843|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524844|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524845|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524846|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524847|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524848|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524849|NCT00275821|O3|Outcome|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524850|NCT00275821|O2|Outcome|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524851|NCT00275821|O1|Outcome|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524852|NCT00275821|E3|Reported Event|Ranibizumab 0.3 mg Monthly|Subjects received monthly intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524853|NCT00275821|E2|Reported Event|Ranibizumab 0.5 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.5 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524901|NCT00275262|B1|Baseline|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524902|NCT00275262|P2|Participant Flow|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524854|NCT00275821|E1|Reported Event|Ranibizumab 0.3 mg - 3 Times Monthly, Then Quarterly|Subjects received intravitreal injections (in the study eye) of ranibizumab 0.3 mg over a duration of 12 months. They were treated monthly for 3 consecutive months and then quarterly for the remainder of the study. On those months when ranibizumab was not administered, patients received a sham injection to preserve the masking of the treatment arms.
524855|NCT00275561|B3|Baseline|Total|Total of all reporting groups
524856|NCT00275561|B2|Baseline|Placebo|Placebo inhaler swallowed bid for 6 weeks
524857|NCT00275561|B1|Baseline|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524858|NCT00275561|P2|Participant Flow|Placebo|Placebo inhaler swallowed bid for 6 weeks
524859|NCT00275561|P1|Participant Flow|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524860|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
524861|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524862|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
524863|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524864|NCT00275561|O2|Outcome|Placebo|Placebo inhaler swallowed bid for 6 weeks
524865|NCT00275561|O1|Outcome|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524866|NCT00275561|E2|Reported Event|Placebo|Placebo inhaler swallowed bid for 6 weeks
524867|NCT00275561|E1|Reported Event|Fluticasone|Aerosolized swallowed fluticasone 880 mcg bid for 6 weeks
524868|NCT00275392|B3|Baseline|Total|Total of all reporting groups
524869|NCT00275392|B2|Baseline|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
524870|NCT00275392|B1|Baseline|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
524871|NCT00275392|P2|Participant Flow|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
524872|NCT00275392|P1|Participant Flow|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
524873|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
524874|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
524875|NCT00275392|O2|Outcome|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
524876|NCT00275392|O1|Outcome|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
524877|NCT00275392|E2|Reported Event|Placebo|"placebo exercises plus standard balance and gait exercises~Placebo Vestibular rehabilitation: placebo vestibular exercises"
524878|NCT00275392|E1|Reported Event|Vestibular Rehabilitation|"vestibular exercises plus standard balance and gait exercises~Vestibular rehabilitation: vestibular adaptation and substitution exercises"
524879|NCT00275340|B3|Baseline|Total|Total of all reporting groups
524880|NCT00275340|B2|Baseline|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
524881|NCT00275340|B1|Baseline|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
524882|NCT00275340|P2|Participant Flow|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
524883|NCT00275340|P1|Participant Flow|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
524884|NCT00275340|O2|Outcome|Peer Support|In addition to usual care, patients randomly assigned to peer support received individualized pain management and exercise education via home-based peer support delivered by telephone.
524885|NCT00275340|O1|Outcome|Usual Care|Patients allocated to usual care received the standard education/support offered to patients post coronary artery bypass graft surgery: preoperative/postoperative group education, preoperative video, general information booklet and preoperative/postoperative visits from in-hospital peer volunteers.
524886|NCT00275275|B4|Baseline|Total|Total of all reporting groups
524887|NCT00275275|B3|Baseline|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
524888|NCT00275275|B2|Baseline|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
524889|NCT00275275|B1|Baseline|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
524890|NCT00275275|P3|Participant Flow|Mirapex to Requip 24-Hour of 1:5|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:5
524891|NCT00275275|P2|Participant Flow|Mirapex to Requip 24-Hour of 1:4|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:4
524892|NCT00275275|P1|Participant Flow|Mirapex to Requip 24-Hour of 1:3|Conversion factor of Mirapex to Ropinirole 24-Hour of 1:3
524893|NCT00275275|O2|Outcome|Preferred Mirapex|This is the group that preferred Mirapex to Requip PR
524894|NCT00275275|O1|Outcome|Preferred Requip PR|This is the group of subjects that preferred Requip PR to Mirapex
524895|NCT00275275|O2|Outcome|Preferred Mirapex|This group refers to the subjects that preferred Mirapex
524896|NCT00275275|O1|Outcome|Preferred Requip PR|This group refers to the subjects that preferred Requip PR to Mirapex
524897|NCT00275275|E2|Reported Event|Preferred Mirapex|These are the subjects that preferred Mirapex to Requip PR at the end of the study
524898|NCT00275275|E1|Reported Event|Preferred Requip PR|These are the subjects that preferred Requip PR to Mirapex at the end of the study
524903|NCT00275262|P1|Participant Flow|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524904|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524905|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524906|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524907|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524908|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524909|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524910|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524911|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524912|NCT00275262|O2|Outcome|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524913|NCT00275262|O1|Outcome|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524914|NCT00275262|E2|Reported Event|Placebo|Patients received 1 injection of placebo every 3 months for a total treatment period of 9 months.
524915|NCT00275262|E1|Reported Event|Leuprolide Acetate Depot (LAD) 11.25 mg 3 Month|Patients received 1 injection of LAD 11.25 mg every 3 months for a total treatment period of 9 months.
524916|NCT00275028|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
524917|NCT00275028|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
524918|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
524919|NCT00275028|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
524920|NCT00275028|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
524921|NCT00275002|B3|Baseline|Total|Total of all reporting groups
524922|NCT00275002|B2|Baseline|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524923|NCT00275002|B1|Baseline|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524924|NCT00275002|P2|Participant Flow|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524925|NCT00275002|P1|Participant Flow|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524926|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524927|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524928|NCT00275002|O2|Outcome|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524975|NCT00274742|B5|Baseline|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
524929|NCT00275002|O1|Outcome|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524930|NCT00275002|E2|Reported Event|Recurrent Brain Stem Tumors|Participants with recurrent or progressive brain stem tumors receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524931|NCT00275002|E1|Reported Event|Recurrent High-Grade Gliomas|Participants with recurrent or progressive high-grade gliomas receive 120 mg/m^2 of O6-Benzylguanine administered as a one-hour intravenous infusion, daily for 5 days. Temozolomide, 75 mg/m^2 is administered orally, 30 minutes following the completion of each infusion of O6-Benzylguanine. Four consecutive weeks will constitute one course, and courses will be repeated every 4 weeks.
524932|NCT00274937|B1|Baseline|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
524933|NCT00274937|P1|Participant Flow|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
524934|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
524935|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
524936|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
524937|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
524938|NCT00274937|O1|Outcome|Stratum II|AJCC Stage IIb - IV
524939|NCT00274937|O1|Outcome|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
524940|NCT00274937|E1|Reported Event|Stratum II (Chemotherapy, Chemoprotective Agent, Radiotherapy)|"Patients receive cisplatin IV over 6 hours on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3 weeks for 3 courses. In weeks 10-18, patients undergo radiation therapy and receive amifostine trihydrate as in stratum I. Patients also receive 3 courses of cisplatin as before.~amifostine trihydrate: Given subcutaneously~fluorouracil: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies~radiation therapy: Undergo radiotherapy"
524941|NCT00274924|B4|Baseline|Total|Total of all reporting groups
524942|NCT00274924|B3|Baseline|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
524943|NCT00274924|B2|Baseline|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
524944|NCT00274924|B1|Baseline|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
524945|NCT00274924|P3|Participant Flow|No Mid-Treatment PET|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who did not have mid-treatment PET scan for any reasons came off study and continued to be followed up for disease progression and survival.
524946|NCT00274924|P2|Participant Flow|Group II (PET Negative)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
524972|NCT00274768|E1|Reported Event|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
524973|NCT00274742|B7|Baseline|Total|Total of all reporting groups
524974|NCT00274742|B6|Baseline|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524947|NCT00274924|P1|Participant Flow|Group I (PET Positive)|Initially, patients received Rituximab 375 mg/m2 IV Day 1, Cyclophosphamide 750 mg/m2 IV Day 1, Vincristine 1.4 mg/m2 (max: 2 mg) IV Day 1, Doxorubicin 50 mg/m2 IV Day 1, and Prednisone 100 mg/m2 PO Days 1-5 (R-CHOP) every 21 days for 4 cycles. PET scan and conventional restaging occurred between days 14-20 of cycle 3. Patients who were PET positive after 3 cycles of R-CHOP received Rituximab 375 mg/m2 IV Day 1, Ifosfamide 5000 mg/m2 IV over 24 hours Day 2, Carboplatin AUC 5 (max: 800 mg) IV Day 2, Etoposide 100 mg/m2 IV Days 1, 2, 3 (R-ICE), Mesna 5000 mg/m2 IV over 24 hours Day 2, and Filgrastim 5 mcg/kg/day subcutaneous (SC) Day 4 until absolute neutrophil count (ANC) recovery every 14 days for 4 cycles .
524948|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
524949|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
524950|NCT00274924|O2|Outcome|Group II (PET Positive)|Eligible and treated patients who were PET positive after 3 cycles of R-CHOP received 4 cycles of R-ICE.
524951|NCT00274924|O1|Outcome|Group I (PET Negative)|Eligible and treated patients who were PET negative after 3 cycles of R-CHOP received 2 more cycles of R-CHOP (6 cycles in total).
524952|NCT00274924|E3|Reported Event|Step 2 - Mid-treatment PET Negative|Patients who were mid-treatment PET negative and who received additional R-CHOP in step 2 regardless of eligibility.
524953|NCT00274924|E2|Reported Event|Step 2 - Mid-treatment PET Positive|Patients who were mid-treatment PET positive and who received R-ICE in step 2 regardless of eligibility.
524954|NCT00274924|E1|Reported Event|Step 1 - All Treated Patients|All treated patients regardless of eligibility.
524955|NCT00274846|B1|Baseline|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
524956|NCT00274846|P1|Participant Flow|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
524957|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
524958|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
524959|NCT00274846|O1|Outcome|Patients Achieving Complete Remission - Responders|Patients who achieved complete remission (CR) as judged by morphological criteria; only these patients can be judged for time to relapse.
524960|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
524961|NCT00274846|O1|Outcome|Patients With Relapsed/Refractory AML - Evaluable Group|Patients who are evaluable; received adequate (dose of 1.5-8 x 10^7/kg natural killer (NK) cells 14 days after treatment with chemotherapy and allogeneic NK cell-enriched immune therapy.
524962|NCT00274846|E1|Reported Event|Patients With Relapsed/Refractory Acute Myeloid Leukemia|Patients who met study criteria - relapsed or refractory acute myelogenous leukemia - and were enrolled.
524963|NCT00274781|B1|Baseline|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
524964|NCT00274781|P1|Participant Flow|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
524965|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
524966|NCT00274781|O1|Outcome|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
524967|NCT00274781|O1|Outcome|ATO + GO|"Arsenic Trioxide 0.25 mg/kg D1-5 Week 1/Twice Weekly W2-12 + Gemtuzumab Ozogamicin 3 mg/m^2 D8 for 1 or 2 Cycles of 12 Weeks each~arsenic trioxide: Arsenic trioxide will be administered at a dose of 0.25 mg/kg/day IV over 1-2 hours for 5 consecutive days during the first week. Subsequently, arsenic trioxide will be given at a dose of 0.25mg/kg/day twice a week for 11 additional weeks (weeks 2-12).~gemtuzumab ozogamicin: Gemtuzumab ozogamicin consists of a 2 hr infusion at a dose of 3mg/m2 on day 8 of each 12-week cycle. Gemtuzumab ozogamicin should be administered at a minimum of one hour after the completion of the arsenic trioxide infusion"
524968|NCT00274781|E1|Reported Event|ATO (0.25mg/kg) and GO (3mg/m2)|ATO dosing was based on the phase 2 European Union regimen at a dose of 0.25 mg/kg administered intravenously on Days 1 through 5 during Week 1 and then twice weekly during Weeks 2 to 12, and GO at a dose of 3mg/m2 on Day 8 for 1 or 2 cycles of 12 weeks each.
524969|NCT00274768|B1|Baseline|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
524970|NCT00274768|P1|Participant Flow|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
524971|NCT00274768|O1|Outcome|Capecitabine|The starting dose of capecitabine was 3,000 mg (total daily dose) given in two divided daily doses for 14 days followed by 7 days of rest (1 cycle = 21 days). Missed doses were not substituted. Treatment was continued until unacceptable toxicity, disease progression, or withdrawal of consent.
525049|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
524976|NCT00274742|B4|Baseline|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524977|NCT00274742|B3|Baseline|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524978|NCT00274742|B2|Baseline|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524979|NCT00274742|B1|Baseline|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524980|NCT00274742|P6|Participant Flow|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524981|NCT00274742|P5|Participant Flow|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
524982|NCT00274742|P4|Participant Flow|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524983|NCT00274742|P3|Participant Flow|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524984|NCT00274742|P2|Participant Flow|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524985|NCT00274742|P1|Participant Flow|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524986|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524987|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
524988|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524989|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524990|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524991|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524992|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524993|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
524994|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524995|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524996|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524997|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
524998|NCT00274742|O5|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
524999|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d|Participants received blinatumomab 60 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
525000|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion in hte first treatment cycle.
525001|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants who received blinatumomab 15 µg/m²/day as continuous intravenous infusion in the first treatment cyle.
525002|NCT00274742|O1|Outcome|Blinatumomab 5 µg/m²/d|Participants who received blinatumomab 5 µg/m²/day as continuous intravenous infusion in the first treatment cycle.
525003|NCT00274742|O6|Outcome|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525004|NCT00274742|O5|Outcome|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
525005|NCT00274742|O4|Outcome|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525006|NCT00274742|O3|Outcome|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525007|NCT00274742|O2|Outcome|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525008|NCT00274742|O1|Outcome|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525009|NCT00274742|E7|Reported Event|Blinatumomab Overall|All participants who received any dose of blinatumomab
525010|NCT00274742|E6|Reported Event|Blinatumomab 90 µg/m²/d|Participants received blinatumomab 90 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
531615|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
525011|NCT00274742|E5|Reported Event|Blinatumomab 60 µg/m²/d Step|Participants received blinatumomab 60 μg/m²/day as continuous intravenous infusion after initial lower doses of 5 and/or 15 μg/m²/day for a total treatment duration of 4-8 weeks in the first treatment cycle.
525012|NCT00274742|E4|Reported Event|Blinatumomab 60 µg/m²/d Flat|Participants received blinatumomab 60 µg/m²/day without a lower dose as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525013|NCT00274742|E3|Reported Event|Blinatumomab 30 µg/m²/d|Participants received blinatumomab 30 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525014|NCT00274742|E2|Reported Event|Blinatumomab 15 µg/m²/d|Participants received blinatumomab 15 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525015|NCT00274742|E1|Reported Event|Blinatumomab ≤ 5 µg/m²/d|Participants received blinatumomab ≤ 5 µg/m²/day as continuous intravenous infusion over 4-8 weeks in the first treatment cycle.
525016|NCT00274716|B7|Baseline|Total|Total of all reporting groups
525017|NCT00274716|B6|Baseline|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525018|NCT00274716|B5|Baseline|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525019|NCT00274716|B4|Baseline|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525020|NCT00274716|B3|Baseline|High BMI:MK-0916 6mg→MK-0916 6mg|Participants who received MK-0916 6 mg in Phase A and continued on MK-0916 6 mg for 12 weeks in Phase B
525021|NCT00274716|B2|Baseline|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525022|NCT00274716|B1|Baseline|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525023|NCT00274716|P6|Participant Flow|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525024|NCT00274716|P5|Participant Flow|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525025|NCT00274716|P4|Participant Flow|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525026|NCT00274716|P3|Participant Flow|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525027|NCT00274716|P2|Participant Flow|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525028|NCT00274716|P1|Participant Flow|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525029|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525030|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525031|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525032|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525033|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525034|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525035|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525036|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525037|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525038|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525039|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525040|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525041|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525042|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525043|NCT00274716|O4|Outcome|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525044|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525045|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525046|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525047|NCT00274716|O6|Outcome|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525048|NCT00274716|O5|Outcome|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525156|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525050|NCT00274716|O3|Outcome|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525051|NCT00274716|O2|Outcome|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525052|NCT00274716|O1|Outcome|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525053|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525054|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525055|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525056|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525057|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525058|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525059|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525060|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525061|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525062|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525063|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525064|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525065|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525066|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525067|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525068|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525069|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525070|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525071|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525072|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525073|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525074|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525075|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525076|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525077|NCT00274716|O4|Outcome|Placebo High BMI|Participants administered placebo tablet once daily for 12 weeks
525078|NCT00274716|O3|Outcome|MK-0916 6.0 mg High BMI|Participants administered MK-0916 6.0 mg tablet once daily for 12 weeks
525079|NCT00274716|O2|Outcome|MK-0736 7.0 mg High BMI|Participants administered MK-0736 7.0 mg tablet once daily for 12 weeks
525080|NCT00274716|O1|Outcome|MK-0736 2.0 mg High BMI|Participants administered MK-0736 2.0 mg tablet once daily for 12 weeks
525081|NCT00274716|E6|Reported Event|Low BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525082|NCT00274716|E5|Reported Event|Low BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525083|NCT00274716|E4|Reported Event|High BMI:Placebo→Placebo|Participants administered placebo tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525084|NCT00274716|E3|Reported Event|High BMI:MK-0916 6mg→MK-0916 6mg|Participants administered MK-0916 6mg tablet once daily in both Phase A (12 weeks) and Phase B (12 weeks)
525085|NCT00274716|E2|Reported Event|High BMI:MK-0736 7mg→Placebo|Participants administered MK-0736 7mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525086|NCT00274716|E1|Reported Event|High BMI:MK-0736 2mg→Placebo|Participants administered MK-0736 2mg tablet once daily for 12 weeks (Phase A) then administered placebo once daily for 12 weeks (Phase B)
525087|NCT00274651|B3|Baseline|Total|Total of all reporting groups
525088|NCT00274651|B2|Baseline|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525089|NCT00274651|B1|Baseline|CTCL (ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525090|NCT00274651|P2|Participant Flow|Arm B (PTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
525091|NCT00274651|P1|Participant Flow|Arm A (CTCL, ITT Population)|PXD101 1000 mg/m2 once daily for 5 days every 21 days
525092|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525093|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525094|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525095|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525096|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525097|NCT00274651|O2|Outcome|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525098|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525099|NCT00274651|O1|Outcome|PTCL (ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525100|NCT00274651|O1|Outcome|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525101|NCT00274651|E2|Reported Event|Arm B (PTCL, ITT Population)|"PTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525102|NCT00274651|E1|Reported Event|Arm A (CTCL, ITT Population)|"CTCL patients will receive 1000 mg/m2 of PXD101 IV~belinostat: 1000 mg/m2 for 5 days every 21 days; IV"
525103|NCT00274625|B3|Baseline|Total|Total of all reporting groups
525104|NCT00274625|B2|Baseline|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
525105|NCT00274625|B1|Baseline|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
525106|NCT00274625|P2|Participant Flow|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
525107|NCT00274625|P1|Participant Flow|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
525108|NCT00274625|O2|Outcome|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
525109|NCT00274625|O1|Outcome|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
525110|NCT00274625|E2|Reported Event|Suture Closure|Control : Incision is closed without the placement of a graft material (standard of care control)
525111|NCT00274625|E1|Reported Event|Surgisis Gold|Surgisis Gold Graft is placed as an underlay following open bariatric surgery.
525112|NCT00274469|B3|Baseline|Total|Total of all reporting groups
525113|NCT00274469|B2|Baseline|Anastrozole 1 mg|Anastrozole 1 mg
525114|NCT00274469|B1|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg
525115|NCT00274469|P2|Participant Flow|Anastrozole 1 mg|Anastrozole 1 mg
525116|NCT00274469|P1|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg
525117|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
525118|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
525119|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
525120|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
525121|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
525122|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
525123|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
525124|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
525125|NCT00274469|O2|Outcome|Anastrozole 1 mg|Anastrozole 1 mg
525126|NCT00274469|O1|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg
525127|NCT00274469|E2|Reported Event|Anastrozole 1 mg|Anastrozole 1 mg
525128|NCT00274469|E1|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg
525129|NCT00274456|B5|Baseline|Total|Total of all reporting groups
525130|NCT00274456|B4|Baseline|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525131|NCT00274456|B3|Baseline|ABI-007 150 mg/m^2|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest.
525132|NCT00274456|B2|Baseline|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525133|NCT00274456|B1|Baseline|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525134|NCT00274456|P4|Participant Flow|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525135|NCT00274456|P3|Participant Flow|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525136|NCT00274456|P2|Participant Flow|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525137|NCT00274456|P1|Participant Flow|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525138|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525139|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525140|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525141|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525142|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525143|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525144|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525145|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525146|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525147|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525148|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525149|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525150|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525151|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525152|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525153|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525154|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525155|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525157|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525158|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525159|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525160|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525161|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525162|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525163|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525164|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525165|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525166|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525167|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525168|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525169|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525170|NCT00274456|O4|Outcome|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525171|NCT00274456|O3|Outcome|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525172|NCT00274456|O2|Outcome|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525173|NCT00274456|O1|Outcome|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525174|NCT00274456|E4|Reported Event|Docetaxel 100 mg/m^2 q3w|Docetaxel (Taxotere) 100 mg/m^2 administered once every third week (q3w).
525175|NCT00274456|E3|Reported Event|ABI-007 150 mg/m^2 Weekly|ABI-007 150 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525176|NCT00274456|E2|Reported Event|ABI-007 100 mg/m^2 Weekly|ABI-007 100 mg/m^2 once weekly for 3 weeks followed by 1 week of rest
525177|NCT00274456|E1|Reported Event|ABI-007 300 mg/m^2 q3w|ABI-007 300 mg/m^2 administered once every third week (q3w).
525178|NCT00274287|B1|Baseline|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
525179|NCT00274287|P1|Participant Flow|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
525180|NCT00274287|O1|Outcome|GM-CSF (Leukine)|Taxotere is given at 75 mg/m2 on day 1 intravenously over 60 minutes with appropriate and standard pre-medications. Patients are eligible to receive growth factor support with G-CSF or Neulasta on day 2 at the investigator's discretion.
525181|NCT00274287|E1|Reported Event|GM-CSF (Leukine)|Once patients have finished receiving the chemotherapy and no signs of disease progression they may receive GMCSF (Leukine) as outlined in the protocol. 250 micro grams/m2 daily for two weeks followed by two weeks of rest.
525182|NCT00274261|B3|Baseline|Total|Total of all reporting groups
525183|NCT00274261|B2|Baseline|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
525184|NCT00274261|B1|Baseline|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
525185|NCT00274261|P2|Participant Flow|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
525186|NCT00274261|P1|Participant Flow|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
525187|NCT00274261|O2|Outcome|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
525188|NCT00274261|O1|Outcome|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
525189|NCT00274261|E2|Reported Event|Conceptrol|Conceptrol® Vaginal gel contains 100mg (4% concentration) of nonoxynol-9 (N-9) in 2.5mL volume of gel.
525190|NCT00274261|E1|Reported Event|C31G|C31G vaginal gel contains 35mg (1% concentration) of C31G in 3.5 mL volume of gel
525191|NCT00273910|B7|Baseline|Total|Total of all reporting groups
525192|NCT00273910|B6|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525193|NCT00273910|B5|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525194|NCT00273910|B4|Baseline|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
525195|NCT00273910|B3|Baseline|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525196|NCT00273910|B2|Baseline|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525197|NCT00273910|B1|Baseline|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525222|NCT00273858|B1|Baseline|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525198|NCT00273910|P6|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525199|NCT00273910|P5|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525200|NCT00273910|P4|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
525201|NCT00273910|P3|Participant Flow|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525202|NCT00273910|P2|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525203|NCT00273910|P1|Participant Flow|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525204|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525205|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525206|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
525207|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525208|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525209|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525210|NCT00273910|O6|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525211|NCT00273910|O5|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525212|NCT00273910|O4|Outcome|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
525213|NCT00273910|O3|Outcome|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525214|NCT00273910|O2|Outcome|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525215|NCT00273910|O1|Outcome|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525216|NCT00273910|E6|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525217|NCT00273910|E5|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (2 Syringe)|gp100:209-217(210M) peptide emulsified in Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525218|NCT00273910|E4|Reported Event|Adj-3 A2 gp209(2M) in Saline ID + Imiquimod|gp100:209-217(210M) peptide in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of the injection daily for 5 days.
525219|NCT00273910|E3|Reported Event|Adj-3 A2 gp209(2M) in Saline ID|gp100:209-217(210M) in 0.9% Sodium Chloride Injection injected intradermally on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525220|NCT00273910|E2|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ + Imiquimod (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks); following the injection patients will apply imiquimod to the skin at the site of injection daily for 5 days.
525221|NCT00273910|E1|Reported Event|Adj-3 A2 gp209(2M) in IFA SQ (Vortex)|gp100:209-217(210M) peptide emulsified in MONTANIDE ISA-51 or Montanide ISA 51 VG injected subcutaneously on day one every three weeks (1 cycle) for a total of twelve cycles (33 weeks).
525223|NCT00273858|P1|Participant Flow|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525224|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525225|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525226|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525227|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525228|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525229|NCT00273858|O1|Outcome|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525230|NCT00273858|E1|Reported Event|Etanercept|Etanercept administered subcutaneously (s.c.) at a dose of 25 milligram (mg) twice weekly or 50 mg once weekly for 24 months.
525231|NCT00273793|B7|Baseline|Total|Total of all reporting groups
525232|NCT00273793|B6|Baseline|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
525233|NCT00273793|B5|Baseline|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
525234|NCT00273793|B4|Baseline|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
525235|NCT00273793|B3|Baseline|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
525236|NCT00273793|B2|Baseline|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
525237|NCT00273793|B1|Baseline|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
525238|NCT00273793|P6|Participant Flow|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
525239|NCT00273793|P5|Participant Flow|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
525240|NCT00273793|P4|Participant Flow|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
525241|NCT00273793|P3|Participant Flow|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
525242|NCT00273793|P2|Participant Flow|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
525243|NCT00273793|P1|Participant Flow|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
525244|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
525245|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
525246|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
525247|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
525248|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
525249|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
525250|NCT00273793|O6|Outcome|Non Contingent Incentives Are Available to Smokers With Early|
525251|NCT00273793|O5|Outcome|Fixed Value Incentives Are Used in Smokers With Early Success|
525252|NCT00273793|O4|Outcome|Ascending Incentive Values Used in Smokers With Early Success|
525253|NCT00273793|O3|Outcome|Non Contingent Incentives Available to Hard-to-Treat Smokers|
525254|NCT00273793|O2|Outcome|Fixed Criterion Intervention for Hard-to-Treat Smokers|
525255|NCT00273793|O1|Outcome|Shaping Intervention for Hard-to-Treat Smokers|
525256|NCT00273793|E6|Reported Event|Non Contingent Incentives Are Available to Smokers With Early|Non contingent incentives are available to Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are non-contingently delivered on a random basis.
525257|NCT00273793|E5|Reported Event|Fixed Value Incentives Are Used in Smokers With Early Success|fixed value incentives are used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that are fixed in value
525303|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525683|NCT00272311|O1|Outcome|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
525258|NCT00273793|E4|Reported Event|Ascending Incentives Values Used in Smokers With Early Success|Ascending incentives values used in Smokers with Early Success: Smokers who did deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives that escalate in value with each delivery.
525259|NCT00273793|E3|Reported Event|Non Contingent Incentives Available to Hard to Treat Smokers|Non contingent incentives available to hard to treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives non-contingently on a random basis.
525260|NCT00273793|E2|Reported Event|Fixed Criterion Intervention for Hard-to-treat Smokers|fixed criterion intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives for COs < 3 ppm.
525261|NCT00273793|E1|Reported Event|Shaping Intervention for Hard-to-treat Smokers|Shaping intervention for hard-to-treat smokers: Smokers who did not deliver a breath CO < 3 ppm in first five weekday sessions randomly assigned to receive incentives based upon a percentile schedule.
525262|NCT00273754|B3|Baseline|Total|Total of all reporting groups
525263|NCT00273754|B2|Baseline|Caffeine|Caffeine benzoate
525264|NCT00273754|B1|Baseline|Placebo|Normal Saline
525265|NCT00273754|P2|Participant Flow|Caffeine|Caffeine benzoate
525266|NCT00273754|P1|Participant Flow|Placebo|Normal Saline
525267|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525268|NCT00273754|O1|Outcome|Placebo|Normal Saline
525269|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525270|NCT00273754|O1|Outcome|Placebo|Normal Saline
525271|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525272|NCT00273754|O1|Outcome|Placebo|Normal Saline
525273|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525274|NCT00273754|O1|Outcome|Placebo|Normal Saline
525275|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525276|NCT00273754|O1|Outcome|Placebo|Normal Saline
525277|NCT00273754|O2|Outcome|Caffeine|Caffeine benzoate
525278|NCT00273754|O1|Outcome|Placebo|Normal Saline
525279|NCT00273754|E2|Reported Event|Caffeine|Caffeine benzoate
525280|NCT00273754|E1|Reported Event|Placebo|Normal Saline
525281|NCT00273182|B1|Baseline|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525282|NCT00273182|P1|Participant Flow|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525283|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525284|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525285|NCT00273182|O1|Outcome|All Subjects|Patients implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525286|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525287|NCT00273182|O1|Outcome|All Subjects|Patients successfully implanted with InSync Model 8040 (including post-market new implants of InSync Model 8040 and pre-market implants from the MIRACLE study), InSync III Model 8042 (including post-market new implants of InSync III Model 8042 and pre-market implants from the InSync III study), and post-market Medtronic CRT-D devices.
525288|NCT00273182|E1|Reported Event|All Patients|The analysis included data from all subjects enrolled in the InSync Registry study.
525289|NCT00273052|B3|Baseline|Total|Total of all reporting groups
525290|NCT00273052|B2|Baseline|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525291|NCT00273052|B1|Baseline|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525292|NCT00273052|P2|Participant Flow|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525293|NCT00273052|P1|Participant Flow|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525294|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525295|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525296|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525297|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525298|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525299|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525300|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525301|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525302|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525304|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525305|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525306|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525307|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525308|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525309|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525310|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525311|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525312|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525313|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525314|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525315|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525316|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525317|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525318|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525319|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525320|NCT00273052|O2|Outcome|Toprol XL|Metoprolol Succinate Extended Release 50 mg, 100 mg, and 200 mg Tablets QD (once daily)
525321|NCT00273052|O1|Outcome|Coreg CR|Carvedilol Phosphate Extended Release 20 mg, 40 mg, and 80 mg Capsules QD (once daily)
525322|NCT00273052|E2|Reported Event|Toprol XL|Results include only treatment emergent events.
525323|NCT00273052|E1|Reported Event|Coreg CR|Results include only treatment emergent events.
525324|NCT00272987|B4|Baseline|Total|Total of all reporting groups
525325|NCT00272987|B3|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525326|NCT00272987|B2|Baseline|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525327|NCT00272987|B1|Baseline|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525328|NCT00272987|P3|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525329|NCT00272987|P2|Participant Flow|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525330|NCT00272987|P1|Participant Flow|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525331|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525332|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525390|NCT00272961|B4|Baseline|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525333|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525334|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525335|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525336|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525337|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525338|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525339|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525340|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525341|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525342|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525343|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525344|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525345|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525346|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525684|NCT00272311|E5|Reported Event|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525685|NCT00272311|E4|Reported Event|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
525347|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525348|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525349|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525350|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525351|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525352|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525353|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525354|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525355|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525356|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525357|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525358|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525359|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525360|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525686|NCT00272311|E3|Reported Event|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
525687|NCT00272311|E2|Reported Event|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
525361|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525362|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525363|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525364|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525365|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525366|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525367|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525368|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525369|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525370|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525371|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525372|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525373|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525374|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525688|NCT00272311|E1|Reported Event|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
525689|NCT00272168|B3|Baseline|Total|Total of all reporting groups
525375|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525376|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525377|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525378|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525379|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525380|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525381|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525382|NCT00272987|O3|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525383|NCT00272987|O2|Outcome|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525384|NCT00272987|O1|Outcome|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525385|NCT00272987|E3|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 750 mg|Participants received an IV infusion of paclitaxel 80 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 3 tablets of lapatinib (750 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The lapatinib dose was systematically increased to 1000 mg after 2 cycles if the 750 mg dose was tolerated.
525386|NCT00272987|E2|Reported Event|Paclitaxel 70 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an IV infusion of paclitaxel 70 mg/m^2 over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg/kg loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal. The paclitaxel dose was systematically increased to 80 mg/m^2 after 2 cycles if 70 mg/m^2 was tolerated.
525387|NCT00272987|E1|Reported Event|Paclitaxel 80 mg/Trastuzumab 4 mg/Lapatinib 1000 mg|Participants received an intravenous (IV) infusion of paclitaxel 80 milligrams per meter squared (mg/m^2) over 60 minutes weekly for 3 weeks of a 4-week cycle plus an IV infusion of trastuzumab 4 mg per kilogram (mg/kg) loading dose and 2 mg/kg weekly plus a daily dose of 4 tablets of lapatinib (1000 mg) at approximately the same time every day, either 1 hour (or more) before a meal or 1 hour (or more) after a meal.
525388|NCT00272961|B6|Baseline|Total|Total of all reporting groups
525389|NCT00272961|B5|Baseline|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525744|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525391|NCT00272961|B3|Baseline|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525392|NCT00272961|B2|Baseline|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525393|NCT00272961|B1|Baseline|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525394|NCT00272961|P5|Participant Flow|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525395|NCT00272961|P4|Participant Flow|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525396|NCT00272961|P3|Participant Flow|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525397|NCT00272961|P2|Participant Flow|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525398|NCT00272961|P1|Participant Flow|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525399|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525400|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525401|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525402|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525403|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525404|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525405|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525406|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525407|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525408|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525409|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525410|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525411|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525412|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525413|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525436|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525414|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525415|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525416|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525417|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525418|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525419|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525420|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525421|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525422|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525423|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525424|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525425|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525426|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525427|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525428|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525429|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525430|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525431|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525432|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525433|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525434|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525435|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525665|NCT00272337|E3|Reported Event|3 of 5 Randomized Treatment Arms|325 mg Aspirin
525437|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525438|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525439|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525440|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525441|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525442|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525443|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525444|NCT00272961|O5|Outcome|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525445|NCT00272961|O4|Outcome|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525446|NCT00272961|O3|Outcome|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525447|NCT00272961|O2|Outcome|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525448|NCT00272961|O1|Outcome|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525449|NCT00272961|E5|Reported Event|TBC3711 200 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 1 week followed by 4 TBC3711 50 mg tablets (equivalent to TBC3711 200 mg) orally once daily for 8 weeks in 10-week Treatment Phase.
525450|NCT00272961|E4|Reported Event|TBC3711 100 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily for 1 week followed by 2 TBC3711 50 mg tablets (equivalent to TBC3711 100 mg) and 2 matching placebo tablets orally once daily for 9 weeks in 10-week Treatment Phase.
525451|NCT00272961|E3|Reported Event|TBC3711 50 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 50 mg tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525452|NCT00272961|E2|Reported Event|TBC3711 10 mg|Participants who received placebo matched to TBC3711 tablet orally once daily in 2-week Placebo Run-in Phase, received TBC3711 10 milligram (mg) tablet and 3 matching placebo tablets orally once daily in 10-week Treatment Phase.
525453|NCT00272961|E1|Reported Event|Placebo|Placebo matched to TBC3711, 4 tablets orally once daily in 2-week placebo run-in phase and 10-week treatment phase.
525454|NCT00272792|B3|Baseline|Total|Total of all reporting groups
525455|NCT00272792|B2|Baseline|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525456|NCT00272792|B1|Baseline|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525457|NCT00272792|P2|Participant Flow|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525458|NCT00272792|P1|Participant Flow|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525459|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525666|NCT00272337|E2|Reported Event|2 of 5 Randomized Treatment Arms|162 mg Aspirin
525460|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525461|NCT00272792|O2|Outcome|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525462|NCT00272792|O1|Outcome|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525463|NCT00272792|E2|Reported Event|Placebo|Placebo, provided as tablets similar to Phenoptin tablets, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4 8 oz (120–240 mL) of water or apple juice. for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525464|NCT00272792|E1|Reported Event|Sapropterin Dihydrochloride|Phenoptin, provided in tablets containing 100 mg of sapropterin dihydrochloride each, was administered orally once daily in the morning as the number of tablets equivalent to a 20mg/kg/day dose dissolved in 4-8 oz (120–240 mL) of water or apple juice for 6 weeks. A follow-up call or visit was made 4 weeks later during this double-blind, placebo-controlled study.
525465|NCT00272779|B3|Baseline|Total|Total of all reporting groups
525466|NCT00272779|B2|Baseline|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525467|NCT00272779|B1|Baseline|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525468|NCT00272779|P2|Participant Flow|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525469|NCT00272779|P1|Participant Flow|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525470|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525471|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525472|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525473|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525474|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525475|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525476|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525477|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525478|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525479|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525480|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525481|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525482|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525483|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525484|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525485|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525486|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525487|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525488|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525489|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525490|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525491|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525492|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525493|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525494|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525495|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525496|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525497|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525498|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525667|NCT00272337|E1|Reported Event|1 of 5 Randomized Treatment Arms|81 mg Aspirin
525668|NCT00272311|B6|Baseline|Total|Total of all reporting groups
525499|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525500|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525501|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525502|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525503|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525504|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525505|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525506|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525507|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525508|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525509|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525510|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525511|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525512|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525513|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525514|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525515|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525516|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525517|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525669|NCT00272311|B5|Baseline|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525670|NCT00272311|B4|Baseline|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
525518|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525519|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525520|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525521|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525522|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525523|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525524|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525525|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525526|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525527|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525528|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525529|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525530|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525531|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525532|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525533|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525534|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525535|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525536|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525671|NCT00272311|B3|Baseline|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
525672|NCT00272311|B2|Baseline|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
525537|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525538|NCT00272779|O1|Outcome|All Participants With Pharmacogenetic Blood Samples|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525539|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525540|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525541|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525542|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525543|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525544|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525545|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525546|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525547|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525548|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525549|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525550|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525551|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525552|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525553|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525554|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525555|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525673|NCT00272311|B1|Baseline|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
525674|NCT00272311|P5|Participant Flow|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525556|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525557|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525558|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525559|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525560|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525561|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525562|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525563|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525564|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525565|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525566|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525567|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525568|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525569|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525570|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525571|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525572|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525573|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525574|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525675|NCT00272311|P4|Participant Flow|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
525676|NCT00272311|P3|Participant Flow|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
525575|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525576|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525577|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525578|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525579|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525580|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525581|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525582|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525583|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525584|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525585|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525586|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525587|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525588|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525589|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525590|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525591|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525592|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525593|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525677|NCT00272311|P2|Participant Flow|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
525678|NCT00272311|P1|Participant Flow|Arm 1 of 5 Randomized Treatment Arms|81 mg Aspirin
525594|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525595|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525596|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525597|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525598|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525599|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525600|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525601|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525602|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525603|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525604|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525605|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525606|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525607|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525608|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525609|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525610|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525611|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525612|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525679|NCT00272311|O5|Outcome|Arm 5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525680|NCT00272311|O4|Outcome|Arm 4 of 5 Randomized Treatment Arms|650 mg Aspirin
525613|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525614|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525615|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525616|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525617|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525618|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525619|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525620|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525621|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525622|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525623|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525624|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525625|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525626|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525627|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525628|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525629|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525630|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525631|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525681|NCT00272311|O3|Outcome|Arm 3 of 5 Randomized Treatment Arms|325 mg Aspirin
525682|NCT00272311|O2|Outcome|Arm 2 of 5 Randomized Treatment Arms|162 mg Aspirin
525632|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525633|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525634|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525635|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525636|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525637|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525638|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525639|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525640|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525641|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525642|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525643|NCT00272779|O2|Outcome|LPV 400mg BID + RTV 100mg BID + TDF 300 mg QD + FTC 200 mg QD|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525644|NCT00272779|O1|Outcome|ATV 300 mg QD + RTV 100 mg QD + TDF 300 mg QD + FTC 200 mg QD|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525645|NCT00272779|E2|Reported Event|LPV/RTV/Tenofovir/Emtricitabine|Participants were administered lopinavir (LPV) 400 mg or ritonavir (RTV) 100 mg twice daily along with food. Doses were taken approximately 12 hours apart while tenofovir (TDF) 300 mg once daily and emtricitabine (FTC) 200 mg once daily was administered at the same time as 1 of the 2 daily doses of LPV/RTV.
525646|NCT00272779|E1|Reported Event|ATV/RTV/Tenofovir/Emtricitabine|Participants were administered an oral dose of Atazanavir (ATV) 300 mg and ritonavir (RTV) 100 mg once daily along with food. Doses were taken 24 hours apart at the same time as fixed dose combination tenofovir (TDF) 300 mg plus emtricitabine (FTC) 200 mg once daily.
525647|NCT00272337|B6|Baseline|Total|Total of all reporting groups
525648|NCT00272337|B5|Baseline|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525649|NCT00272337|B4|Baseline|4 of 5 Randomized Treatment Arms|650 mg Aspirin
525650|NCT00272337|B3|Baseline|3 of 5 Randomized Treatment Arms|325 mg Aspirin
525651|NCT00272337|B2|Baseline|2 of 5 Randomized Treatment Arms|162 mg Aspirin
525652|NCT00272337|B1|Baseline|1 of 5 Randomized Treatment Arms|81 mg Aspirin
525653|NCT00272337|P5|Participant Flow|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525654|NCT00272337|P4|Participant Flow|4 of 5 Randomized Treatment Arms|650 mg Aspirin
525655|NCT00272337|P3|Participant Flow|3 of 5 Randomized Treatment Arms|325 mg Aspirin
525656|NCT00272337|P2|Participant Flow|2 of 5 Randomized Treatment Arms|162 mg Aspirin
525657|NCT00272337|P1|Participant Flow|1 of 5 Randomized Treatment Arms|81 mg Aspirin
525658|NCT00272337|O5|Outcome|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525659|NCT00272337|O4|Outcome|4 of 5 Randomized Treatment Arms|650 mg Aspirin
525660|NCT00272337|O3|Outcome|3 of 5 Randomized Treatment Arms|325 mg Aspirin
525661|NCT00272337|O2|Outcome|2 of 5 Randomized Treatment Arms|162 mg Aspirin
525662|NCT00272337|O1|Outcome|1 of 5 Randomized Treatment Arms|81 mg Aspirin
525663|NCT00272337|E5|Reported Event|5 of 5 Randomized Treatment Arms|1300 mg Aspirin
525664|NCT00272337|E4|Reported Event|4 of 5 Randomized Treatment Arms|650 mg Aspirin
525690|NCT00272168|B2|Baseline|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525691|NCT00272168|B1|Baseline|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525692|NCT00272168|P2|Participant Flow|Arm 2: Control|"Supportive Treatment for Serious Mental Illness (control)~Supportive Treatment for Serious Mental Illness (SMI): Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525693|NCT00272168|P1|Participant Flow|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525694|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525695|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525696|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525697|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525698|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525699|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525700|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525701|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525702|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525703|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525704|NCT00272168|O2|Outcome|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525705|NCT00272168|O1|Outcome|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525745|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
525746|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525706|NCT00272168|E2|Reported Event|Arm 2: Control|"Supportive Treatment for SMI (control)~Supportive Treatment for SMI: Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members."
525707|NCT00272168|E1|Reported Event|Arm 1: MPROVE|"The Maryland Program for Vocational Effectiveness (MPROVE)~Maryland Program for Vocational Effectiveness: psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)"
525708|NCT00272038|B1|Baseline|Tarceva|Tarceva 150 mg QD
525709|NCT00272038|P1|Participant Flow|Tarceva|Tarceva 150 mg orally every day
525710|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
525711|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
525712|NCT00272038|O1|Outcome|Tarceva|Tarceva 150 mg QD
525713|NCT00272038|E1|Reported Event|Tarceva|Tarceva 150 mg QD
525714|NCT00271947|B1|Baseline|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
525715|NCT00271947|P1|Participant Flow|Autologous Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed after conditioning regimen
525716|NCT00271947|O1|Outcome|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
525717|NCT00271947|E1|Reported Event|Stem Cell Transplantation|stem cell transplantation : Autologous Hematopoietic Stem Cell Transplantation will be performed on all participants randomized to transplant arm.
525718|NCT00271856|B3|Baseline|Total|Total of all reporting groups
525719|NCT00271856|B2|Baseline|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525720|NCT00271856|B1|Baseline|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525721|NCT00271856|P2|Participant Flow|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525722|NCT00271856|P1|Participant Flow|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525723|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525724|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525725|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525726|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525727|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525728|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525729|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525730|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525731|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525732|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525733|NCT00271856|O2|Outcome|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525734|NCT00271856|O1|Outcome|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525735|NCT00271856|E2|Reported Event|1-HIV Education/Self-management|HIV education/self-management workshop: 8 weekly classes.
525736|NCT00271856|E1|Reported Event|0 Mindfulness-Based Stress Reduction (MBSR)|Mindfulness Based Stress Reduction (MBSR): 8 weekly evening meetings plus one all-day class.
525737|NCT00271817|B4|Baseline|Total|Total of all reporting groups
525738|NCT00271817|B3|Baseline|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
525739|NCT00271817|B2|Baseline|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
525740|NCT00271817|B1|Baseline|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg.
525741|NCT00271817|P3|Participant Flow|Ezetimibe/Simvastatin + Niacin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg as noted above) taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
525742|NCT00271817|P2|Participant Flow|Ezetimibe/Simvastatin|"(Part 1): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.~(Part 2): Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks."
525743|NCT00271817|P1|Participant Flow|Niacin|(Part 1): Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms started taking niacin 500 mg and had their niacin dose increased 500 mg every 4 weeks to 2000 mg. Patients in this treatment group were ramdomly reassigned for Part 2 of the study to one of two treatment groups- two-thirds of the patients enrolled in the niacin treatment group were randomly assigned to receive ezetimibe/simvastatin + niacin (ER) and the other one-third were randomly assigned to receive ezetimibe/simvastatin alone.
531616|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
525747|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
525748|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525749|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525750|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525751|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525752|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525753|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525754|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg + Niacin 2000 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525755|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks. Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 40 additional weeks for a total of 64 weeks.
525756|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525757|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
525758|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525759|NCT00271817|O1|Outcome|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin 10/20 mg taken orally once daily for 24 weeks.
525760|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525761|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
525762|NCT00271817|O2|Outcome|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin 10/20 mg + Niacin (titrated to 2000 mg) taken orally once daily for 24 weeks.
525763|NCT00271817|O1|Outcome|Niacin|Niacin titrated to 2000 mg taken orally once daily for 24 weeks. During the first 12 weeks of the study, patients randomized to the niacin containing arms had their niacin titrated (increased 500 mg every 4 weeks to 2000 mg).
525764|NCT00271817|E5|Reported Event|Ezetimibe/Simvastatin + Niacin - Part 2|Ezetimibe/Simvastatin + Niacin group from Part 2 All-Treated Patient as Treated Population
525765|NCT00271817|E4|Reported Event|Ezetimibe/Simvastatin - Part 2|EZ/Simva group from Part 2 All-Treated Patient as Treated Population
525766|NCT00271817|E3|Reported Event|Ezetimibe/Simvastatin + Niacin|Ezetimibe/Simvastatin + Niacin group from Part 1
525767|NCT00271817|E2|Reported Event|Ezetimibe/Simvastatin|Ezetimibe/Simvastatin group from Part 1
525768|NCT00271817|E1|Reported Event|Niacin|Niacin group from Part 1
525769|NCT00271739|B3|Baseline|Total|Total of all reporting groups
525770|NCT00271739|B2|Baseline|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525771|NCT00271739|B1|Baseline|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525772|NCT00271739|P2|Participant Flow|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525773|NCT00271739|P1|Participant Flow|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525774|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525775|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525776|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525777|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525778|NCT00271739|O2|Outcome|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525779|NCT00271739|O1|Outcome|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525780|NCT00271739|E2|Reported Event|Usual Care|Usual care consisted of continuing routine medical care, as prior to enrollment. Thus, diabetes management was performed by the participant’s Primary Care Provider.
525948|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525781|NCT00271739|E1|Reported Event|Telemedicine Case Management|Telemedicine case management was performed through regular video-calls between a nurse case manager and the participant, with upload of blood glucose and blood pressure data (taken by the participant) through the telemedicine unit.
525782|NCT00271609|B3|Baseline|Total|Total of all reporting groups
525783|NCT00271609|B2|Baseline|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
525784|NCT00271609|B1|Baseline|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
525785|NCT00271609|P2|Participant Flow|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
525786|NCT00271609|P1|Participant Flow|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
525787|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
525788|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
525789|NCT00271609|O2|Outcome|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
525790|NCT00271609|O1|Outcome|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
525791|NCT00271609|E2|Reported Event|Glioblastoma Multiforme (GBM)|Glioblastoma multiforme Gliosarcoma
525792|NCT00271609|E1|Reported Event|Anaplastic Glioma (AG)|Anaplastic astrocytoma Anaplastic oligodendroglioma Anaplastic mixed oligoastrocytoma Malignant astrocytoma (not otherwise specified)
525793|NCT00271596|B3|Baseline|Total|Total of all reporting groups
525794|NCT00271596|B2|Baseline|Placebo|Matching daily placebo
525795|NCT00271596|B1|Baseline|Citalopram|20mg daily citalopram
525796|NCT00271596|P2|Participant Flow|Placebo|Matching daily placebo
525797|NCT00271596|P1|Participant Flow|Citalopram|20mg daily citalopram
525798|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525799|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525800|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525801|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525802|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525803|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525804|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525805|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525806|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525807|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525808|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525809|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525810|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525811|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525812|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525813|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525814|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525815|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525816|NCT00271596|O2|Outcome|Placebo|Matching daily placebo
525817|NCT00271596|O1|Outcome|Citalopram|20mg daily citalopram
525818|NCT00271596|E2|Reported Event|Placebo|Matching daily placebo
525819|NCT00271596|E1|Reported Event|Citalopram|20mg daily citalopram
525820|NCT00271570|B3|Baseline|Total|Total of all reporting groups
525821|NCT00271570|B2|Baseline|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
525822|NCT00271570|B1|Baseline|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
525823|NCT00271570|P2|Participant Flow|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
525824|NCT00271570|P1|Participant Flow|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
525825|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
525826|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
525827|NCT00271570|O2|Outcome|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
525828|NCT00271570|O1|Outcome|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
525829|NCT00271570|E2|Reported Event|Infliximab (5mg/kg)|Remicade (Infliximab Arm of 5mg/kg)
525830|NCT00271570|E1|Reported Event|IVIG Arm (2 gr/kg)|2nd dose of IVIG (2gr/kg)
525831|NCT00271544|B1|Baseline|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
525832|NCT00271544|P1|Participant Flow|4196 Lead|Subjects underwent Model 4196 left ventricular lead implant attempt
525833|NCT00271544|O1|Outcome|4196 Lead|All enrolled subjects
525834|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode pacing impedance at 12-month
525835|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 12-month
525836|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode R-wave amplitude at implant
525837|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode pacing impedance at 12-month
525838|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold captured at 0.5ms at 12-month
525839|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode R-wave amplitude at 12-month
525840|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
525841|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
525842|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
525843|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
525844|NCT00271544|O1|Outcome|4196 Lead|Subjects successfully implanted with a Model 4196 lead
525845|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
525846|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt
525847|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent an implant attempt with successful CS cannulation
526058|NCT00270257|B3|Baseline|Total|Total of all reporting groups
525848|NCT00271544|O1|Outcome|4196 Lead|Subjects with ring electrode threshold captured at 0.5ms at 3-month
525849|NCT00271544|O1|Outcome|4196 Lead|Subjects with tip electrode threshold capture at 0.5ms at 1-month
525850|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 LV lead implant attempt
525851|NCT00271544|O1|Outcome|4196 Lead|Subjects who underwent Model 4196 left ventricular lead implant attempt
525852|NCT00271375|B4|Baseline|Total|Total of all reporting groups
525853|NCT00271375|B3|Baseline|Control Group Usual Care|Control: Control group usual care
525854|NCT00271375|B2|Baseline|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525855|NCT00271375|B1|Baseline|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525856|NCT00271375|P3|Participant Flow|Control Group Usual Care|Control: Control group usual care
525857|NCT00271375|P2|Participant Flow|Caring for You, Caring for me + Social Worker (Educational Int|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525858|NCT00271375|P1|Participant Flow|Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525859|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525860|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525861|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525862|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525863|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525864|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525865|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525866|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525867|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525868|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525869|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525870|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525871|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525872|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525873|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525874|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525875|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525876|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525877|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525878|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525879|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525880|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525881|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525882|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525883|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525884|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525885|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525886|NCT00271375|O3|Outcome|Arm 3: Control Group Usual Care|Control: Control group usual care
525887|NCT00271375|O2|Outcome|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525888|NCT00271375|O1|Outcome|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
531617|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
525889|NCT00271375|O1|Outcome|Overall Evaluation|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525890|NCT00271375|E3|Reported Event|Arm 3: Control Group Usual Care|Control: Control group usual care
525891|NCT00271375|E2|Reported Event|Arm 2: Caring for You, Caring for me + Social Worker (Educati|Caring for you, caring for me + social worker: 5-week Education and Support Program for Caregivers of older adults.+ augmentation with social worker
525892|NCT00271375|E1|Reported Event|Arm 1: Caring for You, Caring for me Educational Intervention|Caring For You, Caring For Me: 5-week Education and Support Program for Caregivers of older adults.
525893|NCT00271219|B3|Baseline|Total|Total of all reporting groups
525894|NCT00271219|B2|Baseline|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525895|NCT00271219|B1|Baseline|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525896|NCT00271219|P2|Participant Flow|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525897|NCT00271219|P1|Participant Flow|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525898|NCT00271219|O2|Outcome|Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525899|NCT00271219|O1|Outcome|Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525900|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525901|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525902|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525903|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525904|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525905|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525906|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525907|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525908|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525909|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525910|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525911|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525912|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525913|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525914|NCT00271219|O2|Outcome|B Buprenorphine|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525915|NCT00271219|O1|Outcome|A Methadone|"Methadone~Methadone : daily oral dosing 20-140 mg"
525916|NCT00271219|E4|Reported Event|Buprenorphine: Neonates|Neonates born to mothers maintained on buprenorphine
525917|NCT00271219|E3|Reported Event|Methadone: Neonates|Neonates born to mothers maintained on methadone
525918|NCT00271219|E2|Reported Event|Buprenorphine: Mothers|"Buprenorphine~Buprenorphine : sl daily 2-32 mg"
525919|NCT00271219|E1|Reported Event|Methadone: Mothers|"Methadone~Methadone : daily oral dosing 20-140 mg"
525920|NCT00271154|B3|Baseline|Total|Total of all reporting groups
525921|NCT00271154|B2|Baseline|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
525922|NCT00271154|B1|Baseline|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
525923|NCT00271154|P2|Participant Flow|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
525924|NCT00271154|P1|Participant Flow|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
525925|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
525926|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
525927|NCT00271154|O2|Outcome|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
525928|NCT00271154|O1|Outcome|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
525929|NCT00271154|E3|Reported Event|Not Randomized|These patients were enrolled in the study, but not randomized to CRT ON or CRT OFF. Their adverse events were collected until they exited the study.
525930|NCT00271154|E2|Reported Event|CRT ON|Cardiac Resynchronization Therapy (CRT) turned ON in conjunction with optimal medical therapy
525931|NCT00271154|E1|Reported Event|CRT OFF|Cardiac Resynchronization Therapy (CRT) turned OFF in conjunction with optimal medical therapy
525932|NCT00271024|B5|Baseline|Total|Total of all reporting groups
525933|NCT00271024|B4|Baseline|Placebo - FEMALE|Females receiving placebo as part of the trial
525934|NCT00271024|B3|Baseline|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525935|NCT00271024|B2|Baseline|Placebo - MALE|Males receiving placebo as part of the trial
525936|NCT00271024|B1|Baseline|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525937|NCT00271024|P4|Participant Flow|Placebo - FEMALE|Females receiving placebo as part of the trial
525938|NCT00271024|P3|Participant Flow|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525939|NCT00271024|P2|Participant Flow|Placebo - MALE|Males receiving placebo as part of the trial
525940|NCT00271024|P1|Participant Flow|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525941|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525942|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525943|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525944|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525945|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525946|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525947|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525949|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525950|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525951|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525952|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525953|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525954|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525955|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525956|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525957|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525958|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525959|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525960|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525961|NCT00271024|O2|Outcome|Naltrexone|Participants receiving Naltrexone as part of the trial
525962|NCT00271024|O1|Outcome|Placebo|Participants receiving Placebo as part of the trial
525963|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525964|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525965|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525966|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525967|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525968|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525969|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525970|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525971|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525972|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525973|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525974|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525975|NCT00271024|O4|Outcome|Placebo - FEMALE|Females receiving placebo as part of the trial
525976|NCT00271024|O3|Outcome|Naltrexone - FEMALE|Females receiving naltrexone as part of the trial
525977|NCT00271024|O2|Outcome|Placebo - MALE|Males receiving placebo as part of the trial
525978|NCT00271024|O1|Outcome|Naltrexone - MALE|Males receiving naltrexone as part of the trial
525979|NCT00271024|E2|Reported Event|Naltrexone|Participants receiving Naltrexone as part of the trial
525980|NCT00271024|E1|Reported Event|Placebo|Participants receiving Placebo as part of the trial
525981|NCT00271011|B1|Baseline|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
525982|NCT00271011|P1|Participant Flow|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
525983|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
525984|NCT00271011|O1|Outcome|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
525985|NCT00271011|E1|Reported Event|Mitomycin C, Irinotecan and Cetuximab|"Patients will receive mitomycin C 7 mg/m2 as a bolus infusion on day -1 of each 28 day cycle.~Patients will receive cetuximab 400 mg/m2 loading dose over 90 minutes cycle 1, day 1. All subsequent weekly cetuximab treatments will be 250 mg/m2 as a 60 minute infusion days 1, 8, 15, and 22 of each 28 day cycle.~Patients will receive irinotecan 140 mg/m2 as a 90 minute infusion on days 1 and 15 of each 28 day cycle after cetuximab infusion. Patients found to be homozygous for UGT1A1*28 allele will receive irinotecan 110 mg/m2."
525986|NCT00270894|B1|Baseline|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525987|NCT00270894|P1|Participant Flow|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
526084|NCT00270231|E2|Reported Event|Placebo Only|Placebo (sugar pill) recipients (taken for four days).
531618|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
525988|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525989|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525990|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525991|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525992|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525993|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525994|NCT00270894|O1|Outcome|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525995|NCT00270894|E1|Reported Event|Neoadjuvant Therapy|Neoadjuvant therapy will consist of epirubicin (100 mg/m^2) + cyclophosphamide (600 mg/m^2) every 2 weeks for 4 cycles; followed by a 3-week break; followed by docetaxel (75 mg/m^2) every 2 weeks for 4 cycles + trastuzumab (6 mg/kg [loading dose] once then 4 mg/kg [maintenance dose]) every 2 weeks for 4 treatments.
525996|NCT00270842|B4|Baseline|Total|Total of all reporting groups
525997|NCT00270842|B3|Baseline|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
525998|NCT00270842|B2|Baseline|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
525999|NCT00270842|B1|Baseline|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
526000|NCT00270842|P3|Participant Flow|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526001|NCT00270842|P2|Participant Flow|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526002|NCT00270842|P1|Participant Flow|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
526003|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526004|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526005|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
526006|NCT00270842|O3|Outcome|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526007|NCT00270842|O2|Outcome|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526008|NCT00270842|O1|Outcome|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
526009|NCT00270842|E3|Reported Event|Tai Chi|"Exercise Group that participated in tai chi training classes~Tai Chi: This intervention is a 10 week Tai Chi group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526010|NCT00270842|E2|Reported Event|Functional Balance Training|"Exercise group that participated in functional balance training~Functional Balance: This intervention is a 10 week Functional Balance group exercise class designed specifically for persons with Peripheral Neuropathy, having difficulty feeling their feet."
526011|NCT00270842|E1|Reported Event|Education Control Group|"Education group that is the control group for the study. Is a 10 week course with diverse health education topics.~Education Control group: This control group participated in 10 weeks of general health education classes."
526012|NCT00270790|B1|Baseline|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
526013|NCT00270790|P1|Participant Flow|AMIFOSTINE +2 Chemo Lines +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
526014|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
526015|NCT00270790|O1|Outcome|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
526016|NCT00270790|E1|Reported Event|AMIFOSTINE +CARBOPLATIN, TAXOL +RT|"EVALUATION OF AMIFOSTINE FOR MUCOSAL AND HEMOPOETIC PROTECTION AND CARBOPLATIN, TAXOL, RADIOTHERAPY IN THE MANAGEMENT OF PATIENTS WITH HEAD AND NECK CANCER.~Amifostine: Amifostine will be given at dose of 500 mg IV within one hour before radiation~Carboplatin: Carboplatin for 100 mg/m2~Taxol: Taxol will be given at a dose of 40 mg/m2 as a 3 hour infusion dose~Radiotherapy: Radiation will be given at a dose of 1.8 Gy. for a total of 70.2 Gy"
526017|NCT00270634|B5|Baseline|Total|Total of all reporting groups
526018|NCT00270634|B4|Baseline|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526019|NCT00270634|B3|Baseline|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526020|NCT00270634|B2|Baseline|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526021|NCT00270634|B1|Baseline|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526022|NCT00270634|P4|Participant Flow|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526023|NCT00270634|P3|Participant Flow|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526024|NCT00270634|P2|Participant Flow|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526025|NCT00270634|P1|Participant Flow|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526026|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526027|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526028|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526029|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526030|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526031|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526032|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526033|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526034|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526035|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526036|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526037|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526038|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526039|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526040|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526041|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526042|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526043|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526044|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526045|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526046|NCT00270634|O4|Outcome|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526047|NCT00270634|O3|Outcome|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526048|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526049|NCT00270634|O1|Outcome|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526050|NCT00270634|O4|Outcome|Tacrolimus|Standard dose
526051|NCT00270634|O3|Outcome|Low Dose Voclosporin|Starting dose of 0.4 mg/kg
526052|NCT00270634|O2|Outcome|Mid Dose Voclosporin|Starting dose of 0.6 mg/kg
526053|NCT00270634|O1|Outcome|High Dose Voclosporin|Starting dose of 0.8 mg/kg
526054|NCT00270634|E4|Reported Event|Tacrolimus|Standard Dose Tacrolimus: Initial dose of 0.05 mg/kg po BID
526055|NCT00270634|E3|Reported Event|Low Dose Voclosporin|Low dose voclosporin: Initial dose of 0.4 mg/kg po BID
526056|NCT00270634|E2|Reported Event|Mid Dose Voclosporin|Mid Dose Voclosporin: Initial dose of 0.6 mg/kg po BID
526057|NCT00270634|E1|Reported Event|High Dose Voclosporin|High Dose Voclosporin: Initial dose of 0.8 mg/kg po BID
526059|NCT00270257|B2|Baseline|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526060|NCT00270257|B1|Baseline|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526061|NCT00270257|P2|Participant Flow|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526062|NCT00270257|P1|Participant Flow|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526063|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
526064|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
526065|NCT00270257|O2|Outcome|Thailand|Long Term and Short arms were compared
526066|NCT00270257|O1|Outcome|China|Long Term and Short arms were compared
526067|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526068|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526069|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526070|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526071|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526072|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526073|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526074|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526075|NCT00270257|O2|Outcome|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526076|NCT00270257|O1|Outcome|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526077|NCT00270257|E2|Reported Event|Short Term Medication Assisted Treatment (ST-MAT)|"Participants will receive short-term BUP/NX; dosage and length of treatment will be determined by the investigator.Additionally, participants will undergo weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52.~Buprenorphine/Naloxone: Oral tablet"
526078|NCT00270257|E1|Reported Event|Long Term Medication Assisted Treatment (LT-MAT)|"Participants will receive BUP/NX under the tongue daily for a maximum of three weeks(until dose stabilization) and then three times a week for 52 weeks in addition to weekly drug and risk reduction counseling for 12 weeks, and then every 4 weeks through Week 52~Buprenorphine/Naloxone: Oral tablet"
526079|NCT00270231|B1|Baseline|Entire Study Population|Includes subjects with both OPRM1 genotypes (Asp40 (A/G or G/G allele vs. Asn40 (A/A) allele) who started Intervention Period 1.
526080|NCT00270231|P2|Participant Flow|Placebo, Then Naltrexone|"These participants took placebo (sugar pill) during their first 4-day study period.~They received active naltrexone during the second 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg."
526081|NCT00270231|P1|Participant Flow|Naltrexone, Then Placebo|"These participants took active naltrexone during their first 4-day study period. The dosing for naltrexone was the same for all participants. Day 1 = 12.5mg, Day 2 = 25mg, Days 3 & 4 = 50mg.~They received placebo (sugar pill) during the second 4-day study period."
526082|NCT00270231|O2|Outcome|OPRM1 Genotype - A/G or G/G|Participants who have the Asp40 OPRM1=A/G or G/G
526083|NCT00270231|O1|Outcome|OPRM1 Genotype - A/A|Participants who have the Asn40 OPRM1=A/A
526085|NCT00270231|E1|Reported Event|Naltrexone Only|Active medication recipients (Naltrexone taken for 4 days).
526086|NCT00270205|B5|Baseline|Total|Total of all reporting groups
526087|NCT00270205|B4|Baseline|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526088|NCT00270205|B3|Baseline|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526089|NCT00270205|B2|Baseline|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526090|NCT00270205|B1|Baseline|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526091|NCT00270205|P4|Participant Flow|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526092|NCT00270205|P3|Participant Flow|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526093|NCT00270205|P2|Participant Flow|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526094|NCT00270205|P1|Participant Flow|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526095|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526096|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526097|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526098|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526099|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526100|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526101|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526102|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526103|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526104|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526105|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526106|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526107|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526108|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526109|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526110|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526111|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526112|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526113|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526114|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526115|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526116|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526117|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526118|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526119|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526120|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526121|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526122|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526123|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526124|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526125|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526126|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526127|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526128|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526129|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526130|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526131|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526132|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526179|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
531619|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
526133|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526134|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526135|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526136|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526137|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526138|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526139|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526140|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526141|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526142|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526143|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526144|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526145|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526146|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526147|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526148|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526149|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526150|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526151|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526152|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526153|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526154|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526155|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526203|NCT00269919|B1|Baseline|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
531620|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
526156|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526157|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526158|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526159|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526160|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526161|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526162|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526163|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526164|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526165|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526166|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526167|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526168|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526169|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526170|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526171|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526172|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526173|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526174|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526175|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526176|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526177|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526178|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526540|NCT00267631|E2|Reported Event|Normal Body Weight|Children with a BMI of 25 to 75%
526180|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526181|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526182|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526183|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526184|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526185|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526186|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526187|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526188|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526189|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526190|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526191|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526192|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526193|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526194|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526195|NCT00270205|O4|Outcome|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526196|NCT00270205|O3|Outcome|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526197|NCT00270205|O2|Outcome|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526198|NCT00270205|O1|Outcome|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526199|NCT00270205|E4|Reported Event|Placebo|All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
526200|NCT00270205|E3|Reported Event|E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13|Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
526201|NCT00270205|E2|Reported Event|C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites [on the left and right upper back and left and right upper ventral thigh] of 80 cm^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
526202|NCT00270205|E1|Reported Event|A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13|Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites [on the left and right upper back] of 80 cm^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
526541|NCT00267631|E1|Reported Event|At Risk Body Weight|Children with a BMI greater and equal to 85%
526204|NCT00269919|P1|Participant Flow|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly (into a muscle) depending on Investigator’s discretion every 2 weeks for 2 years.
526205|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526206|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526207|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg had been administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526208|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526209|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526210|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526211|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526212|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526213|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526214|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526215|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526216|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526217|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526218|NCT00269919|O1|Outcome|Risperidone Long-Acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526219|NCT00269919|E1|Reported Event|Risperidone Long-acting Injection (RLAI)|The RLAI 25 milligram (mg) or 37.5 mg or 50 mg was administered intramuscularly depending on Investigator’s discretion every 2 weeks for 2 years.
526220|NCT00269633|B3|Baseline|Total|Total of all reporting groups
526221|NCT00269633|B2|Baseline|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
526222|NCT00269633|B1|Baseline|Red Light Box|"657 nm~Red Light Box: 657 nm Red LED Light"
526223|NCT00269633|P2|Participant Flow|Blue Light Box 467 nm|LED Blue Light Box 467 nm
526224|NCT00269633|P1|Participant Flow|Red Light Box 657 nm|LED Red Light Box 657 nm
526225|NCT00269633|O2|Outcome|Blue Light Box 467 nm|LED Blue Light Box 467 nm
526226|NCT00269633|O1|Outcome|Red Light Box 657 nm|LED Red Light Box 657 nm
526227|NCT00269633|E2|Reported Event|Blue Light Box|"467 nm~Blue Light Box: 467 nm Blue LED Light"
526228|NCT00269633|E1|Reported Event|Red Light Box|Red Light Box: 657 nm Blue LED Light
526229|NCT00269477|B5|Baseline|Total|Total of all reporting groups
526230|NCT00269477|B4|Baseline|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526231|NCT00269477|B3|Baseline|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
526232|NCT00269477|B2|Baseline|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526233|NCT00269477|B1|Baseline|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
526234|NCT00269477|P4|Participant Flow|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526235|NCT00269477|P3|Participant Flow|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
526236|NCT00269477|P2|Participant Flow|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526263|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
531621|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
526237|NCT00269477|P1|Participant Flow|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
526238|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526239|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
526240|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526241|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
526242|NCT00269477|O4|Outcome|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526243|NCT00269477|O3|Outcome|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
526244|NCT00269477|O2|Outcome|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526245|NCT00269477|O1|Outcome|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
526246|NCT00269477|E4|Reported Event|Meningococcal Vaccine-naive Group 4|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526247|NCT00269477|E3|Reported Event|Meningococcal Vaccine-naive Group 3|Participants have never received Meningococcal vaccine and provided one blood sample pre-vaccination on Day 0, received a dose of Menactra vaccine on Day 0, and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination
526248|NCT00269477|E2|Reported Event|Menactra® Vaccine Group 2|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 5, Day 14, and Day 28 post-vaccination.
526249|NCT00269477|E1|Reported Event|Menactra® Vaccine Group 1|Participants had previously received a dose of Menactra® vaccine in Study MTA02,did not participate in Study MTA19 (NCT 00777790). They provided a pre-vaccination blood sample on Day 0, received one booster dose of Menactra vaccine on Day 0 and provided 3 additional blood samples on Day 3, Day 7, and Day 28 post-vaccination.
526250|NCT00269152|B3|Baseline|Total|Total of all reporting groups
526251|NCT00269152|B2|Baseline|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526252|NCT00269152|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526253|NCT00269152|P2|Participant Flow|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 milligrams per milliliter*minute (mg/ml*min), intravenous (IV), every 21 days x 4 cycles
526254|NCT00269152|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526255|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526256|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526257|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526258|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526259|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526260|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526261|NCT00269152|O2|Outcome|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526262|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526612|NCT00267111|P1|Participant Flow|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
526264|NCT00269152|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526265|NCT00269152|E2|Reported Event|Pemetrexed + Carboplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Carboplatin: area under the curve (AUC) 5 mg/ml*min, intravenous (IV), every 21 days x 4 cycles
526266|NCT00269152|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days x 4 cycles Cisplatin: 75 mg/m^2, intravenous (IV), every 21 days x 4 cycles
526267|NCT00269113|B3|Baseline|Total|Total of all reporting groups
526268|NCT00269113|B2|Baseline|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526269|NCT00269113|B1|Baseline|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526270|NCT00269113|P2|Participant Flow|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526271|NCT00269113|P1|Participant Flow|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 milligrams per square meter (mg/m^2), intravenously (IV), on Days 1 and 2, chlorambucil 3 times (x) 3 mg/m^2, by mouth (PO), every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a complete remission (CR) or partial remission (PR) following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with interferon (IFN) alpha 3 x 4.5 million international units (IU) per week, subcutaneously (SC), until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526272|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526273|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526274|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526299|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526300|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526275|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526276|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526277|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526278|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526279|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526280|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526281|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526282|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526301|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526302|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526283|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526284|NCT00269113|O2|Outcome|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526285|NCT00269113|O1|Outcome|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526286|NCT00269113|E2|Reported Event|Rituximab + MCP|Participants received rituximab 375 mg/m^2, IV on Day 1, mitoxantrone 8 mg/m^2, IV, on Days 3 and 4, chlorambucil 3 x 3 mg/m^2, PO every 8 hours on Days 3 through 7, and prednisolone 25 mg/m^2, PO on Days 3 through 7. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526287|NCT00269113|E1|Reported Event|Mitoxantrone, Chlorambucil, Prednisolone (MCP)|Participants received mitoxantrone 8 mg/m^2, IV, on Days 1 and 2, chlorambucil 3 x 3 mg/m^2, PO, every 8 hours on Days 1 through 5, and prednisolone at 25 mg/m^2, PO on Days 1 through 5. This cycle was repeated at 4-week intervals for a minimum of 6 cycles and a maximum of 8 cycles. After Cycles 2 and 6, participants were assessed for response; participants with no change or with progressive disease (or with minimal response at Cycle 6) were withdrawn from therapy. Participants achieving a CR or PR following induction therapy with MCP were administered maintenance therapy (per standard of care and at the discretion of the investigator) with IFN alpha 3 x 4.5 mIU per week, SC, until progression or withdrawal. Participants could have also received 3 x 500 mg of paracetamol/day during the first weeks of IFN therapy.
526288|NCT00268983|B3|Baseline|Total|Total of all reporting groups
526289|NCT00268983|B2|Baseline|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526290|NCT00268983|B1|Baseline|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526291|NCT00268983|P2|Participant Flow|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526292|NCT00268983|P1|Participant Flow|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526293|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526294|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526295|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526296|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526297|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526298|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
531622|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
526303|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526304|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526305|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526306|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526307|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526308|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526309|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526310|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526311|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526312|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526313|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526314|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526315|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526316|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526317|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526318|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526319|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526320|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526321|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526322|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526323|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526324|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526325|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526326|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526431|NCT00267969|O1|Outcome|Group 1: Ustekinumab 45 mg Withdrawal Group|Patients received ustekinumab 45 mg at Weeks 0, 4, 16 and 28.
526613|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
531623|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
526327|NCT00268983|O2|Outcome|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526328|NCT00268983|O1|Outcome|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526329|NCT00268983|E2|Reported Event|TST/I-131 TST|"Dosimetric dose, Given once on Day 1: Tositumomab (TST) infused over 1 hour, followed by 5 millicuries (mCi) I 131 Tositumomab (I-131 TST) infused over 20 minutes;~Therapeutic dose, Given only once between Day 7 and Day 14:~450 mg TST infused over 1 hour, followed by individualized mCi activity of I-131 TST (35 mg) infused over 20 minutes"
526330|NCT00268983|E1|Reported Event|Rituximab 375 mg/m^2|Rituximab 375 milligrams per meters squared (mg/m^2) given as an intravenous infusion once weekly for four weeks (Day 0, Day 7, Day 14, and Day 21)
526331|NCT00268905|B4|Baseline|Total|Total of all reporting groups
526332|NCT00268905|B3|Baseline|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526333|NCT00268905|B2|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526334|NCT00268905|B1|Baseline|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526335|NCT00268905|P3|Participant Flow|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526336|NCT00268905|P2|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526337|NCT00268905|P1|Participant Flow|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526338|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526339|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526340|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526341|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526342|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526343|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526344|NCT00268905|O3|Outcome|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526345|NCT00268905|O2|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526346|NCT00268905|O1|Outcome|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526347|NCT00268905|E3|Reported Event|Eribulin Mesylate 1.1 mg/m^2 Plus Carboplatin AUC 6|Eribulin mesylate 1.1 mg/m2 plus carboplatin AUC 6 in subjects with non small cell lung cancer (NSCLC)
526348|NCT00268905|E2|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 6|Eribulin mesylate dose finding plus carboplatin AUC 6 in subjects with advanced solid tumors
526349|NCT00268905|E1|Reported Event|Eribulin Mesylate Dose Finding Plus Carboplatin AUC 5|Eribulin mesylate dose finding plus carboplatin AUC 5 in subjects with advanced solid tumors
526350|NCT00268892|B4|Baseline|Total|Total of all reporting groups
526351|NCT00268892|B3|Baseline|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526352|NCT00268892|B2|Baseline|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526353|NCT00268892|B1|Baseline|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526354|NCT00268892|P3|Participant Flow|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526355|NCT00268892|P2|Participant Flow|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526356|NCT00268892|P1|Participant Flow|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526357|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526358|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526359|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526360|NCT00268892|O3|Outcome|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526361|NCT00268892|O2|Outcome|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526362|NCT00268892|O1|Outcome|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526363|NCT00268892|E3|Reported Event|Degarelix 240/240@60(1-4-7-10)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526364|NCT00268892|E2|Reported Event|Degarelix 240/240@60(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526365|NCT00268892|E1|Reported Event|Degarelix 240/240@40(1-3-6-9)|Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
526366|NCT00268762|B1|Baseline|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
526367|NCT00268762|P1|Participant Flow|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target partial thromboplastin time (PTT) of 1.75 times the patient's baseline.
526368|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
526369|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
526370|NCT00268762|O1|Outcome|Intervention|Argatroban IV Infusion 1 mcg/kg/min for 48 hours
526371|NCT00268762|E1|Reported Event|Intervention|Argatroban IV bolus 100 mcg/kg bolus, followed by Argatroban IV Infusion 1 mcg/kg/min for 48 hours. Dose adjusted for target PTT of 1.75 times the patient's baseline.
526372|NCT00268463|B3|Baseline|Total|Total of all reporting groups
526373|NCT00268463|B2|Baseline|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
526374|NCT00268463|B1|Baseline|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
526375|NCT00268463|P2|Participant Flow|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
526376|NCT00268463|P1|Participant Flow|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
526377|NCT00268463|O2|Outcome|Arm 2: Floxuridine + Oxaliplatin + Capecitabine|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 22 every 42 days for 4 cycles and then on day 1 every 21 days for 4 cycles~Oral capecitabine 850 mg/m2 twice daily on days 22-35 every 42 days for 4 cycles and then on days 1-14 every 21 days for 4 cycles~Continuous hepatic arterial infusion of floxuridine 0.2 mg/kg on days 1-14 every 42 days for 4 cycles"
526378|NCT00268463|O1|Outcome|Arm 1: Capecitabine + Oxaliplatin|"Oxaliplatin 130 mg/m2 IV over 2 hours on day 1 every 21 days for 8 cycles: Arm 1~Oral capecitabine 850 mg/m2 twice daily on days 1-14 every 21 days for 8 cycles: Arm 1"
526379|NCT00268463|E2|Reported Event|Floxuridine + Oxaliplatin + Capecitabine|Floxuridine + Oxaliplatin + Capecitabine
526380|NCT00268463|E1|Reported Event|Capecitabine + Oxaliplatin|Capecitabine + Oxaliplatin
526381|NCT00268437|B1|Baseline|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation >~> carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment. >~> conventional surgery >~> neoadjuvant therapy >~> radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field)."
526382|NCT00268437|P1|Participant Flow|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
526383|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
526384|NCT00268437|O1|Outcome|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~conventional surgery"
526385|NCT00268437|E1|Reported Event|Pemetrexed/Carboplatin|"Pemetrexed+Carboplatin+Radiation carboplatin: carboplatin is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Pemetrexed: Pemetrexed is to be given on days 1 and 22 of the 5 ½ weeks of radiation treatment.~Radiation therapy: Radiation therapy begins day 1 and continues for 5 ½ weeks (45 Gy in 22-25 fractions of 1.8 Gy to extended field; 50.4 Gy in 28 fractions within boost field).~Conventional surgery"
526386|NCT00268346|B3|Baseline|Total|Total of all reporting groups
526387|NCT00268346|B2|Baseline|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526388|NCT00268346|B1|Baseline|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526389|NCT00268346|P2|Participant Flow|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526390|NCT00268346|P1|Participant Flow|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526391|NCT00268346|O2|Outcome|Prior Chemotherapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
526392|NCT00268346|O1|Outcome|No Prior Therapy|All patients will receive oral ZD1839 250 mg daily. Pill counts will be conducted at every visit to monitor compliance. Treatment will be continued for a minimum of 8 weeks.
526393|NCT00268346|E2|Reported Event|Prior Chemotherapy|Patients may not have received more than one previous systemic treatment regimen. Systemic treatment may have been given as part of definitive (adjuvant, neoadjuvant, concurrent, or sequential) management or for metastatic or recurrent disease. Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526394|NCT00268346|E1|Reported Event|No Prior Chem Therapy|Patients receive oral gefitinib once daily for at least 8 weeks in the absence of disease progression or unacceptable toxicity.
526395|NCT00268242|B1|Baseline|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526396|NCT00268242|P1|Participant Flow|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526397|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526398|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526399|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526400|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526401|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526402|NCT00268242|O1|Outcome|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526403|NCT00268242|E1|Reported Event|Gemcitabine + Mitoxantrone|"Gemcitabine Hydrochloride as administered as a continuous intravenous infusion (I.V.) at 10mg/m^2/minute for 12 hours, starting on Day 1. Mitoxantrone Hydrochloride was given at a dose of 12mg/m^2/day I.V. on days 1, 2, and 3.~Gemcitabine Hydrochloride: 10 mg/m2/ min IV for 12 hours~Mitoxantrone Hydrochloride: 12 mg/m2/day IV (administer over 30-60 minutes) on Day 1, 2 and 3"
526494|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526404|NCT00268203|B1|Baseline|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526405|NCT00268203|P1|Participant Flow|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526406|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526407|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526408|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526409|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526410|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526432|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
526495|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526614|NCT00267111|O1|Outcome|Amethocaine Gel 4% Group|1 g Amethocaine gel 4% was used as the active drug
526411|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526412|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526413|NCT00268203|O1|Outcome|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526414|NCT00268203|E1|Reported Event|Tositumomab and Iodine I-131 Tositumomab|Participants were treated with a saturated solution of potassium iodide (KI), Lugol’s solution, or KI tablets starting at least 24 hours prior to the first infusion of Iodine I-131 Tositumomab (TST) and continuing for 14 days following the last infusion of Iodine I-131 TST. Participants received treatment in two phases. The dosimetric dose was administered in Phase 1 as 450 milligrams (mg) of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by 5 millicurie (mCi) of Iodine I-131 TST infused over 20 minutes (min), followed by a 10-min normal saline flush. The therapeutic dose, administered 7–14 days after the dosimetric dose, was administered as 450 mg of TST infused over 1 hour (preceded by the administration of oral acetaminophen and an antihistamine), followed by the appropriate activity (mCi) of Iodine I-131 TST infused over 20 min, followed by a 10-min normal saline flush.
526415|NCT00267969|B4|Baseline|Total|Total of all reporting groups
526416|NCT00267969|B3|Baseline|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
526417|NCT00267969|B2|Baseline|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
526418|NCT00267969|B1|Baseline|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
526419|NCT00267969|P7|Participant Flow|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
526420|NCT00267969|P6|Participant Flow|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
526421|NCT00267969|P5|Participant Flow|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
526422|NCT00267969|P4|Participant Flow|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
526423|NCT00267969|P3|Participant Flow|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
526424|NCT00267969|P2|Participant Flow|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
526425|NCT00267969|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
526426|NCT00267969|O6|Outcome|Group 6: Combined Ustekinumab Every 12 Weeks|Groups 2 and 4 (Combined Ustekinumab every 12 weeks)
526427|NCT00267969|O5|Outcome|Group 5: Withdrawal Combined Group|Groups 1 and 3 (Withdrawal Combined)
526428|NCT00267969|O4|Outcome|Group 4: Ustekinumab 90 mg Every 12 Weeks|Patients received ustekinumab 90 mg at Weeks 0, 4, 16, 28 and 40.
526429|NCT00267969|O3|Outcome|Group 3: Ustekinumab 90 mg Withdrawal|Patients received ustekinumab 90 mg at Weeks 0, 4, 16 and 28.
526430|NCT00267969|O2|Outcome|Group 2: Ustekinumab 45 mg Every 12 Weeks|Patients received ustekinumab 45 mg at Weeks 0, 4, 16, 28 and 40.
526797|NCT00266864|B3|Baseline|Total|Total of all reporting groups
526433|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
526434|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
526435|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
526436|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
526437|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
526438|NCT00267969|O3|Outcome|Ustekinumab 90 mg|Patients received ustekinumab 90 mg at Week 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 90 mg every 12 week maintenance therapy.
526439|NCT00267969|O2|Outcome|Ustekinumab 45 mg|Patients received ustekinumab 45 mg at Weeks 0, 4 and 16. Treatments after Week 16 were dependent on clinical response. At Week 40, patients who achieved PASI 75 at both Week 28 and Week 40 were re-randomized to withdraw from therapy (placebo) or continue 45 mg every 12 week maintenance therapy.
526440|NCT00267969|O1|Outcome|Placebo|Patients received placebo at Weeks 0 and 4. At Weeks 12 and 16, placebo crossed over to receive ustekinumab 45 mg or 90 mg. Treatments after Week 16 were dependent on clinical response.
526441|NCT00267969|E7|Reported Event|Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 90 mg at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
526442|NCT00267969|E6|Reported Event|Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving ustekinumab 45 mg at Weeks 0 and 4 -> receiving ustekinumab 45 mg q12wk or q8wk from Week 16 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
526443|NCT00267969|E5|Reported Event|Placebo -> Ustekinumab 90 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 90 mg q12wk or q8wk from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 90 q12w.
526444|NCT00267969|E4|Reported Event|Placebo -> Ustekinumab 45 mg (After CP)|After Controlled period (Week 12-264) – patients receiving Placebo at Weeks 0 and 4 -> receiving ustekinumab 45 mg every 12 weeks (q12wk) or every 8 weeks (q8wk) from Week 12 to Week 244. Some patients were withdrawn from ustekinumab at Week 40 and re-treated with ustekinumab 45 q12w.
526445|NCT00267969|E3|Reported Event|Ustekinumab 90 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 90 mg group
526446|NCT00267969|E2|Reported Event|Ustekinumab 45 mg (CP)|Controlled period (Week 0-12) - Ustekinumab 45 mg group
526447|NCT00267969|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo group
526448|NCT00267956|B3|Baseline|Total|Total of all reporting groups
526449|NCT00267956|B2|Baseline|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526450|NCT00267956|B1|Baseline|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526451|NCT00267956|P4|Participant Flow|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
526452|NCT00267956|P3|Participant Flow|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
526453|NCT00267956|P2|Participant Flow|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab x 4 Group
526454|NCT00267956|P1|Participant Flow|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
526455|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526456|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526457|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526458|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526492|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526459|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526460|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526461|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526462|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526463|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526464|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526465|NCT00267956|O2|Outcome|Group II: Ustekinumab x 4|Participants received SC injection of ustekinumab 90 mg at Wk 0,1,2, and 3. At Wk 12 and Wk 16, participants received placebo SC to maintain the blind. After the first 36 participants were randomized, Centocor became aware that some vials of other study agents not used in this study contained black particulate matter and the filtration procedure was implemented. The resulting dose of ustekinumab after filtration was approximately 0.70 mL, equivalent to 63 mg.
526466|NCT00267956|O1|Outcome|Group I: Placebo|Participants received subcutaneous (SC) placebo injection at Weeks 0, 1,2, and 3. At Week (Wk) 12 and Wk 16, placebo participants crossed over to receive ustekinumab (CNTO 1275) SC.
526467|NCT00267956|E4|Reported Event|Ustekinumab x 4 (After CP)|After Controlled period (Week 12-36) - receiving ustekinumab at Weeks 0, 1, 2, and 3 -> receiving Placebo at Week 12 and Week 16
526468|NCT00267956|E3|Reported Event|Placebo -> Ustekinumab (After CP)|After Controlled period (Week 12-36) - receiving Placebo at Weeks 0, 1, 2, and 3 -> receiving ustekinumab at Week 12 and Week 16
526469|NCT00267956|E2|Reported Event|Ustekinumab x 4 (CP)|Controlled period (Week 0-12) - Ustekinumab (CNTO 1275) x 4 Group
526470|NCT00267956|E1|Reported Event|Placebo (CP)|Controlled period (Week 0-12) - Placebo Group
526471|NCT00267774|B3|Baseline|Total|Total of all reporting groups
526472|NCT00267774|B2|Baseline|Angio-guided PCI|Angio-guided PCI
526473|NCT00267774|B1|Baseline|FFR Guided PCI|Fractional flow reserve
526474|NCT00267774|P2|Participant Flow|Angio-guided PCI|Angio-guided PCI
526475|NCT00267774|P1|Participant Flow|FFR Guided PCI|Fractional flow reserve
526476|NCT00267774|O2|Outcome|Angio-guided PCI|Angio-guided PCI
526477|NCT00267774|O1|Outcome|FFR Guided PCI|Fractional flow reserve
526478|NCT00267774|E2|Reported Event|Angio-guided PCI|Angio-guided PCI
526479|NCT00267774|E1|Reported Event|FFR Guided PCI|Fractional flow reserve
526480|NCT00267748|B4|Baseline|Total|Total of all reporting groups
526481|NCT00267748|B3|Baseline|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526482|NCT00267748|B2|Baseline|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526483|NCT00267748|B1|Baseline|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
526484|NCT00267748|P3|Participant Flow|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526485|NCT00267748|P2|Participant Flow|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526486|NCT00267748|P1|Participant Flow|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
526487|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526488|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526489|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526490|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526491|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526493|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526496|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526497|NCT00267748|O2|Outcome|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526498|NCT00267748|O1|Outcome|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526499|NCT00267748|E3|Reported Event|Sunitinib 37.5 mg|Sunitinib 37.5 mg continuous daily dosing (CDD) self administered orally once daily in the morning.
526500|NCT00267748|E2|Reported Event|Sunitinib 50 mg (Schedule 4/2)|Sunitinib 50 mg self administered orally, once daily in the morning for 4 consecutive weeks followed by 2 weeks off treatment to comprise a complete 6-weeks cycle.
526501|NCT00267748|E1|Reported Event|Sunitinib 37.5 mg + Interferon Alpha-2b|Sunitinib 37.5 mg or 50 mg self administered orally once daily in the evening for 4 consecutive weeks followed by 2 weeks off (Schedule 4/2) to comprise a complete 6-weeks cycle. Concomitant Interferon (IFN) alpha-2b self-administered at a dose of 3 million units (MU) or 6 MU or 9MU subcutaneously (s.c.) 3 times weekly on non-consecutive days for up to 1 year (9 cycles) of treatment or early withdrawal.
526502|NCT00267696|B1|Baseline|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administred on day 1 and day 15 of a 28 day cycle~Carboplatin"
526503|NCT00267696|P1|Participant Flow|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
526504|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
526505|NCT00267696|O1|Outcome|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
526506|NCT00267696|E1|Reported Event|Gemcitabine/Carboplatin/Bevacizumab|"A regimen consisting of gemcitabine(1000 mg/m2)/carboplatin(AUC 3) / bevacizumab(Avastin®)(10mg/kg) will be administered on day 1 and day 15 of a 28 day cycle.~Bevacizumab: Bevacizumab(Avastin)=10mg/kg on day 1, day 15 of a 28 day cycle.~Gemcitabine: A regimen consisting of gemcitabine 1000 mg/m2 will be administered on day 1 and day 15 of a 28 day cycle~Carboplatin"
526507|NCT00267670|B3|Baseline|Total|Total of all reporting groups
526508|NCT00267670|B2|Baseline|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
526509|NCT00267670|B1|Baseline|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526510|NCT00267670|P2|Participant Flow|Placebo|This group was given a capsule identical to pentoxifylline that contained sucrose.
526511|NCT00267670|P1|Participant Flow|Pentoxifylline|This group was given pentoxifylline 400mg thrice daily (tid) for 1 year
526512|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
526513|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526514|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
526515|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526516|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
526517|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526518|NCT00267670|O2|Outcome|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose.
526519|NCT00267670|O1|Outcome|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526520|NCT00267670|E2|Reported Event|Placebo|Patients in this group received a capsule identical to pentoxifylline that instead contained sucrose thrice daily for 1 year.
526521|NCT00267670|E1|Reported Event|Pentoxifylline|Patients in this group received pentoxifylline 400mg tid for 1 year.
526522|NCT00267644|B3|Baseline|Total|Total of all reporting groups
526523|NCT00267644|B2|Baseline|Controls|
526524|NCT00267644|B1|Baseline|Cases|
526525|NCT00267644|P2|Participant Flow|Controls|Hydrated Pediatric Patients
526526|NCT00267644|P1|Participant Flow|Cases|Dehydrated Pediatric Patients
526527|NCT00267644|O2|Outcome|Controls|Hydrated Pediatric Patients
526528|NCT00267644|O1|Outcome|Cases|Dehydrated Pediatric Patients
526529|NCT00267644|O2|Outcome|Controls|Pediatric Patients that were hydrated
526530|NCT00267644|O1|Outcome|Cases|Pediatric Patients who were dehydrated
526531|NCT00267644|E2|Reported Event|Controls|
526532|NCT00267644|E1|Reported Event|Cases|
526533|NCT00267631|B3|Baseline|Total|Total of all reporting groups
526534|NCT00267631|B2|Baseline|Normal Body Weight|Children with a BMI of 25 to 75%
526535|NCT00267631|B1|Baseline|At Risk Body Weight|Children with BMI greater adn equal to 85%
526536|NCT00267631|P2|Participant Flow|NOrmal Body Weight|Children with BMI of 25-75%
526537|NCT00267631|P1|Participant Flow|At Risk Body Weight|Children with BMI greater and equal to 85%
526538|NCT00267631|O2|Outcome|Normal Body Weight|Children with BMI of 25-75%
526539|NCT00267631|O1|Outcome|At Risk Body Weight|Children with BMI greater and equal to 85%
526542|NCT00267488|B1|Baseline|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526543|NCT00267488|P1|Participant Flow|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526544|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526545|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526546|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526547|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526548|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526549|NCT00267488|O1|Outcome|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526550|NCT00267488|E1|Reported Event|Topotecan Hydrochloride|Subjects received IV weekly Topotecan administered at either 2.5 mg/m2(if the subject had prior pelvic radiotherapy) or 3.0 mg/m2 on Days 1, 8 and 15(+ or - 2 days) every 28 days.
526551|NCT00264875|B1|Baseline|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
526552|NCT00264875|P1|Participant Flow|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
526553|NCT00264875|O1|Outcome|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
526554|NCT00264875|E1|Reported Event|Pregabalin|Subjects who met all eligibility criteria initiated open-label treatment at 150 mg/day (75 mg BID). Further adjustments of total daily dose within the dose range 150 to 600 mg/day (BID) were permitted throughout the study to optimize pain control and minimize adverse events (AEs).
526555|NCT00267293|B4|Baseline|Total|Total of all reporting groups
526556|NCT00267293|B3|Baseline|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
526557|NCT00267293|B2|Baseline|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
526558|NCT00267293|B1|Baseline|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
526559|NCT00267293|P3|Participant Flow|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
526560|NCT00267293|P2|Participant Flow|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
526561|NCT00267293|P1|Participant Flow|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
526562|NCT00267293|O3|Outcome|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
526563|NCT00267293|O2|Outcome|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
526564|NCT00267293|O1|Outcome|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
526565|NCT00267293|E3|Reported Event|Group C: Ibuprofen Then Acetaminophen|Time 0 child is given Ibuprofen (10mg/kg) and at time 3 hours is given (15 mg/kg. Temperature in °C measured hourly for 6 hours.
526566|NCT00267293|E2|Reported Event|Group B: Ibuprofen and Acetaminophen|time 0 child Ibuprofen (10mg/kg) and Acetaminophen (15 mg/kg)given. Temperature in °C measured hourly for 6 hours.
526567|NCT00267293|E1|Reported Event|Group A: Ibuprofen Alone|Time 0 Ibuprofen (10mg/kg)given. Temperature in °C measured hourly for 6 hours.
526568|NCT00267202|B3|Baseline|Total|Total of all reporting groups
526569|NCT00267202|B2|Baseline|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526570|NCT00267202|B1|Baseline|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526571|NCT00267202|P2|Participant Flow|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526572|NCT00267202|P1|Participant Flow|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526573|NCT00267202|O3|Outcome|All Patients|
526574|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526575|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526576|NCT00267202|O3|Outcome|All Patients|
526577|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526578|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526579|NCT00267202|O3|Outcome|All Patients|
526580|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526581|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526582|NCT00267202|O3|Outcome|All Patients|
526583|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526584|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526585|NCT00267202|O3|Outcome|All Patients|
526586|NCT00267202|O2|Outcome|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526587|NCT00267202|O1|Outcome|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526588|NCT00267202|E2|Reported Event|Placebo|The dose of placebo was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526589|NCT00267202|E1|Reported Event|Omalizumab|The dose of omalizumab was determined according to the omalizumab US product label using a dosing table nomogram that ensures patients receive at least 0.016 mg/kg/IgE (IU/ml) per 4 weeks. The study drug was administered by subcutaneous injection every 2 or 4 weeks according to the dosing table nomogram.
526590|NCT00267189|B3|Baseline|Total|Total of all reporting groups
526591|NCT00267189|B2|Baseline|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
526592|NCT00267189|B1|Baseline|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
526593|NCT00267189|P2|Participant Flow|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
526594|NCT00267189|P1|Participant Flow|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
526595|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
526596|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
526597|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
526598|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
526599|NCT00267189|O2|Outcome|Group 2 (Control)|Standard CNI dose ± mycophenolate acid (MPA)/azathioprine (AZA) ± steroids
526600|NCT00267189|O1|Outcome|Group 1 (Everolimus)|Reduced or discontinued CNI dose + everolimus (3-12 ng/mL) ± steroids
526601|NCT00267189|E2|Reported Event|Group 2 (Control)|Standard calcineurin inhibitor dose ± mycophenolate acid/azathioprine ± steroids
526602|NCT00267189|E1|Reported Event|Group 1 (Everolimus)|Reduced calcineurin inhibitor dose + everolimus (1.5 mg twice daily) ± steroids
526603|NCT00267150|B1|Baseline|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
526604|NCT00267150|P1|Participant Flow|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
526605|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
526606|NCT00267150|O1|Outcome|Enteric Coated Mycophenolate-sodium|Enteric coated tablets of mycophenolate-sodium taken orally twice a day for 6-8 weeks.
526607|NCT00267150|E1|Reported Event|All Patients|All patients
526608|NCT00267111|B3|Baseline|Total|Total of all reporting groups
526609|NCT00267111|B2|Baseline|Placebo Group|1 g Eucerin plus was used as a placebo.
526610|NCT00267111|B1|Baseline|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
526611|NCT00267111|P2|Participant Flow|Placebo Group|1 g Eucerin plus was used as a placebo.
531624|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
526615|NCT00267111|O2|Outcome|Placebo Group|1 g Eucerin plus was used as a placebo
526616|NCT00267111|O1|Outcome|1 g Amethocaine Gel 4%|1 g Amethocaine gel 4% was used as the active drug
526617|NCT00267111|E2|Reported Event|Placebo Group|1 g Eucerin plus was used as a placebo.
526618|NCT00267111|E1|Reported Event|Amethocaine Gel 4% Group|1 g of topical amethocaine gel 4%.
526619|NCT00267098|B9|Baseline|Total|Total of all reporting groups
526620|NCT00267098|B8|Baseline|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
526621|NCT00267098|B7|Baseline|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
526622|NCT00267098|B6|Baseline|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
526623|NCT00267098|B5|Baseline|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
526624|NCT00267098|B4|Baseline|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
526625|NCT00267098|B3|Baseline|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
526626|NCT00267098|B2|Baseline|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
526627|NCT00267098|B1|Baseline|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
526628|NCT00267098|P8|Participant Flow|CRT-D: Not Randomized|Subjects successfully implanted with a CRT-D device who were not randomized
526629|NCT00267098|P7|Participant Flow|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
526630|NCT00267098|P6|Participant Flow|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
526631|NCT00267098|P5|Participant Flow|CRT-P: Not Randomized|Subjects successfully implanted with a CRT-P device who were not randomized
526632|NCT00267098|P4|Participant Flow|CRT-P: Right Ventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive right ventricular pacing
526633|NCT00267098|P3|Participant Flow|CRT-P: Biventricular Pacing Arm|Subjects who were implanted with a CRT-P device and randomized to receive biventricular pacing
526634|NCT00267098|P2|Participant Flow|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
526635|NCT00267098|P1|Participant Flow|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
526636|NCT00267098|O2|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
526637|NCT00267098|O1|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
526638|NCT00267098|O2|Outcome|Subjects With a CRT-D Implant Attempt|Subjects who underwent an implant attempt for a CRT-D device
526639|NCT00267098|O1|Outcome|Subjects With a CRT-P Implant Attempt|Subjects who underwent an implant attempt for a CRT-P device
526640|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
526641|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 24 month visit or did not miss their 24 month visit due to study closure
526642|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
526643|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 18 month visit or did not miss their 18 month visit due to study closure
526644|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
526645|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing who either worsened prior to the 12 month visit or did not miss their 12 month visit due to study closure
526646|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526647|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526648|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526649|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526650|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526651|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526652|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526653|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526654|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526655|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526656|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526657|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526658|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526659|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526660|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526661|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526662|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
531625|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
526663|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526664|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526665|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526666|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526667|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526668|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526669|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526670|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526671|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526672|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526673|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526674|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526675|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526676|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526677|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526678|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526679|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526680|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526681|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526682|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526683|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526684|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526685|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526686|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526687|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526688|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526689|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526690|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526691|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526692|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526693|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526694|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526695|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526696|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526697|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526698|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526699|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526700|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526701|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526702|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526703|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526704|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526705|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526706|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526707|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526708|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526709|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526710|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526711|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526712|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526713|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526714|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526715|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526716|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526717|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526718|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526719|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526720|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526721|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526722|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526723|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526724|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526725|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526726|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526727|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526728|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526729|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526730|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526731|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526732|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526733|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526734|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526735|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526736|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526737|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526738|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
526739|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
526740|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
526741|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
526742|NCT00267098|O4|Outcome|CRT-D: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing
526743|NCT00267098|O3|Outcome|CRT-D: Biventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive biventricular pacing
526744|NCT00267098|O2|Outcome|CRT-P: Right Ventricular Pacing Arm|Subjects implanted with a CRT-D device and randomized to receive right ventricular pacing.
526745|NCT00267098|O1|Outcome|CRT-P: Biventricular Pacing Arm|Subjects implanted with a CRT-P device and randomized to receive biventricular pacing
526746|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526747|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526748|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526749|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526750|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526751|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526752|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526753|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526754|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526755|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526756|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526757|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526758|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526759|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526760|NCT00267098|O2|Outcome|Right Ventricular Pacing Arm|Subjects randomized to receive right ventricular pacing.
526761|NCT00267098|O1|Outcome|Biventricular Pacing Arm|Subjects randomized to receive biventricular pacing
526762|NCT00267098|E5|Reported Event|No Implant Attempt|Subjects who did not undergo an implant attempt of a CRT-P or CRT-D device and were not randomized
526763|NCT00267098|E4|Reported Event|Unsuccessful Implants|Subjects who underwent an implant attempt of a CRT-P or CRT-D device but were not successfully implanted
526764|NCT00267098|E3|Reported Event|CRT: Not Randomized|Subjects successfully implanted with a CRT device who were not randomized
526765|NCT00267098|E2|Reported Event|Right Ventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive right ventricular pacing
526766|NCT00267098|E1|Reported Event|Biventricular Pacing Arm|Subjects who were implanted with a CRT device and randomized to receive biventricular pacing
526767|NCT00267085|B1|Baseline|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
526768|NCT00267085|P1|Participant Flow|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
526769|NCT00267085|O1|Outcome|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
526770|NCT00267085|E1|Reported Event|CML Vaccine|Imatinib mesylate subcutaneously every 2 weeks x 4 weeks, then every three weeks x 1 week, followed by monthly for 10 months
526771|NCT00267059|B1|Baseline|Lenalidomide|10 mg/day, orally once a day for 28 days
526772|NCT00267059|P1|Participant Flow|Lenalidomide|10 mg/day, orally once a day for 28 days
526773|NCT00267059|O1|Outcome|Lenalidomide|10 mg/day, orally once a day for 28 days
526774|NCT00267059|E1|Reported Event|Lenalidomide|10 mg/day, orally once a day for 28 days
526775|NCT00267046|B3|Baseline|Total|Total of all reporting groups
526776|NCT00267046|B2|Baseline|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526777|NCT00267046|B1|Baseline|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526778|NCT00267046|P2|Participant Flow|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526779|NCT00267046|P1|Participant Flow|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526780|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526781|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526782|NCT00267046|O2|Outcome|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526783|NCT00267046|O1|Outcome|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526784|NCT00267046|E2|Reported Event|Placebo|"Placebo + Chemotherapy (AI or AP Regimen):~AI = Doxorubicin (Adriamycin) + Ifosfamide:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~A single dose placebo 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526785|NCT00267046|E1|Reported Event|Palifermin|"Palifermin + Chemotherapy (AI or AP Regimen);~AI = Doxorubicin (Adriamycin) + Ifosfamide:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 intravenous (IV) for 72 hours starting Days 0 for total 90 mg/m^2. Ifosfamide 2.5 g/m^2 IV bolus Days 0-3 (total 10 g/m^2); Vincristine 2 mg IV Day 0.~AP=Doxorubicin (Adriamycin) + Cisplatin:~Palifermin 180 mcg/kg 3 days prior to chemotherapy; Adriamycin 30 mg/m^2 IV continuous infusion for 72 hours starting Day 0(total = 90 mg/m^2); Cisplatin 120 mg/m^2 on day 0."
526786|NCT00267007|B3|Baseline|Total|Total of all reporting groups
526787|NCT00267007|B2|Baseline|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
526788|NCT00267007|B1|Baseline|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
526789|NCT00267007|P2|Participant Flow|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
526790|NCT00267007|P1|Participant Flow|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
526791|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
526792|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
526793|NCT00267007|O2|Outcome|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
526794|NCT00267007|O1|Outcome|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
526795|NCT00267007|E2|Reported Event|Placebo|Equivalent volume to PROCRIT (1 mL) administered every week (QW) for 18 weeks (intravenous or subcutaneous)
526796|NCT00267007|E1|Reported Event|PROCRIT 40,000 IU QW|Epoetin alpha (PROCRIT) 40,000 IU every week (QW) for 18 weeks (intravenous or subcutaneous)
526798|NCT00266864|B2|Baseline|No Intervention|Subjects with normal testosterone levels (eugonadal) participated in identical outcome measurements at parallel time points.
526799|NCT00266864|B1|Baseline|Testosterone Replacement Therapy|Subjects with Low Testosterone (Hypogonadal) Receive Testosterone Transdermal System (Androderm 5 mg patch)
526800|NCT00266864|P2|Participant Flow|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
526801|NCT00266864|P1|Participant Flow|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
526802|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
526803|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Testosterone Replacement Therapy Patch 5 or 10 mg daily
526804|NCT00266864|O2|Outcome|No Intervention|Control group: subjects in this group will receive no intervention, but will have the same outcome measures as arm 1 completed at the baseline, 12, and 24 month time points.
526805|NCT00266864|O1|Outcome|Testosterone Replacement Therapy|Treatment group: Testosterone Replacement Therapy Patch 5 or 10mg daily (Androderm, Watson Pharma Inc.) for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range.
526806|NCT00266864|E1|Reported Event|Testosterone Replacement Therapy|A prospective, open-label, controlled drug intervention trial was performed in healthy hypogonadal and eugonadal outpatient men with chronic spinal cord injury (Treatment: serum testosterone concentration <4.0 mg/dL and Control: serum testosterone concentration ≥4.0 mg/dL). Treatment subjects received a transdermal testosterone patch (5 or 10 mg; Androderm, Watson Pharma Inc.) daily for 12 months, with the dose adjusted to raise the serum testosterone concentration to within the normal range. Only outcome measures were assessed for the no intervention arm; no adverse events were collected.
526807|NCT00266825|B3|Baseline|Total|Total of all reporting groups
526808|NCT00266825|B2|Baseline|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526809|NCT00266825|B1|Baseline|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526810|NCT00266825|P2|Participant Flow|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526811|NCT00266825|P1|Participant Flow|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526812|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526813|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526814|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526815|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526816|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526817|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526818|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526819|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526820|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526821|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526822|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526823|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526824|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526825|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526826|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526827|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526828|NCT00266825|O2|Outcome|DHA Supplement|"DHA capsule~DHA: 600 mg DHA"
526829|NCT00266825|O1|Outcome|Placebo Capsule|"Placebo capsule~Placebo capsule: Placebo capsule"
526830|NCT00266825|E4|Reported Event|DHA Capsule - Infant|Infants born from Mothers in the DHA capsule group
526831|NCT00266825|E3|Reported Event|DHA Capsule - Mother|"DHA capsule~DHA: 600 mg DHA"
526832|NCT00266825|E2|Reported Event|Placebo Capsule - Infant|Infants born from Mothers in the Placebo capsule group
526833|NCT00266825|E1|Reported Event|Placebo Capsule - Mother|"Placebo capsule~Placebo capsule: Placebo capsule"
526834|NCT00266812|B3|Baseline|Total|Total of all reporting groups
526835|NCT00266812|B2|Baseline|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
526836|NCT00266812|B1|Baseline|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
526837|NCT00266812|P2|Participant Flow|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
526838|NCT00266812|P1|Participant Flow|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
526839|NCT00266812|O2|Outcome|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
526840|NCT00266812|O1|Outcome|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
526841|NCT00266812|E2|Reported Event|Radiotherapy Alone|2 regimens are allowed: a) 20 fractions of 2 Gray each, on days 1 to 5, 8 to 12, 15 to 19, and 22 to 26; b) 10 fractions of 3 Gray each, administered on days 1 to 5 and 8 to 12.
526842|NCT00266812|E1|Reported Event|Chemotherapy With Temozolomide and Radiotherapy|Oral temozolomide 75mg/m2/day for 14 days, during radiation treatment, and later on temozolomide 100mg/m2/day at 14 days on/14 days off, until unacceptable toxicity or evidence of disease progression for up to 6 cycles from initial treatment. Radiotherapy (as in Intervention 2).
526843|NCT00266799|B3|Baseline|Total|Total of all reporting groups
526844|NCT00266799|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526845|NCT00266799|B1|Baseline|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526846|NCT00266799|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526847|NCT00266799|P1|Participant Flow|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526848|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526849|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526850|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526851|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526852|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526853|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526854|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526855|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526856|NCT00266799|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526857|NCT00266799|O1|Outcome|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526858|NCT00266799|E2|Reported Event|Capecitabine|Capecitabine 1250 mg/m^2, in tablets of 150 mg and 500 mg, was administered orally twice daily (BID) for 14 consecutive days followed by a 7-day rest period. Each cycle was repeated every 21 days until progress or unacceptable toxicity.
526859|NCT00266799|E1|Reported Event|Pegylated Liposomal Doxorubicin (PLD)|PLD 50 mg/m^2 was administered intravenously once every 28 days. Each cycle was repeated until progress or unacceptable toxicity.
526860|NCT00266695|B1|Baseline|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526861|NCT00266695|P1|Participant Flow|Ruboxistaurin|32 milligrams (mg) given once daily as an oral tablet for 2 years.
526862|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526863|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526864|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526865|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526866|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526867|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526868|NCT00266695|O1|Outcome|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526869|NCT00266695|E1|Reported Event|Ruboxistaurin|32 mg given once daily as oral tablet for 2 years.
526870|NCT00266656|B3|Baseline|Total|Total of all reporting groups
526871|NCT00266656|B2|Baseline|Early Untreated|Early untreated n=33
526872|NCT00266656|B1|Baseline|Early Treated|Early treated n=36
526873|NCT00266656|P2|Participant Flow|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526874|NCT00266656|P1|Participant Flow|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526875|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526876|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526877|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526878|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526909|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526879|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526880|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526881|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526882|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526883|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526884|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526885|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526886|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526887|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526888|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526889|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526890|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526891|NCT00266656|O2|Outcome|Early Untreated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526892|NCT00266656|O1|Outcome|Early Treated|"Humatrope administered according to investigator’s clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526893|NCT00266656|E2|Reported Event|Early Untreated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Control: Humatrope was not administered in B9R-US-GDFG (NCT00406926)."
526894|NCT00266656|E1|Reported Event|Early Treated|"Humatrope administered according to investigator's clinical practice and guided by the approved package insert.~Humatrope administered in B9R-US-GDFG (NCT00406926)."
526895|NCT00266630|B3|Baseline|Total|Total of all reporting groups
526896|NCT00266630|B2|Baseline|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526897|NCT00266630|B1|Baseline|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526898|NCT00266630|P2|Participant Flow|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526899|NCT00266630|P1|Participant Flow|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526900|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526901|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526902|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526903|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526904|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526905|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526906|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526907|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526908|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526910|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526911|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526912|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526913|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526914|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526915|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526916|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526917|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526918|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526919|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526920|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526921|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526922|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526923|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526924|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526925|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526926|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526927|NCT00266630|O2|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526928|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526929|NCT00266630|O1|Outcome|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526930|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526931|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526932|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526933|NCT00266630|O1|Outcome|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanzapine 5-20 mg for 18 weeks.
526934|NCT00266630|E2|Reported Event|Olanzapine + Mood Stabilizer|Olanzapine extension for Study BMAC patients who discontinued at Visit 4 or 5. Patients received an initial dose of olanzapine 10 mg for 1 week and subsequent doses of olanzapine 5-20 mg for 17 weeks. Patients received one (1) mood stabilizer (lithium, valproate or carbamazepine) for 18 weeks.
526935|NCT00266630|E1|Reported Event|Olanzapine Monotherapy|Olanzapine extension for Study BMAC patients who completed Visit 8. Patients received olanapine 5-20 mg for 18 weeks.
526936|NCT00264849|B3|Baseline|Total|Total of all reporting groups
526937|NCT00264849|B2|Baseline|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
527012|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527013|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
531626|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
526938|NCT00264849|B1|Baseline|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526939|NCT00264849|P2|Participant Flow|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526940|NCT00264849|P1|Participant Flow|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526941|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526942|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526943|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526944|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526945|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526946|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526947|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526948|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526949|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526950|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526951|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526952|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526953|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526954|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526955|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
527183|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
526956|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526957|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526958|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526959|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526960|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526961|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526962|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526963|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526964|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526965|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526966|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526967|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526968|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526969|NCT00264849|O2|Outcome|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526970|NCT00264849|O1|Outcome|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526971|NCT00264849|E2|Reported Event|Optimized Asthma Treatment (OAT)|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. In the treatment phase, participants continued to receive optimized asthma therapy (OAT) established during the run-in period of the study for an additional 32 weeks.
526972|NCT00264849|E1|Reported Event|OAT + Omalizumab|During the 8-week Run-in phase, asthma therapy was evaluated and optimized according to Global Initiative for Asthma (GINA) guidelines. During the treatment phase, participants continued to receive optimized asthma therapy (OAT), plus omalizumab add on therapy for 32 weeks, administered by subcutaneous injection once every 4 weeks. The dosage received was individualized based on body weight and serum IgE level.
526973|NCT00264810|B3|Baseline|Total|Total of all reporting groups
527014|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527015|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527016|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
526974|NCT00264810|B2|Baseline|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
526975|NCT00264810|B1|Baseline|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
526976|NCT00264810|P2|Participant Flow|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
526977|NCT00264810|P1|Participant Flow|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
526978|NCT00264810|O2|Outcome|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
526979|NCT00264810|O1|Outcome|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
526980|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System.
526981|NCT00264810|O1|Outcome|Implanted Subjects|Subjects implanted with the RNS® System
526982|NCT00264810|E2|Reported Event|Sham Group (Stimulation OFF)|Group of subjects that have undergone RNS® System implantation that are randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the Blinded Evaluation Period. Stimulation is enabled after transition into the Open Label Period (sixth month post-implant) and may continue for the remainder of the subject's participation in the study.
526983|NCT00264810|E1|Reported Event|Treatment Group (Stimulation ON)|Group of subjects that have undergone RNS® System implantation that are randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the Blinded Evaluation Period. Stimulation is enabled during the Stimulation Optimization Period (second month post-implant) and may continue throughout the subject's participation in the study.
526984|NCT00266409|B5|Baseline|Total|Total of all reporting groups
526985|NCT00266409|B4|Baseline|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
526986|NCT00266409|B3|Baseline|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
526987|NCT00266409|B2|Baseline|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
526988|NCT00266409|B1|Baseline|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
526989|NCT00266409|P4|Participant Flow|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
526990|NCT00266409|P3|Participant Flow|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
526991|NCT00266409|P2|Participant Flow|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
526992|NCT00266409|P1|Participant Flow|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
526993|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
526994|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
526995|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
526996|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
526997|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
526998|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
526999|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527000|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527001|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527002|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527003|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527004|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527005|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527006|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527007|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527008|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527009|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527010|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527011|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527017|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527018|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527019|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527020|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527021|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527022|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527023|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527024|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527025|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527026|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527027|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527028|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527029|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527030|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527031|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527032|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527033|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527034|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527035|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527036|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527037|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527038|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527039|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527040|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527041|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527042|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527043|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527044|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527045|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527046|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527047|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527048|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527049|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527050|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527051|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527052|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527053|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527054|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527055|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527056|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527057|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527058|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527059|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527060|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527061|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527062|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527063|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527064|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527065|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527066|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527067|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527068|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527069|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527070|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527071|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527127|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527072|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527073|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527074|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527075|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527076|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527077|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527078|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527079|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527080|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527081|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527082|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527083|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527084|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527085|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527086|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527087|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527088|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527089|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527090|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527091|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527092|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527093|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527094|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527095|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527096|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527097|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527098|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527099|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527100|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527101|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527102|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527103|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527104|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527105|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527106|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527107|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527108|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527109|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527110|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527111|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527112|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527113|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527114|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527115|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527116|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527117|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527118|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527119|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527120|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527121|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527122|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527123|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527124|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527125|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527126|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
531627|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
527128|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527129|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527130|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527131|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527132|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527133|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527134|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527135|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527136|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527137|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527138|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527139|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527140|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527141|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527142|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527143|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527144|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527145|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527146|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527147|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527148|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527149|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527150|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527151|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527152|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527153|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527154|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527155|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527156|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527157|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527158|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527159|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527160|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527161|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527162|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527163|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527164|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527165|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527166|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527167|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527168|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527169|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527170|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527171|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527172|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527173|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527174|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527175|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527176|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527177|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527178|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527179|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527180|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527181|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527182|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
531628|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
527184|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527185|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527186|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527187|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527188|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527189|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527190|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527191|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527192|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527193|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527194|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527195|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527196|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527197|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527198|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527199|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527200|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527201|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527202|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527203|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527204|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527205|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527206|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527207|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527208|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527209|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527210|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527211|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527212|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527213|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527214|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527215|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527216|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527217|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527218|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527219|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527220|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527221|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527222|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527223|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527224|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527225|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527226|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527227|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527228|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527229|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527230|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527231|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527232|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527233|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527234|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527235|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527236|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527237|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527238|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
531629|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
527239|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527240|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527241|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527242|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527243|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527244|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527245|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527246|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527247|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527248|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527249|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527250|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527251|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527252|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527253|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527254|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527255|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527256|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527257|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527258|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527259|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527260|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527261|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527262|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527263|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527264|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527265|NCT00266409|O4|Outcome|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527266|NCT00266409|O3|Outcome|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527267|NCT00266409|O2|Outcome|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527268|NCT00266409|O1|Outcome|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527269|NCT00266409|E4|Reported Event|GAD: SSRI/SNRI Alone|Generalized Anxiety Disorder: Newly prescribed SSRI or SNRI alone
527270|NCT00266409|E3|Reported Event|GAD : Niravam+SSRI/SNRI|Generalized Anxiety Disorder: Niravam plus newly prescribed SSRI or SNRI
527271|NCT00266409|E2|Reported Event|Panic: SSRI/SNRI Alone|Panic Disorder: Newly prescribed SSRI or SNRI alone
527272|NCT00266409|E1|Reported Event|Panic: Niravam+SSRI/SNRI|Panic Disorder: Niravam plus a newly prescribed SSRI or SNRI
527273|NCT00266279|B1|Baseline|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
527274|NCT00266279|P1|Participant Flow|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
527275|NCT00266279|O1|Outcome|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
527276|NCT00266279|E1|Reported Event|Treatment With Study Drugs|"Treatment with combination of oxaliplatin and capecitabine using study dose and schedule.~Oxaliplatin, Capecitabine : Agent, DOSE AND SCHEDULE (28-days cycle):~Oxaliplatin 85 mg/m2 IV on days 1 and 15 Capecitabine 1500 mg PO BID on days 1-7 and 15-21"
527277|NCT00266227|B3|Baseline|Total|Total of all reporting groups
527278|NCT00266227|B2|Baseline|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527279|NCT00266227|B1|Baseline|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527280|NCT00266227|P3|Participant Flow|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
527281|NCT00266227|P2|Participant Flow|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
527282|NCT00266227|P1|Participant Flow|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527928|NCT00264004|P4|Participant Flow|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527283|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527284|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527285|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527286|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527287|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527288|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527289|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527290|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527291|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527292|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527293|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527294|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527295|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527296|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527297|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527298|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527299|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527300|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527301|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527302|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527303|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527304|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527305|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527306|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527307|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527725|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527308|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527309|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527310|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527311|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527312|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527313|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527314|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527315|NCT00266227|O2|Outcome|Arm B: Placebo Re-treatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527316|NCT00266227|O1|Outcome|Arm A: Rituximab Re-treatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527317|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527318|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527319|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527320|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527321|NCT00266227|O2|Outcome|Arm B: Placebo Retreatment|1000 mg rituximab initial treatment on day 1 and day 15 plus 10-25 mg/wk methotrexate followed by re-treatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/wk methotrexate.
527322|NCT00266227|O1|Outcome|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527323|NCT00266227|E3|Reported Event|Rituximab-Not Randomized to Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate. Participants were not randomized to Retreatment.
527324|NCT00266227|E2|Reported Event|Arm B: Placebo Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by retreatment during weeks 24 -40 consisting of two doses of placebo 14 days apart plus 10-25 mg/week methotrexate.
527325|NCT00266227|E1|Reported Event|Arm A: Rituximab Retreatment|1000 mg rituximab intravenous initial treatment on day 1 and day 15 plus 10-25 mg/week methotrexate followed by re-treatment during weeks 24 -40 consisting of two additional doses of 1000 mg rituximab 14 days apart plus 10-25 mg/week methotrexate.
527326|NCT00264797|B3|Baseline|Total|Total of all reporting groups
527327|NCT00264797|B2|Baseline|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527328|NCT00264797|B1|Baseline|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527329|NCT00264797|P2|Participant Flow|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527358|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527330|NCT00264797|P1|Participant Flow|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527331|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527332|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527333|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527334|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527335|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527336|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527337|NCT00264797|O2|Outcome|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527338|NCT00264797|O1|Outcome|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527339|NCT00264797|E2|Reported Event|Methylphenidate (Placebo)|Methylphenidate (OROS-MPH) - Placebo : Participants will be scheduled for weekly medication and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH placebo for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527340|NCT00264797|E1|Reported Event|Methylphenidate|Methylphenidate (OROS-MPH) : Participants will be scheduled for weekly medication (OROS-MPH) and research assessment visits (approximately 45 minutes to 1 hour in length). A forced titration dosing strategy will be used starting with 18 mg/day OROS-MPH for 3 days, increasing to 36mg/day for the next three days; increasing to 54 mg/day in week two, and to 72 mg/day in week three through the remainder of the study (as tolerated). Participants will also attend weekly CBT sessions (approximately 1 hour in length) targeting their drug use.
527341|NCT00266032|B4|Baseline|Total|Total of all reporting groups
527342|NCT00266032|B3|Baseline|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527343|NCT00266032|B2|Baseline|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527404|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527929|NCT00264004|P3|Participant Flow|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527344|NCT00266032|B1|Baseline|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527345|NCT00266032|P3|Participant Flow|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527346|NCT00266032|P2|Participant Flow|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527347|NCT00266032|P1|Participant Flow|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527348|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527349|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527350|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527351|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527352|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527353|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527354|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527355|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527356|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527357|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527359|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527360|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527361|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527362|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527363|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527364|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527365|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527366|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527367|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527368|NCT00266032|O3|Outcome|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527369|NCT00266032|O2|Outcome|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527370|NCT00266032|O1|Outcome|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527371|NCT00266032|E3|Reported Event|Standard 24+4 Treatment of EE20/DRSP (YAZ, BAY86-5300)|13 cycles of treatment, each cycle comprising an intake of one tablet daily with 24 days of active tablets (20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone) followed by 4 days of placebo tablets, 13 withdrawal bleeding episodes during one year of treatment were expected.
527372|NCT00266032|E2|Reported Event|Fixed Extended Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days uninterrupted treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate plus 3 mg drospirenone followed by a 4 day tablet free interval, 3 withdrawal bleeding episodes during one year of treatment were expected.
527373|NCT00266032|E1|Reported Event|Flexible (Extended) Treatment of EE20/DRSP (YAZ, BAY86-5300)|3 cycles of treatment, each cycle comprising 120 days intended treatment with one tablet daily of 20µg ethinyl estradiol as betadex clathrate (EE20) plus 3 mg drospirenone (DRSP) followed by a 4 day tablet-free interval. If 3 consecutive days of bleeding and/or spotting occurred during the 120 day treatment period, a 4 day tablet free interval was advised. The minimum period between 2 tablet free intervals was 24 days. After each 4 day tablet free interval, a new 120 day intended treatment period was to be restarted, resulting in a minimum of 3 and maximum of 13 withdrawal bleeding episodes during one year of treatment.
527374|NCT00265889|B1|Baseline|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527375|NCT00265889|P1|Participant Flow|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527376|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527377|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527378|NCT00265889|O1|Outcome|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527379|NCT00265889|E1|Reported Event|Poor Risk Patients|Poor Risk (primary progressive, recurrent, or resistant relapse)
527380|NCT00265798|B1|Baseline|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527381|NCT00265798|P1|Participant Flow|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527382|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527383|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527384|NCT00265798|O1|Outcome|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527385|NCT00265798|E1|Reported Event|Sorafenib|Patients receive oral Sorafenib 400mg twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
527386|NCT00265785|B1|Baseline|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527387|NCT00265785|P1|Participant Flow|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527388|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527389|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527390|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527391|NCT00265785|O1|Outcome|Premetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527392|NCT00265785|E1|Reported Event|Pemetrexed|Pemetrexed Disodium 500 mg/m^2 intravenous (IV) over 10 min every 21 days until any of the following criteria is met: (1) Progression of disease or symptomatic deterioration; (2) Unacceptable toxicity; (3) Treatment delay ≥ 3 weeks, for any reason; (4) The patient may withdraw from the study at any time for any reason; (5) Physician's discretion.
527393|NCT00265616|B3|Baseline|Total|Total of all reporting groups
527394|NCT00265616|B2|Baseline|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527395|NCT00265616|B1|Baseline|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527396|NCT00265616|P2|Participant Flow|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG); no maximum doses defined.
527397|NCT00265616|P1|Participant Flow|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG);no maximum doses defined.
527398|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527399|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527400|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527401|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527402|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527403|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
531630|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
527405|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527406|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527407|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527408|NCT00265616|O2|Outcome|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527409|NCT00265616|O1|Outcome|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527410|NCT00265616|E2|Reported Event|Thiopental/Pentobarbital|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527411|NCT00265616|E1|Reported Event|Propofol|titrated to electroencephalographic burst-suppression (intravenous load as per protocol, then following the EEG)
527412|NCT00265512|B3|Baseline|Total|Total of all reporting groups
527413|NCT00265512|B2|Baseline|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
527414|NCT00265512|B1|Baseline|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
527415|NCT00265512|P2|Participant Flow|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
527416|NCT00265512|P1|Participant Flow|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
527417|NCT00265512|O2|Outcome|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment."
527418|NCT00265512|O1|Outcome|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months."
527419|NCT00265512|E2|Reported Event|Arm 2|"Continuing Care as Usual~Continuing Care as Usual: Continuing Care as Usual will include standard group outpatient SUD treatment.~SAEs were tracked, but AEs were not tracked."
527420|NCT00265512|E1|Reported Event|Arm 1|"Telephone Case Monitoring Aftercare~Telephone Case Monitoring: Telephone Case Monitoring involves telephone delivery of continuing care treatment post intensive outpatient SUD treatment. It includes brief weekly phone calls with a counselor for up to 6 months.~SAEs were tracked, but AEs were not tracked."
527421|NCT00265473|B1|Baseline|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
527422|NCT00265473|P1|Participant Flow|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
527423|NCT00265473|O1|Outcome|Experimental|Islet infusion
527424|NCT00265473|O1|Outcome|Experimental|Islet infusion
527425|NCT00265473|O1|Outcome|Experimental|Islet infusion
527426|NCT00265473|O1|Outcome|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
527427|NCT00265473|O1|Outcome|Experimental|Islet infusion
527428|NCT00265473|E1|Reported Event|Experimental|Islet infusion with MGA031 induction and sirolimus and tacrolimus maintenance immunosuppression.
527429|NCT00265395|B3|Baseline|Total|Total of all reporting groups
527430|NCT00265395|B2|Baseline|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
527431|NCT00265395|B1|Baseline|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
527432|NCT00265395|P2|Participant Flow|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
527433|NCT00265395|P1|Participant Flow|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
527434|NCT00265395|O2|Outcome|Extended Therapy (72-week Treatment)|Slow responders (defined as being PCR positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to continue treatment to Week 72.
527435|NCT00265395|O1|Outcome|Standard Therapy (48-week Treatment)|Slow responders (defined as being polymerase chain reaction [PCR] positive at Week 12 with at least 2 log reduction in viral load and PCR negative at Week 24) who are randomized at Week 48 to stop treatment at Week 48.
527436|NCT00265395|E1|Reported Event|Standard Therapy (48-week Treatment)|
527437|NCT00265382|B1|Baseline|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527438|NCT00265382|P1|Participant Flow|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527439|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527440|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527441|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527442|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527443|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527444|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527445|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527446|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527447|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527448|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527449|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527450|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527451|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527452|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527453|NCT00265382|O1|Outcome|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 mg/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kg. For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527454|NCT00265382|E1|Reported Event|Ziprasidone|Titrated over a 2-week period, starting with an evening dose of 20 milligrams (mg)/day, and subsequent dose increases of 20 mg/day every second day up to a target dose of 80 to 160 mg/day for subjects weighing > = 45 kilograms (kg). For subjects with a body weight < 45 kg, the maximum permitted dose was 80 mg/day (40 mg twice a day [BID]). Doses could have been reduced to a minimum of 40 mg/day (20 mg BID).
527455|NCT00265343|B3|Baseline|Total|Total of all reporting groups
527456|NCT00265343|B2|Baseline|Olanzapine|5-20 mg daily (QD) orally (PO)
527457|NCT00265343|B1|Baseline|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
527458|NCT00265343|P2|Participant Flow|Olanzapine|5-20 mg daily (QD) orally (PO)
527459|NCT00265343|P1|Participant Flow|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
527460|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
527461|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
527462|NCT00265343|O2|Outcome|Olanzapine|5-20 mg daily (QD) orally (PO)
527463|NCT00265343|O1|Outcome|Asenapine|5-10 mg twice daily (bid) sublingual (SL)
527464|NCT00265343|E2|Reported Event|Olanzapine|
527465|NCT00265343|E1|Reported Event|Asenapine|
527510|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527466|NCT00265330|B1|Baseline|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527467|NCT00265330|P1|Participant Flow|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527468|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527469|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527470|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527471|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527472|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527473|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527474|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527475|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527476|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527477|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527478|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527479|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527480|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527481|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527482|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527726|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527483|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527484|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527485|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527486|NCT00265330|O1|Outcome|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527487|NCT00265330|E1|Reported Event|Ziprasidone|Dosing was flexible, with dosing adjustments made at the discretion of the investigator to maintain optimal efficacy and tolerability. For subjects having a body weight of 45 kilograms (kg) or greater, the target dosage range was 40-80 milligrams (mg) twice per day (BID) (80-160 mg/day). For subjects having a body weight under 45 kg, the maximum permitted dose was 80 mg/day (40 mg BID).
527488|NCT00265317|B5|Baseline|Total|Total of all reporting groups
527489|NCT00265317|B4|Baseline|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527490|NCT00265317|B3|Baseline|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
527491|NCT00265317|B2|Baseline|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
527492|NCT00265317|B1|Baseline|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
527493|NCT00265317|P4|Participant Flow|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527494|NCT00265317|P3|Participant Flow|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
527495|NCT00265317|P2|Participant Flow|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
527496|NCT00265317|P1|Participant Flow|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
527497|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527498|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527499|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527500|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527501|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527502|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527503|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527504|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527505|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527506|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527507|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527508|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527509|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527511|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527512|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527513|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527514|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527515|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527516|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527517|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527518|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527519|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527520|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527521|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527522|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527523|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527524|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527525|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527526|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527527|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527528|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527529|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
527530|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527531|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527532|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527533|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527534|NCT00265317|O1|Outcome|All Participants|All participants in all phases
527535|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527536|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527537|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527538|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527539|NCT00265317|O1|Outcome|All Participants|All participants in all phases.
527540|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527541|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527542|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527543|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527544|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527545|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527546|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527547|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527548|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527549|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527550|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527551|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527552|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527553|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527554|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527555|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527556|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527557|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527558|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527559|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527560|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527561|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527562|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527563|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527564|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527565|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527566|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527567|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527568|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527569|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (All Combined)|Combined Data from all participants in the Original Lead-In Cohort, Amended Lead-In Cohort (Arms A and B), and Randomized Cohort
527570|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527571|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527572|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527573|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527574|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527642|NCT00265122|O2|Outcome|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
527575|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days)and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
527576|NCT00265317|O2|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527577|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527578|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527579|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527580|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527581|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527582|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527583|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527584|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527585|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527586|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527587|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527588|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527589|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527590|NCT00265317|O1|Outcome|Sunitinib+Erlotinib (Amended Lead-In Arm B)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (13 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (26 days in Cycle 1)
527591|NCT00265317|O1|Outcome|Sunitinib + Erlotinib (Amended Lead-In Arm A)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1).
527592|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527593|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527594|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527595|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527596|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527597|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527598|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527599|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527600|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527601|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527602|NCT00265317|O2|Outcome|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527603|NCT00265317|O1|Outcome|Sunitinib + Erlotinib|Erlotinib 150 mg oral tablets once daily (QD) in a continuous regimen expressed in 4-week cycles and Sunitinib 37.5 mg oral capsules QD in a continuous regimen expressed in 4-week cycles.
527604|NCT00265317|E4|Reported Event|Erlotinib + Placebo|Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles and Placebo oral capsules QD in a continuous regimen expressed in 4-week cycles.
527722|NCT00264576|B1|Baseline|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527605|NCT00265317|E3|Reported Event|Sunitinib + Erlotinib|Sunitinib oral capsules, 37.5 mg QD in a continuous regimen, expressed in 4-week cycles and Erlotinib 150 mg oral tablets QD in a continuous regimen expressed in 4-week cycles.
527606|NCT00265317|E2|Reported Event|Sunitinib + Erlotinib (Amended Lead-in)|Sunitinib 37.5 mg oral capsules QD for 28 days each cycle (27 days in Cycle 1, Arm A or 13 days in Cycle 1, Arm B) and Erlotinib 150 mg oral tablets QD for 28 days each cycle (7 days in Cycle 1, Arm A or 26 days in Cycle 1, Arm B)
527607|NCT00265317|E1|Reported Event|Sunitinib + Erlotinib (Original Lead-In)|Sunitinib 37.5 mg oral capsules once daily (QD) for 28 days each cycle with exception of Cycle 2 (27 days) and Erlotinib 150 mg oral tablets QD for 28 days each cycle with exception of Cycle 1 (35 days).
527608|NCT00265239|B3|Baseline|Total|Total of all reporting groups
527609|NCT00265239|B2|Baseline|Placebo Group|Placebo Group
527610|NCT00265239|B1|Baseline|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527611|NCT00265239|P2|Participant Flow|Placebo Group|Placebo Group
527612|NCT00265239|P1|Participant Flow|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527613|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
527614|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527615|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
527616|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527617|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
527618|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527619|NCT00265239|O2|Outcome|Placebo Group|Placebo Group
527620|NCT00265239|O1|Outcome|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527621|NCT00265239|E2|Reported Event|Placebo Group|Placebo Group
527622|NCT00265239|E1|Reported Event|Edaravone Group|"Edaravone Group~edaravone: intravenous administration of 30mg Edaravone just before reperfusion therapy"
527623|NCT00265122|B7|Baseline|Total|Total of all reporting groups
527624|NCT00265122|B6|Baseline|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
527625|NCT00265122|B5|Baseline|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
527626|NCT00265122|B4|Baseline|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
527627|NCT00265122|B3|Baseline|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
527628|NCT00265122|B2|Baseline|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527629|NCT00265122|B1|Baseline|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527630|NCT00265122|P6|Participant Flow|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
527631|NCT00265122|P5|Participant Flow|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
527632|NCT00265122|P4|Participant Flow|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
527633|NCT00265122|P3|Participant Flow|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
527634|NCT00265122|P2|Participant Flow|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527635|NCT00265122|P1|Participant Flow|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527636|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab SC and Ustekinumab IV
527637|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All participants who received Placebo SC and Placebo IV
527638|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
527639|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
527640|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527641|NCT00265122|O1|Outcome|Population 1:Placebo SC Followed by Ustekinumab 90 mg SC|Participants received subcutaneous (SC) injections of placebo at Weeks 0, 1, 2, 3 (Intervention Period 1: Weeks 0-8), and 90 mg ustekinumab SC at Weeks 8, 9, 10 and 11 (Intervention Period 2: Weeks 8-28)
527643|NCT00265122|O1|Outcome|Population 2: Ustekinumab 90 SC|Paticipants received ustekinumab 90 mg subcutaneously (SC) at Weeks 0, 1, 2, and 3 (Intervention Period 1: Weeks 0-8), and did not receive any study agent from Week 8 onward (Intervention Period 2: Weeks 8-28)
527644|NCT00265122|O6|Outcome|Population 1: Ustekinumab SC and IV Combined|All participants who received Ustekinumab 90 mg SC and Ustekinumab 4.5 mg/kg IV
527645|NCT00265122|O5|Outcome|Population 1: Placebo SC and IV Combined|All particpants who received Placebo SC and Placebo IV
527646|NCT00265122|O4|Outcome|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2.
527647|NCT00265122|O3|Outcome|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2.
527648|NCT00265122|O2|Outcome|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527649|NCT00265122|O1|Outcome|Population 1: Placebo SC Followed by Ustekinumab SC|Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527650|NCT00265122|E6|Reported Event|Population 2: Ustekinumab 4.5 mg/kg IV|Ustekinumab 4.5 mg given as one intravenous (IV) infusion at Week 0 during Intervention Period 1. No intervention given during Intervention Period 2.
527651|NCT00265122|E5|Reported Event|Population 2: Ustekinumab 90 mg SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week at Weeks 0-3 during Intervention Period 1. No intervention given during Intervention Period 2.
527652|NCT00265122|E4|Reported Event|Population 1: Ustekinumab 4.5 mg/kg IV Followed by Placebo IV|"Ustekinumab 4.5 mg/kg given as one intravenous(IV) infusion at Week 0 during Intervention Period 1 followed by placebo given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 26 participants randomized to this treatment group + 1 participant randomized to treatment with Placebo IV followed by Ustekinumab 4.5 mg/kg IV who received ustekinumab IV at Week 0 was included in the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
527653|NCT00265122|E3|Reported Event|Population 1: Placebo IV Followed by Ustekinumab 4.5 mg/kg IV|"Placebo given as 1 intravenous (IV) infusion at Week 0 during Intervention Period 1 and ustekinumab 4.5 mg/kg given as one IV infusion at Week 8 during Intervention Period 2. NOTE: 8 of 27 participants randomized to this treatment group were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below for the following reasons: 7 participants received placebo only were excluded from the analysis of adverse events and 1 participant received ustekinumab IV at Week 0 and was included in the analysis of adverse events in the treatment group labelled Ustekinumab 4.5 mg/kg IV followed by Placebo IV."
527654|NCT00265122|E2|Reported Event|Population 1: Ustekinumab 90 mg SC Followed by Placebo SC|Ustekinumab 90 mg injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by placebo SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2.
527655|NCT00265122|E1|Reported Event|Population 1: Placebo SC Followed by Ustekinumab SC|"Placebo injected subcutaneously (SC) once a week for 4 weeks (Weeks 0-3) during Intervention Period 1 followed by ustekinumab 90 mg SC once a week for 4 weeks (Weeks 8-11) during Intervention Period 2. NOTE: 4 of 26 participants randomized to this treatment group received placebo only and were excluded from the Total # at Risk by any Serious Adverse Event and Total # at Risk by any Other Adverse Event listed below."
527656|NCT00265109|B1|Baseline|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
527657|NCT00265109|P1|Participant Flow|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
527658|NCT00265109|O1|Outcome|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
527659|NCT00265109|E1|Reported Event|Open-Label Levetiracetam|All 17 participants in the study received Levetiracetam. The initial dose was 250 mg/day, which was increased to 250 mg BID after 1 week. The dose was then increased by 500 mg/day each week (given in BID dosing) to a maximum of 3,000 mg/day. The dose was raised more slowly or the maximum dose was not reached if response occurred at a lower dose or side effects were problematic.
527660|NCT00265096|B4|Baseline|Total|Total of all reporting groups
527661|NCT00265096|B3|Baseline|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
527662|NCT00265096|B2|Baseline|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527663|NCT00265096|B1|Baseline|Group 1: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527664|NCT00265096|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
527723|NCT00264576|P2|Participant Flow|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527665|NCT00265096|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527666|NCT00265096|P1|Participant Flow|Group 1: Placebo|Group 1: Placebo Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527667|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527668|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
527669|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527670|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527671|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527672|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
527673|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527674|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527675|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527676|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527677|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527678|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527679|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527680|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527681|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527682|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527683|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527684|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527685|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527686|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527687|NCT00265096|O4|Outcome|Combined: Group II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527688|NCT00265096|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 weeks from Wk 0 up to 5 yrs.
527689|NCT00265096|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 weeks from Wk 0 through 5 yrs (unless early escape at Wk 16); golimumab - if early escape, 100 mg SC injection every 4 weeks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527724|NCT00264576|P1|Participant Flow|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527690|NCT00265096|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks from week (Wk) 0 through Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC injection from Wk 16 up to 5 years (yrs); golimumab - 50 mg SC injection beginning Wk 24 up to 5 yrs (unless early escape); golimumab - Doctor's (Dr's) discretion after unblinding (last patient completes the Wk 52 evaluation and database is locked), dose adjust from 50 to 100 mg.
527691|NCT00265096|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
527692|NCT00265096|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
527693|NCT00265096|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
527694|NCT00265083|B4|Baseline|Total|Total of all reporting groups
527695|NCT00265083|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527696|NCT00265083|B2|Baseline|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527697|NCT00265083|B1|Baseline|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527698|NCT00265083|P3|Participant Flow|Group 3: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527699|NCT00265083|P2|Participant Flow|Group 2: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527700|NCT00265083|P1|Participant Flow|Group 1: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527701|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527702|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527703|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527704|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527705|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527706|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527707|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527708|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527709|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527710|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527711|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527712|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527713|NCT00265083|O4|Outcome|Combined: Groups II & III|Combines Group II (golimumab 50 mg) and Group III (golimumab 100 mg).
527714|NCT00265083|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 100 mg SC injections every 4 wks from Wk 0 up to 5 yrs.
527715|NCT00265083|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 50 mg SC injections every 4 wks from Wk 0 thru 5 yrs (unless early escape at Wk 16); golimumab - If early escape, 100 mg SC every 4 wks beginning Wk 16 up to 5 yrs; golimumab - Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527716|NCT00265083|O1|Outcome|Group I: Placebo|Placebo SC injections every 4 weeks (wks) from Week (Wk) 0 thru Wk 20 (unless early escape at Wk 16); golimumab - if early escape, 50 mg SC every 4 wks from Wk 16 up to 5 yrs; golimumab - 50 mg SC beginning Wk 24 up to 5 yrs (unless early escape); golimumab- Dr's discretion after unblinding, dose adjust from 50 to 100 mg.
527717|NCT00265083|E3|Reported Event|Group 3: Golimumab 50 and 100 mg|Subjects who were treated with Golimumab and received at least one injection of both Golimumab 50 mg and Golimumab 100 mg.
527718|NCT00265083|E2|Reported Event|Group 2: Golimumab 100 mg|Subjects who were treated with Golimumab and received Golimumab 100 mg injections only.
527719|NCT00265083|E1|Reported Event|Group 1: Golimumab 50 mg|Subjects who were treated with Golimumab and received Golimumab 50 mg injections only.
527720|NCT00264576|B3|Baseline|Total|Total of all reporting groups
527721|NCT00264576|B2|Baseline|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
531631|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
527727|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527728|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527729|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527730|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527731|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527732|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell- culture-derived trivalent influenza vaccine (cTIV).
527733|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527734|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527735|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527736|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527737|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527738|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527739|NCT00264576|O2|Outcome|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527740|NCT00264576|O1|Outcome|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527741|NCT00264576|E2|Reported Event|eTIV_f|Adults 18 to < 50 years of age received one dose of egg-derived trivalent vaccine (eTIV_f).
527742|NCT00264576|E1|Reported Event|cTIV|Adults 18 to < 50 years of age received one dose of cell-culture-derived trivalent influenza vaccine (cTIV).
527743|NCT00264550|B5|Baseline|Total|Total of all reporting groups
527744|NCT00264550|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527745|NCT00264550|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527746|NCT00264550|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527747|NCT00264550|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527748|NCT00264550|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527749|NCT00264550|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527750|NCT00264550|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527751|NCT00264550|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527752|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527753|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527862|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
531632|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
527754|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527755|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527756|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527757|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527758|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527759|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527760|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527761|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527762|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527763|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527764|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527765|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527766|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527767|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527768|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527769|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527863|NCT00264303|E2|Reported Event|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527770|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527771|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527772|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527773|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527774|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527775|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527776|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527777|NCT00264550|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527778|NCT00264550|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527779|NCT00264550|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 up to 5 yrs (unless early escape at Week 16); Methotrexate - 15 to 25 mg weekly from Week 0 up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527780|NCT00264550|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 up to 5 yrs; Placebo - 7 to 10 capsules weekly during blinded period (or Week 16 if early escape); Methotrexate - if early escape, 15 to 25mg weekly from Week 16 up to 5 yrs; Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527781|NCT00264550|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous (SC) injections every 4 weeks from Week 0 to Week 20 (early escape at Week 16); Methotrexate - 15 to 25mg weekly from Week 0 up to 5 yrs; Golimumab - if early escape, 50mg SC injections every 4 weeks from Week 16 up to 5 years; Golimumab - 50 mg SC injections every 4 weeks from Week 24 up to 5 yrs (unless early escape); Methotrexate - Dr's discretion, weekly dose adjusted after unblinding; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527782|NCT00264550|E3|Reported Event|Group 3: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study.
527783|NCT00264550|E2|Reported Event|Group 2: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study.
527784|NCT00264550|E1|Reported Event|Group 1: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study.
527785|NCT00264537|B5|Baseline|Total|Total of all reporting groups
527786|NCT00264537|B4|Baseline|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527787|NCT00264537|B3|Baseline|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527788|NCT00264537|B2|Baseline|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527789|NCT00264537|B1|Baseline|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527790|NCT00264537|P4|Participant Flow|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527791|NCT00264537|P3|Participant Flow|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527792|NCT00264537|P2|Participant Flow|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527793|NCT00264537|P1|Participant Flow|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527794|NCT00264537|O5|Outcome|Combined: Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527795|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527796|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527797|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527798|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527799|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527800|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527801|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527802|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527864|NCT00264303|E1|Reported Event|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527865|NCT00264290|B3|Baseline|Total|Total of all reporting groups
527930|NCT00264004|P2|Participant Flow|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527803|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527804|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527805|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate (MTX)|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527806|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527807|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527808|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527809|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527810|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527811|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527812|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527813|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527814|NCT00264537|O5|Outcome|Combined Golimumab + Methotrexate|Combines Group 3 (golimumab 50 mg + methotrexate) and Group 4 (golimumab 100 mg + methotrexate)
527815|NCT00264537|O4|Outcome|Group 4: Golimumab 100 mg + Methotrexate|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527816|NCT00264537|O3|Outcome|Group 3: Golimumab 50 mg + Methotrexate|Golimumab 50 mg SC injections every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 100 mg SC injections every 4 weeks from Week 28 for up to 5 yrs; Golimumab - Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527817|NCT00264537|O2|Outcome|Group 2: Golimumab 100 mg + Placebo|Golimumab 100 mg SC injections every 4 weeks from Week 0 for up to 5 years; placebo capsules weekly from Week 0 for up to 5 years (unless early escape at Week 28); Methotrexate - if early escape, 10 to 20 mg weekly from Week 28 up to 5 years; Methotrexate – Dr’s discretion after unblinding (in participants receiving golimumab plus placebo) 10 to 20 mg weekly for up to 5 years; Golimumab - Dr's discretion after unblinding, dose adjusted from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527818|NCT00264537|O1|Outcome|Group 1: Placebo + Methotrexate|Placebo subcutaneous injections (SC) every 4 weeks from Week 0 for up to 5 years (unless early escape at week 28); Methotrexate - 10 to 20 mg weekly from Week 0 for up to 5 years; Golimumab - if early escape, 50 mg SC injections every 4 weeks from Week 28 up to 5 years; Golimumab – Dr’s discretion after unblinding (in participants receiving methotrexate plus placebo), 50 mg SC injections every 4 weeks up to 5 years; Golimumab- Dr's discretion after unblinding, dose adjusted from 50 to 100 mg and from 100 to 50mg. Duration of the blinded period was until the week-52 database lock.
527927|NCT00264004|B1|Baseline|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527819|NCT00264537|E3|Reported Event|Group C: Golimumab 50 and 100 mg SC Injections|Participants who were treated with golimumab and received at least one injection of both golimumab 50 mg and golimumab 100 mg during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2, Group 3 and Group 4, who received Golimumab 50 mg and 100 mg SC Injections.
527820|NCT00264537|E2|Reported Event|Group B: Golimumab 100 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 100 mg injections only during the study. Participants also received either methotrexate or placebo capsules throughout the study. Participants were included from Group 1, Group 2 and Group 4, who received only Golimumab 100 mg SC Injections.
527821|NCT00264537|E1|Reported Event|Group A: Golimumab 50 mg SC Injections Only|Participants who were treated with golimumab and received golimumab 50 mg injections only during the study. Participants also received methotrexate capsules throughout the study. Participants were included from Group 1 and Group 3, who received only Golimumab 50 mg SC Injections.
527822|NCT00264498|B3|Baseline|Total|Total of all reporting groups
527823|NCT00264498|B2|Baseline|Experimental|Gefitinib
527824|NCT00264498|B1|Baseline|Active Comparator|Gemcitabine + Carboplatin
527825|NCT00264498|P2|Participant Flow|Experimental|Gefitinib
527826|NCT00264498|P1|Participant Flow|Active Comparator|Gemcitabine + Carboplatin
527827|NCT00264498|O2|Outcome|Experimental|Gefitinib
527828|NCT00264498|O1|Outcome|Active Comparator|Gemcitabine + Carboplatin
527829|NCT00264498|E2|Reported Event|Experimental|Gefitinib
527830|NCT00264498|E1|Reported Event|Active Comparator|Gemcitabine + Carboplatin
527831|NCT00264381|B3|Baseline|Total|Total of all reporting groups
527832|NCT00264381|B2|Baseline|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527833|NCT00264381|B1|Baseline|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527834|NCT00264381|P2|Participant Flow|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527835|NCT00264381|P1|Participant Flow|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527836|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527837|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527838|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527839|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527840|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527841|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527842|NCT00264381|O2|Outcome|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527843|NCT00264381|O1|Outcome|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527844|NCT00264381|E2|Reported Event|Dalteparin 200 U/kg Then 10,000 U Daily|"Dalteparin 200 units/kg subcutaneously injection on day one then 10,000 units daily for 6 additional doses + placebo orally for 7 days~+ additional 7 days of same therapy based on results of ultrasound at day 7"
527845|NCT00264381|E1|Reported Event|Ibuprofen 800 mg Tid|"Ibuprofen 800mg orally tid for 7 days + one placebo injection daily for 7 days~+ additional 7 days of same therapy based on result of ultrasound at day 7"
527846|NCT00264303|B3|Baseline|Total|Total of all reporting groups
527847|NCT00264303|B2|Baseline|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527848|NCT00264303|B1|Baseline|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527849|NCT00264303|P2|Participant Flow|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527850|NCT00264303|P1|Participant Flow|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527851|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527852|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527853|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527854|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527855|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527856|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527857|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527858|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527859|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527860|NCT00264303|O1|Outcome|Levocetirizine 5 mg|Levocetirizine 5 mg once daily for four weeks
527861|NCT00264303|O2|Outcome|Desloratadine 5 mg|Desloratadine 5 mg once daily for four weeks
527866|NCT00264290|B2|Baseline|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
527867|NCT00264290|B1|Baseline|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
527868|NCT00264290|P2|Participant Flow|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone."
527869|NCT00264290|P1|Participant Flow|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background antiretroviral (ARV) regimen alone.
527870|NCT00264290|O2|Outcome|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
527871|NCT00264290|O1|Outcome|Placebo|placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
527872|NCT00264290|E2|Reported Event|Valganciclovir|"900mg PO qd~Valganciclovir : 900mg PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone."
527873|NCT00264290|E1|Reported Event|Placebo|Placebo PO qd x 8 weeks followed by 4 weeks of observation on background ARV regimen alone.
527874|NCT00264147|B6|Baseline|Total|Total of all reporting groups
527875|NCT00264147|B5|Baseline|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527876|NCT00264147|B4|Baseline|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527877|NCT00264147|B3|Baseline|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527878|NCT00264147|B2|Baseline|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527879|NCT00264147|B1|Baseline|Placebo|Treatment I: Placebo orally once daily
527880|NCT00264147|P6|Participant Flow|Diclofenac 150 mg (Treatment II)|Treatment II: Diclofenac 75 mg orally twice daily
527881|NCT00264147|P5|Participant Flow|Etoricoxib 90 mg|Treatment I and II: Etoricoxib 90 mg orally once daily
527882|NCT00264147|P4|Participant Flow|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527883|NCT00264147|P3|Participant Flow|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527884|NCT00264147|P2|Participant Flow|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527885|NCT00264147|P1|Participant Flow|Placebo|Treatment I: Placebo orally once daily
527886|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527887|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527888|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527889|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527890|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527891|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527892|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527893|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527894|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527895|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527896|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527897|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527898|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527899|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527900|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527901|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527902|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527903|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527904|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527905|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527906|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527907|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527908|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527909|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527910|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527911|NCT00264147|O5|Outcome|Etoricoxib 90 mg|Treatment I: Etoricoxib 90 mg orally once daily
527912|NCT00264147|O4|Outcome|Etoricoxib 60 mg|Treatment I: Etoricoxib 60 mg orally once daily
527913|NCT00264147|O3|Outcome|Etoricoxib 30 mg|Treatment I: Etoricoxib 30 mg orally once daily
527914|NCT00264147|O2|Outcome|Etoricoxib 10 mg|Treatment I: Etoricoxib 10 mg orally once daily
527915|NCT00264147|O1|Outcome|Placebo|Treatment I: Placebo orally once daily
527916|NCT00264147|E7|Reported Event|Diclofenac 150 mg Treatment II Period|Treatment II: Diclofenac 75 mg orally twice daily
527917|NCT00264147|E6|Reported Event|Etoricoxib 90 mg Treatment II Period|Treatment II: Etoricoxib 90 mg orally once daily
527918|NCT00264147|E5|Reported Event|Etoricoxib 90 mg Treatment I Period|Treatment I: Etoricoxib 90 mg orally once daily
527919|NCT00264147|E4|Reported Event|Etoricoxib 60 mg Treatment I Period|Treatment I: Etoricoxib 60 mg orally once daily
527920|NCT00264147|E3|Reported Event|Etoricoxib 30 mg Treatment I Period|Treatment I: Etoricoxib 30 mg orally once daily
527921|NCT00264147|E2|Reported Event|Etoricoxib 10 mg Treatment I Period|Treatment I: Etoricoxib 10 mg orally once daily
527922|NCT00264147|E1|Reported Event|Placebo Treatment I Period|Treatment I: Placebo orally once daily
527923|NCT00264004|B5|Baseline|Total|Total of all reporting groups
527924|NCT00264004|B4|Baseline|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527925|NCT00264004|B3|Baseline|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527926|NCT00264004|B2|Baseline|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527931|NCT00264004|P1|Participant Flow|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527932|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527933|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527934|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527935|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527936|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527937|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527938|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527939|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527940|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527941|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527942|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527943|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527944|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527945|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527946|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527947|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527948|NCT00264004|O4|Outcome|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527949|NCT00264004|O3|Outcome|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527950|NCT00264004|O2|Outcome|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527951|NCT00264004|O1|Outcome|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527952|NCT00264004|E4|Reported Event|AZD2171 45 mg No Anti HT|AZD2171 45 mg No AntiHT prophylaxis
527953|NCT00264004|E3|Reported Event|AZD2171 45 mg Anti HT|AZD2171 45 mg AntiHT prophylaxis
527954|NCT00264004|E2|Reported Event|AZD2171 30 mg No Anti HT|AZD2171 30 mg No AntiHT prophylaxis
527955|NCT00264004|E1|Reported Event|AZD2171 30 mg Anti HT|AZD2171 30 mg AntiHT prophylaxis
527956|NCT00263887|B3|Baseline|Total|Total of all reporting groups
527957|NCT00263887|B2|Baseline|Placebo|
527958|NCT00263887|B1|Baseline|Prolastin (60 mg/kg Body Weight)|
527959|NCT00263887|P2|Participant Flow|Placebo|
527960|NCT00263887|P1|Participant Flow|Prolastin (60 mg/kg Body Weight)|
527961|NCT00263887|O2|Outcome|Placebo|
527962|NCT00263887|O1|Outcome|Prolastin (60 mg/kg Body Weight)|
527963|NCT00263887|E2|Reported Event|Placebo|
527964|NCT00263887|E1|Reported Event|Prolastin (60 mg/kg Body Weight)|
527965|NCT00263757|B3|Baseline|Total|Total of all reporting groups
527966|NCT00263757|B2|Baseline|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527967|NCT00263757|B1|Baseline|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527968|NCT00263757|P2|Participant Flow|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527969|NCT00263757|P1|Participant Flow|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527970|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527971|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527972|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527973|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527974|NCT00263757|O2|Outcome|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527975|NCT00263757|O1|Outcome|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527976|NCT00263757|E2|Reported Event|Usual Care|Subjects randomized to this arm received medical management for 12 months as prescribed by their cardiologist.
527977|NCT00263757|E1|Reported Event|Therapeutic Positive Airway Pressure|Subjects randomized to this arm received nightly Adaptive Servo-Ventilation during sleep for 12 months.
527978|NCT00263666|B3|Baseline|Total|Total of all reporting groups
527979|NCT00263666|B2|Baseline|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527980|NCT00263666|B1|Baseline|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527981|NCT00263666|P2|Participant Flow|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527982|NCT00263666|P1|Participant Flow|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527983|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527984|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527985|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527986|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527987|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527988|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527989|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527990|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527991|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527992|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527993|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527994|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527995|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527996|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527997|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527998|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
527999|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528000|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528001|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528002|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528003|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528004|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528005|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528006|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528007|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528008|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528009|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528010|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528011|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528012|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528013|NCT00263666|O1|Outcome|Rotarix Group 1|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528014|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528015|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528016|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528017|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528018|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528019|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528020|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528021|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528022|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528023|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528024|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528025|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528026|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528027|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528028|NCT00263666|O2|Outcome|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528029|NCT00263666|O1|Outcome|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528030|NCT00263666|E2|Reported Event|Placebo Group|Subjects received 3 doses of placebo co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528031|NCT00263666|E1|Reported Event|Rotarix Group|Subjects received 3 doses of Rotarix vaccine co-administered with routine Tritanrix™ HepB Hib and Polio Sabin™ vaccines.
528032|NCT00263328|B4|Baseline|Total|Total of all reporting groups
528033|NCT00263328|B3|Baseline|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528034|NCT00263328|B2|Baseline|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528035|NCT00263328|B1|Baseline|Tofacitinib|Participants received tacrolimus BID, administered according to standard institutional practice. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528036|NCT00263328|P3|Participant Flow|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528037|NCT00263328|P2|Participant Flow|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528038|NCT00263328|P1|Participant Flow|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months posttransplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
528039|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528040|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528041|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528262|NCT00262847|P1|Participant Flow|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528353|NCT00262522|B1|Baseline|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
530632|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
528042|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528043|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528044|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528045|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528046|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528047|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528048|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528049|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528050|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528051|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528052|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528053|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528054|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528055|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528056|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528057|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528058|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528059|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528060|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528061|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528592|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
528062|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator’s discretion.
528063|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528064|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528065|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528066|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528067|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528068|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528069|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528070|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528263|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528264|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528071|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528072|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528073|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528074|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528075|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528076|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528077|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528078|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528079|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528080|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528593|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528081|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528082|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528083|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528084|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528085|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528086|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528087|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528088|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528089|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528090|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528091|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528092|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528093|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528094|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528095|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528096|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528097|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528098|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528099|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528118|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528100|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528101|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528102|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528103|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528104|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528105|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528106|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528107|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528108|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528228|NCT00262951|B1|Baseline|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
528354|NCT00262522|P4|Participant Flow|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
528109|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528110|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528111|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528112|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528113|NCT00263328|O2|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528114|NCT00263328|O1|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528115|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528116|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528117|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528265|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528266|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528119|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528120|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528121|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528122|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528123|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528124|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528125|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528126|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528127|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528229|NCT00262951|P1|Participant Flow|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
528300|NCT00262639|B5|Baseline|Total|Total of all reporting groups
528301|NCT00262639|B4|Baseline|High CIWAar Flumazenil/Gabapentin|
528128|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528129|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528130|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528131|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528132|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528133|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528134|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528135|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528136|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528230|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
528302|NCT00262639|B3|Baseline|High CIWAar Placebo|
528303|NCT00262639|B2|Baseline|Low CIWAar Flumazenil/Gabapentin|
528137|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528138|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528139|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528140|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528141|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528142|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528143|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528144|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528145|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528231|NCT00262951|O1|Outcome|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients will be given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday -Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
528304|NCT00262639|B1|Baseline|Low CIWAar Placebo|
528355|NCT00262522|P3|Participant Flow|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528146|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528147|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528148|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528149|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528150|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528151|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528152|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528153|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528154|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528232|NCT00262951|E1|Reported Event|Pancreatic Adenocarcinoma Patients|Pancreatic Adenocarcinoma Patients treated with chemotherapy regimen and radiation (and or surgery). Patients were given one cycle of continuous infusion 5-FU (175 mg/m^2/day for 38 days), weekly cisplatin 30 mg/m^2 over 1 hour, and IFN-alpha-2b (3 million units given subcutaneously on days 1, 3, and 5 of each week for 5½ weeks) with radiation therapy (5040 cGy total, in 28 fractions, at 180 cGy/fraction daily, Monday –Friday, for 5½ weeks) followed by two cycles of bolus 5-FU alone (500 mg/m^2 weekly * 6, followed by 2 weeks of rest).
528345|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
530713|NCT00255008|E2|Reported Event|Genotype 1 Caucasian PEG-IFN/RIB 48w|
528155|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528156|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528157|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528158|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528159|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528160|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528161|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528162|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528163|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528233|NCT00262925|B1|Baseline|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
528346|NCT00262600|E3|Reported Event|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528347|NCT00262600|E2|Reported Event|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528164|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528165|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528166|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528167|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528168|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528169|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528170|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528171|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528172|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528234|NCT00262925|P1|Participant Flow|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM ; oral dexamethasone ; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
528348|NCT00262600|E1|Reported Event|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528349|NCT00262522|B5|Baseline|Total|Total of all reporting groups
528173|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528174|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528175|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528176|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528177|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528178|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528179|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528180|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528181|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528258|NCT00262847|B2|Baseline|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528259|NCT00262847|B1|Baseline|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528350|NCT00262522|B4|Baseline|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
530714|NCT00255008|E1|Reported Event|Genotype 1 SEA PEG-IFN/RIB 48w|
528182|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528183|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528184|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528185|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528186|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528187|NCT00263328|O3|Outcome|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528188|NCT00263328|O2|Outcome|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528189|NCT00263328|O1|Outcome|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528190|NCT00263328|E3|Reported Event|Tofacitinib 30-15-10 mg BID|Participants receiving tofacitinib 30 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) tapered tofacitinib dosage from 30 mg BID to 15 mg BID over 4 weeks on entry into Study A3921021 (25 mg BID for 2 weeks, 20 mg BID for 2 weeks, then 15 mg BID thereafter). Within the window of Months 12-24 post-transplant, tofacitinib dosage was tapered from 15 mg BID to 10 mg BID and participants remained on 10 mg BID throughout the duration of the study, for a maximum of 90 months. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528260|NCT00262847|P3|Participant Flow|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528261|NCT00262847|P2|Participant Flow|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528351|NCT00262522|B3|Baseline|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528191|NCT00263328|E2|Reported Event|Tofacitinib 15-10-5 mg BID|Participants receiving tofacitinib 15 mg, tablets, PO, BID at study entry (rollover from Parent Study A3921009) reduced the dose of tofacitinib to 10 mg BID on entry into Study A3921021. Within the window of Months 12-24 post-transplant, tofacitinib dosage was then tapered from 10 mg BID to 5 mg BID over 4 weeks (5 mg in the morning and 10 mg in the evening for 4 weeks, then 5 mg BID thereafter) and the participant remained on 5 mg BID throughout the duration of the study, for a maximum of 90 months. In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528192|NCT00263328|E1|Reported Event|Tacrolimus|Participants received tacrolimus BID, administered according to standard institutional practice up to 72 months. Tacrolimus dosage was adjusted to achieve pre-determined target predose (trough) tacrolimus levels in whole blood (5-12 ng/mL through 12 months post-transplant, 3-10 ng/mL thereafter). In addition, African-American participants may have received MMF, up to 3 gm per day through Month 6 post-transplant. Participants also received corticosteroids (prednisone ≤5 mg daily [or equivalent] through at least 12 months post-transplant. Thereafter, steroids may have been discontinued at the investigator's discretion.
528193|NCT00262964|B3|Baseline|Total|Total of all reporting groups
528194|NCT00262964|B2|Baseline|NAFLD|Subjects diagnosed with Non-Alcoholic Fatty Liver Disease(NAFLD). Determination of NAFLD was by magnetic resonance spectroscopy of intra-hepatic triglyceride content (defined by greater than 10% lipid to water signal). This group included subjects later randomized into the NAFLD-Niacin, NAFLD-Fenofibrate, and NAFLD-no intervention arms.
528195|NCT00262964|B1|Baseline|Controls|Subjects with normal intra-hepatic triglyceride content (defined by less than 10% lipid to water signal in magnetic resonance spectroscopy).
528196|NCT00262964|P4|Participant Flow|NAFLD - no Drug|Subjects with elevated intrahepatic triglyceride (IHTG) levels (>10%) who were measured only once (baseline). These subjects did not undergo drug therapy, in contrast to the NAFLD-niacin and NAFLD-fenofibrate group subjects. IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
528197|NCT00262964|P3|Participant Flow|Controls|Subjects with normal intrahepatic fat triglyceride(IHTG) levels (<10%). IHTG was measured using magnetic resonance spectroscopy and defined as the extrapolated ratio of triglyceride signal to water signal at time t = 0.
528198|NCT00262964|P2|Participant Flow|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528199|NCT00262964|P1|Participant Flow|NAFLD - Niacin|subjects diagnosed with NAFLD were randomized to a sixteen week regimen of niacin.
528200|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin.
528201|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with elevated intrahepatic triglyceride given an eight week course of fenofibrate
528202|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
528203|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528204|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
528205|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528206|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
528207|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528208|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride (>10% signal by MR spectroscopy) given a 16 week course of niacin
528209|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy receiving fenofibrate for eight weeks.
528210|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects with elevated levels of intra-hepatic trigleceride given a 16 week course of niacin
528211|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy given an eight week course of fenofibrate
528212|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given Niacin for 16 weeks
528213|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528214|NCT00262964|O2|Outcome|NAFLD - Niacin|subjects given niacin for 16 weeks
528215|NCT00262964|O1|Outcome|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an eight week regimen of fenofibrate
528216|NCT00262964|O2|Outcome|Controls|subjects with normal intrahepatic triglyceride levels
528217|NCT00262964|O1|Outcome|NAFLD|Subjects with elevated intrahepatic triglyceride (>10% signal compared to H2O) measured by MR Spectroscopy.
528218|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
528219|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride signal greater than 10% per MR spectroscopy
528220|NCT00262964|O2|Outcome|Controls|subjects with normal levels of intra-hepatic trigleceride
528221|NCT00262964|O1|Outcome|NAFLD|Subjects with intrahepatic triglyceride content greater than 10% per Magnetic Resonance Spectroscopy
528222|NCT00262964|O2|Outcome|Controls|subjects with normal intra-hepatic triglyceride levels
528223|NCT00262964|O1|Outcome|NAFLD|subjects with intra-hepatic triglyceride content greater than 10%.
528224|NCT00262964|E4|Reported Event|Controls|subjects with normal hepatic triglyceride.
528225|NCT00262964|E3|Reported Event|NAFLD - no Drug|subjects with elevated hepatic triglyceride who did not receive any drug intervention
528226|NCT00262964|E2|Reported Event|NAFLD - Niacin|subjects with intra-hepatic triglyceride signal greater than 10% placed on daily niacin for 16 weeks. The dose of medication will be gradually increased according to the protocol of most clinical trials (59): 500 mg/day during wk 1, 1000 mg/day during wk 2, 1500 mg/day during wks 3, and 2000mg/day during wks 4-16.
528227|NCT00262964|E1|Reported Event|NAFLD - Fenofibrate|Subjects diagnosed with NAFLD were randomized to an weight week regimen of fenofibrate
528352|NCT00262522|B2|Baseline|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
530715|NCT00254995|B3|Baseline|Total|Total of all reporting groups
528235|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"Detailed Description Section~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone.~alemtuzumab: Given subcutaneously~asparaginase: Given IM~methotrexate: Given IV or orally~dexamethasone: Given orally~leucovorin calcium: Given IV~mercaptopurine tablet: Given orally~vincristine sulfate: Given IV~laboratory biomarker analysis: Correlative studies"
528236|NCT00262925|O1|Outcome|Treatment (Chemotherapy, Enzyme Inhibitor Therapy)|"INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC on days 1, 4, and 7.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
528237|NCT00262925|E2|Reported Event|MOAD+Campath-Step 2|"Campath 10 mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
528238|NCT00262925|E1|Reported Event|MOAD+Campath-Step 1|"Campath 5mg dose~INDUCTION THERAPY: Patients receive methotrexate IV; vincristine IV and asparaginase IM; oral dexamethasone; and alemtuzumab SC.~CONSOLIDATION THERAPY: Patients receive methotrexate IV and asparaginase IM.~CYTOREDUCTION THERAPY: Patients receive vincristine IV and oral methotrexate IV; leucovorin calcium IV; and oral dexamethasone.~MAINTENANCE THERAPY: Patients receive oral mercaptopurine; oral methotrexate; vincristine IV; and oral dexamethasone."
528239|NCT00262873|B1|Baseline|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528240|NCT00262873|P1|Participant Flow|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528241|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528242|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528243|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528244|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528245|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528246|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528247|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528248|NCT00262873|O1|Outcome|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528249|NCT00262873|E1|Reported Event|Bortezomib|Bortezomib was given at a dose of 1.3 mg per meter squared on day 1, 4, 8, and 11 on a 21 day cycle. Up to 12 cycles were allowed. Response assessments were made after the 3rd, 6th and 12 cycles of therapy.
528250|NCT00262860|B1|Baseline|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528251|NCT00262860|P1|Participant Flow|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528252|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528253|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528254|NCT00262860|O1|Outcome|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528255|NCT00262860|E1|Reported Event|Bortezomib, Gemcitabine Hydrochloride|"bortezomib~gemcitabine hydrochloride~Bortezomib was administered at a dose of 1 mg/m2 on days 1, 4, 8,and 11 of a 21-day schedule. Gemcitabine was administered at a dose of 800 mg/m2 on days 1 and 8 of the same 21-day schedule."
528256|NCT00262847|B4|Baseline|Total|Total of all reporting groups
528257|NCT00262847|B3|Baseline|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528267|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528268|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528269|NCT00262847|O3|Outcome|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528270|NCT00262847|O2|Outcome|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528271|NCT00262847|O1|Outcome|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528272|NCT00262847|E3|Reported Event|Arm III (Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-throughout therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received bevacizumab, 15 mg/kg every 3 weeks."
528273|NCT00262847|E2|Reported Event|Arm II (Placebo, Paclitaxel, Carboplatin, Bevacizumab)|"Bevacizumab-initiation therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus bevacizumab, 15 mg/kg (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528274|NCT00262847|E1|Reported Event|Arm I (Placebo, Paclitaxel, Carboplatin)|"Control therapy:~Cycles 1-6 received paclitaxel, 175 mg/m2 plus carboplatin AUC 6 plus placebo (starting in cycle 2) every 3 weeks.~Cycles 7-22 received placebo every 3 weeks."
528275|NCT00262834|B3|Baseline|Total|Total of all reporting groups
528276|NCT00262834|B2|Baseline|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
528277|NCT00262834|B1|Baseline|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528278|NCT00262834|P2|Participant Flow|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
528279|NCT00262834|P1|Participant Flow|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528280|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
528281|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528282|NCT00262834|O2|Outcome|Tissue Only|Women who declined vorinostat but agreed to donate tissues for biomarker assessment, signed a separate informed consent and were enrolled as controls.
528283|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528284|NCT00262834|O1|Outcome|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528285|NCT00262834|E1|Reported Event|Vorinostat|Women in the vorinostat group were scheduled to receive 6 doses of oral vorinostat at 300 mg twice daily (bid), with the last dose administered by study personnel approximately 2 hours before the scheduled breast surgery (or biopsy).
528286|NCT00262743|B3|Baseline|Total|Total of all reporting groups
528287|NCT00262743|B2|Baseline|Phase II Polyphenon E|2000mg twice daily for 6 months
528288|NCT00262743|B1|Baseline|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice daily for 6 months
528289|NCT00262743|P2|Participant Flow|Phase II Polyphenon E|2000mg orally twice daily for 6 months
528290|NCT00262743|P1|Participant Flow|Phase I Polyphenon E|Dose ranging from 400 to 1,800 mg orally twice a day for 6 months
528291|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
528292|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
528293|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
528294|NCT00262743|O1|Outcome|Phase II Polyphenon E|2000mg twice daily for 6 months
528295|NCT00262743|E1|Reported Event|Phase II Polyphenon E|2000mg orally twice daily for 6 months
528296|NCT00262730|B1|Baseline|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
528297|NCT00262730|P1|Participant Flow|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
528298|NCT00262730|O1|Outcome|Treatment Arm - All Subjects|"poly ICLC, temozolomide, radiation: radiation therapy~poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles)~temozolomide : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant)~radiation therapy : RT: 60 Gy (6 weeks) concomitant therapy"
528299|NCT00262730|E1|Reported Event|Treatment Arm All Subjects|"poly ICLC, TMZ, RT: poly ICLC : 20 mcg/kg 3x each week (Maintenance cycles) TMX : daily 75mg/m2 6wks concomitant therapy Wk 1 - days 1-5 150-200 mg/m2 maintenance cycles (adjuvant) RT : RT: 60 Gy (6 weeks) concomitant therapy~AEs Grades 4 with Attributions of Possible, probably or definitely related to TMZ AND poly-ICLI"
528305|NCT00262639|P4|Participant Flow|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528306|NCT00262639|P3|Participant Flow|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528307|NCT00262639|P2|Participant Flow|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528308|NCT00262639|P1|Participant Flow|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528309|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528310|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528311|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528312|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528313|NCT00262639|O4|Outcome|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528314|NCT00262639|O3|Outcome|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528315|NCT00262639|O2|Outcome|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528316|NCT00262639|O1|Outcome|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528317|NCT00262639|E4|Reported Event|High CIWAar Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528318|NCT00262639|E3|Reported Event|High CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528319|NCT00262639|E2|Reported Event|Low CIWAar Placebo|20 mg Saline infused slowly over 20 minutes. Placebo 1 capsule Day 1, 2 capsules Day 2, 3 capsules Day 3, 4 capsules days 4 to 30; 3 capsules Day 31 to 33; 2 capsules day 34 to 36 and 1 capsule 37 to 39.
528320|NCT00262639|E1|Reported Event|Low CIWA Flumazenil/Gabapentin|2 mg flumazenil given over 20 minutes on Day 1 and Day 2. Gabapentin 300 mg Day 1; gabapentin 600 mg Day 2; gabapentin 900 mg Day 3; gabapentin 1200 mg Day 4 to 30; gabapentin 900 mg day 31-33; gabapentin 600 mg day 34-36; gabapentin 300 mg day 37-39.
528321|NCT00262600|B4|Baseline|Total|Total of all reporting groups
528322|NCT00262600|B3|Baseline|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528323|NCT00262600|B2|Baseline|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528324|NCT00262600|B1|Baseline|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528325|NCT00262600|P3|Participant Flow|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528326|NCT00262600|P2|Participant Flow|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528327|NCT00262600|P1|Participant Flow|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528328|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528329|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528330|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528331|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528332|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528333|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528334|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528335|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528336|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528337|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528338|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528339|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528340|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528341|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528342|NCT00262600|O1|Outcome|Dabigatran 110 mg|110 mg twice daily, total daily dose 220 mg
528343|NCT00262600|O3|Outcome|Warfarin|Target International Normalized Ratio (INR) of 2.0 to 3.0
528344|NCT00262600|O2|Outcome|Dabigatran 150 mg|150 mg twice daily, total daily dose 300 mg
528356|NCT00262522|P2|Participant Flow|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
528357|NCT00262522|P1|Participant Flow|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528358|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
528359|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528360|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
528361|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528362|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
528363|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528364|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
528365|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528366|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
528367|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528368|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
528369|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528370|NCT00262522|O4|Outcome|LPV/r 400/100 mg BID SGC (Through Week 8)|lopinavir/ritonavir 400/100 mg twice daily (BID) soft gel capsule (SGC)
528371|NCT00262522|O3|Outcome|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528372|NCT00262522|O2|Outcome|LPV/r 800/200 mg QD SGC (Through Week 8)|lopinavir/ritonavir 800/200 mg once daily (QD) soft gel capsule (SGC)
528373|NCT00262522|O1|Outcome|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528374|NCT00262522|E2|Reported Event|LPV/r 400/100 mg BID Tablet|lopinavir/ritonavir 400/100 mg twice daily (BID) tablet
528375|NCT00262522|E1|Reported Event|LPV/r 800/200 mg QD Tablet|lopinavir/ritonavir 800/200 mg once daily (QD) tablet
528376|NCT00262509|B3|Baseline|Total|Total of all reporting groups
528377|NCT00262509|B2|Baseline|First Intervention, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes."
528378|NCT00262509|B1|Baseline|First Baseline, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial takes at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial takes at most 15 minutes."
528379|NCT00262509|P2|Participant Flow|Intervention First, Then Baseline|"Intervention First: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Baseline Next: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes."
528380|NCT00262509|P1|Participant Flow|Baseline First, Then Intervention|"Baseline First: For two separate timed trials Blind Participants are walked into a building to different randomized locations, and then asked to find their way out of the building. Each Trial lasted at most 15 minutes.~Intervention Next: Blind Participants are trained for 15 minutes in the use of the egress badge, then in two separate timed trials are walked into a building to different randomized locations, and are asked to find their way out of the building. Each Trial lasted at most 15 minutes."
528381|NCT00262509|O2|Outcome|Baseline|All Blind Participants, in two separate trials, are walked into a building to a specific location, and then are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is calculated as the average of the trial times.
528382|NCT00262509|O1|Outcome|Intervention|All Blind Participants are trained for 15 minutes in the use of the egress device, then for two separate trials are walked into a building to a specific location, and are asked to find their way out of the building. Their egress performance is timed for each trial. The outcome measure is obtained by averaging the two trial times
528383|NCT00262509|E2|Reported Event|Baseline Egress|Blind subjects are walked into a building to different locations in two separate trials and then asked to find their way out of the building.
528384|NCT00262509|E1|Reported Event|Egress Badge Intervention|Blind Participants are trained for 15 minutes in the use of the egress badge, then for two separate trials they are walked into a building to a different locations, and are asked to find their way out of the building.
528385|NCT00262314|B1|Baseline|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528386|NCT00262314|P1|Participant Flow|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528387|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528388|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528389|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528390|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
530983|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
528391|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528392|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528393|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528394|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528395|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528396|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528397|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528398|NCT00262314|O1|Outcome|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528399|NCT00262314|E1|Reported Event|Novantrone Therapy|Novantrone, 12 mg/m2 intravenously once every 3 months, until a 140 mg/m2 cumulative dose was reached
528400|NCT00262301|B4|Baseline|Total|Total of all reporting groups
528401|NCT00262301|B3|Baseline|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
528402|NCT00262301|B2|Baseline|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
528403|NCT00262301|B1|Baseline|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
528404|NCT00262301|P3|Participant Flow|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received, 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase. Patients received 1 vial initially and could receive an additional 1-2 vials within 4 hours at the investigator's discretion."
528405|NCT00262301|P2|Participant Flow|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
528406|NCT00262301|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
528407|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
528408|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
528409|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
528410|NCT00262301|O3|Outcome|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
528411|NCT00262301|O2|Outcome|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
528412|NCT00262301|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
528413|NCT00262301|E3|Reported Event|"1 Vial (2100 IU) rhC1INH"|"Includes all subjects who received 1 vial (2100 IU) open-label rhC1INH in the open-label extension phase."
528414|NCT00262301|E2|Reported Event|Saline|Includes all subjects randomized and who received Saline solution in the double-blind phase.
528415|NCT00262301|E1|Reported Event|"100 IU/kg rhC1INH"|Includes all subjects randomized who received 100 IU/kg recombinant human C1 inhibitor in the double-blind phase.
528416|NCT00262223|B3|Baseline|Total|Total of all reporting groups
528417|NCT00262223|B2|Baseline|2) Seeking Safety + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill placebo
528418|NCT00262223|B1|Baseline|1) Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
528419|NCT00262223|P2|Participant Flow|2) Seeking Safety + Placebo|"Seeking Safety + Placebo;~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
528420|NCT00262223|P1|Participant Flow|1) Seeking Safety + Sertraline|"Seeking Safety + Sertraline~Seeking Safety: Seeking Safety cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders~Sertraline: An anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type"
528421|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo;
528422|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
528423|NCT00262223|O2|Outcome|2) Seeking Safety + Placebo|Seeking Safety + Placebo
528424|NCT00262223|O1|Outcome|1) Seeking Safety + Sertraline|Seeking Safety + Sertraline
528425|NCT00262223|E2|Reported Event|Seeking Seeking + Placebo|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders + Pill Placebo
528426|NCT00262223|E1|Reported Event|Seeking Safety + Sertraline|Seeking Safety, a cognitive-behavioral treatment intervention for comorbid PTSD and substance use disorders, + Setraline, an anti-depressant medication, selective serotonin reuptake inhibitor (SSRI) type
528427|NCT00262119|B4|Baseline|Total|Total of all reporting groups
528428|NCT00262119|B3|Baseline|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528429|NCT00262119|B2|Baseline|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528430|NCT00262119|B1|Baseline|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528431|NCT00262119|P3|Participant Flow|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528432|NCT00262119|P2|Participant Flow|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
531633|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
528433|NCT00262119|P1|Participant Flow|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528434|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528435|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528436|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528437|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528438|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528439|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528440|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528441|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528442|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528443|NCT00262119|O3|Outcome|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528444|NCT00262119|O2|Outcome|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528445|NCT00262119|O1|Outcome|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528446|NCT00262119|E3|Reported Event|DDDRP|"PM programming according to actual clinical practice + MVP algorithm ON + Atrial fibrillation therapies ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528447|NCT00262119|E2|Reported Event|MVP Only|"PM programming according to actual clinical practice + MVP algorithm ON~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528448|NCT00262119|E1|Reported Event|Control Group|"PM programming according to actual clinical practice~Pacemaker Medtronic EnRhythm: Pacemaker specific programming"
528449|NCT00262080|B4|Baseline|Total|Total of all reporting groups
528450|NCT00262080|B3|Baseline|Ecallantide (Repeat-Dosing Part Only)|"Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.~One patient was omitted from analysis in the intent-to-treat and per-protocol populations due to the loss of the data for the 4-hour post-dose assessments during treatment episode 1."
528451|NCT00262080|B2|Baseline|Placebo / Ecallantide|Patients treated with placebo in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
528452|NCT00262080|B1|Baseline|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part (ITT as treated) and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
528453|NCT00262080|P3|Participant Flow|Ecallantide (Repeat Dose Only)|Patients not treated in the double-blind part but treated with ecallantide in the repeat-dosing part.
528454|NCT00262080|P2|Participant Flow|Placebo / Ecallantide|Patients treated with placebo in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
528455|NCT00262080|P1|Participant Flow|Ecallantide / Ecallantide|Patients treated with ecallantide in the double-blind part and eligible for treatment with ecallantide in the repeat-dosing part of the study once their Follow-up Visit 1 (Day 7) in the double-blind part was completed.
528456|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
528457|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
528458|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
528459|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
528460|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the repeat-dose part.
528461|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
528462|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
528463|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
528464|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
528465|NCT00262080|O2|Outcome|Placebo|Patients treated with placebo in the double-blind part.
528466|NCT00262080|O1|Outcome|Ecallantide|Patients treated with ecallantide in the double-blind part.
528467|NCT00262080|E3|Reported Event|Repeat-Dosing Ecallantide|All patients treated with ecallantide in the repeat-dosing part, regardless of whether they were treated previously in the double-blind part or not. All adverse events reported in all repeat-dosing episodes are included. Patients reporting more than 1 AE with the same preferred term are counted only once for that preferred term.
528468|NCT00262080|E2|Reported Event|Double-Blind Placebo|Patients treated with placebo in the double-blind part only.
528469|NCT00262080|E1|Reported Event|Double Blind - Ecallantide|Patients treated with ecallantide in the double-blind part only.
528470|NCT00262067|B5|Baseline|Total|Total of all reporting groups
528471|NCT00262067|B4|Baseline|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528472|NCT00262067|B3|Baseline|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
531634|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
528473|NCT00262067|B2|Baseline|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528474|NCT00262067|B1|Baseline|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528475|NCT00262067|P4|Participant Flow|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528476|NCT00262067|P3|Participant Flow|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528477|NCT00262067|P2|Participant Flow|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528478|NCT00262067|P1|Participant Flow|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528479|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528480|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528481|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528482|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528483|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528484|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528485|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528486|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528487|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528488|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528489|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528490|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528491|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528492|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528493|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528494|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528495|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528496|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528497|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528498|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528499|NCT00262067|O4|Outcome|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528500|NCT00262067|O3|Outcome|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528591|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM vaccine
528501|NCT00262067|O2|Outcome|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528502|NCT00262067|O1|Outcome|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528503|NCT00262067|E4|Reported Event|Placebo to Bevacizumab + Capecitabine|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528504|NCT00262067|E3|Reported Event|Bevacizumab 15 mg/kg + Capecitabine|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + capecitabine standard chemotherapy for metastatic breast cancer.
528505|NCT00262067|E2|Reported Event|Placebo to Bevacizumab + Taxane or Anthracycline-based Regimen|Patients received placebo to bevacizumab administered IV on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528506|NCT00262067|E1|Reported Event|Bevacizumab 15 mg/kg + Taxane or Anthracycline-based Regimen|Patients received bevacizumab 15 mg/kg intravenously (IV) on Day 1 of every 21-day cycle + either a taxane or anthracycline-based standard chemotherapy for metastatic breast cancer.
528507|NCT00262041|B5|Baseline|Total|Total of all reporting groups
528508|NCT00262041|B4|Baseline|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
528509|NCT00262041|B3|Baseline|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
528510|NCT00262041|B2|Baseline|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528511|NCT00262041|B1|Baseline|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528512|NCT00262041|P3|Participant Flow|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
528513|NCT00262041|P2|Participant Flow|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528514|NCT00262041|P1|Participant Flow|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528515|NCT00262041|O4|Outcome|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2)
528516|NCT00262041|O3|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528517|NCT00262041|O2|Outcome|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1)
528518|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528519|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
528520|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528521|NCT00262041|O2|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
528522|NCT00262041|O1|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528523|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
528524|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528525|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528526|NCT00262041|O3|Outcome|MenACWY-PS|Subjects received one single dose of the MenACWY polysaccharide vaccine.
528527|NCT00262041|O2|Outcome|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528528|NCT00262041|O1|Outcome|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528529|NCT00262041|E4|Reported Event|MenACWY-PS -Stage 2|Subjects received a single dose of MenACWY polysaccharide vaccine (Stage 2 - 4:1 MenACWY-CRM:MenACWY-PS randomization scheme).
528530|NCT00262041|E3|Reported Event|MenACWY-PS - Stage 1|Subjects received a single of MenACWY polysaccharide vaccine on day 1 (Stage 1 - 1:1 randomization scheme).
528531|NCT00262041|E2|Reported Event|MenACWY-CRM(Ad-)|Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.
528532|NCT00262041|E1|Reported Event|MenACWY-CRM(Ad+)|Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
528533|NCT00262028|B10|Baseline|Total|Total of all reporting groups
528534|NCT00262028|B9|Baseline|MenACWY+PS (3-5 YearsOld)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
528535|NCT00262028|B8|Baseline|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
528536|NCT00262028|B7|Baseline|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528537|NCT00262028|B6|Baseline|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
528538|NCT00262028|B5|Baseline|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528539|NCT00262028|B4|Baseline|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
528540|NCT00262028|B3|Baseline|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528541|NCT00262028|B2|Baseline|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
528542|NCT00262028|B1|Baseline|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528543|NCT00262028|P9|Participant Flow|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY- polysaccharide (PS) vaccine from the first part of the study (Menomune, not licensed in US in children under 2 years of age) were used as controls for the 12-23-months-old part two toddlers.
531635|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
528544|NCT00262028|P8|Participant Flow|MenACWY+DTaP (16-23 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with diphtheria-tetanus-acellular pertussis (DTaP) vaccine.
528545|NCT00262028|P7|Participant Flow|MenACWY (16-23 Months)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528546|NCT00262028|P6|Participant Flow|MenACWY+PnC (12-15 Months)|Subjects received one dose of the MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine (PnC).
528547|NCT00262028|P5|Participant Flow|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528548|NCT00262028|P4|Participant Flow|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
528549|NCT00262028|P3|Participant Flow|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528550|NCT00262028|P2|Participant Flow|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
528551|NCT00262028|P1|Participant Flow|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-cross-reactive material (CRM) conjugate vaccine.
528552|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with DTaP
528553|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528554|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine in concomitant with PnC
528555|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528556|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
528557|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528558|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
528559|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528560|NCT00262028|O4|Outcome|MenACWY-CRM + DTaP (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with DTaP
528561|NCT00262028|O3|Outcome|MenACWY-CRM (16-23 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528562|NCT00262028|O2|Outcome|MenACWY-CRM + PnC (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine concomitantly with PnC
528563|NCT00262028|O1|Outcome|MenACWY-CRM (12-15 Months)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528564|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
528565|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528566|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
528567|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of investigational MenACWY-CRM conjugate vaccine
528568|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
528569|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528570|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
528571|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528572|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine
528573|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528574|NCT00262028|O6|Outcome|MenACWY-PS (6-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
528575|NCT00262028|O5|Outcome|MenACWY-CRM (6-10 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528576|NCT00262028|O4|Outcome|MenACWY-PS (2-5 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
528577|NCT00262028|O3|Outcome|MenACWY-CRM (2-5 Years)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528578|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
528579|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528580|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine This group was a subset of the Licensed comparator (2-5 year old) cohort that received one dose of licensed MenACWY-PS vaccine.
528581|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528582|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of MenACWY-PS vaccine
528583|NCT00262028|O3|Outcome|MenACWY-CRM (6-10 Years Old)|Subjects received one dose of MenACWY-CRM conjugate vaccine
528584|NCT00262028|O2|Outcome|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the MenACWY-PS vaccine
528585|NCT00262028|O1|Outcome|MenACWY-CRM (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528586|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
528587|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528588|NCT00262028|O2|Outcome|MenACWY-PS (3-5 Years Old)|Subjects received one dose of the licensed MenACWY-PS vaccine. This group was a subset of the licensed comparator (2-5 years old) cohort that received one dose of licensed MenACWY-PS vaccine
528589|NCT00262028|O1|Outcome|MenACWY-CRM (12-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528590|NCT00262028|O4|Outcome|MenACWY-PS (6-10 Years Old)|Subjects received one dose of licensed MenACWY-PS vaccine
530984|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
528594|NCT00262028|O2|Outcome|MenACWY-PS (2-10 Years)|Subjects received one dose of the licensed MenACWY-PS vaccine
528595|NCT00262028|O1|Outcome|MenACWY-CRM (2-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine
528596|NCT00262028|E9|Reported Event|MenACWY-PS (3-5 Years Old)|Children aged 3 to 5 years receiving MenACWY-PS from the first part of the study (Menomune not licensed in US in children under 2 years of ages) served as controls for the 12-23-months-old part two toddlers.
528597|NCT00262028|E8|Reported Event|MenACWY+DTaP (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with DTaP vaccine.
528598|NCT00262028|E7|Reported Event|MenACWY (16-23 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528599|NCT00262028|E6|Reported Event|MenACWY-PnC (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine administered concomitantly with pneumococcal conjugate vaccine.
528600|NCT00262028|E5|Reported Event|MenACWY (12-15 Months Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528601|NCT00262028|E4|Reported Event|MenACWY-PS (6-10 Years Old)|Subjects received one dose of the licensed MenACWY-CRM polysaccharide vaccine.
528602|NCT00262028|E3|Reported Event|MenACWY (6-10 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528603|NCT00262028|E2|Reported Event|MenACWY-PS (2-5 Years Old)|Subjects received one dose of the licensed MenACWY-polysaccharide vaccine.
528604|NCT00262028|E1|Reported Event|MenACWY (2-5 Years Old)|Subjects received one dose of the investigational MenACWY-CRM conjugate vaccine.
528605|NCT00262002|B8|Baseline|Total|Total of all reporting groups
528606|NCT00262002|B7|Baseline|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528607|NCT00262002|B6|Baseline|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528608|NCT00262002|B5|Baseline|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528609|NCT00262002|B4|Baseline|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528610|NCT00262002|B3|Baseline|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528611|NCT00262002|B2|Baseline|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528612|NCT00262002|B1|Baseline|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528613|NCT00262002|P7|Participant Flow|CA24- (MenACWY Ad- at 2,4m)|"Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528614|NCT00262002|P6|Participant Flow|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528615|NCT00262002|P5|Participant Flow|CA24+ (MenACWY Ad+ at 2,4m)|"Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528616|NCT00262002|P4|Participant Flow|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528617|NCT00262002|P3|Participant Flow|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528618|NCT00262002|P2|Participant Flow|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528619|NCT00262002|P1|Participant Flow|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528620|NCT00262002|O10|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528621|NCT00262002|O9|Outcome|CA24- (MenACWY Ad- at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528999|NCT00261833|E1|Reported Event|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528622|NCT00262002|O8|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528623|NCT00262002|O7|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528624|NCT00262002|O6|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m) - ACWY|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528625|NCT00262002|O5|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - PS|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528626|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m) - No Treatment|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528627|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528628|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528629|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528630|NCT00262002|O7|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528631|NCT00262002|O6|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528632|NCT00262002|O5|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528633|NCT00262002|O4|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528634|NCT00262002|O3|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528635|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528636|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528637|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528638|NCT00262002|O4|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528639|NCT00262002|O3|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528640|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528641|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528642|NCT00262002|O6|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528643|NCT00262002|O5|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
529000|NCT00261716|B3|Baseline|Total|Total of all reporting groups
528644|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528645|NCT00262002|O3|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528646|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528647|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528648|NCT00262002|O6|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528649|NCT00262002|O5|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528650|NCT00262002|O4|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528651|NCT00262002|O3|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528652|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528653|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528654|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528655|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528656|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528657|NCT00262002|O3|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528658|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528659|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528660|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528661|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528662|NCT00262002|O2|Outcome|CA24- (MenACWY Ad- at 2, 4m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528663|NCT00262002|O1|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528664|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2, 4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528665|NCT00262002|O1|Outcome|CA246+ (MenACWY Ad+ at 2,4,6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528666|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528667|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528668|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528669|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age
528670|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528671|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528672|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528673|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528674|NCT00262002|O1|Outcome|UKMenC (Menjugate at 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528675|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528676|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose ( of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528677|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528678|NCT00262002|O2|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528679|NCT00262002|O1|Outcome|UKMenC (Menjugate 2, 4 m)|Two doses of Menjugate were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was given at 12 months of age.
528680|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|"Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528681|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528682|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528683|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528684|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
530985|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
528685|NCT00262002|O5|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528686|NCT00262002|O4|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528687|NCT00262002|O3|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528688|NCT00262002|O2|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528689|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528690|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528691|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528692|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine or one reduced dose of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528693|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528694|NCT00262002|O4|Outcome|CA24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age. One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528695|NCT00262002|O3|Outcome|UK24- (MenACWY Ad- at 2, 4 m)|Two doses of MenACWY conjugate vaccine without adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was given at 12 months of age.
528696|NCT00262002|O2|Outcome|CA24+ (MenACWY Ad+ at 2, 4 m)|"Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.~One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was given concomitantly with MMR (and Prevnar, if available) at 12 months of age."
528697|NCT00262002|O1|Outcome|UK24+ (MenACWY Ad+ at 2, 4 m)|Two doses of MenACWY conjugate vaccine with adjuvant were given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was given at 12 months of age.
528698|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528699|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528700|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528701|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528702|NCT00262002|O2|Outcome|CA246+ (MenACWY Ad+ at 2, 4, 6 m)|Three doses of MenACWY conjugate vaccine with adjuvant were given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528703|NCT00262002|O1|Outcome|UK234+ (MenACWY Ad+ at 2, 3, 4 m)|Three doses of MenACWY conjugate vaccine with adjuvant vaccine were given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was given at 12 months of age.
528704|NCT00262002|E7|Reported Event|CA24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2 and 4 months of age.One dose of MenACWY Ad- vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528705|NCT00262002|E6|Reported Event|UK24- (MenACWY Ad- at 2,4m)|Two doses of MenACWY Ad- vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad- vaccine was to be given at 12 months of age.
529623|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
528706|NCT00262002|E5|Reported Event|CA24+ (MenACWY Ad+ at 2,4m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV, HBV, and Prevnar at 2 and 4 months of age.One dose of MenACWY Ad+ vaccine or one reduced dose (one fifth) of MenACWY PS vaccine was to be given concomitantly with MMR (and Prevnar, if available) at 12 months of age.
528707|NCT00262002|E4|Reported Event|CA246+ (MenACWY Ad+ at 2,4,6m)|Three doses of MenACWY Ad+ vaccine were to be given at 2-month intervals concomitantly with DTaPHibIPV, HBV, and Prevnar® at 2, 4, and 6 months of age (Prevnar at 6 months was optional and was given if available). One subgroup of subjects was to be given a reduced dose of MenACWY PS vaccine concomitantly with MMR (and Prevnar, if available) at 12 months of age. Another subgroup was to be administered one dose of MMR (and Prevnar, if available) at 12 months of age.
528708|NCT00262002|E3|Reported Event|UKMenC (Menjugate at 2,4m)|Two doses of Menjugate® were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. One dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
528709|NCT00262002|E2|Reported Event|UK24+ (MenACWY Ad+ at 2,4 m)|Two doses of MenACWY Ad+ vaccine were to be given at a 2-month interval concomitantly with DTaPHibIPV at 2 and 4 months of age. A third dose of MenACWY Ad+ vaccine was to be given at 12 months of age.
528710|NCT00262002|E1|Reported Event|UK234+ (MenACWY Ad+ at 2,3,4 m)|Three doses of MenACWY Ad+ vaccine were to be given at 1-month intervals concomitantly with DTaPHibIPV at 2, 3, and 4 months of age. A fourth dose of MenACWY Ad+ was to be given at 12 months of age.
528711|NCT00261950|B1|Baseline|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528712|NCT00261950|P1|Participant Flow|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528713|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528714|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528715|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528716|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528717|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528718|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528719|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528720|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528721|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528722|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528723|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528724|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528725|NCT00261950|O1|Outcome|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528726|NCT00261950|E1|Reported Event|Cinacalcet|cinacalcet hydrochloride. Participants received a starting dose of 30 mg cinacalcet daily (QD). Dose adjustments were based upon repeated measurements of intact parathyroid hormone, calcium serum concentrations, and participant safety information.
528727|NCT00261846|B12|Baseline|Total|Total of all reporting groups
528728|NCT00261846|B11|Baseline|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528729|NCT00261846|B10|Baseline|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
529624|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
528730|NCT00261846|B9|Baseline|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528731|NCT00261846|B8|Baseline|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528732|NCT00261846|B7|Baseline|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528733|NCT00261846|B6|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528734|NCT00261846|B5|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528735|NCT00261846|B4|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528736|NCT00261846|B3|Baseline|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528737|NCT00261846|B2|Baseline|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528738|NCT00261846|B1|Baseline|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528739|NCT00261846|P14|Participant Flow|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528740|NCT00261846|P13|Participant Flow|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528741|NCT00261846|P12|Participant Flow|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528742|NCT00261846|P11|Participant Flow|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528743|NCT00261846|P10|Participant Flow|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528744|NCT00261846|P9|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528745|NCT00261846|P8|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528746|NCT00261846|P7|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528747|NCT00261846|P6|Participant Flow|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528748|NCT00261846|P5|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
531636|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
528749|NCT00261846|P4|Participant Flow|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528750|NCT00261846|P3|Participant Flow|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. Eleven participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528751|NCT00261846|P2|Participant Flow|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528752|NCT00261846|P1|Participant Flow|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528753|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL)
528754|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I).
528755|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I).
528756|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML).
528757|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML).
528758|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML).
528759|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML).
528760|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM.
528761|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM.
528762|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528763|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528764|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528765|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528766|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528767|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528768|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528863|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528769|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528770|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528771|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528772|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528773|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528774|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528775|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528776|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528777|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528778|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528779|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528780|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528781|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528782|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528783|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528784|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528785|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528786|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528990|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528991|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528787|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528788|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528789|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528790|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528791|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528792|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528793|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528794|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528795|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528796|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528797|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528798|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528799|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528800|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528801|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528802|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528803|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528804|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528992|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528993|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528805|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528806|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528807|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528808|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528809|NCT00261846|O9|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528810|NCT00261846|O8|Outcome|BP-CML Total|All participants who received bosutinib 500 mg orally once daily in blast phase (BP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528811|NCT00261846|O7|Outcome|AP-CML Total|All participants who received bosutinib 500 mg orally once daily in advanced phase (AP) chronic myelogenous leukemia (CML) who were imatinib (IM) resistant/intolerant (R/I) or Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528812|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528813|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528814|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528815|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528816|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528817|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528818|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528819|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528820|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528821|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528822|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528823|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528824|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528825|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528826|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528827|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528828|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528829|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528830|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528831|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528832|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528833|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528834|NCT00261846|O5|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528835|NCT00261846|O4|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528836|NCT00261846|O3|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528837|NCT00261846|O2|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528838|NCT00261846|O1|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528839|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528840|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528841|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528842|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528843|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528994|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528844|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528845|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528846|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528847|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528848|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528849|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528850|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528851|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528852|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528853|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528854|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528855|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528856|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528857|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528858|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528859|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528860|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528861|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528862|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528864|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528865|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528866|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528867|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528868|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528869|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528870|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528871|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528872|NCT00261846|O11|Outcome|Bosutinib 500 mg, Ph+ ALL (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528873|NCT00261846|O10|Outcome|Bosutinib 500 mg, BP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528874|NCT00261846|O9|Outcome|Bosutinib 500 mg, BP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with blast phase (BP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528875|NCT00261846|O8|Outcome|Bosutinib 500 mg, AP-CML Multi-TKI R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) Multi-TKI (multiple tyrosine kinase inhibitor: imatinib, dasatinib and/or nilotinib) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528876|NCT00261846|O7|Outcome|Bosutinib 500 mg, AP-CML IM R/I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with advanced phase (AP) imatinib (IM) resistant/intolerant (R/I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528877|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528878|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528879|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528880|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528881|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528882|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528883|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528884|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528885|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528886|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528887|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528888|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528889|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528890|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528891|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528892|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528893|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528894|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528895|NCT00261846|O6|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528896|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528897|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528898|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528899|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528995|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528996|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528900|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528901|NCT00261846|O5|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I, (D+NI) R/I or NI-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I), dasatinib (D) and nilotinib (NI) resistant/intolerant (R/I) or nilotinib (NI) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528902|NCT00261846|O4|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + NI-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and nilotinib (NI) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528903|NCT00261846|O3|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) intolerant (I) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528904|NCT00261846|O2|Outcome|Bosutinib 500 mg, CP3L-CML IM R/I + D-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase third-line (CP3L) imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R) chronic myelogenous leukemia (CML) until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528905|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-I (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) intolerant (I) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase Src, Abl, or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528906|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528907|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528908|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528909|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528910|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528911|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528912|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528913|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528914|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528915|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528916|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528917|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528918|NCT00261846|O1|Outcome|Bosutinib 500 mg, CP2L-CML IM-R (Part 2)|Bosutinib 500 mg was administered orally once-daily in participants with chronic phase second-line (CP2L) imatinib (IM) resistant/refractory (R) chronic myelogenous leukemia (CML); who had no prior proto-oncogene tyrosine-protein kinase sarcoma (Src), abelson kinase (Abl), or Src-Abl inhibitor exposure other than IM until disease progression, unacceptable toxicity, or withdrawal of consent occurred.
528919|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528920|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528921|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528922|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528923|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528924|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528925|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528926|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528927|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528928|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528929|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528930|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528931|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528932|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528933|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528934|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528997|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528998|NCT00261833|E2|Reported Event|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528935|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528936|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528937|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528938|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528939|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528940|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528941|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528942|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528943|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528944|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528945|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528946|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528947|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528948|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528949|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528950|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528951|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528952|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528953|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528954|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528955|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528956|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528957|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528958|NCT00261846|O1|Outcome|All Treated Participants|All participants who received single oral dose of bosutinib 400 mg, 500 mg or 600 mg on Day 1 and then bosutinib 400 mg, 500 mg or 600 mg orally once daily continuously from Day 3 up to Week 4.
528959|NCT00261846|O3|Outcome|Bosutinib 600 mg (Part 1)|Single oral dose of bosutinib 600 mg on Day 1 and then bosutinib 600 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study. Eleven participants who completed treatment in Part 1 were continued in CP2L-CML Part 2 of the study and 1 participant was continued in advanced phase chronic myelogenous leukemia (AP-CML) Part 2 of the study.
528960|NCT00261846|O2|Outcome|Bosutinib 500 mg (Part 1)|Single oral dose of bosutinib 500 mg on Day 1 and then bosutinib 500 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528961|NCT00261846|O1|Outcome|Bosutinib 400 mg (Part 1)|Single oral dose of bosutinib 400 milligram (mg) on Day 1 and then bosutinib 400 mg orally once daily continuously from Day 3 up to Week 4. All participants who completed treatment in Part 1 were continued in chronic phase second-line chronic myelogenous leukemia (CP2L-CML) Part 2 of the study.
528962|NCT00261846|E3|Reported Event|Advanced Phase|All participants who received bosutinib 500 mg orally once daily for 48 weeks in advanced phase (AP) and blast phase (BP) chronic myelogenous leukemia (CML), and Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL).
528963|NCT00261846|E2|Reported Event|CP3L-CML|All participants who received bosutinib 500 mg orally once daily for 48 weeks in chronic phase third-line (CP3L) chronic myelogenous leukemia (CML), participants were imatinib (IM) resistant/intolerant (R/I) and dasatinib (D) resistant (R), dasatinib (D) intolerant (I), nilotinib (NI) resistant (R), and dasatinib and nilotinib resistant/intolerant (R/I) or nilotinib intolerant (I).
528964|NCT00261846|E1|Reported Event|CP2L-CML|All participants who received bosutinib 500 mg orally once daily for 48 weeks in chronic phase second-line (CP2L) chronic myelogenous leukemia (CML), who were imatinib (IM) resistant/refractory (R) and IM intolerant (I).
528965|NCT00261833|B3|Baseline|Total|Total of all reporting groups
528966|NCT00261833|B2|Baseline|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528967|NCT00261833|B1|Baseline|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528968|NCT00261833|P2|Participant Flow|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528969|NCT00261833|P1|Participant Flow|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528970|NCT00261833|O2|Outcome|Placebo|Placebo: Lyophilized preparation: 60 mg/kg body weight/week intravenous
528971|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528972|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528973|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528974|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528975|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528976|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528977|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528978|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528979|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528980|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528981|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528982|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528983|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528984|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528985|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528986|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528987|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
528988|NCT00261833|O2|Outcome|Placebo|Lyophilized preparation: 60 mg/kg body weight/week intravenous
528989|NCT00261833|O1|Outcome|Zemaira®|Alpha1-proteinase inhibitor: 60 mg/kg body weight/week intravenous
529001|NCT00261716|B2|Baseline|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529002|NCT00261716|B1|Baseline|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529003|NCT00261716|P2|Participant Flow|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529004|NCT00261716|P1|Participant Flow|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529005|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
529006|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
529007|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
529008|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
529009|NCT00261716|O2|Outcome|Not Employed|Participant indicated he/she was not employed at least part-time within one month of scheduled assessment
529010|NCT00261716|O1|Outcome|Employed|Participant indicated he/she was employed at least part-time within one month of scheduled assessment
529011|NCT00261716|O2|Outcome|IPS and IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~IE: Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529012|NCT00261716|O1|Outcome|IPS and VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~IPS: Individual Placement and Support Evidence based supported employment~VOMI: Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529013|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529014|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529015|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529016|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529017|NCT00261716|O2|Outcome|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529018|NCT00261716|O1|Outcome|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529048|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529049|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529019|NCT00261716|E2|Reported Event|IPS+IE|"Individual placement and support (IPS), a form of evidence-based supported employment with 4 sessions of education about schizophrenia/schizoaffective disorder (IE), as appropriate, prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Illness Education (IE): Four sessions of manualized illness education about schizophrenia/schizoaffective disorder (tailored to the participant diagnosis) prior to each course of a job search"
529020|NCT00261716|E1|Reported Event|IPS+VOMI|"Individual Placement and Support (IPS), a form of evidence-based supported employment with 4 sessions of manualized vocationally-oriented motivational interviewing (VOMI) prior to each course of job searching~Individual Placement and Support (IPS): Evidence based supported employment~Vocationally-Oriented Motivational Interviewing (VOMI): Four sessions of manualized motivational interviewing oriented to employment goals and concerns prior to each course of a job search"
529021|NCT00261495|B3|Baseline|Total|Total of all reporting groups
529022|NCT00261495|B2|Baseline|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529023|NCT00261495|B1|Baseline|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529024|NCT00261495|P2|Participant Flow|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529025|NCT00261495|P1|Participant Flow|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529026|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529027|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529028|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529029|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529030|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529031|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529032|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529033|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529034|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529035|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529036|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529037|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529038|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529039|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529040|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529041|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529042|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529043|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529044|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529045|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529046|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529047|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529625|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
529050|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529051|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529052|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529053|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529054|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529055|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529056|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529057|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529058|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529059|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529060|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529061|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529062|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529063|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529064|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529065|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529066|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529067|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529068|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529069|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529070|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529071|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529072|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529073|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529074|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529075|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529076|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529077|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529078|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529079|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529080|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
531637|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
529081|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529082|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529083|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529084|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529085|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529086|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529087|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529088|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529089|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529090|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529091|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529092|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529093|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529094|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529095|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529096|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529097|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529098|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529099|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529100|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529101|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529102|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529103|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529104|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529105|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529106|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529107|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529108|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529109|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529110|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529111|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
531638|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
529112|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529113|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529114|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529115|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529116|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529117|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529118|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529119|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529120|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529121|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529122|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529123|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529124|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529125|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529126|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529127|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529128|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529129|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529130|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529131|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529132|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529133|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529134|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529135|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529136|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529137|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529138|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529139|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529140|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529141|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529142|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
531639|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
529143|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529144|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529145|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529146|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529147|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529148|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529149|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529150|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529151|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529152|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529153|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529154|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529155|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529156|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529157|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529158|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529159|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529160|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529161|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529162|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529163|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529164|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529165|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529166|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529167|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529168|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529169|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529170|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529171|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529172|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529173|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
531640|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
529174|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529175|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529176|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529177|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529178|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529179|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529180|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529181|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529182|NCT00261495|O2|Outcome|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529183|NCT00261495|O1|Outcome|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529184|NCT00261495|E2|Reported Event|Oxycodone|Initial dose 10 mg (minimum dose), 20 mg, and 40 mg, oral administration, twice daily, 4 weeks (titration phase), 20 weeks (maintenance phase), and 28 weeks (extension phase)
529185|NCT00261495|E1|Reported Event|OROS Hydromorphone HCl|Initial dose 8 mg (minimum dose), 16 mg, or 32 mg (maximum dose), oral administration, once-daily, 4 weeks (titration phase), 20 weeks (maintenance phase), 28 weeks (extension phase)
529186|NCT00261443|B3|Baseline|Total|Total of all reporting groups
529187|NCT00261443|B2|Baseline|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529188|NCT00261443|B1|Baseline|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529189|NCT00261443|P3|Participant Flow|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529190|NCT00261443|P2|Participant Flow|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529191|NCT00261443|P1|Participant Flow|Pre-Randomized Participants|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529192|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529193|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529194|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529195|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529196|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529197|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529198|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529199|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529200|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529201|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529202|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529203|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529204|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529205|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529626|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
529206|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529207|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529208|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529209|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529210|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529211|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529212|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529213|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529214|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529215|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529216|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529217|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529218|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529219|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529220|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529221|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529222|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529223|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529224|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529225|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529226|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529227|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529228|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529229|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529230|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529231|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529232|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529233|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529234|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529235|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529236|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529237|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529238|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
531641|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
529239|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529240|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529241|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529242|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529243|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529244|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529245|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529246|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529247|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529248|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529249|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529250|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529251|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529252|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529253|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529254|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529255|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529256|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529257|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529258|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529259|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529260|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529261|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529262|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529263|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529264|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529265|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529266|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529267|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529268|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529269|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529270|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529271|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
530986|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
529272|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529273|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529274|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529275|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529276|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529277|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529278|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529279|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529280|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529281|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529282|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529283|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529284|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529285|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529286|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529287|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529288|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529289|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529290|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529291|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529292|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529293|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529294|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529295|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529296|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529297|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529298|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529299|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529300|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529301|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529302|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529303|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529304|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
531642|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
529305|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529306|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529307|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529308|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529309|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529310|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529311|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529312|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529313|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529314|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529315|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529316|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529317|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529318|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529319|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529320|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529321|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529322|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529323|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529324|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529325|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529326|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529327|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529328|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529329|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529330|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529331|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529332|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529333|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529334|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529335|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529336|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529337|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529338|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529339|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529340|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529341|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529342|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529343|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529344|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529345|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529346|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529347|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529348|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529349|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529350|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529351|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529352|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529353|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529354|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529355|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529356|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529357|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529358|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529359|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529360|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529361|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529362|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529363|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529364|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529365|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529366|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529367|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529368|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529369|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529370|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529371|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529372|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529373|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529374|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529375|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529376|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529377|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529378|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529379|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529380|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529381|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529382|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529383|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529384|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529385|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529386|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529387|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529388|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529389|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529390|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529391|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529392|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529393|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529394|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529395|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529396|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529397|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529398|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529399|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529400|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529401|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529402|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529403|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529404|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529405|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529406|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529407|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529627|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
529408|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529409|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529410|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529411|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529412|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529413|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529414|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529415|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529416|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529417|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529418|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529419|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529420|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529421|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529422|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529423|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529424|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529425|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529426|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529427|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529428|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529429|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529430|NCT00261443|O2|Outcome|Valproate|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg Depakote/valproic acid oral tablets
529431|NCT00261443|O1|Outcome|Lithium|Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets
529432|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529433|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529434|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529435|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529436|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529437|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529438|NCT00261443|O2|Outcome|Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): aripiprazole 10-mg and 15-mg oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529439|NCT00261443|O1|Outcome|Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and 250-mg and 300-mg oral lithium tablets or 250-mg Depakote/valproic acid oral tablets
529440|NCT00261443|E5|Reported Event|Extension Phase Aripiprazole|Phase 4 (Extension Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529441|NCT00261443|E4|Reported Event|Extension Phase Placebo|Phase 4 (Extension Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529442|NCT00261443|E3|Reported Event|Double-Blind Aripiprazole|Phase 3 (52 Week Assessment of Relapse Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529443|NCT00261443|E2|Reported Event|Double-Blind Placebo|Phase 3 (52 Week Assessment of Relapse Phase): matching placebo oral tablets and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529444|NCT00261443|E1|Reported Event|Single-Blind Aripiprazole|Phase 1 (2 to 8 Week Screening, Washout and Confirmation of Partial Nonresponse Phase): lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml. Phase 2 (13 to 24 Week Stability and Maintenance of Stability Phase): 10-mg, 15-mg, or 30-mg doses of aripiprazole and lithium: 0.6–1.0 mmol/L or valproate 50–125 µg/ml.
529445|NCT00260832|B3|Baseline|Total|Total of all reporting groups
529446|NCT00260832|B2|Baseline|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
529447|NCT00260832|B1|Baseline|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
529448|NCT00260832|P2|Participant Flow|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
529449|NCT00260832|P1|Participant Flow|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
529450|NCT00260832|O2|Outcome|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
529451|NCT00260832|O1|Outcome|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
529452|NCT00260832|E2|Reported Event|Dacogen (Decitabine) Only|20 mg/m^2 Dacogen (decitabine) given as 1-hour infusion once daily for 5 consecutive days every 4 weeks.
529453|NCT00260832|E1|Reported Event|Cytarabine or Supportive Care|Subject's choice of treatment with physician's advice of either supportive care (IV fluids, nutrition, and antibiotics as needed) or cytarabine 20 mg/m^2 given subcutaneously once daily for 10 consecutive days, repeated every 4 weeks. (These represent one intervention.)
529454|NCT00260533|B3|Baseline|Total|Total of all reporting groups
529455|NCT00260533|B2|Baseline|Placebo|Placebo
529456|NCT00260533|B1|Baseline|Atomoxetine|Atomoxetine
529457|NCT00260533|P2|Participant Flow|Placebo|Placebo (matched capsules to atomoxetine)
529458|NCT00260533|P1|Participant Flow|Atomoxetine|Atomoxetine 40-100 mg per day
529459|NCT00260533|O2|Outcome|Placebo|Placebo
529460|NCT00260533|O1|Outcome|Atomoxetine|Atomoxetine
529461|NCT00260533|E2|Reported Event|Placebo|Placebo
529462|NCT00260533|E1|Reported Event|Atomoxetine|Atomoxetine
529463|NCT00260429|B3|Baseline|Total|Total of all reporting groups
529464|NCT00260429|B2|Baseline|Placebo|
529465|NCT00260429|B1|Baseline|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
529466|NCT00260429|P2|Participant Flow|Placebo|
529467|NCT00260429|P1|Participant Flow|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
529468|NCT00260429|O2|Outcome|Placebo|
529469|NCT00260429|O1|Outcome|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
529470|NCT00260429|E2|Reported Event|Placebo|
529471|NCT00260429|E1|Reported Event|AA4500|collagenase clostridium histolyticum 0.58mg injected into metacarpophalangeal (MP) and/or proximal interphalangeal (PIP) joints
529472|NCT00260208|B3|Baseline|Total|Total of all reporting groups
529473|NCT00260208|B2|Baseline|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529474|NCT00260208|B1|Baseline|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529475|NCT00260208|P2|Participant Flow|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529476|NCT00260208|P1|Participant Flow|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529477|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529478|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529479|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529480|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529481|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529482|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529483|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529484|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529485|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529486|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529487|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529488|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529489|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529490|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529491|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
530987|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
529492|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529493|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529494|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529495|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529496|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529497|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529498|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529499|NCT00260208|O2|Outcome|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529500|NCT00260208|O1|Outcome|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529501|NCT00260208|E2|Reported Event|Tacrolimus|Tacrolimus was administered within the first 24 hours post-transplantation at an initial dose of 0.1-0.15 mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally or via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the course of the study, the dose of tacrolimus was adjusted as necessary to achieve and maintain the C0 tacrolimus concentrations within target ranges.
529502|NCT00260208|E1|Reported Event|Cyclosporin A|The first administration of Cyclosporin A (CsA) was within the first 24 hours post-transplantation at an initial dose of 10-15mg/kg/day in 2 divided doses (twice daily at 12-hour interval) either orally, via a nasogastric (NG) tube or intravenously (i.v). Twice daily (b.i.d.) administration was maintained throughout the study period. During the study, it was recommended that the dose of CsA was adjusted, as necessary, to achieve and maintain the C2 or C0 blood CsA concentration within the target ranges.
529503|NCT00260195|B3|Baseline|Total|Total of all reporting groups
529504|NCT00260195|B2|Baseline|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
529505|NCT00260195|B1|Baseline|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529506|NCT00260195|P2|Participant Flow|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
529507|NCT00260195|P1|Participant Flow|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529508|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
529509|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529510|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
529511|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529512|NCT00260195|O2|Outcome|Wait-list Control Group|Waiting list
529513|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529514|NCT00260195|O2|Outcome|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
529515|NCT00260195|O1|Outcome|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529516|NCT00260195|E2|Reported Event|Wait-list Control Group|Students assigned to this group waited while the experimental arm received SSET, and then completed the first follow-up assessment. They then received SSET between the first and second follow-up assessment.
529517|NCT00260195|E1|Reported Event|School-based Cognitive Behavioral Support Group|Ten group lessons facilitated by a teacher or school counselor that focuses on psycho-education, development of a trauma narrative, approaching trauma-related situations, social problem solving, and cognitive skills.
529518|NCT00260065|B1|Baseline|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
529519|NCT00260065|P1|Participant Flow|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
529520|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
529521|NCT00260065|O1|Outcome|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
529522|NCT00260065|E1|Reported Event|Decitabine 20 mg/m2 Intravenous|Decitabine 20 mg/m2 intravenous IV on Days 1-5 of each 28 day cycle.
529523|NCT00259857|B3|Baseline|Total|Total of all reporting groups
529524|NCT00259857|B2|Baseline|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529525|NCT00259857|B1|Baseline|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529526|NCT00259857|P2|Participant Flow|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529527|NCT00259857|P1|Participant Flow|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529528|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529529|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529530|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529531|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529532|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529533|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529534|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529535|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529536|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529537|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529538|NCT00259857|O2|Outcome|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529539|NCT00259857|O1|Outcome|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529580|NCT00259298|B1|Baseline|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529540|NCT00259857|E2|Reported Event|Gr-2:Yr-1/Yr-2: Pbo/Alendronate, Calcium and Vitamin D|Group-2/Year-1, 11 participants will take Placebo,and calcium, and vitamin D (supplements) and in Year-2 they will crossover to Alendronate (study medication), calcium and vitamin D (supplements).
529541|NCT00259857|E1|Reported Event|Gr-1:Yr-1/Yr-2: Alendronate/Pbo, Calcium, Vitamin D|Group-1/Year-1, 11 participants will take Alendronate,(study medication) and calcium, and vitamin D (supplements) and in Year-2 they will crossover to placebo, calcium and vitamin D supplements.
529542|NCT00259740|B3|Baseline|Total|Total of all reporting groups
529543|NCT00259740|B2|Baseline|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
529544|NCT00259740|B1|Baseline|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
529545|NCT00259740|P2|Participant Flow|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
529546|NCT00259740|P1|Participant Flow|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
529547|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
529548|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
529549|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
529550|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
529551|NCT00259740|O2|Outcome|Denosumab 120 mg Q4W - Relapsed|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with relapsed multiple myeloma
529552|NCT00259740|O1|Outcome|Denosumab 120 mg Q4W - Plateau-Phase|Open-label denosumab 120 mg by subcutaneous injection on day 1 of each 28-day cycle with additional loading doses on days 8 and 15 of cycle 1 in participants with plateau-phase multiple myeloma
529553|NCT00259740|E2|Reported Event|Denosumab 120 mg Q4W - Plateau-Phase|
529554|NCT00259740|E1|Reported Event|Denosumab 120 mg Q4W - Relapsed|
529555|NCT00259649|B1|Baseline|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
529556|NCT00259649|P1|Participant Flow|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
529557|NCT00259649|O1|Outcome|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
529558|NCT00259649|E1|Reported Event|Eletriptan|Perimenstrual oral eletriptan 20 mg three times daily starting two days prior to the expected onset of menstruation and continued for a total of 6 days for 3 consecutive months
529559|NCT00259610|B5|Baseline|Total|Total of all reporting groups
529560|NCT00259610|B4|Baseline|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529561|NCT00259610|B3|Baseline|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
529562|NCT00259610|B2|Baseline|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529563|NCT00259610|B1|Baseline|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
529564|NCT00259610|P4|Participant Flow|MTX + Placebo SSZ + HCQ(ST)|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
529565|NCT00259610|P3|Participant Flow|MTX + Placebo Entaneracept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + Etanercept(Placebo) 50mg/qw by injection
529566|NCT00259610|P2|Participant Flow|MTX+ Active SSZ +HCQ|methotrexate (MTX)20mg/qw by mouth(within 12 weeks of entry in study) + sulfasalazine (SSZ) 500mg qd - 1000mg 2qd by mouth /hydroxychloroquine (HCQ)200mg 2qd by mouth
529567|NCT00259610|P1|Participant Flow|MTX + Active Etanercept|Methotrexate (MTX)5mg -20mg/qw by mouth(within 12 weeks of entry in study) + etanercept 50mg/qw by injection
529568|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529569|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
529570|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529571|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
529572|NCT00259610|O4|Outcome|MTX + Step-up SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529573|NCT00259610|O3|Outcome|MTX + Step-up Etanercept|methotrexate (MTX) or MTX + Etanercept
529574|NCT00259610|O2|Outcome|MTX+ Immediate SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529575|NCT00259610|O1|Outcome|MTX + Immediate Etanercept|Methotrexate (MTX) + etanercept
529576|NCT00259610|E4|Reported Event|MTX + Placebo SSZ + HCQ(ST)|methotrexate (MTX) or MTX + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529577|NCT00259610|E3|Reported Event|MTX + Placebo Entaneracept|methotrexate (MTX) or MTX + Etanercept
529578|NCT00259610|E2|Reported Event|MTX+ Active SSZ +HCQ|methotrexate (MTX) + sulfasalazine (SSZ)/hydroxychloroquine (HCQ)
529579|NCT00259610|E1|Reported Event|MTX + Active Etanercept|Methotrexate (MTX) + etanercept
529581|NCT00259298|P1|Participant Flow|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529582|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529583|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529584|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529585|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529586|NCT00259298|O1|Outcome|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529587|NCT00259298|E1|Reported Event|Teriparatide|Participants received teriparatide 20 microgram once daily by subcutaneous injection for 18 months, followed by 6 months off therapy
529588|NCT00259285|B1|Baseline|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529589|NCT00259285|P1|Participant Flow|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529590|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529591|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529592|NCT00259285|O1|Outcome|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529593|NCT00259285|E1|Reported Event|Pemetrexed + Cisplatin|Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 3 cycles Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 3 cycles
529594|NCT00259272|B5|Baseline|Total|Total of all reporting groups
529595|NCT00259272|B4|Baseline|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529596|NCT00259272|B3|Baseline|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529597|NCT00259272|B2|Baseline|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529598|NCT00259272|B1|Baseline|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529599|NCT00259272|P4|Participant Flow|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529600|NCT00259272|P3|Participant Flow|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529601|NCT00259272|P2|Participant Flow|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529602|NCT00259272|P1|Participant Flow|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529603|NCT00259272|O3|Outcome|Cumulative|
529604|NCT00259272|O2|Outcome|Proportion|
529605|NCT00259272|O1|Outcome|Eigen Value|
529606|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529607|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529608|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529609|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529610|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529611|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529612|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529613|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529614|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529615|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529616|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529617|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529618|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529619|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529620|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529621|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529622|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
529628|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
529629|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
529630|NCT00259272|O1|Outcome|Thymic Hypo-Reactivity|As assessed by the investigator according to his clinical experience.
529631|NCT00259272|O3|Outcome|Neither|As assessed by the investigator according to his clinical experience.
529632|NCT00259272|O2|Outcome|Thymic Hyper-Reactivity|As assessed by the investigator according to his clinical experience.
529633|NCT00259272|O1|Outcome|Thymic Hypo-Reactive|As assessed by the investigator according to his clinical experience.
529634|NCT00259272|O1|Outcome|Weight Gain Subgroup|Patients who gained more than 7% of body weight during the study.
529635|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529636|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529637|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529638|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529639|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529640|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529641|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529642|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529643|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529644|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529645|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529646|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529647|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529648|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529649|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529650|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529651|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529652|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529653|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529654|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529655|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529656|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529657|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529658|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529659|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529660|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529661|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529662|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529663|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529664|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529665|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529666|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529667|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529668|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529763|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
529669|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529670|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529671|NCT00259272|O4|Outcome|Depressive Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 5 mg).
529672|NCT00259272|O3|Outcome|Mixed Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529673|NCT00259272|O2|Outcome|Hypomanic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 10 mg)
529674|NCT00259272|O1|Outcome|Manic Episode|olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks (initial dose = 15 mg).
529675|NCT00259272|E1|Reported Event|Olanzapine|Olanzapine: 5 to 20 mg (flexible dose) administered orally as disintegrated tablets, daily for 24 weeks.
529676|NCT00259090|B4|Baseline|Total|Total of all reporting groups
529677|NCT00259090|B3|Baseline|Anastrozole|Anastrozole 1 mg once daily tablet
529678|NCT00259090|B2|Baseline|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529679|NCT00259090|B1|Baseline|Fulvestrant|Fulvestrant 500 mg once monthly injection
529680|NCT00259090|P3|Participant Flow|Anastrozole|Anastrozole 1 mg once daily tablet
529681|NCT00259090|P2|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529682|NCT00259090|P1|Participant Flow|Fulvestrant|Fulvestrant 500 mg once monthly injection
529683|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
529684|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529685|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
529686|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
529687|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529688|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
529689|NCT00259090|O3|Outcome|Anastrozole|Anastrozole 1 mg once daily tablet
529690|NCT00259090|O2|Outcome|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529691|NCT00259090|O1|Outcome|Fulvestrant|Fulvestrant 500 mg once monthly injection
529692|NCT00259090|E3|Reported Event|Anastrozole|Anastrozole 1 mg once daily tablet
529693|NCT00259090|E2|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 500 mg once monthly injection + Anastrozole 1 mg once daily tablet
529694|NCT00259090|E1|Reported Event|Fulvestrant|Fulvestrant 500 mg once monthly injection
529695|NCT00259012|B3|Baseline|Total|Total of all reporting groups
529696|NCT00259012|B2|Baseline|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529697|NCT00259012|B1|Baseline|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529698|NCT00259012|P2|Participant Flow|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529699|NCT00259012|P1|Participant Flow|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529700|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529701|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529702|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529703|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529704|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529705|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529706|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
531643|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
529707|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529708|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529709|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529710|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529711|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529712|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529713|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529714|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529715|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529716|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529717|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529718|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529719|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529720|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529721|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529722|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529723|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529724|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529725|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529726|NCT00259012|O2|Outcome|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529727|NCT00259012|O1|Outcome|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529762|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
529728|NCT00259012|E2|Reported Event|High Dose Pantoprazole (1.2 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 10 mg. This dosing corresponds to approximately 1.2 mg/kg.
529729|NCT00259012|E1|Reported Event|Low Dose Pantoprazole (0.6 mg/kg)|Patients weighing 2.5 to <7 kg received pantoprazole sodium enteric-coated spheroid suspension daily 2.5 mg. Patients weighing ≥7 to ≤15 kg received pantoprazole sodium enteric-coated spheroid suspension daily 5 mg. This dosing corresponds to approximately 0.6 mg/kg.
529730|NCT00258908|B1|Baseline|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529731|NCT00258908|P1|Participant Flow|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529732|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529733|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529734|NCT00258908|O1|Outcome|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529735|NCT00258908|E1|Reported Event|ADACEL™ Group|Participants received 1 dose of ADACEL™ (TdcP vaccine)
529736|NCT00258895|B3|Baseline|Total|Total of all reporting groups
529737|NCT00258895|B2|Baseline|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529738|NCT00258895|B1|Baseline|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529739|NCT00258895|P2|Participant Flow|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529740|NCT00258895|P1|Participant Flow|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529741|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529742|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529743|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529744|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529745|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529746|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529747|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529748|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529749|NCT00258895|O2|Outcome|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529750|NCT00258895|O1|Outcome|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529751|NCT00258895|E2|Reported Event|Pentacel®-Primed|Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.
529752|NCT00258895|E1|Reported Event|DAPTACEL®-Primed|Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
529753|NCT00258882|B3|Baseline|Total|Total of all reporting groups
529754|NCT00258882|B2|Baseline|Control Groups|Non-pregnant individuals matched by age to individuals who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
529755|NCT00258882|B1|Baseline|Adacel Vaccine Group|"Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.~Each non-pregnant recipient served as their own control for evaluation of acute events. Rates of events occurring during Day 0 to 60 following vaccination were compared to rates of events occurring during Day 61 to 120 following vaccination (Short-term surveillance)"
529756|NCT00258882|P2|Participant Flow|Control Groups|For each pregnant individual receiving Adacel vaccine, 3 control individuals not given Adacel vaccine were matched on age and month of their first positive pregnancy test. For non-pregnant individuals, age-matched individuals were identified who received Td vaccine but no live virus vaccine during the year prior to initiation of the study during the same month as Adacel vaccine recipient, but 1 year earlier.
529757|NCT00258882|P1|Participant Flow|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period were sub-grouped as 1) pregnant at the time of vaccination or who became pregnant within 28 days after vaccination and 2) non-pregnant recipients classified by age at vaccination.
529758|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
529759|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination
529760|NCT00258882|O2|Outcome|Control Groups|Age matched pregnant controls who did not receive Adacel vaccine.
529761|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period and were pregnant at the time of vaccination or became pregnant within 28 days after vaccination.
529764|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
529765|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
529766|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
529767|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
529768|NCT00258882|O2|Outcome|Control Groups|Age matched participants who received Td vaccine but no live virus vaccine, during the year prior to initiation of study during the same month as the Adacel vaccine recipient, 1 year earlier.
529769|NCT00258882|O1|Outcome|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period.
529770|NCT00258882|E1|Reported Event|Adacel Vaccine Group|Participants who received Adacel vaccine during the study period. They are sub-grouped as those pregnant at the time of vaccination with Adacel or who became pregnant within 28 days after vaccination and other recipients are classified by age at vaccination.
529771|NCT00258856|B5|Baseline|Total|Total of all reporting groups
529772|NCT00258856|B4|Baseline|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
529773|NCT00258856|B3|Baseline|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
529774|NCT00258856|B2|Baseline|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
529775|NCT00258856|B1|Baseline|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
529776|NCT00258856|P4|Participant Flow|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination.
529777|NCT00258856|P3|Participant Flow|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
529778|NCT00258856|P2|Participant Flow|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
529779|NCT00258856|P1|Participant Flow|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
529780|NCT00258856|O4|Outcome|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
529781|NCT00258856|O3|Outcome|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
529782|NCT00258856|O2|Outcome|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
529783|NCT00258856|O1|Outcome|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
529784|NCT00258856|E4|Reported Event|Meningococcal Vaccine-naïve Group 4|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 5 and Day 14 after Menactra® vaccination
529785|NCT00258856|E3|Reported Event|Meningococcal Vaccine-naïve Group 3|Participants have never received a Meningococcal vaccine in the past. Participants provided serum sample before vaccination and on Day 3 and Day 7 after Menactra® vaccination.
529786|NCT00258856|E2|Reported Event|Menactra® Group 2|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 5 and Day 14 after booster vaccination"
529787|NCT00258856|E1|Reported Event|Menactra® Group 1|"Participants received Menactra® in Study 603-02.~Participants provided serum sample before vaccination and on Day 3 and Day 7 after booster vaccination"
529788|NCT00258830|B3|Baseline|Total|Total of all reporting groups
529789|NCT00258830|B2|Baseline|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529790|NCT00258830|B1|Baseline|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529791|NCT00258830|P2|Participant Flow|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529792|NCT00258830|P1|Participant Flow|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529793|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529794|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529795|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529796|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529797|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529798|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529799|NCT00258830|O2|Outcome|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529840|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529800|NCT00258830|O1|Outcome|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529801|NCT00258830|E2|Reported Event|Age 60 Years and Older|Participants aged 60 years and older at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529802|NCT00258830|E1|Reported Event|Age 18 to 59 Years|Participants aged 18 to 59 years at enrollment received 0.5 mL of Fluzone® vaccine intramuscularly.
529803|NCT00258817|B3|Baseline|Total|Total of all reporting groups
529804|NCT00258817|B2|Baseline|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529805|NCT00258817|B1|Baseline|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529806|NCT00258817|P2|Participant Flow|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529807|NCT00258817|P1|Participant Flow|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529808|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529809|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529810|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529811|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529812|NCT00258817|O2|Outcome|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529813|NCT00258817|O1|Outcome|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529814|NCT00258817|E2|Reported Event|Influenza Vaccine-primed Group|Participants have received Influenza virus vaccine in the past. They received 0.25 mL of Fluzone® vaccine on Day 0.
529815|NCT00258817|E1|Reported Event|Influenza Vaccine-naive Group|Participants have never received Influenza virus vaccine. They received 0.25 mL of Fluzone® vaccine on Day 0 and Day 28, respectively.
529816|NCT00258674|B4|Baseline|Total|Total of all reporting groups
529817|NCT00258674|B3|Baseline|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529818|NCT00258674|B2|Baseline|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529819|NCT00258674|B1|Baseline|Claims|Physician feedback of patient process measures using Medicare claims data
529820|NCT00258674|P3|Participant Flow|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529821|NCT00258674|P2|Participant Flow|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529822|NCT00258674|P1|Participant Flow|Claims|Physician feedback of patient process measures using Medicare claims data
529823|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529824|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529825|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529826|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529827|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529828|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529829|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529830|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529831|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529832|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529833|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529834|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529835|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529836|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529837|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529838|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529839|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
531644|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
529841|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529842|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529843|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529844|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529845|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529846|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529847|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529848|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529849|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529850|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529851|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529852|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529853|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529854|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529855|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529856|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529857|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529858|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529859|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529860|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529861|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529862|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529863|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529864|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529865|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529866|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529867|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529868|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529869|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529870|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529871|NCT00258674|O3|Outcome|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529872|NCT00258674|O2|Outcome|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529873|NCT00258674|O1|Outcome|Claims|Physician feedback of patient process measures using Medicare claims data
529874|NCT00258674|E3|Reported Event|Claims+MR+Diabetes Resource Nurse|Physician Feedback of patient process measures using Medicare claims data and medical record-abstracted clinical measures, plus patient access to a diabetes resource nurse.
529875|NCT00258674|E2|Reported Event|Claims+MR|Physician feedback of patient process measures using Medicare claims data plus medical record-abstracted clinical measures
529876|NCT00258674|E1|Reported Event|Claims|Physician feedback of patient process measures using Medicare claims data
529877|NCT00258440|B4|Baseline|Total|Total of all reporting groups
529878|NCT00258440|B3|Baseline|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
529879|NCT00258440|B2|Baseline|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
529944|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529880|NCT00258440|B1|Baseline|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
529881|NCT00258440|P3|Participant Flow|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
529882|NCT00258440|P2|Participant Flow|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
529883|NCT00258440|P1|Participant Flow|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
529884|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
529885|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
529886|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
529887|NCT00258440|O3|Outcome|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
529888|NCT00258440|O2|Outcome|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
529889|NCT00258440|O1|Outcome|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
529890|NCT00258440|E3|Reported Event|Interval Dosing (Epoetin Alfa) Non PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have NOT consented to pharmacokinetics (PK) testing.
529891|NCT00258440|E2|Reported Event|Interval Dosing (Epoetin Alfa) PK Group|Patients receive epoetin alfa SC once weekly until hematocrit is > 36% OR hemoglobin reaches a value of 12 g/dL. Patients then proceed to maintenance therapy. Patients who have consented to pharmacokinetics (PK) testing.
529892|NCT00258440|E1|Reported Event|Weekly Procrit (Epoetin Alfa) Dosing|Patients receive epoetin alfa subcutaneously (SC) once weekly. Treatment continues for 24 weeks in the absence of unacceptable toxicity. Patients then proceed to maintenance therapy.
529893|NCT00258362|B1|Baseline|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin. This group excludes those patients with recurrent endometrial cancer.
529894|NCT00258362|P1|Participant Flow|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
529895|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced or recurrent endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
529896|NCT00258362|O1|Outcome|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
529897|NCT00258362|E1|Reported Event|Patients With Endometrial Cancer|Patients with advanced endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (4500 cGy) and followed by 3 courses of consolidation docetaxel/carboplatin.
529898|NCT00258349|B1|Baseline|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
529899|NCT00258349|P1|Participant Flow|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat: 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle.
529900|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
529901|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
529902|NCT00258349|O1|Outcome|Vorinostat +Trastuzumab|"Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks;~Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle"
529903|NCT00258349|E2|Reported Event|Vorinostat +Trastuzumab (Phase I)|phase I patients for identify maximum tolerated dose
529904|NCT00258349|E1|Reported Event|Vorinostat +Trastuzumab (Phase II)|Trastuzumab: 6 mg/kg once on Day 1, infused over 90 minutes, every 3 weeks; Vorinostat 200 mg of SAHA orally twice a day, daily for 14 days out of a 21-day cycle
529905|NCT00258310|B1|Baseline|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
529906|NCT00258310|P1|Participant Flow|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
529907|NCT00258310|O1|Outcome|Capecitabine|"Capecitabine 1000mg/day for one year~capecitabine~adjuvant therapy"
529908|NCT00258310|E1|Reported Event|Capcitabine|"Caoecutabube 1000mg/day for one year~capecitabine~adjuvant therapy"
529945|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529909|NCT00258206|B1|Baseline|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
529910|NCT00258206|P1|Participant Flow|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
529911|NCT00258206|O1|Outcome|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
529912|NCT00258206|E1|Reported Event|Rituximab + Cyclophosphamide|Rituximab 375 mg/m^2 on Days -10 and -7; Cyclophosphamide 50 mg/kg on days -3, -2, -1, and 0; Rituximab 375 mg/m^2 weekly x4 after platelet counts recover; For patients achieving at least stable disease, rituximab maintenance 375 mg/m^2 once each during months 3, 6, 9, and 12
529913|NCT00258154|B3|Baseline|Total|Total of all reporting groups
529914|NCT00258154|B2|Baseline|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529915|NCT00258154|B1|Baseline|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529916|NCT00258154|P2|Participant Flow|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529917|NCT00258154|P1|Participant Flow|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529918|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529919|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529920|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529921|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529922|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529923|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529924|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529925|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529926|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529927|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529928|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529929|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529930|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529931|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529932|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529933|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529934|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529935|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529936|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529937|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529938|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529939|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529940|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529941|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529942|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529943|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
530077|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
529946|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529947|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529948|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529949|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529950|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529951|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529952|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529953|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529954|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529955|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529956|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529957|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529958|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529959|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529960|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529961|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529962|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529963|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529964|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529965|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529966|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529967|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529968|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529969|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529970|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529971|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529972|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529973|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529974|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529975|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529976|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529977|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529978|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529979|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529980|NCT00258154|O2|Outcome|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529981|NCT00258154|O1|Outcome|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529982|NCT00258154|E2|Reported Event|Placebo + INFANRIX Hexa|For subjects in Group 2, 3 concomitant doses of placebo were administered concomitantly with INFANRIX™ hexa at intervals of 4 to 6 weeks.
529983|NCT00258154|E1|Reported Event|RotaTeq™ + INFANRIX Hexa|Subjects in Group 1 received 3 concomitant doses of RotaTeq™ and INFANRIX™ hexa ≥28 to ≤42 days apart.
529984|NCT00258011|B1|Baseline|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
529985|NCT00258011|P1|Participant Flow|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
529986|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
529987|NCT00258011|O1|Outcome|Aldurazyme (Laronidase) Treatment|Patients received weekly infusions of Aldurazyme (laronidase) at an intravenous dose of 100 Units/kg (0.58 mg/kg) body weight (labeled dose) for up to 73 weeks.
529988|NCT00258011|E1|Reported Event|Aldurazyme|Aldurazyme
529989|NCT00257933|B3|Baseline|Total|Total of all reporting groups
529990|NCT00257933|B2|Baseline|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
529991|NCT00257933|B1|Baseline|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
529992|NCT00257933|P2|Participant Flow|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
529993|NCT00257933|P1|Participant Flow|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
529994|NCT00257933|O2|Outcome|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
529995|NCT00257933|O1|Outcome|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
529996|NCT00257933|E2|Reported Event|Lower Dose Prednisolone|Lower dose prednisolone: 1 mg/kg (maximum 30mg)of oral prednisolone every 12 hours alternating with placebo
529997|NCT00257933|E1|Reported Event|High Dose Prednisolone|High dose prednisolone: 1 mg/kg of oral prednisolone (maximum 30mg) every 6 hours
529998|NCT00257920|B3|Baseline|Total|Total of all reporting groups
529999|NCT00257920|B2|Baseline|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
530000|NCT00257920|B1|Baseline|Zemplar First|6 mcg Zemplar Injection QOD for 6 doses in Period 1 and 3.6 mcg Hectorol Injection QOD for 6 doses in Period 2
530001|NCT00257920|P2|Participant Flow|Hectorol First|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 and 6 mcg Zemplar Injection QOD for 6 doses in Period 2
530002|NCT00257920|P1|Participant Flow|Zemplar First|6 mcg Zemplar Injection every other day (QOD) for 6 doses in Period 1 and 3.6 mcg Hectorol Injection for 6 doses in Period 2
530003|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
530004|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
530005|NCT00257920|O2|Outcome|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2.
530006|NCT00257920|O1|Outcome|Zemplar|6 mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2
530007|NCT00257920|E2|Reported Event|Hectorol|3.6 mcg Hectorol Injection QOD for 6 doses in Period 1 or Period 2
530008|NCT00257920|E1|Reported Event|Zemplar|6mcg Zemplar Injection QOD for 6 doses in Period 1 or Period 2.
530009|NCT00257894|B3|Baseline|Total|Total of all reporting groups
530010|NCT00257894|B2|Baseline|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530011|NCT00257894|B1|Baseline|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530012|NCT00257894|P2|Participant Flow|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530013|NCT00257894|P1|Participant Flow|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530014|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530015|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530016|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530017|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530018|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530019|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530020|NCT00257894|O2|Outcome|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530021|NCT00257894|O1|Outcome|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530022|NCT00257894|E2|Reported Event|Placebo Condition|Placebo capsules identical to active medication, 3/day for 12 days.
530023|NCT00257894|E1|Reported Event|Baclofen Condition|Baclofen taken orally for 12 days total up to 40 mg/day maximum, divided into 3 equal portions each day. Participants receive 12 mg/day the first 3 days, 30 mg/day the next 3 days, and 40 mg/day on Days 7, 8, 9. Testing is on day 10 after the first dose is taken, with downward titration days 10-12 of 30 mg on Day 10, 20 mg on Day 11 and 10 mg on Day 12.
530024|NCT00257686|B7|Baseline|Total|Total of all reporting groups
530025|NCT00257686|B6|Baseline|Pravastatin 40 mg|Pravastatin 40 mg once daily
530026|NCT00257686|B5|Baseline|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
530027|NCT00257686|B4|Baseline|Pravastatin 20 mg|Pravastatin 20 mg once daily
530028|NCT00257686|B3|Baseline|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
530029|NCT00257686|B2|Baseline|Pravastatin 10 mg|Pravastatin 10 mg once daily
530030|NCT00257686|B1|Baseline|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
530031|NCT00257686|P6|Participant Flow|Pravastatin 40 mg|Pravastatin 40 mg once daily
530032|NCT00257686|P5|Participant Flow|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
530033|NCT00257686|P4|Participant Flow|Pravastatin 20 mg|Pravastatin 20 mg once daily
530034|NCT00257686|P3|Participant Flow|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
530035|NCT00257686|P2|Participant Flow|Pravastatin 10 mg|Pravastatin 10 mg once daily
530036|NCT00257686|P1|Participant Flow|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
530037|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
530038|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
530039|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
530040|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
530041|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
530042|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
530043|NCT00257686|O6|Outcome|Pravastatin 40 mg|Pravastatin 40 mg once daily
530044|NCT00257686|O5|Outcome|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
530045|NCT00257686|O4|Outcome|Pravastatin 20 mg|Pravastatin 20 mg once daily
530046|NCT00257686|O3|Outcome|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
530047|NCT00257686|O2|Outcome|Pravastatin 10 mg|Pravastatin 10 mg once daily
530048|NCT00257686|O1|Outcome|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
530049|NCT00257686|E6|Reported Event|Pravastatin 40 mg|Pravastatin 40 mg once daily
530050|NCT00257686|E5|Reported Event|Pitavastatin 4 mg|Pitavastatin 4 mg once daily
530051|NCT00257686|E4|Reported Event|Pravastatin 20 mg|Pravastatin 20 mg once daily
530052|NCT00257686|E3|Reported Event|Pitavastatin 2 mg|Pitavastatin 2 mg once daily
530053|NCT00257686|E2|Reported Event|Pravastatin 10 mg|Pravastatin 10 mg once daily
530054|NCT00257686|E1|Reported Event|Pitavastatin 1 mg|Pitavastatin 1 mg once daily
530055|NCT00257660|B3|Baseline|Total|Total of all reporting groups
530056|NCT00257660|B2|Baseline|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530057|NCT00257660|B1|Baseline|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530058|NCT00257660|P2|Participant Flow|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530059|NCT00257660|P1|Participant Flow|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530060|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530061|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530062|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530063|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530064|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530065|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530066|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530067|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530068|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530069|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530070|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530071|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530072|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530073|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530074|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530075|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530076|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530988|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530078|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530079|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530080|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530081|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530082|NCT00257660|O2|Outcome|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530083|NCT00257660|O1|Outcome|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530084|NCT00257660|E2|Reported Event|Placebo|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530085|NCT00257660|E1|Reported Event|Dysport 500 Units|Single intramuscular injection into the clinically indicated neck muscles in a single dosing session wherever possible
530086|NCT00257608|B3|Baseline|Total|Total of all reporting groups
530087|NCT00257608|B2|Baseline|Bevacizumab + Erlotinib|Participants received Bevacizumab 15 mg/kg IV on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily
530088|NCT00257608|B1|Baseline|Bevacizumab + Placebo|Participants received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily
530089|NCT00257608|P3|Participant Flow|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530090|NCT00257608|P2|Participant Flow|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530091|NCT00257608|P1|Participant Flow|Bevacizumab + Chemotherapy|Participants received one of six chemotherapy regimens (Carboplatin + Paclitaxel or Carboplatin + Gemcitabine or Carboplatin + Docetaxel or Cisplatin + Gemcitabine or Cisplatin + Docetaxel / Cisplatin + vinorelbine) followed by Bevacizumab on Day 1 of each cycle up to 4 cycles.
530092|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530093|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530094|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530095|NCT00257608|O1|Outcome|Bevacizumab + Placebo|"Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib.~orally daily."
530096|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530097|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530098|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
530099|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530100|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
530101|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530102|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530103|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530104|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530105|NCT00257608|O5|Outcome|Other|Included participants who received Cisplatin + Docetaxel or Cisplatin + vinorelbine, participants who received only one of the two chemotherapies planned followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530106|NCT00257608|O4|Outcome|Cisplatin + Gemcitabine|Participants received IV dose of Cisplatin 80 mg/m^2 on Day 1 of each 21-day cycle and Gemcitabine 1000-1250 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530107|NCT00257608|O3|Outcome|Carboplatin + Docetaxel|Participants received IV dose of Carboplatin at a dose based on the AUC of of 6 mg/mL × min and Docetaxel 75 mg/m^2, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
530486|NCT00255970|E2|Reported Event|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530108|NCT00257608|O2|Outcome|Carboplatin + Gemcitabine|Participants received IV dose of Carboplatin at a dose based on the AUC of 5 mg/mL × min on Day 1 of each 21-day cycle and Gemcitabine 1200 mg/m^2 on Day 1 and Day 8 followed by Bevacizumab of each 21-day cycle up to 4 cycles.
530109|NCT00257608|O1|Outcome|Carboplatin + Paclitaxel|Participants received Intravenous (IV) dose of Carboplatin at a dose based on an area under the concentration-time curve (AUC) of 6 milligram /milliliter (mg/mL) × minute (min) and Paclitaxel 200 milligram per square meter (mg/m^2) over 3 hours, respectively followed by Bevacizumab on Day 1 of each 21-day cycle up to 4 cycles.
530110|NCT00257608|O2|Outcome|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530111|NCT00257608|O1|Outcome|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530112|NCT00257608|E2|Reported Event|Bevacizumab + Erlotinib|Participants who completed four cycles of chemotherapy + bevacizumab received received IV dose of Bevacizumab 15 mg/kg on Day 1 of every 21-day cycle along with Erlotinib as 150 mg per day orally daily.
530113|NCT00257608|E1|Reported Event|Bevacizumab + Placebo|Participants who completed four cycles of chemotherapy + bevacizumab received Bevacizumab 15 milligram per kilogram (mg/kg) intravenously (IV) on Day 1 of every 21-day cycle along with matched Placebo to Erlotinib orally daily.
530114|NCT00257556|B3|Baseline|Total|Total of all reporting groups
530115|NCT00257556|B2|Baseline|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530116|NCT00257556|B1|Baseline|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530117|NCT00257556|P2|Participant Flow|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530118|NCT00257556|P1|Participant Flow|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530119|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530120|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530121|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530122|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530123|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530124|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530125|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530126|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530127|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530128|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530129|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530130|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530131|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530132|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530133|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530134|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530135|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530136|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530137|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530138|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530139|NCT00257556|O2|Outcome|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530140|NCT00257556|O1|Outcome|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530141|NCT00257556|E2|Reported Event|Follitropin Alfa|A genetically engineered substitute for follicle stimulating hormone (recombinant FSH (rFSH)).
530142|NCT00257556|E1|Reported Event|Menotrophin|Highly purified menotrophin sourced from human menopausal gonadotrophin (hMG)
530143|NCT00257322|B1|Baseline|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
530144|NCT00257322|P1|Participant Flow|Chemo Therapy and GM-CSF|Granulocyte-macrophage colony-stimulating factor (GM-CSF) 250ug/m^2 SQ QD with a cap of 500mcg SQ QD
530145|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
530146|NCT00257322|O1|Outcome|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
530147|NCT00257322|E1|Reported Event|Chemo Therapy and GM-CSF|Granulocyte-Macrophage Colony-Stimulating Factor
530148|NCT00257309|B3|Baseline|Total|Total of all reporting groups
530149|NCT00257309|B2|Baseline|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
530150|NCT00257309|B1|Baseline|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
530151|NCT00257309|P2|Participant Flow|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
530152|NCT00257309|P1|Participant Flow|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
530153|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
530154|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
530155|NCT00257309|O2|Outcome|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
530156|NCT00257309|O1|Outcome|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
530157|NCT00257309|E2|Reported Event|Primary Angioplasty|"Primary angioplasty~Primary angioplasty"
530158|NCT00257309|E1|Reported Event|Thrombolysis|"Weight adjusted tenecteplase bolus + Unfrationated heparin~Tenecteplase + UFH (+ clopidogrel, since 01/97)"
530159|NCT00257192|B3|Baseline|Total|Total of all reporting groups
530160|NCT00257192|B2|Baseline|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530161|NCT00257192|B1|Baseline|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530162|NCT00257192|P2|Participant Flow|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530163|NCT00257192|P1|Participant Flow|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530164|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530165|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530166|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530167|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530168|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530169|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530170|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530171|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530487|NCT00255970|E1|Reported Event|Regenafil|Regenafil graft
530172|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530173|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530174|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530175|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530176|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530177|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530178|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530179|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530180|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530181|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530182|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530183|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530184|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530239|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530488|NCT00255840|B3|Baseline|Total|Total of all reporting groups
531085|NCT00252967|O1|Outcome|Placebo|
530185|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530186|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530187|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530188|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530189|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530190|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530191|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530192|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530193|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530194|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530195|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530196|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530197|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530264|NCT00256984|E1|Reported Event|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530265|NCT00256750|B4|Baseline|Total|Total of all reporting groups
530198|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530199|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530200|NCT00257192|O2|Outcome|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530201|NCT00257192|O1|Outcome|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530202|NCT00257192|E2|Reported Event|Placebo|Placebo matching ziprasidone administration: PO capsules administered BID) with meals; titrated from a starting dose of 20 mg/day over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kg; target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530203|NCT00257192|E1|Reported Event|Ziprasidone|Oral (PO) capsules administered twice daily (BID) with meals; titrated from a starting dose of 20 milligrams per day (mg/day) over 2 weeks with dose increases of 20 mg/day every second day up to a target dose range of 120 to 160 mg/day for subjects with body weight ≥ 45 kilograms (kg); target dose for subjects with body weight < 45 kg is 60 to 80 mg/day. After titration dose is attained, flexible dosing range of 80 to 160 (if body weight ≥ 45 kg) or 40 to 80 mg/day (if body weight < 45 kg) for duration of the study.
530204|NCT00257166|B3|Baseline|Total|Total of all reporting groups
530205|NCT00257166|B2|Baseline|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530206|NCT00257166|B1|Baseline|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530207|NCT00257166|P2|Participant Flow|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530208|NCT00257166|P1|Participant Flow|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530209|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530210|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530211|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530212|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530213|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530266|NCT00256750|B3|Baseline|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530214|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530215|NCT00257166|O2|Outcome|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530216|NCT00257166|O1|Outcome|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530217|NCT00257166|E2|Reported Event|Placebo|Placebo matched to ziprasidone capsule orally twice daily up to Week 4.
530218|NCT00257166|E1|Reported Event|Ziprasidone|Ziprasidone capsule administered orally in 2 divided doses daily in the morning and evening with a starting dose of ziprasidone 20 milligram per day (mg/day) as an evening dose on Day 1. This was followed by dose escalation of 20 mg/day every other day up to a target dose of ziprasidone 120 to 160 mg/day for participants with greater than or equal to [>=] 45 kilogram [kg] weight and ziprasidone 60 to 80 mg/day for participants with less than [<] 45 kg weight over 2 weeks, as per investigator’s discretion. Flexible dosing of ziprasidone capsule 80 to 160 mg/day for participants with >= 45 kg weight and ziprasidone capsule 40 to 80 mg/day for participants with <45 kg weight orally in 2 divided doses daily in the morning and evening up to Week 4, as per investigator's discretion.
530219|NCT00257010|B1|Baseline|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530220|NCT00257010|P1|Participant Flow|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530221|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530222|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530223|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530224|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530225|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530226|NCT00257010|O1|Outcome|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530227|NCT00257010|E1|Reported Event|Almotriptan Malate|Participants received 12.5 mg almotriptan malate tablet by mouth after the onset of migraine headache pain.
530228|NCT00256997|B3|Baseline|Total|Total of all reporting groups
530229|NCT00256997|B2|Baseline|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530230|NCT00256997|B1|Baseline|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530231|NCT00256997|P2|Participant Flow|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530232|NCT00256997|P1|Participant Flow|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530233|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530234|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530235|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530236|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530237|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530238|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530240|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530241|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530242|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530243|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530244|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530245|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530246|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530247|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530248|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530249|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530250|NCT00256997|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530251|NCT00256997|O2|Outcome|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530252|NCT00256997|O1|Outcome|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530253|NCT00256997|E2|Reported Event|Oral Atypical Antipsychotic|Oral atypical antipsychotic was administered as per local label practice for 24 months. Participants switched to another atypical oral therapy as per Investigator’s discretion.
530254|NCT00256997|E1|Reported Event|Risperidone Long-Acting Injection (LAI)|Risperidone LAI 25 milligram (mg), 37.5 mg or 50 mg intramuscular (injection of a substance into a muscle) injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was also administered in the first 3 weeks following the dose increase. Duration of treatment was 24 months.
530255|NCT00256984|B1|Baseline|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530256|NCT00256984|P1|Participant Flow|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530257|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530258|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530259|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530260|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530261|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530262|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530263|NCT00256984|O1|Outcome|Stapled Trans-Anal Rectal Resection (STARR)|STARR procedure (an anterior and posterior, full-thickness stapling and resection of the rectal wall) to correct Obstructive Defecation Syndrome symptoms utilizing the TransStar Circular Stapler
530478|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530479|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
530267|NCT00256750|B2|Baseline|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530268|NCT00256750|B1|Baseline|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530269|NCT00256750|P3|Participant Flow|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530270|NCT00256750|P2|Participant Flow|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530271|NCT00256750|P1|Participant Flow|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530272|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530273|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530274|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530275|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530276|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530277|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530278|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530279|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530280|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530281|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530282|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530283|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530284|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530285|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530286|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530287|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530288|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530289|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530290|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530291|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530292|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530293|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530294|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530295|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530296|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530297|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530298|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530299|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530300|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530301|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530302|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530303|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530304|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530305|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530306|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530307|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530308|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530309|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530310|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530311|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530312|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530313|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530314|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530315|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530316|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530317|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530318|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
531086|NCT00252967|O2|Outcome|Atorvastatin|
530319|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530320|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530321|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530322|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530323|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530324|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530325|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530326|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530327|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530328|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530329|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530330|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530331|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530332|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530333|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530334|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530335|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530336|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530337|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530338|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530339|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530340|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530341|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530342|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530343|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530344|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530480|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530345|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530346|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530347|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530348|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530349|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530350|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530351|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530352|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530353|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530354|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530355|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530356|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530357|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530358|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530359|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530360|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530361|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530362|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530363|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530364|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530365|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530366|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530367|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530368|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530369|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530370|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530481|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
530482|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530371|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530372|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530373|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530374|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530375|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530376|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530377|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530378|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530379|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530380|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530381|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530382|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530383|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530384|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530385|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530386|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530387|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530388|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530389|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530390|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530391|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530392|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530393|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530394|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530395|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530396|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530483|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
530484|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530397|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530398|NCT00256750|O3|Outcome|Belatacept MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 mg/kg every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530399|NCT00256750|O2|Outcome|Belatacept LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530400|NCT00256750|O1|Outcome|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530401|NCT00256750|E3|Reported Event|Belatacept - MI|Belatacept MI (more intensive): solution, IV, 10mg/kg: Days 1 and 5, Weeks 2, 4, 6, 8, 10,12, 16, 20, and 24, then 5 milligrams/kilogram (mg/kg) every 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530402|NCT00256750|E2|Reported Event|Belatacept - LI|Belatacept LI (less intensive): solution, intravenous (IV), 10 milligrams/kilogram (mg/kg): Days 1 and 5, Weeks 2, 4, 8 and 12, then 5 mg/kg every (q) 4 weeks, q 4 weeks, 36 months (ST), 5 mg/kg every 4 weeks, q 4 weeks, 24 months (LT)
530403|NCT00256750|E1|Reported Event|Cyclosporine|"Cyclosporine (CsA): tablet, oral~1st month target: 150-300 nanogram/meter (ng/m) After 1st month target: 100-250 nanogram/milliliter (ng/mL), daily, 36 months (short term = ST), 100-250 ng/mL, daily, 24 months (long term = LT)"
530404|NCT00256724|B3|Baseline|Total|Total of all reporting groups
530405|NCT00256724|B2|Baseline|Active ITD|active impedance threshold device
530406|NCT00256724|B1|Baseline|Sham ITD|sham Impedance Threshold Device
530407|NCT00256724|P2|Participant Flow|Active ITD|active impedance threshold device
530408|NCT00256724|P1|Participant Flow|Sham ITD|sham Impedance Threshold Device
530409|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
530410|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
530411|NCT00256724|O2|Outcome|Active ITD|active impedance threshold device
530412|NCT00256724|O1|Outcome|Sham ITD|sham Impedance Threshold Device
530413|NCT00256724|E2|Reported Event|Active ITD|active impedance threshold device
530414|NCT00256724|E1|Reported Event|Sham ITD|sham Impedance Threshold Device
530415|NCT00256698|B3|Baseline|Total|Total of all reporting groups
530416|NCT00256698|B2|Baseline|Anastrozole|Anastrozole 1 mg
530417|NCT00256698|B1|Baseline|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530418|NCT00256698|P2|Participant Flow|Anastrozole|Anastrozole 1 mg
530419|NCT00256698|P1|Participant Flow|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530420|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530421|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530422|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530423|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530424|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530425|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530426|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530427|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530428|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530429|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530430|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530431|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530432|NCT00256698|O2|Outcome|Anastrozole|Anastrozole 1 mg
530433|NCT00256698|O1|Outcome|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530434|NCT00256698|E2|Reported Event|Anastrozole|Anastrozole 1 mg
530435|NCT00256698|E1|Reported Event|Fulvestrant + Anastrozole|Fulvestrant 250 mg Loading Dose Regimen + Anastrozole 1 mg
530436|NCT00256295|B1|Baseline|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530437|NCT00256295|P1|Participant Flow|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530438|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530439|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530440|NCT00256295|O1|Outcome|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530441|NCT00256295|E1|Reported Event|Gemcitabine Plus Oxaliplatin|"Gemcitabine given 1000 mg/m2 IV over 100 minutes Every 21 days. Oxaliplatin given 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days.~Gemcitabine : 1000 mg/m2 IV over 100 minutes Every 21 days~Oxaliplatin : 65 mg/m2 IV over 120 minutes immediately following gemcitabine Every 21 days"
530442|NCT00256243|B1|Baseline|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
530443|NCT00256243|P1|Participant Flow|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
530444|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
530445|NCT00256243|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6) This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour.
530446|NCT00256243|E1|Reported Event|Chemotherapy With GM-CSF|"Doxorubicin and Cyclophosphamide (AC) Followed by Weekly Carboplatin/Paclitaxel with GM-CSF (day 2-6)~This regimen consists of intravenous administration of doxorubicin (Adriamycin) followed by cyclophosphamide (Cytoxan) every 14 days for a total of four cycles, unless stable disease or clinical progression is documented. Two weeks after completion of the last dose of AC, weekly Carboplatin/paclitaxel will be given for 3 weeks, followed by 1 week of rest, for a total of 12. Each clinic visit will last approximately 1 hour."
530447|NCT00256204|B5|Baseline|Total|Total of all reporting groups
530448|NCT00256204|B4|Baseline|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530449|NCT00256204|B3|Baseline|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530450|NCT00256204|B2|Baseline|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530451|NCT00256204|B1|Baseline|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530452|NCT00256204|P4|Participant Flow|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530453|NCT00256204|P3|Participant Flow|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530454|NCT00256204|P2|Participant Flow|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530455|NCT00256204|P1|Participant Flow|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530456|NCT00256204|O4|Outcome|2mg Delayed Start|+1mg Delayed Start: see 1st column
530457|NCT00256204|O3|Outcome|2mg Early Start|2mg early start active treatment arm (72 weeks active)
530458|NCT00256204|O2|Outcome|1mg Early Start|1mg early start active treatment arm (72 weeks active)
530459|NCT00256204|O1|Outcome|1mg Delayed Start|+ 2 mg Delayed Start: 36 week combined placebo group.
530460|NCT00256204|O4|Outcome|2mg Delayed Start|2mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530461|NCT00256204|O3|Outcome|2mg Early Start|2mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530462|NCT00256204|O2|Outcome|1mg Early Start|1mg Rasagiline tablet QD early start active treatment arm (72 weeks active)
530463|NCT00256204|O1|Outcome|1mg Delayed Start|1mg Rasagiline tablet QD 36 week delayed start active treatment arms (36 weeks placebo followed by 36 weeks Rasagiline)
530464|NCT00256204|E3|Reported Event|2mg Active Treatment|2mg Active & 2mg Delayed. This group includes those patients who received 2mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 2mg Delayed start treatment arm (36 weeks active treatment)
530465|NCT00256204|E2|Reported Event|1mg Active Treatment|1mg Active & 1mg Delayed. This group includes those patients who received 1mg Rasagiline in both the early start active treatment arm (72 weeks active)and those patients who transitioned to active treatment in the 1mg Delayed start treatment arm (36 weeks active treatment)
530466|NCT00256204|E1|Reported Event|Placebo Combined Group|1mg & 2mg combined placebo group includes those patients in 1mg Delayed start and the 2mg Delayed start arms who received placebo for the first 36 weeks.
530467|NCT00255970|B3|Baseline|Total|Total of all reporting groups
530468|NCT00255970|B2|Baseline|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530469|NCT00255970|B1|Baseline|Regenafil|Regenafil graft
530470|NCT00255970|P2|Participant Flow|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530471|NCT00255970|P1|Participant Flow|Regenafil|Regenafil graft
530472|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530473|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
530474|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530475|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
530476|NCT00255970|O2|Outcome|Demineralized Freeze Dried Bone Allograft|Demineralized Freeze Dried Bone Allograft (DFDBA)
530477|NCT00255970|O1|Outcome|Regenafil|Regenafil graft
531087|NCT00252967|O1|Outcome|Placebo|
530489|NCT00255840|B2|Baseline|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530490|NCT00255840|B1|Baseline|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530491|NCT00255840|P2|Participant Flow|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530492|NCT00255840|P1|Participant Flow|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530493|NCT00255840|O2|Outcome|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530494|NCT00255840|O1|Outcome|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530495|NCT00255840|E2|Reported Event|Antiretroviral Therapy Managed by Primary Health Care Nurse|"First line antiretroviral regimen monitored by HIV-trained primary health care nurse:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530496|NCT00255840|E1|Reported Event|Antiretroviral Therapy Monitored by Medical Officer|"First line antiretroviral regimen monitored by a HIV-trained medical doctor:~Stavudine (>60 kg: 40 mg twice daily and <60 kg: 30 mg twice daily)~Lamivudine (150mg twice daily) and~Efavirenz (600mg daily). For women of child bearing potential with a CD4+ count <250 cells/mm3, Nevirapine (200 mg daily x 14 days, then 200 mg twice daily) and for women with a CD4+ count > 250 cells/mm3, Lopinavir/ritonavir (400/100mg twice daily)."
530497|NCT00255723|B3|Baseline|Total|Total of all reporting groups
530498|NCT00255723|B2|Baseline|Arm B|Augmented ICE x 2 cycles (2 risk factors)
530499|NCT00255723|B1|Baseline|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
530500|NCT00255723|P2|Participant Flow|Arm B|Augmented ICE x 2 cycles (2 risk factors)
530501|NCT00255723|P1|Participant Flow|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
530502|NCT00255723|O2|Outcome|Arm B|Augmented ICE x 2 cycles (2 risk factors)
530503|NCT00255723|O1|Outcome|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
530504|NCT00255723|E2|Reported Event|Arm B|Augmented ICE x 2 cycles (2 risk factors)
530505|NCT00255723|E1|Reported Event|Arm A|Standard dose ICE x 1 cycle, followed by augmented ICE x 1 cycle (0-1 risk factors)
530506|NCT00255684|B1|Baseline|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
530507|NCT00255684|P1|Participant Flow|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
530508|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
530509|NCT00255684|O1|Outcome|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
530510|NCT00255684|E1|Reported Event|Conditioning Therapy Followed by TBI|"Fludarabine, Cyclophosphamide; Total-Body Irradiation Followed by Cyclosporine and Mycophenolate Mofetil~graft-versus-tumor prophylaxis therapy~cyclophosphamide~cyclosporine~fludarabine phosphate~mycophenolate mofetil~umbilical cord blood transplantation~radiation therapy"
530511|NCT00255190|B3|Baseline|Total|Total of all reporting groups
530512|NCT00255190|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530513|NCT00255190|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530514|NCT00255190|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530515|NCT00255190|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530516|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530517|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530518|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530519|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530520|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530521|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530522|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530523|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530524|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530525|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530526|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530527|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530528|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530529|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530530|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530531|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530532|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530533|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530534|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530535|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530536|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530537|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530538|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530539|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530540|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530541|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530542|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530543|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530544|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530545|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530546|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530547|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530548|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530549|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530550|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530551|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530552|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530553|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530554|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530555|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530556|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530557|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530558|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530559|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530560|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530561|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530562|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530563|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530564|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530565|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530566|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530567|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530568|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530569|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530570|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530571|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530572|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530573|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530574|NCT00255190|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530575|NCT00255190|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530576|NCT00255190|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, orally, once daily for up to 12 months
530577|NCT00255190|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, orally, once daily for up to 12 months
530578|NCT00255177|B5|Baseline|Total|Total of all reporting groups
530579|NCT00255177|B4|Baseline|VGX-410 300mg Twice Daily|
530580|NCT00255177|B3|Baseline|VGX-410 300mg Daily|
530581|NCT00255177|B2|Baseline|VGX-410 150mg Daily|
530582|NCT00255177|B1|Baseline|Placebo|
530583|NCT00255177|P4|Participant Flow|VGX-410 300mg Twice Daily|
530584|NCT00255177|P3|Participant Flow|VGX-410 300mg Daily|
530585|NCT00255177|P2|Participant Flow|VGX-410 150mg Daily|
530586|NCT00255177|P1|Participant Flow|Placebo|
530587|NCT00255177|O4|Outcome|VGX-410 300mg Twice Daily|
530588|NCT00255177|O3|Outcome|VGX-410 300mg Daily|
530589|NCT00255177|O2|Outcome|VGX-410 150mg Daily|
530590|NCT00255177|O1|Outcome|Placebo|
530591|NCT00255177|E4|Reported Event|VGX-410 300mg Twice Daily|
530592|NCT00255177|E3|Reported Event|VGX-410 300mg Daily|
530593|NCT00255177|E2|Reported Event|VGX-410 150mg Daily|
530594|NCT00255177|E1|Reported Event|Placebo|
530595|NCT00255164|B4|Baseline|Total|Total of all reporting groups
530596|NCT00255164|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530597|NCT00255164|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530598|NCT00255164|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530599|NCT00255164|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530600|NCT00255164|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530601|NCT00255164|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530602|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530603|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530604|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530605|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530606|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530607|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530608|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530609|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530610|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530611|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530612|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530613|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530614|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530615|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530616|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530617|NCT00255164|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530618|NCT00255164|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530619|NCT00255164|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530620|NCT00255164|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530621|NCT00255164|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530622|NCT00255164|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530623|NCT00255151|B4|Baseline|Total|Total of all reporting groups
530624|NCT00255151|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530625|NCT00255151|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530626|NCT00255151|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530627|NCT00255151|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530628|NCT00255151|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530629|NCT00255151|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530630|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530631|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530633|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530634|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530635|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530636|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530637|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530638|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530639|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530640|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530641|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530642|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530643|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530644|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530645|NCT00255151|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530646|NCT00255151|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530647|NCT00255151|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530648|NCT00255151|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 6 months.
530649|NCT00255151|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 6 months.
530650|NCT00255151|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 6 months.
530651|NCT00255125|B3|Baseline|Total|Total of all reporting groups
530652|NCT00255125|B2|Baseline|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530653|NCT00255125|B1|Baseline|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530654|NCT00255125|P2|Participant Flow|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530655|NCT00255125|P1|Participant Flow|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530656|NCT00255125|O2|Outcome|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530657|NCT00255125|O1|Outcome|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530658|NCT00255125|E2|Reported Event|Arm Soy Supplement|"Soy Supplement~Soy Supplement: Soy protein supplement will be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530659|NCT00255125|E1|Reported Event|Arm Placebo|"Placebo~Placebo: Placebo will consist of a capsule without the soy protein added to be taken for 2-4 weeks until surgery to remove the prostate or start of radiation treatment. Patient will receive 4 capsules twice a day (8 capsules) daily to be taken with water or juice (except grapefruit juice)."
530660|NCT00255047|B5|Baseline|Total|Total of all reporting groups
530661|NCT00255047|B4|Baseline|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530662|NCT00255047|B3|Baseline|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530663|NCT00255047|B2|Baseline|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530664|NCT00255047|B1|Baseline|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530665|NCT00255047|P4|Participant Flow|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530666|NCT00255047|P3|Participant Flow|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530667|NCT00255047|P2|Participant Flow|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530668|NCT00255047|P1|Participant Flow|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530669|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530670|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530671|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
531088|NCT00252967|E2|Reported Event|Atorvastatin|
530672|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530673|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530674|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530675|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530676|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530677|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530678|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530679|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530680|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530681|NCT00255047|O4|Outcome|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530682|NCT00255047|O3|Outcome|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530683|NCT00255047|O2|Outcome|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530684|NCT00255047|O1|Outcome|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530685|NCT00255047|E4|Reported Event|Study Group 4: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530686|NCT00255047|E3|Reported Event|Study Group 3: DTaP-IPV and ActHIB®|Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
530687|NCT00255047|E2|Reported Event|Study Group 2: Pentacel®|Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
530688|NCT00255047|E1|Reported Event|Study Group 1: DAPTACEL®, IPOL®, and ActHIB®|Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
530689|NCT00255034|B3|Baseline|Total|Total of all reporting groups
530690|NCT00255034|B2|Baseline|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
530691|NCT00255034|B1|Baseline|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
530692|NCT00255034|P2|Participant Flow|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
530693|NCT00255034|P1|Participant Flow|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
530694|NCT00255034|O2|Outcome|48 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 48 weeks
530695|NCT00255034|O1|Outcome|24 Weeks of Therapy|Genotype 3 HCV subjects with high viral load (at least 2 million copies/mL) treated for 24 weeks
530696|NCT00255034|E2|Reported Event|48 Weeks of Therapy|
530697|NCT00255034|E1|Reported Event|24 Weeks of Therapy|
530698|NCT00255008|B5|Baseline|Total|Total of all reporting groups
530699|NCT00255008|B4|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530700|NCT00255008|B3|Baseline|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530701|NCT00255008|B2|Baseline|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530702|NCT00255008|B1|Baseline|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
530703|NCT00255008|P4|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530704|NCT00255008|P3|Participant Flow|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530705|NCT00255008|P2|Participant Flow|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530706|NCT00255008|P1|Participant Flow|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
530707|NCT00255008|O4|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 48 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530708|NCT00255008|O3|Outcome|Genotype 6, 7, 8, 9 SEA PEG-IFN/RIB 24 w|Genotype 6, 7, 8, 9 HCV-infected SEA subjects randomized to treatment for 24 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530709|NCT00255008|O2|Outcome|Genotype 1 Caucasian PEG-IFN/RIB 48 w|Genotype 1 HCV-infected Caucasian subjects treated for up to 48 weeks with PEG-Intron REDIPEN and REBETOL combination therapy
530710|NCT00255008|O1|Outcome|Genotype 1 SEA PEG-IFN/RIB 48 w|Genotype 1 hepatitis C virus (HCV)-infected Southeastern Asian (SEA) subjects treated for up to 48 weeks with PegIntron (peginterferon alfa-2b; PEG-IFN) REDIPEN and REBETOL (ribavirin; RIB) combination therapy
530711|NCT00255008|E4|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 48w|
530712|NCT00255008|E3|Reported Event|Genotype 6,7,8,9 SEA PEG-IFN/RIB 24w|
530716|NCT00254995|B2|Baseline|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
530717|NCT00254995|B1|Baseline|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente database was used as no study vaccine was provided or administered as part of this study."
530718|NCT00254995|P2|Participant Flow|Control Group|"Each individual receiving Menactra vaccine served as their own control for evaluation of acute (Days 0–30) events (short-term surveillance). For the 6-month (long-term) surveillance, for each person receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a received tetanus and diphtheria toxoids (Td), hepatitis A, hepatitis B, or hepatitis A/hepatitis B combination vaccine during the same month 1 year earlier.~Kaiser Permanente databases were used; Menactra and control vaccine were administered according to routine clinical practice."
530719|NCT00254995|P1|Participant Flow|Menactra Vaccine Recipients|"Kaiser Permanente members who received Menactra vaccine during the study period.~Kaiser Permanente databases were used; Menactra vaccine was administered according to routine clinical practice."
530720|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530721|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530722|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530723|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530724|NCT00254995|O2|Outcome|Control Group|The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530725|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530726|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530727|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530728|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530729|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530730|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530731|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530732|NCT00254995|O2|Outcome|Control Group|Individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.
530733|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530734|NCT00254995|O2|Outcome|Control Group|For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals.
530735|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530757|NCT00253747|O8|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 7|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530869|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, divided dose at investigator discretion.
530736|NCT00254995|O2|Outcome|Control Group|"The individuals receiving Menactra vaccine served as their own controls for evaluation of acute (Days 0–30) events. Rates of events occurring during Days 0–30 following vaccination were compared to rates of events occurring during Days 31–60 following vaccination.~The 6-month surveillance: For each individual receiving Menactra vaccine, a control matched on age (± 1 year), sex, and month of vaccination was selected who received a vaccination1 during the same month 1 year earlier. Rates of events occurring during the 6 months following vaccination with Menactra vaccine were compared to rates of events occurring during the 6 months following vaccination in the control individuals."
530737|NCT00254995|O1|Outcome|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530738|NCT00254995|E1|Reported Event|Menactra Vaccine Recipients|"Participants who received Menactra vaccine during the study period from the Kaiser Permanente databases.~None administered in this study: N/A in this study"
530739|NCT00254982|B3|Baseline|Total|Total of all reporting groups
530740|NCT00254982|B2|Baseline|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530741|NCT00254982|B1|Baseline|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530742|NCT00254982|P2|Participant Flow|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530743|NCT00254982|P1|Participant Flow|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530744|NCT00254982|O2|Outcome|Group II (Low-need)|Adult participants with moderate to severe plaque psoriasis who had undergone pretreatment with no more than one currently available systemic therapy (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530745|NCT00254982|O1|Outcome|Group 1 (High-need)|Adult participants with moderate to severe plaque psoriasis who were either not controlled by, or were intolerant to or had contraindications to at least two currently available systemic therapies (eg, photochemotherapy, cyclosporine, methotrexate, oral retinoids, fumaric acid esters, efalizumab, etanercept). Infliximab 5 mg/kg was given as an induction regimen at week 0, 2, and 6 weeks after the first infusion and then at week 14.
530746|NCT00254982|E2|Reported Event|Group 2 (Low-need)|
530747|NCT00254982|E1|Reported Event|Group 1 (High-need)|
530748|NCT00253747|B3|Baseline|Total|Total of all reporting groups
530749|NCT00253747|B2|Baseline|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
530750|NCT00253747|B1|Baseline|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
530751|NCT00253747|P2|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530752|NCT00253747|P1|Participant Flow|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530753|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530754|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530755|NCT00253747|O10|Outcome|Methylphenidate (OROS-MPH) - Placebo-Week 9|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530756|NCT00253747|O9|Outcome|Release Methylphenidate (OROS-MPH)-Week 9|OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530785|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
530870|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, divided dose at investigator discretion. Maximum daily dose of 1.8 mg/kg/day.
530758|NCT00253747|O7|Outcome|Release Methylphenidate (OROS-MPH)-Week 7|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530759|NCT00253747|O6|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 4|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530760|NCT00253747|O5|Outcome|Release Methylphenidate (OROS-MPH)-Week 4|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530761|NCT00253747|O4|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Week 11|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530762|NCT00253747|O3|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Week 11|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530763|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo-Baseline|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530764|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)-Baseline|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530765|NCT00253747|O2|Outcome|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530766|NCT00253747|O1|Outcome|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1-11. All participants received transdermal nicotine patches.
530767|NCT00253747|E2|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH) - Placebo|OROS-MPH/placebo was taken through the week 11 visit. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
530768|NCT00253747|E1|Reported Event|Osmotic-Release Methylphenidate (OROS-MPH)|For OROS-MPH, the starting dose of 18 mg/day was escalated during the first two study weeks to a maximum of 72 mg/day or to the highest dose tolerated. A trained interventionist provided each participant with a weekly 10 minute smoking cessation counseling session during study weeks 1–11. All participants received transdermal nicotine patches.
530769|NCT00253643|B5|Baseline|Total|Total of all reporting groups
530770|NCT00253643|B4|Baseline|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
530771|NCT00253643|B3|Baseline|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
530772|NCT00253643|B2|Baseline|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
530773|NCT00253643|B1|Baseline|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
530774|NCT00253643|P4|Participant Flow|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
530775|NCT00253643|P3|Participant Flow|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
530776|NCT00253643|P2|Participant Flow|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
530777|NCT00253643|P1|Participant Flow|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day~laboratory biomarker analysis: Correlative studies~questionnaire administration: Ancillary studies"
530778|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
530779|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
530780|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
530781|NCT00253643|O1|Outcome|Arm I|Fish oil, Green Tea catechin extract
530782|NCT00253643|O4|Outcome|Arm IV|Fish oil placebo, Green Tea placebo
530783|NCT00253643|O3|Outcome|Arm III|Fish oil, Green Tea placebo
530784|NCT00253643|O2|Outcome|Arm II|Fish oil placebo, Green Tea catechin extract
530786|NCT00253643|E4|Reported Event|Arm IV (Fish Oil Placebo, Green Tea Placebo)|"Patients receive an oil placebo mimicking fish oil 3/day and another placebo mimicking green tea catechins 2/day~placebo: Given olive oil placebo orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
530787|NCT00253643|E3|Reported Event|Arm III (Fish Oil, Green Tea Placebo)|"Patients receive oral fish oil 3/day and a placebo mimicking green tea catechins 2/day~fish oil: Given orally 3 times/day~placebo: Given green tea placebo orally 2 times/day"
530788|NCT00253643|E2|Reported Event|Arm II (Fish Oil Placebo, Green Tea Catechin Extract)|"Patients receive an oil placebo 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~placebo: Given olive oil placebo orally 3 times/day"
530789|NCT00253643|E1|Reported Event|Arm I (Fish Oil, Green Tea Catechin Extract)|"Patients receive oral fish oil 3/day and oral green tea extract 2/day~green tea catechin extract: Given orally 2 times/day~fish oil: Given orally 3 times/day"
530790|NCT00254592|B1|Baseline|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
530791|NCT00254592|P1|Participant Flow|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
530792|NCT00254592|O1|Outcome|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
530793|NCT00254592|E1|Reported Event|Chemotherapy With GM-CSF|Doxorubicin and Cyclophosphamide (AC) with Granulocyte-macrophage colony-stimulating factor (GM-CSF) (days 4-13) Followed by Weekly Carboplatin/Nab- Paclitaxel
530794|NCT00254566|B3|Baseline|Total|Total of all reporting groups
530795|NCT00254566|B2|Baseline|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530796|NCT00254566|B1|Baseline|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530797|NCT00254566|P2|Participant Flow|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530798|NCT00254566|P1|Participant Flow|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530799|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530800|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530801|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530802|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530803|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530804|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530805|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530806|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530807|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530808|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530809|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530810|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530811|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530812|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530813|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530814|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530815|NCT00254566|O2|Outcome|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530816|NCT00254566|O1|Outcome|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530817|NCT00254566|E2|Reported Event|Moxifloxacin|Moxifloxican (400 milligrams)were administered orally as capsules once daily for five days.
530818|NCT00254566|E1|Reported Event|Azithromycin|Azithromycin SR (2.0 grams, microspheres formulation) was administered orally as single dose in form of an oral suspension on Day 1
530819|NCT00254540|B3|Baseline|Total|Total of all reporting groups
530820|NCT00254540|B2|Baseline|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530864|NCT00254462|B3|Baseline|Total|Total of all reporting groups
530865|NCT00254462|B2|Baseline|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
530866|NCT00254462|B1|Baseline|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
530977|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530821|NCT00254540|B1|Baseline|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530822|NCT00254540|P2|Participant Flow|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530823|NCT00254540|P1|Participant Flow|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530824|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
530825|NCT00254540|O1|Outcome|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
530826|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530827|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530828|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530829|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530830|NCT00254540|O1|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530831|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530832|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530867|NCT00254462|P2|Participant Flow|Placebo|Recommended dosing of once per day, with divided dosing allowed at investigators discretion.
530868|NCT00254462|P1|Participant Flow|Atomoxetine|Recommended dosing of once per day, with divided dosing allowed at investigators discretion. Maximum dose of 1.8 mg/kg/day.
530978|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530833|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530834|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530835|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530836|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530837|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530838|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530839|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530840|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530841|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530842|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530843|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530844|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530845|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530846|NCT00254540|O2|Outcome|Pretreated Population|"SU-011248 capsule:~Subjects who had previously been treated with one cytokine-based systemic therapy regimen for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530847|NCT00254540|O1|Outcome|First-line Treatment Population|"SU-011248 capsule:~Subjects who had not had any prior systemic treatment for renal cell carcinoma. Subjects received SU-011248 in an open-label manner at a starting dose of 50-mg once daily for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. SU-011248 was taken orally in the morning without regard to meals beginning on Day 1 of the study. Subjects were monitored for toxicity, and the SU-011248 dose could be adjusted according to individual subject tolerance. Subjects were allowed to continue to receive SU-011248 until they met any of the study discontinuation criteria."
530848|NCT00254540|E1|Reported Event|Overall|SU-011248 Capsule:First-line Treatment population plus Pretreated population
530849|NCT00254501|B3|Baseline|Total|Total of all reporting groups
530850|NCT00254501|B2|Baseline|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530851|NCT00254501|B1|Baseline|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530852|NCT00254501|P2|Participant Flow|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530853|NCT00254501|P1|Participant Flow|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530854|NCT00254501|O2|Outcome|EMPOWER|Patients were scheduled for free counseling with pharmacists including medication, diet, and other self-management items. Patients also received waiver of out-of-pocket expenses for diabetes care.
530855|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530856|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530857|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530858|NCT00254501|O2|Outcome|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530859|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530860|NCT00254501|O2|Outcome|Pharmacists Consults Plus Out-of-pocket Cost Waiver|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530861|NCT00254501|O1|Outcome|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530862|NCT00254501|E2|Reported Event|EMPOWER Group|Employees received the same waiver of out-of-pocket expenses and also received up to 12 monthly visits with a pharmacist for consulting on monitoring and other educational aspects of diabetes self-management.
530863|NCT00254501|E1|Reported Event|Usual Care Plus Out-of-pocket Cost Waiver|Employees received a waiver of out-of-pocket expenses (copayments or co-insurance) for specified diabetes-related medications (including hypertensive and dyslipidemic medications) and physician visits. They also received printed educational materials at enrollment and about 3 months into the study.
530871|NCT00254462|O2|Outcome|Placebo|Recommended dosing once daily, allowed to give in divided dose at investigator discretion.
530872|NCT00254462|O1|Outcome|Atomoxetine|Recommended dosing once daily, allowed to give in divided dose at investigator discretion. Maximum dose of 1.8 mg/kg/day.
530873|NCT00254462|E2|Reported Event|Placebo|Recommended dosing once daily, divided dosing at investigator discretion.
530874|NCT00254462|E1|Reported Event|Atomoxetine|Recommended dosing once daily, divided dosing at investigator discretion. Maximum dose of 1.8 mg/kg/day.
530875|NCT00254293|B7|Baseline|Total|Total of all reporting groups
530876|NCT00254293|B6|Baseline|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants were rolled over to a variable dose of abatacept SC administered weekly following an IV loading dose of abatacept on Day 85.
530877|NCT00254293|B5|Baseline|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530878|NCT00254293|B4|Baseline|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530879|NCT00254293|B3|Baseline|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530880|NCT00254293|B2|Baseline|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530881|NCT00254293|B1|Baseline|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530882|NCT00254293|P7|Participant Flow|Fixed Dose 125 mg Abatacept|Participants who completed the variable dose long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (75, 125, 200 mg SC) were rolled over into the LTE with fixed dose, irrespective of body weight: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
530883|NCT00254293|P6|Participant Flow|Placebo|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks), by body weight. Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530884|NCT00254293|P5|Participant Flow|Group 5: 1000 mg IV/200 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo; body weight > 100 kg. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530885|NCT00254293|P4|Participant Flow|Group 4: 1000mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo; Body weight > 100 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period); variable long term for 125 mg SC: body weight <60 to >100 kg) . Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530886|NCT00254293|P3|Participant Flow|Group 3 : 750 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo (body weight 60-100 kg). Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530887|NCT00254293|P2|Participant Flow|Group 2: 500 mg IV/125 mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo;body weight < 60 kg. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Variable Long term for 125 mg SC: body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530979|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530888|NCT00254293|P1|Participant Flow|Group 1: 500 mg IV/75 mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); body weight < 60 kg. Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530889|NCT00254293|O6|Outcome|LTE (Variable and Fixed Dosing Abatacept)|Long term extension (LTE) consisted of 2 periods: variable dosing of abatacept combined with DMARDS and fixed dosing abatacept combined with DMARDS. Participants were weighed prior to starting LTE (variable dosing) and dosing was assigned per body weight category. Variable dosing period required an IV loading dose prior to starting SC dosing (if participant had been randomized to placebo in the short term period). Variable dosing: 500 mg IV/75 mg SC and 500 mg IV/125 mg SC in participants less than (<)60 kg body weight; 750 mg IV/125 mg SC in participants between 60 and 100 kg body weight; 1000 mg IV/125 mg SC and 1000 mg IV/200 mg SC in participants greater than (>) 100 kg body weight. Participants were rolled over into a fixed SC dose of 125 mg per week in the fixed dosing period prior to their Year 2 anniversary visit for the study (as early as Day 533).
530890|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
530891|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530892|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530893|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530894|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks)
530895|NCT00254293|O1|Outcome|SC Abatacept|Overall summary of all participants in the LTE. LTE Period consisted of a variable dose (75 mg, 125 mg, 200 mg abatacept) phase first and at Day 533, a fixed dose phase of 125 mg abatacept SC weekly, irrespective of body weight.
530896|NCT00254293|O1|Outcome|All Treated Participants|ECG Heart Rate change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period
530897|NCT00254293|O3|Outcome|200 mg SC Abatacept|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight >100kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530898|NCT00254293|O2|Outcome|125 mg SC Abatacept|125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Body weight <60 to >100 kg. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530899|NCT00254293|O1|Outcome|75 mg SC Abatacept|variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period); body weight <60kg. At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530900|NCT00254293|O1|Outcome|All Treated Participants|ECG change from screening after treatment were summarized for all participants treated with either abatacept or placebo in the Short Term Period.
530901|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530902|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530903|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530904|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530905|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530906|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530907|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530908|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530909|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
531089|NCT00252967|E1|Reported Event|Placebo|
530910|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530911|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530912|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530913|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530914|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530915|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530916|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530917|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530918|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530919|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530920|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530921|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530922|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530923|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530924|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530925|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530926|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks).
530927|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530928|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530929|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks).
530930|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) 12 week period: Abatacept as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks).
530931|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530932|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 200 mg SC (once weekly for 12 weeks).
530933|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an IV loading dose of abatacept on Day 1 of 1000 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
530934|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an IV loading dose of abatacept on Day 1 of 750 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
530935|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 125 mg SC (once weekly for 12 weeks).
530936|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an IV loading dose of abatacept on Day 1 of 500 mg followed by abatacept 75 mg SC (once weekly for 12 weeks).
530937|NCT00254293|O6|Outcome|Placebo (by Body Weight Category)|Subjects randomized to placebo in the ST period received IV placebo followed by SC placebo (once weekly for 12 weeks).
530938|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530980|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530981|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530939|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530940|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530941|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530942|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530943|NCT00254293|O3|Outcome|200 mg SC Abatacept (Body Weight > 100 kg)|200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (1000 mg IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530944|NCT00254293|O2|Outcome|125 mg SC Abatacept (Body Weight <60 to >100 kg)|Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530945|NCT00254293|O1|Outcome|75 mg SC Abatacept (Body Weight < 60 kg)|Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose (IV abatacept for participants randomized to placebo in ST period, loading dose 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly), or IV placebo for participants randomized to abatacept in ST period) on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period
530946|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530947|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530948|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530949|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530950|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530951|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530952|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 4 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530953|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 ((IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period). Participants from Group 3 in ST period were rolled into Group 2 for LTE variable dosing period (125 mg SC abatacept).
530982|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530954|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530955|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, IV placebo for participants randomized to abatacept in ST period).
530956|NCT00254293|O5|Outcome|Group 5: 1000 mg IV/200 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 5 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 200 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530957|NCT00254293|O4|Outcome|Group 4: 1000mg IV/125 mg SC (Body Weight > 100 kg)|Subjects randomized to abatacept in group 4 received an intravenous (IV) loading dose of abatacept on Day 1 of 1000 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530958|NCT00254293|O3|Outcome|Group 3 : 750 mg IV/125 mg SC (Body Weight 60-100 kg)|Subjects randomized to abatacept in group 3 received an intravenous (IV) loading dose of abatacept on Day 1 of 750 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530959|NCT00254293|O2|Outcome|Group 2: 500 mg IV/125 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 2 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 125 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530960|NCT00254293|O1|Outcome|Group 1: 500 mg IV/75 mg SC (Body Weight < 60 kg)|Subjects randomized to abatacept in group 1 received an intravenous (IV) loading dose of abatacept on Day 1 of 500 mg followed by 75 mg subcutaneous (SC) abatacept (once weekly for 12 weeks).
530961|NCT00254293|E7|Reported Event|Placebo (ST)|Short term (ST) randomized 12 week period: Placebo IV(Day 1)/Placebo SC (once weekly for 12 weeks). Long term extension (LTE) variable dosing period: all placebo participants rolled over to a variable dose of abatacept SC (75, 125, 200 mg) administered weekly following an IV loading dose of abatacept on Day 85. Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530962|NCT00254293|E6|Reported Event|Abatacept (LT) 125 mg SC|Participants who completed the long term extension (LTE)period and received variable doses of subcutaneous (SC) abatacept (as described in Groups 1 - 5) were rolled over into the LTE with fixed dose: SC abatacept 125 milligram (mg) in pre-filled syringes, administered Weekly.
530963|NCT00254293|E5|Reported Event|Abatacept 750mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 750 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530964|NCT00254293|E4|Reported Event|Abatacept 500mg IV/75mg SC|Short term (ST) randomized 12 week period: Abatacept or Placebo as intravenous (IV) and subcutaneous (SC) administration: Abatacept 500 mg IV (Day 1)/Abatacept 75 mg SC (once weekly for 12 weeks); Long term extension (LTE) variable dosing period: 75 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept based on their weight at screening; < 60 kg received 500 mg abatacept IV, 60 - 100 kg received 750 mg abatacept IV, > 100 kg received 1000 mg abatacept IV for participants randomized to placebo in ST period)or, IV placebo for participants randomized to abatacept in ST period). At Day 365(1-year anniversary visit), subjects were reweighed for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530965|NCT00254293|E3|Reported Event|Abatacept 500mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 500 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period; loading dose described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530966|NCT00254293|E2|Reported Event|Abatacept 1000mg IV/200mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 200 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 200 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose based on weight as described in Group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530967|NCT00254293|E1|Reported Event|Abatacept 1000mg IV/125mg SC|Short term (ST) randomized 12 week period: Abatacept 1000 mg IV (Day 1)/Abatacept 125 mg SC (once weekly for 12 weeks) or Placebo. Long term extension (LTE) variable dosing period: 125 mg abatacept SC administered weekly following an IV loading dose on Day 85 (IV abatacept for participants randomized to placebo in ST period, loading dose as described in group 1 description, or IV placebo for participants randomized to abatacept in ST period). Participants reweighed at 1 year anniversary for subsequent dosing to verify correct dosing in the variable-dose phase of the LTE period.
530968|NCT00254163|B3|Baseline|Total|Total of all reporting groups
530969|NCT00254163|B2|Baseline|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530970|NCT00254163|B1|Baseline|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530971|NCT00254163|P2|Participant Flow|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530972|NCT00254163|P1|Participant Flow|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530973|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530974|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530975|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530976|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530989|NCT00254163|O2|Outcome|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530990|NCT00254163|O1|Outcome|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530991|NCT00254163|E2|Reported Event|PCR Arm|Pentostatin, Cyclophosphamide, and Rituximab
530992|NCT00254163|E1|Reported Event|FCR Arm|Fludarabine, Cyclophosphamide, and Rituximab
530993|NCT00254072|B3|Baseline|Total|Total of all reporting groups
530994|NCT00254072|B2|Baseline|Larger Stapler|4.8 mm Circular Stapler
530995|NCT00254072|B1|Baseline|Smaller Stapler|3.5 mm Circular Stapler
530996|NCT00254072|P2|Participant Flow|Larger Stapler|4.8 mm Circular Stapler
530997|NCT00254072|P1|Participant Flow|Smaller Stapler|3.5 mm Circular Stapler
530998|NCT00254072|O2|Outcome|Larger Stapler|4.8 mm Circular Stapler
530999|NCT00254072|O1|Outcome|Smaller Stapler|3.5 mm Circular Stapler
531000|NCT00254072|E2|Reported Event|Larger Stapler|4.8 mm Circular Stapler
531001|NCT00254072|E1|Reported Event|Smaller Stapler|3.5 mm Circular Stapler
531002|NCT00253981|B3|Baseline|Total|Total of all reporting groups
531003|NCT00253981|B2|Baseline|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
531004|NCT00253981|B1|Baseline|Experimental|The experimental group received the monochromatic light infrared energy treatment (MIRE).
531005|NCT00253981|P2|Participant Flow|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
531006|NCT00253981|P1|Participant Flow|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
531007|NCT00253981|O2|Outcome|Standard of Care|Standard of care was characterized by the use of standard medical treatment to include medication.
531008|NCT00253981|O1|Outcome|Infrared Light Therapy|Intervention: The use of infrared light therapy for the treatment of tibial fracture. The treatment was assigned three times a week for four weeks.
531009|NCT00253981|E2|Reported Event|Control|The control group followed the standard of care for the treatment of shin splints, usually physical therapy and medication.
531010|NCT00253981|E1|Reported Event|Experimental|The experimental group received the monochromatic light infrared red energy treatment (MIRE).
531011|NCT00253890|B3|Baseline|Total|Total of all reporting groups
531012|NCT00253890|B2|Baseline|Placebo|1-3 at bedtime
531013|NCT00253890|B1|Baseline|Trazodone|50-150mg at bedtime
531014|NCT00253890|P2|Participant Flow|Placebo|1-3 capsules at bedtime
531015|NCT00253890|P1|Participant Flow|Trazodone|50-150mg at bedtime
531016|NCT00253890|O2|Outcome|Placebo|1-3 capsules at bedtime
531017|NCT00253890|O1|Outcome|Trazodone|50-150mg at bedtime
531018|NCT00253890|E2|Reported Event|Placebo|1-3 at bedtime
531019|NCT00253890|E1|Reported Event|Trazodone|50-150mg at bedtime
531020|NCT00253513|B1|Baseline|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531021|NCT00253513|P1|Participant Flow|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531022|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531023|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531024|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531025|NCT00253513|O1|Outcome|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531026|NCT00253513|E1|Reported Event|Treosulfan and Fludarabine Conditioning|Conditioning with Treosulfan (12 or 14 g/m2, IV for 5 days) and Fludarabine (30 mg/m2, IV for 5 days) followed by Allogeneic Hematopoietic Cell Transplantation for High-Risk Hematologic Malignancies
531027|NCT00253448|B1|Baseline|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
531028|NCT00253448|P1|Participant Flow|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
531029|NCT00253448|O1|Outcome|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
531030|NCT00253448|E1|Reported Event|Stereotactic Radiosurgery Plus Conventional Radiotherapy|Single 15-24 Gy Gamma Knife radiosurgical treatment to MR-Spectroscopy active region followed by 60 Gy of conventionally fractionated radiotherapy (2.0 Gy will be given daily 5 days per week for a total of 60.0 Gy)
531031|NCT00253435|B3|Baseline|Total|Total of all reporting groups
531032|NCT00253435|B2|Baseline|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531033|NCT00253435|B1|Baseline|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531034|NCT00253435|P2|Participant Flow|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531090|NCT00252733|B3|Baseline|Total|Total of all reporting groups
531035|NCT00253435|P1|Participant Flow|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531036|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531037|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531038|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531039|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531040|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531041|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531042|NCT00253435|O2|Outcome|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531043|NCT00253435|O1|Outcome|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531044|NCT00253435|E2|Reported Event|Good Risk Patients|Good risk patients are those who experienced a Partial Response (PR) following 4 cycles of induction.
531045|NCT00253435|E1|Reported Event|Poor Risk Patients|Poor risk patients are those who experienced a Minor response (MR) or No Response (NR) to induction therapy or progressive disease (PD) during or following induction.
531046|NCT00253370|B1|Baseline|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531047|NCT00253370|P1|Participant Flow|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 400 mg twice daily on days 1-21. Patients also receive docetaxel IV, 75mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531048|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531049|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531050|NCT00253370|O1|Outcome|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV, 75 mg/m2 over 1 hour and cisplatin IV, 75 mg/m2 over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531051|NCT00253370|E1|Reported Event|BAY 43-9006, Docetaxel, Cisplatin|"Patients receive oral BAY 43-9006 twice daily on days 1-21. Patients also receive docetaxel IV over 1 hour and cisplatin IV over 1-2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~BAY 43-9006: Given orally~docetaxel: Given IV~cisplatin: Given IV"
531052|NCT00253019|B4|Baseline|Total|Total of all reporting groups
531053|NCT00253019|B3|Baseline|Ortho Evra|Participants self-selected to receive Ortho Evra.
531054|NCT00253019|B2|Baseline|Depo Provera|Participants self-selected to receive Depo Provera
531055|NCT00253019|B1|Baseline|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
531056|NCT00253019|P3|Participant Flow|Ortho Evra|Participants self-selected to receive Ortho Evra.
531057|NCT00253019|P2|Participant Flow|Depo Provera|Participants self-selected to receive Depo Provera
531058|NCT00253019|P1|Participant Flow|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
531059|NCT00253019|O3|Outcome|Ortho Evra|Participants self-selected to receive Ortho Evra.
531060|NCT00253019|O2|Outcome|Depo Provera|Participants self-selected to receive Depo Provera
531061|NCT00253019|O1|Outcome|Oral Contraceptive|Participants self-selected to receive oral contraceptives.
531062|NCT00253019|E3|Reported Event|Ortho Evra|participants self-selected to receive ortho evra
531063|NCT00253019|E2|Reported Event|Depo Provera|Participants self-selected to use depo provera
531064|NCT00253019|E1|Reported Event|Oral Contraceptives|participants self-selected to take oral contraceptives
531065|NCT00252967|B3|Baseline|Total|Total of all reporting groups
531066|NCT00252967|B2|Baseline|Atorvastatin|
531067|NCT00252967|B1|Baseline|Placebo|
531068|NCT00252967|P2|Participant Flow|Atorvastatin|
531069|NCT00252967|P1|Participant Flow|Placebo|
531070|NCT00252967|O2|Outcome|Atorvastatin|
531071|NCT00252967|O1|Outcome|Placebo|
531072|NCT00252967|O2|Outcome|Atorvastatin|
531073|NCT00252967|O1|Outcome|Placebo|
531074|NCT00252967|O2|Outcome|Atorvastatin|
531075|NCT00252967|O1|Outcome|Placebo|
531076|NCT00252967|O2|Outcome|Atorvastatin|
531077|NCT00252967|O1|Outcome|Placebo|
531078|NCT00252967|O2|Outcome|Atorvastatin|
531079|NCT00252967|O1|Outcome|Placebo|
531080|NCT00252967|O2|Outcome|Atorvastatin|
531081|NCT00252967|O1|Outcome|Placebo|
531082|NCT00252967|O2|Outcome|Atorvastatin|
531083|NCT00252967|O1|Outcome|Placebo|
531084|NCT00252967|O2|Outcome|Atorvastatin|
531092|NCT00252733|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
531093|NCT00252733|P2|Participant Flow|Placebo|Placebo Comparator
531094|NCT00252733|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
531095|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
531096|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531097|NCT00252733|O2|Outcome|Placebo|Placebo Comparator
531098|NCT00252733|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531099|NCT00252733|E2|Reported Event|Placebo|Placebo Comparator
531100|NCT00252733|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
531101|NCT00252720|B3|Baseline|Total|Total of all reporting groups
531102|NCT00252720|B2|Baseline|Placebo|Placebo Comparator
531103|NCT00252720|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
531104|NCT00252720|P2|Participant Flow|Placebo|Placebo Comparator
531105|NCT00252720|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
531106|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
531107|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531108|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
531109|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531110|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
531111|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531112|NCT00252720|O2|Outcome|Placebo|Placebo Comparator
531113|NCT00252720|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531114|NCT00252720|E2|Reported Event|Placebo|Placebo Comparator
531115|NCT00252720|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
531116|NCT00252694|B3|Baseline|Total|Total of all reporting groups
531117|NCT00252694|B2|Baseline|Placebo|Placebo Comparator
531118|NCT00252694|B1|Baseline|Candesartan|Candesartan cilexetil 32 mg once daily
531119|NCT00252694|P2|Participant Flow|Placebo|Placebo Comparator
531120|NCT00252694|P1|Participant Flow|Candesartan|Candesartan cilexetil 32 mg once daily
531121|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
531122|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531123|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
531124|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531125|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
531126|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531127|NCT00252694|O2|Outcome|Placebo|Placebo Comparator
531128|NCT00252694|O1|Outcome|Candesartan|Candesartan cilexetil 32 mg once daily
531129|NCT00252694|E2|Reported Event|Placebo|Placebo Comparator
531130|NCT00252694|E1|Reported Event|Candesartan|Candesartan cilexetil 32 mg once daily
531131|NCT00252629|B4|Baseline|Total|Total of all reporting groups
531132|NCT00252629|B3|Baseline|Healthy Asymptomatic Control|"Eleven male veterans of first gulf war were screened for fatigue, pain and cognitive dysfunction by self report instrument.~They all score below the clinical thershold and assigned as healthy asymptomatic"
531133|NCT00252629|B2|Baseline|Sham Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
531134|NCT00252629|B1|Baseline|Therapeutic Nasal CPAP|The occurrence of the following 3 symptoms in a Gulf War veteran beginning after 8/90, lasting at least 6 months and present at the time of screening: fatigue that limits usual activity; musculoskeletal pain involving 2 or more regions of the body; and cognitive symptoms (memory, concentration, or attention difficulties). All 3 symptoms must be unexplained by any clearly defined organic illness.
531135|NCT00252629|P3|Participant Flow|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 18 male veterans with GWS (same group that were randomized to receive CPAP treatment) and 11 asymptomatic male veterans of the first Gulf war.~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
531136|NCT00252629|P2|Participant Flow|Sham Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with sham nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on sham nasal CPAP."
531137|NCT00252629|P1|Participant Flow|Therapeutic Nasal CPAP|"Nine participants assigned to receive 3 weeks of treatment during sleep with therapeutic nasal CPAP.~Using validated questionnaires, fatigue, pain, and cognitive dysfunction were assessed by self-report before and after the three weeks treatment trial.~We compared the change of veterans reported outcomes symptoms change before and after 3 weeks treatment period on therapeutic nasal CPAP."
531138|NCT00252629|O2|Outcome|Asymptomatic Male Veterans of Gulf War.|"A group of 11 asymptomatic male veterans of gulf war were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
531170|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531230|NCT00252239|P2|Participant Flow|TNK 0.25 mg/kg|Medium dose tenecteplase
531231|NCT00252239|P1|Participant Flow|TNK 0.1 mg/kg|Lowest dose tenecteplase
531139|NCT00252629|O1|Outcome|GWS Male Group|"A group of18 male veterans with GWS were examined. Each participant underwent full night polysomnogram while sleeping supine using a standard clinical monitoring for sleep and breathing. Inspiratory flow was measured using pneumotachograph and respiratory effort measured with supra-glottis catheter.~Sampling of flow and effort during continuous stage 2 sleep was obtained and compared among both groups.~Inspiratory flow was plotted against effort for each breath. IFL was defined as a 1 cm H2O or greater decrease in supraglotic pressure without a corresponding increase in airflow of at least 5 ml/second.~The percentage of flow limited breath was calculated as the total number of flow limited breaths divided by the total breaths in all the samples."
531140|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment on sham nasal CPAP
531141|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of cognitive dysfunction ( increasing difficulty with memory, ability to think, and ability to concentrate) complaints before and after 3 weeks treatment of therapeutic nasal CPAP
531142|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of pain complaint before and after treatment of 3 weeks on sham nasal CPAP
531143|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of pain complaint before and after 3 weeks treatment of therapeutic nasal CPAP
531144|NCT00252629|O2|Outcome|Sham Nasal CPAP|Comparing the change of fatigue complaint before and after treatment of 3 weeks on sham nasal CPAP
531145|NCT00252629|O1|Outcome|Therapeutic Nasal CPAP|Comparing the change of fatigue complaint before and after 3 weeks treatment of therapeutic nasal CPAP
531146|NCT00252629|E3|Reported Event|Comparison of IFL During Sleep in GWS and Healthy|"We recruited 11 asymptomatic male veterans of the first Gulf war. In addition to our 18 male veterans with GWS (same group that were randomized to receive CPAP treatment).~All veterans had a polysomnography to determine the presence of sleep disordered breathing.~We compared the prevalence of Inspiratory Flow Limitation (IFL) during supine stage 2 sleep among both groups."
531147|NCT00252629|E2|Reported Event|Sham Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on sham nasal CPAP with change of symptoms on therapeutic nasal CPAP
531148|NCT00252629|E1|Reported Event|Therapeutic Nasal CPAP|Comparing change of veterans reported outcomes ( fatigue, pain and cognitive dysfunction) before and after 3 weeks treatment on therapeutic nasal CPAP with change of symptoms on sham nasal CPAP
531149|NCT00252590|B4|Baseline|Total|Total of all reporting groups
531150|NCT00252590|B3|Baseline|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
531151|NCT00252590|B2|Baseline|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
531152|NCT00252590|B1|Baseline|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
531153|NCT00252590|P3|Participant Flow|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
531154|NCT00252590|P2|Participant Flow|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use provided in four once monthly 45-minute sessions. Topics for sessions include sleep, pain, cardiovascular health, and gastrointestinal health."
531155|NCT00252590|P1|Participant Flow|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status provided in four once monthly 45 minute sessions. Information for feedback was attained with assessments and blood serum testing."
531156|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
531157|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
531158|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
531159|NCT00252590|O3|Outcome|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
531160|NCT00252590|O2|Outcome|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
531161|NCT00252590|O1|Outcome|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
531162|NCT00252590|E3|Reported Event|Control - Treatment as Usual|"No added treatment control~Control - treatment as usual: Control group with no additional intervention"
531163|NCT00252590|E2|Reported Event|Health Education|"Non-personalized didactic health-related education~Health Education: Generalized health education related to alcohol use"
531164|NCT00252590|E1|Reported Event|Health Motivational Feedback|"Personalized health-related feedback~Health Motivational Feedback: Personalized feedback on health status"
531165|NCT00252564|B3|Baseline|Total|Total of all reporting groups
531166|NCT00252564|B2|Baseline|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531167|NCT00252564|B1|Baseline|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531168|NCT00252564|P2|Participant Flow|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531169|NCT00252564|P1|Participant Flow|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531227|NCT00252239|B1|Baseline|TNK 0.1 mg/kg|Lowest dose tenecteplase
531171|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531172|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531173|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531174|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531175|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531176|NCT00252564|O2|Outcome|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531177|NCT00252564|O1|Outcome|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531178|NCT00252564|E2|Reported Event|Arm B|"(FOLF-CB): Cetuximab administered over 2 hours (first dose only; administer all other doses over 1 hour) followed by bevacizumab over 30 minutes, followed by LV over 30 minutes, followed by bolus 5-FU followed by infusional 5-FU.~Cetuximab --> bevacizumab --> LV --> bolus 5-FU --> infusional 5-FU"
531179|NCT00252564|E1|Reported Event|Arm A|"(Bev-FOLFOX): Bevacizumab, followed by oxaliplatin and LV given simultaneously via “T” connector over 2 hours, followed by bolus 5-FU followed by infusional 5-FU.~Bevacizumab --> oxaliplatin and LV --> bolus 5-FU --> infusional 5-FU~Dosing on Days 1 and 15 of each 28-day cycle"
531180|NCT00252538|B1|Baseline|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
531181|NCT00252538|P2|Participant Flow|Group 2 Non MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
531182|NCT00252538|P1|Participant Flow|Group 1 MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus (HCV), 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
531183|NCT00252538|O2|Outcome|Group 2- no MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
531184|NCT00252538|O1|Outcome|Group 1- MDD|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~This is an observational study that segregates patients who have HCV and are started on interferon alpha treatment into 2 groups based on whether they develop major depressive disorder (MDD) while on interferon alpha therapy for HCV and then examines genes that may confer risk for MDD development. group 1 MDD and group 2 no MDD"
531185|NCT00252538|E1|Reported Event|Group 1|"Research participants are: 1) male or female, 2) age 18 or older, 3) chronically infected with the hepatitis C virus, 4) candidates for interferon therapy, 4) not on antidepressant treatment , and 5) not currently abusing any substances such as alcohol or intravenous drugs, or having abused in the past 6 months~interferon-alpha: This is an observational study only. The patients are on interferon alpha therapy for HCV, but prescribing interferon is not a part of this research study protocol."
531186|NCT00252512|B3|Baseline|Total|Total of all reporting groups
531187|NCT00252512|B2|Baseline|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
531228|NCT00252239|P4|Participant Flow|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
531229|NCT00252239|P3|Participant Flow|TNK 0.4 mg/kg|Highest dose tenecteplase
531188|NCT00252512|B1|Baseline|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
531189|NCT00252512|P2|Participant Flow|Placebo|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
531190|NCT00252512|P1|Participant Flow|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
531191|NCT00252512|O2|Outcome|Arm 2|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
531192|NCT00252512|O1|Outcome|Arm 1|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
531193|NCT00252512|E2|Reported Event|Baseline|"Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results.~Placebo: Participants complete urine and breath screens 2 times per week for 8 weeks with no reinforcement for negative results."
531194|NCT00252512|E1|Reported Event|Contingency Management|"Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are negative, they receive a chance to draw tokens from a bowl. Some tokens are social reinforcement. Others have monetary value ($1, $20 or $80 canteen voucher).~Contingency Management: Participants complete urine and breath screens 2 times per week for 8 weeks. If urine and breath screens are both negative, the participant receives a chance to draw tokens from a bowl. Some tokens are social reinforcement (Good Job!). Other have monetary value ($1, $20, or $80 canteen voucher)."
531195|NCT00252499|B4|Baseline|Total|Total of all reporting groups
531196|NCT00252499|B3|Baseline|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531197|NCT00252499|B2|Baseline|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531198|NCT00252499|B1|Baseline|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531199|NCT00252499|P3|Participant Flow|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531200|NCT00252499|P2|Participant Flow|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531201|NCT00252499|P1|Participant Flow|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531202|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531203|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531204|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531205|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531206|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531207|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531208|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531209|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531210|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531211|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531212|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531213|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531214|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531215|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531216|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531217|NCT00252499|O3|Outcome|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531218|NCT00252499|O2|Outcome|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531219|NCT00252499|O1|Outcome|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531220|NCT00252499|E3|Reported Event|Arm 3|micronized fenofibrate 200 mg 1 po qd and rosiglitazone placebo 1 po bid
531221|NCT00252499|E2|Reported Event|Arm 2|rosiglitazone 4 mg po bid and fenofibrate placebo 1 po qd
531222|NCT00252499|E1|Reported Event|Arm 1|matching placebo for rosiglitazone, 1 po bid and placebo for fenofibrate 1 po qd
531223|NCT00252239|B5|Baseline|Total|Total of all reporting groups
531224|NCT00252239|B4|Baseline|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
531225|NCT00252239|B3|Baseline|TNK 0.4 mg/kg|Highest dose tenecteplase
531226|NCT00252239|B2|Baseline|TNK 0.25 mg/kg|Medium dose tenecteplase
531232|NCT00252239|O4|Outcome|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
531233|NCT00252239|O3|Outcome|TNK 0.4 mg/kg|Highest dose tenecteplase
531234|NCT00252239|O2|Outcome|TNK 0.25 mg/kg|Medium dose tenecteplase
531235|NCT00252239|O1|Outcome|TNK 0.1 mg/kg|Lowest dose tenecteplase
531236|NCT00252239|E4|Reported Event|tPA 0.9 mg/kg|"tissue plasminogen activator, tPA~tissue plasminogen activator, tPA: To date, tissue plasminogen activator (tPA) is the only scientifically-proven and FDA-approved treatment for acute stroke."
531237|NCT00252239|E3|Reported Event|TNK 0.4 mg/kg|Highest dose tenecteplase
531238|NCT00252239|E2|Reported Event|TNK 0.25 mg/kg|Medium dose tenecteplase
531239|NCT00252239|E1|Reported Event|TNK 0.1 mg/kg|Lowest dose tenecteplase
531240|NCT00252187|B3|Baseline|Total|Total of all reporting groups
531241|NCT00252187|B2|Baseline|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531242|NCT00252187|B1|Baseline|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531243|NCT00252187|P2|Participant Flow|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531244|NCT00252187|P1|Participant Flow|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531245|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531246|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531247|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531248|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531249|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531250|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531251|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531252|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531253|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531254|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531255|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531256|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531257|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531258|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531259|NCT00252187|O2|Outcome|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks.
531260|NCT00252187|O1|Outcome|B-type Natriuretic Peptide (BNP)|BNP (nesiritide) hormone self-administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531261|NCT00252187|E2|Reported Event|Placebo|Placebo self-administered subcutaneously twice daily for 8 weeks
531262|NCT00252187|E1|Reported Event|BPN Group|BNP (nesiritide) administered subcutaneously twice daily for 8 weeks at 10 mcg/kg.
531263|NCT00252057|B3|Baseline|Total|Total of all reporting groups
531264|NCT00252057|B2|Baseline|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
531265|NCT00252057|B1|Baseline|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
531266|NCT00252057|P2|Participant Flow|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
531267|NCT00252057|P1|Participant Flow|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
531268|NCT00252057|O2|Outcome|Standard Hospital Discharge|Participants received the routine, standard hospital discharge.
531269|NCT00252057|O1|Outcome|Re-engineered Hospital Discharge|"Participants received the Re-Engineered Hospital Discharge, a set of 11 discrete, mutually reinforcing components provided by a Discharge Advocate and re-enforced by a telephone call 2-4 days after discharge by a clinical pharmacist."
531270|NCT00251979|B3|Baseline|Total|Total of all reporting groups
531271|NCT00251979|B2|Baseline|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531272|NCT00251979|B1|Baseline|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531273|NCT00251979|P2|Participant Flow|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531274|NCT00251979|P1|Participant Flow|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531275|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531276|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531277|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531278|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531279|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531280|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531281|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531282|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531283|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531284|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531285|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531286|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531287|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531288|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531289|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531290|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531291|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531292|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531293|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531294|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531295|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531296|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531297|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531298|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531299|NCT00251979|O2|Outcome|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531300|NCT00251979|O1|Outcome|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531301|NCT00251979|E2|Reported Event|Placebo|Placebo iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531302|NCT00251979|E1|Reported Event|Esomeprazole|Esomeprazole iv for 72 h followed by esomeprazole oral 40 mg od for 27 days
531303|NCT00251927|B3|Baseline|Total|Total of all reporting groups
531304|NCT00251927|B2|Baseline|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531305|NCT00251927|B1|Baseline|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531306|NCT00251927|P2|Participant Flow|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531307|NCT00251927|P1|Participant Flow|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531308|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531309|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531310|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531311|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531312|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531313|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531314|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531315|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531316|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531317|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531318|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531319|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531320|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531321|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531322|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531323|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531324|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531325|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531326|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531327|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531328|NCT00251927|O2|Outcome|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531329|NCT00251927|O1|Outcome|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531330|NCT00251927|E3|Reported Event|Non-Surgical Arm|This group of patients was randomized to receive surgery but were on operated on and were followed for safety purposes
531331|NCT00251927|E2|Reported Event|Esomeprazole Medical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by esomeprazole treatment (start dose 20 mg once daily, if needed adjusted to 40 mg once daily)
531332|NCT00251927|E1|Reported Event|Esomeprazole Surgical Arm|Esomeprazole 40 mg once daily during a 12-week run-in period, followed by laparoscopic anti-reflux fundoplication anti-reflux surgery.
531333|NCT00251862|B4|Baseline|Total|Total of all reporting groups
531334|NCT00251862|B3|Baseline|Control|Standard Care
531335|NCT00251862|B2|Baseline|DA Alone|Decision aid alone
531336|NCT00251862|B1|Baseline|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531337|NCT00251862|P3|Participant Flow|Control|Standard Care
531338|NCT00251862|P2|Participant Flow|DA Alone|Decision aid alone
531339|NCT00251862|P1|Participant Flow|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531340|NCT00251862|O3|Outcome|Control|Standard Care
531341|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
531342|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531343|NCT00251862|O3|Outcome|Control|Standard Care
531344|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
531345|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531346|NCT00251862|O3|Outcome|Control|Standard Care
531347|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
531348|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531349|NCT00251862|O3|Outcome|Control|Standard Care
531350|NCT00251862|O2|Outcome|DA Alone|Decision aid alone
531351|NCT00251862|O1|Outcome|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531352|NCT00251862|E3|Reported Event|Control|Standard Care
531353|NCT00251862|E2|Reported Event|DA Alone|Decision aid alone
531354|NCT00251862|E1|Reported Event|DA + YDR|Decision aid (DA) plus Your Disease Risk (YDR) personalized risk feedback
531355|NCT00251004|B4|Baseline|Total|Total of all reporting groups
531356|NCT00251004|B3|Baseline|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531357|NCT00251004|B2|Baseline|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531358|NCT00251004|B1|Baseline|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531359|NCT00251004|P3|Participant Flow|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531360|NCT00251004|P2|Participant Flow|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531420|NCT00251745|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531421|NCT00251745|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531422|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531645|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531361|NCT00251004|P1|Participant Flow|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531362|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531363|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531364|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531365|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531366|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531367|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531368|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531369|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531370|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531371|NCT00251004|O3|Outcome|Control Group|"1.44 g Mycophenolic Acid (MPA) (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531372|NCT00251004|O2|Outcome|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531373|NCT00251004|O1|Outcome|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531374|NCT00251004|E3|Reported Event|Control Group|"1.44 g Mycophenolic Acid (two 360-mg tablets bid) + basiliximab + standard-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a C0 value within the following range for the time of the study: starting at the day 5 visit: 200-300 ng/mL, starting at the month 2 visit and thereafter: 100-250 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531375|NCT00251004|E2|Reported Event|High-dose Everolimus Group|"3.0 mg everolimus (two 0.75-mg tablets bid) + basiliximab + reduced-dose CsA ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531376|NCT00251004|E1|Reported Event|Low-dose Everolimus Group|"1.5 mg everolimus (one 0.75-mg tablet bis in diem/twice a day (bid)) + basiliximab + reduced-dose Cyclosporine A (CsA) ± corticosteroids.~The CsA dose was adjusted to attain a trough (C0) value within the pre-specified target ranges: starting at the day 5 visit: 100-200 ng/mL, starting at the month 2 visit: 75-150 ng/mL, starting at the month 4 visit: 50-100 ng/mL and starting at the month 6 visit: 25-50 ng/mL. Patients received their first dose of basiliximab within 2 hours prior to transplant surgery and on day 4 post-transplant or according to local practice. Corticosteroids were administered according to local therapy."
531377|NCT00250926|B1|Baseline|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
531378|NCT00250926|P1|Participant Flow|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
531379|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
531380|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|"A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.~Bortezomib: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Dexamethasone: Given intravenously on days 1, 4, 8, and 11 of a 21-day cycle for 8 cycles~Rituximab: Given intravenously after bortezomib and dexamethasone on day 11 of a 21-day cycle for 8 cycles"
531381|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
531382|NCT00250926|O1|Outcome|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
531383|NCT00250926|E1|Reported Event|Bortezomib, Dexamethasone, Rituximab|A cycle of therapy consisted of bortezomib 1.3 mg/m(2) intravenously; dexamethasone 40 mg on days 1, 4, 8, and 11; and rituximab 375 mg/m(2) on day 11. Patients received four consecutive cycles for induction therapy and then four more cycles, each given 3 months apart, for maintenance therapy.
531384|NCT00250835|B1|Baseline|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531385|NCT00250835|P1|Participant Flow|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531386|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531387|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531388|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531389|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531390|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531391|NCT00250835|O1|Outcome|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531392|NCT00250835|E1|Reported Event|Chemotherapy, Celecoxib, and Radiation|"Oxaliplatin weekly at 50 mg/m2 given intravenously over two hours for the duration of radiation.~Capecitabine: on the days of radiation at 850 mg/m2 orally twice a day [1700 mg/m2/day] (Monday through Friday during radiation therapy).~Celecoxib at 200 mg orally twice a day throughout the duration of radiation without a break.~Chemotherapy, Celecoxib, and Radiation: Enrolled rectal cancer patients are treated with concurrent chemoradiation and celecoxib pre-operatively for at least 14 days. Definitive surgery is performed within 6 weeks from the end of treatment."
531393|NCT00251758|B4|Baseline|Total|Total of all reporting groups
531394|NCT00251758|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531395|NCT00251758|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531396|NCT00251758|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531397|NCT00251758|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531398|NCT00251758|P2|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531399|NCT00251758|P1|Participant Flow|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531400|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531401|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531402|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531403|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531404|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531405|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531406|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531407|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531408|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531409|NCT00251758|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531410|NCT00251758|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531411|NCT00251758|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531412|NCT00251758|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531413|NCT00251758|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531414|NCT00251758|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531415|NCT00251745|B4|Baseline|Total|Total of all reporting groups
531416|NCT00251745|B3|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531417|NCT00251745|B2|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531418|NCT00251745|B1|Baseline|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531419|NCT00251745|P3|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531592|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531423|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531424|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531425|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531426|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531427|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531428|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531429|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531430|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531431|NCT00251745|O3|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531432|NCT00251745|O2|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531433|NCT00251745|O1|Outcome|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531434|NCT00251745|E3|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 4 weeks.
531435|NCT00251745|E2|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 4 weeks.
531436|NCT00251745|E1|Reported Event|Placebo QD|Placebo capsules, orally, once daily for up to 4 weeks.
531437|NCT00251719|B4|Baseline|Total|Total of all reporting groups
531438|NCT00251719|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531439|NCT00251719|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531440|NCT00251719|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531441|NCT00251719|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531442|NCT00251719|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531443|NCT00251719|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531444|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531445|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531446|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531447|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531448|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531449|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531450|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531451|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531452|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531453|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531454|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531455|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531456|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531457|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531458|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531459|NCT00251719|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531460|NCT00251719|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531461|NCT00251719|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531462|NCT00251719|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531463|NCT00251719|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531464|NCT00251719|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531465|NCT00251693|B4|Baseline|Total|Total of all reporting groups
531466|NCT00251693|B3|Baseline|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531467|NCT00251693|B2|Baseline|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531468|NCT00251693|B1|Baseline|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531469|NCT00251693|P3|Participant Flow|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531470|NCT00251693|P2|Participant Flow|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531471|NCT00251693|P1|Participant Flow|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531472|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531473|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531474|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531593|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531475|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531476|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531477|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531478|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531479|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531480|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531481|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531482|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531483|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531484|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531485|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531486|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531487|NCT00251693|O3|Outcome|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531488|NCT00251693|O2|Outcome|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531489|NCT00251693|O1|Outcome|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531490|NCT00251693|E3|Reported Event|Lansoprazole 30 mg QD|Lansoprazole 30 mg, capsules, orally, once daily for up to 8 weeks.
531491|NCT00251693|E2|Reported Event|Dexlansoprazole MR 90 mg QD|Dexlansoprazole MR 90 mg, capsules, orally, once daily for up to 8 weeks.
531492|NCT00251693|E1|Reported Event|Dexlansoprazole MR 60 mg QD|Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 8 weeks.
531493|NCT00251641|B3|Baseline|Total|Total of all reporting groups
531494|NCT00251641|B2|Baseline|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531495|NCT00251641|B1|Baseline|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531496|NCT00251641|P2|Participant Flow|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531497|NCT00251641|P1|Participant Flow|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531498|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531499|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531500|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531501|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531502|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531503|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531504|NCT00251641|O2|Outcome|Methotrexate|Methotrexate (MTX) will be supplied as 2.5 mg tablets. Subjects are to take 15 mg/week orally for the first 6 weeks of the study. Subjects will be advised to take their MTX as a single dose (weekly) on the same day of the week. If subjects randomized to MTX 15 mg/week experience a <25% reduction in PASI score at Week 6 (Visit 4) as compared with Baseline, their MTX dose will be increased to 20 mg/week. Subjects will be treated for 22 weeks.
531505|NCT00251641|O1|Outcome|Infliximab|The infliximab dose will be prepared according to the subject's weight (5 mg/kg). Each intravenous (IV) infusion will be administered over a period of not less than 2 hours. The infusion must be given via a separate line using the administration set with a 1.2 micron filter. Subjects will be infused at Weeks 0, 2, 6, 14, and 22.
531506|NCT00251641|E4|Reported Event|Participants Who Switched From Methotrexate to Infliximab|Adverse events reported for participants who switched from methotrexate to infliximab at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
531507|NCT00251641|E3|Reported Event|Participants Who Switched From Infliximab to Methotrexate|Adverse events reported for participants who switched from infliximab to methotrexate at Week 16 (including only adverse events with begin dates on or after a switch in treatment).
531508|NCT00251641|E2|Reported Event|Methotrexate|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
531509|NCT00251641|E1|Reported Event|Infliximab|Adverse events reported through Week 26 for participants who did not switch treatment at Week 16 and adverse reported through Week 16 for those participants who switched treatment.
531510|NCT00251589|B5|Baseline|Total|Total of all reporting groups
531511|NCT00251589|B4|Baseline|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531512|NCT00251589|B3|Baseline|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531513|NCT00251589|B2|Baseline|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531514|NCT00251589|B1|Baseline|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531515|NCT00251589|P4|Participant Flow|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531516|NCT00251589|P3|Participant Flow|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531517|NCT00251589|P2|Participant Flow|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531518|NCT00251589|P1|Participant Flow|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531519|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531520|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531521|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531522|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531523|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531524|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531525|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531594|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531526|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531527|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531528|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531529|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531530|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531531|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531532|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531533|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531534|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531535|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531536|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531537|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531538|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531539|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531540|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531541|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531542|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531543|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531544|NCT00251589|O4|Outcome|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531545|NCT00251589|O3|Outcome|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531546|NCT00251589|O2|Outcome|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531547|NCT00251589|O1|Outcome|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531548|NCT00251589|E4|Reported Event|Vorinostat 400 mg q.d. 21d/4wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 400 mg once a day for 21 out of 28 days + erlotinib 150 mg once a day was evaluated in the Phase I portion of the original study and exceeded MTD. This cohort was then amended (Amendment 1) to identify a more tolerable once daily vorinostat dosing regimen. All patients treated at this dose level were assigned to the Phase I portion of the study.
531549|NCT00251589|E3|Reported Event|Vorinostat 300 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531550|NCT00251589|E2|Reported Event|Vorinostat 300 mg q.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 300 mg once a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the amended study and exceeded the MTD. All patients treated at this dose level were assigned to the Phase I portion of the study.
531551|NCT00251589|E1|Reported Event|Vorinostat 200 mg b.i.d. 3d/wk + Erlotinib 150 mg q.d. 7d/wk|Vorinostat 200 mg twice a day for 3 days a week + erlotinib 150 mg once a day was evaluated in the Phase I portion of the study and determined to be the MTD and therefore the recommended Phase II dose. Of the 16 patients treated at this dose level, 4 were assigned to the Phase I portion of the study and 12 were assigned to the Phase II portion.
531552|NCT00251316|B3|Baseline|Total|Total of all reporting groups
531553|NCT00251316|B2|Baseline|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
531554|NCT00251316|B1|Baseline|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
531555|NCT00251316|P2|Participant Flow|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
531556|NCT00251316|P1|Participant Flow|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
531557|NCT00251316|O2|Outcome|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
531558|NCT00251316|O1|Outcome|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
531559|NCT00251316|E2|Reported Event|Placebo|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive placebo (look-alike capsules with no active ingredient).
531560|NCT00251316|E1|Reported Event|Lithium Carbonate|Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Participants in this arm receive lithium capsules.
531561|NCT00251303|B3|Baseline|Total|Total of all reporting groups
531562|NCT00251303|B2|Baseline|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
531563|NCT00251303|B1|Baseline|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
531564|NCT00251303|P2|Participant Flow|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
531565|NCT00251303|P1|Participant Flow|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
531595|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531566|NCT00251303|O2|Outcome|Placebo|Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms.
531567|NCT00251303|O1|Outcome|Riluzole|Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day.
531568|NCT00251303|O2|Outcome|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
531569|NCT00251303|O1|Outcome|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
531570|NCT00251303|E2|Reported Event|Placebo|"Placebo capsules were prepared by NIH Clinical Center Pharmacy to appear identical to active drug capsules. Dose was titrated upward as if active drug. Follow-up and laboratory studies were identical for active drug and placebo arms. At the end of the double-blind phase, subjects could elect to take open-label drug, which was titrated upward to the maximum dose, 100 mg daily.~Study blind was not broken for subjects or investigators until the final subject had completed the double-blind phase of the study."
531571|NCT00251303|E1|Reported Event|Riluzole|"In a 12-weeks long double-blind phase, the clinicians and subjects and their guardians were blind to active drug or placebo. There were approx. twice monthly in-person or telephone contacts.~Riluzole was titrated upward to at least 100 mg of active drug. If adverse effects are noted, dose titration was slowed, stopped, or reversed, or the drug was discontinued. Maximum permitted dose of riluzole was 120 mg/day. At the end of the 12 weeks study period, subjects and their families could elect to take open-label riluzole.Since neither subjects nor investigators knew whether subjects had been receiving active drug,the open-label administration was also titrated. Laboratory assays were obtained at 2, 4, 8, and 12 weeks after starting the open-label riluzole, as they had been during double-blind. Subsequently, testing was less frequent."
531572|NCT00250718|B1|Baseline|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
531573|NCT00250718|P1|Participant Flow|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
531574|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
531575|NCT00250718|O1|Outcome|Arm 1 Combination Treatment|"VP-16 at 50 mg/day, orally for 14 days every 28 days; Chlorambucil at 0.1 mg/kg/day orally for 14 days every 28 days; Vincristine at 2 mg intravenously every 14 days; Dexamethasone at 200 mg intravenously every 24 days; Rituxan (rituximab) at 375 mg/m2 intravenously every 14 day; Levofloxacin at 500 mg orally daily; Diflucan at 200 mg orally daily~One cycle lasts 28 days. At least 2 but no more than 8 cycles will be administered to each patient"
531576|NCT00250718|E1|Reported Event|Arm 1 Combination Treatment|"VP-16 50mg/d PO x14 days q 28 days + Chlorambucil 0.1mg/kg/d PO x14 days q 28 days + Vincristine 2mg IV x14 days + Dexamethasone 200mg IV q 24 days + Rituxan (rituximab) 375 mg/m2 IVI x14 days + Levofloxacin 500 mg PO qd + Diflucan 200 mg PO qd~Vincristine: should be administered intravenously through a freely-running IV at 2mg q 14 days.~VP-16: The VP-16 is optional for the first cycle if the patient has delays in obtaining the drug. Dose and schedule 50 mg/d P.O. x14 days q 28 days.~Rituximab: The total amount of rituximab needed for a patient's entire infusions (one course) will be determined at study entry. A single dose of 375 mg/m2 will be based upon the patient's actual body surface area calculated during the baseline evaluation. The dose level of rituximab will not be adjusted.~Dexamethasone: Dexamethasone will be administered at 200mg q 14 days. Dexamethasone should be administered over a 1 hour infusion.~Levofloxacin: Levofloxacin will be administ"
531577|NCT00250679|B4|Baseline|Total|Total of all reporting groups
531578|NCT00250679|B3|Baseline|Arformoterol 25 Mcg 2x/Day|
531579|NCT00250679|B2|Baseline|Arformoterol 15 Mcg 2x/Day|
531580|NCT00250679|B1|Baseline|Formoterol 12 Mcg 2x/Day|
531581|NCT00250679|P3|Participant Flow|Arformoterol 25 Mcg 2x/Day|
531582|NCT00250679|P2|Participant Flow|Arformoterol 15 Mcg 2x/Day|
531583|NCT00250679|P1|Participant Flow|Formoterol 12 Mcg 2x/Day|
531584|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531585|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531586|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531587|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531588|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531589|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531590|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531591|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531646|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531647|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531648|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531649|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531650|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531651|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531652|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531653|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531654|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531655|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531656|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531657|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531658|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531659|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531660|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531661|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531662|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531663|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531664|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531665|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531666|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531667|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531668|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531669|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531670|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531671|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531672|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531673|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531674|NCT00250679|O3|Outcome|Arformoterol 25 Mcg 2x/Day|
531675|NCT00250679|O2|Outcome|Arformoterol 15 Mcg 2x/Day|
531676|NCT00250679|O1|Outcome|Formoterol 12 Mcg 2x/Day|
531677|NCT00250679|E3|Reported Event|Arformoterol 25 Mcg 2x/Day|
531678|NCT00250679|E2|Reported Event|Arformoterol 15 Mcg 2x/Day|
531679|NCT00250679|E1|Reported Event|Formoterol 12 Mcg 2x/Day|
531680|NCT00250588|B4|Baseline|Total|Total of all reporting groups
531681|NCT00250588|B3|Baseline|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531682|NCT00250588|B2|Baseline|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework – identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework – defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework – implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531683|NCT00250588|B1|Baseline|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor’s level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531684|NCT00250588|P3|Participant Flow|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531685|NCT00250588|P2|Participant Flow|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531686|NCT00250588|P1|Participant Flow|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531687|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531688|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531689|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531690|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531691|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531692|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531693|NCT00250588|O3|Outcome|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531694|NCT00250588|O2|Outcome|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531695|NCT00250588|O1|Outcome|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531696|NCT00250588|E3|Reported Event|Standard Care|The standard care wait list control group received ongoing asthma care from their place of care during the trial. They were offered the CC+PST intervention after the T3 follow up.
531737|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
531738|NCT00250458|E2|Reported Event|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
531739|NCT00250458|E1|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
531740|NCT00250432|B3|Baseline|Total|Total of all reporting groups
531741|NCT00250432|B2|Baseline|Caspofungin 150 mg|Caspofungin 150 mg IV daily
531742|NCT00250432|B1|Baseline|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
531697|NCT00250588|E2|Reported Event|Care Coordination+Problem Solving|The CC+PST consisted of CC plus a 6-session (45-60 minutes, weekly) problem-solving skills training intervention. Participants are taught to approach problems proactively, define the problem, generate alternative solutions, choose the best, implement the solution, and evaluate how well that solution worked. Session 1 was devoted to rapport building, understanding the relevant social and medical situation, presenting an overview of the PST curriculum, and assigning the first homework - identifying a solvable problem. Session 2 reviewed prior homework, introduced the idea of developing alternative solutions, and assigned homework - defining and evaluating options. Session 3 reviewed homework, developed an action plan and assigned homework - implementing the action plan. Sessions 4-6 depended on the outcome of the actions, focusing on alternative plans if the results of the action plan were not satisfactory to the client or on additional problems if the results were satisfactory.
531698|NCT00250588|E1|Reported Event|Care Coordination|The 5-session (45-60 minutes, weekly) CC was based on NHLBI guidelines and the RWJF's Allies Against Asthma community health worker model (Friedman et al., 2006) and was delivered by two bachelor's level bilingual, bicultural asthma home visitors. The home visitors implemented a structured set of educational interventions, with written materials in English or Spanish, on the following topics: what is asthma, asthma medications and devices, asthma action plan, how to recognize and respond to symptom onset, and how to reduce irritants and allergens in the home. Home visitors referred families, when necessary, to existing health insurance enrollment assistance, smoking cessation, and other community support services. Home visitors communicated with the primary care provider via FAX, giving summaries of interventions, updates on progress, and noting family difficulties and needs (for example, needing equipment, prescriptions, or an (updated) asthma treatment plan).
531699|NCT00250497|B3|Baseline|Total|Total of all reporting groups
531700|NCT00250497|B2|Baseline|Control Group|All Girls PE Control Group
531701|NCT00250497|B1|Baseline|Intervention Group|New Moves Intervention
531702|NCT00250497|P2|Participant Flow|Control Group|All Girls PE Control group
531703|NCT00250497|P1|Participant Flow|Intervention Group|New Moves Intervention
531704|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531705|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531706|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531707|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531708|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531709|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531710|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531711|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531712|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531713|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531714|NCT00250497|O2|Outcome|Control Group|All Girls PE Control Group
531715|NCT00250497|O1|Outcome|Intervention Group|New Moves Intervention Group
531716|NCT00250497|E2|Reported Event|Control Group|All Girls PE Control Group
531717|NCT00250497|E1|Reported Event|Intervention Group|New Moves Intervention Group
531718|NCT00250484|B3|Baseline|Total|Total of all reporting groups
531719|NCT00250484|B2|Baseline|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531720|NCT00250484|B1|Baseline|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531721|NCT00250484|P2|Participant Flow|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531722|NCT00250484|P1|Participant Flow|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531723|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531724|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531725|NCT00250484|O2|Outcome|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531726|NCT00250484|O1|Outcome|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531727|NCT00250484|E2|Reported Event|Sham Transcranial Magnetic Stimulation|"Patients will receive no active TMS/treatment.~Sham Transcranial Magnetic Stimulation: Sham procedure of transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531728|NCT00250484|E1|Reported Event|Transcranial Magnetic Stimulation|"Active treatment with TMS for 10 days.~Transcranial Magnetic Stimulation: 1Hz transcranial Magnetic Stimulation for 10 days for 26 minutes each day"
531729|NCT00250458|B3|Baseline|Total|Total of all reporting groups
531730|NCT00250458|B2|Baseline|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
531731|NCT00250458|B1|Baseline|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
531732|NCT00250458|P2|Participant Flow|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
531733|NCT00250458|P1|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
531734|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
531735|NCT00250458|O1|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg Orally Disintegrating Tablet (ODT), one dose, to treat a single migraine attack
531736|NCT00250458|O2|Outcome|Placebo|Placebo matching Rizatiptan 10 mg ODT, one dose, to treat a single migraine attack
531743|NCT00250432|P2|Participant Flow|Caspofungin 150 mg|Caspofungin 150 mg IV daily
531744|NCT00250432|P1|Participant Flow|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
531745|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
531746|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
531747|NCT00250432|O2|Outcome|Caspofungin 150 mg|Caspofungin 150 mg IV daily
531748|NCT00250432|O1|Outcome|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
531749|NCT00250432|E2|Reported Event|Caspofungin 150 mg|Caspofungin 150 mg IV daily
531750|NCT00250432|E1|Reported Event|Caspofungin 70/50 mg|Caspofungin 50 mg IV daily (following a 70-mg IV loading dose on Day 1)
531751|NCT00249873|B3|Baseline|Total|Total of all reporting groups
531752|NCT00249873|B2|Baseline|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531753|NCT00249873|B1|Baseline|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531754|NCT00249873|P2|Participant Flow|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531755|NCT00249873|P1|Participant Flow|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531756|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531757|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531758|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531759|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531760|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531761|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531762|NCT00249873|O2|Outcome|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531763|NCT00249873|O1|Outcome|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531764|NCT00249873|E2|Reported Event|Placebo + ASA|Matching placebo of clopidogrel 75 mg od plus ASA 75 to 100 mg od recommended (dose at the investigators' discretion)
531765|NCT00249873|E1|Reported Event|Clopidogrel + ASA|Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
531766|NCT00249821|B3|Baseline|Total|Total of all reporting groups
531767|NCT00249821|B2|Baseline|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531768|NCT00249821|B1|Baseline|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531769|NCT00249821|P2|Participant Flow|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531770|NCT00249821|P1|Participant Flow|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531771|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531772|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531773|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531774|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531775|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531776|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531777|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531778|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531779|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531780|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531781|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531782|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531783|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531784|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531785|NCT00249821|O2|Outcome|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531786|NCT00249821|O1|Outcome|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531787|NCT00249821|E2|Reported Event|Saizen® 0.035 mg/kg/Day|Saizen® (r-hGH) subcutaneously administered at the daily dose of 0.035 mg/kg or 0.24 mg/kg/week for duration of 12 months.
531788|NCT00249821|E1|Reported Event|Saizen® 0.057 mg/kg/Day|Saizen® (recombinant human growth hormone, r-hGH) subcutaneously administered at the daily dose of 0.057 milligram/kilogram (mg/kg) or 0.40 mg/kg/week for duration of 12 months.
531789|NCT00249795|B3|Baseline|Total|Total of all reporting groups
531790|NCT00249795|B2|Baseline|Placebo|matching placebo up to final follow-up visit
531791|NCT00249795|B1|Baseline|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531792|NCT00249795|P2|Participant Flow|Placebo|matching placebo up to final follow-up visit
531793|NCT00249795|P1|Participant Flow|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531794|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531795|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531796|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531797|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531798|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531799|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531800|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531801|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531802|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531803|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531804|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531805|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531806|NCT00249795|O2|Outcome|Placebo|matching placebo up to final follow-up visit
531807|NCT00249795|O1|Outcome|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531808|NCT00249795|E2|Reported Event|Placebo|matching placebo up to final follow-up visit
531809|NCT00249795|E1|Reported Event|Irbesartan|150 mg for 2 weeks, then uptitrated to 300 mg up to final follow-up visit
531810|NCT00249613|B3|Baseline|Total|Total of all reporting groups
531811|NCT00249613|B2|Baseline|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment for women and men
531812|NCT00249613|B1|Baseline|Women-Only Treatment 152 Subjects|Out-patient gender-responsive substance abuse treatment for women only
531813|NCT00249613|P2|Participant Flow|Mixed-Gender Treatment 139 Subjects|Out-patient substance abuse treatment that included both women and men
531814|NCT00249613|P1|Participant Flow|Women-Only Treatment 152 Subjects|Out patient gender-responsive substance abuse treatment for women only
531815|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender|Comparison of outcome in Women-Only vs. Mixed-Gender treatment
531816|NCT00249613|O1|Outcome|Group Status (Women-Only Compared to Mixed-Gender)|Outpatient gender-responsive substance abuse treatment for women only vs. outpatient mixed-gender substance abuse treatment
531817|NCT00249613|O1|Outcome|Women-Only Compared to Mixed-Gender|Outpatient gender-responsive substance abuse treatment for women only compared to outpatient substance abuse treatment for women and men
531818|NCT00249613|O2|Outcome|Mixed-Gender|Substance abuse treatment program for both women and men
531819|NCT00249613|O1|Outcome|Women-Only|"Substance abuse treatment program for women only~Women-Only: Gender-responsive treatment for women only"
531820|NCT00249613|E2|Reported Event|Mixed-Gender|Outpatient mixed-gender substance abuse treatment
531821|NCT00249613|E1|Reported Event|Women-Only|Outpatient gender-responsive substance abuse treatment for women only
531822|NCT00249496|B3|Baseline|Total|Total of all reporting groups
531823|NCT00249496|B2|Baseline|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
531824|NCT00249496|B1|Baseline|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
531825|NCT00249496|P2|Participant Flow|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
531826|NCT00249496|P1|Participant Flow|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
531844|NCT00249379|P1|Participant Flow|Acamprosate|Criminal justice supervisees given acamprosate 333 mg, 2 tablets orally 3 times daily for alcohol dependence for a 12-week period
531845|NCT00249379|O2|Outcome|Control|
531846|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
531827|NCT00249496|O2|Outcome|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
531828|NCT00249496|O1|Outcome|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
531829|NCT00249496|E2|Reported Event|Contingency Management|"Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary.~Contingency management: Participants in the Contingency Management group will be employed for one year in a Therapeutic Workplace business and will have to provide drug-free urine samples to work and earn salary."
531830|NCT00249496|E1|Reported Event|Employment Only|"Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work.~Employment Only: Employment Only participants will be offered employment for one year, but these participants will not have to provide drug-free urine samples to work."
531831|NCT00249470|B3|Baseline|Total|Total of all reporting groups
531832|NCT00249470|B2|Baseline|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
531833|NCT00249470|B1|Baseline|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
531834|NCT00249470|P2|Participant Flow|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
531835|NCT00249470|P1|Participant Flow|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
531836|NCT00249470|O2|Outcome|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
531837|NCT00249470|O1|Outcome|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
531838|NCT00249470|E2|Reported Event|Work Only|"Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results.~Work Only: Work Only participants were invited to attend the workplace throughout a 26-week intervention period. Participants in this group continued to provide mandatory urine samples and could earn base and performance pay. Work Only participants could work and earn base and performance pay independent of urinalysis results."
531839|NCT00249470|E1|Reported Event|Abstinence & Work|"Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour.~Abstinence & Work: Participants in the Abstinence & Work group were invited to attend the workplace throughout a 26-week intervention period, but were required to provide urine samples that indicated recent cocaine abstinence to gain access to the workplace and to maintain the maximum base pay of $8.00 per hour."
531840|NCT00249379|B3|Baseline|Total|Total of all reporting groups
531841|NCT00249379|B2|Baseline|Control|No specific intervention, monitored for outcomes
531842|NCT00249379|B1|Baseline|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
531843|NCT00249379|P2|Participant Flow|Control|No specific intervention, received standard Drug Court counseling, monitored for outcomes
531847|NCT00249379|O2|Outcome|Control|
531848|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
531849|NCT00249379|O2|Outcome|Control|
531850|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
531851|NCT00249379|O2|Outcome|Control|
531852|NCT00249379|O1|Outcome|Acamprosate|participants taking study medication
531853|NCT00249379|E2|Reported Event|Control|No specific intervention, monitored for outcomes
531854|NCT00249379|E1|Reported Event|Acamprosate|Criminal justice supervisees given acamprosate for alcohol dependence
531855|NCT00249288|B3|Baseline|Total|Total of all reporting groups
531856|NCT00249288|B2|Baseline|Folate|Patients underwent a 12 week trial of folate 2 mg/d
531857|NCT00249288|B1|Baseline|Placebo|Participants received 2 mg/daily of placebo, for 12 weeks
531858|NCT00249288|P2|Participant Flow|Placebo|
531859|NCT00249288|P1|Participant Flow|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
531860|NCT00249288|O2|Outcome|Placebo|"Participants will receive a 2 mg/ day dose of placebo, for 12 weeks~Placebo: Placebo taken by mouth daily as 2, 1mg capsule daily for 12 weeks"
531861|NCT00249288|O1|Outcome|Folate|"Participants will receive a 2 mg/ day dose of folate, for 12 weeks~Folate: Folic acid taken as 2, 1mg capsule daily for 12 weeks"
531862|NCT00249288|E2|Reported Event|Placebo|Participants receiving 2mg/daily of placebo, for 12 weeks
531863|NCT00249288|E1|Reported Event|Folate|Participants receiving 2 mg/daily of folate, for 12 weeks
531864|NCT00249249|B5|Baseline|Total|Total of all reporting groups
531865|NCT00249249|B4|Baseline|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531866|NCT00249249|B3|Baseline|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531867|NCT00249249|B2|Baseline|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531868|NCT00249249|B1|Baseline|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531869|NCT00249249|P4|Participant Flow|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531870|NCT00249249|P3|Participant Flow|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531871|NCT00249249|P2|Participant Flow|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531872|NCT00249249|P1|Participant Flow|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531873|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531874|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531875|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531876|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531877|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531878|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531879|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531880|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531881|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531882|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531883|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531884|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531885|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531886|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531887|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531888|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531889|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531890|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531891|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531892|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531893|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531894|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531895|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531896|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531897|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531898|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531899|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531900|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531901|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531902|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531903|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531904|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531905|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531906|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531907|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531908|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531909|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531910|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531911|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531912|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531913|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531914|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531915|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531916|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531917|NCT00249249|O4|Outcome|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531918|NCT00249249|O3|Outcome|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531919|NCT00249249|O2|Outcome|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531920|NCT00249249|O1|Outcome|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531921|NCT00249249|E4|Reported Event|Atorvastatin 20 mg QD|Atorvastatin 20 mg daily
531922|NCT00249249|E3|Reported Event|Pitavastatin 4 mg QD|Pitavastatin 4 mg daily
531923|NCT00249249|E2|Reported Event|Atorvastatin 10 mg QD|Atorvastatin 10 mg daily
531924|NCT00249249|E1|Reported Event|Pitavastatin 2 mg QD|Pitavastatin 2 mg daily
531925|NCT00247962|B3|Baseline|Total|Total of all reporting groups
531926|NCT00247962|B2|Baseline|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
531927|NCT00247962|B1|Baseline|Etanercept|etanercept 50 mg once weekly
531928|NCT00247962|P2|Participant Flow|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
531929|NCT00247962|P1|Participant Flow|Etanercept|etanercept 50 mg once weekly
531930|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
531931|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
531932|NCT00247962|O2|Outcome|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
531933|NCT00247962|O1|Outcome|Etanercept|etanercept 50 mg once weekly
531934|NCT00247962|E2|Reported Event|Sulphasalazine|Sulphasalazine (SSZ) titration up to 3 g daily
531935|NCT00247962|E1|Reported Event|Etanercept|etanercept 50 mg once weekly
531936|NCT00249002|B1|Baseline|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531937|NCT00249002|P1|Participant Flow|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531938|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531939|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531940|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531941|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531942|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531943|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531944|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531945|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531946|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531947|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531948|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531949|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531950|NCT00249002|O1|Outcome|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531951|NCT00249002|E1|Reported Event|ABI-007|ABI-007 35 mg/m^2 given intravenously (IV) into the arteriovenous (AV) graft within 96 hours after angioplasty, followed by repeat treatment during weeks 5, 13 and 21
531952|NCT00248807|B3|Baseline|Total|Total of all reporting groups
531953|NCT00248807|B2|Baseline|Non-spinal Cord Injured Subjects|Non-spinal cord injured subjects underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
531954|NCT00248807|B1|Baseline|Subjects With Spinal Cord Injury|Subjects with spinal cord injury underwent a 45 degree head-up tilt maneuver to lower blood pressure and monitor cerebral blood flow on 2 study visits. The first visit subject underwent the head-up tilt maneuver without drug and on the second visits subject underwent the head-up tilt maneuver following oral administration of an angiotensin converting enzyme inhibitor (ACE: 1.25 mg enalaprilat).
531955|NCT00248807|P2|Participant Flow|Subjects Without SCI (Non-SCI)|Subjects without SCI (non-SCI) underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
531956|NCT00248807|P1|Participant Flow|Subjects With Spinal Cord Injury (SCI)|Subjects with SCI underwent a 45 degree head-up tilt maneuver to lower blood pressure and measure cerebral blood flow with and without enalaprilat (1.25 mg).
531957|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
531958|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
531959|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug.
531960|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug.
531961|NCT00248807|O4|Outcome|ARM 4|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
531962|NCT00248807|O3|Outcome|ARM 3|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury following intravenous administration of an angiotensin converting enzyme inhibitor (1.25 mg enalaprilat).
531963|NCT00248807|O2|Outcome|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied control subjects without drug
531964|NCT00248807|O1|Outcome|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury without drug
531965|NCT00248807|E4|Reported Event|ARM 4|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
531966|NCT00248807|E3|Reported Event|ARM 3|1.25 mg enalaprilat IV and 45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
531967|NCT00248807|E2|Reported Event|ARM 2|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in able-bodied controls.
531968|NCT00248807|E1|Reported Event|ARM 1|45 degree head-up tilt to lower blood pressure and measure cerebral blood flow in subjects with spinal cord injury.
531969|NCT00248794|B4|Baseline|Total|Total of all reporting groups
531970|NCT00248794|B3|Baseline|Skills Group Only|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
531971|NCT00248794|B2|Baseline|ICBCR + Skills Group|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
531972|NCT00248794|B1|Baseline|CRT +Skills Group|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
531973|NCT00248794|P3|Participant Flow|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
531974|NCT00248794|P2|Participant Flow|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
531975|NCT00248794|P1|Participant Flow|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
531976|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
531977|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531978|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531979|NCT00248794|O3|Outcome|Skills Group Control|Participants receive upto 5 hours of generic staff contact and weekly skills training group for 15 weeks
531980|NCT00248794|O2|Outcome|ICBCR and Skills Training|Participants receive upto 5 hours of ICBCR and weekly skills training group for 15 weeks
531981|NCT00248794|O1|Outcome|CRT + Skills Training|Participants receive upto 5 hours of CRT and weekly skills training group for 15 weeks
531982|NCT00248794|O3|Outcome|Skills Group Control|Participants received weekly skills group + up to five individual contacts with research staff without active cognitive training
531983|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation~Participants received up to 5 hours of ICBRC and weekly skills group"
531984|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy+ skills training~Participants received up to 5 hours of CRT and weekly skills training group"
531985|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
531986|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531987|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531988|NCT00248794|O3|Outcome|Skills Group Control|Life skills group + up to five individual contacts with research staff without active cognitive training
531989|NCT00248794|O2|Outcome|ICBCR and Skills Training|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531990|NCT00248794|O1|Outcome|CRT + Skills Training|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531991|NCT00248794|E3|Reported Event|Skills Group + Generic Contact|Life skills group + up to five individual contacts with research staff without active cognitive training
531992|NCT00248794|E2|Reported Event|ICBCR + Skills Group|"Individualized Computer Based Cognitive Remediation-Up to 5 hours of of computer based cognitive remediation (ICBCR). All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
532038|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532171|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
531993|NCT00248794|E1|Reported Event|CRT+Skills Group|"Cognitive Remediation therapy-Up to 5 hours of one on one cognitive remediation using CRT. All subjects randomized to this condition also are receiving the weekly skills group.~Cognitive rehabilitation (CRT and ICBCR): CRT is a one on one cognitive skills training method while ICBCR is a computer-based methods to improve cognitive abilities"
531994|NCT00248781|B3|Baseline|Total|Total of all reporting groups
531995|NCT00248781|B2|Baseline|Arm 2|attention control (health education)
531996|NCT00248781|B1|Baseline|Arm 1|Telecommunications system for exercise
531997|NCT00248781|P2|Participant Flow|Attention Control Group|attention control (health education)
531998|NCT00248781|P1|Participant Flow|Automated Exercise Group|Telecommunications system for exercise
531999|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532000|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532001|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532002|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532003|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532004|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532005|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532006|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532007|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532008|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532009|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532010|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532011|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532012|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532013|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532014|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532015|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532016|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532017|NCT00248781|O2|Outcome|Attention Control Group|attention control (health education)
532018|NCT00248781|O1|Outcome|Automated Exercise Group|Telecommunications system for exercise
532019|NCT00248781|E2|Reported Event|Attention Control Group|attention control (health education)
532020|NCT00248781|E1|Reported Event|Automated Exercise Group|Telecommunications system for exercise
532021|NCT00248651|B4|Baseline|Total|Total of all reporting groups
532022|NCT00248651|B3|Baseline|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532023|NCT00248651|B2|Baseline|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532024|NCT00248651|B1|Baseline|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532025|NCT00248651|P3|Participant Flow|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532026|NCT00248651|P2|Participant Flow|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532027|NCT00248651|P1|Participant Flow|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532028|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532029|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532030|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532031|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532032|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532033|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532034|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532035|NCT00248651|O2|Outcome|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532036|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532037|NCT00248651|O3|Outcome|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532039|NCT00248651|O1|Outcome|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532040|NCT00248651|E3|Reported Event|Placebo|Placebo escitalopram tablets and placebo amitriptyline capsules will be taken by mouth half an hour before bedtime for 12 weeks.
532041|NCT00248651|E2|Reported Event|Escitalopram|Escitalopram tablet (10 mg) plus a placebo amitriptyline capsule will be taken by mouth at night half an hour before bedtime for 12 weeks.
532042|NCT00248651|E1|Reported Event|Amitriptyline|Amitriptyline capsule (50 mg) plus a placebo escitalopram tablet will be taken at night half an hour before bedtime. To maximize patient tolerability, in the first 2 weeks the dose of amitriptyline will be 25 mg and then the dose will be increased to 50 mg, but the 25 mg and 50 mg capsules will be indistinguishable to maintain blinding.
532043|NCT00248638|B3|Baseline|Total|Total of all reporting groups
532044|NCT00248638|B2|Baseline|Standard|Participants given standard nutrition without glutamine dipeptide
532045|NCT00248638|B1|Baseline|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
532046|NCT00248638|P2|Participant Flow|Standard|Participants given standard nutrition without glutamine dipeptide
532047|NCT00248638|P1|Participant Flow|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
532048|NCT00248638|O2|Outcome|Standard|"Participants given standard nutrition without glutamine dipeptide~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
532049|NCT00248638|O1|Outcome|Glutamine Dipeptide|"Glutamine dipeptide supplemented nutrition to be given to participants.~Glutamine dipeptide: Subjects randomized to AG-PN will receive PN containing 0.5 g/kg/day of L alanyl L GLN (AG) dipeptide (Dipeptiven 20%; Fresenius-Kabi) and 1.0 g/kg/day of 15% Clinisol (Baxter Inc., Deerfield, IL) AA solution (total = 1.5 g/kg/day, with AG replacing 1/3 of Clinisol AA). Subjects randomized to STD-PN will receive PN AA as the standard, GLN-free amino acid solution (15% Clinisol). The AA solutions are nearly isonitrogenous; STD-PN provides 2.35 g nitrogen and the AG-PN provides 2.45 g nitrogen per 100 ml 15% AA solution. The amount of GLN dipeptide administered each day will be determined by daily PN volume intake data.~Study subjects will receive a maximum of 28 days of study PN (blinded placebo or GLN-dipeptide-supplemented PN). If the subject continues to require PN after Day 28, study PN and GLN dipeptide will be discontinued."
532050|NCT00248638|O2|Outcome|Standard|Participants given standard nutrition without glutamine dipeptide
532051|NCT00248638|O1|Outcome|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
532052|NCT00248638|E2|Reported Event|Standard|Participants given standard nutrition without glutamine dipeptide
532053|NCT00248638|E1|Reported Event|Glutamine Dipeptide|Glutamine dipeptide supplemented nutrition to be given to participants.
532054|NCT00248625|B3|Baseline|Total|Total of all reporting groups
532055|NCT00248625|B2|Baseline|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532056|NCT00248625|B1|Baseline|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532057|NCT00248625|P2|Participant Flow|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization.~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
532058|NCT00248625|P1|Participant Flow|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to placebo consisting of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, liver transplantation, or death within 7 days of randomization.~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive N-acetylcysteine (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications."
532059|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532077|NCT00248560|B1|Baseline|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
532078|NCT00248560|P1|Participant Flow|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
532172|NCT00247611|O1|Outcome|Control (ITT Sample %)|287 (94%) of the 304 randomized to control
532060|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532061|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532062|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532063|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532064|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532065|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532066|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532067|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532068|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532069|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532070|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532071|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532072|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532073|NCT00248625|O2|Outcome|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: placebo consisting of an equal volume of D5W alone for up to 7 days following entry into the study"
532074|NCT00248625|O1|Outcome|N-acetylcysteine (NAC)|Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study.
532075|NCT00248625|E2|Reported Event|Placebo|"Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive~Dextrose in water: Eligible children were adaptively allocated within strata defined by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) and water or placebo consisting of an equal volume of D5W alone. Volumes were adjusted for small children. Study medications were infused over 24 hours for up to 7 consecutive days in a dedicated line without other medications. Treatment was stopped earlier than 7 days in the case of hospital discharge, LTx, or death within 7 days of randomization."
532076|NCT00248625|E1|Reported Event|N-acetylcysteine (NAC)|"Eligible children were adaptively allocated by age (less than 2 years of age or at least 2 years old) and HE (grade 0-1 or 2-4) to receive NAC (150 mg/kg/d) in 5% dextrose (D5W) infused over 24 hours for up to 7 consecutive days~N-acetylcysteine: The study drug is administered as a continuous infusion at a dose of 150 mg/kg/day for up to 7 days following entry into the study. The infusion is discontinued at the time of death, liver transplant or discharge."
533122|NCT00243386|O2|Outcome|<14 Years of Age|
532079|NCT00248560|O1|Outcome|Gemcitabine Hydrochloride, Docetaxel|Gemcitabine hydrochloride given 3000 mg/m2 IV over 30 minutes and Docetaxel given 60mg/m2 IV over 60 minutes. The Docetaxel should be administered after the Gemcitabine hydrochloride.
532080|NCT00248560|E1|Reported Event|Gemcitabine, Docetaxel|"docetaxel~gemcitabine hydrochloride"
532081|NCT00248547|B3|Baseline|Total|Total of all reporting groups
532082|NCT00248547|B2|Baseline|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532083|NCT00248547|B1|Baseline|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532084|NCT00248547|P2|Participant Flow|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532085|NCT00248547|P1|Participant Flow|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532086|NCT00248547|O2|Outcome|Placebo (Sugar Pill)|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532087|NCT00248547|O1|Outcome|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532088|NCT00248547|E2|Reported Event|Placebo|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532089|NCT00248547|E1|Reported Event|Aprepitant|Loading dose of 125 mg capsule once a day for one day, then maintenance dose of 80 mg capsule daily through Day +4 of Bone Marrow Transplant
532090|NCT00248287|B3|Baseline|Total|Total of all reporting groups
532091|NCT00248287|B2|Baseline|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532092|NCT00248287|B1|Baseline|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532093|NCT00248287|P2|Participant Flow|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532094|NCT00248287|P1|Participant Flow|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532095|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532096|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532097|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532098|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532099|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532100|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532101|NCT00248287|O2|Outcome|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532102|NCT00248287|O1|Outcome|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532103|NCT00248287|E2|Reported Event|Irinotecan+Carboplatin+Cetuximab|Patients treated with Irinotecan + Carboplatin + Cetuximab
532104|NCT00248287|E1|Reported Event|Irinotecan+Carboplatin|Patients treated with Irinotecan + Carboplatin
532105|NCT00248170|B3|Baseline|Total|Total of all reporting groups
532106|NCT00248170|B2|Baseline|Anastrozole|1 mg p.o. once daily
532107|NCT00248170|B1|Baseline|Letrozole|2.5 mg by mouth (p.o.) once daily
532108|NCT00248170|P2|Participant Flow|Anastrozole|1 mg p.o. once daily
532109|NCT00248170|P1|Participant Flow|Letrozole|2.5 mg by mouth (p.o.) once daily
532110|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532111|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532112|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532113|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532114|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532115|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532116|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532117|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532118|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532119|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532120|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532121|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532122|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532123|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532124|NCT00248170|O2|Outcome|Anastrozole|1 mg p.o. once daily
532125|NCT00248170|O1|Outcome|Letrozole|2.5 mg by mouth (p.o.) once daily
532126|NCT00248170|E2|Reported Event|Anastrozole|Anastrozole
532127|NCT00248170|E1|Reported Event|Letrozole|Letrozole
532128|NCT00247676|B1|Baseline|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532129|NCT00247676|P1|Participant Flow|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532130|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532131|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532132|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532133|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532134|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532135|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532136|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532137|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532138|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532139|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532140|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532141|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532142|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532143|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532144|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532145|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532146|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532147|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532148|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532149|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532150|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532151|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532152|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532153|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532154|NCT00247676|O1|Outcome|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532155|NCT00247676|E1|Reported Event|50 Milligram (mg) Sunitinib|Subjects received open-label sunitinib malate at a starting dose of 50 mg once daily for 4 consecutive weeks followed by a 2-week rest period to form a complete cycle of 6 weeks.
532156|NCT00247611|B3|Baseline|Total|Total of all reporting groups
532157|NCT00247611|B2|Baseline|Intervention|Participants will receive the LifeWindows Intervention sessions
532158|NCT00247611|B1|Baseline|Control|Participants will receive the control condition
532159|NCT00247611|P2|Participant Flow|Intervention|Participants will receive the LifeWindows Intervention sessions
532160|NCT00247611|P1|Participant Flow|Control|Participants will receive the control condition
532161|NCT00247611|O2|Outcome|Total Excluded From OP Sample|ITT sample excluded from the post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions (ITT - OP sample)
532162|NCT00247611|O1|Outcome|On Protocol (OP) Sample|Post-hoc analysis of the participants provided >=6 assessments with no ART receipt interruptions
532163|NCT00247611|O4|Outcome|Intervention (On Protocol Sample)|152 (55%) of the ITT included intervention arm participants
532164|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
532165|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
532166|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
532167|NCT00247611|O2|Outcome|Intervention (ITT Sample)|277 (96%) of the 290 randomized to Intervention condition
532168|NCT00247611|O1|Outcome|Control (ITT Sample)|287 (94%) of the 304 randomized to control
532169|NCT00247611|O4|Outcome|Intervention (On Protocol)|152 (55%) of the ITT included intervention arm participants
532170|NCT00247611|O3|Outcome|Control (On Protocol Sample)|176 (61%) of the ITT included control arm participants
533123|NCT00243386|O1|Outcome|≥14 Years of Age|
532173|NCT00247611|E2|Reported Event|Intervention|Participants will receive the LifeWindows Intervention sessions
532174|NCT00247611|E1|Reported Event|Control|Participants will receive the control condition
532175|NCT00247416|B3|Baseline|Total|Total of all reporting groups
532176|NCT00247416|B2|Baseline|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532177|NCT00247416|B1|Baseline|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532178|NCT00247416|P2|Participant Flow|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532179|NCT00247416|P1|Participant Flow|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532180|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532181|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532182|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532183|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532184|NCT00247416|O2|Outcome|Arm 2, Dexamethasone Pretreatment Test Arm|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532185|NCT00247416|O1|Outcome|Arm 1, Control, no Dexamethasone Pretreatment|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532186|NCT00247416|O2|Outcome|2 Dex|"Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Dexamethasone: 16 mg bid for 4 days prior to each chemotherapy start.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
532187|NCT00247416|O1|Outcome|1 No Dex|"No Dexamethasone~Gemcitabine: Gemcitabine 1000 mg/m^2 intravenously over 30 minutes on days 5 and 12.~Carboplatin: AUC 6.0 intravenously over 30 minutes on day 5."
532188|NCT00247416|E2|Reported Event|2 Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with dexamethasone pretreatment.Dexamethasone pretreatment = dexamethasone 16 mg, bid 4 days before and day of each chemotherapy treatment (days 1 and 8).
532189|NCT00247416|E1|Reported Event|1 No Dexamethasone|Patients with stage 4 untreated non-small cell lung cancer received carboplatin (AUC 6, day 1) and gemcitabine (1000 mg/m2 days 1, 8) for up to 6 cycles with no dexamethasone pretreatment.
532190|NCT00247377|B3|Baseline|Total|Total of all reporting groups
532191|NCT00247377|B2|Baseline|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532192|NCT00247377|B1|Baseline|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532193|NCT00247377|P2|Participant Flow|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532194|NCT00247377|P1|Participant Flow|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532195|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532196|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532197|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532198|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532199|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532200|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532201|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532202|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532203|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532204|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532205|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532206|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532207|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
533300|NCT00242619|O1|Outcome|Completers|Subjects who completed the study.
532208|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532209|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532210|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532211|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532212|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532213|NCT00247377|O2|Outcome|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532214|NCT00247377|O1|Outcome|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532215|NCT00247377|E2|Reported Event|Laparoscopic Adjustable Gastric Banding (LAP-BAND)|Laparoscopic Adjustable Gastric Banding (LAP-BAND)instead of laparoscopic gastric bypass
532216|NCT00247377|E1|Reported Event|Laparoscopic Gastric Bypass|Laparoscopic Gastric Bypass instead of LAP-Band
532217|NCT00247273|B3|Baseline|Total|Total of all reporting groups
532218|NCT00247273|B2|Baseline|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532219|NCT00247273|B1|Baseline|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532220|NCT00247273|P2|Participant Flow|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532221|NCT00247273|P1|Participant Flow|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532222|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532223|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532224|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532225|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532226|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532227|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532228|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532229|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532230|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532231|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532232|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532233|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532234|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532235|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532236|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532237|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532238|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532239|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532240|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532241|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532242|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532243|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532244|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532245|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532246|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532247|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532248|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532249|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532250|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532251|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532252|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532253|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532254|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532255|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532256|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532257|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532258|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532259|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532260|NCT00247273|O2|Outcome|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532261|NCT00247273|O1|Outcome|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532262|NCT00247273|E2|Reported Event|150 mg Risedronate|150 mg risedronate taken once a month for 2 years
532263|NCT00247273|E1|Reported Event|5 mg Risedronate|5 mg risedronate tablet, once daily for 2 years
532264|NCT00246805|B3|Baseline|Total|Total of all reporting groups
532265|NCT00246805|B2|Baseline|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532266|NCT00246805|B1|Baseline|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532267|NCT00246805|P2|Participant Flow|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532268|NCT00246805|P1|Participant Flow|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532269|NCT00246805|O2|Outcome|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532270|NCT00246805|O1|Outcome|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532271|NCT00246805|E2|Reported Event|VRS OFF|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532272|NCT00246805|E1|Reported Event|VRS ON|Ventricular Rate Stabilization is a programmed function of the implanted pacemaker. After the first phase (VRS ON or OFF) patients cross-over for the second phase (VRS OFF or ON)
532273|NCT00246571|B3|Baseline|Total|Total of all reporting groups
532274|NCT00246571|B2|Baseline|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532275|NCT00246571|B1|Baseline|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532276|NCT00246571|P2|Participant Flow|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532277|NCT00246571|P1|Participant Flow|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532278|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532279|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532280|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532281|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532282|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532283|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532284|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532285|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532286|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532287|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532288|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532289|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532290|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532291|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532292|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532293|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532294|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532295|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532296|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532297|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532298|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532299|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532313|NCT00246571|E1|Reported Event|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532314|NCT00246519|B3|Baseline|Total|Total of all reporting groups
532315|NCT00246519|B2|Baseline|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
532300|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532301|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532302|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532303|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532304|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532305|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532306|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532307|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532308|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532309|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532310|NCT00246571|O2|Outcome|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 mg/m^2 BID Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid IV infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If RECIST defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532311|NCT00246571|O1|Outcome|Sunitinib|SU011248 (Sutent [sunitinib malate, hereafter referred to as sunitinib]) oral capsules, 37.5 milligrams (mg) once daily (QD) in a continuous regimen, expressed in 3-week cycles. 1-week treatment rests and dose reductions allowed for dose-limiting toxicity (DLT). Dose escalated to sunitinib 50 mg QD if minimal toxicities.
532312|NCT00246571|E2|Reported Event|Standard of Care|One of the following regimens was administered (at investigator's discretion): oral capecitabine 1000-1250 milligrams per square meter (mg/m^2) twice daily (BID) Days 1-14, every 3 weeks; vinorelbine 25-30 mg/m^2 rapid intravenous (IV) infusion or 60-80 mg/m^2 oral weekly, expressed in 3-week cycles; docetaxel 75-100 mg/m^2 via IV infusion every 3 weeks; paclitaxel 175-200 mg/m^2 via IV infusion every 3 weeks; paclitaxel 80-90 mg/m^2 weekly, in a continuous regimen expressed in 3-week cycles or 3 weeks of treatment followed by 1 week of rest; gemcitabine 800-1250 mg/m^2 via IV infusion, Days 1 and 8 every 3 weeks. If Response Evaluation Criteria in Solid Tumors (RECIST) defined progression was met, participants could receive sunitinib, 37.5 mg oral capsules QD, in continuous 3-week cycles.
532316|NCT00246519|B1|Baseline|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
532317|NCT00246519|P2|Participant Flow|Hydrochlorothiazide (HCTZ) + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
532318|NCT00246519|P1|Participant Flow|Atenolol + Hydroclorothiazide (HCTZ) Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
532319|NCT00246519|O2|Outcome|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
532320|NCT00246519|O1|Outcome|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
532321|NCT00246519|E2|Reported Event|HCTZ + Atenolol|HCTZ 12.5 mg then HCTZ 25 mg if BP < 120/70, then add atenolol 50 mg if BP < 120/70, then atenolol 100 mg if BP < 120/70.
532322|NCT00246519|E1|Reported Event|Atenolol +HCTZ Arm|atenolol 50 mg, then 100 mg if BP < 120/70, then add HCTZ 12.5 mg if BP < 120/70, then HCTZ 25 mg if BP < 120/70
532323|NCT00246376|B6|Baseline|Total|Total of all reporting groups
532324|NCT00246376|B5|Baseline|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
532325|NCT00246376|B4|Baseline|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
532326|NCT00246376|B3|Baseline|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
532327|NCT00246376|B2|Baseline|Group 2: Diet / Exercise|Diet, exercise, and two placebos
532328|NCT00246376|B1|Baseline|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
532329|NCT00246376|P5|Participant Flow|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
532330|NCT00246376|P4|Participant Flow|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
532331|NCT00246376|P3|Participant Flow|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
532332|NCT00246376|P2|Participant Flow|Group 2: Diet / Exercise|Diet, exercise, and two placebos
532333|NCT00246376|P1|Participant Flow|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
532334|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
532335|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
532336|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
532337|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
532338|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
532339|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
532340|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
532341|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
532342|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
532343|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
532344|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
532345|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
532346|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
532347|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
532348|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
532349|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
532350|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
532351|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
532352|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
532353|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
532354|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
532355|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
532356|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
532357|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise|
532358|NCT00246376|O1|Outcome|Group 1 - Usual Care|
532359|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|
532360|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|
532361|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|
532362|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|
532363|NCT00246376|O1|Outcome|Group 1 - Usual Care|
532364|NCT00246376|O5|Outcome|Group 5 - Diet/Exercise + Fenofibrate + Niacin|These subjects participated in the diet/exercise program and took active fenofibrate + active niacin.
532365|NCT00246376|O4|Outcome|Group 4 - Diet/Exercise + Niacin|These subjects participated in the diet/exercise program and took active niacin + fenofibrate placebo.
532366|NCT00246376|O3|Outcome|Group 3 - Diet/Exercise + Fenofibrate|These subjects participated in the diet/exercise program and took active fenofibrate + niacin placebo.
532367|NCT00246376|O2|Outcome|Group 2 - Diet/Exercise Only|These subjects participated in the diet/exercise program and took placebos.
532368|NCT00246376|O1|Outcome|Group 1 - Usual Care|These subjects did not participate in the diet/exercise program and took placebos.
532369|NCT00246376|E5|Reported Event|Group 5: Diet / Exercise + Niacin + Fenofibrate|Diet, exercise, Fenofibrate and Niaspan
532370|NCT00246376|E4|Reported Event|Group 4: Diet / Exercise + Niacin|Diet, exercise, Fenofibrate placebo, and Niaspan
532371|NCT00246376|E3|Reported Event|Group 3: Diet / Exercise + Fenofibrate|Diet, exercise, Fenofibrate, and Niaspan placebo
532372|NCT00246376|E2|Reported Event|Group 2: Diet / Exercise|Diet, exercise, and two placebos
532373|NCT00246376|E1|Reported Event|Group 1: Usual Care|Subjects receive lifestyle advice and placebos for Niaspan and Tricor
532374|NCT00246337|B10|Baseline|Total|Total of all reporting groups
532375|NCT00246337|B9|Baseline|Rizatriptan 10 mg|"Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532376|NCT00246337|B8|Baseline|MK0974 600 mg|"MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532377|NCT00246337|B7|Baseline|MK0974 400 mg|"MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532378|NCT00246337|B6|Baseline|MK0974 300 mg|"MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532379|NCT00246337|B5|Baseline|MK0974 200 mg|"MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532380|NCT00246337|B4|Baseline|MK0974 100 mg|"MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532381|NCT00246337|B3|Baseline|MK0974 50 mg|"MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532382|NCT00246337|B2|Baseline|MK0974 25 mg|"MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532383|NCT00246337|B1|Baseline|Placebo|"Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.~The reported number of participants are all patients randomized who received study drug and completed the study."
532384|NCT00246337|P9|Participant Flow|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532385|NCT00246337|P8|Participant Flow|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532386|NCT00246337|P7|Participant Flow|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532387|NCT00246337|P6|Participant Flow|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532388|NCT00246337|P5|Participant Flow|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532389|NCT00246337|P4|Participant Flow|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532390|NCT00246337|P3|Participant Flow|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532391|NCT00246337|P2|Participant Flow|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532392|NCT00246337|P1|Participant Flow|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532393|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532394|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532395|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532396|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532397|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532398|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532399|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532400|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532488|NCT00246025|B2|Baseline|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
533724|NCT00239681|O2|Outcome|Placebo|Placebo once daily
532401|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532402|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532403|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532404|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532405|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532406|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532407|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532408|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532409|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532410|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532411|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532412|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532413|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532414|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532415|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532416|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532417|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532418|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532419|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532420|NCT00246337|O9|Outcome|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532421|NCT00246337|O8|Outcome|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532422|NCT00246337|O7|Outcome|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532423|NCT00246337|O6|Outcome|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532424|NCT00246337|O5|Outcome|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532425|NCT00246337|O4|Outcome|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532426|NCT00246337|O3|Outcome|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532427|NCT00246337|O2|Outcome|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532428|NCT00246337|O1|Outcome|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532429|NCT00246337|E9|Reported Event|Rizatriptan 10 mg|Rizatriptan 10 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532430|NCT00246337|E8|Reported Event|MK0974 600 mg|MK0974 600 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532431|NCT00246337|E7|Reported Event|MK0974 400 mg|MK0974 400 mg; one orally-administered dose plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532432|NCT00246337|E6|Reported Event|MK0974 300 mg|MK0974 300 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532433|NCT00246337|E5|Reported Event|MK0974 200 mg|MK0974 200 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532434|NCT00246337|E4|Reported Event|MK0974 100 mg|MK0974 100 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532435|NCT00246337|E3|Reported Event|MK0974 50 mg|MK0974 50 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532436|NCT00246337|E2|Reported Event|MK0974 25 mg|MK0974 25 mg; one orally-administered dose, plus an optional second dose (placebo) to treat a single moderate-to-severe migraine headache.
532437|NCT00246337|E1|Reported Event|Placebo|Placebo to match assigned treatment arm; one orally-administered dose, plus an optional second dose of active drug, per assigned treatment arm, to treat a single moderate-to-severe migraine headache.
532438|NCT00246324|B1|Baseline|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
532439|NCT00246324|P1|Participant Flow|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
532440|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
532441|NCT00246324|O1|Outcome|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
532442|NCT00246324|E1|Reported Event|Inteferon, Then Interferon With Doxycycline|Men and women with RRMS who had received interferon beta-1a intramuscularly for at least six months and were experiencing breakthrough disease activity with the most recent relapse within 60 days of study entry.
532443|NCT00246259|B3|Baseline|Total|Total of all reporting groups
532444|NCT00246259|B2|Baseline|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532445|NCT00246259|B1|Baseline|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532446|NCT00246259|P2|Participant Flow|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532447|NCT00246259|P1|Participant Flow|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532448|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532449|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532450|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532451|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532452|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532453|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532454|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532455|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532456|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532457|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532458|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532459|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532460|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
533725|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
532461|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532462|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532463|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532464|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532465|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532466|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532467|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532468|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532469|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532470|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532471|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532472|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532473|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532474|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532475|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532476|NCT00246259|O2|Outcome|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532477|NCT00246259|O1|Outcome|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532478|NCT00246259|E2|Reported Event|Oral Antipsychotic|Oral antipsychotic (new or current treatment) was administered in which daily dose range permitted was risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants switched to another oral therapy as per Investigator’s discretion.
532479|NCT00246259|E1|Reported Event|Risperidone Long-acting Injection (LAI)|Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection was administered every 2 weeks as per Investigator’s discretion. An oral atypical antipsychotic was administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase.
532480|NCT00246090|B1|Baseline|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
532481|NCT00246090|P1|Participant Flow|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
532482|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
532483|NCT00246090|O1|Outcome|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
532484|NCT00246090|E1|Reported Event|E7389 1.4 mg/m^2|E7389 1.4 mg/m^2 intravenous bolus given over 2-5 minutes on Days 1 and 8 every 21 days.
532485|NCT00246025|B5|Baseline|Total|Total of all reporting groups
532486|NCT00246025|B4|Baseline|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532487|NCT00246025|B3|Baseline|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532489|NCT00246025|B1|Baseline|Treatment Group With Placebo|Patients were treated with matching Placebo.
532490|NCT00246025|P4|Participant Flow|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532491|NCT00246025|P3|Participant Flow|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532492|NCT00246025|P2|Participant Flow|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532493|NCT00246025|P1|Participant Flow|Treatment Group With Placebo|Patients were treated with matching Placebo.
532494|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532495|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532496|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532497|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532498|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532499|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532500|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532501|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532502|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532503|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532504|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532505|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532506|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532507|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532508|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532509|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532510|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532511|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532512|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532513|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532514|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532515|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532516|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532517|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532518|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532519|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532520|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532521|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532522|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532523|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532524|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532525|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532526|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532527|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532528|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532529|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532530|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532531|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532532|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532533|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532534|NCT00246025|O4|Outcome|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532535|NCT00246025|O3|Outcome|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532536|NCT00246025|O2|Outcome|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532537|NCT00246025|O1|Outcome|Treatment Group With Placebo|Patients were treated with matching Placebo.
532538|NCT00246025|E4|Reported Event|Dabigatran Etexilate 220 mg|Patients were treated with 220mg dabigatran etexilate once daily.
532539|NCT00246025|E3|Reported Event|Dabigatran Etexilate 150 mg|Patients were treated with 150mg dabigatran etexilate once daily.
532540|NCT00246025|E2|Reported Event|Dabigatran Etexilate 110 mg|Patients were treated with 110mg dabigatran etexilate once daily.
532541|NCT00246025|E1|Reported Event|Treatment Group With Placebo|Patients were treated with matching Placebo.
532542|NCT00246012|B10|Baseline|Total|Total of all reporting groups
532543|NCT00246012|B9|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532544|NCT00246012|B8|Baseline|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532545|NCT00246012|B7|Baseline|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532546|NCT00246012|B6|Baseline|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532547|NCT00246012|B5|Baseline|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532548|NCT00246012|B4|Baseline|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532549|NCT00246012|B3|Baseline|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532550|NCT00246012|B2|Baseline|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532551|NCT00246012|B1|Baseline|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532552|NCT00246012|P9|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532553|NCT00246012|P8|Participant Flow|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532554|NCT00246012|P7|Participant Flow|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532555|NCT00246012|P6|Participant Flow|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532556|NCT00246012|P5|Participant Flow|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532645|NCT00246012|E7|Reported Event|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532557|NCT00246012|P4|Participant Flow|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532558|NCT00246012|P3|Participant Flow|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532559|NCT00246012|P2|Participant Flow|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532560|NCT00246012|P1|Participant Flow|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532561|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532562|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532563|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532564|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532565|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532566|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532567|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532568|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532569|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532570|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532692|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532693|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532571|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532572|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532573|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532574|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532575|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532576|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532577|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532578|NCT00246012|O2|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532579|NCT00246012|O1|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532580|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532581|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532582|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532583|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532694|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532584|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532585|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532586|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532587|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532588|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532589|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532590|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532591|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532592|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532593|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532594|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532595|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532596|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532597|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532598|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532599|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532600|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532601|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532602|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532603|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532604|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532605|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532606|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532607|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532608|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532609|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532610|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532611|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532612|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532613|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532614|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532615|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532616|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532617|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532618|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 2]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532619|NCT00246012|O1|Outcome|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
532620|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532621|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532622|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532623|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532624|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532625|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532626|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532627|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532628|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532629|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532630|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532646|NCT00246012|E6|Reported Event|Dacarbazine + Placebo [Phase 2]|Placebo was administered intravenously over a period of 2 hr (±15 minutes). Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to placebo infusion. In case participants were unable to tolerate dacarbazine even after 2 dose reductions, they were given the option to continue with 10 mg/kg intetumumab alone.
533726|NCT00239681|O2|Outcome|Placebo|Placebo once daily
532631|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532632|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532633|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532634|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532635|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532636|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532637|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532638|NCT00246012|O5|Outcome|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532639|NCT00246012|O4|Outcome|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532640|NCT00246012|O3|Outcome|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532641|NCT00246012|O2|Outcome|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532642|NCT00246012|O1|Outcome|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532643|NCT00246012|E9|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532644|NCT00246012|E8|Reported Event|Intetumumab 10 mg/kg [Phase 2]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations.
532690|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532691|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
533727|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
532647|NCT00246012|E5|Reported Event|Dacarbazine + Intetumumab 10 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with SD or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 mg/m^2 intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532648|NCT00246012|E4|Reported Event|Dacarbazine + Intetumumab 5 mg/kg [Phase 1 (Part 2)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks for 8 cycles until no evidence of disease progression or unacceptable toxicity. If participants responded to therapy with stable disease (SD) or better, they were considered eligible to receive up to 8 cycles of extended administrations. Commercially available dacarbazine was administered at the dose of 1000 milligram per meter-square (mg/m^2) intravenously over a period of 60 minutes (± 30 minutes) prior to intetumumab infusion.
532649|NCT00246012|E3|Reported Event|Intetumumab 10 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 10 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs.
532650|NCT00246012|E2|Reported Event|Intetumumab 5 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 5 mg/kg as intravenous infusion over a period of 2 hr (± 15 minutes) once every 3 weeks until the occurrence of DLTs. If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532651|NCT00246012|E1|Reported Event|Intetumumab 3 mg/kg [Phase 1 (Part 1)]|Intetumumab was administered at the dose of 3 milligram per kilogram (mg/kg) as intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) over a period of 2 hours (hr) (± 15 minutes) once every 3 weeks until the occurrence of dose limiting toxicities (DLTs). If after an evaluation of the preliminary single-dose pharmacokinetics, receptor saturation was not observed at the 3 mg/kg or 5 mg/kg dose level, that dose of intetumumab was discontinued in Part 1 and participants were treated at the highest, documented safe dose level at which receptor saturation was observed.
532652|NCT00245960|B3|Baseline|Total|Total of all reporting groups
532653|NCT00245960|B2|Baseline|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532654|NCT00245960|B1|Baseline|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532655|NCT00245960|P2|Participant Flow|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532656|NCT00245960|P1|Participant Flow|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532657|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532658|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532659|NCT00245960|O2|Outcome|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532660|NCT00245960|O1|Outcome|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532661|NCT00245960|E2|Reported Event|Etanercept and Placebo|Period 1 received etanercept 50mg and placebo weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532662|NCT00245960|E1|Reported Event|Etanercept|Period 1 received etanercept 50mg bi-weekly for 12 weeks. Period 2 received etanercept 50mg weekly for 12 weeks.
532663|NCT00245856|B1|Baseline|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
532664|NCT00245856|P2|Participant Flow|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
532665|NCT00245856|P1|Participant Flow|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
532666|NCT00245856|O1|Outcome|Dalteparin + Warfarin/Dalteparin Alone|Major bleeding rates
532667|NCT00245856|O1|Outcome|Dalteparin + Warfarin or Dalteparin Alone|Patients with arm DVT who received either 3 months of dalteparin + warfarin (INR 2-3) or Dalteparin alone
532668|NCT00245856|O1|Outcome|All DVT Treated Patients|Participants received dalteparin 200units/kg followed by warfarin or dalteparin only for 3 months
532669|NCT00245856|E2|Reported Event|Dalteparin Only|200 units/kg for one month At month one, dosage reduction based on weight
532670|NCT00245856|E1|Reported Event|Dalteparin + Warfarin|"200 units per kg with transition Warfarin titrated to INR 2-3~This arm was completed and new treatment regimen was substituted for the remainder of the study."
532671|NCT00245635|B3|Baseline|Total|Total of all reporting groups
532672|NCT00245635|B2|Baseline|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
532673|NCT00245635|B1|Baseline|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
532674|NCT00245635|P2|Participant Flow|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
532675|NCT00245635|P1|Participant Flow|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
533728|NCT00239681|O2|Outcome|Placebo|Placebo once daily
532676|NCT00245635|O2|Outcome|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
532677|NCT00245635|O1|Outcome|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
532678|NCT00245635|E2|Reported Event|Placebo|"Placebo tablets will be given 1/day for the duration of the study with a dosing schedule equivalent to that of the drug.~Placebo: Placebo tablets will be given 1x/day for the duration of the study at a fixed/flexible dosing schedule similar to that for the drug fluoxetine based off of subjects' weight and side effects score."
532679|NCT00245635|E1|Reported Event|Fluoxetine|"Fixed/flexible dosing regimen of fluoxetine based on weight of subject and reaction to dosage, varying between 10mg and 80mg tablets once a day.~Fluoxetine: Tablets varying between 10mg and 80mg on a fixed/flexible dosing schedule based on the subjects' weight and side effects score."
532680|NCT00245570|B1|Baseline|Overall Study Population|All randomized patients
532681|NCT00245570|P6|Participant Flow|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
532682|NCT00245570|P5|Participant Flow|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
532683|NCT00245570|P4|Participant Flow|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
532684|NCT00245570|P3|Participant Flow|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
532685|NCT00245570|P2|Participant Flow|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
532686|NCT00245570|P1|Participant Flow|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
532687|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532688|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532689|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532695|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532696|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532697|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532698|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532699|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532700|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532701|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532702|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532703|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532704|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532705|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532706|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532707|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532708|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532709|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532710|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532711|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532712|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532713|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532714|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532715|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532716|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532717|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532718|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532719|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532720|NCT00245570|O3|Outcome|Placebo|All Placebo patients from all Treatment Periods.
532721|NCT00245570|O2|Outcome|Salmeterol 50-μg|All Salmeterol 50-μg patients from all Treatment Periods.
532722|NCT00245570|O1|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from all Treatment Periods.
532723|NCT00245570|E6|Reported Event|Placebo/ Salmeterol/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
532724|NCT00245570|E5|Reported Event|Placebo/ Montelukast/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo~inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
532725|NCT00245570|E4|Reported Event|Salmeterol/ Placebo/ Montelukast|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder."
532726|NCT00245570|E3|Reported Event|Salmeterol / Montelukast/ Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
532751|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532959|NCT00244010|E1|Reported Event|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
532727|NCT00245570|E2|Reported Event|Montelukast/ Placebo/ Salmeterol|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder."
532728|NCT00245570|E1|Reported Event|Montelukast/ Salmeterol/Placebo|"During Period I (placebo run-in), all patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder. During Period II, patients received a single witnessed dose of montelukast 10-mg oral tablet and salmeterol matching-image placebo inhalation powder.~Washout 1 (Washout between Periods II and III) 3- to 7-day washout between Periods II and III.~During Period III, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol 50-μg inhalation powder.~Washout 2 (Washout between Periods III and IV) 3- to 7-day washout between Periods III and IV.~During Period IV, patients received a single witnessed dose of montelukast matching-image placebo oral tablet followed immediately by salmeterol matching-image placebo inhalation powder."
532729|NCT00245557|B3|Baseline|Total|Total of all reporting groups
532730|NCT00245557|B2|Baseline|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
532731|NCT00245557|B1|Baseline|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
532732|NCT00245557|P2|Participant Flow|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
532733|NCT00245557|P1|Participant Flow|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
532734|NCT00245557|O2|Outcome|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
532735|NCT00245557|O1|Outcome|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
532736|NCT00245557|E2|Reported Event|Depressed (Baseline)|Depressed subjects receive sertraline open label for 12 weeks beginning at a dosage of 25 mg a day up to a maximum dosage of 200 mg a day.
532737|NCT00245557|E1|Reported Event|Healthy Controls (Baseline)|Healthy Controls undergo MRI and neuropsychological testing
532738|NCT00245466|B4|Baseline|Total|Total of all reporting groups
532739|NCT00245466|B3|Baseline|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532740|NCT00245466|B2|Baseline|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532741|NCT00245466|B1|Baseline|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532742|NCT00245466|P3|Participant Flow|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532743|NCT00245466|P2|Participant Flow|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532744|NCT00245466|P1|Participant Flow|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532745|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532746|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532747|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532748|NCT00245466|O3|Outcome|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532749|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532750|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532960|NCT00243932|B4|Baseline|Total|Total of all reporting groups
532752|NCT00245466|O2|Outcome|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532753|NCT00245466|O1|Outcome|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532754|NCT00245466|E3|Reported Event|Degarelix 80 + 20|In the main study (FE200486 CS02) one loading dose of degarelix 80 mg was given on Days 0. Maintenance doses of 20 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532755|NCT00245466|E2|Reported Event|Degarelix 40/40 + 40|In the main study (FE200486 CS02) loading doses of degarelix 40 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532756|NCT00245466|E1|Reported Event|Degarelix 80/80 + 40|In the main study (FE200486 CS02) loading doses of degarelix 80 mg were given on Days 0 and 3. Maintenance doses of 40 mg were given on days 28, 56, 84, 112 and 140. In the extension study (FE200486 CS02A) the same maintenance dose of degarelix was given once every 4 weeks.
532757|NCT00245219|B4|Baseline|Total|Total of all reporting groups
532758|NCT00245219|B3|Baseline|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532759|NCT00245219|B2|Baseline|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532760|NCT00245219|B1|Baseline|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532761|NCT00245219|P3|Participant Flow|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532762|NCT00245219|P2|Participant Flow|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532763|NCT00245219|P1|Participant Flow|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532764|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532765|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532766|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532767|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532768|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532769|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532770|NCT00245219|O3|Outcome|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532771|NCT00245219|O2|Outcome|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532772|NCT00245219|O1|Outcome|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532773|NCT00245219|E3|Reported Event|Education|The education group meetings focused on providing patients with information about their disease as well as methods to manage their illness and its side effects. Facilitators emphasized the theme of perceived control during all sessions, discussing how participants are in control of their illness experience and can have more control of their lives. A different topic was addressed in each session. Weekly homework assignments asked patients to write down something new they had learned from the session regarding how to take control of their lives. Meeting topics were as follows: Overview of breast cancer, treatment types and side effects, nutrition and diet management, exercise, body image, communication issues, relationships, and sexuality.
532774|NCT00245219|E2|Reported Event|Peer Support|The peer support group meetings focused on fostering purpose in life by providing participants with opportunities to support and care for one another. Patients completed a weekly diary of critical experiences or current life problems as homework, and were then encouraged to share these experiences in the group meetings. The group facilitator encouraged participants to help one another with these issues, and share how they had dealt with similar problems.
532775|NCT00245219|E1|Reported Event|Health Tracking (Control)|Participants assigned to the health-tracking condition received usual care and did not attend any meetings.
532776|NCT00245128|B1|Baseline|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
532777|NCT00245128|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
532778|NCT00245128|O1|Outcome|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
532779|NCT00245128|E1|Reported Event|Imatinib Mesylate (Gleevec)|Once daily oral administration of Imatinib Mesylate at a dose of 600mg for 12 months.
532780|NCT00245102|B7|Baseline|Total|Total of all reporting groups
532781|NCT00245102|B6|Baseline|Other Histology|Sorafenib 400 mg PO BID
532782|NCT00245102|B5|Baseline|Fibrosarcoma|Sorafenib 400 mg PO BID
532783|NCT00245102|B4|Baseline|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
532784|NCT00245102|B3|Baseline|Leiomyosarcoma|Sorafenib 400 mg PO BID
532785|NCT00245102|B2|Baseline|MPNST|Sorafenib 400 mg PO BID
532786|NCT00245102|B1|Baseline|Angiosarcoma|Sorafenib 400 mg PO BID
532787|NCT00245102|P6|Participant Flow|Other Histology|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532788|NCT00245102|P5|Participant Flow|Fibrosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532789|NCT00245102|P4|Participant Flow|Undifferentiated Pleomorphic Sarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532790|NCT00245102|P3|Participant Flow|Leiomyosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532791|NCT00245102|P2|Participant Flow|MPNST|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532792|NCT00245102|P1|Participant Flow|Angiosarcoma|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
532793|NCT00245102|O6|Outcome|Other Histology|Sorafenib 400 mg PO BID
532794|NCT00245102|O5|Outcome|Fibrosarcoma|Sorafenib 400 mg PO BID
532795|NCT00245102|O4|Outcome|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
532796|NCT00245102|O3|Outcome|Leiomyosarcoma|Sorafenib 400 mg PO BID
532797|NCT00245102|O2|Outcome|MPNST|Sorafenib 400 mg PO BID
532798|NCT00245102|O1|Outcome|Angiosarcoma|Sorafenib 400 mg PO BID
532799|NCT00245102|E6|Reported Event|Other Histology|Sorafenib 400 mg PO BID
532800|NCT00245102|E5|Reported Event|Fibrosarcoma|Sorafenib 400 mg PO BID
532801|NCT00245102|E4|Reported Event|Undifferentiated Pleomorphic Sarcoma|Sorafenib 400 mg PO BID
532802|NCT00245102|E3|Reported Event|Leiomyosarcoma|Sorafenib 400 mg PO BID
532803|NCT00245102|E2|Reported Event|MPNST|Sorafenib 400 mg PO BID
532804|NCT00245102|E1|Reported Event|Angiosarcoma|Sorafenib 400 mg PO BID
532805|NCT00245063|B3|Baseline|Total|Total of all reporting groups
532806|NCT00245063|B2|Baseline|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532807|NCT00245063|B1|Baseline|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532808|NCT00245063|P2|Participant Flow|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532958|NCT00244010|E2|Reported Event|Donor|Donors were not assessed for adverse events.
532809|NCT00245063|P1|Participant Flow|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532810|NCT00245063|O2|Outcome|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532811|NCT00245063|O1|Outcome|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532812|NCT00245063|E2|Reported Event|Arm B|"Patients receive oral AZD2171 30 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532813|NCT00245063|E1|Reported Event|Arm A|"Patients receive oral AZD2171 45 mg once daily for 28 days. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given PO"
532814|NCT00245050|B3|Baseline|Total|Total of all reporting groups
532815|NCT00245050|B2|Baseline|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
532816|NCT00245050|B1|Baseline|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
532817|NCT00245050|P2|Participant Flow|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
532818|NCT00245050|P1|Participant Flow|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
532819|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
532820|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
532821|NCT00245050|O2|Outcome|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
532822|NCT00245050|O1|Outcome|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
532823|NCT00245050|E2|Reported Event|Placebo|Arm II: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral placebo 100 mg twice daily on days 1-28.
532824|NCT00245050|E1|Reported Event|Pyridoxine|Arm I: Patients receive doxorubicin HCl liposome IV 40mg/m2 over 1 hour on day 1 and oral pyridoxine 100 mg twice daily on days 1-28.
532825|NCT00245011|B1|Baseline|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell collection. Samarium Sm153 Lexidronam Pentasodium is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of Samarium-153 is given, followed in 14 days by stem cell infusion.~Filgrastim: Filgrastim will be administered every day til count recovery Ifosfamide: Ifosfamide will be administered as part of Stem Cell transplant prep.~Peripheral blood stem cell transplantation: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium Sm 153 lexidronam pentasodium: First dose of Sm-EDTMP administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered 7 days later."
532826|NCT00245011|P1|Participant Flow|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (Samarium)/Stem Cell Transplant/Radiation arm: receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by collection of stem cells. Samarium is administered after collection of peripheral blood stem cells (PBCT). Once counts recover, while receiving filgrastim daily, a second, higher dose of Samarium-153 is given, followed in 14 days by infusion of the stem cells.~Filgrastim: administered daily until count recovery Ifosfamide: administered as part of Stem Cell transplant preparation. PBCT: Before administration of Samarium, collection of autologous hematopoietic stem cells Radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of Sm-EDTMP.~Samarium: First dose is administered after autologous stem cell collection. Second, higher dose, of SM-EDTMP administered after count recover. 14 days after administration of higher dose, patient undergoes autologous stem cell infusion."
532827|NCT00245011|O1|Outcome|Samarium-153/Stem Cell Transplant/Radiation|"Samarium Sm153 Lexidronam Pentasodium (^153Sm-EDTMP)/Stem Cell Transplant/Radiation arm will receive Ifosphamide IV in preparation for peripheral blood stem cell transplant followed by stem cell harvest. ^153Sm-EDTMP is administered after collection of peripheral blood stem cells. Once counts recover, while receiving filgrastim daily, a 2nd, higher dose of ^153Sm-EDTMP is given, followed in 14 days by stem cell infusion.~filgrastim: Filgrastim is administered every day til count recovery.~ifosfamide: Ifosfamide is administered as part of Stem Cell transplant prep.~peripheral blood stem cell harvesting: completed before administration of ^153Sm-EDTMP, collection of autologous hematopoietic stem cells.~radiation: Radiation Dosimetry performed at 4, 24, 48, and 72 after each infusion of ^153Sm-EDTMP.~^153Sm-EDTMP: First dose is administered after autologous stem cell collection. Second, higher dose, is administered 1 week later."
532828|NCT00245011|E1|Reported Event|Samarium-153|"Cytoxan+Ifosfamide, Filgrastim pre samarium.'Sm-EDTMP (low dose). once counts recover, Sm-EDTMP (high dose) given. Peripheral blood stem cell transplantation is done 14 days later.~filgrastim: Filgrastim will be administered post post chemotherapy until target WBC count is achieved.~ifosfamide: Ifosfamide administered IV.~peripheral blood stem cell transplantation: Peripheral blood stem cell transplantation is done 14 days after 2nd dose of Samarium is delivered~Sm-EDTMP (low dose): Sm-EDTMP (low dose) administered after autologous stem cell collection~sm-EDTMP (higher dose): Upon blood cell count recovery from Sm-EDTMP (low dose), Sm-EDTMP (higher dose) is administered followed in 14 days by peripheral blood stem cell transplantation."
532829|NCT00244933|B1|Baseline|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
533110|NCT00243386|O2|Outcome|<14 Years of Age|
532830|NCT00244933|P1|Participant Flow|Gemcitabine, Genistein (Novasoy), Tumor Biopsy|"Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~genistein: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.~gemcitabine: Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days~Tumor biopsy: Biopsy of tumor prior to dose of genistein (Novasoy)"
532831|NCT00244933|O1|Outcome|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
532832|NCT00244933|E1|Reported Event|Gemcitabine & Genistein|Gemcitabine, genistein (Novasoy), Tumor biopsy Gemcitabine IV-1000mg/m2: Days 1 & 8 every 21 days: Novasoy Orally-100 mg 2 times/day for 7 days; 2 times/day on Days 1-21 every 21 days.
532833|NCT00244881|B1|Baseline|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532834|NCT00244881|P1|Participant Flow|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532835|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532836|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532837|NCT00244881|O1|Outcome|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532838|NCT00244881|E1|Reported Event|Treatment (Cediranib Maleate)|Patients receive oral AZD2171 once daily for 42 days. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
532839|NCT00244764|B1|Baseline|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532840|NCT00244764|P1|Participant Flow|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532841|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 mg (tablets) administered orally once a day
532842|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532843|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532844|NCT00244764|O1|Outcome|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532845|NCT00244764|E1|Reported Event|Pazopanib 800 mg|Pazopanib 800 milligrams (mg) (tablets) administered orally once a day
532846|NCT00244712|B3|Baseline|Total|Total of all reporting groups
532847|NCT00244712|B2|Baseline|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532848|NCT00244712|B1|Baseline|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532849|NCT00244712|P2|Participant Flow|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532850|NCT00244712|P1|Participant Flow|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532851|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532852|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532853|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532854|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532855|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532856|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532857|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532858|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532859|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532860|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532861|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532862|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532863|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532864|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532865|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532866|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532867|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532868|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532869|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532870|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532871|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532872|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532873|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532874|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532875|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532876|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532877|NCT00244712|O2|Outcome|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532878|NCT00244712|O1|Outcome|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532879|NCT00244712|E2|Reported Event|Tenofovir/Emtricitabine (TDF/FTC) + LPV/RTV|1 tablet (300mg/200mg) TDF/FTC + 800mg/200mg LPV/RTV combination therapy once daily
532880|NCT00244712|E1|Reported Event|Abacavir/Lamivudine (ABC/3TC) + Lopinavir/Ritonavir (LPV/RTV)|1 tablet (600mg/300mg) ABC/3TC + 800mg/200mg LPV/RTV combination therapy once daily
532881|NCT00244621|B4|Baseline|Total|Total of all reporting groups
532882|NCT00244621|B3|Baseline|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532883|NCT00244621|B2|Baseline|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532884|NCT00244621|B1|Baseline|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532885|NCT00244621|P3|Participant Flow|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532886|NCT00244621|P2|Participant Flow|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532887|NCT00244621|P1|Participant Flow|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532888|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532889|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532890|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532891|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532892|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532893|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532894|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532895|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532896|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532897|NCT00244621|O3|Outcome|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532898|NCT00244621|O2|Outcome|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532899|NCT00244621|O1|Outcome|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532900|NCT00244621|E3|Reported Event|Atacand .40 mg|candesartan cilexetil (Atacand) 0.40 mg/kg once daily oral liquid dose
532901|NCT00244621|E2|Reported Event|Atacand .20 mg|candesartan cilexetil (Atacand) 0.20 mg/kg once daily oral liquid dose
532902|NCT00244621|E1|Reported Event|Atacand .05 mg|candesartan cilexetil (Atacand) 0.05 mg/kg once daily oral liquid dose
532903|NCT00244374|B1|Baseline|All Participants|Participants in pre-randomization cross-sectional study
532904|NCT00244374|P5|Participant Flow|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532905|NCT00244374|P4|Participant Flow|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
532906|NCT00244374|P3|Participant Flow|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532907|NCT00244374|P2|Participant Flow|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
532908|NCT00244374|P1|Participant Flow|Cross-sectional/Screening|Cross-sectional screening to determine eligibility for vaccine adherence trial
532909|NCT00244374|O1|Outcome|Screening Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
532910|NCT00244374|O1|Outcome|Cross-sectional Study Participants|Participants enrolled in the pre-randomization cross-sectional screening study completed a 60-minute survey, received client-centered risk reduction counseling, and underwent phlebotomy for viral testing. Participants were invited to return one week later for viral testing results, counseling, referrals, and subsequent enrollment in the vaccine adherence cohort study, if eligible.
532911|NCT00244374|O2|Outcome|Did Not Travel in the Prior 3 Months|"Participants who answered no when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, or whose last 3 travel destinations within 30 miles of San Francisco"
533111|NCT00243386|O1|Outcome|≥14 Years of Age|
532912|NCT00244374|O1|Outcome|Traveled in the Prior 3 Months|"Participants who answered yes when asked if they had been on the road or traveling outside of San Francisco in the prior 3 months, and whose last 3 travel destinations were at least 30 miles from San Francisco"
532913|NCT00244374|O2|Outcome|Anti-HCV Negative|Participants tested negative for Hepatitis C Virus (HCV) antibody
532914|NCT00244374|O1|Outcome|Anti-HCV Positive|Participants tested positive for Hepatitis C Virus (HCV) antibody
532915|NCT00244374|O4|Outcome|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532916|NCT00244374|O3|Outcome|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
532917|NCT00244374|O2|Outcome|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532918|NCT00244374|O1|Outcome|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
532919|NCT00244374|E4|Reported Event|SEP + Outreach|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532920|NCT00244374|E3|Reported Event|SEP Only|Subjects randomized to a set of syringe exchange programs for administration of viral hepatitis immunizations at Month 1, 2, 6.
532921|NCT00244374|E2|Reported Event|AIC + Outreach|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC)) for administration of viral hepatitis immunizations at Month 1, 2, 6, plus outreach worker adherence support to receive all immunizations
532922|NCT00244374|E1|Reported Event|AIC Only|Subjects randomized to a public health department clinic, the Adult Immunization Clinic (AIC), for administration of viral hepatitis immunizations at Month 1, 2, 6.
532923|NCT00244140|B3|Baseline|Total|Total of all reporting groups
532924|NCT00244140|B2|Baseline|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532925|NCT00244140|B1|Baseline|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532926|NCT00244140|P2|Participant Flow|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532927|NCT00244140|P1|Participant Flow|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532928|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532929|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532930|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532931|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532932|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532933|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532934|NCT00244140|O2|Outcome|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532935|NCT00244140|O1|Outcome|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532936|NCT00244140|E2|Reported Event|Iopromide 300 mg I/mL|Iopromide (Ultravist 300 mg I/mL) administered intravenously
532937|NCT00244140|E1|Reported Event|Iopromide 370 mg I/mL|Iopromide (Ultravist 370 mg I/mL) administered intravenously
532938|NCT00244101|B4|Baseline|Total|Total of all reporting groups
532939|NCT00244101|B3|Baseline|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
532940|NCT00244101|B2|Baseline|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
532941|NCT00244101|B1|Baseline|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
532942|NCT00244101|P3|Participant Flow|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
532943|NCT00244101|P2|Participant Flow|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
532944|NCT00244101|P1|Participant Flow|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
532945|NCT00244101|O3|Outcome|ISX Group|Intubation, prophylactic surfactant administration shortly after delivery, and rapid extubation to nasal CPAP.
532946|NCT00244101|O2|Outcome|NCPAP Group|Early stabilization on nasal continuous positive airway pressure (NCPAP) with selected intubation and surfactant administration for clinical indications.
532947|NCT00244101|O1|Outcome|PS Group|Intubation, prophylactic surfactant administration shortly after delivery, and subsequent stabilization on ventilator support.
532948|NCT00244101|E3|Reported Event|NCPAP|initial management with bubble nCPAP and selective surfactant treatment
532949|NCT00244101|E2|Reported Event|Surfactant Extubated to nCPAP|prophylactic surfactant with rapid extubation to bubble nCPAP
532950|NCT00244101|E1|Reported Event|Prophylactic Surfactant|Prophylactic surfactant followed by mechanical ventilation
532951|NCT00244010|B3|Baseline|Total|Total of all reporting groups
532952|NCT00244010|B2|Baseline|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
532953|NCT00244010|B1|Baseline|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
532954|NCT00244010|P2|Participant Flow|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
532955|NCT00244010|P1|Participant Flow|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
532956|NCT00244010|O2|Outcome|Donors|Parents of patients were enrolled onto the SAAHAP study to provide hematopoietic stem cells.
532957|NCT00244010|O1|Outcome|Patients|Patients were enrolled to treat refractory severe aplastic anemia.
532961|NCT00243932|B3|Baseline|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
532962|NCT00243932|B2|Baseline|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
532963|NCT00243932|B1|Baseline|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
532964|NCT00243932|P3|Participant Flow|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
532965|NCT00243932|P2|Participant Flow|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
532966|NCT00243932|P1|Participant Flow|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
532967|NCT00243932|O3|Outcome|1,800 mg CoQ10|35 patients. Mean and SD are presented but this group was not included in the efficacy analysis because the 1,800 mg dose was discontinued after stage 1.
532968|NCT00243932|O2|Outcome|Placebo|40 new subjects plus 35 subjects from stage 1 receiving placebo - total 75.
532969|NCT00243932|O1|Outcome|2700mg CoQ10|"40 new subjects and 35 subjects from stage 1 all taking 2,700mg CoQ10 - total 75.~Stage 1 - 35 participants per group compared CoQ10 doses of 1,800mg and 2,700 mg/day and placebo."
532970|NCT00243932|E3|Reported Event|1,800 mg CoQ10|35 patients. This dose group was discontinued after stage 1; only the 2,700 mg group was compared with placebo in the efficacy analysis.
532971|NCT00243932|E2|Reported Event|Placebo|35 subjects from stage 1 + 40 new subjects; all receiving placebo - total 75.
532972|NCT00243932|E1|Reported Event|2700mg CoQ10|35 subjects from stage 1 + 40 new subjects; all taking 2,700mg CoQ10 - total 75.
532973|NCT00243919|B4|Baseline|Total|Total of all reporting groups
532974|NCT00243919|B3|Baseline|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532975|NCT00243919|B2|Baseline|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532976|NCT00243919|B1|Baseline|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532977|NCT00243919|P3|Participant Flow|Home Exercise Program|Home Exercise Program (HEP) was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532978|NCT00243919|P2|Participant Flow|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532979|NCT00243919|P1|Participant Flow|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532980|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532981|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532982|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532983|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532984|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532985|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532986|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532987|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532988|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532989|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532990|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532991|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532992|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532993|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532994|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532995|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532996|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
532997|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
532998|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
532999|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533000|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533001|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533002|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533003|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533004|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533005|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533006|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533007|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533008|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533009|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533010|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533011|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533012|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533013|NCT00243919|O3|Outcome|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533014|NCT00243919|O2|Outcome|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533015|NCT00243919|O1|Outcome|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533016|NCT00243919|E3|Reported Event|Home Exercise Program|HEP was designed as an active control. The exercise program was progressed by a study physical therapist in the home to enhance flexibility, joint range of motion, upper- and lower-extremity strength, coordination and static and dynamic balance. Subjects were encouraged to walk daily. The home exercise program was delivered at 2 months post-stroke.
533017|NCT00243919|E2|Reported Event|Late Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 6 months post-stroke.
533018|NCT00243919|E1|Reported Event|Early Locomotor Training Program|Stepping on a treadmill with partial body weight support and manual assistance as needed for 20-30 minutes at 2.0 mph, followed by a progressive overground walking program for 20 minutes delivered at 2 months post-stroke.
533019|NCT00243659|B3|Baseline|Total|Total of all reporting groups
533020|NCT00243659|B2|Baseline|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
533021|NCT00243659|B1|Baseline|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
533022|NCT00243659|P2|Participant Flow|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
533023|NCT00243659|P1|Participant Flow|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
533024|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
533025|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
533026|NCT00243659|O2|Outcome|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
533027|NCT00243659|O1|Outcome|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
533028|NCT00243659|E2|Reported Event|Continuous Infusion|Approximately 50 IU/Kg Refacto AF then continuously
533029|NCT00243659|E1|Reported Event|Bolus Injection|Approximately 50 IU/kg Refacto AF for 6 consecutive days
533030|NCT00243503|B1|Baseline|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533031|NCT00243503|P1|Participant Flow|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533032|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533033|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533034|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533035|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533036|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533037|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533038|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533039|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533040|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533112|NCT00243386|O2|Outcome|<14 Years of Age|
533113|NCT00243386|O1|Outcome|≥14 Years of Age|
533114|NCT00243386|O2|Outcome|<14 Years of Age|
533115|NCT00243386|O1|Outcome|≥14 Years of Age|
533041|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533042|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles
533043|NCT00243503|O1|Outcome|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533044|NCT00243503|E1|Reported Event|Trastuzumab + Sunitinib|Trastuzumab was administered intravenously (i.v) weekly (loading 4 mg/kg followed by weekly 2 mg/kg) or every 3 weeks (loading 8 mg/kg followed by 6 mg/kg thrice weekly). Sunitinib began with 37.5 mg by oral capsule once daily in a continuous regimen. Treatment was administered in 4-week cycles.
533045|NCT00243412|B3|Baseline|Total|Total of all reporting groups
533046|NCT00243412|B2|Baseline|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533047|NCT00243412|B1|Baseline|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533048|NCT00243412|P2|Participant Flow|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion, For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533049|NCT00243412|P1|Participant Flow|Arm A: 500 mg Rituximab|Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533050|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533051|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533052|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533053|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533054|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533055|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533056|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533057|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533116|NCT00243386|O2|Outcome|<14 Years of Age|
533117|NCT00243386|O1|Outcome|≥14 Years of Age|
533118|NCT00243386|O2|Outcome|<14 Years of Age|
533058|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533059|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533060|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533061|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533062|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533063|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533064|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533065|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533066|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533067|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533068|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533069|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533070|NCT00243412|O2|Outcome|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533071|NCT00243412|O1|Outcome|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533072|NCT00243412|E2|Reported Event|Arm B: 1000 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12). For the Month 6 and 18 cycles, rituximab or placebo was administered. Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533119|NCT00243386|O1|Outcome|≥14 Years of Age|
533120|NCT00243386|O2|Outcome|<14 Years of Age|
533121|NCT00243386|O1|Outcome|≥14 Years of Age|
533073|NCT00243412|E1|Reported Event|Arm A: 500 mg Rituximab|Rituximab: 1000 mg IV on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18). Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion. Methotrexate: 15–25 mg/wk oral or parenteral (10–14 mg/wk if intolerant). Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
533074|NCT00243386|B1|Baseline|All Study Participants|Participants first underwent an open-label evaluation of rAHF-PFM PK. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
533075|NCT00243386|P3|Participant Flow|Standard Prophylaxis|The standard prophylactic regimen was dosed at 20 to 40 IU/kg of rAHF-PFM every 48 ±6 hours
533076|NCT00243386|P2|Participant Flow|PK-Driven Prophylaxis|The PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg of rAHF-PFM every 72 ±6 hours
533077|NCT00243386|P1|Participant Flow|All Study Participants|Participants first underwent an open-label pharmacokinetic (PK) evaluation of rAHF-PFM. 48 hours after the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1). After completing the on-demand treatment, participants were randomized to 1 of 2 prophylactic regimens for 12 months ±2 weeks (Part 2). The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
533078|NCT00243386|O4|Outcome|Any Prophylaxis|Either Standard or PK-driven Prophylaxis
533079|NCT00243386|O3|Outcome|PK-driven Prophylaxis|Dosed at 20 to 80 IU/kg every 72 ±6 hours for 12 months (Part 2)
533080|NCT00243386|O2|Outcome|Standard Prophylaxis|Dosed at 20 to 40 IU/kg every 48 ±6 hours for 12 months (Part 2)
533081|NCT00243386|O1|Outcome|On-Demand Regimen|After the initial PK study, a 6 month period of on-demand treatment was conducted (Part 1)
533082|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
533083|NCT00243386|O1|Outcome|≥14 Years of Age|After an on-demand treatment period, participants were randomized to 1 of 2 prophylactic regimens for 12 months. The standard prophylactic regimen was dosed at 20 to 40 IU/kg every 48 ±6 hours, and the PK-driven prophylaxis regimen was dosed at 20 to 80 IU/kg every 72 ±6 hours.
533084|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
533085|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
533086|NCT00243386|O3|Outcome|On-Demand to Any Prophylaxis Treatment|
533087|NCT00243386|O2|Outcome|On-Demand to PK-Driven Prophylaxis|
533088|NCT00243386|O1|Outcome|On-Demand to Standard Prophylaxis|
533089|NCT00243386|O4|Outcome|Any Prophylaxis Treatment|Any Prophylaxis Treatment (either Standard Prophylaxis or PK-Driven Prophylaxis) Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator PK-Driven Prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533090|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533091|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533092|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
533093|NCT00243386|O1|Outcome|Assessed Before Treatment|
533094|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533095|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533096|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours
533097|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to investigational product (IP)
533098|NCT00243386|O4|Outcome|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
533099|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533100|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533101|NCT00243386|O1|Outcome|On-Demand|
533102|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533103|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533104|NCT00243386|O1|Outcome|On-Demand|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
533105|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
533106|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to IP
533107|NCT00243386|O1|Outcome|All Study Participants|All participants who were exposed to Investigational Product (IP)
533108|NCT00243386|O2|Outcome|<14 Years of Age|
533109|NCT00243386|O1|Outcome|≥14 Years of Age|
533124|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533125|NCT00243386|O2|Outcome|Standard Prophylaxis|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533126|NCT00243386|O1|Outcome|On-Demand Regimen|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
533127|NCT00243386|O3|Outcome|PK-Driven Prophylaxis|20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor
533128|NCT00243386|O2|Outcome|Standard Prophylaxis Treatment|20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator
533129|NCT00243386|O1|Outcome|On-Demand Treatment|rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
533130|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
533131|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
533132|NCT00243386|O1|Outcome|On-Demand Versus Any Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~Prophylaxis:~Standard prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
533133|NCT00243386|O1|Outcome|On-Demand Versus PK-Driven Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)~PK-driven prophylaxis: 20-80 IU/kg (every 72 ± 6 hours), exact regimen to be determined by the sponsor"
533134|NCT00243386|O1|Outcome|On-Demand Versus Standard Prophylaxis|"On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, Gastrointestinal (GI), and intracranial (60-100 IU/kg every 8-12 hours)~Standard Prophylaxis: 20-40 IU/kg (every 48 ± 6 hours), exact regimen to be determined by the investigator"
533135|NCT00243386|O2|Outcome|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg every 48 ±6 hours
533136|NCT00243386|O1|Outcome|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg every 72 ±6 hours
533137|NCT00243386|E4|Reported Event|SAEs Outside of the 3 Treatment Arms|Participants with SAEs that occurred after exposure to investigational product, but outside of the three treatment arms
533138|NCT00243386|E3|Reported Event|PK-Driven Prophylaxis|PK-driven prophylaxis regimen dosed at 20 to 80 IU/kg (every 72 ±6 hours) exact regimen to be determined by the sponsor
533139|NCT00243386|E2|Reported Event|Standard Prophylaxis|Standard prophylaxis regimen dosed at 20 to 40 IU/kg (every 48 ±6 hours), exact regimen to be determined by the investigator
533140|NCT00243386|E1|Reported Event|On-Demand|On-demand: rAHF-PFM was to be used for the treatment of bleeding episodes according to the severity and type of episode by the protocol-recommended dosing until the episode resolved: superficial (10-20 IU/kg every 12-14 hours), minor joint (20-40 IU/kg every 12-14 hours), deep muscle (30-60 IU/kg every 12-14 hours), major joint or life-threatening (60-100 IU/kg every 8-12 hours), genitourinary, GI, and intracranial (60-100 IU/kg every 8-12 hours)
533141|NCT00243347|B1|Baseline|Cediranib 30 mg|Cediranib 30mg/Day
533142|NCT00243347|P1|Participant Flow|Cediranib 30 mg|Cediranib 30mg/Day
533143|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
533144|NCT00243347|O1|Outcome|Cediranib 30 mg|Cediranib 30mg/Day
533145|NCT00243347|E1|Reported Event|Cediranib 30 mg|Cediranib 30mg/Day
533146|NCT00243269|B5|Baseline|Total|Total of all reporting groups
533147|NCT00243269|B4|Baseline|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
533148|NCT00243269|B3|Baseline|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
533175|NCT00243243|E1|Reported Event|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
533176|NCT00243191|B1|Baseline|Imatinib|
533177|NCT00243191|P1|Participant Flow|Imatinib|
533178|NCT00243191|O1|Outcome|Imatinib|
533179|NCT00243191|E1|Reported Event|Imatinib|
533180|NCT00243074|B1|Baseline|AZD2171|
533181|NCT00243074|P1|Participant Flow|AZD2171 (Cediranib Maleate)|
533182|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
533183|NCT00243074|O1|Outcome|AZD2171|
533184|NCT00243074|O1|Outcome|AZD2171|
533149|NCT00243269|B2|Baseline|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
533150|NCT00243269|B1|Baseline|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
533151|NCT00243269|P4|Participant Flow|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
533152|NCT00243269|P3|Participant Flow|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
533153|NCT00243269|P2|Participant Flow|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
533154|NCT00243269|P1|Participant Flow|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
533155|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
533156|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
533157|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
533185|NCT00243074|O1|Outcome|AZD2171|
533186|NCT00243074|O1|Outcome|AZD2171|
533187|NCT00243074|O1|Outcome|AZD2171 (Cediranib Maleate)|
533188|NCT00243074|E1|Reported Event|AZD2171|
533189|NCT00243061|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
533298|NCT00242619|O1|Outcome|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
533158|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
533159|NCT00243269|O4|Outcome|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
533160|NCT00243269|O3|Outcome|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
533161|NCT00243269|O2|Outcome|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
533162|NCT00243269|O1|Outcome|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
533163|NCT00243269|E4|Reported Event|Active Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy- enhancing handout given to patients in Arm 1.~Patients received the same expectancy-enhancing CD given to patients in Arm 3."
533164|NCT00243269|E3|Reported Event|Control Handout and Active Tape.|"Patients received two acupressure bands. Patients received the same expectancy-neutral handout given to patients in Arm 1.~Patients received the same relaxation CD as patients in the control condition with additional language inserted concerning efficacy of the acupressure bands and control of nausea. This additional language is under one minute in length and intended to strengthen patients’ beliefs that the acupressure bands would be effective by focusing patients’ attention on how effective the acupressure bands have been in reducing or eliminating nausea for other patients. In addition, it was suggested that since the acupressure bands were helpful to others, they might be helpful to them as well."
533165|NCT00243269|E2|Reported Event|Active Handout and Control Tape.|"Patients received two acupressure bands.~Patients received an expectancy-enhancing handout to enhance expected acupressure band efficacy. It was printed on Cancer Center letterhead and signed by a medical oncologist and two of the study investigators. The handout presented a very positive (and truthful) interpretation of the data from two prior acupressure band studies. Patients also received a medical prescription instructing them to use the acupressure bands for relief of nausea. The prescription was signed by a medical oncologist and had the instruction, “Wear Seabands for up to five days as needed to prevent or alleviate nausea.” Patients’ names were not on the prescription.~Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed."
533166|NCT00243269|E1|Reported Event|Control Handout and Control Tape.|Patients received two acupressure bands. Patients received an expectancy-neutral handout that simply thanked them for participating in the study. The wording of the letter was, “Thank you for agreeing to participate in this study regarding the use of acupressure bands to control chemotherapy-related nausea. The information you will provide is extremely valuable. It is only with the assistance of individuals, like you, who are willing to give their time that we can learn new ways to better control the side effects of cancer treatment. Wear the acupressure bands for up to five days, if helpful, to prevent or alleviate nausea. We are very appreciative of your contribution to this study.” Patients received an expectancy-neutral relaxation CD that was about 12 minutes in length and utilized guided imagery in which the individual visualized pleasant, soothing images or scenes while relaxed.
533167|NCT00243243|B3|Baseline|Total|Total of all reporting groups
533168|NCT00243243|B2|Baseline|Control|
533169|NCT00243243|B1|Baseline|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
533170|NCT00243243|P2|Participant Flow|Control- Placebo|Intravenous infusion of a placebo
533171|NCT00243243|P1|Participant Flow|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
533172|NCT00243243|O2|Outcome|Control- Placebo|Intravenous infusion of a placebo
533173|NCT00243243|O1|Outcome|Experimental|Recombinant Factor VIIa : intravenous infusion of Factor VIIa
533174|NCT00243243|E2|Reported Event|Control|
533190|NCT00243061|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
533191|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
533192|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
533193|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
533194|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
533195|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally"
533196|NCT00243061|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
533197|NCT00243061|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive oral AZD2171 once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cediranib maleate: Given orally~laboratory biomarker analysis: Correlative studies~dynamic contrast-enhanced magnetic resonance imaging: Correlative studies"
533198|NCT00243022|B3|Baseline|Total|Total of all reporting groups
533199|NCT00243022|B2|Baseline|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533200|NCT00243022|B1|Baseline|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533201|NCT00243022|P2|Participant Flow|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/day given orally"
533202|NCT00243022|P1|Participant Flow|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533203|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533204|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533205|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533206|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533207|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533208|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533209|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533210|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533211|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533212|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533213|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533214|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533215|NCT00243022|O2|Outcome|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533295|NCT00242619|P2|Participant Flow|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
533216|NCT00243022|O1|Outcome|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533217|NCT00243022|E2|Reported Event|Arm II (Control)|"Patients in the control arm receive oral cyanocobalamin (vitamin B 12) once a day for 6 months.~cyanocobalamin : 50 ug/daygiven orally"
533218|NCT00243022|E1|Reported Event|Arm I (Intervention)|"Patients receive oral Boswellia serrata extract 4 times a day and oral cyanocobalamin (vitamin B 12) once a day for 6 months in the absence of unacceptable toxicity.~cyanocobalamin : 50 ug/day given orally~Boswellia serrata extract : 4x (3-12.5) ml/day given orally, that is 720-3000mg of total Boswellic acids (three isomers)/day"
533219|NCT00242710|B5|Baseline|Total|Total of all reporting groups
533220|NCT00242710|B4|Baseline|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533221|NCT00242710|B3|Baseline|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533222|NCT00242710|B2|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533223|NCT00242710|B1|Baseline|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533224|NCT00242710|P4|Participant Flow|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533225|NCT00242710|P3|Participant Flow|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533226|NCT00242710|P2|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533227|NCT00242710|P1|Participant Flow|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533228|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533229|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533230|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533231|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533232|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533233|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533234|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533235|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533236|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533237|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533238|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533239|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533240|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533241|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533242|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533243|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533244|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533245|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533246|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533247|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533248|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533249|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533250|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533251|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533296|NCT00242619|P1|Participant Flow|Completers|Subjects who completed the study and 12 weeks of taking rosiglitazone.
533729|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
533252|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533253|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533254|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533255|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533256|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533257|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533258|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533259|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533260|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533261|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533262|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533263|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533264|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533265|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533266|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533267|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533268|NCT00242710|O4|Outcome|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533297|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out and did not complete the 12 weeks on rosiglitazone.
533299|NCT00242619|O2|Outcome|Drop-Outs|Subjects who dropped out of the study.
533269|NCT00242710|O3|Outcome|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533270|NCT00242710|O2|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533271|NCT00242710|O1|Outcome|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533272|NCT00242710|E4|Reported Event|Placebo|Placebo matched to bazedoxifene/conjugated estrogen or conjugated estrogen/medroxyprogesterone acetate capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533273|NCT00242710|E3|Reported Event|Conjugated Estrogen 0.45 mg/Medroxyprogesterone Acetate 1.5mg|Conjugated estrogen 0.45 mg/medroxyprogesterone acetate 1.5 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533274|NCT00242710|E2|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.625 mg|Bazedoxifene 20 mg/conjugated estrogen 0.625 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 IU orally once daily up to Year 2.
533275|NCT00242710|E1|Reported Event|Bazedoxifene 20 mg/Conjugated Estrogen 0.45 mg|Bazedoxifene 20 milligram (mg)/conjugated estrogen 0.45 mg capsule orally once daily at approximately the same time each day continuously up to Year 1 during the core study and up to Year 2 during the study extension. Participants also received Caltrate plus D tablet containing calcium 600 mg and vitamin D 200 international unit (IU) orally once daily up to Year 2.
533276|NCT00242684|B1|Baseline|Transitional Care Unit Veterans|older patients admitted to a TCU unit
533277|NCT00242684|P1|Participant Flow|Transitional Care Unit Veterans|older patients admitted to a TCU unit
533278|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
533279|NCT00242684|O1|Outcome|Transitional Care Unit Veterans|older patients admitted to a TCU unit
533280|NCT00242684|E1|Reported Event|Transitional Care Unit Veterans|older patients admitted to a TCU unit
533281|NCT00242658|B3|Baseline|Total|Total of all reporting groups
533282|NCT00242658|B2|Baseline|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
533283|NCT00242658|B1|Baseline|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
533284|NCT00242658|P2|Participant Flow|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
533285|NCT00242658|P1|Participant Flow|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
533286|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
533287|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
533288|NCT00242658|O2|Outcome|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
533289|NCT00242658|O1|Outcome|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
533290|NCT00242658|E2|Reported Event|No Tailored Physical Activity Intervention Group|The control group received identical procedures, except that they received general reports on preventive screening based on their responses to preventive screening questions.
533291|NCT00242658|E1|Reported Event|Tailored Physical Activity Intervention Group|The intervention group completed physical activity surveys at baseline, 1, 3, and 6 months. Based on their responses, participants received four feedback reports at each time point. The reports aimed to motivate participants to increase physical activity, personalized to participants’ needs; they also included an activity prescription.
533292|NCT00242619|B3|Baseline|Total|Total of all reporting groups
533293|NCT00242619|B2|Baseline|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
533294|NCT00242619|B1|Baseline|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
533301|NCT00242619|E2|Reported Event|Drop-Outs|Subjects who met all criteria, took rosiglitazone, and did not complete the study.
533302|NCT00242619|E1|Reported Event|Completers|Subjects who met all criteria, took rosiglitazone, and completed the study.
533303|NCT00242580|B4|Baseline|Total|Total of all reporting groups
533304|NCT00242580|B3|Baseline|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533305|NCT00242580|B2|Baseline|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533306|NCT00242580|B1|Baseline|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533307|NCT00242580|P3|Participant Flow|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533308|NCT00242580|P2|Participant Flow|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533309|NCT00242580|P1|Participant Flow|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533310|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533311|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533312|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533313|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533314|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533315|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533316|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533317|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533318|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533319|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533320|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533321|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533322|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533323|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533324|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533325|NCT00242580|O3|Outcome|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533353|NCT00242502|E1|Reported Event|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
533420|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533730|NCT00239681|O2|Outcome|Placebo|Placebo once daily
533326|NCT00242580|O2|Outcome|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533327|NCT00242580|O1|Outcome|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533328|NCT00242580|E3|Reported Event|Verteporfin + Pegaptanib|Participants received Verteporfin photodynamic therapy and 0.3 mg Pegaptanib at the baseline visit. After the baseline visit, these participants received pegaptanib every 1.5 months up until and including the 10.5 month visit. After the baseline visit, these participants also received verteporfin at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. Starting from Month 12, if participants experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigator's discretion with available standard of care therapy.
533329|NCT00242580|E2|Reported Event|Verteporfin + 4 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 4 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 4 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533330|NCT00242580|E1|Reported Event|Verteporfin + 1 mg Triamcinolone|Participants received Verteporfin photodynamic therapy and 1 mg triamcinolone acetonide intravitreal injection at the baseline visit. After the baseline visit, these participants received Verteporfin and triamcinolone acetonide 1 mg at every 3 month visit up to Month 9 only if leakage was detected on the fluorescein angiogram. At the 1.5, 4.5, 7.5 and 10.5 month follow-up visits participants received a sham injection. Starting from Month 12, if patients experienced ≥ 10 letters vision loss from the previous visit, they were treated at the investigators' discretion with available standard of care therapy.
533331|NCT00242567|B3|Baseline|Total|Total of all reporting groups
533332|NCT00242567|B2|Baseline|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533333|NCT00242567|B1|Baseline|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533334|NCT00242567|P2|Participant Flow|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533335|NCT00242567|P1|Participant Flow|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533336|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533337|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533338|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533339|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533340|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533341|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533342|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533343|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533344|NCT00242567|O2|Outcome|Delayed Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing no sooner than 12 months after their baseline visit, and not until they have had three rises in PSA level from Baseline, one of which must be a least 10 ng/mL greater than the baseline PSA level.
533345|NCT00242567|O1|Outcome|Early Group|Zoledronic acid 4 mg i.v. infusion every 4 weeks, commencing at Baseline.
533346|NCT00242567|E4|Reported Event|Delayed Group (Zometa)|Delayed Group (Zometa)
533347|NCT00242567|E3|Reported Event|Delayed Group (No Zometa)|Delayed Group (No Zometa)
533348|NCT00242567|E2|Reported Event|Delayed Group (Overall)|Delayed Group (Overall)
533349|NCT00242567|E1|Reported Event|Early Group|Early Group
533350|NCT00242502|B1|Baseline|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
533351|NCT00242502|P1|Participant Flow|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
533352|NCT00242502|O1|Outcome|Bevacizumab + Erlotinib|Bevacizumab 10 mg/kg intravenous every 14 days, repeat cycle every 28 days; Erlotinib 150 mg orally every day continuous dosing.
533354|NCT00242385|B1|Baseline|Subjects With Severe Congenital α1-PI Deficiency|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
533355|NCT00242385|P2|Participant Flow|ARALAST Then ARALAST Fr. IV-1|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
533356|NCT00242385|P1|Participant Flow|ARALAST Fr. IV-1 Then Aralast|Subjects were randomized to receive either single dose ARALAST 60 mg/kg or single-dose ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min during the first treatment period with crossover to the alternate study product during the second treatment period, with a minimum of 7 days between the two treatment periods.
533357|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533358|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533359|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533360|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533361|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533362|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533363|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533364|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533365|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533366|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533367|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533368|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533369|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533370|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533371|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533372|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533373|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533374|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533375|NCT00242385|O2|Outcome|ARALAST|Single dose ARALAST 60 mg/kg administered at 0.2 mL/kg/min
533376|NCT00242385|O1|Outcome|ARALAST Fr. IV-1|Single-dose ARALAST Fr. IV-1 60 mg/kg administered at 0.2 mL/kg/min
533377|NCT00242385|E2|Reported Event|ARALAST|Subjects received a single dose of ARALAST 60 mg/kg at 0.2 mL/kg/min
533378|NCT00242385|E1|Reported Event|ARALAST Fr. IV-1|Subjects received a single dose of ARALAST Fr. IV-1 60 mg/kg at 0.2 mL/kg/min
533379|NCT00242216|B3|Baseline|Total|Total of all reporting groups
533380|NCT00242216|B2|Baseline|Fosamprenavir|
533381|NCT00242216|B1|Baseline|Atazanavir|
533382|NCT00242216|P2|Participant Flow|Fosamprenavir|Fosamprenavir/ritonavir (1400mg/100mg) once daily
533383|NCT00242216|P1|Participant Flow|Atazanavir|Atazanavir/ritonavir (300mg/100mg) once daily
533384|NCT00242216|O2|Outcome|Fosamprenavir|
533385|NCT00242216|O1|Outcome|Atazanavir|
533386|NCT00242216|O2|Outcome|Fosamprenavir|
533387|NCT00242216|O1|Outcome|Atazanavir|
533388|NCT00242216|E2|Reported Event|Fosamprenavir|
533389|NCT00242216|E1|Reported Event|Atazanavir|
533390|NCT00241839|B3|Baseline|Total|Total of all reporting groups
533391|NCT00241839|B2|Baseline|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533392|NCT00241839|B1|Baseline|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533393|NCT00241839|P2|Participant Flow|B(Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, a Placebo, having the same appearance and dosage label(300mg)as allopurinol, was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional placebo (300mg)was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533394|NCT00241839|P1|Participant Flow|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533418|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533419|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533731|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
533395|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533396|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533397|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533398|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533399|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533400|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533401|NCT00241839|O2|Outcome|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533402|NCT00241839|O1|Outcome|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533403|NCT00241839|E2|Reported Event|B (Placebo)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Placebo 300mg daily (identical in size, color, and dosage as allopurinol) was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg placebo was added with total dose of 600mg daily. The dosage of placebo then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533404|NCT00241839|E1|Reported Event|A (Allopurinol)|Chlorthalidone 25 mg and Potassium Chloride 40-50meq were given daily for 5 weeks before baseline visit for testing. After baseline testing was completed, Allopurinol 300mg daily was added for 8-10 weeks. Serum uric acid (UA) levels were checked at study visit 2 weeks post baseline. If UA levels were above 5.0 an additional 300mg allopurinol was added with total dose of 600mg daily. The dosage of allopurinol then remained constant throughout the remainder of the study. Testing was repeated at 8-10 weeks after baseline.
533405|NCT00241644|B5|Baseline|Total|Total of all reporting groups
533406|NCT00241644|B4|Baseline|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
533407|NCT00241644|B3|Baseline|Placebo Group|Subjects received 3 doses of placebo.
533408|NCT00241644|B2|Baseline|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533409|NCT00241644|B1|Baseline|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533410|NCT00241644|P4|Participant Flow|Rotarix Pooled Group|Subjects received 2 or 3 doses of Rotarix™ (rotavirus vaccine).
533411|NCT00241644|P3|Participant Flow|Placebo Group|Subjects received 3 doses of placebo.
533412|NCT00241644|P2|Participant Flow|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533413|NCT00241644|P1|Participant Flow|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533414|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533415|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533416|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533417|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533421|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533422|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533423|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533424|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533425|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533426|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533427|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533428|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533429|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533430|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533431|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533432|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533433|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533434|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533435|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533436|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533437|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533438|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533439|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533440|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533441|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533442|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533443|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533444|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533445|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533446|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533447|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533448|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533449|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533450|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533451|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533452|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533453|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533454|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533455|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533456|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533457|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533458|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533459|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533460|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533461|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533462|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533463|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533464|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533465|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533466|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533467|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533468|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533469|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533470|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533678|NCT00239928|P1|Participant Flow|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533471|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533472|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533473|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533474|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533475|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533476|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533477|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533478|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533479|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533480|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533481|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533482|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533483|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533484|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533485|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533486|NCT00241644|O4|Outcome|Placebo Group|Subjects received 3 doses of placebo.
533487|NCT00241644|O3|Outcome|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533488|NCT00241644|O2|Outcome|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533489|NCT00241644|O1|Outcome|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533490|NCT00241644|E4|Reported Event|Placebo Group|Subjects received 3 doses of placebo.
533491|NCT00241644|E3|Reported Event|Rotarix Pooled Group|For some data analyses, the 2 Groups receiving Rotarix (Rotarix 2-dose Group & Rotarix 3-dose Group) were pooled into Rotarix pooled Group.
533492|NCT00241644|E2|Reported Event|Rotarix 3-dose Group|Subjects received 3 doses of Rotarix™ (rotavirus vaccine).
533493|NCT00241644|E1|Reported Event|Rotarix 2-dose Group|Subjects received 1 dose of placebo followed by 2 doses of Rotarix™ (rotavirus vaccine).
533494|NCT00241280|B3|Baseline|Total|Total of all reporting groups
533495|NCT00241280|B2|Baseline|Test: Galyfilcon A|Subjects that were randomized to receive the Test lens galyfilcon A
533496|NCT00241280|B1|Baseline|Control: Etafilcon A|Subjects that were randomized to receive the Control lens etafilcon A
533497|NCT00241280|P2|Participant Flow|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
533498|NCT00241280|P1|Participant Flow|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
533499|NCT00241280|O2|Outcome|Test: Galyfilcon A|Subjects that were randomly assigned to wear the Test lens.
533500|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
533501|NCT00241280|O2|Outcome|Test: Galyfilcon A|"Subjects that were randomly assigned to wear the Test lens.~It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing."
533502|NCT00241280|O1|Outcome|Control: Etafilcon A|Subjects that were randomly assigned to wear the Control lens.
533503|NCT00241280|E2|Reported Event|Test: Galyfilcon A|Subjects that were randomly assigned to wear Test lens.
533504|NCT00241280|E1|Reported Event|Control: Etafilcon A|Subjects that were randomly assigned to wear Control lens.
533505|NCT00241176|B1|Baseline|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
533506|NCT00241176|P1|Participant Flow|Aripiprazole|Subjects received initial dose based on body weight at Visit 2: Subjects between 25-50 kg were started on 1.25 mg/day, Subjects between 50-70 kg were started on 2.5 mg/day, Subjects greater than 70 kg were started on 5 mg/day. Dosage was titrated at Visit 3, 5, 6, or 7 based on YGTSS and CGI-TS ratings at the discretion of the investigator. Subjects who showed evidence of response (reduction in CGI-TS by 1-2 points)remained on the same dose. Subjects who did not show evidence of response could be increased: Subjects between 25-50 kg were could be increased 1.25 mg/day at each titration visit, Subjects between 50-70 kg could be increased 2.5 mg/day at each titration visit, and Subjects greater than 70 kg could be increased 5 mg/day at each titration visit.
533507|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
533508|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
533509|NCT00241176|O2|Outcome|Group 1 - Endpoint|Sample of children and adolescents that enrolled in study to receive active medication at endpoint prior to down titration.
533510|NCT00241176|O1|Outcome|Group 1 - Baseline|Sample of children and adolescents that enrolled in study to receive active medication at baseline.
533511|NCT00241176|E1|Reported Event|Sample|Sample of children and adolescents that enrolled in study to receive active medication. This was not a placebo controlled study.
533512|NCT00240994|B1|Baseline|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
533585|NCT00240500|P6|Participant Flow|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533513|NCT00240994|P1|Participant Flow|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
533514|NCT00240994|O1|Outcome|Alemtuzumab (Campath)|In this open-label, single-arm trial, participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
533515|NCT00240994|E1|Reported Event|Alemtuzumab (Campath)|In this open-label, single-arm trial , participants were administered a 0.3 mg/kg dose of alemtuzumab intravenously one day prior to kidney transplantation and one day post kidney transplantation. Participants were then administered a maintenance immunosuppressive regimen of tacrolimus and mycophenolate mofetil (MMF) for 8 to 12 weeks, followed by sirolimus and MMF until 24 months post transplantation.
533516|NCT00240539|B5|Baseline|Total|Total of all reporting groups
533517|NCT00240539|B4|Baseline|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533518|NCT00240539|B3|Baseline|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533519|NCT00240539|B2|Baseline|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533520|NCT00240539|B1|Baseline|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533521|NCT00240539|P4|Participant Flow|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533522|NCT00240539|P3|Participant Flow|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533523|NCT00240539|P2|Participant Flow|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533524|NCT00240539|P1|Participant Flow|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533525|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533526|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533527|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533528|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533529|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533530|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533531|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533532|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533533|NCT00240539|O4|Outcome|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533534|NCT00240539|O3|Outcome|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533535|NCT00240539|O2|Outcome|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533536|NCT00240539|O1|Outcome|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533537|NCT00240539|E4|Reported Event|HBsAg(-) & HBeAg(-) 4-dose Group|Newborns of HBsAg(-) and HBeAg(-) mothers, who received 4 doses of Engerix™ in the primary study.
533538|NCT00240539|E3|Reported Event|HBsAg(+) & HBeAg(+) 4-dose Group|Newborns of HBsAg(+) and HBeAg(+) mothers, who received 4 doses of Engerix™ in the primary study.
533539|NCT00240539|E2|Reported Event|HBsAg(+) & HBeAg(-) 4-dose Group|Newborns of HBsAg(+) and HBeAg negative [HBeAg(-)] mothers, who received 4 doses of Engerix™ in the primary study.
533540|NCT00240539|E1|Reported Event|HBsAg(+) & HBeAg(+) 5-dose Group|Newborns of anti-hepatitis B surface antigen positive [HBsAg(+)] and hepatitis B envelope antigen positive [HBeAg(+)] mothers, who received 5 doses of Engerix™ in the primary study.
533541|NCT00240526|B5|Baseline|Total|Total of all reporting groups
533542|NCT00240526|B4|Baseline|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533543|NCT00240526|B3|Baseline|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533544|NCT00240526|B2|Baseline|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533545|NCT00240526|B1|Baseline|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533546|NCT00240526|P4|Participant Flow|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533547|NCT00240526|P3|Participant Flow|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533548|NCT00240526|P2|Participant Flow|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533549|NCT00240526|P1|Participant Flow|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533550|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533551|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533552|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533553|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533554|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533555|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533556|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533557|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533558|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533559|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533560|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533561|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533562|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533563|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533564|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533565|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533566|NCT00240526|O4|Outcome|ENGERIX 3D GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533567|NCT00240526|O3|Outcome|ENGERIX 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533568|NCT00240526|O2|Outcome|ENGERIX 3D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533569|NCT00240526|O1|Outcome|ENGERIX 4D + HBIG GROUP|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533570|NCT00240526|O4|Outcome|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533571|NCT00240526|O3|Outcome|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533572|NCT00240526|O2|Outcome|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533573|NCT00240526|O1|Outcome|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533574|NCT00240526|E4|Reported Event|Engerix 3D Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6
533575|NCT00240526|E3|Reported Event|Engerix 4D|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60.
533576|NCT00240526|E2|Reported Event|Engerix 3D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, and 6 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533577|NCT00240526|E1|Reported Event|Engerix 4D + HBIg Group|Subjects received Engerix™ (hepatitis B vaccine [HBV]) at Month 0, 1, 6 and 60 with hepatitis B immunoglobulins (HBIg) administered concomitantly at birth in the opposite arm.
533578|NCT00240500|B7|Baseline|Total|Total of all reporting groups
533579|NCT00240500|B6|Baseline|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533580|NCT00240500|B5|Baseline|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533581|NCT00240500|B4|Baseline|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533582|NCT00240500|B3|Baseline|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533583|NCT00240500|B2|Baseline|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533584|NCT00240500|B1|Baseline|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533586|NCT00240500|P5|Participant Flow|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533587|NCT00240500|P4|Participant Flow|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533588|NCT00240500|P3|Participant Flow|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533589|NCT00240500|P2|Participant Flow|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533590|NCT00240500|P1|Participant Flow|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533591|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533592|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533593|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533594|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533595|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533596|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533597|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533598|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533599|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533600|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533601|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533602|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533603|NCT00240500|O6|Outcome|HBV 6 Group|neonates born to HBsAg- and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533604|NCT00240500|O5|Outcome|HBV 3 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533605|NCT00240500|O4|Outcome|HBV 4 Group|neonates born to HBsAg+ and HBeAg- mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533606|NCT00240500|O3|Outcome|HBV 1 Group|neonates born to HBsAg+ and HBeAg+ mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533607|NCT00240500|O2|Outcome|HBV 2 Group|neonates born to Hepatitis B surface antigen positive (HBsAg+) and Hepatitis B e antigen positive (HBeAg+) mothers who received a 4-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12)
533608|NCT00240500|O1|Outcome|HBV 5 Group|neonates born to Hepatitis B surface antigen negative (HBsAg-) and Hepatitis B e antigen negative (HBeAg-) mothers who received a 5-dose vaccination regimen (0, 1 and 2-month schedule with a booster dose at Month 12 and again a booster dose at Month 60)
533609|NCT00240487|B3|Baseline|Total|Total of all reporting groups
533610|NCT00240487|B2|Baseline|Delayed Nitric Oxide|Subjects received no intervention (no nitric oxide) for the first 4 hours of study participation. After which, they received 10 ppm nitric oxide for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
533611|NCT00240487|B1|Baseline|Nitric Oxide First|Subjects received 10 ppm nitric oxide for the first 4 hours of study participation After which, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. After the initial 8 hours of study participation, subjects will remain on whichever intervention (no nitric oxide versus 10 ppm nitric oxide) they responded best to.
533612|NCT00240487|P2|Participant Flow|Delayed Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
533676|NCT00240071|E1|Reported Event|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
533677|NCT00239928|B1|Baseline|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533732|NCT00239681|O2|Outcome|Placebo|Placebo once daily
533613|NCT00240487|P1|Participant Flow|Nitric Oxide First|Subjects who were randomized to receive Nitric Oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the initial 8 hours of study participation, subjects remained on whichever intervention (no intervention versus 10 ppm nitric oxide) they responded best to.
533614|NCT00240487|O2|Outcome|Delayed Nitric Oxide Treatment|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
533615|NCT00240487|O1|Outcome|Immediate Nitric Oxide Treatment|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received treatment standard clinical care. Blood gases were monitored once an hour for 4 hours.
533616|NCT00240487|E2|Reported Event|Delayed Treatment With Nitric Oxide|Subjects who were randomized to receive delayed treatment with Nitric Oxide (NO) began the first 4 hours of study participation receiving no intervention (no nitric oxide). During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the NO was turned on and subjects received 10 ppm of nitric oxide for the next 4 hours of study participation. Blood gases were monitored once an hour for 4 hours.
533617|NCT00240487|E1|Reported Event|Immediate Treatment With Nitric Oxide|Subjects who were randomized to receive immediate treatment with nitric oxide (NO) began receiving NO immediately after study entry, given at 10 parts per million (ppm) for the first 4 hours of study participation. Blood gases were monitored once an hour for 4 hours. After the first four hours of study participation, the nitric oxide (NO) was turned off and subjects received no intervention (no nitric oxide) for the next 4 hours of study participation. During this time, all subjects received standard clinical care. Blood gases were monitored once an hour for 4 hours.
533618|NCT00240331|B3|Baseline|Total|Total of all reporting groups
533619|NCT00240331|B2|Baseline|Placebo|Matching placebo
533620|NCT00240331|B1|Baseline|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533621|NCT00240331|P2|Participant Flow|Placebo|Matching placebo
533622|NCT00240331|P1|Participant Flow|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533623|NCT00240331|O2|Outcome|Placebo|Matching placebo
533624|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533625|NCT00240331|O2|Outcome|Placebo|Matching placebo
533626|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533627|NCT00240331|O2|Outcome|Placebo|Matching placebo
533628|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533629|NCT00240331|O2|Outcome|Placebo|Matching placebo
533630|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533631|NCT00240331|O2|Outcome|Placebo|Matching placebo
533632|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533633|NCT00240331|O2|Outcome|Placebo|Matching placebo
533634|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533635|NCT00240331|O2|Outcome|Placebo|Matching placebo
533636|NCT00240331|O1|Outcome|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533637|NCT00240331|E2|Reported Event|Placebo|Matching placebo
533638|NCT00240331|E1|Reported Event|Rosuvastatin 10mg|Rosuvastatin 10 mg oral tablets
533639|NCT00240227|B1|Baseline|All Study Paricipants|"Placebo no active medication~placebo~Prazosin~FDA approved medication for hypertension"
533640|NCT00240227|P1|Participant Flow|All Study Participants|"Placebo no active medication~placebo~Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
533641|NCT00240227|O2|Outcome|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
533642|NCT00240227|O1|Outcome|Placebo|"Placebo no active medication~placebo"
533643|NCT00240227|E2|Reported Event|Prazosin|"Prazosin flexible dose titration up to 12 mg per day.~Prazosin: FDA approved medication for hypertension"
533644|NCT00240227|E1|Reported Event|Placebo|"Placebo no active medication~placebo"
533645|NCT00240162|B1|Baseline|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533646|NCT00240162|P1|Participant Flow|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533647|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533717|NCT00239720|E2|Reported Event|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
533648|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533649|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533650|NCT00240162|O1|Outcome|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533651|NCT00240162|E1|Reported Event|PTK787/ZK 222584|Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
533652|NCT00240110|B3|Baseline|Total|Total of all reporting groups
533653|NCT00240110|B2|Baseline|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
533654|NCT00240110|B1|Baseline|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
533655|NCT00240110|P2|Participant Flow|Lithium Carbonate Add on Valproate|Lithium carbonate started and participants randomized to valproate
533656|NCT00240110|P1|Participant Flow|Lithium Carbonate Add on Placebo|Lithium started and then participants randomized to placebo
533657|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Open label lithium carbonate as standard treatment and double blinded valproate
533658|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Open label lithium carbonate as standard treatment and double blinded placebo
533659|NCT00240110|O2|Outcome|Lithium Carbonate Add on Valproate|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to valproate
533660|NCT00240110|O1|Outcome|Lithium Carbonate Add on Placebo|Lithium carbonate started with titration to achieve blood levels within the therapeutic range and then participants randomized to placebo
533661|NCT00240110|E2|Reported Event|Lithium Carbonate Add on Valproate|Lithium carbonate as standard treatment add on double blind valproate
533662|NCT00240110|E1|Reported Event|Lithium Carbonate Add on Placebo|Lithium carbonate as standard treatment add on double blind placebo
533663|NCT00240097|B1|Baseline|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks.
533664|NCT00240097|P1|Participant Flow|Regimen A and B|"Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)~Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)"
533665|NCT00240097|O1|Outcome|Part II - After Relapse|Study dosing with A and B based on relapse
533666|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
533667|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
533668|NCT00240097|O1|Outcome|Regimen A and B|Chemotherapy-naive patients with extensive SCLC will be treated in one of two regimens: Regimen A consists of treatment with irinotecan and oxaliplatin given every 2 weeks while Regimen B consists of etoposide and carboplatin given every 3 weeks. Both regimens will include re-evaluation for response at least every 8 weeks
533669|NCT00240097|E4|Reported Event|Regimen B Overall Toxicity|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
533670|NCT00240097|E3|Reported Event|Regimen A Overall Toxicity|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
533671|NCT00240097|E2|Reported Event|Regimen B First Cycle|Regimen B Etoposide (I.V.) 100 mg/m2; Day 1, 2, 3 (every 5 weeks) Carboplatin (I.V.) AUC 6; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 4 (every 5 weeks)
533672|NCT00240097|E1|Reported Event|Regimen A First Cycle|Regimen A Irinotecan (I.V.) 150-200 mg/m2; Day 1 (every 5 weeks) Oxaliplatin (I.V.) 85 mg/m2; Day 1 (every 5 weeks) Neulasta (subcutaneous) 6 mg; Day 1 (every 5 weeks)
533673|NCT00240071|B1|Baseline|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
533674|NCT00240071|P1|Participant Flow|Avastin(Bevacizumab) Plus Hormonal Therapy|Avastin (Bevacizumab)15mg/m2 IV every 3 weeks plus various daily oral hormonal therapies.
533675|NCT00240071|O1|Outcome|Avastin (Bevacizumab) Plus Hormone|All patients received Avastin (Bevacizumab) 15 mg/kg IV every three weeks as well as continuing with hormonal therapy they previously were taking.
533679|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533680|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533681|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533682|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533683|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533684|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533685|NCT00239928|O1|Outcome|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533686|NCT00239928|E1|Reported Event|EYE001|All subjects received a 0.3 mg/eye EYE001 intravitreal injection every 6 weeks from Week 54 up to Week 198.
533687|NCT00239837|B3|Baseline|Total|Total of all reporting groups
533688|NCT00239837|B2|Baseline|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533689|NCT00239837|B1|Baseline|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533690|NCT00239837|P2|Participant Flow|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533691|NCT00239837|P1|Participant Flow|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533692|NCT00239837|O2|Outcome|Foster Care Services as Usual|Foster Care Services as Usual: Participants continue with usual foster care
533693|NCT00239837|O1|Outcome|Middle School Success Intervention (MSS)|"Middle School Success Intervention (MSS): Participants receive the preventative intervention~Middle School Success Intervention (MSS): This is a 10-month, psychosocial intervention for foster parents and girls, with administration of the intervention beginning the summer before entry into middle school. The intervention consists of: (1) six summer Pride groups for the girls, (2) six summer parenting intervention sessions for the foster parents; (3) weekly foster parent training and support sessions for foster parents during the first year of middle school; and (4) weekly individual skills training for the girls during the first year of middle school."
533694|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533718|NCT00239720|E1|Reported Event|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
533719|NCT00239681|B3|Baseline|Total|Total of all reporting groups
533720|NCT00239681|B2|Baseline|Placebo|Placebo once daily
533721|NCT00239681|B1|Baseline|Rosuvastatin|Rosuvastatin 20 mg once daily
533722|NCT00239681|P2|Participant Flow|Placebo|Placebo once daily
533723|NCT00239681|P1|Participant Flow|Rosuvastatin|Rosuvastatin 20 mg once daily
533695|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533696|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533697|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533698|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533699|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533700|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533701|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533702|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533703|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533704|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533705|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533706|NCT00239837|O2|Outcome|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533707|NCT00239837|O1|Outcome|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533708|NCT00239837|E2|Reported Event|2 - Foster Care Services as Usual|The girls and caregivers in the control condition received the usual services provided by the child welfare system, including services such as referrals to individual or family therapy, parenting classes for biological parents, and case monitoring. Of the girls in the control condition, 62% received individual counseling, 20% received family counseling, 22% received group counseling, 30% received mentoring, 37% received psychiatric support, and 40% received other counseling or therapy services (e.g., school counseling, academic support) during the first year of middle school. Note that many girls received more than one service, and therefore the percentages listed above exceed 100%. Child Welfare caseworkers managed each case and were responsible for making all decisions on referrals to community resources, including individual and family therapy and parenting classes.
533709|NCT00239837|E1|Reported Event|1 - Intervention|Participants receive the preventative intervention. The intervention consisted of two primary components: (a) six sessions of group-based caregiver management training for the foster parents and (b) six sessions of group-based skill-building sessions for the girls. The groups met twice a week for 3 weeks, with approximately seven participants in each group. The caregiver sessions were led by one facilitator and one cofacilitator. The girl sessions were led by one facilitator and three assistants to allow a high staff-to-girl ratio (1:2) for individualized attention, one-on-one modeling/practicing of new skills, and frequent reinforcement of positive behaviors. In addition to the summer group sessions, follow-up intervention services (i.e., ongoing training and support) were provided to the caregivers and girls in the intervention group once a week for 2 hr (foster parent meeting; one-on-one session for girls) during the first year of middle school.
533710|NCT00239720|B3|Baseline|Total|Total of all reporting groups
533711|NCT00239720|B2|Baseline|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
533712|NCT00239720|B1|Baseline|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
533713|NCT00239720|P2|Participant Flow|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
533714|NCT00239720|P1|Participant Flow|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
533715|NCT00239720|O2|Outcome|Placebo|Intravenous dose of placebo given over 5 days of each 28 day cycle
533716|NCT00239720|O1|Outcome|hOKT3gamma1 (Ala-Ala)|Escalating dose of hOKT3gamma1 (Ala-Ala) given intravenously over 5 days of each 28 day cycle
533733|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
533734|NCT00239681|O2|Outcome|Placebo|Placebo once daily
533735|NCT00239681|O1|Outcome|Rosuvastatin|Rosuvastatin 20 mg once daily
533736|NCT00239681|E2|Reported Event|ROSUVASTATIN 20 MG|
533737|NCT00239681|E1|Reported Event|PLACEBO|
533738|NCT00239642|B4|Baseline|Total|Total of all reporting groups
533739|NCT00239642|B3|Baseline|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533740|NCT00239642|B2|Baseline|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533741|NCT00239642|B1|Baseline|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533742|NCT00239642|P3|Participant Flow|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533743|NCT00239642|P2|Participant Flow|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533744|NCT00239642|P1|Participant Flow|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533745|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533746|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533747|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533748|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533749|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533750|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533751|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533752|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533753|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533754|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533755|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533756|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533757|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533758|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533759|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533760|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533761|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533762|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533763|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533764|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533765|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533766|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533767|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533768|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533769|NCT00239642|O3|Outcome|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533770|NCT00239642|O2|Outcome|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533771|NCT00239642|O1|Outcome|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533772|NCT00239642|E3|Reported Event|Venofer (2.0 mg/kg)|2.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533773|NCT00239642|E2|Reported Event|Venofer (1.0 mg/kg)|1.0 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533774|NCT00239642|E1|Reported Event|Venofer (0.5 mg/kg)|0.5 mg/kg of Venofer (iron sucrose) up to 100 mg administered intravenously
533775|NCT00239356|B3|Baseline|Total|Total of all reporting groups
533776|NCT00239356|B2|Baseline|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533777|NCT00239356|B1|Baseline|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533778|NCT00239356|P2|Participant Flow|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533779|NCT00239356|P1|Participant Flow|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533780|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533781|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533782|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533783|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533784|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533785|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533786|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533787|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533788|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533789|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533790|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533791|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533792|NCT00239356|O2|Outcome|Aripiprazole 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533793|NCT00239356|O1|Outcome|Aripiprazole 10 - 30 mg Once Daily (QD)|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533794|NCT00239356|E2|Reported Event|Schizophrenia 10 - 30 mg QD|Aripiprazole for schizophrenic participants: Tablets, Oral, 10 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533795|NCT00239356|E1|Reported Event|Bipolar I Disorder 5 - 30 mg QD|Aripiprazole for Bipolar I Disorder participants: Tablets, Oral, 5 - 30 mg, once daily, greater than 52 weeks depending upon Aripiprazole approval in respective country.
533796|NCT00239226|B5|Baseline|Total|Total of all reporting groups
533797|NCT00239226|B4|Baseline|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
533798|NCT00239226|B3|Baseline|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
533799|NCT00239226|B2|Baseline|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
533800|NCT00239226|B1|Baseline|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
533801|NCT00239226|P4|Participant Flow|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
533802|NCT00239226|P3|Participant Flow|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
533803|NCT00239226|P2|Participant Flow|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
533804|NCT00239226|P1|Participant Flow|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
533805|NCT00239226|O4|Outcome|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
533806|NCT00239226|O3|Outcome|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
533807|NCT00239226|O2|Outcome|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
533808|NCT00239226|O1|Outcome|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
533809|NCT00239226|E4|Reported Event|RAA Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to right atrial appendage (RAA) pacing.
533810|NCT00239226|E3|Reported Event|RAA Pacing Study Group|Patients with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to right atrial appendage (RAA) pacing.
533811|NCT00239226|E2|Reported Event|IAS Pacing Control Group|Patients without severe conduction delay (Delta CTos <50 ms, Control Group) randomized to interatrial septum (IAS) pacing.
533812|NCT00239226|E1|Reported Event|IAS Pacing Study Group|Patients with with severe conduction delay (Delta CTos >50 ms, Study Group) randomized to interatrial septum (IAS) pacing.
533813|NCT00239005|B3|Baseline|Total|Total of all reporting groups
533814|NCT00239005|B2|Baseline|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533815|NCT00239005|B1|Baseline|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
533816|NCT00239005|P2|Participant Flow|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533817|NCT00239005|P1|Participant Flow|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
534014|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534015|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
533818|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533819|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
533820|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533821|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
533822|NCT00239005|O2|Outcome|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533823|NCT00239005|O1|Outcome|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
533824|NCT00239005|E2|Reported Event|Mycophenolate Mofetil (MMF)|250 mg capsules or 500 mg tablets of mycophenolate mofetil. Daily dose decided by physician, was taken morning and evening.
533825|NCT00239005|E1|Reported Event|Enteric-Coated Mycophenolate Sodium (EC-MPS)|Oral film-coated gastroresistant tablets containing 360mg or 180mg of mycophenolate sodium. Daily dose decided by the physician, was taken morning and evening.
533826|NCT00238615|B1|Baseline|Group 1|
533827|NCT00238615|P1|Participant Flow|Docetaxel / Carboplatin / XRT + Surgical Resection|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival outcomes.
533828|NCT00238615|O1|Outcome|Docetaxel+Carboplatin +Radiation+Surgery|Patients were treated on this prospective phase II trial of trimodality therapy. Induction treatment consisted of weekly docetaxel 20 mg/m2 and weekly carboplatin at an area under curve (AUC) of 2 concurrent with 45 Gy thoracic radiotherapy. Resection was performed unless felt to be unsafe or if patients had progressive disease. Postoperative consolidation consisted of docetaxel 75 mg/m2 and carboplatin at an AUC of 6 every 3 weeks for 3 cycles with growth factor support. Patients were followed for survival and progression free survival outcomes.These results are published PMID: 21752720.
533829|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|This planned analysis of gene expression patterns was not performed.
533830|NCT00238615|O1|Outcome|Docetaxel / Carboplatin / XRT + Surgical Resection|"All patients enrolled had combined chemotherapy/radiation followed by surgical resection (other than 1 patient who had only chemotherapy/radiation) and were evaluated for a primary endpoint of 2 year overall survival. PET scans obtained pre and post 5 weeks of combined therapy were analyzed for predictive capacity relative to this endpoint.~Results were published PMID 21774104"
533831|NCT00238615|E1|Reported Event|Docetaxel / Carboplatin / XRT + Surgical Resection|Adverse events for all enrolled patients were followed. Details are published in PMID: 21752720
533832|NCT00238420|B3|Baseline|Total|Total of all reporting groups
533833|NCT00238420|B2|Baseline|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533834|NCT00238420|B1|Baseline|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533835|NCT00238420|P2|Participant Flow|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533836|NCT00238420|P1|Participant Flow|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533837|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533838|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533839|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533840|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533841|NCT00238420|O2|Outcome|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533842|NCT00238420|O1|Outcome|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533843|NCT00238420|E2|Reported Event|HER2- :RT and Paclitaxel|Paclitaxel chemotherapy concurrent with radiation therapy
533844|NCT00238420|E1|Reported Event|HER2+ :RT, Paclitaxel, and Trastuzumab|Paclitaxel and trastuzumab chemotherapy with concurrent with radiation therapy
533845|NCT00238355|B1|Baseline|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
533846|NCT00238355|P1|Participant Flow|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
533847|NCT00238355|O1|Outcome|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
533848|NCT00238355|E1|Reported Event|Voriconazole Plus Caspofungin|"Voriconazole: 6mg/kg iv q12 hours x 2 doses OR 400mg po q12hours on day 1 (loading doses). Maintenance doses on day 2 through day 84 may be either 4 mg/kg iv q12 hours, or 200 mg po q12 hours~Caspofungin: 70 mg iv x 1 on day 1 (loading dose), followed by 50 mg iv daily on day 2 through day 84."
533849|NCT00238303|B4|Baseline|Total|Total of all reporting groups
534016|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534017|NCT00237666|E1|Reported Event|Ziprasidone|
533850|NCT00238303|B3|Baseline|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533851|NCT00238303|B2|Baseline|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533852|NCT00238303|B1|Baseline|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533853|NCT00238303|P3|Participant Flow|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533854|NCT00238303|P2|Participant Flow|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533855|NCT00238303|P1|Participant Flow|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533856|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533857|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533858|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533859|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533860|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533861|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533862|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533863|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533864|NCT00238303|O1|Outcome|Stratum 1 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533865|NCT00238303|O3|Outcome|Stratum 3 (Not Undergoing Surgery)|"Patients not receiving pre-surgery SAHA with ≥2 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533866|NCT00238303|O2|Outcome|Stratum 2 (Undergoing Surgery)|"Beginning 3 days prior to surgery, patients receive oral vorinostat (SAHA) once or twice daily for a total of 6 doses. Patients then undergo surgery to remove the tumor. Beginning within 1-4 weeks after surgery, patients receive oral SAHA twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.~surgery : Patients undergo surgery to remove tumor"
533867|NCT00238303|O1|Outcome|Stratum 1 Patients That Started Treatment|"Patients not receiving pre-surgery SAHA with ≤1 prior chemotherapy regimens for progressive/recurrent disease. Patients receive oral vorinostat (SAHA) twice daily for 2 weeks. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.~vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest."
533868|NCT00238303|E3|Reported Event|Stratum 3 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
533869|NCT00238303|E2|Reported Event|Stratum 2 (Undergoing Surgery)|surgery : Patients undergo surgery to remove tumor
533870|NCT00238303|E1|Reported Event|Stratum 1 (Not Undergoing Surgery)|vorinostat : Given orally, 200 milligrams two times a day for 14 days followed by 7 days rest.
533871|NCT00238238|B4|Baseline|Total|Total of all reporting groups
533872|NCT00238238|B3|Baseline|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
533873|NCT00238238|B2|Baseline|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
533874|NCT00238238|B1|Baseline|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
533875|NCT00238238|P3|Participant Flow|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
533876|NCT00238238|P2|Participant Flow|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
533877|NCT00238238|P1|Participant Flow|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
533878|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
533879|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
533880|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
533881|NCT00238238|O3|Outcome|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
533882|NCT00238238|O2|Outcome|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
533883|NCT00238238|O1|Outcome|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
533884|NCT00238238|E3|Reported Event|Arm III - Lenalidomide and Rituximab|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12 Patients also receive rituximab 375 mg/m^2 IV on days 8, 15, 22 and 29.
533885|NCT00238238|E2|Reported Event|Arm II - Lenalidomide|Patients receive oral lenalidomide 15 mg once daily on days 1-21 in cycle 1, then 20 mg once daily on days 1-21 cycle 2-12. Treatment repeats every 28 days.
533886|NCT00238238|E1|Reported Event|Arm I - Rituximab|Patients receive rituximab 375 mg/m^2 IV on days 1, 8, 15, and 22.
533887|NCT00238121|B3|Baseline|Total|Total of all reporting groups
533888|NCT00238121|B2|Baseline|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533889|NCT00238121|B1|Baseline|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533890|NCT00238121|P2|Participant Flow|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533891|NCT00238121|P1|Participant Flow|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533892|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533893|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533894|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533895|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533896|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533897|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
534197|NCT00236080|B4|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
533898|NCT00238121|O2|Outcome|Carcinosarcoma|Patients with advanced uterine carcinosarcoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533899|NCT00238121|O1|Outcome|Carcinoma|Patients with advanced uterine carcinoma receive 400 mg oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
533900|NCT00238121|E1|Reported Event|Sorafenib|
533901|NCT00238108|B3|Baseline|Total|Total of all reporting groups
533902|NCT00238108|B2|Baseline|Placebo|Placebo
533903|NCT00238108|B1|Baseline|Melatonin|Melatonin
533904|NCT00238108|P2|Participant Flow|Placebo|Placebo
533905|NCT00238108|P1|Participant Flow|Melatonin|Melatonin
533906|NCT00238108|O2|Outcome|Placebo|Placebo
533907|NCT00238108|O1|Outcome|Melatonin|Melatonin
533908|NCT00238108|E2|Reported Event|Placebo|Placebo
533909|NCT00238108|E1|Reported Event|Melatonin|Melatonin
533910|NCT00237796|B3|Baseline|Total|Total of all reporting groups
533911|NCT00237796|B2|Baseline|Goal Focused Supportive Contact (GFSC)|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533912|NCT00237796|B1|Baseline|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533913|NCT00237796|P2|Participant Flow|Goal Focused Supportive Contact (GFSC)|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533914|NCT00237796|P1|Participant Flow|Cognitive Behavioral Social Skills Training (CBSST)|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533915|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533916|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533917|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533918|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533919|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533920|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533921|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533922|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533923|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533924|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533925|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533926|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533927|NCT00237796|O2|Outcome|Goal Focused Supportive Contact|"Goal Focused Supportive Contact~Goal Focused Supportive Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months."
533928|NCT00237796|O1|Outcome|Cognitive Behavioral Social Skills Training|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533929|NCT00237796|E2|Reported Event|Goal Directed Supportive Care|Goal Directed Supportive Care Contact: Active goal setting and supportive contact in group therapy 2 hours per week for 9 months.
533930|NCT00237796|E1|Reported Event|CBSST|Cognitive Behavioral Social Skills Training: Thought challenging, social communication skills, and problem solving skills are trained in group therapy 2 hours per week for 9 months.
533931|NCT00237770|B3|Baseline|Total|Total of all reporting groups
533932|NCT00237770|B2|Baseline|Able-bodied Controls|Systolic blood pressure responses to head-up tilt were determined in able-bodied controls following placebo administration
533933|NCT00237770|B1|Baseline|Individuals With Tetraplegia|Systolic blood pressure responses to head-up tilt were determined after placebo, L-NAME (1.0 mg/kg) and L-NAME administration (2.0 mg/kg) administration.
533934|NCT00237770|P2|Participant Flow|Control Subjects|Systolic blood pressure responses to head-up tilt were determined in non-spinal cord injured control subjects following placebo administration. Control subjects visited the laboratory for 1 visit.
533935|NCT00237770|P1|Participant Flow|Tetraplegic Subjects|All tetraplegic subjects underwent a head-up tilt maneuver to determine systolic blood pressure responses to placebo L-NAME 1.0 mg/kg and L-NAME 2.0 mg/kg. Subjects with tetraplegia visited the laboratory on 3 separate occasions.
533936|NCT00237770|O4|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
534198|NCT00236080|B3|Baseline|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
533937|NCT00237770|O3|Outcome|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
533938|NCT00237770|O2|Outcome|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
533939|NCT00237770|O1|Outcome|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
533940|NCT00237770|E4|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 2.0 mg|Systolic blood pressure responses during head-up tilt were determined following L-NAME administration (2.0 mg/kg)
533941|NCT00237770|E3|Reported Event|Tetraplegic Systolic Blood Pressure Responses to L-NAME 1.0 mg|Systolic blood pressure responses to head-up tilt were determined following administration of L-NAME (1.0 mg/kg)
533942|NCT00237770|E2|Reported Event|Control Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined in non spinal cord injured controls following placebo administration
533943|NCT00237770|E1|Reported Event|Tetraplegic Systolic Blood Pressure Responses to Placebo|Systolic blood pressure responses to head-up tilt were determined after placebo administration in persons with tetraplegia
533944|NCT00237744|B4|Baseline|Total|Total of all reporting groups
533945|NCT00237744|B3|Baseline|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow=wrist hand
533946|NCT00237744|B2|Baseline|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist hand >shoulder/elbow
533947|NCT00237744|B1|Baseline|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
533948|NCT00237744|P3|Participant Flow|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
533949|NCT00237744|P2|Participant Flow|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
533950|NCT00237744|P1|Participant Flow|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
533951|NCT00237744|O3|Outcome|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning.
533952|NCT00237744|O2|Outcome|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
533953|NCT00237744|O1|Outcome|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and wrist/hand FES.
533954|NCT00237744|O3|Outcome|Whole Arm Motor Learning Group|Interventions included whole arm motor learning, FES and Robotics.
533955|NCT00237744|O2|Outcome|Wrist/Hand FES+Whole Arm Motor Learning|The intervention provided in this group included surface FES and whole are motor learning.
533956|NCT00237744|O1|Outcome|Shoulder/Elbow Robotics+Whole Arm Motor Learning|Subjects>6 months following first stroke with diminished upper limb strength, coordination and function, who received whole arm motor learning and shoulder/elbow robotics.
533957|NCT00237744|E3|Reported Event|Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow = wrist hand.
533958|NCT00237744|E2|Reported Event|Shoulder/Elbow Robotics + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of shoulder/elbow > wrist hand.
533959|NCT00237744|E1|Reported Event|Wrist/Hand FES + Whole Arm Motor Learning|Subjects > 6 months following first stroke with diminished upper limb strength, coordination and function, and impairment of wrist/hand> shoulder/elbow.)
533960|NCT00237718|B3|Baseline|Total|Total of all reporting groups
533961|NCT00237718|B2|Baseline|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
533962|NCT00237718|B1|Baseline|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
533963|NCT00237718|P2|Participant Flow|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
533964|NCT00237718|P1|Participant Flow|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
533965|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
533966|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
533967|NCT00237718|O2|Outcome|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
533968|NCT00237718|O1|Outcome|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
533969|NCT00237718|E2|Reported Event|Placebo|placebo for ALA (2 pills) and for Vitamin E (1 pill) taken orally on a daily basis for 6 months
533970|NCT00237718|E1|Reported Event|ALA and Vitamin E|600 mg (2 pills 300 mg each) of alpha lipoic acid (ALA) and 666 IU (1 pill) of mixed (alpha, gamma, beta and delta) tocopherols (Vitamin E) taken orally on a daily basis for 6 months
533971|NCT00237692|B5|Baseline|Total|Total of all reporting groups
534199|NCT00236080|B2|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
533972|NCT00237692|B4|Baseline|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533973|NCT00237692|B3|Baseline|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533974|NCT00237692|B2|Baseline|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533975|NCT00237692|B1|Baseline|Arm 1- Control|A group of hypertensive patients who receive usual care
533976|NCT00237692|P4|Participant Flow|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533977|NCT00237692|P3|Participant Flow|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533978|NCT00237692|P2|Participant Flow|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533979|NCT00237692|P1|Participant Flow|Arm 1- Control|A group of hypertensive patients who receive usual care
533980|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533981|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533982|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533983|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
533984|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533985|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533986|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533987|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
533988|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533989|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533990|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533991|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
533992|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533993|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533994|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533995|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
533996|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
533997|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
533998|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
533999|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
534000|NCT00237692|O4|Outcome|Arm 4 - Combined Behaviorial and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
534001|NCT00237692|O3|Outcome|Arm 3 - Nurse Med Management Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
534002|NCT00237692|O2|Outcome|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
534003|NCT00237692|O1|Outcome|Arm 1- Control|a group of hypertensive patients who receive usual care
534004|NCT00237692|E4|Reported Event|Arm 4 - Combined Behavioral and Med Mgmt Int|Nurse Combined intervention with Home BP Telemonitoring: Combination of the nurse administered tailored behavioral & medication management
534005|NCT00237692|E3|Reported Event|Arm 3 - Nurse Med Managment Int|Nurse Medication Management with Home BP Telemonitoring: Nurse administer medication management according to hypertension decision support
534006|NCT00237692|E2|Reported Event|Arm 2 - Nurse Behavioral Int|Nurse Behavioral intervention with Home BP Telemonitoring: Nurse-administered behavior intervention
534007|NCT00237692|E1|Reported Event|Arm 1- Control|A group of hypertensive patients who receive usual care
534008|NCT00237666|B1|Baseline|Ziprasidone|
534009|NCT00237666|P1|Participant Flow|Ziprasidone|Patients will receive 8 weeks of active treatment with ziprasidone, initiated at 20mg BID. Depending on tolerability and clinical response, the dosage can be titrated up to a maximum of 60mg BID per day. Dosage can be lowered or temporarily stopped if necessary because of adverse events.
534010|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534011|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534012|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534013|NCT00237666|O1|Outcome|Ziprasidone|Ziprasidone 20-60 mg BID
534018|NCT00237458|B1|Baseline|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534019|NCT00237458|P1|Participant Flow|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534020|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534021|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534022|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534023|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534024|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534025|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534026|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534027|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534028|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534029|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534030|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534031|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534032|NCT00237458|O1|Outcome|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534033|NCT00237458|E1|Reported Event|Lacosamide|Dosage: Lacosamide up to 400 mg/day; Dosage form: Film-coated tablets; Dosage Frequency and Duration: Two times per day; 9.5 years
534034|NCT00237185|B3|Baseline|Total|Total of all reporting groups
534035|NCT00237185|B2|Baseline|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534036|NCT00237185|B1|Baseline|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534037|NCT00237185|P2|Participant Flow|Imatinib Mesylate 600 mg|imatinib mesylate 600 mg once daily
534038|NCT00237185|P1|Participant Flow|Imatinib Mesylate 400 mg|imatinib mesylate 400 mg once daily
534039|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534040|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534041|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534042|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534043|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534044|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534045|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534046|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534047|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534048|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534049|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534050|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534051|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534052|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534053|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534054|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534055|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534056|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534057|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534058|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534059|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534060|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534061|NCT00237185|O2|Outcome|Imatinib Mesylate 600 mg|"600 mg~Imatinib mesylate"
534062|NCT00237185|O1|Outcome|Imatinib Mesylate 400 mg|"400 mg~Imatinib mesylate"
534063|NCT00237185|E2|Reported Event|Imatinib Mesylate 600 mg|600 mg
534064|NCT00237185|E1|Reported Event|Imatinib Mesylate 400 mg|400 mg
534065|NCT00237042|B4|Baseline|Total|Total of all reporting groups
534066|NCT00237042|B3|Baseline|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534067|NCT00237042|B2|Baseline|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534082|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534200|NCT00236080|B1|Baseline|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
534068|NCT00237042|B1|Baseline|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534069|NCT00237042|P3|Participant Flow|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534070|NCT00237042|P2|Participant Flow|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534071|NCT00237042|P1|Participant Flow|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534072|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534073|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534074|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534075|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534076|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534077|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534078|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534079|NCT00237042|O2|Outcome|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534080|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534081|NCT00237042|O3|Outcome|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534177|NCT00236197|B3|Baseline|Total|Total of all reporting groups
534178|NCT00236197|B2|Baseline|Rabeprazole 10 mg|
534179|NCT00236197|B1|Baseline|Placebo|
534083|NCT00237042|O1|Outcome|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534084|NCT00237042|E3|Reported Event|Continuous Oral Contraceptives|20 mcg ethinyl estradiol and 100 mcg levonorgestrel Combination pill (20 mcg ethinyl estradiol and 100 mcg levonorgestrel) taken daily for 6 months.
534085|NCT00237042|E2|Reported Event|Targeted Self Management|Self management as described for the first arm. However, the intervention also included education about the potential effects of hormones on TMD pain, instructions to monitor the association of pain and other symptoms with menstrual cycle changes, and planning for times in participants' menstrual cycles when symptoms might increase. Participant contacts were timed according to each participant's menstrual cycle.
534086|NCT00237042|E1|Reported Event|Self Management|Two 1.5-hour in-person sessions and 6 10-15-minute telephone calls delivered by a dental hygienist, trained and supervised by a clinical psychologist. Structured, manual-based treatment based on standard cognitive-behavioral pain therapies and self-management interventions for chronic TMD pain. Sessions included education about the biopsychosocial model of chronic pain, TMD etiology and treatments, and the rationale for self-management; relaxation and stress management training; discussion of the role of stress and emotions as potential factors exacerbating and maintaining TMD symptoms; instruction and practice in self-monitoring of symptoms to identify factors that might be helpful to modify through self-care methods; practice of dentist-prescribed self-care treatments; and discussion of strategies to maintain gains and prevent relapse.
534087|NCT00236977|B3|Baseline|Total|Total of all reporting groups
534088|NCT00236977|B2|Baseline|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534089|NCT00236977|B1|Baseline|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534090|NCT00236977|P2|Participant Flow|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534091|NCT00236977|P1|Participant Flow|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534092|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534093|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534094|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534095|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534096|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534097|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534098|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534099|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534100|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534101|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534102|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534103|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534104|NCT00236977|O2|Outcome|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534105|NCT00236977|O1|Outcome|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534106|NCT00236977|E2|Reported Event|Ferrous Sulfate|oral iron tablets; 325 mg three times a day orally for 56 days
534107|NCT00236977|E1|Reported Event|Venofer|iron sucrose injection; 500 mg intravenous (IV) infusion administered over 3.5-4 hours on Days 0 and 14, or 200 mg injections administered over 2-5 minutes on 5 different occasions from Day 0 to Day 14.
534108|NCT00236951|B5|Baseline|Total|Total of all reporting groups
534109|NCT00236951|B4|Baseline|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
534110|NCT00236951|B3|Baseline|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534111|NCT00236951|B2|Baseline|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
534180|NCT00236197|P2|Participant Flow|Rabeprazole 10 mg|
534112|NCT00236951|B1|Baseline|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534113|NCT00236951|P4|Participant Flow|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
534114|NCT00236951|P3|Participant Flow|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534115|NCT00236951|P2|Participant Flow|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
534116|NCT00236951|P1|Participant Flow|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534117|NCT00236951|O4|Outcome|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
534118|NCT00236951|O3|Outcome|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534119|NCT00236951|O2|Outcome|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
534120|NCT00236951|O1|Outcome|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534121|NCT00236951|E4|Reported Event|Group D: Erythropoietin Only (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin only.
534122|NCT00236951|E3|Reported Event|Group C: Erythropoietin + Venofer (Non-responders)|Subjects whose maximum hemoglobin increase was < 1 g/dL over baseline were designated as Stage 1 (8-week duration) non-responders. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534123|NCT00236951|E2|Reported Event|Group B: Erythropoietin Only (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin only.
534124|NCT00236951|E1|Reported Event|Group A: Erythropoietin + Venofer (Responders)|Subjects who at any time during Stage 1 (8-week duration) showed a > or = 1 g/dL increase in hemoglobin over baseline. These subjects received 100mcg of weekly Erythropoietin and up to three 500mg doses of Venofer at intervals of 2 to 3 weeks with last dose no later than Week 9 of Stage 2.
534125|NCT00236938|B3|Baseline|Total|Total of all reporting groups
534126|NCT00236938|B2|Baseline|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534127|NCT00236938|B1|Baseline|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534128|NCT00236938|P2|Participant Flow|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534129|NCT00236938|P1|Participant Flow|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534130|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534131|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534132|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534133|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534134|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534135|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534136|NCT00236938|O2|Outcome|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534137|NCT00236938|O1|Outcome|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534138|NCT00236938|E2|Reported Event|Group B: Erythropoietin EPO Fixed Dose Only|Stable erythropoietin (EPO) dose and no supplemental iron.
534181|NCT00236197|P1|Participant Flow|Placebo|
534182|NCT00236197|O2|Outcome|Rabeprazole 10 mg|
534183|NCT00236197|O1|Outcome|Placebo|
534184|NCT00236197|E2|Reported Event|Rabeprazole 10 mg|
534139|NCT00236938|E1|Reported Event|Group A: Venofer and Erythropoietin EPO Fixed Dose|Fixed dose of erythropoietin (EPO) and Venofer (300mg) administered intravenous infusion over 1.5 hours on Days 1 and 15, and Venofer (400mg) administered intravenous infusion over 2.5 hours on Day 29.
534140|NCT00236899|B5|Baseline|Total|Total of all reporting groups
534141|NCT00236899|B4|Baseline|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534142|NCT00236899|B3|Baseline|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534143|NCT00236899|B2|Baseline|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534144|NCT00236899|B1|Baseline|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534145|NCT00236899|P4|Participant Flow|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534146|NCT00236899|P3|Participant Flow|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534147|NCT00236899|P2|Participant Flow|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534148|NCT00236899|P1|Participant Flow|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534149|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534150|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534151|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534152|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534153|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534154|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534185|NCT00236197|E1|Reported Event|Placebo|
534186|NCT00236184|B3|Baseline|Total|Total of all reporting groups
534187|NCT00236184|B2|Baseline|Rabeprazole 10 mg|oral enteric-coated tablet
534188|NCT00236184|B1|Baseline|Placebo|oral placebo tablet
534155|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534156|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square meter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534157|NCT00236899|O4|Outcome|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534158|NCT00236899|O3|Outcome|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534159|NCT00236899|O2|Outcome|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534160|NCT00236899|O1|Outcome|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534161|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
534162|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534163|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
534164|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534165|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534189|NCT00236184|P2|Participant Flow|Rabeprazole 10 mg|
534190|NCT00236184|P1|Participant Flow|Placebo|
534191|NCT00236184|O2|Outcome|Rabeprazole 10 mg|
534192|NCT00236184|O1|Outcome|Placebo|
534193|NCT00236184|E2|Reported Event|Rabeprazole 10 mg|
534194|NCT00236184|E1|Reported Event|Placebo|
534195|NCT00236080|B6|Baseline|Total|Total of all reporting groups
534196|NCT00236080|B5|Baseline|Placebo|Matching placebo tablets once daily only on nights worked
534166|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534167|NCT00236899|O2|Outcome|Treatment Drug (Paclitaxel)|"Arm B, Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by followed by Gemcitabine on Day 1, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15 followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until disease progression."
534168|NCT00236899|O1|Outcome|Treatment Drug (Docetaxel)|"Arm A, Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m² 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm C, Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 min prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15, repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534169|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534170|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534171|NCT00236899|O2|Outcome|Treatment Schedule (3 Weekly)|"Arm A, Docetaxel and Gemcitabine (3 Weekly):~Docetaxel: 75 mg/m², 60 min IV infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm B, Paclitaxel and Gemcitabine (3 Weekly):~Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534172|NCT00236899|O1|Outcome|Treatment Schedule (Weekly)|"Arm C, Docetaxel and Gemcitabine (Weekly):~Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Arm D, Paclitaxel and Gemcitabine (Weekly):~Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534173|NCT00236899|E4|Reported Event|Arm D: Paclitaxel and Gemcitabine (Weekly)|"Paclitaxel: 80 mg/m², IV infusion over approximately 1 hour, Days 1, 8, and 15, followed by Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534174|NCT00236899|E3|Reported Event|Arm C: Docetaxel and Gemcitabine (Weekly)|"Docetaxel: 30 mg/m², 30-60 min IV infusion on Days 1, 8, and 15 to be given 30 minutes prior to Gemcitabine, repeated every 28 days (weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 800 mg/m², 30 min IV infusion on Days 1, 8, and 15 repeated every 28 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534175|NCT00236899|E2|Reported Event|Arm B: Paclitaxel and Gemcitabine (Tri-weekly)|"Paclitaxel: 175 mg/m², IV infusion over approximately 3 hours followed by Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD.~Gemcitabine: 1250 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534176|NCT00236899|E1|Reported Event|Arm A: Docetaxel and Gemcitabine (Tri-weekly)|"Docetaxel: 75 milligram per square millimeter (mg/m²), 60 minute (min) intravenous (IV) infusion on Day 1 only, to be given 30 min prior to Gemcitabine, repeated every 21 days (tri-weekly) for 10 cycles for complete responders (CRs=disappearance of all target lesions) or partial responders (PRs=≥30% decrease in sum of longest diameter of target lesions); 6 cycles for stable disease (SD=small changes that do not meet the above criteria); or until progressive disease (PD≥20% increase in sum of longest diameter of target lesions).~Gemcitabine: 1000 mg/m², 30 min IV infusion on Days 1 and 8, repeated every 21 days for 10 cycles for CRs or PRs; 6 cycles for SD; or until PD."
534201|NCT00236080|P5|Participant Flow|Placebo|Matching placebo tablets once daily only on nights worked
534202|NCT00236080|P4|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
534203|NCT00236080|P3|Participant Flow|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
534204|NCT00236080|P2|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
534205|NCT00236080|P1|Participant Flow|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
534206|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
534207|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
534208|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
534209|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
534210|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
534211|NCT00236080|O5|Outcome|Placebo|Matching placebo tablets once daily only on nights worked
534212|NCT00236080|O4|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
534213|NCT00236080|O3|Outcome|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
534214|NCT00236080|O2|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
534215|NCT00236080|O1|Outcome|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
534216|NCT00236080|E5|Reported Event|Placebo|Matching placebo tablets once daily only on nights worked
534217|NCT00236080|E4|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily only on nights worked
534218|NCT00236080|E3|Reported Event|Armodafinil 200 mg/Day|Armodafinil 200 mg once daily only on nights worked
534219|NCT00236080|E2|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily only on nights worked
534220|NCT00236080|E1|Reported Event|PROVIGIL 200 mg/Day|PROVIGIL 200 mg once daily only on nights worked
534221|NCT00235989|B5|Baseline|Total|Total of all reporting groups
534222|NCT00235989|B4|Baseline|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
534223|NCT00235989|B3|Baseline|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
534224|NCT00235989|B2|Baseline|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
534225|NCT00235989|B1|Baseline|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
534226|NCT00235989|P6|Participant Flow|CT: IFNB-1b 500mcg|Core Treatment 500 mcg
534227|NCT00235989|P5|Participant Flow|CT: IFNB-1b 250mcg|Core Treatment 250 mcg
534228|NCT00235989|P4|Participant Flow|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
534229|NCT00235989|P3|Participant Flow|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
534230|NCT00235989|P2|Participant Flow|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
534231|NCT00235989|P1|Participant Flow|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
534232|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
534233|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
534234|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
534235|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
534236|NCT00235989|O4|Outcome|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
534237|NCT00235989|O3|Outcome|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
534238|NCT00235989|O2|Outcome|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
534239|NCT00235989|O1|Outcome|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
534240|NCT00235989|E4|Reported Event|ET: IFNB-1b 250 mcg => 500 mcg|Extension Treatment 250 mcg increased to 500 mcg
534241|NCT00235989|E3|Reported Event|ET: IFNB-1b 500 mcg => 500 mcg|Extension Treatment 500 mcg continued
534242|NCT00235989|E2|Reported Event|ET: IFNB-1b 500 mcg => 250 mcg|Extension Treatment 500 mcg reduced to 250 mcg
534243|NCT00235989|E1|Reported Event|ET: IFNB-1b 250 mcg => 250 mcg|Extension Treatment 250 mcg continued
534244|NCT00235872|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534245|NCT00235872|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534246|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534247|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534248|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534249|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534250|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534251|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534252|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534253|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534254|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534255|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534256|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534257|NCT00235872|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534258|NCT00235872|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan
534259|NCT00235833|B1|Baseline|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534260|NCT00235833|P1|Participant Flow|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534261|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534262|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534263|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534264|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534265|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534266|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534267|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534268|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534269|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534270|NCT00235833|O1|Outcome|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534271|NCT00235833|E1|Reported Event|Adalimumab 40 mg Eow|Adalimumab 40 mg subcutaneously (sc) administered every other week (eow) until approval of adalimumab in Japan.
534272|NCT00235755|B4|Baseline|Total|Total of all reporting groups
534273|NCT00235755|B3|Baseline|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534274|NCT00235755|B2|Baseline|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534275|NCT00235755|B1|Baseline|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
534276|NCT00235755|P3|Participant Flow|Retigabine 300 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase.
534277|NCT00235755|P2|Participant Flow|Retigabine 200 mg TID|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks. Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase.
534278|NCT00235755|P1|Participant Flow|Placebo|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase. Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase.
534279|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534280|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534281|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534282|NCT00235755|O3|Outcome|Retigabine 300 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the 12-week Maintenance Phase
534283|NCT00235755|O2|Outcome|Retigabine 200 mg TID: Maintenance Phase|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the 12-week Maintenance Phase
534284|NCT00235755|O1|Outcome|Placebo: Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 12-week Maintenance Phase
534285|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
534286|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
534287|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
534288|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534289|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534290|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534291|NCT00235755|O6|Outcome|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
534292|NCT00235755|O5|Outcome|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
534293|NCT00235755|O4|Outcome|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
534294|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534295|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534296|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534297|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534298|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534299|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534300|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534301|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534302|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534303|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534372|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534304|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534305|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534306|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534307|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534308|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534309|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534310|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534311|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534312|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534313|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534314|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534315|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534316|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534317|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534318|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534319|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534320|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534321|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534322|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534323|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534324|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534325|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534326|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534327|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534328|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534329|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534330|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534331|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534332|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534333|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534334|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534335|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534336|NCT00235755|O3|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534337|NCT00235755|O2|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534338|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12-week Maintenance Phase
534339|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534340|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534341|NCT00235755|O1|Outcome|Placebo - DB Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 mg and 100 mg were administered orally TID during the 4-week Titration Phase and the 12 week Maintenance Phase
534373|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534593|NCT00235326|O1|Outcome|Unexposed to Gastroenteritis|
534342|NCT00235755|O3|Outcome|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534343|NCT00235755|O2|Outcome|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534344|NCT00235755|O1|Outcome|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
534345|NCT00235755|E6|Reported Event|Retigabine 300 mg TID - Transition Phase|Participants receiving retigabine 300 mg TID during the Maintenance Phase continued receiving retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Placebo doses were administered to maintain the blinding and were increased weekly by a maximum of 150 mg per day
534346|NCT00235755|E5|Reported Event|Retigabine 300 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 300 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 900 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 300 mg TID
534347|NCT00235755|E4|Reported Event|Retigabine 200 mg TID - Transition Phase|Participants receiving retigabine 200 mg TID during the Maintenance Phase were titrated to a target dose of 300 mg TID retigabine during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). Retigabine doses were increased weekly by a maximum of 150 mg per day
534348|NCT00235755|E3|Reported Event|Retigabine 200 mg TID - DB Phase (Titration Plus Maintenance)|Retigabine 50 mg and 100 mg tablets were administered orally for a target dose of 200 mg TID during the Titration Phase, during which participants were titrated from 300 mg per day to 600 mg per day with weekly increases in doses of 150 mg per day over the course of 2 to 4 weeks, followed by a 12-week Maintenance Phase, during which participants were administered 200 mg TID
534349|NCT00235755|E2|Reported Event|Placebo - Transition Phase|Participants receiving placebo during the Maintenance Phase were titrated to a target dose of retigabine 300 mg TID during the 4-week Transition Phase in a double-dummy, double-blind manner using a transition kit consisting of retigabine and placebo tablets (50 mg and 100 mg). The starting dose for retigabine titration was 100 mg TID and was increased weekly by a maximum of 150 mg per day
534350|NCT00235755|E1|Reported Event|Placebo - Double Blind (DB) Phase (Titration Plus Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg) and 100 mg were administered orally thrice a day (TID) during the 4-week Titration Phase and the 12-week Maintenance Phase
534351|NCT00235716|B5|Baseline|Total|Total of all reporting groups
534352|NCT00235716|B4|Baseline|Placebo|Matching placebo pills for vitamin E and memantine
534353|NCT00235716|B3|Baseline|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534354|NCT00235716|B2|Baseline|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534355|NCT00235716|B1|Baseline|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534356|NCT00235716|P4|Participant Flow|Placebo|Matching placebo pills for vitamin E and memantine
534357|NCT00235716|P3|Participant Flow|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534358|NCT00235716|P2|Participant Flow|Memantine (Namenda)|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534359|NCT00235716|P1|Participant Flow|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534360|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534361|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534362|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534363|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534364|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534365|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534366|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534367|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534368|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534369|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534370|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534371|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534374|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534375|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534376|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534377|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534378|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534379|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534380|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534381|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534382|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534383|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534384|NCT00235716|O4|Outcome|Placebo|Matching placebo pills for vitamin E and memantine
534385|NCT00235716|O3|Outcome|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534386|NCT00235716|O2|Outcome|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534387|NCT00235716|O1|Outcome|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534388|NCT00235716|E4|Reported Event|Placebo|Matching placebo pills for vitamin E and memantine
534389|NCT00235716|E3|Reported Event|Vitamin E + Memantine|2000 IU of Alpha-tocopherol (vitamin E) per day plus 20 mg memantine per day.
534390|NCT00235716|E2|Reported Event|Memantine|Memantine 20 mg per day, titrated over four weeks to a maintenance dosage of 10 mg pills taken twice a day plus matching vitamin E placebo.
534391|NCT00235716|E1|Reported Event|Vitamin E|Alpha-tocopherol (vitamin E in the form of dl-alpha-tocopheryl acetate), 2000 international units (IU) per day, taken as one 1000 IU hard-gelatin, liquid-filled capsules twice a day plus matching memantine placebos.
534392|NCT00235573|B1|Baseline|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
534393|NCT00235573|P1|Participant Flow|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
534394|NCT00235573|O1|Outcome|Vitamin B12 Group|All subjects received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
534395|NCT00235573|E1|Reported Event|All Study Participants|All study participants received the same treatment of 3 doses of 9 micrograms of vitamin B12 at 6 hour intervals on day 1.
534396|NCT00235456|B3|Baseline|Total|Total of all reporting groups
534397|NCT00235456|B2|Baseline|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534398|NCT00235456|B1|Baseline|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534399|NCT00235456|P2|Participant Flow|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534400|NCT00235456|P1|Participant Flow|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534401|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534402|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534403|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534404|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534405|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534406|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534407|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534408|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534409|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534410|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534411|NCT00235456|O2|Outcome|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534412|NCT00235456|O1|Outcome|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534413|NCT00235456|E2|Reported Event|30% Perioperative Oxygen|"Standard oxygen: Patients were randomly assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Standard oxygen: Patients were assigned to 30% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534414|NCT00235456|E1|Reported Event|80% Perioperative Oxygen|"Perioperative supplemental oxygen: Patients were randomly assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized.~Perioperative supplemental oxygen: Patients were assigned to 80% fraction of inspired oxygen (FIO2) intraoperatively and for 6 hours after surgery. Anesthetic treatment and antibiotic administration were standardized."
534415|NCT00235443|B7|Baseline|Total|Total of all reporting groups
534416|NCT00235443|B6|Baseline|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534417|NCT00235443|B5|Baseline|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534418|NCT00235443|B4|Baseline|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534419|NCT00235443|B3|Baseline|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534420|NCT00235443|B2|Baseline|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534421|NCT00235443|B1|Baseline|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534422|NCT00235443|P6|Participant Flow|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534423|NCT00235443|P5|Participant Flow|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534424|NCT00235443|P4|Participant Flow|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534425|NCT00235443|P3|Participant Flow|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534426|NCT00235443|P2|Participant Flow|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534470|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534427|NCT00235443|P1|Participant Flow|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534428|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534429|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534430|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534431|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534432|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534433|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534434|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534435|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534436|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534437|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534438|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534439|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534440|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534441|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534442|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534443|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534444|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534445|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534446|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534447|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534448|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534449|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534450|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534451|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534452|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534453|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534454|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534455|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534456|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534457|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534458|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534459|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534460|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534461|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534462|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534463|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534464|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534465|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534466|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534467|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534468|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534469|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534471|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534472|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534473|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534474|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534475|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534476|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534477|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534478|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534479|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534480|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534481|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534482|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534483|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534484|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534485|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534486|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534487|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534488|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534489|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534490|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534491|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534492|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534493|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534494|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534495|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534496|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534497|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534498|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534499|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534500|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534501|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534502|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534503|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534504|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534505|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534506|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534507|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534508|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534509|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534510|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534511|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534512|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534513|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534514|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534515|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534516|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534517|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534518|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534519|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534520|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534521|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534522|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534523|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534524|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534525|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534526|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534527|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534528|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534529|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534530|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534531|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534532|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534533|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534534|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534535|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534536|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534537|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534538|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534539|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534540|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534541|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534542|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534543|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534544|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534545|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534546|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534547|NCT00235443|O7|Outcome|Total|All modal dose groups combined
534548|NCT00235443|O6|Outcome|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534549|NCT00235443|O5|Outcome|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534550|NCT00235443|O4|Outcome|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534551|NCT00235443|O3|Outcome|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534552|NCT00235443|O2|Outcome|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534553|NCT00235443|O1|Outcome|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534554|NCT00235443|E7|Reported Event|Total|All modal dose groups combined
534555|NCT00235443|E6|Reported Event|Lacosamide 600mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534556|NCT00235443|E5|Reported Event|Lacosamide 500mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534557|NCT00235443|E4|Reported Event|Lacosamide 400mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534558|NCT00235443|E3|Reported Event|Lacosamide 300mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534559|NCT00235443|E2|Reported Event|Lacosamide 200mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534560|NCT00235443|E1|Reported Event|Lacosamide 100mg/Day|Modal dose = Open label doses (two times per day) include 100mg/day, 200mg/day, 300mg/day, 400mg/day, 500mg/day, 600mg/day
534561|NCT00235391|B7|Baseline|Total|Total of all reporting groups
534562|NCT00235391|B6|Baseline|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534563|NCT00235391|B5|Baseline|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534564|NCT00235391|B4|Baseline|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534565|NCT00235391|B3|Baseline|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534566|NCT00235391|B2|Baseline|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534567|NCT00235391|B1|Baseline|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534568|NCT00235391|P6|Participant Flow|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534569|NCT00235391|P5|Participant Flow|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534570|NCT00235391|P4|Participant Flow|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534571|NCT00235391|P3|Participant Flow|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534572|NCT00235391|P2|Participant Flow|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534573|NCT00235391|P1|Participant Flow|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534574|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534575|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534576|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534577|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534578|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534579|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534580|NCT00235391|O6|Outcome|≥ 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534581|NCT00235391|O5|Outcome|50 to < 65 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534582|NCT00235391|O4|Outcome|16 to < 50 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534583|NCT00235391|O3|Outcome|12 to < 16 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534584|NCT00235391|O2|Outcome|6 to < 12 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534585|NCT00235391|O1|Outcome|2 to < 6 Years|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534586|NCT00235391|E1|Reported Event|All Participants|Deferasirox was administered orally once a day, 30 minutes prior to breakfast. Dosage was based on participant's body weight. Tablets were dispersed in water, orange or apple juice.
534587|NCT00235326|B3|Baseline|Total|Total of all reporting groups
534588|NCT00235326|B2|Baseline|Exposed to Gastroenteritis|
534589|NCT00235326|B1|Baseline|Unexposed to Gastroenteritis|
534590|NCT00235326|P2|Participant Flow|Exposed to Gastroenteritis|
534591|NCT00235326|P1|Participant Flow|Unexposed to Gastroenteritis|
534592|NCT00235326|O2|Outcome|Exposed to Gastroenteritis|
534594|NCT00234884|B1|Baseline|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534595|NCT00234884|P1|Participant Flow|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534596|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534597|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534598|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534599|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534600|NCT00234884|O1|Outcome|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534601|NCT00234884|E1|Reported Event|Adalimumab|Participants were treated with commercially available adalimumab in normal clinical practice.
534602|NCT00234832|B3|Baseline|Total|Total of all reporting groups
534603|NCT00234832|B2|Baseline|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534604|NCT00234832|B1|Baseline|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534605|NCT00234832|P2|Participant Flow|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534606|NCT00234832|P1|Participant Flow|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534607|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534608|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534609|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534610|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534611|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534612|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534613|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534614|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534615|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534616|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534617|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534618|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534619|NCT00234832|O8|Outcome|CV + DM Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
534620|NCT00234832|O7|Outcome|CV + DM Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, and with a history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
534621|NCT00234832|O6|Outcome|CV Only Randomized to Placebo|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
534622|NCT00234832|O5|Outcome|CV Only Randomized to Sibutramine|Subjects with a history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease, but no history of type 2 DM with at least one other risk factor who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
534623|NCT00234832|O4|Outcome|DM Only Randomized to Placebo|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management.
534624|NCT00234832|O3|Outcome|DM Only Randomized to Sibutramine|Subjects with a history of type 2 DM with at least one other risk factor (i.e., hypertension controlled on medication, dyslipidemia, current cigarette smoking, diabetic nephropathy with evidence of microalbuminuria), but no history of coronary artery disease, cerebrovascular disease, or peripheral arterial occlusive disease who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management.
534625|NCT00234832|O2|Outcome|Randomized Placebo|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed placebo during the Treatment Period and continued standard care for weight management. If placebo was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534626|NCT00234832|O1|Outcome|Randomized Sibutramine|Subjects who completed the 6-week Lead-in Period and who were randomized and dispensed sibutramine during the Treatment Period and continued standard care for weight management. If sibutramine was prematurely discontinued, subjects continued standard care for weight management during the Follow-up Period.
534627|NCT00234832|E3|Reported Event|Randomized Placebo|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive placebo plus standard care for weight management during the Treatment Period of the Randomizaiton Phase, and if placebo was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
534628|NCT00234832|E2|Reported Event|Randomized Sibutramine|Subjects who successfully completed a 6-week Lead-in Period and who were randomized to receive sibutramine plus standard care for weight management during the Treatment Period of the Randomization Phase, and if sibutramine was prematurely discontinued, they received standard care for weight management during the Follow-up Period of the Randomization Phase.
534629|NCT00234832|E1|Reported Event|Lead-in Period Sibutramine|Subjects who received sibutramine 10 mg QD plus standard care for weight management during a 6-week Lead-in Period.
534630|NCT00234494|B1|Baseline|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534631|NCT00234494|P1|Participant Flow|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534632|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534633|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534634|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534635|NCT00234494|O1|Outcome|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534636|NCT00234494|E1|Reported Event|Single Group Assignment|"Cisplatin + Gemcitabine + Bevacizumab~Cisplatin: Cisplatin 70 mg/m2, day 1~Gemcitabine: Gemcitabine 1250 mg/m2, day 1 and 8~Bevacizumab: Bevacizumab 15mg/kg, day 1"
534637|NCT00233519|B3|Baseline|Total|Total of all reporting groups
534638|NCT00233519|B2|Baseline|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
534639|NCT00233519|B1|Baseline|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
534640|NCT00233519|P2|Participant Flow|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
534641|NCT00233519|P1|Participant Flow|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
534642|NCT00233519|O2|Outcome|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
534684|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with antipsychotic medication ordered pre-intervention
534643|NCT00233519|O1|Outcome|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
534644|NCT00233519|E2|Reported Event|Cohort 2-Three Escalating Doses of iPlex|N=9 Following approval of the safety monitoring committee who reviewed the data on the cohort 1, the second cohort received consecutive 8 week treatments of 0.5, 1.0, and 2.0 mg/kg/day of iPlex for a total of 24 weeks by self-administered subcuteanous injection.
534645|NCT00233519|E1|Reported Event|Cohort 1- Two Escalating Doses of iPlex|N=6 This group received self-administered subcuteanous injections of 0.5 mg/kg/day of iPlex for 8 weeks, followed by 1.0 mg/kg/day of iPlex for 16 weeks.
534646|NCT00233454|B1|Baseline|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
534647|NCT00233454|P1|Participant Flow|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
534648|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
534649|NCT00233454|O1|Outcome|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
534650|NCT00233454|E1|Reported Event|Midostaurin|"100 mg midostaurin twice daily as oral capsules~Midostaurin: Midostaurin is a broad-spectrum protein kinase inhibitor, acting on conventional PKC isoforms (α, β, γ); PDFRβ; VEGFR2; Syk; PKCη; Flk-1; Flt3; Cdk1/B; PKA; c-Kit; c-Fgr; c-Src; VEGFR1; and EGFR"
534651|NCT00233402|B3|Baseline|Total|Total of all reporting groups
534652|NCT00233402|B2|Baseline|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
534653|NCT00233402|B1|Baseline|Comparator|Standard White Light Cystoscopy
534654|NCT00233402|P2|Participant Flow|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
534655|NCT00233402|P1|Participant Flow|Comparator|Standard White Light Cystoscopy
534656|NCT00233402|O1|Outcome|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
534657|NCT00233402|O2|Outcome|White Light Group|
534658|NCT00233402|O1|Outcome|Hexvix Group|
534659|NCT00233402|O2|Outcome|White Light Group|
534660|NCT00233402|O1|Outcome|Hexvix Group|
534661|NCT00233402|O2|Outcome|White Light Group|
534662|NCT00233402|O1|Outcome|Hexvix Group|The primary endpoint was assessed from patients randomized to the Hexvix group only
534663|NCT00233402|E2|Reported Event|Hexvix Fluorescence Cystoscopy|Standard White Light and Hexvix Fluorescence Cystoscopy
534664|NCT00233402|E1|Reported Event|Comparator|Standard White Light Cystoscopy
534665|NCT00234286|B1|Baseline|Arm 1|"Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of on-site staff training together with an electronic order set for palliative care and educational materials"
534666|NCT00234286|P1|Participant Flow|BEACON Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
534667|NCT00234286|O2|Outcome|Post-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
534668|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with documented Palliative Care Consultation pre-intervention in their medical record
534669|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Advanced Directive post-intervention based on abstraction of medical record
534670|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Advanced Directive pre-intervention based on abstraction of medical record
534671|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Pastoral Care visit post-intervention based on abstraction of medical record
534672|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Pastoral Care Visit pre-intervention based on abstraction of medical record
534673|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Sublingual administration of medication during post-intervention based on abstraction of medical record
534674|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Sublingual administration of medication during pre-intervention based on abstraction of medical record
534675|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of scopolamine (for death rattle) during post -intervention based on abstraction of medical record
534676|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of scopolamine (for death rattle) during pre-intervention based on abstraction of medical record
534677|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of benzodiazepine medication during post-intervention based on abstraction of medical record
534678|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of benzodiazepine medication during pre-intervention based on abstraction of medical record
534679|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Order for benzodiazepine medication during post-intervention period based on abstraction of medical record
534680|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Order for benzodiazepine medication during pre-intervention period based on abstraction of medical record
534681|NCT00234286|O2|Outcome|Post-Intervention|Individuals with Administration of antipsychotic medication post-intervention
534682|NCT00234286|O1|Outcome|Pre-Intervention|Individuals with Administration of antipsychotic medication pre-intervention
534683|NCT00234286|O2|Outcome|Post-Intervention|Individuals with antipsychotic medication ordered post-intervention
534685|NCT00234286|O2|Outcome|Post-intervention|Individuals who received opioid medication post-intervention
534686|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who received opioid medication pre-intervention
534687|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with restraints during post-intervention
534688|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with restraints during pre-intervention
534689|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with an intravenous line post-intervention
534690|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with an intravenous line pre-intervention
534691|NCT00234286|O2|Outcome|Post-Intervention|Individuals who died with a nasogastric tube post-intervention
534692|NCT00234286|O1|Outcome|Pre-Intervention|Individuals who died with a nasogastric tube pre-intervention
534693|NCT00234286|O2|Outcome|Post-Intervention|Number of Patients who died in ICU Post-Intervention
534694|NCT00234286|O1|Outcome|Pre-Intervention|Number of Individuals who died in ICU Pre-Intervention
534695|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
534696|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
534697|NCT00234286|O2|Outcome|Post-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
534698|NCT00234286|O1|Outcome|Pre-Intervention|"Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials~Comfort care education intervention: Comfort care education intervention, consisting of intensive, on-site staff training together with an electronic order set for palliative care and educational materials"
534699|NCT00234286|E1|Reported Event|Arm 1|Arm 1: Comfort care education intervention, consisting of intensive, on-site staff training
534700|NCT00234104|B5|Baseline|Total|Total of all reporting groups
534701|NCT00234104|B4|Baseline|45 mg of OPC-41061|OPC-41061 45 mg/day
534702|NCT00234104|B3|Baseline|30 mg of OPC-41061|OPC-41061 30 mg/day
534703|NCT00234104|B2|Baseline|15 mg of OPC-41061|OPC-41061 15 mg/day
534704|NCT00234104|B1|Baseline|Placebo|OPC-41061 0 mg/day
534705|NCT00234104|P4|Participant Flow|45 mg of OPC-41061|OPC-41061 45 mg/day
534706|NCT00234104|P3|Participant Flow|30 mg of OPC-41061|OPC-41061 30 mg/day
534707|NCT00234104|P2|Participant Flow|15 mg of OPC-41061|OPC-41061 15 mg/day
534708|NCT00234104|P1|Participant Flow|Placebo|OPC-41061 0 mg/day
534709|NCT00234104|O4|Outcome|45 mg of OPC-41061|OPC-41061 45 mg/day
534710|NCT00234104|O3|Outcome|30 mg of OPC-41061|OPC-41061 30 mg/day
534711|NCT00234104|O2|Outcome|15 mg of OPC-41061|OPC-41061 15 mg/day
534712|NCT00234104|O1|Outcome|Placebo|OPC-41061 0 mg/day
534713|NCT00234104|E4|Reported Event|45 mg of OPC-41061|OPC-41061 45 mg/day
534714|NCT00234104|E3|Reported Event|30 mg of OPC-41061|OPC-41061 30 mg/day
534715|NCT00234104|E2|Reported Event|15 mg of OPC-41061|OPC-41061 15 mg/day
534716|NCT00234104|E1|Reported Event|Placebo|OPC-41061 0 mg/day
534717|NCT00234078|B5|Baseline|Total|Total of all reporting groups
534718|NCT00234078|B4|Baseline|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534719|NCT00234078|B3|Baseline|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534720|NCT00234078|B2|Baseline|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534721|NCT00234078|B1|Baseline|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534722|NCT00234078|P4|Participant Flow|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534723|NCT00234078|P3|Participant Flow|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534724|NCT00234078|P2|Participant Flow|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534725|NCT00234078|P1|Participant Flow|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534726|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534727|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534728|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534729|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534730|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534731|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534732|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534733|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534734|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534735|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534736|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534737|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534738|NCT00234078|O4|Outcome|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534739|NCT00234078|O3|Outcome|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534740|NCT00234078|O2|Outcome|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534741|NCT00234078|O1|Outcome|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534742|NCT00234078|E4|Reported Event|Placebo|0% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534743|NCT00234078|E3|Reported Event|2% OPC-12759|2% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534744|NCT00234078|E2|Reported Event|1% OPC-12759|1% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534745|NCT00234078|E1|Reported Event|0.5% OPC-12759|0.5% rebamipide ophthalmic suspension received one drop of to both eyes four times a day for 12 weeks
534746|NCT00234065|B3|Baseline|Total|Total of all reporting groups
534747|NCT00234065|B2|Baseline|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534748|NCT00234065|B1|Baseline|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534749|NCT00234065|P2|Participant Flow|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534750|NCT00234065|P1|Participant Flow|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534751|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534752|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534753|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534754|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534755|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534756|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534757|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534758|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534759|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534760|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534761|NCT00234065|O2|Outcome|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534762|NCT00234065|O1|Outcome|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534763|NCT00234065|E2|Reported Event|Aspirin|Aspirin, oral tablet, 81 mg aspirin
534764|NCT00234065|E1|Reported Event|Cilostazol|cilostazol, oral tablet, 100 mg cilostazol
534765|NCT00234039|B1|Baseline|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534766|NCT00234039|P1|Participant Flow|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534767|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534768|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534769|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534770|NCT00234039|O1|Outcome|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534771|NCT00234039|E1|Reported Event|Intravesical Gemcitabine|Patients receive induction treatment with instillations of 2 gm gemcitabine dissolved in 100 cc normal saline weekly for 6 weeks. Beginning at week 14, patients achieving a complete response (CR) after induction go onto maintenance and are treated with one intravesical gemcitabine every 4 weeks for 40 weeks.
534772|NCT00233987|B1|Baseline|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534773|NCT00233987|P1|Participant Flow|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either Total Body Irradiation(TBI)-based or 1,3-bis (2-chloroethyl)-1-nitrosourea(BCNU)-based high-dose therapy followed by infusion of at least 2 million cluster of differentiation 34 positive (CD34+) cells.
534774|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534775|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534776|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534777|NCT00233987|O1|Outcome|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534778|NCT00233987|E1|Reported Event|High-dose Therapy Plus Tandem Transplant|Regimen consists of 2 cycles of high-dose therapy, each followed by stem cell infusion. Cycle 1 consists of high-dose melphalan followed by infusion of approximately 1.5 million CD34+ cells. Cycle 2 consists of either TBI-based or BCNU-based high-dose therapy followed by infusion of at least 2 million CD34+ cells.
534779|NCT00233948|B3|Baseline|Total|Total of all reporting groups
534780|NCT00233948|B2|Baseline|Phase II|Oral Nelfinavir at 3000 mg bid
534781|NCT00233948|B1|Baseline|Phase I|Phase I dose escalation portion of the study. Initial dose of oral Nelfinavir was 1250 mg bid with escalation to the MTD at 4250 mg bid using a standard 3+3 dose escalation scheme.
534782|NCT00233948|P6|Participant Flow|Phase II|Oral Nelfinavir at 3000mg bid
534783|NCT00233948|P5|Participant Flow|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
534784|NCT00233948|P4|Participant Flow|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
534785|NCT00233948|P3|Participant Flow|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
534786|NCT00233948|P2|Participant Flow|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
534787|NCT00233948|P1|Participant Flow|Phase I: Dose Level 1|Oral Nelfinavir at 1250mg bid.
534788|NCT00233948|O1|Outcome|Phase II|Oral Nelfinavir at 3000 mg bid
534789|NCT00233948|O1|Outcome|Phase I|All patients enrolled on the Phase I (dose-finding) portion of the study.
534790|NCT00233948|O5|Outcome|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
534791|NCT00233948|O4|Outcome|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
534792|NCT00233948|O3|Outcome|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
534793|NCT00233948|O2|Outcome|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
534794|NCT00233948|O1|Outcome|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
534795|NCT00233948|E6|Reported Event|Phase II|Oral Nelfinavir at 3000 mg bid
534796|NCT00233948|E5|Reported Event|Phase I: Dose Level V|Oral Nelfinavir at 4250mg bid.
534797|NCT00233948|E4|Reported Event|Phase I: Dose Level IV|Oral Nelfinavir at 3000mg bid.
534798|NCT00233948|E3|Reported Event|Phase I: Dose Level III|Oral Nelfinavir at 2125mg bid.
534799|NCT00233948|E2|Reported Event|Phase I: Dose Level II|Oral Nelfinavir at 1500mg bid.
534800|NCT00233948|E1|Reported Event|Phase I: Dose Level I|Oral Nelfinavir at 1250mg bid.
534801|NCT00233324|B5|Baseline|Total|Total of all reporting groups
534802|NCT00233324|B4|Baseline|Early Surfactant and Higher Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)
534803|NCT00233324|B3|Baseline|Early Surfactant and Lower Range Oxygen|Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)
534804|NCT00233324|B2|Baseline|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)
534805|NCT00233324|B1|Baseline|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)
534806|NCT00233324|P4|Participant Flow|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
534807|NCT00233324|P3|Participant Flow|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
534808|NCT00233324|P2|Participant Flow|Early Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
534809|NCT00233324|P1|Participant Flow|Early Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
534810|NCT00233324|O4|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
534811|NCT00233324|O3|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
534812|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
534813|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
534814|NCT00233324|O2|Outcome|Higher Oxygen Saturation Target|SpO2 range (91% to 95%) until the infant is no longer requiring ventilatory support or oxygen.
534815|NCT00233324|O1|Outcome|Lower Oxygen Saturation Target|SpO2 range (85% to 89%) until the infant is no longer requiring ventilatory support or oxygen.
534816|NCT00233324|O2|Outcome|Surfactant|Intubation and administration of surfactant by 1 hour of age
534817|NCT00233324|O1|Outcome|CPAP|Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU
534818|NCT00233324|E4|Reported Event|CPAP and Higher Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 91-95% target oxygen saturation
534819|NCT00233324|E3|Reported Event|CPAP and Lower Range Oxygen|Continuous Positive Airway Pressure (CPAP) and 85-89% target oxygen saturation
534820|NCT00233324|E2|Reported Event|Surfactant and Higher Range Oxygen|Early Surfactant and 91-95% target oxygen saturation
535341|NCT00230009|B1|Baseline|Assessment Only|
534821|NCT00233324|E1|Reported Event|Surfactant and Lower Range Oxygen|Early Surfactant and 85-89% target oxygen saturation
534822|NCT00233103|B3|Baseline|Total|Total of all reporting groups
534823|NCT00233103|B2|Baseline|Placebo|Placebo for 10 weeks
534824|NCT00233103|B1|Baseline|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534825|NCT00233103|P2|Participant Flow|Placebo|Placebo for 10 weeks
534826|NCT00233103|P1|Participant Flow|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg) for 10 weeks
534827|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
534828|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534829|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
534830|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534831|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
534832|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534833|NCT00233103|O2|Outcome|Placebo|Placebo for 10 weeks
534834|NCT00233103|O1|Outcome|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534835|NCT00233103|E2|Reported Event|Placebo|Placebo for 10 weeks
534836|NCT00233103|E1|Reported Event|Sertraline|Daily oral sertraline in doses starting at 25mg and increasing to therapeutic levels (up to 200mg)
534837|NCT00233090|B3|Baseline|Total|Total of all reporting groups
534838|NCT00233090|B2|Baseline|Placebo|daily dose of placebo for four weeks
534839|NCT00233090|B1|Baseline|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534840|NCT00233090|P2|Participant Flow|Placebo|daily dose of placebo for four weeks
534841|NCT00233090|P1|Participant Flow|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534842|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534843|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534844|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534845|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534846|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534847|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534848|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534849|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534850|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534851|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534852|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534853|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534854|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534855|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534856|NCT00233090|O2|Outcome|Placebo|daily dose of placebo for four weeks
534857|NCT00233090|O1|Outcome|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534858|NCT00233090|E2|Reported Event|Placebo|daily dose of placebo for four weeks
534859|NCT00233090|E1|Reported Event|Modafinil|single dose of 200 mg. a day of modafinil for four weeks
534860|NCT00233064|B3|Baseline|Total|Total of all reporting groups
534861|NCT00233064|B2|Baseline|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
534862|NCT00233064|B1|Baseline|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
534863|NCT00233064|P2|Participant Flow|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
534864|NCT00233064|P1|Participant Flow|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
534865|NCT00233064|O3|Outcome|Combined Liquid/Lyophilized Palivizumab|
534866|NCT00233064|O2|Outcome|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
534867|NCT00233064|O1|Outcome|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
534868|NCT00233064|E2|Reported Event|Lyophilized Palivizumab|Lyophilized Palivizumab, 15 mg/kg IM q30 days X 5
534869|NCT00233064|E1|Reported Event|Liquid Palivizumab|Liquid Palivizumab, 15 mg/kg IM q30 days X 5
534870|NCT00232739|B1|Baseline|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534871|NCT00232739|P1|Participant Flow|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534872|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534873|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534874|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534875|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534876|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534877|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534878|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534879|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534880|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534881|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534882|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534883|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534884|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534885|NCT00232739|O1|Outcome|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534886|NCT00232739|E1|Reported Event|2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-exp Stent|The 2.25mm Sirolimus-eluting Bx VELOCITY™ Balloon-expandable stent in patients with de novo native coronary artery lesions
534887|NCT00232596|B3|Baseline|Total|Total of all reporting groups
534888|NCT00232596|B2|Baseline|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534889|NCT00232596|B1|Baseline|Placebo - Double-blind (DB) Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534890|NCT00232596|P2|Participant Flow|Retigabine|Titration Phase: retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID with a starting daily dose of 300 mg/day (in 3 equally divided doses). The dose increased weekly by 150 mg/day (50 mg TID) for the 6 weeks of the Titration Phase to a target daily dose of 1200 mg/day (400 mg TID) by the beginning of Week 7 of treatment. Maintenance Phase: Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks in participants who tolerated this dose. Participants who could not tolerate the 1200 mg/day dose were allowed to reduce the dose to 1050 mg/day (350 mg TID) at the end of the first week and then maintain this dose for the remainder of the 12 weeks.
534891|NCT00232596|P1|Participant Flow|Placebo|Titration Phase: matching placebo tablets of dummy strengths of 50 milligrams (mg), 100 mg, and 300 mg administered orally thrice a day (TID) for 6 weeks. Maintenance Phase: matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks.
534892|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534893|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534894|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534895|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534896|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534897|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534898|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534899|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534900|NCT00232596|O4|Outcome|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534901|NCT00232596|O3|Outcome|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534964|NCT00232544|P1|Participant Flow|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
534902|NCT00232596|O2|Outcome|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534903|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534904|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534905|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534906|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534907|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534908|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534909|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534910|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534911|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534912|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534913|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534914|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534915|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534916|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534917|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534918|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534919|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534920|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534921|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534922|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534923|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534924|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534925|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534965|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
534966|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
534967|NCT00232544|O2|Outcome|TLC-Control|A TLC system for providing general health education
534926|NCT00232596|O2|Outcome|Retigabine DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534927|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534928|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID), for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534929|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534930|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534931|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534932|NCT00232596|O2|Outcome|Retigabine - Maintenance Phase|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534933|NCT00232596|O1|Outcome|Placebo - Maintenance Phase|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 12 weeks
534934|NCT00232596|O2|Outcome|Retigabine - DB Phase (Titration + Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534935|NCT00232596|O1|Outcome|Placebo - DB Phase (Titration + Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534936|NCT00232596|E4|Reported Event|Retigabine (DB Phase) and Retigabine (Transition Phase)|Participants on retigabine during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534937|NCT00232596|E3|Reported Event|Retigabine - DB Phase (Titration and Maintenance)|Retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a target daily dose of 1200 mg/day (400 mg TID) for 18 weeks (6 weeks of the Titration Phase, with dosage increase from 300 mg/day to 1200 mg/day [weekly increase of 150 mg/day], and 12 weeks of the Maintenance Phase, with 1200 mg/day or 1050 mg/day [for participants who could not tolerate 1200 mg/day])
534938|NCT00232596|E2|Reported Event|Placebo (DB Phase) and Retigabine (Transition Phase)|Participants on placebo during the DB phase were administered retigabine tablets of strengths 50 mg, 100 mg, and 300 mg administered orally TID for a total daily dose of 1200 mg/day (400 mg TID) for 6 weeks
534939|NCT00232596|E1|Reported Event|Placebo - Double-blind (DB) Phase (Titration and Maintenance)|Matching placebo tablets of dummy strengths of 50 mg, 100 mg, and 300 mg administered orally TID for 18 weeks (6 weeks of Titration Phase and 12 weeks of Maintenance Phase)
534940|NCT00232583|B3|Baseline|Total|Total of all reporting groups
534941|NCT00232583|B2|Baseline|Metfomin, Pioglitazone & Glyburide|
534942|NCT00232583|B1|Baseline|Metfomin & Insulin|
534943|NCT00232583|P2|Participant Flow|Metfomin, Pioglitazone & Glyburide|
534944|NCT00232583|P1|Participant Flow|Metfomin & Insulin|
534945|NCT00232583|O2|Outcome|Metformin, GLyburide & Pioglitazone|
534946|NCT00232583|O1|Outcome|Metformin & Insulin|
534947|NCT00232583|E2|Reported Event|Metfomin, Pioglitazone & Glyburide|
534948|NCT00232583|E1|Reported Event|Metfomin & Insulin|
534949|NCT00232557|B3|Baseline|Total|Total of all reporting groups
534950|NCT00232557|B2|Baseline|TLC-health Education|A TLC system for providing general health education
534951|NCT00232557|B1|Baseline|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
534952|NCT00232557|P2|Participant Flow|TLC-health Education|A TLC system for providing general health education
534953|NCT00232557|P1|Participant Flow|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
534954|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
534955|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
534956|NCT00232557|O2|Outcome|TLC-health Education|A TLC system for providing general health education
534957|NCT00232557|O1|Outcome|TLC-Asthma|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
534958|NCT00232557|E2|Reported Event|Arm 2|A TLC system for providing general health education
534959|NCT00232557|E1|Reported Event|Arm 1|A telephone-linked communication (TLC) system to improve asthma self-management by enhancing compliance with preventive medication regimens
534960|NCT00232544|B3|Baseline|Total|Total of all reporting groups
534961|NCT00232544|B2|Baseline|TLC-Control|A TLC system for providing general health education
534962|NCT00232544|B1|Baseline|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
534963|NCT00232544|P2|Participant Flow|TLC-Control|A TLC system for providing general health education
535745|NCT00226590|O1|Outcome|Induction Therapy|Tolerance of Induction Therapy prior to Chemoradiation
534968|NCT00232544|O1|Outcome|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
534969|NCT00232544|E2|Reported Event|TLC-Control|A TLC system for providing general health education
534970|NCT00232544|E1|Reported Event|TLC-CPAP|A telephone-linked communication (TLC) system for promoting adherence to continuous positive airway pressure (CPAP)
534971|NCT00232479|B1|Baseline|Group 1|treat with taxotere, herceptin, carboplatin in dose dense fashion
534972|NCT00232479|P1|Participant Flow|Group 1|study group receives taxotere, herceptin and carboplatin in dose dense fashion
534973|NCT00232479|O1|Outcome|Group 1|patients received herceptin, carboplatin and taxotere in a dose dense fashion.
534974|NCT00232479|O1|Outcome|Group 1|patients received dose dense herceptin, carboplatin and taxotere
534975|NCT00232479|E1|Reported Event|Group 1|patients received herceptin, carboplatin, taxotere in dose dense fashion
534976|NCT00232180|B3|Baseline|Total|Total of all reporting groups
534977|NCT00232180|B2|Baseline|Placebo|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534978|NCT00232180|B1|Baseline|Eplerenone|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534979|NCT00232180|P3|Participant Flow|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
534980|NCT00232180|P2|Participant Flow|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534981|NCT00232180|P1|Participant Flow|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534982|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534983|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534984|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534985|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534986|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534987|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534988|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534989|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534990|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534991|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534992|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534993|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534994|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535216|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
534995|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534996|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534997|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
534998|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
534999|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535000|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535001|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535002|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535003|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535004|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535005|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535006|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535007|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535008|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535009|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535010|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535011|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535012|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535013|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535014|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535015|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535217|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535016|NCT00232180|O2|Outcome|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535017|NCT00232180|O1|Outcome|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535018|NCT00232180|E5|Reported Event|Eplerenone: Open Label Phase|Participants from double blind phase received eplerenone 25 mg tablet orally once daily on top of standard heart failure therapy for 12 months. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an eGFR between 30 to 49 ml/min/1.73m^2 in the double blind phase, initial dose was 25 mg orally once every other day; at Week 4, dose might had been increased to a maximum of 25 mg once daily based on serum potassium level.
535019|NCT00232180|E4|Reported Event|Placebo: Double-blind Phase|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535020|NCT00232180|E3|Reported Event|Eplerenone: Double-blind Phase|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heartfailure therapy. Dose might have been increased at Week 4 to 50 mg once daily.For participants with an estimated glomerular filtration rate (eGFR) between 30 to49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initialdose was 25 mg orally once every other day; at Week 4, dose might have beenincreased to a maximum of 25 mg once daily based on serum potassium level.
535021|NCT00232180|E2|Reported Event|Placebo: Double-blind Phase(May 25, 2010 Data Cutoff)|Placebo matching to eplerenone 25 mg orally once daily on top of standard heart failure therapy.
535022|NCT00232180|E1|Reported Event|Eplerenone: Double-blind Phase (May 25, 2010 Data Cut-off)|Eplerenone 25 milligram (mg) tablet orally once daily on top of standard heart failure therapy. Dose might have been increased at Week 4 to 50 mg once daily. For participants with an estimated glomerular filtration rate (eGFR) between 30 to 49 milliliter per minute divided by 1.73 squared meter (ml/min/1.73m^2), initial dose was 25 mg orally once every other day; at Week 4, dose might have been increased to a maximum of 25 mg once daily based on serum potassium level.
535023|NCT00232141|B3|Baseline|Total|Total of all reporting groups
535024|NCT00232141|B2|Baseline|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535025|NCT00232141|B1|Baseline|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535026|NCT00232141|P2|Participant Flow|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535027|NCT00232141|P1|Participant Flow|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535028|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535029|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535030|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535031|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535032|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535033|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535034|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535035|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535036|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535037|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535218|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535038|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535039|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535040|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535041|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535042|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535043|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535044|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535045|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535046|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535047|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535048|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535049|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535050|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535051|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535052|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535053|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535054|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535055|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535056|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535057|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535058|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535059|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535060|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535953|NCT00224120|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
535061|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535062|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535063|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535064|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535065|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535066|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535067|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535068|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535069|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535070|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535071|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535072|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535073|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535074|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535075|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535076|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535077|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535078|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535079|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535080|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535081|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535082|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535170|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535083|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535084|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535085|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535086|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535087|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535088|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535089|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535090|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535091|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535092|NCT00232141|O2|Outcome|Placebo|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up Phase. Subjects were randomized in a 1:1 ratio.
535093|NCT00232141|O1|Outcome|Pregabalin|Study included a Screening phase, a 2-week double-blind Dose Adjustment phase, a 12-week double-blind Maintenance phase, and ended with a 1-week Taper/Follow-up phase. Subjects were randomized in a 1:1 ratio and were allowed to achieve a maximum dose of 600 mg/day (300 mg BID) and a minimum dose of 150 mg/day (75 mg BID) during the Maintenance phase.
535094|NCT00231816|B3|Baseline|Total|Total of all reporting groups
535095|NCT00231816|B2|Baseline|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535096|NCT00231816|B1|Baseline|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535097|NCT00231816|P2|Participant Flow|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535098|NCT00231816|P1|Participant Flow|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535099|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535100|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535101|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535102|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535103|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535104|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535105|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL SC injection administered comcomitantly with 0.5 mL IM influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535106|NCT00231816|O2|Outcome|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535107|NCT00231816|O1|Outcome|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535108|NCT00231816|E2|Reported Event|Nonconcomitant Group|Influenza vaccine 0.5 mL IM injection administerd with placebo injection on Day 1 and ZOSTAVAX™ 0.65 mL SC injection at Week 4
535109|NCT00231816|E1|Reported Event|Concomitant Group|ZOSTAVAX™ 0.65 mL subcutaneous (SC) injection administered concomitantly with 0.5 mL intramuscular (IM) influenza vaccine injection at separate injection sites on Day 1 and placebo injection at Week 4
535110|NCT00231777|B3|Baseline|Total|Total of all reporting groups
535219|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
536666|NCT00217022|B1|Baseline|Budesonide|9 mg daily
535111|NCT00231777|B2|Baseline|Ondansetron IV 4 mg|"On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.~The formulation of MK0517 used in this study was a non polysorbate (PS80) formulation which was not further developed and is not available for use.~Data Reported is for all all participants who received active study therapy."
535112|NCT00231777|B1|Baseline|MK0517 Intravenous (IV) 40 mg|"On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.~Data Reported is for all all participants who received active study therapy."
535113|NCT00231777|P2|Participant Flow|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535114|NCT00231777|P1|Participant Flow|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535115|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535116|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535117|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535118|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535119|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535120|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535121|NCT00231777|O2|Outcome|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535122|NCT00231777|O1|Outcome|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535123|NCT00231777|E2|Reported Event|Ondansetron IV 4 mg|On Day 1- All patients assigned to the ondansetron treatment group were administered 1 vial of ondansetron 4 mg and 1 vial of matching sterile normal saline 0.9% placebo for MK0517.
535124|NCT00231777|E1|Reported Event|MK0517 Intravenous (IV) 40 mg|On Day 1-All patients assigned to the MK0517 treatment group were administered 1 vial of MK0517 40 mg and 1 vial of matching sterile normal saline 0.9% placebo for ondansetron.
535125|NCT00231478|B3|Baseline|Total|Total of all reporting groups
535126|NCT00231478|B2|Baseline|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535127|NCT00231478|B1|Baseline|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535128|NCT00231478|P2|Participant Flow|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535129|NCT00231478|P1|Participant Flow|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535130|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535131|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535132|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535133|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535134|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535135|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535136|NCT00231478|O2|Outcome|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535137|NCT00231478|O1|Outcome|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535138|NCT00231478|E2|Reported Event|Granisetron 40 ug/kg|Drug: granisetron [Kytril] , 40 micrograms intravenously (iv) 15 min prior to end of surgery
535139|NCT00231478|E1|Reported Event|Granisetron 20 ug/kg|Drug: granisetron [Kytril], 20 micrograms intravenously (iv) 15 min prior to end of surgery
535140|NCT00231465|B1|Baseline|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
535141|NCT00231465|P1|Participant Flow|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|Eligible patients were treated with docetaxel 75 mg/m2 every three weeks and gefitinib 250 mg orally daily. Docetaxel and ZD1839 (gefitinib) were given for two cycles beyond maximal response. Gefitinib was continued until disease progression. Co-morbidities and activities of daily living were assessed (IADL).
535171|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535220|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
536667|NCT00217022|P2|Participant Flow|Placebo|three tablets daily
535142|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
535143|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
535144|NCT00231465|O1|Outcome|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
535145|NCT00231465|E1|Reported Event|Taxotere® (Docetaxel) + ZD1839 (IRESSA®)|"Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.~ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.~ZD1839 : ZD1839 will be continued until progression, or until trial closure, whichever comes first.~docetaxel (Taxotere®) : Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued."
535146|NCT00231309|B1|Baseline|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
535147|NCT00231309|P1|Participant Flow|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
535148|NCT00231309|O1|Outcome|Granulocyte Colony Stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
535149|NCT00231309|O1|Outcome|Granulocyte-stimulating Factor|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
535150|NCT00231309|E1|Reported Event|Single Arm|Granulocyte Colony Stimulating Factor : Granulocyte Colony Stimulating Factor
535151|NCT00231283|B1|Baseline|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535152|NCT00231283|P1|Participant Flow|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535153|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535154|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535155|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535156|NCT00231283|O1|Outcome|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535157|NCT00231283|E1|Reported Event|CYPHER NxT Stent on the BX SONIC OTW SDS|CYPHER NxT Sirolimus-eluting Coronary Stent on the BX SONIC Over-the-wire Stent Delivery System
535158|NCT00231179|B3|Baseline|Total|Total of all reporting groups
535159|NCT00231179|B2|Baseline|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535160|NCT00231179|B1|Baseline|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535161|NCT00231179|P2|Participant Flow|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535162|NCT00231179|P1|Participant Flow|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535163|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535164|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535165|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535166|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535167|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535168|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535169|NCT00231179|O2|Outcome|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535215|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
536668|NCT00217022|P1|Participant Flow|Budesonide|9 mg daily
535172|NCT00231179|O1|Outcome|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535173|NCT00231179|E2|Reported Event|Control|The control group received an information booklet on child/family services upon enrollment and transportation for the follow-up evaluations. They were called every 4 months to maintain contact information.
535174|NCT00231179|E1|Reported Event|Home Visiting Intervention|The intervention group received home visits and follow up calls keyed to well child visits following American Academy of Pediatric guidelines. Follow-up and reminder calls were made to track health care visits completed and referrals made.
535175|NCT00231153|B3|Baseline|Total|Total of all reporting groups
535176|NCT00231153|B2|Baseline|Povidone-Iodine|
535177|NCT00231153|B1|Baseline|Omiganan 1% Gel|
535178|NCT00231153|P2|Participant Flow|Povidone-Iodine|"All treated patients: Properly consented patients who received 1 or more doses of Povidone-Iodine with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
535179|NCT00231153|P1|Participant Flow|Omiganan 1% Gel|"All treated patients: Properly consented patients who received 1 or more doses of omiganan 1% gel with any post baseline observations (Primary Safety Population).~Modified Intent to Treat Subset: all ITT patients who did not have a BSI at randomization (baseline BSI) as determined by EC adjudication. Patients classified as 'present' (i.e. failure) or 'indeterminate' for baseline BSI were excluded from the MITT population. Patients missing baseline BSI status from EC adjudication were excluded from the MITT population. MITT Among Survivors: patients from the MITT population who did not die on study or who died and were positive (indeterminate or failure)for the study endpoint being analyzed prior to death (as determined by EC adjudication)."
535180|NCT00231153|O2|Outcome|Povidone-Iodine|
535181|NCT00231153|O1|Outcome|Omiganan 1% Gel|
535182|NCT00231153|O2|Outcome|Povidone-Iodine|
535183|NCT00231153|O1|Outcome|Omiganan 1% Gel|
535184|NCT00231153|O2|Outcome|Povidone-Iodine|
535185|NCT00231153|O1|Outcome|Omiganan 1% Gel|
535186|NCT00231114|B3|Baseline|Total|Total of all reporting groups
535187|NCT00231114|B2|Baseline|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535188|NCT00231114|B1|Baseline|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535189|NCT00231114|P2|Participant Flow|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535190|NCT00231114|P1|Participant Flow|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535191|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535192|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535193|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535194|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535195|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535196|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535197|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535198|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535199|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535200|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535201|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535202|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535203|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535204|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535205|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535206|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535207|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535208|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535209|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535210|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535211|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535212|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535213|NCT00231114|O2|Outcome|Sham|Sham bronchoscopy plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535214|NCT00231114|O1|Outcome|Alair|Alair treatment plus conventional therapy with inhaled corticosteroids and long acting β2-agonists.
535954|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
535221|NCT00231114|E4|Reported Event|Sham (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Sham treatment.
535222|NCT00231114|E3|Reported Event|Alair (Post-Treatment Period)|Six weeks after the last bronchoscopy session until 12 Months. Airways treated with the Alair System.
535223|NCT00231114|E2|Reported Event|Sham (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Sham treatment.
535224|NCT00231114|E1|Reported Event|Alair (Treatment Period)|Day of first bronchoscopy session until 6 weeks after the last bronchoscopy session. Airways treated with the Alair System.
535225|NCT00231062|B1|Baseline|Balloon Dilation of Sinus Ostia|
535226|NCT00231062|P1|Participant Flow|Balloon Dilation of Sinus Ostia|
535227|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
535228|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
535229|NCT00231062|O1|Outcome|Balloon Dilation of Sinus Ostia|
535230|NCT00231062|E1|Reported Event|Balloon Dilation of Sinus Ostia|
535231|NCT00230971|B3|Baseline|Total|Total of all reporting groups
535232|NCT00230971|B2|Baseline|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535233|NCT00230971|B1|Baseline|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535234|NCT00230971|P2|Participant Flow|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535235|NCT00230971|P1|Participant Flow|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535236|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535237|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535238|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535239|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535240|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535241|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535242|NCT00230971|O2|Outcome|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535243|NCT00230971|O1|Outcome|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535244|NCT00230971|E2|Reported Event|Ceftriaxone|Ceftriaxone sodium 2 g administered IV once daily plus metronidazole 1 to 2 g daily in divided IV doses.
535245|NCT00230971|E1|Reported Event|Tigecycline|Tigecycline administered IV every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
535246|NCT00230802|B3|Baseline|Total|Total of all reporting groups
535247|NCT00230802|B2|Baseline|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
535248|NCT00230802|B1|Baseline|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
535249|NCT00230802|P2|Participant Flow|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
535250|NCT00230802|P1|Participant Flow|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
535251|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
535252|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
535253|NCT00230802|O2|Outcome|3 Tablet Increase|"Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine by 3 extra tablets of their current dose per week."
535254|NCT00230802|O1|Outcome|2 Tablet Increase|"Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)~Anticipatory dose increase of levothyroxine: as it is know that levothyroxine requirement increases in pregnancy, both study arms will increase levothyroxine dose, though by different amounts.~levothyroxine: patients will increase levothyroxine dosage by 2 extra tablets of their current dose per week"
535255|NCT00230802|O2|Outcome|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
535256|NCT00230802|O1|Outcome|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
535257|NCT00230802|E2|Reported Event|3 Tablet Increase|Patients will increase their levothyroxine dosage by 3 extra tablets per week (~43%).
535258|NCT00230802|E1|Reported Event|2 Tablet Increase|Patients will increase their current levothyroxine dose by 2 extra tablets per week (~29% increase)
535259|NCT00230282|B1|Baseline|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
535334|NCT00230022|P1|Participant Flow|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
535260|NCT00230282|P1|Participant Flow|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
535261|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
535262|NCT00230282|O1|Outcome|Fludarabine and Cyclophosphamide, Followed by Alemtuzumab|Fludarabine 25 mg/m2/d IV and cyclophosphamide 250 mg/m2/d SC on days 1 to 3 for each of six 28-day cycles, when the assessment for Primary Completion occurred. Responders entered a no-treatment rest period (observation) for 3 to 8 weeks, then depending on status, continued on follow-up or on-study to receive alemtuzumab IV starting at 3 mg/day with the dose adjusted to the maximum tolerated dose (up to 30 mg).
535263|NCT00230282|E1|Reported Event|Fludarabine, Cytoxan, Then Alemtuzumab|"Fludarabine and cyclophosphamide days 1 to 3 for six 28-day cycles. Minimal residual disease positive responders continued on-treatment to receive alemtuzumab 30 mg weekly. MRD negative responders were observed.~Alemtuzumab: 3 to 30 mg, IV~Fludarabine: [(2R,3R,4S,5R)-5-(6-amino-2-fluoro-purin-9-yl)- 3,4-dihydroxy-oxolan-2-yl]methoxyphosphonic acid~Cytoxan: (RS)-N,N-bis(2-chloroethyl)-1,3,2-oxazaphosphinan-2-amine 2-oxide"
535264|NCT00230178|B4|Baseline|Total|Total of all reporting groups
535265|NCT00230178|B3|Baseline|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535266|NCT00230178|B2|Baseline|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535267|NCT00230178|B1|Baseline|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535268|NCT00230178|P3|Participant Flow|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535269|NCT00230178|P2|Participant Flow|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535270|NCT00230178|P1|Participant Flow|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535271|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535272|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535273|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535274|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535275|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535276|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535277|NCT00230178|O3|Outcome|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535278|NCT00230178|O2|Outcome|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535279|NCT00230178|O1|Outcome|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535280|NCT00230178|E3|Reported Event|Allopurinol|Allopurinol (300 mg/day) given alone as a single agent for 5 days
535281|NCT00230178|E2|Reported Event|Rasburicase + Allopurinol|Rasburicase (0.20 mg/kg/day) given alone as a single agent from Day 1 through Day 3, followed by oral allopurinol (300 mg/day) given from Day 3 through Day 5 (Day 3 is an overlap)
535282|NCT00230178|E1|Reported Event|Rasburicase|Rasburicase (0.20 mg/kg/day) given as a single agent for 5 days
535283|NCT00230126|B3|Baseline|Total|Total of all reporting groups
535284|NCT00230126|B2|Baseline|Arm B: Cycle 1 - 150-200 mg/Day Depending on Body Weight|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535285|NCT00230126|B1|Baseline|Arm A: 150 mg/Day|"150 mg/day~erlotinib: Arm A: 150 mg/day Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535286|NCT00230126|P2|Participant Flow|Arm B: Erlotinib 150 to 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535287|NCT00230126|P1|Participant Flow|Arm A: Erlotinib 150 mg/Day|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535288|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535289|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535290|NCT00230126|O2|Outcome|B Erlotinib Cycle 1 Dose Modified According to Weight|"erlotinib Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535291|NCT00230126|O1|Outcome|A Erlotinib 150 mg/Day Cycles 1 - 3|"erlotinib 150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535292|NCT00230126|O2|Outcome|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535293|NCT00230126|O1|Outcome|Erlotinib: Arm A: 150 mg/Day Cycles 1 - 3.|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535294|NCT00230126|E2|Reported Event|Arm B: Cycle 1 - 175 or 200 mg/Day Depending on Body Weight; C|"Cycle 1 dose modified according to patient's weight; Cycles 2 and up, dose titrated to generate skin rash.~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535295|NCT00230126|E1|Reported Event|Arm A: 150 mg/Day Cycles 1 - 3|"150 mg/day cycles 1 - 3~erlotinib: Arm A: 150 mg/day cycles 1 - 3. Arm B: Cycle 1 - 175 or 200 mg/day depending on body weight; Cycle 2 - if rash developed, then 150 mg/day; if no rash, then 175 mg/day; Cycle 3 - if rash developed, then 175 mg/day; if no rash, then 200 mg/day."
535296|NCT00230100|B3|Baseline|Total|Total of all reporting groups
535297|NCT00230100|B2|Baseline|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535298|NCT00230100|B1|Baseline|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535299|NCT00230100|P2|Participant Flow|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535300|NCT00230100|P1|Participant Flow|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535301|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535302|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535335|NCT00230022|O2|Outcome|Assessment Only|Only assessment measures with no subsequent intervention.
535338|NCT00230022|E1|Reported Event|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
535303|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535304|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535305|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535306|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535307|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535308|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535309|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535310|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535311|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535336|NCT00230022|O1|Outcome|Brief Computer-delivered Motivational Intervention|A brief assessment, plus a brief (20-minute) motivational intervention delivered solely by computer. The software was synchronously interactive and followed a traditional motivational interviewing approach.
535337|NCT00230022|E2|Reported Event|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
535339|NCT00230009|B3|Baseline|Total|Total of all reporting groups
535340|NCT00230009|B2|Baseline|Brief Intervention Session|
535312|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535313|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535314|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535315|NCT00230100|O2|Outcome|Mixed-gender Group Drug Counseling|Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance use disorders; 3) increase patients’ self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
535316|NCT00230100|O1|Outcome|Women's Recovery Group|The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.
535317|NCT00230100|E2|Reported Event|Mixed-gender Group Drug Counseling|The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances of abuse; 2) educate patients regarding recovery from substance dependence; 3) increase patients’ self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
535318|NCT00230100|E1|Reported Event|Women's Recovery Group|The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance abuse antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.
535319|NCT00230048|B3|Baseline|Total|Total of all reporting groups
535320|NCT00230048|B2|Baseline|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
535321|NCT00230048|B1|Baseline|Assessment Only|This arm answered questions only, but received no intervention.
535322|NCT00230048|P2|Participant Flow|Brief Intervention|Brief computer-delivered intervention following motivational approach, adapted from Motivational Interviewing: Decisional balance, normed feedback, and optional goal-setting.
535323|NCT00230048|P1|Participant Flow|Assessment Only|This arm answered questions only, but received no intervention.
535324|NCT00230048|O2|Outcome|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
535325|NCT00230048|O1|Outcome|Assessment Only|This arm answered questions only, but received no intervention.
535326|NCT00230048|O2|Outcome|Brief Intervention|Assessment plus 20-minute interactive session with computer, designed to be maximally similar to a therapist-delivered motivational session.
535327|NCT00230048|O1|Outcome|Assessment Only|Assessment only, via computer.
535328|NCT00230048|E2|Reported Event|Brief Intervention|Brief computer-delivered intervention following 5As/5Rs approach.
535329|NCT00230048|E1|Reported Event|Assessment Only|This arm answered questions only, but received no intervention.
535330|NCT00230022|B3|Baseline|Total|Total of all reporting groups
535331|NCT00230022|B2|Baseline|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
535332|NCT00230022|B1|Baseline|Brief Computer-delivered Motivational Intervention|Brief computer-delivered intervention in three components: decisional balance, feedback, and optional goal setting.
535333|NCT00230022|P2|Participant Flow|Assessment Only|Only assessment, same as completed by intervention group. No further interaction with computer.
535342|NCT00230009|P2|Participant Flow|Brief Intervention Session|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data. Plus brief therapist-delivered motivational intervention, which was tied to the results of the A-CASI assessment (results from which were viewable immediately by the therapist).
535343|NCT00230009|P1|Participant Flow|Assessment Only|Brief assessment using Audio Computer Assisted Self Interview (A-CASI) technology to obtain the data only.
535344|NCT00230009|O2|Outcome|Brief Intervention Session|
535345|NCT00230009|O1|Outcome|Assessment Only|
535346|NCT00230009|O2|Outcome|Brief Intervention Session|
535347|NCT00230009|O1|Outcome|Assessment Only|
535348|NCT00230009|O2|Outcome|Brief Intervention Session|
535349|NCT00230009|O1|Outcome|Assessment Only|
535350|NCT00230009|O2|Outcome|Brief Intervention Session|
535351|NCT00230009|O1|Outcome|Assessment Only|
535352|NCT00230009|O2|Outcome|Brief Intervention Session|
535353|NCT00230009|O1|Outcome|Assessment Only|
535354|NCT00230009|E2|Reported Event|Brief Intervention Session|
535355|NCT00230009|E1|Reported Event|Assessment Only|
535356|NCT00229970|B4|Baseline|Total|Total of all reporting groups
535357|NCT00229970|B3|Baseline|Placebo|Placebo Intravenous Administration
535358|NCT00229970|B2|Baseline|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
535359|NCT00229970|B1|Baseline|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
535360|NCT00229970|P3|Participant Flow|Placebo|Placebo Intravenous Administration
535361|NCT00229970|P2|Participant Flow|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
535362|NCT00229970|P1|Participant Flow|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
535363|NCT00229970|O3|Outcome|Placebo|Placebo Intravenous Administration
535364|NCT00229970|O2|Outcome|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
535365|NCT00229970|O1|Outcome|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
535366|NCT00229970|E3|Reported Event|Placebo|Placebo Intravenous Administration
535367|NCT00229970|E2|Reported Event|Montelukast 14 mg|Montelukast 14 mg Intravenous Administration
535368|NCT00229970|E1|Reported Event|Montelukast 7 mg|Montelukast 7 mg Intravenous Administration
535369|NCT00229957|B3|Baseline|Total|Total of all reporting groups
535370|NCT00229957|B2|Baseline|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
535371|NCT00229957|B1|Baseline|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
535372|NCT00229957|P2|Participant Flow|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
535373|NCT00229957|P1|Participant Flow|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
535374|NCT00229957|O2|Outcome|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
535375|NCT00229957|O1|Outcome|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
535376|NCT00229957|E2|Reported Event|Control Group|Usual care from the primary health care team which did not include physiotherapy or occupational therapy.
535377|NCT00229957|E1|Reported Event|Intervention Group|A rehabilitation multi-component intervention delivered by a physiotherapist and occupational therapist in a primary care setting included collaborative goal setting for rehabilitation needs, a six-week chronic disease self-management workshop, referral to community programs and a web-based education programme.
535378|NCT00229723|B8|Baseline|Total|Total of all reporting groups
535379|NCT00229723|B7|Baseline|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535380|NCT00229723|B6|Baseline|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535381|NCT00229723|B5|Baseline|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535382|NCT00229723|B4|Baseline|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535383|NCT00229723|B3|Baseline|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535384|NCT00229723|B2|Baseline|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535385|NCT00229723|B1|Baseline|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535386|NCT00229723|P7|Participant Flow|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535387|NCT00229723|P6|Participant Flow|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535388|NCT00229723|P5|Participant Flow|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535389|NCT00229723|P4|Participant Flow|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535390|NCT00229723|P3|Participant Flow|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535391|NCT00229723|P2|Participant Flow|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535520|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535392|NCT00229723|P1|Participant Flow|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535393|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535394|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535395|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535396|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535397|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535398|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535399|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535400|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535401|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535402|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535403|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535404|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535405|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535406|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535407|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535408|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535409|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535410|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535411|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535412|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535413|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535414|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535415|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535416|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535417|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535418|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535419|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535420|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535421|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535422|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535423|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535424|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535425|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535426|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535427|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535428|NCT00229723|O7|Outcome|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535429|NCT00229723|O6|Outcome|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535430|NCT00229723|O5|Outcome|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535431|NCT00229723|O4|Outcome|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535432|NCT00229723|O3|Outcome|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535433|NCT00229723|O2|Outcome|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535434|NCT00229723|O1|Outcome|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535435|NCT00229723|E7|Reported Event|Placebo/500mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535436|NCT00229723|E6|Reported Event|Placebo/250mg|Concomitant placebo (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535437|NCT00229723|E5|Reported Event|500mg/500mg|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by gefitinib 500 mg as maintenance therapy
535438|NCT00229723|E4|Reported Event|250mg/250mg|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by gefitinib 250 mg as maintenance therapy
535439|NCT00229723|E3|Reported Event|500mg/Placebo|Concomitant gefitinib 500 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535440|NCT00229723|E2|Reported Event|250mg/Placebo|Concomitant gefitinib 250 mg (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535441|NCT00229723|E1|Reported Event|Placebo/Placebo|Concomitant placebo (plus cisplatin and radiotherapy) followed by placebo as maintenance therapy
535442|NCT00229658|B3|Baseline|Total|Total of all reporting groups
535443|NCT00229658|B2|Baseline|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535444|NCT00229658|B1|Baseline|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535445|NCT00229658|P2|Participant Flow|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535446|NCT00229658|P1|Participant Flow|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535447|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535448|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535449|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535450|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535451|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535452|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535453|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535454|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535455|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535456|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535457|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535458|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535459|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535460|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535461|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535462|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535463|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535464|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535465|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535466|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535467|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535468|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535469|NCT00229658|O2|Outcome|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535470|NCT00229658|O1|Outcome|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535471|NCT00229658|E2|Reported Event|Type 2 Diabetes|Insulin using patients with Type 2 diabetes
535472|NCT00229658|E1|Reported Event|Type 1 Diabetes|Insulin using patients with Type 1 diabetes
535473|NCT00229619|B1|Baseline|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
535474|NCT00229619|P1|Participant Flow|Rituximab Treated Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
535475|NCT00229619|O1|Outcome|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
535476|NCT00229619|E1|Reported Event|Rituximab Subjects|Rituximab will be given to moderate aplastic anemia (MAA), pure red cell aplasia or Diamond Blackfan anemia subjects. Rituxmiab will be given to evaluate if these bone marrow failure syndrome subjects will have an immune response to the intervention. The subjects will receive 375 mg/ meters squared of rituximab which will be infused intravenously once evey week for a total of 4 doses.
535477|NCT00228813|B1|Baseline|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
535478|NCT00228813|P1|Participant Flow|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
535479|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
535480|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
535481|NCT00228813|O1|Outcome|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants received bone marrow from donors who underwent Granulocyte Colony Stimulating Factor (G-CSF) stimulation prior to bone marrow collection.
535521|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535482|NCT00228813|E1|Reported Event|Granulocyte Colony Stimulating Factor (G-CSF) Stimulation|Participants with hematologic malignancies or bone marrow failure syndrome received in vivo T-cell depleted granulocyte colony stimulating factor (G-CSF) stimulated bone marrow from a partially mismatched related donor.
535483|NCT00228566|B1|Baseline|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
535484|NCT00228566|P1|Participant Flow|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
535485|NCT00228566|O1|Outcome|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
535486|NCT00228566|E1|Reported Event|Armodafinil 150 to 250 mg/Day|Armodafinil 150 to 250 mg once daily in the morning
535487|NCT00228553|B1|Baseline|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
535488|NCT00228553|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
535489|NCT00228553|O1|Outcome|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
535490|NCT00228553|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Armodafinil 100-250 mg: once daily in the morning for patients with obstructive sleep apnea/hypopnea syndrome (OSAHS) or narcolepsy, once daily only on nights worked for patients with shift worker sleep disorder (SWSD)
535491|NCT00229203|B3|Baseline|Total|Total of all reporting groups
535492|NCT00229203|B2|Baseline|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535493|NCT00229203|B1|Baseline|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535494|NCT00229203|P2|Participant Flow|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535495|NCT00229203|P1|Participant Flow|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535496|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535497|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535498|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535499|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535500|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535501|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535502|NCT00229203|O2|Outcome|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535503|NCT00229203|O1|Outcome|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535504|NCT00229203|E2|Reported Event|Plitidepsin + Dexamethasone|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks plus 20 mg of oral dexamethasone every day on days 1 to 4 of each cycle, starting at the same time than the plitidepsin infusion.
535505|NCT00229203|E1|Reported Event|Plitidepsin|Plitidepsin 5 mg/m2 given as a 3-hour i.v. infusion every two weeks.
535506|NCT00228943|B1|Baseline|Entire Sample|"Consented subjects in the entire sample were randomized to one of two groups for the cross-over design study. One group of subjects received a full-strength tryptophan depletion drink during week 1 followed by a half-strength (control) drink week 2. The other group of subjects received a half-strength tryptophan depletion (control) drink during week 1 followed by a full-strength drink week 2.~The final analysis combined groups to compare full strength versus control."
535507|NCT00228943|P1|Participant Flow|Full Strength Acute Tryptophan Depletion and Control|Subjects were randomized to receive both a full-strength acute tryptophan depletion drink and half-strength tryptophan depletion drink (control). Some participants received the full-strength drink first for week 1 and then crossed-over to the half-strength (control) drink for week 2; the other participants received the half-strength (control) drink for week 1 and then crossed over to the full-strength drink for week 2.
535508|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
535509|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
535510|NCT00228943|O2|Outcome|Half-Strength Tryptophan Depletion - Control|
535511|NCT00228943|O1|Outcome|Full Strength Acute Tryptophan Depletion|
535512|NCT00228943|E2|Reported Event|Half-Strength Tryptophan Depletion - Control|No adverse events
535513|NCT00228943|E1|Reported Event|Full Strength Acute Tryptophan Depletion|No adverse events
535514|NCT00228384|B3|Baseline|Total|Total of all reporting groups
535515|NCT00228384|B2|Baseline|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535516|NCT00228384|B1|Baseline|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535517|NCT00228384|P2|Participant Flow|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535518|NCT00228384|P1|Participant Flow|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535519|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535522|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535523|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535524|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535525|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535526|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535527|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535528|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535529|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535530|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535531|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535532|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535533|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535534|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535535|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535536|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535537|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535538|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535539|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535540|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535541|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535542|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535543|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535544|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535545|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535546|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535547|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535548|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535549|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535550|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535551|NCT00228384|O2|Outcome|Bare Nitinol Stent|Subjects randomized to this group received a Bare Nitinol Stent (BNS) per the implanting physician's standard of care.
535552|NCT00228384|O1|Outcome|GORE VIABAHN Endoprosthesis|Subjects randomized to this group received the Gore VIABAHN Endoprosthesis.
535553|NCT00228384|E2|Reported Event|Bare Nitinol Stent|Bare Nitinol Stent
535554|NCT00228384|E1|Reported Event|GORE VIABAHN Endoprosthesis|GORE VIABAHN Endoprosthesis
535555|NCT00227994|B3|Baseline|Total|Total of all reporting groups
535556|NCT00227994|B2|Baseline|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
535557|NCT00227994|B1|Baseline|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
535558|NCT00227994|P2|Participant Flow|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
535559|NCT00227994|P1|Participant Flow|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
535560|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
535561|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
535562|NCT00227994|O2|Outcome|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
535563|NCT00227994|O1|Outcome|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
536669|NCT00217022|O2|Outcome|Placebo|three tablets daily
535564|NCT00227994|E2|Reported Event|Donepezil|"Donepezil for 12 weeks~Donepezil: Participants assigned to receive donepezil will receive 5 mg twice a day for 6 weeks, and then 10 mg twice a day for the next 6 weeks."
535565|NCT00227994|E1|Reported Event|Galantamine|"Galantamine for 12 weeks~Galantamine: Participants assigned to receive galantamine will receive 4 mg twice a day for 4 weeks, 8 mg twice a day for the next 4 weeks, and 12 mg twice a day for the remainder of the study."
535566|NCT00227903|B3|Baseline|Total|Total of all reporting groups
535567|NCT00227903|B2|Baseline|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535568|NCT00227903|B1|Baseline|Brief Advice|Advice and education
535569|NCT00227903|P2|Participant Flow|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535570|NCT00227903|P1|Participant Flow|Brief Advice|Advice and education
535571|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535572|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535573|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535574|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535575|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535576|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535577|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535578|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535579|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535580|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535581|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535582|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535583|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535584|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535585|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535586|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535587|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535588|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535589|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535590|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535591|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535592|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535593|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535594|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535595|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535596|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535597|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535598|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535599|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535600|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535601|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535602|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535603|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535604|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535605|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535606|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535607|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535608|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535609|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535610|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535611|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535612|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535613|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535614|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535615|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535616|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535617|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535618|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535619|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535620|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535621|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535622|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535623|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535624|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535625|NCT00227903|O2|Outcome|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535626|NCT00227903|O1|Outcome|Brief Advice|Advice and education
535627|NCT00227903|E2|Reported Event|MI-CBT|Motivationally-enhanced cognitive behavioral skills counseling
535628|NCT00227903|E1|Reported Event|Brief Advice|Advice and education
535629|NCT00227760|B1|Baseline|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
536670|NCT00217022|O1|Outcome|Budesonide|9 mg daily
535630|NCT00227760|P1|Participant Flow|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
535631|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
535632|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
535633|NCT00227760|O1|Outcome|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
535634|NCT00227760|E1|Reported Event|Treatment (Cediranib Maleate)|"Patients receive cediranib maleate PO QD on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Cediranib Maleate: Given PO~Dynamic Contrast-Enhanced Magnetic Resonance Imaging: Correlative studies~Laboratory Biomarker Analysis: Correlative studies~Pharmacological Study: Correlative studies"
535635|NCT00227721|B1|Baseline|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
535636|NCT00227721|P1|Participant Flow|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
535637|NCT00227721|O1|Outcome|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
535638|NCT00227721|E1|Reported Event|Docetaxel & Gemcitabine Hydrochloride|"Docetaxel, 40 mg/m2, 30 min IV infusion on Days 1 and 8, of a 21 day cycle Gemcitabine hydrochloride, 800mg/m2 30 min IV infusion on Days1 and 8, of a 21 day cycle~Docetaxel: 40 mg/m2, 30 minute IV infusion, Days 1 and 8, Every 21 days~Gemcitabine hydrochloride: 800mg/m2, 30 minute IV infusion, Days 1 and 8, every 21 days"
535639|NCT00227591|B1|Baseline|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
535640|NCT00227591|P1|Participant Flow|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
535641|NCT00227591|O1|Outcome|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
535642|NCT00227591|E1|Reported Event|Lenalidomide|Lenalidomide 10 mg/day plus prednisone X 28 days X 3 cycles
535643|NCT00227370|B3|Baseline|Total|Total of all reporting groups
535644|NCT00227370|B2|Baseline|Treatment Group|Upon randomisation at 3 months, patients remained on Valganciclovir for 9 additional months.
535645|NCT00227370|B1|Baseline|Placebo Group|Upon randomisation at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis
535646|NCT00227370|P2|Participant Flow|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535647|NCT00227370|P1|Participant Flow|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis). 3 months of Valganciclovir was the standard of care for CMV prevention at the time of study initiation. This was the prespecified placebo group/intervention arm.
535648|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535649|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535650|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535651|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535652|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535653|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535654|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535655|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535656|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535657|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535658|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535659|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
536671|NCT00217022|O2|Outcome|Placebo|three tablets daily
535660|NCT00227370|O2|Outcome|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535661|NCT00227370|O1|Outcome|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535662|NCT00227370|E2|Reported Event|Treatment Group|Upon randomization at 3 months, patients remained on Valganciclovir for 9 additional months (extended course prophylaxis).
535663|NCT00227370|E1|Reported Event|Placebo Group|Upon randomization at 3 months, patients discontinued Valganciclovir and received no CMV prophylaxis for the next 9 months (short course prophylaxis)
535664|NCT00227344|B3|Baseline|Total|Total of all reporting groups
535665|NCT00227344|B2|Baseline|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535666|NCT00227344|B1|Baseline|Catheter Ablation|Catheter Ablation
535667|NCT00227344|P2|Participant Flow|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535668|NCT00227344|P1|Participant Flow|Catheter Ablation|Catheter Ablation
535669|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535670|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535671|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535672|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535673|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535674|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535675|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535676|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535677|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535678|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535679|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535680|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535681|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535682|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535683|NCT00227344|O2|Outcome|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535684|NCT00227344|O1|Outcome|Catheter Ablation|Catheter Ablation
535685|NCT00227344|E2|Reported Event|Antiarrhythmic Drug Treatment|Best antiarrhythmic drug according to local practice (amiodarone suggested) throughout the study
535686|NCT00227344|E1|Reported Event|Catheter Ablation|Catheter Ablation
535687|NCT00227305|B1|Baseline|Quetiapine|Quetiapine 400mg/day to 800mg/day
535688|NCT00227305|P1|Participant Flow|Quetiapine|Quetiapine 400mg/day to 800mg/day
535689|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535690|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535691|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535692|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535693|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535694|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535695|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535696|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535697|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535698|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535699|NCT00227305|O1|Outcome|Quetiapine|Quetiapine 400mg/day to 800mg/day
535700|NCT00227305|E1|Reported Event|Quetiapine|Quetiapine 400mg/day to 800mg/day
535701|NCT00227266|B4|Baseline|Total|Total of all reporting groups
535702|NCT00227266|B3|Baseline|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535703|NCT00227266|B2|Baseline|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535704|NCT00227266|B1|Baseline|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535705|NCT00227266|P3|Participant Flow|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535743|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
535787|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535706|NCT00227266|P2|Participant Flow|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535707|NCT00227266|P1|Participant Flow|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535708|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535709|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535710|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535711|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535712|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535713|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535714|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|
535715|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|
535716|NCT00227266|O1|Outcome|Cohort 2 Experimental|"Patients in cohort 2 (SMA standers and walkers) will receive VPA + Carnitine treatment for the entire 12 month time period."
535717|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535718|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535719|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535720|NCT00227266|O3|Outcome|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535721|NCT00227266|O2|Outcome|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535722|NCT00227266|O1|Outcome|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535744|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
535723|NCT00227266|E3|Reported Event|Cohort 2 Standers and Walkers - Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535724|NCT00227266|E2|Reported Event|Cohort 1b Sitters Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor in the liquid form.
535725|NCT00227266|E1|Reported Event|Cohort 1a Sitters Placebo Then Treatment|Dosage of the VPA will start at 10-20 mg/kg/day divided into two or tree doses. The dose will be adjusted to achieve a therapeutic trough level of 50-120 micrograms/ml. VPA will be given in the form of 125 mg sprinkle capsules. Dosage for Carnitor will be 50 mg/kg/day with a maximum dose of 10000 mg/day divided into two doses. Carnitor elixir comes as 500 mg/5 ml. All subjects will be given Carnitor or equivalent placebo in the liquid form.
535726|NCT00226811|B1|Baseline|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535727|NCT00226811|P1|Participant Flow|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535728|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535729|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535730|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535731|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535732|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535733|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535734|NCT00226811|O1|Outcome|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535735|NCT00226811|E1|Reported Event|50 mg Sunitinib|Sunitinib was administered orally daily for 4 weeks followed by a 2-week off-treatment period (Schedule 4 weeks on drug / 2 weeks off) in each cycle. The starting dose was 50 mg daily with provision for dose interruption and/or reduction based on tolerability. All subjects received repeated cycles of sunitinib until disease progression, occurrence of unacceptable toxicity, withdrawal of subject consent, or other withdrawal criteria were met.
535736|NCT00226655|B1|Baseline|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
535737|NCT00226655|P1|Participant Flow|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
535738|NCT00226655|O1|Outcome|hCRF|hCRF administered 1mg bid subcutaneously
535739|NCT00226655|E1|Reported Event|hCRF|All patients will receive hCRF (XERECEPT) 2mg/day
535740|NCT00226590|B1|Baseline|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
535741|NCT00226590|P1|Participant Flow|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
535742|NCT00226590|O1|Outcome|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
536672|NCT00217022|O1|Outcome|Budesonide|9 mg daily
535746|NCT00226590|E1|Reported Event|Combination Therapy|In this trial we adopted the approach of using both induction and concurrent chemotherapy together with TRT planned conformally to a tumor dose of 74 Gy.
535747|NCT00226577|B1|Baseline|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535748|NCT00226577|P1|Participant Flow|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535749|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535750|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535751|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535752|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535753|NCT00226577|O1|Outcome|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535754|NCT00226577|E1|Reported Event|Pre-Surgery Chemotherapy|Pre-Surgery Treatment: Gemcitabine (GemzarR) 1500 mg/m2, and Pemetrexed (AlimtaR) 500 mg/m2. When the chemotherapy treatment was completed, the patient's tumor response was evaluated by a CT scan, pulmonary function test, and another PET scan between days 50 and 63 (during weeks 8 and 9). When there was no growth or spread of the cancer on any of these tests, patients then proceeded to have surgery by week 10 to remove the cancer.
535755|NCT00225784|B1|Baseline|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
535756|NCT00225784|P1|Participant Flow|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
535757|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
535758|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
535759|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
535760|NCT00225784|O2|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (+) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR positive tumors.
535761|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy in EGFR (-) Tumors|Percentage of response to weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy in patients with EGFR negative tumors.
535762|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
535763|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab twice-weekly gemcitabine plus intensity modulated radiotherapy.
535764|NCT00225784|O1|Outcome|Cetuximab, Gemcitabine, Radiotherapy|Weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy.
535765|NCT00225784|E1|Reported Event|Cetuximab/Gemcitabine/Radiotherapy|weekly cetuximab, twice-weekly gemcitabine and intensity modulated radiotherapy
535766|NCT00225732|B3|Baseline|Total|Total of all reporting groups
535767|NCT00225732|B2|Baseline|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535788|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535789|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535790|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535768|NCT00225732|B1|Baseline|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535769|NCT00225732|P2|Participant Flow|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535770|NCT00225732|P1|Participant Flow|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535771|NCT00225732|O2|Outcome|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535772|NCT00225732|O1|Outcome|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535773|NCT00225732|E2|Reported Event|800 mg Intravenous Ibuprofen|The first dose of intravenous ibuprofen will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous ibuprofen will be administered every 6 hours. After receiving 8 doses of intravenous ibuprofen, intravenous ibuprofen will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535774|NCT00225732|E1|Reported Event|Placebo|The first dose of intravenous placebo will be administered at approximately the initiation of skin closure, prior to discharge to the recovery room. Seven subsequent doses of intravenous placebo will be administered every 6 hours. After receiving 8 doses of intravenous placebo, intravenous placebo will continue to be administered every 6 hours up to 5 days post surgery if pain medication is still required and intravenous access is present. All participants were able to receive morphine until approximately 45 minutes before the end of surgery. At that time on only fentanyl will be allow until the end of the surgery. Upon discharge from the operating room, participants will have access to morphine upon patient request or delivered by patient controlled analgesia.
535775|NCT00225498|B1|Baseline|All Participants|Baseline characteristics for all participants prior to randomization are reported because treatment assignment information is not available. That information was not preserved when the orginally planned analyses were not conducted because the enrollment was insufficient for statistically valid results.
535776|NCT00225498|P1|Participant Flow|Ziprasidone|ziprasidone target dose is 160 mg/day
535777|NCT00225498|O1|Outcome|Ziprasidone|ziprasidone target dose is 160 mg/day
535778|NCT00225498|E1|Reported Event|Ziprasidone|
535779|NCT00225277|B3|Baseline|Total|Total of all reporting groups
535780|NCT00225277|B2|Baseline|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535781|NCT00225277|B1|Baseline|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535782|NCT00225277|P2|Participant Flow|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535783|NCT00225277|P1|Participant Flow|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535784|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535785|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535786|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535955|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
535791|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535792|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535793|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535794|NCT00225277|O2|Outcome|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535795|NCT00225277|O1|Outcome|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535796|NCT00225277|E2|Reported Event|Glimepiride QD|Subjects received up to 4 mg Glimepiride (dose optimized for glucose control) for up to 72 weeks.
535797|NCT00225277|E1|Reported Event|Pioglitazone QD|Subjects received up to 45 mg Pioglitazone (dose optimized for glucose control) for up to 72 weeks.
535798|NCT00225251|B3|Baseline|Total|Total of all reporting groups
535799|NCT00225251|B2|Baseline|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535800|NCT00225251|B1|Baseline|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535801|NCT00225251|P2|Participant Flow|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535802|NCT00225251|P1|Participant Flow|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535803|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535804|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535805|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535806|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535807|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535808|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535809|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535810|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535811|NCT00225251|O2|Outcome|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535812|NCT00225251|O1|Outcome|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535813|NCT00225251|E2|Reported Event|Placebo|Placebo comparator, matching appearance with active medication, taken from 1 to 3 tablets per day
535814|NCT00225251|E1|Reported Event|Bupropion XL|"Treatment with active medication (bupropion XL) dose ranging from 150 to 450 mg/day~bupropion XL: Antidepressant medication"
535815|NCT00225212|B1|Baseline|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
535816|NCT00225212|P1|Participant Flow|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
535817|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
535818|NCT00225212|O1|Outcome|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
535819|NCT00225212|E1|Reported Event|Rituximab After ASCT|Rituximab 375 mg/m2 starting 6 weeks after ASCT transplant, and for the 5th and subsequent subjects, a second course at the same dose 6 months after ASCT
535820|NCT00225147|B5|Baseline|Total|Total of all reporting groups
535821|NCT00225147|B4|Baseline|"50 IU/kg Open-label rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT)analysis population, which included all subjects who received 50 IU/kg open-label rhC1INH."
535822|NCT00225147|B3|Baseline|Placebo|"Baseline characteristics were calculated for the modified intention to treat (mITT) analysis population, which included all subjects randomized to the placebo arm."
535823|NCT00225147|B2|Baseline|"50 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included subjects who received 50 IU/kg rhC1INH. One (1) subject was randomized to the 50 IU/kg rhC1INH arm, but did not receive study drug administration and was excluded from the mITT analysis population."
535824|NCT00225147|B1|Baseline|"100 IU/kg rhC1INH"|"Baseline characteristics were calculated for the modified intention to treat (mITT) and per protocol analysis populations, which included all subjects who received 100 IU/kg rhC1INH."
535825|NCT00225147|P4|Participant Flow|"50 IU/kg Open-label rhC1INH"|"Includes all subjects treated with 50 IU/kg open-label rhC1INH in the open-label phase."
535826|NCT00225147|P3|Participant Flow|Placebo|Includes all subjects randomized and treated with Placebo in the double-blind phase
535827|NCT00225147|P2|Participant Flow|"50 IU/kg rhC1INH"|Includes all subjects randomized and treated with 50 IU/kg Recombinant human C1 inhibitor in the double-blind phase
535828|NCT00225147|P1|Participant Flow|"100 IU/kg rhC1INH"|Includes all subjects randomized and treated with 100 IU/kg Recombinant human C1 inhibitor in the double-blind phase
535829|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
535830|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
535831|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg Recombinant human C1 inhibitor arm
535832|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg Recombinant human C1 inhibitor arm
535833|NCT00225147|O4|Outcome|"50 IU/kg Open-label rhC1INH"|Includes all subjects who received 50 IU/kg open-label Recombinant human C1 inhibitor
535834|NCT00225147|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Saline arm
535835|NCT00225147|O2|Outcome|"50 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 50 IU/kg body weight recombinant human C1 Inhibitor arm
535836|NCT00225147|O1|Outcome|"100 IU/kg rhC1INH"|Includes all subjects enrolled and randomized to the 100 IU/kg body weight recombinant human C1 Inhibitor arm
535837|NCT00225147|E4|Reported Event|"50 IU/kg Open-label rhC1INH"|"Includes all subjects receiving 50 IU/kg open-label recombinant human C1 inhibitor and subjects receiving an additional dose of 50 IU/kg rhC1INH within 4 hours after initial administration."
535838|NCT00225147|E3|Reported Event|Placebo|Includes all subjects receiving Saline solution
535839|NCT00225147|E2|Reported Event|50 IU/kg rhC1INH|Includes all subjects receiving 50 IU/kg Recombinant human C1 inhibitor
535840|NCT00225147|E1|Reported Event|100 IU/kg rhC1INH|Includes all subjects receiving 100 IU/kg Recombinant human C1 inhibitor
535841|NCT00225017|B3|Baseline|Total|Total of all reporting groups
535842|NCT00225017|B2|Baseline|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535843|NCT00225017|B1|Baseline|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535844|NCT00225017|P2|Participant Flow|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535845|NCT00225017|P1|Participant Flow|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535846|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535847|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535848|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535849|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535850|NCT00225017|O2|Outcome|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535851|NCT00225017|O1|Outcome|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535852|NCT00225017|E2|Reported Event|Control (Continue Protease Inhibitor)|ARM B: Continue current antiretroviral regimen (single or RTV-boosted PI plus > 2 NRTIs) for 24 weeks
535853|NCT00225017|E1|Reported Event|Atazanavir Switch|"ARM A: Switch current PI to atazanavir 400 mg once daily plus current > 2 nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) for 24 weeks.~Subjects currently on ritonavir (RTV) (400 mg BID or greater) or RTV-boosted PI (<400 mg/day) , or tenofovir (TDF) as backbone NRTI therapy, will switch to ATV 300 mg boosted with RTV 100mg once daily."
535854|NCT00224874|B5|Baseline|Total|Total of all reporting groups
535855|NCT00224874|B4|Baseline|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535856|NCT00224874|B3|Baseline|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535857|NCT00224874|B2|Baseline|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535858|NCT00224874|B1|Baseline|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535859|NCT00224874|P4|Participant Flow|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535860|NCT00224874|P3|Participant Flow|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535861|NCT00224874|P2|Participant Flow|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535862|NCT00224874|P1|Participant Flow|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535863|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535864|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535865|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535866|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535867|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535956|NCT00224120|O2|Outcome|Placebo|Matching placebo capsule once daily with food
535868|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535869|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535870|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535871|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535872|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535873|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535874|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535875|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535876|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535877|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535878|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535879|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535880|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535881|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535882|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535883|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535884|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535885|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535886|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535887|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535888|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535889|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535890|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535891|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535892|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535893|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535894|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535895|NCT00224874|O4|Outcome|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535896|NCT00224874|O3|Outcome|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535897|NCT00224874|O2|Outcome|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535898|NCT00224874|O1|Outcome|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535899|NCT00224874|E4|Reported Event|Pentostatin|Patients received Pentostatin 1.5 mg/m2 intravenously daily on days 1-3 and 15-17.
535900|NCT00224874|E3|Reported Event|Denileukin Diftitox|Patients received Denileukin Diftitox 9 mcg/kg intravenously over 1 hour on days 1, 3, 5, 15, 17, 19.
535901|NCT00224874|E2|Reported Event|Mycophenolate Mofetil|Patients received Mycophenolate Mofetil (MMF) 20 mg/kg (maximum 1 gm) per oral or intravenously twice daily; continue through prednisone taper, then taper MMF over 4 weeks
535902|NCT00224874|E1|Reported Event|Etanercept|Patients received 25 mg Etanercept subcutaneously twice weekly for up to 4 weeks; discontinue if in Complete Response (CR) by 4 weeks
535903|NCT00224770|B4|Baseline|Total|Total of all reporting groups
535904|NCT00224770|B3|Baseline|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535924|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535957|NCT00224120|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
535958|NCT00224120|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
535959|NCT00224120|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
535905|NCT00224770|B2|Baseline|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo®) through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535906|NCT00224770|B1|Baseline|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535907|NCT00224770|P3|Participant Flow|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535908|NCT00224770|P2|Participant Flow|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535909|NCT00224770|P1|Participant Flow|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535910|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535911|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535912|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535913|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535914|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535915|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535916|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535917|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535918|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535919|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535920|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535921|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535922|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535923|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535952|NCT00224120|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
535925|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative targeting technique as the MISTIE arm. No rt-PA administered, and in addition to best medical care.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535926|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535927|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535928|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535929|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535930|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535931|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535932|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535933|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535934|NCT00224770|O3|Outcome|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery (ICES)~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535935|NCT00224770|O2|Outcome|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535936|NCT00224770|O1|Outcome|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535937|NCT00224770|E3|Reported Event|ICES Surgical Management|"Intraoperative stereotactic CT-Guided Endoscopic Surgery~Mechanical intracerebral hemorrhage removal via an endoscope utilizing the same operative-targeting arm as MISTIE arm. Best medical care was provided, but no rt-PA was administered.~This includes 14 intent-to-treat patients, and excludes 4 pilots."
535938|NCT00224770|E2|Reported Event|MISTIE Surgical Management|"Minimally invasive surgery (MIS) with clot lysis with recombinant tissue plasminogen activator (rt-PA).~MIS+Cathflo Activase (drug): The intervention is a comparison of the safety and preliminary effectiveness of investigational minimally invasive surgery to place a catheter into an intracerebral hemorrhage blood clot and subsequent administration in sequential tiers of 0.3 or 1.0mg of rt-PA, CathFlo® through the catheter once every eight hours for up to 72 hours, in addition to best medical care.~This includes 54 intent-to-treat patients, and excludes 27 pilots."
535939|NCT00224770|E1|Reported Event|Medical Management|Standard of care medical management as per American Heart Association (AHA) guidelines.
535940|NCT00224289|B1|Baseline|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
535941|NCT00224289|P1|Participant Flow|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
535942|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
535943|NCT00224289|O1|Outcome|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
535944|NCT00224289|E1|Reported Event|Topical Latanoprost|"All participants will be taking Latanoprost; This study compares efficacy within age groups.~Latanoprost 0.005% : Latanoprost 0.005% ophthalmic solution QHS 8 weeks"
535945|NCT00224133|B1|Baseline|8 mg Silodosin Per Day With Food|
535946|NCT00224133|P1|Participant Flow|8 mg Silodosin Per Day With Food|
535947|NCT00224133|O1|Outcome|8 mg Silodosin Per Day With Food|
535948|NCT00224133|E1|Reported Event|8 mg Silodosin Per Day With Food|
535949|NCT00224120|B3|Baseline|Total|Total of all reporting groups
535950|NCT00224120|B2|Baseline|Placebo|Matching placebo capsule once daily with food
535951|NCT00224120|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
535960|NCT00224107|B3|Baseline|Total|Total of all reporting groups
535961|NCT00224107|B2|Baseline|Placebo|Matching placebo capsule once daily with food
535962|NCT00224107|B1|Baseline|Silodosin|Silodosin 8 mg once daily with food
535963|NCT00224107|P2|Participant Flow|Placebo|Matching placebo capsule once daily with food
535964|NCT00224107|P1|Participant Flow|Silodosin|Silodosin 8 mg once daily with food
535965|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
535966|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
535967|NCT00224107|O2|Outcome|Placebo|Matching placebo capsule once daily with food
535968|NCT00224107|O1|Outcome|Silodosin|Silodosin 8 mg once daily with food
535969|NCT00224107|E2|Reported Event|Placebo|Matching placebo capsule once daily with food
535970|NCT00224107|E1|Reported Event|Silodosin|Silodosin 8 mg once daily with food
535971|NCT00224055|B3|Baseline|Total|Total of all reporting groups
535972|NCT00224055|B2|Baseline|Oral Iron|
535973|NCT00224055|B1|Baseline|IV Iron|
535974|NCT00224055|P2|Participant Flow|Oral Iron|
535975|NCT00224055|P1|Participant Flow|IV Iron|
535976|NCT00224055|O2|Outcome|Oral Iron|
535977|NCT00224055|O1|Outcome|IV Iron|
535978|NCT00224055|O2|Outcome|Oral Iron|
535979|NCT00224055|O1|Outcome|IV Iron|
535980|NCT00224055|E2|Reported Event|Oral Iron|
535981|NCT00224055|E1|Reported Event|IV Iron|
535982|NCT00224042|B3|Baseline|Total|Total of all reporting groups
535983|NCT00224042|B2|Baseline|Oral Iron|
535984|NCT00224042|B1|Baseline|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535985|NCT00224042|P2|Participant Flow|Oral Iron|
535986|NCT00224042|P1|Participant Flow|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535987|NCT00224042|O2|Outcome|Oral Iron|
535988|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535989|NCT00224042|O2|Outcome|Oral Iron|
535990|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535991|NCT00224042|O2|Outcome|Oral Iron|
535992|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535993|NCT00224042|O2|Outcome|Oral Iron|
535994|NCT00224042|O1|Outcome|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535995|NCT00224042|E2|Reported Event|Oral Iron|
535996|NCT00224042|E1|Reported Event|Ferrlecit|Sodium ferric gluconate complex in sucrose injection
535997|NCT00224029|B1|Baseline|Oxybutynin Transdermal System|
535998|NCT00224029|P1|Participant Flow|Oxybutynin Transdermal System|
535999|NCT00224029|O1|Outcome|Oxybutynin Transdermal System|
536000|NCT00224029|E1|Reported Event|Oxybutynin Transdermal System|
536001|NCT00224016|B3|Baseline|Total|Total of all reporting groups
536002|NCT00224016|B2|Baseline|Oral Oxybutynin|Oxybutynin tablets
536003|NCT00224016|B1|Baseline|Oxybutynin TDS|Oxybutynin Transdermal System
536004|NCT00224016|P2|Participant Flow|Oral Oxybutynin|Oxybutynin tablets
536005|NCT00224016|P1|Participant Flow|Oxybutynin TDS|Oxybutynin Transdermal System
536006|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
536007|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
536008|NCT00224016|O2|Outcome|Oral Oxybutynin|Oxybutynin tablets
536009|NCT00224016|O1|Outcome|Oxybutynin TDS|Oxybutynin Transdermal System
536010|NCT00224016|E2|Reported Event|Oral Oxybutynin|Oxybutynin tablets
536011|NCT00224016|E1|Reported Event|Oxybutynin TDS|Oxybutynin Transdermal System
536012|NCT00224003|B1|Baseline|Sodium Ferric Gluconate Complex|
536013|NCT00224003|P1|Participant Flow|Sodium Ferric Gluconate Complex|
536014|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
536015|NCT00224003|O1|Outcome|Sodium Ferric Gluconate Complex|
536016|NCT00223977|B4|Baseline|Total|Total of all reporting groups
536017|NCT00223977|B3|Baseline|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536018|NCT00223977|B2|Baseline|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536019|NCT00223977|B1|Baseline|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536020|NCT00223977|P3|Participant Flow|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536021|NCT00223977|P2|Participant Flow|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536022|NCT00223977|P1|Participant Flow|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536023|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536024|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536025|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536026|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536027|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536028|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536029|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536030|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536031|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536032|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536033|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536034|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536035|NCT00223977|O3|Outcome|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536249|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
536036|NCT00223977|O2|Outcome|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536037|NCT00223977|O1|Outcome|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536038|NCT00223977|E3|Reported Event|Oral Iron|325 mg ferrous sulfate three times daily x 8 weeks
536039|NCT00223977|E2|Reported Event|Sodium Ferric Gluconate Complex 250 mg|250 mg sodium ferric gluconate complex weekly x 4 weeks
536040|NCT00223977|E1|Reported Event|Sodium Ferric Gluconate Complex 125 mg|125 mg sodium ferric gluconate weekly x 8 weeks
536041|NCT00223821|B3|Baseline|Total|Total of all reporting groups
536042|NCT00223821|B2|Baseline|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
536043|NCT00223821|B1|Baseline|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
536044|NCT00223821|P2|Participant Flow|Drug Therapy + Behavioral Training|"drug therapy + behavioral training~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects.~Behavior Training: Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
536045|NCT00223821|P1|Participant Flow|Drug Therapy Alone|"drug therapy alone~Oxybutynin chloride, extended-release: Individually-titrated, extended-release oxybutynin chloride with management of side-effects."
536046|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
536047|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
536048|NCT00223821|O2|Outcome|Drug Therapy + Behavioral Training|"Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
536049|NCT00223821|O1|Outcome|Drug Therapy Alone|Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.
536050|NCT00223821|E2|Reported Event|Arm 2|"drug therapy + behavioral training~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects.~Behavior Training : Behavioral training consists of teaching urge suppression strategies and pelvic floor muscle training."
536051|NCT00223821|E1|Reported Event|Arm 1|"drug therapy alone~Extended release Oxybutynin Chloride : Individually-titrated, extended release oxybutynin chloride with management of side-effects."
536052|NCT00223808|B4|Baseline|Total|Total of all reporting groups
536053|NCT00223808|B3|Baseline|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
536054|NCT00223808|B2|Baseline|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
536055|NCT00223808|B1|Baseline|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
536056|NCT00223808|P3|Participant Flow|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
536057|NCT00223808|P2|Participant Flow|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
536058|NCT00223808|P1|Participant Flow|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
536059|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
536060|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
536061|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
536062|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
536063|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
536064|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
536065|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
536066|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
536067|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
536068|NCT00223808|O3|Outcome|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot. Maximum number of hours = 15.
536069|NCT00223808|O2|Outcome|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy. Maximum number of hours = 30.
536673|NCT00217022|E2|Reported Event|Placebo|three tablets daily
536070|NCT00223808|O1|Outcome|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy. Maximum number of hours = 15.
536071|NCT00223808|E3|Reported Event|Control|Additional usual therapy : 1 hour/day of additional upper limb therapy that includes exposure to, but no manipulation by the robot
536072|NCT00223808|E2|Reported Event|Robot-High|Mechanically-assisted upper limb exercise using MIME (high-dose) : 2 hours/day of robot-assisted therapy in addition to usual physical and occupational therapy
536073|NCT00223808|E1|Reported Event|Robot-Low|Mechanically-assisted upper limb exercise using MIME : 1 hour/day of robot-assisted upper limb therapy in addition to usual physical and occupational therapy
536074|NCT00223795|B1|Baseline|Baseline Characteristics All Subjects|Community-dwelling patients with unilateral knee pain on movement which they scored at >35 mm on a 100-mm visual analogue scale (VAS) for most days of the previous month. Other inclusion criteria included having a weight less than 300 pounds, no cane use for the past 30 days, fulfillment of the American College of Rheumatology criteria for knee OA , and radiographic Kellgren-Lawrence scale knee OA grade > 1. We excluded individuals who had knee trauma or surgery, including arthroscopic surgery, within the past six months, upper body weakness, injury or amputation to the lower extremity joints, symptomatic spine, hip, ankle, or foot disease that would interfere with assessment of the knee, poor health that would impair compliance or assessment such as shortness of breath with exertion, or neurological disease including vestibular dysfunction, or impaired vision.
536075|NCT00223795|P2|Participant Flow|Arm 2 - Cane|Single point cane first, then continue with single point cane
536076|NCT00223795|P1|Participant Flow|Arm 1 - Control/Crossover|No cane first, then single point cane
536077|NCT00223795|O2|Outcome|Arm 2- Cane Users|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants given a cane to use at home during the first intervention period and then for four months after the first intervention period.
536078|NCT00223795|O1|Outcome|Arm 1 - Waiting Control|Study participants with symptomatic knee OA underwent gait analysis while walking with and without a cane at baseline and at end of first intervention period (2 months). Participants not given a cane to use at home during the intervention period. They were given a cane to use for four months after the first intervention period
536079|NCT00223795|E3|Reported Event|Arm 2- Single Point Cane|single point cane for 8 weeks then single point cane for next 4 months
536080|NCT00223795|E2|Reported Event|Arm 1 - Intervention - Crossover to Cane|Given single point cane to use for 4 months following 8 weeks without a cane
536081|NCT00223795|E1|Reported Event|Arm 1: Intervention - no Cane for First 8 Weeks|No cane for first 8 weeks
536082|NCT00223704|B4|Baseline|Total|Total of all reporting groups
536083|NCT00223704|B3|Baseline|HOE 140 Group|Bradykinin B2 receptor antagonist
536084|NCT00223704|B2|Baseline|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
536085|NCT00223704|B1|Baseline|Placebo Group|Placebo was normal saline
536086|NCT00223704|P3|Participant Flow|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536087|NCT00223704|P2|Participant Flow|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536088|NCT00223704|P1|Participant Flow|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536089|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536090|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536091|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536092|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536093|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536094|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536095|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536096|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536097|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536098|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536099|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536100|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536101|NCT00223704|O3|Outcome|HOE 140 Group|HOE 140 (a bradykinin B2 receptor antagonist) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. HOE 140 was given as an intravenous bolus of 22 µg/kg over one-half hour followed by an infusion of 18 µg/kg/hr.
536102|NCT00223704|O2|Outcome|Aminocaproic Acid Group|Aminocaproic acid (an antifibrinolytic drug) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery. Aminocaproic acid was given as an intravenous bolus of 100 mg/kg over one-half hour followed by an infusion of 30 mg/kg/hr.
536103|NCT00223704|O1|Outcome|Placebo Group|Normal saline (placebo) was started in the operating room after induction of anesthesia and before heparinization, continued throughout the bypass period, and discontinued at the end of surgery.
536104|NCT00223704|E3|Reported Event|HOE 140 Group|Bradykinin B2 receptor antagonist
536105|NCT00223704|E2|Reported Event|Aminocaproic Acid Group|Aminocaproic acid is an antifibrinolytic drug
536106|NCT00223704|E1|Reported Event|Placebo Group|Placebo was normal saline
536107|NCT00223652|B3|Baseline|Total|Total of all reporting groups
536108|NCT00223652|B2|Baseline|Treatment as Usual|Treatment as usual control.
536109|NCT00223652|B1|Baseline|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536110|NCT00223652|P2|Participant Flow|Treatment as Usual|Treatment as usual control.
536111|NCT00223652|P1|Participant Flow|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536112|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536113|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536114|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536115|NCT00223652|O1|Outcome|Telephone Cognitive Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536116|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536117|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536118|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536119|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536120|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536121|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536122|NCT00223652|O2|Outcome|Treatment as Usual|Treatment as usual control.
536123|NCT00223652|O1|Outcome|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536124|NCT00223652|E2|Reported Event|Treatment as Usual|Treatment as usual control.
536125|NCT00223652|E1|Reported Event|Telephone-administered Cognitive-Behavioral Therapy|"Telephone cognitive behavioral therapy~Telephone-administered Cognitive-Behavioral Therapy (T-CBT): An initial treatment phase consisting of 12 weekly sessions aimed at reducing symptoms of depression, and a booster phase in which 4 sessions are provided at increasingly greater intervals to target maintenance of treatment gains."
536185|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536126|NCT00223496|B1|Baseline|Aripiprazole|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
536127|NCT00223496|P1|Participant Flow|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
536128|NCT00223496|O1|Outcome|Aripiprazole Plus Divalalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
536129|NCT00223496|E1|Reported Event|Aripiprazole Plus Divalproex ER|Study recruited subjects with bipolar disorder who were currently in a depressed state according to rating scales. Subjects were started on divalproex. After 3 weeks on divalproex if patients were still exhibiting depression symptoms then they were started on aripriprazole in addition to divalproex. Those subject who were no longer in a depressed state were terminated from study. Subjects proceeded in study on both medications and were assessed by physician for depression and mania symtpoms using rating scales, until end of study.
536130|NCT00223236|B3|Baseline|Total|Total of all reporting groups
536131|NCT00223236|B2|Baseline|Placebo|Inactive ingredient matching the active medication in appearance
536132|NCT00223236|B1|Baseline|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536133|NCT00223236|P2|Participant Flow|Placebo|Inactive ingredient matching the active medication in appearance
536134|NCT00223236|P1|Participant Flow|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536135|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
536136|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536137|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
536138|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536139|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
536140|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536141|NCT00223236|O2|Outcome|Placebo|Inactive ingredient matching the active medication in appearance
536142|NCT00223236|O1|Outcome|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536143|NCT00223236|E2|Reported Event|Placebo|Inactive ingredient matching the active medication in appearance
536144|NCT00223236|E1|Reported Event|Citicoline|Citicoline is an over the counter supplement that may have neuroprotective properties and may have antidepressant effects.
536145|NCT00222729|B1|Baseline|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536146|NCT00222729|P1|Participant Flow|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536147|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536148|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536149|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536150|NCT00222729|O1|Outcome|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536151|NCT00222729|E1|Reported Event|Pemetrexed + Bevacizumab|Patients with previously untreated, recurrent, or metastatic SCCHN were treated with pemetrexed 500 mg/m2 and bevacizumab 15 mg/kg
536152|NCT00221299|B4|Baseline|Total|Total of all reporting groups
536153|NCT00221299|B3|Baseline|Parathyroid Hormone Placebo Injections and Risedronate Tables|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
536154|NCT00221299|B2|Baseline|Parathyroid Hormone Injections and Risedronate Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536155|NCT00221299|B1|Baseline|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536186|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536187|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536156|NCT00221299|P4|Participant Flow|Group3-rhPTH-Placebo&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), placebo SC injections of normal saline daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536157|NCT00221299|P3|Participant Flow|Group2-rhPTH&Risedronate|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate tablets (35mg/wk) tablets for one year Second phase (year 2) - continue on risedronate tablets (35mg/wk) for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536158|NCT00221299|P2|Participant Flow|Group1b-rhPTH&RisendronatePlacebo|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - continue on risedronate placebo tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for two years.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536159|NCT00221299|P1|Participant Flow|Group1a-rhPTH&RIS-Placebo(Y1)&RIS(Y2)|"First phase (year 1) - parathyroid hormone (rhPTH 1-34), 20 ug SC injections daily and risedronate placebo tablets for one year Second phase (year 2) - re-randomized to risedronate (35mg/wk) tablets for second year.~Risedronate: One 35mg tab of risedronate/placebo taken once a week for year 1. One 35mg tab of risedronate taken once a week for year 2.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536160|NCT00221299|O3|Outcome|Parathyroid Hormone Placebo&Risedronate|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
536161|NCT00221299|O2|Outcome|Parathyroid Hormone&Risedronate|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536162|NCT00221299|O1|Outcome|Parathyroid Hormone&Risedronate Placebo|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536163|NCT00221299|E3|Reported Event|Parathyroid Hormone Placebo Injections and Risedronate Tablets|"parathyroid hormone (rhPTH 1-34) placebo injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year."
536164|NCT00221299|E2|Reported Event|Parthyroid Hormone Injections and Risedronte Tablets|"Parathyroid hormone (rhPTH 1-34) injections and risedronate tablets for one year~Risedronate: One 35mg tab of risedronate/placebo taken once a week for one year.~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536165|NCT00221299|E1|Reported Event|Parathyroid Hormone Injections and Risedronate Placebo Tablets|"parathyroid hormone (rhPTH 1-34) injections and risedronate placebo tablets for one year~Parathyroid Hormone: This medication comes in a pre packaged 28 day supply pen. Medication is administered once a day by a subcutaneous injection (under the skin) into the thigh or abdomen. For this study, this medication will be taken for one year."
536166|NCT00221195|B3|Baseline|Total|Total of all reporting groups
536167|NCT00221195|B2|Baseline|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
536168|NCT00221195|B1|Baseline|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
536169|NCT00221195|P2|Participant Flow|Prophylaxis First|Patients receive 6 months of prophylaxis therapy with study drug followed by 6 months on-demand therapy with study drug
536170|NCT00221195|P1|Participant Flow|On-demand First|Patients receive 6 months of on-demand therapy with study drug followed by 6 months of prophylaxis therapy with study drug
536171|NCT00221195|O2|Outcome|Bleeds During the Prophylaxis Period|
536172|NCT00221195|O1|Outcome|Bleeds During the On-demand Period|
536173|NCT00221195|E3|Reported Event|Washout Period|
536174|NCT00221195|E2|Reported Event|Prophylaxis Period|
536175|NCT00221195|E1|Reported Event|On-demand Period|
536176|NCT00220961|B3|Baseline|Total|Total of all reporting groups
536177|NCT00220961|B2|Baseline|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536178|NCT00220961|B1|Baseline|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536179|NCT00220961|P2|Participant Flow|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets - 45mg/day tablet"
536180|NCT00220961|P1|Participant Flow|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets - 1 tablet/day"
536181|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536182|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536183|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536184|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536248|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
536188|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536189|NCT00220961|O2|Outcome|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536190|NCT00220961|O1|Outcome|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536191|NCT00220961|E2|Reported Event|Pioglitazone|"Pioglitazone tablet similar to placebo tablet~Pioglitazone: Pioglitazone tablets"
536192|NCT00220961|E1|Reported Event|Placebo|"Placebo tablet similar to pioglitazone tablet~Placebo: Placebo tablets similar to pioglitazone tablets"
536193|NCT00220805|B3|Baseline|Total|Total of all reporting groups
536194|NCT00220805|B2|Baseline|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536195|NCT00220805|B1|Baseline|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536196|NCT00220805|P2|Participant Flow|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536197|NCT00220805|P1|Participant Flow|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536198|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536199|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536200|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536201|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536202|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536203|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536204|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536205|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536206|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536207|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536208|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536209|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536210|NCT00220805|O2|Outcome|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536211|NCT00220805|O1|Outcome|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536212|NCT00220805|E2|Reported Event|Placebo|Albumin (Human) 25%, United States Pharmacopeia (USP)
536213|NCT00220805|E1|Reported Event|IGIV-C 10%|Immune Globulin Intravenous [Human], 10% Caprylate/Chromatography Purified
536214|NCT00220779|B4|Baseline|Total|Total of all reporting groups
536215|NCT00220779|B3|Baseline|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
536216|NCT00220779|B2|Baseline|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
536217|NCT00220779|B1|Baseline|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
536218|NCT00220779|P3|Participant Flow|Placebo (0.1% Albumin) 4 mL/kg Body Weight/Infusion|Immune globulin (intravenous) (IGIV)
536219|NCT00220779|P2|Participant Flow|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
536220|NCT00220779|P1|Participant Flow|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg Body Weight)|Immune globulin (intravenous) (IGIV)
536221|NCT00220779|O3|Outcome|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
536222|NCT00220779|O2|Outcome|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
536223|NCT00220779|O1|Outcome|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
536224|NCT00220779|E3|Reported Event|Placebo (0.1% Albumin) 4 mL/kg bw/Infusion|
536225|NCT00220779|E2|Reported Event|IGIV-C 0.4 g/kg bw/Infusion (4 mL/kg bw)|
536226|NCT00220779|E1|Reported Event|IGIV-C 0.2 g/kg bw/Infusion (2 mL/kg bw)|
536227|NCT00220740|B3|Baseline|Total|Total of all reporting groups
536228|NCT00220740|B2|Baseline|Placebo|.1% albumin, 2 g/kg loading dose, followed by 1 g/kg maintenance dose
536229|NCT00220740|B1|Baseline|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
536230|NCT00220740|P2|Participant Flow|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
536231|NCT00220740|P1|Participant Flow|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
536232|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
536233|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
536234|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
536235|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
536236|NCT00220740|O2|Outcome|Placebo|.1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose
536237|NCT00220740|O1|Outcome|IGIV-C|2 g/kg loading dose, followed by 1 g/kg maintenance dose
536238|NCT00220740|O2|Outcome|Placebo|
536239|NCT00220740|O1|Outcome|IGIV-C|
536240|NCT00220740|E2|Reported Event|Placebo|".1% albumin; 2g/kg loading dose and 1 g/kg maintenance dose.~A total of 95 subjects were exposed to Placebo across all three treatments/periods."
536241|NCT00220740|E1|Reported Event|IGIV-C|"2 g/kg loading dose, followed by 1 g/kg maintenance dose.~A total of 113 subjects were exposed to IGIV-C across all three treatments/periods."
536242|NCT00220727|B3|Baseline|Total|Total of all reporting groups
536243|NCT00220727|B2|Baseline|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
536244|NCT00220727|B1|Baseline|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
536245|NCT00220727|P2|Participant Flow|IGIV-C, 10% - 0.14/0.08 mL/kg/Min|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
536246|NCT00220727|P1|Participant Flow|IGIV-C, 10% - 0.08/0.14 mL/kg/Min|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
536247|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
536250|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
536251|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
536252|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
536253|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Rapid Infusion Rate IGIV-C (0.14 mL/kg/min);
536254|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Slow Infusion Rate IGIV-C (0.08 mL/kg/min);
536255|NCT00220727|O2|Outcome|IGIV-C, 10% (0.14 mL/kg/Min)|Infusion #1 (Week 0) IGIV-C (0.14 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.08 mL/kg/min)
536256|NCT00220727|O1|Outcome|IGIV-C, 10% (0.08 mL/kg/Min)|Infusion #1 (Week 0 IGIV-C (0.08 mL/kg/min); Infusion #2 (Week <6) IGIV-C (0.14 mL/kg/min)
536257|NCT00220727|E2|Reported Event|IGIV-C, 10% - 0.14 mL/kg/Min|IGIV-C (0.14 mL/kg/min);
536258|NCT00220727|E1|Reported Event|IGIV-C, 10% - 0.08 mL/kg/Min|IGIV-C (0.08 mL/kg/min);
536259|NCT00220701|B3|Baseline|Total|Total of all reporting groups
536260|NCT00220701|B2|Baseline|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536261|NCT00220701|B1|Baseline|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536262|NCT00220701|P2|Participant Flow|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536263|NCT00220701|P1|Participant Flow|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536264|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536265|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536266|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536267|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536268|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536269|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536270|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536271|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536272|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536273|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536274|NCT00220701|O2|Outcome|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536275|NCT00220701|O1|Outcome|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536276|NCT00220701|E2|Reported Event|Placebo|"inactive comparator~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536277|NCT00220701|E1|Reported Event|Escitalopram|"Escitalopram (brand name Lexapro) is an antidepressant medication taken once per day, dosing from 10 to 20 milligrams per day.~Lexapro (escitalopram): antidepressant drug selective serotonin reuptake inhibitor (SSRI)"
536278|NCT00220636|B1|Baseline|Aripiprazole|aripiprazole augmentation treatment
536279|NCT00220636|P1|Participant Flow|Aripiprazole|aripiprazole augmentation treatment
536280|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
536281|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
536282|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment for treatment resistant depression
536283|NCT00220636|O1|Outcome|Aripiprazole|aripiprazole augmentation treatment
536284|NCT00220636|E1|Reported Event|Aripiprazole|aripiprazole augmentation treatment
536285|NCT00219557|B4|Baseline|Total|Total of all reporting groups
536286|NCT00219557|B3|Baseline|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536287|NCT00219557|B2|Baseline|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536288|NCT00219557|B1|Baseline|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536289|NCT00219557|P3|Participant Flow|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536290|NCT00219557|P2|Participant Flow|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536358|NCT00219349|P1|Participant Flow|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
536359|NCT00219349|O1|Outcome|Patients Who Started Escitalopram|Patients who completed the CBT phase and started escitalopram phase treatment
536291|NCT00219557|P1|Participant Flow|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536292|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536293|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536294|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536295|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536296|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536297|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536298|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536299|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536300|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536301|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536302|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536303|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536304|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536305|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536306|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536307|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536308|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536309|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536310|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536311|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536312|NCT00219557|O1|Outcome|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536313|NCT00219557|O2|Outcome|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536314|NCT00219557|O1|Outcome|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536315|NCT00219557|E3|Reported Event|Gemcitabine|Gemcitabine 1000 mg/m^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536316|NCT00219557|E2|Reported Event|Axitinib + Gemcitabine|Axitinib (AG-013736) 5 mg tablet orally twice daily (BID) from Day 1 of Cycle 1 (28 days) and all subsequent cycles (28 days). Gemcitabine 1000 mg/m^2 30-minute infusion on Day 1, 8 and 15 of each cycle.
536317|NCT00219557|E1|Reported Event|Axitinib + Gemcitabine (Phase 1 Lead-In)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 4 weeks. Gemcitabine 1000 milligram/square meter (mg/m^2) 30 minutes intravenous (IV) infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.
536360|NCT00219349|E1|Reported Event|Group 1|all subject entered
536361|NCT00219284|B3|Baseline|Total|Total of all reporting groups
536445|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536318|NCT00219544|B1|Baseline|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536319|NCT00219544|P2|Participant Flow|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536320|NCT00219544|P1|Participant Flow|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536321|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536322|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536323|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536324|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536325|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536326|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536327|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536328|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536329|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536330|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536331|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536332|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536333|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536334|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536335|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536405|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536446|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
536336|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536337|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536338|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536339|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536340|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536341|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536342|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536343|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536344|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536345|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536346|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536347|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536348|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536349|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536350|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536351|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536352|NCT00219544|O2|Outcome|Placebo|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536353|NCT00219544|O1|Outcome|Pregabalin|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day), starting at 150 mg/day for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatment phase.
536354|NCT00219544|E3|Reported Event|Placebo Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to placebo received pregabalin 150 mg for 7 days and then placebo for 28 days.
536355|NCT00219544|E2|Reported Event|Pregabalin Double-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed. Subjects who responded during the single-blind phase and were randomized to pregabalin entered the double-blind phase with 35 days of dose achieved at the end of the single-blind treatent phase.
536356|NCT00219544|E1|Reported Event|Pregabalin Single-blind Phase|subjects entered single-blind phase with 28 days of single-blind flexible pregabalin doses (150 to 600 mg/day) for ≥4 days, then dose adjustment as needed.
536357|NCT00219349|B1|Baseline|Cognitive-behavioral Therapy|14 weekly sessions of individual cognitive-behavioral therapy
536674|NCT00217022|E1|Reported Event|Budesonide|9 mg daily
536362|NCT00219284|B2|Baseline|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536363|NCT00219284|B1|Baseline|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536364|NCT00219284|P2|Participant Flow|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536365|NCT00219284|P1|Participant Flow|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536366|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536367|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536368|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536369|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536370|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536371|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536406|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536407|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536372|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536373|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536374|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536375|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536376|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536377|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536378|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536379|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536380|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536381|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536408|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536447|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536382|NCT00219284|O2|Outcome|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536383|NCT00219284|O1|Outcome|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536384|NCT00219284|E2|Reported Event|Delayed Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched 4 weeks after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536385|NCT00219284|E1|Reported Event|Immediate Switch|Carbidopa/levodopa/entacapone was administered in 1 of 3 dose combinations: 12.5/50/200 mg, 25/100/200 mg, or 37.5/150/200 mg. The selected combination dose contained the same doses of carbidopa and levodopa the patient was receiving prior to switching to carbidopa/levodopa/entacapone. Patients were switched the day after randomization from combined carbidopa/levodopa to combined carbidopa/levodopa/entacapone. Patients received the same doses of carbidopa (12.5, 25.0, or 37.5 mg) and levodopa (50, 100, or 150 mg) they were receiving prior to the switch, combined with 200 mg of entacapone. The frequency of doses per day prior to the switch remained the same after the switch.
536386|NCT00219141|B4|Baseline|Total|Total of all reporting groups
536387|NCT00219141|B3|Baseline|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536388|NCT00219141|B2|Baseline|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536389|NCT00219141|B1|Baseline|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536390|NCT00219141|P3|Participant Flow|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536391|NCT00219141|P2|Participant Flow|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536392|NCT00219141|P1|Participant Flow|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536393|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536394|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536395|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536396|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536397|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536398|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536399|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536400|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536401|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536402|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536403|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536404|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536448|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
536409|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536410|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536411|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536412|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536413|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536414|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536415|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536416|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536417|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536418|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536419|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536420|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536421|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536422|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536423|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536424|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536425|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536426|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536427|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536428|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536429|NCT00219141|O3|Outcome|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536430|NCT00219141|O2|Outcome|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536431|NCT00219141|O1|Outcome|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536432|NCT00219141|E3|Reported Event|Aliskiren/Losartan 300/100 mg|Patients in this arm initially received 150 mg of aliskiren in combination with 50 mg of losartan for two weeks and were then force-titrated up to 300 mg of aliskiren in combination with 100 mg of losartan where they remained for 34 weeks.
536433|NCT00219141|E2|Reported Event|Losartan 100 mg|Patients in this arm initially received 50 mg of losartan for two weeks and were then force-titrated up to 100 mg of losartan where they remained for 34 weeks.
536434|NCT00219141|E1|Reported Event|Aliskiren 300 mg|Patients in this arm initially received 150 mg of aliskiren for two weeks and were then force-titrated up to 300 mg of aliskiren where they remained for 34 weeks.
536435|NCT00218634|B3|Baseline|Total|Total of all reporting groups
536436|NCT00218634|B2|Baseline|ETAU|Enhanced Treatment as Usual
536437|NCT00218634|B1|Baseline|CBT-AD|Cognitive behavioral therapy for adherence and depression
536438|NCT00218634|P2|Participant Flow|ETAU|Enhanced Treatment as Usual
536439|NCT00218634|P1|Participant Flow|CBT-AD|Cognitive behavioral therapy for adherence and depression
536440|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
536441|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536442|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
536443|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536444|NCT00218634|O2|Outcome|ETAU|Enhanced Treatment as Usual
536675|NCT00216736|B3|Baseline|Total|Total of all reporting groups
536449|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536450|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
536451|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536452|NCT00218634|O2|Outcome|Enhanced Treatment as Usual|Enhanced treatment as usual (ETAU).
536453|NCT00218634|O1|Outcome|Cognitive Behavioral Therapy for Adherence and Depression|Cognitive behavioral therapy focusing on treating depression and adherence to medication (CBT-AD).
536454|NCT00218634|O2|Outcome|ETAU|Enhanced treatment as usual
536455|NCT00218634|O1|Outcome|CBT-AD|Cognitive behavioral therapy for adherence and depression
536456|NCT00218634|E2|Reported Event|ETAU|Enhanced Treatment as Usual
536457|NCT00218634|E1|Reported Event|CBT-AD|Cognitive behavioral therapy for adherence and depression
536458|NCT00218543|B1|Baseline|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
536459|NCT00218543|P1|Participant Flow|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
536460|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
536461|NCT00218543|O1|Outcome|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
536462|NCT00218543|E1|Reported Event|Atomoxetine|Initially, atomoxetine was administered at 20 mg/day for three days. This dose was then increased to 40 mg/day for four days. During the second week of the trial, the dose was increased to 60 mg/day and later increased to 80 mg/day at the start of Week 3. Patients were then maintained at 80 mg per day for four weeks. At the beginning of Week 7, patients were maintained at 80 mg/day or increased to the maximal dose of 100 mg/day if there was less than a 50% reduction of ADHD symptoms (as determined by the Adult ADHD Rating Scale; Murphy, 1996) and if the patients were tolerating the medication well. They were then maintained at 80 mg/day or 100 mg/day for the remaining six weeks of the trial. All patients received two capsules to be taken once a day in the morning.
536463|NCT00218465|B3|Baseline|Total|Total of all reporting groups
536464|NCT00218465|B2|Baseline|Placebo|Placebo group for 5 week relapse prevention trial.
536465|NCT00218465|B1|Baseline|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536466|NCT00218465|P2|Participant Flow|Placebo|Placebo group for 5 week relapse prevention trial.
536467|NCT00218465|P1|Participant Flow|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536468|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
536469|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536470|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
536471|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536472|NCT00218465|O2|Outcome|Placebo|Placebo group for 5 week relapse prevention trial.
536473|NCT00218465|O1|Outcome|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536474|NCT00218465|E2|Reported Event|Placebo|Placebo group for 5 week relapse prevention trial.
536475|NCT00218465|E1|Reported Event|816 Group|Glycine Antagonist GW468816, 200 mg/day, for a 5-week trial.
536476|NCT00218439|B3|Baseline|Total|Total of all reporting groups
536477|NCT00218439|B2|Baseline|Paroxetine First 4 Weeks, Then Placebo for 4 Weeks|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
536478|NCT00218439|B1|Baseline|Placebo First 4 Weeks, Then Paroxetine for 4 Weeks|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
536479|NCT00218439|P2|Participant Flow|Paroxetine (4 Weeks) the Placebo (4 Weeks)|Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of first intervention period, placebo once daily in second intervention period
536582|NCT00217971|B2|Baseline|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
536480|NCT00218439|P1|Participant Flow|Placebo (4 Weeks) Then Paroxetine (4 Weeks)|Placebo once daily in first intervention period and Paroxetine 10 mg daily for 1 week then increased to 20 mg once daily for remainder of second intervention period
536481|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
536482|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma norepinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
536483|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
536484|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in plasma epinephrine concentrations from Resting period to those observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
536485|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
536486|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in heart rate from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
536487|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in diastolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
536488|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in diastolic blood pressure fom Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
536489|NCT00218439|O2|Outcome|After 4 Weeks of Paroxetine|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of paroxetine (1 week of 10 mg once daily followed by 3 weeks of 20 mg once daily)
536490|NCT00218439|O1|Outcome|After 4 Weeks of Placebo|Change in systolic blood pressure from Resting period to that observed during a speech delivered immediately after smoking a cigarette in those receiving 4 weeks of placebo
536491|NCT00218439|E2|Reported Event|During 4 Weeks of Paroxetine|Participants received paroxetine 10 mg once daily for 1 week followed by 20 mg once daily for 3 weeks
536492|NCT00218439|E1|Reported Event|During 4 Weeks of Placebo|Participants receive placebo daily for 4 weeks
536493|NCT00218335|B5|Baseline|Total|Total of all reporting groups
536494|NCT00218335|B4|Baseline|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536495|NCT00218335|B3|Baseline|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536496|NCT00218335|B2|Baseline|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536497|NCT00218335|B1|Baseline|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536498|NCT00218335|P4|Participant Flow|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536499|NCT00218335|P3|Participant Flow|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536500|NCT00218335|P2|Participant Flow|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536501|NCT00218335|P1|Participant Flow|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536502|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536503|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536504|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536505|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536583|NCT00217971|B1|Baseline|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
536584|NCT00217971|P2|Participant Flow|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
536506|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536507|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536508|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536509|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536510|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536511|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536512|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536513|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536514|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536515|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536516|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536517|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536518|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536519|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536520|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536521|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536522|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536523|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536524|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536525|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536526|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536527|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536528|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536529|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536530|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536531|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536532|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536533|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536534|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536535|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536536|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536537|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536538|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536539|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536540|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536541|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536542|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536543|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536544|NCT00218335|O2|Outcome|Control Participants|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536545|NCT00218335|O1|Outcome|Intervention Participants|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536546|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536547|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536548|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536549|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536550|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536551|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536552|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536585|NCT00217971|P1|Participant Flow|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
536553|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536554|NCT00218335|O4|Outcome|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536555|NCT00218335|O3|Outcome|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536556|NCT00218335|O2|Outcome|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536557|NCT00218335|O1|Outcome|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536558|NCT00218335|E4|Reported Event|Risk Network Members|Individuals from the personal social networks of the index participants who inject or are the sexual partners of the index participant
536559|NCT00218335|E3|Reported Event|Non-Randomized Baseline Index Participants|Those Index participants that completed a baseline interview but were not randomized into the intervention or control condition.
536560|NCT00218335|E2|Reported Event|Control Condition|Index participants in the control condition attended groups that focused on injection drug-use related topics (e.g. HIV testing, Hepatitis C and drug overdose). The sessions were educational and did not include skills training. The control condition consisted of five group-based sessions.
536561|NCT00218335|E1|Reported Event|Intervention Condition|Index participants in the intervention condition were trained to be Health Educators. The intervention focused on HIV risk reduction by teaching knowledge and skills to reduce injection, drug splitting, and sex risk, and by teaching communication skills to conduct outreach to personal risk network members. The intervention consisted of five group-based sessions, one individual session, and one dyad session with a risk network member.
536562|NCT00218296|B3|Baseline|Total|Total of all reporting groups
536563|NCT00218296|B2|Baseline|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536564|NCT00218296|B1|Baseline|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536565|NCT00218296|P2|Participant Flow|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated by using nicotine lozenge or ST brand switching resulting in reduced nicotine exposure.
536566|NCT00218296|P1|Participant Flow|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks of nicotine patch and behavioral counseling during the 6 week intervention period.
536567|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536568|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536569|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536570|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536571|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536572|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536573|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536574|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536575|NCT00218296|O2|Outcome|Reduction Group|Reduction group subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date. Reduction is facilitated using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536576|NCT00218296|O1|Outcome|Usual Care Group|Usual Care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536577|NCT00218296|O2|Outcome|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536578|NCT00218296|O1|Outcome|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536579|NCT00218296|E2|Reported Event|Reduction Group|Subjects are instructed to reduce their tobacco use by 50% and then 75% over 6 weeks prior to quit date using nicotine lozenge or brand switching resulting in reduced nicotine exposure.
536580|NCT00218296|E1|Reported Event|Usual Care Group|Usual care consisted of setting an immediate quit date and receiving 2 weeks nicotine patch and behavioral counseling during the intervention period.
536581|NCT00217971|B3|Baseline|Total|Total of all reporting groups
536586|NCT00217971|O2|Outcome|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
536587|NCT00217971|O1|Outcome|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
536588|NCT00217971|E2|Reported Event|Placebo|Placebo:2 placebo capsules dosed bid for a total of 4 capsules per day
536589|NCT00217971|E1|Reported Event|Dronabinol|Dronabinol: 20mg bid for a daily maximum dose of 40mg.
536590|NCT00217724|B1|Baseline|Entire Study Population|Includes those randomized to Arms 1 and 2 in both course 1 and 2.
536591|NCT00217724|P2|Participant Flow|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
536592|NCT00217724|P1|Participant Flow|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days starting day 2 of course 1 during Paclitaxel treatment.
536593|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536594|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536595|NCT00217724|O2|Outcome|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536596|NCT00217724|O1|Outcome|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536597|NCT00217724|E2|Reported Event|Oral Placebo x 4 Days|Oral placebo 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536598|NCT00217724|E1|Reported Event|Oral Glutamine x 4 Days|Oral glutamine 10g powder (dissolved in 8 oz orange juice) three times daily for 4 days.
536599|NCT00217672|B1|Baseline|Docetaxel + Bevacizumab|"docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.~A total of 104 participants were screened for the study. Twenty six participants did not meet eligibility criteria and 2 withdrew consent.~Seventy six participants were registered to the Treatment Period, 7 to arm A and 69 to arm B. Six out of 7 participants randomized to arm A elected to cross over to arm B once bevacizumab became available. Two out of the 69 participants randomized to arm B were found ineligible and taken off study before receiving treatment. As a result, the efficacy analysis was performed on 67 patients."
536600|NCT00217672|P2|Participant Flow|Docetaxel|docetaxel: 75 mg/m2 IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536601|NCT00217672|P1|Participant Flow|Docetaxel+Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536602|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536603|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536604|NCT00217672|O1|Outcome|Docetaxel + Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536605|NCT00217672|E1|Reported Event|Docetaxel and/or Bevacizumab|docetaxel: 75 mg/m2 IV q3 weeks. Bevacizumab: 15mg/kg IV q3 weeks. Subjects continue on dosing until they experience unacceptable toxicity, disease progression, or withdrawal of patient consent.
536606|NCT00217620|B1|Baseline|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536607|NCT00217620|P1|Participant Flow|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536608|NCT00217620|O1|Outcome|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536609|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536610|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536611|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536612|NCT00217620|O4|Outcome|Total|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536613|NCT00217620|O3|Outcome|Vascular Sarcomas|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536614|NCT00217620|O2|Outcome|Liposarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536658|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection FISH Positive Positive|FISH cytology results were positive prior to therapy
536676|NCT00216736|B2|Baseline|Dexamethasone|
536677|NCT00216736|B1|Baseline|Placebo|
536615|NCT00217620|O1|Outcome|Leiomyosarcoma|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536616|NCT00217620|E1|Reported Event|Sorafenib (BAY 43-9006)|Sorafenib (BAY 43-9006) 800 mg per day divided into two equal doses of 400 mg by mouth (PO). Patients received the drug continuously on a daily basis until progression; each cycle is 28 days. All eligible patients who received treatment were included in baseline measures.
536617|NCT00217581|B1|Baseline|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
536618|NCT00217581|P1|Participant Flow|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
536619|NCT00217581|O1|Outcome|Docetaxel, Oxaliplatin & Bevacizumab|"Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min + or - 10 mins.~Bevacizumab: Must be administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 + or - 15 minutes. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 + or - 10 minutes."
536620|NCT00217581|E1|Reported Event|Docetaxel, Oxaliplatin & Bevacizumab|"Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; 1st cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Bevacizumab: Administered 1st before Docetaxel & Oxaliplatin.7.5 mg/kg, IV, day 1 of each cycle; During the first cycle, bevacizumab will be delivered over 90 +/- 15 mins. If the 1st IV infusion is tolerated w/o infusion-associated adverse events, the 2nd infusion may be delivered over 60 +/- 10 mins. If the 60 min infusion is well tolerated, all subsequent infusions may be delivered over 30 min +/- 10 mins.~Docetaxel: Must be administered 2nd after Bevacizumab then Oxaliplatin.70 mg/m(2), IV over 60 minutes, day 1 of each cycle;"
536621|NCT00217464|B1|Baseline|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
536622|NCT00217464|P1|Participant Flow|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
536623|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
536624|NCT00217464|O1|Outcome|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
536625|NCT00217464|E1|Reported Event|Fulvestrant|"Patients receive fulvestrant intramuscularly on days 0, 14, and 28. Treatment repeats once a month in the absence of disease progression or unacceptable toxicity.~fulvestrant: intramuscularly"
536626|NCT00217438|B3|Baseline|Total|Total of all reporting groups
536627|NCT00217438|B2|Baseline|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536628|NCT00217438|B1|Baseline|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536659|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection FISH Polysomy Negative|FISH cytology results prior to therapy were negative
536660|NCT00217087|O2|Outcome|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
536661|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
536629|NCT00217438|P2|Participant Flow|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536630|NCT00217438|P1|Participant Flow|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536631|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536632|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536633|NCT00217438|O2|Outcome|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536634|NCT00217438|O1|Outcome|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536635|NCT00217438|E2|Reported Event|Arm II (Low Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine as in arm I and melphalan as in arm I at a lower dose.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536636|NCT00217438|E1|Reported Event|Arm I (High Dose Melphalan, Amifostine Trihydrate, Transplant)|"INDUCTION THERAPY:~Patients receive amifostine IV over 3-5 minutes on days -3 and -2 followed by high-dose melphalan IV over 15-30 minutes on day 2.~AUTOLOGOUS OR SYNGENEIC PBSCT: At least 20 hours after completion of melphalan, patients undergo autologous or syngeneic PBSCT on day 0.~Patients undergo restaging of the disease between days 80-90. Patients with progressive disease are removed from the study. Patients who achieve a CR or near-CR can proceed to optional maintenance therapy. Patients who do not achieve a CR or near-CR may undergo additional induction therapy as in arm I followed by a second autologous or syngeneic PBSCT.~Patients again undergo restaging of the disease 80-90 days later. Patients with progressive disease are removed from the study. Patients without progressive disease can proceed to maintenance therapy."
536662|NCT00217087|E2|Reported Event|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
536663|NCT00217087|E1|Reported Event|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
536664|NCT00217022|B3|Baseline|Total|Total of all reporting groups
536637|NCT00217425|B1|Baseline|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
536638|NCT00217425|P1|Participant Flow|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
536639|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
536640|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
536641|NCT00217425|O1|Outcome|Treatment (A-CHOP Followed by MA)|Patients receive 6-8 cycles of bevacizumab and combination chemotherapy comprising cyclophosphamide, doxorubicin, vincristine, and prednisone (A-CHOP) followed by 8 cycles of maintenance bevacizumab (MA), as outlined below. Bevacizumab 15 mg/kg is administered on day 1 over 90 min (first cycle), 60 min (second cycle) and 30 min for the subsequent cycles. CHOP (cyclophosphamide 750 mg/m 2 ; doxorubicin 50 mg/m 2 ; vincristine 1.4 mg/m2 [max. 2 mg]; prednisone 100 mg daily on days 1-5) is administered on day 1 of a 21-day cycle. Radiographic response is assessed after cycles 3, 6 and 8 of ACHOP and after cycle 8 of MA. Patients receive six cycles of ACHOP if they achieve a complete response (CR) after three cycles, eight cycles if they achieve a partial response (PR) after three cycles. Non-responders are removed from the study. ACHOP responders receive maintenance bevacizumab 15 mg/kg every 21 days for eight cycles.
536642|NCT00217425|E1|Reported Event|Treatment (ACHOP Followed by MA)|Adverse events in all treated patients regardless of eligibility.
536643|NCT00217399|B1|Baseline|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
536644|NCT00217399|P1|Participant Flow|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
536645|NCT00217399|O1|Outcome|Circulating Endothelial Cells|All patients received sorafenib and anastrozole. Blood was drawn prior to beginning treatment and at set time points to analyze for circulating endothelial cells by flow cytometry
536646|NCT00217399|O1|Outcome|Sorefenib and Anastrozole|All patients receive sorafenib (400mg by mouth twice daily) and anastrazole (1 mg by mouth daily)
536647|NCT00217399|O1|Outcome|Sorafenib and Anastrozole|All patients receive sorafenib and anastrozole.
536648|NCT00217399|E1|Reported Event|Sorafenib and Anastrozole|A single arm of 35 patients with advanced or metastatic breast cancer receiving a combination of sorafenib and anastrozole.
536649|NCT00217087|B3|Baseline|Total|Total of all reporting groups
536650|NCT00217087|B2|Baseline|Photodynamic Therapy|patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
536651|NCT00217087|B1|Baseline|Endoscopic Mucosl Resection|patients will undergo endoscopic mucosal resection at time of endoscopy if indicated
536652|NCT00217087|P2|Participant Flow|Photodynamic Therapy|Patients will have endoscopic mucosal resection (if indicated at time of endoscopy) followed by photodynamic therapy.
536653|NCT00217087|P1|Participant Flow|Endoscopic Mucosal Resection|Patients will undergo endoscopic mucosal resection at time of endoscopy if indicated.
536654|NCT00217087|O2|Outcome|Endoscopic Mucosal Resection and Photodynamic Therapy|Patients will have EMR (if indicated at time of endoscopy) followed by photodynamic therapy
536655|NCT00217087|O1|Outcome|Endoscopic Mucosal Resection|Patients will undergo EMR at time of endoscopy if indicated.
536656|NCT00217087|O4|Outcome|Photodynamic Therapy FISH NEGATIVE|FISH cytology results prior to therapy were negative
536657|NCT00217087|O3|Outcome|Photodynamic Therapy FISH POSITIVE|FISH cytology results were positive prior to therapy
536665|NCT00217022|B2|Baseline|Placebo|three tablets daily
536678|NCT00216736|P2|Participant Flow|Dexamethasone|
536679|NCT00216736|P1|Participant Flow|Placebo|
536680|NCT00216736|O2|Outcome|Dexamethasone|
536681|NCT00216736|O1|Outcome|Placebo|
536682|NCT00216736|O2|Outcome|Dexamethasone|
536683|NCT00216736|O1|Outcome|Placebo|
536684|NCT00216736|O2|Outcome|Dexamethasone|
536685|NCT00216736|O1|Outcome|Placebo|
536686|NCT00216736|O2|Outcome|Dexamethasone|
536687|NCT00216736|O1|Outcome|Placebo|
536688|NCT00216736|E2|Reported Event|Dexamethasone|
536689|NCT00216736|E1|Reported Event|Placebo|
536690|NCT00216671|B3|Baseline|Total|Total of all reporting groups
536691|NCT00216671|B2|Baseline|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536692|NCT00216671|B1|Baseline|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536693|NCT00216671|P2|Participant Flow|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
536694|NCT00216671|P1|Participant Flow|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
536695|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536696|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536697|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536698|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536699|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536700|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536701|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536702|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536703|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536746|NCT00216320|O1|Outcome|Subjects Who Used Both WA and AFO|Subjects in arm 1 (wore WalkAide for 6 weeks followed by AFO for 6 weeks) and arm 2 (wore AFO for 6 weeks followed by WalkAide for 6 weeks)were given the option of continuing for 12 more weeks with their choice of device
536747|NCT00216320|E3|Reported Event|Arm 3|All subjects used AFO for all 12 weeks of study.
536704|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536705|NCT00216671|O2|Outcome|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no efficacy data were present.
536706|NCT00216671|O1|Outcome|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days. Two enrolled patients were excluded from the baseline analysis as these patients dropped out early and no safety or efficacy data were present.
536707|NCT00216671|E2|Reported Event|Late Initiation of Treatment|routine practice: The oral AP treatment started during the acute episode will be maintained until week 12. Starting at week 12, 25 mg to 50 mg Risperdal Consta i.m. injection every 14 days. Treatment with previous oral APs will continue 21 days after the first injection and then be tapered off within the next 7 days.
536708|NCT00216671|E1|Reported Event|Early Initiation of Treatment|25 mg to 50 mg Risperdal Consta intramuscular (i.m.) injection every 14 days starting at baseline. Treatment with oral antipsychotics (APs) or risperidone will continue 21 days after the first injection of Risperdal Consta. This treatment will then be tapered off within the next 7 days.
536709|NCT00216476|B3|Baseline|Total|Total of all reporting groups
536710|NCT00216476|B2|Baseline|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
536711|NCT00216476|B1|Baseline|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536712|NCT00216476|P3|Participant Flow|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
536713|NCT00216476|P2|Participant Flow|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
536714|NCT00216476|P1|Participant Flow|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536715|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
536716|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
536717|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536718|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
536719|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
536720|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536721|NCT00216476|O3|Outcome|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
536722|NCT00216476|O2|Outcome|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
536723|NCT00216476|O1|Outcome|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536724|NCT00216476|O1|Outcome|Aripiprazole|oral, recommended maintenance dose of 10-30 mg q.d.
536725|NCT00216476|O2|Outcome|Quetiapine|oral, target dose of 300-400 mg b.i.d. or t.i.d.
536726|NCT00216476|O1|Outcome|Risperidone LAI|intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536727|NCT00216476|E3|Reported Event|Aripiprazole|oral Aripiprazole, recommended maintenance dose of 10-30 mg once daily (q.d.)
536728|NCT00216476|E2|Reported Event|Quetiapine|oral Quetiapine, target dose of 300-400 mg twice daily (b.i.d.) or three times daily (t.i.d.)
536729|NCT00216476|E1|Reported Event|Risperidone LAI|Risperidone Long Acting Injectable (LAI) intramuscular injection, dose of 25, 37.5, or 50 mg every 2 weeks
536730|NCT00216320|B4|Baseline|Total|Total of all reporting groups
536731|NCT00216320|B3|Baseline|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
536732|NCT00216320|B2|Baseline|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
536733|NCT00216320|B1|Baseline|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
536734|NCT00216320|P3|Participant Flow|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
536735|NCT00216320|P2|Participant Flow|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
536736|NCT00216320|P1|Participant Flow|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
536737|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
536738|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
536739|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
536740|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
536741|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
536742|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
536743|NCT00216320|O3|Outcome|Arm 3: No Crossover|Subjects completed the entire 12 weeks period with the AFO, no crossover occurred.
536744|NCT00216320|O2|Outcome|Arm 2: Ankle Foot Orthosis|Subjects started with the AFO and crossed over to the WalkAide after six weeks.
536745|NCT00216320|O1|Outcome|Arm 1: WalkAide|Subjects started with the WalkAide and crossed over to the AFO after six weeks.
536748|NCT00216320|E2|Reported Event|Arm 2|All subjects used AFO for the first 6 weeks and WalkAide for the second six weeks.
536749|NCT00216320|E1|Reported Event|Arm 1|All subjects used WalkAide for the first 6 weeks and AFO for the second six weeks.
536750|NCT00216203|B1|Baseline|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536751|NCT00216203|P1|Participant Flow|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536752|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536753|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536754|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536755|NCT00216203|O1|Outcome|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536756|NCT00216203|O1|Outcome|Investigational Treatment|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536757|NCT00216203|E1|Reported Event|Pemetrexed + Cetuximab|"Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.~Pemetrexed: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles~Cetuximab: Cetuximab 400 mg/m2, week 1, day 1~Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle"
536758|NCT00216125|B1|Baseline|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
536759|NCT00216125|P3|Participant Flow|Observation Only|Patients were followed for Observation.
536760|NCT00216125|P2|Participant Flow|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
536761|NCT00216125|P1|Participant Flow|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)"
536762|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
536763|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
536764|NCT00216125|O2|Outcome|Observation Only|Patients were followed for Observation.
536765|NCT00216125|O1|Outcome|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
536766|NCT00216125|E3|Reported Event|Observation Only|Patients were followed for Observation.
536767|NCT00216125|E2|Reported Event|Consolidation Docetaxel|"Docetaxel 75 mg/m^2 q3wk X 3 cycles.~Docetaxel: docetaxel 75mg/m2 q3wk x 3 cycles"
536768|NCT00216125|E1|Reported Event|Pre-Randomization|"Prior to randomization patients received Cisplatin 50 mg/m^2 days 1,8,29,36 + Etoposide 50 mg/m^2 days 1-5, 29-33 + Radiation 5940 cGy (180 cGy/day). Patients with CR, PR or SD with manageable toxicity were randomized to either Docetaxel arm or Observation only arm.~Cisplatin: Cisplatin 50 mg/m2 day 1, 8, 29, 36~Etoposide: Etoposide 50 mg/m2, days 1-5, 29-33~Radiation: Radiation 5940 cGy (180 cGy/day)~Adverse events reported in this arm consist only of participants that were not randomized into the Consolidation Docetaxel or Observation Only arms."
536769|NCT00216099|B1|Baseline|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536770|NCT00216099|P1|Participant Flow|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536771|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536772|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536773|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536774|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536775|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536776|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536777|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
537027|NCT00214786|B1|Baseline|Islet Cell|Patients with allogeneic islet cell transplantation
536778|NCT00216099|O1|Outcome|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536779|NCT00216099|E1|Reported Event|Pemetrexed 500mg/m^2|"Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle~Pemetrexed: Pemetrexed 500 mg/m2 IV over 10 minutes, day 1 of 21-day cycle"
536780|NCT00216086|B1|Baseline|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536781|NCT00216086|P1|Participant Flow|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536782|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536783|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536784|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536785|NCT00216086|O1|Outcome|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536786|NCT00216086|E1|Reported Event|Single Group Assignment|"Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles *For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Capecitabine: Capecitabine 1000* mg/m2 po bid day 1-14; repeat every three weeks for two cycles~*For calculated creatinine clearance of 30-50 mL/min or patients > 70 years old, capecitabine starting dose is 825 mg/m2 po bid~Irinotecan: Irinotecan 200 mg/m2 IV, day 1~EUS: biopsy per EUS~Neoadjuvant Chemotherapy: Irinotecan 200 mg/m2 IV, day 1 Capecitabine 1000 mg/m2 po bid day 1-14; repeat every three weeks for two cycles~Preoperative Radiation: Pelvic XRT 45 Gy/1.8 GY/fx/qd+5/4 Gy/1.8 Gy/fx/qd for T3+9 Gy/1.8/Gy/fx/qd for T4~Surgery: Surgery within 8 weeks following chemoradiotherapy~Adjuvant Chemotherapy: Adjuvant chemotherapy at investigator's discretion"
536787|NCT00216060|B3|Baseline|Total|Total of all reporting groups
536788|NCT00216060|B2|Baseline|Placebo|daily oral placebo combined with androgen deprivation
536789|NCT00216060|B1|Baseline|Risedronate|Daily oral risedronate combined with androgen deprivation
536790|NCT00216060|P2|Participant Flow|Placebo|daily oral placebo combined with androgen deprivation
536791|NCT00216060|P1|Participant Flow|Risedronate|Daily oral risedronate combined with androgen deprivation
538222|NCT00205049|E2|Reported Event|Placebo|
536792|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536793|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536794|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536795|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536796|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536797|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536798|NCT00216060|O2|Outcome|Placebo|daily oral placebo combined with androgen deprivation
536799|NCT00216060|O1|Outcome|Risedronate|Daily oral risedronate combined with androgen deprivation
536800|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536801|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536802|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536803|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536804|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536805|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536806|NCT00216060|O2|Outcome|Placebo Arm|"daily oral placebo combined with androgen deprivation~Placebo: Daily oral placebo combined with androgen deprivation"
536807|NCT00216060|O1|Outcome|Risedronate Arm|"Daily oral risedronate combined with androgen deprivation~Risedronate: Daily oral risedronate combined with androgen deprivation"
536808|NCT00216060|E2|Reported Event|Risedronate|Daily oral risedronate combined with androgen deprivation
536809|NCT00216060|E1|Reported Event|Placebo|daily oral placebo combined with androgen deprivation
536810|NCT00215943|B3|Baseline|Total|Total of all reporting groups
536811|NCT00215943|B2|Baseline|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536812|NCT00215943|B1|Baseline|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536813|NCT00215943|P2|Participant Flow|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536814|NCT00215943|P1|Participant Flow|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536815|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536816|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536817|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536818|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536819|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536844|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
538223|NCT00205049|E1|Reported Event|Pentoxifylline|
536820|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536821|NCT00215943|O2|Outcome|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536822|NCT00215943|O1|Outcome|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536823|NCT00215943|E2|Reported Event|Active Comparator: Thalidomide and Dexamethasone Treatment|Thalidomide was taken orally once every day in the evening for four to six months. The dexamethasone was taken in a pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4.
536824|NCT00215943|E1|Reported Event|Active Comparator: VAD Treatment|"VAD (vincristine, adriamycin, dexamethasone). Vincristine and adriamycin was administered by continuous infusion via a venous catheter for 96 hours every 28 days. Each 28 days is considered one cycle of therapy. Patients were to receive 4 to 6 cycles of therapy. Dexamethasone was taken in pill form. During the first 2 cycles it was taken on days 1-4, 9-12, 17-20. For all other cycles dexamethasone was taken only on days 1-4. Patients were randomized to receive zoledronic acid IV on either Day 1 or 15 of each cycle."
536825|NCT00215930|B1|Baseline|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
536826|NCT00215930|P1|Participant Flow|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression of Ribonucleotide reductase subunit 1(ERCC1) and Excision repair cross-complementing group 1 gene (RRM1). GD group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and docetaxel (40 mg/m2 on days 1 and 8) every 21 days. DC group was treated with docetaxel (75 mg/m2 on day 1) and carboplatin (AUC 5 on day 1) every 21 days. DV group was treated with vinorelbine (45mg/m2ondays 1 and 15) and docetaxel (60mg/m2ondays 1 and 15) every 28 days. GC group was treated with gemcitabine (1,250 mg/m2 on days 1 and 8) and carboplatin (area under the concentration-time curve [AUC] of 5 on day 1) every 21 days.
536827|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
536828|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
536829|NCT00215930|O1|Outcome|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression. Complete Response (CR): disappearance of all target lesions. Partial Response (PR): at least a 30% decrease in the sum of longest diameter (LD) of target lesions taking as reference the baseline sum LD. Progressive Disease (PD): at least a 20% increase in the sum of LD of target lesions taking as references the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions. Stable Disease (SD): neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD taking as references the smallest sum LD since the treatment started.
536830|NCT00215930|E1|Reported Event|Double Agent Chemotherapy|Molecular Analysis-Directed Chemotherapy Assignment based on gene expression.
536831|NCT00215787|B1|Baseline|Lansoprazole|Lansoprazole 30mg BID for one year
536832|NCT00215787|P1|Participant Flow|Lansoprazole|Lansoprazole 30mg BID for one year
536833|NCT00215787|O1|Outcome|Lansoprazole|Lansoprazole 30mg BID for one year
536834|NCT00215787|E1|Reported Event|Lansoprazole|Lansoprazole 30mg BID for one year
536835|NCT00215683|B4|Baseline|Total|Total of all reporting groups
536836|NCT00215683|B3|Baseline|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536837|NCT00215683|B2|Baseline|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536838|NCT00215683|B1|Baseline|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536839|NCT00215683|P3|Participant Flow|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536840|NCT00215683|P2|Participant Flow|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536841|NCT00215683|P1|Participant Flow|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536842|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536843|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536898|NCT00215553|B2|Baseline|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536845|NCT00215683|O3|Outcome|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536846|NCT00215683|O2|Outcome|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536847|NCT00215683|O1|Outcome|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536848|NCT00215683|E3|Reported Event|Degarelix 160 mg|Participants who completed the CS12 study in the Degarelix 160 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536849|NCT00215683|E2|Reported Event|Degarelix 120 mg|Participants who completed the CS12 study in the Degarelix 120 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536850|NCT00215683|E1|Reported Event|Degarelix 80 mg|Participants who completed the CS12 study in the Degarelix 80 mg arm continued that dose into the CS12A extension study. A protocol amendment in January 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
536851|NCT00215657|B9|Baseline|Total|Total of all reporting groups
536852|NCT00215657|B8|Baseline|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
536853|NCT00215657|B7|Baseline|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
536854|NCT00215657|B6|Baseline|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
536855|NCT00215657|B5|Baseline|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
536856|NCT00215657|B4|Baseline|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
536857|NCT00215657|B3|Baseline|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
536858|NCT00215657|B2|Baseline|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
536859|NCT00215657|B1|Baseline|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
536860|NCT00215657|P8|Participant Flow|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
536861|NCT00215657|P7|Participant Flow|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
536862|NCT00215657|P6|Participant Flow|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
536863|NCT00215657|P5|Participant Flow|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
536864|NCT00215657|P4|Participant Flow|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
536865|NCT00215657|P3|Participant Flow|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
536866|NCT00215657|P2|Participant Flow|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
536867|NCT00215657|P1|Participant Flow|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
536868|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
536869|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
536870|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
536871|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
536872|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
536873|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
536874|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
536875|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
536876|NCT00215657|O8|Outcome|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
536877|NCT00215657|O7|Outcome|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
536878|NCT00215657|O6|Outcome|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
536879|NCT00215657|O5|Outcome|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
536880|NCT00215657|O4|Outcome|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
536881|NCT00215657|O3|Outcome|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
536882|NCT00215657|O2|Outcome|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
536883|NCT00215657|O1|Outcome|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
536884|NCT00215657|E8|Reported Event|Degarelix 320mg (60mg/mL)|Degarelix 320 mg (60 mg/mL)
536885|NCT00215657|E7|Reported Event|Degarelix 240mg (60mg/mL)|Degarelix 240 mg (60 mg/mL)
536886|NCT00215657|E6|Reported Event|Degarelix 240mg (40mg/mL)|Degarelix 240 mg (40 mg/mL)
536887|NCT00215657|E5|Reported Event|Degarelix 200mg (60mg/mL)|Degarelix 200 mg (60 mg/mL)
536888|NCT00215657|E4|Reported Event|Degarelix 200mg (40mg/mL)|Degarelix 200 mg (40 mg/mL)
536889|NCT00215657|E3|Reported Event|Degarelix 160mg (40mg/mL)|Degarelix 160 mg (40 mg/mL)
536890|NCT00215657|E2|Reported Event|Degarelix 120mg (40mg/mL)|Degarelix 120 mg (40 mg/mL)
536891|NCT00215657|E1|Reported Event|Degarelix 120mg (20mg/mL)|Degarelix 120 mg (20 mg/mL)
536892|NCT00215553|B8|Baseline|Total|Total of all reporting groups
536893|NCT00215553|B7|Baseline|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
536894|NCT00215553|B6|Baseline|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536895|NCT00215553|B5|Baseline|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536896|NCT00215553|B4|Baseline|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536897|NCT00215553|B3|Baseline|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536899|NCT00215553|B1|Baseline|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536900|NCT00215553|P7|Participant Flow|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
536901|NCT00215553|P6|Participant Flow|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536902|NCT00215553|P5|Participant Flow|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536903|NCT00215553|P4|Participant Flow|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536904|NCT00215553|P3|Participant Flow|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536905|NCT00215553|P2|Participant Flow|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536906|NCT00215553|P1|Participant Flow|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536907|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
536908|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536909|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536910|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536911|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536912|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536913|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536914|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
536915|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536916|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536917|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536918|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536919|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536920|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536921|NCT00215553|O7|Outcome|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
536922|NCT00215553|O6|Outcome|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536923|NCT00215553|O5|Outcome|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536924|NCT00215553|O4|Outcome|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536925|NCT00215553|O3|Outcome|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536926|NCT00215553|O2|Outcome|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536927|NCT00215553|O1|Outcome|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536928|NCT00215553|E7|Reported Event|B.3 SoC|Received standard ARDS management and ICU care. Included, but was not limited to, support with oxygen, conventional mechanical ventilation, sedations, and paralysis.
537024|NCT00214903|E3|Reported Event|ooHRT|Users of oral but not continuous combined HRT preparations
537025|NCT00214903|E2|Reported Event|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
536929|NCT00215553|E6|Reported Event|B.2 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536930|NCT00215553|E5|Reported Event|B.1 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536931|NCT00215553|E4|Reported Event|A.4 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids (TPL). One re-treatment at 48 hours. One bolus re-treatment (20 mg/mL TPL) in another 48 hours. A second bolus re-treatment (20 mg/mL TPL) administered 48 hours later.
536932|NCT00215553|E3|Reported Event|A.3 Lucinactant|2 50-mL aliquots per bronchopulmonary segment using concentrations of 10 and 20 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536933|NCT00215553|E2|Reported Event|A.2 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 10, 10, and 10 mg/mL total phospholipids. One lavage re-treatment at 48 hours.
536934|NCT00215553|E1|Reported Event|A.1 Lucinactant|3 30-mL aliquots per bronchopulmonary segment using concentrations of 5, 5, and 10 mg/mL total phopholipids. One re-treatment at 48 hours.
536935|NCT00215540|B4|Baseline|Total|Total of all reporting groups
536936|NCT00215540|B3|Baseline|Placebo|Sham air using 3.0 mL/kg volume of air
536937|NCT00215540|B2|Baseline|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536938|NCT00215540|B1|Baseline|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536939|NCT00215540|P3|Participant Flow|Placebo|Sham air using 3.0 mL/kg volume of air
536940|NCT00215540|P2|Participant Flow|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536941|NCT00215540|P1|Participant Flow|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536942|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536943|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536944|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536945|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536946|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536947|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536948|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536949|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536950|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536951|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536952|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536953|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536954|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536955|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536956|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536957|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536958|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536959|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536960|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536961|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536962|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536963|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536964|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536965|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536966|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536967|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536968|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536969|NCT00215540|O3|Outcome|Placebo|Sham air using 3.0 mL/kg volume of air
536970|NCT00215540|O2|Outcome|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536971|NCT00215540|O1|Outcome|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536972|NCT00215540|E3|Reported Event|Placebo|Sham air using 3.0 mL/kg volume of air
536973|NCT00215540|E2|Reported Event|SURFAXIN Low Dose|SURFAXIN (lucinactant) at 90 mg/kg
536974|NCT00215540|E1|Reported Event|SURFAXIN High Dose|SURFAXIN (lucinactant) at 175 mg/kg
536975|NCT00215150|B1|Baseline|Study Treatment|8 weeks of open label treatment with sertraline followed by 8 weeks of treatment with ziprasidone/placebo for qualifying subjects
536976|NCT00215150|P1|Participant Flow|Open Label Treatment|8 weeks of open label treatment with sertraline (50-200mg/day)followed by 8 weeks of randomized, Double Blind (DB), placebo-controlled augmentation with ziprasidone (40-160mg/day)for qualifying subjects.
536977|NCT00215150|O3|Outcome|Randomization Phase for Placebo Group|The group of subjects randomized to receive placebo for the second 8 weeks
536978|NCT00215150|O2|Outcome|Randomization Phase for Ziprasidone Group|The group of subjects randomized to receive Ziprasidone for the second 8 weeks
536979|NCT00215150|O1|Outcome|Open Label Phase|The open label treatment phase for the first 8 weeks
536980|NCT00215150|E3|Reported Event|Randomization Phase for Placebo|The second phase of treatment with subjects randomized to placebo augmentation.
536981|NCT00215150|E2|Reported Event|Randomization Phase for Ziprasidone|The second phase of treatment with subjects randomized to ziprasidone augmentation.
536982|NCT00215150|E1|Reported Event|Open Label Phase|The first 8 weeks of treatment on sertraline
536983|NCT00215137|B1|Baseline|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
537026|NCT00214903|E1|Reported Event|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
538224|NCT00204932|B3|Baseline|Total|Total of all reporting groups
536984|NCT00215137|P3|Participant Flow|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
536985|NCT00215137|P2|Participant Flow|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
536986|NCT00215137|P1|Participant Flow|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
536987|NCT00215137|O3|Outcome|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from beginning of the study phase sample.
536988|NCT00215137|O2|Outcome|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post beginning of the study phase sample.
536989|NCT00215137|O1|Outcome|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.Data presented is based on an intent to treat (ITT), last observation carried forward (LOCF) from post baseline sample.
536990|NCT00215137|E3|Reported Event|Randomization Escitalopram|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
536991|NCT00215137|E2|Reported Event|Randomization Placebo|Of the thirteen patients who completed the open label part of the trial, twelve demonstrated at least minimal improvement (CGI-I < 3) and agreed to continue with the randomized, double-blind phase. These patients were randomized to escitalopram (n=5) or placebo (n=7).
536992|NCT00215137|E1|Reported Event|Open Label Escitalopram|Fourteen patients who met criteria for the study were enrolled in the open-label phase. Thirteen of these patients completed the open-label phase, while one patient was terminated early due to side effects.
536993|NCT00214201|B3|Baseline|Total|Total of all reporting groups
536994|NCT00214201|B2|Baseline|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
536995|NCT00214201|B1|Baseline|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
536996|NCT00214201|P2|Participant Flow|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
536997|NCT00214201|P1|Participant Flow|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
536998|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
536999|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
537000|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
537001|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of care CNI Immunosuppression
537002|NCT00214201|O2|Outcome|CNI Withdrawal Post Campath 1H|Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy
537003|NCT00214201|O1|Outcome|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
537004|NCT00214201|E2|Reported Event|CNI Withdrawal Post Campath 1H|"Calcineurin inhibitor withdrawal~Calcineurin inhibitor withdrawal : stopping tacrolimus or cyclosporine in subjects who received Campath-1H induction therapy"
537005|NCT00214201|E1|Reported Event|CNI Control Post Campath 1H|Standard of Care CNI immunosuppression
537006|NCT00214903|B5|Baseline|Total|Total of all reporting groups
537007|NCT00214903|B4|Baseline|Non-oral HRT|Users of non-oral HRT preparations
537008|NCT00214903|B3|Baseline|ooHRT|Users of oral but not continuous combined HRT preparations
537009|NCT00214903|B2|Baseline|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
537010|NCT00214903|B1|Baseline|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
537011|NCT00214903|P4|Participant Flow|Non-oral HRT|Users of non-oral HRT preparations
537012|NCT00214903|P3|Participant Flow|ooHRT|Users of oral but not continuous combined HRT preparations
537013|NCT00214903|P2|Participant Flow|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
537014|NCT00214903|P1|Participant Flow|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
537015|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
537016|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
537017|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
537018|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
537019|NCT00214903|O4|Outcome|Non-oral HRT|Users of non-oral HRT preparations
537020|NCT00214903|O3|Outcome|ooHRT|Users of oral but not continuous combined HRT preparations
537021|NCT00214903|O2|Outcome|ooccHRT|Users of other oral continuous combined HRT preparations containing other progestogens
537022|NCT00214903|O1|Outcome|DRSP/E2|Users of oral continuous combined preparations containing 2mg DRSP and 1mg estradiol
537023|NCT00214903|E4|Reported Event|Non-oral HRT|Users of non-oral HRT preparations
537028|NCT00214786|P1|Participant Flow|Islet Cell Transplantation|Patients who received islet cell transplantation. The recipients will be given islet cell preparation with more than 4000 Islet Equivalent (IE)/kg for multiple times up to 3 infusions.
537029|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537030|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537031|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537032|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537033|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537034|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537035|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537036|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537037|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537038|NCT00214786|O1|Outcome|Islet Cell|Allogeneic Islet Cell Transplantation
537039|NCT00214786|E1|Reported Event|Islet Cell|Patients with allogeneic islet cell transplantation
537040|NCT00214539|B3|Baseline|Total|Total of all reporting groups
537041|NCT00214539|B2|Baseline|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537042|NCT00214539|B1|Baseline|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537043|NCT00214539|P2|Participant Flow|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537044|NCT00214539|P1|Participant Flow|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537045|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537046|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537047|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537048|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537049|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537050|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537051|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537052|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537053|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537054|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537055|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537056|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537057|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537058|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537059|NCT00214539|O2|Outcome|Control|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day).
537060|NCT00214539|O1|Outcome|Alair|Standard-of-care therapy of high dose inhaled corticosteroids (ICS) + long acting beta agonists (LABA) ± oral corticosteroids (OCS) (≤ 30 mg/day) plus treatment with the Alair System.
537061|NCT00214539|E6|Reported Event|Control (Steroid Wean and Reduced Steroid Phases)|
537062|NCT00214539|E5|Reported Event|Alair (Steroid Wean and Reduced Steroid Phases)|
537063|NCT00214539|E4|Reported Event|Control (Steroid Stable Phase)|
537064|NCT00214539|E3|Reported Event|Alair (Steroid Stable Phase)|
537065|NCT00214539|E2|Reported Event|Control (Treatment Period)|
537066|NCT00214539|E1|Reported Event|Alair (Treatment Period)|
537067|NCT00214526|B3|Baseline|Total|Total of all reporting groups
537068|NCT00214526|B2|Baseline|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537069|NCT00214526|B1|Baseline|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537070|NCT00214526|P2|Participant Flow|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537868|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537071|NCT00214526|P1|Participant Flow|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537072|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537073|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537074|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537075|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537076|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537077|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537078|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537079|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537080|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537081|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537082|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537083|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537084|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537085|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537086|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537087|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537088|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537089|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537090|NCT00214526|O2|Outcome|Control Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA). Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537091|NCT00214526|O1|Outcome|Alair Group|Conventional therapy with inhaled corticosteroids and long-acting beta-agonists (ICS+LABA) plus bronchial thermoplasty with the Alair System. Throughout the Treatment Period subjects maintained their baseline daily asthma maintenance medications regimen.
537092|NCT00214526|E4|Reported Event|Control (Post-Treatment Period)|From 6 weeks after last Control visit through 1 year.
537093|NCT00214526|E3|Reported Event|Alair (Post-Treatment Period)|From 6 weeks after last Treatment visit through 1 year.
537094|NCT00214526|E2|Reported Event|Control (Treatment Period)|From first Control visit through 6 weeks after last Control visit.
537095|NCT00214526|E1|Reported Event|Alair (Treatment Period)|From first Treatment visit through 6 weeks after last Treatment visit.
537096|NCT00214487|B3|Baseline|Total|Total of all reporting groups
537097|NCT00214487|B2|Baseline|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
537098|NCT00214487|B1|Baseline|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
537099|NCT00214487|P2|Participant Flow|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
537100|NCT00214487|P1|Participant Flow|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
537101|NCT00214487|O2|Outcome|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
537102|NCT00214487|O1|Outcome|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
537103|NCT00214487|E2|Reported Event|Control|"Single vision soft contact lenses~Placebo Control: Single vision soft contact lenses"
537104|NCT00214487|E1|Reported Event|Bifocal Contact Lenses|"Use of bifocal contact lenses to control the progression of myopia~Bifocal Contact Lenses: Use of bifocal contact lenses of varying add powers to control the progression of myopia"
537105|NCT00214461|B5|Baseline|Total|Total of all reporting groups
537106|NCT00214461|B4|Baseline|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
537107|NCT00214461|B3|Baseline|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537108|NCT00214461|B2|Baseline|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537109|NCT00214461|B1|Baseline|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
537110|NCT00214461|P4|Participant Flow|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
537111|NCT00214461|P3|Participant Flow|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537112|NCT00214461|P2|Participant Flow|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537113|NCT00214461|P1|Participant Flow|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
537114|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
537115|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537116|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537117|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
537118|NCT00214461|O4|Outcome|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
537119|NCT00214461|O3|Outcome|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537120|NCT00214461|O2|Outcome|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537121|NCT00214461|O1|Outcome|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
537122|NCT00214461|E4|Reported Event|High-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 50 µg, C. difficile vaccine on Days 0, 28, and 56, respectively.
537123|NCT00214461|E3|Reported Event|Medium-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 10 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537124|NCT00214461|E2|Reported Event|Low-dose C. Difficile Vaccine Group|Participants who received a dose of vaccine containing 2 µg C. difficile toxoid on Days 0, 28, and 56, respectively.
537125|NCT00214461|E1|Reported Event|Placebo Vaccine Group|Participants who received a dose of placebo, on Days 0, 28, and 56, respectively.
537126|NCT00214383|B3|Baseline|Total|Total of all reporting groups
537127|NCT00214383|B2|Baseline|Control|Control-usual care
537128|NCT00214383|B1|Baseline|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537129|NCT00214383|P2|Participant Flow|Control|Control-usual care
537130|NCT00214383|P1|Participant Flow|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537131|NCT00214383|O2|Outcome|Control|Control-usual care
537132|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537133|NCT00214383|O2|Outcome|Control|Control-usual care
537134|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537135|NCT00214383|O2|Outcome|Control|Control-usual care
537136|NCT00214383|O1|Outcome|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537137|NCT00214383|E2|Reported Event|Control|Control-usual care
537138|NCT00214383|E1|Reported Event|CHESS + Case Mgt|Case Management (with monthly support calls) and CHESS services were available for a 12 month intervention period.
537139|NCT00214019|B1|Baseline|4 Way Cross Over|"Participants completed all 4 arms:~Placebo Salmeterol diskus 40 mcg twice per day Placebo then fluticasone Salmeterol then Fluticasone"
537140|NCT00214019|P1|Participant Flow|Placebo/Placebo|Placebo Diskus/Placebo Diskus 28 days
537141|NCT00214019|O4|Outcome|Salmeterol/Fluticasone|Participants on Salmeterol/Fluticasone
537142|NCT00214019|O3|Outcome|Placebo/fFuticasone|Participants on Placebo/Fluticasone arm
537143|NCT00214019|O2|Outcome|Placebo/Salmeterol|Participants on Placebo/Salmeterol arm
537144|NCT00214019|O1|Outcome|Placebo/Placebo|Participants on Placebo/Placebo arm
537145|NCT00214019|E1|Reported Event|4 Way Cross Over|"Participants completed all 4 treatments:~Placebo Salmeterol diskus 50 mcg twice per day Placebo then Fluticasone Salmeterol then Fluticasone"
537146|NCT00213135|B4|Baseline|Total|Total of all reporting groups
537239|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537147|NCT00213135|B3|Baseline|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537148|NCT00213135|B2|Baseline|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537149|NCT00213135|B1|Baseline|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537150|NCT00213135|P3|Participant Flow|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537151|NCT00213135|P2|Participant Flow|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537152|NCT00213135|P1|Participant Flow|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537153|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537154|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537155|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537156|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537157|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537158|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537159|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537160|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537161|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537162|NCT00213135|O3|Outcome|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537163|NCT00213135|O2|Outcome|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537164|NCT00213135|O1|Outcome|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537165|NCT00213135|E3|Reported Event|Placebo|Placebo matched to cladribine tablet administered over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48 and 52 during the treatment period of 96 weeks.
537166|NCT00213135|E2|Reported Event|Cladribine 3.5 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 mg/kg over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 48, and 52 and placebo matched to cladribine tablet was administered at Week 9 and 13 resulting in total cladribine dose of 3.5 mg/kg during the treatment period of 96 weeks.
537167|NCT00213135|E1|Reported Event|Cladribine 5.25 mg/kg|Cladribine tablet administered as cumulative dose of 0.875 milligram per kilogram (mg/kg) over a course of 4 or 5 consecutive days of 28-day period at Week 1, 5, 9, 13, 48, and 52 resulting in total cladribine dose of 5.25 mg/kg during the treatment period of 96 weeks.
537168|NCT00211536|B3|Baseline|Total|Total of all reporting groups
537169|NCT00211536|B2|Baseline|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537869|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537170|NCT00211536|B1|Baseline|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537171|NCT00211536|P2|Participant Flow|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537172|NCT00211536|P1|Participant Flow|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537173|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537174|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537175|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537176|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537177|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537204|NCT00212758|B1|Baseline|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
537240|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537178|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537179|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537180|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537181|NCT00211536|O2|Outcome|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537182|NCT00211536|O1|Outcome|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~The primary efficacy analysis set will include all subjects randomized and followed, at least, to Visit 5 (90 days, first insulin refill for MIP group). Missing data are treated as missing. There is no extrapolation or interpolation of missing values. This set is considered to be the As-Treated Data Analysis Set and is the primary data set used in the analysis."
537183|NCT00211536|E2|Reported Event|Subcutaneous Insulin Arm (SC)|"The control group will remain on their pre-study subcutaneous insulin therapy either Multiple Daily Injections (MDI) or Continuous Subcutaneous Insulin Infusion (CSII - external insulin pump). The SC group will not be restricted to the type of insulin used.~For consistency, results were analyzed for subjects that completed beyond V5. These were considered to be the As Treated group. All randomized subjects were assessed for safety risk."
537184|NCT00211536|E1|Reported Event|MiniMed Implantable Insulin Pump (MIP)|"The experimental group will receive intraperitoneally (IP) delivered insulin via the Medtronic MiniMed Implantable Pump (MIP). At the time of implant, the pump will be filled with Aventis HOE21PH U400 insulin and the subject will be treated with this insulin for the first 180 days post implant. During the refill procedure performed 180 days post implant, any insulin remaining in the pump will be removed and the pump will be refilled with Medtronic MiniMed Implantable Pump Human Recombinant Insulin.~Results were analyzed for subjects that completed beyond V5, which was the end of the first 90 day period of IP insulin therapy. These were considered to be the As Treated group.~All randomized subjects were assessed for safety risk."
537185|NCT00211510|B3|Baseline|Total|Total of all reporting groups
537186|NCT00211510|B2|Baseline|Paradigm 715 Insulin Pump|
537187|NCT00211510|B1|Baseline|Paradigm 722 Sensor Augmented Pump|
537188|NCT00211510|P2|Participant Flow|Paradigm 715 Insulin Pump|
537189|NCT00211510|P1|Participant Flow|Paradigm 722 Sensor Augmented Pump|
537190|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537191|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537192|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537193|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537194|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537195|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537196|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537197|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537198|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537199|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537200|NCT00211510|O2|Outcome|Paradigm 715 Insulin Pump|
537201|NCT00211510|O1|Outcome|Paradigm 722 Sensor Augmented Pump|
537202|NCT00211510|E2|Reported Event|Paradigm 715 Insulin Pump|
537203|NCT00211510|E1|Reported Event|Paradigm 722 Sensor Augmented Pump|
537205|NCT00212758|P2|Participant Flow|Standard- Low- Standard GH|This group was randomized to receive 0.05 mg/kg/day of growth hormone for 7 doses given subcutaneously followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the low dose of 0.025 mg/kg/day for 7 days.
537293|NCT00211172|B3|Baseline|Total|Total of all reporting groups
537206|NCT00212758|P1|Participant Flow|Low-standard-standard GH|This group was randomized to receive 0.025 mg/kg/day of growth hormone for 7 doses given subcutaneously, followed by 2 weeks of wash out and then another 7 days of GH therapy (Nutropin AQ) at the standard dose of 0.05 mg/kg/day for 7 days.
537207|NCT00212758|O1|Outcome|All Participants|Subjects will be randomized to either a low or standard arm. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months, re-evaluate growth velocity and then continue for another 6 months on GH.
537208|NCT00212758|O2|Outcome|Standard Dose GH|Subjects will be randomized to either a low or standard arm. The Standard dose GH group will get 0.05 mg/kg/day of growth hormone therapy for 7 days followed by 2 week wash out and then another 7 days of GH therapy on the low dose of 0.025 mg/kg/dose given subcutaneously.
537209|NCT00212758|O1|Outcome|Low Dose GH|Subjects will be randomized to either a low or standard arm. The low dose GH group will get 0.025 mg/kg/day of growth hormone therapy for 7 days followed by 2 weeks of wash out and then another 7 days of GH therapy on the standard dose of 0.05 mg/kg/dose given subcutaneously.
537210|NCT00212758|E1|Reported Event|All Participants|There will be 2 arms in the study who will be randomized in a cross over design. The low dose will get 0.025 mg/kg/day of growth hormone therapy and the standard dose arm will receive 0.05 mg/kg/dose given subcutaneously. After one week of therapy and 2 weeks of wash out, subjects will change the dose of GH therapy and will receive the alternate dose for another week. After that all subjects will be treated with the standard dose of GH therapy of 0.05 mg/kg/day for 6 months.
537211|NCT00212355|B1|Baseline|NPC-02|"zinc acetate~NPC-02: zinc acetate"
537212|NCT00212355|P1|Participant Flow|NPC-02|"zinc acetate~NPC-02: zinc acetate"
537213|NCT00212355|O1|Outcome|NPC-02|"zinc acetate~NPC-02: zinc acetate"
537214|NCT00212355|E1|Reported Event|NPC-02|"zinc acetate~NPC-02: zinc acetate"
537215|NCT00212264|B4|Baseline|Total|Total of all reporting groups
537216|NCT00212264|B3|Baseline|Placebo Comparator|No treatment control
537217|NCT00212264|B2|Baseline|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
537218|NCT00212264|B1|Baseline|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
537219|NCT00212264|P3|Participant Flow|Placebo Comparator|No treatment control
537220|NCT00212264|P2|Participant Flow|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
537221|NCT00212264|P1|Participant Flow|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
537222|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
537223|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
537224|NCT00212264|O3|Outcome|Placebo Comparator|No treatment control
537225|NCT00212264|O2|Outcome|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
537226|NCT00212264|O1|Outcome|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
537227|NCT00212264|E3|Reported Event|Placebo Comparator|No treatment control
537228|NCT00212264|E2|Reported Event|Behavioral Therapy Plus Technologies|"Behavioral therapy plus technologies (home pelvic floor electrical stimulation and biofeedback)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies~Pelvic Floor Electrical Stimulation: Pelvic Floor Electrical Stimulation daily for 8 weeks~Biofeedback: Pelvic Floor Muscle training via biofeedback"
537229|NCT00212264|E1|Reported Event|Behavioral Therapy|"Behavioral Therapy (Pelvic floor muscle training, bladder control strategies)~Behavioral Therapy: Pelvic Floor Muscle Exercises and Bladder control strategies"
537230|NCT00212134|B3|Baseline|Total|Total of all reporting groups
537231|NCT00212134|B2|Baseline|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537232|NCT00212134|B1|Baseline|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537233|NCT00212134|P2|Participant Flow|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537234|NCT00212134|P1|Participant Flow|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537235|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537236|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537237|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537238|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537241|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537242|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537243|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537244|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537245|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: At the time of surgery to remove the cataractous natural lens, an intraocular lens was implanted to correct the large hyperopic refractive error induced by the cataract surgery.~primary implantation of aphakic intraocular lens: optical correction of surgical aphakia with intraocular lens"
537246|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly.~hyperopic correction of infant surgical aphakia with Contact Lens: optical correction of infant surgical aphakia with Contact lens"
537247|NCT00212134|O2|Outcome|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: The refractive error induced by surgical removal of the cataractous natural lens is partially corrected by the implantation of an intraocular lens (IOL) at the time of surgery. This is deemed a permanent correction as the IOL may only be removed in a subsequent surgery."
537248|NCT00212134|O1|Outcome|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: use of an external contact lens (CL) to correct the large hyperopic refractive error produced by surgically extracting the natural cataractous lens. As the eye grows, the refractive error changes and the power of the CL can be changed accordingly."
537249|NCT00212134|E2|Reported Event|Aphakic Intraocular Lens|"optical correction of infant aphakia with aphakic Intraocular Lens~INTERVENTION: aphakic intraocular lens"
537250|NCT00212134|E1|Reported Event|Aphakic Contact Lens|"optical correction of infant aphakia with aphakic Contact lens~INTERVENTION: aphakic contact lens"
537251|NCT00211887|B4|Baseline|Total|Total of all reporting groups
537252|NCT00211887|B3|Baseline|Glatiramer|glatiramer acetate
537253|NCT00211887|B2|Baseline|IFB-1a|Interferon beta-1a
537254|NCT00211887|B1|Baseline|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537255|NCT00211887|P3|Participant Flow|Glatiramer Acetate|glatiramer acetate 20mg daily
537256|NCT00211887|P2|Participant Flow|Interferon Beta 1a|Interferon beta-1a 30µg intramuscularly weekly
537257|NCT00211887|P1|Participant Flow|IFN + GA|Interferon beta-1a 30µg intramuscularly weekly and glatiramer acetate (GA) 20mg daily
537258|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
537259|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
537260|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537261|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
537262|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
537263|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537264|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
537265|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
537266|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537267|NCT00211887|O3|Outcome|Glatiramer|glatiramer acetate
537268|NCT00211887|O2|Outcome|IFB-1a|Interferon beta-1a
537269|NCT00211887|O1|Outcome|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537270|NCT00211887|E3|Reported Event|Glatiramer|glatiramer acetate
537271|NCT00211887|E2|Reported Event|IFB-1a|Interferon beta-1a
537272|NCT00211887|E1|Reported Event|IFN + GA|Interferon beta-1a intramuscularly weekly and glatiramer acetate daily
537273|NCT00211692|B3|Baseline|Total|Total of all reporting groups
537274|NCT00211692|B2|Baseline|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
537275|NCT00211692|B1|Baseline|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
537276|NCT00211692|P2|Participant Flow|Group B Duration Based on Viral Response|CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given for 52-72 weeks (from time of viral response +48 weeks) (group B)
537277|NCT00211692|P1|Participant Flow|Group A 52 Weeks Treatment|Daily CIFN (15 mcg/day SQ) and RBV (1-1.2 g/d PO) given 52 weeks (group A)
537278|NCT00211692|O1|Outcome|Overall|
537279|NCT00211692|O1|Outcome|Overall|
537280|NCT00211692|O1|Outcome|Overall|
537281|NCT00211692|O2|Outcome|B (Duration Based on Viral Response)|
537282|NCT00211692|O1|Outcome|A (52 Weeks Treatment)|
537283|NCT00211692|E1|Reported Event|Overall|
537284|NCT00211237|B3|Baseline|Total|Total of all reporting groups
537285|NCT00211237|B2|Baseline|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
537286|NCT00211237|B1|Baseline|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
537287|NCT00211237|P2|Participant Flow|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
537288|NCT00211237|P1|Participant Flow|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
537289|NCT00211237|O2|Outcome|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
537290|NCT00211237|O1|Outcome|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
537291|NCT00211237|E2|Reported Event|Non Surgical Management|Non-surgical treatment aimed at alleviation of back pain and restoration of decreased function associated with VCF(s).
537292|NCT00211237|E1|Reported Event|Balloon Kyphoplasty|Randomized, Unblinded Controlled Study
537294|NCT00211172|B2|Baseline|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
537295|NCT00211172|B1|Baseline|Usual Care|Usual care patients were not contacted by the study.
537296|NCT00211172|P2|Participant Flow|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
537297|NCT00211172|P1|Participant Flow|Usual Care|Usual care patients were not contacted by the study.
537298|NCT00211172|O2|Outcome|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
537299|NCT00211172|O1|Outcome|Usual Care|Usual care patients were not contacted by the study.
537300|NCT00211172|E2|Reported Event|Reminder Mailing|The intervention consisted of 2 mailed communications. A personalized letter was mailed first, followed approximately 2 months later by a similar letter and an accompanying brochure. Both mailings also included a wallet card that suggested questions for the patient to ask their clinician, space to list their medications, and space to record additional queries. The communications contained nearly identical information, stressing the importance of lifetime use of beta-blockers following acute myocardial infarction (AMI) and that adverse effects can be managed and the importance of remembering to refill their prescription. They also included a brief mention of other therapies (statins, ACE inhibitors [ACEIs], and aspirin).
537301|NCT00211172|E1|Reported Event|Usual Care|Usual care patients were not contacted by the study.
537302|NCT00211081|B1|Baseline|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
537303|NCT00211081|P1|Participant Flow|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
537304|NCT00211081|O1|Outcome|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
537305|NCT00211081|E1|Reported Event|Spironolactone|Subjects took spironolactone at 25 mg daily. After two weeks, Spironolactone was doubled to 50 mg daily for remaining 2 weeks.
537306|NCT00210639|B3|Baseline|Total|Total of all reporting groups
537307|NCT00210639|B2|Baseline|Comparator|Participants who received comparator in the previous studies.
537308|NCT00210639|B1|Baseline|Levofloxacin|Participants who received levofloxacin in the previous studies.
537309|NCT00210639|P2|Participant Flow|Comparator|Participants who received comparator in the previous studies.
537310|NCT00210639|P1|Participant Flow|Levofloxacin|Participants who received levofloxacin in the previous studies.
537311|NCT00210639|O2|Outcome|Comparator|Participants who received comparator in the previous studies.
537312|NCT00210639|O1|Outcome|Levofloxacin|Participants who received levofloxacin in the previous studies.
537313|NCT00210639|E2|Reported Event|Comparator|Participants who received comparator in the previous studies.
537314|NCT00210639|E1|Reported Event|Levofloxacin|Participants who received levofloxacin in the previous studies.
537315|NCT00210626|B3|Baseline|Total|Total of all reporting groups
537316|NCT00210626|B2|Baseline|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
537317|NCT00210626|B1|Baseline|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
537318|NCT00210626|P2|Participant Flow|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
537319|NCT00210626|P1|Participant Flow|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
537320|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
537321|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
537322|NCT00210626|O2|Outcome|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
537323|NCT00210626|O1|Outcome|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
537324|NCT00210626|E2|Reported Event|Placebo|Placebo given at equivalent volume (1 mL) as Procrit
537325|NCT00210626|E1|Reported Event|PROCRIT|40,000 IU/mL/week for maximum of 12 weeks
537326|NCT00210470|B1|Baseline|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
537327|NCT00210470|P1|Participant Flow|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
537328|NCT00210470|O1|Outcome|IRX-2 Regimen|A 2-week course of IRX-2, an initial low dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation
537329|NCT00210470|E1|Reported Event|IRX-2 Regimen|The IRX-2 regimen is the combination of a 2-week course of IRX-2 itself, an initial dose of cyclophosphamide, and a 3-week course of indomethacin and zinc supplementation.
537330|NCT00209560|B3|Baseline|Total|Total of all reporting groups
537331|NCT00209560|B2|Baseline|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
537332|NCT00209560|B1|Baseline|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
537333|NCT00209560|P2|Participant Flow|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
537334|NCT00209560|P1|Participant Flow|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
537335|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
537336|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
537337|NCT00209560|O2|Outcome|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
537338|NCT00209560|O1|Outcome|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
537339|NCT00209560|E2|Reported Event|Midazolam|0.5 to 2 mg (dose based on weight and age): one initial i.v. bolus dose. Supplemental doses of midazolam 0.25 mg to 1 mg (based on weight and age) were administered as needed.
537340|NCT00209560|E1|Reported Event|Fospropofol Disodium|525 mg to 980 mg (dose based on weight and age): one initial intravenous (i.v.) bolus dose. Supplemental doses of fospropofol disodium 105 mg to 140 mg (based on weight and age) were administered as needed.
537341|NCT00209417|B3|Baseline|Total|Total of all reporting groups
537342|NCT00209417|B2|Baseline|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
537343|NCT00209417|B1|Baseline|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
537344|NCT00209417|P2|Participant Flow|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
537345|NCT00209417|P1|Participant Flow|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
537346|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
537347|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
537348|NCT00209417|O2|Outcome|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
537349|NCT00209417|O1|Outcome|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
537350|NCT00209417|E2|Reported Event|Iopamidol 300-Arm 2|"Iopamidol 300 mg I/mL~Iopamidol 300-Arm 2"
537351|NCT00209417|E1|Reported Event|Iodixanol 320-Arm 1|"Iodixanol 320 mg I/mL~Iodixanol 320-Arm 1"
537352|NCT00209339|B1|Baseline|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537353|NCT00209339|P1|Participant Flow|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537354|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537355|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537356|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537357|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537358|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537359|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537360|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537361|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537362|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537363|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537364|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537870|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537365|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537366|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537367|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537368|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537369|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537370|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537371|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537372|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537373|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537374|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537375|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537376|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537377|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537378|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537379|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537380|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537381|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537382|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537383|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537384|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537385|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537386|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537387|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537388|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537389|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537390|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537391|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537392|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537393|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537394|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537395|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537396|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537397|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537398|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537399|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537400|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537401|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537402|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537403|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537404|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537405|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537406|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537407|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537408|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537409|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537410|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537411|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537412|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537413|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537414|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537415|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537416|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537417|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537418|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537419|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537420|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537421|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537422|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537423|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537424|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537425|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537426|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537427|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537428|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537429|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537430|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537431|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537432|NCT00209339|O1|Outcome|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537433|NCT00209339|E1|Reported Event|Percutaneous Mitral Valve Repair (MitraClip Implant)|Phase I evaluation of the safety and effectiveness of an endovascular approach to the repair of mitral valve regurgitation using the Evalve MitraClip Cardiovascular Valve Repair System.
537434|NCT00209170|B3|Baseline|Total|Total of all reporting groups
537435|NCT00209170|B2|Baseline|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
537436|NCT00209170|B1|Baseline|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
537437|NCT00209170|P2|Participant Flow|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
537438|NCT00209170|P1|Participant Flow|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
537439|NCT00209170|O2|Outcome|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
537440|NCT00209170|O1|Outcome|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
537441|NCT00209170|E2|Reported Event|Beating the Blues CBT + Placebo|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with placebo (taken orally one to two tablets daily) for 6 months
537442|NCT00209170|E1|Reported Event|Beating the Blues CBT + Escitalopram|Subjects with type 2 diabetes randomized to Beating the Blues (computerized cognitive behavioral therapy) with the selective serotonin reuptake inhibitor (SSRI) antidepressant, escitalopram (10 mg taken orally once or twice daily) for 6 months
537443|NCT00209131|B3|Baseline|Total|Total of all reporting groups
537444|NCT00209131|B2|Baseline|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
537445|NCT00209131|B1|Baseline|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
537446|NCT00209131|P2|Participant Flow|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
537447|NCT00209131|P1|Participant Flow|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
537448|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
537449|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
537450|NCT00209131|O2|Outcome|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
537451|NCT00209131|O1|Outcome|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
537452|NCT00209131|E2|Reported Event|Sugar Pill|Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
537453|NCT00209131|E1|Reported Event|Flomax|Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure.
537454|NCT00209092|B3|Baseline|Total|Total of all reporting groups
537455|NCT00209092|B2|Baseline|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
537456|NCT00209092|B1|Baseline|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
537457|NCT00209092|P2|Participant Flow|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
537458|NCT00209092|P1|Participant Flow|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
537459|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
537460|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
537461|NCT00209092|O2|Outcome|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
537462|NCT00209092|O1|Outcome|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
537463|NCT00209092|E2|Reported Event|Arm B:Concurrent Therapy|Docetaxel will be given at 50mg/m^2 intravenously Day 1 concomitantly with capecitabine 1000 mg/m^2 twice a day by mouth Day 1-7 every 2 weeks for 8 cycles (total 16 weeks).
537464|NCT00209092|E1|Reported Event|Arm A:Sequential Therapy|Docetaxel will be given at 100mg/m^2 intravenously Day1 every 3 weeks for 4 cycles followed by capecitabine 1000 mg/m^2 twice a day by mouth D1-14 every 3 weeks for 4 cycles (total 8 cycles) (total 24 weeks).
537465|NCT00209027|B3|Baseline|Total|Total of all reporting groups
537466|NCT00209027|B2|Baseline|Controls|Baseline fMRI scan
537467|NCT00209027|B1|Baseline|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
537468|NCT00209027|P2|Participant Flow|Controls|Baseline fMRI scan
537469|NCT00209027|P1|Participant Flow|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
537470|NCT00209027|O2|Outcome|Controls|Healthy males without a psychiatric diagnosis
537471|NCT00209027|O1|Outcome|Schizophrenia Subjects|Males patients with schizophrenia
537472|NCT00209027|E2|Reported Event|Controls|Baseline fMRI scan
537473|NCT00209027|E1|Reported Event|Schizophrenia Subjects|Baseline fMRI, switch from baseline medication to aripiprazole, then repeat fMRI scan after 12 weeks of treatment.
537474|NCT00208975|B1|Baseline|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
537475|NCT00208975|P1|Participant Flow|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
537476|NCT00208975|O2|Outcome|Non Hodgkin Lymphoma|"Non-Hodgkin's lymphoma, also called non-Hodgkin lymphoma, is cancer that originates in your lymphatic system, the disease-fighting network spread throughout your body. In non-Hodgkin's lymphoma, tumors develop from lymphocytes — a type of white blood cell.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
537477|NCT00208975|O1|Outcome|Chronic Lymphocytic Leukemia|"Chronic Lymphocytic Leukemia (CLL) is a condition characterized by an accumulation of abnormal lymphocytes in the blood and the bone marrow. These lymphocytes do not perform their functions as normal ones would and interfere with the production of other blood cells necessary for the normal functioning of the blood, leading to a host of complications like deficiency of the immune system, coagulation problems, swollen lymph nodes, and many other conditions.~Fludarabine-based combination provide effective treatment for patients with low-grade NHL and CLL with high complete response rates that are improved with the addition of Rituximab."
537478|NCT00208975|E1|Reported Event|Fludarabine and Cyclophosphamide With Sequential Administratio|Patients will receive fludarabine and cyclophosphamide with sequential administration of GM-CSF on days 6 and 7 and rituximab on day 8.
537479|NCT00208949|B3|Baseline|Total|Total of all reporting groups
537480|NCT00208949|B2|Baseline|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
537481|NCT00208949|B1|Baseline|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
537482|NCT00208949|P2|Participant Flow|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
537483|NCT00208949|P1|Participant Flow|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
537484|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
539609|NCT00195429|E1|Reported Event|Sirolimus + Tacrolimus|
537485|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
537486|NCT00208949|O2|Outcome|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF(Granulocyte Colony-Stimulating Factor ) and GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) (G-CSF 7.5 µg/kg / GM-CSF 7.5 µg/kg.)
537487|NCT00208949|O1|Outcome|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF(Granulocyte Colony-Stimulating Factor ) G-CSF 7.5 µg/kg twice a day
537488|NCT00208949|E2|Reported Event|G-CSF and GM-CSF (Granulocyte Macrophage)|Combined use of G-CSF and GM-CSF
537489|NCT00208949|E1|Reported Event|G-CSF (Granulocyte Colony- Stimulating Factor)|Single use of G-CSF
537490|NCT00208767|B3|Baseline|Total|Total of all reporting groups
537491|NCT00208767|B2|Baseline|Placebo|Patients received a placebo instead of Valsartan
537492|NCT00208767|B1|Baseline|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
537493|NCT00208767|P2|Participant Flow|Placebo|Patients received a placebo instead of Valsartan
537494|NCT00208767|P1|Participant Flow|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
537495|NCT00208767|O2|Outcome|Placebo|Patients received a placebo instead of Valsartan
537496|NCT00208767|O1|Outcome|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
537497|NCT00208767|E2|Reported Event|Placebo|Patients received a placebo instead of Valsartan
537498|NCT00208767|E1|Reported Event|Valsartan|"Valsartan titrated up to 320 mg orally daily~Valsartan: Valsartan was titrated to a target dose of 320 mg orally daily"
537499|NCT00208507|B3|Baseline|Total|Total of all reporting groups
537500|NCT00208507|B2|Baseline|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537501|NCT00208507|B1|Baseline|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537502|NCT00208507|P2|Participant Flow|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537503|NCT00208507|P1|Participant Flow|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537504|NCT00208507|O2|Outcome|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537505|NCT00208507|O1|Outcome|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537506|NCT00208507|E2|Reported Event|Pinnacle™ Acetabular Cup With Marathon® Polyethylene|Pinnacle™ acetabular shells are a hemispherical type of acetabulum replacement prosthesis that incorporates Porocoat® porous coating for biologic fixation to host bone. The 28mm ceramic femoral heads were used with Marathon® polyethylene liners. The polyethylene insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537507|NCT00208507|E1|Reported Event|Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup System|The Delta Ceramax™ Ceramic-on-Ceramic Acetabular Cup Prosthesis System consists of a modular ceramic bearing insert that attaches to a Pinnacle™ Acetabular Shell by a taper locking mechanism. The ceramic insert is designed to articulate against a 28 mm ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis.
537508|NCT00208494|B3|Baseline|Total|Total of all reporting groups
537509|NCT00208494|B2|Baseline|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
537510|NCT00208494|B1|Baseline|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
537511|NCT00208494|P2|Participant Flow|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
537512|NCT00208494|P1|Participant Flow|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
537513|NCT00208494|O2|Outcome|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
537514|NCT00208494|O1|Outcome|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
537515|NCT00208494|E2|Reported Event|Metal-on-Metal (MOM) Total Hip Implant|The MOM modular total hip prosthesis has a metal femoral head articulating with a metal alloy acetabular bearing insert.
537516|NCT00208494|E1|Reported Event|Ceramic-on-Metal (COM) Total Hip Implant|The COM modular total hip prosthesis has a ceramic femoral head articulating with a metal alloy acetabular bearing insert.
537517|NCT00208325|B5|Baseline|Total|Total of all reporting groups
537518|NCT00208325|B4|Baseline|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537519|NCT00208325|B3|Baseline|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537520|NCT00208325|B2|Baseline|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537521|NCT00208325|B1|Baseline|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537522|NCT00208325|P4|Participant Flow|PFC Mobile Bearing PCL Retained|"Mobile bearing~P.F.C Sigma Mobile Bearing Total knee system: Orthopaedic implant for total knee replacement"
537523|NCT00208325|P3|Participant Flow|PFC Fixed Bearing PCL Retained|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
537524|NCT00208325|P2|Participant Flow|PFC Mobile Bearing PCL Sacrificed|"Mobile bearing~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537525|NCT00208325|P1|Participant Flow|PFC Fixed Bearing PCL Sacrificed|"Fixed bearing~P.F.C Sigma Fixed Bearing Total knee system: Orthopaedic implant for total knee replacement"
537526|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537527|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537528|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537529|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537530|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537531|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537532|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537533|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537534|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537535|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537536|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537537|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537538|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537539|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537540|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537541|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537542|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537543|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537544|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537545|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537546|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537547|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537548|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537549|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537550|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537551|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537552|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537553|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537554|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537555|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537556|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537557|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537558|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537559|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537560|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537561|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537562|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537563|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537564|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537565|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537566|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537567|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537568|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537569|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537570|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537571|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537572|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537573|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537574|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537575|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537576|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537577|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537578|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537579|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537580|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537581|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537688|NCT00207740|E4|Reported Event|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 wks to Wk 52
537582|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537583|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537584|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537585|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537586|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537587|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537588|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537589|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537590|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537591|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537592|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537593|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537594|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537595|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537596|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537597|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537598|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537599|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537600|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537601|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537602|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537603|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537604|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537605|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537606|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537607|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537608|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537609|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537610|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537611|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537612|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537613|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537689|NCT00207740|E3|Reported Event|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 wks to Wk 52
537614|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537615|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537616|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537617|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537618|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537619|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537620|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537621|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537622|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537623|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537624|NCT00208325|O2|Outcome|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537625|NCT00208325|O1|Outcome|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537626|NCT00208325|O2|Outcome|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537627|NCT00208325|O1|Outcome|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537628|NCT00208325|E4|Reported Event|PFC Sigma RP PCL Retained|"PFC Sigma Rotating Platform Total Knee System with PCL Retained~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537629|NCT00208325|E3|Reported Event|PFC Sigma Fixed Bearing PCL Retained|"PFC Sigma Fixed Bearing Total Knee System with PCL Retained~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537630|NCT00208325|E2|Reported Event|PFC Sigma RP PCL Sacrificed|"PFC Sigma Rotating Platform Total Knee System with PCL Sacrificed~P.F.C Sigma RP Mobile Bearing knee system: Orthopaedic implant for total knee replacement"
537631|NCT00208325|E1|Reported Event|PFC Fixed Bearing PCL Sacrificed|"PFC Sigma Fixed Bearing Total Knee System with PCL Sacrificed~P.F.C Sigma Fixed Bearing total knee system: Orthopaedic implant for total knee replacement"
537632|NCT00208091|B1|Baseline|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
537633|NCT00208091|P1|Participant Flow|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
537634|NCT00208091|O1|Outcome|Post-injection Subjective Change|Subjective assessment 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
537635|NCT00208091|O2|Outcome|Note Errors, Post-injection|Note errors (related to errors in loudness) 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
537636|NCT00208091|O1|Outcome|Note Errors, Baseline|Note errors (related to errors in loudness) were calculated as a measure of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note loudness.
537637|NCT00208091|O2|Outcome|Note Errors (Related to Errors in Duration), Post-injection|Note errors 6 weeks after diluted botulinum toxin (500 Units/0.1 ml) was injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosages varied for each patient according to symptom severity and involved muscle(s).
537638|NCT00208091|O1|Outcome|Note Errors (Related to Errors in Duration), Baseline|Note errors (related to errors in duration) were calculated as measures of difference between the affected and unaffected hand performing multiple scale sequences of 8 to 16 notes played. This was obtained by averaging sequences, note by note, for each hand and taking the square root of the mean of the square of the differences (root mean square error) in note duration.
537639|NCT00208091|E1|Reported Event|Botulinum Toxin, Type B|Diluted botulinum toxin (500 Units/0.1 ml) is injected to the affected muscle(s) through a hollow core needle using electromyographic guidance. Dosage according to muscle(s) and symptom severity. Injection occurs at first visit only, after neurological evaluation.
537640|NCT00208026|B1|Baseline|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
537641|NCT00208026|P1|Participant Flow|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
537642|NCT00208026|O1|Outcome|Pimecrolimus 1% Cream|"Treatment with drug/Elidel. Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:~Pimecrolimus 1% Cream: Open label single arm"
537643|NCT00208026|E1|Reported Event|Elidel (Pimecrolimus) 1% Cream|Treatment with drug/Elidel.Single arm-open-label treatment arm. A Pilot Study of the Efficacy and Safety of Pimecrolimus Cream 1% for the Treatment of Netherton Syndrome:
537644|NCT00207740|B5|Baseline|Total|Total of all reporting groups
537645|NCT00207740|B4|Baseline|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537646|NCT00207740|B3|Baseline|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537647|NCT00207740|B2|Baseline|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537648|NCT00207740|B1|Baseline|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537649|NCT00207740|P4|Participant Flow|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537650|NCT00207740|P3|Participant Flow|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537651|NCT00207740|P2|Participant Flow|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537652|NCT00207740|P1|Participant Flow|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537653|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537654|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537655|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537656|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537657|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537658|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537659|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537660|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537661|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537662|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
537663|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537664|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537665|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537666|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537667|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from Wk 0 to Wk 52
537668|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537669|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537670|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537671|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537672|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537673|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537674|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537675|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537676|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537677|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537678|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537679|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537680|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537681|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537682|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537683|NCT00207740|O5|Outcome|Combined: Group III & IV|Combines Group III (golimumab 100 mg) and Group IV (golimumab 200 mg)
537684|NCT00207740|O4|Outcome|Group IV: Golimumab 200 mg|Golimumab 300 mg SC injection at Wk 0 followed by 200 mg SC injections every 4 Wks to Wk 52
537685|NCT00207740|O3|Outcome|Group III: Golimumab 100 mg|Golimumab 150 mg SC injection at Wk 0 followed by 100 mg SC injections every 4 Wks to Wk 52
537686|NCT00207740|O2|Outcome|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 milligram (mg) SC injection at Wk 0 followed by 50 mg SC injections every 4 Wks to Wk 52
537687|NCT00207740|O1|Outcome|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 weeks (Wks) from week (Wk) 0 to Wk 52
537690|NCT00207740|E2|Reported Event|Group II: Golimumab 50 mg|Golimumab (CNTO148) 75 mg SC injection at Wk 0 followed by 50 mg SC injections every 4 wks to Wk 52
537691|NCT00207740|E1|Reported Event|Group I: Placebo|Placebo subcutaneous (SC) injections every 4 wks from Wk 0 to Wk 52
537692|NCT00207727|B6|Baseline|Total|Total of all reporting groups
537693|NCT00207727|B5|Baseline|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537694|NCT00207727|B4|Baseline|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537695|NCT00207727|B3|Baseline|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537696|NCT00207727|B2|Baseline|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537697|NCT00207727|B1|Baseline|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537698|NCT00207727|P5|Participant Flow|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537699|NCT00207727|P4|Participant Flow|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537700|NCT00207727|P3|Participant Flow|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537701|NCT00207727|P2|Participant Flow|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537702|NCT00207727|P1|Participant Flow|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537703|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537704|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537705|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537706|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537707|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537708|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537709|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537710|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537711|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537712|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537713|NCT00207727|O5|Outcome|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537714|NCT00207727|O4|Outcome|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537715|NCT00207727|O3|Outcome|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537716|NCT00207727|O2|Outcome|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537717|NCT00207727|O1|Outcome|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537718|NCT00207727|E5|Reported Event|Group V: Ustekinumab 180 mg Every 4 Weeks|Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537719|NCT00207727|E4|Reported Event|Group IV: Ustekinumab 90 mg Every 4 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537720|NCT00207727|E3|Reported Event|Group III: Ustekinumab 90 mg Every 8 Weeks|Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
537721|NCT00207727|E2|Reported Event|Group II: Ustekinumab 27 mg Every 4 Weeks|Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
537722|NCT00207727|E1|Reported Event|Group I: Placebo|Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
537723|NCT00207714|B6|Baseline|Total|Total of all reporting groups
537724|NCT00207714|B5|Baseline|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
537725|NCT00207714|B4|Baseline|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
537726|NCT00207714|B3|Baseline|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
537771|NCT00207142|P1|Participant Flow|Induction Treatment|Atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg, given once daily (QD) + 2 nucleoside reverse transcriptase inhibitors (NRTIs) during a 26- to 30-week Induction Phase
537727|NCT00207714|B2|Baseline|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
537728|NCT00207714|B1|Baseline|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
537729|NCT00207714|P5|Participant Flow|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
537730|NCT00207714|P4|Participant Flow|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
537731|NCT00207714|P3|Participant Flow|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
537732|NCT00207714|P2|Participant Flow|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
537733|NCT00207714|P1|Participant Flow|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
537734|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 wks).
537735|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537736|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 wks thru Wk 18 plus MTX (Weeks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Weeks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
537737|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 weeks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537738|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537739|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 wks from Wk 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 wks thru Wk 44. Continue stable dose of MTX throughout the study.
537740|NCT00207714|O6|Outcome|Combined: Groups II, III, IV & V|Combines Groups II (golimumab 50 mg plus placebo), III (golimumab 50 mg every 2/4 Wks), IV (golimumab 100 mg plus placebo) & V (golimumab 100 mg every 2/4 Wks).
537741|NCT00207714|O5|Outcome|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537742|NCT00207714|O4|Outcome|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg SC injections every 4 Wks thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded through the end of study.
537743|NCT00207714|O3|Outcome|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 mg SC injections every 2 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537772|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300mg + RTV 100mg QD + 2NRTIs
537773|NCT00207142|O1|Outcome|Switch Regimen|ATV 400mg QD + 2NRTIs
537871|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537744|NCT00207714|O2|Outcome|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 mg SC injections every 4 Wks from Wk 0 thru Wk 18 plus MTX (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Participants continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Participants remained blinded thru the end of study.
537745|NCT00207714|O1|Outcome|Group I: Placebo Crossover to Infliximab|Placebo SC injections every 2 weeks (Wks) from week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab IV infusions: 3 mg/kg at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
537746|NCT00207714|E5|Reported Event|Group V: Golimumab 100 mg Every 2 or 4 Weeks|Golimumab 100 milligrams (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group V: Golimumab 100 mg every 2 or 4 Wks.
537747|NCT00207714|E4|Reported Event|Group IV: Golibumab 100 mg Every 4 Weeks|Golimumab 100 mg subcutaneous (SC) injections every 4 weeks (Wks) thru Week (Wk) 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 100 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded through the end of study. Also referred to as Group IV: golimumab 100 mg plus placebo every 4 Wks.
537748|NCT00207714|E3|Reported Event|Group III: Golimumab 50 mg Every 2 or 4 Weeks|Golimumab 50 miligram (mg) subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks through Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as GroupIII: Golimumab 50 mg every 2 or 4 Wks.
537749|NCT00207714|E2|Reported Event|Group II: Golimumab 50 mg Every 4 Weeks|Golimumab (CNTO148) 50 milligram (mg) subcutaneous (SC) injections every 4 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus methotrexate (MTX) (Wks 0, 4, 8, 12, and 16); Placebo SC injections were to be administered at interim visits (Wks 2, 6, 10, 14, and 18) plus MTX. Patients continued at 50 mg of golimumab at Wk 20, and then every 4 Wks thru Wk 48. Continue stable dose of MTX throughout the study. Patients remained blinded thru the end of study. Also referred to as Group II: golimumab 50 mg plus placebo every 4 Wks.
537750|NCT00207714|E1|Reported Event|Group I: Placebo Crossover to Infliximab|Placebo subcutaneous (SC) injections every 2 weeks (Wks) from Week (Wk) 0 thru Wk 18 plus Methotrexate (MTX) (Wks 0, 2, 4, 6, 8, 10, 12, 14, 16, and 18); after all study evaluations at Wk 20, open-label infliximab intravenous (IV) infusions: 3 milligrams per kilogram (mg/kg) at Wks 20, 22, 28 and then every 8 Wks thru Wk 44. Continue stable dose of MTX throughout the study.
537751|NCT00206440|B3|Baseline|Total|Total of all reporting groups
537752|NCT00206440|B2|Baseline|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
537753|NCT00206440|B1|Baseline|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
537754|NCT00206440|P2|Participant Flow|Sugar Pill|Subjects will be given placebo(surgar pill) 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
537755|NCT00206440|P1|Participant Flow|Esomeprazole|Subjects will be given esomeprazole 40mg daily by mouth for Cycle 1 Days 1-5 and Cycle 2 Days 1-5.
537756|NCT00206440|O2|Outcome|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
537757|NCT00206440|O1|Outcome|Esomeprazole|The first dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
537758|NCT00206440|E2|Reported Event|Sugar Pill|The frist dose of sugar pill 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
537759|NCT00206440|E1|Reported Event|Esomeprazole|The frist dose of esomeprazole 40 mg will be administrated prior to the initiation of chemotherapy along with the standard antiemetics for each cycle. On day 2 to 5 following chemotherapy, the patient will take one capsule each morning.
537760|NCT00206427|B1|Baseline|GW572016 1500mg|patients received GW572016 1500mg daily
537761|NCT00206427|P1|Participant Flow|GW572016 1500mg|The study had only 1 treatment group and all patient had GW572016 1500mg daily.
537762|NCT00206427|O1|Outcome|GW572016 1500mg|patients received GW572016 1500mg daily
537763|NCT00206427|E1|Reported Event|GW572016 1500mg|patients received GW572016 1500mg daily
537764|NCT00207142|B4|Baseline|Total|Total of all reporting groups
537765|NCT00207142|B3|Baseline|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase: ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537766|NCT00207142|B2|Baseline|Randomized Subjects: Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537767|NCT00207142|B1|Baseline|Randomized Subjects: Switch Regimen|ATV 400 mg QD + 2 NRTIs
537768|NCT00207142|P4|Participant Flow|Rescue Treatment|Participants without confirmed undetectable viral load at the end of Induction Phase were not randomized, but were offered to continue on ATV 300 mg + RTV 100 mg QD + 2 NRTIs for an additional 48 weeks (continued previous NRTI).
537769|NCT00207142|P3|Participant Flow|Maintenance Treatment: Continuation Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase) at the end of Induction Phase, who were then randomized to ATV 300 mg + RTV 100 mg QD for an additional 48 weeks (continued previous NRTI).
537770|NCT00207142|P2|Participant Flow|Maintenance Treatment: Switch Regimen|Participants with confirmed undetectable viral load (ie, HIV-1 RNA viral load < 50 c/mL on 2 consecutive on-treatment measurements performed from Week 16 up until Week 28 of the Induction Phase), at the end of Induction Phase, who were then randomized to ATV 400 mg QD for an additional 48 weeks (continued previous NRTI).
537774|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537775|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537776|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537777|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537778|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537779|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537780|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
537781|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
537782|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
537783|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400mg QD + 2NRTIs) or Continuation Regimen (ATV 300mg + RTV 100mg QD + 2NRTIs)
537784|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537785|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537786|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537787|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537788|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537789|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537790|NCT00207142|O1|Outcome|Rescue Treatment|Nonrandomized participants completing Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537791|NCT00207142|O3|Outcome|Total|All participants treated with Induction Phase therapy (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537792|NCT00207142|O2|Outcome|Nonrandomized Subjects|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537793|NCT00207142|O1|Outcome|Randomized Subjects|All participants who were randomized at the end of Induction Phase to receive either Switch Regimen (ATV 400 mg QD + 2 NRTIs) or Continuation Regimen (ATV 300 mg + RTV 100 mg QD + 2 NRTIs)
537794|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537795|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537796|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537797|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537798|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537799|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537800|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537801|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537802|NCT00207142|O2|Outcome|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537803|NCT00207142|O1|Outcome|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537804|NCT00207142|E3|Reported Event|Non-Randomized Participants|All participants entering Rescue Phase after Induction Phase or discontinued during Induction Phase (ATV 300mg + RTV 100mg QD + 2NRTIs)
537805|NCT00207142|E2|Reported Event|Continuation Regimen|ATV 300 mg + RTV 100 mg QD + 2 NRTIs
537806|NCT00207142|E1|Reported Event|Switch Regimen|ATV 400 mg QD + 2 NRTIs
537807|NCT00207090|B1|Baseline|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537808|NCT00207090|P1|Participant Flow|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537857|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537858|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537859|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537860|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537809|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537810|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
537811|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537812|NCT00207090|O1|Outcome|Ixabepilone + Rifampin|Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2.
537813|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537814|NCT00207090|O1|Outcome|All Participants|All participants who were enrolled into the study, 24 hours before ixabepilone administration on Day -1. Each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2 on Day 1 of Cycle 1. Each participant was administered an oral dose of 600 mg of rifampin while in a fasted state on Day 22 (Cycle 2). Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23 through 28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food during Cycle 2.
537815|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537816|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537817|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537818|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537819|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537861|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537820|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537821|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537822|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537823|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537824|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537825|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537826|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537827|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537828|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537829|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537862|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537863|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537864|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537865|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537866|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537867|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
541154|NCT00186901|O1|Outcome|Male|218 males were eligible for the study
537830|NCT00207090|O1|Outcome|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537831|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537832|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537833|NCT00207090|O2|Outcome|Ixabepilone + Rifampin|Having already received ixabepilone on Day 1 of Cycle 1 (see the “ixabepilone” treatment arm), participants were administered an oral dose of 600 mg rifampin on in the clinic on Day 15. On Days 16-21, participants self-administered rifampin once daily, at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537834|NCT00207090|O1|Outcome|Ixabepilone|On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. (Participants then proceeded through the rest of Cycle 1 and on to further cycles – see the “ixabepilone + rifampin” treatment arm).
537835|NCT00207090|E1|Reported Event|All Participants|All treated participants who received at least 1 dose of study drug. On Day 1 of Cycle 1, each participant received a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Day 15, participants were administered an oral dose of 600 mg rifampin in the clinic and on Days 16-21, participants self-administered rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. On Day 22 (Cycle 2), participants were administered an oral dose of 600 mg of rifampin while in a fasted state in the clinic. Participants were then administered a single 3-hour IV infusion of ixabepilone 40 mg/m^2. On Days 23-28, participants self-administered a 600-mg oral dose of rifampin once daily at least 1 hour before or 2 hours after the ingestion of food. During Cycle 3 and beyond, participants received a single 3-hour IV infusion of ixabepilone at a dose of 40 mg/m^2 (unless their dose had been reduced) on Day 1 of each 21-day cycle for a maximum of 6 full cycles.
537836|NCT00206726|B1|Baseline|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537837|NCT00206726|P1|Participant Flow|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537838|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537839|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537840|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537841|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537842|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537843|NCT00206726|O1|Outcome|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537844|NCT00206726|E1|Reported Event|Alemtuzumab Plus Fludarabine|Alemtuzumab (Campath) 30mg subcutaneous (SC) plus Fludarabine (Fludara) 25mg/m² intravenous (IV), Days 1-5 every 28 days
537845|NCT00206102|B3|Baseline|Total|Total of all reporting groups
537846|NCT00206102|B2|Baseline|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537847|NCT00206102|B1|Baseline|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537848|NCT00206102|P2|Participant Flow|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537849|NCT00206102|P1|Participant Flow|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537850|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537851|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537852|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537853|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537854|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537855|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537856|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537872|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537873|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537874|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537875|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537876|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537877|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537878|NCT00206102|O2|Outcome|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537879|NCT00206102|O1|Outcome|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537880|NCT00206102|E2|Reported Event|Risperidone|Risperidone - flexibly dosed (2 - 8 mg/day)
537881|NCT00206102|E1|Reported Event|Quetiapine Fumarate|Quetiapine fumarate - flexibly dosed (200 - 800 mg/day)
537882|NCT00206076|B3|Baseline|Total|Total of all reporting groups
537883|NCT00206076|B2|Baseline|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
537884|NCT00206076|B1|Baseline|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
537885|NCT00206076|P2|Participant Flow|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
537886|NCT00206076|P1|Participant Flow|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
537887|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
537888|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
537889|NCT00206076|O2|Outcome|CNI Reduction|calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment
537890|NCT00206076|O1|Outcome|CNI Discontinued|complete withdrawal of calcineurin inhibitors (CNI)
537891|NCT00206076|O2|Outcome|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
537892|NCT00206076|O1|Outcome|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
537893|NCT00206076|E2|Reported Event|MMF; CNI Decreased|Received Mycophenolate Mofetil (MMF); calcineurin inhibitors (CNI) decreased to 50% of pre-enrollment dosage
537894|NCT00206076|E1|Reported Event|MMF, CNI Discontinued|Received Mycophenolate Mofetil (MMF); Complete withdrawal of calcineurin inhibitors (CNI)
537895|NCT00205881|B1|Baseline|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
537896|NCT00205881|P1|Participant Flow|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
537897|NCT00205881|O2|Outcome|8 Months Post-device Activation|Testing conducted with bilateral implants.
537898|NCT00205881|O1|Outcome|Baseline|Testing with hearing aids in best-aided condition.
537899|NCT00205881|E1|Reported Event|Bilaterally Implanted|31 Subjects were bilaterally implanted with Bionic ear systems within the same surgery. 1 Subject was unilaterally implanted.
537900|NCT00205855|B1|Baseline|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
537901|NCT00205855|P1|Participant Flow|Spinal Cord Stimulation (SCS) Group|"Upon meeting entry criteria and a baselineline evaluation all eligible subjects then receive either a temporary lead or a permanent lead (both leads are considered trial durign this phase) attached to an external stimulator for a minimum period of 48 hours. Patients who are determined to have 50% improvement in the VAS score from baseline after the trial phase were implanted with the Precision Spinal Cord Stimulation System."
537902|NCT00205855|O1|Outcome|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
537903|NCT00205855|E1|Reported Event|Spinal Cord Stimulation (SCS) Group|Precision Spinal Cord Stimulation therapy group
537904|NCT00205803|B3|Baseline|Total|Total of all reporting groups
537905|NCT00205803|B2|Baseline|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537906|NCT00205803|B1|Baseline|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537907|NCT00205803|P2|Participant Flow|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537908|NCT00205803|P1|Participant Flow|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537909|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537910|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
542327|NCT00177294|B3|Baseline|Total|Total of all reporting groups
537911|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537912|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537913|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537914|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537915|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537916|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537917|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537918|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537919|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
537920|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series).
537921|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537922|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537923|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537924|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537925|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537926|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537927|NCT00205803|O4|Outcome|7vPnC After Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537928|NCT00205803|O3|Outcome|13vPnC After Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537929|NCT00205803|O2|Outcome|7vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
537930|NCT00205803|O1|Outcome|13vPnC Before Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
537931|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537932|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537933|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537934|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537935|NCT00205803|O2|Outcome|7vPnC|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537936|NCT00205803|O1|Outcome|13vPnC|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537937|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537938|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537939|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
537940|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
537941|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
537942|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
537943|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
537944|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
537945|NCT00205803|O8|Outcome|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537946|NCT00205803|O7|Outcome|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537947|NCT00205803|O6|Outcome|7vPnC Dose 3|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
537948|NCT00205803|O5|Outcome|13vPnC Dose 3|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 6 months of age (infant series Dose 3).
537949|NCT00205803|O4|Outcome|7vPnC Dose 2|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
537950|NCT00205803|O3|Outcome|13vPnC Dose 2|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 4 months of age (infant series Dose 2).
537951|NCT00205803|O2|Outcome|7vPnc Dose 1|Participants received one single 0.5mL dose of 7vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
537952|NCT00205803|O1|Outcome|13vPnC Dose 1|Participants received one single 0.5mL dose of 13vPnC coadministered with Pediarix and ActHIB at 2 months of age (infant series Dose 1).
537953|NCT00205803|E6|Reported Event|7vPnC 6-Month Follow-up|Participants received one single 0.5mL dose of 7-valent pneumococcal conjugate vaccine (7vPnC) coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537954|NCT00205803|E5|Reported Event|13vPnC 6-Month Follow-up|Participants received one single 0.5 mL dose of 13-valent pneumococcal conjugate vaccine (13vPnC) coadministered with Haemophilus b Conjugate Vaccine (ActHIB) and Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Hepatitis B (Recombinant) and Inactivated Poliovirus Vaccine Combined (Pediarix) at 2, 4, 6 months (infant series). Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12-15 months of age (toddler dose).
537955|NCT00205803|E4|Reported Event|7vPnC Toddler Dose|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537956|NCT00205803|E3|Reported Event|13vPnC Toddler Dose|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB at 12 to 15 months of age (toddler dose).
537957|NCT00205803|E2|Reported Event|7vPnC Infant Series|Participants received one single 0.5mL dose of 7vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
537958|NCT00205803|E1|Reported Event|13vPnC Infant Series|Participants received one single 0.5mL dose of 13vPnC coadministered with ActHIB and Pediarix at 2, 4, 6 months (infant series).
537959|NCT00205777|B5|Baseline|Total|Total of all reporting groups
537960|NCT00205777|B4|Baseline|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538217|NCT00205049|B1|Baseline|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
537961|NCT00205777|B3|Baseline|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537962|NCT00205777|B2|Baseline|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537963|NCT00205777|B1|Baseline|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537964|NCT00205777|P6|Participant Flow|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537965|NCT00205777|P5|Participant Flow|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537966|NCT00205777|P4|Participant Flow|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537967|NCT00205777|P3|Participant Flow|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537968|NCT00205777|P2|Participant Flow|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537969|NCT00205777|P1|Participant Flow|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 milligram (mg) capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537970|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537971|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537972|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537973|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537974|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537975|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537976|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537977|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537978|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537979|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537980|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537981|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537982|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537983|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537984|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538077|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537985|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537986|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537987|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537988|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537989|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537990|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537991|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537992|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537993|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537994|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537995|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537996|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537997|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
537998|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
537999|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538000|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538001|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538002|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538003|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538004|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538005|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538006|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538007|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538008|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538218|NCT00205049|P2|Participant Flow|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
538009|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538010|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538011|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538012|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538013|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538014|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538015|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538016|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538017|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538018|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538019|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538020|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538021|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538022|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538023|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538024|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538025|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538026|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538027|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538028|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538029|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538030|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538123|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538031|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538032|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538033|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538034|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538035|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538036|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538037|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538038|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538039|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538040|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538041|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538042|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538043|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538044|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538045|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538046|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538047|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538048|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538049|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538050|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538051|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538052|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538053|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538054|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538055|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538056|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538057|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538058|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538059|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538060|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538061|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538062|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538063|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538064|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538065|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538066|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538067|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538068|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538069|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538070|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538071|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538072|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538073|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538074|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538075|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538076|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538225|NCT00204932|B2|Baseline|Placebo|3 grams per day of sunflower oil for 7 months
538078|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538079|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538080|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538081|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538082|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538083|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538084|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538085|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538086|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538087|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538088|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538089|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538090|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538091|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538092|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538093|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538094|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538095|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538096|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538097|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538098|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538099|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538100|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
542793|NCT00174785|P2|Participant Flow|Placebo|matching placebo tablets
538101|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538102|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538103|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538104|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538105|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538106|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538107|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538108|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538109|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538110|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538111|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538112|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538113|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538114|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538115|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538116|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538117|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538118|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538119|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538120|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538121|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538122|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538219|NCT00205049|P1|Participant Flow|Pentoxifylline|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
538124|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538125|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538126|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538127|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538128|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538129|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538130|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538131|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538132|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538133|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538134|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538135|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538136|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538137|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538138|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538139|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538140|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538141|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538142|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538143|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538144|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538145|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538168|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538220|NCT00205049|O2|Outcome|Placebo|
538146|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538147|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538148|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538149|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538150|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538151|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538152|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538153|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538154|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538155|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538156|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538157|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538158|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538159|NCT00205777|O3|Outcome|Raloxifene 60 mg (Core)|Raloxifene 60 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538160|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538161|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538162|NCT00205777|O2|Outcome|Bazedoxifene 20 mg (SE II)|Participants from Bazedoxifene 20 mg and Bazedoxifene 40/20 mg treatment arm received bazedoxifene 20 mg capsule orally once daily for further 2 years in study extension II, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538163|NCT00205777|O1|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538164|NCT00205777|O3|Outcome|Bazedoxifene 40/20 mg (SE I)|Participants from Bazedoxifene 40 mg treatment arm continued to receive bazedoxifene acetate 40 mg capsule orally once daily in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538165|NCT00205777|O2|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsules orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538166|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538167|NCT00205777|O4|Outcome|Placebo (Core+SE I+SE II)|Matching placebo capsule orally once daily for 3 years in the core study, further 2 years in study extension I (SE I) and further 2 years in study extension II (SE II), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538216|NCT00205049|B2|Baseline|Placebo|All subjects will be randomized to receive either pentoxifylline 400mg orally or placebo 3 times daily for 28 days
538169|NCT00205777|O2|Outcome|Bazedoxifene 40 mg (Core)|Bazedoxifene acetate 40 mg capsule orally once daily for 3 years in the core study, along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538170|NCT00205777|O1|Outcome|Bazedoxifene 20 mg (Core+SE I)|Bazedoxifene acetate 20 mg capsule orally once daily for 3 years in the core study and further 2 years in study extension I (SE I), along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 international unit [IU]) orally twice daily.
538171|NCT00205777|E4|Reported Event|Placebo|Matching placebo capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in the core study, study extension I and II.
538172|NCT00205777|E3|Reported Event|Raloxifene 60 mg (Core Study)|Raloxifene 60 mg capsule orally once daily in the core study along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538173|NCT00205777|E2|Reported Event|Bazedoxifene 40/ 20 mg|Bazedoxifene acetate 40 mg capsule orally once daily in the core study, in first year of study extension I and then dose reduced to bazedoxifene acetate 20 mg in second year of study extension I, and II along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily.
538174|NCT00205777|E1|Reported Event|Bazedoxifene 20 mg|Bazedoxifene acetate 20 mg capsule orally once daily along with supplement tablet (containing calcium up to 600 mg and vitamin D up to 400 IU) orally twice daily in core study, study extension I and II.
538175|NCT00205712|B3|Baseline|Total|Total of all reporting groups
538176|NCT00205712|B2|Baseline|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
538177|NCT00205712|B1|Baseline|Ketamine Alone|ketamine without dexmedetomidine
538178|NCT00205712|P2|Participant Flow|Ketamine Plus Dexmedetomidine|Ketamine infusion plus dexmedetomidine
538179|NCT00205712|P1|Participant Flow|Ketamine Alone|Ketamine without dexmedetomidine
538180|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
538181|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
538182|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
538183|NCT00205712|O1|Outcome|Ketamine Alone|Ketamine without dexmedetomidine
538184|NCT00205712|O2|Outcome|Ketamine Plus Dexmedetomidine|ketamine infusion plus dexmedetomidine
538185|NCT00205712|O1|Outcome|Ketamine Alone|ketamine without dexmedetomidine
538186|NCT00205712|E2|Reported Event|Ketamine Plus Dexmedetomidine|Ketamine infusion with dexmedetomidine
538187|NCT00205712|E1|Reported Event|Ketamine Alone|Ketamine without dexmedetomidine
538188|NCT00205504|B3|Baseline|Total|Total of all reporting groups
538189|NCT00205504|B2|Baseline|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
538190|NCT00205504|B1|Baseline|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
538191|NCT00205504|P2|Participant Flow|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
538192|NCT00205504|P1|Participant Flow|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
538193|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538194|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538195|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538196|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538197|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538198|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538199|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
538200|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
538201|NCT00205504|O2|Outcome|Lean Women|Women with BMI >25 kg/m²
538202|NCT00205504|O1|Outcome|Obese Women|Women with BMI >30 kg/m²
538203|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538204|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538205|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
538206|NCT00205504|O1|Outcome|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
538207|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538208|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538209|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538210|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538211|NCT00205504|O2|Outcome|Lean Women|Women with Body Mass Index (BMI) <25 kg/m²
538212|NCT00205504|O1|Outcome|Obese Women|Women with Body Mass Index (BMI) >30 kg/m²
538213|NCT00205504|E2|Reported Event|Lean Women|Women with Body Mass Index)BMI <25 kg/m²
538214|NCT00205504|E1|Reported Event|Obese Women|"Women with Body Mass Index (BMI) >30 kg/m².~Note: Only two arms were analyzed for the results. Women who were candidates for taking oral contraceptive pills and had the metabolic syndrome could not be recruited. That is because some inclusion criteria for metabolic syndrome are actually exclusion criteria for safe oral contraceptive use."
538215|NCT00205049|B3|Baseline|Total|Total of all reporting groups
538221|NCT00205049|O1|Outcome|Pentoxifylline|
538226|NCT00204932|B1|Baseline|Conjugated Linoleic Acid|3 grams per day for 7 months
538227|NCT00204932|P2|Participant Flow|Placebo|4 grams per day of sunflower oil for 6 months
538228|NCT00204932|P1|Participant Flow|Conjugated Linoleic Acid|4 grams per day of 78% CLA for 6 months
538229|NCT00204932|O2|Outcome|Placebo|3 grams per day of sunflower oil for 7 months
538230|NCT00204932|O1|Outcome|Conjugated Linoleic Acid|3 grams per day for 7 months
538231|NCT00204932|E2|Reported Event|Placebo|4 grams per day of sunflower oil for 6 months
538232|NCT00204932|E1|Reported Event|Conjugated Linoleic Acid|4 grams of 78% active CLA per day for 6 months
538233|NCT00204373|B1|Baseline|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
538234|NCT00204373|P1|Participant Flow|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
538235|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
538236|NCT00204373|O1|Outcome|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
538237|NCT00204373|E1|Reported Event|Single Group|This is an open label, non-randomized, uncontrolled, single group study designed to treat patients with Zollinger-Ellison Syndrome and other hypersecretory conditions by controlling gastric acid production; to heal and prevent relapses of peptic ulcers and symptoms; to monitor the safety and efficacy of this treatment.
538238|NCT00203996|B7|Baseline|Total|Total of all reporting groups
538239|NCT00203996|B6|Baseline|Aim 3: All Participants|Includes groups randomized to any experimental ordering in Aim 3
538240|NCT00203996|B5|Baseline|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538241|NCT00203996|B4|Baseline|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538242|NCT00203996|B3|Baseline|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538243|NCT00203996|B2|Baseline|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538244|NCT00203996|B1|Baseline|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538245|NCT00203996|P10|Participant Flow|Aim 3: Baseline - SWS Supp - REM Frag|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed."
538246|NCT00203996|P9|Participant Flow|Aim 3: SWS Supp - REM Frag - Baseline|"Each subject was assessed under three experimental conditions in the following order.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
538247|NCT00203996|P8|Participant Flow|Aim 3: Baseline - REM Frag - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
538248|NCT00203996|P7|Participant Flow|Aim 3: REM Frag - Baseline - SWS Supp|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed."
538249|NCT00203996|P6|Participant Flow|Aim 3: REM Frag - SWS Supp - Baseline|"Each subject was assessed under three experimental conditions in the following order.~REM fragmentation: Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.~SWS suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.~Baseline: Baseline sleep (i.e., with no experimental intervention) assessment is recorded. This assessment may have been recorded as the first, second, or third intervention."
538250|NCT00203996|P5|Participant Flow|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538251|NCT00203996|P4|Participant Flow|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538252|NCT00203996|P3|Participant Flow|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538253|NCT00203996|P2|Participant Flow|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538254|NCT00203996|P1|Participant Flow|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538255|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
538256|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
538257|NCT00203996|O2|Outcome|Aim 3: SWS Suppression|Slow wave sleep (SWS) suppression: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
538258|NCT00203996|O1|Outcome|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
538259|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538260|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538261|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538262|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538263|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538264|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538265|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538266|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538267|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538268|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538269|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538270|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538271|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538272|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538273|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538274|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538275|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538276|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538277|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538278|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538279|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538280|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538281|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538282|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538283|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538284|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538285|NCT00203996|O2|Outcome|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538286|NCT00203996|O1|Outcome|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538287|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538288|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538289|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538290|NCT00203996|O3|Outcome|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538291|NCT00203996|O2|Outcome|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538292|NCT00203996|O1|Outcome|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538293|NCT00203996|E7|Reported Event|Aim 3: SWS Suppression|SWS: Slow wave activity will be suppressed without awakening the subject and REM sleep will be left undisturbed.
538294|NCT00203996|E6|Reported Event|Aim 3: REM Fragmentation|Rapid eye movement (REM) sleep will be fragmented by experimentally induced microarousals for 3 consecutive nights and non-REM sleep will be left undisturbed.
538295|NCT00203996|E5|Reported Event|Aim 2: Matched Controls With CPAP|One of the 2 study groups in Aim 2: Women who were of similar age to those in the PCOS+SDB group were treated with 8 weeks of continuous positive airway pressure (CPAP).
538296|NCT00203996|E4|Reported Event|Aim 2: PCOS + SDB With CPAP|One of the 2 study groups in Aim 2: Women with polycystic ovary syndrome (PCOS) and sleep disordered breathing (SDB) were treated with 8 weeks of continuous positive airway pressure (CPAP).
538297|NCT00203996|E3|Reported Event|Aim 1: Leuprolide + Estrogen/Progestin|One of the 3 treatment arms in Aim 1: Leuprolide + estrogen/progestin replacement. No subjects were randomized to this arm.
538298|NCT00203996|E2|Reported Event|Aim 1: Pioglitazone|One of the 3 treatment arms in Aim 1: Pioglitazone. No subjects were randomized to this arm.
538299|NCT00203996|E1|Reported Event|Aim 1: Placebo|One of the 3 treatment arms in Aim 1: Placebo. No subjects were randomized to this arm.
538300|NCT00203931|B3|Baseline|Total|Total of all reporting groups
538301|NCT00203931|B2|Baseline|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538302|NCT00203931|B1|Baseline|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538303|NCT00203931|P2|Participant Flow|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538304|NCT00203931|P1|Participant Flow|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538305|NCT00203931|O2|Outcome|Good Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
538306|NCT00203931|O1|Outcome|Poor Prognosis|"VeriStrat assigned classification based on mass spectrometry-based assay of serum samples collect at baseline. Details of how this was done is provided in Mass spectrometry to classify non-small-cell lung cancer patients for clinical outcome after treatment with epidermal growth factor receptor tyrosine kinase inhibitors: a multicohort cross-institutional study. by Taguchi et al. in J Natl Cancer Inst 2007 99(11): 838-46."
538307|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538308|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538309|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538310|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538311|NCT00203931|O2|Outcome|No Early Rash|Absence of rash (grade 1 or higher) by day 21 of cetuximab therapy
538312|NCT00203931|O1|Outcome|Early Rash|Presence of rash (grade 1 or higher) by day 21 of cetuximab therapy
538313|NCT00203931|O2|Outcome|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538314|NCT00203931|O1|Outcome|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538315|NCT00203931|E2|Reported Event|Cetuximab and Pemetrexed|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes. Starting on day 15 and then subsequently on day 1 of each 21 day cycle, Pemetrexed 500 mg/m2.
538316|NCT00203931|E1|Reported Event|Cetuximab|Cetuximab initial dosage of 400 mg/m2 over 120 minutes, followed by weekly infusions at 250 mg/m2 over 60 minutes.
538317|NCT00203892|B4|Baseline|Total|Total of all reporting groups
538318|NCT00203892|B3|Baseline|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538319|NCT00203892|B2|Baseline|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538343|NCT00203476|B2|Baseline|Colestipol|Colestipol added to max dose statin
538344|NCT00203476|B1|Baseline|Niacin|Niacin added to max tolerated dose of statin
543743|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
538320|NCT00203892|B1|Baseline|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538321|NCT00203892|P3|Participant Flow|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538322|NCT00203892|P2|Participant Flow|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538323|NCT00203892|P1|Participant Flow|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538324|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538325|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538326|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538327|NCT00203892|O3|Outcome|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538328|NCT00203892|O2|Outcome|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538329|NCT00203892|O1|Outcome|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538330|NCT00203892|E3|Reported Event|C: CEA Peptide 1000mcg|Vaccine contained the modified CEA peptide (1000mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538331|NCT00203892|E2|Reported Event|B: CEA Peptide 100 mcg|Vaccine contained the modified CEA peptide (100mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538332|NCT00203892|E1|Reported Event|A: CEA Peptide 10mcg|Vaccine contained the modified CEA peptide (10mcg), Montanide ISA-51, and sargramostim (GM-CSF) 250mcg. Vaccine was administered on Day 1 of each 14 day cycle until progressive disease or dose-limiting toxicity for a maximum of 24 cycles. Vaccine administration site was the proximal thigh.
538333|NCT00203502|B1|Baseline|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538334|NCT00203502|P1|Participant Flow|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538335|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538336|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538337|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538338|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538339|NCT00203502|O1|Outcome|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538340|NCT00203502|E1|Reported Event|Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin|"Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2~+ Avastin 15 mg/kg~Q 3 weeks X 4 cycles~Bevacizumab/Avastin: IV 15mg/kg 21 days~Cyclophosphamide: 500mg per meter squared, IV every 21 days~Doxorubicin: 60 mg per meter squared, IV every 21 days"
538341|NCT00203476|B4|Baseline|Total|Total of all reporting groups
538342|NCT00203476|B3|Baseline|Ezetimibe|Ezetimibe added to max tolerated dose statin
538345|NCT00203476|P3|Participant Flow|Ezetimibe|Ezetimibe added to max tolerated dose statin
538346|NCT00203476|P2|Participant Flow|Colestipol|Colestipol added to max dose statin
538347|NCT00203476|P1|Participant Flow|Niacin|Niacin added to max tolerated dose of statin
538348|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
538349|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
538350|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
538351|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
538352|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
538353|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
538354|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
538355|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
538356|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
538357|NCT00203476|O3|Outcome|Ezetimibe|Ezetimibe added to max tolerated dose statin
538358|NCT00203476|O2|Outcome|Colestipol|Colestipol added to max dose statin
538359|NCT00203476|O1|Outcome|Niacin|Niacin added to max tolerated dose of statin
538360|NCT00203476|E3|Reported Event|Ezetimibe|Ezetimibe added to max tolerated dose statin
538361|NCT00203476|E2|Reported Event|Colestipol|Colestipol added to max dose statin
538362|NCT00203476|E1|Reported Event|Niacin|Niacin added to max tolerated dose of statin
538363|NCT00203424|B1|Baseline|Erlotinib + Bevacizumab|Participants that entered treatment period.
538364|NCT00203424|P1|Participant Flow|Erlotinib + Bevacizumab|27 participants were screened for the study. 4 did not meet eligibility criteria,23 were registered to treatment period. 1 withdrew consent a day after registration and did not initiate study treatment.22 participants entered treatment period. Participants received Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses. The protocol instructed that pts be treated for 6 cycles. Of the 22 pts that started treatment, 11 completed the 6 cycles and the other 11 had to stop treatment prior to administration of 6th cycle. Of the 11 pts that did not complete all 6 cycles, 5 stopped treatment due to adverse event and were entered into the follow-up period. The 6 that stopped treatment due to withdrawal of consent and progressive disease did not enter the follow-up period. So 11 pts that completed 6 cycles of treatment plus 5 pts that did not complete 6 cycles of treatment due to an adverse event gives a total of 16 patients who entered follow-up period.
538365|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
538366|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
538367|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
538368|NCT00203424|O1|Outcome|Bevacizumab+Erlotinib|
538369|NCT00203424|E1|Reported Event|Erlotinib + Bevacizumab|Participants that entered treatment period.
538370|NCT00203411|B1|Baseline|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538371|NCT00203411|P1|Participant Flow|Bevacizumab Plus Capecitabine|"Bevacizumab 7.5 mg/kg every 3 weeks will be administered interavenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.~Capecitabine (Xeloda): 1000mg/m2 administered orally twice daily for two weeks followed by one week rest period~Bevacizumab: 7.5 mg/kg IV will be administered every 3 weeks"
538372|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538373|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538374|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538375|NCT00203411|O1|Outcome|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538376|NCT00203411|E1|Reported Event|Bevacizumab Plus Capecitabine|Bevacizumab 7.5 mg/kg every 3 weeks will be administered intravenously (IV) to the enrolled patients. Oral capecitabine 1000 mg/m^2 twice daily for 14 days followed by 7 days off every 21 days. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of patient consent.
538377|NCT00203307|B3|Baseline|Total|Total of all reporting groups
538378|NCT00203307|B2|Baseline|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
538379|NCT00203307|B1|Baseline|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
538380|NCT00203307|P2|Participant Flow|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
538381|NCT00203307|P1|Participant Flow|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
538382|NCT00203307|O2|Outcome|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
538623|NCT00201448|O1|Outcome|Placebo (Hepatitis A)|"Placebo group~Hepatitis A Vaccine: Single dose give IM"
538624|NCT00201448|O2|Outcome|Towne CMV Vaccine|
538383|NCT00203307|O1|Outcome|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
538384|NCT00203307|E2|Reported Event|Placebo First, Then Olanzapine|Matching placebo during first intervention period, then olanzapine (5-10 mg. daily) during second intervention period (after washout period).
538385|NCT00203307|E1|Reported Event|Olanzapine First, Then Placeb|Olanzapine (5-10 mg daily) during first intervention period and matching placebo in second intervention period (after washout period)
538386|NCT00203294|B3|Baseline|Total|Total of all reporting groups
538387|NCT00203294|B2|Baseline|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538388|NCT00203294|B1|Baseline|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538389|NCT00203294|P2|Participant Flow|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538390|NCT00203294|P1|Participant Flow|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538391|NCT00203294|O2|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Triamcinolone 40 mg.|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
538392|NCT00203294|O1|Outcome|Lidocaine 2% and Bupivacaine 0.25% Plus Saline|Adult patients with Chronic Daily Headache (CDH), and headache of at least moderate intensity at time of treatment, were randomized to receive bilateral GONB and 12 trigger point injections
538393|NCT00203294|E2|Reported Event|GON Block Plus Steroid|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus triamcinolone 40 mg. Two cc were injected to each GON and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538394|NCT00203294|E1|Reported Event|GON Block Only|Patients were injected with lidocaine 2% and bupivacaine 0.5% (in a 1:1 ratio) plus saline. Two cc were injected to each GON (greater occipital nerve) and 0.5 cc to each trigger point, to a total injected volume of 10 cc.
538395|NCT00203268|B1|Baseline|Treatment Group|Subjects who treated a moderate to severe migraine 2 hours and 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
538396|NCT00203268|P1|Participant Flow|Treatment Group|Subjects who treated a moderate to severe migraine at 1 hour and at 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. intramuscular (IM). Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
538397|NCT00203268|O2|Outcome|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
538398|NCT00203268|O1|Outcome|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
538399|NCT00203268|E2|Reported Event|Late Treatment|Subjects who treated a moderate to severe migraine 4 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe
538400|NCT00203268|E1|Reported Event|Early Treatment|Subjects who treated a moderate to severe migraine 2 hours after the onset of throbbing pain. Subjects were treated with dihydroergotamine mesylate 1.0 mg. IM. Headache severity was rated by subjects using a 4 point scale : 0=None, 1=mild, 2=moderate, 3=severe.
538401|NCT00203242|B1|Baseline|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
538402|NCT00203242|P1|Participant Flow|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
538403|NCT00203242|O1|Outcome|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
538404|NCT00203242|E1|Reported Event|Depacon IV and Depakote|Subjects will be treated with 2 consecutive days of IV Depacon (1000 mg/day) followed by oral Depakote ER (1000 mg/day). Subject continues oral Depakote ER until end of cluster cycle or for a maximum of 6 weeks, which ever comes first.
538405|NCT00203229|B3|Baseline|Total|Total of all reporting groups
538406|NCT00203229|B2|Baseline|Lamotrigine|The intervention type is 'drug' and this arm is the active drug created and supplied by the manufacturers of lamotrigine (Lamictal). This is an anti-seizure medication.
538407|NCT00203229|B1|Baseline|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
538408|NCT00203229|P2|Participant Flow|Lamotrigine|The intervention type is 'drug' and this arm is the active drug supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. This drug is an anti-seizure medication.
538409|NCT00203229|P1|Participant Flow|Placebo|The intervention type is 'drug' and this arm is a placebo pill created and supplied by the manufacturers of lamotrigine (Lamictal) to be exact replicas of the actual drug being studied. The placebo arm is titrated in the exact same manor as the active drug arm.
538625|NCT00201448|O1|Outcome|(Placebo) Hepatitis a|This is the comparator group.
538626|NCT00201448|E2|Reported Event|Towne CMV Vaccine|
538410|NCT00203229|O2|Outcome|Lamotrigine|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
538411|NCT00203229|O1|Outcome|Placebo|Dosing Schedule Morning Evening Daily Total Week 1-2 ---- 50mg 50mg Week 3-4 50mg 50mg 100mg Week 5 100mg 100mg 200mg Week 6 150mg 150mg 300mg Week 7 200mg 200mg 400mg Week 8 (if needed for pain) 200mg 300mg 500mg Week 9 (if needed for pain) 300mg 300mg 600mg Week 10 (if needed for pain) 300mg 400mg 700mg
538412|NCT00203229|E2|Reported Event|Lamotrigine|Subjects who received Lamotrigine
538413|NCT00203229|E1|Reported Event|Placebo|Subjects who received placebo
538414|NCT00203216|B1|Baseline|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
538415|NCT00203216|P1|Participant Flow|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
538416|NCT00203216|O1|Outcome|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
538417|NCT00203216|E1|Reported Event|Levetiracetam/Transcranial Magnetic Stimulation|In this open label trial, all subjects will receive levetiracetam. Subjects may be titrated up to their maximum tolerated dose (MTD) or 3000 mg daily, whichever is lowest. Subjects who cannot tolerate a dose of at least 1000mg per day will be discontinued from the trial. Transmagnetic stimulation will be performed to measure cortical excitability at various intervals during the study.
538418|NCT00203203|B3|Baseline|Total|Total of all reporting groups
538419|NCT00203203|B2|Baseline|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538420|NCT00203203|B1|Baseline|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538421|NCT00203203|P2|Participant Flow|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538422|NCT00203203|P1|Participant Flow|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538423|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538424|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538425|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538426|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538427|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538428|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538429|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538430|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538431|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538432|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538433|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538434|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538435|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538436|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538437|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538438|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538439|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538440|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538441|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538627|NCT00201448|E1|Reported Event|Placebo (Hepatitis A)|
538442|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538443|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538444|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538445|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538446|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538447|NCT00203203|O2|Outcome|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538448|NCT00203203|O1|Outcome|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538449|NCT00203203|E2|Reported Event|Stem Cell Therapy|Subject is randomized to receive intramyocardial injection of stem cells (stem cell therapy) via NOGA mapping.
538450|NCT00203203|E1|Reported Event|Control, Then Stem Cell Therapy|"Subject is randomized to receive a NOGA mapping and no injections at time of active enrollment.~At 6 months, subject is offered stem cell therapy."
538451|NCT00203047|B3|Baseline|Total|Total of all reporting groups
538452|NCT00203047|B2|Baseline|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538453|NCT00203047|B1|Baseline|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538454|NCT00203047|P2|Participant Flow|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538455|NCT00203047|P1|Participant Flow|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538456|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538457|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538458|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538459|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538460|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538461|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538462|NCT00203047|O2|Outcome|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538463|NCT00203047|O1|Outcome|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538464|NCT00203047|E2|Reported Event|GA + Prednisone|Glatiramer acetate (GA) 20mg daily as a subcutaneous injection, plus 1250 mg of prednisone daily.
538465|NCT00203047|E1|Reported Event|GA + Placebo|Glatiramer acetate (GA) 10mg as a subcutaneous injection daily, plus a placebo to mimic prednisone given daily.
538466|NCT00202878|B3|Baseline|Total|Total of all reporting groups
538467|NCT00202878|B2|Baseline|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538468|NCT00202878|B1|Baseline|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538469|NCT00202878|P2|Participant Flow|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538470|NCT00202878|P1|Participant Flow|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538471|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538472|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538473|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538474|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538475|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538476|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538477|NCT00202878|O2|Outcome|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538478|NCT00202878|O1|Outcome|Ezetimibe/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538479|NCT00202878|E2|Reported Event|Simvastatin|One simvastatin 40 mg tablet, one ezetimibe/simvastatin combination 10/40 placebo tablet and one simvastatin 40 mg placebo tablet once per day.
538480|NCT00202878|E1|Reported Event|Ezetimide/Simvastatin|One Ezetimibe 10 mg/simvastatin 40 mg combination tablet and two simvastatin 40 mg placebo tablets once per day.
538481|NCT00202839|B3|Baseline|Total|Total of all reporting groups
538482|NCT00202839|B2|Baseline|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
538628|NCT00201409|B3|Baseline|Total|Total of all reporting groups
538483|NCT00202839|B1|Baseline|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
538484|NCT00202839|P2|Participant Flow|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
538485|NCT00202839|P1|Participant Flow|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
538486|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
538487|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
538488|NCT00202839|O2|Outcome|48-Week Treatment|Genotype 1 HCV subjects treated for a total of 48 weeks: 24 weeks during the pilot treatment program (immediately before randomization) plus 24 weeks during the extended treatment program (immediately after randomization)
538489|NCT00202839|O1|Outcome|24-Week Treatment|Genotype 1 hepatitis C virus [HCV] subjects treated for a total of 24 weeks, during the pilot treatment program (immediately before randomization)
538490|NCT00202839|E2|Reported Event|48-Week Treatment|
538491|NCT00202839|E1|Reported Event|24-Week Treatment|
538492|NCT00202722|B1|Baseline|Women in Labour Given Remifentanil Analgesia|Administration of remifentanil analgesia startet with cervical dilatation > 4 cm
538493|NCT00202722|P1|Participant Flow|Effect and Side Effects of Remifentanil|Analgesic efficacy and side offects of remifentanil during labour and delivery
538494|NCT00202722|O1|Outcome|Satisfaction With Remifentanil Analgesia|Patient satisfaction with remifentanil pain relief by use of questionnaire (within 24-hours after delivery)
538495|NCT00202722|O1|Outcome|Remifentanil|"Pain scores~Satisfaction"
538496|NCT00202722|E1|Reported Event|Maternal Oxygen Desaturation|Oxygen saturation lower than 92% during labour and delivery
538497|NCT00202449|B4|Baseline|Total|Total of all reporting groups
538498|NCT00202449|B3|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538499|NCT00202449|B2|Baseline|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538500|NCT00202449|B1|Baseline|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538501|NCT00202449|P3|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538502|NCT00202449|P2|Participant Flow|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538503|NCT00202449|P1|Participant Flow|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538504|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538505|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538506|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538507|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538508|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538509|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538510|NCT00202449|O3|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538511|NCT00202449|O2|Outcome|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538512|NCT00202449|O1|Outcome|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538513|NCT00202449|E3|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
538514|NCT00202449|E2|Reported Event|Paroxetine|Paroxetine is a Selective Serotonin Reuptake Inhibitor. Dose started and maintained at 20 mg q10A.
538515|NCT00202449|E1|Reported Event|Prazosin|Prazosin is a brain active alpha-1 adrenal receptor antagonist. Dose initiated at an initial dose of 1 mg qhs and titrated up to a maximum dose of 30 mg/day according to weight, age and presence or absence of daytime symptoms.
538516|NCT00201877|B1|Baseline|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538517|NCT00201877|P1|Participant Flow|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538518|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538519|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538629|NCT00201409|B2|Baseline|Placebo Group|Participants will be randomized to receive placebo.
539099|NCT00197392|P1|Participant Flow|Bactiseal EVD|Subjects treated with Bactiseal EVD catheter
538520|NCT00201877|O1|Outcome|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538521|NCT00201877|E1|Reported Event|Velcade and Rituximab|"Rituximab 375 mg/m2 IV day 1 of weeks 4, 5, 7, 8, 10, 11, 13, and 14 prior to Velcade™ administration.~Velcade™ 1.3 mg/m2 IV days 1 and 4 of weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, and 14"
538522|NCT00201864|B1|Baseline|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538523|NCT00201864|P1|Participant Flow|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538524|NCT00201864|O2|Outcome|IGFBP-3|IGFBP-3-insulin-like growth factor-binding
538525|NCT00201864|O1|Outcome|IGF-1|IGF-1-insulin-like growth factor
538526|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538527|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538528|NCT00201864|O1|Outcome|Exemestane and Fulvestrant|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538529|NCT00201864|E1|Reported Event|Single-arm Study|"Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection~Exemestane: 25 mg orally per day~Fulvestrant: 250 mg IM starting on Day 8 and then every 28 days."
538530|NCT00201851|B4|Baseline|Total|Total of all reporting groups
538531|NCT00201851|B3|Baseline|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538532|NCT00201851|B2|Baseline|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538533|NCT00201851|B1|Baseline|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538534|NCT00201851|P3|Participant Flow|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538535|NCT00201851|P2|Participant Flow|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538536|NCT00201851|P1|Participant Flow|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538537|NCT00201851|O3|Outcome|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538538|NCT00201851|O2|Outcome|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538539|NCT00201851|O1|Outcome|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538540|NCT00201851|E3|Reported Event|C- Immediate Surgery - Nonrandomized|"Patient in mid-luteal phase at time of enrollment. Assigned to immediate surgical oophorectomy/mastectomy plus Tamoxifen without randomization~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538596|NCT00201643|P1|Participant Flow|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538541|NCT00201851|E2|Reported Event|B - Immediate Surgery|"Patient assigned to immediate surgical oophorectomy/mastectomy and Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538542|NCT00201851|E1|Reported Event|A - Scheduled Surgery|"Patient scheduled for mid-luteal phase surgical oophorectomy/mastectomy plus Tamoxifen~Tamoxifen: 20 mg po daily x 5 years~Surgery: Oophorectomy: Group A-Surgical oophorectomy and mastectomy in estimated 5 days in mid-luteal phase of menstrual cycle (b, c) Group B-Surgical oophorectomy and mastectomy (1-6 days from randomization)(b, c) Group C-Surgical oophorectomy and mastectomy(1-6 days from registration)(c)"
538543|NCT00201838|B3|Baseline|Total|Total of all reporting groups
538544|NCT00201838|B2|Baseline|Control Arm|Patients received Gemcitabine alone
538545|NCT00201838|B1|Baseline|Interventional Arm|Patients received Etanercept with gemcitabine
538546|NCT00201838|P2|Participant Flow|Control Group|Patients received gemcitabine alone
538547|NCT00201838|P1|Participant Flow|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
538548|NCT00201838|O2|Outcome|Non Responders|"Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
538549|NCT00201838|O1|Outcome|Responders|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
538550|NCT00201838|O2|Outcome|Control Group|gemcitabine alone
538551|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
538552|NCT00201838|O2|Outcome|Control Group|Gemcitabine alone
538553|NCT00201838|O1|Outcome|Experimental Group|Etanercept with gemcitabine
538554|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
538555|NCT00201838|O1|Outcome|Experimental Group|"combination of gemcitabine and etanercept~Gemcitabine: The starting dose will be 1000mg/m2 IV, weekly x 7 with a one week rest followed by weekly x 3 with one week rest for the remainder of treatment.~Etanercept: Etanercept will be self administered subcutaneously by patients with injections 11 prepared by the investigational pharmacy, beginning 7 days prior to the first dose of gemcitabine and continued twice weekly for the duration of the study."
538556|NCT00201838|O2|Outcome|Control Group|Patients received gemcitabine alone
538557|NCT00201838|O1|Outcome|Experimental Group|Patients received etanercept 25mg subcutaneously twice-weekly with gemcitabine
538558|NCT00201838|E2|Reported Event|Control Group|Patients in the control cohort received gemcitabine alone.
538559|NCT00201838|E1|Reported Event|Experimental Group|Patients in the experimental group received etancercept 25 mg subcutaneously twice-weekly with gemcitabine.
538560|NCT00201825|B1|Baseline|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538561|NCT00201825|P1|Participant Flow|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538562|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538563|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538564|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538565|NCT00201825|O1|Outcome|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538566|NCT00201825|E1|Reported Event|Docetaxel and Capecitabine|"Capecitabine: 1250 mg/m2/day in 2 oral daily divided doses of 625 mg/m2 on day 5 of every cycle and continued for 14 days.~Docetaxel: 36 mg/m2 IV weekly for 3 weeks every 4 weeks."
538567|NCT00201773|B1|Baseline|Exemestane & Celecoxib|"Patients will received exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day and instructed to take the drug with food.~Correlative studies"
538568|NCT00201773|P1|Participant Flow|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
538620|NCT00201448|P2|Participant Flow|Towne CMV Vaccine|
538569|NCT00201773|O1|Outcome|Exemestane & Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food.~Correlative studies"
538570|NCT00201773|O2|Outcome|Exemestane|Exemestane (8 weeks) vs. Baseline
538571|NCT00201773|O1|Outcome|Exemestane + Celecoxib|Exemestane + celecoxib (16 weeks) vs. Baseline
538572|NCT00201773|E2|Reported Event|Exemestane + Celecoxib|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
538573|NCT00201773|E1|Reported Event|Exemestane Alone|"Patients will receive exemestane 25 mg orally per day for 8 weeks. Starting in the 9th week, patients will receive celecoxib 400 mg orally twice per day for 8 weeks in addition to exemestane.~Exemestane: 25 mg orally once per day for 16 weeks.~Celecoxib: given orally at two 200 mg capsules (400 mg) twice per day. Patients assigned to receive 400 mg twice per day should be instructed to take the drug with food."
538574|NCT00201734|B3|Baseline|Total|Total of all reporting groups
538575|NCT00201734|B2|Baseline|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538576|NCT00201734|B1|Baseline|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538577|NCT00201734|P2|Participant Flow|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538578|NCT00201734|P1|Participant Flow|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538579|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538580|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538581|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538582|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538583|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538584|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538585|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538586|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538587|NCT00201734|O2|Outcome|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538588|NCT00201734|O1|Outcome|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538589|NCT00201734|O1|Outcome|Phase I Patients|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538590|NCT00201734|E2|Reported Event|Phase II|Phase II trial combination at the recommended doses from the Phase I portion in patients with adenocarcinoma of unknown primary site.
538591|NCT00201734|E1|Reported Event|Phase I|Cycles will be of 4-week duration. Carboplatin was administered on day 1 intravenously for 3 weeks (days 1, 8, 15) and paclitaxel weekly intravenously for 3 weeks on days 1, 8 and 15. Capecitabine was given orally twice daily days 18-21 followed by 1 week rest.
538592|NCT00201643|B3|Baseline|Total|Total of all reporting groups
538593|NCT00201643|B2|Baseline|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538594|NCT00201643|B1|Baseline|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538595|NCT00201643|P2|Participant Flow|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538621|NCT00201448|P1|Participant Flow|Placebo (Hepatitis A)|
538622|NCT00201448|O2|Outcome|Towne Vaccine|"Towne vaccine given at 3000 pfu/subject~Towne CMV Vaccine: Single dose given subcutaneously"
538597|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538598|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538599|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538600|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538601|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538602|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538603|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538604|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538605|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538606|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538607|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538608|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538609|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538610|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538611|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538612|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538613|NCT00201643|O2|Outcome|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538614|NCT00201643|O1|Outcome|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538615|NCT00201643|E2|Reported Event|Placebo (Normal Saline)|"Placebo consisted of quantity sufficient of Normal Saline with preservatives, Benzylalcohol and Benzylbenzoate.~The research subject received 2 doses of pharmacy prepared placebo (2ml normal saline)to conceal administration of dexamethasone or if to conceal betamethasone, 2 doses of Placebo (2ml normal saline) given IM 24 hours apart."
538616|NCT00201643|E1|Reported Event|"Rescue Course of Betamethasone or Dexamethasone"|"Receive 2nd Rescue Course = Study drug (betamethasone or dexamethasone. If Dexamethasone, administered 6 mg IM q 12 hours x 4 doses total. If Betamethasone was used, 2 doses of 12 mg of betamethasone was given intramuscularly (IM) 24 hours apart."
538617|NCT00201448|B3|Baseline|Total|Total of all reporting groups
538618|NCT00201448|B2|Baseline|Towne CMV Vaccine|
538619|NCT00201448|B1|Baseline|Placebo (Hepatitis A)|
538630|NCT00201409|B1|Baseline|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538631|NCT00201409|P2|Participant Flow|Placebo Group|Participants will be randomized to receive placebo.
538632|NCT00201409|P1|Participant Flow|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538633|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
538634|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538635|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
538636|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538637|NCT00201409|O2|Outcome|Placebo Group|Participants will be randomized to receive placebo.
538638|NCT00201409|O1|Outcome|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538639|NCT00201409|E2|Reported Event|Placebo Group|Participants will be randomized to receive placebo.
538640|NCT00201409|E1|Reported Event|GM-CSF Group|Participants will be randomized to receive recombinant human GM-CSF (250 mcg/M2).
538641|NCT00201240|B1|Baseline|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538642|NCT00201240|P1|Participant Flow|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
538643|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538644|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with acute myeloid leukemia (AML) in first or second complete remission
538645|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538646|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538647|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538648|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538649|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538650|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538651|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538652|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538653|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538654|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538655|NCT00201240|O1|Outcome|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538656|NCT00201240|E1|Reported Event|T Cell Depletion|T cell depletion using Miltenyi device for patients with AML in first or second complete remission
538657|NCT00201201|B3|Baseline|Total|Total of all reporting groups
538658|NCT00201201|B2|Baseline|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538659|NCT00201201|B1|Baseline|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program."
538660|NCT00201201|P2|Participant Flow|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538661|NCT00201201|P1|Participant Flow|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538662|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538663|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538689|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
538690|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
538664|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538665|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538666|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538667|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538668|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538669|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538670|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538671|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538672|NCT00201201|O2|Outcome|Control|"Control:~Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The control group met with the APRN after entering their data on the PEP-NG but did not receive a targeted and tailored education intervention."
538673|NCT00201201|O1|Outcome|Education Intervention|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension were randomized to usual care and education (intervention)groups. Both groups entered medication taking behaviors on the PEP-NG and answered questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The education (intervention) group received a tailored education program generated by the PEP-NG software and reinforced by the APRN."
538674|NCT00201201|E2|Reported Event|Control|Control group without education intervention.
538675|NCT00201201|E1|Reported Event|Education|"PEP education intervention~Personal Education Program - Next Generation (PEP-NG) : Adults aged 60 and over with hypertension will be randomized to usual care and intervention groups. Both groups will enter medication taking behaviors on the PEP-NG and answer questions related to knowledge and self-efficacy regarding adverse self-medication behaviors. The intervention group will receive a tailored education program."
538676|NCT00201123|B4|Baseline|Total|Total of all reporting groups
538677|NCT00201123|B3|Baseline|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
538678|NCT00201123|B2|Baseline|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
538679|NCT00201123|B1|Baseline|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
538680|NCT00201123|P3|Participant Flow|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
538681|NCT00201123|P2|Participant Flow|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
538682|NCT00201123|P1|Participant Flow|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
538683|NCT00201123|O3|Outcome|Subcutaneous rlFN-y|
538684|NCT00201123|O2|Outcome|Nebulized rlFN-y|
538685|NCT00201123|O1|Outcome|DOTS|
538686|NCT00201123|O3|Outcome|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Participants will receive subcutaneous interferon-gamma."
538687|NCT00201123|O2|Outcome|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
538688|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
538691|NCT00201123|O1|Outcome|DOTS Control Group|"IRPE Anti-Tuberculous Therapy~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
538692|NCT00201123|E3|Reported Event|Subcutaneous Interferon Gamma for TB|"Subcutaneous Interferon-Gamma~Subcutaneous Interferon-Gamma: Partcipants will receive subcutaneous interferon-gamma."
538693|NCT00201123|E2|Reported Event|Aerosol Interferon Gamma for TB|"Aerosol Interferon-Gamma~Aerosol Interferon-Gamma: Participants will receive aerosol interferon-gamma."
538694|NCT00201123|E1|Reported Event|DOTS Control Group|"DOTS Control Group~IRPE Anti-Tuberculous Therapy: Participants will receive IRPE anti-tuberculous therapy."
538695|NCT00201006|B4|Baseline|Total|Total of all reporting groups
538696|NCT00201006|B3|Baseline|Mail Contact|26 biweekly newsletters with weight management advice
538697|NCT00201006|B2|Baseline|Telephone Counseling|26 biweekly telephone counseling sessions
538698|NCT00201006|B1|Baseline|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
538699|NCT00201006|P3|Participant Flow|Mail Contact|26 biweekly newsletters with weight management advice
538700|NCT00201006|P2|Participant Flow|Telephone Counseling|26 biweekly telephone counseling sessions
538701|NCT00201006|P1|Participant Flow|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
538702|NCT00201006|O3|Outcome|Mail Contact|26 biweekly newsletters with weight management advice
538703|NCT00201006|O2|Outcome|Telephone Counseling|26 biweekly telephone counseling sessions
538704|NCT00201006|O1|Outcome|Face-to-face Counseling|26 biweekly face-to-face group counseling sessions
538705|NCT00201006|E3|Reported Event|Mail|received by mail 26 biweekly newsletters with weight management information
538706|NCT00201006|E2|Reported Event|Telephone|received 26 biweekly individual telephone counseling sessions
538707|NCT00201006|E1|Reported Event|Face-to-face|received 26 biweekly office-based, face-to-face group counseling sessions
538708|NCT00200967|B3|Baseline|Total|Total of all reporting groups
538709|NCT00200967|B2|Baseline|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538710|NCT00200967|B1|Baseline|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538711|NCT00200967|P2|Participant Flow|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538712|NCT00200967|P1|Participant Flow|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538713|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538714|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538715|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538716|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538717|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538718|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538719|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538720|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538721|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538722|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538723|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538758|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538724|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538725|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538726|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538727|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538728|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538729|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538730|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538731|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538732|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538733|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538734|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538735|NCT00200967|O2|Outcome|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538736|NCT00200967|O1|Outcome|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538737|NCT00200967|E2|Reported Event|B16 Gly/Gly|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538738|NCT00200967|E1|Reported Event|B16 Arg/Arg|B16 Arg/Arg genotype Sequence 1: inhaled salmeterol + inhaled beclomethasone HFA, followed by inhaled placebo salmeterol + inhaled beclomethasone HFA Sequence 2: inhaled placebo salmeterol + inhaled beclomethasone HFA, followed by inhaled salmeterol + inhaled beclomethasone HFA
538739|NCT00200785|B3|Baseline|Total|Total of all reporting groups
538740|NCT00200785|B2|Baseline|Garlic Powder: No Allicin|garlic powder in boiling water
538741|NCT00200785|B1|Baseline|Garlic Powder: High Allicin|garlic powder in ambient water
538742|NCT00200785|P2|Participant Flow|Garlic Powder: No Allicin|garlic powder in boiling water
538743|NCT00200785|P1|Participant Flow|Garlic Powder: High Allicin|garlic powder in ambient water
538744|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
538745|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
538746|NCT00200785|O2|Outcome|Garlic Powder: No Allicin|garlic powder in boiling water
538747|NCT00200785|O1|Outcome|Garlic Powder: High Allicin|garlic powder in ambient water
538748|NCT00200785|E2|Reported Event|Garlic Powder: No Allicin|garlic powder in boiling water
538749|NCT00200785|E1|Reported Event|Garlic Powder: High Allicin|garlic powder in ambient water
538750|NCT00200356|B3|Baseline|Total|Total of all reporting groups
538751|NCT00200356|B2|Baseline|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538752|NCT00200356|B1|Baseline|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538753|NCT00200356|P2|Participant Flow|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538754|NCT00200356|P1|Participant Flow|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538755|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538756|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538757|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
543744|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
538759|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538760|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538761|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538762|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538763|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538764|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538765|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538766|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538767|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538768|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538769|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538770|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538771|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538772|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538773|NCT00200356|O2|Outcome|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538774|NCT00200356|O1|Outcome|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538775|NCT00200356|E2|Reported Event|Ozagrel|Sodium Ozagrel, at 80 mg, is intravenously administered by drip over 2 hours b.i.d., in the morning and the evening.
538776|NCT00200356|E1|Reported Event|Edaravone|Edaravone, at 30 mg, is intravenously administered by drip over 30 minutes b.i.d., in the morning and the evening.
538777|NCT00200343|B4|Baseline|Total|Total of all reporting groups
538778|NCT00200343|B3|Baseline|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538779|NCT00200343|B2|Baseline|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538780|NCT00200343|B1|Baseline|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538781|NCT00200343|P3|Participant Flow|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538782|NCT00200343|P2|Participant Flow|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538783|NCT00200343|P1|Participant Flow|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538784|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538785|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538786|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538787|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538788|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538789|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538790|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538791|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538792|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538793|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538794|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538795|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538796|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538797|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538798|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538799|NCT00200343|O3|Outcome|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538800|NCT00200343|O2|Outcome|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538801|NCT00200343|O1|Outcome|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538802|NCT00200343|E3|Reported Event|900mg / Day|ursodeoxycholic acid, 900mg/day, three times a day at meals
538803|NCT00200343|E2|Reported Event|600mg / Day|ursodeoxycholic acid, 600mg/day, three times a day at meals
538804|NCT00200343|E1|Reported Event|150mg / Day|ursodeoxycholic acid, 150mg/day, three times a day at meals
538805|NCT00200057|B1|Baseline|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538806|NCT00200057|P1|Participant Flow|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538807|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538808|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538809|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538810|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538811|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538812|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538813|NCT00200057|O1|Outcome|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538814|NCT00200057|E1|Reported Event|Implanted Subjects|Subjects implanted with Sacral Nerve Stimulation (SNS) device.
538815|NCT00199914|B3|Baseline|Total|Total of all reporting groups
538816|NCT00199914|B2|Baseline|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538817|NCT00199914|B1|Baseline|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538818|NCT00199914|P2|Participant Flow|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538819|NCT00199914|P1|Participant Flow|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538820|NCT00199914|O2|Outcome|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538821|NCT00199914|O1|Outcome|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538822|NCT00199914|E2|Reported Event|Control|continuous sham Shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538823|NCT00199914|E1|Reported Event|Shortwave Diathermy|continuous shortwave diathermy, 20 min/session, 3 sessions/week for 3 weeks
538824|NCT00199381|B1|Baseline|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
538825|NCT00199381|P1|Participant Flow|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
538826|NCT00199381|O1|Outcome|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
538827|NCT00199381|E1|Reported Event|Single Arm|Treatment with oral istradefylline (KW-6002) 20 or 40 mg once daily.
538828|NCT00198822|B4|Baseline|Total|Total of all reporting groups
538829|NCT00198822|B3|Baseline|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538830|NCT00198822|B2|Baseline|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538831|NCT00198822|B1|Baseline|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538832|NCT00198822|P3|Participant Flow|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538833|NCT00198822|P2|Participant Flow|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538834|NCT00198822|P1|Participant Flow|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538835|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538836|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538837|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538838|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538839|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538840|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538841|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538842|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538843|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538844|NCT00198822|O3|Outcome|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538845|NCT00198822|O2|Outcome|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538846|NCT00198822|O1|Outcome|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538847|NCT00198822|E3|Reported Event|3 Beta-Carotene Group|Weekly oral supplement with 42 mg of all-trans beta-carotene from early pregnancy through 12 weeks following termination of pregnancy
538848|NCT00198822|E2|Reported Event|2 Vitamin A Supplement|Weekly oral supplement with 7000 micrograms of retinol equivalents from early pregnancy through 12 weeks following termination of pregnancy
538849|NCT00198822|E1|Reported Event|1 Placebo Control|Weekly oral supplement with placebo from early pregnancy through 12 weeks following termination of pregnancy
538850|NCT00197119|B3|Baseline|Total|Total of all reporting groups
538851|NCT00197119|B2|Baseline|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538852|NCT00197119|B1|Baseline|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538853|NCT00197119|P2|Participant Flow|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538854|NCT00197119|P1|Participant Flow|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538855|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538856|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538857|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538858|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538859|NCT00197119|O2|Outcome|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538860|NCT00197119|O1|Outcome|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538861|NCT00197119|E2|Reported Event|Group Twinrix Adult|Subjects received Twinrix™ Adult (720/20) in a 0, 6 month schedule in the primary study.
538862|NCT00197119|E1|Reported Event|Group Twinrix Junior|Subjects received Twinrix™ Junior (360/10) in a 0, 1, 6 month schedule in the primary study.
538863|NCT00197106|B3|Baseline|Total|Total of all reporting groups
538864|NCT00197106|B2|Baseline|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538865|NCT00197106|B1|Baseline|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538866|NCT00197106|P3|Participant Flow|FP 200 Mcg|FP 200 mcg (delivered as two 100 mcg puffs) BID via DISKUS inhaler
538867|NCT00197106|P2|Participant Flow|Salmeterol/FP 50/100 Mcg Plus Placebo|One puff Salmeterol/FP 50/100 mcg plus one puff placebo (matching one puff of FP in the 200 mcg group) BID via DISKUS inhaler
538868|NCT00197106|P1|Participant Flow|Fluticasone Propionate (FP) 100 Mcg|Fluticasone propionate (FP) 100 mcg (micrograms) twice daily (BID) via DISKUS inhaler
538869|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538870|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538871|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538872|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538873|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538874|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538875|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538876|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538877|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538878|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538879|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538880|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538881|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538882|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538883|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538884|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538885|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538886|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538887|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538888|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538889|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538890|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538891|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538892|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538893|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538894|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538895|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538896|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538897|NCT00197106|O2|Outcome|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538898|NCT00197106|O1|Outcome|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538899|NCT00197106|E2|Reported Event|FP 200 Mcg|FP 200 mcg BID via DISKUS inhaler
538900|NCT00197106|E1|Reported Event|Salmeterol/FP 50/100 Mcg Plus Placebo|Salmeterol/FP 50/100 mcg plus placebo BID via DISKUS inhaler
538901|NCT00198133|B3|Baseline|Total|Total of all reporting groups
538902|NCT00198133|B2|Baseline|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538903|NCT00198133|B1|Baseline|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538904|NCT00198133|P2|Participant Flow|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538905|NCT00198133|P1|Participant Flow|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538906|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538907|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538908|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538909|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538910|NCT00198133|O2|Outcome|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538911|NCT00198133|O1|Outcome|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538912|NCT00198133|E2|Reported Event|Thymic Carcinoma|Patients with Thymic Carcinoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538913|NCT00198133|E1|Reported Event|Thymoma|Patients with Thymoma who received Pemetrexed 500 mg/m2 IV every 3 weeks
538914|NCT00198081|B3|Baseline|Total|Total of all reporting groups
538915|NCT00198081|B2|Baseline|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
538916|NCT00198081|B1|Baseline|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538917|NCT00198081|P2|Participant Flow|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
538918|NCT00198081|P1|Participant Flow|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538919|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538920|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538921|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538922|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538923|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538924|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538925|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538926|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538927|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538928|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538929|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538930|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538931|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538932|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538933|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538934|NCT00198081|O2|Outcome|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
538935|NCT00198081|O1|Outcome|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538936|NCT00198081|O5|Outcome|Surgical Candidate 6 Months|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538937|NCT00198081|O4|Outcome|Surgical Candidate 4 Weeks|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538938|NCT00198081|O3|Outcome|Surgical Candidate One Week|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538939|NCT00198081|O2|Outcome|Surgery Candidate Surgery|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538940|NCT00198081|O1|Outcome|Surgical Candidate Baseline|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538941|NCT00198081|E2|Reported Event|Medical Candidate|"COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP~COX-2 Inhibitor for 6 months prior to follow-up EUS or ERCP: 400 mg BID for 6 months prior to follow-up EUS or ERCP"
538942|NCT00198081|E1|Reported Event|Surgical Candidate|"COX-2 Inhibitor 6-8 weeks prior to surgery~COX-2 Inhibitor 6-8 weeks prior to surgery: 400 mg BID 6-8 weeks prior to surgery"
538943|NCT00198029|B1|Baseline|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
538944|NCT00198029|P1|Participant Flow|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
538945|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
538946|NCT00198029|O1|Outcome|Synvisc Group|Thirty-two patients were injected once weekly for three weeks with Hylan G-F 20 and followed for 6 months post injections.
538947|NCT00198029|E1|Reported Event|Open Label Group|Thirty-two patients were injected over ten months with Synvisc and followed for 6 months post injections.
538948|NCT00197028|B3|Baseline|Total|Total of all reporting groups
538949|NCT00197028|B2|Baseline|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538950|NCT00197028|B1|Baseline|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
539017|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
538951|NCT00197028|P2|Participant Flow|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538952|NCT00197028|P1|Participant Flow|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538953|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538954|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538955|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538956|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538957|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538958|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538959|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538960|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538961|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538962|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538963|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538964|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538965|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538966|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538967|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
539018|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539098|NCT00197392|P2|Participant Flow|Conventional EVD Catheter|Subjects treated with Standard EVD catheter
538968|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538969|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538970|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538971|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538972|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538973|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538974|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538975|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538976|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538977|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538978|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538979|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538980|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538981|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538982|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538983|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538984|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
539019|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
543745|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
538985|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538986|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538987|NCT00197028|O2|Outcome|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538988|NCT00197028|O1|Outcome|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538989|NCT00197028|E2|Reported Event|Engerix-B Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of Engerix-B® vaccine at days 14, 44 and 74 and a 3-dose of TETRActHib™ vaccine at days 0, 30 and 60. The Engerix-B® vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538990|NCT00197028|E1|Reported Event|RTS,S/AS02D Group|Subjects aged between 6 and 12 weeks at the time of first vaccination received by intramuscular injection a 3-dose vaccination course of RTS,S/AS02D at days 14, 44 and 74 and a 3-dose vaccination course of TETRActHib™ vaccine at days 0, 30 and 60. The RTS,S/AS02D vaccine was administered in the left anterolateral thigh, and the TETRActHib™ vaccine in the right anterolateral thigh.
538991|NCT00197015|B4|Baseline|Total|Total of all reporting groups
538992|NCT00197015|B3|Baseline|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
538993|NCT00197015|B2|Baseline|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
538994|NCT00197015|B1|Baseline|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
538995|NCT00197015|P3|Participant Flow|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
538996|NCT00197015|P2|Participant Flow|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
538997|NCT00197015|P1|Participant Flow|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
538998|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
538999|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539000|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539001|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539002|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539003|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539004|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539005|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539006|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539007|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539008|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539009|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539010|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539011|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539012|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539013|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539014|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539015|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539016|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539020|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539021|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539022|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539023|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539024|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539025|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539026|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539027|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539028|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539029|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539030|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539031|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539032|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539033|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539034|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539035|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539036|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539037|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539038|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539039|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539040|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539041|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539042|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539043|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539044|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539045|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539046|NCT00197015|O3|Outcome|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539047|NCT00197015|O2|Outcome|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539048|NCT00197015|O1|Outcome|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539049|NCT00197015|E3|Reported Event|HAV+MMR+V Group|Subjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
539050|NCT00197015|E2|Reported Event|MMR+V→HAV Group|Subjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
539051|NCT00197015|E1|Reported Event|HAV Group|Subjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
539052|NCT00196937|B4|Baseline|Total|Total of all reporting groups
539053|NCT00196937|B3|Baseline|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539054|NCT00196937|B2|Baseline|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539055|NCT00196937|B1|Baseline|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539056|NCT00196937|P3|Participant Flow|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539057|NCT00196937|P2|Participant Flow|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539058|NCT00196937|P1|Participant Flow|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539097|NCT00197392|B1|Baseline|Bactiseal EVD|
539059|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539060|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539061|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539062|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539063|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539064|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539065|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539066|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539067|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539068|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539069|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539070|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539071|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539072|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539073|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539074|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539075|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539076|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539077|NCT00196937|O3|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
539078|NCT00196937|O2|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule
539079|NCT00196937|O1|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
539080|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539081|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539082|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539083|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
539084|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
539085|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
539086|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539087|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539088|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539089|NCT00196937|O3|Outcome|Cervarix (46-55 Years) Group|Women of 46-55 years of age received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule
539090|NCT00196937|O2|Outcome|Cervarix (26-45 Years) Group|Women of 26-45 years of age received 3 doses of Cervarix™ (HPV vaccine)administered according to a 0, 1, 6-month schedule
539091|NCT00196937|O1|Outcome|Cervarix (15-25 Years) Group|Women of 15-25 years of age received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine)administered according to a 0, 1, 6-month schedule
539092|NCT00196937|E3|Reported Event|Cervarix (46-55 Years) Group|Women aged 46 to 55 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539093|NCT00196937|E2|Reported Event|Cervarix (26-45 Years) Group|Women aged 26 to 45 years received 3 doses of Cervarix™ (HPV vaccine) administered according to a 0, 1, 6-month schedule.
539094|NCT00196937|E1|Reported Event|Cervarix (15-25 Years) Group|Women aged 15 to 25 years received 3 doses of Cervarix™ (human papillomavirus [HPV] vaccine) administered according to a 0, 1, 6-month schedule.
539095|NCT00197392|B3|Baseline|Total|Total of all reporting groups
539096|NCT00197392|B2|Baseline|Standard EVD|
539100|NCT00197392|O2|Outcome|Standard EVD|Subjects implanted with Standard EVD catheters.
539101|NCT00197392|O1|Outcome|Bactiseal EVD|Subjects implanted with Bactiseal EVD catheters.
539102|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
539103|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
539104|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with a standard EVD catheter
539105|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with the Bactiseal EVD Catheter
539106|NCT00197392|O2|Outcome|Standrad EVD Catheter|Subjects implanted with standard EVD catheter
539107|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
539108|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects treated with standard EVD catheter
539109|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects treated with Bactiseal EVD Catheter
539110|NCT00197392|O1|Outcome|Bactiseal EVD Catheter and Standard EVD Cathter|Patients implanted with Bactiseal EVD Catheter or Standard EVD Catheter.
539111|NCT00197392|O2|Outcome|Standard EVD Catheter|Subjects implanted with standard EVD catheter
539112|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Subjects implanted with Bactiseal EVD Catheter
539113|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
539114|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
539115|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with standard EVD catheter
539116|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
539117|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients implanted with Standard EVD Catheter
539118|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients implanted with Bactiseal EVD Catheter
539119|NCT00197392|O2|Outcome|Standard EVD Catheter|Patient treated with Standard EVD Catheter
539120|NCT00197392|O1|Outcome|Bactiseal - EVD Catheter|Patients treated with Bactiseal EVD catheter
539121|NCT00197392|O2|Outcome|Standard EVD Catheter|Patients treated with standard EVD catheter.
539122|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
539123|NCT00197392|O2|Outcome|Standard EVD Cathter|Patients treated with Standard EVD Catheter
539124|NCT00197392|O1|Outcome|Bactiseal EVD Catheter|Patients treated with Codman Bactiseal EVD Catheter
539125|NCT00197392|E2|Reported Event|Bactiseal EVD|Subjects with Bactiseal EVD
539126|NCT00197392|E1|Reported Event|Standard EVD|Subjects with standard EVD
539127|NCT00197236|B4|Baseline|Total|Total of all reporting groups
539128|NCT00197236|B3|Baseline|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539129|NCT00197236|B2|Baseline|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539130|NCT00197236|B1|Baseline|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539131|NCT00197236|P3|Participant Flow|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539132|NCT00197236|P2|Participant Flow|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539133|NCT00197236|P1|Participant Flow|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539134|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539135|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539136|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539137|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539138|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539139|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539140|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539141|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539142|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539143|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539144|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539145|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539146|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539147|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539148|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539149|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539150|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539151|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539152|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539153|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539154|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539155|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539156|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539157|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539158|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539159|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539160|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539161|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539162|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539163|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539164|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539165|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539166|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539167|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539168|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539169|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539170|NCT00197236|O3|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539171|NCT00197236|O2|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539172|NCT00197236|O1|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539173|NCT00197236|O3|Outcome|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539174|NCT00197236|O2|Outcome|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539175|NCT00197236|O1|Outcome|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539176|NCT00197236|E3|Reported Event|Infanrix + ActHIB→Havrix Group|Subjects received Infanrix co-administered with ActHIB at Day 0, followed by one dose of Havix at Day 30 and a second dose of Havrix at Month 7-10.
539177|NCT00197236|E2|Reported Event|Havrix + Infanrix + ActHIB Group|Subjects received one dose of Havrix co-administered with Infanrix and ActHIB vaccines at Day 0 followed by a second dose of Havrix at Month 6-9.
539178|NCT00197236|E1|Reported Event|Havrix Group|Subjects received one dose of Havrix at Day 0 followed by a second dose of Havrix at Month 6-9.
539179|NCT00197184|B3|Baseline|Total|Total of all reporting groups
539180|NCT00197184|B2|Baseline|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539181|NCT00197184|B1|Baseline|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539182|NCT00197184|P2|Participant Flow|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539183|NCT00197184|P1|Participant Flow|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539184|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539185|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539186|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539187|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539188|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539189|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539190|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539191|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539192|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539193|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539194|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539195|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539196|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539197|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539198|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539199|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539200|NCT00197184|O2|Outcome|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539201|NCT00197184|O1|Outcome|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539202|NCT00197184|E2|Reported Event|Twinrix Junior|Subjects previously received 3 doses of combined hepatitis A / hepatitis B vaccine (junior formulation).
539203|NCT00197184|E1|Reported Event|Twinrix Adult|Subjects previously received 2 doses of combined hepatitis A / hepatitis B vaccine (adult formulation).
539204|NCT00196716|B1|Baseline|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539205|NCT00196716|P1|Participant Flow|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539206|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539207|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539208|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539209|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539210|NCT00196716|O1|Outcome|Fabrazyme|Open-label study. Patients received 1.0 mg/kg Fabrazyme every two weeks for approximately six months followed by 0.3 mg/kg Fabrazyme every two weeks for approximately 18 months.
539211|NCT00196716|E3|Reported Event|Total|
539212|NCT00196716|E2|Reported Event|0.3 mg/kg Fabrazyme|0.3 mg/kg Fabrazyme, Week 24 to Week 96.
539213|NCT00196716|E1|Reported Event|1.0 mg/kg Fabrazyme|1.0 mg/kg Fabrazyme, Week 0 to Week 24.
539214|NCT00196326|B1|Baseline|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539215|NCT00196326|P1|Participant Flow|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539216|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539217|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539218|NCT00196326|O1|Outcome|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539219|NCT00196326|E1|Reported Event|DR-1011|Participants were instructed to take, by mouth, one tablet daily for four 91-day cycles.
539220|NCT00196313|B3|Baseline|Total|Total of all reporting groups
539221|NCT00196313|B2|Baseline|Placebo|Placebo, 1 tablet daily
539222|NCT00196313|B1|Baseline|Seasonique|"Seasonique~, 1 tablet daily"
539223|NCT00196313|P2|Participant Flow|Placebo|Placebo, 1 tablet daily
539224|NCT00196313|P1|Participant Flow|Seasonique|"Seasonique~, 1 tablet daily"
539225|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
539226|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
539227|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
539228|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
539229|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
539230|NCT00196313|O1|Outcome|Seasonique|Seasonique, 1 tablet daily
539231|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
539232|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
539233|NCT00196313|O2|Outcome|Placebo|Placebo, 1 tablet daily
539234|NCT00196313|O1|Outcome|Seasonique|"Seasonique~, 1 tablet daily"
539235|NCT00196313|E2|Reported Event|Placebo|Placebo, 1 tablet daily
539236|NCT00196313|E1|Reported Event|Seasonique|"Seasonique~, 1 tablet daily"
539237|NCT00196196|B1|Baseline|Codman VPV System|
539238|NCT00196196|P1|Participant Flow|Codman VPV System|
539239|NCT00196196|O1|Outcome|Codman VPV System|
539240|NCT00196196|O1|Outcome|Codman VPV System|
539241|NCT00196196|E1|Reported Event|Codman VPV System|
539242|NCT00196105|B4|Baseline|Total|Total of all reporting groups
539243|NCT00196105|B3|Baseline|10 mm Wallstent|10 mm Stainless Steel Wallstent
539244|NCT00196105|B2|Baseline|10 mm Zilver|10 mm Nitinol Zilver Stent
539245|NCT00196105|B1|Baseline|6 mm Zilver|6 mm Nitinol Zilver Stent
539246|NCT00196105|P3|Participant Flow|10 mm Wallstent|10 mm Stainless Steel Wallstent
539247|NCT00196105|P2|Participant Flow|10 mm Zilver|10 mm Nitinol Zilver Stent
539248|NCT00196105|P1|Participant Flow|6 mm Zilver|6 mm Nitinol Zilver Stent
539249|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
539250|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
539251|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
539252|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
539253|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
539254|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
539255|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
539256|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
539257|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
539258|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
539259|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
539260|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
539261|NCT00196105|O3|Outcome|10 mm Wallstent|10 mm Stainless Steel Wallstent
539262|NCT00196105|O2|Outcome|10 mm Zilver|10 mm Nitinol Zilver Stent
539263|NCT00196105|O1|Outcome|6 mm Zilver|6 mm Nitinol Zilver Stent
539264|NCT00196105|E3|Reported Event|10 mm Wallstent|10 mm Stainless Steel Wallstent
539265|NCT00196105|E2|Reported Event|10 mm Zilver|10 mm Nitinol Zilver Stent
539266|NCT00196105|E1|Reported Event|6 mm Zilver|6 mm Nitinol Zilver Stent
539267|NCT00195819|B1|Baseline|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539268|NCT00195819|P2|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
539269|NCT00195819|P1|Participant Flow|Placebo 40 mg Every Other Week (Eow), Subcutaneous (SC)|
539270|NCT00195819|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
539271|NCT00195819|O2|Outcome|Placebo|(Week 52 - placebo plus up to 40 weeks of adalimumab)
539272|NCT00195819|O1|Outcome|Adalimumab Exposure|Adalimumab 40 mg every other week (eow)
539273|NCT00195819|O2|Outcome|Placebo|(Week 52 - Placebo plus up to 40 weeks adalimumab)
539274|NCT00195819|O1|Outcome|Adalimumab|Adalimumab every other week (eow)
539275|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539276|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539277|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539278|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539279|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539280|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539281|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539282|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539283|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539284|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539285|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539286|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539287|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539288|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539289|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539290|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539291|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539292|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539293|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539294|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539295|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539296|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539297|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539298|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539299|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539300|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539301|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539302|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539303|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539304|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539305|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539306|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539307|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539308|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539309|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539310|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539311|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539312|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539313|NCT00195819|O1|Outcome|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539314|NCT00195819|O1|Outcome|Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
539315|NCT00195819|O2|Outcome|Placebo|40 mg every other week, subcutaneous
539316|NCT00195819|O1|Outcome|Adalimumab|40 mg every other week, subcutaneous
539317|NCT00195819|E1|Reported Event|Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
539318|NCT00195715|B1|Baseline|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539319|NCT00195715|P1|Participant Flow|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539320|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539321|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539322|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539323|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539324|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539325|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539326|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539327|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539328|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539329|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539330|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539331|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539332|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539333|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539334|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539335|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539336|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539337|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539338|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539339|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539340|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539341|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539342|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539343|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539344|NCT00195715|O1|Outcome|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539345|NCT00195715|E1|Reported Event|Open-label Adalimumab|40 mg by subcutaneous injection every other week or every week
539346|NCT00195702|B4|Baseline|Total|Total of all reporting groups
539347|NCT00195702|B3|Baseline|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539348|NCT00195702|B2|Baseline|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539349|NCT00195702|B1|Baseline|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539350|NCT00195702|P6|Participant Flow|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
539351|NCT00195702|P5|Participant Flow|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
539352|NCT00195702|P4|Participant Flow|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg weekly (ew) during the double-blind (DB) phase, then received adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase. Subjects received concomitant methotrexate (MTX) during both phases of the study.
539353|NCT00195702|P3|Participant Flow|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539354|NCT00195702|P2|Participant Flow|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539355|NCT00195702|P1|Participant Flow|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539356|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
539357|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
539358|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
539359|NCT00195702|O3|Outcome|DB Placebo ew/OL Adalimumab 40 mg Eow|Subjects received placebo every week (ew) during the double-blind (DB) phase, followed by adalimumab 40 mg every other week (eow) during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
539360|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow/OL Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) during the double-blind (DB) phase, followed by adalimumab 40 mg eow during the open-label (OL) extension phase, along with concomitant methotrexate (MTX).
539361|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew/OL Adalimumab 40 mg Eow|Subjects received adalimumab 20 mg every week (ew) during the double-blind (DB) phase, followed by adalimumab every other week (eow) during the open-label (OL) extension, along with concomitant methotrexate (MTX).
539362|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539363|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539364|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539365|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539366|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539367|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539368|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539369|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539370|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539371|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539372|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539373|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539374|NCT00195702|O1|Outcome|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539375|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539376|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539377|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539378|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539379|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539380|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539381|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539382|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539383|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539384|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539385|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539386|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539387|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539388|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539389|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539390|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539391|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539392|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539393|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539394|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539395|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539396|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539397|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539398|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539399|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539400|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539401|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539402|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539403|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539404|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539405|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539406|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539407|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539408|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539409|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539410|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539411|NCT00195702|O3|Outcome|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539412|NCT00195702|O2|Outcome|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539413|NCT00195702|O1|Outcome|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539414|NCT00195702|E4|Reported Event|Any Adalimumab Through Year 10|Subjects received at least 1 dose of adalimumab over the 10-year duration of the study (the intent-to-treat population, N = 553).
539415|NCT00195702|E3|Reported Event|DB Placebo ew|Subjects received placebo every week and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539416|NCT00195702|E2|Reported Event|DB Adalimumab 40 mg Eow|Subjects received adalimumab 40 mg every other week (eow) and concomitant methotrexate (MTX) during the 52-week double-blind phase.
539417|NCT00195702|E1|Reported Event|DB Adalimumab 20 mg ew|Subjects received adalimumab 20 mg every week (ew) and concomitant methotrexate (MTX) during the 52-week double-blind treatment phase.
539418|NCT00195676|B1|Baseline|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
539419|NCT00195676|P1|Participant Flow|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
539420|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Not Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had not relapsed (i.e., PGA not greater than or equal to 3) in Period W after adalimumab therapy was withdrawn.
539421|NCT00195676|O1|Outcome|Period R mITT Population Relapsed in Period W|A subset of the Period R modified Intent-to-Treat (mITT) population who had relapsed in Period W after adalimumab therapy was withdrawn.
539422|NCT00195676|O1|Outcome|Period W Modified Intent-to-treat Population|Participants from Period O who entered Period W with a PGA of 0 or 1 for the last 2 consecutive visits of Period O, at least 12 weeks apart, and received adalimumab 40 mg every other week for at least 12 weeks prior to entering Period W.
539423|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
539424|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
539425|NCT00195676|O1|Outcome|Period R Modified Intent-to-Treat Population|Participants of the Period W Modified Intent-to-Treat(mITT) Population who received at least one retreatment dose of adalimumab 40 mg every other week in Period R. The Period W mITT Population had entered Period W from Period O with stable psoriasis control [i.e., had a PGA of 0 or 1 at the last 2 consecutive visits in Period O, at least 12 weeks apart, and were on adalimumab 40 mg every other week for the last 12 weeks of Period O).
540050|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
539426|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
539427|NCT00195676|O1|Outcome|Period O Adalimumab EOW Treatment Population|Participants in the All Adalimumab Treatment population who initiated treatment with an adalimumab 40 mg every other week (eow) injection or placebo injection in a prior study.
539428|NCT00195676|E1|Reported Event|All Adalimumab Treatment|All participants in the study who received at least one dose of adalimumab. In this study, participants were treated with adalimumab 40 mg every other week (eow) or 40 mg every week by subcutaneous injection (SC) in Period O and then were retreated with open-label adalimumab 40 mg eow SC (after an 80 mg initial dose) in Period R after withdrawal from adalimumab treatment in Period W.
539429|NCT00195663|B4|Baseline|Total|Total of all reporting groups
539430|NCT00195663|B3|Baseline|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539431|NCT00195663|B2|Baseline|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
539432|NCT00195663|B1|Baseline|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539433|NCT00195663|P3|Participant Flow|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539434|NCT00195663|P2|Participant Flow|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
539435|NCT00195663|P1|Participant Flow|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539436|NCT00195663|O2|Outcome|Adalimumab: HAQ Decrease ≥ 0.5|Participants with a decrease of least 0.5 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
539437|NCT00195663|O1|Outcome|Adalimumab: HAQ Decrease ≥ 0.22|Participants with a decrease of least 0.22 in HAQ from baseline, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
539438|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539439|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539440|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
539441|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539442|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539443|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
539444|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539445|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539446|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase and then adalimumab 40 mg every other week for up to 8 years in the open-label extension.
539526|NCT00195663|E2|Reported Event|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539447|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase. Participants received adalimumab 40 mg every other week for up to 8 years in the open-label extension phase.
539448|NCT00195663|O2|Outcome|Adalimumab: DAS28 < 3.2|Participants with a DAS28 score less than 3.2, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
539449|NCT00195663|O1|Outcome|Adalimumab: DAS28 < 2.6|Participants with a DAS28 score less than 2.6, who received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase and adalimumab 40 mg every other week during the 8-year open-label phase.
539450|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539451|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539452|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539453|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539454|NCT00195663|O1|Outcome|Any Adalimumab|Participants received either methotrexate (MTX), adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.
539455|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539456|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539457|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539458|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539459|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539460|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539461|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539462|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539463|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539464|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539465|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539466|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539467|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539468|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539469|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539470|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539471|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539472|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539473|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539474|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539475|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539476|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539477|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539478|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539479|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539480|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539481|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539482|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539483|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539484|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539485|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539486|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539487|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539488|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539489|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539490|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539491|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539492|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539493|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539494|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539495|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539496|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539497|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539498|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539499|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539500|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539501|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539502|NCT00195663|O1|Outcome|Methotrexate Weekly|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539503|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539504|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539505|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539506|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539507|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539508|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539509|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539510|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539511|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539512|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539513|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539514|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539515|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539516|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539517|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539518|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539519|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539520|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539521|NCT00195663|O3|Outcome|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539522|NCT00195663|O2|Outcome|Adalimumab|Participants received adalimumab 40 mg subcutaneous injection once every other week and placebo to methotrexate orally once a week during the 2-year double-blind treatment phase.
539523|NCT00195663|O1|Outcome|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539524|NCT00195663|E4|Reported Event|Any Adalimumab|"Participants received either methotrexate, adalimumab, or methotrexate + adalimumab during the 2-year double-blind treatment phase. During the 8-year open-label phase all participants received adalimumab 40 mg every other week.~Adverse events reported include those that occurred at any time during adalimumab exposure (up to 10 years)."
539525|NCT00195663|E3|Reported Event|Adalimumab + Methotrexate|Participants received adalimumab 40 mg subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539605|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
539606|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
539527|NCT00195663|E1|Reported Event|Methotrexate|Participants received placebo to adalimumab subcutaneous injection once every other week and methotrexate orally once a week at a starting dose of 7.5 mg/week (could be escalated up to 20 mg/week) during the 2-year double-blind treatment phase.
539528|NCT00195650|B1|Baseline|Adalimumab|Open-label adalimumab 40 mg
539529|NCT00195650|P1|Participant Flow|Adalimumab|Open-label adalimumab 40 mg
539530|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539531|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539532|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539533|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539534|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539535|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539536|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539537|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539538|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539539|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539540|NCT00195650|O1|Outcome|Adalimumab|Open-label adalimumab 40 mg
539541|NCT00195650|E1|Reported Event|Adalimumab|Open-label adalimumab 40 mg
539542|NCT00195507|B3|Baseline|Total|Total of all reporting groups
539543|NCT00195507|B2|Baseline|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539544|NCT00195507|B1|Baseline|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539545|NCT00195507|P2|Participant Flow|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539546|NCT00195507|P1|Participant Flow|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539547|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539548|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539549|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539550|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539551|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539552|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539553|NCT00195507|O2|Outcome|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539554|NCT00195507|O1|Outcome|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539555|NCT00195507|E2|Reported Event|Intermittent|etanercept 50 mg SC twice weekly for 12 weeks, or less if a response was achieved earlier. If after 12 weeks there was an inadequate response or a relapse, etanercept 25 mg twice weekly was administered until a response was achieved.
539556|NCT00195507|E1|Reported Event|Continuous|etanercept 25 mg subcutaneously (SC) twice weekly for 54 weeks
539557|NCT00195494|B3|Baseline|Total|Total of all reporting groups
539558|NCT00195494|B2|Baseline|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539559|NCT00195494|B1|Baseline|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539560|NCT00195494|P6|Participant Flow|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539561|NCT00195494|P5|Participant Flow|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539562|NCT00195494|P4|Participant Flow|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
539563|NCT00195494|P3|Participant Flow|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
539564|NCT00195494|P2|Participant Flow|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539565|NCT00195494|P1|Participant Flow|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539566|NCT00195494|O6|Outcome|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539607|NCT00195429|O1|Outcome|Sirolimus + Tacrolimus|
539608|NCT00195429|E2|Reported Event|Sirolimus + Prednisone|
539567|NCT00195494|O5|Outcome|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539568|NCT00195494|O4|Outcome|Year 2 M / M|"Following a blinded transition from year one- MTX dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
539569|NCT00195494|O3|Outcome|Year 2 E+M / E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
539570|NCT00195494|O2|Outcome|Year 2 M / E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539571|NCT00195494|O1|Outcome|Year 2 E+M / E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539572|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
539573|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
539574|NCT00195494|O2|Outcome|Year 1 E+M|etanercept injection 50mg once weekly and oral methotrexate capsules 7.5 mg once weekly at the same time
539575|NCT00195494|O1|Outcome|Year 1 M|Oral methotrexate capsules 7.5mg weekly and etanercept placebo at the same day and time.
539576|NCT00195494|E6|Reported Event|Year 1 E+M|"Etanercept injection- two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539577|NCT00195494|E5|Reported Event|Year 1 M+Placebo|"Oral Methotrexate capsules once weekly + two injections of placebo given at the same time at different sites.~MTX dose is a forced titration from 7.5mg (3 capsules) to 20 mg weekly (8 capsules) by week 8."
539578|NCT00195494|E4|Reported Event|Year 1 M / Year 2 M|"Following a blinded transition from year one- Methotrexate dose consistent with the ending dose of year one (usually 20 mgs).~No reduction of MTX dose is permitted in year two."
539579|NCT00195494|E3|Reported Event|Year 1 E+M / Year 2 E|Following a blinded transition from year one-Etanercept two injections 25 mg weekly (given at the same time at different sites).
539580|NCT00195494|E2|Reported Event|Year 1 M / Year 2 E+M|"Following a blinded transition from year one- Etanercept two injections 25 mg weekly (given at the same time at different sites) + oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539581|NCT00195494|E1|Reported Event|Year 1 E+M / Year 2 E+M|"Following a blinded transition from year one- Etanercept injection- two injections 25 mg weekly (given at the same time at different sites)+ oral Methotrexate capsules weekly (same day as injection).~Dose consistent with the ending dose at year one (usually 20 mgs). No reduction of MTX dose is permitted in year two."
539582|NCT00195442|B1|Baseline|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539583|NCT00195442|P1|Participant Flow|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539584|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539585|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539586|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539587|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539588|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539589|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539590|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539591|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539592|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539593|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539594|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539595|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539596|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539597|NCT00195442|O1|Outcome|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539598|NCT00195442|E1|Reported Event|ReFacto (Moroctocog Alfa)|B-domain deleted, recombinant factor VIII (BDDrFVIII) for participants with Hemophilia A in usual health care settings.
539599|NCT00195429|B3|Baseline|Total|Total of all reporting groups
539600|NCT00195429|B2|Baseline|Sirolimus + Prednisone|
539601|NCT00195429|B1|Baseline|Sirolimus + Tacrolimus|
539602|NCT00195429|P2|Participant Flow|Sirolimus + Prednisone|
539603|NCT00195429|P1|Participant Flow|Sirolimus + Tacrolimus|
539604|NCT00195429|O2|Outcome|Sirolimus + Prednisone|
539610|NCT00195403|B1|Baseline|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539611|NCT00195403|P1|Participant Flow|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539612|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539613|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539614|NCT00195403|O1|Outcome|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539615|NCT00195403|E1|Reported Event|Etanercept|Participants who had rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis and received etanercept subcutaneously as per local medical practitioner's discretion were observed up to 6 years. The recommended etanercept dose is 25 milligram (mg) subcutaneously twice weekly or 50 mg subcutaneously once weekly.
539616|NCT00195351|B3|Baseline|Total|Total of all reporting groups
539617|NCT00195351|B2|Baseline|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539618|NCT00195351|B1|Baseline|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539619|NCT00195351|P2|Participant Flow|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539620|NCT00195351|P1|Participant Flow|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539621|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539622|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539623|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539624|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539625|NCT00195351|O2|Outcome|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539626|NCT00195351|O1|Outcome|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539627|NCT00195351|E2|Reported Event|Ceftriaxone Sodium + Metronidazole|Ceftriaxone sodium 2 g administered intravenously once daily plus metronidazole 1 g to 2 g daily in divided IV doses.
539628|NCT00195351|E1|Reported Event|Tigecycline|Administered intravenously every 12 hours (an initial dose of 100 mg followed by 50 mg every 12 hours).
539629|NCT00195338|B1|Baseline|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539630|NCT00195338|P1|Participant Flow|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539631|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539632|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539633|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539634|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539635|NCT00195338|O1|Outcome|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539636|NCT00195338|E1|Reported Event|Etanercept|Etanercept (Enbrel) injection administered subcutaneously (s.c.) as per scientific leaflet specifications.
539637|NCT00195273|B3|Baseline|Total|Total of all reporting groups
539638|NCT00195273|B2|Baseline|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539665|NCT00195260|P1|Participant Flow|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539666|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539667|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539668|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539639|NCT00195273|B1|Baseline|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539640|NCT00195273|P2|Participant Flow|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539641|NCT00195273|P1|Participant Flow|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539642|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539643|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539644|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539645|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539646|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539669|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539670|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
540051|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
539647|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539648|NCT00195273|O2|Outcome|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539649|NCT00195273|O1|Outcome|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539650|NCT00195273|E2|Reported Event|Cyclosporine (CsA)|"Cyclosporine: first dose of 10mg/kg/day administered orally or via a NG-tube, no later than 24 hours after transplant. (First dose may be initiated prior to transplantation.) Subsequent doses given in equally divided doses (where possible) of twice daily at approximately 12-hour intervals. The subsequent doses should be adjusted to achieve target therapeutic ranges in whole blood.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539651|NCT00195273|E1|Reported Event|Sirolimus|"Sirolimus: initiated within 24 hours before or after transplantation; Loading dose of 15mg followed by 5mg/day (morning) until doses are adjusted to achieve steady state whole-blood trough levels of 10-15ng/ml during months 1-6, followed by 8-12ng/ml during months 7-12 Daclizumab: administered intravenously over 15 minutes at a dose of 1mg/kg to a maximum of 100mg per dose. First dose administered within24 hours before transplantation, with subsequent doses at weeks 2, 4, 6 and 8 weeks after transplantation, for a total of five doses.~Mycophenolate mofetil: 1000mg twice daily. Dose can be reduced to 750mg twice daily in the case of adverse events and reduced further to 500mg if adverse events persist.~Corticosteroids: given according to transplant center standard of care pre- and postoperatively. By day 8 prednisolone should be tapered to 20mg/day, by day 30 to 15mg/day, by day 60 to 10mg/day, and after 4-6 months to 5-7.5mg/day."
539652|NCT00195260|B3|Baseline|Total|Total of all reporting groups
539653|NCT00195260|B2|Baseline|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539654|NCT00195260|B1|Baseline|Part 1|Participants received bosutinib capsule orally once daily continuously in 21-day cycles in dose escalation schemes of 50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in (500 mg) until disease progression, unacceptable toxicity, or consent withdrawal.
539655|NCT00195260|P11|Participant Flow|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539656|NCT00195260|P10|Participant Flow|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539657|NCT00195260|P9|Participant Flow|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539658|NCT00195260|P8|Participant Flow|Maximum Tolerated Dose (MTD) lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539659|NCT00195260|P7|Participant Flow|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539660|NCT00195260|P6|Participant Flow|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539661|NCT00195260|P5|Participant Flow|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539662|NCT00195260|P4|Participant Flow|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539663|NCT00195260|P3|Participant Flow|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539664|NCT00195260|P2|Participant Flow|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
543746|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
539671|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539672|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539673|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539674|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539675|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539676|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
539677|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539678|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539679|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539680|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539681|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539682|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539683|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
539684|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539685|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539686|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539687|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539688|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539689|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539690|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
539691|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539692|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539693|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539694|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539695|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539696|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539697|NCT00195260|O5|Outcome|Bosutinib 400 mg (Part 1 + Part 2)|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal in both Part 1 and Part 2 participants.
539698|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539699|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539700|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539701|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539702|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539703|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539704|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539705|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539706|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539707|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539708|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539709|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539710|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539711|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539712|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539713|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539714|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539715|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539716|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539717|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539718|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539719|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539720|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539721|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539722|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539723|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539724|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539725|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539726|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539727|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539728|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539729|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539730|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539731|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539732|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539733|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539734|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539735|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539736|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539737|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539847|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539738|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539739|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539740|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539741|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539742|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539743|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539744|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539745|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539746|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539747|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539748|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539749|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539750|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539751|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539752|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539753|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539754|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539755|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539756|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539757|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539758|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539759|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539760|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539761|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539762|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539763|NCT00195260|O1|Outcome|All Participant|All participants who received bosutinib capsule (50 mg, 100 mg, 200 mg, 300 mg, 400 mg, 500 mg, 600 mg, MTD-lead in) orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539764|NCT00195260|O3|Outcome|Non-small Cell Lung Cancer (NSCLC)|Participants with NSCLC received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539765|NCT00195260|O2|Outcome|Pancreatic Cancer|Participants with pancreatic cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539766|NCT00195260|O1|Outcome|Colorectal Cancer|Participants with colorectal cancer received bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539767|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539768|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539769|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539770|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
540052|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
539771|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539772|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539773|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539774|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539775|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539776|NCT00195260|O8|Outcome|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539777|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539778|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539779|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539780|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539781|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539782|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539783|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539784|NCT00195260|O9|Outcome|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539785|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539786|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539787|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539788|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539789|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539790|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539791|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539792|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539793|NCT00195260|O8|Outcome|MTD-lead in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539794|NCT00195260|O7|Outcome|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539795|NCT00195260|O6|Outcome|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539796|NCT00195260|O5|Outcome|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539797|NCT00195260|O4|Outcome|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539798|NCT00195260|O3|Outcome|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539799|NCT00195260|O2|Outcome|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539800|NCT00195260|O1|Outcome|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539801|NCT00195260|E9|Reported Event|RP2D 400 mg|Participants with colorectal cancer, pancreatic cancer, NSCLC received RP2D of bosutinib (400 mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539802|NCT00195260|E8|Reported Event|MTD lead-in|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539803|NCT00195260|E7|Reported Event|Bosutinib 600 mg|Bosutinib 600 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539804|NCT00195260|E6|Reported Event|Bosutinib 500 mg|Bosutinib 500 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
540053|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
539805|NCT00195260|E5|Reported Event|Bosutinib 400 mg|Bosutinib 400 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539806|NCT00195260|E4|Reported Event|Bosutinib 300 mg|Bosutinib 300 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539807|NCT00195260|E3|Reported Event|Bosutinib 200 mg|Bosutinib 200 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539808|NCT00195260|E2|Reported Event|Bosutinib 100 mg|Bosutinib 100 mg capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539809|NCT00195260|E1|Reported Event|Bosutinib 50 mg|Bosutinib 50 milligram (mg) capsule orally once daily continuously in 21-day cycles until disease progression, unacceptable toxicity, or consent withdrawal.
539810|NCT00194896|B5|Baseline|Total|Total of all reporting groups
539811|NCT00194896|B4|Baseline|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539812|NCT00194896|B3|Baseline|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
539813|NCT00194896|B2|Baseline|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539814|NCT00194896|B1|Baseline|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
539815|NCT00194896|P4|Participant Flow|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539816|NCT00194896|P3|Participant Flow|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
539817|NCT00194896|P2|Participant Flow|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539818|NCT00194896|P1|Participant Flow|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
539819|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539820|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
539821|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539848|NCT00194675|E2|Reported Event|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
540054|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
539822|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
539823|NCT00194896|O4|Outcome|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539824|NCT00194896|O3|Outcome|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
539825|NCT00194896|O2|Outcome|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539826|NCT00194896|O1|Outcome|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
539827|NCT00194896|E4|Reported Event|Glyburide Autoantibody Negative|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539828|NCT00194896|E3|Reported Event|Glyburide Autoantibody Positive|Glyburide is a sulfonylurea. Glyburide therapy was initiated with 2.5 mg in the morning or the patient was maintained on the dose they had been receiving prior to starting the study. This starting dose was raised by 2.5 in the evening and further up to a maximum of 10 mg twice a day if necessary to achieve desired glycemic control. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), islet cell autoantibodies 512 (IA2).
539829|NCT00194896|E2|Reported Event|Rosiglitazone Autoantibody Negative|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 mg once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody negative for insulin autoantibodies (IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD), and islet cell autoantibodies 512 (IA2).
539830|NCT00194896|E1|Reported Event|Rosiglitazone Autoantibody Positive|Rosiglitazone is an oral antidiabetic agent which acts primarily by increasing insulin sensitivity. The rosiglitazone treatment group commenced therapy with 4 milligram (mg) once per day and increase to twice per day if adequate glycemic control was not achieved. Autoantibody positive for one or multiple islet autoantibodies. These autoantibodies include insulin autoantibodies(IAA), islet cell autoantibodies (ICA), glutamic acid decarboxylase (GAD),and/or islet cell autoantibodies 512 (IA2).
539831|NCT00194675|B3|Baseline|Total|Total of all reporting groups
539832|NCT00194675|B2|Baseline|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
539833|NCT00194675|B1|Baseline|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539834|NCT00194675|P2|Participant Flow|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
539835|NCT00194675|P1|Participant Flow|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539836|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
539837|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539838|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
539839|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
539840|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% gel 7.5 daily + dutasteride 0.5 mg po daily
539841|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% gel 7.5 daily + oral placebo dutasteride daily
539842|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
539843|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539844|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
539845|NCT00194675|O1|Outcome|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539846|NCT00194675|O2|Outcome|Testosterone Gel + Oral Dutasteride|Testosterone 1% topical gel 7.5g daily + dutasteride 0.5 mg orally daily for 6 months
543747|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
539849|NCT00194675|E1|Reported Event|Testosterone Gel + Oral Placebo|Testosterone 1% topical gel 7.5g daily + placebo dutasteride pill orally daily for 6 months
539850|NCT00194610|B3|Baseline|Total|Total of all reporting groups
539851|NCT00194610|B2|Baseline|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
539852|NCT00194610|B1|Baseline|Saline|Total 2 cc injected periurethrally
539853|NCT00194610|P2|Participant Flow|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
539854|NCT00194610|P1|Participant Flow|Saline|Total 2 cc injected periurethrally
539855|NCT00194610|O2|Outcome|Experimental Intervention: Botox|Botulinum toxin 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible, but not mandatory, injections of 25 IU in each of 2 trigger points.
539856|NCT00194610|O1|Outcome|Placebo : Saline|Saline 2 cc total injected periurethrally
539857|NCT00194610|E2|Reported Event|Botox|Botox 25 IU injected bilaterally periurethrally for a total of 50 IU. Possible but not mandatory was two more injections of 25 IU in each of two trigger points
539858|NCT00194610|E1|Reported Event|Saline|Total 2 cc injected periurethrally
539859|NCT00194532|B3|Baseline|Total|Total of all reporting groups
539860|NCT00194532|B2|Baseline|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
539861|NCT00194532|B1|Baseline|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
539862|NCT00194532|P2|Participant Flow|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
539863|NCT00194532|P1|Participant Flow|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
539864|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
539865|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
539866|NCT00194532|O2|Outcome|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
539867|NCT00194532|O1|Outcome|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
539868|NCT00194532|E2|Reported Event|Cefpodoxime|Cefpodoxime 100 mg BID X 3 days
539869|NCT00194532|E1|Reported Event|Ciprofloxacin|Ciprofloxacin 250 mg BID X 3 days
539870|NCT00194129|B3|Baseline|Total|Total of all reporting groups
539871|NCT00194129|B2|Baseline|Lithium Plus Placebo|
539872|NCT00194129|B1|Baseline|Lithium Plus Divalproex|
539873|NCT00194129|P2|Participant Flow|Lithium Plus Placebo|
539874|NCT00194129|P1|Participant Flow|Lithium Plus Divalproex|
539875|NCT00194129|O2|Outcome|Lithium Plus Placebo|
539876|NCT00194129|O1|Outcome|Lithium Plus Divalproex|
539877|NCT00194129|E2|Reported Event|Lithium Plus Placebo|
539878|NCT00194129|E1|Reported Event|Lithium Plus Divalproex|
539879|NCT00194077|B3|Baseline|Total|Total of all reporting groups
539880|NCT00194077|B2|Baseline|Placebo|Placebo (Children with Symptoms of Mania Study)
539881|NCT00194077|B1|Baseline|Aripiprazole|Abilify (Children with Symptoms of Mania Study)
539882|NCT00194077|P2|Participant Flow|Placebo|Randomized assignment to placebo
539883|NCT00194077|P1|Participant Flow|Aripiprazole|Random assignment with titrated dosing
539884|NCT00194077|O2|Outcome|Placebo|Placebo dosing to mirror active treatment
539885|NCT00194077|O1|Outcome|Aripiprazole|Aripiprazole dosing dependent upon response
539886|NCT00194077|E2|Reported Event|Placebo|Placebo (Children With Symptoms of Mania Study)
539887|NCT00194077|E1|Reported Event|Aripiprazole|Abilify (Children With Symptoms of Mania Study)
539888|NCT00194025|B1|Baseline|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539889|NCT00194025|P1|Participant Flow|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539890|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539891|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539892|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539916|NCT00193609|E1|Reported Event|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
539917|NCT00193596|B3|Baseline|Total|Total of all reporting groups
540055|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
539893|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539894|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539895|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539896|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539897|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539898|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539899|NCT00194025|O1|Outcome|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539900|NCT00194025|E1|Reported Event|Valproate|Enrolled individuals received adjunctive, openlabel valproate semisodium, initially started as valproate semisodium delayed-release 250 mg at bedtime for two weeks, then changed to valproate semisodium extended-release 500 mg at bedtime. Medication was administered on an outpatient/ambulatory basis, and adjusted as tolerated to target serum levels of 50– 100 mg/mL. In cases where sedation or other side effects occurred, dosage was reduced. Valproate semisodium was prescribed in a single dose at bedtime.
539901|NCT00194012|B3|Baseline|Total|Total of all reporting groups
539902|NCT00194012|B2|Baseline|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539903|NCT00194012|B1|Baseline|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539904|NCT00194012|P2|Participant Flow|Placebo|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539905|NCT00194012|P1|Participant Flow|Aripiprazle|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539906|NCT00194012|O2|Outcome|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539907|NCT00194012|O1|Outcome|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539908|NCT00194012|E4|Reported Event|Open Label Extension Phase|Previously randomized to placebo
539909|NCT00194012|E3|Reported Event|Abilify Open Label Extension|Previously randomized to abilify
539910|NCT00194012|E2|Reported Event|Placebo Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539911|NCT00194012|E1|Reported Event|Abilify Randomized Phase|abilify (aripiprazole) : dosing is 2mg, 5mg, 7mg, 10mg, 12mg or 15 mg depending on response and during the double blind arms may be randomized to placebo
539912|NCT00193609|B1|Baseline|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
539913|NCT00193609|P1|Participant Flow|Oxaliplatin/Capecitabine|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
539914|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
539915|NCT00193609|O1|Outcome|Intervention|All patients received treatment with oxaliplatin 130mg/m2, given intravenously on day 1 of each 21 day cycle. Capecitabine 1000mg/m2 by mouth twice daily was administered on days 1-14 of each cycle.
539918|NCT00193596|B2|Baseline|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
539919|NCT00193596|B1|Baseline|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
539920|NCT00193596|P2|Participant Flow|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
539921|NCT00193596|P1|Participant Flow|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
539922|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
539923|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
539924|NCT00193596|O2|Outcome|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
539925|NCT00193596|O1|Outcome|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
539926|NCT00193596|E2|Reported Event|Irinotecan/Gemcitabine/Gefitinib|"Irinotecan 100 mg/m2 IV, days 1 and 8~Gemcitabine 1000 mg/m2 IV, days 1 and 8~Regimen B was repeated at a 21-day interval"
539927|NCT00193596|E1|Reported Event|Paclitaxel/Carboplatin/Etoposide/Gefitinib|"Paclitaxel 200 mg/m2 by 1-hour IV infusion, day 1~Carboplatin area under the curve (AUC) 6.0 IV, day 1~Etoposide 50 mg alternating with 100 mg by mouth, days 1 and 10~Regimen A was repeated at a 21-day interval"
539928|NCT00193492|B3|Baseline|Total|Total of all reporting groups
539929|NCT00193492|B2|Baseline|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
539930|NCT00193492|B1|Baseline|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
539931|NCT00193492|P2|Participant Flow|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
539932|NCT00193492|P1|Participant Flow|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
539933|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
539934|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
539935|NCT00193492|O2|Outcome|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
539936|NCT00193492|O1|Outcome|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
539937|NCT00193492|E2|Reported Event|Rituximab/Bevacizumab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). During the 4-week course of rituximab, all patients will receive 2 doses of bevacizumab 10mg/kg IV, given on Days 3 and 15. The first dose will be given on Day 3, following rituximab on Day 1. If both drugs are well tolerated during the first dose, rituximab and bevacizumab should be given on the same day for the Day 15 dose and all subsequent doses.~Bevacizumab~Rituximab"
539938|NCT00193492|E1|Reported Event|Rituximab|"All patients will receive rituximab 375mg/m2 administered by slow IV infusion weekly for 4 consecutive weeks (days 1, 8, 15, and 22). Patients who have objective response or stable disease at week 12 reevaluation will receive 4 additional doses of rituximab (375 mg/m2) administered in months 3 (week 12), 5, 7, and 9.~Rituximab"
539959|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539939|NCT00193479|B1|Baseline|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
539940|NCT00193479|P1|Participant Flow|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
539941|NCT00193479|O1|Outcome|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
539942|NCT00193479|E1|Reported Event|CNOP (CVP)/Rituximab/Pegfilgrastim Followed by Rituximab|Cyclophosphamide 500mg/m2 IV day 1; Mitoxantrone 10mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2 OR Cyclophosphamide 500mg/m2 IV day 1; Vincristine 1.0mg/m2 IV day 1; Prednisone 80mg PO days 1-5; Rituximab 375mg/m2 IV day 1; Pegfilgrastim 6mg SQ, day 2
539943|NCT00193453|B1|Baseline|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539944|NCT00193453|P1|Participant Flow|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539945|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539946|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539947|NCT00193453|O1|Outcome|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539948|NCT00193453|E1|Reported Event|Intervention|Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
539949|NCT00193427|B1|Baseline|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539950|NCT00193427|P1|Participant Flow|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539951|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539952|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539953|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered.
539954|NCT00193427|O1|Outcome|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539955|NCT00193427|E1|Reported Event|Intervention|Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
539956|NCT00193414|B1|Baseline|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539957|NCT00193414|P1|Participant Flow|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539958|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539960|NCT00193414|O1|Outcome|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539961|NCT00193414|E1|Reported Event|Intervention|Chemotherapy-naïve patients with unresectable stage III/IV NSCLC received pemetrexed 500 mg/m2 IV and gemcitabine 1500 mg/m2 IV every 2 weeks for 8-12 cycles with restaging every 4 cycles. Patients also received supplemental folate/B12 therapy.
539962|NCT00193375|B1|Baseline|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539963|NCT00193375|P1|Participant Flow|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539964|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539965|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539966|NCT00193375|O1|Outcome|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539967|NCT00193375|E1|Reported Event|Intervention|Patients received carboplatin [area under the concentration-versus-time curve of 5 intravenously (IV) day 1 every 3 weeks x 4), irinotecan (50mg/m2 IV days 1 and 8 every 3 weeks x 4], and radiation (1.8 Gy daily to a total of 61.2 Gy beginning with the 3rd cycle). Cycles 3 and 4 were 28 days each; with restaging after 4 cycles. Patients without progressive disease received bevacizumab (10 mg/kg IV every 14 days x 10).
539968|NCT00193258|B1|Baseline|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539969|NCT00193258|P1|Participant Flow|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539970|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539971|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539972|NCT00193258|O1|Outcome|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539973|NCT00193258|E1|Reported Event|Bevacizumab/Erlotinib/Imatinib|In the phase I portion: Bevacizumab 10 mg/kg slow IV infusion on days 1 and 15 of each 28-day course Erlotinib 150 mg orally daily Imatinib 300 mg orally daily or 400 mg orally daily In the phase II portion: Bevacizumab 10 mg/kg 30-60 minute IV infusion on days 1 and 15 of every 28 day cycle Erlotinib 150 mg orally daily Imatinib 400 mg orally daily
539974|NCT00193219|B1|Baseline|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539975|NCT00193219|P1|Participant Flow|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539976|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539977|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539978|NCT00193219|O1|Outcome|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539979|NCT00193219|E1|Reported Event|Bevacizumab/Cetuximab/FOLFOX|Bevacizumab 5 mg/kg IV Cetuximab 400 mg/m2 (first cycle only) IV on day 1 and 250 mg/m2 IV on day 8 with all subsequent cycles 250 mg/m2 IV on days 1 and 8 5-Fluorouracil 400 mg/m2 bolus IV bolus followed by 2400 mg/m2 administered as continuous IV infusion over 46 hours via pump (outpatient) Leucovorin 350 mg IV Oxaliplatin 85 mg/m2 IV
539980|NCT00193206|B1|Baseline|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
539981|NCT00193206|P1|Participant Flow|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
539982|NCT00193206|O1|Outcome|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
539983|NCT00193206|E1|Reported Event|Intervention|"Systemic Therapy~ABI-007 : ABI-007 175 mg/m2 D1 q 14 days x 6 cycles~Epirubicin : Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles~Gemcitabine : Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles"
539984|NCT00193180|B1|Baseline|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
539985|NCT00193180|P1|Participant Flow|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
539986|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m^2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
539987|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
539988|NCT00193180|O1|Outcome|Intervention|All patients in this study received docetaxel 30 mg/m2 weekly for 3 consecutive weeks of each 28-day cycle, along with continuous imatinib mesylate. Initially, imatinib mesylate was given at a dose of 600 mg orally daily, beginning concurrently with the first dose of docetaxel; however, after the first 15 patients were treated it became evident that this imatinib dose was not tolerable, and subsequent patients received imatinib mesylate 400 mg orally daily.
539989|NCT00193180|E1|Reported Event|Docetaxel+Imatinib|Patients received docetaxel 30mg/m2 IV weekly on days 1, 8, and 15 of each 28 day cycle. Patients received oral imatinib 400mg daily. Fifteen patients initially received oral imatinib 600mg daily but had their dose reduced to 400mg daily when they were unable to tolerate the higher dose.
539990|NCT00193128|B3|Baseline|Total|Total of all reporting groups
539991|NCT00193128|B2|Baseline|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539992|NCT00193128|B1|Baseline|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539993|NCT00193128|P2|Participant Flow|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539994|NCT00193128|P1|Participant Flow|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
540047|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540048|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
543748|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
539995|NCT00193128|O2|Outcome|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539996|NCT00193128|O1|Outcome|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539997|NCT00193128|E2|Reported Event|Oxaliplatin/Docetaxel/Capecitabine/Radiation|"After completion of the first phase of the trial, the second cohort began treatment.~Oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Capecitabine was administered 1000 mg/m2 orally twice daily on days 1 to 7, 15 to 21, and 29 to 35. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539998|NCT00193128|E1|Reported Event|Oxaliplatin/Docetaxel/Radiation|"An initial cohort of 10 patients was treated with oxaliplatin 40 mg/m2 intravenously (IV) over 2 hours and docetaxel 20 mg/m2 IV over 30 minutes on days 1, 8, 15, 22, and 29. Radiation therapy began concurrently with day 1 of chemotherapy at a dose of 1.8 Gy/d Monday through Friday to a total of 45 Gy (25 fractions).~Patients were to have esophageal resection after completion of preoperative therapy during weeks 9 to 12 and after all treatment-related side effects were resolved."
539999|NCT00193063|B1|Baseline|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540000|NCT00193063|P1|Participant Flow|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540001|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540002|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540003|NCT00193063|O1|Outcome|Gemcitabine/Trastuzumab|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540004|NCT00193063|E1|Reported Event|Intervention|All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
540005|NCT00193050|B1|Baseline|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
540006|NCT00193050|P1|Participant Flow|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
540007|NCT00193050|O1|Outcome|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
540008|NCT00193050|E1|Reported Event|Intervention|"In the neoadjuvant setting, patients were administered gemcitabine (800 mg/m2 IV days 1 and 8), epirubicin (75 mg/m2 IV day 1), and docetaxel (30 mg/m2 IV days 1 and 8)repeated every 21 days for 4 cycles~Patients then had either mastectomy or breast conservation surgery and pathologic treatment responses were assessed.~After surgery, 4 cycles of adjuvant gemcitabine (1000 mg/m2 IV days 1 and 8) and docetaxel (35 mg/m2 IV days 1 and 8) were administered at 21 day intervals.~After completion of chemotherapy, local regional radiation therapy and/or anti-estrogen therapy was administered per standard guidelines."
540009|NCT00193037|B3|Baseline|Total|Total of all reporting groups
540049|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540010|NCT00193037|B2|Baseline|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
540011|NCT00193037|B1|Baseline|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
540012|NCT00193037|P2|Participant Flow|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria."
540013|NCT00193037|P1|Participant Flow|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided patient still met the eligibility laboratory and performance status criteria."
540014|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
540015|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
540016|NCT00193037|O2|Outcome|Arm B - Docetaxel Then Liposomal Doxorubicin|"Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8 and 15 followed by one week rest, administered on a q 28 day cycle. This dosing schedule will define one cycle.~Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided the patient still met the eligibility laboratory and performance status criteria."
540017|NCT00193037|O1|Outcome|Arm A -Liposomal Doxorubicin Then Docetaxel|"Liposomal doxorubicin (Arm A)~Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q 28 days thru peripheral vein or central venous access. This will define one cycle.~Patients demonstrating progression on Liposomal Doxorubicin were eligible for cross over to treatment on Docetaxel, provided the patient still met the eligibility laboratory and performance status criteria."
540018|NCT00193037|E2|Reported Event|Arm B - Docetaxel Then Liposomal Doxorubicin|Weekly docetaxel 36 mg/m2 IV over 30 minutes on days 1, 8, and 15 followed by one week rest, administered on an every 28 day cycle. This dosing schedule will define one cycle. Patients demonstrating progression on Docetaxel were eligible for cross over to treatment on Liposomal Doxorubicin, provided patient still met the eligibility laboratory and performance status criteria.
540019|NCT00193037|E1|Reported Event|Arm A - Liposomal Doxorubicin Then Docetaxel|Liposomal doxorubicin 40 mg/m2 IV day 1 over one hour, repeated q28 days thru peripheral vein or central venous access. This will define one cycle. Patients demonstrating progression on Liposomal Doxorubicin were eligible for crossover to treatment on Docetaxel, provided patient still met the eligibility lab and performance status criteria.
540020|NCT00192296|B5|Baseline|Total|Total of all reporting groups
540021|NCT00192296|B4|Baseline|MEDI-528 9 mg|
540022|NCT00192296|B3|Baseline|MEDI-528 3 mg|
540023|NCT00192296|B2|Baseline|MEDI-528 1 mg|
540024|NCT00192296|B1|Baseline|MEDI-528 0.3 mg|
540025|NCT00192296|P4|Participant Flow|MEDI-528 9 mg|
540026|NCT00192296|P3|Participant Flow|MEDI-528 3 mg|
540027|NCT00192296|P2|Participant Flow|MEDI-528 1 mg|
540028|NCT00192296|P1|Participant Flow|MEDI-528 0.3 mg|
540029|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540030|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540031|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540032|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540033|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540034|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540035|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540036|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540037|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540038|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540039|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540040|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540041|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540042|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540043|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540044|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540045|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540046|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
543749|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
540056|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540057|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540058|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540059|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540060|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540061|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540062|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540063|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540064|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540065|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540066|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540067|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540068|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540069|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540070|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540071|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540072|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540073|NCT00192296|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, IV dose
540074|NCT00192296|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, IV dose
540075|NCT00192296|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, IV dose
540076|NCT00192296|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, intravenous (IV) dose
540077|NCT00192296|E4|Reported Event|MEDI-528 9 mg|
540078|NCT00192296|E3|Reported Event|MEDI-528 3 mg|
540079|NCT00192296|E2|Reported Event|MEDI-528 1 mg|
540080|NCT00192296|E1|Reported Event|MEDI-528 0.3 mg|
540081|NCT00192647|B3|Baseline|Total|Total of all reporting groups
540082|NCT00192647|B2|Baseline|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540083|NCT00192647|B1|Baseline|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540084|NCT00192647|P2|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540085|NCT00192647|P1|Participant Flow|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with peginterferon (PEG-IFN) alfa-2a (Pegasys), 360 micrograms (mcg) subcutaneous (SC) once weekly, along with ribavirin, 1000 or 1200 milligrams (mg) orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540086|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540087|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540088|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540089|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540090|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540091|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540092|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540127|NCT00192075|E1|Reported Event|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540370|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540093|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540094|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540095|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540096|NCT00192647|O2|Outcome|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540097|NCT00192647|O1|Outcome|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540098|NCT00192647|E2|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Standard Treatment|Participants received 48 weeks of standard therapy with PEG-IFN alfa-2a, 180 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight.
540099|NCT00192647|E1|Reported Event|PEG-IFN Alfa-2a+Ribavirin – Induction Treatment|Participants received 12 weeks of induction therapy with PEG-IFN alfa-2a, 360 mcg SC once weekly, along with ribavirin, 1000 or 1200 mg orally daily in divided doses, with the dose determined based on body weight. Thereafter, the dose of PEG-IFN alfa-2a was reduced to 180 mcg SC once weekly and the ribavirin dose was maintained for the next 36 weeks of treatment.
540100|NCT00192075|B3|Baseline|Total|Total of all reporting groups
540101|NCT00192075|B2|Baseline|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540102|NCT00192075|B1|Baseline|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540103|NCT00192075|P2|Participant Flow|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540104|NCT00192075|P1|Participant Flow|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540105|NCT00192075|O1|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540106|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540107|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540108|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
540109|NCT00192075|O1|Outcome|A+FFG - Avastin Subgrouup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
540110|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
540111|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
540112|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
540113|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
540114|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Includes patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
540115|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
540116|NCT00192075|O2|Outcome|A + FOLFOX 4 - Avastin Subgroup|Patients who received Avastin plus oxaliplatin plus 5FU/Folinic Acid
540117|NCT00192075|O1|Outcome|A+FFG - Avastin Subgroup|Patients who received Avastin plus gemcitabine plus 5FU/Folinic Acid
540118|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540119|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540120|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540121|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540122|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540123|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540124|NCT00192075|O2|Outcome|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540125|NCT00192075|O1|Outcome|A+FFG|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus gemcitabine plus 5FU/Folinic Acid)
540126|NCT00192075|E2|Reported Event|A + FOLFOX 4|Includes all patients in the intent-to-treat population including patients administered Avastin (Avastin plus oxaliplatin plus 5FU/Folinic Acid)
540128|NCT00192036|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540129|NCT00192036|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540130|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540131|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540132|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540133|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540134|NCT00192036|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous, day 1 and day 8 every 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5).~Cisplatin: 80 mg/m2, intravenous, every 21 days x 5 cycles. Radiation: 63 Gray (Gy) in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5."
540135|NCT00192036|E1|Reported Event|Gemcitabine + Cisplatin|Gemcitabine: 1250 mg/m2, IV, day 1 and day 8 q 21 days x 3 cycles (1-3) then 300 mg/m2 x 2 cycles (4-5) Cisplatin: 80 mg/m2, IV, q 21 days x 5 cycles Radiation: 63 Gy in 35 treatments over 7 weeks concurrent with chemotherapy cycles 4 and 5
540136|NCT00192023|B3|Baseline|Total|Total of all reporting groups
540137|NCT00192023|B2|Baseline|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540138|NCT00192023|B1|Baseline|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540139|NCT00192023|P2|Participant Flow|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540140|NCT00192023|P1|Participant Flow|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540141|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540142|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540143|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540144|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540145|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540146|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540147|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540148|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540149|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540150|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540151|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540152|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540153|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540154|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540155|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540156|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540157|NCT00192023|O2|Outcome|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540158|NCT00192023|O1|Outcome|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540159|NCT00192023|E2|Reported Event|Placebo|placebo, daily (QD), by mouth (PO) for 8 weeks, then possibility to switch to atomoxetine at 0.5 mg/kg/day QD, PO for 1 week, then to 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540160|NCT00192023|E1|Reported Event|Atomoxetine|atomoxetine 0.5 mg/kg/day daily (QD), by mouth (PO) for 1 week, 1.2 mg/kg/day QD, PO for 7 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1.5 years or until atomoxetine received marketing approval.
540161|NCT00191984|B1|Baseline|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540162|NCT00191984|P1|Participant Flow|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540163|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540164|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540165|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540166|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540167|NCT00191984|O1|Outcome|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540168|NCT00191984|E1|Reported Event|Pemetrexed + Irinotecan|Pemetrexed: 400 mg/m2, intravenous (IV), every 14 days x 12 cycles Irinotecan: 180 mg/m2, intravenous (IV), every 14 days x 12 cycles
540169|NCT00191945|B3|Baseline|Total|Total of all reporting groups
540170|NCT00191945|B2|Baseline|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540171|NCT00191945|B1|Baseline|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540172|NCT00191945|P2|Participant Flow|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540173|NCT00191945|P1|Participant Flow|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540174|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540175|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540176|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540177|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540178|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540179|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540180|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540181|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540182|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
540183|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540184|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540185|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540186|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540187|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540188|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540189|NCT00191945|O1|Outcome|Atomoxetine|0.5 mg/kg/day QD, PO for 2 weeks, 1.2 - 1.4 mg/kg/day QD, PO for 10 weeks, then 1.2 - 1.4 mg/kg/day QD, PO for up to 1 year
540190|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540191|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540192|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540193|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540194|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540195|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540196|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540197|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540198|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540199|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540200|NCT00191945|O2|Outcome|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540201|NCT00191945|O1|Outcome|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540202|NCT00191945|E2|Reported Event|Placebo|Double-Blind Acute Period: every day, by mouth for 12 weeks,then possibility to switch to atomoxetine at 0.5 mg/kg/day every day, by mouth for 1 week Open-Label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540203|NCT00191945|E1|Reported Event|Atomoxetine|Double-Blind Acute Period: 0.5 mg/kg/day every day, by mouth for 2 weeks, 1.2 - 1.4 mg/kg/day every day, by mouth for 10 weeks Open-label Period: 1.2 - 1.4 mg/kg/day every day, by mouth for up to 1 year
540204|NCT00191906|B5|Baseline|Total|Total of all reporting groups
540205|NCT00191906|B4|Baseline|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
540206|NCT00191906|B3|Baseline|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
540207|NCT00191906|B2|Baseline|Placebo First, Then Atomoxetine|Placebo for 4 weeks, 2 week washout, and then atomoxetine 1.2 mg/kg/day for 4 weeks.
540208|NCT00191906|B1|Baseline|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day for 4 weeks, 2 week washout, and then placebo for 4 weeks
540209|NCT00191906|P4|Participant Flow|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
540210|NCT00191906|P3|Participant Flow|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
540211|NCT00191906|P2|Participant Flow|Placebo First, Then Atomoxetine|Placebo every day, by mouth for 4 weeks, 2 week washout period and then cross-over to atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks.
540212|NCT00191906|P1|Participant Flow|Atomoxetine First, Then Placebo|Atomoxetine 1.2 mg/kg/day, by mouth for 4 weeks, 2 week washout period and then cross-over to placebo, every day, by mouth for 4 weeks.
540213|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
540214|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
540215|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
540216|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
540217|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
540218|NCT00191906|O1|Outcome|ADHD-C+ RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
540219|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
540220|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
540221|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
540222|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
540223|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540224|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540225|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540226|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540227|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540228|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540229|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540230|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540231|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540232|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540233|NCT00191906|O2|Outcome|Placebo|
540234|NCT00191906|O1|Outcome|Atomoxetine|
540235|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540236|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540237|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540238|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540239|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540240|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540241|NCT00191906|O3|Outcome|Reading Disordered Control|Untreated reading disordered control group was comprised of children with reading disorder who received standard remedial teaching therapy.
540242|NCT00191906|O2|Outcome|Reading Disorder|atomoxetine-treated Reading Disorder
540243|NCT00191906|O1|Outcome|ADHD-C+RD|atomoxetine-treated Comorbid Attention-Deficit/Hyperactivity Disorder-Combined Type + Reading Disorder
540244|NCT00191906|O2|Outcome|Normal Control|Untreated normal controls were children selected from the general population. The normal control was matched (have same proportion) by sex (male/female) and by age (have same age range) as the study population.
540245|NCT00191906|O1|Outcome|ADHD-C|atomoxetine-treated Attention-Deficit/Hyperactivity Disorder-Combined Type
540246|NCT00191906|O2|Outcome|Placebo|Placebo, daily, by mouth for 4 weeks.
540247|NCT00191906|O1|Outcome|Atomoxetine|Atomoxetine, 1.2 mg/kg/day, by mouth for 4 weeks.
540248|NCT00191906|E3|Reported Event|Open Label Atomoxetine|Patients in the Open Label extension receiving Atomoxetine
540249|NCT00191906|E2|Reported Event|As Randomized Atomoxetine (Crossover)|Patients in either Crossover Period receiving Atomoxetine
540250|NCT00191906|E1|Reported Event|As Randomized Placebo (Crossover)|Patients in either Crossover Period receiving Placebo
540251|NCT00191854|B4|Baseline|Total|Total of all reporting groups
540252|NCT00191854|B3|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540253|NCT00191854|B2|Baseline|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540254|NCT00191854|B1|Baseline|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540255|NCT00191854|P3|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540256|NCT00191854|P2|Participant Flow|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540257|NCT00191854|P1|Participant Flow|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540258|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540259|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540260|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540261|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540262|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540263|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540264|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540265|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
543750|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
540266|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540267|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540268|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540269|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540270|NCT00191854|O3|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540271|NCT00191854|O2|Outcome|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540272|NCT00191854|O1|Outcome|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540273|NCT00191854|E3|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Cisplatin: 50 mg/m2, IV, every 14 days x 8 cycles"
540274|NCT00191854|E2|Reported Event|Gemcitabine + Carboplatin|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Carboplatin: Area Under the Curve (AUC) 2.5, IV, every 14 days x 8 cycles"
540275|NCT00191854|E1|Reported Event|Gemcitabine + Paclitaxel|"Gemcitabine: 2500 milligrams per square meter (mg/m2), intravenous (IV), every 14 days x 8 cycles.~Paclitaxel: 150 mg/m2, IV, every 14 days x 8 cycles"
540276|NCT00191815|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540277|NCT00191815|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540278|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540279|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540280|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540281|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540282|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540283|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540284|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540285|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540286|NCT00191815|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540287|NCT00191815|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).~Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle)."
540288|NCT00191789|B1|Baseline|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540289|NCT00191789|P1|Participant Flow|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540290|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540291|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540368|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540745|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540292|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540293|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540294|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540295|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540296|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540297|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540298|NCT00191789|O1|Outcome|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540299|NCT00191789|E1|Reported Event|Gemcitabine+Doxorubicin+Cisplatin+Surgery|"Gemcitabine: 1200 mg/m^2, intravenous (IV) day 1 and day 8 every 21 days x 4 cycles (1-4) then 1000 mg/m^2, IV, day 1 and day 8 every 21 days x 4 cycles (5-8).~Doxorubicin: 60 mg/m^2, IV, every 21 days x 4 cycles (1-4). Cisplatin: 70 mg/m^2, IV, every 21 days x 4 cycles (5-8). Surgery follows 8 cycles of chemotherapy. Extent and type of surgery is guided by tumor size, physician and/or patient decision."
540300|NCT00191724|B6|Baseline|Total|Total of all reporting groups
540301|NCT00191724|B5|Baseline|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540302|NCT00191724|B4|Baseline|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540303|NCT00191724|B3|Baseline|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540304|NCT00191724|B2|Baseline|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540305|NCT00191724|B1|Baseline|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540306|NCT00191724|P5|Participant Flow|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540307|NCT00191724|P4|Participant Flow|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540308|NCT00191724|P3|Participant Flow|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540309|NCT00191724|P2|Participant Flow|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540310|NCT00191724|P1|Participant Flow|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540311|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540312|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540524|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540313|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540314|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540315|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540316|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540317|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540318|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540319|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540320|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540321|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540322|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540323|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540324|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540325|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540326|NCT00191724|O5|Outcome|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540327|NCT00191724|O4|Outcome|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540328|NCT00191724|O3|Outcome|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540329|NCT00191724|O2|Outcome|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540330|NCT00191724|O1|Outcome|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540331|NCT00191724|E5|Reported Event|Placebo|Placebo: intravenous (IV), one infusion, over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540332|NCT00191724|E4|Reported Event|Drotrecogin Alfa (Activated) - 24|Drotrecogin alfa (activated): 24 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540333|NCT00191724|E3|Reported Event|Drotrecogin Alfa (Activated) - 18|Drotrecogin alfa (activated): 18 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540334|NCT00191724|E2|Reported Event|Drotrecogin Alfa (Activated) - 12|Drotrecogin alfa (activated): 12 ug/kg/hr intravenous (IV), one infusion over 12 hours Enoxaparin: 1 mg/kg, subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540335|NCT00191724|E1|Reported Event|Drotrecogin Alfa (Activated) - 6|Drotrecogin alfa (activated): 6 micrograms/kilograms/hour (ug/kg/hr) intravenous (IV), one infusion over 12 hours Enoxaparin: 1 milligram/kilogram (mg/kg), subcutaneous, every 12 hours until the target international normalized ratio (INR) is reached, minimum of 5 days
540336|NCT00191646|B3|Baseline|Total|Total of all reporting groups
540337|NCT00191646|B2|Baseline|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
540369|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540525|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540338|NCT00191646|B1|Baseline|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
540339|NCT00191646|P2|Participant Flow|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
540340|NCT00191646|P1|Participant Flow|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
540341|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
540342|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
540343|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
540344|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
540345|NCT00191646|O4|Outcome|Paclitaxel (Crossover)|Crossover (From Gemcitabine to Paclitaxel) - If no complete response on Gemcitabine, patient crossed over to receive Paclitaxel 175 mg/m^2, IV, day 1, q 21 days until complete response, disease progression or unacceptable toxicity
540346|NCT00191646|O3|Outcome|Gemcitabine (Crossover)|Crossover (From Paclitaxel to Gemcitabine) - If no complete response on Paclitaxel, patient crossed over to receive Gemcitabine 1000 mg/m^2, IV, day 1 and day 8 q 21 days until complete response, disease progression or unacceptable toxicity
540347|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin (Induction)|Paclitaxel 175 milligrams per meter square (mg/m^2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, six 21-day cycles
540348|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin (Induction)|Gemcitabine 1000 milligrams per meter square (mg/m^2) Day 1, Day 8, Carboplatin AUC 5 Day 1, six 21-day cycles
540349|NCT00191646|O2|Outcome|Paclitaxel/Carboplatin|"Induction: Paclitaxel 175 mg/m^2 and Carboplatin AUC 6 Day 1, every 21 days. Consolidation (paclitaxel to paclitaxel): Paclitaxel 135 mg/m^2 IVPB, 3 hours every 28 days for 12 cycles (one year).~Gemcitabine (crossover): Single agent Gemcitabine 1000 mg/m^2 days 1, 8 to be repeated every 21 days."
540350|NCT00191646|O1|Outcome|Gemcitabine/Carboplatin|"Induction: Gemcitabine 1000 mg/m^2 Days 1 and 8 followed by Carboplatin Area Under the Curve (AUC) 5 Day 1; every 21-days.~Consolidation (gemcitabine to paclitaxel): Paclitaxel 135 mg/m^2 Intravenous Piggy-Back (IVPB), 3 hours every 28 days for 12 cycles (one year).~Paclitaxel (crossover): Single agent Paclitaxel 175 mg/m^2 day 1 to be repeated every 21 days."
540351|NCT00191646|E6|Reported Event|Crossover (Gemcitabine to Paclitaxel)|Single agent Paclitaxel 175mg/m2 IV Day 1 to be repeated every 21 days.
540352|NCT00191646|E5|Reported Event|Crossover (Paclitaxel to Gemcitabine)|Single agent Gemcitabine 1000mg/m2 IV, Day 1, Day 8 to be repeated every 21 days.
540353|NCT00191646|E4|Reported Event|Consolidation (Paclitaxel to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
540354|NCT00191646|E3|Reported Event|Consolidation (Gemcitabine to Paclitaxel)|Paclitaxel 135mg/m2 IV/3 hours every 28 days for 12 cycles (one year).
540355|NCT00191646|E2|Reported Event|Paclitaxel/Carboplatin Induction|Paclitaxel 175 milligrams per meter square (mg/m2) administered intravenously (IV) Day 1 Carboplatin AUC 6 Day 1, 6 21 day cycles
540356|NCT00191646|E1|Reported Event|Gemcitabine/Carboplatin Induction|Gemcitabine 1000 milligrams per meter square (mg/m2) Day 1, Day 8, Carboplatin AUC 5 Day 1, 6 21 day cycles
540357|NCT00191477|B3|Baseline|Total|Total of all reporting groups
540358|NCT00191477|B2|Baseline|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540359|NCT00191477|B1|Baseline|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540360|NCT00191477|P2|Participant Flow|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540361|NCT00191477|P1|Participant Flow|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540362|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540363|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540364|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540365|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540366|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540367|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540869|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540371|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540372|NCT00191477|O2|Outcome|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540373|NCT00191477|O1|Outcome|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of the bladder tumor (TUR-BT)
540374|NCT00191477|E2|Reported Event|Placebo|Placebo: intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
540375|NCT00191477|E1|Reported Event|Gemcitabine|Gemcitabine: 2000 mg, intravesicular instillation x 1 immediately post transurethral resection of bladder tumor (TUR-BT)
540376|NCT00191451|B4|Baseline|Total|Total of all reporting groups
540377|NCT00191451|B3|Baseline|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540378|NCT00191451|B2|Baseline|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540379|NCT00191451|B1|Baseline|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540380|NCT00191451|P3|Participant Flow|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540381|NCT00191451|P2|Participant Flow|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540382|NCT00191451|P1|Participant Flow|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540383|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540384|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540385|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540386|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540387|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540388|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540389|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540409|NCT00191334|P1|Participant Flow|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540390|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540391|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540392|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540393|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540394|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540395|NCT00191451|O3|Outcome|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540396|NCT00191451|O2|Outcome|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540397|NCT00191451|O1|Outcome|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540398|NCT00191451|E3|Reported Event|HER2- (Taxane+)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-pretreated patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540399|NCT00191451|E2|Reported Event|HER2- (Taxane-)|"Human Epidermal growth factor Receptor 2 negative: Gemcitabine + Carboplatin. (Taxane-naive patients).~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion)."
540400|NCT00191451|E1|Reported Event|HER2+|"Human Epidermal growth factor Receptor 2 positive: Gemcitabine + Carboplatin + Herceptin.~Gemcitabine: Day 1 of 14 day cycle (Cycles 1-9):1500 milligram per square meter (mg/m2) intravenous (IV) (30 minute infusion); Carboplatin: Day 1 of 14 day cycle (Cycles 1-9): Carboplatin area under the curve (AUC)=2.5 intravenous (IV) (30-60 minute infusion); Herceptin: Day 1 of 14 day cycle (Cycle 1): 8 milligrams per kilogram (mg/kg) intravenous (IV) (90 minute infusion). Day 1 of 14 day cycle (Cycles 2-9): 4 mg/kg IV (30 minute infusion). Day 1 of 21 day cycle (Cycles 10+): 6 mg/kg IV (30 minute infusion)."
540401|NCT00191386|B1|Baseline|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540402|NCT00191386|P1|Participant Flow|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540403|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540404|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540405|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540406|NCT00191386|O1|Outcome|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540407|NCT00191386|E1|Reported Event|Atomoxetine|0.5 milligrams per kilogram (mg/kg) twice daily (BID), orally (PO) titrated to 1.2 mg/kg BID, PO over 2 weeks then 1.2 to 1.8 mg/kg BID, PO for 6 months and up to 4 years
540408|NCT00191334|B1|Baseline|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540519|NCT00191165|B3|Baseline|Total|Total of all reporting groups
540520|NCT00191165|B2|Baseline|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540410|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540411|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540412|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540413|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540414|NCT00191334|O1|Outcome|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540415|NCT00191334|E1|Reported Event|Gemcitabine + Cisplatin|"Gemcitabine: 1250 mg/m2, intravenous (IV) day 1 and day 8, every 21 days x 6 cycles or disease progression or unacceptable toxicity.~Cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 6 cycles or disease progression or unacceptable toxicity."
540416|NCT00191308|B1|Baseline|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540417|NCT00191308|P1|Participant Flow|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540418|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540419|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540420|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540421|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540422|NCT00191308|O1|Outcome|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540423|NCT00191308|E1|Reported Event|Pemetrexed + Cisplatin|"Pemetrexed: 500 milligram per square meter (mg/m^2) intravenous (IV) every 21 days (q 21 days) for 3 cycles unless disease progression occurs.~Cisplatin: 75 mg/m^2 IV q 21 days for 3 cycles unless disease progression occurs."
540424|NCT00191282|B3|Baseline|Total|Total of all reporting groups
540425|NCT00191282|B2|Baseline|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540426|NCT00191282|B1|Baseline|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540427|NCT00191282|P2|Participant Flow|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540428|NCT00191282|P1|Participant Flow|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540429|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540430|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540431|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540432|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540433|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540434|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540435|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540436|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540437|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540438|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540439|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540440|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540441|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540442|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540443|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540444|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540445|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540446|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540447|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540521|NCT00191165|B1|Baseline|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540448|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540449|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540450|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540451|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540452|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540453|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540454|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540455|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540456|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540457|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540458|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540459|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540460|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540461|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540462|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540463|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540522|NCT00191165|P2|Participant Flow|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540464|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540465|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540466|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540467|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540468|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540469|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540470|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540471|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540472|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540473|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540474|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540475|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540476|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540477|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540478|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540479|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540523|NCT00191165|P1|Participant Flow|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540480|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540481|NCT00191282|O2|Outcome|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540482|NCT00191282|O1|Outcome|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540483|NCT00191282|E2|Reported Event|Fasting|Human insulin isophane suspension: injected subcutaneous (SC) twice daily before the morning and evening meals until patient completes study; Insulin glargine: injected subcutaneous (SC) once daily in the evening until patient completes study; or Human insulin 30/70: Patient adjusted dose, twice daily before the morning and evening meals, injected subcutaneous (SC) until patient completes study. To replace insulin regimen in this arm only if patient has two consecutive HbA1c values >8.0%.
540484|NCT00191282|E1|Reported Event|Postprandial|Insulin lispro: Patient adjusted dose, three times a day (TID), injected subcutaneous (SC) before each meal until patient completes study; Human insulin isophane suspension: Patient adjusted dose, daily at bedtime, injected subcutaneous (SC) until patient completes study. To be added to the arm only if patient has two consecutive HbA1c values >8.0%.
540485|NCT00191269|B3|Baseline|Total|Total of all reporting groups
540486|NCT00191269|B2|Baseline|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540487|NCT00191269|B1|Baseline|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540488|NCT00191269|P2|Participant Flow|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540489|NCT00191269|P1|Participant Flow|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540490|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
540491|NCT00191269|O1|Outcome|Dose Normalized to 1250 Milligrams Per Square Meter|12 participants with a mean gemcitabine dose of 1120 milligrams per square meter
540492|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540493|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540494|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540495|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540496|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540497|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540498|NCT00191269|O2|Outcome|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540499|NCT00191269|O1|Outcome|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540500|NCT00191269|E2|Reported Event|Dose Level 2|Gemcitabine at 1250 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540501|NCT00191269|E1|Reported Event|Dose Level 1|Gemcitabine at 1000 mg/m2 administered intravenously over 30 to 60 minutes on Days 1 and 8 in each 3-week (21-day) cycle of study therapy.
540502|NCT00191191|B3|Baseline|Total|Total of all reporting groups
540503|NCT00191191|B2|Baseline|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540504|NCT00191191|B1|Baseline|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540505|NCT00191191|P2|Participant Flow|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540506|NCT00191191|P1|Participant Flow|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540507|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540508|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540509|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540510|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540511|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540512|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540513|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540514|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540515|NCT00191191|O2|Outcome|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540516|NCT00191191|O1|Outcome|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540517|NCT00191191|E2|Reported Event|Pemetrexed 1000 mg/m2|Pemetrexed 1000 mg/m2, intravenous, every 21 days
540518|NCT00191191|E1|Reported Event|Pemetrexed 500 mg/m2|Pemetrexed 500 mg/m2, intravenous, every 21 days
540526|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540527|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540528|NCT00191165|O2|Outcome|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540529|NCT00191165|O1|Outcome|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540530|NCT00191165|E2|Reported Event|Label Dose Somatropin|Somatropin: 0.025 to 0.035 milligram/kilogram/day subcutaneous injection
540531|NCT00191165|E1|Reported Event|High Dose Somatropin|Somatropin: 0.05 to 0.07 milligram/kilogram/day subcutaneous injection
540532|NCT00191152|B3|Baseline|Total|Total of all reporting groups
540533|NCT00191152|B2|Baseline|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID),Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
540534|NCT00191152|B1|Baseline|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO)twice a day (BID), Days 1-14, every 21 days until progressive disease (PD) at which time all treatment is discontinued."
540535|NCT00191152|P2|Participant Flow|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
540536|NCT00191152|P1|Participant Flow|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2),intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued. PD during crossover was defined as the Response Evaluation Criteria in Solid Tumors (RECIST) guideline with the tumor measurement at the start of crossover treatment (or end of initial treatment) considered as the crossover baseline, with subsequent tumor measurements during crossover treatment compared to the crossover baseline."
540537|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
540538|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth twice day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
540539|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth, twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540540|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, on Day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540541|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2 intravenously, days 1 and 8, every 21 days
540542|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14, every 21 days
540543|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540544|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540545|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
540546|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
540547|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540548|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540549|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540550|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days. Treatment continues until progression of disease at which time crossover treatment begins.
540551|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
540552|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
540553|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540744|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540554|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540555|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14 every 21 days. Treatment continues until progression of disease, at which time crossover treatment begins.
540556|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|"gemcitabine 1000 milligrams per meter squared (mg/m2) intravenous, days 1 and 8 every 21 days plus docetaxel 75 mg/m2, intravenous, day 1 every 21 days.~Treatment continues until progression of disease at which time crossover treatment begins."
540557|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
540558|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
540559|NCT00191152|O2|Outcome|Docetaxel Plus Capecitabine|docetaxel 75 mg/m2, intravenous, on day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth twice a day, days 1-14, every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540560|NCT00191152|O1|Outcome|Gemcitabine Plus Docetaxel|gemcitabine 1000 mg/m2, intravenous on days 1 and 8 every 21 days plus docetaxel 75 mg/m2 intravenous on day 1 every 21 days. This treatment continues until progression of disease at which time crossover treatment begins.
540561|NCT00191152|O2|Outcome|Gemcitabine|gemcitabine 1000 mg/m2, intravenous, days 1 and 8 every 21 days until progression of disease at which time all treatment is discontinued.
540562|NCT00191152|O1|Outcome|Capecitabine|capecitabine 1000 mg/m2, by mouth two times per day, days 1-14 every 21 days until progression of disease at which time all treatment is discontinued.
540563|NCT00191152|E2|Reported Event|Docetaxel Plus Capecitabine|"Initial treatment: Docetaxel 75 milligrams per meter squared (mg/m2), intravenous (IV) on Day 1 every 21 days plus capecitabine 1000 mg/m2, by mouth (PO), twice a day (BID), Days 1-14, every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: gemcitabine 1000 mg/m2, IV, Days 1 and 8, every 21 days. This treatment continues until PD at which time all treatment is discontinued."
540564|NCT00191152|E1|Reported Event|Gemcitabine Plus Docetaxel|"Initial treatment: Gemcitabine 1000 milligrams per meter squared (mg/m2), intravenous (IV) on Days 1 and 8 every 21 days plus docetaxel 75 mg/m2 IV on Day 1 every 21 days. This treatment continues until progression of disease (PD), at which time crossover treatment begins.~Crossover treatment: capecitabine 1000 mg/m2 by mouth (PO) twice a day (BID), Days 1-14, every 21 days until PD at which time all treatment is discontinued."
540565|NCT00191139|B3|Baseline|Total|Total of all reporting groups
540566|NCT00191139|B2|Baseline|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540567|NCT00191139|B1|Baseline|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540568|NCT00191139|P2|Participant Flow|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540569|NCT00191139|P1|Participant Flow|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540570|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540571|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540572|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540573|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540574|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540575|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540576|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540577|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540578|NCT00191139|O2|Outcome|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540579|NCT00191139|O1|Outcome|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
541051|NCT00187135|B3|Baseline|Placebo/Fentanyl 0.5/Fentanyl 1|
540580|NCT00191139|E2|Reported Event|Gemcitabine Plus Docetaxel|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles; docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine.
540581|NCT00191139|E1|Reported Event|Gemcitabine|Consolidation Treatment: gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles
540582|NCT00191113|B3|Baseline|Total|Total of all reporting groups
540583|NCT00191113|B2|Baseline|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540584|NCT00191113|B1|Baseline|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540585|NCT00191113|P2|Participant Flow|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540586|NCT00191113|P1|Participant Flow|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540587|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540588|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540589|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540590|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540591|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
540592|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
540593|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540594|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540595|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540596|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540597|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
540598|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540599|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540600|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540601|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
540602|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540603|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540604|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540605|NCT00191113|O2|Outcome|Treated-As-Randomized Humatrope|Patients in As-Randomized Humatrope group who received Humatrope treatment
540606|NCT00191113|O1|Outcome|Treated-As-Randomized Control|Patients in As-Randomized Control group who at each observed time point remained untreated with growth hormone.
540607|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540608|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540609|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540610|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540611|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540612|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540613|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540614|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540615|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
540616|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540617|NCT00191113|O2|Outcome|As-Treated Growth Humatrope|Patients who received Humatrope or another brand of growth hormone
540618|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540619|NCT00191113|O2|Outcome|As-Treated Growth Hormone|Patients who received Humatrope or another brand of growth hormone
540620|NCT00191113|O1|Outcome|As-Treated No Growth Hormone|Patients who never received growth hormone
540621|NCT00191113|O2|Outcome|As-Randomized Humatrope|Humatrope (0.05 mg/kg/dose) by subcutaneous injection 6 times per week. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540622|NCT00191113|O1|Outcome|As-Randomized Control|Control arm; untreated with Humatrope. Ethinyl estradiol (escalating doses to 20 mcg daily) after age 13, and medroxyprogesterone acetate (10 mg tablets ten days monthly) after age 15. Subject continues until Core study completion criteria are met (protocol final height).
540623|NCT00191113|E2|Reported Event|Treated-As-Randomized Humatrope|Patients in the As-Randomized Humatrope group who received Humatrope
540624|NCT00191113|E1|Reported Event|Treated-As-Randomized Control|Patients in the As-Randomized Control group who at each observed time point remained untreated with growth hormone.
540625|NCT00191100|B3|Baseline|Total|Total of all reporting groups
540626|NCT00191100|B2|Baseline|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540627|NCT00191100|B1|Baseline|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540628|NCT00191100|P2|Participant Flow|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540629|NCT00191100|P1|Participant Flow|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540630|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540631|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540632|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540633|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540634|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540635|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540636|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540637|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540638|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540639|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540640|NCT00191100|O2|Outcome|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540641|NCT00191100|O1|Outcome|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540642|NCT00191100|E2|Reported Event|Cisplatin/Radiation|"Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week"
540643|NCT00191100|E1|Reported Event|Gemcitabine/Cisplatin/Radiation|"Gemcitabine: 125 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Cisplatin: 40 mg/m2, once weekly (QW), intravenous (IV), 6 weeks Pelvic radiation: 1.8 Gy/day, 5 days/week, 6 weeks~Brachytherapy, 30-35 Gy over 1 week~Two week rest period with no chemotherapy or radiation~Cisplatin, 50 mg/m2, IV, day 1 of 21 day cycle for two 21-day cycles and Gemcitabine, 1000 mg/m2, day 1 and day 8 for two 21 day cycles"
540644|NCT00190983|B1|Baseline|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540645|NCT00190983|P1|Participant Flow|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540646|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540647|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540648|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540649|NCT00190983|O1|Outcome|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540650|NCT00190983|E1|Reported Event|Pemetrexed|Pemetrexed: 900 mg/m2 (700 mg/m2 for patients with prior radiotherapy) intravenous (IV) over 10 minutes every 21 days until disease progression
540651|NCT00190775|B3|Baseline|Total|Total of all reporting groups
540652|NCT00190775|B2|Baseline|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540653|NCT00190775|B1|Baseline|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540654|NCT00190775|P2|Participant Flow|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540655|NCT00190775|P1|Participant Flow|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540656|NCT00190775|O3|Outcome|Atomoxetine|Atomoxetine for 24 weeks
540657|NCT00190775|O2|Outcome|Placebo/Atomoxetine Group 2|Placebo for 24 weeks followed by atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
540658|NCT00190775|O1|Outcome|Placebo/Atomoxetine Group 1|Placebo for 24 Weeks followed by atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
540659|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
540660|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
540661|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 11 days
540662|NCT00190775|O3|Outcome|Placebo|Placebo is administered once daily, orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine for 2 weeks then 40-100 mg/day
540663|NCT00190775|O2|Outcome|Atomoxetine Group 2|Atomoxetine 40 mg/day for 7 days followed by 80 mg/day for 7 days
540664|NCT00190775|O1|Outcome|Atomoxetine Group 1|Atomoxetine 40 milligrams (mg)/day for 3 days followed by 80 mg/day for 4 days
540665|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540666|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540667|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540668|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540669|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540670|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540671|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540672|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540673|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540674|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540675|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540676|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540677|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540678|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540679|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
541052|NCT00187135|B2|Baseline|Fentanyl 0.5/Fentanyl 1/Placebo|
540680|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540681|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540682|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540683|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540684|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540685|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540686|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540687|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540688|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540689|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540690|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540691|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540692|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540693|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540694|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540695|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540696|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540697|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540698|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540699|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540700|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540701|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540702|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540703|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540704|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540705|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540706|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540707|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540708|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540709|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540710|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540711|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540712|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540713|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540714|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540715|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540716|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540717|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540718|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540719|NCT00190775|O2|Outcome|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540720|NCT00190775|O1|Outcome|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540721|NCT00190775|E2|Reported Event|Placebo|Placebo is administered once daily (QD), orally for 24 weeks. At the end of 24 weeks, the placebo arm is titrated to atomoxetine 40 mg QD for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days, then 40-100 mg QD, orally
540722|NCT00190775|E1|Reported Event|Atomoxetine|Atomoxetine 40 milligrams (mg) once daily (QD) for 3 days followed by 80 mg QD for 11 days OR 40 mg QD for 7 days followed by 80 mg QD for 7 days then 60/80/100 mg as determined by the investigator up to 24 weeks, orally
540723|NCT00190749|B3|Baseline|Total|Total of all reporting groups
540724|NCT00190749|B2|Baseline|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540725|NCT00190749|B1|Baseline|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540726|NCT00190749|P2|Participant Flow|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540727|NCT00190749|P1|Participant Flow|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540728|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540729|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540730|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540731|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540732|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540733|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540734|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540735|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540736|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540737|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540738|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540739|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540740|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540741|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540742|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540743|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
541053|NCT00187135|B1|Baseline|Fentanyl 0.5/Placebo/Fentanyl 1|
540746|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540747|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540748|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540749|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540750|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540751|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540752|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540753|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540754|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540755|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540756|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540757|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540758|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540759|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540760|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540761|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540762|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540763|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540764|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540765|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540766|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540767|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540768|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540769|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540770|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540771|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540772|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540773|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540774|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540775|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540776|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540777|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540778|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540779|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540780|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540781|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540782|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540783|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540784|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540785|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540786|NCT00190749|O2|Outcome|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540787|NCT00190749|O1|Outcome|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540788|NCT00190749|E2|Reported Event|Risperidone|Risperidone, 2-6 mg, oral, capsules, twice daily (BID), 12 weeks.
540789|NCT00190749|E1|Reported Event|Olanzapine|Olanzapine, 5-20 mg, oral, capsules, daily, 12 weeks.
540790|NCT00190684|B1|Baseline|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540791|NCT00190684|P1|Participant Flow|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540792|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540793|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540794|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540795|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
543751|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
540796|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540797|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540798|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540799|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540800|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540801|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540802|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540803|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540804|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540805|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540806|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540807|NCT00190684|O1|Outcome|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540808|NCT00190684|E1|Reported Event|Atomoxetine|Atomoxetine-naive patients will have an acute titration to a stable dose, atomoxetine experienced patients whose therapy has been interrupted will be rapidly titrated to their previously established stable dose, and atomoxetine patients on a known stable dose may continue treatment at that dose.
540809|NCT00190671|B3|Baseline|Total|Total of all reporting groups
540810|NCT00190671|B2|Baseline|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540811|NCT00190671|B1|Baseline|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540812|NCT00190671|P2|Participant Flow|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540813|NCT00190671|P1|Participant Flow|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540814|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540815|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540816|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540817|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540818|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540819|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540820|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540821|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540822|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540823|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540824|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540825|NCT00190671|O1|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540826|NCT00190671|O2|Outcome|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540827|NCT00190671|O1|Outcome|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540828|NCT00190671|E2|Reported Event|Pemetrexed 1800mg/m2|Pemetrexed: 1800 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540829|NCT00190671|E1|Reported Event|Pemetrexed 600mg/m2|Pemetrexed: 600 mg/m2, intravenous, every 21 days x 8 cycles Cyclophosphamide: 600 mg/m2, intravenous, every 21 days x 8 cycles
540830|NCT00187720|B3|Baseline|Total|Total of all reporting groups
540831|NCT00187720|B2|Baseline|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
540832|NCT00187720|B1|Baseline|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
540833|NCT00187720|P2|Participant Flow|Organic Cation Transporter 2 (OCT2)-Reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
540834|NCT00187720|P1|Participant Flow|Organic Cation Transporter 2 (OCT2)-Variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
540835|NCT00187720|O2|Outcome|OCT2-reference Group|The renal clearance of metformin in subjects homozygous for the reference OCT2 genotype (808G/G) following a single oral dose of 850 mg of metformin.
540836|NCT00187720|O1|Outcome|OCT2-variant Group|The renal clearance of metformin in subjects heterozygous for the variant OCT2 genotype (808G/T, *3D) following a single oral dose of 850 mg of metformin.
540837|NCT00187720|E2|Reported Event|OCT2-variant Group|Subjects with OCT2-variant genotype will be given a single oral dose of 850 mg of metformin
540838|NCT00187720|E1|Reported Event|OCT2-reference Group|Subjects with OCT2-reference genotype will be given a single oral dose of 850 mg of metformin
540839|NCT00187681|B3|Baseline|Total|Total of all reporting groups
540840|NCT00187681|B2|Baseline|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
540841|NCT00187681|B1|Baseline|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
540842|NCT00187681|P2|Participant Flow|Organic Cation Transporter 1 (OCT1)-Reference Group|Subjects with OCT1-reference alleles to be dosed with 2 doses of Metformin (total 1850 mg).
540843|NCT00187681|P1|Participant Flow|Organic Cation Transporter 1 (OCT1)-Variant Group|Subjects with OCT1-variant alleles to be dosed with 2 doses of Metformin (total 1850 mg).
540844|NCT00187681|O2|Outcome|OCT1-reference Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying the reference OCT1 genotype at all the four positions in the OCT1 gene.
540845|NCT00187681|O1|Outcome|OCT1-variant Group|Glucose lowering response to metformin (Glucose AUC) in subjects carrying variant OCT1 genotypes (ie. carries at least one of four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
540846|NCT00187681|O2|Outcome|OCT1-reference Group|Metformin blood concentration-time profiles in subjects carrying the reference OCT1 allele at all the four positions in the OCT1 gene.
540847|NCT00187681|O1|Outcome|OCT1-variant Group|Metformin blood concentration-time profiles in subjects carrying the variant OCT1 genotypes (ie. carries at least one of the four variant alleles OCT1-R61C, G401S, 420del, and/or OCT1-G465R).
540848|NCT00187681|E2|Reported Event|OCT1-reference Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
540849|NCT00187681|E1|Reported Event|OCT1-variant Group|Subjects with OCT1-reference alleles to be doses with 2 doses of Metformin (total 1850 mg).
540850|NCT00187655|B1|Baseline|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
540851|NCT00187655|P1|Participant Flow|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
540852|NCT00187655|O2|Outcome|Homozygous for OAT3-Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as homozygous for the Ile305Phe variant and compared to volunteers that were heterozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
540853|NCT00187655|O1|Outcome|Heterozygous for the Ile305Phe Variant|2 grams of Cefotaxime was administered as a single IV push of 2 grams over 5 minutes into healthy individuals that were identified as heterozygous for the Ile305Phe variant and compared to volunteers that were homozygous for the reference allele. Renal clearance and net secretory component of cefotaxime renal clearance (CLsec ) were analyzed.
540854|NCT00187655|E1|Reported Event|Cefotaxime|Cefotaxime will be administered as a single IV push of 2 grams over 5 minutes.
540855|NCT00189540|B3|Baseline|Total|Total of all reporting groups
540856|NCT00189540|B2|Baseline|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540857|NCT00189540|B1|Baseline|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540858|NCT00189540|P2|Participant Flow|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540859|NCT00189540|P1|Participant Flow|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540860|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540861|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540862|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540863|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540864|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540865|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540866|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540867|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540868|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540870|NCT00189540|O2|Outcome|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540871|NCT00189540|O1|Outcome|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540872|NCT00189540|E2|Reported Event|Placebo Group|Placebo (saline)via IM injections on days 0, 14, and 28
540873|NCT00189540|E1|Reported Event|Active Group|4.0 mg AMG0001 via IM injections on days 0, 14, and 28
540874|NCT00189488|B3|Baseline|Total|Total of all reporting groups
540875|NCT00189488|B2|Baseline|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540876|NCT00189488|B1|Baseline|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540877|NCT00189488|P2|Participant Flow|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg. Participants received conditioning therapy starting at least 24 hours after the last 60 μg dose of palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the 180 μg/kg dose of palifermin on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively
540878|NCT00189488|P1|Participant Flow|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin once prior to transplant and at least 96 hours from the previous placebo dose. Participants received conditioning therapy starting at least 24 hours after the last 60 μg/kg dose of placebo to palifermin. Allogeneic stem cell transplant occurred on Day 0. Methotrexate dosing began at least 24 hours after the dose of placebo to palifermin 180 μg/kg on Days 1, 3, 6 and (planned) 11 administration (toxicity allowing) at doses of 15, 10, 10 and 10 mg/m^2 respectively.
540879|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540880|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540881|NCT00189488|O2|Outcome|Palifermin|PaPalifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540882|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540883|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540884|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540885|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540886|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540887|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540888|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540889|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540890|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540891|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540892|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540893|NCT00189488|O2|Outcome|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
540894|NCT00189488|O1|Outcome|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540895|NCT00189488|E2|Reported Event|Palifermin|Palifermin 60 μg/kg administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and 180 μg/kg administered once prior to transplant and at least 96 hours from last palifermin dose of 60 μg/kg.
541151|NCT00186901|O2|Outcome|Non-white|59 non-white were eligible for the study
540896|NCT00189488|E1|Reported Event|Placebo|Placebo to 60 μg/kg palifermin administered daily on 3 consecutive days prior to the day of start of the conditioning regimen and placebo to 180 μg/kg palifermin administered once, prior to transplant and at least 96 hours from the previous placebo dose.
540897|NCT00189475|B3|Baseline|Total|Total of all reporting groups
540898|NCT00189475|B2|Baseline|Placebo|Treated for 4 months with placebo
540899|NCT00189475|B1|Baseline|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
540900|NCT00189475|P2|Participant Flow|Placebo|Treated for 4 months with placebo
540901|NCT00189475|P1|Participant Flow|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
540902|NCT00189475|O2|Outcome|Placebo|Treated for 6 days with placebo
540903|NCT00189475|O1|Outcome|Montelukast|Montelukast 10mg per day for 6 days
540904|NCT00189475|E2|Reported Event|Placebo|Treated for 4 months with placebo
540905|NCT00189475|E1|Reported Event|Montelukast|"Treated for 4 months with montelukast 4 mg per day~Montelukast"
540906|NCT00189462|B3|Baseline|Total|Total of all reporting groups
540907|NCT00189462|B2|Baseline|Placebo|Treatment with placebo for 4 months
540908|NCT00189462|B1|Baseline|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
540909|NCT00189462|P2|Participant Flow|Placebo|Treatment with placebo for 4 months
540910|NCT00189462|P1|Participant Flow|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
540911|NCT00189462|O2|Outcome|Placebo|Treatment with placebo for 4 months
540912|NCT00189462|O1|Outcome|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
540913|NCT00189462|E2|Reported Event|Placebo|Treatment with placebo for 4 months
540914|NCT00189462|E1|Reported Event|Montelukast|"Treatment with montelukast for 4 months (4 mg per day)~Montelukast"
540915|NCT00189436|B3|Baseline|Total|Total of all reporting groups
540916|NCT00189436|B2|Baseline|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
540917|NCT00189436|B1|Baseline|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
540918|NCT00189436|P2|Participant Flow|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
540919|NCT00189436|P1|Participant Flow|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
540920|NCT00189436|O2|Outcome|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
540921|NCT00189436|O1|Outcome|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
540922|NCT00189436|E2|Reported Event|Usual Care|"Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.~Usual care (albuterol with or without oral steroid): Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)"
540923|NCT00189436|E1|Reported Event|Treatment With Budesonide|"Subject is treated with nebulized budesonide 0.5 BID for 3 weeks~Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks"
540924|NCT00189423|B3|Baseline|Total|Total of all reporting groups
540925|NCT00189423|B2|Baseline|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540926|NCT00189423|B1|Baseline|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540927|NCT00189423|P2|Participant Flow|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540928|NCT00189423|P1|Participant Flow|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540929|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540930|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540931|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540932|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540933|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540934|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540935|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540936|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540937|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540938|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540939|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540940|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540941|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540942|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540943|NCT00189423|O2|Outcome|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540944|NCT00189423|O1|Outcome|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
541152|NCT00186901|O1|Outcome|White|365 white patients were eligible for the study
540945|NCT00189423|E2|Reported Event|ACD CPR Plus ITD|Active compression decompression CPR plus an Impedance Threshold Device
540946|NCT00189423|E1|Reported Event|Standard CPR|Conventional standard cardiopulmonary resuscitation (S-CPR)
540947|NCT00189306|B1|Baseline|Aldara|Aldara (imiquimod) cream 5%
540948|NCT00189306|P1|Participant Flow|Aldara|Aldara (imiquimod) cream 5%
540949|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
540950|NCT00189306|O1|Outcome|Aldara|Aldara (imiquimod) cream 5%
540951|NCT00189306|E1|Reported Event|Aldara|Aldara (imiquimod) cream 5%
540952|NCT00189137|B3|Baseline|Total|Total of all reporting groups
540953|NCT00189137|B2|Baseline|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540954|NCT00189137|B1|Baseline|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540955|NCT00189137|P2|Participant Flow|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540956|NCT00189137|P1|Participant Flow|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540957|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540958|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540959|NCT00189137|O2|Outcome|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540960|NCT00189137|O1|Outcome|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540961|NCT00189137|E2|Reported Event|Gemcitabine and Docetaxel|"Arm 2 will consist of the two drug combination of gemcitabine (day 1, 8) and docetaxel (day 8) repeated at 21 day intervals. Patients will receive filgrastim as a myeloid growth factor days 9-15 or peg-filgrastim on day 4.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540962|NCT00189137|E1|Reported Event|Doxorubicin and Ifosfamide|"Arm 1 will consist of the two drug combination of doxorubicin and ifosfamide (with mesna) Treatment will be delivered over 3 days at 21 day intervals. Patients will receive filgrastim days 4-10 or peg-filgrastim on day 4 as a myeloid growth factor.~All patients will receive 4 cycles of chemotherapy unless there is unacceptable toxicity or disease progression that may adversely impact the surgical plan for complete resection."
540963|NCT00189098|B3|Baseline|Total|Total of all reporting groups
540964|NCT00189098|B2|Baseline|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
540965|NCT00189098|B1|Baseline|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
540966|NCT00189098|P2|Participant Flow|Sulfamethoxazole-trimethoprim|Children assigned to the Sulfamethoxazole-trimethoprim group received Sulfamethoxazole-trimethoprim orally (18mg/kg two times a day) for 6 to 12 weeks. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
540967|NCT00189098|P1|Participant Flow|Placebo|Children assigned to the placebo group received two times a day a placebo for 6 to 12 weeks. The placebo was a blinded suspension with an identical taste, bottle and fluid appearance as the sulfamethoxazole-trimethoprim suspension. When at the first control visit after 6 weeks otorrhea was found to be present in either ear, the study medication was continued for another 6 weeks. The study medication was discontinued if both ears were found to be free from otorrhea and parents confirmed that they had seen no signs of otorrhea during the previous week. Parents were instructed to start the study medication again if symptoms of otorrhea recurred between the follow-up visits at 6 and 12 weeks. At inclusion and if otorrhea was present at 6 and 12 weeks follow-up, antibiotic with corticosteroid eardrops were prescribed in addition to the study medication for 7 to 10 days. After 12 weeks follow-up the study medication was discontinued irrespective of the presence or absence of otorrhea.
540968|NCT00189098|O2|Outcome|Placebo|
540969|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
540970|NCT00189098|O2|Outcome|Placebo|
540971|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
540972|NCT00189098|O2|Outcome|Placebo|
540973|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
540974|NCT00189098|O2|Outcome|Placebo|
540975|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
540976|NCT00189098|O2|Outcome|Placebo|
540977|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|
540978|NCT00189098|O2|Outcome|Placebo|The children in this group received placebo orally two times a day for 6 to 12 weeks.
540979|NCT00189098|O1|Outcome|Sulfamethoxazole-trimethoprim|The children in this group received Sulfamethoxazole-trimethoprim orally (18 mg/kg, two times a day) for 6 to 12 weeks.
540980|NCT00189098|E2|Reported Event|Placebo|
540981|NCT00189098|E1|Reported Event|Sulfamethoxazole-trimethoprim|
540982|NCT00187889|B3|Baseline|Total|Total of all reporting groups
540983|NCT00187889|B2|Baseline|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
540984|NCT00187889|B1|Baseline|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
540985|NCT00187889|P2|Participant Flow|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
540986|NCT00187889|P1|Participant Flow|Eplerenone|Eplerenone 25 mg (1 pill) daily for 1 week then uptitrated to 50 mg (2 pills) daily for 15 weeks.
540987|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
540988|NCT00187889|O1|Outcome|EPLERENONE|Active Drug
540989|NCT00187889|O2|Outcome|PLACEBO|Inert Placebo
540990|NCT00187889|O1|Outcome|EPLERINONE|Active drug
540991|NCT00187889|E2|Reported Event|Placebo or Sugar Pill|Placebo blinded as 25 mg tablet once daily for 1 week then uptitrated to 2 pills daily for 15 weeks.
540992|NCT00187889|E1|Reported Event|Epleranone|Epleranone 25 mg daily for 1 week then uptitrated to 50 mg daily for 15 weeks.
540993|NCT00187876|B3|Baseline|Total|Total of all reporting groups
540994|NCT00187876|B2|Baseline|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
540995|NCT00187876|B1|Baseline|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
540996|NCT00187876|P2|Participant Flow|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
540997|NCT00187876|P1|Participant Flow|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts that are non- irradiated aseptically, processed BTB allografts."
540998|NCT00187876|O2|Outcome|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
540999|NCT00187876|O1|Outcome|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using aseptic patellar tendon allografts."
541000|NCT00187876|E2|Reported Event|ACL Biocleanse, Surgical|"The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process.~ACL Biocleanse, surgical: The intervention consists of the surgical reconstruction of the ACL ligament using patellar tendon allografts that have undergone the BioCleanse™ process."
541001|NCT00187876|E1|Reported Event|ACL Reconstruction Control|"The intervention consists of the reconstruction of the ACL ligament using patellar tendon allografts.~ACL reconstruction control: The intervention consists of the reconstruction of the ACL ligament using asceptic patellar tendon allografts."
541002|NCT00187486|B1|Baseline|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
541003|NCT00187486|P1|Participant Flow|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
541004|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
541005|NCT00187486|O1|Outcome|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
541006|NCT00187486|E1|Reported Event|Temodar Plus Tarceva Plus Radiotherapy|All patients were treated with radiotherapy and temozolomide; patients were treated with dosing of tarceva based upon use of enzyme-inducing antiepileptic drugs
541007|NCT00187226|B7|Baseline|Total|Total of all reporting groups
541008|NCT00187226|B6|Baseline|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
541009|NCT00187226|B5|Baseline|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
541010|NCT00187226|B4|Baseline|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
541011|NCT00187226|B3|Baseline|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
541012|NCT00187226|B2|Baseline|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
541013|NCT00187226|B1|Baseline|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
541014|NCT00187226|P6|Participant Flow|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
541015|NCT00187226|P5|Participant Flow|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
541016|NCT00187226|P4|Participant Flow|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
541017|NCT00187226|P3|Participant Flow|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
541018|NCT00187226|P2|Participant Flow|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
541019|NCT00187226|P1|Participant Flow|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
541020|NCT00187226|O6|Outcome|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
541021|NCT00187226|O5|Outcome|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
541022|NCT00187226|O4|Outcome|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
541023|NCT00187226|O3|Outcome|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
541024|NCT00187226|O2|Outcome|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
541025|NCT00187226|O1|Outcome|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
541026|NCT00187226|E6|Reported Event|2cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 2cm clinical target volume margin group.
541027|NCT00187226|E5|Reported Event|2cm Clinical Target Volume Margin - High-grade Glioma|Patients with High-grade glioma in the 2cm clinical target volume margin group.
541028|NCT00187226|E4|Reported Event|1cm Clinical Target Volume Margin - Other|Remaining patients in the 1cm clinical target volume margin group.
541029|NCT00187226|E3|Reported Event|1cm Clinical Target Volume Margin - Craniopharyngioma|Patients with Craniopharyngioma in the 1cm clinical target volume margin group.
541030|NCT00187226|E2|Reported Event|1cm Clinical Target Volume Margin - Low-grade Glioma|Patients with Low-grade Glioma in the 1cm clinical target volume margin group.
541031|NCT00187226|E1|Reported Event|1cm Clinical Target Volume Margin - Ependymoma|Patients with Ependymoma in the 1cm clinical target volume margin group.
541032|NCT00187200|B3|Baseline|Total|Total of all reporting groups
541033|NCT00187200|B2|Baseline|Sequential VV Pacing|V-V delay was optimized
541034|NCT00187200|B1|Baseline|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541035|NCT00187200|P2|Participant Flow|Sequential VV Pacing|V-V delay was optimized
541036|NCT00187200|P1|Participant Flow|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541037|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
541038|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541039|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
541040|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541041|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized
541042|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541043|NCT00187200|O2|Outcome|Sequential VV Pacing|V-V delay was optimized per protocol
541044|NCT00187200|O1|Outcome|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay per protocol
541045|NCT00187200|E2|Reported Event|Sequential VV Pacing|V-V delay was optimized
541046|NCT00187200|E1|Reported Event|Simultaneous Pacing V-V Timing|Patients maintained on simultaneous V-V delay
541047|NCT00187135|B7|Baseline|Total|Total of all reporting groups
541048|NCT00187135|B6|Baseline|Fentanyl 1/Placebo/Fentanyl 0.5|
541049|NCT00187135|B5|Baseline|Fentanyl 1/Fentanyl 0.5/Placebo|
541050|NCT00187135|B4|Baseline|Placebo/Fentanyl 1/Fentanyl 0.5|
541054|NCT00187135|P6|Participant Flow|Fentanyl 1 / Placebo /Fentanyl 0.5|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Placebo during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
541055|NCT00187135|P5|Participant Flow|Fentanyl 1 / Fentanyl 0.5 / Placebo|Participants assigned to receive Fentanyl 1 micrograms per kilogram (mcg/kg) during their first visit Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
541056|NCT00187135|P4|Participant Flow|Placebo /Fentanyl 1 / Fentanyl 0.5|Participants assigned to receive Placebo during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 0.5 micrograms per kilogram (mcg/kg) at the final visit.
541057|NCT00187135|P3|Participant Flow|Placebo / Fentanyl 0.5 /Fentanyl 1|Participants assigned to receive Placebo during their first visit, Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their second visit, and Fentanyl 1 micrograms per kilogram (mcg/kg) at the final visit.
541058|NCT00187135|P2|Participant Flow|Fentanyl 0.5 /Fentanyl 1 / Placebo|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Fentanyl 1 micrograms per kilogram (mcg/kg) during their second visit, and Placebo at the final visit.
541059|NCT00187135|P1|Participant Flow|Fentanyl 0.5 / Placebo / Fentanyl 1|Participants assigned to receive Fentanyl 0.5 micrograms per kilogram (mcg/kg) during their first visit, Placebo (Pl)during their second visit, and Fentanyl 1 micrograms per kilogram at the final visit.
541060|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
541061|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541062|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541063|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm.
541064|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541065|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541066|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
541067|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541068|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541069|NCT00187135|O3|Outcome|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
541070|NCT00187135|O2|Outcome|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541071|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541072|NCT00187135|O1|Outcome|Fentanyl 0.5mcg/kg vs Fentanyl 1mcg/kg|Patients who completed treatment with Fentanyl 0.5 mcg/kg and Fentanyl 1mcg/kg.
541073|NCT00187135|O2|Outcome|Fentanyl 0.5mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 0.5 mcg/kg and placebo.
541074|NCT00187135|O1|Outcome|Fentanyl 1mcg/kg vs Placebo|Patients who completed treatment with Fentanyl 1 mcg/kg and placebo.
541075|NCT00187135|E3|Reported Event|Placebo|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Placebo are included in this arm. Participants were included regardless of whether they received other treatments.
541076|NCT00187135|E2|Reported Event|Fentanyl 1mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 1.0 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541077|NCT00187135|E1|Reported Event|Fentanyl 0.5mcg/kg|Due to study termination, not all Participants completed three planned visits. Participants who completed at least one treatment with Fentanyl 0.5 mcg/kg are included in this arm. Participants were included regardless of whether they received other treatments.
541078|NCT00187096|B4|Baseline|Total|Total of all reporting groups
541079|NCT00187096|B3|Baseline|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541080|NCT00187096|B2|Baseline|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541081|NCT00187096|B1|Baseline|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541082|NCT00187096|P3|Participant Flow|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2.0 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541083|NCT00187096|P2|Participant Flow|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541084|NCT00187096|P1|Participant Flow|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|Participants with AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Arm 1 participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541085|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541086|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541087|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541088|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541089|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541090|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541091|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541092|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541093|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541094|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541095|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541096|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541153|NCT00186901|O2|Outcome|Female|206 females were eligible for the study
541097|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541098|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541099|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541100|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541101|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541102|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541103|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541104|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541105|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541106|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541107|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541108|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541109|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541110|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541111|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541150|NCT00186901|O1|Outcome|9 to 13 Years|98 patients between the ages of 9 and 13 were eligible for the study
541112|NCT00187096|O3|Outcome|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541113|NCT00187096|O2|Outcome|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541114|NCT00187096|O1|Outcome|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541115|NCT00187096|E3|Reported Event|Arm 2b: Conditioning: Clofarabine/Etoposide/Cyclophosphamide|AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD) (stratum 2). Participants enrolled after protocol Amendment 2 received a novel conditioning regimen of clofarabine, etoposide and cyclophosphamide prior to NK cell transplantation.
541116|NCT00187096|E2|Reported Event|Arm 2a: Conditioning Regimen: Cyclophosphamide/Fludarabine|"AML that is refractory or relapsed or AML with increasing minimal residual disease (MRD). Participants enrolled prior to Amendment 2.0 received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.~Refractory: ≥ 20% leukemic blasts in the bone marrow or no decrease in the percentage of blasts in the bone marrow (e.g., if a patient starts with 15% blasts and still has 15% blasts, he would have refractory disease).~Relapse: presence of ≥ 20% leukemic blasts in the bone marrow or the development of extramedullary disease after CR is achieved.~Increasing Minimal Residual Disease (MRD) indicates higher MRD levels."
541117|NCT00187096|E1|Reported Event|Arm 1: Conditioning Regimen: Cyclophosphamide/Fludarabine|AML in complete remission (stratum 1). AML in complete remission is defined as trilineage hematopoietic recovery with less than 5% blasts in the marrow. Participants received a traditional conditioning regimen of cyclophosphamide and fludarabine prior to NK cell transplantation.
541118|NCT00186901|B4|Baseline|Total|Total of all reporting groups
541119|NCT00186901|B3|Baseline|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
541120|NCT00186901|B2|Baseline|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
541121|NCT00186901|B1|Baseline|Placebo Group|Nutritional counseling + placebo
541122|NCT00186901|P3|Participant Flow|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
541123|NCT00186901|P2|Participant Flow|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
541124|NCT00186901|P1|Participant Flow|Placebo Group|Nutritional counseling + placebo
541125|NCT00186901|O3|Outcome|Bsm - bb Genotype|The bb genotype was observed in 77 (18.47%) out of 417 participants, with a median BMD Z score of -0.17.
541126|NCT00186901|O2|Outcome|Bsm - Bb Genotype|The Bb genotype was observed in 65 (15.59%) out of 417 participants, with a median BMD Z score of -0.17.
541127|NCT00186901|O1|Outcome|Bsm - BB Genotype|The BB genotype was observed in 41 (09.83%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.5.
541128|NCT00186901|O3|Outcome|Apa 1 - aa Genotype|The aa genotype was present in 49 (11.75%) out of 417 participants, with a median BMD Z score of -0.57.
541129|NCT00186901|O2|Outcome|Apa 1 - Aa Genotype|The Aa genotype was observed in 104 (24.94%) out of 417 participants, with a median BMD Z score of -0.44.
541130|NCT00186901|O1|Outcome|Apa 1 - AA Genotype|The AA genotype was observed in 68 (16.31%) out of 417 participants, with a median BMD Z score (a unit-less measure comparing to the age and gender matched national average) of -0.56.
541131|NCT00186901|O4|Outcome|Supplement - (DXA)|53 of the 96 patients assessed at 36 months also had a DXA scan.
541132|NCT00186901|O3|Outcome|Supplement - (QCT)|96 patients were assessed at 36 months using the QCT scan.
541133|NCT00186901|O2|Outcome|Placebo - (DXA)|36 of the 84 patients assessed at 36 months also had a DXA scan.
541134|NCT00186901|O1|Outcome|Placebo - (QCT)|84 patients were assessed at 36 months using the QCT scan.
541135|NCT00186901|O4|Outcome|Supplement - (DXA)|51 of the 97 patients assessed at 24 months also had a DXA scan.
541136|NCT00186901|O3|Outcome|Supplement - (QCT)|97 patients were assessed at 24 months using the QCT scan.
541137|NCT00186901|O2|Outcome|Placebo - (DXA)|39 of the 91 patients assessed at 24 months also had a DXA scan.
541138|NCT00186901|O1|Outcome|Placebo - (QCT)|91 patients were assessed at 24 months using the QCT scan.
541139|NCT00186901|O4|Outcome|Supplement - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
541140|NCT00186901|O3|Outcome|Supplement - (QCT)|109 patients were assessed at 12 months using the QCT scan.
541141|NCT00186901|O2|Outcome|Placebo - (DXA)|47 of the 109 patients assessed at 12 months also had a DXA scan.
541142|NCT00186901|O1|Outcome|Placebo - (QCT)|109 patients were assessed at 12 months using the QCT scan.
541143|NCT00186901|O4|Outcome|Supplement - (DXA)|61 of the 141 baseline patients also had a DXA scan.
541144|NCT00186901|O3|Outcome|Supplement - (QCT)|141 patients were assessed at baseline using the QCT scan.
541145|NCT00186901|O2|Outcome|Placebo - (DXA)|60 of the 134 baseline patients also had a DXA scan.
541146|NCT00186901|O1|Outcome|Placebo - (QCT)|134 patients were assessed at baseline using the QCT scan.
541147|NCT00186901|O4|Outcome|Above 22 Years|113 patients greater than 22 years of age were eligible for the study
541148|NCT00186901|O3|Outcome|18 to 22 Years|74 patients between the ages of 18 and 22 were eligible for the study
541149|NCT00186901|O2|Outcome|13 to 18 Years|139 patients between the ages of 13 and 18 were eligible for the study
541155|NCT00186901|O2|Outcome|Supplement|CVD Supplement Group (Experimental 1B): Patients who received calcium and vitamin D supplementation.
541156|NCT00186901|O1|Outcome|Placebo|Placebo Group (Placebo Comparator 1A): Patients who received placebo pills.
541157|NCT00186901|E3|Reported Event|Patients Ineligible for Randomization|424 patients were enrolled into the study, 149 were ineligible for randomization.
541158|NCT00186901|E2|Reported Event|Supplement Group|Nutritional counseling + supplementation with calcium, 1000mg/day + vitamin D, 800 units/day, for a 2 year period
541159|NCT00186901|E1|Reported Event|Placebo Group|Nutritional counseling + placebo
541160|NCT00186888|B4|Baseline|Total|Total of all reporting groups
541161|NCT00186888|B3|Baseline|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
541162|NCT00186888|B2|Baseline|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541163|NCT00186888|B1|Baseline|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
541164|NCT00186888|P3|Participant Flow|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
541165|NCT00186888|P2|Participant Flow|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541166|NCT00186888|P1|Participant Flow|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
541167|NCT00186888|O1|Outcome|5 Years|Participant age was 5 years ±3 months.
541168|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
541169|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
541170|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
541171|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
541172|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
541173|NCT00186888|O1|Outcome|Baseline|At study entry.
541174|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
541175|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
541176|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
541177|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
541178|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
541179|NCT00186888|O1|Outcome|Baseline|At study entry.
541180|NCT00186888|O2|Outcome|Occupational Therapy Did Not Recommend Rehabilitation Services|Occupational therapy evaluation did not recommend rehabilitation services.
541181|NCT00186888|O1|Outcome|Occupational Therapy Recommended Rehabilitation Services|Occupational therapy evaluation recommended rehabilitation services.
541182|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
541183|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
541184|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
541185|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
541186|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
541187|NCT00186888|O1|Outcome|Baseline|At study entry.
541188|NCT00186888|O6|Outcome|5 Years|Participant age was 5 years ±3 months.
541189|NCT00186888|O5|Outcome|3 Years|Participant age was 3 years ±3 months.
541190|NCT00186888|O4|Outcome|2 Years|Participant age was 2 years ±3 months.
541191|NCT00186888|O3|Outcome|1 Year|Participant age was 1 year ±3 months.
541192|NCT00186888|O2|Outcome|6 Months|Participants at 6 months of age ±3 months.
541193|NCT00186888|O1|Outcome|Baseline|At study entry.
541194|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541195|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541252|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541253|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541196|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541197|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541198|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541199|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541200|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541201|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (AJCC=1, 1a or 1b) and advanced (AJCC=2, 2a, 2b, 3, 3a, 3b) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541202|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541203|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541204|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC=A and B) and advanced (IC=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541205|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC group=A and B) and advanced (IC group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541206|NCT00186888|O4|Outcome|Stratum B-Advanced Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541254|NCT00186537|E3|Reported Event|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541255|NCT00186537|E2|Reported Event|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541207|NCT00186888|O3|Outcome|Stratum B-Early Disease|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541208|NCT00186888|O2|Outcome|Stratum A-Advanced Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541209|NCT00186888|O1|Outcome|Stratum A-Early Disease|"Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.~The patients were re-classified into 2 groups of early (IC Group=A and B) and advanced (IC Group=C, D, E) retinoblastoma. The analysis was done at eye level since each eye in the same patient could be a different group."
541210|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541211|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541212|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
541213|NCT00186888|O1|Outcome|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
541214|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541215|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541216|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541217|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541218|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541219|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541220|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541221|NCT00186888|O1|Outcome|Stratum B|"Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.~Two patients (3 eyes) in stratum B received external beam radiation therapy (EBRT), and the same 2 patients later required enucleation of the treated eye, thus the failure (event number) and censoring status were not changed for the 2 patients."
541222|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541223|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541224|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541225|NCT00186888|O1|Outcome|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541226|NCT00186888|E3|Reported Event|Stratum C|Advanced Unilateral Retinoblastoma. Research participants with unilateral (unifocal or multifocal) advanced (Reese-Ellsworth group IV or V) intraocular disease will undergo upfront enucleation. Adjuvant therapy was also indicated in certain cases.
541227|NCT00186888|E2|Reported Event|Stratum B|Advanced Bilateral Retinoblastoma. Stratum B includes patients with at least one Reese-Ellsworth group IV or V eye that after careful evaluation by the treating team is considered not to require upfront enucleation. A proportion of patients treated on this stratum will not have advanced disease in both eyes. Only stratum B patients received window therapy consisting of 2 courses of vincristine and topotecan.
541228|NCT00186888|E1|Reported Event|Stratum A|Early Unilateral or Bilateral Retinoblastoma. Stratum A includes mainly patients with early stage (Reese-Ellsworth group I, II, or III) bilateral retinoblastoma. Patients with unilateral disease diagnosed at an early stage, and patients with early multifocal unilateral disease are rare, but these patients are also candidates for conservative management and were treated in stratum A.
541229|NCT00186875|B3|Baseline|Total|Total of all reporting groups
541230|NCT00186875|B2|Baseline|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
541231|NCT00186875|B1|Baseline|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
541232|NCT00186875|P2|Participant Flow|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
541233|NCT00186875|P1|Participant Flow|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
541234|NCT00186875|O2|Outcome|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
541235|NCT00186875|O1|Outcome|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
541236|NCT00186875|E2|Reported Event|High Risk|Participants with T-cell ALL who develop a hematological [isolated bone marrow (BM) or combined] relapse, irrespective of length of initial remission, participants with B-lineage ALL who develop early hematological relapse (isolated BM or combined), and participants relapsing after hematopoietic stem cell transplantation.
541237|NCT00186875|E1|Reported Event|Standard Risk|Participants with isolated extramedullary relapse (with blasts in bone marrow (BM) <5%) regardless of the timing of relapse, and participants with B-lineage ALL who develop a late hematological relapse (isolated BM or combined).
541238|NCT00186537|B4|Baseline|Total|Total of all reporting groups
541239|NCT00186537|B3|Baseline|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541240|NCT00186537|B2|Baseline|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541241|NCT00186537|B1|Baseline|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541242|NCT00186537|P3|Participant Flow|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541243|NCT00186537|P2|Participant Flow|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541244|NCT00186537|P1|Participant Flow|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541245|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541246|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541247|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541248|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541249|NCT00186537|O2|Outcome|Rosiglitazone|"4 mg/daily 4 weeks followed by 4 mg 2 x daily for 8 weeks~Rosiglitazone"
541250|NCT00186537|O1|Outcome|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541251|NCT00186537|O3|Outcome|Calorie Restricted Diet|"calorie restricted to achieve 0.5 kg weight loss/week x 12 weeks~Weight Loss"
541256|NCT00186537|E1|Reported Event|Fenofibrate|"160 mg daily for 12 weeks~Fenofibrate"
541257|NCT00185965|B3|Baseline|Total|Total of all reporting groups
541258|NCT00185965|B2|Baseline|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541259|NCT00185965|B1|Baseline|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541260|NCT00185965|P2|Participant Flow|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541261|NCT00185965|P1|Participant Flow|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541262|NCT00185965|O2|Outcome|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541263|NCT00185965|O1|Outcome|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541264|NCT00185965|E2|Reported Event|Mycosis Fungoides (MF)|"Recurrent mycosis fungoides patients (at least one prior failure of topical or systemic treatment)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541265|NCT00185965|E1|Reported Event|Lymphoma, B-cell Low-grade (BCL)|"Recurrent low-grade B-cell lymphoma patients (at least one prior treatment failure)~CPG 7909: 6 mg intratumoral injection, administered immediately before 2 Gy radiotherapy (RT) to a designated tumor lesion, about 24 hours later after a 2nd 2 Gy RT dose, then weekly for 8 additional weeks (total of 10 injections)."
541266|NCT00185692|B1|Baseline|Transplating of CD34+ Selected Hematopietic Cells|
541267|NCT00185692|P1|Participant Flow|Transplating of CD34+ Selected Hematopietic Cells|
541268|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
541269|NCT00185692|O1|Outcome|Transplantation of CD34+ Cells|"Week #1: Total Lymphoid Inrradiation (TLI) 120 cGy + Anti-thymocyte Globulin (ATG) 1.5 mg/kg + Solumedrol 1.0 mg/kg Daily for 5 days.~Week #2: TLI 120 cGy (3 days a week, double on the 4th day) 5 days of CSP (oraly) one day after TLI was started. 3 days of MMF 4 days after TLI was started.~non-myeloablative hematopoietic cell transplantation: TLI and ATG infusion of the donor graft Post-transplant immunosuppression with cyclosporine and mycophenolate mofetil.~Anti-Thymocyte Globulin: 1.5 mg/kg QD x 5, IV. Dosage will be based on body weight.~Purified, sterile IgG fraction of immune serum of rabbits immumixied with human thymus lymphocyte. This drug acts to modify the number and function of lymphocytes.~Cyclosporine: 6.25 mg/kg BID, PO.Mechanism of action is inhibition of T-cell activation by binding to a cytoplasmic protein (cyclophillin).~Mycophenolate Mofetil: 15 mg/kg Q 8 hours, PO. Inhibtis the enzme inosine monophsophate dehydrogenase (MPDII) noncompetitively"
541270|NCT00185692|E1|Reported Event|Transplating of CD34+ Selected Hematopietic Cells|
541271|NCT00185679|B1|Baseline|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541272|NCT00185679|P1|Participant Flow|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541273|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541274|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541275|NCT00185679|O1|Outcome|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541276|NCT00185679|E1|Reported Event|Haploidentical Allogeneic Transplant Using CliniMACS System|"The CliniMACS cell selection system (Miltenyi Biotec) will be used to enrich hematopoietic stem cells from related, haploidentical, HLA-matched donors, who matched on the A,B,C and DRB1, DQ loci.~CliniMACS System: The CliniMACS System is a cell selection device consisting of the following components:~Computer-controlled instrument;~Sterile disposable tubing set (PVC tubing, filters and bags connected to two separation columns containing an iron/plastic matrix)~Anti-CD34 antibody reagent (murine monoclonal antibody chemically coupled to a magnetic particle)~Wash buffer"
541277|NCT00185588|B5|Baseline|Total|Total of all reporting groups
541278|NCT00185588|B4|Baseline|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541279|NCT00185588|B3|Baseline|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541280|NCT00185588|B2|Baseline|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541281|NCT00185588|B1|Baseline|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541282|NCT00185588|P4|Participant Flow|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541283|NCT00185588|P3|Participant Flow|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541284|NCT00185588|P2|Participant Flow|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541285|NCT00185588|P1|Participant Flow|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541286|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541287|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541288|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541289|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541290|NCT00185588|O4|Outcome|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541291|NCT00185588|O3|Outcome|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541292|NCT00185588|O2|Outcome|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541293|NCT00185588|O1|Outcome|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541294|NCT00185588|E4|Reported Event|Stage 2 Dose Expansion - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 500 mg twice daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541295|NCT00185588|E3|Reported Event|Stage 1 Dose Explrtion2 - Gemcitabine850+Vatalanib 2x250/2x500|"Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541296|NCT00185588|E2|Reported Event|Stage 1 Dose Exploration 1 - Gemcitabine 850 + Vatalanib 1250|"Gemcitabine 850 mg/m2 + vatalanib 1250 mg~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541297|NCT00185588|E1|Reported Event|Stage 1 Dose Exploration 0 - Gemcitabine 700 + Vatalanib 1250|"Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily~Vatalanib: Vatalanib 250 mg PO Q12 x 7 days, 8th day forward 500 mg PO Q12~Gemcitabine: 850 mg/m2"
541380|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541298|NCT00185458|B1|Baseline|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
541299|NCT00185458|P1|Participant Flow|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
541300|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541301|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541302|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541303|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541304|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541305|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541306|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541307|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541308|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541309|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541310|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541311|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541312|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541313|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541314|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541315|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541316|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541317|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541318|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541319|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541320|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541321|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541322|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541323|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541324|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541325|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541326|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541327|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541328|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541329|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541330|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541331|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541332|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541333|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541334|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541335|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541336|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541337|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541338|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541339|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541340|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541341|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541550|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541342|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
541343|NCT00185458|O3|Outcome|12 Months After Start of HRT Phase|Patient assessment about day 360 of the HRT phase
541344|NCT00185458|O2|Outcome|6 Months After Start of HRT Phase|Patient assessment about day 180 of the HRT phase
541345|NCT00185458|O1|Outcome|Last Measurement Before Start of HRT Phase|Patient assessment at the end of contraception phase
541346|NCT00185458|O1|Outcome|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
541347|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
541348|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
541349|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
541350|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
541351|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
541352|NCT00185458|O5|Outcome|Reference Period 4 (HRT Phase)|Patient assessment within day 271 to 360 of the HRT phase
541353|NCT00185458|O4|Outcome|Reference Period 3 (HRT Phase)|Patient assessment within day 181 to 270 of the HRT phase
541354|NCT00185458|O3|Outcome|Reference Period 2 (HRT Phase)|Patient assessment within day 91 to 180 of the HRT phase
541355|NCT00185458|O2|Outcome|Reference Period 1 (HRT Phase)|Patient assessment within the first 90-days of the HRT phase
541356|NCT00185458|O1|Outcome|Reference Period -1 (Contraception Phase)|Patient assessment within the last 90-days before starting the HRT
541357|NCT00185458|E1|Reported Event|LNG IUS|Levonorgestrel Intrauterine System (LNG IUS) (initial in vitro release 20 µg/24h) intrauterine for minimum of 9 months and maximum of 60 months - 2 phases: a) Contraception Phase b) Hormone-Replacement Therapy (HRT) Phase. For outcome measures (vaginal bleeding variables), five 90-day Reference Periods were defined, which were used for comparison during statistical analysis: Reference Period -1 in Contraception Phase; Reference Periods 1-4 in HRT Phase. 90-day reference periods for analyzing vaginal bleeding data are defined by World Health Organization (WHO) guideline. Reference Period -1 is the last 90-day reference period that the subject had before starting the HRT. Reference Period 1 covers the first 90-days of the HRT phase, Reference Period 2 covers days 91 to 180, Reference Period 3 days 181 to 270, and Reference Period 4 days 271 to 360 of the HRT phase.
541358|NCT00185380|B4|Baseline|Total|Total of all reporting groups
541359|NCT00185380|B3|Baseline|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541360|NCT00185380|B2|Baseline|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541361|NCT00185380|B1|Baseline|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541362|NCT00185380|P3|Participant Flow|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541363|NCT00185380|P2|Participant Flow|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541364|NCT00185380|P1|Participant Flow|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541365|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541366|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541367|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541368|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541369|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541370|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541371|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541372|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541373|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541374|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541375|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541376|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541377|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541378|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541379|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541381|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541382|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541383|NCT00185380|O3|Outcome|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541384|NCT00185380|O2|Outcome|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541385|NCT00185380|O1|Outcome|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541386|NCT00185380|E3|Reported Event|IUS20 (Mirena)|Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
541387|NCT00185380|E2|Reported Event|LCS16|Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro
541388|NCT00185380|E1|Reported Event|LCS12|Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro
541389|NCT00185211|B3|Baseline|Total|Total of all reporting groups
541390|NCT00185211|B2|Baseline|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541391|NCT00185211|B1|Baseline|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541392|NCT00185211|P2|Participant Flow|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541393|NCT00185211|P1|Participant Flow|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541394|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541395|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541396|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541397|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541398|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541399|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541400|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541401|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541402|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541403|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541404|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541405|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541406|NCT00185211|O1|Outcome|All Subjects|All subjects part of Intention-To-Treat (ITT) Population
541407|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541408|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541409|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541410|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541411|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541412|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541413|NCT00185211|O2|Outcome|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541414|NCT00185211|O1|Outcome|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541415|NCT00185211|E2|Reported Event|Initial Placebo|Initial placebo treatment; Betaferon/Betaseron, 250 ug administered s.c. (subcutaneous) every other day offered in Follow-up phase (= this trial)
541416|NCT00185211|E1|Reported Event|Initial IFNB-1b (Interferon Beta-1b)|Initial Betaferon/Betaseron treatment (Interferon beta-1b, IFNB-1b), 250 ug administered s.c. (subcutaneous) every other day, continued in Follow-up phase
541417|NCT00184717|B4|Baseline|Total|Total of all reporting groups
541418|NCT00184717|B3|Baseline|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
541419|NCT00184717|B2|Baseline|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541420|NCT00184717|B1|Baseline|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541421|NCT00184717|P5|Participant Flow|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541422|NCT00184717|P4|Participant Flow|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541423|NCT00184717|P3|Participant Flow|No Treatment|No somatropin (NN-220) treatment was given in the 52-week main period. Subjects was re-randomised to recive two dosing regimens (0.033 mg/kg/day or 0.067 mg/kg/day) in the 208-week extension period
541424|NCT00184717|P2|Participant Flow|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541425|NCT00184717|P1|Participant Flow|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541426|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541427|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541428|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541429|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541430|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541431|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541432|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541433|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541434|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541435|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541436|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541437|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541438|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541439|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541440|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541441|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541442|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541443|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541444|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541445|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541446|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541447|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541448|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541449|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541450|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541451|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541452|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541453|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541454|NCT00184717|O4|Outcome|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541455|NCT00184717|O3|Outcome|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541456|NCT00184717|O2|Outcome|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541457|NCT00184717|O1|Outcome|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541458|NCT00184717|E4|Reported Event|No Treatment --> 0.067 mg|In the 208-week extension period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541459|NCT00184717|E3|Reported Event|No Treatment --> 0.033 mg|In the 208-week extension period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime after having received no somatromin (NN-220) treatment in the 52-week main period
541460|NCT00184717|E2|Reported Event|0.067 mg / NN-220|In the 156-week main period, subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.067 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541461|NCT00184717|E1|Reported Event|0.033 mg / NN-220|In the 156-week main period, subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime followed by a 104-week extension period where subjects received 0.033 mg/kg/day somatropin (NN-220) s.c. (under the skin) injected at bedtime
541462|NCT00184600|B4|Baseline|Total|Total of all reporting groups
541463|NCT00184600|B3|Baseline|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541464|NCT00184600|B2|Baseline|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541551|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541552|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541553|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541465|NCT00184600|B1|Baseline|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541466|NCT00184600|P3|Participant Flow|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541467|NCT00184600|P2|Participant Flow|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541468|NCT00184600|P1|Participant Flow|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541469|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541470|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541471|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541472|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541560|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
541605|NCT00183677|O1|Outcome|Open Label Escitalopram|Participants received open treatment with escitalopram.
541473|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541474|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541475|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541476|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541477|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541478|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541479|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541480|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541554|NCT00184548|E4|Reported Event|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541481|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541482|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541483|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541484|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541485|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541486|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541487|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541488|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541555|NCT00184548|E3|Reported Event|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
542115|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
541489|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541490|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541491|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541492|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541493|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541494|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541495|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541496|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541556|NCT00184548|E2|Reported Event|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541497|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541498|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541499|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541500|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541501|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541502|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541503|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541504|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541557|NCT00184548|E1|Reported Event|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541505|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541506|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541507|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541508|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541509|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541510|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541511|NCT00184600|O3|Outcome|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541512|NCT00184600|O2|Outcome|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541558|NCT00184054|B1|Baseline|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
541559|NCT00184054|P1|Participant Flow|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
541513|NCT00184600|O1|Outcome|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541514|NCT00184600|E3|Reported Event|Biphasic Insulin Aspart 30 (Biphasic Insulin)|Individually adjusted biphasic insulin aspart 30 injected subcutaneously twice daily with meals (breakfast and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to biphasic insulin aspart twice daily were asked to add insulin aspart at lunchtime (midday) i.e. an augmented pre-mixed insulin analogue regimen
541515|NCT00184600|E2|Reported Event|Insulin Aspart (Prandial Insulin)|Individually adjusted insulin aspart injected subcutaneously at meal-times (breakfast, lunch and dinner) and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin aspart three times a day with meals were asked to add insulin detemir once or twice daily i.e. a basal-bolus insulin analogue regimen
541516|NCT00184600|E1|Reported Event|Insulin Detemir (Basal Insulin)|Individually adjusted insulin detemir injected subcutaneously once daily before bed and administered in combination with current OAD treatment. At week 24 and thereafter, if two consecutive measurements of HbA1c were at least 8%, or one measurement of HbA1c was at least 10% the subject was deemed to have unacceptable hyperglycaemia and a second insulin formulation was added. Subjects had the option to add a second pre-breakfast basal insulin analogue injection if pre-breakfast but not pre-dinner meal plasma glucose targets were met. In the second and third years, a third insulin formulation was added if subjects failed to achieve or to maintain good glycaemic control, defined as two consecutive HbA1c measurements exceeding 6.5% or a single measurement exceeding 7.5%. Subjects randomised to insulin detemir once (or twice) daily were asked to add insulin aspart three times daily with meals i.e. a basal-bolus insulin analogue regimen
541517|NCT00184548|B5|Baseline|Total|Total of all reporting groups
541518|NCT00184548|B4|Baseline|Placebo, Penetrating Trauma|
541519|NCT00184548|B3|Baseline|rFVIIa, Penetrating Trauma|
541520|NCT00184548|B2|Baseline|Placebo, Blunt Trauma|
541521|NCT00184548|B1|Baseline|rFVIIa, Blunt Trauma|
541522|NCT00184548|P4|Participant Flow|Placebo, Penetrating Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541523|NCT00184548|P3|Participant Flow|rVIIa, Penetrating Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541524|NCT00184548|P2|Participant Flow|Placebo, Blunt Trauma|Three single doses of placebo (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541525|NCT00184548|P1|Participant Flow|rFVIIa, Blunt Trauma|Three single doses of activated recombinant human factor VII (rFVIIa) (200 mcg/kg, 100 mcg/kg, and 100 mcg/kg) administered over approximately three hours. First dose was administered within a maximum of 12 hours from injury. A second dose was to be administered one hour after the initial dose, and a third dose was to be administered three hours after the initial dose.
541526|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541527|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541528|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541529|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541530|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541531|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541532|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541533|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541534|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541535|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541536|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541537|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541538|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541539|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541540|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541541|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541542|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541543|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541544|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541545|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541546|NCT00184548|O4|Outcome|Placebo, Penetrating Trauma|
541547|NCT00184548|O3|Outcome|rFVIIa, Penetrating Trauma|
541548|NCT00184548|O2|Outcome|Placebo, Blunt Trauma|
541549|NCT00184548|O1|Outcome|rFVIIa, Blunt Trauma|
541561|NCT00184054|O1|Outcome|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
541562|NCT00184054|E1|Reported Event|Arsenic Trioxide (ATO) Plus Ascorbic Acid|All subjects received ATO 0.25 mg/kg/day intravenously for 25 days over a 35-day period and Ascorbic Acid 1000 mg/day intravenously every other day that ATO is given
541563|NCT00184028|B1|Baseline|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
541564|NCT00184028|P1|Participant Flow|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
541565|NCT00184028|O1|Outcome|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
541566|NCT00184028|O1|Outcome|Arm 1|Single arm study
541567|NCT00184028|E1|Reported Event|Taxotere Followed by Oxaliplatin|On Day 1 of each day treatment cycle, patients receive Taxotere 60 mg/m2 as a 1-hour IV infusion, followed by the administration of oxaliplatin 100 mg/m2. Oxaliplatin will be administered IV over 2 hours at a rate of 10mg/m2/min. This treatment regimen will be repeated every 21 days.
541568|NCT00183963|B5|Baseline|Total|Total of all reporting groups
541569|NCT00183963|B4|Baseline|Arm 4: High Dose Fulvestrant|
541570|NCT00183963|B3|Baseline|Arm 3: Low Dose Fulvestrant|
541571|NCT00183963|B2|Baseline|Arm 2: Tamoxifen Group|
541572|NCT00183963|B1|Baseline|Arm 1: Control Group|
541573|NCT00183963|P4|Participant Flow|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
541574|NCT00183963|P3|Participant Flow|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
541575|NCT00183963|P2|Participant Flow|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
541576|NCT00183963|P1|Participant Flow|Arm 1: Control Group|Placebo
541577|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
541578|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
541579|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
541580|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
541581|NCT00183963|O4|Outcome|Arm 4: High Dose Fulvestrant|500 mg given on day 1, administered by IM Injection
541582|NCT00183963|O3|Outcome|Arm 3: Low Dose Fulvestrant|250 mg given on day 1, administered by IM Injection
541583|NCT00183963|O2|Outcome|Arm 2: Tamoxifen Group|20 mg given by mouth daily for 21 days
541584|NCT00183963|O1|Outcome|Arm 1: Control Group|Placebo
541585|NCT00183963|E4|Reported Event|Arm 4: High Dose Fulvestrant|"Fulvestrant 500mg~Fulvestrant : 500mg given on day 1, administered by IM Injection"
541586|NCT00183963|E3|Reported Event|Arm 3: Low Dose Fulvestrant|"Fulvestrant 250mg~Fulvestrant : 250mg given on day 1, administered by IM Injection"
541587|NCT00183963|E2|Reported Event|Arm 2: Tamoxifen Group|"Tamoxifen 20 mg~Tamoxifen : 20mg daily, by mouth x 21 days"
541588|NCT00183963|E1|Reported Event|Arm 1: Control Group|Placebo
541589|NCT00183794|B1|Baseline|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
541590|NCT00183794|P1|Participant Flow|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
541591|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
541592|NCT00183794|O1|Outcome|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
541593|NCT00183794|E1|Reported Event|Gemcitabine and Docetaxel|Patients will receive Docetaxel 75mg/m2 IV over 15-30 minutes on day 1 followed by Gemcitabine 800 mg/m2 IV over 30 minutes on Days 1 and 8. Cycles will be repeated every 3 weeks.
541594|NCT00183729|B3|Baseline|Total|Total of all reporting groups
541595|NCT00183729|B2|Baseline|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
541596|NCT00183729|B1|Baseline|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
541597|NCT00183729|P2|Participant Flow|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
541598|NCT00183729|P1|Participant Flow|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
541599|NCT00183729|O2|Outcome|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
541600|NCT00183729|O1|Outcome|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
541601|NCT00183729|E2|Reported Event|Placebo (2)|"Placebo for 12 weeks~Placebo: Placebo distribution is planned to mimic the active drug."
541602|NCT00183729|E1|Reported Event|Memantine (1)|"Memantine for 12 weeks~Memantine: Memantine dosage is started at 10 mg daily and is increased at Week 1 as tolerated to 10 mg two times a day."
541603|NCT00183677|B1|Baseline|Open Label Escitalopram|Participants will receive treatment with escitalopram.
541604|NCT00183677|P1|Participant Flow|Open Label Escitalopram|Participants will receive treatment with escitalopram.
541606|NCT00183677|E1|Reported Event|Open Label Escitalopram|Participants will receive treatment with escitalopram.
541607|NCT00183625|B3|Baseline|Total|Total of all reporting groups
541608|NCT00183625|B2|Baseline|Olanzapine Treatment|
541609|NCT00183625|B1|Baseline|Risperidone Treatment|
541610|NCT00183625|P4|Participant Flow|Olanzapine + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
541611|NCT00183625|P3|Participant Flow|Risperidone + Supported Employment + Skills|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
541612|NCT00183625|P2|Participant Flow|Olanzapine Plus Supported Employment|Individual Placement and Support plus Olanzapine. Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
541613|NCT00183625|P1|Participant Flow|Risperidone Plus Supported Employment|Participants were randomized at baseline to risperidone or olanzapine and Individual Placement and Support with or without workplace fundamentals. The WIPS was not implemented until participant obtained a job.
541614|NCT00183625|O2|Outcome|Olanzapine Treatment|
541615|NCT00183625|O1|Outcome|Risperidone Treatment|
541616|NCT00183625|O2|Outcome|Individual Placement and Support With Workplace Fundamentals|Olanzapine and Risperidone Patients included.
541617|NCT00183625|O1|Outcome|Individual Placement and Support (IPS)|IPS alone for risperidone and olanzapine subjects
541618|NCT00183625|E2|Reported Event|Olanzapine Treatment|
541619|NCT00183625|E1|Reported Event|Risperidone Treatment|
541620|NCT00183469|B3|Baseline|Total|Total of all reporting groups
541621|NCT00183469|B2|Baseline|Lamotrigine Plus Placebo Divalproex ER|
541622|NCT00183469|B1|Baseline|Lamotrigine Plus Divalproex ER|Enrolled subjects received lamotrigine and divalproex ER
541623|NCT00183469|P2|Participant Flow|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
541624|NCT00183469|P1|Participant Flow|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
541625|NCT00183469|O2|Outcome|Double-Blind Lamotrigine and Placebo Divalproex ER|Double-Blind randomized Participants will take active lamotrigine and placebo divalproex ER
541626|NCT00183469|O1|Outcome|Double-Blind Lamotrigine and Divalproex ER|Double blind randomized participants will take active lamotrigine and active divalproex Er
541627|NCT00183469|E2|Reported Event|Lamotrigine Plus Placebo Divalproex ER|randomized subjects will take active lamotrigine and placebo divalproex ER
541628|NCT00183469|E1|Reported Event|Lamotrigine Plus Active Divalproex ER|randomized participants will take active lamotrigine and active divalproex Er
541629|NCT00183456|B5|Baseline|Total|Total of all reporting groups
541630|NCT00183456|B4|Baseline|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541631|NCT00183456|B3|Baseline|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541632|NCT00183456|B2|Baseline|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541633|NCT00183456|B1|Baseline|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541634|NCT00183456|P4|Participant Flow|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541635|NCT00183456|P3|Participant Flow|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541636|NCT00183456|P2|Participant Flow|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541637|NCT00183456|P1|Participant Flow|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541638|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541639|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541640|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541641|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541642|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541643|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541644|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541645|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541646|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541647|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541648|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541649|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541650|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541651|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541652|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541653|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541654|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541655|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541656|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541657|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541658|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541659|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541660|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541661|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541662|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541663|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541664|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541665|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541666|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541667|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541668|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541669|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541670|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541671|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541672|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541673|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541674|NCT00183456|O4|Outcome|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541675|NCT00183456|O3|Outcome|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541676|NCT00183456|O2|Outcome|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541677|NCT00183456|O1|Outcome|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541678|NCT00183456|E4|Reported Event|Non-randomized Baseline Index Participants|This arm includes those index participants that did not show up for randomization or did not recruit a network member were thus not eligible to be randomized into a study condition.
541679|NCT00183456|E3|Reported Event|Network Participants|Index participants generated a list of network members during their baseline visits and were asked to recruit eligible network members into the study. These network participants completed study interviews but did not participate in the intervention.
541680|NCT00183456|E2|Reported Event|Comparison Condition: Standard of Care|The comparison condition consisted of one group session. The session focused on HIV and STIs transmission and risk reduction information.
541681|NCT00183456|E1|Reported Event|Intervention Condition: CHAT|Participants received the program over the course of five small group sessions and one individual session based on a harm reduction philosophy. Participants were trained as Peer Mentors and were encouraged to talk to their family, friends, and sex partners about a range of sex risk reduction options.
541682|NCT00183430|B3|Baseline|Total|Total of all reporting groups
541683|NCT00183430|B2|Baseline|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541684|NCT00183430|B1|Baseline|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541685|NCT00183430|P2|Participant Flow|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541686|NCT00183430|P1|Participant Flow|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541687|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541688|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541689|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541690|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541691|NCT00183430|O2|Outcome|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541692|NCT00183430|O1|Outcome|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541693|NCT00183430|E2|Reported Event|Placebo|"Participants will receive treatment with placebo plus psychotherapy~Placebo : Placebo capsules are taken orally twice per day at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541830|NCT00182091|B3|Baseline|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
541694|NCT00183430|E1|Reported Event|Prazosin|"Participants will receive treatment with prazosin plus psychotherapy~Prazosin : Prazosin capsules 1 to 25 mg are taken orally twice per day in divided doses at 10 am and bedtime.~Psychotherapy : All participants will undergo psychotherapy during medication treatment period."
541695|NCT00183339|B3|Baseline|Total|Total of all reporting groups
541696|NCT00183339|B2|Baseline|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
541697|NCT00183339|B1|Baseline|Placebo|Participants will take the placebo
541698|NCT00183339|P2|Participant Flow|Fluoxetine|Participants who received liquid fluoxetine 2-20 mg (of 4mg/1ml solution) in AM using a flexible dose strategy and planned 36 week titration schedule
541699|NCT00183339|P1|Participant Flow|Placebo|Participants who received placebo solution between .5ml and 5.0ml
541700|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
541701|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
541702|NCT00183339|O2|Outcome|Fluoxetine|participants who were treated with flexible dose (2-20mg/D) fluoxetine solution
541703|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
541704|NCT00183339|O2|Outcome|Fluoxetine|Participants treated with flexible dose fluoxetine solution
541705|NCT00183339|O1|Outcome|Placebo|participants who were treated with flexible dose placebo solution
541706|NCT00183339|O2|Outcome|Fluoxetine|Participants will take liquid fluoxetine 2-20 mg
541707|NCT00183339|O1|Outcome|Placebo|Participants will take the placebo
541708|NCT00183339|E2|Reported Event|Fluoxetine|participants who were treated with flexible dose fluoxetine solution, 2-20mg per day
541709|NCT00183339|E1|Reported Event|Placebo|participants who were treated with flexible dose placebo solution
541710|NCT00183274|B1|Baseline|Venlafaxine XR|"Venlafaxine XR flexible dose of 75 - 225 mg/d~Venlafaxine XR : All participants will take venlafaxine for 6 months. After this initial 6 months, participants who are not randomized to placebo will continue to take venlafaxine."
541711|NCT00183274|P6|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Placebo)|Patients administered placebo in Phase 2 continued to take placebo during Phase 3
541712|NCT00183274|P5|Participant Flow|Phase 3: Double-Blind Relapse Phase (Placebo After Drug)|Patients administered venlafaxine XR in Phase 2 were given a placebo in Phase 3
541713|NCT00183274|P4|Participant Flow|Phase 3: Double-Blind Relapse Phase (Drug After Drug)|Patients administered venlafaxine XR in phase 2 continued to take the drug during phase 3
541714|NCT00183274|P3|Participant Flow|Phase 2: Double-Blind Placebo|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in a 60:40 ratio of drug to placebo
541715|NCT00183274|P2|Participant Flow|Phase 2: Double-Blind Venlafaxine XR|Responders to 6 months of open-label venlafaxine XR treatment were randomized to double-blind treatment in 60:40 ratio of drug to placebo
541716|NCT00183274|P1|Participant Flow|Phase 1: Open-Label|Patients received 75mg - 225 mg of open-label venlafaxine XR for 6 months.
541717|NCT00183274|O6|Outcome|Placebo After Placebo|after receiving drug in phases 1 and placebo in phase 2, patients received placebo in phase 3
541718|NCT00183274|O5|Outcome|Phase 3: Placebo After Drug|after receiving drug in phases 1 and 2, patients received placebo in phase 3
541719|NCT00183274|O4|Outcome|Phase 3: Double-Blind Drug After Drug|after receiving drug in phases 1 and 2, patients continued to receive drug in phase 3
541720|NCT00183274|O3|Outcome|Phase 2: Double-Blind Placebo|After receiving drug in Phase 1, patients began receiving placebo in phase 2
541721|NCT00183274|O2|Outcome|Phase 2: Double-Blind Venlafaxine XR|after receiving drug in phase 1, patients continued to receive drug in phase 2
541722|NCT00183274|O1|Outcome|Phase 1: Open-Label Venlafaxine XR|A 6-month administration of Venlafaxine XR that occurred between months 1 - 6 of study.
541723|NCT00183274|O6|Outcome|Double-Blind Placebo After Placebo|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
541724|NCT00183274|O5|Outcome|Double-Blind Relapse Placebo After Drug|A 6-month double-blind administration of placebo that occurred between months 13 - 18.
541725|NCT00183274|O4|Outcome|Double-Blind Relapse Drug After Drug|A 6-month double-blind administration of Venlafaxine XR that occurred between months 13 - 18.
541726|NCT00183274|O3|Outcome|Double-Blind Placebo|A 6-month double-blind administration of placebo that occurred between months 7 - 12.
541727|NCT00183274|O2|Outcome|Double-Blind Venlafaxine XR|A 6-month double-blind administration of Venlafaxine XR that occurred between months 7 - 12.
541728|NCT00183274|O1|Outcome|Open-Label: Venlafaxine XR|A 6-month open label administration of flexible dose Venlafaxine XR that occurred between months 1 - 6 of study.
541729|NCT00183274|E1|Reported Event|Venlafaxine XR|Adverse events were expected with venlafaxine XR. AEs were reported at least once by at least 5% of the study population for all patients who entered treatment. None of the adverse events that were expected or that occurred were considered serious or life threatening.
541730|NCT00183248|B3|Baseline|Total|Total of all reporting groups
541731|NCT00183248|B2|Baseline|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541732|NCT00183248|B1|Baseline|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541733|NCT00183248|P2|Participant Flow|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541831|NCT00182091|B2|Baseline|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541734|NCT00183248|P1|Participant Flow|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541735|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541736|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541737|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541738|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541739|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541740|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541741|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541742|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541743|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541744|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541745|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541746|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541747|NCT00183248|O2|Outcome|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541748|NCT00183248|O1|Outcome|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included Alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled 'Detailed Description' for additional treatment information.
541749|NCT00183248|E2|Reported Event|Control Group|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive induction therapy with alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541794|NCT00182767|P2|Participant Flow|Ixabepilone: 32mg/m2 and Doxil 30 mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
543752|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
541750|NCT00183248|E1|Reported Event|DBMCs|Recipients of 1-haplotype human leukocyte antigen (HLA) matched living-donor related kidney transplantation were randomized to receive (CD34+ stem cell purified) Donor-specific Bone Marrow Cells (DBMCs). Induction therapy included alemtuzumab and steroid-free dose maintenance immunosuppression consisting of mycophenolate mofetil, tacrolimus and sirolimus. Refer to section titled ‘Detailed Description’ for additional treatment information.
541751|NCT00183196|B4|Baseline|Total|Total of all reporting groups
541752|NCT00183196|B3|Baseline|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
541753|NCT00183196|B2|Baseline|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
541754|NCT00183196|B1|Baseline|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
541755|NCT00183196|P3|Participant Flow|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
541756|NCT00183196|P2|Participant Flow|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
541757|NCT00183196|P1|Participant Flow|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
541758|NCT00183196|O3|Outcome|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
541759|NCT00183196|O2|Outcome|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
541760|NCT00183196|O1|Outcome|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
541761|NCT00183196|E3|Reported Event|Placebo Plus Placebo Plus CBI|Placebo plus placebo for 6 weeks and CBI individual counseling then placebo and CBI counseling for 10 additional weeks.
541762|NCT00183196|E2|Reported Event|Naltrexone Plus Placebo and CBI|Naltrexone plus placebo and CBI individual counseling for 6 weeks then naltrexone and CBI counseling for 10 weeks.
541763|NCT00183196|E1|Reported Event|Naltrexone Plus Gabapentin and CBI|Naltrexone plus gabapentin and CBI individual counseling for 6 weeks then naltrexone and CBI for 10 additional weeks.
541764|NCT00183092|B3|Baseline|Total|Total of all reporting groups
541765|NCT00183092|B2|Baseline|Quinacrine|Quinacrine : 100mg by mouth three times a day
541766|NCT00183092|B1|Baseline|Placebo|Placebo : 100mg by mouth three times a day
541767|NCT00183092|P4|Participant Flow|Study Drug (Placebo) During Open-Label Period|Participants received Placebo during Double-Blind period and opted to continue study drug during Open-Label period
541768|NCT00183092|P3|Participant Flow|Study Drug (Quinacrine) During Open-Label Period|Participants received Quinacrine during Double-Blind period and opted to continue study drug during Open-Label period
541769|NCT00183092|P2|Participant Flow|Placebo|Double Blind Period: 100mg Placebo by mouth three times a day. Open Label Period: Choice of study drug or Quinacrine 100mg by mouth three times a day.
541770|NCT00183092|P1|Participant Flow|Quinacrine|Double Blind Period: 100mg Quinacrine by mouth three times a day. Open Label Period: Choice of study drug or open-label Quinacrine 100mg by mouth three times a day.
541771|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541772|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541773|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541774|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541775|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541776|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541777|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541778|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541779|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541780|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541781|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541782|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541783|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541784|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541785|NCT00183092|O2|Outcome|Quinacrine|Quinacrine : 100mg by mouth three times a day
541786|NCT00183092|O1|Outcome|Placebo|Placebo : 100mg by mouth three times a day
541787|NCT00183092|E3|Reported Event|Quinacrine Open-label|Quinacrine: Month 2 until death = optional open-label Quinacrine 100mg by mouth three times a day
541788|NCT00183092|E2|Reported Event|Quinacrine Random Assignment|Quinacrine: 100mg by mouth three times a day. Baseline-Month 2 = random assignment (n=23), Month 2+ = optional continuation of assigned drug (n=1).
541789|NCT00183092|E1|Reported Event|Placebo Random Assignment|Placebo : 100mg by mouth three times a day, Baseline-Month 2 = random assignment (n=28), Month 2+ = optional continuation of assigned drug (n=1).
541790|NCT00182767|B1|Baseline|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541791|NCT00182767|P5|Participant Flow|Ixabepilone: 16mg/m2 and Doxil 30 mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541792|NCT00182767|P4|Participant Flow|Ixabepilone: 13mg/m2 and Doxil 30 mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541793|NCT00182767|P3|Participant Flow|Ixabepilone: 40mg/m2 and Doxil 30 mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541795|NCT00182767|P1|Participant Flow|Ixabepilone: 24mg/m2 and Doxil 30 mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541796|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541797|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541798|NCT00182767|O1|Outcome|Treatment (Ixabepilone and Doxorubicin)|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541799|NCT00182767|O5|Outcome|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541800|NCT00182767|O4|Outcome|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 28 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541801|NCT00182767|O3|Outcome|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541802|NCT00182767|O2|Outcome|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541803|NCT00182767|O1|Outcome|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1 every 21 days~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541804|NCT00182767|E5|Reported Event|Ixabepilone 16mg/m2 and Doxorubicin 30mg/m2: Level 5|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541805|NCT00182767|E4|Reported Event|Ixabepilone 13mg/m2 and Doxorubicin 30mg/m2: Level 4|"Ixabepilone IV over 3 hours on days 1, 8 and 15 and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541806|NCT00182767|E3|Reported Event|Ixabepilone 40mg/m2 and Doxorubicin 30mg/m2: Level 3|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541807|NCT00182767|E2|Reported Event|Ixabepilone 32mg/m2 and Doxorubicin 30mg/m2: Level 2|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541808|NCT00182767|E1|Reported Event|Ixabepilone 24mg/m2 and Doxorubicin 30mg/m2: Level 1|"Ixabepilone IV over 3 hours and pegylated liposomal doxorubicin hydrochloride IV over 30-60 minutes on day 1.~ixabepilone: Given IV~pegylated liposomal doxorubicin hydrochloride: Given IV"
541809|NCT00182689|B3|Baseline|Total|Total of all reporting groups
541810|NCT00182689|B2|Baseline|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
541811|NCT00182689|B1|Baseline|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
541812|NCT00182689|P2|Participant Flow|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
541813|NCT00182689|P1|Participant Flow|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
541814|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
541815|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment. All eligible patients who received treatment were included in baseline measures.
541816|NCT00182689|O2|Outcome|Platinum-Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
541817|NCT00182689|O1|Outcome|Platinum-Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
541818|NCT00182689|O2|Outcome|Platinum Refractory|Platinum-refractory disease defined as no response to platinum-based chemotherapy or progression during or <=90 days after the last platinum treatment.
541819|NCT00182689|O1|Outcome|Platinum Sensitive|Platinum-sensitive disease defined as an initial response to platinum-based chemotherapy and progression >90 days after the last platinum treatment.
541820|NCT00182689|E2|Reported Event|Platinum Refractory|
541821|NCT00182689|E1|Reported Event|Platinum Sensitive|
541822|NCT00182637|B1|Baseline|Bortezomib|administration of bortezomib
541823|NCT00182637|P1|Participant Flow|Bortezomib|administration of bortezomib
541824|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
541825|NCT00182637|O1|Outcome|Bortezomib|administration of bortezomib
541826|NCT00182637|O1|Outcome|Bortezomib|bortezomib
541827|NCT00182637|E1|Reported Event|Bortezomib|administration of bortezomib
541828|NCT00182091|B5|Baseline|Total|Total of all reporting groups
541829|NCT00182091|B4|Baseline|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
541832|NCT00182091|B1|Baseline|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541833|NCT00182091|P4|Participant Flow|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
541834|NCT00182091|P3|Participant Flow|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
541835|NCT00182091|P2|Participant Flow|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541836|NCT00182091|P1|Participant Flow|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541837|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541838|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541839|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541840|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541841|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541842|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541843|NCT00182091|O2|Outcome|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541844|NCT00182091|O1|Outcome|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541845|NCT00182091|E4|Reported Event|Active Acromegaly|Subjects with active acromegaly. This is not an interventional arm.
541846|NCT00182091|E3|Reported Event|AcroGHS|Subjects with a history of acromegaly who now have normal growth hormone levels. This is not an interventional arm.
541847|NCT00182091|E2|Reported Event|AcroGHD Randomized to Placebo|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to placebo. This is an interventional arm.
541848|NCT00182091|E1|Reported Event|AcroGHD Randomized to Growth Hormone|Subjects with a history of acromegaly who are now growth hormone deficient, randomized to growth hormone. This is an interventional arm.
541849|NCT00182078|B3|Baseline|Total|Total of all reporting groups
541850|NCT00182078|B2|Baseline|Sertraline|Sertraline group received study medication every day for 12 weeks.
541851|NCT00182078|B1|Baseline|Placebo|Placebo group who received no study medication.
541852|NCT00182078|P2|Participant Flow|Sertraline - Received Study Medication|The drugs were administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the medication was tapered at a rate of 25mg every 3 days until it was discontinued.
541853|NCT00182078|P1|Participant Flow|Placebo - Received Placebo|The placebo was administered for 24 weeks on a flexible fixed schedule beginning at 25mg per day, and increasing as high as 150 mg/day. Both groups received the assigned medication and dose over a 24-week period. At Week 12, the placebo was tapered at a rate of 25mg every 3 days until it was discontinued.
541854|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
541855|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
541856|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
541857|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
541858|NCT00182078|O2|Outcome|Sertraline|Sertraline group received study medication every day for 12 weeks.
541859|NCT00182078|O1|Outcome|Placebo|Placebo group who received no study medication.
541860|NCT00182078|E2|Reported Event|Sertraline|Sertraline group received study medication every day for 12 weeks.
541861|NCT00182078|E1|Reported Event|Placebo|Placebo group who received no study medication.
541862|NCT00182000|B3|Baseline|Total|Total of all reporting groups
541863|NCT00182000|B2|Baseline|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
541864|NCT00182000|B1|Baseline|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
541865|NCT00182000|P2|Participant Flow|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
541866|NCT00182000|P1|Participant Flow|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
541867|NCT00182000|O2|Outcome|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
541868|NCT00182000|O1|Outcome|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
541869|NCT00182000|E2|Reported Event|Placebo|10 twice-weekly sessions of behavior therapy plus 100mg tablet of placebo
541870|NCT00182000|E1|Reported Event|Seromycin|10 twice-weekly sessions of behavior therapy plus 100mg tablet of seromycin
541871|NCT00181883|B1|Baseline|Quetiapine|
541872|NCT00181883|P1|Participant Flow|Quetiapine|
541873|NCT00181883|O1|Outcome|Quetiapine|
541874|NCT00181883|E1|Reported Event|Quetiapine|
541875|NCT00181844|B1|Baseline|Lamotrigine|
541876|NCT00181844|P1|Participant Flow|Lamotrigine|
541877|NCT00181844|O1|Outcome|Lamotrigine|
541878|NCT00181844|E1|Reported Event|Lamotrigine|
541879|NCT00181766|B1|Baseline|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
541880|NCT00181766|P1|Participant Flow|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
541881|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
541882|NCT00181766|O1|Outcome|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
541883|NCT00181766|E1|Reported Event|Strattera (Atomoxetine)|Atomoxetine monotherapy up o 1.2 mg/kg/day or 120 mg/day.
541884|NCT00181714|B1|Baseline|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
541885|NCT00181714|P1|Participant Flow|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
541886|NCT00181714|O1|Outcome|OROS-Methylphenidate|
541887|NCT00181714|E1|Reported Event|OROS-Methylphenidate|Youth ages 12-17 years with DSM-IV ADHD, treated with open-label OROS-MPH.
541888|NCT00181623|B1|Baseline|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
541889|NCT00181623|P1|Participant Flow|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin 60 mcg/kg~Recombinant Human Prolactin :"
541890|NCT00181623|O1|Outcome|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
541891|NCT00181623|E1|Reported Event|Recombinant Human Prolactin Treatment|"Open label twice daily recombinant human prolactin~Recombinant Human Prolactin :"
541892|NCT00181610|B4|Baseline|Total|Total of all reporting groups
541893|NCT00181610|B3|Baseline|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
541894|NCT00181610|B2|Baseline|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
541895|NCT00181610|B1|Baseline|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
541896|NCT00181610|P3|Participant Flow|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours alternating with normal saline placebo given once every 24 hours"
541897|NCT00181610|P2|Participant Flow|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
541898|NCT00181610|P1|Participant Flow|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
541899|NCT00181610|O3|Outcome|Recombinant Human Prolactin Alternating With Placebo|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 24 hours Placebo given every 24 hours"
541900|NCT00181610|O2|Outcome|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
541901|NCT00181610|O1|Outcome|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
541902|NCT00181610|E3|Reported Event|Recombinant Human Prolactin Once Per Day|"Recombinant human prolactin alternating with placebo every 12 hours~Recombinant human prolactin : 60 mcg/kg given every 12 hours or every 24 hours"
541903|NCT00181610|E2|Reported Event|Recombinant Human Prolactin Twice Per Day|"Recombinant human prolactin every 12 hours~Recombinant Human Prolactin : 60 mcg/kg every 12 hours"
541904|NCT00181610|E1|Reported Event|Placebo Twice Per Day|"Placebo group~Normal Saline : twice per day"
541905|NCT00181155|B1|Baseline|Intravenous Allopurinol|We randomized patients with nonischemic cardiomyopathy in a double-blind fashion to allopurinol (300 mg intravenously) or placebo infusion, 4-to-1, the latter for purposes of blinding only. The myocardial concentrations of ATP and creatine phosphate (PCr) and the rate of adenosine triphosphate (ATP) synthesis through CK (CK flux) were determined by 31P magnetic resonance spectroscopy.
541906|NCT00181155|P2|Participant Flow|Placebo|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
541907|NCT00181155|P1|Participant Flow|Allopurinol|Each participant underwent magnetic resonance spectroscopy before and following infusion of either allopurinol 300mg or placebo.
541908|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc of 5% dextrose. Post infusion MRS data acquired on each subject.
541909|NCT00181155|O1|Outcome|Intravenous Allopurinol|Infused Aloprim 300 mg in 50cc 5% dextrose. Post MRS data acquired on each subject.
541910|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
541911|NCT00181155|O1|Outcome|Baseline|Each participant underwent baseline MRS imaging prior to infusion of Aloprim 300 mg in 50 cc of 5% Dextrose.
541912|NCT00181155|E2|Reported Event|Arm 2 - Placebo|Each participant received pre and post MRS images following infusion of 50 cc of 5% Dextrose (equivalent volume to active treatment arm).
541913|NCT00181155|E1|Reported Event|Arm 1 - Intravenous Allopurinol|Each participant received pre and post MRS images following infusion of 50 cc of Aloprim 300mg in 5% Dextrose.
541914|NCT00180687|B5|Baseline|Total|Total of all reporting groups
541915|NCT00180687|B4|Baseline|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541916|NCT00180687|B3|Baseline|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541917|NCT00180687|B2|Baseline|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541918|NCT00180687|B1|Baseline|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541919|NCT00180687|P4|Participant Flow|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541920|NCT00180687|P3|Participant Flow|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541921|NCT00180687|P2|Participant Flow|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
543753|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
541922|NCT00180687|P1|Participant Flow|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541923|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541924|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541925|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541926|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541927|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541928|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541929|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541930|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541931|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541932|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541933|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541934|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541935|NCT00180687|O4|Outcome|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541936|NCT00180687|O3|Outcome|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541937|NCT00180687|O2|Outcome|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541938|NCT00180687|O1|Outcome|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541939|NCT00180687|E4|Reported Event|Injected Bupivacaine Intraperitoneally|"Intraperitoeal Injected 10 mls.Bupivacaine (Marcaine) (No nebulised Bupivacaine)~Injected Bupivacaine intraperitoneally: Injected Marcaine directly into the peritoneal cavity"
541940|NCT00180687|E3|Reported Event|Nebulised Bupivacaine Intraperitoneally|"Intraperitoneal Nebulised 10mls. Bupivacaione (Marcaine)~Nebulised Bupivacaine intraperitoneally: Nebulised Marcaine (Bupivacaine)"
541941|NCT00180687|E2|Reported Event|IP Aerosolized Normal Saline|"Intraperitoneal nebulised 10mls. Normal Saline (No nebulised Bupivacaine)~Normal Saline: Nebulised Normal Saline"
541942|NCT00180687|E1|Reported Event|Control|"No intraperitoneal therapeutics (No nebulised Bupivacaine)~No Intraperitoneal Therapeutics: No Intraperitoneal Therapeutics given"
541943|NCT00180479|B3|Baseline|Total|Total of all reporting groups
541944|NCT00180479|B2|Baseline|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541945|NCT00180479|B1|Baseline|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541946|NCT00180479|P2|Participant Flow|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541947|NCT00180479|P1|Participant Flow|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541948|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541949|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541950|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541951|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541952|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541953|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541954|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541955|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541956|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541957|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541958|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541959|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542003|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541960|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541961|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541962|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541963|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541964|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541965|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541966|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541967|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541968|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541969|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541970|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541971|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541972|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541973|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541974|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541975|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541976|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541977|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541978|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541979|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541980|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541981|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541982|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541983|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541984|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541985|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541986|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541987|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541988|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541989|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541990|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541991|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541992|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541993|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541994|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541995|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541996|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541997|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
541998|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
541999|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542000|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542001|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542002|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542004|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542005|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542006|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542007|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542008|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542009|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542010|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542011|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542012|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542013|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542014|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542015|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542016|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542017|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542018|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542019|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542020|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542021|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542022|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542023|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542024|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542025|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542026|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542027|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542028|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542029|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542030|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542031|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542032|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542033|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542034|NCT00180479|O2|Outcome|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542035|NCT00180479|O1|Outcome|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542036|NCT00180479|E2|Reported Event|TAXUS® EXPRESS2™ ECSS|TAXUS® EXPRESS2™ Paclitaxel Eluting Coronary Stent System. 1 patient randomized never signed consent, therefore no data collected. Taxus analysis group = 332.
542037|NCT00180479|E1|Reported Event|XIENCE V® EECSS|XIENCE V® Everolimus Eluting Coronary Stent System
542038|NCT00180323|B1|Baseline|Group 1|
542039|NCT00180323|P1|Participant Flow|Group 1|
542040|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
542041|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|6 minute walktest (6 MWT) was performed before implant (baseline ), 3months and 6 months Follow-up.
542042|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Optimal AV-Delay will be measured at implant (baseline ), 3months and 6 months Follow-up for intrinsic heart rate, and 10, 20 and 30 Bpm above intrinsic heart rate.
542043|NCT00180323|O1|Outcome|Cardiac Resynchronization Therapy ICD (Renewal CRT)|Velocity time integral will be measured at implant (baseline), 3 months and 6 months Follow-up. Measurements will be taken at each timepoint at intrinsic heart rate and 10, 20 and 30 Bpm above intrinsic heart rate (paced rhythm)
542044|NCT00180323|E1|Reported Event|Group 1|
542045|NCT00180271|B3|Baseline|Total|Total of all reporting groups
542111|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542112|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542046|NCT00180271|B2|Baseline|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
542047|NCT00180271|B1|Baseline|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
542048|NCT00180271|P2|Participant Flow|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
542049|NCT00180271|P1|Participant Flow|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
542050|NCT00180271|O2|Outcome|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
542051|NCT00180271|O1|Outcome|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
542052|NCT00180271|E2|Reported Event|Implantable Cardioverter Defibrillator Alone|Patients randomized to implantable cardioverter defibrillator (ICD) in addition to optimal pharmacologic therapy (as administered by the primary care physician). ICDs deliver shocks to terminate potentially lethal ventricular arrhythmias.
542053|NCT00180271|E1|Reported Event|Cardiac Resynchronization Therapy + Defibrillator|Patients randomized to cardiac resynchronization therapy with backup defibrillation (CRT-D) in addition to optimal pharmacologic therapy (as administered by the primary care physician). CRT-D devices both deliver shocks to terminate potentially lethal ventricular arrhythmias and pace both ventricles in patients with ventricular dyssynchrony.
542054|NCT00179959|B3|Baseline|Total|Total of all reporting groups
542055|NCT00179959|B2|Baseline|Placebo|Intranasal petrolatum ointment treatment and plain water baths
542056|NCT00179959|B1|Baseline|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
542057|NCT00179959|P2|Participant Flow|Placebo|Intranasal petrolatum ointment treatment and plain water baths
542058|NCT00179959|P1|Participant Flow|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
542059|NCT00179959|O2|Outcome|Placebo|Intranasal petrolatum ointment treatment and plain water baths
542060|NCT00179959|O1|Outcome|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
542061|NCT00179959|E2|Reported Event|Placebo|Intranasal petrolatum ointment treatment and plain water baths
542062|NCT00179959|E1|Reported Event|Treatment|Intranasal mupirocin ointment treatment and sodium hpochlorite (bleach baths)
542063|NCT00179673|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542064|NCT00179673|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542065|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542066|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542067|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542068|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542069|NCT00179673|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542070|NCT00179673|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542071|NCT00179660|B1|Baseline|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542072|NCT00179660|P1|Participant Flow|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542113|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542114|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542073|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542074|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542075|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542076|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542077|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542078|NCT00179660|O1|Outcome|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542079|NCT00179660|E1|Reported Event|Lenalidomide|Participants received single-agent lenalidomide 25 mg orally once daily on Days 1 to 21 of every 28-day cycle for up to 52 weeks or until disease progression developed, lenalidomide treatment was discontinued for any reason, or the study was terminated.
542080|NCT00179647|B1|Baseline|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
542081|NCT00179647|P1|Participant Flow|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
542082|NCT00179647|O1|Outcome|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
542083|NCT00179647|E1|Reported Event|Lenalidomide|This was a multicenter, non-randomized, open-label, uncontrolled, single-arm treatment study of lenalidomide as monotherapy or in combination with dexamethasone in subjects with previously treated relapsed or refractory multiple myeloma, with measurable myeloma paraprotein in serum and/or urine. Subjects who met all of the eligibility criteria were enrolled into the study. Screening procedures took place within 28 days of first dose. Subjects who qualified for participation received oral lenalidomide at a dose of 25 mg daily for 21 days every 28 days.
542084|NCT00179621|B4|Baseline|Total|Total of all reporting groups
542085|NCT00179621|B3|Baseline|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542086|NCT00179621|B2|Baseline|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542087|NCT00179621|B1|Baseline|Placebo|Placebo matching to active study arms.
542088|NCT00179621|P4|Participant Flow|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
542089|NCT00179621|P3|Participant Flow|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542090|NCT00179621|P2|Participant Flow|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542091|NCT00179621|P1|Participant Flow|Placebo|Placebo matching to active study arms.
542092|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542093|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542094|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542095|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542096|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542097|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542098|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542099|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542100|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542101|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542102|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542103|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542104|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542105|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542106|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542107|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542108|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542109|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542110|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542116|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542117|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542118|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542119|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542120|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542121|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542122|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542123|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542124|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542125|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542126|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542127|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542128|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542129|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542130|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542131|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542132|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542133|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542134|NCT00179621|O3|Outcome|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542135|NCT00179621|O2|Outcome|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542136|NCT00179621|O1|Outcome|Placebo|Placebo matching to active study arms.
542137|NCT00179621|E4|Reported Event|Placebo Crossover to 5 mg Open-label Period|Participants receiving placebo in the Double-Blind phase and Lenalidomide in the Open-Label phase.
542138|NCT00179621|E3|Reported Event|Lenalidomide 10 mg|Lenalidomide 10 mg daily for 21 of 28 days
542139|NCT00179621|E2|Reported Event|Lenalidomide 5 mg|Lenalidomide 5 mg daily for 28 days
542140|NCT00179621|E1|Reported Event|Placebo|Placebo matching to active study arms.
542141|NCT00179309|B3|Baseline|Total|Total of all reporting groups
542142|NCT00179309|B2|Baseline|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
542143|NCT00179309|B1|Baseline|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
542144|NCT00179309|P2|Participant Flow|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin 1(MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
542145|NCT00179309|P1|Participant Flow|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V: given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
542146|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
542147|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
542171|NCT00178711|B1|Baseline|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
542148|NCT00179309|O2|Outcome|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
542149|NCT00179309|O1|Outcome|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
542150|NCT00179309|E2|Reported Event|Arm II - Docetaxel Alone|"Patients receive docetaxel as in arm I. After week 12, patients with disease progression discontinue docetaxel and receive vaccinia-carcinoembryonic antigen (CEA)- mucin (MUC-1)-triad of costimulatory molecules (TRICOM) vaccine, fowlpox-CEA-MUC-1-TRICOM vaccine, and sargramostim, or granulocyte macrophage colony stimulating factor(GM-CSF) as in arm I until further disease progression. Patients with no disease progression after week 12 continue with docetaxel as in arm I until disease progression.~Docetaxel : given intravenous (IV)"
542151|NCT00179309|E1|Reported Event|Arm I - PANVAC + Docetaxel|"Patients receive vaccinia-carcinoembryonic antigen (CEA)- mucin-1 (MUC-1)- triad of costimulatory molecules (TRICOM) vaccine subcutaneously (SC) once and sargramostim, or granulocyte macrophage colony stimulating factor (GM-CSF) SC once daily for 4 days in week -2. Patients also receive fowlpox-CEA-MUC-1-TRICOM vaccine SC once and GM-CSF SC once daily for 4 days in weeks 1, 5, and 9. Patients also receive docetaxel intravenous (IV) over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11. After week 12, patients with no disease progression continue with docetaxel once weekly for 3 weeks followed by 1 week of rest and fowlpox-CEA-MUC-1-TRICOM vaccine plus GM-CSF every 4 weeks until disease progression.~PANVAC-V : given subcutaneously~Sargramostim : given subcutaneously (NCI subjects only)~PANVAC-F : given subcutaneously~Docetaxel : given IV"
542152|NCT00178919|B3|Baseline|Total|Total of all reporting groups
542153|NCT00178919|B2|Baseline|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
542154|NCT00178919|B1|Baseline|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
542155|NCT00178919|P2|Participant Flow|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
542156|NCT00178919|P1|Participant Flow|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
542157|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
542158|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
542159|NCT00178919|O2|Outcome|Hypertensives and Controls|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system
542160|NCT00178919|O1|Outcome|Autonomic Failure Patients|To compare the effects of NO inhibition during intact and transient pharmacological blockade of the autonomic nervous system.
542161|NCT00178919|E2|Reported Event|Hypertensives and Controls|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (250, 500 mcg/kg/min) for 15 minutes each dose after acute transient pharmacological blockade of the autonomic nervous system with trimethaphan (4 mg/min) or with the autonomic nervous system intact.
542162|NCT00178919|E1|Reported Event|Autonomic Failure Patients|The NO synthase inhibitor L-NMMA was infused intravenously at different doses (125, 250 and 500 mcg/kg/min) until a systolic blood pressure of 150 mm Hg was reached.
542163|NCT00178841|B1|Baseline|Single Arm Study|All enrolled patients received rosiglitazone in addition to oral bexarotene
542164|NCT00178841|P1|Participant Flow|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
542165|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
542166|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|Patients maintained their dose of bexarotene during the study and added rosiglitazone. The initial dose of rosiglitazone was 4 mg once daily. If patients showed no response after 1 month and experienced no adverse effects, the dose was increased to a maximum of 8 mg once daily. Dose reductions of rosiglitazone or bexarotene were allowed during the study, but only if necessary to control AEs.
542167|NCT00178841|O1|Outcome|Rosiglitazone and Bexarotene|All 4 enrolled patients received rosiglitazone in addition to oral bexarotene.
542168|NCT00178841|E1|Reported Event|Rosiglitazone and Bexarotene|All enrolled patients received rosiglitazone in addition to oral bexarotene.
542169|NCT00178711|B3|Baseline|Total|Total of all reporting groups
542170|NCT00178711|B2|Baseline|Control|Treated at normothermia
542172|NCT00178711|P2|Participant Flow|Control|45 patients who had none of the second set of exclusion criteria and who has been randomized to normothermia served as the control group
542173|NCT00178711|P1|Participant Flow|Hypothermia|"There were two sets of exclusion criteria-one in the field; the other after resuscitation in the ER. In the field, patients were excluded for suspected pregnancy, systolic blood pressure <110 mm Hg, diastolic blood pressure <60 mm Hg, sustained heart rate >120 beats per minute, or failure to be reached by study-affiliated personnel within 2.5 hours of injury.~Those that did not have any of the first set of exclusion criteria were further assessed for the presence of Glasgow Coma Scale 3-8 without life-threatening associated injuries. The second set of exclusion criteria were GCS 3 with nonreactive pupils, GCS 7-8 with normal brain CT scan, inability to obtain an accurate GCS, Abbreviated Injury Severity Score >4 for organs other than brain4, systolic blood pressure <110 mm Hg or diastolic blood pressure <60 mm Hg, persistent hypoxia, (oxygen saturation < 94%), or positive pregnancy test."
542174|NCT00178711|O2|Outcome|Control|treated at normothermia
542175|NCT00178711|O1|Outcome|Hypothermia|"Induction and maintenance of moderate hypothermia to 33 degrees celsius achieved within 4 hours of injury and maintained for 48 hours.~Hypothermia: Induction of moderate hypothermia to 33 degrees celsius, within 4 hours from time of injury and maintained for 48 hours"
542176|NCT00178711|E4|Reported Event|Randomized to Normothermia Then Excluded|Maintenance of normothermia before trauma evaluation in ED and then excluded by second set of criteria
542177|NCT00178711|E3|Reported Event|Randomized to Hypothermia and Then Excluded|Induction and maintenance of moderate hypothermia before trauma evaluation in ED and then excluded by second set of criteria
542178|NCT00178711|E2|Reported Event|Randomized to Normothermia and Normothermia Maintained|Induction and maintenance of normothermia and not excluded by second set of exclusion criteria
542179|NCT00178711|E1|Reported Event|Randomized to Hypothermia and Hypothermia Maintained|Induction and maintenance of moderate hypothermia and not excluded by second set of exclusion criteria
542180|NCT00178685|B4|Baseline|Total|Total of all reporting groups
542181|NCT00178685|B3|Baseline|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
542182|NCT00178685|B2|Baseline|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
542183|NCT00178685|B1|Baseline|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
542184|NCT00178685|P3|Participant Flow|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
542185|NCT00178685|P2|Participant Flow|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
542186|NCT00178685|P1|Participant Flow|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
542187|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
542188|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
542189|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
542215|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542557|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542190|NCT00178685|O3|Outcome|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
542191|NCT00178685|O2|Outcome|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker's autonomy.
542192|NCT00178685|O1|Outcome|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
542193|NCT00178685|E3|Reported Event|Harm Reduction (HR)|The HR condition had the same features as EAS, but offered initiation of a first-line smoking cessation medication if unwilling to stop, but willing to reduce their cigarettes by half. Subjects were informed that there is no evidence to suggest that reducing cigarette use improves health, but that doing so might increase their confidence in stopping.
542194|NCT00178685|E2|Reported Event|Extended Autonomy Support (EAS|The EAS condition provided the same content as CC, but the intervention was extended: (1) from 6 to12 months; (2) to include 8 contacts (six in first 6 months and two in second 6-months); (3) by encouraging smokers to attend treatment, even if not ready to stop; and (4) by asking the smoker to bring an important other (non-health-care professional) to one 50-minute instructional session about how to support the smoker’s autonomy.
542195|NCT00178685|E1|Reported Event|Community Care|The CC condition was similar to the translated 6-month SDT and PHS Guideline-based intensive intervention validated in the previous trial and provided for the CC subjects who wanted to make a quit attempt. The clinical endpoint was to guide the subjects to be fully autonomous about stopping smoking, including not stopping if not willing to stop smoking. Once willing to stop, the Tobacco Dependence Counselor (TDC, 4 contacts) worked to provide problem solving and skills training as recommended in the PHS Guideline (Chapter 4) and the prescriber (2 visits) guided the subjects to be fully autonomous about use of effective medications. Those not wanting to stop within 30 days of the first appointment were asked to call back when ready.
542196|NCT00178633|B1|Baseline|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542197|NCT00178633|P1|Participant Flow|Bariatric Surgery|
542198|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542199|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542200|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542201|NCT00178633|O1|Outcome|Bariatric Surgery|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542202|NCT00178633|E2|Reported Event|Bariatric Surgery, Follow up at 2 Years|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542203|NCT00178633|E1|Reported Event|Bariatric Surgery, Follow up at 9 Months|Procedure was not part of research. Patients had already elected to undergo gastric procedure, agreed to follow up for research purposes.
542204|NCT00178503|B1|Baseline|MPH Trial|24 Participants with ASD-ADHD underwent 1 week of placebo, 1 week of Low dose, 1 week of Medium dose, and 1 week of High dose in the MPH treatment phase
542205|NCT00178503|P1|Participant Flow|MPH Trial|24 participants with autism spectrum disorder and ADHD underwent a randomized, placebo-controlled, cross-over designed trial, which included: 1 week of placebo, 1 week of low dose methylphenidate, 1 week of medium dose methylphenidate, 1 week of high dose methylphenidate.
542206|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542207|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542208|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542209|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
542210|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|Participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542211|NCT00178503|O3|Outcome|MPH Trial: Med Dose Week|Participants with ASD-ADHD underwent 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542212|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|Participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542213|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|Participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
542214|NCT00178503|O4|Outcome|MPH Trial: High Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phasephase
542376|NCT00176917|P1|Participant Flow|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542216|NCT00178503|O2|Outcome|MPH Trial: Low Dose Week|All 24 participants with ASD-ADHD underwent 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542217|NCT00178503|O1|Outcome|MPH Trial-Placebo Week|All 24 participants with ASD-ADHD underwent 1 week of placebo in the MPH treatment phase
542218|NCT00178503|E4|Reported Event|MPH Trial: High Dose|Participants with ASD-ADHD who will undergo 1 week at a high dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542219|NCT00178503|E3|Reported Event|MPH Trial: Med Dose|Participants with ASD-ADHD who will undergo 1 week at a medium dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542220|NCT00178503|E2|Reported Event|MPH Trial: Low Dose|Participants with ASD-ADHD who will undergo 1 week at a low dose of Methylphenidate-extended release and Methylphenidate-immediate release in the MPH treatment phase
542221|NCT00178503|E1|Reported Event|MPH Trial-Placebo|Participants with ASD-ADHD who will undergo 1 week of placebo in the MPH treatment phase
542222|NCT00178477|B1|Baseline|Group 1|MRI with Breath Hold
542223|NCT00178477|P1|Participant Flow|Breath Hold|MRI with Breath Hold
542224|NCT00178477|O1|Outcome|Group 1|MRI with Breath Hold
542225|NCT00178477|E1|Reported Event|Group 1|MRI with Breath Hold
542226|NCT00178464|B1|Baseline|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
542227|NCT00178464|P1|Participant Flow|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
542228|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
542229|NCT00178464|O1|Outcome|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
542230|NCT00178464|E1|Reported Event|Aspirin|Aspirin 81 mg flavored chewable tablets. Subjects between the ages of 2.0 and 4.99 years will receive half of an 81 mg aspirin tablet each day. Those older than 5.0 years will receive a daily 81 mg aspirin tablet. The subject will receive the study drug for a period of 12 months.
542231|NCT00178256|B1|Baseline|Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
542232|NCT00178256|P4|Participant Flow|Phase II Group (20mg/m2 Taxol)|"Once the MTD has been determined and confirmed with a total of six patients, up to 19 additional patients with measurable disease will be enrolled at that dose in order to obtain estimates of response rate and more information about toxicity Phase II enrollment will be in two stages. Initially 9 or 12 patients (depending on how many were tested at the MTD dose in the Phase I study) will be tested, for a total of 15 patients at the MTD. If fewer than 4 responses are observed, the study will end with 90% confidence that the true response rate is no greater than 40%, which is the minimum clinically interesting response rate.~If four or more responses are observed, additional patients will be enrolled to obtain 25 evaluable patients at the MTD. This will allow estimation of the true response rate and toxicity rates with standard errors of no more than 0.1."
542233|NCT00178256|P3|Participant Flow|Third Dose Cohort (25mg/m2 Taxol) MWF and Daily RT|"A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
542234|NCT00178256|P2|Participant Flow|Second Dose Cohort (20mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
542235|NCT00178256|P1|Participant Flow|First Dose Cohort (15mg/m2 Taxol) MWF and Daily RT|"On Mondays, Wednesdays, and Fridays, paclitaxel infusion will given. On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given.~A minimum of three patients will be assigned at each dose level.~If no DLTs are observed then the next three patients enrolled will receive a dose of 5 mg/m2 per dose more than the previous group.~If one or two instances of DLT are observed then an additional three patients will be tested at the same dose. If DLT is observed in at most two of six patients then dose escalation will continue in the next three patients enrolled.~Dose-limiting toxicity (DLT) is defined as grade 4 hematologic toxicity, or grade 3 and 4 non-hematologic toxicity excluding nausea and vomiting according to RTOG and Cooperative Group common toxicity criteria. The adverse event must be related to the treatment (paclitaxel or radiation) to be considered a DLT"
542377|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
543754|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
542236|NCT00178256|O1|Outcome|All Pts Enrolled Daily RT Plus Chemo on MWF|"Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Radiation Therapy : Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel : On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am."
542237|NCT00178256|O3|Outcome|3rd Dose Cohort --25mg/m2 Taxol Plus RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
542238|NCT00178256|O2|Outcome|2nd Dose cohort20 mg/m2 Taxol Plus Daily RT|"Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
542239|NCT00178256|O1|Outcome|1st Dose Cohort 15mg/m2 Taxol Plus RT|"15 mg/m2 Paclitaxel On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~On Monday, Tuesday, Wednesday, Thursday, Friday Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible~Paclitaxel: On Mondays, Wednesdays, and Fridays, paclitaxel infusion will begin early in the morning and complete before 10:30 am.~Radiation Therapy: Thoracic XRT will be given in late afternoon, after 4:00 PM, if possible"
542240|NCT00178256|E1|Reported Event|All Subjects Enrolled|
542241|NCT00178191|B4|Baseline|Total|Total of all reporting groups
542242|NCT00178191|B3|Baseline|Placebo|Placebo
542243|NCT00178191|B2|Baseline|300 Units Botox|300 units Botulinum-A toxin
542244|NCT00178191|B1|Baseline|200 Units Botox|200 units Botulinum-A toxin
542245|NCT00178191|P3|Participant Flow|Placebo|Placebo
542246|NCT00178191|P2|Participant Flow|300 Units Botox|300 units Botulinum-A toxin
542247|NCT00178191|P1|Participant Flow|200 Units Botox|200 units Botulinum-A toxin
542248|NCT00178191|O3|Outcome|Placebo|Placebo
542249|NCT00178191|O2|Outcome|300 Units Botox|300 units Botulinum-A toxin
542250|NCT00178191|O1|Outcome|200 Units Botox|200 units Botulinum-A toxin
542251|NCT00178191|E3|Reported Event|Placebo|Placebo
542252|NCT00178191|E2|Reported Event|300 Units Botox|300 units Botulinum-A toxin
542253|NCT00178191|E1|Reported Event|200 Units Botox|200 units Botulinum-A toxin
542254|NCT00178178|B5|Baseline|Total|Total of all reporting groups
542255|NCT00178178|B4|Baseline|Placebo Comparator|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542256|NCT00178178|B3|Baseline|Drug: Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542257|NCT00178178|B2|Baseline|Drug: Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542258|NCT00178178|B1|Baseline|Drug: Intraarticularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542259|NCT00178178|P4|Participant Flow|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542260|NCT00178178|P3|Participant Flow|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542261|NCT00178178|P2|Participant Flow|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542262|NCT00178178|P1|Participant Flow|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542263|NCT00178178|O4|Outcome|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542264|NCT00178178|O3|Outcome|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542265|NCT00178178|O2|Outcome|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542266|NCT00178178|O1|Outcome|Intraarticulary Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542267|NCT00178178|E4|Reported Event|Placebo|"Receive liquid with no pain medication (placebo) through a catheter in one part of the operative knee via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542309|NCT00177671|P1|Participant Flow|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542268|NCT00178178|E3|Reported Event|Patellar Tendon Harvest Site and Intraarticular|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the Patellar Tendon Harvest Site and Intraarticular infusion via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542269|NCT00178178|E2|Reported Event|Patellar Tendon Harvest Site Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) at the patellar tendon harvest site via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542270|NCT00178178|E1|Reported Event|Intraartciularly Only|"Continuous infusion of a local anesthetic agent (bupivicaine 0.5%) intraarticularly only via Breg Pain Care 3000 Catheter~Breg Pain Care 3000 Catheter: Pump that is designed to deliver local anesthetic directly to surgical site for several days."
542271|NCT00177970|B3|Baseline|Total|Total of all reporting groups
542272|NCT00177970|B2|Baseline|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542273|NCT00177970|B1|Baseline|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542274|NCT00177970|P2|Participant Flow|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542275|NCT00177970|P1|Participant Flow|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542276|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542277|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542278|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542279|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542280|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542281|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542282|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542283|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542284|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542285|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542286|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542287|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542288|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542289|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542290|NCT00177970|O2|Outcome|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542291|NCT00177970|O1|Outcome|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542292|NCT00177970|E2|Reported Event|Placebo|Placebo: Placebo to be given IV to patients with C-Diff
542293|NCT00177970|E1|Reported Event|IVIG|intravenous immunoglobulin G (IVIG): IVIG to be given IV to patients with C-Diff .
542294|NCT00177866|B3|Baseline|Total|Total of all reporting groups
542295|NCT00177866|B2|Baseline|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
542296|NCT00177866|B1|Baseline|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
542297|NCT00177866|P2|Participant Flow|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
542298|NCT00177866|P1|Participant Flow|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
542299|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
542300|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
542301|NCT00177866|O2|Outcome|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
542302|NCT00177866|O1|Outcome|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
542303|NCT00177866|E2|Reported Event|Placebo Followed by Celebrex|"Placebo PO BID for the first 8 weeks, followed by a 1 week washout period then Celebrex 200 mg PO BID for the remaining 8 weeks."
542304|NCT00177866|E1|Reported Event|Celebrex Followed by Placebo|"either placebo PO BID for the first eight weeks or Celebrex 200 mg PO BID for the first eight weeks~Celebrex: Celebrex 200 mg PO BID for the first 8 weeks, followed by a 1 week washout period then placebo PO BID for the remaining 8 weeks -"
542305|NCT00177671|B3|Baseline|Total|Total of all reporting groups
542306|NCT00177671|B2|Baseline|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542307|NCT00177671|B1|Baseline|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542308|NCT00177671|P2|Participant Flow|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542310|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542311|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542312|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542313|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542314|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542315|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542316|NCT00177671|O2|Outcome|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542317|NCT00177671|O1|Outcome|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542318|NCT00177671|E2|Reported Event|Placebo|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus placebo
542319|NCT00177671|E1|Reported Event|Donepezil|Treatment with antidepressants (escitalopram (10mg to 20mg daily), venlafaxine (150mg to 300mg daily), duloxetine(20mg to 120mg daily) plus donepezil (5mg to 10mg daily)
542320|NCT00177307|B1|Baseline|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542321|NCT00177307|P1|Participant Flow|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542322|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542323|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542324|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542325|NCT00177307|O1|Outcome|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542326|NCT00177307|E1|Reported Event|Oxaliplatin, Capecitabine, and Bevacizumab|"Bevacizumab: Bevacizumab 5 mg/kg by 90-30 minute IV infusion IV q 2 weekly Until disease progression or unacceptable toxicity~Capecitabine: Capecitabine will be administered orally at twice daily 1250 mg/m2 (equivalent to a total daily dose of 2500 mg/m2) as intermittent therapy (1 week of treatment followed by one week without treatment) and this cycle repeated every 14 days. The first dose of capecitabine will be given on day 1 of each cycle as evening dose and the last dose will be given on day 8 as morning dose (for a total of 14 single doses per cycle).~Oxaliplatin: Oxaliplatin will be administered at the dose of 85 mg/m2 given as a 2-hour intravenous infusion on day 1 of a two-week cycle, prior to the first dose of capecitabine"
542328|NCT00177294|B2|Baseline|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
542329|NCT00177294|B1|Baseline|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
542330|NCT00177294|P2|Participant Flow|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
542331|NCT00177294|P1|Participant Flow|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
542332|NCT00177294|O2|Outcome|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
542333|NCT00177294|O1|Outcome|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
542334|NCT00177294|E2|Reported Event|Escitalopram Plus Depression Care Management (DCM)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly depression care management without interpersonal psychotherapy (IPT)
542335|NCT00177294|E1|Reported Event|Escitalopram Plus Interpersonal Psychotherapy (IPT)|Participants who respond partially to 6 weeks of escitalopram 10mg daily then receive 16 weeks of extension therapy with escitalopram 20 mg daily, plus weekly interpersonal psychotherapy (IPT)
542336|NCT00177255|B1|Baseline|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
542337|NCT00177255|P1|Participant Flow|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
542338|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
542339|NCT00177255|O1|Outcome|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
542340|NCT00177255|E1|Reported Event|Docetaxel + Capecitabine|"Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.~Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days. Cycle 2 will begin on day 22.~Docetaxel: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.~Cycle 2 will begin on day 22.~Capecitabine: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).~Each cycle will consist of 21 days.~Cycle 2 will begin on day 22."
542341|NCT00177216|B4|Baseline|Total|Total of all reporting groups
542342|NCT00177216|B3|Baseline|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
542378|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542379|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542343|NCT00177216|B2|Baseline|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
542344|NCT00177216|B1|Baseline|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
542345|NCT00177216|P3|Participant Flow|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
542346|NCT00177216|P2|Participant Flow|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
542347|NCT00177216|P1|Participant Flow|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
542348|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
542349|NCT00177216|O2|Outcome|Escitalopram|Participants receiving an antidepressant, escitalopram
542350|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
542351|NCT00177216|O3|Outcome|Placebo Comparator: Placebo|A placebo capsule was given with instructions to take it every night by mouth, 30 minutes prior to bedtime.
542352|NCT00177216|O2|Outcome|Experimental: Excitalopram|The antidepressant, escitalopram was initiated at 5 mg by mouth every night, 30 minutes prior to bedtime. If there were no side effects, the dose was increased every four days until the target dose of 20 mg (maximum dose) was reached by day 13. If significant side effects appeared, the highest tolerated dose was used.
542353|NCT00177216|O1|Outcome|Experimental: Zolpidem|The benzodiazepine receptor agonist (BzRA), zolpidem was given in an initial dose of 5 mg by mouth every night, 30 minutes prior to bedtime. The dose was increased to a maximum of 10 mg after the first week if there was no improvement in overall symptoms (CGI score of 4 or >). The dose was decreased to 5 mg if side effects occurred.
542354|NCT00177216|O3|Outcome|Placebo|Participants receiving a placebo
542355|NCT00177216|O2|Outcome|Escitalpram|Participants receiving an antidepressant, escitalopram
542356|NCT00177216|O1|Outcome|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
542357|NCT00177216|E3|Reported Event|Placebo|Participants receiving a placebo
542358|NCT00177216|E2|Reported Event|Escitalopram|Participants receiving an antidepressant, escitalopram
542359|NCT00177216|E1|Reported Event|Zolpidem|Participants receiving an benzodiazepine receptor agonist (BzRA), zolpidem
542360|NCT00177164|B3|Baseline|Total|Total of all reporting groups
542361|NCT00177164|B2|Baseline|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542362|NCT00177164|B1|Baseline|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542363|NCT00177164|P2|Participant Flow|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542364|NCT00177164|P1|Participant Flow|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542365|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542366|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542367|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542368|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542369|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542370|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542371|NCT00177164|O2|Outcome|Oral AAP|"Oral second generation antipsychotic agents other than clozapine or risperidone (olanzapine, quetiapine, ziprasidone, aripiprazole)~Oral antipsychotic agents, olanzapine, quetiapine, ziprasidone, aripiprazole in doses approved in the US for bipolar disorder"
542372|NCT00177164|O1|Outcome|Risperidone LAI|"Oral Risperidone followed by Long acting Risperidone injections (Consta)~Injectable Risperidone (Consta) or oral antipsychotic: Injectable Risperidone (Consta) from 12.5 to 50 mg q 2 weeks"
542373|NCT00177164|E2|Reported Event|Oral AAP|
542374|NCT00177164|E1|Reported Event|Risperidone LAI|
542375|NCT00176917|B1|Baseline|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542558|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542380|NCT00176917|O1|Outcome|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542381|NCT00176917|E1|Reported Event|Transplant Patients|Patients that received hematopoietic stem cell transplant.
542382|NCT00176904|B1|Baseline|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542383|NCT00176904|P1|Participant Flow|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542384|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542385|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542386|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542387|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542388|NCT00176904|O1|Outcome|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542389|NCT00176904|E1|Reported Event|Patients Treated With Stem Cell Transplant|All patients treated with protocol regimen (chemotherapy and stem cell transplant).
542390|NCT00176878|B1|Baseline|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542391|NCT00176878|P1|Participant Flow|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542392|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542393|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542394|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542395|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542396|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542397|NCT00176878|O1|Outcome|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542398|NCT00176878|E1|Reported Event|Bone Marrow Failure Patients|All patients with non-malignant, congenital bone marrow failure disorders and treated with stem cell transplant, chemotherapy (Busulfan, ATG, Fludarabine) and irradiation.
542399|NCT00176839|B1|Baseline|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542400|NCT00176839|P1|Participant Flow|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542401|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542402|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542403|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542404|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542405|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542406|NCT00176839|O1|Outcome|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542407|NCT00176839|E1|Reported Event|Treatment Arm|Patients treated with therapy plan ((Busulfan, Cyclophosphamide, Melphalan, antithymocyte globulin (ATG), G-CSF (granulocyte colony-stimulating factor) and stem cell transplantation.
542408|NCT00176826|B1|Baseline|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542409|NCT00176826|P1|Participant Flow|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542410|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542411|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542559|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542560|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542412|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542413|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542414|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542415|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542416|NCT00176826|O1|Outcome|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542417|NCT00176826|E1|Reported Event|Intent-To-Treat|Patients who were treated with chemotherapies (myeloablative conditioning regimen) and stem cell transplant. Busulfan intravenously for 4 days followed by cyclophosphamide intravenously for 4 days. Rabbit ATG is given intravenously for 4 doses pre-transplant.
542418|NCT00176800|B1|Baseline|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542419|NCT00176800|P1|Participant Flow|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542420|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542421|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542422|NCT00176800|O1|Outcome|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542423|NCT00176800|E1|Reported Event|Chemoradiation and Tetrathiomolybdate (TM)|"Paclitaxel is administered intravenously over 1 hour on Days 1, 8, 15, and 22. Cisplatin will then be administered intravenously over 1 hour on Days 1 and 22. Tetrathiomolybdate (TM): Tetrathiomolybdate: 20mg p.o. per day with largest meal. This will be started 4-6 weeks post-op, and continued x 2 years or until progression of disease is documented.~Radiation: Radiation treatments will be administered twice per day with each dose separated by more than 6 hours, on Days 1-5, 8-12 and 15-19.~Surgery: The persons's esophagus will be surgically removed (esophagectomy) on approximately Day #50."
542424|NCT00176644|B1|Baseline|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542425|NCT00176644|P1|Participant Flow|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542492|NCT00176202|B1|Baseline|Risperidone|"Risperidone is an antipsychotic medication and is used to treat mania. Its trade name is Risperdal.~Aim of the study is to cross compare the relative efficacy and safety of risperidone and divalproex sodium in treating/stabilizing mania in pediatric bipolar disorder."
542561|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542426|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542427|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542428|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542429|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542430|NCT00176644|O1|Outcome|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542431|NCT00176644|E1|Reported Event|Transdermal Estradiol|"Transdermal Estradiol : application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.~The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed."
542432|NCT00176631|B1|Baseline|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
542433|NCT00176631|P1|Participant Flow|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
542434|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
542435|NCT00176631|O1|Outcome|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
542436|NCT00176631|E1|Reported Event|Licorice Root Extract and Docetaxel|"licorice root extract : Licorice root is started on Day 1 and is given at a dose of 6.75 g each day (five 450 mg capsules tid) for a total of 21 days in each cycle.~docetaxel : All the patients will be treated with docetaxel at a dose of 60 mg/m2 every 21 days on Day 1 of the treatment cycle."
542437|NCT00176605|B1|Baseline|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
542438|NCT00176605|P1|Participant Flow|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
542439|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
542440|NCT00176605|O1|Outcome|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
542441|NCT00176605|E1|Reported Event|Arm 1 (Etoposide + Cyclophosphamide)|"Therapy will be divided into 4 cycles. Each cycle will be composed of 6 weeks of therapy for a total of 24 weeks. Administration of etoposide (50 mg po qd) and cyclophosphamide (50 mg po qd) will alternate in 21 day intervals. Starting with etoposide, patients will receive 21 days of therapy, upon completion of etoposide therapy patients will then receive 21 days of cyclophosphamide therapy. Week 1 of each cycle, begins with etoposide; Week 4 of each cycle, begins with cyclophosphamide.~Cyclophosphamide : 50 mg per day of cyclophosphamide orally for 21 consecutive days. Cyclophosphamide will be alternated with oral etoposide. The drug is taken 2 hours after breakfast. The patient will be asked to increase hydration throughout the day. Recommendation is at least 6, 8oz glasses of water or other non-caffeinated beverage. Week 4 of the each cycle will begin with cylcophosphamide. Chronic administration"
542442|NCT00176501|B1|Baseline|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542443|NCT00176501|P1|Participant Flow|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542444|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542445|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542446|NCT00176501|O1|Outcome|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542447|NCT00176501|E1|Reported Event|Irradiated Allogeneic Lymphocytes|therapeutic allogeneic lymphocytes : If a partially HLA-matched donor is identified and other eligibility criteria are met, the patient will receive irradiated lymphocyte infusion(s).
542448|NCT00176488|B1|Baseline|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542449|NCT00176488|P1|Participant Flow|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542450|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542451|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542452|NCT00176488|O1|Outcome|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542493|NCT00176202|P2|Participant Flow|Divalproex Sodium|This is antiepileptic medication and is a comparator drug to see if it is as efficacious as risperidone assumption is both have equal efficacy with no difference between the two.
542562|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
543755|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
542453|NCT00176488|E1|Reported Event|Sequential Epirubicin/Vinorelbine|"For patients with stage IIB (T3N0), IIIA, or IIIB breast cancer, epirubicin and vinorelbine will be administered for up to 5 cycles. For patients with stage IV breast cancer, epirubicin and vinorelbine will be administered as long as there is evidence of continued response or stable disease and no evidence of cardiac or other serious toxicities.~epirubicin : Epirubicin (100 mg/m2) will be given on Day 1~vinorelbine : Vinorelbine (18.75 mg/m2) will be given on Days 3 and 17."
542454|NCT00176462|B3|Baseline|Total|Total of all reporting groups
542455|NCT00176462|B2|Baseline|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
542456|NCT00176462|B1|Baseline|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
542457|NCT00176462|P2|Participant Flow|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
542458|NCT00176462|P1|Participant Flow|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
542459|NCT00176462|O2|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
542460|NCT00176462|O1|Outcome|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
542461|NCT00176462|O1|Outcome|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
542462|NCT00176462|E2|Reported Event|Arm 2 High Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE 6-THIOGUANINE CYTARABINE AMINOPTERIN CYCLOPHOSPHAMIDE ARABINOSIDE-C
542463|NCT00176462|E1|Reported Event|Arm 1 Standard Risk|6-MERCAPTOPURINE DAUNOMYCIN DEXAMETHASONE Triple Intrathecal Therapy (ITT) L-ASPARAGINASE VINCRISTINE METHOTREXATE Leucovorin
542464|NCT00176436|B3|Baseline|Total|Total of all reporting groups
542465|NCT00176436|B2|Baseline|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
542466|NCT00176436|B1|Baseline|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
542467|NCT00176436|P2|Participant Flow|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
542468|NCT00176436|P1|Participant Flow|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
542469|NCT00176436|O2|Outcome|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
542470|NCT00176436|O1|Outcome|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
542471|NCT00176436|E2|Reported Event|Placebo|Placebo medication, diet support group weekly and exercise sessions 3 times/week
542472|NCT00176436|E1|Reported Event|Active|Atomoxetine titrated up to 120 mg/day by week 8 and continues at 120 mg/day through week 24.
542473|NCT00176306|B1|Baseline|Levofloxacin Arm|patients receiving levofloxacin
542474|NCT00176306|P1|Participant Flow|Levofloxacin Arm|Patients receive commercially available levofloxacin 750mg solution for intravnous use
542475|NCT00176306|O1|Outcome|Levofloxacin Arm|Subjects receiving levofloxacin
542476|NCT00176306|E1|Reported Event|Levofloxacin Arm|patients receiving levofloxacin
542477|NCT00176254|B1|Baseline|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542478|NCT00176254|P1|Participant Flow|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m^2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542479|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542480|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542481|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542482|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542483|NCT00176254|O1|Outcome|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542484|NCT00176254|E1|Reported Event|Treatment Arm: Induction LDFRT and Chemotherapy|"Carboplatin : AUC of 6 will be given intravenously over 30 minutes on days 1 and 22~Paclitaxel : 225 mg/m2 intravenously over three hours on Days 1 and 22~Radiotherapy : 80 cGy on Day 1 & 2 and 22 & 23 of chemotherapy"
542485|NCT00176228|B1|Baseline|Lamotrigine|upto 200 mg
542486|NCT00176228|P1|Participant Flow|Lamotrigine|upto 200 mg
542487|NCT00176228|O1|Outcome|Lamotrigine|Lamotrigine: Response on CDRS-R
542488|NCT00176228|O1|Outcome|Lamotrigine Effectiveness on YMRS (Mania Measure)|
542489|NCT00176228|E1|Reported Event|Lamotrigine|upto 200 mg
542490|NCT00176202|B3|Baseline|Total|Total of all reporting groups
542491|NCT00176202|B2|Baseline|Divalproex|Divalproex sodium, also referred to as divalproex is an antiepileptic medication used for mania and is referred to as mood stabilizer. Its trade name is Depakote.
542494|NCT00176202|P1|Participant Flow|Risperidone|The study aimed to compare the antipsychotic medication i.e., risperidone's efficacy with that of divalproex sodium (which is an antiepileptic medication) in treating/stabilizing pediatric bipolar disorder.
542495|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
542496|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
542497|NCT00176202|O2|Outcome|Divalproex Sodium|Antiepileptic medication used as mood stabilizer/antimanic agent
542498|NCT00176202|O1|Outcome|Risperidone|Antipsychotic medication used as a anti manic agent
542499|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
542500|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
542501|NCT00176202|O2|Outcome|Risperidone|Risperidone was initiated at 0.25 mg to 0.50 mg per day. The dose was titrated to a maximum of 2 mg per day by increments of 0.25–0.5 mg every 2 days to achieve a maximum tolerable level by day 7.
542502|NCT00176202|O1|Outcome|Divalproex|Divalproex was titrated up to 15 mg/kg/day over 3 days and serum level was measured at the end of 5 days. Divalproex dose was immediately adjusted on obtaining the serum level to aim for 80–120 μg/ml- trough, while ensuring that the dose was tolerated when increased. Serum valproate level was repeated at the end of the study.
542503|NCT00176202|E2|Reported Event|Depakote or Divalproex Sodium|"Likely side effects include gastrointestinal side effects such as stomach discomfort, weight gain, agitation and sedation, fatigue or tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
542504|NCT00176202|E1|Reported Event|Risperidone|"Likely side effects include weight gain, muscle stiffness, sedation and tiredness.~Clarification: We did not note any serious side effects with either drug. We reported any adverse event that is found in greater than 5% of the participants in each group. Frequency of adverse events do not equal the fact that they are serious adverse events at any individual level."
542505|NCT00175877|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542506|NCT00175877|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542507|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542508|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542509|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542510|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542511|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542512|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542553|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542627|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542513|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542514|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542515|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542516|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542517|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542518|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542519|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542520|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542521|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542522|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542523|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542524|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542525|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542554|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542555|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542556|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542526|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542527|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542528|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542529|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542530|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542531|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542532|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542533|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542534|NCT00175877|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542535|NCT00175877|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: Lyophilized product reconstituted to 1 ml containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
542536|NCT00175019|B4|Baseline|Total|Total of all reporting groups
542537|NCT00175019|B3|Baseline|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542538|NCT00175019|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542539|NCT00175019|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542540|NCT00175019|P3|Participant Flow|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542541|NCT00175019|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542542|NCT00175019|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542543|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542544|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542545|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542546|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542547|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542548|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542549|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542550|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542551|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542552|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542563|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542564|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542565|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542566|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542567|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542568|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542569|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542570|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542571|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542572|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542573|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542574|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542575|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542576|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542577|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542578|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542579|NCT00175019|O3|Outcome|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542580|NCT00175019|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542581|NCT00175019|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542582|NCT00175019|E3|Reported Event|Allopurinol QD|Allopurinol 100 mg or 300 mg, tablets, orally, once daily.
542583|NCT00175019|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily
542584|NCT00175019|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily.
542585|NCT00175006|B1|Baseline|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
542586|NCT00175006|P1|Participant Flow|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
542587|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
542588|NCT00175006|O1|Outcome|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
542589|NCT00175006|E1|Reported Event|Tophi Participants|Participants with palpable tophi >10 millimeters (mm) in length and width and as round as possible measured on two separate visits by two different raters.
542590|NCT00174967|B5|Baseline|Total|Total of all reporting groups
542591|NCT00174967|B4|Baseline|Placebo QD|Placebo, orally, once daily
542592|NCT00174967|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542593|NCT00174967|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542594|NCT00174967|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542595|NCT00174967|P4|Participant Flow|Placebo QD|Placebo, orally, once daily
542596|NCT00174967|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542597|NCT00174967|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542598|NCT00174967|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542599|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542600|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542601|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542602|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542603|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542604|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542605|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542606|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542607|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542608|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542609|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542610|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542611|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542612|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542613|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542614|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542615|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542616|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542617|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542618|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542619|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542620|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542621|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542622|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542623|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542624|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542625|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542626|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542628|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542629|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542630|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542631|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542632|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542633|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542634|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542635|NCT00174967|O4|Outcome|Placebo QD|Placebo, orally, once daily
542636|NCT00174967|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542637|NCT00174967|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542638|NCT00174967|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542639|NCT00174967|E4|Reported Event|Placebo QD|Placebo, orally, once daily
542640|NCT00174967|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily.
542641|NCT00174967|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily.
542642|NCT00174967|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily.
542643|NCT00174954|B1|Baseline|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
542644|NCT00174954|P1|Participant Flow|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
542645|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
542646|NCT00174954|O1|Outcome|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
542647|NCT00174954|E1|Reported Event|Palpable Gouty Tophi Subjects|Volumes/measurements of tophi determined by serial MRI
542648|NCT00174941|B4|Baseline|Total|Total of all reporting groups
542649|NCT00174941|B3|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level
542650|NCT00174941|B2|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level
542651|NCT00174941|B1|Baseline|Febuxostat 40 mg QD|Febuxostat 40 mg orally, once daily, based on serum urate level.
542652|NCT00174941|P4|Participant Flow|Total Febuxostat|
542653|NCT00174941|P3|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542654|NCT00174941|P2|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542655|NCT00174941|P1|Participant Flow|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542656|NCT00174941|O4|Outcome|Total Febuxostat|
542657|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542658|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542659|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542660|NCT00174941|O4|Outcome|Total Febuxostat|
542661|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542662|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542663|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542664|NCT00174941|O4|Outcome|Total Febuxostat|
542665|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542666|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542667|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542668|NCT00174941|O4|Outcome|Total Febuxostat|
542669|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542670|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542671|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542672|NCT00174941|O4|Outcome|Total Febuxostat|
542673|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542674|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542675|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542676|NCT00174941|O4|Outcome|Total Febuxostat|
542677|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542678|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542679|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542680|NCT00174941|O4|Outcome|Total Febuxostat|
542681|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542682|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542683|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542684|NCT00174941|O4|Outcome|Total Febuxostat|
542685|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542686|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542687|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542688|NCT00174941|O4|Outcome|Total Febuxostat|
542689|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542690|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542691|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542692|NCT00174941|O4|Outcome|Total Febuxostat|
542693|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542694|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542695|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542696|NCT00174941|O4|Outcome|Total Febuxostat|
542697|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542698|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542699|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542700|NCT00174941|O4|Outcome|Total Febuxostat|
542701|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542702|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542703|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542704|NCT00174941|O4|Outcome|Total Febuxostat|
542705|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542706|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542707|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542708|NCT00174941|O4|Outcome|Total Febuxostat|
542709|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542710|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542711|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542712|NCT00174941|O4|Outcome|Total Febuxostat|
542713|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542714|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542715|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542716|NCT00174941|O4|Outcome|Total Febuxostat|
542717|NCT00174941|O3|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily, based on serum urate level.
542718|NCT00174941|O2|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily, based on serum urate level.
542719|NCT00174941|O1|Outcome|Febuxostat 40 mg QD|Febuxostat 40 mg, orally, once daily, based on serum urate level.
542720|NCT00174941|E4|Reported Event|Febuxostat Total|
542721|NCT00174941|E3|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, taken orally, once daily, based on serum urate level
542722|NCT00174941|E2|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, taken orally, once daily, based on serum urate level
542723|NCT00174941|E1|Reported Event|Febuxostat 40 mg QD|Febuxostat 40 mg taken orally, once daily, based on serum urate level.
542724|NCT00174915|B6|Baseline|Total|Total of all reporting groups
542725|NCT00174915|B5|Baseline|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542726|NCT00174915|B4|Baseline|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542727|NCT00174915|B3|Baseline|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542728|NCT00174915|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542729|NCT00174915|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542730|NCT00174915|P5|Participant Flow|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542731|NCT00174915|P4|Participant Flow|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542732|NCT00174915|P3|Participant Flow|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542733|NCT00174915|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542734|NCT00174915|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542735|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542736|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542737|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542738|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542739|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542740|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542741|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542742|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542743|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542744|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542745|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542746|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542747|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542748|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542749|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542750|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542751|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542752|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542753|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542754|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542755|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542756|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542757|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542758|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542759|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542760|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542761|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542762|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542763|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542764|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542765|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542766|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542767|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542768|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542769|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542770|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542771|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542772|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542773|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542774|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542775|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542776|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542777|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542778|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542779|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542780|NCT00174915|O5|Outcome|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542781|NCT00174915|O4|Outcome|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542782|NCT00174915|O3|Outcome|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542783|NCT00174915|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542784|NCT00174915|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542785|NCT00174915|E5|Reported Event|Placebo QD|Placebo, orally, once daily for up to 28 weeks.
542786|NCT00174915|E4|Reported Event|Allopurinol QD|Allopurinol, orally, once daily for up to 28 weeks. Dose of allopurinol received was based on renal status. Subjects with serum creatinine ≤1.5 mg/dL received 300 mg once daily; subjects with serum creatinine >1.5 mg/dL and ≤2.0 mg/dL received 100 mg once daily.
542787|NCT00174915|E3|Reported Event|Febuxostat 240 mg QD|Febuxostat 240 mg, orally, once daily for up to 28 weeks.
542788|NCT00174915|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 28 weeks.
542789|NCT00174915|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 28 weeks.
542790|NCT00174785|B3|Baseline|Total|Total of all reporting groups
542791|NCT00174785|B2|Baseline|Placebo|matching placebo tablets
542792|NCT00174785|B1|Baseline|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542794|NCT00174785|P1|Participant Flow|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542795|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
542796|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542797|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
542798|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542799|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
542800|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542801|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
542802|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542803|NCT00174785|O2|Outcome|Placebo|matching placebo tablets
542804|NCT00174785|O1|Outcome|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542805|NCT00174785|E2|Reported Event|Placebo|matching placebo tablets
542806|NCT00174785|E1|Reported Event|Dronedarone 400mg Bid|dronedarone tablets 400mg twice daily
542807|NCT00174460|B3|Baseline|Total|Total of all reporting groups
542808|NCT00174460|B2|Baseline|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542809|NCT00174460|B1|Baseline|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542810|NCT00174460|P2|Participant Flow|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542811|NCT00174460|P1|Participant Flow|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542812|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542813|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542814|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542815|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542816|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542817|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542818|NCT00174460|O1|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542819|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542820|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542821|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542822|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542823|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542824|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542825|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542849|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542826|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542827|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542828|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542829|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542830|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542831|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542832|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542833|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542834|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542835|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542836|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542837|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542838|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542839|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542840|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542841|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542842|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542843|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542844|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542845|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542846|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542847|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542848|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542922|NCT00174265|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for 26 weeks
542850|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542851|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542852|NCT00174460|O2|Outcome|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542853|NCT00174460|O1|Outcome|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542854|NCT00174460|E2|Reported Event|Control Arm|The children were randomized into control group and after 1 year underwent Growth Hormone (GH) therapy, with 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. mg=milligram, kg=kilogram.
542855|NCT00174460|E1|Reported Event|Somatropin|The children were randomized into a treated group receiving 0.068 mg/kg/day (0.48mg/kg/week) subcutaneous somatropin according to exact body weight specific calculation. Dose adjustments were made at 6 month intervals. (mg=milligrams, kg=kilograms)
542856|NCT00174447|B1|Baseline|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542857|NCT00174447|P1|Participant Flow|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542858|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542859|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542860|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542861|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542862|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542863|NCT00174447|O1|Outcome|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542864|NCT00174447|E1|Reported Event|Ziprasidone|Ziprasidone maintenance dosing of 40 to 80 milligrams twice daily
542865|NCT00174382|B1|Baseline|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542866|NCT00174382|P1|Participant Flow|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542867|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542868|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542869|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542870|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542871|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542872|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542873|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542874|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542875|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542876|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542877|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542878|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542879|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542880|NCT00174382|O1|Outcome|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542881|NCT00174382|E1|Reported Event|Donepezil|Subjects received open-label donepezil treatment with 5 mg administered per os (orally; PO)quaque die (every day; QD) for 6 weeks. Donepezil was increased to 10 mg QD (the maximum dose)at the Week-6 visit for an additional planned 18 weeks.
542882|NCT00174291|B3|Baseline|Total|Total of all reporting groups
542883|NCT00174291|B2|Baseline|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542884|NCT00174291|B1|Baseline|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542885|NCT00174291|P2|Participant Flow|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542886|NCT00174291|P1|Participant Flow|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542887|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542888|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542889|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542923|NCT00174265|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for 26 weeks
542924|NCT00174252|B1|Baseline|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
543756|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
542890|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542891|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542892|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542893|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542894|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542895|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542896|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542897|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543309|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
542898|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542899|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542900|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542901|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542902|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542903|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542904|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542905|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543310|NCT00170625|E1|Reported Event|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
542906|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542907|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542908|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542909|NCT00174291|O2|Outcome|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542910|NCT00174291|O1|Outcome|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542911|NCT00174291|E2|Reported Event|Somatropin (Without Previous Somatropin Exposure)|Participants who received matching placebo for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 mg/kg/week, equivalent to 1.8 IU/kg/week, divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 mcg/kg/day, equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 cm per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542912|NCT00174291|E1|Reported Event|Somatropin (With Previous Somatropin Exposure)|Participants who received low dose of somatropin (Genotonorm) for 3 years during previous study CTN 97-8129-016, received somatropin (Genotonorm) up to 0.6 milligram per kilogram per week (mg/kg/week), equivalent to 1.8 international units/kg/week (IU/kg/week), divided in 7 daily doses subcutaneously initially for first 3 years and then somatropin (Genotonorm) 0.46 mg/kg/week, equivalent to 1.4 IU/kg/week, divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotonorm) 50 microgram/kg/day (mcg/kg/day), equivalent to 0.35 mg/kg/week or 1.05 IU/kg/week, subcutaneously until the final height was reached or up to Year 8.5. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542913|NCT00174265|B3|Baseline|Total|Total of all reporting groups
542914|NCT00174265|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for 26 weeks
542915|NCT00174265|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for 26 weeks
542916|NCT00174265|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for 26 weeks
542917|NCT00174265|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for 26 weeks
542918|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
542919|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
542920|NCT00174265|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for 26 weeks
542921|NCT00174265|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for 26 weeks
542925|NCT00174252|P1|Participant Flow|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542926|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542927|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542928|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542929|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542930|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542931|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542932|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542933|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
542934|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
542935|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
542936|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
542937|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
542938|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
542939|NCT00174252|O2|Outcome|Genotonorm (IGF-1 > 2 SD at 9 and 12 Months)|
542940|NCT00174252|O1|Outcome|Genotonorm (IGF-1 < = 2 SD at 9 or 12 Months)|
542941|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542942|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542943|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542944|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542945|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542946|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542947|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542948|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542949|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542950|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542951|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542952|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542953|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542954|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542955|NCT00174252|O1|Outcome|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542956|NCT00174252|E1|Reported Event|Genotonorm|Initiated at a dose of 0.40 milligrams (mg)/kilograms (kg) of Genotonorm divided in 7 daily subcutaneous injections and titrated as needed.
542957|NCT00174187|B3|Baseline|Total|Total of all reporting groups
542958|NCT00174187|B2|Baseline|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542959|NCT00174187|B1|Baseline|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542960|NCT00174187|P3|Participant Flow|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542961|NCT00174187|P2|Participant Flow|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542962|NCT00174187|P1|Participant Flow|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542963|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
542964|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542965|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542966|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542967|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542968|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542969|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542970|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542971|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542972|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542973|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542974|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542975|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542976|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542977|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542978|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543311|NCT00170157|B1|Baseline|Entire Study Population|All participants initially randomized.
542979|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542980|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542981|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542982|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542983|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542984|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542985|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542986|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542987|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542988|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542989|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542990|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542991|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542992|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542993|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542994|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542995|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542996|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542997|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542998|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
542999|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543000|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543001|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543002|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543003|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543004|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543005|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543006|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543007|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543008|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543009|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543010|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543011|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543012|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543013|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543034|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543355|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543014|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543015|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543016|NCT00174187|O1|Outcome|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543017|NCT00174187|O2|Outcome|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543018|NCT00174187|O1|Outcome|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543019|NCT00174187|E3|Reported Event|Somatropin- After Year 3|Participants with JIA/NeS, who consented to receive treatment beyond 3 years, received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week divided in 7 daily doses subcutaneously until the additional study drug dose evaluation visit and thereafter received somatropin (Genotropin, Genotonorm) up to 50 microgram (mcg)/kg/day subcutaneously until the final height (FH) was reached or up to Year 11. Final height was confirmed to have been achieved if the growth velocity was less than or equal to 1.5 centimeter (cm) per year during the preceding 12 months and bone age was greater than or equal to 17 years for boys and 15 years for girls.
543020|NCT00174187|E2|Reported Event|Somatropin- Up To Year 3 (Nephrotic Syndrome)|Participants with nephrotic syndrome (NeS) received somatropin (Genotropin, Genotonorm) 1.4 IU/kg/week, equivalent to 0.46 mg/kg/week, divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543021|NCT00174187|E1|Reported Event|Somatropin- Up To Year 3 (Juvenile Idiopathic Arthritis)|Participants with juvenile idiopathic arthritis (JIA) received somatropin (Genotropin, Genotonorm) 1.4 International Units per kilogram per week (IU/kg/week), equivalent to 0.46 milligram/kg/week (mg/kg/week), divided in 7 daily doses subcutaneously for up to 3 years. After treatment for 3 years, participants in this group were assigned to Somatropin- After Year 3 group.
543022|NCT00172042|B3|Baseline|Total|Total of all reporting groups
543023|NCT00172042|B2|Baseline|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543024|NCT00172042|B1|Baseline|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543025|NCT00172042|P2|Participant Flow|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543026|NCT00172042|P1|Participant Flow|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543027|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543028|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543029|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543030|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543031|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543032|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543033|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543035|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543036|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543037|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543038|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543039|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543040|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543041|NCT00172042|O2|Outcome|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543042|NCT00172042|O1|Outcome|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543043|NCT00172042|E2|Reported Event|Control|No investigational treatment. If a participant developed bone metastases, treatment was started with Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks until 24 months from the date of study entry had elapsed.
543044|NCT00172042|E1|Reported Event|Zoledronic Acid|Zoledronic acid 4 mg intravenous infusion over at least 15 minutes every 3 to 4 weeks for 24 months. Dosage was adjusted for participants with mild or moderate renal impairment.
543045|NCT00171925|B3|Baseline|Total|Total of all reporting groups
543046|NCT00171925|B2|Baseline|Control|No Treatment with study medication.
543047|NCT00171925|B1|Baseline|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543048|NCT00171925|P2|Participant Flow|Control|No Treatment with study medication.
543049|NCT00171925|P1|Participant Flow|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543050|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
543051|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543052|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
543053|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543054|NCT00171925|O2|Outcome|Control|No Treatment with study medication.
543055|NCT00171925|O1|Outcome|Zoledronic Acid (ZOL446)|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543056|NCT00171925|E2|Reported Event|Control|No treatment with study medication.
543057|NCT00171925|E1|Reported Event|Zoledronic Acid|Participants received intravenous infusion of Zoledronic acid every 4 weeks for 48 weeks, and calcium and Vitamin D daily.
543058|NCT00171873|B3|Baseline|Total|Total of all reporting groups
543059|NCT00171873|B2|Baseline|Placebo|Sodium chloride intramuscularly every 28 days
543060|NCT00171873|B1|Baseline|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
543061|NCT00171873|P2|Participant Flow|Placebo|Sodium chloride intramuscularly every 28 days
543062|NCT00171873|P1|Participant Flow|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
543063|NCT00171873|O2|Outcome|Placebo|Sodium chloride intramuscularly every 28 days
543064|NCT00171873|O1|Outcome|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
543065|NCT00171873|E2|Reported Event|Placebo|Sodium chloride intramuscularly every 28 days
543066|NCT00171873|E1|Reported Event|Octreotide LAR (SMS995)|Octreotide LAR (Long-acting release) 30 mg intramuscularly every 28 days
543067|NCT00171834|B8|Baseline|Total|Total of all reporting groups
543068|NCT00171834|B7|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543069|NCT00171834|B6|Baseline|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543070|NCT00171834|B5|Baseline|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543071|NCT00171834|B4|Baseline|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543072|NCT00171834|B3|Baseline|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543073|NCT00171834|B2|Baseline|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543074|NCT00171834|B1|Baseline|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543740|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543075|NCT00171834|P7|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC w.BM Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543076|NCT00171834|P6|Participant Flow|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543077|NCT00171834|P5|Participant Flow|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543078|NCT00171834|P4|Participant Flow|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543079|NCT00171834|P3|Participant Flow|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543080|NCT00171834|P2|Participant Flow|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543081|NCT00171834|P1|Participant Flow|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543082|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
543083|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
543084|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
543085|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
543086|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
543087|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
543088|NCT00171834|O1|Outcome|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543089|NCT00171834|O13|Outcome|Patupilone 13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543090|NCT00171834|O12|Outcome|Patupilone 12.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543091|NCT00171834|O11|Outcome|Patupilone 11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543092|NCT00171834|O10|Outcome|Patupilone 11.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543093|NCT00171834|O9|Outcome|Patupilone 10.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543094|NCT00171834|O8|Outcome|Patupilone 10.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543095|NCT00171834|O7|Outcome|Patupilone 9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543096|NCT00171834|O6|Outcome|Patupilone 9.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543097|NCT00171834|O5|Outcome|Patupilone 8.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543098|NCT00171834|O4|Outcome|Patupilone 8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543099|NCT00171834|O3|Outcome|Patupilone 7.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543100|NCT00171834|O2|Outcome|Patupilone 7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543101|NCT00171834|O1|Outcome|Patupilone 6.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543102|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
543103|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
543104|NCT00171834|O2|Outcome|Patupilone (EPO906) Phase II|
543105|NCT00171834|O1|Outcome|Patupilone (EPO906) Phase I|
543106|NCT00171834|O5|Outcome|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543107|NCT00171834|O4|Outcome|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543108|NCT00171834|O3|Outcome|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543109|NCT00171834|O2|Outcome|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543110|NCT00171834|O1|Outcome|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543111|NCT00171834|E7|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC w. Brain Metastases (BM)|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543112|NCT00171834|E6|Reported Event|Patupilone 10 mg/m^2 (Phase II) NSCLC Cohort|Patupilone was administered as a single i.v. infusion over 20 minutes (Amendment 4), once every 3 weeks.
543113|NCT00171834|E5|Reported Event|Patupilone 12.0-13.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543114|NCT00171834|E4|Reported Event|Patupilone 10.0-11.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543115|NCT00171834|E3|Reported Event|Patupilone 8.5-9.5 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543116|NCT00171834|E2|Reported Event|Patupilone 7.5-8.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543117|NCT00171834|E1|Reported Event|Patupilone ≤7.0 mg/m^2 (Phase I)|Patupilone was administered as a single i.v. infusion over 5 to 10 minutes (Amendment 1) until (Amendment 2) and over 10 to 20 minutes (Amendment 2) until the completion of Phase I part of the study.
543118|NCT00171704|B3|Baseline|Total|Total of all reporting groups
543119|NCT00171704|B2|Baseline|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543120|NCT00171704|B1|Baseline|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543121|NCT00171704|P2|Participant Flow|Tam-Let|Tamoxifen 20 mg once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543122|NCT00171704|P1|Participant Flow|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543123|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543124|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543125|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543126|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543127|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543128|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543129|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543130|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543131|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543132|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543133|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543134|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543135|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543136|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543137|NCT00171704|O2|Outcome|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543138|NCT00171704|O1|Outcome|Letrozole|2.5 mg once daily (q.d.)orally for 5 years
543139|NCT00171704|E2|Reported Event|Tam-Let|20 mg Tamoxifen once daily (q.d.) orally for 2 years followed by Letrozole 2.5 mg q.d. orally for 3 years.
543140|NCT00171704|E1|Reported Event|Letrozole|2.5 mg once daily q.d. orally for 5 years
543141|NCT00172185|B5|Baseline|Total|Total of all reporting groups
543142|NCT00172185|B4|Baseline|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543143|NCT00172185|B3|Baseline|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543144|NCT00172185|B2|Baseline|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543145|NCT00172185|B1|Baseline|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543146|NCT00172185|P4|Participant Flow|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543147|NCT00172185|P3|Participant Flow|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543148|NCT00172185|P2|Participant Flow|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543149|NCT00172185|P1|Participant Flow|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543150|NCT00172185|O4|Outcome|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
543151|NCT00172185|O3|Outcome|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
543152|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
543153|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
543154|NCT00172185|O4|Outcome|0.10/0.10|Received Teduglutide 0.10 mg/kg/d in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543155|NCT00172185|O3|Outcome|0.05/0.05|Received Teduglutide 0.05 mg/kg/d in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543156|NCT00172185|O2|Outcome|Placebo/0.10|Received placebo in Study 004/ Received Teduglutide 0.10 mg/kg/d in Study 005
543157|NCT00172185|O1|Outcome|Placebo/0.05|Received placebo in Study 004/ Received Teduglutide 0.05 mg/kg/d in Study 005
543158|NCT00172185|E4|Reported Event|0.10/0.10|Received teduglutide 0.10 mg/kg/d in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
543159|NCT00172185|E3|Reported Event|0.05/0.05|Received teduglutide 0.05 mg/kg/d in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
543160|NCT00172185|E2|Reported Event|Placebo/0.10|Received placebo in Study 004/ Received teduglutide 0.10 mg/kg/d in Study 005
543161|NCT00172185|E1|Reported Event|Placebo/0.05|Received placebo in Study 004/ Received teduglutide 0.05 mg/kg/d in Study 005
543162|NCT00171340|B3|Baseline|Total|Total of all reporting groups
543163|NCT00171340|B2|Baseline|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543164|NCT00171340|B1|Baseline|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543165|NCT00171340|P2|Participant Flow|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543166|NCT00171340|P1|Participant Flow|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543167|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543168|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543169|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
543170|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
543171|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
543172|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
543173|NCT00171340|O2|Outcome|Zolendronic Acid 4 mg Delayed|
543174|NCT00171340|O1|Outcome|Zolendronic Acid 4 mg Upfront|
543175|NCT00171340|O2|Outcome|Zoledronic Acid 4 mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543176|NCT00171340|O1|Outcome|Zoledronic Acid 4 mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543177|NCT00171340|E2|Reported Event|Zolendronic Acid 4mg Delayed|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543178|NCT00171340|E1|Reported Event|Zoledronic Acid 4mg Upfront|Zolendronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1 and Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543179|NCT00171314|B3|Baseline|Total|Total of all reporting groups
543180|NCT00171314|B2|Baseline|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543181|NCT00171314|B1|Baseline|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543182|NCT00171314|P2|Participant Flow|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543183|NCT00171314|P1|Participant Flow|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543184|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543185|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543186|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543187|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543741|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543188|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543189|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543190|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543191|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543192|NCT00171314|O2|Outcome|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543193|NCT00171314|O1|Outcome|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543194|NCT00171314|E2|Reported Event|Delayed Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months beginning when one of the following occurred: BMD T-score <= -2.0 SD at either the lumbar spine or total hip, any clinical fracture unrelated to trauma or an asymptomatic fracture discovered at the Month 36 visit. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1.
543195|NCT00171314|E1|Reported Event|Upfront Zoledronic Acid|Zoledronic acid 4 mg Intravenous (IV) 15 minute infusion every 6 months for 5 years beginning on Day 1. All participants took Letrozole tablets 2.5 mg/day for 5 years beginning on Day 1
543196|NCT00171301|B3|Baseline|Total|Total of all reporting groups
543197|NCT00171301|B2|Baseline|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543198|NCT00171301|B1|Baseline|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543199|NCT00171301|P2|Participant Flow|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543200|NCT00171301|P1|Participant Flow|Deferasirox (Between 2 <16 Years )|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543201|NCT00171301|O1|Outcome|Deferasirox (All Participants)|Participants received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543202|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543203|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543204|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543205|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543206|NCT00171301|O2|Outcome|Deferasirox (16 Years or Older)|Participants age 16 years or older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543207|NCT00171301|O1|Outcome|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient's body weight.
543239|NCT00171210|E2|Reported Event|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543208|NCT00171301|E2|Reported Event|Deferasirox (16 Years or Older)|Participants age 16 years and older received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543209|NCT00171301|E1|Reported Event|Deferasirox (Between 2 <16 Years)|Participants age 2 years up to 16 years received a daily oral dose of deferasirox. Dose selection was based on the dose last received in the core study. The individual daily doses of deferasirox and the exact amount of tablets (125, 250, or 500 mg) contributing to each dose were calculated by the investigator based on the patient’s body weight.
543210|NCT00171210|B3|Baseline|Total|Total of all reporting groups
543211|NCT00171210|B2|Baseline|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543212|NCT00171210|B1|Baseline|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543213|NCT00171210|P2|Participant Flow|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543214|NCT00171210|P1|Participant Flow|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543215|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543216|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543217|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543218|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543219|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543220|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543221|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543222|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543223|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543224|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543225|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543226|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543227|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543228|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543229|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543230|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543231|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543232|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543233|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543234|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543235|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543236|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543237|NCT00171210|O2|Outcome|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study and continued this treatment in the extension study. Dosage based on body weight.
543238|NCT00171210|O1|Outcome|Crossover|Participants treated with Deferoxamine (DFO) during the core study and crossed over to receive Deferasirox (ICL670) orally once a day during the extension study. Dosage based on body weight.
543742|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543240|NCT00171210|E1|Reported Event|ICL670|Participants treated with Deferasirox (ICL670) orally once a day during the core study continued this treatment in the extension study. Dosage based on body weight.
543241|NCT00171054|B3|Baseline|Total|Total of all reporting groups
543242|NCT00171054|B2|Baseline|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543243|NCT00171054|B1|Baseline|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543244|NCT00171054|P2|Participant Flow|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543245|NCT00171054|P1|Participant Flow|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543246|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543247|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543248|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543249|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543250|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543251|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543252|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543253|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543254|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543255|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543256|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543257|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543258|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543259|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543260|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543261|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543262|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543263|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543264|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543265|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543266|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543267|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543268|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543269|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543270|NCT00171054|O2|Outcome|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543271|NCT00171054|O1|Outcome|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543272|NCT00171054|E2|Reported Event|Amlodipine 10 mg|Amlodipine, orally administered, was provided as 5 mg capsules. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543307|NCT00170625|P1|Participant Flow|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21 Carboplatin AUC 5 on day 3, q 21
543308|NCT00170625|O1|Outcome|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
543273|NCT00171054|E1|Reported Event|Valsartan 320 mg|Double-blind study medication consisted of valsartan 160 mg capsules for oral administration. Open-label HCTZ 12.5 mg (orally administered) was electively prescribed at week 12.
543274|NCT00170950|B3|Baseline|Total|Total of all reporting groups
543275|NCT00170950|B2|Baseline|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543276|NCT00170950|B1|Baseline|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543277|NCT00170950|P2|Participant Flow|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543278|NCT00170950|P1|Participant Flow|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543279|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543280|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543281|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543282|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543283|NCT00170950|O2|Outcome|Benazepril/Hydrochlorothiazide|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1 from Day 1 to Month 1), 40/12.5 mg (Dose Level 2 from Month 1 to Month 2), and 40/25 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543284|NCT00170950|O1|Outcome|Benazepril/Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1 from Day 1 to Month 1), 40/5 mg (Dose Level 2 from Month 1 to Month 2), and 40/10 mg (Dose Level 3 from Month 2 to Month 3 and thereafter) capsules for oral administration once daily
543285|NCT00170950|E2|Reported Event|Benazepril / HCTZ|Benazepril hydrochloride (HCl)/hydrochlorothiazide (HCTZ): 20/12.5 mg (Dose Level 1), 40/12.5 mg (Dose Level 2), and 40/25 mg (Dose Level 3) capsules for oral administration once daily
543286|NCT00170950|E1|Reported Event|Benazepril / Amlodipine|Benazepril hydrochloride (HCl)/amlodipine besylate: 20/5 mg (Dose Level 1), 40/5 mg (Dose Level 2), and 40/10 mg (Dose Level 3) capsules for oral administration once daily
543287|NCT00170846|B4|Baseline|Total|Total of all reporting groups
543288|NCT00170846|B3|Baseline|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543289|NCT00170846|B2|Baseline|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543290|NCT00170846|B1|Baseline|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543291|NCT00170846|P3|Participant Flow|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543292|NCT00170846|P2|Participant Flow|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543293|NCT00170846|P1|Participant Flow|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543294|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543295|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543296|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543297|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543298|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543299|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543300|NCT00170846|O3|Outcome|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543301|NCT00170846|O2|Outcome|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543302|NCT00170846|O1|Outcome|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543303|NCT00170846|E3|Reported Event|Group C: CNI Reduction|Initiation of everolimus (3-8 ng/mL) with reduction by 70-90% in CNI blood levels. Everolimus (RAD001) 3 mg initial daily dose.
543304|NCT00170846|E2|Reported Event|Group B : CNI Withdrawal|Initiation of everolimus (8-12 ng/mL) with discontinuation of CNI. Everolimus (RAD001) 4 mg initial daily dose.
543305|NCT00170846|E1|Reported Event|Group A: No RAD|Calcineurin Inhibitors (CNI) ± Mycophenolate Acid (MPA)/Azathioprine (AZA) ± Steroids
543306|NCT00170625|B1|Baseline|Hycamtin|Topotecan 1mg/m2/d on day 1-3, q 21d
543312|NCT00170157|P2|Participant Flow|Androgen Ablative (AA) Then AA Therapy + MDX-010|"3 months of initial AA therapy alone~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily."
543313|NCT00170157|P1|Participant Flow|Androgen Ablative (AA) Therapy + MDX-010|"3 months of concurrent androgen ablative (AA) therapy + MDX-010~Androgen ablative (AA) therapy is received a combined regimen of GnRH agonist and androgen receptor blocker. GnRH agonists must be in the form of a 1 month depot of either leuprolide acetate (Lupron) 7.5 mg intramuscular (IM), or goserelin acetate (Zoladex) 3.6 mg subcutaneous (SC) and will be administered on Day 0 (baseline), Day 28 and Day 56. Androgen receptor blockade may be provided by oral administration of either flutamide (Eulexin) 250 mg orally 3 times daily, or bicalutamide (Casodex) 50 mg orally once daily.~MDX-010 is received as an infusion at a dose of 3.0 mg/kg on day 7."
543314|NCT00170157|O1|Outcome|Entire Study Population|All participants initially randomized.
543315|NCT00170157|O1|Outcome|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone) initially randomized (i.e., before cross-over) were grouped together for this outcome.
543316|NCT00170157|E1|Reported Event|Entire Study Population|All participants (Androgen ablative (AA) therapy + MDX-010 and Androgen ablative (AA) therapy alone the AA Therapy + MDX-010) were grouped together for this outcome.
543317|NCT00168844|B4|Baseline|Total|Total of all reporting groups
543318|NCT00168844|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543319|NCT00168844|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543320|NCT00168844|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543321|NCT00168844|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543322|NCT00168844|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543323|NCT00168844|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543324|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543325|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543326|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543327|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543328|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543329|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543330|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543331|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543332|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543333|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543334|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543335|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543336|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543337|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543338|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543339|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543340|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543341|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543342|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543343|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543344|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543345|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543346|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543347|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543348|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543349|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543350|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543351|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543352|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543353|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543354|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543356|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543357|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543358|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543359|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543360|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543361|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543362|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543363|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543364|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543365|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543366|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543367|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543368|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543369|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543370|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543371|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543372|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543373|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543374|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543375|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543376|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543377|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543378|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543379|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543380|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543381|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543382|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543383|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543384|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543385|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543386|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543387|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543388|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543389|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543390|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543391|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543392|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543393|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543394|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543395|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543396|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543397|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543398|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543399|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543400|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543401|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543402|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543403|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543404|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543405|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543406|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543407|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543408|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543409|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543410|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543411|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543412|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543413|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543414|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543415|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543416|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543417|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543418|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543419|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543420|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543421|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543422|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543423|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543424|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543425|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543426|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543427|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543428|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543429|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543430|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543431|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543432|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543433|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543434|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543435|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543436|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543437|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543438|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543439|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543440|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543441|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543442|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543443|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543444|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543445|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543446|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543447|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543448|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543449|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543450|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543451|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543452|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543453|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543454|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543455|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543456|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543457|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543458|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543459|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543460|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543461|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543462|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543463|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543464|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543465|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543466|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543467|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543468|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543469|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543470|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543471|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543472|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543473|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543474|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543475|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543476|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543477|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543478|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543479|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543480|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543481|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543482|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543483|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543484|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543485|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543486|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543487|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543488|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543489|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543490|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543491|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543492|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543493|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543494|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543495|NCT00168844|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543496|NCT00168844|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543497|NCT00168844|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543498|NCT00168844|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543499|NCT00168844|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543500|NCT00168844|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543501|NCT00168831|B4|Baseline|Total|Total of all reporting groups
543502|NCT00168831|B3|Baseline|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543503|NCT00168831|B2|Baseline|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543504|NCT00168831|B1|Baseline|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543505|NCT00168831|P3|Participant Flow|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543506|NCT00168831|P2|Participant Flow|Tiotropium Respimat 10mcg (Tio R10)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543507|NCT00168831|P1|Participant Flow|Tiotropium Respimat 5mcg (Tio R5)|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543508|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543509|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543510|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543511|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543512|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543513|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543514|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543515|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543516|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543517|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543518|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543519|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543520|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543521|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543522|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543523|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543524|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543525|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543526|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543527|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543528|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543529|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543530|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543531|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543532|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543533|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543534|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543535|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543536|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543537|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543538|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543539|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543540|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543541|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543542|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543543|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543544|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543545|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543546|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543547|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543548|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543549|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543550|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543551|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543552|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543553|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543554|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543555|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543556|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543557|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543558|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543559|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543560|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543561|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543562|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543563|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543564|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543565|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543566|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543567|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543568|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543569|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543570|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543571|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543572|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543573|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543574|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543575|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543576|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543577|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543578|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543579|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543580|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543581|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543582|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543583|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543584|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543585|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543586|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543587|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543588|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543589|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543590|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543591|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543592|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543593|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543594|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543595|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543596|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543597|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543598|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543599|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543600|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543601|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543602|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543603|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543604|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543605|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543606|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543607|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543608|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543609|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543610|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543611|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543612|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543613|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543614|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543615|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543616|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543617|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543618|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543619|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543620|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543621|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543622|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543623|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543624|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543625|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543626|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543627|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543628|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543629|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543630|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543631|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543632|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543633|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543634|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543635|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543636|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543637|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543638|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543639|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543640|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543641|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543642|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543643|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543644|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543645|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543646|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543647|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543648|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543649|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543650|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543651|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543652|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543653|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543654|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543655|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543656|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543657|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543658|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543659|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543660|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543661|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543662|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543663|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543664|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543665|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543666|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543667|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543668|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543669|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543670|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543671|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543672|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543673|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543674|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543675|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543676|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543677|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543678|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543679|NCT00168831|O3|Outcome|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543680|NCT00168831|O2|Outcome|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543681|NCT00168831|O1|Outcome|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543682|NCT00168831|E3|Reported Event|Placebo|Placebo inhalation solution delivered from Respimat Inhaler (matching placebo)
543683|NCT00168831|E2|Reported Event|Tiotropium Respimat 10mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (10 mcg)
543684|NCT00168831|E1|Reported Event|Tiotropium Respimat 5mcg|Tiotropium Bromide inhalation solution delivered from Respimat Inhaler (5 mcg)
543685|NCT00168818|B4|Baseline|Total|Total of all reporting groups
543686|NCT00168818|B3|Baseline|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543687|NCT00168818|B2|Baseline|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543688|NCT00168818|B1|Baseline|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543689|NCT00168818|P3|Participant Flow|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543690|NCT00168818|P2|Participant Flow|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543691|NCT00168818|P1|Participant Flow|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543692|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543693|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543694|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543695|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543696|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543697|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543698|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543699|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543700|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543701|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543702|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543703|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543704|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543705|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543706|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543707|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543708|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543709|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543710|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543711|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543712|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543713|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543714|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543715|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543716|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543717|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543718|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543719|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543720|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543721|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543722|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543723|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543724|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543725|NCT00168818|O3|Outcome|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543726|NCT00168818|O2|Outcome|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543727|NCT00168818|O1|Outcome|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543728|NCT00168818|E3|Reported Event|Enoxaparin|Patients were treated with 40mg Enoxaparin once daily for subcutaneous injection and placebo capsules. Placebo capsules matching the dabigatran capsules.
543729|NCT00168818|E2|Reported Event|Dabigatran 150mg|Patients were treated with 150mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543730|NCT00168818|E1|Reported Event|Dabigatran 220mg|Patients were treated with 220mg dabigatran etexilate once daily as capsules for oral administration and placebo subcutaneous injections. Placebo injections matching the enoxaparin syringes.
543731|NCT00168805|B4|Baseline|Total|Total of all reporting groups
543732|NCT00168805|B3|Baseline|Enoxaparin|40mg qd (once daily) subcutaneous
543733|NCT00168805|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
543734|NCT00168805|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
543735|NCT00168805|P3|Participant Flow|Enoxaparin|40mg qd (once daily) subcutaneous
543736|NCT00168805|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
543737|NCT00168805|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
543738|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543739|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543757|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543758|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543759|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543760|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543761|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543762|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543763|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543764|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543765|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543766|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543767|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543768|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543769|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543770|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543771|NCT00168805|O3|Outcome|Enoxaparin|40mg qd (once daily) subcutaneous
543772|NCT00168805|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
543773|NCT00168805|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
543774|NCT00168805|E3|Reported Event|Enoxaparin|40mg qd (once daily) subcutaneous
543775|NCT00168805|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
543776|NCT00168805|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
543777|NCT00168454|B7|Baseline|Total|Total of all reporting groups
543778|NCT00168454|B6|Baseline|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543779|NCT00168454|B5|Baseline|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543780|NCT00168454|B4|Baseline|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543781|NCT00168454|B3|Baseline|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543782|NCT00168454|B2|Baseline|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543783|NCT00168454|B1|Baseline|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543784|NCT00168454|P6|Participant Flow|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543785|NCT00168454|P5|Participant Flow|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543786|NCT00168454|P4|Participant Flow|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543787|NCT00168454|P3|Participant Flow|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543788|NCT00168454|P2|Participant Flow|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543789|NCT00168454|P1|Participant Flow|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543790|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543791|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543792|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543793|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543794|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543795|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543796|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543797|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543798|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543799|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543800|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543801|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543802|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543803|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543804|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543805|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543806|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543807|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543808|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543809|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543810|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543811|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543812|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543813|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543814|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543815|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543816|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543817|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543818|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543819|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543820|NCT00168454|O6|Outcome|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543821|NCT00168454|O5|Outcome|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543822|NCT00168454|O4|Outcome|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543823|NCT00168454|O3|Outcome|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543824|NCT00168454|O2|Outcome|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543825|NCT00168454|O1|Outcome|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543826|NCT00168454|E6|Reported Event|BOTOX 300 U|botulinum toxin Type A 300 U injection on Day 1 into detrusor
543827|NCT00168454|E5|Reported Event|BOTOX 200 U|botulinum toxin Type A 200 U injection on Day 1 into detrusor
543828|NCT00168454|E4|Reported Event|BOTOX 150 U|botulinum toxin Type A 150 U injection on Day 1 into detrusor
543829|NCT00168454|E3|Reported Event|BOTOX 100 U|botulinum toxin Type A 100 U injection on Day 1 into detrusor
543830|NCT00168454|E2|Reported Event|BOTOX 50 U|botulinum toxin Type A 50 U injection on Day 1 into detrusor
543831|NCT00168454|E1|Reported Event|Placebo|Placebo (normal saline)injection on Day 1 into detrusor
543832|NCT00168428|B3|Baseline|Total|Total of all reporting groups
543833|NCT00168428|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543834|NCT00168428|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543835|NCT00168428|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543836|NCT00168428|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543837|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543838|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543839|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543840|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543841|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543842|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543843|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543844|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543845|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543846|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543847|NCT00168428|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543848|NCT00168428|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543849|NCT00168428|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
543850|NCT00168428|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
543851|NCT00168389|B4|Baseline|Total|Total of all reporting groups
543852|NCT00168389|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543853|NCT00168389|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543985|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
543854|NCT00168389|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543855|NCT00168389|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543856|NCT00168389|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543857|NCT00168389|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543858|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543859|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543860|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543861|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543862|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543863|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543864|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543865|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543866|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543867|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543868|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543869|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543870|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543871|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543872|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543873|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543874|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543875|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543876|NCT00168389|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543877|NCT00168389|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543878|NCT00168389|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543879|NCT00168389|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543880|NCT00168389|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543881|NCT00168389|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543882|NCT00166296|B3|Baseline|Total|Total of all reporting groups
543883|NCT00166296|B2|Baseline|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543884|NCT00166296|B1|Baseline|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543885|NCT00166296|P2|Participant Flow|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543886|NCT00166296|P1|Participant Flow|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543887|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543888|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543889|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543890|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543891|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543892|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543893|NCT00166296|O2|Outcome|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543894|NCT00166296|O1|Outcome|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543895|NCT00166296|E2|Reported Event|Placebo|Patients treated with placebo since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543896|NCT00166296|E1|Reported Event|Escitalopram|Patients treated with 15 mg/day of Escitalopram since 2 weeks before starting pegylated interferon and ribavirin until week 12 of antiviral treatment
543897|NCT00166205|B1|Baseline|Swedish Adjustable Gastric Band (SAGB)|
543898|NCT00166205|P1|Participant Flow|Swedish Adjustable Gastric Band (SAGB)|
543899|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543900|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543901|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543902|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543903|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543904|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543905|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543906|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543907|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543908|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543909|NCT00166205|O1|Outcome|Swedish Adjustable Gastric Band (SAGB)|
543910|NCT00166205|E1|Reported Event|Swedish Adjustable Gastric Band (SAGB)|
543911|NCT00168337|B4|Baseline|Total|Total of all reporting groups
543912|NCT00168337|B3|Baseline|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543913|NCT00168337|B2|Baseline|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543914|NCT00168337|B1|Baseline|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543915|NCT00168337|P3|Participant Flow|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543916|NCT00168337|P2|Participant Flow|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543917|NCT00168337|P1|Participant Flow|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543918|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543919|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543920|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543921|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543922|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543923|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543924|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543925|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543926|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543927|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543928|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543929|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543930|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543931|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543932|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543933|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543934|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543935|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543936|NCT00168337|O3|Outcome|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543937|NCT00168337|O2|Outcome|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543938|NCT00168337|O1|Outcome|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543939|NCT00168337|E3|Reported Event|Sham|Sham posterior segment drug delivery system - needle-less drug delivery system without study medication not less than every 6 months for up to 36 months.
543940|NCT00168337|E2|Reported Event|Dexamethasone 350 μg|350 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543941|NCT00168337|E1|Reported Event|Dexamethasone 700 μg|700 µg Dexamethasone posterior segment drug delivery system - injection into the vitreous cavity not less than every 6 months for up to 36 months.
543942|NCT00168324|B4|Baseline|Total|Total of all reporting groups
543943|NCT00168324|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543944|NCT00168324|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543945|NCT00168324|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
543946|NCT00168324|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543947|NCT00168324|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543948|NCT00168324|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
543949|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
543950|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543951|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
543952|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
543953|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543954|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
543955|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
543956|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543957|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
543958|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
543959|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543960|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
543961|NCT00168324|O3|Outcome|Sham Injection|Sham injection on Day 0.
543962|NCT00168324|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543963|NCT00168324|O1|Outcome|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0.
543964|NCT00168324|E3|Reported Event|Sham Injection|Sham injection on Day 0.
543965|NCT00168324|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543966|NCT00168324|E1|Reported Event|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
543967|NCT00168311|B3|Baseline|Total|Total of all reporting groups
543968|NCT00168311|B2|Baseline|Sham Treatment|Sham bilateral rTMS treatment
543969|NCT00168311|B1|Baseline|Active Treatment|Bilateral high frequency (10Hz) rTMS
543970|NCT00168311|P2|Participant Flow|Sham Treatment|Sham bilateral rTMS treatment
543971|NCT00168311|P1|Participant Flow|Active Treatment|Bilateral high frequency (10Hz) rTMS
543972|NCT00168311|O2|Outcome|Sham Treatment|Sham bilateral rTMS treatment
543973|NCT00168311|O1|Outcome|Active Treatment|Bilateral high frequency (10Hz) rTMS
543974|NCT00168311|E2|Reported Event|Sham Treatment|Sham bilateral rTMS treatment
543975|NCT00168311|E1|Reported Event|Active Treatment|Bilateral high frequency (10Hz) rTMS
543976|NCT00168298|B4|Baseline|Total|Total of all reporting groups
543977|NCT00168298|B3|Baseline|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543978|NCT00168298|B2|Baseline|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543979|NCT00168298|B1|Baseline|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
543980|NCT00168298|P3|Participant Flow|Sham Injection Followed by 700 µg Dexamethasone|Sham injection on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543981|NCT00168298|P2|Participant Flow|350 µg Dexamethasone Followed by 700 µg Dexamethasone|350 µg dexamethasone intravitreal implant administered on Day 0 and 700 µg dexamethasone intravitreal implant on Day 180.
543982|NCT00168298|P1|Participant Flow|700 µg Dexamethasone|700 µg dexamethasone intravitreal implant administered on Day 0 and Day 180.
543983|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
543984|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543986|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
543987|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543988|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
543989|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
543990|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543991|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
543992|NCT00168298|O3|Outcome|Sham Injection|Sham injection on Day 0.
543993|NCT00168298|O2|Outcome|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543994|NCT00168298|O1|Outcome|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
543995|NCT00168298|E3|Reported Event|Sham Injection|Sham injection on Day 0.
543996|NCT00168298|E2|Reported Event|350 µg Dexamethasone|350 µg Dexamethasone intravitreal implant administered on Day 0.
543997|NCT00168298|E1|Reported Event|700 µg Dexamethasone|700 µg Dexamethasone intravitreal implant administered on Day 0.
543998|NCT00168103|B4|Baseline|Total|Total of all reporting groups
543999|NCT00168103|B3|Baseline|Placebo|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the Placebo arm were included in the ITT analysis population.
544000|NCT00168103|B2|Baseline|C1-INH 20 U/kg bw|Baseline data presented here are for subjects included in the ITT population. All subjects enrolled and randomized to the C1-INH 20 U/kg bw arm were included in the ITT analysis population.
544001|NCT00168103|B1|Baseline|C1-INH 10 U/kg bw|Baseline characteristics were calculated only for the intention to treat (ITT) and per protocol (PP) analysis populations, not for all enrolled subjects. Baseline data presented here are for subjects included in the ITT population. One (1) subject enrolled and randomized to the C1-INH 10 U/kg bw group was excluded from the ITT analysis population.
544002|NCT00168103|P4|Participant Flow|Not Randomized|Includes one subject enrolled who was not randomized but received treatment with 20 U/kg bw C1-INH.
544003|NCT00168103|P3|Participant Flow|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544004|NCT00168103|P2|Participant Flow|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544005|NCT00168103|P1|Participant Flow|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1 Esterase Inhibitor (C1-INH) 10 Units (U)/kg body weight (bw) arm.
544006|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544007|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544008|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
544009|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544010|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544011|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
544012|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544013|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544014|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
544015|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544016|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544017|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
544018|NCT00168103|O3|Outcome|Placebo|Includes all subjects enrolled and randomized to the Placebo arm.
544019|NCT00168103|O2|Outcome|C1-INH 20 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 20 U/kg bw arm.
544020|NCT00168103|O1|Outcome|C1-INH 10 U/kg bw|Includes all subjects enrolled and randomized to the C1-INH 10 U/kg bw arm.
544021|NCT00168103|E3|Reported Event|Placebo|Includes subjects receiving Placebo and no rescue study medication within 4 hours after the start of the initial treatment.
544022|NCT00168103|E2|Reported Event|C1-INH 20 U/kg bw|Includes subjects receiving 20 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment (n=43). An additional 3 subjects not randomized to but treated with 20 U/kg bw C1-INH in this time period were also included in this group for the safety analysis.
544023|NCT00168103|E1|Reported Event|C1-INH 10 U/kg bw|Includes subjects receiving 10 U/kg bw C1-INH and no rescue study medication within 4 hours after the start of the initial treatment.
544024|NCT00168064|B3|Baseline|Total|Total of all reporting groups
544025|NCT00168064|B2|Baseline|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
544026|NCT00168064|B1|Baseline|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
544027|NCT00168064|P2|Participant Flow|AP- Mechlorethamine 0.02% Compounded in Aquaphor|Compounded Mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
544028|NCT00168064|P1|Participant Flow|PG -Mechlorethamine (Nitrogen Mustard) 0.02% PG Gel|Study formulation of Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
544029|NCT00168064|O2|Outcome|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard) in Aquaphor 0.02%
544030|NCT00168064|O1|Outcome|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
544031|NCT00168064|O2|Outcome|AP- Aquaphor Formulation Mechlorethamine-MCH (NM) 0.02%|Mechlorethamine-MCH (Nitrogen Mustard) compounded in Aquaphor 0.02%
544032|NCT00168064|O1|Outcome|PG- Mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
544033|NCT00168064|E2|Reported Event|AP- Mechlorethamine-MCH (NM) 0.02% Compounded in Aquaphor|Compounded mechlorethamine-MCH (Nitrogen Mustard)in Aquaphor 0.02%
544186|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg daily
544034|NCT00168064|E1|Reported Event|PG -Mechlorethamine-MCH (Nitrogen Mustard) 0.02% PG Gel|Study formulation of mechlorethamine-MCH (Nitrogen Mustard) 0.02% Gel
544035|NCT00168038|B1|Baseline|IgPro10|All subjects treated with IgPro10
544036|NCT00168038|P1|Participant Flow|IgPro10|All subjects treated with IgPro10
544037|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544038|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544039|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544040|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544041|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544042|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544043|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544044|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544045|NCT00168038|O1|Outcome|IgPro10|All subjects treated with IgPro10
544046|NCT00168038|E1|Reported Event|IgPro10|All subjects treated with IgPro10
544047|NCT00167778|B1|Baseline|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
544048|NCT00167778|P1|Participant Flow|Amputee|This is a randomized cross-over study. Each participant wore both study prostheses: (1) a rigid pylon and (2) a transverse plane torsion adapter. The torsion adapter was initially set according to the manufacturer's recommendations based on body mass and activity level. After one week of acclimation, additional stiffness adjustments were made based on participant feedback. This process continued until the perceived stiffness was optimized. All participants were able to find a comfortable fit either on the first or second visit. Subjects were then randomized, provided with one of two study prostheses, and asked to wear it for 3 weeks. Data was then collected during lab visit 1, and following 1 more week, additional data was collected during lab visit 2. Subjects were then provided with the second study prosthesis and asked to wear it for 3 weeks. Data was then collected during lab visit 3, and following 1 more week, additional data was collected during lab visit 4.
544049|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544050|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544051|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544052|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544053|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544054|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544055|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544056|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544057|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544058|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544059|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544060|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544061|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544062|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544063|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544064|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544065|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544066|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544067|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544068|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544069|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544070|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544071|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544187|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
544072|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544073|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544074|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544075|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544076|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544077|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544078|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544079|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544080|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544081|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544082|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544083|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544084|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544085|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544086|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544087|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544088|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544089|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544090|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544091|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544092|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544093|NCT00167778|O2|Outcome|Torsion Adapter Pylon|A torsion adapter pylon is a prosthetic component that connects the prosthetic socket to the prosthetic foot and includes a device that allows transverse plane rotation at the socket-pylon interface.
544094|NCT00167778|O1|Outcome|Rigid Pylon|A rigid pylon is a non-flexible prosthetic component that connects the prosthetic socket to the prosthetic foot.
544095|NCT00167778|E1|Reported Event|Amputee|Lower limb amputees who wore both rigid and torsion adapter pylons in random order and completed the study protocol.
544096|NCT00166166|B3|Baseline|Total|Total of all reporting groups
544097|NCT00166166|B2|Baseline|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544098|NCT00166166|B1|Baseline|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544099|NCT00166166|P2|Participant Flow|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544100|NCT00166166|P1|Participant Flow|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544101|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin, fluconazole and tetraethylammonium (TEA)
544102|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and fluconazole
544103|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin and Tetraethylammonium (TEA)
544104|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of bradykinin
544105|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
544106|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of sodium nitroprusside
544809|NCT00162136|B4|Baseline|35 mg/m2|Ixabepilone
544107|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of fluconazole and Tetraethylammonium (TEA)
544108|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA) and fluconazole
544109|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of L-NG-monomethyl Arginine (L-NMMA), and fluconazole
544110|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole
544111|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and fluconazole.
544112|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
544113|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
544114|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
544115|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and L-NG-monomethyl Arginine (L-NMMA)
544116|NCT00166166|O2|Outcome|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA)
544117|NCT00166166|O1|Outcome|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline (baseline) and Tetraethylammonium (TEA).
544118|NCT00166166|E2|Reported Event|Risk Factors|Non-hypertensive subjects with cardiovascular risk factors had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544119|NCT00166166|E1|Reported Event|Healthy Controls|Healthy subjects had venous occlusion plethysmography after intra-arterial infusions of saline, L-NG-monomethyl Arginine (L-NMMA), Tetraethylammonium (TEA), fluconazole, bradykinin, sodium nitroprusside and acetylcholine
544120|NCT00166114|B3|Baseline|Total|Total of all reporting groups
544121|NCT00166114|B2|Baseline|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
544122|NCT00166114|B1|Baseline|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 until day 56
544123|NCT00166114|P2|Participant Flow|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
544124|NCT00166114|P1|Participant Flow|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
544125|NCT00166114|O2|Outcome|Desipramine|Subjects received 25 mg of desipramine for day 1-3, 50 mg of desipramine for day 4-7, 75 mg of desipramine for day 8-14, 100 mg of desipramine for day 15-21. Subjects titrated between 125 mg to 200 mg of desipramine for day 22-56 of intervention
544126|NCT00166114|O1|Outcome|Escitalopram|Subjects received 10 mg of Escitalopram for 22 days and then were titrated up to 20 mg of Escitalopram after day 22 of intervention until day 56
544127|NCT00166114|E2|Reported Event|Desipramine|25 mg of Desipramine for day 1-3, 50 mg of Desipramine for day 4-7, 75 mg of Desipramine for day 8-14, 100 mg of Desipramine for day 15-21. Titrated between 125 mg to 200 mg of Desipramine for day 22-56 of intervention
544128|NCT00166114|E1|Reported Event|Escitalopram|10 mg of Escitalopram, and titrated up to 20 mg of Escitalopram after day 22 of intervention
544129|NCT00167544|B3|Baseline|Total|Total of all reporting groups
544130|NCT00167544|B2|Baseline|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544131|NCT00167544|B1|Baseline|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544132|NCT00167544|P2|Participant Flow|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544133|NCT00167544|P1|Participant Flow|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544134|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544135|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544136|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544188|NCT00166036|O1|Outcome|Atorvastatin 10 mg|Atorvastatin 10 mg taken daily
544189|NCT00166036|E2|Reported Event|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
544810|NCT00162136|B3|Baseline|30 mg/m2|Ixabepilone
544137|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544138|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544139|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544140|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544141|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544142|NCT00167544|O2|Outcome|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544143|NCT00167544|O1|Outcome|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544144|NCT00167544|E2|Reported Event|Placebo Arm|Subjects randomized by the investigational drug pharmacist to the placebo arm received an equivalent volume of identical appearing 0.9% sterile saline placebo. The IV route was preferred.
544145|NCT00167544|E1|Reported Event|Hydrocortisone Arm|Subjects randomized by the investigational drug pharmacist to hydrocortisone arm received a 7 day course of intravenous (IV) hydrocortisone sodium succinate (Solu-Cortef) every 12 hours (3 mg/kg per day for first 4 days, 2 mg/kg per day for 2 days and 1 mg/kg per day for 1 day; total of 17 mg/kg over 7 days). The IV route was preferred.
544146|NCT00167245|B3|Baseline|Total|Total of all reporting groups
544147|NCT00167245|B2|Baseline|Group 2|placebo : placebo pills
544148|NCT00167245|B1|Baseline|Group 1|"topiramate~Topiramate : 300mg/day for 13 weeks"
544149|NCT00167245|P2|Participant Flow|Placebo|placebo : placebo pills
544150|NCT00167245|P1|Participant Flow|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
544151|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
544152|NCT00167245|O1|Outcome|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
544153|NCT00167245|O2|Outcome|Placebo|placebo : placebo pills
544154|NCT00167245|O1|Outcome|Topirmate|"topiramate~Topiramate : 300mg/day for 13 weeks"
544155|NCT00167245|E2|Reported Event|Placebo|placebo : placebo pills
544156|NCT00167245|E1|Reported Event|Topiramate|"topiramate~Topiramate : 300mg/day for 13 weeks"
544157|NCT00167206|B1|Baseline|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544158|NCT00167206|P1|Participant Flow|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544159|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544160|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544161|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544162|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544163|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544164|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544165|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544166|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544167|NCT00167206|O1|Outcome|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544168|NCT00167206|E1|Reported Event|Intent-To-Treat|All patients with Fanconi anemia who received thymic shielding during total body irradiation (450 cGy).
544169|NCT00167102|B3|Baseline|Total|Total of all reporting groups
544170|NCT00167102|B2|Baseline|Placebo|
544171|NCT00167102|B1|Baseline|Alefacept|
544172|NCT00167102|P2|Participant Flow|Placebo|
544173|NCT00167102|P1|Participant Flow|Alefacept|
544174|NCT00167102|O2|Outcome|Placebo|
544175|NCT00167102|O1|Outcome|Alefacept|
544176|NCT00167102|O2|Outcome|Placebo|Weekly intramuscular administration of placebo 15 mg for 12 weeks
544177|NCT00167102|O1|Outcome|Alefacept|Weekly intramuscular administration of alefacept 15mg for 12 weeks
544178|NCT00167102|E2|Reported Event|Placebo|
544179|NCT00167102|E1|Reported Event|Alefacept|
544180|NCT00166036|B3|Baseline|Total|Total of all reporting groups
544181|NCT00166036|B2|Baseline|Pravastatin 80 mg|Subject treated with oral Pravastatin 80 mg for 12 Weeks.
544182|NCT00166036|B1|Baseline|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
544183|NCT00166036|P2|Participant Flow|Pravastatin 80 mg|Once Daily for 12 Weeks
544184|NCT00166036|P1|Participant Flow|Atorvastatin 10 mg|Once Daily for 12 Weeks
544185|NCT00166036|O2|Outcome|Pravastatin 80 mg|Pravastatin 80 mg daily
544190|NCT00166036|E1|Reported Event|Atorvastatin 10 mg|Subject treated with oral Atorvastatin 10 mg for 12 Weeks.
544191|NCT00165984|B1|Baseline|Single Ventricle Patients|Patients born with single ventricle heart disease
544192|NCT00165984|P1|Participant Flow|Single Ventricle Patients|Patients born with single ventricle heart disease
544193|NCT00165984|O3|Outcome|Heterozygotes|Transplant-free survival for patients heterozygous (G/T) at nucleotide 5665 at 7 years.
544194|NCT00165984|O2|Outcome|Homozygous for Wild-type ppET1 5665|Transplant-free survival for patients homozygous for G at nucleotide 5665 at 7 years.
544195|NCT00165984|O1|Outcome|Preproendothelin-1 (ppET1) 5665 Polymorphism Homozygotes|Transplant-free survival for patients homozygous for T at nucleotide 5665 at 7 years.
544196|NCT00165984|O1|Outcome|Incidence of Preproendothelin-1 5665 Polymorphism|Incidence of Homozygosity for mutation at nucleotide 5665
544197|NCT00165984|E1|Reported Event|Single Ventricle Patients|Patients born with single ventricle heart disease
544198|NCT00165958|B3|Baseline|Total|Total of all reporting groups
544199|NCT00165958|B2|Baseline|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
544200|NCT00165958|B1|Baseline|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
544201|NCT00165958|P2|Participant Flow|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
544202|NCT00165958|P1|Participant Flow|Punch Excision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
544203|NCT00165958|O2|Outcome|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
544204|NCT00165958|O1|Outcome|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
544205|NCT00165958|E2|Reported Event|Traditional Excision|Excisional surgery of epidermal cyst : Traditional extirpation of cyst en toto
544206|NCT00165958|E1|Reported Event|Punch Incision|Punch incision of epidermal cyst : removal of cyst first with incisional effort with a punch biopsy tool
544207|NCT00165841|B3|Baseline|Total|Total of all reporting groups
544208|NCT00165841|B2|Baseline|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
544209|NCT00165841|B1|Baseline|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
544210|NCT00165841|P2|Participant Flow|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
544211|NCT00165841|P1|Participant Flow|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
544212|NCT00165841|O2|Outcome|Placebo|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
544213|NCT00165841|O1|Outcome|Rabeprazole 20 mg|Orally, once daily for 7 to 14-day courses intermittently during the 6-month Maintenance Treatment Phase (ITT population).
544214|NCT00165841|E2|Reported Event|Placebo|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
544215|NCT00165841|E1|Reported Event|Rabeprazole 20 mg|Orally, once daily for 7- to 14-day courses intermittently during the 6-month Double-blind Maintenance Treatment Phase.
544216|NCT00166712|B3|Baseline|Total|Total of all reporting groups
544217|NCT00166712|B2|Baseline|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544218|NCT00166712|B1|Baseline|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC (Prograf) started on the 1st day after surgery, and then taken by mouth twice daily.
544219|NCT00166712|P2|Participant Flow|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544220|NCT00166712|P1|Participant Flow|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
544221|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544253|NCT00166504|E1|Reported Event|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
544254|NCT00166361|B3|Baseline|Total|Total of all reporting groups
544255|NCT00166361|B2|Baseline|JJ Stent|Subjects assigned to this arm received a JJ stent.
544256|NCT00166361|B1|Baseline|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
544222|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
544223|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544224|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
544225|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
544226|NCT00166712|O1|Outcome|Group 1|Evaluated for rejection of their transplanted kidney with a biopsy.
544227|NCT00166712|O2|Outcome|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544228|NCT00166712|O1|Outcome|Group 1: Alemtuzumab + TAC (Prograf) + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
544229|NCT00166712|O2|Outcome|Group 2|Evaluated for rejection of their transplanted kidney with a biopsy.
544230|NCT00166712|O1|Outcome|Groups|Evaluated for rejection of their transplanted kidney with a biopsy.
544231|NCT00166712|E3|Reported Event|Group 1: Post-conversion to Sirolimus|After conversion to Sirolimus, if no rejection of transplanted kidney within 9 months post-transplant, will be weaned off Sirolimus.
544232|NCT00166712|E2|Reported Event|Group 2: Alemtuzumab + Sirolimus + MMF|"Sirolimus will be taken by mouth before transplant surgery and will continue taking once daily after surgery. Group 2 will also receive 2 doses of Alemtuzumab: one during surgery and the second will be given on the second day after surgery. Mycophenolate mofetil will be give on the day of surgery and twice daily, by mouth, as instructed by the doctor.~If subjects do not experience kidney rejection after 6 months after surgery, they will be weaned off of the sirolimus and continue taking the mycophenolate mofetil."
544233|NCT00166712|E1|Reported Event|Group 1: Alemtuzumab + TAC + MMF|Receive two doses of alemtuzumab (Campath-1H, 30mg) by intravenous (IV) infusion. One dose during kidney transplant surgery and the second dose on day 2 (post-surgery) to achieve peripheral T-cell depletion. IV glucocorticoids will be given prior to Campath administration to limit cytokine release syndrome in association with this monoclonal antibody. MMF on the day of surgery and continue taking it by mouth, twice daily. TAC started on the 1st day after surgery, and then taken by mouth twice daily.
544234|NCT00166517|B3|Baseline|Total|Total of all reporting groups
544235|NCT00166517|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544236|NCT00166517|B1|Baseline|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544237|NCT00166517|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544238|NCT00166517|P1|Participant Flow|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544239|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544240|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544241|NCT00166517|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544242|NCT00166517|O1|Outcome|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544243|NCT00166517|E2|Reported Event|Placebo|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544244|NCT00166517|E1|Reported Event|RotaTeq™|Three oral doses of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination.
544245|NCT00166504|B3|Baseline|Total|Total of all reporting groups
544246|NCT00166504|B2|Baseline|Atorvastatin|Atorvastatin 10 mg
544247|NCT00166504|B1|Baseline|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
544248|NCT00166504|P2|Participant Flow|Atorvastatin|Atorvastatin 10 mg
544249|NCT00166504|P1|Participant Flow|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
544250|NCT00166504|O2|Outcome|Atorvastatin|Atorvastatin 10 mg
544251|NCT00166504|O1|Outcome|Vytorin|Ezetimibe 10 mg/Simvastatin 20 mg
544252|NCT00166504|E2|Reported Event|Atorvastatin|Atorvastatin 10 mg
544257|NCT00166361|P2|Participant Flow|JJ Stent|Subjects assigned to this arm received a JJ stent.
544258|NCT00166361|P1|Participant Flow|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
544259|NCT00166361|O2|Outcome|JJ Stent|Subjects assigned to this arm received a JJ stent.
544260|NCT00166361|O1|Outcome|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
544261|NCT00166361|E2|Reported Event|JJ Stent|Subjects assigned to this arm received a JJ stent.
544262|NCT00166361|E1|Reported Event|Memokath 051 Ureteral Stent|Subjects assigned to this arm received a Memokath 051 Ureteral Stent.
544263|NCT00165789|B5|Baseline|Total|Total of all reporting groups
544264|NCT00165789|B4|Baseline|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544265|NCT00165789|B3|Baseline|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544266|NCT00165789|B2|Baseline|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544267|NCT00165789|B1|Baseline|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544268|NCT00165789|P4|Participant Flow|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544269|NCT00165789|P3|Participant Flow|Cohort 2- Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544270|NCT00165789|P2|Participant Flow|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544271|NCT00165789|P1|Participant Flow|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544272|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544273|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544274|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544275|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544276|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544277|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544278|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544279|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544280|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544281|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544282|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544283|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544284|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544285|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544286|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544287|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544288|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544289|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544290|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544291|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544292|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544293|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544294|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544295|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544296|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544297|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544298|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544409|NCT00165646|E1|Reported Event|Placebo|once daily orally for 4 weeks
544299|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544300|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544301|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544302|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544303|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544304|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544305|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544306|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544307|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544308|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544309|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544310|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544311|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544312|NCT00165789|O4|Outcome|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544313|NCT00165789|O3|Outcome|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544314|NCT00165789|O2|Outcome|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544315|NCT00165789|O1|Outcome|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544316|NCT00165789|E4|Reported Event|Cohort 2 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 2 weeks, followed by 8 mg once daily for 4 weeks.
544317|NCT00165789|E3|Reported Event|Cohort 2 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544318|NCT00165789|E2|Reported Event|Cohort 1 - Perampanel|Perampanel started at 2 mg once daily for 2 weeks, followed by 3 mg once daily for 2 weeks, followed by 4 mg once daily for 2 weeks, followed by 6 mg once daily for 4 weeks.
544319|NCT00165789|E1|Reported Event|Cohort 1 - Placebo|Placebo matching Perampanel dosing once daily for 10 weeks.
544320|NCT00165776|B5|Baseline|Total|Total of all reporting groups
544321|NCT00165776|B4|Baseline|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544322|NCT00165776|B3|Baseline|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose. One subject from the 5,000 U/2 mL did not receive treatment after randomization.
544323|NCT00165776|B2|Baseline|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544324|NCT00165776|B1|Baseline|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose. Two subjects from the placebo group did not receive treatment after randomization.
544325|NCT00165776|P4|Participant Flow|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544326|NCT00165776|P3|Participant Flow|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544327|NCT00165776|P2|Participant Flow|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544328|NCT00165776|P1|Participant Flow|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544329|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544330|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544331|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544332|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544333|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544334|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544335|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544336|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544337|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544338|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544339|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544340|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544341|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544342|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544343|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544344|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544345|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544346|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544347|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544348|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544349|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544350|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544351|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544352|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544353|NCT00165776|O4|Outcome|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544354|NCT00165776|O3|Outcome|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544355|NCT00165776|O2|Outcome|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544356|NCT00165776|O1|Outcome|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544357|NCT00165776|E4|Reported Event|E2014 10,000 U|10,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544358|NCT00165776|E3|Reported Event|E2014 5,000 U|5,000 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544359|NCT00165776|E2|Reported Event|E2014 2,500 U|2,500 U/2 mL was intramuscularly injected to cervical muscles as a single dose
544360|NCT00165776|E1|Reported Event|Placebo|placebo/ 2 mL was intramuscularly injected to cervical muscles as a single dose
544361|NCT00165698|B3|Baseline|Total|Total of all reporting groups
544362|NCT00165698|B2|Baseline|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544363|NCT00165698|B1|Baseline|Menatetrenone|15 mg t.i.d. orally for 12 months
544364|NCT00165698|P2|Participant Flow|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544365|NCT00165698|P1|Participant Flow|Menatetrenone|15 mg t.i.d. orally for 12 months
544366|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544367|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544368|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544369|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544370|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544371|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544372|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544373|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544374|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544375|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544376|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544377|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544378|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544379|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544380|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544381|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544382|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544383|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544384|NCT00165698|O2|Outcome|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544385|NCT00165698|O1|Outcome|Menatetrenone|15 mg t.i.d. orally for 12 months
544386|NCT00165698|E2|Reported Event|Alfacalcidol|0.25 μg b.i.d. orally for 12 months
544387|NCT00165698|E1|Reported Event|Menatetrenone|15 mg t.i.d. orally for 12 months
544388|NCT00165672|B3|Baseline|Total|Total of all reporting groups
544389|NCT00165672|B2|Baseline|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
544390|NCT00165672|B1|Baseline|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
544391|NCT00165672|P2|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
544392|NCT00165672|P1|Participant Flow|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
544393|NCT00165672|O2|Outcome|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
544394|NCT00165672|O1|Outcome|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
544395|NCT00165672|E2|Reported Event|E3810 Pariet (Rabeprazole Sodium) 10 mg|E3810 10 mg: once daily orally for 4 weeks
544396|NCT00165672|E1|Reported Event|E3810 Pariet (Rabeprazole Sodium) 5 mg|E3810 5 mg: once daily orally for 4 weeks
544397|NCT00165646|B4|Baseline|Total|Total of all reporting groups
544398|NCT00165646|B3|Baseline|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
544399|NCT00165646|B2|Baseline|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
544400|NCT00165646|B1|Baseline|Placebo|once daily orally for 4 weeks
544401|NCT00165646|P3|Participant Flow|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
544402|NCT00165646|P2|Participant Flow|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
544403|NCT00165646|P1|Participant Flow|Placebo|once daily orally for 4 weeks
544404|NCT00165646|O3|Outcome|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
544405|NCT00165646|O2|Outcome|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
544406|NCT00165646|O1|Outcome|Placebo|once daily orally for 4 weeks
544407|NCT00165646|E3|Reported Event|E3810 10 mg|E3810 (Pariet (Rabeprazole Sodium))10 mg once daily orally for 4 weeks
544408|NCT00165646|E2|Reported Event|E3810 5 mg|E3810 (Pariet (Rabeprazole Sodium)) 5 mg once daily orally for 4 weeks
544410|NCT00165503|B1|Baseline|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
544411|NCT00165503|P1|Participant Flow|Cisplatin, Sodium Thiosulfate, Alimta|Heated Cisplatin will be given as a one-hour lavage of the chest and abdominal cavity following surgery.Cisplatin will also be administered intravenously as part of chemotherapy 6-10 weeks after surgery. It will be given on day 1 of each 21-day treatment cycle for 3 cycles. Sodium Thiosulfate Given intravenously over 6 hours following heated cisplatin lavage. Alimta Given intravenously on day 1 of each 21-day treatment cycle for a total of 3 cycles beginning 6-10 weeks after surgery.
544412|NCT00165503|O1|Outcome|Surgery+Heated Cisplatin+Sodium Thiosulfate+Adjuvant CT|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours. The adjuvant chemotherapy regimen beginning 6-10 weeks after surgery is a combination of cisplatin and Alimta each given day 1 of a 21-day cycle for 3 cycles.
544413|NCT00165503|E1|Reported Event|Surgery + Heated Cisplatin Lavage + Sodium Thiosulfate|Participants undergo surgery, Pleurectomy/Decortication, followed by heated cisplatin given as a one-hour lavage of the chest and abdominal cavity then sodium thiosulfate given intravenously over 6 hours.
544414|NCT00163293|B4|Baseline|Total|Total of all reporting groups
544415|NCT00163293|B3|Baseline|Placebo|
544416|NCT00163293|B2|Baseline|CIC 200|Ciclesonide 200µg
544417|NCT00163293|B1|Baseline|CIC 100|Ciclesonide 100µg
544418|NCT00163293|P3|Participant Flow|Placebo|two puffs once daily, in the evening
544419|NCT00163293|P2|Participant Flow|CIC 200|Ciclesonide 200µg, two puffs once daily, in the evening
544420|NCT00163293|P1|Participant Flow|CIC 100|Ciclesonide 100µg, two puffs once daily, in the evening
544421|NCT00163293|O3|Outcome|Placebo|
544422|NCT00163293|O2|Outcome|CIC 200|Ciclesonide 200µg
544423|NCT00163293|O1|Outcome|CIC 100|Ciclesonide 100µg
544424|NCT00163293|O3|Outcome|Placebo|
544425|NCT00163293|O2|Outcome|CIC 200|Ciclesonide 200µg
544426|NCT00163293|O1|Outcome|CIC 100|Ciclesonide 100µg
544427|NCT00163293|O3|Outcome|Placebo|
544428|NCT00163293|O2|Outcome|CIC 200|Ciclesonide 200µg
544429|NCT00163293|O1|Outcome|CIC 100|Ciclesonide 100µg
544430|NCT00163293|E3|Reported Event|Placebo|two puffs once daily, in the evening
544431|NCT00163293|E2|Reported Event|CIC 200|Ciclesonide 200µg, two puffs once daily, in the evening
544432|NCT00163293|E1|Reported Event|CIC 100|Ciclesonide 100µg, two puffs once daily, in the evening
544433|NCT00163657|B4|Baseline|Total|Total of all reporting groups
544434|NCT00163657|B3|Baseline|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
544435|NCT00163657|B2|Baseline|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
544436|NCT00163657|B1|Baseline|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
544437|NCT00163657|P3|Participant Flow|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
544438|NCT00163657|P2|Participant Flow|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
544439|NCT00163657|P1|Participant Flow|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
544440|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
544441|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
544442|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
544443|NCT00163657|O3|Outcome|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
544444|NCT00163657|O2|Outcome|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
544445|NCT00163657|O1|Outcome|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
544446|NCT00163657|E3|Reported Event|Treatment Arm 3|Immunosuppression DAC (daclizumub), MMF (mofetil mycophenolate)and TAC (tacrolimus)
544447|NCT00163657|E2|Reported Event|Treatment Arm 2|Immunosuppression MMF(mofetil mycophenolate), TAC (tacrolimus) and CS (cyclosporine)
544448|NCT00163657|E1|Reported Event|Treatment Arm 1|Immunosuppression TAC (tacrolimus) and CS (cyclosporine)
544449|NCT00163215|B1|Baseline|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544450|NCT00163215|P1|Participant Flow|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544451|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544452|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544453|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544454|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544455|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544598|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544456|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544457|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544458|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544459|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544460|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544461|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544462|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544463|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544464|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544465|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544466|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544467|NCT00163215|O1|Outcome|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544468|NCT00163215|E1|Reported Event|Genotonorm|Genotonorm (recombinant somatropin) up to maximum of 50 microgram/kilogram/day (mcg/kg/day) subcutaneously as decided by the investigator, divided in 7 daily doses for up to 3 years.
544469|NCT00163189|B1|Baseline|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544470|NCT00163189|P1|Participant Flow|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544471|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544472|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544473|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544474|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544475|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544476|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544477|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544478|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544479|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544480|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544481|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544482|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544483|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544484|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544485|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544486|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544487|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544488|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544489|NCT00163189|O1|Outcome|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544490|NCT00163189|E1|Reported Event|Genotonorm|Genotonorm 0.46 milligram per kilogram (mg/kg) administered weekly, divided into 7 daily subcutaneous injections (maximum dose not exceeding 50 microgram [mcg]/kg/day) for up to 60 months.
544491|NCT00163020|B3|Baseline|Total|Total of all reporting groups
544492|NCT00163020|B2|Baseline|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
544493|NCT00163020|B1|Baseline|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
544494|NCT00163020|P2|Participant Flow|2 - Control (Castor Oil)|Control Group will receive a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
544495|NCT00163020|P1|Participant Flow|1 Test Group (170HP)|Test Group will receive a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever comes first.
544496|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544497|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544498|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544499|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544500|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544501|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544502|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544503|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544504|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544505|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544506|NCT00163020|O2|Outcome|Triplet Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Triplet Pregnancies
544507|NCT00163020|O1|Outcome|Triplet Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Triplet Pregnancies
544508|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544509|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544510|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544511|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544512|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544513|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544514|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544515|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544516|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544517|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544518|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544519|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544520|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544521|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544522|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544523|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544524|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544525|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544526|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544527|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544528|NCT00163020|O2|Outcome|Twins Group - Placebo Arm|Weekly injection of Placebo medication (castor oil)to patients with Twin Pregnancies
544529|NCT00163020|O1|Outcome|Twins Group = Test Arm - 17OHP|Weekly injection of 170HP (250mg)to patients with Twin Pregnancies
544530|NCT00163020|E2|Reported Event|Control (Castor Oil)|Both Twins and Triplets in the Control Group received a weekly dose of placebo (castor oil) via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
544599|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544531|NCT00163020|E1|Reported Event|Test Group (170HP)|Both Twins and Triplets in the Test Group received a weekly dose of 170HP via injection as early as 19weeks until 34weeks 0days gestation or delivery which ever came first.
544532|NCT00162981|B3|Baseline|Total|Total of all reporting groups
544533|NCT00162981|B2|Baseline|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544534|NCT00162981|B1|Baseline|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544535|NCT00162981|P2|Participant Flow|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544536|NCT00162981|P1|Participant Flow|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544537|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544538|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544539|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544540|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544541|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544542|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544543|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544544|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544545|NCT00162981|O2|Outcome|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544546|NCT00162981|O1|Outcome|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544547|NCT00162981|E2|Reported Event|Clobazam High Dose|5 to 40 mg/day with doses in the morning and at bedtime; orally
544548|NCT00162981|E1|Reported Event|Clobazam Low Dose|5 to 10 mg/day with doses in the morning and at bedtime; orally
544549|NCT00162942|B3|Baseline|Total|Total of all reporting groups
544550|NCT00162942|B2|Baseline|Sham|Sham, ten apheresis sessions within 9 weeks
544551|NCT00162942|B1|Baseline|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544552|NCT00162942|P2|Participant Flow|Sham|Sham, ten apheresis sessions within 9 weeks
544553|NCT00162942|P1|Participant Flow|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544554|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544555|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544556|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544557|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544558|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544559|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544560|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544561|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544562|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544563|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544564|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544565|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544566|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544567|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544568|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544569|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544570|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544571|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544572|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544573|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544574|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544575|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544576|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544577|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544578|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544579|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544580|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544581|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544582|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544583|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544584|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544585|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544586|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544587|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544588|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544589|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544590|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544591|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544592|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544593|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544594|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544595|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544596|NCT00162942|O2|Outcome|Sham|Sham, ten apheresis sessions within 9 weeks
544597|NCT00162942|O1|Outcome|Adacolumn|Adacolumn, ten apheresis sessions within 9 weeks
544600|NCT00162370|B1|Baseline|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
544601|NCT00162370|P1|Participant Flow|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
544602|NCT00162370|O1|Outcome|Definity|"All patients will undergo a gray scale baseline unenhanced imaging session (apical 2- or 4 chamber view), as well as a DEFINITY (Perflutren Lipid Microsphere Injectable Suspension)-enhanced rest and a DEFINITY enhanced exercise or dobutamine stress echocardiography imaging session. The unenhanced and DEFINITY-enhanced rest and stress echocardiography imaging sessions will be performed on the same day. For the DEFINITY-enhanced imaging sessions all patients will receive diluted DEFINITY intravenously (IV). Diluted DEFINITY will be prepared by mixing 1 mL of activated DEFINITY® with 9 mL of normal saline in a 10 mL syringe.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
544603|NCT00162370|O1|Outcome|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
544604|NCT00162370|E1|Reported Event|Definity|"Open-lable, non-randomized, Phase IV trial with Definity to determine the prognostic value of stress echocardiogrophy as a screening exam in peri-, post-menopausal females with an intermediate likelihood of coronary artery disease to identify patients at higher risk of experiencing future cardiac events.~Perflutren Lipid Microsphere Injectable Suspension: Activated DEFINITY 10ug/kg by bolus injection"
544605|NCT00162266|B4|Baseline|Total|Total of all reporting groups
544606|NCT00162266|B3|Baseline|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544607|NCT00162266|B2|Baseline|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544608|NCT00162266|B1|Baseline|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544609|NCT00162266|P4|Participant Flow|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544610|NCT00162266|P3|Participant Flow|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544611|NCT00162266|P2|Participant Flow|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544612|NCT00162266|P1|Participant Flow|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544613|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544614|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544656|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544811|NCT00162136|B2|Baseline|20 mg/m2|Ixabepilone
544615|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544616|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544617|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544618|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544619|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544620|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DBperiod received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately weight-tiered dose of abatacept 10 mg/kg.
544621|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544622|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544623|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544624|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544625|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544626|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544627|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544628|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544629|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544630|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544631|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544632|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544633|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg /kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544634|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544635|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544636|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by an IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544637|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544638|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544639|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544640|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544641|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544642|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544643|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544644|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544645|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544646|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544647|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544648|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544649|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544650|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544651|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544652|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544653|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544654|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544655|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544812|NCT00162136|B1|Baseline|10 mg/m2|Ixabepilone
544657|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544658|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544659|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544660|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544661|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544662|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544663|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544664|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the double-blind period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544665|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544666|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544667|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544668|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544669|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544670|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544671|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544672|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544673|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544674|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544675|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544676|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544677|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544678|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544679|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544680|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544681|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544682|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by I) infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
544683|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544684|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg /kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg abatacept administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544685|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544686|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g.
544687|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544688|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544689|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544690|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544691|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by intravenous IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544692|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544693|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544694|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544695|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544696|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544697|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544698|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an on OL weight-tiered dose of abatacept 10 mg/kg.
544699|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544700|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544701|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544702|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544703|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544704|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544705|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544706|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the DBperiod received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing <60 kg received abatacept 500 mg, participants weighing ≥60 kg and ≤100 kg received abatacept 750 mg, and participants >100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544707|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544708|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544709|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg/kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544710|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544711|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544712|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544713|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544714|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544813|NCT00162136|P1|Participant Flow|Ixabepilone|Intravenous (IV) Infusion; 10, 20, 30, 35, 40 & 45 mg/m2, once every 21 days (1 cycle), up to 9 cycles
544814|NCT00162136|O1|Outcome|All Treated Participants|
544715|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544716|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544717|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544718|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544719|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544720|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544721|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544722|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544723|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544724|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544725|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544726|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544727|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544759|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544728|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544729|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544730|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544731|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544732|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544733|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the DB period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544734|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544735|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544736|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544737|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the DB period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544738|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the DB period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an OL weight-tiered dose of abatacept 10 mg/kg.
544739|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544740|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544741|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544742|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544743|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544815|NCT00162136|O1|Outcome|Treated Subjects|All treated subjects with measurement at timepoint
544816|NCT00162136|O5|Outcome|Grade 4|Life-threatening or disabling
544744|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544745|NCT00162266|O4|Outcome|Open-Label (OL) Abatacept (10 mg / kg)|Following a 5-month interim (where the placebo group was split into 2mg/kg abatacept or placebo and participants in 2 original abatacept continued at same dose), participants who enrolled in OL period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544746|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544747|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544748|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544749|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544750|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544751|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544752|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544753|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544754|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544755|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544756|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544757|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544758|NCT00162266|O1|Outcome|OL Abatacept (10 mg / kg)|OL participants received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g.
544760|NCT00162266|O3|Outcome|OL Abatacept: Original Placebo Group|Participants in the double-blind period received a placebo that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544761|NCT00162266|O2|Outcome|OL Abatacept: Original 2 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544762|NCT00162266|O1|Outcome|OL Abatacept: Original 10 mg / kg Group|Participants in the double-blind period received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by IV infusion over approximately 30 minutes. Participants weighing < 60 kg received abatacept 500 mg, participants weighing ≥ 60 kg and ≤ 100 kg received abatacept 750 mg, and participants > 100 kg received abatacept 1 g. Participants in the present study received an open-label weight-tiered dose of abatacept 10 mg/kg.
544763|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544764|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544765|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544766|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544767|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544768|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544769|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544770|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544771|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544772|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544773|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544774|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544802|NCT00162266|E4|Reported Event|Placebo+MTX|
544775|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544776|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544777|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544778|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544779|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544780|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544781|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544782|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544783|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544784|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544785|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544786|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544787|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544803|NCT00162266|E3|Reported Event|Abatacept (LT)|
544804|NCT00162266|E2|Reported Event|Aba 2mg/kg+MTX|
544805|NCT00162266|E1|Reported Event|Aba 10mg/kg+MTX|
544806|NCT00162136|B7|Baseline|Total|Total of all reporting groups
544807|NCT00162136|B6|Baseline|45 mg/m2|Ixabepilone
544808|NCT00162136|B5|Baseline|40 mg/m2|Ixabepilone
544788|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544789|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544790|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544791|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544792|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544793|NCT00162266|O3|Outcome|Double-Blind (DB) Placebo + Methotrexate|Participants in the DB study received a placebo that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544794|NCT00162266|O2|Outcome|Double-Blind (DB) Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544795|NCT00162266|O1|Outcome|Double-Blind (DB) Abatacept 10 mg/kg + Methotrexate (MTX)|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept that was administered monthly by an intravenous (IV) plus methotrexate (MTX).Participants were maintained on a stable dose of MTX (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and MTX (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544796|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544797|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered monthly IV plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544798|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 10 mg/kg of abatacept administered monthly IV plus methotrexateParticipants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544799|NCT00162266|O3|Outcome|DB Placebo + Methotrexate|Participants in the DB study received a placebo that was administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate(maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
544800|NCT00162266|O2|Outcome|DB Abatacept 2 mg/kg + Methotrexate|Participants in the DB study received a weight-tiered dose of 2 mg/kg of abatacept administered IV monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate (10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold, or azathioprine) during Days 181 to 360 of the DB period.
544801|NCT00162266|O1|Outcome|DB Abatacept 10 mg/kg + Methotrexate|Participants received a weight-tiered dose of 10 mg/kg of abatacept, administered intravenously(IV) monthly plus methotrexate. Participants were maintained on a stable dose of methotrexate(10-30 mg/wk) during Days 1 to 180 of the DB period; adjustments in corticosteroids (maximum 10 mg/day) and methotrexate (maximum 30 mg/wk) were permitted (as well as addition of either hydroxychloroquine, sulfasalazine, gold or azathioprine) during Days 181 to 360 of the DB period.
544817|NCT00162136|O4|Outcome|Grade 3|Severe
544818|NCT00162136|O3|Outcome|Grade 2|Moderate
544819|NCT00162136|O2|Outcome|Grade 1|Mild
544820|NCT00162136|O1|Outcome|Grade 0|Absent
544821|NCT00162136|O3|Outcome|All Grades|Grades 1-4
544822|NCT00162136|O2|Outcome|Grade 3/4|Grade 3=Severe, Grade 4=Life-threatening or disabling
544823|NCT00162136|O1|Outcome|Grade 1/2|Grade 1=Mild, Grade 2=Moderate
544824|NCT00162136|O6|Outcome|45 mg/m2|Ixabepilone
544825|NCT00162136|O5|Outcome|40 mg/m2|Ixabepilone
544826|NCT00162136|O4|Outcome|35 mg/m2|Ixabepilone
544827|NCT00162136|O3|Outcome|30 mg/m2|Ixabepilone
544828|NCT00162136|O2|Outcome|20 mg/m2|Ixabepilone
544829|NCT00162136|O1|Outcome|10 mg/m2|Ixabepilone
544830|NCT00162136|E6|Reported Event|Ixa 45 mg/m2|
544831|NCT00162136|E5|Reported Event|Ixa 40 mg/m2|
544832|NCT00162136|E4|Reported Event|Ixa 35 mg/m2|
544833|NCT00162136|E3|Reported Event|Ixa 30 mg/m2|
544834|NCT00162136|E2|Reported Event|Ixa 20 mg/m2|
544835|NCT00162136|E1|Reported Event|Ixa 10 mg/m2|
544836|NCT00162123|B9|Baseline|Total|Total of all reporting groups
544837|NCT00162123|B8|Baseline|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
544838|NCT00162123|B7|Baseline|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544839|NCT00162123|B6|Baseline|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544840|NCT00162123|B5|Baseline|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544841|NCT00162123|B4|Baseline|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
544842|NCT00162123|B3|Baseline|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544843|NCT00162123|B2|Baseline|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544844|NCT00162123|B1|Baseline|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544845|NCT00162123|P8|Participant Flow|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
544846|NCT00162123|P7|Participant Flow|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544847|NCT00162123|P6|Participant Flow|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544848|NCT00162123|P5|Participant Flow|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544849|NCT00162123|P4|Participant Flow|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
544850|NCT00162123|P3|Participant Flow|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544950|NCT00162032|P2|Participant Flow|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
544951|NCT00162032|P1|Participant Flow|Children (Ages 4-11)|Arm A children 4-11 years of age
544952|NCT00162032|O4|Outcome|Adolescents (12-16 Years) Abnormal|sss (summed stress score >4, high risk
544953|NCT00162032|O3|Outcome|Children (4-11 Years) Abnormal|SSS (summed stress score)>4, high risk
544851|NCT00162123|P2|Participant Flow|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544852|NCT00162123|P1|Participant Flow|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544853|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544854|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544855|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544856|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544857|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544858|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544859|NCT00162123|O7|Outcome|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
544860|NCT00162123|O6|Outcome|Extended Maintenance: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544861|NCT00162123|O5|Outcome|Extended Maintenance: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544862|NCT00162123|O4|Outcome|Extended Maintenance: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544863|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 0.3 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544864|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544865|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
545583|NCT00158600|B3|Baseline|Total|Total of all reporting groups
544866|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544867|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544868|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544869|NCT00162123|O3|Outcome|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544870|NCT00162123|O2|Outcome|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544871|NCT00162123|O1|Outcome|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544872|NCT00162123|E8|Reported Event|Follow-up|Participants did not receive any additional study treatment in current study but continued follow-up for the collection of survival data.
544873|NCT00162123|E7|Reported Event|Extended Maintenance Only: Ipilimumab, 0.3 mg/kg|Participants who received ipilimumab, 0.3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (0.3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544874|NCT00162123|E6|Reported Event|Extended Maintenance Only: Ipilimumab, 3 mg/kg|Participants who received ipilimumab, 3 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (3 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544875|NCT00162123|E5|Reported Event|Extended Maintenance Only: Ipilimumab, 10 mg/kg|Participants who received ipilimumab, 10 mg/kg, in a parent study and who achieved extended clinical benefit received the same dose of ipilimumab (10 mg/kg) as maintenance in the current study. Maintenance dosing was administered every 12 weeks until disease progression, unacceptable toxicity, or withdrawal of consent.
544876|NCT00162123|E4|Reported Event|First Reinduction: Ipilimumab, Other Dosage|Participants who received a dose other than 10, 3, or 0.3 mg/kg ipilimumab in parent study received a first reinduction of either 3 or 10 mg/kg in current study.
544877|NCT00162123|E3|Reported Event|First Reinduction: Ipilimumab, 0.3 to 10 mg/kg|Participants who initially received ipilimumab, 0.3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544878|NCT00162123|E2|Reported Event|First Reinduction: Ipilimumab, 3 to 10 mg/kg|Participants who initially received ipilimumab, 3 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544879|NCT00162123|E1|Reported Event|First Reinduction: Ipilimumab, 10 to 10 mg/kg|Participants who initially received ipilimumab, 10 mg/kg, in a parent study received ipilimumab, 10 mg/kg in the current study. Ipilimumab was administered as an individual open-label dose every 3 weeks for the first 10 weeks of reinduction for a total of 4 separate doses unless the patient experienced disease progression or withdrew consent. Participants had to wait 3 weeks from the last dose of ipilimumab in a parent study to the first dose of ipilimumab in the current study.
544880|NCT00162097|B5|Baseline|Total|Total of all reporting groups
544881|NCT00162097|B4|Baseline|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544954|NCT00162032|O2|Outcome|Adolescents (12-16 Years) Normal|SSS (summed stress score) <4, low risk
544955|NCT00162032|O1|Outcome|Children (4 -11 Years) Normal|SSS (summed stress score) <=4, low risk
544882|NCT00162097|B3|Baseline|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544883|NCT00162097|B2|Baseline|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544884|NCT00162097|B1|Baseline|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544885|NCT00162097|P4|Participant Flow|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544886|NCT00162097|P3|Participant Flow|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544887|NCT00162097|P2|Participant Flow|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544888|NCT00162097|P1|Participant Flow|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544889|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544890|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544891|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544892|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544893|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544956|NCT00162032|E2|Reported Event|Adolescents (Ages 12-16)|Arm B adolescents 12-16 years of age
544957|NCT00162032|E1|Reported Event|Children (Ages 4-11)|Arm A children 4-11 years of age
544958|NCT00161616|B3|Baseline|Total|Total of all reporting groups
544959|NCT00161616|B2|Baseline|Standard of Care|Standard of Care: Surgical fixation only
544894|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544895|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544896|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544897|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544898|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544899|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544900|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544901|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544902|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544903|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544904|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544905|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544960|NCT00161616|B1|Baseline|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
544961|NCT00161616|P2|Participant Flow|Standard of Care|Standard of Care: Surgical fixation only
544906|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544907|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544908|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544909|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544910|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544911|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544912|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544913|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544914|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544915|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544916|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544917|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544962|NCT00161616|P1|Participant Flow|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
544963|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
544918|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544919|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544920|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544921|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544922|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544923|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544924|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544925|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544926|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544927|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544928|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544929|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544964|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
544965|NCT00161616|O2|Outcome|Standard of Care|Standard of Care: Surgical fixation only
544930|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544931|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544932|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544933|NCT00162097|O5|Outcome|Participants Not Dosed|Participants were enrolled in the study and discontinued prior to study drug administration
544934|NCT00162097|O4|Outcome|Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544935|NCT00162097|O3|Outcome|Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544936|NCT00162097|O2|Outcome|Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544937|NCT00162097|O1|Outcome|Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544938|NCT00162097|O4|Outcome|EFV600mg Participants With Normal Hepatic Function|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM) on an empty stomach. The duration of efavirenz administration was 2 days when participants were admitted to the clinical facility. Participants were enrolled after at least 6 participants with hepatic impairment had completed. One participant enrolled twice in the study and is hence counted twice in this group
544939|NCT00162097|O3|Outcome|EFV600mg Participants With Severe Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Participants who were on an off-label reduced dose of efavirenz (eg, 400 mg) continued on the reduced dose. Severe hepatic impairment (grade C) is defined as a CP total score of 10-15.
544940|NCT00162097|O2|Outcome|EFV600mg Participants With Moderate Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Moderate hepatic impairment (grade B) is defined as a CP total score of 7-9.
544941|NCT00162097|O1|Outcome|EFV600mg Participants With Mild Hepatic Impairment|Participants were administered a dose of 600 mg once daily (capsules or tablets) of efavirenz, either in the morning (at approximately 9:00 AM) or before bed time (at approximately 9:00 PM), on an empty stomach. The duration of efavirenz administration was 2 days and participants were admitted to the clinical facility for this period. Mild hepatic impairment (grade A) is defined as a Child-Pugh (CP) total score of 5-6. The CP classification assesses 5 hepatic parameters (total serum bilirubin, serum albumin, prothrombin time, ascites and encephalopathy) on a scale of 1 (mild or none) to 3 (most severe). Total score range is 5 (mild) to 15 (severe).
544942|NCT00162097|E5|Reported Event|Not Dosed|
544943|NCT00162097|E4|Reported Event|EFV600mg Participants With Normal Hepatic Function|
544944|NCT00162097|E3|Reported Event|EFV600mg Participants With Severe Hepatic Impairment|
544945|NCT00162097|E2|Reported Event|EFV600mg Participants With Moderate Hepatic Impairment|
544946|NCT00162097|E1|Reported Event|EFV600mg Participants With Mild Hepatic Impairment|
544947|NCT00162032|B3|Baseline|Total|Total of all reporting groups
544948|NCT00162032|B2|Baseline|Adolescents (Ages 12-16)|Arm B children 12-16 years of age
544949|NCT00162032|B1|Baseline|Children (Ages 4-11)|Arm A children 4-11 years of age
546716|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
544966|NCT00161616|O1|Outcome|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
544967|NCT00161616|E2|Reported Event|Standard of Care|Standard of Care: Surgical fixation only
544968|NCT00161616|E1|Reported Event|rhBMP-2/ACS|InductOs (dibotermin alfa) contains 12 mg of recombinant human bone morphogenetic protein-2 (rhBMP-2) in the form of a 1.5 mg/ml solution on an absorbable collagen sponge (ACS) implanted once at the time of definitive fracture coverage + surgical fixation
544969|NCT00161473|B3|Baseline|Total|Total of all reporting groups
544970|NCT00161473|B2|Baseline|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544971|NCT00161473|B1|Baseline|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544972|NCT00161473|P2|Participant Flow|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544973|NCT00161473|P1|Participant Flow|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544974|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544975|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544976|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544977|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544978|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544979|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544980|NCT00161473|O2|Outcome|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544981|NCT00161473|O1|Outcome|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544982|NCT00161473|E2|Reported Event|Placebo|Placebo is an inert substance used as a standard comparator in clinical pharmacologic trials.
544983|NCT00161473|E1|Reported Event|Prazosin|Participants taking prazosin. Prazosin was administered as 1 or 2 mg capsules. Doses were initiated at 1 mg at bedtime. Titration based on tolerability was conducted up to a dose of 2 mg in the morning plus 4mg at bedtime.
544984|NCT00161382|B3|Baseline|Total|Total of all reporting groups
544985|NCT00161382|B2|Baseline|Control Group|No intervention: Control curriculum consists of standard sexual education.
544986|NCT00161382|B1|Baseline|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
544987|NCT00161382|P2|Participant Flow|Control Group|No intervention: Control curriculum consists of standard sexual education.
544988|NCT00161382|P1|Participant Flow|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
544989|NCT00161382|O2|Outcome|Control Group|No intervention: Control curriculum consists of standard sexual education.
544990|NCT00161382|O1|Outcome|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
544991|NCT00161382|E2|Reported Event|Control Group|No intervention: Control curriculum consists of standard sexual education.
545012|NCT00160693|B1|Baseline|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545013|NCT00160693|P1|Participant Flow|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545014|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545015|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545016|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
544992|NCT00161382|E1|Reported Event|Intervention Group|"Participants receiving HIV, STD, and pregnancy prevention curriculum~HIV, STD, Pregnancy Prevention Curriculum: This HIV, STD, and pregnancy intervention program entitled, It's Your Game...Keep it Real, consists of 12 lessons delivered in Grades 7 and 8. In each grade, the program integrates group-based classroom activities (e.g., role plays, group discussion, small group activities) with personalized journaling and individual tailored activities delivered on laptop computers. A life skills decision-making paradigm (Select, Detect, Protect) underlies the activities, teaching students to select personal limits regarding risk behaviors, to detect signs or situations that might challenge these limits, and to use refusal skills and other tactics to protect these limits."
544993|NCT00161213|B1|Baseline|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544994|NCT00161213|P1|Participant Flow|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544995|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544996|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544997|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544998|NCT00161213|O1|Outcome|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
544999|NCT00161213|E1|Reported Event|Gemcitabine and Imatinib|"imatinib mesylate: 400 mg/day, given orally Day 1-5 and 8-12 every 21 days.~gemcitabine hydrochloride: fixed dose rate infuration at 1200 mg/m2/120 minutes on Days 3 and 10 every 21 days."
545000|NCT00160706|B1|Baseline|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545001|NCT00160706|P1|Participant Flow|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545002|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545003|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545004|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545005|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545006|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545007|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545008|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545009|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545010|NCT00160706|O1|Outcome|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
545011|NCT00160706|E1|Reported Event|Certolizumab Pegol|"3-dose induction regimen of Certolizumab Pegol 400 mg at Weeks 0, 2, 4. Subsequently continue on 4-weekly treatment with Certolizumab Pegol 400 mg until Week 360.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Weeks 0, 2, 4 and thereafter every 4 weeks until Week 360.~Up to 84 months of therapy in this study."
546717|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
545017|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545018|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545019|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545020|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545021|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545022|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545023|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545024|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545025|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545026|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545027|NCT00160693|O1|Outcome|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545028|NCT00160693|E1|Reported Event|Certolizumab Pegol|400 mg of Certolizumab Pegol subcutaneously every 4 Weeks.
545029|NCT00160641|B1|Baseline|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545030|NCT00160641|P1|Participant Flow|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545031|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545032|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545033|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545034|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545035|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545036|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545037|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545038|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545039|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
546718|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
545040|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545041|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545042|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545043|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545044|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545045|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545046|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545047|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545048|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545049|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545050|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545051|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545052|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545053|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545054|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545055|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545056|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545057|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545058|NCT00160641|O1|Outcome|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545059|NCT00160641|E1|Reported Event|Certolizumab Pegol|"All patients received Certolizumab Pegol (CZP) 400 mg subcutaneously (sc) every two weeks, given as two 1 ml injections of CZP for at least six months and then 200 mg of CZP sc every two weeks, given as one 1 ml injection.~Certolizumab Pegol : Strength and Form: 1 ml of Liquid product containing 200 mg of Certolizumab Pegol (CZP) given as a subcutaneous injection.~Dosage and Frequency: 400 mg every two weeks for at least 6 months, then 200 mg every two weeks.~Duration: Until end of study."
545060|NCT00160563|B4|Baseline|Total|Total of all reporting groups
545061|NCT00160563|B3|Baseline|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
545062|NCT00160563|B2|Baseline|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
545063|NCT00160563|B1|Baseline|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
545064|NCT00160563|P3|Participant Flow|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
545065|NCT00160563|P2|Participant Flow|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
545066|NCT00160563|P1|Participant Flow|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
545067|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
545068|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
545069|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
545070|NCT00160563|O3|Outcome|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
545071|NCT00160563|O2|Outcome|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
545072|NCT00160563|O1|Outcome|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
545073|NCT00160563|E4|Reported Event|PLC-LCTZ|Levocetirizine after having been randomized to Placebo in the preceding A00309 trial (PLC-LCTZ) erroneously (Patient 016/1709)
545074|NCT00160563|E3|Reported Event|PLC-PLC|Placebo after having been randomized to Placebo in the preceding A00309 trial (PLC-PLC)
545075|NCT00160563|E2|Reported Event|LCTZ-PLC|Placebo after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ - PLC)
545076|NCT00160563|E1|Reported Event|LCTZ-LCTZ|Levocetirizine after having been randomized to Levocetirizine in the preceding A00309 trial (LCTZ-LCTZ)
545077|NCT00160524|B1|Baseline|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545078|NCT00160524|P1|Participant Flow|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545079|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545080|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545081|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545159|NCT00160251|O2|Outcome|>4 to 8 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 4 to 8.
545082|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545083|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545084|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545085|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545086|NCT00160524|O1|Outcome|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545087|NCT00160524|E1|Reported Event|Certolizumab Pegol|"400 mg subcutaneous injection every 4 weeks from Week 2 to Week 362.~Certolizumab Pegol (CDP870) : Liquid for subcutaneous injection, 200 mg/ml. 400 mg at Week 2, and every 4 weeks thereafter until Week 362. Up to 84 months of therapy in this study."
545088|NCT00160251|B7|Baseline|Total|Total of all reporting groups
545089|NCT00160251|B6|Baseline|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545090|NCT00160251|B5|Baseline|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545091|NCT00160251|B4|Baseline|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545092|NCT00160251|B3|Baseline|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545093|NCT00160251|B2|Baseline|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545094|NCT00160251|B1|Baseline|Arm 1A: PEG + RBV OR Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
545095|NCT00160251|P8|Participant Flow|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
545096|NCT00160251|P7|Participant Flow|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545097|NCT00160251|P6|Participant Flow|ARM 4+6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545098|NCT00160251|P5|Participant Flow|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545099|NCT00160251|P4|Participant Flow|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545100|NCT00160251|P3|Participant Flow|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545101|NCT00160251|P2|Participant Flow|Arm 1B: PEG + RBV + BOC|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545102|NCT00160251|P1|Participant Flow|Arm 1A: PEG + RBV|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545103|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545104|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545105|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545106|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545107|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545108|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545109|NCT00160251|O8|Outcome|Missing Data|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545110|NCT00160251|O7|Outcome|Log Drop ≥5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545111|NCT00160251|O6|Outcome|Log Drop 4 to <5|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545112|NCT00160251|O5|Outcome|Log Drop 3 to <4|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545113|NCT00160251|O4|Outcome|Log Drop 2 to <3|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545114|NCT00160251|O3|Outcome|Log Drop 1 to <2|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545115|NCT00160251|O2|Outcome|Log Drop 0 to <1|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545116|NCT00160251|O1|Outcome|Log Drop <0|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were switched to PEG + RBV + BOC 800 for an additional 24 Weeks of Treatment.
545117|NCT00160251|O5|Outcome|Log Drop ≥5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
545118|NCT00160251|O4|Outcome|Log Drop 4 to <5|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
545119|NCT00160251|O3|Outcome|Log Drop 3 to <4|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
545120|NCT00160251|O2|Outcome|Log Drop 2 to <3|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
545121|NCT00160251|O1|Outcome|Log Drop 1 to <2|Arm 5: A single dose of PEG first, followed 1 week later by PEG + RBV + BOC 400 for 48 weeks. By protocol amendment 2, participants were switched to an increased dose of BOC 800 plus RBV with PEG for an additional 24 Weeks of Treatment.
545122|NCT00160251|O6|Outcome|Log Drop ≥5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545123|NCT00160251|O5|Outcome|Log Drop 4 to <5|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545124|NCT00160251|O4|Outcome|Log Drop 3 to <4|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545125|NCT00160251|O3|Outcome|Log Drop 2 to <3|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545126|NCT00160251|O2|Outcome|Log Drop 1 to <2|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545127|NCT00160251|O1|Outcome|Log Drop 0 to <1|All arms were given single dose of PEG first, followed 1 week later by PEG + BOC 100 for 48 weeks for Arm 2 (PEG+BOC 100), followed by PEG + BOC 200 for 48 weeks for Arm 3 (PEG+BOC 200), followed by PEG + BOC (24 or 48 weeks) for Arm 4 (PEG+BOC 400 [48 weeks]) and Arm 6 (PEG+BOC 400 [24 weeks]). By protocol amendment 2, participants were switched to an increased dose of BOC 800 TID plus RBV with PEG for an additional 24 Weeks of Treatment.
545128|NCT00160251|O8|Outcome|Arm 8: PEG + RBV + BOC 800|By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
545129|NCT00160251|O7|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545130|NCT00160251|O6|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545131|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545132|NCT00160251|O4|Outcome|Arm 3: PEG + BOC 200|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545133|NCT00160251|O3|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545134|NCT00160251|O2|Outcome|Arm 1B: PEG + RBV + BOC 400|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545135|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
545136|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545137|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545138|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545139|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545140|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545141|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545142|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545143|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545144|NCT00160251|O4|Outcome|BOC 800 mg Dose|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800 or PEG + RBV + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545145|NCT00160251|O3|Outcome|BOC 400 mg Dose|A single dose of PEG was given first, followed 1 week later by Arms 1B, 4, 5, 6, or 7. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545146|NCT00160251|O2|Outcome|BOC 200 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 3 (PEG + BOC 200). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545147|NCT00160251|O1|Outcome|BOC 100 mg Dose|A single dose of PEG was given first, followed 1 week later by Arm 2 (PEG + BOC 100). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545148|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545149|NCT00160251|O5|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545150|NCT00160251|O4|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545151|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545152|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545153|NCT00160251|O1|Outcome|Arm 1A: PEG + RBV and Arm 1B: PEG + RBV + BOC 400|"Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.~Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period."
545154|NCT00160251|O3|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545155|NCT00160251|O2|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545156|NCT00160251|O1|Outcome|Arms 2, 3, 4, 6: PEG + BOC 100, 200, or 400|A single dose of PEG was given first, followed 1 week later by PEG + BOC. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545157|NCT00160251|O4|Outcome|>12 to 36 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 12 to 36.
545158|NCT00160251|O3|Outcome|>8 to 12 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA between weeks 8 to 12.
546719|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
545160|NCT00160251|O1|Outcome|0 to ≤ 4 Weeks to First Negative HCV-RNA Group|Participants who achieved first negative HCV RNA within the first 4 weeks of treatment.
545161|NCT00160251|O6|Outcome|Arm 7: PEG + BOC 800|A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545162|NCT00160251|O5|Outcome|Arm 5: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545163|NCT00160251|O4|Outcome|Arms 4 + 6: PEG + BOC 400 (24 + 48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545164|NCT00160251|O3|Outcome|Arm 3: PEG + BOC 200 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545165|NCT00160251|O2|Outcome|Arm 2: PEG + BOC 100 (48 Weeks)|A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545166|NCT00160251|O1|Outcome|Arm 1B: PEG + RBV + BOC 400|A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545167|NCT00160251|E8|Reported Event|PEG + RBV + BOC 800|Arm 8: By protocol amendment 2, participants from all arms except Arm 1A were rolled over into PEG + RBV + BOC 800 for the remainder of the treatment period.
545168|NCT00160251|E7|Reported Event|PEG + BOC 800 (24 Weeks)|Arm 7: A single dose of PEG was given first, followed 1 week later by PEG + BOC 800. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545169|NCT00160251|E6|Reported Event|PEG + BOC 400 (24 + 48 Weeks)|Arms 4 + 6: A single dose of PEG was given first, followed 1 week later by PEG + BOC (24 or 48 weeks). By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545170|NCT00160251|E5|Reported Event|PEG + RBV + BOC 400 (48 Weeks)|Arm 5: A single dose of PEG was given first, followed 1 week later by PEG + RBV + BOC 400. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545171|NCT00160251|E4|Reported Event|PEG + BOC 200 (48 Weeks)|Arm 3: A single dose of PEG was given first, followed 1 week later by PEG + BOC 200 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545172|NCT00160251|E3|Reported Event|PEG + BOC 100 (48 Weeks)|Arm 2: A single dose of PEG was given first, followed 1 week later by PEG + BOC 100 for 48 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545173|NCT00160251|E2|Reported Event|PEG + RBV + BOC 400 (24 Weeks)|Arm 1B: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If HCV-RNA was detectable, BOC 400 was added for another 36 weeks. By protocol amendment 2, participants were rolled over into Arm 8 for the remainder of the treatment period.
545174|NCT00160251|E1|Reported Event|PEG + RBV|Arm 1A: A single dose of PEG was given first, followed 1 week later by PEG + RBV for 12 weeks. If participant was HCV-RNA negative, PEG + RBV was continued for another 36 weeks.
545175|NCT00160199|B3|Baseline|Total|Total of all reporting groups
545176|NCT00160199|B2|Baseline|Prometrium 400 mg/Day|
545177|NCT00160199|B1|Baseline|Prometrium 300 mg/Day|
545178|NCT00160199|P2|Participant Flow|Prometrium 400 mg/Day|
545179|NCT00160199|P1|Participant Flow|Prometrium 300 mg/Day|
545180|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545181|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545182|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545183|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545184|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545185|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545186|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545187|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545188|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545189|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545190|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545191|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545192|NCT00160199|O2|Outcome|Prometrium 400 mg/Day|
545193|NCT00160199|O1|Outcome|Prometrium 300 mg/Day|
545194|NCT00160199|E2|Reported Event|Prometrium 400 mg/Day|
545195|NCT00160199|E1|Reported Event|Prometrium 300 mg/Day|
545196|NCT00159965|B3|Baseline|Total|Total of all reporting groups
545197|NCT00159965|B2|Baseline|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545198|NCT00159965|B1|Baseline|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545199|NCT00159965|P2|Participant Flow|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545200|NCT00159965|P1|Participant Flow|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545201|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545202|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545203|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545204|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
546720|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
545205|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545206|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545207|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545208|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545209|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545210|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545211|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545212|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545213|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545214|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545215|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545216|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545217|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545218|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545219|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545220|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545221|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545222|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545223|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545224|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545225|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545226|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545227|NCT00159965|O2|Outcome|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545228|NCT00159965|O1|Outcome|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545229|NCT00159965|E2|Reported Event|Placebo|flexible dose placebo, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545230|NCT00159965|E1|Reported Event|Sertraline|flexible dose sertraline, 25 to 200mg titration as tolerated, administered over 12 weeks with a two week untreated lead in period monitoring their baseline NES
545231|NCT00159913|B5|Baseline|Total|Total of all reporting groups
545232|NCT00159913|B4|Baseline|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545233|NCT00159913|B3|Baseline|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545234|NCT00159913|B2|Baseline|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545235|NCT00159913|B1|Baseline|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545236|NCT00159913|P4|Participant Flow|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545237|NCT00159913|P3|Participant Flow|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545238|NCT00159913|P2|Participant Flow|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545239|NCT00159913|P1|Participant Flow|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545240|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545874|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
545241|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545242|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545243|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545244|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545245|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545246|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545247|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545248|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545249|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545250|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545251|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545252|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545253|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545254|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545255|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545256|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545257|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545258|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545259|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545260|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545261|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545262|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545263|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545264|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545265|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545266|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545267|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545268|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545269|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545270|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545271|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545272|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545273|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545274|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545275|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545276|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545277|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545278|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545279|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545280|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545281|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545282|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545283|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545284|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545285|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545286|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545287|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545288|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545289|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545290|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545291|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545292|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545293|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545294|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545295|NCT00159913|O5|Outcome|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545296|NCT00159913|O4|Outcome|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545297|NCT00159913|O3|Outcome|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545298|NCT00159913|O2|Outcome|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545299|NCT00159913|O1|Outcome|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545300|NCT00159913|E5|Reported Event|Placebo|Subjects randomized to this arm recieved placebo TID (three times daily) for 112 days.
545301|NCT00159913|E4|Reported Event|Combined Sildenafil|This includes all subjects in the low, medium and high dose groups.
545302|NCT00159913|E3|Reported Event|Sildenafil High Dose|Day 1-7 10 mg, followed by 20, 40, 80 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545303|NCT00159913|E2|Reported Event|Sildenafil Medium Dose|Day 1-7 10 mg, followed by 10, 20, 40 mg TID (3 times daily) for body weights >= 8-20 kg, > 20-45 kg, > 45 kg respectively, through Day 112
545304|NCT00159913|E1|Reported Event|Sildenafil Low Dose|"Day 1-7 10 mg, followed by 10 mg TID (3 times daily) for body weights > 20-45 kg and > 45 kg, through Day 112.~Modeling of the plasma concentrations for each dose level showed that the low and medium doses were predicted to be similar for the 8 to 20 kg subjects (ie, subjects would receive the same dose because of the available tablet strengths); consequently there was no low dose for the >= 8-20 kg weight group."
545305|NCT00159874|B8|Baseline|Total|Total of all reporting groups
545306|NCT00159874|B7|Baseline|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545307|NCT00159874|B6|Baseline|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545308|NCT00159874|B5|Baseline|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545309|NCT00159874|B4|Baseline|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545310|NCT00159874|B3|Baseline|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545311|NCT00159874|B2|Baseline|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545312|NCT00159874|B1|Baseline|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545313|NCT00159874|P7|Participant Flow|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545314|NCT00159874|P6|Participant Flow|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545315|NCT00159874|P5|Participant Flow|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545316|NCT00159874|P4|Participant Flow|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545317|NCT00159874|P3|Participant Flow|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545318|NCT00159874|P2|Participant Flow|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545319|NCT00159874|P1|Participant Flow|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545320|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545321|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545322|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545323|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545324|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545325|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545326|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545327|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545328|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545329|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545330|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545331|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545332|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545333|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545334|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545335|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545336|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545337|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545338|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545339|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545340|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545341|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545342|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545343|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545344|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545345|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545346|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545347|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545348|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545349|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545350|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545351|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545352|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545353|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545354|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545355|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545356|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545357|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545358|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545359|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545360|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545361|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545362|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545363|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545364|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545365|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545875|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
545366|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545367|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545368|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545369|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545370|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545371|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545372|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545373|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545374|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545375|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545376|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545377|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545378|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545379|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545380|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545381|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545382|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545383|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545384|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545385|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545386|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545387|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545388|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545389|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545390|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545391|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545392|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545393|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545394|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545395|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545876|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
545396|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545397|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545398|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545399|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545400|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545401|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545402|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545403|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545404|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545405|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545406|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545407|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545408|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545409|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545410|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545411|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545412|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545413|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545414|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545415|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545416|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545417|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545418|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545419|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545420|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545421|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545422|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545423|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545424|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545425|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545426|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545427|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545428|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545429|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545430|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545431|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545432|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545433|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545434|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545435|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545436|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545437|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545438|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545439|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545440|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545441|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545442|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545443|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545444|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545445|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545446|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545447|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545448|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545449|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545450|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545451|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545452|NCT00159874|O3|Outcome|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545453|NCT00159874|O2|Outcome|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545454|NCT00159874|O1|Outcome|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545455|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545456|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545457|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545458|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545459|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545460|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545461|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545877|NCT00157157|O1|Outcome|PUPs|
545878|NCT00157157|O1|Outcome|PUPs|
545462|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545463|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545464|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545465|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545466|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545467|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545468|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545469|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545470|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545471|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545472|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545473|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545474|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545475|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545476|NCT00159874|O7|Outcome|Placebo Non-randomized|This group comprised those placebo participants who either discontinued from base study A1481131 (NCT00159913) or chose not to enter study A1481156 and hence not randomly assigned to a sildenafil dose group at the start of study A1481156
545477|NCT00159874|O6|Outcome|Placebo/ High Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil high dose in study A1481156
545478|NCT00159874|O5|Outcome|Placebo/ Medium Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in study A1481156
545479|NCT00159874|O4|Outcome|Placebo/ Low Dose|Participants randomized to placebo in study A1481131 (NCT00159913) and randomized to sildenafil low dose in study A1481156
545480|NCT00159874|O3|Outcome|Sildenafil High/ High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913) and in the extension study A1481156
545481|NCT00159874|O2|Outcome|Sildenafil Medium/ Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and in the extension study A1481156
545482|NCT00159874|O1|Outcome|Sildenafil Low/Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913) and in the extension study A1481156
545483|NCT00159874|E3|Reported Event|Sildenafil High Dose|Participants randomized to sildenafil high dose in study A1481131 (NCT00159913)and continued in the high dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil high dose in the extension study A1481156
545484|NCT00159874|E2|Reported Event|Sildenafil Medium Dose|Participants randomized to sildenafil medium dose in study A1481131 (NCT00159913) and continued in the medium dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil medium dose in the extension study A1481156
545485|NCT00159874|E1|Reported Event|Sildenafil Low Dose|Participants randomized to sildenafil low dose in study A1481131 (NCT00159913)and continued in the low dose group in the extension study A1481156, and participants randomized to placebo dose in study A1481131 (NCT00159913) and randomized to sildenafil low dose in the extension study A1481156
545486|NCT00159861|B3|Baseline|Total|Total of all reporting groups
545487|NCT00159861|B2|Baseline|Sildenafil/Sildenafil|Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545488|NCT00159861|B1|Baseline|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545489|NCT00159861|P2|Participant Flow|Sildenafil: Core Study / Sildenafil: Extension Study|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545490|NCT00159861|P1|Participant Flow|Placebo: Core Study / Sildenafil: Extension Study|Core Study: Placebo (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration); Extension Study: Sildenafil (until last enrolled subject completed 3 years of treatment) - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545491|NCT00159861|O2|Outcome|Sldenafil/Sildenafil|Core Study A1481141: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545492|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study A1481141: Placebo TID (3 times daily); Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545879|NCT00157157|O1|Outcome|PUPs|
545493|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545494|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545495|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545496|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545497|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545498|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545499|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545500|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545501|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545502|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545503|NCT00159861|O2|Outcome|Sildenafil/Sildenafil|Core Study: Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study: Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545504|NCT00159861|O1|Outcome|Placebo/Sildenafil|Core Study: Placebo; Extension Study: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545505|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator.
545506|NCT00159861|O1|Outcome|All Subjects|Core Study A1481141: Placebo or Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study A1481153: Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545507|NCT00159861|E3|Reported Event|Placebo/Discontinued|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Discontinued
545508|NCT00159861|E2|Reported Event|Sildenafil/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Sildenafil 20, 40, or 80 mg TID (3 times daily) based on toleration; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID, may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545509|NCT00159861|E1|Reported Event|Placebo/Sildenafil|Core Study (16 weeks, or at least 4 weeks for subjects who required a change in epoprostenol dose due to clinical deterioration): Placebo; Extension Study (until last enrolled subject completed 3 years of treatment): Sildenafil - initial dose 20 mg TID (3 times daily), may have been increased to 40 mg TID or 80 mg TID at discretion of Investigator
545510|NCT00159822|B1|Baseline|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545511|NCT00159822|P1|Participant Flow|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545512|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545513|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545530|NCT00159783|P2|Participant Flow|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545514|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545515|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545516|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545517|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545518|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545519|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545520|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545521|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545522|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545523|NCT00159822|O1|Outcome|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545524|NCT00159822|E1|Reported Event|Voriconazole|Voriconazole (VFend®) initially administered intravenously (IV) or orally (PO) based on investigator’s clinical decision. PO loading dose every 12 hours on Day 1 for body weight ≥ 40 kilograms (kg): 400 milligrams (mg) followed by maintenance dose of 200 mg every 12 hours; or for body weight < 40 kg, loading dose every 12 hours on Day 1: 200 mg followed by maintenance dose of 100 mg every 12 hours. If initially IV, loading dose every 12 hours on Day 1: 6 mg/kg followed by maintenance dose of 4 mg/kg every 12 hours for 3 to 10 days; then, switched to PO maintenance dose based on body weight.
545525|NCT00159783|B4|Baseline|Total|Total of all reporting groups
545526|NCT00159783|B3|Baseline|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545527|NCT00159783|B2|Baseline|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545528|NCT00159783|B1|Baseline|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545529|NCT00159783|P3|Participant Flow|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545531|NCT00159783|P1|Participant Flow|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545532|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545533|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545534|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545535|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545536|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545537|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545538|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545539|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545540|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545541|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545542|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545543|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545544|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545545|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545546|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545547|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545548|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545549|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545550|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545551|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545552|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545553|NCT00159783|O1|Outcome|All Treatment Groups|Asenapine 5-10 mg twice daily for 40 weeks or Olanzapine 5-20 mg daily for 40 weeks
545554|NCT00159783|O3|Outcome|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545555|NCT00159783|O2|Outcome|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545556|NCT00159783|O1|Outcome|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545557|NCT00159783|E3|Reported Event|Olanzapine|Olanzapine 5-20 mg once daily for 40 weeks
545558|NCT00159783|E2|Reported Event|Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on asenapine in the 3 week core study)
545559|NCT00159783|E1|Reported Event|Placebo/Asenapine|Asenapine 5-10 mg twice daily for 40 weeks (participants who were on placebo during the 3 week core study)
545560|NCT00159432|B1|Baseline|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
545561|NCT00159432|P1|Participant Flow|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
545562|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
545563|NCT00159432|O1|Outcome|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85 mg/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
545564|NCT00159432|E1|Reported Event|Oxaliplatin Followed by Bevacizumab, With Capecitabine|oxaliplatin 85/m2 q 14 days, followed by bevacizumab 5 mg/kg q 14 days, with capecitabine 750 mg/m2 bid daily
545565|NCT00159419|B3|Baseline|Total|Total of all reporting groups
545566|NCT00159419|B2|Baseline|Alendronate Treatment|
545567|NCT00159419|B1|Baseline|Pamidronate Treatment|
545568|NCT00159419|P2|Participant Flow|Alendronate Treatment|
545569|NCT00159419|P1|Participant Flow|Pamidronate Treatment|
545570|NCT00159419|O2|Outcome|Alendronate|
545571|NCT00159419|O1|Outcome|Pamidronate Treatment|
545572|NCT00159419|E2|Reported Event|Alendronate Treatment|
545573|NCT00159419|E1|Reported Event|Pamidronate Treatment|Acute phase reaction with infusion
545574|NCT00158743|B3|Baseline|Total|Total of all reporting groups
545575|NCT00158743|B2|Baseline|Placebo|sodium chloride placebo
545576|NCT00158743|B1|Baseline|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
545577|NCT00158743|P2|Participant Flow|Placebo|sodium chloride placebo
545578|NCT00158743|P1|Participant Flow|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
545579|NCT00158743|O2|Outcome|Placebo|sodium chloride placebo
545580|NCT00158743|O1|Outcome|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
545581|NCT00158743|E2|Reported Event|Placebo|sodium chloride placebo
545582|NCT00158743|E1|Reported Event|Digoxin Immune Fab|"Digibind treatment plus standard of care~Anti-digoxin antibody (FAB fragment): intravenous administered, dose based on weight (assuming 4ng/mL EDLF concentration). Dose every 6 hours x 48 hours."
545584|NCT00158600|B2|Baseline|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545585|NCT00158600|B1|Baseline|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545586|NCT00158600|P2|Participant Flow|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545587|NCT00158600|P1|Participant Flow|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545588|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545589|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545590|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545591|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545592|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545593|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545594|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545595|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545596|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545597|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545598|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545599|NCT00158600|O2|Outcome|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545600|NCT00158600|O1|Outcome|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545601|NCT00158600|E3|Reported Event|Overall|
545602|NCT00158600|E2|Reported Event|Placebo|Intravenous (IV) infusions of placebo every other week (qow) for 78 weeks.
545603|NCT00158600|E1|Reported Event|Alglucosidase Alfa|Intravenous (IV) infusions of alglucosidase alfa at 20 milligrams (mg)/kilogram (kg) of body weight every other week (qow) for 78 weeks.
545604|NCT00158379|B1|Baseline|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
545605|NCT00158379|P1|Participant Flow|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
545606|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
545607|NCT00158379|O1|Outcome|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
545608|NCT00158379|E1|Reported Event|Paclitaxel|Paclitaxel: 4 cycles of Carboplatin AUC 5 every 3 weeks. 12 weekly infusions of 80 mg/m² Taxol®
545609|NCT00158249|B3|Baseline|Total|Total of all reporting groups
545610|NCT00158249|B2|Baseline|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
545611|NCT00158249|B1|Baseline|Placebo|"matched capsules~placebo: matched for physical appearance"
545612|NCT00158249|P2|Participant Flow|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
545613|NCT00158249|P1|Participant Flow|Placebo|"matched capsules~placebo: matched for physical appearance"
545614|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
545615|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
545616|NCT00158249|O2|Outcome|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
545617|NCT00158249|O1|Outcome|Placebo|"matched capsules~placebo: matched for physical appearance"
545618|NCT00158249|E2|Reported Event|Citicoline|"2 gm/day~citicoline: 2 gm/day, 8 weeks treatment"
545619|NCT00158249|E1|Reported Event|Placebo|"matched capsules~placebo: matched for physical appearance"
545620|NCT00158223|B3|Baseline|Total|Total of all reporting groups
545621|NCT00158223|B2|Baseline|Pimozide|Participants received pimozide flexible dosing
545622|NCT00158223|B1|Baseline|Placebo|Participants received encapsulated placebo made to match active drug
545623|NCT00158223|P2|Participant Flow|Pimozide|Participants received pimozide flexible dosing
545624|NCT00158223|P1|Participant Flow|Placebo|Participants received encapsulated placebo made to match active drug
545625|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
545626|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
545627|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
545628|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
545629|NCT00158223|O2|Outcome|Pimozide|Participants received pimozide flexible dosing
545630|NCT00158223|O1|Outcome|Placebo|Participants received encapsulated placebo made to match active drug
545631|NCT00158223|E2|Reported Event|Pimozide|Participants received pimozide flexible dosing
545632|NCT00158223|E1|Reported Event|Placebo|Participants received encapsulated placebo made to match active drug
545633|NCT00158197|B5|Baseline|Total|Total of all reporting groups
545634|NCT00158197|B4|Baseline|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
545709|NCT00157755|P6|Participant Flow|Idiopathic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. These subjects exited the study prior to randomization at 1.5 months.
545759|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545635|NCT00158197|B3|Baseline|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545636|NCT00158197|B2|Baseline|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545637|NCT00158197|B1|Baseline|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency managment voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545638|NCT00158197|P4|Participant Flow|Standard|Participants assigned to the standard condition did not receive vouchers for the provision of clean urines.
545639|NCT00158197|P3|Participant Flow|Intermittent Unpredictable Schedule|"Participants in the unpredictable intermittent condition earned vouchers of the same magnitude as those in the predictable intermittent condition and at approximately the same rate (i.e., $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second week of methamphetamine-negative urines, etc). More specifically, participants in this group received a voucher for $22.00 following their first three methamphetamine-negative urine tests. Following that they were eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. This date was randomly determined and they did not know in advance what day it was.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545640|NCT00158197|P2|Participant Flow|Continuous Schedule|"Those in the continuous condition received a voucher each time they tested negative for methamphetamine. The initial voucher value was $2.50. Each consecutive instance of abstinence increased the magnitude of the voucher by $1.50. Three consecutive abstinences resulted in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression could begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545641|NCT00158197|P1|Participant Flow|Intermittent Predictable Schedule|"Those in the intermittent predictable condition earned a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition received $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There were no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, resulted in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545642|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
545643|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545644|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545880|NCT00157157|O1|Outcome|PUPs|
545881|NCT00157157|O1|Outcome|PUPs|
545645|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545646|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
545647|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545648|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545649|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545650|NCT00158197|O4|Outcome|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines.
545651|NCT00158197|O3|Outcome|Intermittent Unpredictable Schedule|"Those in the intermittent unpredictable condition will be eligible to receive a voucher on one day a week. This date will be randomly determined and they will not know in advance what day it will be. Participants in this group will receive a voucher following their first three methamphetamine-negative urine tests. Following that they will be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545652|NCT00158197|O2|Outcome|Continuous Voucher Schedule|"Those in the continuous condition will receive a voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545653|NCT00158197|O1|Outcome|Intermittent Predictable Schedule|"Those in the intermittent predictable condition will earn a voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again.~contingency management voucher : participants receive vouchers for the provision of methamphetamine-negative urines. Vouchers can be redeemed for goods and services compatible with non-drug using behaviors."
545654|NCT00158197|E4|Reported Event|Standard|Participants assigned to the standard condition will not receive vouchers for the provision of clean urines. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
545710|NCT00157755|P5|Participant Flow|Idiopathic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
545760|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
546721|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
545655|NCT00158197|E3|Reported Event|Intermittent Unpredictable Schedule|Those in the intermittent unpredictable condition will be eligible to receive a contingency management voucher on one day a week. Participants in this group will receive a voucher for $22.00 following their first 3 methamphetamine-negative urine tests. They will then be eligible to receive a voucher one day a week if all of their urine tests since the receipt of their last voucher were methamphetamine negative. They will receive a voucher for $35.50 for the provision of their second set of 3 consecutive instances of methamphetamine-negative urine samples, $49.00 for their third set of 3 consecutive instances, and so forth. The day of the week on which the voucher will be available will be randomly selected for each week and the participants will not know which day of the week they will be eligible to receive a voucher until they have provided their urine test. All participants will provide observed urine samples M, W, & F for 12 wks and complete measures 1x/wk.
545656|NCT00158197|E2|Reported Event|Intermittent Predictable Schedule|Those in the intermittent predictable condition will earn a contingency management voucher when they provide three consecutive methamphetamine-negative urine tests. Participants in the intermittent predictable condition will receive $22.00 for the provision of their first three consecutive methamphetamine-negative urine samples, $35.50 for the provision of their second set of three consecutive instances of methamphetamine-negative urine samples, and so forth. There are no bonuses for consecutive instances of abstinence in the intermittent predictable condition. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
545657|NCT00158197|E1|Reported Event|Continuous Voucher Schedule|Those in the continuous condition will receive a contingency management voucher each time they test negative for methamphetamine. The initial voucher value will be $2.50. Each consecutive instance of abstinence will increase the magnitude of the voucher by $1.50. Three consecutive abstinences will result in the delivery of a $10.00 bonus. Provision of a methamphetamine-positive urine sample, or failure to test, will result in a reset in the voucher magnitude back to its original level from whence the progression can begin again. All participants will provide observed urine samples three times a week (e.g., M, W, & F) for twelve weeks and will complete study-related measures one time per week.
545658|NCT00158054|B3|Baseline|Total|Total of all reporting groups
545659|NCT00158054|B2|Baseline|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545660|NCT00158054|B1|Baseline|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545661|NCT00158054|P2|Participant Flow|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545662|NCT00158054|P1|Participant Flow|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545663|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545664|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545665|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545666|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545667|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545758|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
546722|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
545668|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545669|NCT00158054|O2|Outcome|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545670|NCT00158054|O1|Outcome|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545671|NCT00158054|E2|Reported Event|Referred Depression Care|The control condition for the trial was usual care, as defined by the patient's treating physicians. Physicians of the usual care patients were informed that their patients were participating in a trial and that they had elevated depressive symptoms; physicians were also told whether the patient met the criteria for a major depressive episode.
545672|NCT00158054|E1|Reported Event|Enhanced Depression Care|The intervention included the following 5 essential components adapted from the IMPACT study: (1) an enhanced care approach, with treatment delivered by a clinical nurse specialist, psychologist, social worker, and/or psychiatrist; (2) patient choice of psychotherapy and/or pharmacotherapy; (3) a form of psychotherapy called problem-solving therapy (PST); (4) a stepped-care approach in which symptom severity was reviewed every 8 weeks and treatment was augmented according to predetermined decision rules; and (5) a standardized instrument used to track depressive symptoms.
545673|NCT00157950|B3|Baseline|Total|Total of all reporting groups
545674|NCT00157950|B2|Baseline|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545675|NCT00157950|B1|Baseline|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545676|NCT00157950|P2|Participant Flow|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545677|NCT00157950|P1|Participant Flow|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545678|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545679|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545680|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545681|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545682|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545683|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545684|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545685|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545686|NCT00157950|O2|Outcome|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545687|NCT00157950|O1|Outcome|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545688|NCT00157950|E2|Reported Event|Placebo|Gardasil™ matching placebo 3 dose regimen (Day 1, Month 2 and Month 6)
545689|NCT00157950|E1|Reported Event|Gardasil™|Gardasil™ 3 dose regimen (Day 1, Month 2 and Month 6)
545690|NCT00157820|B4|Baseline|Total|Total of all reporting groups
545691|NCT00157820|B3|Baseline|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
545692|NCT00157820|B2|Baseline|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
545693|NCT00157820|B1|Baseline|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
545694|NCT00157820|P3|Participant Flow|DC True Then SC Sim|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm) then programmed as Single Chamber simulated"
545695|NCT00157820|P2|Participant Flow|SC Simulated Then DC True|Dual chamber ICD initially programmed as Single Chamber ICD (simulated) then DC true programmed as Dual Chamber true (DDED-DDDR) NASPE/BPEG Defibrillator/Pacemaker Codes.
545696|NCT00157820|P1|Participant Flow|SC True|Allocated to Single Chamber ICD (SC true arm) VVEV-VVI (NASPE/BPEG Defibrillator/Pacemaker Codes)
545697|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
545698|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
545699|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
545700|NCT00157820|O3|Outcome|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm"
545701|NCT00157820|O2|Outcome|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated)
545702|NCT00157820|O1|Outcome|SC True|Allocated to Single Chamber ICD (SC true arm)
545703|NCT00157820|E3|Reported Event|DC True|"Dual chamber ICD initially programmed as a DDED-DDDR (DC true arm)"
545704|NCT00157820|E2|Reported Event|SC Simulated|Dual chamber ICD initially programmed as Single Chamber ICD (simulated
545705|NCT00157820|E1|Reported Event|SC True|Allocated to Single Chamber ICD (SC true arm)
545706|NCT00157755|B3|Baseline|Total|Total of all reporting groups
545707|NCT00157755|B2|Baseline|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545708|NCT00157755|B1|Baseline|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545711|NCT00157755|P4|Participant Flow|Idiopathic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the idiopathic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
545712|NCT00157755|P3|Participant Flow|Diabetic: Not Randomized|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. These subjects exited the study prior to randomization at 1.5 months.
545713|NCT00157755|P2|Participant Flow|Diabetic: OFF First, Then ON|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device OFF for three months, followed by device ON for three months.
545714|NCT00157755|P1|Participant Flow|Diabetic: ON First, Then OFF|This group contains subjects that were enrolled and analyzed as part of the diabetic cohort. During the crossover phase of the study, this subject had the device ON for three months, followed by device OFF for three months.
545715|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545716|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545717|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545718|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545719|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545720|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545721|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545722|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545723|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545724|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545725|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545726|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545727|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545728|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545729|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545730|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545731|NCT00157755|O2|Outcome|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545732|NCT00157755|O1|Outcome|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545733|NCT00157755|E2|Reported Event|Idiopathic|This group contains all subjects that were enrolled and analyzed as part of the idiopathic cohort.
545734|NCT00157755|E1|Reported Event|Diabetic|This group contains all subjects that were enrolled and analyzed as part of the diabetic cohort.
545735|NCT00157248|B5|Baseline|Total|Total of all reporting groups
545736|NCT00157248|B4|Baseline|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
545737|NCT00157248|B3|Baseline|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
545738|NCT00157248|B2|Baseline|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
545739|NCT00157248|B1|Baseline|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
545740|NCT00157248|P4|Participant Flow|Dabigatran Etexilate, 300 mg BID (Twice Daily)|Dosage used at study start
545741|NCT00157248|P3|Participant Flow|Dabigatran Etexilate, 300 mg QD (Once Daily)|Dosage used at study start
545742|NCT00157248|P2|Participant Flow|Dabigatran Etexilate, 150 mg BID (Twice Daily)|Dosage used at study start
545743|NCT00157248|P1|Participant Flow|Dabigatran Etexilate, 150 mg QD (Once Daily)|Dosage used at study start
545744|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545745|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545746|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545747|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545748|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545749|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545750|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545751|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545752|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545753|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545754|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545755|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545756|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545757|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545761|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545762|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545763|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545764|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545765|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545766|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545767|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545768|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545769|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545770|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545771|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545772|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545773|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545774|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545775|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545776|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545777|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545778|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545779|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545780|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545781|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545782|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545783|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545784|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545785|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545786|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545787|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545788|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545789|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545790|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545791|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545792|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545793|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545794|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545795|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545796|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545797|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545798|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545799|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545800|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545801|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545802|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545803|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545804|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545805|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545806|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545807|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545808|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545809|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545810|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545811|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545812|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545813|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545814|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545815|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545816|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545817|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545818|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545819|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545820|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545821|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545822|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545823|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545824|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545825|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545826|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545827|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545828|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545829|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545830|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545831|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545832|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545833|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545834|NCT00157248|O6|Outcome|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545835|NCT00157248|O5|Outcome|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545836|NCT00157248|O4|Outcome|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545837|NCT00157248|O3|Outcome|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545838|NCT00157248|O2|Outcome|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545839|NCT00157248|O1|Outcome|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545840|NCT00157248|E6|Reported Event|300 mg Twice Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate twice daily
545841|NCT00157248|E5|Reported Event|300 mg Once Daily|Number of Participants treated at any time with 300 mg of Dabigatran etexilate once daily
545842|NCT00157248|E4|Reported Event|150 mg Twice Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate twice daily
545843|NCT00157248|E3|Reported Event|150 mg Once Daily|Number of Participants treated at any time with 150 mg of Dabigatran etexilate once daily
545844|NCT00157248|E2|Reported Event|50 mg Twice Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate twice daily
545845|NCT00157248|E1|Reported Event|50 mg Once Daily|Number of Participants treated at any time with 50 mg of Dabigatran etexilate once daily
545846|NCT00157209|B3|Baseline|Total|Total of all reporting groups
545847|NCT00157209|B2|Baseline|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545848|NCT00157209|B1|Baseline|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545849|NCT00157209|P2|Participant Flow|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545882|NCT00157157|O2|Outcome|PUPs -Termination Visit|Incremental recovery at the Termination Study Visit
545850|NCT00157209|P1|Participant Flow|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545851|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545852|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545853|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545854|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545855|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545856|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545857|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545858|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545859|NCT00157209|O2|Outcome|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545870|NCT00157157|P1|Participant Flow|Previously Untreated Patients (PUPs)|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator] or on–demand treatment [dose selected by investigator]). The dosing regimen used to treat bleeding episodes (BEs) was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episodes diagnosed.
545871|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
545872|NCT00157157|O1|Outcome|PUPs - Did Not Develop Factor VIII Inhibitor|
545860|NCT00157209|O1|Outcome|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545861|NCT00157209|E2|Reported Event|Best Supportive Care (BSC) Alone|The BSC was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545862|NCT00157209|E1|Reported Event|Tecemotide (L-BLP25) Plus Best Supportive Care (BSC)|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was given 3 days before the first vaccine treatment. After receiving cyclophosphamide, participants received 8 consecutive weekly subcutaneous vaccinations with 1000 microgram (mcg) of tecemotide (L-BLP25) at Weeks 0, 1, 2, 3, 4, 5, 6, and 7 followed by maintenance vaccinations with 1000 mcg of tecemotide (L-BLP25) at 6-week intervals, commencing at Week 13, until discontinuation from study due to ECOG status of 4, participation in alternate trial, serious adverse event, or reasons that preclude assessment of clinical status in the opinion of investigator, and incase of unavailability of study vaccine. The Best Supportive Care (BSC) was provided at the investigator's discretion, and included palliative radiation, psychosocial support, analgesics and nutritional support as required. Second-line chemotherapy was permitted when indicated for treatment of progressive disease.
545863|NCT00157196|B1|Baseline|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545864|NCT00157196|P1|Participant Flow|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 milligram per square meter (mg/m^2) (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 microgram (mcg) of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The best standard of care (BSC) was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545865|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545866|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545867|NCT00157196|O1|Outcome|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545868|NCT00157196|E1|Reported Event|Tecemotide (L-BLP25)+Cyclophosphamide+Best Standard of Care|A single intravenous infusion of 300 mg/m^2 (to a maximum 600 mg) of cyclophosphamide was administered 3 days prior to tecemotide (L-BLP25) first vaccine treatment followed by weekly subcutaneous vaccinations of 1000 mcg of tecemotide (L-BLP25) at Week 0, 1, 2, 3, 4, 5, 6, and 7 in the primary treatment phase. Maintenance dose of 1000 mcg of tecemotide (L-BLP25) was administered subcutaneously in the deltoid or triceps region of the upper arms, and the left and right anterolateral aspects of the abdomen at a 6-week intervals, starting at Week 13, until disease progression was documented. The BSC was provided at the investigator’s discretion, and included psychosocial support, nutritional support and other supportive therapies as required.
545869|NCT00157157|B1|Baseline|PUPs|
545873|NCT00157157|O2|Outcome|PUPs - Developed Factor VIII Inhibitor|
545883|NCT00157157|O1|Outcome|PUPs -Initial Visit|Incremental recovery at the Initial Study Visit
545884|NCT00157157|O3|Outcome|PUPs -During Perioperative Management|rAHF-PFM was administered intravenously via bolus infusion, or continuous infusion. The dosing regimen used was at the discretion of the investigator and in accordance with the institution’s standard of care.
545885|NCT00157157|O2|Outcome|PUPs -During On-Demand Treatment|The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of BE diagnosed.
545886|NCT00157157|O1|Outcome|PUPs -During Prophylaxis|rAHF-PFM was dosed according to a therapeutic regimen which was determined by the investigator (ie: standard regimen [25 to 50 IU/kg body weight, 3 to 4 times per week]; a modified prophylactic regimen [dose and frequency selected by investigator]. The dosing regimen used to treat BEs was at the discretion of the investigator and in accordance with the institution’s standard of care for the type of bleeding episode (BE) diagnosed.
545887|NCT00157157|O1|Outcome|PUPs|
545888|NCT00157157|O1|Outcome|PUPs|
545889|NCT00157157|O1|Outcome|PUPs|
545890|NCT00157157|O1|Outcome|PUPs|
545891|NCT00157157|E1|Reported Event|PUPs|
545892|NCT00157014|B5|Baseline|Total|Total of all reporting groups
545893|NCT00157014|B4|Baseline|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545894|NCT00157014|B3|Baseline|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545895|NCT00157014|B2|Baseline|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545896|NCT00157014|B1|Baseline|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545897|NCT00157014|P4|Participant Flow|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545898|NCT00157014|P3|Participant Flow|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545899|NCT00157014|P2|Participant Flow|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545900|NCT00157014|P1|Participant Flow|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545901|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545902|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545903|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545904|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545905|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545906|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545907|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545908|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545909|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545910|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545911|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545912|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545913|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545914|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545915|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545916|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545917|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545918|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545919|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545920|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545921|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545922|NCT00157014|O1|Outcome|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545923|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545924|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545925|NCT00157014|O2|Outcome|Cyclosporine - Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545926|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545927|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545928|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545977|NCT00156936|B3|Baseline|Total|Total of all reporting groups
545929|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545930|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545931|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545932|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545933|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545934|NCT00157014|O1|Outcome|Tacrolimus – Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545935|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545936|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545937|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545938|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545939|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545940|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545941|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545942|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545943|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545944|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545945|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545946|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545947|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545948|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545949|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545950|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545951|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545952|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545953|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545954|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545955|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545956|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545957|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545958|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545959|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545960|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545961|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545962|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545963|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545964|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545965|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545966|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545967|NCT00157014|O2|Outcome|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545968|NCT00157014|O1|Outcome|Tacrolimus - Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545969|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545970|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545971|NCT00157014|O2|Outcome|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545972|NCT00157014|O1|Outcome|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545973|NCT00157014|E4|Reported Event|Cyclosporine – Pediatric|Pediatrics: 6 – 10 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545974|NCT00157014|E3|Reported Event|Tacrolimus – Pediatric|Pediatrics: 0.05 – 0.30 mg/ kg/ day in 2-3 divided doses starting within 10 days of transplant
545975|NCT00157014|E2|Reported Event|Cyclosporine – Adult|Adults: 3-5 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545976|NCT00157014|E1|Reported Event|Tacrolimus - Adult|Adults: 0.05 – 0.10 mg/ kg/ day in 2 divided doses starting within 10 days of transplant
545978|NCT00156936|B2|Baseline|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
545979|NCT00156936|B1|Baseline|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
545980|NCT00156936|P2|Participant Flow|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
545981|NCT00156936|P1|Participant Flow|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
545982|NCT00156936|O2|Outcome|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
545983|NCT00156936|O1|Outcome|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
545984|NCT00156936|E2|Reported Event|Oral Naltrexone to Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group switched from oral naltrexone 50 mg daily in the base study to receive VIVITROL (Medisorb naltrexone 380) mg via IM injection once every 4 weeks in this extension study.
545985|NCT00156936|E1|Reported Event|Medisorb Naltrexone 380 mg (VIVITROL)|Subjects in this dosing group received VIVITROL (Medisorb naltrexone 380 mg) via intramuscular (IM) injection once every 4 weeks throughout the base study and continued on the same regimen throughout this extension.
545986|NCT00156923|B3|Baseline|Total|Total of all reporting groups
545987|NCT00156923|B2|Baseline|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
545988|NCT00156923|B1|Baseline|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
545989|NCT00156923|P2|Participant Flow|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
545990|NCT00156923|P1|Participant Flow|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
545991|NCT00156923|O2|Outcome|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
545992|NCT00156923|O1|Outcome|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
545993|NCT00156923|E2|Reported Event|Medisorb Naltrexone 190 mg|Administered via IM injection once every 4 weeks.
545994|NCT00156923|E1|Reported Event|Medisorb Naltrexone 380 mg|Administered via intramuscular (IM) injection once every 4 weeks.
545995|NCT00156910|B3|Baseline|Total|Total of all reporting groups
545996|NCT00156910|B2|Baseline|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
545997|NCT00156910|B1|Baseline|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
545998|NCT00156910|P2|Participant Flow|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
545999|NCT00156910|P1|Participant Flow|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546000|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546001|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546002|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546003|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546004|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546005|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546006|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546007|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546008|NCT00156910|O2|Outcome|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546009|NCT00156910|O1|Outcome|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546010|NCT00156910|E2|Reported Event|Placebo (Saline)|Two treatment sessions in the double-blind phase. Total minimum dose in 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas and the total maximum dose is 195 U with 39 head/neck injections.
546011|NCT00156910|E1|Reported Event|Botulinum Toxin Type A|Two treatment sessions in the double-blind phase and three treatment sessions in the open-label extension phase. Total minimum dose is 155 U with 31 fixed-site, fixed dose injections across seven specific head/neck muscle areas with the total maximum dose of 195 U with 39 head/neck injections.
546012|NCT00156819|B4|Baseline|Total|Total of all reporting groups
546013|NCT00156819|B3|Baseline|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546014|NCT00156819|B2|Baseline|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546015|NCT00156819|B1|Baseline|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546016|NCT00156819|P3|Participant Flow|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546017|NCT00156819|P2|Participant Flow|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546018|NCT00156819|P1|Participant Flow|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546019|NCT00156819|O3|Outcome|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546020|NCT00156819|O2|Outcome|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546021|NCT00156819|O1|Outcome|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546022|NCT00156819|E3|Reported Event|Fluticasone Plus Salmeterol|"Participants were given fluticasone (100 microgram) plus salmeterol (50 microgram) each night.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546023|NCT00156819|E2|Reported Event|Montelukast|"Participants were changed to Montelukast (5 or 10 mg each night).~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546024|NCT00156819|E1|Reported Event|Fluticasone|"Participants continued fluticasone (100 microgram twice daily) treatment.~fluticasone: fluticasone (100 microgram twice daily) treatment~montelukast: Montelukast (5 or 10 mg each night).~Fluticasone plus salmeterol: fluticasone (100 microgram) plus salmeterol (50 microgram) each night"
546025|NCT00156715|B1|Baseline|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
546026|NCT00156715|P1|Participant Flow|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
546027|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
546073|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
546028|NCT00156715|O1|Outcome|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
546029|NCT00156715|E1|Reported Event|QUET|After patients provided informed consent and completed baseline measures, quetiapine was initiated in all participants and titrated up to a target dose of 600 mg (in divided daily doses) over two weeks as the previous antipsychotic medication was slowly tapered and discontinued. Participants met with study physicians weekly to assess tolerability and response to the medication. Concomitant medications were held constant. After the initial titration period, quetiapine was dosed in a flexible manner up to 800 mg /day, with dose adjustments based on symptomatic response and side effects.
546030|NCT00156533|B5|Baseline|Total|Total of all reporting groups
546031|NCT00156533|B4|Baseline|CTRL|Monitor only condition.
546032|NCT00156533|B3|Baseline|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
546033|NCT00156533|B2|Baseline|QHS Zolpidem|QHS dosing with 10mg of zolpidem
546034|NCT00156533|B1|Baseline|Placebo|QHS dosing with placebo
546035|NCT00156533|P4|Participant Flow|CTRL|Monitor only condition.
546036|NCT00156533|P3|Participant Flow|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
546037|NCT00156533|P2|Participant Flow|QHS (Nightly) Zolpidem|Once nightly (QHS) dosing with 10mg of zolpidem
546038|NCT00156533|P1|Participant Flow|Placebo|Once nightly dosing (quaque hora somni [QHS])with placebo
546039|NCT00156533|O4|Outcome|CTRL|Monitor only condition.
546040|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
546041|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
546042|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
546043|NCT00156533|O4|Outcome|CTRL|Monitor only condition (no placebo and no zolpidem).
546044|NCT00156533|O3|Outcome|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed)
546045|NCT00156533|O2|Outcome|QHS Zolpidem|QHS (i.e., nightly) dosing with 10mg of zolpidem
546046|NCT00156533|O1|Outcome|Placebo|QHS (i.e., nightly) dosing with placebo
546047|NCT00156533|E4|Reported Event|CTRL|Monitor only condition.
546048|NCT00156533|E3|Reported Event|Intermittant Zolpidem|Intermittent dosing with 10mg of zolpidem (3-5 pills per week as needed
546049|NCT00156533|E2|Reported Event|QHS Zolpidem|QHS dosing with 10mg of zolpidem
546050|NCT00156533|E1|Reported Event|Placebo|QHS dosing with placebo
546051|NCT00156390|B3|Baseline|Total|Total of all reporting groups
546052|NCT00156390|B2|Baseline|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
546053|NCT00156390|B1|Baseline|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
546054|NCT00156390|P2|Participant Flow|LV Lead Placement as Per Standard of Care (Without Echo-guida|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
546055|NCT00156390|P1|Participant Flow|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
546056|NCT00156390|O2|Outcome|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
546057|NCT00156390|O1|Outcome|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
546058|NCT00156390|E2|Reported Event|LV Lead Placement as Per Standard of Care (Without Echo-guidan|"LV lead placement as per standard of care (without echo-guidance)~placement of the LV lead of the biventricular pacing device without echocardiographic guidance"
546059|NCT00156390|E1|Reported Event|Echo-guided LV Lead Placement|"echo-guided LV lead placement~echo-guided left ventricular lead placement: placement of the LV lead of the biventricular pacing device under echocardiographic guidance"
546060|NCT00156247|B1|Baseline|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546061|NCT00156247|P1|Participant Flow|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546062|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546063|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546064|NCT00156247|O1|Outcome|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546065|NCT00156247|E1|Reported Event|Etanercept With Acitretin|patients on etanercept taking open-label acitretin
546066|NCT00156065|B4|Baseline|Total|Total of all reporting groups
546067|NCT00156065|B3|Baseline|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
546068|NCT00156065|B2|Baseline|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
546069|NCT00156065|B1|Baseline|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
546070|NCT00156065|P3|Participant Flow|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
546071|NCT00156065|P2|Participant Flow|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
546072|NCT00156065|P1|Participant Flow|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
546074|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
546075|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
546076|NCT00156065|O3|Outcome|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
546077|NCT00156065|O2|Outcome|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
546078|NCT00156065|O1|Outcome|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
546079|NCT00156065|E3|Reported Event|Haloperidol/Haloperidol|Haloperidol 2-8 mg BID in Original Study and in Current Long-Term Extension
546080|NCT00156065|E2|Reported Event|Asenapine/Asenapine|Asenapine 5 or 10 mg BID in Original Study and in Current Long-Term Extension
546081|NCT00156065|E1|Reported Event|Placebo/Asenapine|Placebo in Original Study (NCT00156104) and Asenapine 5 or 10 mg BID (twice daily) in Current Long-Term Extension
546082|NCT00156013|B1|Baseline|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
546083|NCT00156013|P1|Participant Flow|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
546084|NCT00156013|O1|Outcome|Clofarabine|During the Phase I part of the study, the starting dose of clofarabine will be 4 mg/m2 administered by IVI over 1 hour for 5 consecutive days and repeated every 28 days until disease progression is observed or for a maximum of 6 cycles. Cohorts of 3 patients each will receive doses of clofarabine increased in increments of 2mg/m2. The MTD was 6mg/m2. The dose level immediately below the MTD (4mg/m2) will be used to treat patients in the Phase II part of the study.
546085|NCT00156013|E1|Reported Event|Clofarabine|Clofarabine 4 mg/m^2 days 1-5 of every cycle for a maximum of 6 cycles.
546086|NCT00153920|B1|Baseline|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546087|NCT00153920|P1|Participant Flow|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546088|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546089|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546090|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546091|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546092|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546093|NCT00153920|O1|Outcome|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546094|NCT00153920|E1|Reported Event|Bortezomib|Participants received intravenous bortezomib on a 3-week dosing cycle: 1.3 mg/m2 on days 1, 4, 8 and 11 followed by 10 day rest period for up to 8 cycles or for 2 cycles beyond complete response. Participants with progressive disease or unacceptable toxicity discontinued treatment.
546095|NCT00153816|B7|Baseline|Total|Total of all reporting groups
546096|NCT00153816|B6|Baseline|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546097|NCT00153816|B5|Baseline|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546098|NCT00153816|B4|Baseline|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546099|NCT00153816|B3|Baseline|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546100|NCT00153816|B2|Baseline|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546101|NCT00153816|B1|Baseline|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
546102|NCT00153816|P6|Participant Flow|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546103|NCT00153816|P5|Participant Flow|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546723|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
546104|NCT00153816|P4|Participant Flow|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546105|NCT00153816|P3|Participant Flow|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546106|NCT00153816|P2|Participant Flow|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546107|NCT00153816|P1|Participant Flow|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
546108|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546109|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546110|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546111|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546112|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546113|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
546114|NCT00153816|O6|Outcome|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546115|NCT00153816|O5|Outcome|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546116|NCT00153816|O4|Outcome|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546117|NCT00153816|O3|Outcome|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546118|NCT00153816|O2|Outcome|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546119|NCT00153816|O1|Outcome|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
546120|NCT00153816|E6|Reported Event|Two Arm Vitamin D|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546121|NCT00153816|E5|Reported Event|Two Arm Placebo|"Women choosing to take daily 1200 mg as calcium carbonate randomized to daily placebo~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546122|NCT00153816|E4|Reported Event|Full Factorial Calcium Plus Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate and 1000 IU vitamin D3~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546123|NCT00153816|E3|Reported Event|Full Factorial Vitamin D|"Subjects in 2X2 factorial design; randomized to daily 1000 IU vitamin D3~Vitamin D3: 1000 IU/daily; two tablets per day; 500 IU per tablet"
546124|NCT00153816|E2|Reported Event|Full Factorial Calcium|"subjects in 2X2 factorial design; randomized to daily 1200 mg as calcium carbonate~Calcium Carbonate: 3 gm/daily; 1200 mg elemental calcium/daily; two tablets per day; 600 mg elemental calcium/tablet"
546125|NCT00153816|E1|Reported Event|Full Factorial Placebo|"subjects in 2X2 factorial design; randomized to daily placebo~placebo: placebo; two tablets per day"
546126|NCT00154466|B4|Baseline|Total|Total of all reporting groups
546127|NCT00154466|B3|Baseline|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546128|NCT00154466|B2|Baseline|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546129|NCT00154466|B1|Baseline|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546130|NCT00154466|P3|Participant Flow|Healthy Controls|For comparison of myocardial perfusion and angiogenic cytokines, 19 age-, weight-, and height-matched subjects without cardiovascular risk factors were selected as healthy controls.
546131|NCT00154466|P2|Participant Flow|Post-infarction Nontraining|in which patients continued their usual lifestyle.
546132|NCT00154466|P1|Participant Flow|Post-infarction Training|which underwent a 3-month cardiac rehabilitation program
546133|NCT00154466|O3|Outcome|Healthy Controls|19 age- and sex-matched healthy volunteers
546134|NCT00154466|O2|Outcome|Post-infarction Nontraining|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546724|NCT00151892|O1|Outcome|SPD476|2.4 g/day QD
546135|NCT00154466|O1|Outcome|Post-infarction Training|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546136|NCT00154466|O2|Outcome|Post-infarction Nontraining|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
546137|NCT00154466|O1|Outcome|Post-infarction Training|Eligible patients who provided written informed consent were randomly assigned to the training group, which underwent a 3-month cardiac rehabilitation program, or the nontraining group in which patients continued their usual lifestyle. At baseline and the 3-month follow-up, all patients underwent a functional evaluation that included clinical evaluation, exercise testing, cardiac magnetic resonance imaging (MRI), and measurements of plasma angiogenic cytokines levels. Both groups were receiving stable and optimal pharmacologic treatment supervised by their physicians.
546138|NCT00154466|E3|Reported Event|Healthy Controls|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546139|NCT00154466|E2|Reported Event|Postinfarction Nontraining Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546140|NCT00154466|E1|Reported Event|Postinfarction Training Patients|39 postinfarction patients randomised to either a 3-month training group (n=20) or a nontraining group (n=19), and 19 normal controls.
546141|NCT00154375|B3|Baseline|Total|Total of all reporting groups
546142|NCT00154375|B2|Baseline|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
546143|NCT00154375|B1|Baseline|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
546144|NCT00154375|P2|Participant Flow|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
546145|NCT00154375|P1|Participant Flow|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
546146|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
546147|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
546148|NCT00154375|O2|Outcome|Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily. Every 6 weeks after randomization and based on assessment of therapeutic response, the patients were either switched to combination arm or continued in monotherapy arm of hydroxyurea.
546149|NCT00154375|O1|Outcome|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Every 6 weeks after randomization based on assessment of therapeutic response, either patients continued with above mentioned dosing regimen or switched to receive a daily dose of 800 mg imatinib with 1000 mg HU. Patients were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
546150|NCT00154375|E3|Reported Event|Period After Switch to Combination|After every 6 weeks from randomization, depending on the assessment of therapeutic effect, patients were switched from Hydroxyurea (1500 mg/day p.o) to combination arm where patients were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time).
546151|NCT00154375|E2|Reported Event|Period With Hydroxyurea Alone|1500 mg/day of HU given as 500 mg 3 times daily.
546152|NCT00154375|E1|Reported Event|Imatinib Mesylate + Hydroxyurea (HU)|Imatinib was supplied as 100 mg and 400 mg tablets. Patients in the combination arm were instructed to take a daily oral imatinib dose of 600 mg (600 mg at lunch time) and a daily oral hydroxyurea (HU) dose of 1000 mg (500 mg twice daily; in the morning and at bed time). Patients receiving a daily dose of 800 mg imatinib with 1000 mg HU were instructed to split the intake, taking 400 mg imatinib with 500 mg HU in the morning, then the same in the evening.
546153|NCT00154310|B3|Baseline|Total|Total of all reporting groups
546174|NCT00154297|P1|Participant Flow|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546154|NCT00154310|B2|Baseline|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546155|NCT00154310|B1|Baseline|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546156|NCT00154310|P2|Participant Flow|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546157|NCT00154310|P1|Participant Flow|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546158|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546159|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546160|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546161|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546162|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546163|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546164|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546165|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546166|NCT00154310|O2|Outcome|Cyclosporine + Mycophenolate Sodium|Cyclosporine tablets orally twice a day to achieve protocol specific target levels and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5mg prednisolone or equivalent and had to be continued throughout the first year.
546167|NCT00154310|O1|Outcome|Everolimus + Mycophenolate Sodium|Everolimus tablets orally twice a day to maintain a level of 6- 10 ng/mL and enteric-coated mycophenolate sodium orally twice a day to achieve a target dose of 1440 mg/day. Corticosteroids were added to the immunosuppressive regimen with a minimum dose of 5 mg prednisolone or equivalent and had to be continued throughout the first year. Cyclosporine withdrawal started from Month 4.5 post-transplant.
546168|NCT00154310|E2|Reported Event|Sandimmun Optoral|Sandimmun Optoral
546169|NCT00154310|E1|Reported Event|Certican|Certican
546170|NCT00154297|B3|Baseline|Total|Total of all reporting groups
546171|NCT00154297|B2|Baseline|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546172|NCT00154297|B1|Baseline|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546173|NCT00154297|P2|Participant Flow|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546349|NCT00153166|P1|Participant Flow|Healthy Controls|Healthy individuals, non-smokers, normal CV examination. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
546175|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546176|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546177|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546178|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546179|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546180|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546181|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546182|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546183|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546184|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546185|NCT00154297|O2|Outcome|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546186|NCT00154297|O1|Outcome|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546187|NCT00154297|E2|Reported Event|Delayed Everolimus|Patients received Everolimus 4 weeks after kidney transplant until the end of the study, administered orally twice a day. The dose was adjusted in order to maintain a trough level between 3-8 ng/mL. Patients received mycophenolic acid until everolimus was initiated.
546188|NCT00154297|E1|Reported Event|Immediate Everolimus|Patients received Everolimus starting within 48 hours of kidney transplant through to the end of the study, administered orally twice a day. Dose was adjusted in order to maintain a trough level between 3-8 ng/mL.
546189|NCT00154284|B3|Baseline|Total|Total of all reporting groups
546190|NCT00154284|B2|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546191|NCT00154284|B1|Baseline|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546192|NCT00154284|P2|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546193|NCT00154284|P1|Participant Flow|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546205|NCT00154102|B2|Baseline|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546194|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546195|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546196|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546197|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546198|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546199|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546200|NCT00154284|O2|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546201|NCT00154284|O1|Outcome|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546202|NCT00154284|E2|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Continuation|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. After randomization the target trough range remained at 3 - 8 ng/mL in the cyclosporine (Neoral) continuation groups for a period of 9 months. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546203|NCT00154284|E1|Reported Event|Everolimus (Certican) With Cyclosporine (Neoral) Withdrawal|Patients were treated with everolimus and cyclosporine for 3 months post-transplantation. Everolimus (Certican) was administered orally, in two divided doses (b.i.d), and at the same time as Cyclosporine (Neoral). Everolimus (Certican) dose was adjusted in order to maintain a trough level between 3 and 8 ng/mL until randomization. Therefore, patients were randomized to cyclosporine withdrawal over a period of 1 month (±1 week) in study A2419 (NCT00154284) and over 3 months (±1 week) in study A2423 (NCT00170807). After randomization, final target trough range for everolimus was 8 - 12 ng/mL. Each patient was administered i.v. prednisone (or equivalent) pre- or intra-operatively according to center practice.
546204|NCT00154102|B3|Baseline|Total|Total of all reporting groups
546350|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
546206|NCT00154102|B1|Baseline|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546207|NCT00154102|P2|Participant Flow|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546208|NCT00154102|P1|Participant Flow|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546209|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546210|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546211|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546212|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546213|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546214|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546215|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546216|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546217|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546218|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546219|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546220|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546221|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546222|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546223|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546224|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546351|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
546225|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546226|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546227|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546228|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546229|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546230|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546231|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546232|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546233|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546234|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546235|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546236|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546237|NCT00154102|O2|Outcome|FOLFIRI Alone|Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546238|NCT00154102|O1|Outcome|Cetuximab Plus FOLFIRI|Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops
546239|NCT00154102|E2|Reported Event|FOLFIRI Alone|"Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects"
546240|NCT00154102|E1|Reported Event|Cetuximab Plus FOLFIRI|"Cetuximab intravenous infusion of 400mg/m^2 for the first infusion then weekly intravenous infusion of 250mg/m^2. Bi-weekly Irinotecan infusion of 180mg/m^2, Folinic Acid infusion of 400mg/m^2 (racemic) or 200mg/m^2 (L-form), 5-Fluorouracil bolus of 400mg/m^2 followed by a 46-hour continuous infusion of 2400mg/m^2 Number of Cycles: until progression or unacceptable toxicity develops.~Safety population: includes all treated subjects."
546241|NCT00154063|B3|Baseline|Total|Total of all reporting groups
546242|NCT00154063|B2|Baseline|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546243|NCT00154063|B1|Baseline|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546244|NCT00154063|P2|Participant Flow|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546313|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546245|NCT00154063|P1|Participant Flow|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546246|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546247|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546248|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546249|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546250|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546251|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546252|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546253|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546254|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546255|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546256|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546257|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546258|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546259|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546260|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546261|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546262|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546263|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546264|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546265|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546266|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546314|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546267|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546268|NCT00154063|O2|Outcome|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546269|NCT00154063|O1|Outcome|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546270|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546271|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546272|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546273|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546274|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546275|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546276|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546277|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546278|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546279|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546280|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546281|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546282|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546283|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546284|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546285|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546286|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546287|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546288|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546352|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
546289|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546290|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546291|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546292|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546293|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546294|NCT00154063|O4|Outcome|E2007 (48 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546295|NCT00154063|O3|Outcome|Placebo (48 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546296|NCT00154063|O2|Outcome|E2007 (24 Hour Rule)|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546297|NCT00154063|O1|Outcome|Placebo (24 Hour Rule)|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546298|NCT00154063|E2|Reported Event|E2007|During the Titration Phase, perampanel was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546299|NCT00154063|E1|Reported Event|Placebo|During the Titration Phase, placebo was initiated at a dose of 1.0 mg/day for the first 2 weeks, increased to 1.5 mg/day for the next 2 weeks, and then further increased to 2.0 mg/day for 10 weeks (last 2 weeks of the Titration Phase continuing into the 8-week Maintenance Phase).
546300|NCT00153985|B1|Baseline|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546301|NCT00153985|P1|Participant Flow|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546302|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546303|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546304|NCT00153985|O1|Outcome|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546305|NCT00153985|E1|Reported Event|Transplant for Severe Hemoglobinopathies|Patients with severe hemoglobinopathies (eg. sickle cell disease, thalassemia major) with related donors who are identical at 6 HLA loci: (HLA-A, HLA-B, HLA-DRB1). The preparative regimen consisted of Busulfex, fludarabine and alemtuzumab.
546306|NCT00152516|B1|Baseline|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546307|NCT00152516|P1|Participant Flow|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546308|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546309|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546310|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546311|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546312|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546403|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546315|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546316|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546317|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546318|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546319|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546320|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546321|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546322|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546323|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546324|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546325|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546326|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546327|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546328|NCT00152516|O1|Outcome|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546329|NCT00152516|E1|Reported Event|Levetiracetam|Oral tablets or oral solution at 10 to 30 mg/kg/day bid for 48 weeks, or approximately 52 weeks should a subject choose to discontinue levetiracetam (LEV) at the end of the maintenance period.
546330|NCT00153179|B3|Baseline|Total|Total of all reporting groups
546331|NCT00153179|B2|Baseline|Metabolic Syndrome|
546332|NCT00153179|B1|Baseline|Healthy Controls|
546333|NCT00153179|P4|Participant Flow|Metabolic Syndrome, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
546334|NCT00153179|P3|Participant Flow|Metabolic Syndrome, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
546335|NCT00153179|P2|Participant Flow|Healthy Controls, Acipimox First, Then Placebo|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
546336|NCT00153179|P1|Participant Flow|Healthy Controls, Placebo First, Then Acipimox|The study is a randomized, placebo-controlled, double-blind, cross-over trial in subjects with the metabolic syndrome and healthy subjects with interventions assessed over one day of treatment and a washout period of 4 weeks. Acipimox (Pharmacia and Upjohn (Pfizer), Kalamazoo, MI), 250 mg, or matching placebo will be given at 7 PM, 1 AM, and 7 AM, and 11 AM prior to and on the day of study.
546337|NCT00153179|O4|Outcome|Metabolic Syndrome, Acipimox Treatment|
546338|NCT00153179|O3|Outcome|Metabolic Syndrome, Placebo Treatment|
546339|NCT00153179|O2|Outcome|Healthy Controls, Acipimox Treatment|
546340|NCT00153179|O1|Outcome|Healthy Controls, Placebo Treatment|
546341|NCT00153179|E2|Reported Event|Metabolic Syndrome|
546342|NCT00153179|E1|Reported Event|Healthy Controls|
546343|NCT00153166|B4|Baseline|Total|Total of all reporting groups
546344|NCT00153166|B3|Baseline|PAD Without Diabetes|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
546345|NCT00153166|B2|Baseline|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
546346|NCT00153166|B1|Baseline|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
546347|NCT00153166|P3|Participant Flow|PAD (Excluding Patients With Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Excluding those patients with diabetes. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
546348|NCT00153166|P2|Participant Flow|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. Randomized to atorvastatin/pioglitazone, atorvastatin/placebo, placebo/pioglitazone, or placebo/placebo.
546353|NCT00153166|O3|Outcome|PAD (Excluding Diabetes)|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less. These patients do not have diabetes.
546354|NCT00153166|O2|Outcome|Patients With PAD|Patients with PAD and stable intermittent claudication with a resting ABI of 0.90 or less.
546355|NCT00153166|O1|Outcome|Healthy Controls|Healthy individuals, non-smokers, normal CV examination.
546356|NCT00153166|E4|Reported Event|Received Placebo/Placebo|Including healthy subjects and subjects with PAD
546357|NCT00153166|E3|Reported Event|Received Placebo/Pioglitazone|Including healthy subjects and subjects with PAD
546358|NCT00153166|E2|Reported Event|Received Atorvastatin/Placebo|Including healthy subjects and subjects with PAD
546359|NCT00153166|E1|Reported Event|Received Atorvastatin/Pioglitazone|Including healthy subjects and subjects with PAD
546360|NCT00153101|B6|Baseline|Total|Total of all reporting groups
546361|NCT00153101|B5|Baseline|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546362|NCT00153101|B4|Baseline|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546363|NCT00153101|B3|Baseline|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546364|NCT00153101|B2|Baseline|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546365|NCT00153101|B1|Baseline|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546366|NCT00153101|P5|Participant Flow|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546367|NCT00153101|P4|Participant Flow|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546368|NCT00153101|P3|Participant Flow|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546369|NCT00153101|P2|Participant Flow|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546370|NCT00153101|P1|Participant Flow|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546371|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546372|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546373|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546374|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546375|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546376|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546377|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546378|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546379|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546380|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546381|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546382|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546383|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546384|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546385|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546386|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546387|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546388|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546389|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546390|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546391|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546392|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546393|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546394|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546395|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546396|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546397|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546398|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546399|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546400|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546401|NCT00153101|O2|Outcome|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546402|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546404|NCT00153101|O1|Outcome|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546405|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546406|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546407|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546408|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546409|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546410|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546411|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546412|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546413|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546414|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546415|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546416|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546417|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546418|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546419|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546420|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546421|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546422|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546423|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546424|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546425|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546426|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546427|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546428|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546429|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546430|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546431|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546432|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546433|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546434|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546435|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546436|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546437|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546438|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546439|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546440|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546441|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546442|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546443|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546444|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546669|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546445|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546446|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546447|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546448|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546449|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546450|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546451|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546452|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546453|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546454|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546455|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546456|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546457|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546458|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546459|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546460|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546461|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546462|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546463|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546464|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546465|NCT00153101|O3|Outcome|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546466|NCT00153101|O2|Outcome|Telmisartan (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546467|NCT00153101|O1|Outcome|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546468|NCT00153101|E5|Reported Event|Placebo (TRANSCEND)|Telmisartan 80mg placebo tablet, one tablet administered once daily in the morning.
546469|NCT00153101|E4|Reported Event|Telmisartan (TRANSCEND)|Telmisartan 80mg tablet, one tablet administered once daily in the morning.
546470|NCT00153101|E3|Reported Event|Ramipril (ONTARGET)|Ramipril 10mg tablet / Telmisartan 80mg placebo tablet. One tablet of each administered once daily in the morning.
546471|NCT00153101|E2|Reported Event|Telmisartan (ONTARGET)|Telmisartan 80mg tablet /Ramipril 10mg placebo tablet. One tablet of each administered once daily in the morning.
546472|NCT00153101|E1|Reported Event|Telmisartan/Ramipril (ONTARGET)|Telmisartan 80mg tablet / Ramipril 10mg tablet. One tablet of each administered once daily in the morning.
546473|NCT00153062|B5|Baseline|Total|Total of all reporting groups
546474|NCT00153062|B4|Baseline|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
546475|NCT00153062|B3|Baseline|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
546476|NCT00153062|B2|Baseline|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
546477|NCT00153062|B1|Baseline|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
546478|NCT00153062|P4|Participant Flow|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
546479|NCT00153062|P3|Participant Flow|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
546480|NCT00153062|P2|Participant Flow|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
546481|NCT00153062|P1|Participant Flow|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
546482|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
546483|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
546484|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
546485|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
546486|NCT00153062|O2|Outcome|Placebo|Consists of patients in the two treatment groups: ASA+ERDP + placebo and Clopidogrel + placebo
546487|NCT00153062|O1|Outcome|Telmisartan|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and Clopidogrel + telmisartan
546488|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
546489|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
546490|NCT00153062|O2|Outcome|Clopidogrel|Consists of patients in the two treatment groups: Clopidogrel + telmisartan and Clopidogrel + placebo
546491|NCT00153062|O1|Outcome|Aspirin + Extended Release Dipyridamole|Consists of patients in the two treatment groups: ASA+ERDP + telmisartan and ASA+ERDP + placebo
546492|NCT00153062|E4|Reported Event|Clopidogrel / Placebo|clopidogrel 75 mg, once daily, tablet / placebo tablet
546493|NCT00153062|E3|Reported Event|Clopidogrel / Telmisartan|clopidogrel 75 mg, once daily, tablet / telmisartan 80 mg, once daily, tablet
546494|NCT00153062|E2|Reported Event|Aspirin + Extended Release Dipyridamole / Placebo|25 mg aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / placebo tablet
546495|NCT00153062|E1|Reported Event|Aspirin + Extended Release Dipyridamole / Telmisartan|25 milligrams (mg) aspirin + 200 mg extended-release dipyridamole, twice daily, capsule / telmisartan 80 mg, once daily, tablet
546496|NCT00152971|B4|Baseline|Total|Total of all reporting groups
546497|NCT00152971|B3|Baseline|Enoxaparin|30mg bid (twice daily) subcutaneous
546498|NCT00152971|B2|Baseline|Dabigatran 150mg|qd (once daily) oral
546499|NCT00152971|B1|Baseline|Dabigatran 220mg|qd (once daily) oral
546500|NCT00152971|P3|Participant Flow|Enoxaparin|30mg bid (twice daily) subcutaneous
546501|NCT00152971|P2|Participant Flow|Dabigatran 150mg|qd (once daily) oral
546502|NCT00152971|P1|Participant Flow|Dabigatran 220mg|qd (once daily) oral
546503|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546504|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546505|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546506|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546507|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546508|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546509|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546510|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546511|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546512|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546513|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546514|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546515|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546516|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546517|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546518|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546519|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546520|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546521|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546522|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546523|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546524|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546525|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546526|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546527|NCT00152971|O3|Outcome|Enoxaparin|30mg bid (twice daily) subcutaneous
546528|NCT00152971|O2|Outcome|Dabigatran 150mg|qd (once daily) oral
546529|NCT00152971|O1|Outcome|Dabigatran 220mg|qd (once daily) oral
546530|NCT00152971|E3|Reported Event|Enoxaparin|30mg bid (twice daily) subcutaneous
546531|NCT00152971|E2|Reported Event|Dabigatran 150mg|qd (once daily) oral
546532|NCT00152971|E1|Reported Event|Dabigatran 220mg|qd (once daily) oral
546533|NCT00152763|B5|Baseline|Total|Total of all reporting groups
546534|NCT00152763|B4|Baseline|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546535|NCT00152763|B3|Baseline|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546536|NCT00152763|B2|Baseline|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546537|NCT00152763|B1|Baseline|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546538|NCT00152763|P4|Participant Flow|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546539|NCT00152763|P3|Participant Flow|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546540|NCT00152763|P2|Participant Flow|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546725|NCT00151892|E2|Reported Event|Asacol|1.6g/day administered 800 mg BID
546541|NCT00152763|P1|Participant Flow|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546542|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet. These data are on men and women combined within CBT.
546543|NCT00152763|O1|Outcome|Usual Cardiac Care|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed. This includes all men and women who received UCC.
546544|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546545|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546546|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546547|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546548|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546549|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546550|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546551|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546552|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546553|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546554|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546555|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546556|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546557|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546558|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546559|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546560|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546561|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546562|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546563|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546564|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546565|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546566|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546567|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546568|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546569|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546570|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546571|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546572|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546573|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546574|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546575|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546576|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546577|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546578|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546579|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546580|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546670|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546581|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546582|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546583|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546584|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546585|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546586|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546587|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546588|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546589|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546590|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546591|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546592|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546593|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546594|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546595|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546596|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546597|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546598|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546599|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546600|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546671|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546601|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546602|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546603|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546604|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546605|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546606|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546607|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546608|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546609|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546610|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546611|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546612|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546613|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546614|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546615|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546616|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546617|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546618|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546619|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546620|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546672|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546621|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546622|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546623|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546624|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546625|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546626|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546627|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546628|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546629|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546630|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546631|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546632|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546633|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546634|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546635|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546636|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546637|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546638|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546639|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546640|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546673|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546641|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546642|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546643|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546644|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546645|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546646|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546647|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546648|NCT00152763|O4|Outcome|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546649|NCT00152763|O3|Outcome|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546650|NCT00152763|O2|Outcome|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546651|NCT00152763|O1|Outcome|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546652|NCT00152763|E4|Reported Event|Cognitive Therapy Group - Men|Eight sessions of individual cognitive therapy delivered via telephone plus a psycho-educational booklet.
546653|NCT00152763|E3|Reported Event|Usual Cardiac Care - Women|Cardiac care as usual which includes standard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546654|NCT00152763|E2|Reported Event|Cognitive Behaviour Therapy - Women|Eight individual sessions of cognitive behaviour therapy delivered via telephone counselling, plus a participant psycho-educational booklet
546655|NCT00152763|E1|Reported Event|Usual Cardiac Care - Men|Cardiac care as usual for the hospital clinic which includesstandard educational materials explaining their heart disease and the ICD device. Follow-up appointments include device interrogation (i.e., to extract arrhythmia events and ICD therapies) and trouble-shooting at 6-months intervals, cardiac care as necessary, and nonsystematic supportive reassurance delivered informally in the clinic. Each centre also had access to a cardiac rehabilitation program and psychiatric consultation as needed.
546656|NCT00152009|B5|Baseline|Total|Total of all reporting groups
546657|NCT00152009|B4|Baseline|Placebo|Subjects were randomized to receive Placebo once-daily.
546658|NCT00152009|B3|Baseline|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546659|NCT00152009|B2|Baseline|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546660|NCT00152009|B1|Baseline|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546661|NCT00152009|P4|Participant Flow|Placebo|Subjects were randomized to receive Placebo once-daily.
546662|NCT00152009|P3|Participant Flow|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546663|NCT00152009|P2|Participant Flow|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546664|NCT00152009|P1|Participant Flow|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546665|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546666|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546667|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546668|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546674|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546675|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546676|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546677|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546678|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546679|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546680|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546681|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546682|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546683|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546684|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546685|NCT00152009|O4|Outcome|Placebo|Subjects were randomized to receive Placebo once-daily.
546686|NCT00152009|O3|Outcome|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546687|NCT00152009|O2|Outcome|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546688|NCT00152009|O1|Outcome|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546689|NCT00152009|E4|Reported Event|Placebo|Subjects were randomized to receive Placebo once-daily.
546690|NCT00152009|E3|Reported Event|SPD503 4mg|Subjects were randomized to receive 4 mg SPD503 (Guanfacine hydrochloride) once-daily.
546691|NCT00152009|E2|Reported Event|SPD503 3mg|Subjects were randomized to receive 3 mg SPD503 (Guanfacine hydrochloride) once-daily.
546692|NCT00152009|E1|Reported Event|SPD503 2mg|Subjects were randomized to receive 2 mg SPD503 (Guanfacine hydrochloride) once-daily.
546693|NCT00151996|B3|Baseline|Total|Total of all reporting groups
546694|NCT00151996|B2|Baseline|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546695|NCT00151996|B1|Baseline|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546696|NCT00151996|P2|Participant Flow|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546697|NCT00151996|P1|Participant Flow|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546698|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546699|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546700|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546701|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546702|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546703|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546704|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546705|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546706|NCT00151996|O2|Outcome|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546707|NCT00151996|O1|Outcome|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546708|NCT00151996|E2|Reported Event|Amphetamine + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Amphetamine was dosed according to the prescribing physician's instructions.
546709|NCT00151996|E1|Reported Event|Methylphenidate + SPD503|Each group received SPD503 (Guanfacine hydrochloride) at doses up to 4 mg/day coadministered with the psychostimulant. Methylphenidate was dosed according to the prescribing physician's instructions.
546710|NCT00151892|B3|Baseline|Total|Total of all reporting groups
546711|NCT00151892|B2|Baseline|Asacol|1.6g/day administered 800 mg BID
546712|NCT00151892|B1|Baseline|SPD476|2.4 g/day QD
546713|NCT00151892|P2|Participant Flow|Asacol|1.6g/day administered 800 mg twice daily (BID)
546714|NCT00151892|P1|Participant Flow|SPD476|2.4 g/day once daily (QD)
546715|NCT00151892|O2|Outcome|Asacol|1.6g/day administered 800 mg BID
546726|NCT00151892|E1|Reported Event|SPD476|2.4 g/day QD
546727|NCT00151814|B4|Baseline|Total|Total of all reporting groups
546728|NCT00151814|B3|Baseline|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546729|NCT00151814|B2|Baseline|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546730|NCT00151814|B1|Baseline|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546731|NCT00151814|P3|Participant Flow|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546732|NCT00151814|P2|Participant Flow|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546733|NCT00151814|P1|Participant Flow|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546734|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546735|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546736|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546737|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546738|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546739|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546740|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546741|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546742|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546743|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546744|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546745|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546746|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546747|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546748|NCT00151814|O2|Outcome|13-16 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546749|NCT00151814|O1|Outcome|6-12 Years of Age Olmesartan Group|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546921|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546750|NCT00151814|E3|Reported Event|Olmesartan Group - 13 to 16 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546751|NCT00151814|E2|Reported Event|Olmesartan Group - 6 to 12 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546752|NCT00151814|E1|Reported Event|Olmesartan Group - 2 to 5 Years Old|Hypertensive children and adolescents of both genders between the ages of 2 years and 16 years of age. The dose for children <6 years old was 0.3 mg.kg; the dose for children > or = to 6 years of age and > or = to 35 kg was 40mg; for <35 kg the dose was 20 mg.
546753|NCT00151775|B6|Baseline|Total|Total of all reporting groups
546754|NCT00151775|B5|Baseline|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546755|NCT00151775|B4|Baseline|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546756|NCT00151775|B3|Baseline|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546757|NCT00151775|B2|Baseline|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546758|NCT00151775|B1|Baseline|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546759|NCT00151775|P12|Participant Flow|Cohort C: Placebo in Period 3 (From OM in Period 2)|Subgroup of Cohort C (1-5 years old) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5).
546760|NCT00151775|P11|Participant Flow|Cohort C: OM in Periods 2, 3, 4|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period from day 0 to week 3) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period from week 3 to week 5). In Period 4 (open-label period from weeks 6-51), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546761|NCT00151775|P10|Participant Flow|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546762|NCT00151775|P9|Participant Flow|Cohort B: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
546763|NCT00151775|P8|Participant Flow|Cohort B: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan.
546764|NCT00151775|P7|Participant Flow|Cohort B: Low Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
546765|NCT00151775|P6|Participant Flow|Cohort B: High Dose OM in Periods 2, 3|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
546766|NCT00151775|P5|Participant Flow|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4 (weeks 6-51). Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546767|NCT00151775|P4|Participant Flow|Cohort A: Placebo in Period 3 (From Low Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous low dose of olmesartan.
546768|NCT00151775|P3|Participant Flow|Cohort A: Placebo in Period 3 (From High Dose in Period 2)|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given placebo during Period 3 (double-blind, placebo-controlled period from week 3 to week 5) instead of the previous high dose of olmesartan
546922|NCT00150969|E2|Reported Event|Placebo|dummy pill identicle to vitamin k
546923|NCT00150969|E1|Reported Event|Phyloquinone|5 mg Vitamin K1
546769|NCT00151775|P2|Participant Flow|Cohort A: Low Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
546770|NCT00151775|P1|Participant Flow|Cohort A: High Dose OM in Periods 2, 3|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period from day 0 to week 3). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period from week 3 to week 5).
546771|NCT00151775|O1|Outcome|Cohort C: OM (Olmesartan Medoxomil)|Cohort C (1-5 years old) was given olmesartan medoxomil (OM) 0.3 mg/kg in Period 2 (open-label period) and a subgroup of Cohort C was given that dose of OM during Period 3 (double-blind, placebo-controlled period). In Period 4 (open-label period), all of Cohort C received an OM starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546772|NCT00151775|O3|Outcome|Cohorts A + B: Period 4 Open-label OM|All members of Cohorts A + B (6-16 years old) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546773|NCT00151775|O2|Outcome|Cohort B: Period 4 Open-label OM|All members of Cohort B (6-16 years old comprised exclusively of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546774|NCT00151775|O1|Outcome|Cohort A: Period 4 Open-label OM|All members of Cohort A (6-16 years old with a limit on the number of Black participants) were given 10 mg to 40 mg of olmesartan (OM) administered as oral suspension or tablets depending on participant weight and response in the open-label Period 4. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546775|NCT00151775|O2|Outcome|Cohort C: Placebo Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group was switched from its Period 2 olmesartan dose of 0.3 mg/kg to placebo.
546776|NCT00151775|O1|Outcome|Cohort C: OM Period 3|Cohort C consisted of children from 1 to 5 years of age. There were no racial restrictions. This group continued on its Period 2 olmesartan dose of 0.3 mg/kg.
546777|NCT00151775|O6|Outcome|Cohorts A + B: Placebo Period 3|Cohorts A + B participants were 6-16 years old. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
546778|NCT00151775|O5|Outcome|Cohorts A + B: OM Period 3|Cohort A + B participants were 6-16 years old. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
546779|NCT00151775|O4|Outcome|Cohort B: Placebo Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
546780|NCT00151775|O3|Outcome|Cohort B: OM Period 3|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
546781|NCT00151775|O2|Outcome|Cohort A: Placebo Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high and low dose of olmesartan medoxomil suspension in period 2, and changed to placebo in period 3.
546782|NCT00151775|O1|Outcome|Cohort A: OM Period 3|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily in period 2, and continued that dosage into period 3.
546783|NCT00151775|O6|Outcome|Cohorts A + B: High Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the high dose of olmesartan medoxomil suspension (OM 20 mg or 40 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
546784|NCT00151775|O5|Outcome|Cohorts A + B: Low Dose OM|Subgroup from Cohorts A + B (6-16 years old) who received the low dose of olmesartan medoxomil suspension (OM 2.5 mg or 5.0 mg depending on weight), administered once daily in Period 2. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants.
546785|NCT00151775|O4|Outcome|Cohort B: High Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546786|NCT00151775|O3|Outcome|Cohort B: Low Dose OM|Subgroup of Cohort B (6-16 years old comprised exclusively of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546787|NCT00151775|O2|Outcome|Cohort A: High Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a high dose (20 mg or 40 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546924|NCT00150618|B6|Baseline|Total|Total of all reporting groups
546925|NCT00150618|B5|Baseline|Placebo|once daily
546926|NCT00150618|B4|Baseline|SPD503 (4 mg)|Guanfacine HCl once daily
546927|NCT00150618|B3|Baseline|SPD503 (3 mg)|Guanfacine HCl once daily
546788|NCT00151775|O1|Outcome|Cohort A: Low Dose OM|Subgroup of Cohort A (6-16 years old with a limit on the number of Black participants) given a low dose (2.5 mg or 5.0 mg) of olmesartan medoxomil suspension (OM) depending on weight during Period 2 (double-blind, dose-response period). Half of the participants continued this dose into Period 3 (double-blind, placebo controlled period).
546789|NCT00151775|O3|Outcome|Cohorts A + B|Cohort A + B participants were 6-16 years old. Cohort A limited the number of Black participants, while Cohort B was comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
546790|NCT00151775|O2|Outcome|Cohort B|Cohort B participants were 6-16 years old and comprised exclusively of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0 mg), depending on weight, administered once daily.
546791|NCT00151775|O1|Outcome|Cohort A|Cohort A participants were 6-16 years old with a limit on the number of Black participants. Includes participants randomized to both the high dose of olmesartan medoxomil suspension (20 mg or 40 mg) and the low dose (2.5 mg or 5.0mg), depending on weight, administered once daily.
546792|NCT00151775|E18|Reported Event|Cohort C: Period 4 Open-label OM|Participants received an olmesartan medoxomil suspension (OM) starting dose of 0.3 mg/kg. If hypertension was not controlled after two week the dose was doubled. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546793|NCT00151775|E17|Reported Event|Cohort C: Period 3 Placebo|The 0.3 mg/kg dose of olmesartan medoxomil suspension (OM) was discontinued for these participants. They were switched to placebo.
546794|NCT00151775|E16|Reported Event|Cohort C: Period 3 OM Dose Continued|The 0.3 mg/kg dose of OM was continued for these participants
546795|NCT00151775|E15|Reported Event|Cohort C: Period 2 Open-label OM|The dose of olmesartan medoxomil suspension (OM) was 0.3 mg/kg for all particpants who were 1 to 5 years of age.
546796|NCT00151775|E14|Reported Event|Cohort B: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on particpant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546797|NCT00151775|E13|Reported Event|Cohort B: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
546798|NCT00151775|E12|Reported Event|Cohort B: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
546799|NCT00151775|E11|Reported Event|Cohort B: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
546800|NCT00151775|E10|Reported Event|Cohort B: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
546801|NCT00151775|E9|Reported Event|Cohort B: Period 2 Low Dose OM|For Cohort B (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
546802|NCT00151775|E8|Reported Event|Cohort B: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
546803|NCT00151775|E7|Reported Event|Cohort A: Period 4 Open-label OM|10 mg to 40 mg of olmesartan (OM) was administered as oral suspension or tablets depending on participant weight and response. Additional antihypertensive drugs (not an angiotensin converting enzyme or angiotensin receptor blocker) were allowed if hypertension was not controlled.
546804|NCT00151775|E6|Reported Event|Cohort A: Period 3 Placebo From Low Dose|Placebo was given instead of the previous low dose of olmesartan
546805|NCT00151775|E5|Reported Event|Cohort A: Period 3 OM Low Dose Continued|The 2.5 mg or 5 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
546806|NCT00151775|E4|Reported Event|Cohort A: Period 3 Placebo From High Dose|Placebo was given instead of the previous high dose of olmesartan
546807|NCT00151775|E3|Reported Event|Cohort A: Period 3 OM High Dose Continued|The 20 mg or 40 mg dose of olmesartan medoxomil suspension (OM) from the previous period was continued.
546808|NCT00151775|E2|Reported Event|Cohort A: Period 2 Low Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 2.5 mg or 5 mg, depending on weight.
546809|NCT00151775|E1|Reported Event|Cohort A: Period 2 High Dose OM|For Cohort A (participants 6-16 years old), olmesartan medoxomil suspension (OM) providing 20 mg or 40 mg, depending on weight.
546810|NCT00151476|B4|Baseline|Total|Total of all reporting groups
546811|NCT00151476|B3|Baseline|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546812|NCT00151476|B2|Baseline|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546813|NCT00151476|B1|Baseline|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546928|NCT00150618|B2|Baseline|SPD503 (2 mg)|Guanfacine HCl once daily
546929|NCT00150618|B1|Baseline|SPD503 (1 mg)|Guanfacine HCl once daily
546930|NCT00150618|P5|Participant Flow|Placebo|once daily
546931|NCT00150618|P4|Participant Flow|SPD503 (4 mg)|Guanfacine HCl once daily
546932|NCT00150618|P3|Participant Flow|SPD503 (3 mg)|Guanfacine HCl once daily
546933|NCT00150618|P2|Participant Flow|SPD503 (2 mg)|Guanfacine HCl once daily
546814|NCT00151476|P2|Participant Flow|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546815|NCT00151476|P1|Participant Flow|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: all patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546816|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546817|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546818|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546819|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546820|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546821|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546822|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546823|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546824|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546825|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546826|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546827|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546828|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546829|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546830|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546831|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546832|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546833|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546834|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546835|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546836|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546837|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546838|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546839|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546840|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546934|NCT00150618|P1|Participant Flow|SPD503 (1 mg)|Guanfacine HCl once daily
546935|NCT00150618|O5|Outcome|Placebo|once daily
546936|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
546937|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
546841|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546842|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546843|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546844|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546845|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546846|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546847|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546848|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546849|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546850|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546851|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546852|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546853|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546854|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546855|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546856|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546857|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546858|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546859|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546860|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546861|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546862|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546863|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546864|NCT00151476|O4|Outcome|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546865|NCT00151476|O3|Outcome|Not Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; not matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546866|NCT00151476|O2|Outcome|Matched Control|Observation of subjects not treated with celecoxib and followed according to routine medical practice; matched to matched celecoxib treated subjects. Routine medical practice: All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546867|NCT00151476|O1|Outcome|Matched Celecoxib Treated|Celecoxib treatment prescribed outside clinical trial setting per routine medical care; matched to control subjects. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546938|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
546939|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
546940|NCT00150618|O5|Outcome|Placebo|once daily
546941|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
546942|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
546868|NCT00151476|E1|Reported Event|All Celecoxib Treated|All celecoxib treated subjects (includes Matched Celecoxib Treated and Not Matched Celecoxib Treated subjects); treatment prescribed outside clinical trial setting per routine medical care. Routine medical care: celecoxib is prescribed in the usual manner in accordance with the terms of the marketing authorization and as prescribed in medical practice. The assignment of the patient to celecoxib is not decided in advance by the study protocol but falls within current practice. All patients regardless of treatment status are followed according to local standard of medical care by the respective physicians.
546869|NCT00151411|B3|Baseline|Total|Total of all reporting groups
546870|NCT00151411|B2|Baseline|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
546871|NCT00151411|B1|Baseline|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
546872|NCT00151411|P2|Participant Flow|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
546873|NCT00151411|P1|Participant Flow|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
546874|NCT00151411|O2|Outcome|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
546875|NCT00151411|O1|Outcome|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
546876|NCT00151411|E2|Reported Event|Placebo|Placebo (2 tablets twice a day) initiated in a step-up fashion
546877|NCT00151411|E1|Reported Event|Metformin|Metformin 2000mg/d (2 500mg tablets taken twice a day) initiated in a step-up fashion
546878|NCT00151372|B3|Baseline|Total|Total of all reporting groups
546879|NCT00151372|B2|Baseline|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
546880|NCT00151372|B1|Baseline|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
546881|NCT00151372|P2|Participant Flow|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
546882|NCT00151372|P1|Participant Flow|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
546883|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
546884|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
546885|NCT00151372|O2|Outcome|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
546886|NCT00151372|O1|Outcome|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
546887|NCT00151372|E2|Reported Event|Enhanced Care|In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team.
546888|NCT00151372|E1|Reported Event|Treatment Adherence Intervention|In the Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease (COPD) treatment adherence and to help the participant overcome those obstacles.
546889|NCT00150969|B3|Baseline|Total|Total of all reporting groups
546890|NCT00150969|B2|Baseline|Placebo|dummy pill identicle to vitamin k
546891|NCT00150969|B1|Baseline|Phyloquinone|5 mg Vitamin K1
546892|NCT00150969|P2|Participant Flow|Placebo|dummy pill identicle to vitamin k
546893|NCT00150969|P1|Participant Flow|Phyloquinone|5 mg Vitamin K1
546894|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546895|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546896|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546897|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546898|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546899|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546900|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546901|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546902|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546903|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546904|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546905|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546906|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546907|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546908|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546909|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546910|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546911|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546912|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546913|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
546914|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546915|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1
546916|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546917|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546918|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546919|NCT00150969|O1|Outcome|Phyloquinone|5 mg Vitamin K1 daily
546920|NCT00150969|O2|Outcome|Placebo|dummy pill identicle to vitamin k
546943|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
546944|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
546945|NCT00150618|O5|Outcome|Placebo|once daily
546946|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
546947|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
546948|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
546949|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
546950|NCT00150618|O5|Outcome|Placebo|once daily
546951|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
546952|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
546953|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
546954|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
546955|NCT00150618|O5|Outcome|Placebo|once daily
546956|NCT00150618|O4|Outcome|SPD503 (4 mg)|Guanfacine HCl once daily
546957|NCT00150618|O3|Outcome|SPD503 (3 mg)|Guanfacine HCl once daily
546958|NCT00150618|O2|Outcome|SPD503 (2 mg)|Guanfacine HCl once daily
546959|NCT00150618|O1|Outcome|SPD503 (1 mg)|Guanfacine HCl once daily
546960|NCT00150618|E5|Reported Event|Placebo|once daily
546961|NCT00150618|E4|Reported Event|SPD503 (4 mg)|Guanfacine HCl once daily
546962|NCT00150618|E3|Reported Event|SPD503 (3 mg)|Guanfacine HCl once daily
546963|NCT00150618|E2|Reported Event|SPD503 (2 mg)|Guanfacine HCl once daily
546964|NCT00150618|E1|Reported Event|SPD503 (1 mg)|Guanfacine HCl once daily
546965|NCT00150592|B3|Baseline|Total|Total of all reporting groups
546966|NCT00150592|B2|Baseline|Placebo|
546967|NCT00150592|B1|Baseline|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546968|NCT00150592|P2|Participant Flow|Placebo|
546969|NCT00150592|P1|Participant Flow|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546970|NCT00150592|O2|Outcome|Placebo|
546971|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546972|NCT00150592|O2|Outcome|Placebo|
546973|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546974|NCT00150592|O2|Outcome|Placebo|
546975|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546976|NCT00150592|O2|Outcome|Placebo|
546977|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546978|NCT00150592|O2|Outcome|Placebo|
546979|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546980|NCT00150592|O2|Outcome|Placebo|
546981|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546982|NCT00150592|O2|Outcome|Placebo|
546983|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546984|NCT00150592|O2|Outcome|Placebo|
546985|NCT00150592|O1|Outcome|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546986|NCT00150592|E2|Reported Event|Placebo|
546987|NCT00150592|E1|Reported Event|SPD503|Subjects received either 1, 2, or 3 mg once-daily of SPD503 (Guanfacine hydrochloride) for 6 weeks.
546988|NCT00150462|B12|Baseline|Total|Total of all reporting groups
546989|NCT00150462|B11|Baseline|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
546990|NCT00150462|B10|Baseline|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
546991|NCT00150462|B9|Baseline|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546992|NCT00150462|B8|Baseline|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546993|NCT00150462|B7|Baseline|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546994|NCT00150462|B6|Baseline|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546995|NCT00150462|B5|Baseline|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546996|NCT00150462|B4|Baseline|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546997|NCT00150462|B3|Baseline|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546998|NCT00150462|B2|Baseline|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
546999|NCT00150462|B1|Baseline|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547000|NCT00150462|P11|Participant Flow|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547001|NCT00150462|P10|Participant Flow|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547002|NCT00150462|P9|Participant Flow|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547003|NCT00150462|P8|Participant Flow|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547004|NCT00150462|P7|Participant Flow|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547005|NCT00150462|P6|Participant Flow|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547006|NCT00150462|P5|Participant Flow|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547007|NCT00150462|P4|Participant Flow|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547008|NCT00150462|P3|Participant Flow|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547009|NCT00150462|P2|Participant Flow|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547010|NCT00150462|P1|Participant Flow|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547011|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547012|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547013|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547014|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547015|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547016|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547017|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547018|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547019|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547020|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547021|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547022|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547023|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547024|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547025|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547026|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547027|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547028|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547029|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547030|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547031|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547032|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547033|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547034|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547035|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547036|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547037|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547038|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547039|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547040|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547041|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547042|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547043|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547044|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547045|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547046|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547047|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547048|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547049|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547050|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547051|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547052|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547053|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547054|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547055|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547056|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547057|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547058|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547059|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547060|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547061|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547062|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547063|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547064|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15, and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547065|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547066|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547067|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547068|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547069|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547070|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547071|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547072|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547073|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547074|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547075|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547076|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547077|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547078|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547079|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547080|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547081|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547082|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547083|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547084|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547085|NCT00150462|O10|Outcome|CFZ 20/27 mg/m² (±DEX)|Participants in the Dose Expansion phase received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547086|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547087|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547088|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547089|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547090|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547091|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547092|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547093|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547094|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547095|NCT00150462|O11|Outcome|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547096|NCT00150462|O10|Outcome|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547097|NCT00150462|O9|Outcome|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547282|NCT00149630|O2|Outcome|Placebo CT/TT|Subjects who received placebo with genotype CT/TT.
547098|NCT00150462|O8|Outcome|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547099|NCT00150462|O7|Outcome|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547100|NCT00150462|O6|Outcome|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547101|NCT00150462|O5|Outcome|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547102|NCT00150462|O4|Outcome|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547103|NCT00150462|O3|Outcome|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547104|NCT00150462|O2|Outcome|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547105|NCT00150462|O1|Outcome|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547106|NCT00150462|E11|Reported Event|CFZ 20/27 mg/m² + DEX|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles. Participants also received 20 mg dexamethasone (DEX) administered before each dose of carfilzomib (i.e. 40 mg weekly).
547107|NCT00150462|E10|Reported Event|CFZ 20/27 mg/m²|Participants received carfilzomib 20 mg/m² administered by intravenous bolus on Cycle 1 Days 1, 2, 8, 9, 15 and 16, then 27 mg/m² in all subsequent cycles, for up to 12 cycles.
547108|NCT00150462|E9|Reported Event|CFZ 27.0 mg/m²|Participants received carfilzomib 27.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547109|NCT00150462|E8|Reported Event|CFZ 20.0 mg/m²|Participants received carfilzomib 20.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547110|NCT00150462|E7|Reported Event|CFZ 15.0 mg/m²|Participants received carfilzomib 15.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547111|NCT00150462|E6|Reported Event|CFZ 11.0 mg/m²|Participants received carfilzomib 11.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547112|NCT00150462|E5|Reported Event|CFZ 8.4 mg/m²|Participants received carfilzomib 8.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547113|NCT00150462|E4|Reported Event|CFZ 6.0 mg/m²|Participants received carfilzomib 6.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547114|NCT00150462|E3|Reported Event|CFZ 4.0 mg/m²|Participants received carfilzomib 4.0 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547115|NCT00150462|E2|Reported Event|CFZ 2.4 mg/m²|Participants received carfilzomib 2.4 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547116|NCT00150462|E1|Reported Event|CFZ 1.2 mg/m²|Participants received carfilzomib (CFZ) 1.2 mg/m² administered by intravenous bolus on Days 1, 2, 8, 9, 15 and 16 in 28-day treatment cycles for up to 12 cycles.
547117|NCT00150345|B3|Baseline|Total|Total of all reporting groups
547118|NCT00150345|B2|Baseline|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547119|NCT00150345|B1|Baseline|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547120|NCT00150345|P2|Participant Flow|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547121|NCT00150345|P1|Participant Flow|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547122|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547283|NCT00149630|O1|Outcome|Placebo CC|Subjects who received placebo with a genotype of CC.
547123|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547124|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547125|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547126|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547127|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547128|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547129|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547130|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547131|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547132|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547133|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547134|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547186|NCT00150176|P1|Participant Flow|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
547284|NCT00149630|E2|Reported Event|Placebo|Inactive medicine (placebo)with methadone during study weeks 2-13. Inactive medicine discontinued during study weeks 14-15.
547135|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547136|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547137|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547138|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547139|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547140|NCT00150345|O2|Outcome|Deferred Voricoazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547141|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547142|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547143|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547144|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547145|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547146|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547187|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
547285|NCT00149630|E1|Reported Event|Disulfarim|250 mg/day with methadone daily during study weeks 2-13. Study medicine discontinued during study weeks 14-15.
547147|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547148|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547149|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547150|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547151|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547152|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547153|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547154|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547155|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547156|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547157|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547158|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547188|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
547286|NCT00149227|B3|Baseline|Total|Total of all reporting groups
547447|NCT00147745|B2|Baseline|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547159|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547160|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547161|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547162|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547163|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547164|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547165|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547166|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547167|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547168|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547169|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547170|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547189|NCT00150176|O2|Outcome|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
547448|NCT00147745|B1|Baseline|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
548089|NCT00145626|B3|Baseline|Total|Total of all reporting groups
547171|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547172|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547173|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547174|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547175|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547176|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547177|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547178|NCT00150345|O2|Outcome|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547179|NCT00150345|O1|Outcome|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547180|NCT00150345|E2|Reported Event|Deferred Voriconazole Treatment|Placebo IV loading dose of 6 mg/kg every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). On Day 5, voriconazole IV loading dose of 6 mg/kg every 12 hours for at least 4 days (up to Day 9). Continued treatment with PO voriconazole 200 mg BID through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees C) for 7 days with neutrophil counts < 500/uL or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547181|NCT00150345|E1|Reported Event|Immediate Voriconazole|Voriconazole intravenous (IV) loading dose of 6 milligrams per kilogram (mg/kg) every 12 hours on Day 1 for the first 2 doses followed by 4 mg/kg IV every 12 hours (maintenance dose) for at least 4 days (up to Day 5). Continued treatment with oral (PO) voriconazole 200 mg twice a day (BID) through Day 28. Treatment ended if the participant was afebrile (< 38.0 degrees Celsius [C]) for 7 days with neutrophil counts < 500 per microliter (500/uL) or if participant was afebrile (< 38.0 degrees C) for 2 days with neutrophil counts > 500/uL.
547182|NCT00150176|B3|Baseline|Total|Total of all reporting groups
547183|NCT00150176|B2|Baseline|Placebo|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
547184|NCT00150176|B1|Baseline|Asenapine|Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
547185|NCT00150176|P2|Participant Flow|Placebo|Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
547190|NCT00150176|O1|Outcome|Asenapine|Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
547191|NCT00150176|E3|Reported Event|Asenapine During Open-Label Phase and Not Randomized|Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase & Not Randomized' Group includes subjects who received >= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
547192|NCT00150176|E2|Reported Event|Placebo|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
547193|NCT00150176|E1|Reported Event|Asenapine|Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.
547194|NCT00149994|B3|Baseline|Total|Total of all reporting groups
547195|NCT00149994|B2|Baseline|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
547196|NCT00149994|B1|Baseline|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
547197|NCT00149994|P2|Participant Flow|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
547198|NCT00149994|P1|Participant Flow|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
547199|NCT00149994|O2|Outcome|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
547200|NCT00149994|O1|Outcome|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
547246|NCT00149799|E1|Reported Event|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
547247|NCT00149747|B3|Baseline|Total|Total of all reporting groups
547201|NCT00149994|E2|Reported Event|Cyclosporine A|Cyclosporine A was given twice-daily at 12-hour intervals. It was administered within the first 4 hours post-operatively (study day 1), at an initial dose of 10-15mg/kg/day in two doses. Cyclosporine A was adjusted to bring the 2 hour after oral dose (C-2h) level into the target range by Days 3-5 post-transplantation. The dose of Cyclosporine A was adjusted to achieve and maintain post transplantation C-2h levels 0- 3 months: 800- 1200 ng/mL, 4- 6 months: 700- 900 ng/mL and >6 months: 500- 700 ng/mL. Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for Orthotopic Liver Transplantation (OLTx) was of auto-immune nature.
547202|NCT00149994|E1|Reported Event|Tacrolimus|Tacrolimus was given twice-daily at 12-hour intervals. Tacrolimus was administered within the first 24 hrs post- operatively (Study Day 1) at an initial dose of 0.1-0.15 mg/kg/day in two divided oral doses either by mouth or via an enteral feeding tube until the participant can swallow. The initial dosing level was determined by the participants's overall post-operative condition. The dose of tacrolimus was adjusted to achieve and maintain the pre-dose C-Oh (trough) target ranges post-transplantation 0-3 months: 10-15 ng/ml; 4-6 months: 5-10 ng/ml and > 6 months: 5-10 ng/ml . Each participant was given two 20 mg doses of Basiliximab as intravenous bolus injection at Day 0 and Day 4 post-transplant surgery. Methylprednisolone was given as an intravenous bolus of 500 mg during transplant surgery. Post-operatively prednisone was tapered from an initial dose of 20 mg/day to zero at 3 months or continued at 5-10 mg if the indication for OLTx was of auto-immune in nature.
547203|NCT00149890|B3|Baseline|Total|Total of all reporting groups
547204|NCT00149890|B2|Baseline|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547205|NCT00149890|B1|Baseline|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547206|NCT00149890|P2|Participant Flow|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547207|NCT00149890|P1|Participant Flow|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547208|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547209|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547210|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547211|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547212|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547213|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547214|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547215|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547216|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547217|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547218|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547219|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547220|NCT00149890|O2|Outcome|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547221|NCT00149890|O1|Outcome|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547222|NCT00149890|E2|Reported Event|Without Intraoperative Steroids|No intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab and the first dose of steroids had to be administered within 8 hours after reperfusion of the graft and basiliximab was given as an intravenous bolus injection.
547223|NCT00149890|E1|Reported Event|With Intraoperative Steroids|Intraoperative steroids were administered during transplantation and Basiliximab was administered on Day 0 and 4 (10 mg if the body weight was <35 kg; 20 mg if body weight was ≥35 kg) in combination with cyclosporine/cyclosporine microemulsion and steroids. Basiliximab was administered as an intravenous bolus injection within 8 hours after reperfusion of the graft.
547224|NCT00149825|B3|Baseline|Total|Total of all reporting groups
547225|NCT00149825|B2|Baseline|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
547226|NCT00149825|B1|Baseline|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
547227|NCT00149825|P2|Participant Flow|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
547228|NCT00149825|P1|Participant Flow|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
547229|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
547230|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
547231|NCT00149825|O2|Outcome|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
547232|NCT00149825|O1|Outcome|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
547233|NCT00149825|E2|Reported Event|MED+CTRL|Escitalopram plus control therapy for insomnia in depression
547234|NCT00149825|E1|Reported Event|MED+CBTI|Escitalopram plus cognitive behavioral therapy for insomnia
547235|NCT00149799|B3|Baseline|Total|Total of all reporting groups
547236|NCT00149799|B2|Baseline|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
547237|NCT00149799|B1|Baseline|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
547238|NCT00149799|P3|Participant Flow|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
547239|NCT00149799|P2|Participant Flow|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
547240|NCT00149799|P1|Participant Flow|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
547241|NCT00149799|O1|Outcome|Phase I: Open-Label Escitalopram|Participants taking 14 weeks of open-label escitalopram. Subjects received 10 mg/d weeks 1-3, 20 mg/d weeks 4-6, and 30 mg/d thereafter.
547242|NCT00149799|O2|Outcome|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
547243|NCT00149799|O1|Outcome|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
547244|NCT00149799|E3|Reported Event|Phase II: Placebo|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive placebo for an additional 6 months.
547245|NCT00149799|E2|Reported Event|Phase II: Escitalopram|At the end of the initial 14-week phase, participants who responded to open-label escitalopram were randomly assigned to receive escitalopram (same dose as received in Phase I) for an additional 6 months.
547248|NCT00149747|B2|Baseline|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547249|NCT00149747|B1|Baseline|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547250|NCT00149747|P2|Participant Flow|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547251|NCT00149747|P1|Participant Flow|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547252|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547253|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547254|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547255|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547256|NCT00149747|O2|Outcome|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547257|NCT00149747|O1|Outcome|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547258|NCT00149747|E2|Reported Event|Attention-Control (Health Education) Group|"Weekly general health education classes~Health Education Class : 2 classes a week, 90+minutes per class, general health education, excluding information on physical activity"
547259|NCT00149747|E1|Reported Event|Exercise Group|"Regular, aerobic endurance physical activity~Moderate-Intensity Aerobic Physical Activity : 4+ days per week, 60+ minutes per day, moderate or greater intensity physical activity"
547260|NCT00149643|B3|Baseline|Total|Total of all reporting groups
547261|NCT00149643|B2|Baseline|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547262|NCT00149643|B1|Baseline|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547263|NCT00149643|P2|Participant Flow|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547264|NCT00149643|P1|Participant Flow|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547265|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547266|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547267|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547268|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547269|NCT00149643|O2|Outcome|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547270|NCT00149643|O1|Outcome|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547271|NCT00149643|E2|Reported Event|Placebo|Gelatin capsules Placebo capsules,identical to Fluoxetine capsules, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of placebo, 2 capsules barring side effects.
547272|NCT00149643|E1|Reported Event|Fluoxetine|Gelatin capsules Fluoxetine 10mg, 1 capsule every a.m. Medication will be increased by one capsule, to a daily dose of fluoxetine 20mg, 2 capsules barring side effects.
547273|NCT00149630|B3|Baseline|Total|Total of all reporting groups
547274|NCT00149630|B2|Baseline|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
547275|NCT00149630|B1|Baseline|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
547276|NCT00149630|P2|Participant Flow|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
547277|NCT00149630|P1|Participant Flow|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
547278|NCT00149630|O2|Outcome|Placebo|Inactive medication (placebo) with methadone daily during study weeks 2-13. Inactive medication will be discontinued during study weeks 14-15.
547279|NCT00149630|O1|Outcome|Disulfiram|250 mg/day with methadone daily during study weeks 2-13. Medication will be discontinued during study weeks 14-15.
547280|NCT00149630|O4|Outcome|Disulfiram CT/TT|Subjects who received Disulfiram with genotype CT/TT.
547281|NCT00149630|O3|Outcome|Disulfiram CC|Subjects who received Disulfiram with genotype CC.
548531|NCT00144339|O1|Outcome|Placebo|Once daily
547287|NCT00149227|B2|Baseline|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547288|NCT00149227|B1|Baseline|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547289|NCT00149227|P2|Participant Flow|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547290|NCT00149227|P1|Participant Flow|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547291|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547292|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547293|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547294|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547295|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547296|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547297|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547298|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547299|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547300|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547301|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547302|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547303|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547304|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547305|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547328|NCT00149214|E2|Reported Event|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547306|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547307|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547308|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547309|NCT00149227|O2|Outcome|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547310|NCT00149227|O1|Outcome|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547311|NCT00149227|E2|Reported Event|Non-ARB|For the conventional treatment group, the anti-hypertensive drugs other than ARB and ACE inhibitors were provided for the patients to reach the target blood pressure.
547312|NCT00149227|E1|Reported Event|Valsartan|For the valsartan add-on group, valsartan 80 mg once daily in the morning was administered to the patient as an initial dose, the dose was doubled after 4 weeks if the initial dose could not achieve the target blood pressure of less than 140/90 mmHg (in patients with diabetes or renal disease, target blood pressure was set to less than 130/80 mmHg). After 8 weeks, an additional administration of other antihypertensive drugs with ﬂexible dosing regimen other than ARBs and ACE inhibitors was allowed if necessary.
547313|NCT00149214|B3|Baseline|Total|Total of all reporting groups
547314|NCT00149214|B2|Baseline|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547315|NCT00149214|B1|Baseline|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547316|NCT00149214|P2|Participant Flow|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547317|NCT00149214|P1|Participant Flow|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547318|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547319|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547320|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547321|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547322|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547323|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547324|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547325|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547326|NCT00149214|O2|Outcome|Cyclophosphamide Plus Doxorubicin, Followed by Docetaxel|cyclophosphamide: 600 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547327|NCT00149214|O1|Outcome|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547445|NCT00147745|B4|Baseline|Total|Total of all reporting groups
547446|NCT00147745|B3|Baseline|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547329|NCT00149214|E1|Reported Event|Pemetrexed Plus Doxorubicin, Followed by Docetaxel|pemetrexed: 500 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) doxorubicin: 60 mg/m^2, intravenous (IV), every 21 days, 4 cycles (1-4) docetaxel: 100 mg/m^2, intravenous (IV), every 21 days, 4 cycles (5-8)
547330|NCT00148954|B3|Baseline|Total|Total of all reporting groups
547331|NCT00148954|B2|Baseline|Medtronic Family|Selected Medtronic family devices
547332|NCT00148954|B1|Baseline|VITALITY 2|VITALITY 2 ICD
547333|NCT00148954|P2|Participant Flow|Medtronic Family|Selected Medtronic family devices
547334|NCT00148954|P1|Participant Flow|VITALITY 2|VITALITY 2 ICD
547335|NCT00148954|O2|Outcome|Medtronic Family|Selected Medtronic family devices
547336|NCT00148954|O1|Outcome|VITALITY 2|VITALITY 2 ICD
547337|NCT00148954|E2|Reported Event|Medtronic Family|This study did not collect serious adverse events
547338|NCT00148954|E1|Reported Event|VITALITY 2|This study did not collect serious adverse events
547339|NCT00148798|B3|Baseline|Total|Total of all reporting groups
547340|NCT00148798|B2|Baseline|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547341|NCT00148798|B1|Baseline|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547342|NCT00148798|P2|Participant Flow|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547343|NCT00148798|P1|Participant Flow|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547344|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547345|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547346|NCT00148798|O2|Outcome|Cetuximab Concentration Before Infusion Week 7|
547347|NCT00148798|O1|Outcome|Cetuximab Concentration at End of Infusion Week 1|
547348|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547349|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547350|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547351|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547352|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547353|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547354|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547355|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547356|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547357|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547358|NCT00148798|O2|Outcome|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547359|NCT00148798|O1|Outcome|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547360|NCT00148798|E2|Reported Event|Chemotherapy Alone|"cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547361|NCT00148798|E1|Reported Event|Cetuximab Plus Chemotherapy|"cetuximab given as an intravenous (i.v.) infusion every week (400mg/m^2 initial dose and 250mg/m^2 subsequent doses) until progressive disease (PD) + cisplatin 80mg/m^2 i.v. infusion on day 1 of each 3-week cycle + vinorelbine 25mg/m^2 i.v. infusion on days 1 and 8 of each 3-week cycle.~Safety population: includes all treated subjects."
547362|NCT00148759|B3|Baseline|Total|Total of all reporting groups
547363|NCT00148759|B2|Baseline|Group 2|Female subjects
547364|NCT00148759|B1|Baseline|Group 1|Male subjects
547365|NCT00148759|P2|Participant Flow|Female Arm|Female subjects
547366|NCT00148759|P1|Participant Flow|Male Arm|Male subjects
547367|NCT00148759|O2|Outcome|Group 2|Female subjects
547368|NCT00148759|O1|Outcome|Group 1|Male subjects
547369|NCT00148759|O2|Outcome|Group 2|Female subjects
547370|NCT00148759|O1|Outcome|Group 1|Male subjects
547371|NCT00148759|E2|Reported Event|Group 2|Female subjects
547372|NCT00148759|E1|Reported Event|Group 1|Male subjects
547373|NCT00148733|B3|Baseline|Total|Total of all reporting groups
547374|NCT00148733|B2|Baseline|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547375|NCT00148733|B1|Baseline|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547376|NCT00148733|P2|Participant Flow|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547377|NCT00148733|P1|Participant Flow|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547378|NCT00148733|O2|Outcome|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547379|NCT00148733|O1|Outcome|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547380|NCT00148733|E2|Reported Event|Placebo|"Placebo~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547381|NCT00148733|E1|Reported Event|Zinc|"Zinc sulphate 10 or 20 mg (elemental zinc) per day. Intervention and placebo given perorally mixed with approximately 5 mL of breastmilk or clean water~Zinc: Dissolvable zinc tablet 10 mg elemental zinc per day for infants 20 mg elemental zinc per day for children 12 to 35 months"
547382|NCT00148668|B3|Baseline|Total|Total of all reporting groups
547383|NCT00148668|B2|Baseline|Arm 2|Taxotere/carboplatin/herceptin
547384|NCT00148668|B1|Baseline|Arm 1|Herceptin/navelbine
547385|NCT00148668|P2|Participant Flow|Taxotere/Carboplatin/Herceptin|Taxotere (75mg/kg2)/carboplatin (AUC6)/herceptin(2mg/kg)[TC q 3 weeks/H q 1 wk) x 4 cycles
547386|NCT00148668|P1|Participant Flow|Herceptin/Navelbine|Herceptin( 2mg/kg)navelbine (25mg/kg2) x 12 weeks
547387|NCT00148668|O2|Outcome|Arm 2|Taxotere/carboplatin/herceptin
547388|NCT00148668|O1|Outcome|Arm 1|Herceptin/navelbine
547389|NCT00148668|E2|Reported Event|Arm 2|Taxotere/carboplatin/herceptin
547390|NCT00148668|E1|Reported Event|Arm 1|Herceptin/navelbine
547391|NCT00148122|B1|Baseline|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547392|NCT00148122|P1|Participant Flow|Docetaxel and Capecitabine|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547393|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547394|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547395|NCT00148122|O1|Outcome|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547396|NCT00148122|E1|Reported Event|Arm 1|"Docetaxel (1000mg PO BID days 5-18 of each Cycle) and Capecitabine (30mg/m2/week IV days 1, 8, &15)~Docetaxel: Each four-week cycle consists of three infusions through a vein of docetaxel, on days 1, 8, and 15. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule.~Capecitabine: Each four-week cycle consists of fourteen days of a medication that the subject will take two times a day orally, on days 5-18. If the subject's disease has decreased significantly, he/she will continue to receive docetaxel on the every four-week schedule."
547397|NCT00148109|B3|Baseline|Total|Total of all reporting groups
547398|NCT00148109|B2|Baseline|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547399|NCT00148109|B1|Baseline|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547400|NCT00148109|P2|Participant Flow|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547401|NCT00148109|P1|Participant Flow|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547402|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
547403|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
547404|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
547405|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
547406|NCT00148109|O2|Outcome|Epidermal Growth Factor Receptor Positive|Tumor did express epidermal growth factor receptor
547407|NCT00148109|O1|Outcome|Epidermal Growth Factor Receptor Negative|Tumor did not express epidermal growth factor receptor
547408|NCT00148109|E2|Reported Event|Epidermal Growth Factor Receptor Positive|Sarcoma expresses Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547409|NCT00148109|E1|Reported Event|Epidermal Growth Factor Receptor Negative|Sarcoma does not express Epidermal growth factor receptor. Patients received cetuximab 400 mg per meter squared IV followed by 250 mg per meter squared weekly
547410|NCT00147966|B1|Baseline|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
547411|NCT00147966|P1|Participant Flow|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
547412|NCT00147966|O1|Outcome|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
547413|NCT00147966|E1|Reported Event|Ritxumab|Rituximab at a dose of 1000 mg was given intravenously over 4-5 hours on day 0, and again on day 14.
547414|NCT00147823|B3|Baseline|Total|Total of all reporting groups
547415|NCT00147823|B2|Baseline|Vitoss Only|Vitoss: Synthetic bone graft material alone
547416|NCT00147823|B1|Baseline|Vitoss Used With Bone Marrow Aspirate|Vitoss: Synthetic bone graft material mixed with Bone Marrow aspirate
547417|NCT00147823|P2|Participant Flow|Vitoss With Bone Marrow Aspirate|"Addition of Vitoss to the bone marrow aspirate~Vitoss : Synthetic bone graft material"
547418|NCT00147823|P1|Participant Flow|Vitoss Alone|No bone marrow aspirate used
547419|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547420|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547421|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547422|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547423|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547424|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547425|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547426|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547427|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547428|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547429|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547430|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547431|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547432|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547433|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547434|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547435|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547436|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547437|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547438|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547439|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547440|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547441|NCT00147823|O2|Outcome|Vitoss Alone|Vitoss alone, not bone marrow aspirate used
547442|NCT00147823|O1|Outcome|Vitoss|"Addition of Vitoss to the bone marrow aspirate~Vitoss: Synthetic bone graft material"
547443|NCT00147823|E2|Reported Event|Vitoss With Bone Marrow Aspirate|subjects who received Vitoss with bone marrow aspirate
547444|NCT00147823|E1|Reported Event|Vitoss Without Bone Marrow Aspirate|subjects who received Vitoss without bone marrow aspirate
547449|NCT00147745|P3|Participant Flow|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547450|NCT00147745|P2|Participant Flow|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547451|NCT00147745|P1|Participant Flow|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547452|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547453|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547454|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547455|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547456|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547457|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547458|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547459|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547460|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547461|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547462|NCT00147745|O3|Outcome|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547463|NCT00147745|O2|Outcome|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547464|NCT00147745|O1|Outcome|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547465|NCT00147745|E3|Reported Event|Open-label Insulin Glargine|open-label Insulin Glargine for 12 weeks
547466|NCT00147745|E2|Reported Event|Colesevelam Matching Placebo|Colesevelam matching placebo for 12 weeks
547467|NCT00147745|E1|Reported Event|Colesevelam 3.8g|colesevelam 3.8g administered daily for 12 weeks
547468|NCT00147537|B5|Baseline|Total|Total of all reporting groups
547469|NCT00147537|B4|Baseline|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547470|NCT00147537|B3|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547471|NCT00147537|B2|Baseline|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547472|NCT00147537|B1|Baseline|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547473|NCT00147537|P11|Participant Flow|Paclitaxel(P)+Carboplatin(C) (Phase 2)|Paclitaxel (P) 200 mg/square meter (m^2) IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547474|NCT00147537|P10|Participant Flow|CP-751,871(F)+Paclitaxel(P)+Carboplatin(C) (Phase 2)|Single intravenous (IV) dose of CP‑751,871 (F) 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel (P) 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin (C) at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547475|NCT00147537|P9|Participant Flow|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547476|NCT00147537|P8|Participant Flow|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547477|NCT00147537|P7|Participant Flow|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547478|NCT00147537|P6|Participant Flow|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547479|NCT00147537|P5|Participant Flow|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547480|NCT00147537|P4|Participant Flow|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547481|NCT00147537|P3|Participant Flow|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547482|NCT00147537|P2|Participant Flow|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547483|NCT00147537|P1|Participant Flow|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547484|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547485|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547486|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547487|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547488|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547489|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547490|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547491|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547492|NCT00147537|O4|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2 NR)|Phase 2 Non-Randomized (NR) Extension Cohort. Single intravenous (IV) dose of CP‑751,871 20 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547493|NCT00147537|O3|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547675|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547785|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
548767|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
547494|NCT00147537|O2|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547495|NCT00147537|O1|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 mg/kg IV over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547496|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547497|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547498|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547499|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547500|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547501|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547502|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547503|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547504|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547505|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547506|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547507|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547508|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547509|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547510|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
547786|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547511|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547512|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547513|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547514|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547515|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547516|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547517|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547518|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547519|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547520|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547521|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547522|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547523|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547676|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
548010|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
547524|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547525|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547526|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547527|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547528|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547529|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547530|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547531|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547532|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547533|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547534|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547535|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547536|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547677|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
548843|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
547537|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547538|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547539|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547540|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547541|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547542|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547543|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter (mg/mL), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547544|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547545|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547546|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547547|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547548|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547549|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547678|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547787|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
548919|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
547550|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547551|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547552|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547553|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547554|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547555|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547556|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547557|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547558|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547559|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547560|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547561|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547562|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547679|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547563|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547564|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547565|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547566|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547567|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547568|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547569|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547570|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547571|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547572|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547573|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547574|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547575|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547680|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547788|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547576|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547577|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547578|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547579|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547580|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547581|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547582|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547583|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547584|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547585|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547586|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547587|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547588|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547681|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547789|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547589|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547590|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547591|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547592|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547593|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547594|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547595|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547596|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547597|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547598|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547599|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547600|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547601|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547682|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547602|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547603|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547604|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547605|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547606|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547607|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547608|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547609|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547610|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547611|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547612|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547613|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547614|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547683|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547790|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547615|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547616|NCT00147537|O8|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547617|NCT00147537|O7|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547618|NCT00147537|O6|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547619|NCT00147537|O5|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547620|NCT00147537|O4|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547621|NCT00147537|O3|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547622|NCT00147537|O2|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of Cycle 1 (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547623|NCT00147537|O1|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547624|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547625|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547626|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547627|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547684|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547791|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
550837|NCT00136695|O1|Outcome|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
547628|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547629|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547630|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547631|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547632|NCT00147537|O8|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547633|NCT00147537|O7|Outcome|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547634|NCT00147537|O6|Outcome|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547635|NCT00147537|O5|Outcome|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547636|NCT00147537|O4|Outcome|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547637|NCT00147537|O3|Outcome|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547638|NCT00147537|O2|Outcome|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547639|NCT00147537|O1|Outcome|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547640|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547685|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
548007|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
547641|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547642|NCT00147537|O2|Outcome|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547643|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547644|NCT00147537|O1|Outcome|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547645|NCT00147537|O2|Outcome|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547646|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547647|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547648|NCT00147537|O1|Outcome|CP-751,871 + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05/0.1/0.8/1.5/3/6/10/20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547649|NCT00147537|E12|Reported Event|Paclitaxel + Carboplatin + Additional CP-751,871 (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 day cycle. Participants that were considered to be in stable disease after at least 4 cycles of treatment or in progressive disease at any time during the study could receive additional cycles of treatment with CP-751,871 in combination with Paclitaxel and Carboplatin or CP-751,871 alone.
547650|NCT00147537|E11|Reported Event|Paclitaxel + Carboplatin (Phase 2)|Paclitaxel 200 mg/m^2 IV over 3 hours on Day 1 only of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target AUC of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 only of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547651|NCT00147537|E10|Reported Event|CP-751,871 + Paclitaxel + Carboplatin (Phase 2)|Single intravenous (IV) dose of CP‑751,871 10 or 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each Cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at dose to attain target area under the concentration-time curve (AUC) of 6 mg/mL*min, IV over 15‑60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547652|NCT00147537|E9|Reported Event|CP-751,871 + Paclitaxel + Carboplatin + Erlotinib (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 1 year). Erlotinib 150 mg/day orally on Cycle 1 Day 1 (up to 1 year). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547653|NCT00147537|E8|Reported Event|CP-751,871 20 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 20 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547654|NCT00147537|E7|Reported Event|CP-751,871 10 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 10 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547784|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
548087|NCT00145704|E2|Reported Event|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
547655|NCT00147537|E6|Reported Event|CP-751,871 6 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 6 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547656|NCT00147537|E5|Reported Event|CP-751,871 3 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 3 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547657|NCT00147537|E4|Reported Event|CP-751,871 1.5 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 1.5 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547658|NCT00147537|E3|Reported Event|CP-751,871 0.8 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.8 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547659|NCT00147537|E2|Reported Event|CP-751,871 0.1 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.1 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547660|NCT00147537|E1|Reported Event|CP-751,871 0.05 mg/kg + Paclitaxel + Carboplatin (Phase 1b)|Single intravenous (IV) dose of CP-751,871 0.05 milligram/kilogram (mg/kg) over 2.5 hours on Day 1 of each cycle (up to 17 cycles). Paclitaxel 200 mg/square meter (m^2), IV over 3 hours on Day 1 of each cycle (up to 6 cycles) followed by carboplatin at a dose to attain the target area under the concentration-time curve (AUC) of 6 milligram/milliliter*minute (mg/mL*min), IV over 15-60 minutes on Day 1 of each cycle (up to 6 cycles). Each cycle was 21 days cycle.
547661|NCT00146328|B4|Baseline|Total|Total of all reporting groups
547662|NCT00146328|B3|Baseline|Group 3 (Tipranavir naïve Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 449 patients were categorized into Group 3. Group 3: PI comparator arm patients from 1182.4, 1182.12 and 1182.48 who virologically failed and who then rolled into 1182.17.
547663|NCT00146328|B2|Baseline|Group 2 (Highly Treatment Experienced Patients)|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 255 patients were categorized into Group 2. Group 2: Patients from 1182.51 who rolled over into 1182.17.
547664|NCT00146328|B1|Baseline|Group 1 (Patients With Varying Degrees of Treatment Experience|A total of 995 patients who entered 1182.17 from a 'core' TPV/r trial were treated with TPV/r and were included in the integrated database. Of the 995 patients from 241 sites in 19 countries worldwide, 291 patients were categorized into Group 1. Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52, 1182.12 and 1182.48.
547665|NCT00146328|P3|Participant Flow|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547666|NCT00146328|P2|Participant Flow|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547667|NCT00146328|P1|Participant Flow|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547668|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547669|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547670|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547671|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547672|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547673|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547674|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
550838|NCT00136695|E2|Reported Event|Placebo|"placebo~anastrozole: 1 mg QD"
547686|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547687|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547688|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547689|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547690|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547691|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547692|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547693|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547694|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547695|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547696|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547697|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547698|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547699|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547700|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547701|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547702|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547703|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547704|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547705|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547706|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547707|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547708|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547709|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547710|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547711|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547712|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
548524|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
547713|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547714|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547715|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547716|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547717|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547718|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547719|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547720|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547721|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547722|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547723|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547724|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547725|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547726|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547727|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547728|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547729|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547730|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547731|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547732|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547733|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547734|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547735|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547736|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547737|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547738|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547739|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
548525|NCT00144339|O1|Outcome|Placebo|Once daily
547740|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547741|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547742|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547743|NCT00146328|O3|Outcome|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547744|NCT00146328|O2|Outcome|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547745|NCT00146328|O1|Outcome|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547746|NCT00146328|E3|Reported Event|Group 3 (Tipranavir naïve Patients)|Group 3: PI comparator arm patients from 1182.4, 1182.12 (NCT00054717) and 1182.48 (NCT00144170) who virologically failed and who then rolled into 1182.17. A total of 449 patients were categorized into Group 3.
547747|NCT00146328|E2|Reported Event|Group 2 (Highly Treatment Experienced Patients)|Group 2: Patients from 1182.51 (NCT00056641) who rolled over into 1182.17. A total of 255 patients were categorized into Group 2.
547748|NCT00146328|E1|Reported Event|Group 1 (Patients With Varying Degrees of Treatment Experience|Group 1: TPV/r patients who rolled over from Trials 1182.2, 1182.4, 1182.6, 1182.52 (NCT00275444, NCT00034866), 1182.12 (NCT00054717) and 1182.48 (NCT00144170). A total of 291 patients were categorized into Group 1.
547749|NCT00147498|B5|Baseline|Total|Total of all reporting groups
547750|NCT00147498|B4|Baseline|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547751|NCT00147498|B3|Baseline|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547752|NCT00147498|B2|Baseline|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547753|NCT00147498|B1|Baseline|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547754|NCT00147498|P4|Participant Flow|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547755|NCT00147498|P3|Participant Flow|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547756|NCT00147498|P2|Participant Flow|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547757|NCT00147498|P1|Participant Flow|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547758|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547759|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547760|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547761|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547762|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547763|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547764|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547765|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547766|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547767|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547768|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547769|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547770|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547771|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547772|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547773|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547774|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547775|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547776|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547777|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547778|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547779|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547780|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547781|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547782|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547783|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
554512|NCT00124449|B3|Baseline|Total|Total of all reporting groups
547792|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547793|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547794|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547795|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547796|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547797|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547798|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547799|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547800|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547801|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547802|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547803|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547804|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547805|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547806|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547807|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547808|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547809|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547810|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547811|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547812|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547813|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547814|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547815|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547816|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547817|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547818|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547819|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547820|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547821|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547822|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547823|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547824|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547825|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547826|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547827|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547828|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547829|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547830|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547831|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547832|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547833|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547834|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547835|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547836|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547837|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547838|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547839|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547840|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547841|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547842|NCT00147498|O4|Outcome|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547843|NCT00147498|O3|Outcome|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547844|NCT00147498|O2|Outcome|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547845|NCT00147498|O1|Outcome|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547846|NCT00147498|E4|Reported Event|Placebo|Placebo matched to CP-690,550 tablets orally twice daily for 6 weeks.
547847|NCT00147498|E3|Reported Event|CP-690,550 30 mg|CP-690,550 tablets equivalent to CP-690,550 30 mg orally twice daily for 6 weeks.
547848|NCT00147498|E2|Reported Event|CP-690,550 15 mg|CP-690,550 tablets equivalent to CP-690,550 15 mg orally twice daily for 6 weeks.
547849|NCT00147498|E1|Reported Event|CP 690,550 5 mg|CP-690,550 tablets equivalent to CP-690,550 5 milligram (mg) orally twice daily for 6 weeks.
547850|NCT00147446|B3|Baseline|Total|Total of all reporting groups
547851|NCT00147446|B2|Baseline|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participation. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
547852|NCT00147446|B1|Baseline|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for multiple sclerosis(SMT-MS)at baseline
547853|NCT00147446|P2|Participant Flow|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
547854|NCT00147446|P1|Participant Flow|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
547855|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided afte the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop.
547856|NCT00147446|O1|Outcome|Stress Management Therapy for Mulitple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
547857|NCT00147446|O2|Outcome|Wait List Control Condition|Wait list control(WLC) provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
547858|NCT00147446|O1|Outcome|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS), provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
547859|NCT00147446|E2|Reported Event|Wait List Control Condition|Wait list control provided treatment as usual for the first 10+ months of participants. A 5-hour workshop was provided after the 10th month. This allowed at least 2 post-treatment MRI evaluations that were not contaminated by the workshop
547860|NCT00147446|E1|Reported Event|Stress Management Therapy for Multiple Sclerosis|Stress management therapy for MS(SMT-MS, provided 16 individual treatment sessions over 24 weeks, followed by a 24-week post-treatment follow-up.
547861|NCT00147316|B1|Baseline|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
547862|NCT00147316|P1|Participant Flow|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
547863|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
547864|NCT00147316|O1|Outcome|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
547865|NCT00147316|E1|Reported Event|Alteplase|0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
547866|NCT00147290|B3|Baseline|Total|Total of all reporting groups
547867|NCT00147290|B2|Baseline|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
547868|NCT00147290|B1|Baseline|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
547869|NCT00147290|P2|Participant Flow|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
547870|NCT00147290|P1|Participant Flow|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
547871|NCT00147290|O2|Outcome|Biventricular (BiV)|Anti Tachyarrhythmia Pacing (ATP) are delivered in both ventricles
547872|NCT00147290|O1|Outcome|Right Ventricle (RV)|Anti Tachyarrhythmia Pacing (ATP) therapies are delivered in the right ventricle
547873|NCT00147277|B3|Baseline|Total|Total of all reporting groups
547874|NCT00147277|B2|Baseline|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547875|NCT00147277|B1|Baseline|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547876|NCT00147277|P2|Participant Flow|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547877|NCT00147277|P1|Participant Flow|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547878|NCT00147277|O2|Outcome|15 Pulses Anti-Tachycardia Pacing (ATP)|15 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547879|NCT00147277|O1|Outcome|8 Pulses Anti-Tachycardia Pacing (ATP)|8 pulses ATP delivered in the right ventricle to treat Fast Ventricular Tachycardia (FVT)
547880|NCT00147238|B1|Baseline|Ferumoxtran-10 MRI Contrast Agent|
547881|NCT00147238|P1|Participant Flow|Ferumoxtran-10 MRI Contrast Agent|
547882|NCT00147238|O1|Outcome|Ferumoxtran-10 MRI Contrast Agent|
547883|NCT00147238|E1|Reported Event|Ferumoxtran-10 MRI Contrast Agent|
547884|NCT00147225|B7|Baseline|Total|Total of all reporting groups
547885|NCT00147225|B6|Baseline|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547886|NCT00147225|B5|Baseline|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547887|NCT00147225|B4|Baseline|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
547888|NCT00147225|B3|Baseline|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547889|NCT00147225|B2|Baseline|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547890|NCT00147225|B1|Baseline|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547891|NCT00147225|P6|Participant Flow|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
547892|NCT00147225|P5|Participant Flow|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
547893|NCT00147225|P4|Participant Flow|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1, Chemotherapy (Control Cycle); Beginning Cycle 2, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy (post dose) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
547894|NCT00147225|P3|Participant Flow|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
547895|NCT00147225|P2|Participant Flow|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~AI regimen [Adriamycin 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2."
547896|NCT00147225|P1|Participant Flow|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1, Chemotherapy alone (Control Cycle); Beginning Cycle 2, Chemotherapy followed by 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later (study cycle) of 21-28 day treatment cycle.~Chemotherapy :~Carboplatin [area under the concentration curve (AUC) = 11]; or~Adriamycin /Ifosfamide (AI) regimens [Adriamycin (Doxorubicin) 75-90 mg/m^2 intravenous (IV), Ifosfamide 10-14 gm/m^2 IV]; or~High dose Ifosfamide: 14 gm/m^2"
547897|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547898|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547899|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
547900|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547901|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547902|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547903|NCT00147225|O6|Outcome|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547904|NCT00147225|O5|Outcome|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547905|NCT00147225|O4|Outcome|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
547906|NCT00147225|O3|Outcome|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547907|NCT00147225|O2|Outcome|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547908|NCT00147225|O1|Outcome|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547909|NCT00147225|E6|Reported Event|10 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547910|NCT00147225|E5|Reported Event|5 mcg/kg AMG 531 Pre/Pre/Post/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 5 mcg/kg AMG 531 for 2 doses on Days -5 and -3 (pre doses) and on day after chemotherapy and 2 days later (post doses)"
547911|NCT00147225|E4|Reported Event|10 mcg/kg Pre/Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on Day -5 (pre dose) and on day after chemotherapy"
547912|NCT00147225|E3|Reported Event|10 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 10 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547913|NCT00147225|E2|Reported Event|3 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 3 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547914|NCT00147225|E1|Reported Event|1 mcg/kg AMG 531 Post Chemotherapy|"Cycle 1: Chemotherapy~Cycle 2: Chemotherapy, 1 mcg/kg AMG 531 subcutaneously on day after chemotherapy and 2 days later"
547915|NCT00147212|B1|Baseline|Trabectedin|Experimental arm treated with trabectedin (ET-743)
547916|NCT00147212|P1|Participant Flow|Trabectedin|Experimental arm treated with trabectedin (ET-743)
547917|NCT00147212|O1|Outcome|Trabectedin|Men with metastatic castration resistant prostate cancer (CRPC) treated with trabectedin
547918|NCT00147212|E1|Reported Event|Trabectedin|Experimental arm treated with trabectedin (ET-743)
547919|NCT00147199|B3|Baseline|Total|Total of all reporting groups
547920|NCT00147199|B2|Baseline|Placebo|Identical placebo inhalation solution
547921|NCT00147199|B1|Baseline|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547922|NCT00147199|P2|Participant Flow|Placebo|Identical placebo inhalation solution
547923|NCT00147199|P1|Participant Flow|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547924|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547925|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547926|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547927|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547928|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547929|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547930|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547931|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547932|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547933|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547934|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547935|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547936|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547937|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547938|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547939|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547940|NCT00147199|O2|Outcome|Placebo|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547941|NCT00147199|O1|Outcome|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547942|NCT00147199|E2|Reported Event|Placebo|Identical placebo inhalation solution
547943|NCT00147199|E1|Reported Event|Inhaled Treprostinil|Initial dose: 3 breaths. Titrated to 9 breaths, four times daily.
547944|NCT00147030|B3|Baseline|Total|Total of all reporting groups
547945|NCT00147030|B2|Baseline|Non-cooled|Standard intensive care
547946|NCT00147030|B1|Baseline|Cooled|Whole body mild induced hypothermia 72 hours, commencing by 6 hours of age followed by re-warming to normothermia.
547947|NCT00147030|P2|Participant Flow|Non-cooled|Standard intensive care at normothermia
547948|NCT00147030|P1|Participant Flow|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547949|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547950|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547951|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547952|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547953|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547954|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547955|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547956|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547957|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547958|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547959|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
548008|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
548009|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
547960|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547961|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547962|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547963|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547964|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547965|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547966|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547967|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547968|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547969|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547970|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
547971|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547972|NCT00147030|O1|Outcome|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547973|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547974|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547975|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547976|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547977|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547978|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547979|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547980|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547981|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547982|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547983|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547984|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547985|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547986|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547987|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547988|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547989|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547990|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours; followed by normothermia.
547991|NCT00147030|O2|Outcome|Non-cooled|Standard intensive care
547992|NCT00147030|O1|Outcome|Cooled|Whole body mild induced hypothermia commencing by 6 hours of age for 72 hours, followed by normothermia.
547993|NCT00147030|E2|Reported Event|Non-cooled|Standard intensive care
547994|NCT00147030|E1|Reported Event|Cooled|"Whole body mild induced hypothermia for 72 hours, starting by 6 hours of age, in addition to standard intensive care. After 72 hours of cooling, rewarming by a maximum of 0.5 degree C / hour to normothermia.~Whole body mild induced hypothermia: Target rectal temperature 33-34°C for 72 hours, commencing by 6 hours of age; followed by re-warming at 0.5°C to normothermia"
547995|NCT00146848|B4|Baseline|Total|Total of all reporting groups
547996|NCT00146848|B3|Baseline|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
547997|NCT00146848|B2|Baseline|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
547998|NCT00146848|B1|Baseline|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
547999|NCT00146848|P3|Participant Flow|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
548000|NCT00146848|P2|Participant Flow|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
548001|NCT00146848|P1|Participant Flow|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
548002|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
548003|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
548004|NCT00146848|O1|Outcome|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
548005|NCT00146848|O3|Outcome|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
548006|NCT00146848|O2|Outcome|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
548011|NCT00146848|E3|Reported Event|DDDR-40|Rate Adaptive Pacing (atrial rate support above 40 bpm with rate responsive pacing)
548012|NCT00146848|E2|Reported Event|DDD-70|Atrial Rate Support (atrial rate support above 70 bpm)
548013|NCT00146848|E1|Reported Event|DDD-40|Atrial Tracking (atrial rate support above 40 bpm)
548014|NCT00146770|B3|Baseline|Total|Total of all reporting groups
548015|NCT00146770|B2|Baseline|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment.
548016|NCT00146770|B1|Baseline|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment.
548017|NCT00146770|P2|Participant Flow|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548018|NCT00146770|P1|Participant Flow|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548019|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548020|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548021|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548022|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548023|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548024|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548025|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548026|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548027|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548028|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548029|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548030|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548031|NCT00146770|O2|Outcome|Aldurazyme/Aldurazyme|Patients received 26 weeks of Aldurazyme treatment in the Double-Blind Study and then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 208 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement prior to randomization in the Double-Blind Study.
548032|NCT00146770|O1|Outcome|Placebo/Aldurazyme|Patients received placebo for 26 weeks in the Double-Blind Study then received 182 weeks of Aldurazyme treatment in the Extension Study; patients received a total of 182 weeks of Aldurazyme treatment. “Baseline” for this group is the last measurement in the Double-Bind Study prior to enrollment in this Extension Study.
548033|NCT00146770|E2|Reported Event|"Aldurazyme/|Aldurazyme***Check Title***"|"Aldurazyme/|Aldurazyme***Check Description***"
548034|NCT00146770|E1|Reported Event|"Placebo/|Aldurazyme***Check Title***"|"Placebo/|Aldurazyme***Check Description***"
548035|NCT00146757|B1|Baseline|Arms 1 and 2 Combined|
548088|NCT00145704|E1|Reported Event|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
548036|NCT00146757|P2|Participant Flow|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
548037|NCT00146757|P1|Participant Flow|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
548038|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548039|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548040|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548041|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548042|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548043|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548044|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
548045|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
548046|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548047|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548048|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548049|NCT00146757|O1|Outcome|Arms 1 and 2 Combined|
548050|NCT00146757|O2|Outcome|Aldurazyme (rhIDU) 100-200 U/kg Every Week|After receiving 100 Units/kg dose of Aldurazyme (rhIDU) for the first 25 weeks, patients enrolling after January 1, 2004 were eligible to receive an increased dose of 200 Units/kg from Week 26 onwards if the patient’s urinary glycosaminoglycan (uGAG) levels were >200µg/mg creatinine at Week 22.
548051|NCT00146757|O1|Outcome|Aldurazyme (rhIDU) 100 U/kg Every Week|Patients received Aldurazyme (recombinant human alpha-L-iduronidase (rhIDU)) once per week at a dose of 100 Units/kg (approximately 0.58 mg/kg) for up to 52 weeks – labeled dose.
548052|NCT00146757|E1|Reported Event|Aldurazyme ***Check Title***|Aldurazyme ***check title***
548053|NCT00145795|B3|Baseline|Total|Total of all reporting groups
548054|NCT00145795|B2|Baseline|Current Regimen|Patients in this study arm continued their current regimen.
548055|NCT00145795|B1|Baseline|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548056|NCT00145795|P2|Participant Flow|Current Regimen|Patients in this study arm continued their current regimen.
548057|NCT00145795|P1|Participant Flow|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548058|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548059|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548060|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548061|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548062|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548063|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548064|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548065|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548066|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548067|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548068|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548069|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548070|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548071|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548072|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548073|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548074|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548075|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548076|NCT00145795|O2|Outcome|Current Regimen|Patients in this study arm continued their current regimen.
548077|NCT00145795|O1|Outcome|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548078|NCT00145795|E2|Reported Event|Current Regimen|Patients in this study arm continued their current regimen.
548079|NCT00145795|E1|Reported Event|Kaletra + Current Dual NRTI Backbone|Patients in this arm received Kaletra in addition to their current Dual NRTI Backbone.
548080|NCT00145704|B3|Baseline|Total|Total of all reporting groups
548081|NCT00145704|B2|Baseline|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
548082|NCT00145704|B1|Baseline|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
548083|NCT00145704|P2|Participant Flow|Growth Hormone Only|Growth hormone only, no bisphosphonate will be used
548084|NCT00145704|P1|Participant Flow|Bisphosphonate and Growth Hormone|bisphosphonate use and growth hormone use
548085|NCT00145704|O2|Outcome|Growth Hormone Only|Growth hormone use only, no bisphosphonate used
548086|NCT00145704|O1|Outcome|Bisphosphonate and Growth Hormone Use|bisphosphonate use and growth hormone use
548090|NCT00145626|B2|Baseline|Expired|"Those participants who did not survive to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548091|NCT00145626|B1|Baseline|Alive|"Group of participants who survived to at least one year post HSCT.~Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548092|NCT00145626|P1|Participant Flow|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548093|NCT00145626|O3|Outcome|Study Participants|"MRD data were collected on four study participants. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548094|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548095|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548096|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548097|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548098|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548099|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548100|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548101|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548102|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548103|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548104|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548105|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548106|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548107|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548108|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548109|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548110|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548111|NCT00145626|O3|Outcome|Study Participants|"Fourteen study participants were evaluable for the outcome measures. Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548112|NCT00145626|O2|Outcome|Expired|Those participants who did not survive to at least one year post HSCT.
548113|NCT00145626|O1|Outcome|Alive|Group of participants who survived to at least one year post HSCT.
548114|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548115|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548116|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548117|NCT00145626|O1|Outcome|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days posttransplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548118|NCT00145626|E1|Reported Event|Study Participants|"Study participants received a non-TBI based preparative regimen consisting of Cyclophosphamide, fludarabine, thiotepa, melphalan, and muromonab-CD3 (OKT3) followed by an infusion of a T-lymphocyte depleted haploidentical hematopoietic stem cell graft. Seven days post-transplant, participants received an infusion of additional donor derived cells called natural killer (NK) cells.~Stem cells were obtained from donors using the Miltenyi Biotec CliniMACS stem cell selection device."
548119|NCT00145600|B5|Baseline|Total|Total of all reporting groups
548120|NCT00145600|B4|Baseline|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
548121|NCT00145600|B3|Baseline|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
548122|NCT00145600|B2|Baseline|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
548123|NCT00145600|B1|Baseline|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
548124|NCT00145600|P4|Participant Flow|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
548125|NCT00145600|P3|Participant Flow|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
548126|NCT00145600|P2|Participant Flow|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
548127|NCT00145600|P1|Participant Flow|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
548128|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548129|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548130|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548131|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548132|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548133|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548134|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548135|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548136|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548137|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548138|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548139|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548140|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548141|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548142|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548143|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548144|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548145|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548146|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548147|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548148|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548149|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548150|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548151|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548152|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548153|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548154|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548155|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548156|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548157|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548158|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548159|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548160|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548161|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548162|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548163|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548164|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548165|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548166|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548167|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548168|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548169|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548170|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548171|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548172|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548173|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548174|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548175|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548176|NCT00145600|O6|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548177|NCT00145600|O5|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548178|NCT00145600|O4|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548179|NCT00145600|O3|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548180|NCT00145600|O2|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548181|NCT00145600|O1|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548182|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548183|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548184|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548185|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548186|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548187|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548188|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548189|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548190|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548191|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548192|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548193|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548194|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548195|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548196|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548197|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548198|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548199|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548200|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548201|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548202|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548203|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548204|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548205|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548206|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548207|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548208|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548209|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548210|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548211|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548212|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548213|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548214|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548215|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548216|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548217|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548218|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548219|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548220|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548221|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548222|NCT00145600|O8|Outcome|Parent 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548223|NCT00145600|O7|Outcome|Patient 3-6 Months After the Completion of Therapy (T5)|Patients and parents were assessed for quality of life at 3-6 months after the completion of therapy (T5).
548224|NCT00145600|O6|Outcome|Parent Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548225|NCT00145600|O5|Outcome|Patient Completion of 4 Cycles of Chemotherapy (T3)|Patients and parents were assessed for quality of life at completion of 4 cycles of chemotherapy (T3).
548226|NCT00145600|O4|Outcome|Parent Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548227|NCT00145600|O3|Outcome|Patient Completion of 2 Cycles of Chemotherapy (T2)|Patients and parents were assessed for quality of life at completion of 2 cycles of chemotherapy (T2).
548228|NCT00145600|O2|Outcome|Parent At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548229|NCT00145600|O1|Outcome|Patient At Diagnosis (T1)|Patients and parents were assessed for quality of life at Diagnosis (T1).
548230|NCT00145600|O4|Outcome|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
548231|NCT00145600|O3|Outcome|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
548232|NCT00145600|O2|Outcome|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
548233|NCT00145600|O1|Outcome|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
548234|NCT00145600|E4|Reported Event|Unfavorable Risk, Group 2|"Stage must be classified as one of the following:~a. Ann Arbor stage IIB, IIIB, or any IV"
548235|NCT00145600|E3|Reported Event|Unfavorable Risk, Group 1|Unfavorable risk group 1 closed early due to excessive number of adverse events (n=13).
548236|NCT00145600|E2|Reported Event|Intermediate Risk|"Stage must be classified as one of the following:~Ann Arbor stage IB and IIIA~Ann Arbor stage IA or IIA with ANY of the following features: (1) extranodal extension of disease lesion(s), (2) 3 or more nodal sites involved, (3) Bulky mediastinal adenopathy (mediastinal mass to thoracic cavity ratio 33% or greater by chest radiograph)"
548237|NCT00145600|E1|Reported Event|Favorable Risk|"Ann Arbor stage IA or IIA with:~Non-bulky mediastinal disease (<33% mediastinal to thoracic ratio on chest x-ray)~< 3 nodal regions involved on the same side of the diaphragm~No extranodal extension of disease"
548238|NCT00145587|B3|Baseline|Total|Total of all reporting groups
548239|NCT00145587|B2|Baseline|Sibling|Genetic testing
548240|NCT00145587|B1|Baseline|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
548241|NCT00145587|P2|Participant Flow|Sibling|Genetic testing
548242|NCT00145587|P1|Participant Flow|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
548243|NCT00145587|O2|Outcome|Sibling|Genetic testing
548244|NCT00145587|O1|Outcome|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
548245|NCT00145587|E2|Reported Event|Sibling|Genetic testing
548246|NCT00145587|E1|Reported Event|Haplo|Patients to receive a haploidentical hematopoietic stem cell transplantation (HSCT).
548247|NCT00145574|B4|Baseline|Total|Total of all reporting groups
548248|NCT00145574|B3|Baseline|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548249|NCT00145574|B2|Baseline|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548250|NCT00145574|B1|Baseline|Placebo|Placebo similar to active
548251|NCT00145574|P3|Participant Flow|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548252|NCT00145574|P2|Participant Flow|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548253|NCT00145574|P1|Participant Flow|Placebo|Placebo similar to active
548254|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548255|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548256|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548257|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548258|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548259|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548260|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548261|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
557275|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
548262|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548263|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548264|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548265|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548266|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548267|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548268|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548269|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548270|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548271|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548272|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548273|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548274|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548275|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548276|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548277|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548278|NCT00145574|O4|Outcome|All High Dose Colesevelam in Open Label Extension|Open Label Extension was an 18 week open-label treatment period. All participants were treated with 3750 mg colesevelam (high-dose).
548279|NCT00145574|O3|Outcome|High Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to high dose colesevelam 3.8 grams per day treatment during the Double blind Period.
548280|NCT00145574|O2|Outcome|Low Dose Colesevelam|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to low dose colesevelam 1.9 grams per day treatment during the Double blind Period.
548281|NCT00145574|O1|Outcome|Placebo|A subpopulation of the All High Dose treatment regimen of the Open Label Extension period of participants who were randomized to placebo treatment during the Double blind Period.
548282|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548283|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548284|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548285|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548286|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548287|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548288|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548289|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548290|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548291|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548292|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548293|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548294|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548295|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548296|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548297|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548298|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548299|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548300|NCT00145574|O3|Outcome|High Dose Colesevelam|High dose colesevelam 3.8 grams per day
548301|NCT00145574|O2|Outcome|Low Dose Colesevelam|Low dose colesevelam 1.9 grams per day
548302|NCT00145574|O1|Outcome|Placebo|Placebo similar to active
548303|NCT00145574|E4|Reported Event|High Dose Colesevelam Open Label Extension|All participants of the Open Label Extension (weeks 8-26) took colesevelam 3.8 grams per day.
548304|NCT00145574|E3|Reported Event|High Dose Colesevelam Double Blind Period|High dose colesevelam 3.8 grams per day taken from day 1 to week 8.
548305|NCT00145574|E2|Reported Event|Low Dose Colesevelam Double Blind Period|Low dose colesevelam 1.9 grams per day taken from day 1 to week 8.
548306|NCT00145574|E1|Reported Event|Placebo Double Blind Period|Placebo taken from day 1 to week 8.
548307|NCT00145509|B3|Baseline|Total|Total of all reporting groups
548308|NCT00145509|B2|Baseline|Placebo|Placebo sublingually BID
548309|NCT00145509|B1|Baseline|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548310|NCT00145509|P2|Participant Flow|Placebo|Placebo sublingually BID
548311|NCT00145509|P1|Participant Flow|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548312|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
548313|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548314|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
548315|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548316|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
548317|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548318|NCT00145509|O2|Outcome|Placebo|Placebo sublingually BID
548319|NCT00145509|O1|Outcome|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548320|NCT00145509|E2|Reported Event|Placebo|Placebo sublingually BID
548321|NCT00145509|E1|Reported Event|Asenapine|Asenapine 5 or 10 mg sublingually twice daily (BID)
548322|NCT00145496|B3|Baseline|Total|Total of all reporting groups
548323|NCT00145496|B2|Baseline|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548324|NCT00145496|B1|Baseline|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548325|NCT00145496|P2|Participant Flow|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548326|NCT00145496|P1|Participant Flow|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548327|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548328|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548329|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548330|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548331|NCT00145496|O2|Outcome|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548332|NCT00145496|O1|Outcome|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548333|NCT00145496|E2|Reported Event|Olanzapine|5-20 mg by mouth once daily for up to 26 weeks
548334|NCT00145496|E1|Reported Event|Asenapine|5-10 mg sublingually twice daily for up to 26 weeks
548335|NCT00145418|B1|Baseline|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548336|NCT00145418|P1|Participant Flow|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer. Oxaliplatin:85 mg/m2 on Days 1 and 15 every 28 days Docetaxel:30 mg/m2 on Days 1 and 8 every 28 days.Doses will be calculated using actual body weight unless in the investigators opinion it would be in the patient's best interest to use ideal body weight. Cycles will be repeated every 28 days for a maximum of 6 cycles.
548337|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548338|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548339|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548340|NCT00145418|O1|Outcome|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548341|NCT00145418|E1|Reported Event|Oxaliplatin + Docetaxel|Oxaliplatin + Docetaxel as first line therapy of Stage IV or IIIB unresectable non-small cell lung cancer
548342|NCT00145327|B4|Baseline|Total|Total of all reporting groups
548343|NCT00145327|B3|Baseline|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548344|NCT00145327|B2|Baseline|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548345|NCT00145327|B1|Baseline|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548346|NCT00145327|P3|Participant Flow|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548347|NCT00145327|P2|Participant Flow|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548348|NCT00145327|P1|Participant Flow|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548349|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548350|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548351|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
557412|NCT00114634|O1|Outcome|Placebo|egg substitute
548352|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548353|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548354|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548355|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548356|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548357|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548358|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548359|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548360|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548361|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548362|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548363|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548364|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548365|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548366|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548367|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548368|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548369|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548370|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548371|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548372|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548373|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548374|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548375|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548376|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548377|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548526|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548378|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548379|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548380|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548381|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548382|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548383|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548384|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548385|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548386|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548387|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548388|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548389|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548390|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548391|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548392|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548393|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548394|NCT00145327|O3|Outcome|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548395|NCT00145327|O2|Outcome|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548396|NCT00145327|O1|Outcome|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548397|NCT00145327|E3|Reported Event|Placebo 3 Zoledronic Acid 3|Patients who were treated with placebo for 3 years in the core study received 5 mg Zoledronic acid in a single intravenous infusion once a year for 3 years (at Months 36, 48 and 60) in this extension study.
548398|NCT00145327|E2|Reported Event|Zoledronic Acid 3 Placebo 3|Patients who were treated with Zoledronic acid for 3 years in the core study received a single intravenous matching Placebo infusion once a year for 3 years in this extension study.
548399|NCT00145327|E1|Reported Event|Zoledronic Acid 6|Patients who received Zoledronic acid for 3 years in the core study (CZOL446H2301; NCT00049829) received a single intravenous infusion of 5 mg Zoledronic acid once a year for 3 years (at Months 36, 48 and 60) in this extension study for a total of 6 years of treatment.
548400|NCT00145249|B4|Baseline|Total|Total of all reporting groups
548401|NCT00145249|B3|Baseline|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548402|NCT00145249|B2|Baseline|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548403|NCT00145249|B1|Baseline|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548404|NCT00145249|P3|Participant Flow|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548405|NCT00145249|P2|Participant Flow|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548406|NCT00145249|P1|Participant Flow|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548407|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548408|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548409|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548410|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548411|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548412|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548413|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548414|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548415|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548416|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548417|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548418|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548419|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548420|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548421|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548422|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548423|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548424|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548425|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548426|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548427|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548428|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548429|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548430|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548431|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548432|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548527|NCT00144339|O1|Outcome|Placebo|Once daily
548528|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548433|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548434|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548435|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548436|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548437|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548438|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548439|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548440|NCT00145249|O3|Outcome|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548441|NCT00145249|O2|Outcome|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548442|NCT00145249|O1|Outcome|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548443|NCT00145249|E3|Reported Event|AmphoB + Fluc800|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 800 mg/day for the first 14 days, then the randomized dose of fluconazole at 800 mg/day respectively for an additional 8 weeks.
548444|NCT00145249|E2|Reported Event|AmphoB+Fluc400|Amphotericin B 0.7 mg/kg and the randomized dose of fluconazole at 400 mg/day for the first 14 days, then the randomized dose of fluconazole at 400 mg/day respectively for an additional 8 weeks.
548445|NCT00145249|E1|Reported Event|AmphoB Standard|Amphotericin B 0.7 mg/kg for 14 day followed by fluconazole 400 mg daily for 8 weeks. For subjects in the standard therapy arm whose Amphotericin B dose is continued beyond 14 days, fluconazole initiation will be delayed.
548446|NCT00145119|B1|Baseline|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
548447|NCT00145119|P1|Participant Flow|Patients|
548448|NCT00145119|O1|Outcome|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction
548449|NCT00145119|E1|Reported Event|Patients|Survivors of an acute Myocardial Infarction (AMI) with impaired left ventricular ejection fraction.
548450|NCT00145041|B1|Baseline|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548451|NCT00145041|P1|Participant Flow|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548452|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548453|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548454|NCT00145041|O1|Outcome|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548455|NCT00145041|E1|Reported Event|Overall Study|This was a non-randomized, open-label, single arm, single-center Phase 1 study. All subjects received the same treatment. All subjects received Marqibo (VSLI) 1.0 mg/m2 delivered by intravenous infusion over 1 hour every 2 weeks.
548456|NCT00144963|B1|Baseline|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
548457|NCT00144963|P1|Participant Flow|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
548458|NCT00144963|O1|Outcome|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
548459|NCT00144963|E1|Reported Event|VSLI|Vincristine Sulfate Liposomes Injection (VSLI)
548460|NCT00144781|B5|Baseline|Total|Total of all reporting groups
548461|NCT00144781|B4|Baseline|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548462|NCT00144781|B3|Baseline|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548463|NCT00144781|B2|Baseline|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
548464|NCT00144781|B1|Baseline|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
548465|NCT00144781|P4|Participant Flow|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548529|NCT00144339|O1|Outcome|Placebo|Once daily
548530|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548466|NCT00144781|P3|Participant Flow|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548467|NCT00144781|P2|Participant Flow|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
548468|NCT00144781|P1|Participant Flow|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
548469|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548470|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548471|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
548472|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
548473|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548474|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548475|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
548476|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
548477|NCT00144781|O4|Outcome|1.8 mg/kg Aldurazyme Every 2 Weeks|1.8 mg Aldurazyme/kg of body weight (300 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548478|NCT00144781|O3|Outcome|1.2 mg/kg Aldurazyme Every 2 Weeks|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every 2 weeks. Final Visit is Week 26 for patients randomized to every 2 week regimen.
548479|NCT00144781|O2|Outcome|1.2 mg/kg Aldurazyme Every Week|1.2 mg Aldurazyme/kg of body weight (200 U/kg) administered every week. Final Visit is Week 27 for patients randomized to every week regimen.
548480|NCT00144781|O1|Outcome|0.58 mg/kg Aldurazyme Every Week|0.58 mg Aldurazyme/kg of body weight (100 U/kg) administered every week (labeled dose). Final Visit is Week 27 for patients randomized to every week regimen.
548481|NCT00144781|E4|Reported Event|"Aldurazyme|Weekly|1.2 mg/kg***Check Title***"|"Aldurazyme|Weekly|1.2 mg/kg***Check Description***"
548482|NCT00144781|E3|Reported Event|"Aldurazyme|Weekly|0.58 mg/kg***Check Title***"|"Aldurazyme|Weekly|0.58 mg/kg***Check Description***"
548483|NCT00144781|E2|Reported Event|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.8 mg/kg***Check Description***"
548484|NCT00144781|E1|Reported Event|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Title***"|"Aldurazyme|Every Other|Week 1.2 mg/kg***Check Description***"
548485|NCT00144339|B3|Baseline|Total|Total of all reporting groups
548486|NCT00144339|B2|Baseline|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548487|NCT00144339|B1|Baseline|Placebo|Once daily
548488|NCT00144339|P2|Participant Flow|Tiotropium Bromide Inhalation Capsules 18 mcg|once daily
548489|NCT00144339|P1|Participant Flow|Placebo|once daily
548490|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548491|NCT00144339|O1|Outcome|Placebo|Once daily
548492|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548493|NCT00144339|O1|Outcome|Placebo|Once daily
548494|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548495|NCT00144339|O1|Outcome|Placebo|Once daily
548496|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548497|NCT00144339|O1|Outcome|Placebo|Once daily
548498|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548499|NCT00144339|O1|Outcome|Placebo|Once daily
548500|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548501|NCT00144339|O1|Outcome|Placebo|Once daily
548502|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548503|NCT00144339|O1|Outcome|Placebo|Once daily
548504|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548505|NCT00144339|O1|Outcome|Placebo|Once daily
548506|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548507|NCT00144339|O1|Outcome|Placebo|Once daily
548508|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548509|NCT00144339|O1|Outcome|Placebo|Once daily
548510|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548511|NCT00144339|O1|Outcome|Placebo|Once daily
548512|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548513|NCT00144339|O1|Outcome|Placebo|Once daily
548514|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548515|NCT00144339|O1|Outcome|Placebo|Once daily
548516|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548517|NCT00144339|O1|Outcome|Placebo|Once daily
548518|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548519|NCT00144339|O1|Outcome|Placebo|Once daily
548520|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548521|NCT00144339|O1|Outcome|Placebo|Once daily
548522|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548523|NCT00144339|O1|Outcome|Placebo|Once daily
548532|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548533|NCT00144339|O1|Outcome|Placebo|Once daily
548534|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548535|NCT00144339|O1|Outcome|Placebo|Once daily
548536|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548537|NCT00144339|O1|Outcome|Placebo|Once daily
548538|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548539|NCT00144339|O1|Outcome|Placebo|Once daily
548540|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548541|NCT00144339|O1|Outcome|Placebo|Once daily
548542|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548543|NCT00144339|O1|Outcome|Placebo|Once daily
548544|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548545|NCT00144339|O1|Outcome|Placebo|Once daily
548546|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548547|NCT00144339|O1|Outcome|Placebo|Once daily
548548|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548549|NCT00144339|O1|Outcome|Placebo|Once daily
548550|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548551|NCT00144339|O1|Outcome|Placebo|Once daily
548552|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548553|NCT00144339|O1|Outcome|Placebo|Once daily
548554|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548555|NCT00144339|O1|Outcome|Placebo|Once daily
548556|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548557|NCT00144339|O1|Outcome|Placebo|Once daily
548558|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548559|NCT00144339|O1|Outcome|Placebo|Once daily
548560|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548561|NCT00144339|O1|Outcome|Placebo|Once daily
548562|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548563|NCT00144339|O1|Outcome|Placebo|Once daily
548564|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548565|NCT00144339|O1|Outcome|Placebo|Once daily
548566|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548567|NCT00144339|O1|Outcome|Placebo|Once daily
548568|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548569|NCT00144339|O1|Outcome|Placebo|Once daily
548570|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548571|NCT00144339|O1|Outcome|Placebo|Once daily
548572|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548573|NCT00144339|O1|Outcome|Placebo|Once daily
548574|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548575|NCT00144339|O1|Outcome|Placebo|Once daily
548576|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548577|NCT00144339|O1|Outcome|Placebo|Once daily
548578|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548579|NCT00144339|O1|Outcome|Placebo|Once daily
548580|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548581|NCT00144339|O1|Outcome|Placebo|Once daily
548582|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548583|NCT00144339|O1|Outcome|Placebo|Once daily
548584|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548585|NCT00144339|O1|Outcome|Placebo|Once daily
548586|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548587|NCT00144339|O1|Outcome|Placebo|Once daily
548588|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548589|NCT00144339|O1|Outcome|Placebo|Once daily
548590|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548591|NCT00144339|O1|Outcome|Placebo|Once daily
548592|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548593|NCT00144339|O1|Outcome|Placebo|Once daily
548594|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548595|NCT00144339|O1|Outcome|Placebo|Once daily
548596|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548597|NCT00144339|O1|Outcome|Placebo|Once daily
548598|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548599|NCT00144339|O1|Outcome|Placebo|Once daily
548600|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548601|NCT00144339|O1|Outcome|Placebo|Once daily
548602|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548603|NCT00144339|O1|Outcome|Placebo|Once daily
548604|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548605|NCT00144339|O1|Outcome|Placebo|Once daily
548606|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548607|NCT00144339|O1|Outcome|Placebo|Once daily
548608|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548609|NCT00144339|O1|Outcome|Placebo|Once daily
548610|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548611|NCT00144339|O1|Outcome|Placebo|Once daily
548612|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548613|NCT00144339|O1|Outcome|Placebo|Once daily
548614|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548615|NCT00144339|O1|Outcome|Placebo|Once daily
557413|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
548616|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548617|NCT00144339|O1|Outcome|Placebo|Once daily
548618|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548619|NCT00144339|O1|Outcome|Placebo|Once daily
548620|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548621|NCT00144339|O1|Outcome|Placebo|Once daily
548622|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548623|NCT00144339|O1|Outcome|Placebo|Once daily
548624|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548625|NCT00144339|O1|Outcome|Placebo|Once daily
548626|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548627|NCT00144339|O1|Outcome|Placebo|Once daily
548628|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548629|NCT00144339|O1|Outcome|Placebo|Once daily
548630|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548631|NCT00144339|O1|Outcome|Placebo|Once daily
548632|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548633|NCT00144339|O1|Outcome|Placebo|Once daily
548634|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548635|NCT00144339|O1|Outcome|Placebo|Once daily
548636|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548637|NCT00144339|O1|Outcome|Placebo|Once daily
548638|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548639|NCT00144339|O1|Outcome|Placebo|Once daily
548640|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548641|NCT00144339|O1|Outcome|Placebo|Once daily
548642|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548643|NCT00144339|O1|Outcome|Placebo|Once daily
548644|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548645|NCT00144339|O1|Outcome|Placebo|Once daily
548646|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548647|NCT00144339|O1|Outcome|Placebo|Once daily
548648|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548649|NCT00144339|O1|Outcome|Placebo|Once daily
548650|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548651|NCT00144339|O1|Outcome|Placebo|Once daily
548652|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548653|NCT00144339|O1|Outcome|Placebo|Once daily
548654|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548655|NCT00144339|O1|Outcome|Placebo|Once daily
548656|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548657|NCT00144339|O1|Outcome|Placebo|Once daily
548658|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548659|NCT00144339|O1|Outcome|Placebo|Once daily
548660|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548661|NCT00144339|O1|Outcome|Placebo|Once daily
548662|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548663|NCT00144339|O1|Outcome|Placebo|Once daily
548664|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548665|NCT00144339|O1|Outcome|Placebo|Once daily
548666|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548667|NCT00144339|O1|Outcome|Placebo|Once daily
548668|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548669|NCT00144339|O1|Outcome|Placebo|Once daily
548670|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548671|NCT00144339|O1|Outcome|Placebo|Once daily
548672|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548673|NCT00144339|O1|Outcome|Placebo|Once daily
548674|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548675|NCT00144339|O1|Outcome|Placebo|Once daily
548676|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548677|NCT00144339|O1|Outcome|Placebo|Once daily
548678|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548679|NCT00144339|O1|Outcome|Placebo|Once daily
548680|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548681|NCT00144339|O1|Outcome|Placebo|Once daily
548682|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548683|NCT00144339|O1|Outcome|Placebo|Once daily
548684|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548685|NCT00144339|O1|Outcome|Placebo|Once daily
548686|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548687|NCT00144339|O1|Outcome|Placebo|Once daily
548688|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548689|NCT00144339|O1|Outcome|Placebo|Once daily
548690|NCT00144339|O2|Outcome|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548691|NCT00144339|O1|Outcome|Placebo|Once daily
548692|NCT00144339|E2|Reported Event|Tiotropium Bromide Inhalation Capsules 18 mcg|Once daily
548693|NCT00144339|E1|Reported Event|Placebo|Once daily
548694|NCT00144300|B3|Baseline|Total|Total of all reporting groups
548695|NCT00144300|B2|Baseline|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548696|NCT00144300|B1|Baseline|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548697|NCT00144300|P2|Participant Flow|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548698|NCT00144300|P1|Participant Flow|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548699|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548700|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548701|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548702|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548703|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548704|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548705|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548706|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548707|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548708|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548709|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548710|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548711|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548712|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548713|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548714|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548715|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548716|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548717|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548718|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548719|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548720|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548721|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548722|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548723|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548724|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548725|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548726|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548727|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548728|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548729|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548730|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548731|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548732|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548733|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548734|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548735|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548736|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548737|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548738|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548739|NCT00144300|O2|Outcome|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548740|NCT00144300|O1|Outcome|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548741|NCT00144300|E2|Reported Event|Ropinirole|Flexible: 0.25 mg 3 times daily up to maximum tolerated
548742|NCT00144300|E1|Reported Event|Pramipexole|Flexible: 0.125 mg 3 times daily up to maximum tolerated
548743|NCT00144170|B3|Baseline|Total|Total of all reporting groups
548744|NCT00144170|B2|Baseline|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548745|NCT00144170|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548746|NCT00144170|P2|Participant Flow|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548747|NCT00144170|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548748|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548749|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548750|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548751|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548752|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548753|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548754|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548755|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548756|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548757|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548758|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548759|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548760|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548761|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548762|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548763|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548764|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548765|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548766|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548768|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548769|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548770|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548771|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548772|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548773|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548774|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548775|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548776|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548777|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548778|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548779|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548780|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548781|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548782|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548783|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548784|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548785|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548786|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548787|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548788|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548789|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548790|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548791|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548792|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548793|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548794|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548795|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548796|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548797|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548798|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548799|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548800|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548801|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548802|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548803|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548804|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548805|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548806|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548807|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548808|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548809|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548810|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548811|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548812|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548813|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548814|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548815|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548816|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548817|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548818|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548819|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548820|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548821|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548822|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548823|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548824|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548825|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548826|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548827|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548828|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548829|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548830|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548831|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548832|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548833|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548834|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548835|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548836|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548837|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548838|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548839|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548840|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548841|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548842|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548844|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548845|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548846|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548847|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548848|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548849|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548850|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548851|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548852|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548853|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548854|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548855|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548856|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548857|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548858|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548859|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548860|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548861|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548862|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548863|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548864|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548865|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548866|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548867|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548868|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548869|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548870|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548871|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548872|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548873|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548874|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548875|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548876|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548877|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548878|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548879|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548880|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548881|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548882|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548883|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548884|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548885|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548886|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548887|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548888|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548889|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548890|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548891|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548892|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548893|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548894|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548895|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548896|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548897|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548898|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548899|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548900|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548901|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548902|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548903|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548904|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548905|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548906|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548907|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548908|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548909|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548910|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548911|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548912|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548913|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548914|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548915|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548916|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548917|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548918|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548920|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548921|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548922|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548923|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548924|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548925|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548926|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548927|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548928|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548929|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548930|NCT00144170|O2|Outcome|Comparator Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548931|NCT00144170|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548932|NCT00144170|E2|Reported Event|Comparitor Protease Inhibitor(CPI)/Low Dose Ritonavir(r)|
548933|NCT00144170|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|
548934|NCT00144027|B3|Baseline|Total|Total of all reporting groups
548935|NCT00144027|B2|Baseline|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
548936|NCT00144027|B1|Baseline|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
548937|NCT00144027|P2|Participant Flow|Antipsychotic Adherence Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
548938|NCT00144027|P1|Participant Flow|Control|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
548939|NCT00144027|O2|Outcome|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
548940|NCT00144027|O1|Outcome|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
548941|NCT00144027|E2|Reported Event|Intervention Group|Antipsychotic medication adherence intervention: The medication adherence intervention will include using a computer to complete a brief set of questions related to medication adherence before mental health clinic visits. The patient will receive a hard copy summary of their responses (top 3 barriers and top 3 facilitators and motivators) with brief adherence tips which are specific to the patient-selected barriers. The provider will received the same information in an electronic health record adherence note.
548942|NCT00144027|E1|Reported Event|Control/No Intervention|The control group will receive treatment as usual; meaning patients in the control group will not receive the medication adherence intervention.
548943|NCT00143845|B1|Baseline|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
548944|NCT00143845|P1|Participant Flow|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
548945|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
548946|NCT00143845|O1|Outcome|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
548947|NCT00143845|E1|Reported Event|Immunosuppression Taper|Reduced intensity conditioning consisting of Busulfan and Fludarabine(fludarabine 150 mg/m2 IV, busulfan 6 mg/kg IV, total lymphoid irradiation 2 Gy), followed by a rapid immunosuppressive taper of Tacrolimus (0.06 mg/kg q12h, PO, Days -7 to +28), Methotrexate (5 mg/m2, IV, Days +1, +3, +6, +11) and Mycophenolate Mofetil (10 mg/kg every 8 hours, PO, Days -6 to +7).
548948|NCT00142935|B4|Baseline|Total|Total of all reporting groups
548949|NCT00142935|B3|Baseline|MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
548950|NCT00142935|B2|Baseline|MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
549022|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
548951|NCT00142935|B1|Baseline|Pre-release MMT Initiation + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
548952|NCT00142935|P3|Participant Flow|MMT Referral Post Release|Participants assigned to this arm will not begin treatment prior to release from incarceration or have treatment paid for by the study. However, study staff will work with participants to identify ways to pay for treatment, including assisting with Medicaid applications, etc. Further, the study will make the logistical arrangements for entering treatment if participant has a means to finance MMT.
548953|NCT00142935|P2|Participant Flow|MMT Referral Post Release + Payment|Participants assigned to this arm will have all logistical arrangements made for entry into a community methadone clinic program within 24-48 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
548954|NCT00142935|P1|Participant Flow|Pre-release MMT Initiation + Referral Post Release + Payment|Participants assigned to this arm will undergo extensive assessment (physical, medical history, drug use and treatment history) prior to initiating treatment. MMT will begin 1-30 days prior to release from incarceration. MMT first dose will begin at 5 mg with 2 mg increase per day until release or therapeutic dose of 60-120 mg is achieved. Daily observation by dosing nurses and twice weekly symptom review by Research Assistant will occur. Additionally, participants assigned to Arm 1 will have all logistical arrangements made for entry into a community methadone clinic program within 24 hours of release from incarceration. The study will fully pay for MMT for 12 weeks and half the costs of treatment for the next 12 weeks.
548955|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
548956|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
548957|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
548958|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
548959|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
548960|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
548961|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
548962|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
548963|NCT00142935|O1|Outcome|As Assigned: MMT Pre-release + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
548964|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.
548965|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.
548966|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.
548967|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
548968|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
548969|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
548970|NCT00142935|O3|Outcome|As Assigned: MMT Referral Post Release|Participants enrolled in Group 3 will be referred to a methadone program of their choice upon release from incarceration without receiving financial assistance.
548971|NCT00142935|O2|Outcome|As Assigned: MMT Referral Post Release + Payment|Participants enrolled in Group 2 will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
548972|NCT00142935|O1|Outcome|As Assigned: Pre-release MMT + Referral Post Release + Payment|Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will be linked to a methadone treatment program of their choice upon release from incarceration with provision of short-term payment of treatment costs.
549023|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549024|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
548973|NCT00142935|E3|Reported Event|As Assigned: MMT Referral Post Release|"Participants enrolled in Group 3 will be referred to a program of their choice upon release from incarceration without receiving financial assistance.~Fatal overdose deaths are calculated using all participants assigned to Arm 3. Other adverse events are calculated using self reported data from 12 month interviews."
548974|NCT00142935|E2|Reported Event|As Assigned: MMT Referral Post Release + Payment|"Participants enrolled in Group 2 will be referred to a methadone program of choice upon release from incarceration with provision of short-term payment of treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 2. Other adverse events are calculated using self reported data from 12 month interviews."
548975|NCT00142935|E1|Reported Event|As Assigned: Pre-release MMT + Referral Post Release + Payment|"Participants enrolled in Group 1 will initiate methadone opiate replacement therapy about 1 month prior to release from incarceration. They will then proceed with a methadone program of choice upon release and receive short-term payment to cover treatment costs.~Fatal overdose deaths are calculated using all participants assigned to Arm 1. Other adverse events are calculated using self reported data from 12 month interviews."
548976|NCT00142909|B3|Baseline|Total|Total of all reporting groups
548977|NCT00142909|B2|Baseline|Placebo|
548978|NCT00142909|B1|Baseline|Lofexidine|
548979|NCT00142909|P2|Participant Flow|Placebo|Participants will receive daily placebo and follow the same schedule as the active intervention for 12 weeks.
548980|NCT00142909|P1|Participant Flow|Lofexidine|"Lofexidine: Study medication~Participants will receive daily lofexidine and the dosing will be initiated at 0.4 mg bid and increased to 0.8mg in week 1 and 1.0 and 1.2 mg bid in week 2, and maintained at 1.2mg bid for weeks 3 to 12. They are then tapered down to 0 over the course of four days in week 12. While the target dose will be 2.4 mg daily, if any subject shows reduced tolerability at this or a lower dose, the dose will be adjusted to the maximum tolerated dose for that subject."
548981|NCT00142909|O2|Outcome|Placebo|Placebo pill
548982|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548983|NCT00142909|O2|Outcome|Placebo|Placebo pill
548984|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548985|NCT00142909|O2|Outcome|Placebo|Placebo pill
548986|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548987|NCT00142909|O2|Outcome|Placebo|Placebo pill
548988|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548989|NCT00142909|O2|Outcome|Placebo|Placebo pill
548990|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548991|NCT00142909|O2|Outcome|Placebo|Placebo pill
548992|NCT00142909|O1|Outcome|Lofexidine|Lofexidine: Study medication
548993|NCT00142909|E2|Reported Event|Placebo|Placebo pill
548994|NCT00142909|E1|Reported Event|Lofexidine|Lofexidine: Study medication
548995|NCT00143598|B3|Baseline|Total|Total of all reporting groups
548996|NCT00143598|B2|Baseline|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
548997|NCT00143598|B1|Baseline|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
548998|NCT00143598|P2|Participant Flow|Placebo ECS|Placebo stockings with identical appearance but less than 5 mm Hg compression at the ankle.
548999|NCT00143598|P1|Participant Flow|Active ECS|Active Elastic Compression Stockings. 30-40 mm Hg
549000|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
549001|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
549002|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
549003|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
549004|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
549005|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
549006|NCT00143598|O2|Outcome|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
549007|NCT00143598|O1|Outcome|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
549008|NCT00143598|E2|Reported Event|Placebo ECS|Placebo stockings with identical appearance to Active ECS and with < 5 mm Hg compression at the ankle.
549009|NCT00143598|E1|Reported Event|Active ECS|Active Elastic Compression Stockings (ECS) 30-40 mm Hg compression at the ankle.
549010|NCT00143507|B3|Baseline|Total|Total of all reporting groups
549011|NCT00143507|B2|Baseline|Placebo|Patients received placebo twice daily.
549012|NCT00143507|B1|Baseline|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549013|NCT00143507|P2|Participant Flow|Placebo|Patients received placebo twice daily.
549014|NCT00143507|P1|Participant Flow|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549015|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549016|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549017|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549018|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549019|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549020|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549021|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549025|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549026|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549027|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549028|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549029|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549030|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549031|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549032|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549033|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549034|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549035|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549036|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549037|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549038|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549039|NCT00143507|O2|Outcome|Placebo|Patients received placebo twice daily.
549040|NCT00143507|O1|Outcome|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549041|NCT00143507|E2|Reported Event|Placebo|Patients received placebo twice daily.
549042|NCT00143507|E1|Reported Event|Ivabradine|Patients received ivabradine at starting dose of 5 mg twice daily, with a target dose, if HR tolerance criteria were met after two weeks (at the D15 visit), of 7.5 mg twice daily.
549043|NCT00143455|B5|Baseline|Total|Total of all reporting groups
549044|NCT00143455|B4|Baseline|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549045|NCT00143455|B3|Baseline|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549046|NCT00143455|B2|Baseline|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549047|NCT00143455|B1|Baseline|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549048|NCT00143455|P4|Participant Flow|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549049|NCT00143455|P3|Participant Flow|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549050|NCT00143455|P2|Participant Flow|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549051|NCT00143455|P1|Participant Flow|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549052|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549053|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549054|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549055|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549056|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549284|NCT00141778|B2|Baseline|Ramipril|Angiotensin-converting enzyme inhibitor group
549285|NCT00141778|B1|Baseline|Placebo|Placebo Group
549057|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549058|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549059|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549060|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549061|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549062|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549063|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549064|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549065|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549066|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549067|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549068|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549069|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549070|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549071|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549072|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549073|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549074|NCT00143455|O4|Outcome|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549075|NCT00143455|O3|Outcome|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549076|NCT00143455|O2|Outcome|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549077|NCT00143455|O1|Outcome|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549078|NCT00143455|E4|Reported Event|Etoposide + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549231|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549079|NCT00143455|E3|Reported Event|Irinotecan + Cisplatin (Cohort 2)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 65 mg/m2 administered intravenously (IV) over 30 - 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549080|NCT00143455|E2|Reported Event|Etoposide + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of: Etoposide 100 mg/m2 administered intravenously (IV) on Day 1, Day 2 and Day 3 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549081|NCT00143455|E1|Reported Event|Irinotecan + Cisplatin (Cohort 1)|Each chemotherapy cycle was repeated every 21 days (3 weeks) and consisted of : Irinotecan hydrochloride 80 mg/m2 administered intravenously (IV) over 30 – 90 minutes on Day 1 and Day 8 followed by cisplatin 80 mg/m2 administered intravenously (IV) over 30-60 minutes on Day 1.
549082|NCT00143403|B3|Baseline|Total|Total of all reporting groups
549083|NCT00143403|B2|Baseline|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549084|NCT00143403|B1|Baseline|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549085|NCT00143403|P2|Participant Flow|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549086|NCT00143403|P1|Participant Flow|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549087|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549088|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549089|NCT00143403|O2|Outcome|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549090|NCT00143403|O1|Outcome|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549091|NCT00143403|E2|Reported Event|Irinotecan + 5-FU/FA|irinotecan plus simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549092|NCT00143403|E1|Reported Event|5-FU/FA|simplified 5-FU/FA De Gramont regimen for a period of twelve 2-week cycles (6 months)
549093|NCT00143390|B3|Baseline|Total|Total of all reporting groups
549094|NCT00143390|B2|Baseline|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549095|NCT00143390|B1|Baseline|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549096|NCT00143390|P2|Participant Flow|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549097|NCT00143390|P1|Participant Flow|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549098|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549099|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549100|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549101|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549102|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549103|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549104|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549105|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549106|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549107|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549108|NCT00143390|O2|Outcome|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549109|NCT00143390|O1|Outcome|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549110|NCT00143390|E2|Reported Event|Anastrozole|One tablet each of anastrozole 1 mg and exemestane placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549544|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
549111|NCT00143390|E1|Reported Event|Exemestane|One tablet each of exemestane 25 mg and anastrozole placebo were orally administered once daily after a meal. The study treatment was continued until the disease progression or other discontinuation criteria were met.
549112|NCT00143312|B1|Baseline|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549113|NCT00143312|P1|Participant Flow|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549114|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549115|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549116|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549117|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549118|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549119|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549120|NCT00143312|O1|Outcome|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549121|NCT00143312|E1|Reported Event|Voriconazole|All subjects received voriconazole as study medication for prophylaxis, for a minimum of 100 days after transplant. Subjects received an intravenous (IV; 6 mg/kg)) or oral (PO; 400 mg) loading dose every 12 hours (q12h) for 2 doses, followed by maintenance (i.e., prophylactic) doses of 4 mg/kg IV q12h or 200 mg PO q12h, if the subject weighed ≥40 kg. If the subject weighed <40 kg, the PO loading dose was 200 mg PO q12h for 2 doses, followed by maintenance doses of 100 mg PO q12h.
549122|NCT00143247|B1|Baseline|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549123|NCT00143247|P1|Participant Flow|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549124|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549125|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549126|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549545|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549127|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549128|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549129|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549130|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549131|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549132|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549133|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549134|NCT00143247|O1|Outcome|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549135|NCT00143247|E1|Reported Event|Inhaled Insulin|Open label EXUBERA® (EXU; inhaled insulin), no comparator. At all times in the trial, each subject had an individualized recommended insulin dose for each of the dosing times. Initial recommended doses for EXU were based on the subject’s weight, any previous responses to insulin, and other factors noted in the protocol.
549136|NCT00142818|B5|Baseline|Total|Total of all reporting groups
549137|NCT00142818|B4|Baseline|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
549138|NCT00142818|B3|Baseline|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
549139|NCT00142818|B2|Baseline|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
549140|NCT00142818|B1|Baseline|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
549141|NCT00142818|P4|Participant Flow|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
549142|NCT00142818|P3|Participant Flow|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
549143|NCT00142818|P2|Participant Flow|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
549144|NCT00142818|P1|Participant Flow|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
549145|NCT00142818|O4|Outcome|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
549146|NCT00142818|O3|Outcome|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
549147|NCT00142818|O2|Outcome|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
549148|NCT00142818|O1|Outcome|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
549149|NCT00142818|E4|Reported Event|Double Placebo|"Placebo~Placebo: 400 mg and/or 100-150 mg placebo pills"
549150|NCT00142818|E3|Reported Event|Modafinil and Placebo|"Mod~Modafinil: 400 mg daily"
549151|NCT00142818|E2|Reported Event|Naltrexone and Placebo|"Nal~Naltrexone: 150 mg daily for males; 100 mg daily for females"
549152|NCT00142818|E1|Reported Event|ModNal|"Nal + Mod~Naltrexone: 150 mg daily for males; 100 mg daily for females~Modafinil: 400 mg daily"
549153|NCT00142597|B3|Baseline|Total|Total of all reporting groups
549154|NCT00142597|B2|Baseline|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549155|NCT00142597|B1|Baseline|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549156|NCT00142597|P2|Participant Flow|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549157|NCT00142597|P1|Participant Flow|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549158|NCT00142597|O2|Outcome|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549159|NCT00142597|O1|Outcome|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549160|NCT00142597|E2|Reported Event|Sham Treatment|"Sham acupuncture is used.~Sham treatment: Fibromyalgia participants will be randomized to receive 9 sham treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549161|NCT00142597|E1|Reported Event|Traditional Acupuncture|"Acupuncture sites will be used for active intervention.~Acupuncture: Involves the insertion and manual stimulation of thin acupuncture needles into specific points in the body.~Fibromyalgia participants will be randomized to receive 9 acupuncture treatments over the course of four weeks.~All participants will be scanned twice using the fMRI scanner. The PET portion of the study is optional."
549162|NCT00142298|B11|Baseline|Total|Total of all reporting groups
549163|NCT00142298|B10|Baseline|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549164|NCT00142298|B9|Baseline|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549165|NCT00142298|B8|Baseline|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549166|NCT00142298|B7|Baseline|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549167|NCT00142298|B6|Baseline|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549168|NCT00142298|B5|Baseline|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549169|NCT00142298|B4|Baseline|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549170|NCT00142298|B3|Baseline|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549171|NCT00142298|B2|Baseline|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549172|NCT00142298|B1|Baseline|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549173|NCT00142298|P10|Participant Flow|Group C: Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549174|NCT00142298|P9|Participant Flow|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549175|NCT00142298|P8|Participant Flow|Group C: LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549176|NCT00142298|P7|Participant Flow|Group B: LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549177|NCT00142298|P6|Participant Flow|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549232|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549178|NCT00142298|P5|Participant Flow|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549179|NCT00142298|P4|Participant Flow|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549180|NCT00142298|P3|Participant Flow|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549181|NCT00142298|P2|Participant Flow|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549182|NCT00142298|P1|Participant Flow|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549183|NCT00142298|O1|Outcome|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549184|NCT00142298|O2|Outcome|Group C: LAM Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549185|NCT00142298|O1|Outcome|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549186|NCT00142298|O1|Outcome|Group B : LAM 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549187|NCT00142298|O1|Outcome|Group B : LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549188|NCT00142298|O3|Outcome|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549189|NCT00142298|O2|Outcome|Group A: Feeder Study 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549190|NCT00142298|O1|Outcome|Group A: Feeder Study 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549191|NCT00142298|O1|Outcome|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549192|NCT00142298|O1|Outcome|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549193|NCT00142298|E10|Reported Event|Group C : Other Feeder Studies|Patients with either compensated or decompensated chronic hepatitis B, from 2401 (NCT00115245), 2402 (NCT00132652) and 010 (NCT00124241). Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549194|NCT00142298|E9|Reported Event|Group C: Lam Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549195|NCT00142298|E8|Reported Event|Group C : LdT Pool 2302/015|Subjects with either compensated or decompensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive any study drug except in case of patients who relapsed and reinitiated treatment.
549196|NCT00142298|E7|Reported Event|Group B: Lam 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration studies 2301 (NCT00076336) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549197|NCT00142298|E6|Reported Event|Group B: LdT 2301|Subjects with HBeAg (+) or HBeAg (-) decompensated chronic hepatitis B from phase III pivotal, registration study 2301 (NCT00076336) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549198|NCT00142298|E5|Reported Event|Group A: Feeder 2402|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2402 (NCT00132652) and treated with Lamivudine or Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549199|NCT00142298|E4|Reported Event|Group A: Feeder 2401|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase IIIb, registration study CLDT600A2401 (NCT00115245) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549200|NCT00142298|E3|Reported Event|Group A: Feeder Study 010|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B were from phase IIb study NV-02B-010 (NCT00124241) of telbivudine, lamivudine or the combination of both agents. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549201|NCT00142298|E2|Reported Event|Group A : LAM Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Lamivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks.
549202|NCT00142298|E1|Reported Event|Group A : LdT Pool 2302/015|Subjects with HBeAg (+) or HBeAg (-) compensated chronic hepatitis B from phase III pivotal, registration studies 2302 (NCT00057265) and 015 (NCT00131742) treated with Telbivudine. Telbivudine 600 mg by mouth (p.o.) daily for 104 weeks. The total telbivudine treatment time starting from feeder study baseline to the end of the on-treatment period in study 2303 was 208 weeks.
549203|NCT00142168|B1|Baseline|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549204|NCT00142168|P1|Participant Flow|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549205|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549206|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549207|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549208|NCT00142168|O1|Outcome|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549209|NCT00142168|E1|Reported Event|Lenalidomide and Rituximab|Intended therapy consisted of 48 weeks of lenalidomide (25 mg/d for 3 weeks and then 1 week off) along with rituximab (375 mg/m(2)/wk) dosed on weeks 2 to 5 and 13 to 16.
549210|NCT00142116|B1|Baseline|All WM Patients|Waldenstrom's Macroglobulinemia Patients
549211|NCT00142116|P1|Participant Flow|All WM Patients|Waldenstrom's Macroglobulinemia Patients
549212|NCT00142116|O1|Outcome|Thalidomide and Rituximab|"Thalidomide 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks~Rituximab Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later.~Thalidomide: 200mg orally once a day for 14 weeks if that dosage is tolerated well, it will be increased to 400mg for up to 50 weeks.~Rituximab: Given intravenously once weekly for 4 weeks beginning the second week of study treatment. If tolerated well, this may be repeated 8 weeks later."
549213|NCT00142116|O1|Outcome|All WM Patients|Waldenstrom's Macroglobulinemia Patients
549214|NCT00142116|E1|Reported Event|All WM Patients|Waldenstrom's Macroglobulinemia Patients
549215|NCT00141921|B1|Baseline|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549216|NCT00141921|P1|Participant Flow|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549217|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549218|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549219|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549220|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549221|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549222|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549223|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549224|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549225|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549226|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549227|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549228|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549229|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549230|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549233|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549234|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549235|NCT00141921|O1|Outcome|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549236|NCT00141921|E1|Reported Event|Etanercept|Participants received etanercept 0.8 mg/kg (up to a maximum dose of 50 mg) once weekly by subcutaneous injection for up to 264 weeks.
549237|NCT00141817|B5|Baseline|Total|Total of all reporting groups
549238|NCT00141817|B4|Baseline|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549239|NCT00141817|B3|Baseline|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549240|NCT00141817|B2|Baseline|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549241|NCT00141817|B1|Baseline|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549242|NCT00141817|P4|Participant Flow|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549243|NCT00141817|P3|Participant Flow|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549244|NCT00141817|P2|Participant Flow|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549245|NCT00141817|P1|Participant Flow|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549246|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549247|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549248|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549249|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549250|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549251|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549252|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549253|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549254|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549255|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549256|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549257|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549258|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549259|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549260|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549261|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549262|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549263|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549264|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549265|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549266|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549267|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549268|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549269|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549270|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549271|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549272|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549273|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549274|NCT00141817|O4|Outcome|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549275|NCT00141817|O3|Outcome|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549276|NCT00141817|O2|Outcome|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549277|NCT00141817|O1|Outcome|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549278|NCT00141817|E4|Reported Event|Pantoprazole 1.2 mg/kg Tablets|Pantoprazole 1.2 mg/kg Tablets for Participants Aged >=6 years
549279|NCT00141817|E3|Reported Event|Pantoprazole 0.6 mg/kg Tablets|Pantoprazole 0.6 mg/kg Tablets for Participants Aged >=6 years
549280|NCT00141817|E2|Reported Event|Pantoprazole 1.2 mg/kg Spheroids|Pantoprazole 1.2 mg/kg Spheroids for Participants Aged <6 years
549281|NCT00141817|E1|Reported Event|Pantoprazole 0.6 mg/kg Spheroids|Pantoprazole 0.6 mg/kg Spheroids for Participants Aged <6 years
549282|NCT00141778|B4|Baseline|Total|Total of all reporting groups
549283|NCT00141778|B3|Baseline|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549286|NCT00141778|P3|Participant Flow|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist Group.Spironolactone was given as 25 mg/day.
549287|NCT00141778|P2|Participant Flow|Ramipril|Angiotensin-Converting Enzyme Inhibitor Group. Ramipril was given as 2.5 mg the first 3 days followed by 5 mg/day, with the dose reduced to 2.5 mg/day on the first postoperative day only.
549288|NCT00141778|P1|Participant Flow|Placebo|Placebo Group
549289|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549290|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549291|NCT00141778|O1|Outcome|Placebo|Placebo Group
549292|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549293|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549294|NCT00141778|O1|Outcome|Placebo|Placebo Group
549295|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549296|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549297|NCT00141778|O1|Outcome|Placebo|Placebo Group
549298|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549299|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549300|NCT00141778|O1|Outcome|Placebo|Placebo Group
549301|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549302|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549303|NCT00141778|O1|Outcome|Placebo|Placebo Group
549304|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549305|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549306|NCT00141778|O1|Outcome|Placebo|Placebo Group
549307|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549308|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549309|NCT00141778|O1|Outcome|Placebo|Placebo Group
549310|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549311|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549312|NCT00141778|O1|Outcome|Placebo|Placebo Group
549313|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549314|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549315|NCT00141778|O1|Outcome|Placebo|Placebo Group
549316|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549317|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549318|NCT00141778|O1|Outcome|Placebo|Placebo Group
549319|NCT00141778|O3|Outcome|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549320|NCT00141778|O2|Outcome|Ramipril|Angiotensin-converting enzyme inhibitor group
549321|NCT00141778|O1|Outcome|Placebo|Placebo Group
549322|NCT00141778|E3|Reported Event|Spironolactone|Mineralocorticoid Receptor (MR) Antagonist group
549323|NCT00141778|E2|Reported Event|Ramipril|Angiotensin-converting enzyme inhibitor group
549324|NCT00141778|E1|Reported Event|Placebo|Placebo Group
549325|NCT00141765|B1|Baseline|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
549326|NCT00141765|P1|Participant Flow|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
549327|NCT00141765|O1|Outcome|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
549328|NCT00141765|E1|Reported Event|Myeloablative Chemotherapy With Stem Cell Rescue|"Myeloablative Chemotherapy: High dose chemotherapy (carboplatin and thiotepa) transplant rescue~Stem Cell Rescue: autologous stem cell transplantation"
549329|NCT00141739|B1|Baseline|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549330|NCT00141739|P1|Participant Flow|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549331|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549332|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549333|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549334|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549335|NCT00141739|O2|Outcome|Non-TBI|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549336|NCT00141739|O1|Outcome|Total Body Irradiation (TBI)|"GVHD prophylaxis with etanercept in patients receiving Total Body Irradiation (TBI) transplant conditioning.~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549337|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549338|NCT00141739|O1|Outcome|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549339|NCT00141739|E1|Reported Event|GVHD Prophylaxis|"GVHD prophylaxis with etanercept~Etanercept : Etanercept 0.4 mg/kg per dose [maximum dose 25 mg] SC for prophylaxis. To start in the 24 hour time period along with the initiation of the preparative regimen for the stem cell transplant.~Etanercept will be administered twice weekly until day +56 (8 weeks) post transplant."
549340|NCT00141726|B1|Baseline|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
549341|NCT00141726|P1|Participant Flow|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
549342|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
549343|NCT00141726|O1|Outcome|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
549344|NCT00141726|E1|Reported Event|Etanercept Treatment|"Etanercept for lung injury~Etanercept: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages."
549345|NCT00141518|B4|Baseline|Total|Total of all reporting groups
549346|NCT00141518|B3|Baseline|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549347|NCT00141518|B2|Baseline|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549348|NCT00141518|B1|Baseline|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549349|NCT00141518|P3|Participant Flow|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549350|NCT00141518|P2|Participant Flow|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549351|NCT00141518|P1|Participant Flow|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549352|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549546|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
549547|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549353|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549354|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549355|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549356|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549357|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549358|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549359|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549360|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549361|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549362|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549363|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549364|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549365|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549366|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549548|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
549549|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549367|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549368|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549369|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549370|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549371|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549372|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549373|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549374|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549375|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549376|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549377|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549378|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549379|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549380|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549550|NCT00141453|E2|Reported Event|Placebo Comparator|Matching placebo tablets
549551|NCT00141453|E1|Reported Event|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549381|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549382|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549383|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549384|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549385|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549386|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549387|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549388|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549389|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549390|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549391|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549392|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549393|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549394|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549552|NCT00141297|B3|Baseline|Total|Total of all reporting groups
550049|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
549395|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549396|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549397|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549398|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549399|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549400|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549401|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549402|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549403|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549404|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549405|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549406|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549407|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549408|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549870|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
557414|NCT00114634|O1|Outcome|Placebo|egg substitute
549409|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549410|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549411|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549412|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549413|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549414|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549415|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549416|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549417|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549418|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549419|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549420|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549421|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549422|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549871|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549423|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549424|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549425|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549426|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549427|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549428|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549429|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549430|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549431|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549432|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549433|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549434|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549435|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549436|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549872|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
550438|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
549437|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549438|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549439|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549440|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549441|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549442|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549443|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549444|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549445|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549446|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549447|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549448|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549449|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549450|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549873|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
557415|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
549451|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549452|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549453|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549454|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549455|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549456|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549457|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549458|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549459|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549460|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549461|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549462|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549463|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549464|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549874|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549465|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549466|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549467|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549468|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549469|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549470|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549471|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549472|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549473|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549474|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549475|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549476|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549477|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549478|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549875|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
550439|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
549479|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549480|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549481|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549482|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549483|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549484|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549485|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549486|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549487|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549488|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549489|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549490|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549491|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549492|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549876|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
557416|NCT00114634|O1|Outcome|Placebo|egg substitute
549493|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549494|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549495|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549496|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549497|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549498|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549499|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549500|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549501|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549502|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549503|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549504|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549505|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549506|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549877|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549507|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549508|NCT00141518|O1|Outcome|Total|Duodopa-naïve participants, Duodopa non-naïve participants treated with Duodopa for < 2 years, and Duodopa non-naïve participants treated with Duodopa for ≥ 2 years received Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549509|NCT00141518|O4|Outcome|Total|All participants
549510|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549511|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549512|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549513|NCT00141518|O4|Outcome|Total|All participants
549514|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549515|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549516|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549517|NCT00141518|O4|Outcome|Total|All participants
549518|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549519|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549520|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549521|NCT00141518|O4|Outcome|Total|All participants
549522|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549523|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549576|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549524|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549525|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549526|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549527|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549528|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549529|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549530|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549531|NCT00141518|O3|Outcome|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549532|NCT00141518|O2|Outcome|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549533|NCT00141518|O1|Outcome|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549534|NCT00141518|E3|Reported Event|Duodopa Non-naïve ≥ 2 Years|Duodopa non-naïve participants treated with Duodopa for ≥ 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549535|NCT00141518|E2|Reported Event|Duodopa Non-naïve < 2 Years|Duodopa non-naïve participants treated with Duodopa for < 2 years receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549536|NCT00141518|E1|Reported Event|Duodopa Naïve|Duodopa-naïve participants were titrated to receive Duodopa (levodopa/carbidopa intestinal gel) adjusted to an optimal clinical response for each participant, using the portable CADD Legacy Duodopa pump (CE 0473). Treatment is composed of 3 individually adjusted doses: the morning bolus dose (usually 5-10 mL [100-200 mg levodopa]); the continuous maintenance dose (usually 2-6 mL/hour [40-120 mg levodopa/hour]); and extra bolus doses, adjusted individually.
549537|NCT00141453|B3|Baseline|Total|Total of all reporting groups
549538|NCT00141453|B2|Baseline|Placebo Comparator|Matching placebo tablets
549539|NCT00141453|B1|Baseline|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549540|NCT00141453|P2|Participant Flow|Placebo Comparator|Matching placebo tablets
549541|NCT00141453|P1|Participant Flow|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549542|NCT00141453|O2|Outcome|Placebo Comparator|Matching placebo tablets
549543|NCT00141453|O1|Outcome|Olmesartan Medoxomil|Experimental: Olmesartan medoxomil tablets 10mg to 40 mg
549553|NCT00141297|B2|Baseline|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549554|NCT00141297|B1|Baseline|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549555|NCT00141297|P10|Participant Flow|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549556|NCT00141297|P9|Participant Flow|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549557|NCT00141297|P8|Participant Flow|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549558|NCT00141297|P7|Participant Flow|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549559|NCT00141297|P6|Participant Flow|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549560|NCT00141297|P5|Participant Flow|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549561|NCT00141297|P4|Participant Flow|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549562|NCT00141297|P3|Participant Flow|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549563|NCT00141297|P2|Participant Flow|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549564|NCT00141297|P1|Participant Flow|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549565|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549566|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549567|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549568|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549569|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549570|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549571|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549572|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549573|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549574|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549575|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549865|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549577|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549578|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549579|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549580|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549581|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549582|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549583|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549584|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549585|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549586|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549587|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549588|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549589|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549590|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549591|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549592|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549593|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549594|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549595|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549596|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549597|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549598|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549599|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549600|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549866|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549601|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549602|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549603|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549604|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549605|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549606|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549607|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549608|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549609|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549610|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549611|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549612|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549613|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549614|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549615|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549616|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549617|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549618|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549619|NCT00141297|O2|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549620|NCT00141297|O1|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549621|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549622|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549867|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549878|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549623|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549624|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549625|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549626|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549627|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549628|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549629|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549630|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549631|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549632|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549633|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549634|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549635|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549636|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549637|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549638|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549639|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549640|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549641|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549642|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549643|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549644|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549645|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549646|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549647|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549648|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549649|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549650|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549651|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549652|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549653|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549654|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549655|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549656|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549657|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549658|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549659|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549660|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549661|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549662|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549663|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549664|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549665|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549666|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549667|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549668|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549669|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549670|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549671|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549672|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549673|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549674|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549675|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549676|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549677|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549678|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549679|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549680|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549681|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549682|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549683|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549684|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549685|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549686|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549687|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549688|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549689|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549690|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549691|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549692|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549693|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549694|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549695|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549696|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549697|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549698|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549699|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549700|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549701|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549702|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549703|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549704|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549705|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549706|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549707|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549708|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549709|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549710|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549711|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549712|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
550047|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
549713|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549714|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549715|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549716|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549717|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549718|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549719|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549720|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549721|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549722|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549723|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549724|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549725|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549726|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549727|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549728|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549729|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549730|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549731|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549732|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549733|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549734|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549868|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549735|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549736|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549737|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549738|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549739|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549740|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549741|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549742|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549743|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549744|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549745|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549746|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549747|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549748|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549749|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549750|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549751|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549752|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549753|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549754|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549755|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549756|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549869|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549757|NCT00141297|O1|Outcome|PD 0332991 200 mg (14/21 Days) and 125 mg (21/28 Days)|Participants received PD 0332991 200 mg and 125 mg capsule orally once daily (QD), continuously for 14 days in 21-day cycles and continuously for 21 days in 28-day cycles, respectively. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549758|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549759|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549760|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549761|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549762|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles . Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549763|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549764|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549765|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549766|NCT00141297|O8|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549767|NCT00141297|O7|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549768|NCT00141297|O6|Outcome|PD 0332991 150 mg QD|Participants who received PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549769|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549770|NCT00141297|O4|Outcome|PD 0332991 100 mg QD|Participants who received PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles and continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549771|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549772|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549773|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549774|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549775|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549776|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549777|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549778|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549779|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
550440|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
549780|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549781|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549782|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549783|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549784|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549785|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549786|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549787|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549788|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549789|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549790|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549791|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549792|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549793|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549794|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549795|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549796|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549797|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549798|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549799|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549800|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549801|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549802|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549803|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
557675|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
549804|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549805|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549806|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549807|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549808|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549809|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549810|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549811|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549812|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549813|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549814|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549815|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549816|NCT00141297|O2|Outcome|PD 0332991 (14/21 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 14 days in 21-day cycles in dose escalation schemes of 100 mg, 150 mg and 200 mg, 225 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549817|NCT00141297|O1|Outcome|PD 0332991 (21/28 Days)|Participants received PD 0332991 capsule orally once daily (QD), continuously for 21 days in 28-day cycles in dose escalation schemes of 25 mg, 50 mg, 75 mg, 100 mg, 125 mg and 150 mg. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549818|NCT00141297|O10|Outcome|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549819|NCT00141297|O9|Outcome|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549820|NCT00141297|O8|Outcome|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549821|NCT00141297|O7|Outcome|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549822|NCT00141297|O6|Outcome|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549823|NCT00141297|O5|Outcome|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549824|NCT00141297|O4|Outcome|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549825|NCT00141297|O3|Outcome|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549826|NCT00141297|O2|Outcome|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
550441|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
549827|NCT00141297|O1|Outcome|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549828|NCT00141297|E10|Reported Event|PD 0332991 225 mg QD (14/21 Days)|PD 0332991 225 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549829|NCT00141297|E9|Reported Event|PD 0332991 200 mg QD (14/21 Days)|PD 0332991 200 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549830|NCT00141297|E8|Reported Event|PD 0332991 150 mg QD (14/21 Days)|PD 0332991 150 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549831|NCT00141297|E7|Reported Event|PD 0332991 100 mg QD (14/21 Days)|PD 0332991 100 mg capsule orally QD, continuously for 14 days in 21-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549832|NCT00141297|E6|Reported Event|PD 0332991 150 mg QD (21/28 Days)|PD 0332991 150 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549833|NCT00141297|E5|Reported Event|PD 0332991 125 mg QD (21/28 Days)|PD 0332991 125 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549834|NCT00141297|E4|Reported Event|PD 0332991 100 mg QD (21/28 Days)|PD 0332991 100 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549835|NCT00141297|E3|Reported Event|PD 0332991 75 mg QD (21/28 Days)|PD 0332991 75 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549836|NCT00141297|E2|Reported Event|PD 0332991 50 mg QD (21/28 Days)|PD 0332991 50 mg capsule orally QD, continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549837|NCT00141297|E1|Reported Event|PD 0332991 25 mg QD (21/28 Days)|PD 0332991 25 milligram (mg) capsule orally once daily (QD), continuously for 21 days in 28-day cycles. Treatment cycles were repeated until occurrence of disease progression, unacceptable toxicity, or investigator/participant decision to withdraw from study.
549838|NCT00141271|B4|Baseline|Total|Total of all reporting groups
549839|NCT00141271|B3|Baseline|Placebo|Subjects were assigned to placebo
549840|NCT00141271|B2|Baseline|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549841|NCT00141271|B1|Baseline|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549842|NCT00141271|P3|Participant Flow|Placebo|Subjects were assigned to placebo
549843|NCT00141271|P2|Participant Flow|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549844|NCT00141271|P1|Participant Flow|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549845|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549846|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549847|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549848|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549849|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549850|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549851|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549852|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549853|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549854|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549855|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549856|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549857|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549858|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549859|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549860|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549861|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549862|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549863|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549864|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
550442|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
549879|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549880|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549881|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549882|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549883|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549884|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549885|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549886|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549887|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549888|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549889|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549890|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549891|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549892|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549893|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549894|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549895|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549896|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549897|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549898|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549899|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549900|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549901|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549902|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549903|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549904|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549905|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549906|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549907|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549908|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549909|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549910|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549911|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549912|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549913|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549914|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549915|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549916|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549917|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549918|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549919|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549920|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549921|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549922|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549923|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549924|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549925|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549926|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549927|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549928|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549929|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549930|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549931|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549932|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549933|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549934|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549935|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549936|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549937|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549938|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549939|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549940|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549941|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549942|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549943|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549944|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549945|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549946|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549947|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549948|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549949|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549950|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549951|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549952|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549953|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549954|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549955|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549956|NCT00141271|O3|Outcome|Placebo|Subjects were assigned to placebo
549957|NCT00141271|O2|Outcome|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549958|NCT00141271|O1|Outcome|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549959|NCT00141271|E3|Reported Event|Placebo|Subjects were assigned to placebo
549960|NCT00141271|E2|Reported Event|40-80 mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 20-40 milligram (mg) twice a day (BID)
549961|NCT00141271|E1|Reported Event|120-160mg Ziprasidone|Subjects were assigned to a ziprasidone fixed-flexible dosing arm: 60-80 milligram (mg) BID (twice a day)
549962|NCT00141219|B3|Baseline|Total|Total of all reporting groups
549963|NCT00141219|B2|Baseline|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549964|NCT00141219|B1|Baseline|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549965|NCT00141219|P2|Participant Flow|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549966|NCT00141219|P1|Participant Flow|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549967|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549968|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549969|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549970|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549971|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549972|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549973|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549974|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549975|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549976|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549977|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549978|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549979|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549980|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549981|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549982|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549983|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549984|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549985|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549986|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549987|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549988|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549989|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549990|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549991|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549992|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549993|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549994|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549995|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549996|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549997|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
549998|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
549999|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550000|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550001|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550002|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550003|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550048|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550004|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550005|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550006|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550007|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550008|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550009|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550010|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550011|NCT00141219|O2|Outcome|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550012|NCT00141219|O1|Outcome|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550013|NCT00141219|E2|Reported Event|Placebo|Subjects who were randomized to placebo remained on placebo throughout the remainder of the study.
550014|NCT00141219|E1|Reported Event|Pregabalin|Dose levels of pregabalin were 150 mg/day, 300 mg/day, 450 mg/day, and 600 mg/day which were achieved by taking 75 mg, 150 mg, 225 mg (which was the combination of 75 mg + 150 mg) or 300 mg of pregabalin twice daily (BID), with or without food, once in the morning and once in the evening.
550015|NCT00141102|B3|Baseline|Total|Total of all reporting groups
550016|NCT00141102|B2|Baseline|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
550017|NCT00141102|B1|Baseline|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550018|NCT00141102|P2|Participant Flow|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550019|NCT00141102|P1|Participant Flow|Celecoxib|200 milligrams (mg) twice daily (BID) plus omeprazole placebo and diclofenac slow release (SR) placebo
550020|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550021|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550022|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550023|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550024|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550025|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550026|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550027|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550028|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
550029|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550030|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550031|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550032|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
550033|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550034|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550035|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550036|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550037|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550038|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550039|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550040|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg QD) and celecoxib placebo.
550041|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550042|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550043|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550044|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550045|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550046|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550050|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550051|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550052|NCT00141102|O2|Outcome|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550053|NCT00141102|O1|Outcome|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550054|NCT00141102|E2|Reported Event|Oral Diclofenac Plus Omeprazole|Oral diclofenac SR (75 mg BID) plus omeprazole (20 mg once daily [QD]) and celecoxib placebo.
550055|NCT00141102|E1|Reported Event|Celecoxib|200 mg BID plus omeprazole placebo and diclofenac SR placebo
550056|NCT00141037|B3|Baseline|Total|Total of all reporting groups
550057|NCT00141037|B2|Baseline|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550058|NCT00141037|B1|Baseline|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550059|NCT00141037|P2|Participant Flow|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550060|NCT00141037|P1|Participant Flow|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550061|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550062|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550063|NCT00141037|O2|Outcome|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550064|NCT00141037|O1|Outcome|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550065|NCT00141037|E2|Reported Event|Steroid-Free Immunosuppression|Subjects received extended daclizumab induction until the sixth month post-transplant (2 mg/kg pretransplant followed by 1 mg/kg at weeks 2, 4, 6, 8, 11 and months 4, 5, and 6), and maintenance combination tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post-transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550103|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550443|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550066|NCT00141037|E1|Reported Event|Steroid-Based Immunosuppression|Subjects received prednisone immunosuppression (10 mg/kg peri-operatively followed by 2 mg/kg/day in subjects weighing <40kg and 1.5 mg/kg/day in subjects weighing >40 kg, tapering according to the trial's protocol), standard daclizumab induction until the second month post transplant (1 mg/kg pre-transplant followed by 1 mg/kg at weeks 2, 4, 6, and 8), and maintenance tacrolimus and mycophenolate mofetil (MMF) immunosuppression. Anti-viral prophylactic treatment included: 1.) gancyclovir or oral valgancyclovir for at least the first 100 days post transplantation and 2.) trimethoprim/sulfamethoxazole for a minimum first 6 months post-transplantation. Refer to Registration Assigned Interventions for more details.
550067|NCT00140842|B3|Baseline|Total|Total of all reporting groups
550068|NCT00140842|B2|Baseline|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
550069|NCT00140842|B1|Baseline|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
550070|NCT00140842|P2|Participant Flow|Obese Girls|Obese adolescents between 12–18 years old.
550071|NCT00140842|P1|Participant Flow|Normal-weight Girls|Normal weight girls 12-18 years old
550072|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
550073|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
550074|NCT00140842|O2|Outcome|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
550075|NCT00140842|O1|Outcome|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
550076|NCT00140842|E2|Reported Event|Obese Girls|Obese girls were required to have a BMI above the 95th percentile
550077|NCT00140842|E1|Reported Event|Normal-weight Girls|Normal-weight girls were required to have a BMI between the 15th-85th percentiles
550078|NCT00140621|B1|Baseline|Agalsidase Beta|Agalsidase beta 1 mg/kg intravenously once every 2 weeks up to 156 weeks.
550079|NCT00140621|P1|Participant Flow|Agalsidase Beta (Fabrazyme [Recombinant Form])|Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
550080|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550081|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550082|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550083|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550084|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550085|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550086|NCT00140621|O1|Outcome|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550087|NCT00140621|E1|Reported Event|Agalsidase Beta|Agalsidase beta 1 mg/kg once every 2 weeks as an intravenous infusion up to 156 weeks.
550088|NCT00140556|B1|Baseline|Entire Study Population|
550089|NCT00140556|P1|Participant Flow|Entire Study Population|
550090|NCT00140556|O1|Outcome|Entire Study Population|
550091|NCT00140556|E1|Reported Event|Entire Study Population|
550092|NCT00140426|B3|Baseline|Total|Total of all reporting groups
550093|NCT00140426|B2|Baseline|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550094|NCT00140426|B1|Baseline|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550095|NCT00140426|P2|Participant Flow|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550096|NCT00140426|P1|Participant Flow|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550097|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550098|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550099|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550100|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550101|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550102|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550192|NCT00139776|P4|Participant Flow|Celecoxib 200mg Intermittent Use|Period III Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550104|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550105|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550106|NCT00140426|O1|Outcome|Risperidone or Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550107|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: this group of patients received the active study medication. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550108|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~This subject group received placebo tablets which appeared identical to risperidone"
550109|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550110|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550111|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550112|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550113|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550114|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550115|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550116|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550117|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication.~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550118|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. This is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550119|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550120|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550121|NCT00140426|O2|Outcome|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550122|NCT00140426|O1|Outcome|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550123|NCT00140426|E2|Reported Event|Risperidone|"Study is double blind, placebo controlled. This is the subject group on active medication~Risperidone: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa. Titration of study medication from 0.5 to 4 mg based on weight gain to target IBW."
550124|NCT00140426|E1|Reported Event|Placebo|"double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo.~Risperidone or placebo: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks."
550125|NCT00140413|B4|Baseline|Total|Total of all reporting groups
550126|NCT00140413|B3|Baseline|Treatment Group 2: Control|Subjects with normal growth were randomized to treatment or to control (no intervention).
550127|NCT00140413|B2|Baseline|Treatment Group 1B: Randomized to GH|Subjects with normal growth were randomized to GH treatment or to control (no intervention).
550128|NCT00140413|B1|Baseline|Treatment Group 1A: Assigned to GH|Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care.
550129|NCT00140413|P2|Participant Flow|Treatment Group 2: Control|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however, control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.
550130|NCT00140413|P1|Participant Flow|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
550131|NCT00140413|O3|Outcome|Treatment Group 3: Control Crossed Over to Treatment|3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
550132|NCT00140413|O2|Outcome|Treatment Group 2: Control|"Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with normal growth were randomized to treatment or to control. The control group received no intervention; however control subjects were switched (crossed over) to the GH replacement group if, during the course of the study, they met criteria for growth deceleration.~A total of 7 subjects were randomized to the control group, 3 of whom were crossed over to treatment due to growth deceleration. Outcome measures for these 3 who crossed over were analyzed separately, under Treatment Group 3."
550133|NCT00140413|O1|Outcome|Treatment Group 1: Receiving Growth Hormone Treatment|Treatment group assignment was based on subject’s stature SDS relative to the mid-parental target height (MPTH) at baseline and subsequent classification as growth deceleration or normal growth. Subjects with growth deceleration were assigned to the GH replacement treatment group in accordance with standard of care. Subjects with normal growth were randomized to treatment or to control (no intervention). The starting daily dose for GH replacement was calculated as 0.3 mg/kg/wk and subsequently modified based on observed length/height velocity and serum IGF-I levels.
550134|NCT00140413|E2|Reported Event|Treatment Group 2: Control|The denominator below (# at risk) is based on the number of subjects in Group 2 who received at least one dose of growth hormone. Per protocol, control subjects received no intervention; however, 3 control subjects were switched (crossed over) to the GH replacement group during the course of the study due to growth deceleration.
550135|NCT00140413|E1|Reported Event|Treatment Group 1: Receiving Growth Hormone Treatment|The denominator below (# at risk) is based on the number of subjects in Group 1 who received at least one dose of growth hormone.
550136|NCT00140140|B4|Baseline|Total|Total of all reporting groups
550137|NCT00140140|B3|Baseline|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550138|NCT00140140|B2|Baseline|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550139|NCT00140140|B1|Baseline|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550140|NCT00140140|P3|Participant Flow|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550141|NCT00140140|P2|Participant Flow|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550142|NCT00140140|P1|Participant Flow|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550143|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550144|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550145|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550146|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550193|NCT00139776|P3|Participant Flow|Celecoxib 200mg Continuous Use|Period III Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
557676|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
550147|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550148|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550149|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550150|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550151|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550152|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550153|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550154|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550155|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550156|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550157|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550158|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550159|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550160|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550161|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550162|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550163|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550275|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
557677|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
550164|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550165|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550166|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550167|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550168|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550169|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550170|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550171|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550172|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550173|NCT00140140|O3|Outcome|Part 2: 90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550174|NCT00140140|O2|Outcome|Part 2: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. G-CSF support was given.
550175|NCT00140140|O1|Outcome|Part 1: 80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants with human epidermal growth factor receptor 2-positive (HER2+) and who met cardiac safety requirements were also administered weekly Herceptin® (trastuzumab) following completion of ABI-007 and vinorelbine infusions. No G-CSF support was planned.
550176|NCT00140140|E2|Reported Event|90 mg ABI-007 + 20 mg Vinorelbine|Weekly intravenous infusion of 90 mg/m^2 ABI-007, followed by an infusion of 20 mg/m^2 vinorelbine. Participants are from study Part 2.
550177|NCT00140140|E1|Reported Event|80 mg ABI-007 + 15 mg Vinorelbine|Weekly intravenous infusion of 80 mg/m^2 ABI-007, followed by an infusion of 15 mg/m^2 vinorelbine. Participants from study Parts 1 and 2 are combined.
550178|NCT00139997|B3|Baseline|Total|Total of all reporting groups
550179|NCT00139997|B2|Baseline|Inactive Intervention|Equivalent exposure to inactive negative ion generator
550180|NCT00139997|B1|Baseline|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
550181|NCT00139997|P2|Participant Flow|Inactive Intervention|Equivalent exposure to inactive negative ion generator
550182|NCT00139997|P1|Participant Flow|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
550183|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
550184|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
550185|NCT00139997|O2|Outcome|Inactive Intervention|Equivalent exposure to inactive negative ion generator
550186|NCT00139997|O1|Outcome|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
550187|NCT00139997|E2|Reported Event|Inactive Intervention|Equivalent exposure to inactive negative ion generator
550188|NCT00139997|E1|Reported Event|LED Phototherapy|Phototherapy with light-emitting diode phototherapy device
550189|NCT00139776|B3|Baseline|Total|Total of all reporting groups
550190|NCT00139776|B2|Baseline|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550191|NCT00139776|B1|Baseline|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550432|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550194|NCT00139776|P2|Participant Flow|Open-Label Celecoxib Run-in Period|Period II (14+/-2 days) run-in treatment with open label celecoxib to observe successful treatment of flare. Participants successfully treated randomized to 2 treatment groups in Period III (overall study).
550195|NCT00139776|P1|Participant Flow|Wash-Out: Discontinue Non-Steroidal Anti-Inflammatories|Period I (14+/-2 days) wash out and discontinuation of non-steroidal anti-inflammatories (NSAIDs) leading to osteoarthritis (OA) flare.
550196|NCT00139776|O1|Outcome|Celecoxib 200mg Open Label|Period II run-in (2 weeks). Celecoxib 200 mg daily until resolution of screening osteoarthritis flare as defined by IVRS
550197|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550198|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550199|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550200|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550201|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550202|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550203|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550204|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550205|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550206|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550207|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550208|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550209|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550210|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550211|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550212|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550213|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550214|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550215|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550216|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550217|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550218|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550219|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550220|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550221|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550222|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550223|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550224|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550225|NCT00139776|O2|Outcome|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550226|NCT00139776|O1|Outcome|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550227|NCT00139776|E2|Reported Event|Celecoxib 200mg Intermittent Use|Double blind placebo was taken once daily. Usual or intermittent use of celecoxib 200 mg daily as flare medication when directed.
550228|NCT00139776|E1|Reported Event|Celecoxib 200mg Continuous Use|Double blind single dose of celecoxib 200 mg daily. Placebo used as flare medication when directed.
550229|NCT00139737|B1|Baseline|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
550230|NCT00139737|P1|Participant Flow|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
550231|NCT00139737|O1|Outcome|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
550232|NCT00139737|E1|Reported Event|Ziprasidone|Ziprasidone treatment was continued at the same dose used in the previous protocol with subsequent dose adjustments within 20-40-60-80 mg twice daily according to investigator’s opinion on clinical status of subject. The maximum total daily oral dose allowed was 160 mg.
550233|NCT00139659|B3|Baseline|Total|Total of all reporting groups
550234|NCT00139659|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550235|NCT00139659|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550236|NCT00139659|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550237|NCT00139659|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550238|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550239|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550240|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550241|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550242|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550243|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550244|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550245|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550246|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550247|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550248|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550249|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550250|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550251|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550252|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550253|NCT00139659|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550254|NCT00139659|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550255|NCT00139659|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550256|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550257|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550258|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550259|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550260|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550261|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550262|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550263|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550264|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550265|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550266|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550267|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550268|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550269|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550270|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550271|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550272|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550273|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550274|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550276|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550277|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550278|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550279|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550280|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550281|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550282|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550283|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550284|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550285|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550286|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550287|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550288|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550289|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550290|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550291|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550292|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550293|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550294|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550295|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550296|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550297|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550298|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550299|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550300|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550301|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550302|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550303|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550304|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550305|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550306|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550307|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550308|NCT00139659|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550309|NCT00139659|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550310|NCT00139659|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550311|NCT00139659|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550312|NCT00139477|B3|Baseline|Total|Total of all reporting groups
550313|NCT00139477|B2|Baseline|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
550314|NCT00139477|B1|Baseline|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
550315|NCT00139477|P2|Participant Flow|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
550316|NCT00139477|P1|Participant Flow|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
550317|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550318|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550319|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550320|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550321|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550322|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550323|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550324|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550325|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550326|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550327|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550328|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550329|NCT00139477|O4|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Pubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550330|NCT00139477|O3|Outcome|Diet/Exercise Plus Metformin, Then Diet/Exercise (Prepubertal)|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550331|NCT00139477|O2|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Pubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550332|NCT00139477|O1|Outcome|Diet/Exercise, Then Diet/Exercise Plus Metformin (Prepubertal)|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period). Results displayed for prepubertal versus pubertal participants.
550333|NCT00139477|E2|Reported Event|Diet/Exercise Plus Metformin, Then Diet/Exercise Only|Diet/Exercise plus Metformin in first intervention period and Diet/Exercise only in second intervention period (no washout period).
550334|NCT00139477|E1|Reported Event|Diet/Exercise Only, Then Diet/Exercise Plus Metformin|Diet/Exercise only in first intervention period and Diet/Exercise plus Metformin in second intervention period (no washout period).
550335|NCT00138671|B3|Baseline|Total|Total of all reporting groups
550336|NCT00138671|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550337|NCT00138671|B1|Baseline|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550338|NCT00138671|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550339|NCT00138671|P1|Participant Flow|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550340|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550341|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550342|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550343|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550344|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550345|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550346|NCT00138671|O2|Outcome|Subcutaneous Insulin|
550347|NCT00138671|O1|Outcome|Inhaled Insulin|
550348|NCT00138671|O2|Outcome|Subcutaneous Insulin|
550349|NCT00138671|O1|Outcome|Inhaled Insulin|
550350|NCT00138671|O2|Outcome|Subcutaneous Insulin|
550351|NCT00138671|O1|Outcome|Inhaled Insulin|
550352|NCT00138671|O2|Outcome|Subcutaneous Insulin|
550353|NCT00138671|O1|Outcome|Inhaled Insulin|
550354|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550355|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550356|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550357|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550358|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550359|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550360|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550361|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550362|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550363|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550364|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550365|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550366|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550367|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550368|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550369|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550370|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550371|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550372|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550373|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550374|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550375|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550376|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550377|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550378|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550379|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550380|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550381|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550382|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550383|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550384|NCT00138671|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550385|NCT00138671|O1|Outcome|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550386|NCT00138671|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550387|NCT00138671|E1|Reported Event|Inhaled Insulin|Inhaled insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550388|NCT00138658|B1|Baseline|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550389|NCT00138658|P1|Participant Flow|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550390|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
550391|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
550433|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550434|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550435|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550436|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550437|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550392|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550393|NCT00138658|O1|Outcome|Patients in Phase I Receiving 640 mg of OGX-011|Per protocol, ten subjects enrolled in the Phase I portion of the study. Three subjects received 480 mg; 6 subjects received 640 mg doses of OGX-011; and 1 patient discontinued prior to Cycle 1 Day 1 due to disease progression.
550394|NCT00138658|O1|Outcome|Mean Reduction in Serum Clusterin From Baseline|The mean reduction in serum clusterin was calculated by determining the difference from baseline to the minimum post baseline level. The reduction in serum clusterin was determined for all subjects who had baseline and at least one post-baseline serum clusterin assessment (n=55).
550395|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550396|NCT00138658|O1|Outcome|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550397|NCT00138658|E1|Reported Event|OGX-011 - Intent to Treat Analysis Set|Custirsen sodium (OGX-011) was to be infused intravenously over 2 hours on Days -7, -5, and -3 of Cycle 1 (Pretreatment loading doses). OGX-011 was then to be infused for 2 hours weekly on Days 1, 8, and 15 of a 21-day cycle. Gemcitabine (GEM) was to be infused IV for 30 minutes on Days 1 and 8 and either cisplatin (CIS) or carboplatin (CARBO) were to be infused IV on Day of the 21-day cycle. Patients were to receive a maximum of 6 cycles (1 cycle =21 days). Most patients received OGX-011 at 640 mg; but 3 patients received a 480 mg dose. The 2 dose groups were combined due to the small number of patients who received 480 mg. All patients who received at least one dose of OGX-011 were included in the Intent to Treat Analysis Set.
550398|NCT00138645|B3|Baseline|Total|Total of all reporting groups
550399|NCT00138645|B2|Baseline|Healthy Diet|Healthy Diet
550400|NCT00138645|B1|Baseline|MicroDiet|MicroDiet
550401|NCT00138645|P2|Participant Flow|Healthy Diet|Healthy Diet
550402|NCT00138645|P1|Participant Flow|MicroDiet|MicroDiet
550403|NCT00138645|O2|Outcome|Healthy Diet|Healthy Diet
550404|NCT00138645|O1|Outcome|MicroDiet|MicroDiet
550405|NCT00138645|E2|Reported Event|Healthy Diet|participants randomized to the low-calorie diet.
550406|NCT00138645|E1|Reported Event|MicroDiet|Participants randomized to the MicroDiet
550407|NCT00138424|B5|Baseline|Total|Total of all reporting groups
550408|NCT00138424|B4|Baseline|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550409|NCT00138424|B3|Baseline|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550410|NCT00138424|B2|Baseline|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550411|NCT00138424|B1|Baseline|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550412|NCT00138424|P4|Participant Flow|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550413|NCT00138424|P3|Participant Flow|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550414|NCT00138424|P2|Participant Flow|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550415|NCT00138424|P1|Participant Flow|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550416|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
550417|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
550418|NCT00138424|O2|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week - days 0, 7, 21, 35, 49)
550419|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week - days 0, 7, 21, 35, 49)
550420|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550421|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550422|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550423|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550424|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550425|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550426|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550427|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550428|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550429|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550430|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550431|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550444|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550445|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550446|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550447|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550448|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550449|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550450|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550451|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550452|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550453|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550454|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550455|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550456|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550457|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550458|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550459|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550460|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550461|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550462|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550463|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550464|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550465|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550466|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550467|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550468|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550469|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550470|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550471|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550472|NCT00138424|O4|Outcome|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550473|NCT00138424|O3|Outcome|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550474|NCT00138424|O2|Outcome|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550475|NCT00138424|O1|Outcome|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550476|NCT00138424|E4|Reported Event|Cohort II - Placebo|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550477|NCT00138424|E3|Reported Event|Cohort II - Cidofovir|One dose (0.5 mg/kg/week-days 0, 7, 21, 35, 49)
550478|NCT00138424|E2|Reported Event|Cohort I - Placebo|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550479|NCT00138424|E1|Reported Event|Cohort I - Cidofovir|One dose (0.25 mg/kg/week-days 0, 7, 21, 35, 49)
550480|NCT00138203|B1|Baseline|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
550481|NCT00138203|P1|Participant Flow|SAHA|Suberoylanilide Hydroxamic Acid (SAHA), 400mg orally, once daily, in a 21 day cycle.
550482|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
550483|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
550484|NCT00138203|O1|Outcome|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
550485|NCT00138203|E1|Reported Event|SAHA|Suberoylanilide Hydroxamic Acid (SAHA)
550486|NCT00138151|B1|Baseline|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550487|NCT00138151|P1|Participant Flow|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550488|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550489|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550490|NCT00138151|O1|Outcome|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550491|NCT00138151|E1|Reported Event|Paclitaxel, 13-cis Retinoic Acid, and Interferon Alpha-2b|"Cis-retinoic acid at a dose of 1 mg/kg/day PO qd days 1-4 of each cycle~Interferon alpha-2b at a dose of 6 mU/m2 SQ qd days 1-4 of each cycle~Paclitaxel 175 mg/m2 will be given on day 4. Cycles will be repeated every 21 days"
550492|NCT00138125|B1|Baseline|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
550493|NCT00138125|P1|Participant Flow|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
550834|NCT00136695|P2|Participant Flow|Placebo|"placebo~anastrozole: 1 mg QD"
550494|NCT00138125|O1|Outcome|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
550495|NCT00138125|E1|Reported Event|Faslodex + Herceptin|"Faslodex : Administered IM at 500 mg on day 1 of cycle 1, followed by 500 mg on day 15 of cycle 1, then 500 mg on day 1 of each cycle thereafter.~Herceptin : Given at 4 mg/kg IV on day 1 (cycle 1) then 2mg/kg IV weekly"
550496|NCT00138073|B1|Baseline|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
550497|NCT00138073|P1|Participant Flow|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
550498|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
550499|NCT00138073|O1|Outcome|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
550500|NCT00138073|E1|Reported Event|Web-based Waveform Interpretation Guide|"The arm has access to the Web-based waveform interpretation guide.~Web-based waveform interpretation guide: Use of an educational website."
550501|NCT00138034|B3|Baseline|Total|Total of all reporting groups
550502|NCT00138034|B2|Baseline|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
550503|NCT00138034|B1|Baseline|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
550504|NCT00138034|P2|Participant Flow|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
550505|NCT00138034|P1|Participant Flow|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
550506|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
550507|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
550508|NCT00138034|O2|Outcome|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
550509|NCT00138034|O1|Outcome|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
550510|NCT00138034|E2|Reported Event|Conservative Treatment|Conservative treatment of culprit lesion with dual antiplatelet therapy
550511|NCT00138034|E1|Reported Event|Percutaeous Coronary Intervention (PCI)|Stenting of culprit lesion followed by dual antiplatelet therapy
550512|NCT00137969|B3|Baseline|Total|Total of all reporting groups
550513|NCT00137969|B2|Baseline|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550514|NCT00137969|B1|Baseline|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550515|NCT00137969|P2|Participant Flow|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550516|NCT00137969|P1|Participant Flow|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550517|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550518|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550519|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550520|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550521|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550547|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550835|NCT00136695|P1|Participant Flow|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
550522|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550523|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550524|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550525|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550526|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550527|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550528|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550529|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550530|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550531|NCT00137969|O2|Outcome|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550532|NCT00137969|O1|Outcome|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550533|NCT00137969|E2|Reported Event|Placebo + Prednisone|Participants received placebo intravenously on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550534|NCT00137969|E1|Reported Event|Rituximab 1000 mg + Prednisone|Participants received rituximab 1000 mg intravenously (IV) on Days 1, 15, 168, and 182. Participants also received an initial dose of prednisone (0.5, 0.75, or 1.0 mg/kg orally once a day) with tapering beginning at Day 16 for 10 weeks to a dose of ≤ 10 mg/day. Participants also received acetaminophen 1000 mg orally and diphenhydramine 50 mg orally prior to study drug infusion.
550535|NCT00137631|B3|Baseline|Total|Total of all reporting groups
550536|NCT00137631|B2|Baseline|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550537|NCT00137631|B1|Baseline|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550538|NCT00137631|P2|Participant Flow|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550539|NCT00137631|P1|Participant Flow|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550540|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550541|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550542|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550543|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550544|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550545|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550546|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550548|NCT00137631|O2|Outcome|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550549|NCT00137631|O1|Outcome|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550550|NCT00137631|E2|Reported Event|Wait List Comparison|Receive intervention after 6-month delay (wait list control group)
550551|NCT00137631|E1|Reported Event|Many Men, Many Voices (3MV) Intervention|Receive 6-session intervention immediately after baseline assessment and randomization
550552|NCT00137449|B3|Baseline|Total|Total of all reporting groups
550553|NCT00137449|B2|Baseline|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550554|NCT00137449|B1|Baseline|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550555|NCT00137449|P2|Participant Flow|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550556|NCT00137449|P1|Participant Flow|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550557|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550558|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550559|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550560|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550561|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550562|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550563|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550564|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550565|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550566|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550567|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550568|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550569|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550570|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550693|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550694|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550571|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550572|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550573|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550574|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550575|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550576|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550577|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550578|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550579|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550580|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550581|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550582|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550583|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550584|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550585|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550586|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550587|NCT00137449|O3|Outcome|Total (Equals AM Plus PM Dose) Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550588|NCT00137449|O2|Outcome|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550589|NCT00137449|O1|Outcome|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550590|NCT00137449|E2|Reported Event|PM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550695|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550591|NCT00137449|E1|Reported Event|AM Dose Sunitinib Malate|Subjects received sunitinib malate at a starting dose of 37.5 mg/day in repeated 4-week cycles and cycles could be repeated for up to 1 year in the absence of any withdrawal criteria. Subjects were randomized to receive either morning (AM) or afternoon (PM) dose. Doses could be increased to 50 mg daily.
550592|NCT00137436|B1|Baseline|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550593|NCT00137436|P1|Participant Flow|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|Sunitinib 37.5 milligrams (mg) plus (+) Docetaxel 75 mg per meters squared (mg/m^2) + Prednisone 5 mg given twice daily
550594|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550595|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550596|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550597|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550598|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550599|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550600|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550601|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550602|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550603|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550604|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550605|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550606|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550607|NCT00137436|O1|Outcome|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550608|NCT00137436|E1|Reported Event|SU011248 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg|SU011248 (Sunitinib Malate) 37.5 mg + Docetaxel 75 mg/m^2 + Prednisone 5 mg given twice daily
550609|NCT00137423|B3|Baseline|Total|Total of all reporting groups
550610|NCT00137423|B2|Baseline|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550611|NCT00137423|B1|Baseline|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550612|NCT00137423|P2|Participant Flow|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550613|NCT00137423|P1|Participant Flow|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550614|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550615|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550696|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550616|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550617|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550618|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.Per the statistical analysis plan, the primary outcome of objective response was evaluated in patients who had measurable disease at baseline, the correct histological cancer type, & were refractory to prior cytokine-based therapy. Of 107 subjects enrolled, 2 patients did not have measurable disease at baseline, and therefore, were excluded from the analysis.
550619|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550620|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550621|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550622|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550623|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550624|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550625|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550626|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550627|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550628|NCT00137423|O2|Outcome|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550629|NCT00137423|O1|Outcome|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550630|NCT00137423|E2|Reported Event|PM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the evening repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550631|NCT00137423|E1|Reported Event|AM Dose Sunitinib Malate (SU011248)|Patients received a starting dose of 37.5 mg/day of sunitinib malate in the morning repeated 4-week cycles continuing for up to 1 year in absence of any withdrawal criteria.
550632|NCT00137280|B3|Baseline|Total|Total of all reporting groups
550633|NCT00137280|B2|Baseline|Usual Care|Continue with usual care
550634|NCT00137280|B1|Baseline|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550635|NCT00137280|P2|Participant Flow|Usual Care|Continue with usual care
550636|NCT00137280|P1|Participant Flow|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550637|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
550638|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550639|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
550640|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550641|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
550642|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550643|NCT00137280|O2|Outcome|Usual Care|Continue with usual care
550644|NCT00137280|O1|Outcome|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550645|NCT00137280|E2|Reported Event|Usual Care|Continue with usual care
550646|NCT00137280|E1|Reported Event|Collaborative Chronic Illness Care Model|A care model that integrates greater availability of clinical information, reorganizes the practice system and provider roles, fosters care coordination, and focuses on evidence-based protocols--specifically supported employment and wellness services for individuals with schizophrenia.
550647|NCT00137267|B3|Baseline|Total|Total of all reporting groups
550648|NCT00137267|B2|Baseline|Arm 2 - Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
550649|NCT00137267|B1|Baseline|Arm 1 - Time Limited Case Management (TLC)|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
550650|NCT00137267|P2|Participant Flow|Health Education|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group."
550651|NCT00137267|P1|Participant Flow|Time Limited Case Management|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
550652|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
550653|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
550654|NCT00137267|O2|Outcome|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
550697|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550698|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550699|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550836|NCT00136695|O2|Outcome|Placebo|"placebo~anastrozole: 1 mg QD"
550655|NCT00137267|O1|Outcome|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
550656|NCT00137267|E2|Reported Event|Arm 2|"This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group.~Health Education: This group will receive treatment as usual in Acute Psychiatry and at the Day Treatment Center in addition to participating in four group and one individual health education sessions (i.e., the attention control group). The length of the health education sessions (four group sessions and one individual session) will match the amount of attention provided to the treatment group. The health education sessions will cover topics such as nutrition, disease prevention, injury prevention, and healthy aging."
550657|NCT00137267|E1|Reported Event|Arm 1|"This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition.~Time limited case management: This group will receive treatment as usual on Acute Psychiatry and at the Day Treatment Center along with an enhanced Time Limited Case Management community linkage intervention (TLC). Patients assigned to TLC will be offered enhanced services that begin on Acute Psychiatry and continue for a total of eight weeks through the community and Day Treatment Center transition."
550658|NCT00137111|B5|Baseline|Total|Total of all reporting groups
550659|NCT00137111|B4|Baseline|Non Randomized|Patients not randomized for window study
550660|NCT00137111|B3|Baseline|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
550661|NCT00137111|B2|Baseline|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
550662|NCT00137111|B1|Baseline|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
550663|NCT00137111|P4|Participant Flow|Non Randomized|Patients not randomized for window study
550664|NCT00137111|P3|Participant Flow|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
550665|NCT00137111|P2|Participant Flow|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
550666|NCT00137111|P1|Participant Flow|Total Therapy|Total therapy applies to all eligible patients and includes remission induction, consolidation, and continuation therapy.
550667|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
550668|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
550669|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
550670|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
550671|NCT00137111|O2|Outcome|24 hr|24 hour High-Dose Methotrexate Infusion in upfront window treatment
550672|NCT00137111|O1|Outcome|4 hr|4 hour High-Dose Methotrexate Infusion in upfront window treatment
550673|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
550674|NCT00137111|O1|Outcome|Patients With High Risk of CNS Relapse|This is a subset of all patients enrolled. It is not a specific treatment arm.
550675|NCT00137111|O1|Outcome|Total Therapy|Total therapy applies to all eligible patients.
550676|NCT00137111|E1|Reported Event|Total Therapy|Total therapy applies to all eligible patients.
550677|NCT00137046|B3|Baseline|Total|Total of all reporting groups
550678|NCT00137046|B2|Baseline|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550679|NCT00137046|B1|Baseline|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550680|NCT00137046|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550681|NCT00137046|P1|Participant Flow|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550682|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550683|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550684|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550685|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550686|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550687|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550688|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550689|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550690|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550691|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550692|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550831|NCT00136695|B3|Baseline|Total|Total of all reporting groups
550700|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550701|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550702|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550703|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550704|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units/kg)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550705|NCT00137046|O1|Outcome|Inhaled Insulin (mg/kg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550706|NCT00137046|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550707|NCT00137046|O1|Outcome|Inhaled Insulin (mg)|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550708|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550709|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550710|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550711|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550712|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550713|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550714|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550715|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550716|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550717|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550718|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550719|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550720|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550721|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550722|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550723|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550724|NCT00137046|O2|Outcome|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550725|NCT00137046|O1|Outcome|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550726|NCT00137046|E2|Reported Event|Subcutaneous Insulin|Subcutaneous insulin with dose adjusted according to premeal blood glucose plus basal insulin.
550727|NCT00137046|E1|Reported Event|Inhaled Insulin|Inhaled insulin (Exubera®) with dose adjusted according to premeal blood glucose plus basal insulin.
550728|NCT00136955|B1|Baseline|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550729|NCT00136955|P1|Participant Flow|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550730|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550731|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550732|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550733|NCT00136955|O1|Outcome|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550734|NCT00136955|E1|Reported Event|Irinotecan/Cisplatin|Intravenous irinotecan (60 milligrams [mg]/metered square [m2]) on days 1, 8, and 15 plus cisplatin (60mg/m2) on day 1. Treatment cycle was repeated every 4 weeks.
550735|NCT00136916|B3|Baseline|Total|Total of all reporting groups
550736|NCT00136916|B2|Baseline|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550737|NCT00136916|B1|Baseline|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550738|NCT00136916|P2|Participant Flow|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550739|NCT00136916|P1|Participant Flow|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550740|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550741|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550742|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550743|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550744|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550745|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550746|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550747|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550748|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550749|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550750|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550751|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550752|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550753|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550754|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550755|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550756|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550757|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550758|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550759|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550760|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550761|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550762|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550763|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550832|NCT00136695|B2|Baseline|Placebo|"placebo~anastrozole: 1 mg QD"
550764|NCT00136916|O2|Outcome|Subcutaneous Insulin (Units)|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550765|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®) (mg)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550766|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550767|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550768|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550769|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550770|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550771|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550772|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550773|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550774|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550775|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550776|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550777|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550778|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550779|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550780|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550781|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550782|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550783|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550784|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550785|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550786|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550787|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550833|NCT00136695|B1|Baseline|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
550788|NCT00136916|O2|Outcome|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550789|NCT00136916|O1|Outcome|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550790|NCT00136916|E2|Reported Event|Subcutaneous Insulin|Subcutaneous (SC) insulin: 2 to 3 daily doses of regular insulin or short-acting insulin analog (lispro or aspart) plus 1 or 2 daily doses of an intermediate to long-acting insulin (NPH insulin or Ultralene®), or insulin glargine QD at bedtime.
550791|NCT00136916|E1|Reported Event|Inhaled Insulin (Exubera®)|Pre-prandial inhalable short-acting insulin (INH) regime (packaged as 1 mg and 3 mg inhalation blister packs) plus a single bedtime dose or 2 daily doses of either Ultralene® or NPH insulin, or insulin glargine once daily (QD) at bedtime.
550792|NCT00136838|B1|Baseline|Study Participants|This is a within-group study design, all participant who completed the study completed 2 phases of treatment, done in random order, each lasting 5 days and separated by at least 2 weeks. During one of the phases participants were exposed to active cigarette cues (pack of cigarettes, smoke) and during the other phase they were exposed to sham control cues (water bottle and the glass)
550793|NCT00136838|P2|Participant Flow|Active Cue First, Then Neutral Cue|"Each participant receives two consecutive interventions in random order.~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue"
550794|NCT00136838|P1|Participant Flow|Neutral Cue First, Then Active Cue|"Participants receives two consecutive interventions in random order.~Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue~Cigarette cue: during this phase of treatment participants were presented with active cigarette cue"
550795|NCT00136838|O2|Outcome|Neutral Cue Craving|intensity of craving following cue exposure
550796|NCT00136838|O1|Outcome|Active Cue Craving|intensity of craving following cue exposure
550797|NCT00136838|O2|Outcome|Neutral Cue|During this phase of study participants were exposed to a neutral (sham) cue: a bottle of water and a glass
550798|NCT00136838|O1|Outcome|Active Cue|During this phase participants were exposed to active cigarette cues: pack of cigarettes and a cigarette smoke
550799|NCT00136838|E2|Reported Event|Active Cue|1.Cigarette cue: during this phase of treatment participants were presented with active cigarette cue.
550800|NCT00136838|E1|Reported Event|Neutral Cue|Neutral Cue: during this phase of treatment participants were presented with neutral (sham) cue
550801|NCT00136812|B3|Baseline|Total|Total of all reporting groups
550802|NCT00136812|B2|Baseline|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
550803|NCT00136812|B1|Baseline|Control|Usual care provided NRT during hospitalization with brief cessation advice.
550804|NCT00136812|P2|Participant Flow|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
550805|NCT00136812|P1|Participant Flow|Control|Usual care provided NRT during hospitalization with brief cessation advice.
550806|NCT00136812|O2|Outcome|Brief Treatment|The intervention included a Transtheoretical Model-tailored computerized program and print workbook; brief on-unit counseling session; and nicotine replacement therapy (NRT) during hospitalization with access to 10 weeks of NRT post-hospitalization.
550807|NCT00136812|O1|Outcome|Control|Usual care provided NRT during hospitalization with brief cessation advice.
550808|NCT00136812|E2|Reported Event|2: Intervention|"intervention~Tobacco Use Cessation: This intervention consists of nicotine patch therapy during hospitalization; a stage-based self-help manual; an individualized, expert-system, feedback report at intake, 3 months and 6 months post-hospitalization with carbon copies sent to participants' outpatient clinicians; and an individual 30-min smoking cessation counseling sessions during hospitalization. Additionally, up to 10 weeks of nicotine patch is provided to intervention participants intending to stay quit following hospital discharge."
550809|NCT00136812|E1|Reported Event|1: Enhanced Standard Care Control|enhanced standard care control
550810|NCT00136760|B5|Baseline|Total|Total of all reporting groups
550811|NCT00136760|B4|Baseline|NR + PLA|Non-contingent reinforcement plus placebo
550812|NCT00136760|B3|Baseline|NR + BUP|Non-contingent reinforcement plus bupropion
550813|NCT00136760|B2|Baseline|CM + PLA|Contingent reinforcement plus placebo
550814|NCT00136760|B1|Baseline|CM + BUP|Contingent reinforcement plus bupropion
550815|NCT00136760|P4|Participant Flow|NR + PLA|Non-contingent reinforcement plus placebo
550816|NCT00136760|P3|Participant Flow|NR + BUP|Non-contingent reinforcement plus bupropion
550817|NCT00136760|P2|Participant Flow|CM + PLA|Contingent reinforcement plus placebo
550818|NCT00136760|P1|Participant Flow|CM + BUP|Contingent reinforcement plus bupropion
550819|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
550820|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
550821|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
550822|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
550823|NCT00136760|O4|Outcome|NR + PLA|Non-contingent reinforcement plus placebo
550824|NCT00136760|O3|Outcome|NR + BUP|Non-contingent reinforcement plus bupropion
550825|NCT00136760|O2|Outcome|CM + PLA|Contingent reinforcement plus placebo
550826|NCT00136760|O1|Outcome|CM + BUP|Contingent reinforcement plus bupropion
550827|NCT00136760|E4|Reported Event|NR + PLA|Non-contingent reinforcement plus placebo
550828|NCT00136760|E3|Reported Event|NR + BUP|Non-contingent reinforcement plus bupropion
550829|NCT00136760|E2|Reported Event|CM + PLA|Contingent reinforcement plus placebo
550830|NCT00136760|E1|Reported Event|CM + BUP|Contingent reinforcement plus bupropion
550839|NCT00136695|E1|Reported Event|Anastrozole|"anastrozole~anastrozole: 1 mg QD"
550840|NCT00136357|B3|Baseline|Total|Total of all reporting groups
550841|NCT00136357|B2|Baseline|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
550842|NCT00136357|B1|Baseline|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
550843|NCT00136357|P2|Participant Flow|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
550844|NCT00136357|P1|Participant Flow|Mind-Body Skills Groups|12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
550845|NCT00136357|O2|Outcome|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
550846|NCT00136357|O1|Outcome|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
550847|NCT00136357|E2|Reported Event|Delayed Intervention|Comparison group not receiving intervention until after the initial intervention was completed.
550848|NCT00136357|E1|Reported Event|Mind-Body Skills Groups|"12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.~Mind-Body Skills Groups: 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques."
550849|NCT00136318|B3|Baseline|Total|Total of all reporting groups
550850|NCT00136318|B2|Baseline|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550851|NCT00136318|B1|Baseline|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550852|NCT00136318|P2|Participant Flow|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550853|NCT00136318|P1|Participant Flow|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550854|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550855|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550856|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550857|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550858|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550859|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550860|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550861|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period,patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550862|NCT00136318|O2|Outcome|Placebo|"After the preobservation period, patients received placebo. After 2 weeks of antidepressant pretreatment, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of placebo.~Peginterferon alfa-2a :~Placebo :~Ribavirin :"
550863|NCT00136318|O1|Outcome|Escitalopram|"After the preobservation period, patients received escitalopram, 10 mg per day. During treatment period, all patients began receiving antiviral therapy with PEG-interferon plus ribavirin with continuous concomitant administration of escitalopram.~Peginterferon alfa-2a :~Escitalopram :~Ribavirin :"
550864|NCT00136318|E2|Reported Event|Placebo|
550865|NCT00136318|E1|Reported Event|Escitalopram|
550866|NCT00136084|B3|Baseline|Total|Total of all reporting groups
550867|NCT00136084|B2|Baseline|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
550868|NCT00136084|B1|Baseline|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
550869|NCT00136084|P2|Participant Flow|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
550870|NCT00136084|P1|Participant Flow|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
550871|NCT00136084|O1|Outcome|Overall|17 of the 232 eligible patients
550872|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (Ara-C) (LDAC)
550873|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (Ara-C) (HDAC)
550874|NCT00136084|O1|Outcome|Overall|Evaluation of all study participants
550875|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
550876|NCT00136084|O1|Outcome|Overall|Patients who have no response to one course of induction therapy
550877|NCT00136084|O1|Outcome|Overall|Post-GO Treatment MRD
550878|NCT00136084|O2|Outcome|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
550879|NCT00136084|O1|Outcome|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
550880|NCT00136084|E2|Reported Event|Arm 2:(LDAC)|Low-dose Cytarabine (LDAC)
550881|NCT00136084|E1|Reported Event|Arm 1: (HDAC)|High-dose Cytarabine (HDAC)
550882|NCT00135798|B4|Baseline|Total|Total of all reporting groups
550883|NCT00135798|B3|Baseline|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
550884|NCT00135798|B2|Baseline|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
550885|NCT00135798|B1|Baseline|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
550886|NCT00135798|P3|Participant Flow|LADR Treatment: Genotypes 2 or 3|Patients in this subgroup were all assigned to LADR treatment.
550887|NCT00135798|P2|Participant Flow|LADR Treatment: Genotypes 1, 4, 6|Low Accelerating Dose Regimen (LADR): Subjects randomized to LADR treatment group 2:1 compared to standard care.
550888|NCT00135798|P1|Participant Flow|Standard Clinical Care: Genotypes 1, 4, 6|Subjects randomized to non-treatment group 1:2 compared to treatment group.
550889|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
550890|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550891|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550892|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
550893|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550894|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550895|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
550896|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550897|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550898|NCT00135798|O3|Outcome|LADR Treatment Group: Genotypes 2, 3|All patients with Genotypes 2,3 received LADR treatment.
550899|NCT00135798|O2|Outcome|LADR Treatment Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550900|NCT00135798|O1|Outcome|Standard Care Group: Genotypes 1, 4, 6|Randomization 2:1 LADR vs. Standard care in Genotypes 1,4,6
550901|NCT00135798|E2|Reported Event|LADR Treatment (All Genotypes)|This group combines all who received LADR treatment (Per Protocol analysis) for all Genotypes 1,4,6 and 2,3
550902|NCT00135798|E1|Reported Event|Standard Clinical Care: Genotypes 1, 4, 6|Subjects who received no LADR treatment (Per Protocol analysis)
550903|NCT00135694|B4|Baseline|Total|Total of all reporting groups
550904|NCT00135694|B3|Baseline|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550905|NCT00135694|B2|Baseline|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550906|NCT00135694|B1|Baseline|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
550907|NCT00135694|P3|Participant Flow|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550908|NCT00135694|P2|Participant Flow|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550909|NCT00135694|P1|Participant Flow|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
550910|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550911|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550912|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550913|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550914|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550915|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550971|NCT00135330|B2|Baseline|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550916|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550917|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550918|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550919|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550920|NCT00135694|O1|Outcome|All Enrolled|Subjects who underwent liver transplantation in the trial.
550921|NCT00135694|O2|Outcome|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550922|NCT00135694|O1|Outcome|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550923|NCT00135694|E3|Reported Event|Randomized to Immunosuppression Maintenance|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression maintenance.
550924|NCT00135694|E2|Reported Event|Randomized to Immunosuppression Withdrawal|Subjects enrolled and transplanted into the trial and followed for at least one year and eligible for random assignment and randomized to immunosuppression withdrawal.
550925|NCT00135694|E1|Reported Event|Terminated Prior to Randomization|Subjects enrolled and transplanted into the trial but not eligible for randomization.
550926|NCT00135356|B3|Baseline|Total|Total of all reporting groups
550927|NCT00135356|B2|Baseline|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550928|NCT00135356|B1|Baseline|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550929|NCT00135356|P2|Participant Flow|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550930|NCT00135356|P1|Participant Flow|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550931|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550932|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550933|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550934|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550935|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550936|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550937|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550938|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550939|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550940|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550941|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550942|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550943|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
557678|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
550944|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550945|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550946|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550947|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550948|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550949|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550950|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550951|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550952|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550953|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550954|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550955|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550956|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550957|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550958|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550959|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550960|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550961|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550962|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550963|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550964|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550965|NCT00135356|O2|Outcome|PI/RTV Control Arm|Participants continued on their current treatment with an RTV-boosted, PI-containing HAART regimen while continuing their background NRTIs.
550966|NCT00135356|O1|Outcome|ATV/RTV Switch Arm|Participants switching their current treatment with a ritonavir (RTV)-boosted protease inhibitor (PI)-containing highly active antiretroviral therapy (HAART) regimen to atazanavir (ATV)/RTV (ATV: 2 x 150 mg capsules once daily (QD) / RTV: 1 x 100 mg capsule QD) while continuing their background nucleoside reverse transcriptase inhibitors (NRTIs).
550967|NCT00135356|E2|Reported Event|PI/RTV Control Arm|
550968|NCT00135356|E1|Reported Event|ATV/RTV Switch Arm|
550969|NCT00135330|B4|Baseline|Total|Total of all reporting groups
550970|NCT00135330|B3|Baseline|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550972|NCT00135330|B1|Baseline|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550973|NCT00135330|P3|Participant Flow|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550974|NCT00135330|P2|Participant Flow|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550975|NCT00135330|P1|Participant Flow|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550976|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550977|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550978|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550979|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550980|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550981|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550982|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550983|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550984|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550985|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550986|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550987|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550988|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550989|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550990|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550991|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550992|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550993|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550994|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550995|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550996|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
550997|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
550998|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
550999|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551000|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551001|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551002|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551003|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551004|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551005|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551006|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551007|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551008|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551009|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551010|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551011|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551012|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551013|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551014|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551015|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551016|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551017|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551018|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551019|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551020|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551021|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551022|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551023|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551024|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551025|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551026|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551027|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551028|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551029|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551030|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551031|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551032|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551033|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551034|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551035|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551036|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551037|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551038|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551039|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551040|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551041|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551042|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551043|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551044|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551045|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551046|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551047|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551048|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551049|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551050|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551051|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551052|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551053|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551054|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551055|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551056|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551057|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551058|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551059|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551060|NCT00135330|O3|Outcome|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551061|NCT00135330|O2|Outcome|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551062|NCT00135330|O1|Outcome|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551063|NCT00135330|E3|Reported Event|Rosiglitazone|Rosiglitazone 2 mg BID for 4-weeks followed by rosiglitazone 4 mgs BID for 16-weeks.
551253|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551064|NCT00135330|E2|Reported Event|Exenatide Plus Rosiglitazone|Exenatide 5 mcg BID + rosiglitazone 2 mg BID for 4-weeks followed by exenatide 10 mcg + rosiglitazone 4 mg BID for 16-weeks.
551065|NCT00135330|E1|Reported Event|Exenatide|Exenatide 5 mcg twice a day (BID) for 4-weeks followed by exenatide 10 mcg BID for 16-weeks.
551066|NCT00135200|B1|Baseline|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
551067|NCT00135200|P1|Participant Flow|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
551068|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
551069|NCT00135200|O1|Outcome|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
551070|NCT00135200|E1|Reported Event|Bexxar Therapeutic|"The Bexxar therapeutic regimen is delivered in two sets of intravenous infusions given 7-14 days apart. Nonradioactive Tositumomab is given before both the dosimetric infusion and the therapeutic infusion to improve distribution of these doses throughout the body. A trace amount of radioactive Iodine 131 Tositumomab is initially given to enable physicians to evaluate the clearance of radiation from the subject's body with gamma camera scans. Calculations made on the basis of these individualized radiation clearance rates allow the therapeutic dose (given 7-14 days after the dosimetric infusion) to be tailored for each patient. The therapeutic dose contains Tositumomab labeled with the amount of Iodine 131 tositumomab specifically calculated based on the scans performed following the dosimetric dose."
551071|NCT00134901|B3|Baseline|Total|Total of all reporting groups
551072|NCT00134901|B2|Baseline|Placebo|Placebo daily dose
551073|NCT00134901|B1|Baseline|Memantine|Memantine 40mg/day
551074|NCT00134901|P2|Participant Flow|Placebo|Placebo daily dose
551075|NCT00134901|P1|Participant Flow|Memantine|Memantine 40mg/day
551076|NCT00134901|O2|Outcome|Placebo|"Placebo~placebo: placebo"
551077|NCT00134901|O1|Outcome|Memantine|"Memantine~Memantine: Memantine"
551078|NCT00134901|O2|Outcome|Placebo|Placebo daily dose
551079|NCT00134901|O1|Outcome|Memantine|Memantine 40mg/day
551080|NCT00134901|E2|Reported Event|Placebo|Placebo daily dose
551081|NCT00134901|E1|Reported Event|Memantine|Memantine 40mg/day
551082|NCT00134784|B5|Baseline|Total|Total of all reporting groups
551083|NCT00134784|B4|Baseline|Levodopa 600 mg/Day|Subjects on Levodopa 600 mg/day
551084|NCT00134784|B3|Baseline|Levodopa 300 mg/Day|Subjects on 300 mg/day of Levodopa
551085|NCT00134784|B2|Baseline|Levodopa 150mg/Day|Subjects on 150mg/day of Levodopa
551086|NCT00134784|B1|Baseline|Placebo Group|Subjects on placebo
551087|NCT00134784|P4|Participant Flow|Levodopa 600 mg/Day|Levodopa 600/day, [123I]ß-CIT and SPECT imaging
551088|NCT00134784|P3|Participant Flow|Levodopa 300 mg/Day|Levodopa 300mg/day, [123I]ß-CIT and SPECT imaging
551089|NCT00134784|P2|Participant Flow|Levodopa 150mg/Day|Levodopa 150mg/day, [123I]ß-CIT and SPECT imaging
551090|NCT00134784|P1|Participant Flow|Placebo|Placebo group
551091|NCT00134784|O4|Outcome|Levodopa 3|Subjects on 600 mg/day of Levodopa
551092|NCT00134784|O3|Outcome|Levodopa 2|Subjects on 300 mg/day of Levodopa
551093|NCT00134784|O2|Outcome|Levodopa|Subjects on 150 mg/day of Levodopa
551094|NCT00134784|O1|Outcome|Placebo Group|Participants receiving placebo
551095|NCT00134784|E1|Reported Event|I123BCIT|[123I]ß CIT and SPECT imaging' .
551096|NCT00134719|B4|Baseline|Total|Total of all reporting groups
551097|NCT00134719|B3|Baseline|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551098|NCT00134719|B2|Baseline|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551099|NCT00134719|B1|Baseline|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551100|NCT00134719|P3|Participant Flow|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551101|NCT00134719|P2|Participant Flow|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551102|NCT00134719|P1|Participant Flow|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551103|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551104|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551105|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551106|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551107|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551108|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551109|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551110|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551111|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551112|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551113|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551114|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551115|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551116|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551117|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551118|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551119|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551120|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551121|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551122|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551123|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551124|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551125|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551126|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551127|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551128|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551129|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551130|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551131|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551132|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551133|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551134|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551135|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551136|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551137|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551138|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551139|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551140|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551141|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551142|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551143|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551144|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551145|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551146|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551147|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551148|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551149|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551150|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551151|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551152|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551153|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551154|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551155|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551156|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551157|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551158|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551159|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551160|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551161|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551162|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551163|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551164|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551165|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551166|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551167|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551168|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551169|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551170|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551171|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551172|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551173|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551174|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551175|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551176|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551177|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551178|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551179|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551180|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551181|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551182|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551183|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551184|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551185|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551186|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551187|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551188|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551189|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551190|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551191|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551192|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551193|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551194|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551195|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551196|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551197|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551198|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551199|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551200|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551201|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551202|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551203|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551204|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551205|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551206|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551207|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551208|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551209|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551210|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551211|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551212|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551213|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551214|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551215|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551216|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551217|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551218|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551219|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551220|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551221|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551222|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551223|NCT00134719|O3|Outcome|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551224|NCT00134719|O2|Outcome|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551225|NCT00134719|O1|Outcome|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551226|NCT00134719|E3|Reported Event|ActHIB/PedvaxHIB Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta and Prevenar vaccines and receiving a dose of PedvaxHIB co-administered with M-M-RII and Varivax vaccines in study 102371.
551227|NCT00134719|E2|Reported Event|ActHIB + Meningitec Group|Subjects primed in study 102370 with 3 doses of ActHIB, Infanrix Penta, Prevenar and Meningitec vaccines and receiving a dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551228|NCT00134719|E1|Reported Event|MenHibrix Group|Subjects primed in study 102370 with 3 doses of MenHibrix, Infanrix Penta and Prevenar vaccines and receiving a fourth dose of MenHibrix co-administered with M-M-RII and Varivax vaccines in study 102371.
551229|NCT00134563|B4|Baseline|Total|Total of all reporting groups
551230|NCT00134563|B3|Baseline|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551231|NCT00134563|B2|Baseline|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551232|NCT00134563|B1|Baseline|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551233|NCT00134563|P3|Participant Flow|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551234|NCT00134563|P2|Participant Flow|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551235|NCT00134563|P1|Participant Flow|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551236|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551237|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551238|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551239|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551240|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551241|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551242|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551243|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551244|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551245|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551246|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551247|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551248|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551249|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551250|NCT00134563|O1|Outcome|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551251|NCT00134563|O3|Outcome|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551252|NCT00134563|O2|Outcome|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551254|NCT00134563|E3|Reported Event|Teriflunomide 14 mg|Teriflunomide 14 mg once daily for 108 weeks
551255|NCT00134563|E2|Reported Event|Teriflunomide 7 mg|Teriflunomide 7 mg once daily for 108 weeks
551256|NCT00134563|E1|Reported Event|Placebo|Placebo (for teriflunomide) once daily for 108 weeks
551257|NCT00134043|B3|Baseline|Total|Total of all reporting groups
551258|NCT00134043|B2|Baseline|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551259|NCT00134043|B1|Baseline|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551260|NCT00134043|P2|Participant Flow|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551261|NCT00134043|P1|Participant Flow|DTCs (Well-differentiated Thyroid Carcinomas)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551262|NCT00134043|O2|Outcome|MTC (Medullary Thyroid Cancer)|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551263|NCT00134043|O1|Outcome|DTCs (Well-differentiated Thyroid Carcinomas)|Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.
551264|NCT00134043|E1|Reported Event|Arm I & Arm II|"Patients receive oral suberoylanilide hydroxamic acid (SAHA) twice daily on days 1-14. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients are then evaluated for disease response. Patients achieving a complete response receive an additional 2 courses of SAHA. Patients achieving stable disease or a partial response receive 4 additional courses of SAHA.After completion of study treatment, patients are followed within 4 weeks.~vorinostat: Given orally"
551265|NCT00134004|B1|Baseline|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551266|NCT00134004|P1|Participant Flow|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551267|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551268|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551269|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551270|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551271|NCT00134004|O1|Outcome|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551272|NCT00134004|E1|Reported Event|Mini-haplo BMT|Non-myeloablative haploidentical bone marrow transplant with a fludarabine, cyclophosphamide (Cy), TBI (total body irradiation) preparative regimen and post-transplant Cy, mycophenolate mofetil (MMF), and tacrolimus as GVHD prophylaxis.
551273|NCT00133978|B5|Baseline|Total|Total of all reporting groups
551274|NCT00133978|B4|Baseline|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551275|NCT00133978|B3|Baseline|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
551276|NCT00133978|B2|Baseline|Antioxidants|Antioxidant supplementation
551277|NCT00133978|B1|Baseline|Glutamine|Glutamine supplementation
551278|NCT00133978|P4|Participant Flow|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551494|NCT00132808|E2|Reported Event|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551279|NCT00133978|P3|Participant Flow|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously , and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
551280|NCT00133978|P2|Participant Flow|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously, and the following vitamins and minerals enterally-- selenium 300 g, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
551281|NCT00133978|P1|Participant Flow|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
551282|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551283|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
551284|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
551285|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
551286|NCT00133978|O4|Outcome|No Antioxidants|Non-isonitrogenic, iso-caloric placebo solution
551287|NCT00133978|O3|Outcome|Antioxidants|500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
551288|NCT00133978|O2|Outcome|No Glutamine|Non-isonitrogenic, iso-caloric placebo solution
551289|NCT00133978|O1|Outcome|Glutamine|0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
551290|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551291|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
551292|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
551293|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
551294|NCT00133978|O4|Outcome|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551295|NCT00133978|O3|Outcome|Glutamine + Antioxidants|Glutamine and antioxidant supplementation
551296|NCT00133978|O2|Outcome|Antioxidants|Antioxidant supplementation
551297|NCT00133978|O1|Outcome|Glutamine|Glutamine supplementation
551298|NCT00133978|E4|Reported Event|Placebo|Non-isonitrogenic, iso-caloric placebo solution
551299|NCT00133978|E3|Reported Event|Glutamine + Antioxidants|"Glutamine and antioxidant supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.~500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg."
551300|NCT00133978|E2|Reported Event|Antioxidants|Antioxidant supplementation 500 ug of selenium intravenously and the following vitamins and minerals enterally-- selenium 300 ug, zinc 20 mg, beta carotene 10 mg, vitamin E 500 mg, and vitamin C 1500 mg.
551301|NCT00133978|E1|Reported Event|Glutamine|Glutamine supplementation 0.35 g/kg/day of glutamine intravenously based on ideal body weight, provided as 0.50 g/kg/day of the dipeptide alanyl-glutamine and 30 g/day enterally, provided as alanyl-glutamine and glycine-glutamine dipeptides.
551302|NCT00133952|B3|Baseline|Total|Total of all reporting groups
551303|NCT00133952|B2|Baseline|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551304|NCT00133952|B1|Baseline|Placebo|Taken orally daily for up to 48 months
551305|NCT00133952|P2|Participant Flow|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551306|NCT00133952|P1|Participant Flow|Placebo|Taken orally daily for up to 48 months
551307|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551308|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551309|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551310|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551311|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551312|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551313|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551314|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551315|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551316|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551317|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551318|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551319|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551320|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551321|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551322|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551323|NCT00133952|O2|Outcome|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551324|NCT00133952|O1|Outcome|Placebo|Taken orally daily for up to 48 months
551325|NCT00133952|E2|Reported Event|Ruboxistaurin|32 milligrams (mg) taken orally daily for up to 48 months
551326|NCT00133952|E1|Reported Event|Placebo|Taken orally daily for up to 48 months
551327|NCT00133809|B1|Baseline|Islet Transplant|"10 subjects were found eligible and were can be matched to an appropriate donor will receive/have received an islet transplant---1 INELIGIBLE WHILE ON WAITLIST.~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551365|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
557679|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
551328|NCT00133809|P1|Participant Flow|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551329|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551330|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551331|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551332|NCT00133809|O1|Outcome|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551333|NCT00133809|E1|Reported Event|Islet Transplant|"All subjects who are found eligible and who can be matched to an appropriate donor will receive/have received an islet transplant~Transplantation of Human Islets: Human islets, at least 9,000 islet equivalents per kilogram of body weight. Transplant involves surgical procedure"
551334|NCT00133705|B3|Baseline|Total|Total of all reporting groups
551335|NCT00133705|B2|Baseline|Placebo|Twenty women received a placebo pill daily.
551336|NCT00133705|B1|Baseline|Mifepristone 5 mg.|Twenty-two women received 5 mg. mifepristone daily.
551337|NCT00133705|P2|Participant Flow|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
551338|NCT00133705|P1|Participant Flow|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
551339|NCT00133705|O2|Outcome|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
551340|NCT00133705|O1|Outcome|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
551341|NCT00133705|E2|Reported Event|Placebo Group|These women received placebo capsules identical in appearance and weight to the 5 mg. mifepristone capsule to be taken once daily.
551342|NCT00133705|E1|Reported Event|Treatment Group|This group will receive 5 mg. capsules to be taken once daily.
551343|NCT00133575|B8|Baseline|Total|Total of all reporting groups
551344|NCT00133575|B7|Baseline|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551345|NCT00133575|B6|Baseline|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551346|NCT00133575|B5|Baseline|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551347|NCT00133575|B4|Baseline|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551348|NCT00133575|B3|Baseline|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551349|NCT00133575|B2|Baseline|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551350|NCT00133575|B1|Baseline|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551351|NCT00133575|P7|Participant Flow|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551352|NCT00133575|P6|Participant Flow|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551353|NCT00133575|P5|Participant Flow|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551354|NCT00133575|P4|Participant Flow|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551355|NCT00133575|P3|Participant Flow|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551356|NCT00133575|P2|Participant Flow|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551357|NCT00133575|P1|Participant Flow|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551358|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551359|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551360|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551361|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551362|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551363|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551364|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
557680|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
551366|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551367|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551368|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551369|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551370|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551371|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551372|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551373|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551374|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551375|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551376|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551377|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551378|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551379|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551380|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551381|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551382|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551383|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551384|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551385|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551386|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551387|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551388|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551389|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551390|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551391|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551392|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551393|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551394|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551395|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551396|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551397|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551398|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551399|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551400|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551401|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551402|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551403|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551404|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
557681|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
551405|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551406|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551407|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551408|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551409|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551410|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551411|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551412|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551413|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551414|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551415|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551416|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551417|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551418|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551419|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551420|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551421|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551422|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551423|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551424|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551425|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551426|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551427|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551428|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551429|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551430|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551431|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551432|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551433|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551434|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551435|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551436|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551437|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551438|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551439|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551440|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551441|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551442|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551443|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
552290|NCT00129220|B1|Baseline|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
551444|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551445|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551446|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551447|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551448|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551449|NCT00133575|O7|Outcome|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551450|NCT00133575|O6|Outcome|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551451|NCT00133575|O5|Outcome|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551452|NCT00133575|O4|Outcome|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551453|NCT00133575|O3|Outcome|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551454|NCT00133575|O2|Outcome|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551455|NCT00133575|O1|Outcome|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551456|NCT00133575|E7|Reported Event|Saline Placebo|Saline placebo via intradermal (ID), intramuscular (IM) or subcutaneous (SC) route at days 0 and 28
551457|NCT00133575|E6|Reported Event|10^8 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551458|NCT00133575|E5|Reported Event|10^7 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551459|NCT00133575|E4|Reported Event|10^8 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^8 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551460|NCT00133575|E3|Reported Event|10^7 TCID50 MVA SC|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via subcutaneous (SC) route on days 0 and 28
551461|NCT00133575|E2|Reported Event|10^7 TCID50 MVA IM|ACAM3000 Modified Vaccinia Ankara dose 10^7 tissue culture infectious dose 50 (TCID50) via intramuscular (IM) route on days 0 and 28
551462|NCT00133575|E1|Reported Event|10^6 TCID50 MVA ID|ACAM3000 Modified Vaccinia Ankara dose 10^6 tissue culture infectious dose 50 (TCID50) via intradermal (ID) route on days 0 and 28
551463|NCT00132873|B1|Baseline|Xyrem (Sodium Oxybate)|
551464|NCT00132873|P1|Participant Flow|Xyrem (Sodium Oxybate)|
551465|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
551466|NCT00132873|O1|Outcome|Xyrem (Sodium Oxybate)|
551467|NCT00132873|E1|Reported Event|Xyrem (Sodium Oxybate)|
551468|NCT00132808|B4|Baseline|Total|Total of all reporting groups
551469|NCT00132808|B3|Baseline|Placebo|Placebo given at randomization and Month 12
551470|NCT00132808|B2|Baseline|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551471|NCT00132808|B1|Baseline|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551472|NCT00132808|P3|Participant Flow|Placebo|Placebo given at randomization and Month 12
551473|NCT00132808|P2|Participant Flow|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551474|NCT00132808|P1|Participant Flow|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551475|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551476|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551477|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551478|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551479|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551480|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551481|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551482|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551483|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551484|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551485|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551486|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551487|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551488|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551489|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551490|NCT00132808|O3|Outcome|Placebo|Placebo given at randomization and Month 12
551491|NCT00132808|O2|Outcome|Zoledronic Acid 1x5 mg|Zoledronic acid 5 mg i.v. given at randomization and placebo at Month 12
551492|NCT00132808|O1|Outcome|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551493|NCT00132808|E3|Reported Event|Placebo|Placebo given at randomization and Month 12
555697|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
551495|NCT00132808|E1|Reported Event|Zoledronic Acid 2x5 mg|Zoledronic acid 5 mg intravenous (i.v.) given at randomization and Month 12
551496|NCT00132769|B3|Baseline|Total|Total of all reporting groups
551497|NCT00132769|B2|Baseline|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551498|NCT00132769|B1|Baseline|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551499|NCT00132769|P2|Participant Flow|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551500|NCT00132769|P1|Participant Flow|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551501|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551502|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551503|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551504|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551505|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551506|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551507|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551508|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551509|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551510|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551511|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551512|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551513|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551514|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551515|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551516|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551517|NCT00132769|O2|Outcome|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551518|NCT00132769|O1|Outcome|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551519|NCT00132769|E2|Reported Event|Placebo|Participants receive matching placebo to MK-0873 twice daily for 12 weeks
551520|NCT00132769|E1|Reported Event|MK-0873|Participants receive MK-0873 1.25 mg twice daily for 12 weeks
551521|NCT00132730|B5|Baseline|Total|Total of all reporting groups
551522|NCT00132730|B4|Baseline|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551523|NCT00132730|B3|Baseline|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551524|NCT00132730|B2|Baseline|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551525|NCT00132730|B1|Baseline|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551526|NCT00132730|P6|Participant Flow|Usual Care|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
551527|NCT00132730|P5|Participant Flow|MK-0873 2.5 mg + Usual Care|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
551528|NCT00132730|P4|Participant Flow|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551529|NCT00132730|P3|Participant Flow|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551530|NCT00132730|P2|Participant Flow|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
551531|NCT00132730|P1|Participant Flow|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
551532|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551533|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551534|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551535|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551536|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
557682|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
551537|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551538|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551539|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551540|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551541|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551542|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551543|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551544|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551545|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551546|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551547|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551548|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551549|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551550|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551551|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551552|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551553|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551554|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551555|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551556|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551557|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551558|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551559|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551560|NCT00132730|O4|Outcome|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551561|NCT00132730|O3|Outcome|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551562|NCT00132730|O2|Outcome|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551687|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
557683|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
551563|NCT00132730|O1|Outcome|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551564|NCT00132730|E8|Reported Event|Usual Care EXT2|Participants receive usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
551565|NCT00132730|E7|Reported Event|MK-0873 2.5 mg + Usual Care EXT 2|Participants receive MK-0873 2.5 mg tablets once daily plus usual care (inhaled short- or long-acting beta-agonists, inhaled corticosteroids, or short- or long-acting anticholinergics) for 28 weeks in Periods IV and V (EXT2)
551566|NCT00132730|E6|Reported Event|Placebo EXT 1|Participants receive placebo tablets once daily for 12 weeks in Period III (EXT1)
551567|NCT00132730|E5|Reported Event|MK-0873 2.5 mg EXT 1|Participants receive MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551568|NCT00132730|E4|Reported Event|Placebo Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), placebo tablets once daily for 12 weeks in Period II (Base) and placebo tablets once daily for 12 weeks in Period III (EXT1)
551569|NCT00132730|E3|Reported Event|MK-0873 2.5 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), MK-0873 2.5 mg tablets once daily for 12 weeks in Period II (Base) and MK-0873 2.5 mg tablets once daily for 12 weeks in Period III (EXT1)
551570|NCT00132730|E2|Reported Event|MK-0873 1.25 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 1.25 mg tablets once daily for 12 weeks in Period II (Base)
551571|NCT00132730|E1|Reported Event|MK-0873 0.75 mg Base Study|Participants receive placebo tablets once daily for 3 weeks in Period I (Base), and MK-0873 0.75 mg tablets once daily for 12 weeks in Period II (Base)
551572|NCT00132691|B3|Baseline|Total|Total of all reporting groups
551573|NCT00132691|B2|Baseline|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
551574|NCT00132691|B1|Baseline|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
551575|NCT00132691|P2|Participant Flow|Standard Systemic Treatment|Systemic corticosteroid therapy with immunosuppression as indicated
551576|NCT00132691|P1|Participant Flow|Flucinolone Acetonide Intraocular Implant|Local therapy with fluocinolone acetonide 0.59 mg implant (Retisert; Bausch & Lomb Inc.) in each eye with uveitis of sufficient severity to justify treatment with systemic corticosteroids
551577|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551578|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551579|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551580|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551581|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551582|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551583|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551584|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551585|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551586|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551587|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551588|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551589|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551590|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
551591|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551592|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
551593|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551594|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551595|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551596|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy
551597|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551598|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
551599|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551600|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
551601|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551602|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551603|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551604|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551605|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy
551606|NCT00132691|O1|Outcome|Fluocinolone Acetonide Implant|Participants randomized to receive implant therapy
551607|NCT00132691|O2|Outcome|Systemic Therapy|Participants randomized to receive systemic therapy.
551608|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551688|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551689|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
555698|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
551609|NCT00132691|O2|Outcome|Systemic Therapy|Oral corticosteroids supplemented with immunosuppressive drugs if indicated were given according to published guidelines developed by an expert panel. For participants with active uveitis at baseline, 1 mg/kg/day up to 60 mg/day of prednisone was given until uveitis was controlled or 4 weeks had elapsed. When control was achieved, prednisone was tapered per study guidelines. Immunosuppressive drugs were added when uveitis was not initially controlled with prednisone alone, as corticosteroid-sparing agents when prednisone could not be tapered to 10 mg/day without reactivation of uveitis and for specific uveitis syndromes. Choice of immunosuppressant was made by the study ophthalmologist; immunosuppressant administration and monitoring for toxicity was conducted according to expert guidelines.
551610|NCT00132691|O1|Outcome|Flucinolone Acetonide Implant|A fluocinolone acetonide intravitreal implant (0.59 mg) was surgically placed by a study-certified surgeon was placed in each eligible eye. The first eye was implanted within 28 days of randomization and, if eligible, the second eye within the next 28 days. Prior to implant surgery, topical, periocular or systemic corticosteroids where used as needed to quiet the anterior chamber. Post-implant, systemic corticosteroids and immunosuppressive drugs were tapered and discontinued. If the second eye was not eligible for an implant initially but later became eligible, an implant was placed in the second eye at that time. The treatment algorithm included re-implantation upon reactivation and treatment per best medical judgment for failure to achieve inflammation control, treatment-limiting toxicity and systemic disease requiring systemic therapy.
551611|NCT00132691|E2|Reported Event|Systemic Therapy|Participants randomized to receive systemic therapy.
551612|NCT00132691|E1|Reported Event|Flucinolone Acetonide Implant|Participants randomized to receive implant therapy.
551613|NCT00132678|B3|Baseline|Total|Total of all reporting groups
551614|NCT00132678|B2|Baseline|Placebo|IM injection every 2 weeks
551615|NCT00132678|B1|Baseline|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
551616|NCT00132678|P3|Participant Flow|Open-Label Oral Risperidone|(flexible dosage) 1 to 6 mg/day for the first 3 weeks
551617|NCT00132678|P2|Participant Flow|Placebo|intramuscular (IM) injection every 2 weeks
551618|NCT00132678|P1|Participant Flow|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks
551619|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
551620|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
551621|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
551622|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
551623|NCT00132678|O2|Outcome|Placebo|IM injection every 2 weeks
551624|NCT00132678|O1|Outcome|RISPERDAL CONSTA|risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg IM injection every 2 weeks
551625|NCT00132678|E4|Reported Event|Open Label RISPERDAL CONSTA|Open-label Period III. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
551626|NCT00132678|E3|Reported Event|Open-Label Oral Risperidone|Open-label Period II. Flexible dosage. 1 to 6 mg/day for the first 3 weeks
551627|NCT00132678|E2|Reported Event|Placebo|Double-blind Period IV. Intramuscular (IM) injection every 2 weeks
551628|NCT00132678|E1|Reported Event|RISPERDAL CONSTA|Double-blind Period IV. Risperidone long acting injectable (RIS LAI) 12.5, 25, 37.5 or 50 mg intramuscular (IM) injection every 2 weeks.
551629|NCT00132496|B3|Baseline|Total|Total of all reporting groups
551630|NCT00132496|B2|Baseline|Rabeprazole 20 mg|once daily for 8 weeks
551631|NCT00132496|B1|Baseline|Rabeprazole 10 mg|once daily for 8 weeks
551632|NCT00132496|P2|Participant Flow|Rabeprazole 20 mg|once daily for 8 weeks
551633|NCT00132496|P1|Participant Flow|Rabeprazole 10 mg|once daily for 8 weeks
551634|NCT00132496|O2|Outcome|Rabeprazole 20 mg|once daily for 8 weeks
551635|NCT00132496|O1|Outcome|Rabeprazole 10 mg|once daily for 8 weeks
551636|NCT00132496|E2|Reported Event|Rabeprazole 20 mg|once daily for 8 weeks
551637|NCT00132496|E1|Reported Event|Rabeprazole 10 mg|once daily for 8 weeks
551638|NCT00132314|B3|Baseline|Total|Total of all reporting groups
551639|NCT00132314|B2|Baseline|Oral Antipsychotic|oral antipsychotic medication
551640|NCT00132314|B1|Baseline|Injectable Risperidone|long-acting injectable risperidone
551641|NCT00132314|P2|Participant Flow|Oral Antipsychotic|oral antipsychotic medication
551642|NCT00132314|P1|Participant Flow|Injectable Risperidone|long-acting injectable risperidone
551643|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
551644|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
551645|NCT00132314|O2|Outcome|Oral Antipsychotic|oral antipsychotic medication
551646|NCT00132314|O1|Outcome|Injectable Risperidone|long-acting injectable risperidone
551647|NCT00132314|E2|Reported Event|Oral Antipsychotic|oral antipsychotic medication
551648|NCT00132314|E1|Reported Event|Injectable Risperidone|long-acting injectable risperidone
551649|NCT00132132|B3|Baseline|Total|Total of all reporting groups
551650|NCT00132132|B2|Baseline|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
551651|NCT00132132|B1|Baseline|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
551652|NCT00132132|P2|Participant Flow|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
551690|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551691|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
558214|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
551653|NCT00132132|P1|Participant Flow|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
551654|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
551655|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
551656|NCT00132132|O2|Outcome|Standard of Care/Control Group|The Standard of Care/Control group received visits to primary care provider and referral to nutritionist
551657|NCT00132132|O1|Outcome|Intervention Group|The intervention group attended monthly, 4 hour sessions for one year
551658|NCT00132132|E2|Reported Event|Standard of Care/Control|Standard of Care/control group received visits to the primary care provider and a referral to a nutritionist
551659|NCT00132132|E1|Reported Event|Behavioral Program|This is a long term randomized controlled study looking at the effect of a Behavioral program on BMI in a population 10-20years old with a BMI greater than or equal to 85%. The intervention group attends a monthly 4 hour session which incorporates exercise, education, empowerment and incentives. Both groups are referred to a dietician. The primary outcome is change in BMI and the secondary outcome is improvement in fasting metabolic parameters (lipid panel, insulin, glucose).
551660|NCT00132028|B1|Baseline|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
551661|NCT00132028|P1|Participant Flow|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
551662|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
551663|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
551664|NCT00132028|O1|Outcome|SAHA (Vorinostat)|Patients receive vorinostat 400 mg/day on days 1-14 of every 21-day cycle. Patients continue treatment until progression.
551665|NCT00132028|E1|Reported Event|SAHA (Vorinostat)|
551666|NCT00132002|B1|Baseline|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551667|NCT00132002|P1|Participant Flow|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551668|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551669|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551670|NCT00132002|O1|Outcome|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551671|NCT00132002|E1|Reported Event|Arm 1|Vorinostat, 200 mg orally twice daily, was administered for the first 14 days of each 21 day cycle. Treatment was continued unless either disease progression was determined, the patient requested to be withdrawn from the study, or excessive toxicity was noted.
551672|NCT00131937|B1|Baseline|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
551673|NCT00131937|P1|Participant Flow|Treatment (Sorafenib)|"Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
551674|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
551675|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
551676|NCT00131937|O1|Outcome|Treatment (Sorafenib)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally"
551677|NCT00131937|E1|Reported Event|Treatment (Sorafenib)|All patients who received Sorafenib treatment.
551678|NCT00131911|B3|Baseline|Total|Total of all reporting groups
551679|NCT00131911|B2|Baseline|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551680|NCT00131911|B1|Baseline|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551681|NCT00131911|P2|Participant Flow|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551682|NCT00131911|P1|Participant Flow|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551683|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551684|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551685|NCT00131911|O2|Outcome|Group B (Islet Cell and Other Neuroendocrine Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551686|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551692|NCT00131911|O1|Outcome|Group A (Patients With Carcinoid Tumors)|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551693|NCT00131911|E1|Reported Event|All Patients|Patients receive 400 mg oral sorafenib twice daily on days 1-28.
551694|NCT00131885|B5|Baseline|Total|Total of all reporting groups
551695|NCT00131885|B4|Baseline|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551696|NCT00131885|B3|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551697|NCT00131885|B2|Baseline|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551698|NCT00131885|B1|Baseline|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551699|NCT00131885|P4|Participant Flow|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551700|NCT00131885|P3|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551701|NCT00131885|P2|Participant Flow|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551702|NCT00131885|P1|Participant Flow|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551703|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551704|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551705|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551706|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551707|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551708|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551709|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551710|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551711|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551712|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551713|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551714|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551715|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551801|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551802|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551716|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551717|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551718|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551719|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551720|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551721|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551722|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551723|NCT00131885|O4|Outcome|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551724|NCT00131885|O3|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551725|NCT00131885|O2|Outcome|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551726|NCT00131885|O1|Outcome|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551727|NCT00131885|E4|Reported Event|LNG 1.5 mg Dose, Then SJW 1500 ng Day, 1.5 mg LNG|Group 4: A one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, then St. John’s Wort 300 mg orally five times per day (total 1500 mg daily) and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551728|NCT00131885|E3|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Daily, 2.25 mg LNG Dose|Group 3: A one-time oral dose of levonorgestrel 1.5 mg mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day (900 mg total) and a one-time oral dose of levonorgestrel 2.25 mg at the second pharmacokinetic study
551729|NCT00131885|E2|Reported Event|LNG 1.5 mg Dose, Then SJW 900 mg Day, LNG 1.5 mg|Group 2: One-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by St. John’s Wort 300 mg orally three times per day, and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551730|NCT00131885|E1|Reported Event|LNG 1.5 mg Dose, Then Placebo Herb, LNG 1.5 mg|Group 1: one-time oral dose of levonorgestrel 1.5 mg at the first pharmacokinetic study, followed by placebo herb and a one-time oral dose of levonorgestrel 1.5 mg at the second pharmacokinetic study
551731|NCT00131677|B3|Baseline|Total|Total of all reporting groups
551732|NCT00131677|B2|Baseline|Placebo|Placebo arm--received matching placebo
551733|NCT00131677|B1|Baseline|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
551734|NCT00131677|P2|Participant Flow|Placebo|Participants received matching placebo, to be taken daily.
551735|NCT00131677|P1|Participant Flow|Tenofovir Disoproxil Fumarate|Participants received TDF 300mg orally daily for 24 months (immediate arm) or 15 months (delayed arm).
551736|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
551737|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
551738|NCT00131677|O2|Outcome|Placebo|Placebo arm--received matching placebo
551739|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
551740|NCT00131677|O1|Outcome|All Enrolled Participants|
551741|NCT00131677|O1|Outcome|Treatment Emergent Cohort|Includes all who entered treatment emergent cohort (active and placebo arms)
551742|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
551743|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily.
551744|NCT00131677|O2|Outcome|Placebo|Matching placebo daily
551745|NCT00131677|O1|Outcome|Tenofovir Disoproxil Fumarate|TDF, 300 mg orally daily
551746|NCT00131677|E2|Reported Event|Placebo|Matching placebo daily
551747|NCT00131677|E1|Reported Event|Tenofovir Disoproxil Fumarate|Active arm: assigned to take TDF, 300mg po daily.
551748|NCT00131664|B4|Baseline|Total|Total of all reporting groups
551749|NCT00131664|B3|Baseline|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551750|NCT00131664|B2|Baseline|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551751|NCT00131664|B1|Baseline|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551803|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
558215|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
551752|NCT00131664|P6|Participant Flow|Metformin and Amaryl|Metformin Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months.
551753|NCT00131664|P5|Participant Flow|Avandamet and Amaryl|Avandamet™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Amaryl™ was added and titrated up to 4 mg once daily maximum dose for an additional 6 months
551754|NCT00131664|P4|Participant Flow|Avandia, Amaryl and Metformin|Avandia™ + Amaryl™ Arm: At month 6, if patients not achieving A1C target of less than 7 received additional specified drug therapy. Metformin was added and titrated up to 1000 mg twice daily (BID) maximum dose for an additional 6 months.
551755|NCT00131664|P3|Participant Flow|Metformin|Metformin Arm: initial dose of 500 mg twice daily (BID) was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID.
551756|NCT00131664|P2|Participant Flow|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg twice daily (BID) was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID.
551757|NCT00131664|P1|Participant Flow|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg + 1 mg once daily (OD) was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg + 2 mg OD.
551758|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551759|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551760|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551761|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551762|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551763|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551764|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551765|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551766|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551767|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551768|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551769|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551770|NCT00131664|O3|Outcome|Metformin|: 500 mg twice daily titration up to 1000 mg twice daily over 6 months
551771|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551772|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551773|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551774|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551775|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551776|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551777|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551778|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551779|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551780|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551781|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551782|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551783|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551784|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551785|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551786|NCT00131664|O2|Outcome|Avandamet|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551787|NCT00131664|O1|Outcome|Avandia and Amaryl|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551788|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551789|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551790|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551791|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551792|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551793|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551794|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551795|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551796|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551797|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551798|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551799|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551800|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551804|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551805|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551806|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551807|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551808|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551809|NCT00131664|O3|Outcome|Metformin|500 mg twice daily titration up to 1000 mg twice daily over 6 months
551810|NCT00131664|O2|Outcome|Avandamet|2 mg / 500 mg twice daily titration up to 4 mg / 1000 mg twice daily over 6 months
551811|NCT00131664|O1|Outcome|Avandia and Amaryl|4 mg + 1 mg once daily titration up to 8 mg + 2 mg once daily over 6 months
551812|NCT00131664|E3|Reported Event|Metformin|Metformin Arm: initial dose of 500 mg BID was titrated up to 850 mg BID at month 2. At month 4, it was further titrated up to 1000 mg BID. At month 6 (visit 6), patients not achieving target received additional specified drug therapy: Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months.
551813|NCT00131664|E2|Reported Event|Avandamet|Avandamet™ Arm: at month 2 the initial dose of 2 mg / 500 mg BID was titrated up to 4 mg / 500 mg BID; at month 4 it was be further titrated up to 4 mg / 1000 mg BID. At month 6, patients not achieving target received additional specified drug therapy Amaryl™ was added and titrated up to 4 mg OD maximum dose for an additional 6 months
551814|NCT00131664|E1|Reported Event|Avandia and Amaryl|Avandia™ + Amaryl™ Arm: at month 2 initial dose of 4 mg +1 mg OD was titrated up to 8 mg + 1 mg OD; at month 4 it was further titrated up to 8 mg / 2 mg OD. At month 6, patients not achieving target received additional specified drug therapy: Metformin was added and titrated up to 1000 mg BID maximum dose for an additional 6 months.
551815|NCT00131573|B3|Baseline|Total|Total of all reporting groups
551816|NCT00131573|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
551817|NCT00131573|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
551818|NCT00131573|P2|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
551819|NCT00131573|P1|Participant Flow|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
551820|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
551821|NCT00131573|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
551822|NCT00131573|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
551823|NCT00131573|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
551824|NCT00131573|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
551825|NCT00131573|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
551826|NCT00131508|B3|Baseline|Total|Total of all reporting groups
551827|NCT00131508|B2|Baseline|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551828|NCT00131508|B1|Baseline|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551829|NCT00131508|P2|Participant Flow|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551830|NCT00131508|P1|Participant Flow|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551831|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551832|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551833|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551834|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551835|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551836|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551837|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551838|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551839|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551840|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551841|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551842|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551843|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551844|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551845|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551846|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551847|NCT00131508|O2|Outcome|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551848|NCT00131508|O1|Outcome|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551849|NCT00131508|E2|Reported Event|Glutamine|Glutamine dosage of 0.60 gm/kg body weight per day divided into two doses.
551850|NCT00131508|E1|Reported Event|Placebo|A mixture of non-essential amino acids containing glycine, alanine, and serine.
551851|NCT00131456|B3|Baseline|Total|Total of all reporting groups
551852|NCT00131456|B2|Baseline|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
551853|NCT00131456|B1|Baseline|Placebo|Matched Placebo
551854|NCT00131456|P2|Participant Flow|Venlafaxine|"Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (very much improved') and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day."
551855|NCT00131456|P1|Participant Flow|Placebo|Matched Placebo
551856|NCT00131456|O2|Outcome|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
551857|NCT00131456|O1|Outcome|Placebo|Matched Placebo
551858|NCT00131456|E2|Reported Event|Venlafaxine|Venlafaxine: VEN-XR was titrated to the target dose of 225 mg/day (or the maximum tolerated dose) over the three weeks after randomization. After the fourth week post-randomization, patients with persistent depression who were not rated as having a CGI-Depression score of 1 (“very much improved’) and who were tolerating 225 mg/day had their dose increased to a maximum of 375 mg/day.
551859|NCT00131456|E1|Reported Event|Placebo|Matched Placebo
551860|NCT00131378|B5|Baseline|Total|Total of all reporting groups
551861|NCT00131378|B4|Baseline|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551862|NCT00131378|B3|Baseline|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551863|NCT00131378|B2|Baseline|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551864|NCT00131378|B1|Baseline|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551865|NCT00131378|P4|Participant Flow|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551866|NCT00131378|P3|Participant Flow|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551867|NCT00131378|P2|Participant Flow|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551868|NCT00131378|P1|Participant Flow|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551869|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551870|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551871|NCT00131378|O2|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551872|NCT00131378|O1|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551873|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551874|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551875|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551876|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551877|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551878|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551879|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551880|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551881|NCT00131378|O4|Outcome|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551882|NCT00131378|O3|Outcome|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551883|NCT00131378|O2|Outcome|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551884|NCT00131378|O1|Outcome|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551885|NCT00131378|E4|Reported Event|Male on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551886|NCT00131378|E3|Reported Event|Male on GH|"Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551887|NCT00131378|E2|Reported Event|Female on Placebo|"Participants received placebo.~Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months."
551888|NCT00131378|E1|Reported Event|Female on GH|"Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.~Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months."
551889|NCT00131352|B3|Baseline|Total|Total of all reporting groups
551890|NCT00131352|B2|Baseline|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551891|NCT00131352|B1|Baseline|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551892|NCT00131352|P2|Participant Flow|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the Initial Treatment Period.
551893|NCT00131352|P1|Participant Flow|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period. Participants from both treatment arms had the opportunity to receive an additional 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period.
551894|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551895|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551896|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551897|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551898|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551899|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551900|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551901|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551902|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551903|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551904|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551905|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551906|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551907|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551908|NCT00131352|O2|Outcome|Saline Control|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline.
551909|NCT00131352|O1|Outcome|Synvisc|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period.
551910|NCT00131352|E4|Reported Event|Synvisc (From Saline Control) - Repeat Treatment Period|Participants from the Saline Control Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
551945|NCT00130793|B1|Baseline|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551911|NCT00131352|E3|Reported Event|Synvisc - Repeat Treatment Period|Participants from the Synvisc Initial Treatment Period had the opportunity to receive 6 mL hylan G-F 20 (Synvisc) during the Repeat Treatment Period (weeks 26-30).
551912|NCT00131352|E2|Reported Event|Saline Control - Initial Treatment Period|Participants (control group) with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL phosphate buffered saline during the initial treatment period.
551913|NCT00131352|E1|Reported Event|Synvisc - Initial Treatment Period|Participants with symptomatic primary osteoarthritis (OA) of the knee received a single injection of 6 mL hylan G-F 20 (Synvisc) during the Initial Treatment Period (up to week 26).
551914|NCT00131248|B1|Baseline|All Study Participants|
551915|NCT00131248|P2|Participant Flow|Placebo, Medications, Placebo (Group 2)|"received 3-day course placebo, followed by 7-day course anti-reflux medication, followed by 4-day course placebo.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
551916|NCT00131248|P1|Participant Flow|Medications, Placebo, Medications (Group 1)|"3-day course of anti-reflux medications, followed by 7-day course placebo, followed by 4-day course anti-reflux medications.~All study medication administered via nipple or OG tube. Metaclopramide (anti-reflux) given in 0.1mg/kg/dose q6hrs, 30min. prior to feedings. Ranitidine, 3mg/kg/dose, q12hrs. Saline placebo at same respective volumes."
551917|NCT00131248|O2|Outcome|Placebo|
551918|NCT00131248|O1|Outcome|Medications|
551919|NCT00131248|E2|Reported Event|Placebo|
551920|NCT00131248|E1|Reported Event|Medications|
551921|NCT00130923|B3|Baseline|Total|Total of all reporting groups
551922|NCT00130923|B2|Baseline|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
551923|NCT00130923|B1|Baseline|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
551924|NCT00130923|P2|Participant Flow|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
551925|NCT00130923|P1|Participant Flow|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
551926|NCT00130923|O2|Outcome|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
551927|NCT00130923|O1|Outcome|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
551928|NCT00130923|E2|Reported Event|Oral Risperidone Aka Risperal|Oral Risperidone aka Risperdal. Participants who were randomized to take oral risperidone were titrated over two weeks up to a target dose of 4 mg per day. The maximum daily dose of oral risperidone was 6 mg.
551929|NCT00130923|E1|Reported Event|Risperidone Long Acting Injectable (LAI)|Risperidone Long Acting Injectable (LAI), begun with 25 mg dose given intramuscularly(IM)every two weeks. The dose was titrated up to a target dose of 37.5 mg IM, with injections given every two weeks. The maximum dose of LAI risperidone was 50 mg every two weeks.
551930|NCT00130832|B3|Baseline|Total|Total of all reporting groups
551931|NCT00130832|B2|Baseline|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551932|NCT00130832|B1|Baseline|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551933|NCT00130832|P2|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551934|NCT00130832|P1|Participant Flow|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551935|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551936|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551937|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551938|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551939|NCT00130832|O2|Outcome|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551940|NCT00130832|O1|Outcome|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551941|NCT00130832|E2|Reported Event|RotaTeq and Oral Poliovirus (OPV) Staggered|Subjects in Group 2, who received RotaTeq™ first followed by OPV between ≥14 to ≤28 days (2 to 4 weeks) later
551942|NCT00130832|E1|Reported Event|RotaTeq and Oral Poliovirus (OPV) Concomitantly|Subjects (Sbjs) in Group 1 who received 3 concomitant doses of RotaTeq™ and OPV ≥56 to ≤84 days (8 to 10 weeks) apart
551943|NCT00130793|B3|Baseline|Total|Total of all reporting groups
551944|NCT00130793|B2|Baseline|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
555699|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
551946|NCT00130793|P2|Participant Flow|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
551947|NCT00130793|P1|Participant Flow|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551948|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
551949|NCT00130793|O1|Outcome|ZOSTAVAX™With PGSU|ZOSTAVAX™with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551950|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
551951|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551952|NCT00130793|O2|Outcome|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
551953|NCT00130793|O1|Outcome|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551954|NCT00130793|E2|Reported Event|ZOSTAVAX™ With PGS|ZOSTAVAX™ with phosphate-gelatin-sucrose (PGS) stabilizer (~57,000 PFU), 1 subcutaneous 0.65-mL injection
551955|NCT00130793|E1|Reported Event|ZOSTAVAX™ With PGSU|ZOSTAVAX™ with phosphate-gelatin-sucrose-urea (PGSU) stabilizer (~45,000 plaque-forming units [PFU]), 1 subcutaneous 0.65-mL injection
551956|NCT00130780|B3|Baseline|Total|Total of all reporting groups
551957|NCT00130780|B2|Baseline|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
551958|NCT00130780|B1|Baseline|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
551959|NCT00130780|P2|Participant Flow|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
551960|NCT00130780|P1|Participant Flow|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
551961|NCT00130780|O2|Outcome|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
552003|NCT00130286|P1|Participant Flow|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
551962|NCT00130780|O1|Outcome|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
551963|NCT00130780|E2|Reported Event|B: Pre-Surgical Docetaxel, Cisplatin, and Adjuvant Bevacizumab|"Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab~Pre-Surgical Docetaxel and Cisplatin and Adjuvant Bevacizumab: Patients will receive preoperative 21-day cycles of cisplatin (75 mg/m2) and docetaxel (75 mg/m2) both given on Day 1 of each cycle.Patients will undergo repeat CT imaging after 2 cycles of therapy and patients with at least 10% reduction in bidimensional tumor volume will receive 2 additional neoadjuvant cycles of therapy (total 4 cycles of therapy).Surgery will occur at least 4 weeks after the last treatment with docetaxel and cisplatin.Adjuvant bevacizumab (15 mg/kg q21 days for 1 year, total 18 cycles) will be administered to all patients who undergo resection. Adjuvant bevacizumab will begin between days 42 and 56 after surgery.Patients may be referred for post-operative radiation therapy at the discretion of the treating physician. Every attempt will be made to administer the treatment on schedule. The treatment may be given +/- 3 days, and additionally"
551964|NCT00130780|E1|Reported Event|A: Pre-surgical Treatment With Bevacizumab Plus Chemotherapy|"Pre-surgical Treatment with Bevacizumab plus Chemotherapy~Pre-surgical Treatment with Bevacizumab + Chemotherapy: On Cycle 1 Day 1,patient will receive bevacizumab 15 mg/kg. On Cycle 1 Day 15, patients receive docetaxel (75 mg/m2), cisplatin (75 mg/m2). Cycle 2 begins 21 days after administration of docetaxel and cisplatin in Cycle 1. In Cycles 2 thru 3, patients will receive 2 preoperative 21-day cycles of docetaxel (75 mg/m2), cisplatin (75 mg/m2), and bevacizumab (15 mg/kg), all given on Day 1 of each cycle. The sequence of administration will be docetaxel, followed by cisplatin, followed by bevacizumab according to MSKCC Chemotherapy Guidelines. In Cycle 4 Day 1, patients will receive docetaxel (75 mg/m2) and cisplatin (75 mg/m2). Bevacizumab will not be given with Cycle 4. During Cycle 4, the only scheduled clinic visit will be on Day 1. Surgery will occur at least 42 days after the last treatment with bevacizumab. Every attempt will be made to administer the treatment on sc"
551965|NCT00130728|B3|Baseline|Total|Total of all reporting groups
551966|NCT00130728|B2|Baseline|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551967|NCT00130728|B1|Baseline|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551968|NCT00130728|P2|Participant Flow|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551969|NCT00130728|P1|Participant Flow|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551970|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551971|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551972|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551973|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551974|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551975|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551976|NCT00130728|O2|Outcome|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551977|NCT00130728|O1|Outcome|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551978|NCT00130728|E2|Reported Event|Erlotinib HCl + Placebo|oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
551979|NCT00130728|E1|Reported Event|Erlotinib HCl + Bevacizumab|oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
551980|NCT00130689|B1|Baseline|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
551981|NCT00130689|P1|Participant Flow|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
551982|NCT00130689|O1|Outcome|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
551983|NCT00130689|E1|Reported Event|Cetuximab|Patients received cetuximab at an initial dose of 400 mg/m2 administered IV over 120 min, followed by weekly infusions at 250 mg/m2 administered IV over 60 min. Once cycle was 4 weeks of therapy. Patients received treatment until disease progression or unacceptable toxicity.
559149|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
551984|NCT00130637|B1|Baseline|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
551985|NCT00130637|P1|Participant Flow|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
551986|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
551987|NCT00130637|O1|Outcome|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
551988|NCT00130637|E1|Reported Event|Daclizumab|An induction regimen of intravenous (IV) daclizumab at 8 mg/kg was given on Day 0 followed by another IV dose of 4 mg/kg at Day 14, provided the safety endpoint was not met. Participants who showed a two-step reduction in their ocular inflammation or a decrease to inactivity, without serious adverse events, had the option to receive extended treatments of 2 mg/kg IV daclizumab treatments at 4-week intervals, beginning day 28, for up to a total of 52 weeks.
551989|NCT00130520|B1|Baseline|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551990|NCT00130520|P1|Participant Flow|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551991|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551992|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551993|NCT00130520|O1|Outcome|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551994|NCT00130520|E1|Reported Event|Bevacizumab and Erlotinib|This is an open label study. All subjects received erlotinib 150 mg/day orally and bevacizumab 10 mg/kg intravenously every 2 weeks until disease progression. Progression free survival (PFS) was defined as the time from the start of therapy to the time of the first documentation of progression, symptomatic deterioration, or death due to any cause
551995|NCT00130286|B5|Baseline|Total|Total of all reporting groups
551996|NCT00130286|B4|Baseline|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
551997|NCT00130286|B3|Baseline|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
551998|NCT00130286|B2|Baseline|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
551999|NCT00130286|B1|Baseline|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552000|NCT00130286|P4|Participant Flow|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552001|NCT00130286|P3|Participant Flow|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552002|NCT00130286|P2|Participant Flow|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552031|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552004|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552005|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552006|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552007|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552008|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552009|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552010|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552011|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552012|NCT00130286|O4|Outcome|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552013|NCT00130286|O3|Outcome|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552014|NCT00130286|O2|Outcome|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552015|NCT00130286|O1|Outcome|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552016|NCT00130286|E4|Reported Event|Double Placebo|"Placebo for recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552017|NCT00130286|E3|Reported Event|rhGH + Rosi Placebo|"Recombinant human growth hormone + placebo for rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552018|NCT00130286|E2|Reported Event|rhGH Placebo + Rosi|"Placebo for recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552019|NCT00130286|E1|Reported Event|rhGH + Rosi|"Recombinant human growth hormone + rosiglitazone~Rosiglitazone: 4 mg tablet twice a day x 12 weeks (double-blind phase)~Recombinant human growth hormone + rosiglitazone: Recombinant human growth hormone or placebo 3 mg s.c. x 12 weeks (double-blind phase)"
552020|NCT00130247|B3|Baseline|Total|Total of all reporting groups
552021|NCT00130247|B2|Baseline|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552022|NCT00130247|B1|Baseline|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552023|NCT00130247|P2|Participant Flow|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552024|NCT00130247|P1|Participant Flow|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552025|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552026|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552027|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552028|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552029|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552030|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552032|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552033|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552034|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552035|NCT00130247|O2|Outcome|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552036|NCT00130247|O1|Outcome|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552037|NCT00130247|E2|Reported Event|6-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 4 months of daily INH plus rifampicin over a maximum time period of 28 weeks.
552038|NCT00130247|E1|Reported Event|4-Month Arm|Daily treatment with INH, rifampicin, ethambutol and pyrazinamide for 2 months followed by 2 months of daily INH plus rifampicin over a maximum time period of 18 weeks.
552039|NCT00130039|B3|Baseline|Total|Total of all reporting groups
552040|NCT00130039|B2|Baseline|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552041|NCT00130039|B1|Baseline|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552042|NCT00130039|P2|Participant Flow|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552043|NCT00130039|P1|Participant Flow|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552044|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552045|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552046|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552047|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552048|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552049|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552050|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552051|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552052|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552053|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552054|NCT00130039|O2|Outcome|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552055|NCT00130039|O1|Outcome|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552056|NCT00130039|E2|Reported Event|Clopidogrel|clopidogrel 75mg per day and matching placebo of cilostazol
552057|NCT00130039|E1|Reported Event|Cilostazol|cilostazol 100mg twice a day plus placebo of clopidogrel
552058|NCT00129961|B3|Baseline|Total|Total of all reporting groups
552059|NCT00129961|B2|Baseline|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552060|NCT00129961|B1|Baseline|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552061|NCT00129961|P2|Participant Flow|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552115|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552116|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552117|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552118|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552119|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552062|NCT00129961|P1|Participant Flow|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552063|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552064|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552065|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552066|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552067|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552068|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552120|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552121|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552122|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552123|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552069|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552070|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552071|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552072|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552073|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552074|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552075|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552124|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552125|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552126|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552127|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
559150|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
552076|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552077|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552078|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552079|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552080|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552081|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552082|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552128|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552129|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552130|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552131|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552083|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552084|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552085|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552086|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552087|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552088|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552089|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552132|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552133|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552134|NCT00129766|E2|Reported Event|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552135|NCT00129766|E1|Reported Event|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
559151|NCT00110305|O5|Outcome|Efavirenz|Efaviren 600 mg once daily
552090|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552091|NCT00129961|O2|Outcome|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552092|NCT00129961|O1|Outcome|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552093|NCT00129961|E2|Reported Event|Calcineurin Inhibitor (CNI) Based Regimen|Baseline CNI therapy was continued after randomization and doses could be adjusted throughout the study as indicated, but therapy could not be withdrawn. Cyclosporine could be switched to tacrolimus, and vice versa. If warranted subjects could be switched between MMF, MPS, or AZA or their doses could be decreased, temporarily withheld, or discontinued. Subjects undergoing discontinuation of MMF, MPS, or AZA had to receive CS ≥2.5 mg/day of prednisone or the equivalent thereof. If subjects were not receiving MMF, MPS, or AZA at the time of randomization, the addition of MMF, MPS, or AZA was permitted if clinically indicated. If subjects were receiving CS at the time of randomization, CS was maintained at ≥2.5 mg/day of prednisone or the equivalent thereof. CS withdrawal was prohibited. If subjects were not receiving CS at the time of randomization, treatment could be initiated during the conduct of the study if clinically indicated.
552094|NCT00129961|E1|Reported Event|Sirolimus (SRL) Based Regimen|All subjects discontinued Calcineurin inhibitors (CNI) after the morning dose on day 1. SRL was initiated with a loading dose of 6-12mg on day 1, followed by 2-4mg daily and was adjusted to maintain a whole blood trough concentration of 5-15ng/mL (high performance liquid chromatography [HPLC]). Once the SRL trough concentration was ≥ 5ng/mL, subjects receiving mycophenolate mofetil (MMF), mycophenolate sodium (MPS), or azathioprine (AZA) at randomization had doses reduced to ≤1.5 g/day, ≤1080 mg/day or ≤75 mg/day respectively. If warranted subjects could be switched between MMF, MPS, or AZA or their doses decreased, temporarily withheld, or discontinued. Subjects receiving corticosteroids (CS) at time of randomization or if MMF, MPS, or AZA was discontinued, had to receive CS ≥2.5mg/day of prednisone. Subjects not receiving MMF, MPS, or AZA at time of randomization remained on a minimum of double therapy (SRL and CS). Addition of MMF, MPS, or AZA was permitted.
552095|NCT00129766|B3|Baseline|Total|Total of all reporting groups
552096|NCT00129766|B2|Baseline|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552097|NCT00129766|B1|Baseline|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552098|NCT00129766|P2|Participant Flow|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552099|NCT00129766|P1|Participant Flow|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552100|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552101|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552102|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552103|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552104|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552105|NCT00129766|O1|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552106|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552107|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552108|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552109|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552110|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552111|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552112|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552113|NCT00129766|O1|Outcome|Palivizumab|Palivizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552114|NCT00129766|O2|Outcome|Motavizumab|Motavizumab, 15 mg/kg administered intramuscularly for 5 monthly doses
552136|NCT00129727|B1|Baseline|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552137|NCT00129727|P1|Participant Flow|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552138|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552139|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552140|NCT00129727|O1|Outcome|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552141|NCT00129727|E1|Reported Event|Phase II of Carboplatin, Pacitaxel, and Bevacizumab|Phase II Evaluation of Carboplatin, Pacitaxel, and Bevacizumab as First Line Chemotherapy and Consolidation for Advanced Ovarian Cancer.
552142|NCT00129623|B3|Baseline|Total|Total of all reporting groups
552143|NCT00129623|B2|Baseline|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552144|NCT00129623|B1|Baseline|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552145|NCT00129623|P2|Participant Flow|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552146|NCT00129623|P1|Participant Flow|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552147|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552148|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552149|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552150|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552151|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia who were administered 150 mg IBN tablet orally (PO) once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
552152|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia who were administered matching placebo tablet PO once monthly. All participants received 500 mg/d calcium and 400 international units [IU]/d vitamin D as dietary supplements consisting of one tablet a day of OSCAL for the duration of the study. Participants received 12 months of treatment and were followed for an additional period of 15 days.
552153|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552154|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552155|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552183|NCT00129480|B2|Baseline|Treatment as Usual|Treatment as usual which includes standard pain care, clinician generated referrals for additional consultation and ancillary services
552156|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552157|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552158|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552159|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552160|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552161|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552162|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552163|NCT00129623|O2|Outcome|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552164|NCT00129623|O1|Outcome|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552165|NCT00129623|E2|Reported Event|Ibandronate (IBN) 150 mg Monthly|Participants with postmenopausal osteopenia were administered 150 mg Ibandronate (IBN) tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg/d calcium and 400 international units [IU]/d vitamin D) once a day as dietary supplements, for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552166|NCT00129623|E1|Reported Event|Placebo|Participants with postmenopausal osteopenia were administered matching placebo tablet orally once monthly. All participants received OSCAL tablet (containing 500 mg calcium and 400 international units [IU] vitamin D) once a day as dietary supplements for the duration of the study. Participants received a total of 12 months of treatment and were followed for an additional period of 15 days.
552167|NCT00129545|B4|Baseline|Total|Total of all reporting groups
552168|NCT00129545|B3|Baseline|Roll-in|Subjects received WATCHMAN Left Atrial Appendage Closure Technology but were not included in the outcome analysis
552169|NCT00129545|B2|Baseline|Warfarin Control|Subjects were treated with current standard of care Oral Anticoagulation Therapy with Warfarin
552170|NCT00129545|B1|Baseline|WATCHMAN|WATCHMAN Left Atrial Appendage Closure Technology:
552171|NCT00129545|P3|Participant Flow|WARFARIN|Randomized to receive Warfarin control
552172|NCT00129545|P2|Participant Flow|WATCHMAN|Randomized to receive implantation of the WATCHMAN left atrial appendage (LAA) closure Technology
552173|NCT00129545|P1|Participant Flow|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
552174|NCT00129545|O1|Outcome|WATCHMAN|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~Implant of WATCHMAN Left Atrial Appendage Closure Technology"
552175|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
552176|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
552177|NCT00129545|O2|Outcome|Warfarin Control|"Subjects are treated with current standard of care Oral Anticoagulation Therapy with Warfarin~Warfarin: Subjects receive warfarin"
552178|NCT00129545|O1|Outcome|Implantable Device|"Implantable WATCHMAN Left ATrial Appendage Occlusion Device~WATCHMAN Left Atrial Appendage Closure Technology: Implant of WATCHMAN Left Atrial Appendage Closure Technology"
552179|NCT00129545|E3|Reported Event|WARFARIN|Randomized to receive Warfarin control
552180|NCT00129545|E2|Reported Event|WATCHMAN|Randomized to receive implantation of the WATCHMAN LAA closure Device
552181|NCT00129545|E1|Reported Event|Roll-in|Investigational centers were allowed up to 3 roll in subjects before initiating the randomization phase
552182|NCT00129480|B3|Baseline|Total|Total of all reporting groups
552288|NCT00129220|B3|Baseline|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552184|NCT00129480|B1|Baseline|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
552185|NCT00129480|P2|Participant Flow|Treatment as Usual|Treatment as usual
552186|NCT00129480|P1|Participant Flow|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
552187|NCT00129480|O2|Outcome|Treatment as Usual|Pain treatment as usual
552188|NCT00129480|O1|Outcome|Assistance With Pain Treatment (Intervention)|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
552189|NCT00129480|E2|Reported Event|Treatment as Usual|Treatment as usual, which includes standard pain care, clinician-generated referrals for additional consultation and ancillary services
552190|NCT00129480|E1|Reported Event|Assistance With Pain Treatment|"Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers~Assistance with Pain treatment: Care management intervention including assessment, decision support, patient activation, education and followup, provider education, feedback to providers. Intervention delivered for 12 months."
552191|NCT00129467|B3|Baseline|Total|Total of all reporting groups
552192|NCT00129467|B2|Baseline|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
552193|NCT00129467|B1|Baseline|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
552194|NCT00129467|P2|Participant Flow|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
552195|NCT00129467|P1|Participant Flow|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
552196|NCT00129467|O2|Outcome|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
552197|NCT00129467|O1|Outcome|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
552198|NCT00129467|E2|Reported Event|Placebo + SSRI|During the 18-day blind treatment period, subjects will be prescribed placebo 1-2 capsules twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram.
552199|NCT00129467|E1|Reported Event|Methylphenidate + SSRI|During the 18-day blind treatment period, subjects will be prescribed Methylphenidate 5-10 mg twice per day and Selective Serotonin Reuptake Inhibitor. Subjects receiving a SSRI when they begin the study, will continue on the recommended dose of that SSRI; subjects not already receiving a SSRI will be prescribed 10-20 mg per day Citalopram. Subjects who respond to methylphenidate treatment will have the option of continuing on methylphenidate, up to 15 mg bid, and an antidepressant in the 6 week open label portion of the study.
552200|NCT00129441|B3|Baseline|Total|Total of all reporting groups
552201|NCT00129441|B2|Baseline|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552202|NCT00129441|B1|Baseline|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552203|NCT00129441|P2|Participant Flow|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552204|NCT00129441|P1|Participant Flow|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552205|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552206|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552207|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552208|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552209|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552210|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552211|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552212|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552213|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552214|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552215|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552216|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552217|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552218|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552219|NCT00129441|O2|Outcome|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552220|NCT00129441|O1|Outcome|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552221|NCT00129441|E2|Reported Event|Placebo|Medications were dispensed weekly in blister packs by the hospital pharmacy, using the same number of pills as those on active drug.
552222|NCT00129441|E1|Reported Event|L-830982|The initial dose of L-830982 was 3.0 mg twice daily (b.i.d.) the dosage increased to 5.0 mg b.i.d. at the end of week 1 and 8.0 mg b.i.d. at the end of week 2, which was continued for the remaining 2 weeks of the trial. Medications were dispensed weekly in blister packs by the hospital pharmacy.
552223|NCT00129402|B3|Baseline|Total|Total of all reporting groups
552224|NCT00129402|B2|Baseline|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552225|NCT00129402|B1|Baseline|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552226|NCT00129402|P7|Participant Flow|Long-term Experience Ezetimbe/Simvastatin|Subjects who received long-term coadministration of ezetimibe with simvastatin once daily
552227|NCT00129402|P6|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 40|Subjects who received simvastatin monotherapy 40 mg once daily
552228|NCT00129402|P5|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 20|Subjects who received simvastatin monotherapy 20 mg once daily
552229|NCT00129402|P4|Participant Flow|Ezetimibe Matching Placebo/ Simvastatin 10|Subjects who received simvastatin monotherapy 10 mg once daily
552230|NCT00129402|P3|Participant Flow|Ezetimibe/Simvastatin 10/40|Subjects who received ezetimibe 10 mg plus simvastatin 40 mg once daily
552231|NCT00129402|P2|Participant Flow|Ezetimibe/Simvastatin 10/20|Subjects who received ezetimibe 10 mg with simvastatin 10 mg once daily
552232|NCT00129402|P1|Participant Flow|Ezetimibe/Simvastatin 10/10|Subjects who received ezetimibe 10 mg plus simvastatin 10 mg once daily
552233|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552234|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552235|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552236|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552237|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552238|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552289|NCT00129220|B2|Baseline|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552239|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552240|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552241|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|pooled subjects who received simvastatin 10 mg monotherapy, simvastatin 20 mg monotherapy, or simvastatin 40 mg monotherapy
552242|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552243|NCT00129402|O2|Outcome|Pooled Subjects Who Received Simvastatin Monotherapy|Pooled subjects who received ezetimibe placebo plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552244|NCT00129402|O1|Outcome|Pooled Subjects Who Received Ezetimibe With Simvastatin|Pooled subjects who received ezetimibe 10 mg plus simvastatin 10 mg, simvastatin 20 mg, or simvastatin 40 mg
552245|NCT00129402|E3|Reported Event|Long-term Coadministration of Ezetimibe With Simvastatin|"Column 3 provides the combined AE data collected for~all subjects that participated during Period 3. One subject who entered Period 3 did not receive study medication and was not included in the analysis."
552246|NCT00129402|E2|Reported Event|Simvastatin Monotherapy|"Column 2 provides the combined AE data collected for subjects in the simvastatin monotherapy treatment~groups during Period 1 and Period 2."
552247|NCT00129402|E1|Reported Event|Ezetimibe With Simvastatin|Column 1 provides the combined AE data collected for subjects in the ezetimibe with simvastatin treatment groups during Period 1 and Period 2
552248|NCT00129311|B3|Baseline|Total|Total of all reporting groups
552249|NCT00129311|B2|Baseline|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552250|NCT00129311|B1|Baseline|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552251|NCT00129311|P2|Participant Flow|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552252|NCT00129311|P1|Participant Flow|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552253|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552254|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552255|NCT00129311|O2|Outcome|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552256|NCT00129311|O1|Outcome|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552257|NCT00129311|E2|Reported Event|Placebo|"Placebo~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552258|NCT00129311|E1|Reported Event|Selegiline|"Selegiline~Selegiline: 5 mg capsules taken by mouth. Participants take 5 mg once a day for the first week of the study, then increase the dose to 5 mg twice a day for 6 weeks, then take 5 mg once a day during the last week of the study. Participants receiving the placebo pill take 1 pill per day for the first week of the study and 1 pill twice a day for the other weeks."
552259|NCT00129259|B3|Baseline|Total|Total of all reporting groups
552260|NCT00129259|B2|Baseline|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552261|NCT00129259|B1|Baseline|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552262|NCT00129259|P2|Participant Flow|Diabetes Standard of Care Treatment|"Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
552263|NCT00129259|P1|Participant Flow|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|"Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.~Iron supplementation was initiated status post treatment randomization."
552264|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552265|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552266|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552267|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552268|NCT00129259|O2|Outcome|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552269|NCT00129259|O1|Outcome|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552270|NCT00129259|E2|Reported Event|Diabetes Standard of Care Treatment|Subjects received intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552271|NCT00129259|E1|Reported Event|Anti-CD3 mAb Plus Diabetes Standard of Care Treatment|Other name: mAb hOKT3gamma1(Ala-Ala), Teplizumab, MGA031. Subjects received 1.) a 14-day course of anti-CD3 monoclonal antibody (mAb) intravenously (IV) comprised of daily doses of 51 µg/m2, 103 µg/m2, 207 µg/m2, 413 µg/m2, and 10 days of 826 µg/m2 [Cycle 1] and, when eligible per protocol, receipt of a second 14-day course after a 12-month interval (at month 13)[Cycle 2]. Note: Prior to May 2007, the course of IV daily doses of anti-CD3 mAb were: 57 µg/m2, 115 µg/m2, 230 µg/m2, 460 µg/m2, and 10 days of 919 µg/m2 and, when eligible per protocol, a second course after a 12-month interval (at month 13). 2.) and intensive diabetes standard of care treatment/management under the care of a physician: dietary counseling, insulin dosing and multiple consultations during the course of the trial with the clinical diabetes management team.
552272|NCT00129246|B3|Baseline|Total|Total of all reporting groups
552273|NCT00129246|B2|Baseline|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552274|NCT00129246|B1|Baseline|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552275|NCT00129246|P2|Participant Flow|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552276|NCT00129246|P1|Participant Flow|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552277|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552278|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552279|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552280|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552281|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552282|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552283|NCT00129246|O2|Outcome|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552284|NCT00129246|O1|Outcome|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552285|NCT00129246|E2|Reported Event|Naltrexone +Bupropion|"The active comparator in this 7-week open label study investigation was naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day) compared to matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen (bupropion only).~Naltrexone : Participants received naltrexone hydrochloride on the sixth day of bupropion treatment, and the initial dose was 12.5 mg, followed by 25 mg daily for the duration of the 7-week treatment.~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552286|NCT00129246|E1|Reported Event|Bupropion Only|"The placebo comparator was a group of matched controls who received an identical psychosocial intervention and bupropion SR treatment regimen in a similar 7-week study investigation compared to naltrexone hydrochloride (25 mg/day) in combination with bupropion hydrochloride SR (300 mg/day).~Bupropion : Starting with the baseline visit, all participants received 150 mg of bupropion SR once per day for 3 days, then twice per day for the duration of the 7-week treatment period."
552287|NCT00129220|B4|Baseline|Total|Total of all reporting groups
552291|NCT00129220|P3|Participant Flow|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552292|NCT00129220|P2|Participant Flow|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552293|NCT00129220|P1|Participant Flow|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552294|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552295|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552296|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552297|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552298|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552299|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552300|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552301|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552302|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552303|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552304|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552305|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552306|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552307|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552308|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552309|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552310|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552311|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552312|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552313|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552314|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552315|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552316|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552317|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552318|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day
552319|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day
552320|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552321|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552322|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552323|NCT00129220|O3|Outcome|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552324|NCT00129220|O2|Outcome|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552325|NCT00129220|O1|Outcome|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552326|NCT00129220|E3|Reported Event|Placebo|placebo for 3 weeks, then olanzapine 5 to 20 mg per day for 3 weeks
552327|NCT00129220|E2|Reported Event|Haloperidol|haloperidol: 2.5 to 10 mg per day for 6 weeks
552328|NCT00129220|E1|Reported Event|Olanzapine|olanzapine: 5 to 20 mg per day for 6 weeks
552329|NCT00129129|B4|Baseline|Total|Total of all reporting groups
552330|NCT00129129|B3|Baseline|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552331|NCT00129129|B2|Baseline|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552332|NCT00129129|B1|Baseline|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh..
552333|NCT00129129|P5|Participant Flow|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552334|NCT00129129|P4|Participant Flow|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
552852|NCT00128713|P1|Participant Flow|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
555700|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
552335|NCT00129129|P3|Participant Flow|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552336|NCT00129129|P2|Participant Flow|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552337|NCT00129129|P1|Participant Flow|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552338|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552339|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552340|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552341|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552342|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552343|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552344|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552345|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552357|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552853|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552346|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552347|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552348|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552349|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552350|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552351|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552352|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552353|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552354|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552355|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552356|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552854|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552855|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
559155|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
552358|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552359|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552360|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552361|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552362|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
552363|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552364|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552365|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552366|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552367|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552368|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552369|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552370|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552371|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552372|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552373|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552374|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552375|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552376|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552377|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552378|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552379|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552380|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552856|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552857|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
559156|NCT00110305|E2|Reported Event|Efavirenz|Efavirenz 600 mg once daily
552381|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552382|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552383|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552384|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552385|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552386|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552387|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552388|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552389|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552390|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552391|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552858|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552859|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
561170|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
552392|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552393|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552394|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552395|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552396|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552397|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552398|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552399|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552400|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552401|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552402|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552426|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552860|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552861|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552403|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552404|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552405|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552406|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552407|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552408|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552409|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
552410|NCT00129129|O3|Outcome|ActHIB/Menhibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552411|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552412|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552413|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
552414|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552862|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552415|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552416|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552417|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552418|NCT00129129|O1|Outcome|Menhibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552419|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552420|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552421|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552422|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552423|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552424|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552425|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552448|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
561179|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
552427|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552428|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552429|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552430|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552431|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects primed with ActHIB vaccine who received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the fourth dose phase, Menhibrix and Prevnar vaccines were administered intramuscularly in the right and left upper thigh, respectively.
552432|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552433|NCT00129129|O1|Outcome|Menhibrix Group|Subjects of 6-12 weeks of age received 3 doses of Menhibrix vaccine co-administered with Pediarix and Prevnar vaccines during the primary vaccination phase. Subjects received a fourth dose of Menhibrix vaccine and a concomitant fourth dose of Prevnar vaccine during the fourth dose vaccination phase. In the primary phase, Menhibrix vaccine was administered intramuscularly into the right upper thigh. Pediarix and Prevnar vaccines were administered intramuscularly into the left upper thigh and the left lower thigh, respectively. In the fourth dose phase, Menhibrix vaccine was administered by the same route at the same vaccination site and Prevnar was administered intramuscularly in the left upper thigh.
552434|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552435|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552436|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552437|NCT00129129|O3|Outcome|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552438|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552863|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552439|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552440|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552441|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552442|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552443|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552444|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552445|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552446|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552447|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552449|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552450|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552451|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552452|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552453|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552454|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552455|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552456|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552457|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552550|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552458|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552459|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552460|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552461|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552462|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552463|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552464|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552465|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552466|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
553588|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
552467|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552468|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552469|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552470|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552471|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552472|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552473|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552474|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552475|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552476|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552477|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552478|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552479|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552480|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552481|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552482|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552483|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552484|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
553589|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
552485|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552486|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552487|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552488|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552489|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552490|NCT00129129|O2|Outcome|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552491|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552492|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552493|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552864|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
563379|NCT00098059|O4|Outcome|13 to <= 18 Years|
552494|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552495|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552496|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552497|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552498|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552499|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552500|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552501|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552502|NCT00129129|O1|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552503|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552504|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552865|NCT00128713|O3|Outcome|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552866|NCT00128713|O2|Outcome|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552867|NCT00128713|O1|Outcome|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552505|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552506|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552507|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552508|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552509|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552510|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552511|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552512|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552513|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552514|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552515|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552868|NCT00128713|E3|Reported Event|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552869|NCT00128713|E2|Reported Event|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552516|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552517|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552518|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552519|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552520|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552521|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552522|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552523|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552524|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552525|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552551|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552870|NCT00128713|E1|Reported Event|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552871|NCT00128661|B3|Baseline|Total|Total of all reporting groups
552526|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552527|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552528|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552529|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552530|NCT00129129|O3|Outcome|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552531|NCT00129129|O2|Outcome|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552532|NCT00129129|O1|Outcome|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552533|NCT00129129|E5|Reported Event|ActHIB/ActHIB Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase of the study (study 101858) and received at Month 10-13 a fourth dose of ActHIB™ and a concomitant fourth dose of Prevnar™. ActHIB™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552534|NCT00129129|E4|Reported Event|ActHIB/MenHibrix Group|Subjects in the Group were followed solely during the period of the Fourth-Dose Phase of the study (Study 102015), from Month 10-13 to Month 11-14. Subjects in this Group had been primed with ActHIB™ during Primary Phase (study 101858) and received at Month 10-13 a fourth dose of MenHibrix™ and a concomitant fourth dose of Prevnar™. MenHibrix™ and Prevnar™ were administered intramuscularly in the right and left upper thighs, respectively.
552535|NCT00129129|E3|Reported Event|Menomune Group|Subjects in the Group were followed solely during the period of Primary Phase (Study 101858), up to Month 10. Subjects in the Group, aged 3-5 years at enrolment, received one dose of Menomune™ at Day 0. Menomune™ was administered subcutaneously in the left deltoid region.
552536|NCT00129129|E2|Reported Event|ActHIB Group|During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of ActHIB™ vaccine co-administered with the Pediarix™ and Prevnar™ vaccines (at Day 0 and Months 2 and 4). Subjects in this Group were followed from Day 0 up to Month 10-13 solely. During Fourth-Dose Phase (Study 102015), these subjects were followed as subjects either in the ActHIB/MenHibrix Group or in the ActHIB/ActHIB Group, receiving then one dose of either MenHibrix™ or ActHIB™ concomitantly with one dose of Prevnar™. During Primary Phase, ActHIB™ was administered intramuscularly (IM) in the right upper thigh, and the Pediarix™ and Prevnar™ vaccines IM in the left upper and lower thighs, respectively.
552552|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552537|NCT00129129|E1|Reported Event|MenHibrix Group|Subjects in the Group were followed during the entire study period, from Day 0 up to study end 6 months post fourth dose vaccination. During Primary Phase (Study 101858), subjects in this group, aged 6-12 weeks at enrolment, received 3 doses of MenHibrix™ co-administered with Pediarix™ and Prevnar™ (at Day 0 and Months 2 and 4). During Fourth-Dose Phase (Study 102015), subjects primed with 3 doses of MenHibrix™ during the Primary Phase received one dose of MenHibrix™ and one concomitant dose of Prevnar™ at Month 10-13. During Primary Phase, MenHibrix™ was administered intramuscularly (IM) in the right upper thigh, and Pediarix™ and Prevnar™ IM in the left upper and lower thighs, respectively. During Fourth-Dose Phase, MenHibrix™ was administered by the same route and at the same site as during Primary Phase, and Prevnar™ was administered IM in the left upper thigh.
552538|NCT00129116|B6|Baseline|Total|Total of all reporting groups
552539|NCT00129116|B5|Baseline|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552540|NCT00129116|B4|Baseline|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552541|NCT00129116|B3|Baseline|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552542|NCT00129116|B2|Baseline|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552543|NCT00129116|B1|Baseline|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552544|NCT00129116|P5|Participant Flow|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552545|NCT00129116|P4|Participant Flow|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552546|NCT00129116|P3|Participant Flow|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552547|NCT00129116|P2|Participant Flow|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552548|NCT00129116|P1|Participant Flow|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552549|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552830|NCT00128921|E1|Reported Event|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
552831|NCT00128830|B1|Baseline|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563380|NCT00098059|O3|Outcome|6 to <=12 Years|
552553|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552554|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552555|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552556|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552557|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552558|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552559|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552560|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552561|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552562|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552563|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552564|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552565|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552832|NCT00128830|P1|Participant Flow|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563381|NCT00098059|O2|Outcome|2 to <6 Years|
552566|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552567|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552568|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552569|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552570|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552571|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552572|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552573|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552574|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552575|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552576|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552577|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552578|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552833|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
552579|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552580|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552581|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552582|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552583|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552584|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552585|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552586|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552587|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552588|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552589|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552590|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552591|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552834|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563382|NCT00098059|O1|Outcome|1 to < 2 Years|
552592|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552593|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552594|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552595|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552596|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552597|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552598|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552599|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552600|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552601|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552602|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552603|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552604|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552835|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563383|NCT00098059|O4|Outcome|13 to <=18 Years|
552605|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552606|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552607|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552608|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552609|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552610|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552611|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552612|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552613|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552614|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552615|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552616|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552617|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552836|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563384|NCT00098059|O3|Outcome|6 to <13 Years|
552618|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552619|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552620|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552621|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552622|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552623|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552624|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552625|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552626|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552627|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552628|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552629|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552630|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552837|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563385|NCT00098059|O2|Outcome|2 to <6 Years|
552631|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552632|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552633|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552634|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552635|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552636|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552637|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552638|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552639|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552640|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552641|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552642|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552643|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552838|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
552644|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552645|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552646|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552647|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552648|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552649|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552650|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552651|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552652|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552653|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552654|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552655|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552656|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552839|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563386|NCT00098059|O1|Outcome|1 to < 2 Years|
552657|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552658|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552659|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552660|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552661|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552662|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552663|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552664|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552665|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552666|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552667|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552668|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552669|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552840|NCT00128830|O1|Outcome|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
563387|NCT00098059|O4|Outcome|13 to <=18 Years|
552670|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552671|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552672|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552673|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552674|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552675|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552676|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552677|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552678|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552679|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552680|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552681|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552682|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552841|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
555701|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
552683|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552684|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552685|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552686|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552687|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552688|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552689|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552690|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552691|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552692|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552693|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552694|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552695|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552842|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
555702|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
552696|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552697|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552698|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552699|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552700|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552701|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552702|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552703|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552704|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552705|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552706|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552707|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552708|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552843|NCT00128830|O2|Outcome|Viral Load Less Than 50 Copies/mL|Viral load less than 50 copies/mL at TMC125-C229 Baseline
563388|NCT00098059|O3|Outcome|6 to <13 Years|
552709|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552710|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552711|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552712|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552713|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552714|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552715|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552716|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552717|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552718|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552719|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552720|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552721|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552844|NCT00128830|O1|Outcome|Viral Load More Than or Equal to 50 Copies/mL|Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
555703|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
552722|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552723|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552724|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552725|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552726|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552727|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552728|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552729|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552730|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552731|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552732|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552733|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552734|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552845|NCT00128830|E1|Reported Event|Etravirine|800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
552846|NCT00128713|B4|Baseline|Total|Total of all reporting groups
552735|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552736|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552737|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552738|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552739|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552740|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552741|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552742|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552743|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552744|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552745|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552746|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552747|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552847|NCT00128713|B3|Baseline|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
563389|NCT00098059|O2|Outcome|2 to <6 Years|
552748|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552749|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552750|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552751|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552752|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552753|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552754|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552755|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552756|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552757|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552758|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552759|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552760|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552848|NCT00128713|B2|Baseline|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
563390|NCT00098059|O1|Outcome|1 to < 2 Years|
552761|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552762|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552763|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552764|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552765|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552766|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552767|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552768|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552769|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552770|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552771|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552772|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552773|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552849|NCT00128713|B1|Baseline|Lower Dose Platelets|Lower Dose Prophylactic Platelets (1.1 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
552774|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552775|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552776|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552777|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552778|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552779|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552780|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552781|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552782|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552783|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552784|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552785|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552786|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552850|NCT00128713|P3|Participant Flow|Higher Dose Platelets|Higher Dose Prophylactic Platelets (4.4 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
563391|NCT00098059|O4|Outcome|13 to <=18 Years|
552787|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552788|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552789|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552790|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552791|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552792|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552793|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552794|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552795|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552796|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552797|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552798|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552799|NCT00129116|O5|Outcome|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552851|NCT00128713|P2|Participant Flow|Medium Dose Platelets|Medium Dose Prophylactic Platelets (2.2 x 10^11 per m^2 Body Surface Area per transfusion, +/- 25%)
563392|NCT00098059|O3|Outcome|6 to <13 Years|
552800|NCT00129116|O4|Outcome|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552801|NCT00129116|O3|Outcome|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552802|NCT00129116|O2|Outcome|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552803|NCT00129116|O1|Outcome|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552804|NCT00129116|E5|Reported Event|Menjugate/Infanrix-hexa Group|Subjects received Menjugate vaccine and Infanrix-hexa vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menjugate and Infanrix-hexa vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552805|NCT00129116|E4|Reported Event|Menitorix/Infanrix-penta Group|Subjects received Menitorix vaccine and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menitorix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552806|NCT00129116|E3|Reported Event|Menhibrix F3/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 3 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552807|NCT00129116|E2|Reported Event|Menhibrix F2/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 2 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552808|NCT00129116|E1|Reported Event|Menhibrix F1/Infanrix-penta Group|Subjects received Menhibrix vaccine formulation 1 and Infanrix-penta vaccine. Vaccines were administered as a 3-dose primary vaccination course at 2, 3 and 4 months of age (at study Months 0, 1 and 2 of the primary phase). At 12-18 months of age (at study Month 0 of the booster phase), subjects received a booster dose of the two vaccines administered in the primary vaccination course. Menhibrix and Infanrix-penta vaccines were administered intramuscularly in the left and right anterolateral thigh, respectively.
552809|NCT00128921|B4|Baseline|Total|Total of all reporting groups
552810|NCT00128921|B3|Baseline|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
552811|NCT00128921|B2|Baseline|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
552812|NCT00128921|B1|Baseline|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
552813|NCT00128921|P3|Participant Flow|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
552814|NCT00128921|P2|Participant Flow|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
552815|NCT00128921|P1|Participant Flow|Bortezomib, Cohort a|treatment: 1.3 mg/m^2
552816|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
552817|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
552818|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
552819|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
552820|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
552821|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
552822|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11).
552823|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
552824|NCT00128921|O2|Outcome|Cohort B|Cohort B: Received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11.
552825|NCT00128921|O1|Outcome|Cohort A|Cohort A: Received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11.
552826|NCT00128921|O2|Outcome|Cohort B|Cohort B: Parathyroid hormone (participants received bortezomib 1.0 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
552827|NCT00128921|O1|Outcome|Cohort A|Cohort A: Parathyroid hormone (participants received bortezomib 1.3 mg/m2 per days 1, 4, 8 and 11 for three 21-day cycles)
552828|NCT00128921|E3|Reported Event|Bortezomib, Cohort c|treatment: 0.7 mg/m^2
552829|NCT00128921|E2|Reported Event|Bortezomib, Cohort b|treatment: 1.0 mg/m^2
552872|NCT00128661|B2|Baseline|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552873|NCT00128661|B1|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552874|NCT00128661|P2|Participant Flow|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552875|NCT00128661|P1|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552876|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552877|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552878|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552879|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552880|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552881|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552882|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552883|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552884|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552885|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552886|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552887|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552888|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552889|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552890|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552891|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552892|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552893|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552894|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552895|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552896|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552897|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552898|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552899|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552900|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552901|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552902|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552903|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552904|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552905|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552906|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552907|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552908|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552909|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552910|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552911|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552912|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552913|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552914|NCT00128661|O2|Outcome|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552915|NCT00128661|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552916|NCT00128661|E2|Reported Event|Havrix Group|Subjects received 3 doses of Havrix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552917|NCT00128661|E1|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix vaccine at study Months 0, 1 and 6. All the vaccine doses were administered intramuscularly in the deltoid region of the non-dominant arm.
552918|NCT00128492|B3|Baseline|Total|Total of all reporting groups
552919|NCT00128492|B2|Baseline|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552920|NCT00128492|B1|Baseline|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552921|NCT00128492|P2|Participant Flow|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552922|NCT00128492|P1|Participant Flow|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552923|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552924|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552925|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552926|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552927|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552928|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552929|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552930|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552931|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
553590|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
552932|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552933|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552934|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552935|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552936|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552937|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552938|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552939|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552940|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552941|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552942|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552943|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552944|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552945|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552946|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552947|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552948|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552949|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552950|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552951|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552952|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552953|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552954|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552955|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
553019|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
552956|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552957|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552958|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552959|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552960|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552961|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552962|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552963|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552964|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552965|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552966|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552967|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552968|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552969|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552970|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552971|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552972|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552973|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552974|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552975|NCT00128492|O2|Outcome|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552976|NCT00128492|O1|Outcome|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552977|NCT00128492|E2|Reported Event|75 mg AZLI Three Times a Day (TID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI TID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~TID = three times daily"
552978|NCT00128492|E1|Reported Event|75 mg AZLI Two Times a Day (BID)|"Participants received up to 9 treatment courses of open-label 75 mg AZLI BID via an investigational nebulizer; each treatment course consisted of 28 days of AZLI and was followed by a 28-day interval off therapy.~BID = twice daily"
552979|NCT00128401|B3|Baseline|Total|Total of all reporting groups
552980|NCT00128401|B2|Baseline|Placebo|
552981|NCT00128401|B1|Baseline|D-cycloserine|
553020|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553591|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
552982|NCT00128401|P2|Participant Flow|Placebo|"Subjects were randomized to receive cognitive behavioral therapy with augmentation of placebo administered on day of therapy session.~All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent."
552983|NCT00128401|P1|Participant Flow|D-cycloserine|Subjects were randomized to receive cognitive behavioral therapy with augmentation of D-cycloserine 50 mg administered on day of therapy session. All subjects underwent the same intake procedures and the same procedures for the assessments for baseline severity. Morever all subjects began the same psychotherapy procedures using cognitive behavioral therapy. After cognitive behavioral therapy was initiated subjects were randomized into a 1:1 ratio by the NIH pharmacy to enter either continued therapy with placebo or continued therapy with the active agent.
552984|NCT00128401|O2|Outcome|Placebo|
552985|NCT00128401|O1|Outcome|D-cycloserine|
552986|NCT00128401|O2|Outcome|Placebo|
552987|NCT00128401|O1|Outcome|D-cycloserine|
552988|NCT00128401|E3|Reported Event|Not Assigned|
552989|NCT00128401|E2|Reported Event|Placebo|
552990|NCT00128401|E1|Reported Event|D-cycloserine|
552991|NCT00128219|B3|Baseline|Total|Total of all reporting groups
552992|NCT00128219|B2|Baseline|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
552993|NCT00128219|B1|Baseline|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
552994|NCT00128219|P2|Participant Flow|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
552995|NCT00128219|P1|Participant Flow|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
552996|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
552997|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
552998|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
552999|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553000|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553001|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553002|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553003|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553004|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553005|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553006|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553007|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553008|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553009|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553010|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553011|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553012|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553013|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553014|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553015|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553016|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553017|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553018|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553126|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553021|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553022|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553023|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553024|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553025|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553026|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553027|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553028|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553029|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553030|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553031|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553032|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553033|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553034|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553035|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553036|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553037|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553038|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553039|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553040|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553041|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553042|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553043|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553044|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553045|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553046|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553047|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553048|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553049|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553050|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553051|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553052|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553053|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553054|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553055|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553056|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
563393|NCT00098059|O2|Outcome|2 to <6 Years|
553057|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553058|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553059|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553060|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553061|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553062|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553063|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553064|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553065|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553066|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553067|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553068|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553069|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553070|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553071|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553072|NCT00128219|O2|Outcome|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine).
553073|NCT00128219|O1|Outcome|GBS III-TT Vaccine|The experimental arm received a single dose of vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid (GBS III-TT).
553074|NCT00128219|E2|Reported Event|Td Vaccine|The control group received a single dose of tetanus and diptheria toxoids adsorbed for adult use (Td vaccine). The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
553075|NCT00128219|E1|Reported Event|GBS III-TT Vaccine|The experimental arm received a single dose of GBS III-TT vaccine administered intramuscularly (IM) containing 50 mcg of GBS III capsular polysaccharide and 32 mcg of tetanus toxoid. The Safety Analysis Cohort is comprised of all vaccinated women, categorized according to the product received, regardless of their randomized assignment.
553076|NCT00128206|B3|Baseline|Total|Total of all reporting groups
553077|NCT00128206|B2|Baseline|Rifampin|rifampin (600 mg orally) given daily for 4 months
553078|NCT00128206|B1|Baseline|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
553079|NCT00128206|P2|Participant Flow|Rifampin|rifampin (600 mg orally) given daily for 4 months
553080|NCT00128206|P1|Participant Flow|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
553081|NCT00128206|O2|Outcome|Rifampin|rifampin (600 mg orally) given daily for 4 months
553082|NCT00128206|O1|Outcome|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
553083|NCT00128206|E2|Reported Event|Rifampin|rifampin (600 mg orally) given daily for 4 months
553084|NCT00128206|E1|Reported Event|Isoniazid|isoniazid (INH) (900 mg orally) given twice weekly for 9 months
553085|NCT00128193|B13|Baseline|Total|Total of all reporting groups
553086|NCT00128193|B12|Baseline|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553087|NCT00128193|B11|Baseline|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553088|NCT00128193|B10|Baseline|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553089|NCT00128193|B9|Baseline|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553090|NCT00128193|B8|Baseline|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553091|NCT00128193|B7|Baseline|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553092|NCT00128193|B6|Baseline|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553093|NCT00128193|B5|Baseline|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553094|NCT00128193|B4|Baseline|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553095|NCT00128193|B3|Baseline|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553096|NCT00128193|B2|Baseline|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553097|NCT00128193|B1|Baseline|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553098|NCT00128193|P12|Participant Flow|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553099|NCT00128193|P11|Participant Flow|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553100|NCT00128193|P10|Participant Flow|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553101|NCT00128193|P9|Participant Flow|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553102|NCT00128193|P8|Participant Flow|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553103|NCT00128193|P7|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553104|NCT00128193|P6|Participant Flow|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553105|NCT00128193|P5|Participant Flow|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553106|NCT00128193|P4|Participant Flow|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553107|NCT00128193|P3|Participant Flow|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553108|NCT00128193|P2|Participant Flow|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553109|NCT00128193|P1|Participant Flow|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553110|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553111|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553112|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553113|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553114|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553115|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553116|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553117|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553118|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553119|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553120|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553121|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553122|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553123|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553124|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553125|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553672|NCT00127413|B4|Baseline|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
553127|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553128|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553129|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553130|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553131|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553132|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553133|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553134|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553135|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553136|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553137|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553138|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553139|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553140|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553141|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553142|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553143|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553144|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553145|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553146|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553147|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553148|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553149|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553150|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553151|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553152|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553153|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553154|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553155|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553156|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553157|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553158|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553159|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553160|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553161|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553162|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553163|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553164|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553165|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553166|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553167|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553168|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553169|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553170|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553171|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553172|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553173|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553174|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553175|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553176|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553177|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553178|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553179|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553180|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553181|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553182|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553183|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553184|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553185|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553186|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553187|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553188|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553189|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553190|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553191|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553192|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553193|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553194|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553195|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553196|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553197|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553198|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553199|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553200|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553201|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553202|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553203|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553204|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553205|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553206|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553207|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553208|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553209|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553210|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553211|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553212|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553213|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553214|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553215|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553216|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553217|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553218|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553219|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553220|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553221|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553222|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553223|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553224|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553225|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553226|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553227|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553228|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553229|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553230|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553231|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553232|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553233|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553234|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553235|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553236|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553237|NCT00128193|O3|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553238|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553239|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553240|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553241|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553242|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553243|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553244|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553245|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553246|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553247|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553248|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553249|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553250|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553251|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553252|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553253|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553254|NCT00128193|O4|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553255|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553256|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553257|NCT00128193|O1|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553258|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553259|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553260|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553261|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553262|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553263|NCT00128193|O1|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553264|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553265|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553266|NCT00128193|O8|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553267|NCT00128193|O7|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553268|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553269|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553270|NCT00128193|O4|Outcome|C1 - High Dose in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553271|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23.
553272|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553273|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553274|NCT00128193|O12|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553275|NCT00128193|O11|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553276|NCT00128193|O10|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553277|NCT00128193|O9|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553278|NCT00128193|O8|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553279|NCT00128193|O7|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553280|NCT00128193|O6|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553281|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553282|NCT00128193|O4|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553283|NCT00128193|O3|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553284|NCT00128193|O2|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553285|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553286|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553287|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553288|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553592|NCT00127842|E1|Reported Event|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553289|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553290|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553291|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553292|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553293|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553294|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553295|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553296|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553297|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553298|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553299|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553300|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553301|NCT00128193|O1|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553302|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553303|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553304|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553305|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553306|NCT00128193|O2|Outcome|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553307|NCT00128193|O1|Outcome|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of M. leprae Cell Wall Antigen (MLCwA), 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553308|NCT00128193|O5|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553309|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553310|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553311|NCT00128193|O2|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553312|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553313|NCT00128193|O6|Outcome|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553314|NCT00128193|O5|Outcome|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553315|NCT00128193|O4|Outcome|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553316|NCT00128193|O3|Outcome|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553317|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553318|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553319|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553320|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553593|NCT00127803|B5|Baseline|Total|Total of all reporting groups
553321|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553322|NCT00128193|O2|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553323|NCT00128193|O1|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553324|NCT00128193|O6|Outcome|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553325|NCT00128193|O5|Outcome|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553326|NCT00128193|O4|Outcome|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553327|NCT00128193|O3|Outcome|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553328|NCT00128193|O2|Outcome|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553329|NCT00128193|O1|Outcome|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553330|NCT00128193|E12|Reported Event|C1b - Low Dose MLSA and MLC in TB Patients|20 TB patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553331|NCT00128193|E11|Reported Event|C1b - Low Dose MLSA and MLC in Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553332|NCT00128193|E10|Reported Event|C1b - Low Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23.
553333|NCT00128193|E9|Reported Event|C1b - Low Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 0.1 mcg MLSA-LAM, 0.1 mcg MLCwA, 2 TU Purified Protein Derivative/RT-23
553334|NCT00128193|E8|Reported Event|CI - High Dose MLSA and MLC in TB Patients|20 tuberculosis (TB) patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553335|NCT00128193|E7|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Healthy Contacts|20 healthy contacts of BL/LL leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553336|NCT00128193|E6|Reported Event|C1 - High Dose MLSA and MLC in BT/TT Leprosy Patients|20 borderline tuberculoid/tuberculoid (BT/TT) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553337|NCT00128193|E5|Reported Event|C1 - High Dose MLSA and MLC in BL/LL Leprosy Patients|20 borderline lepromatous/lepromatous (BL/LL) leprosy patients received 1.0 mcg of MLSA-LAM, 1.0 mcg of MLCwA and 2TU Purified Protein Derivative/RT-23
553338|NCT00128193|E4|Reported Event|B2 - MLC in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLCwA, 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553339|NCT00128193|E3|Reported Event|B1 - MLSA in Healthy Non-Exposed Participants|45 healthy non-exposed participants received 1.0 mcg of MLSA-LAM, 0.1 mcg of MLSA-LAM, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553340|NCT00128193|E2|Reported Event|A2 - MLC in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of M. leprae Cell Wall Antigen (MLCwA), 0.1 mcg of MLCwA, 5 TU Purified Protein Derivative/Tubersol®, saline (NaCl)
553341|NCT00128193|E1|Reported Event|A1 - MLSA in Healthy Non-Exposed Participants|5 healthy non-exposed participants received 1.0 mcg of Mycobacterium (M.) leprae Soluble Antigen (MLSA)-Lipoarabinomannan (LAM), 0.1 mcg of MLSA-LAM, 5 tuberculin units (TU) Purified Protein Derivative(PPD)/Tubersol®, saline (NaCl)
553342|NCT00128180|B3|Baseline|Total|Total of all reporting groups
553343|NCT00128180|B2|Baseline|Placebo|Placebo group
553344|NCT00128180|B1|Baseline|Active|Active drug
553345|NCT00128180|P2|Participant Flow|Placebo|Placebo group
553346|NCT00128180|P1|Participant Flow|Active|Active drug
553347|NCT00128180|O2|Outcome|Placebo|Placebo group
553348|NCT00128180|O1|Outcome|Active|Active drug
553349|NCT00128180|O2|Outcome|Placebo|Placebo group
553350|NCT00128180|O1|Outcome|Active|Active drug
553351|NCT00128180|O2|Outcome|Placebo|Placebo group
553352|NCT00128180|O1|Outcome|Active|Active drug
553353|NCT00128180|O2|Outcome|Placebo|Placebo group
553354|NCT00128180|O1|Outcome|Active|Active drug
553355|NCT00128180|O2|Outcome|Placebo|Placebo group
553356|NCT00128180|O1|Outcome|Active|Active drug
553357|NCT00128180|O2|Outcome|Placebo|Placebo group
553358|NCT00128180|O1|Outcome|Active|Active drug
553359|NCT00128180|O2|Outcome|Placebo|Placebo group
553360|NCT00128180|O1|Outcome|Active|Active drug
553361|NCT00128180|O2|Outcome|Placebo|Placebo group
553362|NCT00128180|O1|Outcome|Active|Active drug
553363|NCT00128180|O2|Outcome|Placebo|Placebo group
553364|NCT00128180|O1|Outcome|Active|Active drug
553365|NCT00128180|O2|Outcome|Placebo|Placebo group
553366|NCT00128180|O1|Outcome|Active|Active drug
553367|NCT00128180|E2|Reported Event|Placebo|Placebo group
553368|NCT00128180|E1|Reported Event|Active|Active drug
553369|NCT00127933|B3|Baseline|Total|Total of all reporting groups
553414|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553370|NCT00127933|B2|Baseline|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553371|NCT00127933|B1|Baseline|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553372|NCT00127933|P2|Participant Flow|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553373|NCT00127933|P1|Participant Flow|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553374|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553375|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553376|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553377|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553378|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553379|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553380|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553381|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553382|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553383|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553384|NCT00127933|O2|Outcome|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553385|NCT00127933|O1|Outcome|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553386|NCT00127933|E2|Reported Event|HER2-Neu Positive|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1 Trastuzumab: loading dose 4 mg/kg, 90-min IV infusion; thereafter, 2 mg/kg, 30-min IV infusion, weekly~HER2-neu positive: capecitabine + docetaxel + trastuzumab~Duration: Four 3-week treatment cycles"
553387|NCT00127933|E1|Reported Event|HER2-Neu Negative|"Dose and route per treatment cycle (Q3W):~Capecitabine: 825 mg/m2, orally, twice daily, days 1-14 Docetaxel: 75 mg/m2, IV infusion, day 1~HER2-neu negative: capecitabine + docetaxel~Duration: Four 3-week treatment cycles"
553388|NCT00127855|B6|Baseline|Total|Total of all reporting groups
553389|NCT00127855|B5|Baseline|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553390|NCT00127855|B4|Baseline|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553391|NCT00127855|B3|Baseline|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553392|NCT00127855|B2|Baseline|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553393|NCT00127855|B1|Baseline|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553394|NCT00127855|P5|Participant Flow|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553395|NCT00127855|P4|Participant Flow|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553396|NCT00127855|P3|Participant Flow|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553397|NCT00127855|P2|Participant Flow|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553398|NCT00127855|P1|Participant Flow|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553399|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553400|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553401|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553402|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553403|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553404|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553405|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553406|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553407|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553408|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553409|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553410|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553411|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553412|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553413|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553415|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553416|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553417|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553418|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553419|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553420|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553421|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553422|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553423|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553424|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553425|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553426|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553427|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553428|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553429|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553430|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553431|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553432|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553433|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553434|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553435|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553667|NCT00127530|O2|Outcome|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
553436|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553437|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553438|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553439|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553440|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553441|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553442|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553443|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553444|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553445|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553446|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553447|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553448|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553449|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553450|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553451|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553452|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553453|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553454|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553455|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553456|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553668|NCT00127530|O1|Outcome|Placebo- Sugar Pill|Placebo control group
553457|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553458|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553459|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553460|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553461|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553462|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553463|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553464|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553465|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553466|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553467|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553468|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553469|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553470|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553471|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553472|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553473|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553474|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553475|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553476|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553477|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
563394|NCT00098059|O1|Outcome|1 to < 2 Years|
553478|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553479|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553480|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553481|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553482|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553483|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553484|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553485|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553486|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553487|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553488|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553489|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553490|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553491|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553492|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553493|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553494|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553495|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553496|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553497|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553498|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
565247|NCT00094575|E2|Reported Event|Open Repair|Standard Open Repair
553499|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553500|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553501|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553502|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553503|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553504|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553505|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553506|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553507|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553508|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553509|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553510|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553511|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553512|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553513|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553514|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553515|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553516|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553517|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553518|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553519|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553669|NCT00127530|E2|Reported Event|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
553520|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553521|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553522|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553523|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553524|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553525|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553526|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553527|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553528|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553529|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553530|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553531|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553532|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553533|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553534|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553535|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553536|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553537|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553538|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553539|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553540|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553670|NCT00127530|E1|Reported Event|Placebo- Sugar Pill|Placebo control group
553541|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553542|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553543|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553544|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553545|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553546|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553547|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553548|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553549|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553550|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553551|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553552|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553553|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553554|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553555|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553556|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553557|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553558|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553559|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553560|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553561|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553671|NCT00127413|B5|Baseline|Total|Total of all reporting groups
553562|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553563|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553564|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553565|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553566|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553567|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553568|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553569|NCT00127855|O5|Outcome|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553570|NCT00127855|O4|Outcome|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553571|NCT00127855|O3|Outcome|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553572|NCT00127855|O2|Outcome|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553573|NCT00127855|O1|Outcome|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553574|NCT00127855|E5|Reported Event|ActHIB Group|Subjects were primed with ActHIB co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553575|NCT00127855|E4|Reported Event|Menjugate Group|Subjects were primed with Menjugate co-administered with Infanrix Penta and ActiHIB according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553576|NCT00127855|E3|Reported Event|MenHibrix Formulation 3 Group|Subjects were primed with MenHibrix formulation 3 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553577|NCT00127855|E2|Reported Event|MenHibrix Formulation 2 Group|Subjects were primed with MenHibrix formulation 2 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553578|NCT00127855|E1|Reported Event|MenHibrix Formulation 1 Group|Subjects were primed with MenHibrix formulation 1 co-administered with Infanrix Penta and Prevenar according to a 2-4-6 months of age schedule, and received a polysaccharide challenge dose (1/5th dose of MenACWY polysaccharide vaccine co-administered with 10 µg dose of plain PRP) at 12 months of age.
553579|NCT00127842|B1|Baseline|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553580|NCT00127842|P1|Participant Flow|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553581|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553582|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553583|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553584|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553585|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553586|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
553587|NCT00127842|O1|Outcome|Enbrel|Open-label etanercept administered by subcutaneous injection at a dose of 50 mg/week for 24 months.
566851|NCT00089661|E1|Reported Event|Placebo|
553594|NCT00127803|B4|Baseline|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553595|NCT00127803|B3|Baseline|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553596|NCT00127803|B2|Baseline|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553597|NCT00127803|B1|Baseline|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553598|NCT00127803|P4|Participant Flow|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553599|NCT00127803|P3|Participant Flow|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553600|NCT00127803|P2|Participant Flow|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553601|NCT00127803|P1|Participant Flow|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553602|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553603|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553604|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553605|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553606|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553607|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553608|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553609|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553610|NCT00127803|O4|Outcome|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553611|NCT00127803|O3|Outcome|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553612|NCT00127803|O2|Outcome|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553613|NCT00127803|O1|Outcome|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553614|NCT00127803|E4|Reported Event|High Dose Vaccine Group|Participants who received 3 doses of vaccine containing 50 μg C. difficile toxoid on Days 0, 28, and 56.
553615|NCT00127803|E3|Reported Event|Medium Dose Vaccine Group|Participants who received 3 doses of vaccine containing 10 μg C. difficile toxoid on Days 0, 28, and 56.
553616|NCT00127803|E2|Reported Event|Low Dose Vaccine Group|Participants who received 3 doses of vaccine containing 2 μg C. difficile toxoid on Days 0, 28, and 56.
553617|NCT00127803|E1|Reported Event|Placebo Group|Participants who received 3 doses of vaccine diluent (placebo) on Days 0, 28, and 56.
553618|NCT00127790|B5|Baseline|Total|Total of all reporting groups
553619|NCT00127790|B4|Baseline|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553620|NCT00127790|B3|Baseline|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553621|NCT00127790|B2|Baseline|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553622|NCT00127790|B1|Baseline|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553623|NCT00127790|P4|Participant Flow|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553624|NCT00127790|P3|Participant Flow|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553625|NCT00127790|P2|Participant Flow|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553626|NCT00127790|P1|Participant Flow|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553627|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553628|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553629|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
571627|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
553630|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553631|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553632|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553633|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553634|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553635|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553636|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553637|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553638|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553639|NCT00127790|O4|Outcome|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553640|NCT00127790|O3|Outcome|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553641|NCT00127790|O2|Outcome|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553642|NCT00127790|O1|Outcome|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553643|NCT00127790|E4|Reported Event|Wait-List Control (WL)|Waitlist Control condition (WL) with no contact during the intervention period.
553644|NCT00127790|E3|Reported Event|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)|Cognitive-Behavioral Therapy for Insomnia & Pain (CBT-I/P)consisting of 10 individual sessions and including sleep education, pain education, sleep restriction therapy, stimulus control therapy, sleep hygiene, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553645|NCT00127790|E2|Reported Event|Cognitive-Behavioral Therapy for Pain (CBT-P)|Cognitive-Behavioral Therapy for Pain (CBT-P)consisting of 10 individual sessions and including pain education, pacing strategies, problem solving, goal setting, cognitive therapy, relaxation training and relapse prevention.
553646|NCT00127790|E1|Reported Event|Cognitive-Behavioral Therapy for Insomnia (CBT-I)|Cognitive-Behavioral Therapy for Insomnia (CBT-I)consisting of 10 individual sessions and including sleep education, sleep restriction therapy, stimulus control therapy, sleep hygiene, cognitive therapy, relaxation training and relapse prevention.
553647|NCT00127712|B3|Baseline|Total|Total of all reporting groups
553648|NCT00127712|B2|Baseline|Control|Control group
553649|NCT00127712|B1|Baseline|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553650|NCT00127712|P2|Participant Flow|Control|Control group
553651|NCT00127712|P1|Participant Flow|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553652|NCT00127712|O2|Outcome|Control|Control group
553653|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553654|NCT00127712|O2|Outcome|Control|Control group
553655|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553656|NCT00127712|O2|Outcome|Control|Control group
553657|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553658|NCT00127712|O2|Outcome|Control|Control group
553659|NCT00127712|O1|Outcome|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553660|NCT00127712|E2|Reported Event|Control|Control group
553661|NCT00127712|E1|Reported Event|Amiodarone|Determine if amiodarone is effective for prevention of atrial fibrillation ater pulmonary resection surgery
553662|NCT00127530|B3|Baseline|Total|Total of all reporting groups
553663|NCT00127530|B2|Baseline|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
553664|NCT00127530|B1|Baseline|Placebo- Sugar Pill|Placebo control group
553665|NCT00127530|P2|Participant Flow|Fampridine-SR|10 milligram (mg) tablet twice a day (b.i.d.)
553666|NCT00127530|P1|Participant Flow|Placebo- Sugar Pill|Placebo control group
553673|NCT00127413|B3|Baseline|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
553674|NCT00127413|B2|Baseline|Cognitive Processing Therapy-PTSD|Cognitive processing therapy for PTSD
553675|NCT00127413|B1|Baseline|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
553676|NCT00127413|P4|Participant Flow|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
553677|NCT00127413|P3|Participant Flow|Cognitive Behavioral Therapy - Integrated|Integrated treatment for comorbid chronic pain and PTSD
553678|NCT00127413|P2|Participant Flow|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
553679|NCT00127413|P1|Participant Flow|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
553680|NCT00127413|O4|Outcome|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider
553681|NCT00127413|O3|Outcome|Cognitive Behavioral Therapy - Integrated|Cognitive Behavioral Therapy - Integrated treatment for pain and PTSD
553682|NCT00127413|O2|Outcome|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
553683|NCT00127413|O1|Outcome|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
553684|NCT00127413|E4|Reported Event|Treat as Usual|Participants received care for pain and PTSD as usual from their primary care provider.
553685|NCT00127413|E3|Reported Event|Cognitive Behavioral Therapy-Integrated|Integrated treatment for comorbid chronic pain and PTSD
553686|NCT00127413|E2|Reported Event|Cognitive Processing Therapy - PTSD|Cognitive processing therapy for PTSD
553687|NCT00127413|E1|Reported Event|Cognitive Behavioral Therapy - Pain|Cognitive Behavioral Therapy targeting chronic pain
553688|NCT00127218|B3|Baseline|Total|Total of all reporting groups
553689|NCT00127218|B2|Baseline|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553690|NCT00127218|B1|Baseline|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553691|NCT00127218|P2|Participant Flow|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553692|NCT00127218|P1|Participant Flow|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553693|NCT00127218|O2|Outcome|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553694|NCT00127218|O1|Outcome|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553695|NCT00127218|E2|Reported Event|Placebo Plus Statin|placebo plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553696|NCT00127218|E1|Reported Event|Niacin Plus Statin|Extended release niacin (1500 mg daily) plus statin therapy to reach their National Cholesterol Education Program-deﬁned low density lipoprotein (LDL)cholesterol target
553697|NCT00127192|B6|Baseline|Total|Total of all reporting groups
553698|NCT00127192|B5|Baseline|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
553699|NCT00127192|B4|Baseline|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553700|NCT00127192|B3|Baseline|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553701|NCT00127192|B2|Baseline|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553702|NCT00127192|B1|Baseline|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553703|NCT00127192|P5|Participant Flow|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
553704|NCT00127192|P4|Participant Flow|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553705|NCT00127192|P3|Participant Flow|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553706|NCT00127192|P2|Participant Flow|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553707|NCT00127192|P1|Participant Flow|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553708|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
553709|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553710|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553711|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553712|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553713|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
571628|NCT00064844|E2|Reported Event|Nicotine Patch Plus Placebo Gum|
553714|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553715|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553716|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553717|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553718|NCT00127192|O5|Outcome|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
553719|NCT00127192|O4|Outcome|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553720|NCT00127192|O3|Outcome|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553721|NCT00127192|O2|Outcome|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553722|NCT00127192|O1|Outcome|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553723|NCT00127192|E5|Reported Event|Placebo|The Placebo group includes data from all patients randomized to receive treatment with matching placebo orally once daily.
553724|NCT00127192|E4|Reported Event|Sitagliptin 200 mg QD|The Sitagliptin 200 mg group includes data from all patients randomized to receive treatment with sitagliptin 200 mg orally once daily (QD=once daily).
553725|NCT00127192|E3|Reported Event|Sitagliptin 100 mg QD|The Sitagliptin 100 mg group includes data from all patients randomized to receive treatment with sitagliptin 100 mg orally once daily (QD=once daily).
553726|NCT00127192|E2|Reported Event|Sitagliptin 50 mg QD|The Sitagliptin 50 mg group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
553727|NCT00127192|E1|Reported Event|Sitagliptin 25 mg QD|The Sitagliptin 25 mg group includes data from all patients randomized to receive treatment with sitagliptin 25 mg orally once daily (QD=once daily).
553728|NCT00127166|B3|Baseline|Total|Total of all reporting groups
553729|NCT00127166|B2|Baseline|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
553730|NCT00127166|B1|Baseline|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
553731|NCT00127166|P2|Participant Flow|Salmeterol / Montelukast|Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
553732|NCT00127166|P1|Participant Flow|Montelukast / Salmeterol|Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks followed by a 2-week washout period (salmeterol matching placebo + montelukast matching placebo). Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks. Inhaled Fluticasone 100 mcg twice daily throughout the study.
553733|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
553734|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
553735|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
553736|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
553737|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
553738|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
553739|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
553740|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
553741|NCT00127166|O2|Outcome|Salmeterol|Salmeterol DPI 50 mcg twice daily, inhaled Fluticasone 100 mcg twice daily.
553742|NCT00127166|O1|Outcome|Montelukast|Montelukast 5 mg oral tablet once daily, inhaled Fluticasone 100 mcg twice daily.
553743|NCT00127166|E2|Reported Event|Salmeterol|"Period I- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 mcg twice daily for 4 weeks.~Period II- Montelukast matching placebo oral tablet once daily and Salmeterol DPI 50 micrograms (mcg) twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
553744|NCT00127166|E1|Reported Event|Montelukast|"Period I- Montelukast 5 milligrams (mg) oral tablet once daily and Salmeterol matching placebo dry powder inhaler (DPI) twice daily for 4 weeks.~Period II- Montelukast 5 mg oral tablet once daily and Salmeterol matching placebo DPI twice daily for 4 weeks.~Inhaled Fluticasone 100 mcg twice daily throughout the study."
553745|NCT00127101|B7|Baseline|Total|Total of all reporting groups
553746|NCT00127101|B6|Baseline|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
553747|NCT00127101|B5|Baseline|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
553748|NCT00127101|B4|Baseline|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
553749|NCT00127101|B3|Baseline|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
553750|NCT00127101|B2|Baseline|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553751|NCT00127101|B1|Baseline|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553752|NCT00127101|P6|Participant Flow|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
553753|NCT00127101|P5|Participant Flow|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
553754|NCT00127101|P4|Participant Flow|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
553755|NCT00127101|P3|Participant Flow|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
553756|NCT00127101|P2|Participant Flow|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553757|NCT00127101|P1|Participant Flow|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553758|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
553759|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
553760|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
553761|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
553762|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553763|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553764|NCT00127101|O6|Outcome|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
553765|NCT00127101|O5|Outcome|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
553766|NCT00127101|O4|Outcome|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
553767|NCT00127101|O3|Outcome|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
553768|NCT00127101|O2|Outcome|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553769|NCT00127101|O1|Outcome|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553770|NCT00127101|E6|Reported Event|Cohort 7|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene daily for 7 days per week [150 milligrams (Cycle 1) 225 milligrams (Cycle 2-6)]
553771|NCT00127101|E5|Reported Event|Cohort 6|Vorinostat 400 milligrams daily for 7 days per week + Bexarotene 150 milligrams daily for 7 days per week
553772|NCT00127101|E4|Reported Event|Cohort 2b|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 300 milligrams/meter[2] daily x 7 days per week
553773|NCT00127101|E3|Reported Event|Cohort 2a|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 225 milligrams/meter[2] daily x 7 days per week
553774|NCT00127101|E2|Reported Event|Cohort 2|Vorinostat 300 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553775|NCT00127101|E1|Reported Event|Cohort 1|Vorinostat 200 milligrams daily for 7 days per week + Bexarotene 150 milligrams/meter[2] daily x 7 days per week
553776|NCT00127036|B3|Baseline|Total|Total of all reporting groups
553777|NCT00127036|B2|Baseline|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553778|NCT00127036|B1|Baseline|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553779|NCT00127036|P2|Participant Flow|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553780|NCT00127036|P1|Participant Flow|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553781|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553782|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553783|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553784|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553785|NCT00127036|O2|Outcome|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553786|NCT00127036|O1|Outcome|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
555704|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
553787|NCT00127036|E2|Reported Event|XELIRI + Bevacizumab|Arm B: Anticipated 75 Patients - Drug: XELIRI (which is Capecitabine + Irinotecan) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553788|NCT00127036|E1|Reported Event|XELOX + Bevacizumab|Arm A: Anticipated 75 Patients - Drug: XELOX (which is Capecitabine + Oxaliplatin) by mouth + Bevacizumab intravenously as outlined in Intervention Description - To Disease Progression
553789|NCT00126776|B3|Baseline|Total|Total of all reporting groups
553790|NCT00126776|B2|Baseline|Usual Care|usual care
553791|NCT00126776|B1|Baseline|Disease Management for COPD|disease management for COPD
553792|NCT00126776|P2|Participant Flow|Usual Care|usual care
553793|NCT00126776|P1|Participant Flow|Disease Management for COPD|disease management for COPD
553794|NCT00126776|O2|Outcome|Usual Care|usual care
553795|NCT00126776|O1|Outcome|Disease Management for COPD|disease management for COPD
553796|NCT00126750|B3|Baseline|Total|Total of all reporting groups
553797|NCT00126750|B2|Baseline|Control Arm/Group|Providers from eligible clinics that were allocated to the control arm.
553798|NCT00126750|B1|Baseline|Intervention Arm/Group|Providers from eligible clinics that were allocated to the intervention arm.
553799|NCT00126750|P2|Participant Flow|Control Group|Providers in control clinics were sent a link to an existing VA Web site that contained links to a wide range of clinical guidelines for various medical conditions.
553800|NCT00126750|P1|Participant Flow|Intervention Group|The intervention included a multicomponent Web site and pushed e-mail cues with educational content.
553801|NCT00126750|O2|Outcome|Control|Control Providers received a link to VA practice guidelines.
553802|NCT00126750|O1|Outcome|Intervention|Intervention Providers received an interactive, educational website and motivational reminders.
553803|NCT00126750|E2|Reported Event|Control Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
553804|NCT00126750|E1|Reported Event|Intervention Group|Because this was an RCT of clinics and providers utilization of web-based intervention, no serious (or non-serious) adverse events were collected.
553805|NCT00126737|B5|Baseline|Total|Total of all reporting groups
553806|NCT00126737|B4|Baseline|Usual Care|Usual care and non-specific health information (C). No intervention.
553807|NCT00126737|B3|Baseline|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553808|NCT00126737|B2|Baseline|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553809|NCT00126737|B1|Baseline|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise Program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553810|NCT00126737|P4|Participant Flow|Usual Care|Usual care and non-specific health information (C). No intervention.
553811|NCT00126737|P3|Participant Flow|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553812|NCT00126737|P2|Participant Flow|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553813|NCT00126737|P1|Participant Flow|Weight Control Nutritional and Home-based Exercise Program|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises"
553814|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
553815|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553816|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553817|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553818|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
553819|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553820|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553821|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553822|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
553823|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553824|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553825|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise pr|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553826|NCT00126737|O4|Outcome|Usual Care|Usual Care and non-specific health information (C). No intervention.
553827|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553828|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553829|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553830|NCT00126737|O4|Outcome|Usual Care|Usual care and non-specific health information (C). No intervention.
553831|NCT00126737|O3|Outcome|Home-based Exercise Program|"Group assigned to a home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553832|NCT00126737|O2|Outcome|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553833|NCT00126737|O1|Outcome|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553834|NCT00126737|E4|Reported Event|Usual Care|Usual Care and non-specific health information (C). No intervention.
553835|NCT00126737|E3|Reported Event|Home-based Exercise Program|"Group assigned to a Home-based exercise program (Ex).~Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553836|NCT00126737|E2|Reported Event|Weight Control Nutritional Program|"Group assigned to a Weight Control Nutritional Program (WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables."
553837|NCT00126737|E1|Reported Event|Weight Control Nutritional and Home-based Exercise Pro|"Group assigned to both a Weight Control Nutritional Program and home-based exercise program (Ex+WC).~Weight Control Nutritional Program: a week of food diary and information about dietary fat intake and proper proportions of vegetables Home-based exercise program: 24 week home-based exercise program encompassed aerobic exercises, isometric and isotonic exercises, and stretching exercises."
553838|NCT00126659|B4|Baseline|Total|Total of all reporting groups
553839|NCT00126659|B3|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
553840|NCT00126659|B2|Baseline|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
553841|NCT00126659|B1|Baseline|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
553842|NCT00126659|P3|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
553843|NCT00126659|P2|Participant Flow|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
553844|NCT00126659|P1|Participant Flow|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
553845|NCT00126659|O3|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 29|Group 3: Four weeks Sorafenib 400 mg orally mouth twice a day, Cytoreductive Nephrectomy, two weeks rest, 6 weeks Sorafenib
553846|NCT00126659|O2|Outcome|Sorafenib + Cytoreductive Nephrectomy Day 8|Group 2: One week Sorafenib 400 mg orally mouth twice a day, cytoreductive nephrectomy, two weeks rest, 9 weeks Sorafenib
553847|NCT00126659|O1|Outcome|Cytoreductive Nephrectomy Day 0|Group 1: Immediate cytoreductive nephrectomy, two weeks rest, and 10 weeks Sorafenib 400 mg orally mouth twice a day.
553848|NCT00126659|E1|Reported Event|Sorafenib + Cytoreductive Nephrectomy|All participants received Sorafenib 400 mg orally mouth twice a day for a total of 10 weeks over the course of the study and had surgical procedure Cytoreductive Nephrectomy before treatment with Sorafenib or in between courses of Sorafenib
553849|NCT00126594|B3|Baseline|Total|Total of all reporting groups
553850|NCT00126594|B2|Baseline|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553851|NCT00126594|B1|Baseline|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553852|NCT00126594|P2|Participant Flow|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553853|NCT00126594|P1|Participant Flow|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553854|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553855|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553856|NCT00126594|O1|Outcome|Sorafenib Tosylate or Sorafenib Plus Interferon|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28 and Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553857|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553858|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553859|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553860|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553861|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553862|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553863|NCT00126594|O2|Outcome|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553864|NCT00126594|O1|Outcome|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553865|NCT00126594|E2|Reported Event|Sorafenib Tosylate, Recombinant Interferon Alfa-2b|Arm II: Sorafenib as in Arm I and low-dose Interferon alfa-2b 0.5 million units subcutaneously twice daily on days 1-28.
553866|NCT00126594|E1|Reported Event|Sorafenib Tosylate|Arm I: Oral Sorafenib 400 mg twice daily on days 1-28.
553867|NCT00126581|B3|Baseline|Total|Total of all reporting groups
553868|NCT00126581|B2|Baseline|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553869|NCT00126581|B1|Baseline|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553870|NCT00126581|P2|Participant Flow|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553871|NCT00126581|P1|Participant Flow|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553872|NCT00126581|O2|Outcome|Wild Type|
553873|NCT00126581|O1|Outcome|Mutant|
553874|NCT00126581|O2|Outcome|Wild Type|
553875|NCT00126581|O1|Outcome|Mutant|
553876|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553877|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553878|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553879|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553880|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553881|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553882|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553883|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553884|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553885|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553886|NCT00126581|O2|Outcome|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553887|NCT00126581|O1|Outcome|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553888|NCT00126581|E2|Reported Event|Arm B: Erlotinib/Carboplatin/Paclitaxel|Patients receive erlotinib as in arm I. Patients also receive paclitaxel IV over 1-3 hours and carboplatin IV over 15-30 minutes on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of 6 courses of treatment, patients may continue to receive erlotinib alone as above.
553889|NCT00126581|E1|Reported Event|Arm A: Erlotinib|Patients receive oral erlotinib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
553890|NCT00126568|B1|Baseline|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553891|NCT00126568|P1|Participant Flow|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553892|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553893|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553894|NCT00126568|O1|Outcome|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553895|NCT00126568|E1|Reported Event|BAY 43-9006|BAY 43-9006 (sorafenib) will be administered on a fixed daily oral dosing schedule of 400 mg twice daily. A cycle of therapy will be considered 28 days (4 weeks / 1 month).
553896|NCT00126555|B1|Baseline|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
553897|NCT00126555|P1|Participant Flow|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
553898|NCT00126555|O4|Outcome|Maintenance Phase|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
553899|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
553900|NCT00126555|O2|Outcome|Induction Phase With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
553901|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
553902|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.
553903|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
553904|NCT00126555|O4|Outcome|Maintenance|Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase (Gefitinib Induction dose 250 mg/day or 500 mg/day dose escalation).
553905|NCT00126555|O3|Outcome|Radiation With Gefitinib|Participants received Radiation with Gefitinib therapy following evaluation for clinical response and resectability at Induction (with or without dose doubling): Resectable strata who achieved at least stable disease received surgery followed by radiation treatment and 12 additional months of Gefitinib post radiation; and the Unresectable strata who achieved at least stable disease received concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated).
553906|NCT00126555|O2|Outcome|Induction With Dose Escalation|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib starting dose 250 mg/day with doubling to 500 mg/day for no response Day 15.
553959|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
553907|NCT00126555|O1|Outcome|Induction Phase|Participants received Gefitinib Induction therapy daily for 2 months then were evaluated for clinical response and resectability: Gefitinib Induction Phase dose 250 mg/day with no doubling for no response at Day 15.
553908|NCT00126555|O1|Outcome|Gefitinib, Radiotherapy, Surgery|"Gefitinib Induction therapy daily for 2 months then evaluated for clinical response and resectability: Resectable strata who have achieved at least stable disease receive surgery followed by radiation treatment, if indicated, and 12 additional months of Gefitinib post radiation. Unresectable strata who have achieved at least stable disease receive concomitant radiation/Gefitinib and 12 additional months of Gefitinib post-radiation (or post-surgery if surgery is indicated). Maintenance Phase of Gefitinib starts at same dose level as last dosing of Induction phase.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
553909|NCT00126555|E1|Reported Event|Gefitinib, Radiotherapy, Surgery|"Resectable Strata: Induction Gefitinib (60 days), Surgery followed 3-6 weeks later by daily Radiotherapy 5 days a week for approximately 6-7 weeks then after 4 weeks restart Maintenance Gefitinib for up to additional 12 months post radiation.~Unresectable Strata: Concomitant Radiation/Gefitinib and post-radiation (or post-surgery if surgery is indicated) Gefitinib. Daily Radiotherapy 5 days a week for approximately 6-7 weeks concurrent with Maintenance Gefitinib dose daily up to 12 months.~Gefitinib Induction Phase starting dose 250 mg/day, possible doubling to 500 mg/day for no response Day 15; Maintenance dose post radiation starts at same dose level as last dosing of Induction Phase."
553910|NCT00126503|B3|Baseline|Total|Total of all reporting groups
553911|NCT00126503|B2|Baseline|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
553912|NCT00126503|B1|Baseline|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
553913|NCT00126503|P2|Participant Flow|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
553914|NCT00126503|P1|Participant Flow|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
553915|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1. No Phase II patients were in the Phase I cohort.
553916|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability. No Phase I patients moved to the Phase II cohort.
553917|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
553918|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
553919|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
553920|NCT00126503|O2|Outcome|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
553921|NCT00126503|O1|Outcome|Phase I|The highest dose in milligrams (mg) of BAY 43-9006 (Sorafenib) in combination with Bevacizumab while maintaining tolerability. The highest dose in milligrams/kilograms of body weight mg/kg of Bevacizumab in combination with BAY 43-9006 (Sorafenib) while maintaining tolerability.
553922|NCT00126503|O1|Outcome|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3-day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
553923|NCT00126503|E2|Reported Event|Phase II|Sorafenib will be taken orally once daily at 200 mg beginning on day -14 and continued for 28 days per cycle. There is no planned interruption. Bevacizumab 5mg/kg IV will be administered every 14 days (+/- 3 days) beginning on day 1.
553924|NCT00126503|E1|Reported Event|Phase I|Sorafenib will be taken orally twice daily beginning on day 1 and continued for 28 days which will be defined as a cycle. Bevacizumab will be administered once every 14 days (with up to a 3 day window before or after 14 days to allow for unforeseen scheduling problems) beginning on day 1.
553925|NCT00126490|B1|Baseline|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
553926|NCT00126490|P1|Participant Flow|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
553927|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
553928|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
553929|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
553930|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
553931|NCT00126490|O1|Outcome|Treatment (Bevacizumab, Aldesleukin)|Patients received bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also received interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeated every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then received bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeated every 12 weeks in the absence of disease progression or unacceptable toxicity.
553932|NCT00126490|E1|Reported Event|Treatment (Bevacizumab, Aldesleukin)|Patients receive bevacizumab IV over 30-90 minutes on day 1 in weeks 1, 3, 5, 7, 9, and 11. Patients also receive interleukin-2 subcutaneously on days 1-5 in weeks 5-10. Treatment repeats every 12 weeks for up to 2 courses in the absence of disease progression or unacceptable toxicity. Patients with stable or responding disease then receive bevacizumab alone in weeks 1, 3, 5, 7, 9, and 11. Courses with bevacizumab alone repeat every 12 weeks in the absence of disease progression or unacceptable toxicity.
553933|NCT00126425|B3|Baseline|Total|Total of all reporting groups
553934|NCT00126425|B2|Baseline|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at no risk of heart failure.
553935|NCT00126425|B1|Baseline|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose, to participants who were at a high risk of heart failure.
553936|NCT00126425|P2|Participant Flow|AdreView--Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
553937|NCT00126425|P1|Participant Flow|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
553938|NCT00126425|O2|Outcome|AdreView-Heart Failure Group With Low H/M Ratio|Participants in HF group who had low H/M ratio (less than 1.6)
553939|NCT00126425|O1|Outcome|AdreView-Heart Failure Group With High H/M Ratio|Participants in HF group who had high H/M ratio (more than or equal to 1.6)
553940|NCT00126425|E2|Reported Event|AdreView --Control Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
553941|NCT00126425|E1|Reported Event|AdreView--Heart Failure Group|123I-mIBG (meta-iodobenzylguanidine): 10 mCi as a single intravenous dose.
553942|NCT00126191|B3|Baseline|Total|Total of all reporting groups
553943|NCT00126191|B2|Baseline|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
553944|NCT00126191|B1|Baseline|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
553945|NCT00126191|P2|Participant Flow|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
553946|NCT00126191|P1|Participant Flow|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
553947|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
553948|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
553949|NCT00126191|O2|Outcome|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
553950|NCT00126191|O1|Outcome|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
553951|NCT00126191|E2|Reported Event|High Risk|Regimen A followed by Regimen B. Cycles A and B will then be repeated (ABAB).
553952|NCT00126191|E1|Reported Event|Low Risk|Regimen A. Single focus of disease less than 10 cm in greatest dimension and a normal LDH. Participants at low risk received three cycles of Regimen A (AAA).
553953|NCT00126126|B3|Baseline|Total|Total of all reporting groups
553954|NCT00126126|B2|Baseline|Wait List Control Group|Those subjects who were randomized to the wait-list control group.
553955|NCT00126126|B1|Baseline|Intervention|Those subjects who were randomized to receive the Evidence Based Amputee Rehabilitation (EBAR) Program
553956|NCT00126126|P2|Participant Flow|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
553957|NCT00126126|P1|Participant Flow|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
553958|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
553960|NCT00126126|O2|Outcome|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
553961|NCT00126126|O1|Outcome|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
553962|NCT00126126|E2|Reported Event|Wait-List Control Group|These individuals waited 8 weeks in order to begin the intervention.
553963|NCT00126126|E1|Reported Event|Intervention|"Evidence Based Amputee Rehabilitation Program~Exercise: Evidence Based Amputee Rehabilitation Program"
553964|NCT00126113|B3|Baseline|Total|Total of all reporting groups
553965|NCT00126113|B2|Baseline|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553966|NCT00126113|B1|Baseline|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553967|NCT00126113|P2|Participant Flow|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553968|NCT00126113|P1|Participant Flow|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553969|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553970|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553971|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553972|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553973|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553974|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553975|NCT00126113|O2|Outcome|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553976|NCT00126113|O1|Outcome|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553977|NCT00126113|E2|Reported Event|Standard Educational Counseling|Standard educational counseling consisting of explanation of hearing tests
553978|NCT00126113|E1|Reported Event|PPT-based Counseling|Counseling based on Performance-Perceptual Discrepancy (PPDIS) consisting of explanation of hearing tests plus recommendations based on PPDIS
553979|NCT00125957|B3|Baseline|Total|Total of all reporting groups
553980|NCT00125957|B2|Baseline|Placebo-Wellbutrin|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to Wellbutrin 100 mg twice daily (BID). At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
553981|NCT00125957|B1|Baseline|Wellbutrin-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg twice daily (BID) of Wellbutrin) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
553982|NCT00125957|P2|Participant Flow|Placebo First, Then Wellbutrin|Subjects randomly assigned to the Placebo first, then Wellbutrin group will receive placebo until Week 4 when they will cross-over to active drug. At Week 4, subjects will be assigned 100mg Wellbutrin BID. At Week 5, Subjects will be increased to 150mg Wellbutrin BID unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of Wellbutrin qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on bupropion 100mg BID. Subject will continue on the assigned dosage until Week 8 of study.
553983|NCT00125957|P1|Participant Flow|Wellbutrin First, Then Placebo|Subjects randomly assigned to the Wellbutrin first, then Placebo group will receive 100mg BID of Wellbutrin at the first visit following intake (Week 0).Subjects will be increased to 150mg Wellbutrin BID at Week 1 unless moderate/severe side effects are reported. If subject and rater classify 1+ symptom as severe or 2+ symptoms as moderate, subject will continue on 100mg of bupropion qAM. If subject and rater classify 1+ symptom as moderate or 2+ mild as moderate, subject will continue on Wellbutrin 100mg BID. At Week 4, subjects will cross-over to placebo and will continue to take placebo until Week 8.
553984|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
553985|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
553986|NCT00125957|O2|Outcome|Placebo First, Then Wellbutrin|Subjects randomly assigned to Treatment B will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
553987|NCT00125957|O1|Outcome|Wellbutrin First, Then Placebo|Subjects randomly assigned to Treatment A will receive Wellbutrin or placebo at Week 1 and will cross over to Wellbutrin or placebo at week 4.
553988|NCT00125957|E2|Reported Event|Placebo-Bupropion|Subjects randomly assigned to this arm are given placebo at week 1. They will continue on placebo until week 4, at which time they will cross-over to bupropion 100 mg BID. At week 5, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. Subjects continue on active drug until end of study at week 8.
553989|NCT00125957|E1|Reported Event|Bupropion-Placebo|Study subjects randomly assigned to this arm of the study will begin on active drug (100 mg BID bupropion) at week 1. At week 2, active drug is increased to 150mg BID unless subject reports one or more symptoms that are classified as moderate-severe. At week 4, subjects cross over to placebo for remainder of study. Subjects continue on placebo until end of study at week 8.
553990|NCT00125931|B1|Baseline|Open Label|Open label treatment with pentazocine
553991|NCT00125931|P1|Participant Flow|Treatment Group|Open label group with pentazocine treatment.
553992|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
553993|NCT00125931|O1|Outcome|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
553994|NCT00125931|E1|Reported Event|Open Label Group|Mania symptoms with pentazocine compared to baseline symptoms.
553995|NCT00125619|B3|Baseline|Total|Total of all reporting groups
553996|NCT00125619|B2|Baseline|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
553997|NCT00125619|B1|Baseline|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
553998|NCT00125619|P2|Participant Flow|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
553999|NCT00125619|P1|Participant Flow|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554000|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554001|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554002|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554003|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554004|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554005|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554006|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554007|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554008|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554009|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554010|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554011|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554012|NCT00125619|O2|Outcome|Arm 1: Therapist Assisted|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554013|NCT00125619|O1|Outcome|Arm 2: Robot-assisted|"Rehabilitation for Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554014|NCT00125619|E2|Reported Event|Arm 1|Rehabilitation for Post-Stroke hemiparesis Body-weight Supported Locomotor Training (manual, with therapist assistance for movement of the paretic leg)
554015|NCT00125619|E1|Reported Event|ARM2|"Rehabilitation got Post-stroke Hemiparesis~Robotic-driven Locomotor Training for Gait (a robotic device called the Lokomat guides the participant's legs during locomotion over a treadmill with partial body weight support)."
554016|NCT00125593|B3|Baseline|Total|Total of all reporting groups
554017|NCT00125593|B2|Baseline|Placebo|Once daily tablet
554018|NCT00125593|B1|Baseline|Simvastatin Plus Ezetimibe|Once daily tablet
554019|NCT00125593|P2|Participant Flow|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554020|NCT00125593|P1|Participant Flow|Simvastatin 20mg Plus Ezetimibe 10mg|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554021|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554022|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554061|NCT00125268|B3|Baseline|Total|Total of all reporting groups
554023|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554024|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554025|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554026|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554027|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554028|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554029|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554030|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554031|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554032|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554033|NCT00125593|O2|Outcome|Placebo|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets (placebo simvastatin plus ezetimibe tablet with a placebo simvastatin tablet) during the first year. After the first year, all patients took one tablet (placebo simvastatin plus ezetimibe tablet).
554034|NCT00125593|O1|Outcome|Simvastatin Plus Ezetimibe|A double-dummy method ensured that patients and study staff were unaware of the treatment allocation, with all patients taking 2 tablets during the first year (active simvastatin plus ezetimibe tablet with a placebo simvastatin tablet). After the first year, all patients took one tablet (active simvastatin 20mg plus ezetimibe 10mg tablet).
554035|NCT00125593|E2|Reported Event|Placebo|Once daily tablet
554036|NCT00125593|E1|Reported Event|Simvastatin Plus Ezetimibe|Once daily tablet
554037|NCT00125528|B3|Baseline|Total|Total of all reporting groups
554038|NCT00125528|B2|Baseline|Placebo|placebo: placebo bid
554039|NCT00125528|B1|Baseline|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
554040|NCT00125528|P2|Participant Flow|Placebo|placebo: placebo bid
554041|NCT00125528|P1|Participant Flow|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
554042|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
554043|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
554044|NCT00125528|O2|Outcome|Placebo|placebo: placebo bid
554045|NCT00125528|O1|Outcome|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
554046|NCT00125528|E2|Reported Event|Placebo|placebo: placebo bid
554047|NCT00125528|E1|Reported Event|D-cycloserine|D-cycloserine: D-cycloserine 50 mg bid; D-cycloserine 100 mg bid; D-cycloserine 200 mg bid
554048|NCT00125515|B4|Baseline|Total|Total of all reporting groups
554049|NCT00125515|B3|Baseline|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
554050|NCT00125515|B2|Baseline|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
554051|NCT00125515|B1|Baseline|Placebo|Placebo plus oral naltrexone
554052|NCT00125515|P3|Participant Flow|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
554053|NCT00125515|P2|Participant Flow|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
554054|NCT00125515|P1|Participant Flow|Placebo|Placebo plus oral naltrexone
554055|NCT00125515|O3|Outcome|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
554056|NCT00125515|O2|Outcome|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
554057|NCT00125515|O1|Outcome|Placebo|Placebo plus oral naltrexone
554058|NCT00125515|E3|Reported Event|Memantine 15 mg Bid|memantine 15 mg bid plus oral naltrexone
554059|NCT00125515|E2|Reported Event|Memantine 30 mg Bid|Memantine 30 mg bid plus oral naltrexone
554060|NCT00125515|E1|Reported Event|Placebo|Placebo plus oral naltrexone
554062|NCT00125268|B2|Baseline|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554063|NCT00125268|B1|Baseline|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554064|NCT00125268|P2|Participant Flow|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554065|NCT00125268|P1|Participant Flow|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554066|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554067|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554068|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554069|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554070|NCT00125268|O2|Outcome|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554071|NCT00125268|O1|Outcome|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554072|NCT00125268|E2|Reported Event|Sham|Subjects randomized to this arm will receive treatment with the sham device, which is non-active but otherwise identical to the study device.
554073|NCT00125268|E1|Reported Event|MIRE|Subjects randomized to this arm will receive treatment with monochromatic near infrared photo energy (MIRE).
554074|NCT00125242|B3|Baseline|Total|Total of all reporting groups
554075|NCT00125242|B2|Baseline|Non Treatment Stimuli Development Participants|Participants for stimuli development provided normative data for stimuli development. e.g., Treatment items were grouped according to typicality of category membership (apple - typical fruit; coconut - atypical fruit). These participants provided the reponses that served as the basis for classifying/organizing stimuli. Because data from this group were used only for the purposes of stimuli development, no findings are reported for this group. See Cameron, R.M., Wambaugh, J.L., & Mauszycki, S. (2008). Effects of age, gender and education on semantic fluency for living and artifact categories. Aphasiology, 22(7/8), 790-801, doi: 10.1080/02687030701818018 for related findings.
554076|NCT00125242|B1|Baseline|SFA Treatment Participants|Semantic Feature Analysis (SFA) is a word-retrieval treatment for aphasia. SFA entails having the speech-language pathologist (SLP) guide the participant through generation of pertinent semantic features for pictured treatment items (e.g., category membership, physical description, location of item in context, personal associations, associated actions). For some participants, treatment items were grouped by typicality of category membership (e.g, robin-typical bird and penguin-atypical bird). Training of atypical items may stimulate a broader semantic activation of the category and thus, may promote greater generalization. Treatment was applied sequentially to sets of items in single-subject, multiple baseline designs. Thus, replication of treatment effects could be evaluated within and across participants. Treatment was administered by SLPs three times per week until prescribed accuracy levels were met during probes or a maximum number of treatment sessions was completed.
554077|NCT00125242|P2|Participant Flow|SFA Treatment Participants|Stroke survivors who received experimental therapy
554078|NCT00125242|P1|Participant Flow|Non Treatment Stimuli Development Participants|Non-brain-injured participants who were enrolled for the purpose of stimuli development
554079|NCT00125242|O1|Outcome|SFA Treatment Participants|Stroke survivors received Semantic Feature Analysis for the treatment of word-retrieval deficits. Each SFA treatment participant received word-retrieval therapy applied sequentially to experimental lists of items. Effect sizes were calculated for each participant for each list. An average effect size was calculated for each participant and an overall average was determined for all participants as a group.
554080|NCT00125242|E2|Reported Event|NonTreatment Stimuli Development Participants|Non-brain-injured participants who were utilized to develop treatment stimuli.
554081|NCT00125242|E1|Reported Event|SFA Treatment Participants|"Stroke-survivors who received Semantic Feature Analysis therapy for aphasic word-retrieval deficits~Semantic Feature Training: The treatment is designed to stimulate the semantic feature network so that it may serve as not only a mechanism for improving disrupted lexical semantic processing, but also as a compensatory strategy during word retrieval failures."
554082|NCT00125190|B1|Baseline|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554083|NCT00125190|P1|Participant Flow|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554084|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554085|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554086|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554087|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554088|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554089|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554090|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554091|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554092|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554093|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554094|NCT00125190|O1|Outcome|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554095|NCT00125190|E1|Reported Event|rhIGF-1 QD|During the treatment phase, subjects received subcutaneous (SC) injections of rhIGF-1 at an initial dose of 60 µg/kg QD, with subsequent dose adjustments made in order to achieve the target serum IGF-1 concentration for the subject’s age and sex.
554096|NCT00125164|B5|Baseline|Total|Total of all reporting groups
554097|NCT00125164|B4|Baseline|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554098|NCT00125164|B3|Baseline|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554099|NCT00125164|B2|Baseline|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554100|NCT00125164|B1|Baseline|Untreated|Observational Group
554101|NCT00125164|P4|Participant Flow|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554102|NCT00125164|P3|Participant Flow|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554103|NCT00125164|P2|Participant Flow|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554104|NCT00125164|P1|Participant Flow|Untreated|Observational Group
554105|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554106|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554107|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554108|NCT00125164|O1|Outcome|Untreated|Observational Group
554109|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554110|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554111|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554112|NCT00125164|O1|Outcome|Untreated|Observational Group
554113|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554114|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554115|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554116|NCT00125164|O1|Outcome|Untreated|Observational Group
554117|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554118|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554119|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554120|NCT00125164|O1|Outcome|Untreated|Observational Group
554121|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554122|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554123|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554124|NCT00125164|O1|Outcome|Untreated|Observational Group
554125|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554126|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
571629|NCT00064844|E1|Reported Event|Nicotine Patch Plus Active Gum|
554127|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554128|NCT00125164|O1|Outcome|Untreated|Observational Group
554129|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554130|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554131|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554132|NCT00125164|O1|Outcome|Untreated|Observational Group
554133|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554134|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554135|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554136|NCT00125164|O1|Outcome|Untreated|Observational Group
554137|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554138|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554139|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554140|NCT00125164|O1|Outcome|Untreated|Observational Group
554141|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554142|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554143|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554144|NCT00125164|O1|Outcome|Untreated|Observational Group
554145|NCT00125164|O4|Outcome|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554146|NCT00125164|O3|Outcome|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554147|NCT00125164|O2|Outcome|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554148|NCT00125164|O1|Outcome|Untreated|Observational Group
554149|NCT00125164|E4|Reported Event|120 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 120 μg/kg BID
554150|NCT00125164|E3|Reported Event|80 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 80 μg/kg BID
554151|NCT00125164|E2|Reported Event|40 μg/kg BID (Twice Daily Dosing)|Injection of rhIGF-1 40 μg/kg BID. Per protocol amendment these subjects were reassigned to receive 120 μg/kg BID. Due to the dose change, the efficacy results for these subjects were analysed in a separate subanalysis. For all outcome measures, mean and standard deviations were not calculated for this arm.
554152|NCT00125164|E1|Reported Event|Untreated|Observational Group
554153|NCT00125138|B5|Baseline|Total|Total of all reporting groups
554154|NCT00125138|B4|Baseline|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
554155|NCT00125138|B3|Baseline|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
554156|NCT00125138|B2|Baseline|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
554157|NCT00125138|B1|Baseline|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
554158|NCT00125138|P4|Participant Flow|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
554159|NCT00125138|P3|Participant Flow|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
554160|NCT00125138|P2|Participant Flow|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
554161|NCT00125138|P1|Participant Flow|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
554162|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
554163|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
554164|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
554165|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
554166|NCT00125138|O4|Outcome|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
554167|NCT00125138|O3|Outcome|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
554168|NCT00125138|O2|Outcome|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
554169|NCT00125138|O1|Outcome|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
554170|NCT00125138|E4|Reported Event|Placebo|Syrup with 0.3 mg/mL quinine orally QHS
554171|NCT00125138|E3|Reported Event|Melperone HCl - 60 mg|5 mg/mL Melperone syrup orally QHS
554172|NCT00125138|E2|Reported Event|Melperone HCl - 40 mg|5 mg/mL Melperone syrup orally QHS
554173|NCT00125138|E1|Reported Event|Melperone HCl - 20 mg|5 mg/mL Melperone syrup orally QHS
554174|NCT00125034|B3|Baseline|Total|Total of all reporting groups
554217|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554218|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554175|NCT00125034|B2|Baseline|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554176|NCT00125034|B1|Baseline|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554177|NCT00125034|P2|Participant Flow|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554178|NCT00125034|P1|Participant Flow|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554179|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554180|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554181|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554182|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554183|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554184|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554185|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554186|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554187|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554219|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554188|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554189|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554190|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554191|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554192|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554193|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554194|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554195|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554196|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554197|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554198|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554199|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554200|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554201|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554202|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554203|NCT00125034|O2|Outcome|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554204|NCT00125034|O1|Outcome|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554205|NCT00125034|E2|Reported Event|FOLFOX-4 Alone|5-FU/FA and oxaliplatin. Oxaliplatin will always be administered first or simultaneously with FA (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day IV over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554206|NCT00125034|E1|Reported Event|Cetuximab Plus FOLFOX-4|Cetuximab plus 5-Fluorouracil(5-FU)/Folinic acid (FA) and oxaliplatin. Cetuximab will always be administered first, followed by oxaliplatin at least 1 hour later. Following completion of the oxaliplatin infusion or simultaneously with oxaliplatin FA will be administered (at a dose of 200 mg/m^2, infused over 120 minutes, on day 1 and day 2, every two weeks) and then 5-FU (as a bolus of 400 mg/m^2/day intravenously (IV) over 2-4 minutes followed by 600 mg/m^2/day infused over 22-hour, on day 1 and day 2, every two weeks). Until progression or unacceptable toxicity develops. Safety population: includes all treated subjects.
554207|NCT00124982|B3|Baseline|Total|Total of all reporting groups
554208|NCT00124982|B2|Baseline|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554209|NCT00124982|B1|Baseline|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554210|NCT00124982|P3|Participant Flow|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554211|NCT00124982|P2|Participant Flow|ST-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554212|NCT00124982|P1|Participant Flow|Short Term (ST) Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554213|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554214|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554215|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554216|NCT00124982|O1|Outcome|Open-label Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554220|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554221|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554222|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554223|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554224|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554225|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554226|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554227|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554228|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554229|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554230|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554231|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554232|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554233|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554234|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554235|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554236|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554237|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554238|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554239|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554240|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554241|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554242|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554243|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554244|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554245|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554246|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554247|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554248|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554249|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554250|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554251|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554252|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554253|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554254|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554255|NCT00124982|O1|Outcome|Long-term ABA|Participants continued to receive the same 10 mg/kg weight-tiered dose of abatacept that they received in the initial short-term period.
554256|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554257|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554258|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554259|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554260|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554261|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554262|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554263|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554264|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554265|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554266|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554267|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554513|NCT00124449|B2|Baseline|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554268|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554269|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554270|NCT00124982|O1|Outcome|All Treated Participants|Open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554271|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554272|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554273|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554274|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554275|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554276|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554277|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554278|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554279|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554280|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554281|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554282|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
555705|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
554283|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554284|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554285|NCT00124982|O2|Outcome|ST ABA-Current User|In participants currently using Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554286|NCT00124982|O1|Outcome|ST Abatacept (ABA)-Previous User|In participants who had previously used Tumor Necrosis Factor (TNF)-agonists, open-label abatacept was administered on Days 1, 15, and 29 and then once a month thereafter on a background of non-biologic Disease Modifying Anti-Rheumatic Drug (DMARD)s. Participants weighing < 60 kg received 500 mg, participants weighing 60 to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of open-label abatacept by intravenous (IV) infusion.
554287|NCT00124982|E2|Reported Event|Abatacept (ST)|
554288|NCT00124982|E1|Reported Event|Abatacept (LT)|
554289|NCT00124943|B5|Baseline|Total|Total of all reporting groups
554290|NCT00124943|B4|Baseline|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554291|NCT00124943|B3|Baseline|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554292|NCT00124943|B2|Baseline|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554293|NCT00124943|B1|Baseline|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554294|NCT00124943|P4|Participant Flow|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554295|NCT00124943|P3|Participant Flow|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554296|NCT00124943|P2|Participant Flow|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554297|NCT00124943|P1|Participant Flow|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554298|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554299|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554300|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554301|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554302|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554303|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554304|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554514|NCT00124449|B1|Baseline|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554305|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554306|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554307|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554308|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554309|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554310|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554311|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554312|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554313|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554314|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554315|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554316|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554317|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554318|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554319|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554320|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554321|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554322|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554323|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554324|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554325|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554326|NCT00124943|O4|Outcome|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
555706|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
554327|NCT00124943|O3|Outcome|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554328|NCT00124943|O2|Outcome|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554329|NCT00124943|O1|Outcome|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554330|NCT00124943|E4|Reported Event|45 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 45 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554331|NCT00124943|E3|Reported Event|35 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 35 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554332|NCT00124943|E2|Reported Event|22 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 22 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesions) or balloon angioplasty (in-stent restenosis lesions).
554333|NCT00124943|E1|Reported Event|10 mg/m^2 Nanoparticle Paclitaxel|Participants received a single dose of 10 mg/m^2 nanoparticle paclitaxel administered via intracoronary catheter immediately following percutaneous transluminal coronary angioplasty/stenting (de novo lesion) or balloon angioplasty (in-stent restenosis lesions).
554334|NCT00124748|B3|Baseline|Total|Total of all reporting groups
554335|NCT00124748|B2|Baseline|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554336|NCT00124748|B1|Baseline|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554337|NCT00124748|P2|Participant Flow|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554338|NCT00124748|P1|Participant Flow|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554339|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554340|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554341|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554342|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554343|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554344|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554345|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554346|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554347|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554348|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554349|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554350|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554351|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554352|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554353|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554354|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554355|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554356|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554357|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554358|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554359|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554360|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554361|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554362|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554363|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554364|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554365|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554366|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554367|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554368|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554369|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554370|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554371|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554372|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554373|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554515|NCT00124449|P2|Participant Flow|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554374|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554375|NCT00124748|O2|Outcome|Imatinib 800 mg|Patients randomized to receive 800 mg Imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554376|NCT00124748|O1|Outcome|Imatinib 400 mg|Oral dose of 400mg Imatinib once daily (q.d.). All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554377|NCT00124748|E2|Reported Event|Imatinib 800mg|Patients randomized to receive 800 mg imatinib were to receive 400 mg twice daily (b.i.d.) oral administration, in the morning and the evening. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted or reduced based on guidelines defined in protocol.
554378|NCT00124748|E1|Reported Event|Imatinib 400mg|Oral dose of 400mg imatinib once daily. All patients received the assigned dose starting on Day 0 (Visit 3). The dose of Imatinib could be interrupted, reduced, or escalated based on guidelines defined in protocol.
554379|NCT00124735|B11|Baseline|Total|Total of all reporting groups
554380|NCT00124735|B10|Baseline|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554381|NCT00124735|B9|Baseline|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554382|NCT00124735|B8|Baseline|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554383|NCT00124735|B7|Baseline|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554384|NCT00124735|B6|Baseline|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554385|NCT00124735|B5|Baseline|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554386|NCT00124735|B4|Baseline|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554387|NCT00124735|B3|Baseline|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554388|NCT00124735|B2|Baseline|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554389|NCT00124735|B1|Baseline|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554390|NCT00124735|P10|Participant Flow|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554391|NCT00124735|P9|Participant Flow|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554392|NCT00124735|P8|Participant Flow|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554393|NCT00124735|P7|Participant Flow|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554394|NCT00124735|P6|Participant Flow|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554395|NCT00124735|P5|Participant Flow|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554396|NCT00124735|P4|Participant Flow|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554397|NCT00124735|P3|Participant Flow|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554398|NCT00124735|P2|Participant Flow|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554399|NCT00124735|P1|Participant Flow|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554400|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554401|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554402|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554516|NCT00124449|P1|Participant Flow|Abatacept|Abatacept by intravenous (IV) infusion, dose based on participant’s body weight at the screening visit
554403|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554404|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554405|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554406|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554407|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554408|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554409|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554410|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554411|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554412|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554413|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554414|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554415|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554416|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554417|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554418|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554419|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554420|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554421|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554422|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554423|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554424|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554425|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554426|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554427|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554428|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554429|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554430|NCT00124735|O10|Outcome|Rocuronium Continuous Infusion Maintenance - Adolescents (IA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554431|NCT00124735|O9|Outcome|Rocuronium Continuous Infusion Maintenance - Children (IC)|Children subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554432|NCT00124735|O8|Outcome|Rocuronium Continuous Infusion Maintenance - Toddlers (IT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554433|NCT00124735|O7|Outcome|Rocuronium Continuous Infusion Maintenance - Infants (II)|Infant subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554434|NCT00124735|O6|Outcome|Rocuronium Continuous Infusion Maintenance - Neonates (IN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation
554435|NCT00124735|O5|Outcome|Rocuronium Bolus Maintenance - Adolescents (BA)|Adolescent subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554436|NCT00124735|O4|Outcome|Rocuronium Bolus Maintenance -Children (BC)|Children subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554437|NCT00124735|O3|Outcome|Rocuronium Bolus Maintenance - Toddlers (BT)|Toddler subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554438|NCT00124735|O2|Outcome|Rocuronium Bolus Maintenance - Infants (BI)|Infant subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554439|NCT00124735|O1|Outcome|Rocuronium Bolus Maintenance - Neonate (BN)|Neonate subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation
554440|NCT00124735|E2|Reported Event|Rocuronium Continuous Infusion Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by continuous infusion of rocuronium for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents)
554441|NCT00124735|E1|Reported Event|Rocuronium Bolus Maintenance|Subjects that received a bolus dose of rocuronium for intubation followed by bolus doses for maintenance of muscle relaxation (includes neonates, infants, toddlers, children, and adolescents).
554442|NCT00124709|B3|Baseline|Total|Total of all reporting groups
554443|NCT00124709|B2|Baseline|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554444|NCT00124709|B1|Baseline|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554445|NCT00124709|P2|Participant Flow|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554446|NCT00124709|P1|Participant Flow|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554447|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554448|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554449|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554450|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554451|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554452|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554453|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554454|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554455|NCT00124709|O2|Outcome|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554456|NCT00124709|O1|Outcome|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554457|NCT00124709|E2|Reported Event|Control Treatment Group|Management with vehicle/topical corticosteroid rescue.
554458|NCT00124709|E1|Reported Event|Pimecrolimus (Elidel) Treatment Group|Pimecrolimus (Elidel) 1% Cream twice a day/topical corticosteroid rescue
554459|NCT00124657|B4|Baseline|Total|Total of all reporting groups
554460|NCT00124657|B3|Baseline|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
554461|NCT00124657|B2|Baseline|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
554462|NCT00124657|B1|Baseline|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
554463|NCT00124657|P3|Participant Flow|Phase II Only|39 participants were enrolled on the Phase II portion of the trial only.
554464|NCT00124657|P2|Participant Flow|Phase I and Phase II|5 patients participated in both the Phase I portion and the Phase II portion of the study.
554465|NCT00124657|P1|Participant Flow|Phase I Only|18 participants were enrolled on the Phase I portion of the trial only.
554466|NCT00124657|O2|Outcome|Grade 4 Toxicity|Grade 4 toxicity per CTCAE 3.0.
554467|NCT00124657|O1|Outcome|Grade 3 Toxicity|Grade 3 toxicity per CTCAE 3.0.
554468|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
554469|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) are not eligible for this study. Patients with spinal cord tumors will be eligible for the Phase I and Phase II component of this study, but they will not be taken into consideration to estimate PFS in the Phase II component of this trial because of their notoriously worse prognosis. Patients receive erlotinib hydrochloride.~Erlotinib hydrochloride: This study had 2 components: a Phase I component which estimated the MTD and DLT(s) of erlotinib given once a day during and after conventionally fractionated RT for a period of 8 weeks (DLT-evaluation period), followed by continuous administration of this medication for up to 3 years; and a Phase II component where erlotinib was given at the MTD during and after RT for 2 years."
554511|NCT00124579|E1|Reported Event|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554470|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
554471|NCT00124657|O1|Outcome|Patients With High-Grade/Low-Grade Glioma|"Participants included patients with newly diagnosed high-grade glioma (excluding those originating in the brain stem) and unfavorable low-grade glioma who are ≥ 3 years and <26 years of age. Patients receiving enzyme-inducing anticonvulsants (EIACs) were not eligible for this study.~Patients received erlotinib hydrochloride: In the Phase II component of this study, erlotinib was given at the MTD during and after RT for 2 years. The recommended dose of erlotinib for the Phase II component of the current study was 120mg/m^2 per day (maximum dose of 200mg per day)."
554472|NCT00124657|O4|Outcome|Phase II GBM|Participants with a diagnosis of intracranial glioblastoma multiforme (GBM) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
554473|NCT00124657|O3|Outcome|Phase II AA|Participants with a diagnosis of intracranial anaplastic astrocytoma (AA) treated with a combination of maximum safe surgical resection, local RT, and erlotinib.
554474|NCT00124657|O2|Outcome|Phase I GBM|All participants with a diagnosis of glioblastoma multiforme (GBM) and treated on Phase I.
554475|NCT00124657|O1|Outcome|Phase I AA|All participants with a diagnosis of anaplastic astrocytoma (AA) and treated on Phase I.
554476|NCT00124657|O1|Outcome|Phase I|22 participants were analyzed for MLT over 4 dose levels.
554477|NCT00124657|O1|Outcome|Phase I|Phase I participants
554478|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
554479|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
554480|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
554481|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
554482|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
554483|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
554484|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
554485|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
554486|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
554487|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
554488|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
554489|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
554490|NCT00124657|O4|Outcome|160 mg/m^2|Dose level 4 was 160 mg/m^2, range of actual dosage was 151.5-167 mg/m^2.
554491|NCT00124657|O3|Outcome|120 mg/m^2|Dose level 3 was 120 mg/m^2, range of actual dosage was 107-128 mg/m^2.
554492|NCT00124657|O2|Outcome|90 mg/m^2|Dose level 2 was 90 mg/m^2, range of actual dosage was 85-87.5 mg/m^2.
554493|NCT00124657|O1|Outcome|70 mg/m^2|Dose level 1 was 70 mg/m^2, range of actual dosage was 68-83 mg/m^2.
554494|NCT00124657|E5|Reported Event|Phase II|Phase II participants received 120 mg/m^2.
554495|NCT00124657|E4|Reported Event|160 mg/m^2 (Phase I)|Participants received dose of 160 mg/m^2, range of actual dose was 151.5-167 mg/m^2.
554496|NCT00124657|E3|Reported Event|120 mg/m^2 (Phase I)|Participants received dose of 120 mg/m^2, range of actual dose was 107-128 mg/m^2.
554497|NCT00124657|E2|Reported Event|90 mg/m^2 (Phase I)|Participants received dose of 90 mg/m^2, range of actual dose was 85-87.5 mg/m^2.
554498|NCT00124657|E1|Reported Event|70 mg/m^2 (Phase I)|Participants received dose of 70 mg/m^2, range of actual dose was 68-83 mg/m^2.
554499|NCT00124618|B1|Baseline|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554500|NCT00124618|P1|Participant Flow|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554501|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554502|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554503|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554504|NCT00124618|O1|Outcome|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554505|NCT00124618|E1|Reported Event|Cetuximab/Radiation|Cetuximab (C225) and Radiation therapy
554506|NCT00124579|B1|Baseline|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554507|NCT00124579|P1|Participant Flow|Bortezomib With Thalidomide and Dexamethasone Induction|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554508|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554509|NCT00124579|O1|Outcome|Bortezomib With Thalidomide and Dexamethasone|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554510|NCT00124579|O1|Outcome|Bortezomib + Thal/Dex|"Induction (per 21-day cycle): Bortezomib - 1.0 mg/m2 (Days 1, 4, 8, and 11). Dexamethasone - 20 mg/d PO (Days 1, 2, 4, 5, 8, 9, 11, and 12). Thalidomide 100 mg (Days 1-21).~Maintenance (per 28-day cycle): thalidomide 100mg (Days 1-28). Dexamethasone 40 mg Days 1-4."
554517|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554518|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554519|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554520|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554521|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554522|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554523|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554524|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554525|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554526|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554527|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
554528|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554529|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
554530|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554531|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554532|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554533|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554534|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554535|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554536|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554537|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554538|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554539|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
554540|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554541|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554542|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554543|NCT00124449|O1|Outcome|Abatacept|Abatacept by IV infusion, dose based on participant’s body weight at the screening visit
554544|NCT00124449|O2|Outcome|Placebo|Placebo (dextrose 5% in water [D5W] or normal saline [NS]) by IV infusion.
554545|NCT00124449|O1|Outcome|Abatacept|Abatacept by intravenous (IV) infusion, dose based on subject’s body weight at the screening visit
554546|NCT00124449|E2|Reported Event|Placebo|
554547|NCT00124449|E1|Reported Event|BMS-188667|
554548|NCT00124176|B3|Baseline|Total|Total of all reporting groups
554549|NCT00124176|B2|Baseline|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554550|NCT00124176|B1|Baseline|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554551|NCT00124176|P2|Participant Flow|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554552|NCT00124176|P1|Participant Flow|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554553|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554554|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554555|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554556|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554557|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554558|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554559|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554560|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554561|NCT00124176|O2|Outcome|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554562|NCT00124176|O1|Outcome|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554563|NCT00124176|E2|Reported Event|Continuous Racemic (R+S) Albuterol|Continuous racemic albuterol 20mg/hr given as continuous nebulization
554564|NCT00124176|E1|Reported Event|Continuous Levalbuterol (R) Nebulized Solution|Continuous levalbuterol nebulized solution 10mg/hr given as continuous nebulization
554565|NCT00124072|B5|Baseline|Total|Total of all reporting groups
554566|NCT00124072|B4|Baseline|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
554567|NCT00124072|B3|Baseline|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
554568|NCT00124072|B2|Baseline|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
554569|NCT00124072|B1|Baseline|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
554570|NCT00124072|P4|Participant Flow|Simvastatin 80 mg + Placebo|Participants received 80 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
554571|NCT00124072|P3|Participant Flow|Simvastatin 20 mg + Placebo|Participants received 20 mg simvastatin once daily, and placebo folic acid with placebo vitamin B12 once daily
554572|NCT00124072|P2|Participant Flow|Simvastatin 80 mg + Folic Acid and B12|Participants received 80 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
554573|NCT00124072|P1|Participant Flow|Simvastatin 20 mg + Folic Acid and B12|Participants received 20 mg simvastatin once daily, and 2 mg folic acid with 1 mg vitamin B12 once daily
554574|NCT00124072|O4|Outcome|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
554575|NCT00124072|O3|Outcome|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
554576|NCT00124072|O2|Outcome|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
554577|NCT00124072|O1|Outcome|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
554578|NCT00124072|E4|Reported Event|Placebo|Placebo vitamin B12/folic acid tablet once daily in the following arms: simvastatin 20 mg daily + placebo vitamin B12/folic acid; simvastatin 80 mg daily + placebo vitamin B12/folic acid
554579|NCT00124072|E3|Reported Event|Folic Acid 2 mg + Vitamin B12 1 mg Daily|Folic acid 2 mg + vitamin B12 1 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active)
554580|NCT00124072|E2|Reported Event|Simvastatin 80 mg Daily|Simvastatin 80 mg tablet once daily in the following arms: simvastatin 80 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 80 mg daily + placebo vitamin B12/folic acid
554581|NCT00124072|E1|Reported Event|Simvastatin 20 mg Daily|Simvastatin 20 mg tablet once daily in the following arms: simvastatin 20 mg daily + folic acid 2 mg and vitamin B12 1 mg daily (active); simvastatin 20 mg daily + placebo vitamin B12/folic acid
554582|NCT00124020|B3|Baseline|Total|Total of all reporting groups
554583|NCT00124020|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
554584|NCT00124020|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
554585|NCT00124020|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
554586|NCT00124020|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
554587|NCT00124020|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
554588|NCT00124020|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
554589|NCT00124020|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV every 12 hrs.
554590|NCT00124020|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs
554591|NCT00123955|B3|Baseline|Total|Total of all reporting groups
554592|NCT00123955|B2|Baseline|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
554593|NCT00123955|B1|Baseline|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
554594|NCT00123955|P2|Participant Flow|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
554595|NCT00123955|P1|Participant Flow|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
554596|NCT00123955|O2|Outcome|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
554597|NCT00123955|O1|Outcome|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
554598|NCT00123955|E2|Reported Event|Placebo|"Placebo~Placebo: Placebo tablet daily for 9 months"
554599|NCT00123955|E1|Reported Event|Spironolactone|"Spironolactone~Spironolactone: 25mg tablet daily for 9 months"
554600|NCT00123734|B1|Baseline|Group 1|
554601|NCT00123734|P1|Participant Flow|Group 1|
554602|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554603|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554604|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554605|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554606|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554607|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554608|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554609|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554610|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554611|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554612|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554613|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554614|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554615|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554616|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554617|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554618|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554619|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554620|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554621|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554622|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554623|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554624|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554625|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554626|NCT00123734|O4|Outcome|15 Minute and 3 Hour Image Set|Review of whole leg 15 minute and 3 hour images in combination
554627|NCT00123734|O3|Outcome|15 Min and 1 Hour Image Set|Review of whole leg 15 minute and 1 hour images in combination
554628|NCT00123734|O2|Outcome|3 Hour Image Set|Review of 3 hour whole leg images
554629|NCT00123734|O1|Outcome|1 Hour Image Set|Review of whole leg 1 hour images
554630|NCT00123734|E1|Reported Event|Group 1|
554631|NCT00123682|B5|Baseline|Total|Total of all reporting groups
554632|NCT00123682|B4|Baseline|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
554633|NCT00123682|B3|Baseline|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
554634|NCT00123682|B2|Baseline|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
554635|NCT00123682|B1|Baseline|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
554636|NCT00123682|P4|Participant Flow|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
554637|NCT00123682|P3|Participant Flow|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
554638|NCT00123682|P2|Participant Flow|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
554639|NCT00123682|P1|Participant Flow|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
554640|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
554641|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
554642|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
554643|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
554644|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|Reactive referral and self-help materials
554645|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|Proactive referral and self-help materials
554646|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|Reactive referral and intensive counseling
554647|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|Proactive referral and intensive telephone counseling
554648|NCT00123682|O4|Outcome|Reactive Referral and Self-help Materials|
554649|NCT00123682|O3|Outcome|Proactive Referral and Self-help Materials|
554650|NCT00123682|O2|Outcome|Reactive Referral and Intensive Counseling|
554651|NCT00123682|O1|Outcome|Proactive Referral and Intensive Telephone Counseling|
554652|NCT00123682|E4|Reported Event|Reactive Referral and Self-help Materials|
554653|NCT00123682|E3|Reported Event|Proactive Referral and Self-help Materials|
554654|NCT00123682|E2|Reported Event|Reactive Referral and Intensive Counseling|
554655|NCT00123682|E1|Reported Event|Proactive Referral and Intensive Telephone Counseling|
554656|NCT00123643|B3|Baseline|Total|Total of all reporting groups
554657|NCT00123643|B2|Baseline|Glyburide|
554658|NCT00123643|B1|Baseline|Rosiglitazone|
554659|NCT00123643|P2|Participant Flow|Glyburide|
554660|NCT00123643|P1|Participant Flow|Rosiglitazone|
554661|NCT00123643|O2|Outcome|Glyburide|
554662|NCT00123643|O1|Outcome|Rosiglitazone|
554663|NCT00123643|E2|Reported Event|Glyburide|
554664|NCT00123643|E1|Reported Event|Rosiglitazone|
554665|NCT00123630|B3|Baseline|Total|Total of all reporting groups
554666|NCT00123630|B2|Baseline|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554667|NCT00123630|B1|Baseline|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554668|NCT00123630|P2|Participant Flow|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554669|NCT00123630|P1|Participant Flow|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554702|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554670|NCT00123630|O2|Outcome|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554671|NCT00123630|O1|Outcome|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554672|NCT00123630|E2|Reported Event|Omalizumab|Xolair (Omalizumab)150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554673|NCT00123630|E1|Reported Event|Placebo|Placebo 150 to 375 mg is administered SC every 2 or 4 weeks. Because the solution is slightly viscous, the injection may take 5-10 seconds to administer. Doses (mg) and dosing frequency are determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg).
554674|NCT00123604|B3|Baseline|Total|Total of all reporting groups
554675|NCT00123604|B2|Baseline|Carvedilol|Carvedilol, orally, 25mg, twice daily for five months
554676|NCT00123604|B1|Baseline|Metoprolol|Metoprolol, orally, 200mg, twice daily for five months
554677|NCT00123604|P2|Participant Flow|Carvedilol|Carvedilol, orally, 25 mg, once daily
554678|NCT00123604|P1|Participant Flow|Metoprolol|Metoprolol, orally, 200 mg, once daily
554679|NCT00123604|O2|Outcome|Metoprolol|Metoprolol, orally, 200mg, once daily
554680|NCT00123604|O1|Outcome|Carvedilol|Carvedilol, orally, 25mg, once daily
554681|NCT00123604|E2|Reported Event|Carvedilol|Carvedilol, orally, 25 mg, once daily
554682|NCT00123604|E1|Reported Event|Metoprolol|Metoprolol, orally, 200mg, once daily
554683|NCT00123487|B3|Baseline|Total|Total of all reporting groups
554684|NCT00123487|B2|Baseline|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554685|NCT00123487|B1|Baseline|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554686|NCT00123487|P2|Participant Flow|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554687|NCT00123487|P1|Participant Flow|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554688|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554689|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554690|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554691|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554692|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554693|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554694|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554695|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554696|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554697|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554698|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554699|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554700|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554701|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554703|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554704|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554705|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554706|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554707|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554708|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554709|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554710|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554711|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554712|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554713|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554714|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554715|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554716|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554717|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554718|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554719|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554720|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554721|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554722|NCT00123487|O2|Outcome|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant..
554723|NCT00123487|O1|Outcome|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554724|NCT00123487|E2|Reported Event|Dasatinib 70 mg BID|Dasatinib was administered orally at a dose of 70 mg twice a day (BID) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554725|NCT00123487|E1|Reported Event|Dasatinib 140 mg QD|Dasatinib was administered orally at a dose of 140 mg once a day (QD) until disease progression, drug toxicity, withdrawal of consent, investigator or sponsor decision, pregnancy, or decision to do stem cell transplant.
554726|NCT00123474|B5|Baseline|Total|Total of all reporting groups
554727|NCT00123474|B4|Baseline|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554728|NCT00123474|B3|Baseline|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554729|NCT00123474|B2|Baseline|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
571630|NCT00064792|B3|Baseline|Total|Total of all reporting groups
554730|NCT00123474|B1|Baseline|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554731|NCT00123474|P4|Participant Flow|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554732|NCT00123474|P3|Participant Flow|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554733|NCT00123474|P2|Participant Flow|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554734|NCT00123474|P1|Participant Flow|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554735|NCT00123474|O3|Outcome|Total|Participants received study drug in any schedule or total daily dose until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554736|NCT00123474|O2|Outcome|Other Treatment Groups|Participants participated in all other treatment arms until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw.
554737|NCT00123474|O1|Outcome|100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554738|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554739|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554740|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554741|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554742|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554743|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554744|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554745|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554746|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554747|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554748|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554749|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554750|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554751|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554752|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554753|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554754|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
571826|NCT00063635|O3|Outcome|Placebo|Matching placebo
554755|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554756|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554757|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554758|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554759|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554760|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554761|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554762|NCT00123474|O4|Outcome|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554763|NCT00123474|O3|Outcome|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554764|NCT00123474|O2|Outcome|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554765|NCT00123474|O1|Outcome|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554766|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554767|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554768|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554769|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554770|NCT00123474|O4|Outcome|Total Daily Dose 140 mg|Participants received either 140 mg QD or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554771|NCT00123474|O3|Outcome|Total Daily Dose 100 mg|Participants received either 100 mg QD or 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554772|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554773|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554774|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554775|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554776|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554777|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554778|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554779|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554780|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
555707|NCT00121485|E2|Reported Event|HeartMate XVE|Implantation of HeartMate XVE LVAS
554781|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554782|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554783|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554784|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554785|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554786|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554787|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554788|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554789|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554790|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554791|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554792|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554793|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554794|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554795|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554796|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554797|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554798|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554799|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554800|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554801|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554830|NCT00123422|P1|Participant Flow|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
554831|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
554802|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554803|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554804|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554805|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554806|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554807|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg twice a day (BID) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554808|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554809|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg once a day (QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554810|NCT00123474|O4|Outcome|Dasatinib 70 mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554811|NCT00123474|O3|Outcome|Dasatinib 50 mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554812|NCT00123474|O2|Outcome|Dasatinib 140 mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554813|NCT00123474|O1|Outcome|Dasatinib 100 mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554814|NCT00123474|O4|Outcome|Dasatinib 140 mg Total Daily Dose|Participants received 140 mg as a total daily dose (either 70 mg BID or 140 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554815|NCT00123474|O3|Outcome|Dasatinib 100 mg Total Daily Dose|Participants received 100 mg as a total daily dose (either 50 mg BID or 100 mg QD) until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554816|NCT00123474|O2|Outcome|Dasatinib BID|Participants received either 50 mg BID or 70 mg BID until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule.
554817|NCT00123474|O1|Outcome|Dasatinib QD|Participants received either 100 mg QD or 140 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554818|NCT00123474|O2|Outcome|BID Dasatinib|Participants received either 50 mg or 70 mg twice a day (BID) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554819|NCT00123474|O1|Outcome|QD Dasatinib|Participants received either 100 mg or 140 mg once a day (QD) dasatinib until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.
554820|NCT00123474|E4|Reported Event|70mg BID|Participants received 70 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554821|NCT00123474|E3|Reported Event|50mg BID|Participants received 50 mg BID until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554822|NCT00123474|E2|Reported Event|140mg QD|Participants received 140 mg QD until progression of disease, development of intolerable toxicity, or the participant's decision to withdraw. After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing.
554823|NCT00123474|E1|Reported Event|100mg QD|"Participants received 100 mg QD until progression of disease, development of intolerable toxicity, or the participant’s decision to withdraw.~After the 2-year analysis, and with Protocol Amendment 02, participants on a BID dosing schedule were allowed to switch to a QD dosing schedule."
554824|NCT00123422|B4|Baseline|Total|Total of all reporting groups
554825|NCT00123422|B3|Baseline|Exercise|"Exercise training~Exercise: exercise training"
554826|NCT00123422|B2|Baseline|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
554827|NCT00123422|B1|Baseline|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
554828|NCT00123422|P3|Participant Flow|Exercise|"Exercise training~Exercise: exercise training"
554829|NCT00123422|P2|Participant Flow|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
554832|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
554833|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
554834|NCT00123422|O3|Outcome|Exercise|"Exercise training~Exercise: exercise training"
554835|NCT00123422|O2|Outcome|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
554836|NCT00123422|O1|Outcome|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
554837|NCT00123422|E3|Reported Event|Exercise|"Exercise training~Exercise: exercise training"
554838|NCT00123422|E2|Reported Event|Heliox|"Exercise training with helium oxygen combination~Heliox: exercise training with a helium oxygen combination"
554839|NCT00123422|E1|Reported Event|Breathing Retraining|"Exercise training with computerized training program~Breathing retraining: exercise training with computerized training program"
554840|NCT00123409|B3|Baseline|Total|Total of all reporting groups
554841|NCT00123409|B2|Baseline|Usual Care|"Usual Care~Usual Care: Usual care"
554842|NCT00123409|B1|Baseline|Telephone Disease Management|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
554843|NCT00123409|P2|Participant Flow|Arm 2|"Usual Care~Usual Care: Usual care"
554844|NCT00123409|P1|Participant Flow|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
554845|NCT00123409|O2|Outcome|Arm 2|"Usual Care~Usual Care: Usual care"
554846|NCT00123409|O1|Outcome|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
554847|NCT00123409|O2|Outcome|Usual Care|"Usual Care~Usual Care: Usual care"
554848|NCT00123409|O1|Outcome|Telephone Based Management|"Telephone Based Management used to reduce alcohol misuse~Telephone disease management: Telephone based care management"
554849|NCT00123409|E2|Reported Event|Arm 2|"Usual Care~Usual Care: Usual care"
554850|NCT00123409|E1|Reported Event|Arm 1|"Telephone Based care management for reducing alcohol use~Telephone disease management: Telephone based care management"
554851|NCT00123162|B3|Baseline|Total|Total of all reporting groups
554852|NCT00123162|B2|Baseline|Placebo|A single vaginal dose of placebo.
554853|NCT00123162|B1|Baseline|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
554854|NCT00123162|P2|Participant Flow|Placebo|A single vaginal dose of placebo.
554855|NCT00123162|P1|Participant Flow|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
554856|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
554857|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
554858|NCT00123162|O2|Outcome|Placebo|A single vaginal dose of placebo.
554859|NCT00123162|O1|Outcome|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
554860|NCT00123162|E2|Reported Event|Placebo|A single vaginal dose of placebo.
554861|NCT00123162|E1|Reported Event|Sildenafil Citrate|A single vaginal dose of sildenafil citrate 100 mg.
554862|NCT00123123|B4|Baseline|Total|Total of all reporting groups
554863|NCT00123123|B3|Baseline|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
554864|NCT00123123|B2|Baseline|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
554865|NCT00123123|B1|Baseline|Placebo|Vehicle control twice a day (oral rinse)
554866|NCT00123123|P3|Participant Flow|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
554867|NCT00123123|P2|Participant Flow|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
554868|NCT00123123|P1|Participant Flow|Placebo|Vehicle control twice a day (oral rinse)
554869|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
554870|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
554871|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
554872|NCT00123123|O3|Outcome|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
554873|NCT00123123|O2|Outcome|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
554874|NCT00123123|O1|Outcome|Placebo|Vehicle control twice a day (oral rinse)
554875|NCT00123123|E3|Reported Event|Chlorhexidine|chlorhexidine 1 oz oral rinse twice a day
554876|NCT00123123|E2|Reported Event|Chlorhexidine/Placebo|Chlorhexidine oral rinse 1 oz once a day/placebo oral rinse once a day
554877|NCT00123123|E1|Reported Event|Placebo|Vehicle control twice a day (oral rinse)
554878|NCT00122980|B3|Baseline|Total|Total of all reporting groups
554879|NCT00122980|B2|Baseline|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
554880|NCT00122980|B1|Baseline|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
554881|NCT00122980|P2|Participant Flow|Transfusion/Chelation|2: The Transfusion/Chelation group includes participants randomized to Standard Treatment. Participants continued to receive monthly blood transfusions designed to maintain ≤30% HbS, with local discretion regarding type of transfusion (e.g., simple or erythrocytapheresis). These participants also received daily iron chelation typically with deferasirox (Exjade®). Children already on chelation initially maintained their current dose, while those starting deferasirox received 20 mg/kg/day, with dose escalation in both groups as indicated and tolerated.
554882|NCT00122980|P1|Participant Flow|Hydroxyurea/Phlebotomy|1: The Hydroxyurea/Phlebotomy group includes participants randomized to Alternative Treatment. Participants commenced hydroxyurea treatment at 20 mg/kg/day with step-wise escalation to maximum tolerated dose (MTD) defined by mild myelosuppression (absolute neutrophil count 2-4 x 10^9/L). Transfusions continued for 4-9 months during an overlap phase using a modified schedule to protect against recurrent stroke during hydroxyurea dose escalation. Once MTD was reached and transfusions were discontinued, phlebotomy commenced with a target of 10 mL/kg (maximum volume 500mL) blood removed monthly to reduce iron burden. Lower phlebotomy volumes (5 mL/kg) were recommended if participants were excessively anemic (hemoglobin concentration 7.0-7.9 gm/dL); phlebotomy was not performed if the hemoglobin level was <7.0 gm/dL. The total duration of study treatment was 30 months after randomization, with a final study visit scheduled 6-months after discontinuation of study treatments.
554883|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554884|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554885|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554886|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554887|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554888|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554889|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554890|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554891|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554892|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554893|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554894|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554895|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554896|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554897|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554898|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554899|NCT00122980|O2|Outcome|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554900|NCT00122980|O1|Outcome|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554901|NCT00122980|E2|Reported Event|Transfusion/Chelation|Transfusion and Chelation Group (Standard Treatment Arm)
554902|NCT00122980|E1|Reported Event|Hydroxyurea/Phlebotomy|Hydroxyurea and Phlebotomy Group (Alternative Treatment Arm)
554903|NCT00122954|B1|Baseline|Placebo Versus Omega-3 Fatty Acids|
554904|NCT00122954|P2|Participant Flow|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
554905|NCT00122954|P1|Participant Flow|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
554906|NCT00122954|O2|Outcome|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
554907|NCT00122954|O1|Outcome|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
554908|NCT00122954|E2|Reported Event|Omega-3 Fatty Acids|Participants randomized to the omega-3 FA group received capsules in the form of fish oil concentrate (triglyceride form) at a daily dose of 6 grams (1.95 grams of EPA and 1.45 grams of DHA).
554909|NCT00122954|E1|Reported Event|Placebo|Participants randomized to the placebo group received capsules that contained soybean oil with 1% fish oil so that it was flavored to taste and smell similar to the fish oil capsules.
554910|NCT00122681|B3|Baseline|Total|Total of all reporting groups
554911|NCT00122681|B2|Baseline|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554912|NCT00122681|B1|Baseline|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554913|NCT00122681|P2|Participant Flow|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554914|NCT00122681|P1|Participant Flow|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554915|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554916|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554917|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554918|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554919|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554920|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554921|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554922|NCT00122681|O1|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554923|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554924|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554925|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554926|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554927|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554928|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554929|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554930|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554931|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554932|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554933|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554934|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554935|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554936|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554937|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554938|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554939|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554940|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554941|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554942|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554943|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554944|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554945|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554946|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554947|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554948|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554949|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554950|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554951|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554952|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554953|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554954|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554955|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554956|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554957|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554958|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554959|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554960|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554961|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554962|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554963|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554964|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554965|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554966|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554967|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554968|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554969|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554970|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554971|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554972|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554973|NCT00122681|O2|Outcome|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554974|NCT00122681|O1|Outcome|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554975|NCT00122681|E2|Reported Event|Cervarix Group|Subjects received 3 doses of Cervarix™ (GSK Biologicals' human papillomavirus [HPV] vaccine) at Months 0, 1 and 6.
554976|NCT00122681|E1|Reported Event|Havrix Group|Subjects received 3 doses of GSK Biologicals' hepatitis A vaccine [HAV] (Havrix™-based investigational formulation) at Months 0, 1 and 6.
554977|NCT00122460|B3|Baseline|Total|Total of all reporting groups
554978|NCT00122460|B2|Baseline|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554979|NCT00122460|B1|Baseline|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554980|NCT00122460|P2|Participant Flow|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554981|NCT00122460|P1|Participant Flow|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554982|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554983|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554984|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554985|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554986|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554987|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554988|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554989|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554990|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554991|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554992|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554993|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554994|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554995|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554996|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554997|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554998|NCT00122460|O2|Outcome|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
554999|NCT00122460|O1|Outcome|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
555000|NCT00122460|E2|Reported Event|Chemotherapy Alone|All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
555001|NCT00122460|E1|Reported Event|Cetuximab Plus Chemotherapy|Subjects in will receive initial dose of 400 mg/m^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m^2 on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m^2 continuous IV from day 1 to day 4) every 3 weeks.
555002|NCT00122447|B5|Baseline|Total|Total of all reporting groups
555003|NCT00122447|B4|Baseline|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
555004|NCT00122447|B3|Baseline|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
555005|NCT00122447|B2|Baseline|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
555006|NCT00122447|B1|Baseline|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
555007|NCT00122447|P4|Participant Flow|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
555008|NCT00122447|P3|Participant Flow|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
555009|NCT00122447|P2|Participant Flow|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
555010|NCT00122447|P1|Participant Flow|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
555011|NCT00122447|O3|Outcome|Diabetes|"After 75g OGTT:~Fasting glucose >=126 mg/dl and 2-hr glucose level >=200 mg/dl"
555012|NCT00122447|O2|Outcome|Impaired Glucose Tolerance (IGT)|"After 75g OGTT:~Fasting glucose <126 mg/dl and 2-hr glucose level 140-199 mg/dl"
555013|NCT00122447|O1|Outcome|Normal Glucose Tolerance (NGT)|Normal fasting glucose (<100 mg/dl) and normal 2-hr glucose level (<140 mg/dl) after 75g OGTT
555014|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
555015|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
555016|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
555017|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
555018|NCT00122447|O4|Outcome|Placebo|Aspirin placebo PO once a day Olmesartan placebo PO once a day Alpha lipoic acid placebo PO twice a day
555019|NCT00122447|O3|Outcome|Alpha Lipoic Acid (ALA) 600 mg PO Twice Daily|Antioxidant
555020|NCT00122447|O2|Outcome|Olmesartan (ARB) 40 mg PO Once Daily|Angiotensin receptor blocker (ARB)
555021|NCT00122447|O1|Outcome|Aspirin (ASA) 325 mg PO Once Daily|Anti-inflammatory agent
555022|NCT00122447|E5|Reported Event|Enrolled, But Not Yet Randomized|Enrolled into study, but not yet randomized to study medication
555023|NCT00122447|E4|Reported Event|Placebo|Aspirin placebo once a day Olmesartan placebo once a day Alpha lipoic acid placebo twice a day
555024|NCT00122447|E3|Reported Event|Alpha Lipoic Acid|Antioxidant
555025|NCT00122447|E2|Reported Event|Olmesartan|Angiotensin receptor blocker (ARB)
555026|NCT00122447|E1|Reported Event|Aspirin|Anti-inflammatory agent
555027|NCT00122382|B3|Baseline|Total|Total of all reporting groups
555028|NCT00122382|B2|Baseline|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555029|NCT00122382|B1|Baseline|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555030|NCT00122382|P3|Participant Flow|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with weekly oral MTX were administered every 28 days from Month 12 to Month 24 (open-label period).
555031|NCT00122382|P2|Participant Flow|Placebo (PLA) + Methotrexate (MTX) (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX) titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12 (end of double blind period).
555032|NCT00122382|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12 (end of double blind period).
555033|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555034|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555035|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555036|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555037|NCT00122382|O2|Outcome|Year 2 Change|Year 2 Change = Day 729 (Month 24) - Day 365 (Month 12)
555038|NCT00122382|O1|Outcome|Year 1 Change|Year 1 Change = Day 365 - Day 1
555039|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555040|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555041|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555042|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555043|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555044|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555708|NCT00121485|E1|Reported Event|HeartMate II|Implantation of HeartMate II LVAS
555045|NCT00122382|O1|Outcome|ABA + MTX (Open-label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555046|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555047|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555048|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555049|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555050|NCT00122382|O2|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555051|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555052|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555053|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555054|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555055|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555056|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period). The groups are determined by treatment status in the double blind period to observe efficacy differences.
555057|NCT00122382|O2|Outcome|Anti-CTLA4-T Antibody Response|
555058|NCT00122382|O1|Outcome|Anti-Abatacept Antibody Response|
555059|NCT00122382|O1|Outcome|ABA + MTX (Open Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555060|NCT00122382|O1|Outcome|ABA + MTX (Open-Label)|Participants who received ABA + MTX in the 12-month, open-label period of the study (including 232 subjects who previously received ABA + MTX and 227 subjects who previously received PLA + MTX in the 12-month, double-blind period of the study). ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week was administered every 28 days from Month 12 to Month 24 (open-label period).
555061|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555062|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555063|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555064|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555065|NCT00122382|O2|Outcome|ABA + MTX Post-discontinuation|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555066|NCT00122382|O1|Outcome|ABA+ MTX On-treatment|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555067|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555068|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555069|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555070|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555071|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555072|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555073|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555074|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555075|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555076|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555077|NCT00122382|O2|Outcome|PLA + MTX (Double-Blind)|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555078|NCT00122382|O1|Outcome|ABA + MTX (Double-Blind)|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555079|NCT00122382|E2|Reported Event|Placebo|Placebo (Dextrose 5% Water for Injection U.S.P. [D5W] or Normal Saline [NS] IV infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Administered on Days 1, 15, 29, and every 28 days thereafter up to Month 12.
555080|NCT00122382|E1|Reported Event|Abatacept|ABA 10 mg/kg (weight-tiered dose) intravenous (IV) infusions in combination with oral MTX titrated to at least 15 mg per week not to exceed 20 mg per week. Study drug administered on Days 1, 15, 29 and every 28 days thereafter up to Month 12.
555081|NCT00122369|B4|Baseline|Total|Total of all reporting groups
555082|NCT00122369|B3|Baseline|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
555083|NCT00122369|B2|Baseline|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555084|NCT00122369|B1|Baseline|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555085|NCT00122369|P3|Participant Flow|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
556516|NCT00117949|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
555086|NCT00122369|P2|Participant Flow|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555087|NCT00122369|P1|Participant Flow|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555088|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555089|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555090|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555091|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555092|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555093|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555094|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555095|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555096|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555097|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555098|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555099|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555100|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555101|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555102|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555103|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555104|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555105|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555106|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555107|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555108|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
556760|NCT00117338|O2|Outcome|Placebo|
555109|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555110|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555111|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555112|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555113|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555114|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555115|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555116|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555117|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555118|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555119|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555120|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555121|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555122|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555123|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555124|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555125|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555126|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555127|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555128|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555129|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555130|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555180|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
556761|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
555131|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555132|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555133|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555134|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555135|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555136|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555137|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555138|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555139|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555140|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555141|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555142|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555143|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555144|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555145|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555146|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555147|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555148|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555149|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555150|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555151|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555152|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555153|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
556762|NCT00117338|O2|Outcome|Placebo|
555154|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555155|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555156|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555157|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555158|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555159|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555160|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555161|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555162|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555163|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555164|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555165|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555166|NCT00122369|O3|Outcome|Uncertain Diagnosis|"were in the uncertain diagnostic group, either because their result had not been communicated yet (n=54); their LCBB could not be performed for technical reasons and they were waiting for a surgical excision (n=14); or histology showed at risk lesions (n=4) or benign cells with surgery recommended for excision and final diagnosis (n=1)."
555167|NCT00122369|O2|Outcome|Known Malignant Disease|Women who were diagnosed to have malignant disease
555168|NCT00122369|O1|Outcome|Known Benign Disease|Women who were diagnosed to have benign disease
555169|NCT00122369|O3|Outcome|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient's anxiety, pain, or worries according to the prescriptions of the script.
555170|NCT00122369|O2|Outcome|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555171|NCT00122369|O1|Outcome|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555172|NCT00122369|E3|Reported Event|Self-Hypnotic Relaxation|In the Hypnosis condition, patients received all of the attentive behaviors used in the Empathy condition. In addition, the research assistant read a standardized hypnotic induction script (Lang et al. 1999), and, as needed, addressed the patient’s anxiety, pain, or worries according to the prescriptions of the script.
555173|NCT00122369|E2|Reported Event|Empathic Attention|The Empathy condition was defined by a set of structured attentive behaviors engaged in by a research assistant. These behaviors were standardized according to a manual and proven suitable for invasive procedures in radiology (Lang and Berbaum 1997; Lang et al. 1999)
555174|NCT00122369|E1|Reported Event|Standard of Care|As standard care, the biopsy team attempted to comfort patients in their usual way: they warned of upcoming stimuli, asked patients about their experience, commiserated with them about discomfort, and generally expressed sympathy.
555175|NCT00122187|B3|Baseline|Total|Total of all reporting groups
555176|NCT00122187|B2|Baseline|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555177|NCT00122187|B1|Baseline|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
555178|NCT00122187|P2|Participant Flow|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555179|NCT00122187|P1|Participant Flow|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
555181|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555182|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
555183|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
555184|NCT00122187|O4|Outcome|Usual Care 2nd Site (2b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555185|NCT00122187|O3|Outcome|Usual Care 1st Site (1b)|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555186|NCT00122187|O2|Outcome|Electronic Consult System 2nd Site (2a)|A new consult system designed to automatically send a gastroenterology consult request for patients with FOBT+ results
555187|NCT00122187|O1|Outcome|Electronic Consult System 1st Site (1a)|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
555188|NCT00122187|E2|Reported Event|Usual Care|The usual and customary procedures for addressing FOBT+ results: primary care physicians continued to be responsible for follow up of FOBT+ results.
555189|NCT00122187|E1|Reported Event|Electronic Consult System|A new consult system designed to automatically send a gastroenterology consult request for patients with positive fecal occult blood testing (FOBT+) results
555190|NCT00122135|B3|Baseline|Total|Total of all reporting groups
555191|NCT00122135|B2|Baseline|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
555192|NCT00122135|B1|Baseline|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
555193|NCT00122135|P2|Participant Flow|Patients Without VI|Patients who did not receive the Values Inventory prior to their clinic visit
555194|NCT00122135|P1|Participant Flow|Patients With VI|"patients / surrogates who did receive the Values Inventory prior to their clinic appointment~Values history discussion w/physician & patient/surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
555195|NCT00122135|O2|Outcome|Patients Without VI|Patients who did not receive the Values History prior to their clinic appointment (usual care)
555196|NCT00122135|O1|Outcome|Patients With VI|Patients who filled out the Values History prior to their clinic appointment
555197|NCT00122135|E2|Reported Event|Patients Without VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who did not receive the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
555198|NCT00122135|E1|Reported Event|Patients With VI|"Clinic encounter w/physician & patient and/or surrogate - Patients who completed the VI prior to their physician clinic encounter~Clinic encounter w/physician & patient and/or surrogate: 128 patient/physician values history discussions were taped, also 4 case studies with surrogates were completed."
555199|NCT00122109|B3|Baseline|Total|Total of all reporting groups
555200|NCT00122109|B2|Baseline|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferncing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
555201|NCT00122109|B1|Baseline|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555202|NCT00122109|P2|Participant Flow|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention face-to-face traditional modality as compared to the experimental condition which is the via a videoteleconferencing modality .~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555203|NCT00122109|P1|Participant Flow|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555204|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
555205|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555206|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555207|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555208|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555209|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555210|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via a traditional face to face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a face to face modality."
555211|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555212|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555213|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555214|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555215|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555216|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555217|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555218|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555219|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555220|NCT00122109|O2|Outcome|Face to Face AMT|"The control arm is the group condition that received the CPT treatment intervention via the traditional face to face modality as compared to the control condition which is the experimental videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555221|NCT00122109|O1|Outcome|Videoteleconferencing AMT|"The experimental arm is the group condition that received the CPT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555222|NCT00122109|O2|Outcome|Face to Face AMT|The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.
555223|NCT00122109|O1|Outcome|Videoteleconferencing AMT|The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.
555224|NCT00122109|E2|Reported Event|Face to Face AMT|"The control arm is the group condition that received the AMT treatment intervention via a traditional face-to-face modality as compared to the experimental condition which is the videoteleconferencing modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555225|NCT00122109|E1|Reported Event|Videoteleconferencing AMT|"The experimental arm is the group condition that received the AMT treatment intervention via a videoteleconferencing modality as compared to the control condition which is the traditional face-to-face modality.~Anger Management Therapy (AMT) group treatment intervention: 12-session CBT Anger Management Treatment conducted over a videoteleconferencing modality."
555226|NCT00121836|B1|Baseline|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555227|NCT00121836|P1|Participant Flow|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555228|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555229|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
555230|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555231|NCT00121836|O2|Outcome|First Study Treatment Phase Only|"Capecitabine+Bevacizumab:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle."
555232|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555233|NCT00121836|O1|Outcome|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555234|NCT00121836|E1|Reported Event|Capecitabine+Bevacizumab (Bev); Paclitaxel or Vinorelbine +Bev|"First Study Treatment Phase:~Capecitabine 1000 mg/m² oral (PO) twice-daily, Days 1-15 of each 3-week cycle (28 doses per cycle); bevacizumab 15 mg/kg intravenous (IV) infusion, Day 1 of each 3-week cycle.~Second Study Treatment Phase:~Paclitaxel 80 mg/m² 60-minute IV infusion (with appropriate premedication), Days 1, 8 and 15 of each 4-week cycle (28 days). Substitution of paclitaxel with docetaxel was not allowed.~Vinorelbine 25 mg/m² IV infusion over 10-20 minutes, Days 1, 8, and 15 of each 4-week cycle.~Bevacizumab 10 mg/kg IV infusion, Days 1 and 15 of each 4-week cycle."
555235|NCT00121810|B3|Baseline|Total|Total of all reporting groups
555236|NCT00121810|B2|Baseline|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555237|NCT00121810|B1|Baseline|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555238|NCT00121810|P2|Participant Flow|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555239|NCT00121810|P1|Participant Flow|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555240|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555241|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555242|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555243|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555244|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555245|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555246|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555247|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555248|NCT00121810|O2|Outcome|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555249|NCT00121810|O1|Outcome|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555250|NCT00121810|E2|Reported Event|Mycophenolate Mofetil + Cyclosporine or Tacrolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + cyclosporine or tacrolimus according to the study center protocol
555251|NCT00121810|E1|Reported Event|Mycophenolate Mofetil + Sirolimus|Mycophenolate mofetil orally twice daily at a dose of 1.0 g to 1.5 g + sirolimus orally at a dose of 2 g to 10 g followed by a maintenance dose of 2 mg once daily
555252|NCT00121719|B15|Baseline|Total|Total of all reporting groups
555463|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555464|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555465|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555253|NCT00121719|B14|Baseline|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555254|NCT00121719|B13|Baseline|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555255|NCT00121719|B12|Baseline|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555256|NCT00121719|B11|Baseline|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555257|NCT00121719|B10|Baseline|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555258|NCT00121719|B9|Baseline|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555259|NCT00121719|B8|Baseline|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555260|NCT00121719|B7|Baseline|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555261|NCT00121719|B6|Baseline|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555466|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556763|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
555262|NCT00121719|B5|Baseline|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555263|NCT00121719|B4|Baseline|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555264|NCT00121719|B3|Baseline|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555265|NCT00121719|B2|Baseline|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555266|NCT00121719|B1|Baseline|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555267|NCT00121719|P14|Participant Flow|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555268|NCT00121719|P13|Participant Flow|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555269|NCT00121719|P12|Participant Flow|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555270|NCT00121719|P11|Participant Flow|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555467|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556764|NCT00117338|O2|Outcome|Placebo|
556765|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
555271|NCT00121719|P10|Participant Flow|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555272|NCT00121719|P9|Participant Flow|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555273|NCT00121719|P8|Participant Flow|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555274|NCT00121719|P7|Participant Flow|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555275|NCT00121719|P6|Participant Flow|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555276|NCT00121719|P5|Participant Flow|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555277|NCT00121719|P4|Participant Flow|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555278|NCT00121719|P3|Participant Flow|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555468|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555469|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555470|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555279|NCT00121719|P2|Participant Flow|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555280|NCT00121719|P1|Participant Flow|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555281|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555282|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed State|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555283|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555284|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555285|NCT00121719|O2|Outcome|25 mg Lenvatinib Fasted|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555286|NCT00121719|O1|Outcome|25 mg Lenvatinib Fed|Participants who agreed to participate in the food-effect study received a single oral dose of lenvatinib (25 mg) after a high-fat meal (including potatoes and bacon) or following at least a 10 hour fast on the morning of either Cycle 1 Day 15 or Cycle 1 Day 22 between 8:00 am and 10:00 am. Whichever state (fed or fasted) the participant took the lenvatinib on Day 15, they did the opposite on Day 22. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555287|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555288|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555471|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555472|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556766|NCT00117338|O2|Outcome|Placebo|
555289|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555290|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555291|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555292|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555293|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555294|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555295|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555296|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555473|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555474|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555475|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555297|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555298|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555299|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555300|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555301|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555302|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555303|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555304|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555476|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555477|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555592|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555305|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555306|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555307|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555308|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555309|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555310|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555311|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555312|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555478|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555479|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556767|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
556768|NCT00117338|O2|Outcome|Placebo|
555313|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555314|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555315|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555316|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555317|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555318|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555319|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555320|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555480|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555481|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555482|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555321|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555322|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555323|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555324|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555325|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555326|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555327|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555328|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555483|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555484|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556769|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
555329|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555330|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555331|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555332|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555333|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555334|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555335|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555336|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555485|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555486|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555593|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555337|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555338|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555339|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555340|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555341|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555342|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555343|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555344|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555487|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555488|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555489|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555345|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555346|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555347|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555348|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555349|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555350|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555351|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555352|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555490|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555491|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556770|NCT00117338|E2|Reported Event|Placebo|
555353|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555354|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555355|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555356|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555357|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555358|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555359|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555360|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555492|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555493|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555594|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555361|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555362|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555363|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555364|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555365|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555366|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555367|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555368|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555494|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555495|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555496|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555369|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555370|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555371|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555372|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555373|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555374|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555375|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555376|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555497|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555498|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555595|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555377|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555378|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555379|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555380|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555381|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555382|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555383|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555384|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555499|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555500|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
556771|NCT00117338|E1|Reported Event|Montelukast Intravenous (IV) 5.25 mg|
555385|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555386|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555387|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555388|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555389|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555390|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555391|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555392|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555501|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555502|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555503|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555393|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555394|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555395|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555396|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555397|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555398|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555399|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555400|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555504|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555505|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555596|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555401|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555402|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555403|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555404|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555405|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555406|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555407|NCT00121719|O4|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
555408|NCT00121719|O3|Outcome|25 mg Lenvatinib|Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
555409|NCT00121719|O2|Outcome|12 - 20 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
555410|NCT00121719|O1|Outcome|0.2 - 6.4 mg Lenvatinib|Lenvatinib tablets (at the appropriate dose for a given dose level) were taken orally, once daily on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided).
555411|NCT00121719|O12|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
556772|NCT00117312|B5|Baseline|Total|Total of all reporting groups
555412|NCT00121719|O11|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555413|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555414|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555415|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555416|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555417|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555418|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555419|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555506|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555507|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555693|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
555420|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555421|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555422|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555423|NCT00121719|O14|Outcome|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555424|NCT00121719|O13|Outcome|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555425|NCT00121719|O12|Outcome|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555426|NCT00121719|O11|Outcome|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555427|NCT00121719|O10|Outcome|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555428|NCT00121719|O9|Outcome|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555508|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555509|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555429|NCT00121719|O8|Outcome|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555430|NCT00121719|O7|Outcome|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555431|NCT00121719|O6|Outcome|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555432|NCT00121719|O5|Outcome|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555433|NCT00121719|O4|Outcome|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555434|NCT00121719|O3|Outcome|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555435|NCT00121719|O2|Outcome|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555436|NCT00121719|O1|Outcome|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555510|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555511|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555512|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555437|NCT00121719|O1|Outcome|Lenvatinib|"Participants not in the food-effect pilot study: 25 mg lenvatinib was administered orally once daily on an empty stomach shortly after waking. Participants fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this period. Grapefruit juice was to be avoided during the study.~Participants in the food-effect pilot study: 25 mg lenvatinib was administered as described above except on Days 15 and 22 in Cycle 1. Participants in this pilot study were randomly assigned to receive lenvatinib under a fed state (following a high fat meal) or fasting state (overnight fast greater than or equal to 10 hours) on Day 15, then in the reverse/untried state on Day 22. For both cases, no food was allowed for 4 hour following administration of lenvatinib."
555438|NCT00121719|E14|Reported Event|32 mg Lenvatinib|Three 10 mg lenvatinib tablets and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555439|NCT00121719|E13|Reported Event|25 mg Lenvatinib (MTD Cohort)|Participants in this cohort had the option of participating in the food-effect pilot study. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555440|NCT00121719|E12|Reported Event|25 mg Lenvatinib Fed/Fasted|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fed state with a high fat meal and the Day 22 dose was taken in a fasted state. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555441|NCT00121719|E11|Reported Event|25 mg Lenvatinib Fasted/Fed|Participants from the MTD Cohort who chose to participate in the food-effect pilot study were randomly assigned to this Cohort. Two 10 mg lenvatinib tablets and five 1.0 mg lenvatinib tablets were taken orally, once daily. The Day 15 dose of lenvatinib was taken in a fasted state and the Day 22 dose was taken in a fed state with a high fat meal. All other doses were taken on an empty stomach after waking, followed by fasting for 2 hours with only clear liquids allowed.
555442|NCT00121719|E10|Reported Event|20 mg Lenvatinib|Two 10 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555443|NCT00121719|E9|Reported Event|16 mg Lenvatinib|One 10 mg lenvatinib tablet and six 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555444|NCT00121719|E8|Reported Event|12.5 mg Lenvatinib|One 10 mg lenvatinib tablet, two 1.0 mg lenvatinib tablets, and five 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555445|NCT00121719|E7|Reported Event|12 mg Lenvatinib|One 10 mg lenvatinib tablet and two 1.0 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555513|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555514|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555446|NCT00121719|E6|Reported Event|6.4 mg Lenvatinib|Six 1.0 mg lenvatinib tablets and four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and theMTD was determined. An additional 12 participants were treated at the MTD level.
555447|NCT00121719|E5|Reported Event|3.2 mg Lenvatinib|Three 1.0 mg lenvatinib tablets and two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555448|NCT00121719|E4|Reported Event|1.6 mg Lenvatinib|One 1.0 mg lenvatinib tablet and six 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555449|NCT00121719|E3|Reported Event|0.8 mg Lenvatinib|Eight 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555450|NCT00121719|E2|Reported Event|0.4 mg Lenvatinib|Four 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced DLT during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the MTD was determined. An additional 12 participants were treated at the MTD level.
555451|NCT00121719|E1|Reported Event|0.2 mg Lenvatinib|Two 0.1 mg lenvatinib tablets were taken orally, once daily. Lenvatinib was to be taken on an empty stomach shortly after waking. Participants were fasted for 2 hours following administration of lenvatinib and could drink only clear fluids during this time (grapefruit juice was to be avoided). If 1 of 3 participants experienced dose-limiting toxicity (DLT) during Cycle 1 (4 weeks) an additional 3 participants were to be treated at this dose level. If 5 of the 6 participants in the expanded dose level did not experience DLT during the first 4 weeks of therapy, no additional DLT was observed, the next dose level was opened for enrollment. If more than 1 participant experienced DLT during the first 4 weeks of therapy, dose escalation was stopped and the maximum tolerated dose (MTD) was determined. An additional 12 participants were treated at the MTD level.
555452|NCT00121667|B5|Baseline|Total|Total of all reporting groups
555453|NCT00121667|B4|Baseline|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555454|NCT00121667|B3|Baseline|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555455|NCT00121667|B2|Baseline|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555456|NCT00121667|B1|Baseline|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555457|NCT00121667|P4|Participant Flow|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555458|NCT00121667|P3|Participant Flow|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555459|NCT00121667|P2|Participant Flow|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555460|NCT00121667|P1|Participant Flow|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555461|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555462|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555694|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555515|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555516|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555517|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555518|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555519|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555520|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555521|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555522|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555523|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555524|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555525|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555526|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555527|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555528|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555529|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555530|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555531|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555532|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555533|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555534|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555535|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555536|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555537|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555538|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555539|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555540|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555541|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555542|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555543|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555544|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555545|NCT00121667|O4|Outcome|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555546|NCT00121667|O3|Outcome|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555547|NCT00121667|O2|Outcome|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555548|NCT00121667|O1|Outcome|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555549|NCT00121667|E4|Reported Event|Saxagliptin 5 mg + Metformin|Tablets, Oral, 5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555550|NCT00121667|E3|Reported Event|Saxagliptin 2.5 mg + Metformin|Tablets, Oral, 2.5 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555551|NCT00121667|E2|Reported Event|Saxagliptin 10 mg + Metformin|Tablets, Oral, 10 mg Saxagliptin (plus flexible metformin dose), Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555552|NCT00121667|E1|Reported Event|Placebo+ Metformin|Tablets, Oral, 0 mg, Once daily (24 weeks ST, 42 months LT); Pioglitazone 15-45 mg (as needed for rescue).
555553|NCT00121641|B5|Baseline|Total|Total of all reporting groups
555554|NCT00121641|B4|Baseline|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555555|NCT00121641|B3|Baseline|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555556|NCT00121641|B2|Baseline|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555557|NCT00121641|B1|Baseline|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555558|NCT00121641|P5|Participant Flow|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555559|NCT00121641|P4|Participant Flow|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555560|NCT00121641|P3|Participant Flow|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555561|NCT00121641|P2|Participant Flow|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555562|NCT00121641|P1|Participant Flow|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks short term [ST], 42 months long term [LT]); Metformin 500-2000 mg (as needed for rescue).
555563|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555564|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555565|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555566|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555567|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555568|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555569|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555570|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555571|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555572|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555573|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555574|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555575|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555576|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555577|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555578|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555579|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555580|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555581|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555582|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555583|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555584|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555585|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555586|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555587|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555588|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555589|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555590|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555591|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555695|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE LVAS
555597|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555598|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555599|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555600|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555601|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555602|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555603|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555604|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555605|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555606|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555607|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555608|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555609|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555610|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555611|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555612|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555613|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555614|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555615|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555616|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555617|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555618|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555619|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555620|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555621|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555622|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555623|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555624|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555625|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555626|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555627|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555628|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555629|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555630|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555631|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555632|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555633|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555634|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555635|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555636|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555637|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555638|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555639|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555640|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555696|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555641|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555642|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555643|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555644|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555645|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555646|NCT00121641|O1|Outcome|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555647|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555648|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555649|NCT00121641|O1|Outcome|Open Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555650|NCT00121641|O1|Outcome|Open-Label Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555651|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555652|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555653|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555654|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555655|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555656|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555657|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555658|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555659|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555660|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555661|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555662|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555663|NCT00121641|O4|Outcome|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555664|NCT00121641|O3|Outcome|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555665|NCT00121641|O2|Outcome|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555666|NCT00121641|O1|Outcome|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555667|NCT00121641|E5|Reported Event|Saxagliptin 5 mg|Tablets, Oral, 5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555668|NCT00121641|E4|Reported Event|Saxagliptin 2.5 mg|Tablets, Oral, 2.5 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555669|NCT00121641|E3|Reported Event|Saxagliptin 10 mg|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555670|NCT00121641|E2|Reported Event|Placebo|Tablets, Oral, 0mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue)
555671|NCT00121641|E1|Reported Event|Open-Label Treatment Cohort (Direct Enrollees)|Tablets, Oral, 10 mg, Once daily (24 weeks ST, 42 months LT); Metformin 500-2000 mg (as needed for rescue).
555672|NCT00121485|B3|Baseline|Total|Total of all reporting groups
555673|NCT00121485|B2|Baseline|HeartMate XVE|Implantation of HeartMate XVE LVAS
555674|NCT00121485|B1|Baseline|HeartMate II|Implantation of HeartMate II LVAS
555675|NCT00121485|P2|Participant Flow|HeartMate XVE|Implantation of HeartMate XVE LVAS
555676|NCT00121485|P1|Participant Flow|HeartMate II|Implantation of HeartMate II LVAS
555677|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555678|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555679|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555680|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555681|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555682|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555683|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555684|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555685|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555686|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555687|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555688|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555689|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555690|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555691|NCT00121485|O2|Outcome|HeartMate XVE|Implantation of HeartMate XVE
555692|NCT00121485|O1|Outcome|HeartMate II|Implantation of HeartMate II LVAS
555709|NCT00121472|B1|Baseline|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
555710|NCT00121472|P1|Participant Flow|HeartMate II (HMII)|HeartMate II Left Ventricular Assist System (HMII LVAS) used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP)).
555711|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
555712|NCT00121472|O1|Outcome|HMII Replacement|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555713|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555714|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555715|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555716|NCT00121472|O1|Outcome|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
555717|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation with at least 1-year follow-up (133 Pivotal Study Cohort and 61 US Continued Access Protocol)
555718|NCT00121472|O1|Outcome|HM II|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555719|NCT00121472|E1|Reported Event|HMII|HeartMate II LVAS used as a bridge to cardiac transplantation (133 Pivotal Study Cohort and 61 US Continued Access Protocol (CAP).
555720|NCT00121238|B1|Baseline|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555721|NCT00121238|P1|Participant Flow|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555722|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555723|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555724|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555725|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555726|NCT00121238|O1|Outcome|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
556773|NCT00117312|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
555727|NCT00121238|E1|Reported Event|Drug Treatment (Cilengitide)|"Patients receive cilengitide IV over 1 hour on days 1, 4, 8, 11, 15, 18, 22, and 25. Treatment repeats every 28 days for at least 3 courses in the absence of disease progression or unacceptable toxicity. After 3 courses, patients undergo evaluation. Patients achieving a complete prostate-specific antigen (PSA) response (i.e., PSA < 0.2 ng/mL) receive 2-3 additional courses of therapy. Patients with partial PSA response or stable disease continue treatment indefinitely in the absence of disease progression or unacceptable toxicity. Patients demonstrating disease progression by CT scan, MRI, or bone scan are removed from the study.~cilengitide : Given IV~Experimental drug treatment : Correlative studies"
555728|NCT00121225|B1|Baseline|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
555729|NCT00121225|P1|Participant Flow|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
555730|NCT00121225|O1|Outcome|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
555731|NCT00121225|E1|Reported Event|Arm I|"Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.~vorinostat"
555732|NCT00121199|B1|Baseline|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555733|NCT00121199|P1|Participant Flow|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555734|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555735|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555736|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555737|NCT00121199|O1|Outcome|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555738|NCT00121199|E1|Reported Event|CHOP + Rituximab + Bevacizumab|Treatment with CHOP, rituximab, and bevacizumab will be administered every 21 days for a maximum of 8 cycles (one cycle is defined as a single 21 day course of treatment). Bevacizumab and rituximab will be given before chemotherapy.
555739|NCT00121186|B1|Baseline|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
555740|NCT00121186|P1|Participant Flow|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
555741|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
555742|NCT00121186|O1|Outcome|Nonmyeloablative Allogeneic Stem Cell Transplant|Patients are given fludarabine 30 mg/m^2 on days -6 to -2 and melphalan 70 mg/m^2 on days -3 and -2, then transplanted with donor peripheral blood stem cells or harvested bone marrow stem cells on day 0. Patients are then given post-transplant immunosuppression consisting of tacrolimus 0.06 mg/kg/day on days -3 to 100 and methotrexate 5 mg/m^2 on days 1, 3, and 7.
555743|NCT00121186|E1|Reported Event|Nonmyeloablative Allogeneic Stem Cell Transplant|
555744|NCT00121134|B5|Baseline|Total|Total of all reporting groups
555745|NCT00121134|B4|Baseline|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
555746|NCT00121134|B3|Baseline|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
555747|NCT00121134|B2|Baseline|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
555748|NCT00121134|B1|Baseline|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
555749|NCT00121134|P4|Participant Flow|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
555750|NCT00121134|P3|Participant Flow|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
555751|NCT00121134|P2|Participant Flow|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
555752|NCT00121134|P1|Participant Flow|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
555753|NCT00121134|O4|Outcome|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
555754|NCT00121134|O3|Outcome|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
555755|NCT00121134|O2|Outcome|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
555756|NCT00121134|O1|Outcome|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
555757|NCT00121134|E4|Reported Event|Group D-bevacizumab + Capecitibine (24wks)|capecitabine 2000 mg orally twice per day for 7 days on/7 days off for 24 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year.
555758|NCT00121134|E3|Reported Event|Group C-Bevacizumab + Capcitabine(18 Wks)|capecitabine 2000 mg/m2/day 14 days on/7 days off for 18 weeks, and bevacizumab 15 mg/kg every 3 weeks for 1 year
555759|NCT00121134|E2|Reported Event|Group B-Bevacizumab+Cyclophosphamide+Methotrexate|Bevacizumab 15 mg/kg every 3 weeks for 1 year +Cyclophosphamide 50 mg orally daily for 6 months +methotrexate 2.5mg orally on day 1-2 each week for 6 months.
555760|NCT00121134|E1|Reported Event|Group A- Bevacizumab Alone|Bevacizumab 15 mg/kg every 3 wks for 1 year
555761|NCT00120874|B3|Baseline|Total|Total of all reporting groups
555762|NCT00120874|B2|Baseline|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555763|NCT00120874|B1|Baseline|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555764|NCT00120874|P2|Participant Flow|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555765|NCT00120874|P1|Participant Flow|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555766|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555767|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555768|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555769|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555770|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555771|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555772|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555773|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555774|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555775|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555776|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555777|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555778|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555966|NCT00119262|E1|Reported Event|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
555779|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555780|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555781|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555782|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555783|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555784|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555785|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555786|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555787|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555788|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555789|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555790|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555791|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555792|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555793|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555794|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555795|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555796|NCT00120874|O2|Outcome|Memantine Alone|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555797|NCT00120874|O1|Outcome|Memantine + CIPCM Program|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555798|NCT00120874|E2|Reported Event|Memantine|"Only Memantine~Memantine: Patients receive 10 milligrams of memantine twice daily."
555799|NCT00120874|E1|Reported Event|Individualized Management and Memantine|"Individualized Management including caregiver training and Memantine~Individualized management of AD including caregiver training: Individualized management program: consists of home visits to get the patient exercising, doing enjoyable activities and cognitive stimulation, educational sessions for caregivers on coping with difficult situations and a caregiver support group to help with questions and emotional concerns.~Memantine: Patients receive 10 milligrams of memantine twice daily."
555800|NCT00120627|B3|Baseline|Total|Total of all reporting groups
555967|NCT00119158|B3|Baseline|Total|Total of all reporting groups
555801|NCT00120627|B2|Baseline|Control Arm: Medication & Case Management Alone|"Usual care consisting of medication and case-management.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555802|NCT00120627|B1|Baseline|Treatment Arm: Mantram + Medication & Case Management|"Mantram Repetition Program (MRP) for PTSD delivered in this study as 6-week, 90-minute per week that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management. The MRP includes three strategies for training attention and managing symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools were presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states."
555803|NCT00120627|P2|Participant Flow|Arm 2: Usual Care|"Usual care consisting of medication and case-management.~Usual care consisted of medication and case management: Case management consisted of provider meetings with Veterans at least once per month and monitoring medications, if prescribed."
555804|NCT00120627|P1|Participant Flow|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555805|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555806|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
555807|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555808|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal."
555809|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555810|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"Mantram Repetition Program (MRP) for PTSD was delivered in this study as 6-week, 90-minute per week group that targeted PTSD symptoms. It was offered as an adjunct to usual care consisting of medication and case-management.~The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources."
555811|NCT00120627|O2|Outcome|Arm 2: Usual Care Alone|"Usual care is defined as receiving 6 weeks of medication and case management, as needed by each patient. No group meetings.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555812|NCT00120627|O1|Outcome|Arm 1: Mantram + Usual Care|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555882|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
555813|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555814|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555815|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555816|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555817|NCT00120627|O2|Outcome|Arm 2: Meds & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555818|NCT00120627|O1|Outcome|Arm 1: Mantram + Meds & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555819|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555820|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting.."
555821|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care) Alone|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555822|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555823|NCT00120627|O2|Outcome|Arm 2: Medication & Case Management (Usual Care Alone)|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
555824|NCT00120627|O1|Outcome|Arm 1: Mantram + Medication & Case Management (Usual Care)|"The Mantram Repetition Program teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555825|NCT00120627|E2|Reported Event|Arm 2|"Usual Care defined as receiving medication management and case management, as needed.~Usual care consisting of medication and case management: Case management consists of meeting with Veterans at least once per month and monitoring medications, if prescribed."
571827|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
555826|NCT00120627|E1|Reported Event|Arm 1|"he MRP teaches 3 strategies to train attention and manage symptoms: Mantram Repetition, Slowing Down and One-Pointed Attention. A mantram is a self-selected, sacred word or phrase that is meaningful to the participant. Slowing down refers to setting priorities and doing things carefully so one is not rushed or does not make mistakes. One-pointed attention refers to concentrating on one thing at a time (similar to mindfulness). These three tools are presented to work together synergistically and cumulatively to interrupt negative thoughts and emotional states such as anger, rage, irritability and hyper-arousal. The unique focus on spiritual words is linked to what one might call inner spiritual resources. MRP was delivered in a 6-week (90 minutes/week) group setting."
555827|NCT00120523|B3|Baseline|Total|Total of all reporting groups
555828|NCT00120523|B2|Baseline|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555829|NCT00120523|B1|Baseline|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555830|NCT00120523|P2|Participant Flow|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555831|NCT00120523|P1|Participant Flow|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555832|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555833|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555834|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555835|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555836|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555837|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555838|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555839|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555840|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555841|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555842|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555843|NCT00120523|O1|Outcome|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555844|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555845|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555846|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555847|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
556025|NCT00118898|B1|Baseline|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
555848|NCT00120523|O2|Outcome|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country's label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555849|NCT00120523|O1|Outcome|Pimecrolimus|Pimecrolimus 1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555850|NCT00120523|E2|Reported Event|Topical Corticosteroids|"Low or medium potency (low potency, e.g. Hydrocortisone acetate; or medium potency, e.g.~Fluticasone propionate)TCS supplied locally were to be used according to the country’s label as study medication for patients randomized to TCS group. Topical corticosteroids were to be applied as a thin layer to the affected skin only and rubbed in gently."
555851|NCT00120523|E1|Reported Event|Pimecrolimus|1% cream was supplied in 50 g tubes by the sponsor. Elidel was to be applied as a thin layer to the affected skin b.i.d., and rubbed in gently and completely by the primary caregiver
555852|NCT00120406|B3|Baseline|Total|Total of all reporting groups
555853|NCT00120406|B2|Baseline|PTA (Control)|Percutaneous balloon angioplasty
555854|NCT00120406|B1|Baseline|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
555855|NCT00120406|P2|Participant Flow|PTA (Control)|Percutaneous balloon angioplasty
555856|NCT00120406|P1|Participant Flow|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
555857|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
555858|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
555859|NCT00120406|O2|Outcome|PTA (Control)|Percutaneous balloon angioplasty
555860|NCT00120406|O1|Outcome|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
555861|NCT00120406|E2|Reported Event|PTA (Control)|Percutaneous balloon angioplasty
555862|NCT00120406|E1|Reported Event|Zilver PTX|Zilver® PTX™ Drug Eluting Vascular Stent
555863|NCT00120289|B3|Baseline|Total|Total of all reporting groups
555864|NCT00120289|B2|Baseline|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555865|NCT00120289|B1|Baseline|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555866|NCT00120289|P2|Participant Flow|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555867|NCT00120289|P1|Participant Flow|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555868|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555869|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555870|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555871|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555872|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555873|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555874|NCT00120289|O2|Outcome|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555875|NCT00120289|O1|Outcome|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555876|NCT00120289|E2|Reported Event|Placebo + Simvastatin|"Simvastatin alone~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555877|NCT00120289|E1|Reported Event|ERN + Simvastatin|"Extended release niacin plus simvastatin~Extended release niacin: 2,000 mg/day or 1,500 mg/day if higher dose not tolerated~Simvastatin: Dose adjusted to achieve LDL-C 40 mg/dL - 80 mg/dL, adding ezetimibe (10 mg/day) if needed to achieve LDL-C target"
555878|NCT00120250|B1|Baseline|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555879|NCT00120250|P2|Participant Flow|Placebo, Then Eszopiclone|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
555880|NCT00120250|P1|Participant Flow|Eszopiclone, Then Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of placebo, followed by another 1 week washout.
555881|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of 3mg eszopiclone, followed by another 1 week washout.
556028|NCT00118898|P2|Participant Flow|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
555883|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555884|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555885|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555886|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555887|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555888|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555889|NCT00120250|O2|Outcome|Placebo|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555890|NCT00120250|O1|Outcome|Eszopiclone|The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555891|NCT00120250|E1|Reported Event|Drug vs Placebo|Eszopiclone : The total study duration is 8 weeks, with subjects receiving 3mg eszopiclone or placebo nightly for 3 weeks, followed by a 1 week washout period, followed by 3 weeks of the alternate condition, followed by another 1 week washout.
555892|NCT00120042|B4|Baseline|Total|Total of all reporting groups
555893|NCT00120042|B3|Baseline|3|Oral misoprostol to assist in placental delivery
555894|NCT00120042|B2|Baseline|2|Intramuscular oxytocin injection
555895|NCT00120042|B1|Baseline|1|No specific oxytocic to assist in placental delivery
555896|NCT00120042|P3|Participant Flow|3|Oral misoprostol to assist in placental delivery
555897|NCT00120042|P2|Participant Flow|2|Intramuscular oxytocin injection
555898|NCT00120042|P1|Participant Flow|1|No specific oxytocic to assist in placental delivery
555899|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
555900|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
555901|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
555902|NCT00120042|O3|Outcome|3|Oral misoprostol to assist in placental delivery
555903|NCT00120042|O2|Outcome|2|Intramuscular oxytocin injection
555904|NCT00120042|O1|Outcome|1|No specific oxytocic to assist in placental delivery
555905|NCT00119678|B3|Baseline|Total|Total of all reporting groups
555906|NCT00119678|B2|Baseline|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555907|NCT00119678|B1|Baseline|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555908|NCT00119678|P2|Participant Flow|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555922|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555923|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555909|NCT00119678|P1|Participant Flow|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555910|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555911|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555912|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg). Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. BILAG A: presence of one or more serious features of lupus; BILAG B: more moderate features of the disease; BILAG C: mild symptomatic features; BILAG D: prior activity with no current symptoms due to active lupus; BILAG E: an organ that has never been involved."
555913|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555914|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555915|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555916|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555917|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555918|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555919|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555920|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555921|NCT00119678|O1|Outcome|Abatacept|Participants were administered with abatacept (10mg/kg) iv infusion over approximately 30 minutes on Days 365, 393, 421 and every 28 days thereafter up to and including Day 729. All participants received a dose based on their screening visit weight (participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg and participants weighing > 100 kg received 1000mg).
555965|NCT00119262|E2|Reported Event|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555924|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555925|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555926|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555927|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555928|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555929|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555930|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555931|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
556029|NCT00118898|P1|Participant Flow|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
555932|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555933|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555934|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555935|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555936|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555937|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555938|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555939|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
556072|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
555940|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555941|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555942|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555943|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555944|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555945|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555946|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555947|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
556073|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
555948|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555949|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555950|NCT00119678|O2|Outcome|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555951|NCT00119678|O1|Outcome|Abatacept|"Participants were administered intravenous (iv) infusions of abatacept (10 mg/kg) over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555952|NCT00119678|E2|Reported Event|Placebo|Participants were administered iv infusions of either dextrose 5% solution or normal saline (NS) at a constant rate over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg OD. A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant’s clinical features qualified for BILAG “C” or “D” status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued.
555953|NCT00119678|E1|Reported Event|Abatacept|"Participants were administered abatacept (10 mg/kg) IV over approximately 30 minutes on Days 1, 15, 29 and every 28 days thereafter up to and including Day 337. All participants received a dose based on screening visit weight. Prednisone or prednisone equivalent was administered at an initial oral dose of 30 mg once daily (OD). A standardized prednisone or prednisone equivalent taper procedure was followed whenever the participant's clinical features qualified for British Isles Lupus Assessment Group (BILAG) C or D status after Day 29. Participants who completed the double-blind period were eligible for the open-label long-term extension period, where all participants were reallocated to abatacept (regardless of randomized treatment in the double-blind period) according to body weight at study entry. Infusions continued every 28 days until abatacept was marketed for SLE or the drug development program discontinued."
555954|NCT00119262|B3|Baseline|Total|Total of all reporting groups
555955|NCT00119262|B2|Baseline|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555956|NCT00119262|B1|Baseline|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
555957|NCT00119262|P2|Participant Flow|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555958|NCT00119262|P1|Participant Flow|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
555959|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555960|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
555961|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555962|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
555963|NCT00119262|O2|Outcome|Arm B (ddAC > BT > B)|Dose dense doxorubicin and cyclophosphamide, followed by paclitaxel and bevacizumab, followed by bevacizumab
555964|NCT00119262|O1|Outcome|Arm A (ddBAC > BT > B)|Dose dense bevacizumab, cyclophosphamide and doxorubicin, followed by paclitaxel and bevacizumab, followed by bevacizumab
556774|NCT00117312|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
555968|NCT00119158|B2|Baseline|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555969|NCT00119158|B1|Baseline|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555970|NCT00119158|P2|Participant Flow|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555971|NCT00119158|P1|Participant Flow|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555972|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555973|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555974|NCT00119158|O2|Outcome|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555975|NCT00119158|O1|Outcome|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555976|NCT00119158|E2|Reported Event|Placebo Arm|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555977|NCT00119158|E1|Reported Event|Active Therapy|Patients had equivalent eczema on each side of the body. One side of the body was treated with 1% pimecrolimus cream twice a day and fluticasone cream once a day. The opposite side of the body was treated with placebo cream twice a day and fluticasone cream once a day
555978|NCT00119041|B4|Baseline|Total|Total of all reporting groups
555979|NCT00119041|B3|Baseline|Provider Interview|Qualitative interviews with providers
555980|NCT00119041|B2|Baseline|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
555981|NCT00119041|B1|Baseline|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park.~We did not collect gender and age related data."
555982|NCT00119041|P3|Participant Flow|Provider Interview|Qualitative interviews with providers
555983|NCT00119041|P2|Participant Flow|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
555984|NCT00119041|P1|Participant Flow|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
555985|NCT00119041|O2|Outcome|Control|non intervention group
555986|NCT00119041|O1|Outcome|Telemedicine|Intervention group
555987|NCT00119041|O2|Outcome|Control CBOC|Received the questionnaires by mail and had no intervention of diabetes teleconference
555988|NCT00119041|O1|Outcome|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
555989|NCT00119041|E3|Reported Event|Provider Interviews|Qualitative interviews with providers.
555990|NCT00119041|E2|Reported Event|Control CBOC|The CBOC's not involved in the intervention phase had their patients not be involved in the telemedicine visit, but traditional education.
556026|NCT00118898|P4|Participant Flow|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556027|NCT00118898|P3|Participant Flow|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556775|NCT00117312|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
555991|NCT00119041|E1|Reported Event|Telemedicine CBOC|"Designated CBOC's were involved in the intervention phase where their DM patients were asked to participate in a telemedicine visit.~The Behavioral: The Diabetes Treatment Satisfaction Questionnaire given during this phase along with the Behavioral: Diabetes Empowerment Scale and the Behavioral: CBOC's undergo half-day joint-clinics via teleconference.~The Diabetes Treatment Satisfaction Questionnaire: A six question likert scale questionnaire regarding the patients treatment satisfaction. The responses range from very dissatisfied to very satisfied.~Diabetes Empowerment Scale: A twenty-eight question likert scale questionnaire regarding the patients attitude towards diabetes. The responses range from strongly agree to strongly disagree.~CBOC's undergo half-day joint-clinics via teleconference: A patient has Diabetes/Endo clinic visit via teleconferencing. A patient is at a CBOC and the Diabetes/Endo physician is at Wade Park."
555992|NCT00119015|B3|Baseline|Total|Total of all reporting groups
555993|NCT00119015|B2|Baseline|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
555994|NCT00119015|B1|Baseline|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
555995|NCT00119015|P3|Participant Flow|Fluticasone Propionate+Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Placebo - 10 mg po daily"
555996|NCT00119015|P2|Participant Flow|Fluticasone Propionate+Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)~Montelukast - 10 mg po daily"
555997|NCT00119015|P1|Participant Flow|Fluticasone Propionate Only|Fluticasone propionate nasal spray - 2 sprays in each nostril once a day (200 micrograms daily)
555998|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
555999|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556000|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
556001|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556002|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
556003|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556004|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
556005|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556006|NCT00119015|O2|Outcome|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
556007|NCT00119015|O1|Outcome|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556008|NCT00119015|E2|Reported Event|Fluticasone Propionate + Placebo|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Placebo - 10 mg po daily for 2 weeks"
556009|NCT00119015|E1|Reported Event|Fluticasone Propionate + Montelukast|"Fluticasone propionate nasal spray - 2 sprays in each nostril once a day for 2 weeks (200 micrograms daily)~Montelukast - 10 mg po daily for 2 weeks"
556010|NCT00118911|B3|Baseline|Total|Total of all reporting groups
556011|NCT00118911|B2|Baseline|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
556012|NCT00118911|B1|Baseline|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
556013|NCT00118911|P2|Participant Flow|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
556014|NCT00118911|P1|Participant Flow|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
556015|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
556016|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
556017|NCT00118911|O2|Outcome|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
556018|NCT00118911|O1|Outcome|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
556019|NCT00118911|E2|Reported Event|Relaxation With Educational Support (RES)|Participants received 12 sessions of individual therapy using our unpublished treatment manual for relaxation plus educational support.
556020|NCT00118911|E1|Reported Event|Cognitive-Behavioral Therapy (CBT)|Participants received 12 sessions of individual cognitive behavioral therapy following our protocol.
556021|NCT00118898|B5|Baseline|Total|Total of all reporting groups
556022|NCT00118898|B4|Baseline|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556023|NCT00118898|B3|Baseline|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556024|NCT00118898|B2|Baseline|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556030|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556031|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556032|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556033|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556034|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556035|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556036|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556037|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556038|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556039|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556040|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556041|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556042|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556043|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556044|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556045|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556046|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556047|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556048|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556049|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556050|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556051|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556052|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556053|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556054|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556055|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556056|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556057|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556058|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556059|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556060|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556061|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556062|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556063|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556064|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556065|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556066|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556067|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556068|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556069|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556070|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556071|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556074|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556075|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556076|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556077|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556078|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556079|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556080|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556081|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556082|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556083|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556084|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556085|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556086|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556087|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556088|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556089|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556090|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556091|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556092|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556093|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556094|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556095|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556096|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556097|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556098|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556099|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556100|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556101|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556102|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556103|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556104|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556105|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556106|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556107|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556108|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556109|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556110|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556111|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556112|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556113|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556114|NCT00118898|O4|Outcome|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556115|NCT00118898|O3|Outcome|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556116|NCT00118898|O2|Outcome|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556117|NCT00118898|O1|Outcome|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556118|NCT00118898|E4|Reported Event|RTV-boosted ATV, Placebo FTC/TDF, and ABC/3TC|Participants will receive RTV-boosted ATV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556119|NCT00118898|E3|Reported Event|RTV-boosted ATV, FTC/TDF, and Placebo ABC/3TC|Participants will receive RTV-boosted ATV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556120|NCT00118898|E2|Reported Event|EFV, Placebo FTC/TDF, and ABC/3TC|Participants will receive EFV, placebo for FTC/TDF, and ABC/3TC for at least 96 weeks
556121|NCT00118898|E1|Reported Event|EFV, FTC/TDF, and Placebo ABC/3TC|Participants will receive EFV, FTC/TDF, and placebo for ABC/3TC for at least 96 weeks
556122|NCT00118755|B3|Baseline|Total|Total of all reporting groups
556123|NCT00118755|B2|Baseline|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556124|NCT00118755|B1|Baseline|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556125|NCT00118755|P2|Participant Flow|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556126|NCT00118755|P1|Participant Flow|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556127|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556128|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556129|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556130|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556131|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556132|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556133|NCT00118755|O2|Outcome|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556134|NCT00118755|O1|Outcome|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556135|NCT00118755|E2|Reported Event|XELOX Q2W + Bevacizumab|"Capecitabine 1500 mg/m^2 twice-daily was given orally. Bevacizumab 5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every two weeks prior to administration of oxaliplatin.~Oxaliplatin 85 mg/m^2 via 2-hour IV infusion was administered on day 1 every 2 weeks."
556136|NCT00118755|E1|Reported Event|XELOX Q3W + Bevacizumab|"Capecitabine 850 mg/m^2 twice-daily was given orally. Bevacizumab 7.5 mg/kg via 30-90 minute intravenous (IV) infusion was administered on day 1 every three weeks prior to administration of oxaliplatin.~Oxaliplatin 130 mg/m^2 via 2-hour IV infusion was administered on day 1 every 3 weeks."
556137|NCT00118742|B3|Baseline|Total|Total of all reporting groups
556138|NCT00118742|B2|Baseline|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556139|NCT00118742|B1|Baseline|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556140|NCT00118742|P2|Participant Flow|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556141|NCT00118742|P1|Participant Flow|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556142|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556143|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556144|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556145|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556146|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556147|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556148|NCT00118742|O2|Outcome|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556149|NCT00118742|O1|Outcome|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556150|NCT00118742|E2|Reported Event|CellCept + Sirolimus|CellCept 1-1.5 g orally or intravenously twice daily, plus sirolimus 2-4 mg orally once daily for 9-11 months
556151|NCT00118742|E1|Reported Event|CellCept + CNI (Tacrolimus or Cyclosporine)|CellCept 1-1.5 g orally or intravenously twice daily, plus a calcineurin inhibitor (CNI) tacrolimus or cyclosporine for 12 months
556152|NCT00118534|B3|Baseline|Total|Total of all reporting groups
556153|NCT00118534|B2|Baseline|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556154|NCT00118534|B1|Baseline|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556155|NCT00118534|P2|Participant Flow|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556156|NCT00118534|P1|Participant Flow|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556157|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556158|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556159|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556160|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556161|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556162|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556163|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556164|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556165|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556166|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556167|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556168|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556169|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556170|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556171|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556172|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556173|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556174|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556175|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556176|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556177|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556178|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556179|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556180|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556181|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556182|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556183|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556184|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556185|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556186|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556187|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556188|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556189|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556190|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556191|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556192|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556776|NCT00117312|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556193|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556194|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556195|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556196|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556197|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556198|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556199|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556200|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556201|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556202|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556203|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556204|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556205|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556206|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556207|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556208|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556209|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556210|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556211|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556212|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556213|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556214|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556215|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556216|NCT00118534|O1|Outcome|Integrated Care|Integration of Smoking Cessation therapy with PTSD therapy.
556217|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556218|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556219|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556220|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556221|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556222|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556223|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556224|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556225|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556226|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556227|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556228|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556229|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556230|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556231|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556232|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556233|NCT00118534|O2|Outcome|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556234|NCT00118534|O1|Outcome|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556235|NCT00118534|E2|Reported Event|Standard of Care|Per standard of care, patients are referred to a smoking cessation clinic for their smoking cessation therapy.
556236|NCT00118534|E1|Reported Event|Integrated Care|Integration of smoking cessation therapy with PTSD therapy.
556237|NCT00118417|B1|Baseline|All Participants|
556238|NCT00118417|P2|Participant Flow|Sertraline / + Placebo / Cognitive Behavior Therapy Augment.|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive their SSRI plus a placebo; In Phase 3, this group will receive their SSRI plus cognitive behavioral therapy (CBT)
556239|NCT00118417|P1|Participant Flow|Sertraline / Increased Dose / Medication Optimization|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI); In Phase 2, this group will receive an increased dosage of their SSRI; In Phase 3, this group will receive medication optimization, which includes an SSRI and clonazepam
556240|NCT00118417|O2|Outcome|Augmented Cognitive Behavior Therapy|This group will receive sertraline or escitalopram with cognitive behavioral therapy (CBT)
556241|NCT00118417|O1|Outcome|Medication Optimization|This group will receive medication optimization, which includes sertraline or escitalopram with clonazepam
556242|NCT00118417|O2|Outcome|Sertraline Plus Placebo|This group will receive sertraline or escitalopram with a placebo
556243|NCT00118417|O1|Outcome|Increased Sertraline|This group will receive an increased dosage of sertraline or escitalopram
556244|NCT00118417|O1|Outcome|Moderate Sertraline Treatment|This group will receive moderate sertraline or escitalopram treatment
556245|NCT00118417|E3|Reported Event|Phase III: Cont. Medication Plus CBT OR SSRI and Clonazepam|
556246|NCT00118417|E2|Reported Event|Phase II: Cont. SSRI Plus Placebo OR Increased Dose SSRI Alone|
556247|NCT00118417|E1|Reported Event|Phase I: Sertraline|In Phase 1, this group will receive a moderate dose of sertraline (or escitalopram, an equivalent SSRI).
556248|NCT00118404|B4|Baseline|Total|Total of all reporting groups
556249|NCT00118404|B3|Baseline|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556250|NCT00118404|B2|Baseline|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556251|NCT00118404|B1|Baseline|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556252|NCT00118404|P3|Participant Flow|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556253|NCT00118404|P2|Participant Flow|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556254|NCT00118404|P1|Participant Flow|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556255|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556256|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556257|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556258|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556259|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556260|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556261|NCT00118404|O3|Outcome|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556262|NCT00118404|O2|Outcome|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556263|NCT00118404|O1|Outcome|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556264|NCT00118404|E3|Reported Event|Continuation Phase Pill Placebo|"Participants received acute phase cognitive therapy and continuation phase fluoxetine~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase fluoxetine : The dosage of fluoxetine was increased to 40 mg over 8 months."
556363|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
571828|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
556265|NCT00118404|E2|Reported Event|Continuation Phase Cognitive Therapy|"Participants received acute phase and continuation phase cognitive therapy~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase cognitive therapy : Continuation phase cognitive therapy included 10 sessions over 8 months."
556266|NCT00118404|E1|Reported Event|Continuation Phase Fluoxetine|"Participants received acute phase cognitive therapy and continuation phase pill placebo~Acute phase cognitive therapy : For the first 12 weeks, all participants received between 16 and 20 cognitive therapy sessions.~Continuation phase pill placebo : The dosage of pill placebo was increased to 40 mg over 8 months."
556267|NCT00118378|B3|Baseline|Total|Total of all reporting groups
556268|NCT00118378|B2|Baseline|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
556269|NCT00118378|B1|Baseline|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
556270|NCT00118378|P2|Participant Flow|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
556271|NCT00118378|P1|Participant Flow|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
556272|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
556273|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
556274|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks.
556275|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks.
556276|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
556277|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
556278|NCT00118378|O2|Outcome|Placebo|Participants randomized to placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
556279|NCT00118378|O1|Outcome|Modafinil|Participants randomized to modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
556280|NCT00118378|E2|Reported Event|Placebo|Participants will take placebo for 4 weeks, if not responsive, a 12-week course of modafinil will be offered.
556281|NCT00118378|E1|Reported Event|Modafinil|Participants will take modafinil for 4 weeks. If responsive, participants will be offered 8 additional weeks of modafinil.
556282|NCT00118365|B3|Baseline|Total|Total of all reporting groups
556283|NCT00118365|B2|Baseline|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556284|NCT00118365|B1|Baseline|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556285|NCT00118365|P2|Participant Flow|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556286|NCT00118365|P1|Participant Flow|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556287|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556288|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556289|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556290|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556291|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556292|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556293|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556294|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556295|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556296|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556297|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556298|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556299|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556300|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556301|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556302|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556303|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556304|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556305|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556306|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556307|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556308|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556309|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556310|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556311|NCT00118365|O4|Outcome|Placebo - AA/GA|"Patients with AA or GA genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556312|NCT00118365|O3|Outcome|Placebo - GG|"Patients with GG genotype receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556313|NCT00118365|O2|Outcome|DFMO + Sulindac - AA/GA|"Patients with AA or GA genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556314|NCT00118365|O1|Outcome|DFMO + Sulindac - GG|"Patients with GG genotype receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556315|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
556316|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
556317|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
556318|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
556319|NCT00118365|O2|Outcome|ODC1 GG|Patients with GG genotype
556320|NCT00118365|O1|Outcome|ODC1 AA/GA|Patients with AA or GA genotype
556321|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556322|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556323|NCT00118365|O4|Outcome|Placebo + Spd:Spm Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
556324|NCT00118365|O3|Outcome|Placebo + Spd:Spm Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~SpSpd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
556325|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Spd:Spm Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm nonresponder = spermidine-to-spermine ratio at 36-month increased, or decreased by < 30% from baseline"
556326|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Spd:Spm Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Spd:Spm Responder = spermidine-to-spermine ratio at 36-month are decreased by >=30% from baseline"
556327|NCT00118365|O4|Outcome|Placebo + Putrescine Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
556328|NCT00118365|O3|Outcome|Placebo + Putrescine Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
556329|NCT00118365|O2|Outcome|Eflornithine and Sulindac + Putrescine Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine nonresponder = Putrescine values at 36-month are increased, or decreased by < 30% from baseline"
556330|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Putrescine Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~Putrescine responder = Putrescine values at 36-month are decreased by >=30% from baseline"
556331|NCT00118365|O4|Outcome|Placebo + PGE2 Nonresponders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
556332|NCT00118365|O3|Outcome|Placebo + PGE2 Responders|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
556333|NCT00118365|O2|Outcome|Eflornithine and Sulindac + PGE2 Nonresponders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 nonresponder = PGE2 values at 36-month are increased, or decreased by < 30% from baseline"
556334|NCT00118365|O1|Outcome|Eflornithine and Sulindac + PGE2 Responders|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~PGE2 Responder = PGE2 values at 36-month are decreased by >=30% in PGE2 values from baseline"
556335|NCT00118365|O4|Outcome|Placebo + High Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above median"
556336|NCT00118365|O3|Outcome|Placebo + Low Spd:Spm at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below median"
556337|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is above the median"
556338|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Spd:Spm at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline spermidine-to-spermine ratio is below the median"
556460|NCT00117988|E1|Reported Event|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
556339|NCT00118365|O4|Outcome|Placebo + High Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is above median"
556340|NCT00118365|O3|Outcome|Placebo + Low Putrescine at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine value is below median"
556341|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is above the median"
556342|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low Putrescine at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline Putrescine values is below the median"
556343|NCT00118365|O4|Outcome|Placebo + High PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is above median"
556344|NCT00118365|O3|Outcome|Placebo + Low PGE2 at Baseline|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 value is below median"
556345|NCT00118365|O2|Outcome|Eflornithine and Sulindac + High PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is above the median"
556346|NCT00118365|O1|Outcome|Eflornithine and Sulindac + Low PGE2 at Baseline|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. The treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies~baseline PGE2 values is below the median"
556347|NCT00118365|O2|Outcome|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556348|NCT00118365|O1|Outcome|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556349|NCT00118365|E2|Reported Event|Arm II (Placebo)|"Patients receive oral double placebo once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~placebo: Given orally~laboratory biomarker analysis: Correlative studies"
556350|NCT00118365|E1|Reported Event|Arm I (Eflornithine and Sulindac)|"Patients receive oral eflornithine (DFMO) and oral sulindac once daily. In both arms, treatment continues for 36 months in the absence of unacceptable toxicity or the development of an invasive malignancy.~eflornithine: Given orally~sulindac: Given orally~laboratory biomarker analysis: Correlative studies"
556351|NCT00118248|B3|Baseline|Total|Total of all reporting groups
556352|NCT00118248|B2|Baseline|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556353|NCT00118248|B1|Baseline|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556354|NCT00118248|P2|Participant Flow|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556355|NCT00118248|P1|Participant Flow|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556356|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556357|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556358|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556359|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556360|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556361|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556362|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556461|NCT00117962|B3|Baseline|Total|Total of all reporting groups
556364|NCT00118248|O2|Outcome|Differentiated Thyroid Carcinoma|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556365|NCT00118248|O1|Outcome|Advanced Medullary Thyroid Carcinoma Group|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556366|NCT00118248|E1|Reported Event|All Patients|Patients receive 220 mg/m^2 tanespimycin IV over 2-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
556367|NCT00118157|B1|Baseline|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
556368|NCT00118157|P1|Participant Flow|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
556369|NCT00118157|O1|Outcome|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
556370|NCT00118157|E1|Reported Event|Arm 1|"Patients receive oral lapatinib and oral tamoxifen once daily on days 1-28.~lapatinib ditosylate: Given orally~tamoxifen citrate: Given orally"
556371|NCT00118144|B1|Baseline|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
556372|NCT00118144|P1|Participant Flow|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
556373|NCT00118144|O1|Outcome|Arm I|"Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.~bortezomib: Given IV"
556374|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
556375|NCT00118144|O1|Outcome|Arm 1|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
556376|NCT00118144|E1|Reported Event|Arm I|Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle.
556377|NCT00118131|B1|Baseline|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556378|NCT00118131|P1|Participant Flow|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556379|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556380|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556381|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556382|NCT00118131|O1|Outcome|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556383|NCT00118131|E1|Reported Event|Docetaxel and Cisplatin|"A cycle is defined as an interval of 28 days.~Docetaxel, 35 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 105 mg/m2).~Cisplatin, 25 mg/m2 per day on Days 1, 8 and 15 (total dose for this cycle = 75 mg/m2).~Docetaxel is always to be given prior to cisplatin on Days 1, 8 and 15."
556384|NCT00118053|B1|Baseline|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556385|NCT00118053|P1|Participant Flow|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556386|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556387|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556388|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556389|NCT00118053|O1|Outcome|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556390|NCT00118053|E1|Reported Event|Docetaxel, Carboplatin and Trastuzumab|"A total of six cycles of TCH [(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged.~Those determined to have localized and operable disease will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks.~If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks."
556391|NCT00118040|B4|Baseline|Total|Total of all reporting groups
556392|NCT00118040|B3|Baseline|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556393|NCT00118040|B2|Baseline|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556394|NCT00118040|B1|Baseline|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556395|NCT00118040|P3|Participant Flow|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556396|NCT00118040|P2|Participant Flow|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556397|NCT00118040|P1|Participant Flow|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556398|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556399|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556400|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556401|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556402|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556403|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556404|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556405|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556512|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556406|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556407|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556408|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556409|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556410|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556411|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556412|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556413|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556414|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556415|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556416|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556417|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556418|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556419|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556420|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556421|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556422|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556423|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556424|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556425|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556426|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556427|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556428|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556429|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556430|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556431|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556432|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556433|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556513|NCT00117949|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556514|NCT00117949|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556434|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556435|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556436|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556437|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556438|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556439|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556440|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556441|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556442|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556443|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556444|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556445|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556446|NCT00118040|O4|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556447|NCT00118040|O3|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556448|NCT00118040|O2|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556449|NCT00118040|O1|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556450|NCT00118040|O4|Outcome|Arm IV (300mg Genistein + 600mg Genistein)|This is a combination analysis those on 300mg of genistein and 600mg genistein
556451|NCT00118040|O3|Outcome|Arm III (Placebo)|Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556452|NCT00118040|O2|Outcome|Arm II (600mg Genistein)|Patients receive oral genistein as in arm I but at a higher dose (600mg). One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556453|NCT00118040|O1|Outcome|Arm I (300mg Genistein)|Patients receive oral genistein (150mg) twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.
556454|NCT00118040|E3|Reported Event|Arm III (Placebo)|"Patients receive oral placebo twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~laboratory biomarker analysis: Correlative studies~placebo: Given orally~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
556455|NCT00118040|E2|Reported Event|Arm II (Higher Dose Genistein)|"Patients receive oral genistein as in arm I but at a higher dose. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
556456|NCT00118040|E1|Reported Event|Arm I (Lower Dose Genistein)|"Patients receive oral genistein twice daily for approximately 14-30 days. One day after completion of genistein or placebo, all patients undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~genistein: Given orally~laboratory biomarker analysis: Correlative studies~therapeutic conventional surgery: Undergo cystoscopic excision, transurethral resection of the bladder tumor, or cystectomy.~pharmacological study: Correlative studies"
556457|NCT00117988|B1|Baseline|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
556458|NCT00117988|P1|Participant Flow|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
556459|NCT00117988|O1|Outcome|17-AAG|17-N-allylamino-17-demethoxygeldanamycin (17-AAG) 220 mg/m^2 intravenous (IV) over 1 hour on days 1, 4, 8, and 11, repeated every 21 days
556515|NCT00117949|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556462|NCT00117962|B2|Baseline|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556463|NCT00117962|B1|Baseline|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556464|NCT00117962|P2|Participant Flow|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556465|NCT00117962|P1|Participant Flow|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556466|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556467|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556468|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556469|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556470|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556471|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556472|NCT00117962|O2|Outcome|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556473|NCT00117962|O1|Outcome|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556474|NCT00117962|E2|Reported Event|Std Tx + Pemetrexed and Cetuximab|Patients receive pemetrexed disodium, carboplatin, and thoracic radiotherapy as in arm I. Patients also receive cetuximab IV over 2 hours on day 1 and then IV over 1 hour on days 8, 15, 22, 29, 36, and 43.
556475|NCT00117962|E1|Reported Event|Std Tx + Pemetrexed|Patients receive pemetrexed disodium IV over 10 minutes followed by carboplatin IV over 30 minutes on days 1, 22, 43, and 64. Patients also undergo thoracic radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, and 43-47.
556476|NCT00117949|B5|Baseline|Total|Total of all reporting groups
556477|NCT00117949|B4|Baseline|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556478|NCT00117949|B3|Baseline|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556479|NCT00117949|B2|Baseline|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556480|NCT00117949|B1|Baseline|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556481|NCT00117949|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556482|NCT00117949|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556483|NCT00117949|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556484|NCT00117949|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556485|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556486|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556487|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556488|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556489|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556490|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556491|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556492|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556493|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556494|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556495|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556496|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556497|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556498|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556499|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556500|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556501|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556502|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556503|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556504|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556505|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556506|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556507|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556508|NCT00117949|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556509|NCT00117949|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556510|NCT00117949|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556511|NCT00117949|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556517|NCT00117845|B1|Baseline|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
556518|NCT00117845|P1|Participant Flow|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
556519|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
556520|NCT00117845|O1|Outcome|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
556521|NCT00117845|E1|Reported Event|Denileukin Diftitox in ATL|Denileukin Diftitox in adult T-cell leukemia (ATL) Patients will be treated with Denileukin Diftitox 9 mcg/kg/d intravenously for 5 days every 2 weeks.
556522|NCT00117806|B3|Baseline|Total|Total of all reporting groups
556523|NCT00117806|B2|Baseline|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556524|NCT00117806|B1|Baseline|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
556525|NCT00117806|P2|Participant Flow|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556526|NCT00117806|P1|Participant Flow|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
556527|NCT00117806|O2|Outcome|Arm 2|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556528|NCT00117806|O1|Outcome|Arm 1|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
556529|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556530|NCT00117806|O1|Outcome|Supported Employment|"SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury~Evidence-Based Supported Employment Vocational Rehabilitation: SCI-VIP: evidence-based supported employment implemented for veterans with spinal cord injury."
556531|NCT00117806|O2|Outcome|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556532|NCT00117806|O1|Outcome|Supported Employment|Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury.
556533|NCT00117806|E2|Reported Event|Treatment As Usual|Standard Care: varies slightly between participating VA SCI centers, however, usually involves referral outside SCI center
556534|NCT00117806|E1|Reported Event|Supported Employment|"SCI-VIP: supported employment implemented for veterans with spinal cord injury~Supported Employment Vocational Rehabilitation: SCI-VIP: supported employment implemented for veterans with spinal cord injury."
556535|NCT00117793|B1|Baseline|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
556536|NCT00117793|P1|Participant Flow|Entire Study Population|"This is a randomized cross-over study. Each participant wore both study prostheses: (1) a total surface bearing socket with a vacuum-assisted suspension system (VASS) and (2) a modified patellar tendon bearing socket with a pin lock suspension system (PIN).~Subjects were randomized, provided with one of two study prostheses, and asked to wear it for three weeks. Data was then collected during laboratory visit one, and, following one more week of wearing the first study prosthesis, during laboratory visit two. Participants were then provided with the second study intervention and asked to wear it for three weeks. Data was then collected during laboratory visit three, and, following one more week of wearing the second study intervention, during laboratory visit four.~Data was not collected on the order in which participants received each study intervention"
556537|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556538|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556539|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556540|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556541|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556542|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556543|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556544|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556545|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556546|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556547|NCT00117793|O2|Outcome|VASS Suspension|A total surface bearing socket with a vacuum-assisted suspension system (VASS).
556548|NCT00117793|O1|Outcome|PIN Suspension|A modified patellar tendon bearing socket with a pin lock suspension system (PIN)
556549|NCT00117793|E1|Reported Event|Entire Study Population|Includes participants randomized to receive PIN first and VASS first.
556550|NCT00117676|B3|Baseline|Total|Total of all reporting groups
556551|NCT00117676|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556777|NCT00117312|P4|Participant Flow|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
571829|NCT00063635|O3|Outcome|Placebo|Matching placebo
556552|NCT00117676|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556553|NCT00117676|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period.
556554|NCT00117676|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC; as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) to their treatment regimen in the open-label period.
556555|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556556|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556557|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556558|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556559|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556560|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556561|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556562|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556563|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556564|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556565|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556566|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556567|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556568|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556569|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556570|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556571|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556572|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556573|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556574|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556575|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556576|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556577|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556578|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556579|NCT00117676|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556580|NCT00117676|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556581|NCT00117676|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556582|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556583|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556584|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556585|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556586|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556587|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556588|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556589|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556590|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556591|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556592|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556593|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556594|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556595|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556596|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556597|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556598|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556599|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556600|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556601|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556602|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556603|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556778|NCT00117312|P3|Participant Flow|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556604|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556605|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556606|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556607|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556608|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556609|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556610|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556611|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556612|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556613|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556614|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556615|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556616|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556617|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556618|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556619|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556620|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556621|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556622|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556623|NCT00117676|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556624|NCT00117676|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556625|NCT00117676|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.~TDF 300/mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
556626|NCT00117676|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
556627|NCT00117676|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their treatment regimen in the open-label period."
556628|NCT00117637|B3|Baseline|Total|Total of all reporting groups
556779|NCT00117312|P2|Participant Flow|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556629|NCT00117637|B2|Baseline|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556630|NCT00117637|B1|Baseline|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556631|NCT00117637|P2|Participant Flow|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556632|NCT00117637|P1|Participant Flow|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556633|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556634|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556635|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556636|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556637|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556638|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556639|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556640|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556641|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556642|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556780|NCT00117312|P1|Participant Flow|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556643|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556644|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556645|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556646|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556647|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556648|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556649|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556650|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556651|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556652|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556653|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556654|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556655|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556656|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556781|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556782|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556783|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556657|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556658|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556659|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556660|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556661|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556662|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556663|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556664|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556665|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556666|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556667|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556668|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556669|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556670|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556784|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556785|NCT00117312|O4|Outcome|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556671|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556672|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556673|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556674|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556675|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556676|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556677|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556678|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556679|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556680|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556681|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556682|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556683|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556684|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556786|NCT00117312|O3|Outcome|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556787|NCT00117312|O2|Outcome|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556788|NCT00117312|O1|Outcome|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556789|NCT00117312|E4|Reported Event|Degarelix 160 mg|Degarelix 160 mg (40 mg/mL)
556685|NCT00117637|O2|Outcome|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556686|NCT00117637|O1|Outcome|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556687|NCT00117637|O2|Outcome|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556688|NCT00117637|O1|Outcome|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556689|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556690|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556691|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556692|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556693|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556694|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556695|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556696|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556697|NCT00117637|O2|Outcome|First Interferon Then Sorafenib (Nexavar, BAY43-9006) 400 mg|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556698|NCT00117637|O1|Outcome|First Sorafenib (Nexavar, BAY43-9006) 400 mg Then 600 mg|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556790|NCT00117312|E3|Reported Event|Degarelix 120 mg|Degarelix 120 mg (30 mg/mL)
556699|NCT00117637|E4|Reported Event|Sorafenib 400 mg (After Interferon Therapy)|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556700|NCT00117637|E3|Reported Event|Sorafenib 600 mg (as Dose Escalation After 400 mg)|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556701|NCT00117637|E2|Reported Event|Interferon Therapy in Period 1|Interferon (IFN) a-2a was administered at a dose of 9 million international units(MIU) subcutaneously three times a week until progression (= first intervention period, 5.6 months [median]). Subjects initially started with a single dose of 3 MIU IFN and increased the dose as rapidly as possible to 9 MIU IFN three times a week within 1 or 2 weeks in first intervention period. After first progression, subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (BID) (ie 12-hourly) until the next progression (=second intervention period, 5.3 months [median]).
556702|NCT00117637|E1|Reported Event|Sorafenib 400 mg in Period 1|Subjects received 2 tablets of Sorafenib (200 mg tablets) twice daily (bid) (ie 12-hourly) orally until progression in (= first intervention period, 5.7 months [median] ) and 3 tablets of Sorafenib twice daily (ie 12-hourly) orally until the following progression (= second intervention period, 3.6 months [median]) on a continuous basis.
556703|NCT00117598|B4|Baseline|Total|Total of all reporting groups
556704|NCT00117598|B3|Baseline|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556705|NCT00117598|B2|Baseline|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556706|NCT00117598|B1|Baseline|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556707|NCT00117598|P5|Participant Flow|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556708|NCT00117598|P4|Participant Flow|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556709|NCT00117598|P3|Participant Flow|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556710|NCT00117598|P2|Participant Flow|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556711|NCT00117598|P1|Participant Flow|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556712|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556713|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556714|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556791|NCT00117312|E2|Reported Event|Degarelix 80 mg|Degarelix 80 mg (20 mg/mL)
556792|NCT00117312|E1|Reported Event|Degarelix 40 mg|Degarelix 40 mg (10 mg/mL)
556793|NCT00117286|B3|Baseline|Total|Total of all reporting groups
556877|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556715|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556716|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556717|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556718|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556719|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556720|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556721|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556722|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556723|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556724|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556725|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556726|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556727|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556728|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556729|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556794|NCT00117286|B2|Baseline|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556815|NCT00116857|P2|Participant Flow|Sertraline/Corn Oil|Sertraline 50mg 1 tablet by mouth everyday. Plus corn oil placebo capsules 2 g by mouth everyday.
556730|NCT00117598|O3|Outcome|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556731|NCT00117598|O2|Outcome|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556732|NCT00117598|O1|Outcome|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556733|NCT00117598|E5|Reported Event|Investigator's Choice Then Temsirolimus 175/75 mg|Participants received 1 single-agent treatment chosen by investigator until treatment cross over allowed (via Protocol Amendment 5), then temsirolimus 175 mg IV once weekly for 3 weeks; then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. AEs presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556734|NCT00117598|E4|Reported Event|Temsirolimus 175/25 mg Then 75 mg|Temsirolimus 175 mg administered IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until treatment cross over allowed (via Protocol Amendment 5), then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Adverse events (AEs) presented for these participants after they crossed over to 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556735|NCT00117598|E3|Reported Event|Investigator's Choice|"Participants received 1 single-agent treatment, chosen by investigator:~Fludarabine 25 milligram per meter squared (mg/m^2) IV daily for 5 consecutive days, every 28 days or oral administration, as needed;~Chlorambucil 0.1 (0.1-0.2) mg per kilogram, orally (mg/kg, PO) daily for 3 to 6 weeks as required or 0.4 (0.3-0.8) mg/kg PO every 21 to 28 days;~Gemcitabine 1 g/m^2 IV on Days 1, 8, and 15, every 28 days or Days 1 and 8 every 21 days;~Cyclophosphamide 300 (200-450) mg/m^2 PO daily for 5 consecutive days every 21 to 28 days, or 600 (400-1200) mg/m^2 IV every 21 to 28 days;~Cladribine 5 mg/m^2 IV daily for 5 consecutive days every 28 days for 2-6 cycles;~Etoposide 50 (50-150) mg/m^2 IV daily for 3-5 days every 21 to 28 days or 100 (50-300) mg/m^2 PO daily for 3-5 days every 21 to 28 days;~Prednisone 40 (20-60) mg/m^2 PO daily or every other day;~Dexamethasone 20 (20-40) mg PO/IV daily for 5 consecutive days every 14 to 28 days."
556736|NCT00117598|E2|Reported Event|Temsirolimus 175/25 mg|Temsirolimus 175 mg IV once weekly for 3 weeks then 25 mg temsirolimus IV once weekly until disease progression or treatment withdrawal.
556737|NCT00117598|E1|Reported Event|Temsirolimus 175/75 mg|Temsirolimus 175 milligrams (mg) administered intravenously (IV) once weekly for 3 weeks then 75 mg temsirolimus IV once weekly until disease progression or treatment withdrawal. Includes participants who received Temsirolimus 175/75 mg prior to crossover (Protocol Amendment 5).
556738|NCT00117585|B1|Baseline|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
556739|NCT00117585|P1|Participant Flow|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
556740|NCT00117585|O1|Outcome|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
556741|NCT00117585|E1|Reported Event|Arm 1|"Stepped intervention consisting of three treatment phases~Treatment 1 :~Patient Education Physical Therapy Exercises Increased Salt Intake Elevation of head of bed with 2-4 inch wedge Medication Review by MD, Pharmacist~Treatment 2 : Fludrocortisone Salt tablets~Treatment 3 : Individualized treatment based on subspecialty or orthostatic hypotension consultation at the medical center"
556742|NCT00117559|B3|Baseline|Total|Total of all reporting groups
556743|NCT00117559|B2|Baseline|Treatment as Usual|Control group
556744|NCT00117559|B1|Baseline|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
556745|NCT00117559|P2|Participant Flow|Treatment as Usual|Control group
556746|NCT00117559|P1|Participant Flow|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
556747|NCT00117559|O2|Outcome|Treatment as Usual|Control group
556748|NCT00117559|O1|Outcome|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
556749|NCT00117559|E2|Reported Event|Treatment as Ususal|Control group
556750|NCT00117559|E1|Reported Event|TEL-CBT|"Telehealth, problem solving based treatment~Telehealth Treatment: Participants receive a 15-minute telephone call for 8 weeks"
556751|NCT00117338|B3|Baseline|Total|Total of all reporting groups
556752|NCT00117338|B2|Baseline|Placebo|
556753|NCT00117338|B1|Baseline|Montelukast Intravenous (IV) 5.25 mg|
556754|NCT00117338|P2|Participant Flow|Placebo|
556755|NCT00117338|P1|Participant Flow|Montelukast Intravenous (IV) 5.25 mg|
556756|NCT00117338|O2|Outcome|Placebo|
556757|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
556758|NCT00117338|O2|Outcome|Placebo|
556759|NCT00117338|O1|Outcome|Montelukast Intravenous (IV) 5.25 mg|
556795|NCT00117286|B1|Baseline|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556796|NCT00117286|P2|Participant Flow|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556797|NCT00117286|P1|Participant Flow|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556798|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556799|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556800|NCT00117286|O2|Outcome|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556801|NCT00117286|O1|Outcome|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556802|NCT00117286|E2|Reported Event|Degarelix (80 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 80 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556803|NCT00117286|E1|Reported Event|Degarelix (60 mg to 160 mg)|Participants who completed the CS14 study in the Degarelix 60 mg (20 mg/mL) arm continued that dose into the CS14A extension study. A protocol amendment in March 2006 changed the dosage to 160 mg (40 mg/mL) for all study participants.
556804|NCT00117156|B1|Baseline|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556805|NCT00117156|P1|Participant Flow|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556806|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556807|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556808|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556809|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556810|NCT00117156|O1|Outcome|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556811|NCT00117156|E1|Reported Event|Fludarabine and Rituximab|"Fludarabine:~25 mg/m2 on days 1-5 of 28 day cycle up to 6 cycles~Rituximab:~375 mg/m2 on day 1 of 28 day cycle up to 6 cycles Rituximab dose was split between days 1 and 3 for patients with absolute lymphocyte counts > 10x10^9/L~Patients received three cycles of therapy followed by re-staging with chest/ abdomen/ pelvic CT scan. Patients with progressive disease discontinued treatment. Patients with stable or responding disease continued therapy for another 3 cycles.~Fludarabine~Rituximab"
556812|NCT00116857|B3|Baseline|Total|Total of all reporting groups
556813|NCT00116857|B2|Baseline|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
556814|NCT00116857|B1|Baseline|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
556816|NCT00116857|P1|Participant Flow|Sertraline Plus Omega-3 Supplement|Sertraline 50mg 1 tablet by mouth everyday. Plus Omega-3 supplement capsules 2g by mouth everyday.
556817|NCT00116857|O2|Outcome|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
556818|NCT00116857|O1|Outcome|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
556819|NCT00116857|E2|Reported Event|Sertraline/Corn Oil|Sertaline 50mg tablets 1 by mouth everyday, plus corn oil placebo capsules 2g by mouth everyday.
556820|NCT00116857|E1|Reported Event|Sertraline Plus Omega-3 Supplement|Sertaline 50mg tablets 1 by mouth everyday, plus Omega-3 supplement capsules 2g by mouth everyday.
556821|NCT00116831|B3|Baseline|Total|Total of all reporting groups
556822|NCT00116831|B2|Baseline|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556823|NCT00116831|B1|Baseline|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556824|NCT00116831|P2|Participant Flow|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556825|NCT00116831|P1|Participant Flow|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556826|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556827|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556828|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556829|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556830|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556831|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556832|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556833|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556834|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556835|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556836|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556837|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556838|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556839|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556840|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556841|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556842|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556843|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556844|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556845|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556846|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556847|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556848|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556849|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556850|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556851|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556852|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556853|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556854|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556855|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556856|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556857|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556858|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556859|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556860|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556861|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556862|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556863|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556864|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556865|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556866|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556867|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556868|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556869|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556870|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556871|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556872|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556873|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556874|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556875|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556876|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556878|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556879|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556880|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556881|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556882|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556883|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556884|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556885|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556886|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556887|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556888|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556889|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556890|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556891|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556892|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556893|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556894|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556895|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556896|NCT00116831|O2|Outcome|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556897|NCT00116831|O1|Outcome|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556898|NCT00116831|E2|Reported Event|Rosiglitazone (RSG) 4 mg|Rosiglitazone (RSG) 4 mg once daily for 18 months
556899|NCT00116831|E1|Reported Event|Glipizide (GLP) 5 mg|Glipizide (GLP) 5 mg once daily for 18 months
556900|NCT00116805|B3|Baseline|Total|Total of all reporting groups
556901|NCT00116805|B2|Baseline|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556902|NCT00116805|B1|Baseline|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556903|NCT00116805|P2|Participant Flow|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556904|NCT00116805|P1|Participant Flow|TDF-TDF|Tenofovir disoproxil fumarate (TDF) 300 mg plus placebo to match adefovir dipivoxil (ADV) (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added emtricitabine (FTC) to their treatment regimen (as part of FTC 200 mg/TDF 300 mg fixed-dose combination (FDC) tablet) in the open-label period.
556905|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556906|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556907|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556908|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556909|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556910|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556911|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556912|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556913|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556914|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556915|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556916|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
557028|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
556917|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556918|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556919|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556920|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556921|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556922|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556923|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556924|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556925|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556926|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556927|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556928|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556929|NCT00116805|O4|Outcome|ADV-TDF With Addition of FTC|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556930|NCT00116805|O3|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556931|NCT00116805|O2|Outcome|TDF-TDF With Addition of FTC|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group added FTC (as part of FTC 200 mg/TDF 300 mg FDC tablet) to their study regimen in the open-label period.
556932|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants in this reporting group did not add FTC to their study regimen in the open-label period.
556933|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556934|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556935|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556936|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556937|NCT00116805|O2|Outcome|ADV-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556938|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556939|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556940|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556941|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556942|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
557166|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
556943|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556944|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556945|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556946|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556947|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556948|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556949|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556950|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556951|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556952|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556953|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556954|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556955|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556956|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556957|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556958|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556959|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556960|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556961|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556962|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556963|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556964|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556965|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556966|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556967|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556968|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
557167|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
556969|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556970|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period..
556971|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556972|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556973|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556974|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556975|NCT00116805|O2|Outcome|ADV-TDF|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556976|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556977|NCT00116805|O2|Outcome|ADV 10 mg|ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556978|NCT00116805|O1|Outcome|TDF-TDF|TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period.
556979|NCT00116805|E3|Reported Event|Open-Label TDF|"Adverse events for this reporting group include those occurring during the open-label TDF 300 mg period (Week 49 up to Week 384), regardless of which group they were randomized to in the double-blind period.~TDF 300/mg+ADV placebo or ADV 10 mg+TDF placebo (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
556980|NCT00116805|E2|Reported Event|Double-Blind ADV|"Adverse events this reporting group include those occurring in the ADV-TDF group during the double-blind period only (baseline to Week 48).~ADV 10 mg plus placebo to match TDF (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
556981|NCT00116805|E1|Reported Event|Double-Blind TDF|"Adverse events this reporting group include those occurring in the TDF-TDF group during the double-blind period only (baseline to Week 48).~TDF 300 mg plus placebo to match ADV (double-blind period), followed by TDF 300 mg (open-label period). Participants may have added FTC to their treatment regimen (as part of FTC 200 mg/TDF 300 mg FDC tablet) in the open-label period."
556982|NCT00116779|B3|Baseline|Total|Total of all reporting groups
556983|NCT00116779|B2|Baseline|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556984|NCT00116779|B1|Baseline|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556985|NCT00116779|P2|Participant Flow|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556986|NCT00116779|P1|Participant Flow|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556987|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556988|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556989|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556990|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556991|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556992|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556993|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556994|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
571830|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
556995|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556996|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556997|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
556998|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
556999|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557000|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557001|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557002|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557003|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557004|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557005|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557006|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557007|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557008|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557009|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557010|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557011|NCT00116779|O2|Outcome|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557012|NCT00116779|O1|Outcome|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557013|NCT00116779|E2|Reported Event|Degarelix 80mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 80 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2 - 13.
557014|NCT00116779|E1|Reported Event|Degarelix 60mg|Initial dose of 200 milligrams of Degarelix on Day 0 (cycle 1) given by subcutaneous injection. Maintenance dose of 60 milligrams of Degarelix given by subcutaneous injection every 28 days for cycles 2-13.
557015|NCT00116753|B4|Baseline|Total|Total of all reporting groups
557016|NCT00116753|B3|Baseline|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557017|NCT00116753|B2|Baseline|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557018|NCT00116753|B1|Baseline|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557019|NCT00116753|P3|Participant Flow|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557020|NCT00116753|P2|Participant Flow|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557021|NCT00116753|P1|Participant Flow|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557022|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557023|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557024|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557025|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557026|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557027|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
571831|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
557029|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557030|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557031|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557032|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557033|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557034|NCT00116753|O3|Outcome|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557035|NCT00116753|O2|Outcome|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557036|NCT00116753|O1|Outcome|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557037|NCT00116753|E3|Reported Event|Degarelix 240@40/240@60 (1,4,7,10)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 4, 7 and 10.
557038|NCT00116753|E2|Reported Event|Degarelix 240@40/240@60 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (60 mg/mL) at months 1, 3, 6 and 9.
557039|NCT00116753|E1|Reported Event|Degarelix 240@40/240@40 (1,3,6,9)|240 mg (40 mg/mL) initiation dose, maintenance dose 240 mg (40 mg/mL) at months 1, 3, 6 and 9.
557040|NCT00116688|B3|Baseline|Total|Total of all reporting groups
557041|NCT00116688|B2|Baseline|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557042|NCT00116688|B1|Baseline|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557043|NCT00116688|P2|Participant Flow|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557044|NCT00116688|P1|Participant Flow|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557045|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557046|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557047|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557048|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557049|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557050|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557051|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557052|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557168|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
571832|NCT00063635|O3|Outcome|Placebo|Matching placebo
557053|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557054|NCT00116688|O2|Outcome|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557055|NCT00116688|O1|Outcome|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557056|NCT00116688|E2|Reported Event|Romiplostim in Pediatric Population|Romiplostim administered to pediatric participants subcutaneously weekly at doses up to 10 µg/kg based on platelet counts.
557057|NCT00116688|E1|Reported Event|Romiplostim in Adults|Romiplostim administered to adult participants subcutaneously weekly at doses up to 30 µg/kg based on platelet counts. After Amendment 1 the maximum weekly dose was reduced to 15 µg/kg, and after Amendment 2 the maximum weekly dose was reduced to 10 µg/kg. However, participants enrolled prior to Amendment 2 who were receiving >10 µg/kg were permitted to remain on that higher dose, but could not increase their dose. In addition, if the participant's dose was decreased, it could not be increased to >10 µg/kg.
557058|NCT00116649|B1|Baseline|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
557059|NCT00116649|P1|Participant Flow|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
557060|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
557061|NCT00116649|O1|Outcome|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
557062|NCT00116649|E1|Reported Event|Aldara (Imiquimod) Cream|Aldara (imiquimod) Cream 5%
557063|NCT00116428|B3|Baseline|Total|Total of all reporting groups
557064|NCT00116428|B2|Baseline|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
557065|NCT00116428|B1|Baseline|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557066|NCT00116428|P2|Participant Flow|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
557067|NCT00116428|P1|Participant Flow|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557068|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
557069|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control subjects underwent a study ablation procedure after failing the effectiveness endpoint.
557070|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557071|NCT00116428|O3|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame.
557072|NCT00116428|O2|Outcome|Antiarrhythmic Drug Subjects Undergoing Ablation|Control Group Subjects underwent a study ablation procedure after failing the effectiveness endpoint.
557073|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557074|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
557075|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557076|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
557077|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557078|NCT00116428|O2|Outcome|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame OR underwent a study ablation procedure after failing the effectiveness endpoint.
557079|NCT00116428|O1|Outcome|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557080|NCT00116428|E2|Reported Event|Antiarrhythmic Drug|The antiarrhythmic drug (control group) is defined as class I, class III or atrioventricular nodal blocking agents such as beta blocking agents (BB) or calcium channel blockers (CCB). During the two-week dosing period, the subject's medication was titrated up for maximum efficacy for the treatment of paroxysmal atrial fibrillation. The subject was maintained on the same drug for the rest of study time frame AND didn't undergo a study ablation procedure.
557081|NCT00116428|E1|Reported Event|NAVISTAR® THERMOCOOL® Catheter|Subjects who were randomized to the THERMOCOOL group, i.e., to receive NAVISTAR® THERMOCOOL® Catheter at randomization; OR received the Catheter after failing the effectiveness endpoint. The Biosense Webster NAVISTAR® THERMOCOOL® Diagnostic/Ablation Deflectable Tip Catheter is a luminal catheter with a deflectable tip designed to facilitate electrophysiological mapping of the heart and to transmit radiofrequency current to the catheter tip electrode for ablation purposes.
557082|NCT00116272|B3|Baseline|Total|Total of all reporting groups
557083|NCT00116272|B2|Baseline|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557084|NCT00116272|B1|Baseline|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557085|NCT00116272|P2|Participant Flow|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557086|NCT00116272|P1|Participant Flow|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557087|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557088|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557089|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557090|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557091|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557092|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557093|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557094|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557095|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557096|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
571833|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
557097|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557098|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557099|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557100|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557101|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557102|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557103|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557104|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557105|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557106|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557107|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557108|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557109|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557110|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557111|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557112|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557113|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557114|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557115|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557116|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557117|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557118|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557119|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557120|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557121|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557122|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557123|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557169|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557124|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557125|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557126|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557127|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557128|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557129|NCT00116272|O2|Outcome|Diseased Controls|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557130|NCT00116272|O1|Outcome|Etanercept-Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557131|NCT00116272|E4|Reported Event|Infants Etanercept Exposed|Infants born to pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557132|NCT00116272|E3|Reported Event|Infants Diseased Control|Infants born to pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557133|NCT00116272|E2|Reported Event|Mothers Etanercept Exposed|Pregnant women with a current diagnosis of rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA), ankylosing spondylitis (AS), psoriatic arthritis (PsoA) or psoriasis (PsO) who used etanercept in the first trimester of pregnancy for any length of time.
557134|NCT00116272|E1|Reported Event|Mothers Diseased Control|Pregnant women with a current diagnosis of RA, JRA, AS, PsA, or PsO who did not use etanercept or any tumor necrosis factor (TNF) antagonist during pregnancy.
557135|NCT00116207|B3|Baseline|Total|Total of all reporting groups
557136|NCT00116207|B2|Baseline|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557137|NCT00116207|B1|Baseline|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557138|NCT00116207|P2|Participant Flow|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557139|NCT00116207|P1|Participant Flow|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557140|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557141|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557142|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557143|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557144|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557145|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557146|NCT00116207|O2|Outcome|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557147|NCT00116207|O1|Outcome|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557148|NCT00116207|E2|Reported Event|Placebo|"Placebo administered twice daily.~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557149|NCT00116207|E1|Reported Event|ORAL ANTIOXIDANT|"Allopurinol (300mg daily), ALA (600mg twice daily) nicotinamide (750 mg twice daily) Given orally~ORAL ANTIOXIDANT: Comparison of triple antioxidant therapy to placebo"
557150|NCT00116168|B5|Baseline|Total|Total of all reporting groups
557151|NCT00116168|B4|Baseline|MEDI-528 9 mg|
557152|NCT00116168|B3|Baseline|MEDI-528 3 mg|
557153|NCT00116168|B2|Baseline|MEDI-528 1 mg|
557154|NCT00116168|B1|Baseline|MEDI-528 0.3 mg|
557155|NCT00116168|P4|Participant Flow|MEDI-528 9 mg|
557156|NCT00116168|P3|Participant Flow|MEDI-528 3 mg|
557157|NCT00116168|P2|Participant Flow|MEDI-528 1 mg|
557158|NCT00116168|P1|Participant Flow|MEDI-528 0.3 mg|
557159|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557160|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557161|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557162|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557163|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557164|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557165|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557170|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557171|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557172|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557173|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557174|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557175|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557176|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557177|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557178|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557179|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557180|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557181|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557182|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557183|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557184|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557185|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557186|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557187|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557188|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557189|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557190|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557191|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557192|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557193|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557194|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557195|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557196|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557197|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557198|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557199|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557200|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557201|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557202|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557203|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557204|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557205|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557206|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557207|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557208|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557209|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557210|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557211|NCT00116168|O4|Outcome|MEDI-528 9 mg/kg|MEDI-528 (9 mg/kg) administered as a single, SC dose
557212|NCT00116168|O3|Outcome|MEDI-528 3 mg/kg|MEDI-528 (3 mg/kg) administered as a single, SC dose
557213|NCT00116168|O2|Outcome|MEDI-528 1 mg/kg|MEDI-528 (1 mg/kg) administered as a single, SC dose
557214|NCT00116168|O1|Outcome|MEDI-528 0.3 mg/kg|MEDI-528 (0.3 mg/kg) administered as a single, subcutaneous (SC) dose
557215|NCT00116168|E4|Reported Event|MEDI-528 9 mg|
557216|NCT00116168|E3|Reported Event|MEDI-528 3 mg|
557217|NCT00116168|E2|Reported Event|MEDI-528 1 mg|
557218|NCT00116168|E1|Reported Event|MEDI-528 0.3 mg|
557219|NCT00115349|B3|Baseline|Total|Total of all reporting groups
557220|NCT00115349|B2|Baseline|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
557221|NCT00115349|B1|Baseline|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
557222|NCT00115349|P2|Participant Flow|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
557223|NCT00115349|P1|Participant Flow|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
557224|NCT00115349|O2|Outcome|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
557225|NCT00115349|O1|Outcome|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
557226|NCT00115349|E2|Reported Event|Deferoxamine (DFO) + Monotherapy|"DFO + Placebo DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~Placebo Administered orally three times daily."
557227|NCT00115349|E1|Reported Event|Deferoxamine (DFO) and Deferiprone (L1) Combination Therapy|"DFO + L1 DFO Administered daily at 50-60 mg/kg for 12-24 hr/day 7 days a week either subcutaneous or intravenous.~L1 Administered daily at 75 mg/kg in 3 divided doses taken orally and timed so that 2 of 3 doses will be simultaneous with DFO infusion."
557228|NCT00115297|B3|Baseline|Total|Total of all reporting groups
557229|NCT00115297|B2|Baseline|Placebo|"Placebo (placebo tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old received placebo montelukast granules."
557230|NCT00115297|B1|Baseline|Montelukast|"5-mg montelukast tablets or 4 mg granules~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old received 4-mg montelukast granules."
557231|NCT00115297|P2|Participant Flow|Placebo|"Placebo (montelukast tablet or montelukast granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
557232|NCT00115297|P1|Participant Flow|Monteluksat|"5-mg montelukast tablets or 4 mg granules)~Montelukast: Participants who are 2 to 3 years old will receive 5-mg montelukast tablets and participants who are 12 months to 2 years old will receive 4-mg montelukast granules."
557233|NCT00115297|O2|Outcome|Placebo|"Placebo (tablets or granules)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
557234|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
557235|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who were 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
557236|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
557237|NCT00115297|O2|Outcome|Placebo|"Placebo (montelukast tablets)~Placebo: Participants who are 2 to 3 years old received placebo montelukast tablets and participants who were 12 months to 2 years old received placebo montelukast granules."
557238|NCT00115297|O1|Outcome|Montelukast|"5-mg montelukast tablets~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
557239|NCT00115297|E2|Reported Event|Placebo|"Placebo (tablets or granules)~Placebo: Participants who are 2 to 3 years old will receive placebo montelukast tablets and participants who are 12 months to 2 years old will receive placebo montelukast granules."
557240|NCT00115297|E1|Reported Event|Montelukast|"Montelukast tablets or granules~Montelukast: Participants who are 2 to 3 years old received 5-mg montelukast tablets and participants who were 12 months to 2 years old received 4-mg montelukast granules."
557241|NCT00115934|B3|Baseline|Total|Total of all reporting groups
557242|NCT00115934|B2|Baseline|RVPAS|Right ventricular to pulmonary artery shunt
557243|NCT00115934|B1|Baseline|MBTS|Blalock-Taussig pulmonary artery shunt
557244|NCT00115934|P2|Participant Flow|RVPAS|Right ventricular to pulmonary artery shunt
557245|NCT00115934|P1|Participant Flow|MBTS|Blalock-Taussig pulmonary artery shunt
557246|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557247|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557248|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557249|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557250|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557251|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557252|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557253|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557254|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557255|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557256|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557257|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557258|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557259|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557260|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557261|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557262|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557263|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557264|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557265|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557266|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557267|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557268|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557269|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557270|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557271|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557272|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557273|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557274|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557276|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557277|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557278|NCT00115934|O2|Outcome|RVPAS|Right ventricular to pulmonary artery shunt
557279|NCT00115934|O1|Outcome|MBTS|Blalock-Taussig pulmonary artery shunt
557280|NCT00115934|E2|Reported Event|RVPAS|Right ventricular to pulmonary artery shunt
557281|NCT00115934|E1|Reported Event|MBTS|Blalock-Taussig pulmonary artery shunt
557282|NCT00115869|B3|Baseline|Total|Total of all reporting groups
557283|NCT00115869|B2|Baseline|Social Influences School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
557284|NCT00115869|B1|Baseline|No-intervention Control|No-intervention control group
557285|NCT00115869|P2|Participant Flow|Grade 3-12 School-based Intervention|Grade 3-12 school-influences school-based smoking prevention intervention
557286|NCT00115869|P1|Participant Flow|No-intervention Control|No-intervention control group
557287|NCT00115869|O2|Outcome|School-based Smoking Prevention Curriculum|Social influences school-based smoking prevention curriculum group
557288|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control group
557289|NCT00115869|O2|Outcome|Social Influences School-based Smoking Prevention Curriculum|School-based social-influences smoking prevention curriculum condition
557290|NCT00115869|O1|Outcome|No-intervention Control|No-intervention control condition
557291|NCT00115869|E2|Reported Event|School-based Smoking Prevention Curriculum Group|school-based smoking prevention curriculum
557292|NCT00115869|E1|Reported Event|No-intervention Control Group|no-intervention control
557293|NCT00115804|B1|Baseline|Fluoxetine|All eligible patients were given fluoxetine
557294|NCT00115804|P1|Participant Flow|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557295|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557296|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557297|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557298|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557299|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557300|NCT00115804|O1|Outcome|Fluoxetine|All patients receiving Fluoxetine starting at 10 mg/day
557301|NCT00115804|O1|Outcome|Fluoxetine|"All eligible patients were started on Fluoxetine at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily.~Fluoxetine: fluoxetine po 10-60 mg/day for 12 weeks~Fluoxetine: Fluoxetine was started at 10 mg once daily. The dose was flexibly dosed based on pain efficacy and tolerability to a final dose between 10 and 60 mg once daily."
557302|NCT00115804|O1|Outcome|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
557303|NCT00115804|E1|Reported Event|Fluoxetine|Fluoxetine was started at 10 mg/day and adjusted based on pain efficacy and tolerability.
557304|NCT00115765|B5|Baseline|Total|Total of all reporting groups
557305|NCT00115765|B4|Baseline|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557306|NCT00115765|B3|Baseline|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557307|NCT00115765|B2|Baseline|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557308|NCT00115765|B1|Baseline|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557309|NCT00115765|P4|Participant Flow|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557310|NCT00115765|P3|Participant Flow|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557311|NCT00115765|P2|Participant Flow|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557312|NCT00115765|P1|Participant Flow|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557313|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557314|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557315|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557316|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557317|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557318|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557319|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557320|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557321|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557322|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557323|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557324|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557325|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557326|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557327|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557328|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557329|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557330|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557331|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557332|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557333|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557334|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557335|NCT00115765|O2|Outcome|Irinotecan and Bevacizumab Without Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W alone
557336|NCT00115765|O1|Outcome|Irinotecan and Bevacizumab Plus Panitumumab|Irinotecan-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557337|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557338|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557339|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557340|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557341|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557342|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557343|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557344|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557345|NCT00115765|O2|Outcome|Oxaliplatin and Bevacizumab Without Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W alone
557346|NCT00115765|O1|Outcome|Oxaliplatin and Bevacizumab Plus Panitumumab|Oxaliplatin-based chemotherapy and Bevacizumab Q2W plus panitumumab 6 mg/kg Q2W
557347|NCT00115765|E2|Reported Event|Bevacizumab With Chemotherapy|
557348|NCT00115765|E1|Reported Event|Panit. Plus Bevacizumab With Chemotherapy|
557349|NCT00115739|B1|Baseline|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
557350|NCT00115739|P1|Participant Flow|Imatinib (Gleevec) Tablets|4 (100 mg tablets) = 400 mg dose twice per day (morning and evening) for 16 weeks
557351|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
557352|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
557353|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|
557354|NCT00115739|O1|Outcome|Imatinib (Gleevec) Tablets|Subjects were administered oral Gleevec tablets, then tumor response was assessed
557355|NCT00115739|E1|Reported Event|Imatinib (Gleevec) Tablets|patients with Anaplastic thyroid cancer were administered Gleevec tablets From February 2004 to May 2007
557356|NCT00115063|B3|Baseline|Total|Total of all reporting groups
557357|NCT00115063|B2|Baseline|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557358|NCT00115063|B1|Baseline|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557359|NCT00115063|P2|Participant Flow|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557360|NCT00115063|P1|Participant Flow|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557361|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557362|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557363|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557364|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557365|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557366|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557367|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557368|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557369|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557370|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557371|NCT00115063|O2|Outcome|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557372|NCT00115063|O1|Outcome|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
571834|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
557373|NCT00115063|E2|Reported Event|Access to Weight Loss Informational Website|Access to Weight Loss Informational Website sponsored by the Mayo Clinic
557374|NCT00115063|E1|Reported Event|Intensive Medical Intervention|"Intensive Medical Intervention including Low Calorie Liquid Diet, Weight loss medications, Group Behavioral Therapy and a Tool Box approach"
557375|NCT00114972|B3|Baseline|Total|Total of all reporting groups
557376|NCT00114972|B2|Baseline|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557377|NCT00114972|B1|Baseline|CABG|Coronary Artery By-pass Graft (CABG)
557378|NCT00114972|P2|Participant Flow|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557379|NCT00114972|P1|Participant Flow|CABG|Coronary Artery By-pass Graft (CABG)
557380|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557381|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557382|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557383|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557384|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557385|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557386|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557387|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557388|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557389|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557390|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557391|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557392|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557393|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557394|NCT00114972|O2|Outcome|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557395|NCT00114972|O1|Outcome|CABG|Coronary Artery By-pass Graft (CABG)
557396|NCT00114972|E2|Reported Event|PCI With DES|Percutaneous coronary intervention (PCI) using TAXUS Express Drug Eluting Stent (DES)
557397|NCT00114972|E1|Reported Event|CABG|Coronary Artery By-pass Graft (CABG)
557398|NCT00114959|B1|Baseline|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557399|NCT00114959|P1|Participant Flow|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557400|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557401|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557402|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557403|NCT00114959|O1|Outcome|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557404|NCT00114959|E1|Reported Event|Homoharringtonine + Imatinib Mesylate|Participants are administered homoharringtonine (omacetaxine) 2.5 mg/m^2 by continuous 24-hour intravenous infusion daily on Days 1-5 of each 4 week treatment cycle, and imatinib mesylate (Gleevec) by mouth with a daily dose of 400 mg for participants in the chronic phase of chronic myeloid leukemia (CML) or 600 mg for participants in the accelerated or blast phase of CML.
557405|NCT00114634|B1|Baseline|Egg Yolk or no Egg Yolk|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
557406|NCT00114634|P1|Participant Flow|Egg Yolk or no Egg Yolk|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
557407|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
557408|NCT00114634|O1|Outcome|Placebo|egg substitute
557409|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
557410|NCT00114634|O1|Outcome|Placebo|egg substitute
557411|NCT00114634|O2|Outcome|Cholesterol|pasteurized egg yolk
557417|NCT00114634|O1|Outcome|Crossover Study|This was a double-blind, placebo-controlled, cross-over design. The trial was composed of five 2-week phases. Two phases, phases 2 and 4, were double-blinded. During these phases, subjects were either on placebo (egg substitute with no cholesterol) or cholesterol supplementation (pasteurized egg yolk). During the interval phases, 1, 3 and 5, subjects were maintained on baseline therapy of 150 mg/kg/day of crystalline cholesterol suspended in Ora-Plus. Order of placebo versus cholesterol was random with 6 subjects receiving placebo first (in phase 2) and 4 subjects receiving cholesterol containing pasteurized egg yolk first. 13 subjects were enrolled, only 10 subjects completed the study.
557418|NCT00114634|E1|Reported Event|Group 1|All subjects were on cholesterol suspension or egg yolk versus no egg yolk.
557419|NCT00114504|B3|Baseline|Total|Total of all reporting groups
557420|NCT00114504|B2|Baseline|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
557421|NCT00114504|B1|Baseline|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
557422|NCT00114504|P2|Participant Flow|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
557423|NCT00114504|P1|Participant Flow|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
557424|NCT00114504|O4|Outcome|Control Group at 3 Months|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone for 3 months.
557425|NCT00114504|O3|Outcome|Control Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone at baseline
557426|NCT00114504|O2|Outcome|Simvastatin Group at 3 Month|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
557427|NCT00114504|O1|Outcome|Simvastatin Group Baseline|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy at baseline
557428|NCT00114504|O2|Outcome|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone or 3 months
557429|NCT00114504|O1|Outcome|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy for 3 months
557430|NCT00114504|E2|Reported Event|Control Group|Patients with FDG-positive carotid artery and/or aorta who received diet therapy alone
557431|NCT00114504|E1|Reported Event|Simvastatin Group|Patients with FDG-positive carotid artery and/or aorta who received simvastatin and diet therapy
557432|NCT00114244|B3|Baseline|Total|Total of all reporting groups
557433|NCT00114244|B2|Baseline|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557434|NCT00114244|B1|Baseline|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557435|NCT00114244|P2|Participant Flow|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557436|NCT00114244|P1|Participant Flow|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557437|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557438|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557439|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557440|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557441|NCT00114244|O2|Outcome|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and 1000 mg/m2 gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557442|NCT00114244|O1|Outcome|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557443|NCT00114244|E2|Reported Event|Arm II (Sorafenib Tosylate, Gemcitabine Hydrochloride)|"Patients receive 400 mg oral sorafenib as in Arm I and gemcitabine IV over 100 minutes on days 1, 8, and 15.~sorafenib tosylate: Given PO~gemcitabine hydrochloride: Given IV~laboratory biomarker analysis: Correlative studies"
557444|NCT00114244|E1|Reported Event|Arm I (Sorafenib Tosylate)|"Patients receive 400 mg oral sorafenib twice daily on days 1-28. Patients experiencing disease progression cross over to Arm II.~sorafenib tosylate: Given PO~laboratory biomarker analysis: Correlative studies"
557445|NCT00114166|B1|Baseline|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
557446|NCT00114166|P1|Participant Flow|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
557684|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557447|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
557448|NCT00114166|O1|Outcome|Topotecan|Includes both Regimen I Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy and Regimen II Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
557449|NCT00114166|E2|Reported Event|Regimen II|Topotecan 4.0 mg/m2 IV day 1, 8 and 15 of a 28-day cycle until disease progression or adverse effects prohibit further therapy
557450|NCT00114166|E1|Reported Event|Regimen I|Topotecan 1.25 mg/m2 IV days 1-5 of a 21-day cycle until disease progression or adverse effects prohibit further therapy
557451|NCT00114127|B3|Baseline|Total|Total of all reporting groups
557452|NCT00114127|B2|Baseline|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
557453|NCT00114127|B1|Baseline|Duloxetine 60mg/Day + Placebo for 18 Weeks(Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
557454|NCT00114127|P2|Participant Flow|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
557455|NCT00114127|P1|Participant Flow|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
557456|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
557457|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
557458|NCT00114127|O2|Outcome|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
557459|NCT00114127|O1|Outcome|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
557460|NCT00114127|E2|Reported Event|Duloxetine 120mg/Day for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 15 received 120mg duloxetine for 18 additional weeks.
557461|NCT00114127|E1|Reported Event|Duloxetine 60mg/Day + Placebo for 18 Weeks (Phase 2)|Participants who did not achieve remission at the end of Phase 1 entered Phase 2 and were randomized. 13 received 60mg duloxetine plus placebo for 18 additional weeks.
557462|NCT00114101|B3|Baseline|Total|Total of all reporting groups
557463|NCT00114101|B2|Baseline|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557464|NCT00114101|B1|Baseline|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557465|NCT00114101|P2|Participant Flow|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557466|NCT00114101|P1|Participant Flow|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557467|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557468|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557469|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557470|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557471|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily.~(closed as of 12/17/09)"
557472|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily.
557473|NCT00114101|O2|Outcome|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557474|NCT00114101|O1|Outcome|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557475|NCT00114101|E2|Reported Event|Placebo Maintenance|"Beginning between day 100-110, patients receive oral placebo once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.~(closed as of 12/17/09)"
557476|NCT00114101|E1|Reported Event|Lenalidomide Maintenance|Beginning between day 100-110, patients receive oral lenalidomide once daily - 10 mg/day for the first 3 months, then if tolerated, 15 mg/day.
557477|NCT00113022|B3|Baseline|Total|Total of all reporting groups
557478|NCT00113022|B2|Baseline|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557685|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557479|NCT00113022|B1|Baseline|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557480|NCT00113022|P2|Participant Flow|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557481|NCT00113022|P1|Participant Flow|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557482|NCT00113022|O2|Outcome|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557483|NCT00113022|O1|Outcome|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557484|NCT00113022|E2|Reported Event|Placebo|Blinded placebo. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557485|NCT00113022|E1|Reported Event|Org 24448|Blinded, active experimental compound. Dosing starts at 250 mg once per day for one week, then 250 mg twice per day for one week, then 500 mg twice per day. After 4 weeks with insufficient response, the dose may be increased to 750 mg twice per day. The titration schedule may be delayed if the subject is experiencing adverse effects. The subject may be increased or decreased at the discretion of the investigator. The minimum dose allowed for the study is 250 mg once per day.
557486|NCT00113919|B1|Baseline|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
557487|NCT00113919|P1|Participant Flow|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
557488|NCT00113919|O1|Outcome|Busulfex|
557489|NCT00113919|E1|Reported Event|Bisulfan|Bisulfan in Multiple Myeloma patients >65 years w/renal insufficiency
557490|NCT00113880|B4|Baseline|Total|Total of all reporting groups
557491|NCT00113880|B3|Baseline|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557492|NCT00113880|B2|Baseline|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557493|NCT00113880|B1|Baseline|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557494|NCT00113880|P3|Participant Flow|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557495|NCT00113880|P2|Participant Flow|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557686|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557758|NCT00113321|B1|Baseline|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
557496|NCT00113880|P1|Participant Flow|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the KP Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose. FluMist recipients served as their own controls based on the observation time after vaccination. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557497|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
557498|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
557499|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
557500|NCT00113880|O3|Outcome|FluMist Recipients (18-49 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
557501|NCT00113880|O2|Outcome|FluMist Recipients (9-17 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects ≥ 9 years of age were expected to receive only 1 dose.
557502|NCT00113880|O1|Outcome|FluMist Recipients (5-8 Years Old)|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist.
557503|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557504|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557505|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557506|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557507|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557508|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557509|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557510|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557511|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557512|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557687|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557759|NCT00113321|P1|Participant Flow|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
557513|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557514|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557515|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557516|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557517|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557518|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557519|NCT00113880|O2|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557520|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557521|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557522|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557523|NCT00113880|O3|Outcome|Unvaccinated Controls|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557524|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557525|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557526|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557527|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557688|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557689|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557690|NCT00113516|E2|Reported Event|Sunitinib 50 mg (Part 2)|
557528|NCT00113880|O2|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557529|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557530|NCT00113880|O2|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557531|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557532|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557533|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557534|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557535|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557536|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557537|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557538|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557539|NCT00113880|O4|Outcome|TIV-Vaccinated Control|Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557540|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557541|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557542|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557543|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557544|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557545|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557546|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557547|NCT00113880|O4|Outcome|TIV-Vaccinated Control|TIV-Vaccinated Control Non-randomized TIV-vaccinated subjects matched 1:1 with FluMist recipients and were selected from the pool of individuals who received TIV but not FluMist at the Kaiser HMO during the same month that the reference FluMist recipient was vaccinated. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, ED, and clinic visits), and medical center (only for subjects from Northern California).
557548|NCT00113880|O3|Outcome|Unvaccinated Control|Non-randomized unvaccinated subjects were matched 1:1 with FluMist recipients and were selected from the pool of individuals who were members of the Kaiser Health Maintenance Organization (HMO) during the same month that the reference FluMist recipient was vaccinated, and included only those who did not receive the trivalent inactivated influenza vaccine (TIV) formulation at the Kaiser HMO. Other matching factors included age (within 1 year), gender, prior year health care utilization level (ie, similar number of hospital, emergency department (ED), and clinic visits), and medical center (only for subjects from Northern California).
557549|NCT00113880|O2|Outcome|Within Cohort Control|FluMist recipients served as their own controls based on the observation time after vaccination. FluMist vaccinated cohort served as its own control. In the primary analyses using within-cohort controls, “risk” periods of Days 0 to 3 and Days 0 to 21 post vaccination were compared to “reference” observation time occurring after the respective risk periods, ie, Days 4 to 42 for the risk period of Days 0 to 3 and Days 22 to 42 for the risk period of Days 0 to 21.
557550|NCT00113880|O1|Outcome|FluMist Recipients|Subjects who had been immunized with FluMist as part of routine clinical practice at health care centers within the Kaiser Permanente Health Care Plan. Subjects from 5-8 years of age may have received 1 or 2 doses of FluMist, while subjects ≥ 9 years of age were expected to receive only 1 dose.
557551|NCT00113880|E1|Reported Event|FluMist Recipients|
557552|NCT00113841|B3|Baseline|Total|Total of all reporting groups
557553|NCT00113841|B2|Baseline|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
557554|NCT00113841|B1|Baseline|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
557555|NCT00113841|P2|Participant Flow|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
557556|NCT00113841|P1|Participant Flow|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
557557|NCT00113841|O2|Outcome|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
557558|NCT00113841|O1|Outcome|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
557559|NCT00113841|E2|Reported Event|Curcumin + Bioperine|Curcumin starting dose 2 grams orally in 2 divided doses (a.m., p.m.) and Bioperine 5 mg orally twice daily
557560|NCT00113841|E1|Reported Event|Curcumin|Curcumin starting dose 2 grams orally in two divided doses (a.m., p.m.)
557561|NCT00113763|B3|Baseline|Total|Total of all reporting groups
557562|NCT00113763|B2|Baseline|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557563|NCT00113763|B1|Baseline|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557564|NCT00113763|P2|Participant Flow|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557565|NCT00113763|P1|Participant Flow|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557691|NCT00113516|E1|Reported Event|Carboplatin Plus Paclitaxel 172-225 mg/m2 (Part 1)|
557692|NCT00113490|B3|Baseline|Total|Total of all reporting groups
571835|NCT00063635|O3|Outcome|Placebo|Matching placebo
557566|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557567|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557568|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557569|NCT00113763|O1|Outcome|Panitumumab Plus Best Supportive Care|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557570|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557571|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557572|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557573|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557574|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557575|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557576|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557577|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557578|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557579|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557580|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557581|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557582|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557583|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557693|NCT00113490|B2|Baseline|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557724|NCT00113425|E2|Reported Event|Untreated Group Control|The contralateral side of the face remained untreated, thus serving as an internal control.
557584|NCT00113763|O2|Outcome|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557585|NCT00113763|O1|Outcome|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557586|NCT00113763|E2|Reported Event|BSC Alone|Best supportive care defined as the best care available as judged appropriate by the investigator and according to institutional guidelines, including antibiotics, analgesics, radiation therapy for pain control (limited to bone metastases), corticosteroids, transfusions, psychotherapy, growth factors, palliative surgery, or any symptomatic therapy as clinically indicated. For the purpose of this study, best supportive care does not include anti-neoplastic chemotherapy.
557587|NCT00113763|E1|Reported Event|Panitumumab Plus BSC|Panitumumab plus best supportive care (BSC). Panitumumab was administered by intravenous infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease or were unable to tolerate study drug.
557588|NCT00113607|B3|Baseline|Total|Total of all reporting groups
557589|NCT00113607|B2|Baseline|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557590|NCT00113607|B1|Baseline|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557591|NCT00113607|P2|Participant Flow|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557592|NCT00113607|P1|Participant Flow|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557593|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557594|NCT00113607|O1|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557595|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557596|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557597|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557598|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557599|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557600|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557601|NCT00113607|O2|Outcome|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557602|NCT00113607|O1|Outcome|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557603|NCT00113607|E2|Reported Event|DOXIL|50 mg/m2 DOXIL administered as a 90-minute intravenous (IV) infusion, every 4 weeks
557604|NCT00113607|E1|Reported Event|Trabectedin/DOXIL|30 mg/m2 DOXIL administered as a 90-minute IV infusion followed by 1.1 mg/m2 trabectedin as a 3-hour IV infusion, every 3 weeks
557605|NCT00113568|B1|Baseline|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557606|NCT00113568|P1|Participant Flow|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557607|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557608|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557609|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557610|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557611|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557612|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557613|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557614|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557615|NCT00113568|O1|Outcome|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557616|NCT00113568|E1|Reported Event|Tranexamic Acid Tablets (XP12B)|Two 650 mg tranexamic acid tablets taken 3 times daily (3900 mg/day) for a maximum of 5 days during monthly menstruation
557617|NCT00113529|B1|Baseline|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557760|NCT00113321|O1|Outcome|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
557618|NCT00113529|P1|Participant Flow|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 milligrams (mg) or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557619|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557620|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557621|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557622|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557623|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557624|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557625|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557626|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557627|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557628|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557629|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557757|NCT00113334|E1|Reported Event|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
557630|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557631|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557632|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557633|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557634|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557635|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557636|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557637|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557638|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557639|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557640|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557641|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557694|NCT00113490|B1|Baseline|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557642|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557643|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557644|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557645|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557646|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557647|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557648|NCT00113529|O1|Outcome|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557649|NCT00113529|E1|Reported Event|Sunitinib + Gefitinib|Phase 2 included 4 subjects from Phase 1 (37.5 mg or 50 mg sunitinib [administered on Cycle 1, Days 1, 9, 10, 20, 21, 28; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28] + 250 mg gefitinib [administered on Cycle 1, Days 10, 20, 21, 28, 42; Cycles 2 to 4, Days 1, 28; Cycles 5 plus, Days 1, 28]) and 31 from Phase 2 (37.5 mg sunitinib + 250 mg gefitinib [both administered on Cycle 1, Days 1, 14, 28; Cycles 2 to 4, Days 1, 28; Cycle 5 plus, Days 1, 28]), for a total of 35 subjects. A cycle = sunitinib given daily for 4 weeks followed by a 2-week off-treatment period.
557650|NCT00113516|B1|Baseline|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557651|NCT00113516|P2|Participant Flow|Sunitinib|Sunitinib 50 mg
557652|NCT00113516|P1|Participant Flow|Carboplatin Plus Paclitaxel|Carboplatin Plus Paclitaxel 172-225 mg/m2
557653|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557654|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557655|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557656|NCT00113516|O1|Outcome|First Carboplatin Plus Paclitaxel, Then Sunitinib|Part 1 = Carboplatin plus Paclitaxel 172-225 mg/m2. Part 2 = Sunitinib 50 mg
557657|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557658|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557659|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557660|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557661|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557662|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557663|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557664|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557665|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557666|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557667|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557668|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557669|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557670|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557671|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557672|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557673|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557674|NCT00113516|O1|Outcome|Sunitinib|Part 2 = Sunitinib 50 mg
557695|NCT00113490|P2|Participant Flow|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557696|NCT00113490|P1|Participant Flow|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557697|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557698|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557699|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557700|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557701|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557702|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557703|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557704|NCT00113490|O2|Outcome|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557705|NCT00113490|O1|Outcome|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557706|NCT00113490|E2|Reported Event|Palivizumab 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557707|NCT00113490|E1|Reported Event|Motavizumab (MEDI-524) 15 mg/kg|A single intramuscular injection every 30 days for a total of 4-5 injections determined by when in the RSV season a child was enrolled.
557708|NCT00113425|B1|Baseline|Treated Group Pulsed Dye Laser Therapy and Untreated Group|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face and the contralateral side of the face remained untreated, thus serving as an internal control.
557709|NCT00113425|P1|Participant Flow|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557710|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557711|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557712|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557713|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557714|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557715|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557716|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557717|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557718|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557719|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557720|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557721|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557722|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
557723|NCT00113425|O1|Outcome|All Study Participants|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face while the contralateral side of the face remained untreated, thus serving as an internal control.
571836|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
557725|NCT00113425|E1|Reported Event|Treated Group Pulsed Dye Laser Therapy|Patients were randomized to receive topical photosensitizer applications followed by pulsed dye laser therapy to one side of the face.
557726|NCT00113399|B3|Baseline|Total|Total of all reporting groups
557727|NCT00113399|B2|Baseline|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with on-study information, which is 7 patients.]"
557728|NCT00113399|B1|Baseline|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with on-study information, which is 6 patients.]
557729|NCT00113399|P2|Participant Flow|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
557730|NCT00113399|P1|Participant Flow|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
557731|NCT00113399|O2|Outcome|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel"
557732|NCT00113399|O1|Outcome|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8
557733|NCT00113399|E2|Reported Event|Chemotherapy Alone|"Select from one of the three standard chemotherapy regimens:~cisplatin/5-FU; cisplatin/paclitaxel; cisplatin/docetaxel. [Data is reported for eligible patients with adverse event information, which is 7 patients.]"
557734|NCT00113399|E1|Reported Event|Re-irradiation Plus Concurrent Chemotherapy|Radiation Therapy on weeks 1, 3, 5, and 7; 1.5 Gy/fx, twice daily x 5 days, 40 fractions, for a total dose of 60 Gy; Chemotherapy (cisplatin/paclitaxel) on weeks 1, 3, 5, and 7 G-CSF on weeks 2, 4, 6, and 8. [Data is reported for eligible patients with adverse event information, which is 6 patients.]
557735|NCT00113386|B3|Baseline|Total|Total of all reporting groups
557736|NCT00113386|B2|Baseline|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with on-study information, which is 7 patients.]
557737|NCT00113386|B1|Baseline|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery [Data is reported for eligible patients with on-study information, which is 8 patients.]
557738|NCT00113386|P2|Participant Flow|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative (induction) throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
557739|NCT00113386|P1|Participant Flow|Preoperative Cisplatin/Docetaxel|Preoperative (induction) cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
557740|NCT00113386|O2|Outcome|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery.
557741|NCT00113386|O1|Outcome|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery
557742|NCT00113386|E2|Reported Event|Preoperative Radiotherapy and Cisplatin/Docetaxel|Preoperative throacic radiation therapy 50.4 Gy concurrently with cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy and radiation therapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 7 patients.]
557743|NCT00113386|E1|Reported Event|Preoperative Cisplatin/Docetaxel|Preoperative cisplatin/docetaxel; surgical resection 4-8 weeks post-chemotherapy; docetaxel 4-6 weeks post-surgery. [Data is reported for eligible patients with adverse event information, which is 9 patients.]
557744|NCT00113373|B1|Baseline|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557745|NCT00113373|P1|Participant Flow|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557746|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557747|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557748|NCT00113373|O1|Outcome|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557749|NCT00113373|E1|Reported Event|Lapatinib|1500 mg of lapatinib orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
557750|NCT00113360|B1|Baseline|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
557751|NCT00113360|P1|Participant Flow|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
557752|NCT00113360|O1|Outcome|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
557753|NCT00113360|E1|Reported Event|RAD001 Plus Octreotide Depot|RAD001 at 5 or 10 milligrams orally once a day plus Octreotide Depot 30 milligrams intramuscularly once every 28 days
557754|NCT00113334|B1|Baseline|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
557755|NCT00113334|P1|Participant Flow|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
557756|NCT00113334|O1|Outcome|ABT-510 (Thrombospondin)|Fixed dose level of thrombospondin 100 mg subcutaneously twice daily.
571837|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
557761|NCT00113321|E1|Reported Event|Decitabine|20 mg/m2 by vein (IV) over 1 hour daily x 5 days.
557762|NCT00113295|B3|Baseline|Total|Total of all reporting groups
557763|NCT00113295|B2|Baseline|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557764|NCT00113295|B1|Baseline|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557765|NCT00113295|P2|Participant Flow|Placebo Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly titrated up to a maximum of 62.5 mg/day by week 10. Individuals who did not achieve remission and were randomized into the placebo group received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557766|NCT00113295|P1|Participant Flow|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|In the first phase of the study, individuals started at 12.5 mg/day of paroxetine and flexibly tirated up to a maximum of 62.5 mg/day by week 10. Individuals who did not receive remission and were randomized to receive quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557767|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557768|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
557769|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557770|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557771|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557772|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557773|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557774|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16(mean±SD endpoint dose=120.5±100.5 mg/day).
557775|NCT00113295|O2|Outcome|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557776|NCT00113295|O1|Outcome|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557777|NCT00113295|E3|Reported Event|Paroxetine|Individuals received paroxetine CR for 10 weeks in Phase 1 of the study, initiated at 12.5 mg and flexibly titrated up to a maximum of 62.5 mg/day by week 8.
557778|NCT00113295|E2|Reported Event|Placebo Augmentation of Continued Paroxetine|Individuals received placebo augmentation of continued paroxetine CR at the week 10 dose level.
557779|NCT00113295|E1|Reported Event|Quetiapine, 25-400mg/Day Augmentation of Continued Paroxetine|Individuals randomized to receive Quetiapine started at 25 mg at bedtime for the first week, then flexibly dosed based on response and tolerability to a maximum of 200 mg BID by week 16.
557780|NCT00113269|B5|Baseline|Total|Total of all reporting groups
557781|NCT00113269|B4|Baseline|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557782|NCT00113269|B3|Baseline|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557783|NCT00113269|B2|Baseline|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557784|NCT00113269|B1|Baseline|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557785|NCT00113269|P4|Participant Flow|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557786|NCT00113269|P3|Participant Flow|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557787|NCT00113269|P2|Participant Flow|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557788|NCT00113269|P1|Participant Flow|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557789|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557790|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557791|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
558216|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
557792|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557793|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557794|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557795|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557796|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557797|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557798|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557799|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557800|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557801|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557802|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557803|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557804|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557805|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557806|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557807|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557808|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557809|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557810|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557811|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557812|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557813|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557814|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557815|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557816|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557817|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557818|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557819|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557820|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557821|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557822|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557823|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
571838|NCT00063635|O3|Outcome|Placebo|Matching placebo
557824|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557825|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557826|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557827|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557828|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557829|NCT00113269|O4|Outcome|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557830|NCT00113269|O3|Outcome|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557831|NCT00113269|O2|Outcome|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557832|NCT00113269|O1|Outcome|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557833|NCT00113269|E4|Reported Event|Conventional Low-Risk Patients|Basiliximab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557834|NCT00113269|E3|Reported Event|Alemtuzumab Low- Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; Low risk patients: Panel reactive antibody < 20% and first transplant and non-African American
557835|NCT00113269|E2|Reported Event|Conventional High-Risk Patients|Rabbit anti-thymocyte globulin, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557836|NCT00113269|E1|Reported Event|Alemtuzumab High-Risk Patients|Alemtuzumab, tacrolimus, mycophenolate mofetil and steroids; High risk patients: Panel reactive antibody ≥ 20% or re-transplant or African American
557837|NCT00113230|B1|Baseline|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
557838|NCT00113230|P1|Participant Flow|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
557839|NCT00113230|O1|Outcome|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
557840|NCT00113230|E1|Reported Event|Avastin|Neoadjuvant therapy with radiotherapy (50.4 Gy in 28 fractions over 5.5 weeks), Avastin every 2 weeks (3 doses of 5 mg/kg), and capecitabine (900 mg/m2 orally twice daily only on days of radiation) followed by surgical resection.
557841|NCT00113217|B1|Baseline|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
557842|NCT00113217|P1|Participant Flow|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
557843|NCT00113217|O1|Outcome|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
557844|NCT00113217|E1|Reported Event|Bevacizumab|10 mg/kg intravenous (IV) Day 1 of 14-day cycle.
557845|NCT00113087|B3|Baseline|Total|Total of all reporting groups
557846|NCT00113087|B2|Baseline|Placebo|Placebo suspension
557847|NCT00113087|B1|Baseline|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557848|NCT00113087|P2|Participant Flow|Placebo|Placebo suspension
557849|NCT00113087|P1|Participant Flow|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557850|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557851|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557852|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557853|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557854|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557855|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557856|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557857|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557858|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557859|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557860|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557861|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557862|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557863|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557864|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557865|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557866|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557867|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557868|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557869|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557870|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557871|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557872|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557873|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557874|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557875|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557876|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557877|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557878|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557879|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557880|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557881|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557882|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557883|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557884|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557885|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557886|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557887|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557888|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557889|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557890|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557891|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557892|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557893|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557894|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557895|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557896|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557897|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557898|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557899|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557900|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557901|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557902|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557903|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557904|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557905|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557906|NCT00113087|O2|Outcome|Placebo|Placebo suspension
557907|NCT00113087|O1|Outcome|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557908|NCT00113087|E2|Reported Event|Placebo|Placebo suspension
557909|NCT00113087|E1|Reported Event|Enalapril|ACE (Angiotensin-converting enzyme) inhibitor enalapril, initial dose 0.1 mg/kg/day; Uptitrated as tolerated to target dose of 0.4 mg/kg/day given in two divided doses
557910|NCT00112918|B4|Baseline|Total|Total of all reporting groups
557957|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557911|NCT00112918|B3|Baseline|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557912|NCT00112918|B2|Baseline|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557913|NCT00112918|B1|Baseline|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557914|NCT00112918|P3|Participant Flow|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557915|NCT00112918|P2|Participant Flow|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557916|NCT00112918|P1|Participant Flow|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-fluorouracil (5-FU), given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557917|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557918|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557919|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557920|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557921|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557922|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557923|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557924|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557925|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557926|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557927|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557928|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557929|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557930|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
558217|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
557931|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557932|NCT00112918|O3|Outcome|XELOX+Bv|"Weeks 1-24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557933|NCT00112918|O2|Outcome|FOLFOX4 + Bv|"Weeks 1-24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 - 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557934|NCT00112918|O1|Outcome|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557935|NCT00112918|E3|Reported Event|XELOX+Bv|"Weeks 1–24: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin administered as a 130 mg/m^2 intravenous infusion over 2 hours (day 1 every 3 weeks) in combination with capecitabine, which was administered orally at a dose of 1000 mg/m^2 twice daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of day 1 and last dose the morning of day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment), for a total of 8 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557936|NCT00112918|E2|Reported Event|FOLFOX4 + Bv|"Weeks 1–24: Bevacizumab 5 mg/kg was administered as an intravenous infusion over 30 – 90 minutes followed by oxaliplatin, administered as an 85 mg/m^2 intravenous infusion over 2 hours (on day 1 only) concomitantly with leucovorin, as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion are repeated on day 2. Cycle length is 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25–48: Bevacizumab 7.5 mg/kg was administered as an intravenous infusion over 30 minutes. Cycle length was 3 weeks. Cycles were repeated every 3 weeks for a total of 8 cycles (24 weeks)."
557937|NCT00112918|E1|Reported Event|FOLFOX4|"Weeks 1-24: Oxaliplatin was administered as an 85 mg/m^2 intravenous infusion over 2 hours concomitantly with Leucovorin as a 200 mg/m^2 infusion over 2 hours, followed by 5-FU, given as a 400 mg/m^2 bolus injection, and then as a 600 mg/m^2 continuous infusion over 22 hours. Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection, and 5-FU 600 mg/m^2 continuous infusion were repeated on day 2. Cycle length was 2 weeks and cycles were repeated every second week for a total of 12 cycles (24 weeks).~Weeks 25-48: Observation only."
557938|NCT00112905|B1|Baseline|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
557939|NCT00112905|P1|Participant Flow|TCC (Transitional Cell Carcinoma) Cohort|Sorafenib was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If sorafenib was taken with meals, patients were instructed to take sorafenib tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies. Patients were instructed to keep a pill diary and record the pills they took each day.
557940|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
557941|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
558019|NCT00112489|E1|Reported Event|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
557942|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
557943|NCT00112905|O1|Outcome|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
557944|NCT00112905|E1|Reported Event|TCC Cohort|"Only eligible and treated patients are included in the analysis.~BAY 43-9006 was administered at a dose of 400 mg orally twice daily (total daily dose 800 mg) for eight weeks as one cycle. Patients swallowed the tablets whole with approximately 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly), with or without food. If Bay 43-9006 was taken with meals, patients were instructed to take BAY 43-9006 tosylate with a moderate to low-fat meal, as a high fat meal caused a decrease in absorption in previous studies."
557945|NCT00112840|B4|Baseline|Total|Total of all reporting groups
557946|NCT00112840|B3|Baseline|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557947|NCT00112840|B2|Baseline|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557948|NCT00112840|B1|Baseline|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557949|NCT00112840|P3|Participant Flow|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557950|NCT00112840|P2|Participant Flow|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1= 10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557951|NCT00112840|P1|Participant Flow|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557952|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557953|NCT00112840|O2|Outcome|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557954|NCT00112840|O1|Outcome|Phase 1, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557955|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557956|NCT00112840|O1|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
558020|NCT00112437|B6|Baseline|Total|Total of all reporting groups
558021|NCT00112437|B5|Baseline|MK0822 50 mg|50 mg MK0822 1 tablet once a week
557958|NCT00112840|O2|Outcome|Phase 1, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557959|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and escalating doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557960|NCT00112840|O3|Outcome|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557961|NCT00112840|O2|Outcome|Phase 1 , Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557962|NCT00112840|O1|Outcome|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 in escalating dose levels to determine Maximum Tolerated Dose (MTD). In the phase I portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and doses of IV Bevacizumab (level 1=5mg/kg; level 2=10 mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. The first three patients began at dose level 1 and cohort doses escalate until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557963|NCT00112840|E3|Reported Event|Phase II|Phase II patients were treated at the highest dose level (dose level 2: CCI-779 25 mg IV weekly and Bevacizumab 10 mg/kg IV every two weeks). Patients receive 25 mg CCI-779 IV on days 1, 8, 15, and 22 and 10 mg/kg bevacizumab IV on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 3 years after study entry.
557964|NCT00112840|E2|Reported Event|Phase I, Dose Level 2|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 2 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557965|NCT00112840|E1|Reported Event|Phase I, Dose Level 1|Patients receive CCI-779 IV on days 1, 8, 15, and 22 and bevacizumab IV on days 1 and 15 In the Phase 1, Dose Level 1 portion, cohorts of 3-6 eligible patients were treated with CCI-779 (25 mg IV weekly) and IV Bevacizumab (level 1=5mg/kg) every other week. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
557966|NCT00112736|B4|Baseline|Total|Total of all reporting groups
557967|NCT00112736|B3|Baseline|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
557968|NCT00112736|B2|Baseline|Phase II n=16|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Anaplastic Glioma~erlotinib: Given orally~temsirolimus: Given IV"
557969|NCT00112736|B1|Baseline|Phase I n=9|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
557970|NCT00112736|P2|Participant Flow|Phase II (Erlotinib & Temsirolimus)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
557971|NCT00112736|P1|Participant Flow|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
557972|NCT00112736|O1|Outcome|Phase II n=43|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~Glioblastoma~erlotinib: Given orally~temsirolimus: Given IV"
557973|NCT00112736|O3|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
557974|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
557975|NCT00112736|O1|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
558022|NCT00112437|B4|Baseline|MK0822 25 mg|25 mg MK0822 1 tablet once a week
557976|NCT00112736|O1|Outcome|Phase I 15mg Temsirolimus (MTD Dose)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV"
557977|NCT00112736|O3|Outcome|Phase 1 - 15mg|PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (15mg). Every 28 days until disease progression or unacceptable toxicity.
557978|NCT00112736|O2|Outcome|Phase 1 - 25 mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (25mg). Every 28 days until disease progression or unacceptable toxicity.
557979|NCT00112736|O1|Outcome|Phase 1 - 50mg|Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (50mg). Every 28 days until disease progression or unacceptable toxicity.
557980|NCT00112736|O1|Outcome|Phase I - Dose Escalation|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at (dose escalation or dose de-escalation). Every 28 days until disease progression or unacceptable toxicity.~Dose levels: cohort 1 - 50mg - 3pts cohort 2 - 25mg -6pt cohort 3 - 15mg - 12pts"
557981|NCT00112736|E2|Reported Event|Phase II (Erlotinib & Erlotinib)|"Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 at MTD phse I. Every 28 days until disease progression or unacceptable toxicity.~PHASE II (preoperative component): Patients who are surgical candidates may opt to undergo surgical resection of the tumor. Beginning 5-7 days before surgery, these patients receive oral erlotinib once daily until surgery. Patients also receive temsirolimus IV over 30 minutes at the MTD and then undergo surgical resection of the tumor 3-24 hours later. Beginning 2-4 weeks after surgery, patients receive temsirolimus at the MTD and erlotinib as in phase I.~therapeutic conventional surgery: Undergo surgical resection~laboratory biomarker analysis: Correlative studies"
557982|NCT00112736|E1|Reported Event|Phase I (Erlotinib & Temsirolimus)|"PHASE I: Oral erlotinib 1 daily days 1-28 (150mg), temsirolimus IV 30 minutes days 1, 8, 15, 22 (dose escalation). Every 28 days until disease progression or unacceptable toxicity.~erlotinib: Given orally~temsirolimus: Given IV~pharmacological study: Correlative studies"
557983|NCT00112723|B1|Baseline|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
557984|NCT00112723|P3|Participant Flow|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557985|NCT00112723|P2|Participant Flow|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557986|NCT00112723|P1|Participant Flow|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557987|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
557988|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557989|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557990|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
557991|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
557992|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
557993|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
557994|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
557995|NCT00112723|O1|Outcome|All Dose Levels of Alvocidib|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
557996|NCT00112723|O3|Outcome|Cohort 4|Patients diagnosed with T Cell NHL
557997|NCT00112723|O2|Outcome|Cohort 2|Patients diagnosed with Mantle Cell NHL
557998|NCT00112723|O1|Outcome|Cohort 1|Patients diagnosed with Indolent B-cell NHL
558023|NCT00112437|B3|Baseline|MK0822 10 mg|10 mg MK0822 1 tablet once a week
557999|NCT00112723|O1|Outcome|Dose Levels 1, 2, 3|"Dose Level 1 (30 mg/m2 + 30 mg/m2), Dose Level 2 (30 mg/m2 + 50 mg/m2), Dose Level 3 (50 mg/m2 + 50 mg/m2)~PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
558000|NCT00112723|O3|Outcome|Dose Level 3 Dose (Flavopiridol 50 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
558001|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
558002|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.
558003|NCT00112723|O3|Outcome|Level 3 (50+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
558004|NCT00112723|O2|Outcome|Level 2 (30+50)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
558005|NCT00112723|O1|Outcome|Dose Level 1 (30+30)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
558006|NCT00112723|O3|Outcome|Dose Level 3 (Flavopiridol 50 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
558007|NCT00112723|O2|Outcome|Dose Level 2 (Flavopiridol 30 mg/m2 + 50 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
558008|NCT00112723|O1|Outcome|Dose Level 1 (Flavopiridol 30 mg/m2 + 30 mg/m2)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I."
558009|NCT00112723|E1|Reported Event|Treatment (Alvocidib)|"PHASE I: Patients receive flavopiridol IV over 4½ hours on days 1, 8, 15, and 22. Treatment repeats every 6 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of flavopiridol until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity.~PHASE II: Patients receive flavopiridol* as in phase I at the MTD determined in phase I.~alvocidib: Given IV"
558010|NCT00112671|B1|Baseline|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558011|NCT00112671|P1|Participant Flow|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558012|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558013|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558014|NCT00112671|O1|Outcome|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558015|NCT00112671|E1|Reported Event|Treatment (Sorafenib Tosylate)|"Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~sorafenib tosylate: Given orally~laboratory biomarker analysis: Correlative studies"
558016|NCT00112489|B1|Baseline|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
558017|NCT00112489|P1|Participant Flow|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
558018|NCT00112489|O1|Outcome|Paclitaxel Followed by Carboplatin|Paclitaxel 175 mg/m2 IV over 3 hours followed by Carboplatin AUC = 6 IV over 30 minutes repeated every 21 days until disease progression or adverse effects prohibit further therapy
558024|NCT00112437|B2|Baseline|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558025|NCT00112437|B1|Baseline|Placebo|Placebo 1 tablet once a week
558026|NCT00112437|P15|Participant Flow|MK0822 50 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table~during 3 years."
558027|NCT00112437|P14|Participant Flow|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558028|NCT00112437|P13|Participant Flow|MK0822 25 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
558029|NCT00112437|P12|Participant Flow|MK0822 25 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year."
558030|NCT00112437|P11|Participant Flow|MK0822 10 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year."
558031|NCT00112437|P10|Participant Flow|MK0822 10 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg~tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year."
558032|NCT00112437|P9|Participant Flow|MK0822 3 mg / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year."
558033|NCT00112437|P8|Participant Flow|MK0822 3 mg / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year."
558034|NCT00112437|P7|Participant Flow|Placebo / MK0822 50 mg|"12 Month Extension (Year 3)~During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year."
558035|NCT00112437|P6|Participant Flow|Placebo / Placebo|"12 Month Extension (Year 3)~During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years."
558036|NCT00112437|P5|Participant Flow|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558037|NCT00112437|P4|Participant Flow|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558038|NCT00112437|P3|Participant Flow|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558039|NCT00112437|P2|Participant Flow|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558040|NCT00112437|P1|Participant Flow|Placebo|Placebo 1 tablet once a week.
558041|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558042|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558043|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558044|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558045|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558046|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558047|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558048|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558049|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558050|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558218|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558051|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558052|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558053|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558054|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558055|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558056|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558057|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558058|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558059|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558060|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558061|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558062|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558063|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558064|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558065|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558066|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558067|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558068|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558069|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558070|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558071|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558072|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558219|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558073|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558074|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558075|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558076|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558077|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558078|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558079|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558080|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558081|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558082|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558083|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558084|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558085|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558086|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558087|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558088|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558089|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558090|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558091|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558092|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558093|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558094|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558220|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558095|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558096|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558097|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558098|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558099|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558100|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558101|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558102|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558103|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558104|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558105|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558106|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558107|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558108|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558109|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558110|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558111|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558112|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558113|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558114|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558115|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558116|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
571839|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
558117|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558118|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558119|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558120|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558121|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558122|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558123|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558124|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558125|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558126|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558127|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558128|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558129|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558130|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558131|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558132|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558133|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558134|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558135|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558136|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558137|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558160|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558138|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558139|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558140|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558141|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558142|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558143|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558144|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558145|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558146|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558147|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558148|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558149|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558150|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558151|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558152|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558153|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558154|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558155|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558156|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558157|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558158|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558159|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558161|NCT00112437|O10|Outcome|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558162|NCT00112437|O9|Outcome|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558163|NCT00112437|O8|Outcome|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558164|NCT00112437|O7|Outcome|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558165|NCT00112437|O6|Outcome|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558166|NCT00112437|O5|Outcome|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558167|NCT00112437|O4|Outcome|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558168|NCT00112437|O3|Outcome|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558169|NCT00112437|O2|Outcome|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558170|NCT00112437|O1|Outcome|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558171|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558172|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558173|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558174|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558175|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558176|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558177|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558178|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558179|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558180|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558181|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558182|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558183|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558184|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558185|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558186|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558187|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558188|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558189|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558190|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558191|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558192|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558193|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558194|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558195|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558196|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558197|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558198|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558199|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558200|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558201|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558202|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558203|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558204|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558205|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558206|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558207|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558208|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558209|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558210|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558211|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558212|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558213|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558221|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558222|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558223|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558224|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558225|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558226|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558227|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558228|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558229|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558230|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558231|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558232|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558233|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558234|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558235|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558236|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558237|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558238|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558239|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558240|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558241|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558242|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558243|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558244|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558245|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558246|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558247|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558248|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558249|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558250|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558251|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558252|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558253|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558254|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558255|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558256|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558257|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558258|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558259|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558260|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558261|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558262|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558263|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558264|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558265|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558266|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558267|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558268|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558269|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558270|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558271|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558272|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558273|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558274|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558275|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558276|NCT00112437|O5|Outcome|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558277|NCT00112437|O4|Outcome|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558278|NCT00112437|O3|Outcome|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558279|NCT00112437|O2|Outcome|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558280|NCT00112437|O1|Outcome|Placebo|Placebo 1 tablet once a week
558281|NCT00112437|E15|Reported Event|MK0822 50 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 50 mg table during 3 years.
558282|NCT00112437|E14|Reported Event|MK0822 50 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 50 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558283|NCT00112437|E13|Reported Event|MK0822 25 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822 once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558284|NCT00112437|E12|Reported Event|MK0822 25 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 25 mg tablet of MK0822 once a week during 2 years and one placebo tablet once a week during the 3rd year.
558285|NCT00112437|E11|Reported Event|MK0822 10 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one 50 mg tablet of MK0822 once a week during the 3rd year.
558332|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558286|NCT00112437|E10|Reported Event|MK0822 10 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Patients in this treatment group took one 10 mg tablet of MK0822 once a week during 2 years and one placebo tablet during the 3rd year.
558287|NCT00112437|E9|Reported Event|MK0822 3 mg / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet, of MK0822, once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week during 2 years. These patients have been on 3 mg of MK0822 for two years and 50 mg of MK0822 during the 3rd year.
558288|NCT00112437|E8|Reported Event|MK0822 3 mg / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one 3 mg tablet of MK0822 once a week for 2 years. These patients have been on 3 mg of MK0822 for 2 years and placebo during the 3rd year.
558289|NCT00112437|E7|Reported Event|Placebo / MK0822 50 mg|12 Month Extension (Year 3) During this 12 month extension patients took one 50 mg tablet of MK0822, once a week. Before entering this extension patients in this treatment group took Placebo for 2 years. These patients have been on placebo for 2 years and 50 mg of MK0822 during the 3rd year.
558290|NCT00112437|E6|Reported Event|Placebo / Placebo|12 Month Extension (Year 3) During this 12 month extension patients in this treatment group took one placebo tablet once a week. Before entering this extension patients in this treatment group took one placebo tablet once a week for 2 years. These patients have been on placebo for 3 years.
558291|NCT00112437|E5|Reported Event|MK0822 50 mg|50 mg MK0822 1 tablet once a week
558292|NCT00112437|E4|Reported Event|MK0822 25 mg|25 mg MK0822 1 tablet once a week
558293|NCT00112437|E3|Reported Event|MK0822 10 mg|10 mg MK0822 1 tablet once a week
558294|NCT00112437|E2|Reported Event|MK0822 3 mg|3 mg MK0822 1 tablet once a week
558295|NCT00112437|E1|Reported Event|Placebo|Placebo 1 tablet once a week
558296|NCT00112385|B3|Baseline|Total|Total of all reporting groups
558297|NCT00112385|B2|Baseline|Placebo|Subjects will be given syringes containing placebo
558298|NCT00112385|B1|Baseline|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558299|NCT00112385|P2|Participant Flow|Placebo|Subjects will be given syringes containing placebo
558300|NCT00112385|P1|Participant Flow|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558301|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558302|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558303|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558304|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558305|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558306|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558307|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558308|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558309|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558310|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558311|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558312|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558313|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558314|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558315|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558316|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558317|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558318|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558319|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558320|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558321|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558322|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558323|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558324|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558325|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558326|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558327|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558328|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558329|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558330|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558331|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558333|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558334|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558335|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558336|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558337|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558338|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558339|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558340|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558341|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558342|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558343|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558344|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558345|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558346|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558347|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558348|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558349|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558350|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558351|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558352|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558353|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558354|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558355|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558356|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558357|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558358|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558359|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558360|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558361|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558362|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558363|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558364|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558365|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558366|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558367|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558368|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558369|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558370|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558371|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558372|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558373|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558374|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558375|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558376|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558377|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558378|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558379|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558380|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558381|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558382|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558383|NCT00112385|O2|Outcome|Placebo|Subjects will be given syringes containing placebo
558384|NCT00112385|O1|Outcome|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558385|NCT00112385|E2|Reported Event|Placebo|Subjects will be given syringes containing placebo
558386|NCT00112385|E1|Reported Event|Etanercept|Subjects randomized to Etanercept will be provided with syringes contain 50 mg and will be injected SQ once a week for 52 wks
558387|NCT00112359|B3|Baseline|Total|Total of all reporting groups
558388|NCT00112359|B2|Baseline|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558389|NCT00112359|B1|Baseline|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558390|NCT00112359|P2|Participant Flow|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558391|NCT00112359|P1|Participant Flow|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558392|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558393|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558394|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558395|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558396|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558397|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558398|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558399|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558400|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558401|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558402|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558403|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558404|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558405|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558406|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558407|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558408|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558409|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558410|NCT00112359|O2|Outcome|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558411|NCT00112359|O1|Outcome|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558479|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558481|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
558412|NCT00112359|E2|Reported Event|75 mg AZLI TID|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation three times a day using the investigational nebulizer.
558413|NCT00112359|E1|Reported Event|Placebo TID|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered three times a day by inhalation using the investigational nebulizer.
558414|NCT00112294|B3|Baseline|Total|Total of all reporting groups
558415|NCT00112294|B2|Baseline|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558416|NCT00112294|B1|Baseline|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558417|NCT00112294|P2|Participant Flow|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558418|NCT00112294|P1|Participant Flow|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558419|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558420|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558421|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558422|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558423|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558424|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558425|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558426|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558427|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558428|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558429|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558430|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558431|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558432|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558433|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558434|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558435|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558436|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558437|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558438|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558439|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558440|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558441|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558442|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558443|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558444|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558445|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558480|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
558446|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558447|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558448|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558449|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558450|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558451|NCT00112294|O2|Outcome|Taxane+Carboplatin (T/C)|A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558452|NCT00112294|O1|Outcome|Cetuximab+Taxane+Carboplatin (C/T/C)|Cetuximab was administered at an initial dose (Week 1) of 400 mg/m^2 IV infusion (infused over 120 minutes) and a weekly maintenance dose of 250 mg/m^2 IV infusion (infused over 60 minutes). A cycle of therapy was defined as 3 weeks. Taxane was paclitaxel 225 mg/m^2 infused over 180 minutes on Day 1 and subsequently every 3 weeks or docetaxel 75 mg/m^2 infused over 60 minutes on Day 1 and subsequently every 3 weeks. Carboplatin was infused over 30 minutes on Day 1 and subsequently every 3 weeks.
558453|NCT00112294|E2|Reported Event|Taxane+Carboplatin|
558454|NCT00112294|E1|Reported Event|Cetuximab+Taxane+Carboplatin|
558455|NCT00112151|B7|Baseline|Total|Total of all reporting groups
558456|NCT00112151|B6|Baseline|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
558457|NCT00112151|B5|Baseline|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
558458|NCT00112151|B4|Baseline|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
558459|NCT00112151|B3|Baseline|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
558460|NCT00112151|B2|Baseline|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
558461|NCT00112151|B1|Baseline|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
558462|NCT00112151|P6|Participant Flow|Placebo+No Resistance Training|"Placebo group applies two 2.5 gm placebo packets~No exercise program"
558463|NCT00112151|P5|Participant Flow|Placebo+Resistance Training|"Placebo Group applies two 2.5 gm placebo packets~1 year standard Progressive Resistance Training(PRT) program"
558464|NCT00112151|P4|Participant Flow|HighT+No Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~No exercise program"
558465|NCT00112151|P3|Participant Flow|HighT+Resistance Training|"High Dose Testosterone Group applies two 2.5 gm active packets, titrated to a target blood range of 600-1000 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
558466|NCT00112151|P2|Participant Flow|LowT+No Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~No exercise program"
558467|NCT00112151|P1|Participant Flow|LowT+Resistance Training|"Low Dose Testosterone Group applies one 2.5 gm active packet and one placebo packet, titrated to a target blood range of 400-550 pg/ml)~1 year standard Progressive Resistance Training(PRT) program"
558468|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
558469|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
558470|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558471|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558472|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
558473|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
558474|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558475|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558476|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
558477|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
558478|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558482|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558483|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558484|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower- or higher-range) plus progressive resistance training
558485|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower- or higher-range); no exercise
558486|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558487|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558488|NCT00112151|O4|Outcome|Any T + PRT|T gel supplementation (lower or higher-range) plus progressive resistance training
558489|NCT00112151|O3|Outcome|Any T + No PRT|T gel supplementation (lower or higher-range); no exercise
558490|NCT00112151|O2|Outcome|Placebo + PRT|Placebo gel plus progressive resistance training
558491|NCT00112151|O1|Outcome|Placebo + No PRT|Placebo gel; no exercise
558492|NCT00112151|E3|Reported Event|Higher-range T|T gel supplementation targeting a total serum T concentration of 600-1000ng/dL, with our without progressive resistance training
558493|NCT00112151|E2|Reported Event|Lower-range T|T gel supplementation targeting a total serum T concentration of 400-550ng/dL, with our without progressive resistance training
558494|NCT00112151|E1|Reported Event|Placebo|Placebo gel with or without progressive resistance training
558495|NCT00112112|B3|Baseline|Total|Total of all reporting groups
558496|NCT00112112|B2|Baseline|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558497|NCT00112112|B1|Baseline|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558498|NCT00112112|P2|Participant Flow|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558499|NCT00112112|P1|Participant Flow|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558500|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558501|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558502|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558503|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558504|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558505|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558506|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558507|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558508|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558509|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558510|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558511|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558512|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558513|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558763|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558514|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558515|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558516|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558517|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558518|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558519|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558520|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558521|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558522|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558523|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558524|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558525|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558526|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558527|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558528|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558529|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558530|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558531|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558532|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558533|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558534|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558535|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558536|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558537|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
571840|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
558538|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558539|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558540|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558541|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558542|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558543|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558544|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558545|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558546|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558547|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558548|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558549|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558550|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558551|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558552|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558553|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558554|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558555|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558556|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558557|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558558|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558559|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558560|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558561|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
571841|NCT00063635|O3|Outcome|Placebo|Matching placebo
558562|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558563|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558564|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558565|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558566|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558567|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558568|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558569|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558570|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558571|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558572|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558573|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558574|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558575|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558576|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558577|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558578|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558579|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558580|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558581|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558582|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558583|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558584|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558585|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
571842|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
558586|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558587|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558588|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558589|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558590|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558591|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558592|NCT00112112|O2|Outcome|Placebo|Placebo intranasal mist was composed of allantoic fluid stabilized with buffer containing sucrose, potassium phosphate, and monosodium glutamate. The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril).
558593|NCT00112112|O1|Outcome|FluMist|The total volume of 0.5 mL was administered intranasally with a spray applicator (approximately 0.25 mL into each nostril). Each dose contained approximately 10 to 7th TCID 50 (median tissue culture infectious dose) of each of three influenza virus strains.
558594|NCT00112112|E2|Reported Event|FluMist|
558595|NCT00112112|E1|Reported Event|Placebo|
558596|NCT00112047|B3|Baseline|Total|Total of all reporting groups
558597|NCT00112047|B2|Baseline|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558598|NCT00112047|B1|Baseline|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558599|NCT00112047|P2|Participant Flow|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558600|NCT00112047|P1|Participant Flow|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558601|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558602|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558720|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558603|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558604|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558605|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558606|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558607|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558608|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558609|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558610|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558611|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558612|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558613|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558614|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558615|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558721|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558764|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558616|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558617|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558618|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558619|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558620|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558621|NCT00112047|O2|Outcome|All Atripla (From Atripla Baseline)|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558622|NCT00112047|O1|Outcome|EFV+FTC+TDF/Atripla (From Study Baseline)|Participants in this group were originally randomized to receive the 3 component drugs: efavirenz (EFV) + emtricitabine (FTC) + tenofovir disoproxil fumarate (tenofovir DF; TDF) for 96 weeks, and subsequently received Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF) and EFV until Week 144. Participants then rolled over into the further 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558623|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558624|NCT00112047|O1|Outcome|All Atripla|Participants rolled over into the 96-week study extension and received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks (Year 6) or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study.
558625|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558626|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558722|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558627|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558628|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558629|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558630|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558631|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558632|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558633|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558634|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558723|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558754|NCT00111761|P1|Participant Flow|Panitumumab With FOLFIRI|Panitumumab (2.5 mg/kg once weekly until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558635|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558636|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558637|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558638|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558639|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558640|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558641|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558642|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558724|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558755|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559152|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
558643|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558644|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558645|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558646|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558647|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558648|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558649|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558650|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558725|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558756|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559053|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
558651|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558652|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558653|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558654|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558655|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558656|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558657|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558658|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558726|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558757|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559054|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
558659|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558660|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558661|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558662|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558663|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558664|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558665|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558666|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558727|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558758|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559055|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
558667|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558668|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558669|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558670|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558671|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558672|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558673|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558674|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558728|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558759|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559153|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
558675|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558676|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558677|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558678|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558679|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558680|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558681|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558682|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558729|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558760|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
559056|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
558683|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558684|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558685|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558686|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558687|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558688|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558689|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558690|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558730|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558761|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
559057|NCT00110357|O1|Outcome|Number of Participants|
558691|NCT00112047|O2|Outcome|CBV+EFV|"Participants in this group received EFV 600 mg once daily + Combivir ([CBV]; the fixed dose combination pill containing lamivudine + zidovudine [150 mg/300 mg]) twice daily from the start of the study until Week 144. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated CNS toxicity.~At Week 144 all participants who opted to roll over into the additional 96-week study extension received ATR until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558692|NCT00112047|O1|Outcome|EFV+FTC+TDF|"Participants in this group received 3 component drugs: efavirenz (EFV) 600 mg + emtricitabine (FTC) 200 mg + tenofovir disoproxil fumarate (tenofovir DF; TDF) 300 mg, each once daily, from the start of the study. At 96 weeks Truvada ([TVD] the fixed-dose combination pill containing FTC/TDF (200 mg/300 mg) replaced FTC + TDF; participants continued to receive EFV as before. Nevirapine 200 mg twice daily could replace EFV in the event of efavirenz-associated central nervous system (CNS) toxicity.~At Week 144 all participants who opted to roll over into the further 96-week study extension received Atripla ([ATR]; the fixed dose combination pill containing EFV/FTC/TDF, 600 mg/200 mg/300 mg) until the end of the study (Week 240). At sites in France, the study was extended by a further 48 weeks or until ATR became commercially available (whichever happened first); once ATR became commercially available in France participants were not required to complete the full 288 weeks of the study."
558693|NCT00112047|E4|Reported Event|All Atripla (Week 144 to 240)|Exposure for all participants from both treatment groups who switched to ATR at Week 144 and continued treatment to Week 240 was up to 96 weeks. Exposure to ATR for 6 participants at sites in France was up to 144 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=286.
558694|NCT00112047|E3|Reported Event|CBV+EFV (Baseline to 144 Weeks)|Exposure to CBV+EFV during the randomized treatment phase was up to 144 weeks. For this safety population, N=254.
558695|NCT00112047|E2|Reported Event|FTC+TDF+EFV/ATR (Baseline to 240 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase and during the Atripla treatment phase was up to 240 weeks (TVD replaced FTC+TDF at Week 96; ATR replaced TVD+EFV at Week 144). Exposure to ATR for 6 participants at sites in France was up to 288 weeks (this was due to a protocol amendment which allowed these participants to continue to receive ATR until it became commercially available). For this safety population, N=160.
558696|NCT00112047|E1|Reported Event|FTC+TDF+EFV (Baseline to 144 Weeks)|Exposure to the component drugs EFV+FTC+TDF during the randomized treatment phase was up to 144 weeks (TVD replaced FTC+TDF from Week 96). For this safety population, N=257.
558697|NCT00111917|B3|Baseline|Total|Total of all reporting groups
558698|NCT00111917|B2|Baseline|Control|CBD placed on placebo
558699|NCT00111917|B1|Baseline|Infliximab|patients who will be placed on infliximab and controls who will get placebo
558700|NCT00111917|P2|Participant Flow|Group 2 - Placebo|This group was given a placebo infusion
558701|NCT00111917|P1|Participant Flow|Group 1 - Infliximab|This group was given an infusion of inliximab
558702|NCT00111917|O2|Outcome|Group 2|Placebo received
558703|NCT00111917|O1|Outcome|Group 1|Infliximab
558704|NCT00111917|O2|Outcome|Placebo|Placebo received
558705|NCT00111917|O1|Outcome|Infliximab|Infliximab received
558706|NCT00111917|O2|Outcome|Placebo|Placebo infusion
558707|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
558708|NCT00111917|O2|Outcome|Placebo|Placebo infusion
558709|NCT00111917|O1|Outcome|Infliximab|Infliximab infusion
558710|NCT00111917|E2|Reported Event|Group 2 - Placebo|Placebo infusion received
558711|NCT00111917|E1|Reported Event|Group 1 - Infliximab|Infliximab infusion received
558712|NCT00111813|B1|Baseline|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
558713|NCT00111813|P6|Participant Flow|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558714|NCT00111813|P5|Participant Flow|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558715|NCT00111813|P4|Participant Flow|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558716|NCT00111813|P3|Participant Flow|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558717|NCT00111813|P2|Participant Flow|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558718|NCT00111813|P1|Participant Flow|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558719|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
559058|NCT00110357|O2|Outcome|Non-CNS Primary Tumor|
558731|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558732|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558733|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558734|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558735|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558736|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558737|NCT00111813|O6|Outcome|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558738|NCT00111813|O5|Outcome|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558739|NCT00111813|O4|Outcome|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558740|NCT00111813|O3|Outcome|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558741|NCT00111813|O2|Outcome|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558742|NCT00111813|O1|Outcome|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558743|NCT00111813|O1|Outcome|All Participants|"Vorinostat capsules given 200 mg b.i.d., 300 mg q.d., or 400 mg q.d. Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib 0.7 mg/m^2, 0.9 mg/m^2, 1.1 mg/m^2, or 1.3 mg/m^2 twice weekly on Days 1, 4, 8, and 11 or on Days 4, 8, 11, and 15 of each cycle, depending on dose level."
558744|NCT00111813|E6|Reported Event|Vorinostat 400 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558745|NCT00111813|E5|Reported Event|Vorinostat 400 mg + Bortezomib 1.1 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558746|NCT00111813|E4|Reported Event|Vorinostat 400 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given q.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558747|NCT00111813|E3|Reported Event|Vorinostat 300 mg + Bortezomib 1.3 mg/m^2|"Vorinostat capsules given once daily (q.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 1, 4, 8, and 11 of each cycle)."
558748|NCT00111813|E2|Reported Event|Vorinostat 200 mg + Bortezomib 0.9 mg/m^2|"Vorinostat capsules given b.i.d. Treatment in 21 day cycles~(participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558749|NCT00111813|E1|Reported Event|Vorinostat 200 mg + Bortezomib 0.7 mg/m^2|"Vorinostat capsules given twice daily (b.i.d.). Treatment in 21 day cycles (participants received vorinostat for 14 days followed by a 7 day break).~Bortezomib injection. Treatment in 21 day cycles (participants received bortezomib on Days 4, 8, 11, and 15 of each cycle)."
558750|NCT00111761|B3|Baseline|Total|Total of all reporting groups
558751|NCT00111761|B2|Baseline|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558752|NCT00111761|B1|Baseline|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
558753|NCT00111761|P2|Participant Flow|Panitumumab With IFL|Panitumumab (2.5 mg/kg once weekly for up to 48 weeks or until disease progression, intolerable adverse event or other reason for discontinuation) in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
558762|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
558765|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558766|NCT00111761|O1|Outcome|Panitumumab With IFL|Panitumumab in combination with irinotecan, 5-fluorouracil and leucovorin (IFL chemotherapy regimen)
558767|NCT00111761|O1|Outcome|Panitumumab With FOLFIRI|Panitumumab in combination with irinotecan/5-FU/leucovorin chemotherapy (the FOLFIRI regimen)
558768|NCT00111761|E2|Reported Event|Panitumumab Plus FOLFIRI|
558769|NCT00111761|E1|Reported Event|Panitumumab Plus IFL|
558770|NCT00111657|B1|Baseline|Single Arm - Pegloticase|
558771|NCT00111657|P1|Participant Flow|Single Arm - Pegloticase|
558772|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
558773|NCT00111657|O1|Outcome|Single Arm - Pegloticase|
558774|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
558775|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
558776|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
558777|NCT00111657|O1|Outcome|Pegloticase|"All study participants received intravenous pegloticase at dose of 8 mg, administered every 21 days for a maximum of 5 doses.~There was no control group for this open label study.~Pegloticase: 8 mg of Pegloticase administered IV every 3 weeks; total number of infusions is 5"
558778|NCT00111657|O1|Outcome|Single Arm|
558779|NCT00111657|E1|Reported Event|Single Arm - Pegloticase|
558780|NCT00111007|B3|Baseline|Total|Total of all reporting groups
558781|NCT00111007|B2|Baseline|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558782|NCT00111007|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558783|NCT00111007|P2|Participant Flow|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558784|NCT00111007|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558785|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558786|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558787|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558788|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558789|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
559059|NCT00110357|O1|Outcome|CNS Primary Tumor|
559060|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559061|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
558790|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558791|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558792|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558793|NCT00111007|O2|Outcome|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558794|NCT00111007|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558795|NCT00111007|E2|Reported Event|Carboplatin/Paclitaxel (C/P)|Placebo, 2 tablets bid on Study Days 2-19 + Paclitaxel (225 mg/m^2 iv) and Carboplatin (AUC 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558796|NCT00111007|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib, 400 mg orally, 2 tablets (200 mg each) bid (bis in die [twice daily]) on Study Days 2 to 19 + Paclitaxel (225 mg/m^2 iv [Intravenous]) and Carboplatin (AUC [area under the curve] 6 iv) on Study Day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558797|NCT00110994|B3|Baseline|Total|Total of all reporting groups
558798|NCT00110994|B2|Baseline|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558799|NCT00110994|B1|Baseline|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558800|NCT00110994|P2|Participant Flow|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558801|NCT00110994|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558802|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558803|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558804|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
559062|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559063|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
559154|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
558805|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558806|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558807|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558808|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558809|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558810|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558811|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558812|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558813|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558814|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558815|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558816|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558817|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558818|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558819|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
559064|NCT00110357|O2|Outcome|Group A: 150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
559065|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
558820|NCT00110994|O2|Outcome|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558821|NCT00110994|O1|Outcome|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558822|NCT00110994|E2|Reported Event|Placebo + Dacarbazine|Placebo, 2 tablets orally twice daily on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558823|NCT00110994|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006) + Dacarbazine|Sorafenib, 2 tablets (200 mg each) orally twice daily (bid) on study days 1-21 + Dacarbazine, 1000 mg/m^2 intravenous on study day 1 (21 days per cycle) for double-blind (DB) treatment. Subjects who discontinued DB treatment with complete response (CR), partial response (PR) or stable disease (SD) entered active follow up period. Subjects who discontinued DB treatment with disease progression (DP) entered long term follow up period.
558824|NCT00110890|B3|Baseline|Total|Total of all reporting groups
558825|NCT00110890|B2|Baseline|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558826|NCT00110890|B1|Baseline|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558827|NCT00110890|P2|Participant Flow|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558828|NCT00110890|P1|Participant Flow|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558829|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558830|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558831|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558832|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558833|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558834|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558835|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558836|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558837|NCT00110890|O2|Outcome|Standard of Care|Subjects randomised to the standard care arm are to receive appropriate therapy in accordance with the investigator’s practice in an attempt to achieve the Kidney Disease Outcomes Quality Initiative (K/DOQI) parathyroid hormone (PTH), serum calcium, phosphorus, and Ca x P treatment targets.
558838|NCT00110890|O1|Outcome|Cinacalcet|Treatment with cinacalcet will be initiated at a dose of 30 mg/day. Possible daily doses of cinacalcet are 30, 60, 90, 120, and 180 mg. Dose escalation of cinacalcet may occur based on intact parathyroid hormone (iPTH) values.
558839|NCT00110890|E2|Reported Event|Cinacalcet|
558840|NCT00110890|E1|Reported Event|Standard Care|
558841|NCT00110812|B4|Baseline|Total|Total of all reporting groups
558842|NCT00110812|B3|Baseline|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558843|NCT00110812|B2|Baseline|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558844|NCT00110812|B1|Baseline|No IL-2|Participants will receive no aldesleukin or HAART
558845|NCT00110812|P3|Participant Flow|IL-2 With Pericycle HAART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle). Patients did not receive aldesleukin during the extension phase.
558846|NCT00110812|P2|Participant Flow|IL-2 Without ART|During the main study, participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level. Patients did not receive aldesleukin during the extension phase.
558847|NCT00110812|P1|Participant Flow|No IL-2|Participants will receive no aldesleukin or HAART during the main study or extension
558848|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
558849|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
558850|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
558851|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
558852|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
558853|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
558854|NCT00110812|O2|Outcome|Control|Consenting patients who were in the control group during the main phase of the trial.
558855|NCT00110812|O1|Outcome|IL-2|Consenting patients who were assigned IL-2 during the main phase of the study, including patients who took IL-2 alone as well as patients who took IL-2 with ART.
558856|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558857|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558858|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558859|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558860|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558861|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558862|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558863|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558864|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558865|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558866|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558867|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558868|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558869|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558870|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558871|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558872|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558873|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558874|NCT00110812|O1|Outcome|IL-2 With Pericycle HAART|
558875|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558876|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558877|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558878|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558879|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558880|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558881|NCT00110812|O2|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558882|NCT00110812|O1|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558883|NCT00110812|O3|Outcome|IL-2 With Pericycle HAART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level; in addition, this group will also take HAART for 3 days prior to the start of each aldesleukin cycle, throughout the 5-day aldesleukin cycle, and for 2 days after the end of each aldesleukin cycle (for a maximum of 10 days with each aldesleukin cycle).
558884|NCT00110812|O2|Outcome|IL-2 Without ART|Participants will receive aldesleukin under the skin twice daily for 5 consecutive days every 8 weeks for 3 cycles, then as needed to maintain CD4 counts at or above a goal level.
558885|NCT00110812|O1|Outcome|No IL-2|Participants will receive no aldesleukin or HAART
558886|NCT00110812|E3|Reported Event|No IL-2|
558887|NCT00110812|E2|Reported Event|IL-2 Without ART|
558888|NCT00110812|E1|Reported Event|IL-2 With Pericylce HAART|
558889|NCT00110617|B3|Baseline|Total|Total of all reporting groups
558890|NCT00110617|B2|Baseline|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
558891|NCT00110617|B1|Baseline|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558892|NCT00110617|P2|Participant Flow|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
558893|NCT00110617|P1|Participant Flow|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558894|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558895|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
558896|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558897|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
558898|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558899|NCT00110617|O2|Outcome|Deferoxamine (DFO) Then ICL670|Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg for 24 weeks then crossed over to receive Deferasirox (ICL670) orally 20 mg/kg for a total of 104 weeks on therapy.
558900|NCT00110617|O1|Outcome|Deferasirox (ICL670)|Deferasirox (ICL670) 20 mg/kg orally once daily for 104 weeks.
558901|NCT00110617|E4|Reported Event|Period 2 Deferoxamine (DFO) Then ICL670|Period 2 (After 24 weeks) DFO group cross over to Deferasirox (ICL670) orally 20 mg/kg completing 52 weeks on therapy and then entering an extension period.
558902|NCT00110617|E3|Reported Event|Period 2 Deferasirox (ICL670)|Period 2 (after 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
558903|NCT00110617|E2|Reported Event|Period 1 Deferoxamine (DFO)|Period 1 (first 24 weeks) Deferoxamine (DFO) subcutaneously for a weekly dose of 175 mg/kg.
558904|NCT00110617|E1|Reported Event|Period 1 Deferasirox (ICL670)|Period 1 (first 24 weeks) Deferasirox (ICL670) 20 mg/kg orally once daily.
558905|NCT00110513|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
558906|NCT00110513|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
559066|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559067|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
558907|NCT00110513|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level >80% and <120% of normal.
558908|NCT00110513|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Up to 24 hours prior to the scheduled elective surgical procedure, caesarean section, or delivery induction, each patient received an initial intravenous loading dose of recombinant human antithrombin (rhAT)followed by a continuous intravenous infusion dose of recombinant human antithrombin (rhAT) to maintain an antithrombin (AT) activity level of >80% and <120% of normal.
558909|NCT00110461|B4|Baseline|Total|Total of all reporting groups
558910|NCT00110461|B3|Baseline|Placebo|Participants were given a single pill administered once daily.
558911|NCT00110461|B2|Baseline|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558912|NCT00110461|B1|Baseline|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558913|NCT00110461|P3|Participant Flow|Placebo|Participants were given a single pill administered once daily.
558914|NCT00110461|P2|Participant Flow|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558915|NCT00110461|P1|Participant Flow|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558916|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558917|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558918|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558919|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558920|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558921|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558922|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558923|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558924|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558925|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558926|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558927|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558928|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558929|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558930|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558931|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
559068|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
558932|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558933|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558934|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558935|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558936|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558937|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558938|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558939|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558940|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558941|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558942|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558943|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558944|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558945|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558946|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558947|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558948|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558949|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558950|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558951|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558952|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558953|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558954|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558955|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
559069|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
559070|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
559071|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
558956|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558957|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558958|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558959|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558960|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558961|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558962|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558963|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558964|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558965|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558966|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558967|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558968|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558969|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558970|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558971|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558972|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558973|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558974|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558975|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558976|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558977|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558978|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558979|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
559072|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559073|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559074|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
558980|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558981|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558982|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558983|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558984|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558985|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558986|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558987|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558988|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558989|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558990|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558991|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558992|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558993|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558994|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558995|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558996|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
558997|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
558998|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
558999|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
559000|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
559001|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
559002|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
559003|NCT00110461|O3|Outcome|Placebo|Participants were given a single pill administered once daily.
559075|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
559076|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
559077|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
559004|NCT00110461|O2|Outcome|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
559005|NCT00110461|O1|Outcome|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
559006|NCT00110461|E3|Reported Event|Placebo|Participants were given a single pill administered once daily.
559007|NCT00110461|E2|Reported Event|Aripiprazole 30 mg/Day|Dose was titrated to a target dose of 30 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, 25 mg/day on Day 11, and 30 mg/day on Day 13. One dose reduction to 15 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 20 mg/day if needed.
559008|NCT00110461|E1|Reported Event|Aripiprazole 10 mg/Day|Dose was titrated to a target dose of 10 mg/day as follows: Starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5. One dose reduction to 5 mg/day was allowed in the extension phase. Following a dose reduction, the dose could be up titrated to 10 mg/day if needed.
559009|NCT00110396|B1|Baseline|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559010|NCT00110396|P1|Participant Flow|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559011|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559012|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559013|NCT00110396|O1|Outcome|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559014|NCT00110396|E1|Reported Event|Rebif New Formulation (RNF) Cohort|Interferon-beta-1a FBS-free/HSA-free Pre-filled syringes 44mcg/injected subcutaneous 3x per week
559015|NCT00110357|B3|Baseline|Total|Total of all reporting groups
559016|NCT00110357|B2|Baseline|13- to 18-years-old|
559017|NCT00110357|B1|Baseline|1- to 12-years-old|
559018|NCT00110357|P2|Participant Flow|13- to 18-years-old|
559019|NCT00110357|P1|Participant Flow|1- to 12-years-old|
559020|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559021|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559022|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559023|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559024|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559025|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
559026|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
559027|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559028|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559029|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559030|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559031|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559032|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
559033|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
559034|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559035|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559036|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559037|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559038|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559039|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
559040|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
559041|NCT00110357|O7|Outcome|Group B 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559042|NCT00110357|O6|Outcome|Group B 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559043|NCT00110357|O5|Outcome|Group B 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559044|NCT00110357|O4|Outcome|Group A 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559045|NCT00110357|O3|Outcome|Group A 150/20|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559046|NCT00110357|O2|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
559047|NCT00110357|O1|Outcome|Group A 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
559048|NCT00110357|O2|Outcome|Group B (Ages 13-18 Years)|
559049|NCT00110357|O1|Outcome|Group A (Ages 1-12 Years)|
559050|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559051|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559052|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559078|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559079|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559080|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559081|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
559082|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
559083|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
559084|NCT00110357|O6|Outcome|Group B: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559085|NCT00110357|O5|Outcome|Group B: 150|Cetuximab 150 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559086|NCT00110357|O4|Outcome|Group B: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 13-18 years of age
559087|NCT00110357|O3|Outcome|Group A: 250|Cetuximab 250 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years of age
559088|NCT00110357|O2|Outcome|Group A :150|Cetuximab 150 mg/m2 + 16-20 mg/m2 in participants 1-12 years of age
559089|NCT00110357|O1|Outcome|Group A: 75|Cetuximab 75 mg/m2 + Irinotecan 16-20 mg/m2 in participants 1-12 years
559090|NCT00110357|O7|Outcome|Group B: 250/20|Cetuximab 250 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559091|NCT00110357|O6|Outcome|Group B: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in subjects 13-18 years of age
559092|NCT00110357|O5|Outcome|Group B: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 13-18 years of age
559093|NCT00110357|O4|Outcome|Group A: 250/16|Cetuximab 250 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559094|NCT00110357|O3|Outcome|Group A 150/16|Cetuximab 150 mg/m2 + Irinotecan 16 mg/m2 in participants 1-12 years of age
559095|NCT00110357|O2|Outcome|Group A: 150/20|Cetuximab 150 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years of age
559096|NCT00110357|O1|Outcome|Group A: 75/20|Cetuximab 75 mg/m2 + Irinotecan 20 mg/m2 in participants 1-12 years
559097|NCT00110357|E5|Reported Event|05 250 mg/m2 CET + 20 mg/m2 IRI|
559098|NCT00110357|E4|Reported Event|04 250 mg/m2 CET + 16 mg/m2 IRI|
559099|NCT00110357|E3|Reported Event|03 150 mg/m2 CET + 16 mg/m2 IRI|
559100|NCT00110357|E2|Reported Event|02 150 mg/m2 CET + 20 mg/m2 IRI|
559101|NCT00110357|E1|Reported Event|01 75 mg/m2 CET + 20 mg/m2 IRI|
559102|NCT00110305|B5|Baseline|Total|Total of all reporting groups
559103|NCT00110305|B4|Baseline|Efavirenz|Efavirenz 600 mg once daily
559104|NCT00110305|B3|Baseline|TMC 150 mg|TMC278 150 mg once daily
559105|NCT00110305|B2|Baseline|TMC278 75 mg|TMC278 75 mg once daily
559106|NCT00110305|B1|Baseline|TMC278 25 mg|TMC278 25 mg once daily
559107|NCT00110305|P2|Participant Flow|Efavirenz|Efavirenz 600 mg once daily
559108|NCT00110305|P1|Participant Flow|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559109|NCT00110305|O4|Outcome|AUC24h Quartile 4|TMC278 25 mg, 75 mg, and 150 mg once daily
559110|NCT00110305|O3|Outcome|AUC24h Quartile 3|TMC278 25 mg, 75 mg, and 150 mg once daily
559111|NCT00110305|O2|Outcome|AUC24h Quartile 2|TMC278 25 mg, 75 mg, and 150 mg once daily
559112|NCT00110305|O1|Outcome|AUC24h Quartile 1|TMC278 25 mg, 75 mg, and 150 mg once daily
559113|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559114|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
559115|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
559116|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559117|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
559118|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
559119|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559120|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559121|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559122|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559123|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559124|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559125|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
559126|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559127|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559128|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
559129|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
559130|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
559131|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559132|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559133|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
559134|NCT00110305|O1|Outcome|TMC278 25mg|TMC278 25 mg once daily
559135|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559136|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559137|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559138|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559139|NCT00110305|O2|Outcome|Efavirenz|Efavirenz 600 mg once daily
559140|NCT00110305|O1|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559141|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
559142|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559143|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559144|NCT00110305|O2|Outcome|TMC278 75 mg|TMC278 75 mg once daily
559145|NCT00110305|O1|Outcome|TMC278 25 mg|TMC278 25 mg once daily
559146|NCT00110305|O5|Outcome|Efavirenz|Efavirenz 600 mg once daily
559147|NCT00110305|O4|Outcome|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559148|NCT00110305|O3|Outcome|TMC278 150 mg|TMC278 150 mg once daily
559157|NCT00110305|E1|Reported Event|All TMC278|TMC278 25 mg, 75 mg, and 150 mg once daily
559158|NCT00110214|B3|Baseline|Total|Total of all reporting groups
559159|NCT00110214|B2|Baseline|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559160|NCT00110214|B1|Baseline|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559161|NCT00110214|P2|Participant Flow|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559162|NCT00110214|P1|Participant Flow|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559163|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559164|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559165|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559166|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559167|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559168|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559169|NCT00110214|O2|Outcome|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559170|NCT00110214|O1|Outcome|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559171|NCT00110214|E2|Reported Event|Docetaxel + Bevacizumab|Std Tx + monoclonal antibody therapy Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Bevacizumab: 15 mg/kg IV every 3 weeks
559172|NCT00110214|E1|Reported Event|Docetaxel + Placebo|Standard treatment Docetaxel: 75 mg/m2 by IV over 1 hour for 21 days, Prednisone: 5mg orally twice per day Placebo
559173|NCT00110136|B1|Baseline|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559174|NCT00110136|P1|Participant Flow|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559175|NCT00110136|O1|Outcome|St. John's Wort|"Patients given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559176|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559177|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559178|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559179|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559180|NCT00110136|O1|Outcome|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559181|NCT00110136|E1|Reported Event|St. John's Wort|"Patient given one 300mg St. John's Wort tablet three times per day~St. John's Wort: St. John's Wort 300mg tablet three times per day"
559182|NCT00110084|B1|Baseline|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559183|NCT00110084|P1|Participant Flow|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559184|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559185|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559186|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559187|NCT00110084|O1|Outcome|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559188|NCT00110084|E1|Reported Event|Nab-paclitaxel/Gemcitabine|Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
559189|NCT00110019|B3|Baseline|Total|Total of all reporting groups
559190|NCT00110019|B2|Baseline|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
559191|NCT00110019|B1|Baseline|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559192|NCT00110019|P2|Participant Flow|Arm II (Carboplatin+Paclitaxel)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
560030|NCT00107042|O2|Outcome|Overweight and Obese (>=25.0)|Subjects whose BMIs were >= 25.0
559193|NCT00110019|P1|Participant Flow|Arm I (Carboplatin+Paclitaxel+Sorafenib)|Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559194|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
559195|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559196|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
559197|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559198|NCT00110019|O2|Outcome|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
559199|NCT00110019|O1|Outcome|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559200|NCT00110019|E2|Reported Event|Arm II (Carboplatin + Paclitaxel+Placebo)|Patients receive paclitaxel and carboplatin as in arm I. Patients also receive oral placebo twice daily on days 2-19.
559201|NCT00110019|E1|Reported Event|Arm I (Carboplatin + Paclitaxel + Sorafenib)|Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral sorafenib twice daily on days 2-19.
559202|NCT00109967|B3|Baseline|Total|Total of all reporting groups
559203|NCT00109967|B2|Baseline|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
559204|NCT00109967|B1|Baseline|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV temsirolimus: 25 mg given IV"
559205|NCT00109967|P2|Participant Flow|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559206|NCT00109967|P1|Participant Flow|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559207|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559208|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559222|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
560031|NCT00107042|O1|Outcome|Normal and Underweight (< 25.0)|Subjects whose BMIs were normal to < 25.0
559209|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559210|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559211|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559212|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559213|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559214|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559215|NCT00109967|O2|Outcome|Group II: Rituximab Refractory|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559216|NCT00109967|O1|Outcome|Group I: Rituximab Sensitive|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Patients also receive rituximab IV on days 1, 8, 15, and 22 of course 1 and on day 1 only of courses 3, 5, 7, 9, and 11. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. After completion of course 3, patients undergo reevaluation. Patients achieving a CR or an unconfirmed CR (CRu) receive 2 additional courses of treatment for a total of 5 courses. Patients achieving a PR or stable disease continue study treatment as outlined above for up to 12 courses. Patients achieving a PR or stable disease who subsequently achieve a CR or CRu between courses 3 and 10 receive 2 additional courses of treatment.~rituximab: 375 mg/m^2 Given IV~temsirolimus: 25 mg given IV"
559217|NCT00109967|E2|Reported Event|Group II: Rituximab Refractory|temsirolimus: 25 mg given IV
559218|NCT00109967|E1|Reported Event|Group I: Rituximab Sensitive|temsirolimus: 25 mg given IV
559219|NCT00109928|B1|Baseline|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
559220|NCT00109928|P1|Participant Flow|PEGS|Patients received IV cisplatin 25 mg/m2 days 1–4, etoposide 40 mg/m2 days 1–4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1–4 of a 21 day cycle for 6 cycles.
559221|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1 to 4, etoposide 40 mg/m2 days 1 to 4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1 to 4 of a 21 day cycle for 6 cycles.)
559223|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
559224|NCT00109928|O1|Outcome|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.
559225|NCT00109928|E1|Reported Event|PEGS|Patients received IV cisplatin 25 mg/m2 days 1-4, etoposide 40 mg/m2 days 1-4, gemcitabine 1000 mg/m2 day 1 and solumedrol 250 mg days 1-4 of a 21 day cycle for 6 cycles.)
559226|NCT00109876|B1|Baseline|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559227|NCT00109876|P1|Participant Flow|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559228|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559229|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559230|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559231|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559232|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559233|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559234|NCT00109876|O1|Outcome|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559235|NCT00109876|E1|Reported Event|RFA Therapy|Patients undergo radiofrequency ablation (RFA) directly to the tumor for up to 12 minutes to obtain an intratumoral temperature > 60° C. Patients may receive 3 RFA treatments (a total of 36 minutes) to obtain the target temperature.
559236|NCT00109850|B1|Baseline|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
559237|NCT00109850|P1|Participant Flow|Treatment|Cetuximab+Cisplatin+Irinotecan followed by radiation therapy (RT) in Cycle 3
559238|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
559239|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
559240|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
559241|NCT00109850|O1|Outcome|Cetuximab+Cisplatin+Irinotecan Followed by Radiation Therapy|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
559242|NCT00109850|E1|Reported Event|Cetuximab+Cisplatin+Irinotecan Followed by RT in Cycle 3|Patients received four 21-day cycles of cetuximab 400 mg/m^2 (day 1, cycle 1), cetuximab 250 mg/m^2 (day 8, 15, cycle 1, then days 1, 8 and 15 for subsequent cycles), cisplatin 30 mg/m^2 (days 1 and 8, all cycles), and irinotecan 65 mg/m^2 (days 1 and 8, all cycles). Thoracic Radiotherapy (TRT) was administered at 1.8 Gy in 28 daily fractions to a total dose of 50.4 Gy, beginning on day 1 of cycle 3.
559243|NCT00109837|B1|Baseline|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
559244|NCT00109837|P1|Participant Flow|Treatment|"Treatment included:~Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth"
559245|NCT00109837|O1|Outcome|Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
559246|NCT00109837|O1|Outcome|Treatment|Treatment included: Induc 1: Allo; Dauno; Vin; Pred; asparag; Bactrim Induc 2: Allo; AraC; Dex; GCSF; Mitx; Meth; leuc; Meth Consol: cyclo; AraC; 6-mercapto; Meth; GCSF Maint:Course 1: 6-mercapto; Meth 20 Course 2: Vincristine; Adriamycin; Dex Course 3: Cyclo; 6-thio; AraC Course 4: 6-mercapto; meth
571843|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
559247|NCT00109837|E4|Reported Event|Maintenance|Patient with a CR after consolidation could receive up to four courses of maintenance. Course 1 included 6-mercaptopurine and methotrexate. course 2 included vincristine, adriamycin, and dexamethasone. course 3 included cyclophosphamide, 6-thioguanine, and ara-C. course 4 included 6-mercaptopurine and methotrexate
559248|NCT00109837|E3|Reported Event|Consolidation|Patients who had a CR after induction could receive one course of consolidation therapy consisting of cyclophosphamide, ara-C, 6-mercaptopurine, G-CSF and methotrexate
559249|NCT00109837|E2|Reported Event|Second Induction|A second induction cycle with allopurinol , dexamergasone, G-CSF, high-dose ara-C and mitoxantrone
559250|NCT00109837|E1|Reported Event|First Induction|One induction cycle with allopurinol, daunorubicin, vincristine, prednisone, amd PEG- L-asparaginase.
559251|NCT00109772|B3|Baseline|Total|Total of all reporting groups
559252|NCT00109772|B2|Baseline|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559253|NCT00109772|B1|Baseline|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559254|NCT00109772|P2|Participant Flow|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559255|NCT00109772|P1|Participant Flow|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559256|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559257|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559258|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559259|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559260|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559261|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559262|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559263|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559264|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559265|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559266|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559267|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559268|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559269|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559270|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559271|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559272|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559273|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559274|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559275|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559276|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559277|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559278|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559279|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559280|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559281|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559282|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559283|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559284|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559285|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559286|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559287|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559288|NCT00109772|O2|Outcome|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559289|NCT00109772|O1|Outcome|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559290|NCT00109772|E2|Reported Event|Placebo to Lenalidomide|Placebo orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of crossing over to lenalidomide 10mg in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559291|NCT00109772|E1|Reported Event|Lenalidomide|10 mg/day lenalidomide orally for up to 12 weeks in the double-blind treatment period. Participants who completed double-blind treatment had the option of continuing on lenalidomide in the open-label extension period for as long as benefit was derived from the drug or until study closure.
559292|NCT00109733|B3|Baseline|Total|Total of all reporting groups
559293|NCT00109733|B2|Baseline|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559294|NCT00109733|B1|Baseline|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559295|NCT00109733|P2|Participant Flow|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559296|NCT00109733|P1|Participant Flow|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559297|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559298|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559299|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559300|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559301|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559302|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559303|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559304|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559305|NCT00109733|O2|Outcome|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559306|NCT00109733|O1|Outcome|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559307|NCT00109733|E2|Reported Event|High Dose Group|0.010 mg/kg/day recombinant human growth hormone for 14 days with the opportunity to dose escalate, with the Investigator's approval, on Day 15 to 0.02 mg/kg/day and Day 29 to 0.03 mg/kg/day.
559308|NCT00109733|E1|Reported Event|Standard Dose Group|0.005 mg/kg/day recombinant human growth hormone(r-hGH)for 30 days then increasing, with the Investigator's approval, to 0.010 mg/kg/day from Day 31 to Week 24.
559309|NCT00109590|B4|Baseline|Total|Total of all reporting groups
559310|NCT00109590|B3|Baseline|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559311|NCT00109590|B2|Baseline|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559312|NCT00109590|B1|Baseline|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559313|NCT00109590|P3|Participant Flow|Arm C: LPV/r x 30d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559314|NCT00109590|P2|Participant Flow|Arm B : no LPV/r|Neviarpine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally once daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559315|NCT00109590|P1|Participant Flow|Arm A : LPV/r x 7d|Nevirapine (NVP) 200 mg orally, single dose at onset of labor, Zidovudine (ZDV) 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, didanosine (ddI) 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, > Lopinavir/Ritonavir (LPV/r) 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559316|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
559317|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
559318|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
559319|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
559320|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
559321|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
559322|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559517|NCT00109005|B1|Baseline|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
559323|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559324|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally QD (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559325|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559326|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559327|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559328|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559329|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559330|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559331|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559332|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559333|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559334|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559335|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559336|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559337|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559338|NCT00109590|O2|Outcome|Arm B: no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559339|NCT00109590|O1|Outcome|Arm A: LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7days postpartum.
559340|NCT00109590|O2|Outcome|At Day 30 Ppm|ZDV, ddI, LPV/r x 30d
559341|NCT00109590|O1|Outcome|Within 72 Hrs Ppm|ZDV, ddI, LPV/r x 30d
559428|NCT00109343|E3|Reported Event|ProQuad™ (After Dose 2)|ProQuad™ (After Dose 2) includes Days 1 to 28 after the second dose of ProQuad™ (safety follow-up period 3 for Group 1, Group 2, and Group 3).
559342|NCT00109590|O3|Outcome|Arm C : LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559343|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559344|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559345|NCT00109590|O3|Outcome|Arm C: LPV/r x 30d|NVP 200 mg orally, single dose at onset of labor,ZDV 300 mg orally at onset of labor, evry 3 hours during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 30 days postpartum.
559346|NCT00109590|O2|Outcome|Arm B : no LPV/r|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, q3h during labor and twice daily for 30 days postpartum, ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 30 days postpartum.
559347|NCT00109590|O1|Outcome|Arm A : LPV/r x 7d|NVP 200 mg orally, single dose at onset of labor, ZDV 300 mg orally at onset of labor, every 3 hours during labor and twice daily for 7 days postpartum ddI 250 mg orally (if body weight <60 kg) or 400 mg orally daily (if body weight >= 60 kg) at the onset of labor, during labor, and for 7 days postpartum, LPV/r 400/100mg orally twice daily at the onset of labor, during labor and for 7 days postpartum.
559348|NCT00109590|E6|Reported Event|Infant: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
559349|NCT00109590|E5|Reported Event|Infant: no LPV/r|ZDV & ddI x 30d
559350|NCT00109590|E4|Reported Event|Infant: LPV/r x 7d|NVP 200 mg orally, single dose at onset
559351|NCT00109590|E3|Reported Event|Mother: LPV/r x 30d|ZDV, ddI, LPV/r x 30d
559352|NCT00109590|E2|Reported Event|Mother: no LPV/r|ZDV & ddI x 30d
559353|NCT00109590|E1|Reported Event|Mother: LPV/r x 7d|NVP 200 mg orally, single dose at onset
559354|NCT00109577|B3|Baseline|Total|Total of all reporting groups
559355|NCT00109577|B2|Baseline|Micronutrient Formula|nutritional supplement
559356|NCT00109577|B1|Baseline|Placebo Comparator|Placebo comparator
559357|NCT00109577|P2|Participant Flow|Micronutrient Formula|nutritional supplement capsules containing 36-ingredients primarily vitamins and minerals; the supplement is referred to as MCN36, because it contains 36 nutrients.
559358|NCT00109577|P1|Participant Flow|Placebo Comparator|Placebo comparator capsules
559359|NCT00109577|O2|Outcome|Micronutrient Formula|nutritional supplement capsules
559360|NCT00109577|O1|Outcome|Placebo Comparator|Placebo comparator capsules
559361|NCT00109577|E2|Reported Event|Micronutrient Formula|nutritional supplement
559362|NCT00109577|E1|Reported Event|Placebo Comparator|Placebo comparator
559363|NCT00109473|B3|Baseline|Total|Total of all reporting groups
559364|NCT00109473|B2|Baseline|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559365|NCT00109473|B1|Baseline|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559366|NCT00109473|P2|Participant Flow|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559367|NCT00109473|P1|Participant Flow|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559368|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559369|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559370|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559371|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559372|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559373|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559374|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559375|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559376|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559377|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559378|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559379|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559380|NCT00109473|O2|Outcome|Corticosteroid (CTX)|Subjects took corticosteroid as prescribed by their physician
559381|NCT00109473|O1|Outcome|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559382|NCT00109473|E3|Reported Event|Extension Phase|Eligible subjects from both group A and group B continued on growth hormone in a 52 week extension phase
559383|NCT00109473|E2|Reported Event|Corticosteroid (CTX)|Subjects took corticosteroid as recommended by their physician
559384|NCT00109473|E1|Reported Event|Growth Hormone Plus Corticosteroid (CTX)|Growth Hormone (nutropin AQ 0.075 mg/kg/day subcutaneously daily)
559385|NCT00109343|B4|Baseline|Total|Total of all reporting groups
559516|NCT00109005|B2|Baseline|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559386|NCT00109343|B3|Baseline|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559387|NCT00109343|B2|Baseline|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559388|NCT00109343|B1|Baseline|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559389|NCT00109343|P3|Participant Flow|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559390|NCT00109343|P2|Participant Flow|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559391|NCT00109343|P1|Participant Flow|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559392|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559393|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559394|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559395|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559396|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559397|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559398|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559399|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559400|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559401|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559402|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559403|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559404|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559405|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559406|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559407|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559408|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559409|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559410|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559411|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559412|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559413|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559414|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559415|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559416|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559417|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559418|NCT00109343|O2|Outcome|Group 2 - PREVNAR™ Followed by ProQuad™|Group 2 – Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 1. ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 133) after the first dose.
559419|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559420|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559421|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559422|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559423|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559424|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559425|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559426|NCT00109343|O2|Outcome|Group 3 - ProQuad™ Followed by PREVNAR™|Group 3 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) administered on Day 1. Fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered on Day 43. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559427|NCT00109343|O1|Outcome|Group 1 - ProQuad™ + PREVNAR™|Group 1 – ProQuad™ (measles, mumps, rubella, and varicella vaccine) + fourth dose of PREVNAR™ (pneumococcal 7-valent conjugate vaccine) administered concomitantly at separate injection sites on Day 1. Second dose of ProQuad™ administered at least 90 days (Day 91) after the first dose.
559429|NCT00109343|E2|Reported Event|ProQuad™ Alone (After Dose 1)|ProQuad™ Alone (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 3 and safety follow-up period 2 for Group 2).
559430|NCT00109343|E1|Reported Event|ProQuad™ + Prevnar™ (After Dose 1)|ProQuad™ + Prevnar™ (After Dose 1) includes Days 1 to 28 after the first dose of ProQuad™ (safety follow-up period 1 for Group 1)
559431|NCT00107900|B7|Baseline|Total|Total of all reporting groups
559432|NCT00107900|B6|Baseline|120mg QD|120mg edoxaban administered once daily (QD)
559433|NCT00107900|B5|Baseline|60mg BID|60mg edoxaban administered twice daily (BID)
559434|NCT00107900|B4|Baseline|60mg QD|60mg edoxaban administered once daily (QD)
559435|NCT00107900|B3|Baseline|30mg BID|30mg edoxaban administered twice daily (BID)
559436|NCT00107900|B2|Baseline|30mg QD|30mg edoxaban administered once daily (QD)
559437|NCT00107900|B1|Baseline|15mg BID|15mg edoxaban administered twice daily (BID)
559438|NCT00107900|P6|Participant Flow|120mg QD|120mg edoxaban administered once daily (QD)
559439|NCT00107900|P5|Participant Flow|60mg BID|60mg edoxaban administered twice daily (BID)
559440|NCT00107900|P4|Participant Flow|60mg QD|60mg edoxaban administered once daily (QD)
559441|NCT00107900|P3|Participant Flow|30mg BID|30mg edoxaban administered twice daily (BID)
559442|NCT00107900|P2|Participant Flow|30mg QD|30mg edoxaban administered once daily (QD)
559443|NCT00107900|P1|Participant Flow|15mg BID|15mg edoxaban administered twice daily (BID)
559444|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
559445|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
559446|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
559447|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
559448|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
559449|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
559450|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
559451|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
559452|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
559453|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
559454|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
559455|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
559456|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
559457|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
559458|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
559459|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
559460|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
559461|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
559462|NCT00107900|O6|Outcome|120mg QD|120mg edoxaban administered once daily (QD)
559463|NCT00107900|O5|Outcome|60mg BID|60mg edoxaban administered twice daily (BID)
559464|NCT00107900|O4|Outcome|60mg QD|60mg edoxaban administered once daily (QD)
559465|NCT00107900|O3|Outcome|30mg BID|30mg edoxaban administered twice daily (BID)
559466|NCT00107900|O2|Outcome|30mg QD|30mg edoxaban administered once daily (QD)
559467|NCT00107900|O1|Outcome|15mg BID|15mg edoxaban administered twice daily (BID)
559468|NCT00107900|E6|Reported Event|120mg QD|120mg edoxaban administered once daily (QD)
559469|NCT00107900|E5|Reported Event|60mg BID|60mg edoxaban administered twice daily (BID)
559470|NCT00107900|E4|Reported Event|60mg QD|60mg edoxaban administered once daily (QD)
559471|NCT00107900|E3|Reported Event|30mg BID|30mg edoxaban administered twice daily (BID)
559472|NCT00107900|E2|Reported Event|30mg QD|30mg edoxaban administered once daily (QD)
559473|NCT00107900|E1|Reported Event|15mg BID|15mg edoxaban administered twice daily (BID)
559474|NCT00109031|B5|Baseline|Total|Total of all reporting groups
559475|NCT00109031|B4|Baseline|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559476|NCT00109031|B3|Baseline|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559477|NCT00109031|B2|Baseline|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559478|NCT00109031|B1|Baseline|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559479|NCT00109031|P4|Participant Flow|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
559480|NCT00109031|P3|Participant Flow|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
559481|NCT00109031|P2|Participant Flow|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and matched placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC. Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
559482|NCT00109031|P1|Participant Flow|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg plus placebo to match the total volume equivalent to a 180 µg/kg dose on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC). Participants also received conditioning therapy with fTBI and cyclophosphamide/etoposide prior to PBPC transplantation on Day 0.
559483|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559484|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559485|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559486|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559487|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559488|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559489|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559490|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559491|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559492|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559493|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559494|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559495|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559496|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559497|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559498|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559499|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559500|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559501|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559502|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559503|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559504|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559505|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559506|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559507|NCT00109031|O4|Outcome|Palifermin 180 μg/kg on Day −3|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559508|NCT00109031|O3|Outcome|Palifermin 180 μg/kg on Day −2|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559509|NCT00109031|O2|Outcome|Palifermin 180 μg/kg on Day −1|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559510|NCT00109031|O1|Outcome|Palifermin 60 µg/kg for 3 Days|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559511|NCT00109031|E4|Reported Event|Palifermin 180 μg/kg on Day −3 (D)|Palifermin 180 μg/kg on Day −3 and placebo on Days −1 and −2 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559512|NCT00109031|E3|Reported Event|Palifermin 180 μg/kg on Day −2 (C)|Palifermin 180 μg/kg on Day −2 and placebo on Days −1 and -3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559513|NCT00109031|E2|Reported Event|Palifermin 180 μg/kg on Day −1 (B)|Palifermin 180 μg/kg on Day −1 and placebo on Days −2 and −3 prior to fTBI, and palifermin 60 μg/kg on Days 0, 1, and 2 after PBPC.
559514|NCT00109031|E1|Reported Event|Palifermin 60 µg/kg for 3 Days (A)|Palifermin 60 µg/kg on the 3 days prior to fractionated total body irradiation (fTBI) and palifermin 60 µg/kg on Days 0, 1 and 2 after peripheral blood progenitor cell transplantation (PBPC).
559515|NCT00109005|B3|Baseline|Total|Total of all reporting groups
559518|NCT00109005|P2|Participant Flow|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559519|NCT00109005|P1|Participant Flow|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
559520|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559521|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559522|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559523|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559524|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559525|NCT00109005|O2|Outcome|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559526|NCT00109005|O1|Outcome|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
559527|NCT00109005|O1|Outcome|Cohort 1 & 2 -25 mg & 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559528|NCT00109005|E2|Reported Event|Cohort 2 - 5 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 5 mg per day 7 days a week for 3 weeks
559529|NCT00109005|E1|Reported Event|Cohort 1 - 25 mg Lenalidomide (Revlimid)|oral dose (1 capsule) lenalidomide 25 mg per day 7 days a week for 3 weeks
559530|NCT00108953|B3|Baseline|Total|Total of all reporting groups
559531|NCT00108953|B2|Baseline|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559532|NCT00108953|B1|Baseline|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559533|NCT00108953|P2|Participant Flow|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559534|NCT00108953|P1|Participant Flow|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559535|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559536|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559537|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559538|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559539|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559540|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559541|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559542|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559543|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559544|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559545|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY 43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559546|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY 43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559547|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559548|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
560040|NCT00107042|O1|Outcome|Not Hispanic|Subjects who reported they were not of Hispanic ethnicity.
559549|NCT00108953|O2|Outcome|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559550|NCT00108953|O1|Outcome|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559551|NCT00108953|E2|Reported Event|Placebo + Doxorubicin|"Placebo + Doxorubicin -- monotherapy: Sorafenib (Nexavar, BAY43-9006) matching placebo tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559552|NCT00108953|E1|Reported Event|Sorafenib + Doxorubicin|"Sorafenib + Doxorubicin -- combination therapy: Sorafenib (Nexavar, BAY43-9006) 200 mg tablets by mouth (orally) twice daily + doxorubicin 60 mg/m2 intravenous infusion every 21 days for 6 cycles (18 weeks)"
559553|NCT00108862|B3|Baseline|Total|Total of all reporting groups
559554|NCT00108862|B2|Baseline|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559555|NCT00108862|B1|Baseline|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559556|NCT00108862|P2|Participant Flow|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559557|NCT00108862|P1|Participant Flow|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559558|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559559|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559560|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
560032|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Males)|Males who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
559561|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559562|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559563|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559564|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559565|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559566|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559567|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559568|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559609|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559569|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559570|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559571|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559572|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559573|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559574|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559575|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559576|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559676|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
560041|NCT00107042|O2|Outcome|Male|Male Subjects
559577|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559578|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559579|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559580|NCT00108862|O2|Outcome|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559581|NCT00108862|O1|Outcome|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559582|NCT00108862|E2|Reported Event|Deferred ART|These participants deferred ART until 8 to 12 weeks after initiation of their RIF- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were EFV 600 mg (provided to non-U.S. sites only; 1 tablet orally) and FTC 200 mg/TDF 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered NVP 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. FDA-approved or tentatively approved ARVs that were compatible with TB therapy could be used at the discretion of the site investigator.
559583|NCT00108862|E1|Reported Event|Immediate ART|These participants initiated HIV antiretroviral therapy (ART) within 72 hours of randomization, which took place at most 2 weeks after initiating rifampin (RIF)- or other rifamycin-based TB treatment according to in-country national TB treatment guidelines. The study-provided drugs were efavirenz (EFV) 600 mg (provided to non-U.S. sites only; 1 tablet orally) and emtricitabine (FTC) 200 mg/tenofovir disoproxil fumarate (TDF) 300 mg (1 fixed-dose combination tablet orally) once daily. FTC 200 mg (1 capsule) and TDF 300 mg (1 tablet) could be substituted for the fixed-dose combination tablet and was provided by the study. Participants who could not tolerate EFV could be offered nevirapine (NVP) 200 mg daily for 14 days, then 200 mg twice daily. Substitutions with other locally-available U.S. Food and Drug Administration (FDA)-approved or tentatively approved antiretrovirals (ARVs) that were compatible with TB therapy could be used at the discretion of the site investigator.
559584|NCT00108732|B1|Baseline|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559677|NCT00108355|E2|Reported Event|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
560033|NCT00107042|O1|Outcome|Tanner Stage 5 (Males)|Males who were self-assessed and categorized to Tanner Stage 5.
559585|NCT00108732|P1|Participant Flow|Vaccinia/Fowlpox/GM-CSF|"There are two steps in this study. Patients receive vaccine treatment in Step 1. Patients with biochemical or clinical progression during Step 1 were eligible to continue on to androgen blockade in Step 2. This report includes information collected in Step 1 only.~Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start Step II androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559586|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559587|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559588|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559589|NCT00108732|O1|Outcome|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559590|NCT00108732|E1|Reported Event|Vaccinia/Fowlpox/GM-CSF|"Patients receive vaccinia subcutaneously (SC) on day 1 and GM-CSF SC on days 1-4 during cycle 1. Beginning with cycle 2, patients receive fowlpox SC on day 1 and GM-CSF SC on days 1-4. Treatment with fowlpox and GM-CSF repeats every 4 weeks for 2 courses. Beginning in week 13, patients receive fowlpox and GM-CSF as above every 12 weeks in the absence of clinical or biochemical disease progression or unacceptable toxicity.~Patients with biochemical or clinical disease progression may start androgen ablation therapy comprising oral bicalutamide once daily for 1 month and goserelin SC once every 4 weeks in addition to fowlpox vaccine and GM-CSF until further progression or a max of 12 months."
559591|NCT00108628|B3|Baseline|Total|Total of all reporting groups
559592|NCT00108628|B2|Baseline|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559593|NCT00108628|B1|Baseline|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559594|NCT00108628|P2|Participant Flow|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559595|NCT00108628|P1|Participant Flow|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559657|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
560042|NCT00107042|O1|Outcome|Female|Female Subjects
559596|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559597|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559598|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559599|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559600|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559601|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559602|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559603|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559604|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559605|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559606|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559607|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559608|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
560034|NCT00107042|O2|Outcome|Tanner Stages 1-4 (Females)|Females who were self-assessed and categorized to Tanner Stages 1, 2, 3, or 4.
559610|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559611|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559612|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559613|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559614|NCT00108628|O2|Outcome|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559615|NCT00108628|O1|Outcome|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559616|NCT00108628|E2|Reported Event|Sleep and Nightmare Management|"Sleep and Nightmare Management~Sleep and Nightmare Management: This comparison condition involved psychoeducation about PTSD, sleep and nightmares, progressive muscle relaxation and standard CBT for insomnia. This latter part included education about sleep hygiene (e.g., avoidance of caffeine and alcohol close to bedtime, benefit of regular bed time routines), stimulus control and sleep restriction (i.e., reestablishing a conditioned association between the bed/bedroom and sleep by reducing time spent tossing and turning in bed). Therapists worked with patients to identify problem areas in their sleep habits and to problem-solve about possible treatment targets"
559617|NCT00108628|E1|Reported Event|Imagery Rehearsal Therapy|"Imagery Rehearsal Therapy~Imagery Rehearsal: IR is a manual-based CBT predicated on the idea that waking mental activity influences nighttime dreams. Veterans examine the content of a recurrent nightmare, use imagery to alter disturbing aspects of the nightmare to promote mastery and control, and rehearse the new dream nightly, before bedtime."
559618|NCT00108550|B3|Baseline|Total|Total of all reporting groups
559619|NCT00108550|B2|Baseline|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
559620|NCT00108550|B1|Baseline|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
559621|NCT00108550|P2|Participant Flow|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
559622|NCT00108550|P1|Participant Flow|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
559623|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
559624|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
559625|NCT00108550|O2|Outcome|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
559626|NCT00108550|O1|Outcome|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
559627|NCT00108550|E2|Reported Event|Gabapentin|gabapentin capsule 1200mg three times a day for 12 weeks
559628|NCT00108550|E1|Reported Event|Placebo|Inert placebo capsules, 3 capsules three times a day for 12 weeks
559629|NCT00108524|B3|Baseline|Total|Total of all reporting groups
559630|NCT00108524|B2|Baseline|Arm 2|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
559631|NCT00108524|B1|Baseline|Arm 1|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
559675|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
559632|NCT00108524|P2|Participant Flow|Low-Fat Diet Plus Orlistat|"Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.~Orlistat plus a low-fat diet: Participants were instructed to restrict intake of total fat (<30% of daily energy), saturated fat (<10% of daily energy), cholesterol (<300 mg daily), and calories using pocket guides, handouts, and individualized goals. Recommended calorie intake was 500 to 1000 kcal below a participant's calculated weight maintenance intake. In addition, a 30-day supply of orlistat (120 mg before meals 3 times a day) was provided monthly."
559633|NCT00108524|P1|Participant Flow|Low Carbohydrate Ketogenic Diet|"Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.~Low carbohydrate ketogenic diet: Participants were instructed to restrict carbohydrate intake initially to less than 20 g/d using pocket guides and handouts. Participants could eat unlimited meat and eggs, 112 g of hard cheese, 0.48 L of low-carbohydrate vegetables (eg, leafy greens), and 0.24 L of moderate-carbohydrate vegetables (eg, broccoli, asparagus) daily; calorie intake was not restricted. As participants approached their goal weight or if cravings threatened their adherence to the diet, they were advised to add approximately 5 g of carbohydrates to their daily intake each week until weight was maintained or cravings diminished."
559634|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
559635|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
559636|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
559637|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
559638|NCT00108524|O2|Outcome|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
559639|NCT00108524|O1|Outcome|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
559640|NCT00108524|E2|Reported Event|Arm 2|Orlistat plus a low-fat diet: Participants receive dietary counseling over 48 weeks aimed at reducing fat and calorie intake and additionally receive Orlistat taken 3 times daily.
559641|NCT00108524|E1|Reported Event|Arm 1|Low carbohydrate ketogenic diet: Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
559642|NCT00108485|B3|Baseline|Total|Total of all reporting groups
559643|NCT00108485|B2|Baseline|Placebo|Placebo tablets
559644|NCT00108485|B1|Baseline|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
559645|NCT00108485|P2|Participant Flow|Placebo|Placebo tablets
559646|NCT00108485|P1|Participant Flow|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
559647|NCT00108485|O2|Outcome|Placebo|Placebo tablets
559648|NCT00108485|O1|Outcome|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
559649|NCT00108485|E2|Reported Event|Placebo|Placebo tablets
559650|NCT00108485|E1|Reported Event|Extended Release Niacin|"Extended release niacin 1500-2000 mg daily versus placebo comparator~Extended release niacin: Extended release niacin 1500-2000mg once daily"
559651|NCT00108433|B3|Baseline|Total|Total of all reporting groups
559652|NCT00108433|B2|Baseline|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559653|NCT00108433|B1|Baseline|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559654|NCT00108433|P2|Participant Flow|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559655|NCT00108433|P1|Participant Flow|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559656|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
560035|NCT00107042|O1|Outcome|Tanner Stage 5 (Females)|Females who were self-assessed and categorized to Tanner Stage 5.
559658|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559659|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559660|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559661|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559662|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559663|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559664|NCT00108433|O2|Outcome|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559665|NCT00108433|O1|Outcome|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559666|NCT00108433|E2|Reported Event|Vancomycin/Cefazolin|Participants with catheter-related Gram-positive bloodstream infections received vancomycin intravenously at a loading dose of 15 mg/kg body weight and subsequent doses targeted to keep serum trough levels between 10 to15 mcg/mL along with intravenous gentamicin at a loading dose of 2 mg/kg body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 mcg/mL and trough levels less than 1 mcg/mL. Participants with a methicillin susceptible Gram-positive pathogen and not allergic to penicillin received cefazolin 1 gram (g) intravenously every 24 hours.
559667|NCT00108433|E1|Reported Event|Linezolid|Participants with catheter-related Gram-positive bloodstream infections received linezolid 600 milligram (mg) either intravenous injection or per oral tablet every 12 hours (hrs) along with intravenous gentamicin at a loading dose of 2 milligram/kilogram (mg/kg) body weight and subsequent doses targeted to keep serum peak levels between 6 to 8 microgram per milliliter (mcg/mL) and trough levels less than 1 mcg/mL, up to a maximum of 28 days.
559668|NCT00108355|B3|Baseline|Total|Total of all reporting groups
559669|NCT00108355|B2|Baseline|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
559670|NCT00108355|B1|Baseline|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
559671|NCT00108355|P2|Participant Flow|Vasoconstrictors (Study Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
559672|NCT00108355|P1|Participant Flow|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
559673|NCT00108355|O2|Outcome|Vasoconstrictor (Treatment Group)|"After LVP, patients in this group received:~Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose"
559674|NCT00108355|O1|Outcome|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
560036|NCT00107042|O3|Outcome|Black/African American|Subjects who reported their race to be black or African American
559678|NCT00108355|E1|Reported Event|Albumin (Control Group)|"After LVP, patients in this group received:~Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo)"
559679|NCT00108342|B3|Baseline|Total|Total of all reporting groups
559680|NCT00108342|B2|Baseline|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
559681|NCT00108342|B1|Baseline|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
559682|NCT00108342|P2|Participant Flow|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
559683|NCT00108342|P1|Participant Flow|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
559684|NCT00108342|O2|Outcome|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
559685|NCT00108342|O1|Outcome|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
559686|NCT00108342|E2|Reported Event|NRT Computer Learning|Computer learning: learning about 6 NRTs (3 forms x 2 dosages) by computer only
559687|NCT00108342|E1|Reported Event|NRT Sampling|"Sampling = actual 3 minute testing of each of 6 NRTs (3 forms x 2 dosages)~Nicotine gum - 2 mg and 4 mg~Nicotine lozenges - 2 mg and 4 mg~Nicotine inhaler - infrequent and frequent puffing for dosage (can yield 4 mg from 10 mg device)"
559688|NCT00107783|B3|Baseline|Total|Total of all reporting groups
559689|NCT00107783|B2|Baseline|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559690|NCT00107783|B1|Baseline|Control|No treatment
559691|NCT00107783|P2|Participant Flow|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559692|NCT00107783|P1|Participant Flow|Control|No treatment
559693|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559694|NCT00107783|O1|Outcome|Control|No treatment
559695|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559696|NCT00107783|O1|Outcome|Control|No treatment
559697|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559698|NCT00107783|O1|Outcome|Control|No treatment
559699|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559700|NCT00107783|O1|Outcome|Control|No treatment
559701|NCT00107783|O2|Outcome|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559702|NCT00107783|O1|Outcome|Control|No treatment
559703|NCT00107783|E2|Reported Event|Nitisinone-treated|Subjects received nitisinone 2 mg orally, once daily.
559704|NCT00107783|E1|Reported Event|Control|No treatment
559705|NCT00107653|B3|Baseline|Total|Total of all reporting groups
559706|NCT00107653|B2|Baseline|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559707|NCT00107653|B1|Baseline|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559708|NCT00107653|P2|Participant Flow|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559709|NCT00107653|P1|Participant Flow|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559710|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559711|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559712|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559769|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559770|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559713|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559714|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559715|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559716|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559717|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559718|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559719|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559720|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559721|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559722|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559723|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559724|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559725|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559726|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559727|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559728|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559771|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559729|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559730|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559731|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559732|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559733|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559734|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559735|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559736|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559737|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559738|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559739|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559740|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559741|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559742|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559743|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559744|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559772|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
560037|NCT00107042|O2|Outcome|Other/Mixed Race|Subjects who reported their race to be other than white, black, or of mixed race.
559745|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559746|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559747|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559748|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559749|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559750|NCT00107653|O2|Outcome|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559751|NCT00107653|O1|Outcome|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559752|NCT00107653|E2|Reported Event|Non-Latino White|Eligible participants received peginterferon alfa-2a 180 mcg/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day which was taken orally in split doses. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day. Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day for 48 weeks.
559753|NCT00107653|E1|Reported Event|Latino|Eligible participants received peginterferon alfa-2a 180 microgram (mcg)/0.5 mL by subcutaneous injection once a week in combination with ribavirin 1000 or 1200 mg per day, which was taken orally in split doses for 48 weeks. Participants with <75 kg (165 lbs) of body weight received 1000 mg/day (400 mg in the morning and 600 mg in the evening). Participants with >=75 kg (165 lbs) of body weight received 1200 mg/day (600 mg in the morning and 600 mg in the evening).
559754|NCT00107614|B1|Baseline|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
559755|NCT00107614|P1|Participant Flow|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
559756|NCT00107614|O1|Outcome|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
559757|NCT00107614|E1|Reported Event|Waldenstrom's Macroglobulinemia Patients|Participants must have a pathological diagnosis of Waldenstrom’s Macroglobulinemia, with advanced and/or symptomatic disease requiring therapy. At least one of the inclusion criteria:
559758|NCT00107575|B3|Baseline|Total|Total of all reporting groups
559759|NCT00107575|B2|Baseline|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559760|NCT00107575|B1|Baseline|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559761|NCT00107575|P2|Participant Flow|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559762|NCT00107575|P1|Participant Flow|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559763|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559764|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559765|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559766|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559767|NCT00107575|O2|Outcome|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559768|NCT00107575|O1|Outcome|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
560038|NCT00107042|O1|Outcome|White|Subjects who reported their race to be white.
559773|NCT00107575|E2|Reported Event|Standard Treatment Plus a Brief Alcohol Intervention (ST-BI)|Standard treatment of 4 individual behavior counseling sessions and nicotine patch, with treatment also incorporating brief alcohol intervention
559774|NCT00107575|E1|Reported Event|Standard Treatment|Standard smoking cessation treatment (ST) including 4 sessions of behavioral counseling and nicotine patch
559775|NCT00108303|B4|Baseline|Total|Total of all reporting groups
559776|NCT00108303|B3|Baseline|Controls|Persons who are not related to persons in Arm 2 and do not have schizophrenia themselves.
559777|NCT00108303|B2|Baseline|Schizophrenia Relatives|Persons who are first degree relatives of persons in Arm 1
559778|NCT00108303|B1|Baseline|Schizophrenia Probands|Persons who meet DSM-IV criteria for schizophrenia or schizoaffective disorder
559779|NCT00108303|P3|Participant Flow|Controls|Subjects who are unrelated to persons with schizophrenia and do not fulfill criteria for schizophrenia themselves.
559780|NCT00108303|P2|Participant Flow|Schizophrenia Relatives|Subjects who are first degree relatives of subjects in Arm 1.
559781|NCT00108303|P1|Participant Flow|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia or schizoaffective disorder.
559782|NCT00108303|O3|Outcome|Controls|Persons who are not relatives of persons with schizophrenia and do not have schizophrenia themselves.
559783|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are relatives of probands in Group 1.
559784|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who meet DSM-IV diagnostic criteria for schizophrenia.
559785|NCT00108303|O3|Outcome|Controls|Persons who do not have schizophrenia themselves and whose relatives do not have schizophrenia
559786|NCT00108303|O2|Outcome|Schizophrenia Relatives|Persons who are siblings or children of someone with schizophrenia
559787|NCT00108303|O1|Outcome|Schizophrenia Probands|Persons who have schizophrenia as determined by diagnosis
559788|NCT00108303|O1|Outcome|Group 1|Subjects who receive genetic study.
559789|NCT00108303|E3|Reported Event|Controls|Controls who do not have personal or family history of schizophrenia
559790|NCT00108303|E2|Reported Event|Schizophrenia Relatives|Schizophrenia relatives who siblings or children of persons with schizophrenia
559791|NCT00108303|E1|Reported Event|Schizophrenia Probands|Schizophrenia probands as diagnosed as having schizophrenia
559792|NCT00108277|B4|Baseline|Total|Total of all reporting groups
559793|NCT00108277|B3|Baseline|Waitlist|"Waitlist~Treatment as usual"
559794|NCT00108277|B2|Baseline|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
559795|NCT00108277|B1|Baseline|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
559796|NCT00108277|P3|Participant Flow|Waitlist|Waitlist Treatment as Usual
559797|NCT00108277|P2|Participant Flow|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2"
559798|NCT00108277|P1|Participant Flow|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2"
559799|NCT00108277|O3|Outcome|Waitlist|Waitlist Treatment as usual
559800|NCT00108277|O2|Outcome|Lower CO2|"Lower CO2~Breathing Training- Lower CO2: while breathing 9 breaths per minute, patients are instructed to lower CO2"
559801|NCT00108277|O1|Outcome|Raise CO2|"Raise CO2~Breathing Training-Raise CO2: while breathing 9 breaths per minute, patients are instructed to raise CO2"
559802|NCT00108277|E3|Reported Event|Waitlist|Treatment as usual
559803|NCT00108277|E2|Reported Event|Lower CO2|Breathing Training- Lower CO2: while breathing 9 minutes per minute, patients are instructed to lower CO2
559804|NCT00108277|E1|Reported Event|Raise CO2|Breathing Training-Raise CO2: while breathing 9 minutes per minute, patients are instructed to raise CO2
559805|NCT00108160|B3|Baseline|Total|Total of all reporting groups
559806|NCT00108160|B2|Baseline|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Placebo Group).
559807|NCT00108160|B1|Baseline|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months (Treatment Group).
559808|NCT00108160|P2|Participant Flow|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559809|NCT00108160|P1|Participant Flow|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559810|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment [Placebo]|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559811|NCT00108160|O1|Outcome|Mupirocin Ointment [Treatment]|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559812|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559813|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559814|NCT00108160|O2|Outcome|Polyethylene Glycol Ointment (Placebo)|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559815|NCT00108160|O1|Outcome|Mupirocin Ointment (Treatment)|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559816|NCT00108160|E2|Reported Event|Polyethylene Glycol Ointment|Polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559817|NCT00108160|E1|Reported Event|Mupirocin Ointment|Mupirocin 2% in polyethylene glycol (PEG) ointment applied topically to nares and/or wounds for 14 days every 3 months for up to 18 months.
559818|NCT00108082|B4|Baseline|Total|Total of all reporting groups
560039|NCT00107042|O2|Outcome|Hispanic|Subjects who reported they were of Hispanic ethnicity.
559819|NCT00108082|B3|Baseline|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559820|NCT00108082|B2|Baseline|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559821|NCT00108082|B1|Baseline|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559822|NCT00108082|P3|Participant Flow|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559823|NCT00108082|P2|Participant Flow|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559824|NCT00108082|P1|Participant Flow|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559825|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559826|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559827|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559828|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559829|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559830|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559831|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559832|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559833|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559834|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559835|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559836|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559837|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559838|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559839|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559840|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559841|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559842|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559843|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559844|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559845|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559846|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559847|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559848|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559849|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559850|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559851|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559852|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559853|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559854|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559855|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559856|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559857|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559858|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559859|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559860|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559861|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559862|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559863|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559974|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559864|NCT00108082|O3|Outcome|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559865|NCT00108082|O2|Outcome|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559866|NCT00108082|O1|Outcome|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559867|NCT00108082|E3|Reported Event|Lisinopril|Lisinopril 10 to 40 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559868|NCT00108082|E2|Reported Event|Atenolol|Atenolol 50 to 100 mg OD plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study.
559869|NCT00108082|E1|Reported Event|Carvedilol CR|Carvedilol controlled release (CR) 20 to 80 mg once daily (OD) plus lisinopril 20 mg OD. Participants were titrated from the starting dosage to higher dosages until their blood pressure was controlled. Participants continued to receive lisinopril 20 mg OD throughout the study. (In the protocol, carvedilol CR was referred to as carvedilol modified-release [MR].)
559870|NCT00108069|B3|Baseline|Total|Total of all reporting groups
559871|NCT00108069|B2|Baseline|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559872|NCT00108069|B1|Baseline|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559873|NCT00108069|P2|Participant Flow|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559874|NCT00108069|P1|Participant Flow|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559875|NCT00108069|O6|Outcome|Total|Total number of participants.
559876|NCT00108069|O5|Outcome|Grade 5|Death related to adverse event
559877|NCT00108069|O4|Outcome|Grade 4|Life-threatening or disabling adverse event
559878|NCT00108069|O3|Outcome|Grade 3|Severe adverse event
559879|NCT00108069|O2|Outcome|Grade 2|Moderate adverse event
559880|NCT00108069|O1|Outcome|Grade 1|Mild adverse event
559881|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559882|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559883|NCT00108069|O2|Outcome|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559884|NCT00108069|O1|Outcome|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559885|NCT00108069|E2|Reported Event|AG (Anaplastic Glioma)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559886|NCT00108069|E1|Reported Event|GBM (Glioblastoma Multiforme)|"Bortezomib : intravenous (IV) injection 1.3 mg/m^2 days 3, 6, 10, 13, 24, 27,31,34 on every 6 week cycle~Tamoxifen citrate : oral dose 120 mg twice a day, every day"
559887|NCT00107991|B1|Baseline|Etanercept|50 mg/week subcutaneously
559888|NCT00107991|P1|Participant Flow|Etanercept|50 mg/week subcutaneously
559889|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
559890|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
559891|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
559892|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
559893|NCT00107991|O1|Outcome|Etanercept|50 mg/week subcutaneously
559894|NCT00107991|E1|Reported Event|Etanercept|50 mg/week subcutaneously
559895|NCT00107978|B3|Baseline|Total|Total of all reporting groups
559896|NCT00107978|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
559897|NCT00107978|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
559898|NCT00107978|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
559899|NCT00107978|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
559900|NCT00107978|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
559901|NCT00107978|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
559975|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559902|NCT00107978|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gm every 12 hours. The maximum allowable treatment period was 14 days.
559903|NCT00107978|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
559904|NCT00107952|B3|Baseline|Total|Total of all reporting groups
559905|NCT00107952|B2|Baseline|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
559906|NCT00107952|B1|Baseline|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
559907|NCT00107952|P2|Participant Flow|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
559908|NCT00107952|P1|Participant Flow|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
559909|NCT00107952|O2|Outcome|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
559910|NCT00107952|O1|Outcome|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
559911|NCT00107952|E2|Reported Event|Vancomycin|Patients with Gram-positive hospital acquired pneumonia (HAP)(primarily due to MRSA) were randomized to receive vancomycin 1 Gm IV administered every 12 hrs.
559912|NCT00107952|E1|Reported Event|Telavancin|Patients with Gram-positive hospital acquired pneumonia (HAP) (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV every 24 hrs.
559913|NCT00107536|B1|Baseline|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559914|NCT00107536|P1|Participant Flow|Lapatinib|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559915|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559916|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559917|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559918|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559919|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559920|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559921|NCT00107536|O1|Outcome|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559922|NCT00107536|E1|Reported Event|Arm I|"Patients receive oral lapatinib ditosylate once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~lapatinib ditosylate~laboratory biomarker analysis: Correlative studies"
559923|NCT00107380|B1|Baseline|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
559924|NCT00107380|P1|Participant Flow|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
559925|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
559926|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177.
559927|NCT00107380|O1|Outcome|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
559928|NCT00107380|E1|Reported Event|R-CHOP + I-131-tositumomab|Patients receive cyclophosphamide 750 mg/m^2 IV over 15 minutes, doxorubicin 50 mg/m^2 IV, and vincristine IV on days 1, 22, 43, 64, 85, 106, 127, and 148. Patients also receive oral prednisone 100 mg daily on days 1-5, 22-26, 43-47, 64-68, 85-89, 106-110, 127-131, and 148-152; rituximab 375 mg/m^2 IV on days 1, 22, 43, 64, 85, and 106; unlabeled anti-B1 antibody 450 mg/m^2 IV and dosimetric dose 35 mg IV over 20 minutes on day 170, and unlabeled anti-B1 antibody 450 mg IV and therapeutic dose 35mg IV over 20 minutes on day 177
559929|NCT00107315|B1|Baseline|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559930|NCT00107315|P1|Participant Flow|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559931|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559932|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559933|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559934|NCT00107315|O1|Outcome|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559935|NCT00107315|E1|Reported Event|Combination of Capecitabine and Bevacizumab|Patients received 1500 mg/m2/dose of capecitabine twice daily×7 days and bevacizumab at 5 mg/kg on day 1, in 2 week-cycles.
559936|NCT00107276|B1|Baseline|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
559937|NCT00107276|P1|Participant Flow|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
559938|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|
559939|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
559940|NCT00107276|O1|Outcome|Cyclophosphamide and Capecitabine|cyclophosphamide orally days 1-14 and capecitabine orally days 15-21 for 8 cycles of 21 days each
559941|NCT00107276|E1|Reported Event|Cyclophosphamide and Capecitabine|
559942|NCT00107198|B1|Baseline|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559943|NCT00107198|P1|Participant Flow|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559944|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559945|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
560029|NCT00107042|O1|Outcome|Ever Smoked Cigarettes: NO|Subjects who have never smoked cigarettes
559946|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559947|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559948|NCT00107198|O1|Outcome|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559949|NCT00107198|E1|Reported Event|Surgery or Combination Chemotherapy, With/Without Radiotherapy|"Patients receive doxorubicin hydrochloride 50 mg/m2 IV over 10-30 minutes and cyclophosphamide 800 mg/mg2 IV over 1 hour on day 1, vincristine sulfate 1.4 mg/m2 IV (2.8 mg maximum) over 1 minute on days 1 and 8, and prednisone 40 mg/m2/day PO or IV two or three times daily on days 1-7. Treatment repeats every 21 days for 3 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve CR after 3 courses of therapy proceed to follow-up. Patients who do not achieve a CR proceed to involved-field radiation therapy (IFRT).~IFRT: Beginning within 3 weeks after completion of combination chemotherapy, patients undergo IFRT once daily, 5 days a week for 2.8 weeks (14 treatments).~doxorubicin hydrochloride: Given IV~conventional surgery: Undergo surgery~cyclophosphamide: Given IV~prednisone: Given IV or PO~vincristine sulfate: Given IV~radiation therapy: Undergo IFRT"
559950|NCT00107172|B3|Baseline|Total|Total of all reporting groups
559951|NCT00107172|B2|Baseline|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559952|NCT00107172|B1|Baseline|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559953|NCT00107172|P2|Participant Flow|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559954|NCT00107172|P1|Participant Flow|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559955|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559956|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559957|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559958|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559959|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559960|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559961|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559962|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559963|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559964|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559965|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559966|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559967|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559968|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559969|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559970|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559971|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559972|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559973|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559976|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559977|NCT00107172|O2|Outcome|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559978|NCT00107172|O1|Outcome|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559979|NCT00107172|E2|Reported Event|Arm B (SR + BX)|Patients undergo sublobar resection plus brachytherapy (SR + BX)
559980|NCT00107172|E1|Reported Event|Arm A (SR)|Patients undergo open or thoracoscopic sublobar resection (SR) comprising either a wedge resection or anatomical segmentectomy.
559981|NCT00107120|B3|Baseline|Total|Total of all reporting groups
559982|NCT00107120|B2|Baseline|Placebo|Once daily oral administration of placebo tablets
559983|NCT00107120|B1|Baseline|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559984|NCT00107120|P2|Participant Flow|Placebo|Once daily oral administration of placebo tablets
559985|NCT00107120|P1|Participant Flow|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559986|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
559987|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559988|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
559989|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559990|NCT00107120|O2|Outcome|Placebo|Once daily oral administration of placebo tablets
559991|NCT00107120|O1|Outcome|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559992|NCT00107120|E2|Reported Event|Placebo|Once daily oral administration of placebo tablets
559993|NCT00107120|E1|Reported Event|Escitalopram|Once daily oral administration of escitalopram tablets - 1 tablet (10mg) for the first three weeks, then 1 tablet (10mg or 20mg) depending on therapeutic response and tolerability.
559994|NCT00107042|B3|Baseline|Total|Total of all reporting groups
559995|NCT00107042|B2|Baseline|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
559996|NCT00107042|B1|Baseline|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
559997|NCT00107042|P2|Participant Flow|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
559998|NCT00107042|P1|Participant Flow|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
559999|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560000|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560001|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560002|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560003|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560004|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560005|NCT00107042|O1|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560006|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560007|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560008|NCT00107042|O2|Outcome|Ever Used Drugs Not Prescribed: YES|Subjects who have used drugs that were not prescribed.
560009|NCT00107042|O1|Outcome|Ever Used Drugs Not Prescribed: NO|Subjects who have never used drugs that were not prescribed.
560010|NCT00107042|O2|Outcome|Ever Smoked Marijuana: YES|Subjects who have smoked marijuana
560011|NCT00107042|O1|Outcome|Ever Smoked Marijuana: NO|Subjects who have never smoked marijuana
560012|NCT00107042|O2|Outcome|Ever Drank Alcohol: YES|Subjects who have drank alcohol
560013|NCT00107042|O1|Outcome|Ever Drank Alcohol: NO|Subjects who have never drank alcohol
560014|NCT00107042|O3|Outcome|>= 6 Female Sex Partners|Male and female subjects who have had 6 or more lifetime female sex partners
560015|NCT00107042|O2|Outcome|1-5 Female Sex Partners|Male and female Subjects who have had 1 - 5 lifetime female sex partners
560016|NCT00107042|O1|Outcome|0 Female Sex Partners|Male and female subjects who have never had a female sex partner
560017|NCT00107042|O3|Outcome|>= 6 Male Sex Partners|Male and female subjects who have had 6 or more lifetime male sex partners
560018|NCT00107042|O2|Outcome|1-5 Male Sex Partners|Male and female subjects who have had 1 - 5 lifetime male sex partners
560019|NCT00107042|O1|Outcome|0 Male Sex Partners|Male and female subjects who have never had a male sex partner
560020|NCT00107042|O3|Outcome|>= 6 Sex Partners|Subjects who have had 6 or more lifetime sex partners
560021|NCT00107042|O2|Outcome|1 - 5 Sex Partners|Subjects who have had 1 - 5 lifetime sex partners
560022|NCT00107042|O1|Outcome|0 Sex Partners|Subjects who have never had a sex partner
560023|NCT00107042|O3|Outcome|15-17 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 15 and 17, inclusive
560024|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects who reported they first had anal or vaginal sex because they wanted to between the ages of 12 and 14, inclusive
560025|NCT00107042|O1|Outcome|Never|Subjects who reported they never had anal or vaginal sex because they wanted to.
560026|NCT00107042|O2|Outcome|Gay (Homosexual), Bi (Bisexual), Not Sure or Undecided|Subjects who were either gay (homosexual), bisexual, not sure or undecided.
560027|NCT00107042|O1|Outcome|Straight (Heterosexual)|Subjects who were straight (heterosexual)
560028|NCT00107042|O2|Outcome|Ever Smoked Cigarettes: YES|Subjects who have smoked cigarettes
571844|NCT00063635|E3|Reported Event|Placebo|Matching placebo
560043|NCT00107042|O2|Outcome|12-14 Years of Age|Subjects between the ages of 12 and 14 years, inclusive
560044|NCT00107042|O1|Outcome|15-17 Years of Age|Subjects between the ages of 15 and 17 years, inclusive
560045|NCT00107042|O2|Outcome|Baltimore|Clinical site where subjects were enrolled.
560046|NCT00107042|O1|Outcome|Other Sites|All other clinical sites (besides the Baltimore site) where subjects were enrolled.
560047|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560048|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Wk 24
560049|NCT00107042|O1|Outcome|All Participants|All participants who had a week 28 hepatitis B antibody titer and the week 28 visit window was no more than 8 weeks after the second vaccination (per protocol). Participants were vaccinated at Week 0 and Week 24 with either Recombivax or Twinrix.
560050|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560051|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560052|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560053|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560054|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560055|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560056|NCT00107042|O2|Outcome|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560057|NCT00107042|O1|Outcome|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560058|NCT00107042|E2|Reported Event|Twinrix|Experimental: 1st dose at Week 0, 2nd dose at Week 24
560059|NCT00107042|E1|Reported Event|Recombivax|Active Comparator: 1st dose at Week 0, 2nd dose at Week 24
560060|NCT00106964|B4|Baseline|Total|Total of all reporting groups
560061|NCT00106964|B3|Baseline|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560062|NCT00106964|B2|Baseline|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560063|NCT00106964|B1|Baseline|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560064|NCT00106964|P3|Participant Flow|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560065|NCT00106964|P2|Participant Flow|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560066|NCT00106964|P1|Participant Flow|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560067|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560068|NCT00106964|O2|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560069|NCT00106964|O1|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560070|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560071|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560072|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560073|NCT00106964|O3|Outcome|3: Twindrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560074|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560075|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560076|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
560077|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
560078|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was definitely related to study drug as determined by the Site Investigator.
560079|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|Twinrix 20 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
560080|NCT00106964|O2|Outcome|2: Engerix 40 mcg|Engerix 40 mcg vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
560081|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Number of participants with a Grade 1 event that was probably or possibly related to study drug as determined by the Site Investigator.
560082|NCT00106964|O3|Outcome|3: Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560083|NCT00106964|O2|Outcome|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560084|NCT00106964|O1|Outcome|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560085|NCT00106964|E3|Reported Event|3. Twinrix 20 mcg|20 mcg of Twinrix. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560086|NCT00106964|E2|Reported Event|2: Engerix 40 mcg|40 mcg of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560087|NCT00106964|E1|Reported Event|1: Engerix 20 mcg|Standard dose (20 mcg) of Hepatitis B vaccine. Dose #1 at Entry; Dose #2 at Week 4; Dose #3 at Week 24.
560088|NCT00106938|B3|Baseline|Total|Total of all reporting groups
560089|NCT00106938|B2|Baseline|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560090|NCT00106938|B1|Baseline|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560091|NCT00106938|P2|Participant Flow|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560092|NCT00106938|P1|Participant Flow|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560093|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560094|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560095|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560096|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560097|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560098|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560099|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560100|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560101|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560102|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560103|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560104|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560105|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560106|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560107|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560108|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560109|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560110|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560111|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560112|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560113|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560114|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560115|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560116|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560117|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560118|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560148|NCT00106639|B3|Baseline|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560119|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560120|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560121|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560122|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560123|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560124|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560125|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560126|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560127|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560128|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560129|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560130|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560131|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560132|NCT00106938|O2|Outcome|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560133|NCT00106938|O1|Outcome|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560134|NCT00106938|E2|Reported Event|CEA Group|"CEA group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560135|NCT00106938|E1|Reported Event|CAS Group|"CAS group: 3:1 ratio of Carotid Artery Stenting (CAS) versus Carotid Endarterectomy (CEA).~Subjects will be followed at 30 days, six (6), and 12 months post-procedure, and annually for four (4) additional years."
560136|NCT00106704|B3|Baseline|Total|Total of all reporting groups
560137|NCT00106704|B2|Baseline|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560138|NCT00106704|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560139|NCT00106704|P2|Participant Flow|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560140|NCT00106704|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560141|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560142|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560143|NCT00106704|O2|Outcome|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560144|NCT00106704|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560145|NCT00106704|E2|Reported Event|Placebo/ Pioglitazone|The Placebo group includes data from patients randomized to receive treatment with placebo to sitagliptin oral tablets q.d. with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560146|NCT00106704|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) with glimepiride (≥4 mg/day) alone or in combination with metformin (≥1500 mg/day).
560147|NCT00106639|B4|Baseline|Total|Total of all reporting groups
572550|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
560149|NCT00106639|B2|Baseline|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560150|NCT00106639|B1|Baseline|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560151|NCT00106639|P3|Participant Flow|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560152|NCT00106639|P2|Participant Flow|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560153|NCT00106639|P1|Participant Flow|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560154|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560155|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560156|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560157|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560158|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560159|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560160|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560161|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560162|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560163|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560164|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560165|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560166|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560167|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560168|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560169|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560170|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560171|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560172|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560173|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560174|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560175|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560176|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560177|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560178|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560179|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560180|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560181|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560182|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560183|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560184|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560185|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560186|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560187|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560188|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560189|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560190|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560191|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560192|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560193|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560194|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560195|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560196|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560197|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560198|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560199|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560200|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560201|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560202|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560203|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560204|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560205|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560206|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560207|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560208|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560209|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560210|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560211|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560212|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560213|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560214|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560215|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560216|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560217|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560218|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560219|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560220|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560221|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560222|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560223|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560224|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560225|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560226|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560227|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560228|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560229|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560230|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560231|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560232|NCT00106639|O1|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560233|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560234|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560235|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560236|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560237|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560238|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560239|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560240|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560241|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560242|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560243|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560244|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560245|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560246|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560247|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560248|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560249|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560250|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560251|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560252|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560253|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560254|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560255|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560256|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560257|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560258|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560259|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560260|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560261|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560262|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560263|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560264|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560265|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560266|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560267|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560268|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560269|NCT00106639|O3|Outcome|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560270|NCT00106639|O2|Outcome|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560271|NCT00106639|O1|Outcome|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560272|NCT00106639|E3|Reported Event|Tacrolimus|Tacrolimus 0.5 mg or 1 mg capsule administered orally as per local clinical practice up to Month 6.
560273|NCT00106639|E2|Reported Event|CP-690,550 30 mg|CP-690,550 30 mg tablet orally twice daily up to Month 6.
560274|NCT00106639|E1|Reported Event|CP-690,550 15 mg|CP-690,550 15 milligram (mg) tablet orally twice daily up to Month 6.
560275|NCT00106626|B5|Baseline|Total|Total of all reporting groups
560276|NCT00106626|B4|Baseline|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
560277|NCT00106626|B3|Baseline|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
560278|NCT00106626|B2|Baseline|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
560279|NCT00106626|B1|Baseline|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
560280|NCT00106626|P4|Participant Flow|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
560281|NCT00106626|P3|Participant Flow|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
560282|NCT00106626|P2|Participant Flow|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
560283|NCT00106626|P1|Participant Flow|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
560284|NCT00106626|O4|Outcome|Cohort D - Vorinostat QD + Pemetrexed|"Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed~Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed"
560285|NCT00106626|O3|Outcome|Cohort C - Vorinostat BID + Pemetrexed|"Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed~Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed~Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed"
560286|NCT00106626|O2|Outcome|Cohort B - Vorinostat QD + Pemetrexed + Cisplatin|"Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin~Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin"
560287|NCT00106626|O1|Outcome|Cohort A - Vorinostat BID + Pemetrexed + Cisplatin|"Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin~Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin"
560288|NCT00106626|O9|Outcome|Dose Level D.2|(Cohort D) Dose level D.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed
560289|NCT00106626|O8|Outcome|Dose Level D.1|(Cohort D) Dose level D.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed
560290|NCT00106626|O7|Outcome|Dose Level C.3|(Cohort C) Dose level C.3 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days repeated weekly + Pemetrexed
560291|NCT00106626|O6|Outcome|Dose Level C.2|(Cohort C) Dose level C.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first two weeks, one week off + Pemetrexed
560292|NCT00106626|O5|Outcome|Dose Level C.1|(Cohort C) Dose level C.1 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed
561171|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
560293|NCT00106626|O4|Outcome|Dose Level B.2|(Cohort B) Dose level B.2 - Vorinostat 400 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
560294|NCT00106626|O3|Outcome|Dose Level B.1|(Cohort B) Dose level B.1 - Vorinostat 300 mg once daily (QD) for 7 days + Pemetrexed + Cisplatin
560295|NCT00106626|O2|Outcome|Dose Level A.2|(Cohort A) Dose level A.2 - Vorinostat 300 mg twice daily (BID) for 3 consecutive days out of 7 days in first week, two weeks off + Pemetrexed + Cisplatin
560296|NCT00106626|O1|Outcome|Dose Level A.1|(Cohort A) Dose level A.1 - Vorinostat 200 mg twice daily (BID) for 14 days out of 3 weeks + Pemetrexed + Cisplatin
560297|NCT00106535|B4|Baseline|Total|Total of all reporting groups
560298|NCT00106535|B3|Baseline|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560299|NCT00106535|B2|Baseline|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560300|NCT00106535|B1|Baseline|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560301|NCT00106535|P4|Participant Flow|All Tocilizumab Exposure + MTX|All tocilizumab (TCZ) exposure + methotrexate (MTX) group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either Placebo, Tocilizumab 4 mg/kg or Tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received 8 mg/kg IV every 4 weeks.
560302|NCT00106535|P3|Participant Flow|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
560303|NCT00106535|P2|Participant Flow|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension (LTE) period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
560304|NCT00106535|P1|Participant Flow|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly for 52 weeks. From Week 16 participants with < 20% improvement in swollen and tender joints counts were eligible for escape therapy with tocilizumab. After Week 52 participants were able to switch to open label treatment with tocilizumab 8 mg/kg every 4 weeks for 12 months in year 2 (except patients who had a >70% improvement in both swollen and tender joint counts who remained on blinded treatment). Participants who completed year 2 of the study were eligible to enter an optional open-label long-term extension period (Year 3 to 5) and received Tocilizumab 8 mg/kg every 4 weeks.
560305|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560306|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560307|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560308|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560309|NCT00106535|O2|Outcome|Tocilizumab + Methotrexate|All participants received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560310|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560311|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560312|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
561172|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
560313|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560314|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560315|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560316|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560317|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560318|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560319|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560320|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560321|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560322|NCT00106535|O1|Outcome|All Tocilizumab Exposure + MTX|All tocilizumab exposure group included all participants who received at least one dose of tocilizumab during the placebo controlled core study or the long term extension period plus MTX 10-25 mg (oral or parenteral) weekly. Participants received either: placebo, tocilizumab 4 mg/kg or tocilizumab 8 mg/kg in the 2 year placebo controlled core treatment phase. In the extension 3 to 5 year period, all participants received tocilizumab 8 mg/kg IV every 4 weeks.
560323|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560324|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560325|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560326|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560327|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560328|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560329|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560330|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560331|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560332|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560333|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560334|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560335|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560336|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560337|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560338|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560339|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560340|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560341|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560342|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560343|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560344|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560345|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560346|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560347|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560348|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560349|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560350|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560351|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560352|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560353|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560354|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560355|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560356|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560357|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560358|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560359|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560360|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560361|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560362|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560363|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560364|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560365|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560366|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560367|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560368|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560369|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560370|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560371|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560372|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560373|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560374|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560375|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560376|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560377|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560378|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560379|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560380|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
561173|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
560381|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560382|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560383|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560384|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560385|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560386|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560387|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560388|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560389|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560390|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560391|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560392|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560393|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560394|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560395|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560396|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560397|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560398|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560399|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560400|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560401|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560402|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560403|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560404|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560405|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560406|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560407|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560408|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560409|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560410|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560411|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560412|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560413|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560414|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560415|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560416|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560417|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560418|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560419|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560420|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560421|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560422|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560423|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560424|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
572551|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
560425|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560426|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560427|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560428|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560429|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560430|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560431|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560432|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560433|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560434|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560435|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560436|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560437|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560438|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560439|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560440|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560441|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560442|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560443|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560444|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560445|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560446|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560447|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560448|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560449|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560450|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560451|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560452|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560453|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560454|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560455|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560456|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560457|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560458|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560459|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560460|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560461|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560462|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560463|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560464|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560465|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560466|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560467|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560468|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
561174|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
560469|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560470|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560471|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560472|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560473|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560474|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560475|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560476|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560477|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560478|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560479|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560480|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560481|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560482|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560483|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560484|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560485|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560486|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560487|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560488|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560489|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560490|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560491|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560492|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560493|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560494|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560495|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560496|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560497|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560498|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560499|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560500|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560501|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560502|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560503|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560504|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560505|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560506|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560507|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560508|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560509|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560510|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560511|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560512|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
572552|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
560513|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560514|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560515|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560516|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560517|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560518|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560519|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560520|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560521|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560522|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560523|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560524|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560525|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560526|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560527|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560528|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560529|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560530|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560531|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560532|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560533|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560534|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560535|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560536|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560537|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560538|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560539|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560540|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560541|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560542|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560543|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560544|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560545|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560546|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560547|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560548|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560549|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560550|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560551|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560552|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560553|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560554|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560555|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560556|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
561175|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
560557|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560558|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560559|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly
560560|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560561|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560562|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560563|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560564|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560565|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560566|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560567|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560568|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560569|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560570|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560571|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560572|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560573|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560574|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560575|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560576|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560577|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560578|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560579|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560580|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560581|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560582|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560583|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560584|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560585|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560586|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560587|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560588|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560589|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560590|NCT00106535|O3|Outcome|Tocilizumab 8 mg/kg + Methotrexate|Tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560591|NCT00106535|O2|Outcome|Tocilizumab 4 mg/kg + Methotrexate|Tocilizumab 4 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly.
560592|NCT00106535|O1|Outcome|Placebo + Methotrexate|Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.
560593|NCT00106535|E3|Reported Event|All Tocilizumab 8 mg/kg + Methotrexate|"All participants who received tocilizumab 8 mg/kg IV every 4 weeks plus MTX 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 8mg + MTX = 3797.94 PY."
560594|NCT00106535|E2|Reported Event|All Tocilizumab 4 mg/kg + Methotrexate|"All participants who received tocilizumab (TCZ) 4 mg/kg IV every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly during the study.~Total exposure TCZ 4mg + MTX = 580.99 PY."
560595|NCT00106535|E1|Reported Event|Placebo + Methotrexate|"Placebo intravenously (IV) every 4 weeks plus methotrexate (MTX) 10-25 mg (oral or parenteral) weekly.~Total Exposure Placebo + MTX = 282.36 patient-years (PY)."
560596|NCT00106431|B1|Baseline|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560622|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560597|NCT00106431|P1|Participant Flow|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560598|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560599|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560600|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560601|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560602|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560603|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560604|NCT00106431|O1|Outcome|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560605|NCT00106431|E1|Reported Event|Romidepsin|Regimen was 14 mg/m2 IV over a 4-hour period on Days 1, 8, and 15 of a 28-day cycle. The protocol included 6 cycles of treatment; responding patients and patients who achieved at least Stable Disease (SD) had the option of continuing treatment beyond 6 cycles at the discretion of the Investigator and based on local regulations.
560606|NCT00106392|B3|Baseline|Total|Total of all reporting groups
560607|NCT00106392|B2|Baseline|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560608|NCT00106392|B1|Baseline|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560609|NCT00106392|P2|Participant Flow|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560610|NCT00106392|P1|Participant Flow|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560611|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560612|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560613|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560614|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560615|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560616|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560617|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560618|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560619|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560620|NCT00106392|O1|Outcome|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560621|NCT00106392|O2|Outcome|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
561176|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
560623|NCT00106392|E2|Reported Event|Placebo|Preoperatively: Matching placebo oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Matching placebo oral daily at time of hospital discharge through 6 months of follow up.
560624|NCT00106392|E1|Reported Event|Tacrolimus|Preoperatively: Tacrolimus 2 mg oral daily from 4 to 10 days prior to surgery through hospital discharge; Postoperatively: Tacrolimus 3 mg oral daily at time of hospital discharge through 6 months of follow up.
560625|NCT00106353|B3|Baseline|Total|Total of all reporting groups
560626|NCT00106353|B2|Baseline|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560627|NCT00106353|B1|Baseline|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
560628|NCT00106353|P7|Participant Flow|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560629|NCT00106353|P6|Participant Flow|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560630|NCT00106353|P5|Participant Flow|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560631|NCT00106353|P4|Participant Flow|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560632|NCT00106353|P3|Participant Flow|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560633|NCT00106353|P2|Participant Flow|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560634|NCT00106353|P1|Participant Flow|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligram per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560635|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560636|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
560637|NCT00106353|O2|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560638|NCT00106353|O1|Outcome|Part 1|Participants received temsirolimus intravenously once weekly over 60 minutes infusion in dose escalation schemes of 10 mg/m^2, 25 mg/m^2, 75 mg/m^2 and 150 mg/m^2.
560639|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560640|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560641|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560642|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560643|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560644|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
560645|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560646|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560647|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560648|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560649|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560650|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560651|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560652|NCT00106353|O1|Outcome|Part 2|Participants with high-grade glioma, neuroblastoma and rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion..
560653|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560654|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560655|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560656|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560657|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560658|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560659|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
561177|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
560660|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560661|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560662|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560663|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560664|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560665|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560666|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560667|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560668|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560669|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560670|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560671|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560672|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560673|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560674|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560675|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560676|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560677|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560678|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560679|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560680|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560681|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560682|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560683|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
560684|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560685|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560686|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560687|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560688|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560689|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560690|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560691|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560692|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560693|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560694|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560695|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560696|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560697|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560698|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560699|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560700|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560849|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560701|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560702|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560703|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560704|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560705|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560706|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560707|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560708|NCT00106353|O3|Outcome|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560709|NCT00106353|O2|Outcome|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560710|NCT00106353|O1|Outcome|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560711|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560712|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560713|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560714|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560715|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560716|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560717|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560718|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560719|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560720|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560721|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560722|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560723|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560724|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560725|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560726|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560727|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560728|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560729|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560730|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560731|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560732|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560733|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560734|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560735|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560736|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560737|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560738|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560739|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560740|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560741|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560742|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560743|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560744|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560745|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560746|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560747|NCT00106353|O4|Outcome|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560748|NCT00106353|O3|Outcome|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560749|NCT00106353|O2|Outcome|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560750|NCT00106353|O1|Outcome|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 milligrams per square meter (mg/m^2) administered intravenously once weekly over 60 minutes infusion.
560751|NCT00106353|E7|Reported Event|Rhabdomyosarcoma: Part 2|Participants with rhabdomyosarcoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560752|NCT00106353|E6|Reported Event|Neuroblastoma: Part 2|Participants with neuroblastoma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560753|NCT00106353|E5|Reported Event|High-grade Glioma: Part 2|Participants with high-grade glioma were administered temsirolimus 75 mg/m^2 intravenously once weekly over 60 minutes infusion.
560754|NCT00106353|E4|Reported Event|Temsirolimus 150 mg/m^2: Part 1|Temsirolimus 150 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
560755|NCT00106353|E3|Reported Event|Temsirolimus 75 mg/m^2: Part 1|Temsirolimus 75 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
560756|NCT00106353|E2|Reported Event|Temsirolimus 25 mg/m^2: Part 1|Temsirolimus 25 mg/m^2 intravenously administered once weekly over 60 minutes infusion.
560757|NCT00106353|E1|Reported Event|Temsirolimus 10 mg/m^2: Part 1|Temsirolimus 10 mg/m^2 administered intravenously once weekly over 60 minutes infusion.
560758|NCT00106249|B3|Baseline|Total|Total of all reporting groups
560759|NCT00106249|B2|Baseline|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560760|NCT00106249|B1|Baseline|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560761|NCT00106249|P2|Participant Flow|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560762|NCT00106249|P1|Participant Flow|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560763|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560764|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560765|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560766|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560767|NCT00106249|O2|Outcome|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560768|NCT00106249|O1|Outcome|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560769|NCT00106249|E2|Reported Event|Sham rTMS|"Placebo Repetitive Transcranial Magnetic Stimulation (rTMS)~Sham: Sham rTMS will be administered using the Magstim Sham coil which contains a mu-metal shield that diverts the majority of the magnetic flux such that a minimal (less than 3%) magnetic field is delivered to the cortex in order to provoke a subjective sensation similar to that obtained with the real stimulation but without inducing significant cortical stimulation."
560799|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560770|NCT00106249|E1|Reported Event|Active rTMS|"Active Repetitive Transcranial Magnetic Stimulation (rTMS)~Repetitive Transcranial Magnetic Stimulation (rTMS): Stimulus train of 30 min duration, 1Hz frequency, and 110% of the motor threshold intensity given once a day, 5 days a week, for 4 weeks by Magstim SuperRapid Magnetic Stimulator."
560771|NCT00106184|B3|Baseline|Total|Total of all reporting groups
560772|NCT00106184|B2|Baseline|Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560773|NCT00106184|B1|Baseline|Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560774|NCT00106184|P2|Participant Flow|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560775|NCT00106184|P1|Participant Flow|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA (Body Surface Area) up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560776|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560777|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560778|NCT00106184|O2|Outcome|Treatment Group B (Rituximab Wks 8 and 9)|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560779|NCT00106184|O1|Outcome|Treatment Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560780|NCT00106184|O2|Outcome|Group B (Rituximab Wks 8 and 9)|"Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560781|NCT00106184|O1|Outcome|Group A (Rituximab Wks 0 and 1)|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1~Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560782|NCT00106184|E2|Reported Event|Treatment Group B|"Subjects received placebo at Weeks 0 and 1 followed by rituximab at Weeks 8 and 9 (Treatment Group B)~Group B - intravenous rituximab 750mg/m2 BSA up to a maximum does of 1 gram at Weeks 8 and 9~Treatment Group B: placebo infusion at Weeks 0 and 1"
560783|NCT00106184|E1|Reported Event|Treatment Group A|"Subjects received rituximab at Weeks 0 and 1 followed by placebo at Weeks 8 and 9 (Treatment Group A)~Rituximab : Treatment Group A - intravenous rituximab 750mg/m2 BSA up to a maximum dose of 1 gram at Weeks 0 and 1 Placebo : Treatment Group A: placebo infusion at Weeks 8 and 9"
560784|NCT00106119|B1|Baseline|Entire Study Population|Includes groups randomized to receive Levothyroxine first and Liothyronine first.
560785|NCT00106119|P2|Participant Flow|Levothyroxine First, Then Liothyronine|Levothyroxine (dose of 5, 10, or 33 mcg) in first intervention period and Liothyronine (dose of 2.5, 10, or 16 mcg) in second intervention period (after washout period)
560786|NCT00106119|P1|Participant Flow|Liothyronine First, Then Levothyroxine|Liothyronine (dose of 2.5, 10, or 16 mcg) in first intervention period and Levothyroxine (dose of 5, 10, or 33 mcg) in second intervention period (after washout period)
560787|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560788|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560789|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560790|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560791|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560792|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560793|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention ArmArm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560794|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560795|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560796|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560797|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560798|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560848|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560800|NCT00106119|O1|Outcome|Liothyronine/Levothyroxine Therapy Intervention Arm|Hypothyroid patients are treated with Levothyroxine and Liothyronine in 2 crossover, randomized phases
560801|NCT00106119|E2|Reported Event|Liothyronine Period|Patients at Liothyronine Period
560802|NCT00106119|E1|Reported Event|Levothyroxine Period|Patients at Levothyroxine Period
560803|NCT00106106|B3|Baseline|Total|Total of all reporting groups
560804|NCT00106106|B2|Baseline|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
560805|NCT00106106|B1|Baseline|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
560806|NCT00106106|P2|Participant Flow|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
560807|NCT00106106|P1|Participant Flow|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
560808|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
560809|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
560810|NCT00106106|O2|Outcome|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
560811|NCT00106106|O1|Outcome|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
560812|NCT00106106|E2|Reported Event|Acamprosate|For subjects randomized to active treatment, the first 3 acamprosate doses were 1332 mg every 8 hours in an attempt to more rapidly achieve active plasma concentrations, followed by 666 mg acamprosate every 8 hours for the remainder of the study.
560813|NCT00106106|E1|Reported Event|Placebo|For subjects randomized to placebo control, placebo doses were given every 8 hours.
560814|NCT00106080|B3|Baseline|Total|Total of all reporting groups
560815|NCT00106080|B2|Baseline|Control|Usual care
560816|NCT00106080|B1|Baseline|Intervention|Audit and feedback
560817|NCT00106080|P2|Participant Flow|Control (Usual Care)|We solicited control patients' preferences but did not deliver study generated summary reports to patients, surrogates or providers.
560818|NCT00106080|P1|Participant Flow|Intervention (Audit and Feedback)|We solicited patients' preferences for health care communication and treatment in order to generate individualized summary reports of patient's preferences. These individualized summaries of patient's preferences regarding communication about end-of-life care and preferences for end-of-life care were used to activate patients, family members, and healthcare providers.
560819|NCT00106080|O2|Outcome|Control|Usual care
560820|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
560821|NCT00106080|O2|Outcome|Control|Usual care
560822|NCT00106080|O1|Outcome|Intervention|Audit and Feedback
560823|NCT00106080|E2|Reported Event|Control|Usual care
560824|NCT00106080|E1|Reported Event|Intervention|Audit and Feedback
560825|NCT00106028|B3|Baseline|Total|Total of all reporting groups
560826|NCT00106028|B2|Baseline|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560827|NCT00106028|B1|Baseline|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560828|NCT00106028|P2|Participant Flow|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560829|NCT00106028|P1|Participant Flow|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560830|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560831|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560832|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560833|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560834|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560835|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560836|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560837|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560838|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560839|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560840|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560841|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560842|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560843|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560844|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560845|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560846|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560847|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560850|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560851|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560852|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560853|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560854|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560855|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560856|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560857|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560858|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560859|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560860|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560861|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560862|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560863|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560864|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560865|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560866|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560867|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560868|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560869|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560870|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560871|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560872|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560873|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560874|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560875|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560876|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560877|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560878|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560879|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560880|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560881|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560882|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560883|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560884|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560885|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560886|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560887|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560888|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560889|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560890|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560891|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560892|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560893|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560894|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560895|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560896|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560897|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560898|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
572553|NCT00056472|E2|Reported Event|Monotherapy|placebo plus olanzapine
560899|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560900|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560901|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560902|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560903|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560904|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560905|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560906|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560907|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560908|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560909|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560910|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560911|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560912|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560913|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560914|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560915|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560916|NCT00106028|O2|Outcome|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560917|NCT00106028|O1|Outcome|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560918|NCT00106028|E4|Reported Event|Years 2 & 3 Risedronate|Years 1-3 Risedronate, Double-Blind Year 1, Open-Label Years 2 & 3
560919|NCT00106028|E3|Reported Event|Years 2 & 3 Placebo-Risedronate|Year 1 Placebo Double-Blind, Years 2 & 3 Open-Label Risedronate
560920|NCT00106028|E2|Reported Event|Risedronate Daily|risedronate tablet, once a day for one year then for two years open label risedronate once a day
560921|NCT00106028|E1|Reported Event|Placebo Daily|placebo tablet, once a day for one year then for two years open label risedronate
560922|NCT00106002|B1|Baseline|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560923|NCT00106002|P1|Participant Flow|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560924|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560925|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560926|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560927|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560928|NCT00106002|O1|Outcome|Pemetrexed|600 mg/m2, intravenous (IV), every 14 days until complete response or disease progression
560929|NCT00106002|E1|Reported Event|Pemetrexed|Pemetrexed
560930|NCT00105989|B1|Baseline|Duloxetine|duloxetine 60-120 mg QD
560931|NCT00105989|P2|Participant Flow|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560932|NCT00105989|P1|Participant Flow|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560933|NCT00105989|O3|Outcome|Duloxetine 120 mg|duloxetine 120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560934|NCT00105989|O2|Outcome|Duloxetine 90 mg|duloxetine 90 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560935|NCT00105989|O1|Outcome|Duloxetine 60 mg|duloxetine 60 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560936|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560937|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560938|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560939|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560940|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560941|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560942|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560943|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560944|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560945|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560946|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560947|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560948|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560949|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560950|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560951|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560952|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560953|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560954|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560955|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560956|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560957|NCT00105989|O1|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560958|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560959|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560960|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560961|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560962|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560963|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560964|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560965|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560966|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560967|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560968|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560969|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560970|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560971|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560972|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560973|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560974|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560975|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560976|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560977|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560978|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560979|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560980|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560981|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560982|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560983|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560984|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560985|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560986|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560987|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560988|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560989|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560990|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560991|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg QD
560992|NCT00105989|O1|Outcome|Duloxetine - Acute|duloxetine 60-120 mg QD
560993|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560994|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
573676|NCT00048724|O2|Outcome|Untreated Control|
560995|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
560996|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
560997|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
560998|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
560999|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561000|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561001|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561002|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561003|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561004|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561005|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561006|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561007|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561008|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561009|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561010|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561011|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561012|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561013|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561014|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561015|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561016|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561017|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561018|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561019|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561020|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561021|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561022|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561023|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561024|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561025|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561026|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561027|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561028|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561029|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561030|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561031|NCT00105989|O2|Outcome|Duloxetine - Continuation Phase|duloxetine 60-120 mg every day (QD) from Week 10 (baseline) to Week 34 (Endpoint)
561032|NCT00105989|O1|Outcome|Duloxetine - Acute Phase|duloxetine 60-120 mg every day (QD) from Week 0 (baseline) to Week 10 (Endpoint)
561033|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561034|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561035|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561036|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561037|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
561038|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561039|NCT00105989|O2|Outcome|Placebo|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by placebo QD, PO for up to 54 weeks.
575296|NCT00041717|E2|Reported Event|Placebo|Placebo : Placebo
561040|NCT00105989|O1|Outcome|Duloxetine|duloxetine 60-120 mg every day (QD), by mouth (PO) for 34 weeks followed by duloxetine 60-120 mg QD, PO for up to 54 weeks.
561041|NCT00105989|E4|Reported Event|Duloxetine 120 mg|Duloxetine 120 mg
561042|NCT00105989|E3|Reported Event|Duloxetine 90 mg|Duloxetine 90 mg
561043|NCT00105989|E2|Reported Event|Duloxetine 60 mg|Duloxetine 60 mg
561044|NCT00105989|E1|Reported Event|Placebo|Placebo
561045|NCT00105534|B3|Baseline|Total|Total of all reporting groups
561046|NCT00105534|B2|Baseline|Vehicle|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
561047|NCT00105534|B1|Baseline|AzaSite|Per protocol population defined as all randomized participants who had administered at least one drop of study drug, who had eye cultures indicating pathogenic bacteria levels as well as the clinical signs of conjunctivitis at Visit 1 and had at least one post first dose clinical assessment.
561048|NCT00105534|P2|Participant Flow|Vehicle|
561049|NCT00105534|P1|Participant Flow|AzaSite|
561050|NCT00105534|O2|Outcome|Vehicle|
561051|NCT00105534|O1|Outcome|AzaSite|
561052|NCT00105534|O2|Outcome|Vehicle|
561053|NCT00105534|O1|Outcome|AzaSite|
561054|NCT00105534|E2|Reported Event|Vehicle|
561055|NCT00105534|E1|Reported Event|AzaSite|
561056|NCT00105482|B3|Baseline|Total|Total of all reporting groups
561057|NCT00105482|B2|Baseline|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561058|NCT00105482|B1|Baseline|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561059|NCT00105482|P2|Participant Flow|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561060|NCT00105482|P1|Participant Flow|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561061|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561062|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561063|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561064|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561065|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561108|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
577126|NCT00006305|B5|Baseline|Total|Total of all reporting groups
561066|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561067|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561068|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561069|NCT00105482|O2|Outcome|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561070|NCT00105482|O1|Outcome|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561071|NCT00105482|E2|Reported Event|Placebo|"Arm 2 (Placebo Comparator) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Placebo Naltrexone 25 mg oral capsule once per day~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561072|NCT00105482|E1|Reported Event|Naltrexone|"Arm 1 (Experimental) = Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + Naltrexone 25 mg oral capsule once per day~Transdermal nicotine replacement : Transdermal nicotine replacement (21 mg for first 6 weeks post-quit then 14 mg for 2 weeks) once per day + naltrexone 25 mg oral capsule once per day~Naltrexone : Drug: Naltrexone 12.5 mg oral capsule once per day for 1 day then 25 mg oral capsule once per day for 27 weeks~Behavioral counseling : Brief behavioral counseling and research assessments are provided for two sessions prior to the quit date and then weekly for two weeks, bi-weekly for a month and every four weeks thereafter."
561073|NCT00105469|B3|Baseline|Total|Total of all reporting groups
561074|NCT00105469|B2|Baseline|Tobramycin|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
561075|NCT00105469|B1|Baseline|AzaSite|"Per protocol population (defined as all randomized~subjects who had administered at least one drop of the appropriate study drug, demonstrated evidence of~pathogenic bacteria levels, presented clinical signs of conjunctivitis at Visit 1, and returned for at least one post-first dose clinical assessment) with last observation carried forward."
561076|NCT00105469|P2|Participant Flow|Tobramycin|
561077|NCT00105469|P1|Participant Flow|AzaSite|
561078|NCT00105469|O2|Outcome|Tobramycin|
561079|NCT00105469|O1|Outcome|AzaSite|
561080|NCT00105469|O2|Outcome|Tobramycin|
561081|NCT00105469|O1|Outcome|AzaSite|
561082|NCT00105469|E2|Reported Event|Tobramycin|
561083|NCT00105469|E1|Reported Event|AzaSite|
561084|NCT00105443|B3|Baseline|Total|Total of all reporting groups
561085|NCT00105443|B2|Baseline|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561086|NCT00105443|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561087|NCT00105443|P4|Participant Flow|B2) Placebo First - Then Open Label Sorafenib Treatment Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2, RG4, and RG5 in the Safety section."
561088|NCT00105443|P3|Participant Flow|B1) Placebo - no Open Label Phase|"Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG2 and RG4 in the Safety section."
561109|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561089|NCT00105443|P2|Participant Flow|A2) Sorafenib (Nexavar, BAY43-9006) - With Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
561090|NCT00105443|P1|Participant Flow|A1) Sorafenib (Nexavar, BAY43-9006) - no Open Label Phase|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data of participants in the arm presented here are reported in Reporting Groups (RG) RG1 and RG3 in the Safety section.
561091|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561092|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561093|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561094|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561095|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561096|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561097|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561098|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561099|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561100|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561101|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561102|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561103|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561104|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561105|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561106|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561107|NCT00105443|O2|Outcome|Placebo|Sorafenib-matching placebo tablets were orally administered twice daily (bid). Follow-up / Open Label phase: Subjects on placebo who chose to switch to sorafenib, received an oral dose of 400 mg (2 x 200 mg tablets) bid; similar to the double-blind study.
561178|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561110|NCT00105443|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily; 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Follow-up / Open Label phase: Subjects on sorafenib who continued the study, continued on the same dose of sorafenib as during the double-blind study.
561111|NCT00105443|E5|Reported Event|Subjects Switching From Placebo to Sorafenib (Open Label Only)|Reporting Group 5 (RG 5): Participants initially randomized to Placebo who switched to Sorafenib in Open Label phase (data after unblinding only, from Feb 09, 2007 until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid). Note: Safety Data presented here include participants listed in Arm B2 of the Participant Flow section.
561112|NCT00105443|E4|Reported Event|Placebo Arm, Complete Double-Blind Phase|"Reporting Group 4 (RG 4): All participants that initially were randomized to Placebo (data from Placebo patients before unblinding at Feb 09, 2007); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
561113|NCT00105443|E3|Reported Event|Sorafenib (Nexavar) Arm Complete (Incl. Open Label Phase)|Reporting Group 3 (RG 3): All participants that initially were randomized to Sorafenib treatment (data before unblinding (= Double-Blind phase) and after unblinding (= Open Label phase)), until Nov 21, 2008); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
561114|NCT00105443|E2|Reported Event|Placebo Arm Double-Blind Phase (Interim Data Only)|"Reporting Group 2 (RG 2): All participants in Double-Blind phase randomized to Sorafenib-matching placebo (data before Oct 17, 2006); Sorafenib-matching placebo tablets were orally administered twice daily (bid).~Note: Safety Data presented here include participants listed in Arms B1 and B2 of the Participant Flow section."
561115|NCT00105443|E1|Reported Event|Sorafenib (Nexavar) Arm Double-Blind Phase (Interim Data Only)|Reporting Group 1 (RG 1): All participants in Double-Blind phase randomized to Sorafenib treatment (data before Oct 17, 2006); Sorafenib 400 mg was administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid); 2 dose reductions to predefined levels of 400 mg once daily (OD) and 400 mg every other day were permitted for adverse events related to study treatment. Note: Safety Data presented here include participants listed in Arms A1 and A2 of the Participant Flow section.
561116|NCT00105235|B1|Baseline|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561117|NCT00105235|P1|Participant Flow|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561118|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561119|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561129|NCT00105196|B1|Baseline|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561130|NCT00105196|P2|Participant Flow|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561120|NCT00105235|O4|Outcome|Discontinued Immunosuppression Withdrawal|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561121|NCT00105235|O3|Outcome|Completed Withdrawal and Restarted Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561122|NCT00105235|O2|Outcome|Completed Withdrawal and Remains Off Immunosuppression|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561123|NCT00105235|O1|Outcome|Withdrawal Never Started|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561124|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561125|NCT00105235|O1|Outcome|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561126|NCT00105235|E1|Reported Event|Alemtuzumab|Recipients of a liver allograft for end-stage liver disease received a 30 mg IV dose of alemtuzumab on study days 0 and 4 (immunosuppressive induction). Beginning on study day 1, participants received tacrolimus orally (dose adjusted to yield trough blood levels of 5-12 ng/mL) with or without mycophenolate orally (<= 1.5g twice daily), at the discretion of the investigator. Six months post transplant, the tacrolimus dose was adjusted to yield trough blood levels of 5-10 ng/mL. Participants with significant toxicities related to tacrolimus were changed to cyclosporine (CsA), with the dose adjusted to maintain trough blood levels of 200-350 ng/mL during the first 3 months post transplant and 100-300 ng/mL from month 4 until CsA tapering was initiated. Maintenance immunosuppression was maintained for at least 12 months. At 12 months, participants were assessed for immune reconstitution and for the ability to undergo tapering and subsequent withdrawal of immunosuppression
561127|NCT00105196|B3|Baseline|Total|Total of all reporting groups
561128|NCT00105196|B2|Baseline|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561169|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561131|NCT00105196|P1|Participant Flow|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561132|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561133|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561134|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561135|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561136|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561137|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561138|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561139|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561140|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561141|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561142|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561143|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561144|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561145|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561146|NCT00105196|O2|Outcome|Placebo + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (placebo). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561147|NCT00105196|O1|Outcome|Aripiprazole + ADT|Subjects with a recorded baseline value at Week 8 and at least one recorded value on randomized study drug (aripiprazole). Missing baseline values were not imputed. Missing values on study drug were imputed using LOCF. Baseline values were not carried forward.
561148|NCT00105196|E2|Reported Event|Placebo|
561149|NCT00105196|E1|Reported Event|Aripiprazole|
561150|NCT00105183|B4|Baseline|Total|Total of all reporting groups
561151|NCT00105183|B3|Baseline|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561152|NCT00105183|B2|Baseline|Placebo|USP 0.9% sodium chloride solution
561153|NCT00105183|B1|Baseline|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561154|NCT00105183|P3|Participant Flow|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561155|NCT00105183|P2|Participant Flow|Placebo|USP 0.9% sodium chloride solution
561156|NCT00105183|P1|Participant Flow|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561157|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561158|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
561159|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561160|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561161|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
561162|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561163|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561164|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
561165|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561166|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561167|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
561168|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561180|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561181|NCT00105183|O3|Outcome|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561182|NCT00105183|O2|Outcome|Placebo|USP 0.9% sodium chloride solution
561183|NCT00105183|O1|Outcome|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561184|NCT00105183|E3|Reported Event|EZ-2053 5mg/kg|Anti-human-T-Lymphocyte Immune Globulin, Rabbit
561185|NCT00105183|E2|Reported Event|Placebo|USP 0.9% sodium chloride solution
561186|NCT00105183|E1|Reported Event|EZ-2053 9mg/kg|Anti-human-T-lymphocyte Immune Globulin, Rabbit (EZ-2053)
561187|NCT00105157|B5|Baseline|Total|Total of all reporting groups
561188|NCT00105157|B4|Baseline|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561189|NCT00105157|B3|Baseline|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561190|NCT00105157|B2|Baseline|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561191|NCT00105157|B1|Baseline|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561192|NCT00105157|P4|Participant Flow|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561193|NCT00105157|P3|Participant Flow|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561194|NCT00105157|P2|Participant Flow|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561195|NCT00105157|P1|Participant Flow|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561196|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561197|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561198|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561199|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561200|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561201|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561202|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561203|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561204|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561205|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561206|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561207|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561254|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561208|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561209|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561210|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561211|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561212|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561213|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561214|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561215|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561216|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561217|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561218|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561219|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561220|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561221|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561222|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561223|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561224|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561225|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561226|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561227|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561228|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561229|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561230|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561278|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
562139|NCT00101686|P6|Participant Flow|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
561231|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561232|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561233|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561234|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561235|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561236|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561237|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561238|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561239|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561240|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561241|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561242|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561243|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561244|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561245|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561246|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561247|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561248|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561249|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561250|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561251|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561252|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561253|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
562140|NCT00101686|P5|Participant Flow|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
561255|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561256|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561257|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561258|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561259|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561260|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561261|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561262|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561263|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561264|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561265|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561266|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561267|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561268|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561269|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561270|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561271|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561272|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561273|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561274|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561275|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561276|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561277|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
562141|NCT00101686|P4|Participant Flow|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
561279|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561280|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561281|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561282|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561283|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561284|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561285|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561286|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561287|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561288|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561289|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561290|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561291|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561292|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561293|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561294|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561295|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561296|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561297|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561298|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561299|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561300|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561301|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
562142|NCT00101686|P3|Participant Flow|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
561302|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561303|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561304|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561305|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561306|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561307|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561308|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561309|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561310|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561311|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561312|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561313|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561314|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561315|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561316|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561317|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561318|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561319|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561320|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561321|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561322|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561323|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561324|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561399|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561325|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561326|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561327|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561328|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561329|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561330|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561331|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561332|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561333|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561334|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561335|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561336|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561337|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561338|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561339|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561340|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561341|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561342|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561343|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561344|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561345|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561346|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561347|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561400|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561348|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561349|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561350|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561351|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561352|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561353|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561354|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561355|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561356|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561357|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561358|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561359|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561360|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561361|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561362|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561363|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561364|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561365|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561366|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561367|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561368|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561369|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561370|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561401|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
562143|NCT00101686|P2|Participant Flow|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
561371|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561372|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561373|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561374|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561375|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561376|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561377|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561378|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561379|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561380|NCT00105157|O4|Outcome|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561381|NCT00105157|O3|Outcome|MK0518 600 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 600 mg b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561382|NCT00105157|O2|Outcome|MK0518 400 mg b.i.d.|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 400 mg b.i.d.
561383|NCT00105157|O1|Outcome|MK0518 200 mg b.i.d.|Optimized background antiretroviral therapy (OBT), if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 200 mg twice a day (b.i.d.). Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561384|NCT00105157|E2|Reported Event|Placebo|OBT, if possible, based on screening genotypic/phenotypic resistance and past treatment history and MK0518 matching placebo b.i.d.. Once the Phase III dose was determined, all patients were switched to the Phase III dose (400 mg b.i.d.) after completion of at least 24 weeks double-blind therapy.
561385|NCT00105157|E1|Reported Event|MK0518|Includes patients from the MK0518 200 mg, 400 mg, and 600 mg b.i.d. dose groups. Patients who completed at least 24 weeks of double-blind therapy without virologic failure entered the open-label phase to receive open-label MK0518 400 mg b.i.d.
561386|NCT00105079|B3|Baseline|Total|Total of all reporting groups
561387|NCT00105079|B2|Baseline|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561388|NCT00105079|B1|Baseline|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561389|NCT00105079|P2|Participant Flow|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561390|NCT00105079|P1|Participant Flow|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561391|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561392|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561393|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561394|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561395|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561396|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561397|NCT00105079|O2|Outcome|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561398|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
562150|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
561402|NCT00105079|O1|Outcome|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561403|NCT00105079|E2|Reported Event|Lopinavir/Ritonavir|lopinavir/ritonavir 400/100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561404|NCT00105079|E1|Reported Event|Saquinavir/Ritonavir|saquinavir mesylate 1000 mg twice daily (BID) + ritonavir 100 mg BID + emtricitabine/tenofovir disoproxil fumarate 200/300 mg orally every day for 48 weeks.
561405|NCT00105066|B3|Baseline|Total|Total of all reporting groups
561406|NCT00105066|B2|Baseline|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561407|NCT00105066|B1|Baseline|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561408|NCT00105066|P2|Participant Flow|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561409|NCT00105066|P1|Participant Flow|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561410|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561411|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561412|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561413|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561414|NCT00105066|O2|Outcome|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561415|NCT00105066|O1|Outcome|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561416|NCT00105066|E2|Reported Event|Metformin|Metformin : 850mg tablet once a day for one month, then twice a day for 3 months
561417|NCT00105066|E1|Reported Event|Placebo|Placebo : placebo tablet once a day for one month, then twice a day for 3 months
561418|NCT00105027|B7|Baseline|Total|Total of all reporting groups
561419|NCT00105027|B6|Baseline|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561420|NCT00105027|B5|Baseline|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561421|NCT00105027|B4|Baseline|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
561422|NCT00105027|B3|Baseline|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561423|NCT00105027|B2|Baseline|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561424|NCT00105027|B1|Baseline|CRVO Observation|Standard care consists of observation of the macular edema.
561425|NCT00105027|P6|Participant Flow|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561426|NCT00105027|P5|Participant Flow|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561427|NCT00105027|P4|Participant Flow|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
561428|NCT00105027|P3|Participant Flow|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561429|NCT00105027|P2|Participant Flow|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561430|NCT00105027|P1|Participant Flow|CRVO Observation|Standard care consists of observation of the macular edema.
562234|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
561431|NCT00105027|O6|Outcome|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561432|NCT00105027|O5|Outcome|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561433|NCT00105027|O4|Outcome|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
561434|NCT00105027|O3|Outcome|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561435|NCT00105027|O2|Outcome|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561436|NCT00105027|O1|Outcome|CRVO Observation|Standard care consists of observation of the macular edema.
561437|NCT00105027|E6|Reported Event|BRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561438|NCT00105027|E5|Reported Event|BRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561439|NCT00105027|E4|Reported Event|BRVO Standard Care|Standard care was observation followed by grid laser photocoagulation if and when clearing of the hemorrhage permits grid laser photocoagulation. For study eyes of BRVO participants without a dense macular hemorrhage at enrollment, standard care consisted of immediate grid laser photocoagulation. The determination of a dense hemorrhage in the center of the macula (and thus the timing of the grid laser photocoagulation) was left to the discretion of the investigator. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the randomization assigned treatment. Only those eyes eligible for laser photocoagulation (i.e. eyes with BRVO and without a dense macular hemorrhage) were eligible for retreatment.
561440|NCT00105027|E3|Reported Event|CRVO 4 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 4 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561441|NCT00105027|E2|Reported Event|CRVO 1 mg Dose Triamcinolone Acetonide|Treatment administered at baseline. At each 4-month visit during follow-up, the investigator assessed whether persistent or recurrent macular edema was present that warranted retreatment with the 1 mg dose. Patients and investigators were masked to the triamcinolone acetonide dose used (1 mg or 4 mg).
561442|NCT00105027|E1|Reported Event|CRVO Observation|Standard care consists of observation of the macular edema.
561443|NCT00105001|B4|Baseline|Total|Total of all reporting groups
561444|NCT00105001|B3|Baseline|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561445|NCT00105001|B2|Baseline|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561446|NCT00105001|B1|Baseline|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561447|NCT00105001|P3|Participant Flow|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and Mycophenolate Mofetil [MMF] as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561448|NCT00105001|P2|Participant Flow|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561449|NCT00105001|P1|Participant Flow|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive Mycophenolate Mofetil [MMF] PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561450|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561451|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561452|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561453|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561454|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561455|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561456|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561457|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561458|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561475|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
561459|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561460|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561461|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561462|NCT00105001|O3|Outcome|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561463|NCT00105001|O2|Outcome|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561464|NCT00105001|O1|Outcome|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561465|NCT00105001|E3|Reported Event|Arm III (MMF, Tacrolimus, and Sirolimus)|"Patients receive tacrolimus and MMF as in arm II. Patients also receive sirolimus PO once daily on days -3 to 80.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO~Sirolimus: Given PO"
561466|NCT00105001|E2|Reported Event|Arm II (MMF and Tacrolimus Alternate Schedule)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 150 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-180 with taper beginning on day 150 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561467|NCT00105001|E1|Reported Event|Arm I (MMF and Tacrolimus)|"Patients receive tacrolimus IV or PO every 12 hours on days -3 to 180 with taper beginning on day 100 in the absence of GVHD. Patients also receive MMF PO every 8 hours on days 0-29 and then every 12 hours on days 30-96 with taper beginning on day 40 in the absence of GVHD.~Fludarabine Phosphate: Given IV~Total-Body Irradiation: Undergo total-body irradiation~Peripheral Blood Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Allogeneic Hematopoietic Stem Cell Transplantation: Undergo allogeneic peripheral blood stem cell transplantation~Tacrolimus: Given IV or PO~Mycophenolate Mofetil: Given PO"
561468|NCT00104884|B1|Baseline|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
561469|NCT00104884|P1|Participant Flow|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
561470|NCT00104884|O1|Outcome|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
561471|NCT00104884|E1|Reported Event|Depsipeptide|Depsipeptide is administered as a 4-hour IV infusion weekly in doses of 13 mg/m^2 for 3 weeks. Repeat cycle every 28 days until unacceptable toxicity or disease progression.
561472|NCT00104871|B1|Baseline|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
561473|NCT00104871|P1|Participant Flow|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
561474|NCT00104871|O1|Outcome|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
561582|NCT00104416|B1|Baseline|Double-Blind Phase: Placebo|Control - matching placebo once daily
561476|NCT00104871|E1|Reported Event|Bortezomib|Bortezomib 1.3 mg/m^2 intravenous (IV) at over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 4 courses.
561477|NCT00104728|B1|Baseline|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
561478|NCT00104728|P1|Participant Flow|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
561479|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
561480|NCT00104728|O1|Outcome|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
561481|NCT00104728|E1|Reported Event|Neoadjuvant ZD1839 Preoperative Therapy|"The ZD1839 250-mg tablet will be taken once a day, every day about the same time. It can be taken with or without food.~At the time of surgery, investigators will collect tissue from the participant's tumor once it has been removed. This tissue will be used to study the effect of ZD1839 on tumor growth.~ZD1839 :"
561482|NCT00104650|B4|Baseline|Total|Total of all reporting groups
561483|NCT00104650|B3|Baseline|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561484|NCT00104650|B2|Baseline|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561485|NCT00104650|B1|Baseline|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561486|NCT00104650|P3|Participant Flow|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561487|NCT00104650|P2|Participant Flow|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561488|NCT00104650|P1|Participant Flow|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561489|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561490|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561491|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561492|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561493|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561494|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561495|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561496|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561497|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561498|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561499|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561500|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561501|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561502|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561503|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561504|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561505|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561506|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561507|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561508|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561509|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561510|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561511|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561512|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561513|NCT00104650|O3|Outcome|Denosumab 180 mg Q4W|Open-label denosumab 180 mg by subcutaneous injection once every 4 weeks (Q4W)
561514|NCT00104650|O2|Outcome|Denosumab 180 mg Q12W|Open-label denosumab 180 mg by subcutaneous injection once every 12 weeks (Q12W)
561515|NCT00104650|O1|Outcome|Bisphosphonate IV Q4W|Open-label intravenous (IV) bisphosphonate once every 4 weeks (Q4W)
561516|NCT00104650|E3|Reported Event|Denosumab 180 mg Q4W|
561517|NCT00104650|E2|Reported Event|Denosumab 180 mg Q12W|
561518|NCT00104650|E1|Reported Event|Bisphosphonate IV Q4W|
561519|NCT00104637|B1|Baseline|Randomized Participants|All enrolled and randomized participants who were administered 25 mg Sildenafil and 25mg placebo at 2 different time periods.
561520|NCT00104637|P2|Participant Flow|Placebo /Sildenafil|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
561521|NCT00104637|P1|Participant Flow|Sildenafil /Placebo|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
561522|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561523|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561524|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561525|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561526|NCT00104637|O2|Outcome|Placebo|Participants that received Placebo
561527|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561528|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561529|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561530|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561531|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561532|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561533|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561534|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561535|NCT00104637|O1|Outcome|Sildenafil|Group that received Sildenafil
561536|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561537|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
561538|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561539|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
561540|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561541|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day.
561542|NCT00104637|O2|Outcome|Placebo|Placebo by mouth three times a day.
561543|NCT00104637|O1|Outcome|Sildenafil|Sildenafil citrate 25 mg by mouth three times a day
561544|NCT00104637|E2|Reported Event|Placebo|25 mg placebo is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg sildenafil by mouth 3 times daily for 14 days.
561545|NCT00104637|E1|Reported Event|Sildenafil|25 mg sildenafil is taken by mouth 3 times a day for 14 days followed by one week washout and then 25 mg placebo by mouth 3 times daily for 14 days.
561546|NCT00104572|B4|Baseline|Total|Total of all reporting groups
561547|NCT00104572|B3|Baseline|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561548|NCT00104572|B2|Baseline|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561549|NCT00104572|B1|Baseline|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561550|NCT00104572|P3|Participant Flow|Placebo|"9 participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561551|NCT00104572|P2|Participant Flow|Aromatase Inhibitor|"13 participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561552|NCT00104572|P1|Participant Flow|Transdermal Testosterone|"13 participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561553|NCT00104572|O3|Outcome|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561554|NCT00104572|O2|Outcome|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561555|NCT00104572|O1|Outcome|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561556|NCT00104572|E3|Reported Event|Placebo|"participants will receive a placebo tablet and placebo gel daily for 12 months~Placebo tablet: Daily for 12 months~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561557|NCT00104572|E2|Reported Event|Aromatase Inhibitor|"participants will receive anastrozole 1 mg tablet plus placebo gel daily for 12 months~Anastrozole (Aromatase Inhibitor)~Placebo gel: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561558|NCT00104572|E1|Reported Event|Transdermal Testosterone|"participants will receive testosterone gel (5 gm) plus placebo tablet daily for 12 months~Androgel (Testosterone Gel): 1 mg tablet for 12 months~Placebo tablet: Daily for 12 months~Calcium Cardone 500mg with vitamin D 400 IU: 1 tablet three times a day"
561559|NCT00104520|B3|Baseline|Total|Total of all reporting groups
561560|NCT00104520|B2|Baseline|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561634|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561561|NCT00104520|B1|Baseline|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561562|NCT00104520|P2|Participant Flow|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561563|NCT00104520|P1|Participant Flow|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561564|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561565|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561566|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561567|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561568|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561569|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561570|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561571|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561572|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561573|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561574|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561575|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561576|NCT00104520|O2|Outcome|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561577|NCT00104520|O1|Outcome|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561578|NCT00104520|E2|Reported Event|AZLI (Pooled BID/TID)|AZLI (75 mg/mL aztreonam lysine when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.0, and osmolality 300 to 550 mOsmol/kg). AZLI was self-administered by inhalation BID or TID using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561579|NCT00104520|E1|Reported Event|Placebo (Pooled BID/TID)|Placebo (5 mg/mL lactose when reconstituted in diluent [0.17% saline]; sterile, pH 4.2 to 7.5, and osmolality 200 to 400 mOsmol/kg). Placebo was self-administered twice daily (BID) or three times daily (TID) by inhalation using the investigational nebulizer. All analyses were conducted on the pooled placebo vs pooled AZLI treatment groups.
561580|NCT00104416|B3|Baseline|Total|Total of all reporting groups
561581|NCT00104416|B2|Baseline|Double-Blind Phase: LTG XR|LTG XR once daily
561583|NCT00104416|P5|Participant Flow|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
561584|NCT00104416|P4|Participant Flow|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
561585|NCT00104416|P3|Participant Flow|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
561586|NCT00104416|P2|Participant Flow|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
561587|NCT00104416|P1|Participant Flow|Double-Blind Phase: Placebo|Control - matching placebo once daily
561588|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561589|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561590|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561591|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561592|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561593|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561594|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561595|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561596|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561597|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561598|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561599|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561600|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561601|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561602|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561603|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561604|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
561605|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
561606|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
561607|NCT00104416|O3|Outcome|Baseline Failures|Baseline failures who entered the CP
561608|NCT00104416|O2|Outcome|Continuation Phase: LTG/LTG|LTG XR participants who entered the CP
561609|NCT00104416|O1|Outcome|Continuation Phase: Placebo/LTG|Placebo participants who entered the CP
561610|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561611|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561612|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561613|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561614|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561615|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561616|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561617|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561618|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561619|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561620|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561621|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561622|NCT00104416|O2|Outcome|Double-Blind Phase: LTG XR|LTG XR once daily
561623|NCT00104416|O1|Outcome|Double-Blind Phase: Placebo|Control - matching placebo once daily
561624|NCT00104416|E5|Reported Event|Baseline Failures|Baseline failures who entered the CP without receiving treatment in the Double-Blind Phase. Baseline Failures were participants that successfully progressed through the Screening Phase and completed the Baseline Phase of the Double-blind Study, but ultimately did not meet the seizure frequency criteria for randomization into the Double-Blind Treatment Phase of the study. As a result, they were not counted as having started in the Double-Blind Study, but were eligible to enter the CP of the study.
561625|NCT00104416|E4|Reported Event|Continuation Phase: LTG/LTG|Participants who received LTG XR in the Double-Blind Phase and then entered the CP, in which they received LTG
561626|NCT00104416|E3|Reported Event|Continuation Phase: Placebo/LTG|Participants who received placebo in the Double-Blind Phase and then entered the CP, in which they received LTG
561627|NCT00104416|E2|Reported Event|Double-Blind Phase: LTG XR|Lamotrigine (LTG) extended release (XR) once daily
561628|NCT00104416|E1|Reported Event|Double-Blind Phase: Placebo|Control - matching placebo once daily
561629|NCT00104299|B3|Baseline|Total|Total of all reporting groups
561630|NCT00104299|B2|Baseline|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561631|NCT00104299|B1|Baseline|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561632|NCT00104299|P2|Participant Flow|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561633|NCT00104299|P1|Participant Flow|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561635|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561636|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561637|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561638|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561639|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561640|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561641|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561642|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561643|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561644|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561645|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561646|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561647|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561648|NCT00104299|O2|Outcome|Control Group|Participants received placebo−rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled “Detailed Description” for additional treatment information.
561649|NCT00104299|O1|Outcome|Rituximab|Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo−cyclophosphamide. Refer to section titled “Detailed Description” for additional treatment information.
561650|NCT00104299|E2|Reported Event|Control Group|"Participants received placebo-rituximab infusions plus daily cyclophosphamide (2 mg per kilogram of body weight, adjusted for renal insufficiency). Refer to section titled Detailed Description for additional treatment information."
561651|NCT00104299|E1|Reported Event|Rituximab|"Participants received intravenous rituximab (Rituxan, Genentech) (at a dose of 375 mg per square meter of body-surface area once weekly for 4 weeks) plus daily placebo-cyclophosphamide. Refer to section titled Detailed Description for additional treatment information."
561652|NCT00104247|B3|Baseline|Total|Total of all reporting groups
561653|NCT00104247|B2|Baseline|Placebo|Placebo
561654|NCT00104247|B1|Baseline|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
561655|NCT00104247|P2|Participant Flow|Placebo|Placebo
561656|NCT00104247|P1|Participant Flow|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
561657|NCT00104247|O2|Outcome|Placebo|Placebo
561658|NCT00104247|O1|Outcome|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
561659|NCT00104247|E2|Reported Event|Placebo|Placebo
561660|NCT00104247|E1|Reported Event|Sapropterin Dihydrochloride|Patients administered 10 mg /kg orally once daily.
561661|NCT00104234|B3|Baseline|Total|Total of all reporting groups
561662|NCT00104234|B2|Baseline|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
561663|NCT00104234|B1|Baseline|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
561664|NCT00104234|P2|Participant Flow|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
561665|NCT00104234|P1|Participant Flow|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
561666|NCT00104234|O1|Outcome|All Participants (N=37)|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
561667|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
562004|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
561668|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
561669|NCT00104234|O2|Outcome|Placebo/rhASB|Patients received placebo in the double-blind study (ASB-03-05, NCT00067470)then received rhASB in the extension study (ASB-03-06).
561670|NCT00104234|O1|Outcome|rhASB/rhASB|Patients received rhASB in the double-blind study(ASB-03-05, NCT00067470)and continued to receive rhASB in the extension study(ASB-03-06).
561671|NCT00104234|E1|Reported Event|All Participants|rhASB/rhASB and placebo/rhASB groups were combined for analysis.
561672|NCT00104104|B3|Baseline|Total|Total of all reporting groups
561673|NCT00104104|B2|Baseline|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561674|NCT00104104|B1|Baseline|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561675|NCT00104104|P2|Participant Flow|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561676|NCT00104104|P1|Participant Flow|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561677|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561678|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561679|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561680|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561681|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561682|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561683|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561684|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561685|NCT00104104|O2|Outcome|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561686|NCT00104104|O1|Outcome|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3–4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561687|NCT00104104|E2|Reported Event|30 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 30-minute infusion time, but increasing to a 45-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12-weeks.
561688|NCT00104104|E1|Reported Event|15 - Minute Infusion|Participants received 4 mg zoledronic acid intravenously, in 250 mL of fluid, every 3-4 weeks for up to 24 months, over a 15-minute infusion time, but increasing to a 30-minute infusion time if they experienced a clinically relevant rise in serum creatinine that resolved in less than 12 weeks.
561689|NCT00104052|B1|Baseline|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
561690|NCT00104052|P1|Participant Flow|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
562046|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
561691|NCT00104052|O1|Outcome|PEG-Intron Plus REBETOL|SCH 54031 PEG-Intron (peginterferon alfa-2b) 60 µg/m2 subcutaneous injection once weekly plus SCH 18908 REBETOL (ribavirin) 15 mg/kg PO daily in two divided doses for 48 weeks for subjects with Genotypes 1,4,5,6 and high-viral-load (≥600,000 IU/mL) Genotype 3 subjects. For subjects with Genotype 2 or low-viral-load Genotype 3 (<600,000 IU/mL), the same treatment will be given for 24 weeks.
561692|NCT00104052|E1|Reported Event|PEG-Intron Plus REBETOL|
561693|NCT00103857|B8|Baseline|Total|Total of all reporting groups
561694|NCT00103857|B7|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
561695|NCT00103857|B6|Baseline|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561696|NCT00103857|B5|Baseline|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561697|NCT00103857|B4|Baseline|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561698|NCT00103857|B3|Baseline|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561699|NCT00103857|B2|Baseline|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561700|NCT00103857|B1|Baseline|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561701|NCT00103857|P7|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
561806|NCT00103740|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561999|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
561702|NCT00103857|P6|Participant Flow|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561703|NCT00103857|P5|Participant Flow|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561704|NCT00103857|P4|Participant Flow|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561705|NCT00103857|P3|Participant Flow|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561706|NCT00103857|P2|Participant Flow|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561707|NCT00103857|P1|Participant Flow|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561708|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561709|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561710|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561807|NCT00103740|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561711|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561712|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561713|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561714|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561715|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561716|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561717|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561718|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561719|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561808|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
562000|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
561720|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561721|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561722|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561723|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561724|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561725|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561726|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561727|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561728|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561809|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
562001|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
561729|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561730|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561731|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561732|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561733|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561734|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561735|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561736|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561737|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561810|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
562002|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
561738|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561739|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561740|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561741|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561742|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561743|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561744|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561745|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561746|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561811|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
562151|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
561747|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561748|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561749|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561750|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561751|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561752|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561753|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561754|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561755|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561812|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
562003|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
561756|NCT00103857|O6|Outcome|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily.) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561757|NCT00103857|O5|Outcome|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561758|NCT00103857|O4|Outcome|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily)and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561759|NCT00103857|O3|Outcome|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561760|NCT00103857|O2|Outcome|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily.) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561761|NCT00103857|O1|Outcome|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561762|NCT00103857|E7|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. OLC|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) OLC (Open-label Cohort) includes data from non-randomized patients assigned to receive treatment with open-label, oral tablets of sitagliptin and metformin. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning on Day 1. The dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients continued to take open-label sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the Phase A treatment period of up to 24 weeks. Results presented for the OLC are through Week 24. Patients in the OLC completed the study at Week 24.
561763|NCT00103857|E6|Reported Event|Placebo/Metformin 1000 mg b.i.d.|The Placebo/Metformin 1000 mg b.i.d. group (b.i.d. = twice daily) includes data from patients randomized to receive the sequence of treatment with oral tablets of placebo (randomization/Day 1 through Week 24) followed by metformin. Beginning at Week 24, patients were switched in a blinded manner to active treatment with metformin administered as 500 mg q.d. (q.d. = once daily) increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the up to 30-week Phase B base study treatment period and during the extension study of up to 50 weeks.
561764|NCT00103857|E5|Reported Event|Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d.|The Sitagliptin 50 mg b.i.d + Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 1000 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; the dose of sitagliptin was increased after 1-week to 50 mg b.i.d and the dose of metformin was increased over 4 weeks by increments of 500 mg per week to 1000 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561813|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561765|NCT00103857|E4|Reported Event|Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d.|The Sitagliptin 50 mg b.i.d. + Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 50 mg b.i.d + metformin 500 mg b.i.d. Treatment was co-administered as sitagliptin 50 mg q.d. (q.d. = once daily) and metformin 500 mg q.d. beginning at randomization/Day 1; after 1-week, the dose of sitagliptin was increased to 50 mg b.i.d. and the dose of metformin was increased to 500 mg b.i.d. Patients in this group continued to take sitagliptin 50 mg b.i.d. and metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561766|NCT00103857|E3|Reported Event|Metformin 1000 mg b.i.d.|The Metformin 1000 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 1000 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased over 4 weeks by increments of 500 mg per week to a stable dose of 1000 mg b.i.d. Patients in this group continued to take metformin 1000 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561767|NCT00103857|E2|Reported Event|Metformin 500 mg b.i.d.|The Metformin 500 mg b.i.d. (b.i.d. = twice daily) group includes data from patients randomized to receive treatment with oral tablets of metformin 500 mg b.i.d. Treatment was administered as 500 mg q.d. (q.d. = once daily) beginning at randomization/Day 1 and increased after 1 week to a stable dose of 500 mg b.i.d. Patients in this group continued to take metformin 500 mg b.i.d for the remainder of the treatment period of up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study).
561768|NCT00103857|E1|Reported Event|Sitagliptin 100 mg q.d.|The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with two 50 mg oral tablets of sitagliptin once daily for up to 104 weeks (including the 54-week base study [24-week, placebo-controlled Phase A and 30-week, active-controlled Phase B] and 50-week extension study). Note: In this double-blind, double-dummy study, randomized patients in the base study received a total of 7 tablets (active or placebo) per day administered in the specified tablet images as follows: sitagliptin 50 mg 2 tablets in the morning and 1 tablet in the evening, metformin 500 mg 2 tablets b.i.d. (b.i.d. = twice daily). In the extension study, patients received a total of 7 tablets (active or placebo) per day. Tablets in the image of sitagliptin (active or placebo) were administered as sitagliptin 100 mg 1 tablet in the morning and sitagliptin 50 mg 1 tablet b.i.d. Metformin administration occurred in the same manner as specified in the base study.
561769|NCT00103844|B3|Baseline|Total|Total of all reporting groups
561770|NCT00103844|B2|Baseline|Imatinib|Imatinib 400 mg BID
561771|NCT00103844|B1|Baseline|Dasatinib|Dasatinib 70 mg twice a day (BID)
561772|NCT00103844|P2|Participant Flow|Imatinib First|Imatinib 400 mg BID in the first intervention period and, if intolerance to imatinib or progression or lack of efficacy, dasatinib 70 mg BID in the second intervention period (after washout period).
561773|NCT00103844|P1|Participant Flow|Dasatinib First|Dasatinib 70 mg twice a day (BID) in the first intervention period and, if intolerance to dasatinib or progression, imatinib 400 mg BID in the second intervention period (after washout period).
561774|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561775|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561776|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561777|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561778|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561779|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561780|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561781|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561782|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561783|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561784|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561785|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561786|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561787|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561788|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561789|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561790|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561791|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561792|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561793|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561794|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561795|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561796|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561797|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561798|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561799|NCT00103844|O2|Outcome|Imatinib|Imatinib 400 mg BID
561800|NCT00103844|O1|Outcome|Dasatinib|Dasatinib 70 mg twice a day (BID)
561801|NCT00103844|E2|Reported Event|IMATINIB|Imatinib 400 mg BID
561802|NCT00103844|E1|Reported Event|DASATINIB|Dasatinib 70 mg twice a day (BID)
561803|NCT00103740|B3|Baseline|Total|Total of all reporting groups
561804|NCT00103740|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561805|NCT00103740|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561896|NCT00103506|E1|Reported Event|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561897|NCT00103311|B3|Baseline|Total|Total of all reporting groups
561814|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561815|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561816|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561817|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561818|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561819|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561820|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561821|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561822|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561823|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561824|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561825|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561826|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561827|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561828|NCT00103740|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561829|NCT00103740|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561830|NCT00103740|E2|Reported Event|Risedronate|Participants received 60 days of oral risedronate 30 mg, one i.v. infusion of placebo to zoledronic acid infusion, calcium 500mg bid and vitamin d 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561831|NCT00103740|E1|Reported Event|Zoledronic Acid|Participants received zoledronic acid 5.0 mg i.v. infusion one dose, 60 days of oral placebo to risedronate, calcium 500mg bid and vitamin D 400 to 1000 IU daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
561832|NCT00103662|B3|Baseline|Total|Total of all reporting groups
561833|NCT00103662|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561834|NCT00103662|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561993|NCT00102687|P3|Participant Flow|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
561835|NCT00103662|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561836|NCT00103662|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561837|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561838|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561839|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561840|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561841|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561842|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561843|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561844|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561845|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561846|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561847|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561848|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561849|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561850|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561851|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561852|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561853|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561994|NCT00102687|P2|Participant Flow|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
561854|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561855|NCT00103662|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561856|NCT00103662|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561857|NCT00103662|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561858|NCT00103662|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 6*10^6 CD34+ cells/kg were collected.
561859|NCT00103610|B3|Baseline|Total|Total of all reporting groups
561860|NCT00103610|B2|Baseline|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561861|NCT00103610|B1|Baseline|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561862|NCT00103610|P2|Participant Flow|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561863|NCT00103610|P1|Participant Flow|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561864|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561865|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561866|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561867|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561868|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561869|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561870|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561871|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561872|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561873|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
562152|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
561874|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561875|NCT00103610|O1|Outcome|G-CSF + Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561876|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561877|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561878|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561879|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561880|NCT00103610|O2|Outcome|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561881|NCT00103610|O1|Outcome|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561882|NCT00103610|E2|Reported Event|G-CSF Plus Placebo|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of placebo. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of placebo for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561883|NCT00103610|E1|Reported Event|G-CSF Plus Plerixafor|Participants underwent mobilization with G-CSF for 4 days. On the evening of Day 4, participants received a dose of plerixafor. On each subsequent day, participants received a morning dose of G-CSF followed by apheresis and an evening dose of plerixafor for a maximum of 4 aphereses or until ≥ 5*10^6 CD34+ cells/kg were collected.
561884|NCT00103506|B3|Baseline|Total|Total of all reporting groups
561885|NCT00103506|B2|Baseline|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561886|NCT00103506|B1|Baseline|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561887|NCT00103506|P2|Participant Flow|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561888|NCT00103506|P1|Participant Flow|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561889|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561890|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561891|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561892|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561893|NCT00103506|O2|Outcome|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561894|NCT00103506|O1|Outcome|Velcade (Bortezomib) Monotherapy|Velcade (bortezomib) 1.3 milligram/meter per square (mg/m^2) by rapid (bolus) intravenous (IV) administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles.
561895|NCT00103506|E2|Reported Event|Doxil/Caelyx Plus Velcade (Bortezomib)|Velcade (bortezomib) 1.3 mg/m^2 by rapid (bolus) IV administration given on Day 1, 4, 8, and 11 of each 21-day cycle for up to 8 cycles. Doxorubicin hydrochloride (DOXIL/CAELYX) 30 mg/m^2 by IV infusion will be given on Day 4 of every 21-day cycle after the administration of VELCADE (bortezomib) up to 8 cycles.
561898|NCT00103311|B2|Baseline|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561899|NCT00103311|B1|Baseline|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561900|NCT00103311|P2|Participant Flow|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561901|NCT00103311|P1|Participant Flow|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561902|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561903|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561904|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561905|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561906|NCT00103311|O2|Outcome|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561907|NCT00103311|O1|Outcome|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561908|NCT00103311|E2|Reported Event|Arm II|"Patients receive SB-715992 IV at 18 mg/m2 over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561909|NCT00103311|E1|Reported Event|Arm I|"Patients receive SB-715992 IV at 7 mg/m2 over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~ispinesib: Given IV~laboratory biomarker analysis: Correlative studies"
561910|NCT00103259|B3|Baseline|Total|Total of all reporting groups
561911|NCT00103259|B2|Baseline|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561912|NCT00103259|B1|Baseline|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561913|NCT00103259|P2|Participant Flow|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561914|NCT00103259|P1|Participant Flow|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561915|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561916|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561917|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561918|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561919|NCT00103259|O1|Outcome|Cross-over From Bortezomib to Combined Arm|Patients progressed on bortezomib in step 1 crossed over to the combination arm. Response rate is evaluated in these patients.
561920|NCT00103259|O2|Outcome|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561921|NCT00103259|O1|Outcome|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561922|NCT00103259|E3|Reported Event|Cross-over Patients|11 patients crossed over to bortezomib + irinotecan after progressed on bortezomib single agent. Adverse events were reported for the 11 patients while receiving the combination therapy.
561995|NCT00102687|P1|Participant Flow|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
561923|NCT00103259|E2|Reported Event|Arm II (Bortezomib)|Patients receive bortezomib (PS-341) 1.3 mg/m2 IV over 3-5 seconds twice weekly on days 1, 4, 8 and 11 followed by one week of rest. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Upon disease progression, patients may cross over to arm I (bortezomib + irinotecan).
561924|NCT00103259|E1|Reported Event|Arm I (Bortezomib+Irinotecan)|Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan hydrochloride IV over 90 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
561925|NCT00103207|B1|Baseline|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
561926|NCT00103207|P1|Participant Flow|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
561927|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
561928|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
561929|NCT00103207|O2|Outcome|Former/Current Smoker|Eligible and treated patients who are former or current smokers.
561930|NCT00103207|O1|Outcome|Never Smoker|Eligible and treated patients who never smoked.
561931|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
561932|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
561933|NCT00103207|O1|Outcome|Cetuximab|"Cetuximab was given as a weekly intravenous (IV) infusion (over 60 minutes) at 250 mg/m2 from week 2 onwards after an initial loading dose of 400 mg/m2 (over 120 minutes) on week 1 until disease progression or unacceptable toxicity. The infusion rate of cetuximab could not exceed 5 mL/min. Each cycle will be 28 days in length. To prevent a hypersensitivity reaction, all patients were premedicated with diphenhydramine hydrochloride 50 mg (or an equivalent antihistamine) by IV (over 30-60 minutes) prior to the first dose of cetuximab. Premedication might be administered prior to subsequent doses, but at the investigator's discretion, the dose of diphenhydramine (or a similar agent) was reduced.~Only eligible patients with confirmed diagnosis are included in the main analysis."
561934|NCT00103207|E1|Reported Event|Cetuximab|All treated patients were evaluated for toxicities.
561935|NCT00103194|B1|Baseline|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561936|NCT00103194|P1|Participant Flow|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561937|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561938|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561939|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561996|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
561940|NCT00103194|O1|Outcome|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561941|NCT00103194|E1|Reported Event|GW572016 (Lapatinib)|GW572016 was administered at a dose of 1500 mg orally daily on an outpatient basis. Patients were advised to take GW572016 on an empty stomach (either 1 hour before or 1 hour after meals). GW572016 was administered continuously until disease progression or unacceptable toxicities. For the purposes of protocol evaluations, a cycle was defined as 28 days.
561942|NCT00103142|B3|Baseline|Total|Total of all reporting groups
561943|NCT00103142|B2|Baseline|Experimental PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (Granulocyte-macrophage colony-stimulating factor or GM-CSF) subcutaneous (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
561944|NCT00103142|B1|Baseline|Experimental PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-Carcinoembryonic antigen (CEA)-Mucin 1 (MUC-1)-TRIad of COstimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneous (SC) and intradermally (ID) on days 28, 56, and 84.
561945|NCT00103142|P2|Participant Flow|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
561946|NCT00103142|P1|Participant Flow|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
561947|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
561948|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
561949|NCT00103142|O2|Outcome|PANVAC-V + PANVAC-F + GM-CSF|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) subcutaneously (SC) into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
561950|NCT00103142|O1|Outcome|PANVAC-V + PANVAC-F + DC|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-carcinoembryonic antigen (CEA)- mucin 1 (MUC-1)-TRiad of Costimulatory Molecules (TRICOM) (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine subcutaneously (SC) and intradermally (ID) on days 28, 56, and 84.
561951|NCT00103142|E2|Reported Event|Arm II|Patients receive PANVAC-V SC on day 1 and PANVAC-F SC on days 28, 56, and 84. Patients also receive sargramostim (GM-CSF) SC into the same injection site once daily on days 0-3, 28-31, 56-59, and 84-87.
561952|NCT00103142|E1|Reported Event|Arm I|Patients undergo leukapheresis to obtain leukocytes for generation of autologous dendritic cells (DC). Patients then receive autologous DC loaded with vaccinia-CEA-MUC-1-TRICOM (PANVAC-V) vaccine subcutaneously (SC) and intradermally (ID) on day 1 and autologous DC loaded with fowlpox-CEA-MUC-1-TRICOM (PANVAC-F) vaccine SC and ID on days 28, 56, and 84.
561953|NCT00103012|B4|Baseline|Total|Total of all reporting groups
561954|NCT00103012|B3|Baseline|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
561955|NCT00103012|B2|Baseline|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
561956|NCT00103012|B1|Baseline|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
561957|NCT00103012|P3|Participant Flow|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
561958|NCT00103012|P2|Participant Flow|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
561959|NCT00103012|P1|Participant Flow|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
561960|NCT00103012|O3|Outcome|Influence of Panax Ginseng on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
561961|NCT00103012|O2|Outcome|Influence of Echinacea on Lopinavir Disposition|Lopinavir (administered as lopinavir-ritonavir X 2 weeks)pharmacokinetics determined before, and after 14 days of Echinacea purpurea administration (500 mg three times daily) to healthy human volunteers.
561962|NCT00103012|O1|Outcome|Influence of Ginkgo Biloba on Lopinavir Disposition|Lopinavir pharmacokinetics (administered as lopinavir-ritonavir X 2 weeks) determined before, and after 14 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
561997|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
561963|NCT00103012|E3|Reported Event|Influence of Panax Ginseng on Lopinavir/Ritonavir Disposition|Lopinavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Panax ginseng (500 mg twice daily).
561964|NCT00103012|E2|Reported Event|Influence of Echinacea on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Echinacea(500 mg three times daily).
561965|NCT00103012|E1|Reported Event|Influence of Ginkgo Biloba on Lopinavir/Ritonavir Disposition|Lopinavir + ritonavir (x 2 weeks), midazolam (single dose), and fexofenadine (single dose) pharmacokinetics determined before, and after 14-28 days of Ginkgo Biloba administration (120 mg two times daily) to healthy human volunteers.
561966|NCT00102804|B3|Baseline|Total|Total of all reporting groups
561967|NCT00102804|B2|Baseline|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561968|NCT00102804|B1|Baseline|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561969|NCT00102804|P2|Participant Flow|Placebo and BSC|"Placebo: IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561970|NCT00102804|P1|Participant Flow|Pemetrexed and BSC|"Pemetrexed: 500 milligrams per square meter (mg/m^2), intravenous (IV) administration, every (q) 21 days, until disease progression.~Best Supportive Care (BSC): Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561971|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561972|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561973|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561974|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561975|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561976|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561977|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561978|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561979|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561980|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561981|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561982|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561983|NCT00102804|O2|Outcome|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561984|NCT00102804|O1|Outcome|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561985|NCT00102804|E2|Reported Event|Placebo and BSC|"Placebo: IV administration, q 21 days.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561986|NCT00102804|E1|Reported Event|Pemetrexed and BSC|"Pemetrexed: 500 mg/m^2, IV administration, q 21 days, until disease progression.~BSC: Treatment without a specific antineoplastic regimen, given with the intent to maximize quality of life, as judged by the treating physician."
561987|NCT00102687|B4|Baseline|Total|Total of all reporting groups
561988|NCT00102687|B3|Baseline|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
561989|NCT00102687|B2|Baseline|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
561990|NCT00102687|B1|Baseline|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
561991|NCT00102687|P5|Participant Flow|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
561992|NCT00102687|P4|Participant Flow|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
561998|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
562005|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
562006|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
562007|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
562008|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562009|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562010|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562011|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562012|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562013|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562014|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their treatment assigned during the initial study period through month 7 to month 23.
562015|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
562016|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
562017|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562018|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562019|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562020|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562021|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562022|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562023|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
562024|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23.
562025|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23.
562026|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562027|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562028|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562029|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562030|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562031|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562032|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
562033|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
562034|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
562035|NCT00102687|O3|Outcome|Initial Period Treatment Continued Into Maintenance|Combines participants who continued their original treatment assigned during the initial study period through month 7 to month 23.
562036|NCT00102687|O2|Outcome|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
562037|NCT00102687|O1|Outcome|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
562038|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562039|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562040|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562041|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562042|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562043|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562044|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562045|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562153|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562047|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562048|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562049|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562050|NCT00102687|O3|Outcome|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562051|NCT00102687|O2|Outcome|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562052|NCT00102687|O1|Outcome|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562053|NCT00102687|E5|Reported Event|Maintenance Aza 5 Days q 6 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 6 weeks from month 7 to month 23
562054|NCT00102687|E4|Reported Event|Maintenance Aza 5 Days q 4 Weeks|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days every 4 weeks from month 7 to month 23
562055|NCT00102687|E3|Reported Event|Aza-5-2-5|Azacitidine administered subcutaneously at 50mg/m^2 for 5 days with 2 days off, then for an additional 5 days, on a 28 day cycle.
562056|NCT00102687|E2|Reported Event|Aza-5-2-2|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days with 2 days off, then for an additional 2 days, on a 28 day cycle.
562057|NCT00102687|E1|Reported Event|Aza-5|Azacitidine administered subcutaneously at 75mg/m^2 for 5 days on a 28 day cycle.
562058|NCT00102596|B1|Baseline|All Participants|Baseline is included for all participants who passed screening and received at least 1 dose of 1-octanol, whether in Part A, B or C
562059|NCT00102596|P2|Participant Flow|Part B Then C: Fixed Dose|"In Part B, subjects fasted overnight for 6 hours and received 64 mg/kg 1-octanol at 6AM of both formulations:~1) 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; or 2) a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).~At the completion of Parts A and B, an exploratory Part C was added in which subjects fasted overnight for 6 hours and received 128 mg/kg 1-octanol at 6AM of both formulations."
562060|NCT00102596|P1|Participant Flow|Part A: Dose Escalation|"Subjects fasted overnight for 6 hours and received 1, 4, 8, 16, 32 and 64 mg/kg 1-octanol at 6AM on different days. There were 2 formulations:~1) 2 participants received 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages; and 2) two participants received a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA)."
562061|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
562062|NCT00102596|O1|Outcome|1-Octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of the 1-octanol
562063|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
562064|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
562065|NCT00102596|O2|Outcome|64 mg/kg 1-Octanol Soybean Oil Embedded (SOY) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol in a soft-gel capsule containing 1-octanol embedded in soybean oil at 50 mg and 800 mg dosages (Best Formulations Inc, City of Industry, CA).
562066|NCT00102596|O1|Outcome|64 mg/kg 1-Octanol Cellulose-based (CEL) Formulation|Subjects fasted overnight for 6 hours. At 6AM subjects received 64 mg/kg of the 1-octanol adsorbed to microcrystalline cellulose, NF (Avicel PH 102, FMC Corp., Philadelphia, PA), and fine particle silica (Sipernat 50S, Evonik Degussa Corp., Parsippany, NJ) and encapsulated in 50 mg and 250 mg dosages.
562067|NCT00102596|E1|Reported Event|1-octanol Dose|Subjects fasted overnight for 6 hours. At 6AM subjects received 1-128 mg/kg of 1-octanol
562068|NCT00102518|B1|Baseline|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562069|NCT00102518|P1|Participant Flow|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562070|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562071|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562072|NCT00102518|O1|Outcome|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562073|NCT00102518|E1|Reported Event|NCT00102063 and NCT00110461 Subjects|All subjects had either completed or had withdrawn from the double-blind extension phase of study 31-03-240 and study 31-03-239.
562074|NCT00101816|B3|Baseline|Total|Total of all reporting groups
562087|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562088|NCT00101816|O2|Outcome|Study Day 8|
562089|NCT00101816|O1|Outcome|Study Day 1|
562090|NCT00101816|O2|Outcome|Study Day 8|
562091|NCT00101816|O1|Outcome|Study Day 1|
562092|NCT00101816|O2|Outcome|Study Day 8|
562075|NCT00101816|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562076|NCT00101816|B1|Baseline|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562077|NCT00101816|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562078|NCT00101816|P1|Participant Flow|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562079|NCT00101816|O3|Outcome|Total|
562080|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562081|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562082|NCT00101816|O2|Outcome|Study Day 8|
562083|NCT00101816|O1|Outcome|Study Day 1|
562084|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562085|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562086|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562093|NCT00101816|O1|Outcome|Study Day 1|
562094|NCT00101816|O2|Outcome|Study Day 8|
562095|NCT00101816|O1|Outcome|Study Day 1|
562099|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562100|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562101|NCT00101816|O3|Outcome|Total|
562102|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562103|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562104|NCT00101816|O2|Outcome|MCyR|Participants acheiving MCyR, defined as the rate of CCyR plus the rate of Partial Cytogenetic Response
562105|NCT00101816|O1|Outcome|MaHR|Participants acheiving MaHR, defined as best confirmed response of Complete Hematologic Response (CHR) or No Evidence of Leukemia (NEL) of Minore Hematologic Response (MiHR)
562106|NCT00101816|O3|Outcome|Total|
562107|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562108|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562109|NCT00101816|O3|Outcome|Total|
562110|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562111|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562112|NCT00101816|O3|Outcome|Total|
562144|NCT00101686|P1|Participant Flow|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
562145|NCT00101686|O5|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562146|NCT00101686|O4|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562147|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562148|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562149|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562113|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562114|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562115|NCT00101816|O2|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response (MaHR or MiHR).
562116|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
562117|NCT00101816|O1|Outcome|Participants Acheiving OHR|OHR=best confirmed response of major or minor hematologic response
562118|NCT00101816|O1|Outcome|Participants Acheiving MaHR|MaHR=best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
562119|NCT00101816|O3|Outcome|Total|
562120|NCT00101816|O2|Outcome|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562121|NCT00101816|O1|Outcome|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562122|NCT00101816|E2|Reported Event|Imatinib-resistant|Defined as any of the following: i) Subjects initially diagnosed with chronic phase chronic myeloid leukemia (CML) who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥400 mg/day. ii) Subjects initially diagnosed with accelerated phase CML who progressed to myeloid phase CML while on treatment with a prescribed imatinib dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). iii) Subjects initially diagnosed with myeloid blast phase CML who meet the criteria for myeloid phase blast crisis after at least 4 weeks of treatment prescribed at a dose of ≥600 mg/day (or 400 to <600 mg/day if subject is intolerant of ≥600 mg/day). Each of these definitions includes subjects who had no response to imatinib (primary resistance) and those who responded and subsequently progressed to myeloid blast phase (acquired resistance). Oral dasatinib 70 mg BID, with dose modifications as necessary to manage disease progression or toxicity.
562123|NCT00101816|E1|Reported Event|Imatinib-intolerant|Defined as: i) Toxicity that was considered at least possibly related to imatinib ≤400 mg/day that led to a discontinuation of imatinib therapy ii) Ability to tolerate only <400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses was not considered imatinib-intolerant. Receiving oral dasatinib at a starting dose of 70 mg twice daily (BID), with dose modifications as necessary for the management of disease progression or toxicity.
562124|NCT00101686|B11|Baseline|Total|Total of all reporting groups
562125|NCT00101686|B10|Baseline|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
562126|NCT00101686|B9|Baseline|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
562127|NCT00101686|B8|Baseline|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
562128|NCT00101686|B7|Baseline|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
562129|NCT00101686|B6|Baseline|CapeIRI + Placebo|Irinotecan plus capecitabine (CapeIRI) with placebo
562130|NCT00101686|B5|Baseline|CapeIRI + Celecoxib|Irinotecan plus capecitabine (CapeIRI) with celecoxib
562131|NCT00101686|B4|Baseline|mIFL + Placebo|Modified irinotecan plus bolus 5-FU/LV (mIFL) with placebo
562132|NCT00101686|B3|Baseline|mIFL + Celecoxib|Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
562133|NCT00101686|B2|Baseline|FOLFIRI + Placebo|Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
562134|NCT00101686|B1|Baseline|FOLFIRI + Celecoxib|Irinotecan plus infusional 5-Fluorouracil(5-FU)/Leucovorin(LV) (FOLFIRI) with celecoxib
562135|NCT00101686|P10|Participant Flow|Bevacizumab + mIFL + Placebo|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL)with placebo
562136|NCT00101686|P9|Participant Flow|Bevacizumab + mIFL + Celecoxib|Bevacizumab + Modified irinotecan plus bolus 5-FU/LV (mIFL) with celecoxib
562137|NCT00101686|P8|Participant Flow|Bevacizumab + FOLFIRI + Placebo|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with placebo
562138|NCT00101686|P7|Participant Flow|Bevacizumab + FOLFIRI + Celecoxib|Bevacizumab + Irinotecan plus infusional 5-FU/LV (FOLFIRI) with celecoxib
562154|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562155|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562156|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562157|NCT00101686|O2|Outcome|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562158|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562159|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562160|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562161|NCT00101686|O2|Outcome|Bevacizumab + mIFL|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562162|NCT00101686|O1|Outcome|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562163|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
562164|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
562165|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
562166|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
562167|NCT00101686|O2|Outcome|Placebo|All patients treated with placebo: combined patients treated with FOLFIRI+placebo, mIRI+placebo, CapeIRI+placebo
562168|NCT00101686|O1|Outcome|Celecoxib|All patients treated with celecoxib: combined patients treated with FOLFIRI+ celecoxib, mIRI+ celecoxib, CapeIRI+ celecoxib
562169|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562170|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562171|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562172|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562173|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562174|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562175|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562176|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562177|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562178|NCT00101686|O3|Outcome|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562179|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562180|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562181|NCT00101686|O2|Outcome|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562182|NCT00101686|O1|Outcome|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562183|NCT00101686|E5|Reported Event|Bevacizumab + mIRI|Bevacizumab + Irinotecan + modified-bolus 5-FU/LV with (celecoxib or placebo)
562184|NCT00101686|E4|Reported Event|Bevacizumab + FOLFIRI|Bevacizumab + Irinotecan + infusional 5-FU/LV with (celecoxib or placebo)
562185|NCT00101686|E3|Reported Event|CapeIRI|Irinotecan + oral capecitabine with celecoxib or placebo
562186|NCT00101686|E2|Reported Event|mIFL|Irinotecan + modified-bolus 5-FU/LV with celecoxib or placebo
562187|NCT00101686|E1|Reported Event|FOLFIRI|Irinotecan + infusional 5-FU/LV with celecoxib or placebo
562188|NCT00101660|B3|Baseline|Total|Total of all reporting groups
562189|NCT00101660|B2|Baseline|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
562190|NCT00101660|B1|Baseline|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
562191|NCT00101660|P2|Participant Flow|Imatinib-resistant|Imatinib resistance, acquired or primary. Acquired resistance: participants who achieve major cytogenetic response (MCyR) or complete hematologic response (CHR) on imatinib at any dose prior to progression, defined by 1 of the following: loss of MCyR, loss of CHR, or increasing white blood cell (WBC) count. Primary resistance: participants who never achieve MCyR or CHR at any dose, and meet 1 of the following: continuously increasing WBC count on at least 2 consecutive evaluations at least 2 weeks apart, with the final assessment showing a doubling of WBC from nadir to ≥20,000/mm^3; an absolute increase in WBC by more than 50,000/mm^3 above lowest count after starting imatinib; no CHR after 3 months; no cytogenetic response (CyR) after 6 months; or no MCyR after 12 months. Resistance was also defined as chronic myeloid leukemia (CML) with resistance to imatinib ≤600mg/d with genetic mutation in BCR-ABL gene (L248V, G250E, Q252H/R, Y253H/F, E255K/V, T315I/D, F317L, H369P/R).
562192|NCT00101660|P1|Participant Flow|Imatinib-intolerant|Imatinib intolerance was defined as: Grade 3 or greater nonhematologic toxicity that is imatinib-related or Grade 4 hematologic toxicity that is imatinib-related lasting more than 7 days.
562193|NCT00101660|O1|Outcome|Dasatinib|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562232|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562233|NCT00101647|O3|Outcome|Total|
562194|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|"Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.~a"
562195|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562196|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562197|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562198|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562199|NCT00101660|O1|Outcome|Dasatinib,70 mg BID|Dasatanib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562200|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg twice BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562201|NCT00101660|O1|Outcome|Dasatinib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562202|NCT00101660|O1|Outcome|Dasatanib, 70 mg BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562203|NCT00101660|O1|Outcome|Dastinib, 70 mg, BID|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562204|NCT00101660|O1|Outcome|Dasatinib, 70 mg, Twice Daily (BID)|Dasatinib, 70 mg BID, with dose escalation to 90 mg BID was allowed for participants who showed evidence of progression or lack of response. Up to 2 dose reductions were allowed for intolerance.
562205|NCT00101660|E2|Reported Event|Resistant|
562206|NCT00101660|E1|Reported Event|Intolerant|
562207|NCT00101647|B3|Baseline|Total|Total of all reporting groups
562208|NCT00101647|B2|Baseline|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
562209|NCT00101647|B1|Baseline|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
562210|NCT00101647|P2|Participant Flow|Imatinib-resistant|Defined as any of the following: i) initial diagnosis of chronic phase of chronic myeloid leukemia (CML) that progressed to accelerated phase while on treatment with imatinib ≥ 400 mg/day (primary or acquired resistance); ii) initial diagnosis of accelerated phase CML and failure to achieve a hematologic response after ≥ 4 weeks (or ≥ 2 weeks for subjects showing rapid disease progression) of imatinib ≥ 600 mg/day; the required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant to ≥ 600 mg/day (primary resistance); iii) initial diagnosis of accelerated or blast phase CML that progressed to accelerated phase CML following an initial hematologic response to imatinib ≥ 600 mg/day (acquired resistance). The required prior imatinib dose was 400 to < 600 mg/day if the subject was intolerant of ≥ 600 mg/day.
562211|NCT00101647|P1|Participant Flow|Imatinib-intolerant|Defined as either: i) toxicity that was considered at least possibly related to imatinib ≤ 400 mg/day that led to a discontinuation of imatinib therapy; ii) ability to tolerate only < 400 mg/day imatinib. A subject who tolerated 400 mg/day imatinib, but was intolerant of higher doses, was not considered imatinib-tolerant.
562212|NCT00101647|O3|Outcome|Total|
562213|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562214|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562215|NCT00101647|O2|Outcome|Day 8|
562216|NCT00101647|O1|Outcome|Day 1|
562217|NCT00101647|O2|Outcome|Day 8|
562218|NCT00101647|O1|Outcome|Day 1|
562219|NCT00101647|O2|Outcome|Day 8|
562220|NCT00101647|O1|Outcome|Day 1|
562221|NCT00101647|O2|Outcome|Study Day 8|
562222|NCT00101647|O1|Outcome|Study Day 1|
562223|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562224|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
562225|NCT00101647|O3|Outcome|Total|
562226|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562227|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562228|NCT00101647|O2|Outcome|Participants Achieving MCyR|Percentage of participants achieving major cytogenetic response (MCyR), defined as the rate of complete cytogenetic response (CCyR) plus the rate of partial cytogenetic response (PCyR).
562229|NCT00101647|O1|Outcome|Participants Achieving MaHR|Percentage of participants achieving MaHR, defined as best confirmed response of complete hematologic response (CHR) or No Evidence of Leukemia (NEL)
562230|NCT00101647|O3|Outcome|Total|
562231|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562235|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562236|NCT00101647|O3|Outcome|Total|
562237|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562238|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562239|NCT00101647|O3|Outcome|Total|
562240|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562241|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562242|NCT00101647|O3|Outcome|Total|
562243|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562244|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562245|NCT00101647|O3|Outcome|Total|
562246|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562247|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562248|NCT00101647|O2|Outcome|Total|
562249|NCT00101647|O1|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562250|NCT00101647|O3|Outcome|Total|
562251|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562252|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg BID
562253|NCT00101647|O3|Outcome|Total|
562254|NCT00101647|O2|Outcome|Imatinib-resistant|Receiving dasatinib 70 mg BID
562255|NCT00101647|O1|Outcome|Imatinib-intolerant|Receiving dasatinib 70 mg twice daily (BID)
562256|NCT00101647|E2|Reported Event|Resistant|
562257|NCT00101647|E1|Reported Event|Intolerant|
562258|NCT00101582|B3|Baseline|Total|Total of all reporting groups
562259|NCT00101582|B2|Baseline|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562260|NCT00101582|B1|Baseline|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562261|NCT00101582|P2|Participant Flow|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
562262|NCT00101582|P1|Participant Flow|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course. Chemotherapy consisted of 100 mg/m^2 cisplatin administered by IV infusion on Days 1, 22, and 43.
562263|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562264|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562265|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562266|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562267|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562268|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562269|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562270|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562271|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562272|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562273|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562274|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562275|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562276|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562277|NCT00101582|O2|Outcome|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562278|NCT00101582|O1|Outcome|Placebo|Participants received a single IV dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562279|NCT00101582|E2|Reported Event|Palifermin|Participants received a single intravenous dose of palifermin at 180 μg/kg three days before the start of radiotherapy, and then 7 once weekly palifermin doses at the same dose level during a 7-week radiotherapy/chemotherapy course.
562280|NCT00101582|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo three days before the start of radiotherapy, and then 7 once weekly placebo doses during a 7-week radiotherapy/chemotherapy course.
562281|NCT00102440|B4|Baseline|Total|Total of all reporting groups
562282|NCT00102440|B3|Baseline|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562283|NCT00102440|B2|Baseline|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562284|NCT00102440|B1|Baseline|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562285|NCT00102440|P3|Participant Flow|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562286|NCT00102440|P2|Participant Flow|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562287|NCT00102440|P1|Participant Flow|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562288|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562289|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562290|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562291|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562292|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562293|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562294|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562295|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562296|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562297|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562298|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562299|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562300|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562301|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562302|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562303|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562304|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562305|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562306|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562307|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562308|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562309|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562310|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562311|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562312|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562313|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562314|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562315|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562316|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562317|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562318|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562319|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562320|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562321|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562322|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562323|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562324|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562325|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562326|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562327|NCT00102440|O3|Outcome|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562328|NCT00102440|O2|Outcome|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562329|NCT00102440|O1|Outcome|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562330|NCT00102440|E3|Reported Event|Allopurinol 300 mg QD|Allopurinol 300 mg, orally, once daily for up to 52 weeks.
562331|NCT00102440|E2|Reported Event|Febuxostat 120 mg QD|Febuxostat 120 mg, orally, once daily for up to 52 weeks.
562332|NCT00102440|E1|Reported Event|Febuxostat 80 mg QD|Febuxostat 80 mg, orally, once daily for up to 52 weeks.
562333|NCT00102063|B4|Baseline|Total|Total of all reporting groups
562334|NCT00102063|B3|Baseline|Placebo Group|Participants were given a single pill administered once daily
562483|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562335|NCT00102063|B2|Baseline|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562336|NCT00102063|B1|Baseline|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562337|NCT00102063|P3|Participant Flow|Placebo Group|Participants were given a single pill administered once daily
562338|NCT00102063|P2|Participant Flow|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562339|NCT00102063|P1|Participant Flow|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562340|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562341|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562342|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562343|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562344|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562345|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562346|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562347|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562348|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562349|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562350|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562351|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562352|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562353|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562354|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562355|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562356|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562357|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562358|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562359|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562360|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562361|NCT00102063|O3|Outcome|Placebo Group|Participants were given a single pill administered once daily
562362|NCT00102063|O2|Outcome|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562363|NCT00102063|O1|Outcome|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562364|NCT00102063|E3|Reported Event|Placebo Group|Participants were given a single pill administered once daily
562365|NCT00102063|E2|Reported Event|Aripiprazole 30 mg/Day Group|Dose was titrated to a target dose of 30 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5, 15 mg/day on Day 7, 20 mg/day on Day 9, and 30 mg/day on Day 11; one dose reduction to 15 mg/day allowed after Day 25
562484|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562366|NCT00102063|E1|Reported Event|Aripiprazole 10 mg/Day Group|Dose was titrated to a target dose of 10 mg/day as follows: starting dose 2 mg/day, increased to 5 mg/day on Day 3, 10 mg/day on Day 5; one dose reduction to 5 mg/day allowed after Day 25
562367|NCT00101933|B3|Baseline|Total|Total of all reporting groups
562368|NCT00101933|B2|Baseline|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562369|NCT00101933|B1|Baseline|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562370|NCT00101933|P2|Participant Flow|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562371|NCT00101933|P1|Participant Flow|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562372|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562373|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562374|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562375|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562376|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562377|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562378|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562379|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562380|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562381|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562382|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562383|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562384|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
562385|NCT00101933|O1|Outcome|All Implanted Subjects|This group contains all subjects who were implanted. This includes one additional subject over those that were randomized.
562386|NCT00101933|O2|Outcome|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562387|NCT00101933|O1|Outcome|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562388|NCT00101933|E2|Reported Event|No Stimulation|This group contains subjects who were implanted and randomized to receive no stimulation during the blinded phase of the study.
562389|NCT00101933|E1|Reported Event|Active Stimulation|This group contains subjects who were implanted and randomized to receive active stimulation during the blinded phase of the study.
562390|NCT00101907|B7|Baseline|Total|Total of all reporting groups
562391|NCT00101907|B6|Baseline|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562392|NCT00101907|B5|Baseline|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562393|NCT00101907|B4|Baseline|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562394|NCT00101907|B3|Baseline|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562395|NCT00101907|B2|Baseline|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562396|NCT00101907|B1|Baseline|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg on Day 1 + gemcitabine (gem) 1250 mg/m^2 on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 on Day 1 of each 3-week cycle.
562397|NCT00101907|P6|Participant Flow|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562398|NCT00101907|P5|Participant Flow|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562399|NCT00101907|P4|Participant Flow|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562400|NCT00101907|P3|Participant Flow|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562485|NCT00101413|E1|Reported Event|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562401|NCT00101907|P2|Participant Flow|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562402|NCT00101907|P1|Participant Flow|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
562403|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562404|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562405|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562406|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562407|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562408|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
562409|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562410|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562411|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562412|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562413|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562414|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562415|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562416|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562417|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562418|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562419|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562420|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562421|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562422|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562423|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562424|NCT00101907|O5|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562425|NCT00101907|O4|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562426|NCT00101907|O3|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562427|NCT00101907|O2|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562428|NCT00101907|O1|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562429|NCT00101907|O6|Outcome|75 mg BID AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562430|NCT00101907|O5|Outcome|125 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562431|NCT00101907|O4|Outcome|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562432|NCT00101907|O3|Outcome|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562433|NCT00101907|O2|Outcome|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg intravenously on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562434|NCT00101907|O1|Outcome|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
562435|NCT00101907|E6|Reported Event|75 mg BID AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 75 mg administered orally twice daily (BID) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562436|NCT00101907|E5|Reported Event|125 mg QD AMG 706 + Panitumumab + Gem/CisEdit|AMG 706 125 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562437|NCT00101907|E4|Reported Event|100 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 100 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562438|NCT00101907|E3|Reported Event|75 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 75 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562439|NCT00101907|E2|Reported Event|50 mg QD AMG 706 + Panitumumab + Gem/Cis|AMG 706 50 mg administered orally once daily (QD) + panitumumab 9 mg/kg on Day 1 + gemcitabine 1250 mg/m^2 on Day 1 and Day 8, and cisplatin 75 mg/m^2 on Day 1 of each 3-week cycle.
562440|NCT00101907|E1|Reported Event|Panitumumab + Gem/Cis|Panitumumab 9 mg/kg intravenously (IV) on Day 1 + gemcitabine (gem) 1250 mg/m^2 IV on Day 1 and Day 8, and cisplatin (cis) 75 mg/m^2 IV on Day 1 of each 3-week cycle.
562441|NCT00101868|B3|Baseline|Total|Total of all reporting groups
562442|NCT00101868|B2|Baseline|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
562443|NCT00101868|B1|Baseline|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
562444|NCT00101868|P2|Participant Flow|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
562445|NCT00101868|P1|Participant Flow|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
562446|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
562447|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
562448|NCT00101868|O2|Outcome|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
562486|NCT00101400|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562487|NCT00101400|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562449|NCT00101868|O1|Outcome|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
562450|NCT00101868|O2|Outcome|Usual Care Discharge, Handwritten|The control intervention was the usual care discharge process. Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post-discharge activities and restrictions, post-discharge diet, post-discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, 1 page of which also included medication instructions and prescriptions.
562451|NCT00101868|O1|Outcome|Discharge Software|Software is computerized-physician-order-entry application for communication at time of hospital discharge to patients, retail pharmacists, and community physicians. Software features included required fields, pick lists, standard drug doses, alerts, reminders, and online reference information. Software prompted discharging physician to enter pending tests and order tests after discharge. Hospital physicians used software on day of discharge and automatically generated 4 discharge documents: personalized letter to outpatient physician with discharge diagnoses, reconciled medication list, diet-activity instructions, patient education materials provided, and follow-up appointments-studies; printed legible prescriptions with information for dispensing pharmacist about changes-deletions in patient's previous regimen; patient instructions with addresses and telephone numbers for follow-up appointments and tests; and printed legible discharge order with aforementioned information.
562452|NCT00101868|E2|Reported Event|Usual Care Discharge Process|Hospital physicians and ward nurses completed handwritten discharge forms on the day of discharge. The forms contained blanks for discharge diagnoses, discharge medications, medication instructions, post discharge activities and restrictions, post discharge diet, post discharge diagnostic and therapeutic interventions, and appointments. Patients received handwritten copies of the forms, one page of which also included medication instructions and prescriptions
562453|NCT00101868|E1|Reported Event|Discharge Communication Software|Computerized-Physician-Order-Entry software application to facilitate communication at time of hospital discharge to patients, retail pharmacists, community physicians. Software had required fields, pick lists, standard drug doses, alerts, reminders, online reference information. Software prompted discharging physician to enter pending tests, order tests after discharge. Hospital physicians used software on day of discharge to generate four documents automatically: personalized letter to outpatient physician, legible prescriptions, and legible discharge order
562454|NCT00101452|B4|Baseline|Total|Total of all reporting groups
562455|NCT00101452|B3|Baseline|3. Placebo|Sugar Pill- contains no active ingrediants
562456|NCT00101452|B2|Baseline|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
562457|NCT00101452|B1|Baseline|1. SAMe|a naturally occurring substance
562458|NCT00101452|P3|Participant Flow|3. Placebo|Placebo is a non-active treatment, sometimes called a sugar pill.
562459|NCT00101452|P2|Participant Flow|2. Escitalopram|Patients start with 10mg/day for the first 6 weeks. If they do not feel better after 6 weeks, they can increase to 20mg/day.
562460|NCT00101452|P1|Participant Flow|1. SAMe|Patients start with 1600mg/day for the first. If they do not feel better after 6 weeks, they may increase to 3200mg/day if their lab tests are normal.
562461|NCT00101452|O3|Outcome|3. Placebo|Sugar Pill- contains no active ingrediants
562462|NCT00101452|O2|Outcome|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
562463|NCT00101452|O1|Outcome|1. SAMe|a naturally occurring substance
562464|NCT00101452|E3|Reported Event|3. Placebo|Sugar Pill- contains no active ingrediants
562465|NCT00101452|E2|Reported Event|2. Escitalopram|A selective serotonin reuptake inhibitor (SSRI)
562466|NCT00101452|E1|Reported Event|1. SAMe|a naturally occurring substance
562467|NCT00101439|B3|Baseline|Total|Total of all reporting groups
562468|NCT00101439|B2|Baseline|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
562469|NCT00101439|B1|Baseline|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
562470|NCT00101439|P2|Participant Flow|Placebo→ Ezetimibe|After a 2-week single- blind placebo run-in, participants will receive placebo once daily for 4 weeks and then receive ezetimibe10 mg once daily for 4 weeks.
562471|NCT00101439|P1|Participant Flow|Ezetimibe→Placebo|After a 2-week single- blind placebo run-in, participants will receive ezetimibe 10 mg once daily for 4 weeks and then receive placebo once daily for 4 weeks.
562472|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
562473|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
562474|NCT00101439|O2|Outcome|Placebo|Participants who received placebo in active treatment period regardless of randomly assigned sequence
562475|NCT00101439|O1|Outcome|Ezetimibe|Participants who received ezetimibe 10 mg in active treatment period regardless of randomly assigned sequence
562476|NCT00101439|E2|Reported Event|Placebo|Participants received placebo once daily for 4 weeks
562477|NCT00101439|E1|Reported Event|Ezetimibe|Participants received 10 mg ezetimibe once daily for 4 weeks
562478|NCT00101413|B1|Baseline|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562479|NCT00101413|P1|Participant Flow|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562480|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562481|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562482|NCT00101413|O1|Outcome|Sorafenib|Sorafenib (Nexavar, BAY43-9006) 400 mg twice daily (bid, bis in die) X 28 day cycles
562488|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562489|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562490|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562491|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562492|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562493|NCT00101400|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562494|NCT00101400|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)|Sorafenib 400 mg administered twice daily (b.i.d.)
562495|NCT00101361|B3|Baseline|Total|Total of all reporting groups
562496|NCT00101361|B2|Baseline|Placebo|placebo
562497|NCT00101361|B1|Baseline|Oxandrolone|Oxandrolone
562498|NCT00101361|P2|Participant Flow|2 Placebo|placebo - two capsules twice daily
562499|NCT00101361|P1|Participant Flow|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
562500|NCT00101361|O2|Outcome|2 Placebo|placebo - two capsules twice daily
562501|NCT00101361|O1|Outcome|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
562502|NCT00101361|E2|Reported Event|2 Placebo|placebo - two capsules twice daily
562503|NCT00101361|E1|Reported Event|1 Oxandrolone|oxandrolone - two 5mg capsules twice daily
562504|NCT00101283|B3|Baseline|Total|Total of all reporting groups
562505|NCT00101283|B2|Baseline|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562506|NCT00101283|B1|Baseline|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562507|NCT00101283|P2|Participant Flow|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562508|NCT00101283|P1|Participant Flow|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562509|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562510|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562511|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562512|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562513|NCT00101283|O2|Outcome|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562514|NCT00101283|O1|Outcome|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562515|NCT00101283|E2|Reported Event|Pemetrexed/Gemcitabine|Pemetrexed disodium 500 mg/m2 IV over 10 minutes on day 1 and gemcitabine 1000 mg/m2 IV over 30 minutes on days 1 and 8 of a 21-day cycle.
562516|NCT00101283|E1|Reported Event|Pemetrexed/Carboplatin|Pemetrexed disodium 500 mg/m2 IV over 10 minutes and carboplatin to AUC 5 IV over 30 minutes on day 1 of a 21-day cycle.
562517|NCT00101192|B1|Baseline|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
562518|NCT00101192|P1|Participant Flow|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
562519|NCT00101192|O1|Outcome|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
562520|NCT00101192|E1|Reported Event|Cetuximab|Cetuximab weekly (Cycle 1, day 1 initial loading dose of 400 mg/m2 IV. All subsequent Cetuximab doses are 250 mg/m2 IV) combined with Cisplatin on day 1 and day 8 (30 mg/m2) (one cycle will be three weeks) until disease progression or adverse effects prohibit further therapy.
562521|NCT00101166|B1|Baseline|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562522|NCT00101166|P1|Participant Flow|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562523|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562524|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562525|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562526|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562527|NCT00101166|O1|Outcome|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562528|NCT00101166|E1|Reported Event|Vaccine Therapy|"Treatment consisted of intradermal vaccine injections at 28-day intervals for a total of 3 immunizations. Injections were performed on Days 1, 29, and 57.~Bystander-Based Autologous Tumor Cell Vaccine : The vaccine, consisting of one mL of cell suspension (GM.CD40L bystander cells admixed with an equivalent number of thawed autologous tumor cells), was administered into 8 separate injection sites, as described in treatment arm."
562529|NCT00101101|B1|Baseline|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562530|NCT00101101|P1|Participant Flow|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562531|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562532|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562533|NCT00101101|O1|Outcome|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562534|NCT00101101|E1|Reported Event|Vaccine and Conventional Therapy|"Patients were treated with 3-6 cycles of chemotherapy +/- rituximab, with type and duration at the discretion of the individual clinician.~Chemotherapy: 6 courses of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) OR 3 courses of hyperfractionated cyclophosphamide, vincristine, doxorubicin, and dexamethasone alternating with high-dose methotrexate and cytarabine (hyper-CVAD) for patients who have relapsed after CHOP.~Patients who achieve a partial or complete response after completion of chemotherapy proceed to autologous tumor cell-based vaccine therapy.~Patients who have stable or responding disease at 12 months receive 4 additional courses of booster vaccine and low-dose IL-2.~Treatment continues in the absence of disease progression or unacceptable toxicity."
562535|NCT00101036|B3|Baseline|Total|Total of all reporting groups
562536|NCT00101036|B2|Baseline|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562537|NCT00101036|B1|Baseline|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562538|NCT00101036|P2|Participant Flow|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562539|NCT00101036|P1|Participant Flow|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562540|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562541|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562542|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562543|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562544|NCT00101036|O2|Outcome|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562545|NCT00101036|O1|Outcome|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562546|NCT00101036|E2|Reported Event|Arm 2|GW572016 1500 mg orally daily for 28 days, HCC strata
562547|NCT00101036|E1|Reported Event|Arm 1|GW572016 1500 mg orally daily for 28 days, Biliary strata
562548|NCT00100932|B3|Baseline|Total|Total of all reporting groups
562549|NCT00100932|B2|Baseline|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562550|NCT00100932|B1|Baseline|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562551|NCT00100932|P2|Participant Flow|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562552|NCT00100932|P1|Participant Flow|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562553|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562554|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562555|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562556|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562557|NCT00100932|O2|Outcome|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562558|NCT00100932|O1|Outcome|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562559|NCT00100932|E2|Reported Event|E7389 21 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
562560|NCT00100932|E1|Reported Event|E7389 28 Day Cycle|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
562561|NCT00100841|B1|Baseline|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
562562|NCT00100841|P1|Participant Flow|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
562563|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
562564|NCT00100841|O1|Outcome|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
562565|NCT00100841|E1|Reported Event|Treatment (Combination Chemotherapy)|"Patients receive cetuximab IV over 60-120 minutes on day 1 in weeks 1-8. Patients also receive bevacizumab IV over 30-90 minutes, oxaliplatin IV over 2 hours, and leucovorin calcium IV over 2 hours on day 1, and fluorouracil IV continuously over 48 hours on days 1 and 2 of weeks 1, 3, 5, and 7. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.~cetuximab: Given IV~bevacizumab: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
562566|NCT00100815|B1|Baseline|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562567|NCT00100815|P1|Participant Flow|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562568|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562569|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562570|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562571|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562572|NCT00100815|O1|Outcome|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562573|NCT00100815|E1|Reported Event|GEMCITABINE, CAPECITABINE and AVASTIN|Avastin 15 mg/ kg q 3 weeks, starting day 1; capecitabine 650 mg/m2 bid x 14 days starting day 1, gemcitabine 1000 mg/m2 days 1 and 8, cycles to be repeated q 21 days.
562597|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562574|NCT00100802|B1|Baseline|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
562575|NCT00100802|P1|Participant Flow|Surgery, Chemoradiotherapy, Rest, Maintenance, Follow-up|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
562576|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
562577|NCT00100802|O1|Outcome|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
562578|NCT00100802|E1|Reported Event|Surgery, Chemoradiotherapy, Rest, Maintenance, FUP|"Patients must begin therapy within 31 days of surgery. Chemoradiotherapy = Radiation Therapy Dose: 54.0 Gy with a Boost of 5.4 Gy Temozolomide 90mg/m2/day daily for 42 days. Maintenance consists of 6 treatment cycles of combo chemotherapy with lomustine and temozolomide. Maintenance will begin 4 weeks following radiation. Five days of temozolomide (day 1 - 5) and one dose of lomustine (day 1) followed by 36 days of rest = 1 treatment cycle.~lomustine: Capsule~temozolomide: Capsule~adjuvant therapy~radiation therapy"
562579|NCT00100789|B1|Baseline|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
562580|NCT00100789|P1|Participant Flow|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
562581|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
562582|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR. Eligible patients who received any treatment were included in baseline measures.
562583|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
562584|NCT00100789|O1|Outcome|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
562585|NCT00100789|E1|Reported Event|Gemcitabine and Paclitaxel|Patients received Gemcitabine 3,000 mg/m2 (IV on days 1 and 15 over 30 minutes) and Paclitaxel 150 mg/m2 (IV on days 1 and 15 over one hour). Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 4 additional courses beyond CR.
562586|NCT00100698|B3|Baseline|Total|Total of all reporting groups
562587|NCT00100698|B2|Baseline|Placebo|placebo subcutaneously once a day
562588|NCT00100698|B1|Baseline|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562589|NCT00100698|P2|Participant Flow|Placebo|placebo subcutaneously once a day
562590|NCT00100698|P1|Participant Flow|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562591|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562592|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562593|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562594|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562595|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562596|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562598|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562599|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562600|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562601|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562602|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562603|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562604|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562605|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562606|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562607|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562608|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562609|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562610|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562611|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562612|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562613|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562614|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562615|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562616|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562617|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562618|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562619|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562620|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562621|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562622|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562623|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562624|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562625|NCT00100698|O2|Outcome|Placebo|placebo subcutaneously once a day
562626|NCT00100698|O1|Outcome|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562627|NCT00100698|E2|Reported Event|Placebo|placebo subcutaneously once a day
562628|NCT00100698|E1|Reported Event|Recombinant Human Growth Hormone|recombinant human growth hormone starting at 2 micrograms/kilograms/day subcutaneously and increased to maximum dose of 6 micrograms/kilograms/day subcutaneously
562629|NCT00100659|B3|Baseline|Total|Total of all reporting groups
562630|NCT00100659|B2|Baseline|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
562631|NCT00100659|B1|Baseline|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
562632|NCT00100659|P2|Participant Flow|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
562633|NCT00100659|P1|Participant Flow|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
562634|NCT00100659|O2|Outcome|PEG/Placebo|Pegylated interferon/placebo
562635|NCT00100659|O1|Outcome|PEG/RV|Pegylated interferon/ribavirin
562636|NCT00100659|E2|Reported Event|Pegylated Interferon/Placebo|Placebo tablets were supplied in the same dosing regimen as ribavirin, using the same number of tablets that would be given if ribavirin were being administered (eg, 3 placebo tablets twice daily for a 40-kg child who would receive 3 100-mg RV tablets twice daily).
562637|NCT00100659|E1|Reported Event|Pegylated Interferon/Ribavirin|"Pegasys - 180 mcg per 1.73 meter squared body surface area subcutaneously once weekly.~Ribavirin - 15 mg per kg orally twice daily using 100-mg tablets."
562638|NCT00099632|B7|Baseline|Total|Total of all reporting groups
562639|NCT00099632|B6|Baseline|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562640|NCT00099632|B5|Baseline|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562641|NCT00099632|B4|Baseline|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562642|NCT00099632|B3|Baseline|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562643|NCT00099632|B2|Baseline|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562644|NCT00099632|B1|Baseline|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562645|NCT00099632|P6|Participant Flow|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562646|NCT00099632|P5|Participant Flow|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562647|NCT00099632|P4|Participant Flow|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562648|NCT00099632|P3|Participant Flow|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562649|NCT00099632|P2|Participant Flow|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562650|NCT00099632|P1|Participant Flow|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562651|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562652|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562653|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562654|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562655|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562656|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562657|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562658|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562659|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562660|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562661|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562662|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562663|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562664|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562665|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562666|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562667|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562668|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562669|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562670|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562671|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562672|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562673|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562674|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562675|NCT00099632|O6|Outcome|21-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562676|NCT00099632|O5|Outcome|7-day Lopinavir/Ritonavir (LPV/r)|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r.
562677|NCT00099632|O4|Outcome|21-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF.
562678|NCT00099632|O3|Outcome|7-day Emtricitabine/Tenofovir Disoproxil Fumarate (FTC/TDF)|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF.
562679|NCT00099632|O2|Outcome|21-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV.
562680|NCT00099632|O1|Outcome|7-day Lamivudine/Zidovudine (3TC/ZDV)|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV.
562681|NCT00099632|E6|Reported Event|21-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 21 days of LPV/r
562682|NCT00099632|E5|Reported Event|7-day LPV/r|SD NVP and LPV/r provided at onset of active labor, followed by 7 days of LPV/r
562683|NCT00099632|E4|Reported Event|21-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 21 days of FTC/TDF
562684|NCT00099632|E3|Reported Event|7-day FTC/TDF|SD NVP and FTC/TDF provided at onset of active labor, followed by 7 days of FTC/TDF
562685|NCT00099632|E2|Reported Event|21-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 21 days of 3TC/ZDV
562686|NCT00099632|E1|Reported Event|7-day 3TC/ZDV|SD NVP and 3TC/ZDV provided at onset of active labor, followed by 7 days of 3TC/ZDV
562687|NCT00100230|B3|Baseline|Total|Total of all reporting groups
562688|NCT00100230|B2|Baseline|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
562689|NCT00100230|B1|Baseline|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
562690|NCT00100230|P2|Participant Flow|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
562691|NCT00100230|P1|Participant Flow|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
562692|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil) ARM|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562693|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid) ARM|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562694|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562695|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562696|NCT00100230|O2|Outcome|Placebo (Corn/Soy Oil)|"corn/soy oil placebo; oil not containing DHA...dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562697|NCT00100230|O1|Outcome|DHA (Docosahexaenoic Acid)|"Oral Docosahexaenoic acid, dosage based on body weight~docosahexaenoic acid OR corn/soy oil placebo: daily intake of DHA based on body weight or corn/soy oil placebo(oil not containing DHA; 4 year trial"
562698|NCT00100230|E2|Reported Event|Corn/Soy Oil Placebo Arm|Corn/soy oil placebo (oils not containing DHA); dosage based on body weight for 4-year trial
562699|NCT00100230|E1|Reported Event|1. Docosahexaenoic Acid (DHA) Arm|Docosahexaenoic acid (an omega-3 polyunsaturated fatty acid) taken orally at a dosage of 30 mg/kg body weight/day for a 4-year duration trial.
562700|NCT00100178|B4|Baseline|Total|Total of all reporting groups
562701|NCT00100178|B3|Baseline|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
562702|NCT00100178|B2|Baseline|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND saline intravenous infusions given at baseline and two weeks later
562703|NCT00100178|B1|Baseline|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years AND DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later.
562704|NCT00100178|P3|Participant Flow|MMF-DZB Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
562705|NCT00100178|P2|Participant Flow|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
562706|NCT00100178|P1|Participant Flow|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
562707|NCT00100178|O3|Outcome|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
562708|NCT00100178|O2|Outcome|Placebo Control|Placebo pills given daily for two years and saline intravenous infusions given at baseline and two weeks later.
562709|NCT00100178|O1|Outcome|MMF and DZB|DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later, and 600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years.
562710|NCT00100178|E3|Reported Event|MMF-DZB Placebo Control|Placebo pills given daily for two years AND saline intravenous infusions given at baseline and two weeks later.
562711|NCT00100178|E2|Reported Event|MMF Alone|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and saline intravenous infusions given at baseline and two weeks later.
562712|NCT00100178|E1|Reported Event|MMF and DZB|600 mg/m2 (2000 mg/day maximum) in 2-3 divided doses for 2 years and DZB given by intravenous infusion (1 mg/kg)at baseline and 2 weeks later .
562713|NCT00100048|B6|Baseline|Total|Total of all reporting groups
562714|NCT00100048|B5|Baseline|Placebo / Efavirenz 600 mg Once Daily (q.d.)|"Cohort I-Monotherapy Phase (10 Days)~Placebo to MK0518 b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks)~Efavirenz + Tenofovir + Lamivudine"
562715|NCT00100048|B4|Baseline|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine"
562716|NCT00100048|B3|Baseline|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine"
562717|NCT00100048|B2|Baseline|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase (10 Days)~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine"
562718|NCT00100048|B1|Baseline|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase (10 Days)~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d"
562719|NCT00100048|P6|Participant Flow|Efavirenz 600 mg q.h.s.|"Cohort II Combined-Combination Therapy Phase~efavirenz 600 mg every night at bedtime (q.h.s.)"
562720|NCT00100048|P5|Participant Flow|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
562721|NCT00100048|P4|Participant Flow|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562722|NCT00100048|P3|Participant Flow|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562723|NCT00100048|P2|Participant Flow|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562724|NCT00100048|P1|Participant Flow|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562725|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562726|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562727|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562728|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562729|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562730|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562731|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562732|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562733|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562734|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562735|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562736|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562737|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562738|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562739|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562740|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562741|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562742|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
562743|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562744|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562745|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562746|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562747|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
562748|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562749|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562750|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562751|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562752|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562753|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562754|NCT00100048|O2|Outcome|EVF Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562755|NCT00100048|O1|Outcome|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562756|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
562757|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562758|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562759|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562760|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562761|NCT00100048|O2|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562762|NCT00100048|O1|Outcome|MK0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562763|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562764|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562765|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562766|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562767|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562768|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562769|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562770|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562771|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562772|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562773|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562774|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562775|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562776|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562777|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562778|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562779|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562780|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562781|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562782|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562783|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562784|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562785|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562786|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562787|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562788|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562789|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562790|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562791|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562792|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562793|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562794|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562795|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562796|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562797|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562798|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562799|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562800|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562801|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562802|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562803|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562804|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562805|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562806|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562807|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562808|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562809|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562810|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d.~Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562811|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d~Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562812|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)~Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562813|NCT00100048|O5|Outcome|EFV Combo Therapy|"EFV Combo Therapy Phase - Cohort II efavirenz + tenofovir +~lamivudine"
562814|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 600 mg + tenofovir + lamivudine"
562815|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 400 mg + tenofovir + lamivudine"
562816|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort II Combined-Combination Therapy Phase~MK0518 200 mg + tenofovir + lamivudine"
562817|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort II Combined-Combination Therapy Phase~MK0518 100 mg + tenofovir + lamivudine"
562818|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
562819|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
562820|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
562821|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
562822|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
562823|NCT00100048|O5|Outcome|Placebo|"Cohort I-Monotherapy Phase~Placebo to MK0518 b.i.d."
562824|NCT00100048|O4|Outcome|MK0518 600 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 600 mg b.i.d."
562825|NCT00100048|O3|Outcome|MK0518 400 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 400 mg b.i.d."
562826|NCT00100048|O2|Outcome|MK0518 200 mg b.i.d|"Cohort I-Monotherapy Phase~MK0518 200 mg b.i.d"
562827|NCT00100048|O1|Outcome|MK0518 100 mg b.i.d.|"Cohort I-Monotherapy Phase~MK0518 100 mg twice daily (b.i.d.)"
562828|NCT00100048|E2|Reported Event|Efavirenz|"EFV Combo Therapy Phase - Cohort II~efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine~This arm included participants from Cohort I who were randomized to placebo."
562829|NCT00100048|E1|Reported Event|MK-0518 b.i.d.|"Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.~Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine"
562830|NCT00099983|B3|Baseline|Total|Total of all reporting groups
562831|NCT00099983|B2|Baseline|Sugar Pill|"PTSD~Placebo : Placebo"
562832|NCT00099983|B1|Baseline|Risperidone|Risperidone : atypical antipsychotic
562833|NCT00099983|P2|Participant Flow|Sugar Pill|Placebo Sugar Pill 1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day).
562834|NCT00099983|P1|Participant Flow|Risperidone|"an atypical antipsychotic indicated for the treatment of schizophrenia but not for Post Traumatic Stress Disorder (PTSD). Some of additional unlabeled uses of risperidone include behavioral symptoms associated with dementia in the elderly, bipolar disorder, Tourette’s disorder, pervasive developmental disorder and autism.~(1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day)."
562835|NCT00099983|O2|Outcome|Sugar Pill|"Placebo 1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Placebo: Placebo"
562836|NCT00099983|O1|Outcome|Risperidone|"1 mg/day tablet for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day to a maximum of 4 mg/day allowed after a minimum of 4 weeks at the target dose 3 mg/day~Risperidone: Initiate treatment with a low dose (1 mg/day HS) for week one, increasing by 1 mg/day weekly to a target dose of 3 mg/day. Escalation to a maximum of 4 mg/day will be allowed after a minimum of 4 weeks at the target dose (3 mg/day). Reduction to a lower dose will be allowed at any time, based on adverse effects. Treatment will continue for 6 months. Patients who discontinue treatment will be allowed to resume treatment at any time."
562837|NCT00099983|E2|Reported Event|Sugar Pill|"PTSD~Placebo : Placebo"
562838|NCT00099983|E1|Reported Event|Risperidone|Risperidone : atypical antipsychotic
562839|NCT00099437|B3|Baseline|Total|Total of all reporting groups
562840|NCT00099437|B2|Baseline|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562841|NCT00099437|B1|Baseline|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562842|NCT00099437|P2|Participant Flow|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562843|NCT00099437|P1|Participant Flow|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562844|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562845|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562846|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562847|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562848|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562849|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562850|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562851|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562852|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562853|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562854|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562855|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562856|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562857|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562858|NCT00099437|O2|Outcome|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562859|NCT00099437|O1|Outcome|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562860|NCT00099437|E2|Reported Event|Fulvestrant 500 mg|Fulvestrant 500 mg Intramuscular Injection every 28 days plus 500 mg on day 14
562861|NCT00099437|E1|Reported Event|Fulvestrant 250 mg|Fulvestrant 250 mg Intramuscular Injection every 28 days
562862|NCT00099359|B4|Baseline|Total|Total of all reporting groups
562863|NCT00099359|B3|Baseline|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
562864|NCT00099359|B2|Baseline|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
562865|NCT00099359|B1|Baseline|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
562866|NCT00099359|P3|Participant Flow|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
562867|NCT00099359|P2|Participant Flow|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
562868|NCT00099359|P1|Participant Flow|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
562869|NCT00099359|O1|Outcome|ARM B (ZDV + NVP)|NVP concentrations were measured in 14 infants immediately before the 3rd dose, 4 hours post dose, 1 day post dose, 3-5 days post dose and 7 days post dose.
562870|NCT00099359|O2|Outcome|Uninfected|Infants uninfected after birth
562871|NCT00099359|O1|Outcome|Infected|Infants infected after birth
562872|NCT00099359|O1|Outcome|ARM C (ZDV + 3TC/NFV)|Standard ZDV for 6 weeks combined with 2 weeks of 3TC and NFV. NFV and 3TC plasma concentrations were measured by validated HPLC assays with lower detection limit of 0.04 micrograms/mL.
562873|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
562874|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
562875|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
562978|NCT00098748|B2|Baseline|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562876|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC + NFV)|"Standard of Care (Zidovudine) plus 2 weeks of Epivir (3TC) and Nelfinavir (NFV) 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
562877|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|"Standard of care (Zidovudine) plus Nevirapine (NVP)~NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
562878|NCT00099359|O1|Outcome|Arm A (ZDV Only)|Standard of care ( Zidovudine only). 12 mg PO BID if BW>2000 grams ; 8 mg PO BID if BW</= 2000 grams
562879|NCT00099359|O3|Outcome|ARM C (ZDV + 3TC/NFV)|ZDV + 3TC/NFV
562880|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|ZDV + NVP
562881|NCT00099359|O1|Outcome|ARM A (ZDV Only)|ZDV only
562882|NCT00099359|O3|Outcome|ARM C (ZDV +3TC+NFV)|"ZDV (standard of care) plus 3TC, given for 2 weeks:~6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 - 3000 grams 100 mg PO BID if BW < 2000 grams"
562883|NCT00099359|O2|Outcome|ARM B (ZDV + NVP)|plus NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose : 12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams
562884|NCT00099359|O1|Outcome|ARM A (ZDV - Standard of Care)|"ZDV (standard of care), given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
562885|NCT00099359|E3|Reported Event|ARM C (ZDV + 3TC/NFV)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams AND 3TC, given for 2 weeks: 6 mg po bid if BW > 2000 grams 4 mg po bid if BW < 2000 grams AND~NFV, given for 2 weeks:~200 mg po bid if BW > 3000 grams 150 mg po bid if BW > 2,000 – 3000 grams 100 mg PO BID if BW < 2000 grams"
562886|NCT00099359|E2|Reported Event|ARM B (ZDV + NVP)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams~AND NVP, first dose initiated within 48 hrs of birth, second dose 48 hrs (+ 4 hours) after the first dose, and third dose 96 hours (+ 4 hours) after the second dose :~12 mg PO per dose if BW > 2000 grams, 8 mg PO per dose if BW < 2000 grams"
562887|NCT00099359|E1|Reported Event|ARM A (ZDV Alone)|"ZDV, given for 6 weeks:~12 mg PO BID if birthweight (BW) > 2000 grams 8 mg PO BID if BW < 2000 grams"
562888|NCT00099268|B3|Baseline|Total|Total of all reporting groups
562889|NCT00099268|B2|Baseline|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562890|NCT00099268|B1|Baseline|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562891|NCT00099268|P2|Participant Flow|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562892|NCT00099268|P1|Participant Flow|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562893|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562894|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562895|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562896|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562897|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562898|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562899|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562900|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
563499|NCT00097695|P2|Participant Flow|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
562901|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562902|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562903|NCT00099268|O2|Outcome|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562904|NCT00099268|O1|Outcome|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562905|NCT00099268|E2|Reported Event|Carbidopa/Levodopa|Patients received Immediate release carbidopa/levodopa tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562906|NCT00099268|E1|Reported Event|Carbidopa/Levodopa/Entacapone|Patients received Carbidopa/levodopa/entacapone tablets. The study was designed as a flexible dose trial (200-1000 mg/day levodopa). The target dose was 400 mg/day levodopa administered orally as 4 equal doses 4 times a day with 3.5-hour dosing intervals for a treatment period of 134 to 208 weeks.
562907|NCT00099047|B3|Baseline|Total|Total of all reporting groups
562908|NCT00099047|B2|Baseline|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562909|NCT00099047|B1|Baseline|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562910|NCT00099047|P2|Participant Flow|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562911|NCT00099047|P1|Participant Flow|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562912|NCT00099047|O2|Outcome|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562913|NCT00099047|O1|Outcome|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562914|NCT00099047|E2|Reported Event|Arm II (Placebo)|Patients receive placebo PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562915|NCT00099047|E1|Reported Event|Arm I (Celecoxib)|Patients receive celecoxib PO BID for 6 months in the absence of unacceptable toxicity or progression to malignancy.
562916|NCT00099021|B1|Baseline|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562917|NCT00099021|P1|Participant Flow|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562918|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562919|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562920|NCT00099021|O1|Outcome|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562921|NCT00099021|E1|Reported Event|Pioglitazone Patients|Patients with measurable leukoplakia who received all study medication (oral pioglitazone once daily for 12 weeks) and completed the trial.
562922|NCT00098956|B1|Baseline|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
562923|NCT00098956|P1|Participant Flow|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
562924|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
562925|NCT00098956|O1|Outcome|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
562926|NCT00098956|E1|Reported Event|Treatment (Topotecan Hydrochloride, UCN-01)|"Patients receive topotecan IV over 30 minutes on days 1-5 and UCN-01 IV over 3 hours on day 1. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving CR or PR receive 2 additional courses beyond CR or PR.~topotecan hydrochloride: Given IV~7-hydroxystaurosporine: Given IV"
562979|NCT00098748|B1|Baseline|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
565230|NCT00094575|P1|Participant Flow|Endovascular Repair|Endovascular Repair
562927|NCT00098865|B1|Baseline|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
562928|NCT00098865|P1|Participant Flow|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression"
562929|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
562930|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
562931|NCT00098865|O1|Outcome|Thalidomide and Temozolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression~temozolomide: The lower 150/m2 Temozolomide dose was for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal raditation.~thalidomide: Calculated dose was rounded down to the nearest 50mg, or up to 50mg if calculated dose was less than 50mg. Patients increased the daily dose by 50mg (one capsule) on a weekly basis unitl either unacceptable toxicity or a maximum dose."
562932|NCT00098865|E1|Reported Event|Thalidomide and Temzolomide|"Thalidomide:~Oral thalidomide on days 1-28 of a 28 day cycle initiated at 3 mg/kg and increased to maximum dose of 24 mg/kg or 1000 mg as tolerated.~Temozolomide:~Oral temozolomide on days 1-5 of 28 day cycle given at 200 mg/m2 or 150 mg/m2 for patients who had previously received significant therapy to the bone marrow (chemotherapy or radiation) or cranial spinal radiation.~Patients were treated for 6 cycles unless disease progression or excessive toxicity. Treatment could continue beyond 6 cycles if absent disease progression."
562933|NCT00098839|B3|Baseline|Total|Total of all reporting groups
562934|NCT00098839|B2|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562935|NCT00098839|B1|Baseline|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562962|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562963|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562980|NCT00098748|P3|Participant Flow|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562936|NCT00098839|P2|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562937|NCT00098839|P1|Participant Flow|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, high-dose (HD) methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), Intrathecal triple therapy (ITT) (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562938|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562939|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562940|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562941|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562942|NCT00098839|O2|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562943|NCT00098839|O1|Outcome|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562944|NCT00098839|E2|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Twice Weekly|"Eight 8 twice-weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 4, 8, 11, 15, 18, 22 & 25. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562945|NCT00098839|E1|Reported Event|Reinduction Chemoimmunotherapy With Epratuzumab Once Weekly|"Four weekly doses of epratuzumab (360 mg/m2/dose) IV days 1, 8, 15, 22. Also received vincristine sulfate, prednisone, pegaspargase, doxorubicin hydrochloride, dexrazoxane hydrochloride, etoposide, cyclophosphamide, filgrastim, HD methotrexate with Leucovorin calcium rescue, L-asparaginase, cytarabine, IT cytarabine, IT methotrexate (CNS-negative), ITT (methotrexate, cytarabine, therapeutic hydrocortisone for CNS-positive) during the 3 blocks of reinduction therapy.~L-asparaginase: Given IM~doxorubicin hydrochloride: Given IV~therapeutic hydrocortisone: 40 mg/m2/day PO divided BID or TID~vincristine sulfate: Given IV~epratuzumab: Given IV~cytarabine: Given IT~prednisone: Given orally~pegaspargase: Given IM~dexrazoxane hydrochloride: Given IV~methotrexate: Given IT~etoposide: Given IV~cyclophosphamide: Given IV~leucovorin calcium: Given IV~filgrastim: Given SC"
562946|NCT00098813|B1|Baseline|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
562947|NCT00098813|P1|Participant Flow|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
562948|NCT00098813|O1|Outcome|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
562949|NCT00098813|E1|Reported Event|Treatment (Romidepsin)|Patients receive romidepsin IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for up to 12 courses in the absence of unacceptable toxicity or disease progression.
562950|NCT00098787|B4|Baseline|Total|Total of all reporting groups
562951|NCT00098787|B3|Baseline|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562952|NCT00098787|B2|Baseline|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562953|NCT00098787|B1|Baseline|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562954|NCT00098787|P3|Participant Flow|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562955|NCT00098787|P2|Participant Flow|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562956|NCT00098787|P1|Participant Flow|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562957|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562958|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562959|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562960|NCT00098787|O3|Outcome|Arm C (Low or Intermediate TS, FOLFOX/Bev)|Patients with low or intermediate TS receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562961|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562977|NCT00098748|B3|Baseline|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563010|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562964|NCT00098787|O2|Outcome|Arm B (High TS, FOLFOX/Bev)|Patients with high TS who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in Arm A, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562965|NCT00098787|O1|Outcome|Arm A (High TS, IROX/Bev)|Patients with high TS who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562966|NCT00098787|E3|Reported Event|Low or Indeterminate TS: FOLFOX/Bev|Patients with low or intermediate thymidylate synthase (TS) receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev) as in Arm B.
562967|NCT00098787|E2|Reported Event|High TS: FOLFOX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm B receive 5-Fluorouracil, leucovorin, oxaliplatin, and bevacizumab (FOLFOX/bev). The combination regimen is administered by giving bevacizumab and oxaliplatin as in arm I, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes and then continuously over 46 hours on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol is met.
562968|NCT00098787|E1|Reported Event|High TS: IROX/Bev|Patients with high thymidylate synthase (TS) who are randomized to Arm A receive irinotecan and oxaliplatin plus bevacizumab (IROX/bev). The combination regimen is administered by giving bevacizumab IV over 30-90 minutes followed by oxaliplatin IV over 2 hours and irinotecan IV over 90 minutes on days 1 and 15 every 28 days until disease progression or until any criterion specified in protocol.
562969|NCT00098774|B1|Baseline|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562970|NCT00098774|P1|Participant Flow|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562971|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562972|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562973|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562974|NCT00098774|O1|Outcome|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562975|NCT00098774|E1|Reported Event|Intensive Combination Chemo & Immunotherapy|"Induction Cycles 1-3: Methotrexate 8gm/m^2 days 1 & 15; Leucovorin 100 mg/m^2 days 2 & 16; Rituximab 375 mg/m^2 days 3, 10, 17 & 24 of cycle 1, days 3 & 10 of cycle 2; Temozolomide 150 mg/m^2/day PO days 7-11~Induction Cycle 4: Temozolomide 150 mg/m^2/day PO days 7-11; Methotrexate 8gm/m^2 day 15; Leucovorin 100 mg/m^2 day 16~Consolidation Cycle 5: Methotrexate 8gm/m^2 days 1; Leucovorin 100 mg/m^2 days 2; Temozolomide 150 mg/m^2/day PO days 7-11~Consolidation Cycle 6: Cytarabine 2 g/m^2 (x 8 doses) days 1-4; Etoposide 5 mg/kg (x 8 doses) days 1-4; G-CSF 5 mcg/kg/day or GM-CSF 250 mcg/m^2/day starting day 14 until ANC recovers (>= 500 for 2 consecutive days or >= 1500 for one day)"
562976|NCT00098748|B4|Baseline|Total|Total of all reporting groups
563590|NCT00097500|B2|Baseline|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
562981|NCT00098748|P2|Participant Flow|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562982|NCT00098748|P1|Participant Flow|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562983|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562984|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562985|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562986|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562987|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562988|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562989|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562990|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562991|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562992|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562993|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562994|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562995|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562996|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
562997|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
562998|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
562999|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563000|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563001|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563002|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563003|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563004|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563005|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563006|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563007|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563008|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563009|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563641|NCT00096954|B2|Baseline|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563011|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563012|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563013|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563014|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563015|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563016|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563017|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563018|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563019|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563020|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563021|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563022|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563023|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563024|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563025|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563026|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563027|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563028|NCT00098748|O3|Outcome|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563029|NCT00098748|O2|Outcome|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563030|NCT00098748|O1|Outcome|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563031|NCT00098748|E3|Reported Event|Placebo|Placebo BID in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The placebo arm = placebo drug in the morning and evening.
563032|NCT00098748|E2|Reported Event|Maraviroc BID|Maraviroc 150 mg PO twice a day (BID) in combination with OBT (3 to 6 drugs based on treatment history and resistance testing). The 150 mg BID arm = active drug in the morning and evening.
563033|NCT00098748|E1|Reported Event|Maraviroc QD|Maraviroc 150 mg by mouth (PO) once daily (QD) in combination with optimized background therapy (OBT) (3 to 6 drugs based on treatment history and resistance testing). The 150 mg QD arm = placebo drug in the morning and active drug in the evening.
563034|NCT00098722|B4|Baseline|Total|Total of all reporting groups
563035|NCT00098722|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563036|NCT00098722|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563037|NCT00098722|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563038|NCT00098722|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563680|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563681|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563039|NCT00098722|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563040|NCT00098722|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563041|NCT00098722|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563042|NCT00098722|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563043|NCT00098722|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563044|NCT00098722|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563045|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563046|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563047|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563048|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563049|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563050|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563051|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563052|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563053|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563054|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563055|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563056|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563057|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563058|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563500|NCT00097695|P1|Participant Flow|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
563059|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563060|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563061|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563062|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563063|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563064|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563065|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563066|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563067|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563068|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563069|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563070|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563071|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563072|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563073|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563074|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563075|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563076|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563077|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563078|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563079|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563080|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563081|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563082|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563083|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563084|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563085|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563086|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563087|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563088|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563089|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563090|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563091|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563092|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563093|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563094|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563095|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563096|NCT00098722|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563097|NCT00098722|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563098|NCT00098722|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563099|NCT00098722|E7|Reported Event|In Study-off Drug, Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563190|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563100|NCT00098722|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563101|NCT00098722|E5|Reported Event|In Study-off Drug, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563102|NCT00098722|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563103|NCT00098722|E3|Reported Event|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563104|NCT00098722|E2|Reported Event|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563105|NCT00098722|E1|Reported Event|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563106|NCT00098670|B1|Baseline|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563107|NCT00098670|P1|Participant Flow|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563108|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563109|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563110|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563111|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563112|NCT00098670|O1|Outcome|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction in patients with B-cell CLL
563113|NCT00098670|E2|Reported Event|Alemtuzumab Consolidation|Alemtuzumab consolidation following fludarabine and rituximab induction
563114|NCT00098670|E1|Reported Event|FR Induction|Fludarabine and rituximab induction in pts with B-cell CLL
563115|NCT00098475|B3|Baseline|Total|Total of all reporting groups
563116|NCT00098475|B2|Baseline|Arm II (Lenalidomide, Low-dose Dexamethasone)|"Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
563117|NCT00098475|B1|Baseline|Arm I (Lenalidomide, Dexamethasone)|"Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.~As the expansion phase was a substudy terminated early with only 7 patients enrolled, the clinical results presented are mainly for the first phase only. Toxicity data are available for both the first phase and the expansion phase."
563118|NCT00098475|P4|Participant Flow|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
563119|NCT00098475|P3|Participant Flow|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
563120|NCT00098475|P2|Participant Flow|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
563121|NCT00098475|P1|Participant Flow|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
563122|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
563123|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
563124|NCT00098475|O2|Outcome|Arm II (Lenalidomide, Low-dose Dexamethasone)|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
563125|NCT00098475|O1|Outcome|Arm I (Lenalidomide, Dexamethasone)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
563126|NCT00098475|E6|Reported Event|Arm IV (Expansion; Lenalidomide, Dexamethasone, Coumadin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment. For patients continuing therapy beyond 4 cycles, coumadin was discontinued and aspirin was given instead.
563127|NCT00098475|E5|Reported Event|Arm III (Expansion; Lenalidomide, Dexamethasone, Aspirin)|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. After 4 cycles of treatment, patients may discontinue treatment or continue until progression.
563128|NCT00098475|E4|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 2|Arm II patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
563129|NCT00098475|E3|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 2|Arm I patients with minimal response or no response after 4 cycles of treatment in Step 1 could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
563130|NCT00098475|E2|Reported Event|Arm II (Lenalidomide, Low-dose Dexamethasone) Step 1|Patients receive oral lenalidomide and acetylsalicylic acid as in arm I and low-dose oral dexamethasone once daily on days 1, 8, 15, and 22. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and low-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1, 8, 15, and 22 for 4 cycles.
563131|NCT00098475|E1|Reported Event|Arm I (Lenalidomide, Dexamethasone) Step 1|Patients receive oral lenalidomide once daily on days 1-21, oral aspirin (or other deep vein thrombosis prophylaxis at the discretion of the principal investigator) once daily on days 1-28, and standard-dose oral dexamethasone once daily on days 1-4, 9-12, and 17-20. Patients with minimal response or no response after 4 cycles of treatment could register for Step 2 treatment with thalidomide and high-dose dexamethasone. Thalidomide was given orally once daily on days 1-28, and dexamethasone once daily on days 1-4, 9-12, and 17-20 for 4 cycles.
563132|NCT00098371|B1|Baseline|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563133|NCT00098371|P1|Participant Flow|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.To improve tolerability of treatment regimen, an amendment to the protocol was done to reduce the cycle length from 42 days to 28 days, reducing the number of treatments per cycle from four (days 1, 8, 15 & 22) to three (days 1, 8, and 15).
563134|NCT00098371|O2|Outcome|Non-Responders|Patients who had stable disease (SD) or progressive disease (PD)
563135|NCT00098371|O1|Outcome|Responders|Patients who achieved a partial response (PR)
563136|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563137|NCT00098371|O6|Outcome|Patients Without Complex Karyotype|Complex Karyotype defined as fewer than three cytogenetic aberrations.
563138|NCT00098371|O5|Outcome|Patients With Complex Karyotype|Complex Karyotype defined as three or more cytogenetic aberrations.
563139|NCT00098371|O4|Outcome|Patients Without Del(11q22.3)|
563140|NCT00098371|O3|Outcome|Patients With Del(11q22.3)|
563141|NCT00098371|O2|Outcome|Patients Without Del(17p13.1)|
563142|NCT00098371|O1|Outcome|Patients With Del(17p13.1)|
563682|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563143|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
563144|NCT00098371|O2|Outcome|Group 2|Patients with dexamethasone
563145|NCT00098371|O1|Outcome|Group 1|Patients without dexamethasone
563146|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563147|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563148|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563149|NCT00098371|O1|Outcome|Treatment (Alvocidib)|"Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.~alvocidib"
563150|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563151|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563152|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563153|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563154|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563155|NCT00098371|O1|Outcome|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563156|NCT00098371|E1|Reported Event|Treatment (Alvocidib)|Patients receive flavopiridol IV over 30 minutes followed by a 4-hour infusion on days 1, 8, 15, and 22. Treatment repeats every 42 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients achieving at least a partial remission (PR) and whose PR lasts for > 6 months after completion of treatment may receive 6 additional courses of flavopiridol.
563157|NCT00098345|B1|Baseline|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563158|NCT00098345|P1|Participant Flow|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563159|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563160|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563161|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563162|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563163|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563164|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563165|NCT00098345|O1|Outcome|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563166|NCT00098345|E1|Reported Event|Caprelsa (Vandetanib) 300 mg|Daily oral dose of Caprelsa (vandetanib) 300mg
563167|NCT00098306|B4|Baseline|Total|Total of all reporting groups
563168|NCT00098306|B3|Baseline|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563169|NCT00098306|B2|Baseline|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563683|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563170|NCT00098306|B1|Baseline|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563171|NCT00098306|P7|Participant Flow|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563172|NCT00098306|P6|Participant Flow|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563173|NCT00098306|P5|Participant Flow|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
563174|NCT00098306|P4|Participant Flow|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563175|NCT00098306|P3|Participant Flow|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563176|NCT00098306|P2|Participant Flow|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563177|NCT00098306|P1|Participant Flow|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563178|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563179|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563180|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563181|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563182|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563183|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563184|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563185|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563186|NCT00098306|O1|Outcome|Maraviroc QD|Description Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563187|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563188|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563189|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563191|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563192|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563193|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563194|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563195|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563196|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563197|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563198|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563199|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563200|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563201|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563202|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563203|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563204|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563205|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563206|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563207|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563208|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563209|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563210|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563211|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563212|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563213|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563214|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563215|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563216|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563217|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563218|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563219|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563220|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563221|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563222|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563223|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563224|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563225|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563226|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563227|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563228|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563229|NCT00098306|O3|Outcome|Placebo|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563230|NCT00098306|O2|Outcome|Maraviroc BID|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563231|NCT00098306|O1|Outcome|Maraviroc QD|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563317|NCT00098254|E1|Reported Event|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563232|NCT00098306|E7|Reported Event|In Study-off Drug (ISOD), Observation Phase|Participants continuing from open label phase, who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563233|NCT00098306|E6|Reported Event|Maraviroc BID, Observation Phase|Participants continuing from open label phase, who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during observational phase.
563234|NCT00098306|E5|Reported Event|In Study-off Drug (ISOD), Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received no study treatment along with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) in during open label phase.
563235|NCT00098306|E4|Reported Event|Maraviroc BID, Open Label|Participants from maraviroc QD, maraviroc BID and Placebo (double blind phase) who received maraviroc 150 or 300 mg BID in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations) during open label phase.
563236|NCT00098306|E3|Reported Event|Placebo, Double Blind|Placebo matched to maraviroc tablet orally BID in the morning and evening, in combination with OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563237|NCT00098306|E2|Reported Event|Maraviroc BID, Double Blind|Maraviroc 150 or 300 mg tablet orally twice daily (BID) in the morning and evening, dose adjusted according to the other prescribed drugs taken by participants as part of OBT selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations).
563238|NCT00098306|E1|Reported Event|Maraviroc QD, Double Blind|Maraviroc 150 or 300 milligrams (mg) tablet orally once daily (QD) in the evening, dose adjusted according to the other prescribed drugs taken by participants as part of optimized background therapy (OBT) selected according to local standard of care (3 to 6 drugs based on resistance testing, treatment history and safety considerations). Placebo matched to maraviroc tablet orally in the morning.
563239|NCT00098293|B4|Baseline|Total|Total of all reporting groups
563240|NCT00098293|B3|Baseline|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, up to week 96 in DB phase. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily from Week 97 up to Week 240 in open-label (OL) phase.
563241|NCT00098293|B2|Baseline|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
563242|NCT00098293|B1|Baseline|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
563243|NCT00098293|P5|Participant Flow|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
563244|NCT00098293|P4|Participant Flow|Maraviroc Twice Daily + CBV (OL)|Participants who received maraviroc 300 mg tablet orally once daily treatment during the DB phase and who were eligible based on safety criteria and virologic response, switched to OL maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, following the DSMB recommendation to terminate the maraviroc once daily treatment arm after planned interim analysis. OL phase continued for at least 3 years after DB phase.
563245|NCT00098293|P3|Participant Flow|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
563246|NCT00098293|P2|Participant Flow|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
563369|NCT00098059|O2|Outcome|2 to <6 Years|
563370|NCT00098059|O1|Outcome|1 to < 2 Years|
563371|NCT00098059|O4|Outcome|13 to < =18 Years|
563247|NCT00098293|P1|Participant Flow|Maraviroc Once Daily + CBV (DB)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the double-blind (DB) phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. DB phase nominally ended at last participant’s Week 96 visit.
563248|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563249|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563250|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563251|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563252|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563253|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563254|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563255|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563256|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563257|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563258|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563259|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563260|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563261|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563262|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563372|NCT00098059|O3|Outcome|6 to <=12 Years|
563373|NCT00098059|O2|Outcome|2 to <6 Years|
563374|NCT00098059|O1|Outcome|1 to < 2 Years|
563375|NCT00098059|O4|Outcome|13 to <= 18 Years|
563263|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563264|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563265|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563266|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563267|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563268|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563269|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563270|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563271|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563272|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563273|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563274|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563275|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563276|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563277|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563278|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563376|NCT00098059|O3|Outcome|6 to <=12 Years|
563279|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563280|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563281|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563282|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563283|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563284|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563285|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563286|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563287|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563288|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563289|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563290|NCT00098293|O2|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563291|NCT00098293|O1|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563292|NCT00098293|O3|Outcome|Efavirenz Once Daily + CBV (DB)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563293|NCT00098293|O2|Outcome|Maraviroc Twice Daily + CBV (DB)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase.
563294|NCT00098293|O1|Outcome|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563377|NCT00098059|O2|Outcome|2 to <6 Years|
563295|NCT00098293|E4|Reported Event|Maraviroc Twice Daily + CBV (SP)|Participants who remained on mararviroc until their open-label phase End-of-Study visit and for whom maraviroc was commercially or otherwise unavailable entered an additional supplemental phase (SP) (initially planned for 6 months and subsequently extended for another 6 months) which consisted of study visits at 3-month intervals and received maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily until maraviroc was commercially or otherwise available.
563296|NCT00098293|E3|Reported Event|Efavirenz Once Daily + CBV (DB and OL)|Placebo matched to maraviroc 300 mg tablet orally twice daily and efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the OL phase. OL phase continued for at least 3 years after DB phase.
563297|NCT00098293|E2|Reported Event|Maraviroc Twice Daily + CBV (DB and OL)|Maraviroc 300 mg tablet orally twice daily and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase. DB phase nominally ended at last participant’s Week 96 visit. Maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the open-label (OL) phase. OL phase continued for at least 3 years after DB phase.
563298|NCT00098293|E1|Reported Event|Maraviroc Once Daily + CBV (DB), Then Twice Daily + CBV (OL)|Maraviroc 300 milligram (mg) tablet orally once daily in the evening along with placebo matched to maraviroc 300 mg tablet orally once daily in the morning and placebo matched to efavirenz 600 mg tablet orally once daily in the evening co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily, during the DB phase prior to the termination of the treatment arm based on the recommendation of the DSMB following a planned interim analysis. Eligible participants then switched to open-label maraviroc 300 mg tablet orally twice daily co-administered with combination therapy containing zidovudine 300 mg and lamivudine 150 mg (combivir [CBV]) tablet orally twice daily for the remainder of the study.
563299|NCT00098254|B1|Baseline|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563300|NCT00098254|P1|Participant Flow|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563301|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563302|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563303|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563304|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563305|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563306|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563307|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563308|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563309|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563310|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563311|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563312|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563313|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563314|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563315|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563316|NCT00098254|O1|Outcome|BAY 43-9006 (Sorafenib)|Self administered oral doses at 400 mg twice a day with 250 ml (8 oz.) of water each morning and evening (i.e., 12-hourly) continuously in a 28 day cycle. Tablets may be taken with or without food.
563318|NCT00097370|B1|Baseline|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563319|NCT00097370|P1|Participant Flow|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by intravenous (IV) infusion monthly in Stage 1 along with concomitant hypereosinophilic syndrome (HES)-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563320|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563321|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563322|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563323|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563324|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563325|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563326|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563327|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563328|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563329|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563330|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563331|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563332|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563378|NCT00098059|O1|Outcome|1 to < 2 Years|
563333|NCT00097370|O1|Outcome|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563334|NCT00097370|E1|Reported Event|Mepolizumab 750 mg|Participants received mepolizumab 750 mg by IV infusion monthly in Stage 1 along with concomitant HES-active medications that included prednisone (or equivalent) or other HES therapies. In Stage 2, the dosing intervals were optimized for each participant based on the individual’s blood eosinophil count and the clinical presentation. In Stage 3, the dosing frequency established in Stage 2 was continued with individual participant monitoring.
563335|NCT00097253|B1|Baseline|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563336|NCT00097253|P1|Participant Flow|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563337|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563338|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563339|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563340|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563341|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563342|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water control was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563343|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563344|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563345|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563346|NCT00097253|O3|Outcome|Lemon|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563347|NCT00097253|O2|Outcome|Water Control|A yellow-tinted cotton ball containing 100 μL of water was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563348|NCT00097253|O1|Outcome|Lavender|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563349|NCT00097253|E1|Reported Event|Lavender Oil / Lemon Oil / Water Control|A yellow-tinted cotton ball containing 100 μL of the essential oil or water placebo was taped between the nose and upper lip. Within-subject design was used; each subject was exposed to each of the three odors (lemon, lavender, no odor).
563350|NCT00098059|B3|Baseline|Total|Total of all reporting groups
563351|NCT00098059|B2|Baseline|Part B (Multiple-dose of Famciclovir)|Each patient in Part B received famciclovir twice a day (b.i.d.) approximately 12 hours apart for 7 days for a total of 14 doses. An 8-step dosing scheme (ranged from 150 mg b.i.d. to 500 mg b.i.d.) was used to determine the weight-based adjusted daily dose.
563352|NCT00098059|B1|Baseline|Part A (Single-dose of Famciclovir)|Each patient in Part A received a single dose of famciclovir (12.5 mg/kg).
563353|NCT00098059|P2|Participant Flow|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
563354|NCT00098059|P1|Participant Flow|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
563355|NCT00098059|O4|Outcome|13 to <=18 Years|
563356|NCT00098059|O3|Outcome|6 to <13 Years|
563357|NCT00098059|O2|Outcome|2 to <6 Years|
563358|NCT00098059|O1|Outcome|1 to < 2 Years|
563359|NCT00098059|O4|Outcome|13 to <= 18 Years|
563360|NCT00098059|O3|Outcome|6 to <=12 Years|
563361|NCT00098059|O2|Outcome|2 to <6 Years|
563362|NCT00098059|O1|Outcome|1 to < 2 Years|
563363|NCT00098059|O4|Outcome|13 to <= 18 Years|
563364|NCT00098059|O3|Outcome|6 to <=12 Years|
563365|NCT00098059|O2|Outcome|2 to <6 Years|
563366|NCT00098059|O1|Outcome|1 to < 2 Years|
563367|NCT00098059|O4|Outcome|13 to <= 18 Years|
563368|NCT00098059|O3|Outcome|6 to <=12 Years|
563395|NCT00098059|E2|Reported Event|Part B (Multiple-dose of Famciclovir)|Includes 47 patients enrolled in Part B. Part B started only after pharmacokinetic (PK) data from Part A had been analyzed. One patient that participated in Part A of the study also participated in Part B.
563396|NCT00098059|E1|Reported Event|Part A (Single-dose of Famciclovir)|Includes 27 patients enrolled in Part A. Two adolescent patients (13 to 18 years) were enrolled in Part A of this study under an amendment to the protocol to include adolescent aged patients. The amendment was rescinded in compliance with an FDA Pediatric Written Request and no further adolescent aged patients were enrolled.
563397|NCT00097981|B3|Baseline|Total|Total of all reporting groups
563398|NCT00097981|B2|Baseline|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563399|NCT00097981|B1|Baseline|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563400|NCT00097981|P2|Participant Flow|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563401|NCT00097981|P1|Participant Flow|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563402|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563403|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563404|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563405|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563406|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563407|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563408|NCT00097981|O2|Outcome|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563409|NCT00097981|O1|Outcome|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563410|NCT00097981|E2|Reported Event|DOXIL + Thalidomide + Dexamethasone|DOXIL 40 mg/m2 was administered intravenously on Day 1 and thalidomide every night (at bedtime) without food on Days 1-28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563411|NCT00097981|E1|Reported Event|Thalidomide + Dexamethasone|Participants received thalidomide every night (at bedtime) without food on Days 1 to 28 and dosing was gradually increased during Cycle 1 starting at 50 mg on Days 1 to 7, 100 mg on Days 8 to 14, 150 mg on 15 to 21, and 200 mg on Days 22 to 28. Thalidomide 200 mg per day was administered for subsequent cycles. Dexamethasone 40 mg was administered by mouth on Days 1 to 4, 9 to 12 and 17 to 20.
563412|NCT00097786|B5|Baseline|Total|Total of all reporting groups
563413|NCT00097786|B4|Baseline|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
563414|NCT00097786|B3|Baseline|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
563415|NCT00097786|B2|Baseline|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
563416|NCT00097786|B1|Baseline|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
563417|NCT00097786|P4|Participant Flow|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
563418|NCT00097786|P3|Participant Flow|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
563419|NCT00097786|P2|Participant Flow|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
563420|NCT00097786|P1|Participant Flow|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
563421|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
563422|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
563423|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
563424|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
563425|NCT00097786|O2|Outcome|Non-nateglinide|All patients from the treatment arms (1) valsartan 160 mg od and (2) placebo.
563426|NCT00097786|O1|Outcome|Nateglinide|All patients from the treatment arm (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) nateglinide 60 mg ac only.
563427|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
563428|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
563429|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
563430|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
563431|NCT00097786|O2|Outcome|Non-valsartan|All patients from the treatment arms (1) nateglinide 60 mg ac and (2) placebo.
563432|NCT00097786|O1|Outcome|Valsartan|All patients from the treatment arms (1) combined valsartan 160 mg od and nateglinide 60 mg ac and (2) valsartan 160 mg od only.
563433|NCT00097786|E4|Reported Event|Placebo|Patients took 3 placebo tablets identical to nateglinide tablets 3 times daily ac and 1 placebo capsule identical to valsartan capsule once daily in the morning.
563434|NCT00097786|E3|Reported Event|Nateglinide 60 mg ac + Placebo Valsartan|For the first 2 weeks of treatment, patients took one 30 mg tablet of nateglinide with a glass of water 1-30 minutes before each main meal of the day, ie, 3 times daily ante cibum (ac, before meals). If a meal was missed, the patient was not to take a tablet. After 2 weeks, patients were uptitrated to 60 mg nateglinide ac. Patients also received placebo matching valsartan capsules identical to the active valsartan capsules.
563435|NCT00097786|E2|Reported Event|Valsartan 160 mg od + Placebo Nateglinide|For the first 2 weeks of treatment, patients took valsartan 80 mg once daily (od) once in the morning. After 2 weeks, patients were uptitrated to 160 mg valsartan od. Patient also received placebo matching nateglinide tablets identical to the active nateglinide tablets (ac, before meals).
563436|NCT00097786|E1|Reported Event|Valsartan 160 mg od + Nateglinide 60 mg ac|For the first 2 weeks of treatment, patients took the combination of nateglinide 30 mg (3 times daily ante cibum [ac, before meals]) and valsartan 80 mg (once daily [od] in the morning). After 2 weeks, patients were uptitrated to nateglinide 60 mg ac and valsartan 160 mg od.
563437|NCT00097773|B5|Baseline|Total|Total of all reporting groups
563438|NCT00097773|B4|Baseline|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
563439|NCT00097773|B3|Baseline|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
563440|NCT00097773|B2|Baseline|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
563441|NCT00097773|B1|Baseline|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
563442|NCT00097773|P4|Participant Flow|Culture-Based TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
563501|NCT00097695|O2|Outcome|Randomized Control Trial-placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
563443|NCT00097773|P3|Participant Flow|Culture-Based TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (Pa)
563444|NCT00097773|P2|Participant Flow|Cycled TOBI and Oral Ciprofloxacin|Tobramycin solution for inhalation (TOBI) and oral ciprofloxacin for six consecutive quarterly cycles
563445|NCT00097773|P1|Participant Flow|Cycled TOBI and Oral Placebo|Tobramycin solution for inhalation (TOBI) and oral placebo for six consecutive quarterly cycles
563446|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
563447|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
563448|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
563449|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS therapy group
563450|NCT00097773|O4|Outcome|Oral Placebo|pooled oral placebo group
563451|NCT00097773|O3|Outcome|Oral Cipro|Pooled oral cipro group
563452|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS group
563453|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled TIS group
563454|NCT00097773|O4|Outcome|Oral Placebo|Pooled oral placebo group
563455|NCT00097773|O3|Outcome|Oral Ciprofloxacin|Pooled oral cipro group
563456|NCT00097773|O2|Outcome|Culture-Based TIS|Pooled Culture-Based TIS therapy group
563457|NCT00097773|O1|Outcome|Cycled TIS|Pooled Cycled tobramycin solution for inhalation (TIS) therapy group
563458|NCT00097773|E4|Reported Event|Culture-Based TIS w/Cipro|TOBI and oral ciprofloxacin administered only when quarterly respiratory cultures are found positive for PA
563459|NCT00097773|E3|Reported Event|Culture-Based TIS w/Placebo|TOBI and oral placebo administered only when quarterly respiratory cultures are found positive for Pseudomonas aeruginosa (PA)
563460|NCT00097773|E2|Reported Event|Cycled TIS w/Cipro|TOBI and oral ciprofloxacin for six consecutive quarterly cycles
563461|NCT00097773|E1|Reported Event|Cycled TIS w/Placebo|TOBI and oral placebo for six consecutive quarterly cycles
563462|NCT00097721|B3|Baseline|Total|Total of all reporting groups
563463|NCT00097721|B2|Baseline|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563464|NCT00097721|B1|Baseline|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563465|NCT00097721|P2|Participant Flow|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563466|NCT00097721|P1|Participant Flow|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563467|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563468|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563469|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563470|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563471|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563472|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563473|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563474|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563475|NCT00097721|O2|Outcome|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563476|NCT00097721|O1|Outcome|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563477|NCT00097721|E2|Reported Event|E7389 21 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1 and 8 of a 21 day cycle.
563478|NCT00097721|E1|Reported Event|E7389 28 Day Schedule|E7389 1.4 mg/m^2 intravenous bolus on Days 1, 8 and 15 of a 28 day cycle.
563479|NCT00097708|B4|Baseline|Total|Total of all reporting groups
563480|NCT00097708|B3|Baseline|Placebo|
563481|NCT00097708|B2|Baseline|IR Alprazolam|
563482|NCT00097708|B1|Baseline|OROS Alprazolam|
563483|NCT00097708|P3|Participant Flow|Placebo|OROS (osmotic [controlled] release oral [delivery] system) placebo administered orally once a day.
563484|NCT00097708|P2|Participant Flow|IR Alprazolam|IR (immediate release) alprazolam (Xanax) administered orally in divided dose (3 times daily), titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
563485|NCT00097708|P1|Participant Flow|OROS Alprazolam|OROS (osmotic [controlled] release oral [delivery] system) alprazolam administered orally once a day, titrated to maximum beneficial dose, 1,2,3,4,5, or 6 mg/day
563486|NCT00097708|O3|Outcome|Placebo|
563487|NCT00097708|O2|Outcome|IR Alprazolam|
563488|NCT00097708|O1|Outcome|OROS Alprazolam|
563489|NCT00097708|E3|Reported Event|Placebo|
563490|NCT00097708|E2|Reported Event|IR Alprazolam|
563491|NCT00097708|E1|Reported Event|OROS Alprazolam|
563492|NCT00097695|B5|Baseline|Total|Total of all reporting groups
563493|NCT00097695|B4|Baseline|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
563494|NCT00097695|B3|Baseline|Controlled Open-label / Laryngeal Attack|patients who received first treatment Open-Label due to laryngeal symptoms
563495|NCT00097695|B2|Baseline|Randomized -Placebo|Patients who were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
563496|NCT00097695|B1|Baseline|Randomized -Icatibant|Patients who were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
563497|NCT00097695|P4|Participant Flow|Untreated Patients at the Baseline|Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
563498|NCT00097695|P3|Participant Flow|Controlled Open-label / Laryngeal Attack|Patients with laryngeal symptoms at the baseline were not randomised but treated with icatibant open label during the controlled phase.
563502|NCT00097695|O1|Outcome|Randomized Control Trial-icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
563503|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
563504|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
563505|NCT00097695|O2|Outcome|Randomized -Placebo|29 Patients were randomized to placebo in the controlled phase after they had an eligible first in-study attack.
563506|NCT00097695|O1|Outcome|Randomized -Icatibant|27 Patients were randomized to icatibant in the controlled phase after they had an eligible first in-study attack.
563507|NCT00097695|E6|Reported Event|Open Label Extension Phase(Untreated Patients at the Baseline)|This represents adverse events experienced by Patients who were screened and found eligible but did not experience an angioedema attack, or had an attack that was not severe enough to merit treatment while the controlled phase was ongoing.
563508|NCT00097695|E5|Reported Event|Open Label Extension -Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the open label extension phase that were experienced by Patients with laryngeal symptoms at the baseline and got treated with open label icatibant during the controlled phase.
563509|NCT00097695|E4|Reported Event|Open Label Extension Phase- Icatibant (Previously Randomized)|Patients who were randomized to either icatibant or placebo in the controlled phase and experienced adverse events while participating in the open label extension phase.
563510|NCT00097695|E3|Reported Event|Controlled Phase- Icatibant (Subjects w/ Laryngeal Attack)|This represents adverse events during the controlled phase that were experienced by Patients with laryngeal symptoms at the baseline and were treated with open label icatibant during the controlled phase.
563511|NCT00097695|E2|Reported Event|Controlled Phase- Placebo (Randomized Subjects|Patients who were randomized to placebo in the controlled phase and experienced adverse events while participating in the controlled phase.
563512|NCT00097695|E1|Reported Event|Controlled Phase- Icatibant (Randomized Subjects )|Patients who were randomized to icatibant in the controlled and experienced adverse events while participating in the controlled phase.
563513|NCT00097591|B3|Baseline|Total|Total of all reporting groups
563514|NCT00097591|B2|Baseline|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563515|NCT00097591|B1|Baseline|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563516|NCT00097591|P2|Participant Flow|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563517|NCT00097591|P1|Participant Flow|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563518|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563519|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563520|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563521|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563522|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563523|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563524|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563525|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563526|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563527|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563528|NCT00097591|O2|Outcome|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563529|NCT00097591|O1|Outcome|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563530|NCT00097591|E2|Reported Event|Clopidogrel|Oral loading dose of four 75 mg clopidogrel tablets and six placebo tablets matched to prasugrel, followed by an oral maintenance dose of one 75 mg clopidogrel tablet and one placebo tablet matched to prasugrel once daily
563684|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563531|NCT00097591|E1|Reported Event|Prasugrel|Oral loading dose of six 10 mg prasugrel tablets and four placebo tablets matched to clopidogrel, followed by an oral maintenance dose of prasugrel one 10 mg tablet and one placebo tablet matched to clopidogrel once daily
563532|NCT00097539|B8|Baseline|Total|Total of all reporting groups
563533|NCT00097539|B7|Baseline|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563534|NCT00097539|B6|Baseline|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563535|NCT00097539|B5|Baseline|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563536|NCT00097539|B4|Baseline|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563537|NCT00097539|B3|Baseline|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563538|NCT00097539|B2|Baseline|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563539|NCT00097539|B1|Baseline|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563540|NCT00097539|P7|Participant Flow|Undefined Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563541|NCT00097539|P6|Participant Flow|Other Etiology|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. The other etiology group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563542|NCT00097539|P5|Participant Flow|Renal Disease|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Renal etiology group included participants with chronic renal insufficiency (CRI) or End Stage Renal Disease (ESRD) prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563543|NCT00097539|P4|Participant Flow|Turner Syndrome|Participants with Turner Syndrome who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563544|NCT00097539|P3|Participant Flow|Idiopathic Short Stature (ISS)|Participants with ISS who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Participants must have had a stimulation result of greater than or equal to (>/=) 10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563545|NCT00097539|P2|Participant Flow|Organic Growth Hormone Deficiency (GHD)|Participants who initiated therapy with GH products and who consented to participate in the NCGS were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. Organic GHD etiology group included participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, central nervous system (CNS) tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563565|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563566|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563546|NCT00097539|P1|Participant Flow|Idiopathic Growth Hormone Deficiency (IGHD)|Participants with IGDH who initiated therapy with Growth Hormone (GH) products (somatrem for injection [Protropin], somatropin for injection [Nutropin, Nutropin AQ, and Nutropin Depot]) and who consented to participate in the National Cooperative Growth Study (NCGS) were enrolled and observed. Participants received GH for the treatment of growth failure as determined by their physician. IGDH etiology group included participants with: Documented IGHD (a maximum GH stimulation test result of less than 10 nanograms per milliliter [ng/mL], coupled with a specific diagnosis of IGHD or equivalent condition by the attending physician; Undocumented IGHD (a stimulation test results were not available, but had a physician diagnosis specifically stated as IGHD or equivalent condition in text); or Presumed IGHD (a stimulation result of less than 10 ng/mL, coupled with the absence of any identifiable criterion for assignation to another etiology grouping).
563547|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563548|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563549|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563550|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563551|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563552|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563553|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563554|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563555|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563556|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563557|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563558|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563559|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563560|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563561|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563562|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563563|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563564|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563567|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563685|NCT00096785|E2|Reported Event|ETV 0.5 mg|
563568|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563569|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563570|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563571|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563572|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563573|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563574|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563575|NCT00097539|O7|Outcome|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563576|NCT00097539|O6|Outcome|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563577|NCT00097539|O5|Outcome|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563578|NCT00097539|O4|Outcome|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563579|NCT00097539|O3|Outcome|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563580|NCT00097539|O2|Outcome|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563581|NCT00097539|O1|Outcome|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563582|NCT00097539|E7|Reported Event|Undefined Etiology|A participants meeting none of the criteria above was classified as Undefined. These included participants with no medically relevant checkbox, no relevant medical text noted on the enrollment or follow-up forms, and no stimulation result available.
563583|NCT00097539|E6|Reported Event|Other Etiology|The other group represents a heterogeneous mix of participants. Classification in this grouping was determined by examination of enrollment form etiology and medical history checkboxes coupled with examination of participant medical text for selected conditions. Participants with a variety of congenital and/or genetic syndromes, such as Noonan syndrome or Prader-Willi syndrome, were largely included in this classification.
563584|NCT00097539|E5|Reported Event|Renal Disease|Participants with CRI or ESRD prior to transplantation as indicated by the CRI/ESRD checkbox on the current NCGS enrollment form or Chronic Renal Disease checkbox (RENAL) from older versions. A search for equivalent terminology in the medical text was also done.
563585|NCT00097539|E4|Reported Event|Turner Syndrome|Participants were assigned to this group, based on medical review of selected participants text, karyotype data, and medical history in cooperation with the NCGS medical advisor.
563586|NCT00097539|E3|Reported Event|Idiopathic Short Stature (ISS)|Participants must have had a stimulation result of >/=10 ng/mL and/or other identifiable relevant medical text related to ISS. Participants without any identifiable criterion for assignation elsewhere, coupled with a stimulation result of >/=10 ng/mL were assigned to this group. ISS participant may have been Documented ISS, Undocumented ISS, or Presumed ISS, based on text criteria and GH stimulation result of >/=10 ng/mL.
563587|NCT00097539|E2|Reported Event|Organic GHD|Participants with conditions that have a direct effect on the ability of the pituitary gland to modulate GH production, including craniopharyngioma, CNS tumors, CNS trauma, irradiation, septo-optic dysplasia, and effects of treatments given to participants with leukemia. Inclusion was determined by enrollment form etiology and medical history checkboxes coupled with examination of all participants text.
563588|NCT00097539|E1|Reported Event|Idiopathic Growth Hormone Deficiency (IGHD)|Participants who meet any one of the following definitions: Documented IGHD; Undocumented IGHD; Presumed IGHD.
563589|NCT00097500|B3|Baseline|Total|Total of all reporting groups
563591|NCT00097500|B1|Baseline|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563592|NCT00097500|P2|Participant Flow|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563593|NCT00097500|P1|Participant Flow|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563594|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563595|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563596|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563597|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563598|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563599|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563600|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563601|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563602|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563603|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563604|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563605|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563606|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563607|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563608|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563609|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563610|NCT00097500|O2|Outcome|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563611|NCT00097500|O1|Outcome|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563612|NCT00097500|E2|Reported Event|Insulin Glargine Arm|Dosing starts at 10 IU/day, and is then titrated, based on daily fasting blood glucose measurements.
563613|NCT00097500|E1|Reported Event|Exenatide Arm|5 mcg twice a day for 4 weeks, followed by 10 mcg twice a day for 8 weeks. After 12 weeks, exenatide is titrated (up to a maximum of 20 mcg three times a day) based on periodic glycosylated hemoglobin (HbA1c) measurements and tolerability.
563614|NCT00097448|B3|Baseline|Total|Total of all reporting groups
563615|NCT00097448|B2|Baseline|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
563616|NCT00097448|B1|Baseline|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
563617|NCT00097448|P2|Participant Flow|Intratympanic Steroids|1ml of methylprednisolone 10mg/ml. 4 doses over 14 days.
563618|NCT00097448|P1|Participant Flow|Oral Steroids|Prednisone 60mg per day x 14 days, 5 day taper.
563619|NCT00097448|O2|Outcome|IT Steroids|methylprednisolone
563620|NCT00097448|O1|Outcome|Oral Steroids|Prednisone
563621|NCT00097448|E2|Reported Event|IT Steroids|methylprednisolone
563622|NCT00097448|E1|Reported Event|Oral Steroids|Prednisone
563623|NCT00096993|B3|Baseline|Total|Total of all reporting groups
563624|NCT00096993|B2|Baseline|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563625|NCT00096993|B1|Baseline|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563686|NCT00096785|E1|Reported Event|ADV 10 mg|
563626|NCT00096993|P2|Participant Flow|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563627|NCT00096993|P1|Participant Flow|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563628|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563629|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563630|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563631|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563632|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563633|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563634|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563635|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563636|NCT00096993|O2|Outcome|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563637|NCT00096993|O1|Outcome|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563638|NCT00096993|E2|Reported Event|Pertuzumab + Gemcitabine|"Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Participants received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond. In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles~Gemcitabine: Gemcitabine was provided as a solution for infusion.~Pertuzumab: Pertuzumab was provided as a single-use formulation for infusion."
563639|NCT00096993|E1|Reported Event|Placebo + Gemcitabine|"Participants received placebo intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). In addition, participants received gemcitabine 800 mg/m^2 intravenously on Days 1 and 8 of every 3 week cycle for up to 1 year (up to 17 treatment cycles).~Placebo: Placebo was provided as a single-use formulation for infusion.~Gemcitabine: Gemcitabine was provided as a solution for infusion."
563640|NCT00096954|B3|Baseline|Total|Total of all reporting groups
563642|NCT00096954|B1|Baseline|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563643|NCT00096954|P2|Participant Flow|Placebo|The dose of placebo consisting of sucrose, L-histidine, L-histidine hydrochloride monohydrate, and polysorbate 20 was administered by subcutaneous injection every 2 or 4 weeks.
563644|NCT00096954|P1|Participant Flow|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563645|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563646|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563647|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563648|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563649|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563650|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563651|NCT00096954|O2|Outcome|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563652|NCT00096954|O1|Outcome|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563653|NCT00096954|E2|Reported Event|Placebo|The dose of placebo was administered by subcutaneous injection every 2 or 4 weeks.
563654|NCT00096954|E1|Reported Event|Omalizumab (Xolair)|Omalizumab (Xolair) was administered subcutaneously every 2 or 4 weeks. The dose (mg) and dosing frequency were determined by serum total IgE level (IU/mL), measured before the start of treatment, and body weight (kg). Assignment of the study drug dose was determined by using the study drug-dosing table. Doses of > 150 mg were divided among more than one injection site to limit injections to no more than 150 mg per site.
563655|NCT00096941|B1|Baseline|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
563656|NCT00096941|P1|Participant Flow|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
563657|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
563658|NCT00096941|O1|Outcome|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
563659|NCT00096941|E1|Reported Event|Pertuzumab|"Participants received the same dose of pertuzumab that they received in their parent Phase II trial, either 420 mg or 1050 mg, intravenously on Day 1 of every 3 week cycle until disease progression.~Pertuzumab: Pertuzumab was supplied as a single-use liquid formulation."
563660|NCT00096785|B3|Baseline|Total|Total of all reporting groups
563661|NCT00096785|B2|Baseline|Adefovir|ADV 10 mg QD
563662|NCT00096785|B1|Baseline|Entecavir|ETV 0.5 mg once daily (QD)
563663|NCT00096785|P2|Participant Flow|Adefovir|ADV 10 mg QD
563664|NCT00096785|P1|Participant Flow|Entecavir|ETV 0.5 mg once daily (QD)
563665|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563666|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563667|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563668|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563669|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563670|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563671|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563672|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563673|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563674|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563675|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563676|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563677|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563678|NCT00096785|O1|Outcome|Entecavir|ETV 0.5 mg once daily (QD)
563679|NCT00096785|O2|Outcome|Adefovir|ADV 10 mg QD
563687|NCT00096681|B1|Baseline|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
563688|NCT00096681|P1|Participant Flow|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
563689|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
563690|NCT00096681|O1|Outcome|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
563691|NCT00096681|E1|Reported Event|Participants From the Community|The number of participants from the community who attended the clinic for a once off study visit
563692|NCT00096538|B1|Baseline|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
563693|NCT00096538|P1|Participant Flow|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
563694|NCT00096538|O1|Outcome|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
563695|NCT00096538|E1|Reported Event|Valganciclovir|Patients receive oral valganciclovir twice daily for 3 weeks and then once daily for 21 weeks in the absence of disease progression or unacceptable toxicity. All patients are followed for 1 month after completion of therapy. Patients with responding disease are followed monthly for up to 1 year.
563696|NCT00096486|B5|Baseline|Total|Total of all reporting groups
563697|NCT00096486|B4|Baseline|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
563698|NCT00096486|B3|Baseline|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
563699|NCT00096486|B2|Baseline|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
563700|NCT00096486|B1|Baseline|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
563701|NCT00096486|P4|Participant Flow|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
563702|NCT00096486|P3|Participant Flow|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
563703|NCT00096486|P2|Participant Flow|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
563704|NCT00096486|P1|Participant Flow|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
563705|NCT00096486|O4|Outcome|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
563706|NCT00096486|O3|Outcome|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
563707|NCT00096486|O2|Outcome|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
563708|NCT00096486|O1|Outcome|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
563709|NCT00096486|E4|Reported Event|Phase II: Cohort II One or More Prior Chemotherapy|Phase II: Cohort II one or more prior chemotherapy
563710|NCT00096486|E3|Reported Event|Phase II: Cohort I no Prior Conventional Chemotherapy|Phase II: Cohort I no prior conventional chemotherapy
563711|NCT00096486|E2|Reported Event|Phase I: RAD001 5 mg, Gefitinib 250 mg|Phase I: RAD001 5 mg, Gefitinib 250 mg
563712|NCT00096486|E1|Reported Event|Phase I: RAD001 10 mg, Gefitinib 250 mg|Phase I: RAD001 10 mg, Gefitinib 250 mg
563713|NCT00096460|B3|Baseline|Total|Total of all reporting groups
563714|NCT00096460|B2|Baseline|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
563715|NCT00096460|B1|Baseline|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
563716|NCT00096460|P2|Participant Flow|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
563717|NCT00096460|P1|Participant Flow|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
563718|NCT00096460|O2|Outcome|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
563719|NCT00096460|O1|Outcome|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
563720|NCT00096460|E2|Reported Event|Allogeneic Hematopoietic Stem Cell Transplant (HSCT)|Human Leukocyte Antigen (HLA) matched sibling donor HSCT preceded by bone marrow ablation consisting of cyclophosphamide (750mg/m^2/day from day -6 to -4) fludarabine (30mg/m^2/day from day -6 to -4)
563721|NCT00096460|E1|Reported Event|Autologous Hematopoietic Stem Cell Transplant (HSCT)|Autologous HSCT preceded by bone marrow ablation including cyclophosphamide 100mg/kg, etoposide 60mg/kg and either radiation therapy at 1200cGy or carmustine at 15mg/kg
563722|NCT00096447|B1|Baseline|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563723|NCT00096447|P1|Participant Flow|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563724|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563725|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563726|NCT00096447|O1|Outcome|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563727|NCT00096447|E1|Reported Event|GW572016|1500 mg of GW572016 orally every day (cycle = 28 days) until disease progression or adverse effects prohibit further therapy
563728|NCT00096382|B3|Baseline|Total|Total of all reporting groups
563729|NCT00096382|B2|Baseline|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563730|NCT00096382|B1|Baseline|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563731|NCT00096382|P2|Participant Flow|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563732|NCT00096382|P1|Participant Flow|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563733|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563734|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563735|NCT00096382|O2|Outcome|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563736|NCT00096382|O1|Outcome|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563737|NCT00096382|E2|Reported Event|TBI 200cGy + TIL +HD IL-2, No Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563738|NCT00096382|E1|Reported Event|TBI 200cGy + TIL +HD IL-2, Prior IL-2|"Patients will receive 2Gy of total body irradiation (TBI) at a rate of 0.07 Gy/minute using a linear accelerator.~Lymphocytes that that are isolated from the tumor, grown in the laboratory to high amounts and then infused into the patient."
563739|NCT00096356|B3|Baseline|Total|Total of all reporting groups
563740|NCT00096356|B2|Baseline|Arm 2 - Placebo & Vitamin E|Placebo plus Vitamin E 100mg/day in 3 doses
563741|NCT00096356|B1|Baseline|Arm 1 - CoQ10 & Vitamin E|CoQ10 plus Vitamin E 100mg/day in 3 doses
563742|NCT00096356|P2|Participant Flow|Arm 2 - Placebo + Vitamin E|Placebo + Vitamin E 100mg/day in 3 doses
563743|NCT00096356|P1|Participant Flow|Arm 1 - CoQ10 + Vitamin E|CoQ10 + Vitamin E 100mg/day in 3 doses
563744|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
563745|NCT00096356|O1|Outcome|Arm 1- CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
563746|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
563747|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
563748|NCT00096356|O2|Outcome|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
563749|NCT00096356|O1|Outcome|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
563750|NCT00096356|E2|Reported Event|Arm 2 - Placebo & Vitamin E|Placebo-Vitamin E 100 mg/day in 3 doses
563751|NCT00096356|E1|Reported Event|Arm 1 - CoQ10 & Vitamin E|CoQ10 100mg capsule combined with Vitamin E 100 IU taken orally three times per day.
563752|NCT00096278|B3|Baseline|Total|Total of all reporting groups
563753|NCT00096278|B2|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
563754|NCT00096278|B1|Baseline|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
563755|NCT00096278|P2|Participant Flow|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
563756|NCT00096278|P1|Participant Flow|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
563757|NCT00096278|O2|Outcome|Arm 2: Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
563758|NCT00096278|O1|Outcome|Arm 1: Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
563759|NCT00096278|E2|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab|Oxaliplatin + Leucovorin + 5-Fluorouracil + Bevacizumab
563760|NCT00096278|E1|Reported Event|Oxaliplatin + Leucovorin + 5-Fluorouracil|Oxaliplatin + Leucovorin + 5-Fluorouracil
563761|NCT00096265|B4|Baseline|Total|Total of all reporting groups
563762|NCT00096265|B3|Baseline|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
563785|NCT00096200|O3|Outcome|Arm C: Crossover From Arm A to B|Cross-over arm: Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
565231|NCT00094575|O2|Outcome|Standard Open Repair|
563763|NCT00096265|B2|Baseline|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
563764|NCT00096265|B1|Baseline|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
563765|NCT00096265|P3|Participant Flow|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
563766|NCT00096265|P2|Participant Flow|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.
563767|NCT00096265|P1|Participant Flow|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
563768|NCT00096265|O3|Outcome|Erlotinib + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months.
563769|NCT00096265|O2|Outcome|Temozolomide + WBRT + SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
563770|NCT00096265|O1|Outcome|WBRT + SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery.
563771|NCT00096265|E3|Reported Event|Erlotinib+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral erlotinib once daily for up to 6 months. [Data is reported for eligible patients with adverse event information, which is 41 patients.]
563772|NCT00096265|E2|Reported Event|Temozolomide+WBRT+SRS|Patients undergo WBRT and stereotactic radiosurgery as in arm I. Beginning on the first day of WBRT, patients receive oral temozolomide once daily on days 1-21. Beginning 4 weeks after completion of WBRT, patients may receive oral temozolomide alone once daily on days 1-5. Treatment with temozolomide repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. [Data is reported for eligible patients with adverse event information, which is 39 patients.]
563773|NCT00096265|E1|Reported Event|WBRT+SRS|Patients undergo whole brain radiotherapy (WBRT) once daily on days 1-5, 8-12, and 15-19. Within 14 days after completion of WBRT, patients undergo stereotactic radiosurgery. [Data is reported for eligible patients with adverse event information, which is 44 patients.]
563774|NCT00096226|B1|Baseline|Chemoradiation, Surgery, Chemotherapy|"Chemoradiation, surgery, chemotherapy~carboplatin~paclitaxel~adjuvant therapy~conventional surgery~neoadjuvant therapy~radiation therapy"
563775|NCT00096226|P1|Participant Flow|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
563776|NCT00096226|O1|Outcome|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
563777|NCT00096226|E1|Reported Event|Chemoradiation, Surgery, Chemotherapy|Induction paclitaxel(50 mg/m2 I.V. in a one-hour infusion) and induction carboplatin (AUC 2.0 I.V. in a thirty-minute infusion): 1x/week for 6 weeks. Concurrent radiation therapy (RT): 1.8 Gy/day, 5 fx/week, for a total of 50.4 Gy in 28 fractions plus a boost of 1.8 Gy/day, 5 fx/week, for a total of 10.8 Gy in 6 fractions. Followed by an assessment to determine whether patient will undergo a resection or not. Followed by consolidation paclitaxel (200 mg/m2 I.V. over three hours) and consolidation carboplatin (AUC 6.0 over one hour) q 21 days x 2.
563778|NCT00096200|B4|Baseline|Total|Total of all reporting groups
563779|NCT00096200|B3|Baseline|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
563780|NCT00096200|B2|Baseline|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
563781|NCT00096200|B1|Baseline|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
563782|NCT00096200|P3|Participant Flow|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
563783|NCT00096200|P2|Participant Flow|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
563784|NCT00096200|P1|Participant Flow|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
563832|NCT00096018|E1|Reported Event|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563786|NCT00096200|O2|Outcome|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
563787|NCT00096200|O1|Outcome|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression after 2 cycles of treatment may crossover to arm B.
563788|NCT00096200|E3|Reported Event|Arm C|Patients from Arm A that had progressive disease were eligible to crossover to Arm B
563789|NCT00096200|E2|Reported Event|Arm B|Patients receive oral sorafenib twice daily on days 2-19. Patients also receive carboplatin IV over 30 minutes and paclitaxel IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
563790|NCT00096200|E1|Reported Event|Arm A|Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with disease progression crossover to arm II
563791|NCT00096174|B1|Baseline|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563792|NCT00096174|P1|Participant Flow|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563793|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563794|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563795|NCT00096174|O1|Outcome|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563796|NCT00096174|E1|Reported Event|Cisplatin, C225, Radiation|"Cetuximab therapy: Patients receive an initial loading dose of cetuximab intravenously (IV) over 2 hours on day 1. Patients then receive cetuximab IV over 1 hour on days 8, 15, 22, 29, 36, 43, 50, and 57.~Chemoradiotherapy: Beginning on day 15 of cetuximab therapy, patients undergo radiotherapy once daily, 5 days a week, for at least 7 weeks. Patients also receive cisplatin IV over 1-2 hours on days 15, 36, and 57.~Cetuximab maintenance therapy: After the completion of chemoradiotherapy, patients continue to receive cetuximab IV over 1 hour once weekly for 6-12 months."
563797|NCT00096135|B3|Baseline|Total|Total of all reporting groups
563798|NCT00096135|B2|Baseline|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563799|NCT00096135|B1|Baseline|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563800|NCT00096135|P2|Participant Flow|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563801|NCT00096135|P1|Participant Flow|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563833|NCT00095979|B1|Baseline|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563963|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563802|NCT00096135|O2|Outcome|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563803|NCT00096135|O1|Outcome|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563804|NCT00096135|E2|Reported Event|Testicular Relapse Patients (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, testicular radiation therapy, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563805|NCT00096135|E1|Reported Event|CNS Patients - Treatment (Combination Chemotherapy)|All patients receive common induction (vincristine sulfate, dexamethasone, daunorubicin hydrochloride & intrathecal triple therapy (ITT: methotrexate, therapeutic hydrocortisone and cytarabine)), consolidation (cytarabine, pegaspargase, filgrastim, re-induction (vincristine, dexamethasone, daunorubicin), and intensification chemotherapy (methotrexate, leucovorin calcium, mercaptopurine, etoposide, cyclophosphamide & ITT.
563806|NCT00096122|B1|Baseline|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
563807|NCT00096122|P1|Participant Flow|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
563808|NCT00096122|O1|Outcome|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
563809|NCT00096122|E1|Reported Event|Idarubicin, Cytarabine + Tipifarnib|Cytarabine 1.5 g/m^2 and Idarubicin 12 mg/m^2 intravenous (IV) continuously on days 1-3 (or 1-4), with Oral Tipifarnib 200/300 twice daily on days 1-21, repeats every 21 days.
563810|NCT00096109|B1|Baseline|Treatment (Tanespimycin)|Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
563811|NCT00096109|P1|Participant Flow|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
563812|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
563813|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
563814|NCT00096109|O1|Outcome|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Laboratory biomarker analysis: Correlative studies (was not completed due to the small number of samples)"
563815|NCT00096109|E1|Reported Event|Treatment (Tanespimycin)|"Patients receive tanespimycin IV over 1-6 hours on days 1, 4, 8, and 11. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~tanespimycin: Given IV~laboratory biomarker analysis: Correlative studies"
563816|NCT00096031|B1|Baseline|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
563817|NCT00096031|P1|Participant Flow|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
563818|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
563819|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
563820|NCT00096031|O1|Outcome|Cetuximab|250 mg/m^2 on days 1, 8, 15, and 22 of every 28-day cycle.
563821|NCT00096031|E1|Reported Event|Cetuximab|
563822|NCT00096018|B3|Baseline|Total|Total of all reporting groups
563823|NCT00096018|B2|Baseline|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563824|NCT00096018|B1|Baseline|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563825|NCT00096018|P2|Participant Flow|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563826|NCT00096018|P1|Participant Flow|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563827|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563828|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563829|NCT00096018|O2|Outcome|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563830|NCT00096018|O1|Outcome|Phase I - Dose Escalation|Thalidomide (100 mg/day, 200 mg/day, or 300 mg/day) on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563831|NCT00096018|E2|Reported Event|Phase II|Thalidomide 200 mg/day on Day 1 followed by Fludarabine 25 mg/m2/day for 5 days starting on Day 7 (cycle = 28 days)
563834|NCT00095979|P1|Participant Flow|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563835|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563836|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563837|NCT00095979|O1|Outcome|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563838|NCT00095979|E1|Reported Event|Ixabepilone|Ixabepilone 40 mg/m2 administered as 3-hour infusion on day 1 of a 21-day cycle until disease progression or adverse effects prohibit further treatment
563839|NCT00095940|B8|Baseline|Total|Total of all reporting groups
563840|NCT00095940|B7|Baseline|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563841|NCT00095940|B6|Baseline|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
563842|NCT00095940|B5|Baseline|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
563843|NCT00095940|B4|Baseline|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563844|NCT00095940|B3|Baseline|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563845|NCT00095940|B2|Baseline|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
563846|NCT00095940|B1|Baseline|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
563847|NCT00095940|P9|Participant Flow|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563848|NCT00095940|P8|Participant Flow|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
563849|NCT00095940|P7|Participant Flow|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
563850|NCT00095940|P6|Participant Flow|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563851|NCT00095940|P5|Participant Flow|High Grade Glioma: No Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
563852|NCT00095940|P4|Participant Flow|High Grade Glioma: Lapatinib Prior to Surgery|Participants with recurrent high grade glioma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
563853|NCT00095940|P3|Participant Flow|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment. These participants contributed to the phase II objectives.
563854|NCT00095940|P2|Participant Flow|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery. Participants who had measurable disease after surgery were eligible for the phase II objectives.
563855|NCT00095940|P1|Participant Flow|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery. These participants were not eligible for the phase II objectives.
563856|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
563857|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
563858|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
563859|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
563860|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
563861|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who provided formalin fixed paraffin embedded tumor material prior to treatment were included in the analysis population.
564493|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
563862|NCT00095940|O1|Outcome|Lapatinib: No Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment
563863|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
563864|NCT00095940|O3|Outcome|Recurrent Ependymoma|Participants with recurrent ependymoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
563865|NCT00095940|O2|Outcome|Recurrent High Grade Glioma|Participants with recurrent high grade glioma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
563866|NCT00095940|O1|Outcome|Recurrent Medulloblastoma|Participants with recurrent medulloblastoma who 1)were randomized to not receive lapatinib prior to surgery and had measureable disease after surgical resection or 2) did not have surgical resection of the tumor at study enrollment.
563867|NCT00095940|O2|Outcome|No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
563868|NCT00095940|O1|Outcome|Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma, high grade glioma, or ependymoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
563869|NCT00095940|E7|Reported Event|Ependymoma: No Surgery|Participants with recurrent ependymoma who did not have surgical resection of the tumor at study enrollment and were not eligible for the randomization to receive lapatinib or not prior to surgery.
563870|NCT00095940|E6|Reported Event|Ependymoma: No Lapatnib Prior to Surgery|Participants with recurrent ependymoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib 7-14 days prior to surgery.
563871|NCT00095940|E5|Reported Event|Ependymoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
563872|NCT00095940|E4|Reported Event|High Grade Glioma: No Surgery|Participants with recurrent high grade glioma who did not have surgical resection of the tumor at study enrollment.
563873|NCT00095940|E3|Reported Event|Medulloblastoma: No Surgery|Participants with recurrent medulloblastoma who did not have surgical resection of the tumor at study enrollment.
563874|NCT00095940|E2|Reported Event|Medulloblastoma: No Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to not receive lapatinib prior to surgery.
563875|NCT00095940|E1|Reported Event|Medulloblastoma: Lapatinib Prior to Surgery|Participants with recurrent medulloblastoma who had surgical resection of the tumor at study enrollment and were randomized to receive lapatinib 7-14 days prior to surgery.
563876|NCT00095875|B3|Baseline|Total|Total of all reporting groups
563877|NCT00095875|B2|Baseline|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
563878|NCT00095875|B1|Baseline|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
563879|NCT00095875|P2|Participant Flow|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
563880|NCT00095875|P1|Participant Flow|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
563881|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
563882|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
563917|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563883|NCT00095875|O2|Outcome|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
563884|NCT00095875|O1|Outcome|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
563885|NCT00095875|E2|Reported Event|Arm II|"Patients receive cisplatin IV on weeks 1 and 4 and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks"
563886|NCT00095875|E1|Reported Event|Arm I|"Patients receive induction chemotherapy comprising docetaxel, cisplatin, and fluorouracil. Treatment repeats every 21 days for 3 courses. Patients achieving a pathologic complete response at the primary site and a clinical complete response in the neck then receive carboplatin once weekly and undergo concurrent radiotherapy once daily, 5 days a week, for 7 weeks. Patients with a partial response at the primary site (i.e., positive biopsy), stable disease, or radiographic evidence of persistent disease in the neck receive docetaxel once weekly for 4 weeks and undergo concurrent radiotherapy once or twice daily, 5 days a week, for 6 weeks.~cisplatin : Given IV~radiation therapy : Patients undergo radiation therapy once or twice daily, 5 days a week, for up to 7 weeks~carboplatin : Given IV~fluorouracil : Given IV~docetaxel : Given IV"
563887|NCT00095784|B1|Baseline|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563888|NCT00095784|P1|Participant Flow|Decitabine|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563889|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563890|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563891|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563892|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563893|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563894|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563895|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563896|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563897|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563898|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563899|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563900|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563901|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563902|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563903|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563904|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563905|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563906|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563907|NCT00095784|O1|Outcome|Arm I|"Patients receive decitabine subcutaneously on days 1-5 and 8-12.~decitabine: Given SC"
563908|NCT00095784|O1|Outcome|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563909|NCT00095784|E1|Reported Event|Arm I|"Patients receive 0.3 mg/kg/day decitabine subcutaneously on days 1-5 and 8-12.~decitabine : Given SC"
563910|NCT00095576|B3|Baseline|Total|Total of all reporting groups
563911|NCT00095576|B2|Baseline|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563912|NCT00095576|B1|Baseline|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563913|NCT00095576|P2|Participant Flow|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563914|NCT00095576|P1|Participant Flow|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563915|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563916|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563918|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563919|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563920|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563921|NCT00095576|O2|Outcome|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563922|NCT00095576|O1|Outcome|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563923|NCT00095576|E2|Reported Event|Placebo|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of placebo to MRKAd5 HIV-1 gag/pol/nef at Day 1, Week 4, and Week 26.
563924|NCT00095576|E1|Reported Event|Trivalent MRKAd5 HIV-1 Gag/Pol/Nef|Participants randomized to receive three 1.0-ml intramuscular (IM) injections of Merck Trivalent Adenovirus Serotype 5 HIV-1 gag/pol/nef (MRKAd5 HIV-1 gag/pol/nef) Vaccine at a dose of 1.5x10^10 adenovirus genomes (Ad vg) per dose at Day 1, Week 4, and Week 26.
563925|NCT00095498|B4|Baseline|Total|Total of all reporting groups
563926|NCT00095498|B3|Baseline|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563927|NCT00095498|B2|Baseline|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563928|NCT00095498|B1|Baseline|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563929|NCT00095498|P3|Participant Flow|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563930|NCT00095498|P2|Participant Flow|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563931|NCT00095498|P1|Participant Flow|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563932|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563933|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563934|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563935|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563936|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563937|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563938|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563939|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563940|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563941|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563942|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563943|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563944|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563945|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563946|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563947|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563948|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563949|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563950|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563951|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563952|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563953|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563954|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563955|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563956|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563957|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563958|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563959|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563960|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563961|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563962|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563964|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563965|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563966|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563967|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563968|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563969|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563970|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563971|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563972|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563973|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563974|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563975|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563976|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563977|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563978|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563979|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563980|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563981|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563982|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563983|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563984|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563985|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563986|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563987|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563988|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563989|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563990|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563991|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563992|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563993|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563994|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563995|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563996|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563997|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
563998|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
563999|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564000|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564001|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564002|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564003|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564004|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564005|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564006|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564007|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564008|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564009|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564010|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564011|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564012|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564013|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564014|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564015|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564016|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564017|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564018|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564019|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564020|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564021|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564022|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564023|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564024|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564025|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564026|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564027|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564028|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564029|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564030|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564031|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564032|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564033|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564034|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564035|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564036|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564037|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564038|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564039|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564040|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564041|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564042|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564043|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564044|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564045|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564046|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564047|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564048|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564049|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564050|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564051|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564052|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564053|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564054|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564055|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564056|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564057|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564058|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564059|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564060|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564061|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564062|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564063|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564064|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564065|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564066|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564067|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564068|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564069|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564070|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564071|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564072|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564073|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564074|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564075|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564076|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564077|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564078|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564079|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564080|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564081|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564082|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564083|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564084|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564085|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564086|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564087|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564088|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564089|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564090|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564091|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564092|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564093|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564094|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564095|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564096|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564097|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564098|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564099|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564100|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564101|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564102|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564103|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564104|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564105|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564106|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564107|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564108|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564109|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564110|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564111|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564112|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564113|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564114|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564115|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564116|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564117|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564118|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564119|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564120|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564121|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564122|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564123|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564124|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564125|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564126|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564127|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564128|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564129|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564130|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564131|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564132|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564133|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564134|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564135|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564136|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564137|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564138|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564139|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564140|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564141|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564142|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564143|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564144|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564145|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564146|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564147|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564148|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564149|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564150|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564151|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564152|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564153|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564154|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564155|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564156|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564157|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564158|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564159|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564160|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564161|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564162|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564163|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564164|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564165|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564166|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564167|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564168|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564169|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564170|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564171|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564172|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564173|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564174|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564175|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564176|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564177|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564178|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564179|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564180|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564181|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564182|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564183|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564184|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564185|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564186|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564187|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564188|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564189|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564190|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564191|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564192|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564193|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564194|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564195|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564196|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564197|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564198|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564199|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564200|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564201|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564202|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564203|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564204|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564205|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564206|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564207|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564208|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564209|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564210|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564211|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564212|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564213|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564214|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564215|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564216|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564217|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564218|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564219|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564220|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564221|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564222|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564223|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564224|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564225|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564226|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564227|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564228|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564229|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564230|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564231|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564232|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564233|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564234|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564235|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564236|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564237|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564238|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564239|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564240|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564241|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564242|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564243|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564244|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564245|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564246|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564247|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564248|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564249|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564250|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564251|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564252|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564253|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564254|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564255|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564256|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564257|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564258|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564259|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564260|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564261|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564262|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564263|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564264|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564265|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564266|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564267|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564268|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564269|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564270|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564271|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564272|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564273|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564274|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564275|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564276|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564277|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564278|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564279|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564280|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564281|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564282|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564283|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564284|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564285|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564286|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564287|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564288|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564289|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564290|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564291|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564292|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564293|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564294|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564295|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564296|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564297|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564298|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564299|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564300|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564301|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564302|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564303|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564304|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564305|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564306|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564307|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564308|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564309|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564310|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564311|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564312|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564313|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564314|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564315|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564316|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564317|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564318|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564319|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564320|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564321|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564322|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564323|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564324|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564325|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564326|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564327|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564328|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564329|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564330|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564331|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564332|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564333|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564334|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564335|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564336|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564337|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564338|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564339|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564340|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564341|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564342|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564343|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564344|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564345|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564346|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564347|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564348|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564349|NCT00095498|O3|Outcome|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564350|NCT00095498|O2|Outcome|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564351|NCT00095498|O1|Outcome|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564352|NCT00095498|E3|Reported Event|Denosumab 180 mg|Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564353|NCT00095498|E2|Reported Event|Denosumab 60 mg|Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6.
564354|NCT00095498|E1|Reported Event|Placebo|Participants received placebo subcutaneous injections on Day 1 and at Month 6.
564355|NCT00095303|B3|Baseline|Total|Total of all reporting groups
564356|NCT00095303|B2|Baseline|TAU- Treatment as Usual|TAU: Treatment As Usual. Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT Typically services include individual, group, and family therapy sessions as well as case management
564357|NCT00095303|B1|Baseline|BSFT|BSFT: Brief Strategic Family Therapy. 12-16 sessions, ranging from 8 to 24 as full dose Sessions include adolescents and family members
564358|NCT00095303|P2|Participant Flow|Treatment as Usual|Treatment as Usual : TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
564359|NCT00095303|P1|Participant Flow|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers : BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
564360|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564361|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564362|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564363|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564364|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564365|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564366|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564367|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564368|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564369|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564370|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564371|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564372|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564373|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564374|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564375|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564376|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564377|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564378|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564379|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564380|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564381|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564382|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564383|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564384|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564385|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564386|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564387|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564388|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564389|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564390|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564391|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564392|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564393|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564394|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564395|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564396|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564397|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564398|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564399|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564400|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564401|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564402|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564403|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564404|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564405|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564406|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564407|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564408|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564409|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564410|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564411|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564412|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564413|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564414|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564415|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564416|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564417|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564418|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564419|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564420|NCT00095303|O2|Outcome|TAU- Treatment as Usual|"TAU: Treat As Usual~Agencies required to have a standard treatment as usual that minimally met the same expectations at BSFT~Typically services include individual, group, and family therapy sessions as well as case management"
564421|NCT00095303|O1|Outcome|BSFT|"BSFT:~12-16 sessions, ranging from 8 to 24 as full dose~Sessions include adolescents and family members"
564422|NCT00095303|E2|Reported Event|Treatment as Usual|Treatment as Usual: TAU varies depending on site, however each will offer services that include at least 1 therapy session per week (individual or group therapy) as well as participation in ancillary services (e.g., case management, self help groups, etc.) over a four month period.
564423|NCT00095303|E1|Reported Event|BSFT|"Brief Strategic Family Therapy For Adolescent Drug Abusers: BSFT is a family therapy approach that consists of 12 to 16 sessions (each 1 to 1.5 hours long) over a 4-month period, and up to 8 booster sessions. Interventions are delivered to adolescents and relevant family members in non-restrictive community settings (e.g., clinics, homes, school)."
564424|NCT00095238|B3|Baseline|Total|Total of all reporting groups
564425|NCT00095238|B2|Baseline|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564426|NCT00095238|B1|Baseline|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564427|NCT00095238|P2|Participant Flow|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564428|NCT00095238|P1|Participant Flow|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564429|NCT00095238|O4|Outcome|Placebo no ACE-I Use|
564430|NCT00095238|O3|Outcome|Irbesartan no ACE-I Use|
564431|NCT00095238|O2|Outcome|Placebo + ACE-I Use|
564432|NCT00095238|O1|Outcome|Irbesartan + ACE-I Use|
564433|NCT00095238|O6|Outcome|Irbesartan - Month 66|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 66
564434|NCT00095238|O5|Outcome|Placebo - Month 66|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 66
564435|NCT00095238|O4|Outcome|Irbesartan - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
564436|NCT00095238|O3|Outcome|Placebo - Month 54|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 54
564437|NCT00095238|O2|Outcome|Irbesartan - Month 42|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 42
565232|NCT00094575|O1|Outcome|Endovascular Repair|
564438|NCT00095238|O1|Outcome|Placebo - Month 42|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 42
564439|NCT00095238|O6|Outcome|Irbesartan - Month 30|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 30
564440|NCT00095238|O5|Outcome|Placebo - Month 30|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 30
564441|NCT00095238|O4|Outcome|Irbesartan - Month 18|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 18
564442|NCT00095238|O3|Outcome|Placebo - Month 18|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 18
564443|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in irbesartan group with GFR assessment at Baseline and Month 6
564444|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with GFR assessment at Baseline and Month 6
564445|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564446|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564447|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564448|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564449|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564450|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564451|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564452|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564453|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564454|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564455|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564456|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564457|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564458|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564459|NCT00095238|O6|Outcome|Placebo Baseline All Classes Combined|
564460|NCT00095238|O5|Outcome|Placebo Class III or IV|
564461|NCT00095238|O4|Outcome|Placebo Baseline Class I or II|
564462|NCT00095238|O3|Outcome|Irbesartan Baseline All Classes Combined|
564463|NCT00095238|O2|Outcome|Irbesartan Class III or IV|Class III (Moderate): Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe): Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased.
564464|NCT00095238|O1|Outcome|Irbesartan Baseline Class I or II|Class I (Mild): No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild): Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea.
564465|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564466|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564467|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564468|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564469|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564470|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564471|NCT00095238|O4|Outcome|Irbesartan - Month 14|Irbesartan cohort with measurements at Baseline and Month 14.
564472|NCT00095238|O3|Outcome|Placebo - Month 14|Placebo cohort with measurements at Baseline and Month 14.
564473|NCT00095238|O2|Outcome|Irbesartan - Month 6|Irbesartan cohort with measurements at Baseline and Month 6.
564474|NCT00095238|O1|Outcome|Placebo - Month 6|Placebo cohort with measurements at baseline and Month 6.
564475|NCT00095238|O2|Outcome|Irbesartan - Final Visit|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Final Visit
564476|NCT00095238|O1|Outcome|Placebo - Final Visit|Cohort of participants in Placebo group with MLwHF scores at Baseline and Final Visit
564477|NCT00095238|O4|Outcome|Irbesartan - Month 14|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 14
564478|NCT00095238|O3|Outcome|Placebo - Month 14|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 14
564479|NCT00095238|O2|Outcome|Irbesartan - Month 6|Cohort of participants in Irbesartan group with MLwHF scores at Baseline and Month 6
564480|NCT00095238|O1|Outcome|Placebo - Month 6|Cohort of participants in Placebo group with MLwHF scores at Baseline and Month 6
564481|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564482|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564483|NCT00095238|O2|Outcome|Placebo|titration from 75 to 300 mg, once daily (QD), up to 6 years
564484|NCT00095238|O1|Outcome|Irbesartan|titration from 75 to 300 mg, once daily (QD), up to 6 years
564485|NCT00095238|E2|Reported Event|PLACEBO|titration from 75 to 300 mg, once daily (QD), up to 6 years
564486|NCT00095238|E1|Reported Event|IRBESARTAN|titration from 75 to 300 mg, once daily (QD), up to 6 years
564487|NCT00095212|B3|Baseline|Total|Total of all reporting groups
564488|NCT00095212|B2|Baseline|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564489|NCT00095212|B1|Baseline|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564490|NCT00095212|P2|Participant Flow|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564491|NCT00095212|P1|Participant Flow|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564492|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564494|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564495|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564496|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564497|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564498|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564499|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564500|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564501|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564502|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564503|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564504|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564505|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564506|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564507|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564508|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564509|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564510|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564511|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564512|NCT00095212|O2|Outcome|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564513|NCT00095212|O1|Outcome|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564514|NCT00095212|E2|Reported Event|Placebo Patch (Identical in Appearance)|placebo patch (0 micrograms of testosterone)applied twice a week
564515|NCT00095212|E1|Reported Event|Transdermal Testosterone (Patch)|300 micrograms applied twice a week
564516|NCT00095199|B5|Baseline|Total|Total of all reporting groups
564517|NCT00095199|B4|Baseline|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564518|NCT00095199|B3|Baseline|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564519|NCT00095199|B2|Baseline|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564520|NCT00095199|B1|Baseline|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564521|NCT00095199|P4|Participant Flow|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564522|NCT00095199|P3|Participant Flow|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564523|NCT00095199|P2|Participant Flow|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
564524|NCT00095199|P1|Participant Flow|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564525|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564526|NCT00095199|O3|Outcome|Cetuximab + Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Day 1 of every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
564527|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564528|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week cycles) until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564529|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564530|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week cycles).
564531|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564532|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
564533|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564534|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week cycles), after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564535|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564536|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564537|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564538|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564539|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564540|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564541|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564542|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564543|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564544|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
564545|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564546|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564547|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564548|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564549|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564550|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564551|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564552|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564553|NCT00095199|O4|Outcome|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564554|NCT00095199|O3|Outcome|Cetuximab & Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously every 3 weeks cycle for up to six (3-week) cycles, after 6 cycles participants on the chemotherapy/cetuximab combination may continue cetuximab alone. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564555|NCT00095199|O2|Outcome|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564556|NCT00095199|O1|Outcome|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week cycles).
564557|NCT00095199|E4|Reported Event|Docetaxel|Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
564558|NCT00095199|E3|Reported Event|Cetuximab and Docetaxel|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles until disease progression or unacceptable toxicity. Docetaxel 75 mg/m^2 administered intravenously on Day 1 of 3 weeks cycle for up to six (3-week) cycles.
564559|NCT00095199|E2|Reported Event|Pemetrexed|Pemetrexed 500 mg/m^2 administered intravenously on Day 1 of 3 week cycle for up to six (3-week) cycles.
564560|NCT00095199|E1|Reported Event|Cetuximab & Pemetrexed|Cetuximab 400/250 mg/m^2 (initial/weekly) administered intravenously on Days 1, 8, and 15 (3-week) cycles, until disease progression or unacceptable toxicity. Pemetrexed 500 mg/m^2 administered intravenously on day 1 of 3 weeks cycle until disease progression or unacceptable toxicity for up to six (3-week) cycles.
565086|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
564561|NCT00095173|B1|Baseline|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes,once every 2 weeks for 3 doses, then monthly up to 6 months unless a disease flare discontinued the patient earlier.
564562|NCT00095173|P6|Participant Flow|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564563|NCT00095173|P5|Participant Flow|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564564|NCT00095173|P4|Participant Flow|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) or once a month for up to 5 years (Period C).
564565|NCT00095173|P3|Participant Flow|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564566|NCT00095173|P2|Participant Flow|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare (Period B).
564567|NCT00095173|P1|Participant Flow|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
564568|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564569|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564570|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
564571|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564572|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564573|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564574|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses.
564575|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564576|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564577|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
564578|NCT00095173|O1|Outcome|Abatacept (All Participants in Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564579|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564580|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564581|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
564582|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564583|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564608|NCT00095147|P2|Participant Flow|Infliximab (INF) + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564584|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
564585|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564586|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564587|NCT00095173|O3|Outcome|Placebo (Period B) to Abatacept (Period C)|Participants from Period B Placebo group entering Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564588|NCT00095173|O2|Outcome|Abatacept (Period C)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years.
564589|NCT00095173|O1|Outcome|Abatacept (Period A Non-Responders in Period C)|Participants not eligible to continue into Period B but re-entered in Period C. Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C).
564590|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564591|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564592|NCT00095173|O1|Outcome|Abatacept (All Participants in Period A)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses.
564593|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564594|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564595|NCT00095173|O2|Outcome|Placebo (Period B)|Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion.
564596|NCT00095173|O1|Outcome|Abatacept (Period B)|Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for 6 months or until they experienced a flare.
564597|NCT00095173|E4|Reported Event|Abatacept (Period A)/Placebo (Period B)|"All participants treated with Abatacept in Period A, placebo in Period B, who may or may not have entered Period C.~Placebo: Dextrose 5% in water (D5W) or normal saline (NS) IV infusion, once every 2 weeks for 3 doses, then monthly up to 6 months. Participants were seated or in supine position during infusion. If participants entered Period C, they were treated with Abatacept,10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once a month for up to 5 years."
564598|NCT00095173|E3|Reported Event|Abatacept (Period A/Period B)|"All participants treated with Abatacept in Periods A and B who may or may not have entered Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses, then once a month for 6 months. If participants entered Period C, treatment continued once a month for up to 5 years."
564599|NCT00095173|E2|Reported Event|Abatacept (Period A/Period C)|"Participants treated in Period A, not eligible to continue into Period B, but re-entered in Period C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every two weeks for three doses (Period A) and once a month for up to 5 years (Period C)."
564600|NCT00095173|E1|Reported Event|Abatacept (Only Period A)|"Participants treated in Period A but did not in Periods B or C.~Abatacept: 10 milligram per kilogram body weight (mg/kg), limited to a maximum 1000 mg for participants weighing >100kg; solution infused intravenously (IV), over 90 minutes, once every 2 weeks for 3 doses."
564601|NCT00095147|B4|Baseline|Total|Total of all reporting groups
564602|NCT00095147|B3|Baseline|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564603|NCT00095147|B2|Baseline|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564604|NCT00095147|B1|Baseline|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564605|NCT00095147|P5|Participant Flow|ABA + MTX [Open-label (OL)]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564606|NCT00095147|P4|Participant Flow|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564607|NCT00095147|P3|Participant Flow|Placebo (PLA) + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
565233|NCT00094575|O2|Outcome|Standard Open Repair|
564609|NCT00095147|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) [Double-blind (DB)]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564610|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564611|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564612|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564613|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564614|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564615|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564616|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564617|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564618|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564619|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564620|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564621|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564622|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564623|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564624|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564625|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564626|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564627|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564628|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564629|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564630|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564631|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564632|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564633|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564634|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564635|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564636|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564637|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564638|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564639|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564640|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564641|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564642|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564643|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564644|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564645|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564646|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564647|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564648|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564649|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564650|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564651|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564652|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564653|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564654|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564655|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564656|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564657|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564658|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564659|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564660|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564661|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564662|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564663|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564664|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564665|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564666|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564667|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564668|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564669|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564670|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564671|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564672|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564673|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564674|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564675|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564676|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564677|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564678|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564679|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564680|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564681|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564682|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564683|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564684|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564685|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564686|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564687|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564688|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564689|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564690|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564691|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
565234|NCT00094575|O1|Outcome|Endovascular Repair|
564692|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564693|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564694|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564695|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564696|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants <60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants >100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564697|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564698|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564699|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564700|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564701|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564702|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564703|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564704|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564705|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564706|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564707|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564708|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564709|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564710|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564711|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564712|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564713|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564714|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564715|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564716|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564717|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564718|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564719|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564720|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564721|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564722|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564723|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564724|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564725|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564726|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564727|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564728|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564729|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564730|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564731|NCT00095147|O2|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564732|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564733|NCT00095147|O3|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564734|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564735|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564736|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564737|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564738|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564739|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564740|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564741|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564742|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564743|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564744|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564745|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564746|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564747|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564748|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564749|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564750|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564751|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564752|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564753|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564754|NCT00095147|O1|Outcome|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564755|NCT00095147|O1|Outcome|PLA Switched to ABA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564756|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564757|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564758|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564759|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564760|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564761|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564762|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564763|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564764|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564765|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564766|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564767|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564768|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564769|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564770|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564771|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564772|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564799|NCT00095147|E2|Reported Event|ABA + MTX [OL]|All participants received ABA at a weight-tiered dose of 10 mg/kg plus a stable dose of MTX (minimum 15 mg weekly).
564773|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564774|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564775|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564776|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564777|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564778|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564779|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564780|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564781|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564782|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564783|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564784|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564785|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564786|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564787|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564788|NCT00095147|O3|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564789|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564790|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564791|NCT00095147|O2|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564792|NCT00095147|O1|Outcome|ABA + MTX [DB[|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564793|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564794|NCT00095147|O1|Outcome|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly)
564795|NCT00095147|O2|Outcome|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly)
564796|NCT00095147|O1|Outcome|ABA + MTX [DB]|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564797|NCT00095147|E4|Reported Event|PLA + MTX [DB]|Normal saline was administered as placebo. All participants received a stable dose of MTX (minimum 15 mg weekly). After placebo treatment from Day 1-197, 104 participants were reallocated to receive abatacept (weight based) plus a stable dose of MTX (minimum 15 mg weekly).
564798|NCT00095147|E3|Reported Event|INF + MTX [DB]|Infliximab was given 3 mg/kg IV (approved labeled dose) on Days 1, 15, 43, 85 and every 56 days thereafter for a total of 8 doses. All participants received a stable dose of MTX (minimum 15 mg weekly).
564800|NCT00095147|E1|Reported Event|ABA (DB)|Abatacept was administered intravenously (IV) on Days 1, 15, 29 and every 28 days thereafter for a total of 14 doses. Administration was as follows: 500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 gram for participants > 100 kg. All participants received a stable dose of MTX (minimum 15 mg weekly).
564801|NCT00095121|B3|Baseline|Total|Total of all reporting groups
564802|NCT00095121|B2|Baseline|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564803|NCT00095121|B1|Baseline|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564804|NCT00095121|P2|Participant Flow|PLB - ADV|Placebo (PLB) was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of open-label (OL) ADV treatment (ADV Week 192). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
564805|NCT00095121|P1|Participant Flow|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The adefovir dipivoxil (ADV) baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind [DB] ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Lamivudine was to be added to the open-label ADV regimen of subjects between 12 and <18 years old who had prior lamivudine exposure and who had a serum HBV DNA concentration >= 1000 copies/mL at 2 consecutive study visits at or after Study Week 96.
564806|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564807|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564808|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564809|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564810|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564811|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564848|NCT00095056|B3|Baseline|Total|Total of all reporting groups
564899|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564812|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564813|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564814|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564815|NCT00095121|O2|Outcome|Placebo (PBL)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the double-blind treatment period. RAT included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
564816|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment during the double-blind treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Randomized and Treated Analysis Set (RAT) included adverse events that occurred up to the last dose of double-blind treatment + 4 days or if discontinued early, 30 days after last double-blind dose.
564817|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564818|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564819|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564820|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564821|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564822|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564894|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564895|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564823|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564824|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564825|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564826|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564827|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564828|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564829|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564830|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or HBsAg seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 to 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564831|NCT00095121|O1|Outcome|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 to 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564832|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564833|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564896|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564834|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564835|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564836|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564837|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to double-blind ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564838|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564839|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564840|NCT00095121|O2|Outcome|PLB - ADV|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group. The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192).
564841|NCT00095121|O1|Outcome|ADV - ADV|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. The ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). Additionally, ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240).
564842|NCT00095121|O2|Outcome|Placebo (PLB)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group.
564843|NCT00095121|O1|Outcome|Adefovir Dipivoxil (ADV)|Once daily treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet.
564844|NCT00095121|E4|Reported Event|PLB - ADV|Placebo was matched to ADV treatment (oral suspension or tablet) by age group for the DB treatment period. At Week 48, all placebo-treated participants who did not exhibit HBeAg or hepatitis B surface antigen seroconversion at Week 44 were offered the opportunity to receive OL ADV for up to an additional 192 weeks (ie, enter the OL study period; Weeks 49 - 240).The ADV baseline was defined as the day of first dose of ADV (ie, Week 48 for those originally randomized to placebo [PLB-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the PLB-ADV group could receive only up to 192 weeks of ADV treatment (ADV Week 192). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
564845|NCT00095121|E3|Reported Event|ADV - ADV|Double-blind once daily ADV treatment: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. At Week 48, ADV−treated participants were offered the opportunity to receive open-label ADV for up to an additional 192 weeks (ie, OL Weeks 49 - 240). ADV baseline was defined as the day of first dose of ADV (ie, Week 0 for participants originally randomized to DB ADV [ADV-ADV group]). ADV week was defined as the windowed visit week relative to ADV baseline. Thus, participants in the ADV-ADV group could have received up to 240 weeks of ADV treatment (ADV Week 240). Treatment-emergent AEs for the OL period are events that began on or after the date of the first dose of OL ADV, and include only new events (ie, events that were never observed during the DB period, or, events observed during the DB period but with greater severity during the OL period).
564846|NCT00095121|E2|Reported Event|PLB (Double-Blind)|Placebo was matched to adefovir dipivoxil treatment (oral suspension or tablet) by age group for the DB treatment period. Treatment-emergent AEs for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
564847|NCT00095121|E1|Reported Event|ADV (Double-Blind)|Once daily treatment during the DB treatment period: children aged 2 to <7 years received 0.3 mg/kg oral suspension; children aged >=7 to <12 years received 0.25 mg/kg oral suspension; children aged >=12 to <18 years received 10 mg tablet. Treatment-emergent adverse events (AEs) for the DB period are events that occurred up to the last dose of DB treatment + 4 days or if discontinued early, 30 days after last DB dose.
564849|NCT00095056|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564850|NCT00095056|B1|Baseline|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564851|NCT00095056|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564852|NCT00095056|P1|Participant Flow|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564853|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564854|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564855|NCT00095056|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564856|NCT00095056|O1|Outcome|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564857|NCT00095056|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with either one (1) tablet of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl <30 mL/min or dialysis] or two (2) tablets of placebo matching sitagliptin 25 mg (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Placebo group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564897|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564898|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
565083|NCT00094809|P2|Participant Flow|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
564858|NCT00095056|E1|Reported Event|Sitagliptin|The Sitagliptin group includes data from patients randomized to receive treatment with either one (1) 25 mg oral tablet of sitagliptin once daily (blinded) [patients with Creatinine Clearance (CrCl) <30 mL/min or dialysis] or two (2) 25 mg oral tablets of sitagliptin once daily (blinded) [patients with CrCl 30 to <50mL/min] alone or in combination with baseline insulin therapy. During Phase B, patients in the Sitagliptin group (with the exception of patients on baseline insulin therapy and patients who received glycemic rescue medication in Phase A) were given glipizide placebo (blinded). During Phase B, patients on baseline insulin could have their insulin uptitrated, and patients who received glycemic rescue medication in Phase A continued on open-label rescue medication.
564859|NCT00094900|B1|Baseline|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564860|NCT00094900|P1|Participant Flow|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564861|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564862|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564863|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564864|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564865|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564866|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564867|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564868|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564869|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564870|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564871|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564872|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564873|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564874|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564875|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564876|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564877|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564878|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564879|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564880|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564881|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564882|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564883|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564884|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564885|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564886|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564887|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564888|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564889|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564890|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564891|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564892|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564893|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
565235|NCT00094575|O2|Outcome|Standard Open Repair|
564900|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564901|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564902|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564903|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564904|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564905|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564906|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564907|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564908|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564909|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564910|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564911|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564912|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564913|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564914|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564915|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564916|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564917|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564918|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564919|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564920|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564921|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564922|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564923|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564924|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564925|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564926|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564927|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564928|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564929|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564930|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564931|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564932|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564933|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564934|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564935|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564936|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564937|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564938|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564939|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564940|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564941|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564942|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564943|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564944|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564945|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564946|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564947|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564948|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564949|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564950|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564951|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564952|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564953|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564954|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564955|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564956|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564957|NCT00094900|O1|Outcome|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564958|NCT00094900|E1|Reported Event|IL-1 Trap|Subjects received initial dose of 100mg per day for 3 consecutive days and did not receive any more till a disease flare occured
564959|NCT00094887|B3|Baseline|Total|Total of all reporting groups
564960|NCT00094887|B2|Baseline|Placebo|Nitrogen gas
564961|NCT00094887|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
564962|NCT00094887|P2|Participant Flow|Placebo|Nitrogen gas
564963|NCT00094887|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
564964|NCT00094887|O2|Outcome|Placebo|Nitrogen gas
564965|NCT00094887|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
564966|NCT00094887|E2|Reported Event|Placebo|Nitrogen gas
564967|NCT00094887|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide INO
564968|NCT00094861|B3|Baseline|Total|Total of all reporting groups
564969|NCT00094861|B2|Baseline|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564970|NCT00094861|B1|Baseline|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564971|NCT00094861|P2|Participant Flow|Palifermin|"Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses. Concurrent radio/chemotherapy (administered for 6 to 7 weeks) was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 IV infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
564972|NCT00094861|P1|Participant Flow|Placebo|"Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, for a total of 7 doses. Concurrent radio/chemotherapy was given as follows:~standard radiotherapy 2 Gy once daily x 30 to 33 fractions (6 to 7 weeks) for a total target dose of 60 to 66 Gy~paclitaxel 50 mg/m^2 intravenous (IV) infusion on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy)~carboplatin dosed at an area under the curve (AUC) 2.0 IV on Days 1, 8, 15, 22, 29, 36 (and day 43 for those receiving 66 Gy).~Participants subsequently received two 21-day cycles of consolidation chemotherapy with paclitaxel 225 mg/m^2 and carboplatin dosed at AUC 6.0."
564973|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564974|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564975|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
565236|NCT00094575|O1|Outcome|Endovascular Repair|
565237|NCT00094575|O2|Outcome|Standard Open Repair|
564976|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564977|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564978|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564979|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564980|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564981|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564982|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564983|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564984|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564985|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564986|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564987|NCT00094861|O2|Outcome|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564988|NCT00094861|O1|Outcome|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564989|NCT00094861|E2|Reported Event|Palifermin|Participants received a single IV dose of palifermin at 180 μg/kg administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564990|NCT00094861|E1|Reported Event|Placebo|Participants received a single intravenous (IV) dose of placebo administered 3 days before the initiation of concurrent chemo/radiotherapy, then once weekly during Weeks 1 through 6, typically for a total of 7 doses.
564991|NCT00094835|B8|Baseline|Total|Total of all reporting groups
564992|NCT00094835|B7|Baseline|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564993|NCT00094835|B6|Baseline|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564994|NCT00094835|B5|Baseline|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564995|NCT00094835|B4|Baseline|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564996|NCT00094835|B3|Baseline|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564997|NCT00094835|B2|Baseline|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564998|NCT00094835|B1|Baseline|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
564999|NCT00094835|P7|Participant Flow|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565000|NCT00094835|P6|Participant Flow|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565238|NCT00094575|O1|Outcome|Endovascular Repair|
565001|NCT00094835|P5|Participant Flow|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565002|NCT00094835|P4|Participant Flow|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565003|NCT00094835|P3|Participant Flow|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565004|NCT00094835|P2|Participant Flow|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565005|NCT00094835|P1|Participant Flow|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565006|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565007|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565008|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565009|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565010|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565011|NCT00094835|O5|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565012|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565013|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565014|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565015|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565016|NCT00094835|O4|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565017|NCT00094835|O3|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565018|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565019|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565020|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565239|NCT00094575|O2|Outcome|Standard Open Repair|
565240|NCT00094575|O1|Outcome|Endovascular Repair|
565021|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565022|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565023|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565024|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565025|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565026|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565027|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565028|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565029|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565030|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565031|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565032|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565033|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565034|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565035|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565036|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565037|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565038|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565039|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565040|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565084|NCT00094809|P1|Participant Flow|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565041|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565042|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565043|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565044|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565045|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565046|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565047|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565048|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565049|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565050|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565051|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565052|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565053|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565054|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565055|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565056|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565057|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565058|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565059|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565060|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565085|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565061|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565062|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565063|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565064|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565065|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565066|NCT00094835|O7|Outcome|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565067|NCT00094835|O6|Outcome|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565068|NCT00094835|O5|Outcome|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565069|NCT00094835|O4|Outcome|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565070|NCT00094835|O3|Outcome|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565071|NCT00094835|O2|Outcome|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565072|NCT00094835|O1|Outcome|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565073|NCT00094835|E7|Reported Event|Panitumumab + Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received panitumumab 9.0 mg/kg, paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by IV infusion on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565074|NCT00094835|E6|Reported Event|Panitumumab + Motesanib 75 mg BID|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 75 mg BID, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565075|NCT00094835|E5|Reported Event|Panitumumab + Motesanib 125 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 125 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565076|NCT00094835|E4|Reported Event|Panitumumab + Motesanib 50 mg QD|Participants with no more than one prior chemotherapy regimen for NSCLC received panitumumab 9.0 mg/kg IV on Day 1 of each 21-day cycle, and motesanib 50 mg QD, orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565077|NCT00094835|E3|Reported Event|Paclitaxel/Carboplatin + Motesanib 75 mg BID|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 75 mg twice daily (BID) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565078|NCT00094835|E2|Reported Event|Paclitaxel/Carboplatin + Motesanib 125 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 125 mg QD orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565079|NCT00094835|E1|Reported Event|Paclitaxel/Carboplatin + Motesanib 50 mg QD|Chemotherapy naïve participants received paclitaxel 200 mg/m^2 and carboplatin chemotherapy administered by intravenous (IV) infusion on Day 1 of each 21-day cycle, and motesanib, 50 mg once daily (QD) orally self-administered on Days 3-21 of Cycle 1 and then on Days 1 to 21 of Cycle 2 and all cycles thereafter.
565080|NCT00094809|B3|Baseline|Total|Total of all reporting groups
565081|NCT00094809|B2|Baseline|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565082|NCT00094809|B1|Baseline|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565087|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565088|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565089|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565090|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565091|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565092|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565093|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565094|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565095|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565096|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565097|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565098|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565099|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565100|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565101|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565102|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565103|NCT00094809|O2|Outcome|Placebo|Placebo administered by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565104|NCT00094809|O1|Outcome|Pegfilgrastim (Neulasta)|Pegfilgrastim 6 mg by subcutaneous injection once every 2 weeks at least 24 hours after 5-fluorouracil infusion
565105|NCT00094809|E2|Reported Event|Pegfilgrastim|
565106|NCT00094809|E1|Reported Event|Placebo|
565107|NCT00094770|B3|Baseline|Total|Total of all reporting groups
565108|NCT00094770|B2|Baseline|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565109|NCT00094770|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565110|NCT00094770|P2|Participant Flow|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565111|NCT00094770|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565112|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565113|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565114|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565115|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565116|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565117|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565118|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565119|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565120|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565121|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565122|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565123|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565124|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565125|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565126|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565127|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565128|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565129|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565130|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565131|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565132|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565133|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565134|NCT00094770|O2|Outcome|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565135|NCT00094770|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565136|NCT00094770|E2|Reported Event|Glipizide|The Glipizide group includes data from patients randomized to receive treatment with glipizide initiated at a dose of 1 tablet (5 mg) per day. Patients could then up-titrated to a total daily dose of 4 tablets twice daily (20mg/day) based on their glycemic control.
565137|NCT00094770|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily.
565138|NCT00094757|B4|Baseline|Total|Total of all reporting groups
565139|NCT00094757|B3|Baseline|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565140|NCT00094757|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565141|NCT00094757|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565142|NCT00094757|P3|Participant Flow|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565143|NCT00094757|P2|Participant Flow|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565144|NCT00094757|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565145|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565146|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565147|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565148|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565149|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565150|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565151|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565152|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565153|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565154|NCT00094757|O3|Outcome|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565155|NCT00094757|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565241|NCT00094575|O2|Outcome|Standard Open Repair|
565242|NCT00094575|O1|Outcome|Endovascular Repair|
565156|NCT00094757|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565157|NCT00094757|E3|Reported Event|Placebo/Pioglitazone|The Placebo/Pioglitazone got 2 sitagliptin matching placebo tablets once daily in Weeks 0- 54 and pioglitazone 30 mg/day once daily in Weeks 18-54.
565158|NCT00094757|E2|Reported Event|Sitagliptin 200 mg|The Sitagliptin 200 mg got 2 sitagliptin 100 mg tablets once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565159|NCT00094757|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg got 1 sitagliptin 100 mg tablet and 1 sitagliptin matching placebo tablet once daily Weeks 0-54 and pioglitazone placebo once daily in Weeks 18-54.
565160|NCT00094653|B4|Baseline|Total|Total of all reporting groups
565161|NCT00094653|B3|Baseline|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565162|NCT00094653|B2|Baseline|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565163|NCT00094653|B1|Baseline|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565164|NCT00094653|P3|Participant Flow|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565165|NCT00094653|P2|Participant Flow|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565166|NCT00094653|P1|Participant Flow|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565167|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565168|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565169|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565170|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565171|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565185|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565243|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
565172|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565173|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565174|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565175|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565176|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565177|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565178|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565179|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565180|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565181|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565182|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565183|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565184|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565244|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
565245|NCT00094575|O2|Outcome|Open Repair|Standard Open Repair
565246|NCT00094575|O1|Outcome|Endovascular Repair|Endovascular Repair
565186|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565187|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565188|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565189|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565190|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565191|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565192|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565193|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565194|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565195|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565196|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565197|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565198|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565212|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565199|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565200|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565201|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565202|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565203|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565204|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565205|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565206|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565207|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565208|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565209|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565210|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565211|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565228|NCT00094575|B1|Baseline|Endovascular Repair|Endovascular Repair
565229|NCT00094575|P2|Participant Flow|Open Repair|Standard Open Repair
565213|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565214|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565215|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565216|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565217|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565218|NCT00094653|O3|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565219|NCT00094653|O2|Outcome|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565220|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565221|NCT00094653|O2|Outcome|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565222|NCT00094653|O1|Outcome|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565223|NCT00094653|E3|Reported Event|gp100|Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565224|NCT00094653|E2|Reported Event|Ipilimumab Plus gp100|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with gp100. Gp100 consisted of 2 separate peptide components: Peptide A, a peptide with sequence YLEPGPVTV (gp100:280-288[288V]) and Peptide B, a peptide with the sequence IMDQVPFSV (gp100:209-217[210M]). Each peptide was prepared with Montanide ISA-51. One dose of gp100 consisted of the administration of Peptide A, at a dosage of 2 mL or 1 mg, and Peptide B, at a dosage of 2 mL or 1 mg. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565225|NCT00094653|E1|Reported Event|Ipilimumab Monotherapy|Ipilimumab was administered at a dosage of 3 mg/kg as an intravenous (IV) infusion administered over 90 minutes every 3 weeks for a total of 4 doses, together with matching vaccine placebo. The vaccine placebo consisted of sterile 0.9% sodium chloride. After Week 12, subjects who met re-induction criteria could receive further cycles of their randomized study therapy.
565226|NCT00094575|B3|Baseline|Total|Total of all reporting groups
565227|NCT00094575|B2|Baseline|Open Repair|Standard Open Repair
565248|NCT00094575|E1|Reported Event|Endovascular Repair|Endovascular Repair
565249|NCT00094497|B3|Baseline|Total|Total of all reporting groups
565250|NCT00094497|B2|Baseline|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565251|NCT00094497|B1|Baseline|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565252|NCT00094497|P2|Participant Flow|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565253|NCT00094497|P1|Participant Flow|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565254|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565255|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565256|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565257|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565258|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565259|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565260|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565261|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565262|NCT00094497|O2|Outcome|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565263|NCT00094497|O1|Outcome|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565264|NCT00094497|E2|Reported Event|Sz-M|"streptozotocin and mitotane~Streptozotocin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (EDP-M)"
565265|NCT00094497|E1|Reported Event|EDP-M|"etopodide, doxorubicin, cisplatin and mitotane~Etoposide~Doxorubicin~Cisplatin~Mitotane~participants who progressed during first line therapy, were eligible to the alternative treatment (Sz-M)"
565266|NCT00094458|B4|Baseline|Total|Total of all reporting groups
565267|NCT00094458|B3|Baseline|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565268|NCT00094458|B2|Baseline|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565269|NCT00094458|B1|Baseline|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565270|NCT00094458|P6|Participant Flow|Infliximab + Azathioprine/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
565271|NCT00094458|P5|Participant Flow|Infliximab + Placebo/Infliximab|Participants received Placebo oral capsules daily and IFX infusions 5mg/kg through Week 50. IFX infusions 5mg/kg in one year country specific (EU and Israel) Open-Label Extension.
565272|NCT00094458|P4|Participant Flow|Azathioprine + Placebo/Infliximab|Participants received daily AZA oral capsules 2.5mg/kg/day and Placebo infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (EU and Israel) open-Label Extension.
565273|NCT00094458|P3|Participant Flow|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565287|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565274|NCT00094458|P2|Participant Flow|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565275|NCT00094458|P1|Participant Flow|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565276|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565277|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565278|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565279|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565280|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565281|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565282|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565283|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565284|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565285|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565286|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565332|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565583|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565584|NCT00092677|O2|Outcome|Placebo|
565288|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565289|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565290|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565291|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565292|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565293|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565294|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565295|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565296|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565297|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565298|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565299|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565300|NCT00094458|O3|Outcome|Infliximab + Azathioprine|Participants received infliximab infusions 5 mg/kg body weight of participant along with daily AZA capsules 2.5 mg/kg body weight of participant in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565585|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565586|NCT00092677|O2|Outcome|Placebo|
565301|NCT00094458|O2|Outcome|Infliximab + Placebo|Participants received infliximab (IFX) infusions 5 mg/kg body weight of participant along with placebo capsules daily in main study through Week 30. Participants who completed treatment in the main study and, in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565302|NCT00094458|O1|Outcome|Azathioprine + Placebo|Participants received placebo (PBO) infusions and daily Azathioprine (AZA) capsules in main study through Week 30. Participants who completed treatment in the main study and in the opinion of investigator, had benefited from continued treatment were entered in the study extension and received same assigned treatments (which they were receiving in main study) from Week 30 to 46. Those who completed treatment in the study extension may enter in country specific (EU and Israel) OLE.
565303|NCT00094458|E9|Reported Event|OLE-Infliximab + Azathioprine/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
565304|NCT00094458|E8|Reported Event|OLE-Infliximab + Placebo/Infliximab|Placebo (PBO) oral capsules daily and infliximab (IFX) infusions 5mg/kg through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
565305|NCT00094458|E7|Reported Event|OLE-Azathioprine + Placebo/Infliximab|Azathioprine (AZA) oral capsules daily 2.5mg/kg/day and Placebo (PBO) infusion through Week 50. Infliximab (IFX) infusions 5mg/kg in one year country specific (UE and Israel) Open-Label Extension.
565306|NCT00094458|E6|Reported Event|W50-Infliximab + Azathioprine|Azathioprine (AZA) oral capsules daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
565307|NCT00094458|E5|Reported Event|W50-Infliximab + Placebo|Placebo (PBO) oral capsules daily and Infliximab (IFX) infusions 5 mg/kg Week 30 through Week 50.
565308|NCT00094458|E4|Reported Event|W50-Azathioprine + Placebo|(AZA) oral daily 2.5 mg/kg/day and Placebo (PBO) infusion Week 30 through Week 50.
565309|NCT00094458|E3|Reported Event|W30-Infliximab + Azathioprine|Azathioprine (AZA) oral daily 2.5 mg/kg/day and Infliximab (IFX) infusions 5mg/kg through Week 30.
565310|NCT00094458|E2|Reported Event|W30-Infliximab + Placebo|Placebo (PBO) oral daily and Infliximab (IFX) infusions 5 mg/kg through Week 30.
565311|NCT00094458|E1|Reported Event|W30-Azathioprine + Placebo|Azathioprine (AZA) oral capsules 2.5 mg/kg/day and Placebo (PBO) infusion through Week 30.
565312|NCT00094328|B1|Baseline|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565313|NCT00094328|P1|Participant Flow|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565314|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565315|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565316|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565317|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565318|NCT00094328|O1|Outcome|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565319|NCT00094328|E1|Reported Event|Open Label Bicalutamide With Anastrozole|Patients were given study drugs (bicalutamide and anastrozole) daily for 12 months through individual titration to optimal doses of each drug independently
565320|NCT00094302|B3|Baseline|Total|Total of all reporting groups
565321|NCT00094302|B2|Baseline|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565322|NCT00094302|B1|Baseline|Placebo|Placebo of spironolactone
565323|NCT00094302|P2|Participant Flow|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565324|NCT00094302|P1|Participant Flow|Placebo|Placebo of spironolactone
565325|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565326|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565327|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565328|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565329|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565330|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565331|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565333|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565334|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565335|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565336|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565337|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565338|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565339|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565340|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565341|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565342|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565343|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565344|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565345|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565346|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565347|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565348|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565349|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565350|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565351|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565352|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565353|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565354|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565355|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565356|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565357|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565358|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565359|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565360|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565361|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565362|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565363|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565364|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565365|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565366|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565587|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565367|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565368|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565369|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565370|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565371|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565372|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565373|NCT00094302|O2|Outcome|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565374|NCT00094302|O1|Outcome|Placebo|Placebo of spironolactone
565375|NCT00094302|E2|Reported Event|Spironolactone|Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.
565376|NCT00094302|E1|Reported Event|Placebo|Placebo of spironolactone
565377|NCT00094172|B3|Baseline|Total|Total of all reporting groups
565378|NCT00094172|B2|Baseline|Placebo|Non-Active Comparator
565379|NCT00094172|B1|Baseline|Atorvastatin|Drug: Atorvastatin
565380|NCT00094172|P2|Participant Flow|Placebo|Non-Active Comparator
565381|NCT00094172|P1|Participant Flow|Atorvastatin|Drug: Atorvastatin
565382|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
565383|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
565384|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
565385|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
565386|NCT00094172|O2|Outcome|Placebo|Non-Active Comparator
565387|NCT00094172|O1|Outcome|Atorvastatin|Drug: Atorvastatin
565388|NCT00094172|E2|Reported Event|Placebo|Non-Active Comparator
565389|NCT00094172|E1|Reported Event|Atorvastatin|Drug: Atorvastatin
565390|NCT00094107|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565391|NCT00094107|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565392|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565393|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565394|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565395|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565396|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565397|NCT00094107|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565398|NCT00094107|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
565399|NCT00094094|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565400|NCT00094094|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565401|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565402|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565403|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565404|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565405|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565588|NCT00092677|O2|Outcome|Placebo|
565406|NCT00094094|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565407|NCT00094094|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565408|NCT00094055|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565409|NCT00094055|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565410|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565411|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565412|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565413|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565414|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565415|NCT00094055|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565416|NCT00094055|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 mg BID in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred or the participant withdrew consent.
565417|NCT00093847|B3|Baseline|Total|Total of all reporting groups
565418|NCT00093847|B2|Baseline|Oral Adjunct Placebo|Participants receiving placebo
565419|NCT00093847|B1|Baseline|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
565420|NCT00093847|P2|Participant Flow|Oral Adjunct Placebo|Participants receiving placebo
565421|NCT00093847|P1|Participant Flow|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
565422|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
565423|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
565424|NCT00093847|O2|Outcome|Oral Adjunct Placebo|Participants receiving placebo
565425|NCT00093847|O1|Outcome|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
565426|NCT00093847|E2|Reported Event|Oral Adjunct Placebo|Participants receiving placebo
565427|NCT00093847|E1|Reported Event|Adjunct Oral SAMe Tosylate 800mg PO BiD|Participants receiving the oral SAMe tosylate
565428|NCT00093808|B1|Baseline|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565429|NCT00093808|P1|Participant Flow|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565430|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565431|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565432|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565433|NCT00093808|O1|Outcome|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565434|NCT00093808|E1|Reported Event|Capecitabine + Vinorelbine + Trastuzumab|Treatment followed a 21-day cycle. Capecitabine was administered orally twice daily at a dose of 825 mg/m^2 on days 1 to 14, vinorelbine was administered intravenously (IV) at a dose of 25 mg/m^2 on days 1 and 8 every 3 weeks, and trastuzumab was administered IV at a dose of 6 mg/kg on day 1 of every 3-week cycle (except cycle 1, when patients were given a loading dose of 8 mg/kg).
565435|NCT00093782|B1|Baseline|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565436|NCT00093782|P1|Participant Flow|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565437|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565438|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565439|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565440|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565441|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565442|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565443|NCT00093782|O1|Outcome|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565444|NCT00093782|E1|Reported Event|Treatment (Temsirolimus)|"Patients receive CCI-779 IV over 30 minutes on days 1, 8, 15, and 22. Treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a CR or PR receive 2 additional courses beyond CR or PR.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
565445|NCT00093756|B3|Baseline|Total|Total of all reporting groups
565446|NCT00093756|B2|Baseline|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
565447|NCT00093756|B1|Baseline|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy > bortezomib: Given IV > paclitaxel: Given IV > carboplatin: Given IV
565448|NCT00093756|P2|Participant Flow|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, , carboplatin: Given IV.
565449|NCT00093756|P1|Participant Flow|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
565450|NCT00093756|O1|Outcome|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
565451|NCT00093756|E2|Reported Event|PhaseII|PHASE II: Patients receive as in phase I at the MTD. Patients also undergo radiotherapy as in phase I. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
565452|NCT00093756|E1|Reported Event|PhaseI|PHASE I: Cohorts of 3-6 patients receive escalating doses of study medications until the maximum tolerated dose (MTD) is determined. 3-dimensional conformal radiation therapy, bortezomib: Given IV, paclitaxel: Given IV, carboplatin: Given IV.
565453|NCT00093496|B3|Baseline|Total|Total of all reporting groups
565454|NCT00093496|B2|Baseline|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565455|NCT00093496|B1|Baseline|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565533|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565456|NCT00093496|P2|Participant Flow|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565457|NCT00093496|P1|Participant Flow|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565458|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565459|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565460|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565461|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565462|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565463|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565464|NCT00093496|O2|Outcome|Cohort 2 (Prior Gemcitabine Exposure)|Patients with prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565465|NCT00093496|O1|Outcome|Cohort 1 (No Prior Gemcitabine Exposure)|Patients with no prior gemcitabine exposure receive tanespimycin IV over 2 hours on days 1 and 8 during course 1 and days 2 and 9 during subsequent courses and gemcitabine hydrochloride IV over 30 minutes on day 7 during course 1 and days 1 and 8 during subsequent courses. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months until disease progression and then every 6 months for up to 5 years.
565466|NCT00093496|E1|Reported Event|All Patients Receiving Gemcitabine|All patients receiving gemcitabine were combined to analyze toxicity.
565467|NCT00093470|B3|Baseline|Total|Total of all reporting groups
565468|NCT00093470|B2|Baseline|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
565469|NCT00093470|B1|Baseline|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
565470|NCT00093470|P2|Participant Flow|Arm B (Clinical Observation)|"Patients undergo observation only.~Clinical Observation: Undergo observation"
565471|NCT00093470|P1|Participant Flow|Arm A (Tipifarnib)|"Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Tipifarnib: Given PO"
565472|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
565473|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
565474|NCT00093470|O2|Outcome|Arm B (Clinical Observation)|Patients undergo observation only.
565475|NCT00093470|O1|Outcome|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
565476|NCT00093470|E2|Reported Event|Arm B (Clinical Observation)|Patients undergo observation only.
565477|NCT00093470|E1|Reported Event|Arm A (Tipifarnib)|Patients receive tipifarnib PO BID on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
565577|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565578|NCT00092677|O2|Outcome|Placebo|
565478|NCT00093379|B1|Baseline|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
565479|NCT00093379|P1|Participant Flow|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy (XRT) once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor.
565480|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
565481|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
565482|NCT00093379|O1|Outcome|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
565483|NCT00093379|E1|Reported Event|Capecitabine + Oxaliplatin + XRT|Capecitabine (825 mg/m^2 twice a day, Monday-Friday during weeks 1, 2, 4, and 5) and Oxaliplatin (50 mg/m^2, Days 1, 8, 22, 29) during the duration of radiation therapy only. Radiotherapy once daily on days 1-3, 6-10, 13-17, 20-24, 27-31, 34-38, and 41-42. Participants with T3-4 lesions undergo radiotherapy once daily on days 43 and 44. The final dose of radiation therapy determined by the T stage of the primary tumor. Radiotherapy = XRT.
565484|NCT00093145|B1|Baseline|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565485|NCT00093145|P1|Participant Flow|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565486|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565487|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565488|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565489|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565579|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565490|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565491|NCT00093145|O1|Outcome|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565492|NCT00093145|E1|Reported Event|Albumin-bound Paclitaxel, Carboplatin + Herceptin|Participants received albumin-bound paclitaxel, 100 mg/m^2 weekly every 3 out of 4 weeks, carboplatin at an area under the curve (AUC) = 6 every 4 weeks and Herceptin weekly, 4 mg/kg the first week and 2 mg/kg on all subsequent weeks by intravenous (IV) infusion for up to 6 cycles in the absence of disease progression or intolerable toxicity. Participants could continue treatment with chemotherapy beyond 6 cycles at the discretion of the investigator, but Herceptin therapy was to continue to be administered weekly (2 mg/kg) until intercurrent illness, disease progression, unacceptable toxicity, patient withdrawal or administration of any non-protocol anti-cancer treatment.
565493|NCT00093041|B7|Baseline|Total|Total of all reporting groups
565494|NCT00093041|B6|Baseline|Zalutumumab 8 mg/kg|
565495|NCT00093041|B5|Baseline|Zalutumumab 4 mg/kg|
565496|NCT00093041|B4|Baseline|Zalutumumab 2 mg/kg|
565497|NCT00093041|B3|Baseline|Zalutumumab 1 mg/kg|
565498|NCT00093041|B2|Baseline|Zalutumumab 0.5 mg/kg|
565499|NCT00093041|B1|Baseline|Zalutumumab 0.15 mg/kg|
565500|NCT00093041|P6|Participant Flow|Zalutumumab 8 mg/kg|
565501|NCT00093041|P5|Participant Flow|Zalutumumab 4 mg/kg|
565502|NCT00093041|P4|Participant Flow|Zalutumumab 2 mg/kg|
565503|NCT00093041|P3|Participant Flow|Zalutumumab 1 mg/kg|
565504|NCT00093041|P2|Participant Flow|Zalutumumab 0.5 mg/kg|
565505|NCT00093041|P1|Participant Flow|Zalutumumab 0.15 mg/kg|
565506|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
565507|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
565508|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
565509|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
565510|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
565511|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
565512|NCT00093041|O6|Outcome|Zalutumumab 8 mg/kg|
565513|NCT00093041|O5|Outcome|Zalutumumab 4 mg/kg|
565514|NCT00093041|O4|Outcome|Zalutumumab 2 mg/kg|
565515|NCT00093041|O3|Outcome|Zalutumumab 1 mg/kg|
565516|NCT00093041|O2|Outcome|Zalutumumab 0.5 mg/kg|
565517|NCT00093041|O1|Outcome|Zalatumumab 0.15 mg/kg|
565518|NCT00093041|E6|Reported Event|Zalutumumab 8 mg/kg|
565519|NCT00093041|E5|Reported Event|Zalutumumab 4 mg/kg|
565520|NCT00093041|E4|Reported Event|Zalutumumab 2 mg/kg|
565521|NCT00093041|E3|Reported Event|Zalutumumab 1 mg/kg|
565522|NCT00093041|E2|Reported Event|Zalutumumab 0.5 mg/kg|
565523|NCT00093041|E1|Reported Event|Zalutumumab 0.15 mg/kg|
565524|NCT00093015|B3|Baseline|Total|Total of all reporting groups
565525|NCT00093015|B2|Baseline|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565526|NCT00093015|B1|Baseline|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565527|NCT00093015|P2|Participant Flow|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565528|NCT00093015|P1|Participant Flow|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565529|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565530|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565531|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565532|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565580|NCT00092677|O2|Outcome|Placebo|
565581|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565582|NCT00092677|O2|Outcome|Placebo|
565534|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565535|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565536|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565537|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565538|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565539|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565540|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565541|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565542|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565543|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565544|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565545|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565546|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565547|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565548|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565549|NCT00093015|O2|Outcome|Darbepoetin Alfa|Subcutaneous darbepoetin alfa at a starting dose of 75 mcg/kg once every 2 weeks, titrated to maintain a hemoglobin concentration of 13.0 g/dL. Dosing was switched to once monthly when two consecutive hemoglobin concentrations between 12.0 and 13.5 g/dL were observed.
565550|NCT00093015|O1|Outcome|Placebo|Subcutaneous placebo when hemoglobin concentration was ≥ 9.0 g/dL. Received subcutaneous rescue therapy (once monthly) with darbepoetin alfa in a blinded fashion if the hemoglobin concentration was <9.0 g/dL until the hemoglobin concentration was ≥ 9.0 g/dL.
565551|NCT00093015|E2|Reported Event|Darbepoetin Alfa|
565552|NCT00093015|E1|Reported Event|Placebo|
565553|NCT00092677|B3|Baseline|Total|Total of all reporting groups
565554|NCT00092677|B2|Baseline|Placebo|
565555|NCT00092677|B1|Baseline|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565556|NCT00092677|P2|Participant Flow|Placebo|
565557|NCT00092677|P1|Participant Flow|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565558|NCT00092677|O2|Outcome|Placebo|
565559|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565560|NCT00092677|O2|Outcome|Placebo|
565561|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565562|NCT00092677|O2|Outcome|Placebo|
565563|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565564|NCT00092677|O2|Outcome|Placebo|
565565|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565566|NCT00092677|O2|Outcome|Placebo|
565567|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565568|NCT00092677|O2|Outcome|Placebo|
565569|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565570|NCT00092677|O2|Outcome|Placebo|
565571|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565572|NCT00092677|O2|Outcome|Placebo|
565573|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565574|NCT00092677|O2|Outcome|Placebo|
565575|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565576|NCT00092677|O2|Outcome|Placebo|
565589|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565590|NCT00092677|O2|Outcome|Placebo|
565591|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565592|NCT00092677|O2|Outcome|Placebo|
565593|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565594|NCT00092677|O2|Outcome|Placebo|
565595|NCT00092677|O1|Outcome|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565596|NCT00092677|E2|Reported Event|Placebo|
565597|NCT00092677|E1|Reported Event|EZ/Simva 10/40 mg|Ezetimibe 10 mg + Simvastatin 40 mg
565598|NCT00092547|B3|Baseline|Total|Total of all reporting groups
565599|NCT00092547|B2|Baseline|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
565600|NCT00092547|B1|Baseline|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565601|NCT00092547|P3|Participant Flow|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565602|NCT00092547|P2|Participant Flow|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6.
565603|NCT00092547|P1|Participant Flow|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6.
565604|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565605|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565606|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565607|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565608|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565609|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565610|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565611|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represent participants randomized to the qHPV vaccine group
565612|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565613|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565614|NCT00092547|O1|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565615|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565616|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565617|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565618|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565619|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565620|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565621|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565622|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565623|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565624|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565625|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565680|NCT00092495|B4|Baseline|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565626|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565627|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565628|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565629|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565630|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565631|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565632|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565633|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565634|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
565635|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565636|NCT00092547|O2|Outcome|qHPV Vaccine in Extension Study|Represent participants originally enrolled into the Placebo Group who continued in the study to receive 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36.
565637|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565638|NCT00092547|O2|Outcome|Placebo in Base Study|Represents participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo at Day 1, Month 2, and Month 6
565639|NCT00092547|O1|Outcome|qHPV Vaccine in Base Study|Represents participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of V501 (qHPV) at Day 1, Month 2, and Month 6
565640|NCT00092547|E4|Reported Event|qHPV Vaccine in Extension: Extension and Long-term Follow-up|Participants who received placebo in the Base Study and three 0.5 mL intramuscular injections of V501 (qHPV) at Month 30, Month 32, and Month 36 in the Extension Study. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
565641|NCT00092547|E3|Reported Event|qHPV Vaccine in Base: Extension and Long-term Follow-up|Participants who received qHPV in the Base Study. No study treatment was administered after Month 6 for these participants. Adverse events are reported for this group from Month 30 to Month 126. Non-serious AEs were not solicited.
565642|NCT00092547|E2|Reported Event|Placebo in Base: Vaccine Phase and Follow-up|"Participants who were randomized into the Placebo Group, who received three 0.5 mL intramuscular injections of placebo vaccine at Day 1, Month 2, and Month 6, and had safety followup.~Adverse events are reported for this group from Day 1 to Month 30."
565643|NCT00092547|E1|Reported Event|qHPV Vaccine in Base: Vaccine Phase and Follow-up|Participants who were randomized into the qHPV Group, who received three 0.5 mL intramuscular injections of qHPV at Day 1, Month 2, and Month 6, and had safety follow-up. Adverse events are reported for this group from Day 1 to Month 30.
565644|NCT00092534|B3|Baseline|Total|Total of all reporting groups
565645|NCT00092534|B2|Baseline|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565646|NCT00092534|B1|Baseline|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565647|NCT00092534|P3|Participant Flow|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
565648|NCT00092534|P2|Participant Flow|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565649|NCT00092534|P1|Participant Flow|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565864|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565650|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565651|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565652|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565653|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565654|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565655|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565656|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565657|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565658|NCT00092534|O2|Outcome|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565659|NCT00092534|O1|Outcome|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565660|NCT00092534|E3|Reported Event|Extension Study|"This group includes 581 subjects who received placebo during the base study, (Group 2-Base Study) and 13 additional subjects who were randomized to the active vaccine arm of the base study (from Group 1-Base Study), but received fewer than the full three doses of Quadrivalent HPV vaccine during the base study. Subjects designated as Completed Period are those who received three doses of Quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up.~Extension study includes subjects from Group 2-Base Study who were vaccinated with quadrivalent HPV vaccine.~No data on non-serious adverse events were collected on this group during the extension study, hence no data are entered for them in the table."
565661|NCT00092534|E2|Reported Event|Placebo (Group 2)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565662|NCT00092534|E1|Reported Event|Quadrivalent Human Papillomavirus Vaccine (Group 1)|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565663|NCT00092521|B4|Baseline|Total|Total of all reporting groups
565664|NCT00092521|B3|Baseline|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565665|NCT00092521|B2|Baseline|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565666|NCT00092521|B1|Baseline|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565667|NCT00092521|P4|Participant Flow|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
565668|NCT00092521|P3|Participant Flow|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565669|NCT00092521|P2|Participant Flow|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study.~Group 2 Base Study Monovalent HPV (Type 16) Vaccine was not part of the pre-specified efficacy analysis population."
565670|NCT00092521|P1|Participant Flow|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent Human papillomavirus (HPV) vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565671|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565672|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565673|NCT00092521|O2|Outcome|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565674|NCT00092521|O1|Outcome|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565675|NCT00092521|E4|Reported Event|Group 4 - Quadrivalent Human Papillomavirus Vaccine Extension|"This group includes subjects who entered the extension including subjects who in the base study received fewer than the full three doses of Quadrivalent HPV vaccine during the base study (i.e., subjects who received placebo in the base study; subjects who received monovalent [type 16] HPV vaccine in the base study, or subjects who received <=2 doses of quadrivalent HPV vaccine in the base study). Subjects who discontinued the base portion of the study could enter the extension portion of the study. In the extension period subjects designated as Completed Period are those who received three doses of quadrivalent HPV vaccine and completed all required follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
565676|NCT00092521|E3|Reported Event|Group 3 - Base Study Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 3 were vaccinated (at Day 1, Month 2 and Month 6) with placebo.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received placebo; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565677|NCT00092521|E2|Reported Event|Group 2 - Base Study Monovalent HPV (Type 16) Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 2 were vaccinated (at Day 1, Month 2 and Month 6) with the Monovalent (HPV 16) HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Monovalent (HPV 16) HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565678|NCT00092521|E1|Reported Event|Group 1 - Base Study Quadrivalent Human Papillomavirus Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time study subjects in Group 1 were vaccinated (at Day 1, Month 2 and Month 6) with the Quadrivalent HPV vaccine.~The Follow-up Period for the Base Study encompassed the follow-up of subjects who had received the Quadrivalent HPV vaccine; from completion of the Vaccination Period at Month 7 through Month 48 of the study."
565679|NCT00092495|B5|Baseline|Total|Total of all reporting groups
565681|NCT00092495|B3|Baseline|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565682|NCT00092495|B2|Baseline|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565683|NCT00092495|B1|Baseline|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565684|NCT00092495|P5|Participant Flow|Extension Study|"Extension Study: This group includes 12 subjects who participated in the base study and received either a partial dose formulation of the quadrivalent HPV vaccine in the base study and did not meet the protocol specified criteria for seroconversion, or subjects who, due to pregnancy, received 1 or 2 doses of the quadrivalent HPV vaccine in the base study and remained in the study through Month 7. The Extension Period began after all patients had completed the Month 7 follow-up period. Subjects designated as Completed Period are those who at the end of the study had received three injections of quadrivalent HPV vaccine and completed all follow-up visits. Subjects designated as Not Completed are those who: a) Received all three vaccinations, but did not complete follow-up; b) Did not receive all vaccinations, but completed follow-up, or c) Did not receive all vaccinations, and did not complete follow-up."
565685|NCT00092495|P4|Participant Flow|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565686|NCT00092495|P3|Participant Flow|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565687|NCT00092495|P2|Participant Flow|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565688|NCT00092495|P1|Participant Flow|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565689|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565690|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565691|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565692|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565693|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565694|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565695|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565696|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565697|NCT00092495|O3|Outcome|Women 16-23 Years|
565698|NCT00092495|O2|Outcome|Boys 10-15 Years|
565699|NCT00092495|O1|Outcome|Girls 10-15 Years|
565700|NCT00092495|O3|Outcome|Women 16-23 Years|
565701|NCT00092495|O2|Outcome|Boys 10-15 Years|
565702|NCT00092495|O1|Outcome|Girls 10-15 Years|
565703|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565704|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565705|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565706|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565707|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565708|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565709|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565710|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565711|NCT00092495|O3|Outcome|Women 16-23 Years|
565712|NCT00092495|O2|Outcome|Boys 10-15 Years|
565713|NCT00092495|O1|Outcome|Girls 10-15 Years|
565714|NCT00092495|O3|Outcome|Women 16-23 Years|
565715|NCT00092495|O2|Outcome|Boys 10-15 Years|
565716|NCT00092495|O1|Outcome|Girls 10-15 Years|
565717|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565718|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565719|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565720|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565721|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565722|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565723|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565724|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565725|NCT00092495|O3|Outcome|Women 16-23 Years|
565726|NCT00092495|O2|Outcome|Boys 10-15 Years|
565727|NCT00092495|O1|Outcome|Girls 10-15 Years|
565728|NCT00092495|O3|Outcome|Women 16-23 Years|
565729|NCT00092495|O2|Outcome|Boys 10-15 Years|
565730|NCT00092495|O1|Outcome|Girls 10-15 Years|
565731|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565732|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565733|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565734|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565735|NCT00092495|O4|Outcome|100% Formulation qHPV Vaccine|Subjects in this group received a 100% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565736|NCT00092495|O3|Outcome|60% Formulation qHPV Vaccine|Subjects in this group received a 60% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6
565737|NCT00092495|O2|Outcome|40% Formulation qHPV Vaccine|Subjects in this group received a 40% dose formulation of the qHPV vaccine at Day 1, Month 2, and Month 6.
565738|NCT00092495|O1|Outcome|20% Formulation qHPV Vaccine|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565739|NCT00092495|O3|Outcome|Women 16-23 Years|
565740|NCT00092495|O2|Outcome|Boys 10-15 Years|
565741|NCT00092495|O1|Outcome|Girls 10-15 Years|
565742|NCT00092495|O3|Outcome|Women 16-23 Years|
565743|NCT00092495|O2|Outcome|Boys 10-15 Years|
565744|NCT00092495|O1|Outcome|Girls 10-15 Years|
565745|NCT00092495|E4|Reported Event|100% Formulation|Subjects in this group received a 100% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565746|NCT00092495|E3|Reported Event|60% Formulation|Subjects in this group received a 60% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565747|NCT00092495|E2|Reported Event|40% Formulation|Subjects in this group received a 40% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565748|NCT00092495|E1|Reported Event|20% Formulation|Subjects in this group received a 20% dose formulation of the quadrivalent human papillomavirus (qHPV) vaccine at Day 1, Month 2, and Month 6.
565749|NCT00092456|B5|Baseline|Total|Total of all reporting groups
565750|NCT00092456|B4|Baseline|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565751|NCT00092456|B3|Baseline|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565752|NCT00092456|B2|Baseline|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565753|NCT00092456|B1|Baseline|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565754|NCT00092456|P4|Participant Flow|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination
565755|NCT00092456|P3|Participant Flow|RotaTeq™ Lot 3|Three oral doses (~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565756|NCT00092456|P2|Participant Flow|RotaTeq™ Lot 2|Three oral doses (~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565757|NCT00092456|P1|Participant Flow|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565758|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565759|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565760|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565761|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565762|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565763|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565764|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565765|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565766|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565767|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565768|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565769|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565770|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565771|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565772|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565773|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565774|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565775|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565776|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565777|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565778|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565779|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565780|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565781|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565782|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565783|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565784|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565785|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565786|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565787|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565788|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565789|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565908|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565909|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565790|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565791|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565792|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565793|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565794|NCT00092456|O4|Outcome|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565795|NCT00092456|O3|Outcome|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565796|NCT00092456|O2|Outcome|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565797|NCT00092456|O1|Outcome|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565798|NCT00092456|E4|Reported Event|Placebo|Placebo-matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565799|NCT00092456|E3|Reported Event|RotaTeq™ Lot 3|Three oral doses ( ~6.91 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565800|NCT00092456|E2|Reported Event|RotaTeq™ Lot 2|Three oral doses ( ~8.01 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565801|NCT00092456|E1|Reported Event|RotaTeq™ Lot 1|Three oral doses (~8.81 X 10^7 IU/Dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow up after each vaccination.
565802|NCT00092443|B3|Baseline|Total|Total of all reporting groups
565803|NCT00092443|B2|Baseline|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565804|NCT00092443|B1|Baseline|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565805|NCT00092443|P2|Participant Flow|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565806|NCT00092443|P1|Participant Flow|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and followup for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565807|NCT00092443|O10|Outcome|Placebo Matching RotaTeq™ (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565808|NCT00092443|O9|Outcome|Placebo Matching RotaTeq™ (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565809|NCT00092443|O8|Outcome|Placebo Matching RotaTeq™ (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565810|NCT00092443|O7|Outcome|Placebo Matching RotaTeq™ (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565811|NCT00092443|O6|Outcome|Placebo Matching RotaTeq™ (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565812|NCT00092443|O5|Outcome|RotaTeq™ at Expiry Potency (SNA - P1A)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565813|NCT00092443|O4|Outcome|RotaTeq™ at Expiry Potency (SNA - G4)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565814|NCT00092443|O3|Outcome|RotaTeq™ at Expiry Potency (SNA - G3)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565815|NCT00092443|O2|Outcome|RotaTeq™ at Expiry Potency (SNA - G2)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565816|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (SNA - G1)|Subjects tested with data available for analysis excluding protocol violators and subjects with invalid data based on lab determinations.
565817|NCT00092443|O2|Outcome|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
565910|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565911|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565818|NCT00092443|O1|Outcome|RotaTeq™ at Expiry Potency (≈1.1 x 107 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565819|NCT00092443|E2|Reported Event|Placebo Matching RotaTeq™|Placebo matching RotaTeq™ administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination and follow-up for AGEs through the first rotavirus season post vaccination.
565820|NCT00092443|E1|Reported Event|RotaTeq™ at Expiry Potency (≈1.1 x 10^7 IU/Dose)|Three doses of RotaTeq™ (Rotavirus vaccine, live, oral, pentavalent) administered 28 to 70 days apart, with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season post vaccination.
565821|NCT00092417|B3|Baseline|Total|Total of all reporting groups
565822|NCT00092417|B2|Baseline|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565823|NCT00092417|B1|Baseline|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565824|NCT00092417|P2|Participant Flow|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565825|NCT00092417|P1|Participant Flow|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565826|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565827|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565828|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565829|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565830|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565831|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565832|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565833|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565834|NCT00092417|O2|Outcome|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565835|NCT00092417|O1|Outcome|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565836|NCT00092417|E2|Reported Event|Zoster Vaccine Lower Potency|Lower potency Zoster vaccine (approximately 58,000 PFU), 1 subcutaneous 0.65 mL injection
565837|NCT00092417|E1|Reported Event|Zoster Vaccine Higher Potency|Higher potency Zoster vaccine (approximately 207,000 plaque-forming units [PFU]), 1 subcutaneous 0.65 mL injection
565838|NCT00092131|B1|Baseline|Overall Study Population|All randomized patients
565839|NCT00092131|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
565840|NCT00092131|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
565841|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565842|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565843|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565844|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565845|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565846|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565847|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565848|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565849|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565850|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565851|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565852|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565853|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565854|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565855|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565856|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565857|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565858|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565859|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565860|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565861|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565862|NCT00092131|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
565863|NCT00092131|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
565865|NCT00092131|E2|Reported Event|Placebo in Period I Then Montelukast 10 mg in Period II|A montelukast matching-image placebo tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast 10-mg tablet (Treatment Period II) was taken orally as a single witnessed dose.
565866|NCT00092131|E1|Reported Event|Montelukast 10 mg in Period I Then Placebo in Period II|A montelukast 10-mg tablet (Treatment Period I) was taken orally as a single witnessed dose followed by a 3-7 day washout. Then a montelukast matching-image placebo tablet (Treatment Period II) was taken orally as a single witnessed dose.
565867|NCT00092118|B3|Baseline|Total|Total of all reporting groups
565868|NCT00092118|B2|Baseline|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565869|NCT00092118|B1|Baseline|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565870|NCT00092118|P2|Participant Flow|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565871|NCT00092118|P1|Participant Flow|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565872|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565873|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565874|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565875|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565876|NCT00092118|O2|Outcome|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565877|NCT00092118|O1|Outcome|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565878|NCT00092118|E2|Reported Event|Montelukast 10 mg|Montelukast 10 mg tablets were taken orally once daily at bedtime for 6 weeks.
565879|NCT00092118|E1|Reported Event|Placebo|Montelukast matching-image placebo tablets were taken orally once daily at bedtime for 6 weeks.
565880|NCT00091962|B4|Baseline|Total|Total of all reporting groups
565881|NCT00091962|B3|Baseline|Non-Depressed Control|Observational only
565882|NCT00091962|B2|Baseline|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
565883|NCT00091962|B1|Baseline|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
565884|NCT00091962|P3|Participant Flow|Non-Depressed Control Group|
565885|NCT00091962|P2|Participant Flow|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
565886|NCT00091962|P1|Participant Flow|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
565887|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
565888|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
565889|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
565890|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
565891|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
565892|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
565893|NCT00091962|O3|Outcome|Non-Depressed Control Group|Non-depressed groups as Control to see the natural course of recovery after CABG
565894|NCT00091962|O2|Outcome|Depressed Usual Care|"Control group will receive usual care for depression~Usual Care: Usual care for depression"
565895|NCT00091962|O1|Outcome|Depressed Intervention|"Collaborative care program for depression involving a telephone-based nurse care manager~Counseling: Counseling program~Pharmacotherapy: Medication to treat depression"
565896|NCT00091962|O3|Outcome|Non-Depressed Control|Non-depressed control group with no intervention
565897|NCT00091962|O2|Outcome|Depressed Usual Care|"Usual care for depression by patients' PCP"
565898|NCT00091962|O1|Outcome|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
565899|NCT00091962|E3|Reported Event|Non-Depressed Control|Non-depressed control group with no intervention
565900|NCT00091962|E2|Reported Event|Depressed Usual Care|"Usual care for depression by patients' PCP"
565901|NCT00091962|E1|Reported Event|Depressed Intervention|"Telephone-based, nurse-delivered Collaborative Care program for depression; Involving: Psychoeducation; workbook for depression self-care; initiation or adjustment of antidepressant pharmacotherapy prescribed under their PCPs’ direction; referral to mental health specialist~Psychoeducation; Treatment recommendations: Counseling program~Pharmacotherapy: Medication to treat depression"
565902|NCT00091949|B3|Baseline|Total|Total of all reporting groups
565903|NCT00091949|B2|Baseline|Placebo|placebo: an inactive substance
565904|NCT00091949|B1|Baseline|Pioglitazone|pioglitazone: a thiazolidinedione drug
565905|NCT00091949|P2|Participant Flow|Placebo|placebo: an inactive substance
565906|NCT00091949|P1|Participant Flow|Pioglitazone|pioglitazone: a thiazolidinedione drug
565907|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565912|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565913|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565914|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565915|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565916|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565917|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565918|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565919|NCT00091949|O2|Outcome|Placebo|placebo: an inactive substance
565920|NCT00091949|O1|Outcome|Pioglitazone|pioglitazone: a thiazolidinedione drug
565921|NCT00091949|E2|Reported Event|Placebo|placebo: an inactive substance
565922|NCT00091949|E1|Reported Event|Pioglitazone|pioglitazone: a thiazolidinedione drug
565923|NCT00091832|B7|Baseline|Total|Total of all reporting groups
565924|NCT00091832|B6|Baseline|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565925|NCT00091832|B5|Baseline|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565926|NCT00091832|B4|Baseline|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565927|NCT00091832|B3|Baseline|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565928|NCT00091832|B2|Baseline|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565929|NCT00091832|B1|Baseline|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565930|NCT00091832|P6|Participant Flow|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565931|NCT00091832|P5|Participant Flow|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565932|NCT00091832|P4|Participant Flow|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565933|NCT00091832|P3|Participant Flow|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565934|NCT00091832|P2|Participant Flow|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565935|NCT00091832|P1|Participant Flow|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion (IV)
565936|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565937|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565938|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565939|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565940|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565941|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565942|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565943|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565944|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565945|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565946|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565947|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565948|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565949|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565950|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565951|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565952|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565953|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565954|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565955|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565956|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565957|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565958|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565959|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565960|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565961|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565962|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565963|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565964|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565965|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565966|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565967|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565968|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565969|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565970|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566329|NCT00090519|P1|Participant Flow|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
565971|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565972|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565973|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565974|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565975|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565976|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565977|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565978|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565979|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565980|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565981|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565982|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565983|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565984|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565985|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565986|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565987|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565988|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565989|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565990|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565991|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565992|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565993|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
565994|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
565995|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
565996|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
565997|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
565998|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
565999|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566000|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566001|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566002|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566003|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566004|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566005|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566006|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566007|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566008|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566009|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566010|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566011|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566012|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566013|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566014|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566015|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566016|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566017|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566018|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566019|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566020|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566021|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566022|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566023|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566024|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566025|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566026|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566027|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566028|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566029|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566030|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566031|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566032|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566033|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566034|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566035|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566036|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566037|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566038|NCT00091832|O6|Outcome|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566039|NCT00091832|O5|Outcome|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566040|NCT00091832|O4|Outcome|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566041|NCT00091832|O3|Outcome|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566042|NCT00091832|O2|Outcome|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566043|NCT00091832|O1|Outcome|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion
566044|NCT00091832|E6|Reported Event|Denosumab 180 mg Q12W|Denosumab 180 mg by subcutaneous injection every 12 weeks (Q12W)
566045|NCT00091832|E5|Reported Event|Denosumab 60 mg Q12W|Denosumab 60 mg by subcutaneous injection every 12 weeks (Q12W)
566046|NCT00091832|E4|Reported Event|Denosumab 180 mg Q4W|Denosumab 180 mg by subcutaneous injection every 4 weeks (Q4W)
566047|NCT00091832|E3|Reported Event|Denosumab 120 mg Q4W|Denosumab 120 mg by subcutaneous injection every 4 weeks (Q4W)
566048|NCT00091832|E2|Reported Event|Denosumab 30 mg Q4W|Denosumab 30 mg by subcutaneous injection every 4 weeks (Q4W)
566049|NCT00091832|E1|Reported Event|Bisphosphonate IV Q4W|Open label bisphosphonate every 4 weeks (Q4W) by intravenous infusion.
566050|NCT00091819|B3|Baseline|Total|Total of all reporting groups
566051|NCT00091819|B2|Baseline|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
566052|NCT00091819|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
566053|NCT00091819|P2|Participant Flow|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
566054|NCT00091819|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
566055|NCT00091819|O2|Outcome|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
566056|NCT00091819|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
566057|NCT00091819|E2|Reported Event|Vancomycin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive vancomycin 1 Gram every 12 hours. The maximum allowable treatment period was 14 days.
566058|NCT00091819|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections (primarily due to MRSA) were randomized to receive telavancin 10 mg/kg IV once daily. The maximum allowable treatment period was 14 days.
566059|NCT00091793|B3|Baseline|Total|Total of all reporting groups
566060|NCT00091793|B2|Baseline|Placebo|
566061|NCT00091793|B1|Baseline|Denosumab 60 mg Q6M|
566062|NCT00091793|P2|Participant Flow|Placebo|
566063|NCT00091793|P1|Participant Flow|Denosumab 60 mg Q6M|
566064|NCT00091793|O2|Outcome|Placebo|
566065|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566066|NCT00091793|O2|Outcome|Placebo|
566067|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566068|NCT00091793|O2|Outcome|Placebo|
566069|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566070|NCT00091793|O2|Outcome|Placebo|
566071|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566072|NCT00091793|O2|Outcome|Placebo|
566073|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566074|NCT00091793|O2|Outcome|Placebo|
566075|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566076|NCT00091793|O2|Outcome|Placebo|
566077|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566078|NCT00091793|O2|Outcome|Placebo|
566079|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566080|NCT00091793|O2|Outcome|Placebo|
566081|NCT00091793|O1|Outcome|Denosumab 60 mg Q6M|
566082|NCT00091793|E2|Reported Event|Denosumab 60 mg Q6M|
566083|NCT00091793|E1|Reported Event|Placebo|
566084|NCT00091572|B3|Baseline|Total|Total of all reporting groups
566085|NCT00091572|B2|Baseline|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566086|NCT00091572|B1|Baseline|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566087|NCT00091572|P2|Participant Flow|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566144|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566088|NCT00091572|P1|Participant Flow|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566089|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566090|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566091|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566092|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566093|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566094|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566095|NCT00091572|O2|Outcome|Dacarbazine|dacarbazine 1000 mg/m2 IV, on Day 1 +/- 3 days every 3 weeks
566096|NCT00091572|O1|Outcome|Temozolomide|"temozolomide 150 mg/m2/day PO, on 7 consecutive days every 14 days (7 days on / 7 days off continuously)"
566097|NCT00091572|E2|Reported Event|Dacarbazine|
566098|NCT00091572|E1|Reported Event|Temozolomide|
566099|NCT00091507|B3|Baseline|Total|Total of all reporting groups
566100|NCT00091507|B2|Baseline|Placebo|Dextrose 5%
566101|NCT00091507|B1|Baseline|GIK --|GIK = glucose-insulin-potassium
566102|NCT00091507|P2|Participant Flow|Placebo|Dextrose 5%
566103|NCT00091507|P1|Participant Flow|GIK --|GIK = glucose-insulin-potassium
566104|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
566105|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
566106|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
566107|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
566108|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
566109|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
566110|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
566111|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
566112|NCT00091507|O2|Outcome|Placebo|Dextrose 5%
566113|NCT00091507|O1|Outcome|GIK --|GIK = glucose-insulin-potassium
566114|NCT00091507|E2|Reported Event|Placebo|Dextrose 5%
566115|NCT00091507|E1|Reported Event|GIK --|GIK = glucose-insulin-potassium
566116|NCT00091442|B3|Baseline|Total|Total of all reporting groups
566117|NCT00091442|B2|Baseline|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566118|NCT00091442|B1|Baseline|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566119|NCT00091442|P2|Participant Flow|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566120|NCT00091442|P1|Participant Flow|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566121|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566122|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566123|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566124|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566125|NCT00091442|O2|Outcome|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566126|NCT00091442|O1|Outcome|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566127|NCT00091442|E2|Reported Event|DOXIL+Docetaxel|DOXIL and docetaxel combination: DOXIL 30 mg/m2 solution administered by intravenous infusion, followed by docetaxel 60 mg/m2 administration by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566128|NCT00091442|E1|Reported Event|Docetaxel|Docetaxel monotherapy: Docetaxel 75 mg/m2 solution administered by intravenous infusion over 1 hour on Day 1 of every 21-day cycle.
566129|NCT00091390|B1|Baseline|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
566130|NCT00091390|P1|Participant Flow|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
566131|NCT00091390|O1|Outcome|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
566132|NCT00091390|E1|Reported Event|EBRT and HDR Brachytherapy Boost|External beam radiation therapy (EBRT) and high dose rate (HDR) brachytherapy boost.
566133|NCT00091273|B1|Baseline|Single Arm|
566134|NCT00091273|P1|Participant Flow|Single Arm|
566135|NCT00091273|O1|Outcome|Single Arm|
566136|NCT00091273|O1|Outcome|Single Arm|
566137|NCT00091273|O1|Outcome|Single Arm|
566138|NCT00091273|E1|Reported Event|Single Arm|
566139|NCT00091169|B3|Baseline|Total|Total of all reporting groups
566140|NCT00091169|B2|Baseline|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566141|NCT00091169|B1|Baseline|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566142|NCT00091169|P2|Participant Flow|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566143|NCT00091169|P1|Participant Flow|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566145|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566146|NCT00091169|O2|Outcome|Arm II|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566147|NCT00091169|O1|Outcome|Arm I|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566148|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566149|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566150|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566151|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566152|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566153|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566154|NCT00091169|O2|Outcome|Placebo|"Patients receive oral placebo twice daily on weeks 1-4.~placebo: Given orally"
566155|NCT00091169|O1|Outcome|Levocarnitine|"Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4.~levocarnitine: Given orally"
566156|NCT00091169|E2|Reported Event|Placebo|Patients receive oral placebo twice daily on weeks 1-4. placebo: Given orally
566157|NCT00091169|E1|Reported Event|Levocarnitine|Patients receive oral levocarnitine (L-carnitine) twice daily on weeks 1-4. levocarnitine: Given orally
566158|NCT00091026|B3|Baseline|Total|Total of all reporting groups
566159|NCT00091026|B2|Baseline|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566160|NCT00091026|B1|Baseline|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566161|NCT00091026|P2|Participant Flow|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566162|NCT00091026|P1|Participant Flow|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566163|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566164|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566165|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566166|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566167|NCT00091026|O2|Outcome|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566168|NCT00091026|O1|Outcome|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566169|NCT00091026|E2|Reported Event|Arm II (Gemcitabine Hydrochloride, Bevacizumab, Erlotinib)|Patients receive gemcitabine and bevacizumab as in arm I. Patients also receive oral erlotinib once daily on days 1-5, 8-12, and 15-26.
566170|NCT00091026|E1|Reported Event|Arm I (Cetuximab, Gemcitabine Hydrochloride, Bevacizumab)|Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, and 22; gemcitabine IV over 30 minutes on days 1, 8, and 15; and bevacizumab IV over 30-90 minutes on days 1 and 15.
566171|NCT00090987|B1|Baseline|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
566172|NCT00090987|P1|Participant Flow|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
566173|NCT00090987|O1|Outcome|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
566174|NCT00090987|E1|Reported Event|Imatinib Mesylate (Gleevec)|Imatinib mesylate (Gleevec) is administered 400 mg orally once a day
566175|NCT00090844|B3|Baseline|Total|Total of all reporting groups
566176|NCT00090844|B2|Baseline|no Triptorelin|no GnRH analogue (triptorelin) during chemotherapy
566177|NCT00090844|B1|Baseline|Triptorelin|GnRH analogue (triptorelin) during chemotherapy
566178|NCT00090844|P2|Participant Flow|no Triptorelin|No Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy
566179|NCT00090844|P1|Participant Flow|Triptorelin|"Gonadotropin-releasing hormone [GnRH] analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
566180|NCT00090844|O2|Outcome|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
566181|NCT00090844|O1|Outcome|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
566182|NCT00090844|E2|Reported Event|no Triptorelin|No GnRH analogue (triptorelin) during chemotherapy
566183|NCT00090844|E1|Reported Event|Triptorelin|"GnRH analogue (triptorelin) during chemotherapy~triptorelin : 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection"
566184|NCT00090779|B3|Baseline|Total|Total of all reporting groups
566185|NCT00090779|B2|Baseline|DT Arm|DT arm participants received no Treatment
566186|NCT00090779|B1|Baseline|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566187|NCT00090779|P2|Participant Flow|DT Arm|On step 1, DT arm participants received no Treatment,unless subsequent disease progression criteria were met. Participants in DT arm who met clinical, virologic or immunologic criteria for treatment initiation entered step 2 and initiated ART. At the time of the end of original randomized study, study participants in DT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
566188|NCT00090779|P1|Participant Flow|IT Arm|On step 1, IT arm participants received 36 weeks of emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily. Participants in IT arm who met clinical, virologic or immunologic criteria for treatment re-initiation entered step 2 and re-initiated ART. At the time of the end of original randomized study, study participants in IT arm who did not enter Step 2 and did not initiate ART without meeting eligibility criteria for Step 2 had the opportunity to take part in a long-term follow-up study (step 3) for up to a total duration of five years in order to ascertain information about HIV-1 RNA, CD4+ T-cell count, occurrence of CDC Category B or C diagnoses, and initiation of ART.
566189|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566190|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566191|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566192|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566193|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566194|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566195|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566196|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566197|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566198|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566199|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566200|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566201|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566202|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566203|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566204|NCT00090779|O2|Outcome|DT Arm|DT arm participants received no Treatment
566205|NCT00090779|O1|Outcome|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566206|NCT00090779|E2|Reported Event|DT Arm|DT arm participants received no Treatment
566207|NCT00090779|E1|Reported Event|IT Arm|IT arm participants received emtricitabine/tenofovir disoproxil fumarate once daily and lopinavir/ritonavir twice daily
566208|NCT00090766|B4|Baseline|Total|Total of all reporting groups
566209|NCT00090766|B3|Baseline|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566210|NCT00090766|B2|Baseline|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566211|NCT00090766|B1|Baseline|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566212|NCT00090766|P3|Participant Flow|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566213|NCT00090766|P2|Participant Flow|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566214|NCT00090766|P1|Participant Flow|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 milligrams (mg) once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * body surface area [BSA] * creatinine clearance [CrCLS]).
566215|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566216|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566217|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566281|NCT00090584|B3|Baseline|Total|Total of all reporting groups
566330|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566218|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566219|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566220|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566221|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566222|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566223|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566224|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566225|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566226|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566227|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566228|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566229|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566230|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566231|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566232|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566233|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566234|NCT00090766|O1|Outcome|Overall Study|All participants who received at least one dose of valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566235|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566236|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566237|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566238|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566239|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566240|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566241|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566242|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566243|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566244|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Participants aged >= 12 years received a once daily oral dose (solution or tablets) of valganciclovir from the time of kidney transplant for up to 100 days post-transplant. Dose (in mg) was calculated using the algorithm (7 * body surface area * creatinine clearance).
566245|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566246|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566247|NCT00090766|O3|Outcome|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566248|NCT00090766|O2|Outcome|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566249|NCT00090766|O1|Outcome|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566250|NCT00090766|E3|Reported Event|Valganciclovir Age Group >= 12 Years|Eligible participants aged >= 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566251|NCT00090766|E2|Reported Event|Valganciclovir Age Group >2 to < 12 Years|Eligible participants aged >2 to < 12 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566252|NCT00090766|E1|Reported Event|Valganciclovir Age Group <= 2 Years|Eligible participants aged <= 2 years received valganciclovir up to maximum of 900 mg once daily oral dose (solution or tablets) from the time of kidney transplantation for up to 100 days post-transplant. Dose was calculated using the algorithm (7 * BSA * CrCLS).
566253|NCT00090753|B3|Baseline|Total|Total of all reporting groups
566254|NCT00090753|B2|Baseline|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
566255|NCT00090753|B1|Baseline|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
566256|NCT00090753|P2|Participant Flow|Comparator ESA|Patients received the same comparator erythropoiesis stimulating agent (ESA) [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
566257|NCT00090753|P1|Participant Flow|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta (Mircera) via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
566282|NCT00090584|B2|Baseline|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566283|NCT00090584|B1|Baseline|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566331|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566258|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
566259|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
566260|NCT00090753|O2|Outcome|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
566261|NCT00090753|O1|Outcome|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
566262|NCT00090753|E2|Reported Event|Comparator ESA|Patients received the same comparator ESA [epoetin alfa, epoetin beta, or darbepoetin alfa] at the same weekly dose and dosing interval via the same route of administration (iv or sc) as they received in the Phase III study that qualified the patient for participation in this study. The dose of the comparator drug was adjusted to maintain the patient's Hb within a target range of 11 to 13 g/dL. Of the 480 patients in the comparator drug group, 170 received darbepoetin alfa, 134 received epoetin alfa, and 176 received epoetin beta.
566263|NCT00090753|E1|Reported Event|Methoxy Polyethylene Glycol-Epoetin Beta|Patients received the same weekly dose of methoxy polyethylene glycol-epoetin beta via the same route of administration (iv or sc) as they received in the Phase II or Phase III study that qualified the patient for participation in this study. Methoxy polyethylene glycol-epoetin beta was administered every 2 or every 4 weeks in the initial 104-week treatment period. Patients on a 4-week dosing interval were switched to once-monthly administration in the 24-month extension phase. The dose of methoxy polyethylene glycol-epoetin beta was adjusted to maintain the patient's hemoglobin (Hb) within a target range of 11 to 13 g/dL.
566264|NCT00090610|B3|Baseline|Total|Total of all reporting groups
566265|NCT00090610|B2|Baseline|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566266|NCT00090610|B1|Baseline|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566267|NCT00090610|P2|Participant Flow|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566268|NCT00090610|P1|Participant Flow|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566269|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566270|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566271|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566272|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566273|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566274|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566275|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566276|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566277|NCT00090610|O2|Outcome|Arm 2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566278|NCT00090610|O1|Outcome|Arm 1|Docetaxel 30mg/m2 mg IV on Days 1 and 8, combined with carboplatin AUC 6 IV on Day 1, repeated every 21 days X 6 cycles or until disease progression
566279|NCT00090610|E2|Reported Event|Arm2|Docetaxel 30mg/m2 IV on Days 1 and 8, repeated every 21 days for 6 cycles until disease progression, followed by carboplatin AUC 6 IV every 21 days for 6 cycles or until disease progression.
566280|NCT00090610|E1|Reported Event|Arm 1|Docetaxel 30 mg/m2 intravenously (IV) on Days 1 and 8, combined with carboplatin area under the concentration versus time curve (AUC) 6 IV on Day 1, repeated every 21 days for 6 cycles or until disease progression (DP) (whichever occurred first).
566284|NCT00090584|P2|Participant Flow|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566285|NCT00090584|P1|Participant Flow|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566286|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566287|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566288|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566289|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566290|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566291|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566292|NCT00090584|O2|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
566293|NCT00090584|O1|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
566294|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
566295|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
566296|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
566297|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
566298|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
566299|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
566300|NCT00090584|O6|Outcome|Drug Only at 8 Months|8 month value for women randomized to drug only
566301|NCT00090584|O5|Outcome|Drug Only at 10 Weeks|10 week value for women randomized to drug only
566302|NCT00090584|O4|Outcome|Drug Only at Baseline|Baseline value for women randomized to drug only
566303|NCT00090584|O3|Outcome|Combiniation at 8 Months|8 months value from women in combination arm
566304|NCT00090584|O2|Outcome|Combination at 10 Weeks|10 week value for women in combination arm
566305|NCT00090584|O1|Outcome|Combination at Baseline|Baseline value for women in combination therapy
566306|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566307|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566308|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566309|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566310|NCT00090584|O2|Outcome|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566311|NCT00090584|O1|Outcome|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566312|NCT00090584|E2|Reported Event|Drug Therapy Alone|Women assigned to this arm received 10 weeks of anti-cholinergic medication, only.
566313|NCT00090584|E1|Reported Event|Combination Therapy|Women randomly assigned to this condition receive 10 weeks of anti-cholinergic medication and behavioral training.
566314|NCT00090545|B3|Baseline|Total|Total of all reporting groups
566315|NCT00090545|B2|Baseline|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles"
566316|NCT00090545|B1|Baseline|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566317|NCT00090545|P2|Participant Flow|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566318|NCT00090545|P1|Participant Flow|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566319|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566320|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566321|NCT00090545|O2|Outcome|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566322|NCT00090545|O1|Outcome|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566323|NCT00090545|E2|Reported Event|Second Stage - Increased Accrual|"Due to prostatic specific antigen and radiographic discordance during the first stage, the protocol was amended to allow accrual to a second stage.~400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566324|NCT00090545|E1|Reported Event|First Stage - Disease Progression|"The first stage was to rule out the probability of 4 month progression free survival.~Patients were given 400 mg BAY 43-9006 orally twice daily in 28 day cycles."
566325|NCT00090519|B3|Baseline|Total|Total of all reporting groups
566326|NCT00090519|B2|Baseline|Placebo|QD oral for up to 36 months
566327|NCT00090519|B1|Baseline|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566328|NCT00090519|P2|Participant Flow|Placebo|QD oral for up to 36 months
566332|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566333|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566334|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566335|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566336|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566337|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566338|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566339|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566340|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566341|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566342|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566343|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566344|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566345|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566346|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566347|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566348|NCT00090519|O2|Outcome|Placebo|QD oral for up to 36 months
566349|NCT00090519|O1|Outcome|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566350|NCT00090519|E2|Reported Event|Placebo|QD oral for up to 36 months
566351|NCT00090519|E1|Reported Event|Ruboxistaurin|32 mg once daily (QD) oral for up to 36 months
566352|NCT00090493|B1|Baseline|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|Treatment will consist of receiving peptide (small pieces of proteins) vaccinations as a shot just under the skin (subcutaneous). Purpose is to generate anti-myeloma T-cells with will kill only myeloma cells. Three injections of peptide will be given subcutaneously together with the adjuvant GM-CSF at 2-week intervals.
566353|NCT00090493|P1|Participant Flow|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
566354|NCT00090493|O1|Outcome|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
566355|NCT00090493|E1|Reported Event|MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY|"Treatment will consist of receiving peptide (small pieces of proteins)vaccinations as a shot just under the skin (subcutaneous). We have chosen to vaccinate with peptides derived from cancer proteins found in myeloma and other cancers. Purpose: to generate anti-myeloma T-cells which will kill only myeloma cells.~MAGE-A3 AND NY-ESO-1 IMMUNOTHERAPY : 3 injections with 300µg/injection (in 1.5mls) of peptide will be given subcutaneously together with the adjuvant GM-CSF at 500µg (same site in 0.5 mls) at two-week intervals.~MAGE-A3 : vaccinations at 2-week intervals (days 22,36,50) with the MAGE-A3 or NY-ESO-1 peptide and GM-CSF adjuvant. The peptides will be given s.c. in a dose of 300μg; GM-CSF (250μg) will be administered to promote attraction, maturation and longevity of DCs. #2 will be thawed and re-infused after transplant on day 81 and any anti-myeloma T-cells in this leukapheresis product will be boosted immediately by re-vaccinating."
566356|NCT00090402|B4|Baseline|Total|Total of all reporting groups
566357|NCT00090402|B3|Baseline|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
566358|NCT00090402|B2|Baseline|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
566359|NCT00090402|B1|Baseline|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
566360|NCT00090402|P3|Participant Flow|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
566361|NCT00090402|P2|Participant Flow|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
566362|NCT00090402|P1|Participant Flow|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
566363|NCT00090402|O3|Outcome|Fish Oil Plus Lipoic Acid|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanioic acid and 975 mg eicosapentanoic acid plus alpha lipoic acid (racemic) daily dose 600 mg taken for 12 months.
566364|NCT00090402|O2|Outcome|Fish Oil|Fish oil concnetrate, daily dose 3 grams per day containing 675 mg docosahexanoic acid and 975 mg eicosapentanoic acid, taken for 12 months.
566365|NCT00090402|O1|Outcome|Placebo|Placebo oil (soybean oil), daily dose 3 grams taken for 12 months
566366|NCT00090402|E3|Reported Event|Fish Oil Plus Lipoic Acid|
566367|NCT00090402|E2|Reported Event|Fish Oil|
566368|NCT00090402|E1|Reported Event|Placebo|
566369|NCT00090363|B4|Baseline|Total|Total of all reporting groups
566370|NCT00090363|B3|Baseline|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566371|NCT00090363|B2|Baseline|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566372|NCT00090363|B1|Baseline|Placebo|Matching placebo oral tablet once daily, with best supportive care
566373|NCT00090363|P3|Participant Flow|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566374|NCT00090363|P2|Participant Flow|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566375|NCT00090363|P1|Participant Flow|Placebo|Matching placebo oral tablet once daily, with best supportive care
566376|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566377|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566378|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
566379|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566380|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566381|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
566382|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566383|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566384|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
566385|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566386|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566387|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
566388|NCT00090363|O3|Outcome|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566389|NCT00090363|O2|Outcome|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566390|NCT00090363|O1|Outcome|Placebo|Matching placebo oral tablet once daily, with best supportive care
566391|NCT00090363|E3|Reported Event|ZD4054 15 mg|ZD4054 15 mg oral tablet once daily, with best supportive care
566392|NCT00090363|E2|Reported Event|ZD4054 10 mg|ZD4054 10 mg oral tablet once daily, with best supportive care
566393|NCT00090363|E1|Reported Event|Placebo|Matching placebo oral tablet once daily, with best supportive care
566394|NCT00090285|B3|Baseline|Total|Total of all reporting groups
566395|NCT00090285|B2|Baseline|Placebo|Participants who started the base study vaccination period
566396|NCT00090285|B1|Baseline|qHPV Vaccine|Participants who started the base study vaccination period
566397|NCT00090285|P4|Participant Flow|EXT1: Incomplete qHPV Regimen in Base Study|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7.
566398|NCT00090285|P3|Participant Flow|EXT1: Placebo in Base Study|Participants in the placebo arm in the base study were offered 3 doses of open-label qHPV vaccine at EXT1 Day 1, Month 2 and Month 6. Participants were followed to EXT1 Month 7.
566399|NCT00090285|P2|Participant Flow|Placebo in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36."
566400|NCT00090285|P1|Participant Flow|qHPV Vaccine in Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36."
566401|NCT00090285|O2|Outcome|Placebo: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
566402|NCT00090285|O1|Outcome|qHPV Vaccine: Base Study and Followup|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
566403|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566404|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566405|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566406|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566407|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566408|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566409|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566410|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566411|NCT00090285|O2|Outcome|Placebo|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566412|NCT00090285|O1|Outcome|qHPV Vaccine|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. Not all participants reached Month 36 prior to the cut-off for the pre-specified analysis."
566413|NCT00090285|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo and participants who received only 1 dose of qHPV vaccine in the base study were offered a complete 3-dose qHPV vaccine regimen (administered at EXT1 Day 1, Month 2 and Month 6). Participants who received only 2 doses of qHPV vaccine in the base study were offered a single additional dose of qHPV vaccine (administered at EXT1 Day 1). Participants were followed to EXT1 Month 7. The at-risk population was participants who received ≥ 1 qHPV vaccination in EXT1 and had follow-up data.
566414|NCT00090285|E2|Reported Event|Placebo: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received placebo at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 placebo injection in the base study."
566415|NCT00090285|E1|Reported Event|qHPV Vaccine: Base Study|"The Vaccination Period for the base study encompassed Day 1 through Month 7, during which time participants received qHPV vaccination at Day 1, Month 2 and Month 6.~Follow-up for the base study encompassed Month 7 through Month 36. The at-risk population was participants who received ≥ 1 qHPV vaccination in the base study."
566416|NCT00090259|B3|Baseline|Total|Total of all reporting groups
566417|NCT00090259|B2|Baseline|Losartan 150 mg|
566418|NCT00090259|B1|Baseline|Losartan 50 mg|
566419|NCT00090259|P2|Participant Flow|Losartan 150 mg|
566420|NCT00090259|P1|Participant Flow|Losartan 50 mg|
566421|NCT00090259|O2|Outcome|Losartan 150 mg|
566422|NCT00090259|O1|Outcome|Losartan 50 mg|
566423|NCT00090259|O2|Outcome|Losartan 150 mg|
566424|NCT00090259|O1|Outcome|Losartan 50 mg|
566425|NCT00090259|O2|Outcome|Losartan 150 mg|
566426|NCT00090259|O1|Outcome|Losartan 50 mg|
566427|NCT00090259|O2|Outcome|Losartan 150 mg|
566428|NCT00090259|O1|Outcome|Losartan 50 mg|
566429|NCT00090259|O2|Outcome|Losartan 150 mg|
566430|NCT00090259|O1|Outcome|Losartan 50 mg|
566431|NCT00090259|E2|Reported Event|Losartan 150 mg|
566432|NCT00090259|E1|Reported Event|Losartan 50 mg|
566433|NCT00090233|B3|Baseline|Total|Total of all reporting groups
566434|NCT00090233|B2|Baseline|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566435|NCT00090233|B1|Baseline|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566436|NCT00090233|P2|Participant Flow|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
566437|NCT00090233|P1|Participant Flow|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart with up to 42 days of safety follow-up after each vaccination, and follow-up for acute gastrointestinal episodes (AGEs) through the first rotavirus season postvaccination. The rotavirus season for each site was prospectively determined using historical epidemiologic data.
566438|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566439|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566440|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566441|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566442|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566443|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566444|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566445|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566446|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566447|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566448|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566449|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566450|NCT00090233|O2|Outcome|Placebo|The number of participants randomized to treatment with Placebo is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
566451|NCT00090233|O1|Outcome|RotaTeq™|The number of participants randomized to treatment with RotaTeq™ is different from the number analyzed because some participants were excluded due to protocol violations and/or participants without follow-up and/or participants classified as unevaluable due to detection of wildtype rotavirus in the stool prior to 14 days Postdose 3; incomplete clinical and/or laboratory results; or stool samples collected out of day range.
566452|NCT00090233|O2|Outcome|Placebo|Participants randomized to treatment with Placebo tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
566453|NCT00090233|O1|Outcome|RotaTeq™|Participants randomized to treatment with RotaTeq™ tested with data available for analysis excluding protocol violators, participants with invalid data based on laboratory determinations, participants with wildtype rotavirus detected in the stool, or with samples taken outside the range of 9 to 33 days postdose 3.
566454|NCT00090233|O2|Outcome|Placebo|Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566455|NCT00090233|O1|Outcome|RotaTeq™|Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.
566456|NCT00090233|E2|Reported Event|Placebo|"Placebo matching RotaTeq™ administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
566457|NCT00090233|E1|Reported Event|RotaTeq™|"Three oral doses (~6.5x10^7 to ~1.2x10^8 IU/dose) of RotaTeq™ (rotavirus vaccine, live, oral, pentavalent) administered at 3 separate visits scheduled 4 to 10 weeks (28 to 70 days) apart.~The Not Completed total includes participants discontinued at any time before the completion of the third study vaccination and/or the 42-day safety follow-up period post vaccination 3."
566458|NCT00090220|B3|Baseline|Total|Total of all reporting groups
566459|NCT00090220|B2|Baseline|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566460|NCT00090220|B1|Baseline|qHPV Vaccine in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566461|NCT00090220|P6|Participant Flow|Placebo in Base Study and qHPV Vaccine in EXT1: LTFU (EXT2)|Participants at sites in Colombia who received placebo or an incomplete regimen of qHPV in the Base Study and open-label qHPV in EXT1 were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study.
566462|NCT00090220|P5|Participant Flow|qHPV Vaccine in Base Study: LTFU (EXT2)|Participants at sites in Colombia who received qHPV vaccination in the Base Study were followed from approximately Month 72 up to Month 120 (Year 10) after Day 1 in the Base Study
566463|NCT00090220|P4|Participant Flow|Incomplete qHPV Regimen in Base Study: EXT1|Participants who received an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine beginning at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study) and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
566464|NCT00090220|P3|Participant Flow|Placebo in Base Study: EXT1|Participants who received placebo in the Base Study were offered open-label qHPV vaccine at EXT1 Day 1 (approximately 60 months after Day 1 of the Base Study), Month 2, and Month 6 and were followed to EXT1 Month 7 (approximately 67 months after Day 1 of the Base Study)
566465|NCT00090220|P2|Participant Flow|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6
566466|NCT00090220|P1|Participant Flow|qHPV Vaccine in Base Study|Participants received Quadrivalent Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine (qHPV, Gardasil) at Day 1, Month 2, and Month 6
566467|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566468|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566469|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566470|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566471|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566472|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566473|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566474|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566475|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
566476|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566477|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
566478|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566479|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566480|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566481|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566482|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566483|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566484|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566485|NCT00090220|O2|Outcome|Placebo in the Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566486|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566487|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
566488|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566489|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566490|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566491|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566492|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566493|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566494|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566495|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566496|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566497|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566498|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566499|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566500|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566501|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566502|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566503|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566504|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566505|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566506|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566507|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566508|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566509|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566510|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566511|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566512|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566513|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566514|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566515|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566516|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566517|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566518|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566519|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566520|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 35 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566521|NCT00090220|O1|Outcome|qHPV in Base Study: Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566522|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566523|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566524|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566525|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566526|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566527|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566528|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566529|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566530|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566531|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566532|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566533|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566534|NCT00090220|O3|Outcome|qHPV in Base Study: Participants 35 to 45 Years Old|35 to 45 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566535|NCT00090220|O2|Outcome|qHPV in Base Study: Participants 24 to 34 Years Old|24 to 34 year-old participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566536|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566537|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566538|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566539|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566540|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566541|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566542|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566543|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566544|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566545|NCT00090220|O2|Outcome|Base Study: Placebo|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
566546|NCT00090220|O1|Outcome|qHPV in Base Study: All Participants|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566547|NCT00090220|O2|Outcome|Placebo in Base Study|Participants who received placebo or an incomplete qHPV regimen in the Base Study and were offered open-label qHPV vaccine starting at approximately Month 60 in EXT1
566548|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566549|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed to Month 48 in the Base Study
566550|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566551|NCT00090220|O2|Outcome|Placebo in Base Study|Participants received placebo at Day 1, Month 2, and Month 6 in the Base Study
566552|NCT00090220|O1|Outcome|qHPV in Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 in the Base Study
566553|NCT00090220|E4|Reported Event|Long-term Follow-up: EXT2|Participants at sites in Colombia who received qHPV vaccination in the Base Study or in EXT1 were followed from Month 72 up to approximately Month 120 in LTFU (EXT2)
566554|NCT00090220|E3|Reported Event|qHPV Vaccine: EXT1|Participants who received placebo or an incomplete regimen of qHPV in the Base Study were offered open-label qHPV vaccine starting at approximately Month 60 (EXT1) and were followed up to Month 67
566555|NCT00090220|E2|Reported Event|Placebo: Base Study|Participants received placebo at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
566556|NCT00090220|E1|Reported Event|qHPV Vaccine: Base Study|Participants received qHPV vaccination at Day 1, Month 2, and Month 6 and were followed up to approximately Month 48
566557|NCT00090142|B1|Baseline|Overall Study Population|All randomized patients
566558|NCT00090142|P2|Participant Flow|Placebo in Period I Then Montelukast 10 mg in Period II|"A montelukast matching-image placebo tablet (Treatment Period I) was taken~orally in the morning as a single witnessed dose. This was followed by a 3-7 day washout and then a~montelukast 10-mg tablet (Treatment Period II) was taken orally in the morning as a single witnessed dose."
566559|NCT00090142|P1|Participant Flow|Montelukast 10 mg in Period I Then Placebo in Period II|"A montelukast 10-mg tablet (Treatment Period I) was taken orally in the~morning as a single witnessed dose. This was followed by a 3-7 day washout period and then a montelukast~matching-image placebo tablet (Treatment Period II) was taken orally in the morning as a single witnessed~dose."
566560|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566561|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566562|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566563|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566564|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566565|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566566|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566567|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566568|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566569|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566570|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566571|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566572|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566573|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566574|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566575|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566576|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566577|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566578|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566579|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566580|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566581|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566582|NCT00090142|O2|Outcome|Montelukast 10 mg|All Montelukast 10 mg patients from Treatment Periods I and II
566583|NCT00090142|O1|Outcome|Placebo|All Placebo patients from Treatment Periods I and II
566584|NCT00090142|E2|Reported Event|Placebo|
566585|NCT00090142|E1|Reported Event|Montelukast 10 mg|
566586|NCT00090103|B4|Baseline|Total|Total of all reporting groups
566587|NCT00090103|B3|Baseline|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566588|NCT00090103|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566589|NCT00090103|B1|Baseline|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566590|NCT00090103|P3|Participant Flow|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566591|NCT00090103|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566592|NCT00090103|P1|Participant Flow|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566593|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566594|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566595|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566596|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566597|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566598|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566599|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566600|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566601|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566602|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566603|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566604|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566605|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566606|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566607|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566608|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566609|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566610|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566611|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566612|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566613|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566614|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566615|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566616|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566617|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566618|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566619|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566620|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566621|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566622|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566623|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566624|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566625|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566626|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566627|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566628|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566629|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566630|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566631|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566632|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566633|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566634|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566635|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566636|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566637|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566638|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566639|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566640|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566641|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566642|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566643|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566644|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566645|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566646|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566647|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566648|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566649|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566650|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566651|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566652|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566653|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566654|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566655|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566656|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566657|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566658|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566659|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566660|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566661|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566662|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566663|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566664|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566665|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566666|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566667|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566668|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566669|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566670|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566671|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566672|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566673|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566674|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566675|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566676|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566677|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566678|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566679|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566680|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566681|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566682|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566683|NCT00090103|O3|Outcome|Tamsulosin 0.4 mg|Tamsulosin 0.4 mg plus dutasteride placebo once daily for 208 weeks
566684|NCT00090103|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 mg plus tamsulosin placebo once daily for 208 weeks
566685|NCT00090103|O1|Outcome|Dutasteride 0.5 mg Plus Tamsulosin 0.4 mg|Dutasteride 0.5 milligrams (mg) plus tamsulosin 0.4 mg once daily for 208 weeks
566686|NCT00090103|E3|Reported Event|Tamsulosin 0.4 mg|
566687|NCT00090103|E2|Reported Event|Dutasteride 0.5 mg|
566688|NCT00090103|E1|Reported Event|Combination|
566689|NCT00090051|B3|Baseline|Total|Total of all reporting groups
566690|NCT00090051|B2|Baseline|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566691|NCT00090051|B1|Baseline|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566692|NCT00090051|P2|Participant Flow|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566693|NCT00090051|P1|Participant Flow|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566694|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566695|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566696|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566697|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566698|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566699|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566700|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566701|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566702|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566703|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566704|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566705|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566706|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566707|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566708|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566709|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566710|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566711|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566712|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566713|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566714|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566715|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566716|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566717|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566718|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566719|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566720|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566721|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566722|NCT00090051|O2|Outcome|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566771|NCT00089843|O2|Outcome|Testosterone|Testosterone, initial dose 150 mcg transdermal daily, increased to 300 mcg daily in women with free testosterone levels below the median (n=25 women)
566723|NCT00090051|O1|Outcome|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566724|NCT00090051|E2|Reported Event|Fludarabine+Cyclophosphamide+Rituximab (FCR)|Rituximab and FC intravenously for a total of 6 treatment cycles at intervals of 28 days. Cycle 1: rituximab 375 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 2, 3, 4; cyclophosphamide 250 mg/m² IV on Days 2, 3, 4. Cycles 2-6: rituximab 500 mg/m² IV on Day 1; fludarabine 25 mg/m² IV on Days 1, 2, 3; cyclophosphamide 250 mg/m² IV on Days 1, 2, 3.
566725|NCT00090051|E1|Reported Event|Fludarabine+Cyclophosphamide (FC)|Fludarabine+cyclophosphamide (FC) intravenously for a total of 6 treatment cycles at intervals of 28 days. Fludarabine: 25 mg/m² IV on Days 1, 2, 3 for 6 cycles. Cyclophosphamide: 250 mg/m² IV on Days 1, 2, 3 for 6 cycles.
566726|NCT00089999|B3|Baseline|Total|Total of all reporting groups
566727|NCT00089999|B2|Baseline|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566728|NCT00089999|B1|Baseline|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566729|NCT00089999|P2|Participant Flow|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally twice daily (BID). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566730|NCT00089999|P1|Participant Flow|Lapatinib 1500 mg QD|Participants received lapatinib 1500 milligram (mg) orally once daily (QD). Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566731|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566732|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566733|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566734|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566735|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566736|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566737|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566738|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566739|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566740|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566741|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566844|NCT00089661|O2|Outcome|Placebo|
566742|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566743|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566744|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566745|NCT00089999|O2|Outcome|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566746|NCT00089999|O1|Outcome|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566747|NCT00089999|E2|Reported Event|Lapatinib 500 mg BID|Participants received lapatinib 500 mg orally BID. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566748|NCT00089999|E1|Reported Event|Lapatinib 1500 mg QD|Participants received lapatinib 1500 mg orally QD. Treatment was continued for 12 weeks or until disease progression or withdrawal from treatment for another reason. After Week 12, participants with clinical benefit had the option to continue with the lapatinib therapy at the same dose and schedule, until disease progression, provided the treatment was tolerated.
566749|NCT00089895|B3|Baseline|Total|Total of all reporting groups
566750|NCT00089895|B2|Baseline|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566751|NCT00089895|B1|Baseline|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566752|NCT00089895|P2|Participant Flow|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566753|NCT00089895|P1|Participant Flow|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566754|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566755|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566756|NCT00089895|O2|Outcome|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566757|NCT00089895|O1|Outcome|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566758|NCT00089895|E2|Reported Event|Placebo|Placebo in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566759|NCT00089895|E1|Reported Event|Eptifibatide|Eptifibatide in addition to standard of care which includes usage of aspirin, unfractionated heparin or low-molecular weight heparin.
566760|NCT00089843|B5|Baseline|Total|Total of all reporting groups
566761|NCT00089843|B4|Baseline|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
566762|NCT00089843|B3|Baseline|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
566763|NCT00089843|B2|Baseline|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566764|NCT00089843|B1|Baseline|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566765|NCT00089843|P4|Participant Flow|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
566766|NCT00089843|P3|Participant Flow|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
566767|NCT00089843|P2|Participant Flow|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566768|NCT00089843|P1|Participant Flow|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566769|NCT00089843|O2|Outcome|Testosterone|Testosterone patch(starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566770|NCT00089843|O1|Outcome|Actonel (Risedronate)|Actonel (risedronate) 35 mg tablet weekly
566845|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566772|NCT00089843|O1|Outcome|Actonel (Risedronate) 35 mg Weekly|Actonel (risedronate) 35 mg, 1 tablet weekly
566773|NCT00089843|E4|Reported Event|Placebo Testosterone Patch and Placebo Actonel|Placebo Testosterone Patch and placebo Actonel tablet
566774|NCT00089843|E3|Reported Event|Active Actonel and Placebo Testosterone|Active Actonel tablet (35 mg weekly) and Placebo Testosterone Patch
566775|NCT00089843|E2|Reported Event|Active Actonel and Active Testosterone Patch|Active Actonel tablet (35 mg weekly) and Active Testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566776|NCT00089843|E1|Reported Event|Placebo Actonel and Active Testosterone Patch|Placebo Actonel tablet weekly and active testosterone patch (starting dose 150 mcg daily; increased to 300 mcg daily in subjects whose levels remained below the median on the initial dose)
566777|NCT00089791|B3|Baseline|Total|Total of all reporting groups
566778|NCT00089791|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566779|NCT00089791|B1|Baseline|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566780|NCT00089791|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566781|NCT00089791|P1|Participant Flow|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566782|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566783|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566784|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566785|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566786|NCT00089791|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566787|NCT00089791|O1|Outcome|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566788|NCT00089791|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneously once every 6 months (Q6M) for 3 years.
566789|NCT00089791|E1|Reported Event|Placebo|Placebo administered subcutaneously once every 6 months for 3 years.
566790|NCT00089778|B4|Baseline|Total|Total of all reporting groups
566791|NCT00089778|B3|Baseline|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
566792|NCT00089778|B2|Baseline|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
566793|NCT00089778|B1|Baseline|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
566794|NCT00089778|P3|Participant Flow|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
566795|NCT00089778|P2|Participant Flow|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses).~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
566796|NCT00089778|P1|Participant Flow|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~This is not a conventional crossover—If a patient in Group C has a recurrence after vaccination or cancer progresses in Group A, then we wanted to administer an approved, conventional therapy for recurrent disease (IL-2) which could have had synergy with the prior experimental vaccination. This was only exploratory and there was no specific endpoint targeted in patient’s crossing over and there was no impact on study size (too involved for the scope of this study)."
566797|NCT00089778|O1|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
566798|NCT00089778|O3|Outcome|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
566846|NCT00089661|O2|Outcome|Placebo|
566847|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566848|NCT00089661|O2|Outcome|Placebo|
566849|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566850|NCT00089661|E2|Reported Event|Denosumab 60 mg Q6M|
566799|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
566800|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
566801|NCT00089778|O2|Outcome|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
566802|NCT00089778|O1|Outcome|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other.~Because patients in Group C had no evaluable disease, response evaluation was not an appropriate endpoint. The purpose of putting such patients in the trial was they were more likely to survive long enough to complete the full sequence of intended vaccinations and permit an immunological/laboratory endpoint evaluation (not as likely for Groups A and B)."
566803|NCT00089778|E3|Reported Event|Grp C - High-risk Loco-regional Disease|"Patients whose cancer has been surgically removed but who are at risk for recurrence and local disease and who are seeking experimental adjuvant therapy.~A2 FGF-5: 117-126 peptide (adjuvant); A3 FGF-5: 172-176/217-220 peptide (adjuvant)"
566804|NCT00089778|E2|Reported Event|Grp B - Measurable Metastatic Disease That Require Aldesleukin|"Patients who require immediate treatment with IL-2. A2 FGF-5: 117-126 peptide + HD (high dose) IL-2 (prior cycle 1) Two 1 ml injection in the anterior thigh deep subcutaneous tissue within 2c of each other.~720,000 IU/kg as an intravenous bolus over a 15 minute period every 8 hours beginning on the day after immunization and continuing for up to 4 days (a maximum of 12 doses)."
566805|NCT00089778|E1|Reported Event|Grp A-measurable Metastatic Disease (no Immediate Aldesleukin)|"Patients who do not need or are ineligible for treatment with interleukin-2 (IL-2) and patients who have previously had IL-2 therapy.~A3 FGF-5 (Fibroblast growth factor 5): 172-176/217-220 peptide - two 1 ml injections in the anterior thigh deep subcutaneous tissue within 2c of each other."
566806|NCT00089674|B3|Baseline|Total|Total of all reporting groups
566807|NCT00089674|B2|Baseline|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566808|NCT00089674|B1|Baseline|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566809|NCT00089674|P2|Participant Flow|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566810|NCT00089674|P1|Participant Flow|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566811|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566812|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566813|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566814|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566815|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566816|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566817|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566818|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566819|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566820|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566821|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566822|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566823|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566824|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566825|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566826|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566827|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566828|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566829|NCT00089674|O2|Outcome|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566830|NCT00089674|O1|Outcome|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566831|NCT00089674|E2|Reported Event|Denosumab 60 mg Q6M|Denosumab 60 mg administered subcutaneous (SC) every 6 months for 3 years
566832|NCT00089674|E1|Reported Event|Placebo|Placebo administered subcutaneous every 6 months for 3 years
566833|NCT00089661|B3|Baseline|Total|Total of all reporting groups
566834|NCT00089661|B2|Baseline|Placebo|
566835|NCT00089661|B1|Baseline|Denosumab 60 mg Q6M|
566836|NCT00089661|P2|Participant Flow|Placebo|
566837|NCT00089661|P1|Participant Flow|Denosumab 60 mg Q6M|
566838|NCT00089661|O2|Outcome|Placebo|
566839|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566840|NCT00089661|O2|Outcome|Placebo|
566841|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566842|NCT00089661|O2|Outcome|Placebo|
566843|NCT00089661|O1|Outcome|Denosumab 60 mg Q6M|
566852|NCT00089648|B1|Baseline|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566853|NCT00089648|P1|Participant Flow|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566854|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566855|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566856|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566857|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566858|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566859|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566860|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566861|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566862|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566863|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566864|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566865|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566866|NCT00089648|O1|Outcome|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566867|NCT00089648|E1|Reported Event|Sunitinib|50 milligram/day for 4 consecutive weeks followed by a 2-week off-treatment period (6-week treatment cycle).
566868|NCT00089635|B1|Baseline|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566869|NCT00089635|P1|Participant Flow|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566870|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566871|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566872|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566873|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566874|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566875|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566876|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566877|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566878|NCT00089635|O1|Outcome|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566879|NCT00089635|E1|Reported Event|Panitumumab|Panitumumab was administered by intravenous (IV) infusion at a dose of 6 mg/kg once every 2 weeks until participants developed progressive disease, were unable to tolerate investigational product, or discontinued for other reasons.
566880|NCT00089609|B3|Baseline|Total|Total of all reporting groups
566881|NCT00089609|B2|Baseline|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
566882|NCT00089609|B1|Baseline|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566883|NCT00089609|P2|Participant Flow|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
566884|NCT00089609|P1|Participant Flow|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566885|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566886|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566887|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566888|NCT00089609|O2|Outcome|Main Cohort - Particpants With <75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566889|NCT00089609|O1|Outcome|Main Cohort - Particpants With ≥75% PSA Decline|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566890|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566891|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566892|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566893|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566894|NCT00089609|O2|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added.
566895|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566896|NCT00089609|O1|Outcome|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
566897|NCT00089609|O1|Outcome|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566898|NCT00089609|E2|Reported Event|Expansion Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes and Bevacizumab 15 mg/kg intravenously was given for 2 cycles. After two cycles Prednisone 10 mg by mouth daily and Thalidomide 200 mg by mouth daily was added
566899|NCT00089609|E1|Reported Event|Main Cohort - Prostate Cancer|Docetaxel 75 mg/m^2 intravenously over 60 minutes on cycle 1 day 1 repeated every 21 days. Thalidomide 200 mg by mouth daily throughout the cycle. Prednisone 10 mg by mouth daily throughout the cycle. Bevacizumab 15 mg/kg intravenously on cycle 1 day 1 every 21 days.
566900|NCT00089583|B3|Baseline|Total|Total of all reporting groups
566901|NCT00089583|B2|Baseline|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566902|NCT00089583|B1|Baseline|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566903|NCT00089583|P2|Participant Flow|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
567009|NCT00089505|B4|Baseline|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
566904|NCT00089583|P1|Participant Flow|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566905|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566906|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566907|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566908|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566909|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566910|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566911|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566912|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
566913|NCT00089583|O4|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566914|NCT00089583|O3|Outcome|PI Naïve, ART-experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI- pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566915|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566916|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
566917|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566918|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566919|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566920|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
566921|NCT00089583|O4|Outcome|PI Experienced, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, PI-experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566922|NCT00089583|O3|Outcome|PI Naïve, ART Experienced, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-experienced but PI-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566923|NCT00089583|O2|Outcome|ART-Naïve, FPV/RTV Treatment Group|HIV-1-infected, antiretroviral-naïve pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID
566924|NCT00089583|O1|Outcome|ART-Naïve, FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, antiretroviral-naive pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID)
566936|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
567238|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
566925|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566926|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566927|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566928|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566929|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566930|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566931|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566932|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566933|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566934|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566935|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
567076|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
566937|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566938|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566939|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566940|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566941|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566942|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566943|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566944|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566945|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566946|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566947|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
567077|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567148|NCT00088972|B1|Baseline|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
566948|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566949|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566950|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566951|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566952|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566953|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566954|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566955|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566956|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566957|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566958|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566970|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
567149|NCT00088972|P2|Participant Flow|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
566959|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566960|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566961|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566962|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566963|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566964|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566965|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566966|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566967|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566968|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566969|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
567078|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
566971|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566972|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566973|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566974|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566975|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566976|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566977|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566978|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566979|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566980|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566981|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
567079|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567150|NCT00088972|P1|Participant Flow|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
566982|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566983|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566984|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566985|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566986|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566987|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566988|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566989|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566990|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566991|NCT00089583|O2|Outcome|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-&lt;6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566992|NCT00089583|O1|Outcome|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
567007|NCT00089544|E1|Reported Event|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
566993|NCT00089583|E2|Reported Event|FPV/RTV Treatment Group|HIV-1-infected, PI-naïve and -experienced pediatric participants, 2 to 18 years old, receiving FPV boosted with ritonavir (FPV/RTV) BID. Participants who were 2-<6 years old received FPV oral suspension/ritonavir oral solution 20/4 or 23/3 mg/kg BID; participants who were 6 years old or older received FPV oral suspension/RTV oral solution 15/3 or 18/3 mg/kg BID. A 700/100 mg BID tablet regimen was administered to participants able to take tablets/capsules. PI-experienced participants are defined as those participants who received more than one week of prior PI therapy with no more than three PIs. Prior RTV-boosted therapy was considered as only one PI as long as the RTV dose was lower than that recommended for use of RTV as an antiretroviral agent.
566994|NCT00089583|E1|Reported Event|FPV Treatment Group|Human immunodeficiency virus type 1 (HIV-1)-infected, protease inhibitor (PI)-naïve pediatric participants, 2 to <6 years old, receiving fosamprenavir (FPV) oral suspension 30-40 milligrams per kilogram (mg/kg) twice a day (BID). PI-naïve participants are defined as those participants who received less than one week of any PI and any length of therapy with nucleoside reverse transcriptase inhibitors (NRTIs) and/or non-NRTIs (NNRTIs).
566995|NCT00089544|B3|Baseline|Total|Total of all reporting groups
566996|NCT00089544|B2|Baseline|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
566997|NCT00089544|B1|Baseline|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
566998|NCT00089544|P2|Participant Flow|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
566999|NCT00089544|P1|Participant Flow|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
567000|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
567001|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
567002|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
567003|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
567004|NCT00089544|O2|Outcome|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
567005|NCT00089544|O1|Outcome|Cohort A (Chemotherapy, Radiation, Thalidomide, Surgery)|Patients receive doxorubicin, ifosfamide, and dacarbazine IV continuously on days 1-3, 22-24, and 43-45. Patients receive G-CSF subcutaneously beginning on days 4, 25, and 46 and continuing until blood counts recover. Patients undergo radiotherapy once daily on days 7-11, 14-18, 21, 28-32, 35-39, and 42. Patients receive oral thalidomide once daily on days 7-21 and 28-42. Patients undergo surgical resection between days 84 and 98. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 12 months in the absence of unacceptable toxicity.
567006|NCT00089544|E2|Reported Event|Cohort B (Thalidomide, Radiation, Surgery)|Patients receive oral thalidomide once daily beginning on day 1 and continuing until 1 week before surgery. Patients undergo radiotherapy once daily, 5 days a week, on weeks 1-5. Patients undergo surgical resection between days 77 and 91. Beginning 2 weeks after surgery, patients receive oral thalidomide once daily for 6 months in the absence of unacceptable toxicity.
567008|NCT00089505|B5|Baseline|Total|Total of all reporting groups
567151|NCT00088972|O2|Outcome|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
567010|NCT00089505|B3|Baseline|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567011|NCT00089505|B2|Baseline|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567012|NCT00089505|B1|Baseline|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567013|NCT00089505|P4|Participant Flow|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567014|NCT00089505|P3|Participant Flow|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567015|NCT00089505|P2|Participant Flow|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567016|NCT00089505|P1|Participant Flow|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567017|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567018|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567019|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567020|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567021|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567022|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567023|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567080|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567024|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567025|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567026|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567027|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567028|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567029|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567030|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567031|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567032|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567033|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567034|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567035|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567036|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567037|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567239|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
567038|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567039|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567040|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567041|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567042|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567043|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567044|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567045|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567046|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567047|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567048|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567049|NCT00089505|O4|Outcome|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567050|NCT00089505|O3|Outcome|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567051|NCT00089505|O2|Outcome|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567081|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567240|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
567052|NCT00089505|O1|Outcome|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567053|NCT00089505|E4|Reported Event|NoNVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) once daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP daily 200mg (1 tablet orally) for 14 days before taking it twice daily plus 2 more NRTIs.
567054|NCT00089505|E3|Reported Event|NoNVP/NVP|For participants had NO SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally), TDF 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive LPV/RTV 400/100mg (3 capsules orally) twice daily plus two more NRTIs.
567055|NCT00089505|E2|Reported Event|NVP/LPV_r|For participants had SD NVP exposure prior to study entry, FTC 200mg (1 capsule orally) and TDF 300mg (1 tablet orally) daily and LPV/RTV 400/100mg (3 capsules orally) twice daily. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue LPV/RTV will receive NVP 200mg (1 tablet orally) daily for 14 days before taking it twice daily. plus 2 more NRTIs. Following the review on 6 October 2008, the DSMB recommended release of the results from this arm.
567056|NCT00089505|E1|Reported Event|NVP/NVP|For participants had single dose Nevirapine (SD NVP) exposure prior to study entry, Emtricitabine capsules(FTC) 200mg (1 capsule orally), Tenofovir disproxil fumerate (TDF) 300mg (1 tablet orally), and NVP 200mg (1 tablet orally) once daily in the morning for the first 14 days, then twice daily after 14 days. FTC and TDF may be replaced by the combination drug FTC/TDF. Participants who discontinue NVP will receive Lopinovir/Ritonovir (LPV/RTV)400/100mg (3 capsules orally) twice daily plus two more Nucleoside reverse transcriptase inhibitors (NRTIs). Following the review on 6 October 2008, the Data Safety Monitoring Board(DSMB) recommended release of the results from this arm.
567057|NCT00089479|B3|Baseline|Total|Total of all reporting groups
567058|NCT00089479|B2|Baseline|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567059|NCT00089479|B1|Baseline|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567060|NCT00089479|P2|Participant Flow|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567061|NCT00089479|P1|Participant Flow|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567062|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567063|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567064|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567065|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567066|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567067|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567068|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567069|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567070|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567071|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567072|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567073|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567074|NCT00089479|O2|Outcome|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567075|NCT00089479|O1|Outcome|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567082|NCT00089479|E2|Reported Event|AC Then XT|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Xeloda 825 mg/m^2 po (bid) [total daily dose is 1650 mg/m^2] Days 1-14 every 3 weeks for 4 cycles plus Taxotere 75 mg/m^2 iv every 3 weeks for 4 cycles
567083|NCT00089479|E1|Reported Event|AC Then T|Adriamycin 60 mg/m^2 iv plus Cytoxan 600 mg/m^2 iv repeat every 3 weeks for 4 cycles followed by Taxotere 100 mg/m^2; repeat every 3 weeks for 4 cycles
567084|NCT00089414|B4|Baseline|Total|Total of all reporting groups
567085|NCT00089414|B3|Baseline|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567086|NCT00089414|B2|Baseline|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
567087|NCT00089414|B1|Baseline|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567088|NCT00089414|P3|Participant Flow|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567089|NCT00089414|P2|Participant Flow|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
567090|NCT00089414|P1|Participant Flow|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567091|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567092|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
567093|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567094|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567095|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
567096|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567097|NCT00089414|O3|Outcome|Continuous Yasmin Plus Progesterone Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 is identical to treatment arm # 1 with the exception that the continuous administration of Yasmin will also include the administration of progesterone antagonist CDB-2914 during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. Women in treatment arms # 3 and # 1 will be exposed to continuous levels of Yasmin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567098|NCT00089414|O2|Outcome|Interrupted Yasmin|Treatment arm # 2 (interrupted Yasmin administration) will be identical to arm # 1 with the exception that the continuous administration of Yasmin will be interrupted by the substitution of placebo for Yasmin for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after Yasmin withdrawal (when they are on placebo).
567152|NCT00088972|O1|Outcome|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
567099|NCT00089414|O1|Outcome|Continuous Yasmin|Treatment arm # 1 consists of the continuous administration of Yasmin oral contraceptive (a combination of 30 µg of ethinyl estradiol and 3 mg of drospirenone) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567100|NCT00089414|E3|Reported Event|Continuous OC Plus PR Antagonist|Yasmin oral contraceptive; CDB 2914 progesterone antagonist. Treatment arm # 3 (extended EE/P with menses) is identical to treatment arm # 1 except the progesterone antagonist CDB-2914 will be administered during weeks 3, 8, and 14. Menses is anticipated to occur within 2-3 days of CDB-2914 administration. As such, menses will occur in these women at approximately the same interval as experienced by those women in treatment arm # 2 due to the local effects of the progesterone receptor antagonist on the endometrium (lining of the uterus). Thus, women in treatment arms # 3 and # 1 will be exposed to continuous levels of ethinyl estradiol and progestin, but due to the local effects of the progesterone antagonist on the endometrium, women in arm # 3 will experience menses.
567101|NCT00089414|E2|Reported Event|Interrupted OC|Treatment arm # 2 (interrupted EE/P administration) will be identical to arm # 1 with the exception that the continuous administration of EE/P will be interrupted by the substitution of placebo for EE/P for one week during weeks 3, 8, and 14 of the study. The women participating in this treatment arm will experience episodes of menstruation after EE/P withdrawal (placebo).
567102|NCT00089414|E1|Reported Event|Continuous OCP Plus Placebo|Treatment arm # 1 (extended ethinyl estradiol and progestin [EE/P]) consists of the continuous administration of 30 µg of ethinyl estradiol and 3 mg of drospirenone (Yasmin) for 15 weeks starting on day 2 to 5 of the first menstrual cycle.
567103|NCT00089297|B1|Baseline|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567104|NCT00089297|P1|Participant Flow|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567105|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567106|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567107|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567144|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567145|NCT00089076|E1|Reported Event|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567146|NCT00088972|B3|Baseline|Total|Total of all reporting groups
567147|NCT00088972|B2|Baseline|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
567108|NCT00089297|O1|Outcome|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567109|NCT00089297|E1|Reported Event|Cetuximab/Paclitaxel/Carboplatin|"Induction: Cetuximab (C225) 400 mg/m2 at wk 1 then 250 mg/m2 for 5 weeks. Paclitaxel (P) 90 mg/m2 IV and carboplatin (C) AUC = 2 IV were given weekly.~Restaging biopsy of primary site scheduled at wk 7. Concurrent chemoradiation: Radiation at 200cGy/d/5 wks for a total of 50Gy and C225 at 250 mg/m2/wk. P following C225 at 30 mg/m2/wk and C following P at AUC = 1/week. Patients with a negative biopsy continued concurrent therapy to complete radiation (68-72Gy).~Restaging biopsy of primary site: Patients with positive biopsy at wk 7 or patients without a clinical complete response at the primary site after induction therapy had re-biopsy at wk 14. If the biopsy was negative, the patients continued concurrent therapy to complete radiation (68-72 Gy). If positive, resection of the primary site was done.~Additional concurrent chemoradiation: C225 at 250mg/m2/wk IV followed by P 30mg/m2/wk IV followed by C AUC = 1/wk and RT for 3 wks."
567110|NCT00089141|B3|Baseline|Total|Total of all reporting groups
567111|NCT00089141|B2|Baseline|Placebo|Patients receive oral placebo twice daily
567112|NCT00089141|B1|Baseline|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567113|NCT00089141|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily
567114|NCT00089141|P1|Participant Flow|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567115|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567116|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567117|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567118|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567119|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567120|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567121|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567122|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567123|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567124|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567125|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567126|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567127|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567128|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567129|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567130|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567131|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567132|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567133|NCT00089141|O2|Outcome|Placebo|Patients receive oral placebo twice daily
567134|NCT00089141|O1|Outcome|Mycophenolate Mofetil|Patients receive oral mycophenolate mofetil 1000 mg twice daily.
567135|NCT00089076|B1|Baseline|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567136|NCT00089076|P1|Participant Flow|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567137|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567138|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567139|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567140|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567141|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567142|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567143|NCT00089076|O1|Outcome|MDX-010|Patients receive anti-cytotoxic T-lymphocyte-associated antigen-4 monoclonal antibody (MDX-010) IV over 90 minutes on day 1. Treatment repeats every 28 days for a total of 4 courses in the absence of disease progression or unacceptable toxicity.
567153|NCT00088972|E2|Reported Event|Arm II|Patients receive oral placebo twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
567154|NCT00088972|E1|Reported Event|Arm I|Patients receive oral celecoxib twice daily for 12 months in the absence of unacceptable toxicity or diagnosis of cancer.
567155|NCT00088907|B3|Baseline|Total|Total of all reporting groups
567156|NCT00088907|B2|Baseline|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
567157|NCT00088907|B1|Baseline|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
567158|NCT00088907|P2|Participant Flow|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
567159|NCT00088907|P1|Participant Flow|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
567160|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
567161|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
567162|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
567163|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
567164|NCT00088907|O2|Outcome|Arm II (Docetaxel and Gefitinib)|"Patients receive docetaxel as in arm I and oral gefitinib once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~gefitinib: Given at a dose of 250 mg (one tablet) orally each day starting on day 1 and continuing for days 1 to 28 of each cycle until progression."
567165|NCT00088907|O1|Outcome|Arm I (Docetaxel and Placebo)|"Patients receive docetaxel intravenously (IV) over 30-60 minutes on days 1, 8, and 15 and oral placebo once daily on days 1-28.~In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm I who have disease progression may receive single-agent oral gefitinib once daily until further disease progression.~docetaxel: Given IV~placebo: Given orally"
567166|NCT00088907|E3|Reported Event|Step 2: ZD1839|ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle.
567167|NCT00088907|E2|Reported Event|Step 1: Docetaxel+ZD1839|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8, and 15 of a 28-day schedule.~ZD1839 (Iressa, gefitinib) 250 mg/daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
567168|NCT00088907|E1|Reported Event|Step 1: Docetaxel+Placebo|"Premedication: Dexamethasone~Docetaxel as a 60 m inute infusion 35mg/m2 to be given on days 1,8,and 15 of a 28-day schedule~Placebo one tablet daily orally starting on day 1. Treatment to continue from days 1-28 of each cycle."
567169|NCT00088881|B1|Baseline|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567237|NCT00088374|P1|Participant Flow|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
567170|NCT00088881|P1|Participant Flow|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567171|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567172|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567173|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567174|NCT00088881|O1|Outcome|Treatment|"R-CHOP: Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.~Zevalin™Radioimmunotherapy: Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.~Radiotherapy: Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy."
567175|NCT00088881|E3|Reported Event|Step 3 - Radiation Therapy|Patients with residual disease by CT scan or positron emission tomography (PET) scan after 12 weeks after radioimmunotherapy undergo conventional involved-field radiotherapy.
567176|NCT00088881|E2|Reported Event|Step 2 - Zevalin™ Radioimmunotherapy|Beginning no more than 9 weeks after the last course of R-CHOP, patients receive rituximab IV on day 1 followed by indium In 111 ibritumomab tiuxetan IV over 10 minutes for imaging studies. Patients then receive rituximab IV followed by yttrium Y 90 ibritumomab tiuxetan IV over 10 minutes on day 8.
567177|NCT00088881|E1|Reported Event|Step 1 - R-CHOP|Patients receive R-CHOP every 21 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) after 2 courses receive 2 additional courses. Patients achieving a partial response, uncertain CR, or stable disease receive 4 additional courses. Patients are evaluated 3 weeks after the last course of therapy. Patients with progressive disease go off study.
567178|NCT00088634|B3|Baseline|Total|Total of all reporting groups
567179|NCT00088634|B2|Baseline|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567180|NCT00088634|B1|Baseline|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567181|NCT00088634|P2|Participant Flow|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567182|NCT00088634|P1|Participant Flow|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567183|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567184|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567185|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567186|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567187|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567188|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567189|NCT00088634|O2|Outcome|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567190|NCT00088634|O1|Outcome|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567191|NCT00088634|E2|Reported Event|Placebo|Matching placebo to lurasidone 40 mg tablets taken once/day
567192|NCT00088634|E1|Reported Event|Lurasidone 80 mg|2 40 mg lurasidone tablets taken once/day
567193|NCT00088621|B1|Baseline|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
567194|NCT00088621|P1|Participant Flow|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the participant flow is based on the number of subjects that entered the extension study which is 61 subjects.
567195|NCT00088621|O1|Outcome|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
567196|NCT00088621|E1|Reported Event|Lurasidone 80 mg|Lurasidone 80mg oral tablet. The number of subjects that represent the baseline must have taken 1 dose of study medication and had post-baseline assessment. 2 subjects were randomized and did not take study medication and thus 59 subjects is listed in the baseline group.
567197|NCT00088595|B1|Baseline|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567198|NCT00088595|P1|Participant Flow|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567199|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567200|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567201|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567202|NCT00088595|O3|Outcome|Pasireotide >1500-≤2400 μg|SOM230 (Pasireotide), more than 750µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567203|NCT00088595|O2|Outcome|Pasireotide >900-≤1500 μg|SOM230 (Pasireotide), more than 450µg twice daily dose titration up to 750µg twice daily, subcutaneous injection.
567204|NCT00088595|O1|Outcome|Pasireotide 300-≤900 μg|SOM230 (Pasireotide), 150µg twice daily dose titration up to 450µg twice daily, subcutaneous injection.
567205|NCT00088595|O4|Outcome|Pasireotide Any Dose|SOM230 (Pasireotide), 300 ug - 2400 ug / day
567206|NCT00088595|O3|Outcome|Pasireotide >1500 - ≤2400 μg|SOM230 (Pasireotide), >1500 - ≤2400 μg / day
567207|NCT00088595|O2|Outcome|Pasireotide >900 - ≤1500 μg|SOM230 (Pasireotide), >900 - ≤1500 μg / day
567208|NCT00088595|O1|Outcome|Pasireotide 300 - ≤900 μg|SOM230 (Pasireotide), 300 - ≤900 μg / day
567209|NCT00088595|O1|Outcome|Pasireotide (Any Dose)|SOM230 (Pasireotide), 150µg twice daily dose titration up to 1200µg twice daily, subcutaneous injection.
567210|NCT00088595|E3|Reported Event|Pasireotide > 1500 ≤ 2400 μg|Pasireotide > 1500 ≤ 2400 μg / day
567211|NCT00088595|E2|Reported Event|Pasireotide > 900 ≤ 1500 μg|Pasireotide > 900 ≤ 1500 μg / day
567212|NCT00088595|E1|Reported Event|Pasireotide 300 ≤ 900 μg|Pasireotide 300 ≤ 900 μg / day
567213|NCT00088465|B1|Baseline|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567214|NCT00088465|P1|Participant Flow|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567215|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567216|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567217|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567218|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567219|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567220|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567221|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567222|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567223|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567224|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567225|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567226|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567227|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567228|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567229|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567230|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567231|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567232|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567233|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567234|NCT00088465|O1|Outcome|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567235|NCT00088465|E1|Reported Event|Intramuscular Olanzapine Depot|Intramuscular (IM) olanzapine depot flexible dosing and flexible interval
567236|NCT00088374|B1|Baseline|VHL Associated Renal Tumors|17-AAG intravenous infusions at a dose of 300 mg/m2 into a vein once a week for 3 weeks out of every 4, for 3 months; on days 1, 8, and 15 of 28 cycles. The infusions last up to 1 to 2 hours.
567241|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
567242|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
567243|NCT00088374|O1|Outcome|Participants With VHL Associated Renal Tumors|
567244|NCT00088374|E1|Reported Event|Participants With VHL Associated Renal Tumors|
567245|NCT00088218|B3|Baseline|Total|Total of all reporting groups
567246|NCT00088218|B2|Baseline|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
567247|NCT00088218|B1|Baseline|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
567248|NCT00088218|P2|Participant Flow|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
567249|NCT00088218|P1|Participant Flow|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
567250|NCT00088218|O2|Outcome|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
567251|NCT00088218|O1|Outcome|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
567252|NCT00088218|E2|Reported Event|Clofarabine Plus Ara-C|Clofarabine IV 30 mg/m^2 daily times 5 days + Ara-C 20 mg/m^2 subcutaneously daily times 14 days.
567253|NCT00088218|E1|Reported Event|Clofarabine|Clofarabine intravenous (IV) 30 mg/m^2 daily times 5 days
567254|NCT00088166|B3|Baseline|Total|Total of all reporting groups
567255|NCT00088166|B2|Baseline|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567256|NCT00088166|B1|Baseline|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567257|NCT00088166|P2|Participant Flow|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567258|NCT00088166|P1|Participant Flow|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567259|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567260|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567261|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567262|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567263|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567264|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567265|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567266|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567267|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567268|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567269|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567270|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567271|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567272|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567273|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567274|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567275|NCT00088166|O2|Outcome|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567276|NCT00088166|O1|Outcome|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567277|NCT00088166|E2|Reported Event|Placebo|Patient will receive placebo hCRF and any open-label dexamethasone that they are currently taking
567278|NCT00088166|E1|Reported Event|hCRF|Patients will take hCRF (XERECEPT) 2mg/day and open label-dexamethasone they are currently taking.
567279|NCT00088153|B3|Baseline|Total|Total of all reporting groups
567280|NCT00088153|B2|Baseline|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
567281|NCT00088153|B1|Baseline|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
567282|NCT00088153|P2|Participant Flow|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
567283|NCT00088153|P1|Participant Flow|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
567284|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
567316|NCT00087646|P3|Participant Flow|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
567562|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567285|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
567286|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
567287|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
567288|NCT00088153|O2|Outcome|Placebo|"Mature girls with anorexia nervosa (AN) randomized to this arm received placebo patches and cyclic placebo pills.~Immature girls with AN randomized to this arm received placebo pills. All subjects received supplemental calcium (1200 mg) and vitamin D (400 IU) daily"
567289|NCT00088153|O1|Outcome|Physiologic Estrogen Replacement|Mature girls with anorexia nervosa (AN) (bone age ≥15 years) randomized this arm received transdermal 17-β estradiol (100 mcg patch applied twice weekly) continuously over the study duration. Girls randomized to the active estradiol patch also received medroxyprogesterone 2.5 mg daily for 10 days each month. Immature girls with AN (bone age<15 years, N=14) randomized to this arm received escalating doses of oral ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the second 6 months, and 11.25 mcg daily for the last 6 months). All subjects were given 1200 mg calcium carbonate and 400 IU vitamin D daily.
567290|NCT00088153|E2|Reported Event|Placebo|Mature girls with anorexia nervosa with a bone age of 15 years of greater: Placebo patches; Immature girls with anorexia nervosa with a bone age of less than 15 years: Placebo pills
567291|NCT00088153|E1|Reported Event|Physiologic Estrogen Replacement|"Mature girls with anorexia nervosa (bone age 15 or greater): Transdermal estradiol (100 mcg) with cyclic progesterone (days 1-10 of each month).~Immature girls with anorexia nervosa (bone age less than 15 years): Ethinyl estradiol (3.75 mcg daily for the first 6 months, 7.5 mcg daily for the next 6 months, and 11.25 mcg daily for the final 6 months of the study"
567292|NCT00087698|B1|Baseline|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567293|NCT00087698|P1|Participant Flow|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567294|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567295|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567296|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567297|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567298|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567299|NCT00087698|O1|Outcome|Pemetrexed|pemetrexed: 500 mg/m2, intravenous, every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous, every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 gray (Gy)
567300|NCT00087698|E1|Reported Event|Pemetrexed|pemetrexed: 500 mg/m2, intravenous (IV), every 21 days x 4 cycles cisplatin: 75 mg/m2, intravenous (IV), every 21 days x 4 cycles chemotherapy, surgery then chest radiation x 54 Gy
567301|NCT00087685|B1|Baseline|RAD001|10 mg orally daily/28-day cycles
567302|NCT00087685|P1|Participant Flow|RAD001|10 mg orally daily/28-day cycles
567303|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
567304|NCT00087685|O1|Outcome|RAD001|10 mg orally daily/28-day cycles
567305|NCT00087685|E1|Reported Event|RAD001|10 mg orally daily/28-day cycles
567306|NCT00087672|B1|Baseline|CC-5013|10 mg orally daily
567307|NCT00087672|P1|Participant Flow|CC-5013|10 mg orally daily
567308|NCT00087672|O1|Outcome|CC-5013|10 mg orally daily
567309|NCT00087672|E1|Reported Event|CC-5013|10 mg orally daily
567310|NCT00087646|B5|Baseline|Total|Total of all reporting groups
567311|NCT00087646|B4|Baseline|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567312|NCT00087646|B3|Baseline|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
567313|NCT00087646|B2|Baseline|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
567314|NCT00087646|B1|Baseline|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567315|NCT00087646|P4|Participant Flow|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567810|NCT00086190|P3|Participant Flow|Placebo|Placebo was made to match treatment options.
567317|NCT00087646|P2|Participant Flow|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
567318|NCT00087646|P1|Participant Flow|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567319|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567320|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
567321|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
567322|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567323|NCT00087646|O4|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567324|NCT00087646|O3|Outcome|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
567325|NCT00087646|O2|Outcome|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
567326|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567327|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
567328|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
567329|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567330|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567331|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567332|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567333|NCT00087646|O2|Outcome|Group B + Group D|"Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
567334|NCT00087646|O1|Outcome|Group A + Group C|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks."
567335|NCT00087646|O2|Outcome|Group C + Group D|"Group C - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.~Group D - Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks."
567336|NCT00087646|O1|Outcome|Group A + Group B|"Group A - Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.~Group B - Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks."
567337|NCT00087646|O2|Outcome|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567338|NCT00087646|O1|Outcome|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567339|NCT00087646|E4|Reported Event|Group D|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 48 weeks.
567340|NCT00087646|E3|Reported Event|Group C|Participants received 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 72 weeks.
567341|NCT00087646|E2|Reported Event|Group B|Participants received 360 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 36 weeks.
567342|NCT00087646|E1|Reported Event|Group A|Participants received 360 microgram (mcg) of peginterferon alfa-2a (PEG-IFN alfa-2a) once weekly plus 1000/1200 mg of ribavirin daily for 12 weeks, and thereafter 180 mcg of PEG-IFN alfa-2a once weekly plus 1000/1200 mg of ribavirin daily for 60 weeks.
567343|NCT00087633|B3|Baseline|Total|Total of all reporting groups
567432|NCT00087568|B1|Baseline|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567344|NCT00087633|B2|Baseline|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
567345|NCT00087633|B1|Baseline|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
567346|NCT00087633|P2|Participant Flow|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
567347|NCT00087633|P1|Participant Flow|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
567348|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
567349|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
567350|NCT00087633|O2|Outcome|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
567351|NCT00087633|O1|Outcome|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
567352|NCT00087633|E2|Reported Event|Observation Arm|No antiviral therapy for HCV unless recurrence of HCV was histologically demonstrated. Once histological recurrence was demonstrated, patients received the same antiviral regimen as patients in the prophylaxis arm (ie, 48 weeks of combined PEG-IFN alfa-2a and ribavirin)
567353|NCT00087633|E1|Reported Event|Prophylaxis Arm|Pegylated interferon alfa-2a subcutaneously (SC) 135 μg/week for 4 weeks, then increased to 180 μg/week for the next 44 weeks, plus Ribavirin orally 400 mg/day (initial) to 1000 mg/day for patients <75 kg or 1200 mg/day for patients ≥75 kg PO (escalated) (maximum) administered orally
567354|NCT00087607|B3|Baseline|Total|Total of all reporting groups
567355|NCT00087607|B2|Baseline|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567356|NCT00087607|B1|Baseline|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567357|NCT00087607|P2|Participant Flow|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b (12 kD) [PEG-Intron] at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin [Rebetol] 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567358|NCT00087607|P1|Participant Flow|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a (40 kD) [Pegasys] at a dosage of 180 microgram (μg), subcutaneously (SC), once a week plus Ribavirin [Copegus] 1000 or 1200 milligram (mg)/day), orally, [according to body weight, lesser than or greater than/equal to (< or >/=) 75 kilogram (kg), respectively] twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567359|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567411|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567866|NCT00086190|E1|Reported Event|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567360|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567361|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567362|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567363|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567364|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567365|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567366|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567367|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567368|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567369|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567370|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567371|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567372|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567373|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567374|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567375|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567376|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567377|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567378|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567379|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567380|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567381|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567382|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567383|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567384|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567385|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567386|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567387|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567388|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a180 μg SC once weekly plus Ribavirin1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567389|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567390|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567391|NCT00087607|O2|Outcome|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567392|NCT00087607|O1|Outcome|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567393|NCT00087607|E2|Reported Event|Peginterferon Alfa-2b + Ribavirin|Participants received Peginterferon alfa-2b at a dosage of 1.5 μg/kg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567394|NCT00087607|E1|Reported Event|Peginterferon Alfa-2a + Ribavirin|Participants received Peginterferon alfa-2a at a dosage of 180 μg SC once a week plus Ribavirin 1000 or 1200 mg/day, orally (< or >/= 75 kg body weight, respectively) twice daily during the randomized treatment period for 12 weeks. Participants who completed the randomized treatment period of 12 weeks and wished to continue therapy were given Peginterferon alfa-2a 180 μg SC once weekly plus Ribavirin 1000 or 1200 mg/day orally (< or >/=75 kg body weight, respectively) twice daily for an additional 36 weeks to complete a full 48-week treatment course. After treatment completion, participants were followed-up for safety for 24 weeks.
567395|NCT00087594|B3|Baseline|Total|Total of all reporting groups
567396|NCT00087594|B2|Baseline|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567397|NCT00087594|B1|Baseline|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567398|NCT00087594|P2|Participant Flow|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567399|NCT00087594|P1|Participant Flow|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 microgram (mcg) (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 milligram (mg)/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567400|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567401|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567402|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567403|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567404|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567405|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567406|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567407|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567408|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567409|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567410|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567563|NCT00087152|O1|Outcome|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567412|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567413|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567414|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567415|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567416|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567417|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567418|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567419|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567420|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567421|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567422|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567423|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567424|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567425|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567426|NCT00087594|O2|Outcome|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567427|NCT00087594|O1|Outcome|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567428|NCT00087594|E2|Reported Event|Self-Administration Therapy|Participants received the peginterferon alfa-2a plus ribavirin at home as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for G2/3, and for 48 weeks for G1; oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567429|NCT00087594|E1|Reported Event|Direct Observed Therapy|Participants received the peginterferon alfa-2a plus ribavirin at the clinic as: subcutaneous peginterferon alfa-2a 180 mcg (once in a week) for 24 weeks for Genotype 2 or 3 (G2/3), and for 48 weeks for Genotype 1 (G1); oral ribavirin 800 mg/day (twice in a day) for 24 weeks for G2/3, and 1000 or 1200 mg/day (twice in a day) for 48 weeks for G1.
567430|NCT00087568|B3|Baseline|Total|Total of all reporting groups
567431|NCT00087568|B2|Baseline|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567588|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567433|NCT00087568|P2|Participant Flow|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567434|NCT00087568|P1|Participant Flow|Non-Responders|Participants received Pegasys 180 micrograms (µg) subcutaneously (SC) once a week and ribavirin 1000 or 1200 milligrams per day [mg/day (< or >=75 kg body weight, respectively)], orally in divided doses for 60 weeks.
567435|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567436|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567437|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567438|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567439|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567440|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567441|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567442|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567443|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567444|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567445|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567446|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567447|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567448|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567449|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567450|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567451|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567452|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567453|NCT00087568|O2|Outcome|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567454|NCT00087568|O1|Outcome|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567455|NCT00087568|E2|Reported Event|Non-Tolerators|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively) orally in divided doses for 36 weeks.
567456|NCT00087568|E1|Reported Event|Non-Responders|Participants received Pegasys 180 µg subcutaneously (SC) once a week and ribavirin 1000 or 1200 mg/day (< or >=75 kg body weight, respectively), orally in divided doses for 60 weeks.
567457|NCT00087555|B4|Baseline|Total|Total of all reporting groups
567458|NCT00087555|B3|Baseline|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
567459|NCT00087555|B2|Baseline|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
567460|NCT00087555|B1|Baseline|Placebo|Placebo taken as two equally divided nightly doses
567461|NCT00087555|P3|Participant Flow|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
567462|NCT00087555|P2|Participant Flow|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
567463|NCT00087555|P1|Participant Flow|Placebo|Placebo taken as two equally divided nightly doses
567464|NCT00087555|O3|Outcome|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
567465|NCT00087555|O2|Outcome|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
567466|NCT00087555|O1|Outcome|Placebo|Placebo taken as two equally divided nightly doses
567467|NCT00087555|E3|Reported Event|Xyrem (Sodium Oxybate) 6.0g|Xyrem 6.0g taken as two equally divided nightly doses
567468|NCT00087555|E2|Reported Event|Xyrem (Sodium Oxybate) 4.5g|Xyrem 4.5g taken as two equally divided nightly doses
567469|NCT00087555|E1|Reported Event|Placebo|Placebo taken as two equally divided nightly doses
567470|NCT00087529|B3|Baseline|Total|Total of all reporting groups
567471|NCT00087529|B2|Baseline|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567472|NCT00087529|B1|Baseline|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567473|NCT00087529|P2|Participant Flow|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567474|NCT00087529|P1|Participant Flow|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567475|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567476|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567477|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567478|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567479|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567480|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567481|NCT00087529|O2|Outcome|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567482|NCT00087529|O1|Outcome|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567483|NCT00087529|E2|Reported Event|Rituximab|Participants received rituximab 1 gram via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of rituximab separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567484|NCT00087529|E1|Reported Event|Placebo|Participants received the placebo equivalent to rituximab via IV infusion, for a treatment period of 96 weeks. Each treatment course involved 2 separate infusions of placebo separated by 14 days without study drug. The first course was administered on Days 1 and 15, and subsequent courses were initiated every 24 weeks.
567485|NCT00087516|B4|Baseline|Total|Total of all reporting groups
567486|NCT00087516|B3|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
567487|NCT00087516|B2|Baseline|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567488|NCT00087516|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567489|NCT00087516|P4|Participant Flow|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
567490|NCT00087516|P3|Participant Flow|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
567491|NCT00087516|P2|Participant Flow|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567492|NCT00087516|P1|Participant Flow|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567720|NCT00086411|E2|Reported Event|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
567493|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
567494|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
567495|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567496|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567497|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
567498|NCT00087516|O3|Outcome|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
567499|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567500|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567501|NCT00087516|O4|Outcome|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
567502|NCT00087516|O3|Outcome|Placebo/ Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
567503|NCT00087516|O2|Outcome|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567504|NCT00087516|O1|Outcome|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567505|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
567506|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567507|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567508|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
567509|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567510|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567511|NCT00087516|O3|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 or 200 mg q.d. during the 80-week Phase B study period.
567512|NCT00087516|O2|Outcome|Sitagliptin 200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567513|NCT00087516|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567514|NCT00087516|E4|Reported Event|Placebo/Sitagliptin 200 mg|The Placebo/Sitagliptin 200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 200 mg q.d. during the 80-week Phase B study period.
567537|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567515|NCT00087516|E3|Reported Event|Placebo/Sitagliptin 100 mg|The Placebo/Sitagliptin 100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo tablets once daily during the 24-week Phase A study period followed by oral tablets of sitagliptin 100 mg q.d. during the 80-week Phase B study period.
567516|NCT00087516|E2|Reported Event|Sitagliptin 200 mg/200 mg|The Sitagliptin 200 mg/200 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 200 mg q.d. for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567517|NCT00087516|E1|Reported Event|Sitagliptin 100 mg/100 mg|The Sitagliptin 100 mg/100 mg group includes data from patients randomized to receive treatment with oral tablets of sitagliptin 100 mg q.d. (once daily) for up to 104 weeks (including the 24-week Phase A study period and 80-week Phase B study period).
567518|NCT00087490|B3|Baseline|Total|Total of all reporting groups
567519|NCT00087490|B2|Baseline|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567520|NCT00087490|B1|Baseline|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567521|NCT00087490|P2|Participant Flow|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg per kilogram per dose (15 mg/kg/dose) over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567522|NCT00087490|P1|Participant Flow|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 milligram (mg). Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented methicillin-resistant Staphylococcus aureus (MRSA) bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567523|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567524|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567525|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567526|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567527|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567528|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567529|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567530|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567531|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567532|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567533|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567534|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567535|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567536|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567867|NCT00086047|B3|Baseline|Total|Total of all reporting groups
567538|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567539|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567540|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567541|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567542|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567543|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567544|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567545|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567546|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567547|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567548|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567549|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567550|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567551|NCT00087490|O2|Outcome|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567552|NCT00087490|O1|Outcome|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567553|NCT00087490|E2|Reported Event|Vancomycin|Vancomycin intravenous infusion every 12 hours (twice daily) at a dose of 15 mg/kg/dose over a period of at minimum 60 minutes for 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567554|NCT00087490|E1|Reported Event|Linezolid|Linezolid intravenous infusion or oral tablets every 12 hours (twice daily) at a dose of 600 mg. Intravenous infusion was administered over a period of 60-90 minutes. Duration of study treatment was 7 to 14 days except in cases of documented MRSA bacteremia where it could be extended to 21 days based upon investigator’s discretion.
567555|NCT00087438|B1|Baseline|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
567556|NCT00087438|P1|Participant Flow|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
567557|NCT00087438|O1|Outcome|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
567558|NCT00087438|E1|Reported Event|Stereotactic Body Radiation Therapy (SBRT)|"20 Gy per fraction for 3 fractions over 1.5-2 weeks, for a total of 60 Gy~stereotactic body radiation therapy"
567559|NCT00087152|B1|Baseline|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567560|NCT00087152|P1|Participant Flow|Imatinib Mesylate & Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567561|NCT00087152|O1|Outcome|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567721|NCT00086411|E1|Reported Event|1: Bup+MM|bupropion and MM with placebo patch
567564|NCT00087152|E1|Reported Event|Imatinib Mesylate and Capecitabine|Imatinib Mesylate 400 mg by mouth daily for 21 day cycle. Capecitabine 1,000 mg/m^2 by mouth twice daily Days 1-14 of each 21 day cycle.
567565|NCT00087139|B4|Baseline|Total|Total of all reporting groups
567566|NCT00087139|B3|Baseline|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567567|NCT00087139|B2|Baseline|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567568|NCT00087139|B1|Baseline|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567569|NCT00087139|P3|Participant Flow|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567570|NCT00087139|P2|Participant Flow|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567571|NCT00087139|P1|Participant Flow|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567572|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567573|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567574|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567575|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567576|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567577|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567578|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567579|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567580|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567581|NCT00087139|O3|Outcome|Ixabepilone - Two Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567582|NCT00087139|O2|Outcome|Ixabepilone - Prior Taxane|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567583|NCT00087139|O1|Outcome|Ixabepilone - no Prior Chemo|All patients on this study received the same treatment but were categorized into 3 strata, including the no prior chemo stratum, the prior taxane stratum, and two prior chemo stratum. Only eligible and treated patients are included in the analysis.
567584|NCT00087139|E1|Reported Event|Ixabepilone|All patients who received protocol therapy, regardless of eligibility, were evaluated for toxicities.
567585|NCT00086996|B1|Baseline|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567586|NCT00086996|P1|Participant Flow|Chemo Plus RT, Surgery, Chemo|"Neoadjuvant chemoradiotherapy: Patients receive oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and fluorouracil (5-FU) 180 mg/m^2/day infusion continuously on days 8-43. Beginning on day 8, patients also undergo radiotherapy at 180 centigray (cGy)/day, 5 days a week, for 5 weeks to a total dose of 4,500 cGy.~Surgery: Patients with stable disease or better undergo surgical resection 4-10 weeks after completion of chemoradiotherapy. The surgical technique will depend upon the location and extent of tumor and individual surgeon preference.~Adjuvant chemotherapy: Beginning 4-10 weeks after surgery, patients receive chemotherapy comprising oxaliplatin 85 mg/m^2 by 2-hour IV infusion days 1, 15, and 29 and 5-FU 180 mg/m^2/day by 24-hour infusion continuously on days 1-36."
567587|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567722|NCT00086385|B5|Baseline|Total|Total of all reporting groups
567589|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567590|NCT00086996|O1|Outcome|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567591|NCT00086996|E1|Reported Event|Chemo Plus RT, Surgery, Chemo|Neoadjuvant fluorouracil, oxaliplatin and radiation therapy followed by conventional surgery and adjuvant fluoruracil and oxaliplatin
567592|NCT00086684|B4|Baseline|Total|Total of all reporting groups
567593|NCT00086684|B3|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
567594|NCT00086684|B2|Baseline|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
567595|NCT00086684|B1|Baseline|PLACEBO|
567596|NCT00086684|P3|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
567597|NCT00086684|P2|Participant Flow|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
567598|NCT00086684|P1|Participant Flow|PLACEBO|
567599|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
567600|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
567601|NCT00086684|O1|Outcome|PLACEBO|
567602|NCT00086684|O3|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
567603|NCT00086684|O2|Outcome|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
567604|NCT00086684|O1|Outcome|PLACEBO|
567605|NCT00086684|E3|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG TID|One 100 mg pentosan polysulfate sodium capsule TID (three times a day)
567606|NCT00086684|E2|Reported Event|Pentosan Polysulfate Sodium (ELMIRON) 100MG QD|One 100 mg pentosan polysulfate sodium capsule QD (once daily)
567607|NCT00086684|E1|Reported Event|PLACEBO|
567608|NCT00086619|B3|Baseline|Total|Total of all reporting groups
567609|NCT00086619|B2|Baseline|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
567610|NCT00086619|B1|Baseline|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
567611|NCT00086619|P2|Participant Flow|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
567612|NCT00086619|P1|Participant Flow|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
567613|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
567614|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
567615|NCT00086619|O2|Outcome|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
567616|NCT00086619|O1|Outcome|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
567617|NCT00086619|E2|Reported Event|Ascending Dose PTH|Participants received ascending dose synthetic hPTH 1-34 (20-30-40 mcg/day).
567618|NCT00086619|E1|Reported Event|Constant Dose PTH|Participants received constant dose synthetic hPTH 1-34 (30 mcg/day).
567619|NCT00086580|B3|Baseline|Total|Total of all reporting groups
567620|NCT00086580|B2|Baseline|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567621|NCT00086580|B1|Baseline|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567622|NCT00086580|P2|Participant Flow|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567623|NCT00086580|P1|Participant Flow|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567624|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567625|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567626|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567627|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567628|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567629|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567630|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567811|NCT00086190|P2|Participant Flow|Venlafaxine Extended Release|Optimal venlafaxine extended release dosage was determined on a per patient basis. The mean dosage at week 12 was 121 +/- 75 mg/day.
567631|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567632|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567633|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567634|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567635|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567636|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567637|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567638|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567639|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567640|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567641|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567642|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567643|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567644|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567645|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567646|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567647|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567648|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567649|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567650|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567651|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567652|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567653|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567654|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567655|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567656|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567723|NCT00086385|B4|Baseline|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567657|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567658|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567659|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567660|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567661|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567662|NCT00086580|O2|Outcome|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567663|NCT00086580|O1|Outcome|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567664|NCT00086580|E2|Reported Event|Fludarabine Alone|Participants received fludarabine monotherapy 25 mg/m^2 IV daily for the first 5 days of each 28 day cycle for up to 6 cycles.
567665|NCT00086580|E1|Reported Event|Combination Arm (FluCAM)|Participants received both fludarabine (Fludara) and alemtuzumab (Campath) intravenously. Initial escalation of alemtuzumab from 3 to 30 mg (escalation can take up to 14 days). Up to six cycles of fludarabine 30 mg/m^2 intravenous (IV) followed by alemtuzumab 30 mg IV on the first 3 days of each 28 day cycle.
567666|NCT00086515|B3|Baseline|Total|Total of all reporting groups
567667|NCT00086515|B2|Baseline|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567668|NCT00086515|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567669|NCT00086515|P2|Participant Flow|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567670|NCT00086515|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567671|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567672|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567673|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567674|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567675|NCT00086515|O2|Outcome|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567676|NCT00086515|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567868|NCT00086047|B2|Baseline|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
567677|NCT00086515|E2|Reported Event|Placebo / Glipizide 5 mg|"The Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral~tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase~B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with~oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated,~in a blinded fashion, to a maximum dose of 15 mg/day."
567678|NCT00086515|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
567679|NCT00086502|B3|Baseline|Total|Total of all reporting groups
567680|NCT00086502|B2|Baseline|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567681|NCT00086502|B1|Baseline|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567682|NCT00086502|P2|Participant Flow|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567683|NCT00086502|P1|Participant Flow|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567684|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567685|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567686|NCT00086502|O2|Outcome|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567687|NCT00086502|O1|Outcome|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567688|NCT00086502|E2|Reported Event|Placebo|The Placebo group includes data from patients randomized to receive treatment with placebo matching sitagliptin 100 mg tablet once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567689|NCT00086502|E1|Reported Event|Sitagliptin 100 mg|The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label pioglitazone 15 mg oral tablets (total daily dose 30 to 45 mg/day).
567690|NCT00086450|B3|Baseline|Total|Total of all reporting groups
567691|NCT00086450|B2|Baseline|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567692|NCT00086450|B1|Baseline|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567693|NCT00086450|P2|Participant Flow|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567694|NCT00086450|P1|Participant Flow|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567695|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567696|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567697|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567698|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567699|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567700|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567701|NCT00086450|O2|Outcome|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567702|NCT00086450|O1|Outcome|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567703|NCT00086450|E2|Reported Event|Coronary Artery Bypass Graft|Coronary Artery Bypass Graft
567704|NCT00086450|E1|Reported Event|Percutaneous Coronary Intervention|Percutaneous Coronary Intervention
567705|NCT00086411|B5|Baseline|Total|Total of all reporting groups
567706|NCT00086411|B4|Baseline|4 Patch+Mayo|patch and Mayo counseling with placebo patch
567707|NCT00086411|B3|Baseline|3 Patch+MM|patch and MM with placebo pills
567708|NCT00086411|B2|Baseline|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
567709|NCT00086411|B1|Baseline|1: Bup+MM|bupropion and MM with placebo patch
567710|NCT00086411|P4|Participant Flow|4 Patch+Mayo|patch and Mayo counseling with placebo patch
567711|NCT00086411|P3|Participant Flow|3 Patch+MM|patch and MM with placebo pills
567712|NCT00086411|P2|Participant Flow|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
567713|NCT00086411|P1|Participant Flow|1 Bup+MM|bupropion and MM with placebo patch
567714|NCT00086411|O4|Outcome|4 Patch+Mayo|patch and Mayo counseling with placebo patch
567715|NCT00086411|O3|Outcome|3 Patch+mm|patch and MM with placebo pills
567716|NCT00086411|O2|Outcome|2 Bup+Mayo|bupropion and Mayo counseling with placebo patch.
567717|NCT00086411|O1|Outcome|1: Bup+MM|bupropion and MM with placebo patch
567718|NCT00086411|E4|Reported Event|4 Patch+Mayo|patch and Mayo counseling with placebo patch
567719|NCT00086411|E3|Reported Event|3 Patch+mm|patch and MM with placebo pills
567724|NCT00086385|B3|Baseline|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567725|NCT00086385|B2|Baseline|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567726|NCT00086385|B1|Baseline|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567727|NCT00086385|P4|Participant Flow|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567728|NCT00086385|P3|Participant Flow|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567729|NCT00086385|P2|Participant Flow|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567730|NCT00086385|P1|Participant Flow|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567731|NCT00086385|O4|Outcome|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567732|NCT00086385|O3|Outcome|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567733|NCT00086385|O2|Outcome|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567734|NCT00086385|O1|Outcome|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567735|NCT00086385|E4|Reported Event|Tailored/No Extended NRT|"This condition is identical to the Tailored/NRT condition except that no NRT is available after completion of the Brief Treatment.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567736|NCT00086385|E3|Reported Event|Extended Tailored Counseling + NRT|"Tailored Counseling Treatment- The primary goal of the extended treatment is to prevent relapse. Secondary goal is to encourage initiation of abstinence for those who have no attained it by Week 12, and re-initiation of abstinence after slips. Subjects will participate in the Brief Treatment followed by individual sessions. The first extended treatment counseling session will occur at Week 10. Additional sessions will be held every two weeks then every four weeks, and finally at Weeks 44 and 52. Each session will be 20-30 minutes long. Between sessions subjects will be contacted by phone for brief check-ins (5-10 minutes).~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567812|NCT00086190|P1|Participant Flow|Paroxetine|Optimal paroxetine dosage was determined on a per patient basis. The mean dosage at week 12 was 24 +/- 11 mg/day.
567813|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567737|NCT00086385|E2|Reported Event|Extended NRT|"Pharmacological Treatment - Following completion of the Brief Treatment, subjects assigned to this condition will continue receiving NRT for up to 52 weeks. Subjects in this condition will be encouraged to continue NRT through Week 24. If a subject who terminates NRT and resumes smoking, before Week 50, will be instructed to set a quite date and resume NRT.~Counseling Treatment - This is identical to the Brief Counseling described above.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567738|NCT00086385|E1|Reported Event|Brief Treatment|"Pharmacological Treatment - Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement treatment~Brief Counseling - The counseling intervention consist of five 90-minute group meetings.~No further treatment during Weeks 12-52.~Nicotine polacrilex, Bupropion : Subjects receive 12 weeks of bupropion treatment and 10 weeks of nicotine replacement."
567739|NCT00086346|B3|Baseline|Total|Total of all reporting groups
567740|NCT00086346|B2|Baseline|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567741|NCT00086346|B1|Baseline|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567742|NCT00086346|P2|Participant Flow|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567743|NCT00086346|P1|Participant Flow|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567744|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567745|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567746|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567747|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567748|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567749|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567750|NCT00086346|O2|Outcome|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567751|NCT00086346|O1|Outcome|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567752|NCT00086346|E2|Reported Event|Calcineurin Inhibitors (CNI) Continuation|Calcineurin Inhibitors administered per local practice to attain target trough levels of 3 to 10 ng/mL (tacrolimus) or 50 to 250 ng/mL (cyclosporin A), respectively.
567781|NCT00086281|B2|Baseline|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567753|NCT00086346|E1|Reported Event|Sirolimus (SRL) Conversion|Sirolimus was administered once daily. A loading dose of sirolimus, 10 to 15 mg, was administered in divided doses on day 1: the first dose was given after collection of the sirolimus trough level and a minimum of 4 hours following the last dose of CNI, and the second dose approximately 12 hours after the first dose. On days 2 through 6, sirolimus was administered in a dose of 3 to 5 mg/day. For the remaining study period, day 7 through month 72, appropriate daily doses of sirolimus were administered to attain the recommended trough concentrations of 8 to 16 ng/mL (using a chromatographic method) or 10 to 20 ng/mL (using an immunoassay).
567754|NCT00086307|B4|Baseline|Total|Total of all reporting groups
567755|NCT00086307|B3|Baseline|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
567756|NCT00086307|B2|Baseline|Escitalopram|Patients receive escitalopram and placebo.
567757|NCT00086307|B1|Baseline|Pramipexole|Patients receive pramipexole and placebo.
567758|NCT00086307|P3|Participant Flow|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
567759|NCT00086307|P2|Participant Flow|Escitalopram|Patients receive escitalopram and placebo.
567760|NCT00086307|P1|Participant Flow|Pramipexole|Patients receive pramipexole and placebo.
567761|NCT00086307|O3|Outcome|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
567762|NCT00086307|O2|Outcome|Escitalopram|Patients receive escitalopram and placebo.
567763|NCT00086307|O1|Outcome|Pramipexole|Patients receive pramipexole and placebo.
567764|NCT00086307|E3|Reported Event|Escitalopram and Pramipexole|Patients receive escitalopram and pramipexole.
567765|NCT00086307|E2|Reported Event|Escitalopram|Patients receive escitalopram and placebo.
567766|NCT00086307|E1|Reported Event|Pramipexole|Patients receive pramipexole and placebo.
567767|NCT00086281|B16|Baseline|Total|Total of all reporting groups
567768|NCT00086281|B15|Baseline|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567769|NCT00086281|B14|Baseline|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567770|NCT00086281|B13|Baseline|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
567771|NCT00086281|B12|Baseline|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567772|NCT00086281|B11|Baseline|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567773|NCT00086281|B10|Baseline|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567774|NCT00086281|B9|Baseline|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567775|NCT00086281|B8|Baseline|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567776|NCT00086281|B7|Baseline|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567777|NCT00086281|B6|Baseline|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
567778|NCT00086281|B5|Baseline|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567779|NCT00086281|B4|Baseline|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567780|NCT00086281|B3|Baseline|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
567808|NCT00086190|B2|Baseline|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567809|NCT00086190|B1|Baseline|Paroxetine|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567782|NCT00086281|B1|Baseline|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567783|NCT00086281|P15|Participant Flow|X With M|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567784|NCT00086281|P14|Participant Flow|Xyrem|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567785|NCT00086281|P13|Participant Flow|Placebo|Placebo was given at bedtime and again 2.5 to 4 hours later
567786|NCT00086281|P12|Participant Flow|P Then X|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567787|NCT00086281|P11|Participant Flow|Z With P Then P Then X With M|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567788|NCT00086281|P10|Participant Flow|P Then X Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567789|NCT00086281|P9|Participant Flow|X With M Then X Then P Then Z With P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567790|NCT00086281|P8|Participant Flow|X Then X Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567791|NCT00086281|P7|Participant Flow|X Then Z With P Then P Then X With M|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567792|NCT00086281|P6|Participant Flow|X Then Z With P Then X With M Then P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later.
567793|NCT00086281|P5|Participant Flow|P Then X Then P Then X With M Then Z With P|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567794|NCT00086281|P4|Participant Flow|Z With P Then P Then X With M Then X|Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later.
567795|NCT00086281|P3|Participant Flow|X With M Then Z With P Then X Then P|Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Placebo was given at bedtime and again 2.5 to 4 hours later.
567796|NCT00086281|P2|Participant Flow|X Then X With M Then P Then Z With P|Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment); then Placebo was given at bedtime and again 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later.
567797|NCT00086281|P1|Participant Flow|P Then X Then Z With P Then X With M|Placebo was given at bedtime and again 2.5 to 4 hours later; then Xyrem 9 grams given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; then Zolpidem 10 mg + placebo were given at bedtime and placebo given 2.5 to 4 hours later; then Xyrem 9 g + modafinil 200 mg (Xyrem 9 g was given in a divided dose: 4.5 g at bedtime and 4.5 g given 2.5 to 4 hours later; modafinil was given at 8 am on the morning of Xyrem treatment).
567798|NCT00086281|O4|Outcome|Zolpidem + Placebo|Zolpidem + Placebo
567799|NCT00086281|O3|Outcome|Xyrem + Modafinil|Xyrem + Modafinil
567800|NCT00086281|O2|Outcome|Xyrem|Xyrem
567801|NCT00086281|O1|Outcome|Placebo|Placebo
567802|NCT00086281|E4|Reported Event|Z + P|Zolpidem + Placebo
567803|NCT00086281|E3|Reported Event|X + M|Xyrem + Modafinil
567804|NCT00086281|E2|Reported Event|Xyrem|Xyrem
567805|NCT00086281|E1|Reported Event|Placebo|Placebo
567806|NCT00086190|B4|Baseline|Total|Total of all reporting groups
567807|NCT00086190|B3|Baseline|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567814|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567815|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567816|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567817|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567818|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567819|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567820|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567821|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567822|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567823|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567824|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567825|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567826|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567827|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567828|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567829|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567830|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567831|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567832|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567833|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567834|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567835|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567836|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567837|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567838|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567839|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567840|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567841|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567842|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567843|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567844|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567845|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567846|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567847|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567848|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567849|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567850|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567851|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567852|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567853|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567854|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567855|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567856|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567857|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567858|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567859|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567860|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567861|NCT00086190|O3|Outcome|Placebo|Mean change in outcome measure from baseline for participants taking placebo.
567862|NCT00086190|O2|Outcome|Venlafaxine Extended Release|Mean change in outcome measure from baseline for participants taking venlafaxine ER.
567863|NCT00086190|O1|Outcome|Paroxetine|Mean change in outcome measure from baseline for participants taking paroxetine.
567864|NCT00086190|E3|Reported Event|Placebo|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567865|NCT00086190|E2|Reported Event|Venlafaxine Extended Release|Paroxetine and venlafaxine will be compared to placebo over 12 weeks.
567869|NCT00086047|B1|Baseline|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
567870|NCT00086047|P2|Participant Flow|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
567871|NCT00086047|P1|Participant Flow|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
567872|NCT00086047|O2|Outcome|Fibromyalgia Education|Consists of education about fibromyalgia and its management
567873|NCT00086047|O1|Outcome|Coping Skills Training|Consists of training in pain management skills using cognitive-behavioral therapy techniques
567874|NCT00086047|E2|Reported Event|Education|Patient will receive 8 weekly sessions of education about fibromyalgia syndrome.
567875|NCT00086047|E1|Reported Event|Coping Skills|Patients will receive 8 weeks of behavioral training in pain coping strategies
567876|NCT00085917|B3|Baseline|Total|Total of all reporting groups
567877|NCT00085917|B2|Baseline|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567878|NCT00085917|B1|Baseline|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567879|NCT00085917|P2|Participant Flow|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567880|NCT00085917|P1|Participant Flow|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567881|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567882|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567883|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567884|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567885|NCT00085917|O2|Outcome|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567886|NCT00085917|O1|Outcome|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567887|NCT00085917|E2|Reported Event|Pegasys Double Dose|"pegylated interferon alfa -2a 180 mcg/twice week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 4 weeks then pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg) for 44 weeks~- Total Treatment for 48 weeks"
567888|NCT00085917|E1|Reported Event|Pegasys Single Dose|"pegylated interferon alfa -2a 180 mcg/week and weight based Ribavirin (1000daily for weight<75kg, 1200mg daily for weight >75kg)~- Treatment for 48 weeks"
567889|NCT00085839|B3|Baseline|Total|Total of all reporting groups
567890|NCT00085839|B2|Baseline|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567891|NCT00085839|B1|Baseline|Erlotinib|Erlotinib 150 mg/day continuous therapy
567892|NCT00085839|P2|Participant Flow|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567893|NCT00085839|P1|Participant Flow|Erlotinib|Erlotinib 150 mg/day continuous therapy
567894|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567895|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
567896|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567897|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
567898|NCT00085839|O2|Outcome|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567899|NCT00085839|O1|Outcome|Erlotinib|Erlotinib 150 mg/day continuous therapy
567900|NCT00085839|E2|Reported Event|Standard Chemotherapy|Paclitaxel 200 mg/m^2 IV infusion over 3 hours and carboplatin AUC 6 mg/mL x min IV over 15 – 30 minutes, both given on Day 1 every 21 days for 4 cycles
567901|NCT00085839|E1|Reported Event|Erlotinib|Erlotinib 150 mg/day continuous therapy
567902|NCT00085709|B3|Baseline|Total|Total of all reporting groups
567903|NCT00085709|B2|Baseline|ARA-C+Daunomycin|ARA-C+Daunomycin
567904|NCT00085709|B1|Baseline|Ara-C+Daunomycin+Mylotarg|Ara-C+Daunomycin+Mylotarg
567905|NCT00085709|P2|Participant Flow|ARA-C+Daunomycin|Standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
567906|NCT00085709|P1|Participant Flow|Ara-C+Daunomycin+Mylotarg|Gemtuzumab (GO) added to the standard induction regimen of 7 days of Ara-C (cytosine arabinoside)and 3 days of daunomycin
567907|NCT00085709|O4|Outcome|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
567908|NCT00085709|O3|Outcome|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
567909|NCT00085709|O2|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
567910|NCT00085709|O1|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
567911|NCT00085709|O2|Outcome|Ara-C+Daunomycin+Mylotarg|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
567912|NCT00085709|O1|Outcome|Ara-C+Daunomycin|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
567913|NCT00085709|O2|Outcome|Post-consolidation Observation|Patients did not receive any post-consolidation therapy
567914|NCT00085709|O1|Outcome|Post-consolidation GO|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
567915|NCT00085709|E4|Reported Event|Post-consolidation G.O.|For patients who remain in CR without relapse, patients may receive up to 3 doses of G.O. 28 days apart.
567916|NCT00085709|E3|Reported Event|Ara-C Consolidation|For patients who achieved a CR during induction, patients may receive up to 3 28 day cycles of treatment with Ara-C consolidation. Patients who relapse from CR are taken off protocol consolidation treatment.
567917|NCT00085709|E2|Reported Event|Induction 7 + 3|A 21 day treatment cycle of Induction 7+3 with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission during the first cycle of treatment
567918|NCT00085709|E1|Reported Event|Induction 7 + 3 + G.O.|A 21 day treatment cycle of Induction 7+3+G.O. with a 2nd 21 day cycle of the same for patients who did not achieve a complete remission (CR) during the first cycle of treatment
567919|NCT00085644|B3|Baseline|Total|Total of all reporting groups
567920|NCT00085644|B2|Baseline|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
567921|NCT00085644|B1|Baseline|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
567922|NCT00085644|P3|Participant Flow|Any Adalimumab|40 mg every other week (eow), subcutaneous (SC)
567923|NCT00085644|P2|Participant Flow|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
567924|NCT00085644|P1|Participant Flow|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
567925|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567926|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567927|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567928|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567929|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567930|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567931|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567932|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567933|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567934|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567935|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567936|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567937|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567938|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567939|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567940|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567941|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567942|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567943|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567944|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567945|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567946|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567947|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567948|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567949|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567950|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567951|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567952|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567953|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567954|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567955|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567956|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567957|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567958|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567959|NCT00085644|O1|Outcome|Any Adalimumab|By Duration of Exposure to Adalimumab 40 mg every other week, subcutaneous
567960|NCT00085644|O1|Outcome|Any Adalimumab|By duration of exposure to adalimumab 40 mg every other week, subcutaneous
567961|NCT00085644|O2|Outcome|Placebo|Subjects on placebo treatment received SC injection of matched placebo every other week.
567962|NCT00085644|O1|Outcome|Adalimumab|Subjects on active treatment received SC injection of 40 mg adalimumab every other week.
567963|NCT00085644|E1|Reported Event|Any Adalimumab|By duration of exposure to any adalimumab 40 mg eow, subcutaneous
567964|NCT00085631|B1|Baseline|Overall Study|Due to integrity issues with the current data, baseline measurements of age and gender are reported for the entire cohort, rather than by treatment arm. Age and gender information were available in the current documentation for all 101 patients in this study.
567965|NCT00085631|P3|Participant Flow|Chemoradiation + Hyperthermia|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, together with hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
567966|NCT00085631|P2|Participant Flow|Chemoradiation|"Patients in this arm were randomized to receive cisplatin chemotherapy and radiation therapy, without hyperthermia therapy. Completed patients were those who had documented response or follow-up data in the current dataset."
567967|NCT00085631|P1|Participant Flow|Unavailable|"Unavailable refers to patients who were randomized into one of the two treatment groups, but whose assignment could not be deduced from the current data. Completed patients were those who had documented response or follow-up data in the current dataset."
567968|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year overall survival rate in this study.
567969|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year local recurrence-free survival rate in this study.
567970|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the 5-year failure-free survival rate in this study.
567971|NCT00085631|O1|Outcome|Overall Study|Due to integrity issues with the current documented data, results are not reported for the primary tumor response rate in this study.
567972|NCT00085631|E1|Reported Event|Overall Study|Patients from both arms were combined in adverse event reporting.
567973|NCT00085566|B4|Baseline|Total|Total of all reporting groups
567974|NCT00085566|B3|Baseline|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567975|NCT00085566|B2|Baseline|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567976|NCT00085566|B1|Baseline|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567977|NCT00085566|P3|Participant Flow|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567978|NCT00085566|P2|Participant Flow|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567979|NCT00085566|P1|Participant Flow|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567980|NCT00085566|O3|Outcome|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567981|NCT00085566|O2|Outcome|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567982|NCT00085566|O1|Outcome|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567983|NCT00085566|E3|Reported Event|RAD 001 70 mg|70 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567984|NCT00085566|E2|Reported Event|RAD 001 50 mg|50 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567985|NCT00085566|E1|Reported Event|RAD 001 30 mg|30 mg RAD 001 with Gefitinib in Patients with Glioblastoma Multiforme and Prostate Cancer
567986|NCT00085540|B3|Baseline|Total|Total of all reporting groups
567987|NCT00085540|B2|Baseline|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
567988|NCT00085540|B1|Baseline|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
567989|NCT00085540|P2|Participant Flow|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
567990|NCT00085540|P1|Participant Flow|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
567991|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
567992|NCT00085540|O1|Outcome|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
568124|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568125|NCT00084409|O2|Outcome|Placebo|
567993|NCT00085540|O1|Outcome|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
567994|NCT00085540|E2|Reported Event|Phase 2 Dose From Phase 1 - Romidepsin|"Patients receive FR901228 (romidepsin) as in phase I at dose level 1. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity~Romidepsin (depsipeptide): 13.3mg/m2~depsipeptide: Given IV"
567995|NCT00085540|E1|Reported Event|Phase 1 Dose Escalation - Romidepsin|"Patients receive FR901228 (romidepsin) IV over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Dose escalation two dose levels:~Romidepsin (depsipeptide): 13.3mg/m2 and 17.7mg/m2~Pharmacokinetics~depsipeptide: Given IV"
567996|NCT00085436|B1|Baseline|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
567997|NCT00085436|P1|Participant Flow|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
567998|NCT00085436|O1|Outcome|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
567999|NCT00085436|E1|Reported Event|Treatment|All patients will be treated with autologous peripheral blood mononuclear cell-derived dendritic cells (DC) loaded with autologous tumor lysate (termed DC vaccine) administered into inguinal lymph nodes via ultrasound guidance in addition to systemic IL-2 and IFNα-2a. Two cycles of induction IL-2/IFNα-2a followed by 3 cycles of maintenance IL-2 + IFNα-2a.
568000|NCT00085423|B1|Baseline|Lymphodepleting Chemotherapy + High Dose IL-2|intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). GM-CSF (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery.
568001|NCT00085423|P1|Participant Flow|Lymphodepleting Chemotherapy + High Dose Interleukin-2|"Lymphodepleting chemotherapy + high dose interleukin-2:~Intravenous cyclophosphamide (60 mg/kg, days 1 and 2) and fludarabine (25 mg/m(2), day 3 through 7) followed by two 5-day courses of intravenous high-dose bolus IL-2 (600,000 U/kg; days 8 through 12 and 21 through 25). Granulocyte-macrophage colony-stimulating factor, GM-CSF, (250 microg/m(2)/d beginning day 8) was given until granulocyte recovery."
568002|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
568003|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
568004|NCT00085423|O1|Outcome|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
568005|NCT00085423|E1|Reported Event|Group 1|all patients are treated with lymphodepleting chemotherapy and highdose IL-2 and GM-CSF.
568006|NCT00085293|B1|Baseline|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
568007|NCT00085293|P1|Participant Flow|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
568008|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
568009|NCT00085293|O1|Outcome|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
568126|NCT00084409|O1|Outcome|Iloprost|
568470|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568010|NCT00085293|E1|Reported Event|Treatment|"Decitabine intravenous (IV) over 1 hour on days 1-5 and 8-12 of weeks 1 and 2 (course 1). Week 3, Iodine I 131 (131I) scanning using thyrotropin alfa injections. Participants whose scan do not demonstrate iodine uptake continue suppressive thyroid hormone therapy but no further study therapy; these participants who do show uptake undergo thyroid hormone withdrawal on weeks 4-8 and second course of decitabine (as in course 1) on weeks 7 and 8, with 131I therapy on week 9.~Decitabine: Starting dose 6 mg/m^2 intravenously over 1 hour every day for 5 successive days for 2 weeks (10 doses), with possible second course.~Iodine I 131: Undergo thyrotropin-alfa stimulated radioactive iodine scan~Recombinant thyrotropin alfa: Undergo thyrotropin-alfa stimulated radioactive iodine scan"
568011|NCT00085254|B4|Baseline|Total|Total of all reporting groups
568012|NCT00085254|B3|Baseline|Arm 3 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568013|NCT00085254|B2|Baseline|Arm 2 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568014|NCT00085254|B1|Baseline|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568015|NCT00085254|P3|Participant Flow|Arm 3 - Phase II (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (2000mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide,Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568016|NCT00085254|P2|Participant Flow|Arm 2 - Phase II (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV (500mg) on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~cilengitide, Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568017|NCT00085254|P1|Participant Flow|Arm 1 (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568018|NCT00085254|O1|Outcome|Arm 4 (Overall Study)|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568019|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (2000mg)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568020|NCT00085254|O1|Outcome|Arm 1- Phase 2 (500mg)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568021|NCT00085254|O2|Outcome|Arm 2 - Phase 2 (Treatment 2)|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568022|NCT00085254|O1|Outcome|Arm 1 - Phase 2 (Treatment 1)|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568023|NCT00085254|O1|Outcome|Arm 1 - Safety Run In|"INITIATION COURSE: Patients receive cilengitide IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568024|NCT00085254|O3|Outcome|Arm 3 2000mg (Safety Run-In)|"INITIATION COURSE: Patients receive cilengitide 2000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
568025|NCT00085254|O2|Outcome|ARM 2 1000mg (Safety run-in)|"INITIATION COURSE: Patients receive cilengitide 1000 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 1000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
568026|NCT00085254|O1|Outcome|Arm 1 500mg (Safety Run In)|"INITIATION COURSE: Patients receive cilengitide 500 mg IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~Doses of cilengitide: 500mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies~DLT defined as: Known TMZ hematological toxicities will not be considered dose limiting.~Nonhematological toxicities Grades 3-4 severity (except nausea and vomiting without sufficient antiemetic prophylaxis)"
568027|NCT00085254|E3|Reported Event|Dose 2000|"INITIATION COURSE: Patients receive cilengitide (2000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568028|NCT00085254|E2|Reported Event|Dose 1000|"INITIATION COURSE: Patients receive cilengitide (1000mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (2000mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568127|NCT00084409|E2|Reported Event|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568029|NCT00085254|E1|Reported Event|Dose 500|"INITIATION COURSE: Patients receive cilengitide (500mg) IV over 1 hour on days 1 and 4. Treatment repeats weekly for 10 weeks. Patients also receive oral temozolomide and undergo radiotherapy one hour later on days 1-5 of weeks 1-6.~MAINTENANCE COURSES: Patients receive oral temozolomide once daily on days 1-5 in courses 1-6. Patients also receive cilengitide (500mg) IV on days 1, 4, 8, 11, 15, 18, 22, and 25. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Doses of cilengitide: 500mg, 1000mg and 2000mg~Temozolimide, Radiation Therapy, laboratory biomarker analysis, pharmacological study~cilengitide: Given IV~temozolomide: Given orally~radiation therapy: Undergo radiotherapy~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
568030|NCT00085202|B3|Baseline|Total|Total of all reporting groups
568031|NCT00085202|B2|Baseline|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
568032|NCT00085202|B1|Baseline|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
568033|NCT00085202|P2|Participant Flow|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
568034|NCT00085202|P1|Participant Flow|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
568035|NCT00085202|O4|Outcome|ERBB2 Negative & High Risk|14 participants who were ERBB2 negative and in the high risk group
568036|NCT00085202|O3|Outcome|ERBB2 Negative & Average Risk|31 participants who were ERBB2 negative and in the average risk group
568037|NCT00085202|O2|Outcome|ERBB2 Positive & High Risk|23 participants who were ERBB2 positive and in the high risk group
568038|NCT00085202|O1|Outcome|ERBB2 Positive & Average Risk|54 participants who were ERBB2 positive and in the average risk group.
568039|NCT00085202|O3|Outcome|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
568040|NCT00085202|O2|Outcome|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa. Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
568041|NCT00085202|O1|Outcome|Overall Study|Analysis included the first 122 participants with a diagnosis of medulloblastoma and with fresh tissue and ERBB2 protein assessments. Participants with a diagnosis of supratentorial primitive neuroectodermal tumor (PNET), PNET variants (ependymoblastoma, pineoblastoma, CNS neuroblastoma), or atypical teratoid rhabdoid tumor (ATRT) were not included in the analysis of ERBB2 tumors.
568042|NCT00085202|E2|Reported Event|High-Risk Group|Participants assigned to the high-risk arm were determined to have the presence of metastatic disease within the neuraxis (i.e., evidence of subarachnoid dissemination), OR presence of residual disease (≥1.5 cm^2) at the primary site after surgery.
568043|NCT00085202|E1|Reported Event|Average-Risk Group|Participants assigned to the average-risk arm had localized tumor without overt evidence of invasion beyond the posterior fossa (or supratentorial compartment for PNET's/ATRT). Participants with T4 disease met the following criteria: gross total resection defined as residual tumor or imaging abnormality whose size was <1.5 cm^2 on postoperative CT or MR images, no evidence of CNS or extraneural metastasis, and brain stem invasion by the tumor in the absence of imaging evidence of residual tumor (tumor size <1.5 cm^2).
568044|NCT00085098|B3|Baseline|Total|Total of all reporting groups
568045|NCT00085098|B2|Baseline|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
568046|NCT00085098|B1|Baseline|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
568085|NCT00084617|P1|Participant Flow|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
568086|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
568229|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568047|NCT00085098|P2|Participant Flow|Regimen B (Chemotherapy Plus Radiotherapy)|Courses 1,2:Patients (PTS) receive carboplatin IV over 1 hour on days 1-2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses. Within 3 weeks of completing chemotherapy, PTS with complete response (CR) undergo low-dose radiation therapy 5 days a week for 5 weeks. PTS with minimal residual disease (MRD), a PR, or stable disease (SD) receive chemotherapy courses 3,4. Courses 3,4:PTS receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2-3 and filgrastim (G-CSF) subcutaneous (SC) or IV on day 4 continuing until blood counts recover. Treatment repeats every 21 days for 2 courses. PTS achieving a CR or MRD proceed to reduced-dose radiotherapy. PTS with a partial response (PR), SD or progressive disease (PD) are restaged and may undergo standard radiation therapy as in regimen A.Reduced-dose radiation therapy: Within 6 weeks of starting course 4, PTS undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks.
568048|NCT00085098|P1|Participant Flow|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
568049|NCT00085098|O2|Outcome|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
568050|NCT00085098|O1|Outcome|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
568051|NCT00085098|E2|Reported Event|Regimen B (Chemotherapy Plus Radiotherapy)|"Courses 1 and 2: Patients receive carboplatin IV over 1 hour on days 1 and 2 and etoposide IV over 2 hours on days 1-3. Treatment repeats every 21 days for 2 courses.~Within 3 weeks of completing chemotherapy, patients with CR undergo low-dose radiation therapy 5 days a week for 5 weeks. Patients with MRD, a PR, or SD receive chemotherapy courses 3 and 4 as outlined below.~Courses 3 and 4: Patients receive cisplatin IV over 6 hours on day 1, cyclophosphamide IV over 1 hour on days 2 and 3, and filgrastim (G-CSF) SC or IV beginning on day 4 and continuing until blood counts recover.~Treatment repeats every 21 days for 2 courses. Patients achieving a CR or MRD proceed to reduced-dose radiotherapy. Patients with a PR, SD, or PD are restaged and may undergo standard radiation therapy as in regimen A.~Reduced-dose radiation therapy: Within 6 weeks of starting course 4, patients undergo lower-dose radiation therapy once daily on days 1-5 for 5 weeks"
568052|NCT00085098|E1|Reported Event|Regimen A (Radiotherapy Only)|Within 52 days of surgery, patients will undergo standard-dose radiation therapy 5 days a week for approximately 5-6 weeks.
568053|NCT00084838|B1|Baseline|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568054|NCT00084838|P1|Participant Flow|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568055|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568087|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
568088|NCT00084617|O1|Outcome|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
568230|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568056|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568057|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568058|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568059|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568060|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568061|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568062|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568122|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568277|NCT00083889|O1|Outcome|SU012662|Active metabolite of SU011248
568063|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568064|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568065|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568066|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568067|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568068|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568069|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568123|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
569133|NCT00078325|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
568070|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively.~filgrastim"
568071|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Mod IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51)~Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568072|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568073|NCT00084838|O1|Outcome|Multi-agent Intrathecal and Systemic CT With RT (Modified IRS|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine, and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568074|NCT00084838|E1|Reported Event|Multi-agent Intrathecal & Systemic CT w/ RT (Modified IRS III)|"Pre-irradiation induction therapy (wks 1-6); Chemoradiation induction therapy (wks 7-12); Post-radiation induction therapy (wks 13-18); Maintenance therapy (wks 19-44); Continuation therapy (wks 45-51) Induction Chemotherapy: CT backbone of the IRS-III regimen [vincristine, dactinomycin, cyclophosphamide (specifically, in combination), cisplatin, doxorubicin, and imidazole carboximide (DTIC)] was modified to incl temozolomide in lieu of DTIC. Pts w/ M0 dz (and initially positive CSF cytology) rcvd intrathecal (IT) CT (alt btwn intralumbar and intraventricular routes) w/ methotrexate, cytarabine,and hydrocortisone, coinciding with a cycle of CT.~Radiation Therapy: Pts w/ M0 dz OR M+ dz aged <3y received focal RT (3D conformal or intensity-modulated delivery). Pts >3y w/ M+ dz rcvd craniospinal irradiation.~Continuation Therapy: Pts treated with either non-doxorubicin or doxorubicin dose therapy if receiving CSI or mediastinal radiotherapy or not, respectively."
568075|NCT00084747|B1|Baseline|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
568076|NCT00084747|P1|Participant Flow|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
568077|NCT00084747|O1|Outcome|Bortezomib|bortezomib
568078|NCT00084747|O1|Outcome|Bortezomib|autologous peripheral blood progenitor cell transplantation with bortezomib maintenance as treatment for intermediate-and advanced-stage multiple myeloma
568079|NCT00084747|E1|Reported Event|Bortezomib|bortezomib administration beginning 3-4 month after the day of transplantation after resolution of bone marrow transplant toxicities
568080|NCT00084682|B1|Baseline|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
568081|NCT00084682|P1|Participant Flow|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
568082|NCT00084682|O1|Outcome|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
568083|NCT00084682|E1|Reported Event|Treatment (Romidepsin)|"Patients receive FR901228 (depsipeptide) IV at 13 mg/m2 over 4 hours on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~romidepsin: Given IV"
568084|NCT00084617|B1|Baseline|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
569134|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
568089|NCT00084617|E1|Reported Event|Treatment (Oxaliplatin, Irinotecan, Capecitabine)|Patients receive oxaliplatin IV over 2 hours and irinotecan IV over 30 minutes on days 1, 8, 15, and 22 and oral capecitabine twice daily on days 1-5, 8-12, 15-19, and 22-26. Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity.
568090|NCT00084487|B1|Baseline|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568091|NCT00084487|P1|Participant Flow|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568092|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568093|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568094|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568095|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568096|NCT00084487|O1|Outcome|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568097|NCT00084487|E1|Reported Event|Treatment (Rebeccamycin Analogue)|"Patients receive rebeccamycin analogue IV over 1 hour on days 1-5. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity.~becatecarin : Given IV"
568098|NCT00084409|B3|Baseline|Total|Total of all reporting groups
568099|NCT00084409|B2|Baseline|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568100|NCT00084409|B1|Baseline|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568101|NCT00084409|P2|Participant Flow|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568102|NCT00084409|P1|Participant Flow|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568103|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568104|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568105|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568106|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568107|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568108|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568109|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568110|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568111|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568112|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568113|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568114|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568115|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568116|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568117|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568118|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568119|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568120|NCT00084409|O1|Outcome|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568121|NCT00084409|O2|Outcome|Placebo|Patients receive oral placebo twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568340|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568128|NCT00084409|E1|Reported Event|Iloprost|Patients receive oral iloprost twice daily for 6 months in the absence of unacceptable toxicity.This group consisted of current and former smokers.
568129|NCT00084383|B1|Baseline|GVAX Pancreatic Cancer Vaccine|
568130|NCT00084383|P1|Participant Flow|GVAX Pancreatic Cancer Vaccine|
568131|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
568132|NCT00084383|O1|Outcome|GVAX Pancreatic Cancer Vaccine|
568133|NCT00084383|E1|Reported Event|GVAX Pancreatic Cancer Vaccine|
568134|NCT00084318|B3|Baseline|Total|Total of all reporting groups
568135|NCT00084318|B2|Baseline|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568136|NCT00084318|B1|Baseline|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568137|NCT00084318|P2|Participant Flow|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568138|NCT00084318|P1|Participant Flow|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568139|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568140|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568141|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568142|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568143|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568144|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568145|NCT00084318|O2|Outcome|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568146|NCT00084318|O1|Outcome|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568147|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568148|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568149|NCT00084318|O2|Outcome|RT + Docetaxel + Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568150|NCT00084318|O1|Outcome|RT + Cisplatin + Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568151|NCT00084318|E2|Reported Event|RT+Docetaxel+Cetuximab|Loading dose of cetuximab followed by radiation therapy (RT) with weekly docetaxel and cetuximab.
568152|NCT00084318|E1|Reported Event|RT+Cisplatin+Cetuximab|Loading dose of cetuximab followed by radiation therapy with weekly cisplatin and cetuximab.
568153|NCT00084266|B3|Baseline|Total|Total of all reporting groups
568154|NCT00084266|B2|Baseline|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568155|NCT00084266|B1|Baseline|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568156|NCT00084266|P2|Participant Flow|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568157|NCT00084266|P1|Participant Flow|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568158|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568159|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568160|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568161|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568162|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568163|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568164|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568165|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568166|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568167|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568168|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568169|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568170|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568171|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568172|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568173|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568174|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568175|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568176|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568177|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568178|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568179|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568180|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568181|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568182|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568183|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568184|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568185|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568186|NCT00084266|O2|Outcome|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568341|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568187|NCT00084266|O1|Outcome|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568188|NCT00084266|E2|Reported Event|Vancomycin|Vancomycin IV approximately every 12 hours (twice daily) at a dose of 30 mg/kg/day in 2 divided doses (15 mg/kg/dose) over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568189|NCT00084266|E1|Reported Event|Linezolid|Linezolid intravenous (IV) approximately every 12 hours (twice daily) at a dose of 600 milligrams (mg) infused over a period of 60-120 minutes for 7 to 14 days except in cases of documented bacteremia where it could be extended to 21 days based upon investigator’s discretion.
568190|NCT00084136|B4|Baseline|Total|Total of all reporting groups
568191|NCT00084136|B3|Baseline|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568192|NCT00084136|B2|Baseline|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
568193|NCT00084136|B1|Baseline|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568194|NCT00084136|P3|Participant Flow|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568195|NCT00084136|P2|Participant Flow|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
568196|NCT00084136|P1|Participant Flow|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568197|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568198|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568199|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568200|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568201|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568202|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568203|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568204|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568205|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568206|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568207|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568208|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568209|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568210|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568211|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568212|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568213|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568214|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568215|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568216|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568217|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568218|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568219|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568220|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568221|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568222|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568223|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568224|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568225|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568226|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568227|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568228|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568231|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
568232|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568233|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568234|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568235|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568236|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568237|NCT00084136|O2|Outcome|ddI+FTC+ATV|"ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine >~> On May 23, 2008, Arm B was closed following a planned interim review by the study's independent Data and Safety Monitoring Board (DSMB). The DSMB recommendation was based upon compelling evidence that Arm B had significantly more virologic failure (and therefore was inferior when) compared to Arm A. Participants still receiving Arm B medications were offered alternatives, and all participants continued to be followed."
568238|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568239|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568240|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568241|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568242|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568243|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568244|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568245|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568246|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568247|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568248|NCT00084136|O3|Outcome|TDF/FTC+EFV|TDF/FTC+EFV participants will receive emtricitabine/tenofovir disoproxil fumarate and efavirenz
568249|NCT00084136|O2|Outcome|ddI+FTC+ATV|ddI+FTC+ATV participants will receive emtricitabine, atazanavir, and enteric-coated didanosine
568250|NCT00084136|O1|Outcome|ZDV/3TC+EFV|ZDV/3TC+EFV participants will receive lamivudine/zidovudine and efavirenz
568251|NCT00084136|E3|Reported Event|TDF/FTC+EFV|
568252|NCT00084136|E2|Reported Event|ddI+FTC+ATV|
568253|NCT00084136|E1|Reported Event|ZDV/3TC+EFV|
568254|NCT00084084|B1|Baseline|Agalsidase Alfa (Cohort 1)|0.2 mg/kg agalsidase alfa infused by IV over 40 (+/- 10) minutes every other week
568255|NCT00084084|P1|Participant Flow|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
568256|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
568257|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
568258|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
568259|NCT00084084|O1|Outcome|Agalsidase Alfa (Cohort 1)|Cohort 1 was composed of patients who had completed TKT023. Patients received 0.2 mg/kg agalsidase alfa, IV, every other week.
568260|NCT00084084|E2|Reported Event|Transition Safety Population|A subset of patients from the Safety Population RB who additionally received at least 1 dose of Replagal AF in Phase 2.
568261|NCT00084084|E1|Reported Event|Safety Population RB|Patients in Cohort 1 who received at least 1 dose of Replagal RB in Phase 1 - no data from Phase 2 (Replagal AF) included.
568262|NCT00083915|B3|Baseline|Total|Total of all reporting groups
568263|NCT00083915|B2|Baseline|Mel-DT PACE|
568264|NCT00083915|B1|Baseline|High Dose Melphalan|
568265|NCT00083915|P2|Participant Flow|Mel-DT PACE|
568266|NCT00083915|P1|Participant Flow|High Dose Melphalan|
568267|NCT00083915|O2|Outcome|Mel-DT PACE|
568268|NCT00083915|O1|Outcome|High Dose Melphalan|
568269|NCT00083915|E2|Reported Event|Mel-DT PACE|
568270|NCT00083915|E1|Reported Event|High Dose Melphalan|
568271|NCT00083889|B3|Baseline|Total|Total of all reporting groups
568272|NCT00083889|B2|Baseline|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568273|NCT00083889|B1|Baseline|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568274|NCT00083889|P2|Participant Flow|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568275|NCT00083889|P1|Participant Flow|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568276|NCT00083889|O1|Outcome|Total Drug: SU011248 and SU012662|SU011248 and active metabolite SU012662
568278|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle. Intra-subject dose reduction to 35.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568279|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568280|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568281|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568282|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568283|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568284|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568285|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568286|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568287|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568288|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568289|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568290|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568291|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568292|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568293|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568294|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568295|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568296|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568297|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568298|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568299|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568300|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568301|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568302|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568303|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568342|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
569135|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568304|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568305|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568306|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568307|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568308|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568309|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568310|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568311|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568312|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568313|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568314|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568315|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568316|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568317|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568318|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568319|NCT00083889|O2|Outcome|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568320|NCT00083889|O1|Outcome|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568321|NCT00083889|E2|Reported Event|IFN-α|Subcutaneous (SC) injection in 6-week cycles on 3 non-consecutive days per week; 3 million units (MU) per dose Week 1; 6 MU per dose Week 2; 9 MU per dose Week 3 until completion of therapy or development of toxicity.
568322|NCT00083889|E1|Reported Event|SU011248|50 mg taken orally once a day for 4 weeks followed by a 2-week off treatment cycle to form a 6-week treatment cycle. Intra-subject dose reduction to 37.5 mg/day and 25 mg/day was allowed depending on type and severity of toxicity encountered.
568323|NCT00083759|B3|Baseline|Total|Total of all reporting groups
568324|NCT00083759|B2|Baseline|Placebo|Placebo IV infusions + methotrexate (MTX)
568325|NCT00083759|B1|Baseline|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
568326|NCT00083759|P2|Participant Flow|Placebo|Placebo IV infusions + methotrexate (MTX)
568327|NCT00083759|P1|Participant Flow|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
568328|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
568329|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
568330|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
568331|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
568332|NCT00083759|O2|Outcome|Placebo|Placebo IV infusions + methotrexate (MTX)
568333|NCT00083759|O1|Outcome|Natalizumab|Natalizumab 300 mg as monthly IV infusions + methotrexate (MTX)
568334|NCT00083720|B1|Baseline|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568335|NCT00083720|P1|Participant Flow|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568336|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568337|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568338|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568339|NCT00083720|O1|Outcome|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568343|NCT00083720|E1|Reported Event|Cetuximab|Initial dose of 400 mg/m2 i.v. over 120 minutes, followed by 250 mg/m2 weekly i.v. over 60 minutes
568344|NCT00083616|B1|Baseline|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568345|NCT00083616|P1|Participant Flow|Panitumumab (ABX-EGF)|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568346|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568347|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568348|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568349|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568350|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568351|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568352|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568353|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568354|NCT00083616|O1|Outcome|Panitumumab|Open-label panitumumab administered by intravenous (IV) infusion at a dose of 6 mg/kg given once every 2 weeks until participants developed progressive disease, were unable to tolerate panitumumab, or discontinued treatment for other reasons.
568355|NCT00083616|E1|Reported Event|Panitumumab|
568356|NCT00083551|B3|Baseline|Total|Total of all reporting groups
568357|NCT00083551|B2|Baseline|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
568358|NCT00083551|B1|Baseline|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
568359|NCT00083551|P2|Participant Flow|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
568360|NCT00083551|P1|Participant Flow|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
568361|NCT00083551|O2|Outcome|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
568362|NCT00083551|O1|Outcome|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
568363|NCT00083551|E2|Reported Event|No Thalidomide|Patient received no thalidomide during induction, consolidation, and maintenance therapy.
568364|NCT00083551|E1|Reported Event|Thalidomide|Thalidomide 400 QD during induction, 100 mg QD between transplants, 200 mg QD post transplant, 100 mg QD during year one of maintenance, and 50 mg QD during second year of maintenance.
568365|NCT00083382|B1|Baseline|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
568366|NCT00083382|P1|Participant Flow|Thalidomide + Bisphosphonate|"200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy~Thalidomide: All Patients will receive thalidomide 200 mg as an oral once daily dose. Dose may be reduced to as low as 50 mg qod in the event of severe toxicity. Thalidomide will continue daily as tolerated until criteria to remove from study are met. Patients will receive appropriate regimen to prevent constipation (i.e., colace, dulcolax, milk of magnesia, or lactulose)~Pamidronate: Patients will receive either pamidronate or zometa. Pamidronate is administered at a dose of 90 mg by continuous infusion over 90 minutes, every two weeks for 2 months. Disease will be reassessed after two cycles. Those with stable disease or better will receive 90 mg every 4 weeks as maintenance therapy.~Zometa: Patients will receive either pamidronate or zometa. Zometa is administered at a dose of 4 mg by continuous infusion every two weeks for 2 months. Dise"
568367|NCT00083382|O1|Outcome|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
568368|NCT00083382|E1|Reported Event|Thalidomide + Bisphosphonate|200 mg/day Thalidomide + 90 mg Pamidronate OR 4 mg Zometa every 2 weeks for 2 months and then every 4 weeks as maintenance therapy
568369|NCT00083226|B1|Baseline|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
568409|NCT00082888|P1|Participant Flow|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
568370|NCT00083226|P1|Participant Flow|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
568371|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
568372|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
568373|NCT00083226|O1|Outcome|Treatment (Doxorubicin+Bortezomib)|"Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity. Patients with no disease progression may continue to receive bortezomib alone in the absence of disease progression or unacceptable toxicity.~doxorubicin: Given IV~bortezomib: Given IV"
568374|NCT00083226|E1|Reported Event|Doxorubicin+Bortezomib|Patients receive doxorubicin IV over 5-15 minutes on days 1 and 8. Patients also receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11.
568375|NCT00083174|B3|Baseline|Total|Total of all reporting groups
568376|NCT00083174|B2|Baseline|Placebo|one tablet daily in am
568377|NCT00083174|B1|Baseline|Exemestane|one 25 mg tablet daily in am
568378|NCT00083174|P2|Participant Flow|Placebo|one tablet daily in am
568379|NCT00083174|P1|Participant Flow|Exemestane|one 25 mg tablet daily in am
568380|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568381|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568382|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568383|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568384|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568385|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568386|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568387|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568388|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568389|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568390|NCT00083174|O2|Outcome|Placebo|one tablet daily in am
568391|NCT00083174|O1|Outcome|Exemestane|one 25 mg tablet daily in am
568392|NCT00083174|O2|Outcome|Placebo|Placebo tablet daily
568393|NCT00083174|O1|Outcome|Exemestane|25 mg of exemestane tablet daily
568394|NCT00083174|E2|Reported Event|Placebo|one tablet daily in am
568395|NCT00083174|E1|Reported Event|Exemestane|one 25 mg tablet daily in am
568396|NCT00083122|B3|Baseline|Total|Total of all reporting groups
568397|NCT00083122|B2|Baseline|Group 2 (Platin Sensitive)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568398|NCT00083122|B1|Baseline|Group 1 (Platin Resistant)|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568399|NCT00083122|P2|Participant Flow|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568400|NCT00083122|P1|Participant Flow|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 of cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568401|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568402|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568403|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568404|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568405|NCT00083122|O2|Outcome|Group 2 (Platin Sensitive)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568406|NCT00083122|O1|Outcome|Group 1 (Platin Resistant)|Patients receive 60 mg/m^2 cisplatin IV over 2 hours and 100 mg/m^2 flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568407|NCT00083122|E1|Reported Event|Group 1 and Group 2 Combined|Patients receive cisplatin IV over 2 hours and flavopiridol IV over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
568408|NCT00082888|B1|Baseline|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
568468|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568410|NCT00082888|O1|Outcome|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
568411|NCT00082888|E1|Reported Event|R115777 (Tipifarnib)|300mg twice a day for 21 days. Cycle length is 28 days. After cycle 1, may increase the dose to 400mg twice a day or 600mg twice a day at physician dicretion.
568412|NCT00082810|B1|Baseline|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568413|NCT00082810|P1|Participant Flow|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568414|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568415|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568416|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568417|NCT00082810|O1|Outcome|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568418|NCT00082810|E1|Reported Event|Fulvestrant 250 mg + Tipifarnib 300 mg|Patients receive fulvestrant 250 mg intramuscularly on day 1 and oral tipifarnib 300 mg twice daily on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
568419|NCT00082758|B4|Baseline|Total|Total of all reporting groups
568420|NCT00082758|B3|Baseline|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
568421|NCT00082758|B2|Baseline|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
568422|NCT00082758|B1|Baseline|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
568423|NCT00082758|P3|Participant Flow|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by meta-iodobenzylguanidine (MIBG) scanning or bone marrow (BM) histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
568424|NCT00082758|P2|Participant Flow|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by meta-iodobenzylguanidine (MIBG) scanning and/or by bone marrow (BM) histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
568425|NCT00082758|P1|Participant Flow|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
568426|NCT00082758|O3|Outcome|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells)~hu14.18-Interleukin-2 fusion protein : Given IV"
568427|NCT00082758|O2|Outcome|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
568428|NCT00082758|O1|Outcome|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
568429|NCT00082758|E3|Reported Event|Disease Identified by BM Immunohistochemistry Only|"Patients with residual/refractory neuroblastoma that do not have disease that is measurable by standard radiographic techniques or evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning or BM histology, however, disease is identified and quantified by BM immunohistochemistry (>5 neuroblastoma cells per 1,000,000 nucleated marrow cells).~hu14.18-Interleukin-2 fusion protein : Given IV"
568430|NCT00082758|E2|Reported Event|Disease Eval by MIBG or BM Histology (hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma with disease that is not measurable by standard radiographic criteria, but is evaluable by MIBG (iodine-131-meta-iodobenzylguanidine) scanning and/or by bone marrow histology.~hu14.18-Interleukin-2 fusion protein : Given IV"
568469|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568431|NCT00082758|E1|Reported Event|Disease Measurable by Standard Criteria(hu14.18-interleukin-2)|"Patients with residual/refractory neuroblastoma and readily measurable residual/refractory disease using standard radiographic criteria. Standard radiographic criteria for CT/MRI Lesions will use the definitions of measurable disease from the Response Evaluation Criteria In Solid Tumors (RECIST) from the National Cancer Institute.~hu14.18-Interleukin-2 fusion protein : Given IV"
568432|NCT00082433|B3|Baseline|Total|Total of all reporting groups
568433|NCT00082433|B2|Baseline|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568434|NCT00082433|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568435|NCT00082433|P2|Participant Flow|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568436|NCT00082433|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568437|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568438|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568439|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568440|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568441|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568442|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568443|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568444|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568445|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568446|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568447|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568448|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568449|NCT00082433|O2|Outcome|Capecitabine|Capecitabine alone: Capecitabine 1250 mg/m2 BID (2500 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568450|NCT00082433|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568451|NCT00082433|E2|Reported Event|Ixabepilone + Capecitabine|
568452|NCT00082433|E1|Reported Event|Capecitabine|
568453|NCT00082407|B3|Baseline|Total|Total of all reporting groups
568454|NCT00082407|B2|Baseline|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568455|NCT00082407|B1|Baseline|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568456|NCT00082407|P2|Participant Flow|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568457|NCT00082407|P1|Participant Flow|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568458|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568459|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568460|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568461|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568462|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568463|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568464|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568465|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568466|NCT00082407|O2|Outcome|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568467|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568471|NCT00082407|O1|Outcome|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568472|NCT00082407|E2|Reported Event|Biphasic Insulin Aspart Arm|subcutaneous injection, twice daily; titration to target blood glucose level
568473|NCT00082407|E1|Reported Event|Exenatide Arm|subcutaneous injection, twice daily; 5 mcg for 4 weeks followed by 10 mcg for 48 weeks
568474|NCT00082381|B3|Baseline|Total|Total of all reporting groups
568475|NCT00082381|B2|Baseline|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568476|NCT00082381|B1|Baseline|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568477|NCT00082381|P2|Participant Flow|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568478|NCT00082381|P1|Participant Flow|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568479|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568480|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568481|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568482|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568483|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568484|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568485|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568486|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568487|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568488|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568489|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568490|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568491|NCT00082381|O2|Outcome|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568492|NCT00082381|O1|Outcome|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568493|NCT00082381|E2|Reported Event|Insulin Glargine Arm|Insulin glargine subcutaneous injection once daily for 26 weeks (forced titration to target blood glucose level)
568494|NCT00082381|E1|Reported Event|Exenatide Arm|Exenatide subcutaneous injection twice daily for 26 weeks (5mcg for 4 weeks followed by 10mcg for 22 weeks)
568495|NCT00082368|B1|Baseline|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
568496|NCT00082368|P1|Participant Flow|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
568497|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
568498|NCT00082368|O1|Outcome|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
568499|NCT00082368|E1|Reported Event|PET Imaging With Tc-94m Sestamibi|"PET sestamibi scans followed by tariquidar and repeat imaging~Tariquidar: 3 days after initial PET patients will receive tariquidar and repeat imaging.~Tc-94m Sestamibi: Patients over 18 years of age, who are eligible for, or have completed enrollment in an active NCI protocol for treatment of cancer will undergo a PET sestamibi scan"
568500|NCT00082355|B1|Baseline|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
568501|NCT00082355|P1|Participant Flow|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
568502|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
568539|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
568540|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
568503|NCT00082355|O1|Outcome|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
568504|NCT00082355|E1|Reported Event|Alteplase|Dose of Alteplase will not exceed 10 mg/d/leg and is delivered in a concentration of 100ug/mL. The actual dose delivered is based upon the length of the thrombosed vein and 1 mL is injected directly into each centimeter of a thrombosed vein in a lower extremity. The treatment will be repeated up to 4 times over a 5 day period.
568505|NCT00082342|B3|Baseline|Total|Total of all reporting groups
568506|NCT00082342|B2|Baseline|Sham tDCS|Subjects received sham transcranial direct current stimulation
568507|NCT00082342|B1|Baseline|Real tDCS|Subjects received real transcranial direct current stimulation
568508|NCT00082342|P2|Participant Flow|Sham tDCS|"Subjects receiving sham transcranial direct current stimulation, had electrodes placed on the subjects head in a manner which caused a temporary tingling sensation without effects on the brain. Subjects receiving sham transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication."
568509|NCT00082342|P1|Participant Flow|Real tDCS|"Transcranial direct current stimulation (tDCS) is a method of non-invasive brain stimulation whereby a direct current is applied to the brain via surface electrodes on the head for a specified time period. It is a form of neurostimulation. Subjects receiving real transcranial direct current stimulation underwent 8 sessions during a 2 1/2 week period while on medication. A battery driven stimulator, Phoresor II Model PM850 delivered the tDCS through electrodes."
568510|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving sham tDCS.
568511|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Bradykinesia measured in the hands and arms while off medication and receiving real tDCS.
568512|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving sham tDCS.
568513|NCT00082342|O1|Outcome|Real tDCS While on Medication|Bradykinesia measured in the hands and arms while on medication and receiving real tDCS.
568514|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The motor UPDRS score off medication while receiving sham tDCS
568515|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The motor UPDRS score off medication while receiving real tDCS
568516|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The motor UPDRS score on medication while receiving sham tDCS
568517|NCT00082342|O1|Outcome|Real tDCS While on Medication|The motor UPDRS score on medication while receiving real tDCS
568518|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|The total UPDRS score off medication while receiving sham tDCS
568519|NCT00082342|O3|Outcome|Real tDCS While Off Medication|The total UPDRS score off medication while receiving real tDCS
568520|NCT00082342|O2|Outcome|Sham tDCS While on Medication|The total UPDRS score on medication while receiving sham tDCS
568521|NCT00082342|O1|Outcome|Real tDCS While on Medication|The total UPDRS score on medication while receiving real tDCS
568522|NCT00082342|O4|Outcome|Sham tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
568523|NCT00082342|O3|Outcome|Real tDCS While Off Medication|Timed gait during 10m walking task in subjects off medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
568524|NCT00082342|O2|Outcome|Sham tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post sham tDCS, one month post sham tDCS, three month post sham tDCS.
568525|NCT00082342|O1|Outcome|Real tDCS While on Medication|Timed gait during 10m walking task in subjects on medication at baseline, one day post tDCS, one month post tDCS, three month post tDCS.
568526|NCT00082342|E2|Reported Event|Sham tDCS|Subjects received sham transcranial direct current stimulation
568527|NCT00082342|E1|Reported Event|Real tDCS|Subjects received real transcranial direct current stimulation
568528|NCT00082329|B1|Baseline|AMD 3100 (Mozobil Plerixafor)|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~AMD 3100 (Mozobil plerixafor) : Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis"
568529|NCT00082329|P1|Participant Flow|AMD 3100 (Mozobil Plerixafor)|Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis
568530|NCT00082329|O1|Outcome|AMD 3100 and G-CSF Responders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
568531|NCT00082329|E1|Reported Event|AMD 3100 & G-CSF Respnders|"Healthy volunteers will be administered AMD 3100 (Mozobil plerixafor) and granulocyte colony stimulating factor (G-CSF) to determine cytokine polarization status of cluster of differentiation (CD 4) T-cells collected by apheresis~We propose that the combination of single dose AMD 3100 and G-CSF as combined mobilizing agents will improve the peripheral blood progenitor cells mobilization as compared to G-CSF mobilization."
568532|NCT00082173|B3|Baseline|Total|Total of all reporting groups
568533|NCT00082173|B2|Baseline|Control Arm (EMB)|
568534|NCT00082173|B1|Baseline|Experimental Arm (Moxi)|
568535|NCT00082173|P2|Participant Flow|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
568536|NCT00082173|P1|Participant Flow|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
568537|NCT00082173|O2|Outcome|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
568538|NCT00082173|O1|Outcome|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
568541|NCT00082173|E2|Reported Event|Control Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX placebo/EMB 15-20mg/kg once daily for 8 weeks
568542|NCT00082173|E1|Reported Event|Experimental Arm|INH 300mg/RIF 600mg/PZA 20mg/kg/MOX 400mg/EMB placebo once daily for 8 weeks
568543|NCT00082017|B1|Baseline|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
568544|NCT00082017|P2|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|"Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
568545|NCT00082017|P1|Participant Flow|UCN-01 for T-cell Lymphomas - Cohort 1-Every 28 Days|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days."
568546|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
568547|NCT00082017|O2|Outcome|UCN-01 for T-cell Lymphomas - Cohort 2 Every 21 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days.
568548|NCT00082017|O1|Outcome|UCN-01 for T-cell Lymphomas - Cohort 1 Every 28 Days|Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2 Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2. Repeat cycles every 28 days.
568549|NCT00082017|E1|Reported Event|UCN-01 for T-cell Lymphomas - Cohort 1&2|"Cohort 1 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 28 days.~Cohort 2 Cycle 1: 45 mg/m^2/day continuous intravenous infusion 1 to 3 days (72 hours) for total dose of 135 mg/m^2~Cycle 2: 45 mg/m^2/day continuous intravenous infusion 1 to 2 days (36 hours) for total dose of 68 mg/m^2; Repeat cycles every 21 days."
568550|NCT00081939|B1|Baseline|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
568551|NCT00081939|P1|Participant Flow|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
568552|NCT00081939|O1|Outcome|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
568553|NCT00081939|E1|Reported Event|Study Treatment|Two cycles of VDTPACE induction (Velcade days 1, 4, 8, and 11; DTPACE days 4-7) with interim thalidomide (50 mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle. Induction followed by single or tandem MEL200 transplant (MEL140 mg/m2 for subjects > 70 years of age) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each transplant. Transplants followed by two cycles of VDTPACE consolidation (Velcade days 1, 4, 8, and 11; DTPACE days 1-4) with interim thalidomide (100mg QD) + Dex (20 mg QD x 4 days every 21 days) following each cycle of VDTPACE. Consolidation followed by 3 years of maintenance therapy with VDT (velcade 1.0 mg/m2 days 1, 4, 8, 11 q 28 days; Thal 100 mg QD; and Dex 20mg days 1-4 and 8-11 q 28 days) during Year 1 and TD (Thal 100 mg QD and Dex 20 mg days 1-4, q 28 days) or VTD (velcade 1.0 mg/m2 weekly, Thal 100 mg QD, and Dex 20 mg weekly) during Years 2 and 3.
568554|NCT00081861|B1|Baseline|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
568555|NCT00081861|P1|Participant Flow|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
568556|NCT00081861|O1|Outcome|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
568557|NCT00081861|E1|Reported Event|Avastin + Rituximab|Avastin 10 mg/kg given intravenously every 2 weeks for 4 doses, and Rituximab 375 mg/m^2 intravenously weekly for 8 doses.
568558|NCT00081770|B4|Baseline|Total|Total of all reporting groups
568559|NCT00081770|B3|Baseline|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568560|NCT00081770|B2|Baseline|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568561|NCT00081770|B1|Baseline|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568562|NCT00081770|P3|Participant Flow|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568563|NCT00081770|P2|Participant Flow|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568564|NCT00081770|P1|Participant Flow|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568565|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568566|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568567|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568568|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568569|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568570|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568571|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568572|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568573|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568574|NCT00081770|O3|Outcome|PEGASYS 180 ug/wk Plus COPEGUS|PEGASYS (peginterferon alfa-2a) 180 ug/week plus COPEGUS (ribavirin) 1000-1200 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568575|NCT00081770|O2|Outcome|PegIntron 1.0 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.0 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568576|NCT00081770|O1|Outcome|PegIntron 1.5 ug/kg/wk Plus REBETOL|PegIntron (peginterferon alfa-2b; SCH 54031) 1.5 ug/kg/week in combination with weight-based REBETOL (ribavirin; SCH 18908) 800-1400 mg/day administered for 48 weeks with 24-week post-treatment follow-up
568577|NCT00081770|E3|Reported Event|PEGASYS 180 ug/wk Plus COPEGUS|
568578|NCT00081770|E2|Reported Event|PegIntron 1.0 ug/kg/wk Plus REBETOL|
568579|NCT00081770|E1|Reported Event|PegIntron 1.5 ug/kg/wk Plus REBETOL|
568580|NCT00081731|B3|Baseline|Total|Total of all reporting groups
568581|NCT00081731|B2|Baseline|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568582|NCT00081731|B1|Baseline|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568583|NCT00081731|P2|Participant Flow|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568584|NCT00081731|P1|Participant Flow|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568585|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568586|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568587|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568588|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568589|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568590|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568591|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568592|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568593|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568594|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568595|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568596|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568597|NCT00081731|O2|Outcome|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568598|NCT00081731|O1|Outcome|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568599|NCT00081731|E2|Reported Event|Stenting|"Stent procedure plus optimal anti-hypertensive therapy~GENESISTM Embolic Protection Stent and Angioguard Device (Angioplasty plus stenting): Angioplasty plus stenting of the renal artery GENESISTM Embolic Protection Stent and Angioguard Device"
568600|NCT00081731|E1|Reported Event|Optimal Medical Therapy|"Optimal anti-hypertensive therapy~Atacand/HCT, Caduet: Atacand/HCT and caduet or optimal medical therapy for hypertension"
568601|NCT00081653|B3|Baseline|Total|Total of all reporting groups
568602|NCT00081653|B2|Baseline|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568603|NCT00081653|B1|Baseline|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568604|NCT00081653|P2|Participant Flow|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568605|NCT00081653|P1|Participant Flow|Ibandronate 100 Milligrams (mg)|100 mg ibandronate oral (PO) monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568606|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568607|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandgronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568608|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568609|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568610|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568611|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568612|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568613|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568614|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568615|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568616|NCT00081653|O2|Outcome|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568617|NCT00081653|O1|Outcome|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568618|NCT00081653|E2|Reported Event|Ibandronate 150 mg|150 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 100 mg tablet)
568619|NCT00081653|E1|Reported Event|Ibandronate 100 mg|100 mg ibandronate PO monthly and monthly oral placebo (corresponding to the 150 mg tablet)
568620|NCT00081497|B3|Baseline|Total|Total of all reporting groups
568621|NCT00081497|B2|Baseline|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
568622|NCT00081497|B1|Baseline|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
568623|NCT00081497|P2|Participant Flow|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
568624|NCT00081497|P1|Participant Flow|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
568625|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
568663|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
569136|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
568626|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
568627|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
568628|NCT00081497|O1|Outcome|Fabrazyme 1.0 mg/kg Every 2 Weeks|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months. This is an open-label extension study to AGAL-008-00 (NCT00074984) and all patients received Fabrazyme treatment.
568629|NCT00081497|O4|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR ≤60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
568630|NCT00081497|O3|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR ≤60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry to AGAL02503 (NCT00081497) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
568631|NCT00081497|O2|Outcome|Fabrazyme - AGAL02503 (NCT00081497) eGFR >60|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497) using all Fabrazyme treatment period data from the AGAL00800 (NCT00074984) and AGAL02503 (NCT00081497) studies.
568632|NCT00081497|O1|Outcome|Placebo - AGAL-008-00 (NCT00074984) eGFR >60|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) using only placebo period data from the AGAL-008-00 (NCT00074984) study.
568633|NCT00081497|O2|Outcome|Fabrazyme Period - AGAL02503 (NCT00081497)|Placebo patients who had been transitioned to open-label Fabrazyme prior to or at entry into AGAL02503 (NCT00081497). 1.0 mg/kg of Fabrazyme given to the patients every 2 weeks for 18 months.
568634|NCT00081497|O1|Outcome|Placebo Period - AGAL-008-00 (NCT00074984)|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984).
568635|NCT00081497|E3|Reported Event|Total|
568636|NCT00081497|E2|Reported Event|Placebo/Fabrazyme|Patients who had been randomized to placebo during AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry to AGAL02503 (NCT00081497).
568637|NCT00081497|E1|Reported Event|Fabrazyme/Fabrazyme|Patients who had been randomized to Fabrazyme in AGAL-008-00 (NCT00074984) and were then transitioned to open-label Fabrazyme (1.0 mg/kg every 2 weeks) prior to or at entry into AGAL02503 (NCT00081497).
568638|NCT00081458|B4|Baseline|Total|Total of all reporting groups
568639|NCT00081458|B3|Baseline|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
568640|NCT00081458|B2|Baseline|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
568641|NCT00081458|B1|Baseline|Placebo|Placebo injected subcutaneously daily
568642|NCT00081458|P3|Participant Flow|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
568643|NCT00081458|P2|Participant Flow|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
568644|NCT00081458|P1|Participant Flow|Placebo|Placebo injected subcutaneously daily
568645|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
568646|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
568647|NCT00081458|O1|Outcome|Placebo|Placebo injected subcutaneously daily into the thigh or abdomen
568648|NCT00081458|O3|Outcome|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
568649|NCT00081458|O2|Outcome|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
568650|NCT00081458|O1|Outcome|Placebo|Placebo injectable subcutaneously daily into the thigh or abdomen
568651|NCT00081458|E3|Reported Event|Teduglutide 0.1 mg/kg/d|teduglutide 0.1 mg/kg/d injected subcutaneously
568652|NCT00081458|E2|Reported Event|Teduglutide 0.05 mg/kg/d|teduglutide 0.05 mg/kg/d injected subcutaneously
568653|NCT00081458|E1|Reported Event|Placebo|Placebo injected subcutaneously daily
568654|NCT00081328|B4|Baseline|Total|Total of all reporting groups
568655|NCT00081328|B3|Baseline|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568656|NCT00081328|B2|Baseline|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568657|NCT00081328|B1|Baseline|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568658|NCT00081328|P3|Participant Flow|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid, encapsulated, provided in weekly packets~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568659|NCT00081328|P2|Participant Flow|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid, provided encapsulated in weekly packets"
568660|NCT00081328|P1|Participant Flow|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid, provided encapsulated in weekly packets"
568661|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568662|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568664|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568665|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568666|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568667|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568668|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568669|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568670|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568671|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568672|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568673|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568674|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568675|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568676|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568677|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568678|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568679|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568680|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568681|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568682|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568683|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568684|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568685|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568686|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568687|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568688|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568689|NCT00081328|O2|Outcome|2 Metformin + Rosiglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568690|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568733|NCT00080912|E2|Reported Event|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
569137|NCT00078325|O3|Outcome|Placebo|Matching placebo tablets once daily
568691|NCT00081328|O3|Outcome|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568692|NCT00081328|O2|Outcome|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568693|NCT00081328|O1|Outcome|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568694|NCT00081328|E3|Reported Event|3 Metformin + Lifestyle Program|"Metformin + Lifestyle Program~Metformin: capsule, 1000 mg bid~Lifestyle Program: a lifestyle change (LC) phase of weekly sessions for months 1-6, followed by a bi-weekly lifestyle maintenance (LM) phase through months 7-12, and a continued contact (CC) phase from months 13 through the end of the study. The CC phase sessions are scheduled monthly for the initial 12 months (study months 13-24) and then quarterly or 4 times a year to the end of the study"
568695|NCT00081328|E2|Reported Event|2 Metformin + Rosliglitazone|"Metformin + Rosiglitazone~Metformin: capsule, 1000 mg bid~Rosiglitazone: capsule, 4 mg bid"
568696|NCT00081328|E1|Reported Event|1 Metformin Alone|"Metformin alone~Metformin: capsule, 1000 mg bid"
568697|NCT00081289|B3|Baseline|Total|Total of all reporting groups
568698|NCT00081289|B2|Baseline|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568699|NCT00081289|B1|Baseline|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568700|NCT00081289|P2|Participant Flow|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568701|NCT00081289|P1|Participant Flow|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy (RT), 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568702|NCT00081289|O2|Outcome|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568703|NCT00081289|O1|Outcome|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568704|NCT00081289|E2|Reported Event|Neoadjuvant Chemoradiation With Oxaliplatin|Patients receive neoadjuvant therapy comprising radiotherapy, 1650mg/m2/day oral capecitabine and oxaliplatin. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568705|NCT00081289|E1|Reported Event|Neoadjuvant Chemoradiation With Irinotecan|Patients receive neoadjuvant therapy comprising radiotherapy, 1200mg/m2/day oral capecitabine and irinotecan. Surgery 4-8 weeks after RT. Postoperative chemotherapy (folinic acid, fluorouracil, and oxaliplatin) 4-6 weeks after surgery.
568706|NCT00081159|B3|Baseline|Total|Total of all reporting groups
568707|NCT00081159|B2|Baseline|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
568708|NCT00081159|B1|Baseline|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568709|NCT00081159|P2|Participant Flow|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
568710|NCT00081159|P1|Participant Flow|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin intravenous (IV) on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568711|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
568712|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568713|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
569138|NCT00078325|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568714|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568715|NCT00081159|O2|Outcome|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
568716|NCT00081159|O1|Outcome|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568717|NCT00081159|E2|Reported Event|HAT, Doxorubicin + Zoledronate|Arm II: HAT, doxorubicin, and zoledronate as in arm I. HAT comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses.
568718|NCT00081159|E1|Reported Event|HAT, Doxorubicin, Zoledronate + Strontium Chloride|Arm I: Hormonal ablative therapy (HAT) comprising luteinizing hormone-releasing hormone agonist (e.g., leuprolide or goserelin) continuously during study treatment OR bilateral orchiectomy; doxorubicin IV on days 1, 8, and 15 every 28 days for 2 courses; zoledronate IV over 15 minutes on day 1 every 28 days for 6 courses; and a single dose of strontium chloride Sr 89 IV over 1-2 minutes on day 1.
568719|NCT00080938|B1|Baseline|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568720|NCT00080938|P1|Participant Flow|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568721|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568722|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568723|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568724|NCT00080938|O1|Outcome|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568725|NCT00080938|E1|Reported Event|Temozolamide and Radiation|Patients were to receive whole brain radiation therapy (WBRT), 30 Gy in ten fractions, plus Temozolomide (TMZ) given at a dose of 75 mg/m2/day for 14 days starting on day 1 of radiotherapy. Three weeks after completion of WBRT, TMZ was to be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28 days for up to 6 cycles post WBRT (for a total of 7 cycles of protocol treatment).
568726|NCT00080912|B3|Baseline|Total|Total of all reporting groups
568727|NCT00080912|B2|Baseline|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
568728|NCT00080912|B1|Baseline|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
568729|NCT00080912|P2|Participant Flow|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
568730|NCT00080912|P1|Participant Flow|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
568731|NCT00080912|O2|Outcome|Multiple-fraction|"Patients receive multiple-fraction radiotherapy (to a total of 20 Gy) over 5 days or over 8 days if re-irradiation of the spine and/or whole pelvis is involved AND prior initial radiotherapy was given in multiple fractions.~radiation therapy: Given in a single fraction or multiple fractions"
568732|NCT00080912|O1|Outcome|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
568734|NCT00080912|E1|Reported Event|Single-fraction|"Patients receive single-fraction radiotherapy (8 Gy) on day 1.~radiation therapy: Given in a single fraction or multiple fractions"
568735|NCT00080899|B1|Baseline|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
568736|NCT00080899|P1|Participant Flow|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
568737|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
568738|NCT00080899|O1|Outcome|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
568739|NCT00080899|E1|Reported Event|Arm 1|Patients received Fenretinide (N-(4-hydroxyphenyl) retinamide [4-HPR]) at a dose of 900 mg/m2 twice daily for the maximal practical dose of 1800 mg/m2/day for 1 week, every 3 weeks, for 1 year.
568740|NCT00080535|B1|Baseline|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
568741|NCT00080535|P1|Participant Flow|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
568742|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
568743|NCT00080535|O1|Outcome|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
568744|NCT00080535|E1|Reported Event|LMB-2 for Cutaneous Tcell Lymphoma|30 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with cutaneous T-cell lymphoma, a group of lymphoproliferative disorders characterized by malignant CD4+ T-lymphocytes which localize tot he skin on initial presentation.
568745|NCT00080483|B3|Baseline|Total|Total of all reporting groups
568746|NCT00080483|B2|Baseline|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
568747|NCT00080483|B1|Baseline|1Testosterone Only|Testosterone transdermally 5 g a day
568748|NCT00080483|P2|Participant Flow|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
568749|NCT00080483|P1|Participant Flow|1Testosterone Only|Testosterone transdermally 5 g a day
568750|NCT00080483|O2|Outcome|2 The Effects of Testosterone Alone on Structural and Mechanic|"AndroGel transdermally 5 g a day for two years~testosterone: AndroGel transdermally 5 g a day for two years"
568751|NCT00080483|O1|Outcome|1 The Effects of Testosterone Combined With G|"AndroGel transdermally 5 g a day and somatropin subcutaneously 2 µg/kg body weight a day~AndroGel plus somatropin: AndoGel 5 grams transdermally a day for two years Somatropin 2 µg/kg body weight/day for two years"
568752|NCT00080483|E2|Reported Event|2Testosterone Plus Growth Hormone|AndroGel transdermally 5 g a day somatropin subcutaneously 2 µg/kg body weight a day
568753|NCT00080483|E1|Reported Event|1Testosterone Only|Testosterone transdermally 5 g a day
568754|NCT00080470|B3|Baseline|Total|Total of all reporting groups
568755|NCT00080470|B2|Baseline|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
568756|NCT00080470|B1|Baseline|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
568757|NCT00080470|P2|Participant Flow|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
568758|NCT00080470|P1|Participant Flow|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
568759|NCT00080470|O2|Outcome|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
568760|NCT00080470|O1|Outcome|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
568761|NCT00080470|O2|Outcome|Control|No Stimulation from post-implant until 45 days post-implant. Stimulation On from 45 days post-implant and on.
568762|NCT00080470|O1|Outcome|Treatment|"Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit.~Stimulation On from 45 days post 12 month visit and on."
568763|NCT00080470|E2|Reported Event|Treatment|Stimulation On from Initial Activation up to the 12 month post-activation. Stimulation Off from 12 months post-activation until 45 days after the 12 month visit. Stimulation On from 45 days post 12 month visit and on.
568764|NCT00080470|E1|Reported Event|Control|No stimulation until 45 days post-implant. Stimulation On from 45 days post-implant and on.
568765|NCT00080301|B3|Baseline|Total|Total of all reporting groups
568766|NCT00080301|B2|Baseline|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568767|NCT00080301|B1|Baseline|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568768|NCT00080301|P2|Participant Flow|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568769|NCT00080301|P1|Participant Flow|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568770|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
569139|NCT00078325|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
568771|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568772|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568773|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone in combination with capecitabine (combination group): Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each cycle only, plus oral capecitabine 1000 mg/m2 twice a day (BID) (2000 mg/m2 daily dose) x 14 days, followed by 1 week of rest.
568774|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568775|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568776|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568777|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568778|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568779|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568780|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568781|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568782|NCT00080301|O2|Outcome|Capecitabine|Capecitabine 1250 mg/m2 BID x 14 days
568783|NCT00080301|O1|Outcome|Ixabepilone + Capecitabine|Ixabepilone 40 mg/m2 administered as a 3-hour intravenous (IV) infusion on Day 1 of each 21-day cycle, plus oral capecitabine 1000 mg/m2 twice a day (BID) x 14 days
568784|NCT00080301|E2|Reported Event|Ixabepilone + Capecitabine|
568785|NCT00080301|E1|Reported Event|Capecitabine|
568786|NCT00080288|B3|Baseline|Total|Total of all reporting groups
568787|NCT00080288|B2|Baseline|Placebo|Matching placebo tablets once daily
568788|NCT00080288|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
568789|NCT00080288|P2|Participant Flow|Placebo|Matching placebo tablets once daily
568790|NCT00080288|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
568791|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
568792|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
568793|NCT00080288|O2|Outcome|Placebo|Matching placebo tablets once daily
568794|NCT00080288|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
568795|NCT00080288|E2|Reported Event|Placebo|Matching placebo tablets once daily
568796|NCT00080288|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg taken 30 minutes to 1 hour before the start of the night shift, but no later than 2300, only on nights worked
568797|NCT00080223|B1|Baseline|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568798|NCT00080223|P1|Participant Flow|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 milligram per day (mg/d). At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose greater than (>) 4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568799|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568800|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568801|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568802|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
569016|NCT00078715|P1|Participant Flow|Placebo Then Yohimbine|Participants are randomized to blindly receive placebo for 8 days then yohimbine for the same.
568803|NCT00080223|O1|Outcome|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568804|NCT00080223|E1|Reported Event|Pirfenidone|Pirfenidone was administered orally, in divided doses, three times daily at a maximum dose of up to 3600 mg/d. At the start of treatment in this study, doses for participants with no previous pirfenidone exposure and for those who took their last dose >4 weeks before enrollment were titrated to their maintenance dose based on body weight and tolerability. Dose titration was also required after a dosing interruption of >28 days. Pirfenidone was administered for a maximum duration of 604 weeks in this study.
568805|NCT00080119|B5|Baseline|Total|Total of all reporting groups
568806|NCT00080119|B4|Baseline|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568807|NCT00080119|B3|Baseline|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568808|NCT00080119|B2|Baseline|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568809|NCT00080119|B1|Baseline|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568810|NCT00080119|P4|Participant Flow|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568811|NCT00080119|P3|Participant Flow|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568812|NCT00080119|P2|Participant Flow|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568813|NCT00080119|P1|Participant Flow|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568814|NCT00080119|O4|Outcome|HIVpos/PL|
568815|NCT00080119|O3|Outcome|HIVpos/INH|
568816|NCT00080119|O2|Outcome|HIVneg/PL|
568817|NCT00080119|O1|Outcome|HIVneg/INH|
568818|NCT00080119|O4|Outcome|HIVpos/PL|
568819|NCT00080119|O3|Outcome|HIVpos/INH|
568820|NCT00080119|O2|Outcome|HIVneg/PL|
568821|NCT00080119|O1|Outcome|HIVneg/INH|
568822|NCT00080119|O4|Outcome|HIVpos/PL|
568823|NCT00080119|O3|Outcome|HIVpos/INH|
568824|NCT00080119|O2|Outcome|HIVneg/PL|
568825|NCT00080119|O1|Outcome|HIVneg/INH|
568826|NCT00080119|O4|Outcome|HIVpos/PL|
568827|NCT00080119|O3|Outcome|HIVpos/INH|
568828|NCT00080119|O2|Outcome|HIVneg/PL|
568829|NCT00080119|O1|Outcome|HIVneg/INH|
568830|NCT00080119|O2|Outcome|HIVneg/PL|
568831|NCT00080119|O1|Outcome|HIVneg/INH|
568832|NCT00080119|O2|Outcome|HIVpos/PL|
568833|NCT00080119|O1|Outcome|HIVpos/INH|
568834|NCT00080119|O2|Outcome|HIVpos/PL|
568835|NCT00080119|O1|Outcome|HIVpos/INH|
568836|NCT00080119|O2|Outcome|HIVneg/PL|
568837|NCT00080119|O1|Outcome|HIVneg/INH|
568838|NCT00080119|O2|Outcome|HIVpos/PL|
568839|NCT00080119|O1|Outcome|HIVpos/INH|
568840|NCT00080119|E4|Reported Event|HIVpos/PL|HIV-infected (HIVpos) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568841|NCT00080119|E3|Reported Event|HIVpos/INH|HIV-infected (HIVpos) children receiving Isoniazid (INH) 10-20 mg/kg orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until one year of age. TMP/SMX may have been continued after one year of age according to WHO guidelines.
568842|NCT00080119|E2|Reported Event|HIVneg/PL|Perinatally-exposed, HIV-uninfected (HIVneg) children receiving Isoniazid placebo (PL) orally once a day for 96 weeks + TMP/SMX 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568843|NCT00080119|E1|Reported Event|HIVneg/INH|Perinatally exposed, HIV-uninfected (HIVneg) children receiving Isoniazid (INH)10-20 mg/kg orally once a day for 96 weeks + Trimethoprim/Sulfamethoxazole (TMP/SMX) 5 mg/kg of TMP component orally once a day until HIV status is confirmed and child is no longer at risk of acquiring HIV through breastfeeding
568844|NCT00079937|B3|Baseline|Total|Total of all reporting groups
568845|NCT00079937|B2|Baseline|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
569017|NCT00078715|O2|Outcome|Yohimbine|Participants are randomized to blindly receive yohimbine for 8 days.
569018|NCT00078715|O1|Outcome|Placebo|Participants are randomized to blindly receive placebo for 8 days.
568846|NCT00079937|B1|Baseline|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568847|NCT00079937|P2|Participant Flow|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568848|NCT00079937|P1|Participant Flow|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568849|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568850|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568851|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568852|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568853|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568854|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568855|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568856|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568857|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568858|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568859|NCT00079937|O2|Outcome|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
569019|NCT00078715|E2|Reported Event|Yohimbine|
569020|NCT00078715|E1|Reported Event|Placebo|
568860|NCT00079937|O1|Outcome|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568861|NCT00079937|E2|Reported Event|Placebo|Placebo was administered by subcutaneous injection every 2 or 4 weeks depending on the dosing schedule in the protocol for a total of 52 weeks. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568862|NCT00079937|E1|Reported Event|Omalizumab|Participants received omalizumab administered by subcutaneous injection every 2 or 4 weeks for a duration of 52 weeks. The omalizumab dose was based on the patient's body weight and total serum IgE level at Screening. The first 24 weeks of the treatment period was a fixed steroid phase where the steroid dose was maintained constant; in the following 28 weeks the steroid dose was adjustable, depending on the patient's condition. Following the 52-week treatment period, patients were followed up for an additional 16 weeks.
568863|NCT00079781|B4|Baseline|Total|Total of all reporting groups
568864|NCT00079781|B3|Baseline|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
568865|NCT00079781|B2|Baseline|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
568866|NCT00079781|B1|Baseline|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
568867|NCT00079781|P3|Participant Flow|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period. Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
568868|NCT00079781|P2|Participant Flow|Treatment Group|Group of subjects who underwent RNS® System implantation who were randomized to receive RNS® System responsive stimulation (i.e. responsive stimulation enabled or turned ON) during the blinded Evaluation Period. Stimulation was enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
568869|NCT00079781|P1|Participant Flow|Open Label Group|Group of subjects who underwent RNS® System implantation who were not randomized or blinded to therapy status during the Evaluation Period. Stimulation may have been enabled during the first month post-implant and may have continued throughout the subject's participation in the study.
568870|NCT00079781|O1|Outcome|Treatment Population|Open Label Group and Treatment Group combined.
568871|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
568872|NCT00079781|O1|Outcome|All Participants|Open Label Group, Treatment Group, and Sham Group combined.
568873|NCT00079781|E2|Reported Event|Sham Group|Group of subjects who underwent RNS® System implantation who were randomized to receive sham-stimulation (i.e. responsive stimulation disabled or turned OFF) during the blinded Evaluation Period). Stimulation may have been enabled after transition into the Follow-Up Period (5th month post-implant) and may have continued for the remainder of the subject's participation in the study.
568874|NCT00079781|E1|Reported Event|Treatment Population|Open Label Group and Treatment Group combined.
568875|NCT00079677|B3|Baseline|Total|Total of all reporting groups
568876|NCT00079677|B2|Baseline|Placebo|Matching placebo tablets once daily
568877|NCT00079677|B1|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568878|NCT00079677|P2|Participant Flow|Placebo|Matching placebo tablets once daily
568879|NCT00079677|P1|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568880|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
568881|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568882|NCT00079677|O2|Outcome|Placebo|Matching placebo tablets once daily
568883|NCT00079677|O1|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568884|NCT00079677|E2|Reported Event|Placebo|Matching placebo tablets once daily
568885|NCT00079677|E1|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568886|NCT00079417|B1|Baseline|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
568900|NCT00079339|B3|Baseline|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568887|NCT00079417|P1|Participant Flow|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
568888|NCT00079417|O1|Outcome|Vincristine Sulfate and Carboplatin and Surgery|"Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.~cryosurgery: Application of extreme cold to destroy abnormal or diseased tissue.~infrared laser therapy: Laser therapy or “photobiomodulation” is the use of specific wavelength of light (red and near-infrared) to create therapeutic effects~iodine I 125: Undergo radioactive therapy~ruthenium Ru 106: Undergo radioactive therapy~carboplatin: Given IV~vincristine sulfate: Given IV"
568889|NCT00079417|E1|Reported Event|Vincristine Sulfate and Carboplatin and Surgery|Patients receive chemoreduction comprising carboplatin IV (Pts < 36 months: 18.6 mg/kg Pts ≥ 36 months: 560 mg/m2) over 60 minutes followed by vincristine sulfate IV (Pts < 36 months: 0.05 mg/kg Pts ≥36 months: 1.5 mg/m2) over 1-2 minutes on day 1. Treatment repeats every 28 days for 6 courses in the absence of disease progression or unacceptable toxicity. After the first course of chemoreduction, patients undergo standardized local ophthalmic therapy comprising local infrared laser therapy, cryosurgery, and/or radiation therapy (radioactive) plaque comprising iodine I 125 or ruthenium Ru 106.
568890|NCT00079391|B1|Baseline|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568891|NCT00079391|P1|Participant Flow|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568892|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568893|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568894|NCT00079391|O1|Outcome|"Bone Marrow Transplantation Using Nexell Isolex 300i"|"Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. Cluster of differentiation 34 (CD34) selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant."
568895|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568896|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568897|NCT00079391|O1|Outcome|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568898|NCT00079391|E1|Reported Event|Bone Marrow Transplantation Using Nexell Isolex 300i|Bone marrow stem cell transplant program to improve the outcome of allogeneic Bone Marrow Transplant for hematologic malignancies. Immunosuppression including cyclosporine will be given six days prior to transplant up to 21 days post transplant. CD34 selection and T cell depletion using Isolex 300i immuno-magnetic cell selection and immunosuppression during peri- transplant.
568899|NCT00079339|B4|Baseline|Total|Total of all reporting groups
568933|NCT00079274|B3|Baseline|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
569140|NCT00078325|E3|Reported Event|Placebo|Matching placebo tablets once daily
568901|NCT00079339|B2|Baseline|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
568902|NCT00079339|B1|Baseline|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568903|NCT00079339|P3|Participant Flow|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568904|NCT00079339|P2|Participant Flow|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
568905|NCT00079339|P1|Participant Flow|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568906|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
568907|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had a baseline positron emission tomography (PET) scan.
568908|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI scan.
568909|NCT00079339|O1|Outcome|Tipifarnib - All Dose Levels|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI diffusion scan.
568910|NCT00079339|O1|Outcome|Tipifarnib - Any Dose Level|Participants treated at any dose level who had the baseline and on treatment (two weeks post completion of radiation) MRI perfusion scan.
568911|NCT00079339|O1|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
568912|NCT00079339|O3|Outcome|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
568913|NCT00079339|O2|Outcome|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
568979|NCT00078949|P3|Participant Flow|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
568914|NCT00079339|O1|Outcome|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study."
568915|NCT00079339|E3|Reported Event|Tipifarnib 150-mg/m2|"Tipifarnib 150 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568916|NCT00079339|E2|Reported Event|Tipifarnib 125-mg/m2|"Tipifarnib 125 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~The 125 mg/m2 dose level was determined to be the MTD and therefore the recommended phase II dose. Of the 40 participants treated at this dose level, six were enrolled on the phase I part of the study and 34 were enrolled to the phase II."
568917|NCT00079339|E1|Reported Event|Tipifarnib 100-mg/m2|"Tipifarnib 100 mg/m2 twice a day for 6 weeks concurrent with radiation therapy followed by a two week rest period. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period – first 8 weeks). Tipifarnib was continued at 200 mg/m2 twice a day, starting at course 3, for 21 days followed by 7 days of rest. Treatment repeats every 4 weeks for up to 24 additional courses.~Local radiation (RT) was initiated 1-2 days following the first dose of tipifarnib and was administered once daily, five days per week , at 180 cGy/day fractions for six weeks to a total dose of 5580 cGy.~All participants treated at this dose level were enrolled to the phase I part of the study only."
568918|NCT00079326|B3|Baseline|Total|Total of all reporting groups
568919|NCT00079326|B2|Baseline|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568920|NCT00079326|B1|Baseline|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568921|NCT00079326|P2|Participant Flow|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568922|NCT00079326|P1|Participant Flow|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568923|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568924|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568925|NCT00079326|O2|Outcome|Cohort 2: 1-2 Prior Trastuzumab Treatment Regimens|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568926|NCT00079326|O1|Outcome|Cohort 1: No Prior Chemo or Trastuzumab Treatment|Patients receive trastuzumab IV over 30-90 minutes and ixabepilone 40 mg/m2 IV over 3 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
568927|NCT00079326|E1|Reported Event|All Study Participants|All Adverse Events and Serious Adverse event data was pooled because all participants received the same treatment.
568928|NCT00079274|B8|Baseline|Total|Total of all reporting groups
568929|NCT00079274|B7|Baseline|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
568930|NCT00079274|B6|Baseline|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568931|NCT00079274|B5|Baseline|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568932|NCT00079274|B4|Baseline|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568934|NCT00079274|B2|Baseline|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568935|NCT00079274|B1|Baseline|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568936|NCT00079274|P7|Participant Flow|Arm G (Locally Directed Therapy)|"Patients determined to have mutated Kirsten rat sarcoma (KRAS) (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) were assigned to an event monitoring arm in which adjuvant therapy was determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification was the responsibility of the treating oncologists."
568937|NCT00079274|P6|Participant Flow|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568938|NCT00079274|P5|Participant Flow|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given I~cetuximab: Given IV"
568939|NCT00079274|P4|Participant Flow|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients received cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568940|NCT00079274|P3|Participant Flow|Arm C (Combination Chemotherapy)|"Patients received the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568941|NCT00079274|P2|Participant Flow|Arm B (Combination Chemotherapy)|"Patients received irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568942|NCT00079274|P1|Participant Flow|Arm A (Combination Chemotherapy)|"Patients received oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeated every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568943|NCT00079274|O2|Outcome|Mutant KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm A patients.
568944|NCT00079274|O1|Outcome|Mutant KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are mutant KRAS and concurrently randomized with Arm D patients.
568945|NCT00079274|O2|Outcome|Wild-type KRAS Arm D|Patients from Arm D (and a few patients from Arm F that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm A patients.
568946|NCT00079274|O1|Outcome|Wild-type KRAS Arm A|Patients from Arm A (and a few patients from Arm C that did not receive irinotecan) that are wild-type KRAS and concurrently randomized with Arm D patients.
568947|NCT00079274|E7|Reported Event|Arm G (Locally Directed Therapy)|"Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists.~Locally Directed Therapy: Patients determined to have mutated KRAS (or KRAS not evaluable) will be assigned to an event monitoring arm in which adjuvant therapy will be determined and assigned by the treating oncologist. The determination of the type of therapy, duration of treatment, and dose modification will be the responsibility of the treating oncologists."
568948|NCT00079274|E6|Reported Event|Arm F (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and chemotherapy as in arm C.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568949|NCT00079274|E5|Reported Event|Arm E (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab as in arm D and irinotecan, leucovorin calcium, and fluorouracil as in arm B. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568950|NCT00079274|E4|Reported Event|Arm D (Combination Chemotherapy, Monoclonal Antibody)|"Patients receive cetuximab IV over 1 hour on days 1 and 8 and oxaliplatin, leucovorin calcium, and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV~cetuximab: Given IV"
568951|NCT00079274|E3|Reported Event|Arm C (Combination Chemotherapy)|"Patients receive the same treatment as in arm A for 6 courses followed by the same treatment as in arm B for 6 courses (total of 12 courses). Treatment continues in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568952|NCT00079274|E2|Reported Event|Arm B (Combination Chemotherapy)|"Patients receive irinotecan IV over 2 hours on day 1 and leucovorin calcium and fluorouracil as in arm A. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~irinotecan hydrochloride: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
569141|NCT00078325|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
568953|NCT00079274|E1|Reported Event|Arm A (Combination Chemotherapy)|"Patients receive oxaliplatin IV over 2 hours, leucovorin calcium IV over 2 hours, and fluorouracil IV continuously over 46-48 hours on days 1. Treatment repeats every 14 days for up to 12 courses in the absence of unacceptable toxicity or recurrent disease.~oxaliplatin: Given IV~leucovorin calcium: Given IV~fluorouracil: Given IV"
568954|NCT00079040|B1|Baseline|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568955|NCT00079040|P1|Participant Flow|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568956|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568957|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568958|NCT00079040|O1|Outcome|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568959|NCT00079040|E1|Reported Event|Cisplatin, Etoposide, Bevacizumab|Cisplatin 60 mg/m2 IV, Etoposide 120 mg/m2 IV, and Bevacizumab 15 mg/kg IV on Day 1, Etoposide 120 mg/m2 IV on days 2 and 3 of a 21-day cycle for 4 cycles. Bevacizumab continued for 1 year or until progression.
568960|NCT00079001|B3|Baseline|Total|Total of all reporting groups
568961|NCT00079001|B2|Baseline|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568962|NCT00079001|B1|Baseline|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568963|NCT00079001|P2|Participant Flow|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568964|NCT00079001|P1|Participant Flow|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568965|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568966|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568967|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568968|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568969|NCT00079001|O2|Outcome|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568970|NCT00079001|O1|Outcome|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568971|NCT00079001|E2|Reported Event|Placebo + Androgen Deprivation Therapy|Placebo bu IV over 15 minutes for 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progress on blinded treatment before having a skeletal event may continue on open label Zoledronic acid.
568972|NCT00079001|E1|Reported Event|Zoledronic Acid + Androgen Deprivation Therapy|4mg by IV over 15 minutes every 4 weeks in the absence of disease progression or the first skeletal-related event. Participants who progression on blinded treatment before having a skeletal event may continue on open label Zoledronic acid (4 mg by IV over 15 minutes every 3 weeks).
568973|NCT00078949|B5|Baseline|Total|Total of all reporting groups
568974|NCT00078949|B4|Baseline|Observation|Patients undergo observation only.
568975|NCT00078949|B3|Baseline|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
568976|NCT00078949|B2|Baseline|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
568977|NCT00078949|B1|Baseline|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
568978|NCT00078949|P4|Participant Flow|Observation|Patients undergo observation only.
568980|NCT00078949|P2|Participant Flow|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
568981|NCT00078949|P1|Participant Flow|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
568982|NCT00078949|O2|Outcome|Observation|Patients undergo observation only.
568983|NCT00078949|O1|Outcome|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
568984|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
568985|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
568986|NCT00078949|O2|Outcome|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
568987|NCT00078949|O1|Outcome|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
568988|NCT00078949|E4|Reported Event|Observation|Patients undergo observation only.
568989|NCT00078949|E3|Reported Event|Maintenance|"Beginning on day 28 posttransplantation, patients receive rituximab IV once every 2 months for 6 doses (a total of 12 months) in the absence of disease progression or unacceptable toxicity.~rituximab: Given IV"
568990|NCT00078949|E2|Reported Event|Salvage DHAP|"Patients receive cisplatin IV over 24 hours on day 1, dexamethasone as in arm I, and cytarabine IV over 3 hours every 12 hours for a total of 2 doses on day 2.~cisplatin: Given IV~cytarabine: Given IV~dexamethasone: Given IV"
568991|NCT00078949|E1|Reported Event|Salvage GDP|"Patients receive cisplatin IV over 60 minutes on day 1, dexamethasone IV or orally on days 1-4, and gemcitabine IV over 30 minutes on days 1 and 8.~cisplatin: Given IV~dexamethasone: Given IV~gemcitabine hydrochloride: Given IV"
568992|NCT00078754|B4|Baseline|Total|Total of all reporting groups
568993|NCT00078754|B3|Baseline|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
568994|NCT00078754|B2|Baseline|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
568995|NCT00078754|B1|Baseline|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
568996|NCT00078754|P3|Participant Flow|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
568997|NCT00078754|P2|Participant Flow|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
568998|NCT00078754|P1|Participant Flow|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
568999|NCT00078754|O3|Outcome|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
569000|NCT00078754|O2|Outcome|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
569001|NCT00078754|O1|Outcome|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
569002|NCT00078754|E3|Reported Event|Group C - Placebo|"Participants will to receive treatment with placebo for 12 weeks~Placebo: Placebo capsules by mouth, up to 8 capsules daily"
569003|NCT00078754|E2|Reported Event|Group B - Divalproex Drug|"Participants will to receive treatment with divalproex for 12 weeks~Divalproex: Divalproex ER capsules by mouth, up to 3000 mg daily"
569004|NCT00078754|E1|Reported Event|Group A - Fluoxetine Drug|"Participants will to receive treatment with fluoxetine for 12 weeks~Fluoxetine: Fluoxetine capsules by mouth, up to 60 mg daily"
569005|NCT00078728|B3|Baseline|Total|Total of all reporting groups
569006|NCT00078728|B2|Baseline|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
569007|NCT00078728|B1|Baseline|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
569008|NCT00078728|P2|Participant Flow|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
569009|NCT00078728|P1|Participant Flow|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
569010|NCT00078728|O2|Outcome|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
569011|NCT00078728|O1|Outcome|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
569012|NCT00078728|E2|Reported Event|2 Evaluation Only|Evaluation only : Participants will undergo evaluations without active treatment for 8 weeks.
569013|NCT00078728|E1|Reported Event|1 Family-based Prevention Program|Family-Based Anxiety Prevention Program : Participants in the prevention program will have weekly sessions with a therapist and will learn skills to help reduce anxiety for 8 weeks.
569014|NCT00078715|B1|Baseline|Overall Study|
569015|NCT00078715|P2|Participant Flow|Yohimbine Then Placebo|Participants are randomized to blindly receive yohimbine for 8 days then placebo for the same.
569021|NCT00078559|B1|Baseline|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569022|NCT00078559|P1|Participant Flow|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569023|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569024|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569025|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569026|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569027|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569028|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569029|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569030|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569031|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569032|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569080|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569033|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569034|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569035|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569036|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569037|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569038|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569039|NCT00078559|O2|Outcome|Alemtuzumab (Not Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12)
569040|NCT00078559|O1|Outcome|Alemtuzumab (Withdrawn From Sirolimus)|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569041|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569042|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569043|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569044|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from Day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569062|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569045|NCT00078559|O1|Outcome|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569046|NCT00078559|E1|Reported Event|Alemtuzumab|Recipients of first kidney transplants (0-3 HLA antigen mismatch) received induction therapy with alemtuzumab (1 dose [30 mg]each day, Days 0 [transplant day], 1 and 2, administered intravenously) , tacrolimus (the dose was initially 2 mg twice daily by mouth, and adjusted to maintain target blood levels of 4 to 8 ng/mL from day 1 to Day 60) and sirolimus (the initial dose was 2 mg/day by mouth started <= 48 hours post-transplant, subsequently adjusted to achieve trough levels of 8 to 12 ng/mL through Month 12), followed by sirolimus withdrawal as tolerated
569047|NCT00078403|B4|Baseline|Total|Total of all reporting groups
569048|NCT00078403|B3|Baseline|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569049|NCT00078403|B2|Baseline|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569050|NCT00078403|B1|Baseline|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569051|NCT00078403|P3|Participant Flow|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569052|NCT00078403|P2|Participant Flow|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569053|NCT00078403|P1|Participant Flow|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569054|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569055|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569056|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569057|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569058|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569059|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569060|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation..
569061|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569063|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569064|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569065|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569066|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569067|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569068|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569069|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569070|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569071|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569072|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569073|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569074|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569075|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569076|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569077|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569078|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569079|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569128|NCT00078325|B3|Baseline|Placebo|Matching placebo tablets once daily
569081|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569082|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569083|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569084|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569085|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569086|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569087|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569088|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569089|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569090|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569091|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569092|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569093|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569094|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569095|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569096|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569129|NCT00078325|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569130|NCT00078325|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569131|NCT00078325|P3|Participant Flow|Placebo|Matching placebo tablets once daily
569132|NCT00078325|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569097|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569098|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569099|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569100|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569101|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569102|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569103|NCT00078403|O3|Outcome|C: OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to have undetectable HCV RNA (HCV RNA <600 IU/mL) or at least a 2 log10 decrease in HCV RNA from baseline. Participants entered Step 3 and were assigned to continue the run-in treatment (PEG-IFN 180 mcg weekly & RBV1-1.2 g/day based on weight) for a total of 72 weeks. At week 36, participants who had detectable HCV RNA (HCV RNA >=60 IU/mL using a qualitative assay) could enter Step 2 and be randomized to OL PEG-IFN or Observation.
569104|NCT00078403|O2|Outcome|B: OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to 72 weeks of observation (no treatment).
569105|NCT00078403|O1|Outcome|A: Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period - Step 1) participants were found to have detectable HCV RNA (HCV RNA >=600 IU/mL) and had less than a 2 log10 decrease in HCV RNA from baseline. For Step 2, participants were randomized to receive the pegylated interferon (PEG-IFN) 180 mcg weekly for 72 weeks.
569106|NCT00078403|E3|Reported Event|OL (PEG-IFN, RBV) Then OL (PEG-IFN, RBV)|At week 12 (end of initial run-in period, Step 1) participants were found to be HCV RNA negative (HCV RNA < 60 IU/mL) or had more than a 2 log decrease in HCV RNA from Baseline. Participants were assigned to remain in the Open Label (OL) part of the study continuing the run-in treatment (PEG-IFN 180 mcg weekly & ribavirin [RBV] 1-1.2 g/day based on weight). At the beginning of week 36, participants were retested and, if found to be HCV RNA positive (HCV RNA > 60 IU/mL), participants could be randomized to OL PEG-IFN or Observation.
569107|NCT00078403|E2|Reported Event|OL (PEG-IFN, RBV) Then OL Randomized (Observation)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to be followed on the Observation (no treatment) Arm.
569108|NCT00078403|E1|Reported Event|Open Label (OL) (PEG-IFN, RBV); OL Randomized (PEG-IFN)|At week 12 (end of the initial run-in period – Step 1) participants were found to be HCV RNA positive (HCV RNA > 60 IU/mL) and had less than a 2 log decrease in HCV RNA from Baseline. For Step 2, participants were assigned to the Randomized Open Label (OL) part of the study to receive the pegylated interferon (PEG-IFN) 180 mcg weekly Arm.
569109|NCT00078377|B4|Baseline|Total|Total of all reporting groups
569110|NCT00078377|B3|Baseline|Placebo|Matching placebo tablets once daily in the morning
569111|NCT00078377|B2|Baseline|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569112|NCT00078377|B1|Baseline|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569113|NCT00078377|P3|Participant Flow|Placebo|Matching placebo tablets once daily in the morning
569114|NCT00078377|P2|Participant Flow|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569115|NCT00078377|P1|Participant Flow|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569116|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
569117|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
569118|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569119|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569120|NCT00078377|O4|Outcome|Armodafinil Combined Group (250 mg/Day and 150 mg/Day)|
569121|NCT00078377|O3|Outcome|Placebo|Matching placebo tablets once daily in the morning
569122|NCT00078377|O2|Outcome|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569123|NCT00078377|O1|Outcome|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569124|NCT00078377|E3|Reported Event|Placebo|Matching placebo tablets once daily in the morning
569125|NCT00078377|E2|Reported Event|Armodafinil 150 mg/Day|Armodafinil 150 mg once daily in the morning
569126|NCT00078377|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569127|NCT00078325|B4|Baseline|Total|Total of all reporting groups
569142|NCT00078325|E1|Reported Event|Armodafinil 250 mg/Day|Armodafinil 250 mg once daily in the morning
569143|NCT00078312|B1|Baseline|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
569144|NCT00078312|P1|Participant Flow|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
569145|NCT00078312|O1|Outcome|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
569146|NCT00078312|E1|Reported Event|Armodafinil 100 to 250 mg/Day|Participants with narcolepsy or Obstructive Sleep Apnea/Hypopnea Syndrome (OSAHS): armodafinil once daily in the morning. Participants with chronic Shift Work Sleep Disorder (SWSD): armodafinil 100-250 mg once daily only on nights worked
569147|NCT00078286|B3|Baseline|Total|Total of all reporting groups
569148|NCT00078286|B2|Baseline|Placebo|Participants will take placebo for 12 weeks
569149|NCT00078286|B1|Baseline|Sertraline|Participants will take sertraline for 12 weeks
569150|NCT00078286|P2|Participant Flow|Placebo|Participants will take placebo for 12 weeks
569151|NCT00078286|P1|Participant Flow|Sertraline|Participants will take sertraline for 12 weeks
569152|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
569153|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
569154|NCT00078286|O2|Outcome|Placebo|Participants will take placebo for 12 weeks
569155|NCT00078286|O1|Outcome|Sertraline|Participants will take sertraline for 12 weeks
569156|NCT00078286|E2|Reported Event|Placebo|Serious adverse events in Placebo Arm
569157|NCT00078286|E1|Reported Event|Sertraline|Serious adverse events in Sertraline Arm
569158|NCT00077974|B1|Baseline|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569159|NCT00077974|P1|Participant Flow|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569160|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569161|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569162|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569163|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569164|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569165|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569166|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569167|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569168|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569169|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569170|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569171|NCT00077974|O1|Outcome|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569172|NCT00077974|E1|Reported Event|Sunitinib Malate|50 milligrams per day on Schedule 4/2 (4 weeks daily treatment followed by 2 weeks off treatment in repeated 6-week cycles)
569173|NCT00077922|B1|Baseline|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
569174|NCT00077922|P1|Participant Flow|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
569175|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
569176|NCT00077922|O1|Outcome|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
569177|NCT00077922|E1|Reported Event|LMB-2 in Chronic Lymphocytic Leukemia|40 micrograms/kg every other day (QOD) x 3 every 4 weeks in patients with chronic lymphocytic leukemia, the most prevalent form of adult leukemia.
569178|NCT00077857|B3|Baseline|Total|Total of all reporting groups
569179|NCT00077857|B2|Baseline|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569180|NCT00077857|B1|Baseline|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569181|NCT00077857|P2|Participant Flow|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569182|NCT00077857|P1|Participant Flow|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569183|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569184|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569185|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569186|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569187|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569188|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569189|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569190|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569191|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569192|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569193|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569194|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569195|NCT00077857|O2|Outcome|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569196|NCT00077857|O1|Outcome|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569197|NCT00077857|E2|Reported Event|825 mg/m^2 Capecitabine + Docetaxel|825 mg/m^2 capecitabine orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569198|NCT00077857|E1|Reported Event|1250 mg/m^2 Capecitabine + Docetaxel|1250 mg/m^2 capecitabine (Xeloda®) orally twice a day on days 1 to 14 of each 3 week cycle, in combination with docetaxel (Taxotere®) 75 mg/m^2 intravenous on day 1 of each 3 week cycle.
569199|NCT00077766|B3|Baseline|Total|Total of all reporting groups
569200|NCT00077766|B2|Baseline|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569201|NCT00077766|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569202|NCT00077766|P2|Participant Flow|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569203|NCT00077766|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) intravenously (IV), every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 microgram [µg]) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569204|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569205|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569206|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569207|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569208|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569209|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569210|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569211|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569212|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569213|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569214|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569215|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569216|NCT00077766|O2|Outcome|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569217|NCT00077766|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Weeks 1 through 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569218|NCT00077766|E2|Reported Event|Darbepoetin (1x/1-2 Weeks)|Eligible participants were administered with darbepoetin alfa IV, every week or every 2 weeks during Week 1 through Week 52.
569219|NCT00077766|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants were administered with RO0503821 IV, every 2 weeks during Week 1 through Week 52. The starting dose of RO0503821 (60, 100, or 180 µg) was based on the dose of darbepoetin alfa at the time of randomization (< 40, 40 to 80, or > 80 µg per week, respectively).
569220|NCT00077675|B3|Baseline|Total|Total of all reporting groups
569221|NCT00077675|B2|Baseline|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
569222|NCT00077675|B1|Baseline|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
569223|NCT00077675|P2|Participant Flow|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
569224|NCT00077675|P1|Participant Flow|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
569225|NCT00077675|O2|Outcome|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
569226|NCT00077675|O1|Outcome|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
569227|NCT00077675|E2|Reported Event|Standard of Care for cSSSI|Standard therapy [nafcillin or oxacillin 2 gram, or cloxacillin (in S. Africa) 0.5 to 1.0 gram, every 6 hours, or vancomycin 1 gram every 12 hours, intravenously]
569228|NCT00077675|E1|Reported Event|Telavancin|Telavancin 10 mg/kg every 24 hours intravenously
569229|NCT00077649|B5|Baseline|Total|Total of all reporting groups
569230|NCT00077649|B4|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569231|NCT00077649|B3|Baseline|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks.
569232|NCT00077649|B2|Baseline|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569233|NCT00077649|B1|Baseline|PEG-IFN Alfa-2a 180 mcg+ Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks.
569234|NCT00077649|P4|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569235|NCT00077649|P3|Participant Flow|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569236|NCT00077649|P2|Participant Flow|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569237|NCT00077649|P1|Participant Flow|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 micrograms (mcg) of PEG-IFN [peginterferon] alfa-2a in 1 milliliter (mL) solution administered subcutaneously (SC), once weekly + 1200 milligrams (mg) of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
569238|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569239|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569240|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569241|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569242|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569243|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569244|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569245|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569246|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg+ Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569247|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569248|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569249|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569250|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569251|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569252|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569253|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569254|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569255|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569256|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569257|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569258|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569259|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569260|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569261|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569262|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569263|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569264|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569265|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569266|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569267|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569268|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569400|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569269|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569270|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks
569271|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569272|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569273|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569274|NCT00077649|O4|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569275|NCT00077649|O3|Outcome|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569276|NCT00077649|O2|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-mL solution administered sc once weekly + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569277|NCT00077649|O1|Outcome|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1 mL solution administered sc, once weekly + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569278|NCT00077649|E4|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1600 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569279|NCT00077649|E3|Reported Event|PEG-IFN Alfa-2a 270 mcg + Ribavirin 1200 mg|Participants received 270 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered po daily in split doses for 48 weeks
569280|NCT00077649|E2|Reported Event|PEG-IFN Alfa-2a 180 mcg + Ribavirin 1600 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered sc once in a week + 1600 mg of ribavirin (200 mg/tablet) administered po daily in split doses for 48 weeks.
569281|NCT00077649|E1|Reported Event|PEG-IFN Alfa-2a 180 mcg +Ribavirin 1200 mg|Participants received 180 mcg of PEG-IFN alfa-2a in 1-ml solution administered [subcutaneously] sc, once in a week + 1200 mg of ribavirin (200 mg/tablet) + ribavirin placebo (2 tablets) administered [orally ] po daily in split doses for 48 weeks
569282|NCT00077636|B3|Baseline|Total|Total of all reporting groups
569283|NCT00077636|B2|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569284|NCT00077636|B1|Baseline|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569285|NCT00077636|P2|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants received 180 mcg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569286|NCT00077636|P1|Participant Flow|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants received 180 micrograms (mcg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569287|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569288|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 16 weeks.
569289|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569290|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569291|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569292|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569293|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569294|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569295|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569296|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569297|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569298|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569299|NCT00077636|O2|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569300|NCT00077636|O1|Outcome|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569301|NCT00077636|E2|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 24 Weeks|Participants were administered 180 μg of PEG-IFN alfa-2a once weekly and 800 mg of ribavirin daily for 24 weeks.
569302|NCT00077636|E1|Reported Event|PEG-IFN Alfa-2a 180μg + Ribavirin 800 mg 16 Weeks|Participants were administered 180 micrograms (μg) of PEG-IFN alfa-2a once weekly and 800 milligrams (mg) of ribavirin daily for 16 weeks.
569303|NCT00077623|B4|Baseline|Total|Total of all reporting groups
569304|NCT00077623|B3|Baseline|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569305|NCT00077623|B2|Baseline|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the Epoetin dose of<8000, 8000-16000, or >16000 IU/Week administered during the week preceding the switch to the study drug.
569306|NCT00077623|B1|Baseline|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the Epoetin dose of<8000, 8000-16000,or >16000 International units [IU]/Week, administered during the week preceding the switch to the study drug.
569307|NCT00077623|P3|Participant Flow|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569308|NCT00077623|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569309|NCT00077623|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of<8000, 8000-16000, or >16000 international units per week (IU/week), administered during the week preceding the switch to the study drug.
569310|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569311|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569312|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569313|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569314|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569315|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569316|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569317|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569318|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569319|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569320|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569321|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569322|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569323|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569324|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569325|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569326|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569327|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569328|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569329|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569330|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569331|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569332|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569333|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569334|NCT00077623|O3|Outcome|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569335|NCT00077623|O2|Outcome|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569336|NCT00077623|O1|Outcome|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569337|NCT00077623|E3|Reported Event|Epoetin Reference|Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks.
569338|NCT00077623|E2|Reported Event|RO0503821 (1x/4 Weeks)|Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week administered during the week preceding the switch to the study drug.
569339|NCT00077623|E1|Reported Event|RO0503821 (1x/2 Weeks)|Eligible participants received RO0503821 subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 mcg which was based on the epoetin dose of<8000, 8000-16000, or >16000 IU/week, administered during the week preceding the switch to the study drug.
569340|NCT00077610|B4|Baseline|Total|Total of all reporting groups
569341|NCT00077610|B3|Baseline|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569342|NCT00077610|B2|Baseline|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569343|NCT00077610|B1|Baseline|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569344|NCT00077610|P3|Participant Flow|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569345|NCT00077610|P2|Participant Flow|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569346|NCT00077610|P1|Participant Flow|RO0503821 (1x/2 Weeks)|Participants received RO0503821 (Mircera [methoxy polyethylene glycol-epoetin beta]) once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 microgram [mcg]) that was based on the Epoetin dose (<8000, 8000-16000, >16000 International units [IU]/Week) administered during the week preceding the switch to the study drug.
569347|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569348|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose administered during the week preceding the switch to the study drug.
569401|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
569402|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569349|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569350|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569351|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569352|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569353|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569354|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569355|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569356|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569357|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569358|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569359|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569360|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569361|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569362|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks
569363|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569364|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569365|NCT00077610|O3|Outcome|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569366|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569367|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 100,180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569368|NCT00077610|O3|Outcome|Epoetin (1-3x/Week)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569369|NCT00077610|O2|Outcome|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (120, 200, 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569370|NCT00077610|O1|Outcome|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants randomized received a starting dose of RO0503821 (60, 120,180 mcg) that was based on the Epoetin dose administered (<8000, 8000-16000, >16000 IU/Week) during the week preceding the switch to the study drug.
569371|NCT00077610|E3|Reported Event|Epoetin (1-3x/Weeks)|Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks.
569372|NCT00077610|E2|Reported Event|RO0503821 (1x/4 Weeks)|Participants received RO0503821 once every four weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (120, 200, or 360 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569403|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569404|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569373|NCT00077610|E1|Reported Event|RO0503821 (1x/2 Weeks)|Participants received RO0503821 once every two weeks intravenously for 52 weeks. Participants received a starting dose of RO0503821 (60, 100, or 180 mcg) that was based on the Epoetin dose (<8000, 8000-16000, >16000 IU/Week) administered during the week preceding the switch to the study drug.
569374|NCT00077376|B1|Baseline|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569375|NCT00077376|P1|Participant Flow|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569376|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569377|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569378|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569379|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569380|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569381|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569405|NCT00076999|O5|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569406|NCT00076999|O4|Outcome|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
569407|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569408|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569382|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569383|NCT00077376|O1|Outcome|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569384|NCT00077376|E1|Reported Event|Trastuzumab/Ixabepilone/Carboplatin|"During the induction phase, patients were treated with Ixabepilone (BMS-247550) 15mg/m2 intravenously (IV) followed by carboplatin (AUC=2 IV) on days 1, 8 and 15 of a 28-day cycle for a maximum of 6 cycles. Trastuzumab was administered weekly (4mg/kg loading dose then 2mg/kg IV) starting on day 1. Routine premedication included H1 blocker (diphenhydramine 50 mg orally (PO) or IV), H2 blocker (ranitidine 150 mg PO or 50 mg IV or another equivalent H2 blocker), and at least a 5-HT3 antagonist and dexamethasone.~After completion of 24 weekly trastuzumab doses (induction therapy), trastuzumab were given at a dose of 6 mg/kg IV every 3 weeks (maintenance therapy) beginning one week after the 24th weekly dose. Trastuzumab were repeated every 21 days until disease progression or prohibitive toxicity."
569385|NCT00077207|B1|Baseline|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
569386|NCT00077207|P1|Participant Flow|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
569387|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
569388|NCT00077207|O1|Outcome|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
569389|NCT00077207|E1|Reported Event|Treatment (Carboplatin, Vincristine Sulfate, Temozolomide)|"Induction therapy: Patients receive carboplatin IV (175/m2) over 1 hour on days 1, 8, 15, and 22; vincristine IV (1.5 mg/m2) on days 1, 8, 15, 22, 29, and 36; and oral temozolomide (200 mg/m2) on days 43-47. Four weeks after the completion of induction therapy, patients achieving stable or responding disease proceed to maintenance therapy. Maintenance therapy: Patients receive carboplatin (175/m2) and temozolomide (200 mg/m2) as in induction therapy and vincristine IV ((1.5 mg/m2) day 1 of weeks 10,11,12. Treatment repeats every 10 weeks for a total of 6 courses in the absence of disease progression.~carboplatin: Given IV~temozolomide: Given orally~vincristine sulfate: Given IV"
569390|NCT00076999|B5|Baseline|Total|Total of all reporting groups
569391|NCT00076999|B4|Baseline|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569392|NCT00076999|B3|Baseline|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569393|NCT00076999|B2|Baseline|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569394|NCT00076999|B1|Baseline|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569395|NCT00076999|P5|Participant Flow|TPV SEDDS 12-18 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 12-18
569396|NCT00076999|P4|Participant Flow|TPV SEDDS 6-<12 Yrs|TPV self-emulsifying drug delivery system (SEDDS), ages 6-11
569397|NCT00076999|P3|Participant Flow|TPV OS 12-18 Yrs|Tipranavir Oral Solution (TPV OS), ages 12-18
569398|NCT00076999|P2|Participant Flow|TPV OS 6-<12 Yrs|Tipranavir Oral Solution (TPV OS), ages 6-11
569399|NCT00076999|P1|Participant Flow|TPV OS 2-<6 Yrs|Tipranavir Oral Solution (TPV OS), ages 2-5
569409|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569410|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569411|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569412|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569413|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569414|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569415|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569416|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569417|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569418|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569419|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569420|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569421|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569422|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569423|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569424|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569425|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569426|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569427|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569428|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569429|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569430|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569431|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569432|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569433|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569434|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569435|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569436|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569437|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569438|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569439|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569440|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569441|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569442|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569443|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569444|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569445|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569446|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569447|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569448|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569449|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569450|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569451|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569452|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569453|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569454|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569455|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569456|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569457|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569458|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569459|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569460|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569461|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569462|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569463|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569464|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569465|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569466|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569467|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569468|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569469|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569470|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569471|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569472|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569473|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569474|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569475|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569476|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569477|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569478|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569479|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569480|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569481|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569482|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569483|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569484|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569485|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569486|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569487|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569488|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569489|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569490|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569491|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569492|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569493|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569494|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569495|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569496|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569497|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569498|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569499|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569500|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569501|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569502|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569503|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569504|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569505|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569506|NCT00076999|O4|Outcome|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569507|NCT00076999|O3|Outcome|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569508|NCT00076999|O2|Outcome|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569509|NCT00076999|O1|Outcome|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569510|NCT00076999|E5|Reported Event|TPV SEDDS 12-18 Yrs|Patients treated with Tipranavir SEDDS, ages 12-18
569511|NCT00076999|E4|Reported Event|TPV SEDDS 6-<12 Yrs|Patients treated with Tipranavir SEDDS, ages 6-11
569512|NCT00076999|E3|Reported Event|TPV OS 12-18 Yrs|Patients treated with Tipranavir Oral Solution, ages 12-18
569513|NCT00076999|E2|Reported Event|TPV OS 6-<12 Yrs|Patients treated with Tipranavir Oral Solution, ages 6-11
569514|NCT00076999|E1|Reported Event|TPV OS 2-<6 Yrs|Patients treated with Tipranavir Oral Solution, ages 2-5
569515|NCT00076804|B3|Baseline|Total|Total of all reporting groups
569516|NCT00076804|B2|Baseline|Self Administration|Self administration of ARVs
569517|NCT00076804|B1|Baseline|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569518|NCT00076804|P2|Participant Flow|Self Administration|Self administration of ARVs
569519|NCT00076804|P1|Participant Flow|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569520|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
569521|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569522|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
569523|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569524|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
569525|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569526|NCT00076804|O2|Outcome|Self Administration|Self administration of ARVs
569527|NCT00076804|O1|Outcome|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569528|NCT00076804|E2|Reported Event|Self Administration|Self administration of ARVs
569529|NCT00076804|E1|Reported Event|Peer Supporter|Use of a patient nominated peer supporter who sill observe the morning dose of ARVs
569758|NCT00075829|P4|Participant Flow|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569530|NCT00076752|B1|Baseline|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
569531|NCT00076752|P1|Participant Flow|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
569532|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
569533|NCT00076752|O1|Outcome|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, and diphenhydramine. Stem cell transplant infusion day 0, product will be infused rapidly intravenously after premedication with diphenhydramine 25-60 mg orally or intravenous."
569534|NCT00076752|E1|Reported Event|Autologous HSCT in SLE|"Autologous hematopoietic stem cell transplantation (HSCT) in systemic lupus erythematosus (SLE).~SLE is a chronic, inflammatory disease of the immune system. Participants received a priming, conditioning and transplant regimen. Priming regimen consisted of treatment with rituxan, filgrastim, cyclophosphamide, mesna, fludarabine phosphate, and methylprednisolone. Conditioning and transplant regimen consisted of fludarabine, cyclophosphamide, rituxan, filgrastim, mesna, diphenhydramine and stem cell transplant infusion."
569535|NCT00076687|B4|Baseline|Total|Total of all reporting groups
569536|NCT00076687|B3|Baseline|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569537|NCT00076687|B2|Baseline|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569538|NCT00076687|B1|Baseline|Placebo|Placebo
569539|NCT00076687|P3|Participant Flow|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569540|NCT00076687|P2|Participant Flow|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569541|NCT00076687|P1|Participant Flow|Placebo|Placebo
569542|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569543|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569544|NCT00076687|O1|Outcome|Placebo|Placebo
569545|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569546|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569547|NCT00076687|O1|Outcome|Placebo|Placebo
569548|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569549|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569550|NCT00076687|O1|Outcome|Placebo|Placebo
569551|NCT00076687|O3|Outcome|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569552|NCT00076687|O2|Outcome|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569553|NCT00076687|O1|Outcome|Placebo|Placebo
569554|NCT00076687|E3|Reported Event|Botulinum Toxin Type A 360 U|botulinum toxin Type A 360 U
569555|NCT00076687|E2|Reported Event|Botulinum Toxin Type A 240 U|botulinum toxin Type A 240 U
569556|NCT00076687|E1|Reported Event|Placebo|Placebo
569557|NCT00076570|B3|Baseline|Total|Total of all reporting groups
569558|NCT00076570|B2|Baseline|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
569559|NCT00076570|B1|Baseline|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
569560|NCT00076570|P2|Participant Flow|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
569561|NCT00076570|P1|Participant Flow|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
569562|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
569563|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
569564|NCT00076570|O2|Outcome|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
569565|NCT00076570|O1|Outcome|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
569566|NCT00076570|E2|Reported Event|Tacrolimus Group|Patients treated with tacrolimus monotherapy from 6 months after combination therapy
569567|NCT00076570|E1|Reported Event|Sirolimus Group|Patients treated with sirolimus monotherapy from 6 months after combination therapy
569568|NCT00075400|B1|Baseline|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569636|NCT00076336|E2|Reported Event|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569569|NCT00075400|P1|Participant Flow|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569570|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569571|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569572|NCT00075400|O1|Outcome|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569573|NCT00075400|E1|Reported Event|Gleevec|Gleevec™ 600 mg QD po continuously (a cycle will be defined as 28 days). If first cycle of Gleevec™ at 600 mg QD is tolerated without any significant toxicity, the dose can be escalated to 400 mg BID po Q 12 hours until disease progression or adverse effects prohibit further therapy.
569574|NCT00075270|B3|Baseline|Total|Total of all reporting groups
569575|NCT00075270|B2|Baseline|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569576|NCT00075270|B1|Baseline|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569577|NCT00075270|P2|Participant Flow|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569578|NCT00075270|P1|Participant Flow|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569579|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569580|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569581|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569582|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569583|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569584|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569585|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569586|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569587|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569588|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569589|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569804|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
569590|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569591|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569592|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569593|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569594|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569595|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569596|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569597|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569598|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569599|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569600|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569601|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569602|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569603|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569604|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569605|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569606|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569607|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569608|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569609|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569650|NCT00076245|B2|Baseline|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
569610|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569611|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569612|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569613|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569614|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569615|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569616|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 mg orally OD with paclitaxel 175 m^2 IV over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569617|NCT00075270|O2|Outcome|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569618|NCT00075270|O1|Outcome|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569619|NCT00075270|E2|Reported Event|Placebo With Paclitaxel|Participants received matching placebo orally OD with paclitaxel (175 mg/m^2 IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569620|NCT00075270|E1|Reported Event|Lapatinib With Paclitaxel|Participants received lapatinib 1500 milligrams (mg) orally once daily (OD) with paclitaxel 175 mg/meters squared (m^2) intravenously (IV) over the course of 3 hours, every 3 weeks. The treatment group was stratified by sites of metastatic disease and stage of disease. Participants were treated until disease progression, unacceptable toxicity, or consent withdrawal.
569621|NCT00076336|B3|Baseline|Total|Total of all reporting groups
569622|NCT00076336|B2|Baseline|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569623|NCT00076336|B1|Baseline|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569624|NCT00076336|P2|Participant Flow|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569625|NCT00076336|P1|Participant Flow|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569626|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569627|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569628|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569629|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569630|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569631|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569632|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569633|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569634|NCT00076336|O2|Outcome|Lamivudine 100 mg|Participants received Lamivudine 100 mg and matching placebo to Telbivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569635|NCT00076336|O1|Outcome|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569651|NCT00076245|B1|Baseline|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
569637|NCT00076336|E1|Reported Event|Telbivudine 600 mg|Participants received Telbivudine 600 mg and a matching placebo to lamivudine orally once a day for up to 104 weeks, followed by a 16-week follow-up period.
569638|NCT00076258|B3|Baseline|Total|Total of all reporting groups
569639|NCT00076258|B2|Baseline|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569640|NCT00076258|B1|Baseline|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569641|NCT00076258|P2|Participant Flow|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569642|NCT00076258|P1|Participant Flow|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569643|NCT00076258|O2|Outcome|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569644|NCT00076258|O1|Outcome|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569645|NCT00076258|E2|Reported Event|SSRI+ PHD|"A public health dose of aerobic exercise (PHD) augmentation intervention to SSRI~SSRI + PHD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569646|NCT00076258|E1|Reported Event|SSRI+ LD|"A low dose aerobic exercise (LD) augmentation intervention to SSRI~SSRI + LD: Eligible participants who have completed an adequate trial of SSRI monotherapy and all screening visits are randomly assigned to 24 weeks of SSRI augmentation with : a low dose of aerobic exercise (LD) or a public health dose of aerobic exercise (PHD). The acute phase of TREAD consists of the first 12 weeks of exercise augmentation intervention and includes: a) an individualized PHD- or LD aerobic exercise prescription; b) an empiricallybased behavioral intervention, including selfmonitoring tools and an interactive website, designed to maximize exercise adherence and minimize drop-out; and c) exercise instruction and supervised training sessions at The Cooper Institute (CI) as well as self-administered, home-based training sessions."
569647|NCT00076245|B5|Baseline|Total|Total of all reporting groups
569648|NCT00076245|B4|Baseline|4 Control|
569649|NCT00076245|B3|Baseline|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
569652|NCT00076245|P4|Participant Flow|4 Control|
569653|NCT00076245|P3|Participant Flow|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
569654|NCT00076245|P2|Participant Flow|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
569655|NCT00076245|P1|Participant Flow|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
569656|NCT00076245|O4|Outcome|4 Control|
569657|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
569658|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
569659|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
569660|NCT00076245|O4|Outcome|4 Control|
569661|NCT00076245|O3|Outcome|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
569662|NCT00076245|O2|Outcome|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
569663|NCT00076245|O1|Outcome|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
569664|NCT00076245|E4|Reported Event|4 Control|
569665|NCT00076245|E3|Reported Event|3 Light Therapy Plus Cognitive Behavioral Therapy|"Light Therapy: Light therapy will involve exposure to bright light twice a day.~Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week."
569666|NCT00076245|E2|Reported Event|2 Cognitive Behavioral Therapy|Cognitive behavioral therapy (CBT): CBT attempts to change maladaptive thoughts and beliefs, and will be conducted twice a week.
569667|NCT00076245|E1|Reported Event|1 Light Therapy|Light Therapy: Light therapy will involve exposure to bright light twice a day.
569668|NCT00076219|B3|Baseline|Total|Total of all reporting groups
569669|NCT00076219|B2|Baseline|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
569670|NCT00076219|B1|Baseline|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
569671|NCT00076219|P2|Participant Flow|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
569672|NCT00076219|P1|Participant Flow|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
569673|NCT00076219|O2|Outcome|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
569674|NCT00076219|O1|Outcome|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
569675|NCT00076219|E2|Reported Event|Less-intensive Renal Replacement Therapy|In the less-intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 3 times per week, and continuous venovenous hemodiafiltration was provided at 20 mL/kg/hour.
569676|NCT00076219|E1|Reported Event|Intensive Renal Replacement Therapy|In the intensive management strategy, intermittent hemodialysis and sustained low-efficiency dialysis were provided 6 times per week, and continuous venovenous hemodiafiltration was provided at 35 mL/kg/hour.
569677|NCT00076102|B1|Baseline|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
569678|NCT00076102|P1|Participant Flow|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
569679|NCT00076102|O1|Outcome|Pirfenidine|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
569680|NCT00076102|O1|Outcome|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
569681|NCT00076102|E1|Reported Event|Pirfenidone|Pirfenidone orally as capsules three times a day approximately every 8 hours for cycles of 28 days with no rest period between cycles (28 day treatment cycles); 500 mg/m^2 every 8 hours (1500 mg/m2/day).
569682|NCT00076050|B3|Baseline|Total|Total of all reporting groups
569683|NCT00076050|B2|Baseline|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569684|NCT00076050|B1|Baseline|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569685|NCT00076050|P2|Participant Flow|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569806|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569686|NCT00076050|P1|Participant Flow|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569687|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569688|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569689|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569690|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569691|NCT00076050|O2|Outcome|Placebo Group|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569692|NCT00076050|O1|Outcome|Soy Isoflavone Group|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569693|NCT00076050|E2|Reported Event|Placebo|A total of 126 participants were randomized to receive placebo tablets by mouth daily over 2 years.The medication was delivered in four tablets that had to be taken fasting in the morning.
569694|NCT00076050|E1|Reported Event|Soy Isoflavones|A total of 122 participants were randomized to receive a 200-mg dose of soy isoflavones in tablet form daily by mouth, over 2 years. The medication was delivered in four tablets that had to be taken fasting in the morning.
569695|NCT00076024|B4|Baseline|Total|Total of all reporting groups
569696|NCT00076024|B3|Baseline|Docetaxel + Placebo (Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued with axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
569697|NCT00076024|B2|Baseline|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569698|NCT00076024|B1|Baseline|Axitinib + Docetaxel (Phase 1, Lead-in)|Axitinib (AG-013736) 5 mg tablet orally twice daily BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
569699|NCT00076024|P4|Participant Flow|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
569700|NCT00076024|P3|Participant Flow|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
569701|NCT00076024|P2|Participant Flow|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569702|NCT00076024|P1|Participant Flow|Axitinib + Docetaxel (Phase-1, Lead-in)|Axitinib (AG-013736) 5 milligram (mg) tablet orally twice daily (BID) starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 milligram/square meter (mg/m^2) 1 hour (hr) intravenous (IV) infusion on Day 1 of each cycle, in cycles of 3 weeks.
569703|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
569704|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
569705|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569706|NCT00076024|O1|Outcome|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
569707|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
569708|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569709|NCT00076024|O2|Outcome|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
569710|NCT00076024|O1|Outcome|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569711|NCT00076024|E4|Reported Event|Axitinib (Phase 2, Open-label)|Axitinib (AG-013736) 5 mg tablet orally BID continuously in cycles of 4 weeks.
569712|NCT00076024|E3|Reported Event|Docetaxel + Placebo (Phase 2, Double-blind)|Placebo matched to axitinib (AG-013736) tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response. Participants with disease progression after consent were continued to open-label phase.
569713|NCT00076024|E2|Reported Event|Axitinib + Docetaxel (Phase 2, Double-blind)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks. Treatment was continued until disease progression, intolerable toxicity, or for 2 cycles after complete response.
569714|NCT00076024|E1|Reported Event|Axitinib + Docetaxel (Phase-1 Lead-in)|Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 3 of Cycle 1, in cycles of 3 weeks. Docetaxel 80 mg/m^2 1 hr IV infusion on Day 1 of each cycle, in cycles of 3 weeks.
569715|NCT00076011|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569716|NCT00076011|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569717|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569718|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569719|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569720|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569721|NCT00076011|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569722|NCT00076011|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) in cycles of 4 weeks. Treatment was administered continuously until progression or unacceptable toxicity occurred.
569723|NCT00075946|B5|Baseline|Total|Total of all reporting groups
569724|NCT00075946|B4|Baseline|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569725|NCT00075946|B3|Baseline|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569726|NCT00075946|B2|Baseline|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569727|NCT00075946|B1|Baseline|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569728|NCT00075946|P5|Participant Flow|Enrolled But Not Randomized|Patients who were enrolled in the study but not proceed to randomization. These could include patients with undetermined histology as well as those who did not achieve response (PR or CR) after induction rituximab.
569729|NCT00075946|P4|Participant Flow|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569730|NCT00075946|P3|Participant Flow|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569731|NCT00075946|P2|Participant Flow|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569732|NCT00075946|P1|Participant Flow|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569733|NCT00075946|O2|Outcome|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
569734|NCT00075946|O1|Outcome|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
569735|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569736|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569737|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569738|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569739|NCT00075946|O4|Outcome|Rituximab Scheduled: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569740|NCT00075946|O3|Outcome|Rituximab Retreatment: Non-Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569741|NCT00075946|O2|Outcome|Rituximab Scheduled: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity. Follicular and non-follicular patients were analyzed separately per protocol.
569742|NCT00075946|O1|Outcome|Rituximab Retreatment: Follicular Patients|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months. Follicular and non-follicular patients were analyzed separately per protocol.
569743|NCT00075946|E3|Reported Event|Arm B: Rituximab Scheduled|Following induction rituximab, patients who were randomized to this arm received a single dose of rituximab IV once every 13 weeks until disease progression and in the absence of unacceptable toxicity.
569744|NCT00075946|E2|Reported Event|Arm A: Rituximab Retreatment|Following induction rituximab, patients who were randomized to this arm received rituximab IV once a week for 4 weeks upon disease progression provided time to progression is more than 6 months.
569745|NCT00075946|E1|Reported Event|Arm I: Induction Rituximab|Patients received rituximab IV once a week for 4 weeks. Patients were re-evaluated 9 weeks after the completion of induction rituximab. Patients with a partial or complete response to induction rituximab were randomized to one of the two treatment arms.
569746|NCT00075881|B1|Baseline|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
569747|NCT00075881|P1|Participant Flow|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
569748|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
569749|NCT00075881|O1|Outcome|PS-341|Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose
569750|NCT00075881|O1|Outcome|PS-341|Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15
569751|NCT00075881|O1|Outcome|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
569752|NCT00075881|E1|Reported Event|PS-341|"Induction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose. Repeat cycles every 3 weeks for a total of 8 cycles.~Maintenance treatment: PS-341 1.3 mg/m2 IV push days 1 and 15.~Reinduction treatment: PS-341 1.3 mg/m2 IV push days 1, 4, 8, and 11. As per the PS-341 package insert, there should be at least 72 hours between each PS-341 dose."
569753|NCT00075829|B5|Baseline|Total|Total of all reporting groups
569754|NCT00075829|B4|Baseline|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569755|NCT00075829|B3|Baseline|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
569756|NCT00075829|B2|Baseline|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569757|NCT00075829|B1|Baseline|Auto-Auto Standard Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
569805|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569759|NCT00075829|P3|Participant Flow|Auto-Auto High Risk|"Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for high risk patients~PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis."
569760|NCT00075829|P2|Participant Flow|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569761|NCT00075829|P1|Participant Flow|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone (Thal-Dex) or observation (Obs) for standard risk patients PFS and OS did not differ between the Thal-Dex and the Obs arms and were thus pooled for analysis.
569762|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569763|NCT00075829|O1|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569764|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569765|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569766|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569767|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569768|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569769|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569770|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569771|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569772|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569773|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569774|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569775|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569776|NCT00075829|O2|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569777|NCT00075829|O1|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569778|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569779|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569780|NCT00075829|O4|Outcome|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569781|NCT00075829|O3|Outcome|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569782|NCT00075829|O2|Outcome|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569783|NCT00075829|O1|Outcome|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569784|NCT00075829|E4|Reported Event|Auto-Allo High Risk|Autologous transplant plus non-myeloablative allogeneic transplant for high risk patients
569785|NCT00075829|E3|Reported Event|Auto-Auto High Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for high risk patients
569786|NCT00075829|E2|Reported Event|Auto-Allo Standard Risk|Autologous transplant plus non-myeloablative allogeneic transplant for standard risk patients
569787|NCT00075829|E1|Reported Event|Auto-Auto Standard Risk|Tandem autologous transplant plus thalidomide/dexamethasone or observation for standard risk patients
569788|NCT00075816|B3|Baseline|Total|Total of all reporting groups
569789|NCT00075816|B2|Baseline|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569790|NCT00075816|B1|Baseline|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569791|NCT00075816|P2|Participant Flow|Peripheral-Blood Stem Cells|Patients who underwent transplantation of peripheral-blood stem cells from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
569792|NCT00075816|P1|Participant Flow|Bone Marrow|Patients who underwent transplantation of bone marrow from unrelated donors; all randomized patients were included in the primary, intention-to-treat analysis.
569793|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
569794|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
569795|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569796|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569797|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569798|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569799|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569800|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569801|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
569802|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
569803|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
569807|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569808|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569809|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569810|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569811|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569812|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569813|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569814|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569815|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569816|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569817|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Patients who received transplantation of peripheral-blood stem cells from unrelated donors.
569818|NCT00075816|O1|Outcome|Bone Marrow|Patients who received transplantation of bone marrow from unrelated donors.
569819|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569820|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569821|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569822|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569823|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569824|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569825|NCT00075816|O2|Outcome|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569826|NCT00075816|O1|Outcome|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569827|NCT00075816|E2|Reported Event|Peripheral-Blood Stem Cells|Peripheral blood stem cell transplant from HLA compatible unrelated donors
569828|NCT00075816|E1|Reported Event|Bone Marrow|Bone marrow transplant from HLA compatible unrelated donors
569829|NCT00075803|B3|Baseline|Total|Total of all reporting groups
569830|NCT00075803|B2|Baseline|Voriconazole|voriconazole prophylaxis
569831|NCT00075803|B1|Baseline|Fluconazole|fluconazole prophylaxis
569832|NCT00075803|P2|Participant Flow|Voriconazole|voriconazole prophylaxis
569833|NCT00075803|P1|Participant Flow|Fluconazole|fluconazole prophylaxis
569834|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569835|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569836|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569837|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569838|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569839|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569840|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569841|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569842|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569843|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569844|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569845|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569846|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569847|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569848|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569849|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569850|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569851|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569852|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569853|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569854|NCT00075803|O2|Outcome|Voriconazole|voriconazole prophylaxis
569855|NCT00075803|O1|Outcome|Fluconazole|fluconazole prophylaxis
569856|NCT00075803|E2|Reported Event|Voriconazole|voriconazole prophylaxis
569857|NCT00075803|E1|Reported Event|Fluconazole|fluconazole prophylaxis
569858|NCT00075725|B13|Baseline|Total|Total of all reporting groups
569859|NCT00075725|B12|Baseline|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth
569860|NCT00075725|B11|Baseline|Dexamethasone, Capizzi Methotrexate Down Syndrome|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569861|NCT00075725|B10|Baseline|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569862|NCT00075725|B9|Baseline|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569863|NCT00075725|B8|Baseline|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569864|NCT00075725|B7|Baseline|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569865|NCT00075725|B6|Baseline|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569866|NCT00075725|B5|Baseline|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569867|NCT00075725|B4|Baseline|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569868|NCT00075725|B3|Baseline|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569869|NCT00075725|B2|Baseline|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
570066|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
569870|NCT00075725|B1|Baseline|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569871|NCT00075725|P12|Participant Flow|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569872|NCT00075725|P11|Participant Flow|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569873|NCT00075725|P10|Participant Flow|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569874|NCT00075725|P9|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569875|NCT00075725|P8|Participant Flow|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569876|NCT00075725|P7|Participant Flow|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH (Prednisone, High Dose MTX) regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569877|NCT00075725|P6|Participant Flow|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569878|NCT00075725|P5|Participant Flow|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC (Prednisone, Capizzi) will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570067|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
570395|NCT00073008|E1|Reported Event|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570396|NCT00072761|B3|Baseline|Total|Total of all reporting groups
569879|NCT00075725|P4|Participant Flow|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569880|NCT00075725|P3|Participant Flow|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569881|NCT00075725|P2|Participant Flow|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH (High Dose) regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569882|NCT00075725|P1|Participant Flow|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569883|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569884|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569885|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569886|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569887|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570121|NCT00074711|B2|Baseline|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
569888|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569889|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569890|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569891|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569892|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569893|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569894|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569895|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569896|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570068|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
569897|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569898|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569899|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569900|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569901|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569902|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569903|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569904|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569905|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570035|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570426|NCT00072293|B3|Baseline|Total|Total of all reporting groups
569906|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569907|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569908|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569909|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569910|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569911|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569912|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569913|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569914|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
570036|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
569915|NCT00075725|O12|Outcome|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569916|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569917|NCT00075725|O10|Outcome|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569918|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569919|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569920|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569921|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569922|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569923|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
570069|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
569924|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569925|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569926|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569927|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569928|NCT00075725|O10|Outcome|Prednisone, Capizzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569929|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569930|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569931|NCT00075725|O7|Outcome|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569932|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570037|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
569933|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569934|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569935|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569936|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569937|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569938|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569939|NCT00075725|O8|Outcome|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569940|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569941|NCT00075725|O6|Outcome|Prednisone, Capizzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570038|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
569942|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569943|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569944|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569945|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569946|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569947|NCT00075725|O11|Outcome|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569948|NCT00075725|O10|Outcome|Prenisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569949|NCT00075725|O9|Outcome|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569950|NCT00075725|O8|Outcome|Prenisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
570039|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
569951|NCT00075725|O7|Outcome|Predisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569952|NCT00075725|O6|Outcome|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569953|NCT00075725|O5|Outcome|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569954|NCT00075725|O4|Outcome|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569955|NCT00075725|O3|Outcome|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569956|NCT00075725|O2|Outcome|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569957|NCT00075725|O1|Outcome|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569958|NCT00075725|E12|Reported Event|Prednisone and High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the PH regimen based on one (or more) of the following: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal MTX in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569959|NCT00075725|E11|Reported Event|Dexamethasone, Capizzi Methotrexate Down Syndrome (Non Random)|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
570040|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
569960|NCT00075725|E10|Reported Event|Prednisone, Capezzi Methotrexate (Down's Syndrome)|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569961|NCT00075725|E9|Reported Event|Dexamethasone, High Dose Methotrexate (IM) >= 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569962|NCT00075725|E8|Reported Event|Prednisone and High Dose Methotrexate >=10 Years|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569963|NCT00075725|E7|Reported Event|Prednisone and High Dose Methotrexate < 10 Yrs Old|Patients randomly assigned to the PH regimen receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569964|NCT00075725|E6|Reported Event|Prednisone, Capezzi Methotrexate >= 10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569965|NCT00075725|E5|Reported Event|Prednisone, Capizzi Methotrexate <10 Years|Patients in regimen PC will receive cytarabine, vincristine sulfate, daunorubicin hydrochloride, and pegaspargase. They will also receive prednisone by mouth or infusion twice a day in weeks 1-4 and intrathecal methotrexate in weeks 2 and 5. Some patients in all groups may receive induction therapy for 2 additional weeks. Beginning in week 6 or 7, patients may receive combination chemotherapy (vincristine sulfate, dexamethasone, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, mercaptopurine, cytarabine, thioguanine) by infusion, injection, intrathecally, and by mouth for up to 8 weeks.
569966|NCT00075725|E4|Reported Event|Dexamethasone, High Dose Methotrexate (IM) < 10 Years|Patients randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) No CNS3 status at entry, (2) no testicular leukemic involvement at entry, or (3) no extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569967|NCT00075725|E3|Reported Event|Dexamethasone & Capizzi Methotrexate Patients => 10 Years Old|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569968|NCT00075725|E2|Reported Event|Dexamethasone, High Dose Methotrexate (Non Randomly Assigned)|Patients non-randomly assigned to the DH regimen based on one (or more) of the following characteristics: (1) CNS3 status at entry, (2) testicular leukemic involvement at entry, or (3) extensive pre-treatment with steroids prior to entry. Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
570059|NCT00075218|E1|Reported Event|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
569969|NCT00075725|E1|Reported Event|Dexamethasone and Capizzi Methotrexate Patients < 10 Years|Patients receive intrathecal cytarabine (Age-based dosing: Age (yrs) Dose 1 - 1.99 30 mg 2 - 2.99 50 mg ≥ 3 70 mg) on day 1; infusions of vincristine sulfate 1.5 mg/m2/dose (maximum dose of 2 mg) on Days 1, 8, 15 and 22 and daunorubicin hydrochloride (25 mg/m2/dose on Days 1, 8, 15 and 22. Dexamethasone (5 mg/m2/dose on Days 1-14 by mouth or infusion twice a day in weeks 1 and 2; intrathecal methotrexate (Aged based dosing: Age (yrs) Dose 1 - 1.99 8 mg 2 - 2.99 10 mg 3 - 8.99 12 mg ≥ 9 15 mg) on days 8 and 29 (CNS3 also on days 15 & 22) and an injection of pegaspargase (2500 International units/m2 x 1 dose on Day 4, 5 or 6).
569970|NCT00075608|B1|Baseline|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
569971|NCT00075608|P1|Participant Flow|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
569972|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to SCC through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
569973|NCT00075608|O1|Outcome|2nd SCT|"Mobilization with filgrastim Second autologous peripheral blood stem cell transplant with melphalan conditioning~filgrastim: 16mcg/kg IV daily beginning three days prior to stem cell collection through last day of SCC~melphalan: 140-200 mcg/kg IV over two days~autologous bone marrow transplantation: infusion of previously collected stem cells on Day 0~peripheral blood stem cell transplantation: infusion of previously collected stem cells on Day 0"
569974|NCT00075608|O1|Outcome|Second Transplant|Participants underwent a second treatment with high dose chemotherapy and stem cell transplant
569975|NCT00075608|E1|Reported Event|Second Transplant|Participants who received a second transplant
569976|NCT00075582|B3|Baseline|Total|Total of all reporting groups
569977|NCT00075582|B2|Baseline|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569978|NCT00075582|B1|Baseline|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569979|NCT00075582|P2|Participant Flow|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569980|NCT00075582|P1|Participant Flow|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569981|NCT00075582|O1|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569982|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
570060|NCT00075088|B3|Baseline|Total|Total of all reporting groups
570061|NCT00075088|B2|Baseline|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
570119|NCT00074815|E1|Reported Event|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
569983|NCT00075582|O2|Outcome|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569984|NCT00075582|O1|Outcome|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569985|NCT00075582|E2|Reported Event|Regimen II (Chemotherapy, Radiotherapy, Surgery)|"Patients receive VAC chemotherapy and radiation therapy as in regimen I and VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21, 25-33, and 37-45 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, and 46 (dactinomycin is omitted during radiation therapy). Some patients do not receive radiation therapy; some start it at week 13 and some at week 24. Some patients have conventional surgery (second-look) at Week 13 (closed to accrual as of 9/23/2011).~conventional surgery: Some patients may undergo second-look surgery~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569986|NCT00075582|E1|Reported Event|Regimen I (Chemotherapy, Radiotherapy)|"Patients receive VAC chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 1-9 and dactinomycin IV over 1 minute and cyclophosphamide IV over 1 hour on day 1 of weeks 1, 4, 7, and 10; VA chemotherapy comprising vincristine sulfate IV over 1 minute on day 1 of weeks 13-21 and dactinomycin IV over 1 minute on day 1 of weeks 13, 16, 19, and 22 (dactinomycin is omitted during radiation therapy); and radiation therapy, 5 days a week, beginning on week 13 and continuing for 4-7 weeks, depending on prescribed dose. Some patients do not receive radiation therapy; some start it at week 24. (closed to accrual as of 08/13/2010)~dactinomycin: Given IV~cyclophosphamide: Given IV~vincristine sulfate: Given IV~radiation therapy: Undergo radiotherapy"
569987|NCT00075504|B3|Baseline|Total|Total of all reporting groups
569988|NCT00075504|B2|Baseline|Stratum B Abnormal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569989|NCT00075504|B1|Baseline|Stratum A Normal Liver Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569990|NCT00075504|P2|Participant Flow|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569991|NCT00075504|P1|Participant Flow|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569992|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569993|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569994|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569995|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569996|NCT00075504|O2|Outcome|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569997|NCT00075504|O1|Outcome|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569998|NCT00075504|E2|Reported Event|Stratum B Abnormal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
569999|NCT00075504|E1|Reported Event|Stratum A Normal Liver Function Triapine, Gemcitabine|"Triapine IV over 4 hours followed by gemcitabine IV over 30 minutes on days 1, 8, and 15, repeat every 28 days~triapine: Given IV~gemcitabine: Given IV"
570000|NCT00075478|B3|Baseline|Total|Total of all reporting groups
570001|NCT00075478|B2|Baseline|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570062|NCT00075088|B1|Baseline|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
570063|NCT00075088|P2|Participant Flow|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
570002|NCT00075478|B1|Baseline|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570003|NCT00075478|P2|Participant Flow|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570004|NCT00075478|P1|Participant Flow|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570005|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570006|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570007|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570008|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570009|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570010|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570011|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570012|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570013|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570014|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570015|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570016|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570017|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570018|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570019|NCT00075478|O2|Outcome|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570120|NCT00074711|B3|Baseline|Total|Total of all reporting groups
570020|NCT00075478|O1|Outcome|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570021|NCT00075478|E2|Reported Event|Arm II (TBI, Transplant, GVHD Prophylaxis)|"Patients undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570022|NCT00075478|E1|Reported Event|Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)|"Patients receive fludarabine phosphate IV on days -4 to -2. Patients then undergo low-dose TBI on day 0. After TBI, patients undergo PBSCT on day 0. Patients receive cyclosporine PO BID on days -3 to 56 in the absence of GVHD. Patients with no evidence of GVHD at day 56 begin a cyclosporine taper and continue the taper until day 180. Patients with evidence of disease progression and no evidence of GVHD prior to day 56 receive tapered doses of cyclosporine for 2 weeks. Patients also receive MMF PO BID on days 0-28 in the absence of GVHD. If treatment for GVHD is required before day 28, MMF is continued until a steroid taper begins.~total-body irradiation: Undergo TBI~fludarabine phosphate: Given IV~mycophenolate mofetil: Given PO~cyclosporine: Given PO~peripheral blood stem cell transplantation: Undergo transplantation"
570023|NCT00075218|B3|Baseline|Total|Total of all reporting groups
570024|NCT00075218|B2|Baseline|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570025|NCT00075218|B1|Baseline|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570026|NCT00075218|P3|Participant Flow|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
570027|NCT00075218|P2|Participant Flow|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570028|NCT00075218|P1|Participant Flow|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570029|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570030|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570031|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570032|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570033|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570034|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570064|NCT00075088|P1|Participant Flow|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
570503|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
570041|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570042|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570043|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570044|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570045|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570046|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570047|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570048|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570049|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570050|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570051|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570052|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570053|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570054|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570055|NCT00075218|O2|Outcome|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570056|NCT00075218|O1|Outcome|Sunitinib Double-Blind Treatment|Starting dose: 50 mg orally once daily as a single agent for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks. (Schedule 4/2). Subjects received best supportive care in addition to the study treatment.
570057|NCT00075218|E3|Reported Event|Sunitinib Open-Label Treatment|Subjects experiencing disease progression could have their treatment assignment unblinded, and subjects who had been receiving placebo could crossover to open-label treatment with sunitinib; subjects who had been receiving sunitinib during double-blind treatment of the study could continue to do so after unblinding if, in the opinion of the investigator, there was sufficient evidence of clinical benefit.
570058|NCT00075218|E2|Reported Event|Placebo Double-Blind Treatment|Starting daily dose of 1 capsule, size- and color-matched to the sunitinib 50-mg capsule for 4 consecutive weeks followed by a 2-week off-treatment period to form a complete cycle of 6 weeks (Schedule 4/2). Subjects received best supportive care in addition to the study treatment. Subjects were provided the opportunity to receive open-label sunitinib at the time of confirmed disease progression or study unblinding.
570065|NCT00075088|O2|Outcome|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
570070|NCT00075088|O1|Outcome|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
570071|NCT00075088|E3|Reported Event|Prehospital|"At the start of the trial, the IRB requested every death in the pre-hospital period be reported because we put on the study electrocardiogram device in the field with waiver of consent so as not to cause a delay for patients reaching the hospital with possible heart attack. They were consented after they reached the hospital. However, IRB removed this requirement after 40 pre-consent/pre-hospital deaths were reported. The number of pre-hospital participants assessed before and after the IRB changed the reporting requirements cannot be determined from study data, but NA is not a valid entry in the At Risk field."
570072|NCT00075088|E2|Reported Event|Routine Clinical Practice|Control patients had an ECG conducted after hospital arrival, as was the standard of care in the county.
570073|NCT00075088|E1|Reported Event|Electrocardiogram (ECG) Intervention|Patients randomized to the experimental group had their ECGs printed out in the target ED with an audible voice alarm. Print-out of the pre-hospital ECG in the target ED was the intervention.
570074|NCT00075023|B3|Baseline|Total|Total of all reporting groups
570075|NCT00075023|B2|Baseline|Placebo|Placebo Gel
570076|NCT00075023|B1|Baseline|Thalidomide Gel|Thalidomide Gel
570077|NCT00075023|P2|Participant Flow|Placebo|Placebo Gel
570078|NCT00075023|P1|Participant Flow|Thalidomide Gel|Thalidomide Gel
570079|NCT00075023|O2|Outcome|Placebo|Placebo Gel
570080|NCT00075023|O1|Outcome|Thalidomide Gel|Thalidomide Gel
570081|NCT00075023|E3|Reported Event|Adverse Events for All Participants|These are adverse events for participants as reported to the DSMB, without information related to treatment arm
570082|NCT00075023|E2|Reported Event|Placebo|Placebo Gel
570083|NCT00075023|E1|Reported Event|Thalidomide Gel|Thalidomide Gel
570084|NCT00074984|B3|Baseline|Total|Total of all reporting groups
570085|NCT00074984|B2|Baseline|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570086|NCT00074984|B1|Baseline|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570087|NCT00074984|P2|Participant Flow|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570088|NCT00074984|P1|Participant Flow|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570089|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570090|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570091|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570092|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570093|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570094|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570095|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570096|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570097|NCT00074984|O2|Outcome|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme (agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570098|NCT00074984|O1|Outcome|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks.
570099|NCT00074984|E3|Reported Event|Total|All patients.
570100|NCT00074984|E2|Reported Event|Placebo|Patients randomized to placebo are administered 1 mg/kg placebo intravenously every 2 weeks
570101|NCT00074984|E1|Reported Event|Fabrazyme (Agalsidase Beta)|Patients randomized to Fabrazyme(agalsidase beta) are administered 1mg/kg Fabrazyme (agalsidase beta) every 2 weeks.
570102|NCT00074958|B1|Baseline|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
570103|NCT00074958|P1|Participant Flow|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
570104|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
570105|NCT00074958|O1|Outcome|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
570106|NCT00074958|E1|Reported Event|Fabrazyme|1.0 mg/kg of Fabrazyme given to the patients every 2 weeks.
570107|NCT00074815|B4|Baseline|Total|Total of all reporting groups
570108|NCT00074815|B3|Baseline|MM Only|Participants will receive medication management only
570109|NCT00074815|B2|Baseline|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
570110|NCT00074815|B1|Baseline|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
570111|NCT00074815|P3|Participant Flow|MM Only|Participants will receive medication management only
570112|NCT00074815|P2|Participant Flow|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
570113|NCT00074815|P1|Participant Flow|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
570114|NCT00074815|O3|Outcome|MM Only|Participants will receive medication management only
570115|NCT00074815|O2|Outcome|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
570116|NCT00074815|O1|Outcome|MM + CBT|Participants will receive medication management plus cognitive behavioral therapy with a psychologist
570117|NCT00074815|E3|Reported Event|MM Only|Participants will receive medication management only
570118|NCT00074815|E2|Reported Event|MM + ICBT|Participants will receive medication management plus instructional cognitive behavioral therapy with a psychiatrist
570122|NCT00074711|B1|Baseline|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570123|NCT00074711|P2|Participant Flow|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570124|NCT00074711|P1|Participant Flow|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570125|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570126|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570127|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570128|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570129|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570130|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570131|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570132|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570133|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570134|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570135|NCT00074711|O2|Outcome|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570136|NCT00074711|O1|Outcome|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570137|NCT00074711|E2|Reported Event|Calcium Carbonate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium carbonate.
570138|NCT00074711|E1|Reported Event|Calcium Phosphate Treatment Group|Participants will receive teriparatide and vitamin D during the course of the 12-month study. They will also receive calcium phosphate.
570139|NCT00074581|B3|Baseline|Total|Total of all reporting groups
570140|NCT00074581|B2|Baseline|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
570141|NCT00074581|B1|Baseline|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
570142|NCT00074581|P2|Participant Flow|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
570143|NCT00074581|P1|Participant Flow|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
570144|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
570174|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
570145|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
570146|NCT00074581|O2|Outcome|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
570147|NCT00074581|O1|Outcome|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
570148|NCT00074581|E2|Reported Event|Delayed-ART|"Participants will receive HIV primary care. When the CD4 count in these participants reaches 200 to 250 cells/mm3, drops below 200 cells/mm3, or develops an AIDS-defining illness, they will initiate ART.~(Same drug regimen as that described in the early-ART arm)~Note: Per LoA#5, on the Data and Safety and Monitoring Board (DSMB) recommendation, as of May 10, 2011, all HIV-infected participants in Arm 2 who have not already initiated ART will be offered ART as soon as possible."
570149|NCT00074581|E1|Reported Event|Early-ART|"Participants will begin ART in addition to receiving HIV primary care~Atazanavir: 300 mg taken orally once daily~Didanosine: 400 mg taken orally once daily~Efavirenz: 600 mg taken orally once daily~Emtricitabine/Tenofovir disoproxil fumarate: 200 mg emtricitabine/ 300 mg tenofovir disoproxil fumarate tablet taken orally once daily~Lamivudine: 300 mg taken orally once daily~Lopinavir/Ritonavir: 200 mg lopinavir/ 50 mg ritonavir tablet taken orally once daily~Nevirapine: 200 mg taken orally once daily for 14 days followed by 200 mg taken orally twice daily~Stavudine: Dosage depends on weight~Tenofovir disoproxil fumarate: 300 mg taken orally once daily~Zidovudine/Lamivudine: 150 mg lamivudine/ 300 mg zidovudine tablet taken orally twice daily~Note: Sites could also use locally supplied, FDA-approved drugs if they could be purchased with nonstudy funds. For participants with virologic failure, specified second-line treatment regimens were provided."
570150|NCT00074412|B3|Baseline|Total|Total of all reporting groups
570151|NCT00074412|B2|Baseline|Placebo|For infants: extended treatment with NVP placebo
570152|NCT00074412|B1|Baseline|Nevirapine|For infants: extended treatment with NVP
570153|NCT00074412|P2|Participant Flow|Nevirapine|For infants: extended treatment with NVP
570154|NCT00074412|P1|Participant Flow|Placebo|For infants: extended treatment with NVP placebo
570155|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
570156|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
570157|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
570158|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
570159|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
570160|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
570161|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP placebo
570162|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
570163|NCT00074412|O2|Outcome|Placebo|For infants: extended treatment with NVP Placebo
570164|NCT00074412|O1|Outcome|Nevirapine|For infants: extended treatment with NVP
570165|NCT00074412|E2|Reported Event|Placebo|For infants: extended treatment with NVP placebo
570166|NCT00074412|E1|Reported Event|Nevirapine|For infants: extended treatment with NVP
570167|NCT00074269|B1|Baseline|Pilot Study of Allogeneic Transplant for Metastatic Breast Can|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
570168|NCT00074269|P1|Participant Flow|Treatment|"anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
570169|NCT00074269|O1|Outcome|Treatment|"Toxicity~anti-thymocyte globulin~filgrastim~graft-versus-tumor induction therapy~therapeutic allogeneic lymphocytes~cyclosporine~fludarabine phosphate~melphalan~methotrexate~peripheral blood stem cell transplantation"
570170|NCT00074269|E1|Reported Event|Treatment|"incidence of Toxicity~administration of filgrastim~Grade of GVHD~Initiation of graft-versus-tumor induction therapy~Disease Status"
570171|NCT00074165|B1|Baseline|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
570172|NCT00074165|P1|Participant Flow|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
570173|NCT00074165|O1|Outcome|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
570504|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
570175|NCT00074165|E1|Reported Event|Rituximab and Carboplatin|Rituximab: (i.v.) 375 mg/m^2 given the evening before blood brain barrier disruption(BBBD) procedure day 1 Carboplatin: (i.a.) 200 mg/m^2 /day x 2 days = 400 mg/m^2
570176|NCT00074152|B3|Baseline|Total|Total of all reporting groups
570177|NCT00074152|B2|Baseline|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570178|NCT00074152|B1|Baseline|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570179|NCT00074152|P2|Participant Flow|Chemotherapy|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570180|NCT00074152|P1|Participant Flow|Observation|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570181|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570182|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570183|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570184|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation).Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570185|NCT00074152|O2|Outcome|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570186|NCT00074152|O1|Outcome|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570187|NCT00074152|E2|Reported Event|Arm II|"Chemotherapy (+/- Radiation). Within 10 weeks after surgery, patients receive at least 3 courses of an adjuvant chemotherapy regimen as determined by the investigator. Patients may receive radiotherapy within 6 months after surgery and after the completion of chemotherapy OR integrated with chemotherapy.~chemotherapy: Given within 10 weeks after surgery."
570188|NCT00074152|E1|Reported Event|Arm I|"Observation (+/- Radiation). Patients receive radiotherapy* within 6 months after surgery.~radiation therapy: Given within 6 months after surgery"
570189|NCT00073983|B1|Baseline|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
570190|NCT00073983|P1|Participant Flow|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
570191|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
570192|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
570193|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
570194|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
570195|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
570196|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
570197|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
570198|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
570199|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
570200|NCT00073983|O3|Outcome|Chondrosarcoma|Combination chemotherapy
570201|NCT00073983|O2|Outcome|Osteosarcoma|Combination Chemotherapy
570202|NCT00073983|O1|Outcome|Ewing's Sarcoma|Combination chemotherapy
570203|NCT00073983|E1|Reported Event|Combination Chemotherapy|Gemcitibine 675 mg/m^2 given intravenous (IV) on day 1 and 8; docetaxel 75 mg/m^2 given IV on day 8 after gemcitibine. Each cycle is 21 days. Cycles of chemotherapy administered until off study criteria met.
570204|NCT00073918|B1|Baseline|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
570205|NCT00073918|P1|Participant Flow|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
570505|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
570206|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
570207|NCT00073918|O1|Outcome|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
570208|NCT00073918|E1|Reported Event|Treatment (Radio Labeled Monoclonal Antibody, Chemotherapy)|"RADIOIMMUNOTHERAPY: Patients receive a test dose of iodine I 131 tositumomab IV on day -24 to determine biodistribution. Patients then receive therapeutic iodine I 131 tositumomab IV over approximately 40-60 minutes on day -14 and are entered into radiation isolation until day -4.~CHEMOTHERAPY: Patients receive etoposide IV on day -4 and cyclophosphamide IV on day -2.~AUTOLOGOUS STEM CELL TRANSPLANTATION: Patients undergo autologous peripheral blood stem cell transplantation on day 0.~cyclophosphamide: Given IV~etoposide: Given IV~iodine I 131 tositumomab: Given IV~quality-of-life assessment: Ancillary study~peripheral blood stem cell transplantation: Undergo ASCT given via central catheter"
570209|NCT00073528|B3|Baseline|Total|Total of all reporting groups
570210|NCT00073528|B2|Baseline|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570211|NCT00073528|B1|Baseline|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570212|NCT00073528|P2|Participant Flow|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570213|NCT00073528|P1|Participant Flow|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570214|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570215|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570216|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570217|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570218|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570219|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570220|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570221|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570222|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570223|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570224|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570225|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570226|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570227|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570228|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570229|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570230|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570231|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570232|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570233|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570234|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570235|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570236|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570237|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570238|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570239|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570240|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570241|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570242|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570243|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570244|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570245|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570246|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570247|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570248|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570249|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570250|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570251|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570252|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570253|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570254|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570255|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570256|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570257|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570258|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570259|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570260|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570261|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570262|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570263|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570264|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570265|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570266|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570267|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570268|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570269|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570270|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570271|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570272|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570273|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570274|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570275|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570276|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570277|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570278|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570279|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570280|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570281|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570282|NCT00073528|O2|Outcome|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570283|NCT00073528|O1|Outcome|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570284|NCT00073528|E2|Reported Event|Letrozole 2.5 mg Plus Lapatinib 1500 mg|Participants received 6 tablets of lapatinib orally daily (250 mg lapatinib/tablet for a total of 1500 mg of lapatinib/day; approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 mg orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570285|NCT00073528|E1|Reported Event|Letrozole 2.5 mg Plus Placebo|Participants received 6 tablets of placebo, identical in appearance to lapatinib tablets, orally daily (approximately at the same time each day), either 1 hour (or more) before breakfast or 1 hour (or more) after breakfast. Participants also received 1 tablet of letrozole 2.5 milligrams (mg) orally daily, preferably with the daily dose of lapatinib. The maximum treatment period was up to 46 months.
570286|NCT00073333|B4|Baseline|Total|Total of all reporting groups
570287|NCT00073333|B3|Baseline|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
570288|NCT00073333|B2|Baseline|2Imaginal and in Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
570289|NCT00073333|B1|Baseline|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
570290|NCT00073333|P3|Participant Flow|3Attention Placebo|Placebo - attention placebo control condition consisting of weekly telephone contact of ten minutes during which clinical status, particularly level of depression was assessed. There was no other contact
570291|NCT00073333|P2|Participant Flow|2Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week for entire study. Imaginal was instituted first followed by in vivo exposure in the form of programmed practice
570292|NCT00073333|P1|Participant Flow|1Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week. Social Skills was conducted in groups of 4-6 participants. Exposure was individual therapy conducted weekly.
570293|NCT00073333|O3|Outcome|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
570294|NCT00073333|O2|Outcome|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
570295|NCT00073333|O1|Outcome|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
570296|NCT00073333|E3|Reported Event|Attention Placebo Control|Placebo - attention placebo control condition consisting of weekly telephone contact
570297|NCT00073333|E2|Reported Event|Imaginal and In Vivo Exposure|Exposure treatment - imaginal and in vivo exposure conducted twice per week
570298|NCT00073333|E1|Reported Event|Social Effectiveness Therapy|Social skills training and exposure therapy - each conducted once per week.
570299|NCT00073307|B3|Baseline|Total|Total of all reporting groups
570300|NCT00073307|B2|Baseline|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570301|NCT00073307|B1|Baseline|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570302|NCT00073307|P3|Participant Flow|Placebo Randomized, Switch to Sorafenib; Sorafenib Period Only|Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily).
570303|NCT00073307|P2|Participant Flow|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570304|NCT00073307|P1|Participant Flow|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily).
570305|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570306|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570307|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570308|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570309|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
570310|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570311|NCT00073307|O2|Outcome|Placebo|Placebo tablets matching in appearance were to be orally administered twice a day.
570312|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570313|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570314|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570315|NCT00073307|O2|Outcome|Placebo|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570316|NCT00073307|O1|Outcome|Sorafenib (Nexavar, BAY43-9006)|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Dose modification due to toxicity was permitted.
570317|NCT00073307|E4|Reported Event|Placebo ~31May2005, Then Switched to Sorafenib Only-30Jun2008|Sorafenib period only-30Jun2008: Subjects received matching placebo tablets administered orally twice a day(as of ~31 May 2005) when after unblinding subjects switched over to receive Sorafenib orally administered as 2 x 200 mg tablets bid (twice daily). Open Label/Sorafenib only period-30Jun2008
570318|NCT00073307|E3|Reported Event|Sorafenib (Nexavar, BAY43-9006)-30Jun2008|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind-30Jun2008. In addition, 1 participant who was not randomized to double-blind treatment received sorafenib treatment on a compassionate-use basis in the open-label/Sorafenib only phase and was included in the safety population only. Participants affected may deviate from double-blind phase due to data update and cleaning.
570319|NCT00073307|E2|Reported Event|Placebo-31May2005 DB|Subjects received matching placebo tablets administered orally twice a day. [until ~31 May 2005]
570320|NCT00073307|E1|Reported Event|Sorafenib (Nexavar, BAY43-9006)-31May2005 DB|Sorafenib was to be orally administered as 2 x 200 mg tablets bid (twice daily). Double Blind period-31May2005
570340|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570321|NCT00073073|B1|Baseline|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570322|NCT00073073|P1|Participant Flow|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570323|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570324|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570325|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570326|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570327|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570328|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570329|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570330|NCT00073073|O1|Outcome|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570331|NCT00073073|E1|Reported Event|Exemestane|"exemestane 25 mg by mouth (PO) every day for two years taken with calcium carbonate 1200 mg PO every day and vitamin D 400 IU PO every day Initially patients were initially planned to receive Celecoxib but the study was amended prior to any subject going on and Celecoxib was never administered to any subjects.~Exemestane: exemestane 25 mg by mouth (PO) every day for two years~Calcium carbonate: calcium carbonate 1200 mg PO every day x 2 years~Vitamin D: Vitamin D 400 international units PO every day x 2 years"
570332|NCT00073021|B3|Baseline|Total|Total of all reporting groups
570333|NCT00073021|B2|Baseline|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570334|NCT00073021|B1|Baseline|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570335|NCT00073021|P2|Participant Flow|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570336|NCT00073021|P1|Participant Flow|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570337|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570338|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570339|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570394|NCT00073008|E2|Reported Event|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570341|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570342|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570343|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570344|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570345|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570346|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570347|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570348|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570349|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570350|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570351|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570352|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570353|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570354|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570355|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570356|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570357|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570358|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570359|NCT00073021|O2|Outcome|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570360|NCT00073021|O1|Outcome|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570361|NCT00073021|E2|Reported Event|Asacol 4.8 g/Day|Two 800 mg Asacol tablets and 2 placebo tablets (matching 400 mg formulation) taken 3 times daily (morning, midday, evening).
570362|NCT00073021|E1|Reported Event|Asacol 2.4 g/Day|Two 400 mg Asacol tablets and 2 placebo tablets (matching 800 mg formulation) taken 3 times daily (morning, midday, evening).
570363|NCT00073008|B3|Baseline|Total|Total of all reporting groups
570364|NCT00073008|B2|Baseline|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570365|NCT00073008|B1|Baseline|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570366|NCT00073008|P2|Participant Flow|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570367|NCT00073008|P1|Participant Flow|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570368|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570369|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570370|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570371|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570372|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570373|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570374|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570375|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570376|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570377|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570378|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570379|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570380|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570381|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570382|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570383|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570384|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570385|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570386|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570387|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570388|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570389|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570390|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570391|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570392|NCT00073008|O2|Outcome|Lapatinib 500 mg BID|Oral lapatinib 500 mg twice daily (BID)
570393|NCT00073008|O1|Outcome|Lapatinib 1500 mg QD|Oral lapatinib 1500 mg once daily (QD)
570397|NCT00072761|B2|Baseline|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
570398|NCT00072761|B1|Baseline|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
570399|NCT00072761|P2|Participant Flow|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
570400|NCT00072761|P1|Participant Flow|Transfusion Group|The transfusion group received blood transfusion therapy every 4-6 weeks for 36 months.
570401|NCT00072761|O2|Outcome|Observation Group|The observation group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
570402|NCT00072761|O1|Outcome|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
570403|NCT00072761|E2|Reported Event|Observation Group|The observation Group received standard care therapy and quarterly physical examination by a study hematologist for 36 months.
570404|NCT00072761|E1|Reported Event|Transfusion Group|The transfusion Group received blood transfusion therapy every 4-6 weeks for 36 months.
570405|NCT00072566|B1|Baseline|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570406|NCT00072566|P1|Participant Flow|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570407|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570408|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570409|NCT00072566|O1|Outcome|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570410|NCT00072566|E1|Reported Event|Treatment (Bevacizumab, Cyclophosphamide)|"Patients receive 10 mg/kg bevacizumab IV over 30-90 minutes on days 1, 8, and 15 for the first course and on days 1 and 15 for all subsequent courses. Patients also receive low-dose oral cyclophosphamide 50 mg/d on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV~cyclophosphamide: Given PO"
570411|NCT00072475|B1|Baseline|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570412|NCT00072475|P1|Participant Flow|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO~After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570413|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570414|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570415|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570416|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570417|NCT00072475|O1|Outcome|Vatalanib|"Adult patients with MDS receive treatment with vatalanib.~vatalanib: Pts registered before 1/15/05 1250 mg/day PO After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)"
570418|NCT00072475|E1|Reported Event|Vatalanib|After 1/15/05: Start w/ 750 mg/day PO; escalate q 4 wks in absence of Grade 2 or > tox (1st increase=1000mg/day; 2nd increase 1250 mg/day)
570419|NCT00072449|B1|Baseline|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570420|NCT00072449|P1|Participant Flow|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570421|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570422|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570423|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570424|NCT00072449|O1|Outcome|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570425|NCT00072449|E1|Reported Event|Rituximab Monotherapy|Rituximab administered at a dose of 375mg/m2 as a single IV infusion every week for up to 8 weeks
570427|NCT00072293|B2|Baseline|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570428|NCT00072293|B1|Baseline|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570429|NCT00072293|P2|Participant Flow|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570430|NCT00072293|P1|Participant Flow|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570431|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570432|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570433|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570434|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570435|NCT00072293|O2|Outcome|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570436|NCT00072293|O1|Outcome|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570437|NCT00072293|E2|Reported Event|No Axillary Dissection|"Patients undergo surgical resection of the primary tumor with no axillary lymph node dissection following sentinel lymph node assessment.~No axillary lymph node dissection: Therapeutic conventional surgery"
570438|NCT00072293|E1|Reported Event|Axillary Dissection|"Patients undergo surgical resection of the primary tumor with axillary lymph node dissection following sentinel lymph node assessment.~Axillary lymph node dissection: Axillary lymph node dissection"
570439|NCT00072280|B3|Baseline|Total|Total of all reporting groups
570440|NCT00072280|B2|Baseline|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
570441|NCT00072280|B1|Baseline|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
570442|NCT00072280|P2|Participant Flow|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
570443|NCT00072280|P1|Participant Flow|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
570444|NCT00072280|O1|Outcome|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
570445|NCT00072280|E2|Reported Event|Surgery Only|Comprised of patients with initially resectable disease lesions. All patients undergo Conventional Surgery. Those with a result of clear or microscopically positive margins remain on study in this arm, for observation with no further intervention.
570446|NCT00072280|E1|Reported Event|Chemotherapy Plus Possible Surgery|"Comprised of patients with disease lesions that are initially unresectable, or resected but with resulting grossly positive margins. All patients receive vincristine sulfate, dactinomycin, and cyclophosphamide (VAC), and mercaptoethane sulfonate (MESNA). Depending on response, patients may receive ifosfamide and etoposide (IE). Filgrastim may also be given, as needed. In addition to Chemotherapy, patients may receive Conventional Surgery.~(See Interventions section for drug dosage and administration details.)"
570447|NCT00072189|B1|Baseline|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570448|NCT00072189|P1|Participant Flow|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570506|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
570507|NCT00071890|O1|Outcome|Interleukin-2 Group|HAART and tree cycles of IL-2
570449|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570450|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570451|NCT00072189|O1|Outcome|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570452|NCT00072189|E1|Reported Event|Arm 1|"Patients receive UCN-01 IV at 90 mg/m2 over 3 hours on cycle 1, reduced to 45 mg/m2 over 3 hours for subsequent cycles. Cycles repeat every 21 days in the absence of disease progression or unacceptable toxicity.~7-hydroxystaurosporine: Given IV~laboratory biomarker analysis: Correlative studies~pharmacological study: Correlative studies"
570453|NCT00072176|B3|Baseline|Total|Total of all reporting groups
570454|NCT00072176|B2|Baseline|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570455|NCT00072176|B1|Baseline|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570456|NCT00072176|P2|Participant Flow|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570457|NCT00072176|P1|Participant Flow|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570458|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570459|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570460|NCT00072176|O2|Outcome|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570461|NCT00072176|O1|Outcome|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570462|NCT00072176|E2|Reported Event|Group B|"Chemotherapy treated patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570463|NCT00072176|E1|Reported Event|Group A|"Chemotherapy naive patients receive temsirolimus IV over 30 minutes on days 1, 8, 15, and 22. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~temsirolimus: Given IV~laboratory biomarker analysis: Correlative studies"
570464|NCT00071981|B5|Baseline|Total|Total of all reporting groups
570465|NCT00071981|B4|Baseline|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570466|NCT00071981|B3|Baseline|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570467|NCT00071981|B2|Baseline|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570468|NCT00071981|B1|Baseline|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570469|NCT00071981|P4|Participant Flow|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570508|NCT00071890|E2|Reported Event|Control Group|HAART alone (without Interleukin-2)
570470|NCT00071981|P3|Participant Flow|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570471|NCT00071981|P2|Participant Flow|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570472|NCT00071981|P1|Participant Flow|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570473|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570474|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570475|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570476|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570477|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570478|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570479|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570480|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570481|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570482|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570483|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570484|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570485|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570486|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570487|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570488|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570489|NCT00071981|O4|Outcome|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570490|NCT00071981|O3|Outcome|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570491|NCT00071981|O2|Outcome|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570492|NCT00071981|O1|Outcome|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570493|NCT00071981|E4|Reported Event|Arm IV (6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising melanoma helper peptide vaccine (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570494|NCT00071981|E3|Reported Event|Arm III (12MP/6MHP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 6 melanoma helper peptides (6HP) emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~melanoma helper peptide vaccine : Given by injection"
570495|NCT00071981|E2|Reported Event|Arm II (12MP/Tet)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising multi-epitope melanoma peptide vaccine (12MP) and 1 tetanus peptide melanoma vaccine emulsified with GM-CSF and ISA-51 (incomplete Freund's adjuvant) ID and SC on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection~tetanus peptide melanoma vaccine : Given by injection"
570496|NCT00071981|E1|Reported Event|Arm I (12MP)|"Patients receive 2 injections of multi-epitope peptide vaccine comprising 12 melanoma peptides restricted by Class I MHC (12MP) emulsified with sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's adjuvant) or Montanide ISA-51 VG (ISA-51) intradermally (ID) and subcutaneously (SC) on day 1 of weeks 1-3 and 1 injection at the primary site only on day 1 of weeks 5-7.~multi-epitope melanoma peptide vaccine : Given by injection~incomplete Freund's adjuvant : Given by injection~sargramostim : Given by injection"
570497|NCT00071890|B3|Baseline|Total|Total of all reporting groups
570498|NCT00071890|B2|Baseline|Control Group|HAART alone (without Interleukin-2)
570499|NCT00071890|B1|Baseline|Interleukin-2 Group|HAART and tree cycles of IL-2
570500|NCT00071890|P2|Participant Flow|Control Group|HAART alone (without Interleukin-2)
570501|NCT00071890|P1|Participant Flow|Interleukin-2 Group|HAART and tree cycles of IL-2
570502|NCT00071890|O2|Outcome|Control Group|HAART alone (without Interleukin-2)
570509|NCT00071890|E1|Reported Event|Interleukin-2 Group|HAART and tree cycles of IL-2
570510|NCT00071812|B5|Baseline|Total|Total of all reporting groups
570511|NCT00071812|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570512|NCT00071812|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570513|NCT00071812|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570514|NCT00071812|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570515|NCT00071812|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 24-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
570516|NCT00071812|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
570517|NCT00071812|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 24-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
570518|NCT00071812|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study.
570519|NCT00071812|O5|Outcome|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
570520|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570521|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570522|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570523|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570524|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570525|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570526|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570527|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570528|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570529|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570530|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570531|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570532|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570533|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570534|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570535|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570536|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570537|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570538|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570539|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570540|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570541|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570542|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570543|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570544|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570545|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570546|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570547|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570548|NCT00071812|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570549|NCT00071812|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570550|NCT00071812|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570551|NCT00071812|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570552|NCT00071812|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 24-week double blind period and opted to continue in the 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
570553|NCT00071812|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570554|NCT00071812|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570555|NCT00071812|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570556|NCT00071812|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for RA for 24-week double-blind period of the study
570557|NCT00071799|B3|Baseline|Total|Total of all reporting groups
570558|NCT00071799|B2|Baseline|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570559|NCT00071799|B1|Baseline|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570560|NCT00071799|P2|Participant Flow|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570561|NCT00071799|P1|Participant Flow|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570562|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570563|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570564|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570565|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570566|NCT00071799|O4|Outcome|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles – 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
570567|NCT00071799|O3|Outcome|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
570568|NCT00071799|O2|Outcome|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
570569|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570570|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570571|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570572|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570573|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570574|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570575|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570576|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570577|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570578|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570579|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570580|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570581|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570582|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570583|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570584|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570585|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570586|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570587|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570588|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570589|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570590|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570591|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570592|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570593|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570594|NCT00071799|O2|Outcome|Conventional Care|Physician choice of low dose cytarabine, standard chemotherapy, or best supportive care (consisting of blood products, growth factors, antibiotics)
570595|NCT00071799|O1|Outcome|Azacitidine|Azacitidine, 75 mg/m^2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570596|NCT00071799|E4|Reported Event|Standard Chemotherapy|Induction cycle: Cytarabine infusion 100-200 mg/m2/day on days 1-7 + anthracycline on days 1, 2, 3 Consolidation cycle: Cytarabine infusion 100-200 mg/m2/day for 3-7 days + anthracycline on days 1 and 2 There are 28-70 days between cycles - 1 induction cycle and maximum of 2 consolidation cycles; best supportive care follows the final consolidation cycle.
570597|NCT00071799|E3|Reported Event|Low-dose Cytarabine|Cytarabine, 20 mg/m2/day subcutaneously on Days 1-14, with 28-42 days between cycles. Plus best supportive care.
570598|NCT00071799|E2|Reported Event|Best Supportive Care Only|Care can include transfusions, antibiotics, myeloid growth factors [G-CSF and GM CSF] for neutropenic infections until the end of the study.
570599|NCT00071799|E1|Reported Event|Azacitidine|Azacitidine, 75 mg/m2/day given by subcutaneous injection for 7 days of every 28 day cycle, plus best supportive care.
570600|NCT00071760|B1|Baseline|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570601|NCT00071760|P1|Participant Flow|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570602|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570603|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570604|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570605|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570676|NCT00071721|E2|Reported Event|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570606|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570607|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570608|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570609|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570610|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570611|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570612|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570613|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570614|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570623|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570673|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570615|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570616|NCT00071760|O2|Outcome|ART-experienced, PI-naïve FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570617|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570618|NCT00071760|O3|Outcome|PI-experienced, ART-experienced FPV/RTV Treatment Group|PI- experienced, ART-experienced, HIV-1-infected pediatric participants (received ART previously, and >1 week prior PI therapy [no more than 3 PIs before study enrollment]) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent SDVs. Cohort 1: SDV 1: 30 mg/kg fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570619|NCT00071760|O2|Outcome|PI-naïve, ART-experienced FPV/RTV Treatment Group|PI-naïve, ART experienced, HIV-1-infected pediatric participants (received ART previously, but received <1 week's treatment with a PI) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570620|NCT00071760|O1|Outcome|ART-naïve FPV/RTV Treatment Group|ART-naïve Human immunodeficiency virus (HIV)-1-infected pediatric participants (received no antiretroviral agents prior to study enrollment) were enrolled in one of two cohorts based on their age: 6 months to <2 years (Cohort 1); 4 weeks to <6 months (Cohort 2). Participants initially underwent single dose visits (SDV). Cohort 1: SDV 1: 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, followed by SDV 2: 30/6 mg/kg FPV/ritonavir (RTV) oral solution. Cohort 2: SDV 1: 45/7 mg/kg FPV/RTV. The chronic dosing regimen for Cohort 1 was 45/7 mg/kg twice a day (BID) FPV/RTV, and for Cohort 2 was 30/7 mg/kg BID to 60/10 mg/kg BID. Per the preliminary data at Week 2 in Cohort 1, additional enrolled participants received 60/7 mg/kg FPV/RTV BID; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID with no dose increase at Week 2. In Cohort 2, additional enrolled participants received 45/10 mg/kg FPV/RTV BID.
570621|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570622|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570674|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570881|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570624|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570625|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570626|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570627|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570628|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570629|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570630|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570631|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570632|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570633|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570675|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570882|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570634|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570635|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570636|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570637|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570638|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570639|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570640|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570651|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570641|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570642|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570643|NCT00071760|O1|Outcome|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570644|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570645|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570646|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570647|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570648|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570649|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570650|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570672|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570883|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570652|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570653|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570654|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570655|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570656|NCT00071760|O2|Outcome|FPV/RTV BID: 6 Months to <2 Years|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout.
570657|NCT00071760|O1|Outcome|FPV/RTV BID: 4 Weeks to <6 Months|Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570658|NCT00071760|E1|Reported Event|FPV/RTV BID|Human immunodeficiency virus (HIV)-1-infected pediatric participants were enrolled based on age in Cohort 1 (6 months to <2 years) or Cohort 2 (4 weeks to <6 months). Participants initially underwent two single dose visits (SDV): 30 milligrams per kilogram (mg/kg) fosamprenavir (FPV) oral suspension, 30/6 mg/kg FPV/ritonavir (RTV) oral solution, followed by individualized dosing (30/7 mg/kg BID to 60/10 mg/kg FPV/RTV twice a day [BID]). Per preliminary data at Week 2, the chronic dosing regimen for Cohort 1 was 45/7 mg/kg FPV/RTV BID, then changed to 45/7 mg/kg FPV/RTV BID with an increase to 60/7 mg/kg FPV/RTV BID at Week 2; later, per another analysis, all additional participants enrolled remained on 45/7 mg/kg FPV/RTV BID throughout. Per data for Cohort 1, participants in Cohort 2 underwent one SDV (45/7 mg/kg FPV/RTV), followed by individualized dosing (30/7 mg/kg to 60/10 mg/kg FPV/RTV BID). Additional enrolled participants in Cohort 2 later received 45/10 mg/kg FPV/RTV BID.
570659|NCT00071721|B3|Baseline|Total|Total of all reporting groups
570660|NCT00071721|B2|Baseline|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570661|NCT00071721|B1|Baseline|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570662|NCT00071721|P2|Participant Flow|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570663|NCT00071721|P1|Participant Flow|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570664|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570665|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570666|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570667|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570668|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570669|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570670|NCT00071721|O2|Outcome|Placebo|Placebo tablets beginning with one daily and increasing according to weight and perceived tolerability concerns for two years, followed by a 2-month washout
570671|NCT00071721|O1|Outcome|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570677|NCT00071721|E1|Reported Event|Valproate|250mg tablets beginning with one daily for one week, then two daily for one week, then titrated according to body weight and tolerability to achieve 10-12 mg/kg daily for 2 years, followed by a 2-month washout
570678|NCT00071513|B3|Baseline|Total|Total of all reporting groups
570679|NCT00071513|B2|Baseline|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
570680|NCT00071513|B1|Baseline|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
570681|NCT00071513|P2|Participant Flow|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
570682|NCT00071513|P1|Participant Flow|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTS leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
570683|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~Brief Intervention: Assessment of needs and referral to services as needed."
570684|NCT00071513|O1|Outcome|CAST-T/HSTS|"The CAST-T/HSTS condition combined the Brief Intervention and 12 school based small group sessions which taught skills to enhance personal control (to manage depression, anger, stress), self-esteem, decision making and interpersonal communications. HSTS skills groups were held in the spring of 8th grade with 4 one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents also participated in 4 sessions. HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST-T/HSTS: Skills training small group."
570685|NCT00071513|O2|Outcome|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
570710|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570711|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570712|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570713|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570714|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570884|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570686|NCT00071513|O1|Outcome|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
570687|NCT00071513|E2|Reported Event|Brief Intervention|"Brief Intervention: After each youth and parent completed baseline questionnaires the youth participated in a 1 on 1 standardized clinical follow-up with a trained clinician (blind to study condition) to review areas of concern, based on questionnaire responses including stressors at school, home, and with peers, level of support available and how to access support. The teen and clinician then planned a feedback call to parents, allowing teens to shape requests for support from parents as well as understand exactly what information would be shared with parents. Feedback call to parents reviewed concerns and made recommendations for services as needed. A similar procedure was followed after each assessment for all participants who indicated a risk of clinical depression or self-harm.~CAST/HSTS Preventive Intervention: Brief Intervention"
570688|NCT00071513|E1|Reported Event|CAST-T/HSTS|"HSTS condition combined the Brief Intervention and the HSTS protocol. HSTS introduced skills to enhance personal control (management of depression, anger and stress), self-esteem, decision making and interpersonal communications. Skills were taught in school based small groups to foster social support with outreach to teachers, peers, and parents. HSTS skills groups were held in the spring of 8th grade followed by four one-on-one booster sessions delivered to the students as 9th graders by HSTP leaders; parents participated in four educational sessions.~HSTS objectives are: 1) to increase the acquisition of coping skills competencies by teaching and practicing strategies taught; 2) to increase social support resources by building a supportive network; 3) to increase the youth's engagement in positive social activities; and 4) to motivate parents to increase their support via parent educational sessions.~CAST/HSTS Preventive Intervention: Brief Intervention"
570689|NCT00071487|B5|Baseline|Total|Total of all reporting groups
570690|NCT00071487|B4|Baseline|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570691|NCT00071487|B3|Baseline|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570692|NCT00071487|B2|Baseline|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570693|NCT00071487|B1|Baseline|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570694|NCT00071487|P4|Participant Flow|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24 week-open label extension period of the study included patients who completed the 52-week double-blind period and opted to continue in the 24-week open-label period of the study and included patients who were originally randomized to the belimumab 10 mg/kg group in the double-blind period, patients who switched to belimumab 10 mg/kg at the investigator's discretion, and former placebo patients.
570695|NCT00071487|P3|Participant Flow|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
570696|NCT00071487|P2|Participant Flow|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study. The 24-week open-label extension period of the study included patients who completed the 52-week double-blind period and opted to continue to receive the same dose in the 24-week open-label extension period of the study.
570697|NCT00071487|P1|Participant Flow|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570698|NCT00071487|O5|Outcome|Open-Label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to belimumab 10 mg/kg at the investigator's discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
570699|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570700|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570701|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570702|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570703|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570704|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570705|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570706|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570707|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570708|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570709|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570826|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Standard dose imatinib A
570715|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570716|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570717|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570718|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570719|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570720|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570721|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570722|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570723|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570724|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570725|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570726|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570727|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570728|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570729|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570730|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570731|NCT00071487|O4|Outcome|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570732|NCT00071487|O3|Outcome|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570733|NCT00071487|O2|Outcome|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570734|NCT00071487|O1|Outcome|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study.
570735|NCT00071487|E5|Reported Event|Open-label Extension Period: All Active|Includes all patients who completed the 52-week double-blind period and opted to continue in a 24-week open-label extension period. Belimumab patients received the same dose or were switched to 10 mg/kg at investigator discretion and former placebo patients received belimumab 10 mg/kg. AE onset may be during the extension phase or continuing from the double-blind period.
570736|NCT00071487|E4|Reported Event|Belimumab 10 mg/kg Plus SOC|Belimumab 10 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
570737|NCT00071487|E3|Reported Event|Belimumab 4 mg/kg Plus SOC|Belimumab 4 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
570738|NCT00071487|E2|Reported Event|Belimumab 1 mg/kg Plus SOC|Belimumab 1 mg/kg IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
570739|NCT00071487|E1|Reported Event|Placebo Plus SOC|Placebo IV plus standard therapy (SOC) for SLE for 52-week double-blind period of the study
570740|NCT00071396|B1|Baseline|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
570741|NCT00071396|P1|Participant Flow|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
570742|NCT00071396|O1|Outcome|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
570743|NCT00071396|E1|Reported Event|Campath-1H + Rituximab|"Campath 15 mg/day continuous intravenous (IV) infusion for 6 days, then twice a week for 3 weeks as 30 mg injection under skin to complete 4 week treatment course.~Rituximab 375 mg/m^2 IV infusion day 1, then 500 mg/m^2 on days 8, 15 + 22."
570744|NCT00071110|B3|Baseline|Total|Total of all reporting groups
570745|NCT00071110|B2|Baseline|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570746|NCT00071110|B1|Baseline|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570747|NCT00071110|P2|Participant Flow|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570748|NCT00071110|P1|Participant Flow|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570749|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570750|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570751|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570877|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570752|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570753|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570754|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570755|NCT00071110|O2|Outcome|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570756|NCT00071110|O1|Outcome|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570757|NCT00071110|E2|Reported Event|Sham Acupuncture (SA)|Needles placed laterally on the scalp, not corresponding to any traditional meridians. No electrical stimulation delivered.
570758|NCT00071110|E1|Reported Event|Electroacupuncture (EA)|Needles placed at traditional meridian locations, GV-20 (on the crown of the head) and yin tang (in the midline of the forehead roughly at the glabella) and treated with electrical stimulation.
570759|NCT00071058|B1|Baseline|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
570760|NCT00071058|P1|Participant Flow|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
570761|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m^2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
570762|NCT00071058|O1|Outcome|Surgery Plus Chemotherapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
570763|NCT00071058|E1|Reported Event|Surgery Plus Chemothrapy|"Surgical resection can be performed at the time of study entry, when patients have a mixed response, or if their tumors respond to chemotherapy.~Surgical resection will be followed by chemotherapy with 2 grams oral dose daily of mitotane on cycle 1, day 1, 6 mg/m^2 continuous intravenous infusion doxorubicin over 96 hours days 1-4, 0.18 mg/m2 continuous intravenous infusion vincristine over 96 hours days 1-4, and 36 mg/m^2 continuous intravenous infusion etoposide over 96 hours days 1-4, and 150 mg tariquidar through central venous catheter over 30 minutes on days 1 and 3."
570764|NCT00071032|B3|Baseline|Total|Total of all reporting groups
570765|NCT00071032|B2|Baseline|Restrictive Strategy|"Symptomatic transfusion strategy, a more conservative strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia.~Restrictive (Symptomatic) Transfusion Strategy: Transfusion is withheld until the patient develops symptoms from anemia (i.e., chest pain or ECG changes thought to be ischemic, congestive heart failure, unexplained tachycardia or hypotension unresponsive to fluids) or until the hemoglobin level falls below 8 g/dL. Transfusion is permitted, but is not mandatory, if the hemoglobin level falls below 8 g/dL."
570766|NCT00071032|B1|Baseline|Liberal (10 g/dL) Transfusion Strategy|"Transfusion strategy that maintains postoperative Hgb levels above 10 g/dL.~Liberal (10 g/dL) Transfusion Strategy: Maintains postoperative Hgb levels above 10 g/dL. This threshold strategy uses enough red blood cell units to maintain Hgb levels at or above 10 g/dL through hospital discharge or up to 30 days after randomization."
570767|NCT00071032|P2|Participant Flow|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
570768|NCT00071032|P1|Participant Flow|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
570769|NCT00071032|O2|Outcome|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
570770|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
570771|NCT00071032|O2|Outcome|Restrictive Strategy|Blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
570772|NCT00071032|O1|Outcome|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains postoperative Hgb levels >= 10 g/dL
570773|NCT00071032|E2|Reported Event|Restrictive Strategy|Symptomatic transfusion strategy, in which blood transfusion is withheld until the patient develops symptoms of anemia or at physician discretion of the hemoglobin level falls below 8 g/dL
570774|NCT00071032|E1|Reported Event|Liberal (10 g/dL) Transfusion Strategy|Transfusion strategy that maintains post randomization Hgb levels >= 10 g/dL
570878|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570775|NCT00071006|B1|Baseline|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570776|NCT00071006|P1|Participant Flow|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570777|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570778|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570779|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570780|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570781|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570782|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570783|NCT00071006|O1|Outcome|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570784|NCT00071006|E1|Reported Event|Axitinib|Axitinib (AG-013736) tablet administered orally at a dose of 5 milligram (mg) twice daily (BID) continuously. Treatment was administered continuously until progression, relapse, failure, or disease transformation or toxicity occurred.
570785|NCT00070941|B4|Baseline|Total|Total of all reporting groups
570786|NCT00070941|B3|Baseline|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
570787|NCT00070941|B2|Baseline|Escitalopram|oral Escitalopram 10mg or 20m
570788|NCT00070941|B1|Baseline|SAM-e|oral SAM-e, 1200mg or 2400 mg
570789|NCT00070941|P3|Participant Flow|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
570790|NCT00070941|P2|Participant Flow|Escitalopram|oral Escitalopram 10mg or 20m
570791|NCT00070941|P1|Participant Flow|SAM-e|SAM-e, 1200mg or 2400 mg
570792|NCT00070941|O3|Outcome|Placebo Comparator|oral placebo Escitalopram and placebo SAM-e
570793|NCT00070941|O2|Outcome|Escitalopram|oral Escitalopram 10mg or 20m
570794|NCT00070941|O1|Outcome|SAM-e|SAM-e, 1200mg or 2400 mg
570795|NCT00070941|E3|Reported Event|Placebo|Group C/Twenty patients receiving oral placebo Escitalopram an
570796|NCT00070941|E2|Reported Event|Oral Escitalopram|Group B/Forty patients receiving oral Escitalopram 10mg or 20m
570797|NCT00070941|E1|Reported Event|SAM-e|Group A/Forty patients receiving oral SAM-e, 1200mg or 2400 mg
570798|NCT00070499|B5|Baseline|Total|Total of all reporting groups
570799|NCT00070499|B4|Baseline|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
570800|NCT00070499|B3|Baseline|Dasatinib|
570801|NCT00070499|B2|Baseline|High Dose Imatinib|
570802|NCT00070499|B1|Baseline|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
570803|NCT00070499|P4|Participant Flow|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib. Standard dose imatinib was 400 mg daily.
570804|NCT00070499|P3|Participant Flow|Dasatinib|Dasatinib dose was 100 mg daily
570805|NCT00070499|P2|Participant Flow|High Dose Imatinib|High dose imatinib was 800 mg daily.
570806|NCT00070499|P1|Participant Flow|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib. Standard dose imatinib was 400 mg daily.
570807|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib. patients received 400 mg imatinib daily
570808|NCT00070499|O3|Outcome|Dasatinib|Patients received 100 mg dasatinib daily
570809|NCT00070499|O2|Outcome|High Dose Imatinib|Patients received 800 mg imatinib daily
570810|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib. patients received 400 mg imatinib daily
570811|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
570812|NCT00070499|O3|Outcome|Dasatinib|
570813|NCT00070499|O2|Outcome|High Dose Imatinib|
570814|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
570815|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
570816|NCT00070499|O3|Outcome|Dasatinib|
570817|NCT00070499|O2|Outcome|High Dose Imatinib|
570818|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
570819|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib and dasatinib
570820|NCT00070499|O3|Outcome|Dasatinib|
570821|NCT00070499|O2|Outcome|High Dose Imatinib|
570822|NCT00070499|O1|Outcome|Standard Dose Imatinib A|Randomization between occurred between standard dose imatinib A and high dose imatinib
570823|NCT00070499|O4|Outcome|Standard Dose Imatinib B|Standard dose imatinib B
570824|NCT00070499|O3|Outcome|Dasatinib|Dasatinib
570825|NCT00070499|O2|Outcome|High Dose Imatinib|High dose imatinib
570827|NCT00070499|E4|Reported Event|Standard Dose Imatinib B|Randomization occurred between Standard dose imatinib B and dasatinib/ patients received 400 mg imatinib daily
570828|NCT00070499|E3|Reported Event|Dasatinib|Patients received 100 mg dasatinib daily
570829|NCT00070499|E2|Reported Event|High Dose Imatinib|Patients received 800 mg imatinib daily
570830|NCT00070499|E1|Reported Event|Standard Dose Imatinib A|Randomization occurred between standard dose imatinib A and high dose imatinib/ patients received 400 mg imatinib daily
570831|NCT00070291|B1|Baseline|Cyclosporine|
570832|NCT00070291|P1|Participant Flow|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
570833|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
570834|NCT00070291|O1|Outcome|Cyclosporine|"Cyclosporine doses will be based on actual body weight unless actual body weight is > 15 kg higher than the ideal body weight. Cyclosporine dose will be adjusted to maintain a trough whole blood level of 250-450 ng/mL during the high dose period (weeks 1 -6) and 150-250 ng/mL during the maintenance period (weeks 7-36) in the absence of renal toxicity.~High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment."
570835|NCT00070291|E1|Reported Event|Cyclosporine|High dose cyclosporine weeks 1-6, then maintenance dose cyclosporine weeks 7-36. If CR, PR, or SD at week 36 evaluation, treatment is complete. If progression occurs during weeks 7-36, patients will re-register to Step 2 at time of PD and begin high dose therapy (weeks 1-6), followed by maintenance therapy (weeks 7-36). At second progression patients will end protocol treatment.
570836|NCT00070109|B6|Baseline|Total|Total of all reporting groups
570837|NCT00070109|B5|Baseline|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570838|NCT00070109|B4|Baseline|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570839|NCT00070109|B3|Baseline|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570840|NCT00070109|B2|Baseline|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570841|NCT00070109|B1|Baseline|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
570842|NCT00070109|P5|Participant Flow|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570843|NCT00070109|P4|Participant Flow|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570844|NCT00070109|P3|Participant Flow|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570845|NCT00070109|P2|Participant Flow|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
570846|NCT00070109|P1|Participant Flow|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. A cohort of 6 patients will be enrolled at the 1.3 mg/m2 dose level.~trabectedin: Given IV~pharmacological study: Correlative studies"
570847|NCT00070109|O2|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity. Six toxicity-evaluable patients are assigned this treatment.~trabectedin: Given IV"
570848|NCT00070109|O1|Outcome|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
570879|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570880|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570849|NCT00070109|O4|Outcome|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570850|NCT00070109|O3|Outcome|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570851|NCT00070109|O2|Outcome|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570852|NCT00070109|O1|Outcome|Trabectedin 1.5 mg/m2 to Assess Feasibility|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570853|NCT00070109|E5|Reported Event|Trabectedin 1.5 mg/m2 - Assess Efficacy in Nonrhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570854|NCT00070109|E4|Reported Event|Trabectedin at 1.5 mg/m2 - Assess Efficacy in Rhabdomyosarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570855|NCT00070109|E3|Reported Event|Trabectedin at 1.5 mg/m2 to Assess Efficacy in Ewing Sarcoma|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570856|NCT00070109|E2|Reported Event|Trabectedin 1.5 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV"
570857|NCT00070109|E1|Reported Event|Trabectedin 1.3 mg/m2 to Assess Feasibility in All Patients|"Patients receive trabectedin over 3 hours on day 1. Treatment repeats every 21 days for up to 26 courses in the absence of disease progression or unacceptable toxicity.~trabectedin: Given IV~pharmacological study: Correlative studies"
570858|NCT00070018|B1|Baseline|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
570859|NCT00070018|P1|Participant Flow|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
570860|NCT00070018|O1|Outcome|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
570861|NCT00070018|E1|Reported Event|CHOP + RT + Zevalin|Patients first receive 3 cycles (21 days each) of CHOP, consisting of: cyclophosphamide 750 mg/m^2 on day 1, doxorubicin 50 mg/m^2 on day 1, vincristine 1.4 mg/m^2 on day 1, and prednisone 100 mg on days 1-5. Patients receive 4000-5000 cGy of radiation therapy in 25 fractions, starting 3 weeks after completion of CHOP. 3-6 weeks after completing RT, patients receive Zevalin, which consists of: rituximab 250 mg/m^2 on days 1 and 7, 8 or 9; In-111 ibritumomab tiuxetan 5 mCi within 4 hours after rituximab on day 1; and Y-90 ibritumomab tiuxetan 0.4 mCi/kg within 4 hours after rituximab on day 7, 8 or 9.
570862|NCT00069953|B1|Baseline|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
570863|NCT00069953|P1|Participant Flow|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
570864|NCT00069953|O1|Outcome|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
570865|NCT00069953|E1|Reported Event|ChemoRT and Selective Surgery|Induction therapy of fluorouracil, cisplatin, paclitaxel, and pegfilgrastim OR filgrastim, then chemoradiotherapy of concurrent cisplatin and fluorouracil with external beam radiotherapy (RT), followed by selective salvage therapy.
570866|NCT00069823|B3|Baseline|Total|Total of all reporting groups
570867|NCT00069823|B2|Baseline|Esomeprazole|40 mg of esomeprazole twice daily
570868|NCT00069823|B1|Baseline|Placebo|40 mg of placebo twice daily
570869|NCT00069823|P2|Participant Flow|Esomeprazole|40 mg of esomeprazole twice daily
570870|NCT00069823|P1|Participant Flow|Placebo|40 mg of placebo twice daily
570871|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570872|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570873|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570874|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570875|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570876|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570885|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570886|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570887|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570888|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570889|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570890|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570891|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570892|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570893|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570894|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570895|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570896|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570897|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570898|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570899|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570900|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570901|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570902|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570903|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570904|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570905|NCT00069823|O2|Outcome|Esomeprazole|40 mg of esomeprazole twice daily
570906|NCT00069823|O1|Outcome|Placebo|40 mg of placebo twice daily
570907|NCT00069823|E2|Reported Event|Esomeprazole|40 mg of esomeprazole twice daily
570908|NCT00069823|E1|Reported Event|Placebo|40 mg of placebo twice daily
570909|NCT00069784|B3|Baseline|Total|Total of all reporting groups
570910|NCT00069784|B2|Baseline|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570911|NCT00069784|B1|Baseline|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570912|NCT00069784|P2|Participant Flow|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570913|NCT00069784|P1|Participant Flow|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570914|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570915|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570916|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570917|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570918|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570919|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570920|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570921|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570922|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570923|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570924|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570925|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570926|NCT00069784|O2|Outcome|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570927|NCT00069784|O1|Outcome|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570928|NCT00069784|E2|Reported Event|Standard Care|Standard care with or without omega-3 polyunsaturated fatty acids
570929|NCT00069784|E1|Reported Event|Insulin Glargine|Treatment with Insulin Glargine with or without omega-3 polyunsaturated fatty acids
570930|NCT00069641|B4|Baseline|Total|Total of all reporting groups
570931|NCT00069641|B3|Baseline|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570932|NCT00069641|B2|Baseline|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570933|NCT00069641|B1|Baseline|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570934|NCT00069641|P3|Participant Flow|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570935|NCT00069641|P2|Participant Flow|Idursulfase Every Other Week (EOW) (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570936|NCT00069641|P1|Participant Flow|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 milligram per kilogram (mg/kg) administered once-weekly by intravenous infusion for one year (52 infusions).
570937|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570938|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570939|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570940|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
571845|NCT00063635|E2|Reported Event|Vitamin E|Vitamin E, 400 IU, twice daily
570941|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570942|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570943|NCT00069641|O2|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570944|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570945|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570946|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570947|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570948|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570949|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570950|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570951|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570952|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570953|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570954|NCT00069641|O3|Outcome|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570955|NCT00069641|O2|Outcome|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570956|NCT00069641|O1|Outcome|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570957|NCT00069641|E3|Reported Event|Placebo|Placebo matching to idursulfase administered once-weekly by intravenous infusion for one year (52 infusions).
570958|NCT00069641|E2|Reported Event|Idursulfase EOW (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered every other week by intravenous infusion for one year (26 infusions) along with placebo matching to idursulfase every other week (alternating with idursulfase) by intravenous infusion for one year (26 infusions).
570959|NCT00069641|E1|Reported Event|Idursulfase Weekly (0.5 mg/kg)|Idursulfase 0.5 mg/kg administered once-weekly by intravenous infusion for one year (52 infusions).
570960|NCT00069329|B1|Baseline|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570961|NCT00069329|P1|Participant Flow|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570962|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570963|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570964|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570965|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570966|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570967|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570968|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570969|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570970|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570971|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570972|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570973|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570974|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570975|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570976|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570977|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570978|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570979|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570980|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570981|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570982|NCT00069329|O1|Outcome|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570983|NCT00069329|E1|Reported Event|NOMID|Patients who met the criteria for NOMID and treated with escalating doses of anakinra 1-5 mg/kg/day to achieve laboratory and organ inflammation remission.
570984|NCT00069277|B1|Baseline|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
570985|NCT00069277|P1|Participant Flow|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
570986|NCT00069277|O1|Outcome|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
570987|NCT00069277|E1|Reported Event|E7389 Dose-Escalating|E7389 dose-escalation starting at 0.25 mg/m^2 intravenous on Day 1 of a 21 day cycle. Dose escalations scheme used a two part design and proceeded based on dose-limiting toxicity and maximum tolerated dose.
570988|NCT00069264|B1|Baseline|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
570989|NCT00069264|P1|Participant Flow|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
570990|NCT00069264|O1|Outcome|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
570991|NCT00069264|E1|Reported Event|E7389|E7389 Dose-escalation starting at 0.25 mg/m^2 intravenous on Days 1, 8, and 15 of a 28 day cycle.
570992|NCT00069238|B1|Baseline|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
570993|NCT00069238|P3|Participant Flow|Alemtuzumab 90 mg|Alemtuzumab (Campath) 90mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
570994|NCT00069238|P2|Participant Flow|Alemtuzumab 60 mg|Alemtuzumab (Campath) 60mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
570995|NCT00069238|P1|Participant Flow|Alemtuzumab 30 mg|Alemtuzumab (Campath) 30mg intravenous (IV) on day 1 of therapy, followed by etoposide (50mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), prednisone (60mg/m(2) day by mouth (PO) day 0-5), vincristine (0.4mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), cyclophosphamide (750mg/m(2) day intravenous day 5), doxorubicin (10mg/m(2) day continuous intravenous (CIV) day 1-4 (96 hours)), (EPOCH) days 1-5 every 3 weeks for up to 6 cycles.
570996|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
570997|NCT00069238|O1|Outcome|All Participants|All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.
570998|NCT00069238|E1|Reported Event|All Participants|"All participants who received at least one dose of Alemtuzumab (Campath) 30mg, 60mg, or 90mg on day 1 of therapy followed by etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin (EPOCH) chemotherapy intravenously every 3 weeks for up to 6 cycles.~The adverse events are not reported per dose level because we normally look at all adverse events together irrespective of the dose level."
570999|NCT00069160|B3|Baseline|Total|Total of all reporting groups
571000|NCT00069160|B2|Baseline|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
571001|NCT00069160|B1|Baseline|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
571002|NCT00069160|P2|Participant Flow|Pts Who Received Docetaxel on Days 1, 8, & Tariquidar Day 1,22|Patients receive docetaxel intravenous (IV) over 1 hour on days 1 and 8 and tariquidar intravenous (IV) over 30 minutes on days 1 and 22.From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
571003|NCT00069160|P1|Participant Flow|Pts Who Received Docetaxel on Day 1, 8, & Tariquidar Day 8,22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg tariquidar dose.
571004|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571005|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571006|NCT00069160|O1|Outcome|All Patients Who Received Docetaxel and Tariquidar|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571007|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
571008|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
571009|NCT00069160|O2|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571010|NCT00069160|O1|Outcome|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571011|NCT00069160|O2|Outcome|With Tariquidar|40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on either day 1 or 8 and then again on day 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose of tariquidar.
571012|NCT00069160|O1|Outcome|Docetaxel Alone|40 mg/m^2 docetaxel over 1 hour on days 1 and 8.
571013|NCT00069160|E2|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Days 1, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571014|NCT00069160|E1|Reported Event|Patients on Docetaxel on Days 1, 8 & Tariquidar on Day 8, 22|Patients receive 40 mg/m^2 docetaxel intravenous (IV) over 1 hour on days 1 and 8 and 150 mg tariquidar intravenous (IV) over 30 minutes on days 8 and 22. From cycle 2 and onward 75 mg/m^2 docetaxel was administered every 21 days in combination with a single 150 mg dose.
571015|NCT00069121|B3|Baseline|Total|Total of all reporting groups
571016|NCT00069121|B2|Baseline|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571017|NCT00069121|B1|Baseline|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571018|NCT00069121|P2|Participant Flow|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571019|NCT00069121|P1|Participant Flow|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571020|NCT00069121|O3|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571021|NCT00069121|O2|Outcome|5-FU/LV ROSWELL PARK|Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)
571022|NCT00069121|O1|Outcome|5-FU/LV MAYO CLINIC|Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks)
571023|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571024|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571025|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571026|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571027|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571028|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571029|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571030|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571031|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571032|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571033|NCT00069121|O2|Outcome|XELOX|Capecitabine administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks)
571034|NCT00069121|O1|Outcome|5-FU/LV|"Given by one of two regimens.~Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or~Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks)"
571035|NCT00069121|E3|Reported Event|XELOX|Capecitabine in Combination with Intravenous Oxaliplatin (Q3W)
571036|NCT00069121|E2|Reported Event|5-FU/LV ROSWELL PARK|5-fluorouracil/leucovorin
571037|NCT00069121|E1|Reported Event|5-FU/LV MAYO CLINIC|5-fluorouracil/leucovorin
571038|NCT00069108|B3|Baseline|Total|Total of all reporting groups
571145|NCT00068770|B1|Baseline|p450 ( +EIASD)|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
571039|NCT00069108|B2|Baseline|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571040|NCT00069108|B1|Baseline|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 IV infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571041|NCT00069108|P2|Participant Flow|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571042|NCT00069108|P1|Participant Flow|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571043|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571044|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571045|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571046|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571047|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571048|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571049|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571146|NCT00068770|P2|Participant Flow|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
571147|NCT00068770|P1|Participant Flow|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
571050|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571051|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571052|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571053|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571054|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571055|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571056|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571057|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571058|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571059|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571060|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571175|NCT00068419|O1|Outcome|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
571061|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571062|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571063|NCT00069108|O2|Outcome|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571064|NCT00069108|O1|Outcome|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571065|NCT00069108|E2|Reported Event|FOLFOX-4|Participants received FOLFOX-4 (combination of oxaliplatin, leucovorin [LV] and 5-fluorouracil [5-FU] combination). Oxaliplatin was administered as an 85 mg/m^2 IV infusion over 2 hours (on Day 1 only); with LV infusion as 200mg/m^2 over 2 hours followed by 5-FU, given as 400mg/m^2 bolus injection over 2-4 minutes, and then as a 600 mg/m^2 continuous infusion over 22 hours. On Day 2, Leucovorin 200 mg/m^2 (alone), followed by 5-FU 400 mg/m^2 bolus injection over 2-4 minutes, and 5-FU 600 mg/m^2 continuous infusion was repeated over 22 hours. It was (2-week cycles comprising 48 hours of infusion and 12 days of rest) for up to 12 cycles (24- weeks).
571066|NCT00069108|E1|Reported Event|XELOX|Participants received XELOX (oxaliplatin and capecitabine). Oxaliplatin was administered 130 mg/m^2 intravenous (IV) infusion over 2 hours (every 3 weeks [Day 1]) before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), with first dose the evening of Day 1 and last dose the morning of Day 15, given as intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) for up to 8 cycles (24-weeks).
571067|NCT00069095|B7|Baseline|Total|Total of all reporting groups
571068|NCT00069095|B6|Baseline|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571069|NCT00069095|B5|Baseline|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571070|NCT00069095|B4|Baseline|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571134|NCT00068822|P1|Participant Flow|Vertebroplasty, Then Control|Participants randomized to receive percutaneous vertebroplasty first (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture). At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative Control procedure, Sham Vertebroplasty (partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.)
571071|NCT00069095|B3|Baseline|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571072|NCT00069095|B2|Baseline|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571073|NCT00069095|B1|Baseline|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571074|NCT00069095|P6|Participant Flow|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571075|NCT00069095|P5|Participant Flow|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571076|NCT00069095|P4|Participant Flow|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571077|NCT00069095|P3|Participant Flow|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571104|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571135|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
571078|NCT00069095|P2|Participant Flow|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571079|NCT00069095|P1|Participant Flow|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571080|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571081|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571082|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571083|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571084|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571085|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571086|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571136|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
571087|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571088|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571089|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571090|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571091|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571092|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571093|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571094|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571105|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571137|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
571095|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571096|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571097|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571098|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571099|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571100|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571101|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571102|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571103|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571138|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
571139|NCT00068822|O2|Outcome|Control Group|Participants will receive partial vertebroplasty without PMMA
571106|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571107|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571108|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571109|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571110|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571111|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571112|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571113|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571114|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571140|NCT00068822|O1|Outcome|Vertebroplasty|Participants will receive percutaneous vertebroplasty
571141|NCT00068822|E2|Reported Event|Control Group|Participants will receive partial vertebroplasty without PMMA
571142|NCT00068822|E1|Reported Event|Vertebroplasty|Participants will receive percutaneous vertebroplasty
571143|NCT00068770|B3|Baseline|Total|Total of all reporting groups
571115|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571116|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571117|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571118|NCT00069095|O2|Outcome|FOLFOX-4+BV/XELOX+BV|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571119|NCT00069095|O1|Outcome|FOLFOX-4+P/XELOX+P|"Participants from the 2x2 factorial part of the study including the following groups -~Folfox-4+P: Participants received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks)."
571120|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571121|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571122|NCT00069095|O2|Outcome|XELOX/XELOX+P/XELOX+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Xelox: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin (given on day 1).~Xelox+P: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and placebo (P) control for bevacizumab (both given on day 1 every 3 weeks).~Xelox+BV: Capecitabine was administered as an oral twice-daily outpatient intermittent treatment (3-week cycles consisting of 2 weeks of treatment followed by 1 week without treatment) combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 3 weeks)."
571133|NCT00068822|P2|Participant Flow|Control, Then Vertebroplasty|Participants randomized to receive Control procedure, Sham Vertebroplasty first (Partial vertebroplasty without PMMA in which participants were given verbal and physical cues such as pressure on the back, following local anesthesia with lidocaine and bupivacaine, but the needle was not placed.) At Month 1 or Month 3 if participants did not get enough pain relief from the procedure, they could opt to crossover to the alternative percutaneous vertebroplasty (placement of polymethylmethacrylate [PMMA] into vertebral compression fracture).
571248|NCT00066963|E2|Reported Event|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
571123|NCT00069095|O1|Outcome|FOLFOX-4/FOLFOX-4+P/FOLFOX-4+BV|"Participants from the initial 2-arm part and the 2x2 factorial part of the study including the following groups -~Folfox-4: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin (given on day 1).~Folfox-4+P: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and placebo control for bevacizumab (both given on day 1 every 2 weeks).~Folfox-4+BV: Participants who received 2-week cycles of infused leucovorin, bolus injection fluorouracil and continuous infusion fluorouracil (given on days 1 and 2), combined with intravenous oxaliplatin and intravenous bevacizumab (both given on day 1 every 2 weeks)."
571124|NCT00069095|E6|Reported Event|Folfox-4+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 5 mg/kg over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571125|NCT00069095|E5|Reported Event|Xelox+BV|Participants in the 2x2 factorial part of the study received intravenous infusion of bevacizumab 7.5 mg/kg over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571126|NCT00069095|E4|Reported Event|Folfox-4+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for BV (volume equivalent to 5 mg/kg BV) over 30 to 90 minutes followed by oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571127|NCT00069095|E3|Reported Event|Xelox+P|Participants in the 2x2 factorial part of the study received intravenous infusion of placebo control for bevacizumab (BV) [volume equivalent to 7.5 mg/kg BV] over 30 to 90 minutes followed by oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks in combination with capecitabine, administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571128|NCT00069095|E2|Reported Event|Folfox-4|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 85 mg/m^2 on Day 1 of every 2-week cycle; concomitantly with leucovorin 200 mg/m^2 iv for 2 hours followed by fluorouracil 400 mg/m^2 bolus injection over 2 to 4 min followed by 600 mg/m^2 continuous infusion over 22 h on Days 1 and 2 of every 2-week cycle. Participants received up to 24 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571129|NCT00069095|E1|Reported Event|Xelox|Participants in the 2-arm part of the study received intravenous infusion of oxaliplatin 130 mg/m^2 over 2 hours on Day 1 of every 3 weeks before the first dose of capecitabine. Capecitabine was administered orally within 30 minutes after the end of a meal (breakfast and dinner) at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2), for the first 2 weeks of every 3-week cycle. Participants received up to 16 cycles of treatment during the primary study treatment phase (48 weeks). Participants who completed the 48-week primary study treatment phase without progressive disease were eligible to enter the post-study treatment phase at the discretion of the investigator and the sponsor. Participants who entered this phase were to continue treatment on the same regimen to which they were initially randomized until either progression of disease was documented, unacceptable toxicity occurred, or the participant withdrew consent.
571130|NCT00068822|B3|Baseline|Total|Total of all reporting groups
571131|NCT00068822|B2|Baseline|Control Group|Participants will receive partial vertebroplasty without PMMA
571132|NCT00068822|B1|Baseline|Vertebroplasty|Participants will receive percutaneous vertebroplasty
571144|NCT00068770|B2|Baseline|nonp450 (-EIASD)|not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.
571249|NCT00066963|E1|Reported Event|No Intervention: Counseling Only|Counseling Only (0FV)
571250|NCT00066807|B3|Baseline|Total|Total of all reporting groups
571148|NCT00068770|O2|Outcome|nonp450 (-EIASD)|"not on p450 inhibitor (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate.~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
571149|NCT00068770|O1|Outcome|p450 ( +EIASD)|"on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)~latest survial data was obtained on May 30, 2006. 31/35 pts had died (89%) 21 in the +EIASD group and 10 in -EIASD group"
571150|NCT00068770|O2|Outcome|p450|"on p450 inhibitor~celecoxib :~radiation therapy :"
571151|NCT00068770|O1|Outcome|nonp450|"not on p450 inhibitor~celecoxib :~radiation therapy :"
571152|NCT00068770|E2|Reported Event|Non P450 ARM|NOT on p450 inhibitor *non P450 ARM (Patients either NOT taking anti-seizure drugs or ones that are known to not significantly influence the hepatic drug-metabolizing enzymes - including gabapentin, lamotrigine, valproic acid, levetiracetam, tiagabine,topiramate, zonisamide and filbamate, Keppra.
571153|NCT00068770|E1|Reported Event|P450 ARM|on p450 inhibitor (Patients taking anttiseizure drugs that are known to induce the hepatic drug-metabolizing enzymes - including phenytoin, carbamazepine, phenobarbital, primidone and oxcarbazepine)
571154|NCT00068588|B4|Baseline|Total|Total of all reporting groups
571155|NCT00068588|B3|Baseline|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571156|NCT00068588|B2|Baseline|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571157|NCT00068588|B1|Baseline|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571158|NCT00068588|P3|Participant Flow|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571159|NCT00068588|P2|Participant Flow|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571160|NCT00068588|P1|Participant Flow|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571161|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571162|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571163|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571164|NCT00068588|O3|Outcome|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571165|NCT00068588|O2|Outcome|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571166|NCT00068588|O1|Outcome|Arm 1|Capecitabine 800 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571167|NCT00068588|E2|Reported Event|Arm 3|Capecitabine 1250 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571168|NCT00068588|E1|Reported Event|Arm 2|Capecitabine 1000 mg/m2 BID for 14 days on days 2-15 of each 21 day cycle +GTI-2040 civ infusion 185 mg/m2/day on days 1-15 of cycle 1 and days 1-14 of each subsequent cycle,
571169|NCT00068575|B1|Baseline|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
571170|NCT00068575|P1|Participant Flow|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
571171|NCT00068575|O1|Outcome|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
571172|NCT00068575|E1|Reported Event|Postoperative Chemoradiation Regimen|Postoperative Cisplatin 30 mg/m^2 intravenous (IV) weekly for 6 doses, Interferon Alfa-2b 3 million units subcutaneous (SQ) on Monday, Wednesday and Friday days 1-19 and 29-45 for 17 total doses, and 5-fluorouracil (5-FU) 175 mg/m2/day by continuous intravenous infusion days 1-19 and 29-45 with concurrent Radiation Treatment.
571173|NCT00068419|B1|Baseline|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
571174|NCT00068419|P1|Participant Flow|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
571251|NCT00066807|B2|Baseline|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571176|NCT00068419|E1|Reported Event|Treatment (Enzyme Inhibitor Therapy, Anti-estrogen Therapy)|Patients receive oral sulindac and oral tamoxifen citrate twice daily for up to 12 months (four 3-month courses) in the absence of disease progression or unacceptable toxicity. Patients who achieve a complete response (CR) receive 1 additional month of treatment beyond documentation of CR.
571177|NCT00068393|B1|Baseline|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571178|NCT00068393|P1|Participant Flow|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571179|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571180|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571181|NCT00068393|O1|Outcome|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571182|NCT00068393|E1|Reported Event|Doxorubicin/Gemcitabine|"Doxorubicin was given at 50 mg/m² by IV slow push, followed by gemcitabine 1500 mg/m² IV infusion over 30 minutes on day 1. Patients will receive G-CSF at a subcutaneous dose of 5mcg/kg/day on days 2 or 3 to 10 or neulasta at a dose of 6mg on day 2. Growth factor must be administered as close as possible to 24 hours after the completion of chemotherapy. It is recommended that neulasta be administered only on day 2 due to its prolonged half-life. Cycles were repeated every 2 weeks.~Only eligible and treated patients are included in the analysis."
571183|NCT00068380|B1|Baseline|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
571184|NCT00068380|P1|Participant Flow|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
571185|NCT00068380|O1|Outcome|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
571186|NCT00068380|E1|Reported Event|Treatment (Imatinib Mesylate)|"Patients receive 400 mg oral imatinib mesylate twice daily on days 1-28. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~imatinib mesylate: Given orally~laboratory biomarker analysis: Correlative studies"
571187|NCT00068237|B1|Baseline|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
571188|NCT00068237|P1|Participant Flow|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
571189|NCT00068237|O1|Outcome|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
571190|NCT00068237|E1|Reported Event|Surgery and Salivary Gland Transfer and Radiation|Patients undergo surgery for the primary and neck nodes and submandibular salivary gland transfer on Day 1 followed by post-operative radiation therapy within 4-6 weeks of surgery. Radiation therapy dose can range from 54-70 Gy over 5.5-7 weeks, at 2.0 Gy/fraction.
571191|NCT00068107|B1|Baseline|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571192|NCT00068107|P1|Participant Flow|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
571193|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571846|NCT00063635|E1|Reported Event|Metformin|Metformin, 500 mg, twice daily
571194|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month. Patients will receive a dose of 0.2 mg/kg of body weight every week.
571195|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571196|NCT00068107|O2|Outcome|All Participants at Last Observation|
571197|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571198|NCT00068107|O2|Outcome|All Participants at Last Observation|
571199|NCT00068107|O1|Outcome|All Participants at Baseline|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571200|NCT00068107|O1|Outcome|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571201|NCT00068107|E1|Reported Event|All Participants|All participants were followed on a prior protocol and found to have a mean slope on Replagal (agalsidase alfa) infused every 2 weeks of -0.66 +- 0.24 ml/min/month.
571202|NCT00067808|B4|Baseline|Total|Total of all reporting groups
571203|NCT00067808|B3|Baseline|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
571204|NCT00067808|B2|Baseline|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
571205|NCT00067808|B1|Baseline|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
571206|NCT00067808|P3|Participant Flow|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
571207|NCT00067808|P2|Participant Flow|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
571208|NCT00067808|P1|Participant Flow|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
571209|NCT00067808|O3|Outcome|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
571210|NCT00067808|O2|Outcome|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
571211|NCT00067808|O1|Outcome|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
571212|NCT00067808|E3|Reported Event|Decitabine 20 mg/m2 SQ|20 mg/m2 subcutaneous (SQ) daily for 5 days
571213|NCT00067808|E2|Reported Event|Decitabine 20 mg/m2 IV|20 mg/m2 IV over 1 hour daily for 5 days
571214|NCT00067808|E1|Reported Event|Decitabine 10 mg/m2 IV|10 mg/m2 by vein (IV) over 1 hour daily for 10 days
571215|NCT00067470|B3|Baseline|Total|Total of all reporting groups
571216|NCT00067470|B2|Baseline|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571217|NCT00067470|B1|Baseline|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571218|NCT00067470|P2|Participant Flow|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571219|NCT00067470|P1|Participant Flow|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571220|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571221|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571222|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571223|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571224|NCT00067470|O2|Outcome|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571225|NCT00067470|O1|Outcome|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571226|NCT00067470|E2|Reported Event|Placebo|Intravenous (IV) placebo solution at a volume equivalent to that needed for a 1.0 mg/kg dose of rhASB
571227|NCT00067470|E1|Reported Event|rhASB|Intravenous (IV) recombinant human arylsulfatase(rhASB) at 1.0 mg/kg
571228|NCT00067236|B3|Baseline|Total|Total of all reporting groups
571229|NCT00067236|B2|Baseline|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
571230|NCT00067236|B1|Baseline|Placebo|Placebo tablet twice daily for 90 days
571231|NCT00067236|P2|Participant Flow|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
571232|NCT00067236|P1|Participant Flow|Placebo|Placebo tablet twice daily for 90 days
571233|NCT00067236|O2|Outcome|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
571234|NCT00067236|O1|Outcome|Placebo|Placebo tablet twice daily for 90 days
571235|NCT00067236|E2|Reported Event|PG-116800 Tablet|PG-116800 tablet (200 mg) twice daily for 90 days
571236|NCT00067236|E1|Reported Event|Placebo|Placebo tablet twice daily for 90 days
571237|NCT00066963|B4|Baseline|Total|Total of all reporting groups
571238|NCT00066963|B3|Baseline|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
571239|NCT00066963|B2|Baseline|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
571240|NCT00066963|B1|Baseline|No Intervention: Counseling Only|Counseling Only (0FV)
571241|NCT00066963|P3|Participant Flow|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
571242|NCT00066963|P2|Participant Flow|Experimental: FV Every 12mo for 24mo + Counsel|Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
571243|NCT00066963|P1|Participant Flow|No Intervention: Counseling Only|Counseling Only (0FV)
571244|NCT00066963|O3|Outcome|FV 2x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
571245|NCT00066963|O2|Outcome|FV 1x/Year + Counseling|fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
571246|NCT00066963|O1|Outcome|Counseling Only|caregiver counseling only (zero fluoride varnish)
571247|NCT00066963|E3|Reported Event|Experimental: FV Every 6mo for 24mo + Counsel|Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
571252|NCT00066807|B1|Baseline|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571253|NCT00066807|P2|Participant Flow|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571254|NCT00066807|P1|Participant Flow|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571255|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571256|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571257|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571258|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571259|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571260|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571261|NCT00066807|O2|Outcome|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571262|NCT00066807|O1|Outcome|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571263|NCT00066807|E2|Reported Event|Chemotherapy Plus OFS Plus T or E for 5 Years|Chemotherapy plus ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571264|NCT00066807|E1|Reported Event|OFS Plus T or E for 5 Years|Ovarian function suppression (OFS) by triptorelin for 5 years or surgical oophorectomy or ovarian irradiation PLUS tamoxifen (T) or exemestane (E) for 5 years.
571265|NCT00066742|B1|Baseline|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
571266|NCT00066742|P1|Participant Flow|Evaluable Patients|Only eligible patients who received the study intervention were included in the analysis.
571267|NCT00066742|O1|Outcome|Evaluable Patients|
571268|NCT00066742|O1|Outcome|Evaluable Patients With Measurable Disease|Only eligible patients who received protocol treatment and who had measurable lesions (per RECIST) at baseline were included in this analysis.
571269|NCT00066742|O1|Outcome|Evaluable Patients|
571270|NCT00066742|E2|Reported Event|Consolidation Cisplatin + Etoposide|
571271|NCT00066742|E1|Reported Event|Tirapazamine + Cisplatin + Etoposide + Concurrent Radiotherapy|
571272|NCT00066703|B3|Baseline|Total|Total of all reporting groups
571273|NCT00066703|B2|Baseline|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571274|NCT00066703|B1|Baseline|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571275|NCT00066703|P2|Participant Flow|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571276|NCT00066703|P1|Participant Flow|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571277|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571278|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571279|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571355|NCT00066170|B2|Baseline|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571280|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571281|NCT00066703|O2|Outcome|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571282|NCT00066703|O1|Outcome|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571283|NCT00066703|E2|Reported Event|E+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus exemestane 25mg orally daily for 5 years. Exemestane (E) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571284|NCT00066703|E1|Reported Event|T+OFS|Ovarian function suppression (OFS) by triptorelin (GnRH analogue) 3.75mg by im injection q28 days for 5 years plus tamoxifen 20mg orally daily for 5 years. Tamoxifen (T) begins after the completion of adjuvant chemotherapy if given, or approximately 6-8 weeks after the initiation of triptorelin. Bilateral oophorectomy or ovarian irradiation was allowed after at least 6 months of triptorelin.
571285|NCT00066690|B4|Baseline|Total|Total of all reporting groups
571286|NCT00066690|B3|Baseline|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571287|NCT00066690|B2|Baseline|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571288|NCT00066690|B1|Baseline|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571289|NCT00066690|P3|Participant Flow|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571290|NCT00066690|P2|Participant Flow|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571291|NCT00066690|P1|Participant Flow|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571292|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571293|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571294|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571295|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571296|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571297|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571298|NCT00066690|O3|Outcome|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571299|NCT00066690|O2|Outcome|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571300|NCT00066690|O1|Outcome|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571301|NCT00066690|E3|Reported Event|E+OFS|Exemestane 25mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571302|NCT00066690|E2|Reported Event|T+OFS|Tamoxifen 20mg orally daily for 5 years plus ovarian function suppression (OFS; triptorelin (GnRH analogue) 3.75 mg by im injection q28 days for 5 years; or surgical oophorectomy; or ovarian irradiation)
571303|NCT00066690|E1|Reported Event|Tamoxifen|Tamoxifen 20mg orally daily for 5 years
571304|NCT00066573|B3|Baseline|Total|Total of all reporting groups
571305|NCT00066573|B2|Baseline|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
571306|NCT00066573|B1|Baseline|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
571307|NCT00066573|P2|Participant Flow|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
571308|NCT00066573|P1|Participant Flow|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
571309|NCT00066573|O2|Outcome|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
571310|NCT00066573|O1|Outcome|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
571311|NCT00066573|E2|Reported Event|Anastrozole|"Patients receive oral anastrozole (1 mg) once daily for 5 years.~anastrozole: Given orally"
571312|NCT00066573|E1|Reported Event|Exemestane|"Patients receive oral exemestane (25 mg) once daily for 5 years.~exemestane: Given orally"
571356|NCT00066170|B1|Baseline|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571313|NCT00066469|B1|Baseline|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
571314|NCT00066469|P1|Participant Flow|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
571315|NCT00066469|O1|Outcome|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
571316|NCT00066469|E1|Reported Event|Cyclophosphamide, Prednisone, Rituximab|Patients receive cyclophosphamide IV over 30-60 minutes on day 1 and oral prednisone or methylprednisolone IV twice daily on days 1-5. During courses 1 and 2 only, patients also receive rituximab IV over 2-5 hours on days 1, 8, and 15. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression, a new primary or secondary malignancy, or unrelated disease.
571317|NCT00066365|B3|Baseline|Total|Total of all reporting groups
571318|NCT00066365|B2|Baseline|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571319|NCT00066365|B1|Baseline|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571320|NCT00066365|P2|Participant Flow|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571321|NCT00066365|P1|Participant Flow|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571322|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571323|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571324|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571325|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571326|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571327|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571328|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571329|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571330|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571331|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571498|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571332|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571333|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571334|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571335|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571336|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571337|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571338|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571339|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571499|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571340|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms~conventional surgery: thoracotomy"
571341|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571342|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571343|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571344|NCT00066365|O2|Outcome|Group 2 (Bilateral Recurrence) - Sargramostim and Thoractomy|"Patients may be enrolled on study either before or after the first thoracotomy procedure. For the first thoracotomy, patients undergo unilateral thoracotomy. Patients receive initial inhalation therapy inhaled GM-CSF, as soon as possible after recovery from first thoracotomy, twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo contralateral thoracotomy on day 22. Beginning on day 29, or as soon as possible, patients begin post-thoracotomy inhalation therapy as above for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571345|NCT00066365|O1|Outcome|Group 1 (Unilateral Recurrence) - Sargramostim and Thoractomy|"Patients receive initial inhalation therapy inhaled sargramostim (GM-CSF) twice daily on days 1-7. Treatment repeats every other week every 14 days for a total of 2 courses. Patients undergo surgical procedure thoracotomy on day 22. Beginning on day 29, or as soon as possible thereafter, patients begin post-thoracotomy inhalation therapy for up to 12 additional courses. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients are followed every 2 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.~sargramostim: given by inhalation, dosage escalation Level 1 Dose: 240 micrograms, Level 2 Dose: 1,000 micrograms, and Level 3 Dose: 1,750 micrograms.~conventional surgery: thoracotomy"
571346|NCT00066365|E2|Reported Event|Group 2 (Bilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
571347|NCT00066365|E1|Reported Event|Group 1 (Unilateral Recurrence)|"(See Detailed Description and Interventions for drugs, dosages, delivery method and frequency.)~sargramostim: given by inhalation~conventional surgery: thoracotomy"
571348|NCT00066222|B1|Baseline|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
571349|NCT00066222|P1|Participant Flow|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic radiation therapy (RT) with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
571350|NCT00066222|O1|Outcome|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
571351|NCT00066222|E1|Reported Event|Radiation Therapy + Chemotherapy|Accelerated high dose thoracic RT with concurrent cisplatin/etoposide chemotherapy, followed by 2 cycles of adjuvant cisplatin/etoposide chemotherapy
571352|NCT00066170|B5|Baseline|Total|Total of all reporting groups
571353|NCT00066170|B4|Baseline|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571354|NCT00066170|B3|Baseline|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571357|NCT00066170|P4|Participant Flow|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571358|NCT00066170|P3|Participant Flow|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571359|NCT00066170|P2|Participant Flow|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571360|NCT00066170|P1|Participant Flow|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571361|NCT00066170|O4|Outcome|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571362|NCT00066170|O3|Outcome|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571363|NCT00066170|O2|Outcome|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571364|NCT00066170|O1|Outcome|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571365|NCT00066170|E4|Reported Event|Xyrem + Modafinil at Established Dose|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571366|NCT00066170|E3|Reported Event|Xyrem Placebo + Modafinil at Established Dose|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil at participant's prior dosage.
571367|NCT00066170|E2|Reported Event|Xyrem + Modafinil Placebo|Xyrem 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571368|NCT00066170|E1|Reported Event|Xyrem Placebo + Modafinil Placebo|Xyrem Placebo volume equivalent to 6 grams per day for the first 4 weeks and 9 grams per day for the remaining 4 weeks + Modafinil Placebo equivalent to prior dosage.
571369|NCT00066066|B4|Baseline|Total|Total of all reporting groups
571370|NCT00066066|B3|Baseline|SRP and Amoxicillin, MET and Locally Delivered Tetracycline|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571371|NCT00066066|B2|Baseline|SRP and Metronidazole (MET)|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571372|NCT00066066|B1|Baseline|Scaling and Root Planing (SRP) Only|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571373|NCT00066066|P6|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571374|NCT00066066|P5|Participant Flow|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571375|NCT00066066|P4|Participant Flow|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571376|NCT00066066|P3|Participant Flow|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571377|NCT00066066|P2|Participant Flow|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571378|NCT00066066|P1|Participant Flow|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571379|NCT00066066|O6|Outcome|SRP + MET + Amoxicillin + Doxycycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571500|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571380|NCT00066066|O5|Outcome|SRP + MET + Amoxicillin + Doxycycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571381|NCT00066066|O4|Outcome|SRP + Metronidazole Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571382|NCT00066066|O3|Outcome|SRP + Metronidazole NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571383|NCT00066066|O2|Outcome|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571384|NCT00066066|O1|Outcome|Scaling and Root Planing Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571385|NCT00066066|E6|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571386|NCT00066066|E5|Reported Event|SRP and Amoxicillin, MET, Local Tetracycline NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days) together with systemically administered amoxicillin (500 mg tid for 14 days) and local delivery of doxycycline (Atridox) at teeth with pockets > 4 mm. Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Tetracycline : Tetracycline is an antibiotic that has proved effective in killing bacteria in the periodontal pocket when applied locally."
571387|NCT00066066|E4|Reported Event|SRP and Metronidazole (MET) Smokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571388|NCT00066066|E3|Reported Event|SRP and Metronidazole (MET) NonSmokers|"In addition to full mouth scaling and root planing under local anesthesia,subjects received systemically administered metronidazole (250 mg tid x 14 days). Maintenance SRP was performed every 3 months for the duration of the study in all subjects.~Metronidazole is an antibiotic that is particularly effective against Gram negative bacterial species."
571389|NCT00066066|E2|Reported Event|SRP Only Smokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571390|NCT00066066|E1|Reported Event|Scaling and Root Planing (SRP) Only NonSmokers|Subjects received full mouth scaling and root planing (SRP) under local anesthesia.Maintenance SRP was performed every 3 months for the duration of the study in all subjects.
571391|NCT00065806|B3|Baseline|Total|Total of all reporting groups
571392|NCT00065806|B2|Baseline|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571393|NCT00065806|B1|Baseline|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571394|NCT00065806|P2|Participant Flow|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571501|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571502|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571395|NCT00065806|P1|Participant Flow|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571396|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571397|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571398|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571399|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571400|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571401|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571402|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571503|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571504|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571505|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571403|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571404|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571405|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571406|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571407|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571408|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571409|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571410|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571506|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571507|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571508|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571411|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571412|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571413|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571414|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571415|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571416|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571417|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571418|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571509|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571510|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571511|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571419|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571420|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571421|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571422|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571423|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571424|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571425|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571426|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571512|NCT00065507|E2|Reported Event|ENTECAVIR|
571513|NCT00065507|E1|Reported Event|ADEFOVIR|
571514|NCT00065468|B4|Baseline|Total|Total of all reporting groups
571847|NCT00063622|B4|Baseline|Total|Total of all reporting groups
571427|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571428|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571429|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571430|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571431|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571432|NCT00065806|O2|Outcome|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571433|NCT00065806|O1|Outcome|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571434|NCT00065806|E2|Reported Event|2 Placebo|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus placebo at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd placebo for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Placebo atorvastatin : Participants weighing more 50 kg will receive 10 mg of placebo po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571515|NCT00065468|B3|Baseline|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571435|NCT00065806|E1|Reported Event|1 Atorvastatin|"Patients will be treated with dietary intervention (AHA Therapeutic Lifestyle Changes [TLC] diet, [http://www.nhlbi.nih.gov/cgi-bin/chd/step2intro.cgi]), cardiovascular risk factor reduction counseling, hydroxychloroquine, low-dose aspirin, a multivitamin containing folate, plus atorvastatin at 10 mg or 20 mg depending on the patient's weight. Patients weighing more than 50 kg will receive 10 mg qd atorvastatin for the first month, which will be increased to 20 mg qd at the Day 30 visit and continue through month 36. Participants weighing less than 50kg will receive a maximum of 10 mg po qd for 36 months.~Atorvastatin : Participants weighing more 50 kg will receive 10 mg of atorvastatin po qd as a starting dose, which will be increased to 20 mg po qd at the Day 30 visit and continue through month 36. Participants weighing less than 50 kg will receive a maximum of 10 mg po qd for 36 months."
571436|NCT00065611|B3|Baseline|Total|Total of all reporting groups
571437|NCT00065611|B2|Baseline|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571438|NCT00065611|B1|Baseline|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571439|NCT00065611|P2|Participant Flow|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571440|NCT00065611|P1|Participant Flow|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571441|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571442|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571443|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571444|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571445|NCT00065611|O2|Outcome|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571446|NCT00065611|O1|Outcome|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571447|NCT00065611|E2|Reported Event|4 Doses Every 4 Weeks Arm|Patients in this arm receive 4 doses every 4 weeks
571448|NCT00065611|E1|Reported Event|2 Doses Every 2 Weeks Arm|Patients in this arm receive 2 doses every 2 weeks
571449|NCT00065507|B3|Baseline|Total|Total of all reporting groups
571450|NCT00065507|B2|Baseline|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571451|NCT00065507|B1|Baseline|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571452|NCT00065507|P2|Participant Flow|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571453|NCT00065507|P1|Participant Flow|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571454|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571455|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571456|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571457|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571458|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571459|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571460|NCT00065507|O4|Outcome|Cumulative - Adefovir (ADV) 10 mg|
571461|NCT00065507|O3|Outcome|Cumulative - Entecavir (ETV) 1.0 mg|
571462|NCT00065507|O2|Outcome|Week 48 - Adefovir (ADV) 10 mg|
571463|NCT00065507|O1|Outcome|Week 48 - Entecavir (ETV) 1.0 mg|
571464|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571465|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571466|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571467|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571468|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571469|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571470|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571471|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571472|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571473|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571474|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571475|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571476|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571477|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571478|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571479|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571480|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571481|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571482|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571483|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571484|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571485|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571486|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571487|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571488|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571489|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571490|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571491|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571492|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571493|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571494|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571495|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571496|NCT00065507|O2|Outcome|Adefovir (ADV) 10 mg|Tablets, Oral, 10 mg once daily
571497|NCT00065507|O1|Outcome|Entecavir (ETV) 1.0 mg|Tablets, Oral, 1 mg once daily
571516|NCT00065468|B2|Baseline|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571517|NCT00065468|B1|Baseline|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571518|NCT00065468|P3|Participant Flow|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571519|NCT00065468|P2|Participant Flow|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571520|NCT00065468|P1|Participant Flow|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571521|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571522|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571523|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571524|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571525|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571526|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571527|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571528|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571529|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571530|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571531|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571532|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571533|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571534|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571535|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571536|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571537|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571538|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571539|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571540|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571541|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571542|NCT00065468|O3|Outcome|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571543|NCT00065468|O2|Outcome|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571544|NCT00065468|O1|Outcome|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571545|NCT00065468|E3|Reported Event|Interferon Alfa and Temsirolimus|Interferon Alfa (Roferon) 6 MU subcutaneously 3 times per week and Temsirolimus (CCI-779) 15 mg IV once per week until disease progression or treatment withdrawal
571546|NCT00065468|E2|Reported Event|Temsirolimus|Temsirolimus (CCI-779) 25 milligrams (mg) intravenously (IV) once per week until disease progression or treatment withdrawal
571583|NCT00065429|E1|Reported Event|IMGN 5 mg/m2|Arm 1, Phase 1
571584|NCT00065260|B3|Baseline|Total|Total of all reporting groups
571547|NCT00065468|E1|Reported Event|Interferon Alfa|Interferon Alfa (Roferon) 3 million units (MU) subcutaneously 3 times per week for 1 week, then 9 MU subcutaneously 3 times per week for 1 week, then 18 MU subcutaneously 3 times per week until disease progression or treatment withdrawal
571548|NCT00065442|B3|Baseline|Total|Total of all reporting groups
571549|NCT00065442|B2|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
571550|NCT00065442|B1|Baseline|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
571551|NCT00065442|P2|Participant Flow|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
571552|NCT00065442|P1|Participant Flow|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
571553|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
571554|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
571555|NCT00065442|O2|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
571556|NCT00065442|O1|Outcome|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
571557|NCT00065442|E2|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consists of 3 doses administered approximately 2 weeks apart.
571558|NCT00065442|E1|Reported Event|APC-Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure. Three complete doses were given at approximately 2 week intervals.
571559|NCT00065429|B8|Baseline|Total|Total of all reporting groups
571560|NCT00065429|B7|Baseline|IMGN 75 mg/m2|Arm 7, Phase 1
571561|NCT00065429|B6|Baseline|IMGN 67.5 mg/m2|Arm 6, Phase 1
571562|NCT00065429|B5|Baseline|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
571563|NCT00065429|B4|Baseline|IMGN 40 mg/m2|Arm 4, Phase 1
571564|NCT00065429|B3|Baseline|IMGN 20 mg/m2|Arm 3, Phase 1
571565|NCT00065429|B2|Baseline|IMGN 10 mg/m2|Arm 2, Phase 1
571566|NCT00065429|B1|Baseline|IMGN 5 mg/m2|Arm 1, Phase 1
571567|NCT00065429|P7|Participant Flow|IMGN 75 mg/m2|Arm 7, Phase 1
571568|NCT00065429|P6|Participant Flow|IMGN 67.5 mg/m2|Arm 6, Phase 1
571569|NCT00065429|P5|Participant Flow|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
571570|NCT00065429|P4|Participant Flow|IMGN 40 mg/m2|Arm 4, Phase 1
571571|NCT00065429|P3|Participant Flow|IMGN 20 mg/m2|Arm 3, Phase 1
571572|NCT00065429|P2|Participant Flow|IMGN 10 mg/m2|Arm 2, Phase 1
571573|NCT00065429|P1|Participant Flow|IMGN 5 mg/m2|Arm 1, Phase 1
571574|NCT00065429|O2|Outcome|Phase II|For Phase II, the planned design was to use a Gehan's two-stage design [4], with a total of 14 patients assigned to each of 2 dose levels. The dose levels to be tested were to be selected after review of the Phase I data and, assuming evidence of efficacy was seen in that phase, were likely to be the MTD and MTD-1.
571575|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
571576|NCT00065429|O1|Outcome|Phase I|The study had a conventional open-label cytotoxic study design to determine the safety, tolerability and MTD, preliminary efficacy signal and PK. Once the MTD was found in Phase I, the study would continue to a Phase II expansion at the MTD and the MTD-1 dose levels determined in Phase I. Infusions given at 1-week intervals were expected to provide intermittent exposure with no accumulation of BB-10901. The maximum duration of treatment at each dose level was 4 cycles of treatment; patients with evidence of response were eligible to continue for up to 6 cycles of treatment. Dose levels planned were 5, 10, 20, 40, 60 and 90 mg/m2/week. Three patients were to be enrolled per dose level with dose escalation when 1 of 3 patients completed 1 cycle and 2 patients had received at least 2 weekly infusions and were eligible for their third infusion, all without DLT. Once the MTD had been defined, 3 more patients were planned for enrollment at the MTD and 3 patients at the MTD-1 level.
571577|NCT00065429|E7|Reported Event|IMGN 75 mg/m2|Arm 7, Phase 1
571578|NCT00065429|E6|Reported Event|IMGN 67.5 mg/m2|Arm 6, Phase 1
571579|NCT00065429|E5|Reported Event|IMGN 60 mg/m2|Arm 5, Phase 1 and 2
571580|NCT00065429|E4|Reported Event|IMGN 40 mg/m2|Arm 4, Phase 1
571581|NCT00065429|E3|Reported Event|IMGN 20 mg/m2|Arm 3, Phase 1
571582|NCT00065429|E2|Reported Event|IMGN 10 mg/m2|Arm 2, Phase 1
571585|NCT00065260|B2|Baseline|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
571586|NCT00065260|B1|Baseline|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
571587|NCT00065260|P2|Participant Flow|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
571588|NCT00065260|P1|Participant Flow|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
571589|NCT00065260|O2|Outcome|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
571590|NCT00065260|O1|Outcome|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
571591|NCT00065260|E2|Reported Event|Alemtuzumab (Campath-1H)|"A randomized trial of rabbit anti-thymocyte globulin (ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~Campath-1H: Campath-1H IV 10 days. Adults:10mg/day (children:0.2mg/kg/day)."
571592|NCT00065260|E1|Reported Event|r-ATG /Cyclosporine|"A randomized trial of rabbit anti-thymocyte globulin (r-ATG)/ cyclosporine (CsA) versus Campath-1H in aplastic anemia patients with refractory pancytopenia or suboptimal hematological response after horse ATG treatment. Subjects who receive rabbit ATG/ CsA will be given rabbit ATG 3.5mg/kg/day for 5 days and CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs. Subjects who receive Campath-1H will receive an intravenous infusion for 10 days. Adult subjects will receive 10mg/day (children:0.2mg/kg/day).~r-ATG: Rabbit ATG 3.5mg/kg/day for consecutive 5 days~CsA: CsA 10mg/kg/day orally twice daily for 6 months (15mg/kg/day for children under 12 yrs."
571593|NCT00065156|B1|Baseline|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571594|NCT00065156|P1|Participant Flow|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571595|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571596|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571597|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571598|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571599|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571600|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571601|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571602|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571603|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571604|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571605|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571606|NCT00065156|O1|Outcome|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571607|NCT00065156|E1|Reported Event|Lenalidomide|The protocol initially employed a syncopated dosage regimen in which 10 mg of lenalidomide was taken orally once daily on Days 1 to 21 of a 28-day cycle, but was subsequently amended to employ a continuous dosage regimen in which 10 mg of lenalidomide was taken without a planned rest period. Participants who initially began therapy on the syncopated regimen and who did not experience dose-limiting adverse events (AEs) were allowed to switch to the continuous regimen.
571608|NCT00065065|B3|Baseline|Total|Total of all reporting groups
571609|NCT00065065|B2|Baseline|Placebo|Identical in appearance to study drug taken twice a day
571610|NCT00065065|B1|Baseline|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
571611|NCT00065065|P2|Participant Flow|Placebo|Placebo identical to study drug twice daily for 12 weeks
571612|NCT00065065|P1|Participant Flow|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily for 12 weeks
571613|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
571614|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
571615|NCT00065065|O2|Outcome|Placebo|Identical in appearance to study drug taken twice a day
571616|NCT00065065|O1|Outcome|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
571617|NCT00065065|E2|Reported Event|Placebo|Identical in appearance to study drug taken twice a day
571618|NCT00065065|E1|Reported Event|Rosiglitazone|rosiglitazone (Avandia): 4mg orally twice daily
571619|NCT00064844|B3|Baseline|Total|Total of all reporting groups
571620|NCT00064844|B2|Baseline|Nicotine Patch Plus Placebo Gum|
571621|NCT00064844|B1|Baseline|Nicotine Patch Plus Active Gum|
571622|NCT00064844|P2|Participant Flow|Nicotine Patch Plus Placebo Gum|
571623|NCT00064844|P1|Participant Flow|Nicotine Patch Plus Active Gum|
571624|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
571625|NCT00064844|O1|Outcome|Nicotine Patch Plus Active Gum|
571626|NCT00064844|O2|Outcome|Nicotine Patch Plus Placebo Gum|
571631|NCT00064792|B2|Baseline|Simvastatin Followed by Placebo|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
571632|NCT00064792|B1|Baseline|Placebo Followed by Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
571633|NCT00064792|P2|Participant Flow|Simvastatin Followed by Placebo|Subjects first received Simvastatin (1mg/kg/day after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol 150mg/kg/day for 12 months. After a 2 month wash out period, they then continued with cholesterol supplementation only.
571634|NCT00064792|P1|Participant Flow|Placebo Followed by Simvastatin|Subjects maintained cholesterol intake of 150mg/kg/day for 12 months. After a 2 month wash out period, they then received Simvastatin 1mg/kg/day (after starting at 0.5mg/kg/day for 6 weeks) in addition to cholesterol.
571635|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
571636|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
571637|NCT00064792|O2|Outcome|Simvastatin|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
571638|NCT00064792|O1|Outcome|Not Simvastatin|During the placebo phase, subjects were given a daily dose of an oral suspension (OraPlus) not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
571639|NCT00064792|E2|Reported Event|Simvastatin Susp|Subjects began this phase by taking 0.5mg/kg/day of an oral suspension with active drug for 6 weeks followed by a daily dose of 1mg/kg/day. Subjects continued taking 150mg/kg/day of cholesterol suspension.
571640|NCT00064792|E1|Reported Event|OraPlus|During the placebo phase, subjects were given a daily dose of an oral suspension not containing active drug. All subjects continued taking cholesterol suspension at 150mg/kg/day.
571641|NCT00064753|B3|Baseline|Total|Total of all reporting groups
571642|NCT00064753|B2|Baseline|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571643|NCT00064753|B1|Baseline|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571644|NCT00064753|P2|Participant Flow|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571645|NCT00064753|P1|Participant Flow|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571646|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571647|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571648|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571649|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571650|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571651|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571652|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571785|NCT00064025|E1|Reported Event|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
571653|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571654|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571655|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571656|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571657|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571658|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571659|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571660|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571661|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571662|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571663|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571664|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571665|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571666|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571667|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571668|NCT00064753|O2|Outcome|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571669|NCT00064753|O1|Outcome|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571670|NCT00064753|E2|Reported Event|Low Dose Multivitamin|"Multivitamin devoid of folic acid and with EAR amounts of vitamin B6 and vitamin B12~Low Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 1.4 mg Folic acid: 0.0 mg Vitamin B12: 2.0 mcg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571824|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
571671|NCT00064753|E1|Reported Event|High Dose Multivitamin|"Multivitamin with increased folic acid, vitamin B6 and vitamin B12~High Dose Multivitamin: Vitamin B6 (Pyridoxine HCl): 50 mg Folic acid: 5.0 mg Vitamin B12: 1.0 mg Vitamin B1 (Thiamine HNO3): 1.5 mg Vitamin B2 (Riboflavin): 1.5 mg Vitamin C (Ascorbic Acid): 60 mg d-Biotin: 300 mcg Niacinamide: 20 mg Pantothenic Acid Calcium Pantothenate): 10 mg"
571672|NCT00064701|B4|Baseline|Total|Total of all reporting groups
571673|NCT00064701|B3|Baseline|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571674|NCT00064701|B2|Baseline|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571675|NCT00064701|B1|Baseline|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571676|NCT00064701|P3|Participant Flow|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571677|NCT00064701|P2|Participant Flow|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571678|NCT00064701|P1|Participant Flow|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571679|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571680|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571681|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571682|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571683|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571684|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571685|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571686|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571760|NCT00064259|P3|Participant Flow|Oblimersen 5 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 5 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
571825|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
571687|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571688|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571689|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571690|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571691|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571692|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571693|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571694|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571695|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571696|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571697|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571698|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571699|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571700|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571701|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571702|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571703|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571704|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571705|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571706|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571707|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571708|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571709|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571710|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571711|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571712|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571713|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571714|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571715|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571716|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571717|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571718|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571719|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571720|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571721|NCT00064701|O3|Outcome|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571722|NCT00064701|O2|Outcome|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571723|NCT00064701|O1|Outcome|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571724|NCT00064701|E3|Reported Event|Cyclosporine|Participants received a first dose of cyclosporine between 4 to 5 mg/kg orally prior to or within 48 hours following the completion of the transplant procedure and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571725|NCT00064701|E2|Reported Event|Tacrolimus Modified Release|Participants received a first dose of tacrolimus modified release between 0.15 and 0.20 mg/kg/day, given as a single oral dose in the morning, prior to or within 48 hours following the completion of the transplant procedure, and subsequently as once daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571726|NCT00064701|E1|Reported Event|Tacrolimus|Participants received a first dose of tacrolimus between 0.075 and 0.10 mg/kg twice daily, orally prior to or within 48 hours of the completion of the transplant procedure, and subsequently as twice daily oral doses adjusted based on clinical evidence of efficacy, blood concentrations of tacrolimus and adverse events. Participants also received 1.0 g mycophenolate mofetil orally twice daily throughout the study.
571727|NCT00064662|B3|Baseline|Total|Total of all reporting groups
571728|NCT00064662|B2|Baseline|Sling|Pubovaginal sling, using autologous rectus fascia
571729|NCT00064662|B1|Baseline|Burch|The Burch colposuspension
571730|NCT00064662|P2|Participant Flow|Sling|Pubovaginal sling, using autologous rectus fascia
571731|NCT00064662|P1|Participant Flow|Burch|The Burch colposuspension
571732|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
571733|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
571734|NCT00064662|O2|Outcome|Sling|Pubovaginal sling, using autologous rectus fascia
571735|NCT00064662|O1|Outcome|Burch|The Burch colposuspension
571736|NCT00064662|E2|Reported Event|Sling|Pubovaginal sling, using autologous rectus fascia
571737|NCT00064662|E1|Reported Event|Burch|The Burch colposuspension
571738|NCT00064350|B4|Baseline|Total|Total of all reporting groups
571739|NCT00064350|B3|Baseline|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm.~To show baseline characteristics for eligible and treated patients in both the randomization phase (the most important part of this study) and the induction phase, this group contains the following patients:~eligible and treated patients who were not randomized (n=194)~randomized patients who were not eligible or did not start treatment in the randomization phase (n=24)~There were 218 patients in this group so the total number of patients is 299 and the entire cohort represents all eligible and treated patients in the induction phase."
571740|NCT00064350|B2|Baseline|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
571761|NCT00064259|P2|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
571762|NCT00064259|P1|Participant Flow|Oblimersen 3 mg/kg/d +Cisplatin 100 mg/m2 +5-FU 1000 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 3 mg/kg/d in combination with CIVI 5-FU 1000 mg/m2/d on days 4 to 7 and cisplatin 100 mg/m2 on day 4.
571741|NCT00064350|B1|Baseline|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
571742|NCT00064350|P3|Participant Flow|Induction, Not Randomized|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity.~Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients in this group did not enter Step 2 (randomization part) after the induction phase."
571743|NCT00064350|P2|Participant Flow|Induction Then Placebo Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization. Patients with responding disease continue to receive sorafenib for up to 1 year in the absence of disease progression.~Randomization: Patients with stable disease after the induction treatment were randomized to either the sorafenib arm or the placebo arm. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease. Patients on the placebo arm receive oral placebo twice daily for up to 1 year in the absence of disease progression or unacceptable toxicity. Patients on the placebo arm who develop disease progression within 1 year after randomization may cross over to sorafenib arm."
571744|NCT00064350|P1|Participant Flow|Induction Then Sorafenib|"Induction: All patients receive oral sorafenib twice daily on days 1-28. Treatment continues for 2 cycles in the absence of disease progression or unacceptable toxicity. Patients with stable disease proceed to randomization.~Randomization: Patients with stable disease after the induction treatment were randomized to receive either sorafenib or placebo. Patients on the sorafenib arm receive sorafenib twice daily for up to 1 year in the absence of disease progression or unacceptable disease.~In the study design, only patients on the placebo arm with progressive disease may cross over to receive sorafenib. Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them."
571745|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
571746|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
571747|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
571748|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
571749|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
571750|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
571751|NCT00064350|O2|Outcome|Placebo|Patients initially received placebo in Step 2 (randomization part)
571752|NCT00064350|O1|Outcome|Sorafenib|Patients initially received Sorafenib in Step 2 (randomization part)
571753|NCT00064350|E5|Reported Event|Crossover: Sorafenib|Patients on the placebo arm who develop progressive disease may cross over to receive sorafenib, and 27 patients from the placebo arm received sorafenib in Step 3 (crossover). Due to drug dispensing error, even though some patients actually received straight sorafenib during Step 2 (randomization) treatment, they were thought to be randomized onto the placebo arm upon progression and unblinding (before finding out the fact of the dispensing error). Consequently, these patients were crossed over to Step 3, and there were 10 of them. In total, 37 patients registered to step 3 (crossover). Of these, 35 patients received treatment and were included in the toxicity analysis for the crossover (step 3) part.
571754|NCT00064350|E4|Reported Event|Randomization (Step 2): Mixed|"After induction treatment, patients with stable disease were randomized to receive either sorafenib or placebo. Due to drug dispensing error, 10 patients from the sorafenib arm and 2 patients from the placebo arm (12 pts in total) received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities."
571755|NCT00064350|E3|Reported Event|Randomization (Step 2): Placebo|"After induction treatment, 46 patients were randomized to the placebo arm. Among these, 40 received treatment. However, due to drug dispensing error, 2 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 38 treated patients were included in the randomization (step 2): placebo group."
571756|NCT00064350|E2|Reported Event|Randomization (Step 2): Sorafenib|"After induction treatment, 59 patients were randomized to the sorafenib arm. Among these, 55 received treatment. However, due to drug dispensing error, 10 of them received mixed treatment with sorafenib and placebo and were categorized into Randomization (Step 2): Mixed group when reporting toxicities. As a result, 45 treated patients were included in the randomization (step 2): sorafenib group."
571757|NCT00064350|E1|Reported Event|Induction: Sorafenib|All patients who received induction treatment (333 patients), regardless of eligibility status, were included in the toxicity analysis.
571758|NCT00064259|B1|Baseline|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
571759|NCT00064259|P4|Participant Flow|Oblimersen 7 mg/kg/d +Cisplatin 75 mg/m2 +5-FU 750 mg/m2|Patients received oblimersen as a continuous intravenous infusion (CIVI) on days 1 to 7 at 7 mg/kg/d in combination with CIVI 5-FU 750 mg/m2/d on days 4 to 7 and cisplatin 75 mg/m2 on day 4.
571783|NCT00064025|O2|Outcome|PR Positive (>0.2)|
571784|NCT00064025|O1|Outcome|PR Negative (<=0.2)|
571763|NCT00064259|O1|Outcome|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
571764|NCT00064259|E1|Reported Event|Oblimersen + Cisplatin + 5-FU|Oblimersen dose levels (3, 5, or 7 mg/kg/d) on days 1 to 7 in combination with 5-FU (1000 mg/m2/d or 750 mg/m2/d) on days 4 to 7 and Cisplatin (100 mg/m2 or 75 mg/m2) on day 4.
571765|NCT00064038|B3|Baseline|Total|Total of all reporting groups
571766|NCT00064038|B2|Baseline|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
571767|NCT00064038|B1|Baseline|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571768|NCT00064038|P3|Participant Flow|Crossover to Lenalidomide+Dexamethasone|"Patients who have progressive or relapsed disease or who experience unacceptable toxicity attributable to dexamethasone dosing level -2 while on blinded treatment, will be unblinded. Patients shown to have been randomized to DEX + Placebo will proceed with crossover registration and Open-Label Induction with DEX + CC-5013or with open-label CC-5013 alone if they are unblinded due to dexamethasone toxicity.~Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity."
571769|NCT00064038|P2|Participant Flow|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
571770|NCT00064038|P1|Participant Flow|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571771|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
571772|NCT00064038|O1|Outcome|Lenalidomide+Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571773|NCT00064038|O3|Outcome|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571774|NCT00064038|O2|Outcome|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
571775|NCT00064038|O1|Outcome|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571776|NCT00064038|E3|Reported Event|Crossover to Rev+Dex|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571777|NCT00064038|E2|Reported Event|Dexamethasone|Patients receive induction therapy comprising DM as in arm I induction and oral placebo on days 1-28. Treatment repeats as in arm I induction. Some patients may then receive maintenance therapy comprising oral DM as in arm I maintenance and oral placebo on days 1-21. Courses repeat as in arm I maintenance.
571778|NCT00064038|E1|Reported Event|Lenalidomide and Dexamethasone|Patients receive induction therapy comprising oral dexamethasone (DM) on days 1-4, 9-12, and 17-20 and oral lenalidomide on days 1-28. Treatment repeats every 35 days for up to 3 courses in the absence of disease progression or unacceptable toxicity. Patients then receive maintenance therapy comprising oral DM on days 1-4 and 15-18 and oral lenalidomide on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
571779|NCT00064025|B1|Baseline|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
571780|NCT00064025|P1|Participant Flow|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
571781|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
571782|NCT00064025|O1|Outcome|Depo-Provera|Depo-Provera (Medroxyprogesterone Acetate) 400 mg IM, Given Once, 21-24 Days Prior to Hysterectomy
571786|NCT00063986|B1|Baseline|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571787|NCT00063986|P1|Participant Flow|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571788|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571789|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571790|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571791|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571792|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571793|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571794|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571795|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571796|NCT00063986|O1|Outcome|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571797|NCT00063986|E1|Reported Event|Minimally Invasive Esophagectomy (MIE)|"Within 4 weeks of registration patients will undergo minimally invasive esophagectomy (MIE). However, there will be up to 5 months allowed between registration and MIE for those patients needing neoadjuvant therapy prior to undergoing MIE.~Only eligible and treated patients are included in the primary analysis."
571798|NCT00063934|B1|Baseline|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571799|NCT00063934|P1|Participant Flow|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571800|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571801|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571802|NCT00063934|O1|Outcome|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571803|NCT00063934|E1|Reported Event|Oblimersen Plus Doxorubicin + Docetaxel|Intravenous Oblimersen 7 mg/kg/day, both Doxorubicin 50 mg/m^2 and Docetaxel 75 mg/m^2 infused on Day 6
571804|NCT00063635|B4|Baseline|Total|Total of all reporting groups
571805|NCT00063635|B3|Baseline|Placebo|Matching placebo
571806|NCT00063635|B2|Baseline|Vitamin E|Vitamin E, 400 IU, twice daily
571807|NCT00063635|B1|Baseline|Metformin|Metformin, 500 mg, twice daily
571808|NCT00063635|P3|Participant Flow|Placebo|Matching placebo
571809|NCT00063635|P2|Participant Flow|Vitamin E|Vitamin E, 400 IU, twice daily
571810|NCT00063635|P1|Participant Flow|Metformin|Metformin, 500 mg, twice daily
571811|NCT00063635|O3|Outcome|Placebo|Matching placebo
571812|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
571813|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
571814|NCT00063635|O3|Outcome|Placebo|Matching placebo
571815|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
571816|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
571817|NCT00063635|O3|Outcome|Placebo|Matching placebo
571818|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
571819|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
571820|NCT00063635|O3|Outcome|Placebo|Matching placebo
571821|NCT00063635|O2|Outcome|Vitamin E|Vitamin E, 400 IU, twice daily
571822|NCT00063635|O1|Outcome|Metformin|Metformin, 500 mg, twice daily
571823|NCT00063635|O3|Outcome|Placebo|Matching placebo
571848|NCT00063622|B3|Baseline|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571849|NCT00063622|B2|Baseline|Vitamin E|Vitamin E at a dose of 800 IU daily
571850|NCT00063622|B1|Baseline|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571851|NCT00063622|P3|Participant Flow|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571852|NCT00063622|P2|Participant Flow|Vitamin E|Vitamin E at a dose of 800 IU daily
571853|NCT00063622|P1|Participant Flow|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571854|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571855|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571856|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571857|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571858|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571859|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571860|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571861|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571862|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571863|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571864|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571865|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571866|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571867|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571868|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571869|NCT00063622|O3|Outcome|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571870|NCT00063622|O2|Outcome|Vitamin E|Vitamin E at a dose of 800 IU daily
571871|NCT00063622|O1|Outcome|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571872|NCT00063622|E3|Reported Event|Placebo|Placebo Pioglitazone and Placebo Vitamin E
571873|NCT00063622|E2|Reported Event|Vitamin E|Vitamin E at a dose of 800 IU daily
571874|NCT00063622|E1|Reported Event|Pioglitazone|Pioglitazone at a dose of 30 mg daily
571875|NCT00063570|B3|Baseline|Total|Total of all reporting groups
571876|NCT00063570|B2|Baseline|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571877|NCT00063570|B1|Baseline|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571878|NCT00063570|P2|Participant Flow|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571879|NCT00063570|P1|Participant Flow|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571880|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571881|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571882|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571883|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571884|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571885|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571886|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571887|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571888|NCT00063570|O2|Outcome|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571889|NCT00063570|O1|Outcome|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571890|NCT00063570|E2|Reported Event|21-Day Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 21 days, until disease progression.~Gemcitabine: 1000 mg/m2, intravenous (IV) on Days 1 and 8 of a 21-day cycle, until disease progression."
571891|NCT00063570|E1|Reported Event|Bi-Weekly Schedule|"Pemetrexed: 500 mg/m2, intravenous (IV), every 14 days, until disease progression.~Gemcitabine: 1500 mg/m2, intravenous (IV), every 14 days, until disease progression."
571892|NCT00063362|B3|Baseline|Total|Total of all reporting groups
571893|NCT00063362|B2|Baseline|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571938|NCT00062751|P4|Participant Flow|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571940|NCT00062751|P2|Participant Flow|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571894|NCT00063362|B1|Baseline|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571895|NCT00063362|P2|Participant Flow|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571896|NCT00063362|P1|Participant Flow|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 milliequivalent/L (mEq/L)."
571897|NCT00063362|O2|Outcome|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571898|NCT00063362|O1|Outcome|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571899|NCT00063362|E2|Reported Event|Lithium + Divalproex + Placebo|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571900|NCT00063362|E1|Reported Event|Lithium + Divalproex + Lamotrigine|"Divalproex : Divalproex was then initiated at 250 mg twice daily and increased slowly over five weeks to a minimum blood level of 50 μg/mL.~Lamotrigine : Patients were assigned in a one to one ratio to adjunctive lamotrigine versus placebo after stratification for illness type (bipolar I versus bipolar II), historical response to lithium (response versus non-response), and length of current exposure to combination treatment with lithium and divalproex (< 2 months versus ≥ 2 months). During Phase 2, patients were continued on the same doses of lithium and divalproex as during the open-label treatment phase and equal capsules of double-blind lamotrigine or matching placebo were gradually added per a structured dosing schedule up to a minimum dose of 150 mg and a maximum.~dose of 200 mg per day.~Lithium : Lithium monotherapy was initiated at 450 mg once daily and titrated slowly over three weeks to a minimum blood level of 0.5 mEq/L."
571901|NCT00063258|B3|Baseline|Total|Total of all reporting groups
571902|NCT00063258|B2|Baseline|Chemotherapy Alone|
571903|NCT00063258|B1|Baseline|Chemotherapy + Tarceva|
571904|NCT00063258|P2|Participant Flow|Chemotherapy Alone|
571905|NCT00063258|P1|Participant Flow|Chemotherapy + Tarceva|
571906|NCT00063258|O2|Outcome|Chemotherapy Alone|
571907|NCT00063258|O1|Outcome|Chemotherapy + Tarceva|
571908|NCT00063258|E2|Reported Event|Chemotherapy Alone|
571909|NCT00063258|E1|Reported Event|Chemotherapy + Tarceva|
571910|NCT00063232|B1|Baseline|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571911|NCT00063232|P1|Participant Flow|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571912|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571939|NCT00062751|P3|Participant Flow|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571913|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571914|NCT00063232|O1|Outcome|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571915|NCT00063232|E1|Reported Event|Metformin|Participants will undergo a complete medical examination, a series of lab tests, and a liver biopsy. They will then start taking a single 500-mg tablet of metformin once a day for 2 weeks, then the same dosage twice a day for 2 more weeks, if they tolerate the first dosage. The dosage will increase to 1,000 mg twice a day for the remaining 44 weeks of the study. After 1 year, participants will undergo a repeat medical examination and liver biopsy.
571916|NCT00063154|B1|Baseline|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571917|NCT00063154|P1|Participant Flow|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571918|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571919|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571920|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571921|NCT00063154|O1|Outcome|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571922|NCT00063154|E1|Reported Event|Pertuzumab|Participants received pertuzumab intravenously on Day 1 of every 3 week cycle for up to 1 year (up to 17 treatment cycles). Subjects received pertuzumab at a loading dose of 840 mg in Cycle 1 followed by a dose of 420 mg in Cycles 2 and beyond.
571923|NCT00062764|B1|Baseline|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571924|NCT00062764|P1|Participant Flow|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571925|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571926|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571927|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571928|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571929|NCT00062764|O1|Outcome|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571930|NCT00062764|E1|Reported Event|Pioglitazone|Patients receive Pioglitazone in a dose of 15 mg daily for at least 1 year; the dose is escalated to 30 mg daily if serum Alanine transaminase levels do not fall to normal by the 1 year pt; if patients have a biochemical response, drug is continued for 3 years.
571931|NCT00062751|B6|Baseline|Total|Total of all reporting groups
571932|NCT00062751|B5|Baseline|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571933|NCT00062751|B4|Baseline|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571934|NCT00062751|B3|Baseline|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571935|NCT00062751|B2|Baseline|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571936|NCT00062751|B1|Baseline|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571937|NCT00062751|P5|Participant Flow|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571941|NCT00062751|P1|Participant Flow|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571942|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571943|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571944|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571945|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571946|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571947|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571948|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571949|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571950|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571951|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571952|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571953|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571954|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571955|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571956|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571957|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571958|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571959|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571960|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571961|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571962|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571963|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571964|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571965|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571966|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571967|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571968|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571969|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571970|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571971|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571972|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571973|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571974|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
572554|NCT00056472|E1|Reported Event|Pharmacotherapy|sertraline plus olanzapine
571975|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571976|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571977|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571978|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571979|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571980|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571981|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571982|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571983|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571984|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571985|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571986|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571987|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571988|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571989|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571990|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571991|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571992|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571993|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571994|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571995|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571996|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
571997|NCT00062751|O5|Outcome|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
571998|NCT00062751|O4|Outcome|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
571999|NCT00062751|O3|Outcome|Let 2.5 mg Alone / Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent 75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
572000|NCT00062751|O2|Outcome|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
572001|NCT00062751|O1|Outcome|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
572002|NCT00062751|E6|Reported Event|Let 2.5 mg Plus 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 75 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
572003|NCT00062751|E5|Reported Event|Let 2.5 mg Plus 25mg Daily CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779).
572004|NCT00062751|E4|Reported Event|After Cross-over to 75 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 25 mg daily dose of Temsirolimus (CCI-779). Includes events reported after the cross-over date for cross-over participants.
572005|NCT00062751|E3|Reported Event|Let 2.5 mg Alone Prior to Cross-over to 75 mg Intermit CCI-779|Letrozole (Let) 2.5 mg administered daily; permitted to cross-over at the time of progression to single-agent intermittent (intermit)75 mg dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779). Includes events reported prior to the cross-over date for cross-over participants.
572006|NCT00062751|E2|Reported Event|Let 2.5 mg Plus 30 mg Intermittent CCI-779|Letrozole (Let) 2.5 mg administered daily with a 30 mg intermittent dose (daily for 5 days every 2 weeks) of Temsirolimus (CCI-779).
572007|NCT00062751|E1|Reported Event|Let 2.5 mg Plus 10 mg Daily CCI-779|Letrozole (Let) 2.5 milligrams (mg) daily administered with a 10 mg daily dose of Temsirolimus (CCI-779).
572008|NCT00062738|B4|Baseline|Total|Total of all reporting groups
572555|NCT00056407|B3|Baseline|Total|Total of all reporting groups
572009|NCT00062738|B3|Baseline|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
572010|NCT00062738|B2|Baseline|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
572011|NCT00062738|B1|Baseline|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
572012|NCT00062738|P3|Participant Flow|Placebo|Placebo was started at 1 pill and could be increased up to three pills, based on investigator discretion.
572013|NCT00062738|P2|Participant Flow|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg, based on investigator discretion. .
572014|NCT00062738|P1|Participant Flow|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
572015|NCT00062738|O3|Outcome|Placebo|Placebo was started at 1 pill and could be increased up to three pills.
572016|NCT00062738|O2|Outcome|Paroxetine|Paroxetine CR was started at 12.5 mg and could be increased up to 37.5 mg.
572017|NCT00062738|O1|Outcome|Nortriptyline|Dosing was flexible with decisions on dose being made at each visit (or between visits if the patient was having troublesome side effects) based on efficacy and tolerability. Nortriptyline was started at 25mg and could be increased up to 75 mg.
572018|NCT00062738|O3|Outcome|Placebo|
572019|NCT00062738|O2|Outcome|Paroxetine|
572020|NCT00062738|O1|Outcome|Nortriptyline|
572021|NCT00062738|E3|Reported Event|Placebo|
572022|NCT00062738|E2|Reported Event|Paroxetine|
572023|NCT00062738|E1|Reported Event|Nortriptyline|
572024|NCT00062647|B3|Baseline|Total|Total of all reporting groups
572025|NCT00062647|B2|Baseline|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
572026|NCT00062647|B1|Baseline|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
572027|NCT00062647|P2|Participant Flow|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
572028|NCT00062647|P1|Participant Flow|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
572029|NCT00062647|O2|Outcome|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
572030|NCT00062647|O1|Outcome|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
572031|NCT00062647|E2|Reported Event|Standard Therapy|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive vancomycin 1 Gram IV (intravenously) every 12 hrs OR nafcillin, oxacillin, or cloxacillin 2 Gram IV (intravenously) every 6 hrs for up to 14 days. Excludes one patient who never started therapy.
572032|NCT00062647|E1|Reported Event|Telavancin|Patients with uncomplicated Staphylococcus aureus bacteremia were randomized to receive telavancin 10 mg/kg/day IV (intravenously) every 12 hrs for up to 14 days. Excludes 1 patient who never started therapy.
572033|NCT00062439|B1|Baseline|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572034|NCT00062439|P1|Participant Flow|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572035|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572036|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572037|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572038|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT/Surgery/Consolidation Chem|Patients were given induction therapy consisting of concurrent cisplatin + etoposide + 45 Gy thoracic radiation given in 25 daily fractions, followed by thoracotomy, followed by consolidation chemotherapy consisting of three cycles of docetaxel.
572039|NCT00062439|O3|Outcome|Consolidation Docetaxel|
572040|NCT00062439|O2|Outcome|Surgery|
572041|NCT00062439|O1|Outcome|Induction Cisplatin/Etoposide + XRT|
572042|NCT00062439|E3|Reported Event|Consolidation Docetaxel|
572043|NCT00062439|E2|Reported Event|Surgery|
572044|NCT00062439|E1|Reported Event|Induction Cisplatin/Etoposide + XRT|
572045|NCT00062010|B1|Baseline|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572046|NCT00062010|P1|Participant Flow|IFN Alpha, 13-Cis-RA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572047|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572048|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572049|NCT00062010|O1|Outcome|IFN 13CRA Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572050|NCT00062010|E1|Reported Event|IFN Alpha, 13-CRA, Paclitaxel|Interferon alpha and 13-cis-retinoic acid given on days 1 and 2 and paclitaxel given on day 2 for six weeks of an eight-week cycle until disease progression or unacceptable toxicity
572051|NCT00061945|B3|Baseline|Total|Total of all reporting groups
572052|NCT00061945|B2|Baseline|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572053|NCT00061945|B1|Baseline|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572054|NCT00061945|P2|Participant Flow|Phase II - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d 1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d 1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d 5,8,11,15,18 & 22, and filgrastim (FIL) SC d 4-11. Ph+ pts imatinib (IMT) PO d 15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d 1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d 1,15 & 29, MTX IV & IT d 1,15 & 19, MTX PO q6 hr d 1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d 3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d 1,8,15 & 22 and CRT PO BID 3x wkly. Ph+ pts IMT PO d1-28 q24 mo
572055|NCT00061945|P1|Participant Flow|Phase I - Alemtuzumab and Combination Chemotherapy|COURSE 1-allopurinol (ALL) orally (PO) 4x daily (QID) d1-14, cyclophosphamide (CTX) intravenously (IV) d1, daunorubicin IV d1-3, vincristine (VCR) IV d1,8,15 & 22, dexamethasone (DEX) PO 2x daily (BID) d1-7 & 15-21, asparaginase (APG) subcutaneously (SC) d5,8,11,15,18 & 22, and filgrastim (FIL) SC d4-11. Ph+ pts imatinib (IMT) PO d15-28 COURSE 2-methotrexate (MTX) intrathecally (IT) d1, cytarabine IV d1-3, DEX eye drops QID d1-4, cotrimoxazole (CRT) PO BID 3x wkly d1-29 and CTX, APG & FIL as course 1. Ph+ pts IMT PO d1-28 COURSE 3-VCR IV d1,15 & 29, MTX IV & IT d1,15 & 19, MTX PO q6 hr d1-2,15-16 & 29-30, mercaptopurine (6-MP) PO d1-35, leucovorin (LCV) IV d 2,16 & 30, LCV PO q6 hr d3-4 & CRT PO BID 3x wkly d1-43. Ph+ pts IMT PO d1-42 COURSE 4-alemtuzumab 10,20 or 30 mg SC 3x wkly q4 wk, acyclovir PO QID q6 mo COURSE 5-course 1 COURSE 6-course 2 COURSE 7-course 3 COURSE 8-6-MP PO, VCR IV d1, DEX PO d1-5, MTX PO d1,8,15 & 22 and CRT PO BID 3d wkly. Ph+ pts IMT PO d1-28 q24 mo
572056|NCT00061945|O2|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description
572057|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description
572058|NCT00061945|O1|Outcome|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572059|NCT00061945|O1|Outcome|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572060|NCT00061945|E2|Reported Event|Phase II - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572061|NCT00061945|E1|Reported Event|Phase I - Alemtuzumab and Combination Chemotherapy|See detailed description or participant flow.
572062|NCT00061932|B3|Baseline|Total|Total of all reporting groups
572063|NCT00061932|B2|Baseline|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
572064|NCT00061932|B1|Baseline|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
572065|NCT00061932|P2|Participant Flow|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
572066|NCT00061932|P1|Participant Flow|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV 1.3 mg/m2 over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV 125 mg/m2 over 90 minutes on days 1 and 8.~bortezomib: Given IV (1.3 mg/m2)~irinotecan: Given IV (125 mg/m2)"
572067|NCT00061932|O2|Outcome|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
572068|NCT00061932|O1|Outcome|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
572069|NCT00061932|E2|Reported Event|Stratum 2 (Previously Treated)|"(closed to accrual as of 9/19/2006): Patients receive bortezomib as in stratum 1.~bortezomib: Given IV~irinotecan: Given IV"
572070|NCT00061932|E1|Reported Event|Stratum 1 (Previously Untreated)|"Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11 and irinotecan IV over 90 minutes on days 1 and 8.~bortezomib: Given IV~irinotecan: Given IV"
572071|NCT00061893|B1|Baseline|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
572643|NCT00056160|E1|Reported Event|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572072|NCT00061893|P1|Participant Flow|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
572073|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
572074|NCT00061893|O1|Outcome|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
572075|NCT00061893|E1|Reported Event|Combination Chemotherapy|Metastatic Ewing Sarcoma - 14-cycle study building on conventional tx (cyclophosphamide, doxorubicin hydrochloride, vincristine sulfate, ifosfamide, etoposide) and adding two antiangiogenic agents: the vinca alkaloid vinblastine and the cyclooxygenase-2 inhibitor celecoxib. Angiogenesis may be a suitable target for cancer therapy because tumor growth is partially dependent upon neovascularization. Vinblastine sulfate has been shown to have antiangiogenic activity and in preclinical studies, celecoxib has demonstrated antiangiogenic activity as well as inducing apoptosis in tumor vessel endothelial cells. The feasibility and safety of adding antiangiogenic agents to conventional chemotherapy will be assessed by imaging studies (DeMRI, PET, Thallium scintigraphy). Local control with conventional surgery, radiation therapy or both will be tailored for each patient to optimally treat all sites of disease.
572076|NCT00061633|B3|Baseline|Total|Total of all reporting groups
572077|NCT00061633|B2|Baseline|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
572078|NCT00061633|B1|Baseline|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
572079|NCT00061633|P2|Participant Flow|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
572080|NCT00061633|P1|Participant Flow|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
572081|NCT00061633|O2|Outcome|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
572082|NCT00061633|O1|Outcome|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
572083|NCT00061633|E2|Reported Event|Standard of Care for cSSSI|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive standard therapy, defined as vancomycin 1 Gram every 12 hours IV (intravenously) or an antistaphylococcal (semisynthetic) penicillin.
572084|NCT00061633|E1|Reported Event|Telavancin|Patients with complicated Gram-positive skin and skin structure infections were randomized to receive telavancin 10 mg/kg/day IV (intravenously)
572085|NCT00061373|B3|Baseline|Total|Total of all reporting groups
572086|NCT00061373|B2|Baseline|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572087|NCT00061373|B1|Baseline|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572088|NCT00061373|P2|Participant Flow|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572135|NCT00060840|O1|Outcome|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
572089|NCT00061373|P1|Participant Flow|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572090|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572091|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572092|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572093|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572094|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572095|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572096|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572097|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572098|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572099|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572100|NCT00061373|O2|Outcome|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572101|NCT00061373|O1|Outcome|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572102|NCT00061373|E2|Reported Event|Non-MRI Selected Patients|"Patients eligible for the non-MRI arm met all clinical inclusion-exclusion criteria, had MRI is contraindications or the acquisition of MRI would have compromised iv tPA delivery within the standard treatment window.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572103|NCT00061373|E1|Reported Event|MRI- Selected Patients|"Patients eligible for the MRI arm met all clinical and MRI inclusion and exclusion criteria.~Patients received a single dose of aspirin 81 mg orally (or rectal dose equivalent)and a single SQ dose of tinzaparin sodium, 80 anti-Xa IU/kg as soon after iv tPA and consent but within 6 hours of the start of iv tPA."
572104|NCT00061048|B1|Baseline|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572105|NCT00061048|P1|Participant Flow|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572106|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572136|NCT00060840|E2|Reported Event|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
572107|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572108|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572109|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572110|NCT00061048|O1|Outcome|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572111|NCT00061048|E1|Reported Event|Campath-1H Treatment of Adult T-cell Leukemia (ATL)|Intravenous Campath-1H 3 mg on day #1, 10mg on day #2, and 30mg on day #3 followed by maintenance Campath-1H 30 mg intravenously three times per week. Patients are eligible to receive a maximum of 12 weeks of maintenance Campath-1H treatment.
572112|NCT00060944|B3|Baseline|Total|Total of all reporting groups
572113|NCT00060944|B2|Baseline|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572114|NCT00060944|B1|Baseline|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572115|NCT00060944|P2|Participant Flow|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572116|NCT00060944|P1|Participant Flow|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572117|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572118|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572119|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572120|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572121|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572122|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572123|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572124|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572125|NCT00060944|O2|Outcome|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572126|NCT00060944|O1|Outcome|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572127|NCT00060944|E2|Reported Event|Trabectedin 0.58 mg/m2|Participants received trabectedin as a 3-hour intravenous (IV) infusion at a starting dose of 0.58 mg/m2 on Days 1, 8, and 15 of each 28-day treatment cycle, with 10 mg dexamethasone administered IV 30 min before each trabectedin infusion
572128|NCT00060944|E1|Reported Event|Trabectedin 1.5 mg/m2|Participants received trabectedin as a 24-hour intravenous (IV) infusion at a starting dose of 1.5 mg/m2 on Day 1 of each 21-day treatment cycle, with 20 mg dexamethasone administered IV 30 min before each trabectedin infusion.
572129|NCT00060840|B3|Baseline|Total|Total of all reporting groups
572130|NCT00060840|B2|Baseline|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
572131|NCT00060840|B1|Baseline|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
572132|NCT00060840|P2|Participant Flow|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
572133|NCT00060840|P1|Participant Flow|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
572134|NCT00060840|O2|Outcome|Nitrogen|Nitrogen (N2) administered through the INOvent delivery system to subjects at 40 ppm for up to 48 hours.
572137|NCT00060840|E1|Reported Event|Inhaled Nitric Oxide|Inhaled Nitric Oxide (iNO) administered through the INOvent delivery system to subjects at 40 parts per million (ppm) for up to 48 hours
572138|NCT00060528|B1|Baseline|Prostate Cancer Patients|Progressive Metastatic Castration Resistant Prostate Cancer
572139|NCT00060528|P4|Participant Flow|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
572140|NCT00060528|P3|Participant Flow|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
572141|NCT00060528|P2|Participant Flow|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
572142|NCT00060528|P1|Participant Flow|no GM|Vaccine subcutaneously with no GM
572143|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
572144|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8)with efficacy and immunological response as a primary endpoint.
572145|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms: e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
572146|NCT00060528|O1|Outcome|Phase 2|Phase 2 patients are randomized between 4 arms:e.g. No GM, Rec-hGM, rF-GM (10^7pfu), rF-GM (10^8) with efficacy and immunological response as a primary endpoint.
572147|NCT00060528|O4|Outcome|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
572148|NCT00060528|O3|Outcome|rF-GM (10^7pfu),|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
572149|NCT00060528|O2|Outcome|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
572150|NCT00060528|O1|Outcome|No GM|Vaccine subcutaneously with no GM
572151|NCT00060528|E4|Reported Event|rF-GM (10^8)|Vaccine subcutaneously with rF-GM (10^8) subcutaneously x1
572152|NCT00060528|E3|Reported Event|rF-GM (10^7pfu)|Vaccine subcutaneously with rF-GM (10^7pfu) subcutaneously x1
572153|NCT00060528|E2|Reported Event|Rec-hGM|Vaccine subcutaneously with Rec-hGM sucutaneously (daily x 4/vaccine)
572154|NCT00060528|E1|Reported Event|no GM|Vaccine subcutaneously with no GM
572155|NCT00060346|B1|Baseline|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
572156|NCT00060346|P1|Participant Flow|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
572157|NCT00060346|O1|Outcome|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
572158|NCT00060346|E1|Reported Event|Rituximab + CHOP|"Rituximab 375 mg/m2 day 1 of a 21-day cycle, followed by:~Cyclophosphamide 750 mg/m2 Doxorubicin 50 mg/m2 Vincristine 1.4 mg/m2 and Prednisone 100 mg/m2 daily"
572159|NCT00060008|B1|Baseline|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
572160|NCT00060008|P1|Participant Flow|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
572161|NCT00060008|O2|Outcome|SUVmax >2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
572162|NCT00060008|O1|Outcome|SUVmax < 2|Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
572163|NCT00060008|E1|Reported Event|18FDG-PET Scan and MR Perfusion|"Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.~fludeoxyglucose F 18~gadopentetate dimeglumine"
572164|NCT00059839|B3|Baseline|Total|Total of all reporting groups
572165|NCT00059839|B2|Baseline|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572166|NCT00059839|B1|Baseline|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572203|NCT00059475|O7|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
572204|NCT00059475|O6|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
572167|NCT00059839|P2|Participant Flow|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572168|NCT00059839|P1|Participant Flow|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572169|NCT00059839|O2|Outcome|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572170|NCT00059839|O1|Outcome|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572171|NCT00059839|E2|Reported Event|Consolidation (Includes Vinblastine) (Arm II)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV, methotrexate (age adjusted dosing) IT, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) IV over 1 minute on days 1, 8, and 15. In courses 4 and 5, patients receive doxorubicin hydrochloride (30 mg/m2) IV, prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in arm I and vinblastine sulfate (4 mg/m2) as in arm II (courses 1-3). In courses 6-15, patients receive prednisone (120 mg/m2/day) and mercaptopurine (225 mg/m2) as in arm I, vinblastine sulfate (4 mg/m2) IV as in arm II (courses 1-3), and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572172|NCT00059839|E1|Reported Event|Standard (APO) With Vincristine (Arm I)|In courses 1-3, patients receive doxorubicin hydrochloride (30 mg/m2) IV over 15 minutes, vincristine sulfate (1.5 mg/m2 (maximum dose 2 mg)) IV, and methotrexate intrathecally (age-adjusted dosing) (IT) on day 1 and oral prednisone (40 mg/m2/day) three times daily and oral mercaptopurine (225 mg/m2) once daily on days 1-5. In courses 4 and 5, patients receive doxorubicin (30 mg/m2), vincristine sulfate (1.5 mg/m2 (Maximum dose 2 mg)), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3. In courses 6-15, patients receive vincristine sulfate (1.5 mg/m2), prednisone (120 mg/m2/day), and mercaptopurine (225 mg/m2) as in courses 1-3 and methotrexate (60 mg/m2) IV on day 1. Treatment repeats every 21 days for up to 15 courses in the absence of disease progression or unacceptable toxicity.
572173|NCT00059787|B1|Baseline|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572174|NCT00059787|P1|Participant Flow|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572175|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572205|NCT00059475|O5|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
572176|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572177|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
572178|NCT00059787|O1|Outcome|Paclitaxel, Carboplatin, Erlotinib|"Carboplatin and paclitaxel IV every 21 days x 6 cycles plus oral erlotinib~paclitaxel: Given IV~carboplatin: Given IV~erlotinib: Given PO"
572179|NCT00059787|O1|Outcome|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572180|NCT00059787|E1|Reported Event|Treatment (Paclitaxel, Carboplatin, Erlotinib Hydrochloride)|"Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30 minutes on day 1. Patients also receive oral erlotinib daily. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients who achieve a pathologic complete response, those initially suboptimally debulked with a response, and patients who elect not to undergo surgical reassessment but who achieve a complete clinical response receive maintenance erlotinib for an additional 12 months.~paclitaxel: Given IV~carboplatin: Given IV~erlotinib hydrochloride: Given PO~laboratory biomarker analysis: Correlative studies"
572181|NCT00059475|B9|Baseline|Total|Total of all reporting groups
572182|NCT00059475|B8|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
572183|NCT00059475|B7|Baseline|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
572184|NCT00059475|B6|Baseline|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
572185|NCT00059475|B5|Baseline|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
572186|NCT00059475|B4|Baseline|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
572187|NCT00059475|B3|Baseline|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
572188|NCT00059475|B2|Baseline|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
572189|NCT00059475|B1|Baseline|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
572190|NCT00059475|P8|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
572191|NCT00059475|P7|Participant Flow|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
572192|NCT00059475|P6|Participant Flow|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
572193|NCT00059475|P5|Participant Flow|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
572194|NCT00059475|P4|Participant Flow|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
572195|NCT00059475|P3|Participant Flow|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
572196|NCT00059475|P2|Participant Flow|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
572197|NCT00059475|P1|Participant Flow|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
572198|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
572199|NCT00059475|O3|Outcome|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
572200|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
572201|NCT00059475|O1|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
572202|NCT00059475|O8|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
572206|NCT00059475|O4|Outcome|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
572207|NCT00059475|O3|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
572208|NCT00059475|O2|Outcome|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
572209|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
572210|NCT00059475|O4|Outcome|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
572211|NCT00059475|O3|Outcome|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
572212|NCT00059475|O2|Outcome|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
572213|NCT00059475|O1|Outcome|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
572214|NCT00059475|E8|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 + gp209-2M|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm IV (Arm IVA)
572215|NCT00059475|E7|Reported Event|Adj-2 27-35 (27L): MART-1 + gp100: 209-217 (210M) Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide plus the gp100:209-217(210M) peptide emulsified together every three weeks for four cycles (Arm IV).
572216|NCT00059475|E6|Reported Event|Adj-2 HD IL-2 After MART-1: 26-35 (27L) (Mod10mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm III (Arm IIIA)
572217|NCT00059475|E5|Reported Event|Adj-2 MART-1: 26-35 (27L) (Mod10mer) Peptide Q3wks x 4|melanoma antigen recognized by T-cells (MART)-1:26-35(27L) peptide every three weeks for four cycles (Arm III).
572218|NCT00059475|E4|Reported Event|Adj-2 HD IL-2 After 27-35 (27L): MART-1 (Mod9mer)|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm II (Arm IIA)
572219|NCT00059475|E3|Reported Event|Adj-2 27-35 (27L) MART-1 (Mod9mer) Peptide Q3wks x 4|27-35(27L):melanoma antigen recognized by T-cells (MART)-1 peptide every three weeks for four cycles (Arm II).
572220|NCT00059475|E2|Reported Event|Adj-2 HD IL-2 After MART-1: 27-35|High-dose (HD) bolus interleukin-2 (IL-2) (720,000 IU/kg every 8 hours for up to 12 doses) after enrollment on Arm I (Arm IA)
572221|NCT00059475|E1|Reported Event|Adj-2 MART-1: 27-35|melanoma antigen recognized by T-cells (MART)-1:27-35 peptide every three weeks for four cycles (Arm I).
572222|NCT00059332|B3|Baseline|Total|Total of all reporting groups
572223|NCT00059332|B2|Baseline|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572224|NCT00059332|B1|Baseline|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572225|NCT00059332|P2|Participant Flow|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572226|NCT00059332|P1|Participant Flow|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572227|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572228|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572229|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572230|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572231|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572232|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572233|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572234|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572235|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572236|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572237|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572238|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572239|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572240|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572241|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572242|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572243|NCT00059332|O2|Outcome|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572244|NCT00059332|O1|Outcome|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572245|NCT00059332|E2|Reported Event|Magnesium Sulfate|Magnesium Sulfate: Paramedics initiate a loading dose of 4 grams magnesium sulfate IV over 15 minutes, followed after hospital arrival by a maintenance infusion of 16 grams magnesium sulfate IV over 24 hours.
572246|NCT00059332|E1|Reported Event|Normal Saline|Normal Saline: Paramedics initiate a loading dose of placebo normal saline IV over 15 minutes, followed after hospital arrival by a maintenance infusion of placebo normal saline IV over 24 hours.
572247|NCT00059215|B5|Baseline|Total|Total of all reporting groups
572248|NCT00059215|B4|Baseline|Clopidogrel|Clopidogrel 300-mg oral LD at time of PCI followed by an oral 75-mg MD; taken once a day
572249|NCT00059215|B3|Baseline|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
572250|NCT00059215|B2|Baseline|Prasugrel (CS-747) 60 mg LD/10 mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
572251|NCT00059215|B1|Baseline|Prasugrel (CS-747) 40 mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
572252|NCT00059215|P4|Participant Flow|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572253|NCT00059215|P3|Participant Flow|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
572254|NCT00059215|P2|Participant Flow|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
572255|NCT00059215|P1|Participant Flow|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40 mg oral loading dose (LD) at time of percutaneous coronary intervention (PCI) followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
572256|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
572257|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572258|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
572259|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
572260|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
572261|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
572262|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572263|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
572264|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
572265|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
572266|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
572267|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572268|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
572269|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
572270|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
572271|NCT00059215|O5|Outcome|Prasugrel (CS-747) Combined|All evaluable patients in the 3 prasugrel (CS-747) treatment arms
572272|NCT00059215|O4|Outcome|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572273|NCT00059215|O3|Outcome|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 15 mg oral maintenance dose (MD), once daily, for 29-34 days
572274|NCT00059215|O2|Outcome|Prasugrel (CS-747) 60-mg LD/10-mg MD|Prasugrel (CS-747) 60 mg oral loading dose (LD) at time of PCI followed by 10 mg oral maintenance dose (MD), once daily, for 29-34 days
572275|NCT00059215|O1|Outcome|Prasugrel (CS-747) 40-mg LD/7.5-mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5 mg oral maintenance dose (MD), once daily, for 29-34 days
572276|NCT00059215|E4|Reported Event|Clopidogrel|Clopidogrel 300 mg oral LD at time of PCI followed by an oral 75 mg MD; taken once a day.
572277|NCT00059215|E3|Reported Event|Prasugrel (CS-747) 60-mg LD/15-mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 15-mg oral maintenance dose (MD), once daily, for 29-34 days
572278|NCT00059215|E2|Reported Event|Prasugrel (CS-747) 60-mg LD/10 mg MD|Prasugrel (CS-747) 60-mg oral loading dose (LD) at time of PCI followed by 10-mg oral maintenance dose (MD), once daily, for 29-34 days
572279|NCT00059215|E1|Reported Event|Prasugrel (CS-747) 40-mg LD/7.5 mg MD|Prasugrel (CS-747) 40-mg oral loading dose (LD) at time of PCI followed by 7.5-mg oral maintenance dose (MD), once daily, for 29-34 days
572280|NCT00058825|B1|Baseline|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572281|NCT00058825|P1|Participant Flow|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572282|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
572283|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
572284|NCT00058825|O2|Outcome|CLINIMACs|The CLINIMACS CD34 Reagent system was used for cell selection.
572285|NCT00058825|O1|Outcome|Isolex|The Isolex system was used for cell selection.
572286|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572287|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572288|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572289|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572290|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572291|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572292|NCT00058825|O1|Outcome|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572293|NCT00058825|E1|Reported Event|Stem Cell Transplant|"Total body irradiation (TBI); Fludarabine and Campath 1H; FK506 or Cyclosporine; Stem Cell Transplant; G-CSF.~Campath 1H: Day -5 to Day -2: Campath 1H dose schedule as per institutional SOP.~Fludarabine: Day -5 to Day -2: Fludarabine 30 mg/m2.~Stem Cell Transplant: Day 0: Donor stem cells infused.~Total Body Irradiation (TBI): Day -6: Total body irradiation of 600 cGy as two doses without blocks at a rate of less than or equal to 10 cGy/minute.~FK506 (Tacrolimus) or Cyclosporine: Day -2: FK506 or Cyclosporine as medically indicated to prevent GvHD."
572294|NCT00058552|B3|Baseline|Total|Total of all reporting groups
572295|NCT00058552|B2|Baseline|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572296|NCT00058552|B1|Baseline|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572297|NCT00058552|P2|Participant Flow|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572298|NCT00058552|P1|Participant Flow|Pertuzumab 420 mg|Participants in this group received pertuzumab intravenous (IV) infusion at a loading dose of 840 milligrams (mg) for Cycle 1 (1 Cycle equals to [=] 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572299|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572300|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab at a loading dose of 840 mg for Cycle 1, followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression (1 Cycle = 3 Weeks).
572301|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572302|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572303|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572304|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572305|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572306|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572307|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572308|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572309|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572310|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572311|NCT00058552|O2|Outcome|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572312|NCT00058552|O1|Outcome|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572313|NCT00058552|E2|Reported Event|Pertuzumab 1050 mg|Participants in this group received 1050 mg of pertuzumab IV infusion at each cycle (1 Cycle = 3 Weeks) up to 1 year (17 cycles) or until disease progression.
572314|NCT00058552|E1|Reported Event|Pertuzumab 420 mg|Participants in this group received pertuzumab IV infusion at a loading dose of 840 mg for Cycle 1 (1 Cycle = 3 Weeks), followed by 420 mg for Cycles 2 and beyond, up to 1 year (17 cycles) or until disease progression.
572315|NCT00058539|B1|Baseline|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572316|NCT00058539|P1|Participant Flow|Pertuzumab|All the participants received a loading dose of 840 milligrams (mg) of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an intravenous (IV) infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572317|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572318|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572413|NCT00057746|B4|Baseline|Total|Total of all reporting groups
572319|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572320|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572321|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572322|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572323|NCT00058539|O1|Outcome|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572324|NCT00058539|E1|Reported Event|Pertuzumab|All the participants received a loading dose of 840 mg of pertuzumab on Day 1 of Cycle 1, followed by 420 mg on Day 1 of each subsequent 21-day cycle. Pertuzumab was administered as an IV infusion every 3 weeks for up to 1 year (17 cycles) for participants who showed no evidence of progression. Participants with evidence of disease progression could have continued pertuzumab therapy, at the discretion of the investigator, if they had improvement in pain without an increase in narcotic use and if they had no other therapeutic options.
572325|NCT00058214|B1|Baseline|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
572326|NCT00058214|P1|Participant Flow|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
572327|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
572328|NCT00058214|O1|Outcome|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
572329|NCT00058214|E1|Reported Event|Treatment (Perifosine)|"Patients receive oral perifosine 100 mg once daily on days 1-28. On day 1 of course 1 only, patients receive 2 doses of oral perifosine at 450 mg. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients with progressive disease by PSA alone may receive up to 3 additional courses of therapy after documentation of progression.~perifosine: Given orally~laboratory biomarker analysis: Correlative studies"
572330|NCT00058019|B3|Baseline|Total|Total of all reporting groups
572331|NCT00058019|B2|Baseline|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572332|NCT00058019|B1|Baseline|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572333|NCT00058019|P2|Participant Flow|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572334|NCT00058019|P1|Participant Flow|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572414|NCT00057746|B3|Baseline|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
572335|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572336|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572337|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572338|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572339|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572340|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572341|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572342|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572343|NCT00058019|O2|Outcome|Cohort 2 (Chmoresistant)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 2(Chemoresistant) enrolled patients with stable disease but less than a partial response to their most recent therapy.
572344|NCT00058019|O1|Outcome|Cohort 1 (Chemosensitive)|Ixabepilone was administered intravenously at a dose of 20 mg/m^2 over 1 hour weekly on days 1,8, and 15 of a 28-day cycle. Cohort 1(Chemosensitive) enrolled patients with a complete response or partial response lasting at least 4 weeks to their most recent therapy.
572345|NCT00058019|E1|Reported Event|Ixabeilone for Relapsed Aggressive NHL|
572346|NCT00057954|B1|Baseline|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
572347|NCT00057954|P1|Participant Flow|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
572348|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
572349|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
572350|NCT00057954|O1|Outcome|Transplant|Reduced toxicity conditioning regimen followed by allogeneic (sibling or unrelated) transplant.
572351|NCT00057954|E1|Reported Event|Transplant|Reduced toxicity conditioning regimen followed by allogeneic sibling or unrelated transplant.
572352|NCT00057941|B3|Baseline|Total|Total of all reporting groups
572353|NCT00057941|B2|Baseline|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
572354|NCT00057941|B1|Baseline|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
572355|NCT00057941|P2|Participant Flow|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
572356|NCT00057941|P1|Participant Flow|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
572357|NCT00057941|O2|Outcome|Fulvestrant and ZD1839|
572358|NCT00057941|O1|Outcome|Anastrozole and ZD1839|
572359|NCT00057941|E2|Reported Event|Arm II (Fulvestrant and ZD1839)|Patients receive fulvestrant intramuscularly on day 1 and oral gefitinib once daily on days 1-28.
572360|NCT00057941|E1|Reported Event|Arm I (Anastrozole and ZD1839)|Patients receive oral anastrozole and oral gefitinib once daily on days 1-28.
572361|NCT00057876|B3|Baseline|Total|Total of all reporting groups
572362|NCT00057876|B2|Baseline|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572363|NCT00057876|B1|Baseline|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572364|NCT00057876|P2|Participant Flow|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572365|NCT00057876|P1|Participant Flow|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572366|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572367|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572368|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572369|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572370|NCT00057876|O2|Outcome|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572371|NCT00057876|O1|Outcome|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572372|NCT00057876|E2|Reported Event|Gemcitabine + Radiation|"Induction: Patients will receive gemcitabine 600 mg/m² intravenous infusion over 30-60 minutes once a week for 6 weeks while receiving radiation therapy. The first gemcitabine dose will be given on the first day of radiation therapy (prior to radiation), then weekly thereafter. All patients on Arm B will receive radiation therapy Monday through Friday (no radiation on Saturday or Sunday), weeks 1-6, with once/week gemcitabine. The radiation dose per fraction will be 180 cGy prescribed to the isocenter. The total dose of radiation will be 5040 cGy given in 28 fractions over 5 1/2 weeks.~Consolidation: Additional cycles of gemcitabine will begin approximately 4 weeks after completion of radiation therapy."
572373|NCT00057876|E1|Reported Event|Gemcitabine|"Induction: Patients will receive the first cycle of gemcitabine 1000 mg/m² intravenously once per week for 6 weeks followed by 1 week rest.~Consolidation: Following the week of rest, treatment will resume with 1000 mg/m² administered intravenously once per week for 3 weeks, followed by 1 week rest, for 5 (4-week) cycles."
572374|NCT00057863|B1|Baseline|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572375|NCT00057863|P1|Participant Flow|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572376|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572377|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572378|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572379|NCT00057863|O1|Outcome|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572380|NCT00057863|E1|Reported Event|Treatment (Paclitaxel, Oxaliplatin)|"Patients receive paclitaxel IV over 3 hours and oxaliplatin IV over 2 hours on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.~Paclitaxel: Given IV~Oxaliplatin: Given IV"
572381|NCT00057837|B3|Baseline|Total|Total of all reporting groups
572382|NCT00057837|B2|Baseline|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572415|NCT00057746|B2|Baseline|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
572383|NCT00057837|B1|Baseline|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572384|NCT00057837|P2|Participant Flow|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572385|NCT00057837|P1|Participant Flow|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572386|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572387|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572388|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572389|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572390|NCT00057837|O2|Outcome|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572391|NCT00057837|O1|Outcome|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572392|NCT00057837|E2|Reported Event|PIE (Irinotecan/Cisplatin/Etoposide)|Patients receive irinotecan IV over 90 minutes and cisplatin IV over 60 minutes on days 1 and 8 and oral etoposide twice daily on days 3 and 10 of each cycle.
572393|NCT00057837|E1|Reported Event|PET (Topotecan/Etoposide/Cisplatin/G-CSF)|Patients receive topotecan intravenously (IV) over 30 minutes on days 1-3; etoposide IV over 60 minutes immediately followed by cisplatin IV over 60 minutes on days 8-10; and filgrastim (G-CSF) subcutaneously daily beginning on day 11 and continuing until blood counts recover.
572394|NCT00057811|B3|Baseline|Total|Total of all reporting groups
572395|NCT00057811|B2|Baseline|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572396|NCT00057811|B1|Baseline|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572397|NCT00057811|P2|Participant Flow|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572398|NCT00057811|P1|Participant Flow|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572399|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572400|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572401|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572402|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572403|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572404|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572405|NCT00057811|O2|Outcome|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572406|NCT00057811|O1|Outcome|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572407|NCT00057811|E2|Reported Event|Group C (Chemotherapy, Monoclonal Antibody Therapy)|Therapies given IV, IT, orally, or subcutaneously (same as FAB B with the addition of etoposide and high-dose methotrexate). See Detailed Description.
572408|NCT00057811|E1|Reported Event|Group B (Chemotherapy, Protective Therapy, Monoclonal Antib.)|Therapies given IV, IT, orally, or SC. Please see treatment outline. See Detailed Description.
572409|NCT00057785|B1|Baseline|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
572410|NCT00057785|P1|Participant Flow|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
572411|NCT00057785|O1|Outcome|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
572412|NCT00057785|E1|Reported Event|IMRT +/- Chemotherapy|Intensity modulated radiation therapy (IMRT) for all patients and chemotherapy (cisplatin and fluorouracil) for patients with stage ≥ T2b and/or N+
572416|NCT00057746|B1|Baseline|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
572417|NCT00057746|P3|Participant Flow|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
572418|NCT00057746|P2|Participant Flow|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
572419|NCT00057746|P1|Participant Flow|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
572420|NCT00057746|O3|Outcome|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
572421|NCT00057746|O2|Outcome|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
572422|NCT00057746|O1|Outcome|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
572423|NCT00057746|E3|Reported Event|Arm III|Prophylactic cranial irradiation, 1.5 Gy FX: Prophylactic cranial irradiation, 1.5 Gy twice daily, M-F, in 24 fractions for a total dose of 36 Gy
572424|NCT00057746|E2|Reported Event|Arm II|Prophylactic cranial irradiation, 2.0 Gy FX: Prophylactic cranial irradiation, 2.0 Gy once daily, M-F, in 18 fractions for a total of 36 Gy
572425|NCT00057746|E1|Reported Event|Arm I|Prophylactic cranial irradiation, 2.5 Gy FX: Prophylactic cranial irradiation, 2.5 Gy once daily, M-F, in 10 fractions for a total of 25 Gy
572426|NCT00057681|B4|Baseline|Total|Total of all reporting groups
572427|NCT00057681|B3|Baseline|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572428|NCT00057681|B2|Baseline|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572429|NCT00057681|B1|Baseline|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572430|NCT00057681|P3|Participant Flow|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572431|NCT00057681|P2|Participant Flow|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572432|NCT00057681|P1|Participant Flow|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572433|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572434|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572435|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572469|NCT00057330|B3|Baseline|Total|Total of all reporting groups
572470|NCT00057330|B2|Baseline|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572436|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572437|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572438|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572439|NCT00057681|O3|Outcome|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572440|NCT00057681|O2|Outcome|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572441|NCT00057681|O1|Outcome|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572442|NCT00057681|E3|Reported Event|Randomized Medication - Risperidone|Participants will receive treatment with risperidone for 8 to 16 weeks. At the initial dispensing visit, dose was 0.25mg qHS for 2 days, then 0.25mg BID for subjects <25kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects 25-50kg; 0.25mg BID for 2 days, then 0.5mg BID for subjects >50kg. Dose was adjusted at weeks 2-3 to 0.5mg BID for subjects <25kg, 1.0mg BID for subjects 25-50kg and >50kg. Dose was adjusted at weeks 4-5 to 1.0mg BID for subjects <25kg, 1.5mg BID for subjects 25-50kg, 2.0kg BID for subjects >50kg. Dose was adjusted at weeks 6-7 to 2.0mg BID for subjects <25kg, 2.0mg AM / 3.0mg PM for subjects 25-50kg, 3.0mg BID for subjects >50kg.
572443|NCT00057681|E2|Reported Event|Randomized Medication - Divalproex Sodium|Participants will receive treatment with divalproex sodium for 8 to 16 weeks. At the initial dispensing visit, dose was 125mg qHS for 2 days, then 125mg BID for subjects <25kg; 250mg qHS for 2 days, then 125mg AM / 250mg PM for subjects 25-50kg; 250mg qHS for 2 days, then 250mg BID for subjects >50kg. Dose was adjusted to achieve blood levels of 75 ug/ml at week 1, 100-110 ug/ml at weeks 2-3, and 111-125 ug/ml at weeks 4-7.
572444|NCT00057681|E1|Reported Event|Randomized Medication - Lithium|Participants will receive treatment with lithium for 8 to 16 weeks. At the initial dispensing visit, dose was 150mg qHS for 2 days, then 150mg BID for subjects <25kg; 150mg BID for 2 days, then 300mg BID for subjects 25-50kg; 300mg BID for 2 days, then 300mg AM / 600mg PM for subjects >50kg. Dose was adjusted to achieve blood levels of 0.8 mEq/L at week 1, 0.9-1.0 mEq/L at weeks 2-3, and 1.1-1.3 mEq/L at weeks 4-7.
572445|NCT00057577|B3|Baseline|Total|Total of all reporting groups
572446|NCT00057577|B2|Baseline|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572447|NCT00057577|B1|Baseline|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572448|NCT00057577|P2|Participant Flow|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572517|NCT00056563|B3|Baseline|Total|Total of all reporting groups
572449|NCT00057577|P1|Participant Flow|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 19 months. Remitted patients are continued on medication for up to 42 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572450|NCT00057577|O2|Outcome|Antidepressant Medications Only|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572451|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572452|NCT00057577|O2|Outcome|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572453|NCT00057577|O1|Outcome|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572454|NCT00057577|E2|Reported Event|Antidepressant Medications Alone|"Participants will receive maintenance of antidepressant medication alone~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572455|NCT00057577|E1|Reported Event|Cognitive Therapy Plus Antidepressant Medications|"Participants will receive antidepressant medication plus cognitive therapy~Cognitive Therapy (CT): CT sessions occur weekly during acute treatment and monthly during continuation. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from initial randomization until they meet criteria for recovery. At recovery, patients receiving combined treatment discontinue CT.~Antidepressant medications: Antidepressant medication is distributed as clinically indicated with augmentation and ancillary medications as needed. Acute treatment may last up to 18 months. Remitted patients are continued on medication for up to 36 months from the point of initial randomization until they meet criteria for recovery. All recovered patients are randomized a second time to either maintenance medication or medication withdrawal. Patients are then monitored over 36 months to ascertain risk for recurrence of depressive symptoms."
572456|NCT00057551|B4|Baseline|Total|Total of all reporting groups
572457|NCT00057551|B3|Baseline|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
572458|NCT00057551|B2|Baseline|Brief Supportive P|Brief Supportive Psychotherapyherapy
572459|NCT00057551|B1|Baseline|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
572460|NCT00057551|P3|Participant Flow|Medication Only|"An algorithm including Sertraline, Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
572461|NCT00057551|P2|Participant Flow|Brief Supportive Psychotherapy|Brief Supportive Psychotherapyherapy
572462|NCT00057551|P1|Participant Flow|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
572463|NCT00057551|O3|Outcome|Medication Only|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
572464|NCT00057551|O2|Outcome|Brief SP|Supportive Therapy
572465|NCT00057551|O1|Outcome|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
572466|NCT00057551|E3|Reported Event|Medication|"Sertraline~Escitalopram~Bupropion SR or XL~Venlafaxine XR~Mirtazapine"
572467|NCT00057551|E2|Reported Event|BriefSP|Supportive Therapy
572468|NCT00057551|E1|Reported Event|CBASP|Cognitive Behavioral Analysis System of Psychotherapy
572471|NCT00057330|B1|Baseline|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572472|NCT00057330|P2|Participant Flow|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572473|NCT00057330|P1|Participant Flow|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572474|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572475|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572476|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572477|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572478|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572479|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572480|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572481|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572482|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572483|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572484|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572485|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572486|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572487|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572488|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572489|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572490|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572491|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572492|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572493|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572494|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572495|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572496|NCT00057330|O2|Outcome|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572549|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
572497|NCT00057330|O1|Outcome|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572498|NCT00057330|E2|Reported Event|Havrix Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of the investigational formulation of Havrix vaccine intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572499|NCT00057330|E1|Reported Event|Herpes Simplex Virus Group|Females between, and including, 18 and 30 years of age at the time of first vaccination who received 3 doses of herpes simplex virus vaccine (HSV) intramuscularly in the non-dominant deltoid on a 0, 1, 6 month schedule.
572500|NCT00056862|B3|Baseline|Total|Total of all reporting groups
572501|NCT00056862|B2|Baseline|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572502|NCT00056862|B1|Baseline|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572503|NCT00056862|P2|Participant Flow|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572504|NCT00056862|P1|Participant Flow|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572505|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572506|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572507|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572508|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572509|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572510|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572511|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572512|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572513|NCT00056862|O2|Outcome|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572514|NCT00056862|O1|Outcome|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572515|NCT00056862|E2|Reported Event|Standard Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm B receives the standard, recommended dose of peginterferon (180 mcg per week) and standard, recommended dose of ribavirin for chronic hepatitis c, genotype 2 and 3.
572516|NCT00056862|E1|Reported Event|Low Dose Group|All patients receive peginterferon alfa-2a and ribavirin for 24 weeks with measurements of HCV RNA, routine liver tests, complete blood counts and side effects at regular intervals during therapy. Arm A receives a lower dose of peginterferon (90 mcg per week) but standard, recommended dose of ribavirin for chronic hepatitis C, genotype 2 and 3.
572518|NCT00056563|B2|Baseline|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
572519|NCT00056563|B1|Baseline|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
572520|NCT00056563|P2|Participant Flow|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
572521|NCT00056563|P1|Participant Flow|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
572522|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
572523|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
572524|NCT00056563|O2|Outcome|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of"
572525|NCT00056563|O1|Outcome|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
572526|NCT00056563|E2|Reported Event|2: Best Medical Therapy|"Best Medical Therapy~best medical therapy : Participants will initially be randomized to DBS or to 6 months of best medical therapy. BMT participants will then proceed into the surgical phase of the trial. Effective 08/05/05, randomization to the BMT arm has been discontinued since the study has sufficient information to compare the outcomes of DBS and BMT patients at 6 months."
572527|NCT00056563|E1|Reported Event|1: Bilateral Deep Brain Stimulation|"Bilateral Deep Brain Stimulation~Bilateral Deep Brain Stimulation : The DBS site (STN or GPi) will be assigned on a random basis at the time the patient enters the surgical phase of the trial."
572528|NCT00056550|B1|Baseline|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
572529|NCT00056550|P1|Participant Flow|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin(AT)deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with recombinant human antithrombin (rhAT) was individualized with an initial intravenous loading dose, followed by a continuous intravenous infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80% and <120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments were based on the results of AT activity level determinations performed prior to and during the treatment.
572530|NCT00056550|O1|Outcome|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal.
572531|NCT00056550|O1|Outcome|Recombinant Human Antithombin (rhAT) Infusion|Following a baseline evaluation phase hereditary antithrombin (AT) deficient patients scheduled for surgery, cesarean section or vaginal delivery were planned to be treated prophylactically with recombinant human antithrombin (rhAT). Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to target and maintain antithrombin (AT) activity levels > 80% and < 120% of normal. The dosing objective for all study patients is maintenance of the AT activity at >80 and < 120% of normal during the high risk period for thromboembolic events. Dosing and dose adjustments will be based on the results of AT activity determinations performed prior to and during treatment.
572532|NCT00056550|E1|Reported Event|Recombinant Human Antithrombin (rhAT) Infusion|Following a baseline evaluation phase hereditary AT deficient patients(previously documented AT activity < or equal to 60% of normal)scheduled for surgery ,cesarean section or vaginal delivery were planned to be treated prophylactically with rhAT. Dosing with rhAT was to be individualized with an initial loading dose, followed by a continuous maintenance infusion dose, intended to increase and target antithrombin (AT) activity levels > 80% and < 120% of normal.
572533|NCT00056498|B3|Baseline|Total|Total of all reporting groups
572534|NCT00056498|B2|Baseline|Placebo|Participants assigned to placebo
572535|NCT00056498|B1|Baseline|Risperidone|Participants assigned to risperidone
572536|NCT00056498|P2|Participant Flow|Placebo|Participants assigned to placebo
572537|NCT00056498|P1|Participant Flow|Risperidone|Participants assigned to risperidone
572538|NCT00056498|O2|Outcome|Placebo|Participants assigned to placebo
572539|NCT00056498|O1|Outcome|Risperidone|Participants assigned to risperidone
572540|NCT00056498|E2|Reported Event|Placebo|Participants assigned to placebo
572541|NCT00056498|E1|Reported Event|Risperidone|Participants assigned to risperidone
572542|NCT00056472|B3|Baseline|Total|Total of all reporting groups
572543|NCT00056472|B2|Baseline|Monotherapy|placebo plus olanzapine
572544|NCT00056472|B1|Baseline|Pharmacotherapy|sertraline plus olanzapine
572545|NCT00056472|P2|Participant Flow|Olanzapine Plus Placebo|5-20mg/day olanzapine plus placebo
572546|NCT00056472|P1|Participant Flow|Sertraline Plus Olanzapine|50-200mg/day sertraline plus 5-20mg/day olanzapine
572547|NCT00056472|O2|Outcome|Monotherapy|placebo plus olanzapine
572548|NCT00056472|O1|Outcome|Pharmacotherapy|sertraline plus olanzapine
572556|NCT00056407|B2|Baseline|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572557|NCT00056407|B1|Baseline|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572558|NCT00056407|P2|Participant Flow|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572559|NCT00056407|P1|Participant Flow|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572560|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572561|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572562|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572563|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572564|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572565|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572566|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572567|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572568|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572569|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572570|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572571|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572572|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572573|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572574|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572575|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572576|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572577|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572578|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572579|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572580|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572581|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572582|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572583|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572584|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572585|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572586|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572587|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572588|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572589|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572590|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572591|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572592|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572593|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572594|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572595|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572596|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572597|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572598|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572599|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572600|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572601|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572602|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572603|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572604|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572605|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572606|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572607|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572608|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572609|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572610|NCT00056407|O2|Outcome|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572611|NCT00056407|O1|Outcome|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572612|NCT00056407|E2|Reported Event|Dutasteride 0.5 mg|Dutasteride 0.5 milligrams (mg), repeat oral once daily dosing for 4 years. Dutasteride supplied as gelatin capsule.
572613|NCT00056407|E1|Reported Event|Placebo|Placebo, repeat oral once daily dosing for 4 years. Placebo supplied as matching dutasteride capsules.
572614|NCT00056316|B3|Baseline|Total|Total of all reporting groups
572615|NCT00056316|B2|Baseline|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572616|NCT00056316|B1|Baseline|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572617|NCT00056316|P2|Participant Flow|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572618|NCT00056316|P1|Participant Flow|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572619|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572620|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572621|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572622|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572623|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572624|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572625|NCT00056316|O2|Outcome|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572626|NCT00056316|O1|Outcome|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572627|NCT00056316|E2|Reported Event|Basic Education|Participants receive 37-page Basic Care Guide (Education Institute, 2001) and bi-weekly telephone calls by a trained staff member.
572628|NCT00056316|E1|Reported Event|Behavioral Skills Training|Multicomponent behavioral intervention using 10-session video series (Steffen, et al., 2001) workbook (Steffen, et al., 2001), and weekly telephone coaching sessions.
572629|NCT00056160|B3|Baseline|Total|Total of all reporting groups
572630|NCT00056160|B2|Baseline|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572631|NCT00056160|B1|Baseline|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572632|NCT00056160|P2|Participant Flow|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572633|NCT00056160|P1|Participant Flow|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572634|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572635|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572636|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572637|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572638|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572639|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572640|NCT00056160|O2|Outcome|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572641|NCT00056160|O1|Outcome|CC-5013/Dex|CC-5013 (lenalidomide) plus oral high-dose dexamethasone
572642|NCT00056160|E2|Reported Event|Placebo/Dex|Placebo, identical in appearance to CC-5013 (lenalidomide), plus oral high-dose dexamethasone
572644|NCT00055692|B1|Baseline|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572645|NCT00055692|P1|Participant Flow|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572646|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572647|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572648|NCT00055692|O2|Outcome|Treatment (Bevacizumab): 8 Weeks|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572649|NCT00055692|O1|Outcome|Treatment (Bevacizumab): Baseline|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572650|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572651|NCT00055692|O1|Outcome|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572652|NCT00055692|E1|Reported Event|Treatment (Bevacizumab)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment continues every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given orally"
572653|NCT00055601|B3|Baseline|Total|Total of all reporting groups
572654|NCT00055601|B2|Baseline|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572655|NCT00055601|B1|Baseline|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572656|NCT00055601|P2|Participant Flow|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572657|NCT00055601|P1|Participant Flow|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572658|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572659|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572660|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572661|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572662|NCT00055601|O2|Outcome|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572663|NCT00055601|O1|Outcome|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572664|NCT00055601|E2|Reported Event|Pelvic RT + Fluorouracil + Cisplatin|Induction: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with fluoruracil and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572665|NCT00055601|E1|Reported Event|Pelvic RT + Paclitaxel + Cisplatin|Induction: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin; Consolidation: Twice-daily pelvic radiation therapy with paclitaxel and cisplatin if tumor response is T0/Ta/Tis or radical cystectomy if tumor response is ≥ T1; Adjuvant: gemcitabine, paclitaxel, and cisplatin IV.
572666|NCT00055497|B5|Baseline|Total|Total of all reporting groups
572667|NCT00055497|B4|Baseline|OL Adalimumab 40 mg Eow|Participants who did not continue at Week 4 are not included in Baseline summary.
572668|NCT00055497|B3|Baseline|DB Adalimumab 40 mg Every Week|
572669|NCT00055497|B2|Baseline|DB Adalimumab 40 mg Every Other Week (Eow)|
572670|NCT00055497|B1|Baseline|DB Placebo|
572671|NCT00055497|P4|Participant Flow|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week.
572672|NCT00055497|P3|Participant Flow|DB Adalimumab 40 mg Every Week (ew)|Double-blind adalimumab 40 mg every week.
572673|NCT00055497|P2|Participant Flow|DB Adalimumab 40 mg Every Other Week (Eow)|Double-blind adalimumab 40 mg every other week (injection received every week; placebo received when active drug not received)
572674|NCT00055497|P1|Participant Flow|DB Placebo|Double-blind adalimumab placebo every week.
572675|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572676|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572677|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572678|NCT00055497|O1|Outcome|DB Placebo|
572679|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572680|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572681|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572682|NCT00055497|O1|Outcome|DB Placebo|
572683|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572684|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572685|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572686|NCT00055497|O1|Outcome|DB Placebo|
572687|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|
572688|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572689|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572690|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572691|NCT00055497|O1|Outcome|DB Placebo|
572692|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572693|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
572694|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
572695|NCT00055497|O1|Outcome|DB Placebo|
572696|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572697|NCT00055497|O3|Outcome|DB Adalimumab 40 mg ew|
572698|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Eow|
572699|NCT00055497|O1|Outcome|DB Placebo|
572700|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572701|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572702|NCT00055497|O1|Outcome|DB Placebo|
572703|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572704|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572705|NCT00055497|O1|Outcome|Placebo|
572706|NCT00055497|O1|Outcome|OL Adalimumab 40 mg|Open-label adalimumab 40 mg every other week or every week
572707|NCT00055497|O4|Outcome|OL Adalimumab 40 mg Eow|
572708|NCT00055497|O3|Outcome|DB Adalimumab 40 mg Every Week (ew)|
572709|NCT00055497|O2|Outcome|DB Adalimumab 40 mg Every Other Week (Eow)|
572710|NCT00055497|O1|Outcome|DB Placebo|
572711|NCT00055497|E4|Reported Event|OL Adalimumab 40 mg|
572712|NCT00055497|E3|Reported Event|DB Adalimumab 40 mg ew|
572713|NCT00055497|E2|Reported Event|DB Adalimumab 40 mg Eow|
572714|NCT00055497|E1|Reported Event|DB Placebo|
572715|NCT00055471|B4|Baseline|Total|Total of all reporting groups
572716|NCT00055471|B3|Baseline|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572717|NCT00055471|B2|Baseline|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572718|NCT00055471|B1|Baseline|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572719|NCT00055471|P3|Participant Flow|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572720|NCT00055471|P2|Participant Flow|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572721|NCT00055471|P1|Participant Flow|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572722|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572723|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572724|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572725|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572726|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572727|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572728|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572729|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572730|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572731|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572732|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572733|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572734|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572735|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572736|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572737|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572738|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572739|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572740|NCT00055471|O3|Outcome|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572741|NCT00055471|O2|Outcome|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572742|NCT00055471|O1|Outcome|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572743|NCT00055471|E3|Reported Event|ZD4054 22.5 mg|ZD4054 22.5 mg dose: 2 x 10 mg + 1 x 2.5 mg oral tablets once daily
572744|NCT00055471|E2|Reported Event|ZD4054 15 mg|ZD4054 15 mg dose: 1 x 10 mg + 2 x 2.5 mg oral tablets once daily
572745|NCT00055471|E1|Reported Event|ZD4054 10 mg|ZD4054 10 mg dose: 1 x 10 mg oral tablet once daily
572746|NCT00055237|B3|Baseline|Total|Total of all reporting groups
572747|NCT00055237|B2|Baseline|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572748|NCT00055237|B1|Baseline|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572749|NCT00055237|P2|Participant Flow|Cohort 2: Pts With Classic Kaposi's Sarcoma (HIV-uninfected)|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572750|NCT00055237|P1|Participant Flow|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572751|NCT00055237|O1|Outcome|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572752|NCT00055237|O1|Outcome|Cohort 1: Cohort 1: Pts With HIV-associated Kaposi's Sarcoma|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572753|NCT00055237|E1|Reported Event|Cohort 1 & 2: Pts With HIV-associated and Classic KS|15 mg/kg bevacizumab intravenously on days 1 and 8 then every 3 weeks
572754|NCT00054847|B3|Baseline|Total|Total of all reporting groups
572755|NCT00054847|B2|Baseline|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
572756|NCT00054847|B1|Baseline|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
572757|NCT00054847|P2|Participant Flow|Radial Artery Graft|"Radial Artery Graft~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
572758|NCT00054847|P1|Participant Flow|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
572759|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
572760|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
572761|NCT00054847|O2|Outcome|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
572762|NCT00054847|O1|Outcome|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
572763|NCT00054847|O2|Outcome|Radial Artery Grafts|"Radial Artery Grafts~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
572764|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
572765|NCT00054847|O2|Outcome|Radial Artery Graft|"Radial Artery~radial artery graft : Radial artery harvested from the arm is used as a conduit for CABG."
572766|NCT00054847|O1|Outcome|Saphenous Vein Graft|"Saphenous Vein Graft~saphenous vein graft : Saphenous vein harvested from the arm is used as a conduit for CABG."
572767|NCT00054847|E2|Reported Event|Arm 2|"Radial Artery~radial artery graft: Radial artery harvested from the arm is used as a conduit for CABG."
572768|NCT00054847|E1|Reported Event|Arm 1|"Saphenous Vein Graft~saphenous vein graft: Saphenous vein harvested from the arm is used as a conduit for CABG."
572769|NCT00054717|B3|Baseline|Total|Total of all reporting groups
572770|NCT00054717|B2|Baseline|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572771|NCT00054717|B1|Baseline|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572772|NCT00054717|P2|Participant Flow|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572773|NCT00054717|P1|Participant Flow|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572774|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572775|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572776|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572777|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572778|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572779|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572780|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572781|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572782|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572783|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572784|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572785|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572786|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572787|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572788|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572789|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572790|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572791|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572792|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572793|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572794|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572795|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572796|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572797|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572798|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572799|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572800|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572801|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572802|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572803|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572804|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572805|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572806|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572807|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572808|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572809|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572810|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572811|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572812|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572813|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572814|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572815|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572816|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572817|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572818|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572819|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572820|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572821|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572822|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572823|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572824|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572825|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572826|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572827|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572828|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572829|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572830|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572831|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572832|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572833|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
573072|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
572834|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572835|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572836|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572837|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572838|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572839|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572840|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572841|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572842|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572843|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572844|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572845|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572846|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572847|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572848|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572849|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572850|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572851|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572852|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572853|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572854|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572855|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572856|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572857|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572858|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572859|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572860|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572861|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572862|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572863|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572864|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572865|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572866|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572867|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572868|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572869|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572870|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572871|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572872|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572873|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572874|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572875|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572876|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572877|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572878|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572879|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572880|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572881|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572882|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572883|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572884|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572885|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572886|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572887|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572888|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572889|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572890|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572891|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572892|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572893|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572894|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572895|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572896|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572897|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572898|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572899|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572900|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572901|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572902|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572903|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572904|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572905|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572906|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572907|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572908|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572909|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572910|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572911|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572912|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572913|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572914|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572915|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572916|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572917|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572918|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572919|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
573073|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
572920|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572921|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572922|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572923|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572924|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572925|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572926|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572927|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572928|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572929|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572930|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572931|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572932|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572933|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572934|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572935|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572936|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572937|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572938|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572939|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572940|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572941|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572942|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572943|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572944|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572945|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572946|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572947|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572948|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572949|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572950|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572951|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572952|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572953|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572954|NCT00054717|O2|Outcome|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572955|NCT00054717|O1|Outcome|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572956|NCT00054717|E2|Reported Event|Comparitor Protease Inhibitor(CPR)/Low Dose Ritonavir(r)|lopinavir, amprenavir [or fosamprenavir], saquinavir or indinavir combined with low-dose (100-200 mg) Ritonavir (RTV)
572957|NCT00054717|E1|Reported Event|Tipranavir(TPV)/Low Dose Ritonavir(r)|TPV 500 mg / Ritonavir 200 mg, twice daily
572958|NCT00054704|B3|Baseline|Total|Total of all reporting groups
572959|NCT00054704|B2|Baseline|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572960|NCT00054704|B1|Baseline|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572961|NCT00054704|P2|Participant Flow|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572962|NCT00054704|P1|Participant Flow|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572963|NCT00054704|O2|Outcome|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572964|NCT00054704|O1|Outcome|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572965|NCT00054704|E2|Reported Event|Placebo|Placebo pills resembling 50 mg riluzole tables were dispensed either once or twice a day. Dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572966|NCT00054704|E1|Reported Event|Riluzole|Riluzole was dispensed either once or twice a day as 50 mg tablets. Riluzole dosing began at 50 mg twice per day by mouth and was increased on a weekly basis by 50 mg, as tolerated, to achieve a dose of 200 mg/day. Dose escalations continued until at least a 50% reduction in depression (MADRS) scores, intolerable side effects, or study completion. Dose was raised on a weekly basis by 50 mg until the dose of 200 mg was achieved unless precluded by an adverse event. If significant side effects occurred, titration was slowed and doses were reduced under double-blind conditions. The maximum permitted dose of riluzole was be 200 mg/day. Those subjects not tolerating a dosage of 50 mg/day were removed from the study.
572967|NCT00054691|B1|Baseline|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
572968|NCT00054691|P1|Participant Flow|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
572969|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
572970|NCT00054691|O1|Outcome|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
572971|NCT00054691|E1|Reported Event|Iressa (ZD1839)|250 mg by mouth daily (1 course = 4 weeks), 6 courses of treatment.
572972|NCT00054665|B1|Baseline|Arm A & B: PS-341 and PS-341 & EPOCH|"Part A: PS-341 Alone~1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks Part B: PS-341 & EPOCH~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days"
572973|NCT00054665|P2|Participant Flow|Part B: PS-341 & EPOCH|PS-341 1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks. EPOCH (etoposide 50 mg/m^2 day continuous intravenous infusion days 1-4, doxorubicin 10 mg/m^2 day continuous intravenous infusion days 1-4, vincristine 0.4 mg/m^2/day continuous intravenous infusion days 1-4, cyclophosphamide 750 mg/m^2 intravenous bolus day 5, prednisone 60 mg/m^2 by mouth days 1-5, and filgrastim 300 micrograms subcutaneously day 6 to absolute neutrophil count (ANC) recovery >/= 5000/mm^3.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
573074|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
572974|NCT00054665|P1|Participant Flow|Part A: PS-341 Alone|1.3 mg/m^2 intravenous bolus injection over 3-5 seconds every 3 weeks.Per the protocol, patients who require an immediate treatment response for medical reasons will only receive part B of the protocol. This decision will be made by the principal investigator in consultation with the associate investigators.
572975|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"Part B:~PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
572976|NCT00054665|O1|Outcome|Part A: PS-341 Alone|Part A: 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
572977|NCT00054665|O2|Outcome|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycle every 21 days."
572978|NCT00054665|O1|Outcome|Part A: PS-341 Alone|1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
572979|NCT00054665|E2|Reported Event|Part B: PS-341 & EPOCH|"PS-341: level 1: 0.5 mg/m^2 intravenous (IV) days 1, 4; level 2: 1.0 mg/m^2 IV days 1, 4; level 3: 1.5 mg/m^2 IV days 1, 4; level 4: 1.7 mg/m^2 IV days 1, 4.~EPOCH: Etoposide: 50 mg/m^2 day continuous intravenous infusion (CIV) days 1-4, 96 hour infusion; Doxorubicin: 10 mg/m^2 day CIV days 1-4, 96 hour infusion; Vincristine: 0.4 mg/m^2 day CIV days 1-4, 96 hour infusion; Cyclophosphamide: 750 mg/m^2 day IV day 5 bolus; Prednisone: 60 mg/m^2 by mouth twice a day days 1-5; Filgrastim: 300 micrograms subcutaneously days 6 to absolute neutrophil count recovery greater than or equal to 5000/mm^3. Repeat cycles every 21 days."
572980|NCT00054665|E1|Reported Event|Part A: PS-341 Alone|PS-341 1.3 mg/m^2 intravenous injection days 1, 4, 8, 11 every 3 weeks
572981|NCT00054639|B1|Baseline|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
572982|NCT00054639|P1|Participant Flow|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
572983|NCT00054639|O1|Outcome|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
572984|NCT00054639|E1|Reported Event|Oblimersen + Rituximab|Oblimersen 3 mg/kg/day continuous intravenous infusion daily for 7 days on alternated weeks on week 1, 3 and 5 (days 1 through 7, 15 through 21, and 29 through 35); Rituximab 375 mg/m2 intravenous infusion for six doses on days 3, 8,15, 22, 29, and 36.
572985|NCT00054327|B7|Baseline|Total|Total of all reporting groups
572986|NCT00054327|B6|Baseline|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
572987|NCT00054327|B5|Baseline|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
572988|NCT00054327|B4|Baseline|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
572989|NCT00054327|B3|Baseline|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
572990|NCT00054327|B2|Baseline|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY.
572991|NCT00054327|B1|Baseline|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
572992|NCT00054327|P6|Participant Flow|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
572993|NCT00054327|P5|Participant Flow|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
572994|NCT00054327|P4|Participant Flow|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
572995|NCT00054327|P3|Participant Flow|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
572996|NCT00054327|P2|Participant Flow|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
572997|NCT00054327|P1|Participant Flow|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
572998|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
572999|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573075|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573000|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573001|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573002|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573003|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573004|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
573005|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573006|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573007|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573008|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573009|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573010|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
573011|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573012|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573013|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573014|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573015|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573016|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
573017|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573018|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573019|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573020|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573021|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573022|NCT00054327|O6|Outcome|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
573023|NCT00054327|O5|Outcome|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573024|NCT00054327|O4|Outcome|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573025|NCT00054327|O3|Outcome|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573026|NCT00054327|O2|Outcome|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573027|NCT00054327|O1|Outcome|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573028|NCT00054327|E6|Reported Event|Regimen D|Patients receive total body irradiation (TBI) on days T -6, -5 and -4 for a total of 1320 cGy , then etoposide (60mg/kg/dose) on day -3.
573029|NCT00054327|E5|Reported Event|Regimen C|Patients receive oral busulfan 1mg/kg/dose (or 40mg/m2/dose for young children)4 times daily on days -8 to -5 and cyclophosphamide 60 mg/kg IV over 2 hours on days -4 to -2.
573030|NCT00054327|E4|Reported Event|Regimen B-3|Patients undergo total body irradiation (TBI) twice daily on days -7 to -5 for a total of 1200 cGY. Patients then receive cyclophosphamide 60 mg/kg IV on days -4 and -3.
573031|NCT00054327|E3|Reported Event|Regimen B-2|Patients receive cyclophosphamide 60 mg/kg IV over 2 hours on days -5 and -4. Patients also undergo TBI twice daily on days -3 to -1 for a total of 1200 cGY.
573032|NCT00054327|E2|Reported Event|Regimen B-1|Patients receive cyclophosphamide 60 mg/kg IV on days -6 and -5. Patients also undergo total body irradiation (TBI) twice daily on days -4 to -1 for a total of 1320 cGY..
573033|NCT00054327|E1|Reported Event|Regimen A|Patients receive cytarabine 3.0gm/M² IV over 1 hour twice daily on days -9 to -7 and cyclophosphamide 45mg/kg IV over 2 hours on days -6 and -5. Patients also undergo total body irradiation (TBI), 165 cGY, twice daily on days -4 to -1 for a total of 1320 cGY.
573034|NCT00054275|B1|Baseline|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573035|NCT00054275|P1|Participant Flow|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573036|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573037|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573038|NCT00054275|O1|Outcome|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573039|NCT00054275|E1|Reported Event|Docetaxel and OSI-774|docetaxel IV over 1 hour once weekly for 3 weeks and oral erlotinib once daily
573040|NCT00054028|B3|Baseline|Total|Total of all reporting groups
573041|NCT00054028|B2|Baseline|Suramin and Paclitaxel (Phase II)|Patients receive paclitaxel in combination with the target dose of suramin.
573042|NCT00054028|B1|Baseline|Suramin and Paclitaxel (Phase I)|Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.
573043|NCT00054028|P1|Participant Flow|Treatment (Suramin and Paclitaxel)|"PHASE I: Patients receive low-dose suramin IV over 30 minutes and paclitaxel IV over 1 hour once weekly. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive adjusted doses of suramin until a target dose is determined. The suramin target dose is defined as the dose at which at least 5 of 6 patients achieve the target plasma concentration of 10-50 uM over the duration when paclitaxel levels are therapeutic.~PHASE II: Patients receive paclitaxel in combination with the target dose of suramin as above."
573044|NCT00054028|O1|Outcome|Treatment (Suramin and Paclitaxel)|PHASE II: Patients receive paclitaxel in combination with the target dose of suramin the same as Phase I.
573045|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
573046|NCT00054028|O1|Outcome|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
573047|NCT00054028|E1|Reported Event|Suramin and Paclitaxel|Suramin will be infused weekly over 30 minutes. Four hours after the completion of the suramin infusion the 1 hour infusion of paclitaxel will begin.
573048|NCT00053846|B3|Baseline|Total|Total of all reporting groups
573049|NCT00053846|B2|Baseline|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
573050|NCT00053846|B1|Baseline|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
573051|NCT00053846|P2|Participant Flow|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
573052|NCT00053846|P1|Participant Flow|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
573053|NCT00053846|O2|Outcome|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
573054|NCT00053846|O1|Outcome|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
573055|NCT00053846|E2|Reported Event|Placebo|Treatment with placebo will be one tablet taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the study period.
573056|NCT00053846|E1|Reported Event|Buspirone Hydrochloride|buspirone hydrochloride: The dose of buspirone will be 10 mg taken by mouth at bedtime for 3 days, then twice each day, in the morning and at bedtime for the remainder of the 28 day study period
573057|NCT00053703|B4|Baseline|Total|Total of all reporting groups
573058|NCT00053703|B3|Baseline|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573059|NCT00053703|B2|Baseline|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573060|NCT00053703|B1|Baseline|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573061|NCT00053703|P3|Participant Flow|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573062|NCT00053703|P2|Participant Flow|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573063|NCT00053703|P1|Participant Flow|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573064|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573065|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573066|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573067|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573068|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573069|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573070|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573071|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573076|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573077|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573078|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573079|NCT00053703|O3|Outcome|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573080|NCT00053703|O2|Outcome|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573081|NCT00053703|O1|Outcome|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573082|NCT00053703|E3|Reported Event|Molindone|oral molindone from 10-140mg/daily for up to 52 weeks
573083|NCT00053703|E2|Reported Event|Risperidone|oral risperidone 0.5mg to 6mg daily for up to 52 weeks
573084|NCT00053703|E1|Reported Event|Olanzapine|oral olanzapine 5-20mg per day for up to 52 weeks
573085|NCT00053495|B6|Baseline|Total|Total of all reporting groups
573086|NCT00053495|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573087|NCT00053495|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573088|NCT00053495|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573089|NCT00053495|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573090|NCT00053495|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573091|NCT00053495|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573092|NCT00053495|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573093|NCT00053495|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573094|NCT00053495|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573095|NCT00053495|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573096|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573097|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573098|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573099|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573100|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573101|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573102|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573103|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573104|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573105|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573106|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573107|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573108|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573109|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573110|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573111|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573112|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573113|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573114|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573115|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573116|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573117|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573118|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573119|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573120|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573121|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
574520|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
573122|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573123|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573124|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573125|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573126|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573127|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573128|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573129|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573130|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573131|NCT00053495|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573132|NCT00053495|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573133|NCT00053495|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573134|NCT00053495|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573135|NCT00053495|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573136|NCT00053495|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573137|NCT00053495|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10^6th plaque-forming units/mL on Day 0
573138|NCT00053495|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^7th plaque-forming units/mL on Day 0
573139|NCT00053495|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10^8th plaque-forming units/mL on Day 0
573140|NCT00053495|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10^8th plaque-forming units/mL on Day 0
573141|NCT00053482|B6|Baseline|Total|Total of all reporting groups
573142|NCT00053482|B5|Baseline|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573143|NCT00053482|B4|Baseline|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573144|NCT00053482|B3|Baseline|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573145|NCT00053482|B2|Baseline|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573146|NCT00053482|B1|Baseline|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573147|NCT00053482|P5|Participant Flow|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573148|NCT00053482|P4|Participant Flow|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573149|NCT00053482|P3|Participant Flow|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573150|NCT00053482|P2|Participant Flow|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573151|NCT00053482|P1|Participant Flow|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573152|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573153|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573154|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573155|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573156|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573157|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573158|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573159|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573160|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573161|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573162|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573163|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573164|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
574521|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
573165|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573166|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573167|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573168|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573169|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573170|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573171|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573172|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573173|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573174|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573175|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573176|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573177|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573178|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573179|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573180|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573181|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573182|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573183|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573184|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573185|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573186|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573187|NCT00053482|O5|Outcome|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573188|NCT00053482|O4|Outcome|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573189|NCT00053482|O3|Outcome|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573190|NCT00053482|O2|Outcome|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573191|NCT00053482|O1|Outcome|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573192|NCT00053482|E5|Reported Event|Dryvax® Vaccine|Participants received a single dose of Dryvax® smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573193|NCT00053482|E4|Reported Event|ACAM2000 Dose 4|Participants received a single dose of ACAM2000 smallpox vaccine, 5.0x10-6th plaque-forming units/mL on Day 0
573194|NCT00053482|E3|Reported Event|ACAM2000 Dose 3|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-7th plaque-forming units/mL on Day 0
573195|NCT00053482|E2|Reported Event|ACAM2000 Dose 2|Participants received a single dose of ACAM2000 smallpox vaccine, 2.0x10-7th plaque-forming units/mL on Day 0
573196|NCT00053482|E1|Reported Event|ACAM2000 Dose 1|Participants received a single dose of ACAM2000 smallpox vaccine, 1.0x10-8th plaque-forming units/mL on Day 0
573197|NCT00053417|B5|Baseline|Total|Total of all reporting groups
573198|NCT00053417|B4|Baseline|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
573199|NCT00053417|B3|Baseline|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
573200|NCT00053417|B2|Baseline|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
573201|NCT00053417|B1|Baseline|Placebo|Placebo control
573202|NCT00053417|P4|Participant Flow|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
573203|NCT00053417|P3|Participant Flow|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
573204|NCT00053417|P2|Participant Flow|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
573205|NCT00053417|P1|Participant Flow|Placebo|Placebo control
573206|NCT00053417|O4|Outcome|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
573207|NCT00053417|O3|Outcome|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
573208|NCT00053417|O2|Outcome|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
573209|NCT00053417|O1|Outcome|Placebo|Placebo control
573210|NCT00053417|E4|Reported Event|20 mg Fampridine b.i.d.|fampridine, oral, 20 mg administered twice daily
573211|NCT00053417|E3|Reported Event|15 mg Fampridine b.i.d.|fampridine, oral, 15 mg administered twice daily
573212|NCT00053417|E2|Reported Event|10 mg Fampridine Twice a Day (b.i.d.)|fampridine, oral, 10 mg administered twice daily
573213|NCT00053417|E1|Reported Event|Placebo|Placebo control
573214|NCT00053365|B1|Baseline|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
573215|NCT00053365|P1|Participant Flow|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
573216|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
573217|NCT00053365|O1|Outcome|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
573218|NCT00053365|E1|Reported Event|Treatment (Irofulven)|Patients receive irofulven IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of unacceptable toxicity or disease progression.
573219|NCT00053014|B1|Baseline|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
573220|NCT00053014|P1|Participant Flow|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
573221|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
573222|NCT00053014|O1|Outcome|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
573223|NCT00053014|E1|Reported Event|Treatment|patient conditioning - fludarabine 30 mg/m2 IV over 1 hour Days -4, -3, -2; TBI 6-7 cGy/min Day 0 post-transplant immunosuppression - CSP 6.25 mg/kg bid PO D -3 to +180 (begin taper on D+35); MMF 15mg/kg bid PO D0 to +27
573224|NCT00052962|B3|Baseline|Total|Total of all reporting groups
573225|NCT00052962|B2|Baseline|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573226|NCT00052962|B1|Baseline|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573227|NCT00052962|P2|Participant Flow|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573228|NCT00052962|P1|Participant Flow|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573229|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573230|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573231|NCT00052962|O2|Outcome|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573232|NCT00052962|O1|Outcome|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573233|NCT00052962|E2|Reported Event|Arm 2 Surgery + CHPP|"Arm 2 Surgery + Continuous hyperthermic peritoneal perfusion (CHPP) + post op dwell + post op chemotherapy~Cytoreductive surgery~continuous hyperthermic peritoneal perfusion (CHPP) with 250 mg/m^2 cisplatin~post operative dwell chemotherapy given once between post op day 7 and 12: 5-fluorouracil (5FU) 800 mg/m^2 and paclitaxel 125 mg/m^2~post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-FU, every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573234|NCT00052962|E1|Reported Event|Arm 1 Surgery + Post op Chemotherapy|"Cytoreductive surgery~Post operative chemotherapy: systemic oxaliplatin, leucovorin and infusional 5-fluorouracil (5-FU), every other week of every four weeks (two weeks per month) starting 4 to 6 weeks after operation and continuing for four cycles {16 weeks total}."
573320|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573235|NCT00052429|B1|Baseline|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
573236|NCT00052429|P1|Participant Flow|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
573237|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
573238|NCT00052429|O1|Outcome|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
573239|NCT00052429|E1|Reported Event|High-Dose Radiation Therapy Plus Chemotherapy|"Phase I~Radiotherapy: Patients receive radiotherapy once daily 5 days a week for 6 weeks beginning on day 1.~Concurrent chemotherapy: Patients receive cisplatin IV over 20-30 minutes on days 1-5 and 22-26.~Adjuvant chemotherapy: Approximately 2-5 weeks after the completion of radiotherapy, patients receive fluorouracil IV continuously on days 1-4 and cisplatin IV over 20-30 minutes on days 1-5 and 22-26. Treatment repeats every 28 days for 3 courses in the absence of disease progression or unacceptable toxicity. In the absence of dose-limiting toxicity in 1 whole cohort of patients, study proceeds to phase II. Phase II~Patients are treated as in phase I. Patients are followed every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter."
573240|NCT00051636|B3|Baseline|Total|Total of all reporting groups
573241|NCT00051636|B2|Baseline|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573242|NCT00051636|B1|Baseline|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573243|NCT00051636|P2|Participant Flow|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573244|NCT00051636|P1|Participant Flow|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573245|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573246|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573247|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573248|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573322|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573249|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573250|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573251|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573252|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573253|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573254|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573255|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573256|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573257|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573258|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573259|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573260|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573261|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573262|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573263|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573264|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573265|NCT00051636|O2|Outcome|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573266|NCT00051636|O1|Outcome|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573267|NCT00051636|E2|Reported Event|Risedronate and Placebo to Zoledronic Acid|Participants received 60 days of oral risedronate 30 mg, one intravenous infusion of placebo to zoledronic acid, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573321|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573268|NCT00051636|E1|Reported Event|Zoledronic Acid and Placebo to Risedronate|Participants received zoledronic acid 5 mg intravenous infusion one dose, 60 days of oral placebo to risedronate, calcium 500 mg twice a day and vitamin D 400 to 1000 international units daily during the core period, and received only calcium and vitamin D supplements during the extended observation period.
573269|NCT00051558|B3|Baseline|Total|Total of all reporting groups
573270|NCT00051558|B2|Baseline|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573271|NCT00051558|B1|Baseline|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573272|NCT00051558|P2|Participant Flow|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573273|NCT00051558|P1|Participant Flow|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573274|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573275|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573276|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573277|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573278|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573279|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573280|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573281|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573282|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573283|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573284|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573285|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573286|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573287|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573288|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573289|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573290|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573291|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573292|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573293|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573294|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573295|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573296|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573297|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573298|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573299|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573300|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573301|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573302|NCT00051558|O2|Outcome|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573303|NCT00051558|O1|Outcome|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573304|NCT00051558|E2|Reported Event|Alendronate|Alendronate 10 mg/day oral plus injection placebo, 36 months
573305|NCT00051558|E1|Reported Event|Teriparatide|Teriparatide 20 micrograms/day injection plus oral placebo, 36 months
573306|NCT00051363|B3|Baseline|Total|Total of all reporting groups
573307|NCT00051363|B2|Baseline|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573308|NCT00051363|B1|Baseline|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573309|NCT00051363|P2|Participant Flow|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573310|NCT00051363|P1|Participant Flow|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573311|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573312|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573313|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573314|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573315|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573316|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573317|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573318|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573319|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573323|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573324|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573325|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573326|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573327|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573328|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573329|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573330|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573331|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573332|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573333|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573334|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573335|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573336|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573337|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573338|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573339|NCT00051363|O2|Outcome|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573340|NCT00051363|O1|Outcome|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573341|NCT00051363|E2|Reported Event|Sham CPAP|Sham Continuous Positive Airway Pressure (CPAP) has been modified to be sub-therapeutic, yet closely simulates an Active CPAP device.
573342|NCT00051363|E1|Reported Event|Active CPAP|Active Continuous Positive Airway Pressure (CPAP) is widely used for the treatment of Obstructive Sleep Apnea (OSA)
573343|NCT00051168|B1|Baseline|Travatan|Travoprost (0.004%)
573344|NCT00051168|P1|Participant Flow|Travatan|Travoprost (0.004%)
573345|NCT00051168|O1|Outcome|Travatan|Travoprost (0.004%)
573346|NCT00051168|E1|Reported Event|Travatan|Travoprost (0.004%)
573347|NCT00050167|B3|Baseline|Total|Total of all reporting groups
573348|NCT00050167|B2|Baseline|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
573349|NCT00050167|B1|Baseline|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
573350|NCT00050167|P2|Participant Flow|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
573351|NCT00050167|P1|Participant Flow|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
573352|NCT00050167|O2|Outcome|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
573353|NCT00050167|O1|Outcome|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
573354|NCT00050167|E2|Reported Event|Docetaxel and Capecitabine (DX)|Docetaxel + Capecitabine days 1-14 every 3 weeks for 4 cycles followed by FEC for 4 cycles.
573355|NCT00050167|E1|Reported Event|Weekly Paclitaxel (WP)|Weekly Paclitaxel for 12 weeks followed by Fluorouracil + Epirubicin + Cyclophosphamide (FEC) every 3 weeks for 4 cycles
573356|NCT00051025|B3|Baseline|Total|Total of all reporting groups
573357|NCT00051025|B2|Baseline|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573358|NCT00051025|B1|Baseline|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573359|NCT00051025|P2|Participant Flow|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573360|NCT00051025|P1|Participant Flow|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573361|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573362|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573363|NCT00051025|O2|Outcome|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573364|NCT00051025|O1|Outcome|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573365|NCT00051025|E2|Reported Event|Ontak 8-Course Group|Eight courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573366|NCT00051025|E1|Reported Event|Ontak 4-Course Group|Four courses of Ontak 9 mcg/kg/day for 5 consecutive days every 21 days
573367|NCT00050986|B1|Baseline|Temozolomide and R115777|
573368|NCT00050986|P1|Participant Flow|Temozolomide and R115777|
573369|NCT00050986|O1|Outcome|Temozolomide and R115777|
573370|NCT00050986|E1|Reported Event|Temozolomide and R115777|
573371|NCT00050960|B3|Baseline|Total|Total of all reporting groups
573372|NCT00050960|B2|Baseline|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
573373|NCT00050960|B1|Baseline|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
573374|NCT00050960|P2|Participant Flow|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
573375|NCT00050960|P1|Participant Flow|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
573376|NCT00050960|O2|Outcome|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
573377|NCT00050960|O1|Outcome|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
573378|NCT00050960|E2|Reported Event|Carboplatin and Paclitaxel|carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks.
573379|NCT00050960|E1|Reported Event|Bexarotene With Carboplatin and Paclitaxel|bexarotene capsules (400 mg/m^2/day) in combination with carboplatin IV (AUC 6) every 3 weeks and paclitaxel IV (200 mg/m^2) every 3 weeks. Subjects in this group also received an antilipid agent which was selected at the discretion of the investigator.
573380|NCT00050778|B4|Baseline|Total|Total of all reporting groups
573381|NCT00050778|B3|Baseline|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573382|NCT00050778|B2|Baseline|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573383|NCT00050778|B1|Baseline|Interferon Beta-1a|Interferon beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573384|NCT00050778|P3|Participant Flow|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573385|NCT00050778|P2|Participant Flow|Alemtuzumab 12 mg|Alemtuzumab (Lemtrada™) 12 milligram per day (mg/day) was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the cluster of differentiation 4+ [CD4+] T-cell count was >=100*10^6 cells per liter).
573386|NCT00050778|P1|Participant Flow|Interferon Beta-1a|Interferon beta-1a (Rebif®) 44 micrograms (mcg) subcutaneously 3-times weekly for 36 months.
573387|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573388|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573389|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573390|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573391|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573392|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573393|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573394|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573395|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573396|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573397|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573398|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573399|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
574739|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
573400|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573401|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573402|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573403|NCT00050778|O4|Outcome|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573404|NCT00050778|O3|Outcome|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573405|NCT00050778|O2|Outcome|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians’ discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573406|NCT00050778|O1|Outcome|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573407|NCT00050778|E4|Reported Event|Alemtuzumab (Pooled)|Included all participants who received alemtuzumab 12 mg/day or 24 mg/day by intravenous infusion on 5 consecutive days during first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573408|NCT00050778|E3|Reported Event|Alemtuzumab 24 mg|Alemtuzumab 24 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573409|NCT00050778|E2|Reported Event|Alemtuzumab 12 mg|Alemtuzumab 12 mg/day was given by intravenous infusion on 5 consecutive days during the first month and on 3 consecutive days at months 12 and 24 (the latter at the treating physicians' discretion if the CD4+ T-cell count was >=100*10^6 cells per liter).
573410|NCT00050778|E1|Reported Event|Interferon Beta-1a|Interferon Beta-1a 44 mcg subcutaneously 3-times weekly for 36 months.
573411|NCT00050622|B1|Baseline|Within-Subject Treatment|All subjects completed a within-subjects crossover of 3 levels of behavior modification and 4 levels of medication.
573412|NCT00050622|P1|Participant Flow|Within-Subject Treatment|All subjects received a within-subjects crossover of 3 levels of behavior modification, randomized in 3-week units, and 4 levels of medication, randomized on a daily basis. Thus each participant experienced all 12 combinations of No, Low, and High Intensity BMOD crossed with Placebo, 0.15 mg/kg MPH, 0.3 mg/kg MPH, and 0.6 mg/kg MPH conditions, with specific conditions changing daily.
573413|NCT00050622|O6|Outcome|High Intensity BMOD + Medication|High Intensity BMOD + Medication (any dose)
573414|NCT00050622|O5|Outcome|Low Intensity BMOD + Med|Low intensity behavior modification + medication (any dose)
573415|NCT00050622|O4|Outcome|Medication Only|No BMOD + Medication (any dose)
573416|NCT00050622|O3|Outcome|High Intensity BMOD ONly|
573417|NCT00050622|O2|Outcome|Low Intensity BMOD Only|
573418|NCT00050622|O1|Outcome|No Treatment|No BMOD, No medication
573419|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573420|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573421|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573422|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
573423|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573424|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573425|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
573426|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
573427|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573428|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573429|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
573430|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
573431|NCT00050622|O12|Outcome|High Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573432|NCT00050622|O11|Outcome|High Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573433|NCT00050622|O10|Outcome|High Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, High Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~High Intensity BMOD: Comprehensive high-intensity STP"
573434|NCT00050622|O9|Outcome|High Intensity BMOD Only|"Placebo, High Intensity BMOD~High Intensity BMOD: Comprehensive high-intensity STP"
573435|NCT00050622|O8|Outcome|Low Intensity BMOD + Higher Dose Medication|"0.6 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573436|NCT00050622|O7|Outcome|Low Intensity BMOD + Medium Dose Medication|"0.3 mg/kg MPH, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573437|NCT00050622|O6|Outcome|Low Intensity BMOD + Low Dose Medication|"0.15 mg/kg MPH, Low Intensity BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate~Low-Intensity BMOD: Lower-intensity behavioral treatment package."
573438|NCT00050622|O5|Outcome|Low Intensity BMOD Only|"Placebo, Low Intensity BMOD~Low-Intensity BMOD: Lower-intensity behavioral treatment package.~Placebo"
573439|NCT00050622|O4|Outcome|Higher Dose Medication Only|"0.6 mg/kg MPH, No BMOD~Methylphenidate 0.6 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573440|NCT00050622|O3|Outcome|Medium Dose Medication Only|"0.3 mg/kg MPH, No BMOD~Methylphenidate 0.3 mg/kg: 0.3 mg/kg/dose immediate-release methylphenidate"
573441|NCT00050622|O2|Outcome|Low Dose Medication Only|"0.15 mg/kg MPH, No BMOD~Methylphenidate 0.15 mg/kg: 0.15 m/kg/dose immediate-release methylphenidate"
573442|NCT00050622|O1|Outcome|No Treatment|"No Medication, No BMOD~Placebo"
573443|NCT00050622|E4|Reported Event|Higher Dose Medication|0.6 mg/kg MPH, No BMOD
573444|NCT00050622|E3|Reported Event|Medium Dose Medication|0.3 mg/kg MPH, No BMOD
573445|NCT00050622|E2|Reported Event|Low Dose Medication|0.15 mg/kg MPH, No BMOD
573446|NCT00050622|E1|Reported Event|Placebo|Placebo
573447|NCT00050089|B5|Baseline|Total|Total of all reporting groups
573448|NCT00050089|B4|Baseline|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
573449|NCT00050089|B3|Baseline|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
573450|NCT00050089|B2|Baseline|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
573451|NCT00050089|B1|Baseline|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
573452|NCT00050089|P4|Participant Flow|ARDFP+Mega-ART|"Antiretroviral Drug-Free Period (ARDFP) and Mega-ART~Intended duration of ARDFP: 12 weeks Mega-ART: 5 or more anti-HIV drugs"
573453|NCT00050089|P3|Participant Flow|ARDFP+Standard-ART|"Antiretroviral Drug-Free Period (ARDFP) and Standard-ART~Intended duration of ARDFP: 12 week2 Standard-ART: up to 4 anti-HIV drugs"
573454|NCT00050089|P2|Participant Flow|No ARDFP+Mega-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Mega-ART~Mega-ART: 5 or more anti-HIV drugs"
573455|NCT00050089|P1|Participant Flow|No ARDFP+Standard-ART|"No Antiretroviral Drug-Free Period (No ARDFP) and Standard-ART~Standard-ART: up to 4 anti-HIV drugs"
573456|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
573457|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
573458|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
573459|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
573460|NCT00050089|O4|Outcome|ARDFP + Mega ART|Intensive ART following ART interruption
573461|NCT00050089|O3|Outcome|ARDFP + Standard ART|Standard ART regimen following ART interruption
573462|NCT00050089|O2|Outcome|No ARDFP + Mega ART|Intensive ART regimen, with no prior ART interruption
573463|NCT00050089|O1|Outcome|No ARDFP + Standard ART|Standard ART regimen, with no prior ART interruption
573464|NCT00050089|O2|Outcome|No ARDFP|This includes participants randomized to No ARDFP (No ARDFP+Standard-ART or No ARDFP+Mega-ART)
573465|NCT00050089|O1|Outcome|ARDFP|This includes participants randomized to ARDFP (ARDFP+Standard-ART or ARDFP+Mega-ART)
573466|NCT00050089|O2|Outcome|Mega-ART|This includes participants randomized to Mega-ART (No ARDFP+Mega-ART or ARDFP+Mega-ART)
573467|NCT00050089|O1|Outcome|Standard-ART|This includes participants randomized to Standard-ART (No ARDFP+Standard-ART or ARDFP+Standard-ART)
573468|NCT00050089|E4|Reported Event|ARDFP + Mega ART|Antiretroviral Treatment Interruption and Intensive ART
573469|NCT00050089|E3|Reported Event|ARDFP + Standard ART|Antiretroviral Treatment Interruption and Standard ART
573470|NCT00050089|E2|Reported Event|No ARDFP + Mega ART|Intensive Antiretroviral Treatment regimen
573471|NCT00050089|E1|Reported Event|No ARDFP + Standard ART|Standard Antiretroviral Treatment regimen
573472|NCT00050011|B3|Baseline|Total|Total of all reporting groups
573473|NCT00050011|B2|Baseline|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
573474|NCT00050011|B1|Baseline|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid upfront 4 mg IV 15-minute infusion every 6 months."
573510|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573511|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573512|NCT00049842|E2|Reported Event|Untreated Control|
573513|NCT00049842|E1|Reported Event|PEG-Intron|
573514|NCT00049543|B3|Baseline|Total|Total of all reporting groups
573475|NCT00050011|P2|Participant Flow|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
573476|NCT00050011|P1|Participant Flow|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence) or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573477|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573478|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573479|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573480|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573481|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573482|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573483|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573484|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573485|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573486|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573515|NCT00049543|B2|Baseline|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573487|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573488|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573489|NCT00050011|O2|Outcome|Zoledronic Acid Delayed Start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on Zoledronic Acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573490|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573491|NCT00050011|O2|Outcome|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573492|NCT00050011|O1|Outcome|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily.~Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573493|NCT00050011|E2|Reported Event|Zoledronic Acid Delayed-start|"In lieu of a placebo arm, which was considered unethical for this trial, a delayed start arm was used. Participants who met certain clinical criteria indicating risk of lumbar spine or total hip fracture, or experienced clinical fracture unrelated to trauma or any asymptomatic fracture discovered at the Month 36 scheduled visit, were started on zoledronic acid 4 mg i.v. and for every 6 months until disease progression (recurrence) or end of study. Participants also received Letrozole 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic acid 4 mg IV 15-minute infusion every 6 months."
573494|NCT00050011|E1|Reported Event|Zoledronic Acid Upfront|"Participants in the upfront arm received Zoledronic Acid 4 mg i.v. on Day 1 and every 6 months until disease progression (recurrence)or the end of study. Participants also received Femara 2.5 daily plus calcium (1000-1200 mg) and vitamin D (400-800 IU) daily.~Letrozole : Participants received 2.5 mg daily. Zoledronic Acid : Participants received Zoledronic Acid 4 mg IV 15-minute infusion every 6 months."
573495|NCT00049842|B3|Baseline|Total|Total of all reporting groups
573496|NCT00049842|B2|Baseline|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573497|NCT00049842|B1|Baseline|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573498|NCT00049842|P2|Participant Flow|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573499|NCT00049842|P1|Participant Flow|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573500|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573501|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573502|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573503|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573504|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573505|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573506|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573507|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573508|NCT00049842|O2|Outcome|Untreated Control|Participants were observed (no treatment given) for 36 months with 4-week follow-up
573509|NCT00049842|O1|Outcome|PEG-Intron (Peginterferon Alfa-2b) 0.5 µg/kg Weekly (QW)|PEG-Intron 0.5 µg/kg weekly (QW) subcutaneously (SC) as maintenance therapy for 36 months with 4-week follow-up
573674|NCT00048724|O2|Outcome|Untreated Control|
573516|NCT00049543|B1|Baseline|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573517|NCT00049543|P2|Participant Flow|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573518|NCT00049543|P1|Participant Flow|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573519|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573520|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573521|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573522|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573523|NCT00049543|O2|Outcome|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573524|NCT00049543|O1|Outcome|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573525|NCT00049543|E2|Reported Event|Arm II (Placebo)|"Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~placebo: Given PO~laboratory biomarker analysis: Correlative studies"
573526|NCT00049543|E1|Reported Event|Arm I (Gefitinib)|"Patients receive gefitinib PO QD for 2 years in the absence of disease progression or unacceptable toxicity.~gefitinib: Given PO~laboratory biomarker analysis: Correlative studies"
573527|NCT00049530|B1|Baseline|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573528|NCT00049530|P1|Participant Flow|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573529|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573530|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573531|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573532|NCT00049530|O1|Outcome|PEG-interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573533|NCT00049530|E1|Reported Event|PEG-Interferon Alfa-2b|Patients receive PEG-interferon alfa-2b subcutaneously (SC) once weekly. Treatment continues until basic fibroblast growth factor level is suppressed to normal or until a maximum weekly dose is reached. If there is disease progression, patients then discontinue treatment. If there is no disease progression, patients receive PEG-interferon alfa-2b SC weekly for up to 1 year in the absence of disease progression or unacceptable toxicity.
573534|NCT00049517|B3|Baseline|Total|Total of all reporting groups
573535|NCT00049517|B2|Baseline|High Dose Daunorubicin (Induction Therapy)|Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.
573536|NCT00049517|B1|Baseline|Standard Daunorubicin (Induction Therapy)|"Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7.~Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course."
573537|NCT00049517|P6|Participant Flow|High-dose Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
573538|NCT00049517|P5|Participant Flow|Standard Daunorubicin Then Allogeneic HCT or no Consolidation|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Patients without CR did not receive any consolidation treatment. Patients in CR with an unfavorable cytogenetic profile or an initial white blood cell count > 100,000/μL were to proceed to allogeneic HCT if they had a suitable human leukocyte antigen (HLA)-matched sibling donor available."
573539|NCT00049517|P4|Participant Flow|High-dose Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
573540|NCT00049517|P3|Participant Flow|Standard Daunorubicin Then GO/Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts. patients randomized to the investigational arm received a single dose of Gemtuzumab ozogamicin (GO) at 6 mg/m2 followed by sargramostim 250 μ/m2 until recovery of counts.~The patients undergoing autologous HCT received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
573541|NCT00049517|P2|Participant Flow|High-dose Daunorubicin Then Autologous HCT|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
573542|NCT00049517|P1|Participant Flow|Standard Daunorubicin Then Autologous HCT|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Consolidation/Transplant:~Before initiating consolidation therapy, patients with CR were randomized to a standard or an investigational arm. All patients received 2 cycles of high-dose cytarabine therapy (3 g/m2 given IV over a 3-hour period every 12 hours every other day for a total of 6 doses), followed by sargramostim 250 μg/m2 until recovery of blood counts.~The patients undergoing autologous hematopoietic cell transplantation (HCT) received intravenous busulfan 0.8 mg/kg every 6 hours for 16 doses (without pharmacokinetic sampling) followed by intravenous cyclophosphamide 60 mg/kg daily for 2 days."
573543|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
573544|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
573545|NCT00049517|O2|Outcome|Go/Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
573546|NCT00049517|O1|Outcome|Autologous HCT|Patients with CR in the induction phase were randomized to receive autologous HCT or GO/autologous HCT.
573547|NCT00049517|O2|Outcome|High-dose Daunorubicin|Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
573548|NCT00049517|O1|Outcome|Standard Daunorubicin|Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course. Patients with CR received consolidation treatment thereafter.
573549|NCT00049517|E2|Reported Event|High Dose Daunorubicin (Induction Therapy)|"Induction: Patients receive high-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine as in arm I. Patients may receive a second course of induction therapy if CR is not achieved after the first course. The second course is administered as in arm I.~Conditioning/Transplant:~Patients receive gemtuzumab ozogamicin IV over 2 hours on day 1 and GM-CSF SC or IV beginning on day 10 and continuing until blood counts recover. Within 2-3 weeks after blood count recovery, patients receive conditioning and undergo autologous PBSC transplantation as in arm I."
573550|NCT00049517|E1|Reported Event|Standard Daunorubicin (Induction Therapy)|"Induction: Patients receive standard-dose daunorubicin IV over 10-15 minutes on days 1-3 and cytarabine IV continuously on days 1-7. Patients may receive a second course of induction therapy if complete remission (CR) is not achieved after the first course.~Conditioning/Transplant:~Patients receive conditioning comprising busulfan IV every 6 hours on days -7 to -4 and cyclophosphamide IV over 2 hours on days -3 and -2. Patients then undergo autologous peripheral blood stem cell (PBSC) transplantation on day 0. Patients receive sargramostim (GM-CSF) or filgrastim (G-CSF) IV or subcutaneously (SC) beginning on day 0 and continuing until blood counts recover."
573551|NCT00049322|B3|Baseline|Total|Total of all reporting groups
573552|NCT00049322|B2|Baseline|Arm II (TACE-O Arm )|Observation
575297|NCT00041717|E1|Reported Event|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
573553|NCT00049322|B1|Baseline|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573554|NCT00049322|P2|Participant Flow|Arm II (TACE-O Arm )|Observation
573555|NCT00049322|P1|Participant Flow|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573556|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573557|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573558|NCT00049322|O2|Outcome|Arm II-chemoembolization|chemoembolization as part of standard of care
573559|NCT00049322|O1|Outcome|Arm I-bevacizumab|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573560|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
573561|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573562|NCT00049322|O2|Outcome|Arm II (TACE-O Arm )|Observation
573563|NCT00049322|O1|Outcome|Arm I (TACE-BEV Arm)|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first (transarterial chemoembolization TACE)chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab : Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573564|NCT00049322|E2|Reported Event|Arm II|Patients do not receive bevacizumab
573565|NCT00049322|E1|Reported Event|Arm I|"Patients receive bevacizumab IV over 30-90 minutes once every 2 weeks beginning 1 week prior to the first chemoembolization at a dose of 10 mg/kg. Courses repeat every 2 weeks in the absence of disease progression or unacceptable toxicity.~bevacizumab: Given IV, 10mg/kg evey two weeks starting 1 week prior to the first chemoembolization.~Patients crossed over to the Bevacizumab arm will receive Bevacizumab after week 14 at the same dose."
573566|NCT00049257|B1|Baseline|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573567|NCT00049257|P1|Participant Flow|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573568|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573569|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573570|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573571|NCT00049257|O1|Outcome|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573572|NCT00049257|E1|Reported Event|Carboplatin, Paclitaxel|"Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter."
573573|NCT00049127|B6|Baseline|Total|Total of all reporting groups
573574|NCT00049127|B5|Baseline|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573575|NCT00049127|B4|Baseline|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573576|NCT00049127|B3|Baseline|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573577|NCT00049127|B2|Baseline|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573578|NCT00049127|B1|Baseline|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573579|NCT00049127|P5|Participant Flow|Study 3 Arm E|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at 300 mg b.i.d."
573580|NCT00049127|P4|Participant Flow|Study 3 Arm D|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and >2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
573581|NCT00049127|P3|Participant Flow|Study 2 Arm B|"Phase II patients not on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at 300 mg b.i.d."
573582|NCT00049127|P2|Participant Flow|Study 2 Arm A|"Phase II patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at Maximum Tolerated Dose (MTD) from Study 1 mg p.o. bid daily"
573583|NCT00049127|P1|Participant Flow|Study 1 Arm C|"Phase I patients on enzyme-inducing anticonvulsants (EIACs) and <=2 prior regimens~Imatinib at assigned dose. Escalation of cohorts-of-3 per section 7.1 of the protocol. Assigned dose will be administered p.o. twice daily in divided doses."
573584|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573585|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573586|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573587|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573588|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573589|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573590|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573591|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573592|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573593|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573594|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573595|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573596|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573597|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573598|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573599|NCT00049127|O5|Outcome|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573600|NCT00049127|O4|Outcome|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573601|NCT00049127|O3|Outcome|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573602|NCT00049127|O2|Outcome|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573603|NCT00049127|O1|Outcome|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573604|NCT00049127|E5|Reported Event|Study 3 Arm E|Phase II patients not on EIACs and >2 prior regimens
573605|NCT00049127|E4|Reported Event|Study 3 Arm D|Phase II patients on EIACs and >2 prior regimens
573606|NCT00049127|E3|Reported Event|Study 1 Arm C|Phase I patients on EIACs and <=2 prior regimens
573607|NCT00049127|E2|Reported Event|Study 2 Arm B|Phase II patients not on EIACs and <=2 prior regimens
573608|NCT00049127|E1|Reported Event|Study 2 Arm A|Phase II patients on EIACs and <=2 prior regimens
573609|NCT00049036|B3|Baseline|Total|Total of all reporting groups
573610|NCT00049036|B2|Baseline|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
573611|NCT00049036|B1|Baseline|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
573612|NCT00049036|P2|Participant Flow|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
573613|NCT00049036|P1|Participant Flow|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
573614|NCT00049036|O2|Outcome|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
573615|NCT00049036|O1|Outcome|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
573616|NCT00049036|E2|Reported Event|EPOCH Followed by Rituximab|Patients do not receive rituximab concurrently with chemotherapy. Beginning 4 weeks after completion of chemotherapy, patients receive rituximab IV over 2-4 hours weekly for 6 weeks.
573617|NCT00049036|E1|Reported Event|EPOCH + Concurrent Rituximab|Patients receive rituximab IV over 2-4 hours prior to each course of chemotherapy. Treatment repeats every 3 weeks for 4-6 courses. Patients who achieve a complete response after 4 courses of chemotherapy and rituximab receive additional rituximab alone weekly for 2 weeks.
573618|NCT00048997|B3|Baseline|Total|Total of all reporting groups
573619|NCT00048997|B2|Baseline|Observation|Observation.
573620|NCT00048997|B1|Baseline|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
573621|NCT00048997|P2|Participant Flow|Observation|Observation
573622|NCT00048997|P1|Participant Flow|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
573623|NCT00048997|O2|Outcome|Observation|Observation
573624|NCT00048997|O1|Outcome|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy.
575298|NCT00041392|B3|Baseline|Total|Total of all reporting groups
573625|NCT00048997|E1|Reported Event|Prophylactic Cranial Irradiation (PCI)|PCI is given to the whole brain in a dose of 2 Gy per fraction, 5 days per week, for 3 weeks for a total dose of 30 Gy..
573626|NCT00048932|B3|Baseline|Total|Total of all reporting groups
573627|NCT00048932|B2|Baseline|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573628|NCT00048932|B1|Baseline|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573629|NCT00048932|P3|Participant Flow|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573630|NCT00048932|P2|Participant Flow|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573631|NCT00048932|P1|Participant Flow|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573632|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573633|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573634|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573635|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573636|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573637|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573638|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573639|NCT00048932|O1|Outcome|OL ABA|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573640|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573641|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573642|NCT00048932|O1|Outcome|All Treated Participants|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573643|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573644|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573645|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573646|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573647|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573675|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
573648|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573649|NCT00048932|O2|Outcome|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573650|NCT00048932|O1|Outcome|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for participants < 60 kg, 750 mg for participants 60 to 100 kg and 1 g for participants > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573651|NCT00048932|E3|Reported Event|Placebo (PLA)|Participants received Placebo (dextrose 5% water [D5W] for injection U.S.P or normal saline [NS]) for IV infusion administered on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573652|NCT00048932|E2|Reported Event|Abatacept (ABA)|Participants received a fixed dose of abatacept approximating 10 mg/kg (500 mg for subjects < 60 kg, 750 mg for subjects 60 to 100 kg and 1 g for subjects > 100 kg). Abatacept was administered intravenously (IV) on Days 1, 15, 29, and every 28 days thereafter, for a total of 14 doses. Participants also received background therapy(ies) for rheumatoid arthritis (RA) (non-biologic or biologic disease-modifying drugs [DMARDs], or combination) throughout the double-blind treatment period.
573653|NCT00048932|E1|Reported Event|Open Label (OL) Abatacept|Participants received abatacept (weight-tiered 10 mg/kg dose) IV every 28 days during the open-label period.
573654|NCT00048893|B1|Baseline|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573655|NCT00048893|P1|Participant Flow|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573656|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573657|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573658|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573659|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573660|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573661|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573662|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573663|NCT00048893|O1|Outcome|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573664|NCT00048893|E1|Reported Event|Carcinoembryonic Antigen (CEA)-Tricom Vaccines|(fV-CEA (6D)/Tricom with sargramostim (rGM-CSF) 1.5 x 10^8 plaque-forming unit (pfu) x 1 dose subcutaneously
573665|NCT00048737|B1|Baseline|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
573666|NCT00048737|P1|Participant Flow|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
573667|NCT00048737|O1|Outcome|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab: 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
573668|NCT00048737|E1|Reported Event|90Y Zevalin in ASCT|"Allogeneic Stem Cell (AST) Transplantation with 90Y Zevalin/Cyclophosphamide/Fludarabine as a preparative regimen.~Rituximab : 250 mg/m^2 on day 1 and day 8~Allogeneic Stem Cell Transplantation : Allogeneic stem cell transplantation 2 days after chemotherapy~Cyclophosphamide : 750 mg/m^2/day x 3, given on the same days as fludarabine, at 4-hour intervals~Zevalin Radioimmunotherapy : Escalating single dose of 90Y Zevalin 0.2-0.3-0.4 mCi/kg~Fludarabine : 30 mg/m^2/day x 3"
573669|NCT00048724|B3|Baseline|Total|Total of all reporting groups
573670|NCT00048724|B2|Baseline|Untreated Control|
573671|NCT00048724|B1|Baseline|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
573672|NCT00048724|P2|Participant Flow|Untreated Control|
573673|NCT00048724|P1|Participant Flow|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
573677|NCT00048724|O1|Outcome|PegIntron|PegIntron 0.5 µg/kg subcutaneously once weekly as maintenance therapy for 60 months with a 4-week post-treatment follow-up
573678|NCT00048724|E2|Reported Event|Untreated Control|
573679|NCT00048724|E1|Reported Event|PegIntron|
573680|NCT00048581|B3|Baseline|Total|Total of all reporting groups
573681|NCT00048581|B2|Baseline|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573682|NCT00048581|B1|Baseline|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573683|NCT00048581|P3|Participant Flow|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573684|NCT00048581|P2|Participant Flow|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573685|NCT00048581|P1|Participant Flow|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573686|NCT00048581|O1|Outcome|All Treated Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573687|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573688|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573689|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573690|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573691|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573692|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573693|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573694|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573695|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573696|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573697|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
574074|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573698|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573699|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573700|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573701|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573702|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573703|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573704|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573705|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573706|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573707|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573708|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573709|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573710|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573711|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573712|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573713|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573714|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573715|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573716|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573717|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573718|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573719|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573720|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573721|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
574090|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573722|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573723|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573724|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573725|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573726|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573727|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573728|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573729|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573730|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573731|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573732|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573733|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573734|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573735|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573736|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573737|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573738|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573739|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573740|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573741|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573742|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573743|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573744|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573745|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
574106|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573746|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573747|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573748|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573749|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573750|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573751|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573752|NCT00048581|O1|Outcome|OL: ABA|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573753|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573754|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573755|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573756|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573757|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573758|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573759|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573760|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573761|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573762|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573763|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573764|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573765|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573766|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573767|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573768|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573769|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573770|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573771|NCT00048581|O2|Outcome|OL: PLA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573772|NCT00048581|O1|Outcome|OL: ABA|Participants treated in the OL who were randomized to receive placebo on a background of DMARDs in the DB. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs IV on Days 1, 15, 29, 57, 85, 113, and 141.
573773|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573774|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573775|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573776|NCT00048581|O1|Outcome|All Treated DB Participants|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive either abatacept or placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram of abatacept. Abatacept or placebo was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573777|NCT00048581|O1|Outcome|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period, based on their entry weight into the study. Participant dose was adjusted based on annual anniversary weight. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573778|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573779|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573780|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573781|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573782|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573870|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
575299|NCT00041392|B2|Baseline|0.9 % Saline|100 mg/kg 0.9 % saline
573783|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573784|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573785|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573786|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573787|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573788|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573789|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573790|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573791|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573792|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573793|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573794|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573795|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573796|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
575300|NCT00041392|B1|Baseline|Magnesium|100 mg/kg magnesium
573797|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573798|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573799|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573800|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573801|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573802|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573803|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573804|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573805|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573806|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573807|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573808|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573809|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573810|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
575301|NCT00041392|P2|Participant Flow|0.9 % Saline|100 mg/kg 0.9 % saline
573811|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573812|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573813|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573814|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573815|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573816|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573817|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573818|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573819|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573820|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573821|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573822|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573823|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573824|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
575302|NCT00041392|P1|Participant Flow|Magnesium|100 mg/kg magnesium
573825|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573826|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573827|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573828|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573829|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573830|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573831|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573832|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573833|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573834|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573835|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573836|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573837|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573838|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
575303|NCT00041392|O2|Outcome|0.9 % Saline|100 mg/kg 0.9 % saline
573839|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573840|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573841|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573842|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573843|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573844|NCT00048581|O2|Outcome|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573845|NCT00048581|O1|Outcome|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573846|NCT00048581|E3|Reported Event|Placebo (PLA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive placebo on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, and 141.
573847|NCT00048581|E2|Reported Event|Abatacept (ABA)|Participants with active RA who met the inclusion/exclusion criteria for this study were randomized to receive abatacept on a background of DMARDs. Participants must have been treated with anti-TNF therapy for at least 3 months and designated as anti-TNF therapy failures due to inadequate efficacy. Participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29 and every 28 days thereafter for a total of 7 doses. Each dose was infused intravenously over approximately 30 minutes.
573848|NCT00048581|E1|Reported Event|Open-label ABA|All participants who completed the double-blind period were eligible to continue in the open-label period. At the beginning of the open-label period (Day 169), all eligible participants were re-allocated to a 10 mg/kg weight-tiered dose of abatacept at their enrollment visit into the open-label period. Participants weighing > 100 kg received 1 g, participants weighing ≥ 60 kg and ≤ 100 kg received 750 mg, and participants weighing < 60 kg received 500 mg on a background of DMARDs (at discretion of the investigator). Concomitant biologic RA therapies were later excluded.
573849|NCT00048568|B3|Baseline|Total|Total of all reporting groups
573850|NCT00048568|B2|Baseline|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573851|NCT00048568|B1|Baseline|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573852|NCT00048568|P3|Participant Flow|ABA + MTX [Open-label (OL)]|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573853|NCT00048568|P2|Participant Flow|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo was administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
575304|NCT00041392|O1|Outcome|Magnesium|100 mg/kg magnesium
573854|NCT00048568|P1|Participant Flow|Abatacept (ABA) + Methotrexate (MTX) DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
573855|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573856|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573857|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573858|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573859|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573860|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573861|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573862|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573863|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573864|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573865|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573866|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573867|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573868|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573869|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
575305|NCT00041392|E2|Reported Event|0.9 % Saline|100 mg/kg 0.9 % saline
573871|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573872|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573873|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573874|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573875|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573876|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573877|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573878|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573879|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573880|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573881|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573882|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573883|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573884|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573885|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573886|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573935|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573887|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573888|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573889|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573890|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573891|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573892|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573893|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573894|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573895|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573896|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573897|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573898|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573899|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573900|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573901|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573902|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573936|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573903|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573904|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573905|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573906|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573907|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573908|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573909|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573910|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573911|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573912|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573913|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573914|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573915|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573916|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573917|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573918|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573937|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573919|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573920|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573921|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573922|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573923|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573924|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
573925|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573926|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
573927|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573928|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
573929|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573930|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
573931|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573932|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
573933|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573934|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574177|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
573938|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573939|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573940|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573941|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573942|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573943|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573944|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573945|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573946|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573947|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573948|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573949|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573950|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573951|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573952|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573953|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573954|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573955|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574178|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574179|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
573956|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573957|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573958|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573959|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573960|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573961|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573962|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573963|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573964|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573965|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573966|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573967|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573968|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573969|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573970|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573971|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573972|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573973|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573974|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573975|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573976|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573977|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573978|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573979|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573980|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573981|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573982|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573983|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573984|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573985|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573986|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573987|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573988|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574008|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573989|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573990|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
573991|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573992|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573993|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573994|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573995|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573996|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573997|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
573998|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
573999|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574000|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574001|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574002|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574003|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574004|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574005|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574006|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574007|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
575306|NCT00041392|E1|Reported Event|Magnesium|100 mg/kg magnesium
574009|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574010|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574011|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574012|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574013|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA + MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574014|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574015|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574016|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574017|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574018|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574019|NCT00048568|O1|Outcome|ABA + MTX Cumulative DB + OL Periods|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB and OL periods under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574020|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574021|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574022|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574023|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574024|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574180|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
574025|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574026|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574027|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574028|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574029|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574030|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574031|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574032|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574033|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574034|NCT00048568|O2|Outcome|MTX + Placebo|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574035|NCT00048568|O1|Outcome|ABA + MTX|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574036|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574037|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574038|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574039|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574040|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574041|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574042|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574043|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574044|NCT00048568|O2|Outcome|MTX + Placebo DB|Participants that received MTX + placebo in the DB treatment period (Day 1 to Day 365) but are currently receiving treatment with ABA +MTX in the OL period. Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574045|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574046|NCT00048568|O2|Outcome|Placebo + MTX DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574047|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574048|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574049|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574050|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574051|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574052|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574053|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574054|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the DB period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; particiapnts ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and particpants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the OL period.
574055|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574056|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574057|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574181|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
574058|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574059|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574060|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574061|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574062|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574063|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574064|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574065|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574066|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574067|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574068|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574069|NCT00048568|O1|Outcome|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574070|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574071|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574072|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574073|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574182|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574075|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574076|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574077|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574078|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574079|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574080|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574081|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574082|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574083|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574084|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574085|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574086|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574087|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574088|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574089|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574183|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
574091|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574092|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574093|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574094|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574095|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574096|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574097|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574098|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574099|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574100|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574101|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574102|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574103|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574104|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574105|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574184|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
574107|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574108|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574109|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574110|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574111|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574112|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574113|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574114|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574115|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574116|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574117|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574118|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574119|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574120|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574121|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574185|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
574122|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574123|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574124|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574125|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574126|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574127|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574128|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574129|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
574130|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574131|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed by weight with participants weighing < 60 kg received 500 mg, subjects weighing 60 kg to 100 kg received 750 mg, and subjects weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of (10-30 mg/wk), although doses of < 10 mg/wk were acceptable if due to toxicity.
574132|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574133|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574134|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574135|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574136|NCT00048568|O2|Outcome|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574137|NCT00048568|O1|Outcome|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
575376|NCT00040664|O1|Outcome|FPV Tablet|Fosamprenavir 700 mg tablets/ritonavir 100 mg capsules once daily
574138|NCT00048568|E3|Reported Event|MTX + Placebo DB|Control group receiving MTX treatment in combination with placebo. Participants received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity. Placebo and MTX were administered IV on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337.
574139|NCT00048568|E2|Reported Event|ABA + MTX DB|Abatacept was dosed intravenously by weight with participants weighing < 60 kg received 500 mg, participants weighing 60 kg to 100 kg received 750 mg, and participants weighing > 100 kg received 1 gram. Study medication was administered on Days 1, 15, 29, and every 28 days thereafter for a total of 14 doses. Each dose was infused intravenously over approximately 30 minutes on Days 1, 15, 29, 57, 85, 113, 141, 169, 197, 225, 253, 281, 309, and 337. Participants also received MTX at a minimum dose of 10-30 mg/wk, although doses of < 10 mg/wk were acceptable if due to toxicity.
574140|NCT00048568|E1|Reported Event|ABA + MTX OL|Abatacept was dosed intravenously by weight at 10 mg/kg in the OL period under tiered dosing such that participants weighing < 60 kg received abatacept 500 mg; participants ≥ 60 kg and ≤ 100 kg received abatacept 750 mg; and participants > 100 kg received abatacept 1 g. MTX was continued at the dose used in the DB period.
574141|NCT00048542|B5|Baseline|Total|Total of all reporting groups
574142|NCT00048542|B4|Baseline|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574143|NCT00048542|B3|Baseline|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574144|NCT00048542|B2|Baseline|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
574145|NCT00048542|B1|Baseline|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574146|NCT00048542|P8|Participant Flow|Open-Label Extension FD Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574147|NCT00048542|P7|Participant Flow|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study in which only body weight (not BSA) determined dosing. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574148|NCT00048542|P6|Participant Flow|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
574149|NCT00048542|P5|Participant Flow|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
574150|NCT00048542|P4|Participant Flow|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574151|NCT00048542|P3|Participant Flow|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574152|NCT00048542|P2|Participant Flow|Double-Blind Placebo + MTX|"Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study.~MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening."
574153|NCT00048542|P1|Participant Flow|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574186|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574482|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574154|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574155|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574156|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574157|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574158|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574159|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574160|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574161|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574162|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574163|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574164|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574165|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574166|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574167|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574168|NCT00048542|O2|Outcome|OLE FD Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension Fixed Dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574169|NCT00048542|O1|Outcome|OLE FD Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension fixed dose phase. Subjects weighing less than 30 kg were dosed with 20 mg of adalimumab subcutaneously (SC) every other week (eow). Subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574170|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574171|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574172|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574173|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574174|NCT00048542|O2|Outcome|OLE BSA Adalimumab|Subjects received adalimumab, but not concomitant MTX, during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574175|NCT00048542|O1|Outcome|OLE BSA Adalimumab + MTX|Subjects received adalimumab and concomitant MTX during the Open-Label Extension body surface area (BSA) phase. Subjects received OL adalimumab (24 mg/m2 BSA up to a maximum of 40 mg total body dose subcutaneously (SC) every other week (eow).
574176|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
576000|NCT00031460|P1|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
574187|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
574188|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
574189|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
574190|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574191|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
574192|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
574193|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX double-blind phase.
574194|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574195|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during open-label lead-in phase and during the double-blind phase.
574196|NCT00048542|O4|Outcome|Placebo + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and placebo plus MTX during the double-blind phase.
574197|NCT00048542|O3|Outcome|Adalimumab + MTX|Subjects received adalimumab plus MTX during the open-label lead-in phase and adalimumab plus MTX during the double-blind phase.
574198|NCT00048542|O2|Outcome|Placebo|Subjects received adalimumab during the open-label lead-in phase and placebo during the double-blind phase.
574199|NCT00048542|O1|Outcome|Adalimumab|Subjects received adalimumab during the open-label lead-in phase and during the double-blind phase.
574200|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574201|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg per square meter of body surface area [BSA] every other week [eow]) plus concomitant MTX treatment during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574202|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574203|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574204|NCT00048542|O2|Outcome|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574205|NCT00048542|O1|Outcome|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab plus concomitant MTX during the Double-Blind Phase. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574206|NCT00048542|O2|Outcome|Adalimumab|Subjects received open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]), but no methotrexate (MTX), during the Open-Label Lead-In (OL-LI) Phase of the study.
574207|NCT00048542|O1|Outcome|Adalimumab + MTX|Subjects received methotrexate (MTX) plus open-label adalimumab (24 mg/square meter up to a maximum of 40 mg total body dose by body surface area [BSA] administered subcutaneously [SC] every other week [eow]) during the Open-Label Lead-In (OL-LI) Phase of the study.
574208|NCT00048542|O2|Outcome|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574209|NCT00048542|O1|Outcome|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], not to exceed 40 mg, every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574210|NCT00048542|E8|Reported Event|Open-Label Extension FD Adalimumab|Subjects in the methotrexate (MTX) stratum received adalimumab without concomitant MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
574211|NCT00048542|E7|Reported Event|Open-Label Extension FD Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received adalimumab concomitantly with MTX treatment during the Open-Label Extension (OLE) Fixed Dose (FD) Phase of the study, in which subjects were dosed based on body weight (not BSA). Subjects were separated into 2 body weight categories; subjects weighing less than 30 kg were dosed with 20 mg of adalimumab SC eow, and subjects weighing 30 kg or more were dosed with 40 mg of adalimumab SC eow.
576001|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
574212|NCT00048542|E6|Reported Event|Open-Label Extension BSA Adalimumab|Subjects in the non-methotrexate (MTX) stratum received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose SC eow) without concomitant MTX treatment during the Open-Label Extension BSA Phase.
574213|NCT00048542|E5|Reported Event|Open-Label Extension BSA Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum received subcutaneous injections of 24 mg adalimumab per square meter of body surface area (BSA) up to a maximum of 40 mg total body dose every other week (eow) concomitantly with MTX treatment during the Open-Label Extension BSA Phase of the study.
574214|NCT00048542|E4|Reported Event|Double-Blind Placebo|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose, administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574215|NCT00048542|E3|Reported Event|Double-Blind Adalimumab|Subjects in the non-methotrexate (MTX) stratum who were either naïve to MTX or withdrawn from MTX at least 2 weeks prior to study drug administration, and were adalimumab responders during the OL-LI phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week), but no concomitant MTX treatment, during the Double-Blind Phase of the study.
574216|NCT00048542|E2|Reported Event|Double-Blind Placebo + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received placebo (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574217|NCT00048542|E1|Reported Event|Double-Blind Adalimumab + MTX|Subjects in the methotrexate (MTX) stratum, who had an inadequate response to MTX and were adalimumab responders during the Open-Label Lead-In (OL-LI) phase, received adalimumab (24 mg/square meter of body surface area [BSA], up to a maximum of 40 mg total body dose administered subcutaneously every other week) plus concomitant MTX treatment during the Double-Blind Phase of the study. MTX-treated inadequate responders must have had active disease on MTX treatment for at least 3 months prior to screening.
574218|NCT00048347|B1|Baseline|Avonex|30 µg IM every week for 12 weeks
574219|NCT00048347|P1|Participant Flow|Avonex|30 µg IM every week for 12 weeks
574220|NCT00048347|O1|Outcome|Avonex|30 µg IM every week for 12 weeks
574221|NCT00048347|E1|Reported Event|Avonex|30 µg IM every week for 12 weeks
574222|NCT00048165|B3|Baseline|Total|Total of all reporting groups
574223|NCT00048165|B2|Baseline|Placebo|Eligible participants were administered an intravenous matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574224|NCT00048165|B1|Baseline|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574225|NCT00048165|P2|Participant Flow|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574226|NCT00048165|P1|Participant Flow|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574227|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574228|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574229|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574230|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574231|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574232|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574233|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574234|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574235|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574236|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574237|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574238|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574239|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574240|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574241|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574242|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574243|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574244|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574263|NCT00048074|P1|Participant Flow|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574264|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574245|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574246|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574247|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574248|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574249|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574250|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574251|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574252|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574253|NCT00048165|O2|Outcome|Placebo|Eligible participants were administered an IV dose of matching placebo (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574254|NCT00048165|O1|Outcome|Daclizumab|Eligible participants were administered an intravenous (IV) dose of daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID]), cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV peri-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574255|NCT00048165|E2|Reported Event|Placebo|Eligible participants were administered an IV dose of matching placebo on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574256|NCT00048165|E1|Reported Event|Daclizumab|Eligible participants were administered an intravenous daclizumab (1 milligrams per kilogram [mg/kg]) on Days 1, 8, 22, 36, and 50, along with mycophenolate mofetil (one dose of 1.5 mg twice daily [BID], cyclosporine (1-4 mg/kg IV or 2-6 mg/kg orally/nasogastric), and corticosteroid (methylprednisolone, 500-1000 mg IV pre-operative switch to oral at 0.5-1 mg/kg/day followed by tapering). Participants received mycophenolate mofetil, cyclosporine, and corticosteroid up to 365 days.
574257|NCT00048074|B4|Baseline|Total|Total of all reporting groups
574258|NCT00048074|B3|Baseline|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574259|NCT00048074|B2|Baseline|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574260|NCT00048074|B1|Baseline|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574261|NCT00048074|P3|Participant Flow|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574262|NCT00048074|P2|Participant Flow|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574265|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574266|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574267|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574268|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574269|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574270|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574271|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574272|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574273|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574274|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574275|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574276|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574277|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574278|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574279|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574280|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574281|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574282|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574283|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574284|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574285|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574286|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574287|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574288|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574289|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574290|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574291|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574292|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574293|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574294|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574295|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574296|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574297|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574298|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574299|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574300|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574301|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574302|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574303|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574304|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574305|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574306|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574307|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574308|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574309|NCT00048074|O3|Outcome|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574310|NCT00048074|O2|Outcome|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574311|NCT00048074|O1|Outcome|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574312|NCT00048074|E3|Reported Event|Ibandronate 3mg q 3 mo IV|Participants received 3 mg of ibandronate IV every three months and placebo tablet daily for a total treatment period of 24 months.
574313|NCT00048074|E2|Reported Event|Ibandronate 2mg q 2 mo IV|Participants received 2 mg of ibandronate intravenously (IV) every two months and placebo tablet daily for a total treatment period of 24 months.
574314|NCT00048074|E1|Reported Event|Ibandronate 2.5mg Daily|Participants received 2.5 milligrams (mg) of ibandronate orally daily and IV placebo injection at intervals of either 2 or 3 months for a total treatment period of 24 months.
574315|NCT00048061|B5|Baseline|Total|Total of all reporting groups
574316|NCT00048061|B4|Baseline|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574317|NCT00048061|B3|Baseline|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574318|NCT00048061|B2|Baseline|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574319|NCT00048061|B1|Baseline|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574320|NCT00048061|P4|Participant Flow|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574321|NCT00048061|P3|Participant Flow|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574322|NCT00048061|P2|Participant Flow|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574323|NCT00048061|P1|Participant Flow|Ibandronate 2.5 mg|Participants received 2.5 milligram (mg) ibandronate Per oral (PO) daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 international units (IU) per day.
574324|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574325|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574326|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574327|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574328|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574329|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574359|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574330|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574331|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574332|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574333|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574334|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574335|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574336|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574337|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574338|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574339|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574340|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574341|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574342|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574343|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574344|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574345|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574346|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574347|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574348|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574349|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574350|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574351|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574352|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574353|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574354|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574355|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574356|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574357|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574358|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574483|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574360|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574361|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574362|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574363|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574364|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574365|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574366|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574367|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574368|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574369|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574370|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574371|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574372|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574373|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574374|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574375|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574376|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574377|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574378|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574379|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574380|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574381|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574382|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574383|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574384|NCT00048061|O4|Outcome|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574385|NCT00048061|O3|Outcome|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574386|NCT00048061|O2|Outcome|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574387|NCT00048061|O1|Outcome|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574388|NCT00048061|E4|Reported Event|Ibandronate 150 mg|Participants received 150 mg ibandronate PO monthly taken on a single day and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574484|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574389|NCT00048061|E3|Reported Event|Ibandronate 100 mg|Participants received 100 mg ibandronate PO monthly divided over two consecutive days (50 mg tablet/day) and a round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574390|NCT00048061|E2|Reported Event|Ibandronate 50/50 mg|Participants received 100 mg ibandronate PO monthly taken on a single day (2 X 50 mg tablets) and round placebo tablet PO daily. Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574391|NCT00048061|E1|Reported Event|Ibandronate 2.5 mg|Participants received 2.5 mg ibandronate PO daily and an oblong placebo tablet PO monthly Participants also received calcium 500 mg /day and vitamin D 400 IU/day.
574392|NCT00048035|B7|Baseline|Total|Total of all reporting groups
574393|NCT00048035|B6|Baseline|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574394|NCT00048035|B5|Baseline|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574395|NCT00048035|B4|Baseline|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574396|NCT00048035|B3|Baseline|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574397|NCT00048035|B2|Baseline|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574398|NCT00048035|B1|Baseline|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574399|NCT00048035|P8|Participant Flow|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574400|NCT00048035|P7|Participant Flow|RO0503821 (1x/Week)|Eligible participants were administered intravenously (IV) RO0503821 (methoxy polyethylene glycol-epoetin beta [Mircera]) once weekly (1x/ week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 microgram (mcg)/kilogram (kg) of the previous weekly erythropoiesis stimulating agents (ESA) dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574401|NCT00048035|P6|Participant Flow|Cohort 6 (RO0503821 [0.6/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574402|NCT00048035|P5|Participant Flow|Cohort 5 (RO0503821 [0.6/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574403|NCT00048035|P4|Participant Flow|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574404|NCT00048035|P3|Participant Flow|Cohort 3 (RO0503821 [0.4/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574405|NCT00048035|P2|Participant Flow|Cohort 2 (RO0503821 [0.25/150 1x/2 Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574406|NCT00048035|P1|Participant Flow|Cohort 1 (RO0503821 [0.25/150 1x/ Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574442|NCT00047879|B2|Baseline|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574407|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574408|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574409|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574410|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574411|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574412|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574413|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574414|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574415|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574416|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574417|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574418|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574419|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574420|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574421|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574422|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574423|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574424|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574425|NCT00048035|O2|Outcome|RO0503821 (1x/2Week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574426|NCT00048035|O1|Outcome|RO0503821 (1x/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574427|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574428|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574429|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to 100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574430|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574431|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574432|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to 62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574433|NCT00048035|O6|Outcome|Cohort 6 (RO0503821 [0.6/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574434|NCT00048035|O5|Outcome|Cohort 5 (RO0503821 [0.6/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.60/150 mcg/kg of the previous weekly ESA dose, (equal to150% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574435|NCT00048035|O4|Outcome|Cohort 4 (RO0503821 [0.4/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574436|NCT00048035|O3|Outcome|Cohort 3 (RO0503821 [0.4/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.40/150 mcg/kg of the previous weekly ESA dose, (equal to100% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574437|NCT00048035|O2|Outcome|Cohort 2 (RO0503821 [0.25/150 1x/2week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once in every two weeks up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574438|NCT00048035|O1|Outcome|Cohort 1 (RO0503821 [0.25/150 1x/Week])|Eligible participant were administered RO0503821 IV using a dose conversion factor of 0.25/150 mcg/kg of the previous weekly ESA dose, (equal to62.50% assumed equi-effective dose) once weekly up to 19 weeks. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574439|NCT00048035|E2|Reported Event|RO0503821 (1/2week)|Eligible participants were administered IV RO0503821 once every two weeks (1x/ 2week) using a dose conversion factor of 0.25/150-, 0.40/150-, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 2, Cohort 4, and Cohort 6, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574440|NCT00048035|E1|Reported Event|RO0503821 (1/Week)|Eligible participants were administered IV RO0503821 once weekly (1x/ week) using a dose conversion factor of 0.25/150, 0.40/150, and 0.60/150 mcg/kg of the previous weekly ESA dose in Cohort 1, Cohort 3, and Cohort 5, respectively for 19 weeks. The ESA dose 62.5%, 100%, and 150% assumed equi-effective dose for dose conversion factors 0.25/150, 0.40/150 and 0.60/150, respectively. After 19 weeks of core treatment period, participants were followed-up for two optional treatment extension periods (54 weeks each).
574441|NCT00047879|B3|Baseline|Total|Total of all reporting groups
574443|NCT00047879|B1|Baseline|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574444|NCT00047879|P2|Participant Flow|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574445|NCT00047879|P1|Participant Flow|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574446|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574447|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574448|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574449|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574450|NCT00047879|O2|Outcome|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574451|NCT00047879|O1|Outcome|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574452|NCT00047879|E2|Reported Event|Anaplastic Glioma Stratum|Anaplastic glioma is a type of brain tumor that develops from star-shaped glial cells that support nerve cells. Anaplastic oligodendroglioma is a malignant type of brain tumor sensitive to treatment with chemotherapy and radiotherapy.
574453|NCT00047879|E1|Reported Event|Glioblastoma Multiforme Stratum|Glioblastoma multiforme is one of the most common and aggressive types of brain tumor.
574454|NCT00047619|B3|Baseline|Total|Total of all reporting groups
574455|NCT00047619|B2|Baseline|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage not directed at wound or patient"
574456|NCT00047619|B1|Baseline|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
574457|NCT00047619|P2|Participant Flow|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
574458|NCT00047619|P1|Participant Flow|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
574459|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
574460|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
574461|NCT00047619|O2|Outcome|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
574462|NCT00047619|O1|Outcome|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
574463|NCT00047619|E2|Reported Event|Sham Lavage Group|"sham pulsatile lavage~sham pulsatile lavage: pulsatile lavage to not directed at wound or patient"
574464|NCT00047619|E1|Reported Event|Pulsatile Lavage Group|"pulsatile lavage therapy~Pulsatile Lavage: pulsatile lavage to wound bed"
574465|NCT00047463|B3|Baseline|Total|Total of all reporting groups
574466|NCT00047463|B2|Baseline|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
574467|NCT00047463|B1|Baseline|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
574468|NCT00047463|P2|Participant Flow|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
574469|NCT00047463|P1|Participant Flow|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
574470|NCT00047463|O1|Outcome|All Participants Prior to Randomization|
574471|NCT00047463|O2|Outcome|Placebo-CPAP|Placebo-CPAP: Placebo-CPAP
574472|NCT00047463|O1|Outcome|Continuous Positive Airway Pressure (CPAP)|continuous positive airway pressure (CPAP): a mask treatment for sleep apnea
574473|NCT00047463|O2|Outcome|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
574474|NCT00047463|O1|Outcome|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
574475|NCT00047463|E2|Reported Event|Continuous Positive Airway Pressure|Continuous positive airway pressure is a standard treatment for obstructive sleep apnea that uses pressurized air delivered through a mask to keep the airway open and prevent obstruction during sleep.
574476|NCT00047463|E1|Reported Event|Placebo Continuous Positive Airway Pressure|With placebo continuous positive airway pressure, the subject feels like he/she is receiving the real treatment because of the presence of a blower and mask. However, there is a large leak that prevents the subject from receiving adequate pressurized air to keep the airway open.
574477|NCT00047385|B3|Baseline|Total|Total of all reporting groups
574478|NCT00047385|B2|Baseline|Chest X-ray|Participants undergo chest x-ray examination.
574479|NCT00047385|B1|Baseline|Low-Dose CT|Participants undergo low-dose helical CT examination.
574480|NCT00047385|P2|Participant Flow|Chest X-ray|Participants undergo chest x-ray examination.
574481|NCT00047385|P1|Participant Flow|Low-Dose CT|Participants undergo low-dose helical CT examination.
574485|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574486|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574487|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574488|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574489|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574490|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574491|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574492|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574493|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574494|NCT00047385|O2|Outcome|CXR Screening|Participants randomized to receive three annual chest radiographs.
574495|NCT00047385|O1|Outcome|LDCT Screening|Participants randomized to receive three annual low-dose helical CT exams of the chest.
574496|NCT00047385|E2|Reported Event|Chest X-ray|Participants undergo chest x-ray examination.
574497|NCT00047385|E1|Reported Event|Low-Dose CT|Participants undergo low-dose helical CT examination.
574498|NCT00047320|B1|Baseline|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
574499|NCT00047320|P1|Participant Flow|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
574500|NCT00047320|O1|Outcome|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~thiotepa: Given IV~adjuvant therapy~conventional surgery~neoadjuvant therapy~peripheral blood stem cell transplantation~radiation therapy: craniospinal irradiation"
574501|NCT00047320|E1|Reported Event|Radiation Therapy (CR From Induction)|"Patients will receive 6 cycles of Induction chemotherapy consisting of carboplatin and etoposide (Cycles 1, 3, and 5) alternating with ifosfamide and etoposide (Cycles 2, 4, and 6). The entire length of Induction is 18 weeks unless delay occurs due to myelosuppression or unanticipated toxicity. Each cycle of Induction will begin when ANC > 750/L and platelets > 75,000/L and when off filgrastim (G-CSF) for at least 48 hours. Following the Induction phase (weeks 0-18) those patient in CR will undergo radiation therapy.~carboplatin: Given IV~etoposide: Given IV~ifosfamide: Given IV~radiation therapy: craniospinal irradiation"
574502|NCT00047008|B3|Baseline|Total|Total of all reporting groups
574503|NCT00047008|B2|Baseline|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
574504|NCT00047008|B1|Baseline|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
574505|NCT00047008|P2|Participant Flow|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
574506|NCT00047008|P1|Participant Flow|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
574507|NCT00047008|O2|Outcome|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
574508|NCT00047008|O1|Outcome|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
574509|NCT00047008|E2|Reported Event|Accelerated Fractionation RT + Cisplatin|Accelerated fractionation radiation therapy by concomitant boost with concurrent cisplatin followed by conventional surgery for select patients.
574510|NCT00047008|E1|Reported Event|Standard Fractionation RT + Cisplatin|Standard fractionation radiation therapy with concurrent cisplatin followed by conventional surgery for select patients.
574511|NCT00046930|B3|Baseline|Total|Total of all reporting groups
574512|NCT00046930|B2|Baseline|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
574513|NCT00046930|B1|Baseline|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
574514|NCT00046930|P2|Participant Flow|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
574515|NCT00046930|P1|Participant Flow|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
574516|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
574517|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
574518|NCT00046930|O2|Outcome|Placebo|Induction treatment with daunorubicin, cytarabine and placebo
574519|NCT00046930|O1|Outcome|Zosuquidar|Induction treatment with daunorubicin, cytarabine and zosuquidar
574522|NCT00046930|E5|Reported Event|Placebo Consolidation II|Consolidation with Daunorubicin, Cytarabine and Placebo
574523|NCT00046930|E4|Reported Event|Zosuquidar Consolidation II|Consolidation with Daunorubicin, Cytarabine and Zosuquidar
574524|NCT00046930|E3|Reported Event|Consolidation I|Cytarabine 1500 mg/m2 days 1-6
574525|NCT00046930|E2|Reported Event|Placebo Induction|Induction treatment with daunorubicin, cytarabine and placebo
574526|NCT00046930|E1|Reported Event|Zosuquidar Induction|Induction treatment with daunorubicin, cytarabine and zosuquidar
574527|NCT00046891|B3|Baseline|Total|Total of all reporting groups
574528|NCT00046891|B2|Baseline|Placebo|Placebo: Patients will take 1 tablet BID
574529|NCT00046891|B1|Baseline|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574530|NCT00046891|P2|Participant Flow|Placebo|Placebo: Patients will take 1 tablet BID
574531|NCT00046891|P1|Participant Flow|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574532|NCT00046891|O3|Outcome|Make Decisions|Self-report cognition
574533|NCT00046891|O2|Outcome|Plan Ahead|Self-report cognition
574534|NCT00046891|O1|Outcome|Solve Problems|Self-report cognition
574535|NCT00046891|O3|Outcome|Balance Checkbook|Self-report cognition
574536|NCT00046891|O2|Outcome|Think Clearly|Self-report cognition
574537|NCT00046891|O1|Outcome|Stay Focused|Self-report cognition
574538|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
574539|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574540|NCT00046891|O2|Outcome|Placebo|Median change from baseline to different time points.
574541|NCT00046891|O1|Outcome|Ginko Bibola|Median change from baseline to different time points.
574542|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
574543|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574544|NCT00046891|O2|Outcome|Placebo|Placebo: Patients will take 1 tablet BID
574545|NCT00046891|O1|Outcome|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574546|NCT00046891|E2|Reported Event|Placebo|Placebo: Patients will take 1 tablet BID
574547|NCT00046891|E1|Reported Event|Ginkgo Biloba|Ginkgo Biloba: Patients will take 120 mg per day (60 mg BID)
574548|NCT00046839|B3|Baseline|Total|Total of all reporting groups
574549|NCT00046839|B2|Baseline|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574550|NCT00046839|B1|Baseline|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574551|NCT00046839|P2|Participant Flow|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574552|NCT00046839|P1|Participant Flow|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574553|NCT00046839|O1|Outcome|Experimental: Phase I/II: Celecoxib 200 or 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 or 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574554|NCT00046839|O2|Outcome|Phase I: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
574555|NCT00046839|O1|Outcome|Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.~celecoxib~radiation therapy"
574556|NCT00046839|E2|Reported Event|Experimental: Phase I/II: Celecoxib 400mg BID + RT|"COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574557|NCT00046839|E1|Reported Event|Experimental: Phase I: Celecoxib 200mg BID + RT|"COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression.~Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy."
574558|NCT00046475|B3|Baseline|Total|Total of all reporting groups
574559|NCT00046475|B2|Baseline|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
574560|NCT00046475|B1|Baseline|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
574561|NCT00046475|P3|Participant Flow|Placebo/Midodrine|Participants received Placebo for 2 weeks, followed by 2 weeks of treatment with their optimum dose of Midodrine HCl
574562|NCT00046475|P2|Participant Flow|Midodrine/Placebo|Participants received their optimum dose of Midodrine HCl for 2 weeks, followed by 2 weeks of treatment with Placebo
574563|NCT00046475|P1|Participant Flow|All Enrolled Participants|All patients who were enrolled in this study are included in this population.
574564|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574565|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574566|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574567|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574568|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
574569|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
574570|NCT00046475|O1|Outcome|ITT Population|All patients who were randomly assigned to treatment in the study and have at least one post-randomization OHQ measurement.
574571|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574572|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574573|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574574|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574575|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574576|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574577|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574578|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574579|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574580|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574581|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574582|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574583|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574584|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574585|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574586|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574587|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574588|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574589|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574590|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574591|NCT00046475|O2|Outcome|Placebo|Participants received Placebo daily for 2 weeks
574592|NCT00046475|O1|Outcome|Midodrine HCl|Participants received their optimum dose (5-50mg) of Midodrine HCl for 2 weeks
574593|NCT00046475|E5|Reported Event|Follow-up|Patients were contacted 30 days after last study drug dose to follow up on any ongoing AEs and inquire if there were any new AEs.
574594|NCT00046475|E4|Reported Event|Placebo|Patients received Placebo for 2 weeks.
574595|NCT00046475|E3|Reported Event|Midodrine HCl|Patients received their optimum dose of Midodrine HCl for 2 weeks.
574596|NCT00046475|E2|Reported Event|Titration|Patients received different doses of drug for at least 2 weeks to determine the maximum tolerated dose.
574597|NCT00046475|E1|Reported Event|Screening/Washout|Patients signed the informed consent form and were screened for eligibility. Eligible patients were off drug for 1 week.
574598|NCT00046228|B4|Baseline|Total|Total of all reporting groups
574599|NCT00046228|B3|Baseline|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574600|NCT00046228|B2|Baseline|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574601|NCT00046228|B1|Baseline|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574602|NCT00046228|P3|Participant Flow|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574603|NCT00046228|P2|Participant Flow|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574604|NCT00046228|P1|Participant Flow|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574605|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574606|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574607|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
576002|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
574608|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574609|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574610|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574611|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574612|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574613|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574614|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574615|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574616|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574617|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574618|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574619|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574620|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574621|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574622|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574623|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574624|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574625|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574626|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574627|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574628|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574629|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574630|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574631|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574632|NCT00046228|O3|Outcome|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574633|NCT00046228|O2|Outcome|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574634|NCT00046228|O1|Outcome|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574635|NCT00046228|E3|Reported Event|Reteplase/Abciximab Facilitated PCI Group|Abciximab (bolus) + reteplase (5 U + 5 U double bolus for subjects < 75 years of age; 5 U single bolus for subjects ≥ 75 years of age), abciximab 12 hour infusion initiated prior to PCI
574636|NCT00046228|E2|Reported Event|Abciximab Facilitated PCI Group|Abciximab (bolus) administered as soon as possible after randomization, 12 hour infusion initiated prior to PCI
574637|NCT00046228|E1|Reported Event|Primary PCI Group|Abciximab (bolus + 12 hr infusion) initiated just prior to primary percutaneous coronary intervention (PCI)
574638|NCT00045630|B1|Baseline|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574639|NCT00045630|P1|Participant Flow|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574640|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574641|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574642|NCT00045630|O1|Outcome|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574643|NCT00045630|E1|Reported Event|Gemcitabine, Paclitaxel, Carboplatin Followed by Surgery|Patients receive 3 cycles (1 cycle = 21 days) of neoadjuvant chemotherapy (800 mg/m^2 of gemcitabine IV and 80 mg/m^2 of Paclitaxel IV on days 1 and 8 and Carboplatin IV on day 1), TURBT within 4-8 weeks of chemotherapy, option of proceeding with immediate cystectomy or observation.
574644|NCT00045487|B1|Baseline|OSI-774|Once-daily oral administration for 4 weeks.
574645|NCT00045487|P1|Participant Flow|OSI-774|OSI-774, continuous daily oral administration of 150mg until disease progression or 52 weeks duration. Dose adjustment, reduction by increments of 50mg will be made for dose-limiting toxicity.
574646|NCT00045487|O1|Outcome|OSI-774|Once-daily oral administration for 4 weeks.
574647|NCT00045487|E1|Reported Event|OSI-774|Once-daily oral administration for 4 weeks.
574648|NCT00045305|B1|Baseline|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
574649|NCT00045305|P1|Participant Flow|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
574650|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
574651|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
574652|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
574653|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
576003|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
574654|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
574655|NCT00045305|O1|Outcome|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD.~Cyclosporine: Immunosuppressant~Methotrexate: Antimetabolite"
574656|NCT00045305|E1|Reported Event|Arm I|"Preparative Regimen: Patients underwent photopheresis on two consecutive days and received pentostatin 4 mg/m2/d (total dose = 8 mg/m2) by continuous IV infusion on two consecutive days following photopheresis. Total body irradiation was administered on two consecutive days following pentostatin for a total of 600 cGy given in three 200 cGy fractionated doses.~Transplantation: Unmanipulated allogeneic bone marrow or G-CSF mobilized peripheral blood stem cells were infused on day 0 within 48 hours of completion of TBI. Minimum cell dose was 2 ×106 CD34 cells/kg recipient.~Acute graft-vs-host-disease (GVHD) prophylaxis: Patients received Cyclosporine or Tacrolimus per institutional preference or protocol beginning no later than day -1. Methotrexate (MTX) was administered on day +1 and +3. Mycofenolate mofetil (MMF) was introduced on day 100 and could be tapered and discontinued after 12 months if no active cGVHD."
574657|NCT00045162|B3|Baseline|Total|Total of all reporting groups
574658|NCT00045162|B2|Baseline|Cisplatin + Etoposide|
574659|NCT00045162|B1|Baseline|Cisplatin + Irinotecan|
574660|NCT00045162|P2|Participant Flow|Cisplatin + Etoposide|
574661|NCT00045162|P1|Participant Flow|Cisplatin + Irinotecan|
574662|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
574663|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
574664|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
574665|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
574666|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
574667|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
574668|NCT00045162|O2|Outcome|Cisplatin + Etoposide|
574669|NCT00045162|O1|Outcome|Cisplatin + Irinotecan|
574670|NCT00045162|E2|Reported Event|Cisplatin + Etoposide|
574671|NCT00045162|E1|Reported Event|Cisplatin + Irinotecan|
574672|NCT00044655|B3|Baseline|Total|Total of all reporting groups
574673|NCT00044655|B2|Baseline|Switch|Participants will change medications from medication prescribed at study entry
574674|NCT00044655|B1|Baseline|Stay|Participants will continue taking medication prescribed at study entry
574675|NCT00044655|P2|Participant Flow|Switch|Participants will change medications from medication prescribed at study entry
574676|NCT00044655|P1|Participant Flow|Stay|Participants will continue taking medication prescribed at study entry
574677|NCT00044655|O2|Outcome|Switch|Participants will change medications from medication prescribed at study entry
574678|NCT00044655|O1|Outcome|Stay|Participants will continue taking medication prescribed at study entry
574679|NCT00044655|E2|Reported Event|Switch|Participants will change medications from medication prescribed at study entry
574680|NCT00044655|E1|Reported Event|Stay|Participants will continue taking medication prescribed at study entry
574681|NCT00044512|B1|Baseline|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574682|NCT00044512|P1|Participant Flow|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574683|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574684|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574685|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574686|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574687|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574688|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574689|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574690|NCT00044512|O1|Outcome|Sorafenib 400 mg b.i.d.|Sorafenib (Nexavar, BAY43-9006) 400 mg administered bis in die (bid, twice a day)
574691|NCT00044512|E1|Reported Event|Sorafenib 400 mg b.i.d.|"Sorafenib (Nexavar, BAY43-9006) 400 mg administered b.i.d.Other AE section includes SAEs"
574692|NCT00044213|B5|Baseline|Total|Total of all reporting groups
574693|NCT00044213|B4|Baseline|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
574694|NCT00044213|B3|Baseline|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
574695|NCT00044213|B2|Baseline|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
574696|NCT00044213|B1|Baseline|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
574697|NCT00044213|P4|Participant Flow|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
574698|NCT00044213|P3|Participant Flow|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
574699|NCT00044213|P2|Participant Flow|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
574700|NCT00044213|P1|Participant Flow|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
574701|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
574702|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
574703|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
574704|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
574705|NCT00044213|O4|Outcome|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
574706|NCT00044213|O3|Outcome|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
574707|NCT00044213|O2|Outcome|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
574708|NCT00044213|O1|Outcome|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
574709|NCT00044213|E4|Reported Event|EDTA Placebo + High Dose Vitamin Placebo|Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
574710|NCT00044213|E3|Reported Event|EDTA Placebo + High Dose Vitamin|Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins.
574711|NCT00044213|E2|Reported Event|EDTA + High Dose Vitamin Placebo|Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins.
574712|NCT00044213|E1|Reported Event|EDTA + High Dose Vitamin|Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins.
574713|NCT00044044|B6|Baseline|Total|Total of all reporting groups
574714|NCT00044044|B5|Baseline|Placebo|Oral Capsule matching treatment group taken oce a day
574715|NCT00044044|B4|Baseline|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. One subject who was randomized to the 10 mg haloperidol treatment group did not take any study medication.
574716|NCT00044044|B3|Baseline|80 mg|Lurasidone 80 mg oral tablet taken once a day
574717|NCT00044044|B2|Baseline|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow (overall study) is based on the total number of subjects randomized (356). The number of subjects in the baseline characteristics is based on the safety population (353). All randomized subjects who received at least one dose of study medication were included in the safety analysis. Two subjects who were randomized to the 40 mg treatment group did not take any study medication.
574718|NCT00044044|B1|Baseline|20 mg|Lurasidone 20 mg oral tablet taken once a day
574719|NCT00044044|P5|Participant Flow|Placebo|Oral Capsule matching treatment group taken oce a day. The number of subjects in the participant flow for the placebo group(overall study) is based on the total number of subjects randomized in this treatment group.
574720|NCT00044044|P4|Participant Flow|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day. The number of subjects in the participant flow for the haloperidol 10mg group(overall study) is based on the total number of subjects randomized in this treatment group.
574721|NCT00044044|P3|Participant Flow|80 mg|Lurasidone 80 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 80mg group(overall study) is based on the total number of subjects randomized in this treatment group.
574722|NCT00044044|P2|Participant Flow|40 mg|Lurasidone 40 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 40mg group(overall study) is based on the total number of subjects randomized in this treatment group.
574723|NCT00044044|P1|Participant Flow|20 mg|Lurasidone 20 mg oral tablet taken once a day. The number of subjects in the participant flow for the lurasidone 20mg group(overall study) is based on the total number of subjects randomized in this treatment group.
574724|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
574725|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
574726|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
574727|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
574728|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
574729|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
574730|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
574731|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
574732|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
574733|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
574734|NCT00044044|O5|Outcome|Placebo|Oral Capsule matching treatment group taken oce a day
574735|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
574736|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
574737|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
574738|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
574740|NCT00044044|O4|Outcome|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
574741|NCT00044044|O3|Outcome|80 mg|Lurasidone 80 mg oral tablet taken once a day
574742|NCT00044044|O2|Outcome|40 mg|Lurasidone 40 mg oral tablet taken once a day
574743|NCT00044044|O1|Outcome|20 mg|Lurasidone 20 mg oral tablet taken once a day
574744|NCT00044044|E5|Reported Event|Placebo|Oral Capsule matching treatment group taken oce a day
574745|NCT00044044|E4|Reported Event|10 mg Haloperidol|10 mg Haloperidol overencapsulated tablet taken orally once a day
574746|NCT00044044|E3|Reported Event|80 mg|Lurasidone 80 mg oral tablet taken once a day
574747|NCT00044044|E2|Reported Event|40 mg|Lurasidone 40 mg oral tablet taken once a day
574748|NCT00044044|E1|Reported Event|20 mg|Lurasidone 20 mg oral tablet taken once a day
574749|NCT00044005|B4|Baseline|Total|Total of all reporting groups
574750|NCT00044005|B3|Baseline|Lurasidone 80mg|Lurasidone 80mg oral tablets
574751|NCT00044005|B2|Baseline|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
574752|NCT00044005|B1|Baseline|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
574753|NCT00044005|P3|Participant Flow|Lurasidone 80mg|Lurasidone 80mg oral tablets
574754|NCT00044005|P2|Participant Flow|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
574755|NCT00044005|P1|Participant Flow|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
574756|NCT00044005|O3|Outcome|Lurasidone 80mg|Lurasidone 80mg oral tablets
574757|NCT00044005|O2|Outcome|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
574758|NCT00044005|O1|Outcome|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
574759|NCT00044005|E3|Reported Event|Lurasidone 80mg|Lurasidone 80mg oral tablets
574760|NCT00044005|E2|Reported Event|Lurasidone 40 mg|Lurasidone 40 mg oral tablets
574761|NCT00044005|E1|Reported Event|Lurasidone 20 mg|Lurasdione 20 mg oral tablets
574762|NCT00043979|B3|Baseline|Total|Total of all reporting groups
574763|NCT00043979|B2|Baseline|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
574764|NCT00043979|B1|Baseline|Arm 1-Sibling Donors|Donors (n=30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.
574765|NCT00043979|P3|Participant Flow|Recipients Tacrolimus /Sirolimus Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received tacrolimus & sirolimus for GVHD prophylaxis."
574766|NCT00043979|P2|Participant Flow|Recipients Cyclosporine GVHD Prophylaxis|"In period 1 recipients received EPOCH-F/chemotherapy. In period 2 recipients received peripheral blood stem transplant.~Post transplant recipients received cyclosporine for GVHD prophylaxis."
574767|NCT00043979|P1|Participant Flow|Sibling Donors|Donors (n = 30) were matched first degree relatives who were eligible to donate peripheral blood stem cells.In period 1 they donated cells.
574768|NCT00043979|O2|Outcome|Recipients -Tacrolimus/Sirolimus GVHD Prophylaxis|
574769|NCT00043979|O1|Outcome|Recipients -Cyclosporine GVHD Prophylaxis|
574770|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
574771|NCT00043979|O1|Outcome|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
574772|NCT00043979|E1|Reported Event|Arm 2-Recipients|Recipients (n=30) were enrolled to receive peripheral blood stem cells (PBSC) and receive either cyclosporine or tacrolimus and sirolimus for graft versus host disease (GVHD) prophylaxis.
574773|NCT00043186|B10|Baseline|Total|Total of all reporting groups
574774|NCT00043186|B9|Baseline|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574775|NCT00043186|B8|Baseline|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574776|NCT00043186|B7|Baseline|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574777|NCT00043186|B6|Baseline|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574778|NCT00043186|B5|Baseline|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574779|NCT00043186|B4|Baseline|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574780|NCT00043186|B3|Baseline|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574781|NCT00043186|B2|Baseline|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574782|NCT00043186|B1|Baseline|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574783|NCT00043186|P9|Participant Flow|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574784|NCT00043186|P8|Participant Flow|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574785|NCT00043186|P7|Participant Flow|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574786|NCT00043186|P6|Participant Flow|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574822|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574787|NCT00043186|P5|Participant Flow|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574788|NCT00043186|P4|Participant Flow|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574789|NCT00043186|P3|Participant Flow|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574790|NCT00043186|P2|Participant Flow|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574791|NCT00043186|P1|Participant Flow|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574792|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574793|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574794|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574795|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574796|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574797|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574798|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574799|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574800|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574801|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574802|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574803|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574804|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574805|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574806|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574807|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574808|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574809|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574810|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574811|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574812|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574813|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574814|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574815|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574816|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574817|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574818|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574819|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574820|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574821|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574823|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574824|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574825|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574826|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574827|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574828|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574829|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574830|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574831|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574832|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574833|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574834|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574835|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574836|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574837|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574838|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574839|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574840|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574841|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574842|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574843|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574844|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574845|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574846|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574847|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574848|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574849|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574850|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574851|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574852|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574853|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574854|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574855|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574856|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574857|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574858|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574859|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574860|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574861|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574862|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574863|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574864|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574865|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574866|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574867|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574868|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574869|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574870|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574871|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574872|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574873|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574874|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574875|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574876|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574877|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574878|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574879|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574880|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574881|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574882|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574883|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574884|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574885|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574886|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574887|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574888|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574889|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574890|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574891|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574892|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575377|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
574893|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574894|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574895|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574896|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574897|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574898|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574899|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574900|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574901|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574902|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574903|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574904|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574905|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574906|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574907|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574908|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574909|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574910|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574911|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574912|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574913|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574914|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574915|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574916|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574917|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574918|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574919|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574920|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574921|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574922|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574923|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574924|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574925|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574926|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574927|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575378|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
574928|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574929|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574930|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574931|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574932|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574933|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574934|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574935|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574936|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574937|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574938|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574939|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574940|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574941|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574942|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574943|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574944|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574945|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574946|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574947|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574948|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574949|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574950|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574951|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574952|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574953|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574954|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574955|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574956|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574957|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574958|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574959|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574960|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574961|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574962|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575379|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
574963|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574964|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574965|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574966|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574967|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574968|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574969|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574970|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574971|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574972|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574973|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574974|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574975|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574976|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574977|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574978|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574979|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574980|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574981|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574982|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574983|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574984|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574985|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574986|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574987|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574988|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574989|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574990|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
574991|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
574992|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574993|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
574994|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574995|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
574996|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
574997|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575380|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
574998|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
574999|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575000|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575001|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575002|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575003|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575004|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575005|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575006|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575007|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575008|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575009|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575010|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575011|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575012|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575013|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575014|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575015|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575016|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575017|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575018|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575019|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575020|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575021|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575022|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575023|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575024|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575025|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575026|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575027|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575028|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575029|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575030|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575031|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575032|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575381|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
575033|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575034|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575035|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575036|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575037|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575038|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575039|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575040|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575041|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575042|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575043|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575044|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575045|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575046|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575047|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575048|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575049|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575050|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575051|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575052|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575053|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575054|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575055|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575056|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575057|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575058|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575059|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575060|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575061|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575062|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575063|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575064|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575065|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575066|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575067|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575382|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a Protease Inhibitor (PI)
575068|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575069|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575070|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575071|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575072|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575073|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575074|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575075|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575076|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575077|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575078|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575079|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575080|NCT00043186|O1|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575081|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575082|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575083|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575084|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575085|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575086|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575087|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575088|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575089|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575090|NCT00043186|O9|Outcome|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575091|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575092|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575093|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575094|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575095|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575096|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575097|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575098|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575099|NCT00043186|O8|Outcome|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575100|NCT00043186|O7|Outcome|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575101|NCT00043186|O6|Outcome|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575102|NCT00043186|O5|Outcome|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575383|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
575103|NCT00043186|O4|Outcome|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575104|NCT00043186|O3|Outcome|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575105|NCT00043186|O2|Outcome|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575106|NCT00043186|O1|Outcome|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575107|NCT00043186|E9|Reported Event|Alendronate 70 mg|Participants received open-label alendronate 70 mg tablets orally once a week through Month 24. From Month 24 to Month 48 participants received no treatment.
575108|NCT00043186|E8|Reported Event|Denosumab 210 mg Q6M|Participants received denosumab 210 mg SC every 6 months until Month 21 and then placebo every 6 months from Month 24 through Month 42.
575109|NCT00043186|E7|Reported Event|Denosumab 100 mg Q6M|Participants received denosumab 100 mg SC every 6 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575110|NCT00043186|E6|Reported Event|Denosumab 60 mg Q6M|Participants received denosumab 60 mg SC every 6 months until Month 42.
575111|NCT00043186|E5|Reported Event|Denosumab 14 mg Q6M|Participants received denosumab 14 mg SC every 6 months (Q6M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575112|NCT00043186|E4|Reported Event|Denosumab 30 mg Q3M|Participants received denosumab 30 mg SC every 3 months until Month 21 then placebo SC every 6 months at Month 24 and Month 30 and then denosumab 60 mg SC every 6 months at Month 36 and Month 42.
575113|NCT00043186|E3|Reported Event|Denosumab 14 mg Q3M|Participants received denosumab 14 mg SC every 3 months until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575114|NCT00043186|E2|Reported Event|Denosumab 6 mg Q3M|Participants received denosumab 6 mg SC every 3 months (Q3M) until Month 21 and then denosumab 60 mg every 6 months from Month 24 through Month 42.
575115|NCT00043186|E1|Reported Event|Placebo|Participants received double-blind subcutaneous (SC) placebo injections every 3 months until month 21 and then placebo SC injections once every 6 months from Month 24 through Month 42.
575116|NCT00042991|B8|Baseline|Total|Total of all reporting groups
575117|NCT00042991|B7|Baseline|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575118|NCT00042991|B6|Baseline|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575119|NCT00042991|B5|Baseline|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575120|NCT00042991|B4|Baseline|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575121|NCT00042991|B3|Baseline|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575122|NCT00042991|B2|Baseline|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575123|NCT00042991|B1|Baseline|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575124|NCT00042991|P7|Participant Flow|Stratum-2: 100 mg/m^2 of Gefitinib + Radiation + EIACD|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575125|NCT00042991|P6|Participant Flow|Stratum-1B: 375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575126|NCT00042991|P5|Participant Flow|Stratum-1B: 250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575127|NCT00042991|P4|Participant Flow|Stratum-1B: 100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed, incompletely resected supertentorial malignant gliomas and NOT receiving enzyme inducing anticonvulsant drugs (EIACD), who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575128|NCT00042991|P3|Participant Flow|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 375 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575129|NCT00042991|P2|Participant Flow|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 250 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
575130|NCT00042991|P1|Participant Flow|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with newly diagnosed brain stem glioma who were treated at Dose 100 mg/m^2 of Gefitinib+Radiation, where Gefitinib was administered orally once daily.
576004|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
575131|NCT00042991|O1|Outcome|Stratum IB and Stratum II|Activation and mutations of EGFR have been associated with many cancers. In this secondary objective, we identify how many patients have activated EGFR and this requires a tumor sample from patients, which is only available from supratentorial malignant glioma patients treated on Stratum IB and Stratum II.
575132|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
575133|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
575134|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
575135|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
575136|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
575137|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
575138|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
575139|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
575140|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
575141|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
575142|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
575143|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
575144|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
575145|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
575146|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
575147|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
575148|NCT00042991|O4|Outcome|Dose 375 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 375 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight of 12 patients had adequate PK samples for the PK evaluation.
575149|NCT00042991|O3|Outcome|Dose 100 mg/m^2 of Gefitinib|This cohort includes all Phase-I patients treated at 100 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Eight (8) of 10 patients had adequate PK samples for the PK evaluation.
575150|NCT00042991|O2|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase I)|This cohort includes all Phase-I patients treated at 250 mg/m^2 of Gefitinib regardless of diagnosis; that is, this group includes both brain stem gliomas and supratentorial malignant gliomas. Only six of 11 patients had adequate PK samples for the PK evaluation.
575151|NCT00042991|O1|Outcome|Dose 250 mg/m^2 of Gefitinib (Phase II, Brain Stem Gliomas)|Brain Stem Glioma patients treated on the Phase-II trial. Seven patients were treated during Phase-I at the Phase-II dose, and thus eligible for the Phase-II trial, and included in this part of the report. Only 18 patients had samples for the PK evaluation.
575152|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575153|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575154|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575155|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575156|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575157|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575158|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575159|NCT00042991|O1|Outcome|Stratum 1A-Dose 250 mg/m^2 of Gefitinib+Radiation|This analysis includes patients with newly diagnosed Brain Stem Glioma patients who received Dose 250 mg/m^2 of Gefitinib+Radiation.
575160|NCT00042991|O3|Outcome|Stratum 1A-375 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 375 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
575161|NCT00042991|O2|Outcome|Stratum 1A-250 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 250 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
575162|NCT00042991|O1|Outcome|Stratum 1A-100 mg/m^2 of Gefitinib + Radiation|These are patients with brain stem glioma who were treated during the Phase-I trial of Radiation+Dose 100 mg/m^2 of Gefitinib, where Gefitinib was administered orally once daily.
575163|NCT00042991|E7|Reported Event|Stratum II at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2 who are receiving EIACD
575164|NCT00042991|E6|Reported Event|Stratum IB at Dose 375 mg/m^2|Patients with STMG treated at 375 mg/m2
575165|NCT00042991|E5|Reported Event|Stratum IB at Dose 250 mg/m^2|Patients with STMG treated at 250 mg/m2
575166|NCT00042991|E4|Reported Event|Stratum IB at Dose 100 mg/m^2|Patients with STMG treated at 100 mg/m2
575167|NCT00042991|E3|Reported Event|Stratum IA at Dose 375 mg/m^2|Brain Stem Glioma patients treated at 375 mg/m2
575168|NCT00042991|E2|Reported Event|Stratum IA at Dose 250 mg/m^2|Brain Stem Glioma patients treated at 250 mg/m2
575169|NCT00042991|E1|Reported Event|Stratum IA at Dose 100 mg/m^2|Brain Stem Glioma patients treated at 100 mg/m2
575170|NCT00042939|B3|Baseline|Total|Total of all reporting groups
575171|NCT00042939|B2|Baseline|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575172|NCT00042939|B1|Baseline|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575173|NCT00042939|P2|Participant Flow|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575174|NCT00042939|P1|Participant Flow|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575175|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575234|NCT00040937|B1|Baseline|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
575176|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575177|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575178|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575179|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575180|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575181|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575182|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575183|NCT00042939|O2|Outcome|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575184|NCT00042939|O1|Outcome|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575231|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
575232|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
575233|NCT00041067|E1|Reported Event|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
575185|NCT00042939|E2|Reported Event|Arm B: Irinotecan/Docetaxel/Cetuximab|"Patients received Cetuximab intravenously once a week for 6 weeks. On day 1 of cycle 1 only, an initial dose of 400 mg/m² (over 120 minutes) was administered. Thereafter, a once-a-week maintenance dose of 250 mg/m² (infused over 60 minutes), was given. The infusion rate never exceeded 5 ml/minute.~On the day of the initial dose, the administration of Cetuximab was followed by the administration of docetaxel, after a 60-minute observation period. (The observation period was 30 minutes following maintenance doses.) Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. Cetuximab was administered once a week for 6 consecutive weeks. A cycle of treatment was 6 weeks."
575186|NCT00042939|E1|Reported Event|Arm A: Irinotecan/Docetaxel|"Docetaxel was administered intravenously over 60 minutes at a dose of 35 mg/m². Docetaxel was diluted in 100-150 ml of infusion solution. After the completion of the docetaxel infusion, irinotecan was administered intravenously over 30 minutes at a dose of 50 mg/m².~Chemotherapy was administered once a week (days 1, 8, 15, 22) for 4 consecutive weeks followed by 2 weeks rest. This constituted a cycle of treatment. Patients were evaluated after 2 cycles."
575187|NCT00041938|B3|Baseline|Total|Total of all reporting groups
575188|NCT00041938|B2|Baseline|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575189|NCT00041938|B1|Baseline|Aspirin|Aspirin : 325 mg per day
575190|NCT00041938|P2|Participant Flow|Warfarin|Warfarin : International Normalized Ratio (INR) 2.5-3.0; target INR 2.75
575191|NCT00041938|P1|Participant Flow|Aspirin|Aspirin : 325 mg per day
575192|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575193|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575194|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575195|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575196|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575197|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575198|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575199|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575200|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575201|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575202|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575203|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575204|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575205|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575206|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575207|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575208|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575209|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575210|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575211|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575212|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575213|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575214|NCT00041938|O2|Outcome|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575215|NCT00041938|O1|Outcome|Aspirin|Aspirin : 325 mg per day
575216|NCT00041938|E2|Reported Event|Warfarin|Warfarin : INR 2.5-3.0; target INR 2.75
575217|NCT00041938|E1|Reported Event|Aspirin|Aspirin : 325 mg per day
575218|NCT00041080|B3|Baseline|Total|Total of all reporting groups
575219|NCT00041080|B2|Baseline|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
575220|NCT00041080|B1|Baseline|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
575221|NCT00041080|P2|Participant Flow|Grp - 2|Tamoxifen 20mg orally twice daily for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
575222|NCT00041080|P1|Participant Flow|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
575223|NCT00041080|O2|Outcome|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
575224|NCT00041080|O1|Outcome|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
575225|NCT00041080|E2|Reported Event|Grp - 2|Tamoxifen 20mg orally for up to 12 28-day cycles until progression or adverse effect prohibited additional therapy.
575226|NCT00041080|E1|Reported Event|Grp - 1|Thalidomide 200mg orally daily with weekly escalation of 100mg to a maximum dose of 400mg until progression or additional therapy prohibited further therapy.
575227|NCT00041067|B1|Baseline|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
575228|NCT00041067|P1|Participant Flow|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
575229|NCT00041067|O1|Outcome|Docetaxel + Vinorelbine + G-CSF + Trastuzumab|
575230|NCT00041067|O1|Outcome|Trastuzumab, Docetaxel, Vinorelbine and Filgrastim|"Trastuzumab, docetaxel, vinorelbine and filgrastim~docetaxel : 60 mg/m^2 on Day 1 of 21-day cycles~vinorelbine : 27.5 mg/m^2 on Days 8 and 15~filgrastim : 5 microg/kg/day on Days 2 to 21~trastuzumab : 4 mg/kg by IV over a 90-minute period on Day 1 of the first cycle, then weekly 2 mg/kg by IV over a 30-minute period"
575295|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
575235|NCT00040937|P1|Participant Flow|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
575236|NCT00040937|O1|Outcome|Treatment Arm|thalidomide/dexamethasone followed by tandem melphalan peripheral blood stem cell transplantation (with cyclophosphamide and filgrastim or sargramostim support) and prednisone/thalidomide maintenance
575237|NCT00040937|O1|Outcome|Induction/PBSC Mobilization|
575238|NCT00040937|E3|Reported Event|Prednisone + Thalidomide|
575239|NCT00040937|E2|Reported Event|Autologous PBSCT|
575240|NCT00040937|E1|Reported Event|Induction/PBSC Mobilization|
575241|NCT00042432|B3|Baseline|Total|Total of all reporting groups
575242|NCT00042432|B2|Baseline|Placebo|Placebo administered orally once daily
575243|NCT00042432|B1|Baseline|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
575244|NCT00042432|P2|Participant Flow|Placebo|Placebo administered orally once daily
575245|NCT00042432|P1|Participant Flow|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
575246|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
575247|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
575248|NCT00042432|O2|Outcome|Placebo|Placebo administered orally once daily
575249|NCT00042432|O1|Outcome|Cinacalcet (AMG 073)|Cinacalcet administered orally once daily with dose titrated starting at 30 mg
575250|NCT00042432|E2|Reported Event|Cinacalcet|
575251|NCT00042432|E1|Reported Event|Placebo|
575252|NCT00042224|B3|Baseline|Total|Total of all reporting groups
575253|NCT00042224|B2|Baseline|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575254|NCT00042224|B1|Baseline|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575255|NCT00042224|P2|Participant Flow|2 Medication Monotherapy|Clozapine: Patients with psychotic symptoms will receive clozapine
575256|NCT00042224|P1|Participant Flow|1 Electroconvulsive Therapy With Medication|"Electroconvulsive Therapy (ECT): ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Clozapine: Patients with psychotic symptoms will receive clozapine"
575257|NCT00042224|O2|Outcome|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575258|NCT00042224|O1|Outcome|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575259|NCT00042224|E2|Reported Event|Medication Monotherapy|"Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575260|NCT00042224|E1|Reported Event|Electroconvulsive Therapy With Medication|"Procedure/Surgery: Electroconvulsive Therapy (ECT) ECT will be used to augment clozapine in schizophrenic patients who continue to have psychotic symptoms despite optimal treatment with clozapine.~Drug: Clozapine Patients with psychotic symptoms will receive clozapine~Other Names:~• Clozaril"
575261|NCT00041756|B6|Baseline|Total|Total of all reporting groups
575262|NCT00041756|B5|Baseline|200 mg PG-530742|200 mg PG-530742 dosed BID
575263|NCT00041756|B4|Baseline|100 mg PG-530742|100 mg PG-530742 dosed BID
575264|NCT00041756|B3|Baseline|50 mg PG-530742|50 mg PG-530742 dosed BID
575265|NCT00041756|B2|Baseline|25 mg PG-530742|25 mg PG-530742 dosed BID
575266|NCT00041756|B1|Baseline|Placebo Tablet|Placebo tablet dosed BID
575267|NCT00041756|P5|Participant Flow|200 mg PG-530742|200 mg PG-530742 dosed BID
575268|NCT00041756|P4|Participant Flow|100 mg PG-530742|100 mg PG-530742 dosed BID
575269|NCT00041756|P3|Participant Flow|50 mg PG-530742|50 mg PG-530742 dosed BID
575270|NCT00041756|P2|Participant Flow|25 mg PG-530742|25 mg PG-530742 dosed BID
575271|NCT00041756|P1|Participant Flow|Placebo Tablet|Placebo tablet dosed BID
575272|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
575273|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
575274|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
575275|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
575276|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
575277|NCT00041756|O5|Outcome|200 mg PG-530742|200 mg PG-530742 dosed BID
575278|NCT00041756|O4|Outcome|100 mg PG-530742|100 mg PG-530742 dosed BID
575279|NCT00041756|O3|Outcome|50 mg PG-530742|50 mg PG-530742 dosed BID
575280|NCT00041756|O2|Outcome|25 mg PG-530742|25 mg PG-530742 dosed BID
575281|NCT00041756|O1|Outcome|Placebo Tablet|Placebo tablet dosed BID
575282|NCT00041756|E5|Reported Event|200 mg PG-530742|200 mg PG-530742 dosed BID
575283|NCT00041756|E4|Reported Event|100 mg PG-530742|100 mg PG-530742 dosed BID
575284|NCT00041756|E3|Reported Event|50 mg PG-530742|50 mg PG-530742 dosed BID
575285|NCT00041756|E2|Reported Event|25 mg PG-530742|25 mg PG-530742 dosed BID
575286|NCT00041756|E1|Reported Event|Placebo Tablet|Placebo tablet dosed BID
575287|NCT00041717|B3|Baseline|Total|Total of all reporting groups
575288|NCT00041717|B2|Baseline|Placebo|Placebo : Placebo
575289|NCT00041717|B1|Baseline|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
575290|NCT00041717|P2|Participant Flow|Placebo|Placebo : Placebo
575291|NCT00041717|P1|Participant Flow|Fampridine-SR 50mg/Day|Fampridine-sustained release (SR) : 25mg bid (twice daily)
575292|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
575293|NCT00041717|O1|Outcome|Fampridine-SR 50mg/Day|Fampridine-SR : 25mg bid (twice daily)
575294|NCT00041717|O2|Outcome|Placebo|Placebo : Placebo
575307|NCT00041132|B1|Baseline|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
575308|NCT00041132|P1|Participant Flow|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
575309|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
575310|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
575311|NCT00041132|O1|Outcome|Hyper-CVAD + MTX/Ara-C + Rituximab|"21-day cycles of Hyper-CVAD and high-dose methotrexate/Ara-C are alternated beginning with Hyper-CVAD for a maximum of 8 cycles. Rituximab is given for cycles 1-6.~Hyper-CVAD (cycles 1,3,5,7): rituximab 375 mg/m^2 on day 1, mesna 600 mg/m^2 on days 2-4, cyclophosphamide 300 mg/m^2 on days 2-4, doxorubicin 16.6 mg/m^2/day on days 5-7, vincristine 1.4 mg/m^2 on days 5 and 12, dexamethasone 40 mg on days 2-5 and 12-15, and G-CSF 5 ug/kg on days 8-21.~Methotrexate/Ara-C (cycles 2,4,6,8): rituximab 375 mg/m^2 on day 1, methotrexate 1000 mg/m^2 over days 2-3, Ara-C 12 g/m^2 over days 3-4, leucovorin 170 mg over days 3-5, and G-CSF 5 ug/kg on days 5-21."
575312|NCT00041132|E1|Reported Event|Hyper-CVAD + MTX/Ara-C + Rituximab|
575313|NCT00040742|B5|Baseline|Total|Total of all reporting groups
575314|NCT00040742|B4|Baseline|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
575315|NCT00040742|B3|Baseline|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575316|NCT00040742|B2|Baseline|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575317|NCT00040742|B1|Baseline|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
575318|NCT00040742|P4|Participant Flow|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
575319|NCT00040742|P3|Participant Flow|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575320|NCT00040742|P2|Participant Flow|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575321|NCT00040742|P1|Participant Flow|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
575322|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
575323|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575324|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575325|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
575326|NCT00040742|O4|Outcome|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
575327|NCT00040742|O3|Outcome|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575328|NCT00040742|O2|Outcome|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575329|NCT00040742|O1|Outcome|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
575330|NCT00040742|E4|Reported Event|1.5g Ginger|"Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally"
575331|NCT00040742|E3|Reported Event|1.0g Ginger|"Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575433|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575332|NCT00040742|E2|Reported Event|0.5g Ginger|"Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~ginger extract: Given orally~placebo: Given orally"
575333|NCT00040742|E1|Reported Event|Placebo|"Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.~placebo: Given orally"
575334|NCT00040664|B1|Baseline|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
575335|NCT00040664|P4|Participant Flow|12-18 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 12-18 years
575336|NCT00040664|P3|Participant Flow|6-11 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 6-11 years
575337|NCT00040664|P2|Participant Flow|2-5 Years FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD), 2-5 years
575338|NCT00040664|P1|Participant Flow|Overall Fosamprenavir (FPV)/Ritonavir(RTV)|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
575339|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575340|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
575341|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
575342|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
575343|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
575344|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
575345|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
575346|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
575347|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
575348|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
575349|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
575350|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
575351|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575352|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
575353|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
575354|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
575355|NCT00040664|O1|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575356|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years vs. Historical Adult Data
575357|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years vs. Historical Adult Data
575358|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years vs. Historical Adult Data
575359|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years vs. Historical Adult Data
575360|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575361|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
575362|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
575363|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
575364|NCT00040664|O2|Outcome|PI-Experienced|Participants treated with equal to or less than 3 PIs (any length of time)
575365|NCT00040664|O1|Outcome|PI-Naive|Participants with equal to or less than 1 week of treatment with a PI
575366|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575367|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
575368|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
575369|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
575370|NCT00040664|O4|Outcome|FPV/RTV 1400/200 mg Once Daily (Tablet), 12-18 Years|FPV/RTV 1400/200 mg once daily (tablet), 12-18 years
575371|NCT00040664|O3|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 12-18 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 12-18 years
575372|NCT00040664|O2|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 6-11 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 6-11 years
575373|NCT00040664|O1|Outcome|FPV/RTV 30/6 mg/kg Once Daily (Suspension), 2-5 Years|FPV/RTV 30/6 mg/kg once daily (suspension), 2-5 years
575374|NCT00040664|O1|Outcome|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
575375|NCT00040664|O2|Outcome|FPV Oral Suspension|Fosamprenavir 50 mg/mL oral suspension/ritonavir 80 mg/mL oral solution once daily
575384|NCT00040664|E1|Reported Event|FPV/RTV|Fosamprenavir (FPV) 700 mg tablets or 50 mg/mL oral suspension/ritonavir (RTV) 100 mg capsules or 80 mg/mL oral solution once daily (QD)
575385|NCT00040365|B1|Baseline|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575386|NCT00040365|P1|Participant Flow|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575387|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575388|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575389|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575390|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575391|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575392|NCT00040365|O1|Outcome|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575393|NCT00040365|E1|Reported Event|Amifostine|1000 mg for the first 18 patients. 2000 mg for the last 12 patients. The syringe of amifostine will be connected to a rectal enema bottle for administration. Administered slowly over 30-60 seconds with the patient in recumbent position 30-45 minutes prior to each radiation treatment (33-39 doses).
575394|NCT00039195|B1|Baseline|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
575395|NCT00039195|P1|Participant Flow|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
575396|NCT00039195|O1|Outcome|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
575397|NCT00039195|E1|Reported Event|Induction R-CHOPac Therapy|Induction R-CHOPac Therapy for patients with B-Cell Lymphoma
575398|NCT00039130|B1|Baseline|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575399|NCT00039130|P1|Participant Flow|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575400|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575434|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575435|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575436|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
576005|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
575401|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575402|NCT00039130|O1|Outcome|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575403|NCT00039130|E1|Reported Event|Rituximab With High Intensity Chemotherapy|"Cycle1: Cyclophosphamide 100 mg/m^2/day (d) IV (d 1-5), Prednisone 60 mg/m^2/d oral (d 1-7), Allopurinal 300 mg/d oral (d 1-14)~Cycle 2, 4 & 6 (21 day): Ifosfamide 800 mg/m^2/d (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 25 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Cytarabine 1000 mg/m^2/d over 2 h (d 4-5), Etoposide 80 mg/m^2.d over 1 h (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 50 mg/m^2 d 8 cycle 2 only, 375 mg/m^2/d (d 10, 12 cycle 2, d 8 cycle 4 & 6)~Cycle 3, 5 & 7 (21 day): Cyclophosphamide 200 mg/m^2/day (d) IV (d 1-5), Dexamethasone 10 mg/m^2/d (d1-5), Methotrexate 150 mg/m^2 load, then 1.35 g/m^2 over 23.5 h (d 1), Leucovorin 50 mg/m^2 36 h after methotrexate (d 2) then 10 mg/m^2 every 6 h, Vincristine 2 mg push (d 1), Doxorubicin 25 mg/m^2/d (d 4-5), Filgrastim 5 mg/kg/d (d 7-21 as needed), Rituximab 375 mg/m^2/d (d 8)"
575404|NCT00039871|B1|Baseline|PegIntron Plus Rebetol|
575405|NCT00039871|P1|Participant Flow|PegIntron Plus Rebetol|
575406|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
575407|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
575408|NCT00039871|O1|Outcome|PegIntron Plus Rebetol|
575409|NCT00039871|E1|Reported Event|PegIntron Plus Rebetol|
575410|NCT00039741|B5|Baseline|Total|Total of all reporting groups
575411|NCT00039741|B4|Baseline|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
575412|NCT00039741|B3|Baseline|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
575413|NCT00039741|B2|Baseline|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
575414|NCT00039741|B1|Baseline|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
575415|NCT00039741|P4|Participant Flow|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
575416|NCT00039741|P3|Participant Flow|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
575417|NCT00039741|P2|Participant Flow|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
575418|NCT00039741|P1|Participant Flow|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
575419|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575420|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575421|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575422|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575423|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575424|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575425|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575426|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575427|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575428|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575429|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575430|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575431|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575432|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575437|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575438|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575439|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575440|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575441|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575442|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575443|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575444|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575445|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575446|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575447|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575448|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575449|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575450|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575451|NCT00039741|O4|Outcome|Switch Point (30K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=30,000 copies/mL, regardless of drug class.
575452|NCT00039741|O3|Outcome|Switch Point (1K)|Participants randomized to switch to second-line therapy when HIV-1 RNA is >=1,000 copies/mL, regardless of drug class.
575453|NCT00039741|O2|Outcome|Drug Class/NNRTI|Participants randomized to receive an NNRTI-based regimen, regardless of switch point.
575454|NCT00039741|O1|Outcome|Drug Class/PI|Participants randomized to receive a PI-based regimen, regardless of switch point.
575455|NCT00039741|E4|Reported Event|NNRTI/30K|2 NRTIs plus an NNRTI with a regimen change recommended when viral load reaches 30,000 copies/ml or higher
575456|NCT00039741|E3|Reported Event|PI/30K|Two NRTIs plus a PIwith a regimen change recommended when viral load is 30,000 copies/ml or higher
575457|NCT00039741|E2|Reported Event|NNRTI/1K|2 NRTIs plus a nonnucleoside reverse transcriptase inhibitor (NNRTI) with a regimen change recommended when viral load reaches 1,000 copies/ml or higher
575458|NCT00039741|E1|Reported Event|PI/1K|Two nucleoside reverse transcriptase inhibitors (NRTI) plus a protease inhibitor (PI)with a regimen change recommended when viral load is 1000 copies/ml or higher
575459|NCT00039377|B1|Baseline|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
575460|NCT00039377|P4|Participant Flow|Patients Who Did Not Undergo Transplant for Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575461|NCT00039377|P3|Participant Flow|Patients Without HLA-matched Sibling Donors in Course V|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575462|NCT00039377|P2|Participant Flow|Patients With HLA-matched Sibling Donor in Course 5|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575463|NCT00039377|P1|Participant Flow|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
575464|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575488|NCT00038948|E1|Reported Event|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
575489|NCT00038857|B1|Baseline|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
575465|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575466|NCT00039377|O2|Outcome|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575467|NCT00039377|O1|Outcome|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575468|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
575469|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
575470|NCT00039377|O1|Outcome|Entire Cohort|All participants treatment on this study, see the Detailed Description for treatment information.
575471|NCT00039377|E3|Reported Event|Patients Who Did Not Undergo Transplant|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients who are not candidates for PBSCT receive etoposide IV over 4 hours and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC once or twice a day beginning on day 14 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575472|NCT00039377|E2|Reported Event|Patients Without HLA-matched Sibling Donors|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients without an HLA-matched sibling donor receive etoposide IV continuously and cytarabine IV over 2 hours on days 1-4. Patients also receive G-CSF SC beginning on day 14 and continuing until PBSC collection is complete. Patients receive imatinib mesylate PO twice daily beginning after completion of PBSC collection and continuing until 3 days before PBSCT. Patients then undergo TBI 2-3 times daily on days -8 to -5. Patients receive etoposide IV over 4 hours on day -4 and cyclophosphamide IV over 2 hours on day -2. Patients undergo PBSCT on day 0. Patients receive G-CSF SC beginning on day 0 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575473|NCT00039377|E1|Reported Event|Patients With HLA-matched Sibling Donor|Patients undergo courses I-IV as in Detailed Description. Beginning 3-10 days after completion of course IV, patients with an HLA-matched sibling donor undergo total body irradiation (TBI) 2-3 times daily on days -7 to -4. Patients receive etoposide IV over 4 hours on day -3. Patients then undergo PBSCT on day 0. Patients then receive graft-vs-host disease prophylaxis with tacrolimus IV continuously on days -1 to 56 (or IV continuously on days -1 to 14 and then PO or IV every 12 hours on days 15-56) followed by a taper. Patients also receive methotrexate IV on days 1, 3, and 6, and filgrastim (G-CSF) subcutaneously (SC) beginning on day 4 and continuing until blood counts recover. Patients then undergo course VI as in Detailed Description.
575474|NCT00038948|B3|Baseline|Total|Total of all reporting groups
575475|NCT00038948|B2|Baseline|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
575476|NCT00038948|B1|Baseline|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
575477|NCT00038948|P2|Participant Flow|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
575478|NCT00038948|P1|Participant Flow|SRL Conversion in Stable Renal Transplant Recipients|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy.
575479|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor therapy
575480|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
575481|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor therapy
575482|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression to Sirolimus-based immunosuppression
575483|NCT00038948|O4|Outcome|CNI Continuation Strata >40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
575484|NCT00038948|O3|Outcome|SRL Conversion Strata >40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in renal transplant recipients.
575485|NCT00038948|O2|Outcome|CNI Continuation Strata 20.0-40.0 mL/Min|Continued calcineurin inhibitor immunosuppression therapy in renal transplant recipients.
575486|NCT00038948|O1|Outcome|SRL Conversion Strata 20.0-40.0 mL/Min|Conversion from calcineurin inhibitor immunosuppression therapy to Sirolimus-based immunosuppression therapy in stable renal transplant recipients
575487|NCT00038948|E2|Reported Event|CNI Continuation in Stable Renal Transplant Recipients|Continued calcineurin inhibitor immunosuppression therapy
576006|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
575490|NCT00038857|P1|Participant Flow|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
575491|NCT00038857|O1|Outcome|Melphalan + Thiotepa + Fludarabine + Rabbit ATG + CD34 PBPC|Melphalan 140 mg/m^2 given for one day. Thiotepa 10 mg/kg given for one day. Fludarabine 40 mg/m^2 given daily for four days. Rabbit ATG 1.5 mg/kg given daily for four days. Infusion of CD34+ Selected Cells given on Day 0.
575492|NCT00038857|E1|Reported Event|CD34 PBPC|Melphalan 140 mg/m^2 given IV for one day. Thiotepa 10 mg/kg given IV for one day. Fludarabine 40 mg/m^2 given IV daily for four days. Rabbit ATG 1.5 mg/kg given IV daily for four days. Stem Cell Infusion of CD34+ Selected Cells given on Day 0.
575493|NCT00038610|B1|Baseline|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575494|NCT00038610|P1|Participant Flow|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575495|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575496|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575497|NCT00038610|O1|Outcome|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575498|NCT00038610|E1|Reported Event|Hyper-CVAD + Imatinib|Imatinib 600 mg orally days 1-14, course 1, & 600 mg daily days 1-14 (daily if tolerated course 1), even courses. Cyclophosphamide 300 mg/m^2 intravenous (IV) for 6 doses days 1-3, odd courses. Doxorubicin 50 mg/m^2 IV day 4; Vincristine 2 mg IV days 4 & 11; & Dexamethasone 40 mg IV or orally daily days 1-4 & 11-14 odd courses 1, 3, 5, 7. Methotrexate 12 mg intrathecally (6 mg if via Ommaya reservoir) day 2, odd courses and 200 mg/m^2 IV over 2 hours followed by 800 mg/m^2 over 22 hours day 1 of even courses. Cytarabine 100 mg intrathecally day 7 for odd courses and 3 gm/m^2 IV every 12 hours for 4 doses days 2-3 for even courses. Mesna 600 mg/m^2 IV daily, odd courses. G-CSF 10 mcg/kg/day after completion of chemotherapy until neutrophil recovery to 1 x 109/L or higher for all courses.
575499|NCT00038467|B3|Baseline|Total|Total of all reporting groups
575500|NCT00038467|B2|Baseline|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575501|NCT00038467|B1|Baseline|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575502|NCT00038467|P2|Participant Flow|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575503|NCT00038467|P1|Participant Flow|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
576007|NCT00031460|O2|Outcome|Placebo|Identical volume as acyclovir.
575504|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575505|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575506|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575507|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575508|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575509|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575510|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575511|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575512|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575513|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575514|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575515|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575516|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575517|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575518|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575519|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575520|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575521|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575522|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575523|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575567|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575524|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575525|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575526|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575527|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575528|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575529|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575530|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575531|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575532|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575533|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575534|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575535|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575536|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575537|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575538|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575539|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575540|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575541|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575542|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575543|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575568|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575544|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575545|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575546|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575547|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575548|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575549|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575550|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575551|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575552|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575553|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575554|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575555|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575556|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575557|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575558|NCT00038467|O2|Outcome|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575559|NCT00038467|O1|Outcome|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575560|NCT00038467|E2|Reported Event|Tamoxifen|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 mg or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received the same dose of tamoxifen tablet-in-capsule orally once daily for the remainder of 5-year period.
575561|NCT00038467|E1|Reported Event|Exemestane|Participants diagnosed with breast cancer who remained disease-free after previously receiving 2 to 3 years of tamoxifen 20 milligram (mg) or 30 mg tablet-in-capsule orally once daily as per standard medical practice, received exemestane (Aromasin) 25 mg tablet-in-capsule orally once daily for the remainder of 5-year period.
575562|NCT00038103|B3|Baseline|Total|Total of all reporting groups
575563|NCT00038103|B2|Baseline|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575564|NCT00038103|B1|Baseline|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575565|NCT00038103|P2|Participant Flow|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575566|NCT00038103|P1|Participant Flow|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575921|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
575569|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575570|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575571|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575572|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575573|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575574|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575575|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575576|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575577|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575578|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575579|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575580|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575581|NCT00038103|O2|Outcome|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575582|NCT00038103|O1|Outcome|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575583|NCT00038103|E2|Reported Event|Combination (Exemestane + Celecoxib)|oral doses to be taken with food (25 mg tablet exemestane once daily; celecoxib 2 x 200 mg tablets twice daily)
575584|NCT00038103|E1|Reported Event|Exemestane (Exemestane Alone)|oral dose exemestane taken with food (25 mg tablet once daily)
575585|NCT00037830|B4|Baseline|Total|Total of all reporting groups
575586|NCT00037830|B3|Baseline|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575587|NCT00037830|B2|Baseline|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
575588|NCT00037830|B1|Baseline|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
575589|NCT00037830|P3|Participant Flow|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575590|NCT00037830|P2|Participant Flow|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
575591|NCT00037830|P1|Participant Flow|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
575592|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575593|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575594|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575595|NCT00037830|O1|Outcome|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575596|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575597|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575598|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575599|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575600|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575601|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575602|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575603|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575604|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575605|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575606|NCT00037830|O2|Outcome|Delayed-Start Group|Group that was randomized to receive placebo for 24 weeks
575607|NCT00037830|O1|Outcome|Early-Start Group|Group that was randomized to receive GM1 ganglioside 24 weeks
575608|NCT00037830|E3|Reported Event|Comparison Group|This group of PD patients who received standard of care were followed for one to two years to provide comparative information about natural disease progression. This group was not statistically compared to the treatment groups since this group was not randomized.
575609|NCT00037830|E2|Reported Event|Delayed-Start Group|Phase I: Thiry eight subjects were randomized to receive placebo for 24 weeks.
575610|NCT00037830|E1|Reported Event|Early-Start Group|Phase I: Thirty nine subjects were randomized to receive GM1 for 24 weeks.
575922|NCT00032630|E2|Reported Event|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
575611|NCT00036569|B1|Baseline|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575612|NCT00036569|P1|Participant Flow|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575613|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575614|NCT00036569|O2|Outcome|QOL Score at Follow-up|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575615|NCT00036569|O1|Outcome|QOL Score at Baseline|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575616|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575617|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575618|NCT00036569|O1|Outcome|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575619|NCT00036569|E1|Reported Event|Interferon Alfa|0.3 mg/kg subcutaneously once a week for 4 weeks beginning 2-10 weeks after completion of radiation therapy and continued until disease progression or one of the other off study criteria.
575620|NCT00036270|B3|Baseline|Total|Total of all reporting groups
575621|NCT00036270|B2|Baseline|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575622|NCT00036270|B1|Baseline|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575623|NCT00036270|P2|Participant Flow|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575624|NCT00036270|P1|Participant Flow|Exemestane|Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.
575625|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575626|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575627|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575628|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575629|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575630|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575631|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575632|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575633|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575634|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575635|NCT00036270|O2|Outcome|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575636|NCT00036270|O1|Outcome|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years.
575637|NCT00036270|E2|Reported Event|Exemestane|Exemestane (Aromasin®) 25 mg QD for 5 years
575638|NCT00036270|E1|Reported Event|Tamoxifen Followed by Exemestane|Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.
575639|NCT00035932|B4|Baseline|Total|Total of all reporting groups
575640|NCT00035932|B3|Baseline|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575641|NCT00035932|B2|Baseline|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575642|NCT00035932|B1|Baseline|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575643|NCT00035932|P3|Participant Flow|LPV / RTV|"lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575644|NCT00035932|P2|Participant Flow|ATV 400 mg / SQV|"ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575645|NCT00035932|P1|Participant Flow|ATV 300 mg / RTV|"atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575923|NCT00032630|E1|Reported Event|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
575646|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575647|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575648|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575649|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575650|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575651|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575652|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575653|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575654|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575655|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575656|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575657|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575658|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575659|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575660|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575661|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575662|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575663|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575664|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575665|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575666|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575667|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575668|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575669|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575670|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575671|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575672|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575673|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575674|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575675|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575924|NCT00032591|B3|Baseline|Total|Total of all reporting groups
575676|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575677|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575678|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575679|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575680|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575681|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575682|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575683|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575684|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575685|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575686|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575687|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575688|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575689|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575690|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575691|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575692|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575693|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575694|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575695|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575696|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575697|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575698|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575699|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575700|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575701|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575702|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
575703|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
575704|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = 56 [20])
575705|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (CD4 Cell Count Change from Baseline [cells/mm3] Mean [SE] = 80 [21])
575706|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
575707|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
575708|NCT00035932|O2|Outcome|ATV 400 mg / SQV|ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.57 [0.3])
575709|NCT00035932|O1|Outcome|ATV 300 mg / RTV|ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice treated participants (HIV RNA change from baseline [log10 c/mL] Mean [SE] = -1.91 [0.19])
575710|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575711|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575712|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575713|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575714|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575715|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575716|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575717|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575718|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575719|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575720|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575721|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575722|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575723|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575724|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575725|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575726|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575727|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575728|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575729|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575730|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575731|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575732|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575733|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575734|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575735|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575736|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575925|NCT00032591|B2|Baseline|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575737|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575738|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575739|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575740|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575741|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575742|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575743|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575744|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575745|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575746|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575747|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575748|NCT00035932|O2|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575749|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575750|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575751|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575752|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575753|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575754|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575755|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575756|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575757|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575758|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575759|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575760|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575761|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575762|NCT00035932|O3|Outcome|LPV / RTV|"LPV/RTV 400/100 mg + TDF 300 mg + nucleoside of choice~LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575763|NCT00035932|O2|Outcome|ATV 400 mg / SQV|"ATV 400 mg + SQV 1200 mg + TDF 300 mg + nucleoside of choice~ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575764|NCT00035932|O1|Outcome|ATV 300 mg / RTV|"ATV 300 mg + RTV 100 mg + TDF 300 mg + nucleoside of choice~ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study"
575765|NCT00035932|E3|Reported Event|LPV/RTV|lopinavir (LPV)/RTV 400/100 mg + TDF 300 mg + nucleoside of choice LPV/RTV twice daily, TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
575766|NCT00035932|E2|Reported Event|ATV400/SQV|ATV 400 mg + saquinavir (SQV) 1200 mg + TDF 300 mg + nucleoside of choice ATV, SQV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
575767|NCT00035932|E1|Reported Event|ATV300/RTV|atazanavir (ATV) 300 mg + ritonavir (RTV) 100 mg + tenofovir (TDF) 300 mg + nucleoside of choice ATV , RTV, and TDF once daily, nucleoside per label 48 Weeks and then for as long as subject is in need of therapy through study
575768|NCT00035815|B3|Baseline|Total|Total of all reporting groups
575769|NCT00035815|B2|Baseline|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575770|NCT00035815|B1|Baseline|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575771|NCT00035815|P2|Participant Flow|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575772|NCT00035815|P1|Participant Flow|IGF-1|The insulin-like growth factor type 1 (IGF-1) arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575773|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575774|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575775|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575776|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575777|NCT00035815|O2|Outcome|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575778|NCT00035815|O1|Outcome|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575779|NCT00035815|E2|Reported Event|Placebo|Placebo group received the equal volume (based on kg of body weight) of the inert suspension vehicle in which the IGF-1 was suspended.
575780|NCT00035815|E1|Reported Event|IGF-1|The IGF-1 arm was the active treatment group. They received 0.05 mg/kg body weight administered subcutaneously twice daily.
575781|NCT00035555|B4|Baseline|Total|Total of all reporting groups
575782|NCT00035555|B3|Baseline|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575783|NCT00035555|B2|Baseline|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575784|NCT00035555|B1|Baseline|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575785|NCT00035555|P3|Participant Flow|Cyclosporine Regimen|Cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575786|NCT00035555|P2|Participant Flow|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575831|NCT00033917|P1|Participant Flow|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
575832|NCT00033917|O4|Outcome|Placebo - IVH|Randomized to placebo; had IVH
575833|NCT00033917|O3|Outcome|Placebo - no IVH|Randomized to placebo - no IVH
575787|NCT00035555|P1|Participant Flow|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575788|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575789|NCT00035555|O2|Outcome|Belatacept:Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575790|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575791|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575792|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575793|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575794|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575834|NCT00033917|O2|Outcome|Indomethacin - IVH|Randomized to indomethacin; had IVH
575835|NCT00033917|O1|Outcome|Indomethacin - no IVH|Subjects randomized to indomethacin and had no IVH
575836|NCT00033917|O2|Outcome|Placebo|Group randomized to an equal volume of placebo
575837|NCT00033917|O1|Outcome|Indomethacin|subjects randomized to early low dose indomethacin
575992|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575795|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575796|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575797|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575798|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575799|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575800|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575801|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575802|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575838|NCT00033917|E2|Reported Event|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
575839|NCT00033917|E1|Reported Event|IVH Negative Indomethacin|Those subjects with no evidence for intraventricular hemorrhage (IVH) at 6 - 12 postnatal hours. These subjects were randomized to early low-dose indomethacin (0.1 mg/kg/d for 3 doses).
575840|NCT00033657|B3|Baseline|Total|Total of all reporting groups
575803|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575804|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575805|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575806|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575807|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575808|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575809|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575810|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575841|NCT00033657|B2|Baseline|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575811|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575812|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575813|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575814|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575815|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575816|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575817|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575818|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575842|NCT00033657|B1|Baseline|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575819|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575820|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575821|NCT00035555|O3|Outcome|Cyclosporine Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575822|NCT00035555|O2|Outcome|Belatacept: Less Intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575823|NCT00035555|O1|Outcome|Belatacept: More Intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575824|NCT00035555|E3|Reported Event|Cyclosporin Regimen|The cyclosporine regimen was designed to achieve a specified range of target serum concentrations consistent with current medical practice for the duration of the study. The initial daily dose was 7±3 mg/kg. Subsequent doses were adjusted to maintain a predefined range of serum concentrations: 1st month, target level 150-400 ng/mL; after 1st month, target level of 150-300 ng/mL. Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575825|NCT00035555|E2|Reported Event|Belatacept: More-intensive (MI) Regimen|The MI regimen aimed to achieve projected serum trough concentrations of belatacept of 20 μg/mL through Day 99, and 5 μg/mL through Day 183 (10 mg/kg on Days 1, 5, 15, 29, 43, 57, 71, 85, 113, 141 and 169). After Day 169, doses were reassigned to achieve projected trough serum concentrations of 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 197). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575826|NCT00035555|E1|Reported Event|Belatacept: Less-intensive (LI) Regimen|The LI regimen was designed to achieve projected trough serum concentrations of belatacept of 20 μg/mL through Day 29, and approximately 5 μg/mL through Day 99 (10 mg/kg on Days 1, 15, 29, 57 and 85). After Day 85, these subjects were reallocated and dosed to achieve projected trough serum concentrations of either 2 or 0.25 μg/mL (5 mg/kg every 4 or 8 weeks starting on Day 113). Participants initially received mycophenolate mofetil (MMF), 2 g/d orally or ≥1 doses intravenously (IV),depending on the investigators decision. The first MMF dose was administered preoperatively; subsequent doses were administered in 2 or 3 divided doses, every 8-12 hours, beginning as soon as the participant was able to tolerate medications by mouth. All participants also received induction therapy (2 doses) with basiliximab IV and daily corticosteroids.
575827|NCT00033917|B3|Baseline|Total|Total of all reporting groups
575828|NCT00033917|B2|Baseline|Placebo|Group randomized to an equal volume of placebo
575829|NCT00033917|B1|Baseline|Indomethacin|subjects randomized to early low dose indomethacin
575830|NCT00033917|P2|Participant Flow|IVH Negative Placebo|These subjects also had no evidence for IVH at 6 - 12 hours. They were randomized to an equal volume of placebo.
575843|NCT00033657|P2|Participant Flow|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575844|NCT00033657|P1|Participant Flow|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575845|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575846|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575847|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575848|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575849|NCT00033657|O2|Outcome|Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575850|NCT00033657|O1|Outcome|Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575851|NCT00033657|E4|Reported Event|Adjuvant_Paclitaxel / Irinotecan / RT ( Arm B)|
575852|NCT00033657|E3|Reported Event|Adjuvant_Cisplatin / Irinotecan / RT ( Arm A)|Adjuvant chemotherapy toxicities in treated patients
575853|NCT00033657|E2|Reported Event|Neoadjuvant_Paclitaxel / Cisplatin / RT (Arm B)|"Days 1 - 35 : Concurrent RT and Paclitaxel/Cisplatin Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Paclitaxel 50 mg/m² (1 hr) days 1, 8, 15, 22, 29. Cisplatin 30 mg/m² days 1, 8, 15, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy.~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: paclitaxel 175 mg/m² and cisplatin 75 mg/m² day 1 of three 3-week cycles."
575854|NCT00033657|E1|Reported Event|Neoadjuvant_Cisplatin / Irinotecan / RT (Arm A)|"Days 1 - 35 : Concurrent radiation therapy and Cisplatin / Irinotecan Chemotherapy. Radiotherapy 45 Gy administered at 1.8 Gy per day, 5 days a week for 5 weeks. Cisplatin 30 mg/m² days 1, 8, 22, 29. Irinotecan 65 mg/m² days 1, 8, 22, 29. Chemotherapy should begin within 24 hours of start of radiotherapy~Days 63 - 77 : Surgical Resection At least 28 days after surgical resection, begin adjuvant chemotherapy: cisplatin 30 mg/m² and irinotecan 65 mg/m² days 1 and 8 of three 3-week cycles"
575855|NCT00033631|B3|Baseline|Total|Total of all reporting groups
575856|NCT00033631|B2|Baseline|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575857|NCT00033631|B1|Baseline|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575858|NCT00033631|P2|Participant Flow|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575859|NCT00033631|P1|Participant Flow|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575860|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575861|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575862|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575863|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575864|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575865|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575866|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575867|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575868|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575869|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575870|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575871|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575872|NCT00033631|O2|Outcome|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 79.2 Gy in 44 fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575873|NCT00033631|O1|Outcome|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 fractions. All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575874|NCT00033631|E2|Reported Event|79.2 Gy|79.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 44 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 79.2 Gy.
575875|NCT00033631|E1|Reported Event|70.2 Gy|70.2 Gy 3D-CRT/IMRT: Radiation will be delivered via 3D conformal radiation therapy (3D-CRT) or intensity modulated radiation therapy (IMRT) in 1.8 Gy minimum dose fractions to a total of 70.2 Gy in 39 Fractions . All fields treated once daily, five fractions per week. No more than 2% of the planning target volume and none of the clinical target volume may receive less than 70.2 Gy.
575876|NCT00033540|B1|Baseline|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575877|NCT00033540|P1|Participant Flow|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575878|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575879|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575880|NCT00033540|O1|Outcome|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575881|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575882|NCT00033540|O1|Outcome|Capecitabine + Gemcitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575883|NCT00033540|E1|Reported Event|Gemcitabine and Capecitabine|Capecitabine 650 mg/m^2 twice daily (BID), by mouth (PO) at 12 hour intervals, Days 1-14, every 21 days; Gemcitabine 1000 mg/m^2, intravenous (IV) over 100 minutes, Days 1, 8, every 21 days
575884|NCT00033514|B3|Baseline|Total|Total of all reporting groups
575885|NCT00033514|B2|Baseline|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
575886|NCT00033514|B1|Baseline|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
575887|NCT00033514|P2|Participant Flow|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
575888|NCT00033514|P1|Participant Flow|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
575889|NCT00033514|O1|Outcome|Treatment Phase 1|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 100 mg daily on Course 1 Day 2. After three weeks patients who have not experienced specific adverse events, dose will be escalated to 150 mg daily. Patients who have experienced specific adverse events dose will remain 100 mg daily or dose reduced as necessary per protocol."
575890|NCT00033514|O1|Outcome|Treatment Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride:150 mg daily."
575891|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
575892|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
575893|NCT00033514|O1|Outcome|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 150 mg daily."
575894|NCT00033514|E1|Reported Event|Treatment Phase 1 Plus Phase 2|"trastuzumab: Day 1 4mg/kg IV 2 mg/kg IV weekly.~erlotinib hydrochloride: 50mg daily, 100 mg daily and 150 mg daily."
575895|NCT00033371|B3|Baseline|Total|Total of all reporting groups
575896|NCT00033371|B2|Baseline|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
575897|NCT00033371|B1|Baseline|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
575898|NCT00033371|P2|Participant Flow|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
575899|NCT00033371|P1|Participant Flow|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
575900|NCT00033371|O2|Outcome|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
575901|NCT00033371|O1|Outcome|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
575902|NCT00033371|E2|Reported Event|Arm II: Celecoxib and Eflornithine|Celecoxib 400 mg PO BID and Eflornithine PO daily 0.5 g/m^2/day rounded down to the nearest 250 mg dose (body surface area (BSA) of < 1.4 = 500 mg/day; BSA of 1.5 - 2.0 = 750 mg/day; BSA of 2.1 - 2.5 = 1000 mg/day; BSA of > 2.6 = 1,250 mg/day). Treatment continues for 6 months (up to 200 days).
575903|NCT00033371|E1|Reported Event|Arm I: Celecoxib and Placebo|Celecoxib 400 mg orally twice daily (PO BID) and Placebo once a day. Treatment continues for 6 months (up to 200 days).
575904|NCT00033293|B3|Baseline|Total|Total of all reporting groups
575905|NCT00033293|B2|Baseline|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
575906|NCT00033293|B1|Baseline|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
575907|NCT00033293|P2|Participant Flow|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
575908|NCT00033293|P1|Participant Flow|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
575909|NCT00033293|O2|Outcome|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
575910|NCT00033293|O1|Outcome|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
575911|NCT00033293|E2|Reported Event|Arm II (Chemotherapy, Observation)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning on day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hour on day 0. Treatment repeats every 4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 months and then every other day for 7-15 months.~Patients do not receive therapeutic immune globulin. Patients with unresponsive opsoclonus-myoclonus-ataxia syndrome after 2 months or progression after 6 months may cross over to arm I."
575912|NCT00033293|E1|Reported Event|Arm I (Chemotherapy, Immunoglobulin Therapy)|"Patients with intermediate-risk or high-risk neuroblastoma receive chemotherapy (including cyclophosphamide) according to the standard of care for the stage of primary neuroblastoma, beginning day 0. Patients with low-risk neuroblastoma (and not receiving other chemotherapy) receive cyclophosphamide IV over 1 hr on day 0. Treatment repeats every 4 wks for 6 courses in the absence of disease progression or unacceptable toxicity. All patients receive oral prednisone twice daily for 3 mths and then every other day for 7-15 mths.~Patients receive therapeutic immune globulin IV on days -2 and -1, at wks 4, 8, 12, 16, 20, and 24, and then at mths 8, 10, and 12 after therapy. Treatment continues in the absence of disease progression or unacceptable toxicity. Patients with no response after 6 months go off treatment. In case of progression of opsoclonus-myoclonus-ataxia (OMA) during evaluation, patient will be switched to another steroid, corticotropin-releasing hormone (ACTH)."
575913|NCT00032630|B3|Baseline|Total|Total of all reporting groups
575914|NCT00032630|B2|Baseline|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
575915|NCT00032630|B1|Baseline|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
575916|NCT00032630|P2|Participant Flow|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
575917|NCT00032630|P1|Participant Flow|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
575918|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
575919|NCT00032630|O1|Outcome|On Pump|Coronary artery bypass performed on a non beating heart using a heart-lung machine
575920|NCT00032630|O2|Outcome|Off Pump|Coronary artery bypass performed on a beating heart with no heart-lung machine
575993|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
575926|NCT00032591|B1|Baseline|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575927|NCT00032591|P2|Participant Flow|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575928|NCT00032591|P1|Participant Flow|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575929|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575930|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575931|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575932|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575933|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575934|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575935|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575936|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575937|NCT00032591|O2|Outcome|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575938|NCT00032591|O1|Outcome|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575939|NCT00032591|E2|Reported Event|High Quality Anticoagulation Management (HQACM)|High quality anticoagulation management (HQACM) with conventional monthly testing
575940|NCT00032591|E1|Reported Event|Patient Self-Testing (PST)|Patient Self-Testing (PST) of prothrombin time by international normalized ratio (PT-INR or INR) with weekly testing
575941|NCT00032487|B3|Baseline|Total|Total of all reporting groups
575942|NCT00032487|B2|Baseline|Arm 2/Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Standard glycemic control
575943|NCT00032487|B1|Baseline|Arm 1/Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
575944|NCT00032487|P2|Participant Flow|Intensive Glycemic Control|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
575945|NCT00032487|P1|Participant Flow|Standard Glycemic Control|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
575946|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
575947|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
575948|NCT00032487|O2|Outcome|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
575949|NCT00032487|O1|Outcome|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
575950|NCT00032487|E2|Reported Event|Arm 2|Intensive glycemic control lower HbA1c below 6.0%. Metformin 500 mg (go up to 2000 mg) Rosiglitazone 4 mg bid Glimepiride 8 mg Insulin 1 unit 9 lbs add one injection to Arm 1
575951|NCT00032487|E1|Reported Event|Arm 1|Standard glycemic control to maintain HbA1c between 8.0-9.0%. Metformin 500 mg Rosiglitazone 4 mg Glimepiride 2 mg Insulin 1 unit 9 lbs
575952|NCT00031694|B1|Baseline|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
575953|NCT00031694|P1|Participant Flow|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
575954|NCT00031694|O1|Outcome|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
575955|NCT00031694|E1|Reported Event|Treatment (Paclitaxel, Bryostatin 1)|"Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.~paclitaxel: Given IV~bryostatin 1: Given IV~pharmacological study: Correlative studies"
575956|NCT00031551|B3|Baseline|Total|Total of all reporting groups
575957|NCT00031551|B2|Baseline|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
575994|NCT00031486|E2|Reported Event|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575995|NCT00031486|E1|Reported Event|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575996|NCT00031460|B3|Baseline|Total|Total of all reporting groups
575997|NCT00031460|B2|Baseline|Placebo|Identical volume as acyclovir.
575998|NCT00031460|B1|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
575999|NCT00031460|P2|Participant Flow|Placebo|Identical volume as acyclovir.
575958|NCT00031551|B1|Baseline|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
575959|NCT00031551|P2|Participant Flow|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
575960|NCT00031551|P1|Participant Flow|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
575961|NCT00031551|O1|Outcome|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
575962|NCT00031551|O2|Outcome|Pilot Study: Day 9 After CT Scores|
575963|NCT00031551|O1|Outcome|Pilot Study: Baseline Scores|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
575964|NCT00031551|O1|Outcome|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
575965|NCT00031551|O2|Outcome|Main Study: Placebo Mouthwash|"Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first.~Placebo"
575966|NCT00031551|O1|Outcome|Main Study: Etanercept Mouthwash|"Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Etanercept"
575967|NCT00031551|E2|Reported Event|Pilot Study|Participants were enrolled in the pilot study to collect descriptive data about pain perception and laboratory techniques.
575968|NCT00031551|E1|Reported Event|Main Study Participants|"Participants were randomized to one of the following two interventions but the study was not unblinded.~Etanercept 2.5 mg in 20cc mouthwash is swished and spit by the participant every 6 hours. The experimental mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant (BMT) Day +14, whichever occurs first.~Placebo 20cc mouthwash is swished and spit by the participant every 6 hours. The placebo mouthwash starts one day before conditioning chemotherapy is administered to the participant and continues until oral pain intensity and stomatitis severity scores are both 0, or by bone marrow transplant day (BMT) Day +14, whichever occurs first."
575969|NCT00031486|B3|Baseline|Total|Total of all reporting groups
575970|NCT00031486|B2|Baseline|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575971|NCT00031486|B1|Baseline|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575972|NCT00031486|P2|Participant Flow|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575973|NCT00031486|P1|Participant Flow|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575974|NCT00031486|O3|Outcome|Total|
575975|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575976|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575977|NCT00031486|O3|Outcome|Total|
575978|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575979|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575980|NCT00031486|O3|Outcome|Total|
575981|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575982|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets 3 times a day for 90 days
575983|NCT00031486|O3|Outcome|Total|
575984|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575985|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
575986|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575987|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
575988|NCT00031486|O3|Outcome|Total|
575989|NCT00031486|O2|Outcome|Placebo|four placebo tablets (identical to active drug in appearance) 3 times a day for 90 days
575990|NCT00031486|O1|Outcome|Valacyclovir|four 500 mg tablets taken 3 times a day for 90 days
575991|NCT00031486|O3|Outcome|Total|
576008|NCT00031460|O1|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576009|NCT00031460|E2|Reported Event|Placebo|Identical volume as acyclovir.
576010|NCT00031460|E1|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576011|NCT00031447|B3|Baseline|Total|Total of all reporting groups
576012|NCT00031447|B2|Baseline|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576013|NCT00031447|B1|Baseline|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576014|NCT00031447|P2|Participant Flow|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576015|NCT00031447|P1|Participant Flow|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576016|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576017|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576018|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576019|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576020|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576021|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576022|NCT00031447|O2|Outcome|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576023|NCT00031447|O1|Outcome|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576024|NCT00031447|E2|Reported Event|Acyclovir|Oral suspension 300 mg/m^2/dose TID for 6 months.
576025|NCT00031447|E1|Reported Event|Placebo|Identical to oral acyclovir suspension in appearance and taste. Volume is identical to the administration of active drug.
576026|NCT00030992|B1|Baseline|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
576027|NCT00030992|P1|Participant Flow|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
576028|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
576029|NCT00030992|O1|Outcome|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
576030|NCT00030992|E1|Reported Event|BMS-247550|One hour infusion on five successive days (daily x 5) every three weeks. Starting dose of 6 mg/m^2/day for a total per cycle dose of 30 mg/m^2
576031|NCT00030901|B3|Baseline|Total|Total of all reporting groups
576032|NCT00030901|B2|Baseline|Placebo|Patients receive oral placebo once daily for 3 years
576033|NCT00030901|B1|Baseline|Selenium|Patients receive oral selenium once daily for 3 years
576034|NCT00030901|P3|Participant Flow|Placebo|Patients receive oral placebo once daily for 3 years
576035|NCT00030901|P2|Participant Flow|Selenium|Patients receive oral selenium once daily for 3 years
576036|NCT00030901|P1|Participant Flow|All Patients|
576037|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
576038|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
576039|NCT00030901|O2|Outcome|Placebo|Patients receive oral placebo once daily for 3 years
576040|NCT00030901|O1|Outcome|Selenium|Patients receive oral selenium once daily for 3 years
576041|NCT00030901|E2|Reported Event|Placebo|Patients receive oral placebo once daily for 3 years
576042|NCT00030901|E1|Reported Event|Selenium|Patients receive oral selenium once daily for 3 years
576043|NCT00030823|B1|Baseline|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
576044|NCT00030823|P1|Participant Flow|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
576045|NCT00030823|O1|Outcome|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
576046|NCT00030823|E1|Reported Event|Vaccine|Patients receive Globo-H-GM2-Lewis-y-MUC1-32(aa)-sTn(c)-TF(c)-Tn(c)-KLH conjugate vaccine with QS21 adjuvant subcutaneously weekly on weeks 1, 2, 3, 7, and 19.
576047|NCT00030147|B5|Baseline|Total|Total of all reporting groups
576048|NCT00030147|B4|Baseline|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
576049|NCT00030147|B3|Baseline|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
576050|NCT00030147|B2|Baseline|Placebo|Placebo skin patch and placebo tablets for eight weeks
576051|NCT00030147|B1|Baseline|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
576052|NCT00030147|P4|Participant Flow|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
576053|NCT00030147|P3|Participant Flow|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
576054|NCT00030147|P2|Participant Flow|Placebo|Placebo skin patch and placebo tablets for eight weeks
576055|NCT00030147|P1|Participant Flow|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
576056|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
576057|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
576058|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
576059|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
576060|NCT00030147|O4|Outcome|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
576061|NCT00030147|O3|Outcome|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
576062|NCT00030147|O2|Outcome|Placebo|Placebo skin patch and placebo tablets for eight weeks
576063|NCT00030147|O1|Outcome|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
576064|NCT00030147|E4|Reported Event|Rimostil|Rimostil (phytoestrogen) 1000mg twice a day and placebo skin patch for eight weeks
576065|NCT00030147|E3|Reported Event|Raloxifene|Raloxifene (Evista) 60 mg per day and placebo skin patch for eight weeks
576066|NCT00030147|E2|Reported Event|Placebo|Placebo skin patch and placebo tablets for eight weeks
576067|NCT00030147|E1|Reported Event|Estradiol|Transdermal estradiol 17-beta estradiol 100 micrograms a day by skin patch and placebo tablets for eight weeks
576068|NCT00029172|B1|Baseline|Case Management|
576069|NCT00029172|P1|Participant Flow|Case Management|
576070|NCT00029172|O1|Outcome|Case Management|
576071|NCT00029172|E1|Reported Event|Case Management|
576072|NCT00029146|B3|Baseline|Total|Total of all reporting groups
576073|NCT00029146|B2|Baseline|Non-surgical Group|Receives best current practice medical therapy
576074|NCT00029146|B1|Baseline|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576075|NCT00029146|P2|Participant Flow|Non-surgical Group|Receives best current practice medical therapy
576076|NCT00029146|P1|Participant Flow|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576077|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576078|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576079|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576080|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576081|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576082|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576083|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576084|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576085|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576086|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576087|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576088|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576089|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576090|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576091|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576092|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576093|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576094|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576095|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576096|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576097|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576098|NCT00029146|O2|Outcome|Non-surgical Group|Receives best current practice medical therapy
576099|NCT00029146|O1|Outcome|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576100|NCT00029146|E2|Reported Event|Non-surgical Group|Receives best current practice medical therapy
576101|NCT00029146|E1|Reported Event|Surgical Group|Assigned to undergo extracranial-intracranial arterial bypass in addition to best current practice medical therapy
576102|NCT00029107|B3|Baseline|Total|Total of all reporting groups
576103|NCT00029107|B2|Baseline|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
576104|NCT00029107|B1|Baseline|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
576105|NCT00029107|P2|Participant Flow|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
576106|NCT00029107|P1|Participant Flow|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
576107|NCT00029107|O2|Outcome|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
576108|NCT00029107|O1|Outcome|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
576109|NCT00029107|E2|Reported Event|Standard Therapy|Receives standard therapy. After 6 months, they are eligibile to cross over and receive four weekly infusions of rituximab.
576110|NCT00029107|E1|Reported Event|Immediate Treatment|Patients receive treatment with four weekly infusions of rituximab immediately following randomization.
576165|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576166|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
577699|NCT00003631|E2|Reported Event|Group B - Intermediate Prognostic Group|
576111|NCT00028769|B1|Baseline|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576112|NCT00028769|P1|Participant Flow|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576113|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576114|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576115|NCT00028769|O1|Outcome|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576116|NCT00028769|E1|Reported Event|CAD + Chemo|Patients receive Combined androgen deprivation (CAD) therapy with LHRH agonist (goserelin acetate or leuprolide acetate) sq/IM q 1-4 months depending on dose chosen by the treating physician and oral antiandrogen (250 mg/tid of flutamide, 50 mg/d of bicalutamide or 300 mg/d for 30 days then 150 mg/d of nilutamide) given continuously until disease progression and Chemotherapy (4 cycles of estramustine 280 mg orally 3 times daily and etoposide 50 mg/m^2 daily for 14 days of each 21-day cycle, with paclitaxel 135 mg/m^2 given intravenously within 1 hour on day 2 of each cycle)
576117|NCT00028262|B1|Baseline|Drug Cystagon and N-acetylcysteine|
576118|NCT00028262|P1|Participant Flow|Drug Cystagon and N-acetylcysteine|
576119|NCT00028262|O1|Outcome|Drug Cystagon and N-acetylcysteine|
576120|NCT00028262|E1|Reported Event|Drug Cystagon and N-acetylcysteine|
576121|NCT00028093|B3|Baseline|Total|Total of all reporting groups
576122|NCT00028093|B2|Baseline|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
576123|NCT00028093|B1|Baseline|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
576124|NCT00028093|P2|Participant Flow|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
576125|NCT00028093|P1|Participant Flow|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
576126|NCT00028093|O2|Outcome|Peginterferon|
576127|NCT00028093|O1|Outcome|Peginterferon+Ribavirin|
576128|NCT00028093|E2|Reported Event|Peginterferon Alone|peginterferon-alpha 2a, 180 ug subcutaneous once weekly for the first 4 weeks of therapy, after which peginterferon was continued at the same dose and weight-based oral ribavirin was added and continued for an additional 44 weeks.
576129|NCT00028093|E1|Reported Event|Peginterferon+Ribavirin|peginterferon alpha-2a, 180 ug subcutaneous once weekly and weight-based oral ribavirin (1000 mg daily for patients less than 75 kg and 1200 mg daily for patients greater than 75 kg) for 48 weeks
576130|NCT00028002|B1|Baseline|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
576131|NCT00028002|P1|Participant Flow|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
576132|NCT00028002|O1|Outcome|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
576167|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
577700|NCT00003631|E1|Reported Event|Group A - Favorable Prognostic Group|
576133|NCT00028002|E1|Reported Event|Imatinib Mesylate|Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
576134|NCT00027560|B1|Baseline|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
576135|NCT00027560|P1|Participant Flow|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
576136|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
576137|NCT00027560|O1|Outcome|Matched Related Patients|
576138|NCT00027560|O1|Outcome|Unrelated and Mismatched Related Patients|
576139|NCT00027560|O1|Outcome|Matched Related Patients|
576140|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
576141|NCT00027560|O1|Outcome|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
576142|NCT00027560|E1|Reported Event|TREATMENT OF LYMPHOHEMATOPOIETIC MALIGNANCIES|This is a stratified single-armed phase II study designed to investigate the safety and efficacy of hematopoietic cell allografts administered after nonmyeloablative cytoreduction.
576143|NCT00027378|B3|Baseline|Total|Total of all reporting groups
576144|NCT00027378|B2|Baseline|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576145|NCT00027378|B1|Baseline|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576146|NCT00027378|P2|Participant Flow|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576147|NCT00027378|P1|Participant Flow|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576148|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576149|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576150|NCT00027378|O2|Outcome|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576151|NCT00027378|O1|Outcome|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576152|NCT00027378|E2|Reported Event|Placebo Plus Treatment as Usual (TAU)|Subjects were treated with placbo plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576153|NCT00027378|E1|Reported Event|Fluoxetine Plus Treatment As Usual (TAU)|Subjects were treated with the medication fluoxetine (15 mg to 30 mg) plus Treatment as Usual (TAU), which included Cognitive Behavioral Therapy and Motivational Enhancement Therapy (CBT/MET) psychotherapy.
576154|NCT00027027|B6|Baseline|Total|Total of all reporting groups
576155|NCT00027027|B5|Baseline|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576156|NCT00027027|B4|Baseline|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576157|NCT00027027|B3|Baseline|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576158|NCT00027027|B2|Baseline|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576159|NCT00027027|B1|Baseline|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576160|NCT00027027|P5|Participant Flow|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576161|NCT00027027|P4|Participant Flow|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576162|NCT00027027|P3|Participant Flow|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576163|NCT00027027|P2|Participant Flow|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576164|NCT00027027|P1|Participant Flow|rhuMAb 2C4: 0.5 Milligrams Per Kilogram (mg/kg)|Recombinant Humanized Antibody to human epidermal growth factor receptor 2 (rhuMAb 2C4) 0.5 mg/kg was administered once every 3 weeks as an intravenous (IV) infusion until progressive disease (PD) or unacceptable toxicity occurred for up to a maximum of 1 year.
576242|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576168|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576169|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576170|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576171|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576172|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576173|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576174|NCT00027027|O4|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576175|NCT00027027|O3|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576176|NCT00027027|O2|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576177|NCT00027027|O1|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576178|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576179|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576180|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576181|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576182|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576183|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576184|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576185|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576186|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576187|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576188|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576189|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576190|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576191|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576192|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576193|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576194|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576195|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576196|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576197|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576198|NCT00027027|O5|Outcome|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576199|NCT00027027|O4|Outcome|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576200|NCT00027027|O3|Outcome|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576201|NCT00027027|O2|Outcome|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576202|NCT00027027|O1|Outcome|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576783|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
576203|NCT00027027|E5|Reported Event|rhuMAb 2C4: 15 mg/kg|rhuMAb 2C4 15 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576204|NCT00027027|E4|Reported Event|rhuMAb 2C4: 10 mg/kg|rhuMAb 2C4 10 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576205|NCT00027027|E3|Reported Event|rhuMAb 2C4: 5 mg/kg|rhuMAb 2C4 5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576206|NCT00027027|E2|Reported Event|rhuMAb 2C4: 2 mg/kg|rhuMAb 2C4 2 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576207|NCT00027027|E1|Reported Event|rhuMAb 2C4: 0.5 mg/kg|rhuMAb 2C4 0.5 mg/kg was administered once every 3 weeks as an IV infusion until PD or unacceptable toxicity occurred for up to a maximum of 1 year.
576208|NCT00026494|B5|Baseline|Total|Total of all reporting groups
576209|NCT00026494|B4|Baseline|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576210|NCT00026494|B3|Baseline|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576211|NCT00026494|B2|Baseline|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576212|NCT00026494|B1|Baseline|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576213|NCT00026494|P4|Participant Flow|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576214|NCT00026494|P3|Participant Flow|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576215|NCT00026494|P2|Participant Flow|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576216|NCT00026494|P1|Participant Flow|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576217|NCT00026494|O4|Outcome|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576218|NCT00026494|O3|Outcome|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576219|NCT00026494|O2|Outcome|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576220|NCT00026494|O1|Outcome|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576221|NCT00026494|E4|Reported Event|30mg/m2 - Vinorelbine|Temozolomide and 30mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576222|NCT00026494|E3|Reported Event|25mg/m2 - Vinorelbine|Temozolomide and 25mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576223|NCT00026494|E2|Reported Event|20mg/m2 - Vinorelbine|Temozolomide and 20mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576224|NCT00026494|E1|Reported Event|15mg/m2 - Vinorelbine|Temozolomide and 15mg/m2 Vinorelbine for Patients with Recurrent Brain Metastases
576225|NCT00026221|B4|Baseline|Total|Total of all reporting groups
576226|NCT00026221|B3|Baseline|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576227|NCT00026221|B2|Baseline|Arm II (Monoclonal Antibody)|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576228|NCT00026221|B1|Baseline|Arm I (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576229|NCT00026221|P3|Participant Flow|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576230|NCT00026221|P2|Participant Flow|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576231|NCT00026221|P1|Participant Flow|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576232|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576233|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576234|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576235|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576236|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576237|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576238|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576239|NCT00026221|O2|Outcome|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576240|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576241|NCT00026221|O3|Outcome|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576243|NCT00026221|O1|Outcome|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576244|NCT00026221|E3|Reported Event|Arm III (Monoclonal Antibody and Biological Therapy)|"Patients receive bevacizumab as in arm I. Patients also receive high-dose IFN-alpha SC on days 1, 3, 5, 8, 10, and 12.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576245|NCT00026221|E2|Reported Event|Arm II: Bevacizumab Alone|"Patients receive bevacizumab as in arm I.~Bevacizumab: Given IV"
576246|NCT00026221|E1|Reported Event|Arm I: Bevacizumab + Iinterferon-alpha-2b|"Patients receive bevacizumab IV over 30-90 minutes on day 1. Patients also receive low-dose interferon alfa (IFN-alpha) SC on days 1-14.~Recombinant Interferon Alfa: Given SC~Bevacizumab: Given IV"
576247|NCT00025883|B3|Baseline|Total|Total of all reporting groups
576248|NCT00025883|B2|Baseline|Metreleptin With Patial Lipodystrophy|patients with partial lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576249|NCT00025883|B1|Baseline|Metreleptin With Generalized Lipodystrophy|patients with generalized lipodystrophy with subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576250|NCT00025883|P1|Participant Flow|Metreleptin|subcutaneous metreleptin injections in one to two daily doses ranging from 0.06 to 0.24 mg/kg/day.
576251|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576252|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576253|NCT00025883|O2|Outcome|Partial Lipodystrophy (PLD)|patients with partial lipodystrophy (PLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576254|NCT00025883|O1|Outcome|Generalized Lipodystrophy (GLD)|patients with generalized lipodystrophy (GLD) with initiation of subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576255|NCT00025883|E1|Reported Event|Metreleptin|subcutaneous metreleptin injection (0.06-0.24 mg/kg/day)
576256|NCT00025662|B1|Baseline|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576257|NCT00025662|P1|Participant Flow|"RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants"|"Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults"
576258|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576259|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576260|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576261|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576262|NCT00025662|O1|Outcome|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576263|NCT00025662|E1|Reported Event|RFT5-SMPT-dgA, an Anti-interleukin, Used in Transplants|Ex vivo selective depletion of alloreactive donor T lymphocytes utilizing RFT5-SMPT-dgA, a specific anti-interleukin-2 receptor immunotoxin in HLA-matched, nonmyeloablative, peripheral blood stem cell transplantation for hematologic malignancies in older adults
576264|NCT00025506|B1|Baseline|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576265|NCT00025506|P1|Participant Flow|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576266|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576267|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576268|NCT00025506|O1|Outcome|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576269|NCT00025506|E1|Reported Event|Thalidomide|Thalidomide 200 mg PO once a day initial dose (each 28-day period will be considered one cycle). Dose increased by 200 mg every 2 weeks to maximum dose of 1000 mg/day until disease progression or adverse effects prohibit further therapy.
576270|NCT00025233|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576271|NCT00025233|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576784|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
576272|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576273|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576274|NCT00025233|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576275|NCT00025233|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576276|NCT00025155|B1|Baseline|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576277|NCT00025155|P1|Participant Flow|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576278|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576279|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576280|NCT00025155|O1|Outcome|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576281|NCT00025155|E1|Reported Event|Treatment (Ixabepilone)|Patients receive ixabepilone IV over 1 hour on days of 1, 8 and 15 of a 28-day cycle. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive 2 additional courses after achieving CR.
576282|NCT00024258|B1|Baseline|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
576283|NCT00024258|P1|Participant Flow|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
576284|NCT00024258|O1|Outcome|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
576285|NCT00024258|E1|Reported Event|Arsenic Trioxide|"Patients receive arsenic trioxide IV over 1-4 hours on days 1-5 and 8-12. Treatment repeats every 28 days for a maximum of 6 courses in the absence of disease progression or unacceptable toxicity.~Patients are followed every 2-3 months for 1 year and then annually thereafter."
576286|NCT00024167|B4|Baseline|Total|Total of all reporting groups
576287|NCT00024167|B3|Baseline|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
576288|NCT00024167|B2|Baseline|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
576289|NCT00024167|B1|Baseline|Induction Treatment|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel.
576290|NCT00024167|P2|Participant Flow|Induction Treatment + No Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
576291|NCT00024167|P1|Participant Flow|Induction Treatment + Strontium-89|Induction treatment option 1: Weeks 1,3,5: Doxorubicin 20 mg/m^2 IV, day 1 and Ketoconazole 400 mg oral 3 x daily, days 1 through 7. Weeks 2,4,6: Vinblastine 4 mg/m^2 IVPB, day 1 and Estramustine 140 mg oral 3 x daily, days 1 through 7. Weeks 7,8: No treatment. Hydrocortisone 10 mg oral 2 x daily will be administered throughout treatment or Induction treatment option 2: Prednisone 5 mg oral 2 x daily, weeks 1-14 and Docetaxel 75 mg/m^2 IVPB over 1 hour, every 3 weeks. Dexamethasone 4 mg is given orally at 12 and 1 hours before and 12 hours after docetaxel. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
576292|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
576293|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
576294|NCT00024167|O2|Outcome|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
576295|NCT00024167|O1|Outcome|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
576296|NCT00024167|E3|Reported Event|Induction Treatment + No Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin 20mg/m^2 IV over 24 hours once weekly for 6 weeks.
576297|NCT00024167|E2|Reported Event|Induction Treatment + Strontium-89|Induction treatment option 1 or induction treatment option 2. Randomization: Doxorubicin IV over 24 hours once weekly for 6 weeks + Strontium-89 IV once at beginning of chemotherapy.
576298|NCT00024167|E1|Reported Event|Induction Treatment|Induction treatment option 1 or induction treatment option 2.
576299|NCT00024102|B3|Baseline|Total|Total of all reporting groups
576300|NCT00024102|B2|Baseline|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
576301|NCT00024102|B1|Baseline|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
576302|NCT00024102|P2|Participant Flow|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
576303|NCT00024102|P1|Participant Flow|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles~OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
576304|NCT00024102|O3|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
576305|NCT00024102|O2|Outcome|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
576306|NCT00024102|O1|Outcome|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
576307|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
576308|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
576309|NCT00024102|O2|Outcome|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles.
576310|NCT00024102|O1|Outcome|Standard Chemotherapy|"Patient/Physician choice of:~CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles OR~AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles"
576311|NCT00024102|E3|Reported Event|Capecitabine|Capecitabine (2000 mg/m^2 in 2 doses days 1-14) repeated every 21 days for 6 cycles
576312|NCT00024102|E2|Reported Event|Standard Chemotherapy (AC)|AC: Cyclophosphamide (600 mg/m^2 by IV on day 1)+ doxorubicin (60 mg/m^2 by IV on day 1) repeated every 21 days for 4 cycles
576313|NCT00024102|E1|Reported Event|Standard Chemotherapy (CMF)|CMF: cyclophosphamide (100 mg/m^2 orally days 1-14)+ MTX (40 mg/m^2 by IV days 1 and 8) + 5-FU (600 mg/m^2 by IV days 1 and 8) repeated every 28 days for 6 cycles
576314|NCT00023764|B1|Baseline|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
576315|NCT00023764|P1|Participant Flow|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
576316|NCT00023764|O2|Outcome|PS-341 (Bortezomib)-Refractory Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
576317|NCT00023764|O1|Outcome|PS-341 (Bortezomib)-Relapsed Patients|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
576318|NCT00023764|E1|Reported Event|PS-341 (Bortezomib)|Patients receive an infusion of bortezomib over 3-5 seconds two times a week for two weeks or once weekly for 4 weeks. Treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. Patients who achieve at least a partial response lasting at least 6 months may receive retreatment.
576319|NCT00023712|B3|Baseline|Total|Total of all reporting groups
576320|NCT00023712|B2|Baseline|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576613|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
576321|NCT00023712|B1|Baseline|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576322|NCT00023712|P2|Participant Flow|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576323|NCT00023712|P1|Participant Flow|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576324|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576325|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576326|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576327|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576328|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576329|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576330|NCT00023712|O2|Outcome|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576331|NCT00023712|O1|Outcome|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576332|NCT00023712|E2|Reported Event|Cohort 2|Patients enrolled 4/5/2004 through 9/6/2005 receive bortezomib 1.3 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576333|NCT00023712|E1|Reported Event|Cohort 1|Patients enrolled 11/5/2001 through 1/6/2003 receive bortezomib 1.5 mg/m2/dose IV twice weekly for 2 weeks (Days 1,4,8, and 11) followed by a 10day rest period (Days 12-21). At least 72 hours should elapse between consecutive doses.Courses repeat every 3 weeks (21 days) until disease progression or adverse effects prohibit further therapy.
576334|NCT00023673|B4|Baseline|Total|Total of all reporting groups
576335|NCT00023673|B3|Baseline|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576336|NCT00023673|B2|Baseline|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576337|NCT00023673|B1|Baseline|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576338|NCT00023673|P4|Participant Flow|Phase II: 74 Gy/37 fx + Chemotherapy|Phase II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576339|NCT00023673|P3|Participant Flow|Phase I: 70 Gy/35 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 70 Gy given in 35 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576470|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576340|NCT00023673|P2|Participant Flow|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576341|NCT00023673|P1|Participant Flow|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576342|NCT00023673|O1|Outcome|Phase I/II: 74 Gy/37 fx + Chemotherapy|"Phase I/II: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.~carboplatin~paclitaxel~three-dimensional conformal radiation therapy"
576343|NCT00023673|O2|Outcome|Phase I: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576344|NCT00023673|O1|Outcome|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576345|NCT00023673|E2|Reported Event|Phase I/II: 74 Gy/37 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 74 Gy given in 37 fractions (2.0 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576346|NCT00023673|E1|Reported Event|Phase I: 75.25 Gy/36 fx + Chemotherapy|Phase I: Three-dimensional conformal radiation therapy (3DRT) of 75.25 Gy given in 36 fractions (2.15 Gy per fraction) with concurrent chemotherapy consisting of weekly paclitaxel at 50mg/m2 and carboplatin at area under the curve 2mg/m2. Adjuvant systemic chemotherapy (two cycles of paclitaxel and carboplatin) following completion of RT was optional.
576347|NCT00023452|B3|Baseline|Total|Total of all reporting groups
576348|NCT00023452|B2|Baseline|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576349|NCT00023452|B1|Baseline|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576350|NCT00023452|P2|Participant Flow|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral rifapentine (RPT) tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by Directly Observed Therapy (DOT), defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576351|NCT00023452|P1|Participant Flow|9INH|Participants who were high-risk tuberculin skin test (TST) reactors (household and other close contacts of active tuberculosis [TB] cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on chest x-ray [CXR], human immunodeficiency virus [HIV] infected participants) self-administered oral isoniazid (INH) tablets (aged greater than or equal to [≥12] years of age received 5 milligrams per kilogram [mg/kg] and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576352|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576353|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576354|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576355|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576614|NCT00016913|E1|Reported Event|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer.
576356|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576357|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576358|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576359|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576360|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576361|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576362|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576363|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576364|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576365|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576366|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV-infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576367|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR], HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576368|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576369|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576370|NCT00023452|O2|Outcome|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576371|NCT00023452|O1|Outcome|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (aged ≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) daily for 9 months (240 to 270 total doses).
576372|NCT00023452|E2|Reported Event|3RPT/INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) received oral INH tablets (≥12 years of age received 15 mg/kg and participants 2-11 years of age received 25 mg/kg) and oral RPT tablets (between 300-900 mg based on weight) once per week for 3 months (11 to 12 total doses) administered by DOT, defined as a healthcare worker observing ingestion of each dose of RPT and INH.
576373|NCT00023452|E1|Reported Event|9INH|Participants who were high-risk TST reactors (household and other close contacts of active TB cases, recent [within 2 years] tuberculin converters, participants with fibrotic lesions on CXR, HIV infected participants) self-administered oral INH tablets (≥12 years of age received 5 mg/kg and participants 2-11 years of age received 10-15 mg/kg) once daily for 9 months (240 to 270 total doses).
576374|NCT00023322|B1|Baseline|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
576375|NCT00023322|P1|Participant Flow|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
576376|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
576377|NCT00023322|O1|Outcome|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
576378|NCT00023322|E1|Reported Event|Peginterferon Alpha-2a|Patients with hepatitis D virus (HDV) infection are treated with pegylated alpha interferon therapy for 3 years. The dose of the drug is 180 mcg/week.
576379|NCT00023309|B3|Baseline|Total|Total of all reporting groups
576380|NCT00023309|B2|Baseline|Adefovir|Patients to receive adefovir alone
576381|NCT00023309|B1|Baseline|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576382|NCT00023309|P2|Participant Flow|Adefovir|Patients to receive adefovir alone (10 mg daily).
576383|NCT00023309|P1|Participant Flow|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir, with lamivudine of 100 mg daily and adefovir of 10 mg daily
576384|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
576385|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576386|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
576387|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576388|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
576389|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576390|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
576391|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576392|NCT00023309|O2|Outcome|Adefovir|Patients to receive adefovir alone
576393|NCT00023309|O1|Outcome|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576394|NCT00023309|E2|Reported Event|Adefovir|Patients to receive adefovir alone
576395|NCT00023309|E1|Reported Event|Lamivudine and Adefovir|Patients to receive combination lamivudine and adefovir
576396|NCT00022763|B3|Baseline|Total|Total of all reporting groups
576397|NCT00022763|B2|Baseline|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576398|NCT00022763|B1|Baseline|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576399|NCT00022763|P2|Participant Flow|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576400|NCT00022763|P1|Participant Flow|Stratum A|Participants of age greater than or equal to (>=) 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576401|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576785|NCT00010257|O2|Outcome|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
576402|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576403|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576404|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576405|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576406|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576407|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576408|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576409|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576410|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576411|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576412|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576413|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576414|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576786|NCT00010257|O1|Outcome|Thymoma|Patients with diagnosis of thymoma
576415|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576416|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576417|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576418|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576419|NCT00022763|O2|Outcome|Stratum B|Participants of age >= 12 years and less than 17 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576420|NCT00022763|O1|Outcome|Stratum A|Participants of age >= 3 years and less than 12 years received enfuvirtide subcutaneously twice daily (BID) at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose for 48 weeks. At the end of the 48 weeks of treatment, participants were allowed to continue into the extension phase and take enfuvirtide up to a maximum of an additional 48 weeks (a total of 96 weeks from study entry), or until 12 weeks after the commercial availability of enfuvirtide in the country of the participant’s participation, whichever came first.
576421|NCT00022763|E1|Reported Event|Enfuvirtide|Participants in stratum A (age >= 3 years and less than 12 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose) and in stratum B (age >= 12 years and less than 17 years received Enfuvirtide Subcutaneously BID at 2.0 mg/kg per dose, up to the adult maximum of 90 mg per dose).
576422|NCT00022698|B3|Baseline|Total|Total of all reporting groups
576423|NCT00022698|B2|Baseline|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576424|NCT00022698|B1|Baseline|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576425|NCT00022698|P2|Participant Flow|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576426|NCT00022698|P1|Participant Flow|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine (Xeloda) 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute intravenous (IV) infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576427|NCT00022698|O3|Outcome|Total Participants (Cohort 1 + Cohort 2)|Total of all reporting groups.
576471|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576787|NCT00010257|E2|Reported Event|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
576428|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576429|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576430|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576431|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576432|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576433|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576434|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576435|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576436|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576437|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576438|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576439|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576440|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576441|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576442|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576443|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576444|NCT00022698|O2|Outcome|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576445|NCT00022698|O1|Outcome|Cohort 1, Initial Regimen:(Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576446|NCT00022698|E2|Reported Event|Cohort 2, Amended Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 900 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 100 mg/m^2 as a 90-minute IV infusion on Day 1 and 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576472|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576473|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576788|NCT00010257|E1|Reported Event|Thymoma|Patients with diagnosis of thymoma
576447|NCT00022698|E1|Reported Event|Cohort 1, Initial Regimen: (Capecitabine + Irinotecan)|Participants received capecitabine 1000 mg/m^2, orally, twice daily, for 14 days (Day 2 through Day 15) every 3 weeks, along with irinotecan 125 mg/m^2 as a 90-minute IV infusion on Day 1 and Day 8, every 3 weeks. A total of 12 cycles of treatment was administered. At the discretion of the investigator, participants who were responding or whose disease was stable were permitted to continue capecitabine/irinotecan combination therapy until progressive disease was documented in the post-study treatment phase. Participants not receiving post-study treatment were followed every 3 months until time of death, loss to follow-up, or until median survival had been reached (whichever occurred first).
576448|NCT00022672|B3|Baseline|Total|Total of all reporting groups
576449|NCT00022672|B2|Baseline|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576450|NCT00022672|B1|Baseline|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576451|NCT00022672|P2|Participant Flow|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576452|NCT00022672|P1|Participant Flow|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576453|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576454|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576455|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576456|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576457|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576458|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576459|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576460|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576461|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576462|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576463|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576464|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576465|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576466|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576467|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576468|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576469|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576789|NCT00009737|B3|Baseline|Total|Total of all reporting groups
577653|NCT00003869|E1|Reported Event|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
576474|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576475|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576476|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576477|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576478|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576479|NCT00022672|O2|Outcome|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576480|NCT00022672|O1|Outcome|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576481|NCT00022672|E3|Reported Event|Anastrozole (After Start of Trastuzumab)|1 mg oral dose of anastrozole every day for 24 Months in the Main phase. In the Extension Phase participants could cross-over to also receive trastuzumab 4 mg/kg initial loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes.
576482|NCT00022672|E2|Reported Event|Anastrozole|1 mg oral dose of anastrozole every day for 24 Months in the Main phase.
576483|NCT00022672|E1|Reported Event|Trastuzumab + Anastrozole|Trastuzumab 4 mg/kg loading dose intravenous (iv) over 90 minutes, followed by weekly doses of 2 mg/kg iv over 30 minutes plus 1 mg oral dose of anastrozole every day for 24 Months in the Main phase and in the Extension Phase.
576484|NCT00022659|B1|Baseline|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576485|NCT00022659|P1|Participant Flow|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576486|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576487|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576488|NCT00022659|O1|Outcome|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576489|NCT00022659|E1|Reported Event|Bevacizumab|Bevacizumab 15 mg/kg IV, every 3 weeks (one cycle) until disease progression or adverse effects prohibit further therapy
576490|NCT00022633|B3|Baseline|Total|Total of all reporting groups
576491|NCT00022633|B2|Baseline|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576492|NCT00022633|B1|Baseline|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576493|NCT00022633|P2|Participant Flow|Paclitaxel + Gemcitabine (Younger Cohort: Age < 60)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576494|NCT00022633|P1|Participant Flow|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576495|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576496|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576497|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576498|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576499|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576500|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576501|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576502|NCT00022633|O1|Outcome|Paclitaxel + Gemcitabine (Elderly Cohort: Age >= 70)|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576503|NCT00022633|E1|Reported Event|Paclitaxel + Gemcitabine|Patients received 1000 mg /m^2 of gemcitabine on Day 1 and 8 and 175 mg/m^2 of paclitaxel on Day 1 intravenously every 21 days for 6 cycles ( 1 cycle = 21 days)
576504|NCT00022516|B3|Baseline|Total|Total of all reporting groups
577654|NCT00003782|B4|Baseline|Total|Total of all reporting groups
576505|NCT00022516|B2|Baseline|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576506|NCT00022516|B1|Baseline|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576507|NCT00022516|P2|Participant Flow|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576508|NCT00022516|P1|Participant Flow|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576509|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576510|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576511|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576512|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576513|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576514|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576515|NCT00022516|O2|Outcome|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576516|NCT00022516|O1|Outcome|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576517|NCT00022516|E2|Reported Event|CM-Maintenance|"12-month CM-maintenance regimen (C, cyclophosphamide 50 mg/day orally continuously and M, methotrexate 2.5 mg twice/day orally days 1 and 2 of every week for 1 year)~Cyclophosphamide: 50 mg/day orally continuously for 1 year~Methotrexate: 2.5 mg twice/day orally days 1 and 2 of every week for 1 year"
576518|NCT00022516|E1|Reported Event|No-CM|No further chemotherapy following standard adjuvant chemotherapy.
576519|NCT00022490|B1|Baseline|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
576520|NCT00022490|P1|Participant Flow|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
576521|NCT00022490|O1|Outcome|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
576522|NCT00022490|E1|Reported Event|Cytarabine/ Imatinib Mesylate|"Cytarabine: Once daily subcutaneous injection of Ara-C (Cytarabine) at a dose of 20 mg (10 mg or 5 mg if they have been dose reduced) per square meter of calculated body surface area, on days 15-28 of each sequential 28 day cycle~Imatinib Mesylate: Once daily oral administration of STI571 (Imatinib Mesylate) at a dose of 400 mg for 12 months"
576523|NCT00021541|B3|Baseline|Total|Total of all reporting groups
576524|NCT00021541|B2|Baseline|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I. These are the patients that started on placebo only. This number does not reflect the total amount of patients that crossed over to tipifarnib. Two of the 31 patients were deemed ineligible, thus 29 started placebo.
576525|NCT00021541|B1|Baseline|R115777 (Tipifarnib)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. These are the patients that started on tipifarnib only. This number does not reflect the total amount of patients that crossed over to placebo.
576526|NCT00021541|P2|Participant Flow|Placebo|Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I.Patients receive placebo ONLY in the first treatment until they progress to the second treatment/crossover to receive tipifarnib.
576527|NCT00021541|P1|Participant Flow|Tipifarnib (R11577)|Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.Patients receive tipifarnib ONLY in the first treatment until they progress to the second treatment/crossover to receive placebo.
576528|NCT00021541|O1|Outcome|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
576529|NCT00021541|O2|Outcome|Phase B|Placebo/Tipifarnib
576530|NCT00021541|O1|Outcome|Phase A|Tipifarnib/placebo
576531|NCT00021541|E1|Reported Event|Tipifarnib & Placebo|"Patients receive oral tipifarnib every 12 hours on days 1-21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.~Patients receive oral placebo every 12 hours on days 1-21. Courses repeat as in arm I."
576532|NCT00021255|B4|Baseline|Total|Total of all reporting groups
576547|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576533|NCT00021255|B3|Baseline|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576534|NCT00021255|B2|Baseline|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576535|NCT00021255|B1|Baseline|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576536|NCT00021255|P3|Participant Flow|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576537|NCT00021255|P2|Participant Flow|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576538|NCT00021255|P1|Participant Flow|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² intravenous (IV) bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576539|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576540|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576541|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576542|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576543|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576544|NCT00021255|O1|Outcome|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576545|NCT00021255|O3|Outcome|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576546|NCT00021255|O2|Outcome|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576548|NCT00021255|E3|Reported Event|Docetaxel + Carboplatin + Herceptin (TCH)|Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 1 only, followed by Herceptin 2 mg/kg IV infusion weekly starting from Day 8 until three weeks after the last cycle of chemotherapy. Docetaxel 75 mg/ m² IV infusion on Day 2 of Cycle 1, then on Day 1 of all subsequent cycles followed by carboplatin IV infusion at target AUC = 6 mg/mL/min repeated every 3 weeks for a total of 6 cycles. After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg by IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576549|NCT00021255|E2|Reported Event|AC Followed by Docetaxel + Herceptin (AC→TH)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus Injection on Day 1 of every 3 weeks for 4 cycles. Herceptin 4 mg/kg IV infusion on Day 1 of Cycle 5, followed by Herceptin 2 mg/kg by IV infusion weekly starting from Day 8; and docetaxel 100 mg/m² IV infusion on Day 2 of Cycle 5, then on Day 1 of every 3 weeks for all subsequent cycles ( total 4 cycles). After completion of the last cycle of chemotherapy, Herceptin 6 mg/kg IV infusion was administered every 3 weeks until 1 year from date of initial Herceptin dose.
576550|NCT00021255|E1|Reported Event|Doxorubicin+Cyclophosphamide (AC) Followed by Docetaxel (AC→T)|Doxorubicin 60 mg/m² IV bolus injection in combination with cyclophosphamide 600 mg/m² IV bolus injection on Day 1 of every 3 weeks for 4 cycles followed by docetaxel 100 mg/m² IV infusion every 3 weeks for another 4 cycles.
576551|NCT00021229|B4|Baseline|Total|Total of all reporting groups
576552|NCT00021229|B3|Baseline|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576553|NCT00021229|B2|Baseline|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576554|NCT00021229|B1|Baseline|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576555|NCT00021229|P3|Participant Flow|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576556|NCT00021229|P2|Participant Flow|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576557|NCT00021229|P1|Participant Flow|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576558|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576606|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576559|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576560|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576561|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576562|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576563|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576564|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576565|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576566|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576567|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576607|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576568|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576569|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576570|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576571|NCT00021229|O3|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576572|NCT00021229|O2|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576573|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576574|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576575|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576608|NCT00019604|E1|Reported Event|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
577262|NCT00006151|P1|Participant Flow|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
576576|NCT00021229|O2|Outcome|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576577|NCT00021229|O1|Outcome|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576578|NCT00021229|O1|Outcome|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576579|NCT00021229|E3|Reported Event|Stratum IIB: Imatinib Mesylate|"Children with recurrent high-grade gliomas on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Eight participants were enrolled on the phase I before the amendment and eight after the amendment."
576580|NCT00021229|E2|Reported Event|Stratum IIA: Imatinib Mesylate|"Children with recurrent high-grade gliomas not on enzyme-inducing anticonvulsant drugs (EIACDs) received imatinib twice daily at a starting dose of 350 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 4 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity. Study participants did not receive radiation therapy in this stratum.~Because of concerns of intratumoral hemorrhage, the protocol was amended (08JAN2003) to extend the MTD estimation period to 8 weeks (courses 1 and 2).~Ten participants were enrolled on the phase I before the amendment and 23 after the amendment."
576581|NCT00021229|E1|Reported Event|Stratum I: Radiation + Imatinib Mesylate|"Children with newly diagnosed brainstem gliomas received imatinib twice daily at a starting dose of 200 mg/m2/day. Treatment cycles were 4 weeks (maximum tolerated dose (MTD) estimation period - first 8 weeks) and imatinib was continued for up to 52 weeks in the absence of progression or serious toxicity.~Local irradiation (RT) was administered concurrently with imatinib at the initiation of treatment with conventional fractionation at 180 cGy/day fractions, five days per week for six weeks, to a total dose of 5580 cGy.~Because of concerns of intratumoral hemorrhage during RT, the protocol was amended (08JAN2003) to enroll patients without evidence of hemorrhage prior to RT and begin imatinib treatment 2 weeks (± 1 week) after completion of RT.~Participants enrolled to the phase II part received imatinib at the MTD (from phase I) after RT.~Six participants were enrolled on the phase I before the amendment, 29 after the amendment, and 1 on the phase II."
576582|NCT00020722|B1|Baseline|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 mins. prior to and then 3, 6, and 9 hrs after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
576583|NCT00020722|P1|Participant Flow|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
576609|NCT00016913|B1|Baseline|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
576610|NCT00016913|P1|Participant Flow|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
576611|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
576612|NCT00016913|O1|Outcome|Neo-Adj ChemoTx + Ablation Prior to RT|Treatment with chemotherapy plus androgen ablation prior to radiation treatment for poor prognosis localized prostate cancer
576584|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis, the lymphocytes will be activated with soluble monoclonal anti-CD3 antibody (OKT3) which cross-links the CD3 receptors on T cells and activates T cells.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 mg/m2.~Carboplatin at a dose of"
576585|NCT00020722|O1|Outcome|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.~The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
576586|NCT00020722|E1|Reported Event|Therapeutic Autologous Lymphocytes|"therapeutic autologous lymphocytes: Immediately after pheresis.,The time for ATC infusions will vary from patient to patient, but the infusion rate will be approximately 10 × 109 ATC will be based on the rate calculated from the endotoxin level in the cell product. All patients will be observed for at least 1 hr after an infusion.~Ifosfamide, carboplatin, and etoposide (ICE) regimen: Ifosfamide 2,500 mg/m2 given IV daily on day -8, -7, -6, -5, -4, and -3 prior to PBSCT. Ifosfamide 2,500 mg/m2 infused IV over 1 hour (hour 0-1) on days -8 to -3 for a total dose of 15,000 mg/m2.~Mesna will be administered per BMT Standard of Care Guideline at a dose of 25% of the total Ifosfamide dose 30 minutes prior to and then 3, 6, and 9 hours after ifosfamide daily on days -8, -7, -6, -5, -4, and -3 prior to PBSCT for a total dose of 2500 m"
576587|NCT00019747|B3|Baseline|Total|Total of all reporting groups
576588|NCT00019747|B2|Baseline|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
576589|NCT00019747|B1|Baseline|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
576590|NCT00019747|P2|Participant Flow|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
576591|NCT00019747|P1|Participant Flow|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
576592|NCT00019747|O2|Outcome|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
576593|NCT00019747|O1|Outcome|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
576594|NCT00019747|E2|Reported Event|Arm 2 - Placebo Once Daily|Patients receive oral placebo once daily.
576595|NCT00019747|E1|Reported Event|Arm 1 - Thalidomide Once Daily|Patients receive oral thalidomide 100 mg at bedtime once daily for 4 weeks, then progresses to 200 mg at bedtime for 4 weeks, then progresses to 300 mg at bedtime (maintenance dose).
576596|NCT00019604|B1|Baseline|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576597|NCT00019604|P1|Participant Flow|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576598|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576599|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576600|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576601|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576602|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576603|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576604|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
576605|NCT00019604|O1|Outcome|Radiofrequency Ablation in Liver Cancer|This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
577263|NCT00006151|O2|Outcome|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
576615|NCT00018031|B1|Baseline|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
576616|NCT00018031|P1|Participant Flow|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
576617|NCT00018031|O1|Outcome|Peginterferon Alfa-2b, Ribavirin|"Weekly Injection (Peginterferon alfa-2b)~Peginterferon Alfa-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills (Ribavirin)~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
576618|NCT00018031|E1|Reported Event|Peg-interefron Alfa 2b, Ribavirin|"Weekly Injection~Peginterferon alpha-2b : Weekly injections for 48 weeks of a dose of 1.5mcg/Kg per week subcutaneously~Oral Pills~Ribavirin : Weight based Ribavirin dosing 1-1.2grams/day in divided (twice daily) doses for a total duration of 48 weeks."
576619|NCT00017563|B1|Baseline|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
576620|NCT00017563|P1|Participant Flow|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
576621|NCT00017563|O1|Outcome|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
576622|NCT00017563|E1|Reported Event|Docetaxel and Mitox|"Drug: docetaxel~35 mg/m2 i.v. over 15 - 30 minutes will be administered immediately after the mitoxantrone on the same schedule.~Drug: mitoxantrone hydrochloride~Initial dose will be 2 mg/m2 weekly for 3 of every 4 weeks. The dose will then be escalated as described in the dose escalation section up to a maximum dose of 6 mg/m2 weekly for 3 of every 4 weeks."
576623|NCT00016354|B1|Baseline|Benzoylphenylurea|BPU, administered over a dose range of 5–320 mg
576624|NCT00016354|P8|Participant Flow|Benzoylphenylurea Dose Level of 150 mg|Benzoylphenylurea dose level of 150 mg; Dose level 8 (for this dose level, a 25 mg capsule was used. At all previous dose levels, a 5 mg capsule was administered.)
576625|NCT00016354|P7|Participant Flow|Benzoylphenylurea 320 mg|Benzoylphenylurea dose level of 320 mg; Dose level 7
576626|NCT00016354|P6|Participant Flow|Benzoylphenylurea 160 mg|Benzoylphenylurea dose level of 160 mg; Dose level 6
576627|NCT00016354|P5|Participant Flow|Benzoylphenylurea 80 mg|Benzoylphenylurea dose level of 80 mg; Dose level 5
576628|NCT00016354|P4|Participant Flow|Benzoylphenylurea 40 mg|Benzoylphenylurea dose level of 40 mg; Dose level 4
576629|NCT00016354|P3|Participant Flow|Benzoylphenylurea 20 mg|Benzoylphenylurea dose level of 20 mg; Dose level 3
576630|NCT00016354|P2|Participant Flow|Benzoylphenylurea 10 mg|Benzoylphenylurea dose level of 10 mg; Dose level 2
576631|NCT00016354|P1|Participant Flow|Benzoylphenylurea 5 mg|Benzoylphenylurea dose level of 5 mg; Dose level 1
576632|NCT00016354|O1|Outcome|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
576633|NCT00016354|E1|Reported Event|Benzoylphenylurea|BPU, administered over a dose range of 5-320 mg
576634|NCT00015847|B1|Baseline|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576635|NCT00015847|P1|Participant Flow|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576636|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576637|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576638|NCT00015847|O1|Outcome|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576639|NCT00015847|E1|Reported Event|Imatinib Mesylate|Once daily oral administration of STI571 (imatinib mesylate) at a dose of 400 mg or 600mg for 12 months.
576640|NCT00014495|B5|Baseline|Total|Total of all reporting groups
576641|NCT00014495|B4|Baseline|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576642|NCT00014495|B3|Baseline|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576733|NCT00012012|P2|Participant Flow|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
576643|NCT00014495|B2|Baseline|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576644|NCT00014495|B1|Baseline|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576645|NCT00014495|P4|Participant Flow|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576646|NCT00014495|P3|Participant Flow|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576647|NCT00014495|P2|Participant Flow|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576648|NCT00014495|P1|Participant Flow|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576649|NCT00014495|O1|Outcome|Bismuth Bi 213 Monoclonal Antibody M195 & Cytarabine|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD.~Patients are followed twice weekly for 4 weeks and then monthly for 3 months~filgrastim~cytarabine~bismuth Bi213 monoclonal antibody M195"
576650|NCT00014495|E4|Reported Event|Bismuth-labeled HuM195 (1.25 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576651|NCT00014495|E3|Reported Event|Bismuth-labeled HuM195 (1 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576679|NCT00013611|P2|Participant Flow|Antiretroviral Therapy Only|All patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used.
577161|NCT00006289|O3|Outcome|VAS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
576652|NCT00014495|E2|Reported Event|Bismuth-labeled HuM195 (0.75 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576653|NCT00014495|E1|Reported Event|Bismuth-labeled HuM195 (0.5 mCi/kg)|"Patients receive cytarabine IV continuously on days 1-5. Beginning between days 7 and 14, patients receive Bi213 MOAB M195 IV over 5 minutes up to 4 times daily over 1-4 days. Patient also receive filgrastim (G-CSF) subcutaneously daily beginning 24 hours after the final Bi213 MOAB M195 infusion and continuing until blood counts recover. Treatment continues in the absence of disease progression or unacceptable toxicity.~Cohorts of 3 to 6 patients receive escalating doses of Bi213 MOAB M195 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose at which 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined, subsequent patients are treated at the MTD."
576654|NCT00015457|B1|Baseline|Cervical Dystonia|All participants enrolled in study
576655|NCT00015457|P2|Participant Flow|Placebo Then Amlodipine|Patients with cervical dystonia receiving botulinum toxin injections plus Placebo during the first period and botulinum toxin injections plus Amlodipine during the second period.
576656|NCT00015457|P1|Participant Flow|Amlodipine Then Placebo|Patients with cervical dystonia receiving botulinum toxin injections plus Amlodipine during the first period and botulinum toxin injections plus Placebo during the second period.
576657|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
576658|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
576659|NCT00015457|O2|Outcome|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
576660|NCT00015457|O1|Outcome|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
576661|NCT00015457|E2|Reported Event|Placebo|Patients receiving Placebo plus botulinum toxin injections during either period.
576662|NCT00015457|E1|Reported Event|Amlodipine|Patients receiving Amlodipine plus botulinum toxin injections during either period.
576663|NCT00014911|B1|Baseline|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576664|NCT00014911|P1|Participant Flow|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576665|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576666|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576728|NCT00012298|E2|Reported Event|Treatment: Trial 1, Dose Level 2|0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
576729|NCT00012298|E1|Reported Event|Treatment: Trial 1, Dose Level 1|0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8
576730|NCT00012012|B3|Baseline|Total|Total of all reporting groups
576777|NCT00010439|E1|Reported Event|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
576667|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576668|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576669|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576670|NCT00014911|O1|Outcome|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576671|NCT00014911|E1|Reported Event|Islet Transplantation|"Participants received portal vein islet infusions (up to 3), e.g., islet transplantations, with a targeted total of exceeding 10,000 islet equivalents per kilogram of body weight (IE/kg) per infusion. 25 participants received 2 transplantations and 16 participants received 3 transplantations. Participants received steroid-free post-transplantation immunosuppressive medications:~Daclizumab 1 mg/kg intravenously immediately pre-transplantation and 2, 4, 6, and 8 weeks post-transplantation.~Sirolimus 0.2 mg/kg by mouth once pre-transplantation then 0.1 mg/kg daily post-transplantation. Dosing was adjusted to achieve a trough peripheral blood level of 12-15 ng/mL x3 months after transplantation and 7-12 ng/mL for the remainder of the study.~Tacrolimus 1 mg by mouth x1 pre-transplantation followed by 1 mg twice daily post transplantation. Levels were adjusted to achieve a peripheral blood trough level of 3-6 ng/mL for maintenance immunosuppression."
576672|NCT00014560|B1|Baseline|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
576673|NCT00014560|P1|Participant Flow|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
576674|NCT00014560|O1|Outcome|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
576675|NCT00014560|E1|Reported Event|Single Arm|This is a Phase 1a/1b trial. three patients will be treated at dose level 1.If no Grade 3 or 4 toxicities, the next dose level will be given to a new cohort of three. If 1 of 3 patients suffer Grade 3 or 4 toxicity, an additional 3 patients will be treated at same dose level.if 1/6 have a Grade 3 or 4 toxicity, proceed to next dose level with a cohort of 3 patients. If > 1/6 experience garde 3 or 4 toxicity, the DLT has been reached and the MTD is the dose level prior. Six patients will be treated at the MTD.
576676|NCT00013611|B3|Baseline|Total|Total of all reporting groups
576677|NCT00013611|B2|Baseline|Antiretroviral Therapy Only|
576678|NCT00013611|B1|Baseline|Proleukin Plus Antiretroviral Therapy|
576778|NCT00010257|B3|Baseline|Total|Total of all reporting groups
576779|NCT00010257|B2|Baseline|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
576680|NCT00013611|P1|Participant Flow|Proleukin Plus Antiretroviral Therapy|Patients receive an initial dose of 4.5 MIU of proleukin twice daily for 5 consecutive days every 8 weeks during the first year (6 cycles total). After the first year, additional cycles are given to either achieve or maintain the patient's CD4+ count goal. CD4+ goal is defined as an increase of 125 cells/cubic mm for participants in the 50-199 CD4+ count stratum, and an increase of 175 cells/cubic mm for participants in the 200-299 CD4+ stratum. In addition, all patients must be prescribed combination antiretroviral drug treatment. The choice of combination therapy is left to the discretion of the treating clinician. Investigators will use their national guidelines for determining when antiretroviral therapy should be changed and for when determining when therapy should be used. All patients must take antiretroviral therapy during each 5-consecutive-day treatment cycle.
576681|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576682|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576683|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576684|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576685|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576686|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576687|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576688|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576689|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576690|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576691|NCT00013611|O2|Outcome|Antiretroviral Therapy Only|
576692|NCT00013611|O1|Outcome|Proleukin Plus Antiretroviral Therapy|
576693|NCT00013611|E2|Reported Event|Antiretroviral Therapy Only|
576694|NCT00013611|E1|Reported Event|Proleukin Plus Antiretroviral Therapy|
576695|NCT00012298|B8|Baseline|Total|Total of all reporting groups
576696|NCT00012298|B7|Baseline|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576697|NCT00012298|B6|Baseline|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576698|NCT00012298|B5|Baseline|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576699|NCT00012298|B4|Baseline|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576700|NCT00012298|B3|Baseline|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576701|NCT00012298|B2|Baseline|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
576702|NCT00012298|B1|Baseline|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
576731|NCT00012012|B2|Baseline|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
576780|NCT00010257|B1|Baseline|Thymoma|Patients with diagnosis of thymoma
576781|NCT00010257|P2|Participant Flow|Thymic Carcinoma|Patients with diagnosis of thymic carcinoma
576703|NCT00012298|P7|Participant Flow|Treatment : Phase II (Dose Level 6)|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576704|NCT00012298|P6|Participant Flow|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576705|NCT00012298|P5|Participant Flow|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576706|NCT00012298|P4|Participant Flow|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576707|NCT00012298|P3|Participant Flow|Treatment: Trial 2, Dose Level 3|"Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576708|NCT00012298|P2|Participant Flow|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
576709|NCT00012298|P1|Participant Flow|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8."
576710|NCT00012298|O1|Outcome|Treatment : Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576711|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576712|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576732|NCT00012012|B1|Baseline|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
576734|NCT00012012|P1|Participant Flow|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
576713|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576714|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576715|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
576716|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
576717|NCT00012298|O6|Outcome|Treatment: Trial 3, Dose Level 6|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576718|NCT00012298|O5|Outcome|Treatment: Trial 3, Dose Level 5|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 24-36 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000."
576719|NCT00012298|O4|Outcome|Treatment: Trial 2, Dose Level 4|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576720|NCT00012298|O3|Outcome|Treatment: Trial 2, Dose Level 3|"Patients receive:~Cycle 1:~50 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8.~Patients also receive:~480 mcg filgrastim (G-CSF) subcutaneously (SC) daily when ANC is less than 1500.~50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000."
576721|NCT00012298|O2|Outcome|Treatment: Trial 1, Dose Level 2|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.3 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
576722|NCT00012298|O1|Outcome|Treatment: Trial 1, Dose Level 1|"Patients receive:~Cycle 1:~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.4 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8~Cycle 2 (Cycle 2 delivered 12-24 weeks after Cycle 1):~250 mg/m^2 rituximab IV on days 1 and 8, 2 mg (5.0mCi of In-111) Indium (In-111 ibritumomab tiuxetan) IV over 10 minutes on day 1, 0.2 mCi/kg Yttrium (Y-90 ibritumomab tiuxetan (IDEC-90Y2B8) IV over 10 minutes on day 8"
576723|NCT00012298|E7|Reported Event|Treatment : Phase II (Dose Level 6)|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
576724|NCT00012298|E6|Reported Event|Treatment: Trial 3, Dose Level 6|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
576725|NCT00012298|E5|Reported Event|Treatment: Trial 3, Dose Level 5|50 micrograms/kg Interleukin-11 SC when PLT counts less than 150,000.
576726|NCT00012298|E4|Reported Event|Treatment: Trial 2, Dose Level 4|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
576727|NCT00012298|E3|Reported Event|Treatment: Trial 2, Dose Level 3|50 micrograms/kg Interleukin-11 SC when PLT counts less than 75,000.
576782|NCT00010257|P1|Participant Flow|Thymoma|Patients with diagnosis of thymoma
576735|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin and Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
576736|NCT00012012|O1|Outcome|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
576737|NCT00012012|E2|Reported Event|Radiation Therapy Plus Cisplatin & Amifostine|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin and amifostine trihydrate.
576738|NCT00012012|E1|Reported Event|Radiation Therapy Plus Cisplatin|Patients receive extended field external beam radiation therapy (RT) to the para-aortic region and pelvis, intracavitary brachytherapy with concurrent weekly cisplatin.
576739|NCT00011986|B6|Baseline|Total|Total of all reporting groups
576740|NCT00011986|B5|Baseline|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576741|NCT00011986|B4|Baseline|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576742|NCT00011986|B3|Baseline|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
576743|NCT00011986|B2|Baseline|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
576744|NCT00011986|B1|Baseline|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
576745|NCT00011986|P5|Participant Flow|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576746|NCT00011986|P4|Participant Flow|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576747|NCT00011986|P3|Participant Flow|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
576748|NCT00011986|P2|Participant Flow|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
576749|NCT00011986|P1|Participant Flow|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
576750|NCT00011986|O5|Outcome|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576751|NCT00011986|O4|Outcome|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576752|NCT00011986|O3|Outcome|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
576753|NCT00011986|O2|Outcome|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
576754|NCT00011986|O1|Outcome|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
576755|NCT00011986|E5|Reported Event|Carbo/Gemcitabine - Carbo/Taxol|Gemcitabine 1000 mg/m2/dIV on days 1 and 8 plus Carboplatin AUC 6 IV on day 8 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576756|NCT00011986|E4|Reported Event|Carbo/Topotecan - Carbo/Taxol|Topotecan 1.25 mg/m2/dIV days 1-3 plus Carboplatin AUC 5 IV on day 3 plus x 4 cycles followed by Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 4 cycles
576757|NCT00011986|E3|Reported Event|Carbo/Taxol/Doxil|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Doxil 30 mg/m2 IV every other cycle on day 1 x 8 cycles
576758|NCT00011986|E2|Reported Event|Carbo/Taxol/Gemcitabine|Carboplatin AUC 5 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles plus Gemcitabine 800 mg/m2/dIV on days 1 and 8 x 8 cycles
576759|NCT00011986|E1|Reported Event|Carbo/Taxol|Carboplatin AUC 6 IV on day 1 plus Paclitaxel 175 mg/m2 IV on day 1 x 8 cycles
576760|NCT00010803|B3|Baseline|Total|Total of all reporting groups
576761|NCT00010803|B2|Baseline|Placebo|Placebo 1 pill twice daily
576762|NCT00010803|B1|Baseline|Ginkgo Biloba|120 mg twice daily, total 240 mg
576763|NCT00010803|P2|Participant Flow|Placebo|Placebo twice daily
576764|NCT00010803|P1|Participant Flow|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
576765|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
576766|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
576767|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
576768|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
576769|NCT00010803|O2|Outcome|Placebo|Placebo 1 pill twice a day
576770|NCT00010803|O1|Outcome|Ginkgo Biloba|120 mg twice daily, total 240 mg
576771|NCT00010803|E2|Reported Event|Placebo|Placebo twice daily
576772|NCT00010803|E1|Reported Event|Ginkgo Biloba|EGb 761 Ginkgo biloba 120 mg twice daily
576773|NCT00010439|B1|Baseline|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
576774|NCT00010439|P1|Participant Flow|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
576775|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
576776|NCT00010439|O1|Outcome|Alendronate|Ten children will take alendronate 35mg or 70mg weekly depending upon the body weight for 12 months. Patients will also take calcium supplement daily.
576790|NCT00009737|B2|Baseline|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576791|NCT00009737|B1|Baseline|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576792|NCT00009737|P2|Participant Flow|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576793|NCT00009737|P1|Participant Flow|Capecitabine|Participants received capecitabine 1250 milligram per square meter (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576794|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576795|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576796|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576797|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576798|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576799|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576800|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576801|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576802|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576803|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576804|NCT00009737|O2|Outcome|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576805|NCT00009737|O1|Outcome|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576806|NCT00009737|E2|Reported Event|5-Fluorouracil + Leucovorin|Participants received leucovorin 20 mg/m ^ 2 followed by 5-fluorouracil at 425 mg/m ^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
576807|NCT00009737|E1|Reported Event|Capecitabine|Participants received capecitabine 1250 (mg/m ^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
576808|NCT00008385|B3|Baseline|Total|Total of all reporting groups
576809|NCT00008385|B2|Baseline|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576810|NCT00008385|B1|Baseline|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
576811|NCT00008385|P2|Participant Flow|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576812|NCT00008385|P1|Participant Flow|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
576813|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576814|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
576815|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576816|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
576817|NCT00008385|O2|Outcome|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576818|NCT00008385|O1|Outcome|Arm I (Placebo)|"Participants receive an oral yeast placebo as in arm II.~placebo: Given orally"
576819|NCT00008385|E2|Reported Event|Arm II (Selenium)|"Participants receive oral selenium yeast daily for 6 months. Treatment repeats every 6 months for 8 courses for a total of 4 years in the absence of unacceptable toxicity.~selenium: Given orally"
576820|NCT00008385|E1|Reported Event|Arm I (Placebo)|Participants receive an oral yeast placebo as in arm II. placebo: Given orally
577252|NCT00006156|P1|Participant Flow|Drug - FSH|
576821|NCT00008138|B1|Baseline|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
576822|NCT00008138|P1|Participant Flow|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
576823|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
576824|NCT00008138|O1|Outcome|Experimental: Chemo/Debulking Surgery/IP Chemo|neoadjuvant chemotherapy (carboplatin and paclitaxel) followed by debulking surgery followed by intraperitoneal chemotherapy (carboplatin and paclitaxel)
576825|NCT00008138|E2|Reported Event|Post-Cytoreduction Paclitaxel (IV/IP) + Carboplatin (IP)|post-surgery chemotherapy with IV and IP carboplatin and paclitaxel
576826|NCT00008138|E1|Reported Event|Neoadjuvant Paclitaxel (IV) + Carboplatin (V)|Pre-surgery IV chemotherapy with paclitaxel and carboplatin
576827|NCT00007644|B3|Baseline|Total|Total of all reporting groups
576828|NCT00007644|B2|Baseline|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
576829|NCT00007644|B1|Baseline|Radical Prostatectomy|Surgical removal of the prostate
576830|NCT00007644|P2|Participant Flow|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
576831|NCT00007644|P1|Participant Flow|Radical Prostatectomy|Surgical removal of the prostate
576832|NCT00007644|O2|Outcome|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
576833|NCT00007644|O1|Outcome|Radical Prostatectomy|Surgical removal of the prostate
576834|NCT00007644|E2|Reported Event|Watchful Waiting|Closely watching, waiting and treating symptoms if and when cancer progresses
576835|NCT00007644|E1|Reported Event|Radical Prostatectomy|Surgical removal of the prostate
576836|NCT00007475|B4|Baseline|Total|Total of all reporting groups
576837|NCT00007475|B3|Baseline|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of validated FPF assay
576838|NCT00007475|B2|Baseline|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576839|NCT00007475|B1|Baseline|FPF NOT Assayed Provisionally, PE + Cyclophosphamide Completed|Participants not provisionally assayed for FPF, yet still complete both series of protocol treatment: Plasma Exchange (PE) and Cyclophosphamide; note that these form a majority of enrollees due to limited availability of validated FPF assay (such an assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial; see Outcome Measures for more details)
576840|NCT00007475|P4|Participant Flow|Historical Controls|Noted as Group F in study protocol: historical control patients, including patients at NIH or other institutions who have previously undergone renal transplant, for whom stored sera are available, and for whom consent to measure FPF has been can be obtained. In some cases, these measurements have been performed by Dr. Savin under pre-existing protocols and these data are already available.
576841|NCT00007475|P3|Participant Flow|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576842|NCT00007475|P2|Participant Flow|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of provisionally validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576843|NCT00007475|P1|Participant Flow|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants not assayed for FSGS Permeability Factor (FPF) levels pre-treatment (Tx), yet still complete both series of protocol-specified treatment; FPF levels NOT available as its assay has not yet been developed to an extent that it could be applied to all enrollees of this current trial
576844|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
576845|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576846|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
576847|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
576848|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576849|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
576850|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
576851|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576852|NCT00007475|O1|Outcome|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants complete both series of protocol treatment
576853|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
577253|NCT00006156|O2|Outcome|Control|
577254|NCT00006156|O1|Outcome|Drug - FSH|
577255|NCT00006156|O2|Outcome|Control|
576854|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576855|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment: Plasma Exchange + Cyclophosphamide
576856|NCT00007475|O3|Outcome|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Protocol Group D (FPF 0.6 or greater pre-initial Transplant)
576857|NCT00007475|O2|Outcome|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576858|NCT00007475|O1|Outcome|FPF NOT Assayed, Plasma Exchange + Cyclophosphamide Completed|Participants complete both series of protocol treatment, Plasma Exchange and Cyclophosphamide.
576859|NCT00007475|E3|Reported Event|FPF Assayed Pre-Tx as High, PE + Cyclophosphamide Completed|Original protocol Group D (FPF 0.6 or greater pre-initial Transplant)
576860|NCT00007475|E2|Reported Event|FPF Assayed Pre-Tx as Low, PE + Cyclophosphamide Completed|Original protocol Groups A/B/C (FPF < 0.6); group size is limited due to limited availability of validated FPF assay and discrepancy with protocol groups due to low-FPF participants receiving PE and Cyclophosphamide (contrast to protocol Figure 1)
576861|NCT00007475|E1|Reported Event|Plasma Exchange + Cyclophosphamide, Complete Treatment|Participants for whom the Focal Segmental Glomerulosclerosis (FSGS) Permeability Factor, or FPF was not able to be assayed, yet enrolled and completed both protocol-specified interventions: the plasma exchange procedure and treatment by cyclophosphamide.
576862|NCT00007345|B3|Baseline|Total|Total of all reporting groups
576863|NCT00007345|B2|Baseline|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576864|NCT00007345|B1|Baseline|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576865|NCT00007345|P2|Participant Flow|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576866|NCT00007345|P1|Participant Flow|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576867|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576868|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576869|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576870|NCT00007345|O1|Outcome|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576871|NCT00007345|O2|Outcome|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576872|NCT00007345|O1|Outcome|Peripheral T-cell Lymphona (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576873|NCT00007345|E2|Reported Event|Cutaneous T-cell Lymphoma (CTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576874|NCT00007345|E1|Reported Event|Peripheral T-cell Lymphoma (PTCL)|Participants received at least one protocol prescribed dose or higher of Romidepsin intravenously at 14mg/m^2 and at 17.5 mg/m^2 on days 1, 8, and 15 of a 28 day cycle.
576875|NCT00006916|B1|Baseline|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
576876|NCT00006916|P1|Participant Flow|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
576877|NCT00006916|O1|Outcome|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
576901|NCT00006721|O3|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
577256|NCT00006156|O1|Outcome|Drug - FSH|
576878|NCT00006916|E1|Reported Event|Radiation Therapy Followed by Bleomycin Via Ommaya Reservoir|60.0 Gy/30 fractions x 2.0 Gy. Then within 2-6 weeks after completion of radiation therapy or at the time a patient experiences disease progression during or immediately after completion of radiation therapy, if clinically feasible, a modified Ommaya reservoir is implanted with the delivery catheter in the tumor or tumor cyst/cavity. Bleomycin, 15 units per week, is then given via the Ommaya reservoir without interruption for a maximum of two years as long as there is no toxicity above grade 3 or evidence of disease progression.
576879|NCT00006903|B3|Baseline|Total|Total of all reporting groups
576880|NCT00006903|B2|Baseline|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576881|NCT00006903|B1|Baseline|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576882|NCT00006903|P3|Participant Flow|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576883|NCT00006903|P2|Participant Flow|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576884|NCT00006903|P1|Participant Flow|Ineligible|Not eligible
576885|NCT00006903|O2|Outcome|Estrogen Receptor Positive|Estrogen Receptor Postive, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576886|NCT00006903|O1|Outcome|Estrogen Receptor Negative|Estrogen Receptor Negative, Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy
576887|NCT00006903|E1|Reported Event|Faslodex|"Faslodex® 250mg intramuscularly per month, minimum treatment period two cycles until disease progression or adverse effects prohibit further therapy.~Includes both Estrogen Receptor Positive and Estrogen Receptor Negative participants."
576888|NCT00006721|B4|Baseline|Total|Total of all reporting groups
576889|NCT00006721|B3|Baseline|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
576890|NCT00006721|B2|Baseline|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576891|NCT00006721|B1|Baseline|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576892|NCT00006721|P3|Participant Flow|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576893|NCT00006721|P2|Participant Flow|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576894|NCT00006721|P1|Participant Flow|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
576895|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576896|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576897|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576898|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576899|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576900|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576902|NCT00006721|O2|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576903|NCT00006721|O1|Outcome|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the abs ence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
576904|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576905|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576906|NCT00006721|O2|Outcome|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576907|NCT00006721|O1|Outcome|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576908|NCT00006721|E3|Reported Event|CHOP + Tositumomab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 1, 22, 43, 64, 85, and 106. Patients also receive oral prednisone daily on days 1-5, 22-26, 43-47, 64-68, 85-89 and 106-120 and tositumomab (monoclonal antibody anti-B1) IV over 1 hour followed by iodine I 131 tositumomab IV over 20 minutes on days 134 and 141
576909|NCT00006721|E2|Reported Event|CHOP + Rituximab|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on days 8, 29, 50, 71, 92, and 113. Patients also receive oral prednisone daily on days 8-12, 29-33, 50-54, 71-75, 92-96 and 113-117 and rituximab IV over 4-6 hours on days 1, 6, 48, 90, 134, and 141
576910|NCT00006721|E1|Reported Event|CHOP Only|Patients receive cyclophosphamide IV over 15 minutes, doxorubicin IV over 5-20 minutes, and vincristine IV over 5-15 minutes on day 1. Patients also receive oral prednisone daily on days 1-5. Treatment continues every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. (Arm I closed to accrual as of 12/15/02)
576911|NCT00006604|B8|Baseline|Total|Total of all reporting groups
576912|NCT00006604|B7|Baseline|Step I: Group 8 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576913|NCT00006604|B6|Baseline|Step I: Group 7 (ATV Final Dose: 205mg/m^2 Capsule + RTV)|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576914|NCT00006604|B5|Baseline|Step I: Group 6 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576915|NCT00006604|B4|Baseline|Step I: Group 5a (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576916|NCT00006604|B3|Baseline|Step I: Group 5 (ATV Final Dose: 310mg/m^2 Powder + RTV)|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576917|NCT00006604|B2|Baseline|Step I: Group 4 (ATV Final Dose: 620mg/m^2 Capsule)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
576918|NCT00006604|B1|Baseline|Step I: Group 3 (ATV Final Dose: 520mg/m^2 Capsule)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577257|NCT00006156|E1|Reported Event|Adverse Events Not Collected|Adverse Events Not Collected
577258|NCT00006151|B3|Baseline|Total|Total of all reporting groups
576919|NCT00006604|P17|Participant Flow|Group 8: ATV Capsule (205mg/m^2) + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
576920|NCT00006604|P16|Participant Flow|Group 8: ATV Capsule (310mg/m^2) + RTV|Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
576921|NCT00006604|P15|Participant Flow|Group 7: ATV Capsule (205mg/m^2) + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
576922|NCT00006604|P14|Participant Flow|Group 7: ATV Capsule (310mg/m^2) + RTV|Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.
576923|NCT00006604|P13|Participant Flow|Group 6: ATV Powder (310mg/m^2) + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
576924|NCT00006604|P12|Participant Flow|Group 5a: ATV Powder (310mg/m^2) + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
576925|NCT00006604|P11|Participant Flow|Group 5: ATV Powder (310mg/m^2) + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~Note: This is the final recommended dose for this group."
576926|NCT00006604|P10|Participant Flow|Group 4: ATV Capsule (620mg/m^2)|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
576927|NCT00006604|P9|Participant Flow|Group 4: ATV Capsule (520mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
576928|NCT00006604|P8|Participant Flow|Group 4: ATV Capsule (310mg/m^2)|Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.
576929|NCT00006604|P7|Participant Flow|Group 3: ATV Capsule (520mg/m^2)|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~Note: This is the final recommended dose for this group."
576930|NCT00006604|P6|Participant Flow|Group 3: ATV Capsule (415mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.
576931|NCT00006604|P5|Participant Flow|Group 3: ATV Capsule (310mg/m^2)|Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They will received ATV (capsule) and two NRTIs.
576932|NCT00006604|P4|Participant Flow|Group 2: ATV Powder (620mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
576933|NCT00006604|P3|Participant Flow|Group 2: ATV Powder (310mg/m^2)|Group 2 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder) and two NRTIs.
576934|NCT00006604|P2|Participant Flow|Group 1: ATV Dose: Powder (620mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
576935|NCT00006604|P1|Participant Flow|Group 1: ATV Dose: Powder (310mg/m^2)|Group 1 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder) and two NRTIs.
576936|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576937|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576938|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576939|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576940|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576941|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577070|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
576942|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576943|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576944|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576945|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576946|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576947|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576948|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
576949|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576950|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576951|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576952|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576953|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576954|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576955|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577071|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
576956|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576957|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576958|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
576959|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576960|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576961|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576962|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
576963|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576964|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576965|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576966|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576967|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576968|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576969|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577072|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
576970|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576971|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576972|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576973|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576974|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576975|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576976|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
576977|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576978|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576979|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576980|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m2"
576981|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576982|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576983|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577073|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
576984|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576985|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576986|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576987|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576988|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576989|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
576990|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
576991|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2 Capsule"
576992|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576993|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
576994|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576995|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576996|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
576997|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577074|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
576998|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
576999|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577000|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577001|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577002|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577003|NCT00006604|O3|Outcome|Step I: Group 5: ATV 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577004|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577005|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577006|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577007|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577008|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577009|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577010|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577011|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577075|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
577259|NCT00006151|B2|Baseline|Placebo Accu Drop Plus Counseling|Placebo product and systematic cigarette tapering plus counseling
577012|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577013|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577014|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577015|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577016|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577017|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577018|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577019|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577020|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577021|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 205mg/m^2"
577022|NCT00006604|O5|Outcome|Step I: Group 6 : ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577023|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577024|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577025|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577076|NCT00006409|O1|Outcome|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
577260|NCT00006151|B1|Baseline|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
577026|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577027|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577028|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577029|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577030|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577031|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577032|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577033|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577034|NCT00006604|O7|Outcome|Step I: Group 8: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 8 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577035|NCT00006604|O6|Outcome|Step I: Group 7: ATV Dose: 205mg/m^2 Capsule + RTV|"Group 7 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 205mg/m^2"
577036|NCT00006604|O5|Outcome|Step I: Group 6: ATV Dose: 310mg/m^2 Powder + RTV|"Group 6 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577037|NCT00006604|O4|Outcome|Step I: Group 5a: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5a enrolled participants between 91 days of age and 180 days of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended: 310mg/m^2"
577038|NCT00006604|O3|Outcome|Step I: Group 5: ATV Dose: 310mg/m^2 Powder + RTV|"Group 5 enrolled participants between 91 days of age and 2 years of age. They received ATV (powder), ritonavir, and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~Ritonavir: Administered as 100 mg capsules or oral solution.~ATV Final Recommended Dose: 310mg/m^2"
577039|NCT00006604|O2|Outcome|Step I: Group 4: ATV Dose: 620mg/m^2 Capsule|"Group 4 enrolled participants between 13 years and 1 day of age and 21 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 620mg/m^2"
577077|NCT00006409|E6|Reported Event|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577040|NCT00006604|O1|Outcome|Step I: Group 3: ATV Dose: 520mg/m^2 Capsule|"Group 3 enrolled participants between 2 years and 1 day of age and 13 years of age. They received ATV (capsule) and two NRTIs.~ATV: Participants received varying doses of ATV, depending on their age and weight. The medication was administered as 50 mg, 100 mg, or 200 mg capsules or a powder formulation, depending on which study arm participants were in.~ATV Final Recommended Dose: 520mg/m^2"
577041|NCT00006604|E7|Reported Event|Group 5A: ATV 310mg/m^2 Powder + RTV|"91 to 180 days of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
577042|NCT00006604|E6|Reported Event|Group 8: ATV 205mg/m^2 Capsule + RTV|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
577043|NCT00006604|E5|Reported Event|Group 7: ATV 205mg/m^2 Capsule + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
577044|NCT00006604|E4|Reported Event|Group 6: ATV 310mg/m^2 Powder + RTV|"2 years and 1 day (731 days or more) to 13 years of age.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
577045|NCT00006604|E3|Reported Event|Group 5: ATV 310mg/m^2 Powder + RTV|"91 days to 2 years of age (less than or exactly 730 days.~ATV powder + ritonavir + 2 NRTIs~Note: This is the final recommended dose for this group."
577046|NCT00006604|E2|Reported Event|Group 4: ATV 620mg/m^2 Capsule|"13 years and 1 day to 21 (not including the 22nd birthday) years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
577047|NCT00006604|E1|Reported Event|Group 3: ATV 520mg/m^2 Capsule|"2 years and 1 day (731 days or more) to 13 years of age.~ATV capsule + 2 NRTIs~Note: This is the final recommended dose for this group."
577048|NCT00006478|B1|Baseline|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
577049|NCT00006478|P1|Participant Flow|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
577050|NCT00006478|O1|Outcome|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
577051|NCT00006478|E1|Reported Event|Vaccine Therapy|vaccination to beging at day +100 or 6 months after hematopoietic stem cell transplantation. The vaccine will be given every 4 weeks for 7 consecutive doses and will include Idiotype + KLH along with the adjuvant, GMCSF
577052|NCT00006409|B7|Baseline|Total|Total of all reporting groups
577053|NCT00006409|B6|Baseline|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577054|NCT00006409|B5|Baseline|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577055|NCT00006409|B4|Baseline|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577056|NCT00006409|B3|Baseline|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577057|NCT00006409|B2|Baseline|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
577058|NCT00006409|B1|Baseline|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
577059|NCT00006409|P6|Participant Flow|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577060|NCT00006409|P5|Participant Flow|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577061|NCT00006409|P4|Participant Flow|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577062|NCT00006409|P3|Participant Flow|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577063|NCT00006409|P2|Participant Flow|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
577064|NCT00006409|P1|Participant Flow|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
577065|NCT00006409|O6|Outcome|8th-grade/2006 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577066|NCT00006409|O5|Outcome|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577067|NCT00006409|O4|Outcome|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577068|NCT00006409|O3|Outcome|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577069|NCT00006409|O2|Outcome|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
577078|NCT00006409|E5|Reported Event|8th-grade/2006 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 3 years of intervention, including baseline data reported here)"
577079|NCT00006409|E4|Reported Event|8th-grade/2005 - Control|"Cross-sectional sample of 8th-grade girls in schools that were randomized to not receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577080|NCT00006409|E3|Reported Event|8th-grade/2005 - Intervention|"Cross-sectional sample of 8th-grade girls in schools that were randomized to receive the intervention (data collected after 2 years of intervention, including baseline data reported here)"
577081|NCT00006409|E2|Reported Event|6th-grade/2003 - Control|Cross-sectional sample of 6th-grade girls in schools that were randomized to not receive the intervention (data collected at baseline)
577082|NCT00006409|E1|Reported Event|6th-grade/2003 - Intervention|Cross-sectional sample of 6th-grade girls in schools that were randomized to receive the intervention (data collected at baseline)
577083|NCT00006392|B5|Baseline|Total|Total of all reporting groups
577084|NCT00006392|B4|Baseline|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577085|NCT00006392|B3|Baseline|Combination|Vitamin E + selenium
577086|NCT00006392|B2|Baseline|Selenium|Selenium + matching placebo for vitamin E
577087|NCT00006392|B1|Baseline|Vitamin E|Vitamin E + matching placebo for selenium
577088|NCT00006392|P4|Participant Flow|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577089|NCT00006392|P3|Participant Flow|Combination|Vitamin E + selenium
577090|NCT00006392|P2|Participant Flow|Selenium|Selenium + matching placebo for vitamin E
577091|NCT00006392|P1|Participant Flow|Vitamin E|Vitamin E + matching placebo for selenium
577092|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577093|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577094|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577095|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577096|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577097|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577098|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577099|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577100|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577101|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577102|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577103|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577104|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577105|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577106|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577107|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577108|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577109|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577110|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577111|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577112|NCT00006392|O4|Outcome|Placebo|Matching placebo for vitamin E + matching placebo for selenium
577113|NCT00006392|O3|Outcome|Combination|Vitamin E + selenium
577114|NCT00006392|O2|Outcome|Selenium|Selenium + matching placebo for vitamin E
577115|NCT00006392|O1|Outcome|Vitamin E|Vitamin E + matching placebo for selenium
577116|NCT00006392|E4|Reported Event|Vitamin E Alone|Vitamin E + placebo for selenium
577117|NCT00006392|E3|Reported Event|Placebo|Placebo for selenium + placebo for vitamin E
577118|NCT00006392|E2|Reported Event|Combination|Selenium + vitamin E
577119|NCT00006392|E1|Reported Event|Selenium Alone|Selenium + placebo for vitamin E
577120|NCT00006389|B1|Baseline|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577121|NCT00006389|P1|Participant Flow|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577122|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577123|NCT00006389|O1|Outcome|Treatment|"Patients receive bryostatin 1 IV over 72 hours on days 1-3 followed by cisplatin IV over 1 hour on day 4. Treatment repeats every 3 weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577124|NCT00006389|O1|Outcome|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577125|NCT00006389|E1|Reported Event|Treatment|"Patients received byrostatin-1 45µg/m2/day as a 72 hour intravenous infusion followed by a 1-hour infusion of cisplatin 50 mg/m2 on day 4 immediately at the bryostatin-1 infusion, administered every three weeks for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.~bryostatin 1: Given IV~cisplatin: Given IV~laboratory biomarker analysis: Correlative studies"
577127|NCT00006305|B4|Baseline|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
577128|NCT00006305|B3|Baseline|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
577129|NCT00006305|B2|Baseline|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
577130|NCT00006305|B1|Baseline|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
577131|NCT00006305|P4|Participant Flow|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
577132|NCT00006305|P3|Participant Flow|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
577133|NCT00006305|P2|Participant Flow|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
577134|NCT00006305|P1|Participant Flow|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
577135|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
577136|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
577137|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
577138|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
577139|NCT00006305|O4|Outcome|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
577140|NCT00006305|O3|Outcome|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
577141|NCT00006305|O2|Outcome|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
577142|NCT00006305|O1|Outcome|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
577143|NCT00006305|E4|Reported Event|Medical Therapy and Insulin Sensitizing (IS)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin sensitizing glycemic control strategy
577144|NCT00006305|E3|Reported Event|Medical Therapy and Insulin Providing (IP)|Intensive medical therapy with delayed revascularization if clinically indicated and insulin providing glycemic control strategy
577145|NCT00006305|E2|Reported Event|Revascularization and Insulin Sensitizing (IS)|Prompt revascularization with intensive medical therapy and insulin sensitizing glycemic control strategy
577146|NCT00006305|E1|Reported Event|Revascularization and Insulin Providing (IP)|Prompt revascularization with intensive medical therapy and insulin providing glycemic control strategy
577147|NCT00006289|B3|Baseline|Total|Total of all reporting groups
577148|NCT00006289|B2|Baseline|Neurotropin First, Then Placebo|Receive Neurotropin 4 tabs b.i.d. for 5 weeks and then Placebo 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
577149|NCT00006289|B1|Baseline|Placebo First, Then Neurotropin|Receive Placebo 4 tabs b.i.d. for 5 weeks and then Neurotropin 4 tabs b.i.d. for 5 weeks (after at least 1 week washout period)
577150|NCT00006289|P2|Participant Flow|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
577151|NCT00006289|P1|Participant Flow|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
577152|NCT00006289|O4|Outcome|MPQ After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. MPQ was determined at the end of the 5 week-treatment of placebo."
577153|NCT00006289|O3|Outcome|MPQ After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
577154|NCT00006289|O2|Outcome|MPQ After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. MPQ was determined at the end of the 5 week-treatment of Neurotropin."
577155|NCT00006289|O1|Outcome|MPQ After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. MPQ was determined at the end of the 5 week-treatment.
577156|NCT00006289|O4|Outcome|NRS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. NRS was determined at the end of the 5 week-treatment of placebo."
577157|NCT00006289|O3|Outcome|NRS After Neurotropin Treatment First in G-2|This group received Neurotropin 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
577158|NCT00006289|O2|Outcome|NRS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. NRS was determined at the end of the 5 week-treatment of Neurotropin."
577159|NCT00006289|O1|Outcome|NRS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. NRS was determined at the end of the 5 week-treatment.
577160|NCT00006289|O4|Outcome|VAS After Placebo Treatment Second in G-2|"This group received placebo 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on Neurotropin. VAS was determined at the end of the 5 week-treatment of placebo."
577261|NCT00006151|P2|Participant Flow|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
577162|NCT00006289|O2|Outcome|VAS After Neurotropin Treatment Second in G-1|"This group received Neurotropin 4 tabs b.i.d. for 5 weeks after at least 1 week washout period following the first 5 week interval on placebo. VAS was determined at the end of the 5 week-treatment of Neurotropin."
577163|NCT00006289|O1|Outcome|VAS After Placebo Treatment First in G-1|This group received placebo 4 tabs b.i.d. for 5 weeks first. VAS was determined at the end of the 5 week-treatment.
577164|NCT00006289|E2|Reported Event|Neurotropin First, Then Placebo|Receive Neurotropin b.i.d. for 5 weeks and then the placebo b.i.d. for 5 weeks (after at least 1 week washout period)
577165|NCT00006289|E1|Reported Event|Placebo First, Then Neurotropin|Receive the placebo b.i.d. for 5 weeks and then Neurotropin b.i.d. for 5 weeks (after at least 1 week washout period)
577166|NCT00006237|B3|Baseline|Total|Total of all reporting groups
577167|NCT00006237|B2|Baseline|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
577168|NCT00006237|B1|Baseline|Interferon|interferon alfa
577169|NCT00006237|P2|Participant Flow|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
577170|NCT00006237|P1|Participant Flow|Interferon|interferon alfa IV
577171|NCT00006237|O2|Outcome|Biochemotherapy|Biochemotherapy
577172|NCT00006237|O1|Outcome|Interferon|Interferon
577173|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
577174|NCT00006237|O1|Outcome|Interferon|interferon alfa
577175|NCT00006237|O2|Outcome|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
577176|NCT00006237|O1|Outcome|Interferon|interferon alfa IV on days 1-5 of weeks 1-4 followed by interferon alfa subcutaneously (SC) on days 1, 3, and 5 of weeks 5-52 in the absence of disease progression or unacceptable toxicity.
577177|NCT00006237|E2|Reported Event|Biochemotherapy|cisplatin, dacarbazine, interleukin-2, interferon alfa SC, filgrastim
577178|NCT00006237|E1|Reported Event|Interferon|interferon alfa
577179|NCT00006184|B3|Baseline|Total|Total of all reporting groups
577180|NCT00006184|B2|Baseline|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
577181|NCT00006184|B1|Baseline|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
577182|NCT00006184|P2|Participant Flow|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (Anti-idiotype-keyhole limpet hemocyanin) (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
577183|NCT00006184|P1|Participant Flow|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and granulocyte colony stimulating factor ( GCSF) followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
577184|NCT00006184|O2|Outcome|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
577185|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
577186|NCT00006184|O1|Outcome|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
577187|NCT00006184|E2|Reported Event|Donor - Vaccination Generation Group|3 subcutaneous injections of myeloma protein within 10 weeks before stem cell collection. The first (week 0) second (week 2), and third injection (week 6) with Id-KLH (0.5 mg subcutaneous day 1) and Granulocyte macrophage-colony stimulating factor (GM-CSF) (250 mcg/m^2 subcutaneous on days 1-4). Stem cell collection is 4 weeks after the third vaccination
577188|NCT00006184|E1|Reported Event|Recipient - Chemotherapy Group|Induction chemotherapy with fludarabine, etoposide, doxorubicin, vincristine, cyclophosphamide, prednisone, and GCSF followed by transplant preparative regimen chemotherapy with fludarabine, cyclophosphamide, mesna, cyclosporine, and methotrexate, followed by stem cell infusion and immunization.
577189|NCT00006178|B1|Baseline|Sirolimus Monotherapy|
577190|NCT00006178|P1|Participant Flow|Sirolimus Monotherapy|
577191|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
577192|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
577193|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
577194|NCT00006178|O1|Outcome|Sirolimus Monotherapy|
577195|NCT00006178|E1|Reported Event|Sirolimus Monotherapy|
577196|NCT00006170|B5|Baseline|Total|Total of all reporting groups
577197|NCT00006170|B4|Baseline|SS+P|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
577198|NCT00006170|B3|Baseline|SS+B|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
577199|NCT00006170|B2|Baseline|WC+P|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of bupropion.
577200|NCT00006170|B1|Baseline|WC+B|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
577201|NCT00006170|P4|Participant Flow|Social Support + Placebo (SS+P)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took a placebo instead of the bupropion.
577202|NCT00006170|P3|Participant Flow|Social Support + Bupropion (SS+B)|An approach was taken to combine standard cessation therapy with added discussion of smoking topics but no specific weight focus and pharmacotherapy. This group took bupropion, a widely used, efficacious smoking cessation agent.
577203|NCT00006170|P2|Participant Flow|Weight Concerns + Placebo (WC+P)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took a placebo instead of the bupropion.
577204|NCT00006170|P1|Participant Flow|Weight Concerns + Bupropion (WC+B)|An approach was taken to combine cognitive behavioral therapy and pharmacotherapy to women who had weight concerns after cessation. This group took bupropion, a widely used, efficacious smoking cessation agent.
577205|NCT00006170|O4|Outcome|SS+P|
577206|NCT00006170|O3|Outcome|SS+B|
577207|NCT00006170|O2|Outcome|WC+P|
577208|NCT00006170|O1|Outcome|WC+B|
577209|NCT00006170|O4|Outcome|SS+P|
577210|NCT00006170|O3|Outcome|SS+B|
577211|NCT00006170|O2|Outcome|WC+P|
577212|NCT00006170|O1|Outcome|WC+B|
577213|NCT00006170|O4|Outcome|SS+P|
577214|NCT00006170|O3|Outcome|SS+B|
577215|NCT00006170|O2|Outcome|WC+P|
577216|NCT00006170|O1|Outcome|WC+B|
577217|NCT00006170|E4|Reported Event|SS+P|
577218|NCT00006170|E3|Reported Event|SS+B|
577219|NCT00006170|E2|Reported Event|WC+P|
577220|NCT00006170|E1|Reported Event|WC+B|
577221|NCT00006164|B3|Baseline|Total|Total of all reporting groups
577222|NCT00006164|B2|Baseline|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577223|NCT00006164|B1|Baseline|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577224|NCT00006164|P2|Participant Flow|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577225|NCT00006164|P1|Participant Flow|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577226|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577227|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577228|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577229|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577230|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577231|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577232|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577233|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577234|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577235|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577236|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577237|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577238|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577239|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577240|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577241|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577242|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577243|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577244|NCT00006164|O2|Outcome|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577245|NCT00006164|O1|Outcome|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577246|NCT00006164|E2|Reported Event|Standard of Care Followup|Stop any peginterferon alfa-2a/ribavirin therapy and followed prospectively for an additional 42 months without treatment
577247|NCT00006164|E1|Reported Event|Peginterferon Alfa-2a 90 Mcg/Week|Treatment with Peginterferon alfa-2a 90 mcg administered once weekly for an additional 42 months
577248|NCT00006156|B3|Baseline|Total|Total of all reporting groups
577249|NCT00006156|B2|Baseline|Control|
577250|NCT00006156|B1|Baseline|Drug - FSH|
577251|NCT00006156|P2|Participant Flow|Control|
577264|NCT00006151|O1|Outcome|Accu Drop Plus Counseling|Active product and systematic cigarette tapering plus counseling.
577265|NCT00006151|E2|Reported Event|Placebo (PD&C)|The control condition (N=30) will be prescribed placebo Accu Drops (PD&C)
577266|NCT00006151|E1|Reported Event|Accu Drops (AD&C)|The experimental group (N=30) will be prescribed active Accu Drops (AD&C)
577267|NCT00006011|B4|Baseline|Total|Total of all reporting groups
577268|NCT00006011|B3|Baseline|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
577269|NCT00006011|B2|Baseline|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
577270|NCT00006011|B1|Baseline|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
577271|NCT00006011|P3|Participant Flow|Radiation (RT) Only|Tumor volume directed pelvic plus or minus para-aortic irradiation (plus or minus brachytherapy)
577272|NCT00006011|P2|Participant Flow|Arm 2|"Treatment randomization following RT:~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
577273|NCT00006011|P1|Participant Flow|Arm 1|"Treatment randomization following RT.~radiation followed by doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
577274|NCT00006011|O2|Outcome|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
577275|NCT00006011|O1|Outcome|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
577276|NCT00006011|E2|Reported Event|Arm 2|"Treatment randomization following RT:~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 day 1 paclitaxel 3-Hr 160 mg/m2 day 2 G-CSF 5 mcg/kg days 3-12"
577277|NCT00006011|E1|Reported Event|Arm 1|"Treatment randomization following RT.~doxorubicin 45 mg/m2 and cisplatin 50 mg/m2 G-CSF 5mcg/kg Days 2-11"
577278|NCT00005957|B3|Baseline|Total|Total of all reporting groups
577279|NCT00005957|B2|Baseline|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
577280|NCT00005957|B1|Baseline|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
577281|NCT00005957|P2|Participant Flow|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
577282|NCT00005957|P1|Participant Flow|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 centigray (cGy) in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
577283|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
577284|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
577285|NCT00005957|O2|Outcome|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields."
577286|NCT00005957|O1|Outcome|Standard Breast Irradiation|radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.
577287|NCT00005957|E2|Reported Event|Breast Radiation Plus Regional Radiation|"regional radiation therapy (to the ipsilateral supraclavicular, axillary and internal mammary nodes)~Breast Radiation plus Regional Radiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the modified wide tangent fields.~Analysis of adverse events were based on the 893 patients who actually received Breast Radiation plus regional radiation treatment. A total of 5 patients who were randomized to Standard Breast Irradiation and 888 patients who were randomized to Breast Radiation plus regional radiation actually received the Breast Radiation plus regional radiation treatment."
577288|NCT00005957|E1|Reported Event|Standard Breast Irradiation|"radiation therapy: Standard Breast Irradiation - A dose of 5000 cGy in 25 fractions at a rate of 200 cGy per day, 5 days a week for 5 weeks will be prescribed to the standard tangent fields.~Analysis of adverse events were based on the 927 patients who actually received Standard Breast Irradiation treatment. A total of 908 patients who were randomized to Standard Breast Irradiation and 19 patients who were randomized to Breast Radiation plus regional radiation actually received the Standard Breast Irradiation treatment."
577289|NCT00005947|B3|Baseline|Total|Total of all reporting groups
577290|NCT00005947|B2|Baseline|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
577291|NCT00005947|B1|Baseline|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
577292|NCT00005947|P2|Participant Flow|Placebo|"All subjects randomized to receive placebo.~Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals."
577293|NCT00005947|P1|Participant Flow|Sipuleucel-T|"All subjects randomized to receive sipuleucel-T.~Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart."
577294|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
577295|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
577296|NCT00005947|O2|Outcome|Placebo|All subjects randomized to receive placebo
577297|NCT00005947|O1|Outcome|Sipuleucel-T|All subjects randomized to receive sipuleucel-T.
577298|NCT00005947|E2|Reported Event|Placebo|All subjects randomized to receive placebo. Approximately one-third of the quiescent APCs prepared from a single leukapheresis procedure.
577299|NCT00005947|E1|Reported Event|Sipuleucel-T|All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart.
577300|NCT00005937|B1|Baseline|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Antithymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration, the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
577301|NCT00005937|P1|Participant Flow|MDS Subjects Treated With ATG & CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
577302|NCT00005937|O1|Outcome|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
577303|NCT00005937|E1|Reported Event|MDS Subjects Treated With ATG and CsA|Myelodysplastic syndromes (MDS) subjects will be treated with Anti-thymocyte Globulin (ATG) and cyclosporine (CsA). The subjects will receive ATG at a dose of 40mg/kg orally on days 1-4 in combination with oral prednisone at a dose of 1mg/kg/day on day one. The prednisone will be tapered on day 10. The taper schedule will be every two days over a total of eight days (days 10-17). Drug the ATG administration the subjects will receive at least 4 units of platelets daily for platelet counts less than 20,000/ microliters. Cyclosporine (CsA) will be started on day 14 at a dose of 5mg/kg twice daily with dose adjustments based on drug levels (target 200-400 ng/ml). Cyclosporine therapy will be continued for six months.
577304|NCT00005908|B1|Baseline|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
577305|NCT00005908|P2|Participant Flow|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
577306|NCT00005908|P1|Participant Flow|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
577307|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1 & 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
577308|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1, capecitabine 937.5 mg/m^2 orally twice daily day 2-15
577309|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles
577310|NCT00005908|O1|Outcome|Dose A & B-Cohort 1 & 2-Arm 1& 2-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
577311|NCT00005908|O2|Outcome|Dose B-Cohort 2-Arm 2 Reduced Dose-Docetaxel & Capecitabine|Docetaxel 60 mg/m^2 intravenous day 1 capecitabine 937.5 mg/m^2 orally twice daily day 2-15
577312|NCT00005908|O1|Outcome|Dose A-Cohort 1-Arm 1-Docetaxel & Capecitabine|Docetaxel 75 mg/m^2 intravenous day 1, capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles Once the dose was deemed to be too toxic, subsequent patients were enrolled on dose B.
577313|NCT00005908|E1|Reported Event|Docetaxel/Capecitabine - A & B|Docetaxel/Capecitabine - A- Docetaxel 75 mg/m^2 intravenous day 1,capecitabine 1000 mg/m^2 orally twice daily day 2-15 for 4 cycles. Docetaxel/Capecitabine - B- Docetaxel 60 mg/m2 intravenous day 1 capecitabine 937.5 mg/m2 orally twice daily day 2-15
577314|NCT00005906|B1|Baseline|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577315|NCT00005906|P1|Participant Flow|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577316|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577317|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577318|NCT00005906|O1|Outcome|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577319|NCT00005906|E1|Reported Event|Octreotide|Patients with lymphangioleiomyomatosis and lymphatic tumors causing chylous effusions and abdominal pain
577320|NCT00005901|B3|Baseline|Total|Total of all reporting groups
577321|NCT00005901|B2|Baseline|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
577322|NCT00005901|B1|Baseline|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
577323|NCT00005901|P2|Participant Flow|Active Comparator: 2|Receives treatment every 6 months.
577324|NCT00005901|P1|Participant Flow|Active Comparator: 1|Receives treatment every 3 months
577325|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577326|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577327|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577328|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577329|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577330|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577331|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577332|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577333|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577334|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577335|NCT00005901|O2|Outcome|Pamidronate Every 6 Months for 3 Years|Subjects who received Pamidronate every 6 months for 3 years.
577336|NCT00005901|O1|Outcome|Pamidronate Every 3 Months for 3 Years|Subjects who received Pamidronate every 3 months for 3 years.
577337|NCT00005901|E2|Reported Event|Active Comparator: 2|Subjects who received Pamidronate every 6 months for 3 years.
577338|NCT00005901|E1|Reported Event|Active Comparator: 1|Subjects who received Pamidronate every 3 months for 3 years.
577339|NCT00005669|B3|Baseline|Total|Total of all reporting groups
577340|NCT00005669|B2|Baseline|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577341|NCT00005669|B1|Baseline|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577342|NCT00005669|P2|Participant Flow|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577343|NCT00005669|P1|Participant Flow|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577344|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577345|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577346|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577347|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577348|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577349|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577350|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577351|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577352|NCT00005669|O2|Outcome|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577353|NCT00005669|O1|Outcome|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577354|NCT00005669|E2|Reported Event|Placebo Plus Weight Reduction Counseling|Subjects receive increasing doses of placebo to the maximum of 2000 mg per day (placebo supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577355|NCT00005669|E1|Reported Event|Metformin Plus Weight Reduction Counseling|Subjects receive increasing doses of metformin to the maximum of 2000 mg per day (metformin supplied as 250 mg capsules administered with breakfast and dinner) plus a weight loss program
577356|NCT00004980|B3|Baseline|Total|Total of all reporting groups
577357|NCT00004980|B2|Baseline|Placebo|Participants received sham stimulation
577358|NCT00004980|B1|Baseline|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577359|NCT00004980|P2|Participant Flow|Placebo|Participants received sham stimulation
577360|NCT00004980|P1|Participant Flow|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577361|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
577362|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577363|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
577364|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577365|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
577366|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577367|NCT00004980|O2|Outcome|Placebo|Participants received sham stimulation
577368|NCT00004980|O1|Outcome|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577369|NCT00004980|E2|Reported Event|Placebo|Participants received sham stimulation
577370|NCT00004980|E1|Reported Event|Active Repetitive Transcanial Magnetic Stimulation|Participants received active repetitive transcranial magnetic stimulation (rTMS)
577371|NCT00004978|B3|Baseline|Total|Total of all reporting groups
577372|NCT00004978|B2|Baseline|No rIL-2|Control group - no study-assigned medication
577373|NCT00004978|B1|Baseline|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577374|NCT00004978|P2|Participant Flow|No rIL-2|Control group - no study-assigned medication
577375|NCT00004978|P1|Participant Flow|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577376|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577377|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577378|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577379|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577380|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577381|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577382|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577383|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577384|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577385|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577386|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577387|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577388|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577389|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577390|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577391|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577392|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577393|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577394|NCT00004978|O2|Outcome|No rIL-2|Control group - no study-assigned medication
577395|NCT00004978|O1|Outcome|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577396|NCT00004978|E2|Reported Event|No rIL-2|Control group - no study-assigned medication
577397|NCT00004978|E1|Reported Event|rIL-2|Subcutaneous recombinant interleukin-2 (rIL-2) therapy
577398|NCT00004888|B3|Baseline|Total|Total of all reporting groups
577399|NCT00004888|B2|Baseline|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577400|NCT00004888|B1|Baseline|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577401|NCT00004888|P2|Participant Flow|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577402|NCT00004888|P1|Participant Flow|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577403|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577404|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577506|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577405|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577406|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577407|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577408|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577409|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577410|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577411|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577412|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577413|NCT00004888|O2|Outcome|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577414|NCT00004888|O1|Outcome|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577415|NCT00004888|E2|Reported Event|Arm II: Doxorubicin, Taxotere, and Herceptin|Patients received the weekly antibody therapy with trastuzumab in addition to the induction chemotherapy with PLD and docetaxel every 3 weeks as outlined for Arm I above for a total of 8 cycles. Trastuzumab was administered 4 mg/kg IV on Day 1, then 2 mg/kg IV weekly.
577416|NCT00004888|E1|Reported Event|Arm I: Doxorubicin and Taxotere|Patients received PLD 30 mg/m^2 IV followed by docetaxel 60 mg/m^2 IV, one hour after PLD completion, every 3 weeks for a total of 8 cycles. Dexamthasone 8 mg orally twice a day was administered the day before, the day of, and the day following docetaxel. The maximum allowed cumulative dose of PLD was 240 mg/m^2. Pyridoxine 200 mg PO daily started on Day 1 of Cycle 1 and continued daily while the patient was on PLD.
577417|NCT00004859|B3|Baseline|Total|Total of all reporting groups
577418|NCT00004859|B2|Baseline|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
577419|NCT00004859|B1|Baseline|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
577420|NCT00004859|P2|Participant Flow|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
577421|NCT00004859|P1|Participant Flow|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
577422|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
577423|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
577424|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
577425|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
577426|NCT00004859|O2|Outcome|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|experimental arm
577427|NCT00004859|O1|Outcome|Arm A (Paclitaxel + Carboplatin + Radiation )|active comparator
577507|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
577428|NCT00004859|E2|Reported Event|Arm B (Paclitaxel + Carboplatin + Radiation + Thalidomide)|"Experimental arm. Thalidomide: daily, patients begin with 200 mg thalidomide PO as a single dose at bedtime. The dose is then increased by 100 mg every week as tolerated up to a total dose of 1000 mg; low dose aspirin: 81mg PO daily.~Paclitaxel, carboplatin and radiation same as active comparator."
577429|NCT00004859|E1|Reported Event|Arm A (Paclitaxel + Carboplatin + Radiation )|Active comparator. Induction dosing: Paclitaxel, 225 mg/m²; Carboplatin, AUC=6.0. Concurrent dosing: Paclitaxel, 45 mg/m2; Carboplatin: AUC=2.
577430|NCT00004732|B3|Baseline|Total|Total of all reporting groups
577431|NCT00004732|B2|Baseline|Carotid Endarterectomy|Patients Randomized to CEA
577432|NCT00004732|B1|Baseline|Carotid-Artery Stenting|Patients Randomized to CAS
577433|NCT00004732|P2|Participant Flow|Carotid Endarterectomy (CEA)|CEA involves a neck incision and physical removal of the plaque from the inside of the carotid artery.
577434|NCT00004732|P1|Participant Flow|Carotid-Artery Stenting (CAS)|CAS involves insertion of a catheter or tube into an artery in the groin and then threading the catheter through the arteries of the body to the location of the plaque within the carotid artery in the neck. The stent is then placed to cover the plaque and hold the artery open.
577435|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients randomized to CEA
577436|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients randomized to CAS
577437|NCT00004732|O2|Outcome|Carotid Endarterectomy|Patients Randomized to CEA
577438|NCT00004732|O1|Outcome|Carotid-Artery Stenting|Patients Randomized to CAS
577439|NCT00004732|E2|Reported Event|Carotid Endarterectomy|Patients Randomized to CEA
577440|NCT00004732|E1|Reported Event|Carotid-Artery Stenting|Patients Randomized to CAS
577441|NCT00004635|B3|Baseline|Total|Total of all reporting groups
577442|NCT00004635|B2|Baseline|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
577443|NCT00004635|B1|Baseline|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
577444|NCT00004635|P2|Participant Flow|Placebo Followed by Thalidomide|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received placebo for thalidomide. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received thalidomide 200 mg once a day.
577445|NCT00004635|P1|Participant Flow|Thalidomide Followed by Placebo|Study participants are randomly assigned to one of two treatment groups. Participants received leuprolide or goserelin for 6 months. In period 1 participants received thalidomide orally 200 mg a day. Patients will be followed until PSA progression defined as prostate-specific antigen (PSA) level that returns to what it was before beginning leuprolide or goserelin or to 5 nanograms per liter, whichever is lower. The participants are returned to the leuprolide or goserelin treatment for 6 months. In period 2 participants received the placebo for thalidomide once a day.
577446|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2.
577447|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
577448|NCT00004635|O2|Outcome|Placebo|Participants who received placebo in period 1 or 2
577449|NCT00004635|O1|Outcome|Thalidomide|Participants who received thalidomide in period 1 or 2.
577450|NCT00004635|E4|Reported Event|Leuprolide|
577451|NCT00004635|E3|Reported Event|Goserelin (Zoladex)|
577452|NCT00004635|E2|Reported Event|Placebo|
577453|NCT00004635|E1|Reported Event|Thalidomide|
577454|NCT00004563|B3|Baseline|Total|Total of all reporting groups
577455|NCT00004563|B2|Baseline|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577456|NCT00004563|B1|Baseline|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577457|NCT00004563|P2|Participant Flow|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577458|NCT00004563|P1|Participant Flow|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577459|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577460|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577461|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577462|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577463|NCT00004563|O2|Outcome|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577464|NCT00004563|O1|Outcome|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577465|NCT00004563|E2|Reported Event|Placebo|"Matching gel caps at a dose of 25 mg~Placebo: Matching gelcaps 25 mgs"
577466|NCT00004563|E1|Reported Event|Cylophosphamide|"Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram.~Cyclophosphamide: Cyclophosphamide (Cytoxan, Bristol-Myers Squibb) was initiated with a dose of 1 mg per kilogram of body weight per day (to the nearest 25 mg). The doses were increased monthly by one capsule up to 2 mg per kilogram."
577467|NCT00004562|B3|Baseline|Total|Total of all reporting groups
577468|NCT00004562|B2|Baseline|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
577469|NCT00004562|B1|Baseline|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
577470|NCT00004562|P2|Participant Flow|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
577471|NCT00004562|P1|Participant Flow|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
577472|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
577473|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
577474|NCT00004562|O2|Outcome|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
577475|NCT00004562|O1|Outcome|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
577476|NCT00004562|E2|Reported Event|Medical Therapy Group|Conventional medical management, including aspirin, beta blockers, angiotensin converting enzyme (ACE) inhibitors, and risk factor modification, plus percutaneous coronary intervention and coronary stenting
577477|NCT00004562|E1|Reported Event|Percutaneous Coronary Intervention Group|Percutaneous Coronary Intervention with stent placement and optimal medical therapy
577478|NCT00004547|B4|Baseline|Total|Total of all reporting groups
577479|NCT00004547|B3|Baseline|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577480|NCT00004547|B2|Baseline|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577481|NCT00004547|B1|Baseline|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577482|NCT00004547|P3|Participant Flow|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577483|NCT00004547|P2|Participant Flow|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577484|NCT00004547|P1|Participant Flow|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577485|NCT00004547|O2|Outcome|Tumor Tissue|Diseased tissue
577486|NCT00004547|O1|Outcome|Normal Tissue|Non-diseased tissue
577508|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577509|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
577487|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577488|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577489|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577490|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577491|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577492|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577493|NCT00004547|O1|Outcome|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
577494|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577495|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577496|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577497|NCT00004547|O3|Outcome|Adenocarcinoma of Gastrointestinal Origin|Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer , tend to be more invasive into tissues and can more readily metastasize to distant sites. The cause of death is usually directly related to intraperitoneal progression of tumor. It is a more difficult group of patients to treat with intraperitoneal therapy because of the aggressive and invasive nature of the tumors.
577498|NCT00004547|O2|Outcome|Low Grade Mucinous Adenocarcinoma|Low grade mucinous adenocarcinoma also includes low grade mucinous neoplasms of borderline malignant potential. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. The majority of patients with truly malignant disease will die of complications from intraperitoneal progression of tumor within 2 to 5 years. The tumors are often surface oriented within the peritoneal cavity without metastases to other distant sites. The most common origin for this type of tumor is the appendix and ovary.
577499|NCT00004547|O1|Outcome|Peritoneal Mesothelioma|Patients with peritoneal mesothelioma suffer with intractable ascites but have a very surface oriented tumor which usually does not invade into organs and cause organ dysfunction. The main source of symptoms and cause of death is intractable ascites.
577500|NCT00004547|E1|Reported Event|Mesothelioma, Low Grade, and Adenocarcinoma|Patients with peritoneal mesothelioma suffer with intractable ascites. Patients with low grade mucinous adenocarcinoma can have prolonged survival with debulking surgery alone. Adenocarcinoma of gastrointestinal origin also includes other than low grade mucinous. Aggressive gastrointestinal adenocarcinomas such as gastric, small bowel, and colon cancer, tend to be more invasive.
577501|NCT00004500|B3|Baseline|Total|Total of all reporting groups
577502|NCT00004500|B2|Baseline|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577503|NCT00004500|B1|Baseline|Lucinactant|Lucinactant via bronchoaveolar lavage
577504|NCT00004500|P2|Participant Flow|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577505|NCT00004500|P1|Participant Flow|Lucinactant|Lucinactant via bronchoaveolar lavage
577656|NCT00003782|B2|Baseline|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
577510|NCT00004500|O2|Outcome|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577511|NCT00004500|O1|Outcome|Lucinactant|Lucinactant via bronchoaveolar lavage
577512|NCT00004500|E2|Reported Event|Standard Care|Standard Care included the use of oxygen, CMV, sedation, paralysis, vasopressors, and/or alkalinization
577513|NCT00004500|E1|Reported Event|Lucinactant|Lucinactant via bronchoaveolar lavage
577514|NCT00004412|B4|Baseline|Total|Total of all reporting groups
577515|NCT00004412|B3|Baseline|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Standard local care dressing only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
577516|NCT00004412|B2|Baseline|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
577517|NCT00004412|B1|Baseline|Standard Local Care Dressing|Standard local care dressing including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
577518|NCT00004412|P3|Participant Flow|Crossover|Patients are randomly assigned (following a table of random numbers prepared by a blinded statistician) between two arms of the study. Arm I is Allevyn Hydrophilic PU dressing (standard local care) only, and Arm II is standard local care plus Arginine Butyrate (AB), the Investigational New Drug. Ulcers observed & traced weekly. Ulcer area calculated by computerized planimetry. After 12 weeks of therapy, if the ulcer size decreased by at least 25%, the AB may be continued for another 8 weeks (twice), or until the ulcer closes, plus an additional 2 weeks. The patients randomized to the Control Arm ( standard local care) were given the option of crossing over to Arm II If, ulcers did not close after 8 weeks of standard local care.
577519|NCT00004412|P2|Participant Flow|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
577520|NCT00004412|P1|Participant Flow|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
577521|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
577522|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
577523|NCT00004412|O2|Outcome|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
577524|NCT00004412|O1|Outcome|Standard Local Care Dressing|Standard local care includng cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
577525|NCT00004412|E2|Reported Event|Arginine Butyrate|Arginine Butyrate IV plus Standard local care dressing for a total of 12 weeks. Low dose 250 mg/kg or, increased dose 750 mg/kg. First week AB given 5 days in a row, over 8 to 12hours.
577526|NCT00004412|E1|Reported Event|Standard Local Care Dressing|Standard local care including cleaning, saline irrigation, dressing changes only for 8 weeks twice a week.
577527|NCT00004228|B8|Baseline|Total|Total of all reporting groups
577528|NCT00004228|B7|Baseline|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577529|NCT00004228|B6|Baseline|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577530|NCT00004228|B5|Baseline|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577531|NCT00004228|B4|Baseline|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577532|NCT00004228|B3|Baseline|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577533|NCT00004228|B2|Baseline|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
577534|NCT00004228|B1|Baseline|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
577535|NCT00004228|P7|Participant Flow|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577536|NCT00004228|P6|Participant Flow|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577537|NCT00004228|P5|Participant Flow|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577538|NCT00004228|P4|Participant Flow|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577539|NCT00004228|P3|Participant Flow|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577540|NCT00004228|P2|Participant Flow|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
577541|NCT00004228|P1|Participant Flow|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
577542|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577543|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577544|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577545|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577546|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577547|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
577548|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
577549|NCT00004228|O7|Outcome|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577550|NCT00004228|O6|Outcome|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577585|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577551|NCT00004228|O5|Outcome|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577552|NCT00004228|O4|Outcome|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577553|NCT00004228|O3|Outcome|A2 (Disseminated, No CNS - CCG Mod BFM w/ Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577554|NCT00004228|O2|Outcome|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
577555|NCT00004228|O1|Outcome|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
577556|NCT00004228|E7|Reported Event|B1 (NHL/BFM-95 w/Out Intens) Additional Enrollment|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577557|NCT00004228|E6|Reported Event|B1 (Disseminated CNS-) NHL/BFM-95 w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577558|NCT00004228|E5|Reported Event|B2 (Disseminated,CNS- (< Amend 7B)) NHL/BFM-95 w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577559|NCT00004228|E4|Reported Event|B2 (CNS+) NHL/BFM-95 w/Intens Delayed Radiation Therapy|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate, Leucovorin Calcium). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate)
577586|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577655|NCT00003782|B3|Baseline|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
577560|NCT00004228|E3|Reported Event|A2 (Disseminated, No CNS - CCG Mod BFM w/Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, Cyclophosphamide, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Cyclophosphamide, daunorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Mercaptopurine, Methotrexate, Intrathecal Methotrexate).
577561|NCT00004228|E2|Reported Event|A1 (Disseminated, No CNS - CCG Mod BFM w/Out Intens|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, doxorubicin hydrochloride, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, prednisone, Methotrexate, Intrathecal Methotrexate)
577562|NCT00004228|E1|Reported Event|A0 (Localized Disease Stg I/II) Modified CCG BFM|Phase I - 5 week induction (Vincristine Sulfate, daunorubicin hydrochloride, L-Asparaginase, Intrathecal Cytarabine, Intrathecal Methotrexate, Prednisone). Phase II - 5 week consolidation (Mercaptopurine, Cyclophosphamide, Cytarabine, Intrathecal Methotrexate, Prednisone). Phase III - 8 week Interim Maintenance (Mercaptopurine, Methotrexate, Intrathecal Methotrexate). Phase IV - 7 week Delayed Intensification (Vincristine Sulfate, Doxorubicin, L-Asparaginase, Dexamethasone, Cyclophosphamide, Thioguanine, Cytarabine, Intrathecal Methotrexate). Phase V - 12 week courses (Vincristine Sulfate, Prednisone, Methotrexate, Intrathecal Methotrexate)
577563|NCT00004146|B1|Baseline|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577564|NCT00004146|P1|Participant Flow|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577565|NCT00004146|O2|Outcome|CAI With RT Without Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577566|NCT00004146|O1|Outcome|CAI With RT + Enzyme Inducing Anticonvulsants|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577567|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577568|NCT00004146|O1|Outcome|CAI With RT - Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577569|NCT00004146|E1|Reported Event|Arm 1|"CAI with RT~carboxyamidotriazole :~CAI : CAI 250 mg PO plus RT followed by 4wks CAI alone followed by 8wks CAI then MRI if stable or better continue until progression and then follow for survival~radiation therapy :"
577570|NCT00004143|B1|Baseline|All Patients|
577571|NCT00004143|P1|Participant Flow|All Patients|
577572|NCT00004143|O1|Outcome|All Patients|
577573|NCT00004143|O1|Outcome|All Patients|
577574|NCT00004143|O1|Outcome|All Patients|
577575|NCT00004143|O1|Outcome|All Patients|
577576|NCT00004143|O1|Outcome|All Patients|
577577|NCT00004143|O1|Outcome|All Patients|
577578|NCT00004143|E1|Reported Event|All Patients|
577579|NCT00004092|B3|Baseline|Total|Total of all reporting groups
577580|NCT00004092|B2|Baseline|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577581|NCT00004092|B1|Baseline|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577582|NCT00004092|P2|Participant Flow|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577583|NCT00004092|P1|Participant Flow|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577584|NCT00004092|O2|Outcome|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577587|NCT00004092|O1|Outcome|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577588|NCT00004092|E2|Reported Event|Arm II (STAMP V)|"Patients receive cyclophosphamide 1.5 g/m2/day IV, carboplatin 200 mg/m2/day IV, and thiotepa 125 mg/m2/day IV over 24 hours on days -7 to -4. PBSC are reinfused on day -2 and 0 and G-CSF at 5ug/kg IV is administered as in arm I.~filgrastim: Given IV or subcutaneously~carboplatin: Given IV~cyclophosphamide: Given IV~thiotepa: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577589|NCT00004092|E1|Reported Event|Arm I (ACT)|"Patients receive 41.25 mg/m2 of doxorubicin IV over 24 hours on days -9 to -6, 100 mg/kg of cyclophosphamide IV over 2 hours on day -5, and 725 mg/m2 of paclitaxel IV over 24 hours on day -4. PBSC are reinfused on days -2 and 0. G-CSF at 5 ug/kg IV is administered beginning on day 0 and continuing until blood counts recover.~filgrastim: Given IV or subcutaneously~cyclophosphamide: Given IV~doxorubicin hydrochloride: Given IV~paclitaxel: Given IV~peripheral blood stem cell transplantation: Patients receive autologous peripheral blood stem cells"
577590|NCT00004054|B3|Baseline|Total|Total of all reporting groups
577591|NCT00004054|B2|Baseline|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
577592|NCT00004054|B1|Baseline|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
577593|NCT00004054|P2|Participant Flow|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
577594|NCT00004054|P1|Participant Flow|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
577595|NCT00004054|O2|Outcome|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]) and estramustine phosphate sodium, etoposide, paclitaxel, and warfarin [Coumadin®]. AS will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
577596|NCT00004054|O1|Outcome|Hormones and RT|Androgen suppression (AS) (Luteinizing hormone releasing hormone [LHRH] agonist and bicalutamide [Casodex] or flutamide [Eulexin]) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and bicalutamide [Casodex] or flutamide [Eulexin]). AS will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of radiation therapy (RT).
577597|NCT00004054|E2|Reported Event|Hormones and RT Plus Chemotherapy|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin) and chemotherapy. Androgen suppression will continue for a total of 24 months from initiation all treatment. Oral antiandrogen will be discontinued at the end of RT.
577598|NCT00004054|E1|Reported Event|Hormones and RT|AS (LHRH agonist and Casodex or Eulexin) x 8 weeks followed by RT to 70.2 Gy with concurrent AS (LHRH agonist and Casodex or Eulexin). Androgen suppression will continue for a total of 24 months from initiation of all treatment. Oral anti-androgen will be discontinued at the end of RT.
577599|NCT00003910|B1|Baseline|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
577600|NCT00003910|P2|Participant Flow|Cyclophosphomide|Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
577601|NCT00003910|P1|Participant Flow|Methotrexate|"MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. If patient had a partial response, MTX was continued for up to 1 year. If patient had CR, MTX was continued for 1 month.~If no response, then pt went onto step 2 and received CY."
577602|NCT00003910|O1|Outcome|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
577603|NCT00003910|E2|Reported Event|Cyclophosphamide|step 2 patients who received CY
577604|NCT00003910|E1|Reported Event|Methotrexate|MTX given orally at 10 mg/m2 in divided doses once weekly. Prednisone was given orally at 1 mg/kg per day for 30 days and then tapered off in the subsequent 24 days. Patients not responding to MTX after 4 months received Cy orally at 100 mg daily in step two with the same prednisone schedule.
577605|NCT00003907|B3|Baseline|Total|Total of all reporting groups
577606|NCT00003907|B2|Baseline|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577651|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577652|NCT00003869|E2|Reported Event|Placebo|250 mg placebo administered daily
577607|NCT00003907|B1|Baseline|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577608|NCT00003907|P2|Participant Flow|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577609|NCT00003907|P1|Participant Flow|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577610|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577611|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577612|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577613|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577614|NCT00003907|O2|Outcome|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577615|NCT00003907|O1|Outcome|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577616|NCT00003907|E2|Reported Event|Neuroendocrine Hepatic Metastases|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577617|NCT00003907|E1|Reported Event|Hepatocellular Carcinoma|Chemoemulsion (doxorubicin, mitomycin and cisplatin) followed by embolization. The entire procedure will be repeated separately to each involved lobe beginning within 8 weeks of the last lobar chemoembolization.
577618|NCT00003901|B1|Baseline|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
577619|NCT00003901|P1|Participant Flow|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
577620|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
577621|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
577622|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
577623|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
577624|NCT00003901|O2|Outcome|OM Positive in Bone Marrow|Participants who had OM in bone marrow.
577625|NCT00003901|O1|Outcome|OM Negative in Bone Marrow|Participants who did not have OM in bone marrow.
577626|NCT00003901|O2|Outcome|OM Positive in Lymph Nodes|Participants who had OM in lymph nodes.
577627|NCT00003901|O1|Outcome|OM Negative in Lymph Nodes|Participants who did not have OM in lymph nodes.
577628|NCT00003901|E1|Reported Event|Surgery|All patients undergo complete lymph node sampling or dissection. Patients are followed at 1, 4, 8, and 12 months, every 6 months for 2 years, and then annually for 2 years.
577629|NCT00003896|B1|Baseline|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
577630|NCT00003896|P1|Participant Flow|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
577631|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Liposomal Doxorubicin|
577632|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
577633|NCT00003896|O1|Outcome|Paclitaxel/CDDP/Lipo Doxorubicin|intravenous paclitaxel (day 1), intraperitoneal cisplatin (day 2), intraperitoneal paclitaxel and intravenous liposomal doxorubicin (day 8)
577634|NCT00003896|E1|Reported Event|Paclitaxel/CDDP/Liposomal Doxorubicin|
577635|NCT00003869|B3|Baseline|Total|Total of all reporting groups
577636|NCT00003869|B2|Baseline|Placebo|250 mg placebo administered daily
577637|NCT00003869|B1|Baseline|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577638|NCT00003869|P2|Participant Flow|Placebo|250 mg placebo administered daily
577639|NCT00003869|P1|Participant Flow|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577640|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577641|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577642|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577643|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577644|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577645|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577646|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577647|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577648|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577649|NCT00003869|O1|Outcome|Carboxyamidotriazole|250 mg carboxyamidotriazole administered daily
577650|NCT00003869|O2|Outcome|Placebo|250 mg placebo administered daily
577657|NCT00003782|B1|Baseline|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
577658|NCT00003782|P3|Participant Flow|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
577659|NCT00003782|P2|Participant Flow|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
577660|NCT00003782|P1|Participant Flow|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
577661|NCT00003782|O3|Outcome|Arm 3: Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
577662|NCT00003782|O2|Outcome|Arm 2: Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
577663|NCT00003782|O1|Outcome|Arm 1: Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
577664|NCT00003782|E3|Reported Event|Doxorubicin + Docetaxel + Cyclophosphamide|Doxorubicin + Docetaxel + Cyclophosphamide
577665|NCT00003782|E2|Reported Event|Doxorubicin + Docetaxel|Doxorubicin + Docetaxel
577666|NCT00003782|E1|Reported Event|Doxorubicin + Cyclophosphamide, Then Docetaxel|Doxorubicin + Cyclophosphamide, then Docetaxel
577667|NCT00003726|B1|Baseline|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
577668|NCT00003726|P1|Participant Flow|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
577669|NCT00003726|O1|Outcome|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
577670|NCT00003726|E1|Reported Event|Lepirudin|Dose level 1: 10 mg once daily -> (total dose, 10 mg/d) Dose level 2: 15 mg once daily -> (total dose, 15 mg/d) Dose level 3: 10 mg twice daily -> (total dose, 20 mg/d) Dose level 4: 15 mg twice daily -> (total dose, 30 mg/d) Dose level 5. 20 mg twice daily -> (total dose, 40 mg/d) Dose level 6: 25 mg twice daily -> (total dose, 50 mg/d)
577671|NCT00003659|B1|Baseline|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577672|NCT00003659|P1|Participant Flow|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577673|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577674|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577675|NCT00003659|O1|Outcome|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577676|NCT00003659|E1|Reported Event|Intermediate or High Risk Chronic Lymphocytic Leukemia|This is a single-arm open-label pilot study designed to assess the antileukemic activity of a regimen containing sequential administration of fludarabine, high-dose cyclophosphamide, and rituximab.
577677|NCT00003641|B3|Baseline|Total|Total of all reporting groups
577678|NCT00003641|B2|Baseline|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
577679|NCT00003641|B1|Baseline|Observation|Patients undergo observation for 4 weeks.
577680|NCT00003641|P2|Participant Flow|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
577681|NCT00003641|P1|Participant Flow|Observation|Patients undergo observation for 4 weeks.
577682|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
577683|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
577684|NCT00003641|O2|Outcome|Interferon Alfa-2b|"Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days. Treatment repeats weekly for 4 weeks in the absence of unacceptable toxicity.~interferon alfa-2b: Given IV"
577685|NCT00003641|O1|Outcome|Observation|Patients undergo observation for 4 weeks.
577686|NCT00003641|E2|Reported Event|Interferon Alfa-2b|Patients receive high-dose interferon alfa-2b IV over 20 minutes daily for 5 consecutive days
577687|NCT00003641|E1|Reported Event|Observation|Patients undergo observation for 4 weeks
577688|NCT00003631|B4|Baseline|Total|Total of all reporting groups
577689|NCT00003631|B3|Baseline|Group C - Unfavorable Prognostic Group|
577690|NCT00003631|B2|Baseline|Group B - Intermediate Prognostic Group|
577691|NCT00003631|B1|Baseline|Group A - Favorable Prognostic Group|
577692|NCT00003631|P3|Participant Flow|Group C - Unfavorable Prognostic Group|
577693|NCT00003631|P2|Participant Flow|Group B - Intermediate Prognostic Group|
577694|NCT00003631|P1|Participant Flow|Group A - Favorable Prognostic Group|
577695|NCT00003631|O3|Outcome|Group C - Unfavorable Prognostic Group|
577696|NCT00003631|O2|Outcome|Group B - Intermediate Prognostic Group|
577697|NCT00003631|O1|Outcome|Group A - Favorable Prognostic Group|
577698|NCT00003631|E3|Reported Event|Group C - Unfavorable Prognostic Group|
577701|NCT00003590|B1|Baseline|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
577702|NCT00003590|P1|Participant Flow|Hydroxyurea|"Only eligible patients were included in the analyses.~Patients received 20 mg/kg/day taken orally."
577703|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
577704|NCT00003590|O1|Outcome|Hydroxyurea|Patients received 20 mg/kg/day PO.
577705|NCT00003590|E1|Reported Event|Hydroxyurea|Patients received Hydroxyurea (20 mg/kg/day orally) up to 2 years in absence of progressive disease.
577706|NCT00003483|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577707|NCT00003483|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577708|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577709|NCT00003483|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577710|NCT00003483|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a meningioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577711|NCT00003479|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577712|NCT00003479|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577713|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577714|NCT00003479|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577715|NCT00003479|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with an ependymoma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577716|NCT00003477|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
577717|NCT00003477|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal)."
577718|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
577719|NCT00003477|O1|Outcome|Antineoplaston Therapy|Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
577720|NCT00003477|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a visual pathway glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577721|NCT00003475|B1|Baseline|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577820|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577825|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577722|NCT00003475|P1|Participant Flow|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577723|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577724|NCT00003475|O1|Outcome|Antineoplaston Therpay|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
577725|NCT00003475|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a primary malignant brain tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
577726|NCT00003473|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577727|NCT00003473|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal, to mitigate adverse reactions to treatment, until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577728|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577729|NCT00003473|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577730|NCT00003473|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a recurrent or refractory mixed glioma will receive Antineoplaston therapy (Atengenal + Astugenal)."
577731|NCT00003470|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
577732|NCT00003470|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577733|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
577734|NCT00003470|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal).~The daily doses of A10 and AS2-1 are divided into six infusions, which are given at 4-hourly intervals. Each infusion starts with infusion of A10 and is immediately followed by infusion of AS2-1."
577735|NCT00003470|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with an anaplastic astrocytoma that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577821|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
578396|NCT00000125|E1|Reported Event|Observation|Observation only from February 1994 to June 2002 .
577736|NCT00003468|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577737|NCT00003468|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a low-grade astrocytoma who have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577738|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577739|NCT00003468|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577740|NCT00003468|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a low grade astrocytoma that have not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577741|NCT00003460|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577742|NCT00003460|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577743|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577744|NCT00003460|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577745|NCT00003460|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a primitive neuroectodermal tumor that has not responded to standard therapy will receive Antineoplaston therapy (Atengenal + Astugenal)."
577746|NCT00003459|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577747|NCT00003459|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577748|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577749|NCT00003459|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577750|NCT00003459|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dosage is reached.~Antineoplaston therapy (Atengenal + Astugenal): Patients with a brain stem glioma will receive Antineoplaston therapy (Atengenal + Astugenal)"
577751|NCT00003458|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577752|NCT00003458|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577753|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577754|NCT00003458|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577755|NCT00003458|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Children with a brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577756|NCT00003457|B1|Baseline|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577757|NCT00003457|P1|Participant Flow|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577758|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577759|NCT00003457|O1|Outcome|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577760|NCT00003457|E1|Reported Event|Antineoplaston Therapy|"Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.~Antineoplaston therapy (Atengenal + Astugenal): Adults with a persistent or recurrent brain tumor will receive Antineoplaston therapy (Atengenal + Astugenal)."
577761|NCT00003389|B3|Baseline|Total|Total of all reporting groups
577762|NCT00003389|B2|Baseline|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
577763|NCT00003389|B1|Baseline|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
577764|NCT00003389|P2|Participant Flow|Arm B (Stanford V)|"Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Vincristine: given IV~Mechlorethamine: given IV~Etoposide: given IV~Prednisone: taken orally~Cyclophosphamide: given IV~Radiotherapy"
577765|NCT00003389|P1|Participant Flow|Arm A (ABVD)|"Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.~Doxorubicin: given IV~Bleomycin: given IV~Vinblastine: given IV~Dacarbazine: given IV~Radiotherapy"
577766|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
577822|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577823|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577767|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
577768|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
577769|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
577770|NCT00003389|O2|Outcome|Arm B (Stanford V)|Arm B (Stanford V): Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
577771|NCT00003389|O1|Outcome|Arm A (ABVD)|Arm A (ABVD): Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
577772|NCT00003389|E2|Reported Event|Arm B (Stanford V)|Patients receive Stanford V chemotherapy comprising doxorubicin (25 mg/m²) and vinblastine (6 mg/m²) IV on day 1 of weeks 1, 3, 5, 7, 9, and 11; vincristine (1.4 mg/m²) and bleomycin (5 u/m²) IV on day 1 of weeks 2, 4, 6, 8, 10, and 12; mechlorethamine (6 mg/m²) IV on day 1 of weeks 1, 5, and 9 (if mechlorethamine is unavailable, may substitute with cyclophosphamide [375 mg/m²] IV); etoposide (60 mg/m²) IV on days 1 and 2 of weeks 3, 7, and 11; and oral prednisone (40 mg/m²) every other day of weeks 1-9 followed by a taper. All patients with bulky disease receive radiotherapy 2-3 weeks after completion of chemotherapy.
577773|NCT00003389|E1|Reported Event|Arm A (ABVD)|Patients receive doxorubicin (25 mg/m²), bleomycin (10 u/m²), vinblastine (6 mg/m²), and dacarbazine (375 mg/m²) intravenously (IV) on days 1 and 15. Courses repeat every 28 days. Patients are restaged after 4 courses. Patients who are in complete remission receive 2 additional courses. Patients with a partial response or less are evaluated after 6 courses, and if there is an ongoing response, patients may receive 2 additional courses for a total of 8. If no ongoing response is observed, patients are removed from the study. All patients with massive mediastinal disease, regardless of stage, receive radiotherapy 2-3 weeks after completion of chemotherapy.
577774|NCT00003377|B6|Baseline|Total|Total of all reporting groups
577775|NCT00003377|B5|Baseline|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
577776|NCT00003377|B4|Baseline|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
577777|NCT00003377|B3|Baseline|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577778|NCT00003377|B2|Baseline|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577779|NCT00003377|B1|Baseline|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
577780|NCT00003377|P5|Participant Flow|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577781|NCT00003377|P4|Participant Flow|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
577782|NCT00003377|P3|Participant Flow|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
577783|NCT00003377|P2|Participant Flow|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577784|NCT00003377|P1|Participant Flow|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
577785|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577786|NCT00003377|O1|Outcome|Arm 2, P I & II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577787|NCT00003377|O5|Outcome|Arm 2, PII|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577788|NCT00003377|O4|Outcome|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
577789|NCT00003377|O3|Outcome|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
577790|NCT00003377|O2|Outcome|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577791|NCT00003377|O1|Outcome|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
577792|NCT00003377|E5|Reported Event|Arm 2, P II|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577793|NCT00003377|E4|Reported Event|Arm 4, P I|Cisplatin 30 mg/m2, plus Paclitaxel 50 mg/m2
577794|NCT00003377|E3|Reported Event|Arm 3, P I|Cisplatin 40 mg/m2, plus Paclitaxel 50 mg/m2
577795|NCT00003377|E2|Reported Event|Arm 2, P I|Cisplatin 40 mg/m2, plus Paclitaxel 40 mg/m2
577796|NCT00003377|E1|Reported Event|Arm 1, P I|Cisplatin 40 mg/m2, plus Paclitaxel 30 mg/m2
577824|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577797|NCT00003298|B1|Baseline|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577798|NCT00003298|P1|Participant Flow|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577799|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577800|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577801|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577802|NCT00003298|O1|Outcome|Experimental Arm|Patients receive 3 courses of preoperative neoadjuvant chemotherapy (an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel) given on day 1 every 21 days. Patients then undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577803|NCT00003298|E2|Reported Event|Step 2 (Adjuvant Therapy)|After neoadjuvant therapy, patients undergo surgery for tumor removal on day 63, followed 4-6 weeks later by one course of daily intravenous bolus leucovorin calcium and fluorouracil for 5 days. Chemotherapy is repeated 4-6 weeks later for the first 4 days of week 1 and the last 3 days of week 5 of radiation therapy given 5 days a week for 5 weeks. Patients receive two more courses, 4 weeks apart, of fluorouracil and leucovorin calcium for 5 days 4-6 weeks after completing radiation treatment.
577804|NCT00003298|E1|Reported Event|Step 1(Neoadjuvant Therapy)|Patients receive 3 courses of preoperative neoadjuvant chemotherapy given on day 1 every 21 days. Courses consist of an intravenous infusion of cisplatin and a 3 hour intravenous infusion of paclitaxel on day 1.
577805|NCT00003224|B7|Baseline|Total|Total of all reporting groups
577806|NCT00003224|B6|Baseline|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577807|NCT00003224|B5|Baseline|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577808|NCT00003224|B4|Baseline|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577809|NCT00003224|B3|Baseline|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577810|NCT00003224|B2|Baseline|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577811|NCT00003224|B1|Baseline|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577812|NCT00003224|P6|Participant Flow|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577813|NCT00003224|P5|Participant Flow|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577814|NCT00003224|P4|Participant Flow|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577815|NCT00003224|P3|Participant Flow|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577816|NCT00003224|P2|Participant Flow|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577817|NCT00003224|P1|Participant Flow|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577818|NCT00003224|O6|Outcome|Group 6. p946/Tet-p Plus IFA|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577819|NCT00003224|O5|Outcome|Group 5: p946/Tet-p Plus QS-21|282 mcg gp100 [280-288]/tetanus peptide conjugate, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577826|NCT00003224|O4|Outcome|Group 4. p946, Tet-p Plus IFA|100 mcg peptide gp100 [280-288], 190 mcg tetanus peptide, plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577827|NCT00003224|O3|Outcome|Group 3: p946 Plus Tet-p Plus QS-21|100 mcg peptide gp100 [280-288],190 mcg tetanus peptide, plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577828|NCT00003224|O2|Outcome|Group 2. p946 Plus IFA|100 mcg peptide gp100 [280-288] plus 0.5 ml IFA (Montanide ISA-51) vaccine adjuvant
577829|NCT00003224|O1|Outcome|Group 1: Peptide 946 Plus QS-21|100 mcg peptide gp100 [280-288] plus 0.2 ml (100 mcg) QS-21 vaccine adjuvant
577830|NCT00003224|O2|Outcome|All Montanide ISA-51|The toxicities are grouped for those receiving the vaccine adjuvant IFA (Montanide ISA-51).
577831|NCT00003224|O1|Outcome|All QS-21|The toxicities are grouped for those receiving the vaccine adjuvant QS-21.
577832|NCT00003224|E2|Reported Event|Montanide ISA-51 Adjuvant|The combination of participants from Arms 2, 4, and 6, all treated with peptides plus Montanide ISA-51 adjuvant
577833|NCT00003224|E1|Reported Event|QS-21 Adjuvant|The combination of participants from Arms 1, 3, and 5, all treated with peptides plus QS-21 adjuvant
577834|NCT00003222|B3|Baseline|Total|Total of all reporting groups
577835|NCT00003222|B2|Baseline|Peptides in GMCSF-in-adjuvant|
577836|NCT00003222|B1|Baseline|Peptides Pulsed on Dendritic Cells|
577837|NCT00003222|P2|Participant Flow|Peptides in Sargramostim (GMCSF)-In-Montanide ISA-51 Adjuvant|---Peptides were administered in an emulsion of sargramostim (GM-CSF) and Montanide ISA-51 (incomplete Freund's) adjuvant
577838|NCT00003222|P1|Participant Flow|Peptides Pulsed on Dendritic Cells|---peptides were pulsed on monocyte-derived dendritic cells cultures in GM-CSF and IL-4
577839|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
577840|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
577841|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
577842|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
577843|NCT00003222|O2|Outcome|Peptides in GMCSF-in-adjuvant|
577844|NCT00003222|O1|Outcome|Peptides Pulsed on Dendritic Cells|
577845|NCT00003222|E2|Reported Event|Peptides in GMCSF-in-adjuvant|
577846|NCT00003222|E1|Reported Event|Peptides Pulsed on Dendritic Cells|
577847|NCT00003138|B3|Baseline|Total|Total of all reporting groups
577848|NCT00003138|B2|Baseline|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577849|NCT00003138|B1|Baseline|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577850|NCT00003138|P2|Participant Flow|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577851|NCT00003138|P1|Participant Flow|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577852|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577853|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577854|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577855|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577856|NCT00003138|O2|Outcome|Erythropoietin|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577857|NCT00003138|O1|Outcome|Supportive Care|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577858|NCT00003138|E5|Reported Event|Erythropoietin (300 Units/kg) and Filgrastim (Step 4)|All patients received erythropoietin (150 units/kg) and filgrastim may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, increased their dose of erythropoietin to 300 units/kg.
577859|NCT00003138|E4|Reported Event|Erythropoietin (150 Units/kg) and Filgrastim (Step 3)|All patients received erythropoietin alone treatment may, at progression or at stable disease with continued transfusion requirement following 4 months of therapy, add filgrastim.
577927|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
578220|NCT00001213|B1|Baseline|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
577860|NCT00003138|E3|Reported Event|Erythropoietin (Cross-over; Step 2)|Patients in the supportive care arm who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm. Erythropoietin was administered at 150 units/kg subcutaneously every day.
577861|NCT00003138|E2|Reported Event|Erythropoietin (Step 1)|Erythropoietin was administered at 150 units/kg subcutaneously every day. If patients stopped responding, they were subsequently treated with Erythropoietin (150 units/kg) and filgrastim and then Erythropoietin (300 units/kg) and filgrastim.
577862|NCT00003138|E1|Reported Event|Supportive Care (Step 1)|Patients received red cell and platelet transfusions for symptoms or to maintain hematocrit at or above 25% by volume. Patients who required transfusion support for symptomatic anemia prior to entering the study and who developed an increase in their transfusion requirement of >= 50% shall cross over to the Erythropoietin treatment arm, after at least four months on the supportive therapy arm.
577863|NCT00002975|B1|Baseline|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
577864|NCT00002975|P1|Participant Flow|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
577865|NCT00002975|O1|Outcome|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
577866|NCT00002975|E1|Reported Event|Photodynamic Therapy Using 20% Topical ALA|4-6h and 18-24h, 20%, ALA application of superficial and nodular epidermally-derived lesions using ca 633 nm laser irradiation
577867|NCT00002931|B1|Baseline|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577868|NCT00002931|P1|Participant Flow|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577869|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577870|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577871|NCT00002931|O1|Outcome|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577928|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
578312|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
577872|NCT00002931|E1|Reported Event|HD Chemo and Auto Stem Cells|Cycle 1, stem cell mobilization with granulocyte-colony stimulating factor (G-CSF) at 10 μg/kg/d subcutaneously prior to leukapheresis. G-CSF administration daily during collection until the total collected product excelled 4 × 106 CD34+ cells/kg. 24-hour IV infusion of paclitaxel at 350 mg/m2 or 425 mg/m2 on day -7. Subsequent to this, patients receive etoposide (20 mg/kg IV over 2 hours) and carboplatin (AUC of 7 mg-min/mL IV over 30 minutes) daily on days -6, -5 and -4. IV infusion of 12.5% of the derived CD34+ stem cell product on day -2, followed by administration of 37.5% of the product on day 0. Cycle 2, comprised of paclitaxel, ifosfamide and carboplatin. Ifosfamide administered IV daily at 3 g/m2 over 30 minutes on days -6, -5 and -4. Mesna administered 24 hours subsequently as a 1 g/m2 bolus dose followed by 10g/m2 via continuous IV infusion over 72 hours. The derived CD34+ stem cell product administered in a manner identical to that during Cycle 1 on days -2 and 0.
577873|NCT00002850|B4|Baseline|Total|Total of all reporting groups
577874|NCT00002850|B3|Baseline|Observation|No prophylaxis: The patient will receive no prophylactic antibiotics.
577875|NCT00002850|B2|Baseline|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
577876|NCT00002850|B1|Baseline|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
577877|NCT00002850|P3|Participant Flow|Observation|Patients observed without intervention and evaluated for SBI for the first 2 months of treatment.
577878|NCT00002850|P2|Participant Flow|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
577879|NCT00002850|P1|Participant Flow|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
577880|NCT00002850|O3|Outcome|No Prophylaxis|The patient will receive no prophylactic antibiotics.
577881|NCT00002850|O2|Outcome|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
577882|NCT00002850|O1|Outcome|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
577883|NCT00002850|E3|Reported Event|Observation|No Prophylaxis: The patient will receive no prophylactic antibiotics.
577884|NCT00002850|E2|Reported Event|TMP-SMX|trimethoprim-sulfamethoxazole: Begin oral Trimethoprim-sulfamethoxazole when they start chemotherapy for multiple myeloma. Assigned treatment consists of TMP-SMX (Septra® or Bactrim®) 1 DS tablet [TMP-SMX DS = 160 mg trimethoprim and 800 mg sulfamethoxazole] every 12 hours for two months..
577885|NCT00002850|E1|Reported Event|Ciprofloxacin or Ofloxacin|"ciprofloxacin: Begin oral ciprofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ciprofloxacin (Cipro® 500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy.~ofloxacin: Begin oral ofloxacin when they start chemotherapy for multiple myeloma. Assigned treatment consists of ofloxacin (500 mg po tablet every 12 hours for two months. The patient will continue to be observed one additional month on study continuing regular myeloma chemotherapy."
577886|NCT00002766|B3|Baseline|Total|Total of all reporting groups
577887|NCT00002766|B2|Baseline|L-20|"Standard Vincristine/Prednisone (L-20)"
577888|NCT00002766|B1|Baseline|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
577889|NCT00002766|P2|Participant Flow|L-20|"Standard Vincristine/Prednisone (L-20) Patients receive induction therapy consisting of vincristine IV on days 1, 8, 15, 22, and 29, oral prednisone 2-3 times daily on days 1-29, cyclophosphamide IV on day 5, doxorubicin IV on days 23-25 and 42, methotrexate intrathecally on days 3, 5, 13, 16, 32, and 34 and GM-CSF subcutaneously or IV over 4 hours beginning from days 7 and 27 and continuing until blood counts recover."
577890|NCT00002766|P1|Participant Flow|All-2|"ARA-C/High-Dose Mitoxantrone(All-2) Patients receive induction therapy consisting of cytarabine IV over 3 hours on days 1-5 with high-dose mitoxantrone IV on day 3 and methotrexate intrathecally on days 2 and 4. Patients receive sargramostim (GM-CSF) subcutaneously or IV over 4 hours beginning on day 7 and continuing until blood counts recover."
577891|NCT00002766|O2|Outcome|L-20|"Standard Vincristine/Prednisone (L-20)"
577892|NCT00002766|O1|Outcome|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
577893|NCT00002766|E2|Reported Event|L-20|"Standard Vincristine/Prednisone (L-20)"
577894|NCT00002766|E1|Reported Event|All-2|"ARA-C/High-Dose Mitoxantrone(All-2)"
577895|NCT00002601|B1|Baseline|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577896|NCT00002601|P1|Participant Flow|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577897|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577898|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577899|NCT00002601|O2|Outcome|Cycle 2|Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused
577900|NCT00002601|O1|Outcome|Cycle 1|Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.
577901|NCT00002601|O1|Outcome|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577902|NCT00002601|E1|Reported Event|Doxorubicin/Ifosfamide + Melphalan/CDDP + PSCT|"Cycle 1 Day -8 through Day -4 (96h) Doxorubicin 150 mg/m2 (CI) + Ifosfamide 14 g/m2 mixed with mesna (CI) Day -3 Mesna 3.5 g/m2 over 24 h Day -2 12.5% of stem cell reinfused.~Cycle2 Day -11 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -10 thru Day -6 G-CSF 5ug/kg Day -4 Melphalan 75 mg/m2 + Cisplatin 100 mg/m2 Day -3 12.5% if stem cell reinfused Day 0 37.5% of stem cell reinfused"
577903|NCT00002558|B3|Baseline|Total|Total of all reporting groups
577904|NCT00002558|B2|Baseline|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
577905|NCT00002558|B1|Baseline|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
577906|NCT00002558|P2|Participant Flow|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
577907|NCT00002558|P1|Participant Flow|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
577908|NCT00002558|O2|Outcome|Group B|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
577909|NCT00002558|O1|Outcome|Group A|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
577910|NCT00002558|E2|Reported Event|Group: B > 6 Cycles of Cisplatin|Group B: Prior Treatment Limited to > 6 Cycles of Cisplatin
577911|NCT00002558|E1|Reported Event|Group A: <= 6 Cycles of Cisplatin|Group A: Prior Treatment Limited to <= 6 Cycles of Cisplatin
577912|NCT00002540|B3|Baseline|Total|Total of all reporting groups
577913|NCT00002540|B2|Baseline|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577914|NCT00002540|B1|Baseline|Control|Participants receive standard medical care.
577915|NCT00002540|P2|Participant Flow|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577916|NCT00002540|P1|Participant Flow|Control|Participants receive standard medical care.
577917|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577918|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577919|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577920|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577921|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577922|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577923|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577924|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577925|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577926|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
578313|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
577929|NCT00002540|O1|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577930|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577931|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577932|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577933|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577934|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577935|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577936|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577937|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577938|NCT00002540|O2|Outcome|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577939|NCT00002540|O1|Outcome|Control|Participants receive standard medical care.
577940|NCT00002540|E1|Reported Event|Prostate Screening|Participants undergo blood sample collection for prostate specific antigen (PSA) analysis at baseline and annually for 5 years. Participants also undergo a digital rectal examination (DRE) at baseline and annually for 3 years.
577941|NCT00002525|B3|Baseline|Total|Total of all reporting groups
577942|NCT00002525|B2|Baseline|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577943|NCT00002525|B1|Baseline|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577944|NCT00002525|P2|Participant Flow|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5 fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5 leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577945|NCT00002525|P1|Participant Flow|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577946|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577947|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577948|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577949|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577992|NCT00001832|B12|Baseline|Cells IV + SQ IL-2 w/GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF (to shorten time to neutrophil recovery), reactivity not specified
578314|NCT00000392|O1|Outcome|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
577950|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577951|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577952|NCT00002525|O2|Outcome|No Perioperative 5-FU|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577953|NCT00002525|O1|Outcome|Perioperative 5-FU|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577954|NCT00002525|E4|Reported Event|Adjuvant Chemotherapy-- 5-FU+Leucovovin|"After surgery, patients with stage IIC or III disease enrolled between August 1993 and August 1997 receive the following adjuvant chemotherapy:~Levamisole: 50 mg PO TID Days 1-3 and Days 15-17; 50 mg PO TID x 3 days beginning Day 29, repeat every 14 days for 11 months.~5-FU: 450 mg/m²/day IV bolus for Days 1-5. 450 mg/m² IV bolus once weekly beginning Day 29, repeat weekly for a maximum of 11 months.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
577955|NCT00002525|E3|Reported Event|Adjuvant Chemotherapy-- 5-FU+Levamisolem|"Beginning 21-35 days after surgery, patients with stage IIC or III disease enrolled between September 1997 and May 2000 receive the following adjuvant chemotherapy:~Leucovorin: 20 mg/m² IV push days 1-5 5-FU: 425 mg/m² IV push days 1-5, give immediately after Leucovorin~A cycle of therapy consisted of 5 consecutive days of chemotherapy. Cycles were repeated at the end of 4 weeks (day 29), 8 weeks (day 57) and then every 4 weeks for a total of 6 cycles.~All patients with Dukes' B3/C disease for who adverse vents were collected were included in the analysis."
577956|NCT00002525|E2|Reported Event|Arm II (No Perioperative 5-FU)|"Patients receive no perioperative fluorouracil.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577957|NCT00002525|E1|Reported Event|Arm I (Perioperative 5-FU)|"Within 24 hours of the colon resection, patients receive perioperative fluorouracil intravenously (IV) over 24 hours for 7 days.~After surgery (beginning 21-35 days post-surgery), 5-FU was given at a dose of 425 mg/m^2 IV push on days 1-5, and leucovorin calcium was given at a dose of 20mg/m^2 IV push on days 1-5~fluorouracil: Perioperative 5-FU: 600 mg/m^2/d x 7 days continuous IV, beginning within 24 hours of surgery~After surgery, 5-FU was given 425 mg/m^2 IV push on days 1-5~leucovorin calcium: given after surgery at dose of 20mg/m^2 IV push on days 1-5"
577958|NCT00001984|B1|Baseline|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577959|NCT00001984|P1|Participant Flow|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577960|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577961|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577962|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577963|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577964|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577965|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577966|NCT00001984|O1|Outcome|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577967|NCT00001984|E1|Reported Event|Alemtuzumab and DSG|The recipients of live donor kidneys were treated perioperatively with alemtuzumab and DSG and followed postoperatively without maintenance immunosuppression.
577968|NCT00001962|B1|Baseline|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
578217|NCT00001262|E3|Reported Event|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
577969|NCT00001962|P1|Participant Flow|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period.The Diamond Blackfan anemia arm was closed due to lack of accrual.
577970|NCT00001962|O1|Outcome|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions to subjects diagnosed with moderate aplastic anemia (MAA), pure red cell aplasia (PRCA), Diamond Blackfan anemia (DBA), relapse and refractory severe aplastic anemia (SAA) will receive treatment.
577971|NCT00001962|E1|Reported Event|Daclizumab Hematologic Response|daclizumab, 1 mg/kg of body weight, will be given for a total of 5 intravenous infusions. The subjects diagnosed with moderate aplastic anemia, pure red cell aplasia, Diamond Blackfan anemia, relapse and refractory severe aplastic anemia will receive treatment. The subjects will be seen and receive the daclizumab infusion biweekly during the treatment period. The Diamond Blackfan anemia arm was closed due to lack of accrual.
577972|NCT00001959|B1|Baseline|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577973|NCT00001959|P1|Participant Flow|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577974|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577975|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577976|NCT00001959|O1|Outcome|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577977|NCT00001959|E1|Reported Event|Pirfenidone|During the study drug period of 12 months, patients will receive oral pirfenidone daily. For patients whose initial renal function is 50-80 ml/min as assessed by the MDRD equation, the initial pirfenidone dosage will be calculated at 40 mg/kg/d, with a maximum dose of 800 mg TID. For patients whose initial renal function is 30-50 ml/min, the initial dose will be 30 mg/kg/d. For patients whose initial renal function is between 15 and 30 ml/min, the initial dose will be 20 mg/kg/d.
577978|NCT00001941|B1|Baseline|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577979|NCT00001941|P5|Participant Flow|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577980|NCT00001941|P4|Participant Flow|Phase I - 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577981|NCT00001941|P3|Participant Flow|Phase I - 6 mg/kg Cohort|6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577982|NCT00001941|P2|Participant Flow|Phase I - 4 mg/kg Cohort|4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577983|NCT00001941|P1|Participant Flow|Phase I - 2 mg/kg Cohort|2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2
577984|NCT00001941|O1|Outcome|Phase I & II Cohorts (2-8 mg/kg)|Phase I - 2 mg/kg cohort 2 mg/kg daclizumab over 60 minutes intravenously on days 1 and 2 Phase I - 4 mg/kg cohort 4 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 6 mg/kg cohort 6 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase I - 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose Phase II- 8 mg/kg cohort 8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577985|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577986|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577987|NCT00001941|O1|Outcome|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577988|NCT00001941|E1|Reported Event|Phase II- 8 mg/kg Cohort|8 mg/kg daclizumab over 90 minutes intravenously on day 1, single dose
577989|NCT00001832|B15|Baseline|Total|Total of all reporting groups
577990|NCT00001832|B14|Baseline|Cells IV + SQ IL-2 w/GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF in patients with no reactivity
577991|NCT00001832|B13|Baseline|Cells IV + SQ IL-2 w/GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
577993|NCT00001832|B11|Baseline|Cells IV + MTD IL-2 no GCSF (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
577994|NCT00001832|B10|Baseline|Cells IV + MTD IL-2 no GCSF (gp100 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
577995|NCT00001832|B9|Baseline|Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
577996|NCT00001832|B8|Baseline|Cells IA + MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
577997|NCT00001832|B7|Baseline|Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF
577998|NCT00001832|B6|Baseline|Cells IA + MTD IL-2 (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IA + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + G-CSF
577999|NCT00001832|B5|Baseline|Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) + G-CSF (to shorten time to neutrophil recovery)
578000|NCT00001832|B4|Baseline|Cells IV + High-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
578001|NCT00001832|B3|Baseline|Cells IV + Low-Dose IV IL-2 (Initial)|Phase 1 IL-2 Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
578002|NCT00001832|B2|Baseline|Cells IV + Cyclophosphamide 60mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells IV
578003|NCT00001832|B1|Baseline|Cells IV + Cyclophosphamide 30mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x30mg/kg + Cells IV
578004|NCT00001832|P15|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
578005|NCT00001832|P14|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578006|NCT00001832|P13|Participant Flow|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
578007|NCT00001832|P12|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578008|NCT00001832|P11|Participant Flow|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
578009|NCT00001832|P10|Participant Flow|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
578010|NCT00001832|P9|Participant Flow|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578011|NCT00001832|P8|Participant Flow|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
578012|NCT00001832|P7|Participant Flow|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
578013|NCT00001832|P6|Participant Flow|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
578014|NCT00001832|P5|Participant Flow|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
578015|NCT00001832|P4|Participant Flow|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
578016|NCT00001832|P3|Participant Flow|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
578017|NCT00001832|P2|Participant Flow|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
578018|NCT00001832|P1|Participant Flow|Abl Cells in Culture|Peripheral blood mononuclear cells (PBMC) and/or tumor infiltrating lymphocytes (TIL) obtained by apheresis or lesion excision to be cloned and expanded in the lab. All patients were enrolled on Arm 0 and their cells were then sent to the lab. If the lab was able to manufacture the cell product then the patient was enrolled on one of the treatment arms.
578019|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
578020|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578021|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
578022|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578023|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
578024|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
578025|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578026|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
578027|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
578028|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
578029|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
578030|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
578031|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
578032|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
578033|NCT00001832|O14|Outcome|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
578034|NCT00001832|O13|Outcome|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578035|NCT00001832|O12|Outcome|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
578036|NCT00001832|O11|Outcome|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578058|NCT00001832|E3|Reported Event|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
578037|NCT00001832|O10|Outcome|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
578038|NCT00001832|O9|Outcome|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
578039|NCT00001832|O8|Outcome|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578040|NCT00001832|O7|Outcome|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
578041|NCT00001832|O6|Outcome|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
578042|NCT00001832|O5|Outcome|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
578043|NCT00001832|O4|Outcome|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
578044|NCT00001832|O3|Outcome|Abl Cells IV+Low Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (72,000 IU/kg q8h for a maximum of 15 doses)
578045|NCT00001832|O2|Outcome|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
578046|NCT00001832|O1|Outcome|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
578047|NCT00001832|E14|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (no Reactivity)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 ( IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + growth colony stimulating factor (G-CSF) in patients with no reactivity
578048|NCT00001832|E13|Reported Event|Abl Cells IV + SQ IL-2 With GCSF (MART-1 Reactive)|Abl Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) with granulocyte colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1) reactive) Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + SQ IL-2 (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578049|NCT00001832|E12|Reported Event|Abl Cells IV + SQ IL-2 With GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + subcutaneous (SQ) interleukin-2 (IL-2) (125,000 IU/kg/dose for 5 days for six weeks with 2 days rest per week) + granulocyte colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery), reactivity not specified
578050|NCT00001832|E11|Reported Event|Abl Cells IV+MTD IL-2 no GCSF (MART-1reactive)|Abl Cells intravenous (IV)+ maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF) (melanoma-associated antigen recognized by T cells (MART-1)reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + MART-1:26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578051|NCT00001832|E10|Reported Event|Abl Cells IV+MTD IL-2 no GCSF(gp100 Reactive)|Abl Cells intravenous (IV) + maximum tolerated dose (MTD) interleukin-2 (IL-2) no growth colony stimulating factor (GCSF)(gp100 reactive).Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells IV + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses) without G-CSF + gp100:209-217(210M) 1mg/day (2-8 days) in patients with gp100 reactive cells
578052|NCT00001832|E9|Reported Event|Abl Cells IV + MTD IL-2 no GCSF|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) without growth colony stimulating factor (G-CSF) (to determine if G-CSF has harmful effects when adoptively transferring lymphocytes following a nonmyeloablative chemotherapy regimen)
578053|NCT00001832|E8|Reported Event|Abl Cells IA+MTD IL-2 (MART-1 Reactive)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) + melanoma- associated antigen recognized by T cells (MART-1):26-35(27L) Peptide 1mg/day (5-8 days) in patients with MART-1 reactive cells
578054|NCT00001832|E7|Reported Event|Abl Cells IA + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF)
578055|NCT00001832|E6|Reported Event|Abl Cells IA + MTD (Prior Cells IV on 6)|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intra-arterial (IA) + intravenous (IV) interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) Prior Cells IV + growth colony stimulating factor (G-CSF)
578056|NCT00001832|E5|Reported Event|Abl Cells IV + MTD IL-2|Phase 2 Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV interleukin-2 (IL-2) (720,000 IU/kg q8h for a maximum of 12 doses) + growth colony stimulating factor (G-CSF) (to shorten time to neutrophil recovery)
578057|NCT00001832|E4|Reported Event|Abl Cells IV+High Dose IV IL-2 (Initial)|Phase 1 interleukin-2 (IL-2) Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV) + IV IL-2 (720,000 IU/kg q8h for a maximum of 12 doses)
578059|NCT00001832|E2|Reported Event|Abl Cells IV + Cyclophosphamide 60 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m2 + Cyclophosphamide 2x60mg/kg + Cells intravenous (IV)
578060|NCT00001832|E1|Reported Event|Abl Cells IV + Cyclophosphamide 30 mg/kg|Phase 1 Cyclophosphamide Dose Escalation: Fludarabine 5x25mg/m^2 + Cyclophosphamide 2x30mg/kg + Cells intravenous (IV)
578061|NCT00001723|B3|Baseline|Total|Total of all reporting groups
578062|NCT00001723|B2|Baseline|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578063|NCT00001723|B1|Baseline|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578064|NCT00001723|P2|Participant Flow|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578065|NCT00001723|P1|Participant Flow|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578066|NCT00001723|O4|Outcome|Placebo - Non-Hispanic Whites|Change in weight for Non-Hispanic White participants treated with placebo
578067|NCT00001723|O3|Outcome|Placebo - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with placebo
578068|NCT00001723|O2|Outcome|Orlistat - Non- Hispanic Whites|Change in weight for Non-Hispanic White participants treated with orlistat
578069|NCT00001723|O1|Outcome|Orlistat - Non-Hispanic Blacks|Change in weight for Non-Hispanic Black participants treated with orlistat
578070|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578071|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578072|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578073|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578074|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578075|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578076|NCT00001723|O2|Outcome|Placebo|"Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program~Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578077|NCT00001723|O1|Outcome|Orlistat|"Orlistat 120 mg TID for 6 months plus a behavioral weight loss program~Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months."
578078|NCT00001723|E2|Reported Event|Placebo|Matching placebo 120 mg TID x 6 months plus a behavioral weight loss program Placebo : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
578079|NCT00001723|E1|Reported Event|Orlistat|Orlistat 120 mg TID for 6 months plus a behavioral weight loss program Orlistat : Subjects receive drug for 6 months plus a 12 week intensive behavioral weight los program. Subjects return for monthly visits for 3 more months.
578080|NCT00001703|B1|Baseline|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
578081|NCT00001703|P1|Participant Flow|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
578082|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
578083|NCT00001703|O1|Outcome|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
578084|NCT00001703|E1|Reported Event|Group A-VHL Peptide and ISA-51 Adjuvant|Patients are vaccinated with 1000 micrograms of the mutant Von Hippel-Lindau (VHL) peptide administered subcutaneously along with Montanide ISA-51 adjuvant.
578085|NCT00001656|B3|Baseline|Total|Total of all reporting groups
578086|NCT00001656|B2|Baseline|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578087|NCT00001656|B1|Baseline|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578218|NCT00001262|E2|Reported Event|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578088|NCT00001656|P2|Participant Flow|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578089|NCT00001656|P1|Participant Flow|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578090|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578091|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578092|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578093|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578094|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578095|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578096|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578097|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578098|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578099|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578145|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
578100|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578101|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578102|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578103|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578104|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578105|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578106|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578107|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578108|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578109|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578110|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578111|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578146|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
578219|NCT00001262|E1|Reported Event|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578112|NCT00001656|O2|Outcome|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578113|NCT00001656|O1|Outcome|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578114|NCT00001656|E2|Reported Event|Clozapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578115|NCT00001656|E1|Reported Event|Olanzapine Group|All medications were given by mouth, in identical tablet form. Day 1, patient was given 5mg olanzapine or 12.5mg clozapine. Clozapine dose was then increased every other day, the first increase by 12.5mg (to a total dose of 25mg/day) and then in steps of 25mg. When the clozapine dose reached 150mg/day, the olanzapine dose was increased to 10mg/day. When the clozapine dose reached 300mg/day, the olanzapine dose was increased to 15mg/day. Further increases were guided by clinical judgment to a maximum of 20mg/day of olanzapine and 900mg/day of clozapine.
578116|NCT00001596|B3|Baseline|Total|Total of all reporting groups
578117|NCT00001596|B2|Baseline|Placebo|Subjects received placebo (3 pills), three times daily.
578118|NCT00001596|B1|Baseline|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578119|NCT00001596|P2|Participant Flow|Placebo|Subjects received placebo (3 pills), three times daily.
578120|NCT00001596|P1|Participant Flow|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578121|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578122|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578123|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578124|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578125|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578126|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578127|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578128|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578129|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578130|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578131|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578132|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578133|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578134|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578135|NCT00001596|O2|Outcome|Placebo|Subjects received placebo (3 pills), three times daily.
578136|NCT00001596|O1|Outcome|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578137|NCT00001596|E2|Reported Event|Placebo|Subjects received placebo (3 pills), three times daily.
578138|NCT00001596|E1|Reported Event|Pirfenidone|Subjects received pirfenidone 801 mg (3 pills of 267 mg each), three times daily.
578139|NCT00001586|B3|Baseline|Total|Total of all reporting groups
578140|NCT00001586|B2|Baseline|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
578141|NCT00001586|B1|Baseline|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
578142|NCT00001586|P2|Participant Flow|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered. Eligible to donate cells.
578143|NCT00001586|P1|Participant Flow|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
578144|NCT00001586|O2|Outcome|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
578215|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578216|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578147|NCT00001586|O1|Outcome|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
578148|NCT00001586|E2|Reported Event|Low-Intermediate Risk B-Cell Pts|Previously untreated low or intermediate risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients (pts) not requiring chemotherapy. No rituximab fludarabine administered.
578149|NCT00001586|E1|Reported Event|Intermediate-high Risk B-Cell Pts|Previously untreated intermediate or high risk B-cell chronic lymphocytic lymphoma (CLL)/small lymphocytic lymphoma (SLL) patients requiring chemotherapy. Rituximab 375 mg/m^2 by infusion on day 1, cycle 1 followed by fludarabine on day 2-6, 25 mg/m^2 day x 5 days administered as an intravenous push or intravenous piggyback over 10-30 minutes, repeated every 28 days.
578150|NCT00001575|B1|Baseline|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578151|NCT00001575|P1|Participant Flow|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578152|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578153|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578154|NCT00001575|O1|Outcome|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578155|NCT00001575|E1|Reported Event|Anti-Tac Yttrium 90-labeled Humanized Anti-Tac (90 Y-HAT)|"10 mCi (if a bone marrow transplant was part of the patient's previous therapy) or 15 mCi of yttrium labeled anti-TAC; followed by calcium trisodium Inj (Ca DTPA).~Ca-DTPA will be administered intravenously on Days 1-3 to clear the radioactive agent from the body"
578156|NCT00001566|B1|Baseline|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578157|NCT00001566|P1|Participant Flow|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578158|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578159|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578160|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578161|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578162|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578163|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578164|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578165|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578166|NCT00001566|O1|Outcome|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578167|NCT00001566|E1|Reported Event|Peptide Vaccine/Autologous T Cell Transplant/Indinavir Therapy|Patients receive oral indinavir sulfate 350 mg/m^2 administered every 8 hours; maximum dose i.e. 800 mg every 8 hours; peptide pulsed dendritic cells 1 x 10^6 injection; harvested autologous T cells (minimum dose 1 x 10^6/kg will be thawed rapidly in 37 degree water bath and infused sequentially over 5-15 minutes.
578168|NCT00001304|B3|Baseline|Total|Total of all reporting groups
578169|NCT00001304|B2|Baseline|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578170|NCT00001304|B1|Baseline|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578171|NCT00001304|P2|Participant Flow|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578172|NCT00001304|P1|Participant Flow|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578173|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578174|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578175|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578176|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578177|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578178|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578179|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578180|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578181|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578182|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578183|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578184|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578185|NCT00001304|O2|Outcome|PTH 1-34|PTH 1-34 given as 2 subcutaneous injections daily
578186|NCT00001304|O1|Outcome|Calcitriol and Calcium|Twice daily po calcitriol with calcium carbonate given 4 times daily
578187|NCT00001304|E2|Reported Event|Calcitriol & Calcium|"All patients received twice daily Calcitriol and Calcium 1000mg divided into four doses daily.~Calcitriol & Calcium"
578188|NCT00001304|E1|Reported Event|PTH 1-34|"All patients received twice daily synthetic Human Parathyroid Hormone 1-34.~PTH 1-34"
578189|NCT00001262|B4|Baseline|Total|Total of all reporting groups
578190|NCT00001262|B3|Baseline|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578191|NCT00001262|B2|Baseline|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578192|NCT00001262|B1|Baseline|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578193|NCT00001262|P3|Participant Flow|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578194|NCT00001262|P2|Participant Flow|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578195|NCT00001262|P1|Participant Flow|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578196|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578197|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578198|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578199|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578200|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578201|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578202|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578203|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578204|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578205|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578206|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578207|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578208|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578209|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578210|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578211|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578212|NCT00001262|O2|Outcome|Late|Classic Menkes disease: Copper histidine treatment beginning after 1 month of age and after onset of symptoms
578213|NCT00001262|O1|Outcome|Early|Classic Menkes disease: Copper histidine treatment beginning within 1 month of age
578214|NCT00001262|O3|Outcome|Mild|Milder variants of Menkes disease: Copper histidine treatment beginning late (L) and after onset of (milder) symptoms
578221|NCT00001213|P1|Participant Flow|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
578222|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
578223|NCT00001213|O1|Outcome|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
578224|NCT00001213|E1|Reported Event|Cysteamine Topical Solution|"Cysteamine topical solution administered hourly while awake in both eyes~Cysteamine"
578225|NCT00001151|B1|Baseline|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
578226|NCT00001151|P1|Participant Flow|Group 1|Patient has rickets (child) or osteomalacia (adult) of bone
578227|NCT00001151|O1|Outcome|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
578228|NCT00001151|E1|Reported Event|Group 1|Patient has rickets (cild) or osteomalacia (adult) of bone
578229|NCT00000620|B3|Baseline|Total|Total of all reporting groups
578230|NCT00000620|B2|Baseline|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578231|NCT00000620|B1|Baseline|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578232|NCT00000620|P8|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
578233|NCT00000620|P7|Participant Flow|Glycemia Trial: Standard Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
578234|NCT00000620|P6|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals (intensive control <120 mm Hg; standard control <140 mm Hg)."
578235|NCT00000620|P5|Participant Flow|Glycemia Trial: Standard Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
578236|NCT00000620|P4|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Placebo|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
578237|NCT00000620|P3|Participant Flow|Glycemia Trial: Intensive Control/Lipid Trial: Fenofibrate|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~Lipid Trial - Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 in combination with open label simvastatin. Blinded fenofibrate or placebo plus simvastatin includes double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2 or matching placebo in combination with open label simvastatin 20 - 40 mg/day."
578315|NCT00000392|E2|Reported Event|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
578238|NCT00000620|P2|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Standard Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
578239|NCT00000620|P1|Participant Flow|Glycemia Trial: Intensive Control/BP Trial: Intensive Control|"Glycemia Trial - Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.~BP Trial - Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals."
578240|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
578241|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
578242|NCT00000620|O2|Outcome|Lipid Trial: Placebo|Double blind administration of placebo matching either 160 mg/day in participants with eGFR ≥50 mL/min/1.73m^2 or 54 mg/day in participants with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
578243|NCT00000620|O1|Outcome|Lipid Trial: Fenofibrate|Double blind administration of 160 mg/day of fenofibrate in participants with estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73m^2 or 54 mg/day in patients with eGFR <50 mL/min/1.73m^2, in combination with open label simvastatin 20 - 40 mg/day.
578244|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level to <140 mm Hg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
578245|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive medications as needed to reach Blood Pressure Trial arm-specific goals.
578246|NCT00000620|O2|Outcome|BP Trial: Standard Control|Open label administration of multiple anti-hypertensive agents to maintain SBP level <140 mm Hg. Anti-hypertensive agents multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
578247|NCT00000620|O1|Outcome|BP Trial: Intensive Control|Open label administration of anti-hypertensive agents to reduce and maintain systolic blood pressure (SBP) level to <120 mmHg. Anti-hypertensive agents include multiple anti-hypertensive agents as needed to reach Blood Pressure Trial arm-specific goals.
578248|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578249|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578250|NCT00000620|O2|Outcome|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578251|NCT00000620|O1|Outcome|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578252|NCT00000620|E2|Reported Event|Glycemia Trial: Standard Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578253|NCT00000620|E1|Reported Event|Glycemia Trial: Intensive Control|Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels <6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals.
578254|NCT00000575|B4|Baseline|Total|Total of all reporting groups
578255|NCT00000575|B3|Baseline|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578256|NCT00000575|B2|Baseline|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578257|NCT00000575|B1|Baseline|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578258|NCT00000575|P3|Participant Flow|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578259|NCT00000575|P2|Participant Flow|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578260|NCT00000575|P1|Participant Flow|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578261|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578262|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578263|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578264|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578265|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578266|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578267|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578268|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578269|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578270|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578271|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578272|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578273|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578274|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578275|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578276|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578277|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578278|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578279|NCT00000575|O3|Outcome|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578280|NCT00000575|O2|Outcome|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578281|NCT00000575|O1|Outcome|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578282|NCT00000575|E3|Reported Event|3 Placebo|Two 100 microgram puffs budesonide placebo bid + two 90 microgram puffs albuterol prn or four 2 mg puffs nedocromil placebo bid + two 90 microgram puffs albuterol prn.
578283|NCT00000575|E2|Reported Event|2 Nedocromil|Nedocromil (Tilade), four 2 mg puffs bid + two 90 microgram puffs albuterol prn
578284|NCT00000575|E1|Reported Event|1 Budesonide|Budesonide (Pulmicort), two 100 microgram puffs bid + two microgram puffs albuterol (Ventolin) prn
578285|NCT00000479|B5|Baseline|Total|Total of all reporting groups
578286|NCT00000479|B4|Baseline|Both Placebos|Placebo aspirin and placebo vitamin E
578287|NCT00000479|B3|Baseline|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
578288|NCT00000479|B2|Baseline|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
578289|NCT00000479|B1|Baseline|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
578290|NCT00000479|P4|Participant Flow|Both Placebos|Placebo aspirin and placebo vitamin E
578291|NCT00000479|P3|Participant Flow|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
578292|NCT00000479|P2|Participant Flow|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
578293|NCT00000479|P1|Participant Flow|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
578294|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
578295|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
578296|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
578297|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
578298|NCT00000479|O4|Outcome|Both Placebos|Placebo aspirin and placebo vitamin E
578299|NCT00000479|O3|Outcome|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
578300|NCT00000479|O2|Outcome|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
578301|NCT00000479|O1|Outcome|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
578302|NCT00000479|E4|Reported Event|Both Placebos|Placebo aspirin and placebo vitamin E
578303|NCT00000479|E3|Reported Event|Aspirin + Vitamin E|Aspirin (100 mg every other day) and vitamin E (600 IU every other day)
578304|NCT00000479|E2|Reported Event|Vitamin E Only|Placebo aspirin and vitamin E (600 IU every other day
578305|NCT00000479|E1|Reported Event|Aspirin Only|Aspirin(100 mg every other day)and placebo vitamin E
578306|NCT00000392|B3|Baseline|Total|Total of all reporting groups
578307|NCT00000392|B2|Baseline|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
578308|NCT00000392|B1|Baseline|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
578309|NCT00000392|P2|Participant Flow|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
578310|NCT00000392|P1|Participant Flow|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
578311|NCT00000392|O2|Outcome|Placebo|"Placebo given intranasally at a dosage of 2mg 3 times a day for 6 months~Placebo"
578316|NCT00000392|E1|Reported Event|Peptide T|"Peptide T given intranasally at a dosage of 2mg 3 times a day for 6 months~Peptide T"
578317|NCT00000378|B3|Baseline|Total|Total of all reporting groups
578318|NCT00000378|B2|Baseline|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
578319|NCT00000378|B1|Baseline|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
578320|NCT00000378|P2|Participant Flow|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
578321|NCT00000378|P1|Participant Flow|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
578322|NCT00000378|O2|Outcome|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
578323|NCT00000378|O1|Outcome|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
578324|NCT00000378|E2|Reported Event|Nortriptyline|"patients randomized to nortriptyline dose adjusted to therapeutic level~Nortriptyline: 12 week trial dose adjusted to therapeutic level"
578325|NCT00000378|E1|Reported Event|Sertaline|"patients randomized to sertraline 12 week trial does up to 200mgs~Sertraline: 12 week trial dose up to 200mgs"
578326|NCT00000371|B3|Baseline|Total|Total of all reporting groups
578327|NCT00000371|B2|Baseline|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
578328|NCT00000371|B1|Baseline|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
578329|NCT00000371|P2|Participant Flow|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
578330|NCT00000371|P1|Participant Flow|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
578331|NCT00000371|O2|Outcome|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
578332|NCT00000371|O1|Outcome|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
578333|NCT00000371|E2|Reported Event|Placebo|Patients were given 50 mg of placebo daily in addition to their treatment as usual with conventional neuroleptics.
578334|NCT00000371|E1|Reported Event|D-Cycloserine|Patients were given 50 mg of D-Cycloserine daily in addition to their treatment as usual with conventional neuroleptics.
578335|NCT00000143|B3|Baseline|Total|Total of all reporting groups
578336|NCT00000143|B2|Baseline|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
578337|NCT00000143|B1|Baseline|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
578338|NCT00000143|P2|Participant Flow|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
578339|NCT00000143|P1|Participant Flow|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
578340|NCT00000143|O2|Outcome|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
578341|NCT00000143|O1|Outcome|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
578342|NCT00000143|E2|Reported Event|Cidofovir IV (Intravenous)|"cidofovir intravenous (IV) start off with 5 mg/kg once weekly for two doses then followed by 5 mg/kg every other week~Cidofovir intravenous: intravenous, 5 mg/kg once weekly for two doses, followed by 5 mg/kg every other week"
578343|NCT00000143|E1|Reported Event|Ganciclovir Implant and Oral Ganciclovir|"Ganciclovir device and oral dose of Ganciclovir 1 gm three times daily~Ganciclovir implant and oral ganciclovir: oral ganciclovir, 1 gm three times daily"
578344|NCT00000142|B4|Baseline|Total|Total of all reporting groups
578345|NCT00000142|B3|Baseline|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578346|NCT00000142|B2|Baseline|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578347|NCT00000142|B1|Baseline|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578395|NCT00000125|E2|Reported Event|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents from February 1994 to June 2002.
578348|NCT00000142|P3|Participant Flow|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578349|NCT00000142|P2|Participant Flow|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578350|NCT00000142|P1|Participant Flow|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578351|NCT00000142|O3|Outcome|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578352|NCT00000142|O2|Outcome|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578353|NCT00000142|O1|Outcome|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578354|NCT00000142|E3|Reported Event|Cidofovir (High Dose)|"5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578355|NCT00000142|E2|Reported Event|Cidofovir (Low Dose)|"5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578356|NCT00000142|E1|Reported Event|Treatment Deferral|"IV (in the vein) treatment deferred until retinitis progressed, either:~5 mg/kg IV (in the vein) of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks, or~5mg/kg IV (in the vein) once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks.~Cidofovir: Three groups:~the deferral group, treatment deferred until retinitis progressed~Low-dose cidofovir group, 5 mg/kg of body weight once weekly for two weeks, then maintenance therapy with cidofovir, 3mg/kg once every 2 weeks.~High-dose cidofovir group, 5mg/kg once weekly for 2 weeks, then maintenance therapy with cidofovir, 5mg/kg once every two weeks."
578357|NCT00000136|B3|Baseline|Total|Total of all reporting groups
578358|NCT00000136|B2|Baseline|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578359|NCT00000136|B1|Baseline|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578360|NCT00000136|P2|Participant Flow|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578361|NCT00000136|P1|Participant Flow|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578362|NCT00000136|O2|Outcome|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578363|NCT00000136|O1|Outcome|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578364|NCT00000136|E2|Reported Event|Ganciclovir|"The induction dose for ganciclovir is 5 mg/kg every 12 hours. Full dose maintenance therapy for ganciclovir is 5 mg/kg every 24 hours, 7 days a week.~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578365|NCT00000136|E1|Reported Event|Foscarnet|"The induction dose for foscarnet is 60 mg/kg every 8 hours. Full dose maintenance therapy for foscarnet is 90 mg/kg/day~Foscarnet: 60 mg/kg every 8 hours, 90 mg/kg/day~Ganciclovir: 5 mg/kg every 12 hours, 5 mg/kg every 24 hours"
578366|NCT00000135|B3|Baseline|Total|Total of all reporting groups
578367|NCT00000135|B2|Baseline|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578368|NCT00000135|B1|Baseline|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578369|NCT00000135|P2|Participant Flow|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578370|NCT00000135|P1|Participant Flow|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578371|NCT00000135|O2|Outcome|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578372|NCT00000135|O1|Outcome|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578373|NCT00000135|E2|Reported Event|Placebo|"Placebo administered intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578374|NCT00000135|E1|Reported Event|MSL-109|"The dose MSL-109 administered by intravenous infusion every 2 weeks 60 mg.~MSL-109: 60 mg, IV (in vein) every two weeks, treatment continued until death or common closeout."
578375|NCT00000134|B4|Baseline|Total|Total of all reporting groups
578376|NCT00000134|B3|Baseline|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578377|NCT00000134|B2|Baseline|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
578378|NCT00000134|B1|Baseline|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578379|NCT00000134|P3|Participant Flow|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578380|NCT00000134|P2|Participant Flow|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
578381|NCT00000134|P1|Participant Flow|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578382|NCT00000134|O3|Outcome|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578383|NCT00000134|O2|Outcome|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
578384|NCT00000134|O1|Outcome|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578385|NCT00000134|E3|Reported Event|Combination Therapy|"combination therapy, wherein patients continued their previous therapy and were reinduced with the second drug and then placed on maintenance therapy with foscarnet at 90 mg/kg/day and ganciclovir at 5 mg/kg/day.~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578386|NCT00000134|E2|Reported Event|Intravenous Ganciclovir|"intravenous ganciclovir reinduction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day~Ganciclovir: intravenous ganciclovir induction at 5 mg/kg twice daily for 2 weeks followed by maintenance at 10 mg/kg/day"
578387|NCT00000134|E1|Reported Event|Intravenous Foscarnet|"intravenous foscarnet reinduction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day~Foscarnet: intravenous foscarnet induction at 90 mg/kg twice daily for 2 weeks, followed by maintenance therapy at 120 mg/kg/day"
578388|NCT00000125|B3|Baseline|Total|Total of all reporting groups
578389|NCT00000125|B2|Baseline|Treatment|Topical Antiglaucoma Agents: Topical Antiglaucoma Agents
578390|NCT00000125|B1|Baseline|Observation|Observation only
578391|NCT00000125|P2|Participant Flow|Treatment|Topical ocular hypotensive eye drops.
578392|NCT00000125|P1|Participant Flow|Observation|Close Observation
578393|NCT00000125|O2|Outcome|Treatment|Topical ocular hypotensive eye drops from February 1994 through March 2009.
578394|NCT00000125|O1|Outcome|Observation|Observation only from February 1994 through June 2002.Observation participants were offered topical antiglaucoma agents after June 2002 through study close out March 2009.
